Patent Description:
Various catheters are used within body lumens for various applications, including to deliver fluids, as a diagnostic or treatment option, to a body lumen. The fluid may be a liquid, a gas, or a mixture of both a liquid and a gas. The delivery may involve spraying the fluid on a wall of the body lumen. In some cases, the efficacy and/or efficiency of the procedure may be dependent on how unobstructed the delivered fluid is to the wall of the body lumen from the catheter and/or spray device. For example, document <CIT> discloses a direct stream hydrodynamic catheter system. Document <CIT> discloses a device for endoscopic advancement through the small intestine.

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 typically referred to as cryoablation systems, cryospray systems, cryospray ablation systems, cryosurgery systems, cryosurgery spray systems and/or cryogen spray ablation systems. As typically used, "cryogen" refers to any fluid (e.g., gas, liquefied gas or other fluid known to one of ordinary skill in the art) with a sufficiently low boiling point (i.e., below
approximately -<NUM>) for therapeutically effective use during a cryogenic surgical procedure. Suitable cryogens may include, for example, argon, nitrogen and helium. Pseudo-cryogens such as carbon dioxide and nitrous oxide that have a boiling temperature above -<NUM>, but still very low when compared to atmospheric and bodily temperatures (e.g., -<NUM> for N<NUM>O, -<NUM> for CO<NUM>), may also be used.

During operation of a cryospray system, a medical professional (e.g., clinician, technician, medical professional, surgeon and the like) may direct a cryogen spray onto the surface of a treatment area via a cryogen delivery catheter. The medical professional may target the cryogen spray visually through a video-assisted device or endoscope, such as a bronchoscope, gastroscope, colonoscope, ureteroscope, or pediatric scope. Cryogen spray may exit the cryogen delivery catheter at a temperature ranging from <NUM> to -<NUM>, causing the target tissue to freeze.

Procedures in the body at treatment sites may include catheters along with other instruments necessary to the procedures, in various forms, for different applications, and across a range of treatment sites. For example, during spray cryotherapy, a cryodecompression tube (CDT), gas removal tube (GRT), or gas egress tube (GET) must be placed into the stomach before treating the esophagus in order to evacuate cryogen gas that is generated during the treatment. The tube typically may lay remote to the treatment device against the surface of the body lumen, which may create an untreated area behind the tube, with respect to the spray device (i.e., the tube may block the cryogen spray from reaching the tissue at the treatment site). During therapy, if the tube masks the cryospray, the adjacent tissue may be prevented from fully freezing. The clinician must remove and reorient the tube and/or cryogen delivery device/catheter in a different position to treat the untreated area or return for a second procedure. Such tubes or other instruments may be placed over a guidewire; however, guidewires present an additional potential obstruction in the working channel of the endoscope or at the treatment site, or both.

It is with respect to these considerations that the devices and systems of the present disclosure may be useful.

The present disclosure in its various embodiments includes devices and systems for distribution of fluids, such as cryospray, and may be used to more efficiently deliver and distribute fluids to treatment areas in tandem with other medical instruments. Such devices may provide, among other benefits, a more efficient coverage of treatment fluid, such as cryospray, at treatment sites. Various embodiments allow instruments to extend through a lumen of a device that also has a cavity portion for fluid delivery, allowing for fluids and/or spray to be uninhibited by instruments at the treatment site.

In various embodiments, a device may 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 may define a cavity portion and an instrument lumen. An inlet may be at the proximal end of the body. The inlet may extend into and may be in fluid communication with the cavity portion. The inlet may be configured to accept a distal end of a delivery catheter. The instrument lumen may extend through the body and may 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 may be configured to receive an instrument extending therethrough. One or more apertures may be along the wall of the body in fluid communication with the cavity portion, so that a fluid delivered from the catheter may flow into the cavity portion through the inlet and out of the cavity portion through the one or more apertures.

In various embodiments described here and otherwise, the inlet may include an elongate surface extending at least partially into the cavity portion. The elongate surface may include a step-down portion within the cavity portion. The step-down portion may have a diameter that is smaller than a diameter of the remainder of the elongate surface. The one or more apertures may include spray apertures. The cavity portion may be an annulus. The cavity portion may extend about and may be closed to the instrument lumen. The cavity portion may be open to the inlet so as to convey a fluid delivered from the delivery catheter into the cavity portion through the inlet and out of the cavity portion through the one or more apertures. The body may have a pear-shaped cross-section. The inlet may be parallel to the instrument lumen. The catheter may be removably attachable to the body. The catheter may be permanently attached to the body. The instrument lumen may be substantially perpendicular to the one or more apertures. The body may have a blunt tip at the distal end. A plurality of flow channels may be within the cavity portion. The flow channels may be configured to distribute flow from the inlet, through the cavity portion, and out the one or more apertures. The one or more apertures may include a straight lumen extending through the wall of the body. The one or more apertures may include a frusto-conical shape spanning the width of the wall of the body. A diameter of the apertures that may be on an interior surface of the wall may be larger than a diameter of the apertures that may be on an exterior surface of the wall. The one or more apertures may span a width of the wall at an angle perpendicular to the wall. The one or more apertures may span a width of the wall at an angle to the wall. The angle may be about <NUM> degrees to about <NUM> degrees. Some of the one or more apertures may span the width of the wall at an angle that is not perpendicular to the wall. Some of the other one or more apertures may span the width of the wall at an angle perpendicular to the wall. The one or more apertures may create a spray pattern of fluid delivered therefrom about a full circumference of the body.

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

In various of the embodiments described here and otherwise, an expandable member may be included with the system disposed about the body of the fluid distribution device. The expandable member may have a proximal end fixed in position with respect to the delivery catheter. The expandable member may have a distal end fixed in position with respect to the medical instrument. A coating may extend from a distal end of the expandable member and partially toward a proximal end of the expandable member. The coating may be configured to substantially block fluids from advancing distally. An extension tube may be fixed in position with respect to and may extend distally from a distal end of the expandable member. The distal end of the expandable member may be fixed in position 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 block fluids from advancing distally past the adhesive. The inlet may extend parallel to the instrument lumen. The medical instrument may be one of an endoscope, a guidewire, or a cryodecompression tube, or a combination thereof. A detent may be within the inlet and may be configured to mate with a projection on the catheter to lock the catheter in position with respect to the inlet. The plurality of raised elements may be ribs that extend circumferentially about the longitudinal axis. The body may be permanently attached to the catheter. The spray apertures may be substantially straight lumens through the elongate tubular member. The plurality of spray apertures may include a frusto-conical shape spanning the width of a wall of the elongate tubular member. A diameter of the apertures on an interior surface of the wall may be larger than the diameter on an exterior of the wall. The one or more apertures may span a width of a wall of the elongate tubular member at an angle perpendicular to the longitudinal axis. The one or more apertures may span a width of a wall of the elongate tubular member at an angle to the longitudinal axis. The angle may be about <NUM> degrees to about <NUM> degrees. Some of the one or more apertures may span a width of a wall of the elongate tubular member at an angle that is not perpendicular to the longitudinal axis. Other of the one or more apertures may span the width of the wall at an angle perpendicular to the longitudinal axis.

In various embodiments, a device may include a housing that may have a proximal end, a distal end, and extend along a longitudinal axis. An instrument lumen may extend through the housing parallel to the axis from the proximal end to the distal end of the housing. The housing may have a cavity portion defined interior to the housing and extending circumferentially about the instrument lumen. An inlet may extend into the cavity portion from the proximal end of the housing. The inlet may be in fluid communication with the cavity portion and may be configured to accept a distal end of a cryogen fluid delivery catheter. One or more apertures in the housing may be in fluid communication with the cavity portion and may be configured to distribute the cryogen fluid from the catheter and the cavity portion exterior to the housing.

In various of the embodiments described here and otherwise, the one or more apertures may be oriented perpendicular to the longitudinal axis. The inlet may have a diameter configured to interface with the catheter such that the catheter and the inlet may be in substantial contact with each other when coupled together. A plurality of flow channels may be within the cavity portion and may be configured to evenly distribute flow of the cryogen fluid from the catheter from the inlet, through the cavity portion, and out of the one or more apertures. A detent at the inlet may be configured to mate with a projection on the catheter to lock the catheter in position with respect to the inlet.

In various embodiments, a device may 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 may define a cavity portion. An inlet may extend through the proximal end of the body. The inlet may extend into and may be in fluid communication with the cavity portion. The inlet may be configured to accept a distal end of a delivery catheter. A lumen may 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 inner wall may be within the body and may be about the lumen that defines an insulating annulus between the lumen and the cavity portion. One or more apertures may be disposed about and extending through the width of the wall of the body in fluid communication with the cavity portion, so that a fluid delivered from the catheter may flow into the cavity portion through the inlet and out of the cavity portion through the one or more apertures. The insulating annulus may be a substantially sealed vacuum chamber or low-conductivity fill medium suitable for use in the cryogenic temperature range. A transitioning zone may be between and in fluid communication with the inlet and the cavity portion. The transitioning zone may increase in volume in a distal direction. The transitioning zone may include one or more interior walls that may be configured to distribute a flow of the fluid received from the inlet toward the one or more apertures through the cavity portion. The distal end of the lumen may contain an annular barb that may be configured to interface with a tubular member that may extend distally from the lumen and in fluid communication with the lumen. The lumen may extend distally past the body. The body may include a laser cut hypotube. The cavity portion may extend about and may be closed to the instrument lumen. The cavity portion may be open to the inlet so as to convey a fluid delivered from the delivery catheter into the cavity portion through the inlet and out of the cavity portion through the one or more apertures.

In various embodiments, a device may 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. An inlet may be at the proximal end of the body. The inlet may be configured to couple to a distal end of a delivery catheter. A plurality of raised elements may be disposed on the wall. Portions of the raised elements may extend radially outward from the longitudinal axis. A plurality of channel apertures may each be disposed on the wall between adjacent raised elements of the plurality of raised elements. A plurality of channels may be in fluid communication with the inlet and may each extend to a respective one or more of the plurality of channel apertures. A lumen may extend through the body substantially in a direction along 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 lumen may be configured to accept a medical instrument therethrough. An elongate tubular member may be disposed about the body. A plurality of spray apertures may be disposed about the elongate tubular member. The spray apertures may be disposed between the raised elements.

In various of the embodiments described here and otherwise, the plurality of raised elements may be in substantial contact with the elongate tubular member.

The present disclosure is not limited to the embodiments described. The terminology used herein is only for the purpose of describing particular embodiments and is not intended to be limiting. Unless otherwise defined, all technical terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the disclosure belongs.

Although embodiments of the present disclosure may be described with specific reference to cryogen fluid distribution from a catheter within the esophagus or bronchi and with a cryodecompression tube (CDT), it should be appreciated that such devices and systems may be used with a variety of fluids, with a variety of instruments, and for a variety of other body passageways, organs and/or cavities, such as the vascular system, urogenital system, upper gastrointestinal system, lower gastrointestinal system, and the like.

It will be further understood that the terms "comprises" and/or "comprising," or "includes" and/or "including" when used herein, specify the presence of stated portions, regions, steps elements and/or components, but do not preclude the presence or addition of one or more other portions, regions, integers, steps, operations, elements, components and/or groups thereof.

As used herein, the conjunction "and" includes each of the structures, components, portions, or the like, which are so conjoined, unless the context clearly indicates otherwise, and the conjunction "or" includes one or the others of the structures, components, portions, or the like, which are so conjoined, singly and in any combination and number, unless the context clearly indicates otherwise.

As used herein, the term "distal" refers to the end farthest away from the medical professional along a system or device when introducing the system or device into a patient, while the term "proximal" refers to the end closest to the medical professional along the system or device when introducing the system or device into a patient.

The devices of the present disclosure may be used with cryoablation systems to distribute the flow of cryospray gases (hereafter referred to as "cryogen" or "cryospray") within a body lumen. Exemplary cryoablation systems with which the present disclosure may be implemented include, but are not limited to, those systems described commonly owned <CIT>,<CIT>, and <CIT> and <CIT>, <CIT>, and <CIT>. In various embodiments, features and advantages of distributing fluid can be realized throughout this disclosure as well as throughout the disclosure of co-owned United States Provisional Patent Application filed concurrently herewith, entitled "Systems and Methods to Enhance Radial Spray from a Catheter" to Downey et al. (Attorney Docket No. <NUM>).

The term "about", in the context of numeric values, generally refers to a range of numbers that one of skill in the art would consider equivalent to the recited value (i.e., having the same function or result). Other uses of the term "about" (i.e., in a context other than numeric values) may be assumed to have their ordinary and customary definition(s), as understood from and consistent with the context of the specification, unless otherwise specified.

The recitation of numerical ranges by endpoints includes all numbers within that range, including the endpoints (e.g. <NUM> to <NUM> includes <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, and <NUM>).

Further, when a particular feature, structure, or characteristic is described in connection with an embodiment, it would be within the knowledge of one skilled in the art to affect such feature, structure, or characteristic in connection with other embodiments, whether or not explicitly described, unless clearly stated to the contrary.

Various embodiments of the present disclosure allow for a variety of endoscopic instruments (e.g. a CDT, biopsy devices, stent sizers, stent delivery systems, and the like) to be received and extended through an instrument lumen of a fluid distribution device while a distal end of a delivery catheter is accepted through an inlet of a device. Once the instrument, device, and catheter are advanced to a desirable location in the body lumen, a fluid, such as a cryogen, may be delivered through the catheter, into an inlet of the device, and out of one or more apertures. A fluid sprayed from the one or more apertures may reach a target tissue of a patient without being impeded by the endoscopic instrument extending through the instrument lumen.

With reference to <FIG>, an embodiment of a fluid distribution system according to the present disclosure is illustrated, which includes a delivery catheter <NUM> having a proximal end, a distal end, and a lumen therebetween. A fluid distribution device <NUM> is coupled to the distal end of the catheter <NUM>. The device <NUM> has a body <NUM> with a proximal end, a distal end, and a wall having a width extending therebetween along a longitudinal axis of the body <NUM>. The body <NUM> defines a cavity portion and an instrument lumen <NUM>. The instrument lumen <NUM> extends through the body <NUM>. The device <NUM> has an inlet <NUM> at the proximal end of the body <NUM>. The inlet <NUM> extends into and is in fluid communication with the cavity portion. The inlet <NUM> accepts the distal end of the delivery catheter <NUM>. The device <NUM> includes apertures <NUM> along the wall of the body <NUM> in fluid communication with the cavity portion, so that a fluid delivered from the catheter <NUM> flows into the cavity portion through the inlet <NUM> and out of the cavity portion through the apertures <NUM> to distribute a fluid from the catheter <NUM> and the cavity portion exterior to the body <NUM>. An instrument <NUM>, e.g., a CDT or the like, is received within the instrument lumen <NUM> and extends therethrough. An endoscope <NUM>, e.g., a pediatric scope or the like, external to the system may be used to observe and position the device <NUM>, catheter <NUM>, and instrument <NUM>. The system is shown inserted into a body lumen <NUM>, and the device <NUM> is position such that the system may treat a target tissue <NUM>.

With reference to <FIG>, an embodiment of a fluid distribution device <NUM> according to the present disclosure is illustrated, which includes a body <NUM> having a proximal end 202p, a distal end 202d, and a wall 202w having a width extending therebetween extending along a longitudinal axis L of the body <NUM>. The body <NUM> defines a cavity portion <NUM> and an instrument lumen <NUM>. There is an inlet <NUM> through the proximal end 202p of the body. The inlet <NUM> extends into and is in fluid communication with the cavity portion <NUM>. The inlet <NUM> is configured to accept a distal end of a delivery catheter <NUM>. The inlet <NUM> includes an elongate surface <NUM> that extends at least partially into the cavity portion <NUM>. The elongate surface <NUM> has a step-down portion <NUM> within the cavity portion <NUM>, creating a diameter of the opening at the distal end of the inlet that is smaller than a diameter of the remainder of the elongate surface <NUM> and the diameter of the opening at the proximal end of the inlet. The diameter of the step-down portion <NUM> is smaller than the outer diameter of the catheter <NUM>. It should be appreciated that the catheter <NUM> within inlet <NUM> cannot extend past the step-down portion <NUM>. An instrument lumen <NUM> extends through the body <NUM> parallel with the longitudinal axis L from an opening at the proximal end 208p to an opening at the distal end 208d of the body <NUM>. The instrument lumen <NUM> is configured to receive an instrument <NUM> extending therethrough. Apertures <NUM> along the wall 202w of the body <NUM> are in fluid communication with the cavity portion <NUM>. The cavity portion <NUM> extends about and is closed to the instrument lumen <NUM>. The cavity portion <NUM> is open to the distal end of the inlet <NUM>, so as to convey a fluid delivered from the delivery catheter <NUM> into the cavity <NUM>, through the inlet <NUM>, and out of the cavity portion <NUM> through the one or more apertures <NUM>, so that the fluid delivered from the catheter <NUM> flows into the cavity portion <NUM> through the inlet <NUM> and out of the cavity portion <NUM> through the apertures <NUM> to distribute the fluid from the catheter <NUM> and the cavity portion <NUM> exterior to the body <NUM>.

Referring to <FIG>, an embodiment of a fluid distribution device according to the present disclosure is illustrated, which includes a body <NUM> having a wall <NUM> extending along a longitudinal axis of the body <NUM>. An inlet <NUM> extends through the proximal end of the body <NUM> and into a cavity portion <NUM> that is defined by the body <NUM>. The inlet <NUM> is in fluid communication with the cavity portion <NUM> and is configured to accept a distal end of a delivery catheter <NUM>. An instrument lumen <NUM> extends through the body <NUM> and is configured to receive an instrument <NUM> extending therethrough. There are apertures <NUM> along the wall <NUM> of the body <NUM> in fluid communication with the cavity portion <NUM>. The cavity portion <NUM> extends about and is closed to the instrument lumen <NUM>. The cavity portion <NUM> is open to the distal end of the inlet <NUM>, so as to convey a fluid delivered from the delivery catheter <NUM> into the cavity portion <NUM> through the inlet <NUM> and out of the cavity portion <NUM> through the apertures <NUM>.

Referring to <FIG> and <FIG>, an embodiment of a fluid distribution device according to the present disclosure is illustrated, which includes a body <NUM> having a proximal end 400p, a distal end 400d, and a wall <NUM> having a width extending along a longitudinal axis L of the body <NUM>. The body <NUM> defines a cavity portion <NUM>. There is an inlet <NUM> through the proximal end 400p of the body <NUM>. The inlet <NUM> extends into and is in fluid communication with the cavity portion <NUM>. A transitioning zone <NUM> is between and in fluid communication with each of the inlet <NUM> and the cavity portion <NUM>. The inlet <NUM> and the cavity portion <NUM> may each include at least a portion of the transitioning zone <NUM>. The transitioning zone <NUM> increases in volume in a distal direction (i.e., in a direction substantially toward the distal end of the body <NUM>). The inlet <NUM> is configured to accept a distal end of a delivery catheter. A lumen <NUM>, which may accept a medical instrument therethrough, extends through the body <NUM> along the longitudinal axis L from an opening at the proximal end 408p to an opening at the distal end 408d of the body <NUM>. There is an inner wall <NUM> within the body <NUM> that is about the lumen <NUM> that defines an insulating annulus <NUM> between the lumen <NUM> and the cavity portion <NUM>. The insulating annulus may substantially insulate the lumen <NUM> from a fluid within the cavity portion <NUM>. There are apertures <NUM> disposed about and extending through the width of the wall <NUM> of the body <NUM> in fluid communication with the cavity portion <NUM>, so that a fluid delivered from a catheter flows into the cavity portion <NUM> through the inlet <NUM> and out of the cavity portion <NUM> through the one or more apertures <NUM>. The apertures <NUM> are arranged circumferentially about the wall <NUM> to allow for circumferential spray coverage of a body lumen. The diameter and distribution of apertures <NUM> may be varied along and about the axis L to establish desired spray field properties, for example, to achieve substantially uniform flow through all the apertures <NUM>. The cavity portion <NUM> extends about and is closed to the lumen <NUM>. The cavity portion <NUM> is open to the distal end of the inlet <NUM> via the transition zone <NUM> communicating between the inlet <NUM> and the cavity portion <NUM>, so as to convey a fluid delivered from the delivery catheter through the inlet <NUM> into the cavity portion <NUM> and out of the cavity portion <NUM> through the apertures <NUM>. The cavity portion <NUM> may be configured to create uniform flow distribution, for example by tapering the profile of a surface of the inner wall <NUM> along the axis L, by filling the cavity portion <NUM> with a porous medium (e.g., packed or sintered powders, textiles, or other engineered fillers (such as pin-fin arrays, guide vane arrays, photochemical etched screens, etc.) known to those familiar with the art), or modifying the wetted surfaces of the cavity portion <NUM> to promote a substantially uniform phase distribution (e.g., specifying surface roughness to selectively promote or inhibit turbulence, applying hydrophobic or hydrophilic coatings, and combinations thereof). The distal end 408d includes an annular barb <NUM> configured to interface with a tubular member that extends distally from the distal end 408d of the lumen <NUM> and is in fluid communication with the lumen <NUM>. The tubular member may be retained in place by the barb and may extend the lumen <NUM> distal to the body <NUM>.

Referring to <FIG>, an embodiment of a fluid distribution system according to the present disclosure is illustrated, which includes a fluid distribution device <NUM> coupled to a delivery catheter <NUM> via an inlet <NUM> that accepts the catheter <NUM>. A tubular member <NUM> extends distally from a lumen <NUM> of a body <NUM> of the device <NUM>. The tubular member <NUM> interfaces with an annular barb <NUM> of a distal end of the lumen <NUM>. The tubular member <NUM> may be retained in place by the barb and extends the lumen <NUM> distally. The tubular member <NUM> may extend distally into a patient, past the target tissue (e.g., into the stomach). A sheath <NUM> surrounds the catheter <NUM> with an air or vacuum gap <NUM> that insulates the catheter <NUM>. The sheath <NUM> also includes a fluid pathway <NUM> that is in fluid communication with a proximal end of the lumen <NUM> and the tubular member <NUM>. The fluid pathway <NUM> may be configured as an instrument channel to accept the insertion of one or more endoscopic instruments, such as a CDT. For example, an instrument may be inserted into the fluid pathway <NUM> and through the lumen <NUM> into the tubular member <NUM> and out the distal end of tubular member <NUM>. The instrument may be fixed in position with respect to the tubular member <NUM> or may slidably be translated therethrough. The instrument may have a projection to create friction with a wall of the tubular member. The sheath <NUM> may be a multi-lumen extrusion. The system includes an expandable member <NUM> that expands and collapses with the distal and proximal translation of an actuating member <NUM> at a handle (not shown) at the proximal end of the device <NUM> via a tether <NUM> that extends proximally along the sheath <NUM>. Other means of actuation are contemplated. The expandable member <NUM> is retractable into a collapsed position during insertion, relocation, and removal of the system from the patient. The expandable member <NUM> may be expanded and made to contact the walls of a body lumen to establish patency, widen the body lumen, unfold or smooth out tissue to be treated, and/or center the instrument within the lumen to be treated. The sheath <NUM> includes markings <NUM> that may be used to aid a medical professional in measuring lumens, positioning devices, and tracking treatment within the patient. The sheath <NUM> also includes a passive venting channel <NUM> that extends proximally out of the patient, allowing for the passive ventilation of fluids from within the patient in addition to or in place of a CDT (e.g., active or passive ventilation through the fluid pathway <NUM>, and/or through an instrument extending through the fluid pathway <NUM>). An expandable member <NUM> may have a substantially cylindrical shape that is supported by, e.g., one or more of shape memory elements, a braiding pattern, or a flexible gel or adhesive that may partially solidify throughout a portion of the expandable member <NUM> to influence its shape.

Referring to <FIG>, an embodiment of a fluid distribution system according to the present disclosure is illustrated, including a fluid distribution device <NUM> coupled to an annulus channel <NUM> of a sheath <NUM> via an inlet <NUM>. The inlet <NUM> is a substantially annular channel <NUM> that circumferentially surrounds a lumen <NUM> extending through the device <NUM>. The annular channel <NUM> is in fluid communication with the apertures about the device <NUM> such that a fluid may be supplied from the annular channel <NUM> and through the apertures. The inlet <NUM> may transition from a smaller diameter at a proximal end of the inlet <NUM> (at the annulus channel <NUM>), to a larger diameter in the distal direction and at the distal end of the inlet <NUM> (at the body <NUM> of the distribution device <NUM>). The annulus channel <NUM> extends proximally along the sheath <NUM> and is in fluid communication with a delivery catheter. An instrument may be in fluid communication with the inlet <NUM> and/or may extend through the lumen <NUM>. The sheath <NUM> also includes an air or vacuum gap <NUM> about the annulus channel <NUM> that insulates the annulus channel <NUM>, such that the lumen <NUM> may be substantially insulated from a fluid supplied into the device <NUM>. The lumen <NUM> is in fluid communication with a fluid pathway that extends proximally along the sheath <NUM> within the annulus channel <NUM> but is not in fluid communication with the annulus channel <NUM>. The separation of the lumen <NUM> from the annulus channel <NUM> allows for the lumen <NUM> to maintain a pathway independent of any fluid supplied to the annulus channel <NUM> (e.g., separating a cryogen fluid pathway from the lumen <NUM> that may act as a cryodecompression pathway). An expandable member <NUM> may be disposed about the fluid distribution device <NUM>. The member is shown in an expanded configuration in <FIG> and may be expanded and collapsed with the distal and proximal translation of the actuating member <NUM> about the sheath <NUM> via a tether that extends proximally along the sheath <NUM> and out of the patient for actuation by a medical professional. An expandable member <NUM> may have a substantially cylindrical shape that is supported by, e.g., one or more of shape memory elements, a braiding pattern, or a flexible gel or adhesive that may partially solidify throughout a portion of the expandable member <NUM> to influence its shape.

Referring to <FIG>, an embodiment of a fluid distribution system according to the present disclosure is illustrated, which includes a delivery catheter <NUM> that is enclosed in insulating layers <NUM> along portions of its length. The delivery catheter <NUM> has a proximal end 720p, a distal end 720d, and a delivery lumen therebetween. A fluid distribution device <NUM> is coupled to the distal end 720d of the catheter. The device <NUM> has a body <NUM> 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 <NUM>. The device <NUM> has an inlet <NUM> through the proximal end 712p of the body <NUM> that is configured to accept the distal end 720d of the delivery catheter <NUM>. There may be raised elements <NUM> disposed on the wall 712w of the body <NUM> that extend radially outward from the longitudinal axis L (e.g., ribs). One or more channels <NUM> in the body <NUM> extend from the inlet <NUM> to one or more channel apertures (not shown) in the wall 712w. Each of the one or more channel apertures are situated between adjacent raised elements <NUM>. Each space between adjacent raised elements <NUM> may have a single channel aperture or multiple apertures. The channels <NUM> are in fluid communication with the inlet <NUM> at a proximal end and are in fluid communication with the space between adjacent raised elements <NUM> at the distal end via the channel apertures. An instrument lumen <NUM> extends through the body <NUM> along the longitudinal axis L from a proximal opening 708p at the proximal end of the body 712p to a distal opening 708d at the distal end of the body 712d. A medical instrument <NUM> extends through the instrument lumen <NUM>. <FIG> illustrates a cross-sectional view of the sheath <NUM> at F-F having a delivery catheter <NUM>, a medical instrument <NUM>, and a passive ventilation lumen <NUM> about the catheter <NUM> and the instrument <NUM>. The passive ventilation lumen <NUM> is in fluid connection with a proximal outlet or outlets <NUM> so that fluids may passively flow proximally from one or more ventilation inlets <NUM> through the sheath <NUM> that may be proximal to the device <NUM>, and out of the system and/or patient through, e.g., ventilation outlet apertures <NUM> in <FIG>.

Still referring to <FIG>, an elongate tubular member <NUM> having spray apertures <NUM> surrounds the body <NUM>. The spray apertures <NUM> are arranged about the circumference of the elongate tubular member <NUM> in rows such that the spray apertures <NUM> are disposed between adjacent raised elements <NUM>. However, in various embodiments the apertures <NUM> and raised elements <NUM> could be of another arrangement among the channels <NUM>, channel apertures, and spray apertures <NUM>, depending on the desired application and effects. A first cuff <NUM> is disposed about a distal end 712d of the body <NUM> that extends the instrument lumen <NUM> by providing a bearing surface for the medical instrument <NUM> to slide within and against the first cuff <NUM> without the medical instrument <NUM> contacting the instrument lumen <NUM>. The outer profile of cuff <NUM> may provide a gradually tapering profile for atraumatic intubation. The system includes an expandable member <NUM> about the fluid distribution device <NUM>. The expandable member <NUM> is a braided mesh, but may comprise other expandable materials such as, e.g., a compliant or non-compliant balloon, or the like. A proximal end 730p of the expandable member <NUM> is fixated with respect to the delivery catheter <NUM> and a distal end 730d of the expandable member <NUM> is fixated with respect to the medical instrument <NUM>. The attachment points of the expandable member <NUM> allow for translation of the medical instrument <NUM> to distally extend and proximally retract the distal end 730d of the expandable member <NUM> independent of the proximal end 730p. This allows for manipulation of the expandable member <NUM>. For example, the distal end 730d may be moved toward the proximal end 730p such that the expandable member <NUM> transitions into an expanded configuration as illustrated in <FIG>. As another example, the distal end 730d may be moved distally away from the proximal end 730p such that the expandable member <NUM> transitions into a collapsed configuration as illustrated in <FIG>.

Still referring to <FIG>, translation of the medical instrument <NUM> may be manipulated by using a handle <NUM> that has a slider <NUM> coupled to a proximal portion of the medical instrument <NUM>. The proximal and distal ends 730p, 730d of the expandable member <NUM> may be fixed in position to various portions of the system in order for the proximal end 730p to be fixated with respect to the catheter <NUM> and the distal end 730d to be fixed in position with respect to the medical instrument <NUM>. The proximal end 730p of the expandable member <NUM> is fixed to a sheath <NUM> containing the catheter <NUM> and the instrument <NUM>, but may instead, e.g., be fixed to the catheter <NUM> and/or insulation layer(s) <NUM>. The distal end 730d of the expandable member <NUM> is fixed to an extension tube <NUM> that extends from the medical instrument <NUM>, but may instead, e.g., be fixed to the medical instrument <NUM>. The medical instrument <NUM> extends through the first cuff <NUM> and also a second cuff <NUM> that is fixed to an inside of a proximal portion of the extension tube <NUM>. The distal end 730d of the expandable member <NUM> is fixed by a coating <NUM> that extends from the distal end 730d of the expandable member <NUM> toward the proximal end 730p of the expandable member <NUM>. The coating <NUM> forms a barrier membrane that is configured to substantially block fluids from advancing distally past the coating <NUM> (e.g., cryospray). The coating <NUM> substantially fills-in gaps in the mesh of the expandable member <NUM> where it is applied to form a continuous fluid barrier. The coating <NUM> may be a flexible elastomeric coating to allow for deformation when the expandable member <NUM> transitions between the expanded configuration and the collapsed configuration. The coating <NUM> may be applied while the expandable member <NUM> is in the expanded configuration such that the wall is generally frustum-shaped, funnel-shaped, or the like. The coating <NUM> may increase the stiffness of the expandable member <NUM> where the two are in contact such that the shape and radial stability of the expandable member <NUM> is reinforced by the coating <NUM>. The coating <NUM> may comprise a variety of materials such as, e.g., a urethane, a molded thermoplastic, thermoplastic urethane, thermosetting urethane, pebax, thermoplastic elastomer, or the like. The second cuff <NUM> may allow for the insertion and removal of the instrument <NUM> into the system and/or into a patient independent of insertion or removal of the remaining parts of the system. The second cuff <NUM> fluidly couples the instrument <NUM> to the extension tube <NUM>. The second cuff <NUM> may also adjust the position of the instrument <NUM>, e.g., to position ventilation apertures <NUM> that may be active or passive to remove fluid from the treatment area and proximally through the instrument <NUM>. Other means of attachment of the components with respect to each other, as described above, are contemplated, such as fasteners, pins, clips, welds, and the like.

Referring to <FIG> and <FIG>, an embodiment of a fluid distribution device according to the present disclosure is illustrated, which includes a body <NUM> 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 <NUM>. An inlet <NUM> extends through the proximal end 812p of the body <NUM> and is configured to accept a distal end of a delivery catheter. The body <NUM> includes raised elements <NUM> disposed on the wall 812w that extend radially outward from the longitudinal axis L (e.g., ribs). The body <NUM> includes channels <NUM> that extend from channel inlets 816p in the inlet <NUM> of the body <NUM>, and each extend independently to a channel aperture 816d in the wall 812w. Each channel <NUM> extends to a channel aperture 816d between adjacent raised elements <NUM>. Each space between adjacent raised elements <NUM> has only one channel aperture 816d, but each space may have additional channel apertures 816d to meet flow needs of a procedure. The channels <NUM> are in fluid communication with the inlet <NUM> and the space between adjacent raised elements <NUM> via the channel aperture 816d. The partial cross-sectional views of <FIG> and <FIG> illustrate portions of the channels <NUM> extending throughout the body <NUM>. The channels <NUM> are configured to distribute a flow of fluid from the channel inlets 816p, through the channels <NUM> along the body <NUM>, out of the channel apertures 816d, into the space between adjacent raised elements <NUM> and may be used to inject fluid circumferentially about an exterior of the wall 812w, and finally out of the spray apertures <NUM>. The diameter of the channel apertures 816d is larger than the diameter of each spray aperture <NUM> such that a fluid may flow generally about the circumference of the wall 812w in the spaces between adjacent raised elements <NUM> before flowing through the spray apertures <NUM> due to a reduction in diameter in the flow path of the fluid. The diameters of channel apertures 816d may be varied among each other such that, e.g., a distribution of fluid is substantially uniformly distributed among the spaces and out of the apertures <NUM>.

Still referring to <FIG> and <FIG>, a lumen <NUM> extends through the body <NUM> substantially in a direction along the longitudinal axis L from a proximal opening 808p at the proximal end of the body <NUM> to a distal opening 808d at the distal end 812d of the body <NUM>. The lumen <NUM> is configured to accept a medical instrument therethrough. An elongate tubular member <NUM> surrounds the body <NUM> that has spray apertures <NUM>. The spray apertures <NUM> are arranged about the circumference of the elongate tubular member <NUM> in rows such that the spray apertures <NUM> are disposed between adjacent raised elements <NUM>. However, in various embodiments, the arrangement of apertures <NUM> and raised elements <NUM> could be of another arrangement among the channels <NUM>, channel apertures 816d, and spray apertures <NUM>, depending on the desired application and effects. The raised elements <NUM> are in substantial contact with the elongate tubular member <NUM>. The inlet <NUM> includes a convex protrusion <NUM> that is oriented in a substantially proximal direction (i.e., such that an apex of the convex protrusion <NUM> is oriented in a substantially proximal direction). The channels <NUM> are arranged about the convex protrusion <NUM> such that a flow of fluid into the inlet <NUM> may contact the convex protrusion <NUM> and the fluid may be directed radially away from the apex of the convex protrusion <NUM> and generally toward the channel inlets 816p. The flow may be distributed in a substantially uniform manner into the channels <NUM>.

In various of the above and other embodiments, expanding an expandable member into contact with a body lumen may be done to position a device/system within a patient, for example, at the substantially central point of the body lumen, such that apertures of a device are substantially equidistant from the walls of the body lumen (i.e., centered within the lumen) or positioned as some other predetermined distance or orientation with respect to the body lumen. The expandable member may also expand into contact with the walls of a body lumen to establish patency.

In various embodiments described here or otherwise within the scope of the present disclosure, the one or more apertures along the wall of the body may be spray apertures. The apertures may be substantially perpendicular to the instrument lumen, the wall of the body, or both. The apertures may be a straight lumen through the wall. The apertures may be a frusto-conical shape with a diameter on the interior of the wall larger than a diameter on the exterior of the wall or vice versa. The one or more apertures may be at an angle to the wall, and the angle may be about <NUM> degrees to about <NUM> degrees. One or more of the apertures may be angled to the wall (e.g., not perpendicular to the wall) while one or more of the apertures are perpendicular to the wall. The one or more apertures may create a spray pattern about a full circumference of the body, which may be about <NUM>° about the body. The apertures may be circles, semi-circles, slots, rings, channels, and the like.

In various embodiments, different materials may be selected for various parts of a device or assembly. For example, various portions of a catheter body or a device body may be made up of a stainless steel, a cobalt alloy, a platinum alloy, a combination thereof, or the like. A tube may be laser welded to a body at one or both ends. An expandable member may be made up of PET, PEEK, nylon, stainless steel, or nitinol, or a combination thereof, or the like. A coating may be made up of a urethane, a molded thermoplastic, a thermoplastic urethane, a thermosetting urethane, Pebax, or a thermoplastic elastomer, or a combination thereof, or the like. A sheath may be made up of a coil or braid reinforced polymer, or a polymer encapsulated laser cut metallic tube. A sheath may be provided with or without a lubricious liner, such as PTFE, PFA. An exterior of the sheath may include a lubricious additive, such Propell, or Kemamide. Polymers for the sheath may include Pebax, urethane, polyimide, polyamide, a combination thereof, or the like. Insultation may be made up of a PET braid (e.g., for weak thermal connection with discrete point contact), or a PET heat shrink material (e.g., for barrier to fluid ingress), or a combination thereof, or the like. A catheter may be made up of a laminate of laser cut stainless steel tubing, PET heat shrink tubing, coil-reinforced polymer, such as Pebax, or a combination thereof, or the like.

In various embodiments described here 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 that are configured to evenly distribute flow from the inlet, through the cavity portion, and out the one or more channel and spray apertures. These channels may include walls with a transitioning radius that directs flow from the inlet proximally, toward the one or more apertures in a substantially distal direction. The channels may also direct the flow from the inlet about the cavity portion. The channels may assist in distributing flow evenly throughout the cavity such that cryospray from the apertures is applied to the body lumen in a substantially symmetrical coverage pattern and/or volume, or asymmetrical pattern and/or volume, as desired.

In various embodiments described here or otherwise within the scope of the present disclosure, the cavity portion may be within a housing and about the instrument lumen. The housing may have a proximal end with an inlet extending into the proximal end in fluid communication with the cavity portion. The inlet of the housing may be configured to accept a distal end of the catheter that is configured to deliver a cryogen fluid. The housing may have one or more apertures that are in fluid communication with the cavity portion. The one or more apertures of the housing may be oriented radially from the housing.

In various embodiments described here or otherwise within the scope of the present disclosure, the channel apertures and spray apertures may have a range of dimensions and may have a ratio to increase or decrease a flow rate therethrough. The height, width, and distance between the raised elements, dimensions of the inlet, number and orientation of the channels and apertures, thickness of the various walls of the body and/or walls of the inner manifold, and the transitioning zone may all be chosen, altered and/or optimized for a desired application, fluid used, and/or treatment affect. For example, for LN<NUM>, apertures may range from about <NUM> inches (<NUM>) to about <NUM> inches (<NUM>) in diameter, an annular thickness may range from about <NUM> inches (<NUM>) to about <NUM> inches (<NUM>), and walls may range from about <NUM> inches (<NUM>) to about <NUM> inches (<NUM>).

In various embodiments described here or otherwise within the scope of the present disclosure, the body may have a pear-shaped cross-section. The body may have other cross-sections such as a circular shape, and elliptical shape, a shape that has a substantially uniform border about the inlet and the instrument lumen, and other shapes that may easily translate within a body lumen. The body may have a blunt tip geometry at the distal end. The blunt tip geometry may assist in inserting the device into the body lumen while minimizing trauma to the body lumen. The body may be a laser cut hypotube, a polymer, or another biocompatible material.

In various embodiments described here or otherwise within the scope of the present disclosure, the catheter, instrument, and/or tubular member may be removable from the fluid distribution device. The device may be permanently attached to the catheter, instrument and/or tubular member. Attachment may include bonding, welding, brazing, or the like.

In various embodiments described here or otherwise within the scope of the present disclosure, the inlet may be parallel to the instrument lumen. An instrument within, in fluid communication with, or in proximity 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 the instrument lumen may include one or more detents configured to mate with a projection on the catheter to lock the one or more instruments into a position with respect to the inlet, for example, such that there is fixed spacing between spray treatments, if the device is translatable along the instrument. The instrument lumen may include a channel or track that may be used to slide an instrument along the instrument lumens while maintaining the circumferential orientation of the instrument relative to the distribution device. The inlet may have a diameter configured to interface with the catheter such that the catheter and the inlet are in substantial contact with each other. A transitioning zone may be between and in fluid communication with each of the inlet and the cavity portion. The zone may be configured to increase in volume in a distal direction. The transitioning zone may include one or more interior walls configured to distribute a flow of fluid received from the inlet and conveyed substantially toward the cavity portion.

In various embodiments described here or otherwise within the scope of the present disclosure, an 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 an exterior of the device at a proximal and/or distal end.

In various embodiments described here or otherwise within the scope of the present disclosure, the lumen may include an annular barb configured to interface with a tubular member that extends distally from the lumen and is in fluid communication with the lumen. The barb may interface with an inner surface of the tubular member. The barb may be other shapes such as a ring, a dome, an annulus, a carved-out channel, a protrusion, a bump, or the like that may create friction and interface with the tubular member such that the tubular member is substantially held in place. The instrument lumen may extend distally past the body of a device in order to provide an interface for the tubular member to slide onto.

In various embodiments described here or otherwise within the scope of the present disclosure, the expandable member may be a mesh, braid, spring, balloon, or other expandable feature. The expandable member may be porous such that cryospray may not be substantially obstructed from contacting the body lumen. The expandable member may be used to make a body lumen patent and/or to position a device or instrument within the body lumen, as described above.

Embodiments of a method, not being part of the invention, for distributing fluid, such as cryospray, may include a medical professional inserting a device of the present disclosure into a body lumen. The device may include a delivery catheter with a distal end of the delivery catheter within the device. An additional instrument may be received within and extended through the device. The medical professional may treat a substantially annular section or some desired portion of the annular section of the body lumen without the spray being obstructed by the additional instrument. The spray that translates proximally and distally away from the treatment site within the body lumen may be passively or actively (e.g., by suction) vented to the atmosphere with the additional instrument.

Claim 1:
A device (<NUM>), comprising:
a body (<NUM>) having a proximal end, a distal end, and a wall having a width extending therebetween along a longitudinal axis (L) of the body (<NUM>), the body defining a cavity portion and an instrument lumen (<NUM>);
an inlet (<NUM>) at the proximal end of the body (<NUM>), the inlet extending into and in fluid communication with the cavity portion, the inlet configured to accept a distal end of a delivery catheter (<NUM>);
the instrument lumen (<NUM>) extending through the body (<NUM>) parallel to the longitudinal axis (L) from an opening (708p) at the proximal end of the body (<NUM>) to an opening (708d) at the distal end of the body (<NUM>), the instrument lumen (<NUM>) configured to receive an instrument extending therethrough;
one or more apertures along the wall of the body (<NUM>) in fluid communication with the cavity portion, so that a fluid delivered from the catheter (<NUM>) flows into the cavity portion through the inlet (<NUM>) and out of the cavity portion through the one or more apertures,
an expandable member (<NUM>) about the fluid distribution device (<NUM>),
characterized in that the device (<NUM>) further comprises a coating (<NUM>) extending from a distal end (730d) of the expandable member (<NUM>) and partially toward a proximal end (730p) of the expandable member (<NUM>), the coating (<NUM>) configured to substantially block fluids from advancing distally past the coating (<NUM>).