U.S. patent application number 14/286142 was filed with the patent office on 2015-01-29 for expanding absorbable tack.
This patent application is currently assigned to Covidien LP. The applicant listed for this patent is Covidien LP. Invention is credited to Mark Russo.
Application Number | 20150032130 14/286142 |
Document ID | / |
Family ID | 51225313 |
Filed Date | 2015-01-29 |
United States Patent
Application |
20150032130 |
Kind Code |
A1 |
Russo; Mark |
January 29, 2015 |
EXPANDING ABSORBABLE TACK
Abstract
A surgical fastener is disclosed, and includes a head section
and a tissue snaring section. The head section includes an
engagement member pivotably disposed on an outer surface of the
head section. The tissue snaring section defines a longitudinal
axis and extends away from the head section. At least one helical
thread defined along an outer surface of the tissue snaring
section. The tissue snaring section is configured to rotate about
the longitudinal axis in a first radial direction, and the
engagement member is configured pivot outwardly from the head
section in the first radial direction.
Inventors: |
Russo; Mark; (Plantsville,
CT) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Covidien LP |
Mansfield |
MA |
US |
|
|
Assignee: |
Covidien LP
Mansfield
MA
|
Family ID: |
51225313 |
Appl. No.: |
14/286142 |
Filed: |
May 23, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61857709 |
Jul 24, 2013 |
|
|
|
Current U.S.
Class: |
606/139 ;
606/151 |
Current CPC
Class: |
A61F 2002/0072 20130101;
A61F 2/0063 20130101; A61B 17/064 20130101; A61B 17/068 20130101;
A61B 2017/0648 20130101 |
Class at
Publication: |
606/139 ;
606/151 |
International
Class: |
A61F 2/00 20060101
A61F002/00 |
Claims
1. A surgical fastener comprising: a head section including an
engagement member pivotably disposed on an outer surface of the
head section; and a tissue snaring section defining a longitudinal
axis and extending away from the head section, at least one helical
thread defined along an outer surface of the tissue snaring
section; wherein the tissue snaring section is configured to rotate
about the longitudinal axis in a first radial direction, and the
engagement member is configured pivot outwardly from the head
section in the first radial direction.
2. The surgical fastener of claim 1, wherein the head section
includes a threaded section.
3. The surgical fastener of claim 2, wherein the engagement member
is disposed radially adjacent the threaded section of the head
section.
4. The surgical fastener of claim 1, wherein the engagement member
is biased toward a radially outward position.
5. The surgical fastener of claim 1, wherein the engagement member
has an arcuate configuration.
6. A surgical fastener comprising: a head section including an
engagement member pivotably disposed on an outer surface of the
head section; and a tissue snaring section defining a longitudinal
axis and extending away from the head section, at least one helical
thread defined along an outer surface of the tissue snaring
section; wherein the engagement member is configured such that, in
a first condition of the surgical fastener, the engagement member
is disposed radially inward with respect to the outer surface of
the head section such that a first transverse head section diameter
is defined, and in a second condition of the surgical fastener, the
engagement member is disposed radially outward with respect to the
outer surface of the head section such that a different, second
transverse head section diameter is defined.
7. The surgical fastener of claim 6, wherein the head section
includes a threaded section.
8. The surgical fastener of claim 7, wherein the engagement member
is disposed radially adjacent the threaded section of the head
section.
9. The surgical fastener of claim 6, wherein the engagement member
is biased toward a radially outward position.
10. The surgical fastener of claim 6, wherein the engagement member
has an arcuate configuration.
11. The surgical fastener of claim 10, wherein, in the first
configuration, the arcuate configuration of the engagement member
approximates the curvature of a surface of the head section.
12. The surgical fastener of claim 6, wherein the engagement member
is configured to pivot between and including 0 degrees and 180
degrees.
13. The surgical fastener of claim 6, wherein the surgical fastener
is configured to be disposed within a delivery device, and, wherein
the surgical fastener is configured to be maintained in the first
condition by engagement with the delivery device.
14. A method of deploying a surgical fastener including a head
section including an engagement member pivotably disposed thereon
and a tissue snaring section extending away from the head section,
comprising: loading the surgical fastener in a delivery device such
that the engagement member of the head section is disposed in a
first, radially constrained configuration; and advancing the
surgical fastener out of the delivery device such that the
engagement member pivots radially outward with respect to the outer
surface of the head section in a second, deployed
configuration.
15. The method of claim 14, wherein the step of advancing the
surgical fastener includes actuating the delivery device.
16. The method of claim 14, further comprising the step of
advancing the surgical fastener through a mesh and into tissue such
that, in the deployed configuration, the mesh is compressed against
tissue.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of and priority to U.S.
Provisional Patent Application No. 61/857,709, filed Jul. 24, 2013,
the entire disclosure of which is incorporated by reference
herein.
BACKGROUND OF THE INVENTION
[0002] 1. Technical Field
[0003] The present disclosure relates to surgical fasteners, and
more particularly, to surgical features including an engagement
member and associated methods of applying.
[0004] 2. Description of Related Art
[0005] In hernias, such as direct or indirect inguinal hernias, a
part of the intestine protrudes through a defect in the support
abdominal wall to form a hernial sac. The defect may be repaired
using an open surgery procedure in which a relatively large
incision is made and the hernia is closed off outside the abdominal
wall by suturing. The mesh is attached with sutures over the
opening to provide reinforcement.
[0006] In contrast, minimally invasive, e.g., endoscopic or
laparoscopic, surgical procedures are currently available to repair
a hernia. In laparoscopic procedures, surgery is performed in the
abdomen through a small incision while in endoscopic procedures,
surgery is performed through narrow endoscopic tubes or cannulas
inserted through small incisions in the body.
[0007] Currently, minimally invasive surgical techniques for hernia
repair utilize surgical fasteners, e.g., surgical tacks, staples,
and clips, to secure the mesh to the tissue to provide
reinforcement to the repair and structure for encouraging tissue
ingrowth. Surgical fasteners may be deployed with a surgical
fastener applier through a mesh and into tissue below.
[0008] Challenges may be presented in affixing a mesh over a
hernial defect with surgical fasteners, e.g., in instances
involving irregular or uneven surface geometries, or in situations
when internal body structures are subject to movement and shifting.
However, it is desirable to minimize the number and size of
surgical fasteners deployed through a mesh to minimize trauma to
the tissue below. Accordingly, it would be desirable to provide a
surgical fastener that is configured with optimized mesh retention
properties, while minimizing the portion or size of the surgical
fastener inserted into tissue.
SUMMARY OF THE INVENTION
[0009] According to one aspect of the present disclosure, a
surgical fastener is disclosed, and includes a head section and a
tissue snaring section. The head section includes an engagement
member pivotably disposed on an outer surface of the head section.
The tissue snaring section defines a longitudinal axis and extends
away from the head section. At least one helical thread defined
along an outer surface of the tissue snaring section. The tissue
snaring section is configured to rotate about the longitudinal axis
in a first radial direction, and the engagement member is
configured pivot outwardly from the head section in the first
radial direction.
[0010] In one aspect of the present disclosure, the head section
includes a threaded section. The engagement member may be disposed
radially adjacent the threaded section of the head section. In
another aspect of the present disclosure, the engagement member is
biased toward a radially outward position. According to another
aspect of the present disclosure, the engagement member has an
arcuate configuration.
[0011] According to another aspect of the present disclosure, a
surgical fastener is disclosed, and includes a head section and a
tissue snaring section. The head section includes an engagement
member pivotably disposed on an outer surface of the head section.
The tissue snaring section defines a longitudinal axis and extends
away from the head section. At least one helical thread is defined
along an outer surface of the tissue snaring section. The
engagement member is configured such that, in a first condition of
the surgical fastener, the engagement member is disposed radially
inward with respect to the outer surface of the head section such
that a first transverse head section diameter is defined, and in a
second condition of the surgical fastener, the engagement member is
disposed radially outward with respect to the outer surface of the
head section such that a different, second transverse head section
diameter is defined.
[0012] In one aspect of the present disclosure, the head section
includes a threaded section. The engagement member may be disposed
radially adjacent the threaded section of the head section. In
another aspect of the present disclosure, the engagement member is
biased toward a radially outward position. According to another
aspect of the present disclosure, the engagement member has an
arcuate configuration. In the first configuration, the arcuate
configuration of the engagement member may approximate the
curvature of a surface of the head section.
[0013] According to another aspect of the present disclosure, the
engagement member is configured to pivot between and including 0
degrees and 180 degrees. In one aspect of the present disclosure,
the surgical fastener is configured to be disposed within a
delivery device, and is configured to be maintained in the first
condition by engagement with the delivery device.
[0014] According to another aspect of the present disclosure, a
method of deploying a surgical fastener including a head section
including an engagement member pivotably disposed thereon and a
tissue snaring section extending away from the head section is
disclosed. The method includes loading the surgical fastener in a
delivery device such that the engagement member of the head section
is disposed in a first, radially constrained configuration, and
advancing the surgical fastener out of the delivery device such
that the engagement member pivots radially outward with respect to
the outer surface of the head section in a second, deployed
configuration.
[0015] In another aspect of the present disclosure, the method
includes the step of advancing the surgical fastener includes
actuating the delivery device. According to another aspect of the
present disclosure, the method further includes further the step of
advancing the surgical fastener through a mesh and into tissue such
that, in the deployed configuration, the mesh is compressed against
tissue.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] Embodiments of the present disclosure will be appreciated by
reference to the drawings, wherein:
[0017] FIG. 1 is a side, perspective view of a surgical fastener
according to the present disclosure;
[0018] FIG. 2A is a top plan view of the surgical fastener of FIG.
1 in a first configuration;
[0019] FIG. 2B is a top plan view of the surgical fastener of FIG.
1 in a second configuration;
[0020] FIG. 3A is a bottom plan view of the surgical fastener of
FIG. 1 in the first configuration;
[0021] FIG. 3B is a bottom plan view of the surgical fastener of
FIG. 1 in the second configuration;
[0022] FIG. 4 is a side perspective view of the surgical fastener
of FIG. 1 shown transitioning between the first configuration and
the second configuration;
[0023] FIG. 5 is a side, cut-away view of a delivery device with
the surgical fastener of
[0024] FIG. 1 disposed therein;
[0025] FIG. 6 is a side, cut-away view of the delivery device of
FIG. 4 advancing the surgical fastener of FIG. 1 through a mesh and
into tissue; and
[0026] FIG. 7 is a top plan view of the surgical fastener deployed
into a mesh as shown in FIG. 6.
DETAILED DESCRIPTION
[0027] With reference now to the drawings wherein like numerals
represent like elements throughout the several views, the
presently-disclosed surgical fastener will be described. As used
herein, the term "operator" may refer to any user, e.g., a nurse,
doctor, or clinician, of the presently-disclosed surgical fastener.
Further, the term "distal" refers to that portion of the surgical
fastener, or component thereof, further from the operator while the
term "proximal" refers to that portion of the surgical fastener, or
component thereof, closer to the operator.
[0028] Referring initially to FIGS. 1, 2A, 2B, 3A, and 3B, a
surgical fastener 10 according to an embodiment of the present
disclosure is shown. Surgical fastener 10, as shown, may have a
substantially conical configuration and defines a longitudinal axis
"A." Surgical fastener 10 includes a head section 20 and a tissue
snaring section 40.
[0029] Head section 20 has a substantially flat, disc-like profile
that has a proximal surface 22a and a distal surface 22b. Head
section 20 defines a first transverse axis "B.sub.1" and a second
transverse axis "B.sub.2" that are each orthogonal to the
longitudinal axis "A" and to each other. Head section 20 comprises
two opposing threaded sections 24a, 24b disposed that protrude
radially outwardly from the head section 20. Opposing threaded
sections 24a, 24b may have a tapered configuration and include
threads 26a, 26b, respectively, that are configured for engagement
with portions of a delivery device (e.g., a surgical tacker
instrument), as will be described further below. A pair of radial
gaps 28a, 28b are defined between the threaded sections 24a, 24b of
head section 20, and may be positioned for engagement with other
portions of a delivery device, as will be described further
below.
[0030] A pair of engagement members 30a, 30b are disposed within
the respective radial gaps 28a, 28b of the head section 20.
Engagement members 30a, 30b are integrally formed with and extend
from head section 20 in a cantilevered fashion.
[0031] Engagement members 30a, 30b may have an arcuate profile, as
shown, and may lie substantially parallel to the proximal surface
22a of the head section 20. Engagement members 30a, 30b may be
disposed at a longitudinal position between the proximal surface
22a and the distal surface 22b of the head section 20. Engagement
members 30a, 30b are configured for pivotal movement with respect
to the head section 20. Engagement members 30a, 30b have a flexible
and/or resilient configuration, and accordingly may define a spring
constant. Engagement members 30a, 30b are biased toward a
radially-outward or cantilevered configuration, as will be
described further below. In some embodiments, engagement members
30a, 30b may include friction-enhancing features, e.g., grooves,
ridges, or spikes formed thereon. Additionally, engagement members
30a, 30b may be formed of a material sufficient to resist
deformation thereof
[0032] Engagement members 30a, 30b may be monolithically formed
with the outer surface of head section 20. In some embodiments,
engagement members 30a, 30b may be separable components that are
attached to the remainder of head section 20 via, e.g., brazing or
welding, a living hinge, or adhering.
[0033] In this manner, engagement members 30a, 30b are configured
to pivot and flex or swing radially outwardly with respect to the
remainder of head section 20. Turning to FIG. 4, the movement of
engagement members 30a, 30b allows surgical fastener 10 to
transition between a first, undeployed condition, in which
engagement members 30a, 30b are approximated radially-inwardly
toward the remainder of head section 20, and a second, deployed
configuration, in which engagement members 30a, 30b are disposed
radially outwardly with respect to the remainder of head section
20. As the engagement members 30a, 30b are disposed within the
respective radial gaps 28a, 28b, engagement members 30a, 30b may
define a radius of curvature that approximates the radius of
curvature defined by the outer surface of the head section 20
within the radial gaps 28a, 28b to accommodate folding into the
second, deployed configuration of surgical fastener 10.
[0034] The distal surface of head section 20 is formed onto the
proximal end 42 of tissue snaring section 40. Tissue snaring
section 40, as shown, may have a substantially conical profile that
tapers from its proximal end 42 to a distal tip 44. Tip 44 defines
a pointed surface that is configured for penetration of, e.g., a
mesh and/or tissue, as will be described further below. Tissue
snaring section 40 further includes a thread 46 formed therearound.
Tissue snaring section 40 may define a maximum diameter "D.sub.S"
(FIG. 3) that is less than an outer diameter "D.sub.H1" defined by
the head section 20, as shown. In this manner, head section 20 may
form a flanged surface protruding radially away from the proximal
end 42 of the tissue snaring section 40.
[0035] Thread 46 follows a generally helical, distally-downward
path along tissue snaring section 40. Thread 46 may have a first
terminus at the proximal end 42 of tissue snaring section 40, and
may have a second terminus at the distal tip 44 of tissue snaring
section 40. In some embodiments, thread 46 may have first and
second terminuses disposed between the proximal and distal ends 42,
44 of tissue snaring section 40. Thread 46 may have any desirable
configuration suitable for a surgical fastener, e.g., single-thread
or double-thread. Thread 46 may be formed onto the tissue snaring
section 40 by any suitable manner, e.g., etching or molding such
that the thread 46 is monolithically formed with the tissue snaring
section 40, or thread 46 may be attached to the tissue snaring
section 40 by adhesion, brazing, or welding.
[0036] It will be understood that surgical fastener 10 may have any
configuration suitable for its intended purpose. An exemplary
surgical fastener is disclosed in U.S. Patent Application
Publication No. 2011/0282401 to Corradi, et al., the entire
contents of which are incorporated by reference herein.
[0037] Turning now to FIG. 5, a distal portion of a delivery
device, generally designated as 100, is shown. Delivery device 100
may have any suitable configuration, such as a surgical fastener
applier or tacker instrument, to advance surgical fasteners 10
through a mesh "M" and into tissue "T" below. A suitable delivery
device is described in detail in U.S. Pat. No. 8,114,099 to Shipp,
the entire content of which is incorporated by reference
herein.
[0038] Delivery device 100 may include an outer tube portion 102
and a coil member 104 disposed therein. Coil member 104 is a
substantially resilient member that may have a flexibility profile
such that the outer tube portion 102 of the delivery device 100 is
biased to return to a resting position under a bending load. Coil
member 104 is fixedly disposed within the outer tube portion 102
and may be attached to the interior surface of outer tube portion
102 in any suitable manner, e.g., adhesion brazing or welding. Coil
member 104 includes a body 105 having a diameter "D" and being
disposed in a helically wound configuration that defines pitch
"P."
[0039] Surgical fastener 10 may be loaded into delivery device 100
in any suitable manner, e.g., a stack or column. The outer tube
portion 102 of delivery device 100 is dimensioned such that the
engagement members 30a, 30b are constrained in the first,
undeployed condition by the interior surface of the outer tube
portion 102. Successive winds of the coil member 104 are disposed
such that longitudinal spaces "S" are defined between adjacent
winds of the coil member 104. In this manner, the coil member 104
has a configuration such that the opposing threaded portions 24a,
24b of the surgical fastener 10 may be disposed within the spaces
"S" between adjacent winds of the body 105 of coil member 104.
[0040] Delivery device 100 may also include a pair of
radially-opposed tines 106a, 106b that extend longitudinally within
the interior of outer tube portion 102 to engage the surgical
fastener 10. Specifically, radially-opposed tines 106a, 106b are
dimensioned such that the each radially-opposed tine 106a, 106b may
be disposed within the respective gaps 28a, 28b defined between the
opposing threaded portions 24a, 24b of surgical fastener 10. (FIG.
1). Accordingly, the engagement members 30a, 30b of the surgical
fastener 10 disposed within the respective radial gaps 28a, 28b of
the surgical fastener 10 may be configured and arranged such that
the engagement members 30a, 30b are radially offset from the
opposing threaded portions 24a, 24b of the surgical fastener 10
such that a space is defined for the respective tines 106a, 106b to
extend therethrough.
[0041] In use, the delivery device 100 is actuated such that the
tines 106a, 106b rotate within the outer tube portion 102. As the
opposing threaded portions 24a, 24b of the surgical fastener 10 are
threadably engaged with the longitudinal spaces "S" defined by the
coil member 104, rotation of the tines 106a, 106b urges the
opposing threaded portions 24a, 24b to turn within the coil member
104 about the longitudinal axis "A" (FIG. 1), which causes distal
advancement of the surgical fastener 10 through the outer tube
portion 102 of delivery device 100 along a helical path defined by
the body 105 of coil member 104. As the surgical fastener 10
approaches the distal end of the delivery device 100, the tissue
snaring section 40 and distal tip 44 of the surgical fastener 10
protrude from the outer tube portion 102. Further engagement and
rotation by the tines 106a, 106b causes the surgical fastener 10 to
penetrate and advance through, e.g., mesh "M" and into tissue
"T."
[0042] Mesh "M" may be any suitable mesh material configured to
cover a desirable portion of tissue, e.g., a hernial defect. Tissue
"T" may be any external or internal section of tissue, e.g., an
abdominal wall.
[0043] Turning now to FIG. 7, deployment of the surgical fastener
10 will be described. Once the head section 20 of the surgical
fastener 10 advances past the distal end of the outer tube 102
(FIG. 5) of delivery device 100, the engagement members 30a, 30b
disposed between the opposing threaded head sections 24a, 24b are
free to flex radially outwardly. Accordingly, the engagement
members 30a, 30b pivot about their point of attachment to the head
section 20 of surgical fastener 10, and experience a degree of
rotation away from the head section 20. Each engagement member 30a,
30b may pivot through, e.g., between about 0 degrees and about 180
degrees measured from the point of attachment of each respective
engagement member 30a, 30b to the head section 20 of the surgical
fastener 10. Accordingly, from a top plan view of the surgical
fastener 10, each respective engagement member 30a, 30b may be
disposed in a respective first quadrant Q.sub.1 and third quadrant
Q.sub.3 measured along the pair of transverse axes "B.sub.1,"
"B.sub.2" defined along the proximal surface of head section 20 of
surgical fastener 10. Accordingly, each respective opposing
threaded section 24a, 24b may be disposed in a respective second
quadrant Q.sub.2 and fourth quadrant Q.sub.4. It will be understood
that surgical fastener 10 may have any configuration such that any
of the opposing threaded sections 24a, 24b or engagement members
30a, 30b may be disposed in any of quadrants Q.sub.1, Q.sub.2,
Q.sub.3, Q.sub.4.
[0044] Accordingly, as the engagement members 30a, 30b are deployed
radially outwardly with respect to the head section 20 of surgical
fastener 10, surgical fastener 10 transitions from the first,
undeployed condition, in which surgical fastener 10 defines a first
engagement area "A1" determined by the maximum outer diameter
"D.sub.H1"of the head section 20 of surgical fastener 10, and the
second, deployed condition, in which surgical fastener 10 defines a
second engagement area "A2" determined by the maximum outer
diameter "D.sub.H2" of the head section 20, measured between the
radially outward ends of the engagement members 30a, 30b.
[0045] With the engagement members 30a, 30b disposed radially
outwardly in the second, deployed configuration, a greater amount
of area of the mesh "M" is engaged by the surgical fastener 10 and
compressed against tissue "T." Accordingly, engagement members 30a,
30b facilitate the secure engagement of a mesh "M" against tissue
"T," and provide enhanced mesh retention properties, e.g., for
long-term use or to minimize disengagement of the surgical fastener
10 from the mesh "M" due to shifting of the tissue "T" or other
external loads applied to the surgical fastener 10, mesh "M," or
tissue "T." In this manner, the configuration of surgical fastener
10 provides optimal mesh retention properties such that a smaller
number of surgical fasteners 10 may be employed as compared to
surgical fasteners devoid of engagement members 30a, 30b. Further,
by providing the head section 20 of surgical fastener 10 with
engagement members 30a, 30b, optimal mesh retention properties are
provided without increasing the portion of the tissue snaring
section 40 inserted into the tissue "T."
[0046] It will be understood that various modifications may be made
to the embodiments disclosed herein. Therefore, the above
description should not be construed as limiting, but merely as
exemplifications of preferred embodiments. Those skilled in the art
will envision other modifications within the scope and spirit of
the claims appended thereto.
* * * * *