DEVICES, METHODS AND KITS FOR DELIVERY OF THERAPEUTIC MATERIALS TO A PANCREAS

• US 20140276135A1
• Filed: 06/02/2014
• Published: 09/18/2014
• Est. Priority Date: 12/02/2009
• Status: Active Grant

• Current Assignee: RenovoRx
• Original Assignee: RenovoRx
• Inventors: Agah, Ramtin, Najmabadi, Kamran, Zanchi, Marta Gaia
• Granted Patent: US 9,457,171 B2
• Time in Patent Office: Days
• US Class Current: 600/485
• 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:

a handle;

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

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

an actuator coupled to handle and configured to move the outer catheter relative to the handle;

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 the outer catheter is moved relative to the handle by the actuator.

2. The apparatus of claim 1, wherein the actuator is configured to move between a first position in which the first occlusion element is at a first distance form the second occlusion element and a second position in which the first occlusion element is at a second distance from the second occlusion element.

3. The apparatus of claim 1, further comprising a port coupled to the handle, the port defining a lumen in fluid communication with the first lumen of the second catheter, the 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 pancreatic arteries.

4. The apparatus of claim 3, wherein the port moves with the second catheter when the second catheter is moved relative to the handle by the actuator.

5. The apparatus of claim 1, further comprising:

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

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

7. The apparatus of claim 1, wherein when the first occlusion element and the second occlusion element are disposed within a target pancreatic artery, the first occlusion element and the second occlusion element define an isolated region of the target pancreatic artery, the distal opening being disposed between the first occlusion element and the second occlusion element within the isolated region.

8. An apparatus, comprising:

a handle;

an inner catheter coupled to the handle;

an outer catheter movably coupled to the handle, the outer catheter defining a first lumen in fluid communication with a distal opening and configured to introduce a therapeutic agent through the distal opening and into one or more target pancreatic 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; and

an actuator coupled to the handle and configured to move the outer catheter relative to the handle 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

9. The apparatus of claim 8, wherein the actuator is configured to move the outer catheter relative to the inner catheter when the outer catheter is moved between the first position and the second position.

10. The apparatus of claim 8, further comprising a port coupled to the handle, the port defining a lumen in fluid communication with the first lumen of the second catheter, the 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 pancreatic arteries.

11. The apparatus of claim 8, wherein the port moves between a first location relative to the handle when the second catheter is in the first position and a second location relative to the handle when the second catheter is in the second position.

12. The apparatus of claim 8, further comprising:

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

13. The apparatus of claim 8, wherein when the first occlusion element and the second occlusion element are disposed within a target pancreatic artery, the first occlusion element and the second occlusion element define an isolated region of the target pancreatic artery, the first lumen of the outer catheter being configured to introduce a therapeutic agent into the isolated region via the distal opening.

14. The apparatus of claim 12, wherein a distance between the first occlusion element and the sealing element can be adjusted.

15. The apparatus of claim 8, wherein when the first occlusion element and the second occlusion element are disposed within a target pancreatic artery, the first occlusion element and the second occlusion element define an isolated region of the target pancreatic artery, the distal opening being disposed between the first occlusion element and the second occlusion element within the isolated region.

16. A kit, comprising:

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

the catheter device including an actuator coupled to the handle and configured to move the outer catheter relative to the inner catheter such that a distance between the distal occlusion element and the proximal occlusion element varies; and

one or more therapeutic agent for delivery to a pancreas via the catheter device.

17. The kit of claim 16, 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.

18. The kit of claim 16, further comprising:

a manometer to monitor a pressure in an isolated area of a pancreatic artery.

19. The kit of claim 16, 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 a pancreatic artery.

20. The kit of claim 16, 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.

21. The kit of claim 16, wherein the one or more therapeutic agent includes stem cells.