PERFUSION REGULATION SYSTEM

• US 20150018937A1
• Filed: 07/09/2014
• Published: 01/15/2015
• Est. Priority Date: 07/12/2013
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Lagodzki, Karol, Plassman, Trevor
• Granted Patent: US 9,468,737 B2
• Time in Patent Office: Days
• US Class Current: 623/1.24
• CPC Class Codes: A61B 2017/22065 Functions of balloons dilating A61M29/02
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61M 1/3613 Reperfusion, e.g. of the coronary vessels, e.g. retroperfusion
• CPC Class Codes: A61M 2025/0004 having two or more concentrically arranged tubes for forming a concentric catheter system
• CPC Class Codes: A61M 2025/0042 Microcatheters, cannula or the like having outside diameters around 1 mm or less
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• 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 2039/229 Stopcocks
• CPC Class Codes: A61M 25/0021 characterised by the form of the tubing A61M25/0054 takes precedence
• CPC Class Codes: A61M 25/0026 Multi-lumen catheters with stationary elements catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10
• CPC Class Codes: A61M 25/0662 Guide tubes

Abstract

A reperfusion system and method of perfusing a blood vessel using the reperfusion system are provided. The system includes an introducer sheath, a middle catheter extending through the introducer sheath, and a balloon microcatheter extending through the middle catheter. A connecting tube extends between a lumen of the introducer sheath and a valve at a proximal end of the microcatheter. A flow path is defined along a lumen of the introducer sheath, through the connecting tube, into the microcatheter, and out of a distal opening of the microcatheter. The balloon is disposed adjacent the exit point of the flow path to reduce reflux. Embolic material can be introduced into the microcatheter at the valve to exit at the same location as the blood flow.

Claims

1. A reperfusion catheter system comprising:

an introducer sheath having a wall defining a longitudinal lumen extending from a proximal portion to a distal end;

a middle catheter having a wall and having a longitudinal opening extending from a proximal portion to a distal end, the middle catheter disposed through the lumen of the introducer sheath;

a microcatheter having a wall and having a longitudinal lumen extending from a proximal portion to a distal end, the microcatheter disposed through the lumen in the middle catheter, the microcatheter having an inflatable balloon on the distal end;

a connecting tube having a first end disposed in fluid communication with the inside of the introducer sheath and a second end disposed in fluid communication with the microcatheter; and

an antegrade blood flow path defined between an inner surface of the introducer sheath and an outer surface of the middle catheter, through the connecting tube, through the proximal portion of the microcatheter, through the lumen of the microcatheter, and exiting the distal end of the microcatheter.

2. The system of claim 1 further comprising a valve disposed between the proximal portion of the microcatheter and the connecting tube, the valve having a first port and a second port, the first and second ports being in fluid communication with an outlet that is in fluid communication with the microcatheter lumen, wherein the second port is connected to the connecting tube.

3. The system of claim 2, wherein the valve includes a first switch having open and closed positions and being mounted at the first port and a second switch having open and closed positions and being mounted at the second port, wherein the second switch controls the blood flow from the connecting tube into the microcatheter lumen.

4. The system of claim 3, wherein the valve has a first configuration where the first switch is closed and the second switch is open to allow blood flow through the flow path and a second configuration where the first switch is open and the second switch is closed to allow supplemental material into the microcatheter lumen through the first port.

5. The system of claim 1, wherein the microcatheter extends beyond the end of the middle catheter.

6. The system of claim 1, wherein the balloon is disposed at the distal end of the microcatheter and disposed distally from the distal end of the middle catheter.

7. The system of claim 1, wherein the introducer sheath covers a portion of the middle catheter, and the middle catheter extends proximally from the proximal portion of the introducer sheath.

8. The system of claim 1 further comprising a middle catheter valve attached at the proximal end of the middle catheter.

9. The system of claim 8, wherein the middle catheter valve includes a first port and a second port, and the microcatheter extends through the first port.

10. The system of claim 9, wherein the second port is in fluid communication with the middle catheter lumen to allow a supplemental material to be introduced into the middle catheter lumen and delivered out of the distal end of the middle catheter.

11. The system of claim 10 further comprising a supplemental tube in fluid communication with the connecting tube and extending between the connecting tube and the second port of the middle catheter valve, and a supplemental stopcock disposed on the supplemental tube between the connecting tube and the second port of the middle catheter valve for controlling flow through the supplemental tube and into the second port of the middle catheter valve.

12. The system of claim 1, wherein the connecting tube includes a stopcock disposed on the connecting tube between the introducer sheath lumen and the second port of the valve for controlling flow through the connecting tube into the second port of the valve.

13. The system of claim 1, wherein the distal end of the introducer sheath includes openings for increasing blood flow into the introducer sheath lumen.

14. The system of claim 11 wherein a second flow path is defined through the supplemental tube, into the second port of the middle catheter valve, into the middle catheter lumen around the microcatheter wall and exiting the distal end of the middle catheter.

15. A method for controlling blood flow, the method comprising:

delivering, to a body lumen, an introducer sheath having a wall defining a longitudinal lumen extending from a proximal portion to a distal end;

advancing, through the lumen of the introducer sheath and out of the distal end thereof, a middle catheter having an outer wall and having a longitudinal opening extending from a proximal portion to a distal end;

advancing, through the lumen of the middle catheter and out of the distal end thereof, a microcatheter having a wall and having a longitudinal lumen extending from a proximal portion to a distal end, the microcatheter having an inflatable balloon on the distal end;

receiving blood into the distal end of the introducer sheath;

advancing the blood into a connecting tube having a first end in fluid communication with the inside of the introducer sheath and a second end in fluid communication with the microcatheter lumen; and

wherein the blood flows through a blood flow path defined between an inner surface of the introducer sheath and an outer surface of the middle catheter, through the connecting tube, through the proximal portion of the microcatheter, through the lumen of the microcatheter, and exiting the microcatheter distal end.

16. The method of claim 15, wherein the microcatheter includes a valve comprising a first port with a first switch having open and closed positions and a second port with a second switch having open and closed positions, the first and second ports are in fluid communication with the microcatheter lumen, and the second port is in fluid communication with the connecting tube.

17. The method of claim 16 further comprising closing the first switch and opening the second switch to allow blood to flow through the flow path.

18. The method of claim 16 further comprising opening the first switch and closing the second switch to prevent blood from flowing through the flow path, and introducing embolic material into the microcatheter lumen via the first port.

19. The method of claim 15, wherein the middle catheter includes a middle catheter valve attached at the proximal portion thereof, the middle catheter valve includes a first port and second port each being in fluid communication with the middle catheter lumen, and the microcatheter extends through the first port into the microcatheter lumen.

20. The method of claim 19, wherein the flow path includes a supplemental tube connected to the second port of the middle catheter valve and extending therefrom to the flow path, wherein the flow path is in fluid communication with the second port of the middle catheter valve, the method further comprising advancing blood through the supplemental tube and into the second port of the middle catheter and into the middle catheter lumen.