Safe infusion port

Abstract

The utility model discloses a safe infusion port, and belongs to the technical field of medical instruments. The defects that in the prior art, a traditional infusion port is low in flushing efficiency or not thorough in flushing before medicine injection, and the infusion port is prone to penetrating and being damaged when a non-damage needle is used for puncturing are overcome. A main body structure of the device comprises an injection seat, a buffer plate, a containment, an X-ray impermeable mark, a shell and a guide pipe connecting port, the injection seat and the containment are installed in an inner cavity of the shell, the upper edge of the injection seat and the shell are installed in a matched mode, the bottom face of the injection seat and the containment are installed in a matched mode, and the buffer plate is connected with the upper surface of the bottom of the containment. The X-ray impermeable mark is connected with the lower surface of the bottom of the containment, and the conduit connector is in interference fit with a conduit seat on the containment. The infusion apparatus is mainly used for implanting into a human body for infusion.

Description

Technical Field

[0001] The utility model belongs to the technical field of medical devices, and in particular relates to a safe infusion port. Background Art

[0002] The infusion port is a closed infusion system that is completely implanted in the human body. The system includes a catheter with the end of the catheter connected to the injection port. The system is completely buried in the body and has the characteristics of long retention time and few complications. Existing infusion port structures, such as the Chinese invention patent application with application publication number CN 110327512 A, disclose a novel infusion port structure and assembly method, including an upper cover, a lower cover, a diaphragm, and a connector. In the first step, the diaphragm is placed in the first inner cavity of the upper cover, and the lower cover with the connector is installed at the lower part of the upper cover, and the diaphragm is squeezed by the upper and lower covers. In the second step, the assembled infusion port is placed upside down on a welding tool, and the welding head of an ultrasonic welding machine is placed on the bottom of the infusion port. The vibration of the welding head generates heat, which melts the welding annular flange that is interference-fitted with the upper end of the outer periphery of the lower cover body. At this time, the lower cover is precisely embedded in the upper cover, and the upper and lower covers are welded and fixed. During ultrasonic welding, the small and initial contact area is first melted to complete the welding. Then, when the parts are embedded together, the melting continues along their vertical walls with a controlled contact surface, thereby obtaining a strong structure and an excellent sealing effect. In this solution, the upper and lower covers are welded into one piece by ultrasonic welding, which has high structural strength and good sealing. However, it has some disadvantages: the inner cavity has a regular structure, which is difficult to flush, and during the non-destructive needle puncture process, it is easy to penetrate the lower cover injection molded part, causing damage to the infusion port.

[0003] For example, the Chinese invention patent application publication number CN117883658 A discloses a safe infusion port with a pressure-resistant structure, which includes a port seat, a liquid storage cavity arranged in the port seat, and an injection seat arranged on the top of the liquid storage cavity. The injection seat includes a puncture part and a limiting part arranged on the periphery of the puncture part. A mounting groove is provided in the port seat, the top of the mounting groove is open, and the liquid storage cavity is provided in the mounting groove. An avoidance groove is provided at the bottom of the liquid storage cavity, and the avoidance groove is coaxial with the puncture part. This scheme forms an upper and lower interlocking structure between the injection seat and the port seat, thereby improving the pressure resistance of the injection seat. The avoidance groove at the bottom of the liquid storage cavity ensures that a section of avoidance space is provided corresponding to the center position of the liquid storage cavity and the injection seat with the largest rebound amount, thereby achieving the height required for non-destructive needle puncture and improving the safety performance of the infusion port. However, its shortcomings are as follows: the liquid storage cavity and the port seat are integrally injection molded, and burrs or glue overflow are easily generated at the junction during the process, which makes it easy for the non-destructive needle to be injected into the human body after puncture, and the inner cavity has a regular structure and is difficult to flush; and the bottom cavity is easily penetrated by the non-destructive needle, or the non-destructive needle tip easily touches the rigid liquid storage cavity, causing damage and curling. When the non-destructive needle is pulled out after curling, it will damage the injection seat. If the infusion port is not fixed, the non-destructive needle after curling will even cause the infusion port to flip when it is pulled out.

[0004] For example, Chinese invention patent application publication number CN 118370898 A discloses a ceramic infusion port with anti-displacement and anti-leakage features. This port utilizes ceramic 3D printing to form an integrally formed injection base, resulting in a complete and reliable structure. Compared to metal materials, the ceramic injection base offers greater strength, wear resistance, and biocompatibility. However, this port has drawbacks: the rigid, regular ceramic structure at the bottom of the port makes it difficult to flush and can easily damage or bend the needle tip during puncture, leading to the risk of damage to the injection base and port flipping during removal. Furthermore, after implantation, X-rays cannot be used to identify whether the ceramic port has flipped within the body.

[0005] In summary, the current structural design of some infusion ports does not take processability into consideration. Due to process problems, debris is easily generated at the junction of the integral injection molding and enters the human body. In addition, the inner cavity structure of the existing infusion port is a regular cylindrical shape. When flushing with a non-destructive needle, a pulsed method of flushing-stop-flush is required to generate turbulence to thoroughly flush the residual drugs in the infusion port. However, this method is inefficient and requires high operator operability. It is easy to flush incompletely, resulting in two incompatible drugs remaining and reacting, which poses serious clinical risks. In addition, when some infusion ports are punctured with a non-destructive needle, because the shell material is soft and unprotected, the steel non-destructive needle can easily penetrate the shell material, causing damage to the infusion port. However, if a rigid structural member is used to protect the shell or other hard materials are used to make the shell, the needle tip of the steel non-destructive needle can be easily damaged or bent, affecting its removal and subsequent use, and there is even a risk of causing the infusion port to flip after removal. Utility Model Content

[0006] The technical problem to be solved by the utility model is to overcome the deficiencies of the prior art and provide a safe infusion port.

[0007] In order to achieve the above purpose, the present invention adopts the following technical solutions:

[0008] A safe infusion port comprises an injection seat, a buffer sheet, a safety shell, an X-ray opaque marker, a shell and a catheter connection port. The injection seat and the safety shell are installed in the inner cavity of the shell, the upper edge of the injection seat is mounted in cooperation with the shell, the bottom surface of the injection seat is mounted in cooperation with the safety shell, the buffer sheet is connected to the bottom upper surface of the safety shell, the X-ray opaque marker is connected to the bottom lower surface of the safety shell, and the catheter connection port is installed with an interference fit with the catheter seat on the shell.

[0009] Preferably, the upper end of the safety shell is provided with a safety shell inclined surface and a safety shell plane, the safety shell inclined surface is interference fitted with the shell, and the safety shell plane is squeezed with the bottom surface of the injection seat to form an end face seal.

[0010] Preferably, the shell and the containment vessel are an integral injection-molded structure.

[0011] Preferably, the circumferential cross-section of the containment shell is arc-shaped, and there are more than one containment shell spoiler ribs evenly distributed circumferentially.

[0012] Preferably, the width of the spoiler rib of the safety shell is in the range of 0.2 mm to 5 mm, the height of the protrusion is in the range of 0.2 mm to 5 mm, and the axial length is in the range of 0.2 mm to 10 mm.

[0013] Preferably, the outer cylindrical surface of the catheter connection port is provided with one or more annular one-way barbs.

[0014] Preferably, the thickness of the buffer sheet is less than the height d from the center of the axis of the catheter connection port to the upper surface of the bottom of the containment shell, and greater than the height h of the needle tip of the intact needle.

[0015] Preferably, the upper surface of the injection seat is provided with a raised step for non-destructive needle puncture, and the upper edge of the injection seat is interference fit with the shell.

[0016] Preferably, the X-ray opaque marker is connected to the bottom lower surface of the containment vessel by welding or gluing.

[0017] Compared with the prior art, the beneficial effects of the present invention are:

[0018] 1. The safety shell is pressed into the shell with interference fit. The plane of the safety shell is not embedded in the shell, but the inclined surface of the safety shell is fitted with the shell with interference fit, and is subjected to circumferential extrusion to form a stable sealing structure. The plane of the safety shell is squeezed with the bottom surface of the injection seat to form an end face seal. The lower surface of the inclined surface of the safety shell fits with the shell, and the upper surface forms an inner buckle structure with the bottom surface of the injection seat to prevent the injection seat from shifting. In addition, a part of the inclined surface of the safety shell extends into the interior of the shell, so that the safety shell and the shell are fixed to each other, and there is no displacement when puncture force is applied;

[0019] 2. The containment shell and the shell are integrally injection molded or interference fit. Tiny debris generated at the junction of the inclined surface of the containment shell and the shell can be sealed by the bottom surface of the interference-fitted injection seat to prevent the debris from entering the human body, which improves processability and safety. In addition, the containment shell is made of titanium alloy or other metal materials with certain strength and rigidity, which can prevent the non-destructive needle from penetrating the infusion port shell during puncture.

[0020] 3. The circumferential cross-section of the containment is arc-shaped, and the containment spoiler ribs are evenly distributed. The inner cavity can be directly flushed with a non-destructive needle, eliminating the need for pulsed flushing. When the flushing fluid passes through the curved surface of the inner cavity and the containment spoiler ribs, turbulence is easily generated, effectively flushing the lumen and inner wall of the infusion port, avoiding drug residue and reducing clinical risks.

[0021] 4. A buffer sheet is assembled on the upper surface of the bottom of the containment shell. The hardness, elastic modulus and shear modulus of the buffer sheet are all lower than those of the commonly used materials of the non-destructive needle. When the non-destructive needle punctures, the needle tip first breaks through the injection seat and contacts the buffer sheet. The buffer sheet is locally subjected to pressure from the needle tip, and the material deforms around the needle tip, exerting a reaction force on the needle tip. If the needle tip continues to break through and contacts the containment shell, the reaction force increases. However, the buffer sheet material plastically deforms and wraps around the needle tip. The needle tip is subjected to circumferential squeezing and will not deform. During clinical use, there is an obvious breakthrough feeling after puncturing through the injection seat. At this time, the non-destructive needle continues to puncture downward, and the buffer sheet will have a reaction force. There will be resistance when puncturing, prompting the operator to pay attention to the puncture depth to prevent over-puncture. If the operator continues to puncture, the non-destructive needle tip penetrates the buffer sheet and contacts the containment shell. The reaction force suddenly increases, and the resistance when puncturing increases sharply, prompting the operator that the puncture depth has reached the limit. The operator should immediately stop puncturing to reduce the risk. This effectively prevents damage to the needle tip during non-destructive needle puncture and various risks caused by subsequent damage.

[0022] 5. The shape of the radiopaque marker is characterized by being able to clearly distinguish its front and back sides. The marker can be integrally injection molded or tightly assembled with the housing. The front and back sides of the radiopaque marker are fixed relative to the front and back sides of the port housing. When it is necessary to confirm whether the port has been flipped, the front and back sides of the radiopaque marker can be confirmed by non-invasive X-rays to confirm whether the port has been flipped.

[0023] In summary, the present invention solves the problems of low or incomplete flushing efficiency before drug injection in the infusion port, easy penetration and damage of the infusion port during puncture with a non-destructive needle, damage or bending of the needle tip due to contact with the rigid structure of the infusion port, affecting drug injection, and even causing the infusion port to flip over when the needle is pulled out without timely identification. The present invention has higher safety and better processability, simplifies the flushing process before injection, reduces the risk of incomplete flushing, prevents the non-destructive needle from penetrating the infusion port during puncture, and protects the non-destructive needle tip. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 It is an exploded view of the utility model;

[0025] Figure 2 This is the main view of the utility model;

[0026] Figure 3 It is a structural diagram of the utility model;

[0027] Figure 4 This is a cross-sectional view of the shell of the utility model before hot pressing;

[0028] Figure 5 This is a cross-sectional view of the shell of the utility model after hot pressing and final assembly;

[0029] Figure 6 This is the assembly diagram of the containment shell and the shell in the present utility model;

[0030] Figure 7 This is a half-section schematic diagram after puncture in the present invention;

[0031] Figure 8 This is a front view diagram of the utility model under X-ray;

[0032] Figure 9 This is a schematic diagram of the present invention after flipping under X-ray;

[0033] Figure 10 This is a partial cross-sectional view of the conduit connection port in the utility model.

[0034] In the figure: 1. Injection seat; 2. Buffer plate; 3. Safety shell; 4. X-ray opaque marker; 5. Shell; 6. Catheter connection port; 7. Non-damaging needle; 11. Upper edge; 12. Raised step; 31. Safety shell slope; 32. Safety shell plane; 33. Safety shell spoiler rib; 51. Catheter seat; 61. Annular one-way barb. DETAILED DESCRIPTION

[0035] The present invention will be further described below through specific embodiments in conjunction with the accompanying drawings.

[0036] Example 1:

[0037] like Figure 1-3 As shown, a safe infusion port includes an injection seat 1, a buffer sheet 2, a safety shell 3, an X-ray opaque marker 4, a shell 5 and a catheter connection port 6. The injection seat 1 and the safety shell 3 are installed in the inner cavity of the shell 5, the upper edge 11 of the injection seat 1 is installed in cooperation with the shell 5, the bottom surface of the injection seat 1 is installed in cooperation with the safety shell 3, the buffer sheet 2 is connected to the bottom upper surface of the safety shell 3, the X-ray opaque marker 4 is connected to the bottom lower surface of the safety shell 3 by welding or glue, and the catheter connection port 6 is installed with an interference fit with the catheter seat 51 on the shell 5.

[0038] Specifically, the shell 5 is made of polysulfone resin or other strong metal or polymer materials. The shell 5 is injection molded, and the front opening is cylindrical after injection molding, which is convenient for assembly with the injection seat 1. The cylindrical opening of the shell 5 is buckled inward through the hot pressing process to form an interference fit with the injection seat 1, forming a stable structure.

[0039] In this embodiment, the X-ray opaque marker 4 is made of a heavy metal element or alloy with high density, including but not limited to platinum, iridium, gold, tantalum, tungsten, barium, etc. The X-ray opaque marker 4 is assembled to the bottom surface of the containment vessel 3 by welding or gluing. Figure 8-9 As shown, the shape of the X-ray opaque marker 4 has features that can significantly distinguish its front and back sides, including but not limited to one or a string of letters, one or more asymmetric geometric figures or graphic combinations, one or more asymmetric numbers, etc. The X-ray opaque marker 4 can be integrally injection-molded or tightly assembled with the shell 5.

[0040] Example 2:

[0041] like Figure 6 As shown, a safe infusion port is different from Example 1 in that a safety shell slope 31 and a safety shell plane 32 are provided at the upper end of the safety shell 3, the safety shell slope 31 is interference fitted with the shell 5, and the safety shell plane 32 is squeezed with the bottom surface of the injection seat 1 to form an end face seal.

[0042] like Figure 4-5 As shown, the containment shell 3 is interference-pressed into the shell 5, and the plane 32 of the containment shell is not embedded in the shell 5. However, the inclined surface 31 of the containment shell is interference-fitted with the shell 5 and is subjected to circumferential extrusion to form a stable sealing structure. The containment shell 3 is composed of titanium alloy or other metal materials with a certain strength and rigidity. The plane 32 of the containment shell is squeezed with the bottom surface of the injection seat 1 to form an end face seal. The lower surface of the inclined surface 31 of the containment shell is in contact with the shell 5, and the upper surface forms an inward buckle structure with the bottom surface of the injection seat 1 to prevent the injection seat 1 from shifting. In addition, a portion of the inclined surface 31 of the containment shell extends into the interior of the shell 5, so that the containment shell 3 and the shell 5 are fixed to each other, and there is no displacement when the puncture force is applied.

[0043] Example 3:

[0044] A safety infusion port differs from Example 1 in that the housing 5 and the containment shell 3 are integrally injection-molded. Specifically, because the housing 5 and the containment shell 3 are integrally injection-molded, any burrs present during mold release at the inclined surface 31 of the containment shell can be manually removed. Alternatively, the injection seat 1 and the housing 5 can be extruded and sealed, reducing the risk of in vivo particulate contamination.

[0045] Example 4:

[0046] A safe infusion port differs from Example 1 or Example 2 in that the circumferential cross-section of the containment shell 3 is arc-shaped, and one or more safety shell spoiler ribs 33 are evenly distributed circumferentially. The width of the safety shell spoiler ribs 33 ranges from 0.2 mm to 5 mm, the height of the protrusion ranges from 0.2 mm to 5 mm, and the axial length ranges from 0.2 mm to 10 mm.

[0047] Furthermore, the outer cylindrical surface of the catheter connection port 6 is provided with one or more annular one-way barbs 61. The catheter connection port 6 is made of a strong metal or polymer, and is pressed into the catheter seat 51 of the housing 5 by interference fit. Figure 10 As shown, the assembly strength between the conduit connection port 6 and the housing 5 is enhanced, the relative position with the housing 5 is more stable after interference fit, and the sealing performance is also better.

[0048] like Figure 7 As shown, the thickness of the buffer sheet 2 is less than the height d from the center of the axis of the catheter connection port 6 to the upper surface of the bottom of the containment vessel 3, and greater than the height h of the tip of the intact needle 7. The thickness of the buffer sheet 2 ranges from 0.2 to 5 mm, and preferably ranges from 0.2 to 2 mm. Specifically, the buffer sheet 2 is tightly assembled with the upper surface of the bottom of the containment vessel 3. The buffer sheet 2 is made of metal or polymer material, and the front geometric shape is a complete circle or an incomplete cut circle. The hardness of the buffer sheet 2 is less than the hardness of the material of the intact needle 7, preferably less than 60 HRC. The buffer sheet 2 has an elastic modulus of less than 250 GPa and a shear modulus of less than 250 GPa. The material selected has an elastic modulus and shear modulus lower than those of the commonly used steel material of the intact needle 7, but has suitable strength, preferably an elastic modulus of less than 150 GPa and a shear modulus of less than 150 GPa.

[0049] In this embodiment, the buffer sheet 2 is made of an alloy material and can be assembled to the containment vessel 3 by welding, interference fit, or fastening with fasteners. Alternatively, the buffer sheet 2 can be made of a polymer material, preferably but not limited to silicone of suitable hardness, and can be assembled to the containment vessel 3 by other strong connection methods such as bonding, interference fit, or fastening with fasteners.

[0050] Furthermore, the upper surface of the injection seat 1 is provided with a raised step 12 for non-invasive needle 7 puncture, and the upper edge 11 of the injection seat 1 forms an interference fit with the housing 5. Specifically, the injection seat 1 is made of silicone or other polymer materials, and the raised step 12 is provided for non-invasive needle 7 puncture. The upper edge 11 of the injection seat 1 is interference-fitted with the housing 5. Due to the extrusion effect of the housing 5 after hot pressing, the upper edge 11 of the injection seat 1 forms an inclined surface, and the injection seat 1 is circumferentially sealed with the housing 5. In addition, the injection seat 1 and the containment shell 3 form the inner cavity of the infusion port. The bottom surface of the injection seat 1 is interference-fitted with the safety shell bevel 31 and the safety shell plane 32 of the containment shell 3 to prevent displacement during puncture and form an end-face seal.

Claims

1. A safety infusion port, characterized by: The invention comprises an injection seat (1), a buffer sheet (2), a safety shell (3), an X-ray-proof marker (4), a shell (5) and a catheter connection port (6), wherein the injection seat (1) and the safety shell (3) are installed in the inner cavity of the shell (5), the upper edge (11) of the injection seat (1) is installed in cooperation with the shell (5), the bottom surface of the injection seat (1) is installed in cooperation with the safety shell (3), the buffer sheet (2) is connected to the bottom upper surface of the safety shell (3), the X-ray-proof marker (4) is connected to the bottom lower surface of the safety shell (3), and the catheter connection port (6) is installed in an interference fit with the catheter seat (51) on the shell (5).

2. The safe infusion port according to claim 1, characterized in that: The upper end of the safety shell (3) is provided with a safety shell inclined surface (31) and a safety shell plane (32); the safety shell inclined surface (31) and the shell (5) are interference-fitted; the safety shell plane (32) and the bottom surface of the injection seat (1) are squeezed to form an end face seal.

3. The safe infusion port according to claim 1, characterized in that: The shell (5) and the containment shell (3) are an integral injection-molded structure.

4. The safe infusion port according to any one of claims 1 to 3, characterized in that: The containment shell (3) has an arc-shaped circumferential cross-section, and has more than one containment shell spoiler rib (33) evenly distributed circumferentially.

5. The safe infusion port according to claim 4, characterized in that: The safety shell spoiler rib (33) has a width ranging from 0.2 mm to 5 mm, a protrusion height ranging from 0.2 mm to 5 mm, and an axial length ranging from 0.2 mm to 10 mm.

6. The safe infusion port according to any one of claims 1 to 3, characterized in that: The outer cylindrical surface of the catheter connection port (6) is provided with one or more ring-shaped one-way barbs (61).

7. The safe infusion port according to any one of claims 1 to 3, characterized in that: The thickness of the buffer sheet (2) is less than the height d from the center of the axis of the catheter connection port (6) to the upper surface of the bottom of the containment shell (3), and is greater than the needle tip height h of the intact needle (7).

8. The safe infusion port according to any one of claims 1 to 3, characterized in that: The upper surface of the injection seat (1) is provided with a raised step (12) for puncture by a non-damaging needle (7), and the upper edge (11) of the injection seat (1) and the housing (5) are in interference fit.

9. The safe infusion port according to any one of claims 1 to 3, characterized in that: The X-ray-impermeable marker (4) is connected to the bottom lower surface of the containment vessel (3) by welding or gluing.

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