U.S. patent application number 13/345786 was filed with the patent office on 2012-05-03 for absorbable fastener and applying apparatus.
This patent application is currently assigned to Tyco Healthcare Group LP. Invention is credited to Kourosh Azarbarzin, Christopher J. Criscuolo, Russell S. Heinrich.
Application Number | 20120109157 13/345786 |
Document ID | / |
Family ID | 22915629 |
Filed Date | 2012-05-03 |
United States Patent
Application |
20120109157 |
Kind Code |
A1 |
Criscuolo; Christopher J. ;
et al. |
May 3, 2012 |
ABSORBABLE FASTENER AND APPLYING APPARATUS
Abstract
A surgical fastener apparatus, for securing a surgical mesh
material to body tissue including a pair of anchors each having
retaining means formed on an outer surface thereof; and a suture
tether interconnecting the pair of anchors to one another. The pair
of anchors having a substantially cylindrical body having a
conically tapered distal end and a planar proximal end. The
retaining means includes a series of semi-circular angled
projections having a planar proximal surface and a tapered distal
end, wherein a center of each of the angled projections is spaced a
distance from a longitudinal central axis of the body portion. The
surgical fastener is made from a bioabsorbable material which
reabsorbs into said body tissue at an appropriate rate, such as for
example, polyglycolic acid and polylactic acid.
Inventors: |
Criscuolo; Christopher J.;
(Branford, CT) ; Heinrich; Russell S.; (Hamden,
CT) ; Azarbarzin; Kourosh; (Fairfield, CT) |
Assignee: |
Tyco Healthcare Group LP
|
Family ID: |
22915629 |
Appl. No.: |
13/345786 |
Filed: |
January 9, 2012 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
12052071 |
Mar 20, 2008 |
8114101 |
|
|
13345786 |
|
|
|
|
10399486 |
Apr 16, 2003 |
|
|
|
PCT/US01/50165 |
Oct 23, 2001 |
|
|
|
12052071 |
|
|
|
|
60242647 |
Oct 23, 2000 |
|
|
|
Current U.S.
Class: |
606/139 ;
606/151 |
Current CPC
Class: |
A61B 2017/0646 20130101;
A61B 17/00234 20130101; A61B 17/0642 20130101; A61B 2017/0464
20130101; A61B 17/0401 20130101; A61B 2017/0427 20130101; A61B
17/8625 20130101; A61B 2017/0648 20130101; A61B 2017/00004
20130101; A61F 2/0063 20130101; A61B 17/0682 20130101; A61B 17/122
20130101; A61B 17/064 20130101; A61B 2017/0647 20130101; A61B
2017/0412 20130101; A61B 2017/044 20130101 |
Class at
Publication: |
606/139 ;
606/151 |
International
Class: |
A61B 17/10 20060101
A61B017/10; A61B 17/03 20060101 A61B017/03 |
Claims
1. A system for applying a surgical mesh material to a hernial
repair site during a hernia repair procedure, the system
comprising: a fastener applying device for firing a plurality of
surgical fasteners; the fastener applying device including: a
handle mechanism; an elongated body portion extending from the
handle mechanism; a series of surgical fasteners supported within
the elongated body portion in tip-to-tail fashion, each surgical
fastener including: a pair of anchors with each anchor defining a
longitudinal central axis and having retaining means formed on an
outer surface thereof, the respective retaining means each defining
a common central axis spaced a distance from the longitudinal
central axis; and a flexible joining member interconnecting said
pair of anchors to one another, wherein the pair of anchors are
oriented with respect to one another such that the common central
axes of the retaining means are disposed outward of the
longitudinal central axes; and a firing bar having first and second
tabs extending from a distal end thereof such that a longitudinal
axis of each tab is axially aligned with the common central axis of
a respective anchor of the pair of anchors, the firing bar being
operatively connected to the handle mechanism and being movable to
move the first and second tabs into engagement with the pair of
anchors of a distal-most surgical fastener of the series of
surgical fasteners to eject the distal-most surgical fastener from
a distal end of the elongated body portion into the hernial repair
site.
2. The system according to claim 1, wherein each of said pair of
anchors include a substantially cylindrical body portion having a
conically tapered distal end and a substantially planar proximal
end.
3. The system according to claim 2, wherein said retaining means
includes a series of angled projections having a tapered distal end
and a proximal surface that is angled with respect to the
longitudinal axis, wherein the common central axis of said series
of angled projections, for each anchor, is spaced a radial distance
from the longitudinal central axis of said respective anchor;
and
4. The system according to claim 2, wherein the flexible joining
member is a suture tether.
5. The system according to claim 3, wherein the series of angled
projections, for each anchor, is semi-circular.
6. The system according to claim 3, wherein the proximal surface of
each angled projection of each anchor is angled in such a manner so
as to define a partial thread on each anchor.
7. The system according to claim 2, wherein said flexible joining
member is operatively coupled to said substantially planar proximal
end of each of said pair of anchors.
8. The system according to claim 2, wherein each of said pair of
anchors has a length of approximately 3 mm from a distal tip of
said tapered distal end to said planar proximal end.
9. The system according to claim 2, wherein said pair of anchors
are made from a bioabsorbable material.
10. The system according to claim 9, wherein said bioabsorbable
material is selected from a material which reabsorbs into said body
tissue at an appropriate rate.
11. The system according to claim 10, wherein said bioabsorbable
material is selected from the group consisting of polyglycolic acid
and polylactic acid.
12. The system according to claim 10, wherein said pair of anchors
and said flexible joining member are dimensioned to be partially
absorbed into said body tissue for at least a period of
approximately 2 to 3 weeks immediately after implanting and are
fully absorbed into said body tissue at any time thereafter.
13. The system according to claim 2, wherein each of said pair of
anchors has a length of approximately 3 mm from a distal tip of
said tapered distal end to said planar proximal end.
14. The system according to claim 13, wherein each of said pair of
anchors has a diameter of approximately 1.5 mm.
15. The system according to claim 2, wherein said flexible joining
member is made from a bioabsorbable material.
16. The system according to claim 15, wherein said bioabsorbable
material is selected from the group consisting of polyglycolic acid
and polylactic acid.
Description
CROSS REFERENCE TO RELATED APPLICATION
[0001] The present application is a Continuation Application
claiming the benefit of and priority to U.S. Ser. No. 12/052,071,
filed Mar. 20, 2008, which is a Divisional Application claiming the
benefit of and priority to U.S. application Ser. No. 10/399,486,
filed on Apr. 16, 2003, which is a U.S. National Stage Application
claiming the benefit of and priority under 35 U.S.C. 371, to
International Application Ser. No. PCT/US01/50165, filed on Oct.
31, 2001, which claims the benefit of and priority to U.S.
Provisional Application Ser. No. 60/242,647, filed Oct. 23, 2000,
the entire contents of each of which is hereby incorporated by
reference.
BACKGROUND
[0002] 1. Technical Field
[0003] The present disclosure relates to a surgical fastener and to
an apparatus for applying the surgical fastener as well as to a
procedure for fastening objects to body tissue. More particularly,
the present disclosure relates to an absorbable surgical fastener
and apparatus for applying the absorbable fastener. In addition,
the present disclosure relates to procedures for fastening an
object to tissue and to procedures that require fastening of tissue
together.
[0004] 2. Background of Related Art
[0005] Fastening objects to body tissues is a commonly required
task in many different surgical applications. One illustrative
example of such an application is in hernia repair procedures
wherein a reinforcing synthetic mesh material is attached to the
tissue. A hernia is a general term referring to a protrusion of
tissue through a wall of a cavity in which the tissue is normally
contained, also called rupture. An inguinal hernia is a condition
in which a loop of intestine enters the inguinal canal (i.e., a
tubular passage through the lower layers of the abdominal wall). A
direct inguinal hernia creates a bulge in the groin area, and an
indirect hernia descends into the scrotum. In men, a hernia can
develop at the point where the spermatic cord passes out of the
abdomen into the scrotum. An inguinal hernia is a condition in
males which occurs in approximately 2% of the male population.
Often, an inguinal hernia can be pushed back into the abdominal
cavity. However, if the inguinal hernia cannot be forced back
through the abdominal wall, the herniated bowel may become trapped
in the inguinal ring and/or strangulated. If the flow of blood is
restricted (strangulated hernia) or the intestine is blocked
(obstructed), emergency surgery is necessary. Without treatment,
the strangulated loop of intestine dies as a result of a lack of
blood to the loop of intestine.
[0006] In order to treat the inguinal hernia, surgery is often
required to reposition the loop of intestine and secure the
weakened muscles in the abdomen. There are two primarily practiced
open surgical procedures for hernia repair which procedures use
reinforcing synthetic mesh. One procedure is the Lichentstein
anterior repair method and the other is the Stoppa pre-peritoneal
repair method. Modifications of these procedures exist, as do
additional open surgical procedures that do not require the
placement of reinforcing mesh over the hernia defect.
[0007] The Lichtenstein repair method is a "tension-free
hernioplasty" based on two important facts, namely, inguinal
hernias are caused by a metabolic disorder, which leads to a
progressive destruction of the fibroconnective tissue of the groin,
making the tissue unsuitable for use in hernia repair and the fact
that traditional tissue repairs are associated with undue tension
at the suture line, which leads to more postoperative pain, longer
recovery time, and a higher rate of.
[0008] The Lichtenstein repair method includes the following steps.
First, a transverse incision is made within a Langer's line,
beginning from the pubic tubercle. The external oblique aponeurosis
is opened and the spermatic cord with its cremasteric covering,
external spermatic vessels, and the genital nerve are freed from
the inguinal floor and lifted with a Penrose drain. The spermatic
cord is then dissected free from the pubic bone area medial to the
pubic tubercle in order to make room for extending the mesh beyond
the pubic tubercle.
[0009] Next, the external oblique aponeurosis is dissected from the
underlying internal oblique muscle and aponeurosis high enough to
make room for a prosthesis. The sac is then dissected from the cord
beyond its neck and inverted into the properitoneal space without
ligation or excision. The proximal end is closed, dissected away
from the cord structures, and inverted into the preperitoneal
space. The medial side of the mesh is then shaped to the patient's
anatomy. The first anchoring suture of the mesh fixes the mesh to
the anterior rectus sheath where it inserts into the pubic bone.
The lower edge of the mesh is sutured to the inguinal ligament
using the same suture in a continuous fashion and ends at the
lateral border of the internal ring. A slit is next made on the
lateral end of the mesh, creating 2 tails. The upper tail is then
passed under the cord and pulled toward the head of the patient,
placing the spermatic cord in between the 2 tails. The upper tail
is then crossed over the lower one and held with a pair of
hemostats. The tails are later sutured together and tucked under
the external oblique aponeurosis.
[0010] The Stoppa method of hernia repair places a single sheet of
prosthetic material (i.e., surgical mesh) between the peritoneum
and the musculopectineal orifice. The surgical mesh is then
anchored to Cooper's ligaments using nonabsorbable sutures. The
Stoppa hernia repair method is further described in the attached
article in Appendix A, the entire contents of which are hereby
incorporated by reference.
[0011] Yet another hernia repair method, known as TransAbdominal
PrePeritoneal (TAPP) Laparoscopic Hernia repair method, generally
includes the following steps. A pneumoperitoneum is created in the
abdomen and an intra-abdominal pressure is maintained. The repair
is then initiated. A laparoscope then inserted and is pointed
toward the afflicted inguinal canal. The peritoneal defect or
hernia is identified. A peritoneal incision is made, which incision
is extended from the lateral aspect of the inguinal region to the
lateral umbilical ligament. The Cooper's ligament is then exposed
as well as the inferior epigastric vessels and the spermatic Cord.
The indirect inguinal hernia sac is then dissected carefully from
the spermatic cord. A surgical mesh is then inserted into the
intra-abdominal cavity and deployed over the inguinal region. There
are three methods to place and secure the mesh over the inguinal
region. The mesh is then secured in place with a surgical stapler.
It is first stapled on to Cooper's ligament followed by placing
several staples perpendicular to the ligament followed by a row
more lateral and parallel to Cooper's Ligament. The graft is also
anchored around the inferior epigastric vessels and lateral to
them. If the mesh is wrapped around the spermatic cord, both limbs
of the mesh are stapled closed. The peritoneum is then closed using
additional staples and homeostasis is checked.
[0012] Yet another hernia repair method is known as Total
ExtraPeritoneal (TEP) Laparoscopic Hernia repair method. This
method is identical to the TAPP repair method, however, it entirely
takes place in the preperitoneal space. The TEP method includes the
following steps. Unlike the TAPP repair method, no pneumoperitoneum
is created in the TEP repair method. Instead, a small incision is
made below the umbilicus (midline) and the midline exposed. An
incision is made slightly lateral to the midline aponevrosis and
the anterior and posterior rectus muscle sheaths are exposed. The
anatomy must first be clearly identified. Cooper's ligament should
be first visualized as well as the inferior epigastric vessels. The
indirect hernia sac should be bluntly pulled away from the
spermatic cord and the inguinal canal. The hernia sac should then
be dissected as medially as possible to allow a surgical mesh to
cover the entire inguinal region. The mesh is then inserted and
stapled into place as in the TAPP repair method. With the repair
completed the small incisions can be closed.
[0013] The two most common of these methods are the Total
ExtraPeritoneal (TEP) repair method and the TransAbdominal
PrePeritoneal (TAPP) repair method. As discussed above, each of
these methods utilizes a reinforcing synthetic mesh that must be
fixed to the tissue to prevent early migration of the mesh away
from the hernia site. However, the mesh must be anchored into place
at first in order to prevent its movement from the hernia repair
sight. Only after 7-10 days, does the mesh have sufficient tissue
in-growth to prevent its motion away from the hernia repair
site.
[0014] Each of the above disclosed procedures utilizes titanium
staples to retain the mesh in place. These staples become permanent
residents in the body cavity. A disadvantage of permanent metal
staples is the possibility of the formation of excessive scar
tissue (adhesions) which can in turn cause further patient
complications and hinder future surgical procedures. In addition,
these permanent staples may be associated with increased long-term
discomfort to the patient as a result of the hernia repair
procedure.
[0015] Accordingly, a need exists for an improved surgical fastener
and applying apparatus as well as for methods in securing objects
to body tissue, for example such as in attaching a mesh material
for a sufficient time to a hernia repair site until sufficient
tissue in-growth occurs to retain the mesh in place.
SUMMARY
[0016] It is an object of the present disclosure to provide an
absorbable surgical fastener apparatus and methods in which the
amount of foreign material in the patients body is reduced, thereby
minimizing adhesion formation and reducing fastener-associated
long-term discomfort to the patient.
[0017] It is another object of the present disclosure to provide an
absorbable surgical fastener and method which is easier and faster
to use than traditional suturing techniques in open procedures.
Further, the relatively high firing force that can be applied to
the absorbable fasteners of the present disclosure facilitate more
reliable penetration of tougher tissue materials, such as for
example, Cooper's ligament.
[0018] It is yet another object of the present disclosure to
provide an absorbable surgical fastener which is radiolucent and
provides greater peace of mind for the patient.
[0019] It is still a further object of the present disclosure to
provide an absorbable surgical fastener apparatus having a suture
tether disposed between anchoring barbs. The tether provides the
advantage of holding the mesh in place loosely thus minimizing the
tension in the surrounding tissue and reducing fastener pull-out
occurrences.
[0020] It is another object of the present disclosure to provide a
surgical fastener apparatus which is dimensioned to not penetrate
the abdominal wall of the patient and which is provided with a
series of barbs having a relatively larger surface than standard
fastener barbs to thereby better retain the fastener in soft
tissue.
[0021] The presently disclosed surgical fastener apparatus and
method serve the function of previously used staples to secure
objects to body tissue as performed in previous methods, for
example, mesh being fixed to specific anatomic landmarks
surrounding the hernia repair, or attaching mesh to tissue, or
attaching tissue to tissue or attaching tissue to ligaments.
However, the presently disclosed absorbable fastener apparatus and
method have the uniquely advantageous feature that the absorbable
fasteners are utilized to attach the mesh to the tissue for a
sufficient time to allow tissue in-growth to occur on the mesh
material. In this manner, the absorbable fasteners help prevent
early mesh migration and then after sufficient tissue in-growth are
absorbed in the body.
[0022] A surgical fastener apparatus is provided for securing a
surgical mesh material to body tissue, in which the apparatus
includes a pair of anchors each having retaining means formed on an
outer surface thereof and a suture tether interconnecting said pair
of anchors to one another. The fastener apparatus is preferably
made from a bioabsorbable material and is dimensioned such that the
apparatus will only be partially absorbed over a period of 2 to 3
weeks after implantation and will be completely absorbed into the
body at any time thereafter.
[0023] In an alternate embodiment, the surgical fastener apparatus
includes a conical body portion having a pointed distal tip and an
enlarged proximal head. The conical body portion being provided
with a helical thread commencing at or near the distal tip and
terminating preferably at a distance spaced from the enlarged
proximal head.
[0024] In addition, a hernial repair method utilizing the fasteners
in accordance with the present disclosure is provided in which a
surgical mesh is secured in place over the hernia repair site by
imbedding the surgical fasteners in to body tissue through the
surgical mesh.
BRIEF DESCRIPTION OF THE DRAWINGS
[0025] Various embodiments of the presently disclosed surgical
fastener and methods will be described herein with reference to the
accompanying drawing figures wherein:
[0026] FIG. 1 is an enlarged perspective view of one embodiment of
an absorbable surgical fastener apparatus constructed in accordance
with the present disclosure;
[0027] FIG. 2 is a side view of a barb portion of the absorbable
surgical fastener apparatus of FIG. 1;
[0028] FIG. 2A is a side view of a barb portion of an absorbable
surgical fastener apparatus according to an alternate embodiment of
the present disclosure;
[0029] FIG. 3 is an enlarged perspective view of an alternative
embodiment of an absorbable surgical fastener in accordance with
the present disclosure;
[0030] FIG. 4 is an end view of the surgical fastener of FIG.
3;
[0031] FIG. 5 is an enlarged perspective view of an absorbable
surgical fastener apparatus including a pair of fasteners as shown
in FIG. 3;
[0032] FIG. 6 is a cross-sectional view of the absorbable fastener
shown in FIG. 5, taken along the longitudinal axis;
[0033] FIG. 7 is an illustration of a sequential step in one
embodiment of attaching an object to body tissue using the
presently disclosed absorbable surgical fasteners;
[0034] FIG. 8 is a further sequential step according to the method
embodiment of FIG. 7;
[0035] FIG. 9 is a still further sequential step of the method of
FIG. 7;
[0036] FIG. 10 is another sequential step of the method of FIG. 7;
and
[0037] FIG. 11 is another illustration of a step of the method
embodiment of FIG. 7.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0038] Preferred embodiments of the presently disclosed absorbable
surgical fastener apparatus and method of applying same will now be
described in detail with reference to the drawing figures wherein
like reference numerals identify similar or identical structural
elements.
[0039] The presently disclosed absorbable surgical fastener
apparatus and method is shown and described herein in connection
with open and laparoscopic inguinal, femoral and ventral hernia
repairs. Although not described in detail herein, the absorbable
fastener can also be applied to other procedures which require that
objects be attached to body tissue.
[0040] Referring initially to FIGS. 1 and 2, an absorbable surgical
fastener apparatus for connecting objects to body tissue, such as
absorbable fastener 10 includes dual fastener anchors 12 and 14
secured to one another by a suture tether 16 extending
therebetween. Each anchor 12 and 14 has a substantially cylindrical
body portion 18 having a conically tapered distal end 20 and a
substantially planar proximal end surface 22. Anchors 12 and 14 are
preferably provided with conically shaped distal ends 20 for easier
penetration of anchors 12 and 14 into hard tissues, such as, for
example, Cooper's ligament. While a generally conical distal end
has been disclosed, it is envisioned that other shaped ends (e.g.,
pyramid, and the like) can be provided. Each anchor 12 and 14 is
provided with a pair of opposed flattened side surfaces 22
extending longitudinally along the length thereof.
[0041] Anchors 12 and 14 are provided with barbs 12a,12b,12c, and
14a,14b,14c respectively to inhibit fastener pull-out occurrences
in either hard or soft tissue. Each barb is semi-circular having a
planar proximal surface 24 which is orthogonal to a central
longitudinal axis "A" of each anchor 12 and 14, and a tapered lower
surface 26. Preferably, barbs 12a-12c and 14a-14c share a common
central axis "B", however, it is envisioned that each respective
barb can have a different center as compared to other barbs on the
anchor. Preferably, central axis "B" is spaced a distance "X" from
longitudinal axis "A". In this manner, the center of barbs 12a-12c
and 14a-14c can be positioned to reveal a greater amount of planar
proximal surface 24 in order to provide an anchor with
predetermined anchoring and securing characteristics for body
tissue without compromising the strength of body portion 18 of each
anchor 12 and 14. For example, if greater retaining strength is
desired, distance "X" between central axis "B" and longitudinal
axis "A" is increased thereby forming a bard with a larger planar
proximal surface 24. In the case of securing a fastener to soft
tissue, as is the case in hernia repair, a fastener having a larger
projecting barb is desired in order to better anchor the fastener
into the soft tissue of the patient.
[0042] While each barb 12a-12c and 14a-14c is orthogonal to
longitudinal axis "A" of each anchor 12 and 14 respectively, as
seen in FIG. 2A, it is envisioned that each barb can be angled
relative to longitudinal axis "A" such that barbs 12a, 12b and 12c
form a partial thread around body portion 18 of each anchor 12 and
14. In this manner, as each anchor 12 and 14 is pressed into body
tissue, each anchor 12 and 14 will rotate into the body tissue.
[0043] Although the embodiment of FIGS. 1 and 2 illustrate barbs
formed partially around the circumference of anchors 12 and 14,
multiple barb configurations can be utilized and are within the
scope of the present disclosure. For example, in addition to the
illustrated configuration, single barb, circumferential barb (i.e.,
barbs encircling the entire anchor), sharp barbs, dull barbs,
multiple barbs, and various geometrically shaped barbs may be
utilized.
[0044] While a planar proximal end 20 has been shown, it is
envisioned that each anchor 12 and 14 can be provided with a notch
or detent (not shown) formed in the proximal end thereof. In this
manner, when a series of absorbable fasteners 10 are joined
together, the tapered distal ends 18 are received in the detents to
thereby maintain the absorbable fasteners 10 and anchors 12 and 14
longitudinally aligned with one another.
[0045] Absorbable fasteners 10 are preferably made of medical grade
absorbable materials, for example, Polyglycolic Acid (PGA) and
Polylactic Acid (PLA). A critical feature of the presently
disclosed absorbable fastener is that the absorbable fastener
provide sufficient strength to retain a mesh material in place for
a desired period of time. For example, in the case of applying a
hernia repair mesh material, it is recommended that absorbable
fasteners 10 remain in place retaining the mesh material for
approximately 2-3 weeks and be absorbed into the body tissue
anytime after that.
[0046] It is preferred that absorbable fasteners 10 are
approximately 3 mm long, from the tip of distal end 18 to proximal
end 20, by approximately 1.5 mm in diameter. Other suitably
configured and dimensioned fasteners may also be utilized depending
on the particular application. It is also preferred that absorbable
fasteners 10 are configured and dimensioned to avoid penetrating
too far into the tissue. An example of a similar fastener structure
and an instrument for applying such fasteners are disclosed in U.S.
Pat. No. 5,997,552 (hereinafter "the '552 patent"), issued to
Person et al. and entitled Meniscle Fastener Applying Device, the
entire contents of which are hereby incorporated by reference.
Unlike the fastener in the '552 patent, the barbs of fastener 10
according to the present disclosure have a center "B" which is
spaced a distance "X" from the longitudinal axis "A" of the anchor
as opposed to the body of the anchor being cut away to reveal a
barb in the '552 patent. In this manner, a barb having a larger
height is achieved without altering the dimensions of the body
portion, which larger height more firmly secures the anchor of
fastener 10 into body tissue as compared to the fastener disclosed
in the '552 patent.
[0047] Unlike the applicator instrument for placing absorbable
fasteners 10 disclosed in U.S. Pat. No. 5,997,552, previously
incorporated by reference herein, the applicator according to the
present disclosure is preferably adapted to fire 20 to 30 fasteners
per instrument for use in either open and/or laparoscopic
procedures. It is envisioned that the applicator instrument be
either entirely disposable after use or be provided with a
replaceable cartridge of fasteners which can be coupled to the end
of a reusable applicator and replaced within a given procedure
while the handle of such an applicator would still be disposable
but would be reusable within a single procedure. While an alternate
applier may be used, the fastener applier disclosed in the '552
reference can be used to apply the surgical fasteners disclosed
herein.
[0048] By way of example, the general procedure of applying a mesh
material during a hernia repair procedure, is to first create an
access to the location of the hernia (i.e., incision and
dissection) thereby exposing the hernia; then place a prosthetic
mesh over the hernia defect; next fasten the mesh to the
surrounding tissue by firing a plurality of absorbable fasteners 10
through the mesh and into tissue to thereby secure the mesh into
place; and finally close the access wound.
[0049] Turning now to FIGS. 3-5, an alternative embodiment of a
surgical fastener in accordance with the present disclosure in
shown generally as 200. As seen in FIGS. 3 and 4, fastener 200
includes a substantially conical body portion 202 depending from a
circular head portion 204. Conical body portion 202 includes a
helical thread 206 commencing at a pointed distal tip 208 of body
portion 202 and terminating at a distance spaced from head portion
204. As the helical thread 206 advances from distal tip 206 toward
head portion 204, the radial projection of the helical thread 206
from the body portion 202 increases. While the helical thread 206
is disclosed as commencing at the distal tip 208, it is envisioned
that the helical thread 206 can commence at a distance spaced from
the distal tip 208. In addition, head portion 204 can be provided
with a recess or notch (not shown) formed in the center of the
proximal surface thereof. The recess being configured to receive
the distal tip 208 of an adjacent fastener 200 therein. In this
manner, a series of fasteners 200 can be aligned in a tip-to-tail
fashion with one another and share a common axis.
[0050] In use, fastener 200 is pressed into body tissue "T",
through surgical mesh "M", until the entire body portion 202 of
fastener 200 has passed through mesh "M" and has been buried in
tissue "T". Head portion 204 ensures that fastener 200 does not
completely pass through mesh "M" thereby ensuring that mesh "M" is
in contact with tissue "T". Fastener 200 includes an arcuate tooth
210 projecting radially outwardly from the proximal end of helical
thread 206 and oriented such that the curve of the arcuate tooth
210 is oriented to inhibit a rotation of fastener 200 which would
remove fastener 200 from body tissue "T".
[0051] Turning now to FIG. 5, a surgical fastener apparatus
according to the present disclosure is shown generally as 300.
Similar to fastener 200, surgical fastener apparatus 300 includes a
pair of substantially conical anchors 302 each having a helical
thread 304 commencing at a distal tip 306 of each anchor 302 and
terminating at a proximal end surface 308 of each anchor 302. Once
again, the radial projection of the helical thread 304 on anchor
302 increases as the helical thread 304 advances from the distal
tip 306 to the proximal end of the anchor 302. While the helical
thread 304 is disclosed as commencing the distal tip 306, it is
envisioned that the helical thread 304 can commence at a distance
spaced from the distal tip 306 just as well. Anchors 302 are
connected to one another by a suture tether 310 extending
therebetween. As seen in FIG. 5, the orientation of helical thread
304 on each anchor 302 is in the same direction. In this manner, as
anchors 302 are being imbedded into body tissue and commence
rotating in the direction of helical thread 304, suture tether 310
on each anchor 302 will rotate in the same direction and not become
tightened. The proximal end of each helical thread is provided with
an arcuate tooth 312, which arcuate tooth 312 is oriented such that
after anchors 302 have been completely imbedded into the body
tissue the tooth 312 will dig into the body tissue if the anchor is
rotated in a direction which would remove the anchor from the body
tissue. Similar to fastener 10, surgical fastener apparatus 300 can
be provided with a detent or recess 314 (see FIG. 6) formed in the
proximal end surface thereof. In this manner, a series of fasteners
300 can be aligned in tip-to-tail fashion with one another in a
fastener applier so that fasteners 300 share a common axis.
[0052] As seen in FIG. 6, helical thread 304 is made up of a distal
surface 316 and a proximal surface 318 joined together to form a
sharp edge 320. In addition, suture tether 310 is fixedly retained
within anchors 302, however, it is envisioned that suture tether
310 can be rotatably mounted to proximal surface 308.
[0053] Fasteners 200 and 300 are also preferably made of medical
grade absorbable materials, for example, Polyglycolic Acid (PGA)
and Polylactic Acid (PLA). A critical feature of the presently
disclosed absorbable fastener is that the absorbable fastener
provide sufficient strength to retain a mesh material in place for
a desired period of time. For example, in the case of applying a
hernia repair mesh material, it is recommended that absorbable
fasteners 200 or 300 remain in place retaining the mesh material
for approximately 2-3 weeks and be absorbed into the body tissue
anytime after that. In addition, it is preferred that absorbable
fastener 200 and that each anchor of fastener apparatus 300 are
approximately 3 mm long, from the tip of distal end to the proximal
end, and wherein the proximal end is approximately 1.5 mm in
diameter. It is preferred that fastener 200 and fastener apparatus
300 are configured and dimensioned to avoid penetrating too far
into the body tissue.
[0054] Fasteners 200 and 300 can be imbedded into body tissue by
either pressing the fastener in to the tissue and allowing the
thread on the fastener to automatically twist the fastener into the
tissue, by providing a twisting applier which turns the fastener
and thus the helical threads draw the fastener into the body tissue
or by a combination of pressing and twisting.
[0055] By way of example only, and not to be considered limiting in
any way, with reference to FIGS. 7-11, a Lichtenstein repair method
will now be described as performed using any of the absorbable
surgical fasteners in accordance with the present disclosure.
First, a 5 cm to 6 cm transverse incision is made within a Langer's
line, beginning from the pubic tubercle. The external oblique
aponeurosis ("EOA") is opened. As shown in FIG. 7, the spermatic
cord ("SC") with its cremasteric covering, external spermatic
vessels, and the genital nerve are freed from the inguinal floor
and lifted with a Penrose drain. The spermatic cord ("SC") is
dissected free from the pubic bone area for approximately 2 cm
medial to the pubic tubercle in order to make room for extending a
prosthetic mesh beyond the pubic tubercle. The external oblique
aponeurosis ("EOA") is dissected from the underlying internal
oblique muscle and aponeurosis ("IOM") high enough to make room for
a prosthesis that is 6 cm to 7 cm in height. The sac is then
dissected from the spermatic cord ("SC") beyond its neck and
inverted into the properitoneal space without ligation or
excision.
[0056] Referring to FIG. 8, a medial side of the mesh ("M"), is
shaped to the patient's anatomy. A first absorbable fastener 10,
200 or 300 is applied to the mesh to fix the mesh to the anterior
rectus sheath where it inserts into the pubic bone. The absorbable
fastener 10, 200 or 300 is placed approximately 2 cm medial to the
pubic tubercle in order to be sure that the area is covered by the
mesh ("M"). Additional absorbable fasteners 10, 200 or 300 are
placed therearound and end at the lateral border of the internal
ring. The lower edge of the mesh ("M") is then anchored to the
inguinal ligament using the same fasteners 10, 200 or 300 around
the surgical mesh ("M") and ending at the lateral border of the
internal ring.
[0057] According to one method of the present disclosure, the
absorbable fastener 10, 200 or 300 is secured into place by firing
the fastener into the body tissue such that a first anchor of the
surgical fastener penetrates through the surgical mesh and into the
body tissue and such that a second anchor of the surgical fastener
is implanted directly into the body tissue. In this manner, the
suture tether 16, 310 (see FIGS. 1, 2, 5 and 6) of the fastener
apparatus extends partially across the surgical mesh and partially
across body tissue. In an alternative method, an absorbable
fastener in accordance with the present disclosure, can be secured
into place such that both anchors are imbedded into the body tissue
and pass through the surgical mesh. If fastener 200 is used in the
method, fasteners 200 are anchored into the body tissue solely
through the mesh.
[0058] A slit is then made on the lateral end of the mesh ("M"), as
seen in FIG. 9, creating 2 tails--2/3 ("T1") above and 1/3 below
("T2"). The upper tail ("T1") is then passed under the cord ("SC")
and pulled toward the head of the patient, placing the spermatic
cord ("SC") in between the 2 tails (T1, T2"). The upper tail ("T1")
is then crossed over the lower one ("T2") and held with a pair of
hemostat ("H"), as seen in FIG. 10. The tails ("T1, T2") are later
sutured together and tucked under the external oblique aponeurosis,
leaving 5 cm to 6 cm of mesh lateral to the internal ring.
[0059] While the upper edge of the mesh is fixed in place, care is
taken to keep the mesh slightly relaxed. This laxity produces a
dome-like ripple in the mesh to compensate for increased
intra-abdominal pressure when the patient stands up from his or her
recumbent position during the operation. If the mesh is kept
completely flat, it becomes subject to tension when the patient
stands up. This pulling effect on the mesh ("M") and the tissue, is
illustrated when the mesh ("M") is kept flat as shown in FIG. 11.
The use of a surgical fastener in accordance with the present
disclosure effectively eliminates the tension of the surgical mesh
since the anchors of the surgical fastener are relatively movable
with respect to one another. In other words, one anchor is able to
move with respect to the other anchor if needed as the patients
body tissue shifts. In so doing, the tension on the mesh is reduced
since the suture tether provides the mesh with some room to move
since the individual anchors are moveable with respect to one
another.
[0060] A Total ExtraPeritoneal Laparoscopic Hernia repair using
fasteners 10 or 300, in accordance with the present disclosure,
will now be described. First, a skin incision is created and the
fascia is incised. A balloon type distractor is then placed therein
and distended in order to create an operative extraperitoneal
space. Umbilical trocars and secondary trocars are then inserted
into the extraperitoneal space and the space explored. The medial
and lateral structures are then dissected and the spermatic chord
identified. A surgical mesh is then cut to the desired size and
shape such that a slit is provided in order to wrap the mesh on
either side of the spermatic chord. The mesh is then laterally
fixed in place using surgical fasteners 10, 200 or 300 in order to
anchor the mesh to the tranversus arch and the iliopubic tract.
This step is repeated for the opposite side. The mesh is then
medially fixed in place using additional fasteners 10, 200 or 300
to the transversus arch and to Cooper's ligament or in the
alternative, fix the mesh to the medial iliopubic tract. Finally,
the incision is closed.
[0061] It is envisioned that fasteners 10, 200 or 300 can be used
in a TAPP repair method to replace suturing of the mesh both
laterally and medially. In the TAPP repair method, fasteners 10,
200 or 300 are used to secure the mesh in to place by penetrating
the mesh and being anchored into the body tissue.
[0062] While each of the above described fasteners have been
described as being used in connection with hernial repair surgery,
it is envisioned that fasteners having a similar structure can be
used in surgical procedures for fastening items to bone or
cartilage. In such surgical procedures, the surgical fasteners can
be made from surgical grade stainless steel, titanium or any other
surgical grade material having sufficient strength to penetrate
bone.
[0063] It will be understood that various modifications may be made
to the embodiments of the presently disclosed surgical absorbable
fastener apparatus and methods 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 present disclosure.
* * * * *