Application of a therapeutic substance to a tissue location using a porous medical device

• US 20050113687A1
• Filed: 09/15/2004
• Published: 05/26/2005
• Est. Priority Date: 09/15/2003
• Status: Abandoned Application

• Current Assignee: Atrium Medical Corporation (Getinge AB)
• Original Assignee: Atrium Medical Corporation (Getinge AB)
• Inventors: Martakos, Paul, Labrecque, Roger, Karwoski, Theodore, Herweck, Steve A., Carlton, Trevor, Moodie, Geoffrey
• Application Number:
  US10/943,075
• Publication Number:
  US 20050113687A1
• Time in Patent Office: Days
• US Class Current: 600/435
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• 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 2025/1088 having special surface characteristics depending on material properties or added substances, e.g. for reducing friction
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1027 Making of balloon catheters
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A non-polymeric or biological coating applied to porous radially expandable interventional medical devices provides uniform drug distribution and permeation of the coating and any therapeutic agents mixed therewith into a targeted treatment area within the body. The coating is sterile, and is capable of being carried by a sterile medical device to a targeted tissue location within the body following radial expansion. The therapeutic coating transfers off the medical device due in part to a biological attraction with the tissue and in part to a physical transference from the medical device to the targeted tissue location in contact with the medical device. Thus, atraumatic local tissue transference delivery is achieved for uniform therapeutic agent distribution and controlled bio-absorption into the tissue after placement within a patient'"'"'s body with a non-inflammatory coating.

Claims

1. A radially expandable medical device, comprising:

a body having an interior and a porous exterior surface; and

a therapeutic coating disposed on at least a portion of the exterior surface of the body upon expansion of the radially expandable medical device;

wherein at least a portion of the therapeutic coating passes from the interior of the body to the exterior surface of the body to at least partially form the therapeutic coating; and

wherein the therapeutic coating is compositioned to transfer and adhere to a targeted tissue location to create an atraumatic therapeutic effect.

2. The radially expandable medical device of claim 1, wherein the therapeutic coating comprises fatty acids including omega-3 fatty acids.

3. The radially expandable medical device of claim 1, wherein a therapeutic agent is emulsified in the therapeutic coating.

4. The radially expandable medical device of claim 1, wherein a therapeutic agent is suspended in the therapeutic coating.

5. The radially expandable medical device of claim 1, wherein the therapeutic coating is at least partially hydrogenated.

6. The radially expandable medical device of claim 1, wherein the therapeutic coating further comprises at least one of a non-polymeric substance, a binder, and a viscosity increasing agent to stabilize the therapeutic mixture.

7. The radially expandable medical device of claim 1, wherein upon implantation, the therapeutic coating maintains one of a soft solid, gel, and viscous liquid consistency.

8. The radially expandable medical device of claim 1, wherein the therapeutic coating further comprises a solvent.

9. The radially expandable medical device of claim 1, wherein the medical device comprises at least one of an endovascular prosthesis, an intraluminal prosthesis, a shunt, a catheter, a surgical tool, a suture wire, a stent, and a local drug delivery device.

10. A method of applying a therapeutic coating to a targeted tissue location, comprising:

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

providing a therapeutic liquid to a radially expandable medical device to expand the radially expandable medical device;

at least one of forming and re-supplying the therapeutic coating on at least a portion of an exterior surface of the radially expandable medical device; and

smearing the therapeutic coating against the targeted tissue location, thus transferring at least a portion of the therapeutic coating to adhere to the targeted tissue location.

11. The method of claim 10, further comprising removing the medical device.

12. The method of claim 10, further comprising leaving the medical device as an implant at the targeted tissue location.

13. The method of claim 10, wherein the therapeutic coating comprises fatty acids including omega-3 fatty acids.

14. The method of claim 10, wherein a therapeutic agent is emulsified in the therapeutic coating.

15. The method of claim 10, wherein a therapeutic agent is suspended in the therapeutic coating.

16. The method of claim 10, wherein the therapeutic coating is at least partially hydrogenated.

17. The method of claim 10, wherein the therapeutic coating further comprises at least one of a non-polymeric substance, a binder, and a viscosity increasing agent to stabilize the therapeutic mixture.

18. The method of claim 10, wherein upon implantation, the therapeutic coating maintains one of a soft solid, gel, and viscous liquid consistency.

19. The method of claim 10, wherein the therapeutic coating further comprises a solvent.

20. The method of claim 10, wherein the radially expandable medical device comprises at least one of an endovascular prosthesis, an intraluminal prosthesis, a shunt, a catheter, a surgical tool, a stent, and a local drug delivery device.

21. The method of claim 10, wherein a plurality of radially expandable medical devices are utilized during a procedure to apply the therapeutic coating.

22. A method of applying a first therapeutic coating, a second therapeutic coating, and a third therapeutic coating to a targeted tissue location within a patient, comprising:

providing a first medical device;

positioning the first medical device in proximity with the targeted tissue location;

radially expanding the first medical device against the targeted tissue location using a first therapeutic liquid to pressurize the first medical device;

forming the first therapeutic coating by weeping the first therapeutic liquid through a wall of the first medical device;

smearing the first therapeutic coating against the targeted tissue location;

deflating and removing the first medical device;

providing a second medical device with the second therapeutic coating, wherein the second medical device includes a balloon portion and a stent portion;

radially expanding the second medical device against the targeted tissue location using a second therapeutic liquid to pressurize the second medical device;

forming the second therapeutic coating by weeping the second therapeutic liquid through a wall of the second medical device;

smearing the second therapeutic coating against the targeted tissue location;

deflating and removing the balloon portion of the second medical device;

providing a third medical device with the third therapeutic coating;

positioning the third medical device in proximity with the targeted tissue location;

radially expanding the third medical device against the targeted tissue location using a third therapeutic liquid to pressurize the third medical device;

forming the third therapeutic coating by weeping the third therapeutic liquid through a wall of the third medical device;

smearing the third therapeutic coating against the targeted tissue location; and

.

deflating and removing the third medical device.

23. A porous balloon catheter, comprising:

a body having an exterior surface; and

a therapeutic coating disposed on at least a portion of the exterior surface;

wherein the therapeutic coating is compositioned to adhere to the exterior surface of the balloon catheter while the balloon catheter is positioned proximal to a targeted tissue location within a patient, and then transfer to the targeted tissue location upon contact between the therapeutic coating and the targeted tissue location at the time of radial expansion to create an atraumatic therapeutic effect.

24. The porous balloon catheter of claim 23, wherein the balloon catheter comprises a PTFE balloon catheter.

25. A method of applying a therapeutic coating to a targeted tissue location, comprising:

positioning a porous balloon catheter proximal to a targeted tissue location within a patient in a first interventional procedure;

weeping a therapeutic fluid through walls of the porous balloon catheter to form a therapeutic coating on the porous balloon catheter;

smearing the therapeutic coating against the targeted tissue location, thus transferring at least a portion of the therapeutic coating to adhere to the targeted tissue location during expansion of the porous balloon catheter; and

removing the porous balloon catheter from the patient.

26. The method of claim 25, further comprising:

positioning a second porous balloon catheter the stent proximal to the targeted tissue location within the patient in a second interventional procedure;

weeping a therapeutic fluid through walls of the second porous balloon catheter to form a therapeutic coating on the second porous balloon catheter;

smearing the therapeutic coating against the targeted tissue location, thus transferring at least a portion of the therapeutic coating to adhere to the targeted tissue location during expansion of the second porous balloon catheter; and

removing the second porous balloon catheter from the patient, leaving the stent.

27. The method of claim 26, further comprising:

applying the therapeutic coating to a third porous balloon catheter;

positioning the third porous balloon catheter proximal to the targeted tissue location within the patient in a third interventional procedure; and

smearing the therapeutic coating against the targeted tissue location, thus transferring at least a portion of the therapeutic coating to adhere to the targeted tissue location during expansion of the third porous balloon catheter; and

removing the third porous balloon catheter from the patient.