Cuff-resistant anchoring balloon for medical device

Patent metadata

Field	Value
Publication number	US-9480824-B2
Application number	US-201314139609-A
Country	US
Kind code	B2
Filing date	Dec 23, 2013
Priority date	Dec 23, 2013
Publication date	Nov 1, 2016
Grant date	Nov 1, 2016

Abstract

A medical device having an elongate support structure and an inflatable balloon including a first-end portion secured to the support structure at a first location, a second-end portion secured to the support structure at a second location distal to the first location, and a middle-body portion. The first-end portion has a wall thickness greater than a wall thickness of the middle-body portion; the balloon defines a sealed interior through which the support structure extends. The balloon being stretch-mounted to the support structure in tension relative to the support structure; the balloon is formed in a diamond-like configuration that transitions to a substantially spherical configuration when the balloon is inflated to a inflation pressure that is at least about ten percent greater than atmospheric pressure, such that when inflated to the inflation pressure and anchored in an anatomical body region, resists movement of the support structure relative to the balloon.

First claim

What is claimed is:

1. A medical device, comprising:
an elongate support structure; and
an inflatable balloon, the balloon comprising a first-end portion secured to the support structure at a first location, a second-end portion secured to the support structure at a second location distal to the first location, and a middle-body portion,
the middle-body portion having a first end integrally formed with or otherwise bonded to the first-end portion, and a second end integrally formed with or otherwise bonded to the second-end portion,
the first-end portion having a wall thickness greater than a wall thickness of the middle-body portion,
the respective first-end portion, middle-body portion and second-end portion collectively defining a sealed interior of the balloon through which the support structure extends,
the balloon being stretch-mounted to the support structure so as to be in tension relative to the support structure,
wherein the balloon is formed in a diamond shaped configuration that transitions to a substantially spherical configuration when the balloon is inflated to an inflation pressure that is at least about ten percent greater than atmospheric pressure external to the balloon,
such that the balloon, when inflated to the inflation pressure and anchored in an anatomical body region, resists movement of the support structure relative to the balloon.

2. The medical device of claim 1 , wherein the balloon middle-body portion is twisted relative to the support structure.

3. The medical device of claim 1 , wherein the support structure comprises a plurality of elongate members, and wherein the first-end portion of the balloon is secured to a first elongate member of the support structure, and the second-end portion of the balloon is secured to a second elongate member of the support structure.

4. The medical device of claim 1 , wherein the first-end portion and second-end portion of the balloon are each secured to the support structure by one of adhesive bonding, thermal bonding, interlocking geometries, and mechanical fastening.

5. The medical device of claim 1 , wherein the balloon comprises one or more polymeric materials.

6. The medical device of claim 5 , wherein the balloon comprises a shore durometer in a range of between about A90 to about A100.

7. The medical device of claim 5 , wherein the balloon comprises a shore durometer in a range of between about D30 to about D70.

8. The medical device of claim 1 , wherein the balloon, when inflated to the inflation pressure, resists cuffing relative to the support structure.

9. The medical device of claim 1 , wherein the inflation pressure is at least about 12 percent greater than the atmospheric pressure.

10. The medical device of claim 1 , wherein the balloon middle-body portion has a non-tensioned length, and wherein the balloon middle-body portion is stretched to a tensioned length that is in a range of about 8% to about 12% greater than the non-tensioned length.

11. A method of manufacturing a medical device, comprising:
forming an inflatable balloon having a first-end portion, a second-end portion, and a middle-body portion, the middle-body portion having a first end integrally formed with or otherwise bonded to the first-end portion, and a second end integrally formed with or otherwise bonded to the second-end portion, the first-end portion having a wall thickness greater than a wall thickness of the middle-body portion;
securing the first-end portion of the balloon to a first location on an elongate support structure; and
securing the second-end portion of the balloon to a second location distal to the first location on the elongate support structure, the first and second locations being spaced apart such that the balloon is stretch-mounted to the support structure so as to be in tension relative to the support structure, the first-end portion, middle-body portion and second-end portion of the balloon collectively define a sealed interior of the balloon through which the support structure extends,
wherein the balloon is formed in a diamond shaped configuration that transitions to a substantially spherical configuration when the balloon is inflated to an inflation pressure that is at least about ten percent greater than atmospheric pressure external to the balloon.

12. The method of claim 11 , wherein the middle-body portion of the balloon is twisted relative to the support structure prior to securing the second-end portion of the balloon to the support structure.

13. The method of claim 11 , wherein the support structure comprises a plurality of elongate members, and wherein the first-end portion of the balloon is secured to a first elongate member of the support structure, and the second-end portion of the balloon is secured to a second elongate member of the support structure.

14. The method of claim 11 , wherein the first-end portion and second-end portion of the balloon are each secured to the support structure by one of adhesive bonding, thermal bonding, interlocking geometries, and mechanical fastening.

15. The method of claim 11 , wherein the balloon comprises one or more polymeric materials.

16. The method of claim 15 , wherein the balloon comprises a shore durometer in a range of between about A90 to about A100.

17. The method of claim 15 , wherein the balloon comprises a shore durometer in a range of between about D30 to about D70.

18. The method of claim 11 , wherein the balloon middle-body portion has a non-tensioned length, and wherein the balloon middle-body portion is stretched to a tensioned length that is in a range of about 8% to about 12% greater than the non-tensioned length.

Assignees

• Hologic Inc

Inventors

• Kaiser Christopher Charles
• Schenck Jessica Tina

Classifications

• A61M25/1027

  Making of balloon catheters · CPC title

• A61M2025/1059

  having different inflatable sections mainly depending on the response to the inflation pressure, e.g. due to different material properties · CPC title

• A61M25/1029

  Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril · CPC title

• A61M2025/1068

  having means for varying the length or diameter of the deployed balloon, this variations could be caused by excess pressure · CPC title

• A61M25/10 Primary

  Balloon catheters ({A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02;} inflatable balloons for placing stents or stent-grafts A61F2/958 {; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00}) · CPC title