Bubble removal for intra-rectal cooling devices

Abstract

An intrarectal cooling device (ECD) includes an elongate body, a cooling fluid circuit, and a bubble removal device. The elongate body includes an insertable portion for insertion into a rectum of a patient and an outer portion retained outside of the rectum. A cooling fluid circuit is defined in the elongate body from the outer portion to the insertable portion and circulates a cooling fluid to regulate a temperature of the cooling surface on the insertable portion. The bubble removal device may include coils, tubes, nets, and / or apertures disposed on or defined within an insertable portion of the elongate body (e.g., a cooling surface). A low pressure source, such as a vacuum pump or venturi structure, may be fluidly coupled to the bubble removal device to remove fluid and bubbles by suction after insertion of the ECD into the rectum.

Description

[0001] This application is a divisional application of a Chinese patent application filed on November 15, 2019, with application number 201980101454.9 and titled “Bubble Removal for Intrarectal Cooling Device”. Technical Field

[0002] The present application relates generally to devices for controlling the temperature of a body cavity and surrounding tissue, and more particularly to devices for controlling temperature in the context of thermal therapy applied to an organ or tissue proximate the cavity. Background Art

[0003] During thermal treatment of the prostate, energy is delivered from an energy delivery device to eliminate or reduce diseased cells in the prostate. An undesirable side effect of heating diseased tissue may be overheating of adjacent non-diseased tissues and organs. For example, in thermal treatment of the prostate, the rectum and other healthy tissues near the prostate may be heated to temperatures that exceed what is safe or healthy for the patient. It is desirable to limit the thermal dose or maximum temperature applied to these tissues (e.g., the rectal wall near the prostate).

[0004] Endorectal cooling devices (ECDs) can be used to maintain the temperature of the rectum and surrounding tissue at a safe level. These devices typically include an elongated body and an internal fluid circuit. An example of an ECD is disclosed in U.S. Patent Application Publication No. 2016 / 0193076, entitled "Endocavity Temperature Control Device," published on July 7, 2016, which is hereby incorporated by reference herein.

[0005] When an existing ECD is inserted into the rectum, a volume of air is introduced into the rectal cavity to form bubbles (e.g., air bubbles). The bubbles rise in the rectal cavity and are located between the ECD and the rectal wall near the prostate. In addition, bubbles from intestinal gas naturally exist in the rectal cavity and behave similarly to bubbles formed during ECD insertion. For example, Figure 1 A bubble 100 is shown placed between the cooling surface 112 of the ECD 10 and the rectal wall 120 of the rectum 125 near the prostate 130. For illustration purposes and for clarity, the distance between the cooling surface 112 of the ECD and the rectal wall 120 is shown as being greater than it actually is. In operation, the cooling surface 112 of the ECD is placed close to or adjacent to the rectal wall 120 and the bubble 100 is trapped therebetween. For completeness, Figure 1A heat applicator 140 is shown inserted transurethrally through the upper and lower portions of the prostate 130. These bubbles reduce the effectiveness of the ECD by impeding heat transfer between the ECD and the rectal wall. The bubbles also create acoustic impedance, which can reflect ultrasound energy and affect tissue heating.

[0006] To remove air bubbles 100, ECD 10 may be swept left and right.

[0007] It would be desirable to reduce or eliminate air bubbles in the rectal cavity. Summary of the invention

[0008] The exemplary embodiments described herein have innovative features, none of which is essential or solely responsible for its desired attributes. The following description and accompanying drawings set forth in detail certain illustrative embodiments of the present disclosure, which indicate several exemplary ways in which the various principles of the present disclosure may be implemented. However, the illustrative examples do not exhaust the many possible embodiments of the present disclosure. Without limiting the scope of the claims, some advantageous features will now be summarized. Other objects, advantages, and novel features of the present invention will be set forth in the following detailed description of the present disclosure in conjunction with the accompanying drawings, which are intended to illustrate, but not to limit, the present invention.

[0009] One aspect of the present invention is directed to an endorectal cooling device (ECD) comprising: an elongated body having an insertable portion for insertion into a patient's rectum and an external portion retained outside the rectum, the insertable portion having an external cooling surface; a cooling fluid circuit in the elongated body extending from the external portion to the insertable portion, the cooling fluid circuit circulating a cooling fluid to regulate the temperature of the cooling surface; and a bubble removal device disposed on or confined within the cooling surface.

[0010] In one or more embodiments, the bubble removal device comprises a tube or coil disposed on a cooling surface. In one or more embodiments, the tube or coil is fluidically coupled to a vacuum pump and defines at least one hole in the tube or coil. In one or more embodiments, the at least one hole is aligned with the rectal wall proximate to the prostate. In one or more embodiments, the bubble removal device comprises a coil and the coil is wound in a spiral manner around the insertable portion of the ECD.

[0011] In one or more embodiments, the bubble removal device comprises a tube, and the tube comprises a loop of tubing. In one or more embodiments, the loop of tubing is elongated along an axis parallel to the length of the insertable portion of the ECD. In one or more embodiments, the ECD further comprises a plurality of loops arranged transversely to each other along the cooling surface.

[0012] In one or more embodiments, the bubble removal device includes a mesh structure disposed in a gap in the cooling surface. In one or more embodiments, the mesh structure is fluidly coupled to a vacuum pump via a tube. In one or more embodiments, the bubble removal device includes a plurality of holes defined in the cooling surface, and the holes are fluidly coupled to a low pressure source via a bubble removal channel defined in a housing of the ECD.

[0013] Another aspect of the present invention relates to an endorectal cooling device (ECD) comprising: an elongated body having an insertable portion for insertion into a patient's rectum and an external portion retained outside the rectum, the insertable portion having an external cooling surface; a bubble removal passage defined in the elongated body; a plurality of holes defined in the cooling surface, the holes extending from the cooling surface to the bubble removal passage; a low pressure source fluidly coupled to the holes via the bubble removal passage; and a cooling fluid circuit defined in the elongated body, the cooling fluid circuit being in thermal communication with the cooling surface.

[0014] In one or more embodiments, the low pressure source comprises a venturi structure formed in the proximal end of the elongated body. In one or more embodiments, the low pressure source comprises a vacuum pump.

[0015] In one or more embodiments, the cooling fluid circuit includes a cooling fluid channel extending in a loop from the proximal end of the elongated body to the distal end thereof. In one or more embodiments, a portion of the cooling fluid channel is disposed between the cooling surface and the bubble removal channel. In one or more embodiments, an inner wall defines each hole, the inner wall extending to the bubble removal channel such that the hole is only fluidically coupled to the bubble removal channel. In one or more embodiments, each inner wall forms a tapered portion defining each hole.

[0016] In one or more embodiments, the ECD further comprises an ultrasonic coupling fluid channel defined in the elongated body, the ultrasonic coupling fluid channel extending from the proximal end of the elongated body to the distal end thereof. In one or more embodiments, an outlet of the ultrasonic coupling fluid channel is disposed adjacent to the distal end of the cooling surface. In one or more embodiments, an inlet portion of the cooling fluid channel is located between the ultrasonic coupling fluid circuit and the bubble removal channel. In one or more embodiments, the bubble removal channel is located between an inlet portion of the cooling fluid and an outlet portion of the cooling fluid. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] In order to more fully understand the nature and advantages of the present concept, the following detailed description of the preferred embodiments will be made in conjunction with the accompanying drawings.

[0018] Figure 1 An endorectal cooling device (ECD) according to the prior art is shown.

[0019] Figure 2 An elongated ECD with bubble removal coils is shown in accordance with one or more embodiments.

[0020] Figure 3 An example of an elongated ECD with bubble removal coils according to an alternative embodiment is shown.

[0021] Figure 4 An example of an elongated ECD having a mesh or porous material for removing air bubbles is shown according to an alternative embodiment.

[0022] Figure 5 An example of an elongated ECD having multiple holes for removing air bubbles is shown according to an alternative embodiment.

[0023] Figure 6 Shows Figure 5 A cross section of the ECD is shown in FIG.

[0024] Figure 7 yes Figure 6 The cross section shown in FIG is a detailed view of the distal end of the ECD.

[0025] Figure 8 yes Figure 6 The cross section shown in FIG is a detailed view of the proximal end of the ECD. DETAILED DESCRIPTION

[0026] The bubble removal device is placed on or defined in an external cooling surface of the ECD that is placed proximate to the prostate when the ECD is inserted into the patient's rectum. The bubble removal device includes one or more features for removing bubbles after the ECD is inserted into the patient's rectum.

[0027] In some embodiments, the bubble removal device includes a coil or tube (typically a coil) placed on the external cooling surface of the ECD. The bubble removal coil causes a gap to be formed between the cooling surface of the ECD and the rectal wall near the prostate. In addition, the bubble removal coil can provide an irregular path for bubbles to travel, which is more energetically advantageous than the smooth outer surface of the ECD. In some embodiments, the bubble removal coil can be fluidically coupled to a vacuum pump to remove bubbles. For example, the bubble removal coil can include one or more holes that are aligned with the rectal wall near the prostate. A vacuum can be applied to the bubble removal coil, which causes the fluid including the bubbles to enter the holes and flow to an external fluid reservoir through the coil.

[0028] In another embodiment, the bubble removal device includes a mesh structure disposed on an external cooling surface of the ECD. For example, the mesh structure can form a portion of the external cooling surface of the ECD. Alternatively, the mesh structure can form a portion of the housing of the ECD. The mesh structure is fluidically coupled to a vacuum pump (e.g., via one or more tubes) to remove bubbles. A vacuum can be applied to the mesh structure, which causes the fluid, including the bubbles, to flow through the mesh structure to an external fluid reservoir (e.g., via one or more tubes).

[0029] In another embodiment, the bubble removal device includes a plurality of holes defined in an external cooling surface and / or housing of the ECD. The holes are fluidically coupled to a first end of a bubble removal channel. A low pressure source (e.g., a vacuum pump or a venturi structure) is fluidically coupled to a second end of the bubble removal channel. The low pressure source causes fluid and bubbles to flow through the holes and the bubble removal channel to be collected in an external reservoir.

[0030] In some embodiments, the bubble removal device includes a combination of two or more of the above features. For example, the bubble removal device may include a combination of any one of a coil, a tube, a mesh, and / or holes.

[0031] In some embodiments, ultrasound visible markers may be provided on the ECD that allow the ECD to be visible using ultrasound imaging. In addition, the ECD may include an ultrasound coupling fluid channel for introducing an ultrasound coupling fluid between the ECD and the rectal wall. Additionally or alternatively, the ECD may include a cooling fluid circuit that circulates a cooling fluid in the ECD to cool and / or regulate the temperature of the cooling surface, thereby cooling and / or regulating the temperature of the rectal wall and surrounding anatomical structures.

[0032] Figure 2 An elongated ECD 200 having a bubble removal coil 210 is shown according to one or more embodiments. The bubble removal coil 210 is wound in a spiral manner around an insertable portion 202 of the ECD 200. For example, the bubble removal coil 210 has a central axis that is generally parallel to an axis 203 that defines the length of the insertable portion 202. When the insertable portion 202 is inserted into the rectum 125, the bubble removal coil 210 is disposed between the rectal wall 120 and a cooling surface 212 of the ECD (e.g., on the housing of the ECD 200), in a gap 220 therebetween. The bubble removal coil 210 can provide a surface along which bubbles 100 can travel to escape that is energetically superior to the smooth cooling surface 212 of the ECD 200. The bubble removal coil 210 can include a single tube or multiple tubes. For example, multiple tubes can be disposed adjacent to each other and travel in parallel to form the bubble removal coil 210. Alternatively, multiple tubes may be connected end to end (eg, connected in series) to form the bubble removal coil 210 .

[0033] The coil 210 includes one or more optional holes 205, which are in fluid communication with a vacuum pump 230 or other low pressure source to extract the bubbles 100. In embodiments where the bubble removal coil 210 includes multiple tubes disposed adjacent to each other, one, some or all of the tubes may include holes 205, and such tubes may be in fluid communication with the vacuum pump 230. The holes 205 may be distributed along the length of the coil 210 or they may be disposed only in certain portions of the coil 210. The vacuum pump 230 may be electrically or manually driven. In some embodiments, the vacuum pump 230 is disposed on or in the housing of the ECD 200. A vacuum tube 235 fluidly couples the vacuum pump 230 to the coil 210. The vacuum tube 235 may be disposed on an outer surface of the ECD 200 and / or in a chamber or passage extending through the ECD 200.

[0034] The cooling fluid circuit 240 circulates a cooling fluid through the ECD 200. The cooling fluid circuit 240 includes a cooling fluid reservoir 250 and a pump 260 for circulating the cooling fluid through the cooling fluid circuit 240. The cooling fluid circuit 240 may extend from the proximal end 204 of the ECD 200 (including through the insertable portion 202) to the distal end 206 thereof. The cooling fluid circuit 240 may flow proximally to the cooling surface 212 such that the cooling fluid is in thermal communication with the cooling surface 212 to reduce and / or regulate the temperature thereof, and thereby reduce and / or regulate the temperature of the rectal wall 120 and nearby patient anatomy.

[0035] ECD 200 also includes optional ultrasonically visible markers 270. Ultrasonically visible markers 270 have a higher acoustic impedance than the housing of ECD 200, which allows them to be visible using ultrasound. For example, ultrasonically visible markers 270 may include titanium or another material with high acoustic impedance.

[0036] Figure 3 An example of an elongated ECD 300 with a bubble removal tube 310 according to an alternative embodiment is shown. The tube 310 is partially or entirely disposed on the outer surface of the insertable portion 302 of the ECD 300. The tube 310 includes an elongated loop extending along at least a portion of the length of the ECD 300. For example, the tube 310 may be formed into a rectangular or oval shape elongated along an axis 315 parallel to the axis 203. In some embodiments, the tube 310 may include two or more loops. For example, the first loop may be disposed in the second loop (that is, the first loop is wider than the second loop (e.g., along an axis orthogonal to the axis 315) so that the first loop is assembled in the second loop). Alternatively, the first loop and the second loop may be disposed adjacent to each other or laterally along the cooling surface 312 of the ECD 300. In another embodiment, a plurality of loops may be disposed in a configuration such as end-to-end or an overlapping configuration along the elongated length of the ECD 300 (e.g., along the cooling surface 312).

[0037] When the ECD 300 is inserted into the rectum 125, at least some of the tubes 310 are disposed between the rectal wall 120 and the cooling surface 112 of the ECD (e.g., on the housing of the ECD 110), in the gap 320 therebetween. The tubes 310 may provide a surface along which the gas bubbles 100 may travel to escape that is energetically superior to the smooth cooling surface 312 of the ECD 300.

[0038] One or more loops in the tube 310 may include one or more holes 305 that are in fluid communication with the vacuum pump 230 to extract the gas bubbles 100, such as described above with respect to the coil 210. The ECD 300 may include ultrasonically visible markings such as the ultrasonically visible markings 270. Additionally or alternatively, the ECD 300 may include a cooling fluid circuit such as the cooling fluid circuit 240, which is not shown in the figure for clarity purposes. Figure 3 Not shown in the figure.

[0039] Figure 4 An example of an elongated ECD 400 having a mesh or porous material 410 for removing bubbles is shown according to an alternative embodiment. The mesh or porous material 410 is disposed in a gap 411 of a cooling surface 412 in the insertable portion 402 of the ECD 400 so that when the ECD 400 is inserted into the rectum 125, the mesh or porous material 410 faces the rectal wall 120. The mesh or porous material 400 provides a surface along which bubbles 100 can travel to escape that is energetically superior to the smooth cooling surface 412 of the ECD 400. In addition, when a vacuum is applied by the vacuum pump 230, the bubbles 100 can flow through the mesh or porous material 410 into an internal or external channel 420. In some embodiments, the channel 410 is an internal channel that can be fluidically coupled to other channels in the ECD 400 (e.g., via a manifold), such as for circulating a cooling fluid. In some embodiments, the mesh or porous material 410 comprises a woven plastic sheet or a woven fabric.

[0040] ECD 400 may include ultrasonically visible markings such as ultrasonically visible markings 270. Additionally or in the alternative, ECD 400 may include a cooling fluid circuit such as cooling fluid circuit 240, which is not shown in FIG. Figure 4 The cooling fluid circuit is not shown in FIG.

[0041] Figure 5An example of an elongated ECD 500 having a plurality of holes 510 for removing bubbles according to an alternative embodiment is shown. The holes 510 are defined in a housing 511 on an insertable portion 502 of the ECD 500, such as in a cooling surface 512 and / or other portions of the elongated body. The holes 510 may be arranged in a regular or irregular arrangement. For example, the holes 510 may be arranged in an array, pattern or other regular arrangement. Alternatively, the holes 510 may be irregularly arranged in the housing 511. Regardless of the arrangement, the holes 510 may have the same size and / or different sizes. For example, the holes may have (a) the same and / or different widths (e.g., diameters) and / or (b) the same and / or different cross-sectional profiles. In some embodiments, the holes 510 may be formed by 3D printing.

[0042] The aperture 510 is fluidly coupled to the low pressure source such that fluid in the rectum 125 and any air bubbles 100 therein are drawn through the aperture 510 into one or more passages extending between the aperture 510 and the low pressure source.

[0043] Figure 6 It passes through Figure 5 A cross section of ECD 500 taken along plane 6-6 in FIG. Figure 6 As shown, the ECD 500 includes a plurality of channels defined in the housing 511. For example, the ultrasound coupling fluid channel 520 is the first channel defined in the housing 511 and extends from the proximal end 504 of the ECD 500 to the distal end 506 thereof. The proximal end 504 of the ultrasound coupling fluid channel 520 is fluidically coupled to an ultrasound coupling fluid reservoir 525, which may include a pump that causes the ultrasound coupling fluid to flow from the proximal end 504 of the ECD 500 through the ultrasound coupling fluid channel 520 to the distal end 506 of the ECD 500. Additionally or alternatively, the ultrasound coupling fluid reservoir 525 may be disposed higher than the ECD 500 to gravity feed the ultrasound coupling fluid into the ultrasound coupling fluid channel 520. The ultrasound coupling fluid may include a biocompatible liquid (e.g., a saline solution) having approximately the same acoustic impedance as the body fluid in the rectum 125, for example, to minimize acoustic reflections or scattering.

[0044] At or near the distal end 506, the ultrasound coupling fluid channel 520 has a U-shaped bend 522 such that an outlet 524 of the ultrasound coupling fluid channel 520 is adjacent to the distal end 706 of the cooling surface 512. The outlet 524 is preferably configured such that the ultrasound coupling fluid flows generally parallel to or toward the cooling surface 512 such that at least some of the ultrasound coupling fluid contacts the cooling surface 512 and / or other surfaces of the ECD 500 to improve ultrasound imaging and thermal coupling of tissue to the ECD 500. In other embodiments, the ultrasound coupling fluid channel 520 may be configured such that the ultrasound coupling fluid is directed away from the cooling surface 512. For example, the outlet 524 may be configured such that the ultrasound coupling fluid is directed toward the rectal wall 120 and away from the cooling surface 512. In some embodiments, the flow or "current" of the ultrasound coupling fluid may cause bubbles to move toward the aperture 510 or away from the cooling surface 512, which may be an advantage of the ECD 500 configuration. In other embodiments, the ultrasound coupling fluid channel 520 can include a first outlet that directs the ultrasound coupling fluid parallel to the cooling surface 512 and a second outlet that directs the ultrasound coupling fluid away from the cooling surface 512. The ultrasound coupling fluid provides an acoustic coupling medium to transmit ultrasound energy to and / or from the ECD 500, such as during ultrasound imaging, to position the cooling surface 512 of the ECD 500 relative to the rectal wall 120.

[0045] The cooling fluid channel 530 is a second channel defined in the housing 511 and extends in a loop from the proximal end 504 of the ECD 500 to the distal end 506 of the ECD 500. At the proximal end 504, the cooling fluid channel 530 is fluidly coupled to a cooling fluid reservoir 535, which may include a pump that causes the cooling fluid to flow from the proximal end 504 of the ECD 500 through the cooling fluid channel 530 to the distal end 506 of the ECD 500. Additionally or alternatively, the cooling fluid reservoir 535 may be positioned higher than the ECD 500 to gravity feed the cooling fluid into the cooling fluid channel 530. The cooling fluid may include a biocompatible liquid (e.g., a saline solution) that may transfer thermal energy to and / or from the cooling surface 512.

[0046] At or near the distal end 506, the cooling fluid channel 530 has a U-shaped bend 532 that redirects the cooling fluid toward the proximal end 504 of the ECD 500. After the U-shaped bend 532, the cooling fluid channel 530 is disposed adjacent to the cooling surface 512 so that thermal energy can be transferred between the cooling surface 512 and the cooling fluid. At the proximal end 504, the cooling fluid channel 530 includes an optional venturi structure 540 that can cause a pressure reduction that can act as a vacuum pump to draw the entrained ultrasound coupling fluid and / or air bubbles out of the interface between the rectal wall and the ECD and into the cooling fluid channel 530. The cooling fluid exiting the cooling fluid channel 530 can flow into a cooling fluid reservoir 535 to be recirculated back through the cooling fluid channel 530. In some embodiments, the ultrasound coupling fluid and the vacuum generating device are coupled to separate fluid circuits. In some embodiments, a heat exchanger may be provided between the venturi structure 540 and the cooling fluid reservoir 535 to reduce the temperature of the cooling fluid. In alternative embodiments, the venturi structure 540 may be replaced with a vacuum pump, which may be provided internally or externally with respect to the ECD 500.

[0047] In some embodiments, when the ultrasonic coupling fluid and the cooling fluid comprise the same or compatible type of fluid (e.g., saline), the ultrasonic coupling fluid channel 520 and the cooling fluid channel 530 may be combined at the proximal end 504 of the ECD 500 such that the ultrasonic coupling fluid channel 520 and the cooling fluid channel 530 have a single inlet. The single inlet may be fluidly coupled to a single fluid reservoir, which may be the same as the ultrasonic coupling fluid reservoir 525 or the cooling fluid reservoir 535. An inner wall separating the ultrasonic coupling fluid channel 520 and the cooling fluid channel 530 may be disposed between the proximal end 504 of the ECD 500 and the distal end 506 thereof. Alternatively, the inner wall may be disposed at or after the U-shaped bend.

[0048] The bubble removal channel 550 is a third channel defined in the housing 511 and extends from the proximal end 504 of the ECD 500 to the distal end 506 thereof. The bubble removal channel 550 is disposed between the inlet portion 531 of the cooling fluid channel 530 and the outlet portion 533 thereof. The bubble removal channel 550 is in fluid communication with the fluid and the bubbles 100 disposed between the cooling surface 512 and the rectal wall 120 via the aperture 510 extending from the cooling surface 512 to the bubble removal channel 550. Near the proximal end 504, the bubble removal channel 550 merges with the cooling fluid channel 530. The low pressure caused by the venturi structure 540 causes the fluid and the bubbles 100 to flow through the aperture 510 and out through the bubble removal channel 550.

[0049] Figure 7 yes Figure 6 The cross section shown is a detailed view at the distal end 506 of the ECD 500. Representative arrows indicate the direction of fluid flow in the ultrasonic coupling fluid channel 520, the cooling fluid channel 530, and the bubble removal channel 550. In addition, Figure 7 The aperture 510 is shown to be defined by an inner wall 705 that forms an optional cone 710 with a tube 712 that extends from the cone opening 714 through the outlet portion 533 of the cooling fluid channel 530 to the bubble removal channel 550. The inner wall 705 fluidly couples the aperture 510 to the bubble removal channel 550, but not to the cooling fluid channel 530. In other embodiments, some or all of the apertures 510 may be formed by a tube (e.g., tube 712) without a tapered opening 714. Additionally or alternatively, the tapered opening 714 may have a rectangular or square cross-section instead of a circular cross-section. Additionally or in the alternative, the tube 712 may have a rectangular or square cross-section instead of a circular cross-section.

[0050] Figure 8 yes Figure 6 The cross section shown is a detailed view at the proximal end 504 of the ECD 500. Representative arrows indicate the direction of fluid flow in the ultrasound coupling fluid channel 520, the cooling fluid channel 530, and the bubble removal channel 550. In addition, Figure 8 The venturi structure 540 is shown to include an inlet cone 542 having a tapered cross-sectional width for fluid flow, a generally cylindrical throat or neck 544 having a narrower cross-sectional width for fluid flow, and an outlet cone 546 having a diverging cross-sectional width for fluid flow.

[0051] In some embodiments, ECD 200 , 300 , and / or 400 may include an internal channel for introducing an ultrasound coupling fluid (eg, ultrasound coupling fluid channel 520 ) between each ECD and rectal wall 120 .

[0052] The present invention should not be considered limited to the specific embodiments described above, but should be understood to cover all aspects of the technology as fairly described herein. Once those skilled in the art to which the present invention relates read the present disclosure, they will understand various modifications, equivalent processes and many structures to which the present invention is applicable.

Claims

1. An intrarectal cooling device comprising: an elongated body having an insertable portion for insertion into a patient's rectum and an exterior portion retained outside of the rectum, the insertable portion having an exterior cooling surface; a bubble removal passage defined in the elongated body; a plurality of holes defined in the cooling surface, the holes extending from the cooling surface to the bubble removal passage; a low pressure source fluidly coupled to the aperture via the bubble removal passage; as well as A cooling fluid circuit is defined in the elongated body, the cooling fluid circuit being in thermal communication with the cooling surface.

2. The intrarectal cooling device of claim 1, wherein: The low pressure source includes a venturi structure formed in the proximal end of the elongated body.

3. The intrarectal cooling device of claim 1, wherein: The low pressure source includes a vacuum pump.

4. The intrarectal cooling device of claim 1, wherein: The cooling fluid circuit includes a cooling fluid channel extending in a loop from a proximal end of the elongated body to a distal end of the elongated body.

5. The intrarectal cooling device of claim 4, wherein: A portion of the cooling fluid passage is provided between the cooling surface and the bubble removal passage.

6. The intrarectal cooling device of claim 5, wherein: An inner wall defines each aperture, the inner wall extending to the bubble removal channel such that the aperture is fluidly coupled only to the bubble removal channel.

7. The intrarectal cooling device of claim 6, wherein: Each inner wall forms a tapered portion defining each hole.

8. The intrarectal cooling device of claim 4, wherein: The intrarectal cooling device also includes an ultrasound coupling fluid channel defined in the elongated body, the ultrasound coupling fluid channel extending from a proximal end of the elongated body to a distal end of the elongated body.

9. The intrarectal cooling device of claim 8, wherein: An outlet of the ultrasound coupling fluid channel is disposed near a distal end of the cooling surface.

10. The intrarectal cooling device of claim 8, wherein: An inlet portion of the cooling fluid channel is located between the ultrasound coupling fluid circuit and the bubble removal channel.

11. The intrarectal cooling device of claim 9, wherein: The bubble removal passage is located between an inlet portion of the cooling fluid and an outlet portion of the cooling fluid.

12. An intrarectal cooling device comprising: an elongated body having an insertable portion for insertion into a patient's rectum and an exterior portion retained outside of the rectum, the insertable portion having an exterior cooling surface; a cooling fluid circuit in the elongated body, the cooling fluid circuit extending from the outer portion to the insertable portion, the cooling fluid circuit circulating a cooling fluid to regulate a temperature of the cooling surface; as well as a bubble removal device disposed on or defined in the cooling surface, Therein, the bubble removal device includes a tube forming an elongated loop, the tube is disposed only on an outer surface of the insertable portion, the tube is fluidically coupled to a vacuum pump, and at least one hole is defined in the tube.

13. The intrarectal cooling device of claim 12, wherein: The elongated loop is elongated along an axis parallel to the length of the insertable portion of the intrarectal cooling device.

14. The intrarectal cooling device of claim 13, wherein: The intrarectal cooling device further comprises a plurality of the elongated loops arranged transversely to each other along the cooling surface.

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