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

• US 10,449,336 B2
• Filed: 03/30/2017
• Issued: 10/22/2019
• 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: Foy, Grant, Harper, Jay
• Primary Examiner(s): Tyson, Melanie R
• Application Number:
  US15/474,455
• Publication Number:
  US 20170203082A1
• Time in Patent Office: 936 Days
• 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 17/12036 partial occlusion
• CPC Class Codes: A61B 17/1204 temporary occlusion
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/1214 Coils or wires
• CPC Class Codes: A61B 17/12186 liquid materials adapted to be injected
• CPC Class Codes: A61B 17/1219 expandable in contact with liquids
• CPC Class Codes: A61B 17/12195 comprising a curable material
• CPC Class Codes: A61B 2017/00495 for two-component glue
• CPC Class Codes: A61B 2017/005 hardenable using external energy source, e.g. laser, ultrasound
• 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 2017/00884 enhancing wound closure
• CPC Class Codes: A61B 2017/00898 expandable upon contact with fluid
• CPC Class Codes: A61B 2017/00942 hydrophilic
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 2090/037 with a frangible part, e.g. by reduced diameter
• 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 2025/1059 : having different inflatable sections mainly depending on the response to the inflation pressure, e.g. due to different material properties
• CPC Class Codes: A61M 25/0097 : characterised by the hub connectors A61M39/10
• CPC Class Codes: A61M 25/1002 : characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1011 : Multiple balloon catheters

Abstract

A device for occluding a perforation in a blood vessel includes an expandable member. The expandable member includes a central expandable balloon disposed between a proximal and a distal balloon, wherein the proximal and distal balloons each contain first and second compositions, respectively. The proximal, central and distal balloons have respective stiffnesses, and the central balloon has a third stiffness that is less than the first and second stiffnesses. Upon expansion, the central balloon causes the proximal balloon and the distal balloon to substantially simultaneously release the first and second compositions, thereby allowing the first composition and the second composition to combine in-situ and form, therein, a biocompatible foam to occlude a perforation within the vasculature.

Claims

1. An expandable member for occluding a perforation in a blood vessel, the expandable member comprising:

a first balloon having a first stiffness and containing a first composition;

a second balloon having a second stiffness and containing a second composition; and

a third balloon having a third stiffness, the third balloon being disposed between the first balloon and the second balloon, wherein the third stiffness is less than the first stiffness and the second stiffness, and whereupon expanding the third balloon causes the first balloon and the second balloon to release substantially simultaneously the first composition and the second composition to allow combining of the first composition and the second composition to form in-situ a biocompatible foam.

2. The expandable member of claim 1, the first balloon and the second balloon each having a pressure strength at burst less than that of the third balloon, whereupon expanding the third balloon causes the first balloon and the second balloon to break and release substantially simultaneously the first composition and the second composition.

3. The expandable member of claim 1, the first balloon further comprising a first plurality of micropores and the second balloon further comprising a second plurality of micropores whereupon expanding the third balloon causes the first balloon and the second balloon to expand and release substantially simultaneously the first composition through the first plurality of micropores and the second composition through the second plurality of micropores.

4. The expandable member of claim 1, the expandable member further comprising a longitudinal axis, wherein the first balloon, the second balloon, and the third balloon are longitudinally offset relative to one another.

5. The expandable member of claim 1, wherein the first composition and the second composition are polymeric.

6. The expandable member of claim 1, wherein the first composition is polymeric and the second composition is aqueous.

7. The expandable member of claim 1, the third balloon further having an outer surface, wherein the outer surface is coated with a third composition, and wherein the third composition is combinable with one of the first composition, the second composition, or both to form in-situ the biocompatible foam.

8. The expandable member of claim 5, further comprising a catheter shaft wherein the first balloon, the second balloon, and the third balloon are carried by the catheter shaft.

9. The expandable member of claim 5, further comprising a sheath having an inner lumen, wherein at least one of the first balloon, the second balloon, and the third balloon is moveable longitudinally within the inner lumen.

10. The expandable member of claim 1, wherein the first balloon comprises a plurality of first sub-balloons containing the first composition and the second balloon comprises a plurality of second sub-balloons containing the second composition.

11. The expandable member of claim 1 further comprising a fourth balloon enveloping the first balloon, the second balloon, and the third balloon, wherein the fourth balloon is configured to break prior to the first balloon releasing the first composition and the second balloon releasing the second composition.

12. The expandable member of claim 1, wherein the biocompatible foam forms an occlusion patch.