Apparatus and method for vascular access

• US 10,368,837 B2
• Filed: 04/06/2016
• Issued: 08/06/2019
• Est. Priority Date: 05/06/2005
• Status: Active Grant

• Current Assignee: Teleflex Life Sciences LLC (Teleflex Incorporated)
• Original Assignee: Arrow International Incorporated (Teleflex Incorporated)
• Inventors: Grunwald, Sorin, Sander, Fiona Maria, Samson, Wilfred J., Hill, Bradley
• Primary Examiner(s): Turchen, Rochelle D
• Application Number:
  US15/092,588
• Publication Number:
  US 20160220226A1
• Time in Patent Office: 1,217 Days
• CPC Class Codes: A61B 2017/00106 ultrasonic
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 2090/3782 transmitter or receiver in catheter or minimal invasive instrument
• CPC Class Codes: A61B 2090/3929 Active markers
• 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 5/06 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 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: A61B 7/00 Instruments for auscultation
• 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 8/461 Displaying means of special interest
• CPC Class Codes: A61B 90/11 with guides for needles or instruments, e.g. arcuate slides or ball joints
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture

Abstract

In an aspect, embodiments of the invention relate to the effective and accurate placement of intravascular devices such as central venous catheters, in particular such as peripherally inserted central catheters or PICC. One aspect of the present invention relates to vascular access. It describes devices and methods for imaging guided vascular access and more effective sterile packaging and handling of such devices. A second aspect of the present invention relates to the guidance, positioning and placement confirmation of intravascular devices without the help of X-ray imaging. A third aspect of the present invention relates to devices and methods for the skin securement of intravascular devices and post-placement verification of location of such devices. A forth aspect of the present invention relates to improvement of the workflow required for the placement of intravascular devices.

Claims

1. An endovascular device, comprising:

a torquable elongate body sized for insertion into the vasculature, the torquable elongate body having a proximal end and a distal end terminating in a distal tip;

a sensor on the distal end of the torquable elongate body, the sensor configured to measure a characteristic of blood flow within a blood vessel;

a structure on or in the torquable elongate body that is configured to radially expand to move the distal tip of the torquable elongate body away from a peripheral inner surface of the blood vessel while maintaining blood flow within the blood vessel when the structure is radially expanded within the blood vessel; and

a signal processor connected to the sensor and the structure, the signal processor being configured to;

receive the measured characteristic of blood flow within the blood vessel,

determine that the sensor is within a minimum lateral distance from the peripheral inner surface when the peripheral inner surface is peripheral of the sensor based on the measured characteristic of blood flow within the blood vessel, and

cause active manipulation of the structure to move the distal tip of the torquable elongate body laterally away from the peripheral inner surface of the blood vessel to the minimum lateral distance to avoid measuring the characteristic of blood flow at a periphery of the blood vessel.

2. The device of claim 1, wherein the torquable elongate body further comprises a distal segment that is flexible and made of a polymer, and the polymer being reinforced to increase tensile strength.

3. The device of claim 1, wherein the structure is a star shaped balloon on or about the torquable elongate body.

4. The device of claim 1, wherein the structure is a deployable circular braid.

5. The device of claim 1, wherein the structure is a deployable balloon.

6. The device of claim 1, wherein the structure comprises strips cut in the torquable elongate body that are radially expanded.

7. The device of claim 1, wherein the structure comprises a deployable basket.

8. The device of claim 1, wherein the signal processor is configured to cause active manipulation of the torquable elongate body within the blood vessel to align the sensor with the blood flow.

9. The device of claim 1, wherein the structure comprises a tether component attached to the torquable elongate body.

10. The device of claim 1, wherein the sensor is an ultrasound transducer.

11. The device of claim 10, wherein the ultrasound transducer is a pulsed wave Doppler or continuous wave Doppler sensor.

12. The device of claim 2, wherein the polymer is reinforced with a coil within the polymer of the torquable elongate body.

13. The device of claim 1, wherein the distal end of the torquable elongate body is closed and defines side ports for fluid delivery.

14. The device of claim 1, wherein the sensor is distal to the structure on or in the torquable elongate body.

15. The device of claim 1, wherein the sensor is within the structure on or in the torquable elongate body.

16. The device of claim 1, wherein proximal end of the torquable elongate body is made of a stiffer material than the distal end of the torquable elongate body.

17. The device of claim 1, wherein the structure is radially offset about the torquable elongate body.

18. The device of claim 1, wherein the measured characteristic of blood flow within the blood vessel comprises velocity of blood flow within the blood vessel.

19. The device of claim 18, wherein the measured characteristic of blood flow within the blood vessel further comprises pulsatility pattern of blood flow within the blood vessel.