Medical delivery devices and methods of use

Abstract

The present invention relates to a medical system comprising a handle, a sheath extending from the handle, and an end effector connected to a distal end of the sheath, wherein the end effector directs a quantity of material toward a target site in the body and causes release of the material onto the target site.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of priority to U.S. Provisional Application No. 62 / 942,919, filed on December 3, 2019, which is incorporated herein by reference in its entirety. Technical Field

[0003] The present disclosure generally relates to endoscopic medical devices and related methods of use. More particularly, in some embodiments, the present disclosure relates to endoscopic medical tools and methods related to accessing a target site and dispensing material to the target site. Background Art

[0004] During certain medical procedures, it may be necessary to stop or minimize bleeding inside the body. For example, endoscopic medical procedures may require hemostasis of bleeding tissue within the gastrointestinal tract, such as the esophagus, stomach, or intestines.

[0005] During endoscopic surgery, a user inserts the sheath of an endoscope into a patient's body cavity. The user controls the endoscope using its handle during the procedure. Tools are passed through the endoscope's working channel, for example via a port in the handle, to deliver therapy to a surgical site near the distal end of the endoscope. The surgical site is located remote from the operator.

[0006] To achieve hemostasis at a remote site, a hemostatic agent can be delivered via a device that is inserted into the working channel of an endoscope. For example, drug delivery can be achieved via a mechanical system. However, such systems may not achieve the desired rate of drug delivery or the desired dose of the drug, may result in inconsistent drug doses, or may result in the drug not reaching the treatment site deep within the gastrointestinal tract. The present disclosure may address one or more of these or other issues of the prior art. Summary of the Invention

[0007] According to one embodiment, a medical system includes a handle, a sheath extending from the handle, and an end effector connected to a distal end of the sheath, wherein the end effector is configured to direct a quantity of material toward a target site of the body and cause release of the material onto the target site.

[0008] The medical system may include a catheter comprising a catheter lumen, wherein the sheath may be configured to extend through the catheter lumen, and wherein the catheter may further include a fluid lumen fluidly detached from the catheter lumen, wherein the fluid lumen may be configured to attach to a fluid source and dispense fluid from a fluid opening at a distal end of the catheter.

[0009] The medical system may further include a balloon containing a volume of material, wherein the end effector may be configured to advance the balloon along the lumen of the catheter and through the lumen opening at the distal end of the catheter to the target site.

[0010] The end effector may include a pair of jaws, and wherein the capsule may include a tether configured to be grasped by the pair of jaws.

[0011] The end effector may be configured to pull the tether to open the capsule.

[0012] The outer covering of the balloon may include a material configured to adhere to the target site when exposed to fluid.

[0013] The outer covering of the balloon may comprise a material that dissolves when exposed to fluid.

[0014] The end effector can be configured to move from a collapsed configuration to an expanded configuration, wherein the end effector can have an umbrella-like shape in the expanded configuration such that a distal end of the end effector can have a larger diameter than a proximal end of the end effector.

[0015] The catheter may include a balloon within a lumen of the catheter.

[0016] The end effector may comprise a shape memory material, wherein the temperature of the end effector may be configured to increase due to body heat, and wherein the end effector may expand from a collapsed configuration to an expanded configuration when the end effector is above a temperature threshold.

[0017] The catheter may include a balloon comprising a volume of material, wherein the diameter of the distal opening of the catheter lumen may be smaller than the diameter of the balloon.

[0018] The distal end of the catheter lumen may include a protrusion extending from a wall of the catheter lumen toward a central longitudinal axis of the catheter, the protrusion configured to rupture the balloon.

[0019] The end effector may have a diameter that is smaller than a diameter of the distal opening of the catheter lumen, and wherein the end effector may be configured to extend out of the catheter lumen and distal to a distal-most end of the catheter.

[0020] The end effector may have a disc-shaped distal surface for applying pressure to the material at the target site.

[0021] The material may be a hemostatic or therapeutic agent.

[0022] According to another embodiment, a medical system includes an actuation handle, a sheath, a catheter, a balloon, and an end effector; the sheath extends from a distal end of the handle, the catheter includes a catheter lumen, wherein the sheath is configured to extend through the catheter lumen; the balloon contains material, wherein the balloon includes a tether; the end effector is connected to the distal end of the sheath and is configured to grasp the tether; wherein the end effector is configured to advance the balloon along the catheter lumen and to a target site through a catheter lumen opening at the distal end of the catheter; wherein an outer portion of the balloon includes a material configured to adhere to the target site when exposed to a fluid; and wherein once the balloon adheres to the target site, the end effector is configured to cause release of the material from the balloon and onto the target site by applying a force to the tether.

[0023] The distal end of the catheter or sheath may be configured to bend when the distal end of the sheath is distal to the distal-most end of the catheter.

[0024] According to another embodiment, a method of performing a medical procedure includes positioning a catheter adjacent to a target site within a body, advancing a sheath distally along a lumen of the catheter, pushing a balloon containing a material along the lumen, applying an end effector to a distal end of the sheath, expelling the balloon from the distal end of the lumen toward the target site, and releasing the material from the balloon.

[0025] The method may further include attaching the balloon to the target site, and manipulating the end effector away from the target site after the balloon is attached to the target site, thereby causing the balloon to rupture.

[0026] The method may further include actuating the end effector to release the balloon in the body after rupturing the balloon, and moving the sheath proximally to cause the end effector to re-enter the lumen. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] 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.

[0028] Figure 1 is a perspective view of a medical system according to one embodiment;

[0029] Figure 2 According to one embodiment Figure 1 A perspective view of medical tools of a medical system;

[0030] Figures 3 to 5 for Figure 2 A perspective view of a medical tool;

[0031] Figures 6A to 6C According to another embodiment Figure 1 A perspective view of medical tools of a medical system;

[0032] Figure 7A and Figure 7B According to another embodiment Figure 1 A perspective view of medical tools of a medical system;

[0033] Figure 8A and Figure 8B According to another embodiment Figure 1 A perspective view of medical tools of a medical system;

[0034] Figure 9 is a perspective view of an actuating device according to one embodiment. DETAILED DESCRIPTION

[0035] The present disclosure will now be described with reference to an exemplary medical system that can be used to dispense material endoscopically. However, it should be noted that reference to this particular procedure is provided for convenience only and is not intended to limit the present disclosure. Those skilled in the art will recognize that the basic concepts of the disclosed apparatus and application methods can be applied to any suitable procedure, medical or otherwise. The present disclosure may be understood with reference to the following description and accompanying drawings, in which similar elements are designated by the same reference numerals.

[0036] For ease of description, the term "distal" refers to the portion farthest from the user when the system is introduced to the patient. In contrast, the term "proximal" refers to the portion closest to the user when the system is introduced to the 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 apparatus that includes 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 an "example" rather than an "ideal." In this disclosure, relative terms such as, for example, "about," "substantially," "generally," and "approximately" are used to indicate a possible variation of ±10% of a specified value or characteristic.

[0037] refer to Figure 1, shows a medical system 10 according to one embodiment. 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 some other device used to actuate or control the medical system 10, and any tool or device associated with the medical system 10) includes first and second actuation devices 42, 43 that control the articulation of the flexible shaft 20 and / or the articulated joint at the distal end of the flexible shaft 20 in multiple directions. Devices 42, 43 can be, for example, rotatable knobs that rotate about their axes to push / pull an actuation element (not shown). The actuation element, such as a cable or wire suitable for medical procedures (e.g., medical-grade plastic or metal), extends distally from the proximal end of the endoscope 10 and is connected to the flexible shaft 20 to control its movement. Alternatively, or in addition, the user can operate the actuation element independently of the handle 40. The distal ends of the actuation elements extend through the flexible shaft 20 and terminate at an actuation joint and / or distal tip of the flexible shaft 20. For example, one or more actuation elements can be connected to the articulated joint, and actuation of the actuation elements can control movement of the actuation joint or distal tip of the flexible shaft 20 in multiple directions.

[0038] In addition, 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 and may provide electrical control for imaging, lighting, and / or other electrical devices at the distal end of the flexible shaft 20, and may transmit imaging signals from the distal end of the flexible shaft 20 toward the proximal side for processing and / or display on a display. The handle 40 may also include ports 44, 46 for introducing tools, fluids, or other materials and / or removing them from the patient. Port 44 may be used to introduce tools. Port 46 may be connected to the navel for introducing fluids, suction, and / or wiring for electronic components. For example, Figure 1 As shown, port 44 is connected to lumen 22, which extends from the proximal end to the distal end of flexible shaft 20. Port 44 can receive a medical device, such as a flexible sheath 120 of a medical device (eg, a catheter).

[0039] like Figure 1 As shown, the sheath 120 is attached to the distal end of the handle 140. The handle 140 includes a body 142 that defines an aperture 142a at its proximal end. The sheath 120 is attached to the distal end of the body 142, opposite the aperture 142a. The aperture 142a can accommodate a user's thumb (or finger). The handle 140 can be integrally formed with the sheath 120 or otherwise fixedly attached to the sheath 120.

[0040] like Figure 1As further shown, the slot extends through the body 142 in a direction parallel to the longitudinal axis of the sheath 120 and the body 142. A portion of the reel 144 (e.g., a slidable member) is disposed in the slot and is movable within the slot and along the body 142 in a direction parallel to the longitudinal axis. Figure 1 As further shown, reel 144 comprises two circular gripping elements 144a, 144b, each having a hole therethrough, extending transversely to the longitudinal axis from reel 144. Gripping elements 144a, 144b are shown as being 180 degrees apart from each other around the longitudinal axis, but the positioning of gripping elements 144a, 144b is not limited thereto. Gripping elements 144a, 144b are gripped by the user so that reel 144 moves along body 142. For example, the user can place the thumb in hole 142a, the index finger in gripping element 144a, and the middle finger in gripping element 144b, thereby allowing the user to move reel 144 along the longitudinal axis. Wire 132 is connected to the distal end of reel 144 and extends distally therefrom. Wire 132 extends through the hole (not shown) at the distal end of body 142 and extends through the lumen (not shown) of sheath 120. Movement of wire 132 relative to sheath 120 along the longitudinal axis actuates end effector 130, as will be explained herein. Alternatively, wire 132 may be rotatable about a rotation mechanism 143, such as a screw mechanism or any other mechanism known in the art.

[0041] refer to Figures 2 to 4 The catheter 20 includes a plurality of lumens, for example, a first lumen 22, a second lumen 24 (for simplicity of description, only the second lumen 24 is shown in FIG). Figure 1), and a third lumen 26. According to one example, the first lumen 22 is configured to receive a sheath 120 of a medical device, as will be described in greater detail herein. The first lumen 22 extends from the handle 40 and terminates in a first opening 22a at the distal end face 28 of the catheter 20. The second and third lumens 24, 26 can receive additional tools and / or can be used for suction / vacuum, dispensing fluids, imaging, illumination, and the like. For example, the distal openings 24a, 26a of the second and third lumens 24, 26 can be open at the distal end face 28 of the catheter 20. According to one example, the fluid can be discharged through one or both of the openings 24a, 26a after traveling from the handle 40 along the respective second and third lumens 24, 26. Alternatively, debris can be aspirated / vacuumed through one or both of the openings 24a, 26a, and / or an electrical fiber can be disposed in one or both of the second lumen 24 and the third lumen 26 and attached to a visualization component (such as a camera) or illumination member (such as a light emitting diode (LED)) disposed at the openings 24a, 26a. It should be understood that these components can be fixed in the openings 24a, 26a, or the components can extend from the distal end face 28 to provide additional illumination and / or visualization of the target site T.

[0042] Continue to refer Figure 2 , the sheath 120 extends within the first lumen 22 of the catheter 20. The sheath 120 is flexible and has an outer diameter that is 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 end effector 130 at its distal-most end. The end effector 130 includes a pair of jaws that are actuatable between an open position and a closed position. The end effector 130 is configured to grasp the tether 152 of the capsule 150, as shown in FIG. Figure 2 150 and to release the contents from the capsule 150, as will be described herein. It should be understood that the end effector 130 is not limited to this arrangement and can be any end effector suitable for performing a medical treatment at a target site. The end effector 130 can be any suitable end effector used in a medical procedure (such as scissors, graspers, forceps, needles, etc.), or any other therapeutic or diagnostic tool or device, for advancing the capsule 150 to the target site T and releasing the material 160 from the capsule 150, as will be described herein. In an embodiment, the capsule 150 does not include a tether 152 and can be grasped around its periphery. In some embodiments, the capsule 150 can be attached to and / or delivered through one or more hemostat clips, and the material 160 can be released in any manner described herein.

[0043] Figure 3The catheter 20 is shown positioned within the lumen L of the body and adjacent to the target site T. By inserting the catheter 20 through the port 44, the sheath 120 is advanced along the first lumen 22 using the handle 140 to expose the end effector 130 and the balloon 150 from the distal end face 28 of the catheter 20. For example, a user can manipulate the handle 140 to move the sheath 120 distally relative to the catheter 20. This movement causes the end effector 130 to push against the proximal side of the balloon 150, thereby exposing both the balloon 150 and the end effector 130 from the first opening 22a. The handle 140 can be further manipulated to move the balloon 150 adjacent to the target site T. As described herein, the openings 24a, 26a can include lighting and / or visualization elements that can assist in the placement of the balloon 150.

[0044] like Figure 3 As shown, the target site T protrudes into the lumen L. According to one example, the sheath 120 can advance the balloon 150 to the target site T without further actuation or bending of the sheath 120. However, in some examples, the target site T can be located on the side of the lumen L, such as Figure 4 As shown, this requires the end effector 130 to be steered toward the target site T. As discussed above, the catheter 20 may include actuating elements (e.g., cables) extending from the handle 40 to the distal end of the catheter 20. Pulling these cables may cause the end of the catheter 20 to bend, as shown. Figure 4 As shown. Alternatively or additionally, the sheath 120 can be actuated to bend or rotate to enter the target site T. For example, the sheath 120 may include an actuation segment proximate to the end effector 130, which allows the sheath 120 to bend and enter the target site T. The actuation segment may include a shape memory material (e.g., Nitinol) and may be pre-bent to a specific angle so that when the actuation segment is exposed to the lumen L, the shape memory material heats and bends to a preset bending angle. Alternatively, the actuation segment can be actuated using a cable, wire, etc., and the bending angle can be selected by the doctor during the medical procedure. In this way, the doctor can advance the capsule 150 to the target site T.

[0045] like Figure 4 As shown, the sheath 120 manipulates the balloon 150 to the target site T, and the balloon 150 is adjacent to or in contact with the target site T. In some embodiments, the balloon 150 may include an adhesive on the outer surface of the balloon 150, and / or the covering of the balloon 150 may become adhesive due to exposure to mucus or a moist body cavity or due to fluid discharged through the opening 24a or 26a. According to one example, such a balloon 150 can adhere to the target site T with sufficient force to withstand the pulling force on the tether 152, as will be described herein.

[0046] Once the balloon 150 is properly positioned and attached to the target site T, the sheath 120 can be moved away from the target site T to pull the tether 152 and release the material (e.g., powder) 160, such as a medical or therapeutic agent, e.g., Figure 5As shown. For example, the physician can manipulate the handle 140 to move the sheath 120 proximally, thereby moving the end effector 130 away from the target site T and applying pressure to the tether 152, causing the outer wall of the balloon 150 to split or tear. The balloon 150 may include perforations or similar features that weaken at least a portion of the balloon wall, and applying pressure to the tether 152 may cause the weakened portion of the balloon 150 to rupture. The balloon 150 may also include two sides of approximately equal size that are bonded together (e.g., via a friction fit, adhesive, heat-set, etc.), and applying pressure to the tether 152 may cause the two sides to pull apart. The tether 152 may also be attached to a plug that fits into a corresponding hole in the balloon 150, such that applying force to the tether 152 causes the plug to be removed from the hole. According to another example, the tether 152 may be woven from overlapping flaps in the balloon 150, and applying pressure to the tether 152 may damage the seal. Once the seal or wall of the balloon 150 is broken, the material 160 may exit the balloon 150. Alternatively or additionally, the physician may cause the distal actuation section of the sheath 120 to bend in other ways and move the end effector 130 away from the target site T. As the end effector 130 moves away from the target site T, adhesive forces acting on the balloon 150 cause the balloon 150 to remain adhered to the target site T, thereby causing the tether 152 to break or create a tear in the balloon 150 and release the powder 160. The powder 160 may be a hemostatic agent and may cause bleeding at the target site T to clot. Alternatively or additionally, the powder 160 may include antimicrobial and / or other beneficial medical properties to promote healing and / or other therapeutic benefits at the target site T. After deploying the powder 160, the end effector 130 can be retracted into the lumen 22 along with the remainder of the ruptured balloon 150. Alternatively, the physician can cause the jaws of the end effector 130 to open to release the tether 152 and allow the balloon 150 to remain in the body to decompose and / or be excreted via natural bodily excretion pathways. It should be understood that the element comprising the powder is not limited to the balloon 150. For example, the balloon 150 can be any container suitable for containing the powder 160, including but not limited to a spherical or other shaped body having an outer protective layer surrounding the powder 160. Alternatively, the balloon 150 may not include an outer covering and may be an agglomeration of the powder 160 (such as a mass of powder or other material held together by an adhesive or other chemical bond) that breaks apart upon exposure to a fluid. It should also be understood that the capsule 150 may include compartments to include different types of materials; these different types of materials, once exposed to each other, react to form a homogeneous material having properties that cause the material to adhere to the target site T and / or include therapeutic properties, such as a hemostatic agent.

[0047] In this way, a target site that may be difficult to access (such as a site on the top surface (apex) of the gastrointestinal lumen) can have a therapeutic powder applied to it. Otherwise, due to the gravity applied to such powder, it may be more difficult to apply the powdered medicament to the target site. It should be understood that although the catheter 20 is advanced to the target site T and the sheath 120 is advanced along the first lumen 22 to the target site T, the catheter 20 does not need to deploy the balloon 150. For example, the sheath 120 (including the end effector 130 attached to the balloon 150 via the tether 152) can be advanced along the body cavity to the target site T without the use of the catheter 20.

[0048] A method of administering therapeutic powder 160 will now be described.

[0049] The catheter 20 is inserted into the body through a natural orifice or incision of the patient. The catheter 20 is advanced along the body cavity to the target site T. Once the catheter 20 is advanced to the target site T, the sheath 120 is inserted into the port 44 and advanced along the first lumen 22. It should be understood that the sheath 120 can be inserted into the port 44 before the start of the procedure, for example, before the catheter 20 is inserted into the body; and the sheath 120 can be advanced to the target site T simultaneously with the catheter 20.

[0050] For example, the balloon 150 can be inserted into the port 44 before the distal end of the sheath 120, or the end effector 130 can grasp the tether 152 before inserting the distal ends of the balloon 150 and sheath 120. Once the balloon 150 and sheath 120 are both inserted into the port 44, the sheath 120 is advanced distally toward the distal end of the catheter 20. As the sheath 120 is advanced distally, the end effector 130 pushes the proximal end of the balloon 150, causing the balloon 150 to advance through the lumen 22 of the catheter 20. In an embodiment in which the sheath 120 is inserted into the body without the catheter 20, the balloon 150 can also be moved to the target site T in a similar manner. Alternatively, as the sheath 120 is advanced distally toward the target site T, the end effector 130 can pull the balloon 150 along the body lumen L.

[0051] After the catheter 20 and sheath 120 are positioned adjacent to the target site T, the handle 140 is manipulated to move the sheath 120 in a distal direction relative to the catheter 20 along the first lumen 22. Moving the sheath 120 in the distal direction forces the end effector 130 against the proximal side of the balloon 150 and out of the first opening 22a in the distal end face 28.

[0052] After the balloon 150 is outside the first lumen 22, the sheath 120 is manipulated to urge the balloon 150 against the target site T. According to one example, urging the balloon 150 against the target site T may include bending the distal end of the catheter 20 and / or bending a hinged section of the sheath 120. In some examples, urging the balloon 150 against the target site T includes dispensing fluid from the opening 24a or 26a to wet the balloon and activate an adhesive material on an exterior surface of the balloon 150.

[0053] Once the balloon 150 is adhered to the target site T, the sheath 120 is moved away from the target site T by moving the sheath 120 proximally. Alternatively, the end effector 130 may grasp the balloon 150 between a pair of jaws. The jaws of the end effector 130 may be actuated to increase pressure on the balloon 150, thereby breaking apart the outer shell of the balloon 150 and causing the powder 160 to be dispersed at the target site T. The sheath 120 is then retracted into the lumen 22, and the catheter 20 may be removed from the body cavity. According to another example, before the sheath 120 is retracted into the lumen 22, the tether 152 may be released by pushing the reel 144 distally and opening the jaws of the end effector 130. In an example where the balloon 150 is dissolvable due to interaction with a liquid, flushing may be used to dissolve the balloon 150 and release the agent 160.

[0054] The distal end of the medical system 10 according to another example is shown in FIG. Figures 6A to 6C Similar elements are denoted by similar reference numerals.

[0055] like Figure 6A As shown and similar to the sheath 120 described above, the sheath 220 extends through the lumen 22 of the catheter 20. The sheath 220 includes an end effector 230 at its distal-most end. Figure 6B As shown, the end effector 230 is umbrella-shaped in the deployed position such that the distal-most end of the end effector 230 has a larger diameter than the proximal-most end of the end effector 230. The end effector 230 may be formed of a shape memory material, such as Nitinol. When the end effector 230 is exposed to the lumen L, the heat of the patient's body may increase the temperature of the end effector 230, thereby causing the shape of the end effector to change from a contracted shape to an umbrella shape. Alternatively, the end effector 230 may include a collapsible structure that forms a collapsed or folded orientation when disposed in the lumen 22 and forms a collapsed or folded orientation when exposed from the lumen 22. Figure 6B and Figure 6C Umbrella shape shown. Such collapsible structures can be formed from sheets of flexible material.

[0056] refer to Figure 6A, the end effector 230 collapses when disposed within the lumen 22. The end effector 230 is configured to push a balloon 250 (similar to balloon 150) out of the first opening 22a in the distal end face 28. The outer shell of the balloon 250 begins to degrade upon exposure to moisture (such as the mucous membrane of the lumen L) or when fluid is sprayed from the openings 24a, 26a. Figure 6B The release of powder 260 from capsule 250 is shown after the outer shell of capsule 250 has dissolved.

[0057] refer to Figure 6B and Figure 6C , the end effector 230 captures or coralizes the powder 260 on the inner distal surface of the umbrella-shaped end effector 230. According to one example, the end effector 230 captures or coralizes the capsule 250 before the capsule 250 is completely dissolved, thereby allowing a larger amount of powder 260 to be captured by the end effector 230 and suspended in the body cavity L. Alternatively, the end effector 230 may capture the powder 260 when the powder 260 is not disposed in the capsule 230.

[0058] like Figure 6C As shown, the sheath 220 may include an articulating section 222 (similar to the articulating sections described above) to allow a medical professional to manipulate the end effector 230 to access the target site T. The end effector 230 may also be manipulated in any manner discussed above with respect to the end effector 130 to bend toward the target site T. For example, the medical professional manipulates the end effector 230 toward the target site T so that the inner distal surface of the end effector 230 faces the target site T to direct the powder 260 onto the target site T. The end effector 230 presses against the target site 260, thereby applying pressure to the powder 260 at the target site T. To maximize the effect of the powder 260 on the target site T, the position of the end effector 230 against the target site T may be maintained for a predetermined amount of time. In this way, the amount of powder 260 dispensed at the target site T may be minimized while still maximizing the effect of the powder 260.

[0059] The operation of the sheath 220 will now be described.

[0060] As discussed above, the balloon 250 can be inserted through the port 44, and the distal end of the sheath 220 can then be inserted through the port 44. As with the sheath 120, the sheath 220 is pushed distally along the lumen 22 using the handle 140. The end effector 230 pushes against the proximal end of the balloon 250 to advance the balloon 250 to the distal end of the catheter 20, causing the end effector 230 and the balloon 250 to exit the first opening 22a.

[0061] As the balloon 250 exits the lumen 22, the medical professional can cause fluid to be ejected from the opening 24a or the opening 26a to cause the outer covering of the balloon 250 to begin to dissolve or completely dissolve. Alternatively, as discussed above, the balloon 250 can dissolve based on moisture already present in the lumen L. Simultaneously or subsequently, as the end effector 230 exits the lumen 22 through the opening 22a, the end effector 230 expands from the collapsed shape to the expanded umbrella shape, as a result of the physical properties of the material forming the end effector 230 or via actuation of an actuation cable or other actuation mechanism (not shown) for expanding the end effector 230. Figure 6B shown.

[0062] Subsequently, the sheath 220 is manipulated to capture the partially dissolved capsule 250 and / or powder 260. The sheath 220 is then manipulated so that the distal surface of the end effector 230 faces the target site T via, for example, the articulated section 222, and the interior distal surface of the end effector 230 is pressed toward the target site T, thereby allowing the powder 260 to coat the target site T. The distal surface of the end effector 230 can then be placed in contact with the target site T (and the powder 260 coating the target site T) and press the target site T. After a predetermined period of time has elapsed, the sheath 220 is moved proximally, causing the end effector 230 to move into the lumen 22 and collapse into a low-profile shape.

[0063] The distal end of the medical system 10 according to another example is shown in FIG. Figure 7A and Figure 7B End effector 330 has the same umbrella shape as end effector 230 and may be formed from the same or similar materials and deployed in the same manner as end effector 230, as described above.

[0064] like Figure 7A As shown, the sheath 320 can be manipulated to access the target site T in any manner described above with respect to the sheaths 120, 220, including but not limited to the curved catheter 20 and / or the curved sheath 330. The sheath 320 includes a central lumen 324 that extends from the handle 40 to the interior of the end effector 330 and terminates at a central opening 324a. Figure 7BAs shown, the end effector 330 extends from the first opening 22a and faces and surrounds the target site T. A capsule (not shown) containing powder 360, or powder 360 without a capsule, is delivered downward from the central lumen 324 to the target site T using any dispensing device known in the art. For example, a propellant fluid (such as CO2) can force the capsule or powder 360 from a container, attached to the proximal end of the catheter 20 via the handle 40, down the central lumen 324 and out of the central opening 324a. The outer diameter of the distal-most end of the end effector 330 defines the area in which the capsule or powder 360 is dispensed to the target site T. For example, the end effector 330 can press against the target site T to form a partial or complete seal between the inner distal surface of the end effector 330 and the wall of the lumen L. In this way, delivery of the powder 360 can be directly targeted to the target site T while minimizing the amount of powder released outside the target site T.

[0065] The operation of sheath 320 will now be described.

[0066] The sheath 320 is pushed distally along the lumen 22 using the handle 140. The end effector 330 exits the first opening 22a and expands in a similar manner to the end effector 230, e.g., based on the physical properties of the material forming the end effector 330 or via actuation of an actuation cable (not shown) to expand the end effector 330.

[0067] After the end effector 330 is exposed from the first opening 22a, the end effector 330 is manipulated to cover the target site T, such as Figure 7B . For example, the outer periphery of the distal-most end of the end effector 330 is placed against the lumen wall LW of the lumen L and / or against the target site T. In some examples, the outer periphery of the distal-most end of the end effector 330 completely surrounds the target site T. In other embodiments, the target site T may be larger and / or may have a shape that is not completely surrounded by the outer periphery of the distal-most end of the end effector 330. Although the target site T is shown as being generally parallel to the distal end face 28, the target site T may be angled relative to the target site T, for example, generally perpendicular. Thus, the distal end of the sheath 320 can be articulated in a manner similar to the articulation of the articulation section 222 disclosed herein to access the target site T.

[0068] Once the end effector 330 is positioned with respect to the target site T, a powder 360 (e.g., a fluidized powder), a capsule, or some other delivery mechanism containing a therapeutic agent is delivered from the proximal end of the sheath 320 to the end effector 330 along the central lumen 324. The powder is discharged from the central lumen 324 via the central opening 324a. The dispersion of the powder 360 is limited to the target site T surrounded by the outer periphery of the end effector 330. Once the powder 360 (delivered via, for example, a fluidized powder, a capsule, etc.) contacts the target site T, the powder 360 adheres via moisture from the mucosa and / or moisture from the fluid, which may be ejected via the central lumen 324 and / or the openings 24a, 26a. It should be understood that the powder 360 may be delivered by any actuating device (e.g., by Figure 9 An actuation device 540 , as shown and discussed in greater detail herein, or any other known delivery mechanism, is conveyed along the central lumen 324 .

[0069] Another example of a sheath 420 for deploying therapeutic material is shown in FIG. Figure 8A and Figure 8B In. Figure 8A As shown, sheath 420 includes an end effector 430 having a die or press-like shape. The shape of end effector 430 can be cylindrical or disc-shaped. End effector 430 has a flat or substantially flat distal-most end having a larger circumference than the proximal-most ends of end effector 430 and sheath 420; and this proximal-most end is connected to the distal-most end of sheath 420. It should be understood that the shape is not limited to a die or press-like shape, and the shape of end effector 430 can include a shape that facilitates the capture of capsules or powders, as described herein.

[0070] Balloon (450) is located distal to end effector (430) within lumen (22). Figure 8AThe first opening 22a of the catheter 20 includes a ring 22b to reduce the size of the first opening 22a relative to the cross-sectional size or diameter of the lumen 22. In some embodiments, the ring 22b includes teeth 24 or other sharp structures, such as hooks or barbs, located on the proximal side of the ring 22b or extending radially inward from the inner circumference of the ring 22b. The outer diameter of the capsule 450 is greater than the diameter of the first opening 22a. As the sheath 430 moves distally relative to the catheter 20, the end effector 430 pushes against the proximal side of the capsule 450, and the capsule 450 compresses the ring 22b. The force of the capsule 450 compressing the ring 22b (and, in some embodiments, the teeth 24 or other sharp structures) causes the capsule 450 to rupture, thereby releasing the powder 460. The opening 22a includes an inner diameter greater than the outer diameter of the end effector 430, so that as the sheath 420 continues to move distally, the end effector 430 is exposed from the lumen 22 via the opening 22a. Powder 460 coats the distal-most surface of the end effector 430, and as with other embodiments described herein, the sheath 420 can be maneuvered toward the target site T, such as through the curved section 422. The powder 460 can adhere to the target site T when exposed to moisture within the lumen L or when exposed to fluid ejected from the openings 24a, 26a. The position of the end effector 430 relative to the target site T, and the pressure applied to the target site T by the end effector 430, can be maintained for a predetermined period of time to ensure that the appropriate amount of powder adheres to the treatment site T and is effective, for example, to stop bleeding. It should be understood that the ring 22b and teeth 24 can be used in any of the sheaths described herein to facilitate rupturing the capsule to expose and deliver the material or powder disposed therein. Furthermore, in some embodiments, the sharp features are absent from the ring 22b, and forcing the capsule 450 through the smaller diameter opening 22a will rupture the capsule 450 to disperse the powder 460.

[0071] The operation of sheath 420 will now be described.

[0072] As with other sheaths described herein, the capsule 450 is inserted through the port 44 before the distal end of the sheath 420 is inserted into the port 44. The sheath 420 is pushed distally along the lumen 22 using the handle 140, which causes the end effector 430 to push against the proximal end of the capsule 450, thereby causing the end effector 430 and the capsule to approach the first opening 22a. As the capsule 450 and end effector 430 approach the first opening 22a, the distal end of the capsule 450 contacts the surface of the ring 22b that faces the interior of the lumen 22 and / or the teeth 24 or other sharp structures disposed on the inner surface or inner circumference of the ring 22b. The force of the end effector 430 against the proximal end of the capsule 450 and the force of the ring 22b and / or teeth 24 against the distal end of the capsule 450 causes the capsule 450 to rupture, thereby expelling the powder 460.

[0073] The user continues to push the sheath 420 distally, causing the powder 460 to contact the distal-most end of the end effector 430. The sheath 420 is then manipulated in any manner described herein to face the target site T (e.g., via articulation of the articulation section 422), thereby pressing the end effector 430 toward the target site T. The end effector 430 compacts or pushes the powder 460 against the target site T. The powder 460 can be activated by moisture, for example, mucosal fluid at the target site T and / or fluid sprayed through the openings 24a, 26a. After a predetermined period of time has elapsed, the sheath 420 is moved proximally, causing the end effector 430 to move back into the lumen 22.

[0074] An actuator 540 for dispensing powder and / or capsules 550 is shown in FIG. Figure 9 The actuator 540 includes a body 542 having a pistol-shaped grip and a trigger mechanism 546. A fluid connector 544 connects the actuator 540 to a pressurized fluid source 570, such as CO2, via a hose 572 (e.g., a flexible hose). The fluid source 570 can be a pressurized fluid source found in a hospital, or it can be a device that is directly attached to the actuator 540, allowing the actuator 540 to be portable.

[0075] Fluid connector 544 connects to internal chamber 548, which may include capsule 550 or powder not contained within the capsule. Capsule 550 may be added separately, or a hopper or other container (not shown) may be attached to actuation device 540 to supply the capsule or powder to internal chamber 548. A catheter connector 549 connects catheter 520 having lumen 522 to body 542. Upon actuation of trigger mechanism 546, propellant fluid (e.g., CO2) is released from pressurized fluid source 570 and can be transferred distally from lumen 522 downward to an outlet (not shown) at the distal end of catheter 520. According to one example, the amount of gas released may be approximately 16 liters or less, e.g., the amount of gas (e.g., CO2) stored in two standard cartridges at a pressure of approximately 1 to 10 standard liters per minute (SLPM), or approximately 5 SLPM. This amount of propellant gas is sufficient to transport balloon 550 along lumen 522 and is also a safe amount of propellant fluid to deliver to the body (insufflation).

[0076] The operation of the actuating device 540 will now be described.

[0077] The capsule 550 is loaded into the internal chamber 548. The catheter 520 is introduced into the body via a natural orifice or incision and advanced to the target site. Once the distal end of the catheter 520 is positioned adjacent to the target site, the user activates the trigger mechanism 546, causing the propellant fluid to leave the fluid source 570 and enter the internal chamber 548. The propellant fluid causes the capsule 550 to advance distally from the internal chamber 548 via the catheter 520 to the target tissue. The propellant fluid is sufficient to transport the capsule 550 along the lumen 520 while being a safe amount of propellant fluid to be introduced into the body (insufflation). Additional capsules 550 can be delivered to the same or different target sites until the treatment is complete, at which point the catheter 520 is removed from the body.

[0078] It will be apparent to those skilled in the art that various modifications and variations may be made to the disclosed device without departing from the scope of the present disclosure. For example, any material or fluid may be contained in the capsule and / or delivered in powder form to be discharged from the administration device to the target location, including but not limited to materials having a therapeutic effect. Additionally or alternatively, unless otherwise provided, the medical devices described herein may be formed of any metal, alloy, plastic, or ceramic suitable for medical applications, or any combination thereof. 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 contemplated that the description and examples should be regarded as exemplary only, with the true scope and spirit of the invention being indicated by the following claims.

Claims

1. A medical system comprising: handle; a sheath extending from the handle; an end effector coupled to the distal end of the sheath; and a capsule containing a material, wherein the capsule includes a tether configured to be grasped by the end effector, wherein the end effector is configured to direct the balloon toward a target site in the body, and Wherein the end effector is configured to open the balloon and cause release of the material onto the target site by applying a force to the tether.

2. The medical system of claim 1 , further comprising a catheter comprising a catheter lumen, wherein the sheath is configured to extend through the catheter lumen, and wherein the catheter further comprises a fluid lumen fluidly isolated from the catheter lumen, wherein the fluid lumen is configured to attach to a fluid source and dispense fluid from a fluid opening at a distal end of the catheter. 3 . The medical system of claim 2 , wherein the end effector is configured to advance the balloon along the catheter lumen and to the target site through the lumen opening at the distal end of the catheter.

4. The medical system of claim 3, wherein the end effector comprises a pair of jaws, and wherein the tether is configured to be grasped by the pair of jaws.

5. The medical system of claim 4, wherein the end effector is configured to pull the tether proximally to open the balloon.

6. The medical system of any one of claims 1 to 5, wherein the outer covering of the balloon comprises a material configured to adhere to the target site when exposed to a fluid.

7. The medical system of any one of claims 1 to 5, wherein the outer covering of the balloon comprises a material that dissolves when exposed to fluid.

8. The medical system of claim 2, wherein the diameter of the distal opening of the catheter lumen is smaller than the diameter of the balloon.

9. The medical system of claim 8, wherein the distal end of the catheter lumen includes a protrusion extending from a wall of the catheter lumen toward a central longitudinal axis of the catheter, the protrusion configured to rupture the balloon.

10. The medical system of claim 2, wherein the diameter of the end effector is smaller than the diameter of the distal opening of the catheter lumen, and wherein the end effector is configured to extend out of the catheter lumen and extend distally of the distal-most end of the catheter.

11. The medical system of any one of claims 1 to 5, wherein the material is at least one of a hemostatic agent or a therapeutic agent.

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