U.S. patent application number 11/127955 was filed with the patent office on 2006-01-05 for suture locking and cutting devices and methods.
Invention is credited to John A. Faux, Charles Alexander Mosse, Rudolph H. Nobis, Christopher Paul Swain, Omar J. Vakharia.
Application Number | 20060004410 11/127955 |
Document ID | / |
Family ID | 35428803 |
Filed Date | 2006-01-05 |
United States Patent
Application |
20060004410 |
Kind Code |
A1 |
Nobis; Rudolph H. ; et
al. |
January 5, 2006 |
Suture locking and cutting devices and methods
Abstract
Suture holding devices and methods are disclosed, including
devices and methods useful in performing a transoral surgical
procedure, such as a posterior gastropexy procedure. A device is
disclosed which can be used by a physician in a medical procedure
to automatically lock and cut a suture in one motion and without
the need for additional cutting instrumentation, rather than
perform separate locking and cutting actions.
Inventors: |
Nobis; Rudolph H.; (Mason,
OH) ; Vakharia; Omar J.; (Mason, OH) ; Faux;
John A.; (Cincinnati, OH) ; Swain; Christopher
Paul; (London, GB) ; Mosse; Charles Alexander;
(London, GB) |
Correspondence
Address: |
PHILIP S. JOHNSON;JOHNSON & JOHNSON
ONE JOHNSON & JOHNSON PLAZA
NEW BRUNSWICK
NJ
08933-7003
US
|
Family ID: |
35428803 |
Appl. No.: |
11/127955 |
Filed: |
May 12, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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60571117 |
May 14, 2004 |
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60571119 |
May 14, 2004 |
|
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60571000 |
May 14, 2004 |
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Current U.S.
Class: |
606/232 |
Current CPC
Class: |
A61B 2017/0454 20130101;
A61B 2017/0496 20130101; A61B 2017/0464 20130101; A61B 17/0467
20130101; A61B 2017/06052 20130101; A61B 17/0469 20130101; A61B
2017/0417 20130101; A61B 2017/0445 20130101; A61B 17/0487 20130101;
A61B 17/06166 20130101; A61B 2017/045 20130101; A61B 2017/0451
20130101; A61B 2017/0409 20130101; A61B 17/0401 20130101; A61B
2017/0458 20130101; A61B 2017/0488 20130101 |
Class at
Publication: |
606/232 |
International
Class: |
A61B 17/04 20060101
A61B017/04 |
Claims
1. A medical device for locking onto suture comprising: a first
endcap, wherein said first endcap includes a hole bored at an
oblique angle to a central axis; a second endcap; and an extension
spring extending from said first endcap to said second endcap.
2. The medical device of claim 1 wherein first endcap and said
second endcap have an outer diameter of no more than about 0.07
inch.
3. The medical device of claim 1 wherein said hole has a diameter
of about 0.04 inch, and is bored at an angle of about 45 degrees to
the central axis.
4. A medical device for locking onto suture comprising: an endcap;
and an extension spring associated with said endcap, wherein said
spring coils are biased in a compressed state; and a length of
suture held by said spring.
5. The medical device of claim 4 wherein said endcap has an outer
diameter of no more than about 0.07 inch.
6. The medical device of claim 4 wherein the suture is
monofilament.
7. The medical device of claim 4 wherein the suture is braided.
8. A medical device comprising: a first endcap, wherein said endcap
includes a hole bored at an oblique angle to the central axis of
said endcap; a second endcap; a spring disposed intermediate the
first and second endcaps; and a suture extending through said hole
in said first endcap.
9. A method of holding suture comprising the steps of: providing a
first member having a suture receiving hole; providing a second
member associated with the first member, the second member
comprising a plurality of coils; providing a length of suture;
threading a suture through said hole in said first member;
spreading the coils of said second member; and holding the suture
with coils of the second member.
10. The method of claim 7 further comprising the step of: spreading
the coils apart to loosen tension in said suture.
11. A medical device for locking onto suture comprising: a body
portion, wherein said body portion includes at least one suture
channel; a lock sleeve positioned over an outer surface of said
body portion; wherein said lock sleeve has an inner surface that
closely matches the outer surface of said body portion; and a means
for locking said body portion within said lock sleeve.
12. The medical device of claim 11, wherein said locking means
comprises a groove in said body portion and a ring projection in
said locking sleeve.
13. The medical device of claim 11, wherein there is a clearance of
about 0.001 inch or less between the outer surface of said body
portion and the inner surface of said locking sleeve.
14. A method of using a medical device to lock onto suture
comprising the steps: providing a device comprising a body portion,
wherein said body portion includes at least one suture channel; a
lock sleeve positioned over an outer surface of said body portion,
wherein said lock sleeve has an inner surface that closely matches
the outer surface of said body portion; and a means for locking
said body portion within said lock sleeve; threading a suture
through said suture channel; pushing said locking sleeve over said
body portion to trap said suture in a tortuous path; and locking
said locking sleeve to said body portion.
15. A medical device for locking onto suture comprising: a tubular
sleeve including an inner channel; a flap disposed within said
inner channel of said tubular sleeve; and a detent, wherein said
detent is positioned within said inner channel such that said flap
is biased to press against said detent.
16. A medical device for locking onto suture comprising: A first
gripping surface including a plurality of projections; a second
gripping surface, wherein said second grip surface is not in
contact with said first grip surface in a default state; and a
clasp, wherein said clasp holds said first gripping surface against
said second gripping surface in a locked state.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to and incorporates by
reference the following applications: U.S. Provisional Application
60/571,117 filed May 14, 2004; U.S. provisional Application
60/571,119 filed May 14, 2004; and U.S. Provisional Application
60/571,000 filed May 14, 2004.
FIELD OF THE INVENTION
[0002] This invention relates to endoscopic suturing devices and
methods, including devices and methods which may pass through or be
employed in connection with the working channel of various
endoscopic and ultrasound devices.
BACKGROUND
[0003] Application of sutures in the gastrointestinal tract is
required for several different types of medical procedures, for
example, for transoral endoscopic valvuloplasty for
gastroesophageal reflux disease (GERD), gastroplasty,
fundoplication, anterior gastropexy, posterior gastropexy, suturing
esophageal perforations, or closure of the esophageal side of the
tracheo-esophageal fistula. Traditionally, these procedures are
performed by physicians, such as gastroenterologists or surgeons,
either by laparoscopy or open surgical techniques. Such procedures
are invasive, as laparoscopy requires that small access incision(s)
be made in the body of the patient, through which a laparoscope and
other surgical enabling tools are provided, while open surgical
techniques are traditionally invasive and can have complications
and cause long patient recovery periods.
[0004] The solution to these problems is to perform these medical
procedures through the gastroesophageal tract via the mouth or
other naturally occurring orifice. Already available flexible
endoscopes, commonly called gastroscopes, can be provided through
the gastroesophageal tract and enable illumination and
visualization of tissue along the gastroesophageal tract on a video
display for diagnostic purposes. These flexible endoscopes also
provide an instrumentation means for applying sutures in tissue,
such as in the wall of the stomach. What is needed are improved
methods of providing a totally transoral surgical procedure, such
as a posterior gastropexy procedure, and thereby avoid more
invasive laparoscopic procedures.
[0005] New endoscopic suturing methods performed through the
gastroesophageal tract as an alternative to the invasive
laparoscopic method of, for example, a posterior gastropexy
procedure, are currently being developed. For example, suturing
methods under the control of endoscopic ultrasound (EUS) are being
evaluated. EUS is a procedure that combines endoscopy and
ultrasound. In particular, a Mar. 14, 2003 publication authored by
Fritscher-Ravens, Mosse, Mukherjee, Yazaki, Park, Mills, and Swain,
entitled, "Transgastric gastropexy and hiatal hernia repair for
GERD under EUS control: a porcine model," (American Society for
Gastrointestinal Endoscopy) describes how endoluminal operations
for gastroesophageal reflux are currently limited by the inability
of the surgeon to visualize and manipulate structures outside the
wall of the gut. The publication describes a way to define the EUS
anatomy of structures outside the gut that influence reflux, to
place stitches in the median arcuate ligament, to perform posterior
gastropexy, and to test the feasibility of crural repair, under EUS
control, in pigs. More specifically, by using a linear-array EUS,
the median arcuate ligament and part of the right crus were
identified and punctured with a needle, which served as a carrier
for a tag and suture. These were anchored into the muscle. An
endoscopic sewing device was used, which allowed stitches to be
placed through a 2.8-mm accessory channel to any predetermined
depth.
[0006] The publication also describes new methods of knot tying and
suture cutting through the 2.8-mm channel of the EUS. More
specifically, stitches were placed through the gastric wall into
the median arcuate ligament, and one stitch was placed just beyond
the wall of the lower esophageal sphincter. The stitches were tied
together and locked against the gastric wall, and the surplus
length of suture material was then cut and removed. While this
publication describes a suitable transgastric gastropexy and hiatal
hernia repair procedure, further improvements in methodology and
equipment to perform such procedures would be beneficial. For
example, the publication describes a process for locking and
cutting the suture from inside the stomach. However, the suture
requires that a separate suture cutting step, along with its
associated cutting instrumentation, be available via the working
channel of the endoscope. This may result in multiple passes of
instrumentation back and forth through the working channel of the
endoscope. What is needed is a way to both lock and cut a suture
automatically with a single device and thereby simplify the medical
procedure, such as a posterior gastropexy procedure.
[0007] Additionally, the locking mechanism described in the
publication is too large to pass through the working channel of an
endoscope and, thus, it must be inserted into the patient
separately from the endoscope, which again adds complexity to the
medical procedure. What is needed are suture locking and cutting
mechanisms that are small enough to pass through the working
channel of various endoscopic and ultrasound devices (typical
working channel diameter is 2.8-3.4 mm).
SUMMARY OF THE INVENTION
[0008] Applicants recognize the desirability of providing improved
methods of performing a totally transoral surgical procedure, such
as a posterior gastropexy procedure, and thereby avoid
more-invasive laparoscopic procedures. Applicants also recognize
the desirability of providing a single mechanism for automatically
locking and cutting a suture and thereby simplifying medical
procedures, such as, but not limited to, a posterior gastropexy
procedure; and the desirability of providing suture locking and
cutting mechanisms that are small enough to pass through the
working channel of various endoscopic and ultrasound devices.
[0009] Certain embodiments of the present invention are directed to
providing improved methods of performing a totally transoral
surgical procedure, such as a posterior gastropexy procedure, and
thereby avoiding more-invasive laparoscopic procedures. One
embodiment of the present invention provides a device and method
that allows a physician in a medical procedure to automatically
lock and cut a suture in one motion and without the need for
additional cutting instrumentation, rather than perform separate
locking and cutting actions.
[0010] In one embodiment of the invention, a suture lock assembly
in combination with a lock actuating device is provided. The lock
comprises an extension spring arranged between two endcaps, wherein
one or more sutures are locked within the coils thereof. Extending
the extension spring allows for one or more sutures to be threaded
therethrough and, by relaxing the extension spring, provides a
clamping action upon the sutures and a torturous path within the
coils. The lock actuating device provides a cutting mechanism.
Furthermore, both the suture lock assembly, in combination with a
lock actuating device, are suitably small enough to pass through
the working channel of various endoscopic and ultrasound
devices.
[0011] In another embodiment of the invention, a suture lock
assembly is provided that forms a hollow body, within which a clamp
device is engaged and through which one or more sutures is
threaded. Depending upon the slidable position of the clamp device
within the body, the suture within the clamp device is engaged to
clamp the suture permanently. The suture lock assembly of this
embodiment is likewise suitably small enough to pass through the
working channel of various endoscopic and ultrasound devices.
[0012] The various embodiments of the invention can be employed
with various types of suture, including without limitation
monofilament suture and braided suture.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] While the novel features of the invention are set forth with
particularity in the appended claims, the invention, in all its
embodiments, may be more fully understood with reference to the
following description and accompanying drawings.
[0014] FIG. 1A illustrates a perspective view of a suture lock
assembly in accordance with a first embodiment of the
invention;
[0015] FIG. 1B illustrates a cross-sectional view of the suture
lock assembly in accordance with a first embodiment of the
invention;
[0016] FIG. 2 illustrates a side view of an exemplary lock
actuating device according to the first embodiment;
[0017] FIGS. 3A and 3B illustrate a side view and a top view,
respectively, of the distal end of the lock actuating device with
the suture lock assembly of the first embodiment engaged therein in
the default state;
[0018] FIGS. 4A and 4B illustrate a side view and a top view,
respectively, of the distal end of the lock actuating device with
the suture lock assembly of the first embodiment engaged therein in
the lock state;
[0019] FIGS. 5A and 5B illustrate a side view and a top view,
respectively, of the distal end of the lock actuating device with
the suture lock assembly of the first embodiment engaged therein in
the cut state;
[0020] FIG. 6 illustrates a side view of the suture lock assembly
of the first embodiment engaged therein in the release state;
[0021] FIG. 7 illustrates a flow diagram of an example method of
using the suture lock assembly of the first embodiment in
combination with the lock actuating system;
[0022] FIG. 8 illustrates a perspective view of a suture lock
assembly in accordance with a second embodiment of the
invention.
[0023] FIG. 9 illustrates a cross-sectional view of the suture lock
assembly of the second embodiment in the unlocked state.
[0024] FIG. 10 illustrates a cross-sectional view of the suture
lock assembly of the second embodiment in the locked state.
[0025] FIGS. 11A and 11B illustrate cross section views of an
alternative locking device with a one-way flap inside a tubular
segment, in a loading state, and a locked state, respectively.
[0026] FIGS. 12A and 12B show a cross section view of alternative
one-piece clip in a default state, and a cross section view of the
one-piece clip in a locked state, respectively.
DETAILED DESCRIPTION OF THE INVENTION
[0027] FIG. 1A illustrates a perspective view of a suture lock
assembly 100 in accordance with a first embodiment of the
invention. Suture lock assembly 100 includes an extension spring
112 arranged between a distal endcap 114 and a proximal endcap
116.
[0028] Extension spring 112 is formed of any nontoxic, noncorrosive
metal, such as stainless steel, and distal endcap 114 and proximal
endcap 116 are formed of, for example, molded plastic or stainless
steel. Also shown in FIG. 1 is a suture 118 threaded first through
a hole 120 in distal endcap 114 and then through multiple coils of
extension spring 112, wherein suture 118 is clamped because of the
pressure of the coils and the tortuous path within the coils.
Suture lock assembly 100 is not limited to a single suture 118
installed therein; a plurality of sutures 118 may be engaged within
a single suture lock assembly 100.
[0029] FIG. 1B illustrates a cross-sectional view of suture lock
assembly 100 taken along line AA of FIG. 1A. This view shows that
proximal endcap 116 further includes a hollow channel 121 that runs
through its center. Furthermore, hole 120 in distal endcap 114 is
angled from the center of an outer end of distal endcap 114 toward
the sidewall of distal endcap 114, which thereby allows suture 118
to exit distal endcap 114 external to extension spring 112. Distal
endcap 114 and proximal endcap 116 may be insert-molded onto
extension spring 112 or use other methods or procedures of
providing a smooth, trauma free extension of spring coils.
[0030] In operation, suture 118 is threaded first through hole 120
in distal endcap 114; extension spring 112 is then extended and
suture 118 is threaded through multiple coils of extension spring
112; extension spring 112 is then relaxed, which thereby applies a
tortuous path in addition to a clamping or locking action upon
suture 118 between the coils thereof. The overall diameter of
suture lock assembly 100 is suitably small enough to allow it to
pass through the working channel of various endoscopic and
ultrasound devices, which is typically between 2.8 and 3.4 mm in
diameter. See Table 1 for example dimensions of suture lock
assembly 100. TABLE-US-00001 TABLE 1 Example dimensions of suture
lock assembly 100 Example Dimension Suture lock assembly 100
overall length 0.70 in Extension spring 112 outside diameter 0.060
in Extension spring 112 inside diameter 0.040 in Distal endcap 114
outside diameter 0.07 in Distal endcap 114 length 0.15 in Proximal
endcap 116 outside diameter 0.07 in Proximal endcap 116 length
0.125 in Hollow channel 121 diameter 0.04 in Hole 120 diameter 0.04
in Hole 120 angle 45 degrees
[0031] FIG. 2 illustrates a side view of a lock actuating device
200, which is exemplary only and representative of any suitable
actuating device for use with suture lock assembly 100. In this
example, lock actuating device 200 includes a body 210 that has a
knob 212 arranged at its proximal end for grasping by the user.
Mechanically coupled to body 210 is a retract handle 214, which has
a retract handle body 216 and a retention handle 218 that is
slidably arranged within retract handle body 216. Furthermore, a
compression spring 220 is mechanically coupled between a spring
retainer 222, which is coupled to knob 212, and the proximal end of
retract handle body 216. Mechanically coupled to the distal end of
retract handle body 216 is a hollow retractable sleeve 224, within
which is first arranged a hollow retention sleeve 225, which has a
retention jaw 226 at its distal end. Furthermore, arranged within
retention sleeve 225 is an actuating shaft 228. FIG. 2 also shows
that arranged within the distal end of retractable sleeve 224 is a
first slot 230 that is aligned opposite a second slot 232. Also,
arranged within the distal end of retention sleeve 225 is a hole
234 that is aligned opposite a slot 236.
[0032] Actuating shaft 228 of a fixed length is mechanically
coupled at one end to the distal end of spring retainer 222 while
passing through spring retainer 222. Actuating shaft 228 passes
through a hollow channel within retract handle body 216, then
passes through the hollow channel of retention jaw 226 within
retractable sleeve 224. The tip of actuating shaft 228 extends
through an opening at the distal end of retention jaw 226 within
retractable sleeve 224. Using retract handle 214 and retention
handle 218, retractable sleeve 224 and retention sleeve 225 are
slidable along the length of actuating shaft 228. As a result, the
relative axial position of retractable sleeve 224, retention jaw
226, and actuating shaft 228 may vary one to another under user
control. Lock actuating device 200 may include well-known
mechanical methods and elements (not shown) for holding retractable
sleeve 224 and retention jaw 226 at various positional states.
[0033] The operation of suture lock assembly 100 in combination
with lock actuating device 200 for automatically locking and
cutting a suture includes a sequential transition from a default
state (i.e., undeployed state) to a lock state, a cut state and,
finally, a release state (i.e., deployed state), as described in
reference to FIGS. 3A, 3B, 4A, 4B, 5A, 5B, 6, and 7. Additionally,
FIGS. 3A, 3B, 4A, 4B, 5A, 5B, and 6 show suture lock assembly 100
in use and, therefore, it includes suture 118, which runs through
the center of suture lock assembly 100 and approximates a first
tissue 122 and a second tissue 124. Suture 118 is anchored to
second tissue 124 with a T-tag 126, which is a well-known medical
device for anchoring a suture into body tissue.
[0034] FIGS. 3A and 3B illustrate a side view and a top view,
respectively, of the distal end of lock actuating device 200 with
suture lock assembly 100 engaged therein in the default state,
which is described as follows.
[0035] Default state: In the default or undeployed state, extension
spring 112 is extended suitably to allow suture 118 to slide freely
through its coils. This is accomplished by the physician's passing
actuating shaft 228 through hollow channel 121 of proximal endcap
116, then through the center of extension spring 112, until the tip
of actuating shaft 228 abuts the inner surface of distal endcap
114. By using retention handle 218, which is attached to the
proximal end of retention sleeve 225, the physician extends
retention jaw 226 to allow it to grip proximal endcap 116 and then
pull proximal endcap 116 into the tip of retractable sleeve 224, as
shown in FIGS. 3A and 3B, which thereby extends extension spring
112, relative to the tip of actuating shaft 228. The distance
between the tip of actuating shaft 228 and the tip of retractable
sleeve 224 is predetermined to suitably extend extension spring
112. Additionally, suture 118 is threaded first through hole 120 in
distal endcap 114, then within the extended coils of extension
spring 112 is wrapped multiple times around actuating shaft 228,
through first slot 230 of retractable sleeve 224, through hole 234
of retention sleeve 225, passes around actuating shaft 228, through
slot 236 of retention sleeve 225 and, finally, through second slot
232 of retractable sleeve 224.
[0036] FIGS. 4A and 4B illustrate a side view and a top view,
respectively, of the distal end of lock actuating device 200 with
suture lock assembly 100 engaged therein in the lock state, which
is described as follows.
[0037] Lock state: In the lock state, extension spring 112 is
relaxed, which allows its coils to clamp against suture 118 and
thereby prevent suture 118 from sliding freely between the coils of
extension spring 112. By using retention handle 218, which is
attached to the proximal end of retention sleeve 225, the physician
extends retention jaw 226 while gripping proximal endcap 116 in a
direction toward distal endcap 114 and while maintaining the
relative distance between the tip of actuating shaft 228 and the
tip of retractable sleeve 224, as set in the default state.
Although the relative position of hole 234 and slot 236 to first
slot 230 and second slot 232, respectively, is changed, suture 118
is intact and passing freely through first slot 230 of retractable
sleeve 224, through hole 234 of retention sleeve 225, passes around
actuating shaft 228, through slot 236 of retention sleeve 225, and
through second slot 232 of retractable sleeve 224, as shown in
FIGS. 4A and 4B.
[0038] FIGS. 5A and 5B illustrate a side view and a top view,
respectively, of the distal end of lock actuating device 200 with
suture lock assembly 100 engaged therein in the cut state, which is
described as follows.
[0039] Cut state: In the cut state, the relative distance between
the tip of actuating shaft 228 and the tip of retention jaw 226 is
maintained, as set in the lock state. By using retract handle 214,
which is attached to the proximal end of retractable sleeve 224,
the physician retracts tip of retractable sleeve 224 in a direction
away from the tip of retention jaw 226, which causes the position
of hole 234 and slot 236 within retention sleeve 225 to change,
relative to first slot 230 and second slot 232, respectively, such
that suture 118 within hole 234 is cut as hole 234 passes
underneath the edge of first slot 230, which has a ground edge
suitable for cutting suture 118.
[0040] FIG. 6 illustrates a side view of suture lock assembly 100
in the release state, which is described as follows.
[0041] Release state: In the release state, the physician
manipulates the grasp of retention jaw 226 and proximal endcap 116
is released, which allows all instrumentation, such as lock
actuating device 200 and the endoscope, as well as the surplus
length of suture 118, to be removed. Extension spring 112 remains
relaxed and, thus, the locking action upon suture 118 is maintained
indefinitely within the patient.
[0042] In an alternative embodiment, rather than wrapping the
suture 118 multiple times around shaft 228 within the extended
coils of spring 112, the suture 118 can be manually threaded
through or otherwise positioned between the extended coils, such as
in a serpentine fashion, so that the coils hold the suture when the
coils are permitted to close together. Such manual positioning of
the suture through the coils may be employed if the shaft 228 is
not employed or is otherwise not positioned within the spring 112
when the suture is positioned with respect to the coils of spring
112.
[0043] FIG. 7 illustrates a flow diagram of an example method 700
of using suture lock assembly 100 in combination with lock
actuating device 200 in accordance with the invention. More
specifically, method 700 provides an example of a posterior
gastropexy procedure that uses suture lock assembly 100 of the
present invention. The use of suture lock assembly 100 is not
limited to a posterior gastropexy procedure; suture lock assembly
100 may be used in any of various, similar medical procedures.
Furthermore, method 700 is not limited to a single suture 118
installed within suture lock assembly 100; a plurality of sutures
118 may be engaged within a single suture lock assembly 100.
[0044] At step 710, a physician passes an EUS endoscope through a
patient's mouth and esophagus and into the stomach. Example EUS
endoscopes include endoscope model GF-UC160P-AT8 manufactured by
Olympus Europe (Hamburg, Germany) and endoscope model EG-3630U
manufactured by Pentax Medical Company (Orangeburg, N.Y.). The
working channel of the EUS endoscope is preloaded with a standard
EUS needle, such as is manufactured by Wilson-Cook (Winston-Salem,
N.C.), that serves as a carrier for a tag and suture, such as T-tag
126 and suture 118. Suture 118 may run either through the needle or
outside the needle, but still inside the working channel of the EUS
endoscope.
[0045] At step 712, under the guidance of the EUS endoscope, the
physician locates and identifies structures outside the stomach
wall and selects a fixation point, such as the median arcuate
ligament.
[0046] At step 714, under the guidance of the EUS endoscope, the
physician pushes the EUS needle, which is carrying T-tag 126 and
suture 118, through the stomach wall, which is represented by first
tissue 122 in FIGS. 3A, 3B, 4A, 4B, 5A, 5B, and 6.
[0047] At step 716, under the guidance of the EUS endoscope, the
physician deploys and affixes T-tag 126, with suture 118 attached
thereto, to the fixation point, such as to the median arcuate
ligament, which is represented by second tissue 124 in FIGS. 3A,
3B, 4A, 4B, 5A, 5B, and 6.
[0048] At step 718, the physician withdraws the EUS endoscope and
associated instrumentation from the patient, but leaves a length of
suture 118 still threaded through the patient's gastroesophageal
tract and anchored to second tissue 124 (e.g., median arcuate
ligament). The length of suture 118 extends out of the patient's
mouth and is accessible to the physician.
[0049] At step 720, the physician threads the length of suture 118
that is extending out of the patient's mouth into the distal end
and out of the proximal end of the working channel of a standard
endoscope that has a standard vision system (i.e., not an EUS
endoscope).
[0050] At step 722, while holding tension on suture 118, the
physician passes the endoscope through the patient's mouth and
esophagus and into the stomach. A length of suture 118 is left
extending out of the proximal end of the working channel of the
endoscope and is accessible to the physician.
[0051] At step 724, the physician loads suture lock assembly 100
into the distal end of lock actuating device 200 and sets suture
lock assembly 100 into the default state, as described in reference
to FIGS. 3A and 3B.
[0052] At step 726, with suture lock assembly 100 in the default
state and loaded into lock actuating device 200, the physician
first threads the length of suture 118 that is extending out of the
proximal end of the endoscope through hole 120 in distal endcap
114, then within the extended coils of extension spring 112 is
wrapped multiple times around actuating shaft 228, then threaded
through hole 234 of retention sleeve 225, then threaded through
first slot 230 of retractable sleeve 224, then threaded through
second slot 236 of retention sleeve 225 and, finally, threaded
through second slot 232 of retractable sleeve 224, as shown in
FIGS. 3A and 3B.
[0053] At step 728, while holding tension on suture 118, which is
extending out of second slot 232 of retractable sleeve 224, the
physician passes the suture lock assembly 100 and retractable
sleeve 224 of lock actuating device 200 through the working channel
of the endoscope and into the patient's stomach. Suture lock
assembly 100 is sliding freely along suture 118 in the default
state, until distal endcap 114 is firmly abutted against the inside
of the stomach wall, which is represented by first tissue 122 in
FIGS. 3A, 3B, 4A, 4B, 5A, 5B, and 6.
[0054] At step 730, having determined that the desired geometry
change between the stomach and the median arcuate ligament
(represented by first tissue 122 and second tissue 124) is achieved
and while continuing to hold tension on suture 118, the physician
sets suture lock assembly 100 into the lock state by using
retention handle 218, as described in reference to FIGS. 4A and 4B,
which causes the coils of extension spring 112 to relax and create
a torturous path and, thus, clamp against suture 118, as shown in
FIGS. 4A and 4B.
[0055] At step 732, having secured suture lock assembly 100 against
first tissue 122 with suture 118, the physician sets suture lock
assembly 100 into the cut state by using retract handle 214, as
described in reference to Figures SA and 5B, which causes suture
118 to be cut as hole 234 passes underneath the edge of first slot
230, which has a geometry suitable for cutting suture 118, as shown
in FIGS. 5A and 5B.
[0056] At step 734, having secured suture lock assembly 100 against
first tissue 122 and having cut suture 118, the physician releases
retention jaw 226 from proximal endcap 116 of suture lock assembly
100, which allows all instrumentation, such as lock actuating
device 200 and the endoscope, and the surplus length of suture 118,
to be withdrawn from the patient, while suture 118 remains firmly
clamped, as shown in FIG. 6. Method 700 ends.
[0057] FIG. 8 illustrates a perspective view of a suture lock
assembly 800 in accordance with a second embodiment of the
invention. Suture lock assembly 800 includes a cylindrical-shaped
lock body 810 that further includes a plurality of suture channels
812 that run therethrough, and which have an associated plurality
of locking holes 814 arranged on the outer surface of lock body
810. Suture lock assembly 800 further includes a lock sleeve 816
that further includes a cavity 818 (shown in FIGS. 9 and 10) within
which lock body 810 is inserted. Lock body 810 further includes a
first groove 824 and a second groove 826, which are detents formed
around the outer perimeter of lock body 810. Lock sleeve 816
further includes a first locking ring 820 and a second locking ring
822, which are raised regions protruding from the inside perimeter
of cavity 818 that are sized to lock within the detents formed by
first groove 824 and second groove 826 of lock body 810.
[0058] Also shown in FIG. 8 is suture 118, which is anchored to
second tissue 124 with T-tag 126 passes through first tissue 122
and into one of the suture channels 812, and exits lock body 810
via one of associated locking holes 814. Only a small portion of
the distal end of lock body 810 is inserted into cavity 818, such
that locking holes 814 are not within cavity 818 of lock sleeve
816. Lock body 810 and lock sleeve 816 are formed of, for example,
molded plastic or stainless steel.
[0059] FIG. 9 illustrates a cross-sectional view of a suture lock
assembly 800 and shows suture 118 passing through one of the suture
channels 812 and existing lock body 810. FIGS. 8 and 9 are
representative of suture lock assembly 800 in the default, unlocked
state wherein one or more sutures 118 may be threaded freely
through lock body 810. In the default or unlocked state first
locking ring 820 of lock sleeve 816 is engaged within second groove
826 of lock body 810, as shown in FIGS. 8 and 9.
[0060] FIG. 10 illustrates a cross-sectional view of a suture lock
assembly 800 in a locked state wherein or more sutures 118 is
threaded through lock body 810 and locked therein. More
specifically, in the lock state, lock sleeve 816 is pushed over the
entire length of lock body 810, such that suture 118 is clamped
between the outer surface of lock body 810 and the wall of cavity
818 of lock sleeve 816, after which any surplus suture 118 material
is cut, which leaves suture lock assembly 800 secured against first
tissue 122. In order to achieve the locked state enough force is
applied to lock sleeve 816 against lock body 810 such that first
locking ring 820 of lock sleeve 816 disengages from within second
groove 826 of lock body 810. In doing so, lock sleeve 816 slides
upon lock body 810 until first locking ring 820 and second locking
ring 822 are engaged within first groove 824 and second groove 826,
respectively, of lock body 810, as shown in FIG. 10. The mechanical
features of suture lock assembly 800 for coupling lock sleeve 816
to lock body 810 are exemplary only and are not limited to first
locking ring 820, second locking ring 822, first groove 824, and
second groove 826. Any well-known coupling method that allows a
default and lock state by sliding lock sleeve 816 upon lock body
810 may be used.
[0061] The overall diameter of suture lock assembly 800 is suitably
small enough to allow it to pass through the working channel of
various endoscopic and ultrasound devices, which is typically
between 2.8 and 3.4 mm in diameter. See Table 2 for example
dimensions of suture lock assembly 800. TABLE-US-00002 TABLE 2
Example dimensions of suture lock assembly 800 Example Dimension
Lock body 810 length 0.35 in Lock body 810 outside diameter 0.07 in
Suture channels 812 diameter 0.015 in Lock sleeve 816 length 0.38
in Lock sleeve 816 inside diameter 0.07 in Suture lock assembly 800
overall length 0.39 in when locked
[0062] The method of using suture lock assembly 800, in combination
with suture 118, T-tag 126, first tissue 122, and second tissue
124, is generally the same as described in FIG. 7, in reference to
suture lock assembly 100, in that it is fed down the working
channel of an endoscope and into, for example, a patient's stomach,
in much the same manner. However, suture lock assembly 800 requires
no special actuating device; instead, it may be pushed through the
working channel of an endoscope with, for example, the tip of a
standard catheter. Additionally, its use differs from suture lock
assembly 100, in that suture lock assembly 800 requires separate
instrumentation for cutting the one or more sutures 118 engaged
therein.
[0063] FIGS. 11A and 11B illustrate an alternative locking device
similar in function to those previously mentioned. The locking
device of FIGS. 11A and 11B are designed to lock onto suture 118,
when used in conjunction with the endoscope. The locking device of
FIGS. 11A and 11B may be placed on suture 118 attached to T-tag
126, that has been placed through first tissue 122 and second
tissue 124 using the previously-described technique.
[0064] This embodiment comprises a tubular sleeve 1100, a flap
1105, and a detent 1120. Tubular sleeve 1100 may have an outer
diameter of about 2.6 mm and an inner diameter of about 1 mm, and
may be injection molded from a suitable polymer, such as
polycarbonate, as a single piece or as separate pieces which are
then fused together to form a unitary structure. In a resting
state, flap 1105 is biased toward contact with detent 1120.
Therefore, to load suture 118 into tubular segment 1100, an
introducer 1130 may be used to create space between flap 1105 and
detent 1120 as shown in FIG. 11A. Introducer 1130 may be placed
into tubular segment 1100 by pushing from a distal end 1122 of
tubular segment 1100, so that flap is moved away from detent 1120.
Suture may be placed through a central lumen 1135 of introducer
1130, so that ultimately suture 118 is positioned within tubular
segment 1100. Introducer 1130 is then removed by pulling it out of
tubular segment 1100 from a proximal end 1133, so that introducer
1130 is not trapped between tubular segment 1100 and second tissue
124.
[0065] After introducer 1130 is removed, tubular segment 110 may be
pushed along suture 118 toward second tissue 124 with a pusher 1140
especially designed for that purpose, as shown in FIG. 11B. Tension
on suture 118 acts to pull flap 1105 partially away from detent
1120 during advancement. When distal end 1122 of tubular segment
1100 reaches second tissue 124, pusher 1140 is withdrawn and flap
1105 traps suture 118 against detent 1120 so that tubular segment
1100 is held securely in place.
[0066] FIGS. 12A and 12B show another alternative concept for
locking onto suture 118. FIG. 12A shows a perspective view of a
clip 1200 comprising a first gripping surface 1210, a second
gripping surface 1220, an opening 1230, and a clasp 1240. In a
default state, clip 1200 is open as shown in FIG. 12A, so that
suture 118 can pass freely through opening 1230. Clip 1200 may be
placed on suture 118 attached to T-tag 126, that has been placed
through first tissue 122 and second tissue 124 using the
previously-described technique. Clip 1200 may be placed onto suture
118 so that clasp 1280 is directed toward second tissue 124 and
opening 1230 is directed toward the user. Clip 1200 may be pushed
down suture 118 using a long flexible tube, such as an
endoscope.
[0067] To lock clip 1200 onto suture 118, a horn 1270 including a
tapered surface 1272 may be used to apply force at a proximal end
of clip 1200, so that first gripping surface 1210 mates with second
gripping surface 1220 to securely hold onto suture 118, while clasp
1280 holds clip 1200 closed. Clip 1200 may be made from any
suitable polymer material, such as nylon. Clip 1200 may be
injection molded as a unitary piece with a "living hinge" that
biases the part to an open position in which a first gripping
surface 1210 is held away from second gripping surface 1220 in a
default open state or assembled from multiple pieces.
[0068] While the present invention has been illustrated by
description of various embodiments, it is not the intention of the
applicants to restrict or limit the spirit and scope of the
appended claims to such detail. Numerous other variations, changes,
and substitutions will occur to those skilled in the art without
departing from the scope of the invention. Moreover, the structure
of each element associated with the present invention can be
alternatively described as a means for providing the function
performed by the element. It will be understood that the foregoing
description is provided by way of example, and that other
modifications may occur to those skilled in the art without
departing from the scope and spirit of the appended Claims.
* * * * *