Patent Publication Number: US-2021177482-A1

Title: Apparatus and system for cryo-therapy balloon

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims the benefit of U.S. provisional application No. 62/578,201, filed 27 Oct. 2018, which is hereby incorporated by reference as though fully set forth herein. 
    
    
     BACKGROUND 
     a. Field 
     This disclosure relates to an elongate medical device. In particular, the instant disclosure relates to apparatuses and systems for cryo-therapy balloons. 
     b. Background Art 
     Electrophysiology catheters are used in a variety of diagnostic and/or therapeutic medical procedures to correct conditions such as atrial arrhythmia, including for example, ectopic atrial tachycardia, atrial fibrillation, and atrial flutter. Arrhythmia can create a variety of dangerous conditions including stasis of blood flow which can lead to a variety of ailments and even death. 
     Typically in a procedure, a catheter is manipulated through a patient&#39;s vasculature to, for example, a patient&#39;s heart, and carries one or more electrodes which may be used for mapping, ablation, diagnosis, or other treatments. Once at the intended site, treatment may include radio frequency (RF) ablation, cryoablation, lasers, chemicals, high-intensity focused ultrasound, etc. An ablation catheter imparts such ablative energy to cardiac tissue to create a lesion in the cardiac tissue. This lesion disrupts undesirable electrical pathways and thereby limits or prevents stray electrical signals that lead to arrhythmias. As readily apparent, such treatment requires precise control of the catheter during manipulation to and at the treatment site, which can invariably be a function of a user&#39;s skill level. 
     In the case of an ablation balloon filled with a fluid/gas, various tissue adjacent the balloon can be ablated to create lesions. In the case of ablation balloons used for cryo-therapy in and proximate a PV, controlling the flow direction of the fluid in the balloon is important for targeting specific tissue adjacent the balloon and avoiding undesired treatment of other tissue adjacent the balloon. 
     BRIEF SUMMARY 
     The instant disclosure, in at least one embodiment, an medical device for providing therapy to tissue, comprises a balloon, a movable manifold, wherein the movable manifold comprises a first plurality of openings and the movable manifold is inside the balloon and the movable manifold is configured to distribute a fluid within the balloon, an elongate shaft with a proximal end portion and a distal end portion, wherein the distal end portion of the elongate shaft is coupled with the balloon, a central lumen, wherein the movable manifold is movably coupled with the central lumen, and a supply lumen comprising a supply lumen proximal end and a supply lumen distal end, wherein the supply lumen is longitudinally movable and in fluid communication with the movable manifold, wherein the movable manifold is configured to move longitudinally in response to an actuation of the supply lumen proximal end. 
     In another embodiment, a medical therapy apparatus comprises a balloon, positioned at a distal end portion of an elongate structure, a central lumen coupled with the balloon, a manifold comprising a first port and a second port in fluid communication with an interior of the balloon, wherein the manifold is coupled with the central lumen, and a movable manifold cover, wherein the movable manifold cover can cover one or more of the first port and the second port and block the fluid communication between the central manifold and the interior of the balloon. 
     In yet another embodiment, a medical device comprises a balloon, positioned at a distal end portion of an elongate structure, a central lumen coupled with the balloon, a movable manifold comprising a distribution element, wherein the manifold is coupled with the central lumen, and a distribution control element movably coupled with the distribution element. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is an exemplary system diagram of a catheter inserted into a body (the heart) with an irrigation system including an energy/fluid supply. 
         FIG. 2A  is partial fragmentary view of a distal end of an elongate medical device coupled with a balloon with a movable manifold, consistent with embodiments in the present disclosure. 
         FIG. 2B  is a partial fragmentary view of the distal end of the elongate medical device coupled with the balloon with the movable manifold of  FIG. 2A , where the movable manifold is translated longitudinally, consistent with embodiments in the present disclosure. 
         FIG. 3  is a cross-sectional view of the supply lumen for the movable manifold of  FIGS. 2A-B , consistent with embodiments in the present disclosure. 
         FIG. 4A  is a partial fragmentary view of a distal end of an elongate medical device coupled with a balloon apparatus with a manifold and a movable opening cover, consistent with embodiments in the present disclosure. 
         FIG. 4B  is a partial fragmentary view of the distal end of the elongate medical device coupled with the balloon with the movable manifold and the port block tube of  FIG. 4A , where the movable opening cover is rotated to block a second opening, consistent with embodiments in the present disclosure. 
         FIG. 5  is a partial fragmentary view of a distal end of an elongate medical device with a balloon with a movable manifold and a pressure sensor, consistent with embodiments in the present disclosure. 
     
    
    
     DETAILED DESCRIPTION OF EMBODIMENTS 
     The instant disclosure relates to catheters for providing an ablation therapy to tissue, and more specifically, ablation of myocardial tissue with electrophysiology catheters within the heart. In particular, the instant disclosure relates to a balloon that uses a fluid flowing through a movable manifold inside the balloon. The tissues, such as myocardial tissues including the pulmonary vein, can receive an ablation therapy from the fluid within the balloon to alleviate symptoms associated with cardiac arrhythmias. The tissue ablation can produce a consistent tissue ablation line along a length and circumference of the pulmonary venous tissue which substantially blocks the transmission of electrical signals between ectopic foci within the pulmonary vein (PV). Details of the various embodiments of the present disclosure are described below with specific reference to the figures. 
     Referring now to the drawings wherein like reference numerals are used to identify similar components in the various views,  FIG. 1  is a system diagram showing a medical device and an energy/fluid supply, in accordance with embodiments of the present disclosure. In some embodiments, and with reference to  FIG. 1 , the system  10  can include a medical device  12  and an energy/fluid supply  16  (e.g., an RF signal generator, a coolant supply, a pump, etc.). The energy/fluid supply  16  can also include an electronic control unit (ECU). In an embodiment, the catheter  12  may be an ablation catheter. The catheter  12  can be configured to be inserted into a patient&#39;s heart  18 . 
     The catheter  12  may include a handle  20  and a shaft  22  having a proximal end portion  24 , a distal end portion  26 , and a tip portion  28  disposed at the distal end portion  26  of the shaft  22 . The catheter  12  may further include other conventional components such as, for example and without limitation, a temperature sensor, a position sensor, a pressure sensor, and/or additional sensors or electrodes, and corresponding conductors or leads. For purposes of illustration and clarity, the description below will be limited to an embodiment wherein the medical device  12  comprises a catheter (a sample catheter is shown in  FIG. 1  (e.g., catheter  12 )). It will be appreciated, however, that the present disclosure is not meant to be limited to catheters 
     The shaft  22  can be an elongate, tubular, flexible member configured for movement within the body  14 . The tip portion  28  of the shaft  22  supports, for example and without limitation, sensors and/or electrodes mounted thereon. The tip portion  28  may include ablation elements (e.g., ablation tip electrodes for delivering RF energy to fluid in a balloon and/or for delivering RF ablative energy to tissue, cryo ablation using a focal tip, including a separate lumen extending to the focal tip). The shaft  22  may also permit transport, delivery, and/or removal of fluids (including irrigation fluids, cryogenic ablation fluids, and bodily fluids), medicines, and/or surgical tools or instruments. 
       FIG. 2A  is a partial fragmentary view of a distal end of an elongate medical device coupled with a balloon with a movable manifold, consistent with embodiments in the present disclosure. The balloon apparatus  30  can include a longitudinal axis defined by the line A-A, the elongate medical device  32  with a distal end  34  coupled to a balloon  36  and a movable manifold  38 . The movable manifold  38  can be slideably coupled with a central lumen  40  of the elongate medical device  32  and within a portion of the balloon  36 . The movable manifold  38  can be connected, for example, to a pump (e.g., a pump that is part of the energy/fluid supply  16  of  FIG. 1 ) by a manifold supply lumen  42 . The manifold supply lumen  42  can be internal and/or external to the central lumen  40  of the elongate medical device  32 . The manifold supply lumen  42  can allow fluid or gas to flow through the movable lumen  38 . For example, the fluid/gas can flow from the energy fluid supply  16  ( FIG. 1 ), through the manifold supply lumen  42 , through the movable manifold  38 , and into the balloon  36 ). In some embodiments, the manifold supply lumen  42  can be divided to allow for greater control of dispersal of the fluid or gas to different portions of the movable manifold. (See  FIG. 3  and related discussion for additional information). 
     The manifold supply lumen  42  can also be sufficiently rigid to be used to move the movable manifold  38  longitudinally as indicated by the arrow B-B. For example, the manifold supply lumen  42  can be coupled with the movable manifold  38  and a control interface can be used to move/translate the movable manifold  38  (e.g., a user can push/pull on the control interface that interacts with a proximal portion of the manifold supply lumen  42  that results in longitudinal movement of the movable manifold  38 ). 
     The movable manifold  38  can include any suitable number and configuration of openings  44  (e.g., orifices, nozzles, fittings and other similar elements) that facilitate a flow of the fluid or a gas from the manifold supply lumen  42  through the movable manifold  38  and into the balloon  36 . A portion of the movable manifold can comprise a distribution element. As shown in  FIG. 2A , the openings  44  can be arranged in a line around the circumference of the movable manifold  38  with equal spacing between the openings  44 . In some embodiments (not shown), the openings  44  can have variable spacing between each opening. The movable manifold  38  can include a movable manifold proximal end  46  and a movable manifold distal end  48 , with openings  44  proximate the movable manifold distal end  48 . 
     The openings  44  can be distributed along the length of the movable manifold  38  with any suitable spacing. The openings  44  can also be spaced radially around the movable manifold  38 . The openings  44  can be positioned to provide various patterns of discharge of the fluid/gas into the balloon  36 . The openings  44  can be, for example, the same size or they can be different sizes or any suitable combination of sizes. The openings  44  can also provide directional control when the fluid/gas is discharged into the balloon  36 . The movable manifold  38  can include openings  44  proximate the movable manifold distal end  48 , proximate the movable manifold proximal end, inbetween those two locations, and/or any combination locations along the movable manifold  38 . In some embodiments, the openings  44  can also include a nozzle on one or more of the openings (not shown). The nozzle can be used to control or direct the flow of the fluid/gas. For example, the nozzle can be configured to direct the fluid/gas to a specific location/area of the balloon  36  or to discharge the fluid/gas in a specific pattern. 
     The openings  44  can include, for example, groups of openings (not shown) at different locations along the length of the movable manifold  38 . For example, a first group of openings can be spaced radially around a first location on movable manifold  38  and a second group of openings can be spaced radially around a second location on the movable manifold  38 . Any suitable number of groups of openings  44  can be used and the number of openings  44  in each group can be the same or different. The sizes of the each of the openings  44  in the various groups can be the same or different. 
     Additional information about configurations for the openings and the supply of fluid can be found in U.S. application Ser. No. 62/457,666 (attorney reference number 065513-001435) filed on 10 Feb. 2017, which is hereby incorporated by reference as if set forth fully herein. The movable manifold  38  can be moved longitudinally (e.g., distally and/or proximally) within the balloon  36  in a direction indicated by the arrow B-B. The movable manifold  38  can be movably coupled with the central lumen  40  (e.g., the movable manifold  38  can slide along the central lumen  40 ). The longitudinal movement of the movable manifold  38  can be achieved by the use of various elements including, for example, the manifold supply lumen  42 , activation and/or pull wires or other similar devices that mechanically couple the movable manifold  38  with a user control (e.g., a handle, etc.) or a combination of these elements. 
     An interior of the manifold  38  can be an expansion chamber. Additional information on embodiments of the manifold and the expansion chamber can be found in U.S. application Ser. No. 62/457,666, filed on 10 Feb. 2017, which is hereby incorporated by reference as if set forth fully herein. 
     The elongate medical device  32  can be an elongated, tubular, and flexible member configured for movement within a patient&#39;s body  14 . The elongate medical device  32  can include the balloon  36  at a distal end  34 . The balloon  36  and the elongate medical device can be combined into a single element or they can be separate elements that are coupled together. The elongate medical device  32  may also permit transport, delivery and/or removal of fluids (including irrigation fluids (e.g., saline), cryogenic ablation fluids/gasses, and body fluids), medicines, and/or surgical tools or instruments. The transport, delivery and/or removal of fluids can be done through, for example, the central lumen  40 , the supply lumen  42 , and/or other lumens. The elongate medical device  32 , which may be made from conventional materials used for catheters, such as polyurethane, can include one or more lumens configured to house and/or transport electrical conductors, fluids, and/or surgical tools. The elongate medical device  32  may be introduced into a blood vessel or other structure within the body  14  through, for example, a conventional introducer sheath. 
     The balloon  36  can be either of a conductive or a nonconductive material and can be either self-erecting or mechanically erected, such as through the use of an internal balloon. In some embodiments, a balloon and an elongate medical device can combined into a single element (not shown). The balloon  36  can be made of any suitable material (e.g., flexible polymers such as nylon, polyamide (e.g., a polyether block amide such as PEBAX), polyurethane, polyethylene terephthalate (PET), etc.). The balloon  36  can be made from a material that is compliant (e.g., expands as internal pressure increases) or non-compliant/semi-compliant (e.g., expands to one specific size or size range, even as internal pressure increases). The balloon  36  can be any suitable shape (round, oval, elliptical, etc.) and can be symmetrical or asymmetrical. 
     The balloon  36  can include two layers (e.g., a first balloon  50  inside of a second balloon  52 ) as shown in  FIG. 2A . In other embodiments (not shown), the balloon  36  can have one layer (e.g., where the layer is considered a single balloon), multiple layers where each layer can be considered a separate balloon (a third balloon, a fourth balloon, etc.), or multiple layers that are considered a single balloon. The various layers of the balloon  36  can be the same shape or they can be different shapes. Additional balloon shapes and configurations are described in U.S. application Ser. No. 62/432,065 (attorney docket no. 065513-001414), filed on 9 Dec. 2016, and U.S. application Ser. No. ______. (attorney docket number 065513-001663, filed concurrently), which are hereby incorporated by reference as if set forth fully herein. 
     In an exemplary embodiment, a lumen (e.g., the central lumen  40 ) extending through a length of a shaft (e.g., a shaft  22  of  FIG. 1 ) of the elongate medical device  32  can inject a fluid (e.g., a fluid and/or a gas) into the balloon  36  which exerts a radial force on the balloon  36  and thereby expands the balloon  36  into a deployed/inflated (e.g., expanded) configuration. The balloon  36  can also be expanded using, for example, a mechanical structure (not shown) that includes a shape memory material (e.g., nitinol) and/or pull wires, activation wires, or other suitable method and hardware. 
       FIG. 2B  is a partial fragmentary view of the distal end of the elongate medical device with the balloon with the movable manifold of  FIG. 2A , where the movable manifold is translated longitudinally, consistent with embodiments in the present disclosure. As described above, the balloon apparatus  30  can include the elongate medical device  32  with the distal end  34  coupled to the balloon  36  and the movable manifold  38  as shown in  FIG. 2A . In  FIG. 2B , the movable manifold  38  has been longitudinally translated distally (e.g., moved more distally as shown in  FIG. 2B ). Translation of the movable manifold  38  can allow for variations in the therapy permitted by the balloon apparatus  30 . For example, translating the movable manifold  38  longitudinally can allow for a different flow pattern of the fluid/gas that is moving into the balloon  36 . This variation in flow can permit, for example, targeting different portions of the balloon  36  with the fluid/gas flowing from the openings  44  of the movable manifold  38 . This can lead to variations in treatment sites of tissue proximate the balloon  36  when the balloon is in contact with tissue (e.g., proximate a PV). 
     In the embodiment shown in  FIGS. 2A-B , the balloon  36  and the elongate medical device  32  can be combined into a single element. In other embodiments, the balloon  36  can be coupled with the elongate medical device  32  where the balloon  36  and the elongate medical device  32  are separate elements (not shown). The balloon  36  can be made of any suitable material (e.g., flexible polymers such as nylon, PEBAX, polyurethane, PET, etc.). The balloon  36  can be any suitable shape (round, oval, elliptical, etc.) and can be symmetrical or asymmetrical. 
       FIG. 3  is a cross-sectional view of the supply lumen and the movable manifold of  FIGS. 2A-B , consistent with embodiments in the present disclosure. The supply lumen  42  can include the first supply lumen portion  54  and the second supply lumen portion  56  to deliver fluid/gas to separate portions of the movable manifold  38 . As shown in  FIG. 3 , the movable manifold  38  can be divided into two portions, where the first supply lumen portion is in fluid communication with a first movable manifold portion  58  and the second supply lumen portion  56  is in fluid communication with a second movable manifold portion  60 . The movable manifold  38  is slideably coupled with the central lumen  40 . This configuration allows for fluid/gas to be separately supplied (e.g., circulated by a pump (e.g., as part of the energy/fluid supply  16  of  FIG. 1 )) to each portion of the movable manifold  38 . In other embodiments (not shown), multiple supply lumens (e.g., two supply lumens, three supply lumens, etc.) can be used instead of a single supply lumen with different portions as shown in  FIG. 3 . 
     One or more pumps can be used to control the circulation of the fluid/gas. For example, a first pump can circulate fluid through the first supply lumen portion  54  and the first portion of the movable manifold  38  and a second pump can supply fluid through the second supply lumen portion  56  and the second portion of the movable manifold  38 . A pump (e.g., as part of the energy/fluid supply  16  of  FIG. 1  or a separate pump (not shown)) can circulate a fluid/gas through, for example, the supply lumen  42 , the movable manifold  38 , and the balloon  36 . The pump can also circulate the fluid/gas through other elements of the system  10  of  FIG. 1  (e.g., a portion of the shaft  32  and/or the handle  20  of  FIG. 1 , etc.). Multiple pumps can be used to control circulation of a fluid. 
     In the embodiment shown in  FIG. 3 , the movable manifold  38  is separated into two portions by longitudinally dividing the movable manifold into the first movable manifold portion  58  (e.g., the left half of the movable manifold  38  cross-section in  FIG. 3 ) and the second movable manifold portion  60  (e.g., the right half of the movable manifold  38  cross-section in  FIG. 3 ). In another embodiment (not shown), the movable manifold can be divided into two portions creating a proximal movable manifold portion and a distal movable manifold portion (e.g., radially dividing the movable manifold  38 ). 
     In another embodiment (not shown), the first movable manifold portions  58  and the second movable manifold portion  60  can be separated into different portions. For example, the first movable manifold portion  58  and the second manifold portion  60  can each have a proximal portion and a distal portion. The supply lumen can be correspondingly coupled (e.g., in fluid communication) with the various portions of the movable manifold  38  to provide the fluid/gas to individual portions to allow for separate control/application of the specific portion as described herein. In other embodiments, the movable manifold can include multiple portions (e.g., a third movable manifold portion, a fourth movable manifold portion, etc.) where the supply lumen includes additional divisions to allow for individual control of the additional movable manifold portions. 
     In some embodiments (not shown), a movable manifold  38  can be divided such that separate supplies of fluid/gas can distribute the fluid/gas to various openings in the movable manifold  38  (e.g., three supply manifold portions to three separate portions of the movable manifold, four supply manifold portions to four separate portions of the movable manifold, etc.). In another embodiment, the supply lumen can have a path for fluid flow and supply the entire movable manifold  38  (not shown). 
       FIG. 4A  is a partial fragmentary view of a distal end of an elongate medical device coupled with a balloon apparatus with a manifold and a movable opening cover, consistent with embodiments in the present disclosure. The elongate medical device  32 A can include a balloon apparatus  30 A that includes a balloon  36 A, and a central lumen  40 A, where the central lumen  40 A is inside the balloon  36 A. A movable opening cover  62  (i.e., a movable manifold cover, a distribution apex, a distribution control element) can be slideably and rotatably coupled with the central lumen  40 A. The central lumen  40 A can include openings  44 A (e.g., ports). The movable opening cover  62  can slide longitudinally (e.g., proximally and/or distally as indicated by an arrow D-D) and rotate about a longitudinal axis of the central lumen  40 A (e.g., clockwise and counterclockwise as indicated by an arrow E-E) to cover a portion of the movable manifold  38 A. The elongate medical device  32 A and the balloon apparatus  30 A can share a longitudinal axis defined by the line C-C. 
     As the movable opening cover  62  is moved (e.g., rotated as indicated by the arrow E-E and/or translated longitudinally as indicated by the arrow D-D), it can cover one or more of the openings  44 A in the movable manifold  38 A slideably coupled with the central lumen  40 A. A shape of the movable opening cover  62  can include a triangular shape and/or an apex, that facilitates covering one or more of the openings  44 A of the movable manifold  38 A. In some configurations, the movable opening cover  62  can cover at least half of the openings  44 A. Covering half of the openings  44 A can allow for selected directionality of the flow of fluid/gas into the balloon  36 A. In other embodiments, the movable manifold cover  62  can cover a portion of an opening  44 A. This directionality can allow for protection and/or isolation of various portions of tissue and adjacent biological features. For example, when the balloon apparatus  30  is positioned proximate the PV, the phrenic nerve can be protected by moving the movable opening cover  62  into a first position that blocks a first set of openings (e.g., one or more openings) on the movable lumen  38 A that would prevent the coolant/gas from being directed towards tissue proximate the phrenic nerve. 
     The movable opening cover  62  can be moved to a second position to cover a second set of openings (e.g., one or more openings where at least one opening is not part of the first set of openings) as needed. The need to move the movable opening cover  62  to the second position can be determined by any suitable method, including monitoring and/or sensors (e.g., diaphragm monitoring, temperature sensors, pacing catheters (e.g., phrenic pacing catheters), thermal probes (e.g., thermal probes) attached to the elongate medical device  32 A, the central lumen  40 A, the movable opening cover  62 , the balloon  36 A, or other suitable locations of the balloon apparatus or another device. 
     Position stops (not shown) can be used to set the location of the movable opening cover  62  to aid is positioning the movable opening cover  62  in a desired position with regards to the first position and the second position. For example, a first position stop can be used to set the movable opening cover  62  to the first opening and a second position stop can be used to set the movable opening cover  62  to cover the second opening. Additional position stops can be used depending in the number of openings  44 A to be covered. The position stops can be, for example, mechanical (e.g., features or elements on one or more of the movable opening cover  62 , the central lumen  40 A, and/or the movable manifold  38 A) or electromechanical (e.g., sensors). 
     The movable opening cover  62  can be made from any suitable material including a polymer (e.g., polyimide). The movable opening cover  62  can have various shapes/configurations to allow for different combinations of coverage of the openings  44 A on the movable manifold  38 A. In the embodiment shown in  FIG. 4A , the movable opening cover  62  has a triangular portion to allow for covering one of the openings  44 A. The shape of the movable opening cover  62  also allows for two or more (e.g., 10%, 20%, 25%, 30%, 33%, 40%, 50%, 60%, 66%, etc.) of the openings  44 A to be covered. When the openings  44 A are covered by the movable opening cover, the flow of fluid/gas through that blocked opening  44 A is interrupted/stopped. This allows for control of the directionality of the flow of fluid/gas into the balloon  36 A. 
     In addition to the movable opening cover  62  being movable longitudinally and rotationally, the movable manifold  38 A can also be movable as described herein (e.g., see the movable manifold  38  in  FIGS. 2A-B  and related description). In this embodiment, the movable manifold  38 A can be moved independently of the movable opening cover  62 . For example, the movable manifold  38 A can be translated longitudinally and/or rotated about the longitudinal axis of the central lumen  40 A and the movable opening cover  62  can separately be translated longitudinally and/or rotated about the longitudinal axis of the central lumen  40 A. The manifold and the movable opening cover can have separate mechanisms (e.g., separate pull/activation wires, control elements, knobs, levels, handles, etc.) for controlling movement from a proximal location of the elongate medical device (e.g., at the handle  20  of  FIG. 1 ) or the control mechanisms can be combined (e.g., the longitudinal movement of the movable opening cover  62  and the movable manifold  38 A can be coordinated/coupled). 
     The openings  44 A can be located at various locations along the movable manifold  38 A. For example, the openings  44 A can be at a location that is proximate a manifold distal end (e.g., the manifold distal end  48  of  FIGS. 2A-B ). In some embodiments, the openings  44 A can be located alternatively and/or additionally at a location between a manifold proximal end (e.g., the manifold proximal end  46  of  FIGS. 2A-B ) and the manifold distal end. The openings  44 A can vary in different ways (e.g., location, number, size, shape, etc.) to allow for variation in treatment of the fluid such as different directions, angles, flow patterns, flow rates, etc. In some embodiments, the openings  44 A can include, for example, a nozzle, orifice, or other suitable element to control and/or direct the flow of the fluid as it out of the movable manifold  38 A and into the balloon  36 A. For example, the nozzle, orifice, or other element can be a separate element or integral to the movable manifold  38 A. 
     The central lumen  40 A can provide fluid, medical devices that include any suitable sensor, wire (e.g., a guide wire), device, and/or other items commonly used in elongate medical device procedures. For example, the central lumen  40 A can include a central opening, a hollow tube, and/or a tubular port. In some embodiments, the central lumen  40 A can include more than one separate lumen which could include a lumen offset from the center of and/or separate the central lumen  40 A. 
     The balloon  36 A can be configured to occlude an opening in a body (e.g., a pulmonary vein in the heart or other opening in the body). When the balloon  36 A is occluding the opening, a portion of the balloon  36 A is in contact with tissue (e.g., a therapy site). The portion of the balloon  36 A in contact with the tissue can facilitate therapy of the tissue (e.g., the creation of ablation lesions in, for example, the pulmonary vein (PV) or other locations in the body). 
     Similar to the description above for  FIGS. 2A-B , the movable manifold  38 A can be made from any suitable material (e.g., a metal, polymer, etc.) and can be coupled with, for example, the central lumen. The movable manifold  38 A can be in any suitable configuration regarding a longitudinal length and wall thicknesses of the movable manifold  38 A. 
     The contents of the balloon  36 A (e.g., a fluid or a gas) can be cooled by any suitable means including, expansion of a liquid to a gas. The fluid/gas can then lower the temperature of the balloon  36 A and then the tissue adjacent the balloon  36 A. Specific portions of the balloon  36 A can be targeted (or blocked) as described herein for therapy (or protection from therapy) to specific tissue portions. 
     In some embodiments (not shown), the central lumen  40 A can be coupled with a manifold that is not movable (a fixed manifold). Similar to the embodiments described herein, the fixed manifold can include openings  44 A in various patterns and arrangements. The movable opening cover  62  can be moved longitudinally and/or rotated to cover various openings  44 A to block the flow of the fluid/gas. 
     The embodiments described herein can be applied to other balloon structures. For example, U.S. Pat. No. 8,052,680, issued on 8 Nov. 2011, and assigned to St. Jude Medical, Atrial Fibrillation Division, Inc. (the &#39;680 patent), includes processes and devices for the treatment of atrial arrhythmia. A catheter and an introducer similar to embodiments described herein could be used with a balloon described in the &#39;680 patent. The &#39;680 patent is hereby incorporated by reference in its entirety as though fully set forth herein. 
       FIG. 4B  is a partial fragmentary view of the distal end of the elongate medical device coupled with the balloon with the movable manifold and the port block tube of  FIG. 4A , where the movable opening cover is rotated to block a second opening, consistent with embodiments in the present disclosure. The balloon apparatus  30 A can include the elongate medical device  32 A, which can include the balloon  36 A coupled to the distal end portion of the elongate medical device  32 A, where the balloon  36 A can include a movable manifold  38 A and a central lumen  40 A. The movable manifold  38 A can include a movable manifold proximal end (e.g., proximal end  46  in  FIGS. 2A-B ) and a movable manifold distal end (e.g., distal end  48  in  FIGS. 2A-B ), with the openings  44 A on the movable manifold  38 A 
     In the embodiment of  FIG. 4B , the openings  44 A are shown being proximate the movable manifold distal end. In other embodiments the openings  44  can be located at any suitable location between the movable manifold proximal end and/or the movable manifold distal end. In still further embodiments, additional openings  44 A can be located at various locations along the movable manifold  38 A between the movable manifold proximal end and the movable manifold distal end. The additional openings  44 A can allow for variations in the flow of the fluid as it flows from the movable manifold  38 A into the balloon  36 A. 
       FIG. 5  is a partial fragmentary view of a distal end of an elongate medical device with a balloon with a movable manifold and a pressure sensor, consistent with embodiments in the present disclosure.  FIG. 5A  shows an exemplary configuration of an elongate medical device  32 B a central lumen  40 B, a supply lumen  42 A, and a movable manifold  38 B (similar to the elongate medical device  32  shown in  FIGS. 2A-B  and described above) plus a pressure sensor  64 . As described herein, the supply lumen  42 A can be used to supply a fluid to the balloon  36 B through the movable manifold  38 B. The central lumen  40 B can also be used with, for example, a guide wire to maneuver the elongate medical device  32 B to a location in the body  14  ( FIG. 1 ). The pressure sensor  64  can be, for example, a MEMS sensor that can determine a pressure inside the balloon  36 B. The pressure inside the balloon  36 B can vary during therapy. In some instances, a leak or a problem with the rate of flow (e.g., a kink in a line from the fluid supply  16  of  FIG. 1 ) of a gas/fluid into the balloon  36 B can be indicated by data provided by the pressure sensor  64  (e.g., maximum and/or minimum pressure, rate of change of pressure, etc.). 
     For example, if the pressure determined by the pressure sensor  64  rapidly increases, this could represent a failure of a part of the balloon apparatus  30 B, which could lead to the balloon  36 B overfilling with the fluid/gas which could lead to balloon failure. The data from the pressure sensor  64  could allow a user or an automated control system (e.g., an electronic control unit that can be part of the energy/fluid supply  16  of  FIG. 1 ) to turn off the flow of gas/fluid into the balloon  36 B to prevent failure of the balloon  36 B. As shown in  FIG. 5A , the pressure sensor  64  can be electrically connected by a wire  66  to, for example, the energy/fluid supply  16  of  FIG. 1  and/or an electronic control unit. 
     The pressure sensor  64  can be coupled with the central lumen  40 B at any suitable location inside the balloon  36 B. The pressure sensor  64  can be positioned to permit movement of the movable manifold  38 B. For example, the pressure sensor  64  can be embedded into an outer wall surface of the central lumen  40 B (e.g., the pressure sensor  64  is flush with the outer wall of the central lumen  40 B). In another embodiment (not shown), if the pressure sensor  64  is not flush with the outer wall of the central lumen  40 B, the movable manifold can be configured to pass over the pressure sensor while moving longitudinally along the central lumen  40 B. 
     As discussed above, the pressure sensor  64  can be electrically connected by a wire  66  to, for example, the energy/fluid supply  16  of  FIG. 1  and/or an electronic control unit. The pressure sensor  64  can be any suitable type of pressure sensor, including a MEMS sensor, a fiber optic sensor, a strain gauge, or other sensors that can determine a pressure inside the balloon  36 B. The pressure inside the balloon  36 B can vary during therapy and the pressure sensor  64  can provide feedback regarding changes in the pressure of the fluid/gas inside the balloon  36 B (e.g., monitor the increase in pressure as the fluid/gas is added to the balloon  36 B, monitor for decreases in pressure that may be caused by leaks or other issues, etc.). 
     The elongate medical device  32  can be connected with, for example, a processor and a memory storing non-transitory computer-readable instructions, as discussed herein (e.g., as part of the ECU, or a separate processor and a separate memory, or a combination of the two). The ECU may be programmed with a computer program (e.g., software) encoded on a computer-readable storage medium for assessing the pressure inside the balloon  36 B and changes to the pressure. The instructions can be executable to compute, for example, the rates of change of pressure in the balloon  36 B, limits on maximum and minimum pressure in the balloon  36 B, flow rates of the fluid/gas into (and out of the balloon  36 B, and/or other related characteristics. 
     It should be understood that the system (e.g., system  10  of  FIG. 1 ) may include a conventional processing apparatus known in the art, capable of executing pre-programmed instructions stored in an associated memory, all performing in accordance with the functionality described herein. It is contemplated that the methods described herein, including without limitation the method steps of embodiments of the disclosure, will be programmed in a preferred embodiment, with the resulting software being stored in an associated memory and where so described, may also constitute the means for performing such methods. Implementation of the embodiments, in software, in view of the foregoing enabling description, would require no more than routine application of programming skills by one of ordinary skill in the art. Such a system may further be of the type having both ROM and RAM, a combination of non-volatile and volatile (modifiable) memory so that the software can be stored and yet allow storage and processing of dynamically produced data and/or signals. 
     Additional information and examples can be found in U.S. application no. 62/506,853, filed on 16 May 2017, U.S. application Ser No. ______. (attorney docket number 065513-001658, filed concurrently), U.S. application Ser No. ______. (attorney docket number 065513-001661, filed concurrently), and U.S. application Ser No. ______. (attorney docket number 065513-001662, filed concurrently), each of which is hereby incorporated by reference as if set forth fully herein. 
     Although at least one embodiment of a cryo-therapy balloon has been described above with a certain degree of particularity, those skilled in the art could make numerous alterations to the disclosed embodiments without departing from the spirit or scope of this disclosure. All directional references (e.g., upper, lower, upward, downward, left, right, leftward, rightward, top, bottom, above, below, vertical, horizontal, clockwise, and counterclockwise) are only used for identification purposes to aid the reader&#39;s understanding of the present disclosure, and do not create limitations, particularly as to the position, orientation, or use of the disclosure. Joinder references (e.g., attached, coupled, connected, and the like) are to be construed broadly and can include intermediate members between a connection of elements and relative movement between elements. As such, joinder references do not necessarily infer that two elements are directly connected and in fixed relation to each other. It is intended that all matter contained in the above description or shown in the accompanying drawings shall be interpreted as illustrative only and not limiting. Changes in detail or structure can be made without departing from the spirit of the disclosure as defined in the appended claims. 
     Various embodiments are described herein to various apparatuses, systems, and/or methods. Numerous specific details are set forth to provide a thorough understanding of the overall structure, function, manufacture, and use of the embodiments as described in the specification and illustrated in the accompanying drawings. It will be understood by those skilled in the art, however, that the embodiments may be practiced without such specific details. In other instances, well-known operations, components, and elements have not been described in detail so as not to obscure the embodiments described in the specification. Those of ordinary skill in the art will understand that the embodiments described and illustrated herein are non-limiting examples, and thus it can be appreciated that the specific structural and functional details disclosed herein may be representative and do not necessarily limit the scope of the embodiments, the scope of which is defined solely by the appended claims. 
     Reference throughout the specification to “various embodiments,” “some embodiments,” “one embodiment,” or “an embodiment”, or the like, means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, appearances of the phrases “in various embodiments,” “in some embodiments,” “in one embodiment,” or “in an embodiment”, or the like, in places throughout the specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments. Thus, the particular features, structures, or characteristics illustrated or described in connection with one embodiment may be combined, in whole or in part, with the features structures, or characteristics of one or more other embodiments without limitation given that such combination is not illogical or non-functional. 
     It will be appreciated that the terms “proximal” and “distal” may be used throughout the specification with reference to a clinician manipulating one end of an instrument used to treat a patient. The term “proximal” refers to the portion of the instrument closest to the clinician and the term “distal” refers to the portion located furthest from the clinician. It will be further appreciated that for conciseness and clarity, spatial terms such as “vertical,” “horizontal,” “up,” and “down” may be used herein with respect to the illustrated embodiments. However, surgical instruments may be used in many orientations and positions, and these terms are not intended to be limiting and absolute. 
     Any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated materials do not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.