Medical device and method of delivering the medical device

• US 10,376,351 B2
• Filed: 03/11/2014
• Issued: 08/13/2019
• Est. Priority Date: 03/13/2013
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Pereira, Peter J., Goddard, James M., Chu, Michael S. H., Flynn, Kenneth M.
• Primary Examiner(s): Dorna, Carrie R
• Application Number:
  US14/204,985
• Publication Number:
  US 20140275754A1
• Time in Patent Office: 1,981 Days
• CPC Class Codes: A61F 2/0045 Support slings
• CPC Class Codes: A61F 2230/006 Y-shaped
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: D04B 1/14 Other fabrics or articles characterised primarily by the use of particular thread materials
• CPC Class Codes: D04B 1/18 elastic threads

Abstract

The invention discloses an implant. The implant may include a first flap and a second flap. The first flap may further include a first portion, a second portion and a transition region. The first portion may be configured to be attached proximate a sacrum. The second portion may be configured to be attached to an anterior vaginal wall. The transition region lies between the first portion and the second portion. The second flap may be fabricated such that a portion of the second flap is configured to be attached to a posterior vaginal wall. The implant may be configured such that a value corresponding to a biomechanical parameter defining a biomechanical attribute of the portion of the first flap attaching to the anterior wall is different from a value of the biomechanical parameter defining the biomechanical attribute of the portion of the second flap attaching to the posterior wall.

Claims

1. An implant comprising:

a first flap formed of a first sheet of material including;

a first portion configured to be attached proximate a sacrum, the first portion defining a plurality of first pores having a first size, the first portion having a first knit pattern;

a second portion configured to be attached to an anterior vaginal wall, the second portion defining a plurality of second pores having a second size, the second size being greater than the first size, the second portion having a second knit pattern different than the first knit pattern; and

a transition region disposed between the first portion and the second portion, wherein a value corresponding to a biomechanical parameter defining a biomechanical attribute of the second portion along a first direction is different from a value of the biomechanical parameter defining the biomechanical attribute of the first portion along a second direction, the second direction being in a longitudinal direction, the first direction being transverse with respect to the longitudinal direction, the transition region having a third knit pattern different than the first knit pattern and different than the second knit pattern, at least one end portion of the transition region extends from one end portion of the first portion or one end portion of the second portion; and

a second flap formed of a second sheet of material, the second sheet of material being separate from the first sheet of material, the second flap including;

a first portion configured to be attached proximate the sacrum;

a second portion configured to be attached to a posterior vaginal wall; and

a transition region disposed between the first portion and the second portion.

2. The implant of claim 1, wherein the second portion of the second flap defines a plurality of third pores having a third size.

3. The implant of claim 1, wherein a width of the second portion of the first flap is larger than a width of the first portion of the first flap, and a width of the second portion of the second flap is larger than a width of the first portion of the second flap.

4. The implant of claim 3, wherein the second portion of the first flap includes a proximal end and a distal end, the distal end being proximate the transition region of the first flap, wherein the width of the second portion of the first flap varies from the proximal end to the distal end of the second portion of the first flap.

5. The implant of claim 4, wherein the varying width of the second portion of the first flap defines a trapezoidal shape of the second portion of the first flap.

6. The implant of claim 1, wherein the first sheet of material is mesh, and the second sheet of material is mesh.

7. The implant of claim 1, wherein the first portion of the first flap is coupled to the second portion of the first flap at the transition region of the first flap with one or more sutures, and the first portion of the second flap is coupled to the second portion of the second flap at the transition region of the second flap with one or more sutures.

8. The implant of claim 1, wherein the biomechanical attribute is elasticity and the biomechanical parameter is a modulus of elasticity.

9. The implant of claim 1, wherein the biomechanical attribute is viscoelasticity or viscohyperlasticity.

10. The implant of claim 1, wherein the first portion of the first flap defines a set of biomechanical attributes that emulate a biomechanical behavior of the sacrum, the second portion of the first flap defines a set of biomechanical attributes that emulate a biomechanical behavior of the anterior vaginal wall, the first portion of the second flap defines a set of biomechanical attributes that emulate the biomechanical behavior of the sacrum, and the second portion of the second flap defines a set of biomechanical attributes that emulate a biomechanical behavior of the posterior vaginal wall.

11. The implant of claim 1, wherein the biomechanical attribute is anisotropicity.

12. The implant of claim 1, wherein the biomechanical attribute is resistance to creep.

13. The implant of claim 1, wherein the biomechanical attribute is stiffness.

14. The implant of claim 1, wherein the first sheet of material has a weight less than 30 grams per square meter.

15. An implant, comprising:

a first sheet of mesh material having a first portion, a second portion, and a transition region disposed between the first portion and the second portion, the first portion configured to be attached proximate a sacrum, the second portion configured to be attached to an anterior vaginal wall, wherein a value corresponding to a biomechanical parameter of the first portion of the first sheet of material is different from a value of the biomechanical parameter of the second portion of the first sheet of material, the first portion of the first sheet of material having a weight that is different than the second portion of the first sheet of material, the first portion of the first sheet of material defining a plurality of first pores having a first size, the second portion of the first sheet of material defining a plurality of second pores having a second size, the second size being greater than the first size,

wherein the biomechanical parameter is stiffness, and the value of the biomechanical parameter of the second portion of the first sheet of material is within a range of 5.515-17.28 MPa in a first direction; and

a second sheet of mesh material, the second sheet of mesh material being separate from the first sheet of mesh material, the second sheet of mesh material having a first portion and a second portion, the first portion of the second sheet of mesh material configured to be attached proximate to the sacrum, the second portion of the second sheet of mesh material configured to be attached to a posterior vaginal wall;

wherein the first portion of the first sheet of material has a first type of knit pattern, the second portion of the first sheet of material has a second type of knit pattern, the transition region of the first sheet of material has a third type of knit pattern, and the second portion of the second sheet of material has a fourth type of knit pattern, wherein the first type of knit pattern, the second type of knit pattern, the third type of knit pattern, and the fourth type of knit pattern are different from each other.

16. The implant of claim 15, wherein the value of the biomechanical parameter of the second portion of the first sheet of material is within a range of 0.385-0.415 MPa in a second direction, the second direction being perpendicular to the first direction.

17. The implant of claim 15, wherein a value corresponding to a biomechanical parameter of stiffness of the first portion of the second sheet of material is different from a value of the biomechanical parameter of stiffness of the second portion of the second sheet of material.

18. The implant of claim 15, wherein one portion of the first sheet of material has a weight greater than 30 grams per square meter and another portion of the first sheet of material has a weight of less than 30 grams per square meter.

19. An implant comprising:

a first flap formed of a first sheet of material including;

a first portion configured to be attached proximate a sacrum, the first portion defining a plurality of first pores having a first size, the first portion having a first knit pattern, the first portion defines a first length along a first side extending from a proximal end portion to the distal end portion, and a second length along a second side extending from the proximal end portion to the distal portion, the first length being different than the second length;

a second portion configured to be attached to an anterior vaginal wall, the second portion defining a plurality of second pores having a second size, the second size being greater than the first size, the second portion having a second knit pattern different than the first knit pattern; and

a transition region disposed between the first portion and the second portion, wherein a value corresponding to a biomechanical parameter defining a biomechanical attribute of the second portion along a first direction is different from a value of the biomechanical parameter defining the biomechanical attribute of the first portion along a second direction, the second direction being in a longitudinal direction, the first direction being transverse with respect to the longitudinal direction, the transition region having a third knit pattern different than the first knit pattern and different than the second knit pattern; and

a second flap formed of a second sheet of material, the second sheet of material being separate from the first sheet of material, the second flap including;

a first portion configured to be attached proximate the sacrum;

a second portion configured to be attached to a posterior vaginal wall; and

a transition region disposed between the first portion and the second portion.