U.S. patent application number 12/053257 was filed with the patent office on 2009-09-24 for endoscopic stapling devices and methods.
Invention is credited to DAVID COLE, Andrew Smith.
Application Number | 20090236401 12/053257 |
Document ID | / |
Family ID | 40719922 |
Filed Date | 2009-09-24 |
United States Patent
Application |
20090236401 |
Kind Code |
A1 |
COLE; DAVID ; et
al. |
September 24, 2009 |
ENDOSCOPIC STAPLING DEVICES AND METHODS
Abstract
Described herein are endoscopic staplers used to apply one or
more fasteners to body tissue. In one embodiment, a
fastener-applying device, which is preferably a stapler, is passed
transorally into the stomach and used to plicate stomach tissue by
engaging tissue from inside of the stomach and drawing it inwardly.
In the disclosed embodiments, the tissue is drawn inwardly into a
vacuum chamber, causing sections of serosal tissue on the exterior
of the stomach to be positioned facing one another. The disclosed
staplers allow the opposed sections of tissue to be moved into
contact with one another, and preferably deliver staples for
maintaining contact between the tissue sections at least until
serosal bonds form between them. Each of these steps may be
performed wholly from the inside of the stomach and thus can
eliminate the need for any surgical or laparoscopic intervention.
After one or more plications are formed, medical devices may
optionally be coupled to the plication(s) for retention within the
stomach.
Inventors: |
COLE; DAVID; (San Mateo,
CA) ; Smith; Andrew; (San Francisco, CA) |
Correspondence
Address: |
King & Spalding LLP
P.O. Box 889
Belmont
CA
94002-0889
US
|
Family ID: |
40719922 |
Appl. No.: |
12/053257 |
Filed: |
March 21, 2008 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12050169 |
Mar 18, 2008 |
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12053257 |
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Current U.S.
Class: |
227/180.1 ;
227/176.1; 606/170 |
Current CPC
Class: |
A61B 17/32053 20130101;
A61B 17/115 20130101; A61B 2017/306 20130101; A61F 5/0013 20130101;
A61B 17/064 20130101; A61F 5/0083 20130101; A61B 17/072 20130101;
A61B 2017/00539 20130101; A61B 2017/07271 20130101; A61B 2017/00818
20130101 |
Class at
Publication: |
227/180.1 ;
227/176.1; 606/170 |
International
Class: |
A61B 17/068 20060101
A61B017/068; A61B 17/32 20060101 A61B017/32 |
Claims
1-218. (canceled)
219. A staple holder for housing medical staples, the staple holder
comprising: a body including a plurality of pedal sections, each
pedal section including a slot containing a staple.
220. The staple holder of claim 219, wherein the pedal section
includes an outer wall portion and a retaining element coupled to
the outer wall portion to define the slot.
221. The staple holder of claim 220 wherein the retaining element
includes a pair of wings, each wing extending from an opposite end
of the outer wall portion.
222. The staple holder of claim 219, wherein the plurality of pedal
sections extend radially from the body.
223. The staple holder of claim 222, wherein the pedal sections
define an outer ring of staple slots, and wherein the body includes
an inner ring of inner staple slots concentrically arranged with
the outer ring.
224. The staple holder of claim 223, further including longitudinal
wall sections disposed between the pedal sections, and second
retaining elements extending inwardly from the longitudinal wall
sections to define the inner staple slots.
225. The staple holder of claim 224, wherein the second retaining
elements each include a pair of wings, each wing extending from an
opposite end of the longitudinal wall section.
226. A staple anvil, comprising: a body including a plurality of
pedal sections extending radially from the body, each pedal section
including a pair of staple-folding recesses.
227. The staple anvil according to claim 226, wherein the staple
folding recesses define an outer ring of staple folding recesses,
and wherein the staple anvil further includes an inner ring of
staple folding recesses concentrically arranged with the outer
ring.
228. A stapler, including: staple holder comprising a body
including a plurality of pedal sections, each pedal section
including a slot containing a staple; and an anvil, comprising a
body including a plurality of pedal sections extending radially
from the body, each pedal section including a pair of
staple-folding recesses; and a staple driver advanceable at least
partially through the staple holder.
229. The stapler of claim 228, wherein the pedal sections of the
staple holder are aligned such that advancement of a staple from a
slot in a first pedal section of the staple holder will advance the
staple into contact with staple-folding recesses of a corresponding
pedal sections of the anvil.
230. The stapler of claim 229, wherein the pedal sections define an
outer ring of staple slots, and wherein the body includes an inner
ring of inner staple slots concentrically arranged with the outer
ring.
231. The stapler of claim 230, wherein the staple folding recesses
define an outer ring of staple folding recesses, and wherein the
staple anvil further includes an inner ring of staple folding
recesses concentrically arranged with the outer.
232. A medical cutting device, comprising: a cutting element having
a distal tip; and a cutting board having a face, the distal tip and
face spaced-apart by a first distance to define a tissue receiving
area, the cutting element advanceable in a distal direction into
contact with the face to cause cutting of tissue in the receiving
area, the face adaptable to permit advancement of the distal tip by
an amount greater than the first distance.
233. The medical cutting device of claim 232, wherein the first
distance is a fixed distance, and wherein the face cutting board is
formed of a material capable of penetration by the cutting
element.
234. The medical cutting device of claim 232, wherein the cutting
board is mounted to a housing, the cutting board deflectable
relative to the housing such that movement of the cutting element
into contact with the cutting board deflects the cutting board in
the distal direction.
235. The medical cutting device of claim 234, further including a
spring element positioned between the cutting board and the housing
such that movement of the cutting element into contact with the
cutting board causes the cutting board to compress the spring
element.
236. The medical cutting device of claim 235, wherein the spring
element is an elastomeric element.
237. The medical cutting device of claim 232 wherein the cutting
element is a tubular cutting element.
238. The medical cutting device of claim 237, wherein the cutting
board includes a central opening.
239. The medical cutting device of claim 232, wherein the medical
cutting device is a medical stapling and cutting device, and
wherein the device further includes: a head including: a first
member, a staple holder carrying at least one fastening positioned
on the first member, a staple driver advanceable through the staple
holder, wherein the cutting element is positioned on the first
member; and a second member and an anvil positioned on the first
member, wherein the cutting board is positioned on the second
member.
240. The device of claim 239, wherein the cutting element is
coupled to the fastener driver, such that advancement of the staple
driver advances the cutting element through the tissue receiving
area.
241. A method of cutting tissue, comprising: providing a cutting
device comprising a tissue cutting element, a cutting board having
a face spaced from the cutting device by a first distance to define
a tissue receiving area between the cutting element and the cutting
board; positioning tissue in the tissue receiving area; advancing
the cutting element through the tissue and into contact with the
cutting board, and causing the cutting board to permit advancement
of the distal tip by an amount greater than the first distance.
242. The method of claim 241, wherein the first distance is a fixed
distance, and wherein causing the cutting board to permit
advancement includes causing the cutting element to penetrate the
cutting board.
243. The method of claim 241, wherein causing the cutting board to
permit advancement includes causing the cutting board to deflect.
Description
FIELD OF THE INVENTION
[0001] The present invention relates generally to the field of
systems and methods for performing endoscopic surgery, and
specifically to systems and methods for endoscopic stapling of
tissue within body cavities.
BACKGROUND OF THE INVENTION
[0002] An anatomical view of a human stomach S and associated
features is shown in FIG. 1A. The esophagus E delivers food from
the mouth to the proximal portion of the stomach S. The z-line or
gastro-esophageal junction Z is the irregularly-shaped border
between the thin tissue of the esophagus and the thicker tissue of
the stomach wall. The gastro-esophageal junction region G is the
region encompassing the distal portion of the esophagus E, the
z-line, and the proximal portion of the stomach S.
[0003] Stomach S includes a fundus F at its proximal end and an
antrum A at its distal end. Antrum A feeds into the pylorus P which
attaches to the duodenum D, the proximal region of the small
intestine. Within the pylorus P is a sphincter that prevents
backflow of food from the duodenum D into the stomach. The middle
region of the small intestine, positioned distally of the duodenum
D, is the jejunum J.
[0004] FIG. 1B illustrates the tissue layers forming the stomach
wall. The outermost layer is the serosal layer or "serosa" S and
the innermost layer, lining the stomach interior, is the mucosal
layer or "mucosa" MUC. The submucosa SM and the multi-layer
muscularis M lie between the mucosa and the serosa.
[0005] There are a number of applications for endoscopic
application of fasteners such as staples to tissue within a body
cavity. Some of those applications involve forming tissue
structures such as plications or folds in tissue of the body
cavity.
[0006] Several prior applications, including International
Application No. WO 2005/037152 having an international filing date
of Oct. 8, 2004 and U.S. application Ser. No. 11/439,461, filed May
23, 2006 (both incorporated herein by reference) describe methods
according to which medical implants are coupled to tissue
structures formed within the stomach. According to these
applications, devices for inducing weight loss (e.g. by restricting
and/or obstructing flow of food into the stomach, and/or by
occupying a portion of the stomach volume) may be coupled to tissue
tunnels or plications formed from stomach tissue.
[0007] For example, U.S. application Ser. No. 11/439,461 describes
a restrictive and/or obstructive implant system for inducing weight
loss. In one embodiment, flexible loops are coupled to tissue
plications formed in the gastroesophageal junction region of the
stomach. An implant, such as a flow restrictive and/or obstructive
implant, is passed through the loops 2 and thus retained in the
stomach.
[0008] In other instances, tissue plications may themselves be
sufficient to provide the necessary treatment. For example, the
plications may be used to reduce stomach volume or form a flow
restriction within the stomach as disclosed in WO 2005/037152 and
in Applicants' co-pending application Ser. No. 11/542,457, filed
Oct. 3, 2006, U.S. Publication No. 2007-0219571, which is
incorporated herein by reference.
[0009] Other types of implants may be coupled to such plications or
other tissue structures for a variety of purposes. These implants
include, but are not limited to prosthetic valves for the treatment
of gastro-esophageal reflux disease, gastric stimulators, pH
monitors and drug eluting devices that release drugs, biologics or
cells into the stomach or elsewhere in the GI tract. Such drug
eluting devices might include those which release leptin (a hormone
which creates feelings of satiety), Ghrelin (a hormone which
creates feelings of hunger), octreotide (which reduces Ghrelin
levels and thus reduces hunger), Insulin, chemotherapeutic agents,
natural biologics (e.g. growth factor, cytokines) which aid in post
surgery trauma, ulcers, lacerations etc. Still other implants might
be of a type which might provide a platform to which specific cell
types can adhere, grow and provide biologically-active gene
products to the GI tract, and/or a platform for radiation sources
that can provide a local source of radiation for therapeutic
purposes, or provide a platform whereby diagnostic ligands are
immobilized and used to sample the GI tract for evidence of
specific normal or pathological conditions, or provide an anchor
point for imaging the GI tract via cameras and other image
collecting devices.
[0010] The prior applications listed above, address the
desirability of forming tissue plications, pockets or tunnels in a
way that regions of serosal tissue (i.e. the tissue on the exterior
surface of the stomach) are retained in contact with one another.
Over time, adhesions formed between the opposed serosal layers
create strong bonds that can facilitate retention of the
plication/pocket/tissue over extended durations, despite the forces
imparted on them by stomach movement and implanted devices.
[0011] Regardless of the application for which a plication is being
formed, it is highly desirable to form that plication using steps
carried out from within the stomach using instruments passed down
the esophagus, rather than using more invasive surgical or
laparoscopic methods. The present application describes endoscopic
staplers which may be passed transorally into the stomach and used
to form serosal-to-serosal plications in a stomach wall.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] FIG. 1A is a schematic illustration of a human stomach and a
portion of the small intestine.
[0013] FIG. 1B is a cross-sectional perspective view of a portion
of a stomach wall, illustrating the layers of tissue forming the
wall.
[0014] FIG. 2 illustrates an endoscopic stapling system.
[0015] FIGS. 3A-3C are perspective views showing the stapler head
of the stapling system of FIG. 2 in three different positions.
[0016] FIG. 4 is a perspective view of the stapler head, with the
membrane removed.
[0017] FIG. 5 is a perspective view of the proximal end of the
staple housing of the stapler head of FIG. 4.
[0018] FIG. 6 is a perspective view of the distal end of the staple
housing of the stapler head of FIG. 4.
[0019] FIG. 7 is an exploded perspective view showing elements
advanceable within the staple housing during compression and
stapling operations.
[0020] FIG. 8 is a plan view of a staple reinforcement device.
[0021] FIG. 9 is a side elevation view of a staple cartridge.
[0022] FIG. 10 is a perspective view of the staple housing similar
to FIG. 6, but showing some of the elements of FIG. 7 within the
housing.
[0023] FIGS. 11A-11D are a series of schematic representations of
the hydraulic chamber and pistons, illustrating operation of an
exemplary hydraulic system during tissue compression and
stapling.
[0024] FIG. 11E is similar to FIG. 11D and shows an alternative
piston configuration.
[0025] FIG. 12 is a perspective view of the anvil housing of the
stapler head of FIG. 4.
[0026] FIG. 13 is a perspective view of the anvil support.
[0027] FIG. 14 is a plan view of the anvil.
[0028] FIG. 15A is a cross-sectional side view of the cutting
device and a first embodiment of a cutting board.
[0029] FIG. 15B is a cross-sectional side view of the cutting
device and a second embodiment of a cutting board.
[0030] FIG. 16 is a perspective view of the hinged arm assemblies
of the stapler head of FIG. 4.
[0031] FIG. 17 is a top plan view of the stapler head of FIG. 4 in
the streamlined position for introduction into the body. Both the
membrane and the membrane raiser are not shown for purposes of
clarity.
[0032] FIG. 18 is similar to FIG. 17 and illustrates hidden
features of FIG. 17.
[0033] FIG. 19 is a perspective view of the stapler head in an
intermediate, partially expanded, position.
[0034] FIG. 20 is a plan view similar to FIG. 17 but showing the
stapler head in the intermediate position.
[0035] FIG. 21 is similar to FIG. 20 and illustrates hidden
features of FIG. 20.
[0036] FIG. 22 is a perspective view of the stapler head in a fully
expanded, full compression position.
[0037] FIG. 23 is a plan view similar to FIG. 20 but showing the
stapler head in the full compression position.
[0038] FIG. 24 is similar to FIG. 23 and illustrates hidden
features of FIG. 24.
[0039] FIGS. 25A-25B are perspective views showing the staple
housing, cartridge and a portion of the membrane raiser. These
figures illustrate the steps of detaching a staple cartridge from
the staple housing.
[0040] FIG. 26 is a perspective view of the stapler of FIG. 2, with
the staple head removed.
[0041] FIG. 27A is a plan view of the articulating section of the
stapler of FIG. 2, showing the drive fluid lines.
[0042] FIG. 27B shows a drive fluid line having an alternate
longitudinally expandable shape.
[0043] FIG. 28 is a cross-sectional side view of the handle of the
stapler of FIG. 2.
[0044] FIG. 29 is a perspective view of the handle of the stapler
of FIG. 2.
[0045] FIGS. 30A and 30B are plan views of the proximal face of the
staple housing, showing a method for attaching the end plate of the
stapler handle to the staple housing.
[0046] FIGS. 31A-31E are a series of drawings schematically
illustrating use of the system of FIG. 2 to form a plication in a
stomach.
[0047] FIGS. 32A-32C are a series of perspective views illustrating
use of the stapler of FIG. 2 to acquire, compress, and then staple
stomach wall tissue to form a plication in the stomach. The
membrane is not shown in these drawings.
[0048] FIG. 33 is a top plan view of a plication formed in body
tissue.
[0049] FIGS. 34 and 35 are perspective views of an alternative
stapler head equipped to carry additional tools.
DETAILED DESCRIPTION OF THE DRAWINGS
[0050] The present application describes endoscopic
fastener-applying devices which in preferred embodiments may be
passed transorally into the stomach and used to plicate stomach
tissue.
[0051] In the disclosed embodiments, tissue is drawn inwardly into
a vacuum chamber, although tissue may be drawn inwardly using other
components (e.g. graspers) that do not involve the use of a vacuum.
When a portion the interior stomach wall is drawn inwardly,
sections of serosal tissue on the exterior of the stomach are
positioned facing one another. The disclosed fastener applying
device allows the opposed sections of tissue to be moved into
contact with one another, and delivers fasteners that will hold the
tissue sections together until at least such time as serosal bonds
form between them. Each of these steps may be performed wholly from
the inside of the stomach and thus can eliminate the need for any
surgical or laparoscopic intervention. After one or more plications
is formed, medical devices (including, but not limited to any of
the types listed above) may be coupled to the plication(s) for
retention within the stomach.
[0052] The disclosed embodiments include an optional feature that
forms a hole or cut in a plication using the fastener-applying
device. This hole or cut might be formed so that a portion of a
medical implant may be passed through or linked to the hole/cut, or
it may be formed so as to provoke a healing response that will
contribute to the strength of the resulting tissue bond.
[0053] In the description of the embodiments given below, the
fastener-applying devices are described as being staplers, and
exemplary methods are given with respect to the formation of
plications in stomach tissue. It should be understood, however,
that the embodiments described herein include features having equal
applicability for applying other types of fasteners, and for
applying staples or other fasteners for purposes other than
formation of plications. The disclosed embodiments and methods will
also find use in parts of the body outside the GI system.
Additionally, although the disclosed embodiment features circular
stapling and cutting of a concentric hole, modifications are
conceivable in which linear stapling can be accomplished, as well
as circular or linear stapling without cutting.
[0054] FIG. 2 illustrates one embodiment of a system 10 for tissue
stapling that is suitable for endoscopic use, as well as surgical
or laparoscopic use if desired.
[0055] Generally speaking, system 10 includes a stapler 12 having a
stapler head 14 positioned on a distal portion of a shaft 16. A
handle 18 on the shaft 16 controls articulation of the stapler head
14 and actuation of the tissue acquisition, tissue compression, and
stapling functions of the stapler head 14. Vacuum and fluid sources
20, 25 are fluidly coupled to the handle 18 for use in tissue
acquisition, compression and stapling as discussed below. The
vacuum source 20 may be the "house vacuum" accessible through a
coupling on the wall of the operating room, or an auxiliary suction
pump. The stapler may include a switch 21 allowing the user to
control airflow between the vacuum source and stapler.
[0056] The fluid source 25 may be a single source of drive fluid
(e.g. water, saline, oil, gas) or multiple sources, but in each
case the fluid source preferably includes two actuators separately
used to control flow into each of two hydraulic lines (one for
tissue compression and one for stapling). An endoscope 22
insertable through a lumen in the shaft 16 permits visualization of
the plication procedure. The system may optionally include an
overtube, such an endoscopic guide tube 23, having a lumen for
receiving the stapler 12.
[0057] Referring to FIG. 3A, a covering or membrane 24 encloses the
stapler head 14 to form a vacuum chamber within the stapler head
14. The side exposed to the tissue to be plicated remains uncovered
by the membrane 24 to allow tissue to be drawn into the chamber
during use. For example, the membrane 24 may include a side opening
26 as shown in FIG. 3B. Membrane 24 is preferably formed of
silicone, elastomeric material, or any other inelastic or elastic
flexible or deformable biocompatible material capable of forming a
vacuum chamber that will expand in volume to accommodate tissue
drawn into the chamber.
[0058] At least a portion of the membrane is at least partially
transparent. In being at least partially transparent, the membrane
is formed of a material, or includes sections of material, that
will allow the user to see through the membrane well enough to
confirm (via endoscopic observation) that an appropriate volume of
tissue has been acquired into the stapler head prior to staple
application. The opening 26 may be surrounded by a reinforced
section 27 formed of material that will strengthen the area around
the opening 26. Reinforced section 27 may be formed of a thicker
section of the membrane material, and/or a higher durometer
material. Alternatively, reinforcing ribs or other structures or
elements may be formed into or onto the membrane material, or
embedded in the membrane material.
[0059] Stapler Head
[0060] The stapler head 14 is designed to have a minimum profile
during insertion to the plication site, and to then transform into
a much larger profile device having a large internal volume. For
example, in one embodiment the vacuum chamber might have an initial
internal volume of 0.2 cubic inches, and an expanded volume of 0.6
cubic inches (i.e. the internal chamber volume after subtracting
the volume occupied by the stapler head components positioned
within the vacuum chamber). This large internal volume allows a
large volume of tissue to be drawn into the vacuum chamber and
stapled. In this way, the stapler head creates a large plication
without requiring invasive techniques for insertion. The unique
features of the stapler head allow in situ volumetric expansion of
the stapler head using a minimum of motion and force input.
[0061] Features of the stapler head are shown in FIGS. 4-10. For
clarity, the membrane is not shown in these figures. Referring to
FIG. 4, stapler head 14 generally includes a first member
comprising a proximal staple housing 28, a second member comprising
a distal anvil housing 30, and at least one elongate member but
preferably a pair of hinged arm assemblies 32.
[0062] The staple housing and anvil housing are arranged to allow
tissue to be compressed between contact surfaces on each of the
staple housing and the anvil housing. In the disclosed embodiment,
the contact surfaces are on a staple holding portion of the staple
housing and an anvil on the anvil housing.
[0063] The arm assemblies 32 extend between the staple housing 28
and anvil housing 30 on opposite sides of the stapler head 14.
Proximal and distal pins 34, 36 pivotally couple each arm assembly
32 to the staple housing 28 and the anvil housing 30. An expansion
member comprising a membrane raiser 37 also extends between the
staple housing 28 and the anvil housing 30. Although the membrane
24 is not shown in FIG. 4, it should be understood that the
membrane raiser 37 is positioned opposite the opening 26 (FIG. 3B)
in the membrane. In the illustrated embodiment, membrane raiser 37
includes a link 38 pivotally mounted to the staple housing by a pin
42, a corresponding link 40 pivotally mounted to the anvil housing
by pin 44, and spring wires 46 coupling the links 38, 40 to one
another.
[0064] Staple Housing
[0065] Turning to a more detailed discussion of the stapler head
components, the staple housing 28 can be seen separated from other
components in FIGS. 5 and 6. As shown in FIG. 5, proximal face 48
of the staple housing includes input ports 50a, 50b through which
fluid is directed for hydraulic actuation of the tissue
compression, stapling, and optional cutting operations of the
stapler head. Seals 51 surround the ports 50a, 50b to minimize
fluid leakage.
[0066] Vacuum ports 52 are fluidly coupled to a vacuum source 20
(FIG. 2) that is selectively activated to create negative pressure
in the vacuum chamber for tissue acquisition. The vacuum ports 52
are connected to the vacuum source 20 by flexible tubing (not
shown) in the stapler shaft 16 (FIG. 2). Mounting holes 54 are used
to mount the stapler head 14 to the shaft 16.
[0067] The staple housing 28 includes upper and lower sections 58a,
58b above and below open side sections 56. The upper section 58a
includes a recess 60 within which the pivot pin 42 for link 38
(FIG. 4) is mounted. As best shown in FIG. 6, bores 62 are
positioned in the upper and lower sections 58a, 58b to receive pins
34 (FIG. 4) that serve as the proximal pivot points for arm
assemblies 32. Guide slots 64 extend longitudinally through the
upper and lower sections 58a, 58b.
[0068] Referring to FIG. 6, a hydraulic chamber 66 is disposed
within the staple housing 28. Within the hydraulic chamber 66 (FIG.
6) is a dedicated hydraulic circuit for driving the tissue
compression and stapling functions of the stapler. Chamber 66 is
fluidly coupled to the fluid input ports 50a, 50b (FIG. 5). As will
be discussed in detail in connection with FIGS. 11A-11D, fluid
driven into the hydraulic chamber 66 via input ports 50a, 50b
sequentially advances a system of hydraulic pistons (not shown)
that act on other components to compress the tissue, and that drive
the staples and cutting element through the compressed tissue.
[0069] FIG. 7 illustrates components of the stapler head that are
driven by the hydraulic system for compression, stapling, and
cutting. For clarity, these components are shown separated from the
staple housing and from each other. In this discussion, the
components that are driven by the hydraulic system will be
described. The hydraulic system itself is described in a later
section in connection with FIGS. 11A-11D.
[0070] In particular, FIG. 7 illustrates a drive member which takes
the form of a disk 68 in the staple housing. In the assembled
housing, disk 68 is positioned such that it will be pushed distally
by a hydraulic compression piston (not shown). The drive member is
coupled to the arm assemblies 32, anvil housing, and staple housing
so that advancing the drive member distally effects tissue
compression by bringing the contact surfaces of the staple housing
and anvil housing relatively towards one another.
[0071] Disk 68 includes mounting bores 70, a central opening 72,
and alignment posts 74. Referring briefly to FIG. 10, in the
assembled stapler head, disk 68 is coupled to the stapler housing
28 using pins 84 that extend through the housing's guide slots 64
and through mounting bores 70 in the disk 68.
[0072] A portion of the staple housing 28 contains staples to be
fired into the tissue. The staples are contained within a staple
holder on the staple housing. The staple holder may have a number
of different configurations. For example, it may be an integral
portion of the staple housing, or a separate part mounted or
attached to the staple housing, and/or it may be moveable relative
to the body of the staple housing to effect tissue compression
prior to stapling. In any of these examples, the staple holder may
be a removeable/replaceable cartridge, and/or it may be refillable
by inserting additional staples into it. In other embodiments, the
staple holder may be neither replaceable nor refillable.
[0073] In the disclosed embodiment, the staple holder is a
removeable staple cartridge 78 that can be replaced with another
cartridge after staple filing. In this embodiment, the staple
cartridge is moveable relative to the body of the staple housing to
compress the tissue prior to staple firing.
[0074] Referring again to FIG. 7, staple cartridge 78 is
positionable within the staple housing, distal to the disk 68, such
that distal advancement of the disk by the compression piston
pushes the cartridge distally to compress tissue disposed between
the cartridge and anvil. Grooves 79 on the exterior of the
cartridge slide over corresponding ones of the alignment posts 74
during insertion of the cartridge into the stapler head. FIG. 10
shows the alignment posts prior to loading of a cartridge into the
staple housing. As shown, the alignment posts 74 may have tapered
ends to facilitate loading of the cartridge over the posts.
[0075] Again referring to FIG. 7, cartridge 78 includes a number of
staple locations 80, each housing a staple. The staple cartridge is
equipped with bosses 81 to retain a staple line reinforcement
device 83 of the type shown in FIG. 8 and disclosed in detail in
commonly-owned U.S. application Ser. No. 11/542,457, entitled
ENDOSCOPIC PLICATION DEVICES AND METHODS, filed Oct. 3, 2006, and
published Sep. 20, 2007 as US 2007-0219571. To summarize briefly,
this type of reinforcement device 83 may be a ring or other element
positionable against the distal face of the staple cartridge. When
the ring is placed on the cartridge, openings 85 in the ring align
with prongs of some of the staples in the cartridge. When staples
are driven from the cartridge, these prongs pass through associated
ones of the openings 85 and capture the ring 83 against the
adjacent body tissue.
[0076] Referring to FIGS. 7 and 9, a number of undercut bosses 81
on the anvil-facing side of the cartridge may be used to lock the
reinforcement device 83 in place on the face of the staple
cartridge. Other positive shapes, such as mushrooms, hooks, and
tilted bosses could be used to accomplish the same end. Negative
shapes, such as pockets or grooves formed into the surface of the
cartridge, may also be employed to engage corresponding features on
the reinforcement device 83. As another alternative, the
reinforcement device may be held in place on the cartridge using
adhesives.
[0077] A cutter element 86 extends through the central opening 72
(FIG. 7) of the disk 68. The cutter element is shown as a tubular
punch having a sharpened wall and a lumen 87, but may be provided
in alternative forms. A staple pusher 76 is mounted to the cutter
element, distally of the disk as can be seen in the assembled view
of FIG. 10. Staple pusher 76 includes pusher elements 82
proportioned to slide into the cartridge's staple locations 80 as
the staple pusher 76 is advanced into the staple cartridge 78, thus
driving the staples from the cartridge. A hydraulically-driven
staple piston (not shown in FIG. 7) in the hydraulic chamber 66 is
coupled to the cutter element 86 such that advancement of the
stapler piston advances the staple pusher 76 and cutter element 86
in a distal direction.
[0078] Fluid Drive System
[0079] The fluid drive system used to actuate compression, stapling
and cutting may be configured in various ways. The following
paragraphs describe one exemplary configuration for the fluid drive
system, which in this embodiment is a hydraulic system. FIGS. 11A
and 11B schematically show the fluid flow in the hydraulic chamber
66 of the staple housing 28 during both compression and stapling
stages of actuation. Referring to FIG. 11A, compression piston 106
is disposed within hydraulic chamber 66. Disk 68 (also shown in
FIGS. 7 and 10) is positioned in contact with or slightly distal to
piston 106. Compression piston 106 is generally cup-shaped, having
a rear wall 108 and a side wall 110 enclosing an interior 111.
O-ring seals 112 are spaced-apart on a proximal portion of the side
wall 110. Channels 114 are formed through the side wall 110,
between the o-ring seals 112.
[0080] A second piston, referred to as the staple piston 116, is
positioned in the interior 111 of compression piston 106, against
the rear wall 108. Although not shown in FIGS. 11A-11D, cutting
element 86 (FIG. 7), with the staple pusher 76 thereon, is
positioned in contact with or slightly distal to the staple piston
116. An o-ring seal 118 surrounds a portion of the staple piston
116 that is distal to the channels 114 in the compression
piston.
[0081] A first fluid channel 120 extends from fluid port 50a in the
stapler housing 28 to a proximal section of the hydraulic chamber
66. A second fluid channel 122 extends from fluid port 50b in the
stapler housing to a more distal section of the hydraulic chamber
66. Fluid flow from port 50a and fluid channel 120 against the
compression piston cylinder is shown in FIG. 11A. Fluid pressure
within the hydraulic chamber 66 advances the compression piston
106, with the stapler piston 116 within in it, in a distal
direction. FIG. 11B shows the compression piston 106 approaching
the end of its travel. Once the compression piston reaches the end
of its travel as shown in FIG. 11C, channel 114 in the compression
piston 106 aligns with channel 122 in the housing, allowing fluid
introduced through fluid port 50b to enter the interior of the
compression piston 106 via channel 122. The fluid entering the
interior of the compression piston drives the staple piston
distally as shown in FIG. 11D. In an alternative embodiment shown
in FIG. 11E, a third piston 117 is provided for separately driving
the cutting element 86. In this embodiment, fluid introduced into a
third drive fluid port 50c causes advancement of the third piston
117. The pistons 106, 116 and 117 and associated fluid paths may be
arranged so that fluid cannot enter the interior of the stapler
piston to advance the cutting piston 117 until compression piston
106 has traveled to the tissue-compression position and stapler
piston 116 has in turn traveled to the stapling position.
[0082] The anvil housing (identified by numeral 30 in FIG. 4) will
next be described with reference to FIG. 12. The anvil housing 30
includes mounting bores 88 for receiving pivot pins 36 at the
distal end of the hinged arm assemblies 32. The upper section of
the anvil housing 30 includes a section 94 through which the pivot
pin 44 for link 40 (FIG. 4) is mounted.
[0083] A central bore 90 extends longitudinally through the anvil
housing 30. An anvil support 92 is longitudinally slidable within
the bore. Both the bore 90 and the anvil support 92 are preferably
formed to have non-circular cross-sections (such as the illustrated
rectangular cross-section) with flat bearing surfaces to prevent
rotation of the piston within the bore.
[0084] FIG. 13 shows the anvil support 92 separated from the anvil
housing 30. The distal portion of the anvil support 92 is split
into upper and lower plates 95a, b. Plate 95a has a bore 93 axially
aligned with a similar bore in plate 95b. The proximal portion of
the anvil support 92 carries the anvil 96. As shown in FIG. 14,
anvil 96 includes a plurality of indentations 98 positioned such
when staples are driven from the staple cartridge, each staple leg
engages one of the indentations, which causes the staple leg to
fold. A central opening 97 extends through the anvil 96 and is
contiguous with a lumen in the anvil support 92.
[0085] The anvil 96 and the staple cartridge 78 (FIG. 7) are the
two parts of the stapler head which exert force on the tissue to be
stapled. As shown in FIGS. 9 and 14, the preferred anvil and
cartridge are designed to use a minimal amount of material
surrounding the indentations 98 of the anvil 96 and the staple
locations 80 of the cartridge 78--so that the amount of
anvil/cartridge surface area contacting the tissue is as small as
possible. When subjected to a constant force, a smaller footprint
will damage less tissue than would a larger footprint, since a
smaller area of tissue is squeezed between the anvil and cartridge.
However, the tissue that does get squeezed experiences more
pressure from the given force because the force is distributed over
a smaller area. In other words, the minimized footprint creates
more pressure on the tissue with less force. This is advantageous
from a mechanical standpoint because the stapler head need not
supply or withstand as much force as would be needed with a
larger-footprint cartridge and anvil.
[0086] Referring to FIG. 7, in the illustrated embodiments, the
staple cartridge 78 has an outer wall that tracks the contours of
the staples housed within it, thus forming a number of pedals 73
surrounding the outer staple positions or slots 80a, with the
grooves 79 disposed between the pedals, adjacent to the inner
staple positions 80b. Rather than providing each staple position to
be fully surrounded by cartridge material, the staple positions
80a, 80b preferably each include a back wall 71 a and a retaining
element attached to the wall and positioned to retain a staple
between the retaining element and the back wall. In FIG. 7, the
retaining element comprises a pair of wings 71b that curve inwardly
from the back wall 71 to define a slot that is sufficiently bounded
to retain a staple within the staple position, but that is
preferably not bounded around its full circumference. The anvil has
a similar pedal arrangement, as shown in FIG. 13.
[0087] Referring again to FIG. 13, a plate 99 is positioned on the
anvil 96 such that the distally-advancing cutting element 86 will
advance into contact with the plate 99 during tissue cutting. In
one embodiment, the plate 99 may be seated within the opening 97 in
the anvil. The plate 99, which will also be referred to as the
"cutting board", has a hole 101 in it which relieves the pressure
of the captured tissue and prevents hydraulic locking, a condition
in which the punch and plate create a closed volume. If it is
desired to move the cutting element 86 after contact is made,
pressure will increase inside this closed volume and it will resist
further motion. This may prevent or adversely affect tissue
cutting.
[0088] The cutting board is preferably designed so as to not serve
as a hard stop against advancement of the cutting element 86. If
the cutting element 86 is stopped by the cutting board, the
stapling piston will also be stopped and incomplete staple
formation may result. Therefore, it is preferred that the cutting
element 86 is allowed to penetrate or displace the cutting board
during and after the tissue is cut.
[0089] FIGS. 15A and 15B illustrate the cutting element 86 advanced
into contact with two different embodiments of cutting boards. In
the FIG. 15A embodiment, the material of cutting board 99a is a
relatively soft material, such as an elastomeric silicone, which is
cut by the advancing cutting element as shown. This material allows
the sharp distal end of the cutting element to move into the
cutting board during the final stage of staple formation. In the
FIG. 15B embodiment, the cutting board 99b can be made of a harder
material positioned with a compressible object such as an
elastomeric spring 99c behind it. In the figure, this spring is an
o-ring. Advancement of the cutting element 86 against the cutting
board 99b causes the cutting board to be displaced distally against
the spring 99c. The advancing cutting element 86 experiences
increasing resistance as the o-ring is compressed. Other spring
shapes and materials, such as coiled wire, spring washers and leaf
springs can be used to achieve the same result. The chamfer 99d on
the surface of the cutting board 99b may help to align the cutting
element 86 as it is forced into contact with the cutting board.
[0090] Arm Assemblies
[0091] Following is a discussion of the features of the arm
assemblies 32. FIG. 16 shows the arm assemblies 32 separated from
the other elements of the stapler head. In general, each arm
assembly has a first arm section pivotally coupled to the staple
housing and a second arm section pivotally coupled between the
first arm section and the anvil housing. While not present in the
illustrated embodiment, additional arm sections may be positioned
between the first and second arm sections.
[0092] Each arm assembly includes a proximal arm 100 and a distal
arm 102 joined to one another to form a hinge 104. Each of the
proximal arms 100 has a longitudinal cutout 108 and a spreader arm
110 pivotally mounted within the cutout 108. The distal end of each
spreader arm 110 includes a bore 112. Pin 84 is positioned within
the bore 112. As disclosed in connection with FIG. 10, this pin 84
extends through the disk 68 and has ends that ride within the slots
64 (FIG. 6) on the lower and upper sections of the stapler housing.
Longitudinal movement of the disk 68 within the stapler housing
will thus advance the pins 84 within their corresponding slots 64,
causing the spreader arms 110 to pivot relative to the pins 84 and
to thus drive the arm assemblies 32 outwardly. Additional specifics
concerning movement of the arm assemblies 32 is set forth in the
section entitled Stapler Head Operation.
[0093] Distal arms 102 of the arm assemblies include pins 36 which,
as discussed, are pivotally mounted to the anvil housing 30 (FIG.
4). A pair of drive links 114 are provided, each of which has a
first end pivotally attached to a corresponding one the distal arms
102 and a second end pivotally coupled to a common pin 116. In the
assembled stapler head, pin 116 is positioned in the bores 93 of
the upper and lower plates 95a, 95b of the anvil support (see
plates 95a, b in FIG. 12). As detailed in the Stapler Head
Operation section below, when the spreader arms 110 drove the arm
assemblies 32 outwardly, drive links 114 act on the pin 116 to push
the anvil support in a proximal direction, causing the anvil to
advance proximally towards the staple cartridge.
[0094] Stapler Head Operation
[0095] The following discussion centers on the manner in which the
arm assemblies function to expand the vacuum chamber and to
compress tissue that has been drawn into the chamber using suction.
As an initial step preceding chamber expansion, the stapler head is
positioned with the opening 26 in the membrane 24 in contact with
tissue at the location at which plication creation is desired.
Vacuum source 20 (FIG. 2) is activated to apply vacuum to the
inside of the vacuum chamber defined by the membrane. Tissue in
contact with the opening 26 (FIG. 3B) will be drawn into the vacuum
chamber between the staple housing 28 and the anvil housing 30.
After the tissue is drawn in, the stapler profile is changed,
expanding the volume of the chamber within the membrane.
[0096] The streamlined position of the stapler head 28 prior to
expansion is shown in FIGS. 4, 17 and 18. In particular, the hinged
arm assemblies 32 and membrane raisers 37 are in generally straight
orientations. The proximal arms 100 serve as the drive arms for
chamber expansion and tissue compression. Motion of these arms is
initiated when water under pressure is forced into the hydraulic
circuit of the staple housing. Referring to FIG. 19, the fluid
pressure advances disk 68 (by action of the compression piston 106,
not shown in FIG. 19). Disk 68 in turn pushes the staple cartridge
78 toward the anvil 96 as shown in FIGS. 19-21, causing the staple
cartridge 78 to extend further from the staple housing 28.
[0097] Both the disk 68 and the arm spreaders 110 are coupled to
the pins 84. For this reason, the longitudinal movement of the disk
68 within the stapler housing 28 will carry the pins 84 distally
within their corresponding slots 64. The arm spreaders 110 will
consequently pivot relative to the pins 84, driving the proximal
arms 100 outwardly. Outward movement of proximal arms 100 at hinge
104 causes the distal arms 102 to also pivot outwardly at hinge
104, forming an angle between the proximal and distal arms 100,
102. Naturally, formation of the angle between the arms 100, 102
shortens the effective length between the remote ends of the arms,
causing the distal pins 36 of the distal arms 102 to carry the
anvil housing 30 towards the staple cartridge. The pivoting
movement of the distal arms 102 further causes drive links 114 to
act on pin 116 to push the anvil support in a proximal direction.
This moves the anvil support relative to the anvil housing in a
proximal direction at the same time the anvil housing is also
moving proximally.
[0098] In essence, one motion, that of the hydraulically driven
compression piston, creates at least three motions, illustrated by
arrows A1, A2 and A3 in FIGS. 19-21. These three motions include:
the staple cartridge 78 moving relative to the staple housing in a
direction towards the anvil 96 (arrow A1), the anvil housing 30
moving toward the staple housing 28 (arrow A2) and the anvil 96
itself moving relative to the anvil housing 30 in a direction
towards the cartridge (arrow A3). This compound motion of the anvil
toward the staple cartridge enables a small displacement of the
compression piston to quickly compress tissue in the grip of
stapler. The multiplication of motion also enhances force
transmission between the two housings by keeping the angle at hinge
104, between the proximal (driven) arm and the distal (drive) arm,
as large as possible.
[0099] The relative motion of the two housings 28, 30 toward each
other also drives upward links 38, 40 and their interconnecting
spring wires 46 on the top of the stapler head 14. Together, the
links and spring wires raise the top of the membrane, creating more
volume to accommodate expansion of the tissue during
compression.
[0100] Compression of the tissue is halted when the pins 84
traveling in slots 64 in the staple housing 28 reach the limit of
travel, as shown in FIGS. 22-24. Thus, the slots and associated
components are dimensioned to set the desired separation distance
between the tissue contact surfaces on the stapler side and the
anvil side of the stapler head. Exemplary separation distances for
use in stomach wall plications might include approximately
0.06-0.07 inches (e.g. for use with staples having legs of 5.5 mm
length) or 0.109 inches for 6.5 mm leg length staples. Application
of additional pressure into the hydraulic circuit will not compress
the tissue any further.
[0101] Moreover, because of the piston arrangement, the stapling
function is effectively locked out until tissue compression is
complete. With this arrangement, fluid introduced via the fluid
port 50b (FIG. 11A) into the staple fluid channel 122 prior to
completion of tissue compression will leak until the two O-rings
112 of the compression piston 106 are straddling the inlet 114.
This design prevents premature staple firing.
[0102] At the fully compressed position, the arm spreaders 110 are
nearly perpendicular to the longitudinal centerline of the stapler
head. Once tissue is compressed between cartridge 78 and anvil 96,
the tissue is ready for stapling.
[0103] Stapling is initiated by introducing hydraulic fluid through
port 50b (FIG. 5). The staple piston advances, pushing cutting
element 86 (FIGS. 7 and 10) towards the anvil 96. Because the
staple pusher 76 is mounted to the cutter 86, this action carries
the staple pusher 76 through the cartridge 78 where it
simultaneously pushes all staples through the tissue. Staple piston
travel is limited by internal stops, and is preset to yield optimal
staple formation.
[0104] During compression, as the angle at the hinge 104 of arm
assemblies 32 reaches its minimum, the force required to resist
separation of the staple and anvil housings increases. These forces
increase further when the forces of staple crushing are exerted on
the anvil by the staple piston. To compensate, the arm spreaders
110 serve as displacement struts to channel at least a portion of
these forces into the disk 68. These forces, if not reacted by the
pusher disk, would pull in the arms 100, 102 and potentially
release the compression on the tissue, causing incomplete staple
formation or tissue cutting. In this way, a truss-like structure is
created for force displacement.
[0105] When staples have been formed, staple pressure is released
and a spring (not shown) returns the staple pusher 72 to its base
position. Releasing fluid pressure will allow the deflected spring
wires 46 on membrane raiser 37 to return the staple head to its
minimum profile configuration and release the plication from the
stapler. Once outside the patient, the used staple cartridge can be
ejected and a new one installed.
[0106] FIGS. 25A-25C illustrate one method for retaining a
removable staple cartridge 78 within the staple housing. The
cartridge is spring-loaded into the staple housing and retained by
two latches 170 (one visible), each pivotable relative to a fulcrum
172. As shown, the fulcrum 172 may be coupled to the disk 68 by pin
84. Each latch 170 includes a catch 174 which engages a
corresponding catch 176 on the cartridge. The latch 170 is
preferably spring biased to urge the catch 174 inwardly towards the
cartridge.
[0107] Depressing the proximal end 175 of each latch 170 as shown
by arrow P in FIG. 25B pivots the latch against this bias, causing
ejection of the staple cartridge. A new staple cartridge may then
be positioned with its grooves 79 aligned with alignment posts 74
as shown in FIG. 25C and then pushed towards the staple housing. As
the new cartridge slides into position, catch 174 rides over the
tapered proximal portion 178 of the catch 176. Once catch 174
passes over the distal end 180 of the catch 176, it drops inwardly
towards the cartridge due to its spring bias, thus engaging the
cartridge. When the cartridge is properly seated, a click will be
felt or heard as the latches engage the new cartridge.
[0108] Stapler Shaft and Handle
[0109] Referring again to FIG. 2, the stapler shaft 16 connecting
the handle 18 and the stapler head 14 is flexible enough to conform
to the curvature of the upper digestive tract, yet maintains the
ability to transmit enough torque to rotate the stapler head. The
shaft is formed with sufficient stiffness to allow it to be pushed
down esophageal guide tube 23. Suitable materials include
[0110] FIG. 26 shows a distal portion of the shaft 16, with the
stapler head removed from the shaft. As shown, shaft 16 includes an
endoscope lumen 124 through which an endoscope is advanced to allow
visualization of a stapling operation. Side lumens 126 may also be
provided for receiving other instruments useful during the
procedure.
[0111] An articulating section 128 is positioned at the distal end
of the shaft 16, between the shaft 16 and the stapler head 14 so as
to allow the stapler head to be articulated relative to the shaft.
Tubing coupled to the vacuum source and the source of hydraulic
fluid extends from the handle and through the shaft 16 and the
articulating section 128.
[0112] FIG. 27A shows one configuration that may be used for the
hydraulic fluid lines 130. During use, the hydraulic fluid lines
are subjected to significant deflection and elongation in the
articulating section of the stapler. They are also subjected at
times to fluid pressure which may be in excess of 1000 psi.
Typically, hydraulic lines in industrial applications are flexible
and have a working loop of extra tubing that accommodates length
changes during use. The illustrated configuration for the hydraulic
lines is a lower profile solution particularly suitable for an
endoscopic device having space constraints. A preferred hydraulic
line is a tube 130 having a portion that is shaped into a
longitudinally expandable shape so that it can accommodate
effective length changes during bending. The longitudinally
expandable portion of the tube is preferably disposed within the
articulating section 128 of the stapler 12. In a preferred design,
the longitudinally expandable shape is a coil shape as shown in
FIG. 27A. In alternate embodiments, the tube 130 may be formed into
other longitudinally expandable shapes, such as regular or
irregular undulating shapes (FIG. 27B).
[0113] The preferred material for the tubes 130 is stainless steel
hypotube, although other materials may instead be used. In the
preferred stapler configuration, two drive fluid lines are
provided, one for actuating tissue compression, and the other for
staple application (and cutting when used). In the present
embodiment, the tubes are coiled together as shown in FIG. 27A. In
alternate embodiments, two or more coiled tubes may be nested one
inside the other. As the articulating section bends, it forces the
coiled tubes 130 to bend and to change length in response to
bending. The coiled tubes behave just as coiled wires would during
these motions and are thus able to change length, deflect, and
follow the contour of the articulating section without compromising
flow through the lumens of the tubes or imparting undue stress to
the connections at either end of the hydraulic system.
[0114] The longitudinally expandable shapes for the fluid lines may
be suitable for use in allowing delivery of fluid to the operative
ends of other types of articulating medical devices, such as
catheters or endoscopic devices for delivering therapeutic agents
or irrigation fluids past an articulating or bendable section of
the device.
[0115] Referring again to FIG. 26, articulating section 128 is
comprised of a spine formed of a plurality of links 132 strung over
a pair of pull cables 134 (only one shown in FIG. 26). In one
embodiment, engagement of the pull cables allows the stapler head
14 to be articulated in two directions through a range of motion of
approximately 90 degrees in one direction (see FIG. 3B) to 175
degrees in the opposite direction (see FIG. 3C). Each pull cable is
anchored at or near the stapler head, such as at the distalmost
link 132 of the stapler housing 28.
[0116] The more proximal portions of the pull cables 134 extend the
length of the shaft 16 and terminate in the handle 18. Referring to
FIG. 28, the handle 18 includes a rotating knob 136 that may be
selectively rotated in a clockwise or counterclockwise to
articulate the stapler head up or down. Rotation in one direction
applies tension to one of the pull cables to cause the stapler head
to bend downwardly, whereas rotation in the opposite direction puts
tension on the other cable, causing the head to bend upwardly.
[0117] In a preferred handle configuration, the knob 136 includes
an internal threaded bore 138. Knob 136 is partially restrained
within the handle 18 so that it remains fixed within the handle but
can rotate freely. A carriage 140 having a threaded exterior
surface is positioned within the threaded bore 128 of the knob. The
threads within the bore 138 are engaged with the threads on the
carriage 140 so that rotation of the knob causes the carriage 140
to translate, but not rotate, within the handle.
[0118] Each of the two pull cables, identified in FIG. 28 as cables
134a and 134b, is terminated on a different member in the handle.
Cable 134a is mounted on the sliding carriage and cable 134b is
mounted to a stationary part of the handle 18. Each cable extends
through a corresponding sheath. Cable 134a extends through a sheath
135a having a proximal end fixed to a stationary part of the handle
18. Cable 134b extends through a sheath 135b having a proximal end
mounted to the sliding carriage.
[0119] The cables 134a,b and sheaths 135a,b are arranged such that
translation of the carriage in one direction will cause deflection
of the stapler head in one direction, and translation of the
carriage on the other direction will deflect the stapler head in
another direction.
[0120] Referring to FIG. 28, if knob 136 is rotated to causes the
carriage 140 to translate to the left of the page, cable 134a will
be tensioned and cable 134b will slacken, causing the stapler head
to articulate in a first direction (e.g. upwardly). Rotation of the
knob 136 in the opposite direction will advance the carriage to the
right of the page, releasing tension on cable 134a and pushing
sheath 135b over the cable 134b towards the distal end of the
staple head, causing articulation in the second direction (e.g.
downwardly) as the sheath 135b is advanced against a distal portion
of the shaft 16. The proximal portion of sheath 135b is provided
with sufficient working length prevent it from being placed under
tension when the carriage moves distally. The positioning of the
knob is advantageous in that the hand movement required for stapler
articulation is always the same, regardless of the rotational
orientation of the stapler. Also, the use of the threaded knob can
prevent unintentional relaxation of the deflection angle, even if
the knob is provided without a lock to retain its rotational
position.
[0121] Referring to FIGS. 28 and 29, the endoscope lumen 124
extends along the center axis of the stapler. The positioning of
the lumen and the coaxial relationship of the articulation knob in
relative to the endoscope 124 allows the endoscope and stapler to
be rotated independently without one interfering with one another.
Thus, if the user chooses to change the rotational orientation of
the stapler head 14 within the body, s/he may rotate the handle 18
and shaft 16 while maintaining the rotational position of the
endoscope.
[0122] For cost efficiency, the stapler 12 may be designed to
permit the stapler head 14 to be discarded while allowing the shaft
16 and handle 18 to be sterilized and re-used. One mechanism for
removably coupling the stapler head to the shaft 16 is illustrated,
although others are readily conceivable (e.g. a slip coupling type
arrangement). Referring to FIG. 26, an end plate 142 is mounted to
the distalmost one of the links 132. Each of the end plate 142 and
the corresponding rear surface of the stapler head are provided
with latch features that allow the end plate and stapler head to be
engaged to one another.
[0123] End plate 142 includes a cantilevered pin 144 having a peg
145 (which may be a spring pin), a central opening 146, and a pair
of u-shaped catches 148 along its edges. Hydraulic feed holes 156a,
b are formed through the end plate 142. The hydraulic tubes that
deliver hydraulic fluid to the stapler head (see tubes 130 of FIG.
27) are preferably welded to the end plate to allow fluid from the
tubes to be directed through the feed holes 156a, b.
[0124] FIGS. 30A and 30B show the rear surface 48a of the staple
housing, which has been somewhat modified relative to FIG. 5. In
this variation of the rear surface 48a, the hydraulic input ports
50a, 50b are repositioned as shown. Additionally, the rear surface
48a has been modified to include a pair of catches in the form of
undercut bosses 150, plus an aligning pin 152, and a hole 154.
[0125] FIGS. 30A and 30B show the end plate 142 positioned against
the rear surface 48a of the staple housing. The other features of
the articulating section 128 are not shown in FIGS. 30A and 30B for
clarity. To attach the stapler head to the shaft 16, the plate 142,
attached to the handle assembly, is pressed against the rear
surface 48a of the staple housing as shown in FIG. 30A. As the
plate is pushed, it is rotated in a clockwise direction, causing
the peg 145 (FIG. 26) of the cantilevered pin 144 to engage hole
154 in the rear surface of the staple housing. When this latch is
engaged, hydraulic feed holes 156a, b of the end plate 142 are
lined up with the hydraulic inlets 50a, 50b on the staple head as
shown in FIG. 30B. At the same time, portions of the end plate
surrounding u-shaped catches 148 slide beneath the undercut bosses
152. Pressing the plate compresses the face-sealing O-rings
surrounding the hydraulic input ports 50a, 50b. Compression on the
O-rings is maintained by engagement of the catches and the undercut
bosses overhanging the end plate. To remove the stapler head from
the housing, the stapler housing is twisted in a counterclockwise
direction to disengage the end plate 142 from the rear surface 48a.
The stapler shaft and handle may then be sterilized in preparation
for mounting of a fresh stapler head.
[0126] Exemplary Procedure
[0127] One example of a method for using the system 10 will next be
described in the context of formation of plications in stomach wall
tissue.
[0128] As an initial step (FIG. 2), endoscopic guide tube 23 is
advanced into the stomach via the mouth and esophagus. The
endoscope 22 is inserted into the endoscope channel in the stapler
handle (not shown) and advanced down the lumen of the stapler
handle. The stapler/endoscope are simultaneously passed through the
endoscopic guide tube towards the stomach. Once the stapler and
endoscope reach the gastroesophageal junction region of the
stomach, the position of the stapler is maintained while the
endoscope is advance further into the stomach.
[0129] The stapler head 14 is advanced to the desired depth and
location in the stomach. Using the articulation controls on the
stapler handle, the angular orientation of the stapler head is
adjusted to allow positioning of the stapler head 12 at the
pre-identified target tissue as shown in FIG. 31A. The opening 26
in the membrane 24 is positioned against the target tissue. The
endoscope 22 is placed in a retroflexed position as shown.
[0130] The vacuum source 20 (FIG. 2) is coupled to the vacuum port
on the handle external to the body, and vacuum pressure is applied
to draw tissue through the opening 26 and into the vacuum chamber
defined by membrane 24 as shown in FIGS. 31B and 32A. Acquisition
of the target tissue will be readily identified endscopically
through the wall of transparent membrane 24 on the stapler
head.
[0131] The fluid source (is shown) is coupled to the handle. Once
it has been visually confirmed that a sufficient amount of tissue
has been acquired, fluid is introduced to cause compression of the
tissue and expansion of the arm assemblies 32 and membrane raiser
37 as shown in FIGS. 32B and 31C. As can been seen, the expansion
of the arm assemblies and the membrane allows a large volume of
tissue to be acquired into the vacuum chamber and displaced further
into the chamber during tissue compression.
[0132] Once the tissue has been compressed, additional hydraulic
fluid is introduced to cause stapling and cutting of the tissue as
shown in FIGS. 31D and 32C, forming a plication P. The compression
and stapling hydraulic sources are then deactivated to release
fluid pressure within the hydraulic circuit. With the hydraulic
pressure relieved, the spring wires of the membrane raiser 37 help
to restore the stapler head 14 to its original streamlined
configuration, allowing the stapler head to be withdrawn from the
tissue as shown in FIG. 31E. The stapler head may be articulated
relative to the shaft to assist in moving the stapler head away
from the plication P.
[0133] In a preferred plication configuration shown in FIG. 33 the
staples 158 are arranged in two concentric rings of five staples,
with the staple reinforcement device 83 retained by the staples and
distributing forces around the staple pattern as shown. The
plication P includes a hole H formed by the cutting element,
through which various implants or anchors for various implants can
be placed.
[0134] If multiple plications are needed, the stapler 12 is briefly
withdrawn from the endoscopic guide tube and the staple cartridge
is replaced in the manner described in connection with FIGS.
25A-25C. The procedure is repeated until all desired plications
have been formed.
[0135] The system may be packaged with instructions for use
instructing the user to use the various disclosed features to
perform a stapling procedure using methods disclosed herein.
Alternate Embodiments
[0136] The basic architecture of the stapler disclosed above can be
used as a foundation for other stapling tools. FIGS. 34-35 show a
modified stapler in which the membrane and membrane raiser have
been removed, and in which the staple housing 28 has been modified
for the attachment of tools. As shown in FIG. 34, the staple
housing 28 includes a pair of grooves 160 proportioned to receive
tools 162. Tools 162 may be seated in these grooves 160 and mounted
to the staple housing as shown in FIG. 35. This attachment will
provide for a stable base from which to actuate the tools. The
tools may be self-articulating, or the staple housing 28 may be
equipped with devices 164 for moving the tools between streamlined
positions for insertion of the assembly into a body cavity, and a
deployed position such as that shown in FIG. 35. Tools similar to
those in FIG. 35 might be used for tissue acquisition, by reaching
between the cartridge and anvil and used to engage tissue and pull
the tissue into position between the cartridge and anvil so that it
may be stapled, or otherwise affected by various features added to
or in place of the anvil and cartridge. Procedures which may
benefit from adaptation of the stapler include, but are not limited
to gastroplasty, stoma adjustment, polyectomy, lead placement,
bleeding control, perforation or hole closure, biopsy and tumor
removal.
[0137] The disclosed systems provide convenient embodiments for
carrying out the disclosed compression and stapling functions.
However, there are many other widely varying instruments or systems
may alternatively be used within the scope of the present
invention. Moreover, features of the disclosed embodiments may be
combined with one another and with other features in varying ways
to produce additional embodiments. Thus, the embodiments described
herein should be treated as representative examples of systems
useful for forming endoscopic tissue plications, and should not be
used to limit the scope of the claimed invention.
[0138] Any and all patents, patent applications and printed
publications referred to above, including those relied upon for
purposes of priority, are incorporated herein by reference.
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