U.S. patent application number 11/760687 was filed with the patent office on 2007-10-04 for devices and methods for placement of partitions within a hollow body organ.
This patent application is currently assigned to SATIETY, INC.. Invention is credited to James Gannoe, Craig Gerbi, Andrew H. Hancock, Christopher Julian, Crystine M. Lee, Alex T. Roth, Gary Weller.
Application Number | 20070233161 11/760687 |
Document ID | / |
Family ID | 38134826 |
Filed Date | 2007-10-04 |
United States Patent
Application |
20070233161 |
Kind Code |
A1 |
Weller; Gary ; et
al. |
October 4, 2007 |
DEVICES AND METHODS FOR PLACEMENT OF PARTITIONS WITHIN A HOLLOW
BODY ORGAN
Abstract
Devices and methods for tissue acquisition and fixation, or
gastroplasty, are described. Generally, the devices of the system
may be advanced in a minimally invasive manner within a patient's
body to create one or more plications within the hollow body organ.
A tissue treatment device attached to a distal end of a flexible
elongated member and has a cartridge member opposite an anvil
member. The cartridge member and the anvil member are movable
between a closed position and an open position relative to one
another, and the cartridge member is re-loadable with a removable
staple cartridge to form multiple plications within the organ with
the same tissue treatment device.
Inventors: |
Weller; Gary; (Los Gatos,
CA) ; Roth; Alex T.; (Redwood City, CA) ;
Julian; Christopher; (Los Gatos, CA) ; Gannoe;
James; (West Milford, NJ) ; Hancock; Andrew H.;
(Fremont, CA) ; Gerbi; Craig; (Half Moon Bay,
CA) ; Lee; Crystine M.; (San Francisco, CA) |
Correspondence
Address: |
FULWIDER PATTON LLP
HOWARD HUGHES CENTER
6060 CENTER DRIVE, TENTH FLOOR
LOS ANGELES
CA
90045
US
|
Assignee: |
SATIETY, INC.
2740 EMBARCADERO WAY
PALO ALTO
CA
94303
|
Family ID: |
38134826 |
Appl. No.: |
11/760687 |
Filed: |
June 8, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11324135 |
Dec 29, 2005 |
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|
11760687 |
Jun 8, 2007 |
|
|
|
10797303 |
Mar 9, 2004 |
|
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11324135 |
Dec 29, 2005 |
|
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Current U.S.
Class: |
606/139 ;
606/220 |
Current CPC
Class: |
A61B 17/29 20130101;
A61B 2017/00278 20130101; A61B 2017/07214 20130101; A61B 17/07207
20130101; A61B 17/3474 20130101; A61B 17/072 20130101; A61B
2017/306 20130101; A61B 90/92 20160201; A61F 5/0086 20130101; A61B
2017/003 20130101; A61B 2017/00557 20130101; A61B 2017/07221
20130101; A61B 2090/0811 20160201; A61B 17/105 20130101; A61B
2017/07271 20130101; A61B 17/0218 20130101 |
Class at
Publication: |
606/139 ;
606/220 |
International
Class: |
A61B 17/10 20060101
A61B017/10; A61B 17/50 20060101 A61B017/50 |
Claims
1-26. (canceled)
27. A method for delivering and implanting a staple line in the
stomach of a patient, comprising: providing an elongated tubular
member having a proximal end and a distal end and having a first
lumen extending at least through a portion thereof; advancing the
distal end of the tubular member transorally into the patient's
stomach; advancing an endoscope through the first lumen for real
time visualization of the patient's stomach; positioning the
endoscope to visualize a treatment site in the stomach; position
the distal end of the tubular member at the treatment site and
visualize the position of the distal end of the tubular member with
the endoscope; implant a staple line at the treatment site while
visualizing with the endoscope; visualize the staple line with the
endoscope; and withdraw the tubular member and endoscope from the
patient.
28. The method of claim 27, wherein the endoscope is retroflexed to
visualize the distal end of the tubular member.
29. The method of claim 28, wherein the endoscope, when in the
retroflexed position, visualizes a proximal end of a fastening
member aligned with the gastroesophogeal junction (GEJ).
30. The method of claim 27, wherein the endoscope retracts stomach
tissue.
31. The method of claim 27, wherein dual folds of tissue are
fastened together by the staple line.
32. The method of claim 27, wherein the staple line is placed along
the lesser curve of the stomach.
33. A delivery system for transoral treatment of the stomach of a
patient, comprising: a flexible elongated body having a proximal
end extending outside the patient, a central section extending
transorally into the patient, and a distal end extending into the
stomach; a fixation member attached to the distal end of the
flexible elongated body; an endoscope associated with the flexible
elongated body for real time visualization; and the flexible
elongated body, fixation member, and endoscope having an overall
diameter equal to or less than 18.136 mm (0.714 inch).
34. The delivery system of claim 33, wherein the flexible elongated
body being compatible with side-by-side insertion of the
endoscope.
35. The delivery system of claim 33, further comprising an
acquisition member attached to the distal end of the flexible
elongated body.
36. The delivery system of claim 35, wherein the acquisition member
is a vacuum pod.
37. The delivery system of claim 36, further comprising a vacuum
tube extending from the vacuum pod at the distal end of the
flexible elongated body to the proximal end of the flexible
elongated body.
38. The delivery system of claim 37, wherein the vacuum tube is
attached to a vacuum source at a proximal end of the flexible
elongated body.
39. The delivery system of claim 33, wherein one or more cables or
wires extend along the flexible elongated body for operative
engagement with the fixation member.
40. The delivery system of claim 33, wherein the fixation member
has a maximum diameter of 15.1 mm (0.595 inch) in a closed
configuration and a maximum diameter of 17.0 mm (0.668 inch) in an
open configuration.
41. The delivery system of claim 33, wherein the flexible elongated
body can be bent to achieve a 10.16 cm (4.00 inch) bend radius to
flexibly navigate the esophagus.
42. The delivery system of claim 33, wherein the fixation member is
configured to place a line of fasteners through stomach tissue
having a length in the range from about 12.5 mm (0.492 inch) to
about 50.0 mm (1.97 inch).
43. A delivery system for transoral treatment of the stomach,
comprising: a flexible elongated member having a proximal end
extending outside of a patient, a central section extending
transorally into the patient, and a distal end extending into the
stomach; a tissue treatment device attached to the distal end of
the elongated member; a first lumen extending within the elongated
member and being in fluid communication with a vacuum source at a
proximal end of the first lumen and the tissue treatment device at
a distal end of the first lumen; the tissue treatment device
forming a first tissue fold and a second tissue fold via a vacuum;
a fastener for fastening the first tissue fold to the second tissue
fold; and an endoscope for real time visualization of the stomach
and tissue treatment device.
44. The delivery system of claim 43, wherein at least a portion of
the elongated member having a plurality of sliding links to
increase flexibility of the elongate member.
45. The delivery system of claim 44, wherein each link has a
substantially cylindrical configuration.
46. The delivery system of claim 45, wherein each link slidingly
engages an adjacent link.
47. The delivery system of claim 44, wherein the plurality of
sliding links are covered with a material to limit trauma to the
esophagus.
48. The delivery system of claim 47, wherein the cover material
includes ployethylene tape, silicone and urethanes.
49. The delivery system of claim 44, wherein the first lumen
extends through the sliding links.
50. The delivery system of claim 43, wherein cables and/or wires
extend through the first lumen.
51. The delivery system of claim 43, wherein the endoscope extends
through the first lumen.
52. The delivery system of claim 43, wherein the elongated member
includes a second lumen extending for at least a portion
therethrough.
53. The delivery system of claim 52, wherein the first lumen and
the second lumen extend side by side.
53. The delivery system of claim 52, wherein the second lumen
slidingly receives the endoscope.
54. The delivery system of claim 43, wherein the elongated member
is formed from a braided material.
55. The delivery system of claim 43, wherein the elongated member
is formed from a molded material.
56. The delivery system of claim 43, wherein the elongated member
is formed from a slotted material.
57. The delivery system of claim 43, wherein the elongated member
is formed from a polymer material.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application is a continuation-in-part of co-pending
application Ser. No. 10/797,303 filed on Mar. 9, 2004, which is
herein incorporated by reference.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention relates generally to medical devices
and methods. More particularly, it relates to devices and methods
for creating a partition within a hollow body organ, particularly a
stomach, intestinal tract, or other region of the gastrointestinal
tract, and affixing the tissue.
[0004] 2. General Background and State of the Art
[0005] In cases of severe obesity, patients may currently undergo
several types of surgery either to tie off or staple portions of
the large or small intestine or stomach, and/or to bypass portions
of the same to reduce the amount of food desired by the patient,
and the amount absorbed by the gastrointestinal tract. The
procedures currently available include laparoscopic banding, where
a device is used to "tie off" or constrict a portion of the
stomach, vertical banded gastroplasty (VBG), or a more invasive
surgical procedure known as a Roux-En-Y gastric bypass to effect
permanent surgical reduction of the stomach's volume and subsequent
bypass of the intestine.
[0006] Typically, these stomach reduction procedures are performed
surgically through an open incision and staples or sutures are
applied externally to the stomach or hollow body organ. Such
procedures can also be performed laparoscopically, through the use
of smaller incisions, or ports, through trocars and other
specialized devices. In the case of laparoscopic banding, an
adjustable band is placed around the proximal section of the
stomach reaching from the lesser curve of the stomach around to the
greater curve, thereby creating a constriction or "waist" in a
vertical manner between the esophagus and the pylorus. During a
VBG, a small pouch (approximately 20 cc in volume) is constructed
by forming a vertical partition from the gastroesophageal junction
to midway down the lesser curvature of the stomach by externally
applying staples, and optionally dividing or resecting a portion of
the stomach, followed by creation of a stoma at the outlet of the
partition to prevent dilation of the outlet channel and restrict
intake. In a Roux-En-Y gastric bypass, the stomach is surgically
divided into a smaller upper pouch connected to the esophageal
inflow, and a lower portion, detached from the upper pouch but
still connected to the intestinal tract for purposes of secreting
digestive juices. A resected portion of the small intestine is then
anastomosed using an end-to-side anastomosis to the upper pouch,
thereby bypassing the majority of the intestine and reducing
absorption of caloric intake and causing rapid "dumping" of highly
caloric or "junk foods."
[0007] Although the outcome of these stomach reduction surgeries
leads to patient weight loss because patients are physically forced
to eat less due to the reduced size of their stomach, several
limitations exist due to the invasiveness of the procedures,
including time, use of general anesthesia, time and pain associated
with the healing of the incisions, and other complications
attendant to major surgery. In addition, these procedures are only
available to a small segment of the obese population (morbid
obesity, Body Mass Index>40) due to their complications, leaving
patients who are considered obese or moderately obese with few, if
any, interventional options.
[0008] In addition to surgical procedures, certain tools exist for
securing tissue such as the stapling devices used in the
above-described surgical procedures and others such as in the
treatment of gastroesophageal reflux disease (GERD). These devices
include the GIA.RTM. device (Gastrointestinal Anastomosis device
manufactured by Ethicon Endosurgery, Inc. and a similar product by
USSC), and certain clamping and stapling devices as described in
U.S. Pat. Nos. 5,403,326; 5,571,116; 5,676,674; 5,897,562;
6,494,888; and 6,506,196 for methods and devices for fundoplication
of the stomach to the esophagus for the treatment of
gastroesophageal reflux disease (GERD). In addition, certain tools,
such as those described in U.S. Pat. Nos. 5,788,715 and 5,947,983,
detail an endoscopic suturing device that is inserted through an
endoscope and placed at the site where the esophagus and the
stomach meet. Vacuum is then applied to acquire the adjacent
tissue, and a series of stitches are placed to create a pleat in
the sphincter to reduce the backflow of acid from the stomach up
through the esophagus. These devices can also be used transorally
for the endoscopic treatment of esophageal varices (dilated blood
vessels within the wall of the esophagus).
[0009] There is a need for improved devices and procedures. In
addition, because of the invasiveness of most of the surgeries used
to treat obesity and other gastric disorders such as GERD, and the
limited success of others, there remains a need for improved
devices and methods for more effective, less invasive hollow organ
restriction procedures.
SUMMARY OF THE INVENTION
[0010] Devices for tissue acquisition and fixation, or
gastroplasty, are described that may be utilized for creating a
partition within a hollow body organ, such as the stomach,
esophageal junction, and other portions of the gastrointestinal
tract. Generally, the devices of the system may be advanced in a
minimally invasive manner within a patient's body, e.g.,
transorally, endoscopically, percutaneously, etc., to create one or
several divisions or plications within the hollow body organ. Such
divisions or plications can form restrictive barriers within the
organ, or can be placed to form a pouch, or gastric lumen, smaller
than the remaining stomach volume to essentially act as the active
stomach such as the pouch resulting from a surgical Roux-En-Y
gastric bypass procedure. Examples of placing and/or creating
divisions or plications may be seen in further detail in U.S. Pat.
No. 6,558,400; U.S. patent application Ser. No. 10/188,547 filed
Jul. 2, 2002; and U.S. patent application Ser. No. 10/417,790 filed
Apr. 16, 2003, each of which is incorporated herein by reference in
its entirety.
[0011] The devices may be advanced within a body through a variety
of methods, e.g., transorally, transanally, endoscopically,
percutaneously, etc., to create one or several divisions or
plications within a hollow body organ, e.g., to create a gastric
lumen or partition to reduce the effective active area of the
stomach (e.g., that which receives the initial food volume),
performed from within the stomach cavity. The creation of this
smaller gastric lumen may be achieved in a minimally invasive
procedure completely from within the stomach cavity. Moreover, the
devices are configured such that once acquisition of the tissue is
accomplished, manipulation of the acquired tissue is unnecessary as
the devices are able to automatically configure the acquired tissue
into a desired configuration.
[0012] The devices may generally comprise a first acquisition
member and a second acquisition member in apposition to one another
along a first longitudinal axis, wherein optionally, at least one
of the acquisition members is adapted to adhere tissue thereto such
that the tissue is positioned between the first and second
acquisition members, and optionally wherein at least one of the
acquisition members is movable relative to the first longitudinal
axis between a delivery configuration and a deployment
configuration. Moreover, the system may also comprise a septum, or
separator, removably positioned between the first and second
acquisition members, wherein at least one of the acquisition
members is movable relative to the septum between a delivery
configuration and a deployment configuration.
[0013] A handle may be located at a proximal end of an elongate
body or member and used to manipulate the device advanced within
the hollow body organ as well as control the opening and clamping
of the acquisition members onto the tissue. The elongate body may
be comprised of a series of links, or of an extrusion fabricated
with various lumens to accommodate the various control mechanisms
of the acquisition device. Similarly, the control mechanisms may be
grouped together and sheathed in a thin skin sheath, such as a heat
shrink. A working lumen may extend entirely through the elongate
member and may be sized to provide access to the distal end for
various surgical tools, such as an endoscope or other visualization
device, or therapeutic devices such as snares, excisional tools,
biopsy tools, etc. once the distal end of the assembly is
positioned within the hollow body organ. The acquisition members
may be joined to the elongate body via a passive or active hinge
member, adaptable to position the assembly. The acquisition members
may generally comprise a cartridge member placed longitudinally in
apposition to an anvil member. The cartridge member may contain one
or several fasteners, e.g., staples, clips, etc., which may be
actuated via controls located proximally on the handle assembly.
Moreover, the septum or barrier may be removably positioned between
the cartridge member and anvil member and used to minimize or
eliminate cross acquisition of the tissue into the cartridge member
and/or anvil member.
[0014] Methods of placing a partition from within a hollow body
organ using the devices disclosed herein generally comprise
positioning a first acquisition member and a second acquisition
member adjacent to a region of tissue within the hollow body organ,
wherein the first and second acquisition members are in apposition
to one another along a first longitudinal axis, adhering tissue
from the region to each of the first and second acquisition
members, and securing the adhered tissue between the first and
second acquisition members. Such a method may also involve pivoting
at least one of the acquisition members about the longitudinal axis
to an open or closed configuration. Another method may also
comprise removing a septum from between the first acquisition
member and the second acquisition member.
[0015] While the device is in a delivery configuration, i.e., where
the components of the distal working portion of the device (the
cartridge member and anvil member) are disposed such that the
cartridge and anvil are directly positioned into apposition about
the septum. Once desirably positioned, one or both of the cartridge
member and anvil member may be rotated about a pivot or
translationally moved in parallel to one another. Then, portions of
the stomach wall may be acquired by, or drawn within their
respective openings. The configuration of the cartridge member and
anvil member and the positioning of the device within the stomach
are such that this tissue acquisition procedure also enables the
devices to be self-adjusting with respect to the acquired tissue.
Moreover, the devices are configured such that portions of the
stomach wall are automatically positioned for fixation upon being
acquired and the tissue becomes automatically adjusted or tensioned
around the perimeter of the distal working portion of the device in
the stomach and within the distal working portion inner volume, to
achieve the desired resulting geometry (e.g., small gastric pouch
or restrictive partition or baffle). Because of the manner in which
the tissue is acquired, the tissue intimately surrounds the
cartridge member and anvil member to define or calibrate the
subsequent volume of the resulting gastric lumen. Thus, the gastric
volume may be predetermined by adjusting the volume of the
cartridge member and anvil member, or the use of accessory devices
such as a scope or balloon. As a result, once the desired volume is
known and incorporated in the device, the user can achieve a
controlled acquisition and without intraprocedural adjustments or
positioning requirements.
[0016] The septum may act effectively as a barrier between the
openings to facilitate the acquisition of the tissue to their
respective openings while minimizing or eliminating cross
acquisition of the tissue into the cartridge member and/or anvil
member. In other alternatives, the septum may be omitted from the
device and acquisition of the tissue may be accomplished by
sequentially activating vacuum forces within the openings. Once the
tissue has been acquired, the septum may be removed from between
the cartridge member and anvil member by translating the septum
distally or proximally of the cartridge member and anvil member or
left within the stomach for later removal.
[0017] The cartridge member of the tissue treatment device may be
re-loadable with a removable staple cartridge after forming a
plication within the cavity. This allows the same tissue treatment
device to form multiple plications within the cavity. A method of
treating a stomach cavity may include forming a first plication
within the stomach cavity using staples from a first removable
staple cartridge, which is easily removed from the cartridge
member. A second removable staple cartridge is then inserted into
the cartridge member, and a second plication is formed within the
stomach cavity using staples from the second removable staple
cartridge.
[0018] Another method of forming a plication within the stomach
cavity may include clamping the cartridge member and the anvil
member together twice before firing staples into acquired tissue.
This method helps to ensure that the desired tissue is acquired by
the tissue treatment device, and that there are not folds or pleats
present in the acquired tissue. After inserting the tissue
treatment device transorally to the stomach cavity, stomach tissue
is acquired at a target region for treatment with the tissue
treatment device. The cartridge member and anvil member of the
tissue treatment device are then clamped together grasping the
acquired target tissue, and the stomach cavity can be insufflated
to inspect the acquired target tissue. If the inspection reveals
that the tissue acquired is not the targeted tissue or that there
are folds or pleats within the acquired tissue, the acquired tissue
can be released from the tissue treatment device and re-acquired.
If the inspection reveals the acquired tissue would form a desired
sleeve, then the stomach cavity can be desufflated once again, and
the cartridge member and the anvil member can be unclamped into an
open configuration, to fully acquire the tissue. The tissue
treatment device may include a barrier such as a septum, in which
case the barrier would be removed from between the cartridge member
and the anvil member. After which, the cartridge member and anvil
member are clamped together a second time and the stomach cavity is
again insufflated to inspect the acquired tissue. If the inspection
reveals a desired formation between the folds of acquired tissue,
the cartridge member and anvil member are fully clamped together
and the acquired tissue is plicated to form a gastric sleeve within
the stomach cavity.
BRIEF DESCRIPTION OF THE DRAWINGS
[0019] FIGS. 1A and 1B show side and detailed side views,
respectively, of one variation of an exemplary gastroplasty device
described herein.
[0020] FIGS. 2A and 2B show perspective detailed views of an
exemplary gastroplasty device described herein.
[0021] FIGS. 3A and 3B show perspective and end views,
respectively, of a cross-sectioned portion of an exemplary
gastroplasty device.
[0022] FIGS. 4A and 4B show representative illustrations of how a
gastroplasty device may be advanced transorally through the
esophagus of a patient and positioned within the stomach cavity of
a stomach.
[0023] FIGS. 5A to 5D show end views of an example of how an
exemplary gastroplasty device may be used to acquire and fasten
tissue within a hollow body organ.
[0024] FIG. 5E illustrates a resulting fastened gastric lumen that
may be formed using the gastroplasty devices described herein.
[0025] FIGS. 5F and 5G demonstrate how a distal working portion of
a gastroplasty device, and an inner volume, respectively, help to
define the final configuration of the acquired tissue.
[0026] FIGS. 5H and 5I show perspective and cross sectional views
of illustrative tissue configurations that may be formed with the
gastroplasty devices and methods described herein.
[0027] FIGS. 6A and 6B show perspective and end views,
respectively, of one variation of a gastroplasty device, wherein
the septum is in position.
[0028] FIGS. 7A and 7B show perspective and end views,
respectively, of the device of FIG. 6A in an open
configuration.
[0029] FIGS. 8A and 8B show perspective and end views,
respectively, of the device of FIG. 6A in an open configuration
with the septum removed.
[0030] FIGS. 9A and 9B show perspective and end views,
respectively, of the device of FIG. 6A in a closed
configuration.
[0031] FIGS. 10A to 10C show end views of the cartridge member and
anvil member during delivery, during tissue acquisition, and prior
to clamping of the tissue, respectively, in one example of how a
clamping cable may be routed with respect to an optional
septum.
[0032] FIGS. 11A and 11B show perspective and end views,
respectively, of another variation of a suitable gastroplasty
device.
[0033] FIGS. 11C and 11D show perspective views of a gastroplasty
device with and without a septum, respectively.
[0034] FIGS. 12A to 12C show perspective views of yet another
variation of a gastroplasty device.
[0035] FIGS. 13A and 13B show cross-sectioned perspective and end
views, respectively, of alternative acquisition pod assembly.
[0036] FIGS. 13C and 13D show cross-sectioned perspective and end
views, respectively, of the device of FIGS. 13A and 13B under a
high vacuum pressure.
[0037] FIGS. 14A to 14D show perspective views of the operation of
another variation of a gastroplasty device utilizing parallel pod
motion.
[0038] FIG. 14E shows a cross-sectional perspective view of a
portion of the pod members in an open configuration with a septum
still in place between the cartridge member and anvil member.
[0039] FIG. 15 shows a perspective view of yet another variation of
a gastroplasty device utilizing a translational trolley plate.
[0040] FIGS. 16A to 16D show side, end, bottom, and perspective
views, respectively, of a variation of a gastroplasty device, which
utilizes a static acquisition pod.
[0041] FIG. 16E shows a bottom view of one variation of a
gastroplasty device having an arcuate configuration.
[0042] FIG. 17 shows a perspective view of a device having an
optional feature of projections or serrations which may be defined
along the mating surfaces of the cartridge member and/or anvil
member.
[0043] FIGS. 18A and 18B show perspective and cross-sectional end
views, respectively, of another optional feature of one or more
rotatable shafts which may be integrated into the device.
[0044] FIGS. 19A and 19B show perspective and detailed perspective
views, respectively, of a device having a curved or adjustable
segmented staple cartridge.
[0045] FIGS. 20A and 20B show perspective views of a septum
assembly having a tapered edge for facilitating removal of the
septum from the hollow body organ.
[0046] FIGS. 21A and 21B show perspective views of an alternative
septum assembly having ribbed surfaces.
[0047] FIG. 21C shows a side view of one example of how collapse of
the septum may be facilitated by withdrawing the septum into a
receiving member.
[0048] FIGS. 22A and 22B show perspective and end views,
respectively, of a septum variation having at least two transverse
septum members extending to opposite sides of the longitudinal
septum member.
[0049] FIG. 23A illustrates an end view of an extendable septum
assembly positioned between pod members and placed against stomach
tissue.
[0050] FIGS. 23B and 23C show side views of variations for
extending the septum assembly from a low profile delivery to an
extended deployed configuration.
[0051] FIGS. 24A and 24B show end views of an alternative septum
assembly which may be configured to deploy an extendable septum
from a rolled-up configuration.
[0052] FIGS. 25A and 25B show perspective views of an alternative
septum assembly having a collapsible septum member.
[0053] FIGS. 25C and 25D show end views of the septum of FIG. 25A
in an expanded or extended configuration and in a collapsed
configuration.
[0054] FIGS. 26A to 26C show end, bottom, and perspective views,
respectively, of yet another alternative septum having radiused
corners.
[0055] FIGS. 27A and 27B show perspective views of an alternative
septum assembly having a low profile delivery configuration where
the septum may be comprised of two elongate T-shaped members.
[0056] FIGS. 28A to 28C show perspective views of an example of a
clamping mechanism having two cam members.
[0057] FIG. 29A shows a perspective view of one example of how
clamping cables may be routed through a gastroplasty device
described herein.
[0058] FIG. 29B shows a cross-sectioned end view of a parallel
clamping device with the septum shown.
[0059] FIGS. 30A and 30B show side and edge views of an alternative
gastroplasty device, utilizing linked pod members.
[0060] FIG. 31 shows a perspective view of another variation of a
gastroplasty assembly.
[0061] FIG. 32 shows a perspective view of sliding links joined
together that form an elongated tubular member for the gastroplasy
assembly.
[0062] FIG. 33 shows a cross-sectional view taken along line 33-33
of FIG. 32.
[0063] FIG. 34 shows a variation of a tissue treatment device of a
gastroplasty assembly in a delivery configuration with an endoscope
alongside.
[0064] FIG. 35 shows the tissue treatment device of FIG. 34 with
jaws opened.
[0065] FIG. 36 shows the tissue treatment device of FIG. 35 with
the jaws opened and a retractor wire and sail in an extended
configuration.
[0066] FIG. 37 shows a backside perspective view of the tissue
treatment device of FIG. 36.
[0067] FIG. 38 shows a variation of a basket that may be disposed
within a vacuum pod of the tissue treatment device.
[0068] FIG. 39 shows a perspective view of a removable staple
cartridge.
[0069] FIG. 40 shows a perspective view of the removable staple
cartridge positioned within a cartridge member of the tissue
treatment device.
[0070] FIG. 41 shows a partial cross-sectional side elevational
view of the removable staple cartridge positioned within the
cartridge member of the tissue treatment device.
[0071] FIG. 42 shows a planar view of an end ring that is connected
to a distal end of the flexible elongated member.
[0072] FIG. 43 shows a partial cross-sectional view of the tissue
treatment device in a closed position.
[0073] FIG. 44 shows a partial cross-sectional view of the tissue
treatment device in an open position.
[0074] FIG. 45 shows a perspective view of a handle assembly.
[0075] FIG. 46 shows a partial cross-sectional view of the handle
assembly shown in FIG. 45.
[0076] FIGS. 46A and 46B show a push/pull mechanism disposed within
the handle assembly.
[0077] FIGS. 47 through 53A show illustrative views and
cross-sectional views of one method of forming a gastric sleeve in
a stomach cavity.
[0078] FIG. 54 shows a perspective view of a variation of a stapler
restrictor.
[0079] FIG. 54A shows a stapler assembly of the stapler restrictor
in a closed configuration.
[0080] FIG. 54B shows the stapler assembly of the stapler
restrictor in an open configuration.
[0081] FIG. 54C shows the stapler assembly of the stapler
restrictor with a rubber tip and removable staple cartridge
removed.
[0082] FIG. 54D shows the stapler assembly of the stapler
restrictor with an anvil member removed.
[0083] FIG. 54E shows the removable staple cartridge and rubber tip
being loaded into a cartridge member the stapler assembly.
[0084] FIGS. 55 through 57A show cross-sectional views of one
method of forming a single fold of tissue near a distal stoma of a
gastric sleeve to narrow the distal stoma.
[0085] FIG. 58 shows a cross-sectional view of a gastric sleeve
formed with one dual fold plication and restricted with three
single fold plications.
[0086] FIG. 59 shows an illustration of a stomach cavity with two
dual fold plications forming a long sleeve and two single fold
plications along the lesser curve to narrow the gastric sleeve.
[0087] FIG. 60 shows an illustration of a stomach cavity with three
dual fold plications forming a long sleeve and three single fold
plications along the lesser curve to narrow the gastric sleeve.
[0088] FIG. 61 shows an illustration of a stomach cavity with four
dual fold plications forming a long sleeve from the
gastroesophageal junction to the pylorus.
[0089] FIGS. 62 through 65 show another embodiment of a tissue
treatment device having a distal clamping wire passed around a
distal vertical pulley.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0090] Gastroplasty devices for tissue acquisition and fixation,
and methods of using them are described. In general, the
gastroplasty devices described herein may be utilized for creating
a partition within a hollow body organ, such as the stomach,
esophageal junction, and/or other portions of the gastrointestinal
tract. The gastroplasty devices may be advanced within a body
through a variety of methods, e.g., transorally, transanally,
endoscopically, percutaneously, etc., to create one or several
divisions or plications within the hollow body organ, e.g., to
create a gastric lumen within the stomach. Further, the
gastroplasty devices may be assisted through the use of
laparoscopic guidance, in particular, visualization of the external
surface of the hollow body organ to assist in placement of the
device, or within the organ cavity to monitor the procedure.
Similarly, the devices of the present invention may be used in
conjunction with other laparoscopic procedures, or may further be
modified by an additional step or procedure to enhance the geometry
of the partition. For example, upon placement of a partition of the
present invention, it may be desirable to perform a secondary step
either transorally, or laparoscopically, to achieve the desired
gastroplasty geometry, such as the placement of a single fold or
plication within the gastric lumen or pouch as described in U.S.
patent application Ser. No. 10/188,547, which was filed Jul. 2,
2002 and is incorporated by reference herein in its entirety, to
further restrict the movement of food through the pouch, or the
laparoscopic placement of a band, clip, ring or other hollow
reinforcement member at the outlet of the gastric lumen such as is
done in a VBG, or lap-band procedure to reinforce or narrow the
outlet of the lumen.
[0091] The gastroplasty devices described here, allow for the
creation of a smaller gastric lumen to be achieved in a minimally
invasive surgical procedure completely from within the stomach
cavity. Moreover, the devices described herein are configured such
that once acquisition of the tissue is accomplished, any
manipulation of the acquired tissue is unnecessary as the devices
are able to automatically configure the acquired tissue into a
desired configuration whereby the geometry of the devices regulates
or prescribes the resulting tissue geometry at the time of
acquisition. In operation, the perimeter of the device, and any
openings therein, form the template or mold cavity around and into
which tissue flows, thereby creating a tissue structure that
reflects the geometry of the mold. That is, as the devices are
configured such that portions of the stomach wall are automatically
positioned for fixation upon being acquired, and the tissue becomes
automatically adjusted or tensioned around the perimeter of the
distal working portion of the device in the stomach and within the
distal working portion inner volume, to achieve the desired
resulting geometry (e.g., small gastric pouch or restrictive
partition or baffle). Because of the manner in which the tissue is
acquired, the tissue intimately surrounds the cartridge member and
anvil member to define or calibrate the subsequent volume of the
resulting gastric lumen. Thus, the gastric volume may be
predetermined by adjusting the volume of the cartridge member and
anvil member. As a result, once the desired volume is known and
incorporated in the device, the user can achieve a controlled
acquisition and without intraprocedural adjustments or positioning
requirements. Subsequent manipulation of the tissue may be
performed, if desired, to effect certain configurations; however,
this manipulation may be omitted entirely.
[0092] Turning to the figures, FIG. 1A shows a side view of one
variation of gastroplasty assembly 10. Assembly 10 may be generally
comprised of an elongate tubular member 12 having handle assembly
16 connected at a proximal end 14. An integrated access assembly 18
may also be connected at proximal end 14 for providing access to
working lumen 22 defined within elongate member 12. Elongate member
12 may have a circular or elliptical cross-sectional area.
Alternatively, the cross-sectional area may take on any number of
different cross-sectional configurations, e.g., hexagonal,
octagonal, etc., provided that it presents an atraumatic surface to
the tissue surfaces within the body. In addition, elongate member
12 may be curved, or may comprise a series of links as described in
U.S. patent application Ser. No. 10/686,326, which was filed on
Oct. 14, 2003, and is incorporated by reference in its entirety
herein. In this way, a curved or flexible elongate member, or an
elongate member comprising a series of links will help to increase
the flexibility of the elongate member, and hence increase the ease
in which the device is handled and operated. Working lumen 22 may
extend entirely through tubular member 12 and may be sized to
provide access to distal end 20 for various surgical tools or
therapies once distal end 20 of assembly 10 is positioned within a
hollow body organ, and in particular may be useful to place an
endoscope or other visualization tool. Alternatively, a fiberscope
or other type of visualization tool may be integrated within the
elongate member. Examples of useful scopes may be the Olympus GIF
P140, the Fujinon EG 25PE, and the like. Gastroplasty device 24 is
typically positioned at the distal end of tubular member 12 and is
also generally configured to be advanced atraumatically through the
body of a patient and within a hollow body organ, e.g., esophagus,
stomach, etc. Alternatively, an optional separate thin walled
oversheath, may also be placed over the acquisition device,
including the elongate member, to assist in placement, or may be
placed over a guidewire or obturator down the esophagus prior to
placement of the gastroplasty device and removed with the
gastroplasty device once the procedure is complete. The liner may
be made of a thin wall polymer such as polyolefin,
polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE), silicone and
the like, having a wall thickness between 0.004'' and 0.025''. This
liner can serve to guide the gastroplasty device, as well as help
to limit trauma to the esophagus and other delicate structures.
[0093] FIG. 1B shows a closer detail view of the gastroplasty
assembly 10. As shown there, the device comprises a distal working
portion, which comprises a cartridge member or pod 26 placed
longitudinally in apposition to anvil member or pod 28. As
described above, when the device is in use, the tissue of the
stomach wall (including, in some instances, the muscular tissue
layers) are adjusted or tensioned around the perimeter of the
distal working portion, and within the distal working portion inner
volume, to achieve a desired resulting geometry (e.g., small
gastric pouch or restrictive partition or baffle). Thus, the
gastric volume may be predetermined by adjusting the volume of the
distal working portion, inner or outer profile. Cartridge member 26
may contain one or several fasteners, e.g., staples, clips, etc.,
which may be actuated via controls located proximally on handle
assembly 16. A septum or barrier 32, described in further detail
below, may be removably positioned between cartridge member 26 and
anvil member 28 while connection member 30 may connect device 24 to
tubular member 12.
[0094] Handle assembly 16 may be variously configured depending
upon the desired functionality to be implemented on assembly 10. In
this variation, handle assembly 16 may generally comprise handle 34
for use by the surgeon or physician in advancing, withdrawing, or
articulating assembly 10. A control for articulating the device 24
between an open and closed configuration may be located on handle
34, shown as clamping control knob 36, while a separate control
mechanism, shown here as fastener firing lever 38, may be utilized
for deploying the fasteners located within cartridge member 28.
Although specific types of controls are shown, these are intended
only to be illustrative of the types of control mechanisms which
may be utilized and are not intended to be limiting in scope.
[0095] Assembly 10 may further have one or several integrated
vacuum ports 40 proximally located on elongate member 12 for fluid
connection to one or several vacuum pumps (not shown). One or each
of cartridge 26 or anvil 28 members may be fluidly connected
through a common tube 12 or channel or through individually
corresponding tubes or channels through elongate member 12 to
vacuum ports 40. Additionally, a scope seal housing 42 configured
to provide access to the working lumen 22 may also be optionally
provided near or at the proximal end of elongate member 12 for the
insertion of various tools and devices through elongate member 12
for accessing the distal end of the assembly 10. An optional
auxiliary port 44 may also be provided for allowing fluid
communication via a channel or tubing through elongate member 12
between the proximal and distal ends of the assembly 10. Auxiliary
port 44 maybe utilized for various purposes, e.g., delivery of
fluids or gases into the hollow body organ for transporting drugs
or providing insufflation, etc. As noted above, the elongate body
may be comprised of a series of links, similar to those described
in U.S. patent application Ser. No. 10/686,326, or of an extrusion
fabricated with various lumens to accommodate the various control
wire and mechanisms of the acquisition device. Similarly, the
control mechanisms may be grouped together with a flexible band,
and then sheathed in a thin skin sheath, such as heat shrink. The
elongate member may also be a combination of an extrusion and a
thin wall sheath to allow for flexibility, and may utilize braided
materials, e.g., stainless steel or superelastic materials such as
Nickel-Titanium alloy, integrated in the wall of the sheath to
prevent kinking and enhance torqueability.
[0096] A detailed view of one variation of the gastroplasty devices
described herein is shown in the perspective view of FIG. 2A. The
cartridge member 26 and anvil member 28, as described above, may
extend longitudinally from the distal end of elongate member 12 via
connection member 30. The cartridge member 26 and anvil member 28
may be both or singularly articulatable relative to one another or
relative to elongate member 12. A pivot 50 longitudinally
positioned between cartridge member 26 and anvil member 28 may be
configured to enable the device to be pivoted into an open
configuration for the acquisition of tissue and a closed or
deployment configuration for delivery or advancement of the device
into the hollow body organ.
[0097] If both members 26,28 are articulatable, they may be
configured to be either simultaneously or sequentially
articulatable. The cartridge member 26 may contain a cartridge 52
container fasteners along an outer edge of the member 26 while the
anvil member 28 may have an anvil positioned along an outer edge of
the member 26 such that the anvil corresponds to the number and
position of fasteners within cartridge 52. One or both members
26,28 may also define openings 56,58, respectively, along a portion
of the length or the entire length of each of the members 26,28.
One or both of these openings 56,58 may be connected via tubing
through vacuum lumens 60,62, respectively, defined through elongate
member 12 to the vacuum ports 40 located at the proximal end of
member 12. Alternatively, a central vacuum lumen may supply both
ports, or may bifurcate at the proximal or distal end of member 12.
Elongate member 12 may also define various cable lumens 64,66 for
the passage of cables for controlling the opening and closing of
members 26,28 as well as additional cable lumen 68 for the passage
of cables for actuating deployment of the fasteners from within
cartridge 52. Moreover, cable lumen 70 may be used for the passage
of cables used for controlling the clamping of the members 26,28
towards one another.
[0098] Each of the members 26,28 may have openings 72,74 and 76,78,
respectively, defined at the outer corners of each member opposite
pivot 50 to allow for the routing and passage of clamping cables
through the device for enabling cartridge member 26 and anvil
member 28 to be clamped closed towards one another. FIG. 2B shows a
perspective view of the acquisition and fixation device of FIG. 2A
with the vacuum tubing and cables routed through the device. As
shown, vacuum tubing 80,82 may be routed through elongate member 12
into a proximal end of one or each of cartridge member 26 and/or
anvil member 28 for fluid connection with respective openings
56,58. Cables 84,86 may be utilized for opening and closing the
cartridge member 26 and anvil member 28 and cable 88, which may be
routed into cartridge member 26, may be positioned and utilized,
e.g., for pulling or pushing a wedge mechanism, to deploy fasteners
out of cartridge 52. Moreover, clamping cables 90 may be passed
through elongate member 12 and routed through cartridge member 26
and anvil member 28 such that cables 92,94 are passed through
openings 72,74 and 76,78 for clamping cartridge member 26 and anvil
member 28 closed. Cables 84 and 86 may be replaced by torque shafts
connected to handles at the proximal end of the device, to open and
close the cartridge and anvil members.
[0099] FIGS. 3A and 3B show perspective and end views,
respectively, of a cross-sectioned portion 100 of a suitable
gastroplasty device. As may be seen, septum 32 may be positioned to
extend from pivot 50 effectively separating vacuum openings 56,58
within cartridge member 26 and anvil member 28, respectively.
Adjacent to opening 56 is fastener cartridge 52 and adjacent to
opening 58 is anvil 54 positioned such that when septum 32 is
removed or displaced, the articulation of cartridge member 26 and
anvil member 28 towards one another about pivot 50 positions
cartridge 52 in apposition to anvil 54. Alternatively, anvil member
28 cartridge member 26 may be nonmovable or in a fixed position
relative to the longitudinal axis of the device. In this
configuration, fastener cartridge 52 and optionally anvil 54, may
be actuated to eject from their respective housings to fasten the
acquired tissue.
[0100] FIGS. 4A and 4B show representative illustrations of how
gastroplasty device 24 may be advanced transorally through the
esophagus ES of a patient and positioned within stomach cavity SC
of stomach 110. Making reference now to FIG. 4A, device 24 may be
articulated outside the patient via handle 16 so that the proximal
portion of elongate member 12 may be positioned such that the spine
of the device is placed against a portion of lesser curvature LC
and opposite greater curvature GC. In this way, the device 24
extends between the gastroesophageal junction GEJ towards pylorus
PY. In addition FIG. 4A depicts the use of a flexible endoscope EN
alongside the device 10 to allow direct visualization of the
procedure, including the fixation step whereby the scope can then
be removed, leaving additional volume remaining in the smaller
gastric pouch that may be helpful when removing or detaching the
gastroplasty device 24 from the acquired tissue once it has been
fixed. If no direct visualization is required, but additional
removal volume is desired, an optional expandable balloon, or other
expandable member EM may be used alongside the spine of the
gastroplasty device, or may be integrated into the spine of the
gastroplasty device using known techniques. FIG. 4B shows the
positioning of gastroplasty device 10 without the aid of an
endoscope, or other direct visualization technique.
[0101] FIG. 5A shows an end view of device 24 positioned within
stomach cavity SC with pivot 50 placed against stomach wall 120,
for instance, against lesser curvature LC in one example of how the
device 10 may be used to effect the creation of a gastric lumen or
partition within stomach cavity SC. The device is advanced through
the esophagus ES while in a deployment configuration, i.e., where
the distal working portion of the device DWP is configured so that
cartridge member 26 and anvil member 28 are closed such that
openings 56,58 and cartridge 52 and anvil 54 are directly
positioned in apposition about septum 32. When desirably
positioned, one or both of cartridge member 26 and anvil member 28
may be rotated about pivot 50 in the direction of the arrows shown.
FIG. 5B shows cartridge member 26 and anvil member 28 rotated at an
angle with a vacuum force activated within openings 56,58. In
certain embodiments where no pivoting or movement of the cartridge
member 26 or anvil member 28 is necessary, the device is advanced
in a static state. As seen, portions of the stomach wall 120 may be
acquired and drawn within respective openings 56,58. The
configuration of cartridge member 26 and anvil member 28 and the
positioning of the device 24 within stomach cavity SC are such that
this tissue acquisition procedure also enables the device 24 to be
self-adjusting with respect to the acquired tissue 122,124. More
particularly, the device 24 is configured such that portions of the
stomach wall 120 are automatically positioned for fixation upon
being acquired and the device 24 becomes automatically adjusted
within stomach cavity SC relative to the stomach wall 120.
Furthermore, because of the manner in which the tissue is acquired,
the tissue intimately surrounds the cartridge member 26 and anvil
member 28, i.e., the distal working portion of the device DWP, by
being tensioned or held around the perimeter PT of the distal
working portion of the device and within the inner volume IV of the
distal working portion of the device to define the subsequent
volume or resulting geometry RG resulting gastric lumen as shown by
the diagonal and hatched lines respectively in FIGS. 5F and 5G. An
illustrative depiction of a cross section of a resulting tissue
geometry is provided in FIG. 5E. Other depictions of resulting
tissue geometries are provided in FIGS. 5H and 51. Shown there are
front views of the distal working portion of the device, and cross
sectional views (along lines A-A and B-B respectively) of the
resulting tissue geometries. In FIG. 5H, the distal working portion
has been configured to provide one plication P, whereas in FIG. 5I,
the distal working portion has been configured to provide more than
one plication. Multiple plications may be useful, for example, to
help increase the ease in which the distal working portion of the
device is removed from a patient after tissue has been acquired and
fixed. Thus, as these FIGS. illustrate, the gastric volume may be
predetermined by adjusting the volume of the cartridge member 26
and anvil member 28, or geometry of the distal working portion of
the device, e.g., the distal working portion of the device may be
configured so that the gastric tissue has results in the geometries
described, for example, in U.S. patent application Ser. No.
10/417,790, which was filed on Apr. 16, 2003 and is hereby
incorporated by reference in its entirety.
[0102] Optional septum 32 may act effectively as a barrier between
openings 56,58 to facilitate the acquisition of the tissue 122,124
into their respective openings 56,58 while minimizing or
eliminating cross acquisition of the tissue into cartridge member
26 and/or anvil member 28. In another alternative, septum 32 may be
omitted from the device 24 and acquisition of the tissue may be
accomplished by sequentially activating vacuum forces within
openings 56 and 58. That is, the cartridge and anvil members may be
orient towards the tissue surface in a sequential fashion,
acquiring the tissue adjacent thereto. However, when a septum is
employed, it may be removed from between cartridge member 26 and
anvil member 28 by translating the septum 32 distally, laterally,
or proximally of cartridge member 26 and anvil member 28, after the
tissue has been acquired. Alternatively, the septum may be left
within stomach cavity SC for later removal, or as will be described
in more detail below, may be left within the stomach cavity to
biodegrade. FIG. 5C shows septum 32 having been removed so that
cartridge member 26 and anvil member 28 may be pivoted from the
open configuration back to its closed configuration in the
direction of the arrows shown. Because the septum 32 has been
removed, tissue region 126 may now be presented for clamping
between cartridge 52 and anvil 54.
[0103] As shown in FIG. 5D, cartridge member 26 and anvil member 28
may be simply clamped over tissue region 126 and fastened by
deploying one or several fasteners from within cartridge 52. In
acquiring the tissue 122,124, manipulation of the tissue region 126
or the acquired tissue 122,124 may be eliminated entirely due to
the automatic positioning of the tissue for fastening. Once the
clamped tissue has been fastened, the device 24 may be withdrawn
entirely from the stomach cavity SC, as shown in FIG. 5E. As seen,
one or several fasteners 128, e.g., a line of staples, may hold the
tissue in its fastened configuration to result in the creation of a
partition, creating a restriction, or when desired, creating a
gastric lumen or pouch 130, separate from the remainder of the
stomach cavity.
[0104] Alternative variations of gastroplasty device 24 may also be
utilized. For instance, FIG. 6A shows a perspective view of another
variation in device 140 partly cross-sectioned for the sake of
clarity. In this variation, cartridge member 142 and anvil member
144 may define a curved or arcuate shape. The septum may also be
configured to have a longitudinal barrier portion 146 with a first
transverse barrier 152 and a second optional transverse barrier
154. One or both barriers 152,154 may extend in a curved or arcuate
shape from the longitudinal septum 146 such that an atraumatic
surface is presented to tissue during advancement within the
patient. The septum may be retained between cartridge member 142
and anvil member 144 via septum detent 148 being slidably
positioned within septum retaining channel 150, which extends
longitudinally between cartridge member 142 and anvil member 144.
Longitudinal septum 146 may partition openings 156,158, which may
function in the same manner as described above for adhering tissue.
It may be advantageous to house a pressure transducer 159 near or
within the pod(s) or opening(s), to allow the device user to
accurately gauge measurement of pressure at the site of tissue
adhesion. A drop of pressure within the pod or opening signals to
the user that the vacuum seal has been compromised, and therefore
the amount of tissue adhered to the system is not optimal. Readings
from the transducer can serve as feedback to the user that
sufficient vacuum pressure has been maintained, and therefore be a
"go-nogo" trigger to the user. FIG. 6B shows a cross-sectional end
view of the variation 140 from FIG. 6A. As illustrated, cartridge
162 may retain one or several fasteners 166, shown in this
variation as staples, in corresponding apposition to anvil 164 when
cartridge member 142 and anvil member 144 are in the closed or
delivery configuration. It should be noted that while a rectangular
staple jaw is depicted, it may be desirable to provide a curved
track or wedge to facilitate the placement of a curved line of
staples, from the rectangular jaw. Pivoting member or plate 168,
which may function to facilitate the pivoting the device, may be
seen as placed over the outer surface of cartridge member 142 and
anvil member 144.
[0105] FIG. 7A shows a perspective view of an open configuration
170 of the device of FIGS. 61 and 6B for receiving tissue within
openings 156,158. Septum 146 may be removed from the device by
translating the septum 146 longitudinally in the direction of the
arrow. As shown in the end view in FIG. 7B, pivoting region 160 may
be seen expanded via pivoting plate 168, which may be made from
various biocompatible materials, e.g., stainless steel, polymers,
etc., and which is sufficiently flexible to enable the device to
transition between the open and closed configurations. FIG. 8A
shows the open configuration 180 in which the septum 146 has been
removed from the device. As described above, the septum may be
removed once the tissue has been acquired within their respective
openings. FIG. 8B shows an end view of the device with the septum
removed. The tissue acquired within open region 182 may be clamped
by articulating cartridge member 142 and anvil member 144 in the
direction of the arrows to result in the configuration shown in
FIG. 9A, which shows the device 190 ready for fastening the clamped
tissue within clamping region 192. FIG. 9B shows an end view of the
device configured into its closed configuration for fastening the
tissue within clamping region 192. As described above, because the
stomach tissue may be automatically configured for fastening once
the tissue has been acquired, manipulation of the tissue is
rendered unnecessary during clamping and fastening of the
tissue.
[0106] In facilitating the clamping of cartridge member 142 and
anvil member 144 onto the tissue, clamping cables may be utilized,
as described above. FIGS. 10A to 10C show end views of cartridge
member 142 and anvil member 144 during delivery, during tissue
acquisition, and prior to clamping of the tissue, respectively, and
one example of how clamping cable 200 may be routed with respect to
septum 146. FIG. 10A shows septum 146 in position between cartridge
member 142 and anvil member 144 with clamping cable 200 routed
within a cable constraining slot 202 defined in an adjacent portion
of septum 146. The clamping cable 200 may extend between cartridge
member 142 and anvil member 144 through clamping cable openings 204
defined in both cartridge member 142 and anvil member 144. Once the
septum 146 is removed, as shown in FIG. 10C, the clamping cable 200
may be released from slot 202 and tensioned to bring cartridge
member 142 and anvil member 144 towards one another, as described
in further detail below. Other mechanisms of clamping are also
suitable, for example, the tissue may be clamped using hydraulic,
pneumatic, or electropneumatic mechanisms, all of which are well
known in the art.
[0107] FIGS. 11A and 11B shows perspective and end view of another
alternative gastroplasty device 210. This variation shows cartridge
member 212 and anvil member 214 in a closed configuration with
extension member 218 connected to longitudinal pivot 216. The
septum, in this variation, may comprise a longitudinal septum
member 220 and a perpendicularly positioned transverse septum
member 222, which may extend partially over the openings 228, 230
when cartridge member 212 and anvil member 214 are in an open
configuration, as shown in FIG. 1 IC. Respective vacuum tubing
224,226 may be fluidly connected to one or both openings 228,230
defined within their respective members 212,214. FIG. 11D
illustrates the device with the septum translated distally showing
a clearer view of opening 230.
[0108] FIGS. 12A to 12C show perspective views of yet another
variation of gastroplasty device 240. In this variation, cartridge
member 242 and anvil member 244 may be pivotally connected via
longitudinally defined pivot 246. Similar to the variation of FIGS.
11A and 11B, the septum may also comprise a longitudinal septum
member 248 positionable between members 242,244 and an optional
perpendicularly configured transverse septum member 250. Also seen
are vacuum tubing 252,254 fluidly coupled to their respective
openings 260,262. As discussed above, because the resulting gastric
lumen may be defined by the shape and volume of the device,
cartridge member 242 and anvil member 244 may each define tapered
distal ends 256,258, respectively, to provide an atraumatic surface
for advancement within the patient and to facilitate formation of a
gastric lumen having a tapered distal region. The proximal shoulder
of the members may also be tapered to facilitate removal of the
device once the procedure has been completed. Moreover, this
variation also shows openings 260,262 which may be elongated to
extend over a majority of the length of their respective members
244,242.
[0109] Yet another variation of an alternative acquisition pod
assembly 270 is shown in the cross-sectioned perspective view of
FIG. 13A. This variation may generally comprise pod walls 272,274
each defining an undercut section 276,278 having projections or
serrations 280,282 along their edges directed or angled towards one
another. The assembly 270 may be comprised of a biocompatible
material, e.g., polymers, polycarbonates, etc., which has an
elastic bending modulus sufficiently low to allow for plastic
deformation of the pod assembly 270 to occur. A barrier 286 having
a plurality of openings 288 defined over its surface may be
positioned between pod walls 272,274 such that tissue acquisition
chamber 284 is defined as shown. A vacuum chamber 290 may be
located beneath barrier 286 with vacuum plenum 292 defined by
chamber 290 and barrier 286.
[0110] In operation, as shown in FIG. 13B, tissue 294 may be
acquired against or within acquisition chamber 284 by the
application of a relatively low pressure vacuum force applied
through plenum 292, which may create a low vacuum within chamber
284 through openings 288. Once the tissue 294 has been first
acquired, a higher pressure vacuum force may be applied through
plenum 292 such that pod walls 272,274 and undercut sections
276,278, respectively, are plastically deformed and drawn towards
one another in the direction of the arrows, as shown in FIG. 13C.
As the undercut sections 276,278 are drawn inwards and shown in
FIG. 13D, the acquired tissue 294 may become pinched at retained
tissue region 296 resulting in a temporary mechanical fixation of
the tissue. A cessation of the high vacuum force may then result in
a relaxation of the 20 pod walls 272,274 and ultimately of the
release of the acquired tissue 294 when the vacuum force is ceased
altogether. Spearing mechanisms or a plurality of sharp hooks may
also be used, in conjunction with, or in lieu of, the undercut
sections described above.
[0111] Yet another variation of a gastroplasty device 300 is shown
in the perspective views of FIGS. 14A to 14D. This particular
variation may utilize a parallel translational motion in moving the
cartridge member 306 and anvil member 308 between the open and
closed configuration rather than a pivoting motion, as described
above in other variations. As shown in FIG. 14A, device 300 may
comprise pod assembly 302 connected at the distal end of elongate
tubular member 304. Septum 310 may be removably positioned between
cartridge member 306 and anvil member 308. A groove plate 312
defining a longitudinally extending slot may be positioned adjacent
to cartridge member 306 and anvil member 308 on a side opposite to
that of septum 310.
[0112] FIG. 14B shows cartridge member 306 and anvil member 308
articulated away from one another into an open configuration while
maintaining a parallel orientation relative to one another. In this
open configuration, tissue may be acquired and drawn into
respective pod members 302 on opposite sides of septum 310. Groove
plate 312, which may be comprised of various biocompatible
materials, e.g., stainless steel, polycarbonate, various polymers,
etc., may be held stationary relative to pod assembly 302 and may
further help maintain cartridge member 306 and anvil member 308 in
their parallel orientation during reconfiguration. FIG. 14C shows
septum 310 removed from between cartridge member 306 and anvil
member 308 by being translated distally via septum control member
314, which may be articulated from a proximal end of elongate
member 304. Once the septum 310 has been removed, cartridge member
306 and anvil member 308 may be articulated to clamp onto the
tissue while maintaining their parallel configuration, as shown in
FIG. 14D. Once the tissue has been clamped, cartridge member 306
may be actuated to fasten the tissue. FIG. 14E shows a
cross-sectional perspective view of a portion of pod members 302 in
an open configuration with septum 310 still in place between
cartridge member 306 and anvil member 308. As shown, cartridge
member 306 and anvil member 308 along with acquisition chambers
316,318, respectively, may be seen maintaining a parallel
configuration relative to one another.
[0113] FIG. 15 shows a perspective view of yet another variation of
a gastroplasty device 320 positioned upon the distal end of
elongate tubular member 336. Similar to the device of FIG. 14A,
cartridge member 322 and anvil member 324 may be configured to open
and close while maintaining a parallel configuration relative to
one another. Optional septum 326 may also be positionable between
members 322,324. However, device 320 may comprise a translationally
movable trolley plate 328 which may be advanced or retracted
longitudinally. At least two wedging members 330,332 may protrude
from plate 328 at an angle which correspondingly abuts with the
distal ends of members 322,324 such that when plate 328 is
longitudinally translated, wedging members 330,332 may drive
cartridge member 322 and anvil member 324 towards one another in a
parallel configuration to clamp onto any tissue which may have been
acquired by device 320. A septum groove 334 may be defined
longitudinally along the plate 328 so as to enable unhindered
movement relative to the septum 326. Cartridge member 322 and anvil
member 324 may also be configured such that when trolley plate 328
compresses the members 322,324 onto tissue, fasteners are
automatically deployed into the tissue to fasten it.
[0114] FIGS. 16A to 16C show side, end, and bottom views,
respectively, of another variation of gastroplasty device 340.
Generally, while other variations have enabled movement of
respective pod members, this variation may maintain a static
acquisition pod. Vacuum pod 342 may be comprised of a variety of
biocompatible materials, e.g., polycarbonate, etc., shaped into
opposing walls having vacuum plenums 348,350 defined along the
lengths of the opposing walls. While two vacuum plenums are
depicted, it should be understood that any number of vacuum plenums
may be employed as well. For example, a single vacuum plenum may be
used. Similarly, three or more vacuum plenums may be used. A septum
having a longitudinal member 346 and an optional perpendicularly
positioned transverse member 344 may be positioned to fit within
vacuum pod 342 such that at least two tissue acquisition chambers
352,354 are formed along the length of pod 342. Alternatively, the
septum may only include longitudinal member 346, and may omit any
transverse members entirely, which may aid in reducing the overall
profile of the distal working end of the device. The septum may
generally be comprised of a similar material as vacuum pod 342 and
may be further coated with a layer of a lubricious material, such
as Teflon.RTM.. Furthermore, the septum may be formed of a
bioabsorbable material that may either dissolve upon exposure to
gastric fluids after tissue has been acquired, or may be
releaseably attached to pods or chambers and fixed in place between
tissue folds (e.g. left behind) once device is removed. The septum
may also have end member 356 at one end of the septum which may act
as a stop for the device 340. FIG. 16D shows a perspective view of
acquisition device 340 revealing the vacuum plenum defined along
the bottom of pod 342. While rectangular devices are depicted in
FIGS. 16A-16D, it should be understood that the device 343 can have
a curved or arcuate shape as well, as shown in FIG. 16E. Also
depicted there are optional septum 345 and a single vacuum plenums
347.
[0115] To facilitate the acquisition of the tissue, various
features may be incorporated into any of the variations described
herein. For instance, one optional feature may be seen in FIG. 17,
which shows a perspective view of gastroplasty device 360 having a
plurality of projections or serrations 366,368 defined along the
mating surfaces of cartridge member 362 and/or anvil member 364.
Serrations 366,368 may be positioned adjacent to the cartridge
and/or anvil to provide additional mechanical support of the tissue
positioned between clamped members of the acquisition device 360
during tissue fixation. Alternatively clearance cuts (not shown) on
the cartridge may be included to reduce the surface area and
required clamping force for fixation, as well as adding traction to
the system. As described above, spearing mechanisms, or sharp
projections may be used as well.
[0116] Another optional feature which may be integrated with the
devices herein is shown in the perspective view of gastroplasty
device 370 of FIG. 18A. A single pod member 372 is shown for
illustrative purposes as the feature of a rotatable shaft may be
integrated into any of the devices described herein. Pod member 372
may define an opening 374 along its length for receiving tissue
therein, as described above; however, the device may also comprise
at least one rotatable shaft 376 positioned longitudinally within
the pod member 372 adjacent to the opening 374. The rotatable shaft
376 may define one or several projections or serrations 378 along
its surface such that tissue drawn into the opening 376 via a
vacuum force may also be mechanically acquired by rotation of the
shaft 376 in a first direction to allow serrations 378 to become
affixed to the tissue. The shaft 376 may be rotated in a second
opposite direction to release the acquired tissue. Moreover, the
pod member 372 may acquire the tissue with the vacuum force alone,
as described above, with the rotatable shaft 376 alone, or with a
combination of both the vacuum force and shaft 376 operated in
conjunction with one another. FIG. 18B shows a cross-section of pod
member 372 having a second rotatable shaft 380 also defining
projections or serrations 382 along its surface. In the case of two
shafts utilized together, they may be configured to be
counter-rotating such that the acquired tissue 384 is optimally
retained within opening 374. Likewise, to release the acquired
tissue 384, the shafts 376,380 may be counter-rotated in the
opposite direction.
[0117] Yet another feature which may be integrated with the devices
herein is shown in the perspective view of FIG. 19A, which
illustrates acquisition and fixation device 390 having a single pod
member for the sake of clarity. Also shown are septum 400 and
opening 402. A segmented staple cartridge 392 having an adjustable
curvature and height may be integrated into any number of the
devices described above. Cartridge 392 may be comprised of one or
more staple cartridge segments 394 which are pivotally connected to
one another via joints 396 which may allow not only pivotal
side-to-side motion between segments 394 but also height
adjustments relative to one another.
[0118] Each staple cartridge segment 394, as seen in the detail
perspective view of FIG. 19B, may each define staple openings 398.
In connecting with adjacent cartridge segments 394, a radiused
pivot member 404 may extend from one side of the segment 394 and a
receiving cavity 406 may be defined in the opposite side of the
segment 394. Each pivot member 404 may extend away from segment 394
such that when positioned into a corresponding receiving cavity
406, adequate spacing exists between segments 394 such that
side-to-side motion is possible between the segments 394 to define
a curvature of the resulting cartridge 392. Moreover, because of
the translational fit between pivot member 404 and cavity 406, the
heights of different segments 394 may be varied to define a curve
in the height of cartridge 392, as shown by height differential Z
in FIG. 19A and the height differences between adjacent segments
394 in FIG. 19B. Accordingly, cartridge 392 may be varied in length
by varying the number of segments utilized, as well as varied in
curvature and in height. The corresponding anvil member may be
adjusted to accordingly match the curvature of the cartridge
392.
[0119] In addition to variations on types of pod members and tissue
acquisition enhancements, the septum may also be adjusted in
various ways to accommodate different devices and desired results.
For instance, gastroplasty device 410 may be seen in the
perspective view of FIG. 20A with one variation of septum assembly
412 positioned between pod members 422,424. Septum assembly 412 may
be seen in better detail in the perspective view of FIG. 20B. In
this variation, the septum may have a transverse septum member 414
perpendicularly positioned relative to longitudinal septum member
416 extending from extension member 420, as described above.
However, this variation may define a tapered edge 418 along the
proximal edge of longitudinal septum member 416. This tapered edge
418 may extend at an acute angle from extension member 420 towards
transverse septum member 414 to facilitate removal of the septum
assembly 412 from within the hollow body organ.
[0120] Another alternative on septum variations is shown in the
perspective views of FIGS. 21A and 21B. Ribbed septum assembly 430
may generally comprise transverse septum member 432, longitudinal
septum member 434, tapered edge 440 extending between extension
member 438 and transverse septum member 432. However, the septum
members 432,434 may be ribbed 436 to facilitate collapse of the
septum assembly 430 when withdrawn from the hollow body organ. The
hardness and geometry of the septum assembly 430 may be accordingly
configured to provide adequate strength during vacuum-assisted
tissue acquisition yet flexible enough to collapse when removed
from the patient. FIG. 21C shows one example of how collapse of the
septum may be facilitated by withdrawing the septum into a
receiving member 442 having a tapered opening 444. As the septum
assembly 430 is pulled into channel 446, the ribbed surfaces may
collapse into a smaller configuration for withdrawal.
[0121] Another alternative septum variation 450 is shown in the
perspective view of FIG. 22A. Longitudinal septum member 452 may
have at least two transverse septum members 454,458 extending to
opposite sides of longitudinal septum 452. Each of the transverse
septum members 454,458 may define a helical tapered edge 456,460,
respectively, such that removal of the septum assembly 450 from the
hollow body organ is facilitated. FIG. 22B shows an end view of the
septum assembly 450 positioned between pod members 462,464.
[0122] Rather than using a perpendicularly-configured septum, an
alternative may be to utilize a septum member having only a
longitudinally extending member which extends sufficiently high so
as to prevent cross-acquisition of tissue into the pod members.
FIG. 23A illustrates an end view of an extendable septum assembly
470 positioned between pod members 472,474 placed against stomach
tissue 476. FIG. 23B shows a side view of one variation for
extending the septum assembly 478 from a low profile delivery
configuration to an extended deployed configuration. Once septum
assembly 478 has been advanced into a hollow body organ in its low
profile configuration, the assembly 478 may be deployed into its
expanded configuration. An extension septum member 480 may have a
number of projections 482,484 protruding from either side of
extension 480. A corresponding longitudinal septum base 486 may
define channels 488,490 through which projections 482,484 located
on extension 480, respectively, maybe translated within. Moreover,
channels 488,490 may be angled relative to a longitudinal axis
defined by septum base 486 such that distally advancing extension
480 relative to septum base 486 raises extension 480 a distance
away from base 486, effectively increasing a height of the septum
assembly 478. Projections 482,484 and channels 488,490 may be
covered so that travel of the extension 480 is uninhibited by
surrounding tissue.
[0123] Similarly, FIG. 23C shows a side view of another septum
assembly variation 492 in which extension septum member 494 is
extendable from base septum member 496. When advanced distally
relative to longitudinal septum base 496, extension 494 may
travserse channels 498, which form ramped channel portion 500,
defined within base 496 to extend into a septum assembly 492 having
an increased height.
[0124] FIG. 24A shows another alternative septum assembly 510 which
may be configured to deploy an extendable septum from a rolled-up
configuration. As seen in the end view, septum assembly 510 is in a
deployed configuration between pod members 512,514. Retractable
septum 520, may be extended from a rolled-up configuration within
drum 516, which may be positioned between opposing transverse
septum members 518. Cables 522 may extend from transverse septum
members 518 for attachment to pod members 512,514. After the tissue
has been acquired, retractable septum 520 may be retracted into
drum 516 via manipulation of control cable 524, as seen in FIG.
24B, to assume a low profile for withdrawal from the patient.
[0125] Another variation of septum assembly 530 is further shown in
the perspective views of FIGS. 25A and 25B. Septum assembly 530 may
comprise transverse septum member 532 and collapsible septum member
534, which may be configured between a collapsed configuration and
an extended configuration. Transverse septum 532 may be elevated
and lowered relative to pod members 548,550 during delivery and
deployment of septum assembly 530, e.g., via crossmembers 536,538
which may be configured into a scissors-type mechanism.
Cross-members 536,538 may have its proximal ends connected to
control cable 542, which may be routed through extension member
544, while an intermediate portion of both cross-members 536,538
may be pivotally connected to one another via pivot 540. Thus,
articulation of control cable 542 from its proximal end by the
surgeon or physician may actuate the scissors mechanism to either
raise or lower transverse septum 532 in the directions of the arrow
as shown. Transverse septum 532, when positioned between pod
members 548,550, may be secured via cables 546, as shown in FIG.
25B.
[0126] FIGS. 25C and 25D show end views of transverse septum 532
and the collapsible septum member in an expanded or extended
configuration 552 and in a collapsed configuration 554. The
collapsible septum member may be enclosed by a biocompatible
material to prevent pinching of tissue by the cross-members
536,538. Moreover, the material covering the collapsible septum may
also be distensible, if desired. Various materials may be utilized,
e.g., nylon, polymeric materials, woven materials made from various
polymers, latex, elastomers, etc.
[0127] FIGS. 26A to 26C show end, bottom, and perspective views of
yet another alternative septum 560. This particular septum 560 may
be utilized with the device 340 of FIGS. 16A to 16D. As shown,
longitudinal septum 562 may be perpendicularly and integrally
connected with transverse septum member 564 at one end and base
septum member 566 at an opposing end of longitudinal septum 562.
Transverse septum member 564 may define radiused corners 568 at
each of its four corners such that an atraumatic surface is
presented to the tissue during use within a patient. Moreover,
septum 560 may be extruded or formed from a singular piece of
biocompatible material (any of the biocompatible materials suitable
for such a structure as discussed herein may be utilized) such that
a uniform structure is created.
[0128] FIGS. 27A and 27B show perspective views of an alternative
septum assembly 570 which may also be utilized particularly with
the device 340 as discussed above. FIG. 27A shows septum 570 in a
low profile delivery configuration where septum 570 may generally
be comprised of two elongate T-shaped members. Each of the T-shaped
members may be further comprised of longitudinal septum members
572,572' and transverse septum members 574',574', respectively.
Each of the two elongate T-shaped members need not be uniform with
one another depending upon the device into which the septum
assembly 570 is placed, but each member may be pivotally connected
to one another via pivot 576 at a corner of adjacent longitudinal
members 572,572'. Thus, during delivery of the device and septum
570 into the patient body, the low profile configuration of FIG.
27A may be maintained and prior to or during tissue acquisition and
fixation, one of the members, e.g., septum members 572',574' may be
pivoted in the direction of the arrow such that the longitudinal
portions of the septum 572,572' contact one another to form an
acquisition configuration 578 for the septum assembly, as shown in
FIG. 27B. After tissue acquisition and fixation, the septum may be
reconfigured into its low profile configuration for removal from
the patient.
[0129] The septum in any of the above embodiments may be formed of
a bioabsorbable and/or biocompatible material such as polyester
(e.g., DACRON.RTM. from E. I. Du Pont de Nemours and Company,
Wilmington, Del.), polypropylene, polytetrafluoroethylene (PTFE),
expanded PTFE (ePTFE), polyether ether ketone (PEEK), nylon,
extruded collagen, silicone, polylactic acid (PLA),
poly(lactic-co-glycolic acid) (PLGA), or polyglycolic acid (PGA).
Furthermore, it may be flexible, biocompatible material which can
either be left behind within the partition or expelled distally,
and either absorbed within the stomach, or digested and expelled
through the patient's gastrointestinal tract.
[0130] As discussed above, once the gastroplasty device has
acquired the appropriate tissue, the device may be clamped upon the
tissue to be fastened. Clamping multiple layers of tissue to one
another may require a clamping mechanism which is configured to
deliver a high degree of clamping pressure. One example of such a
clamping mechanism 580 is shown in the perspective views of FIGS.
28A to 28C, which show one variation for opening the clamp.
Clamping mechanim 580 may have attachment members 582,584 for
secure connection to each of a pod member. Each of the attachment
members 582,584 may be connected to one another via rotatable cams
586,588, where each cam may have a rotatable pivot, 590,592,
respectively, protruding therefrom. FIG. 28A shows clamping
mechanism 580 in a closed and clamped configuration while FIG. 28B
shows the mechanism 580 being initially opened. To open (or close)
the mechanism 580, cam 586 may be rotated by actuating a control
cable 600, which may be routed, for instance, through a tubular
member 596 positioned within the elongate member 12, from its
proximal end. Cam 588 may then be rotated by actuating control
cable 602, which may be routed within tubular member 598 also
through tubular member 596. Because attachment members 582,584
rotate about pivot 590, a channel 594 may be defined in member 582
within which pivot 592 may translate when cam 588 is rotated to
effectuate clamping or opening of the pod members.
[0131] In addition to a cam mechanism 580, clamping cables may also
be utilized, as discussed above. FIG. 29A shows a perspective view
of one example of how clamping cables may be routed through an
acquisition and fixation device 610. As seen, device 610 having pod
members 612,614 may be pivotable about longitudinal pivot 616.
Although a pivoting device is shown in this variation, the routing
of cables may be utilized in any of the other acquisition and
fixation devices utilizing pivoting motion as well as parallel
clamping. A first clamping cable 620 may be routed into one of the
pod members, e.g., pod member 614, through positioning member 630
mounted on pod member 614 and routed over pulley or radiused member
622, also contained within pod member 614. First cable 620 may be
looped 632 adjacent to pivot 616 to allow for placement of the
septum (not shown for clarity) and then anchored to clamping cable
anchor 618. Likewise, second clamping cable 626 may be routed
through positioning member 630 adjacent to first clamping cable 620
and through pod member 614 and over pulley or radiused member 628,
also contained within pod member 614. Second cable 626 may also be
looped 632 adjacent to pivot 616 to allow for placement of the
septum and then anchored to clamping cable anchor 624.
[0132] FIG. 29B shows a cross-sectioned end view of a parallel
clamping device with the septum 634 shown. Like features are
similarly numbered as corresponding features from FIG. 29A. As in
the pivoting variation, first 620 and second 626 clamping cables
may be routed through corresponding tubular members 640 and the
cables may be looped through one or more slots 642 defined in
septum 634 and subsequently routed into the opposing pod member for
anchoring. Clamping cables 620,626 are preferably routed to
facilitate the unhindered translation of septum 634 as well as to
ensure unobstructed access to openings 636,638 for the tissue to be
acquired and fastened.
[0133] In yet another clamping variation, FIGS. 30A and 30B show
side and edge views of an alternative gastroplasty device 650
utilizing linked pod members. Cartridge member 652 and anvil member
654 may be connected to one another via linking arms 656,658
pivotally attached to one another via pivot 660 at one end of the
device 650 and via linking arms 662,664 also pivotally attached to
one another via pivot 666 at the opposite end of the device 650.
Clamping cables 672 may be routed through tubular member 670 into
the device 650 and over pulleys 674,676, as described above, for
moving anvil member 654 between an open and closed configuration
when acquiring tissue within acquisition region 668. Firing cable
678 may be manipulated to deploy the fasteners from within
cartridge member 652 when anvil member 654 is clamped over the
acquired tissue. Deployment of the fasteners from cartridge member
652 may be achieved by incorporation of the firing wedge and other
mechanisms as taught in U.S. Pat. No. 4,610,383, which is hereby
incorporated by reference in its entirety. In addition, clamping
may be accomplished via hydraulic, pneumatic, or electropneumatic
mechanisms, as discussed above.
[0134] Another variation of a gastroplasty assembly 700 is shown in
FIG. 31. Assembly 700 may be generally comprised of an elongate
tubular member 702 having a proximal end 704 and a distal end 706
with a lumen 708 defined within the elongate member. As shown in
FIG. 31, a handle assembly 710 is connected at the proximal end 704
of the elongate member, and a tissue treatment device 712 is
attached at the distal end 706 of the elongate member. The tissue
treatment device is used to form either single or dual fold
plications within a stomach cavity.
[0135] The elongate member 702 may have a circular or elliptical
cross-sectional area. Alternatively, the cross-sectional area may
take on any number of different cross-sectional configurations,
e.g., hexagonal, octagonal, etc., provided that it presents an
atraumatic surface to the tissue surfaces within the body. In the
embodiment shown, the elongate member 702 is a flexible shaft
including a series of sliding links 714 that increase the
flexibility of the elongate member, and hence increase the ease in
which the device is handled and operated. The lumen 708 may extend
entirely through tubular member 702 and may be sized to provide
access to the distal end 706 for various surgical tools or
therapies once the distal end of assembly 700 is positioned within
a hollow body organ, and in particular may be useful to place an
endoscope or other visualization tool. Alternatively, a fiberscope
or other type of visualization tool may be integrated within the
elongate member. Alternatively, an optional separate thin walled
oversheath, may also be placed over the acquisition device,
including the elongate member, to assist in placement, or may be
placed over a guidewire or obturator down the esophagus prior to
placement of the gastroplasty device and removed with the
gastroplasty device once the procedure is complete. The liner may
be made of a thin wall polymer such as polyolefin,
polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE), silicone and
the like, having a wall thickness between 0.001'' and 0.025''. This
liner can serve to guide the gastroplasty device, as well as help
to limit trauma to the esophagus and other delicate structures.
[0136] FIG. 32 shows a perspective view of three sliding links 714
attached to one another. Several sliding links 714 are attached to
one another depending on the desired length of the elongate member
702. Typically, the length of the elongate member is determined by
the anatomic length on a patient such that the distal end of the
device reaches into the patient's stomach while the proximal end
extends out of the patient's mouth for a length sufficient to
enable the user to manipulate the controls of the device,
approximately 30 cm-80 cm long, for example 50 cm-70 cm. Each
sliding link 714 includes a circular outer surface 716 with a first
end 718 and a second end 720. In one embodiment, the first end 718
of the sliding link includes four slots 721, and the second end 720
includes four legs 722 that project parallel to the axis of the
circular outer surface of the links. The links are joined together
by inserting the legs on one link into the slots of the adjacent
link, and then two legs 722a opposite each other of one sliding
link are bonded or adhered in the slots of the adjacent link. The
remaining two legs 722b of an individual sliding link not bonded
into slots are free to move within the slot of the adjacent link
when the elongate member 702 is curved as shown in FIG. 32. To
allow for maximum flexibility, the position of the bonded legs 722a
alternates with each sliding link 714. In other words, since all of
the legs 722 of the sliding links are in-line with each other and
there are four sets of legs that are in-line with each other, every
other leg in one of the four sets is bonded to the adjacent link.
When flexed, the bonded legs 722a flex at a joint 724 which also
improves flexibility. The design of the sliding links 714 also
allow them to transmit torque along the length of the elongate
member 702. In one embodiment, a polyethylene tape is wrapped
around the outer surface of the elongate member 702 to limit trauma
to the esophagus and other delicate structures, while still
allowing the elongate member to flex while limiting extensibility
of the shaft. Other materials that may be used as coverings may
include silicone, urethanes, or other polymers. In a further
embodiment, such coatings may be sprayed on or applied as a coating
or sheath, rather than wound as tape. However, it has also been
contemplated that the elongated member 702 may be formed using
braided, molded, or slotted material, such as any metal or polymer.
The elongated member may even be formed with a polymer that does
not includes links.
[0137] Referring now to FIG. 33, which is a cross-sectional view
taken along line 33-33 of FIG. 32, the internal cavity of the
sliding link 714 is shown to include an inner arch 726 that divides
the lumen 708 into an endoscope lumen 728 and a working lumen 730.
The endoscope lumen is sized so that an endoscope may pass there
through. In one embodiment, the inner arch is only formed within
every other sliding link in the chain that forms that elongate
member 702 to help increase the flexibility of the elongate member.
However, in another embodiment, the inner arch may be formed within
every sliding link. The working lumen 730 provides a passage for
various cables for controlling the opening and closing of members
732 and 734 as well as additional cables for actuating deployment
of the fasteners/staples from within the staple cartridge.
Moreover, the working lumen 730 may be used for the passage of
vacuum tubes connected to vacuum pods formed within the members 732
and 734, and for the passage of retractor wires and septum wire
(used to remove septum from between the members 732 and 734). These
passages provided by the working lumen 730 prevent gross movements
of the cables and coil pipes, and also keep the endoscope free from
entanglement. The working lumen within the elongated member allow
small movements of the cables and coil pipes which may be important
during bending of the shaft.
[0138] Referring back to FIG. 31, the tissue treatment device 712
attached to the distal end 706 includes a cartridge member or jaw
732 placed longitudinally in apposition to anvil member or jaw 734.
When the tissue treatment device is in use, the tissue of the
stomach wall (including, in some instances, the muscular tissue
layers) are adjusted or tensioned around the perimeter of the
distal working portion, and within the distal working portion inner
volume, to achieve a desired resulting geometry (e.g., small
gastric pouch or restrictive partition or baffle). Thus, the
gastric pouch volume may be predetermined by adjusting the volume
of the tissue treatment device, inner or outer profile. Cartridge
member 732 may contain one or several fasteners, e.g., staples,
clips, etc., which may be actuated via controls located proximally
on handle assembly 710. A septum or barrier 736, may be removably
positioned between cartridge member 732 and anvil member 734 while
connecting member or pin 738 may connect the device 712 to the
tubular member 702. An atraumatic distal tip 740 can also be
attached to the distal end of the tissue treatment device to limit
trauma to the esophagus and stomach cavity. In this embodiment, the
atraumatic distal tip is a split flexible tip that opens and closes
with the jaws 732 and 734 of the tissue treatment device. There is
also a retractor wire 742 attached to a sail 744 that is extendible
above the septum. The tissue treatment device including the
retractor wire and sail are described in more detail with reference
to FIGS. 76-80 of U.S. patent application Ser. No. 11/282,320,
which was filed on Nov. 17, 2005, and is hereby incorporated by
reference in its entirety.
[0139] In this embodiment, both members 732 and 734 of the tissue
treatment device 712 also define openings 741 and 743,
respectively, along a portion of the length or the entire length of
each of the members 732, 734. One or both of these openings 741,
743 may be connected via tubing through elongate member 702 to the
vacuum ports located at the handle assembly 710. Alternatively, a
central vacuum lumen may supply both ports, or may bifurcate at the
proximal or distal end of flexible member 702. Targeted tissue can
be sucked into these openings 741, 743 when a vacuum is applied. To
prevent tissue from becoming caught or snagged onto the edges of
the openings 741, 743, baskets 749 with holes can be placed within
the openings 741, 743. One embodiment of a basket 749 is shown in
FIG. 38, that has rows of three holes per side, and with each
individual hole measuring about 0.70 inch in width and about 0.060
inch in height. Baskets 749 with any number of rows of holes per
side and with a variety of sizes have also been contemplated. Also,
to prevent "snagging" of tissue, the outside of the tissue
treatment device is designed to be as smooth as possible. This
allows tissue to "flow" around the device and into the openings. It
may also be desired to effect the outside shape so that the
acquisition slows the flow of certain tissue to acquire more of a
particular target tissue, i.e. slow the flow of mucosa into the pod
to allow more serosa to be gathered.
[0140] A detailed view of one embodiment of the tissue treatment
device 712 is shown in FIGS. 34 through 36. The cartridge member
732 and anvil member 734 may be both or singularly articulatable
relative to one another or relative to elongate member 12. A hinge
745 longitudinally positioned between cartridge member 732 and
anvil member 734 may be configured to enable the device to be
pivoted into an open configuration for the acquisition of tissue
and a closed or deployment configuration for delivery or
advancement of the device into the hollow body organ. In one
embodiment, the retractor wire 742 extends from the proximal end
704 of the elongate member 702 to the tissue treatment device and
through the hinge 745 that pivots the members 732 and 734. In an
alternative embodiment, the wire retractor extends through a strap
766 that is attached to the backside of the tissue treatment
device.
[0141] As best shown in FIG. 36, a first end 746 of the retractor
wire is curved and includes an eyelet 747 that provides an
attachment point for an end of a tether wire 748, which is attached
to the sail 744 and the optional septum 736 located between the
cartridge member and anvil member. In an alternative embodiment,
the sail element may serve the function of the septum in its
extended form. With the first end of the retractor wire secured to
the tissue treatment device, the remaining portion of the retractor
wire loops around the tissue treatment device and through the
flexible elongate member 702, where the second end (not shown) is
positioned at the proximal end 704 of the device 700. In the
extended configuration as shown in FIG. 36, the sail acts as a
barrier and ensures that the target tissue enters the appropriate
vacuum pod without crossing over into the other vacuum pod. It has
also been contemplated that that the tissue treatment device does
not include a septum, and the sail 744 is attached between the jaws
of the tissue treatment device. In this embodiment, the sail may be
attached to the tissue treatment device with a pin or wire through
the hinge located between jaws 732 and 734.
[0142] When the tissue treatment device 712 is in the delivery
position with the jaws 732 and 734 closed as shown in FIG. 34, the
first end of the wire retractor rests inside a gap or slit 752 (see
FIG. 35) formed in the split flexible tip 740 and the sail is in a
collapsed position so that it is folded between jaws 732 and 734.
In use, when the tissue treatment device is positioned within the
stomach, the retractor wire 742 is extended by pushing the wire
distally, and since the first end of the wire is anchored to the
tissue treatment device via the tether, excess wire forms a loop
750 or other space occupying geometry within the stomach cavity. In
this retraction position as shown in FIG. 36, the loop formed with
the wire retractor pushes or blocks unwanted tissue away from the
tissue treatment device. In some embodiments, the wire retractor is
a nitinol wire, although any material, including stainless steel or
a comparatively stiff polymer, can be used to form the wire
structure. Extending the retractor wire 742 also raises the sail
744 by pulling the tether 748 away from the tissue treatment
device. Targeted tissue is drawn into vacuum pods located in the
cartridge member 732 and the anvil member 734 when a vacuum is
created, and the extended sail 744 acts as a barrier to prevent
tissue from crossing over from one pod to the other. This helps to
ensure that the plication or staple line formed in the stomach
cavity is continuous without any gaps or holes.
[0143] In one embodiment, the shape of the sail 744 is defined by
the tether wire 748, which as shown in FIG. 36 is a triangle,
although other shapes may be used such as circular, oval, or any
polygonal shape. The sail may be formed of any flexible material,
for example polyethylene tape including polyethylene film with an
acrylic adhesive, that is wrapped around and secured to the tether,
which in one embodiment may be a Kevlar aramid line. Other
materials that can be used to form the sail include any plastic or
flexible material, for example the sail element may be cut from a
sheet of material, or molded to a particular shape. Such other
materials may include polyester (e.g., DACRON.RTM. from E. I. du
Pont de Nemours and Company, Wilmington, Del.), polypropylene,
polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE), nylon, or
silicone. In one embodiment, the tether 748 is also secured through
holes of the septum 736, however, the sail 744 may be attached
directly to the septum. It has also been contemplated that the
first end 746 of the retractor wire 742 is directly attached to the
sail without the use of a tether wire. Still in another embodiment,
the retractor wire may be attached to the septum with the sail
attached to the retractor wire and the septum, as shown in one
embodiment of U.S. patent application Ser. No. 11/282,320, which
has already been incorporated by reference.
[0144] As shown in FIGS. 34-36, the split flexible tip 740 includes
a cylindrical body with a proximal end 754 and a distal end 756.
The split or gap 752 is formed at the proximal end of the
cylindrical body and is wide enough to house the first end 746 of
the retractor wire 742 when the device is in its delivery
configuration. The cylindrical body includes a progressive taper
towards the distal end for insertion through the esophagus. Also,
the cylindrical body may include a guide wire lumen 758 so the
device can track along a guide wire that has been positioned within
the stomach cavity. The proximal end 754 of the split flexible tip
740 can be attached to the distal end of the tissue treatment
device 712 with an adhesive and/or mechanically with pins or a post
extending from the tissue treatment device. If adhesive is used,
the surface area at the cross section of the proximal end of the
cylindrical body should be nearly as large as the surface area of
the ends of the jaws 732 and 734. The split or gap 752 allows the
split flexible tip 740 to open (see FIG. 35) and close (see FIG.
34) with the tissue treatment device 712, and provides a space for
the retractor wire to extend through. In order for the split
flexible tip to open and close and be atraumatic to the tissue of
the patient, it is formed of a flexible elastomeric material, such
as silicone rubber.
[0145] As best shown in FIG. 37, an endoscope shroud or sleeve 760
is attached to the backside of the tissue treatment device 712. The
shroud 760 provides a passageway for an endoscope EN, and the
passageway starts from the distal end 706 of the flexible shaft or
elongate tubular member 702 and ends along the backside of the
tissue treatment device 712. It is possible for the shroud to
extend any length along the tissue treatment device, and it may
even extend past the distal end of the tissue treatment device. In
one embodiment, the tubular structure of the shroud is formed by
layers of tape, such as polyester tape including polyester film
with an acrylic adhesive, although any flexible material may be
used to form the shroud. Other materials include polyethylene tape
including polyethylene film with an acrylic adhesive, or polyimide
tubing. In some embodiments the shroud may be molded or formed over
a mandrel and then attached to the tissue treatment device. It is
preferable that the shroud surface be smooth and flexible to be
atraumatic to the esophagus when passed to the treatment area. A
collar 762 is attached to an end ring 764 located at the distal end
706 of the flexible shaft 702, and the proximal end of the shroud
is attached to or wrapped around the collar as shown in FIG. 37.
The shroud is then attached to the tissue treatment device by being
wrapped around a strap 766 attached to the backside of the tissue
treatment device 712 that may also provide a passageway for the
retractor wire in some embodiments. In other embodiments that do
not include the strap 766, the shroud 760 can be adhesively
attached to the tissue treatment device. In use, the shroud tube
lumen directs the endoscope EN around the jaws of the tissue
treatment device for viewing the procedure. Also, the shroud 760
cradles or contains the endoscope to prevent the scope from
torqueing or extending out of the insertion plane or extending into
the lesser curve of the stomach organ which would affect the
placement of the tissue treatment device, or in a variety of
directions that may impact the resulting geometry of the
gastroplasty or pouch.
[0146] In one embodiment, the cartridge member 732 may contain a
removable staple cartridge 768 containing fasteners along an outer
edge of the member 732 while the anvil member 734 may have an anvil
positioned along an outer edge of the member 734 such that the
anvil corresponds to the number and position of fasteners within
removable staple cartridge 768. The cartridge 768, which is shown
in FIG. 39, is removable so that during a procedure, more than one
staple line may be formed within the stomach cavity using the same
gastroplasty assembly 700. Referring to FIG. 39, the staple
cartridge 768 includes a staple housing 770 that stores the
staples, with a top end 772 and a bottom end 774. The top end
includes staple apertures 776 where the staples are ejected from
tissue. To lock the removable cartridge 768 into the cartridge
member 732, the housing 770 includes a locking pin 778 attached to
a flexing beam 780 that is attached to the housing as shown in FIG.
39. There is also a lift shelf 782 disposed within the housing 770
that provides an area to grab and lift the staple cartridge out of
the cartridge member 732. Referring now to FIG. 40, the removable
cartridge 768 is locked in position within the cartridge member
732. As shown, the cartridge member 732 includes a lock hole 784
that receives the flexible locking pin 778 of the removable
cartridge 768. The cartridge member 732 also includes a lift
clearance 786 that provides access to the lift shelf of the
removable cartridge 768. To remove a dispensed cartridge 768 from
the cartridge member 732, an instrument can be inserted through the
lock hole 784 to press or move the locking pin 778 away from and
out of the lock hole. At the same time, another instrument can be
inserted into the lift shelf 782 to pry the cartridge 768 out of
the cartridge member 732. A full cartridge may then be placed into
the cartridge member 732 so that the locking pin 778 snaps into
position within the lock hole 784.
[0147] To deploy the staples housed within the cartridge 768, a
wedge 788 may be pulled proximally through the cartridge member 732
via a staple actuation wire 790. The actuation wire 790 may be
manipulated at the handle assembly 710 when staples are to be
deployed into the tissue. In one embodiment, as the wedge 788 is
pulled proximally, the wedge engages a staple pusher 792 that is
disposed over corresponding staples 794, a single staple pusher may
be configured to engage multiple staples in adjacent rows. FIG. 41
shows the wedge 788 coming in contact with the staple pusher 792.
Pushers may be designed so that staples contact the anvil at
different times optimizing the required force to fire the staples.
Alternatively, the spacing may be derived from tissue healing
properties. Or a combination of the two may effect the design of
the pushers. The staple pusher 792 may include a sloped surface 796
for slidingly engaging the sloped surface of the wedge. As the
wedge engages the sloped surface 796 of the staple pusher, the
staple pusher is pushed towards staples as the pusher is guided via
one or more guides 798 to fire the staples.
[0148] Still referring to FIG. 41, the wedge 788 is disposed along
a wedge insert 800, which is near the distal end of the cartridge
member 732. The wedge insert 800 includes guides 802 that the wedge
788 follows when it is initially pulled proximally to fire the
staples. Before the device is activated and the staples are fired
into tissue, the wedge 788 is stored along the wedge insert 800
where it does not engage or begin to push the stapler pusher 792
toward the staples. While the wedge 788 is in this starting
position, it is also held in place during handling by a shear pin
804 that is molded into the staple cartridge 768. The shear pin 804
ensures that the wedge 788 does not begin to contact the staples in
the cartridge. In one embodiment, to move the wedge 788 proximally
out of the wedge insert 800 and past the shear pin 804, sufficient
force is provided to the wedge to break the shear pin away from the
cartridge 768 so that the wedge is free to move proximally along
the cartridge member 732. If after firing the staples of one staple
cartridge 768 and the tissue treatment device 712 is to be reloaded
with another staple cartridge 768, the staple cartridge is removed
as described above and the wedge is pushed distally along the
cartridge member 732 until it is positioned back into its starting
position within the wedge insert 800. It is important that the
wedge is pushed back to the starting position, otherwise, when
another cartridge is loaded into the device staples may be
pre-fired due to the position of the wedge. Then, another staple
cartridge is loaded into the cartridge member 732, and the shear
pin 804 molded into this staple cartridge will hold the wedge in
its starting position during handling.
[0149] The tissue treatment device 712 is connected to the distal
end of the elongate member 702 by connecting member 738 that is
attached to an end ring 808 disposed at the distal end of the
elongate member. A cross-sectional view of the end ring is shown in
FIG. 42 and shows several apertures 810 disposed through the end
ring to provide a passageway for the endoscope, vacuum tubes and
wires. In one embodiment, the apertures are designated as follows:
aperture 810a is a passageway for the endoscope, aperture 810b is a
passageway for the cartridge member vacuum tube, aperture 810c is a
passageway for the anvil member vacuum tube, aperture 810d engages
the connecting member 806 that is attached to the tissue treatment
device, aperture 810d is a passageway for the septum wire
(discussed below), aperture 810f is a passageway for the retractor
wire, aperture 810g is a passageway for the opening cable
(discussed below), aperture 810h is a passageway for the outer
clamping cable (discussed below), aperture 810i is a passageway for
the inner clamping cable (discussed below), and aperture 810j is a
passageway for the staple actuation wire 790. In other embodiments,
the apertures may be rearranged in any design and additional
apertures may be disposed through the end ring for additional
wires.
[0150] Each of the members 732, 734 may have openings to allow for
the routing and passage of clamping cables through the device for
enabling cartridge member 732 and anvil member 734 to be clamped
together and opened. FIGS. 43 and 44 show partial cross-sectional
views taken along the tissue treatment device 712 with the vacuum
tubing and cables routed through the device. As shown, cartridge
vacuum tube 812 and anvil vacuum tube 814 may be routed through
elongate member 702 into a proximal end of each cartridge member
732 and anvil member 734 for fluid connection with respective
openings 741, 743. Outer clamping cable 816 and inner clamping
cable 818 may be passed through elongate member 702 around vertical
pulleys 817 in the cartridge member 732 and across to the anvil
member 734 where the ends may be held in the anvil member with ball
crimps. To clamp cartridge member 732 and anvil member 734 closed,
the cables 816 and 818 are pulled proximately. The closed
configuration of the tissue treatment device 712 is shown in FIG.
43. Opening cable 822 may be passed through elongate member 702
around the horizontal pulley 823 in the cartridge member 732 and
around an open cam 825 to the anvil member 734, where the end is
held in the anvil member with a ball crimp. Members 732, 734 may be
opened with respect to one anther by pulling or tensioning the
opening cable 822 proximately. This open configuration is shown in
FIG. 44.
[0151] Referring now to FIGS. 45 and 46, the handle assembly 710
will be discussed in detail. As shown in FIG. 45, the handle
assembly 710 includes a housing 824 having a transition knuckle 826
that attaches to the elongate tubular member 702. There is a scope
tube and seal mount 828 which allows entry of an endoscope into the
elongate member 702, and a vacuum tube adapter 830 which holds
vacuum tubes 812, 814 and an insufflation tube (not shown) so that
the tubes may be connected to a vacuum device. In one embodiment,
this distal portion of the handle assembly 710 including the
transition knuckle 826, the scope tube seal mount 828, and the
vacuum tube adapter 830 is sealed pressure tight. A clamp/open knob
832 is located at the proximal end of the handle assembly and is in
connection with clamping and opening cables 816, 818, and 822.
Twisting the clamp/open knob in a counter-clockwise direction opens
the member 732, 734 of the tissue treatment device 712, and
twisting the clamp/open knob in a clockwise direction clamps the
members 732, 734 of the tissue treatment device closed. In one
embodiment, there are markings, such as, colored bands and/or
numbers disposed on the housing 824 of the handle assembly adjacent
the clamp/open knob 832 to indicate the force being applied at the
tissue treatment device 712. There is also a wedge fire knob 834 in
this embodiment that is in connection with the staple actuation
wire 790. Turning the wedge fire knob in a clockwise directions
causes the wedge 788 to move proximally with in the cartridge
member 732 to fire the staples 794. A wedge lock 836 is disposed on
the housing 284 near the wedge fire knob and is used to lock the
staple actuation wire 790 in position to prevent the wedge 788 from
being moved prior to forming a staple line within the stomach. In
other embodiments, the wedge fire knob may be replaced with a lever
or other activation means to pull the wedge within the cartridge
member 732. The handle assembly 710 also includes a retractor seal
838 to allow entry of the retractor wire 742 into the elongate
member 702 (while maintaining the sealed portion of the handle). A
proximal end of the retractor wire extends out of the retractor
seal and the user may push or pull the retractor wire during the
procedure to extend and retract the retractor wire within the
stomach cavity. A groove 840 is also disposed on the housing 824
that tracks a septum push-off knob 842 that may be tightened to
secure a septum wire attached to the septum 736. The septum
push-off knob can be moved along the groove 840 to push the septum
wire distally, thereby removing the septum 736 from between the
members 732, 734 when needed, as will be described below. In one
embodiment, a septum key or lock is disposed near the proximal end
of the tissue treatment device between members 732, 734 and fits
within a key slot created along the proximal edge of the septum.
The septum key or lock prevents unwanted motion of septum during
shaft flexing or accidental actuation.
[0152] Referring now to FIGS. 46 through 46B, a push/pull mechanism
848 that is in connection with the clamp/open knob 832 and the
cables 814, 816 and 822 will be described. FIG. 46A shows the
push/pull mechanism in an opened configuration when the jaws 732,
734 of the tissue treatment device 712 are opened. To open the
jaws, the opening cable 822 is tensioned with respect to an open
coil pipe 850. Tensioning is accomplished by turning knob 832
counterclockwise, which pushes a balance bar pivot 852 against a
slide link 854. This pushes a cross pin 856 distally, which moves
the open coil pipe distally and has the effect of tensioning the
opening cable 822. When the knob 832 is turned counterclockwise, a
lead screw 858, which is fixed rotationally, translates with the
balance bar pivot and is pushed distally. Once the balance bar
pivot comes in contact with the slide link, an open thrust bearing
860 begins to compress open springs 862 in a spring holder 864. A
colored line on the outside of the handle housing 824 is used to
determine the amount of compression and therefore the amount of
tension on the open cable.
[0153] FIG. 46B shows the push/pull mechanism 848 in a closed
configuration when the jaws 732, 734 of the tissue treatment device
712 are clamped together. To close or clamp the jaws, the outer and
inner clamping cables 816, 818 are tensioned with respect to clamp
coil pipes 864. Tensioning is accomplished by turning the knob 832
clockwise, which pulls the balance bar pivot 852 and the clamping
cables 816, 818 proximally, and redirects the cables through guide
block 866. When the knob 832 is turned clockwise, the lead screw
858 is pulled proximally to tension the clamping cables 816, 818.
Once the clamp cables begin to tension, a clamp thrust bearing 868
begins to compress clamp springs 870. A colored line on the outside
of the handle housing 824 is used to determine the amount of
compression and therefore the amount of tension on the clamp cables
816, 818. Once the lead screw is pulled proximally so that the
balance bar comes out of contact with the slide link(s), the
tension on the open cables is released. Lead screws can have
various thread pitches to create different clamp/open profiles. For
example, constant thread pitch would cause the jaws to close at a
consistent rate, but a varying pitch (along the lead screw) could
generate sections of the travel to act quicker or slower, i.e. open
fast, close slow, etc.
[0154] Referring to FIG. 46, the wedge fire knob 834 is attached to
a wedge fire mechanism 872 that is attached to the staple actuation
wire 790. To fire the staples at the tissue treatment device 712,
the knob 834 is turned clockwise to pull a lead screw 874
proximally into the knob. The lead screw is rotationally fixed, but
it is free to translate. Attached to the lead screw is a wedge wire
adaptor 876 that tensions the staple actuation wire 790 and pulls
the wedge 788 proximally. Before firing the staples, the wedge lock
836 should first be loosened and removed from a guide pin located
between the lead screw and the wedge wire adaptor.
[0155] In one embodiment, the gastroplasty assembly 700 may be
transorally delivered through the esophagus to create one or more
plications within the stomach cavity. With reference to FIGS.
47-53A, one method of using the gastroplasy device will be
described to form a sleeve or pouch within the stomach cavity.
[0156] In one embodiment, an endoscope EN my be introduced
transorally to the stomach cavity to inspect the upper
gastrointestinal tract and the stomach cavity. A guide wire GW may
then be introduced through the endoscope to the stomach cavity and
the endoscope may be removed from the patient. With the guide wire
in position, a bougie dilator (not shown) is introduced over the
guide wire to dilate the esophagus and the gastroesophageal
junction ("GEJ"). The bougie dilator is removed and the proximal
end of the guide wire is passed through the guide wire lumen 758 of
the distal tip 740 and the tissue treatment device 712 is
introduced through the esophagus and into the stomach cavity until
the tissue treatment device is about 5 cm beyond the Z-line
location as shown in FIG. 47. In one embodiment, there may be
markings along the jaws 732 and 734 to properly position the tissue
treatment device. Next, the guide wire GW is removed and the
endoscope EN is inserted through the scope tube seal mount 828 of
the handle assembly 710, the elongate member 702, and the shroud
760. As shown in FIG. 48, the endoscope EN exits the shroud 760 and
is retroflexed to view the tissue treatment device 712 to verify
that the proximal end of the jaws 732, 734 are at the GEJ. In some
embodiments, the stomach may be insufflated using the insufflation
tube for easier viewing with the endoscope.
[0157] With the endoscope EN still in position to view the tissue
treatment device 712, the jaws 732 and 734 are opened by rotating
the clamp/open knob 832 counterclockwise. At this time the backside
of the tissue treatment device 712, the side including the shroud
760, should be positioned against the lesser curve ("LC") of the
stomach cavity. Next, the retractor wire 742 is advanced by pushing
the proximal end of the retractor wire through retractor seal 838
to retract the greater curvature ("GC") of the stomach with the
excess loop of wire 750. This action also deploys the sail 744 as
shown in FIG. 49. At this stage, the vacuum tubes 812, 814 are
clamped off and connected to a vacuum pump, which is then turned
on. When the pump is stabilized at full vacuum, (between
approximately 25 inHg-30 inHg, preferably 27 inHg-29.5 inHg), the
stomach is slowly desufflated and then the vacuum tubes 814, 816
are opened to acquire tissue in each opening 741, 743 of the
cartridge and anvil members 732, 734. It is preferred that the
vacuum tubes 814, 816 are opened simultaneously, however, the
vacuum tubes may be opened at different times as well. The extended
sail 744 and septum 736 organize the target tissue into the
appropriate member 732, 734. FIG. 49A depicts a cross-sectional
view taken along line 49a-49a of FIG. 49, with folds of tissue
being acquired in the openings 741,743. At this point, the members
732, 734 are lightly clamped together by rotating the clamp/open
knob 832 in a clockwise direction. It may be desired to clamp off
the vacuum tubes 814, 816 and then insufflate the stomach to view
the acquired tissue that is being held with the members 732, 734.
It is desirable that the acquired tissue have no large folds or
pleats so that a smooth double sleeve can be formed with the
device.
[0158] The stomach may then be desufflated once again and the
vacuum tubes 814, 816 are unclamped to re-apply vacuum that holds
the tissue within the openings of the members 732, 734. Next, the
retractor wire 742 is retracted almost completely, until the first
end 746 is near the distal tip 740 and the sail is collapsed as
shown in FIG. 50. The members 732, 734 are unclamped by rotating
the clamp/open knob 832 counterclockwise, and the septum 736 is
ejected from between the members. The septum is ejected by
unlocking the septum push-off knob 842, sliding the knob 842 about
an inch back or proximally in the groove 840, tightening the knob
842 to capture a septum wire 844, and sliding the knob 842 forward
to advance the septum distally. This procedure is repeated until
the septum 736 is fully advance away from the tissue treatment
device 712 as shown in FIG. 51. Once again, the members 732, 734
may be lightly clamped together, the vacuum lines 814, 816 are
clamped off, and the stomach is insufflated to inspect the clamp
tissue to ensure the septum 736 is clear of the targeted tissue and
that no large tissue folds of pleats are present in the clamp line,
and that the sleeve staple line does not show signs of a large
proximal stoma. If the appearance of the acquired tissue is
acceptable, the stomach cavity is desufflated and the vacuum lines
814, 816 are unclamped to re-apply vacuum. After desufflation, the
members 732, 734 are fully clamped together using the clamp/open
knob 832. With tissue clamped between the members of the tissue
treatment device 712, the dual folds of the tissue are stapled
together by rotating the wedge fire knob 834 clockwise, which moves
the wedge 788 proximally within the cartridge member 732 to fire
the rows of staples. FIG. 5 1A depicts a cross-sectional view taken
along line 51a-51a of FIG. 51, and shows the two folds of tissue
being stapled together with the tissue treatment device. Once
completed, the jaws of the tissue treatment device 712 are opened
by rotating the clamp/open knob counterclockwise, and the vacuum
pump connected to tubes 814, 816 is turned off. To remove the
acquired tissue from the tissue treatment device, the acquired
tissue may be flushed from the openings 741, 743 of the members
732, 734 with a sterile water bolus delivered via vacuum tubes 814,
816 with a syringe. Once the tissue is freed from the tissue
treatment device, the endoscope EN is straightened as shown in FIG.
52, and the members 732, 734 are closed together with the septum
still in the trailing position. The endoscope is removed from the
gastroplasty assembly 700, and then the entire assembly is removed
from the stomach cavity, leaving a sleeve 846 within the stomach as
shown in FIGS. 53 and 53A.
[0159] If a long sleeve, two or more sleeves or staple lines, is to
be disposed within the stomach cavity, the removable staple
cartridge 768 can be replaced with a fresh staple cartridge, as
described above, and the entire procedure can be repeated to form
another sleeve. It is preferred that there are no gaps between
individual staple lines that form a long sleeve, and in one
embodiment the staple lines of a long sleeve may be overlapped (end
to end) to minimize gaps between staple lines.
[0160] Also, it is possible to reload the tissue treatment device
712 of the gastroplasty assembly 700 and then turn the tissue
treatment device towards the lesser curve of the stomach to form a
dual fold staple line down the lesser curve of the stomach. This
procedure will narrow the sleeve formed by the two dual fold staple
lines. In yet another embodiment, the tissue treatment device 712
can be used to form a single fold staple line within the stomach
cavity. In this embodiment, after forming a dual fold staple line,
the tissue treatment device may be turned toward the lesser curve
of the stomach to form another staple line. However, in this
embodiment, a vacuum is only created in one of the vacuum openings
741 or 743 so that only one fold of tissue is acquired and then
stapled to form a single fold staple line. This single fold staple
line may be used to further restrict the sleeve formed by the
initial dual fold staple line.
[0161] After forming plications within the stomach cavity using the
gastroplasty device 700, a restrictor stapler 900 can then be used
to perform a secondary step in a gastric sleeve or pouch formation
procedure. The restrictor stapler may be similar to the endoscopic
stapler described in U.S. patent application Ser. No. 11/107,382,
which is incorporated by reference in its entirety. There are
multiple uses for the restrictor stapler, such as forming
additional plications in the distal end of a gastric sleeve, and in
some situations close a stoma or fistula created by a gastric
sleeve.
[0162] Referring to FIG. 54, the restrictor stapler 900 includes a
stapler assembly 902 or cartridge assembly connected via a flexible
shaft 904 or elongated body having a proximal end and a distal end
to a stapler handle 906. The stapler assembly includes a fixation
member having a staple cartridge member 908, within which one or
more staples are housed, and an anvil 910 in apposition to stapler
cartridge member used to provide a staple closure surface when
tissue to be affixed is adequately positioned between staple
cartridge member and anvil. An optional smooth rubber tip 912 with
a guide wire channel 914 may be attached to the distal end of the
staple cartridge member. The atraumatic tip 912 prevents injury to
tissue when the device is advanced down the esophagus, and the
guide wire channel allows the fixation assembly to track down a
guide wire. The staple assembly also includes an acquisition member
for acquiring tissue. In one embodiment a vacuum pod 916 is
attached or integrated into the staple cartridge member 908, and a
vacuum line or tubing 917 extends from the vacuum pod, along the
shaft 904 and to the handle 906. It is preferred that the overall
insertion diameter of the stapler assembly and flexible shaft plus
endoscope is equal to or less than 54 Fr. In one embodiment, with
the jaws 908, 910 closed, the maximum perimeter of the device is
equivalent to about 15.1 mm diameter (0.595 inch or 45 Fr
diameter). With the jaws 908, 910 opened, the maximum perimeter of
the device is equivalent to about 17 mm diameter (0.668 inch or 51
Fr diameter).
[0163] With stapler assembly 902 connected at the distal end of
flexible shaft 904, the handle 906 is connected at the proximal end
of shaft. The flexible shaft 554 is configured to be curved, and in
one embodiment can achieve a 4 inch bend radius with a low
application of force. The handle 906 may include a housing and grip
920 in apposition to an actuation handle 922. In use, the handle
906 allows the surgeon or user to hold and manipulate the
restrictor stapler 900 with grip 920 while articulating stapler
assembly 902 between an open and close configuration via the
actuation handle 922. A lever or staple deployment actuator 924 is
also disposed on the handle 906 and is used to deploy staples from
the stapler assembly 902. Moreover, the configuration of the handle
906 allows the surgeon or user to articulate the stapler assembly
902.
[0164] In one embodiment, the anvil 910 may be pivotally connected
via a pivot 926 to the end of flexible shaft 904 as shown in FIG.
54A. The staple cartridge member 908 may be configured to remain
stationary relative to the flexible shaft 904 while anvil 910 may
be manipulated into an open and closed configuration with respect
to flexible shaft and staple cartridge member. However, in another
embodiment, the staple cartridge member may be pivotally connected
to the flexible shaft and the anvil remains stationary. In yet
another embodiment, both the anvil and the staple cartridge member
can pivot into an open and closed configuration relative to the
flexible shaft. To manipulate the anvil 560 to an open and closed
configuration, a circular or disk-shaped cam may be pivotally
attached about rotational pivot located on the side of the proximal
end of stapler assembly 902, as described with reference to FIG. 31
in U.S. patent application Ser. No. 11/107382. Actuation wires or
cables may be wound about cam such that when cable is pulled, cam
is urged to rotate clock-wise about rotational pivot. Actuation
cables may be manipulated from their proximal ends by the user. As
cam is rotated in a clock-wise direction, a portion of staple
cartridge member 908 may be engaged by the cam thereby forcing the
anvil 910 to pivot into an open configuration. An additional cam
may also be affixed on the opposite side of stapler assembly 902
such that dual cams are configured to open and close simultaneously
in parallel. As shown in FIG. 54B, when dual cams are used and the
jaws 908, 910 are opened, the surfaces of the jaws 908, 910 remain
parallel to one another. This allows for better tissue acquisition
between the jaws 908, 910.
[0165] In one embodiment as shown in FIG. 54C, the anvil 910
includes an anvil extension 928 disposed at the distal end of the
anvil. The anvil extension contacts the ceiling of a pocket 930
disposed in the proximal end of the rubber tip 912 as shown in FIG.
54D. This keeps the distal end of the anvil in plane and forces the
stapler cartridge 908 and anvil 910 to open in parallel as shown in
FIG. 54B. Referring to FIG. 54C, the staple cartridge member 908
includes a cartridge extension 932 that engages a cutout 934 (see
FIG. 54E) located at the proximal end of the rubber 912 to secure
the rubber tip to the stapler assembly 902.
[0166] In one embodiment of the restrictor stapler 900, there are
two rows of staple apertures 936 defined over the surface of the
staple cartridge member 908, as best shown in FIG. 54D. Staples are
deployed through the apertures in a similar manner as described
with reference to FIGS. 22A to 23C of U.S. patent application Ser.
No. 11/107,382, by pulling a staple actuation wire that in turn
moves a wedge in contact with a staple pusher to fire a staple. In
this embodiment, the lever or staple deployment actuator 924 is
depressed to pull the actuation wire in order to fire the staples
from the stapler assembly. The jaws 908, 910 of the stapler
assembly 902 are closed, as shown in FIG. 54A, using the actuation
handle 922, and then the staples may be deployed into the acquired
tissue. Other variations may utilize fewer or greater than two rows
of staple apertures.
[0167] In one embodiment of the restrictor stapler 900, the staple
cartridge member 908 can be re-loaded with a removable staple
cartridge 938. As shown in FIG. 54E, the removable staple cartridge
may be integrated with the rubber tip 912, so that they are loaded
and unloaded from the staple cartridge member 908 together. The
removable staple cartridge 938 includes a detent pin 940 located
near its distal end, that when placed into the staple cartridge
member 908, locks into a lock hole 942 located near the distal end
of the staple cartridge member. To load the removable staple
cartridge 938 into the restrictor stapler 900, the jaws 908,910 of
the stapler assembly 902 are opened, and the lever or staple
deployment actuator 924 is raised to push a staple firing wedge to
the distal end of the device. If the wedge does not travel to the
end of the device, the wedge may be manually pulled using forceps.
In one embodiment, firing cable struts can be disengaged from the
lever and the lever can be lowered without moving the wedge from
the distal location. The proximal end of the removable staple
cartridge 938 may be inserted into the staple cartridge member 908
and slid back, ensuring wedge does not pre-fire the staples. Once
the removable staple cartridge 938 is about 90% in place, the jaws
of the stapler assembly are slowly closed to allow the anvil
extension 928 to nest in the pocket 930 of the rubber tip. The
removable staple cartridge 938 is then pushed down and back to
ensure it is completely in the staple cartridge member 908, and the
jaws 908, 910 are completely closed. As the rubber tip/removable
staple cartridge are loaded onto the stapler assembly 902,
cartridge extension 932 will engage the cutout 934 of the rubber
tip 912 and the anvil extension 928 will fit into the pocket 930 of
the rubber tip, and the detent pin 940 will snap into the lock hole
942. To unload or remove the rubber tip/removable staple cartridge,
the jaws are opened and the detent pin 940 is pushed away from the
lock hole 942 and the rubber tip/removable staple cartridge is
removed by the user. The removable staple cartridges 938 may
include two rows of six staples, each having 4.8 mm leg length with
3 mm backspan. The staple line length in this embodiment is about
25.0 mm (0.984 inch), although the length of the staple line may
range from about 12.5 mm (0.492 inch) to about 50.0 mm (1.97
inch).
[0168] Generally, as shown in FIG. 55 the restrictor stapler 900 is
advanced over a guide wire through the guide wire channel 914 of
the rubber tip 912 and down the esophagus to the stomach cavity,
the stapler assembly 902 is preferably in a closed configuration.
Further, the restrictor stapler may be compatible with the
side-by-side insertion of a 8.6 mm diameter flexible endoscope EN
or similar scope. The device will be axially located by referencing
external markings on the shaft of the device, or visually by using
markings on the head of the stapler assembly 902 relative to the
"z-line." In terms of radial location, the device will be rotated
and placed while under direct visualization. Alternatively, the
user may rely on markings on the handle to rotationally orient the
device. Once the stapler assembly 902 is in the desired position
within the stomach cavity for placing a plication along the stomach
wall, the guide wire is removed, and the stapler assembly may be
articulated into an open configuration as shown in FIG. 54B. A
vacuum may then be created at the vacuum pod 916 to acquire a fold
of tissue 918 between the staple cartridge member 908 and the anvil
910. It is preferred that a vacuum device be used to achieve a
vacuum level of about 27 inHg to about 29.5 inHg. After the vacuum
level has stabilized, the jaws of the stapler assembly 902 are then
clamped closed over the tissue as shown in FIG. 56. The vacuum
created at the vacuum pod 916 is shut-off, and the stomach cavity
is insufflated to inspect and verify that the restrictor stapler is
in the desired position relative to the distal end of the sleeve.
If the position is acceptable, the stomach cavity is desufflated
and vacuum is again created at the vacuum pod. The jaws of the
stapler assembly 902 are then fully opened to complete the tissue
acquisition and then held until the vacuum stabilizes. Once
stabilized, the jaws of the stapler assembly are then clamped
closed over the tissue. It is preferred that the user waits fifteen
seconds and then the staples are deployed into the acquired tissue
to form a single fold plication. Vacuum is then released and the
stapler assembly 902 is opened and the device is slightly advanced
and rotated to allow for the gastric tissue to pull free from the
vacuum pod, or vacuum may be reversed to expel the tissue from the
pod. Once the tissue is free, the device is withdrawn leaving the
geometry shown in FIGS. 57 and 57A, which is a cross-sectional view
taken along line 57a-57b of FIG. 57. FIG. 57 is an illustrative
view showing the longitudinal plication or dual fold sleeve 846 and
the single fold of tissue 918 created by the restrictor stapler 900
to decrease the diameter of the distal stoma DS. The staple
cartridge member may be reloaded with another removable staple
cartridge 940 for another firing if necessary. Multiple plications
may be positioned using the restrictor stapler 900 anywhere within
the stomach cavity or newly created gastric sleeve or pouch. For
example, three additional single folds of tissue 918 may be created
near the distal stoma created by the dual fold sleeve 846 as shown
in FIG. 58.
[0169] By placing a single fold plication at the distal stoma of a
sleeve, the restrictor stapler 900 may reduce the diameter of the
distal stoma from about 0.5 cm to about 1.5 cm. For example, in a
wet lab test using canine tissue, a 19 mm diameter sleeve (57 Fr or
0.75 inch diameter) was reduced to 11.7 mm diameter (35 Fr or 0.46
inch diameter) by placing two restrictor plications adjacent to
each other at the distal end of the 19 mm diameter sleeve.
Therefore, these two restrictor plications removed 7.3 mm (22 Fr or
0.29 inch) from the sleeve diameter. The final size of the distal
stoma was smaller than the perimeter of the stapler assembly. In a
further example, the restrictor stapler places a plication that
takes-up 15 mm (0.59 inches) of linear tissue. This would yield a
4.8 mm diameter reduction (14.3 Fr or 0.188 inch diameter).
[0170] The gastroplasty device 700 and the restrictor stapler 900
can be used together to form a variety of geometries, some of which
are disclosed in U.S. patent application Ser. No. 11/107,382, which
has already been incorporated by reference. In addition, multiple
dual fold sleeves 846 may be placed consecutively in the stomach
cavity to form a longer gastric sleeve, and multiple single folds
of tissue 918 can be positioned within the longer gastric sleeve to
reduce the diameter of the stoma. For example, FIG. 59 depicts two
dual fold sleeves 846 placed consecutively in the stomach cavity,
with two single folds of tissue 918 each placed near the distal end
of the individual sleeves 846. FIG. 60 depicts three consecutively
placed sleeves 846 and three single folds of tissue 918 each placed
near the dial end of the individual sleeves 846. Although not
shown, the single folds of tissue 918 can be placed anywhere along
the lesser curve LC or circumferentially within the formed pouch to
further restrict the diameter of the pouch. In another example as
shown in FIG. 61, multiple sleeves 846 have been created within the
stomach cavity from the GEJ to the pylorus. No single folds of
tissue are shown in this example, however, it may be desirable to
place multiple single folds of tissue along the lesser curve LC of
the stomach.
[0171] In other embodiments, the distal stoma DS of the gastric
sleeve or pouch may be further restricted by cinching the distal
stoma together as disclosed in U.S. patent application Ser. No.
11/056,327, which is hereby incorporated by reference in its
entirety. In this embodiment, anchors may be placed
circumferentially around the distal stoma, and then cinched
together using a wire attached to all of the anchors. In another
embodiment, an intragastric band may be placed at the distal stoma
to further reduce its diameter as described in U.S. patent
application Ser. No. 11/067,598, which is hereby incorporated by
reference in its entirety. Here, the intragastric band is attached
circumferentially around the distal stoma, and then the band itself
cinches the distal stoma. It should be recognized that once the
gastric sleeve or pouch is created, many methods may used to
further restrict the diameter of the distal stoma created by the
sleeve or pouch.
[0172] Referring now to FIGS. 62 through 65, another embodiment of
a tissue treatment device 712 is shown to include a distal clamping
cable 950 to help close or clamp the members 732, 734 together. In
the embodiment shown, a proximal end of the distal clamping cable
950 is attached at the handle 710 and a distal end of the distal
clamping cable is attached to the distal end of the tissue
treatment device. As shown in FIG. 62, cartridge vacuum tube 812
and anvil vacuum tube 814 may be routed through elongate member 702
into a proximal end cap 952 of each cartridge member 732 and anvil
member 734 for fluid connection with respective openings 741, 743.
Proximal outer clamping cable 816 and proximal inner clamping cable
818 may be passed through elongate member 702 around proximal
vertical pulleys 817 in the cartridge member 732 and across to the
anvil member 734 where the ends may be held in the anvil member
with ball crimps. FIG. 64 shows the proximal end of the tissue
treatment device with the proximal end cap 952 removed showing the
proximal vertical pulleys 817, and the proximal inner and outer
clamping cables 816, 818 including coilpipes 958. In this
embodiment, the distal clamping cable 950 is also passed through
the elongate member 702 into the tissue treatment device 712 around
a distal vertical pulley 954 in a distal end cap 956 of the
cartridge member 732 and across to the anvil member 734 where the
end may be held in the anvil member with a ball crimp. FIG. 63
shows the distal end of the tissue treatment device with the distal
end cap 956 removed to show the distal vertical pulley 954. To
clamp cartridge member 732 and anvil member 734 closed, cables 816,
818 and 950 are pulled proximately. While the proximal cables 816
and 818 provide a clamping force at the proximal end of the tissue
treatment device, the distal cable 950 provides a clamping force at
the distal end of the tissue treatment device to provide a more
even clamping force across the entire length of the tissue
treatment device. Proximal opening cable 822 may be passed through
elongate member 702 around the proximal horizontal pulley as
discussed above with reference to FIGS. 43 and 44.
[0173] In another embodiment, one of the proximal clamping cables
816 or 818 can be re-routed to the distal vertical pulley 954 to
become the distal clamping cable 950. This embodiment still
provides a clamping force at the distal end of the tissue treatment
device without having to add an additional cable to the system.
Further, by not adding an additional cable, the mechanism in the
handle assembly 710 would be the same as disclosed above with
reference to FIGS. 46A and 46B.
[0174] In describing the system and its components, certain terms
have been used for understanding, brevity, and clarity. They are
primarily used for descriptive purposes and are intended to be used
broadly and construed in the same manner. Having now described the
invention and its method of use, it should be appreciated that
reasonable mechanical and operational equivalents would be apparent
to those skilled in this art. Those variations are considered to be
within the equivalence of the claims appended to the
specification.
* * * * *