# US 11,077,294 B2 · Sheath assembly for catheter pump > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,077,294 B2 - Document ID: US11077294B2 - Status: Granted - Kind: B2 - Application number: 15/812,471 - Filed: 2017-11-14 - Published: 2018-03-08 - Granted: 2021-08-03 - Earliest claimed: 2013-03-13 - Assignees: Tc1 LLC - Applicants: Tc1 LLC - Inventors: Richard L. Keenan; Keif M. Fitzgerald; Veronica J. Neiman; Phyllis Yuen - Web page: https://patentgrep.com/patent/US11077294B2 ## CPC - A61M 25/0662: {Guide tubes} - A61M 60/13: by means of a catheter allowing explantation, e.g. catheter pumps temporarily introduced via the vascular system - A61M 60/216: including a rotating member acting on the blood, e.g. impeller - A61M 60/411: generated by an electromotor - A61M 60/824: Hydrodynamic or fluid film bearings - A61M 60/867: using position detection during deployment, e.g. for blood pumps mounted on and driven through a catheter - A61M 25/0068: {Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure} - A61M 25/0097: {characterised by the hub (tube connectors or tube couplings A61M39/10)} - A61M 25/0108: {using radio-opaque or ultrasound markers} - A61M 25/0113: {Mechanical advancing means, e.g. catheter dispensers} - A61M 25/09041: {Mechanisms for insertion of guide wires} - A61M 39/06: Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof - A61M 60/148: in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices - A61M 60/414: transmitted by a rotating cable, e.g. for blood pumps mounted on a catheter - A61M 60/422: the force acting on the blood contacting member being electromagnetic, e.g. using canned motor pumps - A61M 60/818: Bearings - A61M 60/829: having a purge fluid supply - 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 In one embodiment, a catheter pump assembly is disclosed. The catheter pump assembly can include an impeller assembly. A catheter body can be coupled with the proximal end of the impeller assembly, the catheter body having a reduced stiffness section disposed proximally of the impeller assembly. A sheath assembly can be configured to be translate over the catheter body relative to the impeller assembly from an impeller assembly delivery position to an impeller assembly deployment position. When the sheath assembly is in the impeller assembly deployment position, a reduction in stiffness is provided between the distal end of the sheath assembly and the impeller assembly. ## Claims ### Claim 1 A catheter pump assembly, comprising: an impeller assembly, having a proximal end and a distal end; a catheter body coupled with the proximal end of the impeller assembly, the catheter body having a reduced stiffness section disposed proximally of the impeller assembly and an increased stiffness section disposed distally to the reduced stiffness section, the increased stiffness section including a portion coupled with the proximal end of the impeller assembly; and a sheath assembly, the sheath assembly configured to be translated over the catheter body relative to the impeller assembly from an impeller assembly delivery position to an impeller assembly deployment position; wherein when the sheath assembly is in the impeller assembly deployment position, a reduction in stiffness is provided between the distal end of the sheath assembly and the impeller assembly. ### Claim 2 (depends on 1) The catheter pump assembly of claim 1, wherein the impeller assembly has a stored configuration and a deployed configuration. ### Claim 3 (depends on 1) The catheter pump assembly of claim 1, wherein the sheath assembly has a stiffness sufficient to cause a restoring force to bear on a vessel contact zone and maintain the position of the catheter pump assembly in the aortic arch when the sheath assembly is in the impeller assembly deployment position. ### Claim 4 (depends on 1) The catheter pump assembly of claim 1, wherein a straight segment of the catheter body is provided between the impeller assembly and a portion of the catheter body that is exposed when the sheath assembly is in the impeller assembly deployment position. ### Claim 5 (depends on 4) The catheter pump assembly of claim 4, wherein a bending zone of the catheter body is provided between the straight segment of the catheter body and the distal end of the sheath assembly when the sheath assembly is in the impeller assembly deployment position. ### Claim 6 A catheter pump assembly, comprising: a pump including an impeller assembly; and a catheter body disposed proximal to and supporting the pump, wherein the catheter body includes relatively hard sections each having a hardness greater than 40 D adjacent to a relatively softer middle section having a hardness less than 40 D such that the middle section is configured to contact a wall of an aorta of a patient. ### Claim 7 (depends on 6) The catheter pump assembly of claim 6, wherein the relatively hard sections and the middle section are disposed near the distal end of the catheter body and proximal the pump. ### Claim 8 (depends on 6) The catheter pump assembly of claim 6, wherein the relatively hard sections and the middle section are located at a position to contact a wall of the descending aorta. ### Claim 9 (depends on 6) The catheter pump assembly of claim 6, wherein the relatively hard sections and the middle section are located at a position to contact a wall of the aortic arch. ### Claim 10 (depends on 6) The catheter pump assembly of claim 6, wherein the relatively hard sections and the middle section are located at a position to contact a wall of the ascending aorta. ### Claim 11 A catheter pump assembly, comprising: a pump including an impeller assembly; a catheter body having a coupling section, a vessel wall contact surface distal to the coupling section and a bending section located between the coupling section and the vessel wall contact surface, the coupling section disposed proximally of and configured to couple with the impeller assembly and having a first stiffness, the vessel wall contact surface having a second stiffness and configured to bear against an outer radius of an aortic arch; and the bending section having a third stiffness lower than the first stiffness and the second stiffness such that loads applied distal the vessel wall contact surface result in flexing at the bending section. ### Claim 12 (depends on 11) The catheter pump assembly of claim 11, wherein the bending section is configured to allow the impeller assembly to be maintained straight during flexing in the bending section. ### Claim 13 (depends on 11) The catheter pump assembly of claim 11, wherein the catheter body comprises an outer sheath and the impeller assembly is coupled to an inner catheter body disposed through a lumen of the outer sheath. ### Claim 14 (depends on 13) The catheter pump assembly of claim 13, wherein the outer sheath comprises a sheath assembly having a multi-layer tubular structure. ### Claim 15 (depends on 14) The catheter pump of claim 14, wherein the sheath assembly comprises a braided structure coupled to or embedded in a polymer material. ### Claim 16 A method, comprising: advancing a distal portion of a catheter assembly including an impeller assembly and a catheter body to a treatment location of a patient; wherein the catheter body has a coupling section, a vessel wall contact surface distal to the coupling section and a bending section located between the coupling section and the vessel wall contact surface, the coupling section disposed proximally of and configured to couple with the impeller assembly and having a first stiffness, the vessel wall contact surface having a second stiffness, and the bending section having a third stiffness lower than the first stiffness and the second stiffness such that loads applied distal the vessel wall contact surface result in flexing at the bending section contacting the vessel wall contact surface of the catheter body with a contact zone of an inner wall of an aorta of the patient to secure at least the distal portion of the catheter assembly against the aorta of the patient, the inner wall being located adjacent to the junction of the ascending aorta and the aortic arch; activating the impeller assembly to pump blood across the aortic valve; and maintaining the contact between the vessel wall contact surface of the catheter body and the contact zone while the impeller assembly is activated. ### Claim 17 (depends on 16) The method of claim 16, wherein the catheter body comprises a sheath assembly disposed over an inner catheter body coupled with the impeller assembly, and further comprising retracting the sheath assembly relative to the impeller assembly to permit the impeller assembly to expand to a larger size when across the aortic valve. ### Claim 18 (depends on 17) The method of claim 17, further comprising prior to retracting, positioning a first radiopaque marker on the sheath assembly distal of the aortic valve. ### Claim 19 (depends on 18) The method of claim 18, further comprising positioning a second radiopaque marker disposed proximal of the first radiopaque marker adjacent to an aortic valve of the patient to position an inlet of the impeller assembly distal of the aortic valve and an outlet of the impeller assembly proximal of the aortic valve. ### Claim 20 (depends on 18) The method of claim 18, further comprising releasing a clamp configured to prevent relative movement between the sheath assembly to the impeller assembly prior to retracting the sheath assembly and engaging the clamp to prevent relative movement between the sheath assembly to the impeller assembly after contacting the outer surface of the sheath assembly with the contact zone of the inner wall of the aorta.