U.S. patent application number 12/849956 was filed with the patent office on 2010-11-25 for self-retaining wound closure device including an anchoring loop.
This patent application is currently assigned to QUILL MEDICAL, INC.. Invention is credited to Stanton D. Batchelor, Andrew Kaplan, Jeffrey C. Leung, Matthew A. Megaro, Gregory L. Ruff.
Application Number | 20100298871 12/849956 |
Document ID | / |
Family ID | 35428804 |
Filed Date | 2010-11-25 |
United States Patent
Application |
20100298871 |
Kind Code |
A1 |
Ruff; Gregory L. ; et
al. |
November 25, 2010 |
SELF-RETAINING WOUND CLOSURE DEVICE INCLUDING AN ANCHORING LOOP
Abstract
A self-retaining suture includes a plurality of tissue retainers
which allow deployment in a deployment direction, but prevent
movement in the opposite direction. The self-retaining suture has a
needle at the proximal end and a tissue anchor at the distal end.
The tissue anchor includes a curved portion of the suture formed
into a loop which anchors the suture in the tissue. Additionally,
the suture can be passed through a tissue and then passed through
the loop to secure the distal end of the suture to the tissue.
Inventors: |
Ruff; Gregory L.; (Chapel
Hill, NC) ; Leung; Jeffrey C.; (Raleigh, NC) ;
Kaplan; Andrew; (Hillsborough, NC) ; Megaro; Matthew
A.; (Chapel Hill, NC) ; Batchelor; Stanton D.;
(Holly Springs, NC) |
Correspondence
Address: |
ANGIOTECH
P. O. BOX 2840
NORTH BEND
WA
98045
US
|
Assignee: |
QUILL MEDICAL, INC.
|
Family ID: |
35428804 |
Appl. No.: |
12/849956 |
Filed: |
August 4, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10908539 |
May 16, 2005 |
|
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12849956 |
|
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60521528 |
May 14, 2004 |
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Current U.S.
Class: |
606/222 ;
606/228; 606/230; 606/232 |
Current CPC
Class: |
A61B 2017/06171
20130101; A61B 2017/0417 20130101; A61B 2017/0412 20130101; A61B
2017/06176 20130101; A61B 2017/0464 20130101; A61B 17/11 20130101;
A61B 17/064 20130101; A61B 17/0401 20130101; A61B 17/06166
20130101; A61B 17/06 20130101; A61B 17/1146 20130101; A61B
2017/00761 20130101; A61B 2017/06057 20130101; A61B 2017/0462
20130101; A61B 17/04 20130101 |
Class at
Publication: |
606/222 ;
606/232; 606/228; 606/230 |
International
Class: |
A61L 17/12 20060101
A61L017/12; A61B 17/04 20060101 A61B017/04; A61B 17/06 20060101
A61B017/06 |
Claims
1. A wound closure device comprising: a needle; a polymer suture
filament having a first end from which the needle extends, and a
second end; a plurality of cuts made into a first portion of the
polymer suture filament adjacent the first end; the plurality of
cuts defining a plurality of tissue engaging elements distributed
along the first portion of the polymer suture filament; said tissue
engaging elements being adapted to permit movement of the first
portion of the polymer suture filament through tissue towards the
first end, and prevent movement of the first portion of the polymer
suture filament through tissue towards the second end; a second
portion of the polymer suture filament adjacent the second end
being formed into a loop; and the loop having diameter such that
the tissue engaging elements can pass through the loop without
engaging the loop.
2. The wound closure device of claim 1, wherein said needle is a
metal needle attached to the first end of the polymer suture
filament.
3. The wound closure device of claim 1, wherein said second end of
the polymer suture filament is attached to the second portion of
the polymer suture filament at a position spaced from the second
end to form said loop.
4. The wound closure device of claim 1, wherein the second end is
joined to the second portion of the polymer suture filament to form
the loop.
5. The wound closure device of claim 1, wherein the first portion
of the polymer suture filament lies within the loop.
6. The wound closure device of claim 1, wherein: the second portion
of the polymer suture filament lies within tissue; and the first
portion of the polymer suture filament lies within the loop;
thereby anchoring the second portion of the polymer suture filament
to said tissue.
7. The wound closure device of claim 1, wherein said loop is devoid
of tissue engaging elements.
8. The wound closure device of claim 1, wherein said second portion
of the polymer suture filament is devoid of tissue engaging
elements.
9. The wound closure device of claim 1, wherein said
tissue-retainers are distributed at about 120 degree intervals
around said polymer suture filament.
10. The wound closure device of claim 1, wherein said
tissue-retainers are evenly distributed at intervals around said
polymer suture filament.
11. The wound closure device of claim 1, wherein the polymer suture
filament is made of a bio-absorbable polymer.
12. The wound closure device of claim 1, wherein the polymer suture
filament is formed of a copolymer comprising trimethylene
carbonate.
13. The wound closure device of claim 1, wherein the polymer suture
filament is formed of a copolymer comprising glycolide.
14. The wound closure device of claim 1, wherein the polymer suture
filament is formed of a copolymer of gylcolide and trimethylene
carbonate.
15. The wound closure device of claim 1, wherein the polymer suture
filament is formed of a copolymer comprising one or more of
caprolactone, polydioxanone, and polylactide.
16. The wound closure device of claim 1, wherein the tissue
engaging elements are barbs.
17. A wound closure device comprising: a flexible strand having a
first portion and a second portion; a needle extending from the
first portion; a plurality of tissue engaging elements extending
from the first portion of the flexible strand, said tissue engaging
elements being directed away from the needle and extended away from
said flexible strand; wherein said plurality of tissue engaging
elements permit movement of the flexible strand through tissue
towards the needle and prevents movement of the flexible strand
through tissue in an opposite direction; wherein said second
portion of the flexible strand ends in a loop; and wherein said
second portion of the flexible strand is positioned within the
loop.
18. The wound closure device of claim 17, wherein the second
portion of said flexible strand is connected to itself to form said
loop.
19. A suture comprising: a first pointed end; an elongated body
having a second end; the first pointed end extending from said
elongated body; said elongated body including a strand of
bio-absorbable polymer; a plurality of tissue engaging elements
formed in said elongated body and extending from the periphery of
the elongated body; said tissue engaging elements configured to
permit movement of the elongated body through tissue in a direction
of movement of said first pointed end by yielding toward the
elongated body and, and said tissue engaging elements configured to
prevent movement in a direction opposite the direction of movement
of the first pointed end by engaging tissue; wherein said second
end of the elongated body forms an anchor adapted to secure the
second end to tissue; and wherein said anchor has a curved portion
of the elongated body formed into a loop.
20. The wound closure device of claim 19, wherein the tissue
engaging elements are barbs.
Description
CLAIM TO PRIORITY
[0001] This application is a continuation of U.S. application Ser.
No. 10/908,539, filed May 16, 2005, now pending; which claims the
benefit under 35 U.S.C. 119(e) of U.S. Provisional Application No.
60/521,528, filed May 14, 2004, which applications are incorporated
herein by reference in their entireties.
BACKGROUND OF THE INVENTION
[0002] The present invention relates generally to methods and
devices for joining or positioning bodily tissue in surgical
applications and wound repair, and more particularly to a surgical
suturing method and devices for joining or positioning bodily
tissue using a suture having a plurality of barbs that permit the
suture to be pulled through the tissue in one direction but resist
movement of the suture relative to the tissue in the opposite
direction.
[0003] Single-directional barbed sutures have a plurality of barbs
that permit the suture to be pulled through tissue in one
direction, but resist movement of the suture in the tissue in the
opposite direction. Such sutures may have one end that is pointed
to allow penetration and passage through tissue in the one
direction and another end that is an anchor which engages the
tissue at the initial insertion point to prevent further movement
in the one direction. Bi-directional barbed sutures may have barbs
extending in one direction at one end and opposing barbs at the
other end, preventing movement of the suture through tissue in
either direction between two pointed ends.
[0004] Methods for placement of barbed sutures in tissue include,
but are not limited to, straight, zigzag, and curvilinear patterns
such as alpha, sinusoidal, and corkscrew. In general such patterns
terminate in an alignment coincident with the pattern, meaning, for
example, that a straight pattern terminates along a straight path,
a sinusoidal pattern terminates along a sinusoidal path, and so
forth.
[0005] Barbed sutures may be used to approximate tissue adjacent to
a wound or a tissue separation, or to position and support tissue
where there is no wound in procedures such as cosmetic surgery.
SUMMARY OF THE INVENTION
[0006] According to the present invention a barbed suture is
provided including an elongated body, one pointed end, a plurality
of barbs extending from the periphery of the body, and one end
having an anchor. The barbs permit movement of the suture through
the tissue in the direction of movement of the pointed end and
prevent movement of the suture in a direction opposite the
direction of movement of the pointed end. The anchor includes at
least one arcuate limb extending outside the periphery of the body
to a greater degree than the barbs, and prevents movement of the
suture in the direction of movement of the pointed end. A variety
of anchor designs are provided, including but not limited to
anchors with arcuate limbs evenly or unevenly spaced around the
body and with equal or differing lengths, with or without segments
attached. The anchors may, for example, collapse, have a hook
shape, clip shape, "T" shape with segments mounted to the "T", a
harpoon end, a loop end, hemispherical shape, coneflower shape, or
the shape of an "M".
[0007] Also according to the present invention is a method of
placing a barbed suture in bodily tissue. The suture includes at
least one pointed end and a central portion having barbs that allow
movement of the suture in the direction of movement of the pointed
end and resist movement of the suture away from the direction of
movement of the pointed end. The method includes inserting the
pointed end of the suture in the tissue, and then advancing the
suture through the tissue such that the central portion is disposed
along a first path. The suture deviates from the first path
proximate to the at least one pointed end of the suture along a
second path, and the second path forms an angle with the projected
first path, had the suture remained on the first path, of at least
approximately 30 degrees.
[0008] Further according to the present invention, a method of
placing a barbed suture in bodily tissue to approximate tissue on
each side of a wound is provided. The suture includes at least one
pointed end and a central portion having barbs that allow movement
of the suture in the direction of movement of the pointed end and
resist movement of the suture away from the direction of movement
of the pointed end. The method includes inserting the pointed end
of the suture in the tissue and then advancing the suture through
the tissue along a first path. Then the suture deviates from the
first path to follow a second path generally disposed laterally
away from the wound. The suture further deviates from the second
path proximate to the at least one pointed end of the suture along
a third path, and the third path forms an angle with the projected
second path, had the suture remained on the second path, of at
least approximately 30 degrees.
[0009] Yet further in accordance with the present invention, a
method of placing a single-directional barbed suture in bodily
tissue to approximate a wound is provided. The suture includes an
elongated body, one pointed end, one end terminating in an anchor,
and a plurality of barbs extending from the periphery of the body.
The anchor extends outside the periphery of the body to a greater
degree than the barbs. The barbs permit movement of the suture
through the tissue in the direction of movement of the pointed end
and prevent movement of the suture in a direction opposite the
direction of movement of the pointed end. The anchor prevents
movement of the suture in the direction of movement of the pointed
end. The method includes inserting the pointed end of the suture
into one face of the wound and advancing the suture through the
tissue until the anchor achieves adequate holding strength in the
tissue to resist further movement in the tissue, leaving the anchor
embedded in the tissue.
[0010] Also in accordance with the present invention, a method of
placing a single-directional suture in tissue using an insertion
device is provided. The suture includes an elongated body, one
pointed end, one end terminating in an anchor, and a plurality of
barbs extending from the periphery of the body. The anchor, when
extended, extends outside the periphery of the body to a greater
degree than the barbs. The barbs permit movement of the suture
through the tissue in the direction of movement of the pointed end
and prevent movement of the suture in a direction opposite the
direction of movement of the pointed end. The anchor prevents
movement of the suture in the direction of movement of the pointed
end. The insertion device includes a tubular element in which the
suture body is at least in part initially disposed and having
leading and trailing ends with openings therein with the pointed
end of the suture proximate to the leading end. The method includes
inserting the pointed end of the suture and the leading end of the
insertion device into the tissue at an insertion point. The pointed
end of the suture and the leading end of the insertion device are
pushed through the tissue until reaching an endpoint. The insertion
device is gripped and pulled at the trailing end to remove the
insertion device. Tissue is manually grouped and advanced along the
suture as desired.
[0011] Also according to the present invention another method of
placing a single-directional suture in tissue using an insertion
device is provided. The suture includes an elongated body, one
pointed end, one end terminating in an anchor, and a plurality of
barbs extending from the periphery of the body. The anchor, when
extended, extends outside the periphery of the body to a greater
degree than the barbs. The barbs permit movement of the suture
through the tissue in the direction of movement of the pointed end
and prevent movement of the suture in a direction opposite the
direction of movement of the pointed end. The anchor prevents
movement of the suture in the direction of movement of the pointed
end. The insertion device includes a tubular element having leading
and trailing ends. The method includes inserting the leading end of
the insertion device at an insertion point and through the tissue
until reaching an endpoint and inserting a leading end of the
suture into the insertion device at least until the trailing end of
the suture is within the insertion device. A plunger is inserted
into the trailing end of the insertion device to abut the trailing
end of the suture. The plunger is depressed to push the leading end
of the suture out of the insertion device. The insertion device is
gripped and pulled at the trailing end to remove the insertion
device, leaving the suture in place. The tissue is manually grouped
and advanced along the body of the suture as desired.
[0012] Also in accordance with the present invention, a method of
performing a surgical procedure using a bi-directional barbed
suture is provided. The barbed suture includes an elongated body,
first and second sharp pointed distal ends for penetrating tissue,
and a plurality of barbs extending from the periphery of the body.
The barbs on a first portion of the body between the first end of
the suture and a first axial location on the body permit movement
of the suture through the tissue in a direction of movement of the
first end and prevent movement of the suture relative to the tissue
in a direction opposite the direction of movement of the first end.
The barbs on a second portion of the body between the second end of
the suture and a second axial location on the body which is less
than the distance from the second end to the first axial location
permit movement of the suture through the tissue in a direction of
movement of the second end and prevent movement of the suture
relative to the tissue in a direction opposite the direction of
movement of the second end. An insertion device is used and
includes a tubular element and leading and trailing ends. The
method includes inserting the leading end of the insertion device
at an insertion point in the tissue, and then advancing the leading
end of the insertion device through tissue until reaching a
selected point. The first pointed end of the suture is inserted
into the insertion device at least until one barb extends out of
the insertion device. The insertion device is gripped and pulled at
the trailing end to remove the insertion device, leaving the full
length of the suture in place in the tissue. Tissue is manually
grouped and advanced along the body of the suture as desired.
[0013] Also in accordance with the present invention is another
method of performing a surgical procedure using a bi-directional
barbed suture. The barbed suture includes an elongated body, first
and second sharp pointed distal ends for penetrating tissue, and a
plurality of barbs extending from the periphery of the body. The
barbs on a first portion of the body between the first end of the
suture and a first axial location on the body permit movement of
the suture through the tissue in a direction of movement of the
first end and prevent movement of the suture relative to the tissue
in a direction opposite the direction of movement of the first end.
The barbs on a second portion of the body between the second end of
the suture and a second axial location on the body which is less
than the distance from the second end to the first axial location
permit movement of the suture through the tissue in a direction of
movement of the second end and prevent movement of the suture
relative to the tissue in a direction opposite the direction of
movement of the second end. The method includes inserting the first
end of the suture into tissue at an insertion point and then
advancing the suture in a generally curvilinear path until the
second axial location is at the point of insertion of the first end
of the suture and the first end of the suture exits the tissue at
an exit point, leaving a length of the first portion of the suture
in the tissue. The second end of the suture is inserted into tissue
at the insertion point of the first end of the suture. The suture
is advanced in a generally curvilinear path distally from the first
portion of the suture, until the second end of the suture exits the
tissue at an exit point, leaving a length of the second portion of
the suture in the tissue. The tissue is manually grouped along the
body of the suture as desired. The amplitude of each curvilinear
path is generally perpendicular to the resultant holding force
exerted by the suture on the tissue.
[0014] Also according to the present invention, a method of placing
a first single-directional barbed suture and a second
single-directional barbed suture in bodily tissue is provided. The
sutures each include an elongated body, one pointed end, and one
trailing end, and a plurality of barbs extending from the periphery
of the body. The barbs permit movement of the suture through the
tissue in the direction of movement of the pointed end and prevent
movement of the suture in a direction opposite the direction of
movement of the pointed end. The method includes inserting the
first end of the first suture into tissue at an insertion point and
then advancing the suture in a generally curvilinear path until the
pointed end of the first suture exits the tissue at an exit point,
leaving a length of the body of the first suture in the tissue. The
pointed end of the second suture is inserted into tissue at the
insertion point of the first suture, and the second suture is
advanced in a generally curvilinear path until the pointed end of
the second suture exits the tissue at an exit point, leaving a
length of the body of the second suture in the tissue. The first
and second sutures are tied together at the insertion point. Tissue
is manually grouped and advanced along the body of each suture as
desired. The amplitude of each curvilinear path is generally
perpendicular to the resultant holding force exerted by each suture
on the tissue.
[0015] Further according to the present invention, another method
of placing a single-directional barbed suture in bodily tissue is
provided. The suture includes an elongated body, one pointed end,
one end terminating in an anchor, and a plurality of barbs
extending from the periphery of the body. The anchor extends
outside the periphery of the body to a greater degree than the
barbs. The barbs permit movement of the suture through the tissue
in the direction of movement of the pointed end and prevent
movement of the suture in a direction opposite the direction of
movement of the pointed end, while the anchor prevents movement of
the suture in the direction of movement of the pointed end. The
method includes making an incision in the tissue to define a face
of the tissue, and inserting the pointed end of the suture in the
face of the tissue. The pointed end of the suture is advanced
through the tissue to an exit point. The anchor is placed in the
incision. The pointed end of the suture is advanced through the
tissue until the anchor achieves adequate holding strength in the
tissue to resist further movement in the tissue, leaving the anchor
embedded in the tissue.
[0016] Yet further according to the present invention, a method for
joining two ends of severed internal tissue to allow tissue healing
and regrowth together of the two ends of the internal tissue in
vivo using a single-directional barbed suture is provided. The
suture includes an elongated body, one pointed end, one end
terminating in an anchor, and a plurality of barbs extending from
the periphery of the body. The anchor extends outside the periphery
of the body to a greater degree than the barbs. The barbs permit
movement of the suture through the tissue in the direction of
movement of the pointed end and prevent movement of the suture in a
direction opposite the direction of movement of the pointed end,
while the anchor prevents movement of the suture in the direction
of movement of the pointed end. The method includes inserting the
pointed end of the suture into a first end of the internal tissue
and pushing the pointed end through the internal tissue along a
curvilinear path, proceeding away from the first end and farther
into the tissue. The pointed end of the suture is gripped and
pulled out of the internal tissue to draw the anchor proximate to
the first end of the tissue. The pointed end of the suture is
pushed along the periphery of the internal tissue adjacent the exit
point. The pointed end is pushed along the curvilinear path and
then returns along the path to the first end, and exiting from the
first end of the tissue. The pointed end is inserted into an
opposing, second end of tissue, and is pushed along a curvilinear
path, proceeding away from the second end and farther into the
tissue, then returning to the second end, and exiting from the
second end of the tissue. The pointed end is inserted into the
first end of tissue, pushing the pointed end along a curvilinear
path, proceeding away from the second end and farther into the
tissue, then returning toward the first end and exiting the
tissue.
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] For a more complete understanding of the present invention,
reference should now be had to the embodiments shown in the
accompanying drawings and described below. In the drawings:
[0018] FIG. 1 is a perspective view of an embodiment of a barbed
suture with an anchor for use according to the methods of the
present invention.
[0019] FIGS. 2-11 are end views of embodiments of barbed sutures
with anchors according to the present invention.
[0020] FIGS. 12-20 are elevation views of embodiments of barbed
sutures with anchors according to the present invention.
[0021] FIG. 21 is an elevation view of a conventional means for
affixing a suture to an attachment.
[0022] FIGS. 22 and 23 are elevation views of means for affixing
sutures to anchors in accordance with the present invention.
[0023] FIGS. 24 and 25 are elevation views of a suture having a
looped end according to the present invention.
[0024] FIGS. 26 and 27 are plan views of embodiments of methods
according to the present invention for joining two sides of an open
wound in tissue.
[0025] FIGS. 28 and 29 are plan views of embodiments of methods
according to the present invention for joining two sides of an open
wound in tissue.
[0026] FIGS. 30 and 31 are plan views of embodiments of methods
according to the present invention for inverting a surface wound in
tissue.
[0027] FIGS. 32-39B are plan views of additional embodiments of
methods according to the present invention for joining two sides of
an open wound in tissue.
[0028] FIGS. 40 and 41 are plan views of conventional methods for
positioning tissue.
[0029] FIGS. 42-45 are plan views of embodiments of methods
according to the present invention for positioning tissue relative
to a barbed suture disposed in the tissue.
[0030] FIGS. 46-48 are section views of embodiments of methods
according to the present invention.
[0031] FIGS. 49 and 50 are plan views of further embodiments of
methods according to the present invention for positioning tissue
along a barbed suture disposed in the tissue.
[0032] FIGS. 51A-51C are plan views of an embodiment according to
the present invention for joining two ends of a severed tendon.
[0033] FIGS. 52-55 are plan views of embodiments according to the
present invention for joining two bodily tube ends.
[0034] FIG. 56 is a detail view of an embodiment according to the
present invention of a barb configuration.
[0035] FIG. 57 is a plan view of an example performed according to
the present invention for joining two sides of an open wound in
tissue.
[0036] FIG. 58 is a plan view of an example performed according to
a conventional method for joining two sides of an open wound in
tissue.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0037] As used herein, the term "wound" means a surgical incision,
cut, laceration, severed tissue or accidental wound in human skin
or other bodily tissue, or other condition where suturing,
stapling, or the use of another tissue connecting device might be
required.
[0038] As used herein, the term "tissue" includes tissues such as
skin, bone, muscle, organs, and other soft tissue such as tendons,
ligaments and muscle.
[0039] Certain other terminology is used herein for convenience
only and is not to be taken as a limitation on the invention. For
example, words such as "upper," "lower," "left," "right,"
"horizontal," "vertical," "inward," "outward," "upward," and
"downward" merely describe the configuration shown in the figures.
It is understood that the components may be oriented in any
direction and the terminology, therefore, should be understood as
encompassing such variations unless specified otherwise.
[0040] Barbed sutures and placement methods suitable for use
according to the methods of the present invention are described in
U.S. Pat. No. 5,342,376, entitled "Inserting Device for a Barbed
Tissue Connector", U.S. Pat. No. 5,931,855, entitled "Surgical
Methods Using One-Way Suture", U.S. Pat. No. 6,241,747, entitled
"Barbed Bodily Tissue Connector", U.S. Pat. No. 6,599,310, entitled
"Suture Method", U.S. patent application Ser. No. 10/065,256,
entitled "Suture Method", U.S. patent application Ser. No.
10/065,278, entitled "Barbed Suture in Combination with Surgical
Needle", U.S. patent application Ser. No. 10/065,279, entitled
"Barb Configurations for Barbed Sutures", and U.S. patent
application Ser. No. 10/065,280, entitled "Barbed Sutures". The
contents of U.S. Pat. No. 5,342,376, U.S. Pat. No. 5,931,855, U.S.
Pat. No. 6,241,747, U.S. Pat. No. 6,599,310, U.S. patent
application Ser. No. 10/065,256, U.S. patent application Ser. No.
10/065,278, U.S. patent application Ser. No. 10/065,279, and U.S.
patent application Ser. No. 10/065,280 are hereby incorporated by
reference.
[0041] Referring now to the drawings, wherein like numerals
designate corresponding or similar elements throughout the several
views, FIG. 1 is a perspective view of a single-directional barbed
suture 90 having a suture body 92 with barbs 94 extending from
around the periphery thereof, a pointed end 96, and an anchor 98 at
the other end. The anchor 98 comprises a bar which extends radially
outwardly of the suture body 92 in a plane substantially
perpendicular to the longitudinal axis of the suture body 92, which
generally gives the barbed suture 90 a "T" shape. Many other shapes
and configurations of anchors are feasible, as shown in the
embodiments in end view (with the suture body normal to and into
the page) in FIGS. 2-11. Each of the anchors shown in FIGS. 2-11
have limbs which extend radially outwardly from the suture body 92
a greater distance than the barbs 94. The anchors 98 on the barbed
sutures 100, 102, 104, 106 depicted in FIGS. 2-5, respectively,
have one or a plurality of limbs 108 generally evenly spaced around
the periphery at the end of the suture. The embodiments of the
barbed sutures 110, 112, 114 shown in FIGS. 6-8 have anchors 98
including a plurality of limbs 108 which extend from only a portion
of the periphery at the end of the suture body 92. FIGS. 9-11 show
embodiments of the barbed sutures 116, 118, 120 wherein each of the
respective limbs 122-123, 124-126, 127-130 are of different
lengths.
[0042] FIGS. 12-20 are further embodiments of barbed sutures at one
end. FIG. 12 shows a barbed suture 132 that has an anchor 134
having limbs 136 that are concave toward the other end of the
suture. FIG. 13 shows a barbed suture 138 with an anchor 140 having
limbs 142 that are concave away from the pointed end of the suture.
FIG. 14 shows a barbed suture 144 with an anchor 146 as shown in
FIG. 1, further including a plurality of segments 148 extending
from the bar toward the other end of the suture. FIG. 15 shows a
barbed suture 150 having a hemispherical anchor 152. FIG. 16 shows
a barbed suture 154 having an anchor 156 that resembles a
coneflower. FIG. 17 shows a barbed suture 158 having an anchor 160
formed by a loop of the body 92 that crosses itself to form a clip,
wherein tissue may be received between the clip. FIG. 18 shows a
barbed suture 162 having an anchor 164 formed by a hook of the
suture body 92. FIG. 19 shows a barbed suture 166 having an anchor
resembling an "M" wherein the body 92 of the suture extends from
the middle leg of the "M". FIG. 20 shows a barbed suture 170 having
a single barb 172, larger than the opposing barbs 94, extending
towards the other end of the suture 170. As demonstrated by the
variety of anchor designs of FIGS. 12-20, many anchor designs are
possible for use with the barbed suture and within the scope of the
present invention.
[0043] The anchors shown in FIGS. 1-20 may be integrally formed
with the body 92 of the barbed suture or, alternatively, may be
mounted to the end of the suture. FIGS. 21-23 demonstrate ways that
the anchors may be affixed to the barbed sutures. FIG. 21 shows the
anchor 172 of FIG. 20. The end of the anchor 172 has an axial bore
178. Teeth 176 are provided on the inside of the bore 178 and
angled inwardly. The suture body 92 is inserted into the bore 178
and the end of the anchor 172 is crimped around the suture body 92.
FIG. 22 shows the anchor 172 including a plurality of spaced rings
182 on the end of the suture body 92. The end of the suture body 92
is inserted through the rings 182. Barbs 184 are provided on the
suture body 92 that oppose the rings 182 and secure the suture body
92 in place by engaging the rings 182. FIG. 23 shows a connection
186 between the anchor 188 and barbed suture body 92 made with, for
example, glue or heat.
[0044] FIG. 24 shows a suture 190 having a loop 192 at one end.
Referring to FIG. 25, the suture 190 is placed in tissue 194 by
passing the suture 190 through tissue 194 and then through the loop
192. Tissue 194 is trapped by the suture 190 and the loop 192
resulting in the suture 190 being anchored.
[0045] The anchors according to the present invention may be formed
by stamping and drilling, injection molding, or a laser cutting
system, or other method as selected by one of ordinary skill in the
art. The anchors may be made of bio-absorbable material, or a
material as selected by one of ordinary skill in the art.
[0046] Various bio-absorbable polymers include, but are not limited
to, polydioxanone, polylactide, polyglycolide, polycaprolactone,
and copolymers thereof. Commercially available examples are
polydioxanone (sold as PDS II, a trade name used by Ethicon for
selling surgical sutures), copolymer of about 67% glycolide and
about 33% trimethylene carbonate (sold as MAXON.RTM., a trademark
registered to American Cyanamid for surgical sutures), and
copolymer of about 75% glycolide and about 25% caprolactone (sold
as MONOCRYL.RTM., a trademark registered to Johnson & Johnson
for sutures and suture needles). Barbed sutures made from such
bio-absorbable materials are useful in a wide range of
applications.
[0047] Additionally, anchors may be formed from a non-absorbable
material, which may be a polymer. Such polymers include, but are
not limited to, polypropylene, polyamide (also known as nylon),
polyester (such as polyethylene terephthlate),
polytetrafluoroethylene (such as expanded polytetrafluoroethylene,
sold by Gore as GOR-TEX.RTM.), polyether-ester (such as
polybutester, which is the condensation polymerization of dimethyl
terephthlate, polytetramethylene ether glycol, polymers having
ester units (such as polyglycolide), and 1,4-butanediol, and which
is marketed by Davis & Geck and by U.S. Surgical, companies
owned by Tyco, under the name NOVAFIL.RTM., which is a trademark
registered to American Cyanamid for surgical sutures), or
polyurethane Alternatively, the non-absorbable material may be
metal (e.g., steel), metal alloys, natural fiber (e.g., silk,
cotton, et cetera), and the like.
[0048] As used herein, the term wound means a surgical incision,
cut, laceration, severed tissue, or accidental wound in human skin
or other bodily tissue, or other condition where suturing, stapling
or the use of another tissue connecting device might be
required.
[0049] FIGS. 26-39B show a variety of methods of suture placement
in tissue for approximating the sides of wounds or separated tissue
according to several embodiments of the present invention. The
methods of suture placement include one or more terminal
J-stitches, S-stitches, or the like. A terminal J-stitch, S-stitch,
or the like comprises a suture placement method wherein a portion
of the end of the suture extends in a different direction relative
to the adjacent portion of the suture. The relative direction of
the end portion of the suture may be, for example, at least
approximately 30 degrees from the projected path of the adjacent
portion of the suture. For convenience herein, reference is made to
J-stitches and S-stitches, but it is understood that suture
placement may differ from J-stitches or S-stitches yet still be
within the scope of the present invention. Placement of the suture
according to the methods of the present invention may be done
either by needles or insertion devices as discussed below.
Placement in such patterns may be facilitated by manipulation of
tissue in addition to or in place of manipulation of the sharp
pointed end of the suture. Tissue may be manually grouped and
advanced along the suture in accordance with the present invention
as described and shown herein.
[0050] Reference is sometimes made herein to pointed ends of a
suture. The pointed ends of the suture may be straight or curved.
In one embodiment, the pointed ends of the suture may be surgical
needles secured at each end of the body of the suture so that the
body extends between the shank ends of the two needles. The needles
are preferably constructed of stainless steel or other surgical
grade metal alloy. The needles may be secured to the suture body by
means of adhesives, crimping, swaging, or the like, or the joint
may be formed by heat shrinkable tubing. A detachable connection
may also be employed such that the needles may be removed from the
body of the suture by a sharp tug or pull or by cutting. The length
of the needles is selected to serve the type of tissue being
repaired so that the needles can be completely removed leaving the
suture body in the desired position within the tissue.
[0051] In FIG. 26, the sides of a wound 250 in tissue 252 are
approximated using two bi-directional barbed sutures 254, 256
having barbs 94. Throughout the figures, solid line sutures
indicate the sutures are visible, dashed line sutures indicate the
sutures are embedded in tissue, and dotted line sutures indicate an
alternative embedded location for the suture. A first suture 254 is
positioned using a suture method wherein the two ends are placed in
the tissue using a terminal J-stitch 260, 262. A second suture 256
is positioned in the tissue using a suture method wherein the two
ends are placed in the tissue using a terminal S-stitch 264, 266.
The J-stitches 260, 262 and S-stitches 264, 266 are shown to be
pointing in the direction of the other suture, or "inward," but
could also be pointed outward in the alternative locations 260a,
262a, 264a, 266a depending on the application and preference of one
of ordinary skill in the art. As an example showing the placement
of a J-stitch, the end portion of the J-stitch 262 of the first
suture 254, aligned along A, is positioned at angle .theta. from
the projected path of the adjacent portion of the suture 254 B, and
is shown to be about 90 degrees. As an example showing the
placement of an S-stitch, the end portion of the S-stitch 266 of
the second suture 256, aligned along C, is positioned at angle a
from the projected path D of the adjacent portion of the suture
256, and is shown to be about 45 degrees. The J-stitch and S-stitch
angles H and a may be greater or less than shown and the suture is
still considered to be in accordance with the present
invention.
[0052] FIG. 27 shows single-directional barbed sutures 270, 272
approximating the sides of a wound 250. Each suture 270, 272 has an
anchor 274, 276 and is placed in the tissue 252 using a method
which ends with a terminal J-stitch 278 or S-stitch 280 at the
opposite end. Alternative J-stitch or S-stitch positions 278a, 280a
may be used. Anchors may be embedded in the tissue 252 as with the
anchor 274 of a first suture 270 by making a small incision, or may
be above the tissue as with the anchor 276 of a second suture 272.
The sutures 270, 272 may be placed with a sharp pointed end such as
a needle at the opposite, leading end of the suture from the
anchors 274, 276. The anchors 274, 276 are shown schematically; it
is understood that a variety of anchors is available as
appropriate, as previously discussed.
[0053] For convenience in the remaining embodiments described
herein, mostly J-stitches are shown. It should be understood,
however, that in all embodiments shown herein that have a suture
placed with a needle, S-stitches could replace any depicted
J-stitches. In one method of grouping and advancing tissue along
the suture body, the sharp pointed end of the suture exits the
tissue prior to completing, for example, the J-stitch. Then the
tissue is grouped and advanced along the suture body, and then the
suture pointed end enters the tissue to complete the J-stitch.
[0054] FIGS. 28 and 29 show suture methods using an alpha stitch
pattern using a bi-directional barbed suture 254 and a single
direction suture 270, respectively, to close a wound 250. The
suture method using the bi-directional barbed suture 254 of FIG. 29
has a J-stitch at each end that may be either downward 284, 286,
upward 284a, 286a, or a combination thereof. The suture method
using the single direction suture of FIG. 29 has a J-stitch shown
at its leading end that may be either downward 288 or upward 288a.
A purse-string stitch is a surgical suture method used to repair
excisions, such as in as appendectomy, where inverting the
remaining tissue is desired. A purse-string stitch may be used
according to the methods of the present invention with a
bi-directional barbed suture 254 or a single direction suture 270
as shown in FIGS. 30 and 31, respectively. The description of FIG.
28 applies to FIG. 30, and the description of FIG. 29 applies to
FIG. 31.
[0055] FIGS. 32 and 33 show suture methods using a zigzag pattern
to approximate the sides of a wound 250 with a bi-directional
barbed suture 254 and a single-directional barbed suture 270 with
an anchor 274, respectively. As previously shown in FIG. 26 and as
shown in FIG. 32, the terminal end path A of the end portion of the
suture 254 in the J-stitch 262 is at an angle from the projected
suture path B of the adjacent portion of the suture. The J-stitch
angle shown is about 135 degrees. It is understood that the angle
may vary and still be considered a J-stitch.
[0056] FIGS. 34 and 35 show a suture method for approximating the
sides of a wound using a bi-directional barbed suture 254 and a
single direction barbed suture 270 with an anchor 274,
respectively, placed in the tissue 252 in a sinusoidal pattern.
[0057] FIGS. 36 and 37 show a bi-directional barbed suture 254 and
a single direction barbed suture 270 with an anchor 274,
respectively, placed in the tissue 252 in a corkscrew pattern.
[0058] With respect to the bi-directional suture 254 of FIGS. 32,
34, and 36, the suturing begins at an intermediate point between
the ends of the wound and proceeds in both directions. In the
zigzag and sinusoidal patterns of FIGS. 32 and 34, respectively,
the central portion of the suture 254, where the barbs 94 change
direction, could also be located at one end of the wound, with both
ends of the suture proceeding in the same direction along the wound
in separate patterns which are mirror images of one another. Both
ends of the suture could then have a J-stitch or S-stitch at the
same end of the wound. The J-stitches of FIGS. 32, 34, and 36 may
be inward 260, 262, outward 260a, 262a, or a combination thereof.
The J-stitches of FIGS. 33, 35, and 37 may be inward 278 or outward
278a. Further, the suture 270 shown in FIGS. 33 and 35 could double
back in a mirror image pattern to the end of the wound placing the
leading end near the anchor 274, and could have a J-stitch or
S-stitch at that location.
[0059] The anchors 274 of FIGS. 33, 35, and 37 are shown as
contacting the surface of the tissue 252. Another method according
to the present invention allows placement of the anchor 274 below
the surface of the tissue as shown in FIGS. 38A and 38B.
[0060] As shown in FIG. 38A, a sharp pointed end of the suture 270,
for example, a needle 280, is at the leading end of a
single-directional barbed suture 270 and is inserted into a face
288 of a wound 250. As the suture 270 is pulled through the tissue
by the needle 280, the anchor 274 will abut the face of the wound
288. As the suture is pulled to approximate the wound, the anchor
274 will move until it meets resistance in the tissue 252. The
tissue 252 generally comprises layers that are parallel to the
surface of the tissue. Depending on the shape of the anchor 274,
the anchor 274 may be expected to move between the layers and past
the face 288 of the wound 250, embedding into the adjacent tissue,
arriving in a position spaced from the face 288 of the wound 250 as
shown in FIG. 38B. Referring to FIG. 38A, in one embodiment, as
selected by one of ordinary skill in the art the distance E from
the end of the wound to the anchor 74 may be approximately the same
as the distance between "bites," or the distance F from the face
288 of the wound to the peak 291 of the pattern.
[0061] Another suture method using a single directional barbed
suture wherein anchors are embedded in tissue is used for
approximating a small wound, as shown in FIGS. 39A and 39B. In FIG.
39A, the needle 280 at the leading end of a single-directional
barbed suture 270 is inserted into the face 288 of a wound 250.
Similarly to the method shown in FIGS. 38A and 38B, as the suture
270 is pulled by the needle 280, the anchor 274 will abut the face
288 of the wound 250. As the suture is pulled to approximate the
sides of the wound 250, the anchor will move into the tissue 252
until it meets resistance in the tissue 252. In FIG. 39B, the
anchor is shown to have moved into final position spaced from the
wound face 288. The placement of the suture 270 may form a loop,
and the leading end may be placed as a J-stitch with alternative
configurations 278, 278a.
[0062] FIGS. 40-50 show suture method according to the present
invention wherein barbed sutures are placed to position tissue
where there is no wound and the sutures are below the surface of
the tissue, such as in cosmetic surgery. FIGS. 40 and 41 show the
placement conventional, non-barbed sutures in tissue for providing
lift. The method of FIG. 40 uses one suture 300 with one knot 302
at the top and an exit/entry point 304 at the bottom. The knot is
tightened to adjust the tissue 252 to the desired amount of lift.
The method of FIG. 41 uses two sutures 306, 308 with one knot 310
at the top and another knot 312 at the bottom. The knots are
tightened to provide the desired amount of lift to the tissue 252.
The force sufficient to provide tissue lift is applied at the knots
302, 310, 312, and the load on the tissue 252 is concentrated at
the top knots 302, 310 and bottom knot 312 or low point 304 of the
sutures.
[0063] FIG. 42 shows a suture method according to the present
invention wherein bi-directional barbed sutures 254, 256 are placed
substantially parallel to one another and having J-stitches 260,
262, 264, 266 at each end that are directed toward the adjacent
suture, or inward. FIG. 43 shows a similar suture method using two
parallel bi-directional barbed sutures 254, 256 with the J-stitches
260a, 262a, 264a, 266a directed outwardly. FIG. 44 shows a
bi-directional barbed suture 254 with terminal J-stitches 314, 316
extending in opposite directions. Once the sutures 254, 256 are
placed, the tissue may be manually advanced along each suture to be
grouped as desired by the surgeon for a certain amount of tissue
lift. Unlike the conventional methods of FIGS. 40 and 41, the
resistance provided by the barbed sutures is distributed along the
length of the suture.
[0064] FIG. 45 shows an embedded single-directional barbed suture
270 having an anchor 274 and a pointed end 320 positioned below the
surface of the tissue 252 and terminating in a J-stitch 278.
Optionally the J-stitch 278 may be oriented differently or omitted
altogether.
[0065] One method of placing a single-directional barbed suture 270
below the surface of tissue 252 is with an insertion device.
Insertion device designs include straight, curved, and corkscrew.
One such method of using an insertion device 322 is shown in FIG.
46. The insertion device 322 may include a straight or curved tube
324, a leading end 326, a trailing end 328, and a handle 330 for
ease of use. Some nonlinear suture installations may be performed
with a straight tube by manipulation of tissue rather than with a
curved tube. The pointed end 320 of the suture 270 may extend from
the leading end 326 of the insertion device 322 or from an opening
(not shown) in the side of the insertion device 322. At least one
barb 94 on the suture 270 must extend through the opening at the
leading end 326 or through the opening at the side of the insertion
device. Alternatively, an anchor 274 could extend through the
opening at the leading end 326 or through the opening at the side
of the insertion device. The insertion device 322 is advanced
through the epidermis 332 and into subcutaneous tissue 334. When in
the desired position, the insertion device 322 is withdrawn by the
trailing end 328, and the pointed end 320 and barbs 94 of the
suture 270 engage in the subcutaneous tissue 334, leaving the
suture 270 in place to restrict movement in one direction as shown
in FIG. 48. The anchor 274 is also embedded, restricting movement
in the other direction.
[0066] Another method of placing a single-directional barbed suture
270 with an insertion device is shown in FIG. 48. The insertion
device 340 has a straight or curved tube 342, a leading end 344, a
trailing end 346, and a reciprocating plunger 348. The anchor 274
is disposed in the tube 342 adjacent the leading end 344 of the
insertion device 340. The insertion device 340 is advanced through
the epidermis 330 and into the subcutaneous tissue 334. When in the
desired position, the plunger 348 is depressed until the anchor 274
is expelled from the tube 342 and into the subcutaneous tissue 334.
As the insertion device 340 is withdrawn from the trailing end 346,
the anchor 274 engages in the tissue to restrict movement in one
direction. The barbs 94 also engage of the subcutaneous tissue 334,
restricting movement in the opposite direction.
[0067] The anchor 274 may be any design that fits within the
insertion device, and may include collapsing designs that are
collapsed while within the insertion device tube and expand when
released. A "T" shape design is shown in the figures for
convenience, and may be used when configured to fold along the
direction of the insertion device tube. Further, the methods
illustrated in FIGS. 45-48 and described above may also be used to
place single-directional barbed sutures with an insertion device to
approximate the sides of a wound, as shown in FIG. 27.
[0068] FIG. 49 shows placement of five bi-directional barbed
sutures 380, 400-403 using methods for cosmetic lifts for the brow,
face, and neck according to the present invention. Each of the five
bi-directional barbed sutures 380, 400-403 shown may be placed, in
one embodiment, using a straight needle at each end. For a brow
lift, the ends of the suture 380 forming an inverted "U" or "V"
shape, or variations thereof, enter at the same insertion point
382, generally superior to the hairline (or where the hairline
would be expected). Sutures 400-403 may be placed with the ends
extending in generally opposite directions starting from an
insertion point 404-407 that may generally be superior to the
expected hairline and exiting distally. In all methods, a
side-to-side motion with the needle is used, in one embodiment
without exiting the tissue until terminating, for placing the
suture in a sinusoidal pattern. The sinusoidal pattern may have
greater or lesser amplitudes and frequencies than those shown in
FIG. 49 and be within the scope of the present invention. As an
alternative to bi-directional barbed sutures 380, 400-403,
single-directional barbed sutures could be used for each portion
384, 386, 408, 410-416 of the respective sutures and their ends
tied at the insertion points 382, 404-407 to the adjacent suture.
Further, there may be generally straight portions of placed suture
between the curvilinear portions and exit points. Following
placement of a suture, tissue is advanced and grouped along the
body of the suture for providing lift and tissue support.
[0069] Placement of a suture in a sinusoidal pattern increases the
suture's "shock-absorbing" capability and provides multiple
opportunities for the suture to elongate or straighten and prevent
shifted or repositioned tissue from relapsing (moving toward its
original position). The amplitude of the curvilinear pattern is
generally perpendicular to the direction of the resultant holding
force of the suture, which is generally along the axis of the
curvilinear pattern. An example amplitude is shown at G in FIG. 49
and an example resultant holding force is shown at H. Pulling of
the tissue may cause the tissue to relapse more than with
straight-placed sutures, but there may be less breakage of the
sinusoidally placed sutures because of the flexure provided by the
sinusoidal pattern. The sinusoidal pattern may permit larger or
tighter lifts as compared to the same number and size of sutures
that are linearly placed. The sinusoidal pattern may also allow the
use of fewer and bigger sutures, which may be desirable when the
patient does not want to be sedated.
[0070] For the browlift sutures 380, 400 and other lifts on the
forehead, the portion 384, 386, 408 of the suture in the forehead
engages just above muscle, frontalis, in subepidermal tissue.
Subepidermal tissue includes the papillary dermis, reticular
dermis, and subcutaneous tissue. The portions 410-413 of the
sutures 400-403 extending into the scalp engage the galea
aponeurotica and subepidermal tissue.
[0071] In general, for the sutures 401-403 in the face and neck,
the anterior portions 414-416 engage just above muscle, platysma,
but are slightly more superficial in the cheek or near the nose,
and in subepidermal tissue. In particular, the anterior portion 414
of the facelift suture 401 in the upper face extends toward the
nasolobial fold 418, engaging the subepidermal tissue, superficial
muscular aponeurotic system, or both.
[0072] Specifically with respect to the facelift suture 402 in the
cheek, the insertion point 406 is approximately at the posterior
mandibular angle. The first end 412 of the suture is pushed
posterially through subepidermal tissue, the superficial
aponeurotic system, or combinations thereof along a path
approximately parallel to the mandibular border, exiting distally.
The second end 415 of the suture is pushed anteriorly through
subepidermal tissue, the superficial aponeurotic system, or
combinations thereof along a path approximately parallel to the
mandibular border, also exiting distally.
[0073] For the surgical procedure comprising a neck lift, the
insertion point 407 of the barbed suture 403 is approximately at
the upper sternomastoid muscle. The first end 413 of the suture is
pushed posterially through subepidermal tissue, the superficial
aponeurotic system, or combinations thereof along a path
approximately parallel to the mandibular border, exiting distally.
The second end 416 of the suture is pushed anteriorly through
subepidermal tissue, the superficial aponeurotic system, or
combinations thereof along a path approximately parallel to the
mandibular border, also exiting distally.
[0074] Additional cosmetic surgery applications may be performed
within the scope of the present invention. For example, thigh lifts
and breast lifts may be performed. In a thigh lift the insertion
point is generally at the inguinal crease. The first end of the
suture is pushed cranially through subepidermal tissue until the
first end of the suture extends out of the tissue, and the second
end of the suture is pushed caudally through subepidermal tissue
until the second end of the suture extends out of the tissue on the
thigh. The thigh tissue is then advanced and grouped along the body
of the suture for providing lift and tissue support.
[0075] In a breast lift, the insertion point is at the upper aspect
of the breast curvature. The first end of the suture is pushed
through subcutaneous tissue, dermal tissue, and pectoralis muscle
until extending out of the tissue at an exit point on the upper
portion of the breast. The second end of the suture is pushed
caudally through fibrous and fatty tissues until the second end of
the suture extends out of the tissue at an exit point along the
anterior aspect or the lower curvature of the breast. The breast
tissue is then advanced and grouped along the body of the suture
for providing lift and tissue support.
[0076] FIG. 50 shows suture methods for cosmetic surgery
applications using single-directional barbed sutures 430-435 with
anchors 436-441 according to the present invention. These suture
methods may optionally include a terminal J-stitch or S-stitch (not
shown), and may be placed with an insertion device 322, 340 as
shown in FIGS. 46-49 or with a needle. For example, one suture 434
along the jaw line is shown as terminating at its pointed end with
an S-stitch. Another suture 433 in the upper face is shown having a
curvilinear pattern similar to those of FIG. 49. Although a
schematic "T" shape anchor 436-441 is shown, the anchor may be any
design as described herein and selected by the surgeon depending on
the application. The anchors may be embedded either by use of an
insertion device or by making a small incision. Another suture 442
is shown in the forehead and is placed with curves at the ends 444,
445, including a J-stitch proximate to the end 445 at the brow.
Applications to brow, face, neck, thigh, and breast are similar to
and correspond to those detailed above for bi-directional sutures
in similar locations with respect to the tissue engaged. Following
placement of the suture, tissue is advanced and grouped along the
body of the suture for providing lift and tissue support. As a
variation to grouping and advancing the tissue along the suture
after completing the desired pattern, such as a J-stitch, the
suture pointed end may exit the tissue prior to completing the
J-stitch, then the tissue may be grouped and advanced, and then the
J-stitch may be completed.
[0077] FIGS. 51A-51C show the use of a single-directional barbed
suture 270 for repair of two parts of a severed tendon 450, 452,
referred to for convenience as the left part 450 and right part
452. As shown in FIG. 51A, the suture enters the end 454 of the
left part 450 and follows a curvilinear path to an exit point 456.
The anchor 274 abuts the end 454 of the left part 450. The suture
enters again at a point 458 adjacent to the exit point 456 and
continues to form a loop on the curvilinear path until exiting at
point 460 and then entering at point 462. The suture completes the
loop and exits through the end 454 of the left part 450 then passes
through the end 464 of the right part 452. As shown in FIG. 51B,
the suture follows the selected curvilinear path advancing through
the tendon 252 away from the end 464 by exiting at points 466, 468,
470 and entering at points 472, 474, 476, and then returns back to
the end 464 by exiting the tendon through points 478, 480, 482 and
entering through points 484, 486, 488. As shown in FIG. 51C, the
suture then again enters the end 454 of the left part 450, follows
the selected curvilinear path exiting the tendon at points 490,
492, 494, 496 and entering at points 498, 500, 502, 504 until
making a final exit 506 from the periphery of the tendon.
[0078] Also according to the present invention, methods are
provided for joining the ends of two portions of a tube, a tubular
structure, or a hollow organ within the body using a barbed suture,
such as the ends of a blood vessel in an anastomosis procedure. As
used herein, the term "tube" includes but is not limited to, blood
vessels, the large and small intestine, ducts, and the like. As
shown in FIGS. 52-55, the ends of the tube may be first cut at an
angle prior to joining for promoting a more effective
attachment.
[0079] Referring to FIG. 52, a method is shown for joining the ends
of a tube using a single-directional barbed suture 270 having an
anchor 274. The pointed end 280 of the barbed suture 270, which in
the embodiment shown comprises a needle, is inserted through the
wall and into the interior of a first end 550 of the tube. The
pointed end of the suture 270 is then inserted from the interior of
the tube through the wall of a second end 552 of the tube. The
suture 270 is pulled through the walls of the tube until the anchor
274 contacts the outer surface of the wall of the first end 550 of
the tube for drawing the two ends 550, 552 of the tube together.
The suture 270 is then again inserted through the wall of the first
end 550 of the tube at a point 554 circumferentially spaced from
the initial insertion point 556. The steps are repeated for
advancing the suture 270 around the tube. After the last bite, the
suture pattern may be completed with a terminal J-stitch or
S-stitch.
[0080] FIG. 53 shows a method of using a bi-directional barbed
suture 254 for joining the ends 550, 552 of a tube using a similar
suture pattern as the method shown in FIG. 52. Beginning at an
initial insertion point 558, an end of a first portion 560 of the
suture 254 is inserted through the wall and into the interior of a
first end 552 of the tube. The end of the first portion 560 of the
suture 254 is then inserted from the interior of the tube through
the wall of a second end 550 of the tube. The first portion 560 of
the suture 254 may be pulled through the walls of the tube until
the opposed barbs on a second portion 562 of the suture 254 contact
the outer surface of the wall of the first end 552 of the tube for
drawing the two ends 550, 552 of the tube together. The end of the
first portion 560 of the suture 254 is inserted through the wall
and into the interior of the first end 552 of the tube at a point
564 circumferentially spaced in a first direction from the initial
insertion point 558. The end of the second portion 562 of the
suture 254 is inserted through the wall and into the interior of
the second end 550 of the tube at a point 566 circumferentially
spaced from the exit point 568 of the end of the first portion 560
of the suture 254. The end of the second portion 562 of the suture
254 is then inserted from the interior of the tube through the wall
of the first end 552 of the tube at a point 570 circumferentially
spaced in a second direction from the initial insertion point 558.
These steps are repeated for advancing each end of the barbed
suture 254 around the tube. After the last bite, the suture pattern
may be completed with a terminal J-stitch or S-stitch at each
end.
[0081] FIG. 54 shows another method of using a bi-directional
barbed suture 254 for joining the ends 550, 552 of a bodily tube.
Beginning at an initial insertion point 572, an end of a first
portion 560 of the suture 254 is inserted through the wall of a
first end 552 of the tube. The end of the first portion 560 of the
suture 254 is then inserted from the interior of the tube through
the wall of a second end 550 of the tube. The first portion 560 of
the suture 254 may be pulled through the walls of the tube until
the opposed barbs on a second portion 562 of the suture 254 contact
the outer surface of the wall of the first end 552 of the tube for
drawing the two ends 550, 552 of the tube together. The end of the
first portion 560 of the suture 254 is inserted through the wall
and into the interior of the first end 552 of the tube at a point
574 circumferentially spaced in a first direction from the initial
insertion point 572. The end of the second portion 562 of the
suture 254 is inserted through the wall of the first end 552 of the
tube at a point 576 adjacent the initial insertion point 572 of the
first portion 560 of the suture 254, which practically functions as
the same point of insertion. The end of the second portion 562 of
the suture 254 is then inserted from the interior of the tube
through the wall of the second end 550 of the tube at a point 578
circumferentially spaced from the first exit point 580 of the end
of the first portion 560 of the suture 254. The end of the second
portion 562 of the suture 254 is then inserted through the wall of
the first end 552 of the tube at a point 582 circumferentially
spaced in a second direction from the initial insertion point 576.
These steps are repeated for advancing each end of the barbed
suture 254 around the tube. After the last bite, the suture pattern
may be completed with a terminal J-stitch or S-stitch at each end.
Alternatively, the suture pattern may continue as described until
the ends of the suture cross one another, as shown in FIG. 55. Even
then the suture pattern may be completed with a terminal J-stitch
or S-stitch, if desired.
[0082] In the method for joining the ends of a tube according to
the present invention, the path of insertion of the end of the
suture through the tube may include a longitudinal component as the
suture is advanced through the tissue of the tube. Using this
technique, more of the length of the suture is placed in the tissue
of the tube, which may result in better holding strength.
Additionally, effective joining of the ends of a tube within the
body can be achieved using the methods described herein regardless
of where the barbed suture initially enters the tube along the
periphery of the free end.
[0083] It is understood that although the methods of joining two
ends of a bodily tube is shown and described, the present invention
is not so limited. In particular, the methods according to the
present invention may include a procedure wherein a portion of tube
is grafted between the ends of the original tube. This is a
procedure particularly used in coronary artery bypass grafting, or
CABG. The grafting procedure is similar to the methods described
herein except that the ends of the graft are attached to the ends
of the tube using the suture methods described above.
[0084] The invention is further illustrated by the following
non-limiting example.
EXAMPLE
[0085] Testing was performed comparing the tissue holding capacity
of a bi-directional barbed suture placed in tissue with a J-stitch
at each end with a conventional knotted suture. Two different barb
geometry designs (A and B) of a bi-directional barbed suture were
fabricated from polydioxanone (PDO), size 0. Each suture was 7
inches long and included 78 barbs, equally divided into two
opposing segments, in the middle 3 inches. The spirality of Design
A was 12.8 degrees, and the spirality of Design B was 12.4 degrees.
The average straight-pull tensile strength of each design was
measured using ten samples. Using an Optem Zoom microscope (made by
Thales Optem Inc. of Fairport, N.Y.) with an attached video camera,
the barb geometries were characterized by four different
parameters: cut angle (.phi.); cut depth (D.sub.c); calculated cut
length (L.sub.c); and the distance between cuts (FIG. 56).
[0086] The straight-pull tensile strengths and barbed geometries of
the barb sutures were determined to be as shown in Table 1.
TABLE-US-00001 TABLE 1 Parameters Design A Design B Tensile
strength (lb.) 7.12 .+-. 0.25 9.89 .+-. 0.34 Cut angle, .phi.
(.degree.) 152.3 .+-. 0.8 162.2 .+-. 2.2 Cut depth, D.sub.c (mm)
0.25 .+-. 0.01 0.12 .+-. 0.02 Cut length, L.sub.c (mm) 0.54 .+-.
0.02 0.38 .+-. 0.04 Distance between cuts (mm) 0.82 .+-. 0.01 0.91
.+-. 0.04
[0087] Referring to FIGS. 57 and 58, a full-thickness, 3-cm
incision was created in the distal jejunum 530 of a cadaveric pig
perpendicular to its length. The jejunal segment measured about 10
cm in outer circumference and 5 mm in thickness. Each wound 538 was
excised so that it was centered on a 4 cm by 15 cm piece of tissue.
The wound 538 was closed with either a barbed suture 254 including
the two Designs A and B as shown in FIG. 57, or control PDS II
(polydioxanone) suture 540 as shown in FIG. 58, all of size 0,
using a running "over-and-over" technique. Suture strands, in the
serosa 542 and mucosa 544, engaged but did not perforate the
mucosal layer. A knot (5 throws) anchored each end of the control
suture, whereas the barbed suture 254 was finished with and without
a J-stitch bite through adjacent tissue. Bite size (4 mm), distance
between bites (5 mm), and number of crosses of the incision (11)
were equivalent in all suture types. Wound edges were cut such that
only the sutures held the two halves together. Ten sutured tissue
specimens of each suture type were tested on a Test Resources
Universal Tester, model 200Q (made by DDL of Eden Prairie, Minn.),
with a 250 lb. load cell, a 5 cm gauge length, and a crosshead
speed of 5 cm/sec. Each specimen was stretched to failure, wherein
the sutures tore through the tissue to the wound and the two pieces
of tissue separated, and the maximum load was recorded.
[0088] The average peak forces required to separate the pig
intestinal wounds are shown in Table 2:
TABLE-US-00002 TABLE 2 Sutures, size 0 Tissue Holding Capacity
(lb.) Barbed PDO, A with terminal J-Stitch 7.64 .+-. 1.39 Barbed
PDO, A without terminal J-Stitch 4.53 .+-. 1.07 Barbed PDO, B with
terminal J-Stitch 8.40 .+-. 1.83 Control PDS II 6.61 .+-. 2.02
[0089] By comparison with the U.S. Pharmacopoeia minimum knot-pull
tensile strength requirement of size 0 absorbable sutures, 8.60
lb., the tensile strength of barbed PDO Design A, appears inferior.
However, the Design A wound holding capacity using a terminal
J-stitch compares favorably to that of the same-size control in the
pig intestinal model (p=0.19). Further, Design B with a terminal
J-stitch not only exceeds the U.S. Pharmacopoeia requirement, but
also demonstrates a trend toward higher mechanical performance than
the conventional suture. The wound holding strength omitting the
J-stitches and using Design A was inferior to the holding capacity
of Design A with J-stitches. Some of this reduction may be the
result of the shorter length of suture in the tissue with
J-stitches omitted, but it is believed that most of the difference
is the result of omitting the J-stitch configuration.
[0090] Although the present invention has been shown and described
in considerable detail with respect to only a few exemplary
embodiments thereof, it should be understood by those skilled in
the art that we do not intend to limit the invention to the
embodiments shown and described since various modifications,
omissions and additions may be made to the disclosed embodiments
without materially departing from the novel teachings and
advantages of the invention, particularly in light of the foregoing
teachings. For example, the barbed sutures with one or more
J-stitches and S-stitches and the single-directional sutures with
anchors may be used in a wide variety of applications, including
but not limited to Nissen fundoplications, stabilization of bowel
structures during laparoscopic surgery, appendectomy, Zenker's
Diverticulum surgery, urinary bladder cystostomy, securing a
replacement heart valve, securing external devices to tissue, and
closing axial wounds in blood vessels. Accordingly, we intend to
cover all such modifications, omission, additions and equivalents
as may be included within the spirit and scope of the
invention.
* * * * *