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United States Patent Application |
20010053913
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Kind Code
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A1
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Freedland, Yosef
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December 20, 2001
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Adjustable button cinch anchor orthopedic fastener
Abstract
An orthopedic fastener device based on a strong central shaft that is
threaded in a one end region and that presents a ramp surface in the
other end region. The ramp end is inserted down-hole a bore in bone while
an expandable first collet having bendable circumferential flukes is snug
to the shaft, presenting a diameter less than the bore. Partial axial
withdrawal of the shaft from the bore forces the first collet into and
against the shaft's ramp region, causing the collet's flukes to splay and
strongly compressively engage the bone, thereby permanently anchoring the
fastener's first end. Soft tissue, normally a ligament, is slipped over
the shaft region extending beyond the bone, and is optionally grasped by
a toothed washer. Another, second, split collet--initially expanded in
its internal diameter that has and presents threads--slides along the
shaft so as to tension the ligament, compressing it in position against
the bone. A sleeve is forcibly slid over the second split collet by use
of a tool so as to contract the second split collet against the shaft,
locking tight the ligament against the bone at the position of the bore.
The second collet may thereafter be rotated on the shaft in the manner of
a screw so as to variably tension the ligament. Any and all parts may be
made from bio-absorbable materials.
Inventors: |
Freedland, Yosef; (Petah Tikual, IL)
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Correspondence Address:
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INNOVAR, LLC
P O BOX 250647
PLANO
TX
75025
US
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Serial No.:
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740577 |
Series Code:
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09
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Filed:
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December 18, 2000 |
Current U.S. Class: |
606/232; 411/337; 606/308; 606/309; 606/313; 606/327; 606/328 |
Class at Publication: |
606/73 |
International Class: |
A61B 017/56 |
Claims
What is claimed is:
1. An orthopedic fastening system for one tissue to another tissue, the
system comprising: a first elongate fastener that is affixable at a one
end thereof down-hole a bore present within a first tissue, the elongate
fastener having and presenting when so affixed an extension region that
extends beyond the bore; a split collet sliding along the fastener region
that extends beyond the bore so as to force a second tissue that has been
slipped over the fastener's extension region along this region and into
position against the first tissue; a sleeve forcibly sliding over the
split collet in its position upon the fastener's extension region so as
to contract the split collet against the fastener, thereafter locking the
split collet into position holding tight the second tissue against the
first tissue at the position of the bore.
2. The orthopedic fastening system according to claim 1 wherein the first
elongate fastener comprises: a shaft; wherein the fastener region that
extends beyond the bore is a length of the shaft.
3. The orthopedic fastening system according to claim 2 wherein the shaft
has and presents a ramp surface in a region that extends within the bore;
and wherein the first elongate fastener further comprises: an apertured
split collet having (i) a central aperture fitting snugly around the
shaft in the region thereof that extends within the bore, and (ii)
flukes, the split collet having and presenting a first diameter less than
the diameter of the bore until the shaft is forcibly moved transversely
in the aperture of the split collet so as to force the collet's flukes to
splay outward in greater separation from the central shaft, causing the
flukes to expand in diameter and to forcibly compress against the first
tissue that surrounds the bore.
4. The orthopedic fastening system according to claim 2 wherein the shaft
has and presents a ramp surface in a region that extends within the bore;
and wherein the first elongate fastener further comprises: an apertured
split collet having (i) a central aperture fitting snugly around the
shaft in the region thereof that extends within the bore, and (ii)
flukes, the split collet having and presenting a first diameter less than
the diameter of the bore until the shaft is forcibly moved transversely
in the aperture of the split collet so as to force the collet's flukes to
splay outward in greater separation from the central shaft, causing the
flukes to expand in diameter and to forcibly compress against the first
tissue that surrounds the bore.
5. The orthopedic fastening system according to claim 4 wherein the flukes
of the split collet splay outward so that their tips are towards the
entrance to the bore; wherein the collet with its splayed flukes strongly
resists extraction from the bore by pulling.
6. The orthopedic fastening system according to claim 2 wherein the shaft,
in its extension region, comprises: circumferential engagement features;
wherein the split collet engages the shafts engagement features when
contracted on and round about the shaft by action of the sleeve.
7. The orthopedic fastening system according to claim 6 wherein the
shaft's circumferential engagement features comprise: threads; wherein
the split collet screws upon the threads of the shaft when contracted on
and round about the shaft by action of the sleeve.
8. The orthopedic fastening system according to claim 6 wherein the
shaft's circumferential engagement features comprise: rachet pawls;
wherein the split collet locks upon the rachet pawls of the shaft when
contracted on and round about the shaft by action of the sleeve.
9. The orthopedic fastening system according to claim 1 wherein the first
elongate fastener is suitably sixed and shaped so as to be affixable at a
one end thereof down-hole a bore present within bone; and wherein the
second split collet is suitably sixed and shaped, in its sliding along
the fastener region that extends beyond the bore, so as to force a soft
tissue that has been slipped over the fastener's extension region along
this region and into position against the bone.
10. An orthopedic fastener for fastening a first tissue in which is
present a bore to a second tissue in which is present a hole, the
fastener comprising: a shaft having and defining from a first end to a
second end (i) a first circumferential surface region, (ii) a second
circumferential surface region, and (iii) a circumferential region with
engagement features; a first split collet initially encircling the shaft
at its second circumferential surface region; a deployment sleeve
temporarily fitting over the shaft to force the first split collet from
the second to the first circumferential surface region of the shaft while
the first end of the shaft remains inserted in the bore within the first
tissue, the split collet expanding during sliding from the second to the
first circumferential surface region so as to become affixed within the
bore; a second split collet for sliding along the shaft from the second
end towards the first end that is affixed within the bore so that the
second tissue that has its hole slipped over the shaft is forced along
the shaft and into position against the first tissue; a sleeve forcibly
sliding over the second split collet in its position upon the shaft so as
to contract the second split collet to the shaft, locking the second
split collet into position holding tight the second tissue against the
first tissue at the position of the bore; wherein the first split collet
expands while the second split collet contracts in order that each
performs a holding function.
11. An orthopedic fastener comprising: an elongate shaft having and
defining circumferential engagement features, the shaft mountable at a
one end region thereof to a first tissue of the body so that a remaining
portion of the shaft with its circumferential engagement features extends
beyond this first tissue; a split collet having and defining (i) an
interior bore of a larger diameter than is the shaft with its
circumferential engagement features, by which bore the split collet may
slip the extending portion of the shaft, (ii) a plurality of deformable
flukes at a split end of the collet, (iii) engagement features,
complimentary to the engagement features of the shaft, located internally
circumferentially on the collets plurality of flukes, and (iv) a ramp
surface located externally circumferentially on the collet's plurality of
flukes; and a sleeve in the shape of a hollow truncated frustaconical
body, the sleeve having and defining an internal bore of larger diameter
than is an external diameter of the split collet elsewhere from the
collet's plurality of flukes, and also an internally circumferential ramp
surface to the bore which ramp surface is complimentary in shape and in
diameter to the ramp surface of the collet's plurality of flukes; wherein
when the split collet is slid upon the extended portion of the elongate
shaft, and then the sleeve is slid forcibly over the split collet until
its interior ramp surface forcibly engages the exterior ramp surface of
the collet's plurality of flukes, then the plurality of flukes are
deformed until their internal circumferential engagement features engage
the complimentary engagement features of the extended shaft portion,
affixing the split collet to the shaft.
12. The fastener according to claim 11 wherein the elongate shaft's
circumferential engagement features comprise: threads; and wherein the
engagement features located internally circumferentially on the collet's
plurality of flukes comprise: threads; wherein the split collet is
affixable for threading the shaft.
13. The fastener according to claim 11 wherein the elongate shaft's
circumferential engagement features comprise: friction surface; and
wherein the engagement features located internally circumferentially on
the collet's plurality of flukes comprise: radial phalanges; wherein the
split collet is affixable to the shaft by compression of its phalanges
against the shaft.
14. The orthopedic fastening system according to claim 11 wherein the
shaft's circumferential engagement features comprise: rachet pawls;
wherein the split collet locks upon the rachet pawls of the shaft when
contracted on and round about the shaft by action of the sleeve.
15. The fastener according to claim 11 wherein the split collet further
has and defines an exterior circumferential engagement feature; wherein
the sleeve further has and defines an interior circumferential engagement
feature complimentary to the engagement feature of the collet; and
wherein when the sleeve is slid forcibly over the split collet then, by
engagement of the complimentary engagement features of collet and of
sleeve, the sleeve becomes engaged to the collet concurrently that the
collet becomes affixed to the shaft.
16. An orthopedic fastening system for one tissue to another tissue, the
system comprising: a first elongate fastener that extends through a bore
present within a first tissue, the elongate fastener having and
presenting when so extending (i) a first extension region extending
beyond the bore at a one side of the first tissue, which first extension
region has and defines an aperture through which aperture first suture is
passed to engage the elongate fastener to the first tissue, and (ii) a
second extension region oppositely extending beyond the bore at an
opposite side of the first tissue; a split collet sliding along the
fastener' second extension region that extends beyond the bore so as to
force a second tissue that has been slipped over the fastener's extension
region along this region and into position against the first tissue; a
sleeve forcibly sliding over the split collet in its position upon the
fastener's second extension region so as to contract the split collet
against the fastener, thereafter locking the split collet into position
holding tight the second tissue against the first tissue at the position
of the bore.
17. The orthopedic fastening system according to claim 16 wherein the
elongate fastener's second extension region comprises: a shaft having
circumferential engagement features; wherein the split collet engages the
shaft's engagement features when contracted on and round about the shaft
by action of the sleeve.
18. The orthopedic fastening system according to claim 16 wherein the
elongate fastener's second extension region comprises: a length of second
suture threading and held to a body of the fastener that is within the
bore; wherein the split collet compressively engages and holds the length
of second suture when contracted on and round about the length of second
suture by action of the sleeve.
19. An orthopedic fastening system for one tissue to another tissue, the
system comprising: a first elongate fastener that extends through a bore
present within a first tissue, the elongate fastener having and
presenting when so extending (i) a first extension region extending
beyond the bore at a one side of the first tissue, which first extension
region has and defines an pivoting member which member passes though the
bore and then pivots at the one side thereof so as to thereafter no
longer pass though the bore, and (ii) a second extension region
oppositely extending beyond the bore at an opposite side of the first
tissue; a split collet sliding along the fastener' second extension
region that extends beyond the bore so as to force a second tissue that
has been slipped over the fastener's extension region along this region
and into position against the first tissue; a sleeve forcibly sliding
over the split collet in its position upon the fastener's second
extension region so as to contract the split collet against the fastener,
thereafter locking the split collet into position holding tight the
second tissue against the first tissue at the position of the bore.
20. The orthopedic fastening system according to claim 19 wherein the
elongate fastener's second extension region comprises: a shaft having
circumferential engagement features; wherein the split collet engages the
shaft's engagement features when contracted on and round about the shaft
by action of the sleeve.
21. The orthopedic fastening system according to claim 19 wherein the
elongate fastener's second extension region comprises: a length of suture
anchored to the pivoting region an/d passing at least a part of the bore;
wherein the split collet compressively engages and holds the length of
suture when contracted on and round about suture by action of the sleeve.
22. The orthopedic fastening system according to claim 20 wherein the
elongate shaft's second extension region circumferential engagement
features comprise: threads; and wherein the collet further comprises:
threads located internally circumferentially on the plurality of flukes;
wherein the split collet is affixable for threading the shaft.
23. The orthopedic fastening system according to claim 20 wherein the
elongate shaft's second extension region circumferential engagement
features comprise: a friction surface; and wherein the collet further
comprises: radial phalanges located internally circumferentially on the
collet's plurality of flukes;/ wherein the split collet is affixable to
the shaft by compression of its phalanges against the shaft.
24. The orthopedic fastening system according to claim 20 wherein the
shaft's circumferential engagement features comprise: rachet pawls;
wherein the split collet locks upon the rachet pawls of the shaft when
contracted on and round about the shaft by action of the sleeve.
25. A method of variably selectively compressing in vivo a free end of a
soft tissue comprising: engaging in vivo the free end of the soft tissue
(i) about an elongate fastener that is affixed at a one end thereof
down-hole a bore present within another, second tissue, the elongate
fastener having and presenting when so affixed an extension region that
extends beyond the bore, and (ii) between, on the one hand, a sliding
lock means that both slides along the fastener region that extends beyond
the bore, and that locks and unlocks in its position upon the fastener's
extension region, and, on the other hand, the second tissue; first
sliding in vivo the sliding lock means in a selectable first position
along the fastener region that extends beyond the bore so as to compress
to a first variably selectable extent said soft tissue, which soft tissue
has been engaged about the fastener's extension region and between the
sliding lock means and the second tissue, into position against the first
tissue; and locking the sliding lock means in its selectable first
position, therein to compress the soft tissue against the second tissue
to a variably selectable first degree.
26. The method of variably selectively compressing in vivo a free end of a
soft tissue according to claim 25 expanded and extended to variably
selectively re-compressing in vivo the free end of the soft tissue, the
expanded and extended method further comprising: unlocking in vivo, at a
time after the locking, the locked sliding lock means in its first
selectable position along the fastener region; second sliding in vivo the
sliding lock means along the fastener region that extends beyond the bore
to a selectable second position so as to compress said soft tissue that
has been engaged about the fastener's extension region into position
against the first tissue to a second variably selectable degree that is
different from the first variably selectable degree; and re-locking the
sliding lock means at it's selectable second position, therein to
recompress the soft tissue against the second tissue to the variably
selectable second degree.
27. The expanded and extended method according to claim 26 wherein the
engaging in vivo comprises: forming an aperture in the free end of the
soft tissue; and slipping the aperture of the free end of the soft tissue
over an end of the elongate fastener opposite to that end of the fastener
that is affixed down-hole the bore.
28. The expanded and extended method according to claim 26 wherein the
engaging is of the free end of a tendon.
29. The expanded and extended method according to claim 26 wherein the
engaging is of the free end of a ligament.
30. The expanded and extended method according to claim 26 wherein the
engaging is of the free end of a joint capsule.
31. The expanded and extended method according to claim 26 wherein the
engaging is of the free end of the soft tissue about a first elongate
fastener that is affixed at a one end thereof down-hole a bore present
within bone.
32. A method of variably selectively tensioning in vivo a soft tissue to
another, second, tissue, the method comprising: engaging in vivo a soft
tissue (i) about an elongate fastener that is affixed at a one end
thereof down-hole a bore present within another, second tissue, the
elongate fastener having and presenting when so affixed an extension
region that extends beyond the bore, and (ii) between, on the one hand, a
sliding lock means that both slides along the fastener region that
extends beyond the bore, and that locks and unlocks in its position upon
the fastener's extension region, and, on the other hand, the second
tissue; first sliding in vivo the sliding lock means in a selectable
first position along the fastener region that extends beyond the bore so
as to tension to a first variably selectable extent said soft tissue,
which soft tissue has been engaged about the fastener's extension region
and between the sliding lock means and the second tissue, into position
proximate to the first tissue; and locking the sliding lock means in its
selectable first position, therein to tension the soft tissue towards the
second tissue to a variably selectable first extent.
33. The method of variably selectively tensioning in vivo a free end of a
soft tissue according to claim 32 expanded and extended to variably
selectively re-tensioning in vivo the soft tissue, the expanded and
extended method further comprising: unlocking in vivo, at a time after
the locking, the locked sliding lock means in its first selectable
position along the fastener region; second sliding in vivo the sliding
lock means along the fastener region that extends beyond the bore to a
selectable second position so as to tension said soft tissue that has
been engaged about the fastener's extension region into position against
the first tissue to a second variably selectable extent that is different
from the first variably selectable extent; and re-locking the sliding
lock means at it's selectable second position, therein to retension the
soft tissue towards the second tissue to a variably selectable second
extent.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present application is divisional application of U.S. patent
application Ser. No. 08/601,177, filed Feb. 14, 1996, now U.S. Pat. No.
6,162,234, issued Dec. 19, 2000, which is a continuation-in-part
application of co-pending U.S. patent application Ser. No. 08/184,121,
filed on Feb. 11, 1995, which application is a continuation-in-part
application of U.S. patent application Ser. No. 08/034,269 filed Mar. 23,
1993, the entire disclosures of which are hereby incorporated by
reference.
FIELD OF THE INVENTION
[0002] The present invention relates to in vivo tissue fastening in which
one tissue is brought closer in respect to, and fastened to, a second
tissue.
[0003] The present invention particularly relates to the fastening of a
soft tissue to a hard tissue, such as tendon to bone, wherein, by sepaate
action transpiring at the two ends of a fastener device, (i) a one end of
a fastener is firmly permanently compressively anchored in the hard
tissue (bone) while (ii) a large area of the soft tissue (tendon) is
drawn toward the hard tissue--including by an efficient sliding
motion--at a selected tension (compression) force--including as may be
obtained by action of screw threads--so as to, typically, compress the
soft tissue (tendon) to the hard tissue (bone) at an adjustably variable
compression force.
[0004] The present invention still further particularly relates to
fasteners for the fastening of a soft tissue to a hard tissue, such as
tendon to bone, that are both (i) physically substantial and robust in
all sections, and (ii) exhibit bending and torsional movements, that are
in all respects eminently suitable for implementation in certain plastic
and/or in collagen (artificial bone) materials that, nonetheless to being
well tolerated by and absorbable within the body, are neither so
physically strong nor so flexible as are, for example, metals.
BACKGROUND OF THE INVENTION
[0005] Since the middle of this century, orthopedic research has advanced
and proven the importance of "primary" bone union versus "non-primary"
bone union. The former connotes a healing in which the bone portions are
held in close alliance and with rigidity and stability in relationship to
each other. With these conditions met, the fractured bone will
immediately bridge the gap between the bone pieces so that all the new
bony material is dedicated to bridging and virtually none is wasted to
create a temporary "splint" of material around the fractured bone.
[0006] Non-primary bone healing occurs when the bone portions are not held
rigidly with respect to each other. In this case, the bone cells will
initially lay down a doughnut-shaped "splint" of bone-like material
around the fractured pieces in order to create a rigid relationship
between the bone portions. Once the portions have been immobilized, the
bone cells will then become bridges. Finally, after this process is
completed, the bone will gradually resorb the doughnut-shaped splint.
[0007] Many companies manufacturing orthopedic appliances have created
metal bone plates and screws which, when deployed, create a stabile,
immobile environment for the bone portions, promoting the very desirable
primary bone fixation. While it has been shown that when the bone
portions at the fracture interface are brought within a close proximity,
there is optimal healing speed and achievement of optimal strength within
a short period of time, because of the nature of prior art screws--which
rely on non-measurable and often nonadjustable shear forces to accomplish
fixation--there has been little investigation into the optimal pressure
and gap in order to achieve the optimal healing speed and strength.
[0008] Various orthopedic fasteners are known which bring tissues closer
together. Spreading anchors are common, and are characterized by the
Mitek anchor which has fins which are compressed into a bore in the bone.
While it is pushed to its placement, the bore of the bone maintains the
fins in the compressed state. When the anchor has achieved its position,
the suture which is attached to the anchor is pulled upon so that the
fins spread outward into the adjacent bone and provide an anchoring. This
suture is then threaded into the soft tissue so that the soft tissue is
approximated to the bone. The suture is then tied to maintain the soft
tissue against the bone.
[0009] This common type of bone anchor has several drawbacks. First, the
fins of the device drag in the bone, likely leaving debris which will
cause body cells to congregate to remove the debris leading to bone
thinning around the implant, leading to implant movement over the long
term. Second, the suture is passed through the soft tissue and knotted,
and can create point pressure on the tissue and cut loose through the
strands of the tendon. Third, the ultimate strength of the anchor is
limited to the strength of the suture material which has a low pullout
failure strength. Fourth and finally, upon dissolution of the suture the
implant becomes an unattached moveable piece that can migrate through
bone.
[0010] A more recent orthopedic concept advanced has been to create a low
grade electrical current between fractured bones which are undergoing the
bridging process. The electrical current apparently does not influence
whether a primary or a non-primary union is created. However, the current
prompts the bone cells to begin the healing process, and speeds the
healing process once underway. A number of companies have developed
electromagnetic coils which are often placed around the skin nearest the
bone fracture which will help to guide the bones into a healthy healing.
[0011] Other factors which affect bone healing are the nutrients available
to the bone cells, the acid environment around the fractures, the potency
of the blood supply, the bone density and the area of the bone fracture,
whether at the spongy end bone, in the mid-shaft hard, tubular bone or in
flat bones characterized by the bones of the skull. Many of these factors
cannot be influenced by the orthopedic surgeon and generally, orthopedic
fixation technique has been directed towards (i) rigid plating in many
types of fractures and (ii) the use of elector-magnetic current in either
cases of soft bone (such as in geriatrics where there is an anticipated
slow healing process) or in multiple fracture fragments where there may
be bone fragments missing or crushed.
[0012] As noted, the screws used in this fixation, either of bone to bone,
tendon to bone, ligament to bone or joint capsule to bone, are generally
not adjustable in the compressive pressure that they apply to meld the
bone structures together. Yet it is clear that there is an optimal gap
configuration between bone portions and there is also an optimal pressure
between the bone portions which will promote the optimal healing
situation.
SUMMARY OF THE INVENTION
[0013] The present invention is embodied in orthopedic fixation devices
for bringing one object close to another by applying a selectively
adjustable compressive force on a surface or surfaces of tissue or,
equivalently, a selectively adjustable tension force tending to draw two
tissues closer together.
[0014] The orthopedic fastener devices of the present invention will be
seen to have combinations of bone anchors and "adjustable cinch buttons"
(as will be explained). These fastener devices will be seen to provide
easy-to-adjust compressive forces between two in vivo structures,
including adjustment at a time following implantation. A variety of
fastener devices will be seen to be presented, all designed to provide
various mechanisms for fixating in vivo structures through modified bone
anchors joined to a moveable button. Once the existence of fastener
devices in accordance with the present invention--which can easily
provide adjustable and easily replicated pressure on healing
portions--becomes known, it is the contention of this author that the
benefits of the theory of the fastener device will become appreciated,
and that further investigation into the optimal compression for the
healing pressure will be made so that surgeons can effectively heal even
the most difficult cases.
[0015] This concept of adjustable compression on healing in vivo
structures is believed to be most important in geriatric orthopedic
surgery where the patient has soft bones which do not heal quickly, but
at the same time, cannot be immobilized for long periods to promote
proper fixation without risking embolism or vascular accident. Once the
correct compressive force is determined, surgeons will have one more
important concept with which to influence the speed of healing.
[0016] The present invention will be seen to further relate to in vivo
tissue fastening in which one tissue is brought closer in respect to a
second tissue. In fastening a soft tissue to a hard tissue, such as
tendon to bone, the fastener device of the present invention will be seen
to be configured in a novel manner at both its ends. One embodiment of
the invention will be seen to consist of a shaft which has at one end (i)
a novel expandable collet which expands so as to provide anchoring to the
bone, and which has as a second end (ii) a "sliding button cinch anchor"
that brings a soft tissue toward the bone and then clamps against the
shaft, holding the tissue in position through compression of a large
surface area of tissue. Examination of particular prior art of relevance
to these features, as transpires in the next following sections, is thus
of relevance.
[0017] Yet another novel feature of the present invention will be seen to
be that the shaft and the "button cinch" can be threaded so that,
following the sliding of the button cinch onto and along the shaft, it
can be secured in such a manner as to be able to be screwed on the shaft
in the manner of a nut, providing incremental compression of the secured
tendon. In one embodiment of the fastener device of the present
invention, it will be seen that a hole can be drilled entirely through
the bone, one end of threaded shaft which ends in an eyelet or hook is
passed through the bore in the bone and attached to a tendon while a
threaded button cinch at the opposite end of the shaft sits on the bone
surface around the bore. The amount of tension applied to the tendon may
be adjusted through rotation of the threaded button on the shaft. The
particular prior art to this feature will also thus be of relevance.
BRIEF DESCRIPTION OF THE DRAWINGS
[0018] Referring particularly to the drawings for the purpose of
illustration only and not limitation, there is illustrated:
[0019] FIG. 1 is an elevational view of a threaded shaft of an adjustable
button cinch anchor orthopedic fastener of the present invention with a
first embodiment head (H1) and a first embodiment tail (T1).
[0020] FIG. 2 is front elevational view of a collet which surrounds the
threaded shaft, previously seen in FIG. 1, of the T1-H1 embodiment of the
adjustable button cinch anchor fastener of the present invention.
[0021] FIG. 3 is a cut-away view of the collet pictured in FIG. 2.
[0022] FIG. 4 is an elevational view of a spiked washer of the T1-H1
embodiment of the adjustable button cinch anchor fastener of the present
invention.
[0023] FIG. 5 ms an elevational view of a hoop which encircles the collet
to push the threads into the shaft threads in the T1-H1 embodiment of the
adjustable button cinch anchor fastener of the present invention.
[0024] FIG. 6 is a cut-away view of the hoop previously shown in FIG. 5.
[0025] FIG. 7 is a cut-away view of the hoop around a cut-away view of the
collet, the hoop being located in the pre-deployed position, in the T1-H1
embodiment of the adjustable button cinch anchor fastener of the present
invention.
[0026] FIG. 8 is a cut away view of the hoop which has advanced up the
shaft of the collet to compress the collet pawls radially inward.
[0027] FIG. 9 is a cut-away view of FIG. 8 in which the excess collet
below the hoop has been cut and is being removed.
[0028] FIG. 10 is an elevational view of the T1-H1 embodiment of the
adjustable button cinch anchor fastener in accordance with the present
invention in its pre-deployed position with its flukes in place.
[0029] FIG. 11 is a cut-away view of the threaded collet previously shown
in FIG. 10 where a ring which contacts the soft tissue does not have
threads present.
[0030] FIG. 12 is an elevational view of the T1-H1 embodiment of the
adjustable button cinch anchor fastener in its deployed position with the
flukes pushed upward to contact the upper table of the shaft and the
flukes splayed in the deployed position.
[0031] FIG. 13 is a cut-away view of the T1-H1 embodiment of the
adjustable button cinch anchor fastener in the deployed position
previously seen in FIG. 12.
[0032] FIG. 14 is an elevational view of the flukes of the T1-H1
embodiment of the adjustable button cinch anchor fastener in their
pre-deployed position.
[0033] FIG. 15 ms a cross sectional view of the flukes taken along lines
"A-A" of FIG. 14.
[0034] FIG. 16 is a cross-sectional view of the flukes taken along lines
"B-B" of FIG. 14.
[0035] FIG. 17 is an elevational view of the flukes of the T1-H1
embodiment of the adjustable button cinch anchor fastener in their
deployed position.
[0036] FIG. 18 is a cross-sectional view of the flukes taken along lines
"C-C" of FIG. 17.
[0037] FIG. 18 is underside view of the flukes taken along lines "D-D" in
FIG. 17.
[0038] FIG. 19 is a cross sectional view of the flukes taken along lines
"D-D" of FIG. 17.
[0039] FIG. 20 an elevational view of the T1-H1 embodiment of the
adjustable button cinch anchor fastener of the present invention showing
its flukes and its shaft in their deployed positions at a time following
the pressured deployment of the flukes by an accessory deployment sleeve,
the bone anchor being inserted into a cut-away view of the bone surface.
[0040] FIG. 21 is an elevational view of the T1-H1 embodiment of the
adjustable button cinch anchor fastener of the present invention with its
flukes and its shaft in their deployed positions holding a piece of soft
tissue, and with a spiked washer being aligned on the shaft of the
fastener, the elevational view being relative to a cross section of a
bone surface.
[0041] FIG. 22 is an elevational view of the T1-H1 embodiment of the
adjustable button cinch anchor fastener of the present invention with its
flukes and its shaft in their deployed positions holding a piece of soft
tissue, and with the spiked washer (previously seen in FIG. 21, now shown
in cross-section) being placed upon the shaft, the elevational view being
relative to a cross section of bone.
[0042] FIG. 23 is an elevational view of the T1-H1 embodiment of the
adjustable button cinch anchor fastener of the present invention with its
flukes and its shaft in their deployed positions holding a piece of soft
tissue, and with the spiked washer (previously seen in FIG. 21, again
shown in cross section) being aligned near a bone surface (shown in cross
section); a collet and a hoop of the adjustable button cinch anchor
fastener are shown being put into position on the fastener's shaft so
that the inner threads of the collet are adjacent to the outer threads on
the shaft of the fastener while the hoop has not yet been snapped into
its deployed position.
[0043] FIG. 24 is an elevational view of the T1-H1 embodiment of the
adjustable button cinch anchor fastener of the present invention with its
flukes and its shaft in their deployed positions holding a piece of soft
tissue (shown in cross section) and with the spiked washer in position
and with the collet; the hoop has been moved up the shaft of the fastener
and over the collet so that it is nearly snapped into final position.
[0044] FIG. 25 is a cross sectional view of the collet, washer and hoop of
FIG. 24 within the T1-H1 embodiment of the adjustable button cinch anchor
fastener, along with the tendon and the fastener's shaft in elevational
view.
[0045] FIG. 26 is an elevational view of the T1-H1 embodiment of the
adjustable button cinch anchor fastener of the present invention with its
flukes and its shaft in their deployed positions, and with its spiked
washer being held in position by the hoop snapped into place on the
collet so that pawls of the collet have been compressed into the threads
of the shaft, thereby to hold a piece of soft tissue.
[0046] FIG. 27 is a cross-sectional view of the collet and the hoop
previously seen in FIG. 26 along with an elevational view of the bone
anchor including the shaft, the view being relative to a cross section of
bone.
[0047] FIG. 28 is an elevational view of the T1-H1 embodiment of the
Adjustable Button Cinch anchor of the present invention previously seen
in FIG. 27 where the bone anchor with its flukes is in the deployed
position, soft tissue further being held in position by the button
anchor's (fastener's) spiked washer which is compressed by the button
anchor's (fastener's) collet which is in turn compressed by the button
anchor's (fastener's hoop); excess collet has been cut away from the
pawls which are compressed under the hoop.
[0048] FIG. 29 is a cutaway breakaway view of the spiked washer and hoop
and collet previously seen in FIG. 29 in accompaniment with an
elevational view of the anchor and shaft; note the excess collet shown in
cutaway breakaway view.
[0049] FIG. 30 is an elevational view of the T1-H1 embodiment of the
adjustable button cinch anchor fastener of the present invention with its
flukes and its shaft in their deployed positions in accompaniment with an
elevational view of the hoop and collet in their deployed positions; the
excess shaft of the anchor has been cut off and the collet is shown to be
able to rotate in order to apply varying amounts of pressure to the held
tendon.
[0050] FIG. 31 is a cross sectional view of the T1-H1 embodiment of the
adjustable button cinch anchor fastener of the present invention with its
flukes and its shaft in their deployed positions; a piece of soft tissue
is shown aligned and held near the a bone surface shown in cross-section.
[0051] FIG. 32 is an elevational view of a friction surface shaft of an
embodiment of the adjustable button cinch anchor fastener of the present
invention having the first embodiment head (H1) and a second embodiment
tail (T2).
[0052] FIG. 33 is a cross section of a collet and a hoop with parallel
ribs which contact the friction surface of the shaft of the H1-T2
embodiment of the adjustable button cinch anchor fastener of the present
invention previously depicted in FIG. 32.
[0053] FIG. 34 is a cut-away view of an embodiment of an adjustable button
cinch anchor fastener of the present invention having the first
embodiment head (H1) and a third embodiment tail (T3), the shaft of which
was previously depicted in FIG. 32 and the collet and hoop of which were
previously depicted in FIG. 33; the collet and hoop have been deployed
and the excess shaft and the excess collet have been cut off.
[0054] FIG. 35 is an elevational view of an alternative collet for the
T1-H3 embodiment of adjustable button cinch anchor fasteners in
accordance with the present invention; the pawls of the collet are facing
away from the bone surface.
[0055] FIG. 36 is a cross section of the collet previously shown in FIG.
35 illustrating that the threads of the internal diameter only progress
halfway up the collet to allow for sliding of the collet on the shaft of
the anchor.
[0056] FIG. 37 is a fully deployed adjustable button cinch anchor fastener
in accordance with the present invention using the alternative
configuration of the collet previously shown in FIGS. 35 and 36; note
that the collet is required to be of a greater height in order to have
the prescribed number of threads contact the threaded surface of the
shaft.
[0057] FIG. 38 is an elevational view of an alternative shaft for an
embodiment of adjustable button cinch anchor fasteners in accordance with
the present invention having the first embodiment head (T1) and a fourth
embodiment tail (T4); the illustrated shaft is designed to be used with
suture.
[0058] FIG. 39 is an elevational view of a fully deployed H1-T4 embodiment
of the adjustable button cinch anchor fastener in accordance with the
present invention using the alternative configuration of the shaft
previously shown in FIG. 43; suture is used as the shaft.
[0059] FIG. 40 is a cross-sectional view of a deployed H1-T4 embodiment of
the adjustable button cinch anchor fastener in accordance with the
present invention using the alternative, suture, shaft previously shown
in FIG. 39.
[0060] FIG. 41 is a diagrammatic representation of an embodiment of an
adjustable button cinch anchor fastener in accordance with the present
invention having a third embodiment head (H3) and a fourth embodiment
tail (T4) in which the suture shaft of FIGS. 39 end 40 is used and in
which the upper end has been replaced with a rotating wing; the wing
being deployed using pull strings, the wing being illustrated relative to
and sitting in a cross section of bone.
[0061] FIG. 42 is an alternative configuration of the H3-T4 embodiment of
the adjustable button cinch anchor fastener in accordance with the
present invention; the alternative suture shaft of FIG. 40 being used
along with an upper end in the form of a rotating wing; the wing has been
deployed using the pull strings, the strings have been cut away, and the
fully deployed button cinch anchor and button is illustrated sitting in a
cross section of bone.
[0062] FIG. 43 is a diagrammatic representation of an alternative shaft
for an embodiment of an adjustable button cinch anchor fastener in
accordance with the present invention having the second embodiment head
(H2) and the first embodiment tail (T1); the shaft is planar as opposed
to round and has assumed an eye at its upper end for attaching soft
tissue.
[0063] FIG. 44 is a view of the H2-T1 embodiment of the adjustable button
cinch anchor fastener in accordance with the present invention in its
fully deployed position where the button is turned against the shaft of
FIG. 43 to provide variable tension on the tendon against the bone (shown
in cut-away view).
[0064] FIG. 45 is a front elevational view of a central plunger of a
central plunger, corresponding to the bone anchor, or a new embodiment of
the adjustable button cinch anchor fastener in accordance with the
present invention having any embodiment head (Hx) and an eighth
embodiment tail (T8).
[0065] FIG. 46 is a side elevational view of the central plunger of the
Hx-T8 embodiment of the adjustable button cinch anchor fastener in
accordance with the present invention previously seen in FIG. 45.
[0066] FIG. 47 is a cut-away view of a threaded nut into which the plunger
of FIGS. 45 and 46 fits.
[0067] FIG. 48 is a cut away view of the threaded nut with the plunger of
FIGS. 45 and 46 sitting in the pre-deployed position.
[0068] FIG. 49 is a cut away view of the threaded nut with the plunger of
FIGS. 45 and 46 sitting in the deployed position such that it will drive
a split shaft--such as in FIG. 53--outward towards the threaded internal
bore of a nut.
[0069] FIG. 50 is a bottom view of the nut and plunger of FIG. 49.
[0070] FIG. 51 is a top view of the nut and plunger of FIG. 49.
[0071] FIG. 52 is a side view of a threaded double ratchet strap of an
H2A-T8 embodiment of the adjustable button cinch anchor fastener in
accordance with the present invention.
[0072] FIG. 53 is a front view of the threaded double ratchet strap
previously seen in FIG. 52.
[0073] FIG. 54 is a front view of the threaded double ratchet strap in
which the nut has been slid up the double ratchet shaft and the plunger
is in the pre-deployed position.
[0074] FIG. 55 is a front view of the threaded double ratchet strap in
which the nut is in the deployed position with the plunger is pushed so
that it causes the straps to move outward and engage the nut threads so
that the nut can turn on the threaded strap; the excess strap has been
cut off.
[0075] FIG. 56 is a view of an H2A-T8A embodiment of the adjustable button
cinch anchor fastener in accordance with the present invention having an
alternative arrangement of the nut and plunger in which the plunger has
been configured so that it is attached by a flexible member to the nut.
[0076] FIG. 57 shows the plunger in the deployed position in the nut.
[0077] FIG. 58 is a view of an H2A-T6 embodiment of the adjustable button
cinch anchor fastener in accordance with the present invention having an
alternative configuration of the cinch in which it consists of a split
nut which is split so that the inside threaded hole can be expanded to
allow it to slide up a threaded shaft.
[0078] FIG. 59 shows the H2A-T6 embodiment of FIG. 58 in which the cut has
been opened in the pre-deployed position so that it can first slide up
the threaded shaft, then be closed so that mt contacts the threads of the
shaft, and then be rotated.
[0079] FIG. 60 is an alternative embodiment of the shaft and an H3
embodiment of the anchor in which the anchor is a rotatable member with a
living hinge; the shaft can take any type of nut, either the T1 or T6
embodiments.
[0080] FIG. 61 is the alternative embodiment of FIG. 60 in which the H3
anchor has been rotated within cancellous (spongy) bone to anchor into
the bone and the T6 split nut of FIG. 58 has been used to secure cinch
against the surface of the bone.
[0081] FIG. 62 is an alternative configuration of a cinch of FIG. 58 in
which the central hole has been replace with two holes to allow sutured
anchors, embodiment type T6A, to be utilized.
[0082] FIG. 63 is the nut of FIG. 62 in the open position which will allow
it to slide on the sutures.
[0083] FIG. 64 is the alternative embodiment T6A to the anchor in which a
suture has been put through the wing in a transverse fashion and the wing
is a rotatable member which rotates on the suture; the alternative
embodiment is shown being pushed through a bore through the bone with a
modified deployment sleeve (shown in cross-section).
[0084] FIG. 65 shows the alternative embodiment H4-T6A embodiment of FIG.
64 fully deployed in a cross section of bone in which the cinch is the
modified member of FIG. 62.
[0085] FIG. 66 shows in cross-section a shell used in a T1A variant of the
sliding split nut embodiment of the adjustable button cinch fastener.
[0086] FIG. 67 shows a cross section view of the split nut sitting in the
shell of FIG. 66 in the pre-deployed position.
[0087] FIG. 68 shows a cross section view of the split nut sitting in the
shell of FIG. 66 in which the nut has been pushed into the shell,
assuming a fully deployed position.
[0088] FIG. 69 shows an H4A alternative configuration of a threaded shaft
and a bore in its head which can receive a rotatable wing.
[0089] FIG. 70 shows a pin hinge of a T1/T1A-H4 alternative embodiment of
the adjustable button cinch anchor fastener.
[0090] FIG. 71 is the wing of the T1/T1A-H4 alternative embodiment of the
adjustable button cinch anchor fastener.
[0091] FIG. 72 shows the T1/T1A-H4 alternative embodiment of the
adjustable button cinch anchor fastener with the rotating wing of FIG. 71
and the shaft of FIG. 69 in which the upper end has a rotating wing which
has been attached to a pin-hinge configuration; a fractured bone is being
shown in cross section, and the threaded shaft with a pre-deployed wing
engages the split cinch nut of FIG. 67 in the pre-deployed position.
[0092] FIG. 73 shows the T1/T1A-H4 alternative configuration of the
adjustable button cinch anchor fastener with the rotating wing of FIG. 71
and the shaft of FIG. 69 in which the upper end of the shaft engages a
rotating wing which has been attached to a pin-hinge configuration; a
fractured bone is shown in cross section, and the threaded shaft with the
deployed wing engages the split cinch nut of FIG. 67 in its deployed
position.
[0093] FIG. 74 is an H4A alternative configuration of the adjustable
button cinch anchor fastener with the rotating wing of FIG. 71 and the
shaft of FIG. 69 in which the upper end of the shaft engages a rotating
wing which has been attached to a pin-hinge configuration; a fractured
bone is shown in cross section with the threaded shaft and deployed wing
engaging the split cinch nut of FIG. 67 in the deployed position while
the excess shaft and the excess shell of the nut have both been cut off.
[0094] FIG. 75 shows an alternative T1B configuration of the split nut
button of FIG. 67 in which the threads and split have been set internal
to the shell and the shell has a special rim to hold the split nut inside
once the nut has been put in the deployed position; the nut can rotate in
compression or tension following deployment.
[0095] FIG. 76 shows a cross sectional view of a new embodiment T6 tail: a
ratchet mechanism for a double shaft ratchet.
[0096] FIG. 77 shows an aerial view of the button with the T6 internal
ratchets.
[0097] FIG. 78 shows a T6 ratchet strap whose ratchets will articulate
with the tabs of FIG. 76 to allow compression and tension on the tissues;
a strap is shown in metal along with H5 and H5B alternative embodiments
of the wings being spring metal which are compressed in order to fit into
the bore in the bone; upon attaining the proper depth, the wings are
allowed to spring outward and anchor in the bone.
[0098] FIG. 79 shows a T6 ratchet strap whose ratchets will articulate
with the tabs of FIG. 76 to place a selectable tension on the secured
tissues; the strap is shown in plastic along with the H5B alternative
embodiment of the wings made from the same piece of plastic as the anchor
body; the wings are compressed in order to fit into the bore in the bone
and upon attaining the proper depth, the wings are allowed to spring
outward and anchor in the bone.
[0099] FIG. 80 shows the T6 ratchet strap and button of FIG. 78 with an
alternative embodiment H7 of the bone anchor; the H7 embodiment
consisting of a threaded upper shaft; following threading this anchor
into bone, the ratchet is slid up the shaft and the excess threads are
cut off.
[0100] FIG. 81 shows an H7 embodiment of the bone anchor in which the
anchor has been replaced by a compressive slotted umbrella; the ratchet
strap mechanism has been revised as well to an embodiment type T6A and is
now spring material that is compressed into the cinch (shown in FIG. 82)
and the cinch can slide up the ratchet shaft only one way.
[0101] FIG. 82 shows an alternative configuration of the cinch button
which will slide one-way on the T6A cinch shaft.
[0102] FIG. 83 shows a top plan view of another configuration, called T6B,
of the cinch button in which the central piece is ovoid and rotates
against the two ratchet members to push them into the walls of the
threaded nut; in this case the ratchets can be similar to those of FIG.
78.
[0103] FIG. 84 shows a cutaway side view of the T6B cinch button of FIG.
83; note the place for a screw driver to turn the inner button.
[0104] FIG. 85 shows an H9-T6A/T6B embodiment anchor of FIG. 81 plus an
alternative anchor method in which a ball on a string is used to spread
the split anchor shaft.
DETAILED DESCRIPTION OF THE INVENTION
[0105] The easy-to-use two-ended fastener device of the present invention
represents an improvement upon other related devices disclosed in prior
patent applications of the same inventor Yosef Freedland.
[0106] The first application was filed Mar. 23, 1992, as Ser. No.
08/034,269 and the second was filed on Jan. 21, 1994 as Ser. No.
08/184,121. The first of the two applications deals with bone anchoring
devices which are distinguished in that "wings extend beyond the
[deployment] sleeve". While the present invention also incorporates this
deployment method and is a Continuation-in-Part of the 1993 patent
filing, the anchoring end has been modified so that it can work in
conjunction with a sliding button cinch arrangement.
[0107] The latter of the two related applications, Ser. No. 08/184,121,
deals with a sliding button cinch device at the opposite end of a shaft
to which an anchoring device has been secured such that the button can
provide an adjustable compressive force on a bone or tendon surface. The
button cinch was configured in a manner in which tabs on the button
would, through a ratchet action, slide up a ratchet shaft to be held in
position. The button cinch was unique both in configuration and in
providing a new concept in tissue fixation, namely the provision of
adjustable and measurable tension or compression on tissues following
implantation of a fastening device. This concept is carried forward in
the present invention.
[0108] Such a characteristic of adjustable tension or compression in the
joining of tissues is exceptionally important. The medical field is now
recognizing that the healing of fractured or torn tissue proceeds under
specific amounts of many factors including change in electrical potential
of the bone, distribution of chemo-tactic materials and specific amounts
of tension or compression which cause the tissue to heal and reorganize
the reparative cells with specific architecture to support and join the
fractured or broken parts such that the specific forces which come
together at the site of the injury are neutralized.
[0109] By providing specific tension or compression levels at the site
where repair must take place, it is presumed that the healing will take
place faster and that the architecture of the repair will be manufactured
by the body in an optimal fashion which will more closely resemble the
final configuration of those tissues following complete healing and
removal or dissolution of the fastener device hardware.
[0110] Another class of orthopedic fasteners are made of plastic and thus
have the advantage of being radiolucent so that the post-operative
radiograph shows a clear, unobstructed suture site. This should be
contrasted with metal anchors that block the complete field direction
behind the anchor. Again, this class of anchor uses suture to attach the
tissue to it. These plastic anchors rely on partial shear and compression
forces to achieve fixation in soft bone, and are thus less resistant to
being moved or dislodged than would a fastener that was forced,
especially compressively forced, against hard bone.
[0111] Still another class of orthopedic fasteners relates to those which
can dissolve following a specific period of time in the tissue. There are
a variety of materials which can be used to achieve this dissolvability
of which, at the present time, polyglycolic acid (PGA) which is a common
suture material, is the material often utilized. Anchors which dissolve
over time are characterized by the experimental Lactosorb under
investigation by U.S. Surgical, and by the dissolvable TAG sold by
Acufex. As noted, these devices, are put into the bone under compression
and are abraded by the surrounding bone as they are put into place and
expanded. This process develops microscopic debris. This debris has a
tendency both to cause (i) premature immune cell response, and (ii)
micro-fissures in the implant causing joint damage and susceptibility to
early break-up. In the case of the Acufex TAG, the device is formed as a
simple ridged barrel with a suture attached. The barrel is pushed into
the bore in the bone and the rigid rings prevent back out of the implant.
[0112] The anchoring portion of the adjustable button cinch anchor
fastener in accordance with the present invention will be seen to be
similar to the Mitek anchor in that it achieves its anchoring through
expansion of fins or flukes into bone adjacent to the bore drilled in the
bone. However, it significantly differs in that the flukes are in a
collapsed state during the insertion and are not held in this state by
the pressure of the walls of the bore. When and only when the adjustable
button cinch anchor fastener achieves its proper position, the shaft is
pulled upon to cause the flukes to spread radially outward into the
adjacent bone through a cam action of the shaft on the flukes. This is a
superior method of deployment as the scraping and scratching of the
anchor surface is avoided, preventing the immediate release of
microscopic debris in the adjacent tissue, leading to early tissue
reaction to the implant. Moreover, the direction of the spreading will be
see to be so as to present a greater diameter of the anchor in the
direction of the opening of the bore in which the anchor is lodged, and
towards the hard bone at the surface opening of the bore. This means that
the anchor maintains its position in bone not only in compression, but
also in compression against hard, as opposed to soft, bone.
[0113] The securing end of the adjustable button cinch anchor fastener of
the present invention will also be seen to differ from the Mitek anchor
in that it does not rely on the threading of the soft tissue onto the
suture and knotting to hold it down. Rather, it has a compression button
such that the soft tissue is held against the bone with a compressive
force spread over the surface area of the compression button. This offers
significant advantage over suture knots in that the point pressure of
thin threads is absent, allowing a more stable fastening of the soft
tissue.
[0114] Yet another group of fasteners are the winged bolts in which the
device is wholly removable following use. Some of these devices are
disclosed in U.S. Pat. No. 4,409,974 for a BONE-FIXATING SURGICAL IMPLANT
DEVICE to the selfsame inventor of the present application under his
former name of Jeffrey A. Freedland, and also under U.S. Pat. No.
5,098,433 under the same inventor's present name, Yosef Freedland.
[0115] The fastener of the present invention will be seen to differ from
these previous devices for, inter alia, having fewer moving parts here.
The design of the fastener of the present invention will be seen to lend
itself to manufacture from plastic and dissolvable materials. In the
first place it has and presents a greater bulk that is useful for
fabrication with these materials. In the second place, it does not
require a great deflection or other forcible distortion of moveable
portions or pieces to achieve an anchoring effect, thus permitting the
use of plastics that are slightly brittle. Several layers of operating
mechanisms would be very large compared to metal devices. Further, the
opposite end of the anchor, to which the second tissue was attached,
either consisted of a knotting of suture, or a threaded nut arrangement.
In the case of the Orthopedic Fastener, the compression button can be
pushed into placed and secured without turning it on a threaded shaft.
[0116] Further, in its preferred embodiment, the Adjustable Cinch allows
tension to be adjusted following implantation which is unique in the
anchor market. This is particularly useful in multiple fractures where
several pieces of bone must be aligned in order to get an appropriate
result. As the pieces are put into place, previously placed fixation
devices can be re-adjusted in tension level to permit the pieces to fit
better.
[0117] The adjustable button cinch anchor fastener of the present
invention will be seen to have the shaft that can easily be manufactured
from a material such as plastic which can be cut to any length following
implantation. This allows it to be a one-size-fits-all implant while
maintaining the unique ability to be adjustable in its compressive or
tension force following implantation. Indeed increasing tension or
compression can be made even following cutting the excess shaft.
[0118] In yet another embodiment of the adjustable button cinch anchor
fastener of the present invention, the bone anchor will be seen not to
use a wing. In this case, the shaft has only a compression button at one
end and a direct receptacle for soft tissue in the shaft on which the
compression button sits. This type of shaft offering an adjustable
compression method is noted in my patent which was filed Jan. 21, 1994
under Ser. No. 08/184,121. This previous application teaches to the
general concept of a fastener device which applies adjustable tension or
compression on a tissue following implantation of the device. However,
the device taught within the predecessor application relies on a simple
threaded nut arrangement to provide this adjustable force. This
arrangement is sub-optimal because it takes a long time for the surgeon
to install, perhaps as much as four minutes longer than an adjustable
button cinch anchor fastener in accordance with the present invention.
[0119] The present invention is embodied in orthopedic fixation devices
for bringing one object close to another by applying a selectively
adjustable compressive force on a surface or surfaces of tissue or,
equivalently, a selectively adjustable tension force tending to draw two
tissues closer together.
[0120] 1. Operation of Adjustable Button Cinch Anchor Fastener in
Accordance With the Present Invention
[0121] The present invention contemplates fast and efficient, variable
tension, strong and reliable robust fastening of a soft tissue to a hard
tissue, such as tendon to bone, by fastener devices that are well
tolerated by, and highly effective to, engage both tissues connected, and
that are additionally bio-absorbable in some variants.
[0122] The preferred fastener devices so function by incorporating
separate and severable, novel, features at both ends. A one end of the
fastener device is mounted down-hole a bore in hard tissue (bone). This
fastener end includes an expandable (first) collet having bendable
circumferential flukes sliding upon an end region of a central shaft. The
end region of the shaft, and the (first) collet, are inserted in bore
while the collet is un-expanded. The collet is then expanded by forcibly
pulling along the shaft so as to force its bendable circumferential
flukes against a ramp surface present on the shaft. This causes the
bendable flukes to thereafter permanently (regardless of shaft position,
which is nonetheless normally left wedged) slay outward, and radially
extend from the central shaft.
[0123] The extended flukes (i) strongly compressively press into softer
interior regions of bone while (ii) providing an enhanced diameter insert
that has a pull force against the hard exterior surface of the bone that
is so great that most bones will break before the bore fastener will
dislodge. Installation of the fastener in the bore is quick, easy and
sure. Nonetheless to being strong, the down-hole splayed end of the
fastener may be entirely implemented of bio-absorbable plastic or
artificial bone (collagen) as is typically particularly presently
characterized for having only (i) modest physical strength and (ii)
inferior flexibility. This is because (i) all down-hole sections of the
fastener are robustly sized, and (ii) its flukes bend only but slightly,
and in the correct direction to prevent pullout.
[0124] Meanwhile, the other end region of the fastener exterior to the
bore is characterized by a combination sliding and turning (screwing)
action that is suitable to both (i) engage a large area of the soft
tissue (tendon), and to (ii) draw it toward the hard tissue (bone).
Basically, a "button anchor" engaging the soft tissue (the ligament)
(including by novel means) and having an expandable, and already
expanded, internally-threaded (second) collet is slid onto an
externally-threaded shaft mounted in hard tissue. At proper extension
this (second) collet is compressed by an external ring--inserted by use
of a simple tool in the form of a tubular sleeve--that causes permanent
engagement of the interior threads of (second) collet with the exterior
threads of the shaft. The threaded (second) collet may thereafter be
screwed upon the shaft in fine adjustment, and re-adjustment, of
fastening tension, and the shaft may be trimmed in length, producing a
small "button anchor".
[0125] The sliding motion, in particular, is characterized by being
efficient, and readily accomplishable to good effect generally in shorter
time than previous techniques. The screw motion, in particular, is
characterized for providing a variably selectable, adjustable and
re-adjustable tension force. Insofar as such tension is important to
promote the compressive healing of soft tissue (tendon) to hard tissue
(bone)--which importance is just being recognized at the time of the
filing of the present patent application--the preferred fastener of the
present invention both provides this tension, and provides it an
adjustable optimum level.
[0126] As with the compressive anchor internal to the hard tissue (the
bone), the button anchor securing the soft tissue (the tendon) is again
physically substantial and robust in all sections, and thus suitable for
at least partial implementation in certain bio-absorbable plastics and in
collagen (artificial bone) that, nonetheless to being well tolerated by
and absorbable within the body, are not so physically strong as are, for
example, metals. The entire fastener is characterized by suitable
incorporation of (i) bio-absorbable materials wheresoever fastener parts
are potentially loosed by process of healing or normal changes in the
body, (ii) conventional materials of long-term biological stability in
other parts elsewhere located (such as the fastener shaft which is
conventionally made of plastic) or (iii) combinations of (i) and (ii). In
general the entire fastener is intended to be well tolerated by the body
both during healing and thereafter, and to be extremely unlikely of ever
leaving any parts or pieces that become subject to either undesirable
migration or reaction within the joints or the body as a whole.
[0127] Note that, in construction and in operation of the preferred
embodiment of the fastener, a first expandable collet located down-hole a
bore in the hard tissue (the bone) is inserted (upon and along a shaft)
while un-expanded and is later expanded whereas a second expandable
collet located outside the hard tissue (the bone) and used to secure the
soft tissue (the tendon) is slid upon and along the shaft while expanded
and is later, when threadingly engaging the shaft for screwing,
contracted. One advantage, in accordance with the present invention of an
expandable collet that slides into position at a first time, and that
subsequently locks into position at a later, second, time, is that such a
collet installs very quickly, easily and accurately.
[0128] 2. Embodiments of Adjustable Button Cinch Anchor Fastener in
Accordance With the Present Invention
[0129] In one of its preferred embodiments, the Adjustable Button Cinch
anchor fastener of the present invention a shaft which ends in an
expanding member which is attached to a tissue such as bone. The other
end of the shaft has a securing button which is in close proximity to a
second tissue, often consisting of soft tissue such as tendon. In the
preferred embodiment, the securing button can move up or down the shaft
while it is secured against the tissue in vivo, so that tension or
compression can be adjusted on the secured tissues. Once the securing
button has been adjusted on the shaft to a given length, a hoop is pushed
onto the threaded collet portion of the button so that the collet
contacts the shaft and holds the button in place. Following this, the
threads on the collet and the shaft allow the securing button to be
rotated as a common threaded nut on a screw so that the compression or
tension between the tissues can be adjusted. The excess shaft which
extends from the nut, can be cut.
[0130] 3. Method of Using an Adjustable Button Cinch Anchor Fastener in
Accordance With the Present Invention
[0131] In another of its aspects, the present invention can be considered
to be expressed in a method of variably selectively compressing, or
tensioning, a soft tissue in vivo to another, second, tissue.
[0132] A free end of the soft tissue is engaged in vivo (i) about an
elongate fastener that is affixed at a one end thereof down-hole a bore
present within another, second tissue, the elongate fastener having and
presenting when so affixed an extension region that extends beyond the
bore, and (ii) between, on the one hand, a sliding lock that both slides
along the fastener region that extends beyond the bore, and that locks
and unlocks in its position upon the fastener's extension region, and, on
the other hand, the second tissue.
[0133] The sliding lock is slid to a selectable first position along the
fastener region that extends beyond the bore so as to compress, or to
tension, the soft tissue to a first variably selectable extent in its
position engaged about the fastener's extension region (i.e., between the
sliding lock means and the second tissue, into position relative the
first tissue).
[0134] The sliding lock is then locked in its selectable first position,
therein to compress, or to tension, the soft tissue against, or
proximately to, the second tissue to a variably selectable first degree
(or extent).
[0135] Notably in accordance with the present invention, this method may
be expanded and extended to include variably selectively re-compressing
in vivo the free end of the soft tissue. Such an expanded and extended
includes unlocking in vivo--necessarily at a time after the locking--the
locked sliding lock in its first selectable position along the fastener
region. The sliding lock is then slid in vivo along the fastener region
that extends beyond the bore to a selectable second position. It therein
serves to compress (or tension) the soft tissue that has been engaged
about the fastener's extension region into position against the first
tissue to a second variably selectable degree (or extent). This second
degree (or extent) is normally different from the first variably
selectable degree (or extent). The sliding lock is then re-locked at it's
selectable second position, therein serving to re-compress (or to
re-tension) the soft tissue against (or proximately to) the second tissue
to the variably selectable second degree (or extent).
[0136] The in vivo engagement preferably involves forming an aperture in
the free end of the soft tissue, and the slipping this aperture over an
end of the elongate fastener opposite to that end of the fastener that is
affixed down-hole the bore.
[0137] The engaged and compressed (or tensioned) soft tissue may typically
be any of a tendon, a ligament, or a joint capsule. The elongate fastener
is typically affixed at a one end thereof down-hole a bore that is
present within bone.
[0138] 4. Advantages of Adjustable Button Cinch Anchor Fastener and Method
of Use, in Accordance With the Present Invention
[0139] It has been discovered according to the present invention that a
button cinch anchor fastener can be used to provide variably selectable
tension or compression to tissues over a predetermined tissue surface.
[0140] It has further been discovered according to the present invention
that (i) a compression button can be used in conjunction with a shaft of
the fastener so that tissues can be attached to the shaft while the
compression button is attached to another tissue, and that (ii) the
compression button can be moved, and re-moved, on the shaft in vivo so
that the tissues can be brought under selectable tension or compression
in relation to each other. A bore can be placed through the soft
tissue(s) to be fixated so that this tissue can be attached directly
about and to the fastener.
[0141] It has still further been discovered according to the present
invention that a button of a button cinch anchor fastener can be used in
conjunction with a shaft of the fastener to which shaft a spreading
anchor device has been attached so that the anchor device formed thereby
can secure both the shaft and compression button into hard tissue such as
bone.
[0142] It has still further been discovered according to the present
invention that a fastener can be manufactured in material which can be
cut following implantation so that the fastener can be manufactured in a
single length and later adjusted in vivo and during the implantation
procedure to the proper size.
[0143] It has still further been discovered according to the present
invention that the by putting threads on the compression button and on
the shaft of a button cinch anchor fastener, the threads on the shaft can
interface with threads on the compression button, permitting the button
to be turned on the threaded shaft at a time after it has been pushed, or
slid, into position on the shaft--thereby selectively increasing or
decreasing tension or compression between the two tissues in vivo.
[0144] Finally, it has discovered that a button cinch anchor fastener in
accordance with the present invention may be constructed substantially,
or entirely, from material(s) that are bio-absorbable.
[0145] According to these discoveries, collectively, a fast and efficient,
variable tension (compression), strong and reliable, robust system for
the fastening of a soft tissue--such as a tendon, or ligament, or joint
capsule--to a hard tissue--such as a bone--is presented.
[0146] Although specific embodiments of the invention will now be
described with reference to the drawings, it should be understood that
such embodiments are by way of example only and merely illustrative of
but a small number of the many possible specific embodiments which can
represent applications of the principles of the invention. Various
changes and modifications obvious to one skilled in the art to which the
invention pertains are deemed to be within the spirit, scope and
contemplation of the invention as further defined in the appended claims.
[0147] The present invention presents an easy, reliable, one-size-fits-all
fixation method which results in less instrumentation and fewer steps to
install. Further, it allows the adjustment of the tension or compression
on the tissue in which the device is fastening in vivo.
[0148] FIGS. 1-31 are all show a primary embodiment of an adjustable
button cinch anchor orthopedic fastener 1 of the present invention with
(i) a first, H1, embodiment "Head", or anchor, 11 consisting of a shaft
111 with a first embodiment expandable collar 112, and (ii) a first
embodiment "Tail" consisting of a first embodiment collet 12, a first
embodiment spiked washer 13, and a first embodiment hoop 14. The present
invention will be characterized by having many embodiments of both the
Head (H) and the Tail (T) sections of the fastener. However, all
embodiments and variants exhibit certain functionality in common, and
this should be maintained in mind as the various different embodiments,
and the various variants of the different embodiments, are explained.
[0149] An elevational view of the threaded shaft 111 of the anchor 11 of
this H1-T1 embodiment of an adjustable button cinch anchor orthopedic
fastener 1 is shown in FIG. 1. A front elevational view of a collet 12
which surrounds the threaded shaft 111 (previously seen in FIG. 1) of the
T1-H1 embodiment of the adjustable button cinch anchor fastener 1 is
shown in FIG. 2, while a cut-away view of this collet 12 is shown in FIG.
3.
[0150] An elevational view of a spiked washer 13 of the Ti-Hi embodiment
of the adjustable button cinch anchor fastener 1 is shown in FIG. 4. The
spiked washer 13 helps to secure the anchored soft tissue 4 (not shown in
FIG. 4, shown in FIGS. 23-71).
[0151] An elevational view of a hoop 14 which encircles the collet 12 to
push the internal threads 121 of the collet 12 into the threads 1111 of
the shaft 111 of the anchor 11 in the T1-H1 embodiment of the adjustable
button cinch anchor fastener 1 is shown in FIG. 5. A cut-away view of the
same hoop 14 is shown in FIG. 6. A cut-away view of the same hoop 14
positioned around the collet 12, the hoop 14 being located in the
pre-deployed position, is shown in cut-away view in FIG. 7. The collet 12
preferably has an external circumferential phalange 123 that mates with a
complimentary circumferential groove 141 on the interior of the hoop 14
to hold the hoop 14 in a fill surround, locked, position upon the collet
12--as is particularly illustrated in FIG. 8.
[0152] A cut away view of the H1-T1 embodiment of the adjustable button
cinch anchor fastener 1 in which the hoop 14 has been advanced up the
collet 12 to compress the collet pawls 122 radially inward is shown in
FIG. 8. A cut-away view of the same H1-T1 embodiment of the adjustable
button cinch anchor fastener 1 in which the excess collet 12 below the
hoop 14 has been cut off and is being removed is shown in FIG. 9.
[0153] Continuing in FIGS. 10, et seq., an expandable collar 112 interacts
with the shaft 111 in, and so as to jointly form, the anchor 11 of the
fastener 1. An elevational view of the T1-H1 embodiment of the adjustable
button cinch anchor fastener 1 in accordance with the present invention,
now in its pre-deployed position with the flukes 1121 of its expandable
collar 112 in place, is shown in FIG. 10.
[0154] Yet another elevational view of the T1-H1 embodiment of the
adjustable button cinch anchor fastener 1, now in its deployed position
with the expandable collar 112 pushed upward to contact the upper table
1111 of the shaft 111, forcing the flukes 1121 into a splayed and
deployed position, is shown in FIGS. 11 and 12. A cut-away view of this
T1-H1 embodiment of the adjustable button cinch anchor fastener 1 in its
deployed position (as was previously seen in FIG. 12) is shown in FIG.
13. Note that the flukes 1121 of the expandable collar 112 of the anchor
11 of the adjustable button cinch anchor fastener 1 are oriented
(downwards in FIGS. 10-13) so as to jam against the hard exterior shell
of bone 3 in their deployed positions. The deployed anchor 11 is normally
impossible to extract by simple pulling without shattering the bone 3 in
which it is mounted.
[0155] An elevational view of the flukes 1121 of the expandable collar 112
of the anchor 11 of the T1-H1 embodiment of the adjustable button cinch
anchor fastener 1 in their pre-deployed positions is shown in FIG. 14. A
cross sectional view of these flukes 1121 taken along lines "A-A" of FIG.
14 is shown in FIG. 15; a cross-sectional view of the flukes 1121 taken
along lines "B-B" of FIG. 14 is shown in FIG. 16.
[0156] An elevational view of the flukes 1121 of the expandable collar 112
of the anchor 11 of the T1-H1 embodiment of the adjustable button cinch
anchor fastener 1 in their deployed positions is shown in FIG. 17. A
cross-sectional view of the flukes 1121 taken along lines "C-C" of FIG.
17 is shown in FIG. 18. A cross sectional view of the flukes 1121 taken
along lines "D-D" of FIG. 17 is shown in FIG. 19.
[0157] An elevational view of the T1-H1 embodiment of the adjustable
button cinch anchor fastener 1 of the present invention showing the
flukes 1121 of the expandable collar 112, and also the shaft 110--both
parts of the anchor 11--in their deployed positions at a time following a
forced deployment of the flukes 1121 by an accessory deployment sleeve 2
(not part of the fastener 1) is shown in FIG. 20. The bone
anchor--consisting of the shaft 111 and the expandable collar 112 with
its flukes 1121--is in process of being inserted into the bone 3 (clearly
not a part of the fastener 1), which bone 3 is shown in cut-away view.
Yet another elevational view of the T1-H1 embodiment of the adjustable
button cinch anchor fastener 1 of the present invention is shown in FIG.
21. The flukes 1121 (of the expandable collar 112) and the shaft 111 of
the anchor 11 are shown in their deployed positions holding a piece of
soft tissue 4, with the spiked washer 13 being aligned on the shaft 111.
The elevational view is shown relative to a cross section of the surface
of a bone 3.
[0158] Still yet another elevational view of the T1-H1 embodiment of the
adjustable button cinch anchor fastener 1 of the present invention is
shown in FIG. 22. The expandable collar 112 with its flukes 1121, and the
shaft 111, of the anchor 11 are in their deployed positions holding a
piece of soft tissue 4, and the spiked washer 13 (previously seen in
FIGS. 4 and 21, and now shown in cross-section) is being placed upon the
shaft 111. This elevational view is again shown relative to a cross
section of the bone 3.
[0159] Still yet another elevational view of the T1-H1 embodiment of the
adjustable button cinch anchor fastener 1 of the present invention is
shown in FIG. 23. The expandable 112 with its flukes 1121, and the shaft
111, of the anchor 11 are in their deployed positions holding a piece of
soft tissue 4. The spiked washer 13 (previously seen in FIG. 21, again
shown in cross section) is being aligned near a surface of the bone 3
(shown in cross section). The collet 12 and the hoop 14 of the adjustable
button cinch anchor fastener 11 are shown being put into position on the
fastener's shaft 111 so that the inner threads 121 of the collet 12 are
adjacent to the outer threads 1111 on the shaft 111 of the anchor 11. The
hoop 14 has not yet been snapped into its deployed position.
[0160] Still yet another elevational view of the T1-H1 embodiment of the
adjustable button cinch anchor fastener 1 of the present invention is
shown in FIG. 24. The flukes 1121 and the shaft 111 are in their deployed
positions holding a piece of soft tissue 4 (shown in cross section). The
spiked washer 13 is also in position about the collet 12. The hoop 14 has
been moved up the shaft 111 of the anchor 11 and over the collet 12 so
that it is nearly snapped into its final position.
[0161] A cross sectional view of the collet 12, the spiked washer 13 and
the hoop 14 within the T1-H1 embodiment of the adjustable button cinch
anchor fastener 1 is shown in FIG. 25. Soft tissue 4 in the form of a
tendon, and the fastener's shaft 111, are also shown in elevational view.
[0162] Still yet another elevational view of the T1-H1 embodiment of the
adjustable button cinch anchor fastener 1 of the present invention is
shown in FIG. 26. The expandable collar 112 with its flukes 1121, and the
shaft 111, of the anchor 11 are in their deployed positions. The spiked
washer 13 is now being held in position by the hoop 14 snapped into place
on the collet 12 so that pawls 122 of the collet 12 have been compressed
into the threads 1111 of the shaft 111, thereby to hold a piece of soft
tissue 4.
[0163] A cross-sectional view of the collet 12 and the hoop 14 previously
seen in FIG. 26, along with an elevational view of the (bone) anchor 11
including the shaft 111, is shown in FIG. 27. The view is relative to a
cross section of the bone 3.
[0164] Still yet another elevational view of the T1-H1 embodiment of the
adjustable button cinch anchor fastener 1 of the present invention is
shown in FIG. 28. The (bone) anchor 11 with its expandable 112 with its
flukes 1121 is in the deployed position. The soft tissue 4 is further
held in position by the spiked washer 13. This spiked washer 13 is
compressed by the fastener's collet 12 which is in turn compressed by the
fastener's hoop 14. The excess collet 12 has been cut away from the pawls
122 (best shown in FIG. 3) of the collet 12, which pawls 122 are
compressed under the hoop 14.
[0165] A cutaway breakaway view of the spiked washer 13, the hoop 14 and
the collet 12 is shown in FIG. 29. An elevational view of the shaft 111
of the button anchor 11 is also shown. Note the excess collet 12
(partial), which is shown in cutaway breakaway view.
[0166] Still yet another elevational view of the T1-H1 embodiment of the
adjustable button cinch anchor fastener 1 of the present invention is
shown in FIG. 30. The flukes 1121 and the shaft 111 are in their deployed
positions. An elevational view of the hoop 14 and the collet 12 in their
deployed positions is also shown. The excess of the shaft 111 (partial)
of the anchor 11 of the fastener 1 has been cut off. The collet 12 is
able to rotate in order to be screwed upon the shaft 111, thereby to
apply varying amounts of pressure to the held soft tissue (e.g., a
tendon) 4.
[0167] A cross sectional view of the T1-H1 embodiment of the adjustable
button cinch anchor fastener 1 of the present invention is shown in FIG.
31. The flukes 1121 and the shaft 111 are in their deployed positions. A
piece of soft tissue 4 is shown aligned and held near the a surface of
the bone 3 (which bone surface is shown in cross-section).
[0168] A variant of the head section, but a whole new embodiment of the
tail section--embodiment T2--of a fastener 1A in accordance with the
present invention is shown in FIGS. 32 and 33. The embodiment of the head
section is but a variant because the threaded shaft 111 (shown in FIG. 1)
has been replaced with a shaft 111A (of an anchor 11A) having a friction
surface as shown in FIG. 32. The tail section is, however, a completely
new embodiment because the collet 12A has been significantly changed so
that it now has radial phalanges, or interior circumferential grooves,
121A (instead of threads 121, shown in FIG. 4) that unite with the
friction surface on the surface of the shaft 111A of the anchor 11A. The
expandable anchor 112 and the hoop 14 remain the same as in the first,
H1-T1, embodiment of the fastener 1 (shown in FIGS. 1-31).
[0169] An elevational view of a new embodiment shaft 1 IA having a
friction surface shaft 111A in this H1-T2 embodiment of the adjustable
button cinch anchor fastener 1A of the present invention is shown in FIG.
32. A cross section of the collet 12A having parallel ribs 121A which
contact the friction surface of the shaft 111A in this H1-T2 embodiment
of the adjustable button cinch anchor fastener 1A is depicted in FIG. 33.
(The hoop 14 is also shown in cross-section in FIG. 33.)
[0170] FIGS. 35-37 show yet another new--H1-T3--embodiment of a fastener
1B. This H1-T3 embodiment of the fastener 1B is distinguished by having a
tail section that is new because the no outside hoop 14 (shown in various
of FIGS. 7-34) is employed, and instead a new, springy, type of collet
12B is used (along with the original threaded shaft 111).
[0171] A view, and a cut-away view, of the new collet 12B of this H1-T3
embodiment of the adjustable button cinch anchor fastener 1B are
respectively shown in FIGS. 35 and 36. The cut-away view of FIG. 36 in
particular illustrates that the threads 12B1 of the new collet 12B only
progress halfway up the collet 12B, thereby to permit and facilitate
sliding the collet 12B onto the shaft 111 of the anchor 11.
[0172] This old shaft 111--which was previously depicted in various of
FIGS. 1-31--and this new collet 12B are shown deployed in FIG. 37. The T3
embodiment of the collet 12B previously shown in FIGS. 35 and 36 is
clearly used. Note that the collet 12B is required to be of a greater
height in order to have the prescribed number of its threads 12B1 contact
the threaded surface 1111 of the shaft 111. The excess shaft 111 may be
cut off. Note that the pawls 12A2 of the collet 12A are facing away from
the bone surface. (The flukes 1121 of the expandable collar 112 buried
within and engaging the bone 3 continue to face oppositely, and towards
the surface of the bone 3.)
[0173] FIGS. 38-40 show still yet another new embodiment--embodiment
H1-T4--of a fastener 1C. The embodiment is new because the previous
collet 12 (shown, for example, in various of FIGS. 1-42) has been
modified into yet another embodiment collet 12C, now so as to hold onto
suture 111C1 (shown in FIGS. 39 and 40). This embodiment of the fastener
1C is probably the least desirable of all configurations, and is shown
primarily for sake of completeness.
[0174] An elevational view of part of the alternative collet 12C for this
H1-T4 embodiment of adjustable button cinch anchor fastener 1C in
accordance with the present invention is shown in FIG. 38. The
illustrated collet 12C is designed to be used with suture 11C1. The
collet 12C is split longitudinally, and engages (typically) two strands,
or lines, of suture.
[0175] Continuing in FIGS. 39 and 40, the shaft 11 IC is barely
recognizable as such. The shaft 111C is modified from the original shaft
111 (shown in FIG. 1) by being truncated, and by having a (typically
transverse) aperture emplaced though it, through which aperture is passed
suture 111C1. Because the suture 111C1 itself can be considered to be an
extension of the shaft 111C, both elements commence with identification
"111C".
[0176] An elevational view of this fully deployed H1-T4 embodiment of the
adjustable button cinch anchor fastener 1C in accordance with the present
invention (using the alternative configuration of the shaft 111C
previously shown in FIG. 43) is shown in FIG. 39.
[0177] A cross-sectional view of a deployed H1-T4 embodiment of the
adjustable button cinch anchor fastener 1C in accordance with the present
invention (using the alternative shaft 111C incorporating the suture
111C1 (both previously shown in FIG. 39), and the suture-engaging collet
12C (shown in FIGS. 38 and 39) is shown in FIG. 40.
[0178] FIGS. 41 and 42 show still yet another new embodiment--embodiment
H3-T4--of a fastener 1D in accordance with the present invention. The
embodiment has a new head (H) because the anchor 11D has been modified in
the element of its shaft 111D as a swiveling "wing" 11D1 and a suture
"shaft" 111D1. This head (H1 embodiment prevents that the anchor 11D
should pass through a bore from one side of a tissue (i.e., bone) to
another. The tail (T) remains the same embodiment (i.e., T4) as in FIGS.
38-40.
[0179] An detail elevational view of this alternative fastener 1D having a
shaft 111D consisting of suture (for the H1-T4 embodiment of adjustable
button cinch anchor fastener in accordance with the present invention) is
shown in FIGS. 42 and 43. The illustrated suture shaft 11D is designed to
engage the suture-engaging collet 12C previously shown in FIGS. 38-40.
[0180] The embodiment of the anchor, or head, 11D shown in FIGS. 41 and 42
is new because it is in the shape of a bar, or "wing", 11D1 with two
holes in it for suture 111D, and it rotates on this suture 111D. The tail
remains the embodiment based on the suture-engaging collet 12C, and the
conventional hoop 14, previously seen in FIGS. 38-40. The combined
embodiment is especially useful if the surrounding tissue is very thin
and devoid of muscle and/or fat, such as on the forehead or the front of
the shin.
[0181] This T1H3 embodiment fastener 1D of FIGS. 41 and 42 is new because
the anchor 11D in the form of a wing 11D1 has two holes in it for the
suture 111D, and rotates on the suture. The wing 11D1 is pulled into
position by the two temporary threads 5 looped through each end, as is
shown in FIG. 41. The installation of this is typically where the
placement threads 5 are attached to a long straight needle. The needle is
passed through the hole in the bone and then pushed through the soft
tissue around the bone until the needle comes through the surface of the
skin. The surgeon then removes the needle and effectively has a
marionette on strings to work with. The surgeon pulls on the marionette
strings until the "wing" 11D1 of the anchor, or head, 11D is passed
through the bone, and he or she then uses them to rotate the "wing" 11D1.
[0182] FIG. 42 shows the "wing" 11D1 of the head, or anchor, 11D in its
transverse position located across the bone 3. The marionette strings, or
threads, 5 have been pulled out, although it is entirely possible that
these strings 5 should be left in and merely cut at the skin or bone
surface.
[0183] The tail of the fastener 1D shown in FIGS. 41 and 42 remains the
same 12C suture-clamping collet (embodiment T4) previously seen in FIGS.
38-40.
[0184] An elevational view of a new shaft 111E of an new anchor 11E of yet
another--H2-T1--embodiment of an adjustable button cinch anchor fastener
1E in accordance with the present invention is shown in FIG. 43. The new
shaft 11E is distinguished for having and presenting a large aperture
111E1. Otherwise, the shaft 111E resembles the first, H1, embodiment
shaft 111, because it has the threaded surface. This regular threaded end
mates with the original collet 12 and hoop 14. The head, or anchor, 11E,
however, is definitely an H2 embodiment because of its large aperture
111E1 that permits, for example, a tendon to be passed through it.
[0185] An illustration of this fastener 1E fully deployed, and using the
alternative configuration shaft 111E previously shown in FIG. 43, is
shown in FIG. 44.
[0186] The H2-T1 embodiment of the fastener 1E is particularly for
securing the anterior cruciate ligament. In this embodiment the collet 12
sits on the tibial surface. Tension in the tendon 6 is adjusted by
turning the collet 12, which serves to elongate or shorten the extension
of the shaft 11E.
[0187] This is a very, very important design concept. While the inventor's
own 1994 patent application teaches the desirability of this end, the
previous patent application did not mention the amount of tension or
compression can be regulated through turning the nut. It is strenuously
asserted that the orthopedic fastener device of the present invention is
fully adjustable and re-adjustable in vivo so as to serve to regulate the
tension placed on the tendon 6 attached to it. The H2-T1 embodiment
fastener 1E shown deployed in FIG. 44 is essentially regulating the
compression (or tension) it puts on the tendon 6 as such tendon 6 held
against (or proximately to) the bone 3. This is all very important.
[0188] An embodiment fastener 11F having the "shaft", or in this instance
better described as a "tail", 111F1-111F3 shown in FIGS. 45-55 is new--an
embodiment H2A-T8. This T8 embodiment of the tail is expressed as a
threaded tail 111F1 (best seen in FIGS. 52-55). Instead of being like the
T1 embodiment shaft 111 in which the inside threads 121 on the collet 12
are brought closer to the outside threads 1111 on a rigid shaft 11, in
the T8 embodiment a plug (looks like an upside down trident) 111F2 in the
center of a nut 111F3 is pushed between the two tails of the shaft 111F1.
This pushes the shaft's two tails outward. By keeping the tails outward,
the tails which have threads cut into them on the outside diameter, are
pushed outward into the threads on the inside diameter of the nut 111F3.
The adjustment in compression can thus be made. The plug 111F2 stays
stationary with the two tails of the shaft 111F1 as is particularly shown
in end plan view in FIG. 51.
[0189] The embodiment of the shaft 111F1 shown in FIGS. 52-55 may be
considered a very major variant of the embodiment shaft 111E of FIG. 43;
a variant so large so as to amount to a new embodiment "H2A". However,
and despite the greatly different appearance, the shaft 111F1 can be seen
to be related as a variant to the shaft 111E of, inter alia, FIG. 43,
because now, instead of just an aperture 111E1 in the top of the shaft
111E as in embodiment "E", in the "F" embodiment the entire shaft 111F1
has been split!
[0190] This configuration of the shaft 111F1 can be utilized very nicely
in procedures to affix the anterior cruciate ligament, as previously
discussed in conjunction with FIG. 43 and the previous embodiment of
shaft 111E. The two tails of the shaft 111F1 are made so that they permit
rotation of the nut 111F3 around them when the plug 111F2 is pushed
inward. It is important again to note that this fastener 1F serves
primarily as a tension adjustment device which pulls the tendon (not
shown) to lesser or greater lengths, as opposed to the anchors 11 though
11E (shown in various of FIGS. 1 through 44) which essentially serves to
adjust the amount of compression on the tendon.
[0191] The embodiment of the tail particularly shown in FIG. 56 is yet
another variant--an embodiment T8A--of a fastener, a fastener 1G. In this
variant fastener 1G a center plug 111G2 is attached to a nut 111G3 at an
extension from the side of the nut 111G3. By pushing this plug 111G2 into
the nut 111G3 between the two tails 111F1 (shown in FIGS. 52-55), the
tails 111F1 are pushed outward to contact the threads inside the nut
111G3. Again, this plug 111G2 stays stationary with and between the two
legs of the tail 111F1, while the nut 111G3 rotates around. The plug
111G2 is shown in place in FIG. 57. The thread shown attaching the plug
111G2 to the nut 111G3 breaks upon turning.
[0192] Yet another embodiment of the tail is shown in FIGS. 58 and
59--embodiment T6. In this T6 embodiment a nut 111G3A has internal
threads and simply snaps shut. The amount of holding power this nut has
is questionable due to the fact that it relies on the clasp effect
whereas the hoop 14 of fastener 1 can withstand much more pressure. An H3
embodiment of a shaft 111H of an anchor 11H of a fastener 1H is shown in
FIGS. 60 and 61. This H3 embodiment shaft 111H has a living hinge in
which a head portion rotates on an elongate shaft. The surgeon pushes
this shaft 111H through the hole in the body. Once it is in place, it has
a pin edge which the surgeon hooks onto the bone around the a bore in the
bone. He then pulls back and causes the head portion to rotate into the
transverse position.
[0193] The H3 embodiment of the shaft 111H (of the anchor 11H of the
fastener 1H) of FIGS. 60 and 61 has threads which can take any threaded
type of "nut" or collet, for example the threaded embodiment collet 12
(shown, inter alia, in FIG. 3) or the compressive frictional collet 12B
(shown, inter alia, in FIG. 36). FIG. 61 even shows the fastener 1H of
FIG. 60 with a nut 111G3A (as was shown in FIG. 58) installed!
[0194] By this time it should be coming clear that the head and tail
elements of the fasteners of the present invention can be assembled in
many different ways. Nonetheless to the variations of assembly and use,
all fasteners permit of adjustability of compression or, equivalently,
tension between joined tissues (i) in use, and (ii) while in vivo.
[0195] FIGS. 62 and 63 show a variant of the snap lock (embodiment T6A)
nut 111G3A, now configured as nut 111G3B to hold dual shafts--such as
potentially include even suture (like as suture "shaft" 111C1, see FIGS.
39, 40 and 42). Note that the two holes in the nut 111G3B are not
threaded, but instead have friction ribs like as to embodiment T2, collet
12B. This is clearly because the suture is not threaded.
[0196] Yet another illustration of this split nut embodiment T6a--nut
111G3C--is shown in FIG. 64. However, the embodiment T4--nut or collet
12C--of FIG. 38 could also, and equivalently, have been used to capture
the two strands of suture. The head is now again shown as an H4
embodiment. This H4 embodiment is similar to the H3 embodiment of FIG. 41
except that the axis of the hinge is now transverse to the wing 11D. This
H4 embodiment could have been installed with the marionette strings 5 of
FIG. 41. Instead, yet another installation variant is shown. This is a
sleeve 7 which fits around the suture 111D and wing 11D. The wing 11D is
held in place by this sleeve 7. When the wing 11D clears the ends of the
bone 3, the suture 111D is pulled out of the bone 3 while the sleeve 7 is
held still and the wing 11D breaks off from the sleeve 7 and slides into
the transverse position.
[0197] This is all shown in FIG. 65. In particular, FIG. 65 shows an H4
embodiment head 11D with a T6A embodiment tail consisting of a friction
clamp nut 111G3C. This configuration has some value for the attachment of
the tendon to the femur in the anterior cruciate ligament procedure. This
rotatable wing 11D is installed so it rests on the femur surface. The
suture is attached to the tendon (not shown). The tendon, in turn,
extends through the bone 3 until it exits through the anterior tibia. On
the anterior tibia, the device as shown in FIGS. 43 and 44 is used to
pull on the tendon and vary the tension. Alternatively, at the anterior
tibia, the threaded dual tail device of FIG. 52 can be used with the nut
111G3A (of tail embodiment T6) resting on the exterior surface of the
tibia.
[0198] A variant of the collet, or nut, 12--an embodiment T1A of a collet
nut 12D--is shown in FIGS. 66-68. This T1A embodiment of a collet nut 12D
has a split inner piece which is threaded on its internal diameter. This
internal piece is pushed inside the square cup to close it. The spare cup
has a hole in it to allow the passage of the shaft through it. Once the
T1A embodiment collet nut 12D is threaded on a shaft, the ends of the cup
are then trimmed. This T1a embodiment collet nut 12D may be used on any
threaded shaft and can also be configured with a friction fitting without
the threads. In this case, the nut does not require threading, but simply
radial ridges to push into the suture.
[0199] An embodiment H4A tail--an anchor 111 including a shaft 111I--is
shown in FIGS. 69-71. The embodiment of the head is H4A. This is because
the wing 11I1 has a pin hinge 11I2 which is transverse to the H4
embodiment wing 11I1 as was illustrated, inter alia, in FIG. 65. However,
in the T4A embodiment the wing 11I1 has been modified to go onto a solid
shaft 111I. This solid shaft 111I can accept either a T1 or T1A
embodiment tail, i.e., an anchor 12 or 12D, etc.
[0200] The deployment of the H4A-T1A embodiment is more particularly shown
in FIGS. 72 and 73. The wing 11I1 is pushed into the bone through the
bore in the bone 3 until it (the wing 11I1) is well past the surface of
the bone 3. By shifting the implant slightly off center, the tip of the
wing 11I1 hits the edge of the bore in the surface of the bone 3. The
surgeon then pulls back on the shaft so it comes more out of the bore and
this causes the wing 11I1 to rotate into the transverse position. The
tail is shown as embodiment T1A in both FIGS. 72 and 73. Note how the
inner split nut 12D is pushed inside the shell. This clamps the split nut
12D pieces together so that they clamp together on the shaft 111I.
[0201] A variant of the head embodiment H4--an embodiment H4A--is shown in
FIGS. 72 and 73. These Figures show an H4A head, or anchor, embodiment
having the transverse shaft 111I as was seen in FIG. 69 and the wing 11I1
as was previously seen in FIG. 71. Compare this to the H4 head, or
anchor, embodiment of FIG. 64. The shaft 111I is now solid (in stead of
suture) and will take a threaded nut. Also, FIG. 74 shows the wing 11I1
in the transverse position compressing on surface of the bone 3 while the
other nut is snug. However, their is an obvious similarity in the H4
(FIG. 64) and H4A embodiments in the use of winged anchors.
[0202] The H4A embodiment of FIGS. 72 and 73 is a simplified alternative
to the inventor's own Winged Compression Bolt on which a patent of the
same name issued March 1992. In that device, two separate wings interact
so that they spread and grab on the bone surface. Here, there is but a
single wing. The simplified device can be removed by pushing something up
the bore in the bone and pushing on one side of the single wing. The
device of the previous March 1992 patent does, however, have a very easy
means to remove the implant in that, by removing the outside sleeve, the
wings can rotate out of the way.
[0203] In FIG. 74, the H4A embodiment nut, or collet nut, 12D is deployed
as in FIG. 73 but the excess edges of the nut cup have been cut off.
[0204] Yet another variant of the tail embodiment T1--an embodiment
T1B--is shown in FIG. 75. The same collet nut 12D as in embodiment Ti is
now split, and is now compressed together as collet nut 12E by act of
pushing it into a square cup. The main difference between the T1A and the
T1B variants is that the split collet nut 12D of the T1B embodiment has
the split going the opposite direction of the T1A collet nut 12E
embodiment. Another difference is that the cup does not have the two
tapered sides which guide the split nut into it. In this case, the edges
of the cup are attached to the split inside threaded portion and by
pushing the split nut portion into the cup, the two pieces clamp together
on the threaded shaft. In cases where the shaft is not threaded, the
shaft can have a friction fitting and the inside of the nut would have
annular rings to clamp the suture or shaft. Once the split nut insert is
pushed into place, the edge of the cup snaps onto the nut and holds it in
place.
[0205] A totally new embodiment of the tail--embodiment T6--is shown in
FIG. 76. The T6 embodiment tail is based on a nut 12F that has two
tongues and each tongue hits the ratchets on a shaft 111J (part of an
anchor 11J), as is particularly illustrated in FIGS. 78 and 79. By
pulling the tongues away from the shaft, this nut 12F of the T6
embodiment can be adjusted up or down. The real problem is that this
fastener 1F requires more bulk than any of the fasteners using nuts. The
reason it requires more bulk is because the ratchets move independent of
the outside wall so the outside wall must be thick.
[0206] A plan view of the T6 embodiment tail, part of a fastener 1F, is
shown in FIG. 77.
[0207] A new embodiment head and two variants thereof--embodiments H5, H5A
and H5B--are respectively shown in FIGS. 78, 79 and 81. In the H5, H5A
embodiments respectively of FIGS. 78 and 79 shafts 111J1 and 11J2 two
springy wings provide the anchoring of the bone side. In both these
variants, the wings of each shaft 111J1, 111J2 are compressed to get into
the bore in the bone and then they spring open to hold the anchor in
bone. By pulling the anchor against the spring wings, they spread further
into the bone.
[0208] All the H5, H5a, and H5b embodiment anchors 11J1, 11J2, 11J3 (refer
to FIGS. 78-81) are distinguished for requiring compression to fit them
into the bore within the bone. After they are inserted to their final
destinations they are then pulled back and permitted to grab the bone
wall of the bore. The H5 embodiment is particularly preferably made of
plastic. The H5a embodiment is the same as the H5 embodiment except that
it is particularly preferably made of metal. In this construction
material it should be compared with the anchor product of Mitek.
Meanwhile, the H5b variant (shown in FIG. 81) should be compared with the
"harpoon" orthopedic fastener of Arthrotec where the head is a
funnel-shaped cone with slits.
[0209] Both FIGS. 77 and 78 show the T6 embodiment of the tail--the
ratchet system first introduced at FIG. 52, et seq.
[0210] Another showing of this T6 embodiment ratchet tail in accompaniment
with a new, H7, embodiment head is shown in FIG. 80. In the H7 embodiment
a threaded shaft 111K is first screwed into the bone, and then a 12F
rachet tail is put on. This H7 embodiment of the head--in which the a
rachet tail 12F mates with a screw-in shaft 111K--can also be utilized
with the T1 embodiment single shaft 111 as long as the shaft 111K of FIG.
80, embodiment T6, is appropriately switched.
[0211] A variant of the T6 embodiment--embodiment T6A--is shown in FIG. 81
along with an H5A embodiment head. In this T6a embodiment tail a two-part
shaft 111J3 does not have the nut 12F with its tongues. It is merely a
nut 12H which contacts the ratchets and maintains compression.
[0212] The nut 12H of this T6A embodiment is shown in FIG. 82. There is
only the outside wall to the nut, and the two shafts are springy outward.
By compressing these shafts inward, the nut 12H is put on. The shafts are
let go once they are inside the nut 12H and compress against the inside
diameter of the nut 12H.
[0213] FIGS. 83 and 84 show yet another variant embodiment of T6, now
called embodiment T6B. In this case, the ratchets are on the outside of
the two shafts as in T6a. However, there is now a small cylinder in the
nut 121 which is turned to put an outward clamping force on the two tails
of the two-part shaft 111J3, and so as to push them into the inside
diameter of the walls of the nut 121.
[0214] Another embodiment head--embodiment H9--consisting of a two-part
shaft 111K which is ratcheted on the outside of each of its two tails (as
is a T6A or T6B embodiment tail) is shown in FIG. 85. The illustrated H9
head embodiment uses a shaft 111K that is particularly split at its
furthest distal extent. There is a ball with a string attached at this
region which is pulled by the spring to make the split head and hold the
device in the bone.
[0215] The several embodiments of the present invention present, in
addition to their supremely important ability to adjustably compress and
to tension soft tissues held against hard tissues, at least two further
advantages. In the first place they are quick to install, and to adjust,
and to re-adjust. They are very quickly (i) inserted, and arranged to
capture soft tissue, and then (ii) adjusted in gross position, normally
by sliding. Once positioned approximately correctly, they are easily
infinitely finely adjustable and readjustable so as to vary the force of
attachment both up and down. A orthopedic surgeon without benefit of long
and frequent experience in how tightly to pull things together so as to
achieve best final results with conventional orthopedic fastener systems
can generally achieve superior results with the fastener system of the
present invention. It is even possible to quantify the force levels of
attachment, such as by using a small pull scale during surgery and
adjusting and re-adjusting compressions and tensions both upwards and
downwards as desired, and until those precise force levels best believed
to promote healing are achieved.
[0216] Second, it should appreciated that many, even most, embodiments of
the orthopedic fastener of the present invention are not only robust--as
best suit their usage in orthopedic surgeries upon the major joint so the
body--but are--nonetheless to being reasonably compact and adjustable at
a fine scale--built from parts that are sizable, and not dependent upon
fine structure and detail for correct operation. In one sense this means
that these parts could likely be crudely made at high mechanical
tolerances and still suffice to function perfectly correctly. This, of
course, is neither the intent, nor any particular advantage to the
present invention (at least as it might be fabricated and used in the
first world such as the United States, circa 1995).
[0217] What this also means is that the considerably robust parts of the
several considerably robust embodiments of the present invention need not
be invariably be made from finest steels, exotic composite material, and
the like before they are well strong enough to reliably perform their
function. Thy may in fact typically be made from biodissolvable plastics,
and/or (ii) collagen. Both of these substances are notorious for having
physical properties of strength, flexibility, and brittleness that are as
inferior as are their strengths in bio-compatibility, and their
substantial inability to leave anything in the body, are superior. In
particular, it presently highly desirable to use fasteners and fixtures
in the body which in no way might, or which arguably might, be causative
of problems--not limited to orthopedic problems, and specifically
including immune system problems--after the lapse of years or decades.
This dictates fasteners and fixtures that (i) perform their function, and
then (ii) dissolve and disappear innocuously. This dictates the use of
bio-absorbable materials. The fasteners of the present invention have
mechanical characteristics, and requirements, that make them well
suitable of fabrication from such materials.
[0218] In accordance with the preceding explanation, variations and
adaptations of orthopedic fasteners in accordance with the present
invention will suggest themselves to a practitioner of the orthopedic
appliance design arts. For example, once the concept of a "button head"
that first "slides" in gross linear motion along some "shaft" so as to be
positioned, and is then adapted--such as by "clamping"--to be finely
adjusted in lineal position against a strong force is recognized, then
there are diverse mechanical means of accomplishing this two-part
positioning, and adjustable holding. For example, a traveler on a rachet
shaft can both (i) slide and then, a proper gross position along the
shaft having been assumed, be toggled to a shaft-grasping mode where each
further measure of liner motion is caught by a rachet pawl. The concept
is analogous to using the rachet action of a common socket wrench along a
linear, as opposed to a circular, ratchet track so as to undergo linear,
as opposed to a circular, motion.
[0219] In accordance with these and other possible variations and
adaptations of the present invention, the scope of the invention should
be determined in accordance with the following claims, only, and not
solely in accordance with that embodiment within which the invention has
been taught.
* * * * *