IP Library › Granted Patent US 12,708,438
Granted Patent B2
US 12,708,438 · App. 18/899,694 · Granted Aug 18, 2026

Shunting catheters and methods for tissual removal

Inventors: Rani Abdullah Mahmoudi (Costa Mesa, CA); Ajay Kumar Dass (Costa Mesa, CA); Wei Gan (Irvine, CA)
Assignee: Theraheart Inc.
A61B18/1492A61B2017/00247A61B2017/320064A61B17/32053A61B2018/00601A61B2217/005
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Quick Facts
Patent No.
US 12,708,438
App. No.
18/899,694
Filed
Sep 27, 2024
Granted
Aug 18, 2026
Kind
B2
Examiner
OUYANG, BO
Art Unit
3794
USPC
606/46
Abstract

At least some embodiments of the present disclosure are directed to systems and methods for creating a shunt in a patient. In some embodiments, a shunting catheter includes a catheter shaft including a shaft lumen and a side opening, and a tissue-removal assembly disposed in the shaft lumen in a first state and including a shunting shaft being extendable from the side opening of the catheter shaft. In some examples, the shunting shaft has a curved shape when extending from the side opening to a second state. In some examples, the tissue-removal assembly includes a cutting component disposed at a distal end of the shunting shaft.

Claims (66)

1 . A shunting catheter, comprising:

a catheter shaft including a shaft lumen and a side opening; and

a tissue-removal assembly disposed in the shaft lumen in a first state and comprising a shunting shaft being extendable from the side opening of the catheter shaft, the shunting shaft having a curved shape when extending from the side opening to a second state, the shunting shaft having an opening at a distal end thereof;

wherein the shunting shaft comprises a cutting component disposed at the distal end of the shunting shaft;

wherein the cutting component extends along a circumferential direction of the opening at the distal end of the shunting shaft,

wherein the tissue-removal assembly further comprises:

a puncture element being extendable from the distal end of the shunting shaft; and

a puncture element shaft connecting the puncture element to the distal end of the shunting shaft, the puncture element shaft configured to mechanically support the puncture element when the puncture element is extended from the shunting shaft at an extended state; and

wherein:

the puncture element includes a rear surface that is coupled to the puncture element shaft;

the rear surface of the puncture element has a first diameter;

the puncture element shaft has a second diameter; and

the first diameter is greater than the second diameter.

2 . The shunting catheter of claim 1 , wherein the cutting component comprises an ablation electrode or a mechanical cutting member.

3 . The shunting catheter of claim 1 , wherein the cutting component has a ring shape.

4 . The shunting catheter of claim 1 , wherein:

the puncture element shaft is configured to extend the puncture element at a first distance at the extended state and at a second distance at a retracted state, wherein the first distance is greater than the second distance.

5 . The shunting catheter of claim 1 , wherein the puncture element further comprises a puncturing tip at a distal portion, wherein the puncturing tip includes an electrode to deliver a radiofrequency (RF) ablation or a mechanical puncturing tip.

6 . The shunting catheter of claim 1 , wherein the puncture element has a curved cone shape.

7 . The shunting catheter of claim 1 , wherein the puncture element further comprises an array of tissue capturing structures, each tissue capturing structure of the array of tissue capturing structures having a first end disposed at a surface of the puncture element and a second end extended from the surface of the puncture element.

8 . The shunting catheter of claim 1 , wherein the puncture element shaft comprises a sheath and an elongate puncturing member received in the sheath, and the elongate puncturing member is extendable from the sheath to form an anchor.

9 . The shunting catheter of claim 1 , wherein the puncture element is a curved puncture element including a curved body and a tip, the tip of the curved puncture element extending along a first axis and the curved body extending along a second axis, wherein the first axis and the second axis form an angle greater than zero degrees.

10 . The shunting catheter of claim 1 , wherein the tissue-removal assembly comprises a plurality of puncturing wires extendable from the distal end of the shunting shaft, a distal portion of the plurality of puncturing wires being configured to form a plurality of anchors.

11 . The shunting catheter of claim 1 , wherein the tissue-removal assembly comprises a helical anchor being extendable from the distal end of the shunting shaft.

12 . The shunting catheter of claim 1 , wherein the distal end of the shunting shaft further comprises an expandable basket structure adjacent to the cutting component.

13 . The shunting catheter of claim 1 , wherein the cutting component comprises a shovel structure extending from the distal end of the shunting shaft.

14 . The shunting catheter of claim 13 , wherein the cutting component further comprises a slicing member extending from a base of the shovel structure.

15 . The shunting catheter of claim 1 , further comprising a vacuum mechanism fluidly connected to the opening at the distal end of the shunting shaft to generate a reduced pressure at the opening.

16 . The shunting catheter of claim 1 , wherein the distal end of the shunting shaft comprises a retention feature disposed on an inner wall of the distal end adjacent to the cutting component.

17 . The shunting catheter of claim 1 , wherein:

the tissue-removal assembly is configured to remove an area of tissue from the tissue wall to create a shunt at the second state; and

the shunting shaft is configured to receive at least a portion of the removed area of tissue at a third state.

18 . The shunting catheter of claim 17 , wherein the shunt has an outer diameter in a range from 3 mm to 15 mm.

19 . A method of creating a shunt, comprising:

deploying a tissue-removal assembly in a shaft lumen of a catheter shaft at a first state, the tissue-removal assembly comprising a shunting shaft having an opening at a distal end thereof, and the shunting shaft comprising a cutting component disposed at a distal end of the shunting shaft, the cutting component extending along a circumferential direction of the opening at the distal end of the shunting shaft;

operating the tissue-removal assembly to a second state, wherein the distal end of the shunting shaft extends from a side opening of the catheter shaft with a curved shape;

disposing the cutting component approximate to a tissue wall of a patient;

extending a puncture element from the distal end of the shunting shaft;

cutting, using the cutting component, the tissue wall; and

removing an area of tissue from the tissue wall to form an opening in the tissue wall using the tissue-removal assembly,

wherein a puncture element shaft connects the puncture element to the distal end of the shunting shaft, the puncture element shaft is configured to mechanically support the puncture element when the puncture element is extended from the shunting shaft at an extended state; and

wherein:

the puncture element includes a rear surface that is coupled to the puncture element shaft;

the rear surface of the puncture element has a first diameter;

the puncture element shaft has a second diameter; and

the first diameter is greater than the second diameter.

20 . The method of claim 19 , wherein the cutting component comprises an ablation electrode, and the cutting of the tissue wall comprises delivering ablation energy to a target location using the ablation electrode.

21 . The method of claim 19 , wherein the puncture element shaft is configured to extend the puncture element at a first distance at the extended state and at a second distance at a retracted state, wherein the first distance is greater than the second distance.

22 . The method of claim 19 , further comprising:

moving the puncture element to the extended state to puncture through the tissue wall,

wherein the puncture element further comprises a puncturing tip at a distal portion thereof.

23 . The method of claim 19 , further comprising:

retracting the puncture element back to the retracted state, wherein the puncture element further comprises an array of tissue capturing structures to grab the area of tissue into an opening at the distal end of the shunting shaft.

24 . The method of claim 19 , wherein the puncture element shaft comprises a sheath and an elongate puncturing member received in the sheath, and when the puncture element is at the extended state, exposing a distal portion of the elongate puncturing member to form an anchor.

25 . The method of claim 24 , further comprising grabbing the area of tissue into an opening at the distal end of the shunting shaft using the anchor when the puncture element is moved to the retracted state.

26 . The method of claim 19 , further comprising:

extending an elongate puncturing member from the distal end of the shunting shaft to puncture through the tissue wall;

forming an anchor at a distal portion of the elongate puncturing member; and

retracting the anchor to grab the area of tissue into an opening at the distal end of the shunting shaft.

27 . The method of claim 19 , further comprising:

extending a helical anchor from the distal end of the shunting shaft to puncture through the area of tissue; and

retracting the helical anchor to grab the area of tissue into an opening at the distal end of the shunting shaft.

28 . The method of claim 19 , further comprising expanding the distal end of the shunting shaft to form a basket structure adjacent to the cutting component.

29 . The method of claim 19 , wherein the cutting component comprises a shovel structure extending from the distal end of the shunting shaft.

30 . The method of claim 29 , wherein the cutting component further comprises a slicing component extending from a base of the shovel structure.

31 . The method of claim 19 , further comprising generating a reduced pressure at an opening at the distal end of the shunting shaft to pull the area of tissue into the opening.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 21, 2025
From: MAHMOUDI, RANI ABDULLAH; DASS, AJAY; GAN, WEI
To: THERAHEART INC.
Reel/Frame 071182/0409 →
Continuity (1)
Related Publication 20260090834A1 · Apr 2, 2026
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