# US 10,368,837 B2 · Apparatus and method for vascular access

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- Number: US 10,368,837 B2
- Document ID: US10368837B2
- Status: Granted
- Kind: B2
- Application number: 15/092,588
- Filed: 2016-04-06
- Published: 2016-08-04
- Granted: 2019-08-06
- Earliest claimed: 2005-05-06
- Assignees: Arrow International, Inc.
- Applicants: Arrow International, Inc.
- Inventors: Sorin Grunwald; Fiona Maria Sander; Wilfred J. Samson; Bradley Hill
- Web page: https://patentgrep.com/patent/US10368837B2

## CPC

- A61B 8/12: in body cavities or body tracts, e.g. by using catheters
- A61B 5/06: Devices, other than using radiation, for detecting or locating foreign bodies {; Determining position of diagnostic devices within or on the body of the patient}
- A61B 5/411: {Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance}
- A61B 7/00: Instruments for auscultation
- A61B 8/06: Measuring blood flow
- A61B 8/0841: {for locating instruments}
- A61B 8/42: {Details of probe positioning or probe attachment to the patient}
- A61B 8/445: {Details of catheter construction}
- A61B 90/11: with guides for needles or instruments, e.g. arcuate slides or ball joints
- G16H 20/40: relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
- A61B 5/1459: invasive, e.g. introduced into the body by a catheter
- A61B 8/461: {Displaying means of special interest}
- A61B 34/20: Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
- A61B 2017/00106: {ultrasonic}
- A61B 2017/003: {Steerable}
- A61B 2090/378: {using ultrasound}
- A61B 2090/3782: {transmitter or receiver in catheter or minimal invasive instrument}
- A61B 2090/3929: {Active markers}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## 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

### Claim 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.

### Claim 2 (depends on 1)

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.

### Claim 3 (depends on 1)

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

### Claim 4 (depends on 1)

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

### Claim 5 (depends on 1)

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

### Claim 6 (depends on 1)

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

### Claim 7 (depends on 1)

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

### Claim 8 (depends on 1)

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.

### Claim 9 (depends on 1)

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

### Claim 10 (depends on 1)

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

### Claim 11 (depends on 10)

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

### Claim 12 (depends on 2)

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

### Claim 13 (depends on 1)

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

### Claim 14 (depends on 1)

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

### Claim 15 (depends on 1)

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

### Claim 16 (depends on 1)

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.

### Claim 17 (depends on 1)

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

### Claim 18 (depends on 1)

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.

### Claim 19 (depends on 18)

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.
