U.S. patent application number 13/233607 was filed with the patent office on 2012-01-05 for system and method of making tapered looped suture.
This patent application is currently assigned to Tyco Healthcare Group LP, North Haven, CT. Invention is credited to William R. Bowns, Nicholas Maiorino.
Application Number | 20120004686 13/233607 |
Document ID | / |
Family ID | 41441047 |
Filed Date | 2012-01-05 |
United States Patent
Application |
20120004686 |
Kind Code |
A1 |
Maiorino; Nicholas ; et
al. |
January 5, 2012 |
System and Method of Making Tapered Looped Suture
Abstract
A system for forming a looped suture having a tapered cut is
provided. The system includes a base for selectively retaining a
portion of thread, a clamping device for receiving a first end of
the thread, a tensioning device for receiving a second end of the
thread, a welding assembly configured to join a first and second
section of the thread to form a loop, and a cutting assembly
configured to form a tapered end on the first section of the
thread.
Inventors: |
Maiorino; Nicholas;
(Branford, CT) ; Bowns; William R.; (Ansonia,
CT) |
Assignee: |
Tyco Healthcare Group LP, North
Haven, CT
|
Family ID: |
41441047 |
Appl. No.: |
13/233607 |
Filed: |
September 15, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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12548607 |
Aug 27, 2009 |
8056599 |
|
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13233607 |
|
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61099594 |
Sep 24, 2008 |
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Current U.S.
Class: |
606/228 ;
156/168 |
Current CPC
Class: |
A61B 2017/0619 20130101;
A61B 17/06166 20130101; A61B 2017/00526 20130101; B29C 66/69
20130101; B29C 65/08 20130101; Y10T 156/1064 20150115; Y10T 156/12
20150115; Y10T 156/1702 20150115; B29C 66/8322 20130101; Y10T
156/1378 20150115; Y10T 156/1082 20150115 |
Class at
Publication: |
606/228 ;
156/168 |
International
Class: |
A61B 17/04 20060101
A61B017/04; B32B 38/10 20060101 B32B038/10 |
Claims
1-15. (canceled)
16. A method of forming a loop in a suture, the method comprising
the step of: providing a loop forming system including, a base for
securely retaining the suture to be formed, a welding assembly for
forming a loop in the suture, and a cutting assembly for forming a
taper on an surface of the loop; securing a portion of the suture
to the base such that a first section of the suture is maintained
adjacent to a second section of the suture; approximating the
welding assembly and the base towards each other; approximating the
welding assembly and base away from each other; approximating the
cutting assembly and the base towards each other; and cutting a
tapered surface on a proximal end of the first section of the
suture; approximating the cutting assembly and base away from each
other; and removing the formed suture from the base.
17. The method of claim 16, wherein the loop forming system further
includes a clamping device for receiving a first end of a
suture.
18. The method of claim 16, wherein the loop forming system further
includes a tensioning device for tensioning the suture once the
suture is retained in the base.
19. A medical device formed from the method claim 16.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] The present application claims benefit to and priority from
U.S. Provisional Application Ser. No. 61/099,594, filed Sep. 24,
2008, the entire content of which is incorporated herein by
reference.
BACKGROUND
[0002] 1. Technical Field
[0003] The present disclosure relates to a method of forming a
looped suture. More particularly, the present disclosure relates to
a method of forming a looped suture having a tapered surface.
[0004] 2. Background of Related Art
[0005] A method for forming a loop in a suture during a wound
closing procedure (surgery) is known. It would be beneficial to
have a system and method for more effectively forming a loop on a
suture prior to engagement of tissue with the suture. It would be
further beneficial if the system and method could form a tapered
end on the loop.
SUMMARY
[0006] Accordingly, a system for forming a looped suture having a
tapered surface is provided. The system includes a base for
selectively retaining a portion of thread, a clamping device for
receiving a first end of the thread, a tensioning device for
receiving a second end of the thread, a welding assembly configured
to join a first and second section of the thread to form a loop,
and a cutting assembly configured to form a tapered end on the
first section of the thread.
[0007] The base may include a suture nest, a pin retaining member,
a pin, and a pin locking member. The base may include at least one
channel for receiving at least a portion of the second section of
the thread. The pin retaining member may be pivotally mounted to
the base. The pin may be configured to receive a portion of the
thread thereabout. The welding assembly of the system may be
configured to weld using ultrasonic energy.
[0008] The cutting assembly of the system may be configured to cut
using one of ultrasonic energy, blades and lasers. The cutting
assembly may be configured to form a tapered end on the first
section of thread that is generally linear or generally curved. The
cutting assembly may be configured to form a tapered end on the
first section of thread that is convex or concave. The cutting
assembly may also be configured to form a tapered end on the first
section of thread that is angled downwards towards a longitudinal
axis of the elongate body. Furthermore, the cutting assembly may be
configured to form a tapered end on the first section of thread
that forms an angle of about zero degrees (0.degree.) to about
ninety degrees (90.degree.), preferably, five degrees (5.degree.)
to about thirty degrees (60.degree.), relative to a longitudinal
axis of the elongated body. In addition, the cutting assembly may
be configured to form a tapered end on the first section of thread
that is suitable for penetrating tissue.
[0009] Further provided is a method of forming a loop in a suture
thread. The method includes the steps of providing a loop forming
system including, a base for securely retaining a thread to be
formed, a welding assembly for forming a loop in the thread, and a
cutting assembly for forming a taper on an end of the loop,
securing a portion of the thread to the base such that a first
section of the thread is maintained adjacent to a second section of
the thread, approximating the welding assembly and the base towards
each other, approximating the welding assembly and base away from
each other, approximating the cutting assembly and the base towards
each other, and cutting a tapered end on a proximal end of the
first section of the thread, approximating the cutting assembly and
base away from each other, and removing the formed suture from the
base.
[0010] The loop forming system of the method may further include a
clamping device for receiving a first end of a thread. The loop
forming system may further include a tensioning device for
tensioning a thread once the thread is retained in the base.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] The accompanying drawings, which are incorporated in and
constitute a part of this specification, illustrate embodiments of
the disclosure and, together with a general description of the
disclosure given above, and the detailed description of the
embodiment(s) given below, serve to explain the principles of the
disclosure, wherein:
[0012] FIG. 1A is a side view of a looped suture including a
tapered portion;
[0013] FIG. 1B is a cross-sectional end view of the looped suture
of FIG. 1A, taken along line 1B-1B;
[0014] FIG. 1C is an enlarged side view of portion 1C of FIG.
1A;
[0015] FIG. 2A is a front view of a base used in the tapered loop
forming method of the present disclosure;
[0016] FIG. 2B is a side view of the base of FIG. 2A;
[0017] FIG. 2C is a top view of the base of FIGS. 2A and 2B;
[0018] FIG. 3A is a side view of the base of FIGS. 2A-2C loaded
with a suture and including a welding assembly, a suture retaining
assembly and a suture tensioning assembly;
[0019] FIG. 3B is a top view of the loaded base of FIG. 3A;
[0020] FIG. 3C is a cross-section front view of the loaded base of
FIGS. 3A and 3B;
[0021] FIGS. 4A and 4B are enlarged views of FIG. 3C, with the
suture in a pre-welded (FIG. 4A) and post-welded (FIG. 4B)
configuration;
[0022] FIG. 5A is a top view of the loaded base of FIGS. 3A-3C,
post-welding and prior to the tapered cut being formed;
[0023] FIG. 5B is a cross-sectional front view of the loaded base
of FIG. 5A;
[0024] FIG. 5C is a cross-sectional side view of the loaded base of
FIGS. 5A and 5B;
[0025] FIG. 6A is a cross-sectional front view of the loaded base
of FIGS. 5A-5C, post-welding and post-cutting of the suture;
[0026] FIG. 6B is a cross-sectional side view of the loaded base of
FIG. 6A.
DETAILED DESCRIPTION
[0027] A method for forming a looped suture including a tapered
surface is herein described. Referring initially to FIG. 1A, a
looped suture formed in accordance with the method of the present
disclosure is shown generally as looped suture 10. Suture 10 is
formed from a monofilament thread 11; however, it is envisioned
that suture 10 may be formed braided threads, multifilament threads
and other surgical fibers. Although shown having a circular
cross-sectional geometry, the cross-sectional geometry of thread 11
may be of any suitable shape, such as, round, elliptical, square,
flat, octagonal, and rectangular. Thread 11 may be formed of
degradable materials, non-degradable materials, and combinations
thereof. Thread 11 may be formed using any technique within the
purview of those skilled in the art, such as, for example,
extrusion, molding and/or gel spinning.
[0028] With reference to FIGS. 1A and 1B, looped suture 10 includes
a loop 12 formed on a distal end 10b thereof. Loop 12 forms a
substantially teardrop shape and may be formed of any size. A first
section 13 of monofilament thread 11 overlays a second section 14
of thread 11 to form loop 12. The adjacent surfaces of first and
second sections 13, 14 form a joined segment or joint 15. As shown,
joined segment 15 extends beyond first section 13 of thread 11. In
this manner, first and second sections 13, 14 of thread 11 are less
likely to separate or peel away from each other as looped suture 10
is pulled through tissue (not shown).
[0029] As will be described in further detail below, first and
second sections 13, 14 of thread 11 are welded together to form
joined section 15. Energy is locally applied to first and second
sections 13, 14 of thread 11 fusing sections 13, 14 together to
form joined segment 15. Various types of energy may be applied to
first and second sections 13, 14 to form joined segment 15,
including, radio frequency (RF), ultrasonic, laser, electrical arc
discharge, and thermal. Alternatively, first and second sections
13, 14 of thread 11 may be joined using glues, epoxies, solvents,
or other adhesives.
[0030] With particular reference to FIG. 1C, a proximal end 13a of
first section 13 is angled to form a tapered surface 17. Tapered
surface 17 angles downwardly towards proximal end 10a of looped
suture 10. Tapered surface 17 may form an angle a relative to a
longitudinal axis "X" of second section 14, between zero degrees
(0.degree.) and ninety degrees (90.degree.), and preferably between
about five degrees (5.degree.) to about thirty degrees
(60.degree.). Tapered surface 17 facilitates insertion of loop 12
into or through tissue. Tapered surface 17 may be formed prior to,
during or following the joining of first and second sections 13,
14. In one embodiment, tapered surface 17 is formed such that
joined segment 15 extends beyond first section 13 of thread 11. In
this manner, tapered surface 17 forms a smooth transition with
second section 14 of thread 11, thereby decreasing the likelihood
that first and second sections 13, 14 might separate or peel away
from each other as looped suture 10 is pulled through tissue.
[0031] Although shown having a substantially planar taper, tapered
surface 17 may include any number of configurations. For example,
tapered surface 17 may be beveled, may include a laterally and
longitudinally concave taper, may include a laterally and
longitudinally convex taper, or may include any combination
thereof. Tapered surface 17 may be selected depending on the tissue
being sutured and/or the depth loop 12 is desired to be received
within the tissue.
[0032] A system for forming loop 12 on distal end 10b of looped
suture 10 will now be described with reference to FIGS. 2A-6B, and
is shown generally as system 100. System 100 includes a fixture
member or base 110, a suture retaining member 120 (FIG. 3A), a
suture tensioning member 125 (FIG. 3A), a welding assembly 130
(FIGS. 3A-3C), and a cutting assembly 140 (FIGS. 5A-6B).
[0033] Referring initially to FIGS. 2A-2C, base 110 includes a
platform 112, a suture nest 114, a pin retaining member 116, a pin
116a extending from pin retaining member 116, and a pin lock 118.
Platform 112 includes one or more openings 112a for securing base
110 to a workstation (not shown) using bolts 112b or other fixation
means. As shown, suture nest 114 is integrally formed with platform
112. Alternatively, suture nest 114 may be releasably attached or
securely affixed to platform 112. Nest 114 includes one or more
channels 115 extending across a top surface 114a thereof. As will
be described in further detail below, channels 115 are configured
to partially receive a portion of suture thread 11, including
second section 14 (FIG. 1). Nest 114 may further includes raised
outer portions 113 extending along proximal and distal ends 115a,
115b of channels 115. Raised outer portions 113 include openings
113a configured to receive two lengths of suture thread 11,
adjacent to or on top of one another. As shown, suture nest 114
includes three channels 115; however, it is envisioned that suture
nest 115 may include one or more channels 115. In one embodiment,
suture nest 115 may be formed without a channel. In this manner,
the first and second portions of suture thread 11 would be received
in opening 113a and are maintained adjacent to one another through
the tension applied by suture tensioning means 125 (FIG. 3A).
[0034] Still referring to FIGS. 2A-2C, pin 116a extends from pin
retaining member 116. Pin retaining member 116 is pivotally
attached to platform 112 such that pin 116a may be selectively
positioned and securely retained perpendicular to channels 115
along an end thereof (FIG. 3B). Pin lock 118 is pivotally attached
to suture nest 114 and is configured to secure pin 116a in the
perpendicular position adjacent proximal end 115a of channels 115.
Alternatively, pin lock 118 may be integrally formed with suture
nest 114. In another alternate embodiment, pin retaining member 116
may be releasably attached or securely affixed to platform 112. The
diameter of pin 116a may be varied depending on the desired size of
loop 12.
[0035] Turning briefly to FIG. 3A, as discussed above, system 100
also includes a suture retaining means 120 and a suture tensioning
means 125. Suture retaining means 120 may include a clamp or other
device configured to retain a proximal end 11a of suture thread 11.
Suture tensioning means 125 may include a hydraulic or pneumatic
tensioning spring, electrical cylinder or other tensioning device
configured to receive a distal end 11b of suture thread 11 and to
apply tension to suture thread 11 once thread 11 has been secured
to suture nest 114. Suture retaining means 120 and suture
tensioning means 125 are positioned adjacent distal end 115b of
channel 115 to securely receive respective proximal and distal ends
11a, 11b of suture thread 11 during the forming of loop 12.
[0036] With reference to FIGS. 3A-4B, welding assembly 130 includes
an ultrasonic device 132 operably connected to a generator (not
shown) for ultrasonically vibrating a die 134 extending from
ultrasonic device 132. Die 134 defines a substantially flat suture
contacting portion 136. In an alternative embodiment, die 134 may
include a portion 136 configured to contour first section 13 of
suture thread 11. Thus, suture contacting portion 136 may include a
concave, convex or beveled surface to correspond with a suture
thread having a convex, concave or beveled profile. In one
embodiment, welding assembly 130 is operatively mounted on a press
assembly (not shown) for approximating die 134 of welding assembly
130 towards and away from base 110. Alternatively, welding assembly
130 may be securely mounted relative to base 110 and base 110 may
be raised and lowered to approximate base 110 towards and away from
die 134.
[0037] Turning now to FIGS. 5A-6B, cutting assembly 140 includes an
ultrasonic device 142 operably connected to a generator (not shown)
for ultrasonically vibrating a blade 144 extending from ultrasonic
device 142. The generator for ultrasonically vibrating die 134 may
be the same or a different generator as is operatively connected to
ultrasonic device 142 for ultrasonically vibrating blade 144. In
one embodiment, blade 144 defines a substantially flat cutting
surface 144a; however, it is envisioned that blade 144 may include
a cutting surface of alternative configurations. Blade 144 may be
configured to form a concave, convex, beveled or otherwise
configured taper 17 on looped suture 10. Although the following
discussion will relate to a cutting assembly that includes an
ultrasonic device 142, it is envisioned that cutting assembly 140
may be used without ultrasonically vibrating blade 144. In this
manner, blade 144 may be operably connected to a heater or other
apparatus for effecting cutting of suture thread 11. In yet another
embodiment, taper 17 on looped suture 10 may be cut using a
laser.
[0038] Still referring to FIGS. 5A-6B, in one embodiment, cutting
assembly 140 is securely mounted relative to base 144 such that
cutting assembly 140 is maintained stationary as base 110 is
approximated towards and away from blade 144. In an alternative
embodiment, cutting assembly 140 is selectively positioned relative
to base 110, such that cutting assembly 140 moved relative to base
110. In either embodiment, at least one of cutting assembly 140 and
base 110 is configured to move laterally with respect to the other
and approximate towards the other. When cutting assembly 140 is
maintained stationary, base 110 is configured to move laterally, in
the direction of arrow A1 (FIG. 6B) and towards cutting assembly
140, in the direction of arrow A2. When base 110 is maintained
stationary, cutting assembly 140 is configured to move laterally,
in the direction of arrow B1 and towards base 110, in the direction
of arrow A2. Movement of base 110 and/or cutting assembly 140 may
be computer controlled or may be effected manually.
[0039] The method of forming looped suture 10 utilizing system 100
will now be described with reference to FIGS. 3A-6B. Referring
initially to FIG. 3A, a proximal end 11a of thread 11 is securely
locked in a clamp 120. Second section 14 of thread 11 is then
positioned within a channel 115 of nest 114. Thread 11 is next
wrapped around pin 116a before first section 13 of thread 11 is
placed on top of or adjacent second section 14. A distal end 11b of
thread 11 is then received in tension cylinder 125. Tensioning
cylinder 125 is then activated to tension thread 11 within base
110. To prevent stretching of thread 11 during forming of looped
suture 10, and thereby ensuring consistency and integrity of thread
11, thread 11 may be formed of a pre-stretched material.
[0040] With particular reference now to FIGS. 3C-4B, once first and
second sections 13, 14 are positioned adjacent one another, welding
assembly 130 is approximated towards suture nest 114.
Alternatively, suture nest 114 may be approximated towards welding
assembly 130. As welding assembly 130 nears suture nest 114, first
section 13 of suture thread 11 is received within channel 136 of
die 134 until first section 13 engages suture contacting portion
136a of channel 136 (FIG. 4A). Ultrasonic device 132 may be
activated at any point during this process to ultrasonically
vibrate die 134. The downward pressure exerted on first and second
sections 13, 14 of thread 11 from the continued approximation of
die 134 towards nest 114 (FIG. 4B), in combination with ultrasonic
vibration of die 134, causes contacting portions of first and
second sections 13, 14 to locally heat, and, in some instances, the
contacting portions may begin to melt. Application of ultrasonic
energy to sections 13, 14 creates joined section 15.
[0041] Once first and second sections 13, 14 are fused to create
joined section 15, welding assembly 130 may be approximated away
from suture nest 114. With looped suture 10 remaining secured to
base 110, welding assembly 130 may then be replaced or exchanged
for cutting assembly 140 to complete the tapered cutting of
proximal end 13a of first section 13. Alternatively, looped suture
10 may be removed from base 110 and affixed to a separate mount
(not shown) to complete the taper forming process.
[0042] With reference now to FIGS. 5A-6B, once cutting assembly 130
is properly positioned in relation to base 110, base 110 is
approximated towards cutting assembly 140. Alternatively, cutting
assembly 140 may be approximated towards base 110. Ultrasonic
device 142 may be activated at any time prior to or during
approximation of cutting assembly 140 towards base 110. With
particular reference to FIG. 6B, the travel of base 110 in relation
to cutting assembly 140 includes an upward movement, as indicated
by arrow A.sub.1 and lateral movement, as indicated by arrow
A.sub.2. In an alternative embodiment, cutting assembly 140 is
moved in a downward movement, as indicated by arrow B.sub.1 and a
lateral movement, as indicated by arrow B.sub.2. The rate at which
base 110 moves relative to cutting assembly 140 may be varied
depending on the desired configuration of tapered surface 17 (FIG.
1C). In this manner, when the lateral movement is increased
relative to the up/down movement, tapered surface 17 defines an
angle a (FIG. 1C) of a lesser degree. Conversely, when the lateral
movement of is decreased relative to the up/down movement, angle a
of tapered surface 17 is increased. In either embodiment, cutting
assembly 130 and base 110 are approximated toward one another until
blade 144 completely severs first section 13 of thread 11. Distal
end 11b of thread 11 is then pulled away by tension cylinder
125.
[0043] Cutting assembly 130 and base 110 are then approximated away
from each other and looped suture 10 is removed from pin 116a.
Suture 10 may include flash or debris (not shown) formed during the
welding and/or cutting process. The flash may need to be removed
before looped suture 10 may be used.
[0044] Although the illustrative embodiments of the present
disclosure have been described herein with reference to the
accompanying drawings, it is to be understood that the disclosure
is not limited to those precise embodiments, and that various other
changes and modifications may be effected therein by one skilled in
the art without departing from the scope or spirit of the
disclosure. For example, it is envisioned that system 100 may
include more than one welding assembly 130 and a corresponding
number of cutting assemblies 140 to produce more than one suture 10
per activation. It is further envisioned that system 100 may
include a separate base for maintaining suture 10 during the
cutting process.
* * * * *