Implantable drug delivery device

Abstract

The invention discloses an implantable drug delivery device, and relates to the technical field of medical instruments, according to the implantable drug delivery device, a titanium inner shell made of titanium metal is embedded in a port body base made of plastic to form a puncture-proof cavity used for liquid storage and infusion, and the implantable drug delivery device has the characteristics of puncture prevention, scratch prevention, few generated chippings and corrosion resistance; the filter membrane is arranged on the inner shell through hole of the titanium inner cavity, so that liquid medicine impurities and puncture falling scraps are effectively filtered and prevented from entering blood or body fluid or assembling circulation; a three-way valve is further arranged in the liquid outlet direction of the through hole of the inner shell, and under the influence of normal pressure of a valve wall and a notch, flowing of liquid inside and outside the puncture-proof cavity can be effectively controlled, blood backflow is prevented, and it is guaranteed that liquid medicine is conveyed according to needs; through the structure formed by matching the plastic port body, the silica gel puncture septum and the titanium inner shell made of titanium metal, the device has the advantages of light weight, low cost, high biocompatibility and the like, the problem of artifacts in image examination is avoided, and the safety of the implantable drug delivery device and the comfort of a patient are greatly improved.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, in particular to an implantable drug delivery device. Background Art

[0002] An implantable drug delivery device or fully implantable infusion port (referred to as "infusion port") is a long-term infusion device widely used in the medical field. The infusion port usually consists of three parts: the port body, the catheter lock, and the catheter. The port body and the catheter lock are placed subcutaneously, and the catheter is inserted into the vein, artery, intraperitoneum or spinal canal through surgical implantation to establish a long-term fluid infusion or body fluid aspiration pathway for the patient. The use scenarios of this device include: long-term infusion of chemotherapy drugs, nutritional support infusion, aspiration and drainage of ascites or pleural effusion, pain management and analgesic drug infusion, blood collection, and other medical uses that require repeated use of fluid pathways.

[0003] Since the infusion port needs to be left inside the human body for a long time and has the characteristics of repeated percutaneous puncture, it provides great convenience for patients in clinical applications, while reducing the risks of injury and infection caused by traditional infusion methods.

[0004] However, the existing technology still has many problems: (1) The infusion port needs to be left in the human body for a long time. The infusion and withdrawal operations may cause air to enter the body and form an air embolism, or cause blood coagulation in the catheter due to blood backflow, thereby increasing the risk of catheter blockage and infection. These problems seriously affect the safety of patients and the functional sustainability of the device.

[0005] (2) The currently common all-plastic infusion ports are low-cost and have little impact on imaging examinations (such as MRI), but the bottom of the reservoir is made of plastic, which is easily punctured, scratched or produced by non-invasive needles. These scratches may cause lesions, blood clots or debris to form. Non-invasive needle puncture may bring in tiny plastic debris. During continuous positive pressure infusion, the debris will enter the blood circulation with the drug solution through the anti-backflow valve, further increasing the possibility of vascular damage and inflammatory response in the body.

[0006] (3) All-metal infusion ports have limitations: Although all-metal infusion ports can prevent the bottom of the reservoir from being punctured by a non-destructive needle, they have the following defects in clinical use: The heavy weight and metal material increase the burden on patients, especially affecting comfort during long-term use. The high manufacturing cost and complicated metal processing technology make the device more expensive. The metal material will produce significant artifacts in MRI examinations, affecting the accuracy of imaging diagnosis.

[0007] Although existing infusion ports have been widely used in the clinical field, they still face many technical bottlenecks. In order to solve the problems of easy puncture and scratching of the bottom of the reservoir by a non-destructive needle, blood reflux, metal artifacts, etc., it is necessary to develop an infusion port that can solve the above problems to better meet clinical needs, improve patient experience and ensure long-term safety.

[0008] In summary, it is found that the prior art has at least the following technical problems: Existing all-plastic infusion ports are easily punctured, scratched or produce chips, and all-metal infusion ports have technical problems such as heavy weight, high cost and affecting the accuracy of imaging examinations. Summary of the invention

[0009] The purpose of the present invention is to provide an implantable drug delivery device to solve the technical problems that the existing all-plastic infusion port is easily punctured, scratched or produces chips, and the all-metal infusion port is heavy, costly and affects the accuracy of imaging examination.

[0010] The various technical effects that can be produced by the preferred technical solutions among the various technical solutions provided by the present invention are described in detail below.

[0011] In order to solve the above technical problems, the present invention provides the following technical solutions: The present invention provides an implantable drug delivery device, comprising a port body made of plastic, a puncture septum made of silicone, a connecting pipe, a catheter and a tube lock; the puncture septum is pressed and sleeved on the puncture side of the liquid storage cavity of the port body, the puncture surface of the puncture septum faces the top surface of the port body, and protrudes out of the top surface of the port body to form a circular hill top; and a titanium inner shell made of titanium metal, the titanium inner shell is provided with an open side for receiving the penetration of a non-destructive needle, and a connecting edge extending outward is provided on the open side; the connecting edge is pressed between the base of the port body and the back side of the puncture septum away from the puncture surface, the shape of the titanium inner shell fits the inner wall of the liquid storage cavity of the port body, and forms a puncture-proof cavity for storing and infusing liquid; one end of the connecting pipe is sleeved in the liquid outlet of the port body, and the other end is sleeved in the catheter to form an infusion channel; the tube lock buckle is sleeved outside the connecting pipe and the catheter, and is used to lock the port body, the connecting pipe and The connection of the catheter; and a three-way valve, the three-way valve is composed of an integrally formed substrate and a valve wall, the valve wall stands on the substrate, and forms a triangular structure in cross section; the inner angle of the valve wall on both sides in the cross section is 86 degrees; the three-way valve sealing sleeve is arranged in the liquid outlet, and is arranged in a fastening manner by pressing the pipe mouth of the connecting pipe fitting into the substrate; a cutout is provided at one end of the valve wall away from the substrate, and the valve wall and the cutout point from the liquid outlet of the port body to the connecting pipe fitting; the valve wall controls the deformation of the cutout to prevent blood from flowing back to the puncture-proof cavity when normally closed, opens forward to output the medicine when the puncture-proof cavity is under positive pressure, opens reversely to draw in liquid when additional negative pressure is applied to the puncture-proof cavity, and the valve wall deforms inward to offset the negative pressure when the puncture-proof cavity is under passive negative pressure at the moment of needle withdrawal; the titanium inner shell is provided with an inner shell through hole arranged corresponding to the liquid outlet of the port body, and a filter membrane is installed on the inner shell through hole.

[0012] In one embodiment, a deformation reinforcement rib is provided outside the valve wall of the three-way valve, one end of the deformation reinforcement rib is arranged adjacent to the end face of the incision, the length path of the deformation reinforcement rib is arranged along the cross-sectional length direction of the valve wall, and the deformation reinforcement rib is arranged in the middle and upper part of the cross-sectional length direction of the valve wall; when the anti-puncture chamber is under passive negative pressure, the deformation reinforcement rib guides the deformation path of the valve wall to make the valve wall deform and contract inward to offset the passive negative pressure in the anti-puncture chamber at the moment of needle withdrawal, thereby preventing blood from being sucked back into the catheter to form a thrombus, and guiding the deformation path of the end face of the incision to promote the inward buckling of the wall surface of the incision, thereby increasing the closing force and closing deformation of the incision and resisting the influx of excessive blood pressure or body fluid pressure.

[0013] In one of the embodiments, the length of the deformation reinforcement rib is smaller than the cross-sectional length of the valve wall, and the length midline of the deformation reinforcement rib is higher than the cross-sectional length midline of the valve wall.

[0014] In one of the embodiments, the three-way valve is made of an elastic silicone material with a hardness of 60A.

[0015] In one of the embodiments, a precipitation grid is provided on the bottom adjacent to the titanium inner shell, the peripheral wall of the precipitation grid is connected and fixed to the peripheral wall of the titanium inner shell, and the connection between the peripheral wall of the precipitation grid and the peripheral wall of the titanium inner shell is sealed, and the precipitation grid is used to isolate the impurities of the medicinal solution and the bottom sediment formed by puncture debris that are deposited on the bottom of the titanium inner shell, and the grid wall of the precipitation grid is used to reduce the vertical channel area of ​​the bottom sediment surging from bottom to top in the stab-proof cavity, thereby reducing the movement of the bottom sediment in the stab-proof cavity, and the grid wall of the precipitation grid is used to reduce the fluid impact when the stab-proof cavity is injected with liquid; uniformly distributed precipitation pits are provided on the bottom of the titanium inner shell.

[0016] In one embodiment, the distance between the side of the precipitation grid facing the bottom of the titanium inner shell and the bottom of the titanium inner shell is 1.5-2.0 mm.

[0017] In one of the embodiments, the mesh of the precipitation grid is provided with a hole eaves to prevent the outflow of sediment, and the hole eaves extend from the mesh toward the bottom of the titanium inner shell, and the hole eaves also extend obliquely toward the center of the hole; the cross-sectional structure of the mesh and the hole eaves is in the shape of a funnel structure, which is used to prevent the bottom sediment from being disturbed by the fluid and flowing back to the top of the precipitation grid when the liquid is injected or extracted from the puncture-proof cavity.

[0018] In one embodiment, the filter membrane at least filters out drug solution impurities and puncture debris larger than 0.2 μm, so that drug solution impurities and puncture debris brought into the puncture-proof cavity by an undamaged needle remain in the puncture-proof cavity.

[0019] In one embodiment, the titanium inner shell is inlaid with the base by injection molding.

[0020] In one embodiment, the port body is composed of an outer shell and a base, and the top and bottom surfaces of the outer shell are respectively provided with a first through hole and a second through hole; a stepped cavity is provided in the outer shell, and the base and the titanium inner shell are inserted into the cavity from the second through hole to form a sealed connection; a platform edge extending outward is provided on the side of the puncture partition opposite to the circular hill top, and the platform edge is pressed between the connecting edge and the step in the cavity to form a seal for the space between the titanium inner shell and the outer shell; the circular hill top extends out from the first through hole.

[0021] The beneficial effects of the present invention are as follows: Implantable drug delivery devices play a significant role in solving the technical problems of existing all-plastic and all-metal infusion ports, including: (1) Prevent puncture and scratches: The titanium inner shell is made of titanium metal to form a puncture-proof cavity in the liquid storage cavity of the port body, so that after the non-destructive needle is inserted into the puncture septum, the bottom of the puncture-proof cavity will not be punctured or scratched by the non-destructive needle. The presence of the titanium inner shell effectively avoids the fragility of the plastic bottom of the port body and reduces the risk of chips and potential infection caused by needle puncture or scratching the bottom of the liquid storage cavity of the implantable drug delivery device.

[0022] (2) Easy to locate after implantation: The top surface of the protruding port of the puncture septum is designed to form a round hill top, so that the implantable drug delivery device can easily form a bulge on the skin after being implanted in the body. When a needle is required to inject or extract liquid, it is easier to locate the position of the puncture septum, thereby reducing unnecessary injuries. This is different from the traditional infusion port, which is difficult to show its position on the skin surface after implantation, resulting in mispuncture or failure to find the position of the infusion port when a needle puncture is required, further improving the patient's safety.

[0023] (3) Effectively prevent drug impurities and cuttings from entering body fluids or tissues: When a non-destructive needle pierces the silicone of the puncture septum, silicone debris may be scratched out; when a non-destructive needle pierces the puncture-proof cavity, titanium metal debris may be scratched out, as well as impurities that may be contained in the injected liquid. Through the combination of the titanium inner shell and the filter membrane, when the non-destructive needle is used, it can effectively filter out drug impurities, cuttings or tiny particles that may be contained in the puncture-proof cavity; these impurities and puncture debris will be filtered and retained in the puncture-proof cavity to prevent them from entering the connecting pipes and catheters, thereby preventing these impurities from entering the patient's body fluids or tissues through the catheter, reducing the complications caused by drug contamination and blood reflux.

[0024] (4) Effective feedback on the position of non-destructive needle puncture: The titanium inner shell embedded in the base of the port body is made of metal and has a metallic texture and high hardness. When the operator punctures the puncture-proof cavity of the implantable drug delivery device, the non-destructive needle touches the bottom or wall of the titanium inner shell, which produces a metallic touch texture. This allows the operator to better and more easily locate the puncture depth or position of the non-destructive needle in the puncture-proof cavity, providing the operator with more accurate operational feedback, making the operator more confident when performing infusion or extraction, and performing the steps faster, reducing the patient's discomfort, improving the patient's treatment experience, and helping the patient's recovery.

[0025] (5) Preventing blood backflow and deposition: The structure of the three-way valve ensures good sealing during the drug infusion operation and when the implantable drug delivery device is in a silent state, preventing blood from flowing back into the anti-puncture cavity. In addition, when the incision of the three-way valve is normally closed, the deformation of the incision controlled by the valve wall effectively avoids the problem of blood backflow. In positive and negative pressure environments, the incision is controlled to open in the positive direction to output the drug when the anti-puncture cavity is under positive pressure, and in the reverse direction to draw in liquid when additional negative pressure is applied to the anti-puncture cavity. When the anti-puncture cavity is under passive negative pressure at the moment of needle withdrawal, the valve wall deforms inward to offset the negative pressure. The dynamic changes of the valve wall and the incision make the flow control of the drug and body fluid more precise, greatly increasing the working mode of the implantable drug delivery device and greatly improving the reliability of blood backflow and deposition.

[0026] (6) Improve MRI compatibility: The implantable drug delivery device only uses titanium metal for the titanium inner shell, rather than the entire device using an all-metal structure, which avoids the artifact problem caused by traditional all-metal infusion ports during MRI scans; the impact of titanium metal on imaging examinations is minimal, ensuring that patients can obtain clear imaging results when MRI examinations are required; in addition, because fewer titanium metal parts are used, the implantable drug delivery device of the present invention is also lower in cost than an all-titanium infusion port, thereby reducing the selling price while ensuring the use effect and alleviating the burden on patients.

[0027] (7) Lightweight and cost optimization: Although the titanium inner shell adds a certain amount of weight to the implantable drug delivery device, it is relatively light compared to the traditional all-metal infusion port. In addition, the durability and biocompatibility of titanium materials are high, reducing the maintenance and replacement costs caused by long-term use.

[0028] (8) Improved patient experience: Since the device effectively avoids the problems of traditional infusion ports such as "easy to be punctured, scratched, produce chips, heavy, high cost and affect imaging examinations", patients are less likely to suffer device damage or infection during use, and it is more comfortable and safer when worn for a long time. By optimizing materials and structures, patients can receive long-term drug infusions more safely and comfortably.

[0029] In summary, the implantable drug delivery device of the present invention not only improves the safety and durability of the device, but also effectively reduces medical risks and patient discomfort, and significantly improves clinical application effects and patient experience. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] In order to more clearly illustrate the technical solution of the present invention, the drawings required for use in the implementation mode will be briefly introduced below. Obviously, the drawings described below are only some implementation modes of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0031] Figure 1 is a schematic top view of the structure of the implantable drug delivery device according to the first embodiment of the present invention; Figure 2 is a schematic cross-sectional view of the implantable drug delivery device according to the first embodiment of the present invention; Figure 3 is a schematic cross-sectional view of the titanium inner shell of the first embodiment of the present invention; Figure 4 is a schematic cross-sectional view of a three-way valve according to a first embodiment of the present invention; Figure 5 1 is a schematic diagram of the isometric structure of a three-way valve according to a first embodiment of the present invention; Figure 6 1 is a schematic structural assembly diagram of the three-way valve of the first embodiment of the present invention during positive pressure infusion; Figure 7 It is a schematic structural assembly diagram of the three-way valve of the first embodiment of the present invention during negative pressure liquid extraction; Figure 8 This is a diagram showing the use of the positive pressure infusion of the non-invasive needle-implantable drug delivery device according to the first embodiment of the present invention; Fig. 9 is a schematic cross-sectional view of the titanium inner shell and the precipitation grid according to the second embodiment of the present invention; Fig.10 It is a partial enlarged structural schematic diagram of the sedimentation grid according to the third embodiment of the present invention.

[0032] The reference numerals are as follows: 1. Port body; 11. Shell; 111. First through hole; 112. Second through hole; 113. Suture hole; 12. Base; 121. Liquid outlet; 2. puncture septum; 21. puncture surface; 22. round hill top; 23. platform edge; 3. Connecting pipe fittings; 4. Catheter; 5. Pipe lock; 6. Titanium inner shell; 61. Open side; 62. Connecting edge; 63. Anti-stab cavity; 64. Inner shell through hole; 65. Filter membrane; 66. Precipitation pit; 71. Infusion channel; 72. Non-damaging needle; 8. three-way valve; 81. base plate; 82. valve wall; 821. cutout; 83. deformation reinforcement rib; 9. Sedimentation grid; 91. Mesh; 92. Perforated eaves. DETAILED DESCRIPTION

[0033] The technical solutions in the embodiments of the present invention will be described clearly and completely below in conjunction with the accompanying drawings in the embodiments of the present invention.

[0034] A specific embodiment provides an implantable drug delivery device, which effectively solves the technical problems of existing all-plastic infusion ports that are easily punctured, scratched or produce chips, and all-metal infusion ports that are heavy, costly and affect the accuracy of imaging examinations.

[0035] The first embodiment of the implantable drug delivery device is Figures 1 to 5 As shown, it comprises a port body 1 made of plastic, a puncture septum 2 made of silicone, a connecting pipe 3, a catheter 4 and a tube lock 5; the puncture septum 2 is pressed and inserted into and sleeved on the puncture side of the liquid storage cavity of the port body 1, the puncture surface 21 of the puncture septum 2 faces the top surface of the port body 1, and protrudes out of the top surface of the port body 1 to form a circular hill top 22; and a titanium inner shell 6 made of titanium metal, the titanium inner shell 6 is provided with an open side 61 for receiving the non-destructive needle 72 to penetrate, and an outwardly facing opening is provided on the open side 61 The connecting edge 62 is extended; the connecting edge 62 is pressed between the base 12 of the port body 1 and the back of the puncture septum 2 away from the puncture surface 21, and the shape of the titanium inner shell 6 fits the inner wall of the liquid storage cavity of the port body 1, and forms a puncture-proof cavity 63 for storing and infusing liquid; one end of the connecting pipe 3 is sleeved in the liquid outlet 121 of the port body 1, and the other end is sleeved in the catheter 4 to form an infusion channel 71; the tube lock 5 is buckled on the outside of the connecting pipe 3 and the catheter 4, and is used to lock the port body 1 and the connecting pipe 3. The connection between the pipe 3 and the conduit 4; and the three-way valve 8, which is composed of an integrally formed substrate 81 and a valve wall 82, the valve wall 82 standing on the substrate 81, forming a triangular structure in cross section; the sealing sleeve of the three-way valve 8 is arranged in the liquid outlet 121, and is arranged in a fastening manner by pressing the pipe opening of the connecting pipe 3 into the substrate 81; a notch 821 is provided at one end of the valve wall 82 away from the substrate 81, and the valve wall 82 and the notch 821 are connected from the liquid outlet 121 of the port body 1 1 points to the connecting pipe 3; the incision 821 is used to prevent blood from flowing back to the puncture-proof chamber 63 when it is normally closed, to open forward to output the liquid medicine when the puncture-proof chamber 63 is under positive pressure, to open reversely to draw in liquid when an additional negative pressure is applied to the puncture-proof chamber 63, and to deform and retract the valve wall 82 to offset the negative pressure when the puncture-proof chamber 63 is under passive negative pressure at the moment of needle withdrawal; the titanium inner shell 6 is provided with an inner shell through hole 64 arranged corresponding to the liquid outlet 121 of the port body 1, and a filter membrane 65 is installed on the inner shell through hole 64.

[0036] The puncture septum 2 is made of silicone material and has self-sealing properties, and can be punctured multiple times by the non-destructive needle 72 without leakage.

[0037] Among them, the filter membrane 65 at least filters out drug impurities and puncture debris larger than 0.2μm, so that the drug impurities and puncture debris brought into the puncture-proof cavity 63 by the undamaged needle 72 remain in the puncture-proof cavity 63, preventing the drug impurities and puncture debris from entering the connecting pipe 3 through the opened incision 821 and then entering the body fluid or tissue through the catheter 4.

[0038] In order to facilitate fixing the position of the implantable drug delivery device in the human body and prevent the implantable drug delivery device from moving or flipping in the body due to the patient's daily movements, thereby preventing safety problems; at least three suture holes 113 are evenly arranged on the sides of the shell 11 of the port body 1, which can be sutured with the subcutaneous tissue to prevent the port body 1 from flipping and ensure the safety of the human body after the drug delivery device is implanted.

[0039] The titanium inner shell 6 is inlaid with the base 12 by injection molding.

[0040] During application, the titanium inner shell 6 embedded in the base 12 of the port body 1 is made of metal and has a metallic texture and high hardness. When the operator punctures the puncture-proof cavity 63 of the implantable drug delivery device, the non-destructive needle 72 will produce a metallic touch texture when it touches the bottom or the surrounding wall of the titanium inner shell 6, which effectively feeds back the puncture position of the non-destructive needle 72, allowing the operator to better and more easily locate the puncture depth or position of the non-destructive needle 72 in the puncture-proof cavity 63, giving the operator more accurate operational feedback, allowing the operator to be more confident when performing infusion or extraction, and performing the steps faster, reducing the patient's discomfort, improving the patient's treatment experience, and contributing to the patient's recovery.

[0041] By adopting the structural design of the titanium inner shell 6 made of titanium metal, a puncture-proof cavity 63 is formed in the liquid storage cavity of the port body 1, so that after the non-damage needle 72 is inserted into the puncture septum 2, the bottom of the puncture-proof cavity 63 will not be pierced or scratched by the non-damage needle 72; the presence of the titanium inner shell 6 effectively avoids the fragility of the plastic bottom of the port body 1, and reduces the risk of chips and potential infection caused by the needle piercing or scratching the bottom of the liquid storage cavity of the implantable drug delivery device.

[0042] When the non-destructive needle 72 penetrates the silicone of the puncture septum 2, silicone debris may be scratched out; when the non-destructive needle 72 penetrates the puncture-proof cavity 63, titanium metal debris may be scratched out, as well as impurities that may be contained in the input liquid. Through the combination of the titanium inner shell 6 and the filter membrane 65, the non-destructive needle 72 can effectively filter out the drug liquid impurities, chips or tiny particles that may be contained in the puncture-proof cavity 63 when it is used; these impurities and puncture chips will be filtered and retained in the puncture-proof cavity 63 to prevent them from entering the connecting pipe 3 and the catheter 4, thereby preventing these impurities from entering the patient's body fluids or tissues through the catheter 4, effectively preventing the drug liquid impurities and chips from flowing out, and reducing the complications caused by drug contamination and blood reflux.

[0043] Moreover, in the implantable drug delivery device, only the titanium inner shell 6 is made of titanium metal, rather than the entire device being made of an all-metal structure, thereby avoiding the artifact problem that a traditional all-metal infusion port would produce during MRI scanning; the effect of titanium metal on imaging examinations is minimal, ensuring that patients can obtain clear imaging results when an MRI examination is required; in addition, because fewer titanium metal components are used, the implantable drug delivery device of the present invention is also lower in cost than an all-titanium infusion port, thereby reducing the selling price while ensuring the use effect and alleviating the burden on patients.

[0044] In addition, although the titanium inner shell 6 adds a certain amount of weight to the implantable drug delivery device, it is relatively light compared to the traditional all-metal infusion port; the titanium material has high durability and biocompatibility, which reduces the maintenance and replacement costs caused by long-term use; thereby achieving the effect of lightweighting and cost optimization of the traditional infusion port on the implantable drug delivery device.

[0045] As one optional implementation, Regarding the specific structure of the three-way valve 8 controlling the cutout 821, this embodiment is as follows: Figure 2 , Figure 4 and Figure 5 As shown, a deformation reinforcement rib 83 is provided outside the valve wall 82 of the three-way valve 8, one end of the deformation reinforcement rib 83 is arranged adjacent to the end face of the cutout 821, the length path of the deformation reinforcement rib 83 is arranged along the cross-sectional length direction of the valve wall 82, and the deformation reinforcement rib 83 is arranged in the middle and upper part of the cross-sectional length direction of the valve wall 82; and the inner angle of the valve walls 82 on both sides in the cross section is 86 degrees.

[0046] Specifically, when the anti-puncture chamber 63 is under passive negative pressure, the deformation reinforcement rib 83 guides the deformation path of the valve wall 82 to make the valve wall 82 deform inward and contract to offset the passive negative pressure in the anti-puncture chamber 63 at the moment of needle withdrawal, thereby preventing blood from being sucked back into the catheter 4 and forming a thrombus. The deformation path of the end face of the guiding incision 821 is used to promote the wall surface of the incision 821 to be buckled inward, thereby increasing the closing force and closing deformation of the incision 821 and resisting the influx of excessive blood pressure or body fluid pressure.

[0047] The substrate 81 is provided with a liquid receiving hole connected to the cavity surrounded by the valve wall 82 , so that the liquid receiving hole of the substrate 81 can be connected to the liquid outlet 121 of the port body 1 , and the cutout 821 on the valve wall 82 is connected to the infusion channel 71 .

[0048] When in use, the structure of the three-way valve 8 ensures good sealing during the drug infusion operation and when the implantable drug delivery device is in a silent state, preventing blood from flowing back into the puncture-proof chamber 63; in addition, when the incision 821 of the three-way valve 8 is normally closed, the valve wall 82 controls the deformation of the incision 821 to effectively avoid the problem of blood backflow; under positive and negative pressure environments, the incision 821 is controlled to open to achieve positive opening to output drug when the puncture-proof chamber 63 is under positive pressure, reverse opening to draw in liquid when additional negative pressure is applied to the puncture-proof chamber 63, and the valve wall 82 deforms inward to offset the negative pressure when the puncture-proof chamber 63 is under passive negative pressure at the moment of needle withdrawal. The dynamic changes of the valve wall 82 and the incision 821 make the flow control of drug and body fluids more precise, greatly increase the working mode of the implantable drug delivery device, and greatly improve the reliability of blood backflow and deposition.

[0049] Furthermore, in order to better control the valve wall 82 by the deformation reinforcement rib 83, a portion of one end of the deformation reinforcement rib 83 needs to be set in the lower middle part of the valve wall 82, and the remaining majority is set at a position close to the incision 821. The length of the deformation reinforcement rib 83 is smaller than the cross-sectional length of the valve wall 82, and the midline of the length of the deformation reinforcement rib 83 is higher than the midline of the cross-sectional length of the valve wall 82.

[0050] Furthermore, in order to realize the switching of the cutout 821 of the three-way valve 8 between various working states and to have durable performance, the material requirement of the three-way valve 8 is: made of elastic silicone material with a hardness of 60A.

[0051] Specifically, since the valve walls 82 on both sides form an angle of 86°, the valve wall 82 supports and closes the incision 821. Under different pressures, the incision 821 of the three-way valve 8 can be opened or closed in the positive and reverse directions; the deformation reinforcement ribs 83 can increase the opening pressure of the incision 821 and guide the deformation path of the valve wall 82 and the incision 821.

[0052] Under normal conditions, the incision 821 of the three-way valve 8 is in a closed state, which can prevent blood from flowing back and forming thrombus. Figure 4 and Figure 5 As shown; When a positive pressure of ≥10 kPa is applied to the puncture-proof cavity 63 through the dedicated non-destructive needle 72, the cutout 821 of the three-way valve 8 opens toward the infusion channel 71, and infusion can be performed. Figure 6 As shown; When a negative pressure of ≥30 kPa is applied to the anti-stab cavity 63 in the reverse direction, the incision 821 of the three-way valve 8 is reversely opened, and blood can be drawn. Figure 7 shown.

[0053] When the infusion is completed and the undamaged needle 72 is withdrawn, negative pressure will be formed in the anti-puncture cavity 63, and the three-way valve 8 will produce elastic deformation due to its own structure and material properties. The incision 821 of the three-way valve 8 is tightly closed, and the valve wall 82 is in a slightly deformed and retracted state under the support of the reinforcing ribs, which is used to offset the negative pressure in the anti-puncture cavity 63 and prevent blood from being sucked back into the catheter 4 to form a thrombus.

[0054] Regarding the combined structure of the port body 1, the puncture septum 2 and the titanium inner shell 6, this embodiment Figure 1 , Figure 2 and Figure 8 As shown, the port body 1 is composed of an outer shell 11 and a base 12, and the top and bottom surfaces of the outer shell 11 are respectively provided with a first through hole 111 and a second through hole 112; a stepped cavity is provided in the outer shell 11, and the base 12 and the titanium inner shell 6 are inserted into the cavity from the second through hole 112 and form a sealed connection; a platform edge 23 extending outward is provided on the opposite side of the puncture septum 2 away from the circular hill top 22, and the platform edge 23 is pressed between the connecting edge 62 and the step in the cavity to form a seal for the space between the titanium inner shell 6 and the outer shell 11; the circular hill top 22 extends from the first through hole 111.

[0055] During use, the structural design of the circular hill top 22 formed outside the top surface of the protruding port body 1 of the puncture septum 2 makes it easy for the implantable drug delivery device to form a bulge on the skin after being implanted in the body, making it easier to locate the position of the puncture septum 2 when a needle is required to inject or extract liquid, thereby reducing unnecessary damage; this is different from the traditional infusion port, which is difficult to show its position on the skin surface after being implanted in the body, making it difficult to distinguish the position of the infusion port when a needle puncture is required, and causing the possibility of mispuncture; the structure of the circular hill top 22 facilitates the positioning of the infusion needle after implantation, further improving the patient's safety.

[0056] A second embodiment of the implantable drug delivery device is Fig. 9 As shown, the difference between this embodiment and the first embodiment is that a precipitation grid 9 is arranged on the bottom adjacent to the titanium inner shell 6, the peripheral wall of the precipitation grid 9 is connected and fixed to the peripheral wall of the titanium inner shell 6, and the connection between the peripheral wall of the precipitation grid 9 and the peripheral wall of the titanium inner shell 6 is sealed; uniformly distributed precipitation pits 66 are arranged on the bottom of the titanium inner shell 6.

[0057] The optimal isolation distance between the side of the precipitation grid 9 facing the bottom of the titanium inner shell 6 and the bottom of the titanium inner shell 6 is 1.5-2.0 mm.

[0058] When in use, the sedimentation grid 9 is used to isolate the impurities of the medicinal solution and the bottom sediment formed by puncture debris that have settled to the bottom of the titanium inner shell 6. The grid wall of the sedimentation grid 9 reduces the vertical channel area of ​​the bottom sediment surging from bottom to top in the stab-proof cavity 63, thereby reducing the movement of the bottom sediment in the stab-proof cavity 63. The grid wall of the sedimentation grid 9 reduces the fluid impact when the liquid is injected into the stab-proof cavity 63.

[0059] A third embodiment of the implantable drug delivery device is Fig.10 As shown, the difference between this embodiment and the second embodiment is that the mesh 91 of the precipitation grid 9 is provided with a hole eaves 92 to prevent the outflow of sediment, the hole eaves 92 extend from the mesh 91 toward the bottom of the titanium inner shell 6, and the hole eaves 92 also extend obliquely toward the center of the hole; the cross-sectional structure of the mesh 91 and the hole eaves 92 is in the shape of a funnel structure.

[0060] When in use, the combined structure of the mesh 91 and the hole eaves 92 is used to reduce the upward passage area of ​​the bottom sediment, so that when the anti-puncture cavity 63 injects or extracts liquid, the fluid disturbance can be avoided to cause the bottom sediment to flow back to the top of the sedimentation grid 9, thereby reducing the filtering burden of the filter membrane 65.

[0061] The technical features of the above embodiments may be combined arbitrarily. To make the description concise, not all possible combinations of the technical features in the above embodiments are described.

Claims

1. An implantable drug delivery device, characterized in that: It comprises a port body made of plastic, a puncture septum made of silicone, a connecting pipe, a catheter and a pipe lock; the puncture septum is pressed and inserted and sleeved on the puncture side of the liquid storage cavity of the port body, the puncture surface of the puncture septum faces the top surface of the port body, and protrudes out of the top surface of the port body to form a circular hill top; and a titanium inner shell made of titanium metal, the titanium inner shell being provided with an open side for receiving the non-destructive needle to penetrate, and a connecting edge extending outwardly being provided on the open side; the connecting edge being pressed between the base of the port body and the back side of the puncture partition away from the puncture surface, the shape of the titanium inner shell being fitted to the inner wall of the liquid storage cavity of the port body, and forming a puncture-proof cavity for storing and infusing liquid; One end of the connecting pipe is sleeved in the liquid outlet of the port body, and the other end is sleeved in the catheter to form an infusion channel; the tube lock is sleeved outside the connecting pipe and the catheter to lock the connection between the port body, the connecting pipe and the catheter; and a three-way valve, the three-way valve being composed of an integrally formed substrate and a valve wall, the valve wall standing on the substrate to form a triangular structure in cross section; the three-way valve sealing sleeve being arranged in the liquid outlet, and being arranged in a fastening manner by pressing the liquid inlet of the connecting pipe fitting against the substrate; A cutout is provided at one end of the valve wall away from the substrate, and the valve wall and the cutout point from the liquid outlet of the port body to the connecting pipe; the valve wall controls the deformation of the cutout to prevent blood from flowing back into the puncture-proof chamber when it is normally closed, to open forward to output liquid when the puncture-proof chamber is under positive pressure, to open reversely to draw in liquid when additional negative pressure is applied to the puncture-proof chamber, and to deform inward to offset the negative pressure when the puncture-proof chamber is under passive negative pressure at the moment of needle withdrawal; The titanium inner shell is provided with an inner shell through hole which is arranged corresponding to the liquid outlet of the port body, and a filter membrane is installed on the inner shell through hole.

2. The implantable drug delivery device according to claim 1, characterized in that: A deformation reinforcement rib is arranged outside the valve wall of the three-way valve, one end of the deformation reinforcement rib is arranged adjacent to the end face of the cutout, the length path of the deformation reinforcement rib is arranged along the cross-sectional length direction of the valve wall, and the deformation reinforcement rib is arranged in the middle and upper part of the cross-sectional length direction of the valve wall; and the inner angle of the valve wall on both sides on the cross section is 86 degrees; When the puncture-proof cavity is under passive negative pressure, the deformation reinforcement rib guides the deformation path of the valve wall, so as to make the valve wall deform and contract inward to offset the passive negative pressure in the puncture-proof cavity at the moment of needle withdrawal, thereby preventing blood from being sucked back into the catheter to form a thrombus, and guiding the deformation path of the incision end face to promote the inward buckling of the incision wall surface, thereby increasing the closing force and closing deformation of the incision and resisting the influx of excessive blood pressure or body fluid pressure.

3. The implantable drug delivery device according to claim 2, characterized in that: The length of the deformation reinforcement rib is smaller than the cross-sectional length of the valve wall, and the length midline of the deformation reinforcement rib is higher than the cross-sectional length midline of the valve wall.

4. The implantable drug delivery device according to claim 1, characterized in that: The three-way valve is made of elastic silicone material with a hardness of 60A.

5. The implantable drug delivery device according to claim 1, characterized in that: A precipitation grid is arranged on the bottom adjacent to the titanium inner shell, the peripheral wall of the precipitation grid is connected and fixed to the peripheral wall of the titanium inner shell, and the connection between the peripheral wall of the precipitation grid and the peripheral wall of the titanium inner shell is sealed; The bottom of the titanium inner shell is provided with evenly distributed precipitation pits.

6. The implantable drug delivery device according to claim 5, characterized in that: The spacing between the side of the precipitation grid facing the bottom of the titanium inner shell and the bottom of the titanium inner shell is 1.5-2.0 mm.

7. The implantable drug delivery device according to claim 5, characterized in that: The mesh of the precipitation grid is provided with a hole eave to prevent the outflow of sediment, and the hole eave extends from the mesh toward the bottom of the titanium inner shell, and the hole eave extends obliquely toward the center of the hole at the same time; The cross-sectional structure of the mesh and the hole eaves is in a funnel shape.

8. The implantable drug delivery device according to claim 1, characterized in that: The filter membrane at least filters out drug solution impurities and puncture debris larger than 0.2 μm, so that the drug solution impurities and puncture debris brought into the puncture-proof cavity by an undamaged needle remain in the puncture-proof cavity.

9. The implantable drug delivery device according to claim 1, characterized in that: The titanium inner shell is inlaid with the base through injection molding.

10. The implantable drug delivery device according to claim 9, characterized in that: The port body is composed of a shell and the base, and the top surface and the bottom surface of the shell are respectively provided with a first through hole and a second through hole; A stepped cavity is provided in the outer shell, and the base and the titanium inner shell are inserted into the cavity from the second through hole to form a sealed connection; The puncture partition is provided with an outwardly extending platform edge on the side opposite to the circular hill top, and the platform edge is pressed between the connecting edge and the step in the cavity to form a seal for the space between the titanium inner shell and the outer shell; the circular hill top extends out from the first through hole.

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