Interventional catheters incorporating aspiration and/or infusion systems

• US 8,657,785 B2
• Filed: 11/30/2010
• Issued: 02/25/2014
• Est. Priority Date: 10/04/2006
• Status: Active Grant

• Current Assignee: Boston Scientific Medical Device Limited (Boston Scientific Corporation)
• Original Assignee: Bayer Medical Care Inc. (Bayer AG)
• Inventors: Torrance, Casey, Walsh, Kate, Salstrom, Jared, Youmans, Scott, Wulfman, Edward I.
• Primary Examiner(s): Stigell, Theodore
• Assistant Examiner(s): Eisenberg, Rebecca E
• Application Number:
  US12/957,236
• Publication Number:
  US 20110071440A1
• Time in Patent Office: 1,183 Days
• Field of Search: 604/118, 604/123, 604170-171, 604/173, 604/151, 604/159, 604/180
• 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 flexible catheter having an integrated infusion lumen and an integrated aspiration lumen configured for insertion and guidance through a blood vessel lumen to a target site in a body;

(b) an operating head mounted in proximity to a distal end of the catheter and comprising a system for removing unwanted material from a target site in a blood vessel lumen or cavity;

(c) at least one aspiration port located proximal to the operating head, wherein the at least one aspiration port extends over at least a portion of a circumference of the catheter and is in communication with the aspiration lumen for withdrawing fluids and unwanted materials from the target site; and

(d) at least one liquid infusion port provided in proximity to the operating head, wherein the at least one infusion port is in communication with the infusion lumen for infusing liquid through the infusion port.

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, comprising a plurality of liquid infusion ports positioned proximal to the operating head and 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 liquid 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 liquid in at least one desired direction around the circumference of the catheter.

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

an infusion system for providing infusion liquid to the infusion lumen and an aspiration system providing vacuum to the aspiration lumen.

7. The interventional catheter assembly of claim 6, additionally comprising controls for operating the infusion system and the aspiration system to provide volume ratios of infusate liquid to aspirate materials of greater than about 1:

1 during operation of the interventional catheter assembly.

8. The interventional catheter assembly of claim 7, wherein the controls provide volume ratios of infusate liquid to aspirate materials of greater than about 1.5:

1 and less than about 2.5;

1.

9. The interventional catheter assembly of claim 7, additionally providing a control for automatically inactivating the infusion system and the aspiration system after a selected time period following inactivation of the operating head.

10. The interventional catheter assembly of claim 1, wherein at least one infusion port is located proximal to the aspiration port.

11. The interventional catheter assembly of claim 1, wherein at least one infusion port is located distal to the aspiration port.

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

an infusion system for providing infusate fluid to the infusion lumen at a pressure of 80 to 200 psi.

13. The interventional catheter assembly of claim 1, wherein the operating head comprises a rotational cutting device.

14. The interventional catheter assembly of claim 1, wherein the operating head comprises a rotational element having an abrasive surface.

15. The interventional catheter assembly of claim 1, wherein the operating head comprises an ablation device.

16. The interventional catheter assembly of claim 15, wherein the ablation device comprises a plaque excision device, a laser ablation device, or a high frequency ultrasound ablation device.

17. An interventional catheter assembly comprising:

a flexible catheter having an integrated infusion lumen and an integrated aspiration lumen configured for insertion and guidance through a blood vessel lumen to a target site in a body;

an operating head mounted in proximity to a distal end of the catheter, the operating head being operable to remove unwanted material from blood vessel lumens or cavities;

at least one aspiration port located proximal to the operating head, wherein the at least one aspiration port extends over at least a portion of a circumference of the catheter and is in communication with the aspiration lumen for withdrawing fluids and obstructive material from the target site; and

at least one liquid infusion port provided in proximity to the operating head, wherein the at least one infusion port is in communication with the infusion lumen for infusing liquid through the infusion port, whereby the interventional catheter assembly, when the aspiration lumen is in operable communication with an aspiration system and the infusion lumen is in operable communication with an infusion system, is capable of operating to provide an infusion rate of about 45-150 ml/min and an aspiration rate of about 20-90 ml/min.

18. An interventional catheter assembly comprising:

a flexible catheter having an integrated infusion lumen and an integrated aspiration lumen configured for insertion and guidance through a blood vessel lumen to a target site in a body;

an operating head mounted in proximity to a distal end of the catheter, the operating head being operable to remove unwanted material from blood vessel lumens or cavities;

at least one aspiration port located proximal to the operating head, wherein the at least one aspiration port extends over at least a portion of a circumference of the catheter and is in communication with the aspiration lumen for withdrawing fluids and obstructive material from the target site; and

at least one liquid infusion port provided in proximity to the operating head, wherein the at least one infusion port is in communication with the infusion lumen for infusing liquid through the infusion port, whereby the interventional catheter assembly, when the aspiration lumen is in operable communication with an aspiration system and the infusion lumen is in operable communication with an infusion system, is capable of operating to provide volume ratios of infusate to aspirate of greater than about 1.5;

1.