Apparatus, systems, and methods for percutaneous pneumatic cardiac assistance
AssigneePercAssist, Inc.
InventorsAlbert K. CHIN, Gerardo NORIEGA, Sage MORELAND
Life of this patent
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Abstract
Described herein are an implantable cardiac assist system and methods of delivery and use thereof. The system can include one or more of an external drive unit, an anchor wire, an implantable cardiac assist catheter, and a pneumatic effector. The pneumatic effector can be a balloon. The anchor wire can include a spiral anchor at the distal tip for anchoring the pneumatic. The system can be used with ECG electrodes to monitor the rhythm of the heart and adjust the action of the pneumatic effector based on the rhythm of the heart.
Claims94
An implantable cardiac assist system, comprising:
- (a) an external drive unit;
- (b) an anchor wire configured to be anchored to a pericardium of a subject;
- (c) an implantable cardiac assist catheter comprising a distal section;
- and
- (d) a pneumatic effector configured to be operatively coupled to the external drive unit, wherein the pneumatic effector is coupled to the distal section of the implantable cardiac assist catheter and configured to be implanted beneath a pericardial sac of the subject and over a myocardial surface overlying a left ventricle of the subject;
- (e) wherein the distal section of the implantable cardiac assist catheter has a guidewire lumen with a first port proximal to the pneumatic effector and a second port distal to the pneumatic effector, and wherein the implantable cardiac assist catheter is configured to be advanced over the anchor wire via the guidewire lumen.
A method for implanting a cardiac assist system, the method comprising:
- (a) inserting a guidewire into an intrapericardial space anterior to a heart of a subject at an apical site;
- (b) advancing a vascular sheath and a tapered dilator over the guidewire;
- (c) advancing a pericardial anchor wire to a lateral aspect of a pericardium of the heart;
- (d) anchoring the pericardial anchor wire to the lateral aspect of the pericardium;
- and
- (e) advancing an implantable cardiac assist catheter over the pericardial anchor wire via a guidewire lumen of the implantable cardiac assist catheter with a first port proximal to a pneumatic effector and a second port distal to the pneumatic effector, thereby positioning the implantable cardiac assist catheter anterior to the heart.
A cardiac assist system, comprising:
- (a) an external drive unit;
- (b) an implantable cardiac assist catheter comprising a distal section having a guidewire lumen;
- (c) a pneumatic effector configured to be operatively coupled to the external drive unit, wherein the pneumatic effector is coupled to the distal section of the implantable cardiac assist catheter, wherein the distal section of the implantable cardiac assist catheter has a first port proximal to the pneumatic effector and a second port distal to the pneumatic effector, wherein the pneumatic effector is configured to be implanted beneath a pericardial sac of a subject and over a myocardial surface overlying a left ventricle of the subject, and wherein the pneumatic effector comprises a partially elastic balloon configured to inflate with a cushioning effect on a myocardium of the subject;
- and
- (d) an anchor wire, wherein the anchor wire is configured to anchor the partially elastic balloon to a position anterior to a heart.
A method for implanting a cardiac assist system, the method comprising:
- (a) anchoring a pericardial anchor wire to a lateral aspect of a pericardium;
- (b) advancing a guidewire lumen of an implantable cardiac assist catheter over an anchor wire into a position anterior to a heart;
- and
- (c) anchoring a pneumatic effector to the position anterior to the heart, the pneumatic effector being coupled to a distal end of the implantable cardiac assist catheter and configured to be implanted beneath a pericardial sac of a subject and over a myocardial surface overlying a left ventricle of the subject, wherein the pneumatic effector comprises a partially elastic balloon;
- (d) wherein the partially elastic balloon is configured to inflate with a cushioning effect on a myocardium of the subject at the position anterior to the heart in response to gas being driven thereto.
A method for assisting cardiac function in a subject suffering from heart failure, the method comprising:
- (a) measuring the subject's ECG to determine a cardiac rhythm;
- and
- (b) delivering a driving gas to expand and contract a pneumatic effector implanted over the subject's left ventricle in response to the measured ECG, wherein the pneumatic effector comprises a partially elastic balloon;
- (c) wherein the driving gas delivery is synchronized with the determined cardiac rhythm to cause the partially elastic balloon to compress a heart of the subject at a rate which matches the cardiac rhythm,
- (d) wherein the partially elastic balloon is configured to inflate with a cushioning effect on a myocardium of the subject at a position anterior to the heart in response to gas being driven thereto.
A cardiac assist system comprising:
- (a) an external drive unit;
- (b) an implantable cardiac assist catheter comprising a distal section;
- (c) a pneumatic effector configured to be operatively coupled to the external drive unit, wherein the pneumatic effector is coupled to the distal section of the implantable cardiac assist catheter and configured to be implanted beneath a pericardial sac of a subject and over a myocardial surface overlying a left ventricle of the subject, and
- (d) wherein the pneumatic effector comprises a balloon having a size of at least about 120 cc and configured to displace a left ventricular wall by at least about 4 cm.
A method for implanting a cardiac assist system, the method comprising:
- (a) anchoring a pericardial anchor wire to a lateral aspect of a pericardium;
- (b) advancing an implantable cardiac assist catheter into a position anterior to a heart;
- and
- (c) anchoring a pneumatic effector to the position anterior to the heart, the pneumatic effector being coupled to a distal end of the implantable cardiac assist catheter, wherein the pneumatic effector comprises a balloon having a size of at least about 120 cc;
- (d) wherein a partially elastic balloon is configured to receive a driving gas delivered thereto to be inflated;
- and
- (e) wherein the partially elastic balloon is configured to displace a left ventricular wall of the heart by at least about 4 cm in response to being inflated.
A method for assisting cardiac function in a subject suffering from heart failure, the method comprising:
- (a) measuring the subject's ECG to determine a cardiac rhythm;
- and
- (b) delivering a driving gas to expand and contract a pneumatic effector implanted over the subject's left ventricle in response to the measured ECG, wherein the pneumatic effector comprises a balloon having a size of at least about 120 cc;
- (c) wherein the balloon is configured to displace a left ventricular wall by at least about 4 cm while expanding the balloon,
- (d) wherein the driving gas delivery is synchronized with the determined cardiac rhythm to cause the balloon to compress a heart of the subject at a rate which matches the cardiac rhythm.
An implantable cardiac assist system, comprising:
- (a) an external drive unit;
- (b) an anchor wire configured to be anchored to a pericardium of a subject;
- (c) an implantable cardiac assist catheter comprising a distal section;
- and
- (d) a pneumatic effector configured to be operatively coupled to the external drive unit, wherein the pneumatic effector is coupled to the distal section of the implantable cardiac assist catheter and configured to be implanted beneath a pericardial sac of the subject and over a myocardial surface overlying a left ventricle of the subject,
- (e) wherein the implantable cardiac assist catheter is configured to be advanced over the anchor wire via a guidewire lumen, and
- (f) wherein one or more of
- (i) the pneumatic effector comprises a balloon having a size of at least about 120 cc, wherein the balloon is configured to displace a left ventricular wall by at least about 4 cm while expanding the balloon;
- (ii) the pneumatic effector comprises a partially elastic balloon configured to inflate with a cushioning effect on a myocardium of the subject at a position anterior to the heart in response to gas being driven thereto;
- or
- (iii) the distal section of the implantable cardiac assist catheter has a guidewire lumen with a first port proximal to the pneumatic effector and a second port distal to the pneumatic effector.
A method for implanting a cardiac assist system, the method comprising:
- (a) anchoring a pericardial anchor wire to a lateral aspect of a pericardium;
- (b) advancing a guidewire lumen of an implantable cardiac assist catheter over the anchor wire into a position anterior to a heart;
- and
- (c) anchoring a pneumatic effector to the position anterior to the heart, the pneumatic effector being coupled to a distal end of the implantable cardiac assist catheter and configured to be implanted beneath a pericardial sac of the subject and over a myocardial surface overlying a left ventricle of the subject;
- (d) wherein one or more of
- (i) the pneumatic effector comprises a balloon having a size of at least about 120 cc, wherein the balloon is configured to displace a left ventricular wall by at least about 4 cm while expanding the balloon;
- (ii) the pneumatic effector comprises a partially elastic balloon configured to inflate with a cushioning effect on a myocardium of the subject at a position anterior to the heart in response to gas being driven thereto;
- or
- (iii) a distal section of the implantable cardiac assist catheter has a guidewire lumen with a first port proximal to the pneumatic effector and a second port distal to the pneumatic effector.
Dependencies are inferred from the claim text.