System and method for low-profile occlusion balloon catheter

• US 10,149,962 B2
• Filed: 03/18/2016
• Issued: 12/11/2018
• Est. Priority Date: 03/19/2015
• Status: Active Grant

• Current Assignee: Prytime Medical Devices, Inc.
• Original Assignee: Prytime Medical Devices, Inc.
• Inventors: Franklin, Curtis J., Spencer, David, Krummenacher, Todd J.
• Primary Examiner(s): Price, Nathan R
• Assistant Examiner(s): Doubrava, John
• Application Number:
  US15/551,504
• Publication Number:
  US 20180236203A1
• Time in Patent Office: 998 Days
• CPC Class Codes: A61B 17/12036 partial occlusion
• 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 2017/00017 Electrical control of surgical instruments
• CPC Class Codes: A61M 2025/0002 with a pressure sensor at the distal end
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/1059 having different inflatable sections mainly depending on the response to the inflation pressure, e.g. due to different material properties with different compartments A61M2025/1072
• CPC Class Codes: A61M 2025/1081 having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
• 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 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 2025/1093 having particular tip characteristics
• 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 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/008 Strength or flexibility characteristics of the catheter tip
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1006 Balloons formed between concentric tubes
• CPC Class Codes: A61M 25/10182 Injector syringes
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

An occlusion catheter system includes a proximal hub having an inflation connection port and an inflation pathway. An inflation catheter member is connected to the proximal hub and has an inflation lumen. A stiffener member defines a longitudinal axis. The proximal end of the stiffener member is connected to the proximal hub. The stiffener member extends through a portion of the inflation lumen. An occlusion balloon has a proximal balloon end and a distal balloon end. A distal catheter member is positioned substantially on the longitudinal axis and is connected to the distal end of the stiffener member. An atraumatic tip is positioned on a distal end of the distal catheter member. The atraumatic tip has a substantially circular profile in a relaxed configuration. A pressure sensor is connected to the occlusion catheter system distally relative to the occlusion balloon and is connected to a processor by electrical wiring.

Claims

1. An occlusion catheter system for occlusion of a relatively large vessel, the occlusion catheter system comprising:

a proximal hub having an inflation connection port and an inflation pathway defined in the connection port;

an inflation catheter member connected to the proximal hub, the inflation catheter member having an inflation lumen and a first port proximate a distal end of the inflation catheter member, the inflation catheter member defining a longitudinal axis;

an occlusion balloon having a proximal balloon end and a distal balloon end, the proximal balloon end connected proximate to the distal end of the inflation catheter;

the first port opening into an internal space of the occlusion balloon;

a distal catheter member positioned substantially on the longitudinal axis and connected to the distal balloon end;

an atraumatic tip on a distal end of the distal catheter member, the atraumatic tip having a substantially circular profile in a relaxed configuration with an unconnected end positioned proximate the longitudinal axis, the atraumatic tip including a tip shaft with a guide lumen therein and a flattened distal section having a solid substantially circular profile, the guide lumen including an exit port proximate the distal end of the atraumatic tip positioned proximate the longitudinal axis; and

a guide wire configured for slidable movement within the guide lumen and extendable out of the exit port beyond the atraumatic tip.

2. The occlusion catheter system of claim 1, wherein the catheter system is configured for removal from the vessel without removal of the guide wire.

3. The occlusion catheter system of claim 1, wherein the guide lumen has an internal guide diameter, the internal guide diameter sized to receive the guide wire, wherein the guide wire has a wire diameter of approximately eighteen thousandths of an inch (0.018″

) to approximately thirty-five thousandths of an inch (0.035″

).

4. The occlusion catheter system of claim 1, wherein the flattened distal section has an inner planar surface, an outer planar surface and opposing arcuate lateral surfaces.

5. The occlusion catheter system of claim 1, wherein the exit port is positioned on a lower side of the atraumatic tip, opposite the circular profile.

6. The occlusion catheter system of claim 1, wherein the exit port is positioned on an upper side of the atraumatic tip, proximate an inner surface of the circular profile.

7. The occlusion catheter system of claim 1, wherein a proximal end of the inflation catheter is connected to the proximal hub with an adhesive.

8. The occlusion catheter system of claim 1, wherein the inflation catheter, the distal catheter member and the atraumatic tip are constructed of a polymeric material.