IP Library Granted Patent US 11,357,955
Granted Patent B2
US 11,357,955 · App. 13/554,176 · Granted Jun 14, 2022

Devices, systems, and related methods for delivery of fluid to tissue

Inventors: Carrie L. Herman (Minnetonka, MN); Natalie A. Borgos (Minnetonka, MN); Kari L. Cierzan (Minnetonka, MN)
Assignee: Boston Scientific Scimed, Inc.
A61M25/1011A61M37/0015A61M2025/105A61M2025/1013A61M2025/1086A61M2037/003A61M2037/0023A61M2037/0046
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Quick Facts
Patent No.
US 11,357,955
App. No.
13/554,176
Granted
Jun 14, 2022
Kind
B2
Abstract

A fluid delivery system including a first balloon and a second balloon at least partially positioned within the first balloon, wherein the second balloon has an inner surface, an outer surface, and at least one micro-needle extending outwardly from the outer surface of the second balloon. The delivery system can further include a fluid source in communication with at least one of the micro-needles of the second balloon.

Claims (32)

1. A system for delivering a therapeutic material to a target tissue of a patient, the system comprising:

a first expandable balloon including an outer surface, the outer surface configured to contact the target tissue within a pelvic region of the patient;

a second expandable balloon at least partially positioned within the first balloon and separately inflatable from the first balloon, the second balloon including an inner surface, an outer surface, and a plurality of micro-needles disposed on the outer surface of the second balloon and extending outwardly from the outer surface of the second balloon, each of the plurality of micro-needles including:

a proximal end;

a distal end; and

an inner lumen extending from the proximal end to the distal end;

a main supply tube that extends into the second balloon having a first end;

a first supply tube having a first end portion directly coupled to the first end of the main supply tube inside of the second balloon and a second end portion connected to at least one of the plurality of micro-needles; and

a second supply tube having a first end portion directly coupled to the first end of the main supply tube inside of the second balloon and a second end portion connected to at least one of the plurality of micro-needles, the first end portion of the second supply tube being disposed proximate the first end portion of the first supply tube,

wherein expansion of the second balloon is configured to cause the plurality of micro-needles to penetrate through the outer surface of the first balloon after inflation of the first balloon.

2. The system of claim 1 , wherein the outer surface of the first expandable balloon is configured to contact the target tissue within the pelvic region of the patient, the target tissue within the pelvic region being at least one of an inner surface of a bladder wall, an inner surface of a vaginal wall, an inner surface of an anal canal, an inner surface of a rectum, an inner surface of an anus, or an inner surface of a uterine wall.

3. The system of claim 1 , wherein the first balloon comprises a material thickness and wherein one of the plurality of micro-needles comprise a length that is greater than the material thickness of the first balloon.

4. The system of claim 3 , wherein the length of one of the plurality of micro-needles is at least as large as a combination of the thickness of the first balloon and a desired penetration depth into the target tissue.

5. The system of claim 1 , wherein each of the plurality of micro-needles comprises a textured outer surface.

6. The system of claim 1 , wherein at least one of the micro-needles includes a layer of material that covers an opening of the at least one micro-needle, the layer of material is biodegradable.

7. The system of claim 1 , wherein at least one of the micro-needles includes a plurality of layers of material that cover an opening of the at least one of the micro-needle.

8. The system of claim 1 , wherein a distal end portion of the second balloon is positioned within the first balloon.

9. The system of claim 1 , wherein the first balloon includes an inner surface and an outer surface, the inner surface of the first balloon being separate from the outer surface of the second balloon.

10. A system for delivering a therapeutic material to a target tissue of a patient, the system comprising:

a first expandable balloon including an outer surface, the outer surface configured to contact the target tissue within a pelvic region of the patient;

a second expandable balloon at least partially positioned within the first balloon and separately inflatable from the first balloon, the second balloon including an inner surface, an outer surface, and a plurality of micro-needles disposed on the outer surface of the second balloon and extending outwardly from the outer surface of the second balloon;

a main supply tube that extends into the second balloon having a first end;

a first supply tube directly coupled to the first end of the main supply tube inside of the second balloon and a second supply tube directly coupled to the first end of the main supply tube inside of the second balloon, each of the first supply tube and the second supply tube being connected to at least one of the plurality of micro-needles,

wherein expansion of the second balloon is configured to cause the plurality of micro-needles to penetrate through the outer surface of the first balloon after inflation of the first balloon.

11. The system of claim 10 , wherein the outer surface of the first expandable balloon is configured to contact the target tissue within the pelvic region of the patient, the target tissue within the pelvic region being at least one of an inner surface of a bladder wall, an inner surface of a vaginal wall, an inner surface of an anal canal, an inner surface of a rectum, an inner surface of an anus, or an inner surface of a uterine wall.

12. The system of claim 10 , wherein the first balloon comprises a material thickness and wherein one of the plurality of micro-needles comprise a length that is greater than the material thickness of the first balloon.

13. The system of claim 10 , wherein the length of one of the plurality of micro-needles is at least as large as a combination of the thickness of the first balloon and a desired penetration depth into the target tissue.

14. The system of claim 10 , wherein each of the plurality of micro-needles comprises a textured outer surface.

15. The system of claim 10 , wherein at least one of the micro-needles includes a layer of material that covers an opening of the at least one micro-needle, the layer of material is biodegradable.

16. The system of claim 10 , wherein at least one of the micro-needles includes a plurality of layers of material that cover an opening of the at least one of the micro-needle.

17. The system of claim 10 , wherein a distal end portion of the second balloon is positioned within the first balloon.

18. The system of claim 10 , wherein the first balloon includes an inner surface and an outer surface, the inner surface of the first balloon being separate from the outer surface of the second balloon.

Assignments (7)
RELEASE OF SECURITY INTEREST Recorded Apr 26, 2024
From: WILMINGTON TRUST, NATIONAL ASSOCIATION
To: ACTIENT PHARMACEUTICALS LLC; ASTORA WOMEN’S HEALTH HOLDINGS, LLC; ASTORA WOMEN’S HEALTH LLC; AUXILIUM PHARMACEUTICALS, LLC; AUXILIUM US HOLDINGS, LLC; BIOSPECIFICS TECHNOLOGIES CORP.; BIOSPECIFICS TECHNOLOGIES LLC; DAVA INTERNATIONAL, LLC; DAVA PHARMACEUTICALS, LLC; ENDO GENERIC HOLDINGS, INC. (FORMERLY KNOWN AS PAR PHARMACEUTICALS COMPANIES, INC.); ENDO PHARMACEUTICALS INC.; ENDO PHARMACEUTICALS SOLUTIONS INC. (FORMERLY KNOWN AS INDEVUS PHARMACEUTICALS, INC.); GENERICS BIDCO I, LLC; GENERICS INTERNATIONAL (US), INC.; PAR PHARMACEUTICAL, INC.; PAR STERILE PRODUCTS, LLC (FORMERLY KNOWN AS JHP PHARMACEUTICALS, LLC); QUARTZ SPECIALTY PHARMACEUTICALS, LLC; SLATE PHARMACEUTICALS, LLC; VINTAGE PHARMACEUTICALS, LLC
Reel/Frame 067240/0001 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 7, 2017
From: BOSTON SCIENTIFIC CORPORATION
To: BOSTON SCIENTIFIC SCIMED, INC.
Reel/Frame 043778/0167 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 7, 2017
From: ASTORA WOMEN'S HEALTH, LLC; ENDO HEALTH SOLUTIONS INC.; ASTORA WOMEN'S HEALTH HOLDINGS, LLC
To: BOSTON SCIENTIFIC CORPORATION
Reel/Frame 043777/0895 →
SECURITY INTEREST Recorded Jun 8, 2017
From: ASTORA WOMEN'S HEALTH, LLC
To: WILMINGTON TRUST, NATIONAL ASSOCIATION, AS COLLATERAL TRUSTEE
Reel/Frame 042743/0278 →
RELEASE OF SECURITY INTEREST Recorded Apr 28, 2017
From: DEUTSCHE BANK AG NEW YORK BRANCH
To: ENDO PHARMACEUTICALS, INC.; ENDO PHARMACEUTICALS SOLUTIONS, INC.; ASTORA WOMEN'S HEALTH HOLDINGS, LLC
Reel/Frame 042362/0001 →
CORRECTIVE ASSIGNMENT TO CORRECT THE CONVEYING PARTY DATA NAME PREVIOUSLY RECORDED AT REEL: 037300 FRAME: 0728. ASSIGNOR(S) HEREBY CONFIRMS THE CHANGE OF NAME. Recorded Apr 21, 2017
From: AMS RESEARCH CORPORATION
To: AMS RESEARCH, LLC
Reel/Frame 042308/0630 →
GRANT OF SECURITY INTEREST IN PATENTS Recorded Mar 20, 2014
From: ENDO PHARMACEUTICALS SOLUTIONS, INC.; ENDO PHARMACEUTICALS, INC.; AMS RESEARCH CORPORATION; AMERICAN MEDICAL SYSTEMS, INC.; LASERSCOPE
To: DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT
Reel/Frame 032491/0440 →