Application of a therapeutic substance to a tissue location using an expandable medical device

• US 7,947,015 B2
• Filed: 05/18/2007
• Issued: 05/24/2011
• Est. Priority Date: 01/25/1999
• Status: Expired due to Fees

• Current Assignee: Atrium Medical Corporation (Getinge AB)
• Original Assignee: Atrium Medical Corporation (Getinge AB)
• Inventors: Labrecque, Roger, Karwoski, Theodore, Herweck, Steve A., Carlton, Trevor, Moodie, Geoffrey, Martakos, Paul
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): CHANDER, DIVA KAKAR
• Application Number:
  US11/804,478
• Publication Number:
  US 20080015500A1
• Time in Patent Office: 1,467 Days
• Field of Search: 604/103.01, 604/103.02, 606/108
• US Class Current: 604/103.02
• CPC Class Codes: A61L 2300/22 Lipids, fatty acids, e.g. prostaglandins, oils, fats, waxes
• CPC Class Codes: A61L 2300/606 Coatings
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: A61L 29/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61M 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• CPC Class Codes: A61M 2025/1088 having special surface characteristics depending on material properties or added substances, e.g. for reducing friction
• CPC Class Codes: A61M 25/1027 Making of balloon catheters
• CPC Class Codes: C08L 27/18 Homopolymers or copolymers or tetrafluoroethene

Abstract

A non-polymeric or biological coating applied to radially expandable medical delivery device provides uniform drug distribution and permeation of the coating and any therapeutic agents mixed therewith into a targeted treatment area within the body. The delivery device is expanded using the pressure of an inflation fluid. After expanding the delivery device to a pre-determined size and shape, the inflation fluid weeps through the porous surface of the delivery device. The coating releases the delivery device and floats on the inflation fluid until bonding to the tissue due to its affinity for the tissue. Once the coating bonds or affixes to the tissue, through an absorption mechanism by the tissue cells of the coating material, the coating and any therapeutics contained therein are delivered to the tissue. The fluid can contain a therapeutic agent, or can be otherwise biocompatible and/or inert.

Claims

1. A radially expandable porous delivery device having a shaped form, comprising:

a porous body constructed of fluoropolymer material, the fluoropolymer material having a microstructure of nodes interconnected by fibrils, the nodes having an internodal distance of about 10 μ

m to about 30 μ

m and oriented to create spaces between the nodes forming channels extending from an inner surface to an outer surface of the porous delivery device through which a fluid can flow;

a non-polymeric therapeutic coating disposed on the outer surface of the porous delivery device having a dynamic affinity for the delivery device as well as a targeted tissue location, such that the coating remains on the device during positioning of the delivery device;

an inflation fluid conduit disposed in the delivery device configured to supply an inflation fluid sufficient to provide an inflation fluid force to expand the porous body from a reduced diameter collapsed configuration to a pre-defined increased diameter expanded configuration;

wherein the microstructure of nodes interconnected by fibrils has a pre-determined porosity configured in part on fluid flow characteristics of the inflation fluid to cause the inflation fluid to weep through the channels at a rate substantially independent of the inflation fluid force; and

wherein the therapeutic coating is configured to release from the porous body upon action of the inflation fluid weeping through the porous body.

2. The device of claim 1, wherein the porous body is configured to achieve the pre-defined increased diameter prior to the inflation fluid weeping through the microstructure of nodes interconnected by fibrils.

3. The device of claim 1, wherein the fluoropolymer material comprises polytetrafluoroethylene (PTFE).

4. The device of claim 1, wherein the inflation fluid weeping through the channels has therapeutic characteristics.

5. The device of claim 1, wherein the pre-determined porosity comprises a designated porosity for at least a portion of the porous body.

6. The device of claim 1, wherein the inflation fluid comprises at least one of antioxidants, anti-hypertensive agents, anti-inflammatory agents, growth factor antagonists, anti-platelet agents, anti-coagulant agents, thrombolytic agents, drugs to alter lipid metabolism, ACE inhibitors, anti-proliferatives, anti-neoplastics, tissue growth stimulants, gasses, agents for promotion of hollow organ occlusion or thrombosis, agents for functional protein or factor delivery, agents for second messenger targeting, angiogenic agents, anti-angiogenic agents, agents for inhibition of protein synthesis, anti-infective agents, agents for gene delivery, agents for local tissue perfusion, nitric oxide donating derivatives, or contrast media.

7. The device of claim 1, wherein the inflation fluid comprises an inert biocompatible substance.

8. The device of claim 1, wherein the inflation fluid comprises saline.

9. The device of claim 1, wherein weeping is achieved by the inflation fluid flowing through the microstructure of nodes interconnected by fibrils at a rate that will not injure tissue with hydraulic fluid forces.

10. The device of claim 1, wherein the porous delivery device is configured to hold the inflation fluid at a pressure of about 4 atmospheres.

11. The device of claim 1, wherein the porous delivery device is configured to hold the inflation fluid at a pressure of less than 6 atmospheres.

12. The device of claim 1, wherein the therapeutic coating comprises fatty acids including omega-3 fatty acids.

13. The device of claim 1, wherein the therapeutic agent is emulsified or suspended in the therapeutic coating.

14. The device of claim 1, wherein the therapeutic coating is at least partially hydrogenated.

15. The device of claim 1, wherein the therapeutic coating further comprises a binder or a viscosity increasing agent to stabilize the therapeutic coating.

16. The device of claim 1, wherein the therapeutic coating maintains one of a soft solid, gel, or viscous liquid consistency.

17. A method of applying a non-polymeric therapeutic coating to a targeted tissue location, comprising:

obtaining a collapsible porous delivery device, the device formed of a collapsible and inflatable structure with porous walls adapted to inflate to a pre-determined maximum size and shape upon introduction of an inflation fluid into the device;

applying the non-polymeric therapeutic coating to the delivery device, wherein the therapeutic coating has a dynamic affinity for the delivery device as well as a targeted tissue location, such that the coating remains on the device during positioning of the delivery device;

positioning the delivery device proximal to a targeted tissue location within a patient;

introducing the inflation fluid to the delivery device inflating the delivery device to the pre-determined maximum size and shape; and

weeping the inflation fluid through the porous walls of the delivery device and introducing the inflation fluid between the delivery device and the therapeutic coating, thus initiating transfer and transferring at least a substantial portion of the therapeutic coating from the delivery device to the substantial portion of the targeted tissue location;

wherein the substantial portion of the therapeutic coating contacts the targeted tissue location.

18. The method of claim 17, wherein a portion of the therapeutic coating permeates the targeted tissue location upon contact.

19. The method of claim 17, wherein the therapeutic coating comprises fatty acids including omega-3 fatty acids.

20. The method of claim 17, wherein a therapeutic agent is emulsified in the therapeutic coating.

21. The method of claim 17, wherein a therapeutic agent is suspended in the therapeutic coating.

22. The method of claim 17, wherein the therapeutic coating is at least partially hydrogenated.

23. The method of claim 17, wherein the therapeutic coating further comprises a binder or a viscosity increasing agent to stabilize the therapeutic coating.

24. The method of claim 17, wherein upon implantation, the therapeutic coating maintains one of a soft solid, gel, or viscous liquid consistency.

25. The method of claim 17, wherein the therapeutic coating further comprises a solvent.

26. The method of claim 17, wherein a plurality of medical devices are utilized during a procedure to apply the therapeutic coating.

27. The method of claim 17, wherein the inflation fluid contains a therapeutic agent.

28. The method of claim 17, wherein the inflation fluid is an inert biocompatible substance.

29. The method of claim 17, wherein the inflation fluid is saline.

30. The method of claim 17, wherein the delivery device is inflated at a pressure of about 4 atmospheres.

31. The method of claim 17, wherein the delivery device is formed of polytetrafluoroethylene (PTFE) material.