Injector suitable for temperature-sensitive gel and using method thereof

Abstract

The invention relates to the technical field of medical auxiliary instruments. An injector suitable for temperature-sensitive gel comprises an injector base body, the injector base body comprises an injection cylinder and an injection push rod, the end of the injection cylinder is provided with a connecting nozzle used for being detachably connected with a needle head, the injector further comprises a detachable cold accumulation piece, the detachable cold accumulation piece comprises an outer-layer cold accumulation agent cavity and a heat insulation layer, and the outer-layer cold accumulation agent cavity and the heat insulation layer are arranged inside and outside. A containing cavity used for containing an injector base body is formed in the center of the outer-layer cold accumulation cavity, and the two ends of the containing cavity in the axial direction are both open. The top of the storage cavity is rotationally clamped with the syringe; the bottom of the containing cavity is provided with a limiting extending part used for abutting against the connecting nozzle. The outer wall of the outer-layer coolant cavity is covered with a heat insulation layer. The structure of the injector is optimized, the injector base body and the detachable cold accumulation piece are independent of each other and can be disassembled or combined according to requirements, and the cold accumulation agent in the outer-layer cold accumulation agent cavity can be repeatedly used.

Description

Technical Field

[0001] The invention relates to the field of medical auxiliary instruments, in particular to a syringe for injecting temperature-sensitive gel. Background Art

[0002] Thermosensitive gel (also called thermosensitive hydrogel) is a special biomaterial that can respond to changes in ambient temperature and produce phase changes. Commonly used thermosensitive gels can be divided into two categories: artificial synthesis and natural formation. Artificial synthesis materials include poly N-isopropylacrylamide, poloxamer, polyethylene glycol-polyester; natural formation materials include chitosan, cellulose, etc. The gel has a microscopic network structure. When the temperature is at a low temperature (<4 ℃), the gel network structure shrinks, presenting a free-flowing liquid with low viscosity suitable for injection; when the temperature rises to a certain level, the gel swells and produces a phase change to a semi-solid state. The change in gel morphology is because the hydrophilic groups and hydrophobic groups that exist in the gel material at the same time change when the ambient temperature changes, and the interaction between these groups and other molecules changes, affecting the network structure in the gel, and then causing a phase change. Under normal circumstances, its phase change temperature is 37 ℃. Taking advantage of its high fluidity and low viscosity in low-temperature environments, functional gels can be placed into lesions in the body by injection. A solution-gel phase transition occurs in the body temperature environment, and it quickly condenses into an in-situ gel solid, thereby exerting a biochemical pharmacological effect. This property makes thermosensitive gels have broad application prospects in the fields of drug delivery, tissue engineering, and biomedical engineering.

[0003] In animal experiments and clinical applications related to thermosensitive hydrogels, how to ensure that the gel is in a uniform flow state before injection is a technical problem that needs to be solved. An injection device that can provide and maintain a relatively low temperature environment is an important device. Since the gel has a certain viscosity, it takes a certain amount of time to complete the injection operation, and the gelation time of thermosensitive gel is relatively short. In actual operation, factors such as high ambient temperature, the temperature of the operator's hand-held area, and long injection time can easily cause the local gel to solidify prematurely in the syringe, causing the needle to be blocked, resulting in the failure of the injection to be completed smoothly.

[0004] At present, the injection method for temperature-sensitive hydrogels is often to quickly complete the injection operation in a low temperature environment, and the needle and syringe must be pre-cooled in an ice bath in advance. The injector is required to use the pre-cooled syringe to quickly absorb the liquid gel placed in the ice bath and complete the injection operation in a relatively short time.

[0005] There are many problems with the above method. First, in order to ensure that the cavity is surrounded by a low-temperature environment, ordinary syringes generally use an ice bath to maintain low temperature. However, this method has a short insulation time and high requirements for environmental conditions. When the syringe is taken out of the ice bath and the suction and injection operations are started, the gel in the cavity is easily affected by the ambient temperature and the temperature of the injector's fingers. The rapid injection operation is difficult and has a low success rate. It is not convenient for delicate operations and requires high technical skills from the operator. In addition, it also has high requirements for storage environmental conditions and is not convenient for short-distance transportation and temporary storage. Summary of the invention

[0006] In view of the problems existing in the prior art, the present invention provides a syringe suitable for temperature-sensitive gel and a method of using the same, which has solved at least one of the above-mentioned technical problems.

[0007] The technical solution of the present invention is: a syringe suitable for temperature-sensitive gel, comprising a syringe base, the syringe base comprising a syringe barrel and an injection push rod, the end of the syringe barrel is a connection nozzle for detachably connecting a needle, characterized in that it also comprises a detachable cold storage component, the detachable cold storage component comprises an outer cold storage cavity and a heat insulation layer arranged inside and outside, a storage cavity for accommodating the syringe base is arranged in the center of the outer cold storage cavity, and both ends of the storage cavity in the axial direction are open;

[0008] The top of the receiving chamber is rotatably engaged with the injection cylinder;

[0009] The bottom of the storage cavity is provided with a limiting extension portion for abutting against the connecting nozzle, and the inner wall of the storage cavity, the limiting extension portion and the connecting nozzle form an annular space for a detachable connecting needle;

[0010] The outer layer refrigerant cavity is provided with a storage space for storing refrigerant and is annularly arranged around the outer periphery of the storage cavity. The top of the outer layer refrigerant cavity is provided with an injection port connected to the storage space, and the injection port is detachably connected with a sealing plug;

[0011] The outer wall of the outer layer refrigerant cavity is covered with the heat insulation layer, and a temperature insulation pad for hand gripping is detachably connected to the area of ​​the heat insulation layer adjacent to the connection nozzle;

[0012] The detachable cold storage component also includes a thermal insulation cover, which is detachably connected to the outer wall of the heat insulation layer, and a rubber cushion for resisting the connecting mouth is fixed inside the thermal insulation cover.

[0013] The present invention optimizes the structure of the syringe, and the syringe base and the detachable cold storage component are independent of each other. The two can be disassembled or combined according to needs, and the cold storage agent in the outer cold storage agent cavity can be reused and replaced when necessary, which is economical and convenient and avoids unnecessary waste.

[0014] Further preferably, the injection push rod comprises a push rod portion and a piston portion which are arranged up and down, and the push rod portion is provided with scale lines along the length direction.

[0015] Further preferably, the thermal insulation cover is rotatably engaged with the thermal insulation layer;

[0016] The outer wall of the heat insulation layer is provided with two arc-shaped protrusions arranged opposite to each other;

[0017] The inner wall of the heat insulation cover is provided with a rotation clamping groove for rotationally clamping the arc-shaped protrusion.

[0018] Further preferably, the thermal insulation layer includes a thermal insulation sponge, aluminum foil and a plastic matrix arranged in sequence from the inside to the outside, and the plastic matrix is ​​fixedly connected to the outer wall of the outer heat storage agent cavity to form an annular cavity for accommodating the thermal insulation sponge, and the annular cavity is arranged around the periphery of the outer coolant cavity.

[0019] Further preferably, the thermal insulation sponge is a composite sponge foamed from a polyethylene film and ethylene-vinyl acetate copolymer.

[0020] Further preferably, the thermal insulation cover comprises a plastic substrate with a hollow cavity, and thermal insulation sponge and aluminum foil are arranged in the hollow cavity from the inside to the outside, and the hollow cavity is arranged around the periphery of the connecting nozzle.

[0021] Further preferably, the coolant is a mixed solution of 25 mL of water and sodium polyacrylate.

[0022] Further preferably, the axial thickness of the upper and lower ends of the thermal insulation pad is greater than the axial thickness of the middle portion of the thermal insulation pad;

[0023] The thickness of the thermal insulation pad is 5 mm at the thickest part and 2 mm at the thinnest part.

[0024] It can effectively prevent the influence of the temperature of the injector's fingertips on the thermosensitive gel in the cavity during injection.

[0025] Further preferably, the thermosensitive gel is a liquid gel cross-linked with chitosan and sodium β-glycerophosphate.

[0026] Further preferably, the needle head comprises a plastic connection port and a metal needle which are connected in sequence, and the inner wall of the plastic connection port is connected with a frosted coating.

[0027] It is convenient to connect tightly with the connection nozzle to prevent liquid leakage.

[0028] Further preferably, the inner diameter of the injection syringe is 13 mm, the outer diameter is 14 mm, the axial length of the injection syringe is 64 mm, the total volume is 2.5 mL, and the material of the injection syringe is polypropylene or polycarbonate;

[0029] The wall thickness of the outer layer refrigerant cavity is 1 mm, and the axial length of the outer layer refrigerant cavity is 70 mm;

[0030] The diameter of the outer inner wall of the annular space is 14 mm.

[0031] The method for using a syringe suitable for a temperature-sensitive gel is characterized by comprising the following steps:

[0032] Step 1: filling or replacing the coolant through the injection port at the top of the outer coolant cavity;

[0033] The detachable cold storage component is placed in a -20°C refrigerator for 4 hours to solidify the cold storage agent, and then taken out and a temperature insulation pad is installed. The detachable cold storage component is ready.

[0034] Step 2: insert the syringe base into the detachable cold storage part, fix the syringe base and the detachable cold storage part relatively, then remove the insulation cover, install the needle on the connecting nozzle, and then perform the operation of sucking or injecting the temperature-sensitive gel;

[0035] 2 ml of the thermosensitive gel prepared in an ice bath below 4°C is drawn and injected directly after drawing, or, after drawing the thermosensitive gel, the thermosensitive gel is temporarily kept in the syringe base for transportation, and the thermostatic cover is installed, with the rubber cushion against the connection nozzle for later use;

[0036] Step 3: Perform the injection operation by holding the insulation pad with one hand and slowly pushing the injection push rod with the other hand;

[0037] Step 4: First, pull the needle out of the connecting nozzle and collect the needle in the medical waste sharps box. Secondly, separate the syringe base from the detachable cooling part. The syringe base is a disposable device and is collected in the medical waste box, while the detachable cooling part is a recyclable device. After removing the insulation pad, the detachable cooling part can be placed in a -20 ℃ refrigerator again for a few hours before it can be used again.

[0038] Compared with the prior art, the present invention has the following beneficial effects:

[0039] 1) By adding a detachable cold storage component on the periphery of the syringe base, the detachable cold storage component includes an outer cold storage cavity and an insulation layer arranged inside and outside, ensuring a low temperature environment inside the syringe to meet the actual needs of temporary storage and short-distance transportation of temperature-sensitive gel in a low temperature environment.

[0040] 2) By adding a removable insulation pad outside the insulation layer, it is possible to avoid the gel in the barrel being affected by the temperature of the operator's fingers during the injection operation, which may cause local fluidity reduction and viscosity increase, or local solution-gel phase transition to occur prematurely, causing needle blockage and affecting the injection operation.

[0041] 3) By marking scale lines on the piston rod, the real-time changes in the amount of liquid in the syringe barrel can be clearly seen, making it easier to control the injection volume and speed.

[0042] 4) The syringe barrel and the coolant chamber are independent of each other and can be disassembled or combined as needed. The coolant in the coolant chamber can be reused and can be replaced when necessary, which is economical and convenient and avoids unnecessary waste. BRIEF DESCRIPTION OF THE DRAWINGS

[0043] Figure 1 A cross-sectional view of a detachable cooling storage component and a syringe base in a combined state according to a specific embodiment 1 of the present invention;

[0044] Figure 2 A cross-sectional view of a needle, a detachable cooling storage component and a syringe base in a combined state according to a specific embodiment 1 of the present invention;

[0045] Figure 3 It is a cross-sectional view of a detachable cooling storage component according to a specific embodiment 1 of the present invention;

[0046] Figure 4 is a cross-sectional view of a syringe base according to a specific embodiment 1 of the present invention;

[0047] Figure 5 It is a cross-sectional view of the connection position between the syringe base and the detachable cooling storage member of the specific embodiment 1 of the present invention in a locked state;

[0048] Figure 6 It is a cross-sectional view of the syringe base and the detachable cooling storage component in the specific embodiment 1 of the present invention when the connection position is in a loosened state.

[0049] In the figure, 1 is the syringe base, 2 is the detachable cold storage part, 3 is the needle, 4 is the thermal insulation cover, 5 is the rubber cushion, 6 is the thermal insulation pad, 11 is the upper arc-shaped boss, 12 is the injection barrel, 13 is the piston part, 14 is the push rod part, 15 is the connecting nozzle, 21 is the outer layer cold storage agent cavity, 22 is the thermal insulation layer, 23 is the limiting extension part, 24 is the limiting plate, and 25 is the arc-shaped protrusion. DETAILED DESCRIPTION

[0050] See also Figures 1 to 6, Specific embodiment 1, a syringe suitable for temperature-sensitive gel, comprising a syringe base 1, the syringe base 1 comprising a syringe barrel 12 and an injection push rod, the end of the syringe barrel 1 is a connection nozzle 15 for detachably connecting a needle 3, and also comprising a detachable cold storage component 2, the detachable cold storage component 2 comprises an outer cold storage cavity 21 and a heat insulation layer 22 arranged inside and outside, a storage cavity for accommodating the syringe base 1 is arranged in the center of the outer cold storage cavity, and both ends of the storage cavity in the axial direction are open; the top of the storage cavity is rotatably engaged with the syringe barrel; the bottom of the storage cavity is provided with a limiting extension portion 23 for resisting the connection nozzle 15, the inner wall of the storage cavity, the limiting extension portion 23 The connecting nozzle 15 forms an annular space for the detachable connecting needle 3; the outer layer refrigerant cavity 21 is provided with a storage space for storing refrigerant and is annularly arranged around the outer periphery of the storage cavity, and the top of the outer layer refrigerant cavity 21 is provided with an injection port for docking the storage space, and the injection port is detachably connected with a sealing plug; the outer wall of the outer layer refrigerant cavity 21 is covered with a heat insulation layer 22, and the area of ​​the heat insulation layer 22 adjacent to the connecting nozzle 15 is detachably connected with a heat insulation pad 6 for hand grasping; the detachable refrigerant 2 also includes a heat insulation cover 4, which is detachably connected to the outer wall of the heat insulation layer 22, and a rubber cushion 5 for resisting the connecting nozzle 15 is fixed inside the heat insulation cover 4. The present invention optimizes the structure of the syringe, and the syringe base 1 and the detachable refrigerant 2 are independent of each other, and the two can be disassembled or combined according to needs, and the refrigerant in the outer layer refrigerant cavity 21 can be reused and can be replaced when necessary, which is economical and convenient, and avoids unnecessary waste.

[0051] The top of the syringe 12 is provided with an upper arc-shaped boss 11. The top of the storage cavity is provided with a reaming portion, and the reaming portion is provided with upper and lower limit plates 24 and limit steps. There are at least two limit plates 24, and the gap between at least two limit plates 24 is an avoidance gap for axial insertion of the upper arc-shaped boss 11. Between the limit plate 24 and the limit step is a clamping groove for locking the upper arc-shaped boss 11. The inner diameter of the limit plate 24 and the limit step matches the inner diameter of the storage cavity. See him 5 and Figure 6 When the connection position between the syringe base and the detachable cold storage part is in a locked state, the upper arc-shaped boss is clamped between the limit plate and the limit step. When the connection position between the syringe base and the detachable cold storage part is in a loose state, the vertical projection of the upper arc-shaped boss is located at the gap between the adjacent limit plates, which is convenient for axial relative separation.

[0052] The injection push rod comprises a push rod portion 14 and a piston portion 13 which are arranged up and down. The push rod portion 14 is provided with scale lines along the length direction.

[0053] The heat-insulating cover 4 is rotatably engaged with the heat-insulating layer 22 ; the outer wall of the heat-insulating layer 22 is provided with two arc-shaped protrusions 25 arranged opposite to each other; the inner wall of the heat-insulating cover is provided with a rotatable engaging groove for rotatably engaging the arc-shaped protrusions 25 .

[0054] The insulation layer 22 includes an insulation sponge, aluminum foil and a plastic matrix arranged in sequence from the inside to the outside. The plastic matrix is ​​fixedly connected to the outer wall of the outer heat storage cavity to form an annular cavity for accommodating the insulation sponge. The annular cavity is arranged around the outer periphery of the outer coolant cavity 21.

[0055] Thermal insulation sponge is a composite sponge foamed from polyethylene film and ethylene-vinyl acetate copolymer.

[0056] The coolant is a mixed solution of 25 mL of water and sodium polyacrylate.

[0057] The axial thickness of the upper and lower ends of the insulation pad is greater than the axial thickness of the middle part of the insulation pad; the thickness of the thickest part of the insulation pad is 5 mm, and the thickness of the thinnest part is 2 mm. This can effectively prevent the temperature of the injector's finger pulp from affecting the temperature-sensitive gel in the cavity during injection.

[0058] The thermosensitive gel is a liquid gel cross-linked with chitosan and sodium β-glycerophosphate.

[0059] The needle 3 comprises a plastic connection port and a metal needle which are connected in sequence, and the inner wall of the plastic connection port is connected with a frosted coating, so as to be tightly connected with the connection nozzle 15 to prevent liquid leakage.

[0060] The inner diameter of the injection syringe is 13 mm, the outer diameter is 14 mm, the axial length of the injection syringe is 64 mm, the total volume is 2.5 mL, and the material of the injection syringe is polypropylene or polycarbonate; the wall thickness of the outer coolant cavity 21 is 1 mm, and the axial length of the outer coolant cavity 21 is 70 mm; the diameter of the outer inner wall of the annular space is 14 mm.

[0061] A method for using a syringe suitable for a temperature-sensitive gel comprises the following steps:

[0062] Step 1: The refrigerant is filled or replaced through the injection port at the top of the outer refrigerant cavity 21;

[0063] The removable cooling element 2 is placed in a -20°C refrigerator for 4 hours to solidify the cooling agent, and then taken out and installed with a heat-insulating pad 6. The removable cooling element 2 is ready.

[0064] Step 2: insert the syringe base 1 into the detachable cooling member 2, fix the syringe base 1 and the detachable cooling member 2 relatively, then remove the insulation cover 4, install the needle 3 on the connecting nozzle 15, and then perform the operation of sucking or injecting the temperature-sensitive gel;

[0065] 2 ml of the thermosensitive gel prepared in an ice bath below 4°C is drawn and injected directly after drawing, or, after drawing the thermosensitive gel, the thermosensitive gel is temporarily kept in the syringe base 1 for transportation, and the heat-insulating cover 4 is installed, and the rubber cushion 5 is pressed against the connecting nozzle 15 for later use;

[0066] Step 3: Perform the injection operation by holding the insulation pad with one hand and slowly pushing the injection push rod with the other hand;

[0067] Step 4: First, pull the needle 3 out of the connecting nozzle 15 and collect the needle 3 in the medical waste sharps box. Secondly, separate the syringe base 1 from the detachable cooling part 2. The syringe base 1 is a disposable device and is collected in the medical waste box, while the detachable cooling part 2 is a recyclable device. After removing the insulation pad, the detachable cooling part can be placed in a -20 ℃ refrigerator again for a few hours before it can be used again.

[0068] The above are only preferred embodiments of the present invention. It should be pointed out that, for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

Claims

1. A syringe suitable for temperature-sensitive gel, comprising a syringe base, the syringe base comprising a syringe barrel and an injection push rod, the end of the syringe barrel is a connection nozzle for detachably connecting a needle, characterized in that: It also includes a detachable cold storage component, the detachable cold storage component includes an outer cold storage cavity and a heat insulation layer arranged inside and outside, a receiving cavity for accommodating the syringe base is arranged at the center of the outer cold storage cavity, and both ends of the receiving cavity in the axial direction are open; The top of the receiving chamber is rotatably engaged with the injection cylinder; The bottom of the storage cavity is provided with a limiting extension portion for abutting against the connecting nozzle, and the inner wall of the storage cavity, the limiting extension portion and the connecting nozzle form an annular space for a detachable connecting needle; The outer layer refrigerant cavity is provided with a storage space for storing refrigerant and is annularly arranged around the outer periphery of the storage cavity. The top of the outer layer refrigerant cavity is provided with an injection port connected to the storage space, and the injection port is detachably connected with a sealing plug; The outer wall of the outer layer refrigerant cavity is covered with the heat insulation layer, and a temperature insulation pad for hand gripping is detachably connected to the area of ​​the heat insulation layer adjacent to the connection nozzle; The detachable cold storage component also includes a thermal insulation cover, which is detachably connected to the outer wall of the heat insulation layer, and a rubber cushion for resisting the connecting mouth is fixed inside the thermal insulation cover.

2. A syringe suitable for temperature-sensitive gel according to claim 1, characterized in that: The injection push rod comprises a push rod portion and a piston portion which are arranged up and down, and the push rod portion is provided with scale lines along the length direction.

3. A syringe suitable for temperature-sensitive gel according to claim 1, characterized in that: The thermal insulation cover is rotatably engaged with the thermal insulation layer; The outer wall of the heat insulation layer is provided with two arc-shaped protrusions arranged opposite to each other; The inner wall of the heat insulation cover is provided with a rotation clamping groove for rotationally clamping the arc-shaped protrusion.

4. A syringe suitable for temperature-sensitive gel according to claim 1, characterized in that: The thermal insulation layer includes a thermal insulation sponge, aluminum foil and a plastic matrix arranged in sequence from the inside to the outside. The plastic matrix is ​​fixedly connected to the outer wall of the outer heat storage cavity to form an annular cavity for accommodating the thermal insulation sponge. The annular cavity is arranged around the outer periphery of the outer coolant cavity.

5. A syringe suitable for temperature-sensitive gel according to claim 1, characterized in that: The heat-insulating sponge is a composite sponge foamed from a polyethylene film and an ethylene-vinyl acetate copolymer.

6. A syringe suitable for temperature-sensitive gel according to claim 1, characterized in that: The coolant is a mixed solution of 25 mL of water and sodium polyacrylate.

7. A syringe suitable for temperature-sensitive gel according to claim 1, characterized in that: The axial thickness of the upper and lower ends of the thermal insulation pad is greater than the axial thickness of the middle portion of the thermal insulation pad; The thickness of the thermal insulation pad is 5 mm at the thickest part and 2 mm at the thinnest part.

8. The syringe suitable for temperature-sensitive gel according to claim 1, characterized in that: The thermosensitive gel is a liquid gel cross-linked with chitosan and sodium beta-glycerophosphate.

9. A syringe suitable for temperature-sensitive gel according to claim 1, characterized in that: The needle head comprises a plastic connection port and a metal needle which are connected in sequence, and the inner wall of the plastic connection port is connected with a frosted coating.

10. The method for using a syringe suitable for a temperature-sensitive gel according to claim 1, characterized in that: The steps include: Step 1: filling or replacing the coolant through the injection port at the top of the outer coolant cavity; The detachable cold storage component is placed in a -20°C refrigerator for 4 hours to solidify the cold storage agent, and then taken out and a temperature insulation pad is installed. The detachable cold storage component is ready. Step 2: insert the syringe base into the detachable cold storage part, fix the syringe base and the detachable cold storage part relatively, then remove the insulation cover, install the needle on the connecting nozzle, and then perform the operation of sucking or injecting the temperature-sensitive gel; 2 ml of the thermosensitive gel prepared in an ice bath below 4°C is drawn and injected directly after drawing, or, after drawing the thermosensitive gel, the thermosensitive gel is temporarily kept in the syringe base for transportation, and the thermostatic cover is installed, with the rubber cushion against the connection nozzle for later use; Step 3: Perform the injection operation by holding the insulation pad with one hand and slowly pushing the injection push rod with the other hand; Step 4: First, pull the needle out of the connecting nozzle and collect the needle in the medical waste sharps box. Secondly, separate the syringe base from the detachable cooling part. The syringe base is a disposable device and is collected in the medical waste box, while the detachable cooling part is a recyclable device. After removing the insulation pad, the detachable cooling part can be placed in a -20 ℃ refrigerator again for a few hours before it can be used again.

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