Delivery device and delivery method

Abstract

The present disclosure provides a delivery device comprising an outer tube, a middle tube, an inner tube and a push-pull rod which are sequentially sleeved. Through the operation of a user, the delivery device can be sequentially converted from a first state to a second state, a third state and a fourth state, thereby sequentially realizing the mixing of a solid substance or a drug and a delivery liquid which are preloaded in the delivery device and the delivery of the mixture.

Description

TECHNICAL FIELD

[0001] The present disclosure relates to a delivery device and a delivery method, in particular, a delivery device and a delivery method for facilitating user operation to deliver a mixture of a powdered medicament and a liquid medicament. BACKGROUND

[0002] Certain solid substances or medicaments (e.g., probiotics) are not suitable for storage in the form of an aqueous solution or suspension. Therefore, these solid substances or medicaments need to be stored separately from a delivery solution before delivery to a user. Existing devices provide separate delivery devices (e.g., a syringe), a vial containing the solid substance or medicament, and a vial containing the delivery solution. In use, the user mixes the solid substance or medicament with the delivery solution to prepare an aqueous solution or suspension, loads the aqueous solution or suspension into the delivery device, and then operates the delivery device to inject the aqueous solution or suspension into the body (e.g., into a blood vessel, the nasal cavity, the oral cavity, the respiratory tract, the vagina). SUMMARY

[0003] The present disclosure provides a delivery device including an outer tube, a middle tube, an inner tube, and a push-pull rod, which are sequentially sleeved. Through user operation, the delivery device can be sequentially converted from a first state to a second state, a third state, and a fourth state, thereby sequentially achieving mixing of a preloaded solid substance or medicament and a preloaded delivery liquid in the delivery device and delivery of the mixture.

[0004] In one aspect, the present disclosure provides a delivery device. The delivery device can include an outer tube having a proximal end, a distal end, and a lumen extending between the proximal end and the distal end, the proximal end of the outer tube being open, the distal end of the outer tube being provided with at least one aperture in communication with the lumen of the outer tube; a middle tube having a proximal end, a distal end, and a lumen extending between the proximal end and the distal end, the proximal end of the middle tube being open, the distal end of the middle tube being provided with at least one aperture in communication with the lumen of the middle tube, at least a portion of the middle tube being disposed within the lumen of the outer tube and movable relative to the outer tube along an axis of the outer tube; an inner tube having a proximal end, a distal end, and a lumen extending between the proximal end and the distal end, the proximal end of the inner tube being open, the distal end of the inner tube being provided with at least one aperture in communication with the lumen of the inner tube, at least a portion of the inner tube being disposed within the lumen of the middle tube and movable relative to the middle tube along an axis of the middle tube; and a push-pull rod having a proximal end, a distal end, and a shaft extending between the proximal end and the distal end, the proximal end of the push-pull rod having a handle, the distal end of the push-pull rod being provided with a seal that can selectively seal at least one of the at least one aperture of the distal end of the outer tube, the at least one aperture of the distal end of the middle tube, and the at least one aperture of the distal end of the inner tube, at least a portion of the push-pull rod being disposed within the lumen of the inner tube and movable relative to the inner tube along an axis of the inner tube.

[0005] In another aspect, the present disclosure provides a method of delivering a substance. The method can comprise: (a) providing a delivery device comprising (i) an outer tube having a proximal end, a distal end, and a lumen extending between the proximal end and the distal end, the proximal end of the outer tube being open, the distal end of the outer tube being provided with at least one aperture in communication with the lumen of the outer tube; (ii) a middle tube having a proximal end, a distal end, and a lumen extending between the proximal end and the distal end, the proximal end of the middle tube being open, the distal end of the middle tube being provided with at least one aperture in communication with the lumen of the middle tube, at least a portion of the middle tube being disposed within the lumen of the outer tube and movable relative to the outer tube along an axis of the outer tube; (iii) an inner tube having a proximal end, a distal end, and a lumen extending between the proximal end and the distal end, the proximal end of the inner tube being open, the distal end of the inner tube being provided with at least one aperture in communication with the lumen of the inner tube, at least a portion of the inner tube being disposed within the lumen of the middle tube and movable relative to the middle tube along an axis of the middle tube; and (iv) a push-pull rod having a proximal end, a distal end, and a shaft extending between the proximal end and the distal end, the proximal end of the push-pull rod having a handle, the distal end of the push-pull rod being provided with a seal that can selectively seal at least one of the at least one aperture of the distal end of the middle tube and the at least one aperture of the distal end of the inner tube, at least a portion of the push-pull rod being disposed within the lumen of the inner tube and movable relative to the inner tube along an axis of the inner tube; wherein the delivery device is in a first state in which a first space is defined between the distal end of the outer tube and the distal end of the middle tube, a second space is defined between the distal end of the middle tube and the distal end of the inner tube, and the seal of the distal end of the push-pull rod seals the at least one aperture of the distal end of the middle tube; (b) pulling the push-pull rod proximally relative to the inner tube, thereby transitioning the delivery device from the first state to a second state, wherein in the second state of the delivery device, the first space and the second space of the first state are substantially maintained, and the seal of the distal end of the push-pull rod no longer seals the at least one aperture of the distal end of the middle tube; (c) pushing the inner tube and the push-pull rod distally relative to the middle tube, thereby transitioning the delivery device from the second state to a third state, wherein in the third state of the delivery device, the first space of the second state is substantially maintained, the second space of the second state is substantially reduced, and the seal of the distal end of the push-pull rod re-seals the at least one aperture of the distal end of the middle tube; and (d) pushing the middle tube, the inner tube, and the push-pull rod distally relative to the outer tube, thereby transitioning the delivery device from the third state to a fourth state, wherein in the fourth state of the delivery device, the first space of the third state is substantially reduced.

[0006] In another aspect, the present disclosure provides a kit comprising a delivery device as described in one aspect of the present disclosure, and optionally, instructions for a user to deliver a substance using the delivery device.

[0007] Other aspects and advantages of the present disclosure will become apparent to those skilled in the art from the following detailed description, in which illustrative embodiments of the present disclosure are shown and described. It will be recognized not to limit the disclosure to the specific embodiments disclosed and described, as the present disclosure includes other and different embodiments. Accordingly, the description is illustrative, but not restrictive.

[0008] Incorporated by reference

[0009] All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. BRIEF DESCRIPTION OF DRAWINGS

[0010] The novel features of the present disclosure are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present disclosure will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the present disclosure are utilized, and the accompanying drawings of which:

[0011] Figure 1 is a schematic view depicting an exemplary delivery device of the present disclosure.

[0012] Figure 2 is a cross-sectional view depicting an exemplary delivery device of the present disclosure in a first state.

[0013] Figure 3 is a partial enlarged cross-sectional view depicting an exemplary delivery device of the present disclosure in the first state with the inner tube mated to the delivery rod.

[0014] Figure 4 is a cross-sectional view depicting an exemplary delivery device of the present disclosure in a second state.

[0015] Figure 5 is a partial enlarged cross-sectional view depicting an exemplary delivery device of the present disclosure in the second state with the inner tube mated to the delivery rod.

[0016] Figure 6 is a cross-sectional view depicting an exemplary delivery device of the present disclosure in a third state.

[0017] Figure 7 is a partial enlarged cross-sectional view depicting an exemplary delivery device of the present disclosure in the third state with the outer tube, middle tube, inner tube, and delivery rod mated.

[0018] Figure 8 is a cross-sectional view depicting an example delivery device of the present disclosure in a fourth state.

[0019] Figure 9 is a flow chart depicting an example method of delivering a substance using a delivery device of the present disclosure. DETAILED DESCRIPTION

[0020] While various embodiments of the present disclosure have been shown and described herein, it will be apparent to those skilled in the art that many changes, modifications, and substitutions can be made thereto without departing from the disclosure. It is to be understood that various alternatives to the embodiments of the disclosure described herein can be employed.

[0021] Figure 1 is a schematic view depicting an example delivery device of the present disclosure. An example delivery device 100 of the present disclosure can be pre-loaded with a solid substance or drug and a delivery liquid therein. The solid substance or drug and the delivery liquid pre-loaded in the delivery device 100 are physically separated in different chambers or spaces, respectively, before a user performs a delivery operation. In some examples, the solid substance or drug can be in a form of a powder, a particle, a microsphere, a tablet, etc. The delivery liquid is used to dissolve the solid substance or drug to obtain an aqueous solution or suspension of the substance or drug for delivery to a target delivery site of a user, such as a blood vessel, a nasal cavity, an oral cavity, a respiratory tract, a vaginal canal, etc. In some examples, the solid substance or drug can include an antibiotic, a probiotic, a capsule for care and repair, etc. In some examples, the delivery liquid can include distilled water, saline, a lotion, a care liquid, a gel, etc.

[0022] An example delivery device 100 of the present disclosure can include an outer tube 101, a middle tube 102 at least partially sleeved in the outer tube 101, an inner tube 103 at least partially sleeved in the middle tube 102, and a push-pull rod 104 at least partially sleeved in the inner tube 103. In an unused state, one or more chambers or spaces are pre-defined in the delivery device. In one example, the delivery device is pre-defined with a chamber or space A and a chamber or space B physically separated therefrom (to be described in detail below), in which a solid substance or drug and a delivery liquid are pre-stored, respectively.

[0023] Figure 2is a cross-sectional view depicting an exemplary delivery device of the present disclosure in a first state. The first state can be a state in which the delivery device is out of the factory and has not been used. The outer tube 101 of the delivery device can have an elongated shape. The outer tube 101 can have a substantially circular, elliptical, square, rectangular, polygonal, etc. cross-sectional shape. In one example, the outer tube 101 can be substantially cylindrical in shape. The outer tube 101 can have a proximal end, a distal end, and a lumen extending between the proximal end and the distal end. The proximal end of the outer tube (e.g., the end closer to the hand of the operator) can be substantially open. The distal end of the outer tube can be provided with at least one aperture 1012. The aperture 1012 penetrates the tube wall of the distal end of the outer tube so as to communicate with the lumen of the outer tube. The solution or mixture of the solid substance or drug to be delivered and the delivery liquid can be delivered to the target site of the user through the aperture. In one example, the aperture 1012 can be disposed at the distal end of the outer tube along the axis of the outer tube. In another example, the distal end of the outer tube can be provided with a plurality of apertures, which can be distributed on the end face of the distal end of the outer tube and / or on the surface of the outer tube near the distal end of the outer tube. In some examples, the delivery device can further include an outer tube cap 105 removably sleeved on the distal end of the outer tube. The outer tube cap can seal the aperture 1012 of the distal end of the outer tube. The inner wall of the outer tube cap can be provided with a protrusion matching the aperture 1012. When the outer tube cap is sleeved on the distal end of the outer tube, the protrusion of the outer tube cap is inserted into the aperture 1012 of the distal end of the outer tube so as to seal the aperture 1012.

[0024] The middle tube 102 of the delivery device can have an elongated shape. The cross-sectional shape of the middle tube 102 can be consistent with that of the outer tube 101. In one example, the middle tube 102 can be substantially cylindrical in shape. At least a portion of the middle tube 102 of the delivery device is disposed within the lumen of the outer tube 101. For example, the middle tube 102 can be inserted into the lumen of the outer tube from the open proximal end of the outer tube 101. In some examples, the middle tube can be disposed coaxially with the outer tube, and the middle tube can be translated relative to the outer tube along the axis of the outer tube. The middle tube can have a proximal end, a distal end, and a lumen extending between the proximal end and the distal end. The proximal end of the middle tube can be substantially open. The distal end of the middle tube can be provided with at least one aperture 1022. The aperture 1022 penetrates the tube wall of the distal end of the middle tube so as to communicate with the lumen of the middle tube. The aperture 1022 is used to deliver the substance in the lumen of the middle tube to outside the middle tube. In one example, the aperture 1022 can be disposed at the distal end of the middle tube along the axis of the middle tube. The outer wall at or near the distal end of the middle tube can be fluid-tightly coupled to the inner wall of the outer tube, so that the middle tube and the outer tube form a structure similar to the piston and tube body of a syringe. In one example, one or more sealing rings or sealing posts can be sleeved at or near the distal end of the middle tube, so as to form a fluid-tight seal between the outer wall of the middle tube and the inner wall of the outer tube.

[0025] The inner tube 103 of the delivery device can have an elongated shape. The cross-sectional shape of the inner tube 103 can be consistent with that of the middle tube 102. In one example, the inner tube 103 of the delivery device can be substantially cylindrical in shape. At least a portion of the inner tube 103 of the delivery device is disposed within the lumen of the middle tube 102. For example, the inner tube 103 can be inserted into the lumen of the middle tube 102 from the open proximal end of the middle tube. In some examples, the inner tube can be disposed coaxially with the middle tube, and the inner tube can be translated relative to the middle tube along the axis of the middle tube. The inner tube can have a proximal end, a distal end, and a lumen extending between the proximal end and the distal end. The proximal end of the inner tube can be substantially open. The distal end of the inner tube can be provided with at least one aperture. The aperture penetrates the tube wall of the distal end of the inner tube so as to communicate with the lumen of the inner tube. The aperture is sized to allow the push-pull rod 104 to pass axially therethrough. In one example, the aperture can be disposed at the distal end of the inner tube along the axis of the inner tube. The outer wall at or near the distal end of the inner tube can be fluid-tightly coupled to the inner wall of the middle tube, such that the inner tube and the middle tube form a configuration similar to that of a piston and a barrel of a syringe. For example, one or more sealing rings or sealing posts can be fitted at or near the distal end of the inner tube, so as to form a fluid-tight seal between the outer wall of the inner tube and the inner wall of the middle tube.

[0026] The push-pull rod 104 of the delivery device can have an elongated shape. At least a portion of the push-pull rod 104 is disposed within the lumen of the inner tube 103. For example, the push-pull rod can be inserted into the lumen of the inner tube from the open proximal end of the inner tube. In some examples, the push-pull rod can be disposed coaxially with the inner tube, and the push-pull rod can be translated relative to the inner tube along the axis of the inner tube. The push-pull rod 104 can have a proximal end, a distal end, and a rod body extending between the proximal end and the distal end. The proximal end of the push-pull rod can be provided with a handle to facilitate user operation or to facilitate coupling to an external device. The distal end of the push-pull rod can be provided with a seal 1042. Depending on the position of the push-pull rod, the seal 1042 can selectively seal at least one of the aperture of the distal end of the outer tube, the aperture of the distal end of the middle tube, and the aperture of the distal end of the inner tube.

[0027] In Figure 2 In the first state of the delivery device as shown, there is a predetermined distance between the distal end of the outer tube 101 and the distal end of the middle tube 102, thereby defining a pre-set chamber or space A within the lumen of the outer tube. At the same time, there is a predetermined distance between the distal end of the middle tube 102 and the distal end of the inner tube 103, thereby defining a pre-set chamber or space B within the lumen of the middle tube. The outer tube cap 105 can seal the aperture 1012 of the distal end of the outer tube. At this time, the seal 1042 of the distal end of the push-pull rod can seal the aperture 1022 of the distal end of the middle tube, thereby physically and fluid-tightly isolating the chamber or space A and the chamber or space B. The seal 1042 can be made of an elastic material, such as rubber, silicone, etc. In the first state of the delivery device, the push-pull rod 104 can be in a first position, in which the distal end of the push-pull rod is disposed within the lumen of the inner tube 103, and the seal 1042 of the distal end of the push-pull rod is disposed within the aperture 1022 of the distal end of the middle tube 102. Figure 2In the first state of the delivery device shown, the seal 1042 can tightly seal the opening 1022 of the distal end of the middle tube by interference fit. In other words, only when a force exceeding a predetermined threshold is applied to the push-pull rod, the seal 1042 can be removed from the opening 1022 of the distal end of the middle tube. Such tight seal ensures that the seal 1042 of the distal end of the push-pull rod does not come off the opening 1022 of the distal end of the tube due to bumping or the like during transportation. In one example, the chamber or space A can be pre-stored with a solid substance or a drug, while the chamber or space B can be pre-stored with a delivery liquid. In another example, the chamber or space A can be pre-stored with a delivery liquid, while the chamber or space B can be pre-stored with a solid substance or a drug. The predetermined volume of the space A can be 1-100 milliliters. In some examples, the predetermined volume of the space A can be 1 milliliter, 2 milliliters, 3 milliliters, 4 milliliters, 5 milliliters, 6 milliliters, 7 milliliters, 8 milliliters, 9 milliliters, 10 milliliters, 11 milliliters, 12 milliliters, 13 milliliters, 14 milliliters, 15 milliliters, 16 milliliters, 17 milliliters, 18 milliliters, 19 milliliters, 20 milliliters, 30 milliliters, 40 milliliters, 50 milliliters, 60 milliliters, 70 milliliters, 80 milliliters, 90 milliliters, or 100 milliliters. In one example, the predetermined volume of the space A can be 1-8 milliliters. The predetermined volume of the space B can be 1-100 milliliters. In some examples, the predetermined volume of the space B can be 1 milliliter, 2 milliliters, 3 milliliters, 4 milliliters, 5 milliliters, 6 milliliters, 7 milliliters, 8 milliliters, 9 milliliters, 10 milliliters, 11 milliliters, 12 milliliters, 13 milliliters, 14 milliliters, 15 milliliters, 16 milliliters, 17 milliliters, 18 milliliters, 19 milliliters, 20 milliliters, 30 milliliters, 40 milliliters, 50 milliliters, 60 milliliters, 70 milliliters, 80 milliliters, 90 milliliters, or 100 milliliters. In one example, the predetermined volume of the space B can be 2-6 milliliters. The predetermined volume of the space A can be greater than or equal to the predetermined volume of the space B. Alternatively, the predetermined volume of the space B can be greater than or equal to the predetermined volume of the space A.

[0028] In some examples, a position maintaining mechanism is provided for maintaining the relative position between the push-pull rod 104 and the inner tube 103. The position maintaining mechanism is configured to enable the push-pull rod to be held fixed relative to the inner tube at a plurality of positions along the axis of the inner tube. Figure 3 is a partial enlarged sectional view depicting the inner tube cooperating with the delivery rod when the exemplary delivery device of the present disclosure is in the first state. As shown in Figure 3 As shown in the exemplary embodiments of Figure 3In the illustrated example, a plurality of receiving holes 1032, 1034 are arranged along the axis of the inner tube. The protrusions on the push-pull rod can enter and be retained in the plurality of receiving holes of the inner tube, thereby fixing the push-pull rod at a plurality of pre-determined positions along the axis of the inner tube. In one example, the position retaining mechanism can further include at least one substantially axially extending resilient arm 1044 provided at the proximal end of the push-pull rod. The direction of extension of the resilient arm 1044 can be offset from the axis of the push-pull rod. At least one protrusion 1046 can be provided on the resilient arm 1044. Upon user manipulation, the resilient arm can be deflected towards or away from the axis of the push-pull rod in a direction perpendicular to the axis of the push-pull rod. For example, when the user presses the resilient arm towards the axis of the push-pull rod, the protrusion 1046 on the resilient arm can exit a receiving hole at a first position of the inner tube, such that the user can pull the push-pull rod proximally or distally along the axis of the push-pull rod, thereby changing the position of the push-pull rod relative to the inner tube. When the push-pull rod is at a new relative position relative to the inner tube, the user can release the resilient arm away from the axis of the push-pull rod to insert the protrusion 104 on the resilient arm into another receiving hole at a second position of the inner tube, thereby retaining the push-pull rod at the new relative position relative to the inner tube. In other examples, the above-mentioned position retaining mechanism can include an internal thread on the inner wall of at least the proximal end of the inner tube spiraling along the axis of the inner tube, and an external thread on the outer wall of at least the proximal end of the push-pull rod spiraling along the axis of the push-pull rod. The internal thread engages with the external thread, such that the user can move the push-pull rod to and fix it at a pre-determined position relative to the inner tube by rotating the push-pull rod relative to the inner tube.

[0029] Figure 4 is a cross-sectional view depicting an example delivery device of the present disclosure in a second state. The transition from the first state to the second state of the delivery device is achieved by pulling the push-pull rod 104 proximally (e.g., to the left as illustrated) relative to the inner tube 103. In making the transition from the first state to the second state of the delivery device, the outer tube cap 105, which is fitted over the distal end of the outer tube, can be removed to equalize the pressure within the chamber or space A within the lumen of the outer tube and / or the chamber or space B within the lumen of the middle tube with the ambient, facilitating the translation of the push-pull rod relative to the inner tube. Figure 4 is a cross-sectional view depicting an example delivery device of the present disclosure in a second state. The transition from the first state to the second state of the delivery device is achieved by pulling the push-pull rod 104 proximally (e.g., to the left as illustrated) relative to the inner tube 103. In making the transition from the first state to the second state of the delivery device, the outer tube cap 105, which is fitted over the distal end of the outer tube, can be removed to equalize the pressure within the chamber or space A within the lumen of the outer tube and / or the chamber or space B within the lumen of the middle tube with the ambient, facilitating the translation of the push-pull rod relative to the inner tube. Figure 5 is a cross-sectional view depicting an example delivery device of the present disclosure in a second state. The transition from the first state to the second state of the delivery device is achieved by pulling the push-pull rod 104 proximally (e.g., to the left as illustrated) relative to the inner tube 103. In making the transition from the first state to the second state of the delivery device, the outer tube cap 105, which is fitted over the distal end of the outer tube, can be removed to equalize the pressure within the chamber or space A within the lumen of the outer tube and / or the chamber or space B within the lumen of the middle tube with the ambient, facilitating the translation of the push-pull rod relative to the inner tube. Figure 3In the first state shown, the user first presses the resilient arm 1044 in the axial direction of the push-pull rod, so that the protrusion 1046 on the resilient arm exits the receiving hole 1032 at the first position of the inner tube. The user then pulls the push-pull rod in the axial direction of the inner tube relative to the inner tube and releases the resilient arm in the axial direction away from the push-pull rod at the second position of the inner tube, so that the protrusion 104 on the resilient arm is inserted into the hole 1034 at the second position of the inner tube, thereby retaining the push-pull rod at the second position of the inner tube. This achieves the transition of the delivery device from the first state to the second state.

[0030] During the transition of the delivery device from the first state to the second state, the volume of the chamber or space A and the chamber or space B in the first state remains substantially unchanged, since the middle tube does not displace relative to the outer tube, and the inner tube does not displace relative to the middle tube. However, as shown, Figure 4 During the transition of the delivery device from the first state to the second state, the translation of the push-pull rod 104 proximally of the delivery device causes the seal 1042 at the distal end of the push-pull rod 104 to exit the aperture 1022 of the distal end of the middle tube, resulting in the seal 1042 at the distal end of the push-pull rod no longer sealing the aperture 1022 of the distal end of the middle tube, which causes the chamber or space A within the lumen of the outer tube to communicate with the chamber or space B within the lumen of the middle tube through the aperture 1022. In one example, the solid substance or drug (e.g., powdered probiotic or antibiotic) pre-stored within the chamber or space A comes into contact with, and at least partially dissolves in, the delivery liquid pre-stored within the chamber or space B. In some examples, the seal 1042 at the distal end of the push-pull rod can seal the aperture of the distal end of the inner tube in the second state of the delivery device.

[0031] Figure 6is a cross-sectional view depicting the exemplary delivery device of the present disclosure in a third state. The transition from the second state to the third state of the delivery device is achieved by pushing both the inner tube 103 and the push-pull rod 104 distally relative to the middle tube 102. In making the transition from the second state to the third state of the delivery device, the outer tube cap 105 that is fitted over the distal end of the outer tube can be removed to equalize the pressure in the chamber or space A within the lumen of the outer tube with the ambient, to facilitate the translation of both the inner tube 103 and the push-pull rod 104 relative to the middle tube. In the third state, the distal end of the inner tube is in close proximity to or in contact with the distal end of the middle tube, and / or the seal 1042 of the distal end of the push-pull rod can reseal the aperture 1022 of the distal end of the middle tube. The relative positions of the push-pull rod and the inner tube can remain unchanged during the transition from the second state to the third state of the delivery device. This can be achieved by the position maintaining mechanism described herein for maintaining the relative positions between the push-pull rod and the inner tube. During the transition from the second state to the third state of the delivery device, the volume of the chamber or space A within the lumen of the outer tube in the second state remains substantially unchanged since the middle tube does not displace relative to the outer tube. However, the volume of the space B within the lumen of the middle tube is substantially reduced to almost zero since the inner tube displaces relative to the middle tube and the distal end of the inner tube is in close proximity to or in contact with the distal end of the middle tube in the third state. As shown in the enlarged cross-sectional view of Figure 7 the third state of the delivery device, since the distal end of the inner tube 103 is in close proximity to or in contact with the distal end of the middle tube 102, and / or the seal 1042 of the distal end of the push-pull rod 104 reseals the aperture 1022 of the distal end of the middle tube, the substance (e.g., which includes a solid substance or drug that is at least partially dissolved in the delivery liquid) within the original space B within the lumen of the middle tube is forced through the aperture 1022 of the distal end of the middle tube into the space A within the lumen of the outer tube. At this point, the user can shake the delivery device to further fully mix or dissolve the solid substance or drug in the delivery liquid. Prior to the user shaking the delivery device, the outer tube cap 105 can be fitted over the distal end of the outer tube to seal the aperture 1012 of the distal end of the outer tube.

[0032] During the transition from the second state to the third state of the delivery device, the travel of both the inner tube 103 and the push-pull rod 104 relative to the middle tube 102 can be preset or limited. For example, the travel of both the inner tube 103 and the push-pull rod 104 distally can be limited to just enough to bring the distal end of the inner tube in close proximity to or in contact with the distal end of the middle tube and / or the seal 1042 of the distal end of the push-pull rod 104 to reseal the aperture 1022 of the distal end of the middle tube. In one example, the middle tube can have a first stopper (e.g., an inner protruding ring or block on the inner wall of the middle tube towards the axis of the middle tube) while the inner tube can have a second stopper (e.g., an outer protruding ring or block on the outer wall of the inner tube away from the axis of the inner tube). By the blocking of the first stopper to the second stopper, the travel of the inner tube distally relative to the middle tube can be controlled. In another example, the middle tube can have a first stopper (e.g., a first step created by a diameter expansion at a preset location of the middle tube; the first step can be located near the proximal end of the middle tube) while the inner tube can have a second stopper (e.g., a second step created by a diameter expansion at a preset location of the inner tube; the second step can be located near the proximal end of the inner tube). By the blocking of the first step to the second step, the travel of the inner tube distally relative to the middle tube can be controlled.

[0033] Figure 8is a cross-sectional view depicting the exemplary delivery device of the present disclosure in a fourth state. The transition from the third state to the fourth state of the delivery device is achieved by subsequently pushing the middle tube 102, the inner tube 103 and the push-pull rod 104 all distally relative to the outer tube 101. Prior to pushing the middle tube 102, the inner tube 103 and the push-pull rod 104 all distally relative to the outer tube 101, the outer tube cap 105 that is sleeved over the distal end of the outer tube should be removed to expose the aperture 1012 of the distal end of the outer tube. During the transition from the third state to the fourth state of the delivery device, the relative position of the push-pull rod to the inner tube can remain unchanged. This can be achieved by the position maintaining mechanism described herein for maintaining the relative position between the push-pull rod and the inner tube. During the transition from the third state to the fourth state of the delivery device, the seal 1042 of the distal end of the push-pull rod 104 can maintain the aperture 1022 of the distal end of the middle tube sealed. During the transition from the third state to the fourth state of the delivery device, due to the displacement of the middle tube relative to the outer tube and the close proximity or contact of the distal end of the middle tube to the distal end of the outer tube in the fourth state, the volume of the space A within the lumen of the outer tube in the third state is substantially reduced to almost zero. In other words, in the fourth state of the delivery device, the distal end of the middle tube 102 is close to or in contact with the distal end of the outer tube 101 (wherein the seal 1042 of the distal end of the push-pull rod 104 maintains the aperture 1022 of the distal end of the middle tube sealed), such that the solid substance or drug within the original space A within the lumen of the outer tube and the solution or mixture of the delivery liquid are squeezed through the aperture 1012 of the distal end of the outer tube into the predetermined body cavity of the user.

[0034] During the transition from the third state to the fourth state of the delivery device, the travel of pushing the middle tube 102, the inner tube 103 and the push-pull rod 104 all distally can be preset or limited. For example, the travel of moving the middle tube 102, the inner tube 103 and the push-pull rod 104 all distally relative to the outer tube 101 can be limited to just such that the distal end of the middle tube 102 is in close proximity to or abuts against the distal end of the outer tube 101. In one example, the middle tube can have a first limit member, for example a protrusion provided at a preset position on the outer wall of the middle tube, which is positioned on the outer wall of the middle tube such that when it abuts against the proximal end of the outer tube, the distal end of the middle tube 102 is just in close proximity to or abuts against the distal end of the outer tube 101, or the seal 1042 of the distal end of the push-pull rod 104 just seals the aperture 1012 of the distal end of the outer tube. In one example, as shown in the figure, the first limit member of the middle tube can be a step portion created by providing an enlarged diameter portion at a preset position of the middle tube. The step portion is positioned such that when it abuts against the proximal end of the outer tube, the distal end of the middle tube 102 is just in close proximity to or abuts against the distal end of the outer tube 101, or the seal 1042 of the distal end of the push-pull rod 104 just seals the aperture 1012 of the distal end of the outer tube.

[0035] The present disclosure also provides a method for delivering a substance. As Figure 9 The method for delivering a substance can include processes 901-904, as described in the flowchart. In process 901, a delivery device of the present disclosure can be provided, which includes an outer tube, a middle tube, an inner tube, and a push-pull rod, which are sequentially sleeved. The structure of the delivery device of the present disclosure is not repeated here. The delivery device can be in a first state. In the first state, there is a preset distance between the distal end of the outer tube and the distal end of the middle tube to define a first space, and there is a preset distance between the distal end of the middle tube and the distal end of the inner tube to define a second space, and the seal of the distal end of the push-pull rod seals at least one opening of the distal end of the middle tube. In one example, the first space can pre-store a solid substance or a drug, and the second space can pre-store a delivery liquid.

[0036] In process 902, the push-pull rod is pulled proximally relative to the inner tube, thereby transforming the delivery device from the first state to a second state. In the second state of the delivery device, the first space and the second space in the first state are substantially maintained, and the seal of the distal end of the push-pull rod no longer seals the at least one opening of the distal end of the middle tube. This causes the first space in the cavity of the outer tube to communicate with the second space in the cavity of the middle tube through the at least one opening of the distal end of the middle tube. Therefore, the pre-stored solid substance or drug (e.g., powdered probiotics) in the first space contacts and at least partially dissolves in the delivery liquid pre-stored in the second space.

[0037] In process 903, the inner tube and the push-pull rod are both pushed distally relative to the middle tube, thereby transforming the delivery device from the second state to a third state. In the third state of the delivery device, the first space in the second state is substantially maintained, and the second space in the second state is substantially reduced to almost zero. And the seal of the distal end of the push-pull rod can reseal the at least one opening of the distal end of the middle tube. In the third state of the delivery device, because the distal end of the inner tube is close to or in contact with the distal end of the middle tube 102, the substance in the original second space in the cavity of the middle tube (e.g., which includes the solid substance or drug at least partially dissolved in the delivery liquid) is extruded through the opening of the distal end of the middle tube into the first space in the cavity of the outer tube. At this time, the user can shake the delivery device to further fully mix or dissolve the solid substance or drug in the delivery liquid.

[0038] In process 904, the middle tube, the inner tube, and the push-pull rod are pushed distally relative to the outer tube, thereby transitioning the delivery device from the third state to a fourth state. In the fourth state of the delivery device, the first space in the third state is substantially reduced to almost zero. This causes the solution or mixture of the delivery liquid and the solid substance or drug within the original first space inside the lumen of the outer tube to be squeezed through the aperture of the distal end of the outer tube, thereby into the predetermined body cavity of the user.

[0039] The present disclosure also provides a kit. The kit can include the delivery device of the present disclosure, and optionally, instructions for a user to deliver a substance using the delivery device.

[0040] While preferred embodiments of the present disclosure have been shown and described herein, it will be apparent to those skilled in the art that many changes, modifications, and substitutions can be made thereto without departing from the disclosure. It is to be understood that various alternatives to the embodiments of the disclosure described herein can be employed in practicing the present disclosure. It is intended to cover, by the appended claims, all such changes, modifications, and substitutions as fall within the scope of the present disclosure.

Claims

1. A delivery device comprising: an outer tube having a proximal end, a distal end, and a lumen extending between the proximal end and the distal end, the proximal end of the outer tube being open, the distal end of the outer tube being provided with at least one aperture in communication with the lumen of the outer tube; a middle tube having a proximal end, a distal end, and a lumen extending between the proximal end and the distal end, the proximal end of the middle tube being open, the distal end of the middle tube being provided with at least one aperture in communication with the lumen of the middle tube, at least a portion of the middle tube being disposed within the lumen of the outer tube and movable relative to the outer tube along an axis of the outer tube; an inner tube having a proximal end, a distal end, and a lumen extending between the proximal end and the distal end, the proximal end of the inner tube being open, the distal end of the inner tube being provided with at least one aperture in communication with the lumen of the inner tube, at least a portion of the inner tube being disposed within the lumen of the middle tube and movable relative to the middle tube along an axis of the middle tube; and a push-pull rod having a proximal end, a distal end, and a shaft extending between the proximal end and the distal end, the proximal end of the push-pull rod having a handle, the distal end of the push-pull rod being provided with a seal that can selectively seal at least one of the at least one aperture of the distal end of the outer tube, the at least one aperture of the distal end of the middle tube, and the at least one aperture of the distal end of the inner tube, at least a portion of the push-pull rod being disposed within the lumen of the inner tube and movable relative to the inner tube along an axis of the inner tube, wherein, in a first state of the delivery device, a first space is defined between the distal end of the outer tube and the distal end of the middle tube, a second space is defined between the distal end of the middle tube and the distal end of the inner tube, and the seal of the distal end of the push-pull rod seals the at least one aperture of the distal end of the middle tube.

2. The delivery device of claim 1, wherein, in a second state of the delivery device, the first space and the second space of the first state are maintained, and the seal of the distal end of the push-pull rod no longer seals the at least one aperture of the distal end of the middle tube, and wherein the transition from the first state to the second state is effected by pulling the push-pull rod proximally relative to the inner tube.

3. The delivery device of claim 2, wherein, in a third state of the delivery device, the first space of the second state is maintained, while the second space of the second state is at least reduced, and the seal of the distal end of the push-pull rod seals the at least one aperture of the distal end of the middle tube, and wherein the transition from the second state to the third state is effected by pushing the inner tube and the push-pull rod distally. ​ 4. The delivery device of claim 3, wherein in a fourth state of the delivery device, the first space in the third state is at least reduced, and wherein the transition from the third state to the fourth state is achieved by pushing the middle tube, the inner tube and the push-pull rod distally.

5. The delivery device of claim 1, wherein the first space is pre-provisioned with a powdered substance and the second space is pre-provisioned with a liquid formulation.

6. The delivery device of claim 1, wherein the position of the push-pull rod relative to the inner tube is capable of being held fixed at a plurality of positions along the axis of the inner tube.

7. The delivery device of claim 6, wherein the proximal end of the inner tube is provided with a plurality of receiving holes arranged along the axis of the inner tube, and the proximal end of the push-pull rod is provided with at least one protrusion capable of entering the plurality of receiving holes to thereby fix the push-pull rod at a plurality of pre-determined positions along the axis of the inner tube.

8. The delivery device of claim 7, wherein the proximal end of the push-pull rod is provided with a resilient arm, and the at least one protrusion is arranged on the resilient arm along the axis of the resilient arm.

9. The delivery device of claim 6, wherein the inner wall of at least the proximal end of the inner tube is provided with an inner thread extending along the axis of the inner tube, and the outer wall of at least the proximal end of the push-pull rod is provided with an outer thread extending along the axis of the push-pull rod, and the inner thread is engaged with the outer thread to thereby fix the push-pull rod at a plurality of pre-determined positions along the axis of the inner tube.

10. A kit comprising: a delivery device as claimed in claim 1; and instructions for a user to use the delivery device to deliver a substance.

11. A method of using a delivery device as claimed in claim 1 to deliver a substance, the method comprising: providing the delivery device as claimed in claim 1; providing a substance to be delivered; inserting the substance into the first space of the delivery device; inserting the delivery device into a body cavity of a patient; activating the delivery device to deliver the substance to the body cavity of the patient.

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