Medical systems, devices, and related methods

Abstract

A medical system includes a medical device having a handle, a shaft, and an actuation member, and the medical system further includes a silo and a plunger. The handle includes an actuator movable relative to the handle, and the actuator is coupled to a distal end of the shaft via the actuation member. The cartridge contains a therapeutic agent, and the cartridge may be coupled to the distal end of the shaft. The plunger is movable relative to the silo. Movement of the actuator controls movement of the actuation member. Movement of the actuation member controls movement of the plunger or the silo to control delivery of the therapeutic agent from the silo.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority under 35 U.S.C. §119 to U.S. Provisional Application No. 63 / 332,023, filed on April 18, 2022, which is incorporated herein by reference in its entirety. Technical Field

[0002] The present invention relates generally to medical systems, devices and methods. In particular, the present invention relates to systems, devices and methods for endoscopically delivering one or more medicaments from a distal end of the device. Background Art

[0003] An agent (e.g., a therapeutic agent) can be delivered during a medical procedure, such as an endoscopic procedure. During an endoscopic procedure, a user inserts a sheath of an endoscope into a body cavity of a patient. The user controls (e.g., deflects and / or positions) the endoscope using a handle of the endoscope during the procedure. A tool is passed through a working channel of the endoscope via, for example, a port in the handle to deliver therapy at a treatment site near the distal end of the endoscope. The treatment site is located inside the patient and is therefore distal to the user.

[0004] During various surgeries, agents may be delivered through a device inserted into the working channel of an endoscope. On the other hand, agents may, for example, be delivered through the working channel itself via a port. In either case, when the agent is delivered, a portion of the agent may remain in a portion of the device or in the working channel, and therefore may not be delivered to the surgical site. However, a user may desire to deliver all or nearly all of the agent without leaving the remaining agent in the device. Additionally, delivering some agents through the length of the device or working channel may require force or pressure, which may prevent or inhibit the controlled delivery of the agent. In addition, many agents (e.g., therapeutic agents, such as cyanoacrylates or other adhesives, adhesives, etc.) may solidify (i.e., harden) in the device or in the working channel, which may form one or more blockages or obstructions. Blockages or obstructions may prevent or inhibit the delivery of agents through the device or working channel. Therefore, a system, device or method for delivering one or more agents through an endoscope is required. Summary of the invention

[0005] According to one example, a medical system may include a medical device having a handle, a shaft, and an actuation member, and the medical system may also include a silo and a plunger. The handle may include an actuator movable relative to the handle, and the actuator may be coupled to the distal end of the shaft via the actuation member. The silo may contain a therapeutic agent, and the silo may be coupled to the distal end of the shaft. The plunger may be movable relative to the silo. Movement of the actuator may control movement of the actuation member. Movement of the actuation member may control movement of the plunger or the silo to control delivery of the therapeutic agent from the silo.

[0006] The medical system may include one or more of the following features. The therapeutic agent may be an adhesive. The therapeutic agent may be a cyanoacrylate. The actuation member may include a sheath extending between the actuator and the plunger, such that distal movement of the actuator pushes the sheath and plunger distally to deliver the therapeutic agent from the silo.

[0007] The distal end of the shaft may include a fulcrum element fixed within the distal end of the shaft. The actuation member may include one or more wires extending distally from the actuator beyond the fulcrum element and extending proximally of the fulcrum element to a portion of the plunger, such that proximal movement of the actuator pushes the wires proximally and also pushes the plunger distally to deliver the therapeutic agent from the silo. The fulcrum element may include a ring fixed within the interior of the distal end of the shaft.

[0008] The plunger may be fixed to the shaft. The actuation member may include one or more wires extending distally from the actuator to a proximal portion of the silo such that proximal movement of the actuator pushes the one or more wires and the silo proximally to deliver the therapeutic agent from the silo. The plunger may be coupled to a distal end of the actuation member. The actuation member may include a threaded portion. The silo may include a groove portion configured to interface with the threaded portion of the actuation member such that rotation of the actuation member advances the plunger within the silo.

[0009] The silo may be removably coupled to the distal end of the shaft. The silo may include a proximal extension having a hook. The distal end of the shaft may include a slot, and positioning of the proximal extension within the slot may removably couple the silo to the distal end of the shaft. The slot may include a longitudinal slot and a radial slot. The radial slot may extend along a portion of the inner circumferential surface of the shaft in a direction perpendicular to the longitudinal axis of the shaft.

[0010] The handle may include a plurality of markings indicating the amount of therapeutic agent that has been delivered and / or remains in the silo. The silo may include a distal cover that is openable or removable to expose the distal opening of the silo and allow the therapeutic agent to be delivered from the distal opening. The distal cover may be a plug, and the plug may be coupled to the silo via a connecting element. The medical system may also include a lining element. The lining element may be coupled to the distal end of the silo, and the lining element may be hydrophobic and / or non-stick.

[0011] In another example, a medical device may include a silo and a plunger. The silo may contain a therapeutic agent. The silo may include a proximal extension having a hook, and the silo may be removably coupled to a distal end of a shaft via the proximal extension. The plunger may move relative to the silo. Movement of the plunger or the silo may control delivery of the therapeutic agent from the silo.

[0012] The medical device may include one or more of the following features. The therapeutic agent may be a cyanoacrylate. The silo may include a distal cover that is removable or openable to expose a distal opening of the silo and allow the therapeutic agent to be delivered from the distal opening.

[0013] In yet another example, a method may include delivering a distal end of a medical device to a treatment site, manipulating an actuator on a proximal handle to deliver a medicament from a silo to the treatment site, and removing the medical device and silo from the treatment site. The actuation member may actuate a non-fluid actuation member to control movement of a plunger or silo.

[0014] The method may include one or more of the following features. The method may also include attaching a silo to a distal end of the medical device. Additionally, the method may include opening or exposing a sealed distal end of the silo prior to operating an actuator on the proximal handle to deliver the medicament from the silo to the treatment site. Furthermore, the method may also include separating the silo from the distal end of the medical device and coupling another silo to the distal end of the medical device after removing the medical device and the silo from the treatment site.

[0015] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate examples of the present invention and, together with the description, serve to explain the principles of the present invention.

[0017] Figure 1 shows a perspective view of an exemplary medical system according to aspects of the present invention, the exemplary medical system comprising a medical device having a handle portion and an insertion portion, and a silo at a distal end of the insertion portion;

[0018] FIG. 2A to FIG. 2C are cross-sectional views of various embodiments of an insertion portion and a distal end of a silo according to aspects of the present invention;

[0019] Figure 3A is a cross-sectional view of another embodiment of an insertion portion and distal end of an exemplary silo according to additional aspects of the present invention, and Figure 3B and Figure 3C are side and cross-sectional views of a handle and an actuator coupled to the handle according to additional aspects of the present invention;

[0020] FIG. 4A to FIG. 4E is a side view of an insertion portion and a distal end of a silo with various exemplary distal covers at the distal end of the silo according to aspects of the present invention;

[0021] Figure 5Ais a partially exploded and cross-sectional view of a portion of another embodiment of an insertion portion and a distal end of an exemplary silo according to aspects of the present invention, and Figure 5B is a cross-sectional view of a silo according to aspects of the present invention;

[0022] Figure 6 is a flow chart of an exemplary method according to aspects of the invention. DETAILED DESCRIPTION

[0023] The terms "proximal" and "distal" are used herein to refer to the relative positions of the components of exemplary medical systems and exemplary medical devices. When used herein, "proximal" refers to a position that is relatively closer to the outside of the body or closer to a medical professional using a medical system or medical device. Conversely, "distal" refers to a position that is relatively farther away from a medical professional using a medical system or medical device or closer to the inside of the body. As used herein, the terms "include", "comprise", "have", "include" or other variations thereof are intended to cover non-exclusive content, so that a system, device or method including a list of elements includes not only those elements, but may include other elements that are not explicitly listed or are not inherent to the system, device or method. Unless otherwise specified, the term "exemplary" is used in the sense of "example" rather than "exemplary". As used herein, the terms "approximately", "substantially" and "about" represent a numerical range within + / -10% of the value.

[0024] Examples of the present invention include systems, devices and methods for promoting and / or improving the efficacy, efficiency, cost and / or safety of medical procedures. Embodiments of the present invention may relate to systems, devices and methods for performing various medical procedures and / or treating anatomical parts, for example, via body cavities such as, larynx, trachea, bronchi (main bronchi), lobes (secondary bronchi), segments (tertiary bronchi), bronchioles, terminal bronchioles or any other part of the respiratory system. Additionally, embodiments of the present invention may relate to systems, devices and methods for performing various medical procedures and / or treating parts of the large intestine (colon), small intestine, cecum, esophagus, stomach or any other part of the gastrointestinal tract or biliary tree. In addition, embodiments of the present invention may relate to systems, devices and methods for performing various medical procedures and / or treating parts of the kidneys, ureters, bladders, urethra or any other part of the urinary tract. In these aspects, the systems, devices and methods discussed herein may be used to treat any other suitable patient anatomical structure (collectively referred to herein as "treatment site").

[0025] Various embodiments described herein include single-use or disposable medical devices. Some aspects of the present invention can be used to perform endoscopy, arthroscopy, bronchoscopy, ureteroscopy, colonoscopy or other types of surgery. For example, the disclosed aspects can be used with duodenoscopes, endoscopes, gastroscopes, endoscopic ultrasonography ("EUS") mirrors, colonoscopes, ureteroscopes, bronchoscopes, laparoscopes, arthroscopes, cytoscopes, suction mirrors, sheaths, catheters, diagnostic or therapeutic tools or devices or any other suitable conveying devices or medical devices, for example, for treatment through a body cavity. Alternatively, various embodiments described herein can be delivered to a treatment site individually and / or used separately from another mirror or medical device. One or more of the elements discussed herein can be metal, plastic or any combination of shape memory metals (such as nitinol), shape memory polymers, polymers or biocompatible materials.

[0026] Reference will now be made in detail to examples of the invention as described above and as shown in the accompanying drawings. Whenever possible, the same reference numerals will be used throughout the drawings to refer to the same or similar parts. It should be noted that one or more aspects of the medical systems, devices, and methods discussed herein may be combined and / or used together with one or more aspects of other medical systems, devices, and methods discussed herein.

[0027] Figure 1 A medical system ("system") 100 is depicted. System 100 includes a medical device 102, which includes a handle portion ("handle") 104 and a shaft / insertion portion ("shaft") 106. Medical device 102 may be referred to herein as an endoscope, but it should be understood that medical device 102 may be an endoscope, duodenoscope, bronchoscope, ureteroscope, colonoscope, catheter, or other type of medical device. Additionally, system 100 includes a silo 108, which may be integrally formed with shaft 106 (i.e., at the distal end of shaft 106) or may be coupled (e.g., releasably coupled) to a distal portion of shaft 106. As discussed in detail below, silo 108 may contain one or more medicaments (e.g., a fluid adhesive or other therapeutic agent), and action on handle 104 may control delivery of the one or more medicaments, for example, via a non-fluid actuation member extending from handle 104 and through at least a portion of shaft 106.

[0028] In these aspects, the non-fluid actuating member can help allow controlled (e.g., gradual, measured and / or more precise) delivery or administration of one or more medicaments, for example, for treatment at one or more locations accessed via a body cavity. The non-fluid actuating member can help provide the user with the ability to control the start of the delivery of the fluid medicament and / or also stop (e.g., pause or end) the delivery of the fluid medicament. In some aspects, the non-fluid actuating member can allow the user to apply pressure or force to the fluid medicament without the user having to rely on the barrel strength, stiffness, etc. of the shaft 106. Additionally, the non-fluid actuating member can allow multiple silos (i.e., different silos) to be coupled to the distal end of the shaft 106. In addition, when the distal end of the shaft 106 is delivered to the treatment site, the non-fluid actuating member can bend, bend, deflect, etc. Although not shown, one or more parts of the system 100 (e.g., the shaft 106 and the silo 108) can be delivered to the treatment site by or along one or more parts of the insertion device (e.g., sheath, mirror, etc.). Alternatively, one or more portions of the system 100 (e.g., shaft 106 and silo 108) can be delivered to the treatment site in other ways. In addition, in some aspects, aspects discussed herein can allow for delivery of fluid medicaments while having a smaller footprint (i.e., smaller cross-sectional shape) for delivery to the treatment site, either via an insertion device (e.g., within a small channel or cavity in the insertion device or adjacent to the outer wall of the insertion device, i.e., in a "side saddle" arrangement) or separately.

[0029] As mentioned, the medical device 102 includes a handle 104 and a shaft 106. The handle 104 includes at least one actuator 110. As discussed below, the actuator 110 can be moved within the slot 112, for example, to help control the delivery of one or more medicaments from the silo 108. Additionally, a portion of the handle 104, for example, a portion of the handle 104 adjacent to the slot 112 can include, for example, one or more indicators, scales, or markings 114 along at least a portion of the slot 112. The markings 114 can help indicate to a user the position of the actuator 110 within the slot 112. In this regard, the handle 104 can include four markings 114, such as, for example, numbers, indicators, scales, or other markings that correspond to the amount (e.g., volume) of one or more medicaments remaining in the silo 108 and / or the amount (e.g., volume) of one or more medicaments delivered from the silo 108 based on the position of the actuator 110 within the slot 112. It should be noted that the handle 104 may include any number of indicia 114 to help correlate the amount of one or more medicaments in the silo 108 with the position of the actuator 110. In some examples, the indicia 114 (i.e., in the form of a scale) may form a ratchet or other component to help provide tactile or tactile feedback to a user controlling the actuator 110. For example, the actuator 110 may move between stops or detents in the slot 112, which may help correlate the amount of one or more medicaments delivered from the silo 108. Alternatively or additionally, the indicia 114 may provide visual feedback to the user controlling the actuator 110. Furthermore, although Figure 1 The actuator 110 is shown as a slider, but it should be understood that any suitable actuator may be used in addition to or in place of the actuator 110, such as one or more levers, buttons, knobs, joysticks, etc.

[0030] The shaft 106 can extend from the distal end of the handle 104. The shaft strain relief portion 116 can facilitate coupling the shaft 106 to the handle 104, for example, so that the shaft can deflect or articulate relative to the handle 104. In addition, although not shown, the handle 104 can include one or more of a deflection or articulation lever, a suction port, an instrument or irrigation port, and the like.

[0031] As discussed below and in FIG. 2A to FIG. 2C , Figure 3A , Figure 3C , Figure 5A and Figure 5B, one or more actuation members 118 (e.g., wires, cables (e.g., Bowden cables), strands, ropes, chains, wires, etc.) can extend from the handle 104 and through a portion of the shaft 106 (e.g., through the lumen of the shaft 106). For example, the actuation member 118 can be coupled to the actuator 110 via an actuator extension 120. For example, the actuator extension 120 can extend from the actuator 110 into the interior of the handle 104. The actuator extension 120 can move (e.g., move longitudinally) within the interior of the handle 104, for example, to control the movement of the actuation member 118 (i.e., distally or proximally) based on the movement of the actuator 110.

[0032] The medical device 102 may also include a cleaning portion or cleaning tool 122. The cleaning tool 122 may extend from a distal portion of the handle 104, for example, adjacent to and / or parallel to a proximal portion of the shaft 106. The cleaning tool 122 may include a cylindrical housing around a pin or other elongated member (not shown). As discussed below, the cleaning tool 122 may be used to assist in cleaning one or more portions (e.g., a distal opening) of the silo 108. For example, the cleaning tool 122 may include one or more of the aspects shown and discussed in U.S. Application No. 16 / 834,003, disclosed as U.S. Pre-Grant Publication No. 2020 / 0323610, which is incorporated herein by reference.

[0033] As discussed below, the silo 108 can be releasably coupled to the distal end of the shaft 106. A portion of the medical device 102 (i.e., the shaft 106) can then be delivered to the treatment site through or along the exterior of the insertion device, or can be delivered to the treatment site separately. Alternatively or additionally, various aspects of the medical device 102 (e.g., the actuator 110 and the actuating member 118) can be integrated into the insertion device handle and / or the insertion device shaft, and the insertion device shaft can be delivered to the treatment site. In these aspects, the endoscope can include one or more controls or actuators for controlling and / or actuating the silo 108.

[0034] FIG. 2A to FIG. 2C 1 is a cross-sectional view of a different embodiment of an actuation member located within a portion of the shaft 106 and interacting with the silos 208, 208'. Figure 1 ) can control the movement of one or more actuation members 218A, 218B, 218C, and thus control the relative movement of plungers 224A-224C and / or silos 208, 208' to facilitate delivery of one or more medicaments 226 from silos 208, 208', for example, from within the interior silo cavity 208A. FIG. 2A to FIG. 2CAs shown in, each plunger 224A-224C can include a proximal portion 228A-228C, respectively, which can abut against one or more actuating members. Each plunger 224A-224C can also include a distal portion 230A-230C, for example, it is connected to the corresponding proximal portion 228A-228C via a corresponding elongated portion 232A-232C. The distal portion 232A-232C may include a dome-shaped distal end. Alternatively, the distal portion 232A-232C may include a distal end of different shapes, for example, a flat distal end, a tapered distal end, a shape that tapers in a distal direction, etc. Each plunger 224A-224C can be coupled to the shaft 106 or a portion of the shaft 106. Alternatively, the plunger 224A-224C can be coupled to the silo 208, 208' or a portion of the silo 208, 208'.

[0035] In some examples, one or more portions of the shaft 106 may include an outer diameter that is sized or otherwise configured to fit within a working channel of an endoscope, for example, within a working channel of an endoscope having a diameter of about 2.8 mm to about 6.0 mm. Alternatively, as mentioned above, one or more portions of the shaft 106 may be delivered to the treatment site along or adjacent to the outer circumference of the delivery portion of the endoscope, for example, in a side saddle arrangement. In addition, in some examples, one or more portions of the silos 208, 208' may be sized, shaped (e.g., angles, curvatures, etc.) or otherwise configured to correspond to an interior portion of the shaft 106. Additionally, in some examples, one or more portions of the plungers 224A-224C may be sized, shaped (e.g., angles, curvatures, etc.) or otherwise configured to correspond to an interior portion of the silos 208, 208'. One or more of the components discussed herein may be formed of a non-stick lubricating material. One or more components may be made of, for example, polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (EPTFE), fluorinated ethylene propylene (FEP), acetyl plastics such as, for example, polyoxyethylene (POM), The invention is formed of one or more of Delron, polyethylene (PE), nylon or other suitable materials.

[0036] As mentioned above, the silo 208 can contain a supply of one or more medicaments 226. The medicament 226 can be a therapeutic agent, such as a cyanoacrylate or other adhesive, adhesive, etc. In other aspects, the medicament 226 can include one or more of an antimicrobial agent (e.g., one or more antibacterial agents), an anticoagulant, a coagulant, etc. Alternatively or additionally, the medicament 226 can include one or more of a chemotherapeutic agent, a contrast agent (e.g., a dilating agent dye for marking one or more anatomical structures), a dye for visualization enhancement (e.g., indigo carmine, an iodine-based solution such as, for example, Lugol's solution, a vital dye, etc.), or other medicaments to be delivered in a targeted and / or controlled manner. Additionally, in some aspects, the silo 208, 208' can contain multiple medicaments, for example, mixed, layered, or separated in different portions of the silo 208, etc. For example, in one or more aspects, the silo 208 can include a first medicament in a distal section of the silo 208 and a second medicament different from the first medicament in a proximal section of the silo 208 .

[0037] like FIG. 2A to FIG. 2C As shown, the silo 208 can include a proximal portion 234, which can be substantially cylindrical and can be positioned within or adjacent to the distal end of the shaft 106. The silo 208 can also include a distal portion 236, which can extend from the proximal portion 234 and can include a partial cone or a shape that tapers in size in a distal direction. The silo 208 can also include a distal opening 238. The distal opening 238 can be a circular opening, or can be a slit, a frangible section, etc., so that, for example, via movement of the distal portions 230A, 230B of the plungers 224A, 224B within the silo 208, the medicament can be delivered from the silo 208. As shown in FIG. Figure 2C As shown, the silo 208' can be positioned within the distal portion of the shaft 106, for example, the proximal portion 234' and / or the distal portion 236' can have a smaller transverse cross-sectional area (eg, 208') than the proximal portion 234 and the distal portion 236 of the silo 208. Figure 2A and Figure 2B ). The distal opening 238' of the silo 208' can have the same size as the distal opening 238 or a different size. Additionally, relative movement of the plunger 224C and the silo 208' can control the delivery of one or more medicaments 226 from the silo 208'.

[0038] Figure 2A1 is a first embodiment of the shaft 106 and the silo 208. As shown, the shaft 106 includes a sheath, for example, an outer sheath 240. The outer sheath 240 can surround the actuating member 218A, which can be an inner sheath. In these aspects, the actuating member 218A can move relative to the outer sheath 240 and within the outer sheath 240 (e.g., longitudinally). The inner sheath forming the actuating member 218A can abut against the outer sheath 240. The actuating member 218A can abut against the proximal portion 228A of the plunger 224A, for example, at a circular interface around the periphery of the proximal portion 228A. As shown, the actuating member 218A can have an inner cavity and can bend, bend, deflect, etc. when the shaft 106 is delivered to the treatment site. Alternatively, the actuating member 218A can be a solid member, for example, a solid cylindrical member. The proximal portion of the actuation member 218A may be coupled to the actuator 110 ( Figure 1 ), and thus can form an actuation member. Although not shown, a separate actuation member can be from the actuator 110 ( Figure 1 ) extends, and a separate actuation member can be coupled to the sheath-like actuation member 218A. The distal end of the actuation member 218A can abut against and / or be coupled to the proximal portion 228A of the plunger 224A.

[0039] In one or more aspects, the distal end of the actuation member 218A can be coupled to the proximal portion 228A of the plunger 224A, for example, via an adhesive, a snap fit, a press fit, or other coupling. Figure 2A As shown, for example, via distal movement of the actuator 110 ( Figure 1 ) can push the plunger 224A distally. The distal movement of the plunger 224A within a portion of the silo 208, 208' can push the medicament 226 distally out of the distal opening 238 of the silo 208, 208' to the treatment site, for example, in the direction 200. Additionally, the position of the plunger 224A within the silo 208, 208' corresponds to the position of the actuator 110 in the slot 112 ( Figure 1 ), so the user can determine the amount of agent 226 that has been delivered to the treatment site and / or the amount of agent 226 remaining in the silo 208, 208'. As mentioned and as Figure 1 As shown, handle 104 may include one or more indicators or markings, for example, along at least a portion of slot 112, for example, to indicate to a user the position of actuator 110 within slot 112, and thus the position of plunger 224A within silo 208, 208'.

[0040] Figure 2BAnother embodiment of the distal end of the shaft 106 and the silo 208 is shown. As shown, the shaft 106 includes an outer sheath 240. Additionally, the actuation member 218B (e.g., a wire, cable (e.g., a Bowden cable), a strand, a rope, a chain, a line, etc.) can be positioned within the outer sheath 240. The proximal portion of the actuation member 218B can be coupled to the actuator 110 ( Figure 1 ). A fixing element or fulcrum element 242, e.g., an at least partially circular element or ring, can be positioned within the distal end of the shaft 106, e.g., within the distal end of the outer sheath 240. Alternatively, the fulcrum element 242 can include one or more loops, hooks, flanges, etc., extending radially inwardly within the distal end of the outer sheath 240, e.g., to a portion of the movably received actuation member 218B. Additionally, the plunger 224B includes a proximal portion 228B, a distal portion 230B, and an elongated portion 232B. The fulcrum element 242 can be positioned between the proximal portion 228B and the distal portion 230B of the plunger 224B, e.g., adjacent a portion of the elongated portion 232B.

[0041] The actuation member 218B can extend distally from the actuator 110 within the outer sheath 240 and can extend distally through or around the fulcrum element 242. The actuation member 218B can then form a loop and extend back proximally and couple to the proximal portion 228B of the plunger 224B. The actuation member 218B can be moved relative to the fulcrum element 242, for example, via the actuator 110 ( Figure 1 ) is implemented by mobile. Figure 2B As shown, for example, proximal movement (i.e., in direction B) of the actuation member 218B achieved via proximal movement of the actuator 110 can push the plunger 224B distally. For example, since the actuation member 218B is looped around the fulcrum element 242 and then connected to the proximal portion 228B of the plunger 224B, the proximal movement of the actuator 110 pulls the proximal portion 228B distally to push the plunger 224B distally.

[0042] like Figure 2BAs shown, the actuating member 218B can include a bisection or slit 244. In this aspect, the actuating member 218B can include two portions extending distally from the slit 244. The actuating member 218B can be looped around two portions of the fulcrum element 242 and can be coupled to two portions of the proximal portion 228B of the plunger 224B. Thus, the actuating member 218B can apply force to the plunger 224B at two locations, for example, to uniformly push the plunger 224B distally. In addition, the proximal portion 228B of the plunger 224B can include one or more slots 246B, for example, to movably receive corresponding portions of the actuating member 218B extending distally to loop around the fulcrum element 242. It should be noted that in this embodiment, the initial position of the actuator 110 can be in the distal portion of the slot 112 ( Figure 1 As discussed above, distal movement of plunger 224B within a portion of silo 208 (caused by proximal movement of actuation member 218B) can push medication 226 within silo cavity 208 distally out of distal opening 238 of silo 208 to a treatment site, e.g., in direction 200.

[0043] FIG. 2c shows another embodiment of the distal end of the shaft 106 and the silo 208', which can be at least partially positioned within the distal portion of the shaft 106, as mentioned above. As shown, the shaft 106 includes an outer sheath 240. Additionally, one or more actuating members 218C (e.g., wires, cables (e.g., Bowden cables), strands, ropes, chains, lines, etc.) can be positioned within the outer sheath 240. For example, the one or more actuating members 218C can include two actuating members 218C. The proximal portion of the actuating member 218C can be coupled to the actuator 110 ( Figure 1). Additionally, a plunger 224C including a proximal portion 228C, a distal portion 230C, and an elongated portion 232C can be positioned within the distal portion of the shaft 106. The plunger 224C can be fixed relative to the distal portion of the shaft 106, for example, within the distal portion of the outer sheath 240. The plunger 224C can be fixed within the distal portion of the shaft 106 via an adhesive, a snap fit, a press fit, or other coupling. The silo 208' can be coupled to the actuation member 218C so that the silo 208' can move relative to the plunger 224C and the shaft 106. For example, the actuation member 218C can include two actuation members 218C coupled to respective sides of the proximal end 248 of the silo 208'. In addition, the proximal portion 228C of the plunger 224C can include one or more slots 246C, for example, to movably receive corresponding portions of the actuation member 218C so that the actuation member 218C can move relative to the proximal portion 228C. Additionally, the position of the two actuation members 218C applies force to the silo 208' at two locations, for example, to evenly push the silo 208' proximally.

[0044] The actuation member 218C can extend distally from the actuator 110 within the outer sheath 240 ( Figure 1 ), and can extend to the proximal end 248 of the silo 208'. The actuation member 218C can be coupled to the proximal end 248 via an adhesive, a snap fit, a press fit, or other coupling. Figure 2C As shown, for example, via the proximal movement of the actuator 110 ( Figure 1 ) The proximal movement of the actuating member 218C (ie, in the direction C) can push the silo 208' proximally. It should be noted that in this embodiment, the initial position of the actuator 110 can be in the distal portion of the slot 112 ( Figure 1 In this regard, proximal movement of the silo 208' relative to the plunger 224C can cause the distal portion 230C of the plunger 224C to apply a force to the medicament 226, thereby pushing the medicament 226 in the silo cavity 208A' distally out of the distal opening 238' of the silo 208' to the treatment site, for example, in the direction 200.

[0045] In these aspects, one or more non-fluid elements (e.g., actuation members 218A-218C) can actuate and help control the delivery of a fluid agent (e.g., agent 226) to a treatment site. Alternatively, although not shown, the silo 208, 20A and / or plungers 224A-224C can be actuated by a fluid flow. For example, the actuation member can be air or a fluid flow, for example, to actuate and / or move the plunger relative to the silo (or to actuate and / or move the silo relative to the plunger) to deliver one or more agents 226 from the silo.

[0046] FIG. 3A to FIG. 3CThe handle 304 ( Figure 3B and Figure 3C )、Axis 306( Figure 3A ) and Silo 308( Figure 3A ) Figure 3A As shown, the actuating member 318 includes a plunger portion 324. Additionally, the actuating member 318 can be rotated (eg, in direction D), for example, by actuating the actuator 310 on the handle 304 ( Figure 3B and Figure 3C ). At least a distal portion of the actuation member 318 includes a threaded portion 350. Additionally, the silo 308 can include a groove (or female thread) portion 308A, for example, to rotatably receive a portion of the threaded portion 324. Alternatively, although not shown, the distal portion of the shaft 306 can include a threaded portion configured to rotatably receive the threaded portion 350. In these aspects, rotating the actuation member 318 in a first direction (i.e., direction D) (via rotation of the actuator 310) can advance the actuation member 318 and the plunger portion 324 relative to the silo 308, for example, to push the medicament 326 distally out of the distal opening 338 of the silo 308, for example, in the direction 300. Conversely, rotating the actuation member 318 in a second direction (i.e., opposite to the direction D) can retract the actuation member 328 and the plunger portion 324 relative to the silo 308.

[0047] Additionally, as shown, the shaft 306 can include a sheath 340. The inner surface of the sheath 340 can include a recessed or reduced thickness portion 306A, e.g., at the distal end of the shaft 306, to accommodate a portion of the silo 308. For example, the proximal portion 334 of the silo 308 can be received within the distal portion of the shaft 306 in the recessed portion 306A. Furthermore, the inner surface of the shaft 306 can include an angled portion 306B at the distal-most end, e.g., to overlap a portion of the distal portion 336 of the silo 308. In these aspects, the silo 308 can be coupled to the shaft 306 (e.g., to the distal portion of the sheath 340) via an adhesive, a snap fit, a press fit, or other coupling.

[0048] The distal portion 336 of the silo 308 can include an internal taper, for example, including a reduced internal cross-section. Additionally, the interior portion of the silo 308 can include a distal cavity 352. In this regard, the internal taper of the distal portion 336 and / or the distal cavity 352 can form one or more stop surfaces to limit the distal movement of the plunger portion 324. Although not shown, FIG. 2A to FIG. 2C The distal portion of the shaft 106 of the embodiment may also include a recessed portion 306A and / or an angled portion 306B, for example, to help accommodate and / or retain a silo.

[0049] Figure 3B and Figure 3C Details of handle 304 are shown, including actuator 310 . Figure 3B is a side view of a portion of the handle 304, and Figure 3C 304 is a transverse cross-sectional view of a portion of the handle 304. As discussed above, the handle 304 can be coupled to the shaft 306 ( Figure 3A ). The actuator 310 can be movable relative to a portion of the handle 304. In these aspects, the actuator 310 can be coupled to the actuation member 318 ( Figure 3C ).

[0050] like Figure 3B and Figure 3C As shown, the actuator 310 may include a screw 354, for example, including a cylinder with a spiral thread. The proximal portion of the screw 354 may extend from the handle 304, and the distal portion of the screw 354 may be coupled to the proximal end of the actuating member 318. Alternatively, the screw 354 and the actuating member 318 may be a single integral component. In addition, on the other hand, the screw 354 and the actuating member 318 may be indirectly coupled via one or more intermediate elements. Additionally, in some aspects, the screw 354 may be coupled to the handle 304 via a coupling 356. The coupling 356 may be coupled to (for example, fixedly or temporarily mounted thereon) a portion of the handle 304, for example, coupled to an instrument port 358. The coupling 356 may include an internal thread, for example, corresponding to a thread on the screw 354. In this regard, the screw 354 and the coupling 356 may form an interface 360 ​​so that the screw 354 is advanced or retracted relative to the rotation of the coupling 356. Additionally or alternatively, although not shown, the actuator 310 may include a dial, wheel, or another user interface configured to transmit rotation to the actuation member 318 .

[0051] In these aspects, rotating the screw 354 relative to the coupler 356 can advance or retract the screw 354 relative to the handle 304 and thereby distally extend and / or proximally retract the actuation member 310 while also rotating the actuation member 310 (e.g., in direction D, as shown in FIG. Figure 3A354 and / or the coupling 356. In addition, the size and / or pitch of the threads on the screw 354 and / or the coupling 356 can correspond to the amount (e.g., volume) of the medicament 326 within the silo 308. For example, in this regard, rotating the screw 354 a certain amount (e.g., a quarter turn, a half turn, a full turn, etc.) to advance or retract the screw 354 can advance or retract the actuation member 310, and thus advance or retract the plunger portion 324 a certain distance. In one example, rotating the screw 354 a half turn can deliver a quarter of the volume of the medicament 326 within the silo 308. In addition, one or more portions of the handle 304, the screw 354, or the coupling 356 can include one or more indicators (not shown) such that the position of the screw 354 relative to the coupling 356 and / or the handle 304 can indicate the amount of medicament 326 within the silo 308 and / or the amount of medicament 326 delivered from the silo 308.

[0052] In some aspects, although not shown, the silo 308 can be removed from the sheath 340, with the plunger portion 324 (or a portion of the plunger portion 324) remaining within and / or coupled to the silo 308. For example, the actuation member 318 can selectively engage (i.e., couple and disconnect) with the plunger portion 324. In this aspect, the actuation member 318 can engage with the plunger portion 324 when the silo 308 is coupled to the distal portion of the sheath 340, and the actuation member 318 can be disconnected from the plunger portion 324 when the silo 308 is separated from the distal portion of the sheath 340. Alternatively or additionally, the plunger portion 324 can be a portion of the silo 308 (e.g., a non-removable portion of the silo 308). For example, the distal portion of the actuating member 318 can abut against the proximal portion of the plunger portion 324 such that distal movement of the actuating member 318 (rotationally or non-rotationally) can also advance the plunger portion 324 distally without the need to securely connect or attach the actuating member 318 and the plunger portion 324.

[0053] FIG. 4A to FIG. 4E4 is a side view of the distal end of the shaft 406 and the silos 408A-408E, which have various distal covers 462A-462E at their distal ends, respectively. The distal covers 462A-462E can help to form a seal at the distal end of the silos 408A-408E. The seal can help to form a closed end at the distal end of the silos 408A-408E, for example, during the delivery of the shaft 406 and the silos 408A-408E to the treatment site and / or before the delivery of the medicament. The closed end at the distal end of the silos 408A-408E can help to protect the medicament stored in the silos 408A-408E from accidental delivery and / or accidental contact with fluid or exposure at or near the treatment site. Then, the seal formed by the distal covers 462A-462E can be opened, for example, pushed, pierced or otherwise opened. For example, as discussed above, the relative movement of the plunger and the silo can push the medicament in the silo distally, and the medicament can abut and push the distal caps 462A-462E to open the seal. In addition, the distal caps 462A-462E can be coupled to the respective distal ends of the silos 408A-408E. Alternatively, the distal caps 462A-462E can be integrally formed with or integrally formed on the distal ends of the silos 408A-408E.

[0054] Figure 4A The shaft 406, the silo 408A, and the first distal cover 462A are shown in a first closed configuration (left) and a second open configuration (right). The first distal cover 462A can be a removable cap or a pressure valve. For example, the distal cover 462A can include an end cap 464 and an extension 466. The end cap 464 can cover at least a portion of the distal opening 438 of the silo 408A. The silo 408A can include a channel 468, for example, extending longitudinally in the distal portion of the silo 408A, for example, extending proximally from the distal opening 438. The extension 466 can extend into the channel 468 and can be movable (e.g., longitudinally movable) within the channel 468 to extend and / or retract the distal cover 462A, and can help maintain the connection between the end cap 464 and the silo 408A. For example, the distal cover 462A can be moved in direction E to at least partially expose the distal opening 438 so that one or more therapeutic agents in the silo 408A can be delivered, for example, in direction F. The first distal cover 462A, including the end cap 464 and / or the extension 466 can be urged in direction E by the force of the agent in the silo 408A, and / or can be urged in direction E by other user actuation, as described below with respect to Figure 5BAlthough not shown, the distal cap 462A can include a biasing element, such as a spring, connected to the proximal portion of the extension 466. In this regard, the distal cap 462A can help close the distal opening 438 when the plunger (not shown) and / or silo 408A is stationary and some or all of the medicament has been delivered from the silo 408A.

[0055] Figure 4B The shaft 406, silo 408B, and second distal cap 462B are shown. Figure 4B The second distal cover 462B is shown in a partially open configuration. Although not shown, the second distal cover 462B can be against the distal opening 438 in a closed configuration. The second distal cover 462B can be a movable flap. For example, the distal cover 462B may include an end flap 470 and an arm 472. The end flap 470 can cover at least a portion of the distal opening 438 of the silo 408B. The arm 472 can be coupled to the distal portion of the silo 408B. Additionally, the end flap 470 and / or the arm 472 can pivot, for example, in a direction G to at least partially expose the distal opening 438 so that one or more medicaments in the silo 408B can be delivered. The second distal cover 462B (including the end flap 470 and / or the arm 472) can be pushed in the direction G by the force of the medicaments within the silo 408B, and / or can be pushed in the direction G by other user actuation, as described below with respect to Figure 5B Although not shown, the distal cover 462A can include a biasing element, such as a spring that connects a portion of the end flap 470 to the arm 472. Alternatively or additionally, the end flap 470 can be formed of a shape memory material. In this regard, the distal cover 462B can help close the distal opening 438 when the plunger (not shown) and / or silo 408B are stationary and some or all of the medicament has been delivered from the silo 408B.

[0056] Figure 4C The shaft 406, silo 408C, and third distal cover 462C are shown. The third distal cover 462C can be a movable valve, for example, including two opposing valve arms 474A and 474B, which can cover and / or surround the distal opening 438 of the silo 408C. The valve arms 474A and 474B can, for example, expand and / or pivot in directions H and H', respectively, to at least partially expose the distal opening (not shown) so that one or more therapeutic agents in the silo 408C can be delivered. The third distal cover 462C (including the valve arms 474A and 474B) can be pushed in directions H and H' by the force of the agent within the silo 408C, and / or can be pushed in directions H and H' by other user actuation, as described below with respect to Figure 5BAlthough not shown, valve arms 474A and 474B may include a biasing element, such as a spring connecting portions of valve arms 474A and 474B. Alternatively or additionally, valve arms 474A and 474B may be formed of a shape memory material. In this regard, valve arms 474A and 474B may assist in closing a distal opening (not shown) when a plunger (not shown) and / or silo 408C is stationary and some or all of a medicament has been delivered from silo 408C.

[0057] Figure 4D The shaft 406, the silo 408D and the fourth distal cover 462D are shown. The fourth distal cover 462D can be a movable or pierceable element, such as a plug, a membrane, a film, a frangible portion or segment, etc. The fourth distal cover 462D can be pushed in the direction I by the force of the medicament in the silo 408D. Additionally or alternatively, as described with respect to Figure 5B As discussed in detail, the movable or puncturable element can be moved (e.g., pushed distally) or punctured, for example, via a portion or extension of the plunger and relative movement of the plunger and the cartridge 408D. In this regard, the movement or puncture can expose at least a portion of the distal opening 438. In one aspect, the distal cap 462D is a stopper, for example, including a proximal portion or cylindrical portion 476, for example, which is sized and configured to be received within a portion of the distal opening 438. In some aspects, the distal cap 462D can also include a widened portion 478, for example, at a distal portion of the distal cap 462D and wider than the cylindrical portion 476 and / or the distal opening 438. As described with respect to Figure 5B As discussed, the distal cap 462D can be pushed or advanced distally, for example, in direction I (i.e., by movement of medicaments within the silo 408D and / or by other user actuation) to at least partially expose the distal opening 438 so that one or more medicaments in the silo 408D can be delivered. Although not shown, the distal cap 462D can include a connecting element, such as a string connecting a portion of the distal cap 462D to the shaft 406 or silo 408D to help maintain the distal cap 462D proximate to the shaft 406 or silo 408D.

[0058] Figure 4E The shaft 406, the silo 408E, and the fifth distal cap 462E are shown. The fifth distal cap 462E can be a lining element 480. For example, the lining element 480 can extend from the distal opening 438. For example, the lining element 480 can be positioned in the distal cavity ( Figure 3A) within a portion of the silo 408E. The lining element 480 can also extend distally beyond the distal cavity and distal opening 438 of the silo 408E. The lining element 480 can be hydrophobic and / or non-stick, for example, to help allow the delivery of the medicament from the silo 408E, while also helping to prevent the medicament from hardening and / or helping to prevent the formation of a blockage. For example, the lining element 480 can be generally cylindrical and can be formed of fluorinated ethylene propylene ("FEP"), polytetrafluoroethylene ("PTFE"), or other suitable materials. In these aspects, when the plunger (not shown) and / or the silo 408E is stationary and some or all of the therapeutic agent has been delivered from the silo 408E, the distal cap 462E can help prevent the therapeutic agent in the silo 408E from being inadvertently dispersed or delivered through the distal opening 438 or otherwise, for example, by forming a narrow column of resistance. In addition, the distal cover 426E can help maintain the patency of the distal opening 438 or the silo 408E, for example, by providing a hydrophobic and / or non-stick lining for the distal opening 438 to help prevent the therapeutic agent (not shown) from adhering, solidifying, etc. to the distal portion of the silo 408E, for example, the inner wall at the distal opening 438.

[0059] According to an additional aspect of the present invention, Figure 5A is a partially exploded and cut-away view of a portion of the distal end of shaft 506 and silo 508, and Figure 5B is a cross-sectional view of the silo 508 and the actuating member 518. Figure 5A As shown, the actuation member 518 may include a cable, such as a Bowden cable. Alternatively, as discussed above, the actuation member 518 may include a wire, a strand, a rope, a chain, a line, etc. The actuation member 518 extends from a handle (not shown) and passes through at least a portion of the shaft 506, for example, inside a portion of the outer sheath 540. Figure 5B As shown, the actuation member 518 can be coupled to a proximal portion 528 (e.g., a proximally extending rod) of the plunger 524, for example, via a coupler 582. For example, the coupler 582 can be coupled to the proximal portion 528 via an adhesive, a snap fit, a press fit, a crimp, or other coupling, and the coupler 582 can be coupled to a distal portion of the actuation member 518 via an adhesive, a snap fit, a press fit, a crimp, or other coupling, etc. In this regard, distal movement of the actuation member 518 (e.g., via the actuator 110 ( Figure 1 ) can advance the plunger 524 distally. In addition, the distal movement of the plunger 524 can push the medicament 526 out of the silo 508, such as out of the silo cavity 508A and through the distal opening 538.

[0060] As mentioned above FIG. 3A to FIG. 3CAs discussed, in some aspects, although not shown, the silo 508 can be removed from the sheath 540 with the plunger portion 524 (or a portion of the plunger portion 524) remaining within and / or coupled to the silo 508. For example, the actuation member 518 can be selectively engaged (i.e., coupled and uncoupled) to the plunger portion 524. In this aspect, the actuation member 518 can be engaged with the plunger portion 524 when the silo 508 is coupled to the distal portion of the sheath 540, and the actuation member 518 can be disconnected from the plunger portion 524 when the silo 508 is uncoupled from the distal portion of the sheath 540. Alternatively or additionally, the plunger portion 524 can be a portion of the silo 508 (e.g., a non-removable portion of the silo 508). For example, a distal portion of the actuation member 518 can abut a proximal portion of the plunger portion 524 (e.g., the proximal portion 528) such that distal movement of the actuation member 518 can also distally advance the plunger portion 524 without securely coupling or attaching the actuation member 518 and the plunger portion 524. In one aspect, the proximal end of the proximal portion 528 can be received with an opening on the distal end of the actuation member 518 and / or an opening on the distal end of the coupler 582.

[0061] like Figure 5A and Figure 5B As shown in , the silo 508 can be releasably coupled and / or locked or otherwise secured to the distal end of the shaft 506. In this aspect, the silo 508 can include a coupling portion 584 that can extend proximally from the proximal portion 534 of the silo 508 and, for example, at least partially longitudinally overlap the coupler 582. Additionally, the silo 508 can include a proximal extension 586. For example, the proximal extension 586 can extend proximally from a portion of the coupling portion 584 of the silo 508. Additionally, the proximal extension 586 can include a radial extension or hook 588, for example, having a greater radial thickness (i.e., relative to the longitudinal axis of the silo 508) than the proximal extension 586. The distal portion of the shaft 506 can include a longitudinal slot 590, for example, extending longitudinally along the inner surface of the sheath 540. The longitudinal slot 590 can be connected to the radial slot 592, for example, extending radially along the inner circumferential surface of the sheath 540 at a position proximal to the distal end of the sheath 540. For example, the radial slot 592 can extend perpendicular to the longitudinal axis of the shaft 506, along about 180 degrees, about 90 degrees, about 75 degrees, about 60 degrees, about 45 degrees, etc. of the inner surface of the sheath 540. The longitudinal length of the longitudinal slot 590 can be approximately the same as the longitudinal length of the proximal extension 586. Additionally, the width of the radial slot 592 (e.g., measured parallel to the longitudinal axis of the shaft 506) can be similar to or greater than the longitudinal length of the hook 588.

[0062] In these aspects, the proximal extension 586 and hook 588 can be proximally inserted into the longitudinal slot 590 to facilitate coupling the silo 508 to the shaft 506. Additionally, the silo 508 can be rotated, for example, in direction J, to rotate the proximal extension 586 and hook 588 so that the hook 588 is positioned within the radial slot 592 to facilitate coupling the silo 508 to the shaft 506. In these aspects, the depth of the longitudinal slot 590 and the radial slot 592 can correspond to the depth (e.g., radial width) of the hook 588 relative to the proximal extension 586. Additionally, when the silo 508 is rotated so that the hook 588 is positioned within the radial slot 592, the remainder of the proximal extension 586 can be radially positioned within and / or against the inner surface of the sheath 540. Additionally, for example, after dispensing the medicaments 526 within the silo 508 (as discussed below), the silo 508 can be rotated, for example, in direction K, to rotate the proximal extension 586 and hook 588 so that the hook 588 is aligned with the longitudinal slot 590. The proximal extension 586 and hook 588 can then be pulled distally along the longitudinal slot 590 to help separate the silo 508 from the shaft 506. As described above, the silo 508 can be separated from the shaft 506, for example, after one or more medicaments 526 within the silo 508 have been delivered, and so that another silo can be coupled to the shaft 506 (e.g., to replace a used silo 508 with a new silo 508).

[0063] In addition, if Figure 5A and Figure 5B As shown, a plug 562 can be coupled to the distal end of the silo 508, for example, to at least partially block the distal opening 538. Figure 4D As discussed, the plug 562 can include a cylindrical portion 576, for example, configured to extend within the distal opening 538. Additionally, the plug 562 can include a widened portion 578 at the distal end.

[0064] like Figure 5B As shown, the plunger 524 can include or be coupled to a rod 594, e.g., extending distally of the distal portion 530 of the plunger 524. In this regard, distal movement of the plunger 524 can advance the rod 594, and the rod 594 can contact the stopper 562 (e.g., the proximal end of the cylindrical portion 576) and help push the stopper 562 out of the distal opening 538 so that the medicament 526 can be delivered from the silo 508. In this regard, as described with respect to Figure 1 and Figure 2A As discussed, the actuator can be advanced distally within a slot on the handle to distally advance the actuation member 518 and plunger 524. Alternatively, as described with respect to FIG. 3A to FIG. 3CAs discussed, the actuator can be rotated relative to a portion of the handle to rotate the actuation member 518. For example, a portion of the shaft 506, the sheath 540, or the coupling 582 can provide a threaded interaction so that rotation advances the actuation member 518 and also advances the plunger 524 and the rod 594. In another aspect, as described with respect to Figure 2B and Figure 2C As discussed, the actuator can be retracted proximally, causing the actuation member to retract proximally to pull the plunger 524 distally (e.g., by looping around the fulcrum element, as described with respect to Figure 2B ) or pull the silo 508 proximally (e.g., where the actuation member is coupled to the silo, as discussed with respect to Figure 2C In any of these aspects, the rod 594 can extend about 50%, about 60%, about 70%, about 80%, about 90%, or about 95% of the length of the silo cavity 508A containing the medicament 526. Additionally, the cross-sectional dimension (e.g., diameter) of the rod 594 can be smaller than the dimension of the distal opening 538, for example, so that the medicament 526 can be delivered to the treatment site around the rod 594. Furthermore, it should be noted that any of the embodiments discussed herein (i.e., Figure 1 , FIG. 2A to FIG. 2C , FIG. 3A to FIG. 3C and FIG. 4A to FIG. 4E ) may include a rod similar to rod 594 extending from, for example, a distal portion of a corresponding plunger to assist in opening, revealing, or otherwise clearing a distal opening of the silo.

[0065] In one or more aspects, the plug 562 can be coupled to a portion of the silo 508 via a connecting element 596, e.g., a wire, a strand, a string, a lug, etc. Although not shown, alternatively or additionally, the plug 562 can be coupled to a portion of the shaft 506 via the connecting element 596 or via another connecting element. In these aspects, when the plug 562 is pushed out of the distal opening 538 by the rod 594, the connecting element 596 can help retain the plug 562 so that the plug 562 remains near the silo 508, the distal portion of the shaft 506, or otherwise remains at or near the treatment site. In these aspects, when the shaft 506 and silo 508 are removed from the treatment site, the plug 562 can be removed. Alternatively, another treatment device (e.g., a grabber, a basket, etc.) can be used to retrieve and collect the plug 562, for example, by capturing the plug 562 and / or separating the plug 562 from the connecting element 596. Alternatively or additionally, plug 562 may be formed from a biocompatible material that can safely dissolve or otherwise decompose within the patient's body.

[0066] Figure 6A method 600 is shown that can be performed with any of the medical systems discussed herein or portions of the systems. An optional first step 602 includes attaching a silo 108, 208, 208', 308, 408A-E, 508 to a distal end of a medical device 102, such as a distal end of a shaft 106, 306, 406, 506. FIG. 2A to FIG. 2C As discussed, the silo may abut the distal end of the shaft, or may be at least partially received within the distal end of the shaft. Figure 3A As discussed, the distal end of the shaft may include one or more shapes, contours, etc. to assist in retaining the silo. Figure 5A and Figure 5B As discussed, the silo 508 can be releasably coupled to the distal end of the shaft 506 , such as, for example, to the distal end of the sheath 540 .

[0067] Next, step 604 includes delivering the distal end of the medical device to the treatment site. As discussed above, the distal end of the medical device can be delivered to the treatment site via an insertion device, for example, through a lumen of the insertion device or adjacent to or along an outer wall of the insertion device (i.e., in a "side saddle" arrangement). Alternatively, the distal end of the medical device can be delivered directly to the treatment site, for example, via a guidewire, steering, imaging, etc.

[0068] Next, optional step 606 includes opening the sealed distal end of the silo. The sealed distal end of the silo can help prevent contamination during delivery to the treatment site and / or can help prevent the one or more agents in the silo from solidifying. FIG. 4A to FIG. 4E and FIG. 5A to FIG. 5B As discussed, one of the distal covers can be coupled to the distal end of the silo. The distal cover can be reclosable, for example, as described with respect to FIG. 4A to FIG. 4C and Figure 4E Alternatively, the distal cover may be removed via action on a proximal actuator, for example, as discussed with respect to Figure 4D , Figure 5A and Figure 5B discussed.

[0069] Step 608 includes operating an actuator on the proximal handle to deliver the medication from the silo to the treatment site. Figure 1 , Figure 2A , Figure 5A and Figure 5B As discussed, manipulation of the actuator may include advancing the actuator distally to deliver the medicament. Figure 2B and Figure 2C As discussed, manipulation of the actuator may include retracting the actuator proximally to deliver the medicament. FIG. 3A to FIG. 3CAs discussed, manipulation of the actuator may include rotating the actuator to deliver the medicament. In any of these aspects, the medicament may be incrementally and / or controllably delivered from the silo out of the distal end of the silo. Additionally, the actuation may be non-fluid, for example, such that proximal manipulation of the actuator delivers a non-fluid force on a plunger or portion of the silo to deliver the medicament out of the silo. Additionally, as mentioned, the medicament may include one or more medicaments. Additionally, in some aspects, such as with respect to Figure 1 As discussed, the handle 104 can include a plurality of indicators or markings 114, such as numbers or other indicators or markings within the slot 112 adjacent to the actuator 110. The indicators or markings 114 can assist a user in correlating the position of the actuator 110 within the slot 112 with the amount of one or more medicaments remaining in the silo 108 and / or the amount of one or more medicaments delivered to the treatment site with the position of the actuator 110.

[0070] Then, step 610 includes removing the medical device and silo from the treatment site. Step 610 may include removing the medical device and silo from the treatment site by or along the insertion device. Alternatively, step 610 may include removing the medical device and silo separately from the insertion device, for example, if the medical device and silo are not delivered by the insertion device. Figure 5A and Figure 5B As mentioned, this step may also include removing the plug 562 , which may be connected to the distal end of the silo 508 or shaft 506 via a connecting element 596 , for example.

[0071] Additionally, optional step 612 includes separating the silo from the distal end of the medical device and coupling another silo to the distal end of the medical device. Figure 5A and Figure 5B As discussed, silo 508 can be releasably coupled to the distal end of shaft 506, e.g., to the distal end of sheath 540 via the interaction of proximal extension 586 and hook 588 with longitudinal slot 590 and radial slot 592. In this regard, if the contents of the first silo (i.e., medicament 526) have been delivered to the treatment site, the first silo can be separated from the distal end of the shaft. Additionally, a second silo with additional or different medicament can then be coupled to the distal end of the shaft to provide additional treatment to the treatment site. Finally, if additional treatment is required at the treatment site (i.e., delivery of additional medicament), method 600 can return to step 604.

[0072] The systems, devices and methods discussed herein can allow one or more medicaments (e.g., liquid or fluid medicaments) to be delivered to a treatment site. Additionally, in some aspects, the delivery of one or more medicaments is controlled via non-fluid actuation. For example, the movement of one or more actuating members (e.g., realized via the movement of an actuator on a handle) can control the delivery of a fluid medicament from a silo. In these aspects, the possibility of a fluid medicament solidifying, solidifying before being delivered to a treatment site, causing one or more blockages in a medical device or silo, etc. is reduced. Additionally, the movement of the actuating member can control the movement of the plunger, which can help to deliver one or more medicaments in a controlled manner so that a desired amount of one or more medicaments can be delivered to a treatment site. In addition, the handle can include one or more indications or markings, which can help the user to associate the position of the actuator with the amount of one or more medicaments left in the silo and / or delivered to the treatment site. In some aspects, the silo can also be removably connected to the distal end of the shaft, for example, so that a plurality of silos can be connected to the distal end of the shaft, so as to replace the user silo, deliver different medicaments to the treatment site, etc. Various aspects discussed herein may help facilitate and / or improve the efficacy, efficiency, cost, and / or safety of medical procedures.

[0073] Other embodiments of the present invention will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only, with the true scope and spirit of the present invention being indicated by the following claims.

[0074] It should be understood that one or more aspects of any of the medical systems, devices, and methods described herein can be used in conjunction with any other medical system, device, or method known in the art, such as a medical imaging system, catheter, elongated instrument, or other scope, such as a colonoscope, bronchoscope, ureteroscope, duodenoscope, or the like, or other types of imagers. It should also be understood that one or more aspects of any of the medical systems, devices, and methods described herein can be used to treat tissue in any part of the human body. For example, any of the medical systems, devices, and methods described herein can be used in medical procedures, such as for endoscopic pancreaticobiliary angiography, colonoscopy, cancer screening, mucous lesion inspection, and / or other procedures requiring removal and / or detection of this type of tissue.

[0075] Although the principles of the present invention are described herein with reference to illustrative examples for specific applications, it should be understood that the present invention is not limited thereto. Personnel with ordinary skills in the art and access to the teachings provided herein will recognize that additional modifications, applications, and replacements of equivalents all fall within the scope of the examples described herein. Therefore, the present invention should not be considered to be limited by the foregoing description.

Claims

1. A medical system, comprising: a medical device having a handle, a shaft, and an actuation member, wherein the handle includes an actuator movable relative to the handle, and wherein the actuator is coupled to a distal end of the shaft via the actuation member; a silo containing a therapeutic agent, wherein the silo is coupleable to the distal end of the shaft; and a plunger movable relative to the silo, Wherein movement of the actuator controls movement of the actuation member, and wherein movement of the actuation member controls movement of the plunger or the silo to control delivery of the therapeutic agent from the silo.

2. The medical system according to claim 1, wherein: The therapeutic agent is a binder.

3. The medical system according to claim 2, wherein: The therapeutic agent is a cyanoacrylate.

4. A medical system according to any preceding claim, wherein: The actuation member includes a sheath extending between the actuator and the plunger, such that distal movement of the actuator pushes the sheath and plunger distally to deliver the therapeutic agent from the silo.

5. A medical system according to any preceding claim, wherein: The distal end of the shaft includes a fulcrum element fixed within the distal end of the shaft, wherein the actuation member includes one or more wires extending distally from the actuator beyond the fulcrum element and extending proximally from the fulcrum element to a portion of the plunger, such that proximal movement of the actuator pushes the wires proximally and also pushes the plunger distally to deliver the therapeutic agent from the silo.

6. The medical system according to claim 5, wherein: The fulcrum element includes a ring secured within the interior of the distal end of the shaft.

7. A medical system according to any preceding claim, wherein: The plunger is fixed to the shaft, and wherein the actuation member includes one or more wires extending distally from the actuator to a proximal portion of the silo, such that proximal movement of the actuator pushes the one or more wires and the silo proximally to deliver the therapeutic agent from the silo.

8. A medical system according to any preceding claim, wherein: The plunger is coupled to a distal end of the actuation member, wherein the actuation member includes a threaded portion, wherein the silo includes a recessed portion configured to interface with the threaded portion of the actuation member such that rotation of the actuation member advances the plunger within the silo.

9. A medical system according to any preceding claim, wherein: The silo is removably coupled to the distal end of the shaft.

10. The medical system according to claim 9, wherein: The silo includes a proximal extension having a hook, wherein the distal end of the shaft includes a slot, and wherein positioning of the proximal extension within the slot removably couples the silo to the distal end of the shaft.

11. The medical system according to claim 10, wherein: The slots include a longitudinal slot and a radial slot, wherein the radial slot extends along a portion of an inner circumferential surface of the shaft in a direction perpendicular to a longitudinal axis of the shaft.

12. A medical system according to any preceding claim, wherein: The handle includes a plurality of markings indicating an amount of the therapeutic agent that has been delivered and / or remains within the silo.

13. A medical system according to any preceding claim, wherein: The silo includes a distal cover that is openable or removable to expose a distal opening of the silo and allow the therapeutic agent to be delivered from the distal opening.

14. The medical system according to claim 13, wherein: The distal cap is a bung, and wherein the bung is coupled to the silo via a connecting element.

15. A medical system according to any preceding claim, further comprising a lining element, wherein The lining element is coupled to a distal end of the silo, and wherein the lining element is hydrophobic and / or non-stick.

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