# US 10,869,989 B2 · Heat exchange catheters and their methods of manufacture and use > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,869,989 B2 - Document ID: US10869989B2 - Status: Granted - Kind: B2 - Application number: 15/350,918 - Filed: 2016-11-14 - Published: 2017-06-29 - Granted: 2020-12-22 - Earliest claimed: 2011-09-30 - Assignees: Zoll Circulation, Inc. - Applicants: ZOLL Circulation, Inc. - Inventors: Jeremy Thomas Dabrowiak - Web page: https://patentgrep.com/patent/US10869989B2 ## CPC - A61M 25/0026: {Multi-lumen catheters with stationary elements (catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175)} - A61F 7/0085: {Devices for generating hot or cold treatment fluids} - A61F 7/12: Devices for heating or cooling internal body cavities - A61M 25/0015: {Making lateral openings in a catheter tube, e.g. holes, slits, ports, piercings of guidewire ports; Methods for processing the holes, e.g. smoothing the edges} - A61M 25/007: {Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked} - A61M 25/09: Guide wires - A61F 2007/0054: {with a closed fluid circuit, e.g. hot water} - A61F 2007/0056: {for cooling} - A61F 2007/0096: {with a thermometer} - A61F 2007/0098: {ways of manufacturing heating or cooling devices for therapy} - A61F 2007/0261: {medicated} - A61F 2007/126: {for invasive application, e.g. for introducing into blood vessels} - A61M 2025/0183: {Rapid exchange or monorail catheters} - Y10T 29/49826: Assembling or joining - 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)} - A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C) - Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION ## Abstract A closed loop catheter useable for heat exchange is manufactured by forming a plurality of generally transverse bore holes though a flexible, multilumen catheter body, lacing a tube trough the bore holes so that loops of the tube protrude from the catheter body, connecting one end of the tube to an inflow lumen of the catheter and connecting the other end of the tube to an outflow lumen of the catheter. A heated or cooled heat exchange medium may then be circulated through the tube while the catheter is inserted in the vasculature of a subject, thereby resulting in heat exchange between the subject's flowing blood and the heat exchange medium being circulated through the tube. ## Claims ### Claim 1 A catheter device comprising: an elongate body having a proximal portion and a distal portion; the proximal portion of the elongate body having an inflow lumen and an outflow lumen; a tube passing through a series of spaced apart locations on the distal portion such that the tube forms a series of loops that protrude outwardly from the distal portion; the tube having a first end connected to the inflow lumen and a second end connected to the outflow lumen; wherein transverse openings are formed at the spaced apart locations on the elongate body and the tube is positioned through those transverse openings, and wherein the transverse openings are formed at the spaced apart locations and the tube is threaded through those transverse openings. ### Claim 2 (depends on 1) A catheter device according to claim 1 further comprising a through lumen useable for at least one purpose selected from a) facilitating advancement of the catheter device over a guidewire and/or b) as a passageway for delivery of a therapeutic substance or device through the catheter device and into a subject's body. ### Claim 3 (depends on 1) A catheter device according to claim 1 wherein the loops are generally U shaped. ### Claim 4 (depends on 1) A catheter device according to claim 1, wherein the tube has a wall thickness of approximately 0.001 inch. ### Claim 5 (depends on 1) A catheter device according to claim 1 wherein the tube will withstand pressures of up to about 100 psi. ### Claim 6 (depends on 1) A catheter device according to claim 1 wherein the tube is formed of a rigid or semi-rigid material that will undergo only limited expansion in response to fluid pressure within the tube. ### Claim 7 (depends on 1) A catheter device according to claim 1 wherein the tube is formed of a polyethylene terephthalate or polyether block amide material. ### Claim 8 (depends on 1) A catheter device according to claim 1 wherein: a window into the inflow lumen is formed at a first location and the first end of the tube extends through that window into the inflow lumen and is affixed to a wall of the inflow lumen; and a window into the outflow lumen is formed at a second location and the second end of the tube extends through that window into the outflow lumen and is affixed to a wall of the outflow lumen. ### Claim 9 (depends on 8) A catheter device according to claim 8 wherein the window into the outflow lumen is located distal to the window into the inflow lumen such that fluid will progress through the loops in a distal direction. ### Claim 10 (depends on 8) A catheter device according to claim 8 wherein the window into the outflow lumen is located proximal to the window into the inflow lumen such that fluid will progress through the loops in a proximal direction. ### Claim 11 (depends on 1) A system comprising a catheter device according to claim 1 in combination with an apparatus for circulating heated or cooled thermal exchange fluid though the catheter device. ### Claim 12 (depends on 11) A system according to claim 11 wherein the apparatus for circulating heated or cooled thermal exchange fluid comprises a controller which controls temperature and/or flowrate of thermal exchange fluid that is circulated through the catheter device. ### Claim 13 (depends on 12) A system according to claim 12 wherein the controller receives a) an input target body temperature and b) signals from a temperature sensor indicative of a sensed body temperature and wherein the controller is programmed to vary the temperature and/or flowrate of the thermal exchange fluid in a manner that causes or attempts to cause the sensed body temperature to be the same as or within an acceptable range of the target body temperature. ### Claim 14 A catheter device comprising: an elongate body having a proximal portion and a distal portion; the proximal portion of the elongate body having an inflow lumen and an outflow lumen; a tube passing through a series of spaced apart locations on the distal portion such that the tube forms a series of loops that protrude outwardly from the distal portion; the tube having a first end connected to the inflow lumen and a second end connected to the outflow lumen; wherein a window into the inflow lumen is formed at a first location and the first end of the tube extends through that window into the inflow lumen and is affixed to a wall of the inflow lumen; and a window into the outflow lumen is formed at a second location and the second end of the tube extends through that window into the outflow lumen and is affixed to a wall of the outflow lumen. ### Claim 15 (depends on 14) A catheter device according to claim 14 wherein the window into the outflow lumen is located distal to the window into the inflow lumen such that fluid will progress through the loops in a distal direction. ### Claim 16 (depends on 14) A catheter device according to claim 14 wherein the window into the outflow lumen is located proximal to the window into the inflow lumen such that fluid will progress through the loops in a proximal direction. ### Claim 17 A catheter device comprising: an elongate body having a proximal portion and a distal portion; the proximal portion of the elongate body having an inflow lumen and an outflow lumen; a tube passing through a series of spaced apart locations on the distal portion such that the tube forms a series of loops that protrude outwardly from the distal portion; the tube having a first end connected to the inflow lumen and a second end connected to the outflow lumen; wherein the first and second ends of the tube are secured to inflow and outflow lumens, respectively, by adhesive. ### Claim 18 A system comprising: a catheter device which comprises; an elongate body having a proximal portion and a distal portion, the proximal portion of the elongate body having an inflow lumen and an outflow lumen and a tube passing through a series of spaced apart locations on the distal portion such that the tube forms a series of loops that protrude outwardly from the distal portion; the tube having a first end connected to the inflow lumen and a second end connected to the outflow lumen; wherein transverse openings are formed at said spaced apart locations on the elongate body and the tube is positioned through those transverse openings; and wherein transverse openings are formed at said spaced apart locations and the tube is threaded through those transverse openings in combination with: apparatus for circulating heated or cooled thermal exchange fluid through the catheter device. ### Claim 19 (depends on 18) A system according to claim 18, wherein the apparatus for circulating heated or cooled thermal exchange fluid comprises a controller which controls temperature and/or flowrate of the thermal exchange fluid that is circulated through the catheter device. ### Claim 20 (depends on 19) A system according to claim 19 wherein the controlled receives a) an input target body temperature and b) signals from a temperature sensor indicative of a sensed body temperature and wherein the controller is programmed to vary the temperature and/or flow rate of the thermal exchange fluid in a manner that causes or attempts to cause the sensed body temperature to be the same as or within an acceptable range of the target body temperature. ### Claim 21 (depends on 18) A system according to claim 18 wherein the catheter device further comprises a through lumen useable for at least one purpose selected from a) facilitating advancement of the catheter device over a guidewire and/or b) as a passageway for delivery of a therapeutic substance or device through the catheter device and into a subject's body. ### Claim 22 (depends on 18) A system according to claim 18 wherein the loops are generally U shaped. ### Claim 23 (depends on 18) A system according to claim 18 wherein the tube has a wall thickness of approximately 0.001 inch. ### Claim 24 (depends on 18) A system 1 according to claim 18 wherein the tube will withstand pressures of up to about 100 psi. ### Claim 25 (depends on 18) A system according to claim 18 wherein the tube is formed of a rigid or semi-rigid material that will undergo only limited expansion in response to fluid pressure within the tube. ### Claim 26 (depends on 18) A system according to claim 18 wherein the tube is formed of a polyethylene terephthalate or polyether block amide material.