CN115814246A - Delivery device and delivery method - Google Patents
Delivery device and delivery method Download PDFInfo
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- CN115814246A CN115814246A CN202211404849.6A CN202211404849A CN115814246A CN 115814246 A CN115814246 A CN 115814246A CN 202211404849 A CN202211404849 A CN 202211404849A CN 115814246 A CN115814246 A CN 115814246A
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- distal end
- tube
- push
- state
- pull rod
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- 238000002716 delivery method Methods 0.000 title description 4
- 239000000126 substance Substances 0.000 claims abstract description 36
- 230000007704 transition Effects 0.000 claims description 18
- 238000004891 communication Methods 0.000 claims description 12
- 238000000034 method Methods 0.000 claims description 12
- 239000012669 liquid formulation Substances 0.000 claims 1
- 239000003814 drug Substances 0.000 abstract description 27
- 229940079593 drug Drugs 0.000 abstract description 27
- 239000007787 solid Substances 0.000 abstract description 24
- 239000007788 liquid Substances 0.000 abstract description 20
- 239000000203 mixture Substances 0.000 abstract description 8
- 230000007246 mechanism Effects 0.000 description 7
- 238000007789 sealing Methods 0.000 description 7
- 239000000243 solution Substances 0.000 description 6
- 239000007864 aqueous solution Substances 0.000 description 5
- 239000007900 aqueous suspension Substances 0.000 description 5
- 230000008569 process Effects 0.000 description 5
- 239000006041 probiotic Substances 0.000 description 4
- 235000018291 probiotics Nutrition 0.000 description 4
- 210000004204 blood vessel Anatomy 0.000 description 2
- 238000010586 diagram Methods 0.000 description 2
- 210000000214 mouth Anatomy 0.000 description 2
- 210000003928 nasal cavity Anatomy 0.000 description 2
- 230000000529 probiotic effect Effects 0.000 description 2
- 210000002345 respiratory system Anatomy 0.000 description 2
- 238000006467 substitution reaction Methods 0.000 description 2
- 210000001215 vagina Anatomy 0.000 description 2
- 239000003242 anti bacterial agent Substances 0.000 description 1
- 229940088710 antibiotic agent Drugs 0.000 description 1
- 230000003115 biocidal effect Effects 0.000 description 1
- 230000000903 blocking effect Effects 0.000 description 1
- 239000002775 capsule Substances 0.000 description 1
- 230000008878 coupling Effects 0.000 description 1
- 238000010168 coupling process Methods 0.000 description 1
- 238000005859 coupling reaction Methods 0.000 description 1
- 238000006073 displacement reaction Methods 0.000 description 1
- 239000012153 distilled water Substances 0.000 description 1
- 239000013013 elastic material Substances 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 239000006210 lotion Substances 0.000 description 1
- 239000004005 microsphere Substances 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 239000002504 physiological saline solution Substances 0.000 description 1
- 229920001296 polysiloxane Polymers 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 230000008439 repair process Effects 0.000 description 1
- 230000000717 retained effect Effects 0.000 description 1
- 238000000926 separation method Methods 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Hematology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
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. The delivery device can be switched from the first state to the second state, the third state and the fourth state in sequence by operation of a user, so that mixing of a pre-filled solid substance or drug with a pre-filled delivery liquid and delivery of the mixture in the delivery device are achieved in sequence.
Description
Technical Field
The present disclosure relates to a delivery device and a delivery method, and more particularly, to a delivery device and a delivery method for delivering a mixture of a powdered drug and a liquid drug, which are convenient for a user to operate.
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 need to be kept separate from the delivery solution before delivery to the user. The existing devices provide separate delivery devices (e.g., a syringe), vials containing solid substances or drugs, and vials containing delivery solutions. In use, the user mixes the solid substance or drug with the delivery liquid to prepare an aqueous solution or suspension, loads the aqueous solution or suspension into the delivery device, and manipulates the delivery device to inject the aqueous solution or suspension into the body (e.g., into a blood vessel, nasal cavity, oral cavity, respiratory tract, vagina).
Disclosure of Invention
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. The delivery device can be switched from the first state to the second, third and fourth state in turn by operation of a user, thereby achieving in turn mixing of a pre-loaded solid substance or drug with a pre-loaded delivery liquid and delivery of the mixture within the delivery device.
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 cavity extending therebetween, 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 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 being provided with at least one aperture in communication with the cavity of the middle tube, at least a portion of the middle tube being disposed within the cavity of the outer tube and being 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 cavity 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 cavity of the inner tube, at least a portion of the inner tube being disposed within the cavity of the middle tube and being 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 rod body extending between the proximal end and the distal end, the proximal end of the push-pull rod having a grip, 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 in the cavity of the inner tube and movable relative to the inner tube along an axis of the inner tube.
In another aspect, the present disclosure provides a method of delivering a substance. The method can comprise the following steps: (a) Providing a delivery device comprising (i) 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, the distal end of the outer tube being provided with at least one aperture in communication with the cavity of the outer tube; (ii) 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 being provided with at least one aperture in communication with the cavity of the middle tube, at least a portion of the middle tube being disposed within the cavity 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 cavity 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 cavity of the inner tube, at least a portion of the inner tube being disposed within the cavity of the middle tube and being 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 rod body extending between the proximal end and the distal end, the proximal end of the push-pull rod having a grip, 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 in the cavity 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 a distal end of the middle tube, a second space is defined between the distal end of the middle tube and a 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 in the first state are substantially maintained and the seal at the distal end of the push-pull rod no longer seals the at least one aperture at 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 in the second state is substantially maintained and the second space in the second state is substantially reduced, and the seal of the distal end of the push-pull rod reseals 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 in the third state is substantially reduced.
In another aspect, the present disclosure provides a kit comprising a delivery device according to one aspect of the present disclosure, and optionally, instructions directing a user to use the delivery device to deliver a substance.
Other aspects and advantages of the present disclosure will become 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 disclosure is capable of other and different embodiments and its several details are capable of modifications in various obvious respects, all without departing from the disclosure. Accordingly, the drawings and description are to be regarded as illustrative in nature, and not as restrictive.
Is incorporated 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 believed characteristic 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 the 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, the middle tube, and the inner tube in cooperation with a delivery rod when the 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 the 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. Numerous variations, changes, and substitutions will 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. An exemplary delivery device 100 of the present disclosure may be pre-loaded with a solid substance or drug and a delivery liquid therein. Before the user performs the delivery operation, the solid substance or drug pre-loaded in the delivery device 100 and the delivery liquid are in different chambers or spaces, respectively, to achieve physical separation. In some examples, the solid substance or drug may be in the form of a powder, a particulate, a microsphere, a tablet, or the like. 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, nasal cavity, oral cavity, respiratory tract, vagina, and the like. In some examples, the solid substance or drug may include antibiotics, probiotics, care and repair capsules, and the like. In some examples, the delivery liquid may include distilled water, physiological saline, a lotion, a care solution, a gel, 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 disposed within the outer tube 101, an inner tube 103 at least partially disposed within the middle tube 102, and a push-pull rod 104 at least partially disposed 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 predefined within the delivery device, wherein a solid substance or drug and a delivery liquid, respectively, are pre-stored.
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, elliptical, 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 cavity extending between the proximal and distal ends. The proximal end of the outer tube (e.g., the end near 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 extends through the wall of the distal end of the outer tube to communicate with the lumen of the outer tube. A solution or mixture of the solid substance or drug to be delivered mixed with the delivery liquid can be delivered to the target site of the user through the opening. In one example, the apertures 1012 may be disposed at a distal end of the outer tube along an 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 the end surface of the distal end of the outer tube and/or over 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 disposed over the distal end of the outer tube. The outer tube cap may seal an aperture 1012 at the distal end of the outer tube. Protrusions may be provided in the outer tube cover that mate with the apertures 1012. When the outer tube cap is positioned over the distal end of the outer tube, the protrusion of the outer tube cap is inserted into the aperture 1012 at the distal end of the outer tube to seal the aperture 1012.
The middle tube 102 of the delivery device may have an elongated shape. The cross-sectional shape of the middle tube 102 may conform to the cross-sectional shape 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, middle tube 102 can be inserted into the lumen of the outer tube 101 from the open proximal end thereof. 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 can have 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 may be substantially open. The distal end of the middle tube may be provided with at least one opening 1022. The opening 1022 passes through the wall of the distal end of the middle tube to communicate with the lumen of the middle tube. The opening 1022 is used to deliver the substance within the lumen of the middle tube out of the middle tube. In one example, the apertures 1022 can be disposed at the distal end of the middle tube along the axis of the middle tube. An outer wall at or near the distal end of the middle tube may be fluidly coupled to the inner wall of the outer tube such that the middle tube and the outer tube form a syringe-like configuration of the piston and the barrel. In one example, one or more sealing rings or sealing posts may be sleeved at or near the distal end of the middle tube, forming a liquid-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 conform to the cross-sectional shape of the middle ring 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 cavity of the middle tube 102. For example, inner tube 103 can be inserted into the lumen of middle tube 102 from its proximal open end. 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 cavity 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 opening extends through the wall of the distal end of the inner tube to communicate with the lumen of the inner tube. The opening 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. An outer wall at or near the distal end of the inner tube may be liquid-tightly coupled to an inner wall of the middle tube, such that the inner tube and the middle tube form a syringe-like configuration of the piston and the tube. 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 cavity 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 relative to the inner tube along an axis of the inner tube. Push-pull rod 104 may have a proximal end, a distal end, and a rod body extending therebetween. The proximal end of the push-pull rod may be provided with a grip portion to facilitate user manipulation or coupling to an external device. The distal end of the push-pull rod may be provided with a seal 1042. The seal 1042 can selectively seal at least one of the opening at the distal end of the outer tube, the opening at the distal end of the middle tube, and the opening at the distal end of the inner tube, depending on the position of the push-pull rod.
In the first condition of the delivery device shown in fig. 2, the distal end of the outer tube 101 is a predetermined distance from the distal end of the middle tube 102, thereby defining a predetermined chamber or space a within the lumen of the outer tube. At the same time, the distal end of the middle tube 102 and the distal end of the inner tube 103 have a predetermined distance therebetween, thereby defining a predetermined chamber or space B within the cavity of the middle tube. The outer tube cap 105 may seal an 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 can seal the opening 1022 at the distal end of the middle tube, thereby physically and liquid-tightly isolating the chamber or space a and the chamber or space B. The sealing member 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 at the distal end of the middle tube by an interference fit. In other words, the seal 1042 can only be removed from the opening 1022 at the distal end of the middle tube if a force is applied 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 leave the opening 1022 at the distal end of the tube due to impact or the like during transport. In one example, chamber or space a may be pre-loaded with a solid substance or drug, while chamber or space B may be pre-loaded with a delivery fluid. In another example, chamber or space a may be pre-stored with a delivery liquid and chamber or space B may be pre-stored with a solid substance or drug. The predetermined volume of space a may be 1-100 ml. In some examples, the predetermined volume of space a may be 1 ml, 2 ml, 3 ml, 4 ml, 5 ml, 6 ml, 7 ml, 8 ml, 9 ml, 10 ml, 11 ml, 12 ml, 13 ml, 14 ml, 15 ml, 16 ml, 17 ml, 18 ml, 19 ml, 20 ml, 30 ml, 40 ml, 50 ml, 60 ml, 70 ml, 80 ml, 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 ml. In some examples, the predetermined volume of space B may be 1 ml, 2 ml, 3 ml, 4 ml, 5 ml, 6 ml, 7 ml, 8 ml, 9 ml, 10 ml, 11 ml, 12 ml, 13 ml, 14 ml, 15 ml, 16 ml, 17 ml, 18 ml, 19 ml, 20 ml, 30 ml, 40 ml, 50 ml, 60 ml, 70 ml, 80 ml, 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. Alternatively, 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 for maintaining the relative position between the push-pull rod 104 and the inner pipe 103 is provided. 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 an 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 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 projections on the push-pull rod are capable of entering and being retained in the plurality of receiving holes of the inner tube to secure the push-pull rod at a plurality of predetermined 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 a proximal end of the push-pull rod. The elastic arm 1044 may extend in a direction deviating from the axial direction of the push-pull rod. At least one boss 1046 may be provided on the resilient arm 1044. The elastic arm is deflectable toward or away from the axis of the push-pull rod in a direction perpendicular to the axis of the push-pull rod under operation of a user. 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 removed from the receiving hole at the first location of the inner tube, such 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 arms in a direction away from the axis of the push-pull rod to insert the protrusions 104 on the resilient arms into the other receiving holes 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 to spiral along an 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 to spiral along an axis of the push-pull rod. The internal threads engage the external threads such that a user can move and fix the push-pull rod to a predetermined 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 (e.g., to the left as shown in fig. 4) of the delivery device 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 fitted over the distal end of the outer tube may be removed, thereby maintaining the pressure in 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 in equilibrium with the environment to facilitate translation of the push-pull rod relative to the inner tube. As shown in the enlarged sectional view of fig. 5, in the first state shown in fig. 3, the user first presses the elastic arms 1044 toward the axial direction of the push-pull rod, so that the protrusions 1046 on the elastic arms leave the receiving holes 1032 at the first position of the inner tube. The user then pulls the push-pull rod proximally relative to the inner tube in the axial direction of the inner tube and releases the resilient arms in the axial direction away from the push-pull rod at the second position of the inner tube, thereby inserting the protrusions 104 on the resilient arms into the holes 1034 at the second position of the inner tube, thereby holding the push-pull rod at the second position of the inner tube. This enables the 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 volumes of the chamber or space a and the chamber or space B in the first state remain substantially unchanged, since the middle tube is not displaced with respect to the outer tube and the inner tube is not displaced with respect 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, translation of the push-pull rod 104 to the proximal side of the delivery device causes the seal 1042 at the distal end of the push-pull rod 104 to exit the aperture 1022 at the distal end of the middle tube, causing the seal 1042 at the distal end of the push-pull rod to no longer seal the aperture 1022 at the distal end of the middle tube, which causes the chamber or space a within the cavity of the outer tube and the chamber or space B within the cavity of the middle tube to communicate with each other through the aperture 1022. In one example, a pre-existing solid substance or drug (e.g., powdered probiotic or antibiotic) in chamber or space a is thus in contact with, and at least partially dissolved in, a pre-existing delivery liquid in chamber or space B. In some examples, the seal 1042 at the distal end of the push-pull rod can seal the aperture at the distal end of the inner tube in the second state of the delivery device.
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. In making the transition from the second state to the third state of the delivery device, the outer tube cap 105 fitted over the distal end of the outer tube may be removed, thereby maintaining the pressure in the chamber or space a within the lumen of the outer tube in equilibrium with the outside, 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 or contact with the distal end of the middle tube, and/or the seal 1042 at the distal end of the push-pull rod can reseal the opening 1022 at 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 cavity of the outer tube in the second state remains substantially unchanged, since the middle tube is not displaced with respect 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 closely adjacent to or in contact with the distal end of the middle tube in the third state, the space B within the cavity 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, since the distal end of the inner tube 103 is close 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 opening 1022 of the distal end of the middle tube, the substance (e.g., which includes a solid substance or drug at least partially dissolved in the delivery liquid) in the original space B within the cavity of the middle tube is squeezed through the opening 1022 of the distal end of the middle tube into the space a within the cavity of the outer tube. At this point, the user may shake the delivery device to further thoroughly mix or dissolve the solid substance or drug in the delivery liquid. Before the user shakes the delivery device, the outer tube cap 105 may be placed over the distal end of the outer tube to seal the aperture 1012 at the distal end of the outer tube.
During the transition from the second state to the third state of the delivery device, the stroke of pushing both the inner tube 103 and the push-pull rod 104 distally relative to the middle tube 102 may be preset or limited. For example, the distal travel of both the inner tube 103 and the push-pull rod 104 can be limited to just so far that the distal end of the inner tube is in close proximity or contact with the distal end of the middle tube and/or the seal 1042 at the distal end of the push-pull rod 104 reseals the aperture 1022 at the distal end of the middle tube. In one example, the middle tube can have a first stop (e.g., an inner collar or boss protruding on an inner wall of the middle tube toward an axis of the middle tube) and the inner tube can have a second stop (e.g., an outer boss collar or boss protruding on an outer wall of the inner tube away from the axis of the inner tube). The second limiting part is blocked by the first limiting part, so that the stroke of the inner tube moving towards the far side relative to the middle tube can be controlled. In another example, the middle tube can have a first stop (e.g., a first step resulting from providing an enlarged diameter at a predetermined location on 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 stop (e.g., a second step resulting from providing an enlarged diameter at a predetermined location on the inner tube; the second step can be located near the proximal end of the inner tube). The blocking of the second stepped part by the first stepped part can control the stroke of the inner tube moving far relative to the middle tube.
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 relative 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 cap 105 around the distal end of the outer tube should be removed to expose the aperture 1012 at 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 and the inner tube may remain unchanged. 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 third state to the fourth state of the delivery device, the seal 1042 at the distal end of the push-pull rod 104 can remain sealing the aperture 1022 at the distal end of the tube. During the transition from the third state to the fourth state of the delivery device, the volume of the space a within the cavity of the outer tube in the third state is substantially reduced to almost zero 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 with the distal end of the outer tube in the fourth state. 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 sealing the aperture 1022 of the distal end of the middle tube), so that the solid matter or the solution or mixture of the drug and the delivery liquid in the original space a within the cavity of the outer tube is pressed through the aperture 1012 of the distal end of the outer tube into the predetermined body cavity of the user.
During the transition from the third state to the fourth state of the delivery device, the stroke of pushing distally the middle tube 102, the inner tube 103, and the push-pull rod 104 may be preset or limited. For example, the distal travel of the three of the middle tube 102, the inner tube 103, and the push-pull rod 104 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 abuts the distal end of the outer tube 101. In one example, the middle tube may have a first stop, such as a protrusion disposed at a predetermined location on the outer wall of the middle tube, the protrusion being 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 a seal 1042 at the distal end of the push-pull rod 104 just seals the aperture 1012 at the distal end of the outer tube. In one example, as shown in the figure, the first limiting member of the middle pipe may be a step portion generated by providing an expanded diameter portion at a predetermined position of the middle pipe. The step is positioned such that when it abuts the proximal end of the outer tube, the distal end of middle tube 102 is just in close proximity to or abuts the distal end of outer tube 101, or seal 1042 at the distal end of push-pull rod 104 just seals aperture 1012 at the distal end of the outer tube.
The present disclosure also provides a method for delivering a substance. As illustrated in the flow chart of fig. 9, a method for delivering a substance may include processes 901-904. 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 sleeved in sequence. The structure of the delivery device of the present disclosure is not described herein. The delivery device may be in a first state. In the first state, there is a predetermined distance between the distal end of the outer tube and the distal end of the middle tube to define a first space, and a predetermined 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 the at least one opening 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, the push-pull rod is pulled proximally relative to the inner tube, thereby transitioning the delivery device from the first state to the second state. In a second state of the delivery device, the first space and the second space in the first state are substantially maintained, and the seal at the distal end of the push-pull rod no longer seals the at least one aperture at the distal end of the middle tube. This results in the first space within the cavity of the outer tube communicating with the second space within the cavity of the middle tube through the at least one aperture of the distal end of the middle tube. Thus, the pre-existing solid substance or drug (e.g. powdered probiotic) in the first space is in contact with and at least partially dissolved in the pre-existing delivery liquid 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 a third state. In a third state of the delivery device, the first space in the second state is substantially maintained, while the second space in the second state is substantially reduced to almost zero. And, the seal at the distal end of the push-pull rod may reseal the at least one opening at 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 (e.g., which comprises a solid substance or drug at least partially dissolved in the delivery liquid) within the original second space within the cavity of the middle tube is squeezed through the opening of the distal end of the middle tube into the first space within the cavity of the outer tube. At this point, the user may shake the delivery device to further thoroughly mix or dissolve the solid substance or drug in the delivery liquid.
In process 904, the middle tube, the inner tube, and the push-pull rod are all three pushed distally relative to the outer tube, thereby transitioning the delivery device from the third state to the 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 delivery liquid and solid substance or drug in the original first space within the lumen of the outer tube to be squeezed through the opening of the distal end of the outer tube into the intended body cavity of the user.
The present disclosure also provides a kit. The kit can include a delivery device of the present disclosure, and optionally, instructions directing a user to use the delivery device to deliver a substance.
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 disclosure described herein may be employed in practicing the 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 (12)
1. A delivery device, comprising:
an outer tube having a proximal end, a distal end, and a cavity extending therebetween, 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 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 being provided with at least one aperture in communication with the cavity of the middle tube, at least a portion of the middle tube being disposed within the cavity of the outer tube and being 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 cavity 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 cavity of the inner tube, at least a portion of the inner tube being disposed within the cavity of the middle tube and being 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 rod body extending between the proximal end and the distal end, the proximal end of the push-pull rod having a grip, 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 opening of the distal end of the outer tube, the at least one opening of the distal end of the middle tube, and the at least one opening of the distal end of the inner tube, at least a portion of the push-pull rod being disposed in the cavity of the inner tube and movable relative to the inner tube along an axis of the inner tube.
2. The delivery device of claim 1, wherein in a first state of the delivery device, a first space is defined between the distal end of the outer tube and a distal end of the middle tube, a second space is defined between the distal end of the middle tube and a 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.
3. The delivery device of claim 2, wherein in a second state of the delivery device, the first and second spaces in 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 achieved by pulling the push-pull rod proximally relative to the inner tube.
4. The delivery device of claim 3, wherein in a third state of the delivery device, the first space in the second state is maintained and 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 aperture 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.
5. The delivery device of claim 4, 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 distally pushing the middle tube, the inner tube, and the push-pull rod.
6. The delivery device of claim 2, wherein the first space is pre-filled with a powdered substance and the second space is pre-filled with a liquid formulation.
7. The delivery device of claim 1, wherein the position of the push-pull rod relative to the inner tube can remain fixed at a plurality of positions along the axis of the inner tube.
8. The delivery device of claim 7, wherein the proximal end of the inner tube is provided with a plurality of receiving holes aligned along the axis of the inner tube, and the proximal end of the push-pull rod is provided with at least one protrusion that is capable of entering the plurality of receiving holes to secure the push-pull rod at a plurality of predetermined positions along the axis of the inner tube.
9. The delivery device of claim, wherein the proximal end of the push-pull rod is provided with a resilient arm, the at least one protrusion being provided on the resilient arm in an axial direction of the resilient arm.
10. The delivery device of claim 7, wherein an 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 an 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 the external thread to secure the push-pull rod at a plurality of predetermined positions along the axis of the inner tube.
11. A method of delivering a substance, comprising:
(a) Providing a delivery device comprising (i) an outer tube having a proximal end, a distal end, and a cavity extending therebetween, 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 cavity of the outer tube; (ii) 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 being provided with at least one aperture in communication with the cavity of the middle tube, at least a portion of the middle tube being disposed within the cavity 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 cavity 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 cavity of the inner tube, at least a portion of the inner tube being disposed within the cavity of the middle tube and being 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 rod body extending between the proximal end and the distal end, the proximal end of the push-pull rod having a grip, 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 opening of the distal end of the middle tube and the at least one opening of the distal end of the inner tube, at least a portion of the push-pull rod being disposed in the cavity 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 a distal end of the middle tube, a second space is defined between the distal end of the middle tube and a 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 in the first state are substantially maintained and the seal at the distal end of the push-pull rod no longer seals the at least one aperture at 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 in the second state is substantially maintained and the second space in the second state is substantially reduced, and the seal of the distal end of the push-pull rod reseals 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 in the third state is substantially reduced.
12. A kit, comprising:
the delivery device of claim 1; and
optionally, instructions instructing the user to use the delivery device to deliver a substance.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202211404849.6A CN115814246A (en) | 2022-11-10 | 2022-11-10 | Delivery device and delivery method |
| PCT/CN2023/130264 WO2024099322A1 (en) | 2022-11-10 | 2023-11-07 | Delivery device and delivery method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202211404849.6A CN115814246A (en) | 2022-11-10 | 2022-11-10 | Delivery device and delivery method |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN115814246A true CN115814246A (en) | 2023-03-21 |
Family
ID=85527526
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202211404849.6A Pending CN115814246A (en) | 2022-11-10 | 2022-11-10 | Delivery device and delivery method |
Country Status (2)
| Country | Link |
|---|---|
| CN (1) | CN115814246A (en) |
| WO (1) | WO2024099322A1 (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2024099322A1 (en) * | 2022-11-10 | 2024-05-16 | 卡尤迪生物科技宜兴有限公司 | Delivery device and delivery method |
Family Cites Families (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3527216A (en) * | 1969-03-17 | 1970-09-08 | Brockway Glass Co Inc | Hypodermic syringe assembly |
| US4116240A (en) * | 1977-03-11 | 1978-09-26 | Guiney Aeneas C | Mixing syringe |
| US6488651B1 (en) * | 1997-10-20 | 2002-12-03 | Prc-Desoto International, Inc. | Multiple part manual dispensing syringe |
| US8092464B2 (en) * | 2005-04-30 | 2012-01-10 | Warsaw Orthopedic, Inc. | Syringe devices and methods useful for delivering osteogenic material |
| WO2006128915A1 (en) * | 2005-06-02 | 2006-12-07 | Schwoebel Eckhard | Multi-cylinder syringe |
| US8657481B2 (en) * | 2010-01-15 | 2014-02-25 | Spine Wave, Inc. | Systems and methods for mixing fluids |
| CN115814246A (en) * | 2022-11-10 | 2023-03-21 | 卡尤迪生物科技宜兴有限公司 | Delivery device and delivery method |
-
2022
- 2022-11-10 CN CN202211404849.6A patent/CN115814246A/en active Pending
-
2023
- 2023-11-07 WO PCT/CN2023/130264 patent/WO2024099322A1/en unknown
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2024099322A1 (en) * | 2022-11-10 | 2024-05-16 | 卡尤迪生物科技宜兴有限公司 | Delivery device and delivery method |
Also Published As
| Publication number | Publication date |
|---|---|
| WO2024099322A1 (en) | 2024-05-16 |
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