Medical delivery device

Abstract

To provide improved endoscopic medical devices and related methods of use.SOLUTION: A medical device is provided, including: 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.SELECTED DRAWING: Figure 2A

Description

[Technical Field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates generally to endoscopic medical devices and related methods of use. More specifically, in some embodiments, the present disclosure relates to endoscopic medical tools and methods related to accessing and dispensing materials to a target site. [Background technology]

[0002] Certain medical procedures may require stopping or minimizing bleeding and / or delivering therapeutic materials to the body. For example, endoscopic medical procedures may require hemostasis of bleeding tissue within the digestive tract, such as in the esophagus, stomach, or intestines.

[0003] During an endoscopic procedure, a user inserts the sheath of the endoscope into a patient's body lumen. The user controls the endoscope during the procedure using the endoscope's handle. For example, tools are passed through the endoscope's working channel via ports in the handle to deliver treatment at a treatment site near the distal end of the endoscope, which is located remotely from the operator.

[0004] Hemostatic agents, regenerative agents, or tissue adhesives may be delivered by devices inserted into the working channel of an endoscope to achieve hemostasis at remote sites and / or promote natural tissue healing. Drug / adhesive delivery can be achieved, for example, via mechanical systems. However, such systems may not achieve the desired rate of drug delivery or the desired dosage of drug, potentially resulting in inconsistent drug administration or the drug not reaching the treatment site deep in the gastrointestinal tract. The current disclosure may solve one or more of these problems, or other problems in the art. Summary of the Invention [Means for solving the problem]

[0005] According to one 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 having an inflated configuration and a deflated configuration, the balloon defining at least one space radially inward of an outer surface of the balloon, the at least one space configured to hold a material, and 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 within a body.

[0006] The at least one lumen may include a sheath lumen, and the medical device may be configured to be attached to a fluid containing device, and fluid from the fluid containing device may be configured to be supplied to the sheath lumen to transition the balloon from a deflated configuration to an inflated configuration.

[0007] 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, and the at least one space may include a channel extending from each opening in the outer wall and fluidly coupled to the delivery lumen, and the delivery lumen may be fluidly separated from the sheath lumen.

[0008] The at least one space may include a balloon lumen disposed between the inner and outer walls of the balloon, and the balloon may include a plurality of openings in the outer wall of the balloon fluidly coupled to the balloon lumen.

[0009] Transitioning the balloon from the deflated configuration to the inflated configuration may open multiple openings. The balloon lumen and the sheath lumen may be separated by an inner wall, which may include an opening, and transition of the balloon from a deflated configuration to an inflated configuration may open the opening in the inner wall, fluidly connecting the sheath lumen to the balloon lumen.

[0010] The material may be configured to be disposed within the balloon lumen, and transition of the balloon from a deflated configuration to an inflated configuration may cause fluid to flow through openings in the inner wall, mix with the material, and deliver the material from the balloon lumen to the target site.

[0011] 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 at least in the deflated configuration, and at least one space may be at least partially defined by the folds, and at least one boundary of each fold may be reduced in the inflated configuration to expose the at least one space to the external environment.

[0012] The at least one lumen may include an outer lumen disposed around the sheath lumen, the outer lumen may extend from a proximal end of the sheath and terminate proximal to the balloon, and the outer wall of the sheath may include a sheath opening adjacent to the balloon and fluidly coupled to the outer lumen.

[0013] The balloon may not include an outer coating of material in the deflated configuration. At least one space may include a channel extending from the outer surface of the balloon toward the central longitudinal axis of the balloon, and each channel may include an opening in the outer surface of the balloon.

[0014] A material may be disposed within the channels in the contracted configuration, and each opening may be closed from the external environment in the contracted configuration to retain the material, and a transition from the contracted configuration to the expanded configuration may cause the material to be released from each channel through the opening.

[0015] 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, and the at least one space may include channels extending from the outer surface of the balloon toward the central longitudinal axis of the balloon, and each channel may include an opening in the outer surface of the balloon, and the channels and openings may be fluidly coupled to the delivery lumen.

[0016] The proximal end of the delivery lumen may be configured to be attached to a device containing a material, and the material may be configured to be delivered to a target site through the second lumen and the opening, and the delivery lumen may be fluidly isolated from any other lumen from the at least one lumen.

[0017] 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, the material being configured to be delivered to a target site.

[0018] The patch may include an adhesive on a second surface of the patch that may be configured to maintain the position of the patch relative to the balloon, and a fluid may be configured to be supplied to the balloon via the at least one lumen to inflate the balloon to an inflated configuration, and the fluid may be configured to change the temperature of the balloon to overcome adhesive forces between the patch and the balloon.

[0019] The at least one lumen may comprise a sheath lumen configured to receive a first fluid for inflating the balloon from a contracted configuration to an inflated configuration, and an outer lumen disposed around the sheath lumen, the outer lumen may extend from a proximal end of the sheath and terminate proximal to the balloon, the outer surface of the sheath may include an opening fluidly coupled to the outer lumen, and the second fluid may be configured to be delivered to a second surface of the patch through the opening to overcome adhesive forces of the adhesive between the patch and the balloon.

[0020] According to yet another aspect, a method of performing a medical procedure includes positioning a sheath adjacent to a target site within the body; supplying fluid to a sheath lumen of the sheath to transition a balloon at a distal end of the sheath from a contracted configuration to an inflated configuration; supplying material from the balloon to the target site from at least one space radially inward of an outer surface of the balloon as the balloon transitions from the contracted configuration to the inflated configuration; and withdrawing fluid from the sheath lumen to collapse the balloon from the inflated configuration to the contracted configuration.

[0021] The method may further include delivering a second fluid to the target site via an outer lumen around the sheath lumen, the second fluid configured to activate the material such that it adheres to the target site.

[0022] 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. [Brief explanation of the drawings]

[0023] [Figure 1] FIG. 1 is a perspective view of a medical system, according to one embodiment. [Figure 2A] 2 is a perspective view of a distal end of a medical tool of the medical system of FIG. 1 according to one embodiment. [Figure 2B] FIG. 2B is a cross-sectional view taken along line 2-2 of FIG. 2A. [Figure 3A] 1. FIG. 3 is a perspective view of a distal end of another medical tool of the medical system of FIG. 1, according to one embodiment. [Figure 3B] FIG. 3B is a cross-sectional view taken along line 3-3 of FIG. 3A. [Figure 4A] 1. FIG. 4 is a perspective view of a distal end of a medical tool of the medical system of FIG. 1 according to another embodiment. [Figure 4B] 1. FIG. 4 is a perspective view of a distal end of a medical tool of the medical system of FIG. 1 according to another embodiment. [Figure 4C] 1. FIG. 4 is a perspective view of a distal end of a medical tool of the medical system of FIG. 1 according to another embodiment. [Figure 5A] 1. FIG. 4 is a perspective view of a distal end of a medical tool of the medical system of FIG. 1 according to another embodiment. [Figure 5B] 1. FIG. 4 is a perspective view of a distal end of a medical tool of the medical system of FIG. 1 according to another embodiment. [Figure 6A] 1. FIG. 4 is a perspective view of a distal end of a medical tool of the medical system of FIG. 1 according to another embodiment. [Figure 6B] 1. FIG. 4 is a perspective view of a distal end of a medical tool of the medical system of FIG. 1 according to another embodiment. [Figure 7A] 1. FIG. 4 is a perspective view of a distal end of a medical tool of the medical system of FIG. 1 according to yet another embodiment. [Figure 7B] 1. FIG. 4 is a perspective view of a distal end of a medical tool of the medical system of FIG. 1 according to yet another embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0024] The present disclosure will be described with reference to an exemplary medical system that may be used to endoscopically dispense materials. However, it should be noted that reference to this specific procedure is provided for convenience only and is not intended to limit the disclosure. Those skilled in the art will recognize that the concepts underlying the disclosed devices and application methods may be utilized in any suitable medical or other treatment. The present disclosure can be understood with reference to the following description and the accompanying drawings, in which like elements are referred to with the same reference numerals.

[0025] For ease of explanation, the term "distal" refers to the portion of the system farthest from the user when introducing the system into a patient. In contrast, the term "proximal" refers to the portion of the system closest to the user when introducing the system into a patient. As used herein, the terms "comprises," "comprising," or any other variations thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or device that includes a list of elements does not necessarily include only those elements but may include other elements not expressly listed or other elements inherent to such process, method, article, or device. The term "exemplary" is used to mean "example" rather than "ideal." In this disclosure, relative terms such as "about," "substantially," "generally," and "approximately" are used to indicate a possible variation of ±10% of a stated value or characteristic.

[0026] Referring to FIG. 1 , a medical system 10 according to one embodiment is shown. The medical system 10 includes a flexible shaft 20 (e.g., a catheter) and a handle 40 connected to the proximal end of the flexible shaft 20. The handle 40, or other device for operating or controlling the medical system 10, and any tools or devices associated with the medical system 10, includes first and second actuators 42, 43. The actuators 42, 43 control the multi-directional articulation of the flexible shaft 20 and / or an articulation joint at the distal end of the flexible shaft 20. The actuators 42, 43 may be, for example, rotatable knobs that rotate about their axes to push or pull an actuator element (not shown). An actuator element, such as a cable or wire (e.g., medical-grade plastic or metal) suitable for a medical procedure, extends distally from the proximal end of the endoscope 10 and is connected to the flexible shaft 20 to control its movement. Alternatively, or additionally, a user can operate the actuator element independently of the handle 40. The distal ends of the actuation elements extend through the flexible shaft 20 and terminate at an articulation joint and / or the distal tip of the flexible shaft 20. For example, one or more actuation elements may be connected to the articulation joint, and actuation of the actuation elements may control the articulation joint or distal tip of the flexible shaft 20 to move in multiple directions.

[0027] Additionally, one or more electrical cables (not shown) may extend from the proximal end of the endoscope 10 to the distal end of the flexible shaft 20, providing electrical control for imaging, illumination, and / or other electrical devices at the distal end of the flexible shaft 20 and transmitting image signals from the distal end of the flexible shaft 20 to the proximal end for processing and / or display on a display. The handle 40 may also include ports 44, 46 for introducing and / or removing tools, fluids, or other materials from the patient. The port 44 can be used to introduce tools. The port 46 may be connected to an umbilicus for fluid introduction, suction, and / or wiring of electronic components. For example, as shown in FIG. 1 , the port 44 is connected to the lumen 22 extending from the proximal end to the distal end of the flexible shaft 20. The port 44 can receive a medical device, such as a flexible sheath 120 (e.g., a catheter) for a medical device.

[0028] 1, the sheath 120 may include a lumen 122 extending therethrough from the proximal end to the distal end of the sheath 120. The sheath 120 may incorporate or have attached to it the distal end of an actuator 140. The actuator 140 is a Y-shaped member having a first channel 123 with a first opening 123a and a second channel 124 with a second opening 124a. As described herein, the first and second channels 123, 124 may be in communication with the lumen 122 and may be used to inflate or deflate a balloon 130 at the distal end of the sheath 120. For example, first channel 123 may be attached to a containment device (not shown) having fluid F, and fluid F (e.g., as indicated by the arrow in FIG. 2A ) may be supplied to first channel 123 to inflate balloon 130, while second channel 124 may be attached to a reservoir to withdraw fluid F from balloon 130 into the containment device, thereby deflating balloon 130. It will be understood that actuation device 140 is not limited to two channels. For example, as described herein, additional channels may be included in actuation device 140 to provide additional fluids and / or materials to the distal end of sheath 120. As a further example, actuation device 140 may include only a single channel for selectively introducing or removing materials, including fluids, into or from lumen 122.

[0029] 1, 2A, and 3A, the catheter 20 includes multiple lumens, e.g., a first lumen 22, a second lumen (for ease of illustration, the second lumen is not shown, but extends from the proximal end of the catheter 20 to an opening 24a as shown in FIG. 1), and a third lumen 26 extending from the proximal end of the catheter 20 to an opening 26a. According to one example, the first lumen 22 is configured to receive a sheath 120 of a medical device, as described in more detail herein. The first lumen 22 extends from the handle 40 and terminates at a first opening 22a at a distal end face 28 of the catheter 20. The second and third lumens 26 can receive additional tools and / or can be used for suction / vacuum, fluid distribution, imaging, illumination, etc. For example, the distal openings 24a, 26a of the second and third lumens 26 can be open at the distal end face 28 of the catheter 20. According to one example, fluid may travel from the handle 40 along the second and third lumens 26, respectively, and then be expelled through one or both of the openings 24a, 26a. Alternatively, debris may be aspirated / vacuumed through one or both of the openings 24a, 26a, and / or electrical fibers may be disposed in one or both of the second and third lumens 26 to attach imaging elements, such as cameras, or illumination elements, such as light-emitting diodes (LEDs), disposed in the openings 24a, 26a. These components may be fixed to the openings 24a, 26a or may extend from the distal end face 28 to provide additional illumination and / or imaging of the target site T. For ease of illustration, the catheter 20 is shown only in FIGS. 1, 2A, and 3A. However, it will be understood that any of the medical tools described herein may access the target site T by passing through the lumen 22 of the catheter 20.

[0030] Continuing with reference to FIG. 1 , the sheath 120 extends within the first lumen 22 of the catheter 20. The sheath 120 is flexible and has an outer diameter smaller than the inner diameter of the first lumen 22, thereby allowing the sheath 120 to slide within and along the first lumen 22. The sheath 120 includes an inflatable balloon 130 at its distal-most end. The 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 CO2. As described herein, the balloon 130 can be inflated distally of the distal-most end of the catheter 20 adjacent the target site T to deliver a material, such as a hemostatic or regenerative agent, to the target site T.

[0031] 2A shows catheter 20 positioned adjacent to target site T in body lumen L. Sheath 120 is advanced along first lumen 22, e.g., by pushing the proximal end of sheath 120, exposing balloon 130 at distal end face 28 of catheter 20. For example, a user may insert balloon 130 into port 44 of handle 40 and advance balloon 130 along lumen 22 by pushing sheath 120. This movement exposes balloon 130 from first opening 22a. As described herein, openings 24a, 26a may include illumination and / or imaging elements that may assist in positioning balloon 130.

[0032] 2A and 2B, the target site T protrudes into the lumen L. As described above, the catheter 20 may include actuation elements, such as cables, extending from the handle 40 to the distal end of the catheter 20. Pulling these cables can bend the ends of the catheter 20 as needed to properly position the balloon 130 adjacent the target site T. Alternatively, or additionally, a guidewire (not shown) may be advanced adjacent the target site T. The sheath 120 may include a central lumen (not shown) and may be advanced over the guidewire.

[0033] 2A, the balloon 130 is in a deflated configuration and is located adjacent to the target site T, distal to the distal end face 28 of the catheter 20. The sheath 120 includes a distal tip 132, and the balloon 130 is disposed proximal to the distal tip 132. Referring to FIG. 2B, a cross section taken along line 2-2 of FIG. 2A shows that the balloon 130 has a collapsed body 134. As described herein, the balloon 130 is inflated from the deflated configuration by supplying a fluid F to the balloon 130 via the lumen 122.

[0034] As further shown in FIG. 2B , the body 134 includes folds 135 that, in the contracted configuration, create pockets or spaces 136 between adjacent folds 135. The pockets 136 contain a material, such as a hemostatic or regenerative agent, to be delivered to the target site T, as described herein. The balloon 130 may be compliant or non-compliant and may include any number of folds 135. Each fold 135 may cover a portion of an adjacent fold 135 to create a pocket 136. In other embodiments, adjacent folds 135 do not overlap one another. Each fold 135 also lies radially outward of a portion of the outer surface of the balloon 130 that is not part of the fold 135, forming the pocket 136. In some examples, the folds 135 are the radially outermost portion of the balloon 130; for example, in some examples, there is no covering of the folds 135 and / or the outermost surface of the balloon 130. The folds 135 can create pockets 136 for the drugs and may extend completely around the circumference of the balloon 130, although in some embodiments, the folds 135 may be present only on portions of the balloon 130, e.g., the folds 135 may extend only partially around the circumference of the balloon 130 to target desired areas of tissue for treatment. In some embodiments, different drugs may be disposed within different folds 135 around different portions of the balloon 130. For example, some folds 135 may contain an inert agent, while other folds 135 may contain a catalyst, which may activate the inert agent when the balloon 130 is expanded and the inert agent and catalyst come into contact. Alternatively, or additionally, various drugs may degrade or lose their effectiveness with prolonged exposure to other drugs. Disposing different drugs in different folds 135 can improve the longevity of these drugs and improve the effectiveness of the drugs after they are disposed at the target site T.

[0035] 3A and 3B (showing a cross section of the balloon 130 taken along line 3-3 in FIG. 3A ), the balloon 130 is shown in an inflated position. According to one example, the balloon 130 can be inflated by supplying a fluid F, such as a gas or liquid, to the lumen 122 of the sheath 120 via an actuation mechanism 140. For example, one of the first or second channels 123, 124 can be connected to a containment device that stores the fluid F. The fluid F can travel along the lumen 122, filling the balloon 130 and inflating it. In the inflated or expanded position, the body 134 of the balloon 130 assumes a cylindrical or rounded shape, and the folds 135 and corresponding pockets 136 (see FIG. 2A ) in the body 134 partially or completely disappear, exposing the material to the target site T (see FIGS. 3A and 3B ). During and upon inflation, material underlying the folds 135 in the pockets 136 is released. 3A, balloon 130 is close to or adjacent to target site T, allowing material to be delivered to target site T. After the material has been delivered to target site T, balloon 130 is deflated.

[0036] Next, the operation of the balloon 130 will be described. Catheter 20 is inserted into the body through a natural orifice or incision in the 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 is understood that sheath 120 may be inserted into port 44 prior to the start of the procedure, for example, prior to inserting catheter 20 into the body, or may be advanced to target site T simultaneously with catheter 20.

[0037] After the catheter 20 and sheath 120 are positioned adjacent to the target site T, the proximal end of the sheath 120 is manipulated to move the sheath 120 distally relative to the catheter 20 along the first lumen 22. Moving the sheath 120 distally forces the balloon 130 toward the distal end of the catheter 20 and out of the first opening 22a in the distal end face 28, thereby positioning the balloon 130 adjacent to the target site T.

[0038] After the balloon 130 is positioned adjacent to the target site T outside the first lumen 22, the balloon 130 is inflated. According to one example, inflating the balloon 130 includes attaching one of the first or second channels 123, 124 to a fluid containing device and supplying fluid F to the lumen 122. The fluid F is transported along the lumen 122 of the sheath 120 to the balloon 130. Once the balloon 130 is filled with fluid F, the body 134 of the balloon 130 inflates or expands, releasing material within the pockets 136 in the folds 135. Further inflation or expansion of the body 134 presses the body 134 toward and against the target site T, further smoothing the folds 135 of the body 134 and forcing the material toward the target site T. The fluid F can remain within the balloon 130 for a period sufficient to transport the material to the target site T, for example, about 10 minutes or less, or about 1 minute or less. This period of time may depend on the material of the balloon 130 and / or the fluid F, its interaction with the target site T, and / or the preference of the physician performing the medical procedure. Additionally, this period of time may vary depending on when the opening in the target site T is closed. According to one example, the balloon 130 may be adjacent to the target site T and pressure may be applied to the material to seal off bleeding / cuts or close tears or openings in the target site T.

[0039] Once the material has been sufficiently transferred to the target site T or the target site T has otherwise been treated, the balloon 130 is deflated by removing the fluid F. For example, to remove the fluid F, the other of the first or second channels 123, 124 is attached to a fluid containing device, and fluid is moved from the balloon 130 along the lumen of the sheath 120 to the fluid containing device via a user-operated syringe or pump, or an electric pump associated with the fluid containing device. Once the fluid F has been removed from the balloon 130, the balloon 130 collapses on itself, and the balloon 130 can be removed from the body, for example, by moving the sheath 120 proximally to move the balloon 130 into the lumen 22 of the catheter 20. Alternatively, or additionally, the balloon 130 may be removed from the body by moving the balloon 130 along a guidewire.

[0040] Another example balloon 230 is shown in FIGS. 4A-4C. Although not shown, the balloon 230 may be introduced into the body using a catheter and / or guidewire, as described herein. The balloon 230 is proximal to the distal tip 232 of the sheath 120 and includes flexible channels 234 pre-loaded with a material, such as a therapeutic or regenerative material, as described herein. The channels 234 are laterally bounded by the outer surface 224a of the body 224 of the balloon 230. A radially inner portion of each channel 234 is bounded by the outer surface of the sheath 120 (or a surface of the balloon 130 secured to the outer surface of the sheath 120). A radially outer portion of each channel 234 defines a channel opening 234a. As shown in FIG. 4A , when balloon 230 is in a deflated orientation, a portion of body 224 of balloon 230 overlaps with each channel opening 234a of channels 234 and generally contains material into channels 234, although some shedding of material from channels 234 may occur. As shown in FIG. 4B , as balloon 230 is inflated from the deflated configuration by supplying fluid F to balloon 230 through lumen 222, the portion of body 224 covering channel openings 234a moves away from channel openings 234a, opening channel openings 234a (exposing them to the body lumen). This allows material to flow from channels 234 through channel openings 234a to target site T, as indicated by arrow R. For example, fluid F may be supplied along lumen 222, e.g., at its distal end, to opening 160 of lumen 222 and supplied to balloon 230 through opening 160, thereby inflating balloon 230. It will be appreciated that channel opening 234a may be closed in the contracted configuration by any other structure, such as a perforated wall of balloon 230 that may rupture when balloon 230 is fully inflated. Perforations or other similar closure mechanisms may similarly be used to selectively close the openings described herein.

[0041] 4C illustrates the balloon 230 in a fully inflated configuration, with material completely or nearly completely expelled from the channels 234. According to one example, the outer surfaces 224a defining each of the channels 234 may be adjacent to one another when in the fully inflated configuration, which can help maximize the amount of material expelled from each of the channels 234. The balloon 230 is not in contact with the target tissue T in FIGS. 4B and 4C. However, it will be understood that the balloon 230 may contact and press against the target tissue T.

[0042] According to one embodiment, the channels 234 are generally cylindrical and have a longitudinal axis that is transverse to the longitudinal axis of the sheath 120 (at least when expanded), and in some cases is approximately perpendicular to the longitudinal axis of the sheath 120. However, the orientation and shape of the channels 234 are not so limited; the channels 234 may be in any orientation, e.g., angled relative to the longitudinal axis, and may be any shape, e.g., conical, cylindrical, or cubical, sufficient to store material and deliver the material to the target site T. Furthermore, the number and / or arrangement of the channels 234 are not limited. For example, the channels 234 may be evenly or randomly spaced along the balloon 230. In some examples, additional sclerosing agent may be provided to the channels 234 along the lumen of the sheath 120, separate from the lumen 222, as described herein. In other examples, some channels 234 may contain a first agent and other channels 234 may contain a second agent, e.g., a sclerosing agent.

[0043] The operation of balloon 230 will now be described. Balloon 230 is inserted into the body and advanced to target site T by any method described herein. Once balloon 230 is positioned adjacent target site T, balloon 230 is inflated by any method described herein, such as by supplying fluid F along lumen 222 to an opening in lumen 222. Because opening 160 is in fluid communication with balloon 230, balloon 230 begins to inflate, which moves body 224 to unblock channel opening 234a. As channel opening 234a is covered open, material stored in channel 234 is exposed to target site T. Material may be forced out of channel 234 through channel opening 234a by the pressure of balloon 230 expanding toward channel 234. As balloon 230 continues to inflate, material continues to be expelled. When balloon 130 is fully inflated, surfaces 224a defining each of channels 234 may contact one another, which may assist in expelling material from channels 234. After the material has sufficiently coated target site T, balloon 230 may be deflated and removed from the body by any method described herein.

[0044] Another embodiment of a balloon 330 is shown in FIGS. 5A and 5B. Although not shown, the balloon 330 may be introduced into the body using a catheter and / or guidewire, as described herein. The balloon 330 is located proximal to the distal tip 332 of a sheath 320. The sheath 320 includes a first lumen 322 and a second lumen 324, each extending from the proximal end of the sheath 320 to the balloon 330. The first lumen 322 receives fluid F from a fluid containing device, as described herein, and inflates the balloon 330, as described herein. The first lumen 322 is also used for deflating the balloon 330, as described herein. The second lumen 324 is connected to the balloon lumen 334 and receives and delivers materials and / or other fluids, such as reagents, adhesives, air, and / or water, to the target site T via an opening 334a on the outer surface of the balloon 330. Opening 334a is fluidly connected to second lumen 324 via balloon lumen 334. As shown in Figures 5A and 5B, balloon lumen 334 is defined by outer wall 334b ​​of balloon 330 and inner wall 322a of balloon 330, and is fluidly separated from lumen 322 via inner wall 322a. Thus, balloon lumen 334 can be an annular, ring-shaped space or cavity that completely surrounds the interior of balloon 330, which receives fluid F. In other embodiments, balloon lumen 334 can only partially surround the interior of balloon 330.

[0045] According to one example, a material may be pre-loaded into the second lumen 324 and may exit the opening 334a in the outer wall 334b ​​due to pressure on the balloon 330 when the balloon 330 is inflated. Additionally or alternatively, a fluid may be supplied along the second lumen 324 to force the material through the opening 334a and / or mix with the material, thereby forcing the mixture out of the opening 334a. According to another example, a material may be supplied to the second lumen 324 after the balloon 330 is inflated, for example, by supplying the material to the second lumen 324 using a syringe or other application device. Additionally, a solvent or other material may be supplied to the target site T via the second lumen 324 before, after, or during delivery of a drug pre-loaded in the balloon lumen 334. The solvent may activate a drug, adhesive, or the like in the material supplied to the target site T. Alternatively, as described herein, the solvent may be supplied to the target site T using a different lumen.

[0046] The operation of balloon 330 will now be described with reference to Figures 5A and 5B. Balloon 330 is inserted into the body and advanced to target site T by any method described herein. Once balloon 330 is positioned adjacent to target site T, balloon 330 is inflated by any method described herein, such as by supplying fluid F from a fluid containing device to first lumen 322 to inflate balloon 330. According to one example, balloon lumen 334 is pre-loaded with material. When balloon 330 is inflated, inner wall 322a of first lumen 322 pushes the material within balloon lumen 334, delivering the material through opening 334a to target site T. Once balloon 330 is fully inflated and positioned adjacent to target site T, the material exits opening 334a, as indicated by arrow R, to coat target site T. According to one example, a syringe or other similar device can be attached to the proximal end of the sheath 320 to deliver solvent to the target site T via the second lumen 324 after the material has been dispensed from the opening 334a.

[0047] Alternatively, fluid F may be initially delivered from a fluid containing device into first lumen 322. Once balloon 330 is properly positioned and sufficiently inflated, material is delivered to target site T via second lumen 324 and opening 334a. For example, a syringe or similar device may be attached to the proximal end of second lumen 324, and material may be dispensed from the syringe into second lumen 324 and delivered to target site T. According to one example, a second material, e.g., a fluid or solvent, may be delivered to second lumen 324, e.g., via a syringe or similar device, after the material has been delivered to second lumen 324. The second material may be suitable for transporting the initially delivered 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 has been delivered to target site T, balloon 330 is withdrawn from target site T by any method described herein.

[0048] Another example balloon 430 will now be described with reference to Figures 6A and 6B. Balloon 430 is similar to any of the balloons described herein, e.g., balloon 430 is attached proximal to distal end 432 of sheath 420 and includes lumen 422 extending from the proximal end of sheath 420 to balloon 430. Balloon 430 further includes outer wall 434 that may support patch 440, as described herein. Any other features of any of the other described balloons may also be incorporated into balloon 430.

[0049] Patch 440 can be formed from a material, such as a polysaccharide, biodegradable polyurethane, poly(ethylene oxide) (PEO), poly(ethylene glycol) (PEG), etc., that allows patch 440 to expand from a low profile as shown in FIG. 6A to an expanded profile as shown in FIG. 6B. The outer surface of patch 440 can include a material, such as an adhesive, a reagent, etc., and is configured to be applied to or adhere to target site T to provide therapeutic or regenerative treatment. According to one example, the inner surface of patch 440 (the surface facing outer wall 434) can also include an adhesive to secure patch 440 to balloon 430 during insertion. As described herein, patch 440 can be removed from balloon 430 after it is attached to target site T. In some embodiments, a fluid can be supplied by shaft 20 to dissolve the adhesive between patch 440 and balloon 430 without changing the properties of other materials on or within patch 440. Although a single patch 440 is shown, it will be understood that the balloon 430 may support multiple patches depending on the needs of the treatment. Furthermore, the patch 440 may circumscribe the entire balloon 430, although other embodiments of the patch may circumscribe only a portion of the balloon 430.

[0050] As described herein, the 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 containing device to the balloon 430 via the lumen 422. As the balloon 430 expands, the patch 440 may similarly expand and press against the target site T. Once the patch 440 is properly positioned adjacent the target site T, the patch 440 may be adhered to the target site T. For example, a radio frequency (RF) electrode may heat a material on the outer surface of the patch 440 to harden the adhesive. Alternatively, or additionally, the fluid F supplied to the balloon 430 to inflate it may have a temperature sufficient to heat the material on the outer surface of the patch 440 and harden the adhesive. After the material hardens and the patch 440 is adhered to the target site T, the balloon 430 is deflated.

[0051] According to another example, adhesive forces between the balloon 430 and the patch 440 can maintain the position of the patch 440 relative to the balloon 430 during insertion, and these adhesive forces can be overcome after the patch 440 is attached to the target site T. For example, a cooling fluid (in one example, the cooling fluid can be fluid F) can be supplied to the lumen 422 to cool the outer surface 434 of the balloon 430 and the inner surface of the patch 440, thereby reducing the adhesive forces between the balloon 430 and the patch 440. Alternatively, or additionally, the sheath 420 can be rotated about the central longitudinal axis to rotate the balloon 430 relative to the patch 440 and overcome the adhesive forces between the balloon 430 and the patch 440. In yet another example, a drug can be supplied through openings in the balloon 430 and the patch 440 to break down the adhesive between the balloon 430 and the patch 440. According to examples described herein, the drug can be pre-loaded into the openings in the outer surface 434 and / or supplied via a separate lumen.

[0052] The operation of the balloon 430 will now be described. The balloon 430 is inserted into the body and advanced to the target site T by any method described herein. Once the balloon 430 is positioned adjacent to the target site T, the balloon 430 is inflated by any method described herein, such as, for example, by supplying fluid F from a fluid containing device into the lumen 422 to inflate the balloon 430. When the balloon 430 is inflated, the outer wall 434 presses against the patch 440, causing the patch 440 to expand outward from the central longitudinal axis of the balloon 430. Once the balloon 430 is fully inflated and positioned adjacent to the target site T, the outer wall 434 presses or urges the patch 440 against the target site T. According to one example, the adhesive on the surface of the patch 440 facing the target site T may already be activated so that the patch 440 adheres to the target site T when the patch 440 contacts the target site T. Alternatively, the adhesive on patch 440 may need to be activated or cured to maintain the position of patch 440 relative to target site T. In this example, an RF transmitter may be positioned adjacent to target site T, for example, by being advanced along lumen 422 and into balloon 430. Once the RF transmitter is properly positioned, it is activated, for example, by applying a current to the RF transmitter, thereby generating heat and activating or curing the adhesive. Alternatively, the fluid F used to inflate or expand balloon 430 may activate the adhesive on patch 440, thereby curing the adhesive and adhering patch 440 to target site T.

[0053] Once the patch 440 is attached to the target site T, the balloon 430 is removed from the target site T. According to a first example, the balloon 430 is deflated by removing the fluid F from the balloon 430, as described herein. Alternatively, a user can first rotate the sheath 420, thereby rotating the balloon 430, to release the patch 440 from the balloon 430. For example, if the patch 440 uses an adhesive to maintain its position relative to the balloon 430 during insertion into the target site T, rotating the sheath 420 can generate a force sufficient to overcome the adhesive forces between the balloon 430 and the patch 440. Alternatively, or additionally, a reagent may be supplied to the balloon 430 from the proximal end of the sheath 420. The reagent may be supplied to the outer surface of the outer wall 434 to counteract the adhesive forces between the balloon 430 and the patch 440. After patch 440 is detached from balloon 430, balloon 430 may be deflated and withdrawn into a catheter, such as catheter 20 shown in FIG. 1, and removed from the body.

[0054] Another example balloon 530 is described with reference to Figures 7A and 7B. The balloon 530 may be similar to any of the balloons described herein, for example, the balloon 530 is attached proximal to a distal tip 532 of a sheath 520 and includes a lumen 522 extending from the proximal end of the sheath 520 to the balloon 530. An inner wall 536a of the balloon 530 includes a plurality of first openings 534a fluidly coupled to second openings 534b in the outer wall of the balloon 530. The balloon lumen 534 is defined by the inner and outer walls 536a and 536b of the balloon 530 and is fluidly coupled to the openings 534a in the inner wall 536a and the openings 534b in the outer wall 536b. A sheath lumen 524 extends from the proximal end of the sheath 520 and terminates proximal to the balloon 530. Sheath lumen 524 communicates with a plurality of third openings 524a in the outer wall of sheath 520, which will be described in more detail herein.

[0055] As described herein, fluid F is delivered along lumen 522 from the proximal end of sheath 520 to balloon 530 to inflate or expand balloon 530. According to one example, fluid F may include a solvent having an acidic pH level of about 3-5, or a pH of about 4. When fluid F is delivered to balloon 530, balloon 530 inflates or expands adjacent target site T, as shown in FIG. 7B. A material, such as a therapeutic material described herein, may be disposed (pre-loaded) within balloon lumen 534 in the form of a powder or viscous fluid. When balloon 530 is inflated or expanded, fluid F may enter lumen 534 from lumen 522 through opening 534a and mix with the material. This mixture may be delivered to target site T via opening 534b. In some embodiments, additional materials or fluids, such as a sclerosing agent, may be delivered to sheath lumen 524 and delivered to the target site from sheath lumen 524 via opening 524a. The sclerosing agent or other fluid may be provided before, during, or after delivery of the material to the target site T.

[0056] The operation of balloon 530 will now be described. Balloon 530 is inserted into the body and advanced to target site T by any method described herein. Once balloon 530 is positioned adjacent to target site T, balloon 530 is inflated by any method described herein, such as, for example, by supplying fluid F from a fluid containing device into lumen 522 to inflate balloon 530. As balloon 530 is inflated, the outer surface of balloon 530 approaches and / or is adjacent to target site T. During or immediately after inflation, fluid F passes from lumen 522 through balloon 530 and enters balloon lumen 534 via opening 534a. Fluid F mixes with a material disposed within balloon lumen 534, reducing the viscosity of the material and / or dissolving the material into a solution containing material and fluid F. The solution of material and fluid is then delivered to target site T via opening 534b. Alternatively, pressure may be applied to the material within the balloon lumen 534 by fluid F, forcing the material out of the balloon lumen 534 and through openings 534b to the target site T.

[0057] After the mixture including fluid F from lumen 522 and material from balloon lumen 534 coats target site T, a second material, e.g., an activation fluid, may be delivered from the proximal end of sheath 520 to sheath lumen 524. The second material or second fluid may travel along sheath lumen 524 and be delivered to target site T through opening 524a. It will be appreciated that balloon 530 may be deflated before, during, or after delivering the second material through opening 524a. For example, the second material or second fluid may be guided to target site T by the shape of the proximal end of balloon 530, e.g., a beveled surface of balloon 530. After the second fluid is delivered to target site T, balloon 530 is deflated and removed from the body by any method described herein.

[0058] It will be apparent to those skilled in the art that various modifications and variations can be made to the disclosed devices without departing from the scope of the present disclosure. For example, any material or fluid may be contained in the lumen or otherwise delivered to the balloon and / or delivered from the balloon and discharged from the application device to a target location, including, but not limited to, therapeutically effective materials. Additionally or alternatively, unless otherwise specified, the medical devices described herein may be formed from any metal, alloy, plastic, ceramic, or any combination thereof suitable for use in medical applications. Other embodiments of the present 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 the true scope and spirit of the invention being indicated by the following claims.

Claims

1. 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, the balloon having an inflated configuration and a deflated configuration, the balloon defines at least one space radially inward of an outer surface of the balloon, the at least one space configured to hold a material; A medical device, wherein 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 within the body.

2. 2. The medical device of claim 1, wherein the at least one lumen includes a sheath lumen, the medical device is configured to be attached to a fluid containing device, and fluid from the fluid containing device is configured to be supplied to the sheath lumen to transition the balloon from the deflated configuration to the inflated configuration.

3. 3. The medical device of claim 1, wherein the balloon includes folds in at least the deflated configuration, the at least one space being at least partially defined by the folds, and at least one boundary line of each fold being reduced in the inflated configuration to expose the at least one space to the external environment.

4. The medical device of any one of claims 1 to 3, wherein the balloon does not include an outer coating of the material in the deflated configuration.

5. The medical device of claim 1 or 2, wherein the at least one space comprises a channel extending from an outer surface of the balloon toward a central longitudinal axis of the balloon, each channel comprising an opening in the outer surface of the balloon.

6. 6. The medical device of claim 5, wherein the material is disposed within the channels in the contracted configuration, each opening is closed from the external environment in the contracted configuration to retain the material, and transitioning from the contracted configuration to the expanded configuration causes the material to be released from each channel through the opening.

7. 3. The medical device of claim 1, wherein the at least one lumen comprises a delivery lumen defined by an outer wall of the balloon and an inner wall of the balloon, and the at least one space comprises channels extending from the outer surface of the balloon toward a central longitudinal axis of the balloon, each channel comprising an opening in the outer surface of the balloon, the channels and the openings being fluidly coupled to the delivery lumen.

8. 8. The medical device of claim 7, wherein the proximal end of the delivery lumen is configured to be attached to a device containing the material, and the material is configured to be delivered to a target site through the second lumen and the opening, and the delivery lumen is fluidly isolated from any other lumen from the at least one lumen.

9. 3. The medical device of claim 2, wherein the at least one lumen further comprises a delivery lumen defined by an outer wall of the balloon and an inner wall of the balloon, and the at least one space comprises a channel extending from each opening in the outer wall and fluidly coupled to the delivery lumen, the delivery lumen being fluidly isolated from the sheath lumen.

10. 3. The medical device of claim 2, wherein the at least one space comprises a balloon lumen disposed between an inner wall and an outer wall of the balloon, the balloon comprising a plurality of openings in the outer wall of the balloon fluidly coupled to the balloon lumen.

11. The medical device of claim 10 , wherein transitioning the balloon from the deflated configuration to the inflated configuration opens the plurality of openings.

12. 11. The medical device of claim 10, wherein the balloon lumen and the sheath lumen are separated by the inner wall, the inner wall including an opening, and transition of the balloon from the deflated configuration to the inflated configuration opens the opening in the inner wall, fluidly coupling the sheath lumen to the balloon lumen.

13. 13. The medical device of claim 12, wherein the material is configured to be disposed within the balloon lumen, and transition of the balloon from the deflated configuration to the inflated configuration causes the fluid to flow through the openings in the inner wall, mix with the material, and deliver the material from the balloon lumen to the target site.

14. The medical device of any one of claims 10 to 13, wherein the plurality of openings in the outer wall of the balloon are sealed in the deflated configuration by a perforated membrane.

15. The medical device of any one of claims 3 to 14, wherein the at least one lumen further includes an outer lumen disposed around the sheath lumen, the outer lumen extending from a proximal end of the sheath and terminating proximal to the balloon, and an outer wall of the sheath including a sheath opening adjacent to the balloon and fluidly coupled to the outer lumen.

Images