Endovenous access and guidance system utilizing non-image based ultrasound

• US 20070016072A1
• Filed: 05/08/2006
• Published: 01/18/2007
• Est. Priority Date: 05/06/2005
• Status: Active Grant

• Current Assignee: Teleflex Life Sciences LLC (Teleflex Incorporated)
• Original Assignee: Vasonova, Inc. (Teleflex Incorporated)
• Inventors: Grunwald, Sorin, Hill, Bradley
• Granted Patent: US 9,204,819 B2
• Time in Patent Office: Days
• US Class Current: 600/468
• CPC Class Codes: A61B 2017/00106 ultrasonic
• CPC Class Codes: A61B 2034/2063 Acoustic tracking systems, e.g. using ultrasound
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 5/02 Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
• CPC Class Codes: A61B 5/02152 specially adapted for venous pressure
• CPC Class Codes: A61B 5/06 Devices, other than using radiation, for detecting or locating foreign bodies for removing same A61B17/50 ; determining position of probes within or on the body of the patient
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/7246 using correlation, e.g. template matching or determination of similarity
• CPC Class Codes: A61B 5/7271 Specific aspects of physiological measurement analysis A61B5/316, A61B5/349 and A61B5/374 take precedence
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 8/04 Measuring blood pressure
• CPC Class Codes: A61B 8/06 Measuring blood flow measuring volume flow in general G01F, e.g. G01F1/66, G01F1/72; measuring speed of fluids in general G01P5/00
• CPC Class Codes: A61B 8/0841 for locating instruments
• 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 8/42 Details of probe positioning or probe attachment to the patient
• CPC Class Codes: A61B 8/445 Details of catheter construction
• CPC Class Codes: A61B 8/4472 Wireless probes
• CPC Class Codes: A61B 8/461 Displaying means of special interest
• CPC Class Codes: A61B 8/488 involving Doppler signals
• CPC Class Codes: A61B 8/5207 : involving processing of raw data to produce diagnostic data, e.g. for generating an image reconstruction G06T11/00

Abstract

The invention relates to the guidance, positioning and placement confirmation of intravascular devices, such as catheters, stylets, guidewires and other flexible elongate bodies that are typically inserted percutaneously into the venous or arterial vasculature. Currently these goals are achieved using x-ray imaging and in some cases ultrasound imaging. This invention provides a method to substantially reduce the need for imaging related to placing an intravascular catheter or other device. Reduced imaging needs also reduce the amount of radiation that patients are subjected to, reduce the time required for the procedure, and decrease the cost of the procedure by reducing the time needed in the radiology department. An aspect of the invention includes, for example, an endovenous access and guidance system. The system comprises: an elongate flexible member adapted and configured to access the venous vasculature of a patient; a sensor disposed at a distal end of the elongate flexible member and configured to provide in vivo non-image based ultrasound information of the venous vasculature of the patient; a processor configured to receive and process in vivo non-image based ultrasound information of the venous vasculature of the patient provided by the sensor and to provide position information regarding the position of the distal end of the elongate flexible member within the venous vasculature of the patient; and an output device adapted to output the position information from the processor.

Claims

1. An endovenous access and guidance system, comprising:

an elongate flexible member adapted and configured to access the venous vasculature of a patient;

a sensor disposed at a distal end of the elongate flexible member and configured to provide in vivo non-image based ultrasound information of the venous vasculature of the patient;

a processor configured to receive and process in vivo non-image based ultrasound information of the venous vasculature of the patient provided by the sensor and to provide position information regarding the position of the distal end of the elongate flexible member within the venous vasculature of the patient; and

an output device adapted to output the position information from the processor.

2. The endovenous access and guidance system of claim 1 wherein the elongate flexible member comprises a catheter.

3. The endovenous access and guidance system of claim 1 wherein the elongate flexible member comprises a guide wire.

4. The endovenous access and guidance system of claim 1 wherein the elongate flexible member comprises a stylet.

5. The endovenous access and guidance system of claim 1 wherein the elongate flexible member is adapted to deliver a therapy to the patient.

6. The endovenous access and guidance system of claim 1 wherein the elongate flexible member is adapted to provide endovenous access for another device.

7. The endovenous access and guidance system of claim 1 further comprising a sensor attachment mechanism adapted to removably detach the sensor from the elongate flexible member while the elongate flexible member remains in the vasculature of the patient.

8. The endovenous access and guidance system of claim 1 wherein the processor is further configured to process in vivo non-image based ultrasound information of the vasculature system of the patient provided by the sensor to indicate in the output information the proximity of the sensor to a structure within the vasculature of the patient.

9. The endovenous access and guidance system of claim 1 wherein the processor is further configured to process in vivo non-image based ultrasound information of the vasculature system of the patient to indicate in the output information movement of the elongate flexible member in a desired direction within the vasculature of the patient.

10. The endovenous access and guidance system of claim 1 wherein the processor is further configured to process in vivo non-image based ultrasound information of the vasculature system of the patient based on a parameter selected from a group consisting of:

a venous blood flow direction, a venous blood flow velocity, a venous blood flow signature pattern, a pressure signature pattern, A-mode information and a preferential non-random direction of flow.

11. The endovenous access and guidance system of claim 1 further comprising a divergent lens associated with the sensor.

12. The endovenous access and guidance system of claim 1 further comprising a plurality of lenses associated with the sensor.

13. The endovenous access and guidance system of claim 11 wherein the divergent lens is adapted to attach the sensor to the elongate flexible member.

14. The endovenous access and guidance system of claim 1 wherein the sensor is a first sensor adapted to transmit an ultrasound signal, the system further comprising a second sensor adapted to receive non-image based ultrasound information.

15. The endovenous access and guidance system of claim 1 further comprising a sensor drive mechanism adapted drive the sensor in a plurality of ultrasound transmission modes.

16. The endovenous access and guidance system of claim 1 wherein the sensor is a first sensor, the system further comprising a second sensor disposed at the distal end of the elongate flexible member and configured to provide in vivo non-image based ultrasound information of the venous vasculature of the patient to the processor.

17. The endovenous access and guidance system of claim 1 further comprising a centering element adapted to substantially center the distal end of the elongate member within a vessel.

18. The endovenous access and guidance system of claim 1 further comprising two or more additional sensors wherein the sensor and the two or more additional sensors are attached to the elongate flexible member in an arrangement that mimics an endovascular junction.

19. The endovenous access and guidance system of claim 1 further comprising a steering element for directing the device tip in response to feedback information derived from the acquired data.

20. The endovenous access and guidance system of claim 1 further comprising a torque control element for directing the device tip in response to feedback information derived from the acquired data.