U.S. patent application number 12/849895 was filed with the patent office on 2010-11-25 for suture with a pointed end and an anchor end and with equally spaced tissue grasping protrusions located at successive axial locations.
This patent application is currently assigned to QUILL MEDICAL, INC.. Invention is credited to Gregory L. Ruff.
Application Number | 20100298637 12/849895 |
Document ID | / |
Family ID | 46255718 |
Filed Date | 2010-11-25 |
United States Patent
Application |
20100298637 |
Kind Code |
A1 |
Ruff; Gregory L. |
November 25, 2010 |
SUTURE WITH A POINTED END AND AN ANCHOR END AND WITH EQUALLY SPACED
TISSUE GRASPING PROTRUSIONS LOCATED AT SUCCESSIVE AXIAL
LOCATIONS
Abstract
A tissue connector has a first pointed end, an anchor end, a
body with a periphery and a plurality of protrusions projecting
from said periphery of said body. The plurality of protrusions are
adapted to grasp tissue in a direction of movement of the first end
of the connector through tissue and are not adapted to grasp tissue
in an opposite direction of movement of the connector through
tissue, which is in the direction of the anchor end. At axial
locations of said body, three said protrusions are about equally
located about the periphery of said body. At axial locations on a
cylindrical periphery of the body protrusions are locate at about
120 degree spacings.
Inventors: |
Ruff; Gregory L.; (Chapel
Hill, NC) |
Correspondence
Address: |
ANGIOTECH
P. O. BOX 2840
NORTH BEND
WA
98045
US
|
Assignee: |
QUILL MEDICAL, INC.
|
Family ID: |
46255718 |
Appl. No.: |
12/849895 |
Filed: |
August 4, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11968494 |
Jan 2, 2008 |
7806908 |
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12849895 |
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11747085 |
May 10, 2007 |
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11968494 |
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10420119 |
Apr 21, 2003 |
7226468 |
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11747085 |
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09629428 |
Jul 31, 2000 |
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10420119 |
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08324529 |
Oct 18, 1994 |
6241747 |
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09629428 |
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08055989 |
May 3, 1993 |
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08324529 |
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Current U.S.
Class: |
600/104 ;
606/228; 606/230 |
Current CPC
Class: |
A61B 17/064 20130101;
A61B 17/06109 20130101; A61B 2017/06176 20130101; A61B 17/083
20130101; A61B 2017/0647 20130101; A61B 17/10 20130101; A61B
17/0493 20130101 |
Class at
Publication: |
600/104 ;
606/228; 606/230 |
International
Class: |
A61B 17/04 20060101
A61B017/04; A61B 1/00 20060101 A61B001/00; A61L 17/06 20060101
A61L017/06 |
Claims
1. A tissue connector comprising: an elongated body with a circular
cross-sectional shape having a first end, a second end, a circular
periphery, and a plurality of protrusions extending from said
circular periphery of the body, wherein said protrusions extend
along a portion of said body and face the first end, the
protrusions are adapted to grasp tissue in a direction of movement
of the first end of the connector through tissue and are not
adapted to grasp tissue in an opposite direction of movement of the
connector through tissue; wherein at each of a plurality of axial
locations of said body, said protrusions face said first end and
are about equally and circumferentially spaced about the circular
periphery of the body, and said first end including a pointed end,
and said second end including a head.
2. The tissue connector of claim 1 wherein: said head includes an
anchor which is adapted to prevent tissue from going past said
head.
3. The tissue connector of claim 1 wherein: said head is larger
than a diameter of said elongated body and said head is adapted to
prevent tissue from going past said head.
4. The tissue connector of claim 1 wherein: said head is adapted to
have tissue located below said head.
5. The tissue connector of claim 1 wherein: said head is adapted to
be located above tissue.
6. The tissue connector of claim 1 and including: a cannula through
which said tissue connector is adapted to be deployed into
tissue.
7. The tissue connector of claim 1 and including: a cannula through
which said tissue connector is adapted to be deployed into tissue
during an endoscopic procedure.
8. The tissue connector of claim 1 wherein: said protrusions are
arranged on said periphery and adapted to lessen a tendency of said
connector to damage tissue.
9. The tissue connector of claim 1 wherein: said protrusions are
conical.
10. The tissue connector of claim 1 wherein: said connector is made
of a bioabsorbable material.
11. The tissue connector of claim 1 wherein: said protrusions are
arranged in a helical pattern.
12. The tissue connector of claim 1 wherein: said protrusions have
a non-uniform configuration.
13. The tissue connector of claim 1 wherein: said protrusions are
located in staggered positions about said periphery of said
connector.
14. The tissue connector of claim 1 wherein: said pointed end is
free of protrusions.
15. The tissue connector of claim 1 wherein said protrusions are
barbs.
16. The tissue connector of claim 1 wherein said protrusions are
tissue holding elements.
17. The tissue connector of claim 1 wherein at said axial locations
of the plurality of axial locations, three said protrusions are
about equally and circumferentially spaced about the circular
periphery of the body.
18. A tissue connector comprising: an elongated body with a
circular cross-sectional shape having a first end, a second end, a
circular periphery, and a plurality of protrusions extending from
said circular periphery of the body, wherein said protrusions
extend along a portion of said body and faces said first end, the
protrusions are adapted to grasp tissue in a direction of movement
of the first end of the connection through tissue and are not
adapted to grasp tissue in an opposite direction of movement of the
connection through tissue; and wherein at each of a plurality of
axial locations of said body, said protrusions face said first end
and are about equally and circumferentially spaced about the
circular periphery of the body, and said first end including a
pointed end, and said second end including a head; and said head is
larger than a diameter of said elongated body and said head is
adapted to prevent tissue from going past said head such that said
head is adapted to be located adjacent to tissue.
19. The tissue connector of claim 18 wherein: said head includes an
anchor.
20. The tissue connector of claim 18 wherein at said axial
locations of the plurality of axial locations, three said
protrusions are about equally and circumferentially spaced about
the circular periphery of the body.
Description
CLAIM TO PRIORITY
[0001] This application is a continuation of U.S. application Ser.
No. 11/968,494, filed Jan. 2, 2008, now allowed; which is a
continuation of U.S. application Ser. No. 11/747,085, filed May 10,
2007, now pending; which is a continuation of U.S. application Ser.
No. 10/420,119, filed Apr. 21, 2003, now U.S. Pat. No. 7,226,468,
issued Jun. 5, 2007; which is a continuation of U.S. application
Ser. No. 09/629,428, filed Jul. 31, 2000, now abandoned; which is a
continuation of U.S. application Ser. No. 08/324,529, filed Oct.
18, 1994, now U.S. Pat. No. 6,241,747, issued Jun. 5, 2001; which
is a continuation-in-part of U.S. application Ser. No. 08/055,989,
filed May 3, 1993, now abandoned. All the above claimed priority
applications are incorporated herein by reference in their
entireties.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] This invention relates to a barbed tissue connector, and
more particularly, to such a connector which can be used to quickly
and effectively close a body wound.
[0004] 2. Description of the Prior Art
[0005] Human wounds are typically repaired with a filament
introduced into the tissue by a needle attached to one end. After
piercing the opposing faces of the wound, the needle is removed,
and the ends of the suture are tied together with at least three
overhand knots. Such a technique requires considerable time and
expertise on the part of the surgeon. There are also a number of
other drawbacks to repairing a wound in this manner. For example,
it is very difficult to use sutures to repair wounds where there is
insufficient space to properly manipulate the suture, especially
those wounds repaired using fiber optic visualization. The suture
forms a loop as it is tied, and this loop constricts blood flow to
the tissue in its confines, promoting necrosis of the wound
margins. Further, if the needle's passage was noncircular, the
tissue will be distorted as it is secured by the suture.
[0006] Alternatives to conventional sutures are known in the prior
art. Staples, as shown, for example, in U.S. Pat. No. 4,994,073, to
Green, are often used for approximating the superficial layer of
the wound. Staples, however, are generally unsuitable for deeper
layers of tissue.
[0007] The patent to Alcamo, U.S. Pat. No. 3,123,077, discloses a
roughened suture which can be passed through tissue in one
direction, but resists movement in the opposite direction. The
Alcamo suture, however, still must be sewn, as by a conventional
technique, and the trailing end must be secured with knots. Thus,
although there is less slippage of the suture in the wound, most of
the disadvantages of sutures noted above are also found in the
Alcamo suture.
[0008] The patent to Tanner, U.S. Pat. No. 3,716,058, discloses a
relatively rigid suture with one or more barbs on opposite ends of
an arcuate body. One disadvantage of the Tanner suture is that the
rigid barbs, which protrude from the suture as it is inserted, will
lacerate tissue and prevent retrograde repositioning. Further,
since the barbs are only placed at the ends of the suture, the
forces applied to the tissue by the barbs will be limited to a
relatively small area; this substantially increases the pressure on
the blood vessels ensnared by a barb and severely restricts blood
flow to the area.
[0009] It will be seen from the foregoing that there is a need for
a tissue connector which can be placed more expeditiously than
sutures, is self-retaining, obviates distortion of the tissue, can
close tissue inaccessible to conventional procedures, and which
preserves blood flow by broadly distributing the retention
force.
SUMMARY OF THE INVENTION
[0010] It is an object of the present invention to overcome the
aforementioned problems in the prior art and to provide an improved
tissue connector.
[0011] In accordance with the present invention there is provided a
barbed tissue connector comprising: an elongated body having a
point formed on one end, the body being formed of a material
sufficiently hard for the point to pierce tissue and enable the
connector to be inserted in tissue when a substantially axial force
is applied to the body; and a plurality of barbs projecting from
the body, the barbs being disposed around the periphery of the body
along a length of the body which extends from adjacent the one end
to a predetermined location on the body, the barbs being configured
such that they are yieldable in a direction toward the body and are
generally rigid in an opposite direction, and the barbs being
sufficiently resilient to return to a predetermined position after
deflection therefrom.
[0012] In one embodiment of the present invention, the barbed
tissue connector includes an elongated body and a plurality of
barbs which are disposed in a helical pattern on the body and
extend from a pointed end of the connector to a predetermined
location on the body. Each barb includes a first side, which forms
an obtuse angle with the body, and a second side which forms an
acute angle with the body. The body is substantially rigid and
sufficiently resilient to return to a predetermined position after
deflection therefrom. When the connector is inserted in tissue to
repair a wound, the pointed end pierces tissue and the barbs yield
toward the body to facilitate entry of the connector.
[0013] When the connector has been placed in a desired position in
tissue, the barbs strongly resist movement away from this position.
The connector can be inserted by gripping the connector in the hand
and pushing the connector into the tissue, or the connector can be
inserted by means of an inserting device which is withdrawn when
the connector is in place.
[0014] A principal advantage of the barbed tissue connector of the
present invention is that it permits a surgeon to rapidly and
securely attach the edges of a wound in human tissue without the
necessity for threading and tying numerous individual stitches or
for the use of a complicated or elaborate tool to insert the
connector. The connector is configured to minimize damage to tissue
when inserted and to minimize scarring or tissue necrosis across
the wound. The connector is capable of insertion into the faces of
a wound, can connect tissue at the bottom of a deep wound, and can
connect tissue which is inaccessible to a staple. Finally, the
connector of the present invention can be inserted quickly and
accurately by a surgeon who only has access to tissue from a small
opening or from only one direction, as, for example, during an
endoscopic procedure.
[0015] Other features and advantages will become apparent upon
reference to the following description of the preferred embodiment
when read in light of the attached drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] FIG. 1 is a side view of the connector of the present
invention, with a section broken away to more clearly show the
arrangement of the barbs;
[0017] FIG. 2 is an end view of the connector shown in FIG. 1;
[0018] FIG. 3 is a side view of another embodiment of the present
invention, with a section of a connector broken away;
[0019] FIG. 4 is a side view of another embodiment of the present
invention;
[0020] FIG. 5 is a side view of another embodiment of the present
invention;
[0021] FIG. 6 is a side view of another embodiment of the present
invention;
[0022] FIG. 7 is a sectional view taken along the line 7-7 in FIG.
6;
[0023] FIG. 8 is a side view of another embodiment of the present
invention;
[0024] FIG. 9 is a sectional view taken along the line 9-9 in FIG.
8;
[0025] FIG. 10 is a perspective view of an inserting device for use
with a barbed tissue connector of the present invention; and
[0026] FIG. 11 is a view showing the inserting device and connector
in a wound.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0027] The present invention allows a surgeon to rapidly and
securely attach the edges of a wound in human tissue without the
necessity for threading and tying numerous individual stitches or
for using a complicated or elaborate tool. As used herein, the term
"wound" means an incision, laceration, cut, or other condition
where suturing, stapling, or the use of another tissue connecting
device might be required.
[0028] With reference to FIGS. 1 and 2, there is shown a barbed
tissue connector 2 constructed in accordance with the present
invention. Connector 2 includes a body 4 which is generally
circular in cross section and a plurality of closely-spaced barbs 6
which extend around the periphery of the body 4. A pointed end 9 is
formed on the body 4 to facilitate penetration of the connector 2
into tissue. The body 4 preferably has sufficient dimensional
stability to assume a substantially rigid configuration during use
and is sufficiently resilient to return to a predetermined shape
after deflection therefrom. In some applications, it may be
desirable for the body 4 to be flexible and substantially
nonresilient so that the shape of an inserted connector will be
determined by surrounding tissue.
[0029] Barbs 6 serve to hold the connector in tissue and resist
retraction of the connector from the tissue. The barbs 6 can be
arranged in any suitable pattern, for example, in a helical pattern
as shown in FIG. 1. In a helical pattern of barbs 6, it is
preferable that the number of barbs occupying one revolution not be
an integer, thereby avoiding parallel axial rows of barbs; such an
arrangement provides a more uniform distribution of forces on the
tissue and lessens the tendency of an inserted connector 2 to cut
through tissue. If the number of barbs in one revolution is not an
integer, the barbs in successive revolutions will be offset, as
shown in FIG. 2, and the amount of offset will determine which
barbs are in axial alignment. For example, if the barbs in
successive revolutions are offset by 1/2 barb, the barbs in every
second revolution will be in axial alignment, and by extension, if
the barbs in each successive revolution are offset by 1/x barb, the
barbs in every x revolution will be in axial alignment.
[0030] As shown in FIG. 1, each barb 6 includes a first side 8
which forms an obtuse angle alpha with the body 4 and a second side
10 which forms an acute angle beta with the body 4. Each barb 6
tapers to a point 7, and the amount of difference between the angle
alpha of side 8 and angle beta of side 10 will control the amount
of taper in the barb 6. A barb 6 which tapers from a broad base to
a narrow tip can be effective in resisting retraction, yet will
yield toward the body 4 during insertion to reduce the effort and
tissue damage associated with insertion of the connector 2. The
barbs 6 can be generally conical, as shown in FIG. 1, or they can
be any other shape which will function in substantially the same
manner as the conical barbs.
[0031] The configuration of barbs 6 and the surface area of the
barbs can vary depending upon the tissue in which the connector 2
is used. The proportions of the barbs 6 can remain relatively
constant while the overall length of the barbs and the spacing of
the barbs are determined by the tissue being connected. For
example, if the connector 2 is intended to be used to connect the
edges of a wound in skin or tendon, each barb 6 can be made
relatively short to facilitate entry into this rather firm tissue.
If the connector 2 is intended for use in fatty tissue, which is
relatively soft, the barbs can be made longer and spaced farther
apart to increase the holding ability in the soft tissue. As shown
in FIG. 1, the barbs 6 on connector 2 have a uniform unidirectional
configuration, that is, the barbs 6 are uniformly spaced on body 4
and all the sides 8 are oriented in the same direction, facing
pointed end 9. Connector 2 can be inserted into tissue with the
sides 8 of each barb 6 facing in the direction of motion. Connector
2 will prevent movement of tissue in the direction in which it was
inserted. A pair of connectors 2 inserted adjacent to each other
and in opposite directions will prevent movement of tissue in
either direction across a wound.
[0032] Connector 2 can be formed of a material sufficiently hard
for point 9 to pierce tissue and enable the connector to be
inserted in tissue when a substantially axial force is applied to
body 4. Connector 2 is preferably composed of a bioabsorbable
compound, such as a polyglycolic acid or polylactic acid polymer or
copolymer. The use of a bioabsorbable material eliminates the
necessity of removing the connector from the patient, which can be
a painful and possibly dangerous process. Connector 2 can be
formed, for example, by injection molding.
[0033] In one representative example of connector 2 for use in
muscular tissue, the body 4 is formed from polyglycolic acid, has a
length of 1 to 5 cm, and a diameter of about 1 mm. The diameter of
a circle extending around points 7 of barbs 6 will be about 3 mm,
and the barbs are spaced apart from each other on body 4 by a
distance of 1 mm. Side 8 forms an angle of 135 degrees with the
body 4 and side 10 forms an angle of 75 degrees with the body
4.
[0034] In FIG. 3, there is shown a second embodiment of the present
invention in which barbs 16 are arranged in a uniform bidirectional
configuration on a barbed tissue connector 12. Barbs 16 are
constructed in the same manner as barbs 6 on connector 2. A first
set of barbs 15 on connector 12 are arranged in a helical pattern
and face a pointed end 20, and a second set of barbs 16 on
connector 12 are arranged in a helical pattern and face a pointed
end 21. Each of the pointed ends 20, 21 should be sufficiently hard
and sharp to easily penetrate tissue in which the connector is to
be used. Connector 12 is particularly suitable for applications
where the edges of a wound are prone to separate. Connector 12 can
be used by inserting one of the ends, for example end 20, into a
first side of a wound (not shown), spreading the wound slightly to
expose the second side of the wound, inserting the end 21 of the
connector 12 into the second side of the wound, and then pressing
the edges of the wound together. The barbs 15 and 16 on the ends of
the connector 12 will grasp the tissue on each side of the wound
and prevent the edges of the wound from spreading.
[0035] With reference to FIG. 4, there is shown another embodiment
of the present invention in which a barbed tissue connector 22 has
a nonuniform bidirectional configuration. Connector 22 comprises a
pointed end 23 and one or more barbs 26 facing a first direction
which alternate with one or more barbs 27 facing a second
direction. At each axial location, there can be a number, e.g. 4-9,
of circumferentially-spaced barbs 26 or 27. To insert connector 22
into tissue, the surgeon would use an inserting device 80 as
described below. The arrangement of barbs 26, 27 on connector 22
would prevent any localized movement of tissue relative to the
connector in an axial direction.
[0036] With reference to FIG. 5, there is shown another embodiment
of the present invention in which a barbed tissue connector 32 has
a uniform bidirectional configuration. Connector 32 comprises a
body 34 having pointed ends 33 and 35. A plurality of
axially-spaced barbs 36 adjacent pointed end 33 face toward end 35,
and a plurality of axially-spaced barbs 37 adjacent pointed end 35
face toward end 33. Barbs 36 and 37 can be circumferentially-spaced
around body 34 at each axial location, or the barbs 36 and 37 can
be of the same construction and arranged in the same pattern as
barbs 6 on connector 2. To insert a connector 32, the surgeon would
use an inserting device 80 as described below. If the body 34 of
the connector 32 is sufficiently rigid, the connector 32 would
prevent tissue retained by the barbs 36 from moving toward end 35
and tissue retained by barbs 37 from moving toward end 33. It will
be apparent that only one end of connector 32 needs to be pointed;
two pointed ends are preferable, however, so that the surgeon does
not have to take the time to insure that connector 32 is oriented
in the inserting device 80 with a pointed end protruding from the
inserting device.
[0037] With reference to FIGS. 6 and 7, there is shown another
embodiment of the present invention in which a barbed tissue
connector 42 comprises a body 44 having a pointed end 45 for
penetration into tissue. A head 47 is formed on an opposite end of
body 44. A plurality of circumferentially-spaced barbs 46 are
formed on body 44 at each of a number of axial locations. As shown
in FIG. 7, three barbs 46 are formed at each axial location;
however, more or less than three barbs 46 could be used for certain
applications. Barbs 46 include a first side 48 formed at an obtuse
angle to the body 44 and a second side 49 which projects from body
44 at an acute angle. The connector 42 can be forced into tissue by
applying a force to the head 47. The connector 42 can be applied by
hand, or it can be inserted using an inserting device 80 as
described below.
[0038] The connector 42 can be formed entirely of a bioabsorbable
material, or the head 47 and the body 44 can be composed of
different materials. For example, the body 44 can be composed of a
bioabsorbable material, and the head 47 can be composed of metal
for superior strength and to facilitate insertion of the connector
42. Head 47 can be made flat, as shown in FIG. 6, or the head can
be formed by a single ring of barbs (not shown) facing in a
direction opposite to that of the barbs 46.
[0039] In use, a series of connectors 42 can be inserted into
tissue, such as along the edges and in the field of a skin graft.
After an adequate amount of time has passed for the wound to heal,
the tissue beneath each head 47 could be depressed slightly to
permit the head 47 to be cut from the body 44. The tissue would
then rise up over the cut end of the body. Such a process would
reduce scarring which could result from a long-term projection of
the body 44 through tissue and would eliminate the necessity to
remove connectors 42 from the patient.
[0040] With reference to FIGS. 8 and 9, there is shown another
embodiment of the present invention in which a barbed tissue
connector 52 has a uniform unidirectional configuration. Connector
52 comprises a body 54 having a non-circular cross-sectional shape.
Body 54 includes a plurality of barbs 56 which are generally
triangular in cross section and are equally spaced around the
periphery of the body at a series of axial locations. Each of the
barbs 56 includes a first side 58 disposed at an obtuse angle to
body 54 and a second side 60 disposed at an acute angle to the
body. Body 54 includes a pointed end 53 to facilitate entry in
tissue. Use of a non-circular cross-sectional shape increases the
surface area of the connector 52 and facilitates the formation of
the multiple barbs on the connector. For example, barbs 56 can be
formed on a piece of stock having a triangular cross section by
removing material at successive axial locations from the three
edges of the stock. It will be apparent that a similar process
could be used to form barbs on stock of a different cross section
(not shown), for example, a rectangular or hexagonal cross
section.
[0041] In the use of the disclosed connectors, such as connectors 2
and 42, the surgeon can grip the connector in one hand and push the
connector into the tissue. As an alternative to directly inserting
the connectors into the tissue, the surgeon can use an inserting
device 80 as shown in FIGS. 10 and 11. The inserting device 80
comprises a circular tubular body 82. The tubular body 82 can be
generally arcuate in an axial direction, and the body 82 is
sufficiently long to contain at least a portion of a barbed tissue
connector C. Device 80 has an inwardly tapered leading end 84 and
an outwardly tapered, or flared, trailing end 86. A handle 83 is
provided on body 82 adjacent trailing end 86 to enable the surgeon
to manipulate the inserting device 80.
[0042] In order to facilitate entry of the connector C and the
device 80 into tissue, a connector C is positioned in tubular body
82 with a pointed end P of the connector C extending from leading
end 84. In a preferred embodiment, the interior diameter of the
body 82 is made slightly smaller than the outside diameter of the
connector C so that the barbs B of a connector C in the body 82
will press against the body 82; as a result, the connector C will
be retained in the body 82 during insertion in tissue with the
point P properly positioned outside of the body 82. The connector
can also be positioned in body 82 with a barb B outside of body 82
to insure that the connector C will not be pushed back in the body
82 during insertion. In one application of device 80, the surgeon
inserts the body 82 having connector C therein into the patient's
tissue 87 until the connector C reaches a desired position, for
example, the position shown in FIG. 11. Device 80 is then withdrawn
in the direction of arrow 90, and a barb, or barbs, B on the
connector C penetrates and catches the tissue 87 to hold the
connector C in the inserted position.
[0043] Use of the inserting device 80 is particularly recommended
when the connector C includes multiple barbs facing more than one
direction, such as connectors 22 and 32, or when the connector is
too flexible for insertion without additional support.
[0044] While the present invention has been described with respect
to certain preferred embodiments thereof, it is to be understood
that numerous variations in the details of construction, the
arrangement and combination of parts, and the type of materials
used may be made without departing from the spirit and scope of the
invention.
* * * * *