Port assembly

Abstract

The application discloses a port assembly, which comprises a port and a non-traumatic puncture needle, wherein the port comprises a port seat, a liquid storage cavity is arranged in the port seat, an injection seat is fixedly arranged at the top of the liquid storage cavity, the injection seat is coaxial with the liquid storage cavity, the lower surface of the injection seat is concave upward, the non-traumatic puncture needle comprises a needle tube and a bending part arranged at one end of the needle tube, and the height of the bending part is smaller than the distance between the bottom of the liquid storage cavity and the lower surface of the injection seat. The port assembly improves the sealing performance and the compression resistance of the port as a whole, and ensures that the non-traumatic puncture needle will not hook and scratch the injection seat to generate debris when the non-traumatic puncture needle is pulled out, thereby improving the safety performance of the port.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of medical devices, and in particular to a port assembly. BACKGROUND

[0002] The port is a completely implanted, implanted in the body of the infusion drug delivery system, also known as an implanted drug delivery device, including a central venous catheter, the catheter end connected to the injection seat, the whole device is completely implanted in the body, with long retention time, fewer complications and other characteristics. The catheter tip is located in the superior vena cava, which can quickly dilute the drug concentration, avoid stimulating and damaging the blood vessel wall, and allow the patient's daily life to be unrestricted after port implantation, improving the quality of life. In actual clinical practice, the puncture needle is used in cooperation with the port, and when the drug solution needs to be injected, the puncture needle is inserted into the injection seat to form a needle channel in the injection seat. The puncture needle passes through the needle channel to input the drug solution into the storage cavity in the port, and then the catheter inputs the drug solution into the patient's body.

[0003] The existing port injection seat is generally made of a certain elastic silicone material, and the injection seat and the port are usually fixed by ultrasonic welding or glue sealing. However, in order to ensure the sealing performance of the port, the injection seat needs to be compressed during assembly. If the assembly between the injection seat and the port seat is not tight enough, the compression resistance of the port is poor, the injection seat is easy to burst, and the safety performance is poor.

[0004] At the same time, in order to facilitate assembly, the port seat and the storage cavity in the prior art are usually combined in a split structure, and then ultrasonic welding or glue bonding is used to combine them into one body. This method is prone to leakage at the joint of the port body combination, which becomes a hidden danger for the safe use of the port in clinical practice.

[0005] The puncture needle is used for infusion drug delivery and is used in cooperation with the port base to input the drug solution into the patient's body through the puncture needle and the port to treat the patient's disease. In actual clinical practice, after the port is implanted in the subcutaneous tissue of the human body, the puncture area of the port injection seat cannot be directly observed due to the obstruction of the skin tissue, and can only be punctured by palpation. At the same time, the medical staff inserts the puncture needle through the injection seat into the storage cavity, and the needle tip touches the bottom of the storage cavity to determine that the puncture needle is in place. However, in order to prevent the needle tip from penetrating into the bottom of the storage cavity, the bottom of the storage cavity is usually made of a relatively hard material. When the needle tip is blocked by touching the bottom, the needle tip will appear to roll forward or backward, forming a forward hook or a backward hook. When the puncture needle needs to be replaced and removed, if the hook protrudes outside the needle tip, it will cut the injection seat, hook out the debris, and damage the injection seat. When encountering various changes in patient's constitution, implantation site, implantation depth, and puncture force, the size of the hook formed by the needle tip is different, and the degree of damage to the injection seat is also different. After the injection seat is damaged, a series of complications such as drug extravasation, puncture area tissue ulceration, and acceleration of catheter and port seat thrombosis may occur.

[0006] In order to reduce the chipping when the needle tip penetrates into the injection seat of the infusion port, a bending corner is arranged at the needle tip of the puncture needle, and a needle channel is formed in the injection seat after the puncture needle penetrates into the injection seat. In order to ensure the pressure resistance of the injection seat, the injection seat needs to reach a certain thickness. However, in order to improve the comfort, the overall thickness of the infusion port should not be too high, so the distance between the bottom of the injection seat and the bottom of the liquid storage cavity is short. When the puncture needle penetrates into the infusion port and the needle tip touches the bottom, the bending point of the bending section of the puncture needle is usually located in the needle channel, so that the inclined surface angle of the bending section extrudes the needle channel of the injection seat, resulting in a decrease in the sealing pressure resistance. When high-pressure contrast medium is injected, leakage along the needle channel occurs. SUMMARY

[0007] Therefore, in order to solve the above problems, the present application provides an infusion port assembly.

[0008] The present application is realized by the following technical solutions:

[0009] The infusion port assembly comprises an infusion port and a non-injury puncture needle, the infusion port comprises a port seat, a liquid storage cavity is arranged in the port seat, an injection seat is fixedly arranged at the top of the liquid storage cavity, the injection seat is coaxial with the liquid storage cavity, the lower surface of the injection seat is concave upward, the non-injury puncture needle comprises a needle tube and a bending part arranged at one end of the needle tube, the height of the bending part is less than the distance between the bottom of the liquid storage cavity and the lower surface of the injection seat.

[0010] Preferably, the included angle α between the axis of the bending part and the axis of the tube body is 12°±2°, the distal end of the bending part is provided with a needle tip, the needle tip comprises a first blade surface and two symmetrical second blade surfaces extending from the distal end of the first blade surface, and the second blade surfaces are concave arcs.

[0011] Preferably, the first blade surface is a chamfered surface, the inclination direction of the first blade surface is opposite to the bending direction of the bending part, the plane where the first blade surface is located is tangent to the axis of the bending part, and the included angle γ between the plane where the first blade surface is located and the axis of the bending part is 10°±2°.

[0012] Preferably, the two second blade surfaces intersect at the distal end, and a blade tip is formed at the intersection of the two second blade surfaces.

[0013] Preferably, the difference between the distance d1 between the highest point of the first blade surface and the axis of the needle tube and the distance d2 between the highest point of the blade tip and the axis of the needle tube is greater than or equal to the height of the blade tip.

[0014] Preferably, the blade angle β of the blade tip on the longitudinal section is 30°±2°.

[0015] Preferably, the upper surface of the injection seat is provided with a convex arc surface protruding upward, and the lower surface of the injection seat is a concave arc surface recessed upward, and the concave arc surface is coaxial with the convex arc surface.

[0016] Preferably, the convex arc surface and the concave arc surface have the same curvature, and the curvature is 0.1 rad-0.12 rad.

[0017] Preferably, the liquid storage cavity is a titanium alloy liquid storage cavity, and the liquid storage cavity and the port seat are integrally injection molded.

[0018] Preferably, the convex arc surface of the upper surface of the injection seat is provided with a ring-shaped mounting groove, and the top of the outer wall of the port seat is embedded in the ring-shaped mounting groove.

[0019] The beneficial effects of the technical scheme of the present application mainly include:

[0020] 1. The lower surface of the injection seat is recessed upward, forming an avoidance space at the top of the liquid storage cavity. At the same time, the bending part of the atraumatic puncture needle is low, so that when the atraumatic puncture needle penetrates into the liquid storage cavity and touches the bottom, the bending part will not stay in the injection seat to generate extrusion force on the needle channel, thereby improving the sealing performance of the infusion port.

[0021] 2. The upper surface of the injection seat is provided with a convex arc surface corresponding to the concave arc surface of the lower surface, which ensures the thickness of the injection seat and thus ensures the compression resistance of the injection seat. At the same time, the convex arc surface on the upper surface of the injection seat facilitates the search for the injection position after the infusion port is implanted into the patient's body.

[0022] 3. The port seat and the liquid storage cavity are integrally injection molded, and the port seat and the injection seat are press-fitted with the top of the outer wall of the port seat embedded in the ring-shaped mounting groove of the injection seat. Compared with the traditional fixing methods such as welding and gluing, the sealing performance and compression resistance of the infusion port as a whole are improved.

[0023] 4. The liquid storage cavity is made of titanium alloy material, which is light and hard, and is not easy to be pierced by the needle tip of the atraumatic puncture needle, thereby improving the service life of the infusion port. At the same time, the titanium alloy material can enhance the X-ray detection development effect.

[0024] 5. For the hook formed by the needle tip of the atraumatic puncture needle after touching the bottom, the bending part of the atraumatic puncture needle can help to avoid the rear hook at the needle tip, and the first blade surface and the second blade surface arranged in the direction opposite to the bending part can help to avoid the front hook at the needle tip, thereby ensuring that the hook formed in any direction by the needle tip will not scratch the injection seat and generate debris when the atraumatic puncture needle is pulled out, thereby improving the safety performance of the infusion port. BRIEF DESCRIPTION OF DRAWINGS

[0025] Figure 1 is a perspective view of the infusion port;

[0026] Figure 2 is a cross-sectional view of the infusion port assembly (at this time the no-injury puncture needle is punctured in);

[0027] Figure 3 is a cross-sectional view of the existing infusion port assembly (at this time the puncture needle is punctured in);

[0028] Figure 4 is an assembly state schematic view of the infusion port assembly (at this time the port seat is not pressed into the annular mounting groove);

[0029] Figure 5 is a state schematic view of the no-injury puncture needle and the existing puncture needle punctured into the infusion port at the same time;

[0030] Figure 6 is Figure 5 is an enlarged view of part A in FIG. 8;

[0031] Figure 7 is a partial cross-sectional enlarged view of the no-injury puncture needle;

[0032] Figure 8 is Figure 5 is a state schematic view of the no-injury puncture needle and the existing puncture needle in FIG. 8 forming a "rear hook" after touching the bottom;

[0033] Figure 9 is is Figure 5 is a state schematic view of the no-injury puncture needle and the existing puncture needle in FIG. 8 forming a "front hook" after touching the bottom;

[0034] Figure 10 is a cross-sectional view of the injection seat. DETAILED DESCRIPTION

[0035] In order to make the purpose, advantages and characteristics of the present application more clear and detailed, the following non-limiting description of the preferred embodiments will be used for illustration and explanation. The embodiments are only typical examples of the application of the technical solutions of the present application, and any technical solutions formed by equivalent replacement or equivalent transformation are within the scope of the present application.

[0036] It is declared at the same time that in the description of the scheme, it is necessary to explain that the directions or position relationships indicated by the terms "center", "upper", "lower", "left", "right", "front", "rear", "inner", "outer" and the like are the directions or position relationships based on the directions or position relationships shown in the drawings, and are only for the convenience of description and simplification of the description, and are not indicative or suggestive of the devices or elements indicated must have a particular direction, be constructed and operated in a particular direction, and therefore cannot be understood as a limitation on the present application.

[0037] In addition, the terms "first", "second", etc. in the present solution are only for descriptive purposes and cannot be understood as indicating or implying a ranking of importance, or implicitly indicating the number of technical features shown. Therefore, the features defined with "first", "second" can explicitly or implicitly include one or more of the features. In the present invention, the meaning of "multiple" is two or more, unless otherwise explicitly specified.

[0038] The present invention discloses a port assembly, such as Figure 1 、 Figure 2 shown, comprising a port and atraumatic puncture needle 4, the port comprising a port seat 1, a liquid storage cavity 2 is arranged in the port seat 1, a injection seat 3 is fixedly arranged at the top of the liquid storage cavity 2, and the injection seat 3 is coaxial with the liquid storage cavity 2, the lower surface of the injection seat 3 is concave upward, forming a space at the top of the liquid storage cavity 2, the atraumatic puncture needle 4 comprises a needle tube and a bending part 401 arranged at one end of the needle tube, the height of the bending part 401 is less than the distance between the bottom of the liquid storage cavity 2 and the lower surface of the injection seat 3, when the needle of the atraumatic puncture needle 4 touches the bottom of the liquid storage cavity 2, the bending part 401 is completely inserted into the space between the bottom of the liquid storage cavity 2 and the lower surface of the injection seat 3, and the needle tube of the atraumatic puncture needle 4 is in the needle channel and does not form additional extrusion on the inner wall of the needle channel, ensuring the sealing performance.

[0039] As shown in Figure 3 , it is an existing port assembly, the lower surface of the injection seat in the port is convex downward, at this time the height of the bending part of the puncture needle 40 is higher than the distance between the bottom of the liquid storage cavity and the lower surface of the injection seat, so when the puncture needle 40 is completely inserted into the port, the bending part stays in the injection seat, as shown in Figure 5 、 Figure 6 , the left side of the figure is the atraumatic puncture needle 4 in the present invention, and the right side is the existing puncture needle 40, both of which are inserted into the port in the present invention, Figure 6 , where a is the distance from the bending part 401 of the atraumatic puncture needle 4 to the bottom of the liquid storage cavity 2, b is the distance from the lower surface of the injection seat 3 to the bottom of the liquid storage cavity 2, and c is the distance from the bending part of the existing puncture needle 40 to the bottom of the liquid storage cavity 2, wherein c > b > a, the atraumatic puncture needle 4 and the existing puncture needle 40 form a needle channel in the injection seat after passing through the injection seat, respectively, the bending part of the existing puncture needle 40 stays in the needle channel, and the part of the blade top protruding outward extrudes the needle channel (indicated by the arrow in the figure), resulting in a decrease in the sealing pressure resistance, and in high-pressure infusion, the problem of leakage along the needle channel is prone to occur; and the height of the bending part 401 of the atraumatic puncture needle 4 in the present invention is less than the distance between the bottom of the liquid storage cavity 2 and the lower surface of the injection seat 3, so the bending part 401 of the atraumatic puncture needle 4 is completely inserted into the space between the bottom of the liquid storage cavity 2 and the lower surface of the injection seat 3, and does not extrude the needle channel during injection, so the sealing performance is high.

[0040] like Figure 7 As shown, the angle α between the axis of the bent portion and the axis of the tube body is 12°±2°. The end of the bent portion 401 is provided with a needle tip. The needle tip includes a first cutting surface 402 and two symmetrical second cutting surfaces 403 extending from the end of the first cutting surface 402. The second cutting surfaces 403 are concave arc-shaped and simultaneously concave inward towards the needle tip, making the needle tip narrow inward. The two second cutting surfaces 403 intersect at the end, forming a cutting tip 404 at the junction of the two second cutting surfaces 403, making the needle tip sharper and facilitating the rapid insertion of the non-traumatic puncture needle 4 into the injection seat 3.

[0041] The first cutting edge 402 is a beveled surface, and its inclination direction is opposite to the bending direction of the bent portion 401. The bending angle of the bent portion 401 is reduced in the direction of the needle tip. The plane where the first cutting edge 402 is located is tangent to the axis of the bent portion 401, and the included angle γ between the plane where the first cutting edge 402 is located and the axis of the bent portion 401 is 10°±2°. In one embodiment, the vertex of the second cutting edge 403 is at the same height as the tangency point between the plane where the first cutting edge 402 is located and the axis of the bent portion 401.

[0042] like Figure 7 , Figure 9 As shown, the difference between the distance d1 between the highest point 406 of the first cutting surface and the axis of the needle tube and the distance d2 between the highest point 404 of the cutting tip and the axis of the needle tube is greater than or equal to the height of the cutting tip 404. When the non-traumatic puncture needle 4 is withdrawn from the infusion port, the highest point protruding outward in the needle channel in the direction of the first cutting surface 402 is the highest point 406 of the first cutting surface. When the cutting tip 404 touches the bottom and bends in the direction of the first cutting surface 402, the distance between the highest point 406 of the first cutting surface and the axis of the needle tube is greater than or equal to the height of the cutting tip 404. The difference between the distance d1 of the line and the distance d2 between the highest point of the blade tip 404 and the axis of the needle tube is greater than or equal to the height of the blade tip 404. Since the maximum bending length of the blade tip 404 is its height, when the blade tip 404 touches the bottom and bends towards the cutting edge to form a "forward hook," the length of the hook formed by the bending of the blade tip 404 will not exceed the highest point 406 of the first cutting surface. When the non-damaging puncture needle 4 is withdrawn, the hook will not contact the inner wall of the needle path, and no debris will form. Figure 9 As shown, the existing puncture needle 40 located on the right side, when its needle tip touches the bottom and forms a "forward hook", the "forward hook" protrudes, and when the puncture needle 40 is pulled out of the injection seat 3, the "forward hook" will scrape against the inner wall of the needle channel and produce debris.

[0043] like Figure 8As shown, the distance between the bending point 405 of the bent portion 401 of the non-traumatic puncture needle 4 and the axis of the needle tube is also greater than or equal to the height of the blade tip 404. When the blade tip 404 touches the bottom and bends in the direction of the bending point 405, the "back hook" bending in the opposite direction of the blade edge will not exceed the bending point 405. Therefore, when the blade tip 404 touches the bottom and bends in the direction of the bending point 405, the "back hook" will not contact the inner wall of the needle channel when the non-traumatic puncture needle 4 is pulled out, and no debris will be formed. Similarly, when the bending distance of the bent portion of the existing puncture needle 40 is greater than the protruding length of the "back hook", the "back hook" will not contact the inner wall of the needle channel when the puncture needle 40 is pulled out, and no debris will be formed.

[0044] like Figure 7 As shown, the cutting angle β of the cutting tip 404 on the longitudinal section is 30°±2°. The size of the cutting angle of the cutting tip 404 on the longitudinal section represents the thickness of the cutting tip 404. When the cutting angle of the cutting tip 404 on the longitudinal section is too small, the overall thickness of the cutting tip 404 is relatively thin, and the length of the cutting tip 404 is relatively long. When the cutting tip 404 touches the bottom, it is easy to bend and form a hook. At the same time, the length of the hook is relatively long, and it is easy to contact the inner wall of the needle channel and form debris. When the cutting angle of the cutting tip 404 on the longitudinal section is too large, the thickness of the cutting tip 404 is relatively thick, and the cutting tip 404 is relatively blunt and not sharp enough, which is not conducive to puncture. When the cutting angle β of the cutting tip 404 on the longitudinal section is 30°±2°, the cutting tip 404 is not easy to form a hook when touching the bottom, while ensuring that the cutting tip 404 is relatively sharp, which is convenient for puncture and cutting.

[0045] like Figure 10 As shown, in one embodiment, the upper surface of the injection seat 3 is provided with an upwardly protruding convex arc surface 301, and the lower surface of the injection seat 3 is an upwardly concave arc surface 302, wherein the concave arc surface 302 and the convex arc surface 301 are coaxial.

[0046] The convex arc surface 301 has the same convex arc and the concave arc surface 302 has the same concave arc, which is 0.1 rad to 0.12 rad. When the convex arc of the convex arc surface 301 and the concave arc of the concave arc surface 302 are large, the convex height of the convex arc surface 301 is high, which increases the overall height of the infusion port and reduces the comfort of infusion port implantation. When the convex arc of the convex arc surface 301 and the concave arc of the concave arc surface 302 are small, the concave height of the concave arc surface 302 is low, and the height of the clearance space formed at the top of the reservoir 2 is low, which cannot avoid the non-traumatic puncture needle 4 at the relatively high position of the bend 401.

[0047] The liquid storage cavity 2 is a titanium alloy liquid storage cavity 2, the titanium alloy has the characteristics of light weight and high hardness, can prevent the non-injury puncture needle 4 from damaging the liquid storage cavity 2 when penetrating into the liquid storage cavity 2 and contacting the bottom of the liquid storage cavity 2, causing the liquid storage cavity 2 to leak due to excessive puncture force, and the titanium alloy material can also enhance the X-ray detection development effect, and the liquid storage cavity 2 and the port seat 1 are integrally injection molded, compared with the splicing structure, the compression resistance, liquid leakage prevention performance and safety performance of the infusion port structure integrally injection molded are higher, the liquid storage cavity 2 is a circular groove type with an open top, and the outer edge of the opening of the liquid storage cavity 2 is curved outwardly, and in the injection molding process of the port seat 1, the curved part of the outer periphery of the liquid storage cavity 2 extends into the inside of the port seat 1, further increasing the tightness and firmness of the assembly between the liquid storage cavity 2 and the port seat 1.

[0048] As shown in Figure 2 、 Figure 4 、 Figure 10 The outer periphery of the convex arc surface 301 of the upper surface of the injection seat 3 is coaxially provided with a ring-shaped mounting groove 303, the outer periphery of the ring-shaped mounting groove 303 is coaxially provided with a protruding limiting portion 304, the height of the limiting portion 304 is lower than the height of the convex arc surface 301, and the top of the outer wall of the port seat 1 is embedded in the ring-shaped mounting groove 303, specifically, the opening diameter of the top of the port seat 1 is equivalent to the overall diameter of the injection seat 3 after the injection of the port seat 1 and the liquid storage cavity 2 is completed, before the injection seat 3 is assembled, after the injection seat 3 is placed in the port seat 1 and the bottom of the injection seat 3 abuts against the positioning block, the port seat 1 is provided with a section of outer wall higher than the outer wall of the injection seat 3 at the outer periphery of the injection seat 3, after the position of the injection seat 3 is determined, the section of outer wall higher than the outer wall of the injection seat 3 is bent and press-fitted and embedded in the ring-shaped mounting groove 303 on the upper surface of the injection seat 3, after the press-fitting is completed, the bent part of the outer wall is wrapped around the outer periphery of the limiting portion 304, so that the port seat 1 and the injection seat 3 are tightly matched, improving the sealing and compression resistance of the infusion port.

[0049] The present application has various embodiments, and all technical solutions formed by equivalent transformation or equivalent transformation fall within the protection scope of the present application.

Claims

1. An infusion port assembly, characterized in that: The device includes an infusion port and a non-traumatic puncture needle. The infusion port includes a port seat with a reservoir within it. An injection seat is fixedly mounted on the top of the reservoir, and the injection seat is coaxial with the reservoir. The lower surface of the injection seat is concave upwards. The non-traumatic puncture needle includes a needle tube and a bent portion at one end of the needle tube. The height of the bent portion is less than the distance between the bottom of the reservoir and the lower surface of the injection seat. The angle α between the axis of the bent portion and the axis of the needle tube is 12°±2°. A needle tip is provided at the end of the bent portion. The needle tip includes a first cutting edge and a... Two symmetrical second cutting surfaces extend from the end of the first cutting surface, the second cutting surfaces being concave arc-shaped; the first cutting surface is a beveled surface, its inclination direction being opposite to the bending direction of the bent portion, the plane containing the first cutting surface being tangent to the axis of the bent portion, and the angle γ between the plane containing the first cutting surface and the axis of the bent portion being 10°±2°; the two second cutting surfaces intersect at the end, and a cutting tip is formed at the junction of the two second cutting surfaces; the difference between the distance d1 between the highest point of the first cutting surface and the axis of the needle tube and the distance d2 between the highest point of the cutting tip and the axis of the needle tube is greater than or equal to the height of the cutting tip.

2. The infusion port assembly according to claim 1, characterized in that: The cutting angle β of the cutting tip on the longitudinal section is 30°±2°.

3. The infusion port assembly according to claim 1, characterized in that: The upper surface of the injection seat is provided with an upwardly convex arc surface, and the lower surface of the injection seat is an upwardly concave arc surface, wherein the concave arc surface and the convex arc surface are coaxial.

4. The infusion port assembly according to claim 3, characterized in that: The convex and concave arc surfaces have the same radius, which is 0.1 rad to 0.12 rad.

5. The infusion port assembly according to claim 1, characterized in that: The liquid storage chamber is a titanium alloy liquid storage chamber, and the liquid storage chamber and the port base are integrally injection molded.

6. The infusion port assembly according to claim 3, characterized in that: The upper surface of the injection seat has a convex arc surface with an annular mounting groove around its outer periphery, and the top of the outer wall of the injection seat is bent and embedded in the annular mounting groove.

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