Cryoablation catheter with varying cross-sectional shape

By designing a cross-sectional shape of the proximal cryogenic shaft and the distal cryogenic shaft in the cryoablation catheter, the exhaust area is increased, and the problem of insufficient exhaust in the existing cryoablation catheter is solved and the treatment effect is improved.

CN120302935APending Publication Date: 2025-07-11MEDTRONIC IRELAND MFG UNLIMITED CO
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Patent Information

Application Number
CN202380078717.5
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Priority Date
2022-11-18
Filing Date
2023-11-07
Publication Date
2025-07-11

AI Technical Summary

Technical Problem

The existing cryoablation catheters have insufficient exhaust area in cryoablation treatment, resulting in poor control of intra-balloon pressure and temperature.

Method used

A cryoablation catheter is designed in which the cross-sectional shape of the proximal cryogenic shaft is different from the distal cryogenic shaft, increasing the exhaust area and providing tighter balloon profile and enhanced structural support through the proximal cryogenic shaft.

Benefits of technology

The performance of the cryoablation catheter is improved, and the pressure and temperature in the balloon is reduced by increasing the exhaust area, achieving more precise treatment effects.

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Abstract

A cryoablation catheter includes a distal cryogenic shaft having a first cross-sectional shape, an inflatable balloon coupled to the distal cryogenic shaft, and a proximal cryogenic shaft having a second cross-sectional shape. The second cross-sectional shape is different from the first cross-sectional shape. The distal cryogenic shaft is coupled to the proximal cryogenic shaft at a quick-change joint. The cryoablation catheter also includes an inner flow tube disposed within both the proximal cryogenic shaft and the distal cryogenic shaft. The inner flow tube is coupled to the inflatable balloon.
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Description

Technical Field

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 384,270, filed on November 18, 2022, the entire content of which is incorporated herein by reference. Background Art

[0002] The technology of the present disclosure generally relates to cryoablation catheters.

[0003] Renal denervation and similar balloon cryotherapies are performed by using a refrigerant to expand a balloon to remove heat from surrounding tissue. The balloon is supported by a catheter that supplies the refrigerant to the balloon to perform the treatment. Introducing the refrigerant into the balloon causes the balloon to expand, and the temperature inside the balloon is monitored throughout the treatment. The catheter includes a distal portion connected to the balloon to supply the refrigerant and a proximal portion connected to the distal portion to supply the refrigerant from a refrigerant reservoir. Summary of the Invention

[0004] The technology of the present disclosure generally relates to the use of a proximal cryogenic shaft of a cryoablation catheter having a cross-sectional shape different from that of a distal cryogenic shaft of the cryoablation catheter. The cross-sectional shape of the proximal cryogenic shaft can maximize additional space and increase the exhaust area of the cryoablation catheter for improved performance during cryoablation treatment. The cross-sectional shape of the proximal cryogenic shaft can also improve the overall structural support of the proximal cryogenic shaft by providing a larger outer diameter and a larger inner diameter of the proximal cryogenic shaft and allowing for a tighter balloon profile during cryoablation treatment. The smaller diameter from the baseline of the distal cryogenic shaft to the diameter of the inner flow tube of the distal cryogenic shaft and the larger diameter of the proximal cryogenic shaft allow for a balloon of a smaller volume with a similar profile. The pressure and temperature inside the balloon are reduced due to the increased exhaust area of the proximal cryogenic shaft, and the increased exhaust area provides a smaller balloon volume corresponding to a tighter balloon profile.

[0005] In one aspect, the present disclosure provides a cryoablation catheter that includes a distal cryogenic shaft having a first cross-sectional shape, an expandable balloon coupled to the distal cryogenic shaft, and a proximal cryogenic shaft having a second cross-sectional shape. The second cross-sectional shape is different from the first cross-sectional shape. The distal cryogenic shaft is coupled to the proximal cryogenic shaft at a rapid exchange fitting. The cryoablation catheter further includes an inner flow tube disposed within both the proximal cryogenic shaft and the distal cryogenic shaft. The inner flow tube is coupled to the expandable balloon.

[0006] The present disclosure also discloses a cryoablation catheter, which includes a distal cryogenic shaft having a first cross-sectional shape, an expandable balloon coupled to the distal cryogenic shaft, and a proximal cryogenic shaft having a second cross-sectional shape, wherein the second cross-sectional shape is different from the first cross-sectional shape, wherein the distal cryogenic shaft is coupled to the proximal cryogenic shaft at a rapid exchange connector, wherein the cryoablation catheter further includes an inner flow tube disposed within both the proximal cryogenic shaft and the distal cryogenic shaft, and wherein the inner flow tube is coupled to the expandable balloon.

[0007] Details of one or more aspects of the present disclosure are set forth in the following drawings and description. Other features, objects, and advantages of the techniques described in the present disclosure will be apparent from the description, drawings, and claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] Figure 1 is a perspective view of a cryoablation catheter according to an example.

[0009] Figure 2 is Figure 1 a close-up perspective view of the distal cryogenic shaft of the cryoablation catheter and the rapid exchange connector.

[0010] Figure 3 is a close-up perspective view of the rapid exchange connector.

[0011] Figure 4 is a schematic front cross-sectional view of the cryoablation catheter, illustrating the distal cryogenic shaft.

[0012] Figure 5 is a schematic front cross-sectional view of the cryoablation catheter, illustrating the proximal cryogenic shaft.

[0013] Figure 6 is a close-up perspective view of the rapid exchange connector and the proximal cryogenic shaft according to another example, the proximal cryogenic shaft having a cross-sectional shape different from the cross-sectional shape of the distal cryogenic shaft.

[0014] Figures 7A to 7C is a schematic front cross-sectional view of the cryoablation catheter, illustrating different cross-sectional shapes of the proximal cryogenic shaft according to different examples.

[0015] Figure 8 is a schematic front cross-sectional view of the cryoablation catheter, illustrating a comparison of the cross-sectional shapes of the proximal cryogenic shaft.

[0016] Figure 9 is a schematic system view of the cryoablation catheter. DETAILED DESCRIPTION

[0017] Reference Figures 1 to 5, A medical device exemplified as a cryoablation catheter 100 includes a handle 105, a proximal cryogenic shaft 110 coupled to the handle 105, and a distal cryogenic shaft 115 coupled to the proximal cryogenic shaft 110. The distal cryogenic shaft 115 is sized to be inserted into the vasculature of a patient. The distal cryogenic shaft 115 is coupled to the proximal cryogenic shaft 110 at a rapid exchange fitting 120. The rapid exchange fitting 120 is positioned to secure the proximal cryogenic shaft 110 to the distal cryogenic shaft 115 while maintaining the components of the cryoablation catheter 100 in transition between the proximal cryogenic shaft 110 and the distal cryogenic shaft 115.

[0018] Continuing to refer Figures 1 to 5 , In the exemplified example, the cryoablation catheter 100 further includes a guidewire 125. The guidewire 125 is shaped to ensure proper alignment of the components of the cryoablation catheter 100 through the proximal cryogenic shaft 110 and the distal cryogenic shaft 115. The cryoablation catheter 100 further includes an inner member 130. A portion of the guidewire 125 extends through the inner member 130. The inner member 130 can extend to the distal end of the cryoablation catheter 100 and can be partially surrounded by a balloon 135 at the distal end of the cryoablation catheter 100. In the exemplified example, the balloon 135 is coupled to the distal cryogenic shaft 115 and can be selectively inflated to perform cryoablation therapy. The cryoablation catheter 100 delivers a refrigerant to the balloon 135 (e.g., through a port) to inflate and cool the balloon 135 during cryoablation therapy. The inner member 130 can include a first portion disposed within the distal cryogenic shaft 115 and a second portion extending outside the distal cryogenic shaft 115 (e.g., as Figure 3 exemplified extending proximally into a portion of the distal cryogenic shaft 115). Although Figure 3 the inner member 130 is exemplified as extending proximally out of the rapid exchange fitting 120, in some examples, the inner member 130 can be trimmed or otherwise modified such that the inner member 130 does not extend proximally out of the rapid exchange fitting 120.

[0019] Refer Figures 3 to 5 , The guidewire 125 of the exemplified example includes a first portion 125a disposed within the distal cryogenic shaft 115 (e.g., disposed within the portion of the inner member 130 that is within the distal cryogenic shaft 115) and a second portion 125b disposed outside both the distal cryogenic shaft 115 and the proximal cryogenic shaft 110. The guidewire 125 transitions from the first portion 125a to the second portion 125b at the rapid exchange fitting 120. As Figure 3 exemplified, the first portion 125a of the guidewire 125 extends through the first portion of the inner member 130 within the distal cryogenic shaft 115, and the second portion 125b of the guidewire 125 extends proximally beside the proximal cryogenic shaft 110 out of the second portion of the inner member 130.

[0020] Continue to refer to Figure 3 , a portion of the inner member 130 extends along a first longitudinal axis A1. The distal cryoaxis 115 extends along a second longitudinal axis A2. The second longitudinal axis A2 extends between the balloon 135 and the rapid exchange connector 120. The proximal cryoaxis 110 extends along a third longitudinal axis A3. The third longitudinal axis A3 extends between the rapid exchange connector 120 and the handle 105. In some examples, the first longitudinal axis A1 is parallel to both the second longitudinal axis A2 and the third longitudinal axis A3. In some examples, the second longitudinal axis A2 is collinear with the third longitudinal axis A3. Additionally, in some examples, the rapid exchange connector 120 further includes an elastomeric sheath 140. The elastomeric sheath 140 extends over the proximal cryoaxis 110 and the distal cryoaxis 115 to ensure a connection is formed by the rapid exchange connector 120 between the proximal cryoaxis 110 and the distal cryoaxis 115. The elastomeric sheath 140 provides a sealing protection for the rapid exchange connector 120 such that the proximal cryoaxis 110 and the distal cryoaxis 115 are not exposed to contaminants during cryoablation therapy.

[0021] Refer to Figure 4 and Figure 5 , the proximal cryoaxis 110 and the distal cryoaxis 115 may each be disposed within the outer catheter shaft 160. In the illustrated example and referring to Figure 4 , the first cross-sectional shape of the distal cryoaxis 115 has a height measured along a first direction D1 and a width measured along a second direction D2. The second direction D2 is perpendicular to the first direction D1. In some examples, the height of the first cross-sectional shape is the same as the width of the first cross-sectional shape (e.g., the first cross-sectional shape is a circular cross-sectional shape). In other examples, the height of the first cross-sectional shape is different from the width of the first cross-sectional shape. As Figure 4As illustrated, the distal cryogenic shaft 115 may house a guidewire 125, an inner member 130, an inflow tube 165, a thermocouple wire 170, and a pressure tube 175. In some examples, the distal cryogenic shaft 115 may include more or fewer components than those listed. As described above, the guidewire 125 is disposed within the inner member 130 within the distal cryogenic shaft 115 (e.g., a first portion 125a of the guidewire 125 extends through the inner member 130 within the distal cryogenic shaft 115). The inflow tube 165 may introduce a refrigerant during cryoablation therapy and may extend to a location within the balloon 135. In some examples, the inflow tube 165 may include a plurality of inflow ports (not shown) that deliver the refrigerant to a volume of space within the balloon 135 during use. The inflow ports are, for example, radial openings in the inflow tube 165 and direct the refrigerant radially outwardly toward the balloon 135. The refrigerant flows as a liquid through the inflow tube 165 of the distal cryogenic shaft 115 and undergoes a liquid-to-gas phase change as it passes through the inflow ports and into the balloon 135. The phase change causes the now gaseous refrigerant to rapidly expand, thereby reducing the temperature within the balloon 135 and causing the balloon 135 to expand (e.g., near the distal end of the cryoablation catheter 100). Due to the precise nature of cryoablation therapy, the thermocouple wire 170 (i.e., the TC wire) may be disposed within the balloon 135 and extend through the distal cryogenic shaft 115 to allow monitoring of the internal temperature of the balloon 135. The pressure tube 175, which includes a pressure sensor, may be disposed within the balloon 135 and extend through the distal cryogenic shaft 115 to allow monitoring of the internal pressure of the balloon 135. The guidewire 125 and the inner member 130 may align and secure the inflow tube 165, the TC wire 170, and the pressure tube 175 within the distal cryogenic shaft 115.

[0022] Reference Figure 5 , in some examples, a portion of the proximal cryogenic shaft 110 has the same cross-sectional shape as the distal cryogenic shaft 115. When the guidewire 125 transitions from the first portion 125a to the second portion 125b through the rapid exchange fitting 120, the second portion 125b is positioned between the proximal cryogenic shaft 110 and the outer catheter shaft 160. Positioning the second portion 125b of the guidewire 125 between the proximal cryogenic shaft 110 and the outer catheter shaft 160 allows for greater space for the internal components of the proximal cryogenic shaft 110 and provides a hollow internal cavity 180. The proximal cryogenic shaft 110 may also house the inflow tube 165, the thermocouple wire 170, and the pressure tube 175. In some examples, the proximal cryogenic shaft 110 may include more or fewer components than those listed. The hollow internal cavity 180 allows the proximal cryogenic shaft 110 to convey exhaust gas from the cryoablation therapy proximally out of the cryoablation catheter 100.

[0023] While Figures 1 to 5Illustrated is a proximal cryogenic shaft 110 having a circular cross-sectional shape that matches the circular cross-sectional shape of the distal cryogenic shaft 115, but the cross-sectional shape of the proximal cryogenic shaft 110 may be different from the cross-sectional shape of the distal cryogenic shaft 115. For example, and referring to Figures 6 to 8 , the proximal cryogenic shaft 110 may have a non-circular shape (e.g., crescent shape, flat top shape, rectangular and / or swaged shape or other shape). Compared to the circular shape in Figures 1 to 5 , this shape may allow a greater amount of exhaust gas to be conveyed out of the cryoablation catheter 100.

[0024] Referring to Figure 6 , in some examples, the quick-exchange fitting 120 includes an elongate tubular member 185 having an angled wall 190. The tubular member 185 may be coupled to both the proximal cryogenic shaft 110 and the distal cryogenic shaft 115, or may be integrally formed as part of one or both of the proximal cryogenic shaft 110 and the distal cryogenic shaft 115. In some examples, the angled wall 190 extends at an angle with respect to the first longitudinal axis A1 to connect the proximal cryogenic shaft 110 with the distal cryogenic shaft 115 via the quick-exchange fitting 120.

[0025] Continuing to refer to Figure 6 , in the illustrated example, the inner member 130 (and the guidewire 125 therein) passes through the elongate tubular member 185 and the angled wall 190. The cross-sectional shape of the proximal cryogenic shaft 110 may be a crescent shape and / or have an outer surface defining a groove 155. The inner member 130 (and the second portion 125b of the guidewire 125 therein) may be at least partially disposed within the groove 155. In some examples, the groove 155 at least partially defines the cross-sectional shape of the proximal cryogenic shaft 110 such that the second portion 125b of the guidewire 125 extends parallel to the proximal cryogenic shaft 110 along the first longitudinal axis A1.

[0026] Referring to Figures 7A to 7C And as described above, the cross-sectional shape of the proximal cryogenic shaft 110 may be any one of a variety of different cross-sectional shapes. Figures 7A to 7C Illustrated are various examples of proximal cryogenic shafts 110a, 110b, 110c, and 110d having different shapes. Each shape has a height measured along a first direction D1 and a width measured along a second direction D2. The second direction D2 is perpendicular to the first direction D1. In some examples, the width of the second cross-sectional shape is greater than the height of the second cross-sectional shape (e.g., the second cross-sectional shape of the proximal cryogenic shaft 110 is a non-circular cross-sectional shape). As Figures 7A to 7CAs illustrated, the guide wire 125 is positioned between each of the proximal cryo shafts 110a, 110b, 110c, 110d and the outer catheter shaft 160. In the illustrated example, the proximal cryo shaft 110a has a flat top cross-sectional shape. In contrast, the proximal cryo shaft 110b has a crescent-shaped cross-sectional shape. In contrast, the proximal cryo shaft 110d has an oval (e.g., swaged) cross-sectional shape. In some examples, the cross-sectional shape is an oval cross-sectional shape. In some examples, the cross-sectional shape remains constant along the entire proximal cryo shaft 110. In other examples, the cross-sectional shape of the proximal cryo shaft 110 changes along the proximal cryo shaft 110. For example, in some examples, as the proximal cryo shaft 110 extends towards the rapid exchange fitting 120, the cross-sectional shape can change from a circular shape (proximal cryo shaft 110c) to an oval (e.g., swaged) shape (proximal cryo shaft 110d).

[0027] Reference Figure 8 , and Figures 1 to 5 compared to the proximal cryo shafts shown in, these different cross-sectional shapes of the proximal cryo shaft 110 increase the exhaust area within the proximal cryo shaft 110 to convey the exhaust gas. The increased exhaust area can improve the performance of the cryoablation catheter 100 during cryoablation therapy. For example, the larger exhaust area can provide a greater vacuum power to reduce the pressure and temperature within the balloon 135 during cryoablation therapy. As Figure 8 shown, the guide wire 125 is positioned between the proximal cryo shaft 110 of different second cross-sectional shapes and the outer catheter shaft 160. The flat top shape 110a and the crescent shape 110b are shown compared to the standard circular cross-sectional shape of the proximal cryo shaft 110. Figures 1 to 5 The standard circular cross-sectional shape of the proximal cryo shaft 110 in may have an outer diameter of, for example, 0.040". The flat top shape of the modified proximal cryo shaft 110a can increase the overall dimensions of the proximal cryo shaft 110, thereby increasing the exhaust area within the proximal cryo shaft 210a. In some examples, the flat top shape can provide a 64% increase in the exhaust area, or for example, an increase in the exhaust area between 60% and 70%. The crescent shape 110b can provide an 80% increase in the exhaust area, or for example, an increase in the exhaust area between 70% and 90%. Although not shown, the oval (e.g., swaged) shape can provide a 20% increase in the exhaust area, or for example, an increase in the exhaust area between 10% and 30%. Other examples include other values and ranges of values for the increased exhaust area.

[0028] In some examples, different (and, for example, larger) cross-sectional shapes of the proximal cryoaxis 110 can improve the overall structural support of the proximal cryoaxis 110 (e.g., by providing a larger outer diameter and a larger inner diameter of the proximal cryoaxis 110 and allowing a tighter balloon profile during cryoablation therapy). The pressure and temperature within the balloon 135 can be reduced due to the increased exhaust area of the proximal cryoaxis 110.

[0029] Reference Figure 9 , the cryoablation catheter 100 can be used in a variety of settings and can be used in combination with one or more of the handle 105 and the control device 900. In some examples, the proximal cryoaxis 110 is coupled to the handle 105. The handle 105 is coupled to the control device 900 (e.g., via wiring for delivering the refrigerant and / or one or more conduits). The handle 105 can include one or more valves (e.g., check valves), or other features that control the movement of the refrigerant flowing through the inner flow tube 165 and / or control the movement of one or more portions of the cryoablation catheter 100 itself. In some examples, the handle 105 is not provided. Instead, the proximal cryoaxis 110 of the cryoablation catheter 100 is (e.g., directly) coupled to the control device 900. In some examples, the control device 900 is a large, standalone reusable console (e.g., having a reservoir for the refrigerant, a vent for the refrigerant, a display or monitor, and / or other features). In other examples, the control device 900 is a smaller, reusable console (e.g., without a full display or monitor, but having onboard electronics to control the flow of the refrigerant and having a reservoir for the refrigerant or a connector for connecting to a refrigerant container). In other examples, the control device 900 is a disposable handheld device for controlling the flow of the refrigerant and can include, for example, a connector for connecting to a refrigerant container.

[0030] It should be understood that the various aspects disclosed herein can be combined in combinations different from those specifically presented in the specification and the drawings. It should also be understood that, depending on the example, certain actions or events of any of the processes or methods described herein can be performed in a different order, can be completely added, combined, or omitted (e.g., not all of the described actions or events may be required to perform the techniques). Additionally, although certain aspects of the present disclosure are described as being performed by a single module or unit for clarity, it should be understood that the techniques of the present disclosure can be performed by a combination of units or modules associated with, for example, a medical device.

[0031] Although the various aspects and examples have been described in detail with reference to certain examples illustrated in the drawings, there are variations and modifications within the scope and spirit of one or more of the described and illustrated individual aspects.

[0032] Example 1. A cryoablation catheter, the cryoablation catheter comprising: a distal cryogenic shaft having a first cross-sectional shape; an expandable balloon coupled to the distal cryogenic shaft; a proximal cryogenic shaft having a second cross-sectional shape, wherein the second cross-sectional shape is different from the first cross-sectional shape, and wherein the distal cryogenic shaft is coupled to the proximal cryogenic shaft at a rapid exchange fitting; and an inflow tube disposed within the proximal cryogenic shaft and the distal cryogenic shaft, wherein the inflow tube is coupled to the expandable balloon.

[0033] Example 2. The cryoablation catheter according to Example 1, wherein the first cross-sectional shape is a circular cross-sectional shape, and wherein the second cross-sectional shape is a non-circular cross-sectional shape.

[0034] Example 3. The cryoablation catheter according to Example 1 or any one of Examples 1 or 2, wherein the second cross-sectional shape has a height measured along a first direction and a width measured along a second direction perpendicular to the first direction, wherein the width is greater than the height.

[0035] Example 4. The cryoablation catheter according to Example 1 or any one of Examples 1 to 3, wherein the second cross-sectional shape defines an ellipse.

[0036] Example 5. The cryoablation catheter according to Example 1 or any one of Examples 1 to 3, wherein the second cross-sectional shape is a crescent shape.

[0037] Example 6. The cryoablation catheter according to Example 1 or any one of Examples 1 to 5, the cryoablation catheter further comprising an internal member having a first portion disposed within the distal cryogenic shaft and a second portion disposed outside the distal cryogenic shaft.

[0038] Example 7. The cryoablation catheter according to Example 6, the cryoablation catheter further comprising a guide wire having a first portion disposed within the distal cryogenic shaft and a second portion disposed outside both the distal cryogenic shaft and the proximal cryogenic shaft, wherein the guide wire transitions from the first portion to the second portion at the rapid exchange fitting, wherein the first portion of the guide wire extends through the first portion of the internal member, and wherein the second portion of the guide wire extends proximally out of the second portion of the internal member.

[0039] Example 8. The cryoablation catheter according to Example 7, wherein the rapid exchange fitting includes an elongate tubular member coupled to both the distal cryogenic shaft and the proximal cryogenic shaft, wherein the elongate tubular member includes an inclined wall, and wherein the internal member extends through the inclined wall.

[0040] Example 9. The cryoablation catheter according to Example 8, wherein the inner member extends along a longitudinal axis, and wherein the inclined wall extends at an oblique angle relative to the longitudinal axis.

[0041] Example 10. The cryoablation catheter according to Example 9, wherein the longitudinal axis is a first longitudinal axis, wherein the distal cryogenic axis extends along a second longitudinal axis and the proximal cryogenic axis extends along a third longitudinal axis, and wherein the first longitudinal axis is parallel to both the second longitudinal axis and the third longitudinal axis.

[0042] Example 11: The cryoablation catheter according to Example 1 or any one of Examples 1 to 10, wherein the rapid exchange connector includes an elastomeric sheath that extends over both the distal cryogenic axis and the proximal cryogenic axis.

[0043] Example 12. The cryoablation catheter according to Example 1 or any one of Examples 1 to 11, wherein the second cross-sectional shape changes along at least a portion of the proximal cryogenic axis.

[0044] Example 13. The cryoablation catheter according to Example 1 or any one of Examples 1 to 11, wherein the second cross-sectional shape remains constant along the entire proximal cryogenic axis.

[0045] Example 14. The cryoablation catheter according to Example 1 or any one of Examples 1 to 6, the cryoablation catheter further comprising a guide wire having a first portion disposed within the distal cryogenic axis and a second portion disposed outside both the distal cryogenic axis and the proximal cryogenic axis, wherein the guide wire transitions from the first portion to the second portion at the rapid exchange connector, and wherein the second portion of the guide wire extends parallel to the proximal cryogenic axis.

[0046] Example 15. The cryoablation catheter according to Example 14, wherein the proximal cryogenic axis has an outer surface defining a groove, and wherein the second portion of the guide wire is at least partially disposed within the groove.

[0047] Example 16. The cryoablation catheter according to Example 1 or any one of Examples 1 to 15, the cryoablation catheter further comprising an outer catheter shaft, wherein the distal cryogenic axis and the proximal cryogenic axis are each disposed within the outer catheter shaft.

[0048] Example 17. The cryoablation catheter according to Example 16, further comprising a guide wire having a first portion disposed within the distal cryogenic shaft and a second portion disposed exteriorly of both the distal cryogenic shaft and the proximal cryogenic shaft, wherein the guide wire transitions from the first portion to the second portion at the rapid exchange fitting, and wherein the second portion of the guide wire is positioned between the proximal cryogenic shaft and the outer catheter shaft.

[0049] Example 18. The cryoablation catheter according to Example 1 or any one of Examples 1 to 17, further comprising a thermocouple wire disposed within both the proximal cryogenic shaft and the distal cryogenic shaft.

[0050] Example 19. The cryoablation catheter according to Example 1 or any one of Examples 1 to 18, wherein a portion of the proximal cryogenic shaft has the same cross-sectional shape as a portion of the distal cryogenic shaft.

[0051] Example 20. The cryoablation catheter according to Example 1 or any one of Examples 1 to 19, wherein the proximal cryogenic shaft defines a hollow inner cavity configured to convey exhaust proximally out of the cryoablation catheter.

Claims

1. A cryoablation catheter, the cryoablation catheter comprising: A distal cryogenic shaft having a first cross-sectional shape; An inflatable balloon coupled to the distal cryogenic shaft; A proximal cryogenic shaft having a second cross-sectional shape, wherein the second cross-sectional shape is different from the first cross-sectional shape, and wherein the distal cryogenic shaft is coupled to the proximal cryogenic shaft at a rapid exchange connector; And An inflow tube disposed within both the proximal cryogenic shaft and the distal cryogenic shaft, wherein the inflow tube is coupled to the inflatable balloon.

2. The cryoablation catheter according to claim 1, wherein the first cross-sectional shape is a circular cross-sectional shape, and wherein the second cross-sectional shape is a non-circular cross-sectional shape.

3. The cryoablation catheter according to claim 1 or 2, wherein the second cross-sectional shape has a height measured along a first direction and a width measured along a second direction perpendicular to the first direction, wherein the width is greater than the height.

4. The cryoablation catheter according to any one of claims 1 to 3, wherein the second cross-sectional shape defines an ellipse.

5. The cryoablation catheter according to any one of claims 1 to 3, wherein the second cross-sectional shape is a crescent shape.

6. The cryoablation catheter according to any one of claims 1 to 5, the cryoablation catheter further comprising an internal member having a first portion disposed within the distal cryogenic shaft and a second portion disposed external to the distal cryogenic shaft.

7. The cryoablation catheter according to claim 6, the cryoablation catheter further comprising a guide wire having a first portion disposed within the distal cryogenic shaft and a second portion disposed external to both the distal cryogenic shaft and the proximal cryogenic shaft, wherein the guide wire transitions from the first portion to the second portion at the rapid exchange connector, wherein the first portion of the guide wire extends through the first portion of the internal member, and wherein the second portion of the guide wire extends proximally out of the second portion of the internal member.

8. The cryoablation catheter according to claim 7, wherein the rapid exchange connector includes an elongate tubular member coupled to both the distal cryogenic shaft and the proximal cryogenic shaft, wherein the elongate tubular member includes an angled wall, and wherein the internal member extends through the angled wall.

9. The cryoablation catheter according to claim 8, wherein the internal member extends along a longitudinal axis, and wherein the angled wall extends at an oblique angle relative to the longitudinal axis.

10. The cryoablation catheter according to claim 9, wherein the longitudinal axis is a first longitudinal axis, wherein the distal cryogenic shaft extends along a second longitudinal axis and the proximal cryogenic shaft extends along a third longitudinal axis, wherein the first longitudinal axis is parallel to both the second longitudinal axis and the third longitudinal axis.

11. The cryoablation catheter according to any one of claims 1 to 10, wherein the rapid exchange adapter includes an elastomeric sheath that extends over both the distal cryoaxis and the proximal cryoaxis.

12. The cryoablation catheter according to any one of claims 1 to 11, wherein the second cross-sectional shape changes along at least a portion of the proximal cryoaxis.

13. The cryoablation catheter according to any one of claims 1 to 11, wherein the second cross-sectional shape remains constant along the entire proximal cryoaxis.

14. The cryoablation catheter according to any one of claims 1 to 6, the cryoablation catheter further comprising a guide wire having a first portion disposed within the distal cryoaxis and a second portion disposed external to both the distal cryoaxis and the proximal cryoaxis, wherein the guide wire transitions from the first portion to the second portion at the rapid exchange adapter, and wherein the second portion of the guide wire extends parallel to the proximal cryoaxis.

15. The cryoablation catheter according to claim 14, wherein the proximal cryoaxis has an outer surface defining a groove, and wherein the second portion of the guide wire is at least partially disposed within the groove.

16. The cryoablation catheter according to any one of claims 1 to 15, the cryoablation catheter further comprising an outer catheter shaft, wherein the distal cryoaxis and the proximal cryoaxis are each disposed within the outer catheter shaft.

17. The cryoablation catheter according to claim 16, the cryoablation catheter further comprising a guide wire having a first portion disposed within the distal cryoaxis and a second portion disposed external to both the distal cryoaxis and the proximal cryoaxis, wherein the guide wire transitions from the first portion to the second portion at the rapid exchange adapter, and wherein the second portion of the guide wire is positioned between the proximal cryoaxis and the outer catheter shaft.

18. The cryoablation catheter according to any one of claims 1 to 17, the cryoablation catheter further comprising a thermocouple wire disposed within both the proximal cryoaxis and the distal cryoaxis.

19. The cryoablation catheter according to any one of claims 1 to 18, wherein a portion of the proximal cryoaxis has the same cross-sectional shape as a portion of the distal cryoaxis.

20. The cryoablation catheter according to any one of claims 1 to 19, wherein the proximal cryoaxis defines a hollow internal cavity configured to convey exhaust gas proximally out of the cryoablation catheter.