METHOD FOR MANUFACTURING CRYOGENIC BALLOON FOR INTRAVASCULAR CATHETER SYSTEM

    公开(公告)号:WO2019023185A1

    公开(公告)日:2019-01-31

    申请号:PCT/US2018/043410

    申请日:2018-07-24

    Abstract: A method for manufacturing a cryogenic balloon (236) for an intravascular catheter system (210) includes the steps of forming the cryogenic balloon (236); and pressurizing the cryogenic balloon (236) before insertion of the cryogenic balloon (236) into a body of a patient (212). The step of pressurizing can occur before or after the cryogenic balloon (236) is bonded (e.g., heat-bonded or adhesive-bonded) to a catheter shaft (234). Additionally, the step of pressurizing can occur at any suitable inflation pressure, i.e. at, below or above a normal operating pressure range of between approximately 2.5 psig and 7.5 psig), and at any suitable temperature, i.e. at, above or below 23 degrees Celsius. The method can further include the step of sterilizing the cryogenic balloon (236), with the step of pressurizing occurring before or after the step of sterilizing.

    COMPENSATION ASSEMBLY FOR FLUID INJECTION LINE OF INTRAVASCULAR CATHETER SYSTEM

    公开(公告)号:WO2019108987A1

    公开(公告)日:2019-06-06

    申请号:PCT/US2018/063396

    申请日:2018-11-30

    Abstract: A fluid injection line compensation assembly for an intravascular catheter system including a balloon catheter having a guidewire lumen and a cryoballoon, includes a fluid injection line, a proximal fluid injection line stop, and a distal fluid injection line stop. The fluid injection line has a fluid discharge region positioned within the cryoballoon. The fluid discharge region includes a fluid port so that cryogenic fluid can be distributed from the fluid injection line to within the cryoballoon. The fluid discharge region is not affixed to the guidewire lumen. The proximal fluid injection line stop is positioned adjacent to the guidewire lumen, the proximal fluid injection line stop being positioned within the cryoballoon. The distal fluid injection line stop is positioned adjacent to the guidewire lumen so that the fluid discharge region is positioned between the proximal fluid injection line stop and the distal fluid injection line stop.

    CRYOGENIC BALLOON WITH GREATER SIZE ADJUSTABILITY AT LOWER INFLATION PRESSURES

    公开(公告)号:WO2019050617A1

    公开(公告)日:2019-03-14

    申请号:PCT/US2018/040908

    申请日:2018-07-05

    Abstract: A balloon catheter (218) for an intravascular catheter system (210) includes a cryogenic balloon (236) that is formed from a blend of polyurethane and polyamide block copolymer. The percentages of polyurethane and polyamide block copolymer can vary. For example, the cryogenic balloon (236) can be formed from greater than 50% polyurethane and less than 50% polyamide block copolymer; greater than 75% polyurethane and less than 25% polyamide block copolymer; or approximately 85% polyurethane and approximately 15% polyamide block copolymer. Additionally, a ratio of a change in inflation pressure (in psi) to a change in outer diameter (in mm) of the cryogenic balloon (236), and a ratio of outer diameter (in mm) of the cryogenic balloon (236) to inflation pressure (in psig) can be varied to form the desired cryogenic balloon (236).

    CRYOBALLOON DEFLATION ASSEMBLY AND METHOD
    4.
    发明申请

    公开(公告)号:WO2018222372A1

    公开(公告)日:2018-12-06

    申请号:PCT/US2018/032355

    申请日:2018-05-11

    Inventor: HARMOUCHE, Chadi

    Abstract: A cryoballoon deflation assembly (326) for an intravascular catheter system (31 0) for use during a cryoablation procedure includes a first deflation initiator (353) and a first deflation initiator inhibitor (354). The first deflation initiator (353) is configured to automatically activate a vacuum pump (325) to deflate a cryoballoon (331, 332) upon completion of a stage of the cryoablation procedure. The first deflation initiator inhibitor (354) is manually changeable to between an activated and deactivated state. When in the activated state, the first deflation initiator inhibitor (354) is configured to inactivate the first deflation initiator (353). The cryoballoon deflation assembly (326) can further include a second deflation initiator (355). The second deflation initiator (355) is manually changeable between an activated and deactivated state. When in the activated state, the second deflation initiator (355) is triggered to activate the vacuum pump (325) to deflate the cryoballoon (331, 332).

    RESIDUAL FLUID MEASUREMENT SYSTEM AND METHOD

    公开(公告)号:WO2019161015A1

    公开(公告)日:2019-08-22

    申请号:PCT/US2019/017945

    申请日:2019-02-14

    Inventor: HARMOUCHE, Chadi

    Abstract: A cryoablation system comprises a balloon catheter including a cryoballoon, and a fluid container configured to supply cryogenic fluid to the cryoballoon and to store a residual fluid quantity. A first fluid sensor senses the residual fluid quantity and generates a first sensor output. A second fluid sensor senses fluid consumption information representing an amount of fluid consumption by the balloon catheter during one or more ablation procedures, and generates a second sensor output. A controller receives the first sensor output and the second sensor output and determines residual cryoablation information based at least in part on the first sensor output and the second sensor output.

    METHOD FOR CONTROLLING PRESSURE WITHIN INFLATABLE BALLOON OF INTRAVASCULAR CATHETER SYSTEM

    公开(公告)号:WO2019040180A1

    公开(公告)日:2019-02-28

    申请号:PCT/US2018/039511

    申请日:2018-06-26

    Inventor: HARMOUCHE, Chadi

    Abstract: A method for controlling a balloon pressure of an inflatable balloon (230) of an intravascular catheter system (210) includes the steps of (i) sending sensor output to a controller (240), the sensor output being based at least partially on the balloon pressure, and (ii) maintaining the balloon pressure within a predetermined pressure range based at least partially upon the sensor output received by the controller (240). The step of maintaining includes one of (a) adjusting a flow rate of a cryogenic fluid (227) through the inflatable balloon (230) while moving the inflatable balloon (230) from a first treatment site (235A) to a second treatment site (235B), and (b) adjusting the flow rate of the cryogenic fluid (227) that is selectively delivered from the fluid source (216) to the inflatable balloon (230) through an adjunct fluid injection line (444) that is in fluid communication with a fluid exhaust line (429).

    GRAPHICAL DISPLAY FOR INTRAVASCULAR CATHETER SYSTEM

    公开(公告)号:WO2019005501A1

    公开(公告)日:2019-01-03

    申请号:PCT/US2018/037663

    申请日:2018-06-14

    Inventor: HARMOUCHE, Chadi

    Abstract: An intravascular catheter system (10) for treating a patient (12) during an ablation procedure includes a graphical display (24) that is configured to display a compilation of data including information regarding at least one of (i) thoracic movement of the patient (12) indicative of operation of a phrenic nerve of the patient (12), (ii) a temperature rate change of a cryogenic fluid (26) within the patient (12), (iii) a target ablation temperature, (iv) a summary that includes one or more ablation locations, a number of ablations at each location and a duration of each ablation at each location, (v) a selection process for determining the ablation location, and (vi) a selection process to specify one or more of the target ablation temperature and the ablation location.

    PHRENIC NERVE STIMULATOR, AND SYSTEM AND METHOD FOR MONITORING PHRENIC NERVE STIMULATION

    公开(公告)号:WO2018212840A1

    公开(公告)日:2018-11-22

    申请号:PCT/US2018/025878

    申请日:2018-04-03

    Abstract: A phrenic nerve pacing monitor assembly (28) for a cryogenic balloon catheter system (10) used during a cryoablation procedure, which monitors movement of a diaphragm (42) of a patient (12), includes a pacing detector (36) and a safety system (40). The pacing detector (36) directly monitors movement of the diaphragm (42) of the patient (12) to detect when phrenic nerve pacing is occurring. Additionally, the pacing detector (36) generates monitor output based on the movement of the diaphragm (42) of the patient (12). The safety system (40) receives the monitor output and based at least in part on the monitor output selectively provides an alert when movement of the diaphragm (42) of the patient (12) is atypical. The safety system (40) is configured to provide the alert only while at least one of (i) phrenic nerve pacing is occurring, and (ii) cryoablation is occurring.

    CRYOGENIC BALLOON CATHETER SYSTEM WITH SENSOR ASSEMBLY

    公开(公告)号:WO2018144483A1

    公开(公告)日:2018-08-09

    申请号:PCT/US2018/016026

    申请日:2018-01-30

    Abstract: An intravascular catheter system for treating a condition in a body includes a catheter shaft, a first inflatable balloon and a plurality of electrodes. The first inflatable balloon is positioned near a distal end of the catheter shaft. The first inflatable balloon moves between an inflated state and a substantially deflated state. In the inflated state, the first inflatable balloon has a maximum circumference. The plurality of electrodes are attached to the first inflatable balloon away from the maximum circumference of the first inflatable balloon. In some embodiments, the plurality of electrodes are attached to the inner surface of the first inflatable balloon. In various embodiments, the intravascular catheter system can also include two or more flex circuits that substantially face one another when the first inflatable balloon is in the substantially deflated state.

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