Drug-loaded biopsy puncture needle

Abstract

According to the technical scheme, the medicine-carrying biopsy puncture needle head is characterized by comprising a sleeve needle and a solid needle; the solid needle is arranged in the sleeve needle in a sliding manner; a tissue storage groove for storing tissues is formed in the solid needle; a microneedle array bearing medicine is detachably arranged at the needle point of the solid needle; the device has the advantages that biopsy puncture and local drug delivery can be combined, and the drug is directly delivered to a focus while target tissue of the focus is sampled.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and more particularly to a drug-loaded biopsy puncture needle. Background Art

[0002] Accurately determining the tumor type is of great reference value for formulating treatment plans. Histopathological examination is one of the effective methods for diagnosing and classifying malignant tumors, which usually requires obtaining target tissue samples from the corresponding parts.

[0003] Currently, there are two main methods for obtaining target tissue samples: surgery and puncture biopsy. Although surgery can provide highly complete tissue samples and reduce the error rate of pathological examinations, it is more traumatic and takes a long time to recover after surgery, and may be difficult to implement due to economic or physical conditions. In contrast, puncture biopsy confirms the sampling location through B-ultrasound or CT, and uses a biopsy puncture needle to obtain the target tissue along a predetermined path. It has the advantages of low cost, less trauma, fewer complications and faster healing, and has become the preferred sampling method in clinical practice. In actual operation, puncture biopsy may require multiple punctures to ensure the accuracy of the diagnosis, and frequent puncture sampling may promote the proliferation and spread of tumor cells in some cases.

[0004] Local drug delivery technology is a new drug delivery method. Compared with traditional systemic drug delivery methods such as intravenous injection or oral administration, it can directly deliver drugs to the target site. While reducing the amount of drugs used, it can also achieve higher drug concentrations in the lesion area and improve the therapeutic effect. In addition, since the drug acts directly on the lesion, it also reduces the damage caused to healthy tissues by the drug circulating in the body. Compared with other local drug delivery technologies, microneedle drug delivery technology can deliver a wide variety of drugs, and can achieve sustained and controlled release of drugs, with more stable and controllable dosages. However, microneedle drug delivery technology is usually applied to the skin. After the drug is absorbed by the skin, it reaches the lesion through the human blood circulation. In this process, it may cause drug loss and damage to other healthy tissues, and it is impossible to achieve direct delivery to certain organs inside the human body.

[0005] Therefore, how to combine biopsy puncture with local drug administration to achieve sampling of target lesion tissue and direct drug delivery to the lesion has become a technical problem that needs to be solved urgently by technicians in this field. Summary of the invention

[0006] In view of the deficiencies in the prior art, the object of the present invention is to provide a drug-loaded biopsy puncture needle to solve the above technical problems.

[0007] The above technical objectives of the present invention are achieved through the following technical solutions: a drug-loaded biopsy puncture needle, comprising: a sleeve needle and a solid needle; the solid needle is slidably arranged in the sleeve needle; a tissue storage groove for storing tissue is opened on the solid needle; a microneedle array carrying the drug is detachably arranged at the needle tip of the solid needle.

[0008] Among them, the microneedle array carries drugs, including cytotoxic drugs such as cisplatin, paclitaxel, gemcitabine, or various drugs that reduce tumor angiogenesis and enhance human immunity, such as bevacizumab, apatinib, anlotinib, pembrolizumab, and carrelizumab.

[0009] Specifically, the sleeve needle is convenient for puncturing the target tissue. After the solid needle reaches the target tissue with the sleeve needle, the microneedle array carrying the drug is inserted into the target tissue. At this time, the drug on the microneedle array is directly released at the lesion, and the drug can be directly delivered to the inside of the lesion without the need for blood circulation in the body. Therefore, compared with traditional injection administration, it not only reduces the use of drugs, but also reduces the damage to healthy cells caused by the delivery of drugs in the body.

[0010] Among them, the microneedle array can dissolve in the body, and the appropriate soluble carrier and matching drug can be selected according to the organs where the lesions are located. Generally speaking, the appropriate drug is selected according to the patient's condition, and the soluble carrier with similar dissolution efficiency is selected according to the release rate and dosage required for the drug. The drug and the soluble carrier are mixed to form a microneedle array, so that the microneedle array can be released to the lesion at a prescribed rate and dosage after piercing the target tissue, thereby ensuring the continuity and stability of the treatment effect.

[0011] During operation, first install the microneedle array on the solid needle, and then put the solid needle into the sleeve needle to form a puncture needle; puncture the puncture needle into the lesion, and use B-ultrasound or CT to guide the sleeve needle to the target tissue position. After reaching the target tissue position, push the solid needle so that the microneedle array on the solid needle pierces the target tissue. At this time, the tissue storage tank is in the target tissue and outside the sleeve needle. Then the sleeve needle is inserted into the target tissue, and part of the target tissue is cut off and stored in the tissue storage tank through the shearing action between the inner wall of the sleeve needle and the tissue storage tank. Finally, the microneedle array is separated from the solid needle, so that it remains at the lesion target tissue, and the puncture needle is pulled out of the human body, so that the lesion target tissue can be sampled while the drug is directly delivered to the lesion.

[0012] Optionally, a first guide block is arranged in the sleeve needle; and a first guide groove corresponding to the first guide block is opened on the solid needle.

[0013] By providing the first guide block and the first guide groove, the solid needle can be guided when it moves in the sleeve needle. The first guide block and the first guide groove can limit the position of the solid needle, thereby limiting the position of the tissue storage slot, and improving the stability of sampling. Specifically, the first guide groove is a through groove, and when the microneedle array is separated from the solid needle, the sleeve needle is pushed so that the first guide block partially extends out of the first guide groove, contacts with the back of the microneedle array, and pushes the microneedle array to separate from the solid needle.

[0014] Optionally, the cross-section of the first guide block is square, triangular, wedge-shaped or arc-shaped.

[0015] The cross-sections of the first guide block and the first guide groove are set to be square, triangular, wedge-shaped or arc-shaped, so that the first guide block can slide in the first guide groove while limiting the radial rotation of the solid needle.

[0016] Optionally, a second guide block is further provided in the sleeve needle; and a second guide groove corresponding to the second guide block is provided on the solid needle.

[0017] The position of the solid needle can be further limited by the second guide block and the second guide groove.

[0018] Optionally, a protective cover is provided on the microneedle array; and a receiving groove for receiving the protective cover is provided on the sleeve needle.

[0019] Installing a protective cover on the microneedle array can prevent tissue debris from entering the sleeve needle during the puncture process and damaging the microneedle array, ensuring the therapeutic effect of the drug on the microneedle array. After the puncture needle reaches the target tissue position, the sleeve needle is pushed forward a short distance. At this time, the second guide block is separated from the second guide groove and contacts the rear end of the protective cover. The protective cover falls off the microneedle array under the push of the second guide block and falls into the storage groove, and the subsequent drug delivery and sampling work can be carried out.

[0020] Optionally, the receiving groove is a circular groove with a radius of 0.3 to 0.7 mm and a depth of 0.1 to 0.2 mm.

[0021] The diameter and depth of the storage groove are slightly larger than the size of the protective cover, and since the thickness of the sleeve needle is limited, a suitable size needs to be designed to accommodate the protective cover without affecting the puncture.

[0022] Optionally, the microneedle array includes: a back-symmetric layer, and a plurality of microneedle heads; the plurality of microneedle heads are evenly arranged on the back-symmetric layer; a microneedle array storage groove is opened at the needle head of the solid needle; the back-symmetric layer and the microneedle array storage groove are detachably connected.

[0023] Among them, several microneedles carry drugs. After the puncture needle reaches the target tissue, the solid needle is pushed to make several microneedles pierce the target tissue, and then the sleeve needle moves forward, so that the first guide block part extends out of the first guide groove and contacts the back-symmetric layer. The back-symmetric layer is separated from the microneedle array storage groove under the push of the first guide block, and the drug can be retained in the target tissue of the lesion and slowly released.

[0024] Optionally, the back surface layer is in the shape of a disk with a radius of 0.3 to 0.7 mm; and the microneedle head is in the shape of a cone with a height of 80 to 180 μm and a bottom diameter of 30 to 80 μm.

[0025] The size of the back-symmetric layer is compatible with the needle head size of the solid needle, and it is not easy to fall off naturally from the microneedle array storage groove.

[0026] Optionally, the microneedle array is any one of a polyvinyl alcohol microneedle array, a polylactic acid microneedle array, a hyaluronic acid microneedle array, a chitosan microneedle array, a polylactic acid-glycolic acid copolymer microneedle array or a silk protein microneedle array.

[0027] Since the microneedle array needs to slowly release drugs at the target tissue of the lesion, the microneedle array needs to be made of materials that can dissolve in the human body and are not easy to react with drugs. And because different lesions use different drugs, the release rate and release dose of the drugs are also different. The appropriate dissolution efficiency of the material and the type of drug carried can be selected so that the drug can be released to the lesion at the prescribed rate and dose, achieving a continuous and stable treatment effect.

[0028] Optionally, the sleeve needle is any one of a conical needle, a Fuxin needle, a single-bevel conical needle, a hypodermic injection needle or a Cournan needle.

[0029] The sleeve needle needs to be easy to puncture into the target tissue, and a certain amount of space needs to be left inside for the solid needle to enter and exit and perform cutting.

[0030] In summary, the present invention has the following beneficial effects:

[0031] 1) Combine the sleeve needle with the solid needle, use the outer sleeve needle for puncture, and use the inner solid needle for sampling and drug delivery, and deliver the drug directly to the lesion while sampling the target tissue of the lesion;

[0032] 2) Using soluble microneedle arrays as drug delivery carriers, the drugs are delivered directly to the lesions, reducing the damage to healthy tissues caused by drug circulation in the body and improving the bioavailability of drugs. After the drug delivery is completed, the microneedle array can be self-degraded in the body, reducing the generation of medical waste.

[0033] 3) The microneedle array can select appropriate materials and drugs according to the organs where the lesions are located to control the dissolution and drug delivery process so that the drugs can be released to the lesions at a prescribed rate and dosage, thereby improving the treatment effect and reducing harm to healthy human tissues. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Figure 1 is a schematic cross-sectional structural diagram of the sleeve needle in the present invention;

[0035] Figure 2 is a schematic diagram of the axial cross-sectional structure of the solid needle of the present invention;

[0036] Figure 3 is a schematic diagram of the radial cross-sectional structure of the solid needle of the present invention;

[0037] Figure 4 is a schematic diagram of the structure of the microneedle array of the present invention;

[0038] Figure 5 It is a schematic diagram of the tissue state when the sleeve needle and the solid needle of the present invention are assembled;

[0039] Figure 6 It is a schematic cross-sectional view of the assembled sleeve needle and solid needle of the present invention;

[0040] Figure 7 yes Figure 6 A is an enlarged schematic diagram.

[0041] In the figure: 1. sleeve needle; 2. solid needle; 3. tissue storage tank; 4. microneedle array; 51. back-symmetric layer; 42. microneedle head; 5. first guide block; 6. first guide groove; 7. second guide block; 8. second guide groove; 9. protective cover; 10. storage groove; 11. microneedle array storage tank. DETAILED DESCRIPTION

[0042] In order to make the purpose, features and advantages of the present invention more obvious and easy to understand, the specific implementation methods of the present invention are described in detail below in conjunction with the accompanying drawings. Several embodiments of the present invention are shown in the accompanying drawings. However, the present invention can be implemented in many different forms and is not limited to the embodiments described herein.

[0043] In the present invention, unless otherwise clearly specified and limited, the terms "installed", "connected", "connected", "fixed" and the like should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal connection of two elements. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to the specific circumstances. The terms "first" and "second" are used for descriptive purposes only and cannot be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features defined as "first" and "second" may explicitly or implicitly include one or more of the features.

[0044] The present invention is described in detail below in conjunction with the accompanying drawings and embodiments.

[0045] Embodiment 1

[0046] This embodiment provides a drug-loaded biopsy puncture needle for liver puncture, such as Figure 1-7 As shown, it includes: a sleeve needle 1 and a solid needle 2; the solid needle 2 is slidably arranged in the sleeve needle 1; a tissue storage groove 3 for storing tissue is opened on the solid needle 2; a microneedle array 4 carrying a drug is detachably arranged at the needle tip of the solid needle 2.

[0047] Optional, such as Figure 1-3 As shown, a first guide block 5 is arranged in the sleeve needle 1 ; and a first guide groove 6 corresponding to and matching the first guide block 5 is opened on the solid needle 2 .

[0048] Optionally, the cross section of the first guide block 5 is square, triangular, wedge-shaped or arc-shaped. In this embodiment, a square shape is selected.

[0049] Optional, such as Figure 5 and Figure 7 As shown, a protective cover 9 is provided on the microneedle array 4 ; and a receiving groove 10 for receiving the protective cover 9 is provided on the sleeve needle 1 .

[0050] Optional, such as Figure 1 , Figure 2 , Figure 6 and Figure 7 As shown, a second guide block 7 is further provided in the sleeve needle 1 ; and a second guide groove 8 corresponding to and matching the second guide block 7 is provided on the solid needle 2 .

[0051] Optionally, the receiving groove 10 is a circular groove with a radius of 0.3-0.7 mm and a depth of 0.1-0.2 mm. In this embodiment, the receiving groove 10 has a radius of 0.3 mm and a depth of 0.1 mm.

[0052] Optional, such as Figure 2 and Figure 4 As shown, the microneedle array 4 includes: a back-symmetric layer 51, and a plurality of microneedle heads 42; the plurality of microneedle heads 42 are evenly arranged on the back-symmetric layer 51; a microneedle array storage groove 11 is opened at the needle head of the solid needle 2; the back-symmetric layer 51 and the microneedle array storage groove 11 are detachably connected.

[0053] Optionally, the back-symmetric layer 51 is in the shape of a disk with a radius of 0.3-0.7 mm; the microneedle head 42 is in the shape of a cone with a height of 80-180 μm and a bottom diameter of 30-80 μm. In this embodiment, the back-symmetric layer 51 has a radius of 0.3 mm, the microneedle head 42 has a height of 80 μm, and a bottom diameter of 30 μm.

[0054] Optionally, the microneedle array 4 is any one of a polyvinyl alcohol microneedle array, a polylactic acid microneedle array, a hyaluronic acid microneedle array, a chitosan microneedle array, a polylactic-co-glycolic acid microneedle array or a silk protein microneedle array. The microneedle array 4 of this embodiment uses a sodium hyaluronate microneedle array, and the drugs carried thereon are various liver disease drugs.

[0055] Optionally, the sleeve needle 1 is any one of an inverted tapered needle, a Fuxin needle, a single-bevel tapered needle, a hypodermic needle or a Cournan needle. The sleeve needle 1 of this embodiment is a single-bevel tapered needle.

[0056] When performing a biopsy on a patient, the prepared microneedle array 4 made of sodium hyaluronate and carrying the corresponding liver disease drug is attached to the microneedle array storage slot 11 on the top of the solid needle 2, and covered with a protective cover 9. Then adjust the position of the solid needle 2 so that the first guide groove 6 on the solid needle 2 and the first guide block 5 on the sleeve needle 1 are interlocked; the second guide groove 8 on the solid needle 2 and the second guide block 7 on the sleeve needle 1 are interlocked; at this time, the solid needle 2 and the sleeve needle 1 form a combination needle with the sleeve needle 1 outside and the solid needle 2 inside. The combination needle is installed on a puncture needle kit of appropriate size, and the biopsy puncture is ready to start.

[0057] The patient is made to lie on his back, and after local anesthesia, a small incision is made on the skin at the predetermined puncture point, and the combination needle is pushed into the liver at a predetermined position according to a predetermined trajectory under ultrasound guidance. The sleeve needle 1 first penetrates forward for a short distance, at which time the second guide block 7 is disengaged from the second guide groove 8, and the protective cover 9 is pushed down into the protective cover 9 storage groove, so that the microneedle array 4 is completely exposed. Then the solid needle 2 is pushed to make the microneedle head 42 penetrate into the liver tissue, and the sleeve needle 1 is then inserted, and the first guide block 5 moves along the first guide groove 6 and pushes the microneedle array 4 to disengage from the microneedle array storage groove 11, at which time the microneedle array 4 is retained in the liver tissue and slowly releases the drug. In addition, during the insertion of the sleeve needle 1, the tissue storage groove 3 on the solid needle 2 contacts the liver tissue, and under the action of the inner wall of the sleeve needle 1 and the opening of the tissue storage groove 3, the liver component is cut, so that a certain amount of liver tissue samples are retained in the tissue storage groove 3. After completing the above steps, the combination needle is quickly pulled out, and the sampling of the target tissue of the lesion can be completed while the drug is directly delivered to the lesion.

[0058] Embodiment 2

[0059] The present embodiment discloses a drug-loaded biopsy puncture needle for lung puncture, comprising: a sleeve needle 1 and a solid needle 2; the solid needle 2 is slidably arranged in the sleeve needle 1; a tissue storage groove 3 for storing tissue is opened on the solid needle 2; a microneedle array 4 is detachably arranged at the needle tip of the solid needle 2.

[0060] Optionally, a first guide block 5 is provided in the sleeve needle 1 ; and a first guide groove 6 corresponding to and matching the first guide block 5 is provided on the solid needle 2 .

[0061] Optionally, the cross section of the first guide block 5 is square, triangular, wedge-shaped or arc-shaped. In this embodiment, a wedge-shaped one is selected.

[0062] Optionally, a protective cover 9 is provided on the microneedle array 4 ; and a receiving groove 10 for receiving the protective cover 9 is provided on the sleeve needle 1 .

[0063] Optionally, a second guide block 7 is further provided in the sleeve needle 1 ; and a second guide groove 8 corresponding to and matching the second guide block 7 is opened on the solid needle 2 .

[0064] Optionally, the receiving groove 10 is a circular groove with a radius of 0.3-0.7 mm and a depth of 0.1-0.2 mm. In this embodiment, the receiving groove 10 has a radius of 0.7 mm and a depth of 0.2 mm.

[0065] Optionally, the microneedle array 4 includes: a back-symmetric layer 51, and a plurality of microneedle heads 42; the plurality of microneedle heads 42 are evenly arranged on the back-symmetric layer 51; a microneedle array storage groove 11 is opened at the needle head of the solid needle 2; the back-symmetric layer 51 and the microneedle array storage groove 11 are detachably connected.

[0066] Optionally, the back-symmetric layer 51 is in the shape of a disk with a radius of 0.3-0.7 mm; the microneedle head 42 is in the shape of a cone with a height of 80-180 μm and a bottom diameter of 30-80 μm. In this embodiment, the back-symmetric layer 51 has a radius of 0.7 mm, the microneedle head 42 has a height of 180 μm, and a bottom diameter of 80 μm.

[0067] Optionally, the microneedle array 4 is any one of a polyvinyl alcohol microneedle array, a polylactic acid microneedle array, a hyaluronic acid microneedle array, a chitosan microneedle array, a polylactic acid-co-glycolic acid microneedle array or a silk protein microneedle array. The microneedle array 4 of this embodiment uses a sodium hydroxymethylcellulose microneedle array, and the drugs carried thereon are various anti-tumor or anti-tuberculosis drugs.

[0068] Optionally, the sleeve needle 1 is any one of an inverted tapered needle, a Fuxin needle, a single-bevel tapered needle, a hypodermic needle or a Cournan needle. The sleeve needle 1 of this embodiment is an inverted tapered needle.

[0069] When performing a biopsy on a patient, the prepared microneedle array 4 made of sodium hydroxymethylcellulose and carrying the corresponding anti-tumor or anti-tuberculosis drugs is attached to the microneedle array storage slot 11 on the top of the solid needle 2, and covered with a protective cover 9. Then adjust the position of the solid needle 2 so that the first guide groove 6 on the solid needle 2 and the first guide block 5 on the sleeve needle 1 are interlocked; the second guide groove 8 on the solid needle 2 and the second guide block 7 on the sleeve needle 1 are interlocked; at this time, the solid needle 2 and the sleeve needle 1 form a combination needle with the sleeve needle 1 outside and the solid needle 2 inside. The combination needle is installed on a puncture needle kit of appropriate size, and the biopsy puncture is ready to start.

[0070] The patient is made to lie on his back, and after local anesthesia, a small incision is made on the skin at the predetermined puncture point. Under the guidance of CT, the combined needle is pushed into the designated position of the lung according to the predetermined trajectory, and the patient is reminded to hold his breath during this process. The sleeve needle 1 first penetrates forward for a short distance, at which time the second guide block 7 is separated from the second guide groove 8, and the protective cover 9 is pushed down into the protective cover 9 storage groove, so that the microneedle array 4 is completely exposed. Then the solid needle 2 is pushed to make the microneedle head 42 penetrate into the lung tissue, and the sleeve needle 1 is then inserted, and the first guide block 5 moves along the first guide groove 6 and pushes the microneedle array 4 to make it separate from the microneedle array storage groove 11. At this time, the microneedle array 4 is retained in the lung tissue and slowly releases the drug. In the process of the sleeve needle 1 being inserted, the tissue storage groove 3 on the solid needle 2 contacts the lung tissue, and under the action of the inner wall of the sleeve needle 1 and the opening of the tissue storage groove 3, the lung component is cut, so that a certain amount of lung tissue samples are retained in the tissue storage groove 3. After completing the above steps, the combined needle is quickly pulled out to complete the sampling of the target tissue of the lesion and deliver the drug directly to the lesion at the same time.

[0071] Embodiment 3

[0072] The present embodiment discloses a drug-loaded biopsy puncture needle for pancreatic puncture, comprising: a sleeve needle 1 and a solid needle 2; the solid needle 2 is slidably arranged in the sleeve needle 1; a tissue storage groove 3 for storing tissue is opened on the solid needle 2; a microneedle array 4 is detachably arranged at the needle tip of the solid needle 2.

[0073] Optionally, a first guide block 5 is provided in the sleeve needle 1 ; and a first guide groove 6 corresponding to and matching the first guide block 5 is provided on the solid needle 2 .

[0074] Optionally, the cross section of the first guide block 5 is square, inverted triangle, wedge or arc. In this embodiment, a wedge is selected.

[0075] Optionally, a protective cover 9 is provided on the microneedle array 4 ; and a receiving groove 10 for receiving the protective cover 9 is provided on the sleeve needle 1 .

[0076] Optionally, a second guide block 7 is further provided in the sleeve needle 1 ; and a second guide groove 8 corresponding to and matching the second guide block 7 is opened on the solid needle 2 .

[0077] Optionally, the receiving groove 10 is a circular groove with a radius of 0.3-0.7 mm and a depth of 0.1-0.2 mm. In this embodiment, the receiving groove 10 has a radius of 0.5 mm and a depth of 0.15 mm.

[0078] Optionally, the microneedle array 4 includes: a back-symmetric layer 51, and a plurality of microneedle heads 42; the plurality of microneedle heads 42 are evenly arranged on the back-symmetric layer 51; a microneedle array storage groove 11 is opened at the needle head of the solid needle 2; the back-symmetric layer 51 and the microneedle array storage groove 11 are detachably connected.

[0079] Optionally, the back-symmetric layer 51 is in the shape of a disk with a radius of 0.3-0.7 mm; the microneedle head 42 is in the shape of a cone with a height of 80-180 μm and a bottom diameter of 30-80 μm. In this embodiment, the back-symmetric layer 51 has a radius of 0.5 mm, the microneedle head 42 has a height of 130 μm, and a bottom diameter of 55 μm.

[0080] Optionally, the microneedle array 4 is any one of a polyvinyl alcohol microneedle array, a polylactic acid microneedle array, a hyaluronic acid microneedle array, a chitosan microneedle array, a polylactic acid-co-glycolic acid microneedle array or a silk protein microneedle array. The microneedle array 4 of this embodiment uses a polyvinyl alcohol microneedle array 4, and the drugs carried thereon are various anti-tumor drugs.

[0081] Optionally, the sleeve needle 1 is any one of an inverted tapered needle, a Fuxin needle, a single-bevel tapered needle, a hypodermic needle or a Cournan needle. The sleeve needle 1 of this embodiment is a Cournan needle.

[0082] When performing a biopsy on a patient, the prepared microneedle array 4 made of polyvinyl alcohol and carrying the corresponding anti-tumor drug is attached to the microneedle array storage slot 11 on the top of the solid needle 2, and covered with a protective cover 9. Then adjust the position of the solid needle 2 so that the first guide groove 6 on the solid needle 2 and the first guide block 5 on the sleeve needle 1 are interlocked; the second guide groove 8 on the solid needle 2 and the second guide block 7 on the sleeve needle 1 are interlocked; at this time, the solid needle 2 and the sleeve needle 1 form a combination needle with the sleeve needle 1 outside and the solid needle 2 inside. The combination needle is installed on a puncture needle kit of appropriate size, and the biopsy puncture is ready to start.

[0083] The patient is made to lie on his back, and after local anesthesia, a small incision is made in the skin at the predetermined puncture point. Under the guidance of CT, the combined needle is pushed into the designated position of the pancreas according to the predetermined trajectory. The sleeve needle 1 first penetrates forward a short distance, at which time the second guide block 7 disengages from the second guide groove 8, and pushes the protective cover 9 into the protective cover 9 storage groove, so that the microneedle array 4 is completely exposed. Then the solid needle 2 is pushed to make the microneedle head 42 penetrate into the pancreatic tissue, and the sleeve needle 1 is then inserted, and the first guide block 5 moves along the first guide groove 6 and pushes the microneedle array 4 to disengage from the microneedle array storage groove 11. At this time, the microneedle array 4 is retained in the pancreatic tissue and slowly releases the drug. In the process of the sleeve needle 1 being inserted, the tissue storage groove 3 on the solid needle 2 contacts the pancreatic tissue, and under the action of the inner wall of the sleeve needle 1 and the opening of the tissue storage groove 3, the pancreatic component is cut, so that a certain amount of pancreatic tissue samples are retained in the tissue storage groove 3. After completing the above steps, the combined needle is quickly pulled out to complete the sampling of the target tissue of the lesion and deliver the drug directly to the lesion at the same time.

[0084] The drug-loaded biopsy puncture needle of the present invention combines a sleeve needle 1 with a solid needle 2. Puncture is performed by the outer sleeve needle 1, and sampling and drug delivery are performed by the inner solid needle 2. The drug is directly delivered to the lesion while sampling the target tissue of the lesion.

[0085] The above is only a preferred embodiment of the present invention, and the protection scope of the present invention is not limited to the above embodiments. All technical solutions under the concept of the present invention belong to the protection scope of the present invention. It should be pointed out that for ordinary technicians in this technical field, some improvements and modifications without departing from the principle of the present invention should also be regarded as the protection scope of the present invention.

Claims

1. A drug-loaded biopsy puncture needle, characterized in that: include: A sleeve needle and a solid needle; the solid needle is slidably arranged in the sleeve needle; a tissue storage groove for storing tissue is opened on the solid needle; a microneedle array carrying medicine is detachably arranged at the needle tip of the solid needle.

2. The drug-loaded biopsy puncture needle according to claim 1, characterized in that: A first guide block is arranged in the sleeve needle; and a first guide groove corresponding to and matching the first guide block is opened on the solid needle.

3. A drug-loaded biopsy puncture needle according to claim 2, characterized in that: The cross section of the first guide block is square, triangular, wedge-shaped or arc-shaped.

4. The drug-loaded biopsy puncture needle according to claim 2, characterized in that: A second guide block is also arranged in the sleeve needle; and a second guide groove corresponding to and matching the second guide block is opened on the solid needle.

5. The drug-loaded biopsy puncture needle according to claim 4, characterized in that: A protective cover is arranged on the microneedle array; and a receiving groove for receiving the protective cover is opened on the sleeve needle.

6. The drug-loaded biopsy puncture needle according to claim 5, characterized in that: The receiving groove is a circular groove with a radius of 0.3-0.7 mm and a depth of 0.1-0.2 mm.

7. The drug-loaded biopsy puncture needle according to claim 1, characterized in that: The microneedle array comprises: a back-symmetric layer and a plurality of microneedle heads; the plurality of microneedle heads are evenly arranged on the back-symmetric layer; a microneedle array storage groove is provided at the needle head of the solid needle; the back-symmetric layer and the microneedle array storage groove are detachably connected.

8. The drug-loaded biopsy puncture needle according to claim 7, characterized in that: The back-symmetric layer is in the shape of a disk with a radius of 0.3-0.7 mm; the microneedle head is in the shape of a cone with a height of 80-180 μm and a bottom diameter of 30-80 μm.

9. The drug-loaded biopsy puncture needle according to claim 1, characterized in that: The microneedle array is any one of a polyvinyl alcohol microneedle array, a polylactic acid microneedle array, a hyaluronic acid microneedle array, a chitosan microneedle array, a polylactic acid-glycolic acid copolymer microneedle array or a silk protein microneedle array.

10. The drug-loaded biopsy puncture needle according to claim 1, characterized in that: The sleeve needle is any one of a tapered needle, a Fuxin needle, a single-bevel tapered needle, a hypodermic injection needle or a Cournan needle.

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