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

• US 9,457,171 B2
• Filed: 06/02/2014
• Issued: 10/04/2016
• 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:
  US14/293,603
• Publication Number:
  US 20140276135A1
• Time in Patent Office: 855 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 an inner catheter lumen configured to receive a guidewire;

an outer catheter defining a first lumen in fluid communication with an opening defined in a side wall at a distal end portion of the outer catheter and configured to introduce a therapeutic agent through the opening and into one or more target arteries, and a second lumen configured to receive at least a portion of the inner catheter;

a first port coupled to the outer catheter in fluid communication with the first lumen;

a second port coupled to the outer catheter in fluid communication with the second lumen;

a first occlusion element coupled to the inner catheter; and

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 when at least one of the outer catheter and the inner catheter is moved relative to other of the outer catheter and the inner catheter.

2. The apparatus of claim 1, wherein the first port is configured to be coupled to a source of a therapeutic agent to be introduced through the first lumen and into the one or more target arteries.

3. The apparatus of claim 1, further comprising:

a sealing element coupled to the outer catheter between the inner catheter and the outer catheter and configured to prevent a therapeutic agent from entering the second lumen of the outer catheter.

4. The apparatus of claim 1, wherein when the first occlusion element and the second occlusion element are disposed within a target artery from the one or more target arteries, the first occlusion element and the second occlusion element define an isolated region of the target artery, the first lumen of the outer catheter being configured to introduce a therapeutic agent into the isolated region via the opening.

5. The apparatus of claim 1, wherein when the first occlusion element and the second occlusion element are disposed within a target artery from the one or more target arteries, the first occlusion element and the second occlusion element define an isolated region of the target artery, the opening being disposed between the first occlusion element and the second occlusion element within the isolated region.

16. The apparatus of claim 1, wherein the one or more target arteries includes one of a pancreatic artery and a splenic artery.

19. The apparatus of claim 1, further comprising:

a third port coupled to the outer catheter and in fluid communication with a third lumen defined by the outer catheter, the third lumen being in fluid communication with the second occlusion element, the third port configured to be coupled to a source of an inflation medium and communicate the inflation medium to the second occlusion element.

20. The apparatus of claim 1, wherein the first port defines a lumen in fluid communication with the first lumen of the outer catheter, the first port configured to be coupled to a source of a therapeutic agent to be introduced through the first lumen and into the one or more target arteries,

the second port defines a lumen in fluid communication with the second lumen of the outer catheter and is configured to be coupled to an external device.

24. The apparatus of claim 1, further comprising:

a guidewire port coupled to the inner catheter lumen;

a third port coupled to the outer catheter and in fluid communication with a third lumen defined by the outer catheter, the third lumen being in fluid communication with the second occlusion element, the third port configured to be coupled to a source of an inflation medium and to communicate the inflation medium to the second occlusion element; and

a fourth port coupled to an inflation lumen defined by the inner catheter, the inflation lumen being in fluid communication with the first occlusion element, the fourth port configured to be coupled to a source of inflation medium and to communication the inflation medium to the first occlusion element;

the fourth port and the guidewire port being movable relative to the first port, the second port and the third port.

25. The apparatus of claim 24, wherein the first port, the second port and the third port are coupled to a portion of a handle that is fixed relative to the outer catheter and the guidewire port and the fourth port are movable relative to the portion of the handle.

26. The apparatus of claim 25, wherein when the guidewire port moves a first distance relative to the portion of the handle, the first occlusion element moves the first distance.

6. An apparatus, comprising:

a handle;

an inner catheter coupled to the handle the inner catheter defining an inner catheter lumen configured to receive a guidewire;

an outer catheter coupled to the handle, the outer catheter defining a first lumen in fluid communication with an opening defined in a side wall at a distal end portion of the outer catheter and configured to introduce a therapeutic agent through the opening and into one or more target arteries, and a second lumen configured to receive at least a portion of the inner catheter;

a first occlusion element coupled to the inner catheter;

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

a first port coupled to the handle and in fluid communication with the first lumen; and

a second port coupled to the handle and in fluid communication with the second lumen, at least one of the inner catheter and the outer catheter configured to be moved relative to the other of the inner catheter and the outer catheter between a first position in which the second occlusion element is at a first distance from the first occlusion element and a second position in which the second occlusion element is at a second distance from the first occlusion element, the second distance being greater than the first distance.

7. The apparatus of claim 6, wherein the first port defines a lumen in fluid communication with the first lumen of the outer catheter, the first port configured to be coupled to a source of a therapeutic agent to be introduced through the first lumen and into the one or more target arteries.

8. The apparatus of claim 6, further comprising:

a sealing element coupled to a distal end portion of the outer catheter between the inner catheter and the outer catheter and configured to prevent a therapeutic agent from entering the second lumen of the outer catheter.

9. The apparatus of claim 6, wherein when the first occlusion element and the second occlusion element are disposed within a target artery from the one or more target arteries, the first occlusion element and the second occlusion element define an isolated region of the target artery, the first lumen of the outer catheter being configured to introduce a therapeutic agent into the isolated region via the distal opening.

10. The apparatus of claim 8, wherein a distance between the first occlusion element and the sealing element can be adjusted.

11. The apparatus of claim 6, wherein when the first occlusion element and the second occlusion element are disposed within a target artery from the one or more target arteries, the first occlusion element and the second occlusion element define an isolated region of the target artery, the opening being disposed between the first occlusion element and the second occlusion element within the isolated region.

17. The apparatus of claim 6, wherein the one or more target arteries includes one of a pancreatic artery and a splenic artery.

21. The apparatus of claim 6, further comprising:

a third port coupled to the handle and in fluid communication with a third lumen defined by the outer catheter, the third lumen being in fluid communication with the second occlusion element, the third port configured to be coupled to a source of an inflation medium and communicate the inflation medium to the second occlusion element.

22. The apparatus of claim 6, wherein the first port defines a lumen in fluid communication with the first lumen of the outer catheter, the first port configured to be coupled to a source of a therapeutic agent to be introduced through the first lumen and into the one or more target arteries,

the second port defines a lumen in fluid communication with the second lumen of the outer catheter and is configured to be coupled to an external device.

12. A kit, comprising:

a catheter device including a handle, an outer catheter coupled to the handle, an inner catheter movably coupled to the outer catheter, a distal occlusion element coupled to the inner catheter, a proximal occlusion element coupled to the outer catheter, the outer catheter defining a first lumen in fluid communication with an opening defined in a side wall of the outer catheter and configured to introduce one or more therapeutic agent to one or more target arteries, and a second lumen configured to receive at least a portion of the inner catheter, the inner catheter and outer catheter configured to move relative to one another,

the handle including a first port defining a lumen in fluid communication with the first lumen of the outer catheter and configured to communicate a therapeutic agent to the first lumen and out the opening in the side wall of the outer catheter, and a second port defining a lumen in fluid communication with the second lumen of the outer catheter and configured to be coupled to an external device; and

one or more therapeutic agent for delivery to the one or more target arteries via the catheter device,

wherein the catheter device further includes a sealing element coupled to the outer catheter and configured to seal the second lumen of the outer catheter and prevent a therapeutic agent from entering into the second lumen wherein the inner catheter defines a lumen, the kit further comprising;

at least one of a stylet, a dilator, a guidewire, or a guide catheter configured to be slidably received within the lumen of the inner catheter.

13. The kit of claim 12, further comprising:

a manometer to monitor a pressure in an isolated area of a target artery from the one or more target arteries.

14. The kit of claim 12, further comprising:

a pump configured to be coupled to the catheter device via a port coupled to the handle and to regulate an infusion rate of the one or more therapeutic agent being delivered through the first lumen of the outer catheter and into the one or more target arteries.

15. The kit of claim 12, wherein the one or more therapeutic agent includes stem cells.

18. The kit of claim 12, wherein the one or more target arteries includes one of a pancreatic artery and a splenic artery.

23. The kit of claim 12, wherein the handle of the catheter device includes a third port in fluid communication with a third lumen defined by the outer catheter, the third lumen being in fluid communication with the second occlusion element, the third port configured to be coupled to a source of an inflation medium and communicate the inflation medium to the second occlusion element.