Devices, methods and kits for delivery of therapeutic materials to a pancreas

• US 9,463,304 B2
• Filed: 09/30/2015
• Issued: 10/11/2016
• Est. Priority Date: 12/02/2009
• Status: Active Grant

• Current Assignee: RenovoRx
• Original Assignee: RenovoRx
• Inventors: Agah, Ramtin, Najmabadi, Kamran, Zanchi, Marta Gaia
• Primary Examiner(s): GILBERT, ANDREW M
• Application Number:
  US14/870,833
• Publication Number:
  US 20160015948A1
• Time in Patent Office: 377 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/1204 temporary occlusion
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61M 2025/0004 having two or more concentrically arranged tubes for forming a concentric catheter system
• CPC Class Codes: A61M 2025/0037 characterized by lumina being arranged side-by-side
• CPC Class Codes: A61M 2025/0175 having telescopic features, interengaging nestable members movable in relations to one another
• CPC Class Codes: A61M 2025/1015 having two or more independently movable balloons where the distance between the balloons can be adjusted, e.g. two balloon catheters concentric to each other forming an adjustable multiple balloon catheter system
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2210/00 Anatomical parts of the body
• CPC Class Codes: A61M 2210/10 Trunk
• CPC Class Codes: A61M 2230/30 Blood pressure A61M2230/04 takes precedence
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps

Abstract

An apparatus includes an inner catheter that is coupled to a handle and defines a lumen configured to receive a guidewire. An outer catheter is movably coupled to the handle and defines a first lumen in fluid communication with a distal opening and that is configured to introduce a therapeutic agent through the distal opening and into a target pancreatic artery(ies). The outer catheter defines a second lumen configured to receive at least a portion of the inner catheter. An actuator is coupled to the handle and configured to move the outer catheter relative to the handle. A first occlusion element is coupled to the inner catheter and a second occlusion element is coupled to the outer catheter and disposed proximal to the first occlusion element. A distance between the first occlusion element and the second occlusion element is adjustable when the outer catheter is moved relative to the handle.

Claims

1. An apparatus, comprising:

an inner catheter defining a guidewire lumen configured to receive a guidewire;

an outer catheter movably coupled to the inner catheter, the outer catheter and the inner catheter being coaxial, the outer catheter having a first lumen defined entirely by a side wall of the outer catheter in fluid communication with an infusion aperture defined by the side wall of the outer catheter proximal to a distal end of the outer catheter, the first lumen configured to introduce a therapeutic agent directly through the infusion aperture and into one or more target vessels, and a second lumen configured to receive at least a portion of the inner catheter;

a first occlusion element coupled to the inner catheter, the inner catheter further defining an inflation lumen configured to communicate an inflation medium to the first occlusion element;

a second occlusion element coupled to the outer catheter, the second occlusion element disposed proximal to the first occlusion element; and

a seal coupled between the inner catheter and the outer catheter and configured to fluidically isolate the first lumen of the outer catheter from the second lumen of the outer catheter,

the infusion aperture of the outer catheter being disposed between the first occlusion element and the second occlusion element, the first lumen being the only lumen that is in fluidic communication with a region defined between the first occlusion element and the second occlusion element.

2. The apparatus of claim 1, wherein a distance between the first occlusion element and the second occlusion element is adjustable when the outer catheter is moved relative to the inner catheter.

3. The apparatus of claim 1, further comprising a third lumen defined by the outer catheter, fluidically isolated from the first lumen and the second lumen of the outer catheter and configured to supply inflation fluid to the second occlusion element.

4. The apparatus of claim 1, wherein when the first occlusion element and the second occlusion element are configured to be disposed within a target pancreatic artery from the one or more target vessels.

17. The apparatus of claim 1, wherein the first occlusion element is coupled solely to the inner catheter and the second occlusion element is coupled solely to the outer catheter.

18. The apparatus of claim 1, wherein a distance between the first occlusion element and the seal can be adjusted.

19. The apparatus of claim 1, wherein a distance between the second occlusion element and the seal is fixed.

20. The apparatus of claim 1, wherein when the first occlusion element and the second occlusion element are disposed within a target artery, the first occlusion element and the second occlusion element define an isolated region of the target artery, the infusion aperture being disposed within the isolated region defined between the first occlusion element and the second occlusion element.

21. The apparatus of claim 1, wherein the seal is disposed distal to the infusion aperture.

5. An apparatus, comprising:

an inner catheter fixedly coupled to a first occlusion element and defining an inflation lumen fluidically coupled to the first occlusion element and a guidewire lumen configured to receive a guidewire therethrough;

an outer catheter movably coupled to the inner catheter and fixedly coupled to a second occlusion element, the outer catheter being coaxial with the inner catheter, the outer catheter defining a first lumen defined entirely by a side wall of the outer catheter and in fluid communication with an infusion aperture defined by the side wall of the outer catheter between the first occlusion element and the second occlusion element and configured to directly introduce a therapeutic agent through the infusion aperture and into one or more target arteries, and a second lumen configured to receive at least a portion of the inner catheter; and

a seal coupled between the inner catheter and the outer catheter and configured to fluidically isolate the second lumen of the outer catheter.

6. The apparatus of claim 5, wherein the outer catheter is configured to move from a first position relative to the inner catheter to a second position relative to the inner catheter.

7. The apparatus of claim 5, wherein the first occlusion element is configured to be spaced apart from the second occlusion element, the second occlusion element configured to move relative to the first occlusion element.

8. The apparatus of claim 5, wherein the outer catheter defines a third lumen fluidically associated with the second occlusion element.

9. The apparatus of claim 5, wherein a distance between the first occlusion element and the seal can be adjusted.

10. The apparatus of claim 5, wherein when the first occlusion element and the second occlusion element are disposed within a target artery, the first occlusion element and the second occlusion element define an isolated region of the target artery, the infusion aperture being disposed within the isolated region defined between the first occlusion element and the second occlusion element.

22. The apparatus of claim 5, wherein the first occlusion element is coupled solely to the inner catheter and the second occlusion element is coupled solely to the outer catheter.

23. The apparatus of claim 5, wherein a distance between the second occlusion element and the seal is fixed.

24. The apparatus of claim 5, wherein the seal is disposed distal to the infusion aperture.

11. An apparatus, comprising:

an inner catheter defining a guidewire lumen configured to receive a guidewire;

an outer catheter defining a first lumen terminating at an infusion aperture, the first lumen and the infusion aperture each defined entirely by a side wall of the outer catheter, the infusion aperture being in fluid communication with the first lumen, the first lumen configured to directly communicate a therapeutic agent to the infusion aperture and into one or more target arteries, and a second lumen configured to slidably receive at least a portion of the inner catheter, the outer catheter and the inner catheter being coaxial;

a first occlusion element coupled to the inner catheter, the inner catheter defining an inflation lumen configured to communicate an inflation medium to the first occlusion element;

a second occlusion element coupled to the outer catheter, the second occlusion element disposed proximal to the first occlusion element, a distance between the first occlusion element and the second occlusion element being adjustable; and

a sealing element coupled to the outer catheter and configured to fluidically isolate the second lumen of the outer catheter and prevent the therapeutic agent from entering the second lumen of the outer catheter when communicated out of the infusion aperture and into the one or more target arteries, the infusion aperture being disposed between the second occlusion element and the sealing element.

12. The apparatus of claim 11, wherein the first occlusion element includes one of an expandable filter and an inflatable balloon.

13. The apparatus of claim 11, wherein the first occlusion element and the second occlusion element define an isolated region of a targeted artery, the first lumen of the outer catheter is configured to allow atraumatic introduction of the therapeutic agent into the isolated region.

14. The apparatus of claim 11, wherein the first lumen of the outer catheter is configured to allow rapid infusion of the therapeutic agent.

15. The apparatus of claim 11, wherein a distance between the first occlusion element and the sealing element can be adjusted.

16. The apparatus of claim 11, wherein the outer catheter defines a third lumen fluidically isolated from the first lumen and the second lumen of the outer catheter and configured to supply inflation fluid to the second occlusion element.

25. The apparatus of claim 11, wherein the sealing element is coupled to the outer catheter between the inner catheter and the outer catheter.

26. The apparatus of claim 11, wherein the first occlusion element is coupled solely to the inner catheter and the second occlusion element is coupled solely to the outer catheter.

27. The apparatus of claim 11, wherein when the first occlusion element and the second occlusion element are disposed within a target artery, the first occlusion element and the second occlusion element define an isolated region of the target artery, the infusion aperture being disposed within the isolated region defined between the first occlusion element and the second occlusion element.

28. The apparatus of claim 11, wherein a distance between the second occlusion element and the seal is fixed.

29. The apparatus of claim 11, wherein the seal is disposed distal to the infusion aperture.