U.S. patent application number 11/057876 was filed with the patent office on 2005-10-20 for soft tissue repair apparatus and method.
Invention is credited to Miller, Drew.
Application Number | 20050234460 11/057876 |
Document ID | / |
Family ID | 34886083 |
Filed Date | 2005-10-20 |
United States Patent
Application |
20050234460 |
Kind Code |
A1 |
Miller, Drew |
October 20, 2005 |
Soft tissue repair apparatus and method
Abstract
The present invention relates to a biological soft tissue
implant device and method. The implant device is designed for use
in the treatment of biological soft tissue and to be capable of
interacting with nearby biological soft tissue or bone so as to
anchor the implant device and biological soft tissue being treated.
In one embodiment, the implant device prevents a biceps tendon from
retracting through the bicipital sheath after a tenotomy is
performed.
Inventors: |
Miller, Drew; (Atlanta,
GA) |
Correspondence
Address: |
RENNER OTTO BOISSELLE & SKLAR, LLP
1621 EUCLID AVENUE
NINETEENTH FLOOR
CLEVELAND
OH
44115
US
|
Family ID: |
34886083 |
Appl. No.: |
11/057876 |
Filed: |
February 14, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60544787 |
Feb 13, 2004 |
|
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Current U.S.
Class: |
606/232 ;
606/327; 606/329; 606/330 |
Current CPC
Class: |
A61B 2017/0464 20130101;
A61B 2017/0429 20130101; A61F 2/0811 20130101; A61B 2017/0414
20130101; A61F 2002/0835 20130101; A61F 2002/0882 20130101; A61B
2017/00557 20130101; A61B 2017/0459 20130101; A61F 2002/0829
20130101; A61F 2002/087 20130101; A61B 2017/0427 20130101; A61B
2017/0461 20130101 |
Class at
Publication: |
606/072 |
International
Class: |
A61B 017/58 |
Claims
What is claimed is:
1. A biological soft tissue implant device comprising: a fastener
attachable to a first biological soft tissue; and an anchor capable
of interacting with a second biological soft tissue or a bony
tissue such that retraction of the first biological soft tissue is
limited in at least one direction.
2. The implant device of claim 1 wherein the fastener comprises at
least one of: at least one spike, ridges, grooves, at least one
latch, at least one suture passing through the first biological
soft tissue, at least one suture wrapped around the first
biological soft tissue, at least one hinge, at least one crimping
deformation, engageable cooperating parts, at least one gripping
surface, at least one retaining ring, at least one gripping beam,
or at least one hook and capture mechanism.
3. The implant device of claim 2 wherein the engageable cooperating
parts are at least one of: snapably engageable, slidably
engageable, hookably engageable, rotatably engageable, or biasedly
engageable.
4. The implant device of claim 1 wherein the anchor comprises at
least one of: at least one barb, at least one spike, at least one
flap, at least one bar, at least one beam, at least one hook, a
pointed implant end configured to anchor when the implant device
toggles, or at least one expansion mechanism.
5. The implant device of claim 1 wherein the fastener comprises at
least one engaging element and at least one locking element.
6. The implant device of claim 5 wherein the at least one engaging
element comprises at least one of: at least two cooperating parts
for trapping the first biological soft tissue, at least one
gripping surface, a suture passable through the first biological
soft tissue, a suture wrappable around the first biological soft
tissue, a suture and component combination wherein the suture
clinches the first biological soft tissue against the component, at
least one hook and capture mechanism, at least one spike for
piercing the first biological soft tissue, or at least one barb for
piercing the first biological soft tissue.
7. The implant device of claim 5 wherein the at least one locking
element comprises at least one of: snap-fitting parts, crimping,
biasing, at least one knot, press-fitting, at least one thread, at
least one barb, at least one pin, at least one receiver, at least
one retaining surface, riveting, swaging, cold shaping,
welding.
8. The implant device of claim 1 further comprising at least one
gripping surface for improving fixation strength.
9. The implant device of claim 8 wherein the at least one gripping
surface comprises at least one of: at least one barb, at least one
spike, at least one hole, at least one slot, ridges, grooves,
serrations, teeth, or surface texture.
10. The implant device of claim 1 wherein the retraction of the
first biological soft tissue increases the interaction between the
implant device and the second biological soft tissue or the bony
tissue.
11. The implant device of claim 1 wherein tension on the first
biological soft tissue causes toggling of the implant device,
thereby causing interaction with a second biological soft
tissue.
12. The implant device of claim 1 wherein the implant device is
attachable to the first biological tissue such that the tension of
the first biological soft tissue on one side of the biological soft
tissue implant is less than the tension of the biological soft
tissue on the opposing side of the biological soft tissue
implant.
13. The implant device of claim 1 wherein the fastener is
attachable to a biceps tendon.
14. The implant device of claim 13 wherein the anchor is capable of
interacting with a transverse ligament.
15. The implant device of claim 13 wherein the anchor is capable of
interacting with a sheath of the biceps tendon.
16. A biological soft tissue implant device comprising: a fastener
attachable to a first biological soft tissue; and an anchor capable
of interacting with a second biological soft tissue or a bony
tissue such that when tension on the first biological soft tissue
is relieved on one side of the biological soft tissue implant
device, the interaction of the anchor and second biological soft
tissue or bone creates tension on the opposite side of the
biological soft tissue implant.
17. The implant device of claim 16 wherein the fastener comprises
at least one of: at least one spike, ridges, grooves, at least one
latch, at least one suture passing through the first biological
soft tissue, at least one suture wrapped around the first
biological soft tissue, at least one hinge, at least one crimping
deformation, engageable cooperating parts, at least one gripping
surface, at least one retaining ring, at least one gripping beam,
or at least one hook and capture mechanism.
18. The implant device of claim 17 wherein the engageable
cooperating parts are at least one of: snapably engageable,
slidably engageable, hookably engageable, rotatably engageable, or
biasedly engageable.
19. The implant device of claim 16 wherein the anchor comprises at
least one of: at least one barb, at least one spike, at least one
flap, at least one bar, at least one beam, at least one hook, a
pointed implant end configured to anchor when the implant device
toggles, or at least one expansion mechanism.
20. The implant device of claim 16 wherein the retraction of the
first biological soft tissue increases the interaction between the
implant device and the second biological soft tissue or the bony
tissue.
21. A method for treating a first biological soft tissue comprising
attaching a biological soft tissue implant to first damaged
biological soft tissue such that the first biological soft tissue
implant is capable of interacting with a second biological soft
tissue or bone to prevent the first biological soft tissue from
retracting beyond a predetermined position.
22. The method of claim 21 further comprising tensioning the first
biological soft tissue prior to attaching the biological soft
tissue implant.
23. The method of claim 21 wherein the retraction of the first
biological soft tissue strengthens interaction of the biological
soft tissue implant with the second biological soft tissue or the
bony tissue.
24. The method of claim 21 wherein the biological implant is
attached to the first biological tissue such that the tension on
the first biological soft tissue on one side of the biological soft
tissue implant is less than the tension on the first biological
soft tissue on the other side of the biological soft tissue
implant.
25. The method of claim 24 further comprising resecting the first
biological soft tissue on the side of the biological soft tissue
implant having less tension.
Description
FIELD OF THE INVENTION
[0001] The present invention relates generally to prostheses and
methods for treating damaged biological soft tissue, and more
specifically to a system and method for preventing biological soft
tissue from retracting when severed and/or resected.
BACKGROUND OF THE INVENTION
[0002] The present invention may be applicable to the treatment of
biological soft tissue either before or after the damaged
biological soft tissue is severed and/or resected. This can be
accomplished by the introduction of an implant device of the
present invention. The present invention is described with
reference to a damaged biceps tendon, but one of skill in the art
will recognize that the present invention is not limited to the
treatment of biceps tendons, and will also recognize the
applicability of the present invention to other biological soft
tissues.
[0003] Referring initially to FIG. 1A, a frontal view of the normal
right human shoulder is illustrated. The biceps tendon 10 is a
tendon that joins part of the biceps brachii, (i.e., the biceps
muscle) to the shoulder. Specifically, the biceps tendon 10 inserts
on the most superior portion of the glenoid labrum of the scapula
12 in the shoulder and extends downwardly to the biceps muscle 16
in the upper arm. The biceps tendon 10 is often referred to as the
"long head" of the biceps brachii. As can be further seen in FIG.
1A, the short head 24 of the biceps brachii also functions to
attach the biceps muscle 16 to the shoulder. The biceps tendon 10
lies along the bicipital groove 18 in the humerus 20 and passes
beneath a bicipital sheath 22. It is believed that the biceps
tendon 10 contributes to stability of the shoulder, particularly
when a patient's arm is disposed in certain orientations.
[0004] As a patient ages, the biceps tendon may become painful,
inflamed, or may degenerate and fray beneath its upper attachment
point, the point of attachment at the glenoid cavity. The
degeneration and fraying of the biceps tendon is often due to
abrasion against adjacent shoulder structures. This can result in
tearing and cause the patient significant pain. One method of
treating the pain caused by a partially torn biceps tendon 10 is to
perform a procedure called a tenotomy. One benefit of a tenotomy is
that it can easily be performed arthroscopically. As shown in FIG.
1B, a tenotomy involves severing the biceps tendon 10 at its upper
end 26, so that it is detached from the glenoid. This procedure is
typically effective at relieving the patient's pain symptoms caused
by a degenerative and/or frayed biceps tendon. Despite severing the
biceps tendon as part of a tenotomy, it has been found that the
remaining structure supporting the biceps muscle 16, including the
short head 24, provides adequate anterior stability for the
shoulder, especially because the typical tenotomy patient is
usually older and less physically active by the time the procedure
is required. Since stability can be maintained despite a severed
biceps tendon, a frayed and/or degenerative biceps tendon can be
severed to alleviate associated pain.
[0005] Following a tenotomy procedure, patients often experience
undesirable side effects. One of the most common side of these
effects is known informally as a "Popeye Sign." As shown in FIG.
1C, a Popeye Sign develops when the biceps tendon 10 retracts down
through the bicipital sheath 22. The retraction of the biceps
tendon 10 causes the biceps 16 to sag and bulge in an unsightly
way, as shown. The patient must therefore live with the resultant
unsightly appearance and may also suffer from muscle cramping or
aching. Consequently, this potential side effect is a significant
deterrent to undergoing a tenotomy procedure and realizing the
benefits of substantial pain relief.
[0006] Other approaches have been developed to try to obtain the
benefits of pain relief while avoiding the side effect of a "Popeye
Sign." One such approach, known as "biceps tenodesis," can be
performed either by means of open or arthroscopic surgery. When
performing a biceps tenodesis, the biceps tendon 10 is severed just
as when performing a tenotomy. Unlike the tenotomy, however, in a
biceps tenodesis, the biceps tendon 10 is sutured to the humerus 20
within the bicipital groove 18, using suture anchors to prevent the
tendon from slipping downwardly through the sheath 22. Such a
procedure is described in an article entitled Arthroscopic Biceps
Tenodesis Using the Percutaneous Intra-articular Transtendon
Technique, by Sekiya et al. published in the December 2003 edition
Arthroscopy: The Journal of Arthroscopic and Related Surgery, Vol.
19, No. 10 (pp. 1137-1141). While a biceps tenodesis procedure is
often successful, if performed using open surgical techniques, as
is the present state of the art, it results in an unsightly scar
and an extended recovery period when compared to a tenotomy. The
arthroscopic procedure described in the identified article avoids
the scarring issue, but is complex and difficult for most surgeons
to perform using today's instrumentation. Moreover, the
arthroscopic procedure still generally requires a longer recovery
period than a simple tenotomy.
[0007] Thus, it is desirable for surgeons to be able to perform a
procedure similar to a simple tenotomy and receive results
comparable to those achieved by tenodesis.
BRIEF SUMMARY OF THE INVENTION
[0008] According to an aspect of the invention, there is provided a
biological soft tissue implant device comprising a fastener
attachable to a first biological soft tissue; and an anchor capable
of interacting with a second biological soft tissue or a bony
tissue such that retraction of the first biological soft tissue is
limited in at least one direction.
[0009] According to another aspect of the invention, there is
provided a biological soft tissue implant device comprising a
fastener attachable to a first biological soft tissue; and an
anchor capable of interacting with a second biological soft tissue
or a bony tissue such that when tension on the first biological
soft tissue is relieved on one side of the biological soft tissue
implant device, the interaction of the anchor and second biological
soft tissue or bone creates tension on the first biological soft
tissue on the opposite side of the biological soft tissue
implant.
[0010] According to another aspect of the invention, there is a
method for treating a biological soft tissue comprising attaching a
biological soft tissue implant to the damaged biological soft
tissue such that the biological soft tissue implant is capable of
interacting with a second biological soft tissue or a bony tissue
to prevent the damaged biological soft tissue from retracting
beyond a predetermined position.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] FIG. 1A is a view from the front of a typical normal right
shoulder, showing the biceps tendon and related structure;
[0012] FIG. 1B is a view similar to FIG. 1A, wherein the biceps
tendon has been cut in a tenotomy procedure in order to alleviate a
patient's pain;
[0013] FIG. 1C is a view similar to FIGS. 1A-B, wherein the biceps
tendon has slipped down through the bicipital sheath after the
biceps tenotomy procedure, causing the biceps muscle to protrude or
bulge in an unsightly manner known as a "Popeye Sign";
[0014] FIG. 2A is similar to FIGS. 1A-C and illustrates a
biological soft tissue implant attached to the biceps tendon in
accordance with the present invention;
[0015] FIG. 2B is similar to FIG. 2A and shows the biological soft
tissue implant of 2A anchoring and interacting with the bicipital
sheath as the biceps tendon retracts;
[0016] FIG. 3 illustrates a perspective view of an embodiment of
the biological soft tissue implant of FIGS. 2A-B;
[0017] FIG. 4 illustrates a perspective view of another embodiment
of the biological soft tissue implant of FIGS. 2A-B;
[0018] FIGS. 5A-C illustrate an embodiment of a biological soft
tissue implant having cooperating parts that are snapably
engageable where the implant is in different locking positions;
[0019] FIGS. 5D-E are perspective views of the cooperating parts of
FIGS. 5A-5C;
[0020] FIGS. 6A-C illustrate an embodiment of a biological soft
tissue implant having cooperating parts that are snapably
engageable where the implant is in different locking positions;
[0021] FIGS. 6D is an elevation view of an elevation view of the
cooperating parts of the implant of FIGS. 6A-C;
[0022] FIGS. 7A-C illustrate perspective views of the cooperating
parts that are slidably engageable and shown at different positions
of engagement;
[0023] FIGS. 7D-E illustrate perspective views of one of the
cooperating parts 122a of FIGS. 7A-C;
[0024] FIGS. 7F-G illustrate perspective views of the other
cooperating part of FIGS. 7A-C;
[0025] FIGS. 7H-J illustrate elevation views of the implant of
FIGS. 7A-C engaging a biological soft tissue;
[0026] FIGS. 8A-C illustrate perspective views of the cooperating
parts that are slidably engageable and shown at different positions
of engagement;
[0027] FIGS. 8D-E illustrate perspective views of one of the
cooperating parts of FIGS. 8A-C;
[0028] FIGS. 8F-G illustrate perspective views of the other
cooperating part of FIGS. 8A-C;
[0029] FIG. 8H illustrates another perspective views of the implant
of FIGS. 8A-C showing the anchor;
[0030] FIG. 8I is a plan view of the implant of FIGS. 8A-C as it
might look inside a cannula;
[0031] FIGS. 9A-D illustrate perspective view of a toggle implant
in an open position and in three locked positions;
[0032] FIGS. 9E-F illustrate perspective views of cooperating parts
of the implant of FIGS. 9A-C;
[0033] FIG. 9G illustrates a perspective view of the reverse side
of the implant of the implant of FIGS. 9A-C;
[0034] FIGS. 10A-D illustrate perspective view of a toggle implant
in an open position and in three locked positions;
[0035] FIGS. 10E-F illustrate perspective views of cooperating
parts of the implant of FIGS. 10A-C;
[0036] FIG. 10G illustrates a perspective view of the reverse side
of the implant of the implant of FIGS. 10A-C;
[0037] FIGS. 11A-D illustrate perspective view of a toggle implant
in an open position and in three locked positions;
[0038] FIGS. 11E-F illustrate perspective views of cooperating
parts of the implant of FIGS. 11A-C;
[0039] FIG. 11G illustrates a perspective view of the reverse side
of the implant of the implant of FIGS. 11A-C;
[0040] FIGS. 12A-G illustrate another embodiment of a toggle
biological soft tissue implant;
[0041] FIGS. 13A-F illustrate another embodiment of a toggle
biological soft tissue implant;
[0042] FIGS. 14A-B illustrate perspective views of an embodiment of
a clip-type biological soft tissue implant;
[0043] FIG. 14C illustrates a plan view of the implant of the
embodiment of FIGS. 14A-B;
[0044] FIGS. 15A-C illustrate perspective views of other
embodiments of clip-type biological soft tissue implants;
[0045] FIG. 15D illustrates a plan view of another embodiments of
clip-type biological soft tissue implant;
[0046] FIGS. 16A-B illustrate front elevation views of embodiments
of clip-type biological soft tissue implants with living
hinges;
[0047] FIG. 17A is similar to FIG. 2A and illustrates a biological
soft tissue implant attached to the biceps tendon in accordance
with the present invention;
[0048] FIG. 17B is similar to FIG. 17A and shows the biological
soft tissue implant of 17A anchoring and interacting with the
bicipital sheath as the biceps tendon retracts;
[0049] FIG. 18 illustrates a perspective view of the biological
soft tissue implant of FIGS. 17A-B;
[0050] FIGS. 19A-B illustrate perspective views of another
embodiment of the biological soft tissue implant alone and
installed about a biological soft tissue;
[0051] FIGS. 20A-B illustrate perspective views of another
embodiment of the biological soft tissue implant alone and
installed about a biological soft tissue;
[0052] FIGS. 21A-D illustrate perspective views of another
biological soft tissue implant attached to the biceps tendon and
the procedure associated therewith in accordance with the present
invention;
[0053] FIGS. 22A-D illustrate another biological soft tissue
implant attached to the biceps tendon and the procedure associated
therewith in accordance with the present invention;
[0054] FIGS. 23A-B illustrate top and bottom perspective views of
another embodiment of a biological soft tissue implant having
multiple cooperating parts that are biasedly engageable;
[0055] FIGS. 23C illustrates top plan view of the implant of FIGS.
23A-B as it might look inside a cannula;
[0056] FIGS. 24A-B illustrate perspective views in both open and
close positions, respectively, of another embodiment of a slidably
engageable implant with a hook and capture mechanism;
[0057] FIGS. 24C-D illustrate perspective views of cooperating
parts of the implant of FIGS. 24A-B;
[0058] FIG. 25A illustrates a perspective view of an embodiment of
a soft tissue implant designed to have a suture wrapped around the
implant;
[0059] FIGS. 25B-D illustrate top, side and bottom elevation views,
respectively, of the implant of FIG. 25A in conjunction with a
suture;
[0060] FIGS. 26A-B illustrate open and closed perspective views of
another embodiment of a biological soft tissue implant having
cooperating parts that are snapably engageable;
[0061] FIG. 27 illustrates a perspective view of another embodiment
of a biological soft tissue implant having cooperating parts that
form a retaining ring;
[0062] FIG. 28 illustrates a perspective view of another embodiment
of a biological soft tissue implant having a retaining ring and two
laterally extending beams with hooks;
[0063] FIGS. 29A-B illustrate perspective and front elevation views
of another embodiment of a biological soft tissue implant having
multiple biasedly engageable parts; and
[0064] FIGS. 30A-B illustrate perspective and front elevation views
of another embodiment of a biological soft tissue implant having
multiple biasedly engageable parts; and
[0065] FIGS. 31A-B illustrate perspective and front elevation views
of another embodiment of a biological soft tissue implant having
multiple biasedly engageable parts and including a hook and capture
mechanism.
DETAILED DESCRIPTION OF THE INVENTION
[0066] Turning now to FIG. 2A, a biological soft tissue implant 100
is shown attached to a first biological soft tissue, the biceps
tendon 10 in this example. FIG. 2B illustrates the implant 100 of
FIG. 2A anchoring and interacting with a second biological soft
tissue, in this case the bicipital groove 18 and bicipital sheath
22, as the biceps tendon 10 retracts into the bicipital sheath 22.
Together, FIGS. 2A-B illustrate an inventive method for repairing a
damaged biological soft tissue 10.
[0067] The implant 100 is configured such that once the biological
soft tissue 10 is severed, as shown in FIG. 2B, the implant
interacts with a second biological soft tissue or a bone to prevent
the severed biologic soft tissue 10 from retracting beyond a
predetermined position. In the example illustrated in FIGS. 2A-B,
the tendon 10 is severed from the glenoid, such as during a
tenotomy. Without the aid of the implant 100 of the present
invention, the tendon 10 will likely retract down through the
bicipital sheath 22. This causes what is known as the Popeye Sign
condition, as is described above.
[0068] If the implant 100 is attached to the biceps tendon 10 prior
to severing the tendon, however, the implant 100 will interact with
the bony bicipital groove 18 and the tissue of the bicipital sheath
22, thereby capturing the biceps tendon 10 within the bicipital
groove and causing tension on the tendon 10 between the implant 100
and the bicep 16. This prevents the tendon 10 from fully retracting
beyond a predetermined position. This predetermined position may be
any position that prevents an undesired effect associated with
severing the biological soft tissue, such as a Popeye Sign. After
capturing the tendon, the implant 100 places tension on one side of
the biological soft tissue that is less than the tension placed on
the biological soft tissue on the other side of the biological soft
tissue implant 100. Moreover, any retraction of the first
biological tissue further increases the interaction of the
biological soft tissue implant 100 with the second biological soft
tissue or the bony tissue. In other words, as the first biological
tissue retracts, the implant 100 strengthens its connection or
attachment with or to the second biological tissue.
[0069] It will be understood by those skilled in the art that the
implant 100 may also be attached to the biological soft tissue
after severing the biological soft tissue. In this case, the
surgeon would sever the biological soft tissue while maintaining
tension on the biological soft tissue before severing so that it
does not retract upon being cut. In other words, a surgeon places
tension on the damaged biological soft tissue prior to attaching
the biological soft tissue implant. Before releasing the tension on
the tissue, the surgeon would then attach the implant 100 to the
tissue.
[0070] It should be noted that the bicipital sheath 22 boundaries
include the transverse ligament and the bony bicipital groove 18.
Therefore, the implant 100 may be configured so that it is of a
greater size in one dimension than in another (i.e. it is in a
shape other than round). Thus, when the implant 100 engages the
bicipital groove 18, sheath 22 or transverse ligament, it may tend
to self-align by action of the bicipital groove 18, and thus engage
the boundaries of the sheath 22. Thus, fixation of the implant 100
may be achieved by engagement with the tunnel bounded by the
bicipital sheath 22 and transverse ligament and the bony bicipital
groove 18.
[0071] FIG. 3 illustrates the specific embodiment of the implant
shown in FIGS. 2A-B having a fastener 102 and an anchor 104. The
fastener 102 of the implant 100 is attached to the biceps tendon 10
as described above, either before of after severing the tendon 10.
The retaining ring 110 of the fastener 102 is placed about the
tendon 10 and squeezed or crimped to engage the tendon 10, the
spikes 112 are forced to engage the tendon 10 and further secure
the fastener 102 with the tendon 10. The crimping of the implant
100 can be accomplished by any crimping tools known in the art.
Preferably, the crimping tools are configured so that the implant
100 can be crimped during an arthroscopic procedure without causing
the procedure to become any more invasive due to crimping the
implant 100. The spikes 112 may be forced into the tendon 10 or
even penetrate through the tendon 10 to provide a secure connection
or anchorage of the implant 100.
[0072] Once the fastener 102 is attached to the tendon 10, the
implant 100 is allowed to move down until the anchor 104 of the
implant 100 engages an outer surface of the sheath 22. This
engagement occurs when the tab 116 of the anchor 104 is allowed to
contact an outer surface of the sheath 22. Thus, the implant 100
attaches to the tendon 10 via the fastener 102 and then anchors to
the sheath 22 via engagement of the tab 116 of the anchor 104 with
the outer surface of the sheath 22. The securing of the fastener
102 can occur either before or after the severing of the biceps
tendon 10 from the glenoid, as previously described. Likewise the
engagement of the anchor 104 of the implant 100 with the sheath 22
can occur either before or after the severing of the biceps tendon
10.
[0073] Embodiments of the present inventions includes a variety of
biological soft tissue implants designed to attach to damaged
biological soft tissue, such as a tendon that has been torn or
detached on one side. Each of the various implant embodiments
includes a fastener for attaching the implant to a damaged
biological soft tissue. The fasteners may include, for example,
alone or in combination, spikes, ridges, grooves, at least one
latch, at least one suture passing through the first biological
soft tissue, at least one suture wrapped around the first
biological soft tissue, at least one hinge, at least one crimping
deformation, engageable opposing parts, at least one retaining
ring, at least one gripping beam, at least one hook and capture
mechanism, as well as other like fasteners. The mechanism by which
the opposing parts engage may also vary. For example, the
engageable opposing parts may be snapably engageable, slidably
engageable, hookably engageable, rotatably engageable, or biasedly
engageable.
[0074] The various types of fasteners may also include both an
engaging element for engaging the implant with the damaged
biological soft tissue and a locking element to maintain that
engagement in place. The engaging element may include, alone or in
combination, at least two cooperating parts for trapping the first
biological soft tissue, a suture passable through the first
biological soft tissue, a suture wrappable around the first
biological soft tissue, a suture and component combination wherein
the suture clinches the first biological soft tissue against the
component, at least one hook and capture mechanism, at least one
spike for piercing the first biological soft tissue, or at least
one barb for piercing the first biological soft tissue, as well as
other elements suitable for engaging biological soft tissue or
bone.
[0075] The locking element may also vary. For example, the locking
element may include, alone or in combination, snap-fitting parts,
crimping, biasing, at least one knot, press-fitting, at least one
thread, at least one barb, riveting, swaging, cold shaping, welding
or the like.
[0076] In order to improve engagement with the damaged biological
soft tissue, the implant may also include, alone or in combination,
one or more gripping surfaces, which may have barbs, spikes, holes,
slots, ridges, grooves, serrations, teeth, textured surfaces, or
other gripping mechanisms.
[0077] Each of the various implant embodiments also includes an
anchor that is capable of interacting with another biological soft
tissue or bone in order to prevent the damaged biological soft
tissue from retracting. The anchor of each of the various
embodiments may be designed such that once tension is tension on
the damaged biological soft tissue is relieved on one side of the
biological soft tissue implant device (such as by severing the
damaged biological soft tissue or by a surgeon releasing severed
biological soft tissue) the interaction of the anchor and second
biological soft tissue or bone creates tension on the opposite side
of the biological soft tissue implant.
[0078] The specific mechanism by which the anchor interacts with
another biological soft tissue or bone may vary. For example, the
anchor may include, alone or in combination, at least one barb, at
least one spike, at least one flap, at least one bar, at least one
beam, at least one hook, a pointed implant end configured to anchor
when the implant device toggles, at least one expansion mechanism,
or other like structures suitable for anchoring the implant to
biological soft tissue or to bone. Where the anchor is a pointed
implant end configured to anchor when the implant device toggles,
tension on the damaged biological soft tissue may cause the
toggling of the implant device, thereby causing the interaction
with a second biological soft tissue.
[0079] As will be understood by one of skill in the art, the
implants may be fabricated of any known biocompatible material,
including suitable metals, plastics, and/or resorbable materials.
Plastics may be more suitable for some embodiments, while metal may
be more suitable for others.
[0080] It will also be understood by one of skill in the art that
the implants of the present invention may be configured for use
during arthroscopic procedures. Arthroscopic procedures are often
performed with the aid of a cannula. Thus, it may be preferable for
the implants of the present invention to fit within the diameter of
a cannula.
[0081] Turning to FIG. 3, one embodiment of the implant 100 of the
present invention is illustrated. As illustrated in FIG. 3, the
implant 100 includes a fastener 102 and anchor 104. The fastener
102 includes spikes 112 and a retaining ring 110, as well as a
gripping surface 156 with a hole 114 extending through the gripping
surface 156. The anchor 104 of the implant 100 of FIG. 3 is a tab
116. In practice, the implant 100 of FIG. 3 is either a flexible
material such as a plastic or a crimpable material such as a metal
appropriate for implant uses. The fastener 102 acts as a retaining
ring 110 with a gripping surface 156 located on the interior
surface of the retaining ring 110 for engaging the exterior surface
of the tendon.
[0082] In operation, the retaining ring 110 of the fastener 102 is
placed around the tendon 10. If the fastener 102 is fabricated of a
flexible material, it will typically have a smaller inner diameter
than the outer diameter of the tendon and can be opened via
pressure or other conventional means in order to slip it around the
tendon 10. Once the fastener 102 is slipped around the tendon 10,
the pressure is removed and the retaining ring 110 closes securely
around the outer diameter of the tendon. If the fastener 102 is
fabricated from a metal, it can be crimped about the outer diameter
of the tendon in order to secure it in place around the tendon.
Again, the implant 100 may be crimped using any crimping tools
known in the art. Preferably, the crimping tools are configured so
that the implant 100 can be crimped during an arthroscopic
procedure without causing the procedure to become any more invasive
due to crimping the implant 100.
[0083] Turning now to FIG. 4, an alternate embodiment of the
implant of FIG. 3 is illustrated. The implant 100 includes a
fastener 102 and anchor 104. The fastener 102 includes spikes 112
and a retaining ring 110 and a hook 118 as an anchor 104. This
implant 100 is deployed in a manner similar to that of FIG. 3
except that the hook 118 may rest against the top of the sheath 22
or mat attach to an inner surface of the sheath 22. One of skill in
the art will readily appreciate that spikes do not have to be
included if the crimping force is significant enough to obtain a
strong attachment between the gripping surface 156 and the tendon
10.
[0084] FIGS. 5A-E illustrate an embodiment of a biological soft
tissue implant having cooperating parts 122a and 122b that are
snapably engageable. FIGS. 5A-C illustrate is a biological soft
tissue implant 100 having a fastener 102 and anchor 104. The anchor
104 includes a hook 118. The fastener 102 includes cooperating
parts 122a and 122b, which are snapably engageable opposing parts
having gripping surfaces 156a and 156b with holes 114 on gripping
surfaces 156b. FIGS. 5D-E are perspective views of the cooperating
parts 122a and 122b, respectively. The fastener 102 can be
described as including both an engaging element 106 and a locking
element 108. The engaging element 106 includes the cooperating
parts 122a and 122b for trapping the biological soft tissue, the
spikes 112 and the gripping surfaces 156a and 156b with holes 114.
The locking element 108 includes snap-fitting parts 120, which
include teeth 152 and receivers 158.
[0085] In operation the fastener 102 engages the biological soft
tissue between the cooperating parts 122a and 122b. When the
cooperating parts 122a and 122b are brought together with the soft
tissue therebetween, the fastener 102 engages the biological soft
tissue. Specifically, the spikes 112 of the fastener 102 puncture
the tissue and engage the holes 114. Once engaged, the fastener 102
also includes a locking element 108. The locking element 108 in the
specific embodiment shown includes multiple locking positions as
shown in FIGS. 5B-C. Thus, the fastener 102 can snap into two
separate locked positions. The locking element 108 of the fastener
102 includes teeth 152 and receivers 158 to allow the cooperating
parts 122a and 122b to snap together. When the cooperating parts
122a and 122b are snapped together, the biological soft tissue is
engaged and locked so that it is held securely between the
cooperating parts 122a and 122b.
[0086] Once the fastener 102 is engaged and locked, tension on the
biological soft tissue can be relieved such that the soft tissue
begins to retract. The hook 118 of the anchor 104 is configured to
engage a second biological soft tissue or bone in order to create
tension on and secure the first or damaged biological soft tissue.
With reference to the biceps tendon 10, the hook 118 would engage
the transverse ligament (not shown) or sheath 22 after the implant
is secured to the tendon 10 in order to prevent a Popeye Sign. This
engagement of the hook 118 with the sheath 22 can be similar to the
engagement described above with reference to FIGS. 2A and 2B or the
hook 118 can engage an interior of the sheath in order to prevent a
Popeye Sign.
[0087] FIGS. 6A-D illustrate an alternate embodiment of the implant
of FIGS. 5A-E. FIGS. 6A-C illustrate perspective views of a
biological soft tissue implant 100 having a fastener 102 and anchor
104. The anchor 104 includes a hook 118. The fastener 102 includes
cooperating parts 122a and 122b, which are snapably engageable
opposing parts having gripping surfaces 156a and 156b with holes
114 on the gripping surfaces 156a. FIG. 6D is an elevation view of
the cooperating parts 122a and 122b. The fastener 102 can be
described as including both an engaging element 106 and a locking
element 108. The engaging element 106 of the fastener 102 includes
the cooperating parts 122a and 122b for trapping the biological
soft tissue, the spikes 112 and the gripping surfaces 156a and
156b, as well as the holes 114. The spikes 112 may be configured
with, for example, pyramidal tips as shown to facilitate
penetration of the spikes 112 through biological soft tissue. The
locking element 108 of the fastener 102 includes snap-fitting parts
120. In use, the implant 100 of FIGS. 6A-D is similar to that of
the implant of FIGS. 5A-E.
[0088] FIGS. 7A-J an embodiment of a biological soft tissue implant
100 having cooperating parts 122a and 122b that are slidably
engageable parts. FIGS. 7A-C illustrate perspective views of the
cooperating parts 122a and 122b at different positions of
engagement. FIGS. 7D-E illustrate perspective views of the
cooperating part 122a and FIGS. 7F-G illustrate perspective views
of the cooperating part 122b. FIGS. 7H-J illustrate elevation views
of the implant 100 engaging a biological soft tissue, such as a
biceps tendon 10.
[0089] FIGS. 7A-J illustrate a biological soft tissue implant 100
having a fastener 102 and anchor 104. The anchor 104 includes a
hook 118. The fastener 102 includes cooperating parts 122a and 122b
that are slidably engageable opposing parts. The cooperating parts
122a and 122b have gripping surfaces 156a and 156b and the gripping
surface 156a has slots 130. The fastener 102 can be described as
including both an engaging element 106 and a locking element 108.
The engaging element 106 includes the cooperating parts 122a and
122b for trapping the biological soft tissue, the gripping teeth
152 and the gripping surface 156 with slots 130. The locking
element 108 includes snap-fitting parts 120, which includes teeth
152 and receivers 158.
[0090] As shown in FIGS. 7H-J, the fastener 102 engages the
biological soft tissue, such as biceps tendon 10. First, the
biological soft tissue 10 is placed in an aperture 160 of the
cooperating parts 122b as shown in FIG. 7H. The cooperating parts
122a and 122b are then engaged as shown in FIG. 7I to engage and
lock the biological soft tissue. When the cooperating parts 122a
and 122b are brought together with the soft tissue 10 therebetween,
the fastener 102 engages the biological soft tissue 10.
Specifically, the gripping teeth 152 of the fastener 102 engage the
soft tissue 10 as the cooperating parts 122a and 122b are slidably
engaged. In addition, the gripping surface 156 and slots 130 help
to engage the biological soft tissue 10.
[0091] Once engaged, the fastener 102 also includes a locking
element 108. The locking element in the specific embodiment shown
includes multiple locking positions as shown in FIGS. 7B-C. Thus,
the fastener 102 can lock into multiple separate positions. The
locking element 108 of the fastener 102 includes a protrusion, or
teeth 152 and receivers 158 to allow the cooperating parts 122a and
122b to lock together after being slidably engaged. When the
cooperating parts 122a and 122b are locked together, the biological
soft tissue 10 is engaged and locked so that it is held securely
between the cooperating parts 122a and 122b. As shown in FIG. 7J,
tension on one side of the biological soft tissue 10 may be
relieved such as by resection or severing the tissue 10 following
engagement.
[0092] FIGS. 8A-I illustrate another embodiment of a biological
soft tissue implant 100 of FIGS. 7A-J. FIGS. 8A-C illustrate
perspective views of the cooperating parts 122a and 122b at
different positions of engagement. FIGS. 8D-E illustrate
perspective views of the cooperating part 122a and FIGS. 8F-G
illustrate perspective views of the cooperating part 122b. FIG. 8H
is another perspective view of the implant 100 illustrating the
anchor 104 and FIG. 8I is a plan view of the implant 100 as it
might look inside a cannula. Preferably, the embodiments of FIGS.
7A-J and 8A-I are capable of being used for arthroscopic procedures
and fit within the diameter of a cannula.
[0093] The implant 100 of FIGS. 8A-I is used in a manner similar to
the implant 100 of FIGS. 7A-J and is similar in design and
structure. The implant 100 of FIGS. 8A-J does not include slots 130
in a gripping surface 156. Also, the implant of FIGS. 8A-J includes
larger and wider snap-fitting parts 120, both the tooth 152 and
receivers 158. The fastener 102 includes cooperating parts 122a and
122b that are slidably engageable. The cooperating parts 122a and
122b have gripping surfaces 156a and 156b, respectively. The
fastener 102 can be described as including both an engaging element
106 and a locking element 108. The engaging element 106 includes
the cooperating parts 122a and 122b for trapping the biological
soft tissue, the gripping teeth 152 and the gripping surface 156.
The locking element 108 includes snap-fitting parts 120, which
includes teeth 152 and receivers 158.
[0094] FIGS. 9A-G illustrate one of the toggle embodiments of the
present invention. FIGS. 9A-D illustrate perspective view of the
implant 100 in an open position and in three locked positions.
FIGS. 9E-F illustrate perspective views of cooperating parts 122a
and 122b, respectively. FIG. 9G illustrates a perspective view of
the reverse side of the implant. As can be seen in FIG. 9A, this
toggle embodiment includes an implant 100 having a fastener 102 and
an anchor 104. The anchor 104 includes a pointed end 124 configured
to anchor when the implant 100 toggles, as explained below. The
fastener 102 includes cooperating parts 122a and 122b that are
snapably engageable. The cooperating parts 122a and 122b have
gripping surfaces 156a and 156b, respectively. In addition, the
gripping surface 156b has holes 114. The fastener 102 can be
described as including both an engaging element 106 and a locking
element 108. The engaging element 106 includes the cooperating
parts 122a and 122b for trapping the biological soft tissue, the
spikes 112, the gripping surfaces 156a and 156b and holes 114. The
locking element 108 includes snap-fitting parts 120, which include
teeth 152 and receivers 158. The snap-fitting parts 120 may include
tabs having teeth or pawls as shown or any other conventional
snap-fitting part that locks in place. Accordingly, the receivers
158 can be slots, holes, troughs, depressions or the like. The
locking element 108 includes multiple locking positions as shown in
FIGS. 9B-D. Thus, the fastener 102 can lock into three separate
positions.
[0095] In use, the cooperating parts 122a and 122b, which are
snapably engageable parts, trap the biological soft tissue. The
spikes 112 are inserted through the biological soft tissue and into
the corresponding holes 114 while the snap-fitting parts 120 are
engaged and locked in place. In this manner, the spike/aperture
engaging elements attach the fastener 102 to the tendon 10 while
the snap-fitting locking parts 120 of the locking element 108 lock
the implant 100 on the biological soft tissue.
[0096] While the fastener 102 is being attached to the tendon 10,
the tendon 10 is preferably either still at least partially
connected to the glenoid or if severed, is being held in place by
the surgeon. Once the implant 100 is attached, the tendon 10 is
released from the glenoid (if not previously severed) and the
length of the tendon 10 that is located proximal to the implant 100
is resected. The implant 100 is then allowed to travel down so that
the pointed end 124 of the anchor 104 engages with an inner surface
of the sheath 22. Typically, the severed tendon will naturally be
pulled down by the biceps muscle 16. The force of the biceps muscle
16 pulling on the severed tendon 10 operates to cause the implant
100 to rotate or toggle so that with increased tension, the pointed
end 124 will become securely engaged with the inner surface of the
sheath 22, and with an increase in tension, the tendon 10 will
become even more securely engaged. In other words, as tension
increases on the implant 100, the pointed end 124 will rotate in an
upwards motion and push or dig further into the sheath 22 making a
secure anchoring of the implant 100 in order to prevent a Popeye
Sign.
[0097] FIGS. 10A-G illustrate an alternative embodiment of the
implant of FIGS. 9A-G. FIGS. 10A-G illustrate one of the toggle
embodiments of the present invention. FIGS. 10A-D illustrate
perspective views of the implant 100 in an open position and in
three locked positions. FIGS. 10E-F illustrate perspective views of
cooperating parts 122a and 122b, respectively. FIG. 10G illustrates
a perspective view of the reverse side of the implant. The implant
100 of FIGS. 10A-G is used just as the implant of FIGS. 9A-G and is
similar in design and structure, except that the snap-fitting parts
120 of the implant of FIGS. 10A-G are different than those of the
implant of FIGS. 9A-G. In this embodiment, the snap-fitting parts
120 also include teeth 152 that engage a retaining surface 154,
rather than the holes or slots of FIGS. 9A-G. The locking element
108 includes multiple locking positions as shown in FIGS.
10B-D.
[0098] FIGS. 11A-G and 12A-F illustrate additional alternative
embodiments of the implant of FIGS. 9A-G. The implants 100 of 11A-G
and 12A-F are used just as the implant of FIGS. 9A-G and are
similar in design and structure. The anchor 104 includes a pointed
end 124 configured to anchor when the implant 100 toggles. The
fastener 102 includes parts 122a and 122b that are snapably
engageable and have gripping surfaces 156a and 156b with ridges 126
on the gripping surfaces 156a and 156b. For FIGS. 11A-G, the ridges
126 run vertically, whereas in FIGS. 12A-F, the ridges 126 run
horizontally. The fastener 102 can be described as including both
an engaging element 106 and a locking element 108. The engaging
element 106 includes the cooperating parts 122a and 122b for
trapping the biological soft tissue and the gripping surfaces 156a
and 156b with ridges 126. The locking element 108 includes
snap-fitting parts 120, which include pins 162 and receivers 158.
FIGS. 11A-G and FIGS. 12A-F include a locking element 108 that has
multiple locking positions.
[0099] FIGS. 13A-G illustrate another alternative embodiment of the
implant of FIGS. 9A-G. The implant 100 of FIGS. 13A-G is used just
as the implant 100 of FIGS. 11A-G and is similar in design and
structure. In this embodiment, the engaging element 106 of the
fastener 102 includes a gripping beam 128 as well as a single
vertical ridge 126.
[0100] FIGS. 14A-C and 15A-D all illustrate alternative clip
embodiments of the present invention. Each of the embodiments
includes cooperating parts 122a and 122b that are snapably
engageable. Each of the embodiments also includes an implant 100
having a fastener 102 and anchor 104. The anchor 104 includes a
hook 118 in FIGS. 14A-C, and FIG. 15B. FIG. 15A illustrates a flap
116 and FIGS. 15C-D can have either a hook 118 or flap 116. The
fasteners 102 include cooperating parts 122a and 122b that are
snapably engageable and include gripping surfaces 156a and 156b,
respectively. The fastener 102 can be described as including both
an engaging element 106 and a locking element 108. The engaging
element 106 includes the cooperating parts 122a and 122b for
trapping the biological soft tissue, and the gripping surface 156.
For FIGS. 14A-C, the engaging element also includes slots 130. For
FIG. 15C, the engaging element also includes spikes 112. The
locking element 108 includes snap-fitting parts 120.
[0101] FIGS. 16A-B are two similar embodiments of living hinge
embodiments of the present invention. Each of the embodiments
includes cooperating parts 122a and 122b that are snapably
engageable and separated by at least one living hinge 200. Each of
the embodiments also includes an implant 100 having a fastener 102
and anchor 104. The anchor 104 includes a flap 116 or hook 118. The
fasteners 102 include cooperating parts 122a and 122b having a
gripping surfaces 156a and 156b, respectively. The fastener 102 can
be described as including both an engaging element 106 and a
locking element 108. The engaging element 106 includes the
cooperating parts 122a and 122b for trapping the biological soft
tissue, gripping surfaces 156a and 156b, and spikes 112. The
locking element 108 includes snap-fitting parts 120 that allow the
implant 100 to have two locking positions.
[0102] FIG. 17A shows another embodiment of an implant 100
according to the present invention that is attached to a damaged
biological soft tissue 10. The implant 100 is configured such that
once the damaged biologic soft tissue 10 is severed, as shown in
FIG. 17B, the implant 100 interacts with a second biological soft
tissue (or a bone) to prevent the severed biologic soft tissue 10
from retracting beyond a predetermined position. In the specific
example of FIGS. 17A-B, the tendon 10 is severed at the glenoid,
such as during a tenotomy. Without the aid of the implant 100 of
the present invention, the tendon 10 may retract down through the
bicipital sheath 22. This causes what is known as the Popeye Sign
condition, as described above.
[0103] If the implant 100 is attached to the biceps tendon 10 prior
to severing the tendon 10, however, the implant 100 will interact
with the bony bicipital groove 18 and the tissue of the bicipital
sheath 22, thereby capturing the biceps tendon 10 within the
bicipital groove 18 and causing tension on the tendon 10 between
the implant 100 and the bicep 16. This prevents the tendon 10 from
retracting beyond a predetermined position. This predetermined
position may be any position that prevents an undesired effect
associated with severing the biological soft tissue, such as a
Popeye Sign. After capturing the tendon 10, the implant 100 places
tension on one side of the biological soft tissue that is less than
the tension placed on the biological soft tissue on the other side
of the biological soft tissue implant 100. Moreover, any retraction
of the first biological tissue further increases the interaction of
the biological soft tissue implant 100 with the second biological
soft tissue or the bony tissue. In other words, as the first
biological tissue retracts, the implant 100 strengthens its
connection or attachment with or to the second biological
tissue.
[0104] It should be noted that the bicipital sheath 22 boundaries
include the transverse ligament and the bony bicipital groove 18.
Therefore, the implant 100 may be configured so that it is of a
greater size in one dimension than in another (i.e. it is in a
shape other than round). Thus, when the implant 100 engages the
bicipital groove 18, it may tend to self-align by action of the
bicipital groove 18, and thus engage the boundaries of the sheath
22. Thus, fixation of the implant 100 may be achieved by engagement
with the tunnel bounded by the bicipital sheath 22 and the bony
bicipital groove 18.
[0105] FIG. 18 illustrates the specific embodiment of the implant
of FIGS. 17A-B. The implant 100 includes a fastener 102 and anchor
104. The anchor 104 is a series of spikes 112. The fastener 102 of
the implant 100 is attached to the biceps tendon 10 as described
above. The fastener 102 includes a retaining ring 110 with spikes
112 and a gripping surface 156. The retaining ring 110 of the
fastener 102 is placed about the tendon 10 and squeezed or crimped
to engage the biological soft tissue so that the spikes 112 are
forced to engage the biological soft tissue and further secure the
fastener 102 with the biological soft tissue. The spikes 112 may be
forced into the biological soft tissue or even penetrate through
the biological soft tissue to provide a secure connection or
anchorage of the implant 100.
[0106] FIGS. 19A-B illustrate another alternative embodiment of the
implant 100 alone and attached to a biological soft tissue. The
implant 100 is similar to that of FIG. 18A except that the fastener
102 and anchor 104 each include barbs 132 instead of spikes
112.
[0107] FIGS. 20A-B illustrate another alternative embodiment of the
implant alone and attached to a biological soft tissue. The implant
100 is similar to that of FIG. 19-A-B except that the retaining
ring includes interdigitating teeth 152 along the seam of the
retaining ring 110.
[0108] FIGS. 21A-D illustrate a "tether" approach according to the
present invention, wherein a suture loop 136 is disposed through
the biceps tendon 10. Like the other approach, the implant 100 is
configured to be pulled down and engage biological soft tissue as
shown in FIG. 21B. A "banjo-style" implant 100 can be threaded onto
the two free ends of the suture loop 136, as shown in FIG. 21C. The
implant 100 is approximated to the tendon 10, as shown in FIG. 21D,
after which the tendon 10 is permitted to retract into the
bicipital sheath 22, as shown in FIG. 21B. The implant 100 engages
bicipital groove 18 and bicipital sheath 22, thus preventing
further retraction of the tendon 10.
[0109] The embodiment illustrated in FIGS. 22A-D is similar in some
respects to that shown in FIGS. 21A-D. Provided is an inflatable
balloon implant 100, having a structure similar to that of an
inflatable stent and functions in accordance with the principles of
the invention, in a manner similar to the implant shown in FIGS.
21A-D. More particularly, referring to FIG. 22C, a suture loop 136
is placed in the tendon 10, and the implant 100 is threaded over
the free ends of the suture loop 136. Then, as shown in FIG. 22D,
the implant 100 is approximated to the tendon 10, and inflated to
expanded size. Then, as shown in FIG. 22B, the tendon 10 is
separated from the glenoid and permitted to retract downwardly into
the sheath 22. As in the previous embodiment, however, the implant
100 becomes engaged in the bicipital groove 18, and fixed in
position, thereby maintaining the attached tendon 10 in a fixed
position as well. Thus, further retraction of the biceps tendon 10,
and the resultant undesirable effects, are avoided. Alternatively,
the tendon may be detached from the glenoid before the implant 100
is sutured to the tendon 10, if desired, as long as the tendon 10
is held in its extended position sufficiently long to permit the
suturing and inflation steps to be completed, before retraction
into the bicipital groove 18 and bicipital sheath 22.
[0110] FIGS. 23A-C illustrate an embodiment of a biological soft
tissue implant 100 cooperating parts 122a and 122b that are
biasedly engageable. FIGS. 23A-B show top and bottom perspective
views of the implant 100 and FIG. 23C shows the implant 100 as it
may appear within the diameter of a cannula. Illustrated is a
biological soft tissue implant 100 having a fastener 102 and anchor
104. The anchor 104 includes tabs 116. The fastener 102 includes
cooperating parts 122a and 122b having a gripping surfaces 156a and
156b, respectively, on their interiors. The implant 100 may also
include teeth for engaging the implant.
[0111] In operation, the implant 100 may be located at the
biological soft tissue, such as by being passed through a cannula
as shown in FIG. 24C. Once the implant 100 is located at the
tissue, the normally closed cooperating parts 122a and 122b are
opened by applying pressure to the tabs 116. The biological soft
tissue is then located inside the implant 100 and the pressure
being applied to the tabs 116 is relieved. The cooperating parts
122a and 122b then clamp onto the biological soft tissue. Once the
biological soft tissue is severed, the tabs 116 act as an anchor
104 to prevent the biological soft tissue from retracting beyond a
suitable point.
[0112] FIGS. 24A-D illustrate another embodiment of a slidably
engageable implant 100 with a hook and capture mechanism. FIGS.
24A-B illustrate perspective views of the implant 100 in both open
and close positions, respectively. FIGS. 24C-D illustrate
perspective views of cooperating parts 122a and 122b, respectively.
Illustrated is a biological soft tissue implant 100 having a
fastener 102 and anchor 104. The anchor 104 includes a hook 118.
The fastener 102 includes cooperating parts 122a and 122b that are
slidably engageable. The implant 100 includes a hook and capture
mechanism for capturing the biological soft tissue. The fastener
102 can be described as including both an engaging element 106 and
a locking element 108. The engaging element 106 includes the
cooperating parts 122a and 122b for trapping the biological soft
tissue, as well as the hook and capture mechanism. The locking
element 108 may employ snap-fitting parts (not shown) to hold the
cooperating parts 122a and 122b together.
[0113] In operation the fastener 102 engages the biological soft
tissue between the cooperating parts 122a and 122b. When the
cooperating parts 122a and 122b are brought together with the soft
tissue therebetween, the fastener 102 engages the biological soft
tissue. Specifically, the hook captures the biological soft tissue
and traps it once the cooperating parts 122a and 122b are brought
together. Once engaged, the fastener 102 also includes a locking
element 108. Once the fastener 102 is engaged and locked, tension
on the biological soft tissue can be relieved such that the soft
tissue begins to retract. The hook 118 of the anchor 104 is
configured to engage a second biological soft tissue or bone in
order to create tension on and secure the first or damaged
biological soft tissue. With reference to the biceps tendon 10, the
hook 118 would engage the transverse ligament (not shown) or sheath
22 after the implant 100 is secured to the tendon 10 in order to
prevent a Popeye Sign. This engagement of the hook 118 with the
sheath 22 can be similar to the engagement described above with
reference to FIGS. 2A and 2B or the hook 118 can engage an interior
of the sheath 22 in order to prevent a Popeye Sign.
[0114] FIGS. 25A-D illustrate an embodiment of a biological soft
tissue implant having a suture wrapped around the implant 100 and
biological soft tissue. FIG. 25A illustrates a perspective view of
the implant 100 without the suture. FIGS. 25B-D illustrate top,
side and bottom elevation views, respectively, of the implant 100
and suture in combination 150. Illustrated is a biological soft
tissue implant 100 having a fastener 102 and anchor 104. The anchor
104 includes a hook 118. The fastener 102 includes a retaining ring
110 in combination with a suture 150, as well as knots 148 or beads
or ratchet mechanism (not shown) such as that found on a common
cable tie. The fastener 102 can be described as including both an
engaging element 106 and a locking element 108. The engaging
element 106 includes retaining ring 110 having a gripping surface
156 with slots 130 in combination with a suture 150. The locking
element 108 may include knots 148, beads or ratchet mechanism (not
shown).
[0115] In operation the suture 150 is preferably wrapped around the
ring 110 during manufacture and a hook-shaped probe is used to pull
the biological soft tissue into the retaining ring 110. The
biological soft tissue may be doubled within the ring 110. Tension
is then applied to the suture 150 to cinch the biological soft
tissue against the inner wall or gripping surface 156 of the ring
110. The suture may then be locked in place using a locking element
such as those described above. The hook 118 of the anchor 104 is
configured to engage a second biological soft tissue or bone in
order to create tension on and secure the first or damaged
biological soft tissue.
[0116] FIGS. 26A-B illustrate perspective views of open and closed
configurations of an embodiment of a biological soft tissue implant
100 having cooperating parts 122a and 122b that are snapably
engageable. Illustrated is a biological soft tissue implant 100
having a fastener 102 and anchor 104. The anchor 104 includes barbs
132. The fastener 102 includes cooperating parts 122a and 122b
having a gripping surfaces 156a and 156b, respectively. The
gripping surface 156a includes holes 114. The fastener 102 can be
described as including both an engaging element 106 and a locking
element 108. The engaging element 106 includes the cooperating
parts 122a and 122b for trapping the biological soft tissue, the
spikes 112 and the gripping surface 156a and 156b with holes 114.
The locking element 108 includes snap-fitting parts 120.
[0117] FIG. 27 illustrates an embodiment of a biological soft
tissue implant 100 having a retaining ring 110. The implant 100
includes cooperating parts 122a and 122b that are hookably or
snapably engageable. The cooperating parts 122a and 122b have a
gripping surfaces 156a and 156b, respectively. The implant further
includes spikes 112 on the gripping surface 156, and a hinge 200
connecting the cooperating parts 122a and 122b on one end, with a
latch locking or snapping the cooperating parts 122a and 122b
together. When connected, the cooperating parts 122a and 122b form
a retaining ring 110. The engaging element 106 includes the
cooperating parts 122a and 122b for trapping the biological soft
tissue, the spikes 112 and the gripping surfaces 156a and 156b. The
locking element 108 includes snap-fitting parts 120.
[0118] FIG. 28 shows another alternative embodiment of the implant
100 comprising an implant 100 with a retaining ring 110 and two
laterally extending beams with hooks 118. The implant has a
fastener 102 and anchor 104. The anchor 104 includes beams with
hooks 118. The fastener 102 includes a retaining ring 110 with a
gripping surface 156 where the retaining ring can be crimped around
the biological soft tissue. The fastener 102 can be described as
including both an engaging element 106 and a locking element 108.
The engaging element 106 includes the retaining ring 110 and
gripping surface 156 while the locking element may include
crimping.
[0119] FIGS. 29-30 show alternative embodiments of the implant 100
comprising cooperating parts 122a and 122b that are biasedly
engageable. The implant 100 has a fastener 102 and anchor 104. The
anchor 104 includes tabs 116. The fastener includes biasedly
engageable cooperating parts 122a and 122b having gripping surfaces
156a and 156b, respectively, and teeth 152.
[0120] In operation, the implant 100 may be placed on the
biological soft tissue after being passed through a cannula, which
are commonly used during arthroscopic procedures. Once the implant
100 is located at the tissue, the normally closed cooperating parts
122a and 122b are opened by applying pressure to the tabs 116. The
biological soft tissue is then located inside the implant 100 and
the pressure being applied to the tabs 116 is removed. The
cooperating parts 122a and 122b, with gripping surfaces 156a and
156b and teeth 152 then clamp onto the biological soft tissue. Once
the biological soft tissue is severed, the tabs 116 act as an
anchor 104 to prevent the biological soft tissue from retracting
beyond a suitable point.
[0121] FIGS. 31A-E show an alternative embodiment of the implant
100 comprising cooperating parts 122a and 122b that are biasedly
engageable. The implant 100 further includes a hook and capture
mechanism. The implant 100 has a fastener 102 that includes a body
164 and normally closed retaining clip 166. The retaining clip 166
traps the biological soft tissue between the body 164 and retaining
clip 166.
[0122] It should be noted that, while the devices disclosed in the
present application have been discussed in connection with biceps
tendon treatment procedures, they could be extended to other
applications, other types of tendon treatment, soft tissue to soft
tissue treatment, fixation of soft tissue to another soft tissue,
and tendon fixation, for example. Thus, all of the terms used
herein are descriptive rather than limiting, and many changes,
modifications, and substitutions may be made by one having ordinary
skill in the art without departing from the spirit and scope of the
invention. Moreover, while the present invention has been described
in association with several exemplary embodiments, the described
embodiments are to be considered in all respects as illustrative
and not restrictive. Such other features, aspects, variations,
modifications, and substitution of equivalents may be made without
departing from the spirit and scope of this invention which is
intended to be limited solely by the scope of the following claims.
Also, it will be appreciated that features and parts illustrated in
one embodiment may be used, or may be applicable, in the same or in
a similar way in other embodiments.
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