LOW PROFILE OCCLUSION CATHETER

• US 20160213893A1
• Filed: 09/09/2014
• Published: 07/28/2016
• Est. Priority Date: 09/09/2013
• Status: Active Grant

• Current Assignee: Prytime Medical Devices, Inc.
• Original Assignee: Pryor Medical Devices, Inc.
• Inventors: FRANKLIN, Curtis J.
• Granted Patent: US 10,569,062 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61L 2400/16 Materials with shape-memory or superelastic properties
• CPC Class Codes: A61L 29/02 Inorganic materials
• CPC Class Codes: A61L 29/04 Macromolecular materials
• CPC Class Codes: A61L 29/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 29/18 Materials at least partially X-ray or laser opaque
• CPC Class Codes: A61M 2025/0002 with a pressure sensor at the distal end
• CPC Class Codes: A61M 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/008 Strength or flexibility characteristics of the catheter tip
• CPC Class Codes: A61M 25/1006 Balloons formed between concentric tubes
• CPC Class Codes: C08L 77/12 Polyester-amides

Abstract

A low profile occlusion catheter having a guiding atraumatic tip that prevents entry of the balloon into collateral vessels. The occlusion catheter system is particularly well suited for use in vascular occlusion and includes a pressure monitoring line to monitor the degree and state of occlusion.

Claims

1. A occlusion catheter system comprising:

a first catheter member having a first lumen extending longitudinally through the first catheter member and a first opening at a distal end of the first catheter member;

a second catheter member having a second lumen extending longitudinally through the second catheter member and a second opening at a distal end of the second catheter member, the second catheter member is positioned over and in spaced apart relationship relative to a proximal section of the first catheter member forming an annular space between the second catheter member and the first catheter member, the proximal section of the first catheter member resides within the second lumen of the second catheter member and the first catheter member extends beyond the distal end of the second catheter member,

a third catheter member having a third lumen extending longitudinally through the third catheter member and a third opening proximate a distal end of the third catheter member;

the third catheter member is positioned over a distal section of the first catheter member, the third catheter member having a distal section that extends distally from a distal end of the first catheter member such that the first lumen and the third lumen are in fluid flow communication, whereby the second and third catheter members are spaced apart from each other along a longitudinal axis of the first catheter member with the first catheter member extending there between;

an atraumatic tip member having a proximal section co-axially coupled proximate to a distal end of the third catheter member; and

an expandable occlusion member coupled to the second catheter member near the distal end of the second catheter member and to the third catheter member near a proximal end of the third catheter member, the expandable occlusion member being positioned such that a space between the distal end of the second catheter member and the proximal end of the third catheter member is within the expandable occlusion member.

2. The occlusion catheter system of claim 1, wherein the atraumatic tip is formed of a biocompatible polymer.

4. The occlusion catheter system of claim 1, wherein the proximal section of the atraumatic tip has a generally circular transverse cross-sectional profile and the atraumatic tip further comprises a distal section having a generally flattened cylindrical shape.

8. The occlusion catheter system of claim 1, wherein the atraumatic tip is fabricated of a biocompatible metal.

9. The occlusion catheter system of claim 1, further comprising a pressure sensor operably associated within the first lumen and being in fluid communication with a pressure port, the pressure port positioned distally relative to the occlusion member.

10. The occlusion catheter system of claim 9, wherein the pressure port passes through a wall surface of the third catheter member and is in fluid flow communication with the third lumen.

11. The occlusion catheter system of claim 1, further comprising a proximal hub coupled to and in fluid flow communication with each of the first catheter member, the second catheter member and the third catheter member, the proximal hub including a first fluid pathway and a second fluid pathway, the first fluid pathway in fluid communication with the first and third lumens and the second fluid pathway in fluid communication with the second lumen.

12. The occlusion catheter system of claim 11, further comprising a fluid source coupled to the proximal hub and in fluid flow communication with the second catheter member and the occlusion member.

13. The occlusion catheter system of claim 1, further comprising a pressure sensor operably coupled to the proximal hub an in communication with the first catheter member.

17. The occlusion catheter system of claim 1, wherein a greatest outer diameter of the occlusion catheter system is less than 2.3 mm when the expandable occlusion member is not expanded.

18. The occlusion catheter system of claim 1, wherein the expandable occlusion member is a balloon.

19. The occlusion catheter system of claim 18, further comprising:

a radio opaque marker fixed to the atraumatic tip to provide a visual indication of the location of the catheter system during deployment when the radio opaque marker is irradiated.

20. The occlusion catheter system of claim 1, wherein a first radio opaque marker is affixed near a first attachment point for coupling a proximal end of the expandable occlusion member to the second catheter member and

a second radio opaque marker is affixed near a second attachment point for coupling a distal end of the expandable occlusion member to the third catheter member.

22. The occlusion catheter system of claim 19, where the radio opaque marker is formed of a material selected from the group consisting of stainless steel, platinum iridium, a polymer mixed with a radio opaque material, barium sulfate, nitinol, a nitinol reinforced polymer and a suitable radio opaque alloy.

58. The occlusion catheter system of claim 1, further comprising pressure sensor wires extending from the proximal section of the first catheter member to a position between the atraumatic tip and the expandable occlusion member.

3. (canceled)

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28. The balloon catheter occlusion system of claim 25, wherein the atraumatic tip is formed of a material selected from the group consisting of an elastomeric polymer, a biocompatible polymer, a metal-reinforced polymer and a biocompatible metal.

26. A balloon catheter vascular occlusion system comprising:

a first catheter member having a first lumen passing longitudinally through the first catheter member, a first proximal end and a first distal end with a first distal opening;

a second catheter member having a second lumen passing longitudinally through the second catheter member, a second proximal end and a second distal end, the second catheter member being joined to the first catheter member near the first and second proximal ends such that the first lumen is positioned substantially co-axial with the second lumen;

a third catheter member having a third lumen passing longitudinally therethrough, a third proximal end and a third distal end defining a third distal opening, the third proximal end coupled to the first distal end near the first distal opening such that the first lumen is in fluid communication with the third lumen,

an atraumatic tip coupled to the third distal end to close the third distal opening and projecting distally therefrom, the atraumatic tip configured to track along major vessels while preventing entry into collateral vessels;

an occlusion balloon having a proximal balloon end and a distal balloon end and being in fluid flow communication with the second lumen of the second catheter member, the proximal balloon end connected to the second distal end and the distal balloon end connected to the third proximal end; and

a pressure sensing port extending through at least one of the first catheter member and the third catheter member between the distal balloon end and the atraumatic tip.

31. The occlusion catheter system of claim 26, further comprising a proximal hub coupled having a first channel communicating with the first lumen of the first catheter member.

33. The balloon catheter occlusion system of claim 26, wherein the third catheter member has distally increasing flexibility.

36. The balloon catheter occlusion system of claim 26, wherein a greatest outer diameter of the occlusion system is less than 2.3 mm when the occlusion balloon is not expanded.

37. The occlusion catheter system of claim 26, further comprising:

a radio opaque marker fixed to the catheter system to provide a visual indication of the location of the catheter system during deployment when the radio opaque marker is irradiated.

38. The occlusion catheter system of claim 37, wherein the radio opaque marker is a first radio opaque marker fixed to the occlusion catheter system near a first attachment point for coupling the proximal balloon end to the second catheter and

a second radio opaque marker fixed to the occlusion catheter system near a second attachment point for coupling the distal balloon end to the third catheter.

39. The occlusion catheter system of claim 37, wherein the radio opaque marker is fixed to the atraumatic tip.

40. The occlusion catheter system of claim 37, wherein the radio opaque marker is formed of a material selected from the group consisting of stainless steel, radio opaque alloy, a platinum iridium alloy, a polymer and barium sulfate.

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