System and method for low profile occlusion balloon catheter

• US 10,368,872 B2
• Filed: 06/02/2017
• Issued: 08/06/2019
• Est. Priority Date: 06/02/2016
• Status: Active Grant

• Current Assignee: Prytime Medical Devices, Inc.
• Original Assignee: Prytime Medical Devices, Inc.
• Inventors: Franklin, Curtis J., Krummenacher, Todd J., Reynolds, Jeremy, Spencer, David, Fisher, Luke William
• Primary Examiner(s): Ulsh, George J
• Application Number:
  US15/573,054
• Publication Number:
  US 20190076152A1
• Time in Patent Office: 795 Days
• CPC Class Codes: A61B 17/12036 partial occlusion
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2017/22055 with three or more balloons
• CPC Class Codes: A61M 2025/0002 with a pressure sensor at the distal end
• CPC Class Codes: A61M 2025/0003 having an additional lumen transmitting fluid pressure to the outside for measurement
• CPC Class Codes: A61M 2025/024 having a clip or clamp system
• CPC Class Codes: A61M 2025/028 having a mainly rigid support structure
• CPC Class Codes: A61M 2025/0286 anchored in the skin by suture or other skin penetrating devices
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/1056 having guide wire lumens outside the main shaft, i.e. the guide wire lumen is within or on the surface of the balloon
• CPC Class Codes: A61M 2025/1061 having separate inflations tubes, e.g. coaxial tubes or tubes otherwise arranged apart from the catheter tube
• CPC Class Codes: A61M 2025/1084 having features for increasing the shape stability, the reproducibility or for limiting expansion, e.g. containments, wrapped around fibres, yarns or strands
• CPC Class Codes: A61M 2025/1088 having special surface characteristics depending on material properties or added substances, e.g. for reducing friction
• CPC Class Codes: A61M 2025/1095 with perfusion means for enabling blood circulation while the balloon is in an inflated state or in a deflated state, e.g. permanent by-pass within catheter shaft
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• 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 25/02 Holding devices, e.g. on the body
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• 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 25/10184 : Means for controlling or monitoring inflation or deflation
• CPC Class Codes: A61M 25/104 : used for angioplasty

Abstract

An occlusion catheter system includes an inflation catheter member and an occlusion balloon. The proximal and distal balloon ends are connected to the inflation catheter between the proximal and distal catheter ends. A distal pressure sensor is attached to the inflation catheter member between the proximal balloon end and the atraumatic tip. An inflatable spine is connected to the inflation catheter. The proximal spine end is connected to the inflation catheter near the proximal balloon end and the distal spine end is connected to the inflation catheter near the distal balloon end. The occlusion balloon and the inflatable spine are configured to define blood flow channels with the internal surface and the external balloon surface when the occlusion catheter system is at least partially positioned in the vessel and the occlusion balloon and the inflatable spine are in a partially inflated configuration.

Claims

1. An occlusion catheter system for occlusion or partial occlusion of a relatively large vessel having an internal surface, the occlusion catheter system comprising:

an inflation catheter member having a stiffener member, a first inflation lumen, a proximal catheter end and a distal catheter end, the inflation catheter member defining a longitudinal axis, the inflation catheter member having an atraumatic tip on the distal catheter end;

an occlusion balloon having an internal balloon space, an external balloon surface, a proximal balloon end and a distal balloon end, the proximal and distal balloon ends connected to the inflation catheter between the proximal catheter end and the distal catheter end, the occlusion balloon substantially centered along the longitudinal axis in an inflated configuration, the first inflation lumen being in fluid communication with the internal balloon space;

a distal pressure sensor attached to the inflation catheter member between the distal balloon end and the atraumatic tip; and

an inflatable spine having an internal spine space, an external spine surface, a proximal spine end and a distal spine end, the proximal and distal spine ends connected to the inflation catheter, a portion of the external balloon surface contacting the external spine surface when the occlusion balloon and the inflatable spine are in an inflated configuration, the proximal spine end connected to the inflation catheter near the proximal balloon end and the distal spine end connected to the inflation catheter near the distal balloon end, the occlusion balloon and the inflatable spine configured to define blood flow channels with the internal surface and the external balloon surface when the occlusion catheter system is at least partially positioned in the vessel and the occlusion balloon and the inflatable spine are in a partially inflated configuration, the inflatable spine has a substantially constant spine diameter between the proximal spine end and the distal spine end in partially and fully inflated configurations.

2. The occlusion catheter system of claim 1 wherein the occlusion balloon has an occlusion diameter, the occlusion diameter being at least twice the spine diameter when the occlusion balloon and the inflatable spine are inflated at a partial inflation pressure.

3. The occlusion catheter system of claim 1, wherein the first inflation lumen is in fluid communication with the inflatable spine.

4. The occlusion catheter system of claim 1, wherein the inflation catheter member includes a second inflation lumen, the second inflation lumen being in fluid communication with the inflatable spine.

5. The occlusion catheter system of claim 1, wherein the occlusion balloon is constructed of a compliant polymeric material and the inflatable spine is constructed of a non-compliant material.

6. The occlusion catheter system of claim 1, wherein the pressure sensor is comprised of an electronic pressure sensor.

7. The occlusion catheter system of claim 1, wherein the pressure sensor is comprised of a distal side port in the inflation catheter member, the stiffener member including a lumen therein, the distal side portion in fluid communication with the lumen in the stiffener member.

8. The occlusion catheter system of claim 7, wherein the stiffener member is comprised of a hypotube and the lumen is comprised of a hypotube lumen.

9. The occlusion catheter system of claim 8, wherein the hypotube is constructed of a nitinol material.

10. The occlusion catheter system of claim 1, wherein the occlusion balloon and the inflatable spine are configured such that the occlusion balloon over-drives and substantially flattens the inflatable spine against the internal surface in the fully inflated configuration.

11. The occlusion catheter system of claim 1, wherein the atraumatic tip is comprised of a generally flattened cylinder having two generally planar opposing surfaces.

12. The occlusion catheter system of claim 1, further comprising:

a proximal pressure sensor mounted to the catheter member proximally relative to the occlusion balloon.

13. The occlusion catheter system of claim 12, further comprising:

a controller in communication with the proximal and distal pressure sensors; and

a pump in fluid communication with the occlusion balloon and the inflatable spine, the controller configured to one of introduce pressurized fluid into the occlusion balloon and the inflatable spine and withdraw fluid from the occlusion balloon and the inflatable spine based on pressure measurements from the proximal and distal pressure sensors.

14. The occlusion catheter system of claim 1, further comprising:

a control hub mountable to the catheter member near the proximal catheter end, the control hub including a display screen and a power source, the control hub configured to depict pressure on the display screen from the distal pressure sensor.

15. An occlusion catheter system for occlusion or partial occlusion of a relatively large vessel having an internal surface, the occlusion catheter system comprising:

an inflation catheter member having a stiffener member, a first inflation lumen, a second inflation lumen, a proximal catheter end and a distal catheter end, the inflation catheter member defining a longitudinal axis, the inflation catheter member having an atraumatic tip on the distal catheter end;

an occlusion balloon having an internal balloon space, an external balloon surface, a proximal balloon end and a distal balloon end, the proximal and distal balloon ends connected to the inflation catheter between the proximal catheter end and the distal catheter end, the occlusion balloon substantially centered along the longitudinal axis in an inflated configuration, the first inflation lumen being in fluid communication with the internal balloon space;

a distal pressure sensor attached to the inflation catheter member between the proximal balloon end and the atraumatic tip; and

an inflatable spine having an internal spine space, an external spine surface, a proximal spine end and a distal spine end, the proximal and distal spine ends connected to the inflation catheter, the internal spine space being in fluid communication with the second inflation lumen, a portion of the external balloon surface contacting the external spine surface when the occlusion balloon and the inflatable spine are in an inflated configuration, the proximal spine end connected to the inflation catheter near the proximal balloon end and the distal spine end connected to the inflation catheter near the distal balloon end, the inflatable spine has a substantially constant spine diameter between the proximal spine end and the distal spine end in partially and fully inflated configurations.

16. The occlusion catheter system of claim 15, wherein the occlusion balloon is constructed of a compliant polymeric material and the inflatable spine is constructed of a non-compliant material.

17. The occlusion catheter system of claim 16, wherein the occlusion balloon is constructed of a compliant first polyurethane material and the inflatable spine is constructed of non-compliant second polyurethane material, the first polyurethane material having a first durometer and the second polyurethane material having a second durometer, the second durometer being greater than the first durometer.

18. The occlusion catheter system of claim 15, wherein the occlusion balloon and the inflatable spine are configured to define blood flow channels with the internal surface and the external balloon surface when the occlusion catheter system is at least partially positioned in the vessel and the occlusion balloon and the inflatable spine are in the partially inflated configuration.

19. The occlusion catheter system of claim 15, wherein the occlusion balloon and the inflatable spine are configured such that the occlusion balloon over-drives and substantially flattens the inflatable spine against the internal surface in the fully inflated configuration.

20. The occlusion catheter system of claim 15, wherein the inflation catheter member includes a stiffener member extending substantially coaxially and substantially defining the longitudinal axis.

21. The occlusion catheter system of claim 20, wherein the stiffener member is comprised of a hypotube.

22. The occlusion catheter system of claim 15, wherein the pressure sensor is comprised of an electronic pressure sensor.

23. The occlusion catheter system of claim 15, further comprising:

a proximal pressure sensor mounted to the catheter member proximally relative to the occlusion balloon.

24. The occlusion catheter system of claim 23, further comprising:

a controller in communication with the proximal and distal pressure sensors; and

a pump in fluid communication with the occlusion balloon and the inflatable spine, the controller configured to one of introduce pressurized fluid into the occlusion balloon and the inflatable spine and withdraw fluid from the occlusion balloon and the inflatable spine based on pressure measurements from the proximal and distal pressure sensors.

25. The occlusion catheter system of claim 15, further comprising:

a control hub mountable to the catheter member near the proximal catheter end, the control hub including a display screen and a power source, the control hub configured to depict pressure on the display screen from the distal pressure sensor.