# US 10,499,913 B2 · Tubular surgical constructs including adjunct material

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- Number: US 10,499,913 B2
- Document ID: US10499913B2
- Status: Granted
- Kind: B2
- Application number: 14/841,060
- Filed: 2015-08-31
- Published: 2017-03-02
- Granted: 2019-12-10
- Earliest claimed: 2015-08-31
- Assignees: Ethicon, Inc.
- Applicants: Ethicon Endo-Surgery, LLC
- Inventors: Michael J. Vendely; Frederick E. Shelton, IV; Jason L. Harris
- Web page: https://patentgrep.com/patent/US10499913B2

## CPC

- A61B 17/07207: {the staples being applied sequentially}
- A61B 17/07292: {Reinforcements for staple line, e.g. pledgets}
- A61B 17/1114: {of the digestive tract, e.g. bowels or oesophagus}
- A61B 17/1155: {Circular staplers comprising a plurality of staples}
- A61B 17/1219: {expandable in contact with liquids}
- A61F 2/04: Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts (A61F2/18, A61F2/20 take precedence; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95)
- A61L 31/08: Materials for coatings
- A61L 31/146: {Porous materials, e.g. foams or sponges}
- A61L 31/16: Biologically active materials, e.g. therapeutic substances {(A61L31/047 takes precedence)}
- A61M 37/00: Other apparatus for introducing media into the body (for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30); Percutany, i.e. introducing medicines into the body by diffusion through the skin (salt baths A61H33/04)
- A61B 2017/00004: {(bio)absorbable, (bio)resorbable or resorptive}
- A61B 2017/00884: {enhancing wound closure}
- A61B 2017/00889: {antimicrobial, disinfectant}
- A61B 2017/00893: {pharmaceutically effective}
- A61B 2017/07271: {characterised by its cartridge}
- A61B 2017/07285: {characterised by its cutter}
- A61B 2017/1132: {End-to-end connections}
- A61B 2017/12004: {for haemostasis, for prevention of bleeding}
- A61F 2002/044: {Oesophagi or esophagi or gullets}
- A61F 2002/045: {Stomach, intestines}
- A61L 2300/412: Tissue-regenerating or healing or proliferative agents
- A61L 2300/602: Type of release, e.g. controlled, sustained, slow
- A61L 2300/606: Coatings
- A61M 2205/04: implanted
- A61M 2210/105: Oesophagus
- A61M 2210/106: Small intestine
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

Tubular surgical constructs including adjunct material are provided. In general, a tubular construct can be configured to be applied to tissue of a patient. The tubular construct can be configured to be implantable and to be implanted within a tissue lumen. The tubular construct can be configured to radially expand and radially constrict. The tubular construct can have an adjunct material disposed thereon. The adjunct can have one or more medicants releasably retained therein. Each of the one or more medicants can be effective to provide a desired effect on tissue in a predetermined manner.

## Claims

### Claim 1

A method of using a surgical device comprising
a tubular construct having an inner lumen extending therethrough, the tubular construct being configured to be delivered to a tissue lumen and be positioned therein so as to provide structural support to the tissue lumen, the tubular construct being radially collapsible, and the tubular construct including a scaffold that includes a plurality of circumferential rings and a support member that attaches the circumferential rings together and that holds each of the rings in a substantially constant axial position along a longitudinal axis of the tubular construct,
a biocompatible adjunct material disposed on the tubular construct, the adjunct material being configured to be delivered to the tissue lumen with the tubular construct, and
an effective amount of at least one medicant disposed within and releasable from the adjunct material, each of the at least one medicants being effective to provide a desired effect on tissue in a predetermined manner,
the method comprising:
positioning a circular surgical stapler at a target location within a patient within a lumen of a tissue of the patient, the stapler having releasably coupled to a distal end thereof the tubular construct having the adjunct material disposed thereon;
with the stapler positioned at the target location, actuating the stapler to deploy staples from the stapler and into the tissue, the deployed staples securing the tubular construct within the lumen of the tissue; and
removing the stapler from the patient, the tubular construct remaining within the lumen.

### Claim 2 (depends on 1)

The method of claim 1, wherein the adjunct material is in the form of at least one of a fiber lattice and a film.

### Claim 3 (depends on 1)

The method of claim 1, wherein the scaffold has a plurality of pores configured to facilitate tissue ingrowth.

### Claim 4 (depends on 1)

The method of claim 1, wherein the tubular construct includes a funnel shape with a smaller diameter at a first end of the shape than at a second, opposite end of the shape.

### Claim 5 (depends on 1)

The method of claim 1, wherein the tubular construct includes first and second independent tubular members;
prior to the actuation of the stapler, the first tubular member is releasably retained on an anvil of the stapler and the second tubular member is releasably retained on an cartridge assembly of the stapler; and
the actuation releases the first tubular member from the anvil and releases the second tubular member from the cartridge assembly.

### Claim 6 (depends on 1)

The method of claim 1, wherein the adjunct material is in the form of a fiber lattice having at least two distinct heterogeneous fiber lattice sections, the at least two distinct heterogeneous fiber lattice sections including a first fiber lattice section having fibers extending along a longitudinal axis of the tubular construct and a second fiber lattice section having fibers extending annularly around the longitudinal axis of the tubular construct, the longitudinal axis of the tubular construct being substantially parallel to a longitudinal axis of the lumen having the tubular construct secured therein.

### Claim 7 (depends on 1)

The method of claim 1, wherein the tissue includes one of an intestine and an esophagus.

### Claim 8 (depends on 1)

The method of claim 1, wherein the adjunct material covers an exterior surface of the scaffold and does not cover at least a portion of an interior surface of the scaffold such that the support member is not exposed on the exterior surface and is exposed on the at least the portion of an interior surface to facilitate tissue growth when the tubular construct is within the lumen.

### Claim 9 (depends on 1)

The method of claim 1, wherein deploying the staples causes the staples to pierce through the tubular construct and the adjunct material.

### Claim 10

A method of using an end effector comprising
a cartridge assembly having a cartridge body removably attached thereto, the cartridge body having on a tissue-facing surface thereof a plurality of annularly-arranged staple cavities configured to seat staples therein,
an anvil having a plurality of annularly-arranged staple forming cavities formed on a tissue-facing surface thereof, at least one of the cartridge assembly and the anvil being movable relative to the other,
a tubular construct releasably retained on each of the cartridge assembly and the anvil, the tubular construct having an inner lumen extending therethrough, the tubular construct being configured to be delivered to a tissue lumen by deployment of the staples in the cartridge body, the tubular construct being radially collapsible, and the tubular member including a scaffold that includes a plurality of circumferential rings and a support member that attaches the circumferential rings together and that holds each of the rings in a substantially constant axial position along a longitudinal axis of the tubular construct,
a biocompatible adjunct material disposed on the tubular construct, the adjunct material being configured to be delivered to the tissue lumen with the tubular construct, and
an effective amount of at least one medicant disposed within and releasable from the adjunct material, each of the at least one medicants being effective to provide a desired effect on tissue in a predetermined manner,
the method comprising:
positioning a circular surgical stapler at a target location within a patient within a lumen of a tissue of the patient, the stapler having the end effector at a distal end thereof;
with the stapler positioned at the target location, actuating the stapler to deploy the staples from the cartridge body and into the tissue, the deployed staples securing the tubular construct within the lumen of the tissue; and
removing the stapler from the patient, the tubular construct remaining within the lumen.

### Claim 11 (depends on 10)

The method of claim 10, wherein the adjunct material is in the form of at least one of a fiber lattice and a film.

### Claim 12 (depends on 10)

The method of claim 10, wherein the scaffold has a plurality of pores configured to facilitate tissue ingrowth.

### Claim 13 (depends on 10)

The method of claim 10, wherein the tubular construct includes a funnel shape with a smaller diameter at a first end of the shape than at a second, opposite end of the shape.

### Claim 14 (depends on 10)

The method of claim 10, wherein the tubular construct includes first and second independent tubular members.

### Claim 15 (depends on 14)

The method of claim 14, wherein the first tubular member is releasably retained on the anvil, and the second tubular member is releasably retained on the cartridge assembly.

### Claim 16 (depends on 10)

The method of claim 10, wherein the adjunct material is in the form of a fiber lattice having at least two distinct heterogeneous fiber lattice sections, the at least two distinct heterogeneous fiber lattice sections including a first fiber lattice section having fibers extending along a longitudinal axis of the tubular construct and a second fiber lattice section having fibers extending annularly around the longitudinal axis of the tubular construct, the longitudinal axis of the tubular construct being substantially parallel to a longitudinal axis of the lumen having the tubular construct secured therein.

### Claim 17 (depends on 10)

The method of claim 10, wherein the tissue includes one of an intestine and an esophagus.

### Claim 18

A method of using a surgical device comprising
a tubular construct having an inner lumen extending therethrough, the tubular construct being configured to be delivered to a tissue lumen and be positioned therein so as to provide structural support to the tissue lumen, the tubular construct being radially collapsible,
a biocompatible adjunct material disposed on the tubular construct, the adjunct material being configured to be delivered to the tissue lumen with the tubular construct, and
an effective amount of at least one medicant disposed within and releasable from the adjunct material, each of the at least one medicants being effective to provide a desired effect on tissue in a predetermined manner,
the method comprising:
positioning a circular surgical stapler at a target location within a patient within a lumen of a tissue of the patient, the stapler having releasably coupled to a distal end thereof the tubular construct having the adjunct material disposed thereon;
with the stapler positioned at the target location, actuating the stapler to deploy staples from the stapler and into the tissue, the deployed staples securing the tubular construct within the lumen of the tissue, wherein deploying the staples causes the staples to pierce through the tubular construct and the adjunct material; and
removing the stapler from the patient, the tubular construct remaining within the lumen.
