Medicament delivery device

Abstract

A medical device may include a handle and a flexible sheath extending from the handle. The sheath may include a first chamber configured to receive a first medicament and a second chamber configured to receive a second medicament. 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 received within the first chamber and a second piston received 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 medicament may be maintained within the first chamber and the second medicament may be maintained within the second chamber. When the handle is in the second configuration, the first medicament may be released from the first chamber to mix with the second medicament.

Description

This application is a divisional of the Chinese application with application date of December 2, 2020, application number 202080095362.7, and invention name “Drug Delivery Device”. CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority to U.S. Provisional Patent Application No. 62 / 942,887, filed on December 3, 2019, the entire contents of which are incorporated herein by reference. Technical Field

[0002] The present invention relates generally to drug delivery devices. More particularly, the present invention relates to catheter devices for endoscopically delivering one or more drugs. Background Art

[0001] The agent may 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 the endoscope during the procedure using a handle of the endoscope. Tools are passed through a working channel of the endoscope via, for example, a port in the handle to deliver therapy at a surgical site near the distal end of the endoscope. The surgical site is distal to the operator.

[0002] During endoscopic surgery, a medicament may be delivered through a device that is inserted into the working channel of an endoscope. If the medicament is introduced into the device at the proximal end, a port, some of the medicament will remain in the portion within the working channel of the device and will not be delivered to the surgical site. However, the user may desire to deliver all or nearly all of the medicament, rather than leaving the remaining medicament in the device. Therefore, there is a need for a medicament delivery device. Summary of the invention

[0003] Examples of the invention relate, among other things, to drug delivery devices.Each of the examples disclosed herein may include one or more of the features described in conjunction with the disclosed examples.

[0004] In one example, a medical device may include a handle and a flexible sheath extending from the handle. The sheath may include a first chamber configured to receive a first medicament and a second chamber configured to receive a second medicament. 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 received in the first chamber and a second piston received in the second chamber, and at least one actuating element configured to transfer force from the handle to each of the first piston and the second piston. When the handle is in the first configuration, the first medicament may be maintained in the first chamber and the second medicament may be maintained in the second chamber. When the handle is in the second configuration, the first medicament may be released from the first chamber to mix with the second medicament.

[0005] Any of the exemplary medical devices disclosed herein may include any of the following features. The second chamber may be defined by a tube disposed within the first chamber. The wall of the tube may include a plurality of holes. The distal end of the tube may be proximal to the opening in the distal end of the sheath. The central longitudinal axis of the tube may be substantially coaxial with the central longitudinal axis of the first chamber. The first piston may have an outer perimeter and an inner perimeter. The second piston may have an outer perimeter whose shape is complementary to the shape of the inner perimeter of the first piston. The first actuating element may be a tube defining a cavity. The second actuating element may be a wire within the cavity. At least one actuating element may include a first flexible actuating element having a proximal end operably coupled to a handle and a distal end operably coupled to a second piston; and a second flexible actuating element having a proximal end operably coupled to a handle and a distal end operably coupled to a second piston. The first actuating element may include a wire. The second actuating element may include a wire or a tube. The wire of the first actuating element may be disposed within the cavity of the tube of the second actuating element. The sheath may include at least one barrier that prevents the first medicament from being released from the first chamber. At least one actuation element may include a pneumatic fluid. The first chamber may be preloaded with a first medicament. The second chamber may be preloaded with a second medicament. The 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. The distal portion of the sheath may include: a first chamber configured to receive a first medicament and a tube disposed in the first chamber. The tube may have an inner cavity defining a second chamber. The wall of the tube may include a plurality of holes. The distal portion of the sheath may also include at least one actuating element operable to transfer a force from the actuator to each of a first piston received in the first chamber and a second piston received in the second chamber. Each of the plurality of holes may be configured to isolate the first medicament from the second medicament when the at least one actuating element does not receive a force, and to release the second medicament from the second chamber through the plurality of holes to mix with the first medicament when the at least one actuating element receives a force.

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

[0008] In another example, a 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 receive a first medicament and a second chamber configured to receive a second medicament, 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 received in the first chamber and a second piston received in the second chamber; and a tube configured to transmit a force from the actuator to at least one of the first piston and the second piston.

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

[0010] It is to be understood that the above general description and the following detailed description are merely exemplary and explanatory of the invention as claimed, rather than restrictive descriptions. As used herein, the terms "include", "comprises" or any other variations thereof are intended to encompass non-Y content, so that the process, method, article or equipment comprising a list of elements not only includes those elements, but may include other elements that are not explicitly listed or are not inherent to such process, method, article or equipment. The term "exemplary" is used in the sense of "example" rather than "exemplary". The term "distal" refers to the direction away from the operator, and the term "proximal" refers to the direction toward the operator. The term "approximately" or similar terms (e.g., "substantially") include values ​​of + / -10% of the value. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] 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.

[0012] Figure 1 An exemplary drug delivery device is shown.

[0013] Figures 2A to 4B Shows Figure 1 An exemplary distal end of a drug delivery device.

[0014] Figures 5A to 5B Another exemplary drug delivery device is shown.

[0015] Figures 6A to 6J Other exemplary drug delivery devices are shown. DETAILED DESCRIPTION

[0016] The drug delivery device can be configured to contain the drug at the distal end of the delivery device so that after the drug is deployed to the treatment site, the amount of drug retained in the delivery device is minimal and waste of the drug is avoided. The delivery device can be configured to contain a single component drug or a multi-component drug. In the case of a multi-component drug, the delivery device can be configured to allow mixing of the components before delivery from the device. Various mechanisms can be utilized to actuate the delivery device to deliver the drug. These mechanisms can include pneumatic devices, wires, tubes, or any suitable combination thereof.

[0017] Figure 1 An exemplary delivery device 10 is depicted. The delivery device 10 may include a handle 12 (which may be an operating portion) and a sheath 14 (which may be an insertion portion). The sheath 14 may include a catheter 15 or other suitable component. The sheath 14, or at least a component of the sheath 14 (such as the catheter 15), may be flexible so that the sheath 14 may be advanced through a working channel of an endoscope in a body cavity, which may be tortuous. The cross-sectional diameter of the sheath 14 may be such that the sheath 14 may be advanced through a working channel of an endoscope. The cavity 20 (see Figures 2A to 4B ) can extend from the proximal portion of the catheter 15 to the distal end of the catheter 15.

[0018] The sheath 14 may also include a distal portion 16. The distal portion 16 may be a separate component from the catheter 15, or may be a single integral structure 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 the working channel of the 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, for example, to contain a medicament within a compartment. The distal portion 16 may have various configurations, as described herein. Figures 2A to 4B discussed.

[0019] Figures 2A to 4B A cross-sectional view of an exemplary distal portion 16, 116, 216 of a delivery device 10 is shown. The features of the distal portion 16, 116, 216 may be combined with one another in any suitable combination. Where possible, the same reference numerals are used to indicate corresponding structures.

[0020] Figure 2A and 2BAn example distal portion 16 is shown. The distal portion 16 may include a chamber 30 for containing a medicament 32. The chamber 30 may be defined by the same surface that defines the cavity 20. For example, the inner surface of the catheter 15 may define the cavity 20 and the chamber 30 in a configuration where the distal portion 16 is a single integral structure with the catheter 15. Alternatively, the chamber 30 may be defined by other surfaces. Although the chamber 30 is shown as occupying the entire cross-sectional width of the cavity defined by the distal portion 16, the chamber 30 may also be a subset of the distal portion 16. For example, a tube or similar structure may be disposed within the distal portion 16, and the chamber 30 may be located within the tube or other structure. The opening 18 may be in fluid communication with the chamber 30 so that the medicament 32 may pass through the opening 18 when desired by the user, as described below.

[0021] The piston 52 may be slidably received within at least one of the chamber 30 and the cavity 20. The piston 52 may be provided with a seal to prevent the medicament 32 from moving proximally past the piston 52. The piston 52 may be configured to move proximally and / or distally within the chamber 30. The handle 12 ( Figure 1 ) can be used to move the piston 52. The actuator 50 may include a plunger, such as Figure 1 As shown, or alternative structures, such as those discussed below. For example, actuator 50 may include a knob, a button, a switch, a lever, a slider, or another structure. Figures 5A to 6J Exemplary mechanisms for operably connecting actuator 50 to piston 52 are discussed in greater detail.

[0022] The medicament 32 can be any suitable type of medicament in any suitable form. The medicament 32 can be a gel, a liquid, a powder, etc. For example, the medicament 32 can include a hemostatic agent, a coagulant, a medicine or other drug, etc. The medicament 32 can be preloaded in the distal portion 16. In the case of preloaded medicament 32, the delivery device 10 or a portion of the delivery device 10 can be disposable. Alternatively, the 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 withdrawing the actuator 50 to move the piston 52 proximally. The distal portion 16 may include a mark or other indication of how much medicament 32 has been loaded into the distal portion 16 or how much medicament 32 has been dispensed from the distal portion 16. The distal portion 16 can be removably attached to the catheter 15 (e.g., via threads, snap fit, or other mechanisms) so that the distal portion 16 preloaded with the medicament 32 in the compartment 30 can be attached to a reusable (or disposable) catheter 15 prior to use. After the medicament 32 has been dispensed from the opening 18, the distal portion 16 can be replaced with a new preloaded distal portion 16, as described below.

[0023] The medicament 32 may be retained within the chamber 30 by various mechanisms. For example, the force of air pressure on the medicament may retain the medicament 32 within the chamber 30. Gravity may not be able to overcome the air pressure of the medicament 32, resulting in the medicament 32 being retained within the chamber 30. Alternatively or additionally, a removable barrier 90 may be disposed at or near the opening 18. When the medicament 32 is pushed out of the opening 18 as discussed below, the barrier 90 may be pierced or otherwise removed. Additionally or alternatively, the viscosity of the medicament 32 may be high enough that the medicament 32 does not pass through the opening 18 until the actuator 50 is manipulated, as described below.

[0024] exist Figure 2A , the distal portion 16 is shown in a first configuration. For example, Figure 2A The configuration of the distal portion 16 may be the configuration of the distal portion 16 prior to applying any agent 32 to the surgical site. The agent 32 may be contained in the chamber 30, distal to the piston 52. Figure 2B , the distal portion 16 is shown in a second configuration in which the piston 52 has been moved from Figure 2A In the second configuration, at least some of the medicament 32 may have been administered to the desired site by the mechanism described below. To convert the piston 52 from the first configuration to the second configuration, the actuator 50 may be manipulated. For example, the plunger may be depressed or another mechanism may be activated to move the piston 52 distally, as described in more detail below (see Figures 5A to 6J ). When the piston 52 moves distally toward the opening 18, the piston 52 can push the medicament 32 out of the opening 18. The piston 52 and / or the chamber 30 can be configured so that when the piston 52 is fully advanced distally, all or nearly all of the medicament 32 can be delivered to the surgical site or to another chamber via the opening 18. Only an amount of the medicament 32 that is desired to be delivered to the surgical site can be loaded into the chamber 30 to avoid wasting the medicament 32. When the medicament 32 is pushed out of the opening 18, the force of the medicament 32 (transmitted from the piston 52) can destroy or otherwise pierce any barrier 90 on the opening 18.

[0025] Figure 3A and 3BAn alternative distal portion 116 is shown, which may have any of the properties of the distal portion 16 and may be used in conjunction with a portion of the delivery device 10. The distal portion 116 may facilitate mixing of a multi-component medicament and delivery of the mixed medicament to a surgical site. The distal portion 116 may include a chamber 130, which may have any of the properties of the chamber 30. A tube 132 may be housed within the chamber 130. As described below, the tube 132 may have an inner cavity defining a chamber for receiving the medicament. The tube 132 and the chamber 130 may be coaxial / concentric or may have parallel longitudinal axes. Alternatively, the longitudinal axes of the tubes 132 and 130 may be transverse to each other. The tube 132 may have a circular cross-sectional shape or an alternative shape (e.g., square, rectangular, polygonal, elliptical, etc.). The tube 132 may be fenestrated so that at least the radially outer wall of the tube 132 includes a plurality of holes 134. The hole 134 may have any suitable shape (e.g., a circular shape). Further details of the aperture 134 are provided below. The tube 132 may also optionally include a distal opening (not shown), or a distally facing wall with or without the aperture 134. A first component medicament 136 may be contained within the chamber 130, and a second component medicament 138 may be contained within the lumen of the tube 132.

[0026] The first piston 154 can be slidably disposed in the chamber 130 (or cavity 120). The first piston 154 can have a washer shape with a central opening so that the tube 132 fits in the central opening. The first piston 154 can slide movably around the outer surface of the tube 132. The second piston 156 can be disposed in the central opening of the tube 132 and slidably disposed in the tube 132. The second piston 156 can have a shape and size that matches the central opening of the first piston 154. The first piston 154 can form a seal with the outer wall of the tube 132 and the inner wall of the chamber 130 to prevent the first component medicament 136 from passing through the first piston 154 to the proximal side. The second piston 156 can form a seal with the inner wall of the tube 132 so that the second component medicament 138 does not move distally through the second piston 156. The outer perimeter of the first piston 154 may have a shape complementary to the wall of the tube 132 , and the inner perimeter of the first piston 154 may have a shape complementary to the outer surface of the tube 132 and the outer perimeter of the second piston 156 .

[0027] In the first form, Figure 3AAs shown, the tube 132 (including the hole 134) and the pistons 154, 156 can be configured so that the first component agent 136 can be kept in the chamber 130 (and outside the tube 132), and the second component agent 138 can be kept in the tube 132. For example, the force of the air pressure on the component agents 136, 138 can keep the component agents 136, 138 in the component 130 and the tube 132, respectively. The air pressure can keep the component agents 136, 138, because such air pressure can have a force that exceeds gravity. The size of the hole 134 can be set so that the surface tension or other forces of the agent 138 keep the second component agent 138 in the tube 132 without undesirable leakage through the hole 134. For example, the hole 134 can have a small enough diameter and a sufficient length to pass through the wall of the tube 132 so that the component agents 136, 138 will not pass through the hole 134 until the force is applied by the piston 156. Additionally or alternatively, the viscosity of the component agents 136, 138 may be such that they do not pass through the hole 134 until force is applied by the piston 156. The hole 134 may also be covered by a movable / removable barrier, which may have any of the features of the barrier 90. The chamber 130 may also include a barrier 190 at or near the opening 118, which may have any of the features of the barrier 90. The width (e.g., diameter) of the hole 134 may be about 0.1 microns to 2 millimeters. The hole 134 may be uniform or may vary (e.g., holes 134 of different sizes and / or shapes may deliver the second component agent 138 at a varying rate). The hole 134 may be circular or may have an alternative shape (e.g., elliptical, polygonal, slit, etc.). As described above with respect to the distal portion 16, the distal portion 116 may be preloaded with the component agents 136, 138. Alternatively, a user may load the component doses 136, 138 within the chamber 130 and the tube 132, respectively.

[0028] Figure 3BA second configuration of the distal portion 116 is shown, wherein the pistons 154, 156 have been advanced distally through the chamber 130 and the tube 132, respectively. The pistons 154, 156 can be configured to move together or independently to promote the desired mixing of the first component medicament 136 and the second component medicament 138. When the piston 156 is advanced distally through the tube 152, the second component medicament 138 can enter the chamber 130 through the hole 134. Due to the distal movement of the piston 154, the first component medicament 136 can also move distally in the tube 152. The first component medicament 136 and the second component medicament 138 can be mixed together to form a combined medicament 140 in the chamber 130. Mixing can be promoted by the empty portion of the chamber 130 that exists at the distal end of the tube 132. For example, the distal end of the tube 132 can be on the proximal side of the opening 118. Alternatively, mixing may occur in a portion of chamber 130 that includes tube 132 therethrough (e.g., in a portion of chamber 130 that is devoid of first component medicament 136 prior to activation of actuator 150). For example, mixing may occur in an area of ​​chamber 130 that is distal to barrier 190. Distal movement of piston 154 and / or piston 156 may cause combined medicament 140 to pass through distal opening 118 and be delivered to the surgical site. Figures 2A to 2B Like the distal portion 16 of the embodiment, the distal portion 116 can promote the dispensing of all or substantially all of the first component medicament 136 and the second component medicament 138 that are combined into the combined medicament 140. Therefore, the distal portion 116 can avoid the waste of the first component medicament 136 and the second component medicament 138.

[0029] although Figure 3A and 3B One tube 132 and one chamber 130 are shown, but it is understood that more than one tube 132 or chamber 130 may be used (eg, if a mixture of three or more components is desired). An appropriate number of corresponding pistons (eg, pistons 152, 154) may be used.

[0030] Figure 4A and 4B Another alternative distal portion 216 is shown that can have any of the properties of the distal portions 16, 116 described above. The distal portion 216 can include a chamber 230 having a plurality of subchambers 230a, 230b. The subchambers 230a, 230b can be defined by tubes contained within the chamber 230. Alternatively, the subchambers 230a, 230b can be formed by a partition extending longitudinally between the subchambers 230a, 230b, such that the subchambers 230a, 230b are defined by the inner wall of the chamber 230 and by the partition. Although Figure 4A and 4BTwo sub-chambers 230a, 230b are shown, but it should be understood that any number of suitable sub-chambers 230a, 230b may be used. The sub-chambers 230a, 230b may be parallel to each other or may be transverse to each other. Each of the sub-chambers 230a, 230b may include an opening at its distal end. The first component medicament 236 may be contained in the first sub-chamber 230a, and the second component medicament 238 may be contained in the second sub-chamber 230b. Figure 4A and 4B As shown, the sub-chambers 230a and 230b may be of substantially the same size, or the sub-chambers 230a and 230b may be of different sizes. For example, when it is desired to use more first component agent 236 than second component agent 238, sub-chamber 230a may be larger than chamber 230b. Sub-chambers 230a, 230b may have uniform cross-sections or may have variable cross-sections designed to achieve a desired mixing ratio of first component agent 236 to second component agent 238.

[0031] The first piston 252a may be slidably disposed within the first sub-chamber 230a. The second piston 252b may be slidably disposed within the second sub-chamber 230a. The first piston 252a may form a seal with the inner surface of the first sub-chamber 230a, and the second piston 252b may form a seal with the inner surface of the second sub-chamber 230b. The first piston 252a may move together or independently with the second piston 252b. When the first piston 252a and / or the second piston 252b are pushed distally, the first component medicament 236 and / or the second component medicament 238 may be pushed distally, respectively. The first component medicament 236 and the second component medicament 238 may be mixed to form a combined medicament 240 in a portion of the chamber 230 located distal to the distal openings of the sub-chambers 230a, 230b. When the pistons 252a, 252b are pushed distally, the combined medicament 240 may be pushed out of the distal opening 218. Figures 2A to 3B Like the distal portions 16, 116 of the present invention, the distal portion 216 can facilitate the dispensing of all or substantially all of the first component medicament 236 and the second component medicament 238 that are combined into the combined medicament 240. Therefore, the distal portion 216 can avoid the waste of the first component medicament 236 and the second component medicament 238.

[0032] Before the pistons 252a, 252b are advanced, the first component agent 236 and the second component agent 238 may be retained in the sub-chambers 230a, 230b, respectively, due to the force of gas pressure or the viscosity of the component agents 236, 238, as described above with respect to Figures 2A to 3BAdditionally 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. A membrane (not shown) may also be disposed at or near opening 218 and may have any of the features of membrane 90.

[0033] Although Figure 4A and 4B Two sub-chambers 230a, 230b are shown, but it will be appreciated that any number of sub-chambers and a suitable number of corresponding pistons may be used.

[0034] Figures 5A to 6J Shown for actuation Figures 2A to 4B Alternatively, Figures 5A to 6J The characteristics can be independent of Figures 2A to 4B Similarly, Figures 2A to 4B The distal part of Figures 5A to 6J Although some of the following actuation mechanisms may be described as having suitability for some of the above-described distal portions, it should be understood that these compatibilities are not limiting and various combinations of aspects of the distal portions and actuation mechanisms may be used. Where possible, corresponding reference numerals are used to represent corresponding structures.

[0035] Figure 5A and 5B A cross section of an example delivery device 300 is shown that can have any of the features of the delivery device 10. The delivery device 300 can have a handle 312 (e.g., an operating portion) and a sheath 314 (e.g., an insertion portion). The sheath 314 can include a catheter 315 or other suitable component. The lumen 320 can extend from a proximal portion of the catheter 315 to a distal end of the catheter 315.

[0036] The sheath 314 can also include a distal portion 316. The distal portion 316 can be a separate component from the catheter 315, or can be a single integral structure with the catheter 315. The distal portion 316 can be fixedly or removably attached to the distal end of the catheter 315. The distal portion 316 can be configured to contain a medicament 332. The distal portion 316 can have any of the properties of the distal portions 16, 116, 216 described above. Although the distal portion 316 is shown as having one chamber 330, it should be understood that multiple chambers can be utilized, such as shown, for example, Figures 3A to 4B The chamber 330 may terminate in the distal opening 318. The medicament 332 may be contained in the chamber 330. The piston 352 may slide within the chamber 330 and may have the same Figures 2A to 4BAny of the properties of any of the pistons described.

[0037] Figures 5A to 5B Examples may utilize a pneumatic actuation mechanism to slidably move the piston 352 within the chamber 330. It should be understood that Figures 5A to 5B The actuation mechanism can be Figures 6A to 6J used in conjunction with an actuation mechanism as discussed below. Figures 5A to 5B The actuation mechanism may also be used with a device 10 that includes any of the distal ends 16 , 116 , 216 .

[0038] The handle 312 may include a plunger 350. The plunger 350 may be operably connected to a piston 354 via a rod 356. Although the piston 354 is described as being disposed within the handle 312, it should be understood that the piston 354 may also be disposed within the sheath 314. The handle 312 may include a cavity 322 in which the piston 354 is slidably disposed. The piston 354 may form a seal with a surface of the cavity 322. The cavity 322 may have a larger cross-sectional diameter than the cavity 320, such as Figure 5A Alternatively, lumen 322 may have the same cross-sectional diameter as lumen 320 or a smaller cross-sectional diameter than lumen 320. The larger cross-sectional area of ​​lumen 322 may enable device 300 to have a shorter shaft 356.

[0039] Fluid 370 may be disposed within cavity 322, distal to piston 354 and proximal to piston 352. Pistons 352, 354 may include sealing features that retain fluid 370 between piston 352, 354. Figure 5A The delivery device 300 is shown in a first configuration, wherein the plunger 350 has not yet been depressed and the medicament 332 has not yet been dispensed through the opening 318 . Figure 5B The delivery device 300 is shown in a second configuration, wherein the plunger 350 has been at least partially depressed such that at least some of the medicament 332 has been dispensed through the opening 318. As the plunger 350 is depressed / advanced distally, the piston 354 can advance a corresponding (e.g., equal) amount. The plunger 350 can exert a force on the fluid 370 to advance the fluid 370 distally. The fluid 370 can exert a force on the piston 352, which in turn advances the medicament 332 through the opening 318, as described above with respect to Figures 1 to 4B as described.

[0040] Fluid 370 can be incompressible or compressible. For example, if fluid 370 is incompressible, when plunger 350 is depressed, medicament 332 can be dispensed from opening 318 immediately or almost immediately. If fluid 370 is compressible, there may be a delay between depression of plunger 350 and dispensing of medicament 332 from opening 318 because fluid 370 is compressed. Fluid 370 can include any suitable fluid. For example, fluid 370 can be biocompatible and can include saline.

[0041] Using fluid 370 as an actuation mechanism can allow sheath 314 to be flexible so that sheath 314 can pass through the working channel of an endoscope and through a tortuous body cavity of a subject. This flexibility of sheath 314 helps position medicament 332 in distal portion 316 so that medicament 332 is not wasted.

[0042] Figures 6A to 6J An alternative actuation mechanism is shown. Fig. 6A A delivery device 400 is shown, which can have any of the properties of delivery devices 10, 300. Delivery device 400 can have a handle 412 (e.g., an operating portion) and a sheath 414 (e.g., an insertion portion). Sheath 414 can include a catheter 415 or other suitable component. Lumen 420 can extend from a proximal portion of catheter 415 to a distal end of catheter 415 (see, e.g., Figures 6A to 6B ).

[0043] 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 contain a medicament. The distal portion 416 may have any of the properties of the distal portions 16, 116, 216, 316 described above. Figure 6C , 6E , 6F, 6H and 6J show exemplary distal portions 464, 466, 468, 470, 472 that can be used in place of distal portion 416. The features of distal portions 464, 466, 468, 470, 472 can be used in conjunction with any features of distal portions 16, 116, 216, 316, and corresponding structures are identified with the same reference numerals.

[0044] The handle 412 may include a plunger 450 that may be operably connected to a finger ring 462. The plunger 450 may have a component within the cavity 420. The handle 412 may also include a proximal thumb ring 464. Distally advancing the finger ring 462 on the body 465 of the handle 412 may cause the plunger 450 to be advanced distally. The features of the handle 412 may also be used with the handles 12, 312, as described above. Figures 6B to 6J , the plunger 450 can be operably connected (eg, mechanically coupled) to an actuation mechanism as described herein. Features of the handle 464, including the finger ring 462 and the thumb ring 464, can also be used with the device 10, 300, as described above.

[0045] Figure 6B Along the Fig. 6A The cross section along line AA shown in FIG. 4 shows a first exemplary actuation mechanism 481, and Figure 6C Shows that it can be Figure 6B An exemplary cross-section of the distal portion 464 used in conjunction with the actuation mechanism of FIG. Figure 6B As shown, the actuation mechanism may include a wire 482, which may be located in the cavity 420 of the sheath 414. The proximal portion of the wire 482 may be operably connected to the plunger 450 via, for example, crimping, welding, gluing or other fixing mechanisms. The wire 482 and the plunger 450 may alternatively be formed of a single integral material. The distal portion of the wire 482 may be operably connected (e.g., mechanically connected) to the piston 452, which may be slidably movable in the chamber 430. The wire 482 may be crimped, welded, glued or otherwise fixed to the piston 452. Alternatively, the wire 482 and the piston 452 may be formed of a single integral material. The 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. The wire 482 may have sufficient rigidity to transfer the force from the movement of the plunger 450 to the piston 452. However, the wire 482 may be sufficiently flexible so as not to inhibit, or possibly not substantially inhibit, the flexibility of the sheath 414. Although the term "wire" is used, it should be understood that the wire 482 may also comprise a structure made of a material such as plastic.

[0046] When the plunger 450 is advanced distally, the wire 482 can transmit force and / or motion to the piston 452, which causes the piston 452 to advance and can cause the dispensing of the medicament, as described above (e.g., with respect to Figures 2A to 2B of).

[0047] Fig.6D Along the Fig. 6A The cross section shown along line AA illustrates another exemplary actuation mechanism 483 . Fig. 6E and 6FExemplary distal portions 466, 168 are shown, which may be used with Fig.6D The actuating mechanism is used in combination with Fig.6D As shown, the actuation mechanism may include a tube 484 that may be located within the lumen 420 of the sheath 414. The proximal portion of the tube 484 may be operably coupled to the plunger 450 via, for example, crimping, welding, gluing or other fixing mechanisms. The tube 484 and the plunger 450 may alternatively be formed of a single unitary material. The tube 484 may have a central lumen or opening extending longitudinally therethrough.

[0048] like Fig. 6E As shown, the actuating mechanism 483 can be similar to Figures 2A to 2B The distal portion 16 of the distal portion 16 and can be used in combination with a distal portion 466 having any of the properties of the distal portion 16. The distal portion 466 can include a chamber 430, and the piston 452 can be slidably disposed in the chamber 430. The distal portion of the tube 484 can be operably connected (e.g., mechanically connected) to the piston 452. The tube 484 can be crimped, welded, glued or otherwise fixed to the piston 452. Alternatively, the tube 484 and the piston 452 can be formed of a single integral material. The tube 484 can be made of a flexible material, such as a plastic material, nitinol, a flexible polymer, a braided coil or other suitable material. The tube 484 can have sufficient rigidity to transmit the force from the movement of the plunger 450 to the piston 452. However, the tube 484 can have sufficient flexibility so as not to inhibit or may not substantially inhibit the flexibility of the sheath 414. Although tube 484 is shown as having a hollow central core, it should be understood that tube 484 may also have a solid cross-section, a lattice-like cross-section, etc.

[0049] When the plunger 450 is advanced distally, the tube 484 can transmit force from the plunger 450 to the piston 452, which causes the piston 452 to advance, which can cause the dispensing of the medicament, as described above (e.g., with respect to Figures 2A to 2B of).

[0050] like Fig. 6F As shown, the actuation mechanism 483 may alternatively be similar to Figures 4A to 4BThe distal portion 216 of the present invention can be used in combination with a distal portion 468 having any of its features. The distal portion 468 can include a first chamber 430a and a second chamber 430b. The first piston 452a can be slidably disposed in the first chamber 430a, and the second piston 452b can be slidably disposed in the second chamber 430b. The distal portion of the tube 484 can be operably connected (e.g., mechanically connected) to the first piston 452a and the second piston 452b. The tube 484 can be crimped, welded, glued or otherwise fixed to the first piston 452a and the second piston 452b. Alternatively, the tube 484 and the pistons 452a, 452b can be formed of a single integral material. The tube 482 can include a slot or other features (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.

[0051] When the plunger 450 is advanced distally, the tube 484 can transmit force from the plunger 450 to the two pistons 452a, 452b, which causes the pistons 452a, 452b to advance, which can cause the dispensing of the medicament, as described above (e.g., with respect to Figures 4A to 4B of).

[0052] Figure 6G Along the Fig. 6A Another exemplary actuation mechanism 486 is shown in cross section along line AA. Figure 6H Shows that it can be Figure 6G 4. An exemplary cross-section of a distal portion 470 used in conjunction with an actuation mechanism of the invention. The distal portion 470 may include a first chamber 430a and a second chamber 430b. The first piston 452a may be slidably disposed in the first chamber 430a, and the second piston 452b may be slidably disposed in the second chamber 430b.

[0053] like Figure 6G As shown, the actuation mechanism 486 may include wires 482a and 482b, which may be positioned within the lumen 420 of the sheath 414. Figure 6G Two wires 482a and 482b are shown, but any suitable number of wires may be used. The proximal portion of each of the wires 482a, 482b may be operably coupled to the plunger 450 via, for example, crimping, welding, gluing or other fixing mechanisms. The wires 482a, 482b and the plunger 450 may alternatively be formed of a single integral material. Alternatively, the wires 482a and 482b may be independently movable via, for example, a plurality of plungers (not shown).

[0054] The distal portion of wire 482a can be operably connected (e.g., mechanically connected) to first piston 452a. Wire 482a can be crimped, welded, glued or otherwise fixed to first piston 452a. Alternatively, wire 482a and first piston 452a can be formed of a single integral material. The distal portion of wire 482b can be operably connected (e.g., mechanically connected) to second piston 452b. Wire 482b can be crimped, welded, glued or otherwise fixed to second piston 452b. Alternatively, wire 482b and second piston 452b can be formed of a single integral material.

[0055] Wires 482a, 482b can have any of the properties of wire 482 described above. When plunger 450 is advanced distally, wire 482a can transmit force and / or motion to first piston 452a, which causes piston 452a to advance. Simultaneously (unless wires 482a and 482b are controlled separately), wire 482b can transmit force and / or motion of plunger 450 to second piston 452b. As described above (e.g., with respect to Figures 4A to 4B ), advancing the plunger 450 distally can result in dispensing of the medicament.

[0056] Fig.6I Along the Fig. 6A Another exemplary actuation mechanism 488 is shown in cross section along line AA as shown in FIG. Figure 6J An exemplary cross-section of a distal portion 472 that may be used in conjunction with an actuation mechanism 488 is shown. The distal portion 472 may have the Figures 3A to 3B Any of the properties of the distal portion 116 described above. The distal portion 472 can include a chamber 430 and a tube 432. The first piston 454 can be slidably disposed within the chamber 430, and the second piston 456 can be slidably disposed within the tube 432.

[0057] like Fig.6I As shown, the actuation mechanism 488 may include a wire 482, which may be located within the lumen 420 of the sheath 414 and may have the same configuration as described above. Figure 6B Any of the properties described above. The proximal portion of the wire 482 can be operably coupled to the plunger 450 via, for example, crimping, welding, gluing or other fixing mechanisms. The wire 482 and the plunger 450 can alternatively be formed of a single unitary material. The actuation mechanism 488 can also include a tube 484, which can also be located within the cavity 420 of the sheath 414 and can have the above-mentioned Figures 6D to 6FAny of the properties described. The proximal portion of the tube 484 can be operably coupled to the plunger 450 via, for example, crimping, welding, gluing or other fixing mechanisms. The tube 484 and the plunger 450 can alternatively be formed of a single integral material. Alternatively, the wire 482 and the tube 484 can be moved separately. The wire 482 can be located within the tube 484. For example, the wire 482 can be coaxial with the central longitudinal axis of the tube 484, or can be parallel to the central longitudinal axis of the tube 484.

[0058] The distal portion of the wire 482 can be operably connected (e.g., mechanically connected) to the first piston 456. The wire 482 can be crimped, welded, glued, or otherwise fixed to the first piston 456. Alternatively, the wire 482 and the first piston 456 can be formed of a single unitary material. The distal portion of the tube 484 can be operably connected (e.g., mechanically connected) to the second piston 454. The tube 484 can be crimped, welded, glued, or otherwise fixed to the second piston 454. Alternatively, the tube 484 and the piston 454 can be formed of a single unitary material.

[0059] When the plunger 450 is advanced, the wire 482 can transfer force from the plunger 450 to the piston 456, and the tube 484 can transfer force from the plunger 450 to the piston 454. Figures 3A to 3B ), advancing the plunger 450 distally can result in dispensing of the medicament.

[0060] 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 device comprising: handle; a sheath extending from the handle, wherein the sheath comprises: Chamber, including: a first subchamber configured to receive a first medicament; a second subchamber configured to receive a second medicament; a first piston received within the first subchamber; a second piston received within the second sub-chamber; and one or more actuating elements configured to transfer force from the handle to one or more of the first piston or the second piston; wherein, when the handle is in the first form, the first medicament is retained in the first sub-chamber, and the second medicament is retained in the second sub-chamber; Wherein, when the handle is in the second configuration, the first medicament is released from the distal opening of the first sub-chamber, and the second medicament is released from the distal opening of the second sub-chamber.

2. The medical device according to claim 1, wherein: In the second configuration, the first and second medicaments are released into a portion of the chamber that is distal to the respective distal ends of the first and second sub-chambers.

3. The medical device of claim 1 or 2, wherein the first and second sub-chambers are each defined by a tube within the chamber.

4. A medical device according to claim 1 or 2, wherein the sheath includes a partition extending longitudinally between the first sub-chamber and the second sub-chamber, wherein the first sub-chamber is defined by a portion of the inner wall of the chamber and the partition, and wherein the second sub-chamber is defined by another portion of the inner wall of the chamber and the partition.

5. The medical device of any one of the preceding claims, wherein the first sub-chamber is parallel to the second sub-chamber.

6. The medical device of any one of claims 1-4 and 7-15, wherein the first sub-chamber is transverse to the second sub-chamber.

7. The medical device according to any one of the preceding claims, wherein the respective distal openings of the first and second sub-chambers are proximal to the distal opening of the sheath.

8. A medical device according to any of the preceding claims, wherein the first subchamber and the second subchamber each include a membrane, wherein the membrane is configured to retain the first and second medicaments within the corresponding first and second subchambers when the handle is in the first form, and wherein the membrane is configured to rupture when the handle is in the second form to release the first and second medicaments from the corresponding first and second subchambers.

9. A medical device according to any of the preceding claims, wherein the distal opening of the sheath comprises a membrane configured to retain the first and second medicaments within the chamber when the handle is in a first form, wherein the membrane is configured to rupture to release the first and second medicaments from the chamber when the handle is in a second form.

10. The medical device of any of the preceding claims, wherein the one or more actuation elements comprise a tube operably connected to the first and second pistons, wherein the tube is configured to transfer force from the plunger to both the first and second pistons.

11. The medical device of claim 10, wherein the tube comprises one or more slots configured to receive one or more walls of the first and second sub-chambers.

12. The medical device of claim 10 or 11, wherein the tube is formed of Nitinol.

13. The medical device of any one of claims 1-9, wherein the one or more actuating elements comprise a first wire operably connected to the first piston and a second wire operably connected to the second piston, wherein the first wire and the second wire are each configured to transmit force from one or more plungers to one or more of the first piston or the second piston.

14. The medical device of claim 13, wherein movement of the first wire and movement of the second wire are mutually exclusive.

15. The medical device of any of the preceding claims, wherein the first and second sub-chambers each comprise a variable cross-section configured to achieve a mixing ratio of the first and second medicaments.

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