Systems and methods for tissue removal

Patent metadata

Field	Value
Publication number	US-11744612-B2
Application number	US-202016773639-A
Country	US
Kind code	B2
Filing date	Jan 27, 2020
Priority date	Apr 23, 2015
Publication date	Sep 5, 2023
Grant date	Sep 5, 2023

Abstract

A guard for providing a cut-resistant pathway through a body orifice or incision to circumferentially protect tissue at the margin is provided. The guard is made of flexible, cut-resistant mesh material having a plurality of interwoven thermosetting filaments. The guard has a central lumen and at least one flared end. The flared end, which serves to anchor the guard in the body opening, is deformable into a reduced configuration to facilitate its insertion and removal. The layer of mesh stretches laterally to increase the diameter of the central lumen. The flexibility and expandability of the guard allows the guard to conform to body openings of different sizes. The guard may include a drawstring to cinch the flared distal end from the proximal end. The guard is thermoset with the flared distal end that is biased to spring back to its normal, undeformed configuration when released from a deformed configuration.

First claim

We claim:

1. A method for manufacturing a tissue guard to provide a pathway through a body opening, the method comprising the steps of:
providing a mesh sleeve of material having a plurality of interwoven filaments defining interstices, the plurality of interwoven filaments being formed of a plastically deformable heat setting material; the mesh sleeve being substantially cylindrical in shape having a central lumen extending along a longitudinal axis between a proximal opening at a proximal end and a distal opening at a distal end;
providing a mandrel having at least one outwardly flared flange;
mounting the mesh sleeve onto the mandrel;
annealing the mesh sleeve while the mesh sleeve is mounted onto the mandrel; and
removing the mesh sleeve from the mandrel;
the method further comprising the step of folding the mesh sleeve so as to create a double-layered sleeve of mesh material circumferentially enclosing the central lumen of the mesh sleeve; the folding step creating a fold at the distal end of the mesh sleeve with a first end and a second end of the mesh sleeve being adjacent to each other at the proximal end of the mesh sleeve, wherein the folding step is carried out prior to the step of mounting the mesh sleeve onto the mandrel.

2. The method of claim 1 wherein the plurality of interwoven filaments are made of thermosetting polymer filaments having a glass transition temperature; wherein the annealing step is performed at the glass transition temperature of the thermosetting polymer filaments.

3. The method of claim 1 wherein the annealing step further comprises the step of plastically deforming the plurality of interwoven filaments such that the mesh sleeve is molded and heat set so as to substantially conform to a shape of the mandrel when the mesh sleeve is removed from the mandrel.

4. The method of claim 1 wherein the plastically deformable heat setting material of the interwoven filaments provides the mesh sleeve with memory retention such that when the mesh sleeve is deformed and subsequently released it springs back to its original, undeformed shape.

5. The method of claim 1 wherein the mesh sleeve is mounted onto the mandrel such that the mandrel is located inside the central lumen and the mesh sleeve encompasses the mandrel.

6. The method of claim 1 further comprising the step of providing a ring adhered to the proximal end of the mesh sleeve after removing the mesh sleeve from the mandrel; the ring encompassing the proximal end of the mesh sleeve so as to cover the first and second ends of the plurality of interwoven filaments at the proximal end of the mesh sleeve; wherein the ring is formed by injection molding, extrusion molding or is molded over the proximal end of the mesh sleeve.

7. The method of claim 1 further comprising the step of heat sealing the proximal end of the mesh sleeve after removing the mesh sleeve from the mandrel; the heat sealing being performed using a hot tool for sealing the first and second ends of the plurality of interwoven filaments at the proximal end of the mesh sleeve.

8. The method of claim 1 further comprising the step of laying a bead of sealant or caulking along the proximal end of the mesh sleeve after removing the mesh sleeve from the mandrel; the bead encompassing the proximal end of the mesh sleeve so as to cover the first and second ends of the plurality of interwoven filaments at the proximal end of the mesh sleeve.

9. The method of claim 1 further comprising the step of providing a pull-wire at the distal end of the mesh sleeve to reduce a lateral dimension of the distal end of the mesh sleeve when the pull-wire is pulled and to return to an expanded relaxed configuration when the pull-wire is released, wherein the step of providing a pull-wire comprises the step of weaving the pull-wire circumferentially around the distal end of the mesh sleeve.

10. The method of claim 1 wherein the step of providing a mandrel comprises providing a mandrel having a first part removably interconnected to a second part; the first part having a first outwardly flared flange and the second part having a second outwardly flared flange; the mandrel further comprising a neck portion interconnecting the first and second outwardly flared flanges.

11. The method of claim 10 wherein the first and second outwardly flared flanges form respectively a first angle and a second angle with respect to a plane normal to the longitudinal axis; the first angle being 45 degrees and the second angle ranging from 0 to 45 degrees.

12. The method of claim 11 wherein the mesh sleeve is mounted onto the mandrel such that the proximal end of the mesh sleeve encompasses the first part of the mandrel forming a proximal flared flange angled circumferentially at the first angle and the distal end of mesh sleeve encompasses the second part of the mandrel forming a distal flared flange angled circumferentially at the second angle.

13. The method of claim 10 wherein the step of mounting the mesh sleeve onto the mandrel further comprises the steps of:
disconnecting the first and second parts of the mandrel; the disconnecting step is performed by unscrewing the first part of the mandrel from the second part of the mandrel; and
reconnecting the first and second parts of the mandrel after mounting the mesh sleeve onto the mandrel.

14. The method of claim 1 further comprising the step of coating the proximal end of the mesh sleeve with a dispersion material; the dispersion material being made of silicone and/or urethane; wherein the coating step is performed after removing the mesh sleeve form the mandrel.

15. The method of claim 14 wherein the coating step comprises the step of dipping the proximal end of the mesh sleeve into the dispersion material or placing the proximal end of the mesh sleeve into a casting dish and pouring the dispersion material into the casting dish.

16. The method of claim 14 wherein the coating step further comprises the step of coating the proximal end of the mesh sleeve with an antimicrobial material.

Assignees

• Applied Med Resources

Inventors

• Do Alexandra
• Pravong Boun
• Wachli Serene

Classifications

• A61B17/3423 Primary

  Access ports, e.g. toroid shape introducers for instruments or hands (access sites for liquids A61M39/0247) · CPC title

• A61B2017/0287

  with elastic retracting members connectable to a frame, e.g. hooked elastic wires · CPC title

• A61B17/0218

  for minimally invasive surgery (A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence) · CPC title

• A61B17/0281 Primary

  Abdominal wall lifters · CPC title

• A61B17/0293 Primary

  with ring member to support retractor elements · CPC title