U.S. patent application number 15/165425 was filed with the patent office on 2016-09-22 for tissue-acquisition and fastening devices and methods.
This patent application is currently assigned to Boston Scientific Scimed, Inc.. The applicant listed for this patent is Boston Scientific Scimed, Inc.. Invention is credited to Daniel BALBIERZ, David COLE, Samuel T. CREWS, Justen ENGLAND, Pablo R. HAMBLY, Craig Arthur PURDY, Bretton SWOPE.
Application Number | 20160270785 15/165425 |
Document ID | / |
Family ID | 44121349 |
Filed Date | 2016-09-22 |
United States Patent
Application |
20160270785 |
Kind Code |
A1 |
BALBIERZ; Daniel ; et
al. |
September 22, 2016 |
TISSUE-ACQUISITION AND FASTENING DEVICES AND METHODS
Abstract
Devices and methods for acquiring and fastening tissues folds
within an internal organ, such as the stomach, and for applying the
methods and devices to producing reductions in organ volume or
repair of bariatric procedures, are disclosed. An exemplary method
for forming a continuous laterally extending tissue fold involves
forming a succession of laterally extending folds having adjacent
overlapping fold portions. One exemplary tissue-acquisition device
has an open-end roller-and-arm structure that allows individual
tissue folds to be formed and fastened, then advanced to an
adjacent region within the stomach, for capture of a new fold that
will form an extension of the existing fold(s).
Inventors: |
BALBIERZ; Daniel; (Redwood
City, CA) ; COLE; David; (Weybridge, VT) ;
SWOPE; Bretton; (Gaithersburg, MD) ; HAMBLY; Pablo
R.; (San Mateo, CA) ; ENGLAND; Justen; (San
Francisco, CA) ; CREWS; Samuel T.; (Palomar Park,
CA) ; PURDY; Craig Arthur; (Campbell, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Boston Scientific Scimed, Inc. |
Maple Grove |
MN |
US |
|
|
Assignee: |
Boston Scientific Scimed,
Inc.
|
Family ID: |
44121349 |
Appl. No.: |
15/165425 |
Filed: |
May 26, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
13112664 |
May 20, 2011 |
|
|
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15165425 |
|
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61347345 |
May 21, 2010 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 17/0684 20130101;
A61B 17/072 20130101; A61B 2017/07214 20130101; A61B 2017/081
20130101; A61B 17/0686 20130101; A61B 2017/306 20130101; A61F
5/0086 20130101; A61B 17/0643 20130101; A61B 2017/00818 20130101;
A61B 17/0644 20130101; A61B 2017/2926 20130101; A61B 17/07207
20130101; A61B 17/0682 20130101 |
International
Class: |
A61B 17/072 20060101
A61B017/072; A61B 17/064 20060101 A61B017/064 |
Claims
1-30. (canceled)
31. A method for delivering a fastener to tissue of a patient,
comprising: positioning a distal end of an elongate arm adjacent to
the tissue, wherein the elongate arm includes an internal channel
and a fastener positioned within the internal channel, and wherein
an outer surface of the elongate arm tapers radially inward in a
proximal-to-distal direction, and wherein positioning includes
positioning the outer surface against the tissue so that the
internal channel of the elongate arm forms an acute angle with the
tissue; and deploying the fastener from the internal channel to
cause the fastener to secure two tissue layers together.
32. The method of claim 31, wherein the fastener includes at least
one leg that is preformed to adopt a loop shape after
deployment.
33. The method of claim 31, wherein the elongate arm includes a
plurality of fasteners positioned within the internal channel.
34. The method of claim 33, wherein the method includes deploying
each of the plurality of fasteners from the internal channel.
35. The method of claim 31, wherein the fastener includes a base
and a pair of elongate legs extending from the base, and when
positioned in the internal channel, the base is positioned
proximally to the legs.
36. The method of claim 31, wherein the tissue is stomach tissue of
the patient.
37. The method of claim 31, wherein the internal channel includes a
trapezoidal cross-sectional shape.
38. The method of claim 31, wherein the fastener includes
nitinol.
39. A method for delivering a fastener to tissue of a patient,
comprising: positioning a distal end of an elongate arm adjacent to
the tissue so that an internal channel of the elongate arm forms an
acute angle with the tissue, wherein the elongate arm includes a
plurality of fasteners positioned within the internal channel; and
deploying each of the plurality of fasteners to cause each fastener
to secure two tissue layers together, forming a continuous tissue
fold.
40. The method of claim 39, wherein an outer surface of the
elongate arm tapers radially inward in a proximal-to-distal
direction, and wherein positioning includes positioning the outer
surface against the tissue.
41. The method of claim 39, wherein each fastener includes a base
and a pair of elongate legs extending from the base.
42. The method of claim 41, wherein each elongate leg of each
fastener is preformed to adopt a loop shape after deployment, and
after deployment, each loop extends fully through a first layer of
the two tissue layers and at least partially through a second layer
of the two tissue layers.
43. The method of claim 39, wherein each of the plurality of
fasteners is deployed using a pusher against a proximal end of a
proximal-most fastener of the plurality of fasteners.
44. The method of claim 39, wherein the plurality of fasteners are
arranged inline while in the internal channel of the elongate
arm.
45. The method of claim 39, wherein at least one fastener of the
plurality of fasteners includes only a single elongate leg, and the
single elongate leg is preformed to adopt a loop shape.
46. A method for delivering a fastener to tissue of a patient,
comprising: positioning a distal end of an elongate arm adjacent to
tissue, wherein the elongate arm includes an internal channel and a
plurality of fasteners positioned within the internal channel, and
wherein an outer surface of the elongate arm tapers radially inward
in a proximal-to-distal direction, and wherein positioning includes
positioning the outer surface against the tissue so that the
internal channel of the elongate arm forms an acute angle with the
tissue; and deploying each of the plurality of fasteners to cause
each fastener to secure two tissue layers together, forming a
continuous tissue fold; wherein each fastener includes at least one
leg that is preformed to adopt a loop shape after deployment.
47. The method of claim 46, wherein each fastener includes a pair
of legs that are preformed to adopt a loop shape after
deployment.
48. The method of claim 46, wherein the tissue fold is comprised of
stomach tissue of the patient.
49. The method of claim 46, wherein the at least one leg of each
fastener includes nitinol.
50. The method of claim 46, wherein the loop shape has a diameter
between 60-120 mils.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application claims priority to U.S. Provisional
Application Serial No. 61/347,345 filed May 21, 2010, which is
herein incorporated by reference in its entirety.
FIELD OF THE INVENTION
[0002] The present invention relates to devices and methods for
acquiring and fastening tissues folds within an internal organ,
such as the stomach, and for applying the devices and methods to
producing reductions in organ volume or repair of bariatric
procedures.
BACKGROUND OF THE INVENTION
[0003] Numerous surgical procedures are performed to treat the
chronic disease of obesity. Common surgical procedures include Roux
en Y gastric bypass, Sleeve Gastrectomy, Gastric Banding and
Biliopancreatic Diversion with or without duodenal switch. Each of
these are effective in the treatment of obesity, but carry inherent
risks associated with surgery, stapling and transection of the
stomach, and pain and potential infection(s) associated with post
operative recovery due to the skin incisions. Additionally, access
to the patient's stomach is difficult in obese patients, further
complicating the surgery.
[0004] A relatively new surgical procedure has been performed which
does not require stapling or transection of the stomach. In this
procedure the stomach is exposed, and the greater curvature of the
stomach is first freed from any connective tissue or vasculature.
The greater curvature of the stomach is then rolled in on itself
(Inverted) and sewn together using suture or clips. This process is
continued until sufficient folds of tissue have been inverted to
produce a reduction in stomach size and also a reduction in the
motility of the stomach. The procedure itself is time consuming due
to the difficult access, the need to cut away connecting tissue,
and the required hand stitching/clipping of the folds, and the
patient is subjected to all of the risks of other surgical
procedures.
[0005] The invention herein reduces these problems by performing a
stomach-volume reduction procedure in a completely transoral
method, requiring no incisions to reach the site of operation. In
this method, a tissue-acquisition device is inserted down the
throat and unlike the prior art, large volumes of tissue are able
to be acquired and fastened, aligning serosa to serosa. Since the
procedure is done transorally, no freeing of connective tissue on
the exterior of the stomach is performed. And rather than inverting
the greater curvature, plications (inversion of tissue) are
performed on the anterior and/or posterior walls and/or fundus to
reduce stomach size and motility. These serosal layers are then
secured using standard staples, clips, fasteners, or the like.
[0006] Methods for carrying out various stomach plication or
remodeling procedures transorally are known in the art. U.S. Pat.
Nos. 7,204,842, 7,153,314, 6,926,722, 5,887,594, 5,676,674,
5,403,326, and for example, disclose methods and devices for
creating folds at or near the gastro-esophageal junction, in the
treating of gastroesophageal reflux disease (GERD). U.S. Pat. Nos.
7,175,638, 6,835,200, 6,821,285, 6,494,888, 6,558,400 and 6,086,600
disclose tissue plication methods and device for capturing and
fastening individual serosal-to-serosa tissue plications within an
internal organ, such as the stomach. U.S. Pat. Nos. 7,288,101,
7,097,650, 7,083,692, 7,306,614, 6,773,441, and 6,663,639 disclose
methods and devices for remodeling the stomach by drawing together
and fastening a pair of individual tissue plications formed in
remote regions of the stomach. However, none of the above
references discloses forming elongate, extended serosal-to-serosa
tissue folds in the stomach, in the treatment of obesity-related
eating disorders, or devices that are designed for efficiently
forming such extended folds.
SUMMARY OF THE INVENTION
A. Method of Forming a Continuous, Extended Two-Layer Tissue
Fold
[0007] The present invention includes, in one aspect, a method of
treating an obesity-related eating disorder in a patient, by the
steps of: (a) intraorally placing within the patient's stomach, a
tissue-acquisition device capable of acquiring and fastening a
laterally extending two-layer tissue fold; (b) placing the
tissue-acquisition device against a selected region of the interior
of the stomach's anterior wall, posterior wall, or fundus; (c)
operating the device to acquire and fasten a laterally extending
two-layer tissue fold; (d) moving the tissue-acquisition to place
it against a new selected interior stomach region adjacent the
fastened tissue fold formed in step (c), such that the device, when
operated to acquire a tissue fold, will form a single laterally
extending tissue fold that includes the fold formed in step (c) and
which extends along a region of the stomach's anterior wall, or
posterior wall, or fundus; and (e) repeating steps (c) and (d)
until an elongate, continuous two-layer tissue fold composed of at
least three individually-fastened folds formed in steps (c) is
formed in the stomach's anterior wall, posterior wall, or
fundus.
[0008] Step (e) of the method may be carried out until the total
volume of the stomach interior has been reduced by at least 40%,
and/or until a length of tissue fold effective to substantially
reduce stomach motility, as evidenced by a reduction in measured
periodic motor activity after eating, is created.
[0009] In one embodiment, the tissue-acquisition device used to
acquire and fasten tissue in step (c) includes an open-end roller
device having a roller, a roller-confronting arm, and a clamping
mechanism activatable to move the arm between open and closed
conditions; where step (c) includes rotating the roller in a
direction effective to draw a tissue fold between the roller and
arm, and step (d) includes activating the clamping mechanism to its
open and closed positions, respectively, before and after moving
the device to a position in which the open end of the device
embraces a region of a previously acquired and fastened tissue
fold. The roller in the device may have a plurality of elongate
tissue-capture chambers distributed radially about the roller, such
that applying a vacuum to the roller while rotating the roller in
the tissue-advancing direction functions to draw a tissue fold
between the roller and arm by successive capture and release of
tissue in successive tissue-capture chambers. The device may
further include a pusher operable to eject a fastener through a
tissue fold formed between the roller and arm of the device; and
step (c) includes activating the pusher to place a fastener between
the layers of a tissue fold.
[0010] In another embodiment, the tissue-acquisition device used to
acquire and fasten tissue includes an auger-blade
tissue-acquisition device having (i) a frame, (ii) a pair of
interleaved, helical-surface augur blades that are mounted on the
frame for rotation about substantially parallel axes and for
movement toward and away from one another under a force that biases
the two blades toward one another, and (iii) a drive mechanism for
rotating at least one of the two blades in a selected
direction.
[0011] In a third embodiment of the method, the tissue-acquisition
device used to acquire and fasten tissue in step (c) includes a
scissor-arm cage covered by a flexible membrane that is open at one
side of the cage only; the cage is expandable from a collapsed
condition for step (a) to an expanded condition operable to draw a
two-layer tissue fold into the cage, when the cage's open side is
placed against a selected stomach region in steps (b) or (d), and a
vacuum is applied to the interior of the cage in step (c).
[0012] In each of these embodiments, the tissue-acquisition device
may have a fastener mechanism for fastening tissue folds integrated
into the device, or a fastening mechanism that operates
independently of the structure used in for tissue acquisition.
Suitable fastener mechanisms that can either be integrated into a
tissue-acquisition device or operated independently are described
below in Sections G-J.
B. Method of Restoring a Vertical Sleeve Gastrectomy
[0013] In a related aspect, the invention includes a method of
restoring a vertical sleeve gastrectomy (VSG) procedure that has
failed in a patient because the patient's stomach has expanded and
regained a significant portion of its pre-surgical volume, by
incorporating the vertical stomach seam formed in the initial VSG
operation into an elongate fold in the stomach, by the steps of:
(a) intraorally placing within the patient's stomach, a
tissue-acquisition device capable of acquiring a two-layer tissue
fold by vacuum and fastening the fold to form a plication; (b)
placing the tissue-acquisition device against a region of the
stomach adjacent the seam formed during the vertical sleeve
gastrectomy; (c) operating the device to acquire and fasten a
two-layer tissue fold that contains a section of the VSG seam, (d)
moving the tissue-acquisition to place it against a new selected
interior stomach region adjacent the fastened tissue fold formed in
step (c), and (e) repeating steps (c) and (d) until the VSG volume
of the stomach has been restored.
[0014] Any of the devices described in Sections C-F below may be
used in practicing the method. In a preferred embodiment, the
method is carried out, as in Section A, to form a single
continuous, extended plication that incorporates the VSG seam,
employing one of the tissue-acquisition device described in Section
C-E.
C. Roller-Arm Tissue-Acquisition Device and Method
[0015] The invention further includes a roller-arm
tissue-acquisition device for acquiring a tissue fold. The device
has (i) a support frame, (ii) an elongate roller mounted on the
frame for rotation about the roller's long axis, where the roller
includes tissue-engaging structure for engaging tissue and
advancing the engaged tissue in the direction of roller rotation;
(iii) a roller driver for rotating the roller in a tissue-advancing
direction; (iv) an arm mounted on said frame at a position spaced
from and confronting the roller, between which a two-layer tissue
fold is formed, as tissue is advanced into and through the device
as the roller is rotated; and (v) a vacuum conduit in the frame for
connecting an external vacuum source to said roller or to the arm,
to hold one layer of a two-layer tissue fold by vacuum adherence,
as tissue is being advanced into and through the device by rotation
of the roller.
[0016] For use in forming a tissue fold in within the interior of
the gastrointestinal tract, the device further includes an elongate
shaft having a distal end at which the device frame is attached and
a proximal end having user controls by which a user can control the
operation of the device outside the patient's body after intraoral
placement of the device within the patient's gastrointestinal
tract.
[0017] The tissue engaging structure in the roller may include a
plurality of elongate tissue-capture chambers formed in the roller
and distributed radially about the roller, where the vacuum
conduits are operable to connect an external vacuum source to
successive capture chambers as the roller is rotated, in a
tissue-advancing direction, such that a tissue fold tissue is drawn
into and through said device by successive capture and release of
tissue in successive tissue-capture chambers.
[0018] The frame in the device may include a post on which the
roller is rotatably mounted about an axis. The post has a fixed
plate with a vacuum port in the vacuum conduit that is offset from
the axis. The roller may include a rotatable plate that confronts
and contacts the fixed plate when the roller is rotated. The
rotatable plate may include a plurality of elongate, recesses in
the vacuum conduit, each of which moves in an out of fluid
communication with the vacuum port in the first plate as the roller
is rotated, to successively communicate each tissue-capture
chambers in the roller with the vacuum port through the associated
elongated recess in the roller plate.
[0019] The device is preferably open at one end, and may further
include a clamping mechanism activatable to move the arm between an
open position in which the arm and roller can embrace a side region
of an already formed tissue fold and a closed condition in which a
tissue fold can be formed in the device by rotating the roller. The
arm may itself include a roller mounted thereon for rotation about
the arm's long axis.
[0020] The device may further include a fastener mechanism operable
to eject a fastener through a tissue fold captured between the
roller and support arm of the device, where one of the roller and
arm is adapted to carry and eject one or more fasteners. The
fastener mechanism may include an elongate slot defined in said arm
and adapted to hold in-line, a plurality of U-shaped fasteners,
each preformed to adopt the shape of a two-loop fastener when the
fastener is ejected from the slot, and a pusher for ejecting
individual fasteners from the slot. In another embodiment, the
fastener mechanism may include an elongate tube through which a
metal wire can be advanced, a distal end deflection member, and a
pusher for an advancing such a wire within the tube against the
deflection member, wherein the wire is coiled as it exits the tube
to form a coiled-wire fastener that fastens a tissue fold formed in
the device.
[0021] The device is designed for use in a method of acquiring a
tissue fold in a body tissue or organ, by the steps of: (a)
positioning against the body tissue or organ, an opposed-roller
tissue-acquisition device of the type described, (b) applying a
vacuum to the roller or arm of the device to adhere one of the two
tissue layers of a tissue fold, as tissue is advanced between the
roller and arm; (c) while applying said vacuum, engaging the drive
mechanism to rotate the roller in a direction that advances tissue
between the roller and arm; (d) continuing the rotating until a
desired-size tissue fold has been formed between the roller and
arm; (e) fastening the fold; and (f) releasing the fastened fold
from the device. Fastening step (e) may include ejecting a fastener
through the fold from the arm or roller.
[0022] For use in acquiring a tissue fold within the stomach,
positioning step (a) may include introducing the device into the
stomach intraorally and employing an endoscope to position the
device against a selected region of the stomach where it is desired
to form the tissue fold.
[0023] For use in forming an extended, continuous two-layer tissue
fold within the stomach, steps (a)-(e) may be repeated at each of a
plurality of locations along a preselected tissue-fold line within
the stomach, so as to form an elongate, continuous two-layer tissue
fold composed of at least three individually-fastened folds formed
in steps (a)-(e).
[0024] Where the tissue-acquisition device is open at one end,
positioning step (a) may include moving the device to a position in
which the open end of the device embraces a side portion of a
previously acquired and fastened tissue fold.
D. Auger-Blade Tissue-Acquisition Device and Method
[0025] Also disclosed is an auger-blade tissue-acquisition device
for acquiring a tissue fold. The device includes (i) a frame, (ii)
a pair of helical-surface augur blades that are mounted on the
frame for rotation about substantially parallel axes and for
movement toward and away from one another under a force that biases
the two blades toward one another, and (iii) a drive mechanism for
rotating at least one of the two blades in a selected
direction.
[0026] Each auger blade may have a proximal section of relatively
low pitch, a distal section of relatively high pitch, and a center
region of intermediate pitch, where the width of the each blade in
the proximal section is tapered on progressing toward the proximal
end of the blade. The two blades are mounted for rotation on a pair
of bases, and these bases are adapted to move toward and away from
one another, under a biasing force, allowing the blades to
accommodate tissue material as is acquired between the blades,
while maintaining the tissue under a moderate compression
force.
[0027] For use in forming a tissue fold in within the interior of
the gastrointestinal tract, the device further includes an elongate
shaft having a distal end at which the device is attached and a
proximal end having user controls by which a user can control the
operation of the device outside the patient's body after intraoral
placement of the device within the patient's gastrointestinal
tract.
[0028] The device may further include a fastener mechanism for
ejecting a fastener through a tissue fold formed by the device. One
such fastener includes a conduit through which a plurality of
pre-formed metal-wire segments can be advanced, and a pusher which
is operable to advance the segments within the conduit, where the
wire assumes a coiled configuration as it exits the tube to form a
coiled-wire fastener effective to fasten a tissue fold formed in
the device.
[0029] The auger-blade device is designed for use in a method of
acquiring a tissue fold in a body tissue or organ, by the steps of:
(a) positioning against the body tissue or organ, an auger-blade
tissue-acquisition device of the type described above, (b)
activating the drive mechanism, causing tissue to be drawn between
the two blades, thus forming a tissue fold; (c) fastening the
tissue fold formed between the two blades; and (d) releasing the
device from the fold by reversing the direction of blade
rotation.
[0030] For use in acquiring a tissue fold within the stomach,
positioning step (a) may include introducing the device into the
stomach intraorally, with the blades in their tissue-capture
condition, and employing an endoscope to position the device
against a selected region of the stomach where it is desired to
form the tissue fold.
[0031] For use in forming an extended, continuous two-layer tissue
fold within the stomach, steps (a)-(d) may be repeated at each of a
plurality of locations along a preselected tissue-fold line within
the stomach, so as to form an elongate, continuous two-layer tissue
fold composed of at least three individually-fastened folds formed
in steps (a)-(d).
E. Scissor-Arm Cage Tissue-Acquisition Device and Method
[0032] In another aspect, the invention includes a scissor-arm
tissue-acquisition device for acquiring and fastening a tissue
fold. The device has (i) a scissor-arm cage having an opening on
one side thereof; (ii) a flexible membrane covering said cage and
optionally, a portion of said opening; (iii) an drive mechanism for
expanding the cage from a low-profile, collapsed-arm condition to
an expanded-arm condition in which the cage defines a
tissue-capture chamber covered by the membrane, and (iv) a vacuum
port through which vacuum can be supplied to the tissue-capture
chamber, with the cage in its expanded-arm condition, to draw a
tissue fold into the chamber through said opening. The device may
further include a fastener mechanism, such as a linear stapler, or
clip-fastener or coiled-wire fastener of the types described
below.
[0033] For use in forming a tissue fold in within the interior of
the gastrointestinal tract, the device may further include an
elongate shaft having a distal end at which the device is attached
and a proximal end having user controls by which a user can control
the operation of the device outside the patient's body after
intraoral placement of the device within the patient's
gastrointestinal tract.
[0034] The device is designed for use in a method of acquiring a
tissue fold in a body tissue or organ, by the steps of (a)
positioning against the body tissue or organ, a scissor-arm
tissue-acquisition device of the type described above, (b) with the
cage in its expanded-arm condition, and the opening placed against
the body tissue or organ, applying vacuum to the cage, causing
tissue to be drawn into the cage, thus forming a tissue fold; (c)
fastening the tissue fold formed within the cage; and (d) releasing
the fold from the device by releasing the vacuum applied to the
cage.
[0035] For acquiring a tissue fold within the stomach, the
positioning step may include introducing the device into the
stomach intraorally, with the cage in its collapsed-arm condition,
and employing an endoscope to position the device against a
selected region of the stomach where it is desired to form the
tissue fold.
[0036] For use in forming an extended, continuous two-layer tissue
fold within the stomach, steps (a)-(d) may be repeated at each of a
plurality of locations along a preselected tissue-fold line within
the stomach, so as to form an elongate, continuous two-layer tissue
fold composed of at least three individually-fastened folds formed
in steps (a)-(d).
F. Hollow Tube Tissue-Acquisition Device and Method
[0037] In another aspect, the invention includes a hollow-tube
tissue-acquisition device for acquiring and fastening a tissue
fold. The device includes (i) an elongate hollow tube into which
tissue can be drawn with application of a vacuum to the tube and
(ii) stapler head carried at the distal end of the tube, and
movable between an open condition defining a chamber through which
tissue can be drawn into the tube, and a closed condition in which
a stapler assembly in the stapler head can be operated to fasten a
tissue fold drawn into the tube.
[0038] For use in forming a tissue fold in within the interior of
the gastrointestinal tract, the device further includes an elongate
shaft having a distal end at which the device is attached and a
proximal end having user controls by which a user can control the
operation of the device outside the patient's body after intraoral
placement of the device within the patient's gastrointestinal
tract.
[0039] The stapler assembly in the stapler head may be constructed
to hold a plurality of stacked staples, and include a staple
ejector for ejecting individual staples from the assembly, where
the head also includes an anvil frame on which the stapler assembly
is pivotally mounted and which provides an anvil surface for
crimping staples ejected from the stapler assembly. Alternatively,
the stapler head may include an elongate slot adapted to hold
in-line, a plurality of U-shaped fasteners each preformed to adopt
the shape of a two-loop fastener when the fastener is ejected from
the slot, and said pusher is operable to eject individual fasteners
from the slot. In still another embodiment, the stapler head may
include an elongate tube through which a metal wire can be
advanced, a distal end deflection member, and said pusher is
operable to advance such a wire within the tube against the
deflection member, wherein the wire is coiled as it exits the tube
to form a coiled-wire fastener effective to fasten a tissue fold
formed in the device.
[0040] The tube acquisition device is designed for use in a method
acquiring a tissue fold in a body tissue or organ, by the steps of
(a) positioning against the body tissue or organ, a hollow-tube
tissue-acquisition device of the type described, (b) activating the
stapler head to place the chamber defined by the head in its open
condition; (c) applying a vacuum to the device, to draw tissue
through the chamber into the tube, thereby to form a tissue fold;
(d) fastening the tissue fold, and (e) releasing the fastened fold
from the device.
[0041] For acquiring a tissue fold within the stomach, the position
step (a) may include introducing the device into the stomach
intraorally, with the device in its closed, low-profile condition,
and employing an endoscope to position the device against a
selected region of the stomach where it is desired to form the
tissue fold.
[0042] For use in forming an extended, continuous two-layer tissue
fold within the stomach, steps (a)-(e) in the method may be
repeated at each of a plurality of locations along a preselected
tissue-fold line within the stomach, so as to form an elongate,
continuous two-layer tissue fold composed of at least three
individually-fastened folds formed in steps (a)-(e).
G. Linear Stapler Device
[0043] In still another aspect, the invention includes a stapling
device for applying a linear array of staples to a tissue. The
device includes (i) a housing; (ii) a staple cartridge contained
within said housing for holding a plurality of staples in a linear
array; (ii) a pusher assembly having a plurality of pusher surfaces
arrayed to simultaneously engage respective staples held in said
cartridge, to eject the staples from the cartridge as the pusher
assembly moves in a bottom-to-top direction within the housing
between lowered and raised positions, and a linear array of pins
extending along at least one side of the pusher assembly; (iii) an
ejector assembly having at least one drive plate disposed within
said housing for movement in an end-to-end direction between load
and retracted positions, where the drive plate has a linear array
of angled slots formed in a side thereof, and in which pins in the
pusher assembly ride, such that movement of the drive plate from
its initial load toward its retracted position forces the pusher
assembly from its lowered to its raised condition; and (iv) an
anvil disposed adjacent the top surface of the housing, for
crimping staples ejected from the cartridge when the drive plate is
moved from its load to its retracted position.
H. Clip Fastener Device
[0044] Also disclosed is a multi-fire fastener device for fastening
two or more layers of material together. This device has (i) an
arm, (ii) an elongate slot formed in the arm, (iii) disposed in the
slot, one or more U-shaped fasteners, each having a pair of
elongate, side-by-side legs that are preformed to adopt the shape
of a loops when the fastener is ejected from the slot, and (iv) a
pusher for ejecting individual fasteners from the slot.
[0045] The slot in the device may have a trapezoidal
cross-sectional shape and a length dimensioned to accommodate a
plurality of fasteners arranged inline.
[0046] The fasteners may be composed of a titanium-containing alloy
such as nitinol, and may be formed by laser-cutting a
titanium-alloy tube having a thickness between 2 and 20 mils, and
an inner diameter between 60-120 mils.
I. Coiled-Wire Fastener Device
[0047] In a further aspect, the invention includes a coiled-wire
multi-fire fastener device for fastening two or more layers of
material together. The device has (i) a hollow feed tube; (ii) a
wire dimensioned for linear advancement within said tube, where in
one embodiment, the wire has a plurality of coil segments
interspersed with breakaway segments designed to break when the
wire is subject to a selected bending force, (iii) a deflection
member carried at the distal end of the tube for bending a coiled
segment of the wire into a coil, as the distal end portion of the
wire is advanced out of the feed tube, where each coil segment is
dimensioned to form at least a full-circle coil before the
next-in-line breakaway segment is bent and breaks as it passes over
the deflection member, and (iv) a pusher for advancing the wire
within the tube.
[0048] The breakaway segments of the wire may be tapered in wire
diameter on progressing in a distal direction, such that the region
of greatest susceptibility to breaking is the interface between a
coil segment and its trailing breakaway segment, such that each
successive coil segment has a tapered-diameter end as it is
advanced out of the tube.
[0049] The device may further include an anvil having a curved
deflection surface.
J. Barbed-Anchor Fastener Device
[0050] Also forming part of the invention is multi-fire
barbed-anchor fastening device for fastening two or more layers of
material together. The device includes a distal-end clamp having
first and second clamping arms that can be moved toward and away
from a closed, clamping condition, and first and second anchor
tubes that terminate distally adjacent the distal ends of the first
and second clamping arms, respectively. Carried in the first anchor
channel is a linear string of first anchor components, each having
a barb that is held in a retracted nested position within its tube
and which is based to swing outwardly when moved out of its anchor
channel. Carried in the second anchor channel, a linear string of
second anchor components, each having a socket to receiving such
first anchor-component barb, when the two anchor components are
pressed together, to form a locked anchor. First and second pushers
in the device functions to advance the first and second anchor
members, respectively, to load a distal-most anchor member at the
distal end of the associated clamping arm. A clamping mechanism in
the device is activatable to move the clamping arms, with such
loaded with first and second anchor members, toward their closed,
clamping condition, to fasten a tissue fold held between the two
arms.
[0051] These and other objects and features of the invention will
become more fully apparent when the following detailed description
of the invention is read in conjunction with the accompanying
drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0052] FIGS. 1A-1G illustrate various views of a patient stomach
during an operation in accordance with an aspect of the invention
for reducing stomach volume;
[0053] FIGS. 2A and 2B are simplified side and front-on views of a
roller-arm tissue-acquisition device constructed in accordance with
one embodiment of the invention;
[0054] FIGS. 3A-3D are sectional views taken through line 3-3 in
FIG. 2A, showing successive rotational position of a roller in the
device;
[0055] FIGS. 4A-4C are head-on views of the device in FIG. 2A,
showing successive capture and release of tissue during formation
of a tissue fold in the device;
[0056] FIGS. 5A and 5B are sectional views like those in FIGS.
3A-3B, but showing different pin configurations for the roller and
arm in the device;
[0057] FIGS. 6A and 6C are side sectional views for the device
shown in FIG. 2A, but showing how pins on the roller bend and slide
for tissue engagement and release at different rotational positions
of the roller, shown in FIGS. 6B and 6D, respectively;
[0058] FIGS. 7A-7E show various mechanisms for mounting an arm on
the device and for adjusting its position with respect to the
roller;
[0059] FIGS. 8A and 8B show a staple-holder and drive mechanism in
the arm of a tissue-acquisition device, where staple driving is
done either by a pushing or pulling action, respectively;
[0060] FIGS. 9A shows a cross-sectional view through a
tissue-acquisition device in which the staple holder and
staple-drive mechanism are contained in the roller of the device
(9A), and a cross-sectional view, through line B-B in FIG. 9A
showing staple firing from the roller (9B);
[0061] FIGS. 10A-10C illustrate the method for repairing a vertical
sleeve gastrectomy (VSG) in a patient, in accordance with an aspect
of the invention;
[0062] FIGS. 11A-11C illustrate an auger-blade tissue-acquisition
device constructed in accordance with yet another aspect of the
invention, shown in initial deployment (FIG. 11A), full-blade
deployment (FIG. 11B), and tissue-engaging condition (FIG.
11C).
[0063] FIG. 12 shows, in enlarged view, the shape of the helical
blades in the auger-blade device;
[0064] FIG. 13 illustrates elements of a wire loop fastener
mechanism in the device;
[0065] FIGS. 14A and 14B illustrate a scissor-arm
tissue-acquisition device formed in still another aspect of the
invention, shown in closed (FIG. 14A) and expanded (FIG. 14B)
conditions;
[0066] FIGS. 15A and 15B illustrate a hollow-tube
tissue-acquisition device acquisition device formed in still
another aspect of the invention, shown in closed (FIG. 15A) and
open (FIG. 15B) condition;
[0067] FIG. 16A-16C illustrate the operation of the stapling
mechanism in the hollow-tube tissue-acquisition device;
[0068] FIGS. 17 shows, in exploded view, a linear stapler device
formed in accordance with an aspect of the invention;
[0069] FIGS. 18A-18C illustrate three operational positions of the
linear stapler device of FIG. 17 in ejecting a linear array of
staples;
[0070] FIGS. 19A-19C illustrates the fastening of a two-layer fold
with a preformed fastener, under various conditions;
[0071] FIG. 20 shows fasteners in a slot formed in the arm or
holder of a tissue-acquisition device;
[0072] FIGS. 21A-21D show various types of two-arm fasteners before
and after ejection from a fastener holder;
[0073] FIGS. 22A and 22B are side sectional views of
tissue-acquisition devices having different arm-end geometries for
releasing fasteners from an arm in the device against a device
roller, shown in tissue-capture (22A) and tissue-fastening
conditions (FIG. 22B);
[0074] FIGS. 23A-23D illustrate in side sectional views, a
coil-wire fastener device in an open, tissue-acquisition condition
(23A), in an initial tissue fastening condition (23B), just before
completion of the fastening operation (23C); and just after the
wire in the device breaks at its distal end (FIG. 23D);
[0075] FIGS. 24A-24F are side views of three different embodiments
of a wire used in the coil-wire device in FIG. 23, where FIGS. 24B,
24D, and 24F are enlarged views of the circled regions in FIGS.
24A, 24C, and 24E, respectively.
[0076] FIGS. 25A-25E illustrate construction and operation of a
barbed-anchor fastener device constructed according to another
embodiment of the invention; and
[0077] FIGS. 26A and 26B show components of a retractable-barb
fastener used in the device 26A and the mechanism for portioning
the barb (26B).
DETAILED DESCRIPTION OF THE INVENTION
A. Method of Stomach Volume Reduction
[0078] In accordance with one aspect, there is provided a method
for treating an obesity-related eating disorder in a patient by
creating, an elongate continuous tissue plication in the anterior
wall, posterior wall, and/or fundus of a patient's stomach. The
terms "tissue plication" and "tissue fold" are used interchangeably
herein, and as applied to the present method, refer to a two-layer
tissue fold within the stomach having an serosal surfaces in
contact with one another.
[0079] The method preferably employs tissue-acquisition devices and
methods which will be detailed below in Sections C-E. For purposes
of this section, it is worth noting only that a device suitable for
the method (i) can be placed within the stomach intraorally at the
distal end of a flexible shaft also having user controls at its
proximal end, (ii) includes tissue-acquisition structure for
capturing and fastening a two-layer tissue plication within the
stomach, and (iii) can be moved along a linear region with the
anterior or posterior wall and/or fundus to successively capture
and fasten adjacent tissue regions, to form a single laterally
extending tissue fold that includes at least three
individually-fastened folds or plications.
[0080] The method is illustrated in FIGS. 1A-1G, where a patient's
stomach 20 is shown in sectional view approximately midway between
the dorsal (back) wall 22 and the ventral (front) wall, shown
fragmentarily at 24 in FIG. 1A. The fundus at the top of the
stomach is shown at 26. A tissue-acquisition and fastening device
28 is carried at the distal end of a flexible shaft 30 which is
dimensioned to allow intraoral access to preferably the entire
stomach from a user position outside the patient's mouth. For
simplicity, the tissue acquisition device is shown in the figures
simply as two confronting members 32, 34 between which a tissue
fold is to be acquired, as seen best in FIGS. 1A and 1B. In certain
roller-arm embodiments of a tissue-acquisition device, described in
Section C below, the two members include a roller and confronting
arm, where a vacuum is applied to one of the two members while the
roller functions to feed a tissue fold between the two members.
[0081] Although not shown, the proximal end of shaft 30 has
controls by which the physician can manipulate the operation of the
device. As will become apparent, the user controls allow control of
the position of the device in the stomach, the operation of the
device in acquiring a stomach plication in the anterior wall,
posterior wall and/or fundus in the stomach, the operation of the
device in fastening the just-acquired plication, and the operation
of the device in advancing to an adjacent region and extending the
plication. Also shown in the figures is an endoscope 36 by which
the user can view and guide the just-described operations.
[0082] After introducing the tissue-acquisition device into the
patient's stomach, the physician places the device against a
selected interior region of the stomach anterior wall 24, posterior
wall 22, or fundus, as shown in FIG. 1A. In a preferred embodiment,
the physician plans and selects a fold line along one or more of
these stomach surfaces along which an extended fold will be formed,
and places device 28 at one end of the planned fold line,
preferably the most distal point along the fold line, as indicated
in FIGS. 1A and 1B. Next, the physician operates the device to
acquire a serosa-to-serosa laterally-extending tissue fold or
plication, such as fold 40 in FIG. 1B, and fastens the fold, as
detailed below. As the term is used herein, a "laterally-extending
tissue plication" refers to a tissue plication having a two-layer
planar expanse whose height, above the base of the plication, is
smallest at the upstream and downstream ends of the plication, such
as upstream and downstream ends 40a and 40b, respectively in
plication 40 in FIG. 1B, and greatest at one or more interior
regions of the fold, indicated at 40c in FIG. 1B.
[0083] Once a first laterally-extending tissue plication is formed,
the device is moved to place it against a new selected interior
stomach region adjacent the fastened tissue fold just formed, such
that the device, when operated to acquire a tissue fold, will form
a new tissue plication whose "upstream" planar expanse portion
overlaps with a "downstream" planar expanse portion of the newly
formed plication, to form a single laterally-extending tissue fold
that includes the new fold and the previously formed fold. This
operation can be seen in FIG. 1C, which shows new fold 42 formed
adjacent fold 40, the two folds forming a single laterally
extending tissue plication. These steps are repeated one or more
times, as illustrated in FIGS. 1D and 1E, until an elongate,
continuous two-layer tissue fold 44 composed of at least three
individually-fastened folds, such as folds 40, 42, is formed in the
stomach's anterior wall, posterior wall, or fundus. FIG. 1F shows
an exterior tissue-fold line 46 as would be seen from the exterior
surface of the stomach, recognizing that this fold line is not
visible to the physician. As noted above, this fold line may be
formed along the anterior wall, posterior wall, and/or fundus of
the stomach.
[0084] FIG. 1G shows a cross-section of the stomach taken through a
plication region of the stomach along view line A-A in FIG. 1F. As
seen, the operation results in a relatively large mass of stomach
tissue in the form of an extended fold 44 being taken into the
stomach. The operation thus reduces stomach volume in two ways, by
reducing the total outer surface area of the stomach (which in
turn, defines the internal volume capacity of the stomach) and by
filling the internal volume with a relatively large tissue-fold
mass. In a preferred embodiment, the total volume of the stomach,
that is, the internal volume capable of receiving food, has been
reduced by at least 25%, and as much as 40% or more, e.g., up to
60-80% of the original stomach volume. If necessary, the operation
is performed along two of more of the target stomach areas (the
anterior wall, posterior wall and fundus) to achieve desired large
volume reductions.
[0085] In addition to the ability to significantly reduce stomach
volume, a related embodiment of the method is carried out until
there is formed a continuous length of tissue fold effective to
substantially reduce stomach motility, as evidenced by a reduction
in measured periodic motor activity after eating.
[0086] As will be detailed below, the tissue-acquisition device may
be open at one end, such that in acquiring an adjacent tissue fold,
the device can be moved to a position in which the open end of the
device embraces an adjacent side portion of a previously acquired
and fastened tissue fold.
[0087] The tissue-acquisition device may include an elongate
roller, a roller-confronting arm, and an arm-positioning mechanism
activatable to move the arm between open and closed conditions, as
described above and detailed in Section C. In other embodiments,
the tissue acquisition device includes an auger-blade acquisition
device (Section D), and a scissor-arm acquisition device (Section
E.) As will be seen, all three of these embodiments can be operated
to form a series of overlapping plications in which a downstream
portion of one plication becomes the upstream portion of the
next-in-line plication, resulting in a continuous, extended tissue
plication that is fastened along its length at the base of the
plication.
B. Method of Restoring a Vertical Sleeve Gastrectomy
[0088] A Vertical Sleeve Gastrectomy (VSG) procedure is a common
procedure for treatment of obesity. This procedure generates weight
loss solely through reduced stomach volume. In the procedure, the
stomach is restricted by stapling and dividing it vertically and
removing more than 85% of it. The portion of the stomach that
remains is shaped like a banana and measures from 1-5 ounces
(30-150 cc), depending on the specifics of the operation7. The
nerves to the stomach and the outlet valve (pylorus) remain intact
with the idea of preserving the functions of the stomach while
drastically reducing the volume. An advantage of the procedure is
that there is no intestinal bypass, avoiding the potentially
costly, long term complications such as marginal ulcers, vitamin
deficiencies and intestinal obstructions.
[0089] Over time, the patient's stomach may expand, and ultimately,
and as the stomach regains greater volume, the value of the
operation in limiting food intake is diminished. A post-surgical
stomach with much of its original volume regained is illustrated in
FIG. 10A. The present invention provides a simple procedure for
restoring the reduced stomach volume of the original procedure,
that is, restoring the original VSG stomach volume.
[0090] In the procedure, a surgeon initially places a tissue
acquisition and fastening device, such as device 46, within the
patient's stomach 45, by intraoral introduction. An exemplary
device suitable for the method is detailed in Sections C-F below.
The tissue-acquisition device is placed near the stomach-tissue
seam 48 formed during the vertical sleeve gastrectomy, and
typically near the lower end of the seam. The device is now
operated to acquire and fasten a two-layer tissue fold 49 that
includes a portion of the original VSG seam, as shown in FIG. 10B.
The device is now moved to place it against an adjacent stomach
region, such that the device, when operated to acquire a tissue
fold, will form a plication that contains another section of the
VSG seam. These steps are repeated along a length of the stomach
until the original VSG volume of the stomach is largely restored.
The method is designed to restore stomach volume to close to its
original post-VSG volume, as seen in FIG. 10C. Additionally, the
elongate plication 51 formed in the method incorporates the VSG
vertical seam 48, reducing the risk of infection or tearing of the
seam as internal pressure is applied to the seam. In a preferred
embodiment of the method, plication 51 is a continuous laterally
extending fold of the type formed in the method described in
Section A.
C. Roller-Arm Tissue Acquisition Device and Method
[0091] In another aspect, the invention includes a
tissue-acquisition device for acquiring a tissue fold or plication.
The device includes, in operative condition, a support frame; an
elongate roller mounted on the frame for rotation about the
roller's long axis; an arm mounted on the frame at a position
spaced from and confronting the roller, between which a two-layer
tissue fold is formed, and a roller driver. The roller includes
tissue-engaging structure for engaging tissue and advancing the
engaged tissue in the direction of roller rotation. A vacuum
conduit in the frame connects an external vacuum source to the
roller or arm, to hold one layer of a two-layer tissue fold by
vacuum adherence, as tissue is being advanced into and through the
device by rotation of the roller.
[0092] FIG. 2A is a simplified, side view of a tissue-acquisition
device 50 constructed in accordance with one embodiment of the
invention. The device include a frame 52, a roller 54 which is
mounted on the frame for rotation thereon, about the roller axis,
and an arm 56 which confronts the roller and defines therewith, a
tissue gap 58 in which a tissue fold is acquired. The roller
includes tissue engaging structure (described below) for engaging
tissue being acquired and can be rotated in a selected rotational
direction by an external or internal roller driver. In the
embodiment shown, the driver includes an external mechanism, such
as a motorized drill or manual key, for applying angular force, and
a cable 60 for transmitting torque from the driver to the roller,
this cable being contained within a flexible accessing shaft 62 to
which the device is attached. The roller has a cylindrical end cap
64 which is mounted on a post 66 on the frame for rotation thereon,
through its connection to driving cable 60 that extends through the
post.
[0093] With reference to FIG. 2B, roller 54 is scalloped along its
length, providing three elongate tissue-capture chambers, such as
chamber 70, which are distributed radially about the roller, and
which successively engage and release tissue, as the roller is
rotated. In the embodiment illustrated in FIGS. 2-7, the vacuum
conduit serves to connect the external vacuum source to the roller,
to provide a vacuum to each roller chamber successively as that
chamber advances toward arm 56 in a tissue-acquisition operation.
To this end, the vacuum conduit includes a sealed vacuum connection
between the end face 71 of post 66 and the confronting face 73 of
the roller (FIG. 2A), connecting an external vacuum source through
a conduit 68 in post 66. As seen best in FIGS. 3A-3D, where the
direction of rotation is indicated by arrow 72, the vacuum
connection includes a bean-shaped recess 74 formed in face 71 of
the post, and a vacuum port 76 at the end of conduit 68 in the
post. The confronting face of the roller cap has three vacuum
ports, one associated with each of the three chambers, such as port
76 associated with chamber 70. Each port is sealed by an 0-ring
(not shown) that rotates with the roller and which acts to seal the
connection between that port and recess 74, as the port moves over
the recess. As can be appreciated from FIGS. 3A-3D, rotation of the
roller in a clockwise direction in the figures brings each chamber
port and the associated chamber successively into vacuum
communication with recess 74 on the frame post, producing a vacuum
in chamber as the chamber approaches the bottom edge of arm 56
(about 6 clock in FIG. 3A), and which maintains the vacuum as the
chamber rotates into a confronting relationship with the arm (about
9 o'clock in FIG. 3B). Continued roller rotation brings each
adjacent chamber in an out communication with the vacuum source, as
can be appreciated from FIGS. 3C and 3D.
[0094] FIGS. 4A-4C illustrate the operation of the device in
acquiring a tissue fold, indicated at 80 in the figures. In FIG.
4A, the device has just been placed against a tissue region, where
vacuum applied to roller chamber 70 acts to draw a nascent tissue
fold 80 into the chamber. FIG. 4B shows the tissue fold being moved
into tissue gap 58 as chamber 70 is rotated to about a 9 o'clock
position. The figure also shows the next-in-line roller chamber
(near a 4 o'clock position) moving toward a "vacuum" position at
which that chamber will be connected to the vacuum and engage for
an adjacent tissue. This process is repeated at each 1/3 turn of
the roller, as shown in FIG. 4C, as each chamber is successively
connected to the vacuum source, draws tissue into the chamber,
moves the acquired tissue into the tissue gap, then releases the
tissue as the vacuum connection to that chamber is broken.
[0095] In an alternative embodiment, not shown, the vacuum
connection between the frame and successive roller chambers is
effected by three chamber-associated recesses, e.g., bean-shaped
recesses, formed in the roller cap face, for successively moving
across a single vacuum port formed in the confronting face of frame
post 66 as the roller is rotated, with a vacuum seal being provided
by an 0-ring covering the port in the frame post. In a related
embodiment, each of the three recesses formed in the roller cap are
replaced by a series of closely spaced individual ports that
maintain a continuous vacuum connection between the frame port and
each chamber, as the individual ports are moved across the fixed
vacuum port in the frame.
[0096] FIGS. 5A and 5B shows related embodiments of the device just
described. In FIG. 5A, a roller 82 has rows of pins, such as pins
84, 86, extending in both directions in each roller chamber, such
as chamber 88. The device in FIG. 5B includes a row of pins 90 near
the upper, exit edge of arm 92. In both embodiment, the pins can be
rigid, e.g., stiff metal pins, or flexible in the direction of
roller movement, to minimize tissue tearing as each chamber
releases its engaged tissue. This feature is further illustrated in
FIGS. 6A-6D which shows pins 84 in a straight condition when tissue
is first engaged (FIGS. 6A and 6B), and a bent condition when
tissue is released from a chamber.
[0097] FIGS. 7A-7E illustrate various embodiments of a roller-arm
device like that described above, but showing different arm
configurations and arm-positioning mechanisms used to move the arm
between an open condition in which the arm and roller can embrace a
side region of an already formed tissue fold, and a closed
condition in which a tissue fold can be formed in the device by
rotating the roller. In FIG. 7A, a device 94 has a roller 96
carried on a frame 100, and an arm 98 attached to a frame for
movement toward and way from the roller. The arm-positioning
mechanism, indicated at 106, is carried on frame 100 and is
activatable, e.g., by a solenoid, pneumatic cylinder, or worm-screw
mechanism, between extended and retracted conditions, to control
the position of the arm through a piston 109. The positioning
mechanism may be provided with internal spring biasing to allow
limited movement of the arm toward and away from the roller at the
arm's closed position, to accommodate variations in the thickness
of the plication being drawn between the roller and arm. A pin 104
carried on the frame rides within a elongate slot 102 formed in the
base of the arm, limiting vertical travel of the arm between the
closed position shown, and an open, extended position.
[0098] FIG. 7B shows a similar device 110 having a roller 112 and
arm 114 mounted on a frame 116, but where the arm is pivotally
mounted, at 118 on the frame for swinging movement between open (no
shading) and closed (cross-hatch shading) positions, under the
control of a solenoid 120 connected to the arm through a curved
piston 122.
[0099] In roller/arm device 124 shown in FIGS. 7C-7E, arm 128 has
are arcuate shape in side view, and is pivotally mounted on frame
130 at 132, for swinging movement between open (FIG. 7C) and closed
(FIG. 7E) positions, under the control of an arm-positioning
mechanism (not shown). A plate 134 pivotally mounted on the free
end of the arm allows the arm to track the surface of the tissue
fold during tissue acquisition; the ability of the plate to secure
a tissue layer can be enhanced by tissue-engaging pins, such as
shown at 136 in the embodiment of the device shown in FIG. 7D.
[0100] In another general embodiment, not shown, the roller has a
plurality of tissue-engaging projections distributed radially about
the roller, for engaging tissue as the roller is rotated in a
tissue-advancing direction, but the vacuum is applied to the arm,
such that tissue is drawn between the roller and arm by successive
engagement of the roller with new tissue, while a layer of tissue
fold opposite the roller is substantially immobilized by vacuum
adherence to the arm. For example, the roller may include a
stationary, slotted face structure having a outer surface facing
the arm, where tissue engagement is effected by pins that rotate
under the influence of the roller driver, extending through slots
in the face plate on the entrance side of the arm, and retracting
away from the face plate on the exit side of the arm.
[0101] The tissue-acquisition device of the invention may include
an independently movable and operable fastening mechanism, or may
incorporate a fastening capability into the arm and roller
structure of the device. FIGS. 8A and 8B illustrate a tissue
acquisition device 138 having a roller 140 and an arm 142 mounted
on a frame, as described above. Although not shown here, the device
may include an arm-positioning mechanism for moving the arm toward
and away from the roller. Arm 142 is provided with a plurality of
staple-holding slots, such as slots 146, each for holding a one or
more U-shaped staples (not shown) therein. The staples are ejected
from the arm by remotely pushing a rod 148 in a proximal-to-distal
direction, causing an angled pusher blade 150 to engage in a staple
plate 152, pushing the plate downwardly in the figure and ejecting
a staple toward the roller. In a tissue-fastening operation, the
arm is moved by the arm-positioning mechanism to a fastening
position close to the roller, to form a tissue gap of preferably
between 60-120 mils, and locked in place. Activation of the pusher
blade then ejects the first-encountered staple through the
compressed tissue fold and against the roller, which is positioned
to present an anvil surface to the arm, for fastening the staple
through the tissue. The device shown allows five such staple
operations, so that an extended tissue fold made up of up to five
individually fastened tissue folds can be formed with consecutive
tissue-acquisition and fastening steps.
[0102] The embodiment shown in FIG. 8B is similarly constructed,
except that the staple ejection blade, indicated at 150', is
operated in a distal-to-proximal direction, by applying a pulling
force to a pull rod 148' connected to the blade.
[0103] FIGS. 9A and 9B illustrate an embodiment of a
tissue-acquisition device 154 in which staples are held in and
ejected from the device roller, indicated at 156. As seen in FIG.
9A, roller 156 is formed of three laterally extending columns, such
as column 158, adjacent pairs of which define the three tissue
chambers, such as chamber 160, in the roller. Formed in each column
is a plurality of staple-holding slots, such as slot 162 in column
156, where the slots in each column may be arranged side-by-side in
a laterally extending direction (perpendicular to the plane of the
page), similar to the staple holding configuration shown in FIGS.
8A and 8B, but preferably near the free end of the roller only.
Thus, for example, a roller having two laterally arranged staple
slots in each column will contain a total of six staples that can
be used for tissue fastening during an operation. FIG. 9B shows two
laterally arranged slots 162 in a roller column, from the
perspective of the B-B view line in FIG. 9A. As seen, each slot
provides a staple plate 164 which, when moved from a raised to a
lowered position in the figure, e.g., by a staple-ejection
mechanism like that shown in FIGS. 8A or 8B, pushes a staple 166
from its slot, through a compressed tissue plication 168 and
against the device's arm 170, which serves as the anvil in a
stapling operation. In operation, once a suitable amount of tissue
fold has been formed in the device, the device arm is moved to a
position close to the roller, preferably within 60-120 mils of the
roller and locked into place. The staple ejection mechanism is then
activated to eject one or more staples through the compressed
tissue fold, against an anvil surface of the arm, to fasten that
fold.
[0104] In another embodiment, the fastening mechanism incorporated
into the tissue-acquisition device employs one or more U-shaped
fasteners, each having a pair of elongate, side-by-side legs that
are preformed to adopt the shape of loops when the fastener is
ejected from a staple slot. Typically, a plurality of such
fasteners are held in an end-to-end configuration in a slot formed
in the device arm and extending from the proximal end of the arm to
a distal tip, where the fasteners are ejected against a tissue
fold. In this embodiment, the roller-confronting arm is provided
with a channel through which the clips are advanced, and the roller
serves as the anvil. The roller-arm device can be similarly adapted
for use with the linear stapler described in Section H, the
coil-wire fastener described in Section J, and the barbed anchor
fastener described in Section K.
D. Auger-Blade Tissue-Acquisition Device and Method
[0105] Another tissue-acquisition device constructed in accordance
with the invention is the auger-blade device 202 seen in FIGS.
11A-11C. Shown here is the distal end of a flexible shaft 204 used
to access a hollow organ, e.g., the stomach, and to manipulate the
position of the device within the organ. It will be understood that
shaft 204 houses control elements, e.g., cable and/or pneumatic
tubes, for controlling the operation of the device remotely at the
proximal shaft end.
[0106] As seen in the figures, device 202 includes a pair of auger
blades 206, 208, each having three helical fins, such as fins 210,
212, 214, in blade 206 extending from central stem 216. As seen
best in FIG. 12, which shows the blades in enlarged view, each
blade fin has a relatively high helical pitch at its upper, distal
end, a relatively low helical pitch at its lower-proximal end, and
an intermediate helical pitch between the two blade ends. The high
helical pitch at the blades' distal ends has been found most
effective for engaging tissue, when the blades are placed against
tissue under operational conditions, described below. The
intermediate pitch between the two blade ends is effective in
maintaining a tissue grasp during operation, and the low pitch near
the bottom of the blades acts to avoid bunching of the tissue fold
formed during operation. As can be appreciated from FIGS. 11A and
11B, the two blades are partially interleaved to reduce the total
blade-to-blade width profile of the device to only slightly greater
than 3/8 inch, for limiting the diameter of shaft 204, which is
used in carrying the device into the stomach, to no more than about
half an inch.
[0107] With continued reference to FIGS. 11A-11C, blades 206, 208
are rotatably mounted on circular bases 218, 220, respectively. The
two bases, which form a frame 221 in the device, are slidably
mounted together for movement toward and away from one another, and
are biased toward the stacked, low profile condition seen in FIGS.
11A and 11B by a coiled spring (not shown). When tissue is acquired
during operation of the device, the captured tissue forces the
blades apart, to an offset condition such as seen in FIG. 12C, with
the spring biasing force acting to keep the blades pressed firmly
against the captured tissue.
[0108] Blade 206 in the device is connected to a rotational drive
201 provided in shaft 204 for rotating that blade during operation.
Although the opposite blade may also be under the control of a
rotating drive source, it is preferably free to rotate in response
to forces applied on it by the driven blade during tissue
acquisition. As can be appreciated, the two blades will
counter-rotate as tissue is fed by the driven blade between into
the gap between the two blades.
[0109] FIG. 13 shows elements of a fastener mechanism 211 in the
device. A wire-feed conduit 203 in this mechanism extends through
drive 201, base 218 (FIG. 11C) and stem 216 in blade 206 and
terminates at an opening 207 formed in the stem. The conduit
carries a plurality of pre-formed wire coil segments, such as
segments 209, which can be ejected, individually through opening
207 during operation of the device. The wire segments are preformed
to assume closed elliptical loops, such as loop 209, when they are
ejected from the conduit. The wire loop is dimensioned to encircle
two layers of a plication formed between the auger blades, to
fasten the captured tissue fold.
[0110] In operation, the device is introduced into an internal
organ, e.g., a stomach, with the blades and fastener fully
retracted within shaft 204. Once in the stomach, the device is
extended from the shaft and placed against the tissue to be
acquired, typically by placing the blades at an angle with respect
to the tissue, such that the blades contact the tissue both at
their distal ends and distal-end side regions. The blade drive
mechanism is now engaged to drive blade 206, resulting in tissue
take-up between the two blades, with the biasing force between the
two blades accommodating the additional bulk between the blades,
and serving to keep the plication being formed in a relatively
compressed condition. When a suitable amount of tissue fold has
been taken up, a pusher in the shaft is activated to expel a
pre-formed wire segment from opening 207, to fasten that tissue
fold. The blades are driven in the reverse direction to "unwind"
and release the fastened tissue. The procedure may be repeated for
successive folds, e.g., adjacent folds that will form a continuous
two-layer fold in the stomach.
E. Scissor-Arm Cage Device and Method
[0111] FIGS. 14A and 14B B show in perspective view, a scissor-arm
cage device 224 for use in forming a tissue fold, in accordance
with another aspect of the invention. The device is carried art the
distal end of an intraoral-access shaft 242 through which a drive
mechanism and vacuum tube are supplied to the device through a
flexible shaft connector 243. The shaft, which forms part of the
device, also provides a channel 252 for an endoscope and a channel
250 through which staple cartridges can be removed and resupplied
to the device during operation, as described below.
[0112] The device has a rigid frame 226 formed by a lower and upper
rectangular frame members 228 and 230, respectively, where the
lower frame member defines an opening 232 for tissue acquisition.
The two frame members are joined by a scissor-arm structure 234 in
the frame which is expandable from collapsed-arm condition, shown
in FIG. 14A, which provides a low profile for intraorally accessing
the stomach, and the expanded-arm condition shown in FIG. 14B, for
tissue acquisition within the stomach. As can be appreciated, the
scissor-arm structure is movable between its collapsed and expanded
positions by movement of slider pins 236, 238 which move within
slots 240, 242 formed in the upper and lower frame members,
respectively. The lower pin is connected to a worm drive 243, which
can be activated remotely, once the device is in the stomach, to
place the device in its tissue-acquisition position, and to place
the device in its low-profile condition for removal from the
stomach.
[0113] Frame 226 is covered by a flexible membrane, indicated by
lines at 225, formed over the structure 234 and the upper end of
the frame, but not opening 232 at the lower end of the frame. With
the cage in its expanded condition, the membrane forms a columnar
tissue-chamber 240 having a lower tissue-acquisition opening 232
and a rectangular cross-section. Vacuum is supplied to the chamber,
during a tissue-acquisition operation, by a vacuum port in the
chamber (not shown) connected to an external vacuum source. Where
the device is designed for intraoral use, it is carried at the
distal end of a flexible shaft for intraoral access, such as
indicated at 242.
[0114] Device 224 also further includes a fastening mechanism, such
as the linear stapler shown at 224, and described in detailed in
Section G below. Briefly, the fastener includes a staple cartridge
246 which holds a linear array of staples and which can be operated
remotely to simultaneously eject the array of staples, such as
staple 247 shown in the figure, and an anvil 248 which is moveable
between an retracted position which allows tissue acquisition into
the opening of the device, and a fastening position in which the
anvil is moved toward the staple holder to (i) squeeze a tissue
fold capture in the tissue chamber and (ii) provide an anvil
surface against which the ejected staples are crimped over the
tissue fold, to fasten the same. The anvil is pivotally mounted on
a pair of arms (not shown) which can be operated to pivot
outwardly, across the cage opening, to place the anvil in its
fastening position adjacent the stapler housing. Once the staples
are fired, and the captured tissue is fastened, the cartridge can
be removed and replaced through a channel 250 in shaft 242, with
the shaft retained in place in the patient's throat, esophagus and
stomach. As seen in FIG. 14B, the shaft also includes a channel for
an endoscope. Alternatively, the fastener in device 224 device may
incorporate a multi-fire fastener, such as the one of the fasteners
described below in Sections H, I, and J.
[0115] In operation, the device is placed in its collapsed arm
condition for intraoral placement, and its open end then placed
against a selected tissue region, e.g., along a preselected fold
line in the stomach. Screw-drive 243 is remotely activated to
expand the chamber, and vacuum is supplied to the chamber to draw a
tissue fold into the chamber. The fastener is then actuated to (i)
move the anvil into a position that squeezes the tissue fold
between the anvil and staple head, and (ii) eject one or more
staples through the base of the squeezed tissue fold.
[0116] If it is desired to capture an adjacent tissue fold, in
practicing the method for stomach volume reduction described in
Section A, the cage is removed from the first fold, by release of
chamber vacuum, and placed so that its opening straddles a side
portion of the just-formed fold and a "basement" region of the
adjacent tissue. When vacuum is again applied in the chamber, a
fold of tissue that is continuous with the just-made fold, but
which extends the fold in a downstream direction, is created. This
process may be repeated until a desired-length of continuous
two-layer fold is formed.
F. Hollow Tube Tissue-Acquisition Device and Method
[0117] In another aspect, the invention includes a hollow-tube
tissue-acquisition device 254 for acquiring and fastening a tissue
fold. As seen in FIGs. 15A and 15B, device 254 has an elongate,
flexible hollow tube 256 into which tissue can be drawn with
application of a vacuum to the tube, via a vacuum tube supplied
through a shaft, whose connection to tube 256 is shown at 258. The
shaft is designed and dimensioned for introducing the device
intraorally into a patient's stomach, and includes proximal-end
controls by which a user can control the operation of the device
outside the patient's body after intraoral placement of the device
within the patient's gastrointestinal tract. The shaft also
accommodates an endoscope (not shown) used for viewing within the
stomach.
[0118] A stapler head 260 carried at the distal end of the tube
includes a stapler assembly 262 and an anvil frame 264. The stapler
assembly is pivotally mounted at 266 on an anvil frame 264 for
pivoting movement between an open position (FIG. 15B) in which
tissue can be drawn into the tube, and a closed, stapling condition
(FIG. 15A and 16A-16C). The stapler assembly position is controlled
by a cable or the like (not shown) which can be operated remotely
to move the assembly between its open and closed conditions. The
sides of the fastener are covered by a flexible membrane 268 which
forms with the stapler assembly and anvil frame, a distal-end
chamber 270 through which tissue can be drawn into tube 254, when a
vacuum is applied to the tube, through a vacuum tube carried in the
shaft of the device.
[0119] As seen best in FIG. 16A-16C, anvil frame 264 provides a
vertically extending arm 270 which terminates near its distal end
in a curved anvil surface 274. Stapler assembly 262 has a staple
holder 275 for holding a stack 277 of staples at a fixed position
in the assembly. The drive mechanism for ejecting staples from the
assembly includes front and back assembly plates 274, 276,
respectively, and a wedge member 278 disposed between the plates,
and attached to a cable (not shown) which is pulled to activate
staple driving. The front plate, which is pivotally mounted in the
assembly at 280, carries at its distal end, a staple driver 284 for
engaging and ejecting the top-most staple, such as staple 284, in
the staple stack. As can be appreciated from the series of moved
positions in FIGS. 16A-16C, pulling wedge member 278 in a proximal
direction, i.e., top-to-bottom direction in the figures, causes
plate 274 to pivot toward the anvil, which in turn causes the
staple driver to engage and eject the topmost staple in the stack,
forcing it through a tissue fold captured at the end of the
fastener and crimping it against the anvil.
[0120] In operation, for use in acquiring a tissue fold in a body
tissue or organ, the device is introduced into the patient's
stomach or other internal organ, with the fastener in its closed,
low-profile condition. Once opened, the distal end chamber formed
by the stapler head is positioned against the body tissue or organ,
and a vacuum is applied to draw tissue through the distal-end
chamber into tube 256, forming a tissue fold within the tube. The
stapler assembly is then moved to its closed condition to clamp the
tissue fold at its base, and then activated to eject a staple
across the squeezed tissue fold. Once the fold is fastened, the
staple holder is opened, allowing the tube to be withdrawn and
either removed from the patient's stomach or placed at another
position for additional tissue acquisition and stapling. In
particular, for use in forming a series of in-line folds within the
stomach, the steps above are repeated along a preselected
tissue-fold line within the stomach.
G. Linear Stapler Device
[0121] FIG. 17 shows, in exploded view, a linear stapler device 286
constructed in accordance with an aspect of the invention, and
designed to fasten tissue, such as a two-layer tissue fold, with a
linear array of simultaneously applied staples.
[0122] The device includes a staple cartridge 288 having a
plurality of U-shaped slots for holding a linear array of staples,
such as slot 290 holding a U-shaped staple 291, seen in FIGS. 18B
and 18C. A pusher assembly 292 in the device is formed of a pair of
side bars 294, 296 that support between them a plurality of pusher
elements, such as elements 298, that are positioned to engage the
lower surfaces of the staples held in the associated slots in the
cartridge. Each side bar in the pusher assembly is provided with a
row of pins, such as pins 300, for a purpose to be described.
[0123] An ejector assembly 302 in the device includes a pair of
pusher plates 304, 306 that are each fastened at their right end
regions in the figures to an end connector 308 (FIGS. 18A-18C) that
is turn is attached to a drive mechanism 310, such as a worm drive.
The interior-facing sides of the plates are provided with a
plurality of slots, such as slots 312 seen in plate 306 in FIG. 17
and slots 313 seen in plate 304 in FIGS. 18A-18C, and having the
angled configuration seen in FIG. 17. In its assembled state, the
pins on opposite sides of the ejector assembly are carried in
associated slots in plates 304, 306, and the entire device is
encased in a housing 314 that holds the staple cartridge in a
stationary position and allows the ejector assembly to be moved in
a distal direction (left-to-right in the figures) relative to the
staple cartridge toward a retracted position.
[0124] Completing the description of the device, an anvil 316 is
supported above the staple housing on a pair of supports 318 that
are movable, by means of a suitable mechanism in the device, toward
and away from a position in which the anvil can function to (i)
squeeze a tissue fold captured between the anvil and staple
housing, and (ii) provide crimping surfaces for crimping staples
that are ejected from the staple cartridge, through a tissue fold,
against the anvil.
[0125] The operation of the device in ejecting a linear array of
staples is illustrated in the sequence of FIGS. 18A-18C. In 18A,
the ejector assembly is in an initial load position in which pins
300 in the pusher assembly are carried in the lower ends of slots
312 in the two plates of the ejector assembly. As the ejector
assembly is pulled to the right in FIG. 18B, the pins in the pusher
assembly are forced upwardly within the angled slots in the moving
plates, forcing the staples upwardly within the staple cartridge.
In FIG. 18C, the staples are shown completed ejected from the
cartridge as the ejector assembly is pulled to a fully retracted
position in which pins 300 have been forced into the upper ends of
the associated slots.
[0126] According to the invention, the linear stapling device
assembly is readily adapted for integration into each of the four
tissue-acquisition devices described in Sections C-F above. For
example, the fastener holder described with respect to each
acquisition device may be modified to provide the above-described
cartridge and ejector assembly within housing 314, and the anvil
described with respect to each acquisition device can be modified
to provide the anvil in the current device. Alternatively, the
linear stapler may be used as an independently operated stapling
device.
H. Clip Fastener Device
[0127] FIGS. 19-21 illustrate aspects of the fastener and fastening
device that may be used in a surgical procedure to fastening two
tissue layers 322, 324. The delivery device includes an elongate
arm 326 having an internal channel or slot 328 which accommodates
one or more U-shaped fasteners, such as fastener 330 seen in FIG.
21D. The slot preferably has a trapezoidal cross-sectional shape
and a length dimensioned to accommodate a plurality of fasteners
arranged inline, as seen in FIG. 20.
[0128] Fastener 330 has a pair of elongate, side-by-side legs 332,
334 attached to a base portion 336 (FIG. 21D). The legs are
preformed to adopt the shape of loops, as shown in FIG. 21C, when
the fastener is ejected from arm 326. In one embodiment, for use in
the tissue-acquisition and fastening method above, the fastener may
be formed by laser cutting a titanium-ally tube, such as a nitinol
tube, having the wall thickness of between 5 and 20 mills, and an
inner diameter between 60-120 mils. The cut, tube-like structure is
then forced into the fastener-arm slot, where it is constrained in
a straightened condition, as in FIG. 20. When the fastener is later
ejected from the arm, by the action of a pusher acting against the
left end of the fasteners in FIG. 20, the fastener will return to
its original shape, where the loops in the fastener, seen in FIG.
21C, will have approximately the original diameter of the tube from
which the fastener was cut. In the specific embodiment references
above, the loops will return to a diameter of between 60-120 mils,
suitable for fastening a compressed stomach tissue fold.
[0129] FIGS. 21A and 21B illustrate other embodiments of the
fastener of the invention. Fastener 338 in FIG. 21A has the same
design, but substantially shorter legs, and thus smaller fastener
loops. Fastener 190 in FIG. 21B has a single leg that returns to a
single fastening loop after deployment.
[0130] FIGS. 19A-19C illustrate various fastener orientations in
fastening a two-layer tissue fold. In FIG. 19A, fastener arm 326 is
oriented at right angles to the tissue fold, but not pressed firmly
against the fold. As seen, the expelled clip may not fully engage
both tissue layers in this configuration. This problem can be
overcome by pressing the tip of the arm more firmly against the
tissue fold, compressing it to the thickness of a single tissue
layer, as shown in FIG. 19B. Alternatively, the clip can engage
both layers when arm 326 is place at a fairly steep angle with
respect to the tissue, as seen in FIG. 19C.
[0131] FIG. 22A shows an embodiment of a tissue-acquisition device
342 of the type described above having a roller 344 and arm 346
carried on a frame 348, for capturing a tissue fold in a tissue gap
350 between the roller and arm. As seen, arm 346 is provided with
an internal slot 352 for holding a plurality of fasteners 354 in an
end-to-end fashion, and is curved toward the roller at its open,
distal end 356, for ejecting fasteners into a tissue fold captured
between the roller and arm end, by activation of a pusher (not
shown) in the arm.
[0132] In operation, device 342 is initially placed along one end
of a fold line, and with the arm moved to a closed condition, the
roller is operated to capture a tissue fold within tissue gap 350.
When a desired amount of tissue has been captured, the arm is moved
to a fastening position at which the tissue fold is squeezed
between the roller and arm end, and the pusher is activated to
eject a single fastener at an angle to the tissue fold, which
fastens the tissue fold by self-forming loops, as illustrated in
FIG. 19C. The arm of the device is then moved to its expanded, open
condition, and the device is moved to an adjacent region at which a
distal end portion of the device embraces a side of the just-formed
fold. The arm is now moved again to its closed condition, and the
tissue acquisition and fastening process is repeated to extend the
original fold. By providing the device with N fasteners in the arm,
a continuous elongate fold formed of a total of N individual folds
can be produced.
[0133] FIG. 19B shows the same device 342, but where the distal end
of arm 346' is bent to engage a tissue fold, shown at 358 in the
figure, at a substantially right angle. The distal-end
configuration is designed to press firmly into the fold, as in FIG.
19B, to ensure that the released clip forms engages both layers of
the tissue fold.
[0134] According to the invention, the clip fastener device is
readily adapted for integration into each of the four
tissue-acquisition devices described in Sections C-F above. For
example, the fastener holder described with respect to each
acquisition device may be modified to provide a slotted arm
carrying the pre-formed clips, and the anvil described with respect
to each acquisition device can be modified to form a surface for
supporting a tissue fold during clip ejection. Alternatively, the
clip fastener may be used as an independently operated stapling
device.
I. Coil-Wire Fastener Device
[0135] A third tissue-fastener device 360 constructed in accordance
with the invention is shown in side view in FIGS. 23A-23D, where
the four figures illustrate four operational stages of the device.
Briefly, the device has a wire-feed plate 362 and an anvil plate
364 which are movable toward and away from one another between an
open condition shown in FIG. 23A, which also shows a tissue fold
366 positioned between the plates, and a closed, clamping condition
shown in FIGS. 23B-23C, which shows the same tissue fold being
squeezed for fastening (FIG. 23B), and with a coil-wire fastener
368 partially formed in the fold (FIG. 23C). FIG. 23D shows the
device moved back to its open condition after fastening the tissue
fold with the completed coil-wire fastener. The two plates, which
are seen in side view in the figures, are moved between open and
closed positions by a remotely driven worm drive (not shown),
although any suitable drive mechanism for raising and lowering the
anvil plate relative to the wire-feed plate may be employed.
[0136] With continued reference to the figures, wire-feed plate 362
provides a straight wire channel 370 through which a wire 372 is
fed to the plate in a right-to-left direction in the figures from a
downstream wire-delivery tube 374. A deflection member 376 at the
open end of the channel 370 functions to deflect the fed wire in an
upward direction in the figures as the wire is advanced into and
through the tissue fold, as seen in FIG. 23C. In addition, anvil
plate 364 provides a semi-circular track 378 that further bends the
wire toward a circular coil as the wire is advanced through and
over the top of the tissue fold, and back through the fold in the
opposite direction.
[0137] FIGS. 24A-24E illustrate various wire configurations that
are contemplated for the device, where the direction of wire feed
is in a right-to-left direction in the figures, consistent with
FIG. 23, as indicated by arrows 381. FIGS. 24A and 24B show a
continuous wire 380 having a plurality of coil-wire segments, such
as segments 382, 384, separated by breakaway segments, such as
segment 386 (FIG. 24B), composed of a tapered section 388 at the
upstream end of segment 384, and a small-diameter link 390 joining
the tapered section to the base of the downstream end of segment
382, as seen in FIG. 24B. Wire 380 is designed to break at the
downstream end of each coil-wire segment, as the downstream end of
the segment encounters and is bent by the deflection member in the
device. That is, the small-diameter link is sufficiently thin that
the bending force it encounters at the deflection member is
sufficient to snap it and release the next-in-line segment. This
both allows the wire to form a series of identical-length coil-wire
fasteners, without having to separately shear the wire, and also
provides a tapered upstream end on each new wire segment, to
facilitate entry of the segment into a tissue fold.
[0138] FIGS. 24C and 24D show a discontinuous wire 392 having a
plurality of nested wire segments, such as segments 394, 396, which
are joined end-to-end by nesting a pointed tip 398 at the upstream
end of one segment, such as segment 394, in the downstream end
channel in an adjacent segment, such as downstream channel 400 in
segment 396. As can be appreciated, the nesting arrangement allows
the coil wire segments to form desired-size coil fasteners without
cutting, and provides a pointed tip for facilitating entry of each
wire into a tissue fold.
[0139] FIGS. 24E and 24F show a discontinuous wire 402 having a
plurality of blunt-end wire segments, such as segments 404 and 406,
which abut one another as the wire is being advanced through a feed
tube. The configuration allows the coil wire segments to form
desired-size coil fasteners without cutting.
[0140] In operation, the device is positioned with its wire-feed
and anvil plates positioned about a tissue fold to be fastened, as
shown in FIG. 23A, and the plates are brought together to squeeze
the fold prior to fastening, as shown in FIG. 23B. The wire in the
feed tube is then advanced in a right-to-left direction in the
figures, causing the next-in-line wire segment to deflect toward
the fold, penetrate the fold, then curve backwards on itself in
forming a coil-wire loop fastener, as shown in FIG. 23C. In the
embodiment shown in FIGS. 24A and 24B, the deflection force snaps
the wire at the downstream end of a coil-wire segment, releasing
the coiled segment from the next-in-line segment in the feed tube.
In the other embodiments shown, each wire segment is simply
released when coiled-wire formation is complete. Once the tissue is
fastened, the feed and anvil plates are opened to release the fold
and move to a next fold or fold region to be fastened, in a
multi-fire operation.
[0141] According to the invention, the coil wire fastener device is
readily adapted for integration into each of the four
tissue-acquisition devices described in Sections C-F above. For
example, the fastener holder described with respect to each
acquisition device may be modified to provide a feed tube by which
the fastening wire can be advanced toward a deflection member in
the fastener holder, and the anvil described with respect to each
acquisition device can be modified to provide a curved, e.g.,
semi-circular track by which advanced wire is further bent toward a
circular wire fastener.
J. Barbed-Anchor Fastener
[0142] Another tissue-fastening device constructed in accordance
with the invention is shown at 408 in FIGS. 25A-25E. The device is
carried partially within and also extends from the distal end of a
flexible shaft 410, by which the device can be introduced into a
hollow organ, e.g., a patient's stomach, and which provides, at its
proximal end, user controls for controlling the operation of the
device, as will be appreciated from the description of the device
below. The shaft may include an endoscope, not shown, for use in
visualizing the placement of fastener anchors at tissue-fold
sites.
[0143] The fastening device includes first and second clamping arms
410, 412 that are pivotally mounted in a scissor arrangement for
moving the distal ends of the arms toward and away from a closed,
clamping condition, shown in FIG. 25E. The drive mechanism for
clamp closure is a valve that rapidly forces the proximal sides of
arms 410, 412 outwardly, acting to drive the distal end sides
toward their clamping condition, although any suitable mechanical
or pneumatic control mechanism may be employed.
[0144] The fasteners in device 408 are composed of male and female
anchor components 416, 418, respectively, that are supplied to the
distal clamping ends of the clamping arms through
extendable/retractable supply channels 420, 422, respectively,
shown in FIGS. 25B and 25C. A first pair of linear pushers (not
shown) in the device function to advance anchor members within
their associated supply channels. A second pair of
retractable/extendable pushers (not shown) function to advance the
two supply channels to an extended position, shown in FIG. 25C, for
positioning a pair of anchor components at the distal ends of the
clamping arms, and for retracting the two supply channels prior to
a clamping and fastening operation, shown in FIG. 25E.
[0145] With reference to FIG. 26A, anchor component 416 has a
barrel-shaped body 424 that has upper and lower grooves 430, 432,
respectively, seen in FIGS. 26A and 26B. A barb 426 is mounted in
the body, within groove 430, for pivoting movement between the
retracted position seen in sectional outline in FIG. 26A and the
extended, clamping position shown. Anchor component 418 has a
barrel shaped body 419, and a cylindrical channel 428 formed in the
body. As can be appreciated in FIG. 26A, the barb is designed to be
locked within this channel when the two components are clamped
together.
[0146] With reference of FIG. 26B, the distal end of supply channel
420 has a pivotally mounted detent 433 which rides within groove
432 of component 416 as the component is moved toward its distal
end clamping position, engaging the associated barb in the
component and moving it from its retracted to extended
position.
[0147] In operation, the supply-tube pushers are first activated to
advance the supply channels 420, 422 to a position where a single
pair of anchor components is placed at the ends of the clamping
arms, as indicated by the series of steps shown in FIGS. 25B-25D.
With a pair of anchor members held at the distal ends of the arms,
as shown in FIG. 25D, the supply tubes are retracted and the loaded
clamp is positioned for clamping a tissue fold. The valve
controlling clamping movement is now activated, squeezing the
tissue fold and driving the male member barb through the tissue
fold and into engagement with the female component, to fasten the
fold. The clamp arms are then returned to their open condition,
shown in FIGS. 25A, readying the device for the next tissue
fastening operation.
[0148] According to the invention, the barbed anchor fastener
device is readily adapted for integration into each of the four
tissue-acquisition devices described in Sections C-F above. For
example, the fastener holder described with respect to each
acquisition device may be modified to provide a feed tube by which
the male anchor members in the present fastener can be advanced
toward a distal-end clamping position, and the anvil described with
respect to each acquisition device can be modified to provide a
feed tube by which the female anchor members in the present
fastener can be advanced toward an opposing distal-end clamping
position.
[0149] Although the invention has been described with respect to
specific aspects, embodiments, and applications, it will be
appreciated that various changes and modification may be made
without departing from the invention as claimed.
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