Occlusion catheter system and methods of use

• US 10,099,040 B2
• Filed: 12/03/2015
• Issued: 10/16/2018
• Est. Priority Date: 06/03/2013
• Status: Active Grant

• Current Assignee: RenovoRx
• Original Assignee: RenovoRx
• Inventors: Agah, Ramtin, Najmabadi, Kamran, Bagai, Shaun R., Malek, Reza
• Primary Examiner(s): Gilbert, Andrew
• Application Number:
  US14/958,428
• Publication Number:
  US 20170157370A1
• Time in Patent Office: 1,048 Days
• CPC Class Codes: A61B 17/1214 Coils or wires
• CPC Class Codes: A61M 2025/0037 characterized by lumina being arranged side-by-side
• 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 2025/1045 for treating bifurcations, e.g. balloons in y-configuration, separate balloons or special features of the catheter for treating bifurcations
• 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 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2210/1042 Alimentary tract A61M2210/0618 takes precedence
• CPC Class Codes: A61M 2210/12 Blood circulatory system
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 39/24 Check- or non-return valves

Abstract

In some embodiments, an apparatus includes a first catheter movably disposed within a first lumen of a second catheter. The first catheter has a first occlusion member disposed at a distal end portion and the second catheter has a second occlusion member disposed at a distal end portion. A third catheter has a third occlusion member disposed at a distal end portion and is moveably disposable within a second lumen of the second catheter. The second catheter has a side port in fluid communication with the second lumen and the third catheter can be extended out of the second lumen through the side port. The first occlusion member, second occlusion member and third occlusion member can collectively isolate a target region including a portion of a first body lumen (e.g., a main vessel) and a portion of a second body lumen (e.g., a branch of the main vessel).

Claims

1. An apparatus, comprising:

a first catheter having a first occlusion member disposed at a distal end portion thereof;

a second catheter having a second occlusion member disposed at a distal end portion thereof, the second catheter defining a first lumen, a second lumen, and a side port in fluid communication with the second lumen, the first catheter being movably disposed within the first lumen of the second catheter, the first occlusion member and the second occlusion member collectively configured to define a first portion of an isolated target region in a first body lumen; and

a third catheter having a third occlusion member disposed at a distal end portion thereof, the third catheter being movable through the second lumen of the second catheter and configured to be disposed through the side port into a second body lumen outside of the second lumen,

the first occlusion member, the second occlusion member, and the third occlusion member collectively configured to define the isolated target region including the first portion of the isolated target region and a second portion of the isolated target region in the second body lumen, the isolated target region being fluidically isolated from other portions of the first body lumen and the second body lumen,

one of the first catheter or the second catheter defining an infusion lumen in communication with a side infusion port, the infusion lumen and the side infusion port configured to communicate an active therapeutic material into the isolated target region,

the side port having an outer diameter greater than an outer diameter of the side infusion port such that the third catheter can be disposed through the side port.

2. The apparatus of claim 1, wherein the first catheter and the second catheter are movably disposed relative to each other such that a distance between the first occlusion member and the second occlusion can be adjusted.

3. The apparatus of claim 1, wherein the one of the first catheter or the second catheter defining the infusion lumen in communication with the side infusion port is the second catheter.

4. The apparatus of claim 1, further comprising:

a sealing element coupled to the second catheter and covering at least in part the side port, the sealing element configured to permit the third catheter to exit the side port, the sealing element configured to prevent material from entering the side port from outside of the second catheter when the third catheter is not disposed in the side port.

5. The apparatus of claim 4, wherein the sealing element includes a one-way valve.

6. The apparatus of claim 1, further comprising:

a sealing element coupled to a distal end of the second catheter covering at least a portion of a distal opening of the second catheter, the sealing element configured to prevent material from entering the first lumen of the second catheter from outside the second catheter.

7. The apparatus of claim 6, wherein the sealing element includes a one-way valve.

8. The apparatus of claim 1, wherein each of the first occlusion member, the second occlusion member and the third occlusion member are inflatable.

9. The apparatus of claim 1, wherein the infusion lumen is configured to receive a guidewire that can be inserted through the infusion lumen into the isolated target region and used to perforate a portion of a vascular lumen disposed in the isolated target region.

10. The apparatus of claim 4, wherein the second catheter further defines the side infusion port, the side infusion port disposed on the second catheter longitudinally spaced from the side port.

11. The apparatus of claim 1, wherein at least one of the first body lumen or the second body lumen is a splenic artery, a pancreatic magnum artery, or a dorsal pancreatic artery, such that the isolated target region collectively defined by the first occlusion member, the second occlusion member, and the third occlusion member includes a portion of the splenic artery, the pancreatic magnum artery, or the dorsal pancreatic artery and a portion of an artery arising from the splenic artery, the pancreatic magnum artery, or the dorsal pancreatic artery.

12. An apparatus, comprising:

a first catheter including a first occlusion member disposed at a distal end portion thereof;

a second catheter including a second occlusion member disposed proximally of the first occlusion member at a distal end portion of the second catheter and at a spaced distance from the first occlusion member;

a third catheter including a third occlusion member,

at least one of the first catheter or the second catheter defining a first lumen in fluid communication with a first side port and a second lumen in fluid communication with a second side port, the first catheter and the second catheter configured to be inserted into an artery with the first occlusion member and the second occlusion member each in a collapsed configuration, the first occlusion member and the second occlusion member each being movable to an expanded configuration within the artery to define a isolated segment of the artery,

the second catheter defining a third lumen, the first catheter being movably disposed within the third lumen of the second catheter such that the first catheter and the second catheter are coaxial and a distance between the first occlusion member and the second occlusion member can be adjusted,

the first lumen and the first side port configured to communicate an active treatment material to the isolated segment of the artery,

the second lumen and the second side port configured to receive the third catheter such that the third occlusion member can be disposed through the second side port and into a side branch (1) in fluid communication with the artery and (2) located between the first occlusion member and the second occlusion member, the third occlusion member configured to occlude the side branch such that the first occlusion member, the second occlusion member, and the third occlusion member collectively define a fluidically isolated segment including the isolated segment of the artery and a portion of the side branch proximal to the third occlusion member; and

a sealing element covering the second side port, the sealing element configured to permit the third catheter to exit the second side port, the sealing element configured to prevent material from entering the second side port from outside of the second lumen when the third catheter is not disposed in the second side port.

13. The apparatus of claim 12, wherein the second catheter defines the first lumen, the first side port, the second lumen, and the second side port.

14. The apparatus of claim 12, wherein the sealing element includes a one-way valve.

15. The apparatus of claim 12, wherein

the third catheter defines a port configured to communicate a treatment agent to the side branch.

16. The apparatus of claim 12, wherein

the third catheter is configured to deliver a coil member to the side branch to permanently occlude the side branch.

17. The apparatus of claim 12, wherein the first lumen is configured to receive a guidewire that can be inserted through the first lumen into the fluidically isolated segment and used to perforate a portion of a vascular lumen disposed in the fluidically isolated segment.

18. A method, comprising

inserting into an artery a first catheter having a first occlusion member disposed at a distal end portion thereof and a second catheter having a second occlusion member disposed proximally of the first occlusion member and at a spaced distance from the first occlusion member, the second catheter defining (i) a first side port and a first lumen in fluid communication with the first side port and (ii) a second side port and a second lumen in fluid communication with the second side port, the first side port disposed distal to and radially offset from the second side port, the first occlusion member and the second occlusion member each being in a collapsed configuration when the first catheter and the second catheter are inserted into the artery,

the second catheter defining a third lumen, the first catheter being movably disposed within the third lumen of the second catheter such that the first catheter and the second catheter are coaxial and a distance between the first occlusion member and the second occlusion member can be adjusted;

moving each of the first occlusion member and the second occlusion member to an expanded configuration within the artery to define an isolated segment of the artery;

inserting through the second lumen and the second side port a treatment device having a third occlusion member that can be disposed through the second side port and into a side branch in fluid communication with the artery;

occluding the side branch with the third occlusion member such that the first occlusion member, the second occlusion member, and the third occlusion member collectively define a fluidically isolated treatment region including the isolated segment of the artery and a portion of the side branch between the artery and the third occlusion member; and

introducing through the first lumen and the first side port an active treatment material to the fluidically isolated treatment region.

19. The method of claim 18, further comprising:

introducing a coil device into the side branch using the treatment device to permanently occlude the side branch.

20. The method of claim 18, further comprising:

inserting through the first lumen a guidewire to the fluidically isolated treatment region; and

perforating a portion of a vascular lumen disposed in the fluidically isolated treatment region.