A self-expanding non-destructive needle

Abstract

The embodiment of the present invention provides a self-expanding lossless needle, including a puncture needle and a first catheter connected to the puncture needle; the puncture needle includes a needle tip and a needle tube, the two ends of the needle tube are respectively connected to the needle tip and the first catheter, and a pre-expansion structure is provided at a position of the needle tube near the needle tip; the pre-expansion structure is in an expanded state when there is no external force, and the interior of the puncture needle is connected to the exterior of the puncture needle through the gap generated by the pre-expansion structure in the expanded state; the pre-expansion structure is in a non-expanded state when subjected to a radial force, the gap is closed, and the interior of the puncture needle is isolated from the exterior of the puncture needle. In this way, the passability of the puncture needle is improved, and the debris on the target object is reduced from entering the interior of the puncture needle, thereby improving the safety of the self-expanding lossless needle during infusion or extraction.

Description

Technical Field

[0001] The invention relates to the technical field of medical devices, and in particular to a self-expanding non-destructive needle. Background Art

[0002] Implantable drug delivery devices, also known as infusion ports, are infusion devices that are placed in the human body for a long time. Implantable drug delivery devices play an important role in treating patients who need chemotherapy, nutritional support, drainage of ascites or pleural effusion, pain management, blood collection, and other clinical needs that require repeated infusion or aspiration.

[0003] Generally, an implantable drug delivery device includes a port and a catheter. The catheter can be implanted in veins, arteries, peritoneum or spinal canal. The infusion needle pierces the seal on the port wall to infuse drugs or extract body fluids into the human body through the catheter. However, when the infusion needle pierces the seal on the port wall, puncture debris will appear, commonly known as "coring", which destroys the integrity of the seal and shortens the service life of the implantable drug delivery device during repeated infusion or aspiration treatment. In addition, the puncture debris may enter the human body along the catheter, which is less safe.

[0004] It can be seen that the existing infusion needles have the problem of low safety. Summary of the invention

[0005] The embodiment of the present invention provides a self-expanding non-destructive needle to solve the problem of low safety of infusion needles in the prior art.

[0006] The embodiment of the present invention provides a self-expanding non-destructive needle, comprising a puncture needle and a first catheter connected to the puncture needle; the puncture needle comprises a needle tip portion and a needle tube portion, two ends of the needle tube portion are respectively connected to the needle tip portion and the first catheter, and a pre-expansion structure is provided at a position of the needle tube portion close to the needle tip portion;

[0007] The pre-expanded structure is in an expanded state when no external force is applied, and the interior of the puncture needle is connected to the exterior of the puncture needle through a gap generated by the pre-expanded structure in the expanded state;

[0008] When the pre-expanded structure is subjected to a radial force, it is in a non-expanded state, the gap is closed, and the inside of the puncture needle is isolated from the outside of the puncture needle.

[0009] Optionally, the pre-expanded structure is a structure formed by cutting the tube wall of the needle tube along the axial direction of the needle tube, and then undergoing heat treatment and cooling to set the structure.

[0010] Optionally, at least two cutting lines are provided on the tube wall of the needle tube portion.

[0011] Optionally, four cutting lines are arranged on the tube wall of the needle tube part, and the four cutting lines are evenly distributed on the tube wall of the needle tube part.

[0012] Optionally, the needle tube portion includes a first section and a second section, the first section and the second section are arranged at a first angle, the pre-expansion structure is arranged in the first section, and the second section is partially nested in the first catheter.

[0013] Optionally, the first angle is 90 degrees.

[0014] Optionally, the needle tip is a solid structure without holes.

[0015] Optionally, the first catheter is provided with a needle handle, and the needle handle is used to fix the puncture needle when the puncture needle reaches the target position.

[0016] Optionally, the first catheter is further provided with a Luer connector, and the Luer connector is used to connect to an infusion device or a collection device.

[0017] Optionally, the material of the puncture needle is nickel-titanium alloy.

[0018] In this embodiment, a pre-expansion structure is provided on the puncture needle so that the pre-expansion structure is in an expanded state when no external force is applied, and is in a non-expanded state when subjected to a radial force; the interior of the puncture needle is connected to the exterior of the puncture needle through a gap generated by the pre-expansion structure in the expanded state, and during the process of the puncture needle puncturing the target object, the puncture needle is subjected to the radial force of the target object, so that the gap is closed, and the interior of the puncture needle is isolated from the exterior of the puncture needle, thereby improving the passability of the puncture needle and reducing the amount of debris on the target object entering the interior of the puncture needle, thereby improving the safety of the self-expanding non-destructive needle during infusion or extraction. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative labor.

[0020] Figure 1 is a schematic diagram of the structure of a self-expanding non-destructive needle provided by an embodiment of the present invention;

[0021] Figure 2 This is one of the schematic diagrams of the puncture process of the self-expanding non-destructive needle provided in an embodiment of the present invention;

[0022] Figure 3This is the second schematic diagram of the puncture process of the self-expanding non-destructive needle provided in an embodiment of the present invention;

[0023] Figure 4 This is the third schematic diagram of the puncture process of the self-expanding non-destructive needle provided in an embodiment of the present invention;

[0024] Figure 5 This is one of the structural schematic diagrams of the puncture needle of the self-expanding non-destructive needle provided in an embodiment of the present invention;

[0025] Figure 6 This is the second structural schematic diagram of the self-expanding non-destructive needle puncture needle provided in an embodiment of the present invention;

[0026] Figure 7 This is the third structural schematic diagram of the self-expanding non-destructive needle puncture needle provided in an embodiment of the present invention. DETAILED DESCRIPTION

[0027] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0028] The terms "first", "second", etc. in the specification and claims of the present invention are used to distinguish similar objects, and are not used to describe a specific order or sequence. It should be understood that the structures used in this way can be interchanged where appropriate, so that the embodiments of the present invention can be implemented in an order other than those illustrated or described herein, and the objects distinguished by "first", "second", etc. are generally of the same type, and the number of objects is not limited. For example, the first object can be one or more. In addition, "and / or" in the specification and claims represents at least one of the connected objects, and the character " / " generally indicates that the objects associated with each other are in an "or" relationship.

[0029] An implantable drug delivery device, also known as an infusion port, is an infusion device that is placed in the human body for a long time. Generally, an implantable drug delivery device includes a port body and a catheter. The catheter can be implanted in a vein, artery, intraperitoneum or spinal canal. The infusion needle pierces the seal on the wall of the port body and infuses drugs or draws body fluids into the human body through the catheter.

[0030] Usually the seal is made of silicone material. When the infusion needle pierces the seal on the port wall, part of the seal will enter the cutting edge of the infusion needle, resulting in puncture debris, commonly known as "coring", which destroys the integrity of the seal and shortens the service life of the implantable drug delivery device during repeated infusion or aspiration treatment. In addition, the puncture debris may enter the human body along the catheter, which has low safety.

[0031] To solve the above problems, the present invention provides a self-expanding non-destructive needle. Figure 1 , Figure 1 is a schematic diagram of the structure of a self-expanding non-destructive needle provided by an embodiment of the present invention. Figure 1 As shown, it includes a puncture needle 10 and a first catheter 20 connected to the puncture needle 10; the puncture needle 10 includes a needle tip 101 and a needle tube 102, and both ends of the needle tube 102 are connected to the needle tip 101 and the first catheter 20 respectively, and a pre-expansion structure 103 is provided at a position of the needle tube 102 close to the needle tip 101;

[0032] The pre-expanded structure 103 is in an expanded state when no external force is applied, and the interior of the puncture needle 10 is connected to the exterior of the puncture needle 10 through a gap 1031 generated by the pre-expanded structure 103 in the expanded state;

[0033] When the pre-expanded structure 103 is subjected to radial force, it is in a non-expanded state, the gap 1031 is closed, and the inside of the puncture needle 10 is isolated from the outside of the puncture needle 10 .

[0034] In this embodiment, by providing a pre-expansion structure 103 on the puncture needle 10, the pre-expansion structure 103 is in an expanded state when no external force is applied, and is in a non-expanded state when subjected to a radial force; the interior of the puncture needle 10 is connected to the exterior of the puncture needle 10 through a gap 1031 generated by the pre-expansion structure 103 in the expanded state. During the process of the puncture needle 10 puncturing the target object, the puncture needle 10 is subjected to the radial force of the target object, so that the gap 1031 is closed, and the interior of the puncture needle 10 is isolated from the exterior of the puncture needle 10, thereby improving the passability of the puncture needle 10 and reducing the amount of debris on the target object entering the interior of the puncture needle 10, thereby improving the safety of the self-expanding non-destructive needle during infusion or extraction.

[0035] Among them, the gap 1031 generated by the pre-expanded structure 103 in the expanded state is the infusion hole of the self-expanding lossless needle. The interior of the puncture needle 10 is connected to the outside of the puncture needle 10 through the gap 1031 generated by the pre-expanded structure 103 in the expanded state to realize the function of the infusion hole.

[0036] like Figures 1 to 4 As shown, the implantable drug delivery device includes a port body 30 and a second catheter 40. The target object may be a seal 301 on the port body 30. The seal 301 is generally made of silicone rubber material. A receiving cavity 302 is provided in the port body 30. The second catheter 40 is connected to the receiving cavity 302. The second catheter 40 may be implanted in a vein, an artery, the peritoneum or the spinal canal.

[0037] After the implantable drug delivery device is implanted in the human body, when the patient needs infusion or extraction, the drug delivery device or the extraction device is connected to the puncture needle 10 through the first catheter 20, and the puncture needle 10 is inserted into the sealing member 30 at the center position of the port body 30. During the insertion of the puncture needle 10, the radial force of the sealing member 30 drives the pre-expanded structure 103 on the puncture needle 10 to shrink. Figures 2 to 3 As shown, the pre-expanded structure 103 changes from the expanded state to the non-expanded state to close the gap 1031 generated by the pre-expanded structure 103 in the expanded state. When the pre-expanded structure 103 is completely placed in the sealing member 30, as shown in FIG. Figure 3 As shown, the puncture needle 10 is in a smooth and non-porous state to reduce the debris on the sealing member 30 from entering the interior of the puncture needle 10 during the puncture process;

[0038] After the pre-expanded structure 103 passes through the seal and enters the accommodating chamber 302, there is no external force restraining the pre-expanded structure 103. Figure 4 As shown, the expanded state is restored, the interior of the puncture needle 10 is connected to the exterior of the puncture needle 10 through the gap 1031 generated by the pre-expanded structure 103 in the expanded state, and the infusion liquid can enter the accommodating cavity 302 through the gap 1031 and be delivered to the human body through the second catheter 40;

[0039] After the infusion is completed, during the process of pulling out the puncture needle 10, the radial force of the seal 30 will drive the pre-expanded structure 103 on the puncture needle 10 to shrink to close the gap 1031. After the puncture needle 10 is pulled out, the pre-expanded structure 103 is not restrained by external force and returns to the expanded state. Therefore, the generation of debris can be reduced and the service life of the implantable drug delivery device can be increased.

[0040] Optionally, the pre-expanded structure 103 may be a structure formed by cutting the wall of the needle tube part 102 along the axial direction of the needle tube part 102 and then undergoing heat treatment and cooling to set the shape.

[0041] In this embodiment, laser cutting is performed along the axial direction of the needle tube part 102 at a position close to the needle tip part 101, so that a cutting edge is generated at the cutting position, and a high-temperature heat treatment and cooling and shaping process are performed at the position to form a pre-expanded structure 103, and the profile of the pre-expanded structure 103 is similar to a rugby ball;

[0042] Among them, at least two cutting lines are set on the tube wall of the needle tube part 102, and each cutting line is equal in length and equal in intervals to enhance the consistency of the gap 1031 formed after high-temperature heat treatment and cooling and shaping process, thereby improving the smoothness of the pre-expanded structure 103 after contraction.

[0043] Specifically, four cutting lines can be set on the tube wall of the needle tube part 102, and the four cutting lines are evenly distributed on the tube wall of the needle tube part 102, so that after the high-temperature heat treatment and cooling and shaping process, the pre-expanded structure 103 has four gaps 1031 without external force, such as Figure 1 and Figures 5 to 7 As shown, the four gaps 1031 are of equal size and are evenly distributed on the wall of the needle tube portion 102 . The interior of the puncture needle 10 is connected to the exterior of the puncture needle 10 through the four gaps 1031 generated by the pre-expansion structure 103 in the expanded state, so that the infusion solution flows out of the puncture needle 10 through the four gaps 1031 .

[0044] It should be noted that, according to the diameter of the needle tube part 102 and the thickness of the tube wall, other numbers of cutting lines can be set to form a corresponding number of gaps 1031, which can also achieve the same technical effect. To avoid repetition, it will not be repeated here.

[0045] Optionally, the needle tube portion 102 includes a first section and a second section, the first section and the second section are arranged at a first angle, the pre-expansion structure 103 is arranged in the first section, and the second section is partially nested in the first catheter 20 .

[0046] In this embodiment, during the insertion process of the puncture needle 10, the first section of the needle tube part 102 passes through the target object, and the second section of the needle tube part 102 is partially embedded in the first catheter 20 to connect the puncture needle 10 with the first catheter 20. After the first section of the needle tube part 102 passes through the target object and reaches the target position, the first section and the second section of the needle tube part 102 are arranged at a first angle to facilitate fixing the second section of the needle tube part 102 and the first catheter 20, thereby improving the stability during infusion or extraction through the self-expanding non-destructive needle.

[0047] Among them, the first angle can be 90 degrees, that is, the first section and the second section are arranged vertically. After the first section of the needle tube part 102 vertically passes through the target object to reach the target position, the second section of the needle tube part 102 and the first section are arranged at 90 degrees. The second section of the needle tube part 102 can be attached to the patient's body without the aid of other fixing devices, so as to improve the stability of the second section of the needle tube part 102 and the first catheter 20 when being fixed, thereby improving the safety of the self-expanding non-destructive needle during infusion or extraction.

[0048] The puncture needle 10 includes a needle tip portion 101 and a needle tube portion 102. The needle tip portion 101 can be described as follows: As an optional embodiment, the needle tip portion 101 can be a hollow structure, the needle tip wall of the needle tip portion 101 and the tube wall of the needle tube portion 102 have the same thickness, and the needle tip portion 101 and the needle tube portion 102 can be an integral structure so that the needle tip portion 101 and the needle tube portion 102 are smoothly connected.

[0049] As another optional embodiment, the needle tip portion 101 can be a solid structure without holes to enhance the penetration force of the needle tip portion 101 and improve the stability of the puncture needle 10 during puncture of the target object, and the needle tip portion 101 can be configured to be conical, and the connection between the needle tip portion 101 and the needle tube portion 102 has a smooth transition to reduce the occurrence of chips falling from the seal 30 during the puncture process.

[0050] Optionally, a needle handle 201 may be provided on the first catheter 20 , and the needle handle 201 is used to fix the puncture needle 10 when the puncture needle 10 reaches the target position.

[0051] In this embodiment, if Figures 1 to 4 As shown, a needle handle 201 is provided on the first catheter 20, and the needle handle 201 is in the shape of a butterfly wing. When the patient needs infusion or fluid extraction treatment, the medical staff can hold the needle handle 201 and aim the puncture needle 10 at the target object for puncture, so as to facilitate the self-expanding non-destructive needle;

[0052] After the puncture needle 10 passes through the target object and reaches the target position, the first catheter 20 can be attached to the patient's body. The needle handle 201 increases the contact area between the first catheter 20 and the patient's body, thereby enhancing the stability of the first catheter 20 when attached to the patient's body and reducing the occurrence of random movement of the first catheter 20, thereby improving the safety of infusion or extraction through the self-expanding non-destructive needle.

[0053] The first catheter 20 may also be provided with a Luer connector 202, which is used to connect to an infusion device or a collection device. The first catheter 20 is connected to the infusion device or the collection device via the Luer connector 202 to reduce leakage at the connection.

[0054] Optionally, the material of the puncture needle 10 can be nickel-titanium alloy. When the puncture needle 10 is subjected to high-temperature heat treatment and cooling and shaping, it has more plasticity, and the formed pre-expanded structure 103 is stable in an expanded state without external force; when subjected to radial force, it is in a non-expanded state, and the inside of the puncture needle 10 is isolated from the outside of the puncture needle 10, and the sealing property of the gap 1031 is better. Reduce the debris on the target object from entering the inside of the puncture needle 10, thereby improving the safety of the self-expanding non-destructive needle during infusion or extraction.

[0055] It should be noted that the material of the puncture needle 10 can also be other shape memory alloys, such as copper-zinc alloy, indium-titanium alloy, etc., which can also achieve the same technical effect. To avoid repetition, they will not be described here.

[0056] It should be noted that, in this article, the terms "include", "comprises" or any other variations thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or device. In the absence of further restrictions, an element defined by the sentence "comprises a ..." does not exclude the existence of other identical elements in the process, method, article or device including the element.

[0057] The embodiments of the present invention are described above in conjunction with the accompanying drawings, but the present invention is not limited to the above-mentioned specific implementation modes, which are merely illustrative rather than restrictive. Under the guidance of the present invention, ordinary technicians in this field can also make many forms without departing from the scope of protection of the present invention and the claims, all of which are within the protection of the present invention.

Claims

1. A self-expanding non-destructive needle, characterized in that: Applied to an implantable drug delivery device, the self-expanding non-destructive needle comprises a puncture needle and a first catheter connected to the puncture needle; the puncture needle comprises a needle tip and a needle tube, both ends of the needle tube are respectively connected to the needle tip and the first catheter, and a pre-expansion structure is provided at a position of the needle tube near the needle tip; The pre-expanded structure is in an expanded state when no external force is applied, and the interior of the puncture needle is connected to the exterior of the puncture needle through a gap generated by the pre-expanded structure in the expanded state; When the pre-expanded structure is subjected to a radial force, it is in a non-expanded state, the gap is closed, and the inside of the puncture needle is isolated from the outside of the puncture needle; The pre-expanded structure is a structure formed by cutting the tube wall of the needle tube along the axial direction of the needle tube, and then undergoing heat treatment and cooling to finalize the shape. The needle tip is a solid structure without holes.

2. The self-expanding non-destructive needle according to claim 1, characterized in that: At least two cutting lines are arranged on the tube wall of the needle tube part.

3. The self-expanding non-destructive needle according to claim 2, characterized in that: Four cutting lines are arranged on the tube wall of the needle tube part, and the four cutting lines are evenly distributed on the tube wall of the needle tube part.

4. The self-expanding non-destructive needle according to claim 1, characterized in that: The needle tube portion includes a first section and a second section, the first section and the second section are arranged at a first angle, the pre-expansion structure is arranged in the first section, and the second section is partially nested in the first catheter.

5. The self-expanding non-destructive needle according to claim 4, characterized in that: The first angle is 90 degrees.

6. The self-expanding non-destructive needle according to claim 1, characterized in that: The first catheter is provided with a needle handle, and the needle handle is used to fix the puncture needle when the puncture needle reaches the target position.

7. The self-expanding non-destructive needle according to claim 1, characterized in that: The first catheter is also provided with a Luer connector, and the Luer connector is used to connect an infusion device or a collection device.

8. The self-expanding non-destructive needle according to any one of claims 1 to 7, characterized in that: The material of the puncture needle is nickel-titanium alloy.

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