Devices and methods for fluid distribution from catheter

Abstract

To provide a device and a method of carrying fluid delivered from a delivery catheter.SOLUTION: A device comprises a body which has a proximal end, a distal end, and a wall with the width extending between the proximal and distal ends along a longitudinal axis of the body, the body defining a cavity portion and an instrument lumen, the cavity portion extending within the body from the proximal end to the distal end, the instrument lumen extending through the body and being parallel to the longitudinal axis from an opening at the proximal end of the body to an opening at the distal end of the body, the instrument lumen configured to receive an instrument extending through the instrument lumen, an inlet at the proximal end of the body extending into the cavity portion and in fluid communication with the cavity portion, the inlet including an inlet port configured to receive the distal end of a delivery catheter, and one or more apertures along the wall of the body being in fluid communication with the cavity portion and configured to allow fluid delivered from the catheter through the inlet port into the cavity portion to flow out.SELECTED DRAWING: None

Description

[Technical field]

[0001] Priority This application claims the benefit of priority under 35 U.S.C. §119 to U.S. Provisional Patent Application No. 62 / 633,121, filed February 21, 2018, which is incorporated by reference in its entirety for all purposes.

[0002] The present disclosure relates generally to the field of medical devices. In particular, the present disclosure relates to an apparatus and method for conveying fluids delivered from a delivery catheter. Exemplary catheters are disclosed that include fluid distribution devices for delivering fluids within body lumens as well as for delivering pass-through medical instruments such as cryodecompression tubes. [Background technology]

[0003] Various catheters are used in body lumens for a variety of applications, including delivering fluids to the body lumen as diagnostic or therapeutic options. The fluid can be a liquid, a gas, or a mixture of both liquid and gas. Delivery may require spraying the fluid onto the walls of the body lumen. In some cases, the effectiveness and / or efficiency of the treatment may depend on how unobstructed the delivered fluid is from the catheter and / or spraying device by the walls of the body lumen.

[0004] As an example, cryosurgery is a procedure in which diseased, damaged, or otherwise undesirable tissue (collectively referred to herein as "target tissue") is treated by delivery of a cryogen under pressure, which may be a cryogen spray. These systems are commonly referred to as cryoablation systems, cryospray systems, cryospray ablation systems, cryosurgery systems, cryosurgery spray systems, and / or cryogen spray ablation systems. As commonly used, "cryogen" refers to any fluid (e.g., a gas, liquefied gas, or other fluid known to those skilled in the art) with a boiling point sufficiently low (i.e., less than about -153°C) for therapeutic use during cryogenic surgical procedures. Suitable cryogens may include, for example, argon, nitrogen, and helium. Cryogens with boiling points above -153°C but still very low compared to atmospheric and body temperature (e.g., N 2 -88.5 °C for O and -88.5 °C for CO 2 Cryogenic simulants such as carbon dioxide or nitrous oxide, which have a temperature of -78.5°C for 100°F, may be used.

[0005] During operation of the cryospray system, a medical professional (e.g., clinician, technician, medical professional, surgeon, etc.) can direct the cryospray through the cryodelivery catheter onto the surface of the treatment area. The medical professional can visually target the cryospray through a video-assisted device or endoscope, such as a bronchoscope, gastroscope, colonoscope, ureteroscope, pediatric scope, etc. The cryospray can exit the cryodelivery catheter at a temperature ranging from 0°C to -196°C to freeze the target tissue.

[0006] Intracorporeal treatment of a treatment site may include catheters in various shapes, for various uses, and across a range of treatment sites, along with other instruments necessary for the treatment. For example, during spray cryotherapy, a cryo-decompression tube (CDT), gas removal tube (GRT), or gas release tube (GET) must be placed in the stomach before treating the esophagus to vent the cryogen gases produced during treatment. The tubes can usually be placed away from the treatment device relative to the surface of the body lumen, which may result in untreated areas behind the tube relative to the spray device (i.e., the tube blocks the cryogen spray from reaching the tissue at the treatment site). If the tube hides the cryogen spray during treatment, adjacent tissue may be prevented from freezing completely. The clinician must remove and redirect the tube and / or cryogen delivery device / catheter at another location to treat the untreated area or return for a second treatment. Such tubes or other instruments may be placed over a guidewire, but the guidewire represents an additional potential obstacle in the working channel of the endoscope or at the treatment site, or both.

[0007] It is with respect to these considerations that the apparatus, systems, and methods of the present disclosure may be useful. Summary of the Invention [Means for solving the problem]

[0008] The present disclosure, in various embodiments thereof, includes devices, systems, and methods for dispensing fluids, such as cryosprays, that can be used in conjunction with other medical instruments to more efficiently deliver and distribute the fluid to a treatment area. Such devices and methods can provide, among other advantages, more efficient coverage of treatment fluids, such as cryosprays, at the treatment site. Various embodiments allow the instrument to extend through a lumen of an instrument that also has a hollow portion for fluid delivery, allowing the fluid and / or spray to be unconstrained by the instrument at the treatment site.

[0009] In various embodiments, the device can include a body having a proximal end, a distal end, and a wall having a width extending therebetween along a longitudinal axis of the body. The body can define a cavity portion and an instrument lumen. An inlet can be at the proximal end of the body. The inlet can extend into the cavity portion and be in fluid communication with the cavity portion. The inlet can be configured to receive a distal end of a delivery catheter. The instrument lumen can extend through the body and can be parallel to the longitudinal axis from an opening at the proximal end of the body to an opening at the distal end of the body. The instrument lumen can be configured to receive an instrument extending through the instrument lumen. One or more holes can be in fluid communication with the cavity portion along the wall of the body, such that fluid delivered from the catheter can flow into the cavity portion through the inlet and out of the cavity portion through the one or more holes.

[0010] In various embodiments described herein and elsewhere, the inlet can include an elongated surface that extends at least partially into the cavity portion. The elongated surface can include a step-down portion within the cavity portion. The step-down portion can have a diameter that is smaller than a diameter of the remainder of the elongated surface. The one or more holes can include spray holes. The cavity portion can be an annulus. The cavity portion can extend around the instrument lumen and can be closed to the instrument lumen. The cavity portion can be open to the inlet to channel fluid delivered from the delivery catheter from the inlet into the cavity portion and out of the cavity portion through the one or more holes. The body can have a pear-shaped cross-section. The inlet can be parallel to the instrument lumen. The catheter can be removably attachable to the body. The catheter can be permanently attached to the body. The instrument lumen can be substantially perpendicular to the one or more holes. The body can have a rounded tip at a distal end. There can be multiple flow channels within the cavity portion. The flow channel may be configured to distribute flow from the inlet through the hollow portion and out of the one or more holes. The one or more holes may include a straight lumen extending through the wall of the body. The one or more holes may include a frusto-conical shape spanning the width of the wall of the body. The diameter of the holes that may be on the inner surface of the wall may be larger than the diameter of the holes that may be on the outer surface of the wall. The one or more holes may span the width of the wall at an angle perpendicular to the wall. The one or more holes may span the width of the wall at an angle relative to the wall. The angle may be from about 15 degrees to about 165 degrees. Some of the one or more holes may span the width of the wall at an angle that is not perpendicular to the wall. Some of the other one or more holes may span the width of the wall at an angle that is perpendicular to the wall. The one or more holes may generate a spray pattern of fluid delivered from the holes around the entire circumference of the body.

[0011] In various embodiments, the system can include a delivery catheter that can have a proximal end, a distal end, and a delivery lumen therebetween. A fluid distribution device can be coupled to the distal end of the catheter. The fluid distribution device can include a body that can have a proximal end, a distal end, and a wall with a width extending therebetween along a longitudinal axis of the body. An inlet can be at the proximal end of the body. The inlet can be configured to couple to the distal end of the delivery catheter. A plurality of raised elements can be disposed on the wall. Each portion of the raised elements can extend radially outward from the longitudinal axis. A plurality of channel holes can be disposed on the wall between adjacent raised elements of the plurality of raised elements. A plurality of channels can be in fluid communication with the inlet, each extending to a respective one or more of the plurality of channel holes. An instrument lumen can extend through the body substantially parallel to the longitudinal axis from a proximal opening at the proximal end of the body to a distal opening at the distal end of the body. The instrument lumen can be configured to receive a medical instrument passing therethrough. An elongate tubular member may be disposed about the body. A plurality of spray holes may be disposed about the elongate tubular member. The spray holes may be disposed between the raised elements. A medical instrument may be disposed through the instrument lumen.

[0012] In various embodiments described herein and elsewhere, the system may include an expandable member disposed about the body of the fluid dispensing device. The expandable member may have a proximal end that is fixed in place relative to the delivery catheter. The expandable member may have a distal end that is fixed in place relative to the medical device. A coating may extend partially from the distal end of the expandable member toward the proximal end of the expandable member. The coating may be configured to substantially prevent fluid from proceeding distally. An extension tube may be fixed in place relative to the distal end of the expandable member and may extend distally from the distal end. The distal end of the expandable member may be fixed in place by an adhesive, a molded thermoplastic sleeve, cuff, or collar, or by chemical bonding. The adhesive at the distal end of the expandable member may substantially prevent fluid from proceeding distally past the adhesive. The inlet may extend parallel to the device lumen. The medical device may be one of an endoscope, a guidewire, or a cryo-vacuum tube, or a combination thereof. A detent may be in the inlet and may be configured to mate with a protrusion on the catheter to lock the catheter in place relative to the inlet. The plurality of raised elements may be ribs extending circumferentially about the longitudinal axis. The body may be permanently attached to the catheter. The spray hole may be a substantially straight lumen through the elongated tubular member. The plurality of spray holes may include a frusto-conical shape spanning the width of the wall of the elongated tubular member. The diameter of the hole on the inner surface of the wall may be greater than the diameter on the outside of the wall. The one or more holes may span the width of the wall of the elongated tubular member at an angle perpendicular to the longitudinal axis. The one or more holes may span the width of the wall of the elongated tubular member at an angle relative to the longitudinal axis. The angle may be between about 15 degrees and about 165 degrees. Some of the one or more holes may span the width of the wall of the elongated tubular member at an angle that is not perpendicular to the longitudinal axis. Others of the one or more holes may span the width of the wall at an angle perpendicular to the longitudinal axis.

[0013] In various embodiments, the device can include a housing having a proximal end and a distal end and extending along a longitudinal axis. An instrument lumen can extend through the housing parallel to the longitudinal axis from the proximal end to the distal end of the housing. The housing can have a cavity portion defined therein and extending circumferentially around the instrument lumen. An inlet can extend from the proximal end of the housing into the cavity portion. The inlet can be in fluid communication with the cavity portion and can be configured to receive a distal end of a cryogen fluid delivery catheter. One or more holes in the housing can be in fluid communication with the cavity portion and can be configured to distribute cryogen fluid from the catheter and the cavity portion to an exterior of the housing.

[0014] In various embodiments described herein and elsewhere, the one or more holes may be oriented perpendicular to the longitudinal axis. The inlet may have a diameter configured to interact with the catheter such that the catheter and the inlet may substantially contact one another when coupled together. Multiple flow channels may be within the hollow portion and may be configured to evenly distribute the flow of cryogen fluid from the catheter from the inlet through the hollow portion and out of the one or more holes. Detents on the inlet may be configured to mate with protrusions on the catheter to lock the catheter in place relative to the inlet.

[0015] In various embodiments, the device can include a body having a proximal end, a distal end, and a wall having a width extending therebetween along a longitudinal axis of the body. The body can define a cavity portion. An inlet can extend through the proximal end of the body. The inlet can extend into the cavity portion and be in fluid communication with the cavity portion. The inlet can be configured to receive a distal end of a delivery catheter. A lumen can extend through the body parallel to the longitudinal axis from an opening at the proximal end of the body to an opening at the distal end of the body. An internal wall can be within the body and around the lumen defining an insulating annulus between the lumen and the cavity portion. One or more holes can be disposed around and extend through the width of the wall of the body in fluid communication with the cavity portion, whereby fluid delivered from the catheter can flow into the cavity portion through the inlet and out of the cavity portion through the one or more holes. The insulating annulus can be a substantially sealed vacuum chamber or a low conductivity fill medium suitable for use within the cryogenic temperature range. A transition zone can be between the inlet and the cavity portion and in fluid communication with the inlet and the cavity portion. The transition zone can increase in volume in a distal direction. The transition zone can include one or more interior walls that can be configured to distribute a flow of fluid received from the inlet through the cavity portion toward the one or more holes. The distal end of the lumen can include an annular barb that can extend distally from the lumen and can be configured to interact with a tubular member in fluid communication with the lumen. The lumen can extend distally past the body. The body can include a laser cut hypotube. The cavity portion can extend around the instrument lumen and can be closed relative to the instrument lumen. The cavity portion can be open to the inlet to channel fluid delivered from the delivery catheter through the inlet, into the cavity portion, and out of the cavity portion through one or more holes.

[0016] In various embodiments, the device can include a body having a proximal end, a distal end, and a wall having a width extending therebetween along a longitudinal axis of the body. The inlet can be at the proximal end of the body. The inlet can be configured to couple to a distal end of a delivery catheter. A plurality of raised elements can be disposed on the wall. Each portion of the raised elements can extend radially outward from the longitudinal axis. Each of the plurality of channel holes may be disposed on a wall between adjacent raised elements of the plurality of raised elements. The plurality of channels may be in fluid communication with the inlet, each extending to a respective one or more of the plurality of channel holes. A lumen may extend through the body in a direction substantially along the longitudinal axis from a proximal opening at a proximal end of the body to a distal opening at a distal end of the body. The lumen may be configured to receive a medical instrument passing therethrough. An elongated tubular member may be disposed about the body. A plurality of spray holes may be disposed about the elongated tubular member. The spray holes may be disposed between the raised elements.

[0017] In various embodiments described herein and elsewhere, the plurality of raised elements may be in substantial contact with the elongate tubular member.

[0018] Non-limiting embodiments of the present disclosure are described by way of example with reference to the accompanying drawings, which are schematic and not drawn to scale. In the accompanying drawings, each identical or nearly identical component shown is typically represented by a single numeral. For clarity, not every component is labeled in every drawing, nor is every component of each embodiment shown where illustration is not necessary to enable those skilled in the art to understand the disclosure. [Brief description of the drawings]

[0019] [Figure 1] FIG. 1 illustrates a fluid distribution system within a body lumen according to one embodiment of the present disclosure. [Figure 2A] 1 is a cross-sectional front view of a fluid dispensing apparatus according to one embodiment of the present disclosure. [Figure 2B] FIG. 2B shows a front cross-sectional view of the device of FIG. 2A as a system with catheters and instruments included according to one embodiment of the present disclosure. [Figure 2C] FIG. 2C is a top view of the device of FIGS. 2A and 2B. [Diagram 3] FIG. 1 is a perspective view of a fluid distribution system according to one embodiment of the present disclosure. [Figure 4A] 1 is a perspective view of a fluid dispensing apparatus according to one embodiment of the present disclosure. [Figure 4B] 1 is a left cross-sectional view of a fluid dispensing apparatus according to one embodiment of the present disclosure. [Diagram 5] 1 is a perspective partial cross-sectional view of a fluid distribution system according to one embodiment of the present disclosure. [Figure 6] FIG. 1 is a perspective view of a fluid distribution system according to one embodiment of the present disclosure. [Figure 7A] FIG. 1 illustrates a fluid distribution system according to one embodiment of the present disclosure. [Figure 7B] FIG. 2 illustrates another diagram of a fluid distribution system according to an embodiment of the present disclosure. [Figure 7C] FIG. 2 illustrates another diagram of a fluid distribution system according to an embodiment of the present disclosure. [Figure 7D] FIG. 2 illustrates another diagram of a fluid distribution system according to an embodiment of the present disclosure. [Figure 7E] FIG. 2 illustrates another diagram of a fluid distribution system according to an embodiment of the present disclosure. [Figure 7F] FIG. 2 illustrates another diagram of a fluid distribution system according to an embodiment of the present disclosure. [Figure 7G] FIG. 2 illustrates another diagram of a fluid distribution system according to an embodiment of the present disclosure. [Figure 8A] 1 is a partial cross-sectional view of a fluid dispensing apparatus according to one embodiment of the present disclosure. [Figure 8B] 2 is another partial cross-sectional view of a fluid dispensing apparatus according to one embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0020] The present disclosure is not limited to the described embodiments. The terms used herein are only for the purpose of describing specific embodiments and are not limiting. Unless otherwise defined, all technical terms used herein have the same meaning as commonly understood by those skilled in the art to which the present disclosure belongs.

[0021] Although embodiments of the present disclosure may be described with particular reference to cryogen fluid distribution from an esophageal or bronchial catheter using a cryo-vacuum tube (CDT), such devices, systems, and methods may be used with a variety of fluids, with a variety of instruments, and in a variety of other body passages, organs, and / or cavities, such as the vascular system, the genitourinary system, the upper gastrointestinal system, the lower gastrointestinal system, etc.

[0022] As used herein, the singular forms "a," "an," and "the" are intended to include the plural forms unless the context clearly dictates otherwise. It will be further understood that the terms "comprises" and / or "comprising" or "includes" and / or "including," as used herein, specify the presence of stated parts, regions, step elements, and / or components, but do not exclude the presence or addition of one or more other parts, regions, integers, steps, operations, elements, components, and / or groups thereof.

[0023] As used herein, the conjunction "and" includes each of the structures, components, parts, etc. so coordinated, unless the context clearly dictates otherwise, and the conjunction "or" includes one or the other of the structures, components, parts, etc. so coordinated, in any combination and number, alone, unless the context clearly dictates otherwise.

[0024] As used herein, the term "distal" refers to the end along a system or device that is furthest from the medical professional when the system or device is being introduced into a patient, whereas the term "proximal" refers to the end along a system or device that is closest to the medical professional when the system or device is being introduced into a patient.

[0025] The devices and methods of the present disclosure may be used in conjunction with cryoablation systems to distribute a flow of cryospray gas (hereinafter referred to as "cryoagent" or "cryospray") within a body lumen. Exemplary cryoablation systems with which the present disclosure may be practiced include, but are not limited to, those systems described in commonly owned U.S. Patent Nos. 9,820,797, 9,301,796, and 9,144,449, and U.S. Patent Application Nos. 11 / 956,890, 14 / 012,320, and 14 / 869,814, each of which is incorporated herein by reference in its entirety. In various embodiments, fluid dispensing features and advantages can be realized throughout this disclosure, as well as throughout the disclosure of commonly owned U.S. provisional patent application entitled "Systems and Methods to Enhance Radial Spray from a Catheter" to Downey et al., filed concurrently herewith (Attorney Docket No. 8177.0038), the entire contents of which are incorporated herein by reference for all purposes.

[0026] All numerical values ​​herein are intended to be modified by the term "about", whether or not expressly indicated. The term "about", in the context of numerical values, generally refers to a range of numerical values ​​that one of ordinary skill in the art would consider equivalent to the recited value (i.e., having the same function or result). In many cases, the term "about" may include numerical values ​​that have been rounded to the nearest significant figure. Other uses of the term "about" (i.e., in contexts other than numerical values) may be deemed to have the ordinary and customary definition of its usage that is understood from and consistent with the context of this specification, unless otherwise indicated.

[0027] The recitation of numerical ranges by endpoints includes all numbers within that range, inclusive of the endpoints (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0028] It should be noted that references herein to "embodiments," "some embodiments," "other embodiments," and the like, indicate that the described embodiment may include a particular feature, structure, or characteristic, but not all embodiments may necessarily include the particular feature, structure, or characteristic. Moreover, such phrases do not necessarily refer to the same embodiment. Moreover, if a particular feature, structure, or characteristic is described in relation to an embodiment, it should be within the knowledge of one of ordinary skill in the art to affect such feature, structure, or characteristic in relation to other embodiments, unless expressly specified otherwise, whether or not explicitly described. That is, it is contemplated that various individual elements described below, even if not explicitly shown in a particular combination, can be combined or arranged with one another to form other additional embodiments or to complement and / or enhance the described embodiments, as would be understood by one of ordinary skill in the art.

[0029] Various embodiments of the present disclosure allow various endoscopic instruments (e.g., CDT, biopsy device, stent sizer, stent delivery system, etc.) to be received and extended through the instrument lumen of the fluid distribution device while the distal end of the delivery catheter is received through the inlet of the device. Once the instrument, device, and catheter are advanced to a desired location within the body lumen, a fluid such as cryogen can be delivered through the catheter into the inlet of the device and out of the one or more holes. Fluid sprayed from the one or more holes can reach the target tissue of the patient unimpeded by the endoscopic instrument extending through the instrument lumen.

[0030] Referring to FIG. 1, one embodiment of a fluid distribution system according to the present disclosure is shown including a delivery catheter 130 having a proximal end, a distal end, and a lumen therebetween. A fluid distribution device 100 is coupled to the distal end of the catheter 130. The device 100 has a body 102 having a proximal end, a distal end, and a wall having a width extending therebetween along a longitudinal axis of the body 102. The body 102 defines a cavity portion and an instrument lumen 108. The instrument lumen 108 extends through the body 102. The device 100 has an inlet 104 at a proximal end of the body 102. The inlet 104 extends into the cavity portion and is in fluid communication with the cavity portion. The inlet 104 receives the distal end of the delivery catheter 130. The device 100 includes holes 110 along the wall of the body 102 that are in fluid communication with the cavity portion, such that fluid delivered from the catheter 130 flows into the cavity portion through the inlet 104 and out of the cavity portion through the holes 110, distributing the fluid from the catheter 130 and the cavity portion to the exterior of the body 102. An instrument 132, such as a CDT, is received within and extends through the instrument lumen 108. An endoscope 134, such as a pediatric scope, external to the system, may be used to view and position the device 100, catheter 130, and instrument 132. The system is shown inserted within a body lumen 136, with the device 100 positioned so that the system can treat a target tissue 138.

[0031] 2A-2C, one embodiment of a fluid dispensing device 200 according to the present disclosure is shown including a body 202 having a proximal end 202p, a distal end 202d, and a wall 202w having a width extending therebetween that extends along a longitudinal axis L of the body 202. The body 202 defines a cavity portion 206 and an instrument lumen 208. There is an inlet 204 through the body proximal end 202p. The inlet 204 extends into and is in fluid communication with the cavity portion 206. The inlet 204 is configured to receive a distal end of a delivery catheter 230. The inlet 204 includes an elongated surface 203 that extends at least partially into the cavity portion 206. The elongated surface 203 has a step-down portion 205 within the cavity portion 206, making the diameter of the opening at the distal end of the inlet smaller than the diameter of the remainder of the elongated surface 203 and the diameter of the opening at the proximal end of the inlet. The diameter of the step-down portion 205 is smaller than the outer diameter of the catheter 230. It should be understood that the catheter 230 within the inlet 204 cannot extend past the step-down portion 205. The instrument lumen 208 extends through the body 202 parallel to the longitudinal axis L from an opening at the proximal end 208p of the body 202 to an opening at the distal end 208d of the body 202. The instrument lumen 208 is configured to receive an instrument 232 extending through the instrument lumen 208. Apertures 210 along the wall 202w of the body 202 are in fluid communication with the cavity portion 206. The cavity portion 206 extends around and is closed off from the instrument lumen 208. The cavity portion 206 is open to a distal end of the inlet 204 to channel fluid delivered from a delivery catheter 230 into the cavity 206 through the inlet 204 and out of the cavity portion 206 through one or more holes 210, such that fluid delivered from the catheter 230 flows into the cavity portion 206 through the inlet 204 and out of the cavity portion 206 through the holes 210, distributing fluid from the catheter 230 and the cavity portion 206 to the exterior of the body 202.

[0032] 3, one embodiment of a fluid dispensing device according to the present disclosure is shown including a body 300 having a wall 302 extending along a longitudinal axis of the body 300. An inlet 304 extends through a proximal end of the body 300 into a cavity portion 306 defined by the body 300. The inlet 304 is in fluid communication with the cavity portion 306 and is configured to receive a distal end of a delivery catheter 330. An instrument lumen 308 extends through the body 300 and is configured to receive an instrument 332 extending through the body 300. There is a hole 310 along the wall 302 of the body 300 in fluid communication with the cavity portion 306. The cavity portion 306 extends around the instrument lumen 308 and is closed off relative to the instrument lumen 308. The hollow portion 306 is open to a distal end of the inlet 304 to convey fluid delivered from a delivery catheter 330 from the inlet 304 into the hollow portion 306 and out of the hollow portion 306 through the holes 310 .

[0033] 4A and 4B, an embodiment of a fluid dispensing device according to the present disclosure is shown, the fluid dispensing device includes a body 400 having a proximal end 400p, a distal end 400d, and a wall 402 having a width extending along a longitudinal axis L of the body 400. The body 400 defines a cavity portion 406. There is an inlet 404 through the proximal end 400p of the body 400. The inlet 404 extends into and is in fluid communication with the cavity portion 406. A transition zone 405 is between the inlet 404 and the cavity portion 406 and is in fluid communication with each of the inlet 404 and the cavity portion 406. Each of the inlet 408 and the cavity portion 406 can include at least a portion of the transition zone 405. The transition zone 405 increases in volume in a distal direction (i.e., in a direction substantially toward the distal end of the body 400). The inlet 404 is configured to receive the distal end of a delivery catheter. The lumen 408, capable of receiving a medical instrument therethrough, extends through the body 400 along a longitudinal axis L from an opening at the proximal end 408p of the body 400 to an opening at the distal end 408d of the body 400. There is an interior wall 412 within the body 400 about the lumen 408 that defines an insulating annulus 414 between the lumen 408 and the cavity portion 406. The insulating annulus can substantially insulate the lumen 408 from fluids within the cavity portion 406. The holes 410 are disposed about and extend through the width of the wall 402 of the body 400 and are in fluid communication with the cavity portion 406, such that fluid delivered from the catheter can flow into the cavity portion 406 through the inlet 404 and out of the cavity portion 406 through the one or more holes 410. The holes 410 are circumferentially disposed about the wall 402 to enable circumferential spray coverage of the body lumen. The diameter and distribution of the holes 410 can vary along and about the axis L to establish desired spray field characteristics, e.g., to achieve substantially uniform flow through all of the holes 410. The cavity portion 406 extends about the lumen 408 and is closed to the lumen 408. The cavity portion 406 is open to a distal end of the inlet 404 via a transition zone 405 that communicates between the inlet 404 and the cavity portion 406 to convey fluid delivered from the delivery catheter from the inlet 404 into the cavity portion 406 and out of the cavity portion 406 through the holes 410.The cavity portion 406 may be configured to provide uniform flow distribution, for example, by tapering the surface profile of the inner wall 412 along the axis, filling the cavity portion 406 with a porous medium (e.g., packed or sintered powders, textiles, or other engineered fillers known to those skilled in the art (pin fin arrays, guide vane arrays, photochemically etched screens, etc.)), or modifying the wetted surfaces of the cavity portion 406 to promote substantially uniform phase distribution (e.g., designating surface roughness to selectively promote or inhibit turbulence, applying hydrophobic or hydrophilic coatings, and combinations thereof). The distal end 408d includes annular barbs 416 extending distally from the distal end 408d of the lumen 408 and configured to interact with a tubular member in fluid communication with the lumen 408. The tubular member may be held in place by the barbs and may not extend distally relative to the body 400.

[0034] 5, one embodiment of a fluid distribution system according to the present disclosure is shown, including a fluid distribution device 501 coupled to a delivery catheter 530 via an inlet 504 that receives the catheter 530. A tubular member 534 extends distally from a lumen 508 of a body 502 of the device 501. The tubular member 534 interfaces with an annular barb 516 at the distal end of the lumen 508. The tubular member 534 can be held in place by the barb and extends distally out of the lumen 508. The tubular member 534 can extend distally past the target tissue and into the patient (e.g., into the stomach). A sheath 536 surrounds the catheter 530 with an air or vacuum gap 531 that insulates the catheter 530. The sheath 536 also includes a fluid pathway 532 in fluid communication with the proximal end of the lumen 508 and the tubular member 534. The fluid pathway 532 may be configured as an instrument channel to accommodate insertion of one or more endoscopic instruments, such as a CDT. For example, an instrument may be inserted into the fluid pathway 532, through the lumen 508 into the tubular member 534, and out the distal end of the tubular member 534. The instrument may be fixed in position relative to the tubular member 534, or may be slidably translated through the tubular member 534. The instrument may have protrusions that create friction with the wall of the tubular member. The sheath 536 may be a multi-lumen extrusion. The system includes an expandable member 538 that expands and contracts with distal and proximal translation of an actuation member 540 at a handle (not shown) at the proximal end of the device 501, via a tether 544 that extends proximally along the sheath 536. Other actuation means are contemplated. The expandable member 538 is retracted to a contracted position during insertion, repositioning, and removal of the system from the patient. The expandable member 538 can be expanded and contacted to the walls of a body lumen to establish patency, widen the body lumen, spread or smooth the tissue to be treated, and / or center an instrument within the lumen to be treated. The sheath 536 includes markings 542 that can be used to assist a medical professional in measuring the lumen, positioning the device, and tracking the treatment within the patient.The sheath 536 also includes a passive venting channel 550 extending proximally from the patient, thereby allowing for passive venting of fluids from within the patient's body (e.g., active or passive venting via the fluid pathway 532 and / or via an instrument extending through the fluid pathway 532) in addition to or in lieu of CDT. The expandable member 538 can have a substantially cylindrical shape supported by, for example, one or more of a shape memory element, a braided pattern, or a flexible gel or adhesive that can be partially solidified over a portion of the expandable member 538 to affect the shape of the expandable member 538.

[0035] 6, one embodiment of a fluid distribution system according to the present disclosure is shown including a fluid distribution device 601 coupled via an inlet 604 to an annulus channel 630 of a sheath 636. The inlet 604 is substantially an annulus channel 630 that circumferentially surrounds a lumen 608 that extends through the device 601. The annulus channel 630 is in fluid communication with holes around the device 601 such that fluid may be delivered from the annulus channel 630 through the holes. The inlet 604 may transition from a small diameter at the proximal end of the inlet 604 (at the annulus channel 630) to a larger diameter at the distal end of the inlet 604 distally (at the body 602 of the distribution device 601). The annulus channel 630 extends proximally along the sheath 636 and is in fluid communication with a delivery catheter. An instrument may be in fluid communication with the inlet 604 and / or may extend through the lumen 608. The sheath 636 also includes an air or vacuum gap 631 around the annulus channel 630 that insulates the annulus channel 630 such that the lumen 608 may be substantially insulated from fluids supplied within the device 601. The lumen 608 is in fluid communication with a fluid pathway extending proximally along the sheath 636 within the annulus channel 630, but is not in fluid communication with the annulus channel 630. Isolating the lumen 608 from the annulus channel 630 allows the lumen 608 to maintain an independent path from the fluid supplied to the annulus channel 630 (e.g., isolating a cryogen fluid pathway from the lumen 608, which may function as a cryo-reduced pressure pathway). An expandable member 638 may be disposed about the fluid distribution device 601. The member is shown in an expanded configuration in Figure 6 and can be expanded and contracted with distal and proximal translation of an actuation member 640 about the sheath 636 via a tether that extends proximally along the sheath 636 to outside the patient's body for actuation by a medical professional. The expandable member 638 can have a substantially cylindrical shape supported by, for example, one or more of a shape memory element, a braided pattern, or a flexible gel or adhesive that can be partially solidified over a portion of the expandable member 638 to affect the shape of the expandable member 638.

[0036] 7A-7G, one embodiment of a fluid distribution system according to the present disclosure is shown including a delivery catheter 720 surrounded by an insulating layer 722 along portions of its length. The delivery catheter 720 has a proximal end 720p, a distal end 720d, and a delivery lumen therebetween. A fluid distribution device 700 is coupled to the distal end 720d of the catheter. The device 700 has a body 712 having a proximal end 712p, a distal end 712d, and a wall 712w having a width extending therebetween along a longitudinal axis L of the body 712. The device 700 has an inlet 704 through the proximal end 712p of the body 712 configured to receive the distal end 720d of the delivery catheter 720. There may be raised elements 714 (e.g., ribs) disposed on the wall 712w of the body 712 extending radially outward from the longitudinal axis L. One or more channels 716 in the body 712 extend from the inlet 704 to one or more channel holes (not shown) in the wall 712w. Each of the one or more channel holes is located between adjacent raised elements 714. Each space between adjacent raised elements 714 can have a single channel hole or multiple holes. The channel 716 is in fluid communication with the inlet 704 at a proximal end and in fluid communication with the spaces between adjacent raised elements 714 at a distal end via the channel holes. An instrument lumen 708 extends through the body 712 along the longitudinal axis L from a proximal opening 708p at a proximal end of the body 712p to a distal opening 708d at a distal end of the body 712d. A medical instrument 726 extends through the instrument lumen 708. 7F shows a cross-sectional view at F-F of a sheath 736 with a delivery catheter 720, a medical device 726, and a passive ventilation lumen 750 around the catheter 720 and device 726. The passive ventilation lumen 750 is fluidly connected to one or more ventilation inlets 751, through the sheath 736, which may be proximal to the device 700, and to one or more proximal outlets 752 such that fluid can passively flow from within the system and / or out of the patient through, for example, ventilation outlet holes 752 of FIG.

[0037] 7A-7G, an elongated tubular member 702 having spray holes 710 surrounds a body 712. The spray holes 710 are arranged in rows around the elongated tubular member 702 such that the spray holes 710 are located between adjacent raised elements 714. However, in various embodiments, the holes 710 and raised elements 714 can be in other arrangements between the channel 716 and the channel holes and the spray holes 710 depending on the desired application and effect. A first cuff 728 is disposed about the distal end 712d of the body 712 which extends the instrument lumen 708 by providing a support surface for the medical instrument 726 to slide within and against the first cuff 728 without contacting the instrument lumen 708. The outer contour of the cuff 728 can provide a gradually tapered contour for atraumatic intubation. The system includes an expandable member 730 around the fluid dispensing device 700 . The expandable member 730 is a braided mesh, but may comprise other expandable materials, such as, for example, a compliant or non-compliant balloon. A proximal end 730p of the expandable member 730 is fixed relative to the delivery catheter 720, and a distal end 730d of the expandable member 730 is fixed relative to the medical device 726. The attachment points of the expandable member 730 allow translational movement of the medical device 726 to distally extend and proximally retract the distal end 730d of the expandable member 730 independent of the proximal end 730p. This allows for manipulation of the expandable member 730. For example, the distal end 730d can be moved toward the proximal end 730p such that the expandable member 730 transitions to the expanded configuration shown in FIG. 7D. As another example, the distal end 730d can be moved distally away from the proximal end 730p such that the expandable member 730 transitions to the contracted configuration shown in FIG. 7E.

[0038] 7A-7G, translational movement of the medical device 726 may be manipulated by using a handle 734 having a slider 732 coupled to a proximal portion of the medical device 726. The proximal end 730p and distal end 730d of the expandable member 730 may be fixed in place to various portions of the system such that the proximal end 730p is fixed relative to the catheter 720 and the distal end 730d is fixed in place relative to the medical device 726. The proximal end 730p of the expandable member 730 is fixed to a sheath 736 that houses the catheter 720 and the device 726, but may alternatively be fixed to the catheter 726 and / or the insulating layer 722, for example. The distal end 730d of the expandable member 730 is fixed to an extension tube 738 extending from the medical device 726, but may alternatively be fixed to the medical device 726, for example. The medical device 726 extends through the first cuff 728 and through a second cuff 740 which is also secured to the inside of a proximal portion of the extension tube 738. The distal end 730d of the expandable member 730 is secured by a coating 742 which extends from the distal end 730d of the expandable member 730 towards the proximal end 730p of the expandable member 730. The coating 742 forms a diaphragm configured to substantially prevent fluid from passing distally past the coating 742 (e.g., cryospray). The coating 742 substantially fills gaps in the mesh of the expandable member 730 where the coating 742 is applied to form a continuous fluid diaphragm. The coating 742 can be a flexible elastomeric coating to allow the expandable member 730 to deform as it transitions between the expanded and contracted configurations. The coating 742 can be applied such that the walls are generally frustum-shaped, funnel-shaped, or similarly shaped while the expandable member 730 is in the expanded configuration. The coating 742 can increase the stiffness of the expandable member 730 where the expandable member 730 and coating 742 contact, such that the shape and radial stability of the expandable member 730 is enhanced by the coating 742. The coating 742 can include a variety of materials, such as, for example, urethane, molded thermoplastic, thermoplastic urethane, thermoset urethane, pebax, thermoplastic elastomers, etc.The second cuff 740 can allow for insertion and removal of the instrument 726 into the system and / or patient independent of the insertion or removal of the remainder of the system. The second cuff 740 fluidly couples the instrument 726 to the extension tube 738. The second cuff 738 can also adjust the position of the instrument 726, for example, to position ventilation holes 752, which can be active or passive, to remove fluid from the treatment area proximally via the instrument 726. As mentioned above, other means of attaching the components to one another are contemplated, such as fasteners, pins, clips, welding, etc.

[0039] 8A and 8B, one embodiment of a fluid dispensing device according to the present disclosure is shown, the fluid dispensing device includes a body 812 having a proximal end 812p, a distal end 812d, and a wall 812w having a width extending therebetween along a longitudinal axis L of the body 812. An inlet 804 extends through the proximal end 812p of the body 812 and is configured to receive a distal end of a delivery catheter. The body 812 includes raised elements 814 (e.g., ribs) disposed on the wall 812w that extend radially outward from the longitudinal axis L. The body 812 includes channels 816 that extend from a channel inlet 816p in the inlet 804 of the body 812 and each extend independently to a channel hole 816d in the wall 812w. Each channel 816 extends to a channel hole 816d between adjacent raised elements 814. Each space between adjacent raised elements 814 has only one channel hole 816d, however, each space may have additional channel holes 816d to meet the flow needs of the procedure. The channel 816 is in fluid communication with the inlet 804 and the spaces between adjacent raised elements 814 via the channel holes 816d. The partial cross-sectional views of Figures 8A and 8B show portions of the channel 816 that extend throughout the body 812. The channels 816 are configured to distribute the flow of fluid from the channel inlets 816p, through the channels 816 along the body 812, through the channel holes 816d, into the spaces between adjacent raised elements 814, and can be used to inject the fluid circumferentially around the outside of the wall 812w and finally out the spray holes 810. Because the diameter of the channel holes 816d is larger than the diameter of each spray hole 810, the fluid can flow approximately around the wall 812w in the spaces between adjacent raised elements 814 before flowing through the spray holes 810 due to the reduced diameter in the fluid flow path. The diameters of the channel holes 816d can be different from each other, for example, such that the distribution of the fluid is substantially uniformly distributed out of the holes 810 between the spaces.

[0040] 8A and 8B, a lumen 808 extends through the body 812 in a direction substantially along the longitudinal axis L from a proximal opening 808p at a proximal end of the body 812 to a distal opening 808d at a distal end 812d of the body 812. The lumen 808 is configured to receive a medical instrument therethrough. An elongated tubular member 802 surrounds the body 812 having spray holes 810. The spray holes 810 are arranged in a row around the elongated tubular member 802 such that the spray holes 810 are disposed between adjacent raised elements 814. However, in various embodiments, the arrangement of the holes 810 and raised elements 814 can be in other arrangements between the channel 816, the channel holes 816d, and the spray holes 810 depending on the desired application and effect. The raised elements 814 are in substantial contact with the elongated tubular member 802. The inlet 804 includes a convex protrusion 820 oriented in a substantially proximal direction (i.e., such that the apex of the convex protrusion 820 is oriented in a substantially proximal direction). The channel 816 is disposed about the convex protrusion 820 such that a flow of fluid into the inlet 804 can contact the convex protrusion 820 and the fluid can be directed radially away from the apex of the convex protrusion 820, generally toward the channel inlet 816p. The flow can be distributed within the channel 816 in a substantially uniform manner.

[0041] In these and various other embodiments, the expandable member may be expanded into contact with a body lumen to position the device / system within the patient's body, for example, at a substantially central point of the body lumen, such that the holes in the device are substantially equidistant from the walls of the body lumen (i.e., centered within the lumen), or positioned at some other predetermined distance or orientation relative to the body lumen. The expandable member may also be expanded into contact with the walls of the body lumen to establish patency.

[0042] In various embodiments described herein or otherwise within the scope of the present disclosure, one or more holes along the wall of the body can be spray holes. The holes can be substantially perpendicular to the instrument lumen, the wall of the body, or both. The holes can be straight lumens that run through the wall. The holes can be frusto-conical in shape, with the inner diameter of the wall being larger than the outer diameter of the wall, or vice versa. The one or more holes can be at an angle to the wall, which angle can be from about 15 degrees to about 165 degrees. One or more of the holes can be angled to the wall (e.g., not perpendicular to the wall), while one or more of the holes are perpendicular to the wall. The one or more holes can generate a spray pattern around the entire circumference of the body, which can be about 360° around the body. The holes can be circles, semicircles, slots, rings, channels, etc.

[0043] In various embodiments, different materials may be selected for various parts of the device or assembly. For example, various portions of the catheter body or device body may be constructed of stainless steel, cobalt alloy, platinum alloy, combinations thereof, or the like. The tube may be laser welded to the body at one or both ends. The expandable member may be constructed of PET, PEEK, nylon, stainless steel, or Nitinol, or combinations thereof, etc. The coating may be constructed of urethane, molded thermoplastic, thermoplastic urethane, thermoset urethane, Pebax, or thermoplastic elastomer, or combinations thereof, etc. The sheath may be constructed of coil or braid reinforced polymer, or polymer encapsulated laser cut metal tubing. The sheath may be provided with or without a lubricious liner such as PTFE or PFA. The exterior of the sheath may include a lubricious additive such as Propell or Kemamide. Polymers for the sheath include Pebax, urethane, polyimide, polyamide, combinations thereof, etc. The insulation may be constructed of PET braid (e.g., for discrete point contact thermally weak connections), or PET heat shrink material (e.g., for a barrier to fluid ingress), or combinations thereof, etc. The catheter may be constructed of laminates of laser cut stainless steel tubing, PET heat shrink tubing, coil reinforced polymers such as Pebax, or combinations thereof, etc.

[0044] In various embodiments described herein or otherwise within the scope of the present disclosure, the cavity portion of the body may be an annulus. The cavity portion may include a plurality of flow channels within the cavity portion configured to distribute flow from the inlet evenly through the cavity portion and out of the one or more channels and spray holes. The channels may include walls having a transition radius that directs the flow from the inlet proximally toward the one or more holes in a substantially distal direction. The channels may also direct the flow from the inlet around the cavity portion. The channels may help distribute the flow evenly throughout the cavity so that the cryospray from the holes is applied to the body lumen in a substantially symmetric coverage pattern and / or volume, or an asymmetric pattern and / or volume, as desired.

[0045] In various embodiments described herein or otherwise within the scope of the present disclosure, the cavity portion may be within the housing and about the instrument lumen. The housing can have a proximal end with an inlet extending into the proximal end in fluid communication with the cavity portion. The inlet of the housing can be configured to receive a distal end of a catheter configured to deliver a cryogen fluid. The housing can have one or more holes in fluid communication with the cavity portion. The one or more holes of the housing can be directed radially from the housing.

[0046] In various embodiments described herein or otherwise within the scope of the present disclosure, the channel holes and spray holes can have various dimensions and can have ratios that increase or decrease the flow rate through them. The height, width, and distance between the raised elements, the dimensions of the inlets, the number and orientation of the channels and holes, the thickness of the various walls of the body and / or the walls of the internal manifold, and the transition zones can all be selected, modified, and / or optimized for the desired application, fluid used, and / or therapeutic effect. For example, for LN2, the hole diameter can range from about 0.003 inches (0.0762 mm) to about 0.012 inches (0.3048 mm), the annular thickness can range from about 0.005 inches (0.127 mm) to about 0.030 inches (0.762 mm), and the wall can range from about 0.005 inches (0.127 mm) to about 0.20 inches (0.508 mm).

[0047] In various embodiments described herein or otherwise within the scope of the present disclosure, the body can have a pear-shaped cross-section. The body can have other cross-sections, such as circular or oval, shapes that have substantially uniform boundaries around the entrance and instrument lumen, and other shapes that can be easily translated within the body lumen. The body can have a rounded tip shape at the distal end. The rounded tip shape can aid in inserting the device into the body lumen while minimizing trauma to the body lumen. The body can be laser cut hypotube, a polymer, or another biocompatible material.

[0048] In various embodiments described herein or otherwise within the scope of the present disclosure, the catheters, instruments, and / or tubular members may be removable from the fluid dispensing device. The devices may be permanently attached to the catheters, instruments, and / or tubular members. Attachment may include bonding, welding, brazing, and the like.

[0049] In various embodiments described herein or otherwise within the scope of the present disclosure, the inlet may be parallel to the instrument lumen. The instrument in, in fluid communication with, or proximate to the instrument lumen may be an endoscope, a guidewire, a CDT, and / or the like. The one or more instruments may be adjacent to the catheter. The inlet and / or instrument lumen may include one or more detents configured to mate with protrusions on the catheter to lock the one or more instruments in a position relative to the inlet, for example, such that there is a fixed interval between spray treatments when the device is allowed to translate along the instrument. The instrument lumen may include a channel or track that may be used to slide the instrument along the instrument lumen while maintaining a circumferential orientation of the instrument relative to the dispensing device. The inlet may have a diameter configured to interact with the catheter such that the catheter and the inlet substantially contact each other. A transition zone may be between the inlet and the cavity portion and in fluid communication with each of the inlet and the space portion. The transition zone may be configured to increase in volume distally. The transition zone can include one or more interior walls configured to distribute a flow of fluid received from the inlet and conveyed substantially toward the cavity portion.

[0050] In various embodiments described herein or otherwise within the scope of the present disclosure, the insulating annulus may be a substantially sealed vacuum chamber, a low conductivity fill medium suitable for use in the cryogenic temperature range, or the insulating annulus may be open to the exterior of the device at the proximal and / or distal ends.

[0051] In various embodiments described herein or otherwise within the scope of the present disclosure, the lumen can include annular barbs extending distally from the lumen and configured to interact with a tubular member in fluid communication with the lumen. The barbs can interact with an inner surface of the tubular member. The barbs can be other shapes, such as rings, domes, annuli, cut-out channels, protrusions, bumps, etc., that can provide friction and interaction with the tubular member such that the tubular member is held substantially in place. The instrument lumen can extend distally past the body of the device to provide an interface for the tubular member to slide over.

[0052] In various embodiments described herein or otherwise within the scope of the present disclosure, the expandable member can be a mesh, braid, spring, balloon, or other expandable feature. The expandable member may be porous such that the cryospray is substantially unhindered from contacting the body lumen. As discussed above, the expandable member can be used to open a body lumen and / or to place a device or instrument within the body lumen.

[0053] Embodiments of the method of dispensing a fluid such as a cryospray can include a medical professional inserting a device of the present disclosure into a body lumen. The device can include a delivery catheter with a distal end of the delivery catheter within the device. An additional instrument can be received within the device and extended through the device. The medical professional can treat a desired portion of a substantially annular section or a portion of an annular section of the body lumen without the spray being impeded by the additional instrument. The spray translating proximally and distally away from the treatment site within the body lumen can be passively or actively (e.g., by suction) expelled to the atmosphere with the additional instrument.

[0054] All of the devices and / or methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure. Although the devices and methods of the present disclosure have been described with respect to preferred embodiments, it will be apparent to those skilled in the art that modifications can be made to these devices and / or methods in the steps or in the sequence of steps of the methods described herein without departing from the spirit and scope of the present disclosure. All such similar substitutes and modifications apparent to those skilled in the art are deemed to be within the spirit and scope of the present disclosure, as defined by the appended claims.

Claims

1. An apparatus comprising: The device comprises: a body having a proximal end, a distal end and a wall having a width extending therebetween along a longitudinal axis of the body; the body defining a cavity portion and an instrument lumen; The hollow portion extends through the body from a proximal end to a distal end, the instrument lumen extends through the body and is parallel to a longitudinal axis from an opening at a proximal end of the body to an opening at a distal end of the body; the instrument lumen is configured to receive an instrument extending therethrough; an inlet at the proximal end of the body, the inlet extends into and is in fluid communication with the cavity portion; the inlet configured to receive a distal end of a delivery catheter; one or more holes along a wall of the body in fluid communication with the cavity portion; the one or more holes being configured to allow fluid delivered from the catheter through the inlet to the cavity portion to exit; An apparatus having

2. The apparatus of claim 1 , wherein the inlet comprises an elongated surface extending at least partially into the cavity portion.

3. The apparatus of claim 2 , wherein the elongated surface includes a step-down portion within the cavity portion, the step-down portion having a diameter smaller than a diameter of the remainder of the elongated surface.

4. the hollow portion is an annulus; The device of claim 1 , wherein the cavity portion extends around and is closed to an instrument lumen.

5. further comprising a plurality of flow channels within the cavity portion; The flow channel is configured to distribute flow from the inlet through the cavity portion and out of the one or more holes.

2. The apparatus of claim 1.

6. the one or more holes include a frusto-conical shape spanning a width of the wall of the body; the diameter of the hole on the inner surface of the wall is greater than the diameter of the hole on the outer surface of the wall; 2. The apparatus of claim 1.

7. 13. A system comprising the device of claim 1 having an expandable member associated with the device of claim 1.

8. further comprising a coating extending partially from the distal end of the expandable member toward the proximal end of the expandable member; the coating is configured to substantially prevent fluid from passing distally past the coating; The system of claim 7.

9. An apparatus comprising: The device comprises: a body having a proximal end, a distal end and a wall having a width extending therebetween along a longitudinal axis of the body; the body defining a hollow portion and a lumen; the lumen extends through the body and is parallel to a longitudinal axis from an opening at a proximal end of the body to an opening at a distal end of the body; an inlet at the proximal end of the body, the inlet configured to receive a distal end of a delivery catheter; a transition zone between the inlet and the cavity portion, the transition zone having a volume increasing in a distal direction; one or more holes along a wall of the body in fluid communication with the cavity portion; the one or more holes being configured to allow fluid delivered from the catheter through the inlet to the cavity portion to exit; An apparatus having

10. The apparatus of claim 9 , wherein the transition zone includes one or more interior walls configured to distribute a flow of fluid received from an inlet through the cavity portion toward one or more holes.

11. The apparatus of claim 9 , wherein the hollow portion is an annulus, the hollow portion extending around and closed off from an instrument lumen.

12. 12. The apparatus of claim 11 further comprising: an inner wall around the lumen within the body; the inner wall defines an insulating annulus between the lumen and the cavity portion; 12. The apparatus of claim 11.

13. 13. The apparatus of claim 12, wherein the insulating annulus is a substantially sealed vacuum chamber or a low conductivity fill medium suitable for use within the cryogenic temperature range.

14. 10. The apparatus of claim 9, wherein the cavity portion is configured to provide uniform flow distribution by filling it with a porous media or other engineered filler material or by modifying wetted surfaces of the cavity portion to promote substantially uniform phase distribution.

15. The apparatus of claim 12 , wherein the cavity portion is configured to provide uniform flow distribution by tapering a surface of the inner wall along a longitudinal axis of the body.

16. 10. A system comprising the device of claim 9, further comprising an expandable member spanning the device.

17. An apparatus comprising: The device comprises: a body having a proximal end, a distal end and a wall having a width extending therebetween along a longitudinal axis of the body; the body defining a hollow portion and a lumen; the lumen extends through the body and is parallel to a longitudinal axis from an opening at a proximal end of the body to an opening at a distal end of the body; the hollow portion is an annulus, the hollow portion extending around and closed to an instrument lumen; an inlet in fluid communication with the proximal end of the body and the hollow portion, the inlet is a substantially annular channel circumferentially surrounding the lumen; the inlet configured to couple to an annulus channel for supplying a fluid; one or more holes along a wall of the body in fluid communication with the cavity portion; the one or more holes are configured to allow the fluid provided from the annulus channel through the inlet to the cavity portion to flow out; An apparatus having

18. 20. The device of claim 17, wherein the inlet transitions from a smaller diameter at the annulus channel to a larger diameter at an end of the inlet distally in the body of the device.

19. 20. The device of claim 17, further comprising an air or vacuum gap around the annulus channel that is substantially insulated from the fluid provided within the device.

20. 20. A system comprising the device of claim 17, further comprising an expandable member spanning the device.

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