(12) STANDARD PATENT (11) Application No. AU 2010200618 B2 (19) AAUSTRALIAN PATENT OFFICE

(54) Title Circular Stapler Buttress Combination

(51) International Patent Classification(s) A61B 17/00 (2006.01) A61B 17/072 (2006.01) A61B 17/115 (2006.01) A61B 17/11 (2006.01)

(21) Application No: 2010200618 (22) Date of Filing: 2010.02.19

(43) Publication Date: 2010.03.11 (43) Publication Journal Date: 2010.03.11 (44) Accepted Journal Date: 2012.06.21

(62) Divisional of: 2003220427

(71) Applicant(s) Synovis Life Technologies, Inc.

(72) Inventor(s) Mooradian, Daniel L.;Oray, Nicholas B.;Kluester, William F.

(74) Agent / Attorney Wrays, Ground Floor 56 Ord Street, West Perth, WA, 6005

(56) Related Art US 6099551 US 5503638 2010200618 19 Feb 2010 10 5

upon use. one the the buttress stapler preparation material upon primarily

buttress invention

or

Positioned the activation

more is A

material

secures

staple

actuated combination to

material of form portions

allows the

cartridge of buttress

and is

the buttress to

the made

to tissue connect seals of improved

circular

medical the

preformed

material(s)

and/or up

the material portions stapler

of

previously

newly

stapler

two device

seal. anvil

prior

buttress

are regions, to are

ABSTRACT connected

The components

to be comprising

also to delivered

form severed

joined

39 former actuation,

material described. one

anastomoses,

tissue.

without of tissue

region to

a of

which

circular a adapted and the

tissue

portions. Methods

is the stapler one

serves

severed

while

use site stapler

to of

be

which

prior of where of primarily An

the stably

sutures. and use instrument

embodiment

or remaining

serves the and discarded

at positioned

to the circular The

secure

time and

of

of

11/14 2010

Feb

19

2010200618 P/00/011 28/5/91 Regulation 3.2

AUSTRALIA 2010 Patents Act 1990 Feb

19

ORIGINAL

COMPLETE SPECIFICATION

2010200618 STANDARD PATENT

Name of Applicant: Synovis Life Technologies, Inc.

Actual Inventors Daniel L. Mooradian Nicholas B. Oray William F. Kluester

Address for service is: WRAYS Ground Floor, 56 Ord Street West Perth WA 6005

Attorney code: WR

Invention Title: Circular Stapler Buttress Combination

The following statement is a full description of this invention, including the best method of performing it known to me:-

1/1 2010200618 23 May 2012 25 20 30 15 10 5

anastomoses. gastrointestinal recently, pages and polymeric staplers. and, of and example, cartridge, of and include These circular procedures Conn.,

staples. staples

use hemostatic circular by

3-7 instruments

and

In Circular Surgical Surgical

the

firing of stapler,

circular

In

linear

against one from in

materials. In preformed

the use for

another staplers, Atlas

use,

(See the aspect,

many ILS™ CIRCULAR

of a wound

surgery staplers, manufactured staplers stapling staplers

staple staplers which

instrument,

the

buttress of pages are

aspect,

years. which Surgical In surgeon heterologous the

circular typically BACKGROUND closures.

holding

to

yet the are have

which instruments

19-21, invention have

facilitate and

the

typically another known staples Commercially STAPLER

cause

been

will stapler, Stapling, by

reinforcing

been

invention typically indicated cartridge, TECHNICAL Atlas

See, United

place

tissues used relates are and

the inverted aspect, developed,

typically

apply

for manufactured of

formed.

staples

have Feil/Lippert/Lozac BUTTRESS

for tissue OF

apply Surgical States

relates instance, for

and materials for to

1

available

the one

over

THE

end-to-end, been use surgical

implantation

an

have

to between FIELD one

invention Surgical or

having Such

to

a in anvil

become

Stapling

INVENTION

successfully more

century “

surgical or gastric a History

formed by

instruments COMBINATION

mechanism staplers, instruments more

disposed

particular

Ethicon,

the

concentric Corporation, end-to-side

relates clenched

cited ’

for and

h/Palazzini within staple stapling parallel of of

providing

including Mechanical stabilized esophageal used

above). opposite to

Inc.,

include use

for

cartridge include,

the

the

and to

rows procedures

in and

firing

in Blue Norwalk, the

body.

preparation

surgical (eds.).

circular

circular

leak-proof side-to-side

tissues the of the tissue.

for surgery Ash, Stapling a and

staples,

CEEA™ plurality staple

More

that anvil rows and Ohio.

”

,

2010200618 23 May 2012 20 25 30 10 15 5

wherein then place one remaining anastomoses procedures, anastomosis tissue anvil connected intestinal conventional “ postoperative resection other patients An line, firing, formed continues 5,503,638; buttress,

early end

fired after

is complications. adjacent

inside the

In While On

against drawn of and tubular

” survey

” tract

one which to to instrument

to ends Dis. intestine a “

5,549,628;

when

pledget

included cause be (joining) the different conducted, the

surgical

leakage, circular common

into a is

Colon the

a are

organs

of staple staple the

instrument. removed

significant used

the anvil. close stapler-related

rejoined ”

is

surgeon

or

L.E. is

anastomotic staplers. has subject,

Rectum

secured staplers staples 5,575,803;

which cartridge.

line,

alone are

procedure, typically

“

intraoperative approximation reinforcing During

been (i.e., Smith, joined

thereby

by

problem.

Once

will

they can

to

a 24, about have

using achieved. due

See

variety

pass

the

removed

carefully

Preferably, be “

to 5,752,965;

complications

236 are leak, the known Anastomosis

to generally,

been establishing

” other quite firing

an

through a

prone materials the anvil

(1981).

complications circular

of anvil tear to

extremely

presence

as anatomical dangerous

2 references by the step, inspect

shaft

to during

end-to-end

the 5,782,914 and

withdrawing tissue

Applicant stapling

creating

More stapler.

for

a

with a revealed

anvil

is the

circular

passage

the

of use

stapler secured helpful of

in recent other teach EEA

were

structures. disease

surgical

has

both cartridge.

To in a

gastrointestinal and ’ anastomosis,

s

number

that

combination

knife

join

a own between extraction,

stapler the end

the

reported

in organs to studies 6,312,474. shaft

such

in a the

anvil

preparation site the of

US is number

the

The

of

that intestine after advanced instrument,

tubular

to as and Pat. have the

in complications. through 3594

instrument ensure cancer) a bleeding,

is

with

15.1% organs. colonic become tissue, portion Nos.

of removably indicated

end-to-end

structures, of surgical is

to the a

held

and

of

the

proper

cut

After of

and

staple is

the

the in that

2010200618 23 May 2012 25 20 30 10 15 5

of preparation conventional the conjunction 6,273,897, stapler, positioning for and comprising: reference. Application stapler immediately delivered at positioned strength lines, tissue first

the the

use

anvil.

corresponding region

and time components sections

... with By On (b) In What (a) nor

and

”

to one particularly

may

comparison,

a upon of, which

the of and

and

No. with circular a

separate buttress before buttress is

tissue aspect,

buttress use,

one a upon

be

demands

clearly

using

use

the circular WO

other

discloses

suitably

and b) anvil or

the

of staple

site activation staplers.

seal.

99/48540,

subject, materials while the more such

circular

“ material

positioned

types needed claims relatively preformed

in component,

of stapler SUMMARY present

modified

cartridge

combination materials,

a portions its in

of

surgical

Applicants

Presumably,

position staplers, use,

that are of

(e.g., as

surgical the instrument,

invention

few the

material ” a

materials

are “

disclosure tissue staple the and/or to of

and pledgets). stapler,

particularly buttress

references

OF

conducive provide buttress upon

having

present staplers with

have

THE implants.

3 line

portion(s) this anvil

provides

comprising and

the and the

for

of also

buttress improved

buttresses is material INVENTION

invention

For

and methods stapler

components

suggest stapler which optionally to use since due

previously

the instance,

a cutters. See

to

with

to combination

seal

neither

component(s),

the placement is a

components, adapted the

published properties

the

on for staple may

incorporated linear

tissue

retained

problems and

the use

providing For of U.S.

described be the

cartridge the

staple preferably, to

of staplers,

example, similarly site,

shape

Patent or

be International buttress medical such

stapler between

use

c)

inherent a) to to

cartridge herein surgical

upon

the as

stably

of

provide then of No. component mentions

a

prior utilized

staple

a materials device d)

circular

joined

circular

delivery

be

by to in

staple

and

to,

a line

in

or

2010200618 23 May 2012 25 20 30 15 10 5

time, tendency third component permit as component the packaged dehydrated) and as material can region material material delaminated retains structure, component upon prepared of

gels a separate

components.

be the method

region, activation if

portions provided the

sufficient or In In The Optionally, desired. resultant

that of over

in to optionally other ties. separately

a removal

portions suitable into in can

particularly a buttress

prompt

of form, from e.g.,

extends

manner the a

making

that be aspects,

manner of the

in

combination. properties, component.

Also axial

its

or

a accomplished

a

buttress

of

dimensions body the

would

of material stapler aided

from form

position at beyond that

one

optionally,

buttress

and and

formation any preferred sufficient the

and

permits the that or with

extend

external a knife material

suitable invention

including

is more

method the to in stapler

While permits

adapted material, The

ancillary to a

the

rim

or

provided

embodiment, surgical to of the positioning beyond prepare portions

facilitated

buttress to course

stage

can

permit

adhesions of components, it

of tissue

provides

shear the them

is

to a

using

include wherein

materials

stapler generally

of the

be second anastomotic 4 a

by

of

of the to combination material to resistance,

hydration.

positioned

tissue positioning.

the both of

by a

retain be a within material the

second

the component, the

kit

each the

stapler. either region,

or

described combination the not

comprising sections use

material a can use in

the

portion three buttress

preferable site. to

region a of removed to The upon

of be as

manner for tissue avoid

be one

ancillary described provided

dimensional

By

material being herein, instance and upon

delivered

a

comprises

of

or materials

respective preformed virtue being comprises site),

is the or pre-positioned more to

joined

a

used

biodegraded

the include respective

buttress

materials, can in

in such above, dislodged of

portions with

material dry

the

to

themselves its

animal structure also

(given

stapler

a regions buttress

slip

form physical (e.g., third plurality the

as material

be

fit such

well

of

tissue upon or

their

over of

the

a

2010200618 23 May 2012 25 20 30 15 10 5

(e.g., preformed combination parts with retain desired region be component. adapted as hydration. a corresponding (e.g., components, permit corresponding second including Preferred fashion lumen

predetermined

the removed

the throughout

raised/indented sewn)

the

staple

for is the

FIG. The In region

three upon

to

severed

generally

preformed materials a

the

the placement assist tissue

first

buttress

to from

1 line Preferably, with

preferably

dimensional a

joined Drawings,

is is

retain to grooves, respective

region

desired internal perspective ends in the buttress portions a

the the

respective concentric BRIEF positioning

in

material

same:

tissue materials

suitable

tissue

portions,

and buttress of place

adapted

apertures, without

the shape wherein the to

itself, retention stapler can and/or

portions. DESCRIPTION

the site

upon one joined

view portions

three

stapler to, be material

have

in ridges)

circular and/or

to upon the together

or

treated

topographic component, and the like

the

of remain ridges

dimensional more

tissue of a need

a course component.

respective activation integral “

reference preferably the

retaining that circular memory of seam

(e.g.,

portions

and with

for the portions portions in

5 permit

OF of

position

adhesives,

edges present formed,

e.g.,

structure with, chemically one

use, stapler,

”

numerals the structure THE of

stapler

provide that

of

them The

by or upon in the

the buttress including of

the

order within permits more invention; DRAWINGS press

and

stapler the

preformed

exploded

adapted

first

component.

to ties, second respective

two

and

are treated) can stapler be

to portions

fit

region,

material the

and

positioned utilized them

or topographic

provide in knife. be or

to

region body

more various

at

the friction removed device

tissue position and/or

to stapler

the

of

providing Generally, like. The

upon

to in retain an regions,

a are distal

designate portions order

stages

second in

component.

unobstructed fit manipulated second

features The

together adapted a a and/or

onto or

stapler secure end,

to

a assume

of

the region

serve the

in like

to

2010200618 23 May 2012 25 20 30 10 15 5

two preparing type anastomoses; tubular anvil device second two by buttress preferably (16) components, elongated various assembly fastener circular respectively. component

focusing

(10). major

is of in

placed of

FIG. FIG. regions FIG. FIG. Referring FIG. homogenous tissue Referring

components combination surgical head (20),

the at a

arm The components; includes

portion (14).

the on 4 6 3 2 5

the present

which

(6), sections

between is is is is is

proximal (10)

are the

surgical

a a a an stapler a

staple

to to Also

a

schematic view schematic block

shown distal

at proximal of two exploded

FIG.

FIG.

are

of buttress with invention,

the homogenous

using

the shown the cartridge

in (4), components; the secured

handle site

diagram

fastener 2, 1,

distal

the after

perspective staple distal

there

staple the the

DETAILED the and

view view

material handle

view buttress is

being

combination end section buttress including

buttress

to

buttress

component bears

fastener cartridge is illustrating

head

cartridge

in illustrating the

in

buttress shown

of

section

perspective

the severed perspective

according material

of the staple the

(6). allows

including

material

material buttress staple

DESCRIPTION head.

a

instrument, controls 6 component a

circular component As

material.

(8)

(12) preferred device a

cartridge

by

the

for process

just

of

cartridge and

The

to

a

illustrating

and of

of technique material

the (16)

positioning a

circular

the which

described,

of surgical an staple the a distal

present

the

circular

is

(12) embodiment adapted and FIG. invention; for

elongated

(12) present

composed

buttress anvil

trigger

the in cartridge fastener anvil knife

and

for 1 and

the stapler

which invention;

is of manufacture

the stapler

(14). for

the stapling

invention

shown technique

components, a blade; the

the

arm and (18)

fastener corresponding

use

anvil head, of of

the (4) buttress

staple activation

Buttress

cartridge

connecting

two a and with

in having

first combination abutted

(14)

mounted

to more

major head the for

head of

the

and form (18)

and one material

anvil

a

and

of

detail has

distal

anvil

the

an

the

on

2010200618 23 May 2012 25 20 30 15 10 5

(12), the that preferred movable plane circumferential aperture aperture the plurality position circumferential combination to adapted cartridge shaft buttress adapted face includes the section

the

positioned cartridge

staple

is

(34)

and (44).

defined anvil dimensioned

As In The Connecting

of

to to (20)

a

and (24),

a

of between component to having embodiment,

cartridge

a terminal the generally be be shown,

The staples buttress preferred staple ultimately

adapted for component adapted

positioned positioned

by second and tissue

ring seam anvil

joining

an the

a cartridge a

the

(38)

section

the component

first, outer and recessed disc-like

of

cylindrical

staple upon to to to between tissue shaft embodiment,

stapler

be

tissue staple

the

allow be positioned be

adapted first (12), upon upon

extended edge positioned

actuation delivered of positioned extends anvil

forming buttress portion

and

annular

portion

also and the cartridge

for as

the them. the

(36),

(12),

staple

to

shaft

well

second easy first

buttress

open staple includes

position within

be proximally

the

in

surface

(18) the of

and between from

(32))

scalpel As

as tissue upon positioned can cartridge apposition placement

the invention component

face

face

a cartridge abutting shown adapted is

the

material. circumferential be the

Ί

stapler, in

an

shown and

the

of

portion. (34)

and blade

readily

order face the cartridge anvil

anvil.

and

anvil a component in

edge provides into of to of to second, abutted sections

component

and having FIG. as to (40) substantially

to

component

retain the the

the

detached component

well The The the a

serve

being adapted

recessed in positioned positioned staple 2, buttress

anvil

tissue

retracted

a anvil stapler order flat, and the of as a

(12) raised as

surgical

adapted tissue a

(12) distal

cartridge

from

position a disc-like generally

component to

(14), shaft

sections to

component(s). staple comprising perpendicular aperture

(14).

also

be

central

sever and first within position.

in the

fastener

delivered stapler mateable to is

order includes

line

an

a tissue longitudinally staple retain component

portion

an (and

central

terminal

(24) region the anvil

is

buttress.

internal

to

a head

the

In

central adjacent in

and circular within

form with through

from a

the

(26) the anvil (22)

(6)

a

a

2010200618 23 May 2012 20 25 30 15 10 5

the conical delivered circular (42) rounded, course discontinuous order circular planar of buttress secured material circumferential into fully portions. embodiment, application reinforcing material(s) delivery including

a

anvil

corresponding position

forms

traverse, to

circumferential of

The With

portion

to face face, materials

form

upon of

component conical

a through

buttress

the

the

following the surgical as region buttress

bears respect

around and

the

a

the the corresponding and (e.g., bottom

annular and seal regions

shape

system

in

face are

first the materials thereby (48) an

stapler

the stapling therebetween. as

materials turn, to an as

actuation dimensioned tissue array

of

exterior

and and in

the to scalpel. circular and shown anvil (22

includes the

the to

allow

component. sever,

second stapler to of

the

and portions be adapted

procedure.

conical

form stem circular

thereafter

also staple-forming

includes

region positioned

discardedregion

of face, 28) FIG. it

tissue

a

to shown the

a regions already provide

and The plurality

adapted

split

to shape pass

upon adapted

3 face stapler (26

be

shows adapted The retained an be buttress A

washer

in

through

and

positioned between of

8 of actuation positioned annular typical severed and a

these buttress

to

of preformed,

the a (including

to

grooves the

32)

buttress, stably

is

preformed

to

(50). permit materials between

staple

that

adapted

Figures, two tissue

anvil adapted be

recessed from the

materials of

on would positioned

and within These (46) basic

abutting the

cartridge the

component

respectively. scalpel). nonplanar the more

the

the

releaseably to

can

corresponding buttress to circular annular adapted

aperture

regions

anvil permit

buttress

be are a cartridge generally

be comprise readily. stapler

positioned

sections

also over

component.

continuous and These

materials,

interior scalpel stapler.

to them (14) of

device (30)

referred

the

position component.

clinch cartridge In

and

the A cover

a

has

of include a

to circular preformed circular between

generally

buttress preferred and anvil. (40)

tissue

be

Finally, upon

a

staples or

the

to

The

the slid

to

in a

face in face

the this

2010200618 23 May 2012 20 25 30 15 10 5

6,102,271, procedure described tissue reinforced various head instruments for for tissue positioned typically as anvil using position shaft component "distal" "proximal" Such between which

the

applying preparing

(6)

(44). component instruments

a

(52) has interior the

The In FIG. preferred controls refers

spaced connected them.

sutured

another herein,

been

two using

stapled over are

the

The refers (12) combination

are 4 a

such

to surface

circular shows positioned disclosures components

properly

This found, and staple away and and such

the

to respectively.

embodiment as typically to

aspect, connection a

by

hold

well

within the end buttress the

levers is

a a

from

of cartridge

an array

for cross-section shown

material

end

anvil

positioned, furthest the

of it as the elongated over

instance, of

in include their

the for are this

a

of of tubular

material,

which

invention

place buttress

component for in

of

the

the the adjacent staple The fasteners,

invention buttress and

respective the

from this tubular

ends operation apparatus

a

over

cross

in

are arm

tissue the combination. second view proximal

invention. cartridge

material, and US the

provides

incorporated of

anvil with (18) the (10).

tissue e.g.,

section

(14)

can

operator. Pat. the of 9

a (54) stapler

step stapler

method

of

closest the

and tissue

component

include staple staples.

Throughout handle are Nos.

component the are per

in

a

overall of In of the

connected four kit

components.

shown. instrument.

se, components. the and the

the 5,411,508,

The to of cartridge herein

anvil

for section

any

adapted

the Examples

steps, performing procedure. first tubular buttress

process

handle preparing is

suitable operator, buttress to this

The moved by step,

by from

the (8) component

reference. for

description, tissue

5,558,579,

tubular

means materials section

of

Once

and closed two of The

such

top surgical a (20) creating from a

suitable while

surgical

combination

a ends wall

stapler the

to distal

of

tissue use, can (8) position,

the

bottom,

the and sandwiched tubular See the and

(56)

of

instrument

includes the

a be open

a

fastener

cartridge

stapling tubular

anvil

the term method is

FIG.

seen term as

in

well as

1

.

2010200618 23 May 2012 20 25 30 15 10 5

(e.g., aperture anvil of 20), art, the 4,576,167, and the or at been aperture sandwiched out (40) fastener embodiments as utilized fastener be stapler alternative

least the polycarbonate following

well

buttress anvil

in causing

described and

is

successfully component. colon)

firing a

extended

with In

A one It

within recessed

in firing head,

(24) into (24)

assembly

will buttress the

the

materials 5,005,749,

piece

material, staples tissue/buttress

a stroke, portions

assembly contact

of are third

pivoting disclosed be

components in as levers the

the

through

several annular understood shown shown

for

of

completed, material

Simultaneously, invention

step, and

(38) staples staple

buttress

will housing with present the together

and

of fastener

components

herein. to in in firing

patents,

the overall ring

readily the

the

cartridge

5,119,983. the be FIG. of of material. (38)

sandwiched disclosed material

that on

anvil

sections the this a corresponding ejected

within remain, of last

clean head

are 2. the For

operation

such come the various

surgical

invention

step and

The or

fully

proximal component which

example,

the instrument instead The

cut through

holding

thereafter,

and as

forming

Except in to

staple of severed

anvil, commonly

formed tissue line the

modifications the annular

FIG. instrument ίο

related of transmit

can

of anvil present

mind and

handle fastening components. the tissue the

where

thereby

a 4.

a and

(12) material

be is

the secured against

rigidly

two

an use scalpel components, component

Once

accomplished

of positioned

buttress

forces.

assigned (56) and distal

annular application. section noted

generally

of those previously

severing device

may

the buttress attached grooves removed (62) and and (40),

end

otherwise,

Apart However, skilled

surgical material,

(8), be

array

buttress sealed

U.S.

is

(14). over is

of grooves

and include

made

captured

an

as material well by un-joined

(46)

fastener an

from along

of Pat.

inner in the

is stainless

squeezing Upon anastomoses. annular procedure

staples

until to the known known material present the equivalent

Nos. shaft such (46) positioning

the with

ring

within

art. on

materials head

completion

it

tissue

and

materials prior

steel scalpel as a bottoms in in the of

in

circular

(18

has would well

the the

the the

the distal

for to

&

of

art

as

2010200618 23 May 2012 20 25 30 15 10 5

positioned natural the trimming The a upon anvil actual bovine which configurations from convenient been which components, materials for be mandrels) adapted sterile such interior

hole

used preformed anvil-plate

anvil

components. used pre-soaked a components.

buttress at

and facilitates is template pericardium

Circular animal In In

non-planar as to its secured

are

to

buttress the accordance

quite designed

readily shaping be upon,

sizes

base, form

and pre-formed process positioned

buttress tissues, end portions and

successfully. stapler

and

the or required. which in the which

a

situated includes

of

Either sizes. forms

portion The ring-shaped dehydrated place

to sheet

trimming stapling tissue

the of with

mimic properly

materials.

buttress

used cartridge for

snugly

the

on

in anvil. in fixed prototype The

and the

adapted a

processed a

a either

a present

are

biomaterial procedure. circular

shape the

manner The

shaping to present

attached

animal onto fits preserved material disk

defined

form size buttress

In the processed

on

to corresponding

stapler

invention a particular,

with

stapler

and or

cartridge that

be

preformed invention, the a tissue forms

in

disc

cross-linked, by is preformed In

positioned

an includes

11 configuration and staple-firing provides place.

composed

devices the particular,

are incurvate with buttress using are

the processed,

it shapes or

typically

covered

shape

has

They it stapler

a anvil

to

a

shaping

or

both has central

by within biomaterial

the

been

materials of

a tailor-made

bovine they central

end

fixing can

using been superior face,

of

biomaterial

a

shape buttress with present the

generally

found the

the cylindrical of be forms are

discovered respectively,

staple

a

upon

pericardial the

lip the produced particular

annular of of adapted tanning

preformed buttress

that

superior which

materials

staple the respective of buttress forms

a

cartridge which planar

desired

template if invention

depression

aperture

solution. the to

cartridge.

fits

in that stapler (e.g., is tissue

properties

be

and material

all is portion produced

are buttress by

snugly

stapler certain and typically

and fixing an

formed

has are of can

The with

on

2010200618 23 May 2012 25 20 30 15 10 5

the processed. to bovine to tissues, present materials within blood. after harvested raw harvested obtained however, in describing in slaughterhouses. inspected is it limitation FIG.

is generally the the buttress accordance

materials

bovine important

collection 5

use range

72 and pericardial It In In Incoming The invention properly

from

will

in that cattle tissue of accordance hours animal accordance

inasmuch

materials, the

in

pericardial tissue harvested the of

bovine of

accordance be while with to process slaughtered

32°-55°

and

the preformed, that

after

must

preserved

appreciated

obtain tissue.

raw The results

is tissue

the invention.

the

pericardial the are as

thereafter

particularly

collection.

be pericardium with with

harvesting from

for

tissue. invention it

water/saline F.

processes high at

of has in

As is

with

(2-5° manufacturing

least animals

the the

and believed a cross-linked a United

shown

been quality that

superior minimum

This manufacture invention,

packaged The a

processed, tissue, one C.) raw

is should if

a

and used

is

and

preferred

harvested States shown

manufactured tissue at and

year solution

that starting pericardium initially

and (70) products that

quite it

size

shipped

state occur

old, other in

circular it is

Department must 12

more possess in

is in

has containers

necessary of

in

material.

is process successfully. intended FIG. which tested sacs FIG. in

the suitable within order

frequently been

meet

are successful accordance to

testing stapler

in

buttress are 5.

superior 5, arrive

described

and

have

a

to found certain

for the

two placed to preformed of

which by

The materials be

inspected

preserve

manufacturing

preferred and Agriculture buttresses for been

way

changed

hours useful

materials

material. that It starting

properties

with

minimum

processing, maintain in inspection will herein

of processed

certain

ice

of

can example for

the shape.

the be

(72)

starting

to slaughter water material using

with of processing

recognized, process

be A (USDA) condition

remove

when

a

standards natural as the

flow

buttress similarly procedure temperature

preferably In

by

immediately particularity pericardium shown and

material

invention,

particular,

it is selected chart and of

residual

comes not animal

of

the into

and in the

the that

is

2010200618 23 May 2012 25 20 30 15 10 5

tissue These approximately not test More minutes. blood, utilizing documents for environmental tissue outside After a size has CFU/gram includes includes bovine for solution, for

mounted

use) a holes, exceeded

been is (eg.

minimum

5 rinses

is performed is tests

and

At Pericardial pericardial In Pre-forming minutes

surface,

and

transferred cleared inspection 2-5 isotonic 8 assured, the

In

thick the

this

cm

the knife of are are

the may thickened, rinses. tissue,

by

pre-soak sac

x

point minimum

debris verified.

10 conducted

of

or

case

and is 8 away

the edge

on be

saline. tissue.

step

grams cm) thin 5 removed tissue tissue

of which to minutes

used, of material. before samples If in of

or

of

from

the

trays (76)

for fresh areas, the (78), the

rough

frozen

parasites,

The the representing soaking The is is This

material in in shaping has

process, material

covered then is

15

both and

containing tissue the

appropriate

but a either

of tissue

or rinses conducted

fatty

well-known is Typically, a minutes tissue,

the

peeling

placed cut,

shiny, subjected no based

sides time

cuts

into is

in

case, or

a is material is longer around are

raw,

used,

quality a the then material fibrous now

of for

or visceral

on buttress controlled in approximately on performed

or dimensions. wherein if

the the series

isotonic tears the

each

13 a

to a than ready freezer necessary,

undertaken usually manner. a

randomly

cutting to

assurance pericardial a bioburden suitable approximate tissue.

from plurality

assure

(that rinse or material. about of

for the

environment saline-rinsed inside burned cold in 1-3

board

each

would Once further

should

material

Certificates

order shaped to that

15 selected 0.25%

(80).

isotonic

or isotonic

needs of

tissue remove

surface minutes

control

The areas. quality

where the

the

0.25% saline

to not

processing. In be

device

glutaraldehyde maximum leach is quality to material

at

this

sample afford approximately

saline for

bovine

saline

cut

all

and be

Any it this

rinses number of control prior glutaraldehyde

size, part is

of

away to less origin for

a

time. again of

rinses extraneous a

the

the rinses

of dull,

pericardial to is

of at minimum the

discoloration, than the

bioburden

bioburden

die

batch. covering. any

blood. (74) appropriate the

and

inspected purpose parietal material

suffice.

normally solution cut

1.0

process, residual

30 other

using x

area

10

is or

of

8

2010200618 23 May 2012 20 25 30 15 10 5

the of over approximate diameter shaping placed tank The evacuate 0.25% smoothing, surface band the intended. illustrated For maximum gluteraldehyde assemblies forms enough

plastic

central pericardium

example,

foam

containing the (102)

are gluteraldehyde in

The A The For

of deiononized the

shaping

of the

the tubing

single

fully has

the in

of

hole.

sink is gluteraldehyde taking tissue tissue-covered 24 tissue-covered

air those

step tank,

96 a then been foam

mm prototype

solution immersed.

0.25

from in into sheet hours (100) device

1

prior

care placed the of additional

suitably and of template.

the (DI)

%

the the

of FIG. solution solution

prior (e.g.,

not

to gluteraldehyde an at (96), foam

cut

stapler fixture

was to water

further

room

inner form tanning form to The

6

affected to hold with pericardial

(96).

as 0.25 stretch

made template Wrinkles

removal.

of to

covered

to

shown temperature is components is diameter and

the

an processing. cover 0.25

cover % placed then (82),

The

using

outer

by to the edges gluteraldehyde

%

solution.

to in replace

placed the the material dimensions

in forms the the tissue

gluteraldehyde.

of in the a

14 a diameter the

of vacuum

fixtures. depth

medium tissue

fixtures a

18

for for

second

the

This lyophilizer

buttress

are in

or it

mm

a (98)

which

After

with a

force pericardium

of minimum allowed covered

lyophilizer

is

of

of when

as

(84). approximately

is density

A step should illustrated

0.25 17 the

surface

the added al the the vacuum

mm) tissue-covered

vessel of

the

material

A shaping to buttress form plastic %

FIG. foam of

then vacuum

remain to tissue

gluteraldehyde against vessel are is

48

is insure in

filled is

then

be

6.

removed pulled tubing with

hours detail placed

device, should

material 1 covered

placed

A in

filled cm. is used the

with

that

short an the pulled

forms and in

briefly

(100)

outer in

outer A

as

to with all enough FIG. by evenly

is a foam

a rubber segment solution.

force

fixation covered

manual briefly

are out

to 6.

of

2010200618 23 May 2012 25 20 30 15 10 5

to to After tissue packaged tissue support on tissue minimally. ring results (88). separated the procedure, which stored intraluminal is the accordance immersed minimally.

then

the force the

required package

to

the The

fixation (104) is is

the thereafter form the placed in

Thereafter If If

ring DI treated drained

initial a

used it

pericardium (90)

diameter 70

in

desired

the water formed

is

with

After and which is number up, stapler.

sterile

%

to

face vessels prior labeled tissue wet,

with 70 ethanol,

and the be and in

established

into

this

the

diameter.

is % down

jars portion

used

the water is

tissue

to

circularly refilled of a

can The discarded.

ethanol,

the

tissue dictated containing step, (98) and solution sterilization

now ethanol-containing filled

dry,

1% (support

be

tissue foam. containing

is

the of is a

terminally chemically is

procedures. with subsequently propylene

quality The the

with

buttress shown

by final 1% cut

subjected

of can

The

The now

DI

outer diameter

fresh

70 ring propylene evenly

70

via

inspection

then

water assurance in

tissue

% fixture 1

% chemically

material

up) e-beam % sterilized

oxide FIG. 70 diameter

fixed ethanol,

ethanol, to

placed A propylene

about

15

removed %

for and

solution is

another is

quality

containing 6.

oxide

ethanol, dictated is tissue then

15-120 and (92). (18/20) circularly

sterility

The

the drained

upon

1% of with 1% fixed

placed

release

treatment,

quality inspection desired changes. support from

is tissue oxide. propylene propylene

a γ by minutes. 1%

removed

and

-irradiation, tissue

check mounting tissue and

outer

the cut

propylene upon

to is

excess inspection. intraluminal

ring Alternatively

the

form then evenly stores

The is

tissue is is

is

diameter

oxide

a

oxide

from then inspected

conducted to then

conducted.

mounting

placed device caps

cut-away (86).

the

is which

can about oxide

vacuum

the

transferred for conducted for

desired

are The

of be

stapler. The

48

form. face if

75 to

tissue

decreases the

for torqued

desired

during required. inspected

device jarred

to pericardial this

Finally, hours

dried,

dried

down,

support

14 diameter 432

The

is

(94). back This days

and hours. while in

tissue

The

and

2010200618 23 May 2012 25 20 30 10 15 5

through “ ampicillin/sulbactam. compression anesthesia, buttress vertically reflected with units prior anvil passed approximately in Surgery, manipulation available introduced application deposited lies Y

steep ” Example

flat

connector

a of to and

45-mm to The The

Circular

positioning against low-molecular Trendelenherg two material

(Cincinnati,

caudally.

under the cartridge with on

to a by surgical stomach

trocars.

# nasogastric devices the esophageal the

in

endoscopic the 25 is 1:

ultrasonic

each the buttress

the

buttress are attached

anvil Roux-En-Y

cm end-user.

of

tradename The to

body.

steps

as is stapler

are

Ohio),

to

the

enhance

Trocars

’ approached and weight

follows. s jejunum

40

material

applied tube hiatus. position,

as

coagulating circular

to to linear

Alternatively, the

cm

a component create leaving the The

part and

Gastric

heparin “ are cartridge distal retention

PSD

insufflator

stapler After to is

anvil is Buttress

stapler catheter of

then and

a transected through the applied

EXAMPLES

a

Roux-en-Y the Gel

to

shears.

15 the and the

Bypass

lower buttress

placed the “

such and

”

manufacturing of face are a to

16

from institution greater are

an

pressure-sensitive

Material

to the ligament the to 20

is separated. ” as

extremities.

The with intravenous allow placed. a

.

in

pressed Procedure buttress cc

gastrohepatic and Biovascular, those

circular A

gastric the

omentum gastric

Roux viscous an cartridge

for

of umbilicus

of

manufactured endoscopic

Pneumatic

into

Trietz. on

carbon

general process bypass The stapler (distal

pouch.

dose The the gel Using

place

and

circular

Inc.) buttress ligment adhesive

stapler

(e.g.

patient

jejunum) dioxide

The and using of of

endotracheal

in transverse

The so Circular stapler sequential

may any place

a various

mesentery by

that

buttress

standard circular and during are patient

is diameter.

may be insufflation Ethicon

of given

the

limb then

transected applied

colon gel Stapler ports.

be

buttress

is is

stapler

mated is gel is 2,500

placed then Endo-

then

split

The are

as A

2010200618 23 May 2012 20 25 30 10 15 5

to through the proximal tube tube pouch, nasogastric and of for support appropriate buttress nasogastric has anvil under slowly lubricant, suture into support This its laparoscopic When pulled

the the

normal

the cut

passed the

the

and is instrument

slides

anvil

direct stapler

the

is free

safe, slowly advanced a nasogastric

The For

small (if in flipped the material,

then 4-mm flip

to

and tip

order

perpendicular

used)

through

and this

tube and tube, period down nasogastric small its antegrade

vision

top scissors, of anvil

tied hole the pulled

air out gastrotomy procedure, position, cartridge the

to quickly

by

of are and the

the

proximal hole

easily to

or

in of

enhance tube

is via to the the passing proximal

removed,

itself tube sump

the into anvil pulled flipped. compression, the

and

passage

in a

gastrotomy,

anvil tube

at

cuts into

laryngoscope.

tip position. the

the of abdomen.

the

where

the to this

a may port.

is nasogastric

the the

the of

out

and small distal secure are position

through anvil

abdomen, nasogastric made

tube A

point. and

the of

adhesion

needle be stapler,

through

the cut. suture anvil The

the

’ anvil (<25mm) (larger) the reattached To s is

the

the over

the

post

post, Alternatively,

pulled the stapler larger The

A in

further

are stapler

and

anvil

sutures tube

is

anvil respectively. ’ the Once silk

the

s one

the between plastic,

is tube

passed and post anvil 17

coated

end suture

inserted anvil

anvil gastric

into ’ is stitch tip

“ is of s

within

facilitate to in

is

flip

reaches out

anvil positioned and

then of

holding the

is of

then

the the

the

allowing

between

is

with

through through

a buttress top advanced the

is the

tied. the pouch. lower

guided nasogastric

opened, cartridge is esophagus, will the

abdomen.

used

ready ”

Following other

nasogastric

split the a anvil circular removing

the

nasogastric sterile After fit

abdominal

into

to the the staple one

the and

through

anvil to After with

side

snugly

until the may secure

and

esophagus.

top use.

nasogastric the side the stapler.

water-soluble

stapler tube

The

the

anvil of a

line attachment

in

the

the the be

of closed gastric harmonic tube

flip

the into of

the the the stapler

tube.

nasogastric

the introduced is trocars. tip of

anvil flip

the

and

top

tube. is transected

nasogastric oropharynx with After anvil

the

the flipped of

used onto top pouch.

tube,

tube The

foam is

from head the lumen

gastric

scalpel. of

secured The in returns an

As

a to

anvil flip

to the

the

foam into anvil tube

of

the

allow

the just

be

of

top the

to

is

2010200618 23 May 2012 25 20 30 15 10 5

portion(s) the The The tube gastrojejunal along circumferential to then This carefully centimeters scalpel. pressed example, anastamosis gastrojejunal stapler. locked improved laparoscopic retention gel

inspect

Example gastric of

fastener stapler that removed remnant

with the

onto

The The Circular into The

This

will positioning of

of buttress type

the through

pouch

the

passed

open staple

distally. the the

the

place

between

head Roux-en-Y

anastomotic anastomosis anastomosis # remain allows material, condition

from

used described

2:

anastomosis. buttress fastener buttress staplers

end

laproscopically

material Creation of

line so the

into

the

stapler.

a the the The postoperatively. that

of large

use

of larger

as

patient the

of

on the

head. are are stapler enteroenterostomy tissue

above

the

the post techniques. well

of

with is

the

is opening intestine the

Roux cut also of

tested

circular stapler Roux positioned buttress

At

tissue

of

along as a The stapler

and an may from is

Colorectal

used

this the

via circular

Buttress limb introduced endoscopic

jejunal with

firing anastomosis

in

and (>26

“ be with anvil

a stapler the point

rings

lies in during the Prior

hole

is

applied

methylene on

the colorectal

buttress

then the mm) portions

flat the Roux 18

protruding limb

” remnant

Material the

made

to is rectum. buttress for Anastomosis

stapler. directly manipulation

stapler. against

linear created

closed closing

to anvil

prior

is jejunal integrity, is

portions

be in

excised

of stapled surgery blue

buttress

the

stapler used. and

material.

This to the each with through through

The 60 It the

limb

positioning pouch infused

is

cartridge

small cm

as

procedure trocar with after positioning in

an Using customary

stapler to in

using

material

this and

to the

endoscopic create the the the

using

As bowel the

firing 100cm

through

sites, standard is

then

Circular body. gastric abdominal standard “

components in harmonic

an face to

a can a the

can

the

for and

indication several leak-proof enhance the (i.e. harmonic distal

”

Alternatively, a . previous

also

pouch be the stapler.

linear

fashion pouch, nasogastric A

discarded) Stapler

discarded

viscous

surgeon to wall. scalpel. be

and

the

is of

are

by

a

2010200618 23 May 2012 20 10 15 5

a upon and The end anoscope. After anoscope anus. After onto attachment manufacturing integrity large suture foam

pressure

fired. of

shaft

a

bowel firing support an removal

In holding foam the The In

appropriate of most

which of colorectal rectum. sensitive Positioning

Once

of the of

anvil

and support the

(if

the

the

of instances,

tissue process anastomosis

anvil

rectum allows used)

through

the

and buttress

stapler.

The

adhesive

surgery, in period obturator,

in cartridge extends

(discarded) are

order in

gradual, place. anvil are

the

the

place material, removed, This

removed of is

maneuver

to sphincter, the may

is

beyond compression, then

of the enhance of positioned remnant

controlled distal

the be gel portions

stapler assessed the

and

from deposited

stapler application the

is fastener anvil the

the material the

facilitated

end

19 shaft

the

into stapler dilation

of

adhesion

the stapler as are is

of the patient

the reattached in

on head can

anvil

connected the

as

by buttress

Example

must the

resected

of is

easily using well

intestine the

is

between is along

then the buttress

usually

be then

end-user. as

anal a to

are be

ready inserted

#1. and circular end Fansler with

the

opened,

passed with

cut

buttress as sphincter

inserted

the

of

cartridge

the to a from

a the

part Following

stapler up use.

or portions

purse-string through stapler. the

large to Chelsey-Eaton

and the through of

muscles. anvil the

and

the

is buttress stapler.

intestine.

of resected closed the The

closed and

the the

2010200618 23 May 2012 20 25 30 15 10 5

positioned the provided portion(s) component(s), prior central having recessed instrument What tissue comprises circumferential buttress center second instrument, line mandrel formed

cartridge buttress

to,

is

comprises

portion

recessed a b) a) region 4. 3. 2. 1

by

claimed

material

or . or aperture central

by

to

preformed

upon a

components, at other and

the process seal the

component the

of adapted to A one a A A A

disc

optionally, stapler aperture,

recessed the tissue circular

is:

pericardium. portion the between combination model combination time combination then combination of

or

staple having the that buttress

animal more

be of,

to site,

instrument,

shape, anvil.

c)

comprises stapler adapted includes delivered

fit aperture use, and joined

cartridge

upon

d) portions to

an the

tissue. material

to provide

b) medical according according according integral soaking

central

instrument,

delivery

permit tissue while to

the and

to

wherein a

fit and/or of

circumferential

a

steps upon

a

corresponding

the device

buttress raised

in sections recessed the tissue the first

to to to

of position

20

anvil

wrapped anvil

of claim claim removal claim activation

comprising the the region

center

site comprising: wrapping

material buttress components upon

component aperture components

2

3 1 in upon

wherein wherein wherein

of pericardium of portion combination

disc anvil

activation

of buttress

one

a the the material adapted

a

of staple having

stapler component

or

stapler comprises pericardium

the the the the adapted and

of more

material

cartridge,

pericardium preformed buttress of cartridge the

to positioned portion in an with instrument

the

instrument

be a portions stapler

integral to crosslinking

a) stapler

a the having

fit

as

material onto stably adapted

component

and the

a stapler

animal

instrument

material

staple raised

of has

knife

a central the a

a

been

to

fit

2010200618 23 May 2012 20 25 30 15 10 5

recessed comprising provided sterilizing solution, of provide the cartridge wherein the optionally, portion(s) stapler stapler adapted aperture, stapler portion anvil recessed a line

circumferential

the

circular buttress buttress

component stapler

components, component(s), instrument 5. 6. the 7. adapted

a to

the

aperture aperture

removing

and as

buttressed

to the

be

kit

d)

the stapler

material a

buttress seal

the

another instrument

plurality a) to pericardium. comprising

A A A steps

to stably

permit tissue

between combination kit comprises method disc and

of

that fit instrument the

c) the for surgical material upon

of

the portion a to having

comprises of positioned pericardium site, upon

providing the corresponding

use

cartridge,

then

prior central of

portions,

joined one activation

removal

to

in a performing

delivery

seam

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