Everting balloon for medical devices

• US 10,188,411 B2
• Filed: 04/28/2016
• Issued: 01/29/2019
• Est. Priority Date: 04/16/2013
• Status: Active Grant

• Current Assignee: Calcula Technologies, Inc.
• Original Assignee: Calcula Technologies, Inc.
• Inventors: Bonneau, Raymond Arthur, Gal, David, Snow, David Wellman
• Primary Examiner(s): Ton, Martin T
• Application Number:
  US15/141,512
• Publication Number:
  US 20160242799A1
• Time in Patent Office: 1,006 Days
• Field of Search: 606127, 60410306, 60410307, 60410309, 60410314
• CPC Class Codes: A61B 1/005 Flexible endoscopes
• CPC Class Codes: A61B 1/05 characterised by the image sensor, e.g. camera, being in the distal end portion
• CPC Class Codes: A61B 17/22032 having inflatable gripping elements balloon catheters A61M25/10
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/22061 for spreading elements apart
• CPC Class Codes: A61B 2017/22068 Centering
• CPC Class Codes: A61B 2017/2212 having a closed distal end, e.g. a loop
• CPC Class Codes: A61B 2017/2215 having an open distal end
• CPC Class Codes: A61B 2017/320064 with tissue or sample retaining means
• CPC Class Codes: A61B 2090/3614 using optical fibre
• CPC Class Codes: A61B 90/37 Surgical systems with images on a monitor during operation
• CPC Class Codes: A61M 2025/109 having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow
• CPC Class Codes: A61M 25/1034 Joining of shaft and balloon

Abstract

A device for removing an obstruction from a lumen in a human or animal subject may include an inflatable balloon. The inflatable balloon may include a proximal tapered portion having a proximal taper angle, a central portion, and a distal tapered portion having a distal taper angle that is greater than the proximal taper angle. The balloon may also include at least one eversion feature on the proximal tapered portion and/or the distal tapered portion. The eversion feature may facilitate preferential eversion of the distal tapered portion into an inside of the balloon without the proximal tapered portion collapsing. Preferential eversion of the distal tapered portion may be provided by the differences in the distal and proximal taper angles and by one or more of a number of different types of eversion features.

Claims

1. A device for removing a kidney stone from a urinary tract in a human or animal subject, the device comprising:

a handle;

a retention member slider coupled with the handle;

an elongate, flexible, outer shaft having a distal end and a proximal end, wherein the outer shaft defines a longitudinal axis extending between the distal and proximal ends;

a lumen wall protection member shaft coaxially disposed within the outer shaft;

an inflatable balloon, comprising;

a proximal attachment portion coupled with the distal end of the outer shaft;

a proximal tapered portion immediately adjacent the proximal attachment portion, having a first longitudinal length, measured along the longitudinal axis;

a central cylindrical portion immediately adjacent the proximal tapered portion, having a second longitudinal length, measured along the longitudinal axis;

a distal tapered portion immediately adjacent the central cylindrical portion, having a third longitudinal length, measured along the longitudinal axis; and

a distal attachment portion immediately adjacent the distal tapered portion, coupled with a distal end of the lumen wall protection member shaft,

wherein the second longitudinal length is longer than the first longitudinal length, and the first longitudinal length is longer than the third longitudinal length;

at least one eversion feature configured to facilitate preferential eversion of the distal tapered portion of the inflatable balloon into an inside of the balloon, rather than the proximal tapered portion, wherein the at least one eversion feature comprises a greater thickness of material on the proximal tapered portion as compared to the distal tapered portion; and

an expandable obstruction retention member extending coaxially within the lumen wall protection member shaft and attached proximally to the retention member slider.

2. A device as in claim 1, wherein the distal tapered portion has a taper angle of between 30 degrees and 90 degrees.

3. A device as in claim 2, wherein the proximal tapered portion has a taper angle of between 5 degrees and 25 degrees.

4. A device as in claim 1, wherein the at least one eversion feature further comprises a higher durometer material on the proximal tapered portion as compared to the distal tapered portion.

5. A device as in claim 1, wherein the at least one eversion feature further comprises at least one extra layer of material on the proximal tapered portion as compared to the distal tapered portion.

6. A device as in claim 1, wherein the at least one eversion feature further comprises multiple support ribs on the proximal tapered portion.

7. A device as in claim 1, wherein the at least one eversion feature further comprises multiple surface features on the outer shaft at a location where the proximal attachment portion of the balloon is attached to the outer shaft.

8. A device as in claim 1, wherein the at least one eversion feature further comprises multiple surface features on the lumen wall protection member shaft at a location where the distal attachment portion of the balloon is attached to the lumen wall protection member shaft.

9. A device as in claim 1, wherein the balloon is configured to automatically deflate at least partially, and the distal tapered portion is configured to automatically evert into the inside of the balloon, when the kidney stone is pulled into the distal tapered portion or the balloon is advanced over the kidney stone.

10. A device as in claim 1, wherein a space between the outer shaft and the lumen wall protection member shaft comprises an inflation lumen in fluid communication with the inflatable balloon.

11. A device as in claim 1, wherein the lumen wall protection member shaft is movable along the longitudinal axis relative to the outer shaft, and wherein sliding the lumen wall protection member shaft proximally relative to the outer shaft causes the distal tapered portion to evert into the balloon.

12. A device as in claim 1, wherein the obstruction retention member comprises:

a retention member shaft having a proximal end fixedly attached to the retention member slider, such that when the retention member slider slides back and forth along the handle, the retention member shaft slides with the retention member slider; and

an expandable basket disposed at a distal end of the retention member shaft.

13. A device as in claim 12, further comprising an elongate, flexible, inner shaft extending coaxially within at least part of the lumen wall protection member shaft, wherein the obstruction retention member is disposed coaxially within the inner shaft.

14. A device as in claim 13, further comprising an elongate, flexible camera positioned coaxially within a lumen of the retention member shaft, wherein a proximal end of the camera is fixedly attached to the handle, such that the camera does not move relative to the handle and the inner shaft, and such that a distal end of the camera is located at or near a distal end of the inner shaft, wherein the retention member shaft slides back and forth between the inner shaft and the camera.