PULMONARY ARTERY IMPLANT APPARATUS AND METHODS OF USE THEREOF

• US 20170172771A1
• Filed: 07/20/2015
• Published: 06/22/2017
• Est. Priority Date: 07/20/2014
• Status: Active Grant

• Current Assignee: Restore Medical Ltd.
• Original Assignee: Gil Naor, Stephen F. Bellomo
• Inventors: BELLOMO, Stephen F., Feld, Tanhum, Bruckheimer, Elchanan, NAOR, Gil
• Granted Patent: US 10,667,931 B2
• Time in Patent Office: 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. An apparatus comprising:

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

(b) a 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 the 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.

2. The apparatus according to claim 1, wherein the anchor frame is placed in the left pulmonary artery or the right pulmonary artery.

3. The apparatus according to claim 2, wherein when said anchor frame is place in the left pulmonary artery, said anchor frame further comprises a protrusion which extends into the right pulmonary artery when said apparatus is in an expanded position.

5. The apparatus according to claim 1, wherein the apparatus is deliverable in a collapsed configuration by a transcatheter procedure.

6. The apparatus according to claim 1, wherein said device frame further comprises a medical device selected from the group comprising a flow restrictor, a valve, a filter, a pacemaker, a sensor or a drug delivery platform.

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16. A method of treating, reducing the severity of, delaying the onset of or reducing symptoms associated with any cardiac or pulmonary condition that requires blood flow reduction through a pulmonary artery in a human,

said method comprising the steps of:

(1) implanting an apparatus using transcatheter delivery such that an anchor frame resides within a branch pulmonary artery and a device frame resides within the MPA; and

(2) adjusting a flow restrictor to reduce the effective diameter of the MPA;

wherein implantation of the apparatus treats, reduces the severity of, delays the onset of, or reduces symptoms associated with any cardiac or pulmonary condition that requires blood flow reduction through a pulmonary artery in a human.

17. The method according to claim 16, wherein said transcatheter delivery is performed with the apparatus in a collapsed configuration.

18. The method according to claim 16, 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 flow restrictor.

19. The method according to claim 18, wherein said anchor frame is placed in the left pulmonary artery or in the right pulmonary artery.

20. The method according to claim 19, wherein when said anchor frame is place in the left pulmonary artery said anchor frame further comprises a protrusion which extends into the right pulmonary artery when said apparatus is in an expanded position.

35. The method according to claim 16, wherein said method treats, reduces the severity of, delays the onset of or reduces the symptoms associated with left ventricular failure in said human, or any combination thereof.

36. The method according to claim 16, where said method repositions, supports, or repositions and supports the interventricular septum in a human patient suffering from any cardiac or pulmonary condition that requires blood flow reduction through a pulmonary artery.

37. The method according to claim 36, wherein said human has left-ventricle failure.

38. The method according to claim 16, wherein said human is an infant, a child or an adult.

43. The method according to claim 16, wherein said cardiac or pulmonary condition comprises congestive heart failure, or any cardiac or pulmonary condition that requires increased afterload of the right ventricle, increased pressure in the right ventricle, repositioning of the interventrical septum, improved left ventricle function, increased left ventricle cardiac output, or any combination thereof.

44. The method according to claim 36, wherein said human has left ventricular failure and preserved right ventricular function.

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39. A method of treating, reducing the severity of, delaying the onset of or reducing symptoms associated with left ventricle failure in an adult subject, said method comprising pulmonary artery banding (PAB).

40. The method according to claim 39, wherein said left ventricle failure is caused by ischemic damage.

41. The method according to claim 39, wherein said PAB comprises external PAB.

42. The method according to claim 39, wherein said PAB comprises intravascular PAB.