Temporary occlusion balloon devices and methods for preventing blood flow through a vascular perforation

• US 10,499,892 B2
• Filed: 03/16/2016
• Issued: 12/10/2019
• Est. Priority Date: 08/11/2015
• Status: Active Grant

• Current Assignee: Spectranetics Corporation (Koninklijke Philips N.V.)
• Original Assignee: Spectranetics Corporation (Koninklijke Philips N.V.)
• Inventors: Sotak, Ryan Michael, Foy, Grant, Aranas, Phil, Harper, Jay
• Primary Examiner(s): Tyson, Melanie R
• Application Number:
  US15/071,533
• Publication Number:
  US 20170042519A1
• Time in Patent Office: 1,364 Days
• Field of Search: 606194, 606213
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/1204 temporary occlusion
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/00597 Implements comprising a membrane
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/0065 the implement being an adhesive
• CPC Class Codes: A61B 2017/00659 located only on one side of the opening
• CPC Class Codes: A61B 2017/00676 promotion of self-sealing of the puncture
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1079 having radio-opaque markers in the region of the balloon

Abstract

A device for occluding a perforation in a blood vessel includes a catheter shaft that has a first lumen and a second lumen. The first lumen is adapted to receive at least one of a guidewire and an implanted cardiac lead, and the second lumen is adapted to receive an inflation fluid. The device further includes an inflatable balloon that is carried by the catheter shaft. The inflatable balloon is adapted to receive the inflation fluid from the second lumen. The inflatable balloon has a working length of about 65 mm to about 80 mm and an inflated diameter of about 20 mm to about 25 mm.

Claims

1. A device for occluding a perforation in a superior vena cava, the device comprising:

a catheter shaft having a first lumen and a second lumen, the first lumen being adapted to receive at least one of a guidewire and an implanted cardiac lead, and the second lumen being adapted to receive an inflation fluid, wherein the second lumen includes a cross-sectional area at a location along a length of the catheter shaft between 0.65 mm² and 1.90 mm²; and

an inflatable balloon carried by the catheter shaft and adapted to receive the inflation fluid from the second lumen, the inflatable balloon having a working length of about 65 mm to about 80 mm, and the inflatable balloon having an inflated diameter of about 20 mm to about 25 mm.

2. The device according to claim 1, wherein the inflatable balloon comprises polyurethane.

3. The device according to claim 1, wherein the inflatable balloon comprises a proximal tapered portion, a distal tapered portion, and a working portion disposed between the proximal tapered portion and the distal tapered portion, the working portion having the inflated diameter of about 20 mm to about 25 mm.

4. The device according to claim 1, wherein the first lumen and the second lumen are non-concentrically disposed within the catheter shaft.

5. The device according to claim 4, wherein the cross-sectional area of the second lumen includes a crescent shape.

6. The device according to claim 5, wherein the cross-sectional area of the second lumen is about 1 mm².

7. The device according to claim 5, wherein the crescent shape provides the cross-sectional area with a crescent-like cross-sectional shape, and wherein the crescent-like cross-sectional shape has a radius of about between 0.50 mm to 1.50 mm.

8. The device according to claim 7, wherein the radius of the crescent-like cross-sectional shape is about 1 mm.

9. The device according to claim 1, further comprising at least two radiopaque markers, wherein a first radiopaque marker is carried by the catheter shaft and a second radiopaque marker is carried by the catheter shaft.

10. The device according to claim 9, wherein the at least radiopaque markers further comprise a third radiopaque marker.

11. The device according to claim 10, wherein the inflatable balloon comprises a proximal portion, a distal portion, and an intermediate portion disposed between the proximal and distal portions, wherein the first, second, and third radiopaque markers are carried within the inflatable balloon, and wherein the first radiopaque marker is axially aligned with the proximal portion, the second radiopaque marker is axially aligned with the intermediate portion, and the third radiopaque marker is axially aligned with the distal portion.

12. The device according to claim 1, further comprising an occlusion patch detachably carried by the inflatable balloon, the occlusion patch being deployable from the inflatable balloon to occlude the perforation.

13. The device according to claim 12, wherein the occlusion patch includes at least one adhesive adapted to maintain a position of the occlusion patch within the superior vena cava.

14. The device according to claim 13, wherein the at least one adhesive is adapted to be activated by application of at least one of heat, pH, and light.

15. The device according to claim 12, wherein the occlusion patch includes a scaffold structure adapted to facilitate tissue growth therein.

16. The device according to claim 12, wherein the occlusion patch includes stem cells to facilitate bioabsorption of the occlusion patch.

17. The device according to claim 12, wherein the occlusion patch includes at least one hormonal agent adapted to promote wound healing.