Methods, medical devices and kits for modifying the luminal profile of a body vessel

• US 10,512,751 B2
• Filed: 11/21/2018
• Issued: 12/24/2019
• Est. Priority Date: 10/07/2015
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Sigmon, Jr., John C., Surti, Vihar
• Primary Examiner(s): Stewart, Jason-Dennis N
• Application Number:
  US16/198,686
• Publication Number:
  US 20190083740A1
• Time in Patent Office: 398 Days
• CPC Class Codes: A61B 17/12036 partial occlusion
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12186 liquid materials adapted to be injected
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61M 2025/0018 having a plug, e.g. an inflatable plug for closing catheter lumens
• CPC Class Codes: A61M 2025/0089 Single injection needle protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• CPC Class Codes: A61M 25/0069 Tip not integral with tube
• CPC Class Codes: A61M 25/0084 being one or more injection needles
• CPC Class Codes: A61M 31/005 for contrast media

Abstract

Methods of modifying the luminal profile of a body vessel are described. An example method comprises advancing a cannula out of the distal end of a catheter disposed within the lumen of a body vessel of an animal and toward a target site on the wall of the body vessel; passing contrast dye through the cannula toward the target site; simultaneously continuing the advancing and passing until the distal end of the cannula punctures the inner layer of the wall of the body vessel at the target site; and passing a bulking agent through the cannula and into a space between connective tissue layers surrounding the vessel wall at the target site. Medical devices, medical device assemblies, and kits are also described.

Claims

1. A method of modifying the luminal profile of a body vessel at a target site, comprising:

passing a bulking agent through a cannula and into a space between connective tissue layers surrounding a wall of said body vessel at said target site, the bulking agent including a cross-linking agent;

wherein the method is performed to a sufficient degree to achieve occlusion of said body vessel.

2. The method of claim 1, wherein the bulking agent comprising a hydrogel.

3. The method of claim 2, wherein the hydrogel contains alginate.

4. The method of claim 3, wherein the hydrogel comprises between about 4% and about 30% alginate.

5. The method of claim 3, wherein the hydrogel comprises about 17.5% alginate.

6. The method of claim 1, wherein the bulking agent comprises about 17.5% alginate.

7. The method claim 1, wherein the crosslinking agent comprises a salt.

8. The method of claim 7, wherein the crosslinking agent is selected from the group consisting of MgCl2, CaCl2, SrCl2, BaCl2, Al3SO4, BaSO4, CaCO3, ferric chloride, and ferrous chloride.

9. The method of claim 7, wherein the crosslinking agent comprises SrCl2.

10. The method of claim 7, wherein the crosslinking agent has a concentration of between about 0.05 Molar and about 4.00 Molar.

11. The method of claim 7, wherein the crosslinking agent has a concentration of about 0.33 Molar.

12. The method of claim 1, wherein said body vessel comprises a vein.

13. A method of modifying the luminal profile of a body vessel at a target site, comprising:

passing a bulking agent through a cannula and into a space between connective tissue layers surrounding a wall of said body vessel at said target site, the bulking agent comprising a hydrogel containing alginate and including a cross-linking agent selected from the group consisting of MgCl2, CaCl2, SrCl2, BaCl2, Al3SO4, BaSO4, CaCO3, ferric chloride, and ferrous chloride;

wherein the method is performed to a sufficient degree to achieve occlusion of said body vessel.

14. The method of claim 13, wherein the hydrogel comprises between about 4% and about 30% alginate.

15. The method of claim 13, wherein the hydrogel comprises about 17.5% alginate.

16. The method of claim 13, wherein the bulking agent comprises about 17.5% alginate.

17. The method of claim 13, wherein said body vessel comprises a vein.