Granted Patent B2

US 12,661,187 · App. 18/458,358 · Granted Jun 23, 2026

Inventors: Fletcher T. Wilson (San Francisco, CA); Michi E. Garrison (Half Moon Bay, CA); Kent D. Dell (Redwood City, CA); Herbert Mendoza (South San Francisco, CA); Benjamin J. Clark (Redwood City, CA); Emmanuelle F. Pease (San Francisco, CA)

Assignee: INTERVENE, INC.

A61B34/20A61B8/12A61B8/4254A61B8/445A61B17/00234A61M25/0082A61M25/0136A61M25/003A61M2025/0166

Abstract

Claims (53)

1 . A method for forming an autologous valve leaflet in a vessel wall, the method comprising:

intravascularly advancing a distal end portion of a vessel access device to a target site within a vessel, wherein the distal end portion comprises a trough section and an exit port positioned proximal to and aligned with the trough section;

deploying a needle distally through the exit port such that the needle moves in a direction aligned with a longitudinal axis of the trough section;

positionally coupling an imaging transducer to the needle such that the imaging transducer and the needle move in tandem;

while the imaging transducer is coupled to the needle, advancing the needle distally with respect to the exit port of the vessel access device and at least partially into the vessel wall at a location aligned with the trough section of the vessel access device along an axis orthogonal to the longitudinal axis, wherein the needle advances independently from the vessel access device;

determining a position of the needle relative to the imaging transducer while advancing the needle after at least partially into the vessel wall;

obtaining images from the imaging transducer while advancing the needle to visualize the vessel wall during needle penetration;

positionally coupling the imaging transducer to a second component such that the imaging transducer and the second component move in tandem;

while the imaging transducer is coupled to the second component, advancing the second component distally with respect to the exit port of the vessel access device and at least partially into the vessel wall at a location aligned with the trough section of the vessel access device along an axis orthogonal to the longitudinal axis, wherein the second component advances independently from the vessel access device and the needle; and

obtaining images from the imaging transducer while advancing the second component to visualize the vessel wall during dissection.

2 . The method of claim 1 , wherein:

the imaging transducer is movable within a transducer lumen of a catheter shaft of the vessel access device such that the imaging transducer moves relative to the longitudinal axis of the trough section; and

coupling the imaging transducer to the needle comprises aligning the imaging transducer with a distal tip of the needle.

3 . The method of claim 1 , further comprising detecting a position of the imaging transducer relative to a distal terminus of the vessel access device.

4 . The method of claim 1 wherein the imaging transducer is a first imaging transducer, wherein the distal end portion further comprises multiple second imaging transducers affixed along the trough section of the vessel access device, and wherein the method further comprises activating one of the multiple second imaging transducers based on a position of the needle relative to the multiple second imaging transducers.

5 . The method of claim 1 , further comprising decoupling the imaging transducer from the needle such that the imaging transducer and the needle move relative to each other.

6 . The method of claim 1 , further comprising:

advancing a tissue dissection component distally to access a space in the vessel wall through an opening created by the needle; and

obtaining images from the imaging transducer while dissecting the vessel wall with the tissue dissection component to visualize the vessel wall during dissection.

7 . The method of claim 6 , further comprising:

before advancing the tissue dissection component distally to access the space in the vessel wall, positionally coupling the imaging transducer to the tissue dissection component.

8 . The method of claim 1 , further comprising determining a position of a distal end of the needle relative to the distal end portion of the vessel access device after at least partially penetrating the vessel wall.

9 . The method of claim 1 , further comprising determining a position of the imaging transducer relative to a distalmost end of the trough section while advancing the needle at least partially into the vessel wall.

10 . A method for imaging intravascular operations of a catheter device, the method comprising:

intravascularly advancing a distal end portion of a catheter shaft adjacent to a target location in a vessel, wherein the distal end portion comprises a trough section and an exit port positioned to direct tools into the trough section;

positionally coupling an imaging transducer to a first component;

advancing the first component through the exit port and into the trough section while the imaging transducer is positionally coupled to the first component;

obtaining images from the imaging transducer while advancing the first component to visualize operations of the first component;

positionally coupling the imaging transducer to a second component such that the imaging transducer and the second component move in tandem;

advancing the second component through the exit port and into the trough section while the imaging transducer is positionally coupled to the second component; and

obtaining images from the imaging transducer while advancing the second component to visualize the operations of the second component.

11 . The method of claim 10 wherein the imaging transducer is movable along a longitudinal axis of the distal end portion and configurable between at least a first state and a second state, wherein:

in the first state, the imaging transducer is positionally coupled to the first component;

in the second state, the imaging transducer can move along the longitudinal axis independently from the first component; and

positionally coupling the imaging transducer to the first component comprises transitioning the imaging transducer from the second state to the first state.

12 . The method of claim 10 wherein the first component is configured to puncture a vessel wall at the target location, and wherein the second component is configured to access the vessel wall over the first component.

13 . The method of claim 12 wherein:

the imaging transducer is a first imaging transducer, wherein the second component includes one or more second imaging transducers; and

the method further comprises obtaining images from the one or more second imaging transducers while accessing the vessel wall to visualize a space in the vessel wall.

14 . The method of claim 12 wherein:

the imaging transducer is a first imaging transducer;

the first component includes one or more second imaging transducers; and

the method further comprises obtaining images from the one or more second imaging transducers while visualize a space in the vessel wall.

15 . A method for imaging a vessel wall during a dissection of the vessel wall, the method comprising:

positioning an end effector assembly adjacent to a target region of the vessel wall, wherein the end effector assembly comprises an exit port positioned to direct a tissue access component and a tissue dissection component toward a vessel wall when the end effector assembly is adjacent to the target region;

positionally coupling an imaging transducer to the tissue access component such that the imaging transducer advances within a transducer lumen at the end effector assembly simultaneously with the tissue access component advancing through the exit port;

advancing the imaging transducer within the transducer lumen while the tissue access component advances through the exit port and into the vessel wall;

obtaining images from the imaging transducer while advancing the imaging transducer to visualize the vessel wall while the tissue access component creates a space in the vessel wall;

positionally coupling the imaging transducer to the tissue dissection component such that the imaging transducer advances simultaneously with the tissue dissection component;

advancing the imaging transducer within the transducer lumen while the tissue dissection component advances through the exit port and into the space in the vessel wall; and

obtaining images from the imaging transducer while advancing the imaging transducer to visualize the vessel wall during the dissection.

16 . The method of claim 15 , further comprising obtaining images of the vessel wall from the imaging transducer while positioning the end effector assembly to visualize the target region in the vessel wall.

17 . The method of claim 15 wherein the tissue dissection component is configured to slide concentrically over the tissue access component, and wherein the method further comprises advancing the tissue dissection component concentrically over the tissue access component to position the tissue dissection component within the space in the vessel wall.

Assignments (1)

Continuity (3)

References Cited (222)