CN115814246B

CN115814246B - Delivery device and delivery method

Info

Publication number: CN115814246B
Application number: CN202211404849.6A
Authority: CN
Inventors: 李响; 韩玉光
Original assignee: Coyote Bioscience Yixing Co Ltd
Current assignee: Coyote Bioscience Yixing Co Ltd
Priority date: 2022-11-10
Filing date: 2022-11-10
Publication date: 2025-12-09
Anticipated expiration: 2042-11-10
Also published as: WO2024099322A1; CN115814246A

Abstract

The present disclosure provides a delivery device comprising an outer tube, a middle tube, an inner tube, and a push-pull rod that are sequentially sleeved. The delivery device is sequentially transitionable from a first state to a second state, a third state, and a fourth state by operation of a user, thereby sequentially effecting the mixing and delivery of the preloaded solid substance or drug and preloaded delivery liquid within the delivery device.

Description

Delivery device and delivery method

Technical Field

The present disclosure relates to a delivery device and a delivery method, and in particular, to a delivery device and a delivery method for delivering a mixture of a powdered drug and a liquid drug for easy user operation.

Background

Certain solid substances or drugs (e.g., probiotics) are not suitable for storage in the form of aqueous solutions or suspensions. These solid substances or drugs therefore need to be kept separate from the delivery solution prior to delivery to the user. Existing devices provide separate delivery devices (e.g., syringe-type injectors), vials containing solid matter or medication, and vials containing delivery solutions. In use, a user mixes a solid substance or drug with a delivery liquid to prepare an aqueous solution or suspension, loads the aqueous solution or suspension into a delivery device, and then operates the delivery device to infuse the aqueous solution or suspension into the body (e.g., into a blood vessel, nasal cavity, oral cavity, respiratory tract, vagina).

Disclosure of Invention

In one aspect, the present disclosure provides a delivery device. The delivery device may include an outer tube having a proximal end, a distal end and a lumen extending between the proximal and distal ends, 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 and distal ends, 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 being movable along an axis of the outer tube, an inner tube having a proximal end, a distal end and a lumen extending between the proximal and distal ends, 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, the at least a portion of the inner tube being disposed within the lumen of the middle tube and being movable along the axis of the middle tube, the at least one aperture being disposed along the distal end of the inner tube and the at least one lumen of the inner tube, a sealing member being disposed between the distal end of the inner tube and the at least one lumen of the inner tube and the distal end being movable along the axis of the lumen of the at least one lumen.

In another aspect, the present disclosure provides a method of delivering a substance. The method may include (a) providing a delivery device comprising (i) an outer tube having a proximal end, a distal end and a lumen extending between the proximal and distal ends, 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 and distal ends, 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 being 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 and distal ends, the proximal end of the inner tube, the distal end of the inner tube being open, the inner tube being provided with at least one aperture in communication with the lumen of the push-pull inner tube, the at least a portion of the inner tube being disposed in communication with the lumen of the push-pull tube, the at least one portion of the inner tube being disposed in communication with the lumen of the inner tube, the inner tube being provided with at least one aperture in communication with the lumen of the inner tube and the distal end of the inner tube, the inner tube being selectively movable along the axis of the inner tube with respect to the distal rod, the distal rod and the at least one of the inner tube being provided with at least one of the lumen of the tube and the sealing rod, 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 with respect to the inner tube, thereby transitioning the delivery device from the first state to a second state in which 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 aperture of the distal end of the middle tube, and (c) pushing the inner tube and the push-pull rod distally with respect to the middle tube, thereby transitioning the delivery device from the second state to a third state in which the first space and the second space in the second state are substantially maintained, and at least one of the second space in the second state is substantially reduced with respect to the second opening of the middle tube, thereby substantially maintaining the second space in the second state.

In another aspect, the present disclosure provides a kit comprising a delivery device as described in one aspect of the present disclosure, and optionally an indication directing a user to deliver a substance using the delivery device.

Other aspects and advantages of the present disclosure will become readily apparent to those skilled in the art from the following detailed description, wherein only illustrative embodiments of the present disclosure are shown and described. As will be realized, the present disclosure is capable of other and different embodiments and its several details are capable of modification in various obvious respects, all without departing from the present disclosure. Accordingly, the drawings and description are to be regarded as illustrative in nature, and not as restrictive.

Incorporation by reference

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.

Drawings

The novel features of the 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 disclosure are utilized, and the accompanying drawings of which:

Fig. 1 is a schematic diagram depicting an exemplary delivery device of the present disclosure.

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

Fig. 3 is an enlarged partial cross-sectional view depicting the inner tube mated with the delivery rod when an exemplary delivery device of the present disclosure is in a first state.

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

Fig. 5 is an enlarged partial cross-sectional view depicting the inner tube mated with the delivery rod when an exemplary delivery device of the present disclosure is in a second state.

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

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

Fig. 8 is a cross-sectional view depicting an exemplary delivery device of the present disclosure in a fourth state.

Fig. 9 is a flow chart depicting an exemplary method of delivering a substance using a delivery device of the present disclosure.

Detailed Description

While various embodiments of the present disclosure have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Many changes, modifications and substitutions will now occur to those skilled in the art without departing from the disclosure. It should be understood that various alternatives to the embodiments of the disclosure described herein may be employed.

Fig. 1 is a schematic diagram depicting an exemplary delivery device of the present disclosure. The exemplary delivery device 100 of the present disclosure may be preloaded with a solid substance or drug and a delivery liquid therein. The pre-filled solid substance or drug and the delivery liquid within the delivery device 100 are in separate chambers or spaces, respectively, to achieve physical separation prior to the user performing the delivery operation. In some examples, the solid substance or drug may be in the form of a powder, a granule, a microsphere, a tablet, or the like. The delivery liquid is used to dissolve a 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, nasal cavity, oral cavity, respiratory tract, vagina, and the like. In some examples, the solid substance or drug may include antibiotics, probiotics, care repair capsules, and the like. In some examples, the delivery liquid may include distilled water, physiological saline, lotions, nursing solutions, gels, and the like.

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

Fig. 2 is a cross-sectional view depicting an exemplary delivery device of the present disclosure in a first state. The first state may be a state in which the delivery device is not used after shipment. The outer tube 101 of the delivery device may have an elongated shape. The outer tube 101 may have a substantially circular, oval, square, rectangular, polygonal, etc. cross-sectional shape. In one example, the outer tube 101 may be substantially cylindrical in shape. The outer tube 101 may have a proximal end, a distal end, and a lumen extending between the proximal and distal ends. The proximal end of the outer tube (e.g., the end proximal to the operator's hand) may be substantially open. The distal end of the outer tube may be provided with at least one aperture 1012. The aperture 1012 passes through the wall of the distal end of the outer tube to communicate with the lumen of the outer tube. The solid substance or drug to be delivered may be delivered through the aperture to the target site of the user as a solution or mixture after mixing with the delivery liquid. In one example, the aperture 1012 may 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 may be provided with a plurality of apertures, which may be distributed over an end face of the distal end of the outer tube and/or over the outer tube surface near the distal end of the outer tube. In some examples, the delivery device may further include an outer tube cap 105 removably sleeved over the distal end of the outer tube. The outer tube cap may seal the aperture 1012 at the distal end of the outer tube. A protrusion may be provided in the outer tube cover that mates with the aperture 1012. When the outer tube cap is placed over the distal end of the outer tube, the protrusions of the outer tube cap are inserted into the apertures 1012 of the distal end of the outer tube to seal the apertures 1012.

The middle tube 102 of the delivery device may have an elongated shape. The cross-sectional shape of the middle tube 102 may be identical to the cross-sectional shape of the outer tube 101. In one example, the middle tube 102 may 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 may 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 may be disposed coaxially with the outer tube, and the middle tube may translate relative to the outer tube along an axis of the outer tube. The middle tube may have a proximal end, a distal end, and a lumen extending between the proximal and distal ends. The proximal end of the middle tube may be substantially open. The distal end of the middle tube may be provided with at least one aperture 1022. The aperture 1022 passes through the wall of the distal end of the middle tube to communicate with the lumen of the middle tube. The openings 1022 are used to deliver substances within the lumen of the middle tube out of the middle tube. In one example, the aperture 1022 may 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 may be fluid-tightly coupled to the inner wall of the outer tube such that the middle tube and the outer tube form a syringe-like piston and tube configuration. In one example, one or more sealing rings or posts may be sleeved at or near the distal end of the middle tube to form a fluid-tight seal between the outer wall of the middle tube and the inner wall of the outer tube.

The inner tube 103 of the delivery device may have an elongated shape. The cross-sectional shape of the inner tube 103 may be consistent with the cross-sectional shape of the middle tube 102. In one example, the inner tube 103 of the delivery device may 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 may be inserted into the lumen of the middle tube from the open proximal end of the middle tube 102. In some examples, the inner tube may be disposed coaxially with the middle tube, and the inner tube may translate relative to the middle tube along an axis of the middle tube. The inner tube may have a proximal end, a distal end, and a lumen extending between the proximal and distal ends. The proximal end of the inner tube may be substantially open. The distal end of the inner tube may be provided with at least one aperture. The aperture passes through the wall of the distal end of the inner tube 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 may 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 may be fluid-tightly coupled to the inner wall of the middle tube such that the inner tube and the middle tube form a syringe-like piston and tube configuration. For example, one or more sealing rings or sealing posts may be sleeved at or near the distal end of the inner tube to form a fluid-tight seal between the outer wall of the inner tube and the inner wall of the middle tube.

The push-pull rod 104 of the delivery device may 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, a push-pull rod may 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 may be disposed coaxially with the inner tube, and the push-pull rod may translate along an axis of the inner tube relative to the inner tube. The push-pull rod 104 may have a proximal end, a distal end, and a rod body extending between the proximal and distal ends. The proximal end of the push-pull rod may be provided with a grip for ease of user operation or ease of coupling to an external device. The distal end of the push-pull rod may be provided with a seal 1042. Depending on the position of the push-pull rod, the seal 1042 may 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.

In the first state of the delivery device shown in fig. 2, 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 predetermined chamber or space a within the lumen of the outer tube. Meanwhile, 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 predetermined chamber or space B within the lumen of the middle tube. The outer tube cap 105 may seal the aperture 1012 at the distal end of the outer tube. At this point, the seal 1042 at the distal end of the push-pull rod may seal the opening 1022 at the distal end of the middle tube, thereby physically and fluid-tightly isolating the chamber or space a from the chamber or space B. The seal 1042 may be made of an elastic material such as rubber, silicone, etc. In the first state of the delivery device shown in fig. 2, the seal 1042 can tightly seal the opening 1022 of the distal end of the middle tube by an interference fit. In other words, the seal 1042 can be removed from the opening 1022 in the distal end of the central tube only by applying a force to the push-pull rod that exceeds a predetermined threshold. This tight seal ensures that the seal 1042 at the distal end of the push-pull rod does not come out of the opening 1022 at the distal end of the tube during transport due to impact or the like. In one example, a solid substance or drug may be pre-stored in chamber or space a, while a delivery liquid may be pre-stored in chamber or space B. In another example, a delivery liquid may be pre-stored in chamber or space a, while a solid substance or drug may be pre-stored in chamber or space B. The predetermined volume of space a may be 1-100 milliliters. In some examples, the predetermined volume of space a may be 1 ml, 2 ml, 3 ml, 4 ml, 5ml, 6 ml, 7 ml, 8 ml, 9ml, 10 ml,11 ml, 12 ml, 13 ml, 14 ml, 15ml, 16 ml, 17 ml, 18 ml, 19 ml, 20 ml, 30 ml, 40ml, 50 ml, 60 ml, 70 ml, 80ml, 90 ml, or 100 ml. In one example, the predetermined volume of space a may be 1-8 milliliters. The predetermined volume of space B may be 1-100 milliliters. In some examples, the predetermined volume of space B may be 1 ml, 2 ml, 3 ml, 4 ml, 5ml, 6 ml, 7 ml, 8 ml, 9ml, 10 ml,11 ml, 12 ml, 13 ml, 14 ml, 15ml, 16 ml, 17 ml, 18 ml, 19 ml, 20 ml, 30 ml, 40ml, 50 ml, 60 ml, 70 ml, 80ml, 90 ml, or 100 ml. In one example, the predetermined volume of space B may be 2-6 milliliters. The predetermined volume of space a may be greater than or equal to the predetermined volume of space B. Or the predetermined volume of space B may be greater than or equal to the predetermined volume of space a.

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 remain fixed relative to the inner tube at a plurality of positions along the axis of the inner tube. Fig. 3 is an enlarged partial cross-sectional view depicting the inner tube mated with the delivery rod when an exemplary delivery device of the present disclosure is in a first state. As shown in the exemplary embodiment of fig. 3, the above-described position maintaining mechanism may include a receiving hole provided at a predetermined position of the outer wall of the inner tube (e.g., near the proximal end of the outer tube), and at least one protrusion 1046 provided on the push-pull rod (e.g., near the proximal end of the push-pull rod). In the example shown in fig. 3, a plurality of receiving holes 1032, 1034 are arranged along the axis of the inner tube. The protrusions on the push-pull rod are able to enter and be retained in the plurality of receiving holes of the inner tube, thereby securing the push-pull rod at a plurality of preset positions along the axis of the inner tube. In one example, the position-maintaining mechanism may further include at least one substantially axially extending resilient arm 1044 disposed at the proximal end of the push-pull rod. The extension direction of the resilient arm 1044 may deviate from the axial direction of the push-pull rod. At least one protrusion 1046 may be provided on the resilient arm 1044. Under the operation of a user, the elastic arm can deflect 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 a user presses the resilient arm in the axial direction of the push-pull rod, the protrusion 1046 on the resilient arm may be moved away from the receiving hole at the first position of the inner tube, so that the user may pull the push-pull rod proximally or distally in the axial direction 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 in a new relative position with respect to the inner tube, the user may release the resilient arm in a direction away from the axis of the push-pull rod to insert the protrusion 104 on the resilient arm into another receiving hole at the second position of the inner tube, thereby maintaining the push-pull rod in the new relative position with respect to the inner tube. In other examples, the position-maintaining mechanism may include an internal thread provided on an inner wall of at least the proximal end of the inner tube that spirals along the axis of the inner tube, and an external thread provided on an outer wall of at least the proximal end of the push-pull rod that spirals along the axis of the push-pull rod. The internal thread meshes with the external thread so that a user can move and fix the push-pull rod to a preset position relative to the inner tube by rotating the push-pull rod relative to the inner tube.

Fig. 4 is a cross-sectional view depicting an exemplary 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 of the delivery device (e.g., to the left as shown in fig. 4) relative to the inner tube 103. Upon transition from the first state to the second state of the delivery device, the outer tube cap 105 that is sleeved over the distal end of the outer tube may be removed, thereby maintaining the pressure within the cavity or space a of the outer tube and/or the cavity or space B of the middle tube in equilibrium with the outside to facilitate translation of the push-pull rod relative to the inner tube. As shown in the enlarged cross-sectional view in connection with fig. 5, in the first state shown in fig. 3, the user first presses the resilient arm 1044 in the axial direction of the push-pull rod such that the protrusion 1046 on the resilient arm leaves the receiving hole 1032 at the first position of the inner tube. The user in turn pulls the push-pull rod proximally with respect to the inner tube in the axial direction of the inner tube and releases the resilient arm at the second position of the inner tube in a direction away from the axial direction of the push-pull rod, thereby inserting the protrusion 104 on the resilient arm into the hole 1034 at the second position of the inner tube, thereby holding the push-pull rod at the second position of the inner tube. This achieves a transition of the delivery device from the first state to the second state.

During the transition from the first state to the second state of the delivery device, 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 is not displaced relative to the outer tube and the inner tube is not displaced relative to the middle tube. However, as shown in fig. 4, during the transition from the first state to the second state of the delivery device, the proximal translation of the push-pull rod 104 causes the seal 1042 at the distal end of the push-pull rod 104 to leave the aperture 1022 of the distal end of the middle tube, resulting in the seal 1042 of 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 and the chamber or space B within the lumen of the middle tube to communicate with each other through the aperture 1022. In one example, a solid substance or drug (e.g., a powdered probiotic or antibiotic) pre-stored in chamber or space a is thus in contact with, and at least partially dissolved in, a pre-stored delivery liquid in chamber or space B. In some examples, in the second state of the delivery device, the seal 1042 of the distal end of the push-pull rod can seal the aperture of the distal end of the inner tube.

Fig. 6 is a cross-sectional view depicting an 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 of the delivery device relative to the middle tube 102. Upon transition from the second state to the third state of the delivery device, the outer tube cap 105 that is positioned over the distal end of the outer tube may be removed to maintain the pressure in the chamber or space a within the lumen of the outer tube in equilibrium with the outside world to facilitate 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 may reseal the aperture 1022 of the distal end of the middle tube. The relative position of the push-pull rod and the inner tube may remain unchanged during the transition from the second state to the third state of the delivery device. This may 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 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 is not displaced relative to the outer tube. However, since the inner tube is displaced relative to the middle tube and the distal end of the inner tube is in close proximity or contact with the distal end of the middle tube in the third state, the space B within the lumen of the middle tube is substantially reduced to almost zero. As shown in the enlarged cross-sectional view of fig. 7, in the third state of the delivery device, as the distal end of the inner tube 103 approaches or contacts 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 within the primary space B within the lumen of the middle tube (e.g., which includes solid substances or drugs at least partially dissolved in the delivery liquid) 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 may shake the delivery device so that the solid substance or drug is further thoroughly mixed or dissolved in the delivery liquid. An outer tube cap 105 may be placed over the distal end of the outer tube to seal the aperture 1012 of the distal end of the outer tube prior to the user shaking the delivery device.

The travel of pushing both the inner tube 103 and the push-pull rod 104 distally relative to the middle tube 102 during the transition from the second state to the third state of the delivery device may be preset or limited. For example, the stroke of both the inner tube 103 and the push-pull rod 104 distally may be limited to just such that the distal end of the inner tube is immediately adjacent 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 reseals the aperture 1022 of the distal end of the middle tube. In one example, the middle tube may have a first stop (e.g., an inner collar or inner bump on an inner wall of the middle tube that protrudes toward the axis of the middle tube) and a second stop (e.g., an outer collar or outer bump on an outer wall of the inner tube that protrudes away from the axis of the inner tube). The travel of the inner tube in distal movement relative to the middle tube can be controlled by the blocking of the second stop by the first stop. In another example, the middle tube may have a first stop (e.g., a first step resulting from providing an expanded diameter portion at a preset location of the middle tube; the first step may be located near the proximal end of the middle tube) and the inner tube may have a second stop (e.g., a second step resulting from providing an expanded diameter portion at a preset location of the inner tube; the second step may be located near the proximal end of the inner tube). By blocking the second step by the first step, the travel of the inner tube distally relative to the middle tube can be controlled.

Fig. 8 is a cross-sectional view depicting an 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 three of the middle tube 102, the inner tube 103 and the push-pull rod 104 distally with respect to the outer tube 101. Before pushing the three of the middle tube 102, the inner tube 103 and the push-pull rod 104 distally relative to the outer tube 101, the outer tube cover 105, which is sleeved on the distal end of the outer tube, should be removed to expose the aperture 1012 of the distal end of the outer tube. The relative position of the push-pull rod and the inner tube may remain unchanged during the transition from the third state to the fourth state of the delivery device. This may be achieved by the position maintaining mechanism described herein for maintaining the relative position between the push-pull rod and the inner tube. The seal 1042 of the distal end of the push-pull rod 104 can retain the aperture 1022 of the distal end of the middle tube during transition from the third state to the fourth state of the delivery device. During the transition from the third state to the fourth state of the delivery device, the volume of the space a within the lumen of the outer tube in the third state is substantially reduced to almost zero, since the middle tube is displaced relative to the outer tube and in the fourth state the distal end of the middle tube is in close proximity or contact with the distal end of the outer tube. 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 remains sealed against the aperture 1022 of the distal end of the middle tube) such that the solution or mixture of solid substance or drug and delivery liquid within the original space a within the lumen of the outer tube is pressed through the aperture 1012 of the distal end of the outer tube into the predetermined body lumen of the user.

The travel of pushing the three of the middle tube 102, the inner tube 103 and the push-pull rod 104 distally during the transition from the third state to the fourth state of the delivery device may be preset or limited. For example, the travel of the three of the middle tube 102, the inner tube 103, and the push-pull rod 104 distally relative to the outer tube 101 may be limited to just so that the distal end of the middle tube 102 is in close proximity to or against the distal end of the outer tube 101. In one example, the middle tube may have a first stop, such as a protrusion provided at a preset location on the outer wall of the middle tube, positioned on the outer wall of the middle tube such that when it abuts the proximal end of the outer tube, the distal end of the middle tube 102 is just in close proximity to or abuts 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, the first stopper of the middle tube may be a stepped portion generated by providing an expanded diameter portion at a preset position of the middle tube. The step is positioned such that when it abuts the proximal end of the outer tube, the distal end of the middle tube 102 is just in close proximity to or abuts 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.

The present disclosure also provides a method for delivering a substance. As depicted in the flow chart of fig. 9, a method for delivering a substance may include processing 901 through processing 904. In process 901, a delivery device of the present disclosure may be provided that includes an outer tube, a middle tube, an inner tube, and a push-pull rod that are sleeved in sequence. The structure of the delivery device of the present disclosure is not described in detail herein. The delivery device may be in a first state. In this first state, there is a predetermined distance between the distal end of the outer tube and the distal end of the middle tube defining a first space, and a predetermined distance between the distal end of the middle tube and the distal end of the inner tube defining a second space, 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. In one example, the first space may be pre-stored with a solid substance or drug and the second space may be pre-stored with a delivery liquid.

In process 902, a push-pull rod is pulled proximally relative to an inner tube, thereby transitioning a delivery device from a first state to a second state. In the second state of the delivery device, said first space and said second space in the first state are substantially maintained and said 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. This results in the first space within the lumen of the outer tube communicating with the second space within the lumen of the middle tube through the at least one aperture of the distal end of the middle tube. Thus, the solid substance or drug (e.g., powdered probiotic) pre-stored in the first space is in contact with and at least partially dissolved in the delivery liquid pre-stored in the second space.

In process 903, both the inner tube and the push-pull rod are pushed distally relative to the middle tube, thereby transitioning the delivery device from the second state to the 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 may reseal the at least one aperture of the distal end of the middle tube. In the third state of the delivery device, as the distal end of the inner tube is near or in contact with the distal end of the middle tube 102, the substance within the primary second space within the lumen of the middle tube (e.g., which includes solid substances or drugs that are at least partially dissolved in the delivery liquid) is pressed through the aperture of the distal end of the middle tube into the first space within the lumen of the outer tube. At this point, the user may shake the delivery device so that the solid substance or drug is further thoroughly mixed or dissolved in the delivery liquid.

In process 904, the three of 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 the fourth state. In a 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 delivery liquid and solid substance or drug within the primary first space within the lumen of the outer tube to be extruded through the opening at the distal end of the outer tube into the intended body lumen of the user.

The present disclosure also provides a kit. The kit may include a delivery device of the present disclosure and, optionally, instructions directing a user to deliver a substance using the delivery device.

While preferred embodiments of the present disclosure have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the disclosure. It should be understood that various alternatives to the embodiments of the present disclosure described herein may be employed in practicing the present disclosure. It is intended that the following claims define the scope of the disclosure and that methods and structures within the scope of these claims and their equivalents be covered thereby.

Claims

1. A delivery device, comprising:

An outer tube having a proximal end, a distal end, and a cavity extending between the proximal end and the distal end, the proximal end of the outer tube being open, and the distal end of the outer tube having at least one opening communicating with the cavity of the outer tube.

A middle tube having a proximal end, a distal end, and a cavity 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 having at least one opening communicating with the cavity of the middle tube, and at least a portion of the middle tube being disposed within the cavity of the outer tube and movable relative to the outer tube along the axis of the outer tube;

An inner tube having a proximal end, a distal end, and a cavity extending between the proximal end and the distal end, the proximal end of the inner tube being open, and the distal end of the inner tube having at least one opening communicating with the cavity of the inner tube; at least a portion of the inner tube is disposed within the cavity of the middle tube and is movable relative to the middle tube along the axis of the middle tube; and

A push-pull rod has a proximal end, a distal end, and a rod body extending between the proximal and distal ends. The proximal end of the push-pull rod has a gripping portion, and the distal end of the push-pull rod is provided with a seal. The seal can selectively seal at least one of at least one opening at the distal end of the outer tube, at least one opening at the distal end of the middle tube, and at least one opening at the distal end of the inner tube. At least a portion of the push-pull rod is disposed in the cavity of the inner tube and is movable relative to the inner tube along the axis of the inner tube.

In the 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 at least one opening at the distal end of the middle tube.

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

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

4. The delivery device according to claim 3, wherein in the 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 according to claim 1, wherein the first space contains a powdered substance and the second space contains a liquid preparation.

6. The delivery device according to claim 1, wherein the position of the push-pull rod relative to the inner tube can be kept fixed at multiple locations along the axis of the inner tube.

7. The delivery device according to 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, the protrusion being able to enter the plurality of receiving holes to fix the push-pull rod at a plurality of preset positions along the axis of the inner tube.

8. The delivery device according to claim 7, wherein the proximal end of the push-pull rod is provided with an elastic arm, and the at least one protrusion is provided on the elastic arm along the axial direction of the elastic arm.

9. The delivery device according to claim 6, wherein the inner wall of at least the proximal end of the inner tube is provided with an internal 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 external thread extending along the axis of the push-pull rod, the internal thread engaging with the external thread to fix the push-pull rod at a plurality of predetermined positions along the axis of the inner tube.

10. A reagent kit comprising:

The delivery device as claimed in claim 1; and

Instructions to the user on how to use the delivery device to deliver substances.