An insulin pump, an indwelling needle for an insulin pump

Abstract

This invention relates to the field of medical device technology, specifically to an insulin pump and an indwelling needle for the insulin pump. The indwelling needle for the insulin pump includes an indwelling needle housing, an indwelling needle, and an outer shell. The indwelling needle housing is fixedly connected to the indwelling needle, and the housing slides on the inner wall of the outer shell. A transmitter assembly is located inside the outer shell. A puncture needle is sleeved inside the indwelling needle, and a puncture needle seat is fixedly connected to the tip of the puncture needle. A through hole is formed on the side wall of the puncture needle, and a delivery assembly for delivering insulin is connected to one side of the through hole. The end of the delivery assembly away from the through hole is connected to the insulin pump housing. A connecting block is provided at the connection between the delivery assembly and the insulin pump housing, and a first silicone seal is provided at the connection between the delivery assembly and the interior of the insulin pump housing. This invention, by directly connecting the insulin pump through a through hole in the side wall of the puncture needle, and using a delivery assembly adapted to the insertion stroke of the indwelling needle and completely housed within the insulin pump housing, eliminates the need for additional manual tubing connections.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to an insulin pump and an indwelling needle for the insulin pump. Background Technology

[0002] An insulin pump is a core device for diabetes treatment that simulates the body's physiological insulin secretion pattern through continuous subcutaneous insulin infusion (CSII). Currently, the mainstream products on the market are divided into two main types: traditional tubing-type insulin pumps and catheter-free patch-type insulin pumps. Representative brands include Medtronic and Dana internationally, and Microtek, Zhikai, and Maiston domestically. The core structure of existing insulin pump products typically consists of the pump unit, infusion tubing, indwelling needle assembly, puncture assist device / transmitter, and adhesive mounting plate. Its conventional operating principle is as follows: insulin is first infused into the reservoir, completing the pre-connection of the pump body, tubing, and indwelling needle. The soft cannula with the puncture needle is then inserted into the patient's subcutaneous tissue using the puncture assist device / transmitter. After removing the puncture needle, the pump body and indwelling needle pathway are finally connected and fixed to the skin surface. A preset program controls the pump to achieve continuous infusion of basal and postprandial insulin doses.

[0003] While patch-type insulin pumps, such as the Microtech Equil, eliminate the exposed infusion tubing of traditional products, improving ease of use, they still employ a multi-component, separate architecture. The core consists of several independent components, including a reusable controller, a disposable pump body, an indwelling needle, a transmitter, and a base plate. Use requires multiple steps, including component assembly, drug storage and venting, puncture and implantation, and main unit fixation, to prepare for infusion. This multi-component, separate design leads to a cumbersome operation process. Existing products separate the base plate, indwelling needle, transmitter, pump body, and controller into multiple independent parts. Users must strictly follow the instructions to complete multiple assembly steps each time, resulting in a high operational threshold, complicated procedures, and a high risk of assembly errors. This is particularly unfriendly to elderly patients and patients with limited hand mobility. Furthermore, the need to manually connect the tubing after puncture not only increases the number of steps but also increases the risk of introducing air during connection, exacerbating pain in the patient's skin during infusion. Summary of the Invention

[0004] To address the aforementioned issues, this invention provides an insulin pump and an indwelling needle for the insulin pump. By creating a through hole in the side wall of the puncture needle, the insulin pump can be directly connected. Combined with a delivery component that is adapted to the insertion stroke of the indwelling needle and can be completely housed within the insulin pump housing, no additional manual tubing connection is required.

[0005] To achieve the above objectives, the technical solution of the present invention is as follows: An indwelling needle for an insulin pump includes an indwelling needle housing, an indwelling needle, and an outer shell. The indwelling needle housing is fixedly connected to the indwelling needle, and the indwelling needle housing is slidably fitted onto the inner side wall of the outer shell. A transmitter assembly for implanting the indwelling needle into the patient's skin is provided inside the outer shell. A puncture needle is sleeved inside the indwelling needle, and a puncture needle seat is fixedly connected to the top of the puncture needle. The outer wall of the puncture needle seat is slidably fitted onto the inner wall of the indwelling needle housing. A through hole is opened on the side wall of the puncture needle, and a delivery assembly for delivering insulin is connected to one side of the through hole. An insulin pump housing is detachably connected to the bottom of the outer shell. The end of the delivery assembly away from the through hole is connected to the interior of the insulin pump housing. The insulin pump housing is located in the axial movement trajectory of the puncture needle and the indwelling needle. A connecting block is provided at the connection between the delivery assembly and the insulin pump housing, and a first silicone seal is provided at the connection between the delivery assembly and the interior of the insulin pump housing. The transmitter assembly includes a needle holder, a first elastic element, and a second elastic element. The bottom end of the needle holder is limited and engaged with the top end of the puncture needle seat. The top end of the outer shell is provided with a pressing component for driving the rib to retract radially and releasing the axial limit. A driving element is sleeved on the outside of the needle holder. A snap-fit ​​component is provided on the side wall of the driving element for keeping the driving element and the needle holder mutually limited. The two ends of the first elastic element are fixedly connected to the inner top wall of the outer shell and the top end of the driving element, respectively. The two ends of the second elastic element are fixedly connected to the inner wall of the needle holder and the top end of the puncture needle seat, respectively. The inner wall of the housing is provided with a locking assembly for fixing and removing the insulin pump housing. The trigger end of the locking assembly is matched with the downward movement trajectory of the drive component.

[0006] The technical principles of the above solution are as follows: Insulin is infused into the insulin pump housing. The insulin passes through the first silicone seal, connecting block, and delivery assembly, and enters the through hole on the side wall of the puncture needle, filling the puncture needle and indwelling needle. Pressing the pressing assembly at the top of the outer shell causes the axial limiting structure between the needle holder and the outer shell to disengage. After the axial limiting of the needle holder is released, the first elastic element, which is in a compressed and stored state, instantly releases its elastic potential energy, pushing the drive element, needle holder, puncture needle seat, puncture needle, indwelling needle housing, and indwelling needle to move synchronously down the inner side wall of the outer shell, so that the indwelling needle and puncture needle can be inserted into the patient's subcutaneous tissue at the same time, completing the precise implantation of the indwelling needle. As the indwelling needle is inserted, the latching assembly on the side wall of the drive unit locks, fixing the drive unit and preventing it from rebounding or continuing to move. After the drive unit is locked, the limiting effect of the latching assembly on the needle holder disappears, releasing the locking relationship between the needle holder and the drive unit. At this time, the second elastic element releases its elastic potential energy, pushing the needle holder to rebound axially upward. The needle holder simultaneously drives the puncture needle seat and the puncture needle upward, allowing the puncture needle to be completely withdrawn from the indwelling needle and retracted to its initial position inside the outer shell, leaving only the indwelling needle in the patient's subcutaneous tissue for insulin delivery.

[0007] During the downward movement of the drive component, the drive component engages with the locking assembly, causing the locking assembly to displace and release its restriction on the insulin pump housing. This releases the lock between the insulin pump housing and the outer casing. At this point, simply pulling the outer casing upwards allows only the insulin pump housing and the indwelling needle to remain at the patient's injection site for continuous subcutaneous infusion.

[0008] The above approach has the following beneficial effects: 1. This solution allows for a seamless, one-click operation of the entire process, from subcutaneous implantation of the indwelling needle to automatic retraction of the puncture needle and automatic unlocking of the insulin pump housing, all by simply pressing the pressing component. This eliminates the need for users to assemble multiple parts or perform manual operations step by step, significantly reducing operational complexity and preventing the loss of parts, thus lowering usage costs.

[0009] 2. This solution achieves a fully sealed connection between the insulin pump housing and the through hole on the side wall of the puncture needle through the first silicone sealant, connecting block and delivery assembly. Insulin infusion and venting are completed before injection, avoiding pain and infusion risks caused by gas injection into the patient's subcutaneous tissue. At the same time, after the indwelling needle is inserted, it can be automatically and completely retracted into the housing by the second elastic element, leaving only the indwelling needle under the skin, avoiding the risk of needle tip exposure and puncture injury, and greatly improving the safety of the device and the stability of insulin infusion.

[0010] 3. This solution achieves stable locking of the transmitter assembly in the pre-charge state by using the snap-fit ​​component on the side wall of the drive component and the axial limiting cooperation of the needle holder. Combined with the trigger unlocking design of the pressing component, it ensures that the operation of implanting the indwelling needle is controllable.

[0011] Furthermore, the pressing assembly includes a pressing button, the lower part of which is provided with an extrusion slope, and the upper part of the driving component is provided with radially elastically deformable ribs, the extrusion slope and the ribs wedged into each other; the outer wall of the ribs is symmetrically provided with first buckles, and the ribs are connected to the end face buckles on the inner side wall of the outer shell through the first buckles.

[0012] Beneficial effects: When the pressing button is pressed, the squeezing bevel engages with the elastic rib of the needle holder. When pressed, the squeezing bevel drives the rib to retract radially inward, causing the first buckle on the rib to disengage from the buckle on the end face of the outer shell, thereby enabling the driving component to drive the needle holder to perform axial limit unlocking.

[0013] Furthermore, the latching assembly includes a second latch with radial elastic deformation, and the outer wall of the needle holder is provided with a limiting step that corresponds to and cooperates with the second latch; the inner side wall of the housing is provided with a limiting hole that corresponds to and cooperates with the second latch, and the limiting hole is used to allow the second latch to spring back and engage to lock the drive component when the drive component is inserted downward.

[0014] Beneficial effects: The second, elastically deformable latch on the drive component engages with the limiting step of the needle holder under pressure from the inner wall of the outer shell during the pre-launch state, achieving linkage and binding between the drive component and the needle holder. After the drive component descends to its designated position, the second latch springs back and engages with the limiting hole in the outer shell, locking the drive component and simultaneously releasing the limiting effect on the needle holder. Through the bidirectional limiting function of the second latch, it ensures that the drive component and the needle holder descend synchronously during the pre-launch state, improving the consistency of the indwelling needle implantation action, and automatically locks the drive component after implantation, preventing springback from affecting the indwelling needle implantation effect.

[0015] Furthermore, the delivery assembly includes a spiral catheter, one end of which penetrates the indwelling needle housing and communicates with a through hole, and the other end of which communicates with the interior of the insulin pump housing. When the indwelling needle is in the ready-to-fire state, the spiral catheter applies an axially downward pre-tightening force to the indwelling needle housing. After the indwelling needle is implanted, it drives the spiral catheter to retract into the insulin pump housing.

[0016] Beneficial effects: The pre-tightening and spring-loaded design of the spiral catheter allows it to automatically retract and retract after the indwelling needle is inserted, completely preventing the catheter from being squeezed between the indwelling needle housing and the insulin pump housing, thus avoiding blockage and ensuring long-term unobstructed insulin infusion. The spiral structure has ample room for expansion and contraction, perfectly adapting to the downward insertion stroke of the indwelling needle, preventing the tubing from falling off or leaking due to stretching.

[0017] Furthermore, the locking assembly includes a third elastic member and an L-shaped movable member. The lower end of the inner wall of the housing is provided with a laterally extending limiting groove. The movable member is located in the limiting groove. The two ends of the third elastic member are fixedly connected to the inner wall of the limiting groove and one end of the movable member, respectively. The moving part is provided with a locking hook at the end away from the limiting groove. The insulin pump housing has a locking groove corresponding to the locking hook. The moving part is provided with a guide slope on the side near the driving part. The lower outer wall of the driving part is provided with a trigger step that cooperates with the guide slope. The trigger step is used to push the moving part to move laterally when the driving part is inserted downwards, so that the locking hook disengages from the locking groove. The inner side wall of the housing is also provided with an anti-disengagement hook to limit the axial disengagement of the moving part. The anti-disengagement hook abuts against the bottom surface of the moving part.

[0018] Beneficial effects: The L-shaped moving part is pushed by the third elastic element to slide within the limiting groove. In the ready-to-launch state, the locking hook is engaged with the locking groove of the insulin pump housing to fix the housing. The downward implantation action of the driving element triggers the unlocking, eliminating the need for additional manual unlocking operation. This allows the indwelling needle implantation and housing unlocking to be completed simultaneously, greatly simplifying the operation process.

[0019] Furthermore, the delivery assembly includes a straight catheter, one end of which is connected to the inner cavity of the indwelling needle housing, and the other end of which is connected to the interior of the insulin pump housing; the length of the straight catheter is adapted to the axial implantation stroke of the indwelling needle, and after the indwelling needle is implanted into the patient's skin, the straight catheter is completely housed within the internal space of the insulin pump housing.

[0020] Beneficial effects: The linear catheter has a simple structure, requiring no special molds for molding, which significantly reduces manufacturing costs and process difficulty, and improves mass production efficiency. Furthermore, the linear catheter has lower flow resistance, resulting in smoother insulin infusion and improved infusion accuracy and long-term infusion stability.

[0021] An insulin pump for supplying insulin to an indwelling needle of the insulin pump includes a pump body located inside an insulin pump housing. The insulin pump housing also has a drug reservoir for storing insulin. The pump body pumps the insulin from the drug reservoir to the puncture needle and the indwelling needle. The bottom end of the insulin pump housing has an infusion port and a plugging port. The infusion port communicates with the drug reservoir and has a second silicone seal. The plugging port is located in the movement trajectory of the indwelling needle and the puncture needle and has a detachably connected plug.

[0022] Beneficial effects: Insulin is stored in the drug tank inside the insulin pump housing and continuously supplied to the indwelling needle system by the insulin pump. Insulin infusion is completed through the infusion port with a second silicone seal. The plugging port, together with the removable plug, ensures the passage is sealed during infusion. After infusion, the plug is removed to accommodate the axial movement of the puncture needle and the indwelling needle.

[0023] Furthermore, the bottom surface of the insulin pump housing is provided with a medical adhesive layer.

[0024] Beneficial effects: Before implantation, the device is stably fixed to the patient's skin, ensuring the accuracy of the implantation and preventing the device from shifting during the implantation process, which could cause the indwelling needle to bend or fail to implant. After implantation, the insulin pump housing and the indwelling needle can be stably fixed to the patient's body surface, preventing the indwelling needle from dislodging during daily activities and ensuring the stability of long-term infusion.

[0025] Furthermore, the insulin pump housing is also provided with a limiting ring groove, which is located on the same axis as the blocking hole, and the lower part of the indwelling needle housing is provided with a locking platform that engages with the limiting ring groove.

[0026] Beneficial effects: The locking platform at the bottom of the indwelling needle housing engages with the limiting ring groove coaxially set inside the insulin pump housing, axial locking is completed after the indwelling needle is inserted into place, preventing the indwelling needle from springing back and falling out, and ensuring the stability of subcutaneous implantation.

[0027] Furthermore, the insulin pump housing has a reserved cavity for the retraction and accommodation of the delivery components, and the reserved cavity is connected to the limiting ring groove.

[0028] Beneficial effects: The reserved cavity provides dedicated storage space for the delivery components, completely avoiding pipeline blockage caused by squeezing or bending of the delivery components, and ensuring long-term unobstructed delivery passage. Attached Figure Description

[0029] Figure 1 This is an isometric view of an embodiment of the indwelling needle for the insulin pump of the present invention; Figure 2 This is a front cross-sectional schematic diagram of an embodiment of the indwelling needle for the insulin pump of the present invention; Figure 3 This is a side cross-sectional schematic diagram of an embodiment of the indwelling needle for the insulin pump of the present invention; Figure 4 This is an isometric schematic diagram of the delivery assembly of an embodiment of the indwelling needle for an insulin pump of the present invention; Figure 5 This is an isometric schematic diagram of the delivery assembly of an alternative embodiment of the indwelling needle for the insulin pump of the present invention.

[0030] The reference numerals in the accompanying drawings of the instruction manual include: 1. Press button; 2. Limiting hole; 3. Outer shell; 4. Insulin pump housing; 5. Rib; 6. First elastic element; 7. Needle holder; 8. Second elastic element; 9. Puncture needle seat; 10. Indwelling needle housing; 11. Through hole; 12. Spiral catheter; 13. Connecting block; 14. Drug compartment; 15. Second silicone seal; 16. Puncture needle; 17. Indwelling needle; 18. Limiting ring groove; 19. Second buckle; 20. Third elastic element; 21. Moving element; 22. Locking hook; 23. Locking buckle groove; 24. Straight catheter; 25. Driving element. Detailed Implementation

[0031] The technical solution of the present invention will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0032] In the description of this invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the invention and for simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0033] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0034] The following detailed description illustrates the specific implementation method: Example 1

[0035] As attached Figure 1 and Figure 2 As shown: An indwelling needle for an insulin pump includes an indwelling needle housing 10, an indwelling needle 17, and an outer shell 3. The indwelling needle housing 10 is fixedly connected to the indwelling needle 17. The indwelling needle housing 10 is slidably fitted onto the inner wall of the outer shell 3. The outer shell 3 contains a transmitter assembly for implanting the indwelling needle 17 into the patient's skin. A puncture needle 16 is sleeved inside the indwelling needle 17. A puncture needle seat 9 is fixedly connected to the top of the puncture needle 16. The outer wall of the puncture needle seat 9 is slidably fitted onto the inner wall of the indwelling needle housing 10. A through hole 11 is opened on the side wall of the puncture needle 16, and a delivery assembly for delivering insulin is connected to one side of the through hole 11. An insulin pump housing 4 is detachably connected to the bottom of the outer shell 3. The end of the delivery assembly away from the through hole 11 communicates with the interior of the insulin pump housing 4. The insulin pump housing 4 is located in the axial movement trajectory of the puncture needle 16 and the indwelling needle 17. A connecting block 13 is provided at the connection between the delivery assembly and the insulin pump housing 4, and a first silicone seal is provided at the communication point between the delivery assembly and the interior of the insulin pump housing 4. Figure 4 As shown, the delivery assembly includes a spiral catheter 12. One end of the spiral catheter 12 passes through the indwelling needle housing 10 and communicates with the through hole 11. The other end of the spiral catheter 12 communicates with the interior of the insulin pump housing 4. When the indwelling needle 17 is in the ready-to-fire state, the spiral catheter 12 applies an axially downward pre-tightening force to the indwelling needle housing 10. After the indwelling needle 17 is implanted, the spiral catheter 12 is driven to retract into the insulin pump housing 4.

[0036] like Figure 2 and Figure 3 As shown, the transmitter assembly includes a needle holder 7, a first elastic element 6, and a second elastic element 8. The bottom end of the needle holder 7 is limited to the top end of the puncture needle seat 9. The top end of the housing 3 is provided with a pressing assembly for driving the rib 5 to retract radially and releasing the axial limit. The pressing assembly includes a pressing button 1, and the lower part of the pressing button 1 is provided with a squeezing slope.

[0037] A drive member 25 is sleeved on the outside of the needle holder 7. The upper part of the drive member 25 has radially elastically deformable ribs 5, and the extrusion slope wedges with the ribs 5. First buckles are symmetrically provided on the outer wall of the ribs 5, and the ribs 5 are connected to the end face buckles on the inner side wall of the outer casing 3 via the first buckles. The side wall of the drive member 25 is provided with a buckle assembly for maintaining the mutual positioning between the drive member 25 and the needle holder 7, as shown in the attached figure. Figure 3 As shown, the snap-fit ​​assembly includes a second snap-fit ​​19 with radial elastic deformation. The outer wall of the needle holder 7 is provided with a limiting step that corresponds to and cooperates with the second snap-fit ​​19. The inner side wall of the housing 3 is provided with a limiting hole 2 that corresponds to and cooperates with the second snap-fit ​​19. The limiting hole 2 is used to allow the second snap-fit ​​19 to spring back and snap into place to lock the drive member 25 when the drive member 25 is inserted downward.

[0038] The first elastic element 6 is fixedly connected at both ends to the inner top wall of the outer shell 3 and the top end of the drive element 25, respectively. The second elastic element 8 is fixedly connected at both ends to the inner wall of the needle holder 7 and the top end of the puncture needle seat 9, respectively.

[0039] The specific implementation process is as follows: In the initial state, the first latch and the end face latch on the inner sidewall of the outer shell 3 form a stable axial latch connection, so that the needle holder 7 is in a completely locked and stationary state in the axial direction of the outer shell 3, and cannot slide along the axial direction. At this time, the second latch 19 on the sidewall of the drive member 25 sleeved on the outside of the needle holder 7 undergoes radial inward elastic deformation under the continuous compression of the inner sidewall of the outer shell 3. The deformed second latch 19 forms a tight axial limiting fit with the limiting step on the outer wall of the needle holder 7, so that the drive member 25 and the needle holder 7 form a relatively fixed rigid connection relationship. At the same time, the first elastic member 6 is in a compressed and energy-storing state, with its two ends stably abutting against the inner top wall of the outer shell 3 and the top of the drive member 25, respectively, storing sufficient elastic potential energy for subsequent puncture action. Due to the limiting effect of the second latch 19 and the limiting step, and the axial locking state of the needle holder 7, the drive member 25 cannot move downward under the elastic force of the first elastic member 6, and the entire launcher assembly is in a stable energy-storing and ready-to-launch state.

[0040] Meanwhile, in the initial state, the top of the puncture needle seat 9 and the lower end of the needle holder 7 form a stable limiting fit. The puncture needle 16 is fixedly connected to the bottom of the puncture needle seat 9 and is completely coaxially sleeved inside the indwelling needle 17. The indwelling needle 17 is fixedly connected to the indwelling needle housing 10. The indwelling needle housing 10 is slidably fitted on the inner side wall of the outer shell 3, so that the puncture needle 16, the indwelling needle 17, the indwelling needle housing 10, the needle holder 7 and the drive member 25 form a completely coaxial axial movement path, which limits the movement trajectory of subsequent puncture actions and avoids the needle tip from deflecting at an angle during puncture.

[0041] In actual use, firstly, the required dose of insulin is infused into the insulin pump housing 4. After infusion, the insulin flows through the first silicone seal, connecting block 13 and spiral catheter 12 into the through hole 11 on the side wall of the puncture needle 16, eventually filling the entire inner cavity of the puncture needle 16 and the indwelling needle 17, completely expelling the air in the tubing until the insulin solution overflows from the tip of the indwelling needle 17, thus completing the air venting operation.

[0042] After the venting is complete, the insulin pump housing 4 is attached to the selected subcutaneous infusion site, such as the abdomen. At this time, the pressing button 1 at the top of the housing 3 is pressed. The pressing button 1 slides downward along the axis of the housing 3, and the squeezing slope at the bottom of the pressing button 1 moves downward accordingly, forming a wedge compression with the rib 5 on the upper part of the drive component 25. The vertical downward displacement of the squeezing slope is converted into a radial squeezing force on the rib 5 through the wedge structure, driving the rib 5 to undergo radial inward elastic deformation. As the rib 5 continues to retract radially, the first buckle symmetrically arranged on the outer wall of the rib 5 moves inward synchronously, and finally completely disengages from the end face buckle on the inner side wall of the housing 3, releasing the axial lock on the rib 5. At this time, the needle holder 7, drive component 25, indwelling needle housing 10, puncture needle 16 and indwelling needle 17 are no longer limited and locked.

[0043] The moment the first latch disengages from the end face latch, the first elastic element 6, which is in a compressed and stored state, instantly releases its elastic potential energy, pushing the driving element 25 downward along the axial direction of the outer shell 3 at a constant speed. Since the second latch 19 of the driving element 25 is still in a tight axial limiting fit with the limiting step on the outer wall of the needle holder 7, and the lower end of the needle holder 7 is always in a limiting fit with the top end of the puncture needle seat 9, the downward movement of the needle holder 7 will synchronously push the puncture needle seat 9 and the puncture needle 16 downward. The puncture needle 16 is coaxially sleeved inside the indwelling needle 17. The downward movement of the puncture needle 16 will drive the indwelling needle 17 to pierce the patient's subcutaneous tissue, reach the preset implantation depth, and complete the implantation of the indwelling needle 17. The puncture is driven by the elastic potential energy of the first elastic element 6, which ensures that the speed and force of the puncture action are uniform. Compared with manual puncture by the patient, it greatly reduces the cutting pain of the needle tip on the subcutaneous tissue and solves the problem of strong pain and puncture failure caused by uneven force in manual puncture in the existing technology. In addition, the downward pre-pulling force of the spiral catheter 12 on the indwelling needle housing 10 in the initial state will further pull the indwelling needle housing 10 downward during the descent of the indwelling needle 17, ensuring the stability of the indwelling needle 17 implantation and avoiding the problem of implantation jamming.

[0044] When the drive member 25 descends to the preset implantation depth, the second latch 19 moves to the position of the limiting hole 2 on the inner wall of the outer shell 3. At this time, the radial compression of the inner wall of the outer shell 3 on the second latch 19 disappears. Under the action of its own elastic restoring force, the deformed second latch 19 quickly rebounds radially outward and is locked into the limiting hole 2, forming an axial bidirectional lock on the drive member 25. This prevents the drive member 25 from continuing to descend or rebounding upward, and it is stably fixed in the preset position inside the outer shell 3, thus completing the locking of the drive member 25. At the same time, the second latch 19 disengages from the limiting step on the outer wall of the needle holder 7, and the needle holder 7 loses the limiting constraint of the drive member 25, releasing the degree of freedom of movement for the retraction of the puncture needle 16.

[0045] When the second latch 19 disengages from the limiting step, the second elastic element 8, which is in a compressed state, releases its elastic potential energy. The two ends of the second elastic element 8 are fixedly connected to the inner wall of the needle holder 7 and the top of the puncture needle seat 9, respectively. Therefore, the rebound of the second elastic element 8 will push the needle holder 7 upward rapidly along the axial direction to reset. At the same time, the upward movement of the needle holder 7 will synchronously drive the puncture needle seat 9 and the puncture needle 16 to move upward synchronously, so that the puncture needle 16 is completely withdrawn from the inside of the indwelling needle 17 and finally reset to the initial position inside the outer shell 3; while the indwelling needle 17 is left in the patient's subcutaneous tissue.

[0046] After the indwelling needle 17 is implanted, the insulin pump housing 4 and the indwelling needle 17 are stably placed on the patient's skin surface. Insulin from the insulin pump housing 4 is continuously delivered to the indwelling needle 17, and finally infused into the patient's subcutaneous tissue, achieving continuous subcutaneous insulin infusion and the therapeutic effect of blood glucose control. Throughout the entire indwelling infusion cycle, the spiral catheter 12 can be stored in the reserved space of the insulin pump housing 4, without the problem of catheter bending, compression, or blockage, ensuring the long-term patency of the insulin infusion line.

[0047] Example 2

[0048] As attached Figure 5As shown, the difference from Embodiment 1 is that, since the spiral catheter 12 requires a dedicated spiral mold and the manufacturing process is repeated, the delivery assembly can alternatively include a straight catheter 24. One end of the straight catheter 24 communicates with the inner cavity of the indwelling needle housing 10, and the other end communicates with the interior of the insulin pump housing 4. The length of the straight catheter 24 is adapted to the axial implantation stroke of the indwelling needle 17. After the indwelling needle 17 is implanted into the patient's skin, the straight catheter 24 is completely housed within the internal space of the insulin pump housing 4. The total length of the straight catheter 24 is adapted to the axial implantation stroke of the indwelling needle 17 from the initial firing position to complete implantation into the patient's skin. In the initial state, the straight catheter 24 is in a naturally straight pre-arranged state, which avoids the problem of redundant stacking of the straight catheter 24 due to excessive length or the limitation of the downward implantation of the indwelling needle 17 due to excessive length.

[0049] Example 3

[0050] As attached Figure 2 As shown, the difference from Embodiment 2 is that the inner wall of the outer shell 3 is provided with a locking assembly for fixing and disassembling the insulin pump housing 4. The trigger end of the locking assembly corresponds to the downward movement trajectory of the drive member 25. The locking assembly includes a third elastic member 20 and an L-shaped moving member 21. The lower end of the inner wall of the outer shell 3 is provided with a laterally extending limiting groove. The moving member 21 is located in the limiting groove. The two ends of the third elastic member 20 are fixedly connected to the inner wall of the limiting groove and one end of the moving member 21, respectively. The movable part 21 is provided with a locking hook 22 at the end away from the limiting groove. The insulin pump housing 4 is provided with a locking groove 23 corresponding to the locking hook 22. The movable part 21 is provided with a guide slope on the side close to the driving part 25. The lower outer wall of the driving part 25 is provided with a trigger step that cooperates with the guide slope. The trigger step is used to push the movable part 21 to move laterally when the driving part 25 is implanted downward, so that the locking hook 22 disengages from the locking groove 23. The inner side wall of the outer shell 3 is also provided with an anti-disengagement hook for limiting the axial disengagement of the movable part 21. The anti-disengagement hook abuts against the bottom surface of the movable part 21.

[0051] The specific implementation process is as follows: In the initial state, through the lateral thrust of the third elastic element 20, the locking hook 22 at the end of the moving part 21 away from the limiting slide groove is completely inserted into the corresponding locking groove 23 on the outer wall of the insulin pump housing 4, forming a rigid locking fit in both directions along the axis. This prevents the insulin pump housing 4 from being displaced relative to the outer shell 3 along the axis, ensuring that the insulin pump housing 4 and the outer shell 3 maintain a stable connection throughout the entire injection process, and preventing the problem of falling off or separating.

[0052] During puncture, the drive component 25 descends axially along the outer shell 3, and the trigger step descends synchronously with the drive component 25. When the drive component 25 descends to the preset implantation depth and the indwelling needle 17 is fully inserted into the patient's subcutaneous tissue, the trigger step precisely wedges with the guide ramp provided on the side of the moving component 21 near the drive component 25. As the drive component 25 continues to descend and the trigger step descends vertically, the wedge of the guide ramp is converted into a lateral driving force on the moving component 21, overcoming the pre-tightening thrust of the third elastic element 20, and pushing the moving component 21 to slide laterally away from the insulin pump housing 4 along the limiting groove. During the lateral sliding of the moving component 21, the locking hook 22 at its end moves laterally synchronously, and finally the locking hook 22 disengages from the locking groove 23 of the insulin pump housing 4, releasing the axial locking engagement between the locking hook 22 and the locking groove 23. At this time, the insulin pump housing 4 and the outer shell 3 are no longer locked to each other, completing automatic unlocking. The entire unlocking process is completely synchronized with the implantation of the indwelling needle 17. No manual unlocking operation is required from the user. The unlocking and separation preparation of the outer shell 3 and the insulin pump housing 4 is completed the moment the puncture is completed. The user only needs to pull the outer shell 3 upward to completely separate the transmitter assembly from the insulin pump housing 4, which greatly simplifies the operation process and avoids the tedious steps of manually disassembling the transmitter after puncture.

[0053] Example 4

[0054] As attached Figure 2 and Figure 3 As shown, the difference from Example 3 is that an insulin pump is used to supply medication to the indwelling needle 17 of the insulin pump described in Examples 1 to 3. The pump pump includes a pump body located inside the insulin pump housing 4. The bottom surface of the insulin pump housing 4 is provided with a medical adhesive layer, which can stably attach and fix the insulin pump housing 4 to the skin surface for continuous insulin infusion.

[0055] The insulin pump housing 4 is also provided with a drug reservoir 14 for storing insulin. The pump body is used to pump the insulin in the drug reservoir 14 into the puncture needle 16 and the indwelling needle 17. The bottom of the insulin pump housing 4 is provided with an infusion hole and a plugging hole. The infusion hole is connected to the drug reservoir 14 and is provided with a second silicone seal 15. The plugging hole is located in the movement trajectory of the indwelling needle 17 and the puncture needle 16 and is detachably connected with a plug.

[0056] The insulin pump housing 4 is also provided with a limiting ring groove 18, which is located on the same axis as the blocking hole. The lower part of the indwelling needle housing 10 is provided with a locking platform that engages with the limiting ring groove 18. The insulin pump housing 4 is provided with a reserved cavity for the delivery component to retract and accommodate, and the reserved cavity is connected to the limiting ring groove 18.

[0057] In use, the user first inserts the plug into the blocking hole, then takes a medical syringe containing insulin and vertically pierces the second silicone seal 15 in the infusion hole with the syringe needle, allowing the tip of the needle to extend into the medication chamber 14, infusing the insulin solution into the medication chamber 14. After infusion, the syringe needle is removed, and the second silicone seal 15 automatically closes the needle hole formed by the needle puncture due to the elastic rebound of its own medical silicone, achieving a leak-free self-sealing without the need for additional sealing operations. After infusion, the plug in the blocking hole is removed, and the pump body in the insulin pump housing 4 is activated to pump the insulin solution in the medication chamber 14 into the connected delivery assembly, ultimately filling the entire inner cavity of the puncture needle 16 and the indwelling needle 17, completely expelling air from the tip of the indwelling needle 17.

[0058] After the indwelling needle 17 is implanted subcutaneously, the locking platform is engaged in the limiting ring groove 18, so that the indwelling needle housing 10 and the insulin pump housing 4 are locked together and fixed, thus preventing the delivery component from being disconnected or leaking due to patient movement during the indwelling period.

[0059] Obviously, the above embodiments are merely illustrative examples for clear explanation and are not intended to limit the implementation. Those skilled in the art will recognize that other variations or modifications can be made based on the above description. It is neither necessary nor possible to exhaustively list all possible implementations here. However, obvious variations or modifications derived therefrom are still within the scope of protection of this invention.

Claims

1. An indwelling needle for an insulin pump, comprising an indwelling needle housing (10), an indwelling needle (17), and an outer shell (3), wherein the indwelling needle housing (10) is fixedly connected to the indwelling needle (17), and the indwelling needle housing (10) is slidably fitted onto the inner wall of the outer shell (3), characterized in that, The outer shell (3) is provided with a transmitter assembly for implanting an indwelling needle (17) into the patient's skin. A puncture needle (16) is sleeved inside the indwelling needle (17). A puncture needle seat (9) is fixedly connected to the top of the puncture needle (16). The outer wall of the puncture needle seat (9) is slidably sleeved on the inner wall of the indwelling needle housing (10). A through hole (11) is opened on the side wall of the puncture needle (16). A delivery assembly for delivering insulin is connected to one side of the through hole (11). An insulin pump housing (4) is detachably connected to the bottom of the outer shell (3). The end of the delivery assembly away from the through hole (11) is connected to the inside of the insulin pump housing (4). The insulin pump housing (4) is located in the axial movement trajectory of the puncture needle (16) and the indwelling needle (17). A connecting block (13) is provided at the connection between the delivery assembly and the insulin pump housing (4). A first silicone seal is provided at the connection between the delivery assembly and the inside of the insulin pump housing (4). The transmitter assembly includes a needle holder (7), a first elastic element (6), and a second elastic element (8). The bottom end of the needle holder (7) is limited to the top end of the puncture needle seat (9). The top end of the outer shell (3) is provided with a pressing component for driving the rib (5) to retract radially and releasing the axial limit. A driving element (25) is sleeved on the outside of the needle holder (7). A snap-fit ​​component is provided on the side wall of the driving element (25) for keeping the driving element (25) and the needle holder (7) mutually limited. The two ends of the first elastic element (6) are fixedly connected to the inner top wall of the outer shell (3) and the top end of the driving element (25), respectively. The two ends of the second elastic element (8) are fixedly connected to the inner wall of the needle holder (7) and the top end of the puncture needle seat (9), respectively. The inner wall of the outer casing (3) is provided with a locking assembly for fixing and removing the insulin pump housing (4), and the trigger end of the locking assembly is matched with the downward movement trajectory of the drive component (25); The pressing assembly includes a pressing button (1), the lower part of which is provided with an extrusion slope, and the upper part of the driving member (25) is provided with a radially elastically deformable rib (5). The extrusion slope and the rib (5) are wedged together. The outer wall of the rib (5) is symmetrically provided with a first buckle, and the rib (5) is connected to the end face buckle on the inner side wall of the outer shell (3) through the first buckle. The snap-fit ​​assembly includes a second snap-fit ​​(19) with radial elastic deformation. The outer wall of the needle holder (7) is provided with a limiting step that corresponds to and cooperates with the second snap-fit ​​(19). The inner side wall of the outer shell (3) is provided with a limiting hole (2) that corresponds to and cooperates with the second snap-fit ​​(19). The limiting hole (2) is used to allow the second snap-fit ​​(19) to spring back and snap into place to lock the drive member (25) when the drive member (25) is inserted downwards. The locking assembly includes a third elastic element (20) and an L-shaped movable element (21). The lower end of the inner wall of the housing (3) is provided with a horizontally extending limiting groove. The movable element (21) is located in the limiting groove. The two ends of the third elastic element (20) are fixedly connected to the inner wall of the limiting groove and one end of the movable element (21), respectively. The moving part (21) is provided with a locking hook (22) at the end away from the limiting groove. The insulin pump housing (4) is provided with a locking groove (23) corresponding to the locking hook (22). The moving part (21) is provided with a guide slope on the side close to the driving part (25). The lower outer wall of the driving part (25) is provided with a trigger step that cooperates with the guide slope. The trigger step is used to push the moving part (21) to move laterally when the driving part (25) is inserted downward, so that the locking hook (22) is disengaged from the locking groove (23). The inner side wall of the outer shell (3) is also provided with an anti-disengagement hook for restricting the axial disengagement of the moving part (21). The anti-disengagement hook abuts against the bottom surface of the moving part (21).

2. The indwelling needle for an insulin pump according to claim 1, characterized in that, The delivery assembly includes a spiral catheter (12), one end of which passes through the indwelling needle housing (10) and communicates with the through hole (11), and the other end of which communicates with the interior of the insulin pump housing (4). When the indwelling needle (17) is in the ready-to-fire state, the spiral catheter (12) applies an axial downward pre-tightening force to the indwelling needle housing (10). After the indwelling needle (17) is implanted, the spiral catheter (12) is driven to retract into the insulin pump housing (4).

3. The indwelling needle for an insulin pump according to claim 1, characterized in that, The delivery assembly includes a straight catheter (24), one end of which is connected to the inner cavity of the indwelling needle housing (10), and the other end of which is connected to the interior of the insulin pump housing (4). The length of the straight catheter (24) is adapted to the axial implantation stroke of the indwelling needle (17). After the indwelling needle (17) is implanted into the patient's skin, the straight catheter (24) is completely housed in the internal space of the insulin pump housing (4).

4. An insulin pump for delivering medication to an indwelling needle of the insulin pump according to any one of claims 1 to 3, characterized in that, The device includes a pump body, which is located inside an insulin pump housing (4). The insulin pump housing (4) also contains a drug reservoir (14) for storing insulin. The pump body is used to pump the insulin in the drug reservoir (14) into the puncture needle (16) and the indwelling needle (17). The bottom of the insulin pump housing (4) has an infusion hole and a plugging hole, respectively. The infusion hole is connected to the drug reservoir (14). A second silicone seal (15) is provided in the infusion hole. The plugging hole is located in the movement trajectory of the indwelling needle (17) and the puncture needle (16). A plug is detachably connected in the plugging hole.

5. The insulin pump according to claim 4, characterized in that, The bottom surface of the insulin pump housing (4) is provided with a medical adhesive layer.

6. The insulin pump according to claim 5, characterized in that, The insulin pump housing (4) is also provided with a limiting ring groove (18), which is located on the same axis as the plugging hole. The lower part of the indwelling needle housing (10) is provided with a snap-fit ​​platform that engages with the limiting ring groove (18).

7. The insulin pump according to claim 6, characterized in that, The insulin pump housing (4) has a reserved cavity for the delivery component to retract and accommodate, and the reserved cavity is connected to the limiting ring groove (18).

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