# US 12,213,666 B2 · Tissue thickness compensator comprising layers

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- Number: US 12,213,666 B2
- Document ID: US12213666B2
- Status: Granted
- Kind: B2
- Application number: 17/745,110
- Filed: 2022-05-16
- Published: 2022-10-27
- Granted: 2025-02-04
- Earliest claimed: 2010-09-30
- Assignees: Cilag GmbH International
- Applicants: Cilag GmbH International
- Inventors: Frederick E. Shelton, IV; Tamara S. Widenhouse; Mark D. Timmer; Steven G. Hall; Richard W. Timm; Matthew M. Lang
- Web page: https://patentgrep.com/patent/US12213666B2

## CPC

- A61B 17/0643: {with separate closing member, e.g. for interlocking with staple}
- A61B 17/00234: {for minimally invasive surgery (A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence)}
- A61B 17/00491: {Surgical glue applicators}
- A61B 17/064: Surgical staples, {i.e. penetrating the tissue}
- A61B 17/0644: {penetrating the tissue, deformable to closed position}
- A61B 17/068: Surgical staplers {, e.g. containing multiple staples or clamps}({staplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105;} for performing anastomosis A61B17/115; {staplers in general B25C5/00})
- A61B 17/072: for applying a row of staples in a single action, e.g. the staples being applied simultaneously
- A61B 17/07207: {the staples being applied sequentially}
- A61B 17/07292: {Reinforcements for staple line, e.g. pledgets}
- A61B 17/105: {Wound clamp magazines (for packaging sharps A61B50/3001)}
- A61B 17/1155: {Circular staplers comprising a plurality of staples}
- A61B 17/2909: {Handles}
- A61B 90/92: coded with colour
- A61B 17/295: combined with cutting implements
- A61B 50/30: Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments (for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40)
- A61B 2017/00004: {(bio)absorbable, (bio)resorbable or resorptive}
- A61B 2017/003: {Steerable}
- A61B 2017/00314: {Separate linked members}
- A61B 2017/00327: {with actuating members moving in opposite directions}
- A61B 2017/00473: {Distal part, e.g. tip or head (A61B2017/00464 takes precedence)}
- A61B 2017/00477: {Coupling (A61B2017/0046 takes precedence)}
- A61B 2017/00495: {for two-component glue}
- A61B 2017/00526: {Methods of manufacturing}
- A61B 2017/0053: {Loading magazines or sutures into applying tools}
- A61B 2017/00818: {Treatment of the gastro-intestinal system}
- A61B 2017/00862: {elastic or resilient}
- A61B 2017/00884: {enhancing wound closure}
- A61B 2017/00889: {antimicrobial, disinfectant}
- A61B 2017/00893: {pharmaceutically effective}
- A61B 2017/00898: {expandable upon contact with fluid}
- A61B 2017/00942: {hydrophilic}
- A61B 2017/0641: {having at least three legs as part of one single body}
- A61B 2017/07214: {Stapler heads}
- A61B 2017/07221: {curved}
- A61B 2017/07228: {Arrangement of the staples}
- A61B 2017/07235: {containing different staples, e.g. staples of different shapes, sizes or materials}
- A61B 2017/07242: {achieving different staple heights during the same shot, e.g. using an anvil anvil having different heights or staples of different sizes}
- A61B 2017/0725: {with settable gap between anvil and cartridge, e.g. for different staple heights at different shots}
- A61B 2017/07257: {characterised by its anvil}
- A61B 2017/07264: {characterised by its staple forming cavities, e.g. geometry or material}
- A61B 2017/07271: {characterised by its cartridge}
- A61B 2017/07278: {characterised by its sled or its staple holder}
- A61B 2017/07285: {characterised by its cutter}
- A61B 2017/2902: {characterized by features of the actuating rod}
- A61B 2017/2908: {Multiple segments connected by articulations}
- A61B 2017/291: {the position of the handle being adjustable with respect to the shaft}
- A61B 2017/2919: {details of linkages or pivot points}
- A61B 2017/292: {connection of actuating rod to handle, e.g. ball end in recess}
- A61B 2017/2923: {Toothed members, e.g. rack and pinion}
- A61B 2017/2927: {the angular position of the head being adjustable with respect to the shaft}
- A61B 2017/2931: {with releasable head}
- A61B 2017/2933: {camming or guiding means}
- A61B 2017/2936: {Pins in guiding slots}
- A61B 2017/2946: {Locking means}
- A61B 2017/320052: {Guides for cutting instruments}
- A61B 2050/3008: {having multiple compartments}
- A61B 2050/314: {Flexible bags or pouches}
- A61B 2090/037: {with a frangible part, e.g. by reduced diameter}
- A61B 2090/0801: {Prevention of accidental cutting or pricking}
- A61B 2090/0807: {Indication means}
- A61B 2090/0811: {for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument}
- A61B 2090/0814: {Preventing re-use}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

In various embodiments, a tissue thickness compensator can comprise a compressible extracellular matrix and a bioabsorbable material dispersed within the extracellular matrix, wherein the bioapsorption of the bioabsorbable material is configured to leave behind channels in the extracellular matrix. The tissue thickness compensator can also comprise generation means for generating the ingrowth of tissue into the channels. In at least one embodiment, the tissue thickness compensator can comprise dissolvable wicking members which, when dissolved, can leave behind channels in the tissue thickness compensator. In certain embodiments, the tissue thickness compensator can comprise at least one rupturable capsule.

## Claims

### Claim 1

A staple cartridge, comprising:
a cartridge body, comprising:
a deck comprising a top surface; and
a plurality of staple cavities defined in said deck;
a plurality of staples removably stored in said staple cavities, wherein each staple of said plurality of staples comprises a base and legs extending from said base;
a plurality of staple drivers movable from an unfired position to a fired position during a staple firing stroke to eject said staples from said staple cavities and implant said staples into patient tissue;
a sled movable from a proximal position to a distal position during said staple firing stroke to move said staple drivers from said unfired position to said fired position; and
a tissue thickness compensator removably attached to said top surface of said deck, wherein said legs move through said tissue thickness compensator as said staples are ejected from said staple cavities, wherein implanting said staples into said patient tissue secures said tissue thickness compensator to said patient tissue, and wherein said tissue thickness compensator comprises:
a first layer having a first rate of bioabsorption and a first density, wherein pressing said tissue thickness compensator against said patient tissue prior to ejecting said staples causes said first layer to transition from a first uncompressed height to a first compressed height; and
a second layer having a second rate of bioabsorption and a second density, wherein said second rate of bioabsorption is greater than said first rate of bioabsorption, wherein pressing said tissue thickness compensator against said patient tissue prior to ejecting said staples causes said second layer to transition from a second uncompressed height to a second compressed height, wherein said first uncompressed height is greater than said second uncompressed height, wherein said second density is greater than said first density such that said first layer is more compressible than said second layer, and wherein said first compressed height is greater than said second compressed height such that a larger portion of each said leg is exposed to said first layer compared to said second layer after said staples are initially implanted into said patient tissue.

### Claim 2 (depends on 1)

The staple cartridge of claim 1, wherein said first layer comprises a plurality of apertures defined therein, wherein each aperture of said plurality of apertures is aligned with at least one of said legs when said tissue thickness compensator is attached to said top surface of said deck, and wherein said apertures support said legs during said firing stroke.

### Claim 3 (depends on 1)

The staple cartridge of claim 1, wherein at least one of said first layer and said second layer comprises a lubricant that is exposed to said legs during said firing stroke.

### Claim 4 (depends on 1)

The staple cartridge of claim 1, wherein said cartridge body further comprises a plurality of projections extending from said top surface of said deck, wherein each projection of said plurality of projections is proximate to one of said staple cavities, and wherein each projection of said plurality of projections supports one of said legs of said staples when said staples are ejected from said staple cavities.

### Claim 5 (depends on 1)

The staple cartridge of claim 1, wherein said cartridge body further comprises projections extending from said top surface and into said tissue thickness compensator, and wherein said projections releasably hold said tissue thickness compensator to said top surface of said deck.

### Claim 6 (depends on 5)

The staple cartridge of claim 5, wherein said projections are configured to minimize lateral distortion of said tissue thickness compensator when said tissue thickness compensator is attached to said top surface.

### Claim 7 (depends on 1)

The staple cartridge of claim 1, wherein said cartridge body further comprises a longitudinal row of teeth extending from said top surface of said deck, and wherein said longitudinal row of teeth releasably hold said tissue thickness compensator to said top surface of said deck.

### Claim 8

A staple cartridge, comprising:
a cartridge body, comprising:
a deck comprising a top surface; and
a plurality of staple cavities defined in said deck;
a plurality of staples removably stored in said staple cavities, wherein each said staple of said plurality of staples comprises a base and legs extending from said base;
a plurality of staple drivers movable from an unfired position to a fired position during a staple firing stroke to eject said staples from said staple cavities and implant said staples into patient tissue;
a sled movable from a proximal position to a distal position during said staple firing stroke to move said staple drivers from said unfired position to said fired position; and
a tissue thickness compensator removably attached to said top surface of said deck, wherein said legs move through said tissue thickness compensator as said staples are ejected from said staple cavities, wherein implanting said staples into said patient tissue secures said tissue thickness compensator to said patient tissue, and wherein said tissue thickness compensator comprises:
a first layer having a first rate of bioabsorption, a first density, and a first uncompressed height, wherein a first portion of each said leg is exposed to said first layer when said staples are ejected from said staple cavities; and
a second layer having a second rate of bioabsorption, a second density, and a second uncompressed height, wherein said second rate of bioabsorption is greater than said first rate of bioabsorption, wherein said first uncompressed height is greater than said second uncompressed height, wherein said second density is greater than said first density such that said first layer is more compressible than said second layer, wherein a second portion of each said leg is exposed to said second layer when said stapes are ejected from said staple cavities, and wherein said first portion is larger than said second portion.

### Claim 9 (depends on 8)

The staple cartridge of claim 8, wherein said first layer comprises a plurality of apertures defined therein, wherein each aperture of said plurality of apertures is aligned with at least one of said legs when said tissue thickness compensator is attached to said top surface of said deck, and wherein said apertures support said legs during said firing stroke.

### Claim 10 (depends on 8)

The staple cartridge of claim 8, wherein at least one of said first layer and said second layer comprises a lubricant that is exposed to said legs during said firing stroke.

### Claim 11 (depends on 8)

The staple cartridge of claim 8, wherein said cartridge body further comprises a plurality of projections extending from said top surface of said deck, wherein each projection of said plurality of projections is proximate to one of said staple cavities, and wherein each projection of said plurality of projections supports one of said legs of said staples when said staples are ejected from said staple cavities.

### Claim 12 (depends on 8)

The staple cartridge of claim 8, wherein said cartridge body further comprises projections extending from said top surface and into said tissue thickness compensator, and wherein said projections releasably hold said tissue thickness compensator to said top surface of said deck.

### Claim 13 (depends on 12)

The staple cartridge of claim 12, wherein said projections are configured to minimize lateral distortion of said tissue thickness compensator when said tissue thickness compensator is attached to said top surface.

### Claim 14 (depends on 8)

The staple cartridge of claim 8, wherein said cartridge body further comprises a longitudinal row of teeth extending from said top surface of said deck, and wherein said longitudinal row of teeth releasably hold said tissue thickness compensator to said top surface of said deck.

### Claim 15

A surgical staple cartridge, comprising:
a cartridge body, comprising:
a deck comprising a top surface; and
a plurality of staple cavities defined in said deck;
a plurality of staples removably stored in said staple cavities, wherein each said staple of said plurality of staples comprises a base and legs extending from said base;
a plurality of staple drivers movable from an unfired position to a fired position during a staple firing stroke to eject said staples from said staple cavities and implant said staples into patient tissue;
a sled movable from a proximal position to a distal position during said staple firing stroke to move said staple drivers from said unfired position to said fired position; and
a compressible adjunct removably attached to said top surface of said deck, wherein said legs move through said compressible adjunct as said staples are ejected from said staple cavities, wherein implanting said staples into said patient tissue secures said compressible adjunct to said patient tissue, and wherein said compressible adjunct comprises:
a first layer having a first rate of bioabsorption, a first density, and a first uncompressed height; and
a second layer having a second rate of bioabsorption, a second density, and a second uncompressed height, wherein said second rate of bioabsorption is greater than said first rate of bioabsorption, wherein said first uncompressed height is greater than said second uncompressed height, wherein said second density is greater than said first density, and wherein a larger portion of each said leg is exposed to said first layer relative to said second layer after said staples are initially implanted into said patient tissue.

### Claim 16 (depends on 15)

The surgical staple cartridge of claim 15, wherein said first layer comprises a plurality of apertures defined therein, wherein each aperture of said plurality of apertures is aligned with at least one of said legs when said compressible adjunct is attached to said top surface of said deck, and wherein said apertures support said legs during said firing stroke.

### Claim 17 (depends on 15)

The surgical staple cartridge of claim 15, wherein at least one of said first layer and said second layer comprises a lubricant that is exposed to said legs during said firing stroke.

### Claim 18 (depends on 15)

The surgical staple cartridge of claim 15, wherein said cartridge body further comprises a plurality of projections extending from said top surface of said deck, wherein each projection of said plurality of projections is proximate to one of said staple cavities, and wherein each projection of said plurality of projections supports one of said legs of said staples when said staples are ejected from said staple cavities.

### Claim 19 (depends on 15)

The surgical staple cartridge of claim 15, wherein said cartridge body further comprises projections extending from said top surface and into said compressible adjunct, and wherein said projections releasably hold said compressible adjunct to said top surface of said deck.

### Claim 20 (depends on 19)

The surgical staple cartridge of claim 19, wherein said projections are configured to minimize lateral distortion of said compressible adjunct when said compressible adjunct is attached to said top surface.

### Claim 21 (depends on 15)

The surgical staple cartridge of claim 15, wherein said cartridge body further comprises a longitudinal row of teeth extending from said top surface of said deck, and wherein said longitudinal row of teeth releasably hold said compressible adjunct to said top surface of said deck.

### Claim 22 (depends on 1)

The staple cartridge of claim 1, wherein said first layer structurally supports said staples after said staples are implanted into said patient tissue and after said second layer is bioabsorbed.

### Claim 23 (depends on 8)

The staple cartridge of claim 8, wherein said first layer structurally supports said staples after said staples are implanted into said patient tissue and after said second layer is bioabsorbed.

### Claim 24 (depends on 15)

The surgical staple cartridge of claim 15, wherein said first layer structurally supports said staples after said staples are implanted into said patient tissue and after said second layer is bioabsorbed.

### Claim 25 (depends on 22)

The staple cartridge of claim 22, wherein said first layer expands after said staples are implanted into said patient tissue.

### Claim 26 (depends on 23)

The staple cartridge of claim 23, wherein said first layer expands after said staples are implanted into said patient tissue.

### Claim 27 (depends on 24)

The surgical staple cartridge of claim 24, wherein said first layer expands after said staples are implanted into said patient tissue.