Biopsy needle set with reduced deflection and improved orientation

Abstract

A biopsy needle set includes a biopsy needle having a needle tip terminating distally at a laterally extending cutting edge, the cutting edge being spaced above a bottom surface of the biopsy needle. The proximal end of the biopsy needle has a support having a bottom surface below the central axis of the biopsy needle and a row of teeth extending upwardly from both sides of the bottom surface to near the central axis. The teeth of each row are away from each other, and the teeth of the two rows are distributed in a staggered manner, so that some cross sections of the support only comprise one tooth, and some cross sections do not comprise teeth. The outer surface of the support is tightly attached to the inner surface of the sleeve, so that the biopsy needle is kept in the center of the sleeve, bending is prevented, and target tissue needing to be sampled can be better aimed.

Description

Technical Field

[0001] This patent specification relates to needle biopsy instruments and methods, including but not limited to instruments for obtaining prostate tissue samples. Background Technology

[0002] For a long time, slotted biopsy needle kits have been used to obtain tissue samples. A standard treatment (SOC) needle kit includes a needle (also known as a core needle or hollow needle) with a sharp tip for penetrating tissue, a proximal groove for access to surrounding tissue, and a shank. The kit further includes a cutting cannula coaxially fitted over the biopsy needle and having a sharp distal edge. The kit can be used with fully manual instruments, where the operator manually pushes the biopsy needle into the tissue until the groove enters the target tissue, then manually pushes the cannula towards the needle tip, cutting and retaining the tissue within the groove, while simultaneously withdrawing the kit from the tissue. When used with semi-automatic instruments, the operator manually pushes the biopsy needle into the tissue in the same manner, then releases the spring-loaded cutting cannula, cutting and retaining the tissue sample. For fully automated instruments, both the biopsy needle and the cannula are spring-loaded simultaneously. Medical personnel insert a biopsy needle into the patient, with the cannula covering the groove, until the needle tip approaches or reaches the target tissue. The needle is then released, propelling distally into the tissue to be sampled. A spring-loaded cutting cannula then extends distally, cutting the sample and retaining it within the groove. The biopsy needle sheath is then removed from the patient, and the cannula is pulled back to expose and retrieve the tissue sample from the groove for initial evaluation and / or delivery to a pathology laboratory.

[0003] A key requirement for this type of operation is to obtain tissue samples that are as large and complete as possible in volume, cross-section, and length, given a limited cross-section of the biopsy needle kit, to ensure that these samples accurately represent the tissue being cut. Another important requirement is to prevent the biopsy needle from bending in the finer grooves, which could lead to missed target tissue and / or interference with the living tissue.

[0004] This patent specification aims to provide instruments and methods that meet the above and other needs, and to provide further improvements to biopsy needle kits and related methods. Summary of the Invention

[0005] According to some embodiments, a biopsy needle kit includes a biopsy needle extending along a central axis located horizontally midway between the top and bottom boundaries of the biopsy needle. The needle includes a needle tip, a support proximal to the needle tip, and a shank proximal to the support. The needle tip includes an upper and a lower cut surface that converge distally to form a distal cutting edge located distal to the needle tip and extending laterally. The support includes an upward-facing bottom surface located between the central axis and the bottom boundary of the biopsy needle, and has sides on both sides of the central axis and a row of teeth extending upwards from each side of the bottom surface to a level near the central axis. Each row of teeth is spaced apart from each other along the central axis. The laterally extending distal cutting edge is spaced above the bottom boundary of the biopsy needle but below the horizontal level of the support bottom surface.

[0006] According to some embodiments, the biopsy needle assembly may further include one or more of the following features: (a) the distal cutting edge is located horizontally at a certain distance from the bottom boundary of the biopsy needle, the distance being approximately one-third of the distance from the bottom boundary of the biopsy needle to the horizontal level of the support base; (b) the distal cutting edge is located horizontally at a certain distance from the bottom boundary of the biopsy needle, the distance being 0.015 inches ± 0.005 inches; (c) the upper and lower cutting surfaces may include two adjacent lower cutting surfaces; (d) the lower cutting surface may include two lower cutting surfaces converging to form a vertical blade, the blade being located below the laterally extending cutting edge and extending proximally from the laterally extending cutting edge; (e) the upper and lower cutting surfaces may include two lower cutting surfaces, each lower cutting surface having a length along the central axis that is less than that of the upper cutting surface. (f) The teeth are arranged such that some cross sections of the support contain only one tooth, while some cross sections do not contain any teeth; (g) The laterally extending distal cutting edge may be V-shaped in a top view; (h) The laterally extending distal cutting edge may include two parts, each extending along its own straight direction; (i) The laterally extending distal cutting edge extends along a single straight line; (j) The laterally extending distal cutting edge extends along at least one curve; (k) The assembly may further include a hollow cutting sleeve that can slide around the biopsy needle along its central axis distal and proximal ends, such that when a portion of the support extends distally from the sleeve, the outer bottom surface of the support and the outer surface of the teeth are in close contact with the inner surface of the sleeve, keeping the biopsy needle in the center position of the sleeve and reducing the bending of the biopsy needle. Attached Figure Description

[0007] Figure 1 This is a left-side view of the distal portion of the biopsy needle in some embodiments.

[0008] Figure 2 This is a magnified left-side view of the distal portion of the biopsy needle in some embodiments.

[0009] Figure 3 This is a perspective view of the distal portion of the biopsy needle as seen from the left side of the biopsy needle in some embodiments.

[0010] Figure 4 This is a perspective view of the distal portion of the biopsy needle as seen from the left distal end of the needle in some embodiments.

[0011] Figure 5A This is a left-side view of a portion of the biopsy needle in some embodiments. Figure 5B A comparative view of a portion of the existing standard treatment biopsy needles.

[0012] Figure 6A This is a left perspective view of a portion of the biopsy needle in some embodiments. Figure 6B A comparative perspective view of a portion of the existing standard treatment biopsy needle.

[0013] Figure 7 The comparison shows the use of a standard treatment (SOC) biopsy needle kit with biopsy needles as described in some embodiments of this patent specification.

[0014] Figure 8 The following are front views of biopsy needles in some embodiments. Detailed Implementation

[0015] The following provides a detailed description of examples of preferred embodiments. Although multiple embodiments are described, the novel subject matter described in this specification is not limited to any single embodiment or combination of embodiments, but encompasses all alternatives, modifications, and equivalents. Furthermore, for clarity, numerous specific details are listed in the following description, but some embodiments may be implemented without referring to some or all of these details. In addition, for clarity, certain technical materials known in the relevant art are not described in detail to avoid unnecessarily obscuring the novel subject matter described in this specification. It should be understood that individual features of one or more specific embodiments described in this specification may be combined with features of other embodiments, or with other features. The same reference numerals and identifiers in different drawings denote the same elements.

[0016] Figure 1 This is a left-side view of a portion of the biopsy needle 100 in some embodiments. Figure 2This is an enlarged view of the distal portion of a biopsy needle in some embodiments. The biopsy needle extends along a central axis A and includes a needle tip 102, a support 104 located proximal to the needle tip, and a shank 106 located proximal to the support. The central axis A is located at the center of a cross-section passing through the shank 106. The bottom boundary of the biopsy needle 100 is located at level B, and the top boundary of the biopsy needle 100 is located at level C. The shank 106 has... Figure 1 and Figure 2 The part that extends further to the right ( Figure 1 and Figure 2 (not shown in the image), and has a fixed or detachable connection to the instrument ( Figure 1 and Figure 2 (Not shown in the image, but referred to in the following description) the proximal end. The biopsy needle 100 is typically part of a biopsy needle kit, which further includes a cutting cannula 108. Figure 2 The proximal portion of cannula 108 is shown. The cutting cannula 108 has a sharp distal end 108a and can slide distally and proximally while surrounding the biopsy needle 100. Cannula 108 has a further rightward extension (…). Figure 2 (Not shown in the image), and can be connected to the instruments described later.

[0017] It needs to be clarified that the positional terms such as "up," "down," "above," and "below" are based on the biopsy needle 100 at... Figure 1 and Figure 2 The orientations shown may vary. If the orientation of the biopsy needle 100 relative to the observer is different, these positional terms need to be adjusted accordingly.

[0018] Figure 3 This is a perspective view of the distal portion of the biopsy needle 100 as seen from the left side of the biopsy needle in some embodiments, showing a bottom surface 104a with the support 104 facing upwards, a left row of teeth 104b extending upwards from the left side of the bottom surface 104a, and a right row of teeth 104c extending upwards from the right side of the bottom surface 104a. Figure 2 As shown, the bottom surface 104a is located at level D below the central axis A. Teeth 104b extend upwards to or approximately to the level of the central axis A, that is, to or approximately to half the diameter of the biopsy needle 100 within the cross-section of the needle shank 106, as do teeth 104c. The teeth 104b in the left row are spaced apart axially. The teeth 104c in the right row are also spaced apart axially. For example, a row of teeth can be arranged as follows: Figure 1 The arrangement shown is spaced along the axial direction and scaled according to the specific biopsy needle size. Figure 1In this example, the spacing between each tooth and its adjacent teeth in the same row is 2-3 times the axial length of that tooth at the horizontal position of the support bottom surface 104a. In this example, the spacing between the farthest tooth and the needle tip 102 is at least the axial length of one tooth, and the spacing between the nearest tooth and the needle shank 106 is at least the axial length of one tooth. For example, for a support 104 with an axial length of 20 mm, one row can have 3 teeth, while another row can have 4 teeth.

[0019] Preferably, the left and right rows of teeth are staggered so that some cross sections passing through the support 104 (such as section F) contain a tooth (such as 104b or 104c), while some cross sections (such as section G) do not contain any teeth. For example, cross sections such as G do not have any structure located above the bottom surface 104a of the support.

[0020] An important feature of the biopsy needle 100 is the shape of the distal portion of the needle tip 102, including how the distal cutting edge 102a is raised above the level B where the bottom boundary of the biopsy needle 100 is located, and how the cutting edge 102a extends in a direction parallel or substantially parallel to the bottom surface 104a of the support (which may be flat or curved, such as slightly concave or convex).

[0021] like Figure 2 As shown, the needle tip 102 terminates distally at a sharp distal cutting edge 102a, formed by the convergence of an upper cutting surface 102b and a lower cutting surface 102c. The cutting edge 102a is located at a level E above level B, where the bottom boundary of the biopsy needle 100 is located, but below level D, where the bottom surface 104a of the support 104 is located. Preferably, the level E where the cutting edge 102a is located is approximately one-third of the distance between levels B and D, but this value can vary. In a specific example, this distance is 0.015 inches (0.0381 cm) or 0.015 inches (0.0381 cm) ± 0.005 inches (0.0127 cm).

[0022] Figure 4 This is a perspective view of the distal portion of the biopsy needle 100, viewed from the left distal end of the biopsy needle in some embodiments. The distal end of the tooth 104c is at... Figure 4 The cutting edge 102a is not visible in the center. It has a left portion 102a1 and a right portion 102a2. The left portion 102a1 is formed by the convergence of the upper cutting surface 102b and the lower left cutting surface 102c1, and the right portion 102a2 is formed by the convergence of the upper cutting surface 102b and the lower right cutting surface 102c2. The lower cutting surfaces 102c1 and 102c2 converge at the blade 102d, and the three cutting surfaces intersect at point 102c. In the top view of the biopsy needle 100, the cutting edge 102a is V-shaped. Figure 2 As shown, the angle α between the upper tangent plane 102b and the central axis A is smaller than the angle β between the lower tangent plane 102c and the central axis A.

[0023] Figure 5A This is a left-side view of a portion of the biopsy needle 100. Figure 5B Comparative view of a portion of a standard treatment biopsy needle 500. In both cases, the biopsy needle is typically part of a biopsy needle kit, which further includes a cutting cannula. Figure 5A The cutting sleeve 108 is shown schematically. Figure 5B A similar cutting cannula 508 is schematically shown. An important difference is that the standard treatment biopsy needle 500 has no teeth in its groove 504a, while the biopsy needle 100 has teeth 104b and 104c. Another important difference is that the standard treatment needle 500 terminates distally at point 502a at the bottom horizontal level K of the biopsy needle 500, while the biopsy needle 100 terminates distally at a laterally extending blade 102a (instead of a point), which is spaced above the bottom boundary of the biopsy needle 100 at horizontal level B and includes blade portions 102a1 and 102a2.

[0024] Figure 6A and 6B respectively with Figure 5A and 5B Correspondingly, but the view of the biopsy needle shown comes from the left side of the distal end of the needle tip 102 and 502. Figure 6B This shows that the needle tip terminates distally at the point where the lateral sections 502a and 502b intersect the superior section 502c. Conversely, as... Figure 6A As shown, the needle tip 102 terminates distally at a laterally extending blade 102a (including blades 102a1 and 102a2, rather than a point). Figure 6A and 6B It also shows that the cutting edge 102a is above the bottom boundary of the needle 100, while the point 502a is at the level of the bottom boundary of the biopsy needle 500.

[0025] These differences have a significant impact on the intended use of biopsy needle kits, which will be discussed in the following sections in conjunction with their typical applications.

[0026] like Figure 5A , 5BBiopsy needle kits shown in 6A and 6B are typically used as part of a biopsy instrument, which medical personnel use to obtain tissue samples and observe for signs of disease such as the presence and nature of malignant cells. These instruments can be manual, semi-automatic, or fully automatic. A manual instrument is discussed in U.S. Patent No. 3,447,423, which is incorporated herein by reference. A biopsy needle, such as a biopsy needle 500 (but the distal shape may differ), is fixedly mounted on a handle. The biopsy needle extends distally from the handle, and a cutting cannula, such as a cannula 508, is installed in the handle, allowing it to slide distally and proximally around the periphery of the biopsy needle. The medical personnel manually insert the biopsy needle distally into the patient tissue until its recess 504 enters the target tissue, and then manually push the cannula 508 distally to cut the tissue extending into the recess 504. Subsequently, the medical personnel withdraw the biopsy needle and cannula from the patient, pulling the cannula proximally relative to the biopsy needle to expose the tissue sample in the recess and retrieve the sample for analysis. U.S. Patent No. 4,907,599 discusses a semi-automatic biopsy instrument, which is incorporated herein by reference. Unlike manual instruments, the semi-automatic instrument releases a spring-loaded cannula that covers the biopsy needle and extends distally to cut tissue inserted into the needle groove. U.S. Patent No. 6,358,217 discloses a fully automated instrument as an embodiment, differing in that both the biopsy needle and the cannula are spring-loaded. A medical professional inserts the biopsy needle into the patient, at which point the cutting cannula covers the groove until the distal end of the biopsy needle-cannula assembly approaches the target tissue. The spring-loaded biopsy needle is then released, extending distally so that its groove or support enters the target tissue. After the tissue has entered the groove or support, the spring-loaded cutting cannula extends distally to cut a tissue sample.

[0027] The biopsy needle 100 and the cutting cannula 108 have a proximal end (not shown) that can be fixed to the biopsy instrument in a manner similar to that shown in the aforementioned patents No. 3,447,423, No. 4,907,599 and No. 6,358,217, and the proximal end or proximal portion of the biopsy needle and cannula can be adjusted as appropriate.

[0028] The goal of tissue biopsy is to obtain the largest and most complete tissue sample from the patient within the constraints of the biopsy needle and cannula size—that is, to obtain a sample that closely resembles its morphology and characteristics in living tissue. When performing medical procedures using biopsy instruments, it is important to improve the orientation accuracy of the target tissue by keeping the biopsy needle centered on the cannula, while simultaneously increasing the size and integrity of the tissue sample.

[0029] The needle tip 102 and support 104 described in this patent specification employ a laterally extending cutting edge 102a, which is higher than the level of the bottom boundary of the biopsy needle, which helps to further improve orientation accuracy and tissue sample quality.

[0030] Figure 7 It shows the use of, as Figure 5A and 5B The images show a comparison between a standard treatment (SOC) biopsy needle kit with a slotted biopsy needle and a biopsy needle kit with biopsy needle 100 as described in this patent. The images show the penetration of the biopsy needle kit into a ballistic gel in which equidistant vertical dye lines are injected. In both cases, the biopsy needle kit is mounted on a widely used biopsy instrument—the Bard Magnum biopsy gun—equipped with a spring-loaded biopsy needle and a cutting sleeve. The dark upper and lower lines in the images are dye lines, initially nearly vertical. The top portion of each column of images shows the initial stage of penetration into the gel using the biopsy needle and the cutting sleeve surrounding the needle slot (left column images) and the support (right column images). In semi-automatic and automatic biopsy instruments, it is common practice at this stage for the cutting sleeve to cover the slot or support of the biopsy needle. The upper left image shows penetration using the SOC biopsy needle kit, and the upper right image shows penetration using biopsy needle 100 and sleeve 108. As shown in the figures, the dye line displacement is greater in the left image, indicating greater tissue displacement and interference when using the SOC biopsy needle kit. The second row of images from the top shows a significant performance difference in the distal ejection phase of the biopsy needle relative to the cannula. With the SOC biopsy needle kit, the biopsy needle begins to bend upwards, while biopsy needle 100 does not exhibit this upward bend, indicating more accurate orientation. The third and fourth rows of images from the top show an even more significant difference—the SOC biopsy needle bends more, indicating a failure to accurately orient the target tissue, while biopsy needle 100 moves along a straight path. The last row of images shows the distal ejection phase with the cutting cannula outside the needle groove or support. The difference is very pronounced—the SOC biopsy needle kit causes greater interference and displacement of the gel compared to the kit using biopsy needle 100 and cannula 108. Part of the reason for this difference may be that driving the cannula, which bends outside the biopsy needle within the SOC kit, pulls the gel downwards from its initial position. Since the biopsy needle 100 did not bend in this way, it did not cause such a situation. Therefore, when the cannula 108, which is sleeved outside the biopsy needle 100, is driven, it will not pull the gel downward or cause the gel to shift in other ways as shown in the left figure.

[0031] The biopsy needle 100 is able to be better oriented, partly due to the configuration of the support 104 and its teeth 104b and 104c relative to the cannula 108. As described in detail in the similar structure in the aforementioned parent patent application incorporated by reference, when the support 104 is moved distally out of the cannula 108 into the target tissue, the lower surface of the support 104 and the outer surface of the teeth extending upward from the bottom of the support are in close contact with the inner surface of the cannula 108, thereby keeping the distal portion of the biopsy needle 100 more straight and keeping the portion of the support 104 within the cannula 108 centered in the cannula.

[0032] The orientation is further improved because the distal end of the needle tip 102 is designed as a laterally extending cutting edge 102a, rather than a point like that of a SOC biopsy needle (e.g., Figure 5B and 6B As shown). Figure 7 The experiments and tissue experiments shown indicate that, with Figure 5B and 6B Compared to a needle tip where the mid-cutting point is at the level of the bottom of the biopsy needle and the upper cut begins from that point, the biopsy needle 100 exhibits less vertical displacement of the tissue as it enters distally, thus facilitating better orientation.

[0033] As described in detail in the incorporated parent patent application, a biopsy needle with a support (such as support 104) yields higher quality tissue samples compared to a SOC biopsy needle with open grooves. An expert statement filed in the aforementioned parent application 17 / 082,387 (expected to be published as patent number 11,903,569) confirms that, in patient trials, the toothed biopsy needle significantly and unexpectedly outperformed the SOC biopsy needle with open grooves. This superior performance includes larger cross-sections, greater volume, and less deformation (such as stretching, fracturing, or aggregation) of the obtained tissue samples, which the SOC biopsy needle cannot achieve.

[0034] Figure 8 A front view of the tip 102 of the aforementioned biopsy needle 100 is shown. According to... Figure 2 The annotation in the text, Figure 8 The front view shows: (i) level B where the bottom of the biopsy needle 100 is located, (ii) level E where the cutting edge 102a is located (the cutting edge 102a may include a left portion 102a1 and a right portion 102a2), (iii) level D where the support bottom surface 104a is located, (iv) central axis A, with teeth 104b and 104c extending upward to the central axis A, and (v) level C where the top of the biopsy needle 100 is located. It is noteworthy that the cutting edge 102a at level E is spaced above level B where the bottom of the biopsy needle is located, but below level D where the support bottom surface is located, which itself is also below the central axis A.

[0035] Although some embodiments have been described in detail for clarity, it is obvious that certain changes and modifications can be made without departing from the principles. The processes and apparatus described in this invention can be implemented in other alternative ways. As a non-limiting example, the shape of the distal cutting edge 102a in a top view may not be V-shaped, but rather a straight line or other shape, such as a laterally extending straight line or curve. Therefore, the embodiments described in this invention should be considered illustrative rather than restrictive, and the working principle of this invention is not limited to the details given herein, which can be modified within the scope and equivalents of the appended claims.

Claims

1. A biopsy needle kit comprising a biopsy needle (100) extending along a central axis (A), the central axis being located at a horizontal midpoint between a top boundary (C) and a bottom boundary (B) of the biopsy needle, wherein, The biopsy needle includes: A needle tip (102), a support (104) located proximal to the needle tip, and a needle shank (106) located proximal to the support; wherein, The support includes an upward-facing bottom surface (104a) located between the central axis and the bottom boundary of the biopsy needle, and has sides on both sides of the central axis and a row of teeth (104b, 104c) extending upward from each side of the bottom surface to a level close to the central axis. In this arrangement, the teeth in each row are spaced apart from each other along the central axis.

2. The biopsy needle kit according to claim 1, wherein, The teeth are staggered along the axial direction such that some cross sections (G) of the support contain only one tooth from one row, while some cross sections (F) contain no teeth.

3. The biopsy needle kit according to claim 1, wherein, The needle tip includes an upper slit (102b) and a lower slit (102c1, 102c2), which converge at the distal end to form a distal cutting edge (102a; 102a1, 102a2), which is located at the distal end of the needle tip and extends in the lateral direction.

4. The biopsy needle kit according to claim 3, wherein, The laterally extending distal cutting edge is spaced above the bottom boundary of the biopsy needle, but is located below the horizontal plane of the support bottom surface.

5. The biopsy needle kit according to claim 1, wherein, The distal cutting edge is located horizontally at a certain distance above the bottom boundary of the biopsy needle, and the distance is approximately one-third of the distance from the bottom boundary of the biopsy needle to the bottom surface of the support.

6. The biopsy needle kit according to claim 1, wherein, The distal cutting edge is located horizontally at a certain distance above the bottom boundary of the biopsy needle, with a distance of 0.015 inches (0.0381 cm) ± 0.005 inches (0.0127 cm).

7. The biopsy needle kit according to claim 1, wherein, The upper and lower tangents include two adjacent lower tangents (102a1 and 102a2).

8. The biopsy needle kit according to claim 1, wherein, The lower cutting surface includes two lower cutting surfaces that converge to form a vertically oriented blade (102d), which is located below the laterally extending cutting edge and extends proximally from the laterally extending cutting edge.

9. The biopsy needle kit according to claim 1, wherein, The upper and lower tangents include two lower tangents, the length of which is less than the length of the upper tangent along the central axis.

10. The biopsy needle kit according to claim 1, wherein, The arrangement of the teeth is such that some cross sections of the support contain only one tooth, while some cross sections do not contain any teeth.

11. The biopsy needle kit according to claim 1, wherein, The laterally extending distal cutting edge is V-shaped in the top view.

12. The biopsy needle kit according to claim 1, wherein, The laterally extending distal cutting edge comprises two parts (102a1, 102a2), each extending along its respective straight direction.

13. The biopsy needle kit according to claim 1, wherein, The laterally extending distal cutting edge extends along a single straight line.

14. The biopsy needle kit according to claim 1, wherein, The laterally extending distal cutting edge extends along at least one curve.

15. The biopsy needle kit according to claim 1, further comprising a hollow cutting sleeve (108), the sleeve being slidable around the distal and proximal ends of the biopsy needle along its central axis, such that when a portion of the support extends distally out of the sleeve, the outer bottom surface of the support and the outer surface of the teeth are in close contact with the inner surface of the sleeve, thereby keeping the biopsy needle in the central position of the sleeve and reducing bending of the biopsy needle.

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