Frozen probe with flexible handle

Abstract

Embodiments of the present disclosure relate to a cryoprobe, a cryoablation system, and a method of using a cryoprobe. A cryoprobe includes a needle and a handle configured to fluidly couple the needle to a refrigerant line. The handle is configured to bend to change a position of the needle relative to the refrigerant line.

Description

Technical Field

[0001] This disclosure relates to cryoablation probes including flexible handles and / or adjustable handles. Background Technology

[0002] This section provides background information in connection with this disclosure, which is not necessarily prior art.

[0003] Systems and methods for delivering cryoablation therapy may include a cryoablation probe introduced at or near a target tissue within a patient's body. The cryoablation system may include an extremely cold refrigerant (liquid, gas, or a mixture) that can be delivered through the probe, which is in thermal contact with the target tissue. Heat from the tissue is transported away from the tissue, through the probe, and into the refrigerant, thereby removing heat from the target tissue. This removal of heat causes the tissue to freeze, thus destroying the target tissue. It is desirable that the refrigerant have a sufficiently low temperature to freeze the target tissue rapidly and effectively.

[0004] Traditional or existing cryoprobes and related structures typically include a rigid configuration that does not allow bending and / or adjustment at the handle portion of the cryoprobe. This rigid configuration limits the ability to position the cryoprobe or may cause it to shift after it has been initially positioned at the desired treatment location. Therefore, there is a need for a cryoprobe that can have an adjustable configuration, such as the ability to bend at or near the handle. Improvements to existing cryoprobes are also needed to prevent or limit shift during cryoablation treatment. Summary of the Invention

[0005] This section provides a general overview of the invention and is not a complete disclosure of its full scope or all its features.

[0006] In various embodiments of this disclosure, a cryoablation probe is provided. The cryoablation probe may include a needle and a handle, the handle being configured to fluidly couple the needle to a refrigerant supply line. The handle may be configured to bend to change the position of the needle relative to the refrigerant supply line.

[0007] In one aspect, the handle can be configured to bend from a first position to a second position, in which the longitudinal axis of the needle is aligned with the longitudinal axis of the refrigerant supply line, and in the second position, the longitudinal axis of the needle is positioned at an angle relative to the longitudinal axis of the refrigerant supply line.

[0008] On the other hand, the angle of the second position of the cryoprobe can be in the range of 180 degrees and 90 degrees.

[0009] On the other hand, the handle may include a deformable member configured to maintain the needle in multiple positions relative to the refrigerant supply line.

[0010] On the other hand, the handle may include: a flexible outer member defining an inner cavity, and a deformable inner member positioned within the inner cavity, the deformable inner member being configured to maintain the position of the needle relative to the refrigerant supply line.

[0011] On the other hand, the flexible outer component and the deformable inner component can each have a cylindrical shape.

[0012] On the other hand, the handle may include a refrigerant supply pipe located within the cavity and radially inside the deformable internal component.

[0013] On the other hand, the deformable internal component and the refrigerant supply pipe can define a refrigerant flow path in which the refrigerant flows through the refrigerant supply pipe toward the tip of the needle and flows away from the tip of the needle in the space between the outer surface of the refrigerant supply pipe and the inner surface of the deformable internal component.

[0014] On the other hand, the handle may include a restraining member positioned within the cavity, radially outward of the deformable inner member. This restraining member may be configured to limit the bending of the handle.

[0015] On the other hand, the handle may include a refrigerant supply line and an external flexible member. The external flexible member may include at least one embedded wire configured to maintain the position of the needle relative to the refrigerant supply line.

[0016] On the other hand, at least one embedded wire may include a plurality of embedded wires.

[0017] On the other hand, each of the multiple embedded wires can be equidistantly spaced around the circumference of the outer flexible member.

[0018] In some embodiments, the handle of the freezing probe may include a flexible outer member and a deformable member configured to maintain the position of the probe relative to the refrigerant supply line.

[0019] On the other hand, the flexible outer member may include at least one longitudinal reinforcement configured to restrict bending of the flexible outer member in at least one plane.

[0020] On the other hand, at least one longitudinal reinforcement may include a first reinforcement and a second reinforcement positioned on opposite sides of the flexible outer member. The first reinforcement and the second reinforcement may include enlarged portions of the wall of the flexible outer member.

[0021] On the other hand, the handle can be configured to bend in multiple planes relative to the axis of the refrigerant supply line.

[0022] On the other hand, the handle can be configured to bend in at least two orthogonal planes relative to the axis of the refrigerant supply line.

[0023] On the other hand, the handle may include a deformable member configured to permanently deform to maintain the position of the needle relative to the refrigerant supply line.

[0024] In some embodiments, a cryoablation system is provided. The cryoablation system may include a cryoprobe of this disclosure and a cryoablation delivery device configured to deliver refrigerant to the cryoprobe.

[0025] In some embodiments, a method of using a cryoprobe is provided. The method of using a cryoprobe may include: positioning the cryoprobe of the present disclosure at a target tissue; bending the handle of the cryoprobe from a first position to a second position to orient the refrigerant supply line relative to the needle at a desired location; and initiating refrigerant flow to the cryoprobe while the handle is in the second position.

[0026] Other application areas will become clearer from the description provided herein. The descriptions and specific examples in this invention are for illustrative purposes only and are not intended to limit the scope of this disclosure. Attached Figure Description

[0027] The accompanying drawings described herein are for illustrative purposes only, and not for all possible implementations, and are not intended to limit the scope of this disclosure.

[0028] Figure 1 This is a schematic diagram of an exemplary cryoablation apparatus according to some embodiments of the present disclosure.

[0029] Figure 2 This is a side cross-sectional view of an exemplary cryoprobe according to some embodiments of the present disclosure.

[0030] Figure 3 This is a cross-sectional view of an exemplary flexible handle according to some embodiments of the present disclosure.

[0031] Figure 4 This is a cross-sectional view of another exemplary flexible handle according to some embodiments of the present disclosure.

[0032] Figure 5 This is a cross-sectional view of another exemplary flexible handle according to some embodiments of the present disclosure.

[0033] Figure 6 This is a cross-sectional view of another exemplary flexible handle according to some embodiments of the present disclosure.

[0034] The corresponding reference numerals indicate the corresponding parts in multiple views throughout the accompanying drawing. Detailed Implementation

[0035] Exemplary embodiments will now be described more fully with reference to the accompanying drawings.

[0036] Exemplary embodiments are provided to make this disclosure thorough and complete, and to fully convey the scope to those skilled in the art. Numerous specific details, such as examples of particular components, apparatuses, and methods, are set forth to provide a thorough understanding of embodiments of this disclosure. It will be apparent to those skilled in the art that these specific details are not required, that exemplary embodiments may be embodied in many different forms, and should not be construed as limiting the scope of this disclosure. In some exemplary embodiments, well-known processes, well-known apparatus structures, and well-known techniques are not described in detail.

[0037] The terminology used herein is for the purpose of describing specific exemplary embodiments only and is not intended to be limiting. As used herein, unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “the” are intended to also include the plural forms. The terms “comprising,” “including,” “containing,” and “having” are open-ended expressions and therefore indicate the presence of the stated features, elements, steps, operations, components, and / or parts, but do not exclude the presence or addition of one or more other features, elements, steps, operations, components, and / or combinations thereof. Unless specifically indicated as an order of execution, the method steps, processes, and operations described herein should not be construed as having to be performed in the particular order discussed or shown. It should also be understood that additional or alternative steps may be employed.

[0038] When an element or layer is referred to as “on,” “joined to,” “connected to,” or “coupled to” another element or layer, it may be directly on, joined to, connected to, or coupled to that other element or layer, or there may be intermediate elements or layers. Conversely, when an element is referred to as “directly on,” “directly joined to,” “directly connected to,” or “directly coupled to” another element or layer, there are no intermediate elements or layers. Other terms used to describe relationships between elements should be interpreted in a similar manner (e.g., “between” vs. “directly between,” “adjacent” vs. “directly adjacent,” etc.). As used herein, the term “and / or” includes any and all combinations of one or more of the associated listed items.

[0039] While the terms first, second, third, etc., may be used herein to describe various elements, components, regions, layers, and / or portions, these elements, components, regions, layers, and / or portions should not be limited by these terms. These terms are used only to distinguish one element, component, region, layer, or segment from another region, layer, or segment. Unless the context clearly indicates otherwise, terms such as "first," "second," and other numerical terms used herein do not imply order or sequence. Therefore, without departing from the teachings of exemplary embodiments, the first element, first component, first region, first layer, or first segment discussed below may be referred to as a second element, second component, second region, second layer, or second segment.

[0040] Spatial terms such as "inside," "outside," "below," "below," "lower," "above," and "above" are used herein for descriptive purposes to describe the relationship of one element or feature to another element(s) or feature(s), as illustrated in the figures. Spatial terms are intended to cover different orientations of the device in use or operation, in addition to those depicted in the figures. For example, if the device in the figure is flipped, an element described as "below" or "below" of other elements or features would be oriented "above" of those other elements or features. Thus, the exemplary term "below" can encompass both above and below orientations. The device may be oriented in other ways (rotated 90 degrees or otherwise), and the spatial relative descriptors used herein should be interpreted accordingly.

[0041] In some embodiments of this disclosure, a cryoprobe including a flexible handle is provided. The cryoprobe may include a handle that couples the needle of the cryoprobe to a refrigerant line. The refrigerant line may include one or more tubes, lumens, or other conduits through which refrigerant (e.g., argon, nitrogen, etc.) flows to or out of the needle during operation of the cryoprobe. The refrigerant line may also include other elements, such as wires for sending or receiving signals for control or measurement of various aspects of the cryoprobe.

[0042] Conventional cryogenic probe handles are typically rigid, as they fix the relationship between the refrigerant line and the cryogenic probe needle. It should be understood that the refrigerant line can be a flexible tube capable of changing shape. In this disclosure, when discussing the relative relationship between the cryogenic probe needle and the refrigerant line, this relationship is defined as the relationship between the longitudinal axis of the needle and the longitudinal axis of the refrigerant line assuming it extends linearly from its connection with the cryogenic probe handle. Reference Figure 2The relationship between the refrigerant line 110 and the needle 114 is discussed as the relationship between the needle axis 212 and the refrigerant supply line axis 214. The refrigerant supply line axis 214 is defined at the point where the refrigerant line 110 connects to the handle 120. It can be understood that the refrigerant line 110 is connected to the refrigeration unit (such as...) Figure 1 (As shown) may bend during the process, but for the purposes of this disclosure, axis 214 is defined at the connection between refrigerant line 110 and handle 120.

[0043] In various examples of existing cryoprobes, the handle of the cryoprobe can orient the needle in a linear relationship. In other examples, the handle of existing cryoprobes can fix the relationship between the needle and the refrigerant tubing. For example, in a right-angled handle configuration, this angle might be 90 degrees. Flexibility and / or the ability to change the relationship between the needle and the refrigerant tubing can be desired. For example, after the needle of the cryoablation probe is positioned at the target tissue within the patient's body, the patient can move within the treatment room for imaging or other procedures. During imaging, the patient can be inserted into an imaging device where the space around the patient is limited. Changing, bending, or adjusting the orientation of the refrigerant tubing relative to the needle can be desired to allow space around the patient for imaging or other auxiliary procedures.

[0044] Furthermore, during treatment, multiple cryoprobes may be inserted into the patient. These multiple probes are typically inserted very close to each other. In these cases, the refrigerant lines of the multiple probes may interfere with each other. It is desirable to be able to move the refrigerant supply lines to locations further apart from each other to minimize or reduce mutual interference.

[0045] The aforementioned functionality is also desirable so that the cryoprobe needle, once positioned at or near the desired location in the target tissue, remains in place. If the refrigerant supply lines come into contact with each other or otherwise interfere with each other, the cryoprobe needle may move, affecting the treatment outcome. Furthermore, it is desirable to orient the refrigerant lines in a certain way to minimize needle movement.

[0046] The cryoprobe disclosed herein includes a flexible handle that allows a user to move and / or position the refrigerant tubing relative to the needle of the cryoprobe to a desired orientation. The user of the cryoprobe can manipulate the flexible handle to position the refrigerant tubing to minimize or reduce interference with other instruments or equipment that may be used in the treatment room. Once the user bends or moves the handle of the cryoprobe, the handle deforms in a manner to maintain the desired position. This helps to hold the needle of the cryoprobe in its desired position relative to the target tissue, thereby improving therapeutic efficacy.

[0047] Now for reference Figure 1An exemplary cryoablation device 100 is shown. The cryoablation device 100 may include a cryoablation console 102 and a cryoprobe 112. The cryoablation console 102 may include a cryocontroller 104, a refrigerant delivery device 106, and a refrigerant source 108. Although in Figure 1 The refrigerant source 108 is displayed inside console 102, but it may be located outside console 102. Refrigeration controller 104 may include a computing device or other controller capable of controlling the delivery of refrigerant (e.g., argon, helium, nitrogen, etc.) from refrigerant source 108 to cryogenic probe 112 using refrigerant delivery device 106. Refrigerant source 108 may be a suitable Dewar flask or other container capable of being filled with refrigerant. Refrigerant delivery device 106 may include a pump, one or more valves, and other suitable fluid delivery devices to fluidly connect the refrigerant source to refrigerant line 110 of cryogenic probe 112. Upon initiation of the refrigeration cycle, refrigeration controller 104 may cause refrigerant to move through a refrigerant flow path that includes a refrigerant supply line from refrigerant source through refrigerant line 110 to cryogenic probe 112. The refrigerant may then flow back to the refrigerant source via a refrigerant return line from cryogenic probe 112 back to refrigerant source 108, or it may be vented into ambient air.

[0048] The refrigerant line 110 may be a flexible tube or other conduit that may include multiple lumens to allow refrigerant to flow toward needle 114 in the supply direction and, respectively, away from needle 114 in the return direction. The refrigerant line 110 should be of sufficient length to allow the console 102 to be placed near the patient in the treatment room and to allow the patient to be moved into and out of the imaging equipment. In some examples, the refrigerant line length may be approximately 12 feet. In other examples, the refrigerant line 110 may have other lengths. In other examples, the refrigerant line 110 may be greater than approximately 12 feet. In other examples, the refrigerant line 110 may be less than approximately 12 feet.

[0049] The refrigerant line 110 fluidly couples the refrigerant source 108 to the cryoprobe 112. The cryoprobe 112 may include a needle 114. The needle 114 may be a pointed cylindrical tool or other elongated member configured to be inserted into patient tissue during treatment and positioned at or near a target tissue. The needle 114 may be configured to have a pointed tool with an outer diameter ranging from approximately 1 mm to approximately 4 mm. The cryoprobe 112 may also include a handle 116. The handle 116 may be bent or moved to allow the orientation of the needle 114 and the refrigerant line 110 to be changed or adjusted as needed.

[0050] In some examples, the handle 116 may include a vacuum cavity on or near the outer surface of the handle 116. The vacuum cavity isolates the outside of the handle from a refrigerant at an extremely low operating temperature, through which the refrigerant flows to the cryoprobe 112. This allows an operator to touch or otherwise manipulate the cryoprobe 112 during treatment.

[0051] Although not shown, more than one cryoprobe 112 may be connected to the console 102. Multiple cryoprobes 112 may be used in combination during a single cryoablation treatment. The console 102 may be configured to deliver refrigerant to each of the multiple cryoprobes 112. These cryoprobes 112 may be similar to each other or different to produce ice balls of different sizes and shapes, thereby freezing and destroying the target tissue.

[0052] Now for reference Figure 2 An exemplary cryoprobe 112 is shown. This cryoprobe 112 can be used in conjunction with a cryoablation device, such as the previously described cryoablation device 100. In this example, the cryoprobe 112 may include a needle 114 and a handle 120. The cryoprobe 112 can be coupled to a refrigerant source using a refrigerant line 110. The needle 114 can be any suitable cryoablation needle and can extend axially from the handle 120 along axis 212. The needle 114 can be made of a suitable metal or alloy, such as stainless steel. In other examples, other suitable materials such as ceramic can be used. The needle 114 can have various sizes or diameters suitable for creating the desired freezing zone or ice ball to freeze target tissue. In various examples, the needle 114 can have an outer diameter ranging from about 1 mm to about 4 mm. In other examples, other suitable sizes can be used.

[0053] The needle 114 may include a housing and an inner tube 204 extending radially along its length. The housing and the inner tube 204 may be positioned coaxially with each other. The inner tube 204 may include an opening at one end facing the tip 202 of the needle. During a refrigeration cycle, refrigerant (under high pressure) can flow through the inner tube 204 to the tip 202, and then the refrigerant can exit the inner tube 204 and expand in the Joule-Thomson chamber at or near the tip 202. This expansion causes the refrigerant temperature to drop. The refrigerant can then flow away from the tip 202 through a return channel defined between the inner surface of the housing and the outer surface of the inner tube 204.

[0054] The needle 114 can be coupled to the handle 120. The handle 120 can be made of plastic, composite material, or other suitable flexible material. The handle 120 can be fluidly and mechanically coupled to the needle 114. The inner cavity 204 and the outer shell of the needle 114 can be fluidly coupled to the supply cavity 210 and a return channel located radially outside the supply cavity 210, respectively. In this way, refrigerant can be supplied to the needle 114 through the handle 120, and refrigerant can flow from the needle 114 to the refrigerant line 110.

[0055] The flexible handle 120 may include an outer member 206, a deformable member 208, and a refrigerant supply pipe 210. The outer member 206 may form the outer surface of the handle and may be made of a flexible plastic tube. The outer member may have a wall thickness and a hollow interior forming an inner cavity. The deformable member 208 may be positioned inside the inner cavity of the outer member 206. The deformable member 208 may be a stretchable member that can be bent or shaped into a desired form and can maintain its deformed shape without external force. The deformable member 208 may undergo plastic deformation and retain its deformed shape. In some examples, the deformable member 208 may be made of annealed brass or stainless steel tubing to allow the deformable member to be shaped into a desired form without kinking or breaking.

[0056] The refrigerant supply pipe 210 can be positioned radially inside the deformable member 208. The refrigerant supply pipe 210 can also be made of a deformable material, but its outer diameter is smaller than that of the deformable member 208.

[0057] The handle 120 is flexible in that it can be shaped to position the needle 114 in various desired relative orientations with respect to the refrigerant line 110. The relative orientation of the needle 114 with respect to the refrigerant line 110 can be characterized by the relative position of the needle axis 212 with respect to the refrigerant line axis 214. As described above, the refrigerant line axis 214 is defined at the connection plane between the refrigerant line 110 and the handle 120. In various examples, the handle 120 is made of a suitable material and wall thickness to allow the handle 120 to move from a first position to a second position to change the angle of the needle 114 (or needle axis 212) with respect to the refrigerant line 110 (or refrigerant line axis 214). In some examples, the handle 120 may allow the angle of the needle 114 with respect to the refrigerant line 110 to be in the range of approximately 180 degrees to approximately 90 degrees. In some examples, the handle 120 may allow the angle of the needle 114 with respect to the refrigerant line 110 to be in the range of approximately 180 degrees to approximately 45 degrees. Although Figure 2 The flexible handle 120 is shown in a single plane, but the flexible handle 120 can move, bend, or fold in multiple planes, such as... Figure 2 The normal plane of the view shown, as well as various planes between orthogonal planes.

[0058] Now for reference Figure 3 An exemplary cross-section of the flexible handle 300 is shown. The flexible handle 300 may be similar to the handle 120 previously described, except that it couples the needle 114 to the refrigerant line 110 and allows relative movement between the needle 114 and the refrigerant line 110. The flexible handle 300 may allow movement and positioning of the needle 114 relative to the refrigerant line 110 as described above.

[0059] In this example, the handle 300 includes an outer member 302, a deformable member 304, and a refrigerant supply pipe 306. The outer member 302, the deformable member 304, and the refrigerant supply pipe 306 can be made of... Figure 2 The example shown is made of the previously described material and has a relative positioning. The outer member 302, the deformable member 304, and the refrigerant supply pipe 306 can be coaxially positioned about the central axis 308 of the handle 300. The deformable member 304 can be positioned radially inside and spaced apart from the outer member 302. This positioning can define an annular space 310 between the inner surface of the outer member 302 and the outer surface of the deformable member 304. Similarly, the refrigerant pipe 306 can be positioned radially inside and spaced apart from the deformable member 304 to define an annular space 312. The interior of the refrigerant pipe 306 can define a refrigerant cavity 308.

[0060] During the use of the cryogenic probe, refrigerant can flow to the needle tip through the cavity 308 of the refrigerant tube 306. The refrigerant can also flow away from the needle through the annular space 312 between the outer surface of the refrigerant tube 306 and the inner surface of the deformable member 304. The annular space 310 can be an air gap between the outer member 302 and the deformable member 304.

[0061] Now for reference Figure 4 An exemplary cross-section of another flexible handle 400 is shown. The flexible handle 400 may be similar to the previously described handle 120 in that it couples the needle 114 to the refrigerant line 110 and allows relative movement between the needle 114 and the refrigerant line 110. As previously described, the flexible handle 400 may allow movement and positioning of the needle 114 relative to the refrigerant line 110.

[0062] In this example, the handle 400 includes an outer member 402, a deformable member 404, and a refrigerant supply pipe 406. In this example, the deformable member 404 may be a stretchable conductor located in the wall of the outer member 402 and centered about a central axis 408. In this example, the handle 400 includes three deformable members 404, equally spaced around the circumference of the outer member 402. The deformable members 404 may have a suitable thickness to maintain the shape of the outer member when the handle 400 is shaped or bent into a desired configuration. While three deformable members 404 are shown in this example, other numbers of deformable members 404 may also be used. In some examples, the handle 400 may include more than three deformable members 404. In other examples, the handle 400 may include fewer than three deformable members 404, or may include only one deformable member 404.

[0063] In this example, each deformable member 404 has the same cross-sectional diameter. In other examples, deformable members 404 may have different cross-sectional shapes, sizes, or diameters. In some examples, deformable members 404 may be positioned and / or sized to restrict bending or flexing in a particular direction. For example, a deformable member 404 having a diameter larger than another deformable member 404 may be positioned on one side of the handle 400 where bending in a particular direction is desired. Other variations may be used in other examples.

[0064] Now for reference Figure 5 An exemplary cross-section of the flexible handle 500 is shown. The flexible handle 500 may be similar to the handles 120 and / or 300 previously described, in that it couples the needle 114 to the refrigerant line 110 and allows relative movement between the needle 114 and the refrigerant line 110. As previously described, the flexible handle 500 may allow movement and positioning of the needle 114 relative to the refrigerant line 110.

[0065] In this example, the handle 500 includes an outer member 502, a deformable member 504, and a refrigerant supply pipe 506. The outer member 502, deformable member 504, and refrigerant supply pipe 506 may be similar to corresponding elements of the handle 300. In this example, the handle 500 includes a restraining member 516 positioned in an annular space 510. The restraining member 516 is positioned radially inward of the outer member 502 and radially outward of the deformable member 504.

[0066] The limiting member 516 can be configured to limit or constrain the amount of bending that can be performed using the handle 500. The limiting member 516 can be configured to reduce the likelihood of kinking and / or breakage of one or more components of the handle 500 during use. In some examples, the limiting member 516 can limit the angle at which the handle can bend. In some examples, the limiting member 516 can limit the bending angle of the handle 500 to approximately 90 degrees. In other examples, the limiting member 516 can limit the bending of the handle 500 to other amounts or ranges.

[0067] In this example, the limiting member 516 may have a helical configuration. In other examples, the limiting member 516 may have a helical spring configuration. In other examples, a corrugated or undulating outer surface may be used. In the example shown, the limiting member is a separate member and is positioned in the space between the concentric members of the handle 500. In other examples, the limiting member 516 may be integrally formed and / or embedded therein with one of the outer member 502 and / or deformable member 504.

[0068] Now for reference Figure 6 An exemplary cross-section of another flexible handle 600 is shown. The flexible handle 600 may be similar to the previously described handles 120 and / or 300, in that it couples the needle 114 to the refrigerant line 110 and allows relative movement between the needle 114 and the refrigerant line 110. As previously described, the flexible handle 600 may allow movement and positioning of the needle 114 relative to the refrigerant line 110.

[0069] In this example, the handle 600 includes an outer member 602, a deformable member 604, and a refrigerant supply tube 606. The outer member 602, deformable member 604, and refrigerant tube 606 may be similar to corresponding elements of the handle 300. The outer member 602, deformable member 604, and refrigerant tube 606 may be coaxially positioned about a central axis 608, forming annular spaces 610 and 612. The cavity 614 of the refrigerant tube 606 can supply refrigerant to the needle of the cryoprobe.

[0070] In this example, the outer member 602 may include a configuration with a reinforcement 616. In this example, the reinforcement 616 is a protrusion extending outward from the outer surface of the outer member 602. The reinforcement 616 may be formed longitudinally in the outer member 602 and extend along the length of the outer member 602. The reinforcement 616 may be integrally formed with the wall of the outer member 602. In other examples, the reinforcement may be a separate component attached to the outer member, or it may be extruded or extruded therein along with the material of the outer member 602.

[0071] The reinforcement 616 can increase the strength of the outer member in a specific direction or plane relative to the central axis 608. The reinforcement 616 can limit or constrain the bending or movement of the outer member 602 and thus the handle 600 in a specific plane or direction. In this example, the outer member 602 includes two reinforcements 616, one of which is positioned on each side of the outer member 602 opposite to each other. In other examples, other numbers, orientations, or arrangements of reinforcements 616 may be used. In this example, the reinforcement 616 has a rectangular outline, but other shapes, such as triangles, circles, etc., may also be used.

[0072] The flexible handle disclosed herein can be used to perform more effective ablation treatments. The flexible handle allows the cryoprobe tubing to be positioned at the desired location, minimizing interference with other treatment devices and equipment, as well as other cryoprobes. The flexible handle can also minimize and / or reduce the likelihood of the cryoprobe needle shifting or displaced after it has been positioned relative to the target tissue at the desired location.

[0073] Consider various methods of using the flexible handle and cryoprobe of this disclosure. In one example method, the method may include positioning the needle of the cryoprobe at a desired location relative to target tissue within a patient. When positioning the needle at or near the target tissue, the handle of the cryoprobe may be configured in the desired orientation.

[0074] After positioning the cryoprobe needle, the handle of the cryoprobe can be bent or flexed to the desired location. This bending can be used to move the cryoprobe's refrigerant tubing away from another medical device. This bending reduces the height of the cryoprobe, preventing it from extending too far above the patient, allowing for easy insertion and removal of the imaging device. Furthermore, this bending reduces the height, thereby decreasing the lever arm of the cryoprobe and keeping the needle in the desired position during treatment. Additionally, this bending can position the cryoprobe and / or refrigerant tubing in the desired location to increase the likelihood of effective treatment.

[0075] The flow of refrigerant to the cryoprobe can then be initiated when the probe is in its new curved position. Cryoablation treatment can then be performed in this configuration. This flexibility is unavailable in existing cryoprobes and represents a significant improvement over currently available rigid, non-flexible cryoprobes.

[0076] The following is a list of non-limiting illustrative embodiments:

[0077] Illustrative Example 1: A cryogenic probe includes: a needle; and a handle configured to fluidly couple the needle to a refrigerant line, the handle being configured to bend to change the position of the needle relative to the refrigerant line.

[0078] Illustrative Example 2. A freezing probe according to Illustrative Example 1, wherein the handle is configured to bend from a first position to a second position, in the first position, the longitudinal axis of the needle is aligned with the longitudinal axis of the refrigerant supply line; in the second position, the longitudinal axis of the needle is positioned at an angle relative to the longitudinal axis of the refrigerant supply line.

[0079] Illustrative Example 3. A cryoprobe according to Illustrative Example 2, wherein the angle of the cryoprobe at the second position is in the range of 180 degrees and 90 degrees.

[0080] Illustrative Example 4. A freezing probe according to any one of Illustrative Examples 1 to 3, wherein the handle includes a deformable member configured to maintain multiple positions of the probe relative to a refrigerant line.

[0081] Illustrative Example 5. A freezing probe according to any one of Illustrative Examples 1 to 4, wherein the handle includes: a flexible outer member defining an inner cavity; and a deformable inner member positioned in the inner cavity, the deformable inner member being configured to maintain the position of the probe relative to a refrigerant line.

[0082] Illustrative Example 6. A cryogenic probe according to Illustrative Example 5, wherein the flexible outer member and the deformable inner member each have a cylindrical shape.

[0083] Illustrative Example 7. A freezing probe according to any one of Illustrative Examples 5 or 6, wherein the handle further includes a refrigerant supply tube located in the inner cavity and radially inside the deformable inner member.

[0084] Illustrative Example 8. A freezing probe according to Illustrative Example 7, wherein a deformable internal component and a refrigerant supply tube define a refrigerant flow path in which refrigerant flows through the refrigerant supply tube toward the tip of the needle and flows away from the tip of the needle in the space between the outer surface of the refrigerant supply tube and the inner surface of the deformable internal component.

[0085] Illustrative Example 9. A cryoprobe according to any one of illustrative Examples 5 to 8, wherein the handle further includes a limiting member positioned in the cavity radially outside the deformable inner member, the limiting member being configured to limit bending of the handle.

[0086] Illustrative Example 10. A freezing probe according to any one of Illustrative Examples 1 to 9, wherein the handle includes a refrigerant supply line and an outer flexible member, the outer flexible member including at least one embedded wire configured to maintain the position of the probe relative to the refrigerant line.

[0087] Illustrative Example 11. A cryoprobe according to Illustrative Example 10, wherein at least one embedded wire comprises a plurality of embedded wires.

[0088] Illustrative Example 12. A cryoprobe according to any one of Illustrative Examples 10 or 11, wherein each of a plurality of embedded wires is equally spaced around the circumference of an outer flexible member.

[0089] Illustrative Example 13. A freezing probe according to any one of Illustrative Examples 1 to 3, wherein the handle includes: a flexible outer member; and a deformable member configured to maintain the position of the probe relative to the refrigerant line.

[0090] Illustrative Example 14. A cryoprobe according to any one of illustrative Examples 5 to 13, wherein the flexible outer member includes at least one longitudinal reinforcement configured to restrict bending of the flexible outer member in at least one plane.

[0091] Illustrative Example 15. A cryoprobe according to Illustrative Example 14, wherein at least one longitudinal reinforcement includes a first reinforcement and a second reinforcement, the first reinforcement and the second reinforcement being positioned on opposite sides of a flexible outer member, the first reinforcement and the second reinforcement including enlarged portions of the flexible outer member wall.

[0092] Illustrative Example 16. A freezing probe according to any one of Illustrative Examples 1 to 15, wherein the handle is configured to bend in a plurality of planes relative to the axis of the refrigerant line.

[0093] Illustrative Example 17. A freezing probe according to any one of Illustrative Examples 1 to 16, wherein the handle is configured to bend in at least two orthogonal planes relative to the axis of the refrigerant line.

[0094] Illustrative Example 18. A freezing probe according to any of the foregoing illustrative embodiments, wherein the handle includes a deformable member configured to permanently deform to maintain the position of the probe relative to the refrigerant line.

[0095] Illustrative Example 19. A cryoablation system comprising: a cryoprobe according to any of the foregoing illustrative embodiments; and a cryoablation delivery device configured to deliver a refrigerant to the cryoprobe.

[0096] Illustrative Example 20. A method of using a cryoprobe, comprising: positioning the cryoprobe of any of the preceding illustrative embodiments at a target tissue; bending the handle of the cryoprobe from a first position to a second position to orient the refrigerant line relative to the needle at a desired location; and initiating the flow of refrigerant to the cryoprobe while the handle is in the second position.

[0097] The foregoing description of the embodiments is provided for illustrative purposes and is not intended to be exhaustive or limiting. Various elements or features of a particular embodiment are generally not limited to that particular embodiment, but are interchangeable and may be used in selected embodiments where applicable, even if not specifically shown or described. Likewise, it may be varied in many ways. Such variations should not be considered as departing from this disclosure, and all such modifications are intended to be included within the scope of this disclosure.

Claims

1. A cryoprobe, comprising: Needle; as well as A handle is configured to fluidly couple the needle to a refrigerant line, and the handle is configured to bend to change the position of the needle relative to the refrigerant line.

2. The cryogenic probe of claim 1, wherein the handle is configured to bend from a first position to a second position, in the first position, the longitudinal axis of the needle is aligned with the longitudinal axis of the refrigerant supply line, and in the second position, the longitudinal axis of the needle is positioned at an angle relative to the longitudinal axis of the refrigerant supply line.

3. The cryoprobe according to claim 2, wherein the angle of the second position of the cryoprobe is in the range of 180 degrees and 90 degrees.

4. The cryogenic probe of claim 1, wherein the handle includes a deformable member configured to maintain the probe in multiple positions relative to the refrigerant line.

5. The cryoprobe of claim 1, wherein the handle comprises: Flexible outer components define the internal cavity; as well as A deformable internal member is positioned within the cavity and is configured to maintain the position of the needle relative to the refrigerant line.

6. The cryogenic probe of claim 5, wherein the flexible outer member and the deformable inner member each have a cylindrical shape.

7. The freezing probe of claim 5, wherein the handle further comprises a refrigerant supply tube positioned radially inside the cavity and on the deformable inner side of the internal member.

8. The cryogenic probe of claim 7, wherein the deformable internal member and the refrigerant supply tube define a refrigerant flow path in which refrigerant flows through the refrigerant supply tube toward the tip of the needle and flows away from the tip of the needle in the space between the outer surface of the refrigerant supply tube and the inner surface of the deformable internal member.

9. The cryoprobe of claim 5, wherein the handle further comprises a limiting member positioned within the cavity and radially outside the deformable inner member, the limiting member being configured to limit bending of the handle.

10. The cryogenic probe of claim 1, wherein the handle comprises a refrigerant supply line and an external flexible member, the external flexible member comprising at least one embedded wire configured to maintain the position of the probe relative to the refrigerant line.

11. The cryoprobe of claim 10, wherein the at least one embedded wire comprises a plurality of embedded wires.

12. The cryoprobe of claim 11, wherein each of the plurality of embedded wires is equidistantly spaced around the circumference of the outer flexible member.

13. The cryoprobe of claim 1, wherein the handle comprises: Flexible external components; as well as A deformable member is configured to maintain the position of the needle relative to the refrigerant line.

14. The cryoprobe of claim 13, wherein the flexible outer member includes at least one longitudinal reinforcement configured to restrict bending of the flexible outer member in at least one plane.

15. The cryoprobe of claim 14, wherein the at least one longitudinal reinforcement comprises a first reinforcement and a second reinforcement positioned on opposite sides of the flexible outer member, the first reinforcement and the second reinforcement comprising enlarged portions of the wall of the flexible outer member.

16. The freezing probe of claim 1, wherein the handle is configured to bend in a plurality of planes relative to the axis of the refrigerant line.

17. The freezing probe of claim 1, wherein the handle is configured to bend in at least two orthogonal planes relative to the axis of the refrigerant line.

18. The cryogenic probe of claim 1, wherein the handle includes a deformable member configured to permanently deform to maintain the position of the probe relative to the refrigerant line.

19. A cryoablation system, comprising: The cryoprobe according to claim 1; as well as A cryoablation delivery device is configured to deliver refrigerant to the cryoprobe.

20. A method for using a cryoprobe, comprising: Position the cryoprobe according to claim 1 at the target tissue; The handle of the cryogenic probe is bent from a first position to a second position so that the refrigerant line is oriented relative to the needle at a desired location; and When the handle is in the second position, the flow of refrigerant to the freezing probe is initiated.

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