U.S. patent application number 13/010777 was filed with the patent office on 2011-07-21 for tissue repair implant and delivery device and method.
Invention is credited to Michael P. Whitman.
Application Number | 20110178537 13/010777 |
Document ID | / |
Family ID | 44278090 |
Filed Date | 2011-07-21 |
United States Patent
Application |
20110178537 |
Kind Code |
A1 |
Whitman; Michael P. |
July 21, 2011 |
TISSUE REPAIR IMPLANT AND DELIVERY DEVICE AND METHOD
Abstract
A device having an implant driver configured to anchor a first
implant to a first portion of tissue and to anchor a second implant
to a second portion of tissue, the first and second anchors being
coupled to respective first and second sutures, and a winder
configured to twist the first and second sutures together as the
sutures are refracted, thereby bringing the first portion of tissue
into approximation with the second portion of tissue.
Inventors: |
Whitman; Michael P.; (New
Hope, PA) |
Family ID: |
44278090 |
Appl. No.: |
13/010777 |
Filed: |
January 20, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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61296868 |
Jan 20, 2010 |
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Current U.S.
Class: |
606/144 |
Current CPC
Class: |
A61B 2017/0435 20130101;
A61B 2017/0408 20130101; A61B 2017/0647 20130101; A61B 2017/081
20130101; A61B 2017/0427 20130101; A61B 2017/0437 20130101; A61B
2017/0648 20130101; A61B 17/10 20130101; A61B 2017/00575 20130101;
A61B 2017/0464 20130101; A61B 2017/0414 20130101; A61B 17/0057
20130101; A61B 2017/0412 20130101; A61B 2017/00579 20130101; A61B
2017/0488 20130101; A61B 17/0487 20130101; A61B 2017/00632
20130101; A61B 17/0401 20130101 |
Class at
Publication: |
606/144 |
International
Class: |
A61B 17/04 20060101
A61B017/04 |
Claims
1. A surgical device, comprising: a first anchor coupled to a first
suture; a second anchor coupled to a second suture; an implant
driver configured to anchor a first implant to a first portion of
tissue and to anchor a second implant to a second portion of
tissue, the first and second anchors being coupled to respective
first and second sutures; and a winder configured to twist the
first and second sutures together bringing the first portion of
tissue into approximation with the second portion of tissue.
2. The device of claim 1, wherein the implant driver is configured
to anchor the implants by using a hydraulic driver.
3. The device of claim 2, wherein the hydraulic driver uses saline
as a hydraulic fluid.
4. The device of claim 1, further comprising clamping element
configured to clamp together the sutures after the winding.
5. The device of claim 4, wherein the clamping element is further
configured to trim the an excess length of each suture disposed
proximally to a location of the clamping.
6. The surgical device of claim 1, wherein the first implant is a
fastener having a plurality of anchoring filaments configured to
resist refraction of the fastener from the first portion of
tissue.
7. The surgical device of claim 1, wherein the first implant is a
fastener having a plurality of wings configured to resist
retraction of the fastener from the first portion of tissue.
8. The surgical device of claim 1, wherein the first implant is a
self-expanding anchor.
9. The surgical device of claim 8, wherein the first implant is
disk-shaped.
10. The surgical device of claim 9, wherein the self-expanding
anchor includes a plurality of tissue-piercing teeth configured to
penetrate the entire thickness of the first portion of tissue.
11. A surgical device, comprising: a hollow needle having an inner
chamber and a sharp tip configured to pierce a tissue; a first
self-expanding anchor having a collapsed position and an expanded
position, the first anchor being positionable within the inner
chamber when in the collapsed position; a first suture extending
through the needle and attached to the first anchor; and an
actuator configured to drive the needle containing the first anchor
into a first predetermined position in a first portion of tissue,
wherein the needle is retractable from the first predetermined
position to leave the first anchor in the first predetermined
position, and the first anchor is expandable from the collapsed
position to the expanded position upon retraction of the
needle.
12. The device of claim 11, further comprising: a second
self-expanding anchor having a collapsed position and an expanded
position, the second self-expanding anchor being positionable
within the inner chamber when the second self-expanding anchor is
in the collapsed position; and a second suture extending through
the needle and attached to the first anchor, wherein the actuator
is configured to drive the needle with the second anchor into a
second predetermined position in a second portion of the tissue,
the needle being retractable from the second predetermined position
to leave the second anchor in a position distally beyond the second
portion of tissue, and the second anchor is expandable from the
collapsed position to the expanded position upon retraction of the
needle.
13. The device of claim 12, wherein each of the first and second
sutures is a braided suture.
14. The device of claim 12, wherein the device includes an actuator
configured to distally retract the first suture and the second
suture into a distal end of the device, thereby pulling the first
anchor and the second anchor together, the pulling of the first
anchor and the second anchor together causing the first portion of
tissue to be pulled toward the second portion of tissue.
15. The device of claim 14, wherein the sutures are twisted as they
are distally retracted.
16. The device of claim 14, further comprising a clamp configured
to join the first suture to the second suture and cut excess
portions of the first suture and the second suture distal to the
joint of the first suture to the second suture.
17. A surgical system, comprising: a first implant coupled to a
first suture; a second implant coupled to a second suture; and an
implant driver configured to position the first implant in a first
predetermined position in relation to a first tissue, and to
position the second implant in a second predetermined position in
relation to a second tissue, the implant driver configured to draw
the first and second sutures together to bring the implants into
apposition thereby bringing the first tissue and the second tissue
into apposition, wherein the first and second implants are
configured to pierce both the first and second tissues at an
interface of the first and second tissues when the first and second
tissues are in apposition.
18. The system of claim 17, wherein the first implant is a first
disk and the second implant is a second disk.
19. The system of claim 18, wherein the first disk includes a
plurality of projections each configured to cut entirely through
the first tissue and the second disk includes a plurality of
projections each configured to cut entirely through the second
tissue.
20. A method, comprising: positioning a first implant in a first
predetermined position adjacent a first tissue; positioning a
second implant in a second predetermined position adjacent a second
tissue; bringing the first and second tissues into apposition by
pulling the first and second implants into apposition with each
other; and creating multiple puncture wounds in each of the first
and second tissues with the first and second implants.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. Provisional
Patent Application Ser. No. 61/296,868, filed on Jan. 20, 2010,
which is expressly incorporated herein in its entirety by reference
thereto.
[0002] Further, each of the following is hereby incorporated in its
entirety by reference thereto: U.S. patent application Ser. No.
______, Attorney Docket No. 14895/3, filed on Jan. 20, 2011, U.S.
patent application Ser. No. ______, Attorney Docket No. 14895/5,
filed on Jan. 20, 2011; and U.S. patent application Ser. No.
______, Attorney Docket No. 14895/6, filed on Jan. 20, 2011.
FIELD OF THE INVENTION
[0003] The present invention relates to a tissue implant and
delivery device and method.
BACKGROUND INFORMATION
[0004] Some surgical interventions require the approximation of a
first tissue and a second tissue. Known devices for drawing two
tissues toward each other require instrument access to the outer
surfaces of the tissues being brought toward each other. For
example, where the two tissues are part of the same organ, these
instruments require access from the outside of an organ where the
tissues are part of the same organ. This may lead to trauma to
surrounding tissues and increase the risk of infection. Thus, there
is a need for a less invasive device and method for approximating
two tissues.
[0005] Moreover, there is a need for a tissue approximation
mechanism and method that is simple to operate and only requires
access to the space between the tissues being approximated.
Further, there is a need for a reliable tissue approximating
mechanism that may be precisely implemented.
[0006] Further, there is a need for a mechanism and method that
reduces procedural costs and allows access to difficult-to-reach
locations of the anatomy.
SUMMARY
[0007] According to example embodiments of the present invention, a
surgical device comprises an implant driver configured to anchor a
first implant to a first portion of tissue and to anchor a second
implant to a second portion of tissue, the first and second anchors
being coupled to respective first and second sutures, and a winder
configured to twist the first and second sutures together as the
sutures are retracted, thereby bringing the first portion of tissue
into approximation with the second portion of tissue.
[0008] The implant driver may be configured to anchor the implants
by using a hydraulic driver. The hydraulic driver may use saline as
a hydraulic fluid.
[0009] The device may further comprise a clamping element
configured to clamp together the sutures after the winding. The
clamping element may be further configured to trim the an excess
length of each suture disposed proximally to a location of the
clamping.
[0010] The first implant and/or second implant may be a fastener
having a plurality of anchoring filaments configured to resist
retraction of the fastener from the first portion of tissue.
[0011] At least one of the implants may be a fastener having a
plurality of wings configured to resist retraction of the fastener
from the first portion of tissue.
[0012] At least one of the implants may be a self-expanding
anchor.
[0013] At least one of the implants may be disk-shaped.
[0014] The self-expanding anchor may include a plurality of
tissue-piercing teeth configured to penetrate the entire thickness
of the first portion of tissue.
[0015] According to example embodiments of the present invention, a
surgical device comprises a hollow needle having an inner chamber
and a sharp tip configured to pierce a tissue, a first
self-expanding anchor having a collapsed position and an expanded
position, the first anchor being positionable within the inner
chamber when in the collapsed position, a first suture extending
through the needle and attached to the first anchor, and an
actuator configured to drive the needle containing the first anchor
into a first predetermined position in a first portion of tissue,
wherein the needle is retractable from the first predetermined
position to leave the first anchor in the first predetermined
position, the first anchor expanding from the collapsed position to
the expanded position upon retraction of the needle.
[0016] The device may further comprise a second self-expanding
anchor having a collapsed position and an expanded position, the
second self-expanding anchor being positionable within the inner
chamber when the second self-expanding anchor is in the collapsed
position, and a second suture extending through the needle and
attached to the first anchor, wherein the actuator is configured to
drive the needle with the second anchor into a second predetermined
position in a second portion of the tissue, the needle being
retractable from the second predetermined position to leave the
second anchor in a position distally beyond the second portion of
tissue, the second anchor expanding from the collapsed position to
the expanded position upon retraction of the needle. Each of the
first and second sutures may be a braided suture.
[0017] The device may include an actuator configured to distally
retract the first suture and the second suture into a distal end of
the device, thereby pulling the first anchor and the second anchor
together, the pulling of the first anchor and the second anchor
together causing the first portion of tissue to be pulled toward
the second portion of tissue.
[0018] The sutures may be twisted as they are distally
retracted.
[0019] The device may further comprise a clamp configured to join
the first suture to the second suture and cut excess portions of
the first suture and the second suture distal to the joint of the
first suture to the second suture.
[0020] According to example embodiments of the present invention, a
surgical system includes a first implant coupled to a first suture,
a second implant coupled to a second suture, and an implant driver
configured to position the first implant in a first predetermined
position in relation to a first tissue, and to position the second
implant in a second predetermined position in relation to a second
tissue, the implant driver configured to draw the sutures together
to bring the implants into apposition thereby bringing the first
tissue and the second tissue into apposition, wherein the implants
are configured to pierce both the first tissue and the second
tissue at an interface of the first and second tissues when the
first and second tissues are in apposition.
[0021] The first implant may be a first disk and the second implant
is a second disk.
[0022] The first disk may include a plurality of projections each
configured to cut entirely through the first tissue and the second
disk includes a plurality of projections each configured to cut
entirely through the second tissue.
[0023] According to example embodiments of the present invention, a
method comprises positioning a first implant in a first
predetermined position adjacent a first tissue, positioning a
second implant in a second predetermined position adjacent a second
tissue, bringing the first and second tissues into apposition by
pulling the first and second implants into apposition with each
other, and creating multiple puncture wounds in the first and
second tissues with the first and second implants to allow the
first and second tissues to heal together in the region of the
puncture wounds.
[0024] Further features and aspects of example embodiments of the
present invention are described in more detail below with reference
to the appended Figures.
BRIEF DESCRIPTION OF THE DRAWINGS
[0025] FIGS. 1A and 1B illustrate the insertion and manipulation of
a catheter into an organ.
[0026] FIGS. 2A and 2B illustrate a needle extending from the
catheter of FIGS. 1A and 1B and piercing a tissue wall of the
organ.
[0027] FIGS. 3A to 3C sequentially illustrate the opening of the
needle and deployment of a plate or implant from the needle.
[0028] FIGS. 4A to 4E sequentially illustrate the withdrawal of the
needle from the tissue wall and into the interior of the
catheter.
[0029] FIGS. 5A and 5B sequentially illustrate the re-maneuvering
of the catheter to a proximal position.
[0030] FIG. 6A illustrates the maneuvering of the catheter from the
proximal position to a second tissue wall of the organ.
[0031] FIG. 6B shows the piercing of the second tissue wall by the
needle and deployment of a second plate or implant.
[0032] FIG. 6C illustrates the retraction of the needle.
[0033] FIG. 7A illustrates the catheter after being maneuvered to
the proximal position.
[0034] FIGS. 7B and 7C sequentially illustrate the pulling together
of the two plates or implants.
[0035] FIGS. 7D and 7E sequentially illustrate the withdrawal of
the catheter from the organ.
[0036] FIGS. 8A to 8E sequentially illustrate the retraction and
twisting of respective lines or cords attached to each plate or
implant.
[0037] FIGS. 8F to 8G sequentially illustrate the clipping and
joining of the respective lines or cords attached to each plate or
implant.
[0038] FIG. 9 illustrates surgical implants with piercing
teeth.
[0039] FIG. 10A illustrates a surgical implant.
[0040] FIG. 10B is a cross-sectional view of the implant of FIG.
10A.
[0041] FIG. 10C is an illustration of a distal end portion the
surgical implant of FIG. 10A.
[0042] FIG. 11 illustrates a needle configured to carry an
anchoring fastener.
[0043] FIG. 12 illustrates a distal tip portion of an anchoring
fastener.
[0044] FIG. 13 illustrates an anchoring fastener with wings.
[0045] FIG. 14 is a schematic illustration of a surgical device to
approximate tissues with anchoring fasteners.
[0046] FIG. 15A illustrates the driving of an anchoring fastener
through a first tissue and into a second tissue using the device of
FIG. 14.
[0047] FIG. 15B illustrates the first and second tissues of FIG.
15A with the anchoring fastener implanted in the first tissue and
the suture attached to the anchoring fastener extending through the
first tissue.
[0048] FIG. 15C illustrates the first and second tissues of FIG.
15B with a second anchoring fastener driven through the second
tissue and into the first tissue and with the device twisting the
sutures attached to the anchoring fasteners.
[0049] FIGS. 15D to 15F sequentially illustrate the retraction,
twisting, and clamping of sutures attached to the anchoring
fasteners of FIG. 15C to join the two tissues.
[0050] FIG. 15G shows fasteners driven into the tissues at angles
and locations that differ from the procedure of FIGS. 15A to
15F.
DETAILED DESCRIPTION
[0051] FIGS. 1A to 8G illustrate an implant device or catheter 3000
that is maneuverable between two opposed layers 951 and 952 of
tissue 950 in order to close or narrow a gap or distance between
the opposed layers 951 and 952 of tissue 950. Referring to FIG. 1A,
the implant device 3000 is maneuvered between a first layer 951 of
tissue 950 and a second, opposed layer 952 of tissue 950. The
tissue may be, e.g., tissue of a stomach. As illustrated in FIG.
1B, the distal end of the housing 3001 of the catheter or implant
device 3000 is maneuvered to be in proximity or contact with and
directed toward the first layer 951 of tissue 950. The housing 3001
may be maneuvered by any appropriate mechanism, e.g., guide
wires.
[0052] After positioning and orienting the housing 3001, a
sharp-pointed implant-carrying needle or sleeve 3100 is distally
extended from the housing 3001 to pierce and penetrate the first
layer 951 of tissue 950, as illustrated, e.g., in FIGS. 2A and 2B.
The needle 3100 may be formed of, e.g., a shape-memory material,
e.g., nitinol or spring-loaded steel.
[0053] After the needle 3100 has pierced and extended a distance
beyond the first layer 951 of tissue 950, as illustrated in FIGS.
2A and 2B, the distal portion of the needle 3100 expands, or
flowers, outwardly, with four adjacent extensions or leaves 3105
separated by longitudinal slits therebetween, as illustrated, e.g,
in FIG. 3A. Although four extensions or leaves 3105 are provided,
it should be understood that any appropriate number may be
provided. Moreover, the distal end of the needle 3100 may have one
or more elastic portions that provide analogous expansion. It is
noted that the needle 2100 described above may have a structure
analogous to that of needle 3100 to allow for retraction of the
sleeve 2100.
[0054] When the leaves 3105 open or expand outwardly, a button-like
implant or plate 3200 is exposed from the interior of the needle
3100. The plate 3200, which is formed, e.g., from a shape memory
alloy such as, e.g., nitinol, or spring-loaded steel, springs from
a folded position that allows for storage inside the non-expanded
needle 3100, into a deployed or expanded position as sequentially
illustrated in FIGS. 3A to 3C.
[0055] Although the plate 3200 has a flattened, cylindrical shape,
it should be understood that the plate 3200 may be designed to have
any appropriate shape and/or size depending on, e.g., the
particular application.
[0056] After the plate 3200 is released and expanded, the needle
3100 proximally retracts back into the housing 3001, as
sequentially illustrated in FIGS. 4A to 4E. As the needle 3100
retracts, a cord 3300, e.g., a braided suture, which is attached to
the plate 3200 and extends into and through the needle 3100 is
exposed between the plate 3200 and the needle 3100. Further, as the
needle 3100 retracts, the cord 3300 is pulled distally to the
extent that the plate 3200 contacts an exterior or distal surface
of the first layer 951 of tissue 950, as illustrated, e.g., in FIG.
4C.
[0057] The cord 3300 is formed of a plurality of threads 3305,
e.g., absorbable or non-absorbable suture material, that extend
through various apertures in the plate 3200 in a button-like manner
to secure the cord to the plate 3200. It should be understood,
however, that the cord 3300 may be a single strand and/or attached
to the plate 3200 by any other appropriate mechanism.
[0058] FIGS. 5A and 5B sequentially illustrate the re-maneuvering
of the catheter to a proximal position, while allowing a
corresponding length of cord 3300 to be distally released from the
housing 3001.
[0059] FIG. 6A illustrates the maneuvering of the catheter from the
proximal position to a second wall or layer 952 of tissue 950 of
the organ, the second layer 952 being opposed and spaced apart from
the first layer 951 of tissue 950. FIG. 6B shows the piercing of
the second layer 952 by a needle 3100, which may be the same needle
3100 that pierced the first layer 951, or a second needle 3100
separate from the first needle 3100. FIG. 6B further shows the
deployment of a second button-like implant or plate 3200 on the
distal surface of the second layer 952 of tissue 950 in analogous
manner to the deployment of the first plate 3200 described
above.
[0060] As illustrated in FIG. 6C, the needle 3100 is then retracted
proximally into the housing 3001, which then returns to a proximal
position as illustrated in FIG. 7A, in analogous manner to that
described above, with a second cord 3300 being attached to the
second plate 3200.
[0061] FIGS. 7A to 7C sequentially illustrate the pulling together
of the two plates or implants 3200 by drawing the two cords 3300
proximally into the housing 3001, and joining and clipping the two
cords 3300. By drawing the two cords 3300 into the housing 3001,
the two plates 3200, each attached to a respective one of the cords
3300 are drawn together. As a result of the contact between the
proximal faces of the two plates 3200 and the respective distal
faces of the two opposed layers 951 and 952 of tissue 900, the
layers 951 and 952 of tissue 950 are drawn together, as
illustrated, e.g., in FIG. 7C. After joining and clipping of the
two cords 3300, the implanting device 3000 is retracted from the
surgical site, e.g., organ, as illustrated sequentially in FIGS. 7D
and 7E. Thus, the above procedure results in the implantation of
two opposed, button-like plates 3200 joined by cords 3300 to hold
two opposed layers 951 and 952 of tissue 950 in a drawn-together
position, as illustrated, e.g., in FIG. 7D.
[0062] FIGS. 8A to 8G sequentially illustrate the pulling and
clipping of the two cords 3300 by the implanting device 3000, which
is illustrated in cross section. Referring to FIG. 8A, the housing
3001 is in the proximal position corresponding to FIG. 7A. Each
cord 3300 extends into the distal opening of the housing 3001 and
along the length in the internal bore of the housing 3001. Each
cord also extends into a distal opening of a tubular sleeve 3400,
which is also disposed in the internal bore of the housing 3001. At
a distal end of the tubular sleeve 3400 are a pair of hooked
twisting arms 3405. As illustrated sequentially in FIGS. 8B to 8E,
the cords 3300 and the twisting arms 3405 are retracted proximally
with respect to the housing 3001, while the tubular sleeve 3400
rotates about its longitudinal axis. The rotation of the tubular
sleeve 3400 about its longitudinal axis causes the twisting arms
3405 to engage the respective cords 3300 and revolve around the
longitudinal axis of the tubular sleeve 3400. The continued
revolution of the twisting arms 3405 causes the engaged cords 3400
to be continually and progressively twisted as the cords 3300 and
the sleeve 3400 proximally retract, until the cords 3300 have
reached their desired end position and the respective plates 3200
have reached their desired approximation, as illustrated in FIG.
8E. It is noted that the degree of retraction of the cords 3300 may
be adjusted to achieve varying degrees of closure between the two
layers 951 and 952 of tissue 950. The hooked shape of the twisting
arms 3405 holds the cords a predetermined distance from the
longitudinal axis of the sleeve 3400. This allows for greater
control of the twisting of the cords 3300.
[0063] Although the tubular sleeve 3400 rotates about its
longitudinal axis with respect to the housing 3001 and the tissue
950, it should be understood that both the housing 3001 and the
sleeve 3400 may rotate with respect to the tissue 950. For example,
the sleeve 3400 may be non-rotatable, or substantially
non-rotatable, with respect to the housing 3001, with the sleeve
3400 proximally retracting with respect to the housing 3001 and the
tissue 950 as the sleeve 3400 and housing 3001 rotate together to
twist the cords 3300.
[0064] When the desired position of FIG. 8E is reached, the
respective cords 3300 are fastened together and trimmed by pair of
clip members 3500. The clip members 3500 are brought from an
initial position, illustrated, e.g., in FIG. 8E, into contact with
a distal portion of the twists of the cords 3300, as illustrated in
FIG. 8F. In order to join and trim the cords 3300, the clip members
3500 are further closed until they lock together and separate
distal implant portions 3305 of the cords 3300 from proximal excess
portions 3310 of the cords 3300. At this stage, the locked clip
members 3500 are released from the distal end of the implanting
device 3000, thereby separating and releasing the implanted
portions 3200, 3305, and 3500 from the implanting device 3000,
allowing retraction and removal of the implanting device 3000 from
the surgical site. Thus, the implanted portions are left in their
implanted position, maintaining the first and second layers 951 and
952 of tissue 950 in the desired approximation relative to each
other.
[0065] Although the clip members 3500 simultaneously join the
implanted portions 3305 of the cords 3300 and cut the excess
portions 3310 from the cords 3300 (e.g., by opposed cutting members
at proximal locations on the respective clip members 3500, which
come together to separate the excess portions 3310 as the implant
portions 3305 are fastened together), it should be understood that
the excess portions 3310 may be trimmed at a different time and/or
by a mechanism separate from the clip members 3500.
[0066] Further, although the implant portions 3305 are joined by
clamping and locking two opposed clip members 3500, it should be
understood that other joining mechanisms may be provided. For
example, where, e.g., the cords 3300 are made of polymeric
materials, the implant portions 3305 may be welded or melted
together, e.g., by application of heat, pressure, and/or
high-frequencies.
[0067] The use of the plates 3200 may be particularly suitable for
applications where a structure has a cavity on the distal or
opposite side of the layer 951 or 952. However, in other
applications, it may be preferable to replace one or more, e.g.,
all, of the plates 3200 with one of the anchoring fasteners, e.g.,
fasteners 250, 350, 550 described below. In this regard, the suture
3300 (e.g., a braided material) would be attached to the fastener
250, 350, 550, at the distal end thereof, as set forth in greater
detail below, and extend into the distal end of the housing, e.g.,
housing 3001, in the manner described above. The remaining
operation would be analogous to that described above with respect
to the plates 3200, with the sutures 3300 being retracted, joined,
and trimmed. However, one or more (e.g., all) of the tissue
portions would be pulled by the engagement of an anchoring fastener
(e.g., fastener 250 or 300), rather than the button-like plate
3200. The fastener may be deposited in any manner disclosed herein,
including, e.g., directly firing the fastener into the tissue or
insertion via a needle such as, e.g., the needle 2100. It should be
understood that more than two implants (e.g., plates 3200 and/or
fasteners, e.g., fasteners 250, 350) may be provided, with more
than two cords 3300 being retracted, twisted and joined.
[0068] The cords/sutures 3300, plates 3200, and/or clip members
3500 may be formed entirely or partly of a bioabsorbable material,
e.g., polyglycolic acid (PGA), or a PGA copolymer.
[0069] FIG. 9 illustrates a pair of piercing pledgets or implants
4200. The piercing implants may be provided in a surgical system
having all of the features described above with respect to the
surgical device 3000, with piercing implants or disks 4200 being
provided in place of the implants 3200. Although both implants 3200
have been replaced by implants 4200 it should be understood that
one piercing implant 4200 may be used in combination with an
implant 3200 described above.
[0070] As illustrated in FIG. 9, the implants 4200 have been
deployed and secured in the same manner described above with regard
to implants 3200. It is noted that implants 4200, like implants
3200 are self-expanding and may be deployed from the needle 3100.
For simplicity, the cords 3300 and clip elements 3500 are not shown
in FIG. 9.
[0071] The implants 4200 differ from the implants 3200 in that they
are each provided with a plurality of tissue-piercing teeth 4205
extending from the surface that contacts the respective layers of
tissue 951 and 952. These sharp pointed projections are
interspersed, e.g., according to a predetermined density per unit
area, over the tissue contacting face of each implant 4200. The
teeth 4205 have a length selected to fully penetrate the respective
layer of tissue 951, 952. That is, the teeth 4205 have a length
that allows the sharp tip to penetrate and extend beyond the
opposed face of the tissue, e.g., the interior surface of an organ
where the tissues 951 and 952 are opposed walls of the same organ.
This full penetration forms a wound that causes collagen to
naturally be produced from the tissue and flow, via the holes
formed by the teeth 4205, into the space between the two opposed
tissues 951 and 952. This is advantageous in that it facilitates
healing together of the two apposed tissues 951 and 952.
[0072] FIGS. 10A and 10B illustrate a surgical micro implant or
fastener 250 that may be used in connection with a surgical system
as described above. However, one or more of the disk-like implants
3200 and/or 4200 are replaced by implant 250. FIG. 10B is a
cross-sectional view of the surgical implant 250 of FIG. 10A with a
cross-sectional plane extending along and including the
longitudinal axis of the fastener 250 of FIG. 10A. The fastener 250
has the suture 3300 extending proximally from a proximal end 285 of
the fastener body 255. In this regard, when a driver fires the
fastener 250, e.g., by application a saline or other precise
hydraulic force or any other appropriate mechanism, the depth to
which the fastener 250 is driven is limited by the amount of slack
in the suture 3300. This may be accomplished by fixing a proximal
end and/or other proximal portion of the suture 3300 to a
structure, e.g., a fixed position within the driver device, with a
predetermined length and/or slack between the fixing location and
the fastener body 255.
[0073] Referring to the cross-sectional view of FIG. 10B, the
suture 3300 may extend longitudinally into an interior location 290
of the fastener body 255. An example manufacturing method may
include molding, coextruding, or otherwise forming the fastener
head 905 over the suture 3300. It should be appreciated however,
that any appropriate manufacturing method may be employed. Further,
although a suture 3300 of non-stretchable material is provided, it
should be understood that other materials, e.g., stretchable
materials, may be provided. However, it may be preferable that,
even if stretchable, the material have a predeterminable extension
limit for particular driving momentums and/or applications.
Further, a braided, non-braided, mono-filament, and/or
multi-filament material may be provided.
[0074] Although the fastener 250 includes micro filaments 275 to
anchor into a tissue and resist proximal dislocation after
implantation, it should be understood that any other anchoring
mechanism, e.g., wings as described above, may be provided.
Moreover, any of the features disclosed with regard to the other
example implants disclosed herein may be provided in conjunction
with the fastener 250.
[0075] FIG. 11 shows a needle 5600 that includes many features in
common with needle 3100 described above. However, the needle 5600
is configured to position the fastener 250 to the predetermined
location within the tissue 951, 952.
[0076] Further, it may be desirable to form the needle 5600 to have
a smaller resting or initial diameter than the fastener contained
therein. For example, as illustrated in FIG. 11, the needle 5600,
when the fastener 650, which is identical to fastener 250, is
inserted into the needle 5600, the metal bands 5605 bulge outwardly
to form expanded gaps between the adjacent metal bands 5605. This
may be advantageous to allow the filaments and/or other anchoring
mechanism(s) to engage the adjacent tissue and resist proximal
movement of the fastener as the needle 5600 is retracted. For
example, as illustrated in FIG. 11, the micro anchoring filaments
675 of the fastener 650 are exposed through the longitudinally
extending gap between adjacent bands 5605 of the needle 5600, thus
allowing the filaments 675 to engage surrounding tissue even at the
initial stages of the retraction of the needle 5600. In this
regard, the engagement of the filaments 675 with the tissue may be
sufficient in and of itself to allow proximal retraction of the
needle 5600 while leaving the fastener 650 in its implanted
position. It should be understood, however, that other mechanisms,
e.g, a push rod, may be provided in connection with the needle 5600
to facilitate retraction of the needle 5600 while retaining the
implant 650 in its predetermined location. Since some applications
do not require full penetration of the implant, the needle 5600 may
only need to penetrate to a depth that does not compromise or
pierce the outer surface of the tissue 951, 952.
[0077] The discussion herein, including the discussion below, of
the features of implant 250 also apply to the other implants 350,
550, 650 disclosed herein, except to the extent that any
differences in features are explicitly mentioned.
[0078] The surgical implants 250, which may be absorbable or
non-absorbable, are designed to penetrate a viscera or tissue
planes. The implants 250 are designed to penetrate into the tissue
under controlled rapid deployment to a predetermined depth. The
implant is shaped similarly to a needle with a predetermined
geometry. Each implant 250 has an elongated body 255 that tapers in
a distal region to a needle-like tip 260. Each implant 250 may be
deployed, e.g., by being pushed from a precisely placed hollow
needle or tube containing the implant 250. The implants 250, as
well as any other example implants disclosed herein, may be formed
using e.g., micromachining techniques.
[0079] The micro implants 250 may have a diameter of one
millimeter, or approximately one millimeter, and a length that is
in a range from 5 millimeters to 10 millimeters. According to
example embodiments, the diameter is less than one millimeter.
According to example embodiments, the diameter is in a range from
0.8 millimeters to 1.2 millimeters. It should be understood,
however, that other dimensions may be provided.
[0080] The body 255 of each implant 250 has specifically designed
micro anchoring filaments 275 which arise from the core of the
implant 250 to extend outwardly therefrom. The anchoring filaments
275 are located around the circumference and along at least a
portion of the length of the body 255 of the implant 250. This
allows the implant 250 to resist removal once it has penetrated the
tissue.
[0081] The filaments 275 may have any suitable dimensions. For
example, it may be advantageous to provide a filament tip (i.e.,
free end) diameter of 0.1 millimeters and tapering toward a
diameter of 0.25 millimeters at the body.
[0082] The core, which is, e.g., cylindrical, has a constant
diameter along a substantial length of the body 255 of the implant
250. For example, the core of the implant 250 has a constant
cross-section, and constant diameter, from a proximal end to a
substantially conically shaped tapered portion toward the tip 260.
It should be understood however, that the implants 250 may have a
more continuous taper and/or have a constant or non-constant rate
of taper.
[0083] The anchoring filaments 275 extend outwardly at an angle
with respect to the longitudinal axis of the implant 250. In this
regard, the filaments, in addition to extending outwardly away from
the longitudinal axis, also extend in a proximal direction, away
from the tip 260. This allows for the filaments 275 to slide along
the pierced tissue during distal driving or insertion. However,
proximal movement of the implants 250 from the inserted position is
prevented or resisted by engagement of the outer, free ends of the
filaments 275 with the relatively soft tissue. The filaments 275
may be flexible or substantially rigid. The filaments 275 should,
however, have sufficient stiffness or strength to resist proximal
withdrawal of the implant 250 from the inserted position. Further,
although the filaments 275 are illustrated as being straight, it
should be understood that some or all of the filaments 275 may be
at least partially curved, and/or have one or more bends between
straight portions and/or curved portions. Moreover, the filaments
275 of a given implant 250 may have constant or differing lengths,
radial extensions, and/or angles with respect to the longitudinal
axis of the implant 250.
[0084] The micro filaments 275 may be provided with any appropriate
density and relative spacing, depending on the particular
application. For a given application, a greater density (i.e., a
greater number of filaments per unit of surface area) of smaller
filaments may be provided, or a lesser density of larger filaments
(optionally reinforced with a shape memory alloy, e.g., nitinol
and/or spring-loaded steel), while presenting the same or
comparable suture retention or "pull through strength." The
optional reinforcement could be a "V" shaped portion formed of
shape memory alloy, e.g, nitinol and/or spring-loaded steel. The
filaments 275 may be absorbable or non-absorbable in whole or in
part.
[0085] Although the fastener 250 uses micro filaments 275 to anchor
the fastener 250 into the tissue, it should be appreciated that any
appropriate anchoring mechanism may be provided. for example,
spring loaded tabs may be provided.
[0086] Each implant 250 has a proximal surface 285 via which a
driving force may be applied, e.g., by saline hydraulics, a spring
force or any other appropriate mechanism. The proximal surface 285
of the implant 250 corresponds to the surface from which the suture
3300 proximally extends and is the same or substantially the same
as the diameter of the core 220. However, any appropriate location
or dimensions may be provided for the surface 285.
[0087] Although the implants 250 have cores with circular cross
sections, it should be understood that other cross-sections may be
provided, e.g., rectangular, triangular, oval, polygonal, and/or
any other regular or irregular shape. Further, it should be
understood that the anchoring micro filaments 275 may be evenly
spaced apart or may have non-uniform spacing. Moreover, the
filament density, i.e., the number of the filaments 275, 575, 675
per unit of surface area of the core may be constant, or may
vary.
[0088] FIG. 12 shows a distal end portion of an implant 550, which
is identical to the implant 250 except for the distal end portion
illustrated in FIG. 12. The distal arrangement includes three
concave surfaces 580 that distally converge to form the sharp point
560. Separating the three concave surfaces 580 are three tapered
cutting edges 585. These tapered cutting edges 585 may facilitate
penetration of tissue, e.g., soft tissue. Although the end portion
illustrated in FIG. 12 includes three concave surfaces 580
separated by three corresponding tapered cutting edges 585, it
should be understood that any appropriated number of concave
surfaces 580 and corresponding cutting edges 585 may be
provided.
[0089] Moreover, FIG. 13 illustrates a surgical micro implant or
fastener 350 that has features in common with the fastener 250 and
may be used in conjunction with any of the fastening applications
described herein. However, the fastener 350 includes a corrugated
body 351. The body 351 includes grooves 353 that extend axially
along the length of the body 351. Thus, extending circumferentially
around the body 351, a plurality of grooves 353 alternate with a
plurality of ridges 355. Further, the fastener body 351 includes a
pair of split portions or wings 357 and 358. The split portions are
formed by respective splits or cuts 359 into the body 351. In this
regard, the splits 359 may be formed by making a cut radially into
the body 351 and extending in an axial direction. Thus, the two
split portions 357 and 358 are attached to the remainder of the
body 351 at a distal position and extend proximally to free ends.
The free ends include a plurality of sharp protrusions along a
curved surface. These points are formed due to the corrugations. In
particular, the ridges 355 form the sharp protrusions. In
particular, the ridges 355 form the sharp protrusions, as
illustrated in the inset partial side view in FIG. 13, which are
advantageous for gripping tissue and preventing distal sliding of
the fastener 250. Although each split portion 357 and 358 includes
three such protrusions as illustrated, it should be understood,
that the fastener 350 may be designed such that one or more of the
split portions has any other number of protrusions, including a
single sharp protrusion. For example, if a larger number of sharp
protrusions are desired, the body 351 could be more densely
corrugated (i.e., a greater number of alternating grooves 353 and
ridges 355 could be provided) and/or the angle of the cut or slice
could be adjusted. Further, the length of proximal extension of the
projections may be adjusted by varying the depth of the grooves 353
with respect to the ridges 355.
[0090] The split portions 357 and 358 do not substantially impede
distal insertion into tissue but resist proximal movement from an
insertion location by engaging the tissue. It has been discovered
that the combination of the pointed and/or sharp-edged proximal
ends of the split portions 357 and 358 with the alternating ridges
on the proximal end of the split portions creates improved
performance.
[0091] Further, the split portions or wings 357 and 358 are axially
offset from each other. For example, split 357 is axially located
at position a along axis x and split 358 is axially located at
position b along axis x. This allows for greater structural
strength of the other portions of the body 351 as compared to a
non-offset configuration. In particular, since the cuts progress
continually radially inward as they progress distally, a non-offset
portion would have a substantially smaller amount of material in
cross-section in the distal end of the cut. This would lead to a
mechanically weak point or region along the axis of the body and
could lead to mechanical failure, especially in fasteners of small
dimensions.
[0092] The distal tip of the fastener 350 is pyramidal, with a
sharp point, and a plurality of surfaces separated by edges that
converge at the sharp point. Although four planar surfaces are
provided, it should be appreciated that any appropriate suitable
number of surfaces may be provided and that one or more or all of
the surfaces may be non-planar.
[0093] The fastener 350 also includes a hooked end portion 360. The
hooked portion may be suitable for coupling any other temporary
and/or permanent implant. For example, the hook may be used to
secure the suture 3300. However, the fastener 350 may
advantageously be formed with the suture 3300 extending therewith,
e.g., by being molded or co-extruded with the suture 3300, as
described with regard to fastener 250. Moreover, the hooked end
portion may be dispensed with.
[0094] The fastener 350 may be produced by first forming the body
351 with the corrugations, e.g., by injection molding or extrusion,
and subsequently forming wings 357 and 358, e.g., by cutting
radially into the side of the body 351. As illustrated, the cut is
curved, with an angle (at the proximal entry point), relative to
the longitudinal axis of the body 351, that gradually decreases
from the proximal initial cutting location toward the distal end of
the fastener 350 and eventually becoming linear. Although the spit
or cut of the illustrated example is made with a curved or varying
angle with respect to the longitudinal axis of the body 351, it
should be understood that any appropriate cut, including a linear
cut, may be made.
[0095] Although the fastener 350 includes two wings spaced equally
around the radial periphery of the body 351, it should be
appreciated that any number of wings, including a single wing may
be provided and at any appropriate spacing around the radial
periphery.
[0096] Furthermore, it should be understood that the corrugated
split-bodied configuration may be employed in combination with any
of the other fastener features disclosed herein. For example, the
fastener 350 may include filaments in addition to the split
portions.
[0097] Referring to FIG. 14, a surgical system 5000 includes a
handpiece 5100 configured to drive the fastener 250, for example,
to a predetermined depth. The depth is limited, e.g., by a
predetermined amount of slack in the suture 3300. The proximal end
of the suture 3300 is attached to a capstan 5105 configured to
adjust the length of the suture 3300 extending from capstan 5105.
In this regard, the capstan 5105, which may be actuated by a motor
system or any other appropriate mechanism, may set the slack by
reeling off a predetermined length of suture 3300 prior to driving
the fastener 250 and/or the capstan 5105 may have a predetermined
amount of allowed rotation such that driving of the fastener 250
causes the capstan to rotate only the predetermined amount, thereby
setting the driving depth of the fastener 250. The determination of
the depth and/or the driving velocity of the fastener 250 may be
determined in a processor 5110 of the handpiece 5100. The device
3000 described above may include an analogous handpiece. Although
the processing takes place in a processor 5110 located in the
handpiece 5100, it should be understood that the processor may be
disposed in other parts of the device, e.g., in the shaft 5115
and/or the processing may take place location separate from the
handpiece 5100 and shaft 5115, e.g., at a remote computing unit
that communications, e.g., wirelessly, with the surgical device.
Further, it should be understood that the capstan 5110 may be
disposed in the shaft 5115.
[0098] The shaft 5115 includes many features, e.g., the
maneuverability, the winding mechanism and the clipping mechanism,
of the catheter 3000 described above.
[0099] During a procedure, the system 5000 operates in a manner
analogous to the device 3000 described above. However, one or more
of the implants 3200 are replaced by the implants 250. The implants
250 may be hydraulically delivered, or delivered by a piercing
needle, or any other appropriate driving mechanism. Regarding
hydraulic delivery, it is noted that a very precise force may be
delivered at the distal end portion of the shaft 5115 to drive the
fastener 250. This force may be controlled by the processor 5110 in
connection with hydraulics, e.g., in the handpiece. For example,
the hydraulic fluid, e.g., saline, may be disposed in a tube
extending along the shaft 5115. Hydraulics and controls in the
handpiece 5100 may then transmit a very precise force, via the
hydraulic fluid extending along the shaft 5115, to the distal end
portion of the shaft 5115 to precisely drive the fastener 250.
[0100] As illustrated in FIG. 14, the fastener 250 has been driven
into the tissue 951, 952. As the shaft is retracted from the
implantation location, e.g., to be repositioned at the opposed
layer of tissue, the capstan 5105 reels off a corresponding length
of suture 3300. Further after driving a second implant, e.g.,
another fastener 250, the two sutures 3300 are wound in the manner
described above with respect to device 3000. During the winding the
capstan may be actuated, e.g., according to control signals from
the processor 5110 to progressively retract the suture 3300.
However, the capstan may be controlled to resist any rotation,
e.g., where the capstan is mounted to move in connection with a
retracting winding tube such as the tube 5400 described below. Each
suture 3300 may have its own respective capstan 5105 or the sutures
3300 may share a capstan mechanism. If the sutures 3300 share a
capstan mechanism, it may be advantageously be configured with a
mechanism to retract/extend each suture 3300 independently, e.g.,
during the fastener driving procedures. Moreover, the capstan(s)
5105 may be coupled to the suture twisting mechanism to avoid any
undesired twisting proximal to the twisting interface, e.g,
hooks.
[0101] FIG. 15A illustrates the driving of an anchoring fastener
250 through a first tissue 1951 and into a second tissue 1952 using
the device of FIG. 14.
[0102] FIG. 15B illustrates the first and second tissues 1951, 1952
of FIG. 15A with the anchoring fastener 250 implanted in the first
tissue and the suture 3300 attached to the anchoring fastener 250
extending through the first tissue 1951.
[0103] FIG. 15C illustrates the first and second tissues 1951, 1952
of FIG. 15B with a second anchoring fastener 250 driven through the
second tissue 1952 and into the first tissue 1951 and with the
device of FIG. 14A twisting the sutures 3300 attached to the
anchoring fasteners 250.
[0104] FIGS. 15D to 15F sequentially illustrate the retraction,
twisting, and clamping of sutures attached to the anchoring
fasteners of FIG. 15C to join the two tissues.
[0105] FIG. 15G shows fasteners driven into the tissues at angles
and locations that differ from the procedure of FIGS. 15A to
15F.
[0106] FIGS. 15D to 15F sequentially illustrate an approximation
procedure employing the fasteners 250. As illustrated in FIG. 15C,
the fasteners 250 have been driven into the opposed tissues 1951
and 1952 and the sutures 3300 are in the process of being refracted
and twisted in manner analogous to that described above with
respect to device 3000. Within the tube portion 5115 is a winding
tube 5400 that rotates and retracts, along with its winding hooks
5405 to wind and retract the sutures 3300. A pair of actuatable
clip elements 5500 are disposed at the distal end portion of the
tube 5115. These elements 5400, 5405, and 5500 have features
analogous to elements 3400, 3405, and 3500 described above with
regard to device 3000.
[0107] As illustrated in FIG. 15D, the sutures 3300 are in a taut
state as the tissues 1951, 1952 are moving toward each other due to
the twisting and retraction of the proximal portions of the
sutures.
[0108] As illustrated in FIG. 15E, the tissues 1951, 1952 have been
brought into contact with each other and are being held securely by
the sutures 3300.
[0109] As illustrated in FIG. 15F, the clip elements 5500 have been
actuated to clip and join the sutures 3300 in the same manner
described above with regard to clip members 3500.
[0110] It is noted that this arrangement does not require
penetration of full thickness of the respective tissues 1951 and
1902 into which the implants 250 are implanted. That is, the sharp
tips of the anchoring fasteners are not exposed beyond the outer
walls of the tissue need not be pierced. This may be advantageous
to reduce trauma to the tissue and limit the possibility of
damaging any adjacent tissues. It should be understood, however,
that the fasteners 250 may be driven to a depth such that the tip
extends beyond the outer wall of the respective tissue 1951, 1952
into which the respective fastener is implanted.
[0111] The arrangement of FIG. 15F maintains a closure that secures
the illustrated end portions of the two tissues 1951, 1952
together.
[0112] FIG. 15G shows an arrangement that is analogous to the
arrangement of FIGS. 15A to 15F, but differs in that the angle
between the axes along which the fasteners 250 are driven is less.
Further, the fasteners 250 are driven through end faces of the
tissues 1951, 1951. In this regard, it should be understood that
the fasteners 250 may be driven at any appropriate angle
(including, e.g., substantially 180 degrees) to each other and at
any appropriate angle or location with respect to the respective
tissues 1951, 1952.
[0113] The driver of any example implants disclosed herein may be
configured to drive any of the example fasteners described herein
to a predetermined depth. The precision of the depth may be
accomplished by any appropriate mechanism, e.g., a precise
hydraulic driving force, e.g., with saline fluid, engagement with
flanges or other similar stops, or a suture that tautens to limit
the depth. Further the depth may be monitored using fluoroscopy or
any other appropriate imaging mechanism. The driving mechanism may
include pressurized saline or other hydraulic fluid that is
pressurized through the endoscopic catheter shaft. Thus, very
precise control may be accomplished.
[0114] According to example embodiments, a computer system, e.g.
including processor 5110, may determine the location of two points,
e.g., and determine a distance therebetween. The distance may be
used as a desired distance to which the fastener is fired. The
implanting distance may be set by any appropriate adjustment
mechanism, e.g., an adjustable stop or flange, a cord or suture
attached to the fastener, and/or precisely controlling the speed
and momentum of the fastener during the implantation (e.g., by
finely controlling a hydraulic propulsion system). Such
measurements, determinations, and/or control of depth may be
employed in conjunction with any implantation of fasteners
disclosed herein.
[0115] The fasteners are preferably driven at a speed greater than
50 meters per second, more preferably in a range of 50 to 350
meters per second, and most preferably at 350 meters per second.
However, it should be understood that the fasteners may be driven
at any suitable speed sufficient for the fasteners to puncture
tissue.
[0116] Modern manufacturing processes allow for near nano
technology applications. This allows the implant 250 and any other
implants disclosed herein to be manufactured in a size and
complexity that may not have been possible in years past. The
implant 250 may be injection molded of either absorbable or non
absorbable polymers and then processed to add the features of the
protruding filaments 275.
[0117] Although the implants 250 are formed of polymer, it should
be appreciated that any appropriate material may used, e.g., metal
or a composite material.
[0118] In order to accurately penetrate adjacent tissues that are
not held or secured on a distal side, a rapid penetration of the
layer(s) of tissue may be required in order to effect a desired
penetration. If an implant 250 is applied slowly, the tissue may be
pushed distally away by the implant and/or needle without adequate
penetration. Thus, some example delivery mechanisms eject the
implant a relatively high velocity. In some preferred examples,
saline is used to pressurize the channel within the catheter or
needle at such a rate that the plunger will eject the implant 250
at the precise velocity. Other example embodiments utilize a
spring-loaded mechanical mechanism to eject the implant. Further
example embodiments push the implant using long push rods which run
the length of the catheter. The ejection modality is
computer-controlled. However, it should be understood that the
ejection may be, e.g., operator-controlled. For example, the
ejection force may be predetermined and repeatable by a mechanical
system, e.g., a spring-loaded system, which is triggered by an
operator, e.g., a surgeon.
[0119] Any of the mechanisms and devices described above may be
utilized with pressure sensing, e.g., sensing of the pressure
required to progress a needle or fastener using any appropriate
pressure sensing mechanism. The pressure may be relayed to, e.g., a
computer control system, including, e.g, processor 5110, in a hand
piece, e.g., handpiece 5100, to which the implanting device of any
of the embodiments described herein is coupled. Further, imaging
data may be obtained, including, e.g., ultrasound or other digital
imaging, and relayed to, e.g., the computer control system in a
hand piece. This information, including pressure and/or imaging
information and/or any other sensed information may be used by the
control system to appropriately control the insertion of the
various needles and/or implants into the tissue. For example, the
control system may control the rate, location, angle, and/or depth
of insertion. Such precise control may be particularly advantageous
when repairing defects in the heart, which requires very precise
placement of implants.
[0120] The various mechanisms described herein provide for a tissue
repair system that allows great flexibility. For example, smaller
defects may be repairable with a single fastener (e.g., fastener
100 or any other fastener described herein), and larger defects may
be repairable with a plurality of fasteners, with or without a
washer or plate 2200, as described above. Larger defects, e.g.,
hernias or large holes, may be more suited for a mesh 1300
application, as described above.
[0121] The various implants described herein, e.g., fasteners 250,
350, 550, 650 plates 3200, and clip elements 3500, 4500, may be
formed by molding, e.g., injection molding.
[0122] Moreover, the fasteners 250, 350, 550, 650 may be provided
with a head element that restrains proximal movement of the tissue
with respect to the fastener. Further, the head elements may be
fixed or movable, e.g., where the fasteners have ratcheted or
threaded proximal end portions configured to receive corresponding
ratcheting or threaded head elements.
[0123] Further, any of the implantable elements described herein,
e.g., fasteners 250, 350, 550, 650, plates 3200 4200, and clip
elements 3500, 5500, and/or sutures 3300, may be formed wholly or
partly of a material absorbable into the patient's body, or of a
non-absorbable material, depending on, e.g., the specific
application. For example, these elements may be formed of
polyglycolic acid (PGA), or a PGA copolymer. These elements may
also, or alternatively, be formed of copolymers of polyester and/or
nylon and/or other polymer(s). Moreover, these elements may contain
one or more shape-memory alloys, e.g., nitinol and/or spring-loaded
steel.
[0124] Absorbable materials may be advantageous where there is a
potential for misfiring or improper locating of the various
implants. For example, in a situation where a fastener or other
implant is driven at an unintended location, or where the tissue
does not properly receive the implant, the implant even where not
needed, would relatively harmless, as it would eventually absorb
into the patient's body.
[0125] Although the present invention has been described with
reference to particular examples and exemplary embodiments, it
should be understood that the foregoing description is in no manner
limiting. Moreover, the features described herein may be used in
any combination.
* * * * *