Abstract: A method and system for controlling flow of refrigerant through a medical device are disclosed. According to one aspect, a system for delivering refrigerant to an expansion cavity portion of the medical device comprises a first path and a second path in communication with the expansion cavity portion. The system also includes a first PID controller in communication with a first proportional valve in the first path, the first PID controller being configured to operate the first proportional valve based on a pressure measurement in the first path; and a second PID controller in communication with a second proportional valve in the second path, the second controller being configured to operate the second proportional valve based on a pressure measurement in the second path or in the expansion cavity portion.

Abstract: A system and method for providing greater control over the temperature of a thermal treatment element of a medical device, enabling an operator to extend a thawing period of a cryoablation procedure. The system may include a fluid flow path that bypasses a subcooler, giving the operator selective control over the temperature of refrigerant delivered to the treatment element and, therefore, treatment element temperature. Additionally or alternatively, the system may include a fluid delivery conduit that is in communication with a liquid refrigerant and a gaseous refrigerant. Adjustment of the ratio of liquid to gaseous refrigerant also offers control over the treatment element temperature. Additionally or alternatively, the system may include one or more valves and/or heating elements in the fluid delivery and recovery conduits to control the treatment element temperature.

Abstract: A system and kit for using a source of low-pressure refrigerant for a cryotherapy procedure and for subcooling a cryotherapy refrigerant. The system may generally include a fluid reservoir and a fluid flow path in thermal exchange with the fluid reservoir, the fluid flow path including a first thermal exchange device in thermal exchange with the fluid reservoir, a compressor in fluid communication with the first thermal exchange device, a condenser, a reversing valve located between the compressor and the condenser, a second thermal exchange device located between the reversing valve and the compressor, and an expansion valve located between the condenser and the thermal exchange device. The third thermal exchange device may be configured to be in fluid communication with the cryotherapy console and configured to place a secondary refrigerant within the first fluid flow path in thermal communication with a secondary refrigerant of the cryotherapy system.

Abstract: A system and method of using a source of low-pressure refrigerant for a cryotherapy procedure. The system may generally include a fluid reservoir and a fluid flow path in thermal exchange with the fluid reservoir, the fluid flow path including a thermal exchange device in thermal exchange with the fluid reservoir, a compressor in fluid communication with the thermal exchange device, a condenser, a reversing valve located between the compressor and the condenser, and an expansion valve located between the condenser and the thermal exchange device. The method may include transferring a low-pressure refrigerant to a first fluid reservoir, reducing the temperature of the refrigerant within the first fluid reservoir, increasing the temperature of the refrigerant within the first fluid reservoir, and transferring the pressurized refrigerant from the first fluid reservoir to a second fluid reservoir.

Abstract: A method of ablating tissue includes positioning a treatment device proximate to a target tissue area. The treatment device has an expandable treatment element. The expandable treatment element is inflated with a refrigerant during an inflation phase such that at least a portion of the expandable treatment element is in contact with the target tissue area. A first pressure measurement of the inflated expandable treatment element is recorded and compared to a predetermined pressure threshold. The refrigerant is circulated within the expandable treatment element during an ablation phase to reduce a temperature of the target tissue area to a temperature sufficient to cryoablate the target tissue area. A second pressure measurement of the expandable treatment element is recorded during the ablation phase and compared to the predetermined pressure threshold.

Abstract: A system and method for controlling the inflation, ablation, and deflation of a balloon catheter. The system includes a balloon catheter, a console, a pressurized gas or liquid inflation source, and an umbilical system to deliver pressurized coolant to the balloon catheter. The system may include controller that monitors the amount of pressure and volume within the balloon catheter. During inflation, the pressure and/or volume of fluid within the balloon is maintained at a target amount in order to provide sufficient mechanized pressure against the desired target region. The system limits the inflation pressure such that a safe quantity of gas would be released should a leak occur. If the amount falls below a certain threshold level, gas or fluid egress is presumed and the inflation process is halted.

Abstract: An adapter for putting two incompatible medical systems in fluid communication with each other. The adapter may have a continuous outer diameter and may include two segments: a first segment composed of a rigid material and including a first portion and a second portion, the first portion having a continuous outer diameter and the second portion defining one or more flanges, the first segment defining a first passage therethrough; and a second segment composed of a flexible material and coupled to the first segment, including a first portion and a second portion. The first portion of the second segment may have an inner surface configured to surround the flanges of the second portion of the first segment, and the second portion of the second segment having a tapered inner surface, the second segment defining a second passage therethrough that is continuous with the first passage.

Abstract: A device, system, and method for performing a variety of treatment procedures safely with a single treatment device. For example, a system is provided that includes a treatment device with a highly conformable balloon that is inflated at a constant pressure and that remains “soft” during use, which enhances balloon-tissue contact, treatment efficacy, and patient safety. In one embodiment, a system for ablating tissue comprises: a treatment device including a highly conformable balloon; a control unit including a fluid supply reservoir in fluid communication with the highly conformable balloon, the control unit being configured to deliver fluid from the fluid supply reservoir to the highly conformable balloon such that the highly conformable balloon is maintained at a balloon pressure of between 0.2 psig and 3.0 psig.

Abstract: An adapter for putting two incompatible medical systems in fluid communication with each other. The adapter may have a continuous outer diameter and may include two segments: a first segment composed of a rigid material and including a first portion and a second portion, the first portion having a continuous outer diameter and the second portion defining one or more flanges, the first segment defining a first passage therethrough; and a second segment composed of a flexible material and coupled to the first segment, including a first portion and a second portion. The first portion of the second segment may have an inner surface configured to surround the flanges of the second portion of the first segment, and the second portion of the second segment having a tapered inner surface, the second segment defining a second passage therethrough that is continuous with the first passage.

Abstract: A device, system, and method for performing a variety of treatment procedures safely with a single treatment device. For example, a system is provided that includes a treatment device with a highly conformable balloon that is inflated at a constant pressure and that remains “soft” during use, which enhances balloon-tissue contact, treatment efficacy, and patient safety. In one embodiment, a system for ablating tissue comprises: a treatment device including a highly conformable balloon; a control unit including a fluid supply reservoir in fluid communication with the highly conformable balloon, the control unit being configured to deliver fluid from the fluid supply reservoir to the highly conformable balloon such that the highly conformable balloon is maintained at a balloon pressure of between 0.2 psig and 3.0 psig.

Abstract: A medical system, comprising an ablation catheter is disclosed. The ablation catheter includes an elongate shaft with a proximal end, a distal end and a lumen disposed between the proximal end and the distal end. The ablation catheter also includes an expandable element in fluid communication with the lumen, a first temperature sensor operable to measure a first temperature; and a second temperature sensor operable to measure a second temperature. The first temperature sensor and the second temperature sensor are longitudinally separated from each other by at least a portion of the expandable element.

Abstract: A system and method for providing greater control over the temperature of a thermal treatment element of a medical device, enabling an operator to extend a thawing period of a cryoablation procedure. The system may include a fluid flow path that bypasses a subcooler, giving the operator selective control over the temperature of refrigerant delivered to the treatment element and, therefore, treatment element temperature. Additionally or alternatively, the system may include a fluid delivery conduit that is in communication with a liquid refrigerant and a gaseous refrigerant. Adjustment of the ratio of liquid to gaseous refrigerant also offers control over the treatment element temperature. Additionally or alternatively, the system may include one or more valves and/or heating elements in the fluid delivery and recovery conduits to control the treatment element temperature.

Abstract: A medical system, comprising an ablation catheter is disclosed. The ablation catheter includes an elongate shaft with a proximal end, a distal end and a lumen disposed between the proximal end and the distal end. The ablation catheter also includes an expandable element in fluid communication with the lumen, a first temperature sensor operable to measure a first temperature; and a second temperature sensor operable to measure a second temperature. The first temperature sensor and the second temperature sensor are longitudinally separated from each other by at least a portion of the expandable element.

Abstract: A system and method for providing greater control over the temperature of a thermal treatment element of a medical device, enabling an operator to extend a thawing period of a cryoablation procedure. The system may include a fluid flow path that bypasses a subcooler, giving the operator selective control over the temperature of refrigerant delivered to the treatment element and, therefore, treatment element temperature. Additionally or alternatively, the system may include a fluid delivery conduit that is in communication with a liquid refrigerant and a gaseous refrigerant. Adjustment of the ratio of liquid to gaseous refrigerant also offers control over the treatment element temperature. Additionally or alternatively, the system may include one or more valves and/or heating elements in the fluid delivery and recovery conduits to control the treatment element temperature.

Abstract: A system for the recovery of expanded refrigerant from a cryotreatment system for storage and disposal may generally include first fluid flow path having a first compressor and a fluid recovery reservoir, and a closed-loop second fluid flow path having a thermal exchange device that is in thermal communication with the fluid recovery reservoir, a second compressor, and a condenser. The first fluid flow path may include a primary refrigerant from a cryotreatment system and the closed-loop second fluid flow path may contain a secondary refrigerant for cooling the primary refrigerant within the fluid recovery reservoir. The refrigerant recovery conduit may be in fluid communication with both the cryotreatment system and a medical facility scavenging system. The refrigerant recovery conduit and the cryotreatment system may be located within the same cryotreatment console.

Abstract: A system for the recovery of expanded refrigerant from a cryotreatment system for storage and disposal may generally include first fluid flow path having a first compressor and a fluid recovery reservoir, and a closed-loop second fluid flow path having a thermal exchange device that is in thermal communication with the fluid recovery reservoir, a second compressor, and a condenser. The first fluid flow path may include a primary refrigerant from a cryotreatment system and the closed-loop second fluid flow path may contain a secondary refrigerant for cooling the primary refrigerant within the fluid recovery reservoir. The refrigerant recovery conduit may be in fluid communication with both the cryotreatment system and a medical facility scavenging system. The refrigerant recovery conduit and the cryotreatment system may be located within the same cryotreatment console.

Abstract: A system and method of using a source of low-pressure refrigerant for a cryotherapy procedure. The system may generally include a fluid reservoir and a fluid flow path in thermal exchange with the fluid reservoir, the fluid flow path including a thermal exchange device in thermal exchange with the fluid reservoir, a compressor in fluid communication with the thermal exchange device, a condenser, a reversing valve located between the compressor and the condenser, and an expansion valve located between the condenser and the thermal exchange device. The method may include transferring a low-pressure refrigerant to a first fluid reservoir, reducing the temperature of the refrigerant within the first fluid reservoir, increasing the temperature of the refrigerant within the first fluid reservoir, and transferring the pressurized refrigerant from the first fluid reservoir to a second fluid reservoir.

Abstract: A system and kit for using a source of low-pressure refrigerant for a cryotherapy procedure and for subcooling a cryotherapy refrigerant. The system may generally include a fluid reservoir and a fluid flow path in thermal exchange with the fluid reservoir, the fluid flow path including a first thermal exchange device in thermal exchange with the fluid reservoir, a compressor in fluid communication with the first thermal exchange device, a condenser, a reversing valve located between the compressor and the condenser, a second thermal exchange device located between the reversing valve and the compressor, and an expansion valve located between the condenser and the thermal exchange device. The third thermal exchange device may be configured to be in fluid communication with the cryotherapy console and configured to place a secondary refrigerant within the first fluid flow path in thermal communication with a secondary refrigerant of the cryotherapy system.

Abstract: A system and method of using a source of low-pressure refrigerant for a cryotherapy procedure. The system may generally include a fluid reservoir and a fluid flow path in thermal exchange with the fluid reservoir, the fluid flow path including a thermal exchange device in thermal exchange with the fluid reservoir, a compressor in fluid communication with the thermal exchange device, a condenser, a reversing valve located between the compressor and the condenser, and an expansion valve located between the condenser and the thermal exchange device. The method may include transferring a low-pressure refrigerant to a first fluid reservoir, reducing the temperature of the refrigerant within the first fluid reservoir, increasing the temperature of the refrigerant within the first fluid reservoir, and transferring the pressurized refrigerant from the first fluid reservoir to a second fluid reservoir.

Abstract: A system and kit for using a source of low-pressure refrigerant for a cryotherapy procedure and for subcooling a cryotherapy refrigerant. The system may generally include a fluid reservoir and a fluid flow path in thermal exchange with the fluid reservoir, the fluid flow path including a first thermal exchange device in thermal exchange with the fluid reservoir, a compressor in fluid communication with the first thermal exchange device, a condenser, a reversing valve located between the compressor and the condenser, a second thermal exchange device located between the reversing valve and the compressor, and an expansion valve located between the condenser and the thermal exchange device. The third thermal exchange device may be configured to be in fluid communication with the cryotherapy console and configured to place a secondary refrigerant within the first fluid flow path in thermal communication with a secondary refrigerant of the cryotherapy system.