Puncture biopsy locator

Abstract

This invention discloses a puncture biopsy locator, relating to the field of medical device technology, comprising: an outer cutting needle, an inner needle, a controller, and a marking and positioning clip. The inner needle has a V-shaped groove penetrating both radially sides of the inner needle, and a limiting hole is formed in the V-shaped groove. A sliding member is provided at the bottom of the marking and positioning clip, and an insertion member is provided at the end of the sliding member away from the puncture end. The sliding member slides and engages with the inner wall of the V-shaped groove. The insertion member is inserted into the limiting hole. The marking and positioning clip has a V-shaped clamping opening that penetrates the insertion member downwards. There is a gap between the marking and positioning clip and the inner needle. The outer cutting needle pushes the sliding member through the gap, causing the insertion member to disengage from the limiting hole. This invention uses the outer cutting needle to push the insertion member out of the limiting hole, thereby clamping the marking and positioning clip in the tissue to achieve the positioning function. That is, a puncture biopsy can be completed in one operation using a puncture needle, while the marking and positioning clip is left in the tissue to achieve tumor localization.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a puncture biopsy locator. Background Technology

[0002] In recent years, with the advancement of comprehensive diagnosis and treatment of breast cancer in my country, breast surgery has entered an era of precision and individualization. How to follow the principle of minimizing damage and surgery to further improve treatment outcomes is a significant challenge currently facing breast surgery. For patients, the location of the tumor is one of the key factors related to the success or failure of surgery. Accurately locating the tumor before surgery is particularly important. The purpose of placing breast tissue markers at the center of the original tumor location is not only to mark the original tumor location and monitor changes in tumor size, but also to determine the tumor bed for pathological examination. Especially when the patient achieves complete remission (PCR) after treatment, the precise location of residual tumor lesions is an important guarantee for accurate pathological evaluation of efficacy.

[0003] Before chemotherapy, a biopsy is often performed using a puncture needle. The structure of a commonly used puncture needle mainly includes a controller, an inner needle, and a cutting outer needle. The outer needle is fitted over the inner needle, and the end of the inner needle has a groove to accommodate the tissue. During use, the inner and outer needles are inserted together into the target location. The controller controls the inner needle to extend from the cutting outer needle and then controls the outer needle to move forward to remove the tissue. The removed tissue is located in the groove. However, commonly used puncture needles can only perform biopsies of tumor tissue. Because they lack positioning components, they do not provide a positioning marker. For patients who need to undergo neoadjuvant chemotherapy first, they cannot effectively locate the center of the primary tumor, especially after the tumor shrinks or disappears completely in neoadjuvant chemotherapy patients, where there is no specific reference point. For patients undergoing resection of small tumor masses, it is necessary to reuse the biopsy delivery device to deliver tissue markers and complete the implantation of tissue markers. This not only subjects the patient to the pain of invasive procedures again, increases the risk of wound infection and tumor dissemination, and increases the patient's medical expenses, but also reduces the overall treatment efficiency.

[0004] Therefore, there is an urgent need for a puncture biopsy locator that has positioning capabilities, high safety, and high treatment efficiency. Summary of the Invention

[0005] The purpose of this invention is to provide a puncture biopsy locator to solve the problems existing in the prior art. It can simultaneously push out the marker positioning clip during puncture sampling, so that the puncture needle has a positioning function. It can complete puncture biopsy and tumor localization in one operation, thereby improving the efficiency and safety of the overall treatment.

[0006] To achieve the above objectives, the present invention provides the following solution: The present invention provides a biopsy locator, comprising an outer cutting needle with a cutting function at its end, an inner needle with a tissue groove at its puncture end, and a controller for controlling the movement of the outer cutting needle and the inner needle. The biopsy locator further comprises a marker positioning clip with an elastic self-recovery function. A V-shaped groove is formed on the inner needle, extending radially through both sides of the inner needle. A limiting hole is formed on the inner wall surface of the V-shaped groove away from the puncture end. A sliding member is provided at the bottom of the marker positioning clip, and a connector is provided at the end of the sliding member away from the puncture end. The surface of the sliding member near the puncture end forms an acute angle with the marker positioning clip. The sliding member is close to the V-shaped groove. The inner wall surface of the puncture end slides into contact with the insertion piece, which is inserted into the limiting hole. The marking and positioning clamp has a V-shaped clamping opening facing the puncture end. The V-shaped clamping opening penetrates downward through the sliding member and the insertion piece. The width of the limiting hole is the same as the width of the insertion piece when the V-shaped clamping opening is closed. The height of the limiting hole is greater than the thickness of the insertion piece. There is a gap between the marking and positioning clamp and the inner needle for the outer cutting needle to pass through. The sliding member is located on the movement path of the outer cutting needle. The outer cutting needle pushes the sliding member to disengage the insertion piece from the limiting hole. After disengagement, the opening length of the V-shaped clamping opening at the free end of the insertion piece is not less than the length of the chord line corresponding to the inner needle and the insertion piece.

[0007] Preferably, the slider, the connector, and the marking and positioning clip are integrally formed.

[0008] Preferably, the sliding member is connected to the end of the marking and positioning clip near the puncture end of the inner needle, and the connection between the sliding member and the marking and positioning clip is tapered.

[0009] Preferably, the marking positioning clip, the sliding member, and the plug-in member are made of pure titanium or titanium alloy.

[0010] Preferably, the marking positioning clip is plate-shaped, and the outer surface of the marking positioning clip is smooth.

[0011] Preferably, the inner walls on both sides of the V-shaped clamping opening are interlocking tooth-like structures.

[0012] Preferably, the end of the marker positioning clip away from the puncture end is provided with a pull hole, and a pull line for pulling and adjusting the position of the marker positioning clip outside the body is provided in the pull hole.

[0013] Preferably, the inner pin has a deceleration band on the outer surface of the marking positioning clamp to slow down the advancing speed of the cutting outer pin.

[0014] Preferably, the puncture end of the inner needle is detachably equipped with a blade.

[0015] Preferably, the V-groove and the limiting hole are directly disposed on the inner needle; or the inner needle is provided with an installation groove corresponding to the position of the marking positioning clip, a base is disposed in the installation groove, the inner sidewall of the installation groove near the puncture end is slidably engaged with the sliding member, and the limiting hole is disposed at one end of the base near the puncture end.

[0016] The present invention achieves the following main technical effects compared to the prior art:

[0017] During the process of tissue resection, the outer cutting needle is pushed to cooperate with the inner needle. The outer cutting needle enters the gap between the marking and positioning clip and the inner needle, and pushes the connector to disengage from the limiting hole. After the connector disengages, the V-shaped clamping opening loses its limiting and opens, thereby clamping the marking and positioning clip in the tissue to achieve the positioning function. That is, the puncture biopsy can be completed in one operation using the puncture needle, while the marking and positioning clip is left in the tissue to achieve tumor positioning. There is no need to separate the puncture biopsy and tumor positioning into two steps, saving time and improving treatment efficiency. Moreover, compared with the two-step operation, it can effectively reduce the risk of wound infection and tumor dissemination, and improve safety.

[0018] Other solutions of the present invention achieve the following technical effects compared with the prior art:

[0019] After the marker positioning clip is dislodged from the inner needle, the clamping opening opens, and the interlocking surface in the middle of the clamping opening is serrated, which can more firmly clamp the tissue at the positioning site and prevent it from falling off.

[0020] The smooth, plate-like design of the marker positioning clip increases the reflective area of ​​light and sound sources, making it easy to locate by ultrasound and the naked eye even if it springs out during positioning.

[0021] The position of the marker positioning clip can be finely adjusted by pulling the line, which improves the positioning accuracy and avoids the problem of inaccurate positioning caused by the marker positioning clip being too deep when using an automatic ejection controller due to the large ejection force. Attached Figure Description

[0022] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0023] Figure 1 This is a schematic diagram of the puncture end of the biopsy locator of the present invention;

[0024] Figure 2 for Figure 1 Enlarged view of the structure at point A in the middle;

[0025] Figure 3 This is a schematic diagram of the marking and positioning clip of the present invention;

[0026] Figure 4 This is a schematic diagram of the structure of the present invention when the V-groove and the limiting hole are directly set on the inner needle;

[0027] Among them, 1. Cutting outer needle; 2. Inner needle; 3. Marking and positioning clip; 4. Tissue groove; 5. V-groove; 6. Limiting hole; 7. Sliding part; 8. Insertion part; 9. V-shaped clamping port; 10. Pulling hole; 11. Speed ​​bump; 12. Blade; 13. Sleeve; 14. Mounting groove; 15. Base. Detailed Implementation

[0028] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0029] The purpose of this invention is to provide a puncture biopsy locator to solve the problems existing in the prior art. It can simultaneously push out the marker positioning clip during puncture sampling, so that the puncture needle has a positioning function. It can complete puncture biopsy and tumor localization in one operation, thereby improving the efficiency and safety of the overall treatment.

[0030] To make the above-mentioned objects, features and advantages of the present invention more apparent and understandable, the present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments.

[0031] Please refer to the following: Figures 1-4As shown, a biopsy locator is provided, which adds a marking and positioning clip 3 compared to a conventional puncture needle. The entire device includes a controller, an outer cutting needle 1, an inner needle 2, and the marking and positioning clip 3. The end of the outer cutting needle 1 is a ring blade for cutting. The puncture end of the inner needle 2 has a tissue groove 4. The outer cutting needle 1 is slidably sleeved on the inner needle 2, and the inner diameter of the outer cutting needle 1 matches the outer diameter of the inner needle 2. Unlike a conventional puncture needle, the inner needle 2 has a V-groove 5. Preferably, the V-groove 5 is opposite to the tissue groove 4, and the V-groove 5 penetrates both radially on the inner needle 2. A limit hole 6 is formed on the inner wall surface of the V-groove 5 away from the puncture end. The bottom of the marking and positioning clip 3 is provided with a sliding member 7. 7 can be a block structure. The end of the sliding member 7 away from the puncture end is provided with a connector 8. The connector 8 can be a plate structure. The surface of the sliding member 7 near the puncture end is set at an acute angle with the marking positioning clip 3. The sliding member 7 slides in cooperation with the inner wall surface of the V-groove 5 near the puncture end. Specifically, the surface of the sliding member 7 near the puncture end can be a plane or curved surface that is furthest from the marking positioning clip 3 from other points. The inner wall surface of the V-groove 5 near the puncture end is adapted to the surface of the sliding member 7 near the puncture end. The connector 8 is inserted into the limiting hole 6. The marking positioning clip 3 has a V-shaped clamping port 9 with an opening facing the puncture end. The V-shaped clamping port 9 penetrates downward through the sliding member 7 and the connector. 8. The width of the limiting hole 6 is the same as the width of the connector 8 when the V-shaped clamping opening 9 is closed. The marking positioning clip 3, the sliding member 7, and the connector 8 are made of pure titanium or titanium alloy to give them shape memory function, allowing the connector 8 to be inserted into the limiting hole 6. The height of the limiting hole 6 is greater than the thickness of the connector 8. After the connector 8 is inserted into the limiting hole 6, it should be located in the lower space of the inner cavity of the limiting hole 6. The upper space is the space provided for the connector 8 to move upward when the sliding member 7 slides forward. There is a gap between the marking positioning clip 3 and the inner needle 2 for the outer cutting needle 1 to pass through. The sliding member 7 is located on the movement path of the outer cutting needle 1. The outer cutting needle 1 pushes the sliding member 7 to make the connector 8 move upward. When the connector 8 disengages from the limiting hole 6, the end face of the sliding member 7 near the connector 8 should be a vertical plane perpendicular to the axis of the inner needle 2, or an inclined plane closer to the puncture end than the end further away from the axis of the inner needle 2, to facilitate the cutting of the outer needle 1. After the connector 8 disengages from the limiting hole 6, the opening length of the V-shaped clamping port 9 at the free end of the connector 8 should not be less than the length of the chord line corresponding to the inner needle 2 and the connector 8. Specifically, taking the connector 8 disengaging from the top of the inner cavity of the connector hole as an example, when the connector 8 disengages, the V-shaped clamping port 9 opens, and the opening at the connector 8 is the movement opening. At this time, the length of the chord line of the inner needle 2 directly opposite the front of the connector 8 should not be greater than the length of the movement opening.This device utilizes a movable opening to prevent the inner needle 2 from obstructing the forward movement of the connector 8 and the sliding member 7. During the tissue retrieval process, as the outer cutting needle 1 is pushed to cooperate with the inner needle 2, the outer cutting needle 1 enters the gap between the marking and positioning clip 3 and the inner needle 2, pushing the connector 8 out of the limiting hole 6. After the connector 8 is dislodged, the V-shaped clamping opening 9 loses its limiting position and opens, thereby clamping the marking and positioning clip 3 within the tissue to achieve the positioning function. In other words, a single puncture biopsy can be completed with the puncture needle, while the marking and positioning clip 3 remains within the tissue to achieve tumor localization. This eliminates the need for separate puncture biopsy and tumor localization procedures, saving time and improving treatment efficiency. Furthermore, compared to a two-step procedure, it effectively reduces the risk of wound infection and tumor dissemination, improving safety.

[0032] Guide surfaces can be provided on both sides of the inner wall of the V-groove 5 near the puncture end. The guide surfaces are inclined surfaces, and the two inclined surfaces form a figure-eight structure with the opening facing the puncture end. The guide surfaces correct and guide the movement of the insert 8. Alternatively, the opening length of the V-shaped clamping port 9 at the free end of the insert 8 can be set to be greater than the length of the chord line corresponding to the inner needle 2 and the insert 8, so as to prevent the insert 8 from radially shifting when it comes out of the limiting hole 6 and being blocked by the inner needle 2.

[0033] To improve structural strength, the sliding member 7, the plug-in member 8, and the marking and positioning clip 3 are integrally formed.

[0034] Since the marking and positioning clip 3 and the sliding member 7 need to be inserted into the tissue during the process of being pushed by the cutting outer needle 1, the connection between the sliding member 7 and the marking and positioning clip 3 is set to be conical to improve the convenience of insertion. The conical structure can be formed directly by the plane of the marking and positioning clip 3 and the surface of the inclined sliding member 7, or the front end of the marking and positioning clip 3 can be inclined or bent towards the inner needle 2 to form a conical structure with the surface of the inclined sliding member 7.

[0035] In this embodiment, the width of the slider 7 is smaller than the width of the mark positioning clip 3. The front end of the mark positioning clip 3 is not corresponding to the position of the slider 7, and a guide surface is also provided at an acute angle to it. The guide surface is the plane or curved surface that is furthest from the upper surface of the mark positioning clip 3 compared to other points.

[0036] The V-shaped clamping opening 9 has a serrated interlocking surface in the middle, which can more firmly clamp the tissue at the positioning point and prevent it from falling off.

[0037] The marking and positioning clip 3 is plate-shaped, and its outer surface is smooth to increase the reflection area of ​​the light source and sound source. Even if it is ejected during the positioning process, it is easy to locate by ultrasound and the naked eye.

[0038] Since the puncture needle controller has both manual and automatic controllers, both controllers need to control the forward movement of the outer needle. This may result in a situation where the pushing speed is too high, causing the marker positioning clip 3 to enter a deeper position in the tissue. Therefore, a pull hole 10 is provided at the end of the marker positioning clip 3 away from the puncture end of the inner needle 2. A pull line is provided in the pull hole 10. Specifically, the pull line is threaded through the pull hole 10. By controlling the pull line externally, the position of the marker positioning clip 3 can be adjusted externally, thereby improving the positioning accuracy.

[0039] A deceleration belt 11 can be provided on the outer surface of the inner needle 2 corresponding to the marking positioning clip 3 to slow down the advancing speed of the cutting outer needle 1. The deceleration belt 11 can be a semi-circular protrusion structure. The cross-section of the semi-circular protrusion structure can be semi-circular. The outer diameter of the semi-circular protrusion structure is slightly larger than the diameter of the inner needle 2. At this time, the inner diameter of the cutting outer needle 1 should ensure that it can pass through the deceleration belt 11.

[0040] Since a scalpel is needed to cut the incision during a biopsy, in order to improve the versatility of the device, reduce the time spent searching for and retrieving the scalpel, and improve surgical efficiency, a blade 12 is detachably provided at the puncture end of the inner needle 2 in this device. Specifically, the detachable structure is as follows: one end of the blade 12 is inserted into the inner needle 2 through a sleeve 13.

[0041] The V-groove 5 and the limiting hole 6 can be directly set on the inner needle 2; or an installation groove 14 can be set at the position of the positioning clip 3 corresponding to the inner needle 2. A base 15 is set in the installation groove 14. A pin can be set at the bottom of the base 15. A pin hole is set in the installation groove 14 so that the base 15 can be directly inserted into the installation groove 14. The inner side wall of the installation groove 14 near the puncture end slides with the sliding member 7. The limiting hole 6 is set at one end of the base 15 near the puncture end. That is, the inner side wall of the installation groove 14 near the puncture end and the end face of the base 15 near the puncture end form a V-groove 5.

[0042] The base 15 should not affect the movement of the outer cutting needle 1. The base 15 can be a cylindrical structure that is assembled with the inner needle 2 to form a complete cylinder; or a cylindrical structure with a rectangular or trapezoidal cross section. When the cross section of the base 15 is rectangular, the distance between the corner of the rectangle and the axis of the inner needle 2 should not be greater than the radius of the inner needle 2; or a combination of the two shapes mentioned above.

[0043] Scale lines can be set on the outer peripheral walls of the inner needle 2 and the cutting outer needle 1. The scale lines can be strip-shaped raised structures or strip-shaped recessed structures, with the aim of making the scale visible. In actual use, since the inner needle 2 extends out of the cutting outer needle 1 in the initial state, the end of the cutting outer needle 1 can be controlled by the controller to be at a certain scale value on the inner needle 2 (the manual controller can be adjusted manually, and the automatic controller can determine the extension length of the inner needle 2 during production to determine the scale value of the inner needle 2 corresponding to the initial state of the cutting outer needle 1). In this way, the puncture depth can be accurately controlled by observing the scale during puncture. When the inner needle 2 is inserted into the body and the cutting outer needle 1 is not inserted into the body, the scale on the inner needle 2 can be read directly. When both the inner needle 2 and the cutting outer needle 1 are inserted into the body, the scale value on the cutting outer needle 1 should be read and the scale value of the inner needle 2 corresponding to the cutting outer needle 1 should be added.

[0044] In actual use, in the initial state, the inner needle 2 extends out of the cutting outer needle 1, exposing the V-groove 5, and is fitted with the blade 12. When the device includes the base 15, the base 15 is installed first, and then the marking and positioning clip 3 is inserted into the limiting hole 6 through the connector 8. At this time, the normal operation begins. First, the blade 12 is used to cut open the puncture site. After removing the blade 12, the inner needle 2 is inserted into the body to the designated position. The controller controls the cutting outer needle 1 to move forward, enter the gap between the marking and positioning clip 3 and the inner needle 2, and pushes the connector 8 out of the limiting hole 6. After the connector 8 is removed, the limiting hole 6 loses its restriction on the left and right sides of the connector 8, the V-shaped clamping port 9 opens by itself, and clamps in the designated position to complete the positioning. At the same time, during the forward movement of the cutting outer needle 1, part of the tissue is cut off and stored in the tissue groove 4 of the inner needle 2, completing the tissue cutting work.

[0045] Any adaptive changes made according to actual needs are within the scope of protection of this invention.

[0046] It should be noted that, for those skilled in the art, it is obvious that the present invention is not limited to the details of the exemplary embodiments described above, and that the invention can be implemented in other specific forms without departing from the spirit or essential characteristics of the invention. Therefore, the embodiments should be considered illustrative and non-limiting in all respects, and the scope of the invention is defined by the appended claims rather than the foregoing description. Thus, all variations falling within the meaning and scope of equivalents of the claims are intended to be included within the present invention. No reference numerals in the claims should be construed as limiting the scope of the claims.

[0047] Specific examples have been used to illustrate the principles and implementation methods of this invention. The descriptions of the above embodiments are only for the purpose of helping to understand the method and core ideas of this invention. Furthermore, those skilled in the art will recognize that, based on the ideas of this invention, there will be changes in the specific implementation methods and application scope. Therefore, the content of this specification should not be construed as a limitation of this invention.

Claims

1. A biopsy locator, comprising an outer cutting needle with a cutting function at its end, an inner needle with a tissue groove at its puncture end, and a controller for controlling the movement of the outer cutting needle and the inner needle, characterized in that, The biopsy locator also includes a marker positioning clip with elastic self-recovery function. A V-shaped groove is formed on the inner needle, extending radially through both sides of the inner needle. A limiting hole is formed on the inner wall surface of the V-shaped groove away from the puncture end. A sliding member is provided at the bottom of the marker positioning clip, and a connector is provided at the end of the sliding member away from the puncture end. The surface of the sliding member near the puncture end forms an acute angle with the marker positioning clip. The sliding member slides in cooperation with the inner wall surface of the V-shaped groove near the puncture end. The connector is inserted into the limiting hole. The marker positioning clip has a V-shaped clamping opening facing the puncture end, extending downwards through the sliding member and the connector. The width of the limiting hole... The width of the connector is the same as that of the V-shaped clamp when it is closed. The height of the limiting hole is greater than the thickness of the connector. There is a gap between the marking positioning clamp and the inner needle for the cutting outer needle to pass through. The sliding member is located on the movement path of the cutting outer needle. The cutting outer needle pushes the sliding member to make the connector disengage from the limiting hole. After disengagement, the opening length of the V-shaped clamp at the free end of the connector is not less than the length of the chord line corresponding to the inner needle and the connector. During the process of the cutting outer needle being pushed to cooperate with the inner needle to complete tissue cutting, the cutting outer needle enters the gap between the marking positioning clamp and the inner needle and pushes the connector out of the limiting hole.

2. The biopsy locator according to claim 1, characterized in that, The slider, the connector, and the marking and positioning clip are integrated into one unit.

3. The biopsy locator according to claim 2, characterized in that, The sliding member is connected to the end of the marking and positioning clip near the puncture end of the inner needle, and the connection between the sliding member and the marking and positioning clip is tapered.

4. The biopsy locator according to claim 1, characterized in that, The marking and positioning clip, the sliding member, and the plug-in member are made of pure titanium or titanium alloy.

5. The biopsy locator according to claim 4, characterized in that, The marking and positioning clip is plate-shaped, and its outer surface is smooth.

6. The biopsy locator according to claim 1, characterized in that, The inner walls on both sides of the V-shaped clamping opening have interlocking tooth-like structures.

7. The biopsy locator according to claim 1, characterized in that, The end of the marker positioning clip away from the puncture end is provided with a pull hole, and a pull line for pulling and adjusting the position of the marker positioning clip outside the body is provided in the pull hole.

8. The biopsy locator according to claim 7, characterized in that, The inner pin has a deceleration band on its outer surface corresponding to the outer surface of the marking and positioning clamp to slow down the advancing speed of the cutting outer pin.

9. The biopsy locator according to claim 1, characterized in that, The puncture end of the inner needle is detachably equipped with a blade.

10. The biopsy locator according to claim 1, characterized in that, The V-groove and the limiting hole are directly provided on the inner needle; or the inner needle is provided with an installation groove corresponding to the position of the marking positioning clip, a base is provided in the installation groove, the inner side wall of the installation groove near the puncture end is slidably engaged with the sliding member, and the limiting hole is provided at one end of the base near the puncture end.

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