Agent delivery device

Abstract

To provide a catheter device for delivering one or more agents with an endoscope.SOLUTION: A medical device may comprise a handle and a flexible sheath extending from the handle. The sheath may include a first chamber configured to house a first agent and a second chamber configured to house a second agent. Each of the first chamber and the second chamber may be disposed in a distal portion of the sheath. The sheath may also include a first piston housed within the first chamber, a second piston housed within the second chamber, and at least one actuation element configured to transmit a force from the handle to each of the first piston and the second piston. When the handle is in a first configuration, the first agent may be maintained within the first chamber and the second agent is maintained within the second chamber. When the handle is in a second configuration, the first agent may be released from the first chamber to mix with the second agent.SELECTED DRAWING: Figure 4A

Description

[Technical Field]

[0001] The present invention relates to drug delivery devices, and more particularly to catheter devices for endoscopic delivery of one or more drugs. [Background technology]

[0002] The agent may be delivered during a medical procedure, such as endoscopic surgery. During endoscopic surgery, a user inserts an endoscope sheath into a body lumen of a patient. The user utilizes the endoscope's handle to control the endoscope during the procedure. An instrument is passed through the endoscope's working channel, such as through a port in the handle, to deliver the therapeutic agent to a surgical site near the distal end of the endoscope, the surgical site being remote from the operator.

[0003] During endoscopic surgery, medications may be delivered by a device inserted into the working channel of an endoscope. When a medication is introduced into the device at its proximal end (port), some of the medication may be retained within the internal portion of the device within the working channel and not delivered to the surgical site. However, a user may wish to deliver all or nearly all of the medication without leaving any remaining medication within the device. Therefore, a need exists for a medication delivery device. Summary of the Invention

[0004] Examples of the present invention relate particularly to drug delivery devices. Each of the examples described herein may include one or more of the elements described with respect to the described example. In one example, the medical device includes a handle and a flexible sheath extending from the handle. The sheath includes a first chamber configured to contain a first agent and a second chamber configured to contain a second agent. The first chamber and the second chamber are each disposed in a distal portion of the sheath. The sheath also includes a first piston housed in the first chamber, a second piston housed in the second chamber, and at least one drive element configured to transmit force from the handle to each of the first piston and the second piston. When the handle is in the first configuration, the first agent is held in the first chamber and the second agent is held in the second chamber. When the handle is in the second configuration, the first agent is released from the first chamber and mixed with the second agent.

[0005] Any of the exemplary medical devices disclosed herein may include any of the following elements: The second chamber is defined by a tube disposed within the first chamber. The wall of the tube may include a plurality of holes. The distal-most end of the tube may be proximal to the opening at the distal-most end of the sheath. The central longitudinal axis of the tube may be approximately coaxial with the central longitudinal axis of the first chamber. The first piston may have an outer periphery and an inner periphery. The second piston may have an outer periphery with a shape complementary to the shape of the inner periphery of the first piston. The first drive element may be a tube defining a lumen. The second drive element may be a wire within the lumen. The at least one drive element may include a first flexible drive element having a proximal end operably coupled to the handle and a distal end operably coupled to the second piston, and a second flexible drive element having a proximal end operably coupled to the handle and a distal end operably coupled to the second piston. The first drive element may include a wire. The second drive element may include a wire or a tube. The wire of the first drive element is disposed within the lumen of the tube of the second drive element. The sheath may include at least one barrier that prevents release of the first agent from the first chamber. The at least one drive element may include a pneumatic fluid. The first chamber may be pre-filled with the first agent. The second chamber may be pre-filled with the second agent. A distal portion of the sheath may be removably attached to the remainder of the sheath.

[0006] In another example, a medical device may include a handle including an actuator and a sheath extending from the handle. A distal portion of the sheath may include a first chamber configured to contain a first agent and a tube disposed within the first chamber. The tube may have an internal lumen defining a second chamber. A wall of the tube may include a plurality of holes. The distal portion of the sheath may operably include at least one drive element for transmitting force from the actuator to each of a first piston housed in the first chamber and a second piston housed in the second chamber. The plurality of holes may be configured to isolate the first agent from the second agent when the at least one drive element is not subjected to force, and to release the second agent from the second chamber through the plurality of holes to mix with the first agent when the at least one drive element is subjected to force.

[0007] Any of the exemplary medical devices disclosed herein may include any of the following elements: The drive element may include at least one of a wire, a tube, or a fluid. The at least one drive element may be a first drive element. The medical device may further include a second drive element. The second drive element may include at least one of a wire or a tube.

[0008] In another example, the medical device may include a handle including an actuator and a sheath extending from the handle. The sheath may include a first chamber configured to contain a first agent and a second chamber configured to contain a second agent. The first and second chambers may each be disposed in a distal portion of the sheath. The sheath may also include a first piston housed in the first chamber, a second piston housed in the second chamber, and a tube configured to transmit force from the actuator to at least one of the first piston and the second piston.

[0009] Any of the exemplary medical devices disclosed herein may include any of the following elements: The second chamber may be defined by a tube disposed within the first chamber, and the radial wall of the tube may include a plurality of holes.

[0010] 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. As used herein, the terms "comprises," "comprising," or any other variations thereof are intended to include a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements, but may include other elements not expressly listed in or inherent to such process, method, article, or apparatus. The term "exemplary" is used in the sense of "example" rather than "ideal." The term "distal" refers to a direction away from the operator, and the term "proximal" refers to a direction closer to the operator. The term "approximately" or similar terms (e.g., "substantially") include values ​​of + / - 10% of the stated value.

[0011] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate examples of the present disclosure and, together with the description, serve to explain the principles of the disclosure. [Brief explanation of the drawings]

[0012] [Figure 1] 1 illustrates an exemplary drug delivery device. [Figure 2A] 2 illustrates an exemplary distal end of the drug delivery device of FIG. 1. [Figure 2B] 2 illustrates an exemplary distal end of the drug delivery device of FIG. 1. [Figure 3A] 2 illustrates an exemplary distal end of the drug delivery device of FIG. 1. [Figure 3B] 2 illustrates an exemplary distal end of the drug delivery device of FIG. 1. [Figure 4A] 2 illustrates an exemplary distal end of the drug delivery device of FIG. 1. [Figure 4B] 2 illustrates an exemplary distal end of the drug delivery device of FIG. 1. [Figure 5A] 1 illustrates another exemplary drug delivery device. [Figure 5B] 1 illustrates another exemplary drug delivery device. [Figure 6A] 10A and 10B illustrate other exemplary drug delivery devices. [Figure 6B] 10A and 10B illustrate other exemplary drug delivery devices. [Figure 6C] 10A and 10B illustrate other exemplary drug delivery devices. [Figure 6D] 10A and 10B illustrate other exemplary drug delivery devices. [Figure 6E] 10A and 10B illustrate other exemplary drug delivery devices. [Figure 6F] 10A and 10B illustrate other exemplary drug delivery devices. [Figure 6G] 10A and 10B illustrate other exemplary drug delivery devices. [Figure 6H] 10A and 10B illustrate other exemplary drug delivery devices. [Figure 6I] 10A and 10B illustrate other exemplary drug delivery devices. [Figure 6J] 10A and 10B illustrate other exemplary drug delivery devices. DETAILED DESCRIPTION OF THE INVENTION

[0013] The drug delivery device may be configured to house the drug at its distal end after placement at the treatment site to minimize the amount of drug remaining in the delivery device and avoid drug waste. The delivery device may be configured to house a single-component drug or a multi-component drug. In the case of a multi-component drug, the delivery device may be configured to allow mixing of the components prior to delivery from the device. Various mechanisms may be utilized to drive the delivery device to deliver the drug. These mechanisms may include air pressure, wires, tubes, or any suitable combination thereof.

[0014] FIG. 1 illustrates an exemplary delivery device 10. The delivery device 10 includes a handle 12 (operation portion) and a sheath 14 (insertion portion). The sheath 14 may include a catheter 15 or another suitable element. The sheath 14, or at least an element of the sheath 14 (such as the catheter 15), is flexible so that the sheath 14 can be advanced through a working channel of an endoscope within a serpentine body lumen. The cross-sectional diameter of the sheath 14 is configured so that the sheath 14 can be advanced through the working channel of an endoscope. A lumen 20 (see FIGS. 2A-4B) may extend from a proximal portion of the catheter 15 to a distal end of the catheter 15.

[0015] The sheath 14 also includes a distal portion 16. The distal portion 16 may be a separate element from the catheter 15 or may be of unitary construction with the catheter 15. The distal portion 16 may be rigid or flexible and may be sized to allow the distal portion 16 to be advanced through a working channel of an endoscope. The distal portion 16 may be fixedly or removably attached to the distal end of the catheter 15. The distal portion 16 may be configured to house a drug, such as in a compartment. The distal portion 16 may have a variety of configurations, as described herein with respect to Figures 2A-4B.

[0016] 2A-4B show cross-sectional views of exemplary distal portions 16, 116, 216 of delivery device 10. Elements of distal portions 16, 116, 216 may be combined with one another in any suitable combination. Wherever possible, like reference numbers are used to indicate corresponding structure.

[0017] 2A and 2B show examples of distal section 16. Distal section 16 includes chamber 30 for containing medication 32. Chamber 30 may be formed by surfaces defining lumen 20. For example, the inner surface of catheter 15 may define lumen 20 and chamber 30 in configurations in which distal section 16 is integral with catheter 15. Alternatively, chamber 30 may be defined by other surfaces. While chamber 30 is shown occupying the entire cross-sectional width of the lumen defined by distal section 16, chamber 30 may be a portion of distal section 16. For example, a tube or similar structure may be disposed within distal section 16, and chamber 30 may be located within the tube or other structure. Opening 18 may be in communication with chamber 30 so that medication 32 may pass through opening 18 as needed by the user, as described below.

[0018] The piston 52 may be slidably received within at least one of the chamber 30 and the lumen 20. The piston 52 is sealed against a seal to prevent proximal movement of the medicament 32 past the piston 52. The piston 52 may be configured to move proximally and / or distally within the chamber 30. An actuator 50 (FIG. 1) on the handle 12 may be used to move the piston 52. The actuator 50 may include a plunger, as shown in FIG. 1, or alternative structures as described below. For example, the actuator 50 may include a knob, a button, a switch, a lever, a slider, or another structure. Exemplary mechanisms for operably connecting the actuator 50 to the piston 52 are described in further detail below in FIGS. 5A-6J.

[0019] The medicament 32 can be any suitable type of medicament in any suitable form. The medicament 32 can be a gel, liquid, powder, or the like. For example, the medicament 32 can include a hemostatic agent, a clotting agent, a drug, or other medication. The medicament 32 can be pre-loaded into the distal portion 16. If the medicament 32 is pre-loaded, the delivery device 10 or a portion of the delivery device 10 can be single-use. Alternatively, a user can load the medicament 32 into the distal portion 16. For example, the medicament 32 can be loaded into the distal portion 16 by pulling the actuator 50 to move the piston 52 proximally. The distal portion 16 can include markings or other indicators of how much medicament 32 has been loaded into or dispensed from the distal portion 16. The distal portion 16 may be removably attached (e.g., by threads, snap fit, or other mechanism) to the catheter 15 such that the distal portion 16, with the compartments 30 pre-filled with the agent 32, is attached to the reusable (or disposable) catheter 15 prior to use. After the agent 32 is dispensed through the opening 18, as described below, the distal portion 16 may be replaced with a new pre-filled distal portion 16.

[0020] The medicament 32 may be retained within the chamber 30 by various mechanisms. For example, the force of air pressure on the medicament 32 may retain the medicament 32 within the chamber 30. Gravity may not overcome the air pressure on the medicament 32, in which case the medicament 32 is retained within the chamber 30. Alternatively or additionally, a removable barrier 90 may be positioned at or near the opening 18. The barrier 90 may be pierced or otherwise removed as the medicament 32 advances outwardly from the opening 18, as described below. Additionally or alternatively, the viscosity of the medicament 32 may be high and prevent the medicament 32 from passing through the opening 18 until the actuator 50 is actuated, as described below.

[0021] In FIG. 2A , the distal portion 16 is shown in a first configuration. For example, the configuration of FIG. 2A is the configuration of the distal portion 16 prior to administering the agent 32 to the surgical site. The agent 32 may be contained in the chamber 30 distal from the piston 52. In FIG. 2B , the distal portion 16 is shown in a second configuration in which the piston 52 has moved distally from the position shown in FIG. 2A . In the second configuration, at least a portion of the agent 32 is administered to the desired site by the mechanism described below. The actuator 50 may be operated to transition the piston 52 from the first configuration to the second configuration. For example, a plunger may be depressed or another mechanism may be activated to move the piston 52 distally, as described in more detail below (see FIGS. 5A-6J ). As the piston 52 moves distally toward the opening 18, the piston 52 forces the agent 32 out of the opening 18. The piston 52 and / or chamber 30 may be configured such that when the piston 52 is advanced distally sufficiently, all or nearly all of the agent 32 may be delivered to the surgical site or another chamber through the opening 18. To avoid wasteful consumption of the agent 32, the chamber 30 may be filled with only the amount of agent 32 desired to be delivered to the surgical site. As the agent 32 is forced out of the opening 18, the force of the agent 32 (transmitted from the piston 52) may break or puncture any barrier 90 covering the opening 18.

[0022] 3A and 3B illustrate an alternative distal portion 116 that may have any of the characteristics of distal portion 16 and may be used in combination as part of delivery device 10. Distal portion 116 may facilitate mixing of a multi-component drug and delivery of the mixed drug to a surgical site. Distal portion 116 includes chamber 130 that may have any of the characteristics of chamber 30. Tube 132 may be housed within chamber 130. Tube 132 has an internal lumen defining the chamber for containing the drug, as described below. Tube 132 and chamber 130 may be coaxial / concentric or may have parallel longitudinal axes. Alternatively, the longitudinal axes of tube 132 and chamber 130 may be transverse to one another. Tube 132 may have a round cross-sectional shape or an alternative shape (e.g., square, rectangular, polygonal, elliptical, etc.). Tube 132 may be perforated such that at least the radially outer wall of tube 132 includes a plurality of holes 134. Holes 134 may have any suitable shape (e.g., round). Further details of holes 134 are provided below. Tube 132 may also optionally include a distal opening (not shown) or a distally facing wall, with or without holes 134. A first component drug 136 may be contained within chamber 130, and a second component drug 138 may be contained within the lumen of tube 132.

[0023] First piston 154 is slidably disposed within chamber 130 (or lumen 120). First piston 154 has a washer shape with a central opening, and tube 132 fits into the central opening. First piston 154 can slide around the outer surface of tube 132. Second piston 156 is disposed within the central opening of tube 132 and can be slidably disposed within tube 132. Second piston 156 can have a shape and size that fits with the central opening of first piston 154. First piston 154 can form a sealing configuration with the outer wall of tube 132 and the inner wall of chamber 130 to prevent first component drug 136 from passing proximally beyond first piston 154. Second piston 156 can form a sealing configuration with the inner wall of tube 132 to prevent second component drug 138 from moving distally beyond second piston 156. The outer circumferential surface of the first piston 154 has a shape complementary to the wall of the tube 132 , and the inner circumferential surface of the first piston 154 has a shape complementary to the outer circumferential surface of the tube 132 and the outer periphery of the second piston 156 .

[0024] In a first configuration, as shown in FIG. 3A , the tube 132 (including the bore 134) and pistons 154, 156 can be configured such that the first component drug 136 is retained within the chamber 130 (and outside the tube 132) and the second component drug 138 is retained within the tube 132. For example, the force of air pressure on the component drugs 136, 138 may hold the component drugs 136, 138 within the chamber 130 and the tube 132, respectively. The air pressure may hold the component drugs 136, 138 by having a force that exceeds gravity. The bore 134 can be sized such that surface tension or other forces of the drug 138 hold the second component drug 138 within the tube 132 without undesirable leakage through the bore 134. For example, the bore 134 can have a sufficiently small diameter and sufficient length to pass through the wall of the tube 132 so that the component drugs 136, 138 do not pass through the bore 134 until a force is applied by the piston 156. Additionally or alternatively, the viscosity of the component drugs 136, 138 may be such that they do not pass through the holes 134 until a force is applied to the piston 156. The holes 134 may also be covered by a movable / removable barrier, which may comprise any of the elements of the barrier 90. The chamber 130 may also include a barrier 190, which may comprise any of the elements of the barrier 90, at or proximal to the opening 118. The holes 134 may have a width (e.g., diameter) of approximately 0.1 microns to 2 millimeters. The holes 134 may be uniform or may vary (e.g., different sizes and / or shapes of the holes 134 may deliver the second component drug 138 at different rates). The holes 134 may be circular or have alternative shapes (e.g., oval, polygonal, slit, etc.). As described above with respect to the distal portion 16, the distal portion 116 may be pre-filled with the component drugs 136, 138. Alternatively, the user may load component drugs 136, 138 into chamber 130 and tube 132, respectively.

[0025] 3B shows a second configuration of distal portion 116 in which pistons 154, 156 have been advanced distally through chamber 130 and tube 132, respectively. Pistons 154, 156 may be configured to move together or independently to facilitate the desired mixing of first component drug 136 and second component drug 138. As piston 156 is advanced distally through tube 152, second component drug 138 may pass through bore 134 and enter chamber 130. First component drug 136 may also move distally within tube 152 as piston 154 moves distally. First component drug 136 and second component drug 138 may mix to form combined drug 140 within chamber 130. Mixing may be facilitated by the presence of an empty portion of chamber 130 distal to the distal end of tube 132. For example, the distal end of tube 132 may be proximal to opening 118. Alternatively, mixing may occur in a portion of chamber 130 that includes tube 132 passing therethrough (e.g., in a portion of chamber 130 that is emptied of first component drug 136 prior to activation of actuator 150). For example, mixing may occur in a region of chamber 130 distal to barrier 190. Distal movement of piston 154 and / or piston 156 may deliver combined drug 140 through distal opening 118 to the surgical site. Similar to distal portion 16 of FIGS. 2A-2B , distal portion 116 may facilitate dispensing all or nearly all of first and second component drugs 136, 138 (combined into combined drug 140). Distal portion 116 may thereby avoid wasteful consumption of first and second component drugs 136, 138.

[0026] 3A and 3B show one tube 132 and one chamber 130, multiple tubes 132 or chambers 130 may be used (e.g., if a mixture of three or more components is desired). An appropriate number of corresponding pistons (e.g., pistons 154, 156) may be used.

[0027] 4A and 4B illustrate another alternative distal portion 216 that may have any of the characteristics of the distal portion 16, 116 described above. The distal portion 216 may include a chamber 230 having multiple subchambers 230a, 230b. The subchambers 230a, 230b may be defined by tubes contained within the chamber 230. Alternatively, the subchambers 230a, 230b may be formed by a partition extending longitudinally between the subchambers 230a, 230b, such that the subchambers 230a, 230b are defined by the interior wall of the chamber 230 and the partition. While FIGS. 4A and 4B illustrate two subchambers 230a, 230b, any number of suitable subchambers 230a, 230b may be used. The subchambers 230a, 230b may be parallel to one another or transverse to one another. Subchambers 230a, 230b may each include an opening at its distal end. First component drug 236 may be contained in first subchamber 230a, and second component drug 238 may be contained in second subchamber 230b. As shown in FIGS. 4A and 4B, subchambers 230a, 230b may be approximately the same size, or subchambers 230a and 230b may be different sizes. For example, if it is desired to use more first component drug 236 than second component drug 238, subchamber 230a may be larger than subchamber 230b. Subchambers 230a, 230b may have a uniform cross-section or may have variable cross-sections designed to provide a desired mixing ratio of first component drug 236 and second component drug 238.

[0028] First piston 252a may be slidably disposed within first subchamber 230a. Second piston 252b may be slidably disposed within second subchamber 230b. First piston 252a may form a sealing configuration with the inner surface of first subchamber 230a, and second piston 252b may form a sealing configuration with the inner surface of second subchamber 230b. First piston 252a may be movable together with or independently of second piston 252b. As first piston 252a and / or second piston 252b advance distally, first component drug 236 and / or second component drug 238 may advance distally, respectively. First component drug 236 and second component drug 238 may mix to form combined drug 240 in a portion of chamber 230 distal from the distal openings of subchambers 230a, 230b. Combined drug 240 may be forced out of distal opening 218 as pistons 252a, 252b advance distally. Similar to distal portions 16, 116 of FIGS. 2A-3B, distal portion 216 may facilitate dispensing all or nearly all of the combined first component drug 236 and second component drug 238 into combined drug 240. Distal portion 216 may thereby avoid waste of first component drug 236 and second component drug 238.

[0029] Prior to advancing pistons 252a, 252b, first and second component drugs 236, 238 may be held within subchambers 230a, 230b, respectively, by pneumatic or viscous forces of component drugs 236, 238, as described above with respect to Figures 2A-3B. Additionally or alternatively, membranes 290a, 290b may be disposed at or near the distal ends of subchambers 230a, 230b. Membrane 290 may have any of the properties of membrane 90. Also, a membrane (not shown) may be disposed at or near opening 218 and may have any of the elements of membrane 90.

[0030] Although Figures 4A and 4B show two subchambers 230a, 230b, any number of subchambers may be used with an appropriate number of corresponding pistons. Figures 5A-6J show exemplary mechanisms for actuating the pistons of the distal sections depicted in Figures 2A-4B. Alternatively, the elements of Figures 5A-6J may be used independently of the distal sections of Figures 2A-4B. Similarly, the distal sections of Figures 2A-4B may be used with mechanisms different from those described below with respect to Figures 5A-6J. While some of the actuation mechanisms below are described as being compatible with some of the distal sections described above, this compatibility is not intended to be limiting, and various combinations of aspects of the distal sections and actuation mechanisms may be used. Wherever possible, like reference numerals will be used to indicate corresponding structures.

[0031] 5A and 5B show cross-sectional views of an example delivery device 300 that may include any of the elements of delivery device 10. Delivery device 300 includes a handle 312 (e.g., a control portion) and a sheath 314 (e.g., an insertion portion). Sheath 314 may include a catheter 315 or other suitable components. Lumen 320 may extend from a proximal portion of catheter 315 to a distal end of catheter 315.

[0032] The sheath 314 also includes a distal portion 316. The distal portion 316 may be a separate component from the catheter 315 or may be a single, integral structure with the catheter 315. The distal portion 316 may be fixedly or removably attached to the distal end of the catheter 315. The distal portion 316 may be configured to house a drug 332. The distal portion 316 may have any of the characteristics of the distal portions 16, 116, and 216 described above. While the distal portion 316 is shown as having one chamber 330, multiple chambers may be used, as shown, for example, in FIGS. 3A-4B. The chamber 330 may terminate in a distal opening 318. The drug 332 may be contained in the chamber 330. A piston 352 is slidable within the chamber 330 and may have any of the characteristics of any of the pistons described above with respect to FIGS. 2A-4B.

[0033] The example of Figures 5A-5B may utilize a pneumatic drive mechanism to slidably move piston 352 within chamber 330. The drive mechanism of Figures 5A-5B may be used in combination with the drive mechanism of Figures 6A-6J, described below. Additionally, the drive mechanism of Figures 5A-5B may be used with device 10 including any of distal ends 16, 116, 216.

[0034] Handle 312 includes plunger 350. Plunger 350 is operably connected to piston 354 via stem 356. While piston 354 is shown disposed within handle 312, piston 354 may also be disposed within sheath 314. Handle 312 includes lumen 322 in which piston 354 is slidably disposed. Piston 354 may form a sealing configuration with a surface of lumen 322. Lumen 322 may have a larger cross-sectional diameter than lumen 320, as shown in FIG. 5A. Alternatively, lumen 322 may have the same cross-sectional diameter as lumen 320 or may have a smaller cross-sectional diameter than lumen 320. A larger cross-sectional lumen 322 may allow device 300 to have a shorter stem 356.

[0035] Fluid 370 may be disposed within lumen 322 distal from piston 354 and proximal to piston 352. Pistons 352, 354 may include elements for a sealing arrangement to retain fluid 370 between pistons 352, 354. FIG. 5A shows delivery device 300 in a first configuration in which plunger 350 is not depressed and medicament 332 is not dispensed through opening 318. FIG. 5B shows delivery device 300 in a second configuration in which plunger 350 is at least partially depressed and at least a portion of medicament 332 has been dispensed through opening 318. As plunger 350 is depressed / advanced distally, piston 354 may advance a corresponding (e.g., equal) amount. Plunger 350 may impart a force to fluid 370 to advance fluid 370 distally. Fluid 370 may exert a force on piston 352, which in turn may advance medicament 332 through opening 318, as described above with respect to Figures 1-4B.

[0036] Fluid 370 may be incompressible or compressible. For example, if fluid 370 is incompressible, when plunger 350 is depressed, medicament 332 may be dispensed immediately or nearly immediately from opening 318. If fluid 370 is compressible, when fluid 370 is depressed, there may be a delay between depression of plunger 350 and dispensing of medicament 332 from opening 318. Fluid 370 may include any suitable fluid. For example, fluid 370 may be biocompatible and may include saline.

[0037] The use of fluid 370 as a driving mechanism may allow sheath 314 to be flexible to pass through the working channel of an endoscope and through tortuous body lumens of a subject. This flexibility of sheath 314 facilitates positioning of agent 332 in distal portion 316 so that agent 332 is not wasted.

[0038] 6A-6J illustrate alternative drive mechanisms. FIG. 6A illustrates a delivery device 400 that may have any of the characteristics of delivery devices 10, 300. Delivery device 400 includes a handle 412 (e.g., a control portion) and a sheath 414 (e.g., an insertion portion). Sheath 414 may include a catheter 415 or another suitable component. Lumen 420 may extend from a proximal portion of catheter 415 to a distal end of catheter 415 (see, e.g., FIGS. 6A-6B).

[0039] The sheath 414 may also include a distal portion 416. The distal portion 416 may be a separate component from the catheter 415 or may be a single, integral structure with the catheter 415. The distal portion 416 may be fixedly or removably attached to the distal end of the catheter 415. The distal portion 416 may be configured to house a medication. The distal portion 416 may have any of the characteristics of the distal portions 16, 116, 216, 316 described above. Figures 6C, 6E, 6F, 6H, and 6J below show exemplary distal portions 464, 466, 468, 470, 472 that may be used in place of the distal portion 416. Elements of the distal portions 16, 116, 216, 316 may be used in combination with any of the elements of the distal portions 464, 466, 468, 470, 472, and corresponding structures are identified with similar reference numbers.

[0040] The handle 412 includes a plunger 450 operably connected to a finger loop 462. The plunger 450 may have components within the lumen 420. The handle 412 may also include a proximal thumb loop 464. The plunger 450 may be advanced distally by advancing the finger loop 462 distally over the body 465 of the handle 412. Elements of the handle 412 may also be used with the handles 12, 312 described above. The plunger 450 may be operably connected (e.g., mechanically coupled) to a drive mechanism described herein with respect to FIGS. 6B-6J. Elements of the handle 412, including the finger loop 462 and thumb loop 464, may also be used with the devices 10, 300 described above.

[0041] FIG. 6B illustrates a first exemplary drive mechanism 481 in cross section along line AA shown in FIG. 6A. FIG. 6C illustrates an exemplary cross-sectional view of a distal portion 464 that may be used in combination with the drive mechanism of FIG. 6B. As shown in FIG. 6B, the drive mechanism may include a wire 482 located within the lumen 420 of the sheath 414. A proximal portion of the wire 482 may be operably coupled to the plunger 450 by, for example, crimping, soldering, gluing, or other fastening mechanism. Alternatively, the wire 482 and the plunger 450 may be formed of a single, integral material. A distal portion of the wire 482 may be operably connected (e.g., mechanically connected) to a piston 452 that is slidable within the chamber 430. The wire 482 may be crimped, soldered, glued, or otherwise secured to the piston 452. Alternatively, the wire 482 and the piston 452 may be formed of a single, integral material. Wire 482 may be made of a flexible material such as nitinol, stainless steel, flexible plastic, polymer, braided coil, nylon 12, or any other suitable material. Wire 482 may be sufficiently rigid to transfer force from the movement of plunger 450 to piston 452. However, wire 482 may also be sufficiently flexible so as not to inhibit or nearly inhibit the flexibility of sheath 414. Although the term "wire" is used, wire 482 may include structures made of materials such as plastic.

[0042] When plunger 450 is advanced distally, wire 482 advances piston 452 and can transmit at least one of force and motion to piston 452 that can result in the dispensing of medication, as described above (e.g., with respect to Figures 2A-2B).

[0043] Figure 6D shows another exemplary drive mechanism 483 in cross section along line AA shown in Figure 6A. Figures 6E and 6F show exemplary distal portions 466, 468 that can be used in combination with the drive mechanism of Figure 6D. As shown in Figure 6D, the drive mechanism can include a tube 484 located within the lumen 420 of the sheath 414. A proximal portion of the tube 484 can be operably coupled to the plunger 450 by, for example, crimping, soldering, adhesive bonding, or other fastening mechanism. Alternatively, the tube 484 and the plunger 450 can be formed of a single, integral material. The tube 484 can have a central lumen or opening extending longitudinally therethrough.

[0044] As shown in FIG. 6E, the drive mechanism 483 may be used in combination with a distal portion 466, which may be similar to and have any of the characteristics of the distal portion 16 of FIGS. 2A-2B. The distal portion 466 may include a chamber 430, and the piston 452 may be slidably disposed within the chamber 430. The distal portion of the tube 484 may be operably connected (e.g., mechanically connected) to the piston 452. The tube 484 may be crimped, soldered, glued, or otherwise secured to the piston 452. Alternatively, the tube 484 and the piston 452 may be formed of a single, integral material. The tube 484 may be fabricated from a flexible material, such as a plastic material, nitinol, a flexible polymer, a braided coil, or other suitable material. The tube 484 may be sufficiently rigid to transfer force from the movement of the plunger 450 to the piston 452. However, the tube 484 may be sufficiently flexible so as not to impede or nearly impede the flexibility of the sheath 414. Although the tube 484 is shown as having a hollow central core, the tube 484 may also have a solid cross section, a lattice cross section, or the like.

[0045] As plunger 450 advances distally, tube 484 advances piston 452 and can transmit force from plunger 450 to piston 452, which can lead to the dispensing of medication, as described above (e.g., with respect to Figures 2A-2B).

[0046] As shown in FIG. 6F, the drive mechanism 483 may be used in combination with a distal portion 468, which may be similar to or include any of the elements of the distal portion 216 of FIGS. 4A-4B. The distal portion 468 may include a first chamber 430a and a second chamber 430b. A first piston 452a may be slidably disposed within the first chamber 430a, and a second piston 452b may be slidably disposed within the second chamber 430b. The distal portion of the tube 484 may be operably connected (e.g., mechanically connected) to the first piston 452a and the second piston 452b. The tube 484 may be crimped, soldered, glued, or otherwise secured to the first piston 452a and the second piston 452b. Alternatively, the tube 484 and the pistons 452a, 452b may be formed of a single, integral material. The tube 482 may include slots or other elements (not shown) to accommodate the walls of the first chamber 430a and the second chamber 430b between the first chamber 430a and the second chamber 430b.

[0047] As plunger 450 advances distally, tube 484 advances pistons 452a, 452b and can transmit forces from plunger 450 to both pistons 452a, 452b, which can lead to the dispensing of medication, as described above (e.g., with respect to Figures 4A-4B).

[0048] Figure 6G shows another exemplary drive mechanism 486 in cross section along line AA shown in Figure 6A. Figure 6H shows an exemplary cross-sectional view of a distal portion 470 that may be used in combination with the drive mechanism of Figure 6G. The distal portion 470 may include a first chamber 430a and a second chamber 430b. A first piston 452a may be slidably disposed within the first chamber 430a, and a second piston 452b may be slidably disposed within the second chamber 430b.

[0049] As shown in FIG. 6G, actuation mechanism 486 includes wires 482a and 482b located within lumen 420 of sheath 414. While FIG. 6G shows two wires 482a and 482b, any suitable number of wires may be used. A proximal portion of each of wires 482a, 482b may be operably coupled to plunger 450 by, for example, crimping, soldering, adhesive bonding, or other fastening mechanism. Alternatively, wires 482a, 482b and plunger 450 may be formed of a single, integral material. Wires 482a and 482b may be independently movable, for example, by multiple plungers (not shown).

[0050] A distal portion of wire 482a may be operably connected (e.g., mechanically connected) to first piston 452a. Wire 482a may be crimped, soldered, glued, or otherwise secured to first piston 452a. Alternatively, wire 482a and first piston 452a may be formed of a single, integral material. A distal portion of wire 482b may be operably connected (e.g., mechanically connected) to second piston 452b. Wire 482b may be crimped, soldered, glued, or otherwise secured to second piston 452b. Alternatively, wire 482b and second piston 452b may be formed of a single, integral material.

[0051] Wires 482a, 482b may have any of the characteristics of wire 482 described above. When plunger 450 is advanced distally, wire 482a may transmit force and / or motion to first piston 452a, advancing first piston 452a. Simultaneously (unless wires 482a and 482b are controlled separately), wire 482b may transmit force and / or motion of plunger 450 to second piston 452b. Advancing plunger 450 distally may result in dispensing of medicament, as described above (e.g., with respect to FIGS. 4A-4B).

[0052] Figure 6I illustrates another exemplary drive mechanism 488 in cross section along line AA shown in Figure 6A, and Figure 6J illustrates an exemplary cross-sectional view of a distal portion 472 that may be used in combination with drive mechanism 488. Distal portion 472 may have any of the characteristics of distal portion 116 described above with respect to Figures 3A-3B. Distal portion 472 includes a chamber 430 and a tube 432. A first piston 454 may be slidably disposed within chamber 430, and a second piston 456 may be slidably disposed within tube 432.

[0053] As shown in FIG. 6I , the drive mechanism 488 may include a wire 482 that may be located within the lumen 420 of the sheath 414 and may have any of the characteristics described above with respect to FIG. 6B . A proximal portion of the wire 482 may be operably coupled to the plunger 450 by, for example, crimping, soldering, adhesive bonding, or other fastening mechanism. Alternatively, the wire 482 and plunger 450 may be formed of a single, integral material. The drive mechanism 488 also includes a tube 484 that is located within the lumen 420 of the sheath 414 and may have any of the characteristics described above with respect to FIGS. 6D-6F . A proximal portion of the tube 484 may be operably coupled to the plunger 450 by, for example, crimping, soldering, adhesive bonding, or other fastening mechanism. Alternatively, the tube 484 and plunger 450 may be formed of a single, integral material. Alternatively, the wire 482 and the tube 484 may be independently movable. The wire 482 may be located within the tube 484. For example, wire 482 may be coaxial with or parallel to the central longitudinal axis of tube 484 .

[0054] A distal portion of the wire 482 may be operably connected (e.g., mechanically connected) to the first piston 456. The wire 482 may be crimped, soldered, glued, or otherwise secured to the first piston 456. Alternatively, the wire 482 and the first piston 456 may be formed of a single, integral material. A distal portion of the tube 484 may be operably connected (e.g., mechanically connected) to the second piston 454. The tube 484 may be crimped, soldered, glued, or otherwise secured to the second piston 454. Alternatively, the tube 484 and the piston 454 may be formed of a single, integral material.

[0055] As plunger 450 is advanced, wire 482 may transmit force from plunger 450 to piston 456, and tube 484 may transmit force from plunger 450 to piston 454. Distal advancement of plunger 450 may result in dispensing of medication, as described above (e.g., with respect to Figures 3A-3B).

[0056] While the principles of the present disclosure have been described herein with reference to illustrative examples of particular applications, the present invention is not limited to those examples. Those skilled in the art with access to the teachings provided herein will recognize that further modifications, applications, and substitutions of equivalents are all within the scope of the embodiments described herein. Accordingly, the present invention should not be deemed limited by the foregoing description.

Claims

1. The handle and a flexible sheath extending from the handle, The sheath a first chamber configured to contain a first agent and a second chamber configured to contain a second agent, the first chamber and the second chamber being disposed in a distal portion of the sheath; a first piston housed in the first chamber and a second piston housed in the second chamber; at least one drive element configured to transmit force from the handle to each of the first piston and the second piston; A medical device, wherein when the handle is in a first configuration, the first agent is held in the first chamber and the second agent is held in the second chamber, and when the handle is in a second configuration, the first agent is released from the first chamber and mixed with the second agent.

2. The medical device of claim 1 , wherein the second chamber is defined by a tube disposed within the first chamber.

3. The medical device of claim 2 , wherein the wall of the tube comprises a plurality of pores.

4. The medical device of claim 2 or 3, wherein the distal-most end of the tube is proximal to an opening in the distal-most end of the sheath.

5. The medical device of any one of claims 2 to 4, wherein the central longitudinal axis of the tube is substantially coaxial with the central longitudinal axis of the first chamber.

6. 6. The medical device of claim 2, wherein the first piston has an outer periphery and an inner periphery, and the second piston has an outer periphery having a shape complementary to the shape of the inner periphery of the first piston.

7. 7. The medical device of claim 2, wherein the first drive element is a tube operably connected to the first piston, the tube including at least one slot for accommodating the tube.

8. 2. The medical device of claim 1, wherein the at least one drive element comprises: a first flexible drive element having a proximal end operably coupled to the handle and a distal end operably coupled to the second piston; and a second flexible drive element having a proximal end operably coupled to the handle and a distal end operably coupled to the second piston.

9. The medical device of claim 8 , wherein the first drive element comprises a wire.

10. The medical device of claim 9 , wherein the second drive element comprises a wire or a tube.

11. The medical device of claim 10 , wherein the wire of the first drive element is disposed within the lumen of the tube of the second drive element.

12. The medical device of any one of claims 1 to 11, wherein the sheath includes at least one barrier that prevents release of the first agent from the first chamber.

13. The medical device of any one of claims 1 to 12, wherein the at least one drive element comprises a pneumatic fluid.

14. The medical device of any one of claims 1 to 13, wherein the first chamber is pre-filled with the first agent and the second chamber is pre-filled with the second agent.

15. The medical device of any one of claims 1 to 14, wherein a distal portion of the sheath is removably attached to the remainder of the sheath.

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