Occlusion perfusion catheter

• US 9,526,874 B2
• Filed: 04/07/2015
• Issued: 12/27/2016
• Est. Priority Date: 11/03/2008
• Status: Active Grant

• Current Assignee: Advanced Catheter Therapies, Inc.
• Original Assignee: Advanced Catheter Therapies, Inc.
• Inventors: Teeslink, C. Rex, Hoyns, Dirk V.
• Primary Examiner(s): BOUCHELLE, LAURA A
• Application Number:
  US14/680,233
• Publication Number:
  US 20150209560A1
• Time in Patent Office: 630 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 1/043 for fluorescence imaging
• CPC Class Codes: A61B 17/12045 double occlusion, e.g. during anastomosis
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 2017/00893 pharmaceutically effective
• CPC Class Codes: A61B 2017/12127 Double occlusion, e.g. for creating blood-free anastomosis site
• CPC Class Codes: A61B 5/02154 by optical transmission
• CPC Class Codes: A61B 5/02158 provided with two or more sensor elements
• CPC Class Codes: A61B 5/6853 with a balloon
• CPC Class Codes: A61M 1/90 Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 2025/1013 with concentrically mounted balloons, e.g. being independently inflatable
• 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 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 2025/1093 having particular tip characteristics
• CPC Class Codes: A61M 2025/1097 with perfusion means for enabling blood circulation only while the balloon is in an inflated state, e.g. temporary by-pass within balloon
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/3337 Controlling, regulating pressure or flow by means of a valve by-passing a pump
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 25/1011 : Multiple balloon catheters
• CPC Class Codes: A61M 39/24 : Check- or non-return valves
• CPC Class Codes: A61M 5/007 : for contrast media

Abstract

Catheters for occluding, visualizing, irrigating, evacuating, and delivering agents to a treatment area are disclosed. The catheters comprise a catheter body comprising five lumens, first and second occlusion balloons coupled to the catheter body, an optional space-occupying balloon coupled to the catheter body and disposed between the first and second occlusion balloons, and an optional visualization means that enables visualization between the first and second occlusion balloons. Methods for using these catheters are also disclosed. A method comprises inflating the first and second occlusion balloons, inflating the space-occupying balloon, allowing fluid to exit via an evacuation lumen, optionally irrigating or aspirating to facilitate fluid exit via said lumen, and delivering an agent to a treatment area via the agent lumen.

Claims

1. A method of accessing a biological space, comprising:

a) inserting a catheter into the biological space, said catheter comprising;

i) a catheter shaft having a longitudinal axis, a distal end having a shaft distal tip, and a proximal end;

ii) a first balloon positioned on the shaft proximal to the shaft distal tip and a second balloon positioned on the shaft proximal to the first balloon;

iii) an agent delivery orifice positioned between the first and second balloons;

iv) an agent aspiration orifice positioned between the first and second balloons; and

v) at least one pressure sensing means at said agent delivery orifice;

wherein said agent delivery orifice and said aspiration orifice lie on opposite sides of said longitudinal axis;

b) isolating a treatment region between said first and second balloons, in said biological space;

c) optionally;

i) evacuating the isolated treatment region; and

/or

ii) flushing the isolated treatment region;

d) introducing, via said agent delivery orifice, at least one agent into the isolated treatment region.

2. The method of claim 1, wherein said biological space is selected from the group consisting of:

a blood vessel of the cardiovascular system, an artery, a vein, a lymphatic vessel, a gastroesophageal tract, a porto-caval lumen, a gallbladder duct, a bile duct, a urinary system duct, a respiratory system duct, a duct of an endocrine organ, a duct of an exocrine organ, and a reproductive organ.

3. The method of claim 2, wherein said organ system is selected from the group consisting of:

liver, pancreas, kidney, stomach, duodenum, jejunum, ileum, appendix, colon, rectum, bladder, gallbladder, lung, heart, a lymph node, spleen, pituitary gland, pineal gland, thymus, ovary, testes, and thyroid.

4. The method of claim 3, wherein said organ system comprises a cancer.

5. The method of claim 4, wherein said at least one agent is a chemotherapeutic agent.

6. The method of claim 1, wherein said biological space is occluded, and said inserting comprises passing said catheter through said occlusion.

7. The method of claim 6, wherein said occlusion is a clot or a plaque.

8. The method of claim 7, wherein said at least one agent is a lytic agent.

9. The method of claim 1, wherein said at least one agent is selected from the group consisting of:

a drug, a solution, a cell, a protein, nucleic acids, a liposome, a micelle, a vector, a nanoparticle, a phospholipid, a lamellar layer, a liquid crystal, and combinations thereof.

10. A catheter comprising:

a) a catheter shaft having a longitudinal axis, a distal end having a shaft distal tip, and a proximal end;

b) a first balloon positioned on the shaft proximal to the shaft distal tip;

c) a second balloon positioned on the shaft proximal to the first balloon;

d) an agent delivery orifice positioned on the shaft between the first and second balloons;

e) at least one pressure sensing means at said delivery orifice; and

f) an aspiration orifice positioned on the shaft between the first and second balloons;

wherein said agent delivery orifice and said aspiration orifice lie on opposite sides of said longitudinal axis.

11. The catheter of claim 10, further comprising a third balloon positioned on the shaft between said first and second balloons, and between said agent delivery and aspiration orifices.

12. The catheter of claim 10, further comprising a third balloon positioned on the shaft between said first and second balloons, and between said agent delivery and aspiration orifices.

13. A method of accessing a biological space, comprising:

a) inserting the catheter of claim 10 into the biological space;

b) isolating a treatment region between said first and second balloons, in said biological space;

c) optionally;

i) evacuating the isolated treatment region; and

/or

ii) flushing the isolated treatment region;

d) introducing, via said agent delivery orifice, at least one first agent into the isolated treatment region;

e) optionally introducing, via said aspiration orifice, at least one second agent.

14. The method of claim 13, wherein said at least one second agent is introduced into the isolated treatment region via said agent delivery orifice, and said at least one second agent interacts chemically with the at least one first agent.