Implantable layer comprising a constricted configuration

• US 10,478,188 B2
• Filed: 09/30/2015
• Issued: 11/19/2019
• Est. Priority Date: 09/30/2015
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Ethicon, LLC (Johnson & Johnson)
• Inventors: Harris, Jason L., Shelton, IV, Frederick E., Vendely, Michael J., Landgrebe, Susanne
• Primary Examiner(s): Lopez, Michelle
• Application Number:
  US14/871,056
• Publication Number:
  US 20170086836A1
• Time in Patent Office: 1,511 Days
• Field of Search: 2271761, 606151
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/072 for applying a row of staples in a single action , e.g. the staples being applied simultaneously
• CPC Class Codes: A61B 17/07207 the staples being applied sequentially
• CPC Class Codes: A61B 17/07292 Reinforcements for staple line, e.g. pledgets
• CPC Class Codes: A61B 17/08 Wound clamps or clips, i.e. not or only partly penetrating the tissue suture bridges A61B17/0466; Devices for bringing together the edges of a wound
• CPC Class Codes: A61B 17/105 Wound clamp magazines for packaging sharps A61B50/3001
• CPC Class Codes: A61B 17/32 Surgical cutting instruments A61B18/042 takes precedence; suture cutters A61B17/0467; instruments for ligaturing or cutting A61B17/128; instruments for rupturing the amniotic membrane A61B17/4208; specially adapted knives for eye surgery A61F9/0133
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/00831 Material properties
• CPC Class Codes: A61B 2017/00862 elastic or resilient for sutures A61B2017/0618
• CPC Class Codes: A61B 2017/00893 pharmaceutically effective
• CPC Class Codes: A61B 2017/00955 thermoplastic
• CPC Class Codes: A61B 2017/00964 composite
• CPC Class Codes: A61B 2017/07214 Stapler heads
• CPC Class Codes: A61B 2017/07221 curved
• CPC Class Codes: A61B 2017/07228 Arrangement of the staples
• CPC Class Codes: A61B 2017/07235 : containing different staples, e.g. staples of different shapes, sizes or materials
• CPC Class Codes: 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
• CPC Class Codes: A61B 2017/0725 : with settable gap between anvil and cartridge, e.g. for different staple heights at different shots
• CPC Class Codes: A61B 2017/07257 : characterised by its anvil
• CPC Class Codes: A61B 2017/07271 : characterised by its cartridge
• CPC Class Codes: A61B 2017/07278 : characterised by its sled or its staple holder
• CPC Class Codes: A61B 2017/07285 : characterised by its cutter
• CPC Class Codes: A61L 17/105 : Polyesters not covered by A61L17/12
• CPC Class Codes: A61L 17/12 : Homopolymers or copolymers of glycolic acid or lactic acid
• CPC Class Codes: A61L 2420/02 : Methods for coating medical devices
• CPC Class Codes: B05D 1/007 : using an electrostatic field B05D1/02 - B05D1/16 take precedence
• CPC Class Codes: B05D 1/30 : performed by gravity only, i.e. flow coating
• CPC Class Codes: B29C 44/3453 : Feeding the blowing agent to solid plastic material
• CPC Class Codes: B29C 44/358 : Foamed of foamable fibres
• CPC Class Codes: B29C 48/0012 : combined with shaping by internal pressure generated in the material, e.g. foaming
• CPC Class Codes: B29C 48/0022 : combined with cutting
• CPC Class Codes: B29C 48/05 : Filamentary, e.g. strands
• CPC Class Codes: B29C 48/16 : Articles comprising two or more components, e.g. co-extruded layers
• CPC Class Codes: B29L 2031/753 : Medical equipment; Accessories therefor bloodbags, medical bags B29L2031/7148; artificial eyes B29L2011/0008
• CPC Class Codes: B29L 2031/7546 : Surgical equipment
• CPC Class Codes: B32B 2250/03 : 3 layers
• CPC Class Codes: B32B 2250/40 : Symmetrical or sandwich layers, e.g. ABA, ABCBA, ABCCBA
• CPC Class Codes: B32B 2307/50 : having particular mechanical properties
• CPC Class Codes: B32B 2307/54 : Yield strength; Tensile strength
• CPC Class Codes: B32B 2307/72 : Density
• CPC Class Codes: B32B 2307/732 : Dimensional properties
• CPC Class Codes: B32B 2307/736 : Shrinkable
• CPC Class Codes: B32B 2535/00 : Medical equipment, e.g. bandage, prostheses, catheter medical patches B32B2556/00
• CPC Class Codes: B32B 3/02 : characterised by features of form at particular places, e.g. in edge regions non-uniform thickness B32B3/263
• CPC Class Codes: B32B 3/08 : characterised by added members at particular parts layer formed of separate pieces of material which are juxtaposed side-by-side B32B3/14, B32B3/18
• CPC Class Codes: B32B 3/20 : of hollow pieces, e.g. tubes; of pieces with channels or cavities
• CPC Class Codes: B32B 3/266 : characterised by an apertured layer, the apertures going through the whole thickness of the layer, e.g. expanded metal, perforated layer, slit layer regular cells B32B3/12
• CPC Class Codes: B32B 5/024 : Woven fabric
• CPC Class Codes: B32B 5/026 : Knitted fabric
• CPC Class Codes: B32B 5/10 : characterised by a fibrous or filamentary layer reinforced with filaments
• CPC Class Codes: B32B 5/12 : characterised by the relative arrangement of fibres or filaments of different layers, e.g. the fibres or filaments being parallel or perpendicular to each other
• CPC Class Codes: B32B 5/18 : characterised by features of a layer of foamed material
• CPC Class Codes: B32B 5/245 : another layer next to it being a foam layer
• CPC Class Codes: B32B 5/26 : another layer next to it also being fibrous or filamentary relative arrangement of fibres or filaments of different layers B32B5/12
• CPC Class Codes: B32B 7/05 : the layers not being connected over the whole surface, e.g. discontinuous connection or patterned connection using interposed adhesives or bonding materials applied in spaced arrangements B32B7/14
• CPC Class Codes: D01D 5/0023 : the material being a polymer melt
• CPC Class Codes: D01D 5/18 : by means of rotating spinnerets
• CPC Class Codes: D04H 1/565 : by melt-blowing
• CPC Class Codes: D10B 2331/041 : derived from hydroxy-carboxylic acids, e.g. lactones
• CPC Class Codes: D10B 2509/00 : Medical; Hygiene

Abstract

A staple cartridge assembly is disclosed which comprises a cartridge body and an implantable layer. The implantable layer includes fibers comprised of a first material and a second material. The first material and the second material have different glass transition temperatures. After the fibers comprised of the first material and the second material have been intermixed or interwoven, the layer is exposed to a temperature which exceeds the lower of the two glass transition temperatures. This heating process causes the layer to constrict and increase in thickness. The layer, when implanted, can compensate for variations in tissue thickness within the staples.

Claims

1. A staple cartridge assembly, comprising:

a cartridge body comprising a deck;

a plurality of staples; and

an implantable layer positioned over said deck, wherein said implantable layer comprises;

a first plurality of fibers comprised of a first material having a first thermal transition temperature, wherein said first fibers are interconnected at a plurality of nodes, wherein said plurality of nodes define a plane, and wherein said plurality of nodes is configured to reinforce a three-dimensional structure of said implantable layer; and

a second plurality of fibers comprised of a second material having a second thermal transition temperature, wherein said second thermal transition temperature is lower than said first thermal transition temperature, wherein said second material is intermixed with said first material, wherein said second fibers are contracted within said implantable layer during a process which exposes said implantable layer to a process temperature which exceeds said second thermal transition temperature, and wherein a first portion of said second fibers are constricted at said plurality at nodes and a second portion of said second fibers are laterally expanded away from said plane.

2. The staple cartridge assembly of claim 1, wherein said second plurality of fibers are arranged in a structural lattice frame, and wherein said structural lattice frame contracts during said process.

3. The staple cartridge assembly of claim 2, wherein said second material comprises polydioxanone.

4. The staple cartridge assembly of claim 3, wherein said first material comprises polyglycolic acid.

5. The staple cartridge assembly of claim 1, wherein said implantable layer is part of an implantable layer assembly which further comprises a laminate film.

6. The staple cartridge assembly of claim 1, wherein said process temperature is less than said first thermal transition temperature.

7. A staple cartridge assembly, comprising:

a cartridge body comprising a deck;

a plurality of staples; and

an implantable layer positioned over said deck, wherein said implantable layer comprises;

a mesh comprised of a first plurality of fibers comprised of a first material having a first thermal transition temperature; and

a second plurality of fibers comprised of a second material having a second thermal transition temperature, wherein said first thermal transition temperature is lower than said second thermal transition temperature, wherein said second plurality of fibers are attached to one another at a plurality of nodes, wherein said plurality of nodes defines a plane, wherein said plurality of nodes is configured to reinforce a three-dimensional structure of said implantable layer, wherein said second plurality of fibers are interwoven with said mesh, wherein a first portion of said mesh is constricted at said plurality of nodes during a process which exposes said implantable layer to a process temperature which exceeds said first thermal transition temperature, and wherein said plurality of nodes define peaks and valleys at an exterior surface of said implantable layer.

8. The staple cartridge assembly of claim 7, wherein said first material comprises polydioxanone.

9. The staple cartridge assembly of claim 8, wherein said second material comprises polyglycolic acid.

10. The staple cartridge assembly of claim 7, wherein said implantable layer is part of an implantable layer assembly which further comprises a laminate film.

11. The staple cartridge assembly of claim 7, wherein said process temperature is less than said second thermal transition temperature.

12. A staple cartridge assembly, comprising:

a cartridge body comprising a deck;

a plurality of staples; and

an implantable layer positioned over said deck, wherein said implantable layer comprises;

a first plurality of fibers comprised of a first material having a first glass transition temperature, wherein said first fibers are interwoven to one another at a plurality of nodes, and wherein said plurality of nodes is configured to reinforce a three-dimensional structure of said implantable layer; and

a second plurality of fibers comprised of a second material having a second glass transition temperature, wherein said second glass transition temperature is lower than said first glass transition temperature, wherein said second material is interwoven with said first material, and wherein said second glass transition temperature has been previously exceeded defining valleys at said plurality of nodes and peaks between said plurality of nodes.

13. The staple cartridge assembly of claim 12, wherein said first material comprises polyglycolic acid.

14. The staple cartridge assembly of claim 13, wherein said second material comprises polydioxanone.

15. The staple cartridge assembly of claim 12, wherein said implantable layer is part of an implantable layer assembly which further comprises a laminate film.

16. A method of manufacturing an implantable layer, said method comprising the steps of:

obtaining first fibers comprised of a first material having a first thermal transition temperature, wherein said first fibers are connected to one another at a plurality of nodes, wherein said plurality of nodes defines a plane, and wherein said plurality of nodes is configured to reinforce a three-dimensional structure of said implantable layer;

obtaining second fibers comprised of a second material having a second thermal transition temperature, wherein said second thermal transition temperature is lower than said first thermal transition temperature;

intermixing said first fibers with said second fibers; and

heating said second fibers to a processing temperature which exceeds said second thermal transition temperature so that said second fibers contract after said intermixing step, wherein said heating step constricts a first portion of said second fibers at said plurality of nodes, and wherein said heating step laterally expands a second portion of said second fibers away from said plane.

17. The method of claim 16, wherein said intermixing step comprises interweaving said first fibers and said second fibers.

18. The method of claim 16, wherein said processing temperature does not exceed said first thermal transition temperature.

19. The method of claim 16, wherein said intermixing step comprises interweaving said first fibers into a mesh of said second fibers.