# US 10,869,956 B2 · Interventional catheters incorporating aspiration and/or infusion systems

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- Number: US 10,869,956 B2
- Document ID: US10869956B2
- Status: Granted
- Kind: B2
- Application number: 16/001,722
- Filed: 2018-06-06
- Published: 2018-10-04
- Granted: 2020-12-22
- Earliest claimed: 2006-10-04
- Assignees: Boston Scientific Corporation
- Applicants: Boston Scientific Limited
- Inventors: Casey Torrance; Kate Walsh; Jared Salstrom; Scott Youmans; Edward I. Wulfman
- Web page: https://patentgrep.com/patent/US10869956B2

## CPC

- 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)}
- A61B 1/00087: {Tools (A61B17/00234 takes precedence)}
- A61B 1/05: characterised by the image sensor, e.g. camera, being in the distal end portion
- A61B 8/12: in body cavities or body tracts, e.g. by using catheters
- A61B 8/445: {Details of catheter construction}
- A61B 17/32002: {with continuously rotating, oscillating or reciprocating cutting instruments}
- A61B 17/320725: {with radially expandable cutting or abrading elements (A61B17/32075 takes precedence)}
- 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)}
- A61M 1/71: {Suction drainage systems (containers therefor A61M1/60, A61M1/64; negative pressure wound therapy systems A61M1/90)}
- A61M 1/80: {Suction pumps (A61M1/64, A61M1/71, A61M60/00 take precedence)}
- A61M 1/84: {Drainage tubes; Aspiration tips (for negative pressure wound therapy A61M1/90; for surgical cutting instruments A61B17/32)}
- A61M 5/142: Pressure infusion, e.g. using pumps
- 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)}
- A61M 25/0082: {Catheter tip comprising a tool}
- A61M 25/09: Guide wires
- A61B 2017/22079: {with suction of debris}
- A61B 2017/320004: {abrasive}
- A61B 2017/320032: {Details of the rotating or oscillating shaft, e.g. using a flexible shaft}
- A61B 2017/320775: {Morcellators, impeller or propeller like means}
- A61B 2217/005: with suction drainage system
- A61B 2217/007: with irrigation system
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## 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. The catheter assembly may also include at least one liquid infusion port that communicates with a second sealed lumen for supplying fluid to a location in proximity to the target site. Kits including the interventional catheter assembly with an aspiration and/or infusion conduit are also provided.

## Claims

### Claim 1

An interventional catheter assembly comprising:
an operating head mounted at a distal end of a catheter assembly configured for removing obstructive material from a target site in a body lumen or a cavity;
an infusion pump operably connected to a fluid infusion system for delivery of an infusate fluid through the catheter assembly to the target site in the body lumen or cavity;
a detector for detecting a presence of a bubble in the infusate fluid; and
a control module operatively connected to the infusion pump and the operating head;
wherein upon detection of a bubble in the infusate fluid, the control module inactivates the infusion pump;
wherein upon detection of the presence of a bubble in the infusate fluid, the control module inactivates the operating head.

### Claim 2 (depends on 1)

The interventional catheter assembly of claim 1, wherein the control module automatically activates the fluid infusion system upon activation of the operating head.

### Claim 3 (depends on 1)

The interventional catheter assembly of claim 1, additionally comprising at least one override control that allows an operator to override a pre-programmed infusion feature.

### Claim 4 (depends on 1)

The interventional catheter assembly of claim 1, wherein a pressure of the infusate fluid as measured at the infusion pump is about 80 to 200 psi.

### Claim 5 (depends on 1)

The interventional catheter assembly of claim 1, further comprising an aspiration pump operably connected to a fluid aspiration system for aspiration of fluid in proximity to the operating head.

### Claim 6 (depends on 5)

The interventional catheter assembly of claim 5, wherein the control module automatically activates the fluid aspiration system and the fluid infusion system upon activation of the operating head.

### Claim 7 (depends on 5)

The interventional catheter assembly of claim 5, wherein the control module automatically inactivates the fluid aspiration system and the fluid infusion system after a selected time period following inactivation of the operating head.

### Claim 8 (depends on 5)

The interventional catheter assembly of claim 5, further comprising an infusion port for supplying infusate fluid to a location in proximity to the target site.

### Claim 9 (depends on 8)

The interventional catheter assembly of claim 8, further comprising an aspiration port in proximity to the operating head for aspirating fluids and obstructive material from the target site.

### Claim 10 (depends on 9)

The interventional catheter assembly of claim 9, wherein the aspiration port is located proximal to the operating head.

### Claim 11 (depends on 10)

The interventional catheter assembly of claim 10, wherein the infusion port is located proximal of the aspiration port.

### Claim 12

An interventional catheter assembly comprising:
an operating head mounted at a distal end of a catheter assembly configured for removing obstructive material from a target site in a body lumen or a cavity;
an infusion pump operably connected to a fluid infusion system for delivery of an infusate fluid through the catheter assembly to the target site in the body lumen or cavity;
a detector for detecting a presence of a bubble in the infusate fluid; and
a control module operatively connected to the infusion pump and the operating head;
wherein upon detection of a bubble in the infusate fluid, the control module inactivates the infusion pump;
wherein the control module automatically inactivates the fluid infusion system after a selected time period following inactivation of the operating head.

### Claim 13 (depends on 12)

The interventional catheter assembly of claim 12, wherein upon detection of the presence of a bubble in the infusate fluid, the control module inactivates the operating head.

### Claim 14

An interventional catheter system, comprising:
an operating head mounted at a distal end of a catheter assembly configured for removing obstructive material from a target site in a body lumen or a cavity;
an aspiration system including an aspiration pump for applying vacuum to an aspiration port disposed proximate the operating head;
an infusion system including an infusion pump for delivery of an infusate fluid through the catheter assembly to a target site in a body lumen or cavity through an infusion port disposed proximal of the aspiration port, wherein the aspiration port is located proximal to the operating head; and
a detector disposed in proximity to an infusate conduit for detecting a presence of a bubble in the infusate fluid;
wherein upon detection of the presence of the bubble in the infusate fluid, a control module inactivates the aspiration system and the infusion system.

### Claim 15 (depends on 14)

The interventional catheter system of claim 14, wherein upon detection of the presence of the bubble in the infusate fluid, the control module inactivates the operating head.

### Claim 16 (depends on 14)

The interventional catheter system of claim 14, wherein the control module automatically activates the infusion system upon activation of the operating head.

### Claim 17 (depends on 14)

The interventional catheter system of claim 14, wherein the control module automatically activates the aspiration system upon activation of the operating head.

### Claim 18 (depends on 14)

The interventional catheter system of claim 14, wherein the control module automatically activates the infusion system and the aspiration system after a predetermined period of time following activation of the operating head.

### Claim 19 (depends on 14)

The interventional catheter system of claim 14, wherein the control module automatically inactivates the infusion system and the aspiration system after a predetermined period of time following inactivation of the operating head.
