Patent Publication Number: US-2021162185-A1

Title: Medical delivery device and method of use

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims the benefit of priority from U.S. Provisional Application No. 62/942,925, filed on Dec. 3, 2019, which is incorporated by reference herein in its entirety. 
    
    
     TECHNICAL FIELD 
     The present disclosure relates generally to endoscopic medical devices and related methods of use. More particularly, in some embodiments, the disclosure relates to endoscopic medical tools and methods related to accessing target sites and dispensing materials to the target sites. 
     BACKGROUND 
     In certain medical procedures, it may be necessary to stop or minimize bleeding and/or supply therapeutic materials internal to the body. For example, an endoscopic medical procedure may require hemostasis of bleeding tissue within the gastrointestinal tract, for example in the esophagus, stomach, or intestines. 
     During an endoscopic procedure, a user inserts a sheath of an endoscope into a body lumen of a patient. The user utilizes a handle of the endoscope to control the endoscope during the procedure. Tools are passed through a working channel of the endoscope via, for example, a port in the handle, to deliver treatment at the procedure site near a distal end of the endoscope. The procedure site is remote from the operator. 
     To achieve hemostasis at the remote site and/or promote natural tissue healing, a hemostatic or regenerative agent or tissue adhesive may be delivered by a device inserted into the working channel of the endoscope. Agent/adhesive delivery may be achieved through mechanical systems, for example. Such systems, however, may not achieve a desired rate of agent delivery or a desired dosage of agent, may result in inconsistent dosing of agent, or may not result in the agent reaching the treatment site deep within the GI tract. The current disclosure may solve one or more of these issues or other issues in the art. 
     SUMMARY OF THE DISCLOSURE 
     According to an aspect, a medical device includes a sheath having a proximal end, a distal end, and at least one lumen extending from the proximal end to the distal end, and a balloon at the distal end of the sheath and having an inflated configuration and a deflated configuration. The balloon defines at least one space radially inward of an exterior surface of the balloon, the at least one space configured to retain a material, and the transition of the balloon from the deflated configuration to the inflated configuration delivers the material from the at least one space to a target site in a body. 
     The at least one lumen may include a sheath lumen, wherein the medical device may be configured to be attached to a fluid containment device, and wherein a fluid from the fluid containment device may be configured to be supplied to the sheath lumen to transition the balloon from the deflated configuration to the inflated configuration. 
     The at least one lumen ma include a delivery lumen defined by an outer wall of the balloon and an inner wall of the balloon, wherein the at least one space may include channels extending from respective openings in the outer wall and fluidly coupled to the delivery lumen, and wherein the delivery lumen may be fluidly decoupled from the sheath lumen. 
     The at least one space may include a balloon lumen disposed between an inner wall and an outer wall of the balloon, and wherein the balloon may include a plurality of openings in the outer wall of the balloon fluidly coupled to the balloon lumen. 
     Transition of the balloon from the deflated configuration to the inflated configuration may open the plurality of openings. 
     The balloon lumen and the sheath lumen may be separated by the inner wall, wherein the inner wall may include openings, and wherein transition of the balloon from the deflated configuration to the inflated configuration may open the openings in the inner wall to fluidly couple the sheath lumen to the balloon lumen. 
     The material may be configured to be disposed within the balloon lumen, and wherein transition of the balloon from the deflated configuration to the inflated configuration may cause the fluid to flow through the openings in the inner wall and mix with the material, and may deliver the material from the balloon lumen to the target site. 
     The plurality of openings in the outer wall of the balloon may be sealed in the deflated configuration by a perforated membrane. 
     The balloon may include folds in at least the deflated configuration, and the at least one space may be at least partially defined by the folds, and wherein at least one delineation of each of the folds may decrease in the inflated configuration to expose the at least one space to an external environment. 
     The at least one lumen may include an outer lumen disposed about the sheath lumen, wherein the outer lumen may extend from the proximal end of the sheath and terminates proximal of the balloon, and wherein an outer wall of the sheath may include sheath openings adjacent the balloon and fluidly coupled to the outer lumen. 
     The balloon may not include an outer coating of the material in the deflated configuration. 
     The at least one space may include channels extending from an outer surface of the balloon toward a central longitudinal axis of the balloon, and wherein each of the channels may include an opening at an outer surface of the balloon. 
     The material may be disposed within the channels in the deflated configuration, wherein each of the openings may be closed from an external environment in the deflated configuration to retain the material, and wherein transition from the deflated configuration to the inflated configuration may release the material from each of the channels through the openings. 
     The at least one lumen may include a delivery lumen defined by an outer wall of the balloon and an inner wall of the balloon, wherein the at least one space may include channels extending from an outer surface of the balloon toward a central longitudinal axis of the balloon, wherein each of the channels may include an opening at an outer surface of the balloon, and wherein the channels and the openings may be fluidly coupled to the delivery lumen. 
     A proximal end of the delivery lumen may be configured to be attached to a device containing the material, wherein the material may be configured to be delivered to a target site via the second lumen and the openings, and wherein the delivery lumen may be fluidly decoupled from any other lumen from the at least one lumen. 
     According to another aspect, a medical device includes a sheath having a proximal end, a distal end, and at least one lumen extending from the proximal end to the distal end, a balloon at the distal end of the sheath and having an inflated configuration and a deflated configuration, and a patch disposed on the balloon, wherein a material is provided on a first surface of the patch opposite a second surface of the patch facing the balloon, and wherein the material is configured to be delivered to a target site. 
     The patch may include an adhesive on the second surface of the patch which may be configured to maintain a position of the patch relative to the balloon, wherein a fluid may be configured to be supplied to the balloon via the at least one lumen to inflate the balloon to the inflated configuration, and wherein the fluid may be configured to change a temperature of the balloon to overcome an adhesion force of the adhesive between the patch and the balloon. 
     The at least one lumen may include a sheath lumen configured to receive a first fluid to inflate the balloon from the deflated configuration to the inflated configuration, and an outer lumen disposed about the sheath lumen, wherein the outer lumen may extend from the proximal end of the sheath and may terminate proximal of the balloon, wherein an outer surface of the sheath may include openings fluidly coupled to the outer lumen, and wherein a second fluid may be configured to be delivered to the second surface of the patch via the openings to overcome an adhesion force of the adhesive between the patch and the balloon. 
     According to yet another aspect, a method of performing a medical procedure includes positioning a sheath adjacent a target site within a body, supplying a fluid to a sheath lumen of the sheath to transition a balloon at the distal end of the sheath from a deflated configuration to an inflated configuration, supplying a material from the balloon to the target site as the balloon transitions from the deflated configuration to the inflated configuration from at least one space radially inward of an exterior surface of the balloon, and withdrawing the fluid from the sheath lumen to collapse the balloon from the inflated configuration to the deflated configuration. 
     The method may further include delivering a second fluid to the target site via an outer lumen about the sheath lumen, wherein the second fluid is configured to activate the material such that the material adheres to the target site. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate various exemplary embodiments and together with the description, serve to explain the principles of the disclosed embodiments. 
         FIG. 1  is a perspective view of a medical system according to an embodiment; 
         FIG. 2A  is a perspective view of a distal end of a medical tool of the medical system of  FIG. 1 , according to an embodiment; 
         FIG. 2B  is a cross-section taken along the line  2 - 2  of  FIG. 2A ; 
         FIG. 3A  is a perspective view of a distal end of another medical tool of the medical system of  FIG. 1 , according to an embodiment; 
         FIG. 3B  is a cross-section taken along the line  3 - 3  of  FIG. 3A ; 
         FIGS. 4A-4C  are perspective views of a distal end of a medical tool of the medical system of  FIG. 1 , according to another embodiment; 
         FIGS. 5A and 5B  are perspective views of a distal end of a medical tool of the medical system of  FIG. 1 , according to another embodiment; 
         FIGS. 6A and 6B  are perspective views of a distal end of a medical tool of the medical system of  FIG. 1 , according to another embodiment; and 
         FIGS. 7A and 7B  are perspective views of a distal end of a medical tool of the medical system of  FIG. 1 , according to yet another embodiment. 
     
    
    
     DETAILED DESCRIPTION 
     The present disclosure is now described with reference to an exemplary medical system that may be used to dispense materials endoscopically. However, it should be noted that reference to this particular procedure is provided only for convenience and not intended to limit the disclosure. A person of ordinary skill in the art would recognize that the concepts underlying the disclosed devices and application methods may be utilized in any suitable procedure, medical or otherwise. The present disclosure may be understood with reference to the following description and the appended drawings, wherein like elements are referred to with the same reference numerals. 
     For ease of description, the term “distal” refers to a portion farthest away from a user when introducing the system into a patient. By contrast, the term “proximal” refers to a portion closest to the user when introducing the system into the patient. As used herein, the terms “comprises,” “comprising,” or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not necessarily include only those elements, but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. The term “exemplary” is used in the sense of “example,” rather than “ideal.” In this disclosure, relative terms, such as, for example, “about,” “substantially,” “generally,” and “approximately” are used to indicate a possible variation of ±10% in a stated value or characteristic. 
     Referring to  FIG. 1 , a medical system  10  according to an embodiment is shown. Medical system  10  includes a flexible shaft  20  (e.g., a catheter) and a handle  40  connected at a proximal end of flexible shaft  20 . Handle  40 , or some other device for actuating or controlling medical system  10  and any tool or devices associated with medical system  10 , includes first and second actuating devices  42 ,  43 . Devices  42 ,  43  control articulation of flexible shaft  20  and/or an articulation joint at a distal end of flexible shaft  20 , in multiple directions. Devices  42 ,  43 , may be, for example, rotatable knobs that rotate about their axes to push/pull actuating elements (not shown). The actuating elements, such as cables or wires suitable for medical procedures (e.g., medical grade plastic or metal), extend distally from a proximal end of endoscope  10  and connect to flexible shaft  20  to control movement thereof. Alternatively, or additionally, a user may operate actuating elements independently of handle  40 . Distal ends of actuating elements extend through flexible shaft  20  and terminate at an articulation joint and/or a distal tip of flexible shaft  20 . For example, one or more actuating elements may be connected to an articulation joint, and actuation of actuating elements may control the articulation joint or the distal end of flexible shaft  20  to move in multiple directions. 
     In addition, one or more electrical cables (not shown) may extend from the proximal end of endoscope  10  to the distal end of flexible shaft  20  and may provide electrical controls to imaging, lighting, and/or other electrical devices at the distal end of flexible shaft  20 , and may carry imaging signals from the distal end of flexible shaft  20  proximally to be processed and/or displayed on a display. Handle  40  may also include ports  44 ,  46  for introducing and/or removing tools, fluids, or other materials from the patient. Port  44  may be used to introduce tools. Port  46  may be connected to an umbilicus for introducing fluid, suction, and/or wiring for electronic components. For example, as shown in  FIG. 1 , port  44  is connected to a lumen  22 , which extends from the proximal end to the distal end of flexible shaft  20 . Port  44  may receive a medical device, such as flexible sheath  120  (e.g., a catheter) of a medical device. 
     As shown in  FIG. 1 , sheath  120  may include a lumen  122  extending therethrough, from a proximal end to a distal end of sheath  120 . Sheath  120  may incorporate, or otherwise be attached to, a distal end of an actuating device  140 . Actuating device  140  is a Y-shaped member having a first channel  123  having a first opening  123   a  and a second channel  124  having a second opening  124   a . As will be explained herein, first and second channels  123 ,  124  may communicate with lumen  122  and may be used for inflating or deflating a balloon  130  at a distal end of sheath  120 . For example, attaching first channel  123  to a containment device (not shown) having a fluid F, and supplying fluid F (shown, e.g., by an arrow in  FIG. 2A ) to first channel  123  may inflate balloon  130 , while attaching second channel  124  to the container may withdraw fluid F from balloon  130  and into the containment device, thereby deflating balloon  130 . It will be understood that actuating device  140  is not limited to two channels. For example, additional channels may be included in actuating device  140  to provide additional fluid and/or materials to a distal end of sheath  120 , as will be described herein. As a further example, actuating device  140  may include only a single channel for selectively introducing or removing materials, including fluids, to or from lumen  122 . 
     Referring to  FIGS. 1, 2A, and 3A , catheter  20  includes a plurality of lumens, e.g., a first lumen  22 , a second lumen (for ease of description, second lumen is not shown, but extends from a proximal end of catheter  20  to an opening  24   a  shown in  FIG. 1 ), and a third lumen  26  extending from a proximal end of catheter  20  to an opening  26   a . According to an example, first lumen  22  is configured to receive sheath  120  of the medical device, as will be described in greater detail herein. First lumen  22  extends from handle  40  and terminates at a first opening  22   a  at a distal end face  28  of catheter  20 . The second lumen and third lumen  26  may receive additional tools, and/or may be used for suction/vacuum, dispensing fluid, imaging, illumination, or the like. For example, distal openings  24   a ,  26   a  of the second lumen and third lumen  26  may be open at distal end face  28  of catheter  20 . According to an example, fluid may be expelled through one or both of openings  24   a ,  26   a  after traveling along the respective second lumen and third lumen  26  from handle  40 . Alternatively, debris may be suctioned/vacuumed through one or both of openings  24   a ,  26   a , and/or an electrical fiber may be disposed in one or both of the second lumen and third lumen  26  and attached to a visualization component, such as a camera, or an illumination member, such as a light emitting diode (LED), disposed at openings  24   a ,  26   a . It will be understood that these components may be fixed in openings  24   a ,  26   a , or the components may be extended from distal end face  28  to provide additional illumination of and/or visualization of a target site T. For ease of description, catheter  20  is shown only in  FIGS. 1, 2A, and 3A . However, it will be understood that any medical tool described herein may access target site T by being passed through lumen  22  of catheter  20 . 
     With continued reference to  FIG. 1 , sheath  120  extends within first lumen  22  of catheter  20 . Sheath  120  is flexible and has an outer diameter less than an inner diameter of first lumen  22 , thereby allowing sheath  120  to slide within and along first lumen  22 . Sheath  120  includes an inflatable balloon  130  at a distalmost end. Balloon  130  is actuatable between an open, inflated position and a closed, deflated position using an inflation fluid, e.g., a liquid, such as saline, or a gas, such as CO 2 . As will be described herein, balloon  130  is capable of being inflated adjacent target site T and distal of a distalmost end of catheter  20 , thereby enabling a material, such as a hemostatic or regenerative agent, to be supplied to target site T. 
       FIG. 2A  illustrates catheter  20  disposed in lumen L of a body and adjacent target site T. Sheath  120  is advanced along first lumen  22  by, e.g., pushing on a proximal end of sheath  120 , to expose balloon  130  from distal end face  28  of catheter  20 . For example, a user may insert balloon  130  into port  44  at handle  40  and advance balloon  130  along lumen  22  by pushing on sheath  120 . This movement causes balloon  130  to be exposed from first opening  22   a . As described herein, openings  24   a ,  26   a  may include lighting and/or visualization elements, which may assist in positioning balloon  130 . 
     As shown in  FIGS. 2A and 2B , target site T protrudes into lumen L. As discussed above, catheter  20  may include actuating elements, e.g., cables, extending from handle  40 , to the distal end of catheter  20 . Pulling on those cables can bend the end of catheter  20 , as necessary, to properly position balloon  130  adjacent target site T. Alternatively, or additionally, a guidewire (not shown) may be advanced adjacent target site T. Sheath  120  may include a central lumen (not shown), and sheath  120  may be advanced along the guidewire. 
     With continued reference to  FIG. 2A , balloon  130  is in a deflated configuration, distal of distal end face  28  of catheter  20  and adjacent target site T. Sheath  120  includes a distal tip  132 , and balloon  130  is positioned proximally of distal tip  132 . With reference to  FIG. 2B , a cross-section along the line  2 - 2  in  FIG. 2A  illustrates that balloon  130  has a body  134  that is folded. As will be explained herein, balloon  130  inflates from the deflated configuration by supplying fluid F to balloon  130  via lumen  122 . 
     As further shown in  FIG. 2B , body  134  includes folds  135  that create pockets or spaces  136  between adjacent folds  135  in the deflated configuration. Pockets  136  contain material, e.g., a hemostatic or a regenerative agent, that is supplied to target site T, as will be described herein. Balloon  130  may be compliant or non-compliant, and may include any number of folds  135 . Each fold  35  may overlie a portion of an adjacent fold  135 , to create pockets  136 . In other embodiments, adjacent folds  135  do not overlie one another. Each fold  135  also is radially outward of portion of the outer surface of balloon  135  so that they are not part of folds  135 , to also create pockets  136 . In some examples, folds  135  are the radially outermost portion of balloon  130 , e.g., in some examples there is no covering over folds  135  and/or the outermost surface balloon  130 . Folds  135  may create pockets  136  for an agent and may extend fully around a circumference of the balloon  130 , although in some embodiments, folds  135  may be on only a portion of balloon  130 , e.g., folds  135  may only extend partially around the circumference of balloon  130  to target a desired area of tissue for treatment. In some embodiments, different agents may be disposed in different folds  135  around different portions of the balloon  130 . For example, some of folds  135  may contain an inactive agent and other folds  135  may contain a catalyst, and the catalyst may activate the inactive agent when balloon  130  is expanded and the inactive agent and the catalyst come into contact. Alternatively, or additionally, various agents may degrade or otherwise become ineffective if exposed to other agents for an extended period of time. Disposing different agents in different folds  135  may improve the lifetime of these agents and may improve the effectiveness of the agents once deployed at target site T. 
     With reference to  FIGS. 3A and 3B  (which shows a cross-section of balloon  130  along the line  3 - 3  of  FIG. 3A ), balloon  130  is shown in the inflated position. According to an example, balloon  130  may be inflated by supplying fluid F, e.g., a gas or a liquid, to lumen  122  of sheath  120  via actuation mechanism  140 . For example, one of the first or second channels  123 ,  124  may be connected to a containment device storing fluid F. Fluid F may travel along lumen  122  and fill balloon  130 , causing balloon  130  to inflate. In the inflated or expanded position, body  134  of balloon  130  forms a cylindrical or rounded shape and folds  135  of body  134  and corresponding pockets  136  (see  FIG. 2A ) partially or completely disappear, exposing the material to target site T (see  FIGS. 3A and 3B ). During and upon inflation or expansion, the material underlying folds  135  in pockets  136  is released. As shown in  FIG. 3A , balloon  130  approaches or abuts against target site T, allowing the material to be transferred to target site T. After the material has been transferred to target site T, balloon  130  is deflated. 
     An operation of balloon  130  will now be described. 
     Catheter  20  is inserted into a body through a natural orifice or an incision in a patient. Catheter  20  is advanced along a body lumen to target site T. Once catheter  20  is positioned adjacent target site T, sheath  120  is inserted into port  44  and advanced along first lumen  22 . It will be understood that sheath  120  may be inserted into port  44  prior to the beginning of the procedure, e.g., before inserting catheter  20  into the body, and sheath  120  may be advanced to target site T at a same time as catheter  20 . 
     After positioning catheter  20  and sheath  120  adjacent target site T, a proximal end of sheath  120  is manipulated to move sheath  120  along first lumen  22  in a distal direction with respect to catheter  20 . Moving sheath  120  in the distal direction forces balloon  130  toward a distal end of catheter  20  and out first opening  22   a  in distal end face  28 , thereby positioning balloon  130  adjacent target site T. 
     After balloon  130  is positioned outside first lumen  22  and adjacent target site T, balloon  130  is inflated. According to an example, inflating balloon  130  includes attaching one of first or second channels  123 ,  124  to a fluid containment device and supplying fluid F to lumen  122 . Fluid F travels along lumen  122  of sheath  120  to balloon  130 . As balloon  130  fills with fluid F, body  134  of balloon  130  inflates or expands, releasing the material within pockets  136  of folds  135 . Further inflation or expansion of body  134  forces body  134  toward and against target site T, further causing folds  135  in body  134  to smooth out and press the material against target site T. Fluid F can remain in balloon  130  for a time period, e.g., approximately 10 minutes or less, or approximately one minute or less, sufficient to transfer the material to target site T. This time period may depend on a material of balloon  130  and/or fluid F and an interaction with target site T, and/or a preference of the physician performing the medical procedure. Additionally, the time period may be changed based on when an opening at target site T is closed. According to an example, abutting balloon  130  against target site T and applying pressure to the material may seal a bleed/cut or otherwise close a tear or opening at target site T. 
     Once the material is sufficiently transferred to target site T or target site T is otherwise treated, balloon  130  is deflated by removing fluid F. For example, to remove fluid F, the other of first or second channels  123 ,  124  is attached to the fluid containment device and fluid moves, via a syringe or pump operated by a user or an electrically operated pump associated with the fluid containment device, from balloon  130 , along the lumen of sheath  120 , and into the fluid containment device. Removing fluid F from balloon  130  causes balloon  130  to collapse on itself, and balloon  130  can be removed from the body, e.g., by moving sheath  120  proximally to move balloon  130  into lumen  22  of catheter  20 . Alternatively, or additionally, balloon  130  may be moved along a guidewire to remove balloon  130  from the body. 
     A balloon  230  according to another example is shown in  FIGS. 4A-4C . While not shown, balloon  230  may be introduced into a body using a catheter and/or a guidewire, as explained herein. Balloon  230  is proximal of a distal tip  232  of sheath  120 , and includes flexible channels  234  that are preloaded with a material, such as a therapeutic or regenerative material described herein. Channels  234  are bounded on sides by exterior surfaces  224   a  of a body  224  of balloon  230 . A radially inner portion of each channel  234  is bounded by an outer surface of sheath  120  (or a surface of balloon  130  fixed to the outer surface of sheath  130 ). A radially outer portion of each channel  234  defines a channel opening  234   a . When balloon  230  is in a deflated orientation, as shown in  FIG. 4A , portion of body  224  of balloon  230  overlap channel opening  234   a  of each of channel  234 , containing the material generally to channels  234 , although some weeping of material from channels  234  may occur. As balloon  230  is inflated from a deflated configuration by supplying fluid F to balloon  230  via lumen  222 , as shown in  FIG. 4B , channel openings  234   a  open (expose to the body lumen), since the portions of body  234  covering channel openings  234   a  move away from channel openings  234   a . This allows the material to flow to target site T from channels  234  via channel openings  234   a , as shown by arrows R. For example, fluid F may be supplied along lumen  222  to an opening  160  in lumen  222 , e.g., at a distal end thereof, and fluid F may be supplied to balloon  230  via opening  160 , thereby causing balloon  230  to inflate. It will be understood that channel openings  234   a  may be closed in the deflated configuration by any other structure, e.g., a perforated wall of balloon  230  which may rupture once balloon  230  is sufficiently inflated. Perforations or other similar closure mechanisms may be similarly used to selectively close openings described herein. 
       FIG. 4C  shows balloon  230  in a fully inflated configuration, in which the material has been completely or almost completely expelled from channels  234 . According to an example, exterior surface  224   a  that define each of channels  234  may abut each other when in the fully inflated configuration, which aids in expelling a maximum amount of material from each of channels  234 . Balloon  230  does not contact target tissue T in  FIGS. 4B and 4C . However, it will be understood that balloon  230  may contact and press against target tissue T. 
     According to an embodiment, channels  234  are generally cylindrical and have a longitudinal axis (at least when inflated) transverse to, and in comes case, generally perpendicular to, a longitudinal axis of sheath  120 . However, the orientation and the shape of channels  234  is not limited thereto, and channels  234  may be any orientation, e.g., angled relative to the longitudinal axis, and any shape, e.g., conical, columnar, or cuboidal, sufficient for storing the material and for transferring the material to target site T. Moreover, the number and/or the arrangement of channels  234  is not limited. For example, channels  234  may be equally or randomly spaced along balloon  230 . In some examples, an additional curing agent may be supplied along a lumen of sheath  120 , separate from lumen  222 , and into channels  234 , as will be described herein. In other examples, some channels  234  may include a first agent while other while other channels  234  include a second agent, e.g., a curing agent. 
     An operation of balloon  230  will now be described. Balloon  230  is inserted into the body and advanced to target site T in any manner described herein. Once balloon  230  is adjacent target site T, balloon  230  is inflated in any manner described herein, e.g., by supplying fluid F along lumen  222  to an opening in lumen  222 . Since opening  160  is in fluid communication with the balloon  230 , balloon  230  begins to inflate, causing body  224  to move and unblock channel openings  234   a . As channel openings  234   a  are covered to open, the material stored in channels  234  is exposed to target site T. The material may be forced from channels  234  via channel openings  234   a  by a pressure of balloon  230  expanding toward channels  234 . As balloon  230  continues to inflate, the material continues to be expelled. Once balloon  130  is fully inflated, surfaces  224   a  that define each of channels  234  may contact each other, which may assist the material from being expelled from channels  234 . After the material has sufficiently coated target site T, balloon  230  is deflated and may be removed from the body, in any manner described herein. 
     A balloon  330  according to another embodiment is shown in  FIGS. 5A and 5B . While not shown, balloon  330  may be introduced into a body using a catheter and/or a guidewire, as explained herein. Balloon  330  is proximal of a distal tip  332  of sheath  320 . Sheath  320  includes a first lumen  322  and a second lumen  324 , each of which extends from a proximal end of sheath  320  to balloon  330 . First lumen  322  receives fluid F from a fluid containment device, as described herein, to inflate balloon  330 , as described herein. First lumen  322  also is used for deflation of balloon  330 , as described herein. Second lumen  324  is connected to a balloon lumen  334  and receives a material and/or other fluids, e.g., a reagent, an adhesive, air, and/or water, to be supplied to target site T via openings  334   a  in an exterior surface of balloon  330 . Openings  334   a  are fluidly connected to second lumen  324  via balloon lumen  334 . As shown in  FIGS. 5A and 5B , balloon lumen  334  is defined by an outer wall  334   b  of balloon  330  and an inner wall  322   a  of balloon  330 , and balloon lumen  334  is fluidly decoupled from lumen  322  via inner wall  322   a . Balloon lumen  334  therefore may be an annular ring-like space or cavity that completely surrounds an inner portion of balloon  330  that receives fluid F. In other embodiments, balloon lumen  334  may only partially surround that inner portion of balloon  330 . 
     According to an example, the material may be preloaded in second lumen  324 , and the material may exit openings  334   a  in outer wall  334   b  due to a pressure on balloon  330  when balloon  330  inflates. Additionally, or alternatively, a fluid may be supplied along second lumen  324  to force the material through openings  334   a  and/or by mixing with the material and forcing the mixture from openings  334   a . According to another example, the material may be supplied to second lumen  324  after balloon  330  is inflated, e.g., by supplying the material to second lumen  324  using a syringe or other application device. Additionally, a solvent or other material may be supplied to target site T via second lumen  324 , before, after, or during delivery of an agent preloaded in balloon lumen  334 . The solvent may activate an agent, an adhesive, or the like of the material supplied to target site T. Alternatively, the solvent may be supplied to target site T using a different lumen, as will be described herein. 
     An operation of balloon  330  will now be described with reference to  FIGS. 5A and 5B . Balloon  330  is inserted into the body and advanced to target site T in any manner described herein. Once balloon  330  is adjacent target site T, balloon  330  is inflated in any manner described herein, e.g., by supplying fluid F from a fluid containment device to first lumen  322  to inflate balloon  330 . According to an example, balloon lumen  334  is preloaded with a material. As balloon  330  inflates, inner wall  322   a  of first lumen  322  pushes against the material in balloon lumen  334 , supplying the material through openings  334   a  to target site T. When balloon  330  is sufficiently inflated and is adjacent target site T, the material exits openings  334   a , as shown by arrow R, to coat target site T. According to an example, a syringe or other similar device is attached to the proximal end of sheath  320  and may supply solvent to target site T via second lumen  324  after the material is dispensed from openings  334   a.    
     Alternatively, fluid F is first supplied from the fluid containment device to the first lumen  322 . Once balloon  330  is properly positioned and sufficiently inflated, material is supplied to target site T via second lumen  324  and openings  334   a . For example, a syringe or like device is attached to a proximal end of second lumen  324  and the material is dispensed from the syringe to second lumen  324 , and supplied to target site T. According to an example, a second material, e.g., a fluid or solvent, is supplied to second lumen  324  via, e.g., a syringe or like device, after the material is supplied to second lumen  324 . The second material may be suitable to move the initially-provided material along second lumen  324  to target site T and/or may provide additional therapeutic properties, e.g., to activate the material. After the material is supplied to target site T, balloon  330  is withdrawn from target site T in any manner described herein. 
     A balloon  430  according to another example will now be described with reference to  FIGS. 6A and 6B . Balloon  430  is similar to any of the balloons described herein, e.g., balloon  430  is attached proximal to a distal end  432  of a sheath  420  and includes a lumen  422  which extends from a proximal end of sheath  420  to balloon  430 . Balloon  430  further includes an outer wall  434  which may support a patch  440 , as will be described herein. Any other features of any of the other-described balloons may be incorporated into balloon  430 . 
     Patch  440  may be formed of a material, e.g., polysaccharides, biodegradable polyurethanes, poly (ethylene oxide) (PEO), poly (ethylene glycol) (PEG), or the like, that allows patch  440  to expand from a low profile, as shown in  FIG. 6A , to an expanded profile, as shown in  FIG. 6B . An outer surface of patch  440  may include a material, e.g., an adhesive, a reagent, or the like, and is configured to be applied to or attach to target site T to provide a therapeutic or regenerative treatment. According to an example, an inner surface of patch  440  (a surface facing outer wall  434 ) may also include an adhesive to affix patch  440  to balloon  430  during insertion. As will be explained herein, patch  440  may be removed from balloon  430  after patch  440  is attached to target site T. In some embodiments, a fluid may be supplied by shaft  20  to dissolve the adhesive between patch  440  and balloon  430 , while not altering properties of other materials on or in patch  440 . While a single patch  440  is shown, it will be understood that balloon  430  may support multiple patches according to the therapeutic need. In addition, while patch  440  may circumscribe all of balloon  430 , other embodiments of patches may circumscribe only a portion of balloon  430 . 
     As described herein, balloon  430  is inflated or expanded from the deflated configuration of  FIG. 6A  to the inflated configuration of  FIG. 6B  by supplying fluid F from a fluid containment device to balloon  430  via lumen  422 . As balloon  430  inflates, patch  440  similarly expands and may be pressed against target site T. Once patch  440  is properly positioned adjacent target site T, patch  440  may adhere to target site T. For example, radiofrequency (RF) electrodes may heat the material on the outer surface of patch  440 , curing the adhesive. Alternatively, or additionally, fluid F supplied to balloon  430  to inflate balloon  430  may have a temperature sufficient to heat the material on the outer surface of patch  440  and cure the adhesive. After the material is cured and patch  440  is adhered to target site T, balloon  430  is deflated. 
     According to another example, an adhesion force between balloon  430  and patch  440  may maintain a position of patch  440  relative to balloon  430  during insertion, and this adhesion force may be overcome after patch  440  is attached to target site T. For example, a cooling fluid (in one example, the cooling fluid may be fluid F) may be supplied to lumen  422  to cool outer surface  434  of balloon  430  and, thus, cool inner surface of patch  440 , thereby degrading the adhesive force between balloon  430  and patch  440 . Alternatively, or additionally, sheath  420  may be rotated about a central longitudinal axis, causing balloon  430  to rotate with respect to patch  440  and overcome the adhesive force between balloon  430  and patch  440 . In yet another example, an agent may be supplied from openings in balloon  430  and patch  440 , to degrade the adhesive between balloon  430  and patch  440 . The agent may be preloaded in openings in outer surface  434  and/or may be supplied via a separate lumen, according to examples described herein. 
     An operation of balloon  430  will now be described. Balloon  430  is inserted into the body and advanced to target site T in any manner described herein. Once balloon  430  is positioned adjacent target site T, balloon  430  is inflated in any manner described herein, e.g., by supplying fluid F from a fluid containment device to lumen  422  to inflate balloon  430 . As balloon  430  inflates, outer wall  434  pushes against patch  440  and causes patch  440  to expand outward from a central longitudinal axis of balloon  430 . When balloon  430  is sufficiently inflated and is adjacent target site T, outer wall  434  pushes or urges patch  440  against target site T. According to an example, an adhesive on an surface of patch  440  facing target site T may already be activated such that patch  440  adheres to target site T when patch  440  contacts target site T. Alternatively, an adhesive material on patch  440  may need to be activated or cured to maintain a position of patch  440  relative to target site T. In this example, an RF transmitter may be placed adjacent target site T, e.g., by being advanced along lumen  422  and into balloon  430 . Once the RF transmitter is appropriately positioned, the RF transmitter is activated by, e.g., applying a current to the RF transmitter, thereby generating heat, to activate or cure the adhesive material. Alternatively, fluid F used to inflate or expand balloon  430  may activate the adhesive material on the patch  440 , thereby curing the adhesive material to attach patch  440  to target site T. 
     Once patch  440  is attached to target site  440 , balloon  430  is removed from target site T. According to a first example, balloon  430  is deflated by removing fluid F from balloon  430 , as described herein. Alternatively, a user may first rotate sheath  420 , thereby causing balloon  430  to rotate and release patch  440  from balloon  430 . For example, in the event patch  440  uses an adhesive to maintain a position relative to balloon  430  during insertion to target site T, rotating sheath  420  may generate a force sufficient to overcome the adhesion force between balloon  430  and patch  440 . Alternatively, or additionally, a reagent may be supplied from the proximal end of sheath  420  to balloon  430 . The reagent may be supplied to an outer surface of outer wall  434  to counteract the adhesive forces between balloon  430  and patch  440 . After patch  440  is detached from balloon  430 , balloon  430  is deflated and may be withdrawn into a catheter, e.g., catheter  20  shown in  FIG. 1 , to remove balloon  430  from the body. 
     A balloon  530  according to another example will be described with reference to  FIGS. 7A and 7B . Balloon  530  is similar to any of the balloons described herein, e.g., balloon  530  is attached proximal to a distal tip  532  of a sheath  520  and includes a lumen  522  which extends from a proximal end of sheath  520  to balloon  530 . An inner wall  536   a  of balloon  530  includes a plurality of first openings  534   a  that are fluidly coupled with second openings  534   b  in an outer wall of balloon  530 . A balloon lumen  534  is defined by inner wall  536   a  and outer wall  536   b  of balloon  530 , and is fluidly coupled to openings  534   a  in inner wall  536   a  and openings  534   b  in outer wall  536   b . A sheath lumen  524  extends from a proximal end of sheath  520  and terminates proximal to balloon  530 . Sheath lumen  524  communicates with a plurality of third openings  524   a  in outer wall of sheath  520 , which will be described in greater detail herein. 
     As described herein, fluid F is supplied along lumen  522  from a proximal end of sheath  520  to balloon  530  to inflate or expand balloon  530 . According to an example, fluid F may include a solvent, such as a solvent having an acidic pH level of approximately 3-5, or a pH of approximately 4. As fluid F is supplied to balloon  530 , balloon  530  inflates or expands adjacent target site T, as shown in  FIG. 7B . A material, such as a therapeutic material or the like described herein, may be disposed (preloaded) within balloon lumen  534  in a powder or viscous fluid form. As balloon  530  inflates or expands, fluid F may pass from lumen  522 , through openings  534   a , and into lumen  534 , mixing with the material. This mixture is supplied via openings  534   b  to target site T. In some embodiments, an additional material or fluid, e.g., a curing agent, may be supplied to sheath lumen  524  and may be supplied to target site from sheath lumen  524  via openings  524   a . That curing agent, or other fluid, may be supplied before, during, or after delivery of the material to target site T. 
     An operation of balloon  530  will now be described. Balloon  530  is inserted into the body and advanced to target site T in any manner described herein. Once balloon  530  is positioned adjacent target site T, balloon  530  is inflated in any manner described herein, e.g., by supplying fluid F from a fluid containment device to lumen  522  to inflate balloon  530 . As balloon  530  inflates, an outer surface of balloon  530  approaches and/or abuts against target site T. During inflation, or just subsequent to inflation, fluid F passes from lumen  522  and within balloon  530  into balloon lumen  534  via openings  534   a . Fluid F mixes with material disposed within balloon lumen  534 , reducing the viscosity of the material and/or dissolving the material into a solution including the material and fluid F. The solution of material and fluid is subsequently supplied to target site T via openings  534   b . Alternatively, a pressure may be exerted by fluid F on the material in balloon lumen  534  and force the material from balloon lumen  534  to target site T via openings  534   b.    
     After the mixture, including fluid F from lumen  522  and the material from balloon lumen  534 , coats target site T, a second material, e.g., an activation fluid, may be supplied from a proximal end of sheath  520  to sheath lumen  524 . The second material or the second fluid may travel along sheath lumen  524  and be supplied to target site T via openings  524   a . It will be understood that balloon  530  may be deflated before, during, or after supplying the second material from openings  524   a . For example, the second material or the second fluid may be guided to target site T by a shape of a proximal end of balloon  530 , e.g., a sloping surface of balloon  530 . After the second fluid is supplied to target site T, balloon  530  is deflated and removed from the body in any manner described herein. 
     It will be apparent to those skilled in the art that various modifications and variations can be made to the disclosed device without departing from the scope of the disclosure. For example, any material or fluid may be contained in lumens or otherwise supplied to and/or from a balloon to be expelled from the application device to a target location, including but not limited to materials having therapeutic effects. Additionally, or alternatively, unless otherwise specified, the medical device described herein may be formed of any metal, alloy, plastic, or ceramic, or any combination thereof, suitable for use in medical applications. Other embodiments of the disclosure will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims.