US20160030014A1 - Exchangeable core biopsy needle - Google Patents

Abstract

The present disclosure provides a biopsy needle configured to maximize tissue sampling yield and further ensure collection of a cohesive unit of sampled tissue. The biopsy needle of the present disclosure provides a distinct cutting slot defined on one side of a distal portion of the needle. The side cutting slot is configured to collect a full core of tissue sample and keep the full core intact.

Description

CROSS REFERENCES TO RELATED APPLICATION
• The present application claims the benefit of and priority to U.S. Provisional Application No. 62/030,661, U.S. Provisional Application No. 62/030,670, and U.S. Provisional Application No. 62/030,681, all of which were filed on Jul. 30, 2014. This application is related to U.S. patent application Ser. No. ______, and U.S. patent application Ser. No. ______, both of which were filed on ______. The entire contents of each of the above applications are incorporated herein by reference.
FIELD OF THE INVENTION
• The present disclosure generally relates to biopsy devices, and, more particularly, to a biopsy needle configured for collecting tissue, fluid, and/or cell samples in conjunction with minimally-invasive procedures, such as endoscopic biopsy procedures.
BACKGROUND
• In the practice of medical diagnostics, it is often necessary to perform a biopsy to remove a sample of a patient's tissue or fluid for pathological study. For example, biopsies can be useful in diagnosing various forms of cancer and other diseases affecting a localized area of tissue. Biopsy procedures may be used to take tissue and/or fluid samples from muscles, bones and organs, such as the liver or lungs. In some instances, a biopsy sample may be obtained by invasive surgical procedures. However, minimally invasive biopsy procedures are often preferred, such as fine needle aspiration and fine needle biopsy because such procedures are less traumatic to the patient.
• Both fine needle aspiration (FNA) and fine needle biopsy (FNB) procedures rely on a needle for collecting the target sample. Biopsy needles are generally classified as being either an end cutting needle or a side cutting needle. An end cutting needle generally includes a hollow cannula having a beveled, circumferentially sharpened, open end at its distal portion. A stylet may be inserted into the hollow shaft of the cannula and extend flush with the open cutting edge of the cannula to close the open end. When the biopsy needle is inserted, the stylet generally functions to puncture the target site (e.g., tissue mass) where the biopsy specimen is to be taken. The stylet is then withdrawn and the cannula further inserted into the tissue mass, wherein the sharpened and beveled leading end is configured to cut tissue and collect the cut tissue into the open distal end of the cannula. A suction device may be applied to a proximal portion of the cannula so as to draw the tissue into the lumen of the cannula.
• Generally, the goal of FNA and/or FNB is to acquire sufficient tissue to allow a diagnosis to be made. Currently, different needle configurations are used to collect different sample types (e.g., intact multi-cell samples useful for histology, cells and fragments useful for cytology, etc.). However, many existing biopsy needles are inefficient when collecting samples. For example, with respect to end cutting needles, some current needle tip designs generally result in tearing of target tissue, which may result in a less than ideal core sample and unnecessary trauma to the surrounding tissue, which may cause further complications to the patient (e.g., internal bleeding, bruising, etc.) requiring further treatment. Side cutting needles suffer from the drawback of not effectively drawing a tissue sample of sufficient size into the notch on the cannula. Accordingly, samples extracted by such biopsy needles may not provide sufficient tissue to perform an adequate examination and thus frequently require additional biopsies to be taken. Additionally, such needles suffer from the disadvantage of having to be advanced into the desired tissue site such that the needle may possibly extend beyond the tissue site, thus resulting in the recovery of an inaccurate or non-usable tissue sample, or even resulting in injury to adjacent organs or structures due to such overpenetration.
• Additionally, some needles that obtain a full cylinder or “full core” of tissue have difficulty in withdrawing tissue and/or in maintaining the physical state of the tissue so as to provide an accurate assessment of tissue morphology. For example, some needles rely on scoring and/or mashing techniques during tissue collection, which may result in a damaged tissue sample. Depending on the diagnostics, physical characteristics of tissue, such as placement or orientation of cells or tissue, may be as important, or more important, than the chemical or biological characteristics (e.g. presence of malignant cells or by-products).
• Furthermore, current needle tip designs may be insufficient for biopsy of certain types of tissue. For example, some lesions are particularly fibrous (e.g., pancreatic lesions) and are difficult to penetrate. Some bevel designs, such as the standard beveled cutting end ofneedle100, may initially pierce a portion of the target lesion, but may then deflect off of, or drift, from the target lesion due to the inadequate tip design and/or inability to fully penetrate the lesion, which results in a poor tissue sample, and may even lead to damage to surrounding tissues or vital organs. Additionally, current bevel designs may merely shear off a portion of the target tissue and fail to collect some, or even all, of the sampled tissue within the lumen of the needle due to inadequate tip design.
SUMMARY
• The present disclosure provides biopsy needles configured to maximize tissue sampling yield and further ensure collection of a cohesive unit of sampled tissue. The biopsy needles of the present disclosure are able to overcome the drawbacks of current needles by providing a distinct tissue collection distal end configured to collect a full core of tissue sample and keep the full core intact. The distinct distal end may include a distinct side slot, a helical slot extending from an open distal end, or a distal cutting tip forming a coring feature.
• In certain aspects, the present disclosure provides a biopsy needle that includes an elongate tubular body having a longitudinal axis. The body includes a proximal portion having a proximal end, a distal portion having a distal end, an outer surface, and an inner surface defining a lumen extending along the longitudinal axis between the proximal and distal portions. The biopsy needle further includes a cutting slot defined on one side of the distal portion of the body and extending through the outer and inner surfaces and into the lumen of the body. The cutting slot includes a proximal cutting end and an opposing distal cutting end. The cutting slot further includes opposing sidewalls defined between the proximal and distal cutting ends and extending along a length of the body and parallel to the longitudinal axis. At least one of the proximal and distal cutting ends defines a concave shape, or notch, having a cutting edge configured to excise a sample material upon contact therewith so as to capture the sample material within the lumen of the body.
• By providing a slot with both proximal and distal cutting ends, the biopsy needle allows sample collection by movement of the needle in either proximal or distal directions. For example, the distal cutting end is configured to make contact with and excise a sample material upon movement of the needle body in a proximal direction along the longitudinal axis. Similarly, the proximal cutting end is configured to make contact with and excise a sample material upon movement of the needle body in a distal direction along the longitudinal axis. Furthermore, by providing at least one of the proximal and distal cutting ends with a concave shape (such as a V-shape), the cross-sectional area of the cutting slot is increased, effectively increasing the cutting surface area of the slot and the amount of sample material that can be collected within the slot. By increasing the effective cutting surface area, the biopsy needle of the present disclosure is able to guide tissue into the lumen in a controlled manner and maximize the amount of tissue harvested, particularly upon aspiration.
• In another aspect, the present disclosure provides a biopsy needle having an elongate tubular body having a longitudinal axis. The body includes an open proximal end, an open distal end, an outer surface, and an inner surface defining a lumen extending along the longitudinal axis between the proximal and distal ends. The needle further includes a cutting tip defined on the distal end of the body. The cutting tip includes first and second portions formed on opposing sides of the needle body and converging at a pointed end. The first portion of the cutting tip generally includes a coring element formed from a first set of bevel grind. The second portion of the cutting tip includes a side slot formed from a second set of bevel grinds. The coring element defines a cutting edge configured to excise sample material upon rotational movement of the needle body about the longitudinal axis so as to capture and draw the sample material within the lumen of the body.
• The cutting tip geometry of this biopsy needle provides a novel way of acquiring targeted tissue, particularly when performing a FNA procedure. For example, while advancing the needle into the targeted site, the needle tip pierces the tissue and, upon rotation of the needle body, the coring element of the cutting tip shears and draws the sample material within the lumen, thereby resulting in collection of a core sample targeted specimen, maximizing the amount of sample harvested as a vacuum is applied.
• In another aspect, the present disclosure provides an elongate tubular body having a longitudinal axis. The body includes a proximal portion having an open proximal end, a distal portion having an open distal cutting end, an outer surface, and an inner surface defining a lumen extending along the longitudinal axis between the proximal and distal portions. The needle further includes a cutting slot extending from the open distal end in a direction towards the proximal portion of the body. The cutting slot extends through the outer and inner surfaces and into the lumen of the body. The cutting slot includes opposing sidewalls that extend from a proximal surface of the open distal cutting end and terminate at a base wall. The cutting slot further includes a cutting edge defined on at least one of the opposing sidewalls and base wall. The cutting edge is configured to excise a sample material upon contact therewith so as to capture the sample material within the lumen of the body. In some embodiments, the cutting slot has a helical shape, such that the cutting edge of the cutting slot is configured to contact and excise and draw a sample material into the lumen upon rotational movement of the needle body about the longitudinal axis.
• The cutting tip geometry of this biopsy needle provides a novel way of acquiring targeted tissue, particularly when performing a FNA procedure. For example, while advancing the needle into the targeted site, the needle tip pierces the tissue and, upon rotation of the needle body, the helical cutting slot shears the sample material, thereby resulting in collection of a core sample targeted specimen, maximizing the amount of sample harvested as a vacuum is applied.
• In another aspect, the present disclosure includes a device for needle biopsy. The device includes an adjustable delivery handle system including a delivery handle, at least a portion of which comprises an inner lumen configured to receive one of a plurality of exchangeable needle subassemblies. The adjustable delivery handle system further includes a sheath coupled to a distal end of the handle and having a lumen in fluid communication with the inner lumen of the delivery handle. The device further includes a needle subassembly removably disposed within the inner lumen of the delivery handle and lumen of the sheath, the needle subassembly including an exchangeable biopsy needle. The exchangeable biopsy needle generally includes an elongate tubular body having a longitudinal axis. The needle body further includes a proximal portion having a proximal end, a distal portion having a distal end, an outer surface, and an inner surface defining a lumen extending along the longitudinal axis between the proximal and distal portions. At least one of the distal portion and distal end is configured to capture a sample material within the lumen of the needle during a biopsy procedure.
• In some embodiments, the exchangeable biopsy needle includes a cutting slot defined on at least the distal portion of the needle body, wherein the cutting slot extends through the outer and inner surfaces and into the lumen of the body. In one embodiment, the cutting slot includes a proximal cutting end, an opposing distal cutting end, and opposing sidewalls defined between the proximal and distal cutting ends and extending along a length of the body and parallel to the longitudinal axis. At least one of the proximal and distal cutting ends has a cutting edge configured to excise a sample material upon lateral movement of the needle body along the longitudinal access so as to capture the sample material within the lumen of the body. In another embodiment, the cutting slot generally extends from the distal end of the needle body in a direction towards the proximal portion of the needle body and is formed from opposing sidewalls extending from a proximal surface of the distal end and terminating at a base wall, the cutting slot having a helical shape. At least one of the opposing sidewalls and base wall defines a cutting edge configured to excise a sample material upon contact therewith so as to capture the sample material within the lumen of the body.
• In some embodiments, the exchangeable biopsy needle includes a cutting tip defined on the distal end of the needle body. The cutting tip generally includes first and second portions formed on opposing sides of the needle body and converging at a pointed end of the cutting tip, wherein the first portion includes a coring element defining a cutting edge configured to excise sample material upon rotational movement of the needle body about the longitudinal axis so as to capture and draw a core of sample material within the lumen of the needle body.
• In some embodiments, the exchangeable biopsy needle further includes a collet surrounding a portion thereof and has a diameter sufficient to prevent the needle from entirely passing through a distal end of the sheath of the adjustable delivery handle system. In some embodiments, the needle subassembly further includes a needle protector subassembly releasably coupled to the collet of the needle. The needle protector subassembly further includes a sheath for encasing at least the distal end of the needle upon withdrawal of the needle from the delivery handle and for preventing inadvertent cutting and/or puncturing. Furthermore, the sheath is moveable along a length of the needle body and configured to be retracted in a proximal direction to expose the distal end of the needle for removal of acquired tissue sample from the lumen of the needle.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a perspective view of a biopsy device including an adjustable delivery handle and sheath for receipt of and use with an exchangeable biopsy needle consistent with the present disclosure.
• FIG. 2 is a drawing of the needle sub-assembly of the device ofFIG. 1.
• FIG. 3 is a cross-sectional drawing of the needle protector embodiment of the needle sub-assembly ofFIG. 2.
• FIG. 4 is a cross-sectional drawing of the proximal end of the biopsy needle sub-assembly ofFIG. 2.
• FIG. 5 is a perspective view of a distal portion of biopsy needle consistent with the present disclosure.
• FIG. 6 is a bottom view of the distal portion of the biopsy needle ofFIG. 5.
• FIG. 7 is a top view of the distal portion of the biopsy needle ofFIG. 5.
• FIG. 8 is a side profile view of the distal portion of the biopsy needle ofFIG. 5.
• FIG. 9 is a bottom view of a distal portion of another embodiment of a biopsy needle consistent with the present disclosure.
• FIG. 10 is a side profile view of a distal portion of another embodiment of a biopsy needle consistent with the present disclosure.
• FIG. 11 is a bottom view of a distal portion of another embodiment of a biopsy needle consistent with the present disclosure.
• FIG. 12 is a side profile view of a distal portion of another embodiment of a biopsy needle consistent with the present disclosure.
• FIG. 13 is a perspective view of the biopsy needle ofFIG. 5 including a collet consistent with the present disclosure.
• FIG. 14A is a side view, partly in section, of storage of the biopsy needle ofFIG. 13 within the sheath ofFIG. 1.
• FIG. 14B is a side view, partly in section, of extension of the biopsy needle ofFIG. 13 from the sheath ofFIG. 1.
• FIG. 15 illustrates the biopsy needle ofFIG. 5 inserted into a sample tissue for collection of a portion of the sample tissue.
• FIG. 16 is an enlarged side view, partly in section, illustrating a sample tissue collection procedure using the biopsy needle ofFIG. 5 consistent with the present disclosure.
• FIG. 17 is an enlarged side view, partly in section, illustrating a sample tissue collection procedure using the biopsy needle ofFIG. 5 consistent with the present disclosure.
• FIG. 18 is a perspective view of a portion of another embodiment of a biopsy needle consistent with the present disclosure.
• FIG. 19 is a perspective view of a portion of another embodiment of a biopsy needle consistent with the present disclosure.
• FIG. 20 is a side profile view of the distal end of the biopsy needle ofFIGS. 18 and 19.
• FIG. 21 illustrates the biopsy needle ofFIGS. 18-20 inserted into a sample tissue for collection of a portion of the sample tissue.
• FIG. 22 is an enlarged perspective view illustrating the initiation of sample tissue collection with the biopsy needle ofFIGS. 18-20 consistent with the present disclosure.
• FIG. 23 is a perspective view of a portion of another embodiment of a biopsy needle consistent with the present disclosure.
• FIG. 24 is a side profile view of the distal end of the biopsy needle ofFIG. 23.
• FIG. 25 illustrates the biopsy needle ofFIGS. 23-24 inserted into a sample tissue for collection of a portion of the sample tissue.
• FIG. 26 is an enlarged perspective view illustrating the initiation of sample tissue collection with the biopsy needle ofFIGS. 23-24 consistent with the present disclosure.
DETAILED DESCRIPTION
• By way of overview, the present disclosure is generally directed to a biopsy needle configured for collecting tissue, fluid, and/or cell samples in conjunction with minimally-invasive procedures, such as endoscopic biopsy procedures. As described in greater detail herein, a biopsy needle consistent with the present disclosure may be used in Endoscopic Ultrasound (EUS) and Endobronchial Ultrasound (EBUS) procedures, particularly EUS Fine Needle Aspiration (FNA), EUS Fine Needle Biopsy (FNB), EUS Coring, and EBUS procedures for the purpose of harvesting tissue specimen from a targeted site. It should be noted, however, that the biopsy needle may be used in other minimally-invasive procedures, and is not limited to EUS and/or EBUS procedures.
• A side cutting needle, sometimes referred to as a TRU-CUT needle, generally includes an inner cannula slidably positioned within an outer cannula. The inner cannula generally has a leveled, circumferentially sharpened distal end shaped to a pointed end with a notch formed at a distal portion of the inner cannula proximate to the pointed end. During a biopsy procedure, the side cutting needle is advanced to the target site (e.g., tissue mass) where the biopsy specimen is to be taken. In some instances, a suction device may be applied to a proximal portion of the inner cannula so as to draw tissue into the notch. At this point, the outer cannula may be advanced over the inner cannula. The outer cannula can have a cutting edge formed about its opening, such that advancement of the cutting edge past the notch of the inner cannula severs the tissue within the notch, thereby encapsulating the tissue sample within. Alternatively, the notch of the inner cannula may include a cutting edge, such that the inner cannula may be rotated or translated in a longitudinal direction so that the cutting edge of the notch severs the tissue specimen. The outer cannula may then be advanced over the inner cannula so as to encapsulate the specimen there between.
• In one aspect, the present disclosure provides a biopsy needle that generally includes an elongate tubular body having a longitudinal axis. The body includes a proximal portion having a proximal end, a distal portion having a distal end, an outer surface, and an inner surface defining a lumen extending along the longitudinal axis between the proximal and distal portions. The biopsy needle further includes a cutting slot defined on one side of the distal portion of the body and extending through the outer and inner surfaces and into the lumen of the body. The cutting slot includes a proximal cutting end and an opposing distal cutting end. The cutting slot further includes opposing sidewalls defined between the proximal and distal cutting ends and extending along a length of the body and parallel to the longitudinal axis. At least one of the proximal and distal cutting ends defines a concave shape, or notch, having a cutting edge configured to excise a sample material upon contact therewith so as to capture the sample material within the lumen of the body.
• By providing a slot with both proximal and distal cutting ends, the biopsy needle allows sample collection by movement of the needle in either proximal or distal directions. For example, the distal cutting end is configured to make contact with and excise a sample material upon movement of the needle body in a proximal direction along the longitudinal axis. Similarly, the proximal cutting end is configured to make contact with and excise a sample material upon movement of the needle body in a distal direction along the longitudinal axis. During this process, the tissue is excised by the cutting edge, creating a contiguous core biopsy sample.
• Furthermore, by providing at least one of the proximal and distal cutting ends with a concave shape (such as a V-shape), the cross-sectional area of the cutting slot is increased when compared to conventional side-cutting needles, effectively increasing the cutting surface area of the slot and the amount of sample material that can be collected within the slot. By increasing the effective cutting surface area, the biopsy needle of the present disclosure is able to guide tissue into the lumen in a controlled manner and maximize the amount of tissue harvested, particularly upon aspiration.
• In another aspect, the present disclosure provides a biopsy needle having an elongate tubular body having a longitudinal axis. The body includes an open proximal end, an open distal end, an outer surface, and an inner surface defining a lumen extending along the longitudinal axis between the proximal and distal ends. The needle further includes a cutting tip defined on the distal end of the body. The cutting tip includes first and second portions formed on opposing sides of the needle body and converging at a pointed end. The first portion of the cutting tip includes a side slot formed from a first set of bevel grinds and the second portion of the cutting tip includes a coring element formed from a second set of bevel grinds. The coring element defines a cutting edge configured to excise sample material upon rotational movement of the needle body about the longitudinal axis so as to capture and draw the sample material within the lumen of the body. During this process the tissue is excised by the cutting edge, creating a contiguous core biopsy sample.
• The cutting tip geometry of this biopsy needle provides a novel way of acquiring targeted tissue, particularly when performing a FNA procedure. For example, while advancing the needle into the targeted site, the needle tip pierces the tissue and, upon rotation of the needle body, the coring element of the cutting tip shears the sample material, thereby resulting in collection of a core sample targeted specimen, maximizing the amount of sample harvested as a vacuum is applied.
• In another aspect, the present disclosure provides an elongate tubular body having a longitudinal axis. The body includes a proximal portion having an open proximal end, a distal portion having an open distal cutting end, an outer surface, and an inner surface defining a lumen extending along the longitudinal axis between the proximal and distal portions. The needle further includes a cutting slot extending from the open distal end in a direction towards the proximal portion of the body. The cutting slot extends through the outer and inner surfaces and into the lumen of the body. The cutting slot includes opposing sidewalls that extend from a proximal surface of the open distal cutting end and terminate at a base wall. The cutting slot further includes a cutting edge defined on at least one of the opposing sidewalls and base wall. The cutting edge is configured to excise a sample material upon contact therewith so as to capture the sample material within the lumen of the body. In some embodiments, the cutting slot has a helical shape, such that the cutting edge of the cutting slot is configured to contact and excise and draw a sample material into the lumen upon rotational movement of the needle body about the longitudinal axis. During this process the tissue is excised by the cutting edge, creating a contiguous core biopsy sample
• The cutting tip geometry of this biopsy needle provides a novel way of acquiring targeted tissue, particularly when performing a FNA procedure. For example, while advancing the needle into the targeted site, the needle tip pierces the tissue and, upon rotation of the needle body, the helical cutting slot shears the sample material, thereby resulting in collection of a core sample targeted specimen, maximizing the amount of sample harvested as a vacuum is applied.
• The distinct sample collecting distal ends of biopsy needles consistent with the present disclosure are configured to collect a full core of tissue sample while keeping the full core intact. Accordingly, biopsy needles consistent with the present disclosure are configured to maximize tissue sampling yield and further ensure collection of a cohesive unit of sampled tissue so as to provide a more complete sample for testing, which may improve the accuracy and/or timing of diagnosis.
• The biopsy needle of the present disclosure may be used in conjunction with minimally-invasive procedures, such as endoscopic biopsy procedures. For example, the biopsy needle may be compatible with an endoscopic biopsy device, such as needle biopsy delivery device configured for endoscopic ultrasound or endoscopic bronchial ultrasound procedures. For example, the biopsy needle may be compatible for use with exemplary endoscopic deliver systems and methods discussed in Needle Biopsy Device with Exchangeable Needle and Integrated Needle Protection, U.S. Pub. 2012/0116248, Rapid Exchange FNA Biopsy Device with Diagnostic and Therapeutic Capabilities, U.S. Pub. 2011/0190662, Device for Needle Biopsy with Integrated Needle Protection, U.S. Pub. 2010/0121218, and Needle Biopsy Device, U.S. Pub. 2010/0081965, the contents of each of which are hereby incorporated by reference in their entirety.
• An exemplary embodiment of an endoscopic delivery device for use with a biopsy needle of the present disclosure is illustrated inFIG. 1. The device and specific delivery methods are discussed in more detail in Needle Biopsy Device with Exchangeable Needle and Integrated Needle Protection, U.S. Pub. 2012/0116248, the contents of which are hereby incorporated by reference in their entirety. The device design consists of a handle mechanism (delivery system handle10) andremovable needle sub-assembly15. The delivery system handle10 includes aproximal handle member10a, amiddle handle member10b, and adistal handle member10c. The proximal, middle and distal handle members each include an inner lumen and are coupled together to define a longitudinal axis such that the inner lumens are in constant communication and extends throughout the length of the coupled handle members.Proximal handle member10ais slideably disposed over at least a portion of themiddle handle member10b, andmiddle handle member10bis slideably disposed over at least a portion ofdistal handle member10c. Theproximal handle member10aincludesproximal handle grip10a1 adistal handle grip10a2. The delivery handle system10 further includes an inner handle member10ddisposed within the inner lumen of themiddle handle member10b.
• The delivery system handle10 also incorporates asheath14 component coupled to the distal end of thedistal handle member10c. This component provides a conduit between the delivery system handle10 and the target sampling site during the exchange of needles, such as the biopsy needle previously described herein. The device design is modular in that theneedle sub-assembly15 can be detached from theproximal handle10aof the device for each individual “pass” or aspirated sample taken by the endoscopist at the site of the lesion or abnormality.
• The delivery system handle10 incorporates two length adjustment features actuated via adjustment of two thumbscrew locking mechanisms. A threadedproximal thumbscrew12 and lockingring33 are moveably disposed around themiddle handle member10b, theproximal thumbscrew12 is loosened to loosen lockingring33, lockingring33 is moved distally along themiddle handle member10band tightened in the desired position alongmiddle handle member10bviaproximal thumbscrew12 to allow the user to establish a set depth of needle penetration beyond the end of thesheath14. A threadeddistal thumbscrew13 is transversely disposed at the distal portion of themiddle handle member10b, thedistal thumbscrew13 is loosened to move themiddle handle member10bdistally and/or proximally and tightened to allow the user to establish a set depth ofsheath14 extension beyond the end of the endoscope accessory channel.
• Theneedle sub-assembly15 consists of at least a biopsy needle consistent with the present disclosure (e.g., needle100). Thebody102 ofneedle100 can range in length from 200 mm up to 2500 mm. In some embodiments, theneedle body102 can range in length between 500 mm to 2000 mm. In some embodiments, theneedle body102 can range in length between 800 mm to 1800 mm. In some embodiments, theneedle body102 can range in length between 1640 mm to 1680 mm. Theneedle sub-assembly15 further includesneedle hub17,needle luer18,needle collet105,needle protector sub-assembly9,stylet hub20, andstylet shaft22.
• As generally understood, theneedle100 itself can be manufactured from a variety of metallic based materials, including, but not limited to, nitinol, cobalt chrome, stainless steel, a metal alloy, combinations thereof, nanotube composites, including materials such as carbon, silicon, boron nitride, inorganic materials, or combinations thereof, or polymeric based materials including, but not limited to poly-ether-ether ketone, polyamide, poyethersulfone, polyurethane, ether block amide copolymers, polyacetal, polytetrafluoroethylene and/or derivatives thereof. It should be noted that the biopsy needle is not limited to any particular gauge (e.g., outer diameter). For example, depending on the type of sample to be collected, as well as the target site from which the sample is to be collected, the biopsy needle may range from 10-gauge to 30-gauge, and more specifically 15-gauge to 28-gauge, i.e.,gauge 12, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, or 25 needles.
• FIG. 2 is a drawing of theneedle sub-assembly15 of the device ofFIG. 1. The sub-assembly15 is inserted into and removed from the lumen of the delivery system handle10 in acquiring tissue samples. The sub-assembly15 consists ofstylet hub20 andstylet shaft22 components which are securely locked on theneedle luer18 of theneedle100 via conventional internal luer threads, as generally understood by one skilled in the art. Thestylet hub20 may be attached to thestylet shaft22 via any known processing techniques, including, but not limited to, adhesive bonding or insert injection molding. The female luer of theneedle100 incorporates a mating luer thread detail, onto which thestylet hub20 may be tightened. Theneedle luer18 element of the present disclosure may be attached to the proximal end of the needle shaft via a number of processing techniques such as adhesive bonding or insert injection molding.
• Theremovable needle sub-assembly15 also incorporates aneedle collet105. The function of thisneedle collet105 is to provide a means to center theneedle body102 in thesheath14 of the delivery system during needle exchange and provide a mechanism for securing and locking the needle protector sub-assembly to thedistal end104needle100 once theneedle100 has been unlocked and withdrawn from the delivery system handle. Theneedle collet105 of the present disclosure may be attached to a portion of theneedle body102 near thedistal end104 of theneedle100 by way of any known processing techniques, including, but not limited to, adhesive bonding, laser welding, resistance welding, insert injection molding, and combinations thereof. Theneedle collet105 may be fabricated from metals materials such as stainless steel, nickel titanium or alloys thereof or polymer materials such as, but not limited to, polyacetal, polyamide, poly-ether-block-amide, polystyrene, acrylonitrile butadiene styrene or derivatives thereof.
• FIG. 3 illustrates theneedle protection sub-assembly9 design embodiment of the present disclosure in the locked position at thedistal end104 of theneedle100. Theneedle protection sub-assembly9 consists of two needle protector (NP) hub halves (collectively23), which are adhesively bonded to each other, on the proximal end of the needle protector (NP)sheath component24. Alternatively, the NP hub halves23 may be snap fit together or may be insert injection molded over theNP sheath24 to provide a secure bond/attachment between these components in the assembly. Theneedle protection sub-assembly9 also incorporates a needle protector (NP) hub O-Ring component25. The O-Ring component resides in a recessed cut-out in the center of the assembled NP hub halves23. The NP hub O-Ring25, in conjunction with theneedle collet105, which is securely attached to a portion of theneedle body102 near thedistal end104 of theneedle100, provides a mechanism for locking theNP sub-assembly9 onto the end of theneedle100. In this way, thedistal end104, including the pointed tip (described in greater detail herein), is protected, covered and shielded once the needle has been removed from the delivery system handle.
• For example, upon acquiring a sample from a target site, theneedle100 may be removed so as to gain access to the sampled material for testing and diagnostic procedures. Theneedle100 may be continually withdrawn from the delivery system handle10, such that theneedle collet105 contacts the NP hub O-ring25 and further pulls theNP sub-assembly9 from engagement withneedle hub17, such that theneedle100 is completely removed from the delivery system handle10 and theNP sheath24 encases thedistal end104 of theneedle100 to prevent inadvertent “needle sticking”. Further, an operator may then pull back theNP sub-assembly9 from thedistal end104 of theneedle100 so as to collect the sampled material stored within the lumen of theneedle100. Accordingly, theNP sub-assembly9 is configured to translate along a length of theneedle100 so as to allow access to thedistal end104 of theneedle100 post acquisition and when theneedle100 is entirely removed from the delivery system handle10.
• FIG. 4 illustrates theneedle hub17 embodiment of the needle sub-assembly. Theneedle hub17 provides a mechanism configured to lock theremovable needle sub-assembly15 into the delivery system handle10 by means of the hub housing27 andthumb latch28 components and provides a means to lock theneedle protection sub-assembly9, shown inFIG. 3, into the delivery system device handle10. As shown, theneedle hub component17 is securely attached to theneedle luer18 andneedle body102. Theneedle hub element17 of the present disclosure may be attached to the distal end of theneedle luer component18 via a number of processing techniques such as adhesive bonding or insert injection molding.
• In some embodiments, manipulation of theneedle hub17 may cause rotation at thedistal end104 of theneedle100. As described in greater detail herein, the distal end of biopsy needles consistent with the present disclosure may have a distinct cutting configuration configured to excise and biopsy a sample material upon rotational movement. Accordingly, upon rotation of theneedle hub17, the distal end of the needle rotates, resulting in collection of a sample material. In some embodiments, theneedle hub17 may be disengaged from the handle10 by depressing thethumb latch28 and detached from theproximal handle10amember so as to allow an operator to rotate theneedle hub17 to cause rotation of the distal end of the needle for sample collection. In other embodiments, theneedle hub17 may be configured to rotate while remaining coupled to the handle10. In some embodiments, theneedle hub17 and/or handle10 may include a mechanism for providing an operator with control over the rotational movement of theneedle hub17 and, in turn, the distal end of the needle. Theneedle hub17 and/or handle10 may further include a feature configured to indicate gradation of rotational movement. For example, in one embodiment, theneedle hub17 and/or handle10 may include a feature configured to allow the operator to rotate theneedle hub17 in distinct intervals and further provide an audible indication of needle rotation at specific intervals (e.g., provide a clicking sound every ⅛, ¼, ½, etc. of a rotation about a longitudinal axis of the needle body), thereby providing the operator improved control when performing the biopsy procedure. For example, a customizable dial element may be provided which may be configured to limit rotation of theneedle hub17 to a desired setting. Other elements may be included for controlling rotation theneedle hub17, as generally understood by one skilled in the art.
• In some instances, it may be preferable to switch needles during a procedure, while still maintaining access to the target site. The delivery system ofFIG. 1 is configured to allow rapid needle exchanges without requiring the delivery system to be removed from the scope, as described in greater detail in U.S. Pub. 2012/0116248, the contents of which are hereby incorporated by reference in their entirety. The rapid needle exchange capabilities provided by the delivery system of the present disclosure may further decrease the amount of time required for a biopsy procedure, which may cut down the amount of anesthesia required during a particular procedure, improving patient safety. Additionally, a new biopsy device is not required for each needle, as may be the case with current biopsy devices and techniques. Accordingly, the delivery system and exchangeable needles of the present disclosure can cut down on costs and by preventing unnecessary waste.
• It should be noted that any one of the embodiments of biopsy needles consistent with the present disclosure can be used with the delivery system ofFIG. 1 and need not be limited tobiopsy needle100.
• FIGS. 5-8 depict one embodiment of abiopsy needle100 consistent with the present disclosure.FIG. 5 is a perspective view of a distal portion ofbiopsy needle100 consistent with the present disclosure.FIGS. 6-8 are bottom, top, and side profile views of the distal portion of the biopsy needle ofFIG. 5. As shown, theneedle200 generally includes an elongatetubular body102 having a longitudinal axis X. Thebody102 includes a proximal portion having a proximal end103 (shown inFIG. 3), a distal portion having adistal end104, an outer surface, and an inner surface defining alumen108 extending along the longitudinal axis X between the proximal and distal portions. Theneedle100 further includes acutting slot106 defined on one side of the distal portion of thebody102. The cuttingslot106 generally extends through the outer and inner surfaces and into thelumen108 of thebody102. As described in greater detail herein, the cuttingslot106 is configured for collection and harvesting of a sample material, including, but not limited to, tissue, fluid, and/or cell samples. In particular, the cutting slot has a distinct shape so as to enhance the ability of theneedle100 to collect tissue during sample acquisition.
• As shown, the cuttingslot106 includes aproximal cutting end110 and an opposingdistal cutting end112 and opposingsidewalls114a,144bdefined between the proximal and distal cutting ends110,112. The opposingsidewalls114a,114bgenerally extend along a length of thebody102 and are parallel to the longitudinal axis X. At least one of the proximal and distal cutting ends110,112 and the opposingsidewalls114a,114bincludes a cutting edge for excising sample material (e.g., tissue) upon contact therewith during biopsy procedure. For example, as shown inFIG. 8, at least the proximal and distal cutting ends110,112 each define acutting edge124,126, respectively, such that lateral movement of theneedle100 along the longitudinal axis X in both proximal and distal directions may result in the excision of tissue during a biopsy material (shown inFIGS. 15 and 16).
• In some embodiments, thedistal end104 of theneedle body102 may be open, such that the proximal anddistal ends103,104 are in fluid communication with one another via thelumen108. It should be noted, however, that in some embodiments, thedistal end104 is closed. In the illustrated embodiment, the opendistal end104 is formed from a set of distinct angular bevel grinds oblique to the outer surface of thebody102. The set of angular bevel grinds may include afirst bevel grind120 extending from aproximal surface121 of thedistal end104 and towards apointed tip116, asecond bevel grind122 extending from thefirst bevel grind120 and terminating at thepointed tip116, and a back-cut bevel grind118 oblique to first and second bevel grinds120,122 and the outer surface of thebody102 and proximate to thepointed tip116 for providing a smooth needle passage during needle insertion and withdrawal during a biopsy procedure. For example, back-cut grind118 has a back-cut angle A in the range of 15 degrees to 70 degrees relative to the outer surface of thebody102, but more preferably in the range of 25 degrees to 45 degrees. In one embodiment, the back cut angle A is 30 degrees.
• Thepointed tip116 formed fromsecond bevel grind122 and the back-cut grind118 may be configured to make contact with and pierce a sample material during a biopsy procedure so as to gain access to a target site and/or excise a sample material, particularly with the aid of aspiration.
• The inclusion of at least back-cut grind118 on thedistal end104 may ensure the smooth passage of the needle down a sheath, or other enclosure of a delivery device, during needle movement and/or exchange. For example, as previously described, thebiopsy needle100 of the present disclosure may be used in conjunction with a delivery device, such as the delivery system ofFIG. 1. The endoscopic device may generally include a sheath, or other enclosure, to provide theneedle100 with access to a target site for tissue collection. As such, during a needle exchange, for example, it is important that theneedle100 can be passed through an internal diameter of a sheath of the delivery device without catching on an internal wall of same. As the needle advances, the heel of the back-cut grind118 may come in contact with the internal diameter of the sheath and reduce the friction between thedistal end104 of theneedle100, particularly the pointedtip116 and the sheath. In this way, theneedle100 can be smoothly tracked through the sheath to exit the end of the sheath. This feature also makes it easy to remove a needle and re-insert a new needle while the rest of a delivery device remains within a patient during a procedure.
• Alternative embodiments of biopsy needles200,300 are generally illustrated inFIGS. 9-12. For example,FIGS. 9 and 10 are bottom and side profile views ofbiopsy needle200 having an alternative embodiment of acutting slot206. In the illustrated embodiment, thedistal cutting end210 of thecutting slot206 defines a concave shape, generally in a V-shape or a notch. Accordingly, thecutting edge226 of thedistal cutting end212 has an acute cutting angle. The particular concave shape generally results in an increase in the cross-sectional area of thecutting slot206, particularly when compared to conventional side-cutting needles, effectively increasing the cutting surface area of theslot206 and the amount of sample material that can be collected within theslot206.
• FIGS. 11 and 12 are bottom and side profile views ofbiopsy needle300 having an alternative embodiment of acutting slot306. In this embodiment, both the proximal and distal cutting ends310,312 of thecutting slot306 have a concave shape, generally in a V-shape or notch. As such, the cross-sectional area of thecutting slot306 ofneedle300 is further increased, effectively increasing the cutting surface area of theslot306 and the amount of sample material that can be collected within theslot306.
• FIG. 13 is a perspective view of a portion of thebiopsy needle100 near the distal end. As shown, theneedle100 further includescollet105 coupled to a portion of theneedle body102. The length of theneedle collet105 may be in the range of 2 mm to 10 mm, but more preferably in the range of 3.5 mm to 5 mm. It is preferable that the outer diameter of theneedle collet105 be in the range of 0.030 inches to 0.080 inches, but more preferably in the range of 0.040 inches to 0.070 inches, depending on the gauge of theneedle100. Theneedle collet component105 may be chamfered at the proximal and distal ends thereof. In some embodiments, it may be preferable that the chamfer angle of theneedle collet105 be in the range of 15 degrees to 80 degrees, relative to a longitudinal axis X of theneedle100, but more preferably in the range of 30 degrees to 60 degrees. The chamfer on both ends of theneedle collet105 may provide smooth locking and unlocking with theneedle protector sub-assembly9 during needle exchanges.
• Theneedle collet105 is located at a set point distance from thedistal end104 of theneedle100. The distance from thedistal end104 of the needle to the proximal collet position on theneedle100 may be within the range of 6 cm to 12 cm, but is more preferably in the range of 7 cm to 9 cm, and more preferably is located 8 cm from the end of theneedle100. This ensures that when the needle is extended to a maximum extension distance relative to thedistal end14aof the sheath (i.e. 8 cm), thecollet105 does not exit the end ofsheath14, as shown inFIGS. 14A and 14B.
• In the illustrated embodiment, aportion128 of theneedle body102 adjacent thedistal end104 and/or thecutting slot106 may incorporate an embodiment to enhance the echogenic signature of theneedle100. For example, this echogenicallyenhanced region128 can be fabricated by, but not limited to, roughening the end of the needle over a pre-defined length adjacent to at least the first and second tip portions of thedistal end104. The length of the echogenicallyenhanced region128 may be in the range of 2 mm to 20 mm, but is more preferably in the range of 10 mm to 15 mm. The echogenicenhanced pattern128 may be imparted to theneedle body102 via a micro-blasting process which roughens the surface of the needle over a specific length, improving the visibility of the needle under endoscopic ultrasound. In other embodiments, the echogenicallyenhanced region128 of theneedle100 may be achieved through the removal of material from the surface of the needle to provide greater reflectivity and strengthened reflected signal. It is contemplated that the removal of material does not, however, reduce the performance of the needle from a pushability perspective or deter its ability to acquire a desired sample.
• FIGS. 14A and 14B are side views, partly in section, of storage and extension of thebiopsy needle100 ofFIG. 13 within thesheath14 of the delivery system ofFIG. 1. Referring toFIG. 14A, theneedle100 is shown loaded within thesheath14 with the device handle in the fully retracted position and ready for extension into a target site for sample collection. In this instance, thedistal end104 of theneedle100 lies proximal to the distaltapered end14aof thesheath14.FIG. 14B illustrates the position of theneedle100 andneedle collet105 relative thesheath14 when the needle transitions to a fully extended position, as indicated byarrow130. In the fully extended position, theneedle collet105 remains housed insidesheath14, proximal to the tapered distal tip, thereby preventing theneedle100 from extending past a set distance from thesheath14.
• It is important that theneedle100 can be passed through an internal diameter of asheath14 of the delivery device (shown inFIG. 1) without catching on an internal wall of same, particularly during tissue collection procedures and/or needle exchange. As the needle advances, the heel of the back-cut grind118 may come in contact with the internal diameter of thesheath14 and reduce the friction between thedistal end104 of theneedle100, particularly the pointedtip116 and thesheath14. In this way, theneedle200 can be smoothly tracked through the sheath to exit the end of the sheath. This feature also makes it easy to remove a needle and re-insert a new needle while the rest of a delivery device remains within a patient during a procedure.
• FIG. 15 illustrates thebiopsy needle100 ofFIG. 5 inserted into asample tissue132 for collection (e.g., biopsy or harvesting) of at least a portion of thesample tissue132.FIGS. 16 and 17 are enlarged side views, partly in section, of thedistal end104 and cuttingslot106 inserted within thesample tissue132, illustrating sample tissue collection procedures using thebiopsy needle100. As shown, theneedle100 may be extended from thesheath14 when delivered to a target site. An operator (e.g., physician or other trained medical personnel) may then advance thedistal end104 of theneedle100 towards thetarget tissue132 to be sampled (with or without the assistance of use of ultrasound techniques). Upon piercing and entering thetissue132, an operator may then begin the collection of tissue. In the illustrated embodiment, thetarget tissue132 may be an abnormal mass, such as a tumor or the like.
• As previously described, theproximal cutting end110 of thecutting slot106 may include acutting edge124. Accordingly, as shown inFIG. 16, upon movement of theneedle body100 in a distal direction along the longitudinal axis X, as indicated byarrow136, thecutting edge124 of theproximal cutting end110 is configured to make contact with thetissue132, as indicated byarrow138, and further excise asample material140 therefrom and into thelumen108, as indicated byarrow142. In one embodiment, a vacuum may be communicated from the proximal end to at least the cuttingslot106 through thelumen108 so as to provide a suction force to thetarget tissue132 and further assist in collection and harvesting of thetissue sample138 via aspiration.
• Thedistal cutting end112 of thecutting slot106 may also, or alternatively, include acutting edge126. Accordingly, as shown inFIG. 17, upon movement of theneedle body100 in a proximal direction along the longitudinal axis X, as indicated byarrow144, thecutting edge126 of thedistal cutting end112 is configured to make contact with thetissue132, as indicated byarrow146, and further excise asample material148 therefrom and into thelumen108. Similarly, a vacuum may be communicated from the proximal end to at least the cuttingslot106 through thelumen108 so as to provide a suction force to thetarget tissue132 and further assist in collection and harvesting of thetissue sample148 via aspiration.
• In some embodiments, at least one of the opposingsidewalls114a,114bmay include a cutting edge extending along a length thereof, such that the cutting edge is configured to contact and excise a sample material upon rotational movement of theneedle body102 about the longitudinal axis X.
• In one embodiment, the collection of tissue may involve multiple passes of the proximal and distal cutting ends110,112 within thetissue sample132. For example, theneedle100 may be moved in a back-and-forth motion for a number of repetitions (e.g., within the range of 1 to 20 repetitions) so as to harvest a representative sample of the tissue.
• FIGS. 18 and 19 are perspective views of another embodiment of abiopsy needle400 consistent with the present disclosure.FIG. 20 is a side profile view of thedistal end404 of thebiopsy needle400 ofFIGS. 18 and 19. Thebiopsy needle400 generally includes an elongatetubular body402 having a longitudinal axis X. Thebody402 further includes an open proximal end (not shown), an opendistal end404, an outer surface, and an inner surface defining alumen406 extending along the longitudinal axis X between the proximal end anddistal end404.
• Theneedle400 further includes a cutting tip defined on thedistal end404 of thebody402. The cutting tip generally includes afirst portion408 and asecond portion410, each extending from aproximal surface411 of the cutting tip and converging at apointed end412 of the cutting tip. As shown, the first andsecond portions408,410 are generally formed on opposing sides of theneedle body402. Thefirst portion408 is from at least afirst bevel grind413 that extends from theproximal surface411 of the cutting tip and terminates at thepointed end412. Thefirst bevel grind413 is oblique to the outer surface of theneedle body402. Thefirst portion408 further includes a curvilinear, or arcuate, cuttingedge414 extending along a length of thefirst bevel grind413 between theproximal surface411 and thepointed end412 of the cutting tip. During a tissue collection procedure, thecutting edge414 is configured to excise tissue upon contact therewith. Thefirst portion408 generally acts a coring element, such that, upon rotational movement of theneedle body402 about the longitudinal axis X, thecutting edge414 is configured to shear a tissue sample and further draw the sheared tissue into thelumen406 of theneedle body402 for harvesting, as described in greater detail herein.
• Thesecond portion410 of the cutting tip generally defines a side slot formed from a second set of bevel grinds. Thesecond portion410 is generally formed by removal of a beveled portion of theneedle body402 opposing thefirst portion408 and substantially identical thereto, as generally illustrated by the dotted line inFIG. 18. The second set of bevel grinds includes asecond bevel grind415 extending from theproximal surface411 and lying along a plane that is oblique to a longitudinal plane along which theneedle body402 lies. More specifically, thesecond bevel grind415 is generally orthogonal to the longitudinal axis X of thebody402. The second set of bevel grinds further includes athird bevel grind416 extending from thesecond bevel grind416 and towards thepointed end412 of the cutting tip. Thethird bevel grind416 is substantially parallel to the longitudinal axis X of thebody402. Afourth bevel grind417 extends from thethird bevel grind416 and terminates at thepointed end412 of the cutting tip. Thefourth bevel417 is oblique to thethird bevel grind416. In the illustrated embodiment, thefirst bevel grind413 and thefourth bevel grind417 may be the same. At least one of the second, third, and fourth bevel grinds415,416,417 may include a cutting edge along a length thereof to assist in sample collection. For example, at least thefourth bevel grind417 may include cuttingedge418 configured to excise a sample material (e.g., tissue) upon contact therewith to assist in sample collection during a biopsy procedure. As shown inFIG. 20, the cutting tip may further include a back-cut bevel grind420 oblique to the outer surface of thebody402 and proximate to and terminating at thepointed end412 of the cutting tip. The back-cut bevel grind420 is similar to the back-cut bevel grind118 ofneedle100 and provides the same advantages previously described herein.
• It should be noted thatbiopsy needle400 is configured to be used with the delivery system ofFIG. 1. Accordingly, thebiopsy needle400 may further include additional elements, including, but not limited to, a collet and/or an echogenically enhanced or acoustic reflection region, as shown in FIGS.13 and14A-14B with respect toneedle100, and further provide the same benefits associated with each when performing a biopsy procedure.
• FIG. 21 illustrates thebiopsy needle400 ofFIGS. 18-20 inserted into asample tissue422 for collection (e.g., biopsy or harvesting) of at least a portion of thesample tissue422.FIG. 22 is an enlarged perspective view of the cutting tip of thebiopsy needle400 inserted into thesample tissue422, illustrating the initiation of sample tissue collection with thebiopsy needle400. As shown, theneedle400 may be extended (from thesheath14 of the delivery system ofFIG. 1) when delivered to a target site. An operator (e.g., physician or other trained medical personnel) may then advance thedistal end404 of theneedle400 towards thetarget tissue422 to be sampled (with or without the assistance of use of ultrasound techniques). Upon piercing and entering thetissue422, an operator may then begin the collection of tissue. In the illustrated embodiment, thetarget tissue420 may be abnormal mass, such as a tumor or the like, for example.
• Upon movement of theneedle body402 in a distal direction along the longitudinal axis X, as indicated by arrow424, thepointed end412 of the cutting tip is configured to make contact with and pierce thetissue422. Upon entering and residing within thetissue422, at leastcutting edge418 formed on thesecond portion410 of the cutting tip may excise a portion of thetissue422 and allow a sample of tissue to be collected within thelumen406. The operator may then rotate theneedle400 about the longitudinal axis X, as indicated byarrow426. In particular, the operator may rotate theneedle hub17 of the delivery system while theneedle400 is extended from thesheath14 and within thetissue422. For example, in one embodiment, theneedle hub17 of the needle sub-assembly15 (shown inFIGS. 2 and 4) may be configured to rotate while releasably coupled to the handle10 of the delivery device by way of thethumb latch28. Upon rotating theneedle hub17, thedistal end404 of theneedle400 may rotate about the longitudinal axis X in a direction resulting in thecutting edge414 of thefirst portion408 to excise and effectively shear a core tissue sample from thetissue422. In one embodiment, a vacuum may be communicated from the proximal end of theneedle body402 to thedistal end404 of theneedle body402 through thelumen406 so as to provide a suction force to thetarget tissue422 and further assist in collection and harvesting of the tissue sample via aspiration during the coring technique.
• The distinct configuration of the cutting tip of theneedle400 provides improved tissue collection. In particular, the use of a coring technique, by way of rotational movement, in conjunction with the conventional lateral movement ensures that the needle is guided into the tissue in a controlled manner, thereby minimizing the opportunity for needle mishits or needle shaft deflection when attempting to collect a sample. Additionally, the coring element of the cutting tip further allows tissue to be guided into the lumen in controlled manner and further maximizes the amount of tissue to be harvested.
• FIG. 23 is a perspective view of a portion of another embodiment of abiopsy needle500 consistent with the present disclosure.FIG. 24 is a side profile view of thedistal end504 of thebiopsy needle500 ofFIG. 23. Thebiopsy needle500 generally includes an elongatetubular body502 having a longitudinal axis X. Thebody502 further includes an open proximal end (not shown), an opendistal end504, an outer surface, and an inner surface defining alumen506 extending along the longitudinal axis X between the proximal end anddistal end504.
• The opendistal end504 is formed from at least first and a second angular bevel grinds508,510, oblique to the outer surface of theneedle body502. Each of the first and second bevel grinds508,510 generally extend from aproximal surface512 of thedistal end504 and terminate at apointed tip513. At least one of the first and second bevel grinds508,510 may define a cutting edge configured for excising a sample material when in contact therewith, particularly during a biopsy procedure. In the illustrated embodiment, each of the first and second bevel grinds508,510 defines acutting edge509,511, respectively.
• Thebiopsy needle500 further includes acutting slot514 extending from the open distal end in a direction away from the pointedtip513 and towards the proximal portion of theneedle body502. The cuttingslot514 extends through the outer and inner surfaces and into thelumen506 of thebody502. The cuttingslot514 includes opposingsidewalls516a,516bextending from theproximal surface512 of the opendistal cutting end504 and terminating at abase wall518. As shown, the opposingsidewalls516a,516bare formed from third and fourth distinct angular bevel grinds extending from theproximal surface512 of the opendistal cutting end504, generally in a diagonal direction relative to a longitudinal plane along which theneedle body402 lies. Thebase wall518 is formed from a fifth bevel grind oblique to the third and fourth bevel grinds. As shown, the fifth bevel grind may be substantially parallel to the longitudinal axis X of theneedle body502. In one embodiment, the cuttingslot514 generally has a helical shape, such that thesidewalls516a,516brevolve about the outer surface of thebody502 relative to the longitudinal axis X. Depending on the type of sample to be collected, as well as the target site from which the sample is to be collected, the cuttingslot514 may extend between 0.1 to 0.9 revolutions about the needle body502 (as measured between theproximal surface512 of thedistal end504 to thebase wall518 of thecutting slot514 about the longitudinal axis X along the circumference of the needle body502). In one embodiment, the helical cutting slot extends approximately 0.35 revolutions along theneedle body502.
• At least one of the opposingsidewalls516a,516bandbase wall518 may define a cutting edge configured for excising a sample material when in contact therewith, particularly during a biopsy procedure. For example, each of the opposingsidewalls516a,516bmay define acorresponding cutting edge520,522 and thebase wall518 may also define acutting edge524. In the illustrated embodiment, each of the opposingsidewalls516a,516bextends from the first and second bevel grinds508,510, respectively, at theproximal surface512. Accordingly, each of the opposingsidewalls516a,516bmay share a corresponding cutting edge with the associate first and second bevel grinds508,510, respectively. For example, cuttingedge509 may extend from the pointedtip513, along thefirst bevel grind508 of thedistal cutting end504, along thesidewall516aand terminating at thebase wall518. Similarly, cuttingedge511 may extend from the pointedtip513, along thesecond bevel grind510 of thedistal cutting end504, along thesidewall516band terminating at thebase wall518.
• As shown inFIG. 24, thedistal cutting end504 of theneedle500 may further include back-cut bevel grind526 oblique to the outer surface of thebody502 and proximate to and terminating at thepointed tip513. The back-cut bevel grind526 is similar to the back-cut bevel grind118 ofneedle100 and provides the same advantages previously described herein.
• It should be noted thatbiopsy needle500 is configured to be used with the delivery system ofFIG. 1. Accordingly, thebiopsy needle500 may further include additional elements, including, but not limited to, a collet and/or an echogenically enhanced or acoustic reflection region, as shown in FIGS.13 and14A-14B with respect toneedle100, and further provide the same benefits associated with each when performing a biopsy procedure.
• FIG. 25 illustrates thebiopsy needle500 ofFIGS. 23 and 24 inserted into asample tissue528 for collection (e.g., biopsy or harvesting) of at least a portion of thesample tissue528.FIG. 26 is an enlarged perspective view of thedistal end504 and cuttingslot514 inserted within thesample tissue528, illustrating the initiation of sample tissue collection with thebiopsy needle500. As shown, theneedle500 may be extended (from thesheath14 of the delivery system ofFIG. 1) when delivered to a target site. An operator (e.g., physician or other trained medical personnel) may then advance thedistal end504 of theneedle500 towards thetarget tissue528 to be sampled (with or without the assistance of use of ultrasound techniques). Upon piercing and entering thetissue528, an operator may then begin the collection of tissue. In the illustrated embodiment, thetarget tissue528 may be abnormal mass, such as a tumor or the like, for example.
• Upon movement of theneedle body502 in a distal direction along the longitudinal axis X, as indicated by arrow530, thepointed tip513 of thedistal cutting end504 is configured to make contact with and pierce thetissue528. Upon entering and residing within thetissue528, the cuttingedges509,511 of the first and second bevel grinds508,510 may excise portions of thetissue528 and allow a sample of tissue to be collected within thelumen506.
• Upon forcing thedistal cutting end504 deeper into the targetedtissue528, thehelical cutting slot514 is configured to further assist is sample tissue collection and drawing a sampled tissue core within thelumen506. For example, in one embodiment, an operator need only move theneedle body502 in a linear motion in proximal and distal directions, such that as thedistal cutting end504 is forced further into thetissue528, the cuttingedges520,522 of thesidewalls516a,516bare configured to catch and excise surrounding tissue, thereby effectively shearing a core tissue sample from thetissue528. Additionally, or alternatively, an operator may rotate theneedle500 about the longitudinal axis X, as indicated byarrow532, once thedistal cutting end504 has pierced thetissue528 and thecutting slot514 is positioned within thetissue528. In particular, the operator may rotate theneedle hub17 of the delivery system while theneedle500 is extended from thesheath14 and penetrating thetissue528. For example, in one embodiment, theneedle hub17 of the needle sub-assembly15 (shown inFIGS. 2 and 4) may be configured to rotate while releasably coupled to the handle10 of the delivery device by way of thethumb latch28. Upon rotating theneedle hub17, thedistal end504, and cuttingslot514, of theneedle500 may rotate about the longitudinal axis X in a direction resulting in the cutting edges520,522, and524 of the opposingsidewalls516a,516b, andbase wall518 contacting and excising surrounding tissue. The helical configuration of thecutting slot514 may draw the tissue in a proximal direction, thereby drawing the sampled tissue into thelumen506 and effectively shearing a core tissue sample from thetissue528. In one embodiment, a vacuum may be communicated from the proximal end of theneedle body502 to thedistal end504 of theneedle body502 through thelumen506 so as to provide a suction force to thetarget tissue528 and further assist in collection and harvesting of the tissue sample via aspiration during the helical shearing technique.
• The distinct configuration of the cutting tip of theneedle500 provides improved tissue collection. In particular, the helical cutting slot further increases the cutting surface of the distal cutting end, thereby maximizing the amount of tissue that can be harvested. Additionally, the helical cutting slot feature further ensures that the needle is guided into the tissue in a controlled manner, thereby minimizing the opportunity for needle mishits or needle shaft deflection when attempting to collect a sample.
• While several embodiments of the present disclosure have been described and illustrated herein, those of ordinary skill in the art will readily envision a variety of other means and/or structures for performing the functions and/or obtaining the results and/or one or more of the advantages described herein, and each of such variations and/or modifications is deemed to be within the scope of the present disclosure. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the teachings of the present disclosure is/are used.
• Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments of the disclosure described herein. It is, therefore, to be understood that the foregoing embodiments are presented by way of example only and that, within the scope of the appended claims and equivalents thereto, the disclosure may be practiced otherwise than as specifically described and claimed. The present disclosure is directed to each individual feature, system, article, material, kit, and/or method described herein. In addition, any combination of two or more such features, systems, articles, materials, kits, and/or methods, if such features, systems, articles, materials, kits, and/or methods are not mutually inconsistent, is included within the scope of the present disclosure.
• All definitions, as defined and used herein, should be understood to control over dictionary definitions, definitions in documents incorporated by reference, and/or ordinary meanings of the defined terms.
• The indefinite articles “a” and “an,” as used herein in the specification and in the claims, unless clearly indicated to the contrary, should be understood to mean “at least one.”
• The phrase “and/or,” as used herein in the specification and in the claims, should be understood to mean “either or both” of the elements so conjoined, i.e., elements that are conjunctively present in some cases and disjunctively present in other cases. Other elements may optionally be present other than the elements specifically identified by the “and/or” clause, whether related or unrelated to those elements specifically identified, unless clearly indicated to the contrary.
• Reference throughout this specification to “one embodiment” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, appearances of the phrases “in one embodiment” or “in an embodiment” in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.
• The terms and expressions which have been employed herein are used as terms of description and not of limitation, and there is no intention, in the use of such terms and expressions, of excluding any equivalents of the features shown and described (or portions thereof), and it is recognized that various modifications are possible within the scope of the claims. Accordingly, the claims are intended to cover all such equivalents.
INCORPORATION BY REFERENCE
• References and citations to other documents, such as patents, patent applications, patent publications, journals, books, papers, web contents, have been made throughout this disclosure. All such documents are hereby incorporated herein by reference in their entirety for all purposes.
EQUIVALENTS
• Various modifications of the invention and many further embodiments thereof, in addition to those shown and described herein, will become apparent to those skilled in the art from the full contents of this document, including references to the scientific and patent literature cited herein. The subject matter herein contains important information, exemplification and guidance that can be adapted to the practice of this invention in its various embodiments and equivalents thereof.

Claims (14)

What is claimed is:

1. A biopsy needle comprising:

an elongate tubular body having a longitudinal axis and comprising a proximal portion having a proximal end, a distal portion having a distal end, an outer surface, and an inner surface defining a lumen extending along the longitudinal axis between the proximal and distal portions; and

a cutting slot defined on one side of the distal portion of the body and extending through the outer and inner surfaces and into the lumen of the body, the cutting slot comprising:

a proximal cutting end and an opposing distal cutting end; and

opposing sidewalls defined between the proximal and distal cutting ends and extending along a length of the body and parallel to the longitudinal axis,

wherein at least one of the proximal and distal cutting ends defines a concave shape having a cutting edge configured to excise a sample material upon contact therewith so as to capture the sample material within the lumen of the body.

2. The biopsy needle ofclaim 1, wherein the cutting edge has an acute angle.

3. The biopsy needle ofclaim 1, wherein the cutting edge is V-shaped.

4. The biopsy needle ofclaim 1, wherein each of the proximal and distal cutting ends of the slot has a concave geometry having a cutting edge.

5. The biopsy needle ofclaim 1, wherein the distal cutting end is configured to make contact with and excise a sample material upon movement of the needle body in a proximal direction along the longitudinal axis and the proximal cutting end is configured to make contact with and excise a sample material upon movement of the needle body in a distal direction along the longitudinal axis.

6. The biopsy needle ofclaim 1, wherein at least one of the opposing sidewalls has a cutting edge extending along a length thereof, the cutting edge configured to contact and excise a sample material upon rotational movement of the needle body about the longitudinal axis.

7. The biopsy needle ofclaim 1, wherein the distal end of the body is formed from a set of distinct angular bevel grinds oblique to the longitudinal axis of the body and defining a pointed tip configured for penetrating material to be sampled.

8. The biopsy needle ofclaim 7, wherein the set of angular bevel grinds comprises a first bevel grind extending from the distal end and towards the pointed tip, a second bevel grind extending from the first bevel grind and terminating at the pointed tip, and a back-cut bevel grind oblique to outer surface of the body and proximate to the pointed tip for providing a smooth needle passage during needle insertion and withdrawal during a biopsy procedure.

9. The biopsy needle ofclaim 1, wherein the proximal end of the body is open ended and the lumen is configured to communicate a vacuum from the proximal end to at least the cutting slot to provide a suction force to the material to be sampled.

10. The biopsy needle ofclaim 9, wherein the distal end of the body is open ended and the lumen is configured to communicate a vacuum from the open proximal end to the open distal end to provide a suction force to the material to be sampled.

11. The biopsy needle ofclaim 1, further comprising a section of the distal portion of the body having enhanced echogenicity or acoustic reflection.

12. The biopsy needle ofclaim 1, further comprising a collet surrounding a section of the distal portion of the body and having a diameter sufficient to prevent the needle body from entirely passing through a distal end of a sheath of a biopsy device.

13. The biopsy needle ofclaim 1, wherein the needle body has an outer diameter in the range of 10-gauge to 30-gauge.

14. The biopsy needle ofclaim 1, wherein the needle is comprised of a material selected from the group consisting of nitinol, cobalt chrome, stainless steel, a metal alloy, one or more polymers, nanotube composite, and combinations thereof.

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