Interventional catheters incorporating aspiration and/or infusion systems

• US 7,842,009 B2
• Filed: 10/03/2007
• Issued: 11/30/2010
• 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: Youmans, Scott, Walsh, Kate, Salstrom, Jared, Torrance, Casey, Wulfman, Edward I.
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): Eisenberg; Rebecca E
• Application Number:
  US11/866,973
• Publication Number:
  US 20080103446A1
• Time in Patent Office: 1,154 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 comprising a catheter for insertion and guidance to a target site in a body lumen or a cavity and an operating head mounted in proximity to a distal end of the catheter and comprising a system for removing obstructive material from the target site is provided. In certain embodiments, the catheter assembly includes at least one aspiration port located proximal to the operating head that communicates with a first sealed lumen for withdrawing fluids and obstructive material from the target site, together with at least one liquid infusion port penetrating the catheter and located proximal to the at least one aspiration port that communicates with a second sealed lumen for supplying fluid to a location in proximity to the target site.

Claims

1. An interventional catheter assembly comprising:

(a) a catheter for insertion and guidance to a target site in a body;

(b) a rotational operating head mounted in proximity to a distal end of the catheter, the operating head comprising a plurality of external cutter elements for breaking down obstructive material into particles at the target site;

(c) at least one aspiration port located proximal to the operating head and each of the plurality of external cutter elements, wherein the at least one aspiration port extends over at least 20% of a circumference of the catheter and is in communication with a first sealed lumen for withdrawing fluids and obstructive material from the target site; and

(d) a plurality of infusion ports located proximally with respect to the at least one aspiration port and communicating with an infusion lumen in the catheter.

2. The interventional catheter assembly of claim 1, wherein the at least one aspiration port extends over at least 30% of the circumference of the catheter.

3. The interventional catheter assembly of claim 1, additionally comprising an infusion system for supplying infusion fluid to a location in proximity to the target site and a wherein the plurality of liquid infusion ports are spaced circumferentially around the catheter.

4. The interventional catheter assembly of claim 3, wherein the plurality of liquid infusion ports are uniformly spaced around the circumference of the catheter to provide substantially even distribution of infusion fluid around the circumference of the catheter.

5. The interventional catheter assembly of claim 3, wherein the plurality of liquid infusion ports are non-uniformly spaced to direct flow of infusion fluid in at least one desired direction around the circumference of the catheter.

6. The interventional catheter assembly of claim 1, additionally comprising at least one port located in the operating head and in communication with a sealed lumen for aspiration or infusion of liquid.

7. The interventional catheter assembly of claim 1, additionally comprising:

an infusion system for providing infusion fluid, wherein the infusion and aspiration systems are controlled during operation of the interventional catheter assembly to provide volume ratios of infusate to aspirate of greater than about 1;

1 and less than about 2.5;

1.

8. The interventional catheter assembly of claim 7, wherein the volume ratio of infusion fluid to aspirate is greater than about 1.5:

1 and less than about 2.5;

1.

9. The interventional catheter assembly of claim 1, additionally comprising at least one infusion port located proximal to the aspiration port.

10. The interventional catheter assembly of claim 1, additionally comprising:

an infusion system for providing infusion fluid to a location in proximity to the target site, wherein the infusion and aspiration systems are controlled during operation of the interventional catheter assembly to provide an infusion rate of about 45-150 ml/min and an aspiration rate of about 20-90 ml/min.

11. The interventional catheter assembly of claim 1, additionally comprising:

an infusion system for providing infusion fluid to a location in proximity to the target site, wherein the aspiration system and the infusion system are automatically inactivated after a selected time period following inactivation of the operating head.

12. The interventional catheter assembly of claim 1, wherein the cutter elements are fixed cutting blades.

13. The interventional catheter assembly of claim 1, wherein the cutter elements are adjustable cutting blades.

14. The interventional catheter assembly of claim 1, wherein the cutter elements are differential cutting blades.

15. The interventional catheter assembly of claim 1, wherein the operating head additionally comprises an abrasive surface.

16. The interventional catheter assembly of claim 1, wherein the at least one aspiration port is provided as an opening in a substantially rigid cylindrical shell.

17. The interventional catheter assembly of claim 16, wherein the operating head comprises a cutter assembly having a plurality of external cutter elements and the substantially rigid cylindrical shell is approximately the same length as the cutter assembly.

18. The interventional catheter assembly of claim 1, additionally comprising an infusion system providing infusion fluid distal to the operating head.

19. The interventional catheter assembly of claim 1, additionally comprising an infusion system providing infusion fluid proximal to the operating head.

20. The interventional catheter assembly of claim 1, additionally comprising an infusion system having at least one liquid infusion port providing directional flow of infusate.

21. The interventional catheter assembly of claim 1, additionally comprising an infusion system providing infusion fluid at pressures of from about 80 to 200 psi during operation.

22. The interventional catheter assembly of claim 1, wherein the at least one aspiration port is provided in a cylindrical shell structure located proximal to the operating head and each of the plurality of external cutter elements, wherein the cylindrical shell structure forms a stationary element of a bearing at its distal end and remains stationary relative to the operating head during rotation of the operating head.