Pulmonary artery implant apparatus and methods of use thereof

• US 10,667,931 B2
• Filed: 07/20/2015
• Issued: 06/02/2020
• Est. Priority Date: 07/20/2014
• Status: Active Grant

• Current Assignee: Restore Medical Ltd.
• Original Assignee: Restore Medical Ltd.
• Inventors: Bruckheimer, Elchanan, Feld, Tanhum, Naor, Gil, Bellomo, Stephen F.
• Primary Examiner(s): Stewart, Alvin J
• Application Number:
  US15/327,075
• Publication Number:
  US 20170172771A1
• Time in Patent Office: 1,779 Days
• CPC Class Codes: A61B 17/12036 partial occlusion
• CPC Class Codes: A61B 17/12104 in an air passage
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/2421 with non-pivoting rigid closure members
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2002/061 provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/068 Modifying the blood flow model, e.g. by diffuser or deflector
• CPC Class Codes: A61F 2002/825 having longitudinal struts
• CPC Class Codes: A61F 2002/828 Means for connecting a plurality of stents allowing flexibility of the whole structure
• CPC Class Codes: A61F 2002/8486 provided on at least one of the ends
• CPC Class Codes: A61F 2002/91508 the meander having a difference in amplitude along the band
• CPC Class Codes: A61F 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body

Abstract

The present invention relates to an implantable apparatus and methods of use thereof for treating congestive heart failure. An apparatus of this invention may be anchored by implantation of a section of the apparatus within in a branch pulmonary artery, for example the left pulmonary artery, which then positions and anchors another section, for example a device frame section of the apparatus within the main pulmonary artery. A medical device may be attached to the anchored device frame.

Claims

1. A method of reducing symptoms associated with any cardiac condition the method comprising the steps of:

(1) identifying ischemic cardiomyopathy in a human adult;

(2) implanting an apparatus in the human adult using transcatheter delivery, wherein the apparatus includes an anchor frame and a device frame such that an anchor frame resides within a branch pulmonary artery and a device frame resides within the main pulmonary artery (MPA), wherein the device frame includes a restricting element; and

(3) sensing pressure in a right ventricle of the human adult heart;

(4) adjusting the restricting element to reduce the effective diameter of the MPA, wherein the restricting element is adjusted based on the pressure sensed;

wherein implantation of the apparatus reduces symptoms associated with any cardiac condition in the human adult.

2. The method according to claim 1, wherein said transcatheter delivery is performed with the apparatus in a collapsed configuration.

3. The method according to claim 1, wherein said apparatus comprises:

(a) the anchor frame for placement in a branch pulmonary artery;

(b) the device frame for placement in the main pulmonary artery (MPA); and

(c) a connecting section;

wherein said anchor frame, said device frame and said connecting section comprise a single entity, an apparatus frame, wherein said anchor frame comprises one section of the apparatus frame, said device frame comprises another section of apparatus frame, and said connecting section connects the anchor frame and the device frame of the apparatus frame, and wherein said anchor frame is used to position the device frame within the MPA when said apparatus is in an expanded position; and

wherein said device frame comprises an adjustable restricting element.

4. The method according to claim 3, wherein said anchor frame is placed in the left pulmonary artery or in the right pulmonary artery.

5. The method according to claim 4, wherein when said anchor frame is place in the left pulmonary artery said anchor frame further comprises an extension of the anchor frame which extends into the right pulmonary artery when said apparatus is in an expanded position.

6. The method according to claim 1, wherein said method is configured to reduce symptoms associated with left ventricular failure in said human adult.

7. The method according to claim 1, where said method is configured to reposition and support the interventricular septum in the human adult.

8. The method according to claim 7 wherein the adjusting is configured to reduce symptoms associated left-ventricle failure.

9. The method according to claim 7, wherein the banding is configured to be applied on said human with left ventricular failure and preserved right ventricular function.

10. The method according to claim 1, wherein the sensing pressure in the right ventricle of the heart is based on one or more of sensing pressure at defined locations by catherization, sensing pressure by echocardiography and sensing pressure with at least one pressure sensor attached to the apparatus.

11. The method according to claim 10, wherein the at least one pressure sensor is attached upstream to the restricting element.

12. A method of reducing symptoms associated with left ventricle failure in a human adult, said method comprising:

banding a pulmonary artery of a human adult having left ventricle failure, wherein the banding comprises intravascular pulmonary artery banding (PAB); and

reducing symptoms associated with the left ventricle failure in the human adult based on the banding.

13. The method according to claim 12, wherein said left ventricle failure is caused by ischemic damage and wherein the banding is configured to reduce symptoms associated with the ischemic damage.

14. The method according to claim 12, wherein the banding is configured to be controllably adjusted in vivo.

15. The method according to claim 12, wherein the banding is configured to increase pressure in the right ventricle.

16. The method according to claim 12, wherein the banding is configured to reposition the interventricular septum.

17. A method of reducing symptoms associated with left ventricle failure in a human adult, said method comprising:

banding a pulmonary artery of a human adult having left ventricle failure, wherein the banding is configured to increase pressure in the right ventricle; and

reducing symptoms associated with the left ventricle failure in the human adult based on the banding.

18. The method according to claim 17, wherein the banding is external pulmonary artery banding (PAB).

19. The method according to claim 17, wherein the banding is configured to be controllably adjusted in vivo.

20. The method according to claim 17, wherein the banding is configured to reposition the interventricular septum.