# US 12,097,364 B2 · Apparatus, systems, and methods for percutaneous pneumatic cardiac assistance > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,097,364 B2 - Document ID: US12097364B2 - Status: Granted - Kind: B2 - Application number: 17/411,928 - Filed: 2021-08-25 - Published: 2021-12-09 - Granted: 2024-09-24 - Earliest claimed: 2019-02-26 - Assignees: PercAssist, Inc. - Applicants: PercAssist, Inc. - Inventors: Albert K. Chin; Gerardo Noriega; William Hsu - Web page: https://patentgrep.com/patent/US12097364B2 ## CPC - A61M 60/191: mechanically acting upon the outside of the patient's native heart, e.g. compressive structures placed around the heart - A61M 60/295: Balloon pumps for circulatory assistance - A61M 60/104: Extracorporeal pumps, i.e. the blood being pumped outside the patient's body - A61M 60/178: drawing blood from a ventricle and returning the blood to the arterial system via a cannula external to the ventricle, e.g. left or right ventricular assist devices - A61M 60/216: including a rotating member acting on the blood, e.g. impeller - A61M 60/289: Devices for mechanical circulatory actuation assisting the residual heart function by means mechanically acting upon the patient's native heart or blood vessel structure, e.g. direct cardiac compression [DCC] devices - A61M 60/405: the force acting on the blood contacting member being hydraulic or pneumatic - A61M 60/468: the force acting on the actuation means being hydraulic or pneumatic - A61M 60/515: Regulation using real-time patient data - A61M 60/569: synchronous with the native heart beat - A61M 60/839: of devices for mechanical circulatory actuation - A61M 60/841: of balloon pumps for circulatory assistance - A61M 60/845: of extracorporeal blood pumps - A61M 60/865: Devices for guiding or inserting pumps or pumping devices into the patient's body - A61M 2039/0244: {having means for detecting an inserted needle} - A61M 2230/04: Heartbeat characteristics, e.g. ECG, blood pressure modulation - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} ## Abstract A cardiac assist system includes a pneumatic effector which is implanted beneath a pericardial sac and over a myocardial surface overlying the patient's left ventricle. A port is implanted and receives a percutaneously introduced cannula. The port is connected to supply a driving gas received from the cannula to the pneumatic effector. An external drive unit includes a pump assembly and control circuitry which operate the pump to actuate the pneumatic effector in response to the patient's sensed heart rhythm. A connecting tube has a pump end connected to the pump and a percutaneous port-connecting end attached to the implantable port. ## Claims ### Claim 1 A cardiac assist system comprising: a pneumatic effector configured to be implanted to only a space beneath a patient's pericardial sac and over a myocardial surface overlying the patient's left ventricle and configured to selectively expand and contract within said space, wherein the pneumatic effector is elliptical in shape and has a length configured to extend along a major portion of the ventricular cavity; an implantable port configured to receive a percutaneously introduced cannula, wherein said port is connected to supply a driving gas received from the cannula to the pneumatic effector; an external drive unit including: (a) a pump assembly configured to alternately (i) deliver the driving gas to the pneumatic effector to expand the pneumatic effector during cardiac systole and (ii) withdraw the driving gas from the pneumatic effector to contract the pneumatic effector during cardiac diastole; and (b) control circuitry configured to operate the pump assembly to actuate the pneumatic effector in synchrony with the patient's cardiac rhythm as measured by an electrocardiogram (ECG); and a connecting tube having a pump end attachable to the pump assembly and a cannula end attached to the cannula. ### Claim 2 (depends on 1) The cardiac assist system of claim 1, wherein the control circuitry is configured to deliver the driving gas to the pneumatic effector at the start of the QRS complex or R wave peak of the measured ECG. ### Claim 3 (depends on 1) The cardiac assist system of claim 1, further comprising an anchor disposed distally of the pneumatic effector on a catheter body and configured to be deployed at the patient's pericardial sac to stabilize the pneumatic effector in position within the space beneath the patient's pericardial sac and over a myocardial surface overlying the patient's left ventricle. ### Claim 4 A method for assisting cardiac function in a patient suffering from heart failure, said method comprising: detecting the patient's electrocardiogram (ECG) to determine a cardiac rhythm; percutaneously accessing an implanted port with a cannula; alternately delivering and withdrawing a driving gas through the cannula to the implanted port which is connected to a pneumatic effector implanted to only a space beneath the patient's pericardial sac and over a myocardial surface overlying the patient's left ventricle and to selectively expand and contract within said space, wherein the pneumatic effector is elliptical in shape and has a length configured to extend along a major portion of the ventricular cavity; wherein the alternately delivering and withdrawing of the driving gas is synchronized with the determined cardiac rhythm to cause the pneumatic effector to compress and decompress the heart at a rate which matches the cardiac rhythm. ### Claim 5 (depends on 4) The method of claim 4, wherein the ECG is detected with one or more electrodes located on the implanted pneumatic port. ### Claim 6 (depends on 4) The method of claim 4, wherein the ECG is detected with one or more electrodes located on the implanted pneumatic effector. ### Claim 7 (depends on 4) The method of claim 4, wherein the ECG is detected with the cannula acting as an ECG electrode. ### Claim 8 (depends on 4) The method of claim 4, wherein the ECG is detected with an external electrode. ### Claim 9 (depends on 4) The method of claim 4, further comprising detecting an abnormal cardiac rhythm. ### Claim 10 (depends on 9) The method of claim 9, wherein delivery of the driving gas is stopped when an abnormal cardiac rhythm is detected. ### Claim 11 (depends on 9) The method of claim 9, wherein a rate of one or more of the delivering or withdrawing the driving gas is changed when an abnormal cardiac rhythm is detected. ### Claim 12 (depends on 11) The method of claim 11, wherein the rate is below a rate of the detected cardiac rhythm. ### Claim 13 (depends on 12) The method of claim 12, wherein the rate is a predetermined fixed rate. ### Claim 14 (depends on 4) The method of claim 4, further comprising removing the cannula from the access site when an infection of the access site is observed. ### Claim 15 (depends on 14) The method of claim 14, further comprising treating the infection and replacing the cannula. ### Claim 16 (depends on 15) The method of claim 15, wherein the cannula is replaced through a different site to access the implaned port. ### Claim 17 (depends on 16) The method of claim 16, wherein the cannula comprises a needle and the port comprise a needle-penetrable penetrable septum and the different site is a different region on the septum. ### Claim 18 (depends on 4) The method of claim 4, wherein the implanted port is percutaneously accessed with the cannula through a subxiphoid puncture site. ### Claim 19 (depends on 4) The method of claim 4, wherein the pneumatic effector is disposed at a distal portion of a catheter body. ### Claim 20 (depends on 19) The method of claim 19, wherein the pneumatic effector is advanced through a subxiphoid puncture site. ### Claim 21 (depends on 19) The method of claim 19, further comprising advancing the catheter body toward the patient's pericardial sac to deploy an anchoring structure which maintains the pneumatic effector in position within the space beneath the patient's pericardial sac and over a myocardial surface overlying the patient's left ventricle. ### Claim 22 An implantable cardiac assist catheter for use with an external drive unit, said implantable cardiac assist catheter comprising: a catheter body having a proximal end and a distal end, the catheter body being configured to be advanced through a subxiphoid puncture site and then across a patient's left ventricle; a pneumatic effector proximal of the distal end of the catheter body and configured to be implanted to only a space beneath a patient's pericardial sac and over a myocardial surface overlying the patient's left ventricle, wherein the pneumatic effector is further configured to selectively expand and contract within said space, and wherein the pneumatic effector is elliptical shape and has a length configured to extend along a major portion of the ventricular cavity; and an implantable port at the proximal end of the catheter and configured to receive a percutaneously introduced cannula, said port being connected to supply a driving gas received from the cannula through a gas lumen in the catheter body to the pneumatic effector. ### Claim 23 (depends on 22) The implantable cardiac assist catheter of claim 22, further comprising an anchor disposed distally of the pneumatic effector on the catheter body and configured to stabilize the pneumatic effector in position within the space beneath the patient's pericardial sac and over a myocardial surface overlying the patient's left ventricle. ### Claim 24 (depends on 23) The implantable cardiac assist catheter of claim 23, wherein a distal tip of the catheter comprises the anchor. ### Claim 25 (depends on 24) The implantable cardiac assist catheter of claim 24, wherein the distal tip is configured to be advanced through the patient's pericardium. ### Claim 26 (depends on 24) The implantable cardiac assist catheter of claim 24, wherein the anchor comprises an anchoring balloon. ### Claim 27 (depends on 22) The implantable cardiac assist catheter of claim 22, further comprising an anchor disposed distally of the pneumatic effector on the catheter body and configured to be deployed at the patient's pericardial sac to stabilize the pneumatic effector in position within the space beneath the patient's pericardial sac and over a myocardial surface overlying the patient's left ventricle. ### Claim 28 An external drive unit for use with an implantable cardiac assist catheter, said external drive unit comprising: (a) a pump assembly configured to alternately (i) deliver the driving gas to a pneumatic effector of the implantable cardiac assist catheter during cardiac systole to expand the pneumatic effector and (ii) withdraw the driving gas from the pneumatic effector during cardiac diastole to contract the pneumatic effector, wherein the pneumatic effector is configured to be implanted to only a space beneath a patient's pericardial sac and over a myocardial surface overlying the patient's left ventricle, wherein the pneumatic effector is further configured to selectively expand and contract within said space, and wherein the pneumatic effector is elliptical in shape and has a length configured to extend along a major portion of the ventricular cavity; and (b) control circuitry configured to operate the pump assembly to actuate the pneumatic effector on the implantable cardiac assist catheter in synchrony with the patient's cardiac rhythm as measured by an electrocardiogram (ECG). ### Claim 29 (depends on 28) The external drive unit of claim 28, wherein the control circuitry is configured to deliver the driving gas to the pneumatic effector at the start of the QRS complex or R wave peak of the measured ECG. ### Claim 30 (depends on 28) The external drive unit of claim 28, wherein the pneumatic effector is stabilized in position within the space beneath the patient's pericardial sac and over a myocardial surface overlying the patient's left ventricle by an anchor coupled to the pneumatic effector and deployed at the patient's pericardial sac.