Interventional catheters incorporating an active aspiration system

• US 7,713,235 B2
• Filed: 10/03/2007
• Issued: 05/11/2010
• Est. Priority Date: 10/04/2006
• Status: Active Grant

• Current Assignee: Boston Scientific Medical Device Limited (Boston Scientific Corporation)
• Original Assignee: Pathway Medical Technologies, Inc. (Bayer AG)
• Inventors: Auth, David, Torrance, Casey
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): Eisenberg; Rebecca E
• Application Number:
  US11/866,975
• Publication Number:
  US 20080103439A1
• Time in Patent Office: 951 Days
• Field of Search: 604/118, 604/123, 604/151, 604/173, 606127-128, 606/159, 606170-171, 606/180
• US Class Current: 604/118
• CPC Class Codes: A61B 1/00087 Tools A61B17/00234 takes precedence
• CPC Class Codes: A61B 1/05 characterised by the image sensor, e.g. camera, being in the distal end portion
• CPC Class Codes: A61B 17/32002 with continuously rotating, oscillating or reciprocating cutting instruments
• CPC Class Codes: A61B 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 2017/22079 with suction of debris
• CPC Class Codes: A61B 2017/320004 abrasive
• CPC Class Codes: A61B 2017/320032 Details of the rotating or oscillating shaft, e.g. using a flexible shaft
• CPC Class Codes: A61B 2017/320775 Morcellators, impeller or propeller like means
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61B 2217/007 with irrigation system
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/445 Details of catheter construction
• CPC Class Codes: A61M 1/71 Suction drainage systems containers therefor A61M1/60, A61M1/64; negative pressure wound therapy systems A61M1/90
• CPC Class Codes: A61M 1/80 Suction pumps A61M1/64, A61M1/71, A61M60/00 take precedence
• CPC Class Codes: A61M 1/84 Drainage tubes; Aspiration tips for negative pressure wound therapy A61M1/90; for surgical cutting instruments A61B17/32
• CPC Class Codes: A61M 25/0082 Catheter tip comprising a tool
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• CPC Class Codes: A61M 5/16831 : Monitoring, detecting, signalling or eliminating infusion flow anomalies low-level float-valves causing cut-off A61M5/40; indicating or recording presence, absence or direction of flow in general G01P13/0066

Abstract

An interventional catheter assembly comprises an operating head for removing obstructive material from a target site in a body lumen or cavity and at least one aspiration port located proximal to the operating head and penetrating the catheter assembly, the aspiration port being in communication with a sealed lumen that communicates with a vacuum system for withdrawing aspirate fluid and obstructive material from the target site. A rotatable member is positioned inside the catheter assembly at the site of the aspiration port and rotates during operation of the vacuum system. The rotatable member is provided with at least one upstanding bar that is sized to cooperate with the walls of the aspiration port and the inner surface of the catheter assembly to macerate debris that is drawn into the aspiration port.

Claims

1. An interventional catheter assembly comprising:

(a) an operating head mounted at a distal end of the catheter assembly and comprising a system for removing obstructive material from a target site in a body lumen or cavity;

(b) at least one aspiration port located proximal to the operating head and penetrating the catheter assembly, the at least one aspiration port being in communication with a first sealed lumen that communicates with a vacuum system for withdrawing aspirate fluid and obstructive material from the target site; and

(c) a rotatable member positioned within an internal cavity of the catheter assembly at the site of the aspiration port, wherein the rotatable member comprises at least one upstanding bar provided on a rotatable drive element, the at least one upstanding bar having a longitudinal axis that is aligned with a longitudinal axis of the catheter assembly, wherein the at least one upstanding bar does not extend radially beyond an inner wall of the catheter assembly and the rotatable member rotates during operation of the vacuum system.

2. The interventional catheter assembly of claim 1, wherein The rotatable member is provided on a common central axis with the catheter assembly at the site of the aspiration port.

3. The interventional catheter assembly of claim 1, wherein the aspiration port extends over at least 15% of the circumference of the catheter assembly.

4. The interventional catheter assembly of claim 1, wherein the at least one upstanding bar is sized to interact with at least one wall of the aspiration port and an inner surface of the catheter assembly to macerate obstructive material that is drawn into the aspiration port.

5. The interventional catheter assembly of claim 1, wherein the rotatable member comprises at least two upstanding bars provided in a radially symmetrical arrangement with respect to the longitudinal axis of the catheter assembly.

6. The interventional catheter assembly of claim 1, wherein the at least one upstanding bar is provided on a central core structure and has a higher profile with respect to an outer surface of the central core structure at its proximal end than at its distal end.

7. The interventional catheter assembly of claim 1, wherein the at least one upstanding bar is provided with undercut walls that facilitate movement of aspirate fluid and obstructive material proximally to the aspiration lumen.

8. The interventional catheter assembly of claim 7, wherein the undercut walls are at an angle of from about 10°

to about 60°

with respect to a line bisecting the upstanding bar and intersecting a central longitudinal axis of the rotatable member.

9. The interventional catheter assembly of claim 1, further comprising at least one infusion port located proximally to the aspiration port and communicating with a second sealed lumen for the infusion of fluids.

10. The interventional catheter assembly of claim 1, further comprising multiple infusion ports spaced radially on an outer circumference of the catheter assembly.

11. The interventional catheter assembly of claim 10, wherein the multiple infusion ports are located proximally to the aspiration port.

12. The interventional catheter assembly of claim 1, wherein the aspiration port extends over at least 25% of the circumference of the catheter assembly.

13. The interventional catheter assembly of claim 1, wherein the aspiration port extends over at least 35% of the circumference of the catheter assembly.

14. The interventional catheter assembly of claim 1, further comprising at least one infusion port located within the operating head.

15. The interventional catheter assembly of claim 1, wherein the operating head comprises a differential cutter assembly.

16. An interventional catheter assembly comprising:

(a) an operating head mounted at a distal end of the catheter assembly and comprising a system for removing obstructive material from a target site in a body lumen or cavity;

(b) at least one aspiration port located proximal to the operating head and penetrating the catheter assembly, the at least one aspiration port being in communication with a first sealed lumen that communicates with a vacuum system for withdrawing aspirate fluid and obstructive material from the target site; and

(c) a rotatable member positioned within an internal cavity of the catheter assembly at the site of the aspiration port, wherein the rotatable member rotates during operation of the vacuum system and comprises at least one upstanding bar provided on a rotatable drive element, wherein the at least one upstanding bar does not extend radially beyond an inner wall of the catheter assembly, has a curved exterior surface that generally matches an interior surface of the internal cavity of the catheter assembly and rotates within the internal cavity.

17. The interventional catheter assembly of claim 16, wherein the at least one upstanding bar has a longitudinal axis that is aligned with a longitudinal axis of the catheter assembly.

18. The interventional catheter assembly of claim 16, further comprising at least one infusion port located proximally to the aspiration port and communicating with a second sealed lumen for the infusion of fluids.

19. The interventional catheter assembly of claim 16, further comprising multiple infusion ports spaced radially on an outer circumference of the catheter assembly.

20. The interventional catheter assembly of claim 19, wherein the multiple infusion ports are located proximally to the aspiration port.

21. The interventional catheter assembly of claim 19, further comprising at least one infusion port located within the operating head.

22. The interventional catheter assembly of claim 19, wherein the operating head comprises a differential cutter assembly.

23. An interventional catheter assembly comprising:

(a) an operating head mounted at a distal end of the catheter assembly and comprising a system for removing obstructive material from a target site in a body lumen or cavity;

(b) at least one aspiration port provided as an opening in a cylindrical shell structure located proximal to the operating head, the at least one aspiration port being in communication with a first sealed lumen that communicates with a vacuum system for withdrawing aspirate fluid and obstructive material from the target site; and

(c) a rotatable member that is enclosed by and rotates within the cylindrical shell structure during operation of the vacuum system, wherein the rotatable member comprises at least one upstanding bar.

24. The interventional catheter assembly of claim 23, wherein the at least one upstanding bar has a longitudinal axis that is aligned with a longitudinal axis of the catheter assembly.

25. The interventional catheter assembly of claim 23, wherein the at least one upstanding bar has a tapered structure, with a narrower profile toward a proximal end of the internal cavity.

26. The interventional catheter assembly of claim 23, wherein side walls of the at least one upstanding bar have different dimensions along the length of the upstanding bar.

27. The interventional catheter assembly of claim 23, wherein side walls of the at least one upstanding bar have different undercut angles along the length of the upstanding bar.

28. The interventional catheter assembly of claim 23, wherein the cylindrical shell structure remains static during rotation of the rotatable member.

29. The interventional catheter assembly of claim 23, further comprising at least one infusion port located proximally to the aspiration pod and communicating with a second sealed lumen for the infusion of fluids.

30. The interventional catheter assembly of claim 23, further comprising multiple infusion ports spaced radially on an outer circumference of the catheter assembly.

31. The interventional catheter assembly of claim 30, wherein the multiple infusion ports are located proximally to the aspiration port.

32. The interventional catheter assembly of claim 23, further comprising at least one infusion port located within the operating head.

33. The interventional catheter assembly of claim 23, wherein the operating head is rotatable and incorporates cutter elements.

34. The interventional catheter assembly of claim 23, wherein the operating head comprises an abrasive material.

35. The interventional catheter assembly of claim 23, wherein the operating head comprises a differential cutter assembly.