Subcutaneous infusion device

Abstract

The invention provides a subcutaneous infusion device. The subcutaneous infusion device comprises a base, a first sealing part, a second sealing part, a first cover body and a second cover body, the base is provided with an infusion cavity which is provided with a first opening, a second opening and a third opening. The second opening is used for the indwelling catheter to penetrate through; the first sealing part blocks the first opening; the second sealing part blocks the third opening; wherein the first axis and the second axis are arranged at an angle; the first cover body and the second cover body are detachably connected with the base respectively; the first cover body is provided with a puncture needle hole, and when the first cover body is connected with the base, the puncture needle is allowed to penetrate through the first sealing part along the first axis through the puncture needle hole to penetrate into the indwelling catheter; the second cover body is provided with an infusion needle connecting part arranged along a second axis, and when the second cover body is connected with the base, an infusion needle connected with the infusion needle connecting part penetrates through the second sealing part along the second axis to be communicated with the infusion cavity.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a subcutaneous infusion device. BACKGROUND

[0002] With the expansion of patient population such as diabetes, hypogonadotropic hypogonadism, and the like, infusion devices for intermittent or continuous subcutaneous infusion of drugs such as insulin tend to be widely used.

[0003] Such infusion devices can generally be divided into two types of subcutaneous hard needles and subcutaneous soft needles. The subcutaneous hard needle has the advantages of simple structure, high reliability, not easy to block, low cost, etc., but the subcutaneous hard needle made of stainless steel often brings obvious pain with human activity after being implanted subcutaneously. The subcutaneous soft needle has relatively good affinity with subcutaneous tissue after being implanted.

[0004] However, the existing infusion device is difficult to simply and reliably consider the safety disconnection and connection of infusion. SUMMARY

[0005] The purpose of the present application is to provide a subcutaneous infusion device to solve the problem that the existing infusion device is difficult to simply and reliably consider the safety disconnection and connection of infusion.

[0006] To solve the above technical problems, the present application provides a subcutaneous infusion device, comprising: a base, a first sealing part, a second sealing part, a first cover body and a second cover body;

[0007] The base has an infusion cavity, the infusion cavity has a first opening and a second opening along a first axis, and a third opening along a second axis; the second opening is used for the indwelling catheter to pass through; the first sealing part is blocked at the first opening; the second sealing part is blocked at the third opening; wherein the first axis and the second axis are arranged at an angle; the first cover body and the second cover body are respectively detachably connected with the base;

[0008] The first cover body has a puncture needle hole, when the first cover body is connected with the base, the puncture needle is allowed to pass through the first sealing part along the first axis through the puncture needle hole and enter the indwelling catheter;

[0009] The second cover body has an infusion needle connecting part along the second axis, when the second cover body is connected with the base, the infusion needle connected with the infusion needle connecting part passes through the second sealing part along the second axis and communicates with the infusion cavity.

[0010] Optionally, the first sealing part includes a first sealing block with elasticity;

[0011] The first cover or the base has a first accommodating cavity along the first axis, which is communicated with the puncture needle hole and the first opening respectively; the first sealing block is accommodated in the first accommodating cavity, blocks the puncture needle hole and allows the puncture needle to pass through;

[0012] After the puncture needle exits from the first sealing block, the first sealing block closes the hole formed by the puncture needle passing through based on elasticity.

[0013] Optionally, the first sealing part further comprises a sealing ring;

[0014] The first cover or the base further has a second accommodating cavity extending circumferentially around the first axis; the sealing ring is accommodated in the second accommodating cavity;

[0015] The first cover locks the sealing ring by connecting with the base, and the sealing ring and the first sealing block are used for blocking the first opening.

[0016] Optionally, the first sealing part further comprises a first limiting sleeve; the base has the first accommodating cavity, which is communicated with the first opening; the first limiting sleeve locks the first sealing block by connecting with the base, so that the first sealing block blocks the first opening.

[0017] Optionally, the subcutaneous infusion device further comprises a catheter seat for connecting with the indwelling catheter;

[0018] The catheter seat has a first inner cavity through along the first axis, which is communicated with a second inner cavity of the indwelling catheter;

[0019] The catheter seat comprises a liquid passing section and an abutting section; the liquid passing section is located in the infusion cavity, and the liquid passing section has a liquid passing opening through the side wall thereof;

[0020] The abutting section is arranged in the second opening and is limited by the second opening to a position away from the first sealing part.

[0021] Optionally, one end of the second opening communicated with the infusion cavity has a limiting flared portion; the limiting flared portion is matched with the outer contour shape of the abutting section in shape; the limiting flared portion limits the position of the catheter seat away from the first sealing part by abutting with the abutting section.

[0022] Optionally, the catheter seat further comprises a connecting section; the connecting section is connected to one end of the abutting section away from the liquid passing section;

[0023] The subcutaneous infusion device further comprises an indwelling catheter; the indwelling catheter comprises an expanding section, which is sleeved outside the connecting section.

[0024] Optionally, the expansion section is sleeved outside the connecting section by interference fit, and then is sleeved in the second opening by interference fit.

[0025] Optionally, the second sealing part comprises a second limiting sleeve and a second sealing block with elasticity; the base has a third accommodating cavity along the second axis; the third accommodating cavity is in communication with the third opening; the second sealing block is accommodated in the third accommodating cavity, the second limiting sleeve locks the second sealing block by being connected with the base, the second sealing block blocks the third opening and allows the infusion needle to pass through;

[0026] After the infusion needle exits from the second sealing block, the second sealing block closes the hole formed by the infusion needle passing through based on elasticity.

[0027] Optionally, the first cover body has a first buckle, the base has a second buckle, when the first cover body is connected with the base, the first buckle and the second buckle are buckled along the direction of the first axis to lock the first cover body and the base; and / or

[0028] The second cover body has a third buckle, the base has a fourth buckle, when the second cover body is connected with the base, the third buckle and the fourth buckle are buckled along the direction of the second axis to lock the second cover body and the base.

[0029] Optionally, one of the second cover body and the base has a guide rail extending along the direction of the second axis; the other of the second cover body and the base has a guide part; the guide rail is used to guide the guide part to move along the direction of the second axis and limit the position of the guide part along the direction of the first axis.

[0030] Optionally, the guide rail comprises a limiting piece perpendicular to the first axis, the guide part comprises a first guide piece and a second guide piece, the first guide piece and the second guide piece are respectively used to abut against two sides of the limiting piece along the direction of the first axis; and / or

[0031] The guide rail comprises at least two first swing limiting surfaces, the at least two first swing limiting surfaces are arranged facing each other or away from each other along the direction perpendicular to the first axis and perpendicular to the second axis; the guide part comprises at least two second swing limiting surfaces, the at least two second swing limiting surfaces are respectively used to abut against the at least two first swing limiting surfaces.

[0032] Optionally, the subcutaneous infusion device further comprises a puncture needle seat detachably connected with the first cover; the puncture needle seat comprises a puncture needle accommodating portion and a bending portion, the puncture needle accommodating portion and the bending portion are bendably connected around a bending axis which is at an angle with the first axis;

[0033] When the puncture needle seat is connected with the first cover, a puncture needle connected with the puncture needle accommodating portion penetrates the first sealing portion through the puncture needle hole and enters the indwelling catheter;

[0034] When the puncture needle seat is separated from the first cover, the puncture needle is withdrawn from the first sealing portion, and the bending portion is configured to bend relative to the puncture needle accommodating portion around the bending axis to bend and close the puncture needle.

[0035] Optionally, the puncture needle accommodating portion has a fifth buckle, the bending portion has a sixth buckle, and the bending portion is configured to bend relative to the puncture needle accommodating portion around the bending axis until the fifth buckle and the sixth buckle are buckled to lock the puncture needle bent with the bending portion.

[0036] Optionally, the subcutaneous infusion device further comprises an infusion needle and an infusion tube coaxially connected;

[0037] The infusion needle connecting portion comprises an infusion tube connecting hole and an infusion needle penetrating hole opened on the second cover along the second axis; the infusion tube is inserted into the infusion tube connecting hole and is in sealing connection with the infusion tube connecting hole; the infusion needle penetrates through the infusion needle penetrating hole;

[0038] When the second cover is connected with the base, the infusion needle penetrates through the second sealing portion and communicates with the infusion cavity.

[0039] Optionally, the infusion needle further has a side hole through the side wall.

[0040] In summary, the subcutaneous infusion device provided by the present application comprises a base, a first sealing part, a second sealing part, a first cover and a second cover; the base has an infusion cavity, the infusion cavity has a first opening and a second opening along a first axis, and a third opening along a second axis; the second opening is used for passing a catheter; the first sealing part blocks the first opening; the second sealing part blocks the third opening; the first axis and the second axis are arranged at an angle; the first cover and the second cover are respectively detachably connected with the base; the first cover has a puncture needle hole, when the first cover is connected with the base, the puncture needle can pass through the puncture needle hole along the first axis, pass through the first sealing part and enter the catheter; the second cover has an infusion needle connecting part along the second axis, when the second cover is connected with the base, the infusion needle connected with the infusion needle connecting part passes through the second sealing part along the second axis and communicates with the infusion cavity.

[0041] In this way, the puncture needle passes through the first sealing part along the first axis and enters the catheter, which can be used for implanting the catheter subcutaneously. Then, after the puncture needle is withdrawn, the first sealing part can block the first opening. When the second cover carries the infusion needle and is connected with the base, the infusion needle can pass through the second sealing part along the second axis and enter the infusion cavity, so as to establish an infusion passage. When it is necessary to disconnect the infusion passage safely, the second cover carrying the infusion needle is separated from the base, and after the infusion needle is withdrawn, the second sealing part can block the third opening. Therefore, under the condition of high pressure required for infusion, the safe disconnection or connection of the infusion passage can be realized conveniently and reliably.

[0042] Further, since the first sealing part and the second sealing part of the present embodiment are independently arranged along the first axis and the second axis respectively, the puncture or withdrawal of the puncture needle only extrudes or drives the first sealing part in the direction of the first axis, and does not affect the second sealing part. Similarly, the puncture or withdrawal of the infusion needle only extrudes or drives the second sealing part in the direction of the second axis, and does not affect the first sealing part. This makes the first sealing part and the second sealing part two sealing parts decoupled and not affected each other, further improving the reliability and safety. BRIEF DESCRIPTION OF DRAWINGS

[0043] Those skilled in the art will understand that the provided drawings are used to better understand the present application, and do not constitute any limitation on the scope of the present application. Among them:

[0044] Figure 1 is a schematic view of the subcutaneous infusion device of the present application;

[0045] Figure 2is a cross-sectional view of the subcutaneous infusion device of an embodiment of the present application along the first axis and the second axis directions;

[0046] Figure 3 is a schematic view of the base of an embodiment of the present application;

[0047] Figure 4 is a cross-sectional view of the base of an embodiment of the present application along the first axis and the second axis directions;

[0048] Figure 5 is a bottom view of the base of an embodiment of the present application;

[0049] Figure 6 is a cross-sectional view of the base of an embodiment of the present application along the first axis and perpendicular to the second axis directions;

[0050] Figure 7 is a schematic view of the first cover of an embodiment of the present application;

[0051] Figure 8 is a cross-sectional view of the first cover of an embodiment of the present application along the first axis and the second axis directions;

[0052] Figure 9 is a cross-sectional view of the first cover of an embodiment of the present application along the first axis and perpendicular to the second axis directions;

[0053] Figure 10 is a cross-sectional view of the first sealing block of an embodiment of the present application;

[0054] Figure 11 is a cross-sectional view of the sealing ring of an embodiment of the present application;

[0055] Figure 12 is an assembly schematic view of the first cover, the base, the first sealing portion, the second sealing portion, the catheter seat and the indwelling catheter of an embodiment of the present application, which is a cross-sectional view along the first axis and the second axis directions;

[0056] Figure 13 is an assembly schematic view of the first cover, the base, the first sealing portion, the second sealing portion, the catheter seat and the indwelling catheter of an embodiment of the present application, which is a cross-sectional view along the first axis and perpendicular to the second axis directions;

[0057] Figure 14 is a schematic view of the catheter seat of an embodiment of the present application;

[0058] Figure 15 is a cross-sectional view of the catheter seat of an embodiment of the present application along the first axis direction;

[0059] Figure 16 is a cross-sectional view of the indwelling catheter of an embodiment of the present application along the first axis direction;

[0060] Figure 17 is an assembly schematic view of the catheter seat and the indwelling catheter of the embodiment of the present application, which is a cross-sectional schematic view along the first axis direction;

[0061] Figure 18 is an assembly schematic view of the base, the second sealing part, the catheter seat, the indwelling catheter and the protective sleeve of the embodiment of the present application, which is a cross-sectional schematic view along the first axis and the second axis directions;

[0062] Figure 19 is a schematic view of the second limiting sleeve of the embodiment of the present application;

[0063] Figure 20 is a cross-sectional schematic view of the second limiting sleeve of the embodiment of the present application along the second axis direction;

[0064] Figure 21 is a schematic view of the second cover of the embodiment of the present application;

[0065] Figure 22 is a bottom view of the second cover of the embodiment of the present application;

[0066] Figure 23 is an assembly schematic view of the second cover, the infusion tube and the infusion needle of the embodiment of the present application, which is a cross-sectional schematic view along the first axis and the second axis directions;

[0067] Figure 24 is an assembly schematic view of the indwelling part of the embodiment of the present application, which is a cross-sectional schematic view along the first axis and the second axis directions;

[0068] Figure 25 is an assembly schematic view of the indwelling part of the embodiment of the present application, which is a cross-sectional schematic view along the first axis and perpendicular to the second axis direction;

[0069] Figure 26 is a schematic view of the puncture needle seat of the embodiment of the present application;

[0070] Figure 27 is a cross-sectional schematic view of the puncture needle seat of the embodiment of the present application along the first axis and the second axis directions;

[0071] Figure 28 is a cross-sectional schematic view of the base of another embodiment of the present application along the first axis and the second axis directions;

[0072] Figure 29 is a schematic view of the first sealing block of another embodiment of the present application;

[0073] Figure 30 is a schematic view of the first limiting sleeve of another embodiment of the present application;

[0074] Figure 31Fig. 1 is a schematic view of a subcutaneous infusion device according to an embodiment of the present application.

[0075] Brief Description of the Drawings

[0076] 10-base; 100-infusion cavity; 11-first opening; 12-second opening; 121-limiting flared portion; 122-cylindrical section; 13-third opening; 14-second buckle; 15-fourth buckle; 16-guide rail; 161-limiting member; 162-first limiting surface; 17-first boss; 18-third boss; 19-base plate; 191-fixing patch; 192-protrusion; 193-protection sleeve mounting groove; 194-second step; 21-first sealing portion; 211-first sealing block; 212-sealing ring; 213-first limiting sleeve; 214-sealing sleeve; 215-avoidance hole; 22-second sealing portion; 221-second limiting sleeve; 222-second sealing block; 223-sealing sleeve; 224-avoidance hole; 30-first cover body; 31-puncture needle hole; 32-first buckle; 33-second boss; 34-recess; 35-stress release hole; 36-first step; 40-second cover body; 41-infusion needle connecting portion; 411-infusion tube connecting hole; 412-infusion needle passing hole; 42-guide portion; 421-first guide member; 422-second guide member; 423-second limiting surface; 43-third buckle; 44-split; 45-operation handle; 46-fourth boss; 47-avoidance space; 48-protrusion; 51-first accommodating cavity; 52-second accommodating cavity; 53-third accommodating cavity; 60-catheter base; 600-first inner cavity; 61-liquid passage section; 611-liquid passage opening; 62-abutting section; 63-connecting section; 70-remaining catheter; 700-second inner cavity; 71-expanding section; 72-main body section; 73-transition section; 81-infusion needle; 811-side hole; 82-infusion tube; 90-puncture needle base; 91-puncture needle accommodating portion; 910-through hole; 911-fifth buckle; 92-bending portion; 921-sixth buckle; 93-weak portion; 94-protection sleeve; 99-puncture needle. DETAILED DESCRIPTION

[0077] To make the objects, advantages and features of the present application more clear, the following further describes the present application in detail with reference to the accompanying drawings and specific embodiments. It should be noted that the drawings are all very simplified and not drawn to scale, and are only used to facilitate and clearly assist the purpose of describing the embodiments of the present application. In addition, the structures shown in the drawings are often part of the actual structures. In particular, the emphasis shown in each drawing is different, and sometimes different scales are used.

[0078] As used in the present disclosure, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. The term "or" is generally employed in its sense including "and / or" unless the context clearly dictates otherwise. The term "plurality" is generally employed in its sense including "at least one" unless the context clearly dictates otherwise. The term "at least two" is generally employed in its sense including "two or more" unless the context clearly dictates otherwise. In addition, the terms "first," "second," "third," etc. are used only to describe different instances and do not imply or suggest relative importance or imply a specific number of the technical features indicated. Thus, features qualified with "first," "second," "third," etc. can expressly or implicitly include one or at least two of the features. The terms "one end" and "the other end" and "proximal end" and "distal end" generally refer to two parts corresponding to each other, which include not only the end points.

[0079] The terms "proximal end" and "distal end" are defined herein with respect to a subcutaneous infusion device having one end for attaching to a human body (or implanted into the skin), and the term "distal end" refers to a position closer to the end of the subcutaneous infusion device for attaching to the human body (or implanted into the skin). In the context of manual or hand-operated applications, the term "distal end" refers to a position further away from the operator. The term "proximal end" refers to a position further away from the end of the subcutaneous infusion device for attaching to the human body (or implanted into the skin). In the context of manual or hand-operated applications, the term "proximal end" refers to a position closer to the operator.

[0080] In addition, as used in the present disclosure, "mounting", "connecting", "connection", one element "disposed" in another element should be interpreted broadly, and generally only indicates that there is a connection, coupling, cooperation or transmission relationship between the two elements, and the connection, coupling, cooperation or transmission between the two elements can be direct or indirect through intermediate elements, and cannot be understood as indicating or implying the spatial positional relationship between the two elements, i.e. one element can be in any orientation inside, outside, above, below or one side of another element, unless the context clearly indicates otherwise. For those skilled in the art, the specific meaning of the above terms in the present disclosure can be understood according to the specific circumstances. In addition, directional terms such as above, below, up, down, upward, downward, left, right, etc. are used with respect to the exemplary embodiments as they are shown in the figures, upward or upward direction is toward the top of the corresponding figure, and downward or downward direction is toward the bottom of the corresponding figure.

[0081] The purpose of the present disclosure is to provide a subcutaneous infusion device to solve the problem that existing infusion devices are difficult to simply and reliably balance the safety disconnection and connection of infusion. The following description is made with reference to the accompanying drawings.

[0082] Reference is made to Figures 1 to 4 and in conjunction with reference to Figure 23The subcutaneous infusion device provided by the embodiment of the present application comprises a base 10, a first sealing part 21, a second sealing part 22, a first cover 30 and a second cover 40. The base 10 has an infusion cavity 100, which has a first opening 11 and a second opening 12 formed along a first axis A1, and a third opening 13 formed along a second axis A2. The second opening 12 is used for passing a catheter 70. The first sealing part 21 is sealed to the first opening 11. The second sealing part 22 is sealed to the third opening 13. The first axis A1 is arranged at an angle to the second axis A2. The first cover 30 and the second cover 40 are respectively detachably connected to the base 10. The first cover 30 has a puncture needle hole 31, which allows a puncture needle 99 to pass through the first sealing part 21 along the first axis A1 through the puncture needle hole 31 and into the catheter 70 when the first cover 30 is connected to the base 10. The second cover 40 has an infusion needle connecting part 41 (see Figure 23 ) formed along the second axis A2, which is connected to an infusion needle 81 when the second cover 40 is connected to the base 10, so that the infusion needle 81 passes through the second sealing part 22 along the second axis A2 and communicates with the infusion cavity 100.

[0083] Please refer to Figures 2 to 6 In an alternative example, the base 10 comprises an elliptical base plate 19, which is provided with a plurality of components (including a first boss 17, a second buckle 14, a fourth buckle 15 and a guide rail 16, etc., which will be described later) for connecting the first cover 30 and the second cover 40, etc. Optionally, the first cover 30 is preferably detachably connected to the base 10 along the direction of the first axis A1, and the second cover 40 is preferably detachably connected to the base 10 along the direction of the second axis A2. The first axis A1 is the trajectory of the puncture needle 99, and the base plate 19 is preferably perpendicular to the first axis A1. The bottom surface (i.e. the distal surface) of the base plate 19 is used to adhere to the skin. The subcutaneous infusion device preferably further comprises a fixing patch 191, and the bottom surface of the base plate 19 is adhered to the skin through the fixing patch 191. Optionally, the bottom surface of the base plate 19 has a plurality of protrusions 192, which are used to provide more contact area when adhered to the fixing patch 191. Further, the fixing patch 191 comprises a release paper layer and a non-woven fabric adhesive layer, and the proximal side of the non-woven fabric adhesive layer is fixedly connected to the protrusions 192 by glue or other fixing means, and the distal side of the non-woven fabric adhesive layer is adhered to the release paper layer. When used, the release paper layer is torn off, and the non-woven fabric adhesive layer is adhered to the skin.

[0084] The first boss 17 is arranged on the top surface (i.e. the proximal surface) of the base plate 19 along the first axis A1, and the infusion cavity 100 is formed in the interior of the first boss 17. Please refer to Figure 4and Figure 6 , and combined with reference Figure 2 and Figure 19 The infusion chamber 100 has three openings: a first opening 11 at the top, a second opening 12 at the bottom, and a third opening 13 at the side. The first sealing portion 21 seals the first opening 11, and the second sealing portion 22 seals the third opening 13. The indwelling catheter 70 is inserted through the second opening 12. As a result, the entire infusion chamber 100 has only one outlet, the indwelling catheter 70.

[0085] The first opening 11 and the second opening 12 are coaxially connected along the first axis A1. The puncture needle 99 can be inserted from one side of the first opening 11, passing through the first sealing portion 21 and the infusion lumen 100, and then through the indwelling catheter 70. During use, the puncture needle 99 punctures the skin and inserts the indwelling catheter 70 into the subcutaneous tissue. The puncture needle 99 is then withdrawn, and the indwelling catheter 70 is now indwelled subcutaneously. Furthermore, the first sealing portion 21 can also be used to seal the hole left by the withdrawal of the puncture needle 99, thereby ensuring the sealing of the infusion lumen 100.

[0086] The second cover 40 then carries the infusion needle 81 along the second axis A2 through the second sealing portion 22 and into the infusion cavity 100, thereby establishing an infusion pathway from the infusion needle 81 through the infusion cavity 100 to the indwelling catheter 70. When the infusion pathway needs to be safely disconnected, the second cover 40 can be separated from the base 10, and the second cover 40 carrying the infusion needle 81 can be withdrawn from the second sealing portion 22. Furthermore, the second sealing portion 22 can also be used to seal the hole left after the infusion needle 81 is withdrawn to ensure the sealing of the infusion cavity 100. In this way, under the higher pressure conditions required for infusion, the safe disconnection or connection of the infusion pathway can be easily and reliably achieved. Optionally, the end of the infusion needle 81 away from the puncture into the infusion cavity 100 can be connected to the infusion tube 82, and then connected to the liquid supply end.

[0087] Please refer to Figures 7 to 13 , and combined with reference Figure 2 Optionally, the first sealing portion 21 includes a first elastic sealing block 211; the first cover 30 or the base 10 has a first accommodating cavity 51 opened along the first axis A1, and the first accommodating cavity 51 is connected to the puncture needle hole 31 and the first opening 11 respectively; the first sealing block 211 is accommodated in the first accommodating cavity 51, blocking the puncture needle hole 31 and allowing the puncture needle 99 to pass through; after the puncture needle 99 withdraws from the first sealing block 211, the first sealing block 211 closes the channel formed by the puncture needle 99 due to its elasticity. The first sealing block 211 is elastic and can be made of a material such as silicone or rubber that is easily penetrated by the puncture needle 99, and can seal the channel after the puncture needle 99 is withdrawn.

[0088] Since the first sealing part 21 and the second sealing part 22 are independently arranged along the first axis A1 and the second axis A2 respectively, the puncture or withdrawal of the puncture needle 99 will only extrude or drive the first sealing part 21 in the direction of the first axis A1, without affecting the second sealing part 22. Similarly, the puncture or withdrawal of the infusion needle 81 will only extrude or drive the second sealing part 22 in the direction of the second axis A2, without affecting the first sealing part 21. This makes the first sealing part 21 and the second sealing part 22 decoupled from each other and not affect each other, further improving the reliability and safety.

[0089] In one embodiment, the first cover 30 has the first accommodating cavity 51, i.e. the first accommodating cavity 51 is entirely formed on the first cover 30. Optionally, the first accommodating cavity 51 is a cylindrical cavity with an open distal end and a proximal end communicating with the puncture needle hole 31. The puncture needle hole 31 is formed through the first cover 30 along the first axis A1. Further, the first sealing block 211 has a frustum shape, which is used to be pressed into the first accommodating cavity 51 by interference fit. It can be understood that the small end of the first sealing block 211 enters first when being pressed in. Preferably, the taper of the side wall surface of the first sealing block 211 is 15°-30°, and after being pressed into the first accommodating cavity 51, the large bottom surface of the first sealing block 211 is flush with the open end surface of the first accommodating cavity 51.

[0090] It can be understood that the above exemplary embodiment is only an example of the first accommodating cavity 51 and is not a limitation thereof. In other embodiments, the first accommodating cavity 51 can also be formed on the base 10 (such as the embodiment shown in the figure). Figures 28 to 31 The first sealing block 211 is not limited to flush with the open end surface of the first accommodating cavity 51, and in other embodiments, the first sealing block 211 can slightly protrude from the open end surface of the first accommodating cavity 51.

[0091] Please refer to Figure 8 , Figure 9 , Figures 11 to 13 Optionally, the first sealing part 21 further comprises a sealing ring 212; the first cover 30 or the base 10 further has a second accommodating cavity 52 extending circumferentially around the first axis A1; the sealing ring 212 is accommodated in the second accommodating cavity 52; the first cover 30 locks the sealing ring 212 by connecting with the base 10, and the sealing ring 212 and the first sealing block 211 are used to block the first opening 11. The sealing ring 212 has a certain elasticity and deformation ability, and the material thereof can be silicone, rubber or polytetrafluoroethylene, etc.

[0092] In one embodiment, the first cover 30 has the second accommodating cavity 52, i.e. the second accommodating cavity 52 is formed on the first cover 30 as a whole. Optionally, the first cover 30 has a second boss 33 which is arranged to protrude distally along the first axis A1, and the second boss 33 is preferably in the shape of a cylinder, and the second accommodating cavity 52 is a ring groove formed on the outer periphery of the second boss 33. The inner diameter of the sealing ring 212 is preferably not greater than the outer diameter of the ring groove, so that the sealing ring 212 can be closely sleeved in the ring groove. Further, when the sealing ring 212 is sleeved in the ring groove, the outer surface of the sealing ring 212 should protrude out of the ring groove (i.e. the outer diameter of the sealing ring 212 is greater than the outer diameter of the second boss 33 when the sealing ring 212 is sleeved in the ring groove), so that it can be in contact with the corresponding part of the first opening 11 to achieve sealing.

[0093] Please refer to Figure 6 and Figure 12 , the inner contour shape of the first opening 11 is a cylinder which is slightly larger than the outer diameter of the second boss 33, and the inner diameter of the first opening 11 is not greater than the outer diameter of the sealing ring 212 when it is sleeved in the ring groove. Preferably, the first accommodating cavity 51 is formed on the second boss 33 along the first axis A1. When the first cover 30 is connected with the base 10, the second boss 22 with the sealing ring 212 can be inserted into the first opening 11, and the sealing ring 212 is deformed to achieve sealing and plugging of the outer part of the first opening 11, while the second boss 22 and the first sealing block 211 in the first accommodating cavity 51 of the second boss 22 achieve sealing and plugging of the inner part of the first opening 11. Thus, the first sealing part 21 achieves complete sealing and plugging of the first opening 11. Further, when the first cover 30 is connected with the base 10, the sealing ring 212 is equivalent to being locked between the ring groove and the cylindrical inner wall of the first opening 11, and cannot be pulled out along the direction of the first axis A1.

[0094] In other embodiments, the second accommodating cavity 52 can also not be formed on the first cover 30 but on the base 10, i.e. the base 10 has the second accommodating cavity 52. For example, the second accommodating cavity 52 is a ring groove formed on the cylindrical inner wall of the first opening 11, and the sealing ring 212 is clamped into the ring groove and protrudes slightly inward, so that when the second boss 33 is inserted into the first opening 11, it can also achieve sealing and plugging of the first opening 11 by extruding the sealing ring 212.

[0095] In addition, it needs to be explained that the scheme of the first sealing part 21 including two separate sealing members, the first sealing block 211 and the sealing ring 212, is only a demonstration of the first sealing part 21 and is not a limitation of the first sealing part 21. In another embodiment, please refer to Figures 28 to 31, the first sealing part 21 can also only include one elastic sealing component (such as the first sealing block 211), which can also realize the sealing of the puncture needle 99 and the sealing of the first opening 11. Alternatively, the first sealing part 21 includes the first sealing block 211 and the first limiting sleeve 213; the base 10 has the first accommodating cavity 51, which communicates with the first opening 11; the first limiting sleeve 213 locks the first sealing block 211 by being connected with the base 10, so that the first sealing block 211 seals the first opening 11.

[0096] In Figures 28 to 31 In the illustrated example, the first limiting sleeve 213 is a C-shaped cylindrical sleeve extending along the direction of the first axis A1, that is, it can be understood as a cylindrical sleeve cut in the axial direction by a part, and the cut part is not more than half of the cylindrical shape. The reason for cutting a part is to avoid the third boss 18 (see the description below). Further, one end of the first limiting sleeve 213 is open, and the other end has a sleeve 214, and the sleeve 214 is provided with an avoiding hole 215, and the inner diameter of the avoiding hole 215 is greater than the outer diameter of the puncture needle 99, so as to allow the puncture needle 99 to conveniently pass through. Preferably, the inner diameter of the first limiting sleeve 213 is matched with the outer diameter of the first boss 17, and after the first sealing block 211 is accommodated in the first accommodating cavity 51, the first limiting sleeve 213 is sleeved on the first boss 17 through the open end thereof and is connected with the first boss 17, so as to lock the first sealing block 211 in the first accommodating cavity 51. The connection mode of the first limiting sleeve 213 and the third boss 18 can be interference fit or gap fit and then glued.

[0097] Please refer to Figures 14 to 18 , and refer to Figure 12 and Figure 13 Alternatively, the subcutaneous infusion device further includes a catheter seat 60 for connecting with the indwelling catheter 70; the catheter seat 60 has a first inner cavity 600 penetrating along the first axis A1, and the first inner cavity 600 communicates with the second inner cavity 700 of the indwelling catheter 70; the catheter seat 60 includes a liquid passing section 61 and an abutting section 62; the liquid passing section 61 is located in the infusion cavity 100, and the liquid passing section 61 has a liquid passing hole 611 penetrating through the side wall thereof; the abutting section 62 is arranged in the second opening 12 and is limited by the second opening 12 to a position away from the first sealing part 21 (i.e. a position away from the distal end).

[0098] In an alternative example, the catheter seat 60 is a funnel-shaped component, the liquid passage section 61 and the abutting section 62 are funnel-shaped conical portions. The abutting section 62 is the portion extending into the second opening 12, and the liquid passage section 61 is the portion exposed outside the second opening 12, i.e. the liquid passage section 61 is located in the infusion cavity 100. The liquid passage opening 611 is arranged to communicate the inside and outside of the liquid passage section 61, i.e. to communicate the infusion cavity 100 and the first inner cavity 600. Thus, the liquid infused by the infusion needle 81 can flow into the first inner cavity 600 through the infusion cavity 100 and the liquid passage opening 611, and then be input into the subcutaneous tissue through the second inner cavity 700 in communication with the first inner cavity 600. In an alternative example, the liquid passage opening 611 is a pair of notches symmetrically arranged around the first axis A1. Of course, the number of liquid passage openings 611 is not limited to two, and it can be one or more, and it is not limited to notches, and it can also be through holes, grooves, etc.

[0099] adapted to Figure 4 the end of the second opening 12 in communication with the infusion cavity 100 has a limiting flange 121; the limiting flange 121 is adapted to the outer contour shape of the abutting section 62; the limiting flange 121 limits the position of the catheter seat 60 away from the first sealing part 21 by abutting with the abutting section 62. Please refer to Figure 12 Preferably, when the first cover 30 is connected to the base 10, the proximal end of the catheter seat 60 abuts against the first sealing block 211, and the catheter seat 60 can provide support for the first sealing block 211 to prevent the first sealing block 211 from being separated from the first accommodating cavity 51.

[0100] Further, please refer to Figures 15 to 17 the catheter seat 60 further comprises a connecting section 63; the connecting section 63 is connected to the end of the abutting section 62 away from the liquid passage section 61; the subcutaneous infusion device further comprises a retention catheter 70; the retention catheter 70 comprises an expansion section 71, and the expansion section 71 is sleeved outside the connecting section 63.

[0101] In an alternative example, the catheter seat 60 is a funnel-shaped component, the connecting section 63 is the mouth of the funnel-shaped component, which is connected to the distal end of the abutting section 62. Preferably, the distal end of the connecting section 63 is arc-shaped, which facilitates the guiding and insertion of the expansion section 71 of the retention catheter 70, and reduces the stress on the expansion section 71 and the risk of damage to the expansion section 71. Preferably, the outer diameter of the connecting section 63 is greater than the inner diameter of the expansion section 71, and the expansion section 71 is sleeved outside the connecting section 63 by interference fit.

[0102] Further, after the expansion section 71 is sleeved outside the connecting section 63 by interference fit, it is sleeved in the second opening 12 by interference fit. Please refer to Figure 4In an alternative example, the second opening 12 comprises a cylindrical section 122 in addition to the limiting flange 121. The first inner cavity 600 extends through the whole catheter seat 60 along the first axis A1. After the expansion section 71 is set on the connecting section 63, the outer diameter of the expansion section 71 is slightly larger than the inner diameter of the cylindrical section 122, so that the combination of the expansion section 71 and the connecting section 63 forms an interference fit when inserted into the cylindrical section 122, thereby sealing and plugging the second opening 12, so that the liquid in the infusion cavity 100 can only be input into the subcutaneous tissue through the first inner cavity 600 and the second inner cavity 700, and cannot leak out from the outside of the catheter seat 60 and the indwelling catheter 70.

[0103] Optionally, the indwelling catheter 70 further comprises a main section 72 and a transition section 73, wherein the main section 72 is connected to the distal end of the expansion section 71 through the transition section 73. The outer diameter of the main section 72 is smaller than the outer diameter of the expansion section 71, and the transition section 73 is preferably arc-shaped and its internal shape is adapted to the shape of the distal end of the connecting section 63. The second inner cavity 700 extends through the whole indwelling catheter 70 along the first axis A1, so that the second inner cavity 700 communicates with the first inner cavity 600.

[0104] Please refer to Figure 3 , Figure 7 , Figure 9 and Figure 13 In an alternative example, the first cover 30 has a first buckle 32, and the base 10 has a second buckle 14. When the first cover 30 is connected to the base 10, the first buckle 32 and the second buckle 14 are buckled and locked along the direction of the first axis A1 to lock the first cover 30 and the base 10. When the first buckle 32 and the second buckle 14 are buckled, they are pre-tightened to ensure reliable connection of the first cover 30 and the base 10 along the first axis A1, to ensure that the first sealing block 211, the catheter seat 60 and the indwelling catheter 70 do not come off when the infusion cavity 100 bears hydraulic pressure, and to ensure that the interference fit sealing and plugging of the sealing ring 212 to the first opening 11 does not fail. The specific structure of the first buckle 32 and the second buckle 14 can be a triangular buckle and a matching buckle slot, which can be understood and configured by those skilled in the art according to the prior art, and the present application is not limited thereto. Preferably, the first cover 30 has a stress relief hole 35 which is opened near the first buckle 32, and the stress relief hole 35 is used to release the stress caused by deformation when the first buckle 32 and the second buckle 14 are buckled. Preferably, the first cover 30 has a first step 36, and the base 10 has a second step 194 which is matched; when the first cover 30 is connected to the base 10, the first step 36 and the second step 194 are matched and buckled.

[0105] Please refer to Figures 18 to 20 , and refer to Figure 3 ,Figure 4 and Figure 12 Optionally, the second sealing part 22 comprises a second limiting sleeve 221 and a second sealing block 222 with elasticity; the base 10 has a third accommodating cavity 53 along the second axis A2; the third accommodating cavity 53 communicates with the third opening 13; the second sealing block 222 is accommodated in the third accommodating cavity 53, the second limiting sleeve 221 locks the second sealing block 222 by connecting with the base 10, the second sealing block 222 blocks the third opening 13 and allows the infusion needle 81 to pass through; after the infusion needle 81 exits from the second sealing block 222, the second sealing block 222 closes the hole formed by the infusion needle 81 passing through based on the elasticity.

[0106] In an alternative exemplary embodiment, the base 10 has a third boss 18 arranged at the side of the first boss 17 along the second axis A2, the second axis A2 is preferably perpendicular to the first axis A1, and the third boss 18 is preferably suspended from the base plate 19. Of course, in other embodiments, the second axis A2 is not limited to be perpendicular to the first axis A1, it can be arranged at an angle or be perpendicular to the first axis A1, and those skilled in the art can configure it according to the actual situation. The third accommodating cavity 53 is arranged in the third boss 18 along the second axis A2. Optionally, the third accommodating cavity 53 is a cylindrical cavity, the end away from the first boss 17 is open, and the end close to the first boss 17 communicates with the infusion cavity 100 through the third opening 13. Further, the second sealing block 222 has a truncated cone shape, which is used to be pressed into the third accommodating cavity 53 by interference fit. It can be understood that the small end of the second sealing block 222 enters first when being pressed in. Preferably, the taper of the side wall of the second sealing block 222 is 15°-30°, and after being pressed into the third accommodating cavity 53, the large end of the second sealing block 222 is flush with the open end of the third accommodating cavity 53. The material and structure of the second sealing block 222 are similar to those of the first sealing block 211, which will not be repeated here.

[0107] Please refer to Figure 19 and Figure 20In an alternative exemplary embodiment, the second limiting sleeve 221 is generally a C-shaped cylindrical sleeve extending in the direction of the second axis A2, that is, it can be understood as a cylindrical sleeve with a portion cut away in the axial direction, wherein the cut away portion is no larger than half of the cylindrical shape. The reason for cutting away a portion is to reduce the volume occupied by the second limiting sleeve 221 without affecting the limiting and fixing function, thereby facilitating the assembly of the second cover 40 and the base 10. Furthermore, one end of the second limiting sleeve 221 is open, and the other end has a sleeve 223. The sleeve 223 is provided with an escape hole 224. The inner diameter of the escape hole 224 is larger than the outer diameter of the infusion needle 81 to allow the infusion needle 81 to pass through easily. Preferably, the inner diameter of the second limiting sleeve 221 matches the outer diameter of the third boss 18. After the second sealing block 222 is accommodated in the third accommodating cavity 53, the second limiting sleeve 221 is sleeved over the outside of the third boss 18 through its open end and connected to the third boss 18 to lock the second sealing block 222 in the third accommodating cavity 53. The connection between the second limiting sleeve 221 and the third boss 18 can be an interference fit or a clearance fit followed by gluing.

[0108] Please refer to Figures 21 to 24 Optionally, the subcutaneous infusion device further includes a coaxially connected infusion needle 81 and an infusion tube 82; the infusion needle connecting portion 41 includes an infusion tube connecting hole 411 and an infusion needle insertion hole 412 opened on the second cover body 40 along the second axis A2; the infusion tube 82 is inserted into the infusion tube connecting hole 411 and is sealed with the infusion tube connecting hole 411; the infusion needle 81 passes through the infusion needle insertion hole 412; when the second cover body 40 is connected to the base 10, the infusion needle 81 passes through the second sealing portion 22 and communicates with the infusion cavity 100. Furthermore, the end of the infusion tube 82 away from the infusion needle 81 is used to be connected to a liquid supply end (such as a liquid medicine bag or an infusion device, etc.). Optionally, the end of the infusion tube 82 away from the infusion needle 81 has a connector, which can be used to be detachably connected to the liquid supply end or the liquid supply catheter.

[0109] In an alternative example, the outer diameter of the infusion needle 81 is adapted to the inner diameter of the infusion tube 82, and the needle tail of the infusion needle 81 ( Figure 23 The left end of the infusion needle 81 is inserted into the lumen of the infusion tube 82 and is fixedly connected to the infusion tube 82. The needle head of the infusion needle 81 ( Figure 23 The right end of the infusion needle 81 is exposed outside the infusion tube 82 and is used to pass through the infusion needle penetration hole 412 to penetrate the second sealing portion 22. The infusion needle 81 is a hollow needle having a third inner lumen extending axially therethrough; when the infusion needle 81 is connected to the infusion tube 82, the third inner lumen communicates with the lumen of the infusion tube 82.

[0110] Optionally, the infusion tube connecting hole 411 has an open end, and the inner diameter of the infusion tube connecting hole 411 is adapted to the outer diameter of the infusion tube 82. The infusion tube 82 can be inserted into the infusion tube connecting hole 411 from the open end of the infusion tube connecting hole 411, and the infusion tube connecting hole 411 and the infusion tube 82 are in sealed connection. The infusion needle penetrating hole 412 is arranged at the end of the infusion tube connecting hole 411 away from the opening, and is in communication with the infusion tube connecting hole 411. In this way, when the infusion tube 82 is inserted into the infusion tube connecting hole 411, the infusion needle 81 can pass through the infusion needle penetrating hole 412 without obstruction. Further, the infusion needle 81 also has a side hole 811 arranged on the side wall thereof. The side hole 811 is preferably arranged at the end of the infusion needle 81 close to the needle head when the infusion needle 81 passes through the infusion needle penetrating hole 412. The arrangement of the side hole 811 outside the needle head of the infusion needle 81 additionally connects the third inner cavity and the infusion cavity 100, which can reduce the infusion pressure and increase the infusion flow. In addition, when the needle head is blocked or the drug solution is crystallized, the side hole 811 can continue to keep the drug solution unobstructed as a second passage, effectively avoiding the unexpected stop of drug infusion, and improving safety.

[0111] Please refer to Figure 21 , Figure 22 and Figure 7 , the second cover 40 and the first cover 30 have matching combination features. In an alternative example, the first cover 30 has a notch 34, which can be a waist-shaped notch, and the second cover 40 has a protrusion 48 matching the shape of the notch. When assembling, the first cover 30 is first combined with the base 10 along the first axis A1, and then the second cover 40 is combined with the base 10 along the second axis A2. When the protrusion 48 is inserted into the notch 34, the second cover 40 and the first cover 30 can be combined into one body. It can be understood that in other embodiments, the first cover 30 can have a protrusion 48, and the second cover 40 can have a notch 34. In addition, the combination features are not limited to the combination of notches and protrusions, but can also be the combination of buckles, slots, teeth, etc.

[0112] Please refer to Figures 21 to 24 , and refer to Figure 3 Optionally, the second cover 40 has a third buckle 43, and the base 10 has a fourth buckle 15. When the second cover 40 is connected to the base 10, the third buckle 43 and the fourth buckle 15 are buckled along the second axis A2 to lock the second cover 40 and the base 10.

[0113] As Figure 21As shown, in an alternative embodiment, the second cover 40 is generally semi-dome-shaped, having two slits 44 on either side of the second axis A2 and two operating handles 45 located on either side of the slits 44. A fourth boss 46 is provided below the operating handles 45, and a third latch 43 is triangularly disposed at the free end of the fourth boss 46. The provision of the slit 44 allows the fourth boss 46 and the third latch 43 to have a certain degree of deformation capability.

[0114] The fourth latch 15 is provided on the proximal end surface of the base plate 19. When the second cover 40 is assembled with the base 10 along the direction of the second axis A2, the triangular shape of the third latch 43 is pushed by the fourth latch 15 on the base 10 and deformed toward the center (toward the second axis A2) when it contacts the fourth latch 15 on the base 10. After it passes the fourth latch 15, it elastically returns to its original position and engages with the fourth latch 15.

[0115] Furthermore, the second cover 40 has a certain amount of avoidance space 47 on both sides of the third buckle 43. When it is necessary to safely disconnect the infusion path, the operating handle 45 can be pressed. Based on the setting of the slit 44, the operating handle 45 can drive the third buckle 43 to deform toward the middle through the fourth boss 46. When it passes over the fourth buckle 15, the third buckle 43 is unlocked from the fourth buckle 15. At this time, the second cover 40 can be driven to move along the direction of the second axis A2 away from the base 10, thereby separating the second cover 40 from the base 10. Preferably, the operating handle 45 can be provided with a pattern, protrusion or groove for increasing friction.

[0116] When the third and fourth latches 43 and 15 are engaged, they are pre-tightened, ensuring a secure connection between the second cover 40 and the base 10 along the second axis A2, ensuring that the infusion needle 81 reliably penetrates the second sealing block 222 without unintended detachment. To safely disconnect the infusion path, simply press the operating handle 45, making this operation convenient.

[0117] Please refer to Figure 3 and Figure 21 Optionally, one of the second cover 40 and the base 10 includes a guide rail 16 extending along the second axis A2; the other includes a guide portion 42. The guide rail 16 is used to guide the guide portion 42 along the second axis A2 and limit the position of the guide portion 42 along the first axis A1. The second cover 40 is assembled and connected to and separated from the base 10 along the second axis A2. The provision of the guide rail 16 and the guide portion 42 extends the guiding distance between the second cover 40 and the base 10 during assembly, making the guidance of the second cover 40 along the second axis A2 more accurate.

[0118] In an alternative exemplary embodiment, the base 10 is provided with the guide rail 16, and the second cover 40 is provided with the guide portion 42. The guide rail 16 includes a limiting member 161 which is perpendicular to the first axis A1, and the guide portion 42 includes a first guide member 421 and a second guide member 422 which are respectively arranged to abut against two sides of the limiting member 161 along the direction of the first axis A1. The limiting member 161 is substantially a strip which is parallel to the base 10, and the first guide member 421 and the second guide member 422 are respectively arranged on the upper and lower sides of the limiting member 161 to limit the displacement of the second cover 40 along the direction of the first axis A1, i.e. to limit the upward and downward movement of the second cover 40. It is appreciated that in other embodiments, the guide rail 16 can be arranged on the second cover 40, and the guide portion 42 can be arranged on the base 10.

[0119] Optionally, the guide rail 16 includes at least two first swing limiting surfaces 162 which are arranged to face each other or to be opposite to each other along a direction which is perpendicular to the first axis A1 and perpendicular to the second axis A2, and the guide portion 42 includes at least two second swing limiting surfaces 423 which are respectively arranged to abut against the at least two first swing limiting surfaces 162. Figure 3 In the exemplary embodiment shown, the guide rail 16 includes four first swing limiting surfaces 162 which are arranged on two sides of the second axis A2 and opposite to each other, and the two guide portions 42 include four second swing limiting surfaces 423 which are respectively arranged to abut against the four first swing limiting surfaces 162, i.e. the first swing limiting surfaces 162 are clamped on the left and right sides, thereby limiting the displacement of the second cover 40 along a direction which is perpendicular to the first axis A1 and perpendicular to the second axis A2, i.e. limiting the left and right swing of the second cover 40. It is appreciated that the number of the first swing limiting surfaces 162 and the second swing limiting surfaces 423 is not limited to four.

[0120] Preferably, the first swing limiting surfaces 162 and the limiting member 161 can be combined, for example, in the exemplary embodiment shown, the limiting member 161 is a strip which is parallel to the base 10, and the first swing limiting surfaces 162 are arranged on the upper and lower sides of the limiting member 161. Figure 3 In the exemplary embodiment shown, the guide rail 16 has a cross section which is in a lateral T shape along the direction of the second axis A2. It is appreciated that the second swing limiting surfaces 423 of the guide portion 42 can also be combined with at least one of the first guide member 421 and the second guide member 422. Further, the first guide member 421 and the second guide member 422 are preferably spaced apart in the direction of the second axis A2 to extend the guide distance.

[0121] Please refer to Figure 26 and Figure 27 , and refer to Figure 1 and Figure 2Optionally, the subcutaneous infusion device further comprises a puncture needle holder 90 detachably connected with the first cover 30; the puncture needle holder 90 comprises a puncture needle accommodating portion 91 and a bending portion 92, the puncture needle accommodating portion 91 and the bending portion 92 are bendably connected around a bending axis A3 which is at an angle with the first axis A1; when the puncture needle holder 90 is connected with the first cover 30, a puncture needle 99 connected with the puncture needle accommodating portion 91 penetrates the first sealing portion 21 through the puncture needle hole 31 and enters the indwelling catheter 70; when the puncture needle holder 90 is separated from the first cover 30, the puncture needle 99 is withdrawn from the first sealing portion 21, and the bending portion 92 is configured to bend relative to the puncture needle accommodating portion 91 around the bending axis A3 to bend and close the puncture needle 99. In some embodiments, the subcutaneous infusion device further comprises the puncture needle 99, which can form a combination with the puncture needle holder 90. Of course, in other embodiments, the puncture needle 99 can be a component independent of the puncture needle holder 90, and in use, it is connected with the puncture needle holder 90 to perform puncture. Further, for the convenience of description, the part of the subcutaneous infusion device other than the puncture needle 99 and the puncture needle holder 90 is referred to as the indwelling part, which mainly comprises the base 10, the first cover 30, the second cover 40, the first sealing portion 21, the second sealing portion 22, the catheter holder 60, the indwelling catheter 70, the infusion tube 82, the infusion needle 81 and other components, and preferably further comprises the fixing patch 191 and other auxiliary components. The indwelling part is the part contained in the subcutaneous infusion device when it actually performs infusion work. The combination of the puncture needle 99 and the puncture needle holder 90 is only used to help the indwelling catheter 70 to be implanted subcutaneously by puncture in use, and after puncture is completed, the combination of the puncture needle 99 and the puncture needle holder 90 will be separated from the indwelling part and discarded. The protective sleeve 94 and other components will also be separated from the base 10 before puncture is performed.

[0122] In an alternative exemplary embodiment, the puncture needle accommodating portion 91 is a substantially cylindrical member extending in the direction of the first axis A1, which has a through hole 910 matched with the outer diameter of the puncture needle 99, and the puncture needle 99 can pass through the through hole 910 and be fixedly connected therewith. In this way, only the puncture needle holder 90 needs to be operated to perform puncture with the puncture needle 99.

[0123] Optionally, the bending portion 92 is an arched member extending perpendicular to the first axis A1. It can be used to avoid the infusion tube 82 during puncture and to bend and seal the puncture needle 99 after the puncture is complete. Furthermore, the needle receiving portion 91 and the bending portion 92 are connected by a weakened portion 93. The weakened portion 93 is arranged along the bending axis A3 to facilitate bending of the puncture needle receiving portion 91 and the bending portion 92. In an alternative embodiment, the puncture needle receiving portion 91 and the bending portion 92 are integrally formed, and the weakened portion 93 is a V-shaped groove defined along the bending axis A3 at the junction of the puncture needle receiving portion 91 and the bending portion 92. In other embodiments, the puncture needle receiving portion 91 and the bending portion 92 can be separate components, with the weakened portion 93 being a flexible band connected to the puncture needle receiving portion 91 and the bending portion 92, respectively. This embodiment does not limit the specific structure of the weakened portion 93.

[0124] During puncture, the puncture needle 99 is first inserted into the through hole 910 of the puncture needle receiving portion 91 and fixedly connected thereto, forming a combination of the puncture needle 99 and the puncture needle hub 90. The bent portion 92 is then extended along the second axis A2. The entire combination is then moved distally along the first axis A1, allowing the puncture needle 99 to sequentially pass through the puncture needle hole 31, the first sealing portion 21, the catheter hub 60, and the indwelling catheter 70. At this point, the arched portion of the bent portion 92 can be sheathed outside the infusion tube 82, thereby providing clearance for the infusion tube 82.

[0125] After the puncture is completed, the entire assembly is moved toward the proximal end along the first axis A1 to withdraw the puncture needle 99 from the first sealing block 211 and the puncture needle hole 31. The entire assembly will then be discarded. However, the distal end of the puncture needle 99 is sharp and can easily injure the operator or other recovery personnel. To this end, the bending portion 92 can be bent around the bending axis A3 ( Figure 27 In the middle, the bending portion 92 rotates counterclockwise around the weak portion 93). During this process, since the proximal end of the puncture needle 99 is fixed in the through hole 910 of the puncture needle receiving portion 91, the arch of the bending portion 92 will drive the distal end of the puncture needle 99 to bend together. This is equivalent to bending and sealing the sharp puncture needle 99 in the cavity formed by the arch of the bending portion 92 and the puncture needle receiving portion 91, thereby effectively preventing the puncture needle 99 from injuring people after being withdrawn.

[0126] Optionally, the puncture needle accommodating portion 91 has a fifth buckle 911, and the bending portion 92 has a sixth buckle 921. The bending portion 92 is configured to bend relative to the puncture needle accommodating portion 91 around the bending axis A3 until the fifth buckle 911 and the sixth buckle 921 are engaged to lock the puncture needle 99 that is bent along with the bending portion 92.

[0127] In an alternative exemplary embodiment, the puncture needle accommodating portion 91 has an arched branch distal to the bent portion 92, and the fifth snap 911 is a protrusion disposed inward on the arched branch. In adaptation, the sixth snap 921 is a flange disposed at the opening of the arch of the bent portion 92, i.e. the sixth snap 921 is in the shape of Ω with the cross section of the bent portion 92. In this way, when the bent portion 92 is bent around the bending axis A3 to snap into the arched branch of the puncture needle accommodating portion 91, the fifth snap 911 can snap into the sixth snap 921 to achieve locking, and at the same time, the puncture needle 99 is locked. At this time, the combination of the puncture needle 99 and the puncture needle seat 90 can be discarded.

[0128] Optionally, referring to Figures 1 to 4 , and in combination with Figure 18 , the subcutaneous infusion device further comprises a protective sleeve 94, which is detachably connected to the distal end of the base 10, for protecting the puncture needle 99 and / or the indwelling catheter 70. In an alternative exemplary embodiment, the protective sleeve 94 is a substantially hollow cylindrical member. In adaptation, the base 10 has a protective sleeve mounting groove 193, which is a groove open toward the distal end around the first axis A1, and the shape of the protective sleeve mounting groove 193 is adapted to the shape of the proximal end portion of the protective sleeve 94, so that the protective sleeve 94 can be inserted into the protective sleeve mounting groove 193. In some embodiments, the puncture needle 99 and / or the indwelling catheter 70 are assembled with the first sealing portion 21 and the first cover 30 at the time of factory shipment, at which time the distal end of the indwelling catheter 70 protrudes out of the base 10 and is easily damaged. The distal sharp portion of the puncture needle 99 protrudes out of the indwelling catheter 70 and is easily damaged and can injure people. Therefore, the protective sleeve 94 can be used to enclose and protect the distal sharp portion of the puncture needle 99 and / or the distal portion of the indwelling catheter 70. When in use, the protective sleeve 94 can be removed from the base 10.

[0129] In summary, the subcutaneous infusion device provided by the present application comprises a base, a first sealing part, a second sealing part, a first cover and a second cover; the base has an infusion cavity, the infusion cavity has a first opening and a second opening along a first axis, and a third opening along a second axis; the second opening is used for passing a catheter; the first sealing part blocks the first opening; the second sealing part blocks the third opening; the first axis and the second axis are arranged at an angle; the first cover and the second cover are respectively detachably connected with the base; the first cover has a puncture needle hole, when the first cover is connected with the base, the puncture needle can pass through the first sealing part along the first axis through the puncture needle hole and enter the catheter; the second cover has an infusion needle connecting part along the second axis, when the second cover is connected with the base, the infusion needle connected with the infusion needle connecting part passes through the second sealing part along the second axis and communicates with the infusion cavity. In this way, the puncture needle passes through the first sealing part along the first axis and enters the catheter, which can be used for implanting the catheter subcutaneously. Then, after the puncture needle is withdrawn, the first sealing part can block the first opening. When the second cover carries the infusion needle and is connected with the base, the infusion needle can pass through the second sealing part along the second axis and enter the infusion cavity, thereby establishing an infusion passage. When it is necessary to disconnect the infusion passage safely, the second cover carrying the infusion needle is separated from the base, and after the infusion needle is withdrawn, the second sealing part can block the third opening. Therefore, under the condition of high pressure required for infusion, the safe disconnection or connection of the infusion passage can be achieved simply and reliably. Further, since the first sealing part and the second sealing part of the embodiment are arranged independently along the first axis and the second axis respectively, the puncture or withdrawal of the puncture needle only presses or drives the first sealing part in the direction of the first axis, and does not affect the second sealing part. Similarly, the puncture or withdrawal of the infusion needle only presses or drives the second sealing part in the direction of the second axis, and does not affect the first sealing part. This makes the first sealing part and the second sealing part decoupled and not affected by each other, further improving the reliability and safety.

[0130] It should be noted that the above several embodiments can be combined with each other. The above description is only a description of the preferred embodiments of the present application, and does not limit the scope of the present application. Any modification or modification of the present application by a person skilled in the art based on the above disclosure is within the protection scope of the present application.

Claims

1. A subcutaneous infusion device, characterized in that: include: A base, a first sealing portion, a second sealing portion, a first cover, and a second cover; The base has an infusion cavity, the infusion cavity having a first opening and a second opening along a first axis, and a third opening along a second axis; the second opening is used for inserting an indwelling catheter; the first sealing portion is sealed at the first opening; and the second sealing portion is sealed at the third opening; The first axis and the second axis are arranged at an angle; the first cover and the second cover are respectively detachably connected to the base; The first cover has a puncture needle hole, which allows a puncture needle to pass through the first sealing portion along the first axis and into the indwelling catheter when the first cover is connected to the base; The second cover has an infusion needle connecting portion opened along the second axis. When the second cover is connected to the base, the infusion needle connected to the infusion needle connecting portion passes through the second sealing portion along the second axis and communicates with the infusion cavity.

2. The subcutaneous infusion device according to claim 1, characterized in that The first sealing portion includes a first sealing block having elasticity; The first cover or the base has a first accommodating cavity opened along the first axis, the first accommodating cavity being in communication with the puncture needle hole and the first opening respectively; the first sealing block is accommodated in the first accommodating cavity, and is used to block the puncture needle hole and allow the puncture needle to pass through; After the puncture needle exits from the first sealing block, the first sealing block closes the hole formed by the puncture needle passing through due to its elasticity.

3. The subcutaneous infusion device according to claim 2, characterized in that: The first sealing portion further includes a sealing ring; The first cover or the base further has a second accommodating cavity extending circumferentially around the first axis; the sealing ring is accommodated in the second accommodating cavity; The first cover locks the sealing ring by being connected to the base. The sealing ring and the first sealing block are used to seal the first opening.

4. The subcutaneous infusion device according to claim 2, characterized in that: The first sealing portion further includes a first limiting sleeve; the base has the first accommodating cavity, which is communicated with the first opening; the first limiting sleeve locks the first sealing block by connecting with the base, so that the first sealing block blocks the first opening.

5. The subcutaneous infusion device according to claim 1, characterized in that: The subcutaneous infusion device also includes a catheter seat for connecting to an indwelling catheter; The catheter hub has a first inner cavity extending along the first axis, the first inner cavity being in communication with the second inner cavity of the indwelling catheter; The catheter seat includes a liquid-passing section and an abutting section; the liquid-passing section is located in the infusion cavity, and has a liquid-passing opening that passes through its side wall; The abutting section is disposed through the second opening and is restricted by the second opening to a position away from the first sealing portion.

6. The subcutaneous infusion device according to claim 5, characterized in that: One end of the second opening communicating with the infusion cavity has a limiting expansion opening; the shape of the limiting expansion opening matches the outer contour of the abutting section; the limiting expansion opening limits the position of the catheter seat away from the first sealing portion by abutting against the abutting section.

7. The subcutaneous infusion device according to claim 5, characterized in that: The catheter seat further comprises a connecting section; the connecting section is connected to an end of the abutting section away from the fluid passing section; The subcutaneous infusion device further comprises an indwelling catheter; the indwelling catheter comprises an expansion section, and the expansion section is sleeved outside the connecting section.

8. The subcutaneous infusion device according to claim 7, characterized in that: The expansion section is sleeved on the outside of the connection section through interference fit, and then penetrates the second opening through interference fit.

9. The subcutaneous infusion device according to claim 1, characterized in that: The second sealing portion includes a second limiting sleeve and a second elastic sealing block; the base has a third accommodating cavity opened along the second axis; the third accommodating cavity is communicated with the third opening; the second sealing block is accommodated in the third accommodating cavity, and the second limiting sleeve locks the second sealing block by connecting with the base. The second sealing block blocks the third opening and allows the infusion needle to pass through. After the infusion needle exits from the second sealing block, the second sealing block closes the hole formed by the infusion needle passing through due to its elasticity.

10. The subcutaneous infusion device according to claim 1, characterized in that: The first cover has a first buckle, and the base has a second buckle. When the first cover is connected to the base, the first buckle and the second buckle are buckled along the direction of the first axis to lock the first cover and the base; and / or The second cover has a third buckle, and the base has a fourth buckle. When the second cover is connected to the base, the third buckle and the fourth buckle are buckled along the direction of the second axis to lock the second cover and the base.

11. The subcutaneous infusion device according to claim 1, characterized in that: One of the second cover and the base has a guide rail extending in the direction of the second axis; the other of the second cover and the base has a guide portion; the guide rail is used to guide the guide portion to move in the direction of the second axis and limit the position of the guide portion along the direction of the first axis.

12. The subcutaneous infusion device according to claim 11, characterized in that: The guide rail includes a limiter perpendicular to the first axis, the guide portion includes a first guide member and a second guide member, the first guide member and the second guide member are respectively used to abut against two sides of the limiter along the direction of the first axis; and / or The guide rail includes at least two first swing limit surfaces, and at least two of the first swing limit surfaces are arranged toward each other or opposite to each other in a direction perpendicular to the first axis and perpendicular to the second axis; the guide portion includes at least two second swing limit surfaces, and at least two of the second swing limit surfaces are respectively used to abut against at least two of the first swing limit surfaces.

13. The subcutaneous infusion device according to claim 1, characterized in that: The subcutaneous infusion device further comprises a puncture needle seat for detachably connecting to the first cover; the puncture needle seat comprises a puncture needle accommodating portion and a bending portion, the puncture needle accommodating portion and the bending portion being bendably connected around a bending axis that is angled with the first axis; When the puncture needle holder is connected to the first cover, the puncture needle connected to the puncture needle receiving portion passes through the puncture needle hole, through the first sealing portion, and into the indwelling catheter; When the puncture needle seat is separated from the first cover, the puncture needle withdraws from the first sealing portion, and the bending portion is configured to bend around the bending axis relative to the puncture needle accommodating portion to bend and seal the puncture needle.

14. The subcutaneous infusion device according to claim 13, characterized in that: The puncture needle accommodating portion has a fifth buckle, and the bending portion has a sixth buckle. The bending portion is configured to bend relative to the puncture needle accommodating portion around the bending axis until the fifth buckle is engaged with the sixth buckle to lock the puncture needle bent along with the bending portion.

15. The subcutaneous infusion device according to claim 1, characterized in that: The subcutaneous infusion device further comprises an infusion needle and an infusion tube that are coaxially connected; The infusion needle connecting portion includes an infusion tube connecting hole and an infusion needle insertion hole formed on the second cover along the second axis; the infusion tube is inserted into the infusion tube connecting hole and is sealed with the infusion tube connecting hole; the infusion needle passes through the infusion needle insertion hole; When the second cover is connected to the base, the infusion needle passes through the second sealing portion and communicates with the infusion cavity.

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