U.S. patent application number 11/313193 was filed with the patent office on 2006-05-11 for surgical fastening system.
Invention is credited to Sanjay S. Bagade, Michael D. Laufer.
Application Number | 20060100643 11/313193 |
Document ID | / |
Family ID | 34976213 |
Filed Date | 2006-05-11 |
United States Patent
Application |
20060100643 |
Kind Code |
A1 |
Laufer; Michael D. ; et
al. |
May 11, 2006 |
Surgical fastening system
Abstract
Devices and systems related to surgical fasteners and more
specifically to surgical fasteners suitable for use in both open
procedures, and minimally or less invasive procedures where the
operative site is remote from the surgeon.
Inventors: |
Laufer; Michael D.; (Menlo
Park, CA) ; Bagade; Sanjay S.; (San Jose,
CA) |
Correspondence
Address: |
LEVINE BAGADE LLP
2483 EAST BAYSHORE ROAD, SUITE 100
PALO ALTO
CA
94303
US
|
Family ID: |
34976213 |
Appl. No.: |
11/313193 |
Filed: |
December 19, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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10798018 |
Mar 11, 2004 |
|
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11313193 |
Dec 19, 2005 |
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Current U.S.
Class: |
606/139 |
Current CPC
Class: |
A61B 2017/0417 20130101;
A61B 2017/00858 20130101; A61B 2017/0443 20130101; A61B 17/10
20130101; A61B 2017/00535 20130101; A61B 2017/003 20130101; A61B
2017/0409 20130101; A61B 2017/0419 20130101; A61B 2017/00004
20130101; A61B 2017/00898 20130101; A61B 2090/037 20160201 |
Class at
Publication: |
606/139 |
International
Class: |
A61B 17/10 20060101
A61B017/10 |
Claims
1. A surgical fastening system comprising: a tubular member having
a proximal and distal ends and a lumen extending therebetween, a
distal portion located at the distal end of the tubular member, the
distal portion having a distal tip being configured to pierce
tissue, the distal portion having a lumen extending between the
tubular member lumen and an opening in a wall of the distal
portion; at least one surgical fastener slidably located entirely
inside the tubular member lumen, where the surgical fastener
comprises a first anchor member, a second anchor member, and a
connecting portion separating the first and second anchor members;
an advancing member slidably located within the tubular member
lumen such that advancement causes a distal portion of the
advancing member to advance the surgical fastener through the
tubular member.
2. The surgical fastening system of claim 1, where the tubular
member is sufficiently flexible to navigate tortuous anatomical
passages within a human body.
3. The surgical fastening system of claim 1, where the surgical
fastener is located entirely within the tubular member lumen.
4. The surgical fastening system of claim 1, further comprising a
gate member in fluid communication with the tubular member lumen or
distal portion lumen, the gate member having a portion that impedes
movement of at least one surgical fastener.
5. The surgical fastening system of claim 4, where the gate member
comprises a flexible valve, where the valve increases resistance to
the fastener during advancement of the fastener.
6. The surgical fastening system of claim 4, where the gate member
is moveably located in the distal portion lumen such that it may at
least partially occlude the opening.
7. The surgical fastening system of claim 1, where the connecting
portion of the surgical fastener has a greater elasticity than
either the first or second anchor member such that when tissue is
placed between the anchor members, the connecting member is placed
in a tensile state providing a compressive force against the tissue
by the anchor members.
8. The surgical fastening system of claim 1, where the advancing
member is releasably coupled to at least one surgical
fasteners.
9. The surgical fastening system of claim 1, where the opening is
at the distal tip.
10. The surgical fastening system of claim 1, where the distal tip
is inserted into the distal portion.
11. The surgical fastening system of claim 1, where the surgical
fastener is an I shaped, H shaped, helical shaped and pig-tail
shaped fastener.
12. The surgical fastening system of claim 11, where the fastener
is resilient and assumes the I shape, H shape, helical, or pig-tail
shape upon deployment from the tubular member.
13. The surgical fastening system of claim 1, where the at least
one surgical fastener comprises a plurality of surgical
fasteners.
14. The surgical fastening system of claim 13, where the plurality
of surgical fasteners are each connected.
15. The surgical fastening system of claim 1, where the tubular
member comprises a reinforcing member to increase an axial strength
of the tubular member.
16. The surgical fastening system of claim 1, where at least the
first anchor member and the second anchor member each are
expandable from a first state to a second state where the second
state is of a larger displacement than the first state.
17. The surgical fastening system of claim 16, where the second
state is of a larger volume than the first state.
18. The surgical fastening system of claim 16, where the first
anchor member and second anchor member are compressible upon
application of a compressive force and assume the second state upon
removal of the compressive force.
19. The surgical fastening system of claim 18, where the first
anchor member and second anchor members are sized relative to the
tubular member lumen so that the tubular member provides the
compressive force upon insertion of the anchor members into the
tubular member.
20. The surgical fastening system of claim 18, where connecting
portion is also expandable from the first state to the second state
where the second state is of a larger volume than the first
state.
21. The surgical fastening system of claim 16, where at least the
first and second anchor members comprise a material that expands
upon contact with a fluid.
22. The surgical fastening system of claim 1, where the tubular
member further comprises a further comprising a fluid delivery, and
where the distal tip further comprises a port in fluid
communication with the fluid delivery lumen.
23. The surgical fastening system of claim 1, where the connecting
portion has a greater elasticity than either the first or second
anchor member such that when tissue is placed between the anchor
members, the connecting member is placed in a tensile state
providing a compressive force against the tissue by the anchor
members.
24. The surgical fastening system of claim 1, where the connecting
portion has a cross sectional area less than a cross sectional area
of either the first or second anchor member.
25. The surgical fastening system of claim 1, where the advancing
member is detachably coupled to the fastener.
26. The surgical fastening system of claim 25, where the advancing
member is detachably coupled to the fastener via a detachable
joint.
27. The surgical fastening system of claim 26, where the detachable
joint comprises an electrolytic joint.
28. The surgical fastening system of claim 26, where the detachable
joint comprises a polymer.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present invention is a continuation of U.S. patent
application Ser. No. 10/798,018 filed on Mar. 11, 2004, the
entirety of which is incorporated by reference.
FIELD OF THE INVENTION
[0002] The present invention relates to surgical fasteners and more
specifically to surgical fasteners suitable for use in both open
procedures, and minimally or less invasive procedures where the
operative or surgical site is not directly accessible by the
surgeon.
BACKGROUND OF THE INVENTION
[0003] Surgical fasteners are known to be an alternative to
traditional suturing techniques for procedures involving tissue
closure, connection, or repair. One undesirable aspect of manual
suturing is that the suturing process adds time to the overall
surgical process. Moreover, manual suturing often requires that the
operative area is readily accessible so that the medical
practitioner can manipulate the suture and associated needle
through both sides of the tissue, connection or repair site.
Presently, surgical fasteners are known to provide a means to close
an open surgical incision or wound, hold together pieces of soft
tissue, attach devices to tissue, or repair tom tissue in
orthopedic/musculoskeletal applications. Such surgical fasteners
are often used where there is adequate access to the operative
area, or for invasive, open procedures.
[0004] Due to the inherent risks and complexities of invasive
surgical procedures, there is an increasing need for the ability to
perform surgical procedures in a minimally invasive manner. In most
cases, the recuperative time and lowered expense of a minimally
invasive procedure makes it a far more desirable option to an
alternative comparable invasive/open surgical procedure. The use of
surgical fasteners in minimally invasive procedures may be
desirable to increase the speed and efficiency of the procedure.
Such fasteners may also open the possibility of performing a
minimally invasive procedure for what was previously limited to an
open surgical procedure.
[0005] In addition, suturing techniques requires considerable skill
and dexterity especially when tying knots in the suture or
otherwise manipulating the suture. The ability of a medical
practitioner to manipulate a suture as well as knot the ends of the
suture are further complicated when the site is not directly
accessible to the practitioner. In such cases, even if the
complexity of suturing does not prevent the procedure from being
completed in a minimally invasive manner, the length of the
procedure is likely to increase.
[0006] Conventional fasteners do not easily lend themselves for use
in minimally invasive surgical procedure. As one example, the
complexity of the known fastener-delivery devices requires devices
with large profiles and limited flexibility further thereby
limiting the potential for such devices to access remote locations.
Conventional surgical fasteners, especially, "I-shaped" or
"H-shaped" fasteners are unsuitable for remote procedures due to
their complex deployment mechanisms and inability to navigate
tortuous pathways using access devices commonly used for minimally
invasive procedures (e.g., catheters, introducer devices,
scope-type devices such as endoscopes, bronchoscopes,
colonoscopies, etc.). Examples of such fasteners and devices are
discussed in U.S. Pat. No. 4,006,747 to Kronenthal et al, U.S. Pat.
No. 4,235,238 to Ogiu et al., U.S. Pat. No. 4,669,473 to Richards
et al., U.S. Pat. No. 5,941,439 to Kammerer et al, U.S. Pat. No.
6,039,753 to Meislin, and U.S. Patent Publications U.S.
2003/0097148 to Valimaa et al, U.S. 2003/0187465 to Bailly et al.
Each of the foregoing patents and/or patent applications is hereby
incorporated in their entirety by reference.
SUMMARY OF THE INVENTION
[0007] The present invention includes a surgical fastener for
deployment through a device (such as a needle, cannula, catheter,
etc.), where the fastener comprises a first anchor member, a second
anchor member, and a connecting portion separating the first and
second anchor members, where at least the first anchor member and
the second anchor member each are expandable from a first state to
a second state where the second state is of a larger size than the
first state, where the larger size may be achieved by an increase
in displacement (e.g., volume, profile, configuration, etc.) of a
portion of the fastener or the entire fastener. For example, as it
assumes the second state, the anchor may change in shape or conform
to a profile that is of a larger size than the profile of the first
state. Alternatively, or in combination, the increase in volume may
be achieved by relaxing a previous state of compression of the
fastener portion. In the latter case, the fastener portion may
comprise a resilient material that is compressible, and/or the
fastener portion may be hollow, or have a cavity, such that the
outer perimeter of the anchor portion may be folded into the cavity
to assume the first state, or compress the cavity to conform to a
smaller state.
[0008] The surgical fastener may also comprise a first means for
anchoring the fastener, a second means for anchoring the fastener
and a connecting portion separating the first and second means for
anchoring. Where the means for anchoring may be any of the anchor
portions described herein.
[0009] The invention also includes a surgical fastening system
comprising, a tubular member having a proximal and distal end and a
lumen extending therebetween, the tubular member being sufficiently
flexible to navigate tortuous anatomical passages within a human
body, a distal portion located at the distal end of the tubular
member, the distal portion having a distal tip being configured to
pierce tissue, the distal portion having a lumen extending between
the tubular member lumen and an opening in the distal portion, at
least one surgical fastener slidably located entirely inside the
tubular member lumen, where the surgical fastener comprises a first
anchor member, a second anchor member, and a connecting portion
separating the first and second anchor members, and an advancing
member slidably located within the tubular member lumen such that
advancement causes a distal portion of the advancing member to
advance the surgical fastener through the tubular member. The
system of the present invention may be directed to the desired site
using a catheter-guidewire configuration, shaped catheter, a
steerable catheter, a scope-type of device (e.g., such as
endoscopes, gastroscope, colonoscope, bronchoscope, or any type of
scope used to access sites within the body.)
[0010] It should be noted that alternate variations of the present
invention include fastening system of the present invention used
with conventional fasteners and/or fasteners of as described
herein.
[0011] The present invention is useful in many surgical procedures
requiring fastening systems, including but not limited to,
procedures for fastening or repairing tissue or attachment of
implant materials to tissue. The present invention is suitable for,
but not limited to, use in the heart, stomach, gastro-intestinal
tract, etc. While the faster and fastening system may be used in
open procedures, the devices and systems may also be used in
minimally invasive procedures where the operative site is remotely
accessed using minimally invasive techniques including
catheterization and/or endoscopic or similar means.
[0012] The inventive devices are especially suited for advancement
via a minimally invasive technique by providing features which
improve the ability of the surgeon to deploy the fastener with
accuracy and effectuate a proper seal with the fastener. The
minimally invasive technique also may allow for visual inspection
of the placement of the anchor.
[0013] This application incorporates by reference an application
filed Mar. 11, 2004 entitled "SURGICAL FASTENER" having application
Ser. No. 10/798,465.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] FIGS. 1A-1B, illustrate a side view of a basic variation of
a fastener of the present invention.
[0015] FIGS. 2A-2H illustrate additional examples of various
fasteners.
[0016] FIGS. 3A-3B illustrate a variation of a fastener having a
single diameter (or similar cross-sectional measurement) prior to
deployment.
[0017] FIG. 3C illustrates a variation of a fastener having an
insert.
[0018] FIG. 4A-4C illustrate an example of a fastener system
deploying a fastener.
[0019] FIG. 4D illustrates another variation of a fastener system
deploying a fastener.
[0020] FIGS. 5A-5B illustrate another variation of a fastener
system.
[0021] FIG. 6A illustrates a deployed fastener having elastic
properties.
[0022] FIG. 7A-7C illustrate variations of fastening systems of the
present invention.
[0023] FIG. 7D illustrates a variation of a fastening system of the
present invention having a plurality of connected fasteners.
[0024] FIGS. 8A-8F illustrate additional features of fastening
systems of the present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0025] The following illustrations are provided as variations of
the present invention. It should be understood that there are many
combinations of the present invention and that figures illustrating
all variations of the invention would be numerous. Therefore, the
invention is intended to include combinations of aspects and
features of the illustrated embodiments, or combinations of the
specific embodiments themselves.
[0026] FIGS. 1A-1B, illustrate a side view of a basic variation of
the inventive fastener 100. As seen in FIG. 1A, the fastener 100
includes a first anchor member 102 and a second anchor member 104
and a connecting portion 106 separating the two anchor members 102
104. The "I-type" fastener shape illustrated in FIGS. 1A-1B is
merely for illustrative purposes. Naturally, the anchor portions
102 104 may have a variety of shapes, cross-sections, and
configuration as discussed herein. However, the anchor portions 102
104 will generally have a shape that allows for retention of a
medium (for example, torn/damaged tissue, two or more discrete
pieces of tissues, one or more implants to tissue, a combination
thereof, etc.) between the anchor portions 102 104 upon deployment
of the anchor 100. Portion(s) of the fastener 100 will be operable
between a first and second state where in the second state, a
portion or portions of the fastener 100 will be of a larger size
and/or profile than the first state. In the variation shown in FIG.
1B, the fastener 100 anchors 102 104 are configured so that they
expand from the first state, shown in FIG. 1A, to a larger second
state.
[0027] In use, the fastener 100 may be delivered to the operative
site when the portions of the fastener 100 are in the first state.
Upon deployment, selected portions of the fastener 100 assume the
larger second state. This configuration allows for delivery of the
fastener 100 through an opening in the medium where the opening is
smaller than a diameter (or other similar dimension) of the
fastener 100 portions after deployment. In some variations of the
invention, construction of the fastener 100 allows only a portion
(e.g., a single anchor, both anchors, the connecting portion, or a
combination thereof) to expand into the second state. In other
variations, the entire fastener 100 may be constructed to assume
the second state upon deployment. It is contemplated, that the
various portions of the fastener 100 may expand differently as
required for the particular application (e.g., one or more portions
expand at a different rate, a different size, etc.)
[0028] Expansion of the fastener 100 from the first to the second
state may be accomplished a variety of ways. For example, the
fastener 100 may be constructed of a shape or material that allows
compression of the fastener portion, either by application of a
compressive force or application of a vacuum, etc. Alternatively,
or in combination, the fastener 100 may include a material that
swells or expands given the addition of a fluid (e.g., natural body
fluids or fluids introduced during the surgical procedure.)
[0029] Examples of these materials include biodegradeable and
non-biodegradeable polymers, elastomers, shape-memory alloys, other
alloys, etc.) For example, carbonate copolymer, polyether ester
copolymer, albumin, gelatin, starch, cellulose, dextrans,
polysaccharides, fibrinogen, poly (D,L lactide), poly
(D,L-lactide-co-glycolide), poly (glycolide), poly
(hydroxybutyrate), poly (alkylcarbonate) and poly (orthoesters),
EVA copolymers, silicone rubber and poly (methylmethacrylate).
Particularly preferred polymeric carriers include poly
(ethylene-vinyl acetate), poly (D,L-lactic acid) oligomers and
polymers, poly (L-lactic acid) oligomers and polymers, poly
(glycolic acid), copolymers of lactic acid and glycolic acid, poly
(caprolactone), poly (valerolactone), polyanhydrides, copolymers of
poly (caprolactone) or poly (lactic acid) with polyethylene glycol,
PET, PETE, and blends thereof.
[0030] In any case, the second state of the fastener comprises a
larger profile or configuration as compared to the first state. As
stated above, this permits securing of the anchoring portions 102
104 about the medium and/or securing of the connecting portion 106
within the medium. Another advantage of the invention is that the
opening in the medium created during deployment of the fastener 100
may be smaller than would otherwise be possible if the fastener did
not expand into the second state upon or after deployment.
[0031] It is also contemplated that the fastener may incorporate a
variety of additives, coatings, adjuncts, etc. For example, the
fastener (or only portions of the fastener) may include a
lubricious coating to improve advancement of the fastener in the
delivery system. The fastener may include non-proliferative drugs,
thrombogenic additives, non-thrombogenic additives,
non-inflammatory medicines, additives to induce fibrosis for wound
closure, anti-platelet, anti-coagulent, growth factors,
gene-transductors, cell matrix, glue, cement, protein, hydrophilic,
hydrophobic, lipidphillic, lipidphobic, or combinations where
appropriate.
[0032] FIGS. 2A-2H illustrate examples of various fasteners 100 of
the present invention. It should be understood that the fasteners
100 of the present invention may have a number of configurations as
required for the specific application. These figures are intended
to illustrate some possible variations of the invention. As noted
herein, where possible, combinations of features of various
embodiments and the embodiments themselves are within the scope of
the invention. FIG. 2A illustrates a fastener 100 similar to that
shown in FIGS. 1A-1B. FIG. It is contemplated that for the basic
configuration of the fastener 100 illustrated in FIG. 2A (and where
appropriate for other variations) the anchor portion 102 104 or the
connecting portion 106, individually or collectively, may have
cross sections of a variety of shapes, including but not limited to
circular, rectangular, square, star-shaped, etc.
[0033] FIG. 2B illustrates a variation of the fastener 100 where
the anchor portions 102 104 have a spherical shape. In this
variation, the anchor portions 102 104 are illustrated as having a
cavity 108. The cavity 108 may assist in reducing the size of the
anchor portions 102 104 into the first state. Moreover, as
described herein, the cavity 108 (as well as other portions of the
fastener 100) may serve as a reservoir for various medications,
drugs, etc. Furthermore, variations of fasteners of the present
invention may be non-porous if the particular application requires
(e.g., where prevention of tissue in-growth is required.
Alternatively, variations of the fastener may be porous.
Furthermore, the fastener may be selected such that certain
portions of the fastener are porous while others are non-porous
(e.g., porous anchor members combined with a non-porous connecting
member, non-porous anchors with a porous connecting member, etc.)
In such variations, porous materials may be selected for
construction of the anchor or non-porous materials may be altered
to contain pores.
[0034] FIG. 2C illustrates another variation of the fastener 100 in
which the anchor portions 102 104 comprise cross-shaped members.
FIG. 2D illustrates a fastener 100 having anchor portions 102 104
that are planar-disc-shaped. In such a configuration, the increased
surface area of the anchor portions 102 104 may provide better
contact between the fastener 100 and the medium to allow for tissue
in-growth or for delivery of a therapeutic substance carried by the
fastener 100. FIG. 2E illustrates a variation of a fastener 100 of
the present invention where the first anchor portion 102 and the
second anchor portion 104 comprise different shapes. It should be
noted that variations of the invention include fasteners 100 having
combinations of anchor portions as illustrated herein or variations
thereof.
[0035] FIG. 2F illustrates a variation of a fastener 100 of the
present invention where the first anchor portion 102 and the second
anchor portion 104 extend in different directions.
[0036] FIG. 2G illustrates a variation of the fastener 100 of the
present invention where the anchor portions 102 and 104 comprise
"pig-tail" type fasteners. In this variation, the anchor portions
102 and 104 the coils of the pig-tail may separate to capture
tissue therebetween. Alternatively, the opposing anchor portions
102 and 104 may be used to capture the tissue. During placement of
the fastener 100 the pig-tail anchors may be straightened in the
device for delivery. Alternatively, the coils may be compressed in
a radial dimension to expand upon deployment from the delivery
system. A variation of a pig-tail fastener may include a helical
shaped fastener or fastener with helical anchor portions.
[0037] FIG. 2H illustrates another variation of the invention where
a fastener 100 includes protrusions 112. The protrusions 112 may
assist in retaining the anchors and or fastener in the deployment
site. Alternatively, or in combination, the protrusions 112 may
comprise bio-active substances as described herein. Although the
figure illustrates the protrusions as on the anchor portions only,
the invention includes fasteners 100 having protrusions 112 on the
connecting portion 106 as well. Alternatively, the protrusions 112
may be located only on the connecting portion 106.
[0038] The invention also contemplates that the anchor portions
described herein may be configured/suited for attachment of
external devices/implants/objects/etc. For example, one possible
use of the inventive fastener is placing the fastener in the wall
of an organ, then attaching an implant to the organ's wall by
attaching the implant to the anchor portions of the fastener.
[0039] FIGS. 3A-3B illustrate another variation of a fastener 100
of the present invention. In this variation, as shown in FIG. 3A,
in the pre-deployment or first state, the anchor portions 102 104
have substantially the same cross sectional measurement as the
connecting portion 106. As illustrated in FIG. 3B, when the anchor
portions 102 104 assume the second state, they expand to a greater
size than the connecting portion 106. As discussed herein, the
anchor portions 102 104 may be constructed from a material similar
to that of the connecting portion 106 but having different
additives or structure to allow for expansion into the second
state. Alternatively, portions of the fastener 100 may be formed
from different materials and joined, or molded together to form the
composite fastener.
[0040] FIG. 3C illustrates another variation of a fastener 100 of
the present invention. In this variation, the fastener 100 includes
an insert 110. The insert 110 may comprise a bioabsorbable material
which dissolves/ is absorbed by the body at a slower rate than the
remainder of the fastener 100. Alternatively, the insert 110 may be
a nonbiodegradeable/non-bioabsorable material such that as tissue
replaces the absorbable fastener material, the insert remains to
provide long term retention of tissue. Moreover, the insert 110 may
comprise a metallic material to provide a radiopaque marker for
placement, or for subsequent location of the fastening site. Such a
combination may be used with absorbable and non-absorbable
fasteners. Although the insert 110 illustrated in FIG. 3C comprises
end portions having a larger dimension than the center portion, the
invention is not limited as such.
[0041] FIG. 4A-4C illustrate a basic example of a system 150 which
deploys fasteners 100 of the present invention. As shown in FIG.
4A, the system 150 includes a tubular member 152 that is
sufficiently flexible so that it may navigate tortuous passages to
access the surgical site yet it will have sufficient column
strength so that it may penetrate tissue to deploy the fastener
100. As such, variations of the tubular member 152 may be
reinforced to minimize kinking of the tubular member as it
navigates toward the surgical site. In this variation, the tubular
member 152 retains a fastener 100 in a lumen 154 that extends
between a proximal and distal end of the tubular member 152. The
fastener 100 is slidably located inside the tubular member 152 and
may be advanced using an advancing member 156 that is also slidably
located within the tubular member lumen 154.
[0042] It is contemplated that various methods known in the field
may be employed to advance/retract the advancing member. For
example, the advancing member may simply push the fastener using a
linear or rotary type drive system. Alternatively, the advancing
member may be an auger type system that advances the fastener with
the assistance of rotatable vanes within the tubular member. A
pneumatic, hydraulic, or fluid filled actuation may also be used to
advance/retract the advancing member. The advancing member 156 may
be a guidewire or other similar type device that is able to deploy
the fastener 100 at the operative site. Although not illustrated,
the fastener 100 may be removably attached to the advancing member
156 to improve accuracy in deployment of the fastener 100. In some
variations of the invention, the fastener 100 is configured
relative to the lumen 154 so that friction retains the fastener 100
within the lumen 154 until deployment of the fastener 100. In such
cases, the wall surface and/or diameter of the lumen 154 may be
selected to increase the sliding resistance of the fastener 100. In
any case, the system will be configured so that upon deployment of
the first anchor the fastener 100 will release from the device
rather than pulling out of the tissue.
[0043] The system 150 also includes a distal portion 158 located at
the distal end of the system 150. The distal portion 158 has a
distal tip 160 configured to pierce tissue and has an opening 162
through which the fastener 100 exits the device. In some variations
of the invention, the distal tip 160 is configured to prevent
"coring" of the tissue to minimize the size of any opening created
during deployment of the fastener. Instead, the tip 160
configuration has a sharpened area and a taper proximal to the
sharpened area so that the tip 160 makes a small puncture and then
dilates the opening in the tissue.
[0044] FIG. 4B illustrates the system 150 of FIG. 4A after the
distal portion 158 advances through two layers of tissue 1 and 2
and one anchor portion 102 exits from the system 150. As discussed
herein, the fastener 100 may expand upon exiting the system 150 via
being released from the constraint of the system 150.
Alternatively, or in combination, fluids (not shown) may cause the
fastener 100 to increase in size. Such fluids may be introduced
during the procedure or may be naturally occurring at the operative
site. Therefore, the fastener 100 may expands to a size greater
than the opening in tissue that is created by the fastening system
150. Next, the distal portion 158 and tubular member 152 are
retracted through the tissue 1. Once retracted, the system 150
deploys the second anchor portion (not illustrated) thereby
retaining the tissues 1 between the anchor portions 102 104.
[0045] FIG. 4C illustrates the system 150 of FIGS. 4A and 4B after
the distal portion 158 is withdrawn through the tissue 1
sufficiently enough so that the opening 162 is on the near side of
the tissue 1. Once in the appropriate position, the device 150
deploys the remaining anchor portion 104. It should be understood
that the system illustrated in FIGS. 4A-4C is depicted to show a
basic variation of the invention. It is contemplated that the
invention includes variations configured to first deploy an anchor
portion on a near side of the tissue (e.g., prior to insertion of
the distal tip into the tissue), then advance the distal tip into
the tissue to deploy the remaining anchor portion on the far side
of the tissue.
[0046] FIG. 4D illustrates a variation of a fastening system of the
present invention. In this variation, the distal tip 160 is
inserted into the distal portion 158.
[0047] Although the fastener of the present invention may be
delivered through any tubular device such as a cannula, a catheter,
polymeric tubing, etc., the fastener may be part of a fastening
system that permits deployment of the fastener in remote parts of
the body through a variety of minimally invasive procedures. In
such cases, the system may include a steerable catheter, or the
system may be guided to the site via a separate catheter, a
separate steerable catheter, a endoscope-type device, pre-shaped
catheter, etc.
[0048] FIGS. 5A-5B illustrate another variation of a system 150 of
the present invention. In this variation, the opening 162 is
located at a distal end of the device rather than in a side-wall of
the distal portion. In such a variation, the fastener 100 may be
located immediately adjacent the opening 162 to prevent the coring
of tissue as the distal tip 160 advances through tissue. FIG. 5B
illustrates a sectional view taken along the line 5B-5B of FIG. 5A.
As illustrated, the system 150 may include a lumen that is
appropriately shaped to orient the anchor and central portions of
the fastener 100. For example, the lumen may be extruded to form a
channel for the central portion. Additionally, as shown in FIG. 5B,
the system may include a multi-lumen design to allow for fluid
delivery ports 164 if required.
[0049] As discussed herein, upon deployment of the fastener 100
from the system 150, the fastener 100 portions shall increase in
size from the first state to a second state where the larger size
may be achieved by an increase in volume and/or profile a portion
of the fastener or the entire fastener. The invention contemplates
that the fastening delivery system 150 may be used to constrain the
fastener 100 into the first state, via a compression mechanism.
Alternatively, or in combination, the fastener 100 or portions of
the fastener may be configured to increase in size given the
application of a fluid. The fluid may comprise naturally occurring
bodily fluid or fluid delivered by the fastening system or even
fluid delivered via a separate device.
[0050] As discussed above, one of the functions of the inventive
tissue fastener is to retain two pieces of tissue together, retain
an implant to the tissue, or close an opening in tissue. The
feature of the inventive fastener 100 relating to expansion of the
anchor portions 102 104 permits placement of the fastener 100 using
an opening in the tissue that is smaller would otherwise be
required. Moreover, fasteners of the present invention may also be
configured such that the central portion 106 expands into a second
state as well. In such variations, expansion of the center portion
may allow for expedited healing of the opening in tissue, or for
closure and sealing of the opening in the tissue. In additional
variations of the invention, the central portion 106 may be
configured from a material that allows stretching of the center
portion 106 during deployment. As shown in FIG. 6A, such a fastener
100 having elastic properties allows for an increased compressive
force on the medium being retained between the fastener. An
additional benefit of such an elastic fastener is that the length
of the fastener 100 (e.g., as measured in a direction along the
central portion) can accommodate a greater range of tissue and/or
material thicknesses.
[0051] FIG. 7A illustrates a variation of a fastening system 150 of
the present invention. Although the system 150 depicts a single
fastener 100 located within the device, it is contemplated that the
system 150 may comprise a number of fasteners 100 to permit serial
deployment during use of the system. As illustrated, the system 150
includes a flexible tubular member 152 extending between having
proximal and distal ends and a lumen extending between the ends.
The system 150 includes a distal portion 158 the distal end of the
tubular member 152. It is contemplated that the distal portion 158
may comprise a separate material or insert that is coupled to the
tubular member 152. Alternatively, the distal portion 158 may be
formed from the same material as the tubular member 152. The distal
portion 158 includes a distal tip 160 for penetrating tissue
(and/or an implant, etc.). The distal portion 158 includes a lumen
that is in fluid communication with a lumen of the tubular member
152. The distal portion 158 also includes an opening 162 through
which the fastener 100 deploys.
[0052] In the illustrated variation, the opening 162 is located in
a side wall of the distal portion 158. However, as discussed
herein, the opening may be at the distal tip 160. It is
contemplated that the tubular member 152 will have sufficient
column strength to allow for penetration of tissue via advancement
of the system 150. Accordingly, the tubular member 152 may be
constructed of a material that provides sufficient flexibility and
column strength. Alternatively, the tubular member 152 may include
a reinforcing member 166, such as a coil, braid, or fiber
reinforcement. Furthermore, as discussed above, the system 150
includes an advancing member 156 that permits advancement and/or
deployment of the fastener 100. To improve advancement and
deployment of the fastener, the tubular member and/or advancing
member may be selected from materials that minimize the friction
between the two members. Alternatively, or in combination, these
items may include a lubricious coating to minimize friction.
Although not illustrated, the system 150 may include an additional
fluid delivery means, such as a fluid source where delivery of the
fluid occurs via the lumen of the device, an additional fluid
lumen, a separate catheter-type device for delivery of the fluid,
etc.
[0053] FIG. 7B illustrates an additional variation of a fastening
system 150 of the present invention. In this variation, the
fastener 100 is depicted as being partially ejected from the system
150. As shown, the distal portion 158 may include one or more fluid
delivery ports 170 in fluid communication with fluid delivery
lumen(s) 164 of the tubular member 152. FIG. 7C is a sectional view
taken along the lines of 7C-7C of FIG. 7B. As shown, the tubular
member 152 may include a channel 155 to aid in maintaining an
orientation of the fastener and/or assist in advancement of the
fastener. FIG. 7C also illustrates fluid delivery lumens 164 of the
tubular member 152. It is understood that the system may include a
single or multiple fluid delivery lumens(s).
[0054] FIG. 7D illustrates a variation of a fastening system of the
present invention 150 having a plurality of connected fasteners
100.
[0055] FIGS. 8A-8F illustrate variations of the fastening 150 of
the present invention having features that aid in dispensing
fasteners. FIGS. 8A-8C illustrate delivery systems having gate
members 168 of a valve-type configuration. For example, the gate
member 168 of these variations may comprise a flexible valve having
a slit, gap, or opening therein. The gate member will function to
impede movement of a portion of a surgical fastener from the
system. Accordingly, a portion of the gate member will interfere
with a portion of the fastener during its advancement in the system
or out of the system. Although the gate 168 is illustrated as being
placed in the opening 162 of the distal portion 158, the gate 168
may also be located within a lumen of the system. FIG. 8C
illustrates a variation of the fastening system 150 of the present
invention depicting a fastener 100 that is partially deployed from
the system 150.
[0056] FIGS. 8D-8E illustrate additional features of a fastening
system 150 of the present invention. The fastener and other
features of the system are omitted for the sake of clarity. In the
variation of FIG. 8D, the system 150 includes a gate member 168
located on a rotatable insert 170 located within the tubular member
152. The rotatable insert 170 may have the same or similar features
of the tubular member 152 and tubular member lumen as described
above. In use, rotation of the rotatable insert 170 causes the gate
member 168 (which may be formed by an opening in the rotatable
insert) to impinge upon a portion of the fastener (not shown) as
the fastener exits from the system 150. In some variations of the
invention, application of an increased torque to the gate member
170 may permit severing or cutting of the fastener or a connection
between adjacent fastener. For example, some variations of the
invention include fasteners that have a severable connection. FIG.
8E illustrates a variation of the fastening system 150 where a gate
member 168 is located on a distal end of a slidable insert 172. The
effect of the slidable insert 172 may be similar to that of the
rotatable insert described above where the operative mechanism is
advancement and retraction of the slidable insert. The slidable
insert 172 may move independently of any advancing member (not
shown) to allow proper dispensing of a fastener.
[0057] FIG. 8F illustrates another variation of a fastening system
of the present invention, in this variation the fastening system
150 may include an advancing member 156 that is coupled to a
fastener 100 via a detachable joint 172. The detachable joint 172
may comprise a low-melt temperature polymer that is bonded to both
the fastener 100 and the advancing member 156. In such a variation,
the advancing member 156 will be configured to heat the joint (for
example, via conductive, resistive, chemical, etc, means.)
Alternatively, the detachable joint 172 may comprise an
electrolytic joint. In such a case, the fastener may comprise a
metallic frame 110 as described above. In use, the fastener 100 may
be positioned, and upon confirmation of its placement, the
detachable joint 172 is activated to release the fastener.
* * * * *