# US 10,368,872 B2 · System and method for low profile occlusion balloon catheter > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,368,872 B2 - Document ID: US10368872B2 - Status: Granted - Kind: B2 - Application number: 15/573,054 - Filed: 2017-06-02 - Published: 2019-03-14 - Granted: 2019-08-06 - Earliest claimed: 2016-06-02 - Assignees: Prytime Medical Devices, Inc. - Applicants: Prytime Medical Devices, Inc. - Inventors: Curtis J. Franklin; Todd J. Krummenacher; Jeremy Reynolds; David Spencer; Luke William Fisher - Web page: https://patentgrep.com/patent/US10368872B2 ## CPC - A61B 17/12136: {Balloons} - A61B 17/12036: {partial occlusion} - A61B 17/12109: {in a blood vessel} - A61M 25/00: Catheters; Hollow probes (dilators A61M29/00; {peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00} ; for measuring or testing A61B; {materials for catheters A61L29/00}) - A61M 25/0068: {Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure} - A61M 25/02: Holding devices, e.g. on the body - A61M 25/10: Balloon catheters ({A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02;} inflatable balloons for placing stents or stent-grafts A61F2/958 {; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00}) - A61M 25/1002: {characterised by balloon shape (A61M25/1006, A61M25/1009 take precedence)} - A61M 25/1011: {Multiple balloon catheters} - A61M 25/10184: {Means for controlling or monitoring inflation or deflation} - A61M 25/104: {used for angioplasty} - A61B 2017/22051: {with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation (A61B2017/22048, A61B2017/3486 take precedence)} - A61B 2017/22055: {with three or more balloons} - A61M 2025/0002: {with a pressure sensor at the distal end} - A61M 2025/0003: {having an additional lumen transmitting fluid pressure to the outside for measurement} - A61M 2025/024: {having a clip or clamp system} - A61M 2025/028: {having a mainly rigid support structure} - A61M 2025/0286: {anchored in the skin by suture or other skin penetrating devices} - A61M 2025/1052: {for temporarily occluding a vessel for isolating a sector} - A61M 2025/1056: {having guide wire lumens outside the main shaft, i.e. the guide wire lumen is within or on the surface of the balloon} - A61M 2025/1061: {having separate inflations tubes, e.g. coaxial tubes or tubes otherwise arranged apart from the catheter tube} - A61M 2025/1084: {having features for increasing the shape stability, the reproducibility or for limiting expansion, e.g. containments, wrapped around fibres, yarns or strands} - A61M 2025/1088: {having special surface characteristics depending on material properties or added substances, e.g. for reducing friction} - A61M 2025/1095: {with perfusion means for enabling blood circulation while the balloon is in an inflated state or in a deflated state, e.g. permanent by-pass within catheter shaft} - 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 An occlusion catheter system includes an inflation catheter member and an occlusion balloon. The proximal and distal balloon ends are connected to the inflation catheter between the proximal and distal catheter ends. A distal pressure sensor is attached to the inflation catheter member between the proximal balloon end and the atraumatic tip. An inflatable spine is connected to the inflation catheter. The proximal spine end is connected to the inflation catheter near the proximal balloon end and the distal spine end is connected to the inflation catheter near the distal balloon end. The occlusion balloon and the inflatable spine are configured to define blood flow channels with the internal surface and the external balloon surface when the occlusion catheter system is at least partially positioned in the vessel and the occlusion balloon and the inflatable spine are in a partially inflated configuration. ## Claims ### Claim 1 An occlusion catheter system for occlusion or partial occlusion of a relatively large vessel having an internal surface, the occlusion catheter system comprising: an inflation catheter member having a stiffener member, a first inflation lumen, a proximal catheter end and a distal catheter end, the inflation catheter member defining a longitudinal axis, the inflation catheter member having an atraumatic tip on the distal catheter end; an occlusion balloon having an internal balloon space, an external balloon surface, a proximal balloon end and a distal balloon end, the proximal and distal balloon ends connected to the inflation catheter between the proximal catheter end and the distal catheter end, the occlusion balloon substantially centered along the longitudinal axis in an inflated configuration, the first inflation lumen being in fluid communication with the internal balloon space; a distal pressure sensor attached to the inflation catheter member between the distal balloon end and the atraumatic tip; and an inflatable spine having an internal spine space, an external spine surface, a proximal spine end and a distal spine end, the proximal and distal spine ends connected to the inflation catheter, a portion of the external balloon surface contacting the external spine surface when the occlusion balloon and the inflatable spine are in an inflated configuration, the proximal spine end connected to the inflation catheter near the proximal balloon end and the distal spine end connected to the inflation catheter near the distal balloon end, the occlusion balloon and the inflatable spine configured to define blood flow channels with the internal surface and the external balloon surface when the occlusion catheter system is at least partially positioned in the vessel and the occlusion balloon and the inflatable spine are in a partially inflated configuration, the inflatable spine has a substantially constant spine diameter between the proximal spine end and the distal spine end in partially and fully inflated configurations. ### Claim 2 (depends on 1) The occlusion catheter system of claim 1 wherein the occlusion balloon has an occlusion diameter, the occlusion diameter being at least twice the spine diameter when the occlusion balloon and the inflatable spine are inflated at a partial inflation pressure. ### Claim 3 (depends on 1) The occlusion catheter system of claim 1, wherein the first inflation lumen is in fluid communication with the inflatable spine. ### Claim 4 (depends on 1) The occlusion catheter system of claim 1, wherein the inflation catheter member includes a second inflation lumen, the second inflation lumen being in fluid communication with the inflatable spine. ### Claim 5 (depends on 1) The occlusion catheter system of claim 1, wherein the occlusion balloon is constructed of a compliant polymeric material and the inflatable spine is constructed of a non-compliant material. ### Claim 6 (depends on 1) The occlusion catheter system of claim 1, wherein the pressure sensor is comprised of an electronic pressure sensor. ### Claim 7 (depends on 1) The occlusion catheter system of claim 1, wherein the pressure sensor is comprised of a distal side port in the inflation catheter member, the stiffener member including a lumen therein, the distal side portion in fluid communication with the lumen in the stiffener member. ### Claim 8 (depends on 7) The occlusion catheter system of claim 7, wherein the stiffener member is comprised of a hypotube and the lumen is comprised of a hypotube lumen. ### Claim 9 (depends on 8) The occlusion catheter system of claim 8, wherein the hypotube is constructed of a nitinol material. ### Claim 10 (depends on 1) The occlusion catheter system of claim 1, wherein the occlusion balloon and the inflatable spine are configured such that the occlusion balloon over-drives and substantially flattens the inflatable spine against the internal surface in the fully inflated configuration. ### Claim 11 (depends on 1) The occlusion catheter system of claim 1, wherein the atraumatic tip is comprised of a generally flattened cylinder having two generally planar opposing surfaces. ### Claim 12 (depends on 1) The occlusion catheter system of claim 1, further comprising: a proximal pressure sensor mounted to the catheter member proximally relative to the occlusion balloon. ### Claim 13 (depends on 12) The occlusion catheter system of claim 12, further comprising: a controller in communication with the proximal and distal pressure sensors; and a pump in fluid communication with the occlusion balloon and the inflatable spine, the controller configured to one of introduce pressurized fluid into the occlusion balloon and the inflatable spine and withdraw fluid from the occlusion balloon and the inflatable spine based on pressure measurements from the proximal and distal pressure sensors. ### Claim 14 (depends on 1) The occlusion catheter system of claim 1, further comprising: a control hub mountable to the catheter member near the proximal catheter end, the control hub including a display screen and a power source, the control hub configured to depict pressure on the display screen from the distal pressure sensor. ### Claim 15 An occlusion catheter system for occlusion or partial occlusion of a relatively large vessel having an internal surface, the occlusion catheter system comprising: an inflation catheter member having a stiffener member, a first inflation lumen, a second inflation lumen, a proximal catheter end and a distal catheter end, the inflation catheter member defining a longitudinal axis, the inflation catheter member having an atraumatic tip on the distal catheter end; an occlusion balloon having an internal balloon space, an external balloon surface, a proximal balloon end and a distal balloon end, the proximal and distal balloon ends connected to the inflation catheter between the proximal catheter end and the distal catheter end, the occlusion balloon substantially centered along the longitudinal axis in an inflated configuration, the first inflation lumen being in fluid communication with the internal balloon space; a distal pressure sensor attached to the inflation catheter member between the proximal balloon end and the atraumatic tip; and an inflatable spine having an internal spine space, an external spine surface, a proximal spine end and a distal spine end, the proximal and distal spine ends connected to the inflation catheter, the internal spine space being in fluid communication with the second inflation lumen, a portion of the external balloon surface contacting the external spine surface when the occlusion balloon and the inflatable spine are in an inflated configuration, the proximal spine end connected to the inflation catheter near the proximal balloon end and the distal spine end connected to the inflation catheter near the distal balloon end, the inflatable spine has a substantially constant spine diameter between the proximal spine end and the distal spine end in partially and fully inflated configurations. ### Claim 16 (depends on 15) The occlusion catheter system of claim 15, wherein the occlusion balloon is constructed of a compliant polymeric material and the inflatable spine is constructed of a non-compliant material. ### Claim 17 (depends on 16) The occlusion catheter system of claim 16, wherein the occlusion balloon is constructed of a compliant first polyurethane material and the inflatable spine is constructed of non-compliant second polyurethane material, the first polyurethane material having a first durometer and the second polyurethane material having a second durometer, the second durometer being greater than the first durometer. ### Claim 18 (depends on 15) The occlusion catheter system of claim 15, wherein the occlusion balloon and the inflatable spine are configured to define blood flow channels with the internal surface and the external balloon surface when the occlusion catheter system is at least partially positioned in the vessel and the occlusion balloon and the inflatable spine are in the partially inflated configuration. ### Claim 19 (depends on 15) The occlusion catheter system of claim 15, wherein the occlusion balloon and the inflatable spine are configured such that the occlusion balloon over-drives and substantially flattens the inflatable spine against the internal surface in the fully inflated configuration. ### Claim 20 (depends on 15) The occlusion catheter system of claim 15, wherein the inflation catheter member includes a stiffener member extending substantially coaxially and substantially defining the longitudinal axis. ### Claim 21 (depends on 20) The occlusion catheter system of claim 20, wherein the stiffener member is comprised of a hypotube. ### Claim 22 (depends on 15) The occlusion catheter system of claim 15, wherein the pressure sensor is comprised of an electronic pressure sensor. ### Claim 23 (depends on 15) The occlusion catheter system of claim 15, further comprising: a proximal pressure sensor mounted to the catheter member proximally relative to the occlusion balloon. ### Claim 24 (depends on 23) The occlusion catheter system of claim 23, further comprising: a controller in communication with the proximal and distal pressure sensors; and a pump in fluid communication with the occlusion balloon and the inflatable spine, the controller configured to one of introduce pressurized fluid into the occlusion balloon and the inflatable spine and withdraw fluid from the occlusion balloon and the inflatable spine based on pressure measurements from the proximal and distal pressure sensors. ### Claim 25 (depends on 15) The occlusion catheter system of claim 15, further comprising: a control hub mountable to the catheter member near the proximal catheter end, the control hub including a display screen and a power source, the control hub configured to depict pressure on the display screen from the distal pressure sensor.