High-pressure, low-temperature bonding

Abstract

Disclosed herein are devices, systems, and methods for multi-stage reusable coupling. Such couplers can have formable flow paths and can include a first sealing engagement and a second sealing engagement. The first sealing engagement can be configured to provide a first seal of the coupler at a first temperature condition. The second sealing engagement can be configured to provide a second seal of the coupler at a second temperature condition that is different from the first temperature condition.

Description

[Technical field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates to coupling devices, systems and methods, and more particularly to a sealing engagement suitable for coupling a freezing media source to a cryogenic tool. [Background technology]

[0002] Cryoablation of tissue has become an increasingly popular method for the treatment of a variety of pathological conditions. Malignant diseases in organs such as the breast, lung, prostate, kidney, liver, and other organs have been successfully treated by cryoablation, and a variety of non-malignant pathological conditions and certain cases of chronic pain may also be treated by cryosurgery. Summary of the Invention

[0003] Disclosed herein is a coupler having multi-stage sealing. Such couplers are particularly useful in applications where there are dynamic temperature changes within the operating parameters. For example, the exemplary coupler may be useful in connecting a pressurized freezing media source to a cryosurgery tool, a male connector for connecting to a female connector, a female connector for connecting to a male connector, a cryosurgery system, and a method of coupling a freezing media source to a cryogenic tool.

[0004] In one example ("Example 1"), a coupler having a formable flow passage is disclosed. The coupler can include a first sealing engagement and a second sealing engagement. The first sealing engagement can be configured to provide a first seal of the coupler at a first temperature condition. The second sealing engagement can be configured to provide a second seal of the coupler at a second temperature condition, different from the first temperature condition.

[0005] According to another embodiment ("embodiment 2") in addition to embodiment 1, the coupler may include a first connector and a second connector. A formable flow path may be formable via mating of the first connector with the second connector. In this regard, a working medium may flow through the flow path.

[0006] According to another embodiment ("Example 3") in addition to Examples 1 or 2, at least one of the first and second sealing engagements may be provided between complementary surfaces of the first connector and complementary surfaces of the second connector, and optionally, the first connector may have a first coefficient of thermal expansion and the second connector has a second coefficient of thermal expansion different from the first coefficient of thermal expansion.

[0007] According to another embodiment ("Example 4") in addition to Example 3, a first sealing engagement may be provided between a first complementary surface of the first connector and a first complementary surface of the second connector, a second sealing engagement may be provided between a second complementary surface of the first connector and a second complementary surface of the second connector, and optionally, a resilient seal is optionally provided between the second complementary surfaces.

[0008] According to another embodiment ("Example 5") in addition to any of Examples 1-4, the first connector is configured to receive the second connector such that, under a first temperature condition, an outer surface of the first connector engages with an inner surface of the second connector to form at least one of a first engagement portion and a sealing engagement.

[0009] According to another embodiment ("Example 6") in addition to any of Examples 1-5, the first temperature condition can include a first temperature range, and the second temperature condition can include a second temperature range different from the first temperature range, and optionally satisfy at least one of: the first temperature range is lower than the second temperature range; the first temperature range has minimal overlap with the second temperature range; and the first temperature range includes a cryogenic temperature.

[0010] In another embodiment ("Example 7"), a cryosurgical system is disclosed. The cryosurgical system can include a cryosurgical tool having a cryo-medium supply conduit and a cryo-medium source having a cryo-medium feed conduit connectable to the cryo-medium supply conduit via a coupler. The coupler can include a first seal engagement and a second seal engagement. The first seal engagement can be configured to provide a first seal of the coupler at a first temperature condition. The second seal engagement can be configured to provide a second seal of the coupler at a second temperature condition different from the first temperature condition.

[0011] According to another embodiment ("Example 8") in addition to Example 7, the coupler can include a first connector and a second connector, and optionally, a flow path of the coupler can be formed via engagement of the first connector and the second connector. In this regard, the flow path can be configured to receive a cryogenic medium from a cryogenic medium supply conduit.

[0012] According to another embodiment ("Example 9") in addition to Examples 7 or 8, the first temperature condition can include a first temperature range including cryogenic temperatures such that the first sealing engagement is formed at cryogenic temperatures, and optionally, the cryosurgery system includes a heater configured to heat a portion of at least one of the first connector and the second connector. In this regard, the coupler can be configured to be thawed by operation of the heater to release the first sealing engagement.

[0013] According to another embodiment ("Example 10") in addition to any of Examples 7-9, the first connector may have a first coefficient of thermal expansion and the second connector may have a second coefficient of thermal expansion different from the first coefficient of thermal expansion, and optionally the first coefficient of thermal expansion and the second coefficient of thermal expansion are selected to cause first complementary surfaces of the first and second connectors to form a first sealing engagement upon cooling, and / or the second sealing engagement is provided by an elastic seal arranged between second complementary surfaces of the first and second connectors.

[0014] According to another embodiment ("Example 11") in addition to Example 10, the first connector comprises a first fluid conduit and the second connector comprises a second fluid conduit, and the cryosurgery system further comprises a clamp for securing the first and second connectors in a fluid-tight arrangement such that the first conduit is in fluid communication with the second conduit, and a clamp locator for positioning the clamp so that the first and second connectors are aligned.

[0015] In yet another example ("Example 12"), a method of coupling a cryogenic fluid source to a cryosurgery tool using a coupler is disclosed. The method can include sealing the coupler with a first seal via a first seal engagement configured to provide a first seal of the coupler at a first temperature condition. The method can include sealing the coupler with a second seal via a second seal engagement configured to provide a second seal of the coupler at a second temperature condition, different from the first temperature condition.

[0016] According to another embodiment ("Example 13") in addition to Example 12, the step of sealing the coupler with the first seal via a first seal engagement configured to provide a first seal of the coupler at a first temperature condition can include a step of allowing first complementary surfaces of the first and second connectors to move into sealing engagement, optionally, the first connector having a first coefficient of thermal expansion and the second connector having a second coefficient of thermal expansion different from the first coefficient of thermal expansion.

[0017] According to another embodiment ("Example 14") in addition to Example 13, the step of sealing the coupler with a second seal via a second seal engagement configured to provide a second seal of the coupler at a second temperature condition different from the first temperature condition may include forming a fluid seal between second complementary surfaces of the first and second connectors.

[0018] According to another embodiment ("Example 15") in addition to any of Examples 12-14, the method includes clamping the first and second connectors in a fluid-tight arrangement such that a first conduit of the first connector is in fluid communication with a second conduit of the second connector.

[0019] In yet another embodiment ("Example 16"), a coupler having a formable flow passage is disclosed. The coupler can include a first sealing engagement and a second sealing engagement. The first sealing engagement can be configured to provide a first seal of the coupler at a first temperature condition. The second sealing engagement can be configured to provide a second seal of the coupler at a second temperature condition, different from the first temperature condition.

[0020] According to another embodiment ("Example 17") in addition to Example 16, the coupler can include a first connector and a second connector, and optionally a formable flow path can be formed by mating the first connector with the second connector to enable the working medium to flow through the flow path, and the first and second temperature conditions correspond to the flow of the working medium through the flow path.

[0021] According to another embodiment ("embodiment 18") in addition to embodiment 17, the first sealing engagement may be provided between first complementary surfaces of the first and second connectors. According to another embodiment ("embodiment 19") in addition to embodiment 18, a second sealing engagement may be provided between second complementary surfaces of the first and second connectors.

[0022] According to another embodiment ("embodiment 20") in addition to embodiment 18, a resilient seal may be provided between the second complementary surfaces. According to another example ("Example 21") in addition to Example 17, the first connector can be configured to receive the second connector such that under a first temperature condition, an outer surface of the first connector engages an inner surface of the second connector to form a first sealed engagement.

[0023] According to another example ("Example 22") in addition to Example 16, the first temperature condition can include a first temperature range, and the second temperature condition can include a second temperature range that is different from the first temperature range.

[0024] In addition to Example 22, another example ("Example 23") satisfies at least one of the following: the first temperature range is lower than the second temperature range; and the first temperature range has minimal overlap with the second temperature range.

[0025] According to another embodiment ("embodiment 24") in addition to embodiment 23, the first temperature range can include a cryogenic temperature. According to another example ("Example 25") in addition to Example 17, the first connector may have a first coefficient of thermal expansion, and optionally, the second connector has a second coefficient of thermal expansion different from the first coefficient of thermal expansion.

[0026] According to another embodiment ("Example 26") in addition to Example 16, the first connector can be connectable to the second connector via a clamping force such that the formable flow path is configured to withstand high pressure operating conditions.

[0027] In yet another embodiment ("Example 27"), a cryosurgical system is disclosed. The cryosurgical system can include a cryosurgical tool having a cryo-medium supply conduit and a cryo-medium source having a cryo-medium feed conduit connectable to the cryo-medium supply conduit via a coupler. The coupler can include a first seal engagement and a second seal engagement. The first seal engagement can be configured to provide a first seal of the coupler at a first temperature condition. The second seal engagement can be configured to provide a second seal of the coupler at a second temperature condition different from the first temperature condition.

[0028] According to another embodiment ("Example 28") in addition to Example 26, the coupler can include a first connector and a second connector, and optionally, a flow path of the coupler can be formed via engagement of the first connector and the second connector, the flow path being configured to receive a cryogenic medium from a cryogenic medium supply conduit.

[0029] According to another embodiment ("Example 29") in addition to Example 29, the first temperature condition includes a first temperature range including cryogenic temperatures such that the first sealing engagement is formed at cryogenic temperatures, the cryosurgery system further includes a heater configured to heat a portion of at least one of the first connector and the second connector, and the coupler is configured to be thawed by operation of the heater to release the first sealing engagement.

[0030] According to another embodiment ("Example 30") in addition to Example 28, the first connector has a first coefficient of thermal expansion, the second connector has a second coefficient of thermal expansion different from the first coefficient of thermal expansion, the first coefficient of thermal expansion and the second coefficient of thermal expansion selected to cause first complementary surfaces of the first and second connectors to form a first sealing engagement upon cooling, and the second sealing engagement is provided by an elastic seal arranged between the second complementary surfaces of the first and second connectors.

[0031] According to another embodiment ("Example 31") in addition to Example 28, the first connector comprises a first fluid conduit and the second connector comprises a second fluid conduit, and the cryosurgery system further comprises a clamp for securing the first and second connectors in a fluid-tight arrangement such that the first conduit is in fluid communication with the second conduit, and a clamp locator for positioning the clamp so that the first and second connectors are aligned.

[0032] In yet another example ("Example 32"), a method of coupling a cryogenic fluid source to a cryosurgery tool using a coupler is disclosed. The method can include sealing the coupler with a first seal via a first seal engagement configured to provide a first seal of the coupler at a first temperature condition. The method can include sealing the coupler with a second seal via a second seal engagement configured to provide a second seal of the coupler at a second temperature condition, different from the first temperature condition.

[0033] According to another example ("Example 33") in addition to Example 32, the step of sealing the coupler with the first seal via a first seal engagement configured to provide a first seal of the coupler at a first temperature condition can include a step of allowing first complementary surfaces of the first and second connectors to move into sealing engagement, optionally, the first connector has a first coefficient of thermal expansion and the second connector has a second coefficient of thermal expansion different from the first coefficient of thermal expansion.

[0034] According to another embodiment ("Example 34") in addition to Example 33, the step of sealing the coupler with a second seal via a second seal engagement configured to provide a second seal of the coupler at a second temperature condition different from the first temperature condition may include forming a fluid seal between second complementary surfaces of the first and second connectors.

[0035] According to another embodiment ("Example 35") in addition to Example 34, the method further includes a step of clamping the first and second connectors in a fluid-tight arrangement such that a first conduit of the first connector is in fluid communication with a second conduit of the second connector.

[0036] While multiple embodiments are disclosed, still other embodiments of the present invention will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the invention. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive. [Brief description of the drawings]

[0037] [Figure 1] 1 is a schematic diagram of a magnetic resonance imaging guided cryosurgery system in accordance with the principles of the present disclosure; [Diagram 2] FIG. 2 is a plan view of the cryoprobe. [Figure 2A] FIG. 2B is a cross-sectional plan view of detail A of FIG. 2A. [Diagram 3] FIG. 2B is a cross-sectional plan view of a portion of a connection interface that allows connection of the cryoprobe of FIG. 2A. [Figure 3A] FIG. 2 is a schematic plan view of a coupler in accordance with the principles of the present disclosure; [Figure 3B] 1 is a schematic plan view of a coupler having a multi-part connector in accordance with the principles of the present disclosure; FIG. [Figure 3C] FIG. 1 is a schematic plan view of a coupler with a connected valve in accordance with the principles of the present disclosure; [Figure 3D] 2 is a schematic plan view of the coupler of FIG. 1 with a clamp for securing the connector of the coupler in accordance with the principles of the present disclosure; FIG. [Figure 3E] 4 is a schematic plan view of the coupler of FIG. 3 with a clamp for securing the connectors of the coupler in accordance with the principles of the present disclosure. [Figure 4] 1 is a flow diagram of a method for coupling surgical tools in accordance with the principles of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0038] While the invention is susceptible to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and are described in detail below. It is not, however, the intention to limit the invention to the specific embodiments described. On the contrary, the invention is intended to cover all modifications, equivalents, and alternatives falling within the scope of the invention as defined by the appended claims.

[0039] Although the principles of the present disclosure are described below in the context of a cryosurgery environment, these principles are useful across a variety of applications where bonding is required in an environment with dynamic temperatures during operation. However, considering cryosurgery systems as a background, these systems can be used to cryoablate target tissue (e.g., malignant tissue or tumors). Typically, such systems include one or more cryoprobes, one or more sources of freezing medium (e.g., gas or fluid), and a controller. The freezing medium source can provide gases such as argon, nitrogen, air, krypton, C02, CF4, xenon, and various other gases. As used herein, "freezing medium" can refer to any medium (e.g., gas or fluid) that can reach low temperatures (e.g., less than 170 Kelvin). In some non-limiting exemplary embodiments, the medium can reach low temperatures (e.g., less than 170 Kelvin) when pressurized to pressures greater than about 1000 psi (e.g., typically about 3500 psi) and can undergo Joule-Thomson expansion, as further described below. The cryosurgery system may also include a controller having one or more sensors, flow meters, timers, analog to digital converters, wired or wireless communication modules, etc. Additionally, the controller may regulate the flow rate, temperature, and pressure of the freezing medium supplied to the cryoprobe.

[0040] Cryoablation is typically preceded by identifying the site requiring ablation treatment by employing imaging techniques such as x-ray, ultrasound, computed tomography (CT), or magnetic resonance imaging (MRI). Cryoablation is then accomplished by inserting one or more cryoprobes into the site requiring ablation treatment and then cooling the cryoprobes tips of the inserted cryoprobes such that the tissue surrounding the cryoprobes tips is subjected to cryoablation temperatures, typically below 230 Kelvin (e.g., about -40°C) or lower. This technique causes the resulting cooled tissues to lose their functional and structural integrity and, in the case of cancerous cells, to cease growth and proliferation.

[0041] For example, during cryosurgery, a surgeon may deploy one or more cryoprobes to cryoablate a target region of a patient's anatomy by placing the cryoprobes at or near the target region of the patient's anatomy. In one example, the cryoprobes utilize the Joule-Thomson effect to generate cooling or heating. In such cases, a freezing medium expands from high pressure to low pressure within the cryoprobes. The expansion of the freezing medium results in a temperature below that required to cryoablate tissue near the tip of the cryoprobes. Heat transfer between the expanding freezing medium and the outer wall of the cryoprobes can be used to form an ice ball, which results in cryoablation of the tissue.

[0042] FIG. 1 is a schematic diagram of an MRI-guided cryosurgery system 10 according to a non-limiting exemplary embodiment. As shown, the system 10 can include a magnet room 12 having an MRI scanner 14 with an MRI magnet 16 for housing a patient 20. The MRI magnet 16 can be open or closed and can include an access port to allow a surgeon to access the patient 20. The MRI magnet 16 can also have electrical connections 54 (shown in solid lines) and / or mechanical connections (shown in dashed lines) in FIG. 1 for connecting to various electrical systems, control systems, and / or cryoablation systems, as described further below. The system 10 can also include a control room 22 and an equipment room 24 that are electrically (and / or magnetically) isolated (e.g., by electrical and / or magnetic isolation) from the magnet room 12. The system 10 can be used to image the patient 20 prior to insertion of a surgical tool 32 to visualize a region of interest in the patient, such as a tumor or a patient cavity. Additionally, imaging can be performed during insertion to guide the surgical tool to its intended location within the patient 20. Additionally, imaging may be performed after insertion and during surgery, as well as post-operatively.

[0043] 1, in a non-limiting exemplary embodiment, the connection lines 54, 62 may terminate at one or more surgical tools 32, such as a cryoprobe insertable inside the patient 20. Thus, in some such examples, the system 10 may include a connection interface 30 located inside the magnet room 12 to enable connection of one or more surgical tools 32, 34, 36 to other components of the cryoablation system that may be located outside the magnet room 12 (e.g., in the control room 22 or the equipment room 24). For example, the system 10 may include electrical connection lines 54 and fluid connection lines 62 that extend from the control room 22 to the magnet room 12 to operably connect the control system 40 to the surgical tools 32. The connection interface 30 may, in some advantageous examples, be provided on a cart 50 (which may be fixed or mobile) positioned proximate to the magnet to enable direct or indirect (e.g., electrically and / or fluidly) connection of multiple surgical tools 32 to the control system 40 positioned outside the magnet room 12 (e.g., in the control room 22). In the illustrated embodiment, the cart 50 is a mobile cart 50. Further details regarding the connection interface 30 are described in more detail below in conjunction with FIG.

[0044] 1, electrical and fluid connection features between the control system 40 and the surgical tool 32 will be described. The control system 40 can be electrically connected to a junction box 52 located outside the magnet room 12 by a first set of electrical connections 54. Additionally, the junction box 52 can include a second set of electrical connections 56 for connecting to electrical and / or imaging equipment 57 (such as imaging routers and electrical filters) located outside the magnet room 12 (e.g., in the equipment room 24). A third set of electrical connections 58 can connect the electrical and / or imaging equipment 57 to the connection interface 30 and / or mobile cart 50 located inside the magnet room 12. The junction box 52 can enable removable electrical connections between components within the magnet room 12 and components of the electrical room and / or control room.

[0045] Still referring to FIG. 1, in some embodiments, the system 10 may be used to perform a cryosurgery procedure (e.g., cryoablation). Thus, in some embodiments, the system 10 may include one or more cryomedia sources 60. The cryomedia source 60 may be a liquid or gas container capable of providing fluid at cryogenic temperatures and pressure to the surgical tool 32 (e.g., a cryoprobe). The cryomedia source 60 may be a cooling gas such as argon, nitrogen, air, krypton, CF4 xenon, or N2O. As mentioned above, some cryosurgical tools are cryoneedles, which may be connected to one or more cryomedia sources 60 (e.g., a fluid source such as liquid nitrogen or a gas source such as argon) for delivering the cryomedia to one or more cryosurgical tools. After the cryomedia is delivered to the tip of the cryosurgical tool, it is forced under pressure through a Joule-Thomson orifice, which causes the tip to rapidly cool as the cryomedia expands.

[0046] As can be seen in FIG. 1 , the freezing medium source 60 is positioned outside the magnet room 12 and is fluidly connectable to the control system 40 by a first set of fluid connection lines 62. The control system 40 can then be fluidly connected to the connection interface 30 and / or the mobile cart 50 by a second set of fluid connection lines 64 and a third set of fluid connection lines 66. A fourth set of fluid connection lines 68 can fluidly connect the surgical tool 32 (e.g., a cryoprobe) to the connection interface 30 and / or the mobile cart 50. The fluid lines may be flexible and / or removable and may include other fluid components to regulate the pressure of the fluid passing therethrough. Thus, fluid from the freezing medium source 60 can be transported to the surgical tool 32 by the set of fluid connection lines 62, 64, 66, and 68. Optionally, the system 10 can include a fluid connection panel 70 electrically insulated from the magnet room 12 to allow fluid connection between components present in the magnet room 12 and components present in the control room 22. Similarly, the electrical connection panel 72 may facilitate electrical connections between components present within the magnet room 12 and components present within the control room 22 and / or electrical rooms. The illustrated system 10 also includes an MRI display 86 operably coupled to the MRI scanner 14 and positioned within the magnet room 12 for displaying images representative of anatomical features of the patient 20 to provide guidance to the surgeon during surgery.

[0047] As previously described, the surgical tool may be a cryoprobe 100 in a non-limiting exemplary embodiment. FIG. 2 is a front view of such a cryoprobe 100, and FIG. 2A is a cross-sectional front view of the cryoprobe 100 of FIG. 2. With reference to FIGS. 2 and 2A, the cryoprobe 100 may include an elongated body. The components of the cryoprobe 100 may be disposed within a probe shaft 102. The cryoprobe 100 may optionally be a cryoneedle, in which case the components of the cryoneedle may be arranged within a trocar. The probe shaft 102 may terminate in a distal working tip 104 disposed at a distal portion 106 of the cryoprobe 100 for penetrating tissue of the patient 20 during deployment. For example, in the illustrated example, the cryofluid supply tube 112 may terminate in a Joule-Thomson orifice 114. The Joule-Thomson orifice 114 can be positioned near the distal working tip 104 to allow the cryogenic fluid exiting the Joule-Thomson orifice 114 to expand into an expansion chamber. In embodiments in which the cryoprobe 100 is configured as a cryoneedle, the distal working tip 104 can penetrate the patient's skin. In another embodiment, the cryoprobe 100 can be a flexible probe and can be inserted by a catheter.

[0048] Cryosurgical tools, such as cryoneedles, may have a variety of connections. For example, cryoneedles typically include a supply conduit for conveying the freezing medium toward a Joule-Thomson orifice in the tip, and a return conduit for discharging the freezing medium from the tip. The cryosurgical system may also include a feedback loop for recirculating the freezing medium discharged in the return conduit back into the supply conduit for conveying it back toward the tip. The cryosurgical tool may also include a heater 116 in the tip, which allows the cryosurgical tool to deliver freeze-thaw cycles by alternately cooling the tip to cryogenic temperatures and then heating it again. In some such examples, the lead wires, terminations, and heater 116 wires may be bonded or otherwise attached to the cryogenic fluid supply tube 112 and may be spaced from the inner surface 120 of the probe shaft 102 to electrically insulate the probe shaft 102 (which may be electrically conductive) from the energized heater 116. The proximal connector 108 can facilitate connection of the cryoprobe 100 to the connection interface 30, the control system 40, and / or the freezing medium source 60. Additionally, the proximal connector 108 can also have conductive components (e.g., portions of the proximal pins 111) to be in electrical communication with a corresponding probe shaft 102 (e.g., for use with a heater 116). These connections can terminate in a connector interface that allows connections to be made to a variety of sources.

[0049] The connector interface can provide one or more connections to supplies used by the cryosurgical tool. For example, the connection interface 200 can include one or more electrical connections for coupling to a cryoneedle (e.g., at the proximal connector 108). Additionally or alternatively, the connection interface 200 can be used to connect the cryosurgical tool to a cryomedia source, for example, via a coupler. Cryosurgical systems typically incorporate one or more couplers. In a typical application, the coupler includes a male connector and a female connector for connecting a pressurized cryomedia source to the cryosurgical tool to provide a liquid-tight seal therebetween. The male and female connectors used in cryosurgical systems are typically secured in place by threaded connectors. Threaded connectors have many disadvantages. For example, they cannot be quickly connected and disconnected, and the threads on the male and female parts can become crossed. Threaded connectors also require an additional tool, such as a wrench, to torque the connection to ensure that the connection is maintained under pressure. The principles of the present disclosure can prove advantageous in these typical applications, which are described in more detail below.

[0050] 3 is a cross-sectional front view of a portion of a connection interface 200 that allows for connection of the cryoprobe of FIG. 2. This connection interface 200 may be similar to the connection interfaces described elsewhere herein, including the connection interface 30 described above. As described therein, this connection interface 200 may be provided inside the magnet room (e.g., via a mobile cart, such as the mobile cart 50 of FIG. 1), or at another suitable connection location within the system. When the connection interface 200 is provided on the mobile cart 50, it is advantageously positionable within the magnet room (e.g., the magnet room 12 of FIG. 1). The connection interface 200 includes a housing portion in the form of a manifold 202 having a connection port 204 for connecting to the cryoprobe 100. The manifold 202 may include the connection port 204 in the form of a recessed feature formed in the manifold 202. As can be seen here, the manifold 202 includes a freezing medium supply line 209 and a freezing medium return line 211. In an advantageous embodiment, the manifold 202 may include a single common freezing media supply line 209 common to all connection ports 204. Alternatively, the manifold 202 may include two or more freezing media supply lines. Each connection port 204 may be fluidly connected to a freezing media supply line 209 such that freezing media from a freezing media source (e.g., freezing media source 60 in FIG. 1 ) is conveyed to the freezing media supply line 209 by first, second, third, and fourth sets of fluid connection lines (e.g., connection lines 62, 64, 66, 68 in FIG. 1 ). The freezing media supply line 209 may then supply freezing media to a freezing media supply pipe (e.g., freezing media supply pipe 112 in FIG. 2A ) of a freeze probe connected to a corresponding connection port 204 and returned to the freezing media source via a freezing media return line 211. Most notably, the connection interface 200 shown here differs from that discussed above as a coupler 220 according to the principles of the present disclosure is provided therewith. Further details regarding this coupler 220 are provided below.

[0051] 3A-3E illustrate various features of a coupler 220 in accordance with the principles of the present disclosure. In particular, FIG. 3A illustrates a diagram of the coupler 220. FIG. 3B illustrates a side view of the coupler 220 with a multi-part connector. FIG. 3C illustrates a side view of the coupler 220 with a valve 326 connected thereto. FIG. 3D illustrates a side view of the coupler 220 of FIG. 3A with a clamp 332 for securing the connector of the coupler 220. FIG. 3E illustrates a side view of the coupler 220 of FIG. 3C with a clamp 332 for securing the connector of the coupler 220. As discussed above, these couplers 220 can be used to advantageously couple a cryosurgical tool to a cryomedia source. For example, a cryosurgical system can include a cryosurgical tool having a cryomedia supply conduit and a cryomedia source having a cryomedia feed conduit. The cryomedia feed conduit can be connectable to the cryomedia supply conduit via the coupler 220. A coupler 220 according to the principles of the present disclosure can connect a cryosurgery tool to a cryogenic medium source via a mating connection made to a cryogenic medium supply line via one or more connectors that provide at least a liquid-tight seal for operation.

[0052] As generally shown in these figures, a coupler 220 according to the principles of the present disclosure can include a first sealing engagement and a second sealing engagement. The coupler 220 can be reusable since the sealing steps can be repeated while minimizing the risk of detrimental deformation or damage incurred by typical couplers, such as the threaded couplers described above. The coupler 220 can have a formable flow path that occurs, for example, when the connectors of the coupler 220 are secured together. The first sealing engagement can be configured to provide a first seal of the coupler 220 at a first temperature condition. The second sealing engagement can be configured to provide a second seal of the coupler 220 at a second temperature condition that is different from the first temperature condition. In an embodiment, a working medium (e.g., a cryogenic medium such as a cryogenic fluid or gas) can flow through the flow path. The first and second temperature conditions can be responsive to the flow of the working medium through the flow path. The cryosurgical system can include a heater configured to heat a portion of at least one of the first connector 310 and the second connector 320, and the coupler 220 is configured to be thawed by operation of the heater to release the first sealing engagement.

[0053] The mating connectors of the coupler 220 can facilitate the formation of a fluid flow path. For example, the coupler 220 can include a first connector 310 and a second connector 320. A formable fluid flow path can be formable through mating of the first connector 310 with the second connector 320. In one example, the first connector 310 can include a first fluid conduit and the second connector 320 can include a second fluid conduit. The cryosurgery system can include a clamp 332 for securing the first connector 310 and the second connector 320 in a fluid tight arrangement such that the first conduit 314 is in fluid communication with the second conduit 324, and a clamp locator (not shown) for positioning the clamp 332 such that the first connector 310 and the second connector 320 are aligned. While described herein as having first and second connectors 310, 320, it is noteworthy that the present disclosure should not be limited to an interpretation requiring only two connectors. Conversely, the present disclosure relates to a coupler 220 having multiple connectors.

[0054] A freezing medium can flow through a flow path formed by mating a first connector 310 with a second connector 320. The flow path can be configured to receive a cryogenic medium from a cryogenic medium supply conduit. The freezing medium can flow through the coupler 220 to a cryoneedle for use in a cryosurgery system. While flowing through the flow path, the freezing medium engages the first and second connectors 310, 320 and undergoes heat exchange (e.g., cooling if a freezing medium is used).

[0055] Depending on the characteristics of the first and second connectors 310, 320, the first and second connectors 310, 320 change over time as the freezing medium flows through the flow path. For example, the first connector 310 may have a first coefficient of thermal expansion and the second connector 320 may have a second coefficient of thermal expansion. The second coefficient of thermal expansion may be different from the first coefficient of thermal expansion. In this regard, the physical characteristics (e.g., shape, area, volume, and density) of the first and second connectors 310, 320 may change relative to one another. When properly adjusted according to the principles of the present disclosure, these changes may create a sealing engagement between the first connector 310 and the second connector 320. For example, as further described below, certain portions of the first and second connectors 310, 320 may be made to eliminate clearances between them when heat exchange occurs in the first and second connectors 310, 320.

[0056] The coefficients of thermal expansion can be selected such that the first and second connectors 310, 320 change at different rates during operation. In this regard, the sealing engagement between the first connector 310 and the second connector 320 can be facilitated via thermal contraction or thermal expansion of the first connector 310 and the second connector 320. The first and second coefficients of thermal expansion can be selected such that cooling causes first complementary surfaces of the first and second connectors 310, 320 to form a first sealing engagement. In an embodiment, the first and second connectors 310, 320 can have different genders such that one is a male connector and the other is a female connector. In this regard, the first connector 310 can be configured to receive the second connector 320 such that under a first temperature condition, an outer surface of the first connector 310 engages an inner surface of the second connector 320 to form a first sealing engagement. In an embodiment, a first sealing engagement is provided between a first complementary surface of the first connector 310 and a first complementary surface of the second connector 320. In an embodiment, a second sealing engagement may be provided between a second complementary surface of the first connector 310 and a second complementary surface of the second connector 320. In an embodiment, a resilient seal 330 may be provided between the second complementary surfaces. The second sealing engagement may be provided by a resilient seal 330 arranged between the second complementary surface of the first connector 310 and the second complementary surface of the second connector 320.

[0057] When so configured, the coupler 220 can function as a temperature dependent two-stage seal coupler 220. As previously described, the first and second seal engagements can correspond to first and second temperature conditions, respectively. These temperature conditions can be ranges of temperatures experienced during operation. Additionally or alternatively, the first temperature condition can include a first temperature range and the second temperature condition can include a second temperature range that is different from the first temperature range. Under these circumstances, the first seal engagement can occur at a different time than the second seal engagement as the coupler 220 experiences cooling during the cryosurgery operation, as described further below. In an embodiment, the first temperature range can be lower than the second temperature range. The first temperature condition can include a first temperature range that includes cryogenic temperatures, such that the first seal engagement is formed at cryogenic temperatures. The second seal engagement can occur at a non-cryogenic temperature and / or can abut or overlap with the first seal engagement, such that the coupler 220 is continuously sealed throughout operation. For example, the first sealing engagement may occur only during a first temperature condition (e.g., a first engagement stage) and the second sealing engagement may occur only during a second temperature condition (e.g., a second engagement stage). Further details regarding the components within coupler 220 are provided below.

[0058] 3A illustrates a side view of a coupler 220 according to the principles of the present disclosure. In the non-limiting example illustrated here, the coupler 220 includes first and second connectors 310, 320. A distal end 316 of the first connector 310 has a frustoconical portion 316a. The first connector 310 forms a sealing engagement with the second connector 320 to form at least a liquid-tight engagement and fluidly connect the first conduit 314 to the second conduit 324. The first connector 310 has a first connection element 312 having a first coefficient of thermal expansion, and the second connector 320 has a second connection element 322 having a second coefficient of thermal expansion. An elastic seal 330 is provided between the first connector 310 and the second connector 320 and configured to facilitate the formation of a sealing engagement therebetween.

[0059] More specifically, the coupler 220 shown here is suitable for connecting a pressurized freezing medium source to a cryosurgery tool. The coupler 220 includes a first connector 310 having a first coefficient of thermal expansion. The first connector 310 has an exterior surface and a first conduit 314 configured to allow the passage of a freezing medium. The coupler 220 includes a second connector 320 having a second coefficient of thermal expansion. The second coefficient of thermal expansion is different from the first coefficient of thermal expansion. The second connector 320 includes an interior surface that is complementary to and adapted to receive the exterior surface of the first connector 310. The second connector 320 includes a second conduit 324 configured to allow the passage of a freezing medium. An elastic seal 330 is configured to facilitate the formation of a sealed engagement between the first connector 310 and the second connector 320. Coupling the first connector 310 to the second connector 320 forms a sealing engagement that is at least liquid-tight and places the first conduit 314 in fluid communication with the second conduit 324. The first and second thermal expansion coefficients are selected to cause cooling of the coupler 220 to cause an outer surface of the first connector 310 to form a sealing engagement (e.g., a first sealing engagement) with an inner surface of the second connector 320.

[0060] 3B shows a side view of a coupler 220 including a frusto-conical portion 316a at the distal end 316 of the first connector 310. This coupler 220 may be similar to couplers 220 described elsewhere herein. It is noted that the first connector 310 is formed from two separate pieces: a distal end 310a and a body portion 310b (or barrel portion 310b). In this example, the distal end 310a is frusto-conical.

[0061] In accordance with the principles of the present disclosure, as with other couplers disclosed elsewhere herein, a multi-stage sealing engagement is provided between the first connector 310 and the second connector 320. For example, as shown here in FIG. 3, the second connector 320 has an inner surface that is complementary to and adapted to receive an outer surface of the first connector 310 in an engaged arrangement. When the coupler 220 is initially formed by placing the first connector 310 in an engaged arrangement with the second connector 320, a sealing engagement (e.g., a second sealing engagement) between the first connector 310 and the second connector 320 is provided by the elastomeric seal 330. Typically, the sealing engagement may be initially formed at room temperature (typically 18° C. to 24° C.). In an embodiment, the elastomeric seal 330 may provide a reliable sealing engagement that is at least liquid-tight through temperatures as low as −40° C. This may be a first stage of sealing engagement, and may continue until or overlap with another sealing engagement occurring in another stage.

[0062] The multi-stage sealing engagement may occur at different temperature ranges experienced during operation. As the coupler 220 cools (e.g., in use, when a freezing medium is forced through the coupler 220 under high pressure), the elastic seal 330 continues to form a sealing engagement between the first connector 310 and the second connector 320. However, because the first connector 310 and the second connector 320 have different thermal expansion coefficients, the connectors thermally contract at different rates. As described above, the thermal expansion coefficients of the first connector 310 and the second connector 320 are selected such that cooling the coupler 220 causes the first connector 310 to form a sealing engagement with the second connector 320. In an embodiment, this sealing engagement begins to form at a temperature at which the liquid-tight seal provided by the elastic seal 330 (e.g., the second sealing engagement) is still maintained. Because the connectors are selected to have different thermal expansion coefficients, upon cooling, one connector will contract more over time compared to the other connector. This relationship reduces the gap or clearance between the first connector 310 and the second connector 320 until they sealingly engage one another. This sealing engagement not only provides at least a liquid tight seal between the first connector 310 and the second connector 320, but also secures the two connectors together. In this regard, the sealing engagement can be reversed by warming the coupler 220 back up to room temperature. Thus, a wrench can be used to torque the coupler 220 down to the required tension, eliminating the need to disconnect again.

[0063] Temperature range may be a design consideration for coupler 220. For example, sealing engagement may be maintained (albeit over multiple stages) between first connector 310 and second connector 320 over a wide temperature range. At higher temperatures (e.g., room temperature), this sealing engagement may be achieved by elastic seal 330. At lower temperatures (e.g., during cooling), this sealing engagement may be achieved by first connector 310 and second connector 320 forming a fixed arrangement with one another as a result of heat shrinkage to form a liquid-tight seal. For example, elastic seal 330 may be formed from a material selected to be guaranteed to provide a liquid-tight seal at temperatures as low as -40°C. At the same time, relative heat shrinkage between first connector 310 and second connector 320 results in a liquid-tight seal being formed between the two connectors at temperatures below -10°C. In this example, there is an overlapping temperature range of -40°C to -10°C where a liquid-tight seal is provided by both mechanisms.

[0064] In accordance with the principles of the present disclosure, the coupler 220 can be designed with overlapping temperature ranges in which liquid-tight sealing engagement is provided by multiple mechanisms. When used in a cryosurgery system, the coupler 220 is initially at room temperature (typically 18°C-24°C). As freezing media is fed through the system (e.g., through the first and second conduits), the coupler 220 is cooled. Thus, the elastomeric seal 330 initially provides a liquid-tight seal (e.g., during the initial stages of cooling), and then liquid-tight seals are provided by both mechanisms in the overlapping temperature ranges. When the connection union cools to the extent that the material from which the elastomeric seal 330 is formed begins to deform (and thus can no longer reliably maintain a liquid-tight seal), sealing engagement is still maintained between the first connector 310 and the second connector 320 as a result of relative thermal contraction. Thus, a liquid-tight seal is always provided between the first connector 310 and the second connector 320 over a wide temperature range.

[0065] Next, features of the first connector 310 in a non-limiting example are described. The first connector 310 includes a first conduit 314 having a first coefficient of thermal expansion and connectable to either a cryosurgery tool or a source of freezing media. The first connector 310 is brought into a connection union with a second connector 320, fluidly connecting the first conduit 314 to a second conduit 324. In an embodiment, the first connector 310 is a male connector (and therefore the second connector 320 is a female connector). In this regard, the male connector and the female connector can form a liquid-tight seal. The male connector can include a coefficient of thermal expansion different from the coefficient of thermal expansion of the female connector. The male connector can include an outer surface for receiving an elastic seal 330, the outer surface being complementary to an inner surface of the female connector. The male connector can include a first conduit 314 connectable to either a cryosurgery tool or a source of freezing media. The coefficient of thermal expansion of the male connector may be selected to cause the outer surface of the male connector to form a fluid-tight seal with the inner surface of the female connector upon cooling.

[0066] The physical characteristics of the first connector 310 can facilitate a sealing engagement with the second connector 320 during operation. For example, the first connector 310 can be a male connector having a frusto-conical portion 316a at a distal end 316. In this regard, the proximal end can be connected to a cryosurgery tool or a source of freezing medium, and the distal end 316 is the opposite end. Cooling can cause the outer surface of the first connector 310 to form a fluid-tight seal against the inner surface of the second connector 320, at least along a portion of the frusto-conical portion 316a of the first connector 310. The frusto-conical portion 316a can be formed from a separate piece relative to the remainder of the first connector 310, such that the first connector 310 comprises the frusto-conical portion 316a and a separate body (barrel) portion. Alternatively, the frusto-conical portion 316a and the body (barrel) portion can be integrally formed as a single piece.

[0067] Portions of the first connector 310 can have different coefficients of thermal expansion. For example, the first connector 310 can include a first connection element 312 having a first coefficient of thermal expansion. In this regard, the first connection element 312 is the portion of the first connector 310 that interfaces with the second connector 320, and therefore only this portion of the first connector 310 need be formed from a material having a first coefficient of thermal expansion. Optionally, the remaining portion of the first connector 310 can also be formed from a material having a first coefficient of thermal expansion. In an example where the first connector 310 includes a frustoconical portion 316a, the first connection element 312 can include the frustoconical portion 316a (or a portion of the frustoconical portion 316a), and only this portion of the first connector 310 can be formed from a material having a first coefficient of thermal expansion. Thus, it is optional for the remaining portions of first connector 310 (eg, body portion 310b) to be formed from this same material having the first coefficient of thermal expansion.

[0068] Optionally, the first connector 310 may have a lower coefficient of thermal expansion than the second connector 320. In this example, the first connector 310 may comprise a material with a low coefficient of thermal expansion such that it undergoes a relatively small contraction during cooling, while the second connector 320 comprises a material that contracts more when cooled. Upon cooling, this reduces the size of the gap or clearance between the first connector 310 and the second connector 320 until the first and second connectors 310, 320 are sealingly engaged. This arrangement may provide at least a liquid-tight seal, and may optionally be arranged to provide an air-tight seal. In an embodiment, the first connector 310 comprises an alloy having about 55%-70% nickel and about 30%-45% iron, and optionally, the first connector 310 comprises Invar (FeNi36). Invar is a material with a minimal coefficient of thermal expansion such that it barely contracts or expands when cooled or warmed.

[0069] If the first connector 310 includes a frusto-conical portion 316a at its distal end 316, then only the frusto-conical portion 316a (or a portion thereof) of the first connector 310 may need to include an alloy having about 55%-70% nickel and about 30%-45% iron, preferably the alloy is Invar (FeNi36). In this embodiment, the remaining portions of the first connector 310 may be formed from any other materials suitable for use in a cryoablation system, such as non-corrosive metals and alloys.

[0070] Features of the second connector 320 are now described. In an embodiment, the second connector 320 can have a second coefficient of thermal expansion. The second connector 320 can include a second conduit 324 that can be connected to a cryosurgery tool or a source of freezing medium. The second connector 320 can be coupled to the first connector 310 to place the second conduit 324 in fluid communication with the first conduit 314. The second connector 320 can optionally have a second coefficient of thermal expansion different from the coefficient of thermal expansion of the first connector 310.

[0071] When the second connector 320 is a female connector, the first connector 310 may be a male connector. In this regard, a female connector is disclosed for mating to a male connector to form a fluid-tight seal. The female connector may include a coefficient of thermal expansion different from the coefficient of thermal expansion of the male connector. The female connector may include an inner surface complementary to an outer surface of the male connector. The female connector may include a (second) conduit configured for fluid communication with either a cryosurgery tool or a source of freezing medium. The coefficient of thermal expansion of the female connector may be selected to cause the outer surface of the male connector to form a fluid-tight seal with the inner surface of the female connector upon cooling.

[0072] Portions of the second connector 320 can have different coefficients of thermal expansion. The second connector 320 can optionally include a second connection element 322 having a second coefficient of thermal expansion. In an embodiment, the second connection element 322 is a portion of the second connector 320 that interfaces with the first connector 310. In this regard, only this portion of the second connector 320 may be formed of a material having a second coefficient of thermal expansion. Optionally, the remaining portion of the second connector 320 may also be formed of a material having a second coefficient of thermal expansion. In the case where the first connector 310 includes the frustoconical portion 316a, the second connection element 322 can include a portion of the second connector 320 that interfaces with the frustoconical portion 316a of the first connector 310. In this regard, only this portion of the second connector 320 may need to be formed of a material having a second coefficient of thermal expansion. Therefore, it is optional for the remaining portion of the second connector 320 to be formed from this same material having the second coefficient of thermal expansion.

[0073] Optionally, the second connector 320 can include a material having a higher coefficient of thermal expansion than the first connector 310. In this example, the second connector 320 can include a material selected to exhibit a greater rate of contraction during cooling than the material selected for the first connector 310. For example, the second connector 320 can include an alloy having iron and carbon and optionally steel. For example, the second connector 320 can include stainless steel 300 series, which is particularly suitable for use in a cryoablation environment because it is non-corrosive.

[0074] Next, the characteristics of the first and second conduits will be described. Starting with the first conduit 314, it may be connectable to either a cryosurgery tool or a cryomedia source. The first conduit 314 may be configured to allow the passage of a cryomedia. When the coupler 220 is used in a cryosurgery system, the first conduit 314 may be connected to either a cryosurgery tool or a cryomedia source. In this regard, if the first conduit 314 is connected to a cryosurgery tool, the second connector 320 may be connected to a cryomedia source, and vice versa. In an embodiment, the first conduit 314 may be integrally formed within the first connector 310. Alternatively, the first conduit 314 may be formed from a separate piece from the first connector 310 such that the first connector 310 has an internal channel such that the first connector 310 can move freely along the first conduit 314 coaxially with the first conduit 314.

[0075] Regarding the second conduit 324, in an embodiment, it can be connected to either a cryosurgery tool or a freezing medium source. In this regard, the second conduit 324 can be configured to allow the passage of a freezing medium. When the coupler 220 is used in a cryosurgery system, the second conduit 324 can be arranged to be connected to either a cryosurgery tool or a freezing medium source. If the first conduit 314 is connected to a cryosurgery tool, the second connector 320 can be connected to a freezing medium source, and vice versa. In one embodiment of the present invention, the second conduit 324 is integrally formed within the second connector 320. Alternatively, the second conduit 324 is formed from a separate piece from the second connector 320, and in this embodiment, the second connector 320 has an internal channel so that the second connector 320 can move freely along the second conduit 324 coaxially with the second conduit 324.

[0076] 3C illustrates a side view of a coupler 220 according to the principles of the present disclosure. As shown therein, the coupler 220 includes a frustoconical portion 316a at a distal end 316 of the first connector 310, and the second connector 320 includes a valve 326. The first connector 310 includes an extension 318 beyond the frustoconical portion 316a at the distal end 316 of the first connector 310 such that the first connector 310 is configured to open the valve 326 when the first connector 310 is connected in sealing engagement with the second connector 320. Opening the valve 326 places the first conduit 314 in fluid communication with the second conduit 324. The valve 326 shown here in FIG. 3 is a ball-and-socket valve 326 having a ball 326a and a socket 326b. In this regard, the valve 326 may open to allow the passage of fluid only when sealing engagement is made. Under these circumstances, when used in a cryosurgical system, the system does not need to be depressurized since coupler 220 can be connected and disconnected when the system is under pressure.

[0077] Next, the elastic seal 330 will be described. As described above, the elastic seal 330 is provided to form a sealing engagement between the first connector 310 and the second connector 320. The elastic seal 330 is formed from a material capable of providing a sealing engagement at temperatures well below about 0° C., optionally as low as about −40° C. The sealing engagement is maintained by the elastic seal 330 until the material becomes insufficiently elastic to provide the sealing engagement. In an embodiment, this phenomenon begins to occur when the coupler 220 is cooled to about −40° C. However, below these temperatures, the sealing engagement (e.g., the first sealing engagement) is already provided by the first connector 310 forming a liquid-tight seal against the inner surface of the second connector 320, since the two connectors include materials with different thermal contraction coefficients.

[0078] The temperature at which the first connector 310 and the second connector 320 form a seal with each other depends on the materials selected. In an embodiment, the materials are selected such that the seal is formed at a temperature of -10°C or lower. Thus, the materials of the resilient seal 330, the first connector 310, and the second connector 320 may be selected such that there is an overlapping temperature range where the sealing engagement of the coupler 220 is provided by both the resilient seal 330 and the relative contraction of the two connectors. This overlapping temperature range may be from about -10°C to about -40°C. In an embodiment, the resilient seal 330 is an elastomeric resilient seal 330, optionally formed from a fluoropolymer such as silicone. In an embodiment, the resilient seal 330 is an O-ring seal. In an embodiment, the resilient seal 330 is provided on the first connector 310 before the connecting union is formed. In this regard, after the first connector 310 is coupled to the second connector 320, the elastic seal 330 can contact both the first connector 310 and the second connector 320 (e.g., such that a second sealing engagement is formed).

[0079] Next, the heater features will be described. In an embodiment, as described above, a heater (not shown) is provided and configured to heat a portion of the first connector 310 and / or the second connector 320. In this regard, the heater can be used to release the sealing engagement between the first connector 310 and the second connector 320 (e.g., between the outer surface of the first connector 310 and the inner surface of the second connector 320). When the coupler 220 is used in a cryoablation system, the coupler is cooled to a cryoablation temperature of -160°C or less. At these temperatures, the sealing engagement between the first connector 310 and the second connector 320 is maintained as a result of the relative thermal contraction rates of at least the two connectors. Once the cryoablation procedure is completed, the connection union warms up to room temperature and eventually, the sealing engagement between the first connector 310 and the second connector 320 is released, albeit rather slowly. By incorporating a heater configured in this manner, a portion of the first connector 310 and / or the second connector 320 can be heated to accelerate the warming process, thereby allowing the coupler 220 to be quickly disconnected at the end of the cryoablation procedure.

[0080] 3D and 3E illustrate various features of a coupler according to the principles of the present disclosure. As described in more detail below, the clamp is useful with couplers 220 disclosed elsewhere herein. FIG. 3D illustrates a side cross-sectional view of a coupler 220 having a frusto-conical portion 316a at a distal end 316 of the first connector 310 with a clamp 332 for securing the first connector 310 and the second connector 320 in sealing engagement such that the first conduit 314 is in fluid communication with the second conduit 324. FIG. 3E illustrates a side cross-sectional view of a coupler 220 having a frusto-conical portion 316a at a distal end 316 of the first connector 310. The second connector 320 includes a valve 326, and the first connector 310 includes an extension 318 beyond the frusto-conical portion 316a at the distal end 316 of the first connector 310. So arranged, the extension 318 is configured to open the valve 326 upon coupling the first connector 310 to the second connector 320 to form a sealed engagement. Further shown is a clamp 332 for securing the first connector 310 and the second connector 320 together in sealed engagement such that the first conduit 314 is in fluid communication with the second conduit 324.

[0081] 3D has a first connector 310 including a frusto-conical portion 316a at its distal end 316, and further includes a clamp 332. The clamp 332 is configured to secure the first connector 310 and the second connector 320 together in a sealed engagement in which the first conduit 314 is in fluid communication with the second conduit 324. The coupler 220 shown here further includes a spring-loaded push-fit system 334 to ensure a tight connection between the first connector 310 and the second connector 320. Optionally, an actuation lever (not shown) is also incorporated to precisely position the clamp 332.

[0082] The coupler 220 shown in Figure 3E shows a first connector 310 including a frusto-conical portion 316a at its distal end 316 and a second connector 320 including a valve 326. The first connector 310 may include an extension 318 beyond the frusto-conical portion 316a. Similar to Figure 3D, Figure 3E shows a coupler 220 including a clamp 332 and a spring-loaded push-fit system 334. Although not shown here, there are examples of couplers 220 in which a clamp 332 is present without a spring-loaded push-fit system 334, as described below.

[0083] Although described above with respect to cooling applications, examples adapted for heating are also contemplated. In this regard, the coupler 220 and associated principles described above (and elsewhere herein) may also be applied to heating applications. For example, the first and second thermal expansion coefficients may be selected such that the first and second connectors 310, 320 advance into sealing engagement when the connectors are heated (e.g., by directing a heating medium through the first and second conduits).

[0084] Regardless of cooling or heating compatibility, the coupler 220 may benefit from a disposable cover (not shown) to mitigate damage from use. For example, repeated use of the first and second connectors 310, 320 may cause wear between their complementary surfaces. Thus, the disposable cover may be designed to cover these surfaces, such as the frustoconical portion 316a and / or the body portion 316b of the first and second connectors 310, 320. In one example, the disposable cover is designed to cover one or more complementary surfaces of the first connector 310, and in another example, the disposable cover is designed to cover one or more complementary surfaces of the second connector 320. Such a disposable cover may include a soft compliant metal having a yield point lower than the yield point of the first and / or second connectors 320. In this regard, the disposable cover may be deformable, thereby facilitating the formation of a seal between the first connector 310 and the second connector 320. For example, in cooling applications, the disposable cover may include copper or a similar metal, and in heating applications, the disposable cover may include gold or a similar metal, these are just a few examples among many others.

[0085] The features of the clamp 332 will now be described with respect to Figures 3D and 3E. Inserting the first connector 310 into the second connector 320 to form a sealing engagement can initially place the first conduit 314 in fluid communication with the second conduit 324. The elastic seal 330 can provide a sealing engagement between the first connector 310 and the second connector 320, but additional means may be required to securely hold the coupler 220 in place, especially when the coupler 220 is used in a cryosurgery system under pressure. Optionally, a push-fit system 334 is used when the first connector 310 and the second connector 320 form a sealing engagement together. Using the push-fit system 334 can ensure a sealing connection strong enough to withstand pressures above atmospheric pressure and can eliminate the need to screw one connector into the other. The push-fit system 334 can be a spring-loaded push-fit system 334 that provides an enhanced insertion force. Optionally, the push-fit system 334 is secured in place by a clamp 332 that allows the connection union to withstand higher pressures without being forcibly separated. For a particularly secure sealed engagement, the push-fit system 334 can be a spring loaded push-fit system 334 secured by a clamp 332. The inclusion of either the spring loaded push-fit system 334, the clamp 332, or both ensures that a consistent insertion force is applied after the first connector 310 is inserted into the second connector 320 and forms a sealed engagement.

[0086] More specifically, the clamp 332 may be configured to secure (e.g., couple) the first connector 310 and the second connector 320 in a sealing engagement. Under these circumstances, the first conduit 314 may be in fluid communication with the second conduit 324. Incorporating the clamp 332 into the coupler 220 may ensure that the first connector 310 and the second connector 320 are secured in a sealing engagement (e.g., when they are initially coupled together). When the coupler 220 is at room temperature, the elastic seal 330 may only provide a sealing engagement between the first connector 310 and the second connector 320. Thus, incorporating the clamp 332 ensures that the two connectors are secured to each other and have a sealing engagement therebetween. This arrangement may be particularly useful when the coupler 220 is used in a cryoablation system during the initial stages of cooling. At this point, the first connector 310 and the second connector 320 may have had insufficient thermal shrinkage for the two connectors to sealingly engage. In this regard, certain examples of coupler 220 may include clamp 332 instead of or in addition to a resilient member. If coupler 220 is formed with a spring-loaded push-fit system 334, clamp 332 may be fixed in place on coupler 220. Of course, in embodiments, clamp 332 may include multiple separate parts that together form clamp 332. In some embodiments, clamp 332 is another mechanical clamp, such as a screw clamp or a lever clamp.

[0087] Particularly useful may be a feature for positioning the clamp 332. Thus, the coupler 220 may include a locator (not shown) for precisely positioning the clamp 332 such that the first connector 310 and the second connector 320 are aligned to ensure that the first conduit 314 is in fluid communication with the second conduit 324. In particular, the locator for precisely positioning the clamp 332 is an actuating lever. For example, the actuating lever may be configured to insert the first connector 310 into the second connector 320 (or vice versa). The insertion may include applying a force (directly or indirectly) to one or both of the connectors 310, 320. In other examples, the lever may be more of a guide that guides one connector into engagement with the other connector. These examples are just a few of many examples of levers.

[0088] FIG. 4 illustrates a flow diagram of a method 400 for coupling surgical tools according to the principles of the present disclosure. Such a method may be useful for coupling a cryogenic fluid source to a cryosurgical tool using a coupler. As shown therein, the method 400 may include, at step 410, sealing the coupler with a first seal via a first seal engagement configured to provide a first seal of the coupler at a first temperature condition. Step 420 of the method 400 may include causing a temperature change in the coupler. Step 430 of the method 400 may include sealing the coupler with a second seal via a second seal engagement configured to provide a second seal of the coupler at a second temperature condition different from the first temperature condition. Step 440 of the method 400 may include inducing the coupler to a temperature at which the coupler may be decoupled. In an embodiment, the method 400 may include clamping the first and second connectors in a liquid-tight arrangement such that a first conduit of the first connector is in fluid communication with a second conduit of the second connector.

[0089] Sealing the coupler can be a multi-step process. In an embodiment, sealing the coupler with a first seal via a first seal engagement configured to provide a first seal of the coupler at a first temperature condition can include allowing first complementary surfaces of the first and second connectors to move into sealing engagement. The first connector can have a first coefficient of thermal expansion and the second connector can have a second coefficient of thermal expansion different from the first coefficient of thermal expansion. In an embodiment, sealing the coupler with a second seal via a second seal engagement configured to provide a second seal of the coupler at a second temperature condition different from the first temperature condition can include forming a fluid seal between second complementary surfaces of the first and second connectors.

[0090] Various modifications and additions can be made to the exemplary embodiments described without departing from the scope of the present invention. For example, while the above embodiments refer to certain features, the scope of the present invention also includes embodiments having different combinations of features and embodiments that do not include all of the described features. Accordingly, the scope of the present invention is intended to embrace all such alternatives, modifications, and variations that fall within the scope of the claims, together with all equivalents thereof.

Claims

1. A coupler having a formable flow path, a first sealing engagement configured to provide a first seal for the coupler at a first temperature condition; and a second seal engagement configured to provide a second seal of the coupler at a second temperature condition different from the first temperature condition.

2. 2. The coupler of claim 1, further comprising a first connector and a second connector, the formable flow path being formable by mating the first connector with the second connector to enable working medium to flow through the flow path.

3. 3. The coupler of claim 1 or 2, wherein at least one of the first and second sealing engagements is provided between a complementary surface of a first connector and a complementary surface of a second connector, the first connector having a first coefficient of thermal expansion and the second connector having a second coefficient of thermal expansion different from the first coefficient of thermal expansion.

4. 4. The coupler of claim 3, wherein the first sealing engagement is provided between a first complementary surface of the first connector and a first complementary surface of the second connector, the second sealing engagement is provided between a second complementary surface of the first connector and a second complementary surface of the second connector, and optionally a resilient seal is provided between the second complementary surfaces.

5. 5. The coupler of claim 1, wherein the first connector is configured to receive the second connector such that, under the first temperature condition, an outer surface of the first connector engages an inner surface of the second connector to form at least one of a first engagement portion and a sealing engagement.

6. the first temperature condition includes a first temperature range, and the second temperature condition includes a second temperature range different from the first temperature range; 6. The coupler of claim 1, wherein the first temperature range is lower than the second temperature range, the first temperature range has minimal overlap with the second temperature range, and the first temperature range includes cryogenic temperatures.

7. 1. A cryosurgical system comprising: a cryosurgical tool having a cryo-medium supply conduit; and a cryo-medium source having a cryo-medium feed conduit connectable to the cryo-medium supply conduit via a coupler, the coupler comprising: a first sealing engagement configured to provide a first seal for the coupler at a first temperature condition; a second seal engagement configured to provide a second seal of the coupler at a second temperature condition different from the first temperature condition.

8. 8. The cryosurgery system of claim 7, wherein the coupler further comprises a first connector and a second connector, a flow path of the coupler formable via engagement of the first connector and the second connector, the flow path configured to receive cryogenic medium from the cryogenic medium supply conduit.

9. 9. The cryosurgical system of claim 7 or 8, wherein the first temperature condition comprises a first temperature range that includes a cryogenic temperature such that the first sealing engagement is formed at the cryogenic temperature, the cryosurgical system further comprising a heater configured to heat a portion of at least one of the first connector and the second connector, the coupler being configured to be thawed by operation of the heater to release the first sealing engagement.

10. 10. The cryosurgery system of claim 7, wherein a first connector has a first coefficient of thermal expansion and a second connector has a second coefficient of thermal expansion different from the first coefficient of thermal expansion, the first coefficient of thermal expansion and the second coefficient of thermal expansion selected to cause first complementary surfaces of the first and second connectors to form the first sealing engagement upon cooling, and the second sealing engagement is provided by a resilient seal arranged between second complementary surfaces of the first and second connectors.

11. 9. The cryosurgical system of claim 8, wherein the first connector comprises a first fluid conduit and the second connector comprises a second fluid conduit, the cryosurgical system further comprising a clamp for securing the first and second connectors in a fluid-tight arrangement such that the first conduit is in fluid communication with the second conduit, and a clamp locator for positioning the clamp so that the first and second connectors are aligned.

12. 1. A method of coupling a cryogenic fluid source to a cryosurgery tool using a coupler, comprising: sealing the coupler with a first seal via a first seal engagement configured to provide a first seal of the coupler at a first temperature condition; and sealing the coupler with the second seal via a second seal engagement configured to provide a second seal of the coupler at a second temperature condition different from the first temperature condition.

13. 13. The method of claim 12, wherein sealing the coupler with the first seal via the first sealing engagement configured to provide the first seal of the coupler at the first temperature condition comprises allowing first complementary surfaces of first and second connectors to move into sealing engagement, the first connector having a first coefficient of thermal expansion and the second connector having a second coefficient of thermal expansion different than the first coefficient of thermal expansion.

14. 14. The method of claim 13, wherein sealing the coupler with the second seal via the second seal engagement configured to provide the second seal of the coupler at the second temperature condition different from the first temperature condition comprises forming a fluid seal between second complementary surfaces of the first and second connectors.

15. 15. The method of any one of claims 12 to 14, further comprising clamping the first and second connectors in a fluid-tight arrangement such that a first conduit of the first connector is in fluid communication with a second conduit of the second connector.

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