Biopsy device

Abstract

To provide a biopsy device for acquiring a tissue sample.SOLUTION: Various embodiments are generally directed to biopsy devices, systems, and methods for acquiring a tissue sample, such as during fine-needle aspiration cytology. Several embodiments are particularly directed to biopsy devices with features to facilitate accessing, acquiring, and / or retaining one or more tissue samples from a target biopsy site. In one embodiment, for example, a biopsy device may include an elongate member having an insert disposed within a lumen of an elongate member. The insert may be configured to mate with a needle disposed in the lumen to maintain a rotational orientation of the needle. In another embodiment, a needle may include multiple openings for acquiring a tissue sample. In yet another embodiment, a helical component may be disposed in a needle lumen to acquire and retain tissue samples.SELECTED DRAWING: Figure 2B

Description

Technical Field

[0001] The present disclosure generally relates to medical devices, systems, and methods. In particular, the present disclosure relates to biopsy devices, systems, and methods.

Background Art

[0002] Biopsy is a group of medical diagnostic tests used to determine the structure and composition of tissues or cells. In a biopsy procedure, cells or tissues are sampled from an organ or other body part to enable their analysis, for example, under a microscope. If an abnormality is detected by a surface examination such as palpation or radiography, a biopsy can be performed to determine the nature of the suspected abnormality. Generally, biopsies can be classified into either excisional biopsies or incisional biopsies. An excisional biopsy may involve the removal of an entire nodule or suspected area. On the other hand, an incisional biopsy may involve sampling a portion of abnormal tissue without attempting to remove the entire lesion or tumor. Incisional biopsies are generally safer and less traumatic than excisional biopsies. In one type of incisional biopsy, fine needle aspiration (FNA), a sample of tissue or body fluid is removed with a needle such that cells are removed without preserving the histological structure of the tissue cells. Generally, the needle in FNA is inserted through the working channel of an endoscope to access the target site and obtain a tissue sample.

[0003] With these considerations in mind, various advantageous medical outcomes can be achieved by the devices, systems, and methods of the present disclosure.

Summary of the Invention

[0004] In one aspect, the present disclosure relates to a biopsy device comprising a elongate member and an insert. The elongate member may have a proximal portion, a distal portion, and a lumen. The lumen may include a proximal opening and a distal opening and may extend from the proximal portion to the distal portion of the elongate member. The insert may be disposed within the lumen. The insert may include a lumen contact portion and a needle contact portion. The insert may be configured to engage an insert contact portion of a needle disposed within the lumen and maintain a rotational orientation of the needle.

[0005] In some embodiments, the insert restricts proximal or distal movement of the needle disposed within the lumen. In various embodiments, the insert contact portion comprises a flat surface generated by removing material from the curved surface of the needle. In many embodiments, the device comprises the needle, and the insert contact portion of the needle is configured to slide along the needle contact portion of the insert when the needle and the insert are engaged. Many such embodiments include a polymeric stylet disposed within the needle. In some such embodiments, the needle is configured to slide longitudinally when the insert contact portion engages the needle contact portion. In various such embodiments, the needle contact portion of the insert extends along the longitudinal axis of the elongate member by a first length, and the insert contact portion of the needle extends along the longitudinal axis of the elongate member by a second length, and the first length is shorter than the second length. In some embodiments, the lumen contact portion comprises a curved surface and the needle contact portion comprises a flat surface. In a plurality of embodiments, the needle contact portion comprises one or more of a channel, a groove, and a zigzag. In some embodiments, the needle contact portion comprises a channel extending along the longitudinal axis of the elongate member. In various embodiments, the elongate member comprises a second lumen, and the distal opening of the lumen is orthogonal to the distal opening of the second lumen. In many embodiments, the device comprises the needle, and the needle includes a needle lumen having a first opening and a second opening, and the first opening and the second opening are in the distal half of the needle. In many such embodiments, the first opening of the needle lumen is orthogonal to the second opening of the needle lumen. In some such embodiments, a sheath is disposed around a portion of the needle, and the sheath covers the first opening of the needle lumen. In various such embodiments, the needle comprises a scoop disposed adjacent to the first opening.

[0006] In another aspect, the present disclosure relates to a system comprising a elongate member, an insert, and a needle. The elongate member may have a proximal portion, a distal portion, and a lumen. The lumen may include a proximal opening and a distal opening and may extend from the proximal portion to the distal portion of the elongate member. The insert may be disposed within the lumen. The insert may include a lumen contact portion and a needle contact portion. The needle may be disposed within the lumen and may include an insert contact portion. The needle contact portion and the insert contact portion may include corresponding engagement features.

[0007] Some embodiments include a stylet disposed within the lumen of the needle. In some such embodiments, the stylet includes a polymer. In various embodiments, the needle may include a needle lumen having a first opening and a second opening in the distal half of the needle. In various such embodiments, the first opening of the needle lumen is orthogonal to the second opening of the needle lumen.

[0008] In yet another aspect, the present disclosure relates to a method. The method may include one or more of forming an insert having a needle contact portion, forming a needle having an insert contact portion corresponding to the needle contact portion of the insert, engaging the needle contact portion with the insert contact portion, and disposing the insert and the needle within a lumen of an elongate member.

[0009] In some embodiments, the method may include one or more of forming a stylet from a polymer and disposing the stylet within the lumen of the needle. In various embodiments, the method includes press-fitting the insert into the lumen. In many embodiments, the method includes grinding the needle to form the insert contact portion. In some embodiments, the method includes pressing the needle to form the insert contact portion. In multiple embodiments, the method includes forming the insert by stamping. In some embodiments, the method includes disposing the insert and the needle within the lumen using press-fitting. In various embodiments, the method includes disposing the insert and the needle within the lumen using thermal fitting.

Brief Description of the Drawings

[0010] Non-limiting embodiments of the present disclosure are described by way of example with reference to the accompanying drawings, which are schematic and not intended to be shown to scale. In the figures, each identical or nearly identical component shown is generally denoted by a single number. For clarity, not all components are labeled in all drawings, and not all components of each embodiment are shown, when the drawings are not necessary for one skilled in the art to understand the present disclosure.

[0011]

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[0012] Various embodiments generally relate to biopsy devices, systems, and methods for obtaining tissue samples, such as during a fine needle aspiration biopsy. Some embodiments particularly relate to biopsy devices having features for facilitating access to, acquisition of, and / or retention of one or more tissue samples from a target biopsy site. In one embodiment, for example, a biopsy device may include a elongate member having an insert disposed within a lumen of the elongate member. The insert may be configured to engage a needle disposed within the lumen to maintain a rotational orientation of the needle. In another embodiment, the needle may include a plurality of openings for obtaining a tissue sample. In yet another embodiment, a helical component may be disposed within the needle lumen for obtaining and retaining a tissue sample. These and other embodiments are described and claimed.

[0013] Some of the challenges in obtaining tissue samples include ensuring the acquisition of viable samples (e.g., the sample may be too small and / or not from the biopsy target site), preventing needle breakage or kinking, and controlling the needle orientation and / or angle of incidence. For example, the target site may be small and difficult to reach (e.g., located in the distal region of the lung). Often, after each sample is obtained or an attempt is made to obtain it, the needle needs to be removed from the patient and reinserted. Additionally, adjusting the angle of incidence of the needle may require repositioning the endoscope in which the needle is placed. Both can lead to long recovery times and overly invasive procedures. Even more complex, needles are fragile and may be prone to damage such as kinking. Many such needles are required to remain mostly within a protective sheath or catheter. These and other factors can limit the capabilities, reduce the applicability, make the adaptability poor, and limit the functionality of biopsy devices and methods. Such limitations can significantly reduce the quality and usefulness of biopsy devices and contribute to an inadequate user experience and harmful outcomes for patients.

[0014] Accordingly, various embodiments of the present disclosure include a biopsy device having features that facilitate accurate and reliable access to, acquisition of, and / or retention of one or more tissue samples from a target biopsy site. In many embodiments, one or more of the features can control an orientation needle disposed within a lumen. In various embodiments, one or more of the features can enable adjustment of the needle's angle of incidence and / or acquisition of multiple samples without removal from the body lumen, resulting in a more efficient and / or reliable biopsy procedure. For example, being able to acquire tissue samples over a range or region without repositioning a elongate member and / or a bronchoscope in which the elongate member is disposed can directly reduce trauma to the patient and potentially improve outcomes. In some embodiments, one or more of the features can provide additional strength and / or durability to the needle, such as via a stylet or solid bore. In some embodiments, one or more of the features can improve the quantity and / or quality of tissue samples, such as via bidirectional tissue acquisition. In these and other ways, the components / techniques described herein can improve a biopsy device.

[0015] It can be understood that the disclosure contained herein is merely illustrative and explanatory and not restrictive. As used herein, the terms "comprising," "including," or any other variation thereof are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus comprising a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. The term "exemplary" is used in the sense of "example" rather than "ideal." Although endoscopes and endoscopic systems are referenced herein, references to endoscopes, endoscopic systems, or endoscopic examinations should not be construed as limiting the possible uses of the disclosed aspects. For example, the disclosed aspects can be used in conjunction with duodenoscopes, bronchoscopes, ureteroscopes, colonoscopes, catheters, diagnostic or therapeutic tools or devices, or other types of medical devices or systems.

[0016] Next, referring to the drawings, like reference numerals are used throughout to refer to like elements. In the following description, for purposes of explanation, numerous specific details are set forth in order to provide a thorough understanding of the present invention. It will be apparent, however, that new embodiments may be practiced without these specific details. In other instances, well-known structures and devices are shown in block diagram form in order to facilitate the description. The intention is to cover all modifications, equivalents, and alternatives within the scope of the claims.

[0017] Figures 1A through 1E illustrate various aspects of the distal portion 110 of the biopsy device 100 in accordance with one or more embodiments of the present disclosure. More specifically, FIG. 1A includes a cross-sectional view of the biopsy device 100 including a probe 103 with a needle 104-n disposed therein. FIG. 1B includes a cross-sectional view of the probe 103 of the biopsy device 100. FIG. 1C shows a perspective view of the biopsy device 100 including the needle 104-1, the elongate member 102, and the probe 103. FIG. 1D shows a perspective view of the biopsy device 100 including the needle 104-2, the elongate member 102, and the probe 103. FIG. 1E shows a perspective view of the biopsy device 100 including the needle 104-3, the elongate member 102, and the probe 103. In various embodiments, the needles 104-1, 104-2, 104-3 may provide three different angles of incidence for tissue sample acquisition. The needles 104-1, 104-2, 104-3, 104-n (or needle 104) may be selectively disposed within the first lumen 114-1 of the elongate member 102. An imaging device such as an ultrasonic catheter 106 may be disposed within the second lumen 114-2 of the elongate member 102. In some embodiments, the distal portion 110 of the biopsy device 100 may be inserted through the working channel of a bronchoscope and access a target site for tissue acquisition. Figures 1A through 1E may include one or more components that are the same as or similar to one or more other components of the present disclosure. Further, one or more components, or aspects thereof, of Figures 1A through 1E may be incorporated into other embodiments of the present disclosure without departing from the scope of the present disclosure. The embodiments are not limited to this situation.

[0018] One or more biopsy devices disclosed herein may include one or more needles having a predetermined shape that provides one or more angles of incidence for obtaining tissue samples when in a deployed configuration. More generally, biopsy device 100 may include a elongate member 102 having a proximal portion 108 and a distal portion 110. In many embodiments, elongate member 102 may include a dual lumen catheter. In many such embodiments, a needle for FNA may be disposed within the first lumen and an imaging transducer. The distal portion 110 of elongate member 102 may include a probe 103. Probe 103 may include distal openings 116-1, 116-2. The embodiment shown in FIG. 1A includes a needle 106-n extending proximate to distal opening 116-1 and an ultrasonic catheter 106 extending proximate to distal opening 116-2.

[0019] FIGS. 1C through 1E each include needles 104-1, 104-2, 104-3, respectively, in a deployed configuration (i.e., extending outwardly from distal opening 116-2). Each of the needles 104 has a different deployed configuration and provides a different angle of incidence. For example, needle 104-1 may have a neutral angle of incidence, needle 104-2 may have a positive angle of incidence, and needle 104-3 may have a negative angle of incidence. This can be achieved via needles having an arc that varies from negative to positive. The plurality of angles of incidence enables different portions of a nodule to be biopsied. More generally, the plurality of angles of incidence enables tissue samples to be obtained from an entire area or strip. Further, the ability to obtain tissue samples over a range or area without repositioning the elongate member and / or the bronchoscope in which the elongate member is disposed can directly reduce trauma to the patient and may improve outcomes.

[0020] When the ends of needles 104-1, 104-2, and 104-3 are within lumen 114-2, the needles can be in a common storage configuration (i.e., aligned with the longitudinal axis 112 of elongate member 102), as shown for needle 104-n in FIG. 1A. In various embodiments, the shape memory material can facilitate the transition between the storage configuration and the deployment configuration. As will be discussed in more detail below with respect to FIGS. 2A-4, the orientation of the needles can be controlled via an insert disposed within the lumen. The orientation control can facilitate bending the needles in a predetermined direction with respect to opening 116-1.

[0021] In the illustrated embodiment, probe 103 includes a ramp 118. The ramp 118 can adjust the angle of incidence of needle 104. For example, the ramp 118 can facilitate a radial offset of the contact site between the needle and the target site, such as in the case of an eccentric nodule. In some embodiments, needle 104 can include one or more composite bends or bent portions. For example, there can be a first bend in a first direction and a second bend in a second direction. In some embodiments, one or more of ramp 118 and needle 104 facilitate customization of the angle of incidence, among other characteristics (e.g., contact site offset in one or more dimensions).

[0022] In some embodiments, probe 103 can include an end cap coupled to the distal end of elongate member 102. In other embodiments, probe 103 can include a portion of elongate member 102. For example, the probe can include distal portion 110 of elongate member 102. Additionally, the probe can be integrally formed with the elongate member or formed separately from the elongate member. More generally, the probe can refer to the distal end of a biopsy device inserted into a body lumen.

[0023] One or more of the components disclosed herein can be composed of an elastomer and / or a polymer (e.g., polycarbonate, acrylonitrile butadiene styrene (ABS), high density polyethylene (HDPE), nylon, polyether ether ketone (PEEK), silicone, a thermoplastic, or a plastic, etc.). The various components disclosed herein can be composed of a metal (e.g., stainless steel, titanium, aluminum, or an alloy, etc.). Some of the components disclosed herein can include one or more shape memory materials (e.g., nickel titanium alloy (nitinol)). For example, the bent or bent portion of the needle can include nitinol. In many embodiments, the reduced bending strength of various shape memory materials can be utilized, for example, to prevent deformation by the inclined surface 118.

[0024] Specifically referring to FIG. 1A, the needle 104-n can include a stylet 124. The stylet can provide additional part integrity to resist damage such as deformation. In many embodiments, the stylet 124 can include a composite material such as an engineering plastic and / or a polymer material. In various embodiments, the stylet 124 can function as an extraction member and can discharge a tissue sample from the needle lumen. In some embodiments, the needle may be provided with or may refer to a hypodermic tube. In one or more embodiments, a needle sheath having tight tolerances for the needle can ensure sufficient column strength for the needle to puncture a target site such as a pulmonary nodule.

[0025] Referring to FIG. 1B, probe 103 includes an imaging window 120 and a marker 122. In many embodiments, the imaging window 120 may refer to one or more portions of the probe 103 that substantially transmit the imaging energy wavelength (e.g., from the ultrasonic catheter 106), while the marker 122 may refer to one or more portions of the probe that do not transmit the imaging energy wavelength relatively well. The marker 244 may comprise any medium that absorbs the imaging energy wavelength (e.g., ultrasound). For example, a metal or metal alloy (e.g., stainless steel or nitinol) may be used. In some embodiments, a non-metal such as an air pocket embedded in the wall of the imaging window may be used.

[0026] In various embodiments, the marker 122 may additionally or alternatively be radiopaque so as to appear in X-ray imaging and / or fluoroscopic imaging. In some embodiments, the marker 122 may be positioned to indicate in the generated image where the needle is positioned in the deployed configuration. In some embodiments, the probe 103 may be positioned based on the generated image, and the elongate member 102 may be rotated about its axis to rotate the probe 103 and reposition the distal opening 116-2. For example, the handle assembly coupled to the proximal end of the elongate member 102 may be rotated to align the distal opening 116-2 with the target nodule based on the display of the marker 122 in the generated image. In some such examples, when aligned, one or more needles may be used to contact and / or penetrate the target nodule. In various embodiments, the marker may be embedded in the wall of a lumen such as the wall of the second lumen 114-2. As will be appreciated, device rotation (e.g., the radial orientation of the marker and the needle) may be more important, for example, for the control or orientation and positioning of the needle, and may enable more efficient biopsy of eccentric nodules when biopsying target tissue that has an irregular edge, an asymmetric shape, and does not extend around the entire circumference of the body lumen.

[0027] As an example, marker 122 can be oriented around the imaging window at a known angle from distal opening 116-1. In such a case, for example, when targeting a lung nodule for a core biopsy, marker 122 may be oriented on a radial ultrasound image at a known angle (e.g., an offset angle) from the intended biopsy site, such that a needle exiting distal opening 116-1 aligns precisely with the biopsy site (needle orientation control may further assist with this). In further such examples, marker 122 can be oriented 180 degrees opposite from the intended biopsy site on the radial ultrasound image. In many embodiments, the known angle from the intended biopsy site can be configured such that a tolerance can be provided. For example, marker 122 can be oriented on the radial ultrasound image at 180±35 degrees from the intended biopsy site. By utilizing the offset angle, marker 122 can be prevented from obscuring direct imaging of the target site while still providing an indication of where the needle contacts / punctures the target site.

[0028] Figures 2A through 2C illustrate various aspects of the elongate member 202 in accordance with one or more embodiments of the present disclosure. More specifically, FIG. 2A shows a cross-sectional view of the elongate member 202 having lumens 214-1, 214-2. FIG. 2B shows the insert 228-1, 228-2 (or insert 228) and the needle 204-1 having a needle lumen 226-1 disposed within the lumen 214-2. FIG. 2C shows the insert 228 with a needle 204-2 having a needle lumen 226-2 disposed within the lumen 214. In various embodiments, the insert 228 is associated with the features of the needle 204, and the orientation of the needle can be maintained as it is moved proximally and distally within the elongate member 202. In some embodiments, the insert 228 is associated with the features of the needle 204 and can limit the range of movement of the needle in one or more of the proximal and distal directions. For example, the distance that the needle can extend proximally out of the lumen 214-2 can be limited. In some embodiments, FIGS. 2A through 2C can include one or more components that are the same as or similar to one or more other components of the present disclosure. Further, one or more components of FIGS. 2A through 2C, or aspects thereof, can be incorporated into other embodiments of the present disclosure without departing from the scope of the present disclosure. For example, the needle 204-1 and / or the needle 204-2 can be the same as or similar to one or more of the needles 104. The embodiments are not limited to this circumstance.

[0029] In various embodiments, the needle may include one or more surfaces that contact one or more inserts to maintain the orientation of the needle. Referring to FIG. 2B, needle 204-1 includes a first surface that contacts insert 228-1 and a second surface that contacts insert 228-2. Similarly, referring to FIG. 2C, needle 204-2 includes a first and second surface that contact insert 228-1 and a second surface that contacts insert 228-2. As described in more detail below with respect to FIGS. 3A-3D, the contact surfaces may take on various shape elements to control the orientation of the needle within the lumen. The surface of the needle that contacts the insert may be prepared by various methods such as grinding, pressing, cold working, stamping, machining, multi-dimensional printing, molding, and casting. The method by which the contact surface of the needle is formed may affect the needle lumen. For example, needle lumen 226-2 of needle 204-2 may be elliptical due to the use of a mechanical press to form the contact surface. However, needle lumen 226-1 of needle 204-1 may remain circular due to the use of grinding to form the contact surface. As shown in the illustrated embodiments, lumens 214-1, 214-2 may have different diameters. In various embodiments, one or more diameters of the lumen may be selected to prevent twisting or maintain column strength.

[0030] Figures 3A through 3D show exemplary inserts 328A-1, 328A-2, 328B, 328C, 328D and needles 304B, 304C for a biopsy device according to one or more embodiments of the present disclosure. More specifically, FIG. 3A shows a cross-sectional view of inserts 328A-1, 328A-2. Insert 328A-1 may include a lumen contact portion 332A-1 and a needle contact portion 334A-1, and insert 328A-2 may include a lumen contact portion 332A-2 and a needle contact portion 334A-2. FIG. 3B shows a cross-sectional view of insert 328B together with needle 304B. Insert 328B may include a lumen contact portion 332B and a needle contact portion 334B, and needle 304B may include an insert contact portion 330B and a needle lumen 326B. FIG. 3C shows a cross-sectional view of insert 328C together with needle 304C. Insert 328C may include a lumen contact portion 332C and a needle contact portion 334C, and needle 304B may include an insert contact portion 330B and a needle lumen 326B. FIG. 3D shows a cross-sectional view of insert 328D. Insert 328D may include a lumen contact portion 332D and a needle contact portion 334D. In some embodiments, FIGS. 3A through 3D may include one or more components that are the same as or similar to one or more other components of the present disclosure. Further, one or more components, or aspects thereof, of FIGS. 3A through 3D may be incorporated into other embodiments of the present disclosure without departing from the scope of the present disclosure. For example, needle 304C may be incorporated into biopsy device 100 together with insert 328C without departing from the scope of the present disclosure. The embodiments are not limited to this circumstance.

[0031] In various embodiments, insert 328 may function to maintain an association with corresponding needle features (e.g., insert 328B and needle 304B) and orientation (e.g., rotational orientation of the needle when moved proximally and distally within the lumen of the elongate member). For example, the needle contact portion of each insert may engage the insert contact portion of the corresponding needle. In some embodiments, the needle may be restricted to a range of orientations by the insert. For example, the needle may be rotatable 5 degrees within the lumen. Additionally, each insert may include a lumen contact portion for contacting the wall of the lumen when disposed within the lumen.

[0032] More generally, the contact surface can take on any shape, contour, or pattern. For example, the contact surface can include one or more curved, angled, and / or straight surfaces. In many embodiments, the contact surface can maintain a substantially uniform cross-sectional shape. In many such embodiments, the substantially uniform cross-sectional shape allows the corresponding contact surfaces to move proximally or distally relative to each other. In some embodiments, the change in the cross-sectional shape can be utilized to implement a restriction on the proximal or distal movement of the needle. In some embodiments, the corresponding contact surfaces can be related.

[0033] FIG. 4 shows various aspects of the elongate member 402 for a biopsy device according to one or more embodiments of the present disclosure. More specifically, FIG. 4 includes a side cross-sectional view of the elongate member 402 having lumens 414-1, 414-2. The illustrated embodiment shows restricting the proximal and / or distal movement of the needle 404 having the insert 428 due to, for example, a change in the cross-sectional shape of the insert contact portion 430 and / or the needle contact portion 434. In some embodiments, FIG. 4 can include one or more components that are the same as or similar to one or more other components of the present disclosure. Further, one or more components of FIG. 4, or aspects thereof, can be incorporated into other embodiments of the present disclosure without departing from the scope of the present disclosure. For example, the insert 428 and the needle 404 can be the same as or similar to the insert 228-1 and the needle 204-1. The embodiments are not limited to this situation.

[0034] Figures 5A and 5B show various aspects of a biopsy device needle 504 according to one or more embodiments of the present disclosure. More specifically, FIG. 5A includes a needle 504 having a solid bore 535 and a needle lumen 526 with openings 536-1, 536-2 distal to the solid bore 535. In the illustrated embodiment, the openings 536-1, 536-2 can be orthogonal to each other. FIG. 5B includes a needle 504 having a sheath 538 disposed around a portion of the needle. In some embodiments, FIGS. 5A and 5B can include one or more components that are the same as or similar to one or more other components of the present disclosure. Further, one or more components of FIGS. 5A and 5B, or aspects thereof, can be incorporated into other embodiments of the present disclosure without departing from the scope of the present disclosure. For example, the needle 504 can be incorporated into the biopsy device 100 without departing from the scope of the present disclosure. Embodiments are not limited to this situation.

[0035] The solid bore (or core) of the needle 504 can result in a robust needle with increased column strength and increased bending strength compared to a hollow bore needle. This allows the needle 504 to be inserted into and removed from a lumen (e.g., of an ultrasonic catheter or a double lumen catheter) without damaging the needle. In various embodiments, when a sample is being obtained, the opening 536-2 allows air to exit the needle and prevents a pressure increase within the needle lumen 526 that would impede or limit the ability to obtain and hold a tissue sample therein. Further, the opening 536-2 can facilitate removal of the sample from the needle lumen 526. For example, a stylet can be inserted through the opening 536-2 to expel the sample. In another example, a positive pressure can be generated in the proximal portion of the needle lumen 526 through the opening 536-2 to expel the sample.

[0036] The sheath 538 of FIG. 5B may comprise a vapor seal sheath that surrounds a portion of the needle 504. In various embodiments, the sheath 538 may provide a vacuum within the needle lumen 526 when the needle 504 is withdrawn from the sample site. The generated vacuum can hold a larger sample within the needle lumen 526, thereby providing an improved repeatable sampling process for eccentric nodules. In some embodiments, the sheath 538 may include a valve such as a one-way valve. For example, the sheath 538 may include a one-way valve that allows fluid to exit from the opening 536-2 and avoid a pressure increase within the needle lumen 526 that would prevent or limit the ability to obtain and hold a tissue sample therein.

[0037] FIG. 6 shows a distal portion of a needle 604 for a biopsy device according to one or more embodiments of the present disclosure. More specifically, FIG. 6 includes a side view of the needle 604 having openings 636-1, 636-2, a scoop 640, and a tray 643. In many embodiments, the scoop 640 enables multi-directional sample acquisition. For example, the opening 636-1 at the distal end of the needle 604 may acquire a first tissue sample when the needle moves proximally into the target site, and the scoop 640 may cut a second tissue sample into the tray 642 through the opening 636-2 when the needle moves distally out of the target site. In some embodiments, multi-directional sample acquisition may include linear and / or rotational movement for sample acquisition. In some embodiments, FIG. 6 may include one or more components that are the same as or similar to one or more other components of the present disclosure. Further, one or more components of FIG. 6, or aspects thereof, may be incorporated into other embodiments of the present disclosure without departing from the scope of the present disclosure. For example, the insert 428 and the needle 404 may be the same as or similar to the insert 228-1 and the needle 204-1. The embodiments are not limited to this situation.

[0038] In some embodiments, the scoop 640 can transition between a folded configuration and a deployed configuration. In some embodiments, FIG. 6 can show the scoop in the deployed configuration. On the other hand, in the folded configuration, one or more portions of the scoop 640 can move within the tray 642. For example, in the folded configuration, the scoop 640 can fit within the outer diameter of the cylindrical portion of the needle 604.

[0039] In many embodiments, the scoop 640 can be biased in the expanded configuration. In many such embodiments, the scoop 640 can transition to the folded configuration due to pressure on the proximal surface of the scoop 640. For example, the scoop 640 can transition to the folded configuration when penetrating the target tissue in the distal direction. In such an example, the scoop 640 can return to the deployed configuration before or in response to being removed proximally from the target tissue. Thus, in some embodiments, the scoop 640 can be made of a shape memory material.

[0040] FIG. 7 shows the distal portion of a needle 704 for a biopsy device according to one or more embodiments of the present disclosure. More specifically, FIG. 7 includes a side cross-sectional view of a needle 704 having a needle lumen 726 with a helical element 744 disposed therein. In some embodiments, the helical component 744 can cut out a sample tissue and draw it into the needle lumen 726. For example, the helical component 744 can function similarly to a water screw. In many embodiments, the helical component can be rotated by a power source. In one or more embodiments, the power source can also be utilized to rotate an imaging transducer, such as during radial ultrasound imaging using the ultrasonic catheter 106. In some embodiments, FIG. 7 can include one or more components that are the same as or similar to one or more other components of the present disclosure. Further, one or more components of FIG. 7, or aspects thereof, can be incorporated into other embodiments of the present disclosure without departing from the scope of the present disclosure. For example, the solid bore of the needle 504 can be incorporated into the needle 704 without departing from the scope of the present disclosure. The embodiments are not limited to this situation.

[0041] Figures 8A through 8D illustrate various aspects of a biopsy device needle 804 in accordance with one or more embodiments of the present disclosure. More specifically, FIG. 8A shows a distal portion of needle 804 having components 850-1, 850-2 engaged together in a through configuration with a needle lumen 852. FIG. 8B shows a base 854 of the needle lumen 852, where components 850-1, 850-2 engage together in a sample removal configuration. Thus, one or more of components 850-1, 850-2 can move linearly relative to each other (similar to an insert and a needle). FIG. 8C shows a cross-sectional view of the needle lumen 852 proximate to the lumen base 584. In some embodiments, needle 804 can move to a solid bore proximal to the lumen base 854. FIG. 8D shows a cross-sectional view of needle 804 having a component 850-1 including an interlock mechanism 851-1 and a component 850-2 including an interlock mechanism 851-2. In many embodiments, the interlock mechanism 851-2 can include a solid bore. The interlock mechanisms 851-1, 851-2 enable components 850 to move linearly relative to each other while preventing separation of the components without the proximal end of one component moving beyond the distal end of the other component. In some embodiments, FIGS. 8A through 8D can include one or more components that are the same as or similar to one or more other components of the present disclosure. Further, one or more components of FIGS. 8A through 8D, or aspects thereof, can be incorporated into other embodiments of the present disclosure without departing from the scope of the present disclosure. For example, aspects of the insert contact portion 430 of needle 404 that engage the needle contact portion 434 of needle 404 can be incorporated into needle 804 to limit proximal and / or distal movement of components 850-1, 850-2 relative to each other. In another example, the cross-sectional shape of the interlock mechanisms 851-1, 851-2 can be incorporated into a corresponding insert needle pair without departing from the scope of the present disclosure. The embodiments are not limited to this circumstance.

[0042] The medical devices of the present disclosure are not limited to bronchoscopes and can include various medical devices for accessing body passages, such as catheters, ureteroscopes, duodenoscopes, colonoscopes, arthroscopes, cystoscopes, and hysteroscopes, etc. Further, in some embodiments, references to endoscopy, endoscopic, endoscopes, etc. can generally refer to any medical device inserted into a body lumen. In one or more embodiments, the body passage can be accessed for a biopsy procedure. For example, a bronchoscope can be inserted into a patient for a pulmonary nodule biopsy procedure (the position of the pulmonary nodule can be determined in advance based on virtual mapping and / or radiology, etc.). Once the bronchoscope is positioned, a medical biopsy device can be inserted through the working channel and can also extend out beyond the distal end of the bronchoscope (e.g., 15 centimeters).

[0043] In some embodiments, next, an imaging transducer can be operated within the airway to provide real-time imaging of the pulmonary nodule. Based on the real-time imaging and marker display of the pulmonary nodule, a medical imaging device can be positioned to biopsy the pulmonary nodule. Once positioned, the biopsy needle can be actuated one or more times to obtain one or more core samples within the hollow biopsy needle. Further, aspiration and suction through the needle can be used to remove the sample(s) from the hollow biopsy needle. Further, one or more steps of this process can be repeated as needed at the same or other locations of the nodule and / or at other locations in the same or other airways of the lung.

[0044] All devices and / or methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure. Although the devices and methods of the present disclosure are described from the perspective of preferred embodiments, it will be apparent to those skilled in the art that changes can be applied to the devices and / or methods and to the steps or the order of steps of the methods described herein without departing from the concept, spirit, and scope of the present disclosure. It will be apparent to those skilled in the art that all such similar substitutions and changes are contemplated within the spirit, scope, and concept of the present disclosure as defined by the appended claims.

Claims

1. A needle for insertion into a lumen of a biopsy device, comprising: A solid bore; a needle lumen having a first opening and a second opening distal to the solid bore; and an insert contact portion configured to engage an insert disposed within a lumen of the biopsy device and maintain a rotational orientation of the needle relative to the biopsy device.

2. A needle as described in claim 1, comprising a sheath disposed around a portion of the needle.

3. A needle as described in claim 2, comprising a steam seal surrounding a portion of the needle, the steam seal providing a vacuum within the needle lumen when the needle is withdrawn from the sample site.

4. A needle as described in claim 2, wherein the sheath has a one-way valve configured to allow fluid to escape through the second opening to avoid pressure build-up within the needle lumen.

5. The needle of claim 1, wherein the first opening and the second opening are perpendicular to each other.

6. The needle of claim 1, wherein the second opening is configured to receive a stylet that expels a sample from the needle lumen.

7. The needle of claim 1, further comprising a scoop to enable multi-directional sample acquisition.

8. The needle of claim 1, further comprising a scoop and a tray positioned proximal to the scoop, the scoop configured to excise a tissue sample into the tray as the needle moves distally out of a target site.

9. The needle of claim 7 or 8, wherein the scoop is configured to transition between a folded configuration and an deployed configuration.

10. The needle of claim 9, wherein the scoop is biased toward the deployed configuration.

11. The needle of claim 1, further comprising a helical component disposed within the lumen of the needle, the helical component configured to cut away and draw a sample tissue into the lumen of the needle.

12. The needle of claim 11, wherein the helical component is configured to be rotated by a power source.

13. A needle for insertion into a lumen of a biopsy device, comprising: A solid bore; a first opening distal to the solid bore; a scoop proximal to the first opening; a second opening distal to the scoop; and Insert contact area and wherein the insert contact portion is configured to engage an insert disposed in a lumen of the biopsy device to maintain a rotational orientation of the needle relative to the biopsy device.

14. The needle of claim 13, wherein the scoop is configured to enable multi-directional sample acquisition.

15. The needle of claim 13, wherein the scoop is configured to excise a tissue sample into the second opening as the needle moves distally out of a target site.

16. The needle of claim 14 or 15, wherein the scoop is configured to transition between a folded configuration and an deployed configuration.

17. The needle of claim 13, wherein the second opening includes a tray.

18. The needle of claim 13, further comprising a helical component disposed within the lumen of the needle, the helical component configured to cut away and draw the sample tissue into the lumen of the needle.

19. The needle of claim 18, wherein the helical component is configured to be rotated by a power source.

20. The needle of claim 13, wherein the second opening is configured to receive a stylet that expels a sample from the needle lumen.

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