Needles, needle sets and devices including multi-sided biopsy needle tips and the like - Patents.com

Abstract

A multi-sided soft tissue penetrating element comprising three distal planar cutting edges, the three distal planar cutting edges meeting to form a sharp distal point of the tissue penetrating element. Each distal cutting edge forms a first angle with respect to a central longitudinal axis of the tissue penetrating element. The tissue penetrating element also comprises three proximal planar cutting edges. Each proximal cutting edge extends proximally from a respective one of the three distal planar cutting edges. Each proximal cutting edge forms a second angle with respect to the central longitudinal axis of the tissue penetrating element. The second angle is greater than the first angle.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application No. 63 / 284,820, filed December 1, 2021, the entire contents of which are incorporated herein by reference.

[0002] The present disclosure relates generally to the field of soft tissue sampling and harvesting. The present disclosure relates more specifically to needle tip designs for biopsy needles, needle sets, and / or devices capable of sampling soft tissue. [Background technology]

[0003] introduction The section headings used herein are for organizational purposes only and should not be construed as limiting the subject matter described in any way.

[0004] In the practice of diagnostic medicine, it is often necessary or desirable to perform a biopsy or sample selected tissue from a living patient for medical evaluation. Cytological and histological studies of the biopsy sample can then be performed as an aid in the diagnosis and treatment of disease. Biopsies can be useful in diagnosing and treating various forms of cancer, including, for example, breast cancer, and other diseases in which localized areas of diseased tissue can be identified.

[0005] Generally, preoperative diagnosis involving percutaneous biopsy is preferred over surgical biopsy. In percutaneous biopsy, the surgeon obtains a tissue sample through the skin with a needle set, as opposed to performing an actual surgical resection. One known needle set comprises an elongated outer cannula (needle) and an inner cannula, the elongated outer cannula having a sharp tissue-penetrating tip and a receiving opening defined near its distal end (adjacent to the tissue-penetrating tip), and the inner cannula having an open distal end surrounded by an annular cutting blade. The inner cannula is slidably disposed within the outer cannula such that it can close the tissue-receiving opening, thereby allowing cut tissue to escape through the tissue-receiving opening and into the lumen of the outer cannula (needle).

[0006] Percutaneous image-guided needle biopsy has become the preferred biopsy method, for example, in the management of suspicious breast lesions detected by screening or during evaluation of clinical abnormalities. Percutaneous image-guided needle biopsy is recognized as a safe and cost-effective procedure, allowing for accurate diagnosis, accurate decision-making, and, when indicated, accurate treatment planning. As a result, percutaneous image-guided needle biopsy has become the standard of care within the medical community, almost completely replacing diagnostic surgical excision, which was associated with longer hospital stays, higher costs, and possible complications.

[0007] There are also various technical options for breast tissue sampling, including, for example, fine needle sampling (FNS), core needle biopsy (CNB), and vacuum assisted biopsy (VAB), which may be used in conjunction with various imaging modalities for guidance. All of these various techniques are available for diagnosing palpable and non-palpable breast lesions, and each is generally used for different purposes. Thus, different biopsy techniques employ needles of different sizes and lengths. The diameter of the needle's (opening) lumen is described by the gauge number, with smaller gauge numbers indicating larger needle diameters. Commonly applied needles have lumen diameters ranging, for example, from about 0.4 mm (27 gauge) to about 4.6 mm (7 gauge).

[0008] VAB procedures generally require needle sets with relatively small gauges, ranging from about 12 gauge to about 7 gauge. Additionally, the standard of care for breast biopsies is shifting to utilize smaller gauge needles. Smaller gauge needles (with larger lumen diameters) are desirable for, for example, removing larger amounts of tissue and collecting multiple samples sequentially without having to remove the needle from the patient to provide enough tissue for a pathologist to make a diagnosis, thereby reducing the risk of false negative results or underestimation of disease. However, larger needles (with smaller gauges) also pose patient comfort issues, as it is generally more difficult to penetrate a patient's skin with such needles.

[0009] It may therefore be desirable to provide a needle tip for biopsy needles and / or needle sets, including, for example, small gauge biopsy needles and needle sets, having a design that improves the patient experience by more easily penetrating the patient's skin to collect soft tissue samples, promoting patient comfort, while also allowing for large scale manufacturing of the needles and / or needle sets for commercial use. It may further be desirable to provide a needle tip for biopsy needles and / or needle sets that allows for reduced insertion pressure as the needle enters the soft tissue, without simultaneously increasing the length of the needle. Summary of the Invention [Means for solving the problem]

[0010] summary The present disclosure addresses one or more of the problems set forth above and / or achieves one or more of the desired features set forth above. Other features and / or advantages may become apparent from the following description.

[0011] In accordance with various exemplary embodiments of the present disclosure, a biopsy needle for penetrating soft tissue comprises an elongate body extending between a proximal end and a distal end. The elongate body has a central longitudinal axis. The biopsy needle also comprises a tissue-piercing tip at a distal end of the elongate body. The tissue-piercing tip comprises a first set of facets defined by three first sides and three first cutting edges. Each first cutting edge is formed by adjacent ones of the three first sides, each first cutting edge forming a first angle with respect to the central longitudinal axis. The tissue-piercing tip also has a second set of facets located distal to the first set of facets. The second set of facets is defined by three second sides and three second cutting edges. Each second cutting edge is formed by adjacent ones of the three second sides, each second cutting edge forming a second angle with respect to the central longitudinal axis. The second angle is less than the first angle. The three second cutting edges meet to form a distal end of the biopsy needle. In an example, the biopsy needle is a 9-gauge (9-G) needle. In another example, the biopsy needle is a 7-gauge (7-G) needle. In yet another example, the first angle of the biopsy needle is in a range between about 17 degrees and about 23 degrees relative to the central longitudinal axis, and the second angle is in a range between about 9 degrees and about 15 degrees relative to the central longitudinal axis.

[0012] In another example, the diameter of the elongate body is greater than the diameter of the tissue-piercing tip. In another example, the elongate body includes a sidewall defining a lumen. In yet another example, the elongate body includes a tissue-receiving opening in the sidewall, the tissue-receiving opening being located adjacent the tissue-piercing tip at the distal end of the elongate body. In yet another example, the distance between the distal end point and the tissue-receiving opening defines a dead space, the dead space ranging from about 8 mm to about 11 mm. In one example, the first angle is about 20 degrees, the second angle is about 9 degrees, and the dead space is about 8.4 mm. In a second example, the first angle is about 20 degrees, the second angle is about 12 degrees, and the dead space is about 8.4 mm. In a third example, the first angle is about 20 degrees, the second angle is about 15 degrees, and the dead space is about 8.4 mm.

[0013] In a further example, all three first faces are symmetrical with respect to one another and all three first cutting edges are symmetrical with respect to one another. In an additional example, all three second faces are symmetrical with respect to one another and all three second cutting edges are symmetrical with respect to one another.

[0014] In another example, the tissue-penetrating tip includes one or more undulations. In yet another example, the tissue-penetrating tip includes three undulations extending along a central longitudinal axis, each of the undulations extending along a respective facet surface of the tissue-penetrating tip formed by a respective pair of first and second facets. In yet another example, each of the undulations forms a concave surface extending along the facet surface between the cutting edges, the concave surface being defined by a radius of curvature and a lateral length. In yet another example, the radius of curvature is between about 1.9 mm and about 3.7 mm, and the lateral length is between about 6.4 mm and about 8.3 mm.

[0015] In accordance with various additional example embodiments of the present disclosure, a biopsy needle set for penetrating soft tissue includes an outer cannula extending between a proximal end and a distal end. The outer cannula defines a central tube extending along a longitudinal axis. The outer cannula includes a tissue-piercing tip at a distal end of the outer cannula and includes a tissue-receiving opening adjacent the tissue-piercing tip. The tissue-piercing tip includes a first set of facets defined by three first sides and three first cutting edges. Each first cutting edge is formed by adjacent ones of the three first sides, each first cutting edge forming a first angle with respect to the longitudinal axis. The tissue-piercing tip also includes a second set of facets located distal to the first set of facets. The second set of facets is defined by three second sides and three second cutting edges. Each second cutting edge is formed by adjacent ones of the three second sides, each second cutting edge forming a second angle with respect to the longitudinal axis. The second angle is less than the first angle. The three second cutting edges meet to form a distal end point of the outer cannula. The biopsy needle set also includes an inner cannula disposed within a central lumen of the outer cannula. The inner cannula is configured to slide relative to the outer cannula to close the tissue receiving opening. In an example, the first angle is in a range between about 17 degrees and about 23 degrees relative to the longitudinal axis. In another example, the second angle is in a range between about 9 degrees and about 15 degrees relative to the longitudinal axis.

[0016] In another example, the inner cannula includes an open distal end surrounded by an annular cutting blade. In yet another example, the outer cannula includes a cutting plate disposed within the central lumen distal to the tissue receiving opening, the cutting plate configured to seal the open distal end of the inner cannula when the inner cannula contacts the cutting plate. In yet another example, the tissue penetrating tip includes one or more undulations. In yet another example, the tissue penetrating tip includes three undulations extending along the longitudinal axis, each of the undulations extending along a respective facet surface of the tissue penetrating tip formed by a respective pair of first and second facets. In yet another example, each of the undulations forms a concave surface extending along the facet surface between the cutting edges, the concave surface being defined by a radius of curvature and a lateral length. The radius of curvature is, for example, between about 1.9 mm and about 3.7 mm, and the lateral length is, for example, between about 6.4 mm and about 8.3 mm.

[0017] In an example, the biopsy device includes a body portion having a biopsy needle set attached thereto, the body portion including a drive assembly configured to drive movement of the outer cannula and the inner cannula of the biopsy needle set. In another example, the biopsy needle set is disposable. In yet another example, the first angle is in a range between about 17 degrees and about 23 degrees relative to the longitudinal axis, and the second angle is in a range between about 9 degrees and about 15 degrees relative to the longitudinal axis.

[0018] In accordance with various further example embodiments of the present disclosure, the multi-faceted soft tissue penetrating element comprises three distal planar cutting edges that meet to form a sharp distal point of the tissue penetrating element. Each distal cutting edge forms a first angle with respect to a central longitudinal axis of the tissue penetrating element. The tissue penetrating element also comprises three proximal planar cutting edges. Each proximal cutting edge extends proximally from a respective one of the three distal planar cutting edges. Each proximal cutting edge forms a second angle with respect to the longitudinal axis of the tissue penetrating element. The second angle is greater than the first angle. In examples, the first angle is in a range between about 9 degrees and about 15 degrees. In additional examples, the second angle is in a range between about 17 degrees and about 23 degrees.

[0019] In another example, the maximum diameter of the multi-surfaced tissue-piercing element is equal to or smaller than a 7-gauge (7-G) needle. In yet another example, three proximal planar cutting edges extend distally from the body of the biopsy needle or trocar. In yet another example, the multi-surfaced tissue-piercing element further includes three distal faces, each face located between two of the three distal planar cutting edges to form a distal pyramid of the tissue-piercing element. In yet another example, the multi-surfaced tissue-piercing element further includes three undulations, each undulation located between two of the three distal planar cutting edges.

[0020] Additional objectives and advantages will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the present teachings. At least some of the objectives and advantages of the present disclosure may be realized and attained by means of the elements and combinations particularly pointed out in the appended claims.

[0021] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the scope of the present disclosure and claims, including equivalents. It is to be understood that the present disclosure and claims in their broadest sense can be practiced without having one or more features of these exemplary aspects and embodiments. [Brief description of the drawings]

[0022] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate several exemplary embodiments of the disclosure and, together with the description, serve to explain certain principles. The drawings depict only typical embodiments of the disclosed invention and therefore should not be considered as limiting its scope. In the drawings:

[0023] [Figure 1] FIG. 1 is a partial isometric view of an exemplary embodiment of a needle having a distal tip formed in accordance with the present disclosure;

[0024] [Diagram 2] FIG. 2 is a partial top view of the needle of FIG.

[0025] [Diagram 3] FIG. 3 is a partial side view of the needle of FIG.

[0026] [Figure 4] FIG. 4 is an enlarged view of the distal tip of the needle of FIG.

[0027] [Diagram 5] FIG. 5 is a partial side view of another exemplary embodiment of a needle according to the present disclosure;

[0028] [Figure 6] FIG. 6 is a partial side view of yet another exemplary embodiment of a needle according to the present disclosure;

[0029] [Figure 7] FIG. 7 illustrates the relationship between the angle of the distal tip of the needle and the corresponding dead space of the needle;

[0030] [Figure 8]FIG. 8 is a partial bottom view of an alternative exemplary embodiment of the distal tip of the needle of FIG. 1, the distal tip including undulations in accordance with the present disclosure;

[0031] [Figure 9] FIG. 9 is a distal end view of the needle of FIG.

[0032] [Figure 10] FIG. 10 is a cross-sectional view of the needle of FIG. 8 taken from line AA of FIG. 9;

[0033] [Figure 11] FIG. 11 is a perspective view of an embodiment of a biopsy device incorporating an exemplary embodiment of a needle set comprising the needle of FIG.

[0034] [Figure 12] 12 and 13 are partial perspective views of the needle set of FIG. [Figure 13] 12 and 13 are partial perspective views of the needle set of FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0035] DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS As mentioned above, small gauge needles with larger lumen diameters have become the standard of care for breast biopsies. Smaller gauge needles can, for example, extract a larger amount of tissue and collect multiple samples consecutively without the need to remove the needle from the patient. Such biopsy techniques therefore improve the patient experience (i.e., by reducing the number of needle sticks required during a biopsy), while also reducing the risk of false negative results or underestimation of disease (i.e., more tissue can be collected during a biopsy procedure). However, it is generally more difficult to penetrate a patient's skin with such needles, as the penetration force required to insert the needle also increases with the size (i.e., diameter) of the needle. Therefore, in order to improve the functionality of biopsy devices and to improve the patient experience, it is desirable for biopsy needle designs, and in particular small gauge biopsy needle designs, to minimize the force required to insert the needle into a patient's soft tissue (i.e., designed to have a relatively small insertion force into the soft tissue). Sharper needles generally have lower insertion forces, therefore, exemplary embodiments of the present disclosure contemplate needle tip designs that result in sharp needles, and that can be used with both small and large gauge needles.

[0036] Embodiments of the present disclosure contemplate, for example, a distal needle tip portion having a multi-sided tissue-piercing element with three distal planar cutting edges that meet to form a sharp distal point and three proximal planar cutting edges extending proximally from a respective one of the three distal planar cutting edges. Each of the distal cutting edges may form a first angle with respect to a central longitudinal axis of the tissue-piercing element, and each proximal cutting edge may form a second angle with respect to the central longitudinal axis of the tissue-piercing element, the second angle being greater than the first angle. In this manner, a biopsy needle having a distal tip portion formed in accordance with the present disclosure has a multi-sided tissue-piercing (piercing) tip, whereby the cross-section of the biopsy needle is minimized at the distal tip. According to various exemplary embodiments, the present disclosure contemplates that the distal tip portion described herein may be used in, for example, biopsy needles, trocars, and needle sets, each having a distal tissue-piercing (piercing) tip with a first transition facet and a second piercing facet, the angle of the transition facet (first angle) being greater than the angle of the piercing facet (second angle). Additionally, the distal tip may include a plurality (or a set) of transition facets and a plurality (or a set) of piercing facets, the plurality of transition facets being located immediately adjacent to the plurality of piercing facets, the piercing facets being configured to form a distal end point of the distal tip of the biopsy needle to pierce (pierce) tissue of the skin of a patient. The distal needle tips described herein may be used with biopsy needles of any size (in other words, any gauge) and any form (e.g., any stylet, inner cannula, outer cannula, or trocar that can be used as a piercing tip) used to pierce or penetrate soft tissue, including (but not limited to) breast tissue.

[0037] In one embodiment, a contemplated multi-sided needle tip may be used in combination with a needle set that includes an elongated outer cannula or trocar that functions as a needle, and an inner cannula slidably disposed within the outer cannula. As described above, the elongated outer cannula has a tissue-penetrating tip and a tissue-receiving opening at a distal end, and the inner cannula has an open distal end surrounded by an annular cutting blade. In this manner, a physician may collect a tissue sample by (1) penetrating a patient's skin with the tissue-penetrating tip of the outer cannula, (2) positioning the receiving opening of the outer cannula so that tissue for collection escapes into the opening, and (3) sliding the inner cannula within the outer cannula to close the tissue-receiving opening, thereby severing the escaping tissue with the annular cutting blade of the inner cannula. Various known biopsy devices may utilize such needle sets, such as, for example, U.S. Patent No. 9,456,808, issued on October 4, 2016, entitled "Biopsy Device with Automatic Biopsy Parameter Adjustment," U.S. Patent No. 10,022,110, issued on July 17, 2018, entitled "Biopsy Device," and U.S. Patent No. 8,808,200, issued on August 19, 2014, entitled "Surgical Device and Method of Using the Same" (the entire contents of each of which are incorporated herein by reference).

[0038] FIG. 11 illustrates a biopsy device 10 according to one embodiment of the present disclosure. The biopsy device 10 includes a reusable body 12 and a disposable needle set 14. The body includes components configured to perform a needle biopsy using the needle set 14. These components may include, for example, a drive assembly configured to drive the movement of the components of the needle set 14. Exemplary drive systems are described in U.S. Pat. No. 10,022,110, issued July 17, 2018, entitled "Biopsy Device," and U.S. Pat. No. 11,045,172, issued June 29, 2021, entitled "Biopsy Device," each of which is incorporated herein by reference in its entirety. The drive assembly may include one or more motors known in the art, including, for example, electric, pneumatic, or hydraulic motors. The body 12 may also include a controller (e.g., a computer processor) configured to control the motors in the drive assembly, thereby controlling the movement of the components of the needle set 14.

[0039] 12 and 13 illustrate the distal portion of each of the needle sets 14. The needle set 14 includes an outer cannula or trocar 16 having a distal tissue-piercing tip 18 formed in accordance with the present teachings, and an inner cannula 26 having an open distal end 28 surrounded by an annular cutting blade 30. The outer cannula 16 defines an outer cannula lumen 24 and a tissue-receiving opening 20 in communication with the outer cannula lumen 24 adjacent the distal tissue-piercing tip 18. The inner cannula 26 is slidably disposed within the outer cannula lumen 24 such that the inner cannula 26 closes the tissue-receiving opening 20 of the outer cannula 16 when the inner cannula 26 is in its distal-most position within the outer cannula lumen 24. In this manner, during a biopsy procedure, the inner cannula 26 is configured to cut any tissue extending into the receiving opening 20 via the annular cutting blade 30 and to collect the cut tissue into the open distal end 28 as the inner cannula 26 closes the tissue receiving opening 20 of the outer cannula 16.

[0040] 13 (inner cannula 26 is not shown for clarity), in various example embodiments, a cutting plate 22 may also be positioned within outer cannula lumen 24 at a location distal to tissue-receiving opening 20. Cutting plate 22 is configured to seal open distal end 28 of inner cannula 26 when inner cannula 26 is in contact with cutting plate 22. This seal prevents fluid introduced into outer cannula lumen 24 from being aspirated through open distal end 28 and inner cannula lumen 32 and bypassing the biopsy site. Instead, the fluid is delivered to the biopsy site through outer cannula lumen 24 and tissue-receiving opening 20.

[0041] Other aspects of example biopsy devices are described in U.S. Patent No. 9,585,639, U.S. Patent No. 10,022,110, U.S. Patent No. 9,456,808, U.S. Patent No. 8,808,200, entitled "Biopsy Device Arming Mechanism," issued March 7, 2017, and U.S. Patent No. 9,844,363, entitled "Biopsy Device with Suction Valve," issued December 19, 2017. The above-referenced patent applications are assigned to the assignee of the present application and are hereby incorporated by reference in their entireties as if fully set forth herein.

[0042] Those skilled in the art will appreciate that the biopsy device 10 including the body 12 and needle set 14 described above and illustrated in Figures 11-13 is exemplary only, and that the multi-sided trocars, needle tips, and needles of the present disclosure may be used in conjunction with various types and forms of surgical instruments, biopsy devices, bodies / sleeves, stylets, needles, and needle sets used in various settings for various types of applications including, but not limited to, breast biopsy without departing from the scope of the present disclosure and claims. Those skilled in the art will also appreciate that the disclosed needle tips (e.g., distal tissue-piercing tips) may form the distal end of an outer cannula of a needle set and / or the distal end of an inner cannula of a needle set. Moreover, those skilled in the art will understand that the disclosed needles (e.g., cutting elements) and needle sets (e.g., needle set 14), including outer cannulas or trocars (e.g., outer cannula 16) and inner cannulas (e.g., inner cannula 26), can be made from a variety of high strength materials, including (but not limited to) surgical grade stainless steel, MP35N (a non-magnetic nickel-cobalt alloy), other cobalt-chromium alloys, NiTi alloys, ceramics, glass, high strength polymeric materials, and / or combinations thereof.

[0043] As would be understood by one of ordinary skill in the art in accordance with standard practice, embodiments of the present disclosure contemplate that the needle tips (e.g., trocars, stylets, cannulas) of the present disclosure may be used in conjunction with a variety of needles having various sizes and shapes (i.e., gauges and cross-sectional shapes), including needles having dimensions (e.g., widths and heights) corresponding to 7-gauge needles to 12-gauge needles. With respect to the embodiment of Figures 11-13, for example, the outer cannula 16 of the needle set 14 may have a relatively small gauge for biopsy procedures. In one exemplary embodiment of the present disclosure, the outer cannula 16 is a 7-gauge to 8-gauge needle with a lumen having a width w (see Figure 1), ranging in diameter from about 4.5 mm to about 5.6 mm, for example. It should be appreciated that the range of diameters (widths) may incorporate not only variations in the cross-sectional shape of the needle, but also variations between the inner and outer diameters of the needle. In another exemplary embodiment, the outer cannula 16 is a 9-gauge to 10-gauge needle with a lumen having a width w ranging from about 3.3 mm to about 4 mm. In yet another exemplary embodiment, the outer cannula 16 is an 11-gauge to 12-gauge needle with a lumen having a width w ranging from about 2.6 mm to about 3.0 mm. In various exemplary embodiments, the cross-sectional shape of the needle may vary, for example, it may be circular or oval. However, one skilled in the art will further understand that needles (trocars, stylets, cannulas) and needle sets according to the present disclosure may have various gauges with various corresponding dimensions for use in conjunction with various types and forms of surgical instruments and biopsy devices for various types of applications, for example, based on the needle shape and manufacturer, without departing from the scope of the present disclosure and claims.

[0044] 1-4 illustrate one embodiment of a 7-gauge outer cannula or trocar 16 in accordance with the present disclosure. The outer cannula 16 comprises an elongate body 17 and a tissue-piercing tip 18. The elongate body 17 extends between a proximal end 34 and a distal end 36 of the outer cannula 16 such that the elongate body 17 defines a central longitudinal axis L of the cannula 16 (see FIGS. 1 and 11). The elongate body may, for example, comprise a sidewall 13 defining a lumen extending along the central longitudinal axis L, and the tissue-piercing tip 18 defines a distal end point 19 of the elongate body 17. Various embodiments contemplate an outer cannula having a length l extending along the central longitudinal axis ranging from about 8 mm to about 16 mm (see FIG. 11). However, the length l of the needle (or outer cannula) may vary depending on the compatibility of the needle with a particular manufacturer and sampling location (or location of the patient's lesion), as will be understood by those skilled in the art. As illustrated, for example, in FIG. 11, which refers to the proximal and distal ends 34 and 36 of the outer cannula or trocar 16, the terms "distal" and "proximal" refer to the orientation of a component relative to the device to which the outer cannula or trocar 16 is connected. In other words, with respect to FIG. 11, proximal means that the described component is located closer to the body 12 than another component, and distal means that the described component is located farther from the body 12 than another component.

[0045] 4, in order to reduce the insertion force of the outer cannula 16 (needle), the tissue-penetrating tip 18 of the outer cannula 16 is a multi-sided tip whereby the distal tip 18 comprises: 1) a first set of facets 25 defined by three first faces 35 and three first cutting edges 45, where adjacent faces 35 are connected to one another by the cutting edges 45, and 2) a second set of facets 27 distal to the first set of facets 25, defined by three second faces 37 and three second cutting edges 47, where adjacent faces 37 are connected to one another by the cutting edges 47. In this manner, each of the first cutting edges 45 is formed by adjacent faces 35 of the first three faces 35, and each of the second cutting edges 47 is formed by adjacent faces 37 of the second three faces 37. In various embodiments, as shown in Figure 4, all three first faces 35 and three second faces 37 are planar, such that all first cutting edges 45 and second cutting edges 47 are straight (planar) cutting edges, as described further below. In various additional embodiments, all three first faces 35 and three first cutting edges 45 are symmetrical with one another, and all three second faces 37 and three second cutting edges 47 are symmetrical with one another. In various additional embodiments, all three first faces 35 and three first cutting edges 45 are not necessarily symmetrical with one another, and all three second faces 37 and three second cutting edges 47 are not necessarily symmetrical with one another, such that the needle tip has different sized faces on either side of the cutting edge.

[0046] As further illustrated in FIG. 4, each of the first cutting edges 45 is a straight (planar) edge that forms a first angle θ1 with respect to the central longitudinal axis L (thereby creating the first face 35, each having a first tapered surface), and each of the second cutting edges 47 is a straight (planar) edge that forms a second angle θ2 with respect to the central longitudinal axis L (thereby creating the first face 37, each having a second tapered surface). The first angle θ1 is greater than the second angle θ2, which causes the three second cutting edges 47 to meet at a sharper point (in other words, at the distal end point 19 of the tissue-piercing tip 18) before the first cutting edges 45 would have met (in other words, when the tip 18 does not include the second set of facets). In this manner, the cross-section of the outer cannula 16 is minimized at the tissue-piercing tip 18. In other words, tissue-piercing tip 18 is designed with a first set of transition facets 25 and a second set of penetrating facets 27, where the angle θ1 of transition facets 25 is greater than the angle θ2 of penetrating facets 35, such that penetrating facets 27 form a pyramidal tip extending distally from transition facets 25. As illustrated in the embodiment of FIGS. 1-4, which shows outer cannula 16 having a first angle θ1 of about 20 degrees and a second angle θ2 of about 12 degrees, each first cutting edge 45 forms a first angle θ1 ranging between about 17 degrees and 23 degrees with respect to central longitudinal axis L (the full range of first angle θ1 is shown in dashed lines for illustrative purposes), and each second cutting edge 47 forms a second angle θ2 ranging between about 9 degrees and about 15 degrees with respect to central longitudinal axis L (the full range of second angle θ2 is shown in dashed lines for illustrative purposes).

[0047] Those skilled in the art will appreciate that the above-described outer cannula 16 illustrated in Figures 1-4 is exemplary only, and that an outer cannula (trocar or needle) according to the present disclosure may have a variety of designs and configurations, including various combinations of a first set of transition facets and a second set of piercing facets tapered at various combinations of first angle θ1 and second angle θ2, without departing from the scope of the present disclosure and claims. Figures 5 and 6, for example, contemplate several alternative embodiments of the present disclosure, with Figure 5 illustrating a multi-sided outer cannula 116 having a smaller second angle θ2 (resulting in a steeper pyramidal tip and sharper distal end point 119) compared to the cannula 16 of Figures 1-4, and Figure 6 illustrating a multi-sided outer cannula 216 having a larger second angle θ2 (resulting in a blunter distal end point 219) compared to the cannula 16 of Figures 1-4. Outer cannula 116 has a first set of transition facets 125 (each tapered at a first angle θ1 of about 20 degrees) and a second set of penetrating facets 127 (each tapered at a second angle θ2 of about 9 degrees), while outer cannula 216 has a first set of transition facets 225 (each tapered at a first angle θ1 of about 20 degrees) and a second set of penetrating facets 227 (each tapered at a second angle θ2 of about 15 degrees).

[0048] As mentioned above, it will also be understood by those skilled in the art that needle tips contemplated by the present disclosure may be used in conjunction with needles having various gauges, including (but not limited to) the 7-gauge needles discussed above, and also contemplates the use of such trocars with, for example, 8-gauge to 12-gauge needles. In one exemplary embodiment of the present disclosure, the outer cannula is a 7-gauge to 8-gauge needle, has a width W (see FIG. 4) ranging from about 4.4 mm to about 4.8 mm, and has a penetrating faucet having a first angle θ1 ranging from about 17 degrees to about 23 degrees and a second angle θ2 ranging from about 9 degrees to about 15 degrees. In another embodiment, the outer cannula is a 9-gauge to 10-gauge needle, has a width W ranging from about 3.1 mm to about 3.5 mm, and has a penetrating faucet having a first angle θ1 ranging from about 16 degrees to about 22 degrees and a second angle θ2 ranging from about 8 degrees to about 14 degrees. In yet another embodiment, the outer cannula is an 11-gauge to 12-gauge needle having a width W ranging from about 2.2 mm to about 2.6 mm with a penetrating faucet having a first angle θ1 ranging from about 13 degrees to about 15 degrees and a second angle θ2 of about 8 degrees to about 10 degrees.

[0049] Those skilled in the art will also appreciate that the tissue-penetrating tip of the outer cannula or trocar can be made from a variety of materials, including, for example, surgical stainless steel (e.g., 17-4 stainless steel). And, the transition facets and penetrating facets can be formed on the tissue-penetrating tip using a variety of known manufacturing methods and / or techniques, including, for example, by being sharpened (e.g., with a grinding wheel) into the tissue-penetrating tip. In various embodiments, the faces of the facets can then be electropolished to increase the sharpness of the cutting edge.

[0050] As mentioned above, using smaller gauge needles (needles with larger width / diameter) provides certain benefits, but generally it is more difficult to penetrate a patient's skin with such needles. This is because the penetration force required to insert the needle increases with the size (in other words, diameter) of the needle. Therefore, to minimize the force required to insert the needle into the patient's tissue, it is desirable for the first angle θ1 and the second angle θ2 of the tissue-penetrating tip to be relatively small. However, the angle selection also involves other considerations and factors including, for example, the dead space D created by the tissue-penetrating tip and the fragility of the tissue-penetrating tip. Without wishing to be bound by any theory, the inventors have discovered that (1) the above-mentioned range of the first angle θ1 allows the first set of transition facets to penetrate tissue without excessively increasing the dead space D of the outer cannula. In other words, the disclosed ranges create a transition at the distal tip of the outer cannula that results in an acceptable dead space D (as will be understood by those of skill in the art and further described below) without requiring the user to exert excessive penetration force to insert the outer cannula, and (2) the above-mentioned ranges of the second angle θ2 optimize the ability of the second set of piercing facets to penetrate tissue without making the distal end point of the outer cannula overly fragile.

[0051] As used herein, the term "dead space" refers to the distance D between the distal end point 19, 119, 219 of the outer cannula 16, 116, 216 and the distal edge 21, 121, 221 of the tissue receiving opening 20, 120, 220 (see Figs. 2, 5, and 6). As illustrated in Fig. 7, it is advantageous to minimize the dead space D when performing a biopsy of a suspicious breast lesion, for example, to allow access to tissue near the chest wall (in other words, closer to the surface of the skin). In other words, a smaller dead space D allows access to tissue closer to the chest wall. It has further been found that the dead space D is inversely correlated with the magnitude of the first angle θ1, and therefore also with the amount of insertion force required to penetrate the skin (e.g., the chest wall). Thus, with reference to FIG. 7, (1) a relatively small angle (angle 1) results in a relatively small insertion force F1 and a relatively large dead space D1, (2) a relatively medium angle (angle 2) results in a relatively medium insertion force F2 and a relatively medium dead space D2, and (3) a relatively large angle (angle 3) results in a relatively large insertion force F3 and a relatively large dead space D3.

[0052] The exemplary outer cannulas of FIGS. 1-6 (each having a set of first transition facets 25, 125, 225 tapered at a first angle θ1 of about 20 degrees for illustrative purposes) may each have an opening length A of about .79 inches (20 mm), resulting in a dead space D of about .33 inches (8.4 mm). Based on the present disclosure, a given application, and the sample location (e.g., proximity to the chest wall), one of skill in the art can select the second angle θ2 to achieve an acceptable dead space D. For example, in an exemplary embodiment of the present disclosure where the outer cannula is a 7-gauge to 8-gauge needle, the minimum acceptable dead space D may be about 9.5 mm to about 11 mm. And, in an embodiment where the outer cannula is a 9-gauge to 12-gauge needle, the minimum acceptable dead space D may be about 8 mm to about 9 mm.

[0053] As mentioned above, those skilled in the art will understand that the embodiments shown and described with respect to Figures 1-6 and 11-13 are merely exemplary and that the disclosed biopsy devices, needle tips, needle sets, stylets, and inner and outer cannulas may be modified and / or include additional features without departing from the scope of the present disclosure and claims. For example, it has also been discovered that the insertion force of a needle is related to the cross-sectional area of ​​the needle tip (e.g., tissue-penetrating tip 18). Thus, various additional embodiments of the present disclosure contemplate, for example, an outer cannula with a multi-sided tissue-penetrating tip (or other words, a needle tip) that includes undulations. As illustrated in Figures 8-10, in one embodiment, the tissue-penetrating tip 18 of the outer cannula 16 may include one or more undulations 50 extending along the central longitudinal axis L (three undulations 50 are shown in the embodiment of Figures 8-10 (see Figure 9)). In one embodiment, each of the undulations 50 extends along the facet surface 29 of the tip 18, which is formed by a respective pair of transition facets 25 and piercing facets 27. As discussed above, each surface 29 is created by two different angled surfaces (e.g., each transition facet tapers at a first angle θ1 and each penetrating facet tapers at a second angle θ2), and each undulation 50 creates a concave surface that extends along the facet surface 29 between the planar cutting edge 45 and the planar cutting edge 47. In this manner, each undulation 50 functions to remove material from the surface of the tissue-piercing tip 18 to reduce the cross-sectional area of ​​the tissue-piercing tip 18, and thereby reduce the force required for insertion of the tissue-piercing tip 18.

[0054] As best shown in the cross-sectional view of FIG. 10, in various embodiments, each undulation 50 can have a radius of curvature R that results in the undulation 50 with a lateral distance S (relative to the central longitudinal axis L). As shown in the top view of FIG. 9, in this embodiment, the removal of the three undulations 50 forms three planar cutting edge surfaces 49 (each formed by a respective pair of cutting edges 45 and 47), each having a width w of about .01 inch (.25 mm). Given the disclosed relationship of the cross-sectional area of ​​the needle tip to its insertion force, one of ordinary skill in the art will be able to select appropriate values ​​of radius of curvature R, lateral distance S, and cutting edge width w for a particular application. For example, a smaller value of S (e.g., only .03 inches) with correspondingly larger values ​​of R (e.g., up to 1.0 inch) and w (e.g., up to .05 inches) results in a smaller reduction in cross-sectional area and a corresponding reduction in insertion force. For example, in embodiments of the present disclosure in which the outer cannula is a 7-gauge to 8-gauge needle, the radius of curvature R may range from about 3.5 mm to about 3.7 mm and the lateral distance S may range from about 8.1 mm to about 8.3 mm. In embodiments in which the outer cannula is a 9-gauge to 10-gauge needle, the radius of curvature R may range from about 2.5 mm to about 2.7 mm and the lateral distance S may range from about 6.4 mm to about 6.6 mm. And in embodiments in which the outer cannula is an 11-gauge to 12-gauge needle, the radius of curvature R may range from about 1.9 mm to about 2.1 mm and the lateral distance S may range from about 6.4 mm to about 6.6 mm. However, one of ordinary skill in the art will appreciate that the multi-sided tissue-piercing tip contemplated by the present disclosure may include undulations with various configurations, positions, and / or dimensions without departing from the scope of the present disclosure and claims. EXAMPLES

[0055] Working Example

[0056] Illustrative examples of the needle tips and needle sets described herein are provided below. The needle tips and needle sets embodiments described herein may include any one or more, and any combination, of the clauses described below.

[0057] Clause 1. A biopsy needle set for penetrating soft tissue, comprising: an outer cannula extending between a proximal end and a distal end, the outer cannula defining a central lumen extending along a longitudinal axis, the outer cannula including a tissue-penetrating tip at a distal end of the outer cannula and a tissue-receiving opening adjacent the tissue-penetrating tip; a first set of facets defined by three first surfaces and three first cutting edges, each first cutting edge being formed by adjacent ones of the three first surfaces, each first cutting edge forming a first angle with respect to the longitudinal axis; a second set of facets distal to the first set of facets, the second set of facets being defined by three second faces and three second cutting edges, each second cutting edge being formed by an adjacent one of the three second faces, each second cutting edge forming a second angle with respect to the longitudinal axis, the second angle being less than the first angle, and the three second cutting edges meeting to form a distal end point of the outer cannula; an outer cannula comprising: an inner cannula disposed within a central lumen of the outer cannula, the inner cannula configured to slide relative to the outer cannula to close the tissue-receiving opening; Includes a biopsy needle set.

[0058] Clause 2. The biopsy needle set of clause 1, wherein the first angle is in a range between about 17 degrees and 23 degrees relative to the longitudinal axis.

[0059] Clause 3. The biopsy needle set of any of clauses 1-2, wherein the second angle is in a range between about 9 degrees and about 15 degrees relative to the longitudinal axis.

[0060] Clause 4. The biopsy needle set of any of clauses 1 to 3, wherein the inner cannula comprises an open distal end surrounded by an annular cutting blade.

[0061] Clause 5. The biopsy needle set of clause 4, wherein the outer cannula comprises a cutting plate disposed within the central lumen distal to the tissue receiving opening, the cutting plate configured to seal the open distal end of the inner cannula when the inner cannula is in contact with the cutting plate.

[0062] Clause 6. The biopsy needle set of any of clauses 1 to 5, wherein the tissue penetrating tip includes one or more undulations.

[0063] Clause 7. The biopsy needle set of clause 6, wherein the tissue-penetrating tip includes three undulating portions extending along the longitudinal axis, each of the undulating portions extending along a respective facet surface of the tissue-penetrating tip formed by a respective pair of the first and second facets.

[0064] Clause 8. The biopsy needle set of clause 7, wherein each of the undulations forms a concave surface extending along the facet surface between the cutting edges, the concave surface being defined by a radius of curvature and a lateral distance.

[0065] Clause 9. The biopsy needle set of clause 8, wherein the radius of curvature is between about 1.9 mm and about 3.7 mm, and the lateral distance is between about 6.4 mm and about 8.3 mm.

[0066] Section 10. A main body portion, Clause 10. The biopsy needle set of any of clauses 1-9 attached to a body portion, the body portion comprising a drive assembly configured to drive movement of an outer cannula and an inner cannula of the biopsy needle set. 13. A biopsy device comprising:

[0067] Clause 11. The biopsy device of clause 10, wherein the biopsy needle set is disposable.

[0068] Clause 12. The biopsy device of any of clauses 10-11, wherein the first angle is in a range between about 17 degrees and about 23 degrees relative to the longitudinal axis.

[0069] Clause 13. The biopsy device of clause 12, wherein the second angle is in a range between about 9 degrees and about 15 degrees relative to the longitudinal axis.

[0070] Clause 14. A multi-plane soft tissue penetrating element, three distal planar cutting edges that meet to form a sharp distal point of the tissue-piercing element, each distal cutting edge forming a first angle with respect to a central longitudinal axis of the tissue-piercing element; three proximal planar cutting edges, each of which extends proximally from a respective one of the three distal planar cutting edges, each of which forms a second angle with respect to a central longitudinal axis of the tissue-piercing element, the second angle being greater than the first angle; A multi-plane soft tissue penetrating element including:

[0071] Clause 15. The multi-faceted tissue-piercing element of clause 14, wherein the first angle is in a range between about 9 degrees and about 15 degrees.

[0072] Clause 16. The multi-surface tissue-piercing element of any of clauses 14-15, wherein the second angle is in a range between about 17 degrees and about 23 degrees.

[0073] Clause 17. The multi-surface tissue-piercing element of any of clauses 14-16, wherein a maximum diameter of the multi-surface tissue-piercing element is equal to or smaller than a 7-gauge (7-G) needle.

[0074] Clause 18. The multi-surface tissue penetrating element of any of clauses 14-17, wherein three proximal planar cutting edges extend distally from the body of the biopsy needle or trocar.

[0075] Clause 19. The multi-sided tissue-penetrating element of any of clauses 14 to 18, further comprising three distal surfaces, each surface being located between two of the three distal planar cutting edges to form a distal pyramid of the tissue-penetrating element.

[0076] Clause 20. The multi-surface tissue-piercing element of any of clauses 14-19, further comprising three undulating portions, each undulating portion being located between two of the three distal planar cutting edges.

[0077] Clause 21. A biopsy needle for penetrating soft tissue, comprising: an elongate body extending between a proximal end and a distal end, the elongate body having a central longitudinal axis; a tissue-penetrating tip at a distal end of the elongate body, the tissue-penetrating tip comprising: a first set of facets defined by three first surfaces and three first cutting edges, each first cutting edge being formed by adjacent ones of the three first surfaces, each first cutting edge forming a first angle with respect to the central longitudinal axis; a second set of facets distal to the first set of facets, the second set of facets being defined by three second surfaces and three second cutting edges, each second cutting edge being formed by adjacent ones of the three second surfaces, each second cutting edge forming a second angle with respect to the central longitudinal axis, the second angle being less than the first angle, and the three second cutting edges meeting to form a distal end point of the biopsy needle; Including, a biopsy needle.

[0078] Clause 22. The biopsy needle of clause 21, wherein the biopsy needle is a 9-gauge (9-G) needle.

[0079] Clause 23. The biopsy needle according to any one of clauses 21 to 22, wherein the biopsy needle is a 7-gauge (7-G) needle.

[0080] Clause 24. The biopsy needle of clause 23, wherein the first angle is in a range between about 17 degrees and about 23 degrees relative to the central longitudinal axis.

[0081] Clause 25. The biopsy needle of any of clauses 23-24, wherein the second angle is in a range between about 9 degrees and about 15 degrees relative to the central longitudinal axis.

[0082] Clause 26. The biopsy needle of any of clauses 21 to 25, wherein the diameter of the elongate body is greater than the diameter of the tissue-penetrating tip.

[0083] Clause 27. The biopsy needle of any of clauses 21-26, wherein the elongate body includes a sidewall defining a lumen.

[0084] Clause 28. The biopsy needle of clause 27, wherein the elongate body includes a tissue-receiving opening in the sidewall, the tissue-receiving opening being located adjacent the tissue-penetrating tip in the distal end of the elongate body.

[0085] Clause 29. The biopsy needle of clause 28, wherein a distance between the distal end point and the tissue-receiving opening defines a dead space, the dead space ranging from about 8 mm to about 11 mm.

[0086] Clause 30. The biopsy needle of clause 29, wherein the first angle is about 20 degrees, the second angle is about 9 degrees, and the dead space is about 8.4 mm.

[0087] Clause 31. The biopsy needle of any of clauses 29 to 30, wherein the first angle is about 20 degrees, the second angle is about 12 degrees, and the dead space is about 8.4 mm.

[0088] Clause 32. The biopsy needle of any of clauses 29 to 31, wherein the first angle is about 20 degrees, the second angle is about 15 degrees, and the dead space is about 8.4 mm.

[0089] Clause 33. The biopsy needle of any of clauses 21-32, wherein all three first faces are symmetrical to one another and all three first cutting edges are symmetrical to one another.

[0090] Clause 34. The biopsy needle of any of clauses 21 to 33, wherein all three second faces are symmetrical to one another and all three second cutting edges are symmetrical to one another.

[0091] Clause 35. The biopsy needle of any of clauses 21 to 34, wherein the tissue-penetrating tip includes one or more undulations.

[0092] Clause 36. A biopsy needle as described in clause 35, wherein the tissue-penetrating tip includes three undulating portions extending along the central longitudinal axis, each of the undulating portions extending along a respective facet surface of the tissue-penetrating tip formed by a respective pair of the first and second facets.

[0093] Clause 37. The biopsy needle of clause 36, wherein each of the undulations forms a concave surface extending along the facet surface between the cutting edges, the concave surface being defined by a radius of curvature and a lateral length.

[0094] Clause 38. The biopsy needle of clause 37, wherein the radius of curvature is between about 1.9 mm and about 3.7 mm and the lateral length is between about 6.4 mm and about 8.3 mm.

[0095] This disclosure has described some examples of the technology with reference to the accompanying drawings in which some possible examples are shown. However, other aspects may be embodied in many different forms and should not be construed as being limited to the examples described in this application. Rather, these examples are provided so that this disclosure will be thorough, complete and fully convey the scope of possible examples to those skilled in the art.

[0096] All numerical values ​​in this application, whether expressly stated or not, are presumed to be modified by the term "about." The term "about" generally refers to a range of numbers that one of ordinary skill in the art would consider equivalent to the recited value (in other words, having the same function or result). In many instances, the term "about" may include numbers that are rounded to the nearest significant figure.

[0097] The recitation of numerical ranges by endpoints includes all numbers within that range (eg, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0098] This description and the accompanying drawings illustrating exemplary embodiments should not be considered limiting. Various mechanical, compositional, structural, electrical, and operational changes may be made without departing from the scope of this description and the claims (including equivalents). In some instances, well-known structures and techniques have not been shown and described in detail so as not to obscure the disclosure. Furthermore, elements and their associated features that have been described in detail with respect to one embodiment may, whenever practical, be included in other embodiments where they are not specifically shown and described. For example, when an element is described in detail with respect to one embodiment and not with respect to another embodiment, the element may nevertheless be included in the other embodiment.

[0099] As used herein, the singular forms "a," "an," and "the," as well as any singular use of any word, are understood to include plural referents unless clearly and unambiguously limited to one referent. As used herein, the term "comprises" and grammatical variations thereof are intended to be open-ended, such that the recitation of items in a list does not constitute the exclusion of other similar items that may be substituted for or in addition to the listed items.

[0100] Additionally, the terminology of this description is not intended to limit the disclosure. For example, spatial terms such as "below," "lower," "lower," "above," "upper," "forward," "behind," and the like may be used to describe the relationship of one element or feature to another element or feature as illustrated in the orientation of the figures. These spatial terms are intended to encompass various positions and orientations of the device during use or operation in addition to the positions and orientations depicted in the figures. For example, an element described as "below" or "below" another element or feature would be "above" or "on" that other element or feature when the device in the figures is inverted. Thus, the exemplary term "below" can encompass both upper and lower positions and orientations. The device may be otherwise oriented (rotated 90 degrees or in other directions) and the spatial descriptors used herein interpreted accordingly.

[0101] Further modifications and alternative embodiments will be apparent to those skilled in the art in view of the disclosure of this application. For example, the system may include additional components omitted from the diagrams and description for clarity of operation. This description should therefore be construed as merely illustrative and is intended to teach those skilled in the art the general manner of carrying out the disclosed system and method. It should be understood that the various embodiments shown and described in this application should be considered as examples. Elements and materials and the arrangement of those elements and materials may be substituted for those shown and described in this application, parts and processes may be reversed, and certain features of the present teachings may be utilized independently, all as would be apparent to those skilled in the art after having the benefit of the description of this application. Changes may be made in the elements described herein without departing from the scope of the present disclosure.

[0102] It should be understood that the specific examples and embodiments described herein are non-limiting and that modifications to structure, dimensions, materials, and methodologies can be made without departing from the scope of the present disclosure. Other embodiments in accordance with the present disclosure will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only and are entitled to their full breadth (including equivalents).

Claims

1. an elongate body extending between a proximal end and a distal end, the elongate body having a central longitudinal axis; a tissue-piercing tip at the distal end of the elongate body; 1. A biopsy needle for penetrating soft tissue, comprising: a first set of facets defined by three first surfaces and three first cutting edges, each first cutting edge formed by adjacent ones of the three first surfaces, each first cutting edge forming a first angle with respect to the central longitudinal axis; a second set of facets distal to the first set of facets, the second set of facets being defined by three second surfaces and three second cutting edges, each second cutting edge being formed by an adjacent one of the three second surfaces, each second cutting edge forming a second angle with respect to the central longitudinal axis, the second angle being less than the first angle, and the three second cutting edges meeting to form a distal tip of the biopsy needle; A biopsy needle comprising:

2. The biopsy needle of claim 1, wherein the biopsy needle is a 9-gauge (9-G) needle.

3. The biopsy needle of claim 1 , wherein the biopsy needle is a 7-gauge (7-G) needle.

4. The biopsy needle of claim 1 , wherein the first angle is in the range of between about 17 degrees and about 23 degrees relative to the central longitudinal axis.

5. The biopsy needle of claim 1 , wherein the second angle is in the range of between about 9 degrees and about 15 degrees relative to the central longitudinal axis.

6. The biopsy needle of claim 1 , wherein the diameter of the elongate body is greater than the diameter of the tissue-piercing tip.

7. 10. The biopsy needle of claim 1, wherein the elongate body includes a sidewall defining a lumen and a tissue-receiving opening therein, the tissue-receiving opening located adjacent the tissue-piercing tip in the distal end of the elongate body.

8. The biopsy needle of claim 7 , wherein the distance between the distal end point and the tissue-receiving opening defines a dead space, the dead space ranging from about 8 mm to about 11 mm.

9. 9. The biopsy needle of claim 8, wherein the first angle is about 20 degrees, the second angle is about 9 degrees, and the dead space is about 8.4 mm.

10. 9. The biopsy needle of claim 8, wherein the first angle is about 20 degrees, the second angle is about 12 degrees, and the dead space is about 8.4 mm.

11. 9. The biopsy needle of claim 8, wherein the first angle is about 20 degrees, the second angle is about 15 degrees, and the dead space is about 8.4 mm.

12. The biopsy needle of claim 1 , wherein all three of the first faces are symmetrical to one another and all three of the first cutting edges are symmetrical to one another.

13. The biopsy needle of claim 1 , wherein all three of the second surfaces are symmetrical with respect to one another and all three of the second cutting edges are symmetrical with respect to one another.

14. The biopsy needle of claim 1 , wherein the tissue-penetrating tip comprises one or more undulations.

15. 15. The biopsy needle of claim 14, wherein the tissue-penetrating tip comprises three undulations extending along the central longitudinal axis, each of the undulations extending along a respective facet surface of the tissue-penetrating tip formed by a respective pair of first and second facets.

16. 16. The biopsy needle of claim 15, wherein each of the undulations defines a concave surface extending along the facet surface between the cutting edges, the concave surface being defined by a radius of curvature and a lateral extent.

17. 17. The biopsy needle of claim 16, wherein the radius of curvature is between about 1.9 mm and about 3.7 mm, and the lateral length is between about 6.4 mm and about 8.3 mm.

Images