Apparatus and methods for treating pulmonary hypertension

• US 9,028,391 B2
• Filed: 04/04/2014
• Issued: 05/12/2015
• Est. Priority Date: 12/15/2011
• Status: Active Grant

• Current Assignee: Board of Trustees of the Leland Stanford Junior University (Stanford University)
• Original Assignee: Board of Trustees of the Leland Stanford Junior University (Stanford University)
• Inventors: Gnanashanmugam, Swaminadhan, Coe, Jonathan A., Suh, Insoo, Koehler, Jeremy Christopher
• Primary Examiner(s): Marmor, II, Charles A
• Assistant Examiner(s): Dorna, Carrie R
• Application Number:
  US14/244,900
• Publication Number:
  US 20140221975A1
• Time in Patent Office: 403 Days
• Field of Search: 600 20- 34, 600/45, 600 48- 50, 607/44, 606 20- 34, 606/45, 606 48- 50
• US Class Current: 600/9
• CPC Class Codes: A61B 17/00 Surgical instruments, devices or methods, e.g. tourniquets A61B18/00 takes precedence; contraceptive devices, pessaries, or applicators therefor A61F6/00; eye surgery A61F9/007; ear surgery A61F11/00
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 18/04 by heating by applying electromagnetic radiation A61B18/18; hyperthermia using electric or magnetic fields, radiation or ultrasound A61N
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 18/1815 using microwaves
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00345 Vascular system
• CPC Class Codes: A61B 2018/00357 Endocardium
• CPC Class Codes: A61B 2018/00375 Ostium, e.g. ostium of pulmonary vein or artery
• CPC Class Codes: A61B 2018/00404 Blood vessels other than those in or around the heart
• CPC Class Codes: A61B 2018/00434 Neural system
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00613 Irreversible electroporation
• CPC Class Codes: A61B 2018/0212 using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 2018/046 in liquid form
• CPC Class Codes: A61B 2018/143 multiple needles
• CPC Class Codes: A61B 2018/1432 curved
• CPC Class Codes: A61M 2025/006 having a special surface topography or special surface properties, e.g. roughened or knurled surface
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• CPC Class Codes: A61M 25/0043 : characterised by structural features
• CPC Class Codes: A61M 25/10 : Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1002 : characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 29/00 : Dilators with or without means for introducing media, e.g. remedies instruments for performing visual medical inspections of cavities or tubes of the body A61B1/00
• CPC Class Codes: A61M 29/02 : Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: A61N 1/0551 : Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36117 : for treating hypertension
• CPC Class Codes: A61N 2/02 : using magnetic fields produced by coils, including single turn loops or electromagnets A61N2/12 takes precedence
• CPC Class Codes: A61N 2/06 : using magnetic fields produced by permanent magnets A61N2/12 takes precedence
• CPC Class Codes: A61N 2007/003 : Destruction of nerve tissue
• CPC Class Codes: A61N 5/1002 : Intraluminal radiation therapy
• CPC Class Codes: A61N 7/022 : intracavitary

Abstract

A method is described for decreasing activity of at least one sympathetic nerve, nerve fiber or neuron innervating at least one blood vessel in the pulmonary vasculature of a patient to ameliorate pulmonary hypertension. In one embodiment, the method may involve advancing an intravascular treatment device to a target location in a target blood vessel within the pulmonary vasculature of the patient and using the treatment device to decrease activity of at least one sympathetic nerve, nerve fiber or neuron innervating the target blood vessel at or near the target location to ameliorate pulmonary hypertension.

Claims

1. A method of performing a procedure to destroy nerve fibers of a nerve innervating a pulmonary artery to treat pulmonary hypertension in a patient, the method comprising:

advancing a distal portion of a therapy delivery catheter to a target location in the pulmonary artery of the patient;

changing a shape of the distal portion of the catheter from a first configuration to a second configuration to cause the distal portion to contact an inner wall of the pulmonary artery at the target location;

delivering a therapy from at least one therapy delivery member disposed along the distal portion of the catheter to destroy the nerve fibers along a length of the nerve to treat the pulmonary hypertension in the patient; and

removing the catheter from the pulmonary artery and from the patient at the end of the procedure.

2. A method as in claim 1, further comprising, before removing the catheter, changing the shape of the distal portion from the second configuration to the first configuration.

3. A method as in claim 1, wherein the nerve comprises a sympathetic nerve.

4. A method as in claim 1, wherein changing the shape of the distal portion from the first configuration to the second configuration comprises inflating an inflatable balloon.

5. A method as in claim 1, wherein changing the shape of the distal portion from the first configuration to the second configuration comprises releasing a shape-memory portion of the catheter from a constraint to allow it to assume a default configuration.

6. A method as in claim 1, wherein the at least one therapy delivery member comprises at least one energy delivery member, and wherein delivering the therapy comprises delivering a form of energy selected from the group consisting of radiofrequency, ultrasound, microwave, light, heat, cold, radiation, phototherapy, magnetic, electrical, electromagnetic, cryotherapy, plasma, mechanical, chemical, kinetic, potential, nuclear, elastic and hydrodynamic energy.

7. A method as in claim 1, wherein the at least one therapy delivery member comprises at least one substance delivery member, and wherein delivering the therapy comprises delivering at least one substance via the at least one substance delivery member.

8. A method as in claim 1, wherein delivering the therapy from the at least one therapy delivery member comprises delivering the therapy from multiple therapy delivery members disposed along a length of the distal portion and around a circumference of the distal portion.

9. A method as in claim 1, wherein, after the catheter is removed, no implant is left behind in the pulmonary artery.

10. A method of performing a procedure to treat pulmonary hypertension by reducing pulmonary vascular resistance in a patient, the method comprising:

advancing an energy delivery portion of a catheter to a target location in a pulmonary artery;

changing a shape of the energy delivery portion from a first configuration to a second configuration to contact an inner wall of the pulmonary artery at the target location with multiple, circumferential energy delivery members disposed at separated locations along a length of the energy delivery portion;

delivering energy from the energy delivery members to destroy nerve fibers of a sympathetic nerve that innervates the pulmonary artery to reduce the pulmonary vascular resistance in the patient and thus treat pulmonary hypertension; and

removing the catheter from the pulmonary artery at the end of the procedure.

11. A method as in claim 10, further comprising, before removing the catheter, changing the shape of the energy delivery portion from the second configuration to the first configuration.

12. A method as in claim 10, wherein changing the shape of the energy delivery portion from the first configuration to the second configuration comprises inflating an inflatable balloon.

13. A method as in claim 10, wherein changing the shape of the energy delivery portion from the first configuration to the second configuration comprises releasing a shape-memory portion of the catheter from a constraint to allow it to assume a default configuration.

14. A method as in claim 10, wherein delivering energy from the energy delivery members comprises delivering a form of energy selected from the group consisting of radiofrequency, ultrasound, microwave, light, heat, cold, radiation, phototherapy, magnetic, electrical, electromagnetic, cryotherapy, plasma, mechanical, chemical, kinetic, potential, nuclear, elastic and hydrodynamic energy.

15. A method as in claim 10, wherein, after the catheter is removed, no implant is left behind in the pulmonary artery.