# US 2024/0197346 A1 · Pulsatile Balloon Catheter Systems and Methods of Using the Same > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2024/0197346 A1 - Document ID: US20240197346A1 - Status: Published application - Kind: A1 - Application number: 18/593,795 - Filed: 2024-03-01 - Published: 2024-06-20 - Earliest claimed: 2021-02-04 - Assignees: Amplitude Vascular Systems, Inc. - Applicants: Amplitude Vascular Systems, Inc. - Inventors: Robert Chisena; Hitinder Gurm - Web page: https://patentgrep.com/patent/US20240197346A1 ## CPC - A61B 17/22012: {in direct contact with, or very close to, the obstruction or concrement (for removing obstructions in blood vessels by laser A61B18/245)} - A61M 25/10184: {Means for controlling or monitoring inflation or deflation} - A61M 5/007: {for contrast media} - A61M 25/104: {used for angioplasty} - A61B 2017/00022: {Sensing or detecting at the treatment site} - A61B 2017/00039: {Electric or electromagnetic phenomena other than conductivity, e.g. capacity, inductivity, Hall effect} - A61B 2017/00477: {Coupling (A61B2017/0046 takes precedence)} - A61B 2017/00964: {composite} - A61B 2017/22001: {Angioplasty, e.g. PCTA} - A61B 2017/22038: {with a guide wire} - A61B 2017/22054: {with two balloons} - A61B 2017/22062: {to be filled with liquid} - A61B 2090/063: {for measuring volume} - A61B 2090/064: {for measuring force, pressure or mechanical tension} - A61M 2025/0002: {with a pressure sensor at the distal end} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - 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 Pulsatile balloon catheter systems are provided. Aspects of the systems include: a pulse generator; and a balloon catheter assembly operably connected to the pulse generator. In embodiments, the balloon catheter assembly includes: a proximal connector operably connecting the balloon catheter assembly to the pulse generator and configured to transduce a first pulse energy generated by the pulse generator to a second pulse energy; a distal balloon; and a catheter component, where the catheter component includes a fluidic passage operably positioned between the proximal connector and the distal balloon, which passage is configured to propagate the second pulse energy from the proximal connector along the fluid passage to the distal balloon. Also provided are balloon catheter assemblies and kits that include the same. Also provided are systems and methods for assessing vessel compliance in-vivo. Also provided are systems and methods for determining system state of balloon catheter systems. The systems, assemblies and kits find use in a variety of different applications, including balloon angioplasty applications. ## Claims ### Claim at position 1 1-125. (canceled) ### Claim 126 A pulsatile balloon catheter system, the system comprising: (a) a pulse generator; (b) a proximal connector operably connected to the pulse generator, wherein the proximal connector comprises a proximal chamber and a distal chamber separated by a membrane; and (c) a catheter operably connected to the proximal connector and comprising a distal balloon. ### Claim 127 (depends on 126) The pulsatile balloon catheter system according to claim 126, wherein the proximal chamber is defined by a proximal flange and the distal chamber is defined by a distal flange. ### Claim 128 (depends on 127) The pulsatile balloon catheter system according to claim 127, wherein the proximal flange comprises a proximal port configured to receive pulse energy generated by the pulse generator. ### Claim 129 (depends on 127) The pulsatile balloon catheter system according to claim 127, wherein the distal flange comprises a distal port fluidically coupling the distal chamber with the lumen of the catheter. ### Claim 130 (depends on 126) The pulsatile balloon catheter system according to claim 126, wherein the proximal chamber comprises a gas and the distal chamber comprises a liquid. ### Claim 131 (depends on 126) The pulsatile balloon catheter system according to claim 126, wherein the proximal connector comprises a membrane positional sensor configured to detect changes in membrane position of the membrane. ### Claim 132 (depends on 131) The pulsatile balloon catheter system according to claim 131, wherein the membrane positional sensor comprises a Hall Sensor. ### Claim 133 (depends on 132) The pulsatile balloon catheter system according to claim 132, wherein the pulse generator comprises a fixed magnet positioned to modulate voltage of the Hall Sensor upon membrane movement. ### Claim 134 (depends on 126) The pulsatile balloon catheter system according to claim 126, wherein the proximal connector further comprises an electrical assembly. ### Claim 135 (depends on 126) The pulsatile balloon catheter system according to claim 126, wherein the proximal connector further comprises an electrical connector electrically coupling the electrical assembly to the pulse generator. ### Claim 136 (depends on 126) The pulsatile balloon catheter system according to claim 126, wherein pulse generator is configured to generate pneumatic pulse energy. ### Claim 137 (depends on 126) The pulsatile balloon catheter system according to claim 126, wherein the pulse generator comprises a hand-held actuator operably connected to the proximal connector. ### Claim 138 (depends on 126) The pulsatile balloon catheter system according to claim 126, wherein the pulse generator is reusable. ### Claim 139 (depends on 126) The pulsatile balloon catheter system according to claim 126, wherein the proximal connector and catheter are configured for single use. ### Claim 140 (depends on 126) The pulsatile balloon catheter system according to claim 126, wherein the catheter comprises: a proximal flexible tube; a distal catheter shaft; and a connector connecting the distal end of the proximal flexible tube to the proximal end of the distal catheter shaft. ### Claim 141 (depends on 140) The pulsatile balloon catheter system according to claim 140, wherein the connector comprises a first branch configured to provide guidewire access to a guidewire channel of the catheter shaft and a second branch configured to fluidically couple lumens of the proximal flexible tube and distal catheter shaft. ### Claim 142 (depends on 141) The pulsatile balloon catheter system according to claim 141, wherein the connector is a Y connector. ### Claim 143 A balloon catheter assembly comprising: (a) a proximal connector configured to operably connect to a pulse generator, wherein the proximal connector comprises a proximal chamber and a distal chamber separated by a membrane; and (b) a catheter operably connected to the proximal connector and comprising a distal balloon. ### Claim 144 (depends on 143) The balloon catheter assembly according to claim 143, wherein the proximal chamber is defined by a proximal flange and the distal chamber is defined by a distal flange. ### Claim 145 (depends on 144) The balloon catheter assembly according to claim 144, wherein the proximal flange comprises a proximal port configured to receive pulse energy generated by the pulse generator. ### Claim 146 (depends on 144) The balloon catheter assembly according to claim 144, wherein the distal flange comprises a distal port fluidically coupling the distal chamber with the fluidic passage. ### Claim 147 (depends on 143) The balloon catheter assembly according to claim 143, wherein the proximal chamber comprises a gas and the distal chamber comprises a liquid. ### Claim 148 (depends on 143) The balloon catheter assembly according to claim 143, wherein the proximal connector comprises a membrane positional sensor configured to detect changes in membrane position of the membrane. ### Claim 149 (depends on 148) The balloon catheter assembly according to claim 148, wherein the membrane positional sensor comprises a Hall Sensor. ### Claim 150 (depends on 143) The balloon catheter assembly according to claim 143, wherein the proximal connector further comprises an electrical assembly. ### Claim 151 (depends on 150) The balloon catheter assembly according to claim 150, wherein the proximal connector further comprises an electrical connector electrically coupling the electrical assembly to the pulse generator. ### Claim 152 (depends on 143) The balloon catheter assembly according to claim 143, wherein the balloon catheter assembly is configured for single use. ### Claim 153 (depends on 143) The balloon catheter assembly according to claim 143, wherein the catheter comprises: a proximal flexible tube; a distal catheter shaft; and a connector connecting the distal end of the proximal flexible tube to the proximal end of the distal catheter shaft. ### Claim 154 (depends on 153) The balloon catheter assembly according to claim 153, wherein the connector comprises a first branch configured to provide guidewire access to a guidewire channel of the catheter shaft and a second branch configured to fluidically couple lumens of the proximal flexible tube and distal catheter shaft. ### Claim 155 (depends on 154) The balloon catheter assembly according to claim 154, wherein the connector is a Y connector.