Medical delivery device

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 mass of material towards a target site of the body and causes release of the material onto the target site.

Description

Cross Reference to Related Applications

[0001] This application claims priority to U.S. Provisional Application No. 62 / 942,919, filed December 3, 2019, which is incorporated by reference herein in its entirety. TECHNICAL FIELD

[0002] The present disclosure relates generally 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

[0003] In certain medical procedures, it can be desirable to stop or minimize bleeding inside the body. For example, endoscopic medical procedures can require hemostasis of bleeding tissue within the gastrointestinal tract, such as the esophagus, stomach, or intestines.

[0004] During an endoscopic procedure, a user inserts a sheath of an endoscope into a body cavity of a patient. The user controls the endoscope during the procedure with a handle of the endoscope. Tools are passed through a working channel of the endoscope, via a port in the handle, for example, to deliver a treatment at a procedure site near a distal end of the endoscope. The procedure site is remote from the operator.

[0005] To achieve hemostasis at the remote site, a hemostatic agent can be delivered by a device that is inserted into the working channel of the endoscope. For example, agent delivery can be achieved by a mechanical system. However, such systems can not achieve a desired rate of agent delivery or a desired dose of agent, can result in inconsistent doses of agent, or can result in agent not reaching a treatment site deep within the gastrointestinal tract. The present disclosure can address one or more of these or other problems of the prior art. SUMMARY

[0006] According to one embodiment, a medical system includes a handle, a sheath extending from the handle, and an end effector coupled to a distal end of the sheath, wherein the end effector is configured to direct a quantity of material toward a target site of a body and to cause release of the material onto the target site.

[0007] The medical system can include a catheter including a catheter lumen, wherein the sheath can be configured to extend through the catheter lumen, and wherein the catheter can further include a fluid lumen fluidically decoupled from the catheter lumen, wherein the fluid lumen can be configured to be attached to a fluid source and to dispense fluid from a fluid opening at a distal end of the catheter.

[0008] The medical system can further include a capsule containing the quantity of material, wherein the end effector can be configured to advance the capsule along the catheter lumen and to advance to the target site via a lumen opening at the distal end of the catheter.

[0009] The end effector may include a pair of jaws, and the bladder may include a tether configured to be gripped by the pair of jaws.

[0010] The end effector can be configured as a traction tether to open the bladder.

[0011] The outer covering of the capsule may include a material configured to adhere to the target site when exposed to fluid.

[0012] The outer covering of the capsule may include a material that dissolves when in contact with a fluid.

[0013] The end effector can be configured to move from a collapsed state to an expanded state, wherein the end effector can have an umbrella-like shape in the expanded state, such that the diameter of the distal end of the end effector can be larger than the diameter of the proximal end of the end effector.

[0014] The catheter may include a capsule within the catheter lumen.

[0015] The end effector may include 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 state to an expanded state when the temperature exceeds a temperature threshold.

[0016] The catheter may include a capsule containing a large amount of material, wherein the diameter of the distal opening of the catheter lumen may be smaller than the diameter of the capsule.

[0017] The distal end of the catheter lumen may include a protrusion that extends from the wall of the catheter lumen toward the central longitudinal axis of the catheter, the protrusion being configured to rupture the cyst.

[0018] The diameter of the end effector may be smaller than the diameter of the distal opening of the catheter lumen, and the end effector may be configured to extend away from the catheter lumen and extend to the distal end of the catheter.

[0019] The end effector may have a disc-shaped distal surface for applying pressure to the material at the target location.

[0020] The materials can be hemostatic agents or therapeutic agents.

[0021] According to another embodiment, the medical system includes an actuating stem, a sheath, a catheter, a sac, and an end effector; the sheath extends from a distal end of the stem, the catheter includes a catheter lumen, and the sheath is configured to extend through the catheter lumen; the sac contains material, and the sac includes a tether; the end effector is connected to a distal end of the sheath and configured to grasp the tether; wherein the end effector is configured to advance the sac along the catheter lumen and through a catheter lumen opening at the distal end of the catheter to a target site; wherein an outer portion of the sac includes material configured to adhere to the target site when exposed to fluid; and wherein once the sac adheres to the target site, the end effector is configured to release the material from the sac to the target site by applying force to the tether.

[0022] 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 end of the catheter.

[0023] According to another embodiment, a method of performing a medical procedure includes positioning a catheter adjacent to a target site within the body, advancing a sheath distally along the lumen of the catheter, pushing a capsule containing material along the lumen, applying an end effector to the distal end of the sheath, discharging the capsule from the distal end of the lumen toward the target site, and releasing material from the capsule.

[0024] The method may also include attaching the capsule to the target site and, after the capsule is attached to the target site, manipulating the end effector away from the target site to cause the capsule to rupture.

[0025] The method may also include actuating the end effector to release the bladder into the body after bladder rupture, and moving the sheath proximally to cause the end effector to re-enter the lumen. Attached Figure Description

[0026] 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.

[0027] Figure 1 A perspective view of a medical system according to one embodiment;

[0028] Figure 2 According to one embodiment Figure 1 A perspective view of medical tools in the healthcare system;

[0029] Figures 3 to 5 for Figure 2 A perspective view of medical tools;

[0030] Figures 6A to 6C According to another embodiment Figure 1 A perspective view of medical tools in the healthcare system;

[0031] Figure 7A and Figure 7B According to another embodiment Figure 1 A perspective view of medical tools in the healthcare system;

[0032] Figure 8A and Figure 8B According to another embodiment Figure 1 A perspective view of medical tools in the healthcare system;

[0033] Figure 9 This is a perspective view of an actuator according to one embodiment. Detailed Implementation

[0034] This disclosure is now described with reference to an exemplary medical system that can be used for endoscopic material dispensing. However, it should be noted that references to this particular procedure are provided for convenience only and are not intended to limit the scope of this disclosure. Those skilled in the art will recognize that the basic ideas of the disclosed apparatus and application methods can be used in any suitable procedure, medical or otherwise. This disclosure may be understood with reference to the following description and accompanying drawings, wherein similar elements are referred to by the same reference numerals.

[0035] For the sake of simplicity, when introducing the system to a patient, the term "distal" refers to the part furthest from the user. In contrast, when introducing the system to a patient, the term "proximal" refers to the part closest to the user. As used herein, the terms "comprises," "comprising," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that includes a list of elements does not necessarily include only those elements, and may include other elements not expressly listed or inherent to such process, method, article, or apparatus. The term "exemplary" is used in the sense of "example" rather than "ideal." In this disclosure, relative terms (such as, for example, "about," "comprehensive," "general," and "approximately") are used to indicate possible variations of ±10% in a specified value or characteristic.

[0036] refer to Figure 1The image illustrates 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 at the proximal end of the flexible shaft 20. The handle 40 (or some other means for actuating or controlling the medical system 10, and any tool or device associated with the medical system 10) includes first and second actuating devices 42, 43 that control the hinge of the flexible shaft 20 and / or the hinge joint at the distal end of the flexible shaft 20 in multiple directions. Devices 42, 43 may be, for example, rotatable knobs that rotate about their axes to push / pull an actuating element (not shown). An actuating 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 connects to the flexible shaft 20 to control its movement. Alternatively or additionally, the user can operate the actuating element independently of the handle 40. The distal end of the actuating element extends through the flexible shaft 20 and terminates at the actuating joint and / or distal end of the flexible shaft 20. For example, one or more actuating elements may be connected to the articulated joint, and actuation of the actuating elements may control the movement of the actuating joint or distal end of the flexible shaft 20 in multiple directions.

[0037] 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, illumination, 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 proximally for processing and / or display on a monitor. 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 for introducing tools. Port 46 may be connected to the navel for wiring to introduce fluids, suction, and / or electronic components. For example, as... 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 may receive a medical device, such as the flexible sheath 120 of the medical device (e.g., a catheter).

[0038] 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 accommodates a user's thumb (or finger). The handle 140 may be integrally formed with the sheath 120 or otherwise fixedly attached to the sheath 120.

[0039] 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 spool 144 (e.g., a sliding 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, the reel 144 includes two circular gripping elements 144a and 144b, each having a through hole extending transversely to the longitudinal axis from the reel 144. The gripping elements 144a and 144b are shown separated from each other by 180 degrees about the longitudinal axis, but their positioning is not limited thereto. The gripping elements 144a and 144b are gripped by a user to move the reel 144 along the body 142. For example, the user can place their thumb in hole 142a, their index finger in gripping element 144a, and their middle finger in gripping element 144b, thereby allowing the user to move the reel 144 along the longitudinal axis. A cable 132 is connected to and extends distally from the reel 144. The cable 132 extends through a hole (not shown) at the distal end of the body 142 and through a lumen (not shown) of the 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 rotating mechanism 143 (such as a screw mechanism or any other mechanism known in the art).

[0040] refer to Figures 2 to 4 The catheter 20 includes multiple lumens, such as a first lumen 22 and a second lumen 24 (for simplicity, only the second lumen 24 is shown). Figure 1The first lumen 24 and the third lumen 26 are respectively the first lumen 24 and the third lumen 26. According to one example, the first lumen 22 is configured to receive a sheath 120 for a medical device, as will be described in more detail herein. The first lumen 22 extends from the handle 40 and terminates at a first opening 22a at the distal end face 28 of the catheter 20. The second lumen 24 and the third lumen 26 may receive additional tools and / or be used for aspiration / vacuuming, fluid dispensing, imaging, illumination, etc. For example, the distal openings 24a, 26a of the second lumen 24 and the third lumen 26 may be open at the distal end face 28 of the catheter 20. According to one example, fluid may be discharged through one or both of the openings 24a, 26a after traveling from the handle 40 along the respective second lumen 24 and third lumen 26. Alternatively, debris may be suctioned / vacuumed through one or both of openings 24a and 26a, and / or electrical fibers may be disposed in one or both of the second cavity 24 and the third cavity 26 and attached to a visualization component (such as a camera) or an illumination component (such as a light-emitting diode (LED)) disposed at openings 24a and 26a. It should be understood that these components may be fixed in openings 24a and 26a, or the components may extend from the distal end face 28 to provide additional illumination and / or visualization of the target site T.

[0041] Continue to refer to 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 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 end. The end effector 130 includes a pair of jaws actuable between an open position and a closed position. The end effector 130 is configured to grasp the tethering element 152 of the bladder body 150, such as... Figure 2 As shown, the capsule 150 is manipulated and its contents are released 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 may be any end effector suitable for performing medical procedures at a target site. The end effector 130 may be any suitable end effector for medical procedures (such as scissors, grippers, forceps, needles, etc.), or any other therapeutic or diagnostic tool or device, for advancing the capsule 150 to the target site T and releasing material 160 from the capsule 150, as will be described herein. In embodiments, the capsule 150 does not include a tether 152 and may be gripped around its periphery. In some embodiments, the capsule 150 may be attached to and / or delivered via one or more hemostatic clips, and the material 160 may be released in any manner described herein.

[0042] Figure 3A catheter 20 is shown disposed within the lumen L of the body and adjacent to the target site T. By inserting the catheter 20 through port 44, a sheath 120 is advanced along the first lumen 22 using a handle 140 to expose the end effector 130 and the capsule 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 capsule 150, thereby exposing both the capsule 150 and the end effector 130 from the first opening 22a. The handle 140 can be further manipulated to move the capsule 150 adjacent to the target site T. As described herein, openings 24a, 26a may include lighting and / or visualization elements that may assist in the placement of the capsule 150.

[0043] like Figure 3 As shown, the target portion T protrudes into the lumen L. According to one example, the sheath 120 can advance the capsule 150 to the target portion T without further actuation or bending of the sheath 120. However, in some examples, the target portion T may be located on the side of the lumen L, such as... Figure 4 As shown, this requires the end effector 130 to maneuver toward the target site T. As discussed above, the conduit 20 may include actuating elements (e.g., cables) extending from the shank 40 to the distal end of the conduit 20. Pulling these cables can bend the end of the conduit 20, as... Figure 4 As shown. Alternatively or additionally, the sheath 120 may be actuated to bend or rotate to enter the target site T. For example, the sheath 120 may include an actuating section adjacent to the end effector 130, which allows the sheath 120 to bend and enter the target site T. The actuating section may include a shape memory material (e.g., nitinol) and may be pre-bent to a specific angle such that when the actuating section is exposed to the lumen L, the shape memory material heats up and bends to a preset bending angle. Alternatively, the actuating section may be actuated using cables, wires, etc., and the bending angle may be selected by the physician during the medical procedure. In this way, the physician can advance the capsule 150 to the target site T.

[0044] like Figure 4 As shown, the sheath 120 maneuvers the bladder 150 to the target site T, and the bladder 150 is adjacent to or in contact with the target site T. In some embodiments, the bladder 150 may include an adhesive on the outer surface of the bladder 150, and / or the covering of the bladder 150 may become adhesive due to exposure to mucus or wetting of the body cavity or due to fluid drained through openings 24a or 26a. According to one example, such a bladder 150 can adhere to the target site T with sufficient force to withstand the tensile force on the tether 152, as will be described herein.

[0045] Once the capsule 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 material (e.g., powder) 160, such as a medical agent or therapeutic agent, such as... Figure 5As shown. For example, a 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 capsule 150 to split or tear. The capsule 150 may include perforations or similar features that weaken at least a portion of the capsule wall, and applying pressure to the tether 152 can cause the weakened portion of the capsule 150 to rupture. The capsule 150 may also include two nearly equal-sized sides joined together (e.g., via friction fit, adhesive, thermal bonding, etc.), and applying pressure to the tether 152 can cause these two sides to pull apart. The tether 152 may also be attached to a plug that fits into a corresponding hole in the capsule 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 through overlapping flaps in the capsule 150, and applying pressure to the tether 152 may damage the seal. Once the seal or wall of the capsule 150 ruptures, material 160 may detach from the capsule 150. Alternatively or additionally, a physician may cause the distal actuating segment 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 capsule 150 cause the capsule 150 to remain adhered to the target site T, thereby causing the tether 152 to rupture or creating a tear in the capsule 150 and releasing powder 160. Powder 160 may be a hemostatic agent and may cause the bleeding at the target site T to coagulate. Alternatively or additionally, powder 160 may include antibacterial and / or other beneficial medical properties to promote healing at the target site T and / or other therapeutic benefits. After the powder 160 is deployed, the end effector 130 may retract into the lumen 22 along with the remainder of the ruptured cyst 150. Alternatively, a physician may cause the pawls of the end effector 130 to open to release the tether 152, allowing the cyst 150 to remain in the body for breakdown and / or elimination via natural bodily excretion pathways. It should be understood that the element including the powder is not limited to the cyst 150. For example, the cyst 150 may 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 cyst 150 may not include an outer covering and may be an agglomeration of the powder 160 (such as a large amount of powder or other material held together by adhesives or other chemical bonds) that breaks apart upon exposure to 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 hemostatic agents.

[0046] In this way, target sites that may be difficult to access (such as the top surface of the gastrointestinal lumen) can have the therapeutic powder applied thereto. Otherwise, the powdered agent could be even more difficult to apply to the target site due to gravity applied to such powder. It should be understood that although catheter 20 is advanced to the target site T and sheath 120 is advanced along the first lumen 22 to the target site T, catheter 20 does not need to deploy capsule 150. For example, sheath 120 (including end actuator 130 attached to capsule 150 via tether 152) can be advanced along the body cavity to the target site T without the use of catheter 20.

[0047] A method for applying therapeutic powder 160 will now be described.

[0048] The catheter 20 is inserted into the body through the patient's natural orifice or incision. The catheter 20 is advanced along the body cavity to the target site T. Once the catheter 20 has been 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 may 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 may be advanced to the target site T simultaneously with the catheter 20.

[0049] For example, the capsule 150 may be inserted into the port 44 before the distal end of the sheath 120, or the end effector 130 may grasp the tether 152 before the distal ends of the capsule 150 and sheath 120 are inserted. Once both the capsule 150 and sheath 120 are 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 capsule 150, thereby causing the capsule 150 to advance through the lumen 22 of the catheter 20. In one embodiment in which the sheath 120 is inserted into the body without the catheter 20, the capsule 150 may 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 may pull the capsule 150 along the body cavity L.

[0050] After positioning the catheter 20 and sheath 120 adjacent to the target site T, the handle 140 is manipulated to move the sheath 120 along the first lumen 22 in a distal direction relative to the catheter 20. This distal movement of the sheath 120 forces the end effector 130 against the proximal side of the capsule 150 and away from the first opening 22a in the distal end face 28.

[0051] After the capsule 150 is positioned outside the first lumen 22, the sheath 120 is manipulated to bring the capsule 150 against the target site T. According to one example, bringing the capsule 150 against the target site T may include bending the distal end of the catheter 20 and / or bending the hinged section of the sheath 120. In some examples, bringing the capsule 150 against the target site T includes dispensing fluid from the opening 24a or 26a to wet the capsule and activate an adhesive material on the outer surface of the capsule 150.

[0052] Once the capsule 150 adheres to the target site T, the sheath 120 moves away from the target site T by moving the sheath 120 proximally. Alternatively, the end effector 130 can grip the capsule 150 between a pair of jaws. The jaws of the end effector 130 can be actuated to increase pressure on the capsule 150, causing the outer shell of the capsule 150 to rupture and resulting in the dispersion of powder 160 at the target site T. The sheath 120 then retracts into the lumen 22, and the catheter 20 can be removed from the body cavity. According to another example, before the sheath 120 retracts into the lumen 22, the tether 152 can be released by pushing the reel 144 distally and opening the jaws of the end effector 130. In one example where the capsule 150 is soluble due to interaction with the liquid, flushing can be used to dissolve the capsule 150 and release the agent 160.

[0053] The distal end of a medical system 10, according to another example, is shown in... Figures 6A to 6C Similar components are indicated by similar reference numerals.

[0054] like Figure 6A As shown and similar to the sheath 120 described above, the sheath 220 extends through the lumen 22 of the conduit 20. The sheath 220 includes an end effector 230 at its distal end. Figure 6B As shown, the end effector 230 is umbrella-shaped in its deployment position, such that the most distal end of the end effector 230 has a larger diameter compared to the most proximal end. 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 patient's body heat can increase the temperature of the end effector 230, causing its shape to change from a contracted shape to an umbrella shape. Alternatively, the end effector 230 may include a collapseable structure; this collapseable structure forms a collapsed or folded orientation when disposed within the lumen 22, and forms a [missing information - likely a shape or structure] when exposed from the lumen 22. Figure 6B and Figure 6C The umbrella shape shown. Such collapsible structures can be formed from sheets of flexible material.

[0055] refer to Figure 6AThe end effector 230 collapses when disposed within the lumen 22. The end effector 230 is configured to push the capsule 250 (similar to capsule 150) away from the first opening 22a in the distal end face 28. Once exposed to moisture (such as the mucous membrane of the lumen L) or when fluid is sprayed from the openings 24a, 26a, the outer shell of the capsule 250 begins to degrade. Figure 6B The release of powder 260 from capsule 250 is shown after the outer shell of capsule 250 has dissolved.

[0056] refer to Figure 6B and Figure 6C The end effector 230 captures or coralizes 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 it completely dissolves, 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 powder 260 when it is not present in the capsule 230.

[0057] like Figure 6C As shown, the sheath 220 may include a hinged section 222 (similar to the hinged section described above) to allow a medical professional to manipulate the end effector 230 to access the target site T. The end effector 230 can also be manipulated in any of the ways 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 such that the inner distal surface of the end effector 230 faces the target site T to guide 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 can be maintained for a predetermined amount of time. In this way, the amount of powder 260 distributed at the target site T can be minimized while still maximizing the effect of the powder 260.

[0058] The operation of sheath 220 will now be described.

[0059] As discussed above, the capsule 250 can be inserted through port 44, and the distal end of the sheath 220 can subsequently be inserted through port 44. Like sheath 120, sheath 220 is pushed distally along lumen 22 using handle 140. End actuator 230 pushes the proximal end of capsule 250 to advance capsule 250 to the distal end of catheter 20, thereby causing end actuator 230 and capsule 250 to exit the first opening 22a.

[0060] As the capsule 250 exits the lumen 22, a medical professional may cause fluid to be ejected from the opening 24a or the opening 26a, causing the outer covering of the capsule 250 to begin to dissolve or completely dissolve. Alternatively, as discussed above, the capsule 250 may 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 a collapsed shape to an expanded umbrella shape, as if due to the physical properties of the material forming the end effector 230 or by actuation via an actuation cable or other actuation mechanism (not shown) to expand the end effector 230. Figure 6B As shown.

[0061] Subsequently, the sheath 220 is manipulated to capture the partially dissolved capsule 250 and / or powder 260. The sheath 220 is then manipulated such that the distal surface of the end effector 230 faces the target site T via, for example, the hinge segment 222, and the inner distal surface of the end effector 230 is pressed towards 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 positioned to contact the target site T (and the powder 260 coats the target site T) and press against the target site T. After a predetermined time period, the sheath 220 moves proximally, causing the end effector 230 to move into the lumen 22 and collapse into a low-profile shape.

[0062] The distal end of a medical system 10, according to another example, is shown in... Figure 7A and Figure 7B The end effector 330 has the same umbrella shape as the end effector 230 and may be formed from the same or similar material, and is deployed in the same manner as the end effector 230, as described above.

[0063] like Figure 7A As shown, the sheath 320 can be manipulated in any of the ways described above with respect to sheaths 120, 220 to access the target site T, including but not limited to bending the conduit 20 and / or bending the sheath 330. The sheath 320 includes a central lumen 324 extending from the handle 40 into the interior of the end effector 330 and terminating 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. Using any dispensing device known in the art, a capsule containing powder 360 (not shown), or powder 360 without a capsule, is delivered downwards from the central lumen 324 to the target site T. For example, a propellant fluid (such as CO2) can force the capsule or powder 360 downwards from a container along the central lumen 324 and out of the central opening 324a, which is attached, for example, via a handle 40 to the proximal end of the conduit 20. The outer diameter of the distal 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 be pressed 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, the delivery of powder 360 can be directly targeted to the target site T while minimizing the amount of powder released outside the target site T.

[0064] The operation of sheath 320 will now be described.

[0065] The sheath 320 is pushed distally along the lumen 22 using the handle 140. The end effector 330 exits the first opening 22a and extends in a manner similar to that of the end effector 230, for example, based on the physical properties of the material forming the end effector 330 or via an actuation cable (not shown) to extend the end effector 330.

[0066] After the end effector 330 is exposed from the first opening 22a, the end effector 330 is manipulated to cover the target portion T, such as... Figure 7B As shown. For example, the outer periphery of the distal end of the end effector 330 is positioned against the lumen wall LW of the lumen L and / or against the target portion T. In some instances, the outer periphery of the distal end of the end effector 330 completely surrounds the target portion T. In other embodiments, the target portion T may be large and / or may have a shape that is not completely surrounded by the outer periphery of the distal end of the end effector 330. Although the target portion T is shown as generally parallel to the distal end face 28, the target portion T may be at an angle relative to the target portion T, for example, generally perpendicular. Therefore, the distal end of the sheath 320 may be hinged in a manner similar to the hinge segment 222 disclosed herein, thereby entering the target portion T.

[0067] Once the end effector 330 is positioned against the target site T, powder 360 (e.g., fluidized powder), a capsule, or some other delivery mechanism containing a therapeutic agent is conveyed 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 (conveyed via, for example, fluidized powder, a capsule, etc.) contacts the target site T, the powder 360 adheres to the moisture of the mucous membrane and / or the moisture of the fluid, which can be ejected via the central lumen 324 and / or openings 24a, 26a. It should be understood that the powder 360 can be actuated by any actuation device (e.g., via...). Figure 9 The actuator 540 shown and discussed in more detail herein, or any other known delivery mechanism, conveys along the central lumen 324.

[0068] Another example of a sheath 420 used for deploying therapeutic materials is shown in Figure 8A and Figure 8B In the middle. For example Figure 8A As shown, the sheath 420 includes an end actuator 430 having a mold or press-like shape. The end actuator 430 may be cylindrical or disc-shaped. The end actuator 430 has a flat or substantially flat distal end with a larger circumference than the proximal end of the end actuator 430 and the sheath 420; and this proximal end connects to the distal end of the sheath 420. It should be understood that the shape is not limited to a mold or press-like shape, and the shape of the end actuator 430 may include shapes that facilitate the capture of capsules or powder, as described herein.

[0069] The capsule 450 is located distal to the end actuator 430 in the lumen 22. Figure 8AThe first opening 22a includes an annulus 22b to narrow the first opening 22a (relative to the cross-sectional size or diameter of the lumen 22). In some embodiments, the annulus 22b includes a tooth 24 or other sharp structure, such as a hook or barb, located on or extending radially inward from the inner circumferential surface of the annulus 22b. The outer diameter of the capsule 450 is larger than the diameter of the first opening 22a. As the sheath 430 moves distally relative to the conduit 20, the end effector 430 presses against the proximal side of the capsule 450, and the capsule 450 compresses the annulus 22b. The force of the capsule 450 compressing the annulus 22b (and in some embodiments, the tooth 24 or other sharp structure) causes the capsule 450 to rupture, thereby releasing powder 460. The opening 22a includes an inner diameter larger than the outer diameter of the end effector 430, such 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 is coated on the distal surface of the end effector 430, and as in other embodiments described herein, the sheath 420 is maneuverable toward the target site T, such as through the curved section 422. Powder 460 can adhere to the target site T when exposed to moisture in the lumen L or when exposed to fluid ejected from openings 24a, 26a. The end effector 430 is positioned toward 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 an appropriate amount of powder adheres to the treatment site T and is effective, for example, to stop bleeding. It should be understood that the annulus 22b and the teeth 24 can be used in any of the sheaths described herein to facilitate rupture of the capsule to expose and deliver the material or powder disposed within the capsule. Furthermore, in some embodiments, sharp structures are not present on the annulus 22b, and forcing the capsule 450 through the smaller diameter opening 22a will cause the capsule 450 to rupture to disperse the powder 460.

[0070] The operation of sheath 420 will now be described.

[0071] As with other sheaths described herein, the capsule 450 is inserted through port 44 before the distal end of sheath 420 is inserted into port 44. Sheath 420 is pushed distally along lumen 22 by handle 140, which causes end effector 430 to press against the proximal end of capsule 450, thereby causing end effector 430 and capsule to approach first opening 22a. As capsule 450 and end effector 430 approach first opening 22a, the distal end of capsule 450 contacts the surface of annulus 22b, which faces the interior of lumen 22 and / or teeth 24 or other sharp structures arranged on the inner surface or inner circumference of annulus 22b. The force of end effector 430 against the proximal end of capsule 450 and the force of annulus 22b and / or teeth 24 against the distal end of capsule 450 cause capsule 450 to rupture, thereby discharging powder 460.

[0072] The user continues to push the sleeve 420 distally, causing the powder 460 to contact the distal end of the end effector 430. The sleeve 420 is then manipulated in any manner described herein to face the target site T (e.g., via the hinge of the hinge segment 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, such as mucous fluid at the target site T and / or fluid sprayed via openings 24a, 26a. After a predetermined time period, the sleeve 420 moves proximally, causing the end effector 430 to return to its original position within the lumen 22.

[0073] An actuating device 540 for dispensing powder and / or capsules 550 is shown in 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 may be a pressurized fluid source used in hospitals, or it may be a device directly attached to the actuator 540, thus allowing the actuator 540 to be portable.

[0074] A fluid connector 544 connects to an internal chamber 548, which may include a capsule 550 or powder not contained within a capsule. The capsule 550 may be added individually, or a hopper or other container (not shown) may be attached to an actuation device 540 to supply the capsule or powder to the internal chamber 548. A conduit connector 549 connects a conduit 520 having a lumen 522 to the body 542. Once the triggering mechanism 546 is actuated, propellant fluid (e.g., CO2) is released from a pressurized fluid source 570, and the capsule 550 is delivered distally from the lumen 522 to an outlet (not shown) at the distal end of the conduit 520. According to one example, the amount of gas released may be approximately 16 liters or less, for example, equivalent to the amount of gas (such as 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 deliver the capsule 550 along the lumen 522, and it is also a safe amount of propellant fluid to supply to the body (blow-in).

[0075] The operation of the actuator 540 will now be described.

[0076] A capsule 550 is loaded into an internal chamber 548. A catheter 520 is introduced into the body through 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 actuates a trigger mechanism 546, causing propellant fluid to leave the fluid source 570 and enter the internal chamber 548. The propellant fluid causes the capsule 550 to travel distally from the internal chamber 548 through the catheter 520 to the target tissue. The propellant fluid is sufficient to deliver the capsule 550 along the lumen 520 while maintaining a safe amount of propellant fluid for introduction into the body (inhalation). Additional capsules 550 may be delivered to the same or different target sites until treatment is complete, at which point the catheter 520 is removed from the body.

[0077] It will be apparent to those skilled in the art that various modifications and variations can be made to the disclosed device without departing from the scope of this disclosure. For example, any material or fluid may be contained in the capsule and / or delivered in powder form for expulsion from the application device to a target location, including but not limited to materials with therapeutic effects. Additionally or alternatively, unless otherwise specified, the medical device described herein may be formed of any metal, alloy, plastic, or ceramic, or any combination thereof, suitable for medical applications. Other embodiments of this disclosure will be apparent to those skilled in the art in consideration of the specification and practice of the invention disclosed herein. It is contemplated that the specification and examples should be considered exemplary only, wherein the true scope and spirit of the invention are indicated by the following claims.

Claims

1. A medical system comprising: Handle; A sheath having a central longitudinal axis, wherein the sheath extends from the handle; and An end effector connected to the distal end of the sheath, wherein the end effector includes a collapsed form and an expanded form, wherein converting the end effector from the collapsed form to the expanded form causes the distal end of the end effector to expand radially outward to a first diameter, wherein in the expanded form, the first diameter is greater than a second diameter of the proximal end of the end effector. The end effector is configured to direct a large amount of material toward a target part of the body and cause the large amount of material to be released onto the target part.

2. The medical system according to claim 1, wherein, In the extended configuration, the farthest end of the end effector includes an inner distal surface configured to capture the mass of material.

3. The medical system according to claim 1, wherein, In the extended configuration, the end effector is pressed against the target portion, causing a partial or complete seal to be formed between the end effector and the target portion.

4. The medical system according to claim 1, wherein, The end effector includes a shape memory material, which allows the end effector to automatically transform from the collapsed shape to the expanded shape when exposed to body temperature.

5. The medical system according to claim 1, wherein, The end effector is formed from a flexible sheet.

6. The medical system according to claim 1, wherein, The sheath includes a hinged section, wherein actuating the hinged section of the sheath causes the end effector to deviate from the central longitudinal axis of the sheath.

7. The medical system according to claim 1, further comprising: A central lumen extends from the proximal end of the sheath to a distal opening at the distal end of the end effector, wherein the bulk material is delivered to the target site via the distal opening.

8. The medical system according to claim 7, wherein, The materials mentioned are powdered pharmaceuticals.

9. The medical system according to any one of claims 1-6, further comprising: A catheter, the catheter including a lumen extending to a distal lumen opening at a distal end of the catheter; and A capsule containing the aforementioned amount of material; The sheath, the end effector, and the capsule are located within the lumen; The end effector is configured to advance the capsule along the lumen through the distal lumen opening to the target site.

10. The medical system according to claim 9, wherein, The outer covering of the capsule includes an adhesive material configured to adhere to the target site when exposed to fluid.

11. The medical system according to claim 9, wherein, The outer covering of the capsule is configured to degrade upon exposure to fluid, thereby releasing the large amount of material.

12. The medical system according to claim 9, wherein, In the extended configuration, the farthest end of the end effector includes an inner distal surface configured to trap the mass of material, wherein the inner distal surface is configured to form a seal between the end effector and the target portion, wherein the trapped mass of material is disposed between the inner distal surface and the target portion.

13. The medical system according to claim 9, wherein, The end effector is configured to transition from the collapsed state to the expanded state when it leaves the distal lumen opening.

14. The medical system according to claim 9, wherein, The catheter is configured to bend when the distal end of the sheath is distal to the distal opening of the catheter lumen.

15. The medical system according to any one of claims 1-7, wherein, In the extended configuration, the end effector includes an umbrella shape.

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