BALLOON CATHETER INCLUDING A DRUG DELIVERY SHEATH

• US 20170304595A1
• Filed: 04/25/2016
• Published: 10/26/2017
• Est. Priority Date: 04/25/2016
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Nagasrinivasa, Shyam, Silvestro, Claudio
• Granted Patent: US 10,940,294 B2
• Time in Patent Office: Days
• CPC Class Codes: A61M 2025/1031 Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface
• 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 2025/1081 having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
• 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 25/104 used for angioplasty

Abstract

A balloon catheter includes an elongated catheter shaft, an expandable balloon connected to the elongated catheter shaft, and a sheath that defines a lumen and includes a therapeutic agent disposed within the lumen. The balloon catheter further includes a first configuration and a second configuration. When in the first configuration, the expandable balloon is disposed distally from the sheath such that an outer surface of the expandable balloon does not contact the lumen. Further, when in the second configuration, at least a portion of the outer surface of the expandable balloon is disposed within the lumen of the sheath such that it contacts the therapeutic agent. At least a portion of the therapeutic agent that contacts the outer surface of the expandable balloon is transferred from the lumen of the sheath to the outer surface of the expandable balloon when the balloon catheter is in the second configuration.

Claims

1. :

A balloon catheter, comprising;

an elongated catheter shaft comprising a proximal end and a distal end, wherein the elongated catheter shaft defines a longitudinal axis extending between the proximal end and the distal end;

an expandable balloon connected to the elongated catheter shaft adjacent the distal end of the elongated catheter shaft, wherein the expandable balloon comprises an outer surface; and

a sheath comprising an inner surface defining a lumen and a therapeutic agent disposed within the lumen of the sheath, wherein at least a portion of the elongated catheter shaft is disposed within the lumen of the sheath;

wherein the balloon catheter further comprises a first configuration and a second configuration, wherein the expandable balloon and the sheath are configured for movement relative to each other along the longitudinal axis of the elongated catheter shaft between the first configuration and the second configuration, wherein when in the first configuration the expandable balloon is disposed distally from the sheath such that the outer surface of the expandable balloon does not contact the lumen of the sheath, wherein when in the second configuration at least a portion of the outer surface of the expandable balloon is disposed within the lumen of the sheath such that it contacts the therapeutic agent, and wherein at least a portion of the therapeutic agent that contacts the outer surface of the expandable balloon is transferred from the lumen of the sheath to the outer surface of the expandable balloon when the balloon catheter is in the second configuration.

2. :

The balloon catheter of claim 1, wherein the sheath comprises an elastomeric material.

3. :

The balloon catheter of claim 1, wherein the expandable balloon comprises a polymeric material.

4. :

The balloon catheter of claim 1, wherein the therapeutic agent is disposed on the inner surface of the lumen of the sheath.

5. :

The balloon catheter of claim 1, wherein the lumen of the sheath further comprises a substrate connected to the inner surface of the sheath, the substrate comprising the therapeutic agent.

6. :

The balloon catheter of claim 5, wherein the substrate is selected from the group consisting of a film, a gel, and a matrix.

7. :

The balloon catheter of claim 1, wherein the elongated catheter shaft comprises an outer surface that is friction-fit with the inner surface of the sheath.

8. :

The balloon catheter of claim 1, wherein expansion of the expandable balloon when the balloon catheter is in the second configuration expands the sheath.

9. :

The balloon catheter of claim 1, wherein the elongated catheter shaft comprises an inflation lumen disposed along the longitudinal axis that is in fluid communication with the expandable balloon.

10. :

The balloon catheter of claim 1, wherein the elongated catheter shaft comprises a guidewire lumen disposed along the longitudinal axis.

11. :

The balloon catheter of claim 1, wherein no therapeutic agent is disposed on the surface of the expandable balloon when the balloon catheter is in the first configuration.

12. :

A method of delivering a therapeutic agent to a treatment site disposed on an inner surface of a vessel, comprising;

advancing an expandable balloon into the vessel with an elongated catheter shaft comprising a proximal end and a distal end, wherein the expandable balloon is connected to the elongated catheter shaft adjacent the distal end of the elongated catheter shaft;

inflating the expandable balloon such that an outer surface of the expandable balloon contacts the treatment site;

deflating the expandable balloon;

advancing a sheath into the vessel over the elongated catheter shaft such that a distal end of the sheath is adjacent the expandable balloon, wherein the sheath comprises an inner surface that defines a lumen and a therapeutic agent disposed within the lumen of the sheath;

positioning at least a portion of the expandable balloon within the sheath such that the outer surface of the expandable balloon contacts the therapeutic agent within the lumen of the sheath, thereby transferring at least a portion of the therapeutic agent from the lumen of the sheath to the outer surface of the expandable balloon;

advancing the expandable balloon beyond the distal end of the sheath; and

re-inflating the expandable balloon such that the outer surface of the expandable balloon contacts the treatment site.

13. :

The method of claim 12, wherein the therapeutic agent is disposed on the inner surface of the sheath.

14. :

The method of claim 12, wherein the lumen of the sheath further comprises a substrate connected to the inner surface of the sheath, the substrate comprising the therapeutic agent.

15. :

The method of claim 14, wherein the substrate is selected from the group consisting of a film, a gel, and a matrix.

16. :

The method of claim 12, further comprising withdrawing the sheath from the vessel.

17. :

The method of claim 12, further comprising;

deflating the expandable balloon; and

withdrawing the expandable balloon from the vessel.

18. :

The method of claim 12, wherein positioning the at least a portion of the expandable balloon within the sheath comprises;

moving the sheath relative to the expandable balloon such that the at least a portion of the expandable balloon is disposed within the lumen of the sheath; and

inflating the expandable balloon such that the outer surface of the expandable balloon contacts the substrate or inner surface of the sheath.

19. :

The method of claim 18, further comprising deflating the expandable balloon after transferring the at least a portion of the therapeutic agent from the substrate or inner surface of the sheath to the outer surface of the expandable balloon.

20. :

The method of claim 12, wherein positioning the at least a portion of the expandable balloon within the sheath comprises advancing the sheath over the expandable balloon such that the sheath is between the treatment site and the expandable balloon.

21. :

The method of claim 12, wherein positioning the at least a portion of the expandable balloon within the sheath comprises withdrawing the expandable balloon from the treatment site and into the sheath.

22. :

A method of delivering a therapeutic agent to a treatment site disposed on an inner surface of a vessel, comprising;

advancing an elongated catheter shaft, an expandable balloon, and a sheath into the vessel, wherein the elongated catheter shaft comprises a proximal end and a distal end, wherein the expandable balloon is connected to the elongated catheter shaft adjacent the distal end of the elongated catheter shaft, wherein the sheath comprises an inner surface defining a lumen and a therapeutic agent disposed within the lumen of the sheath, and wherein at least a portion of the elongated catheter shaft is disposed within the lumen of the sheath and a distal end of the sheath is adjacent the expandable balloon;

inflating the expandable balloon such that an outer surface of the expandable balloon contacts the treatment site;

deflating the expandable balloon;

positioning at least a portion of the expandable balloon within the sheath such that the outer surface of the expandable balloon contacts the therapeutic agent within the lumen of the sheath, thereby transferring at least a portion of the therapeutic agent from the lumen of the sheath to the outer surface of the expandable balloon;

advancing the expandable balloon beyond the distal end of the sheath; and

re-inflating the expandable balloon such that the outer surface of the expandable balloon contacts the treatment site.

23. :

The method of claim 22, wherein the therapeutic agent is disposed on the inner surface of the sheath.

24. :

The method of claim 22, wherein the lumen of the sheath further comprises a substrate connected to the inner surface of the sheath, the substrate comprising the therapeutic agent.

25. :

The method of claim 24, wherein the substrate is selected from the group consisting of a film, a gel, and a matrix.

26. :

The method of claim 22, further comprising withdrawing the sheath from the vessel.

27. :

The method of claim 22, further comprising;

deflating the expandable balloon; and

withdrawing the expandable balloon from the vessel.

28. :

The method of claim 22, wherein positioning the at least a portion of the expandable balloon within the sheath comprises;

moving the sheath relative to the expandable balloon such that the at least a portion of the expandable balloon is disposed within the lumen of the sheath; and

inflating the expandable balloon such that the outer surface of the expandable balloon contacts the substrate or inner surface of the sheath.

29. :

The method of claim 28, further comprising deflating the expandable balloon after transferring the at least a portion of the therapeutic agent from the substrate or inner surface of the sheath to the outer surface of the expandable balloon.

30. :

The method of claim 22, wherein positioning the at least a portion of the expandable balloon within the lumen of the sheath comprises advancing the sheath over the expandable balloon such that the sheath is between the treatment site and the expandable balloon.

31. :

The method of claim 22, wherein positioning the at least a portion of the expandable balloon within the lumen of the sheath comprises withdrawing the expandable balloon from the treatment site and into sheath.