CN-122005070-A - Expandable element for shunt catheter

Abstract

At least some embodiments of the present disclosure relate to systems and methods for creating a shunt in a patient. In some embodiments, a shunt catheter includes a catheter shaft having a distal end and a proximal end, a balloon shaft including a shaft lumen, the balloon shaft disposed in the shaft lumen in a first state and extending from the catheter shaft in a second state, at least one of the one or more electrodes disposed on the balloon shaft and expandable in the second state, and a balloon member disposed on the balloon member.

Inventors

• Rani Abdullahmahmoud

Assignees

• 塞纳医疗公司

Dates

Publication Date

20260512

Application Date

20240301

Priority Date

20230303

Claims (20)

1. 1. A shunt catheter, comprising: a catheter shaft including a shaft lumen; A balloon shaft disposed in the shaft lumen in a first state and extending from the catheter shaft in a second state; A balloon element disposed on the balloon shaft and inflatable in the second state, the balloon element including an anchor component configured to position the balloon element at a target location of a patient and a shunt component, and At least one electrode of one or more electrodes disposed on the shunt member, the one or more electrodes configured to deliver ablation energy at a target location of a patient; Wherein the diameter of the shunt member is smaller than the diameter of the anchor member when the anchor member and the shunt member are inflated, Wherein the shunt member has a first longitudinal length along a first axis defined by the balloon shaft; wherein the at least one electrode has a second longitudinal length along the first axis; Wherein the second longitudinal length is at least 70% of the first longitudinal length.
2. 2. The shunt catheter of claim 1, wherein the catheter shaft defines a second axis, wherein the second axis and the first axis form an angle greater than zero degrees.
3. 3. The shunt catheter of claim 1, wherein: the balloon element includes a plurality of pleats in the first state; A first pleat of the plurality of pleats includes a first pleating surface on a first side of the first pleat and a second pleating surface on a second side of the first pleat; The second side is opposite the first side; in the first state, a first electrode of the one or more electrodes is disposed entirely on the first pleated surface; In the first state, a second electrode of the one or more electrodes is disposed entirely on the second pleated surface.
4. 4. The shunt catheter of claim 3, wherein the first electrode in the first state extends substantially parallel to the balloon axis.
5. 5. The shunt catheter of claim 1, wherein the balloon element has a balloon length along the first axis and a balloon width perpendicular to the first axis, wherein the balloon length is greater than the balloon width when the balloon element is inflated.
6. 6. The shunt catheter of claim 1, wherein the balloon element has a diameter in the range of three millimeters to fifteen millimeters when inflated.
7. 7. The shunt catheter of claim 1, wherein the balloon element has a first inflated state and a second inflated state, wherein the balloon element has a first balloon diameter in the first inflated state, wherein the balloon element has a second balloon diameter in the second inflated state, wherein the first balloon diameter is different than the second balloon diameter.
8. 8. The shunt catheter of claim 1 wherein the balloon element comprises a first inflatable portion having a first balloon diameter and a second inflatable portion having a second balloon diameter when the balloon element is inflated, wherein the first balloon diameter is different from the second balloon diameter.
9. 9. The shunt catheter of claim 1, wherein the balloon element comprises a narrow section intermediate the balloon element, wherein the balloon element comprises a first section at a distal end of the balloon element and a second section at a proximal end of the balloon element, wherein the narrow section is between the first section and the second section, wherein the narrow section has a diameter that is less than a diameter of the first section or a diameter of the second section.
10. 10. The shunt catheter of any one of claims 1-9, wherein the balloon element has a cross-sectional shape perpendicular to the first axis, wherein the cross-sectional shape is circular, elliptical, or rectangular.
11. 11. The shunt catheter of any one of claims 1-9, wherein the anchoring member and the shunt member share an internal lumen.
12. 12. The shunt catheter of any one of claims 1-9, wherein the anchoring member is a first balloon and the shunt member is a second balloon that does not share a lumen with the first balloon.
13. 13. The shunt catheter of any one of claims 1-9, wherein the anchor member is configured to be inflated in a first inflation state and the shunt member is configured to remain collapsed in the first inflation state, the anchor member is configured to remain inflated in a second inflation state and the shunt member is configured to be inflated in the second inflation state.
14. 14. The shunt catheter of claim 13, wherein the anchoring member is configured to pull back the tissue wall in the first inflation state.
15. 15. The shunt catheter of claim 13, wherein the anchoring member has a proximal surface defining a plane that is angled relative to the first axis in the first inflated state, wherein the angle of the proximal surface to the first axis is approximately 90 degrees.
16. 16. A shunt catheter system comprising: An ablative energy source; An inflation source, and A shunt catheter coupled to the ablation energy source and the inflation source, the shunt catheter comprising: -a catheter shaft comprising a shaft lumen; -a balloon shaft disposed in the shaft lumen in a first state and extending from the catheter shaft in a second state; A balloon element disposed on the balloon shaft and configured to be at least partially inflated by the inflation source in the second state, the balloon element including an anchor component configured to position the balloon element at a target location of a patient and a shunt component, and At least one electrode of one or more electrodes disposed on the shunt member, the one or more electrodes configured to receive energy from the ablation energy source and deliver ablation energy at the target location of the patient; Wherein the diameter of the shunt member is smaller than the diameter of the anchor member when the anchor member and the shunt member are inflated, Wherein the shunt member has a first longitudinal length along a first axis defined by the balloon shaft; wherein the at least one electrode has a second longitudinal length along the first axis; Wherein the second longitudinal length is at least 70% of the first longitudinal length.
17. 17. The shunt catheter system of claim 16, wherein: the balloon element includes a plurality of pleats in the first state; A first pleat of the plurality of pleats includes a first pleating surface on a first side of the first pleat and a second pleating surface on a second side of the first pleat; The second side is opposite the first side; in the first state, a first electrode of the one or more electrodes is disposed entirely on the first pleated surface; In the first state, a second electrode of the one or more electrodes is disposed entirely on the second pleated surface.
18. 18. The shunt catheter system of claim 17, wherein the first electrode in the first state extends substantially parallel to the balloon axis.
19. 19. The shunt catheter system of claim 17, wherein the balloon element has a balloon length along the first axis and a balloon width perpendicular to the first axis, wherein the balloon length is greater than the balloon width when the balloon element is inflated.
20. 20. The shunt catheter system of claim 17, wherein the balloon element has a diameter in the range of three millimeters to fifteen millimeters when inflated.

Description

Expandable element for shunt catheter The application is a divisional application of national application number 202480029750.3, the application name is 'an expandable element for a shunt catheter', which enters a patent application of China with the date of 2025, 10 and 31 days. Cross reference to related applications The present application claims priority from U.S. provisional application No. 63/449,878, filed 3 at 2023, and U.S. provisional application No. 65/558,028, filed 26 at 2024, which are incorporated herein by reference for all purposes. Technical Field Particular embodiments of the present disclosure relate to medical systems, devices, and methods for creating a shunt in a patient. More particularly, some embodiments of the present disclosure relate to medical systems, devices, and methods for creating a shunt on a cardiovascular system wall within a patient. Background Heart failure is a serious condition that occurs when the heart is unable to pump enough blood and oxygen to support other organs in the body. Heart failure is classified as "reduced Ejection Fraction (EF) heart failure" (HFrEF; EF < 40%), "mid-range EF" (HFmrEF; EF 40-49%) or "reserved EF" (HFpEF; EF > 50%) according to Left Ventricular (LV) function. About half of heart failure patients suffer from HFpEF. HFpEF typically occurs when LV and left atrial filling pressures increase significantly during exercise, with an associated increase in pulmonary pressure resulting in pulmonary congestion. Structural interventions that reduce elevated left atrial filling pressure or right atrial filling pressure are gaining attention. Studies of heart failure have shown that lowering left atrial pressure can reduce cardiovascular events while improving functional capacity. Creation of atrial shunts has become a therapy for depressurizing the left atrium in patients with acute and chronic left HF. Accordingly, attention is directed to the development of atrial shunt devices (IASD) as a means of reducing the detrimental increase in left side filling pressure with exercise in an effort to improve symptoms (IASD). IASD can be used to treat various heart failure, and/or other diseases that may result in excessive pressure in the right atrium of the patient. Disclosure of Invention Currently IASD is present in the atrial septum, which IASD carries the risk of shunt and systemic embolism from right to left. Furthermore, as the number of left transseptal catheterization interventions increases, the maintenance of the atrial septum is important. There is a need for improved IASD methods to achieve safer and better surgical methods. According to some embodiments, a shunt catheter includes a catheter shaft having a distal end and a proximal end, the catheter shaft including a shaft lumen, a balloon shaft disposed in the shaft lumen in a first state and extending from the catheter shaft in a second state, a balloon element disposed on the balloon shaft and expandable in the second state, and at least one of the one or more electrodes disposed on the balloon element. In some embodiments, the catheter shaft defines a first axis, wherein the balloon shaft defines a second axis in the second state, wherein the second axis and the first axis form an angle greater than zero degrees. In a particular embodiment, the balloon element has a balloon length along the second axis and a balloon width perpendicular to the second axis, wherein the balloon length is greater than the balloon width when the balloon element is inflated. In some embodiments, the balloon element has a balloon length along the second axis and a balloon width perpendicular to the second axis, wherein the balloon length is less than the balloon width when the balloon element is inflated. In particular embodiments, the balloon element has a diameter in the range of three millimeters to fifteen millimeters when inflated. In some embodiments, the balloon element has a first inflated state and a second inflated state, wherein the balloon element has a first balloon diameter in the first inflated state, wherein the balloon element has a second balloon diameter in the second inflated state, and wherein the first balloon diameter is different than the second balloon diameter. In a particular embodiment, the balloon element includes a first inflatable portion having a first balloon diameter and a second inflatable portion having a second balloon diameter when the balloon element is inflated, wherein the first balloon diameter is different from the second balloon diameter. In some embodiments, the balloon element includes a narrow section intermediate the balloon element, wherein the balloon element includes a first section at a distal end of the balloon element and a second section at a proximal end of the balloon element, wherein the narrow section is between the first section and the second section, wherein the narrow section has a diameter that is less than a diameter of the first section or a diamet