Tissue adhesive coatings for drug coated balloon

Patent metadata

Field	Value
Publication number	US-9782516-B2
Application number	US-201313842445-A
Country	US
Kind code	B2
Filing date	Mar 15, 2013
Priority date	Mar 15, 2013
Publication date	Oct 10, 2017
Grant date	Oct 10, 2017

Abstract

A therapeutic formulation is described for a drug delivery balloon comprising a therapeutic formulation which includes a therapeutic agent and an adhesion additive. The adhesion additive promotes adhesion of the therapeutic formulation a vessel wall of a subject. A system and a method of manufacturing a system including an expandable member having a working length with the therapeutic formulation disposed along at least a portion of the working length is also provided.

First claim

The invention claimed is:

1. A system for delivering a therapeutic agent to a vessel wall of a subject, comprising:
a polymeric balloon having a distal end, a proximal end, and a working length therebetween; and
a therapeutic formulation coating disposed on at least a portion of the working length of the balloon, the therapeutic formulation coating consisting essentially of a mixture of a therapeutic agent and a synthetic polycationic polymer, wherein the therapeutic agent is a cytostatic agent and the synthetic polycationic polymer promotes fibrin formation on the vessel wall to promote adhesion of the therapeutic formulation coating to the vessel wall, wherein the synthetic polycationic polymer is selected from the group consisting of polyethyleneimine, polyallylamine, poly(L-lysine), poly(D-lysine), poly(L-arginine), poly(D-arginine), poly(L-histidine), poly(D-histidine), and combinations thereof.

2. The system of claim 1 , wherein the therapeutic agent is zotarolimus, and the synthetic polycationic polymer is polyethyleneimine.

3. The system of claim 2 , wherein the ratio of zotarolimus:polyethyleneimine is about 1:1 by weight.

4. The system of claim 1 , wherein the therapeutic agent is zotarolimus, and the synthetic polycationic polymer is poly(L-lysine).

5. The system of claim 4 , wherein the ratio of zotarolimus:poly(L-lysine) is about 1:1 by weight.

6. The system of claim 1 , wherein the therapeutic agent is selected from the group consisting of zotarolimus, sirolimus, rapamycin, everolimus, biolimus, myolimus, novolimus, temsirolimus, deforolimus, merilimus, sirolimus derivatives, tacrolimus, pimecrolimus, derivatives and analogues thereof, and combinations thereof.

7. The system of claim 1 , wherein the cytostatic agent is crystalline.

8. The system of claim 1 , further comprising a prosthesis mounted on the balloon.

9. The system of claim 8 , wherein the prosthesis is a stent.

10. A method for manufacturing a system for delivering a therapeutic agent to a vessel wall of a subject, comprising:
(a) providing a system comprising a polymeric balloon having a distal end, a proximal end, and a working length therebetween; and
(b) disposing a therapeutic formulation coating on at least a portion of the working length of the balloon, wherein the therapeutic formulation coating consists essentially of a mixture of a therapeutic agent and a synthetic polycationic polymer;
wherein the therapeutic agent is a cytostatic agent and the synthetic polycationic polymer promotes fibrin formation on the vessel wall to promote adhesion of the therapeutic formulation coating to the vessel wall, wherein the synthetic polycationic polymer is selected from the group consisting of polyethyleneimine, polyallylamine, poly(L-lysine), poly(D-lysine), poly(L-arginine), poly(D-arginine), poly(L-histidine), poly(D-histidine), and combinations thereof.

Assignees

• Abbott Cardiovascular Systems Inc

Inventors

• Pacetti Stephen D
• Stankus John

Classifications

• A61L2430/34

  for soft tissue reconstruction · CPC title

• A61L27/3695 Primary

  characterised by the function or physical properties of the final product, where no specific conditions are defined to achieve this (A61L27/3687, A61L27/3691 take precedence) · CPC title

• A61L31/16

  Biologically active materials, e.g. therapeutic substances {(A61L31/047 takes precedence)} · CPC title

• A61L27/3604

  characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel · CPC title

• A61L2400/06

  Flowable or injectable implant compositions · CPC title