Coated sling material

• US 7,025,063 B2
• Filed: 08/24/2001
• Issued: 04/11/2006
• Est. Priority Date: 09/07/2000
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Ams Research Corporation (Endo International PLC)
• Inventors: Snitkin, Eva S., Cabak, James E., Westrum, John W. Jr.
• Primary Examiner(s): Lo, Weilun
• Assistant Examiner(s): ANDERSON, CATHARINE L
• Application Number:
  US09/939,098
• Publication Number:
  US 20020072694A1
• Time in Patent Office: 1,691 Days
• Field of Search: 604329-331, 600 29- 31, 600/37, 128/885, 128/886
• US Class Current: 128/885
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/04 for suturing wounds; Holders or packages for needles or suture materials suture materials A61L17/00
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61F 2/0045 Support slings
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2250/0059 temporary
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: C08L 83/04 Polysiloxanes
• CPC Class Codes: D04B 21/12 characterised by thread material
• CPC Class Codes: D10B 2509/08 Hernia repair mesh

Abstract

The present invention relates to a sling, methods of making and using a sling, and kits comprising a sling for treating urinary incontinence. The sling has multiple elongation properties that serve to improve the support of the urethra. The sling may comprise a coated material adapted for urethral suspension. The coated sling has properties that appear to enhance the sling elongation characteristics. The coated sling further includes properties that reduce its susceptibility to bacterial infections. The sling further includes properties to enhance the proper tensioning of the sling.

Claims

1. A sling for insertion into a patient comprising:

a surgical sling adapted to support the urethra in its normal anatomic position and to prevent abnormal urethral descent under intraabdominal pressure;

said surgical sling comprising a length of material having a longitudinal axis, and a latitudinal axis;

wherein said material has a first elongation property along said longitudinal axis, and a second elongation property along said latitudinal axis,

said first and second elongation property being different from each other, and

wherein said second elongation property is greater than said first elongation property.

2. A sling for insertion into a patient comprising;

a surgical sting adapted to support the urethra in its normal anatomic position and to prevent abnormal urethral descent under intraabdominal pressure;

said surgical sling comprising a length of material having a longitudinal axis, and a latitudinal axis;

wherein said material has a first elongation property along said longitudinal axis, and a second elongation property along said latitudinal axis,

said first and second elongation property being different from each other, and

wherein said first elongation property is approximately 8% elongation beyond a normal state of said sling material when said sling material is subjected to a tension of approximately 5 lbs.

3. The sling as set forth in claim 2, wherein said second elongation property is approximately 36% elongation beyond a normal state of said sling material when said sling material is subjected to a tension of approximately 5 lbs.

4. A sling for insertion into a patient comprising:

a surgical sling adapted to support the urethra in its normal anatomic position and to prevent abnormal urethral descent under intraabdominal pressure;

said surgical sling comprising a length of material having a longitudinal axis, and a latitudinal axis;

wherein said material has a first elongation property along said longitudinal axis, and a second elongation property along said latitudinal axis,

said first and second elongation property being different from each other, and

wherein said first elongation property is in the range of approximately 24%-28% elongation beyond a normal state of said sling material when said sling is subjected to a tension of approximately 20 lbs.

5. The sling as set forth in claim 4 wherein said second elongation property is in the range of approximately 65%-75% elongation beyond a normal state of said sling material when said sling is subjected to a tension of approximately 20 lbs.

6. A sling for insertion into a patient comprising:

a surgical sling adapted to be implanted in a tension free rest position to support the urethra;

said surgical sling material comprising a length of polypropylene material having pores for promoting tissue ingrowth, a pair of major surface, a pair of ends and a pair of edges, and a longitudinal axis;

wherein said polypropylene material has a central region with at least one major surface coated with silicone, the silicone coated central region being adapted to be placed adjacent the urethra to avoid tissue erosion, and end regions without silicone coating; and

wherein said silicone coated polypropylene in the central region has a thickness within the range of approximately 0.024″

(0.61 mm) to 0.036″

(0.914 mm).

16. A sling according to claim 6 wherein the pores of the polypropylene material in the central region remain open and clear of silicone.

17. A sling according to claim 6 wherein said polypropylene comprises non-knitted polypropylene fibers.

18. A sling according to claim 17 wherein said non-knitted polypropylene fibers are multidirectional.

7. A sling for insertion into a patient comprising:

a surgical sling adapted to support the urethra in its normal anatomic position and to prevent abnormal urethral descent under intraabdominal pressure;

said surgical sling comprising a length of material having a longitudinal axis, and a latitudinal axis;

wherein said material has a first elongation property along said longitudinal axis, and a second elongation property along said latitudinal axis,

said first and second elongation property being different from each other,

said material is coated with a substance that enhances biocompatibility, and

wherein said first elongation property is in the range of approximately 19.5-21.5% elongation beyond a normal state of said sling material when said sling material is subject to a tension of approximately 20 lbs.

8. The sling as set forth in claim 7 wherein said second elongation property is in the range of approximately 120-130% elongation beyond a normal state of said sling material when said sling material is subject to a tension of approximately 20 lbs.

9. A sling for insertion into a patient comprising:

a surgical sling adapted to support the urethra in its normal anatomic position and to prevent abnormal urethral descent under intraabdominal pressure;

said surgical sling comprising a length of material having a longitudinal axis, and a latitudinal axis;

wherein said material has a first elongation property along said longitudinal axis, and a second elongation property along said latitudinal axis,

said first and second elongation property being different from each other,

said material is coated with a substance that enhances biocompatibility, and

wherein said first elongation property is approximately 2.5% elongation beyond a normal state of said sling material when said sling material is subject to a tension of approximately 5 lbs.

10. A sling for insertion into a patient comprising:

a surgical sling adapted to support the urethra in its normal anatomic position and to prevent abnormal urethral descent under intraabdominal pressure;

said surgical sling comprising a length of material having a longitudinal axis, and a latitudinal axis;

wherein said material has a first elongation property along said longitudinal axis, and a second elongation property along said latitudinal axis,

said first and second elongation property being different from each other,

said material is coated with a substance that enhances biocompatibility, and

wherein said second elongation property is approximately 65% elongation beyond a normal state of said sling material when said sling material is subject to a tension of approximately 5 lbs.

11. A sling for insertion into a patient comprising:

a surgical sling adapted to support the urethra in its normal anatomic position and to prevent abnormal urethral descent under intraabdominal pressure;

said surgical sling comprising a length of material having a longitudinal axis, and a latitudinal axis,

wherein said material has a first elongation property along said longitudinal axis, and a second elongation property along said latitudinal axis,

said first and second elongation property being different from each other,

said material is coated with a substance that enhances biocompatibility, and

wherein said first elongation property is approximately 10.5% elongation beyond a normal state of said sling material when said sling material is subject to a tension of approximately 5 lbs.

12. A sling for insertion into a patient comprising:

a surgical sling adapted to support the urethra in its normal anatomic position and to prevent abnormal urethral descent under intraabdominal pressure;

said surgical sling comprising a length of material having a longitudinal axis, and a latitudinal axis;

wherein said material has a tint elongation property along said longitudinal axis, and a second elongation property along said latitudinal axis,

said first and second elongation property being different from each other,

said material is coated with a substance that enhances biocompatibility; and

wherein said second elongation property is approximately 25% elongation beyond a normal state of said sling material when said sling material is subject to a tension of approximately 5 lbs.

13. A sling for insertion into a patient comprising:

a surgical sling adapted to support the urethra in its normal anatomic position and to prevent abnormal urethral descent under intraabdominal pressure;

said surgical sling comprising a length of material having a longitudinal axis, and a latitudinal axis;

wherein said sling comprises a plurality of regions along its longitudinal axis and wherein each region contain differing elongation properties from an immediately adjacent region, and

wherein said sling material has a coated central region having an increased longitudinal elongation property and a somewhat decreased latitudinal elongation property as compared to elongation properties of said central region in a normal state.

14. A sling as set forth in claim 13, wherein said sling material has a coated intermediate region on either side of said central region, each of said intermediate regions having a decreased longitudinal elongation property and an increased latitudinal elongation property as compared to elongation properties of each of said intermediate regions in a normal state.

15. A sling as set forth in claim 14, wherein said sling material has a coated end region adjacent each intermediate region, each of said end regions having a decreased longitudinal elongation property and an increased latitudinal elongation property as compared to elongation properties of each of said end regions in a normal state.