Biopsy instruments and methods of use

Abstract

One embodiment generally comprises a handle, a first shaft having a first distal portion and a first proximal end coupled to a translation and rotation mechanism, the first shaft defining a lumen. A second shaft may have a second distal portion and a second proximal end coupled to the handle, the first shaft being translatably positioned over the second shaft. A coring edge may be defined upon the first distal portion, the coring edge being configured to cut through a tissue region when rotated about a longitudinal axis of the first shaft. A piercing tip may be positioned upon the second distal portion, the first shaft being translatable via the translation mechanism relative to the second shaft such that the piercing tip is positionable from a piercing position to a retracted position for receiving a tissue sample.

Description

Attorney Docket No.: INVNZ00300WQBIOPSY INSTRUMENTS AND METHODS OF USECROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 682,020 filed August 12, 2024, which is incorporated herein by reference in its entirety.FIELD OF THE INVENTION

[0002] The present invention relates to biopsy instruments. More particularly, the present invention relates to apparatus and methods of use for biopsy instruments which are effective in capturing relatively large tissue samples with reduced risks to patients.BACKGROUND OF THE INVENTION

[0003] Biopsies are regularly performed when tissue samples are desired for performing any number of tests or procedures. In one particular application, a biopsy may be performed within the lungs to obtain lung tissue for suspected lung cancer to confirm diagnosis, determine staging, and / or to enable precision medicine using, for example, molecular profiling called Next-Generation Sequencing (NGS). A sufficient quantity and quality of the biopsied tissue is typically desired for performing each diagnostic test especially with NGS.

[0004] One modality for endobronchial biopsy includes endobronchial ultrasound with guided transbronchial needle aspiration (EBUS-TBNA) which utilizes ultrasound guided fine needle aspiration using, e.g., 21-22 gauge needles. However, EBUS-TBNA often yields a relatively small tissue sample and requires multiple punctures with a relatively low NGS success rate.

[0005] Another modality for endobronchial biopsy includes endobronchial ultrasound with guide sheath (EBUS-GS) which utilizes forceps or brushes. The EBUS-GS procedure also often yields a relatively small tissue sample in which the tissue samples are often crushed.

[0006] Yet another modality for endobronchial biopsy includes transbronchial lung cryobiopsy (TBLC). Cryobiopsy sample sizes are generally limited by the size of the cryoprobe and the diameter of the working channel in the bronchoscope. These limitations result in a tissue sample that is a cup-shaped core rather than a solid core and the size of the ice ball formed by the cryoprobe can create excessive bleeding. Furthermore, the use ofAttorney Docket No.: INVNZ00300WQTBLC can results in pneumothorax as well as require additional equipment for use in the procedure.

[0007] Yet another modality for lung biopsy includes transthoracic biopsy, specifically, transthoracic core needle biopsy (TT-CNB) which utilizes, e.g., 18-20 gauge needles. The transthoracic approach results in poor central access and may result in a relatively high rate of pneumothorax as well as excessive bleeding.

[0008] Conventional transbronchial biopsy needles are limited in diameter by the need to maintain flexibility as larger diameters would require the length of the needle bevel to be longer which could result in the needle being unable to be advanced in tight turns within the body or broncoscope.

[0009] Hence, there is a desire to capture relatively large, high quality tissue samples with a low risk of bleeding complications for procedures such as endobronchial biopsy.SUMMARY OF THE INVENTION

[0010] The use of a relatively large coring needle which is able to be advanced within a working channel of a bronchoscope may help to increase the tissue yield and lower the risk of an endobronchial approach. One variation of a biopsy instrument may have a handle and an elongate, flexible shaft removably coupled to the handle. The distal portion of the flexible shaft may include a highly flexible portion which has a column strength which is sufficiently rigid to provide a push force for the coring edge but is also sufficiently flexible to incur one or more bends for traversing a tortuous passageway within the body. Hence, while the flexible shaft may be made of a flexible material such as a polymer, the flexible portion may be fabricated from a metallic material (e.g., stainless steel, nickel-titanium, etc.) which can be configured to bend in any number of directions while maintaining column strength for pushability and torsional strength for transmitting a rotation or torque imparted on the proximal end of the shaft for rotating the coring edge about the longitudinal axis of the shaft. Hence, the flexible portion, for example, may incorporate circumferential cuts or channels (e.g., via laser cutting) to facilitate its bending in any number of directions or in predetermined bending planes.

[0011] The flexible portion may define a lumen which extends through the body of the first shaft for insertion and translation of a trocar stylet instrument which is translatably positioned through the lumen. The trocar stylet instrument may include an elongate, flexible second shaft having a flexible distal portion which may be constructed similarly to flexible portion and terminating in a distal piercing tip. The proximal end of the flexibleAttorney Docket No.: INVNZ00300WQ first shaft may be attached to a translation mechanism located at or near the distal end of the handle. The translation mechanism may be a coupling defining a lumen which passes through the coupling while securing the proximal end of the flexible first shaft to the coupling via any number of attachment mechanisms such as threading, latches, friction fitting, etc. The translation mechanism may accordingly slide over the exterior surface of the flexible second shaft relative to the handle.

[0012] With the coupler attached to the handle and flexible second shaft extending through the lumen, the translation mechanism may be advanced and / or retracted over a limited distance sufficient to advance and / or retract the coring edge relative to the piercing tip. The translation mechanism retracted proximally towards the handle, the piercing tip may be positioned to extend distally out of or proximally into the distal opening of the flexible portion. Accordingly, the piercing tip is able to extend past the coring edge when the translation mechanism is retracted proximally relative to handle, or retracted past the coring edge when translation mechanism is advanced distally relative to handle in a corresponding manner.

[0013] The first shaft and flexible portion may be also coupled with the handle so as to be rotatable about its longitudinal axis relative to the handle. Circumferential rotation of the first shaft may be accomplished by an actuator incorporated within the handle and coupled to the proximal end of first shaft. The actuator may be actuated by an actuator located along the handle which may be used to start or stop the actuator to rotate the first shaft, flexible portionaand coring edge during use. Alternatively, the coring edge may be rotated circumferentially by manually rotating the translation mechanism or the handle. In either case, the coring edge may be rotated in a continuous rotation or in an alternating rotation to provide a sawing motion for cutting through tissue contacted by the coring edge as the handle may be advanced distally in order to advance the coring edge through a tissue sample.

[0014] The handle may further incorporate a suction mechanism such as a syringe attached to the handle by a connector. The suction mechanism may be used to hold onto a cored tissue sample contained within the lumen and / or to draw the cut tissue sample into the lumen.

[0015] While the instrument may be advanced into and through various passageways within the body, the instrument may also be introduced into and through the body through a sheath instrument or endoscopic device. An instrument such as a bronchoscope having a working lumen may be advanced within the airway while the distal end of theAttorney Docket No.: INVNZ00300WQ bronchoscope may be articulated to position its distal end into proximity of a tissue region from which a tissue sample is desired.

[0016] The instrument may be advanced within the working channel of the bronchoscope to follow and conform to the curvature of the bronchoscope distal end for positioning. With the distal end of the bronchoscope positioned to face the tissue region, the flexible portion and flexible distal portion may be advanced distally through the bronchoscope with the piercing tip extended past the coring edge.

[0017] With the piercing tip extended, the biopsy instrument and trocar stylet instrument may be advanced distally through the bronchoscope as the piercing tip pierces through the wall of the airway and against or at least partially into the tissue region of interest until the coring edge is positioned in proximity to, against, or at least partially into the tissue region. The biopsy instrument may be advanced distally by translation mechanism until the coring edge is advanced beyond the piercing tip. The distance by which the coring edge is advanced beyond the piercing tip may define the length of a tissue receiving channel proximal to the coring edge where the cored tissue sample obtained within the tissue receiving channel of the flexible portion has the length of the tissue receiving channel. The piercing tip may function as a stop or block for tissue within the tissue receiving channel of the lumen as the coring edge is advanced within the tissue region.

[0018] With the trocar stylet instrument and piercing tip retracted within the biopsy instrument, the coring edge may be rotated either clockwise, counter-clockwise, or in an alternating sawing manner by actuating the actuator within the handle and / or by manually rotating the handle or first shaft while the coring edge is advanced distally within the tissue region. The coring edge may be sharpened to have a tapered edge or it may be configured to have a serrated edge. In other configurations, the coring edge may be configured to incorporate a radiofrequency element or other heating element for cutting through the contacted tissue and cauterizing the resulting channel to prevent bleeding. The coring edge may be advanced distally within the tissue region by a distance equal to the length by which the piercing tip has been retracted relative to the coring edge as the tissue is collected within the lumen by the advancement of coring edge within the tissue region. The coring edge may also be advanced further within the tissue region to ensure that a sufficient tissue sample has been collected within the lumen.

[0019] Once the tissue sample has been collected, the suction mechanism may be optionally actuated to hold onto the cored tissue sample contained within the lumen and theAttorney Docket No.: INVNZ00300WQ trocar stylet instrument may be retracted from the tissue region. A suction lumen in fluid communication with the suction mechanism may extend through the handle and through the lumen to its distal end. The end of the cored tissue sample may be simply pulled away from the remaining tissue region as the trocar stylet instrument is retracted proximally within the bronchoscope. The resulting cored tissue region may leave a tract of the cored tissue sample as well as an entry tract of the needle piercing tip through the tissue wall of the airway. However, these tracts may be small enough so that the tissue tracts may close upon themselves without any further intervention. The cored tissue sample may be retracted from the patient body by withdrawing the biopsy instrument and trocar stylet instrument from within the bronchoscope or the entire assembly along with the bronchoscope may be withdrawn from the patient body.

[0020] Once the biopsy instrument and trocar stylet instrument are removed from the patient body, the coring edge may be retracted relative to the piercing tip to then push out the cored biopsy sample contained within the lumen, for example, for testing and analysis. As described, the length and diameter of the cored biopsy sample may correspond to the length of the blocked lumen (by the piercing tip) and the inner diameter of the flexible portion.

[0021] In one embodiment of the tissue sampling apparatus, the apparatus may generally comprise a handle, a first shaft having a first distal portion and a first proximal end coupled to a translation mechanism and a rotation mechanism, wherein the first shaft defines a lumen therethrough and is configured for rotational and translational motion, a second shaft having a second distal portion and a second proximal end coupled to the handle, wherein the first shaft is translatably positioned over the second shaft, a coring edge defined upon the first distal portion, wherein the coring edge is configured to cut through a tissue region when rotated about a longitudinal axis of the first shaft, and a piercing tip positioned upon the second distal portion, wherein the first shaft is translatable via the translation mechanism relative to the second shaft such that the piercing tip is positionable from a piercing position where the piercing tip is distal to the coring edge to a retracted position proximal to the coring edge.

[0022] In another aspect of the tissue sampling apparatus, the rotation and translation motion may be independent of one another.

[0023] In another aspect of the tissue sampling apparatus, the piercing tip may be retracted into the proximal position by a distance which defines a tissue receiving channel for receiving a tissue sample.Attorney Docket No.: INVNZ00300WQ

[0024] In another aspect of the tissue sampling apparatus, the first distal portion and the second distal portion may be each configured to conform to a curvature.

[0025] In another aspect of the tissue sampling apparatus, the translation mechanism may be slidably translatable over the second shaft relative to the handle.

[0026] In another aspect of the tissue sampling apparatus, the coring edge may comprise a tapered or serrated edge.

[0027] In another aspect of the tissue sampling apparatus, the piercing tip may comprise a needle tip.

[0028] In another aspect of the tissue sampling apparatus, the apparatus may further comprise a suction mechanism attachable to the handle and in fluid communication with a lumen of the first shaft.

[0029] In another aspect of the tissue sampling apparatus, the coring edge may be manually rotatable about the longitudinal axis.

[0030] In another aspect of the tissue sampling apparatus, the coring edge may be automatically rotatable about the longitudinal axis via an actuator.

[0031] In another aspect of the tissue sampling apparatus, the actuator mechanism may include a drive shaft coupled to an actuator.

[0032] In another aspect of the tissue sampling apparatus, the apparatus may further comprise an endoscopic instrument having a working channel through which the tissue sampling apparatus is positionable.

[0033] Any of the foregoing aspects may be combined in any number of combinations, as practicable, and are intended to be within the scope of this disclosure.

[0034] In one method of sampling tissue, the method may generally comprise advancing a first shaft and a second shaft within a body lumen, the first shaft having a coring edge defined upon a first distal portion of the first shaft and the second shaft having a piercing tip positioned upon a second distal portion of the second shaft, wherein the first shaft is slidably positioned over the second shaft, positioning the piercing tip in proximity of a tissue region such that the coring edge is proximal to, against, or at least partially pierced into the tissue region, advancing the first shaft relative to the second shaft such that the coring edge is advanced distally of the piercing tip and defines a tissue receiving channel, rotating the first shaft about its longitudinal axis while advancing the coring edge at least partially into the tissue region such that a tissue sample is received within the tissue receiving channel, and withdrawing the first shaft and second shaft with the tissue sample retained within the tissue receiving channel.Attorney Docket No.: INVNZ00300WQ

[0035] In another aspect of the method, advancing the first shaft and second shaft may further comprise advancing through a working lumen of an endoscopic instrument.

[0036] In another aspect of the method, advancing through the working lumen may comprise positioning the endoscopic instrument within an airway of a patient body.

[0037] In another aspect of the method, advancing the first shaft may comprise advancing a translation mechanism coupled to a proximal end of the first shaft distally over the second shaft.

[0038] In another aspect of the method, advancing the first shaft and rotating the first shaft may be performed independently of one another.

[0039] In another aspect of the method, advancing the first shaft may comprise advancing the coring shaft distally of the piercing tip by a distance which defines the tissue receiving channel for receiving the tissue sample.

[0040] In another aspect of the method, rotating the first shaft may comprise manually rotating the first shaft about its longitudinal axis.

[0041] In another aspect of the method, rotating the first shaft may comprise automatically rotating the first shaft via an actuator about its longitudinal axis.

[0042] In another aspect of the method, withdrawing the first shaft and second shaft may further comprise applying a suction upon the tissue sample retained within the tissue receiving channel via a suction mechanism.

[0043] In another aspect of the method, the method may further comprise retracting the first shaft relative to the second shaft such that the tissue sample is ejected from the tissue receiving channel.

[0044] Any of the foregoing aspects may be combined in any number of combinations, as practicable, and are intended to be within the scope of this disclosure.BRIEF DESCRIPTION OF THE DRAWINGS

[0045] FIGS. 1A and IB show perspective assembly views, respectively, of the biopsy instrument assembly and flexible trocar through which the biopsy instrument can be advanced.

[0046] FIG. 1C shows a detailed cross-sectional side view of one variation of the distal end of the trocar stylet instrument.

[0047] FIGS. 2A and 2B show perspective views of one variation of an assembly for an actuator which may be located within the handle.Attorney Docket No.: INVNZ00300WQ

[0048] FIG. 2C shows a perspective, partial cross-sectional view of the actuator housing which contains the rotational spring.

[0049] FIGS. 3 A to 3E show one example of how the biopsy instrument may be advanced through the flexible trocar and into a tissue region for obtaining a biopsy tissue sample.

[0050] FIGS. 4A and 4B show side views of an example of a resulting tissue sample retrieved via the biopsy instrument.

[0051] FIGS. 5A to 5C show side views of variations for retaining mechanisms for capturing the tissue sample.

[0052] FIG. 6 shows exemplary cross-sectional end views of the biopsy instrument relative to other conventional biopsy tools for comparison purposes.DETAILED DESCRIPTION OF THE INVENTION

[0053] A biopsy instrument assembly may be used to maximize the quality and quantity of the tissue sample obtained by utilizing a flexible rotating core needle. The instrument may be used in any number of applications where a tissue sample is to be obtained from within a patient body while using a minimally invasive approach. For instance, the instrument assembly may be used to obtain tissue samples from lymph nodes, tumor nodules, etc. Another example of an application is for endobronchial biopsy.

[0054] The use of a relatively large coring needle which is able to be advanced within a working channel, e.g., 2.0 mm diameter, of a bronchoscope may help to lower the risk of an endobronchial approach. FIG. 1 A shows a perspective assembly view of a biopsy instrument 10 having a handle 12 and an elongate, flexible first shaft 14 removably coupled to the handle 12. The distal portion 16 of the flexible first shaft 14 may include a highly flexible portion 18 which has a column strength which is sufficiently rigid to provide a push force for the coring edge 20 but is also sufficiently flexible to incur one or more bends for traversing a tortuous passageway within the body. Hence, while the flexible first shaft 14 may be made of a flexible material such as a polymer, the flexible portion 18 may be fabricated from a metallic material (e.g., stainless steel, nickel-titanium, etc.) which can be configured to bend in any number of directions in a tight bend radius while maintaining column strength for pushability and torsional strength for transmitting a rotation or torque imparted on the proximal end of the first shaft 14 for rotating the coring edge 20 about the longitudinal axis LA of the first shaft 14 (as shown in FIG. 3D). Hence, the flexible portion, for example, may incorporate circumferential cuts or channels (e.g., via laserAttorney Docket No.: INVNZ00300WQ cutting) to facilitate its bending in any number of directions or in predetermined bending planes.

[0055] The flexible portion 18 may define a lumen L which extends through the body of the first shaft 14 for insertion and translation of a trocar stylet instrument 32, as shown in the perspective view of FIG. IB, which is translatably positioned through the lumen L.The trocar stylet instrument 32 may include an elongate, flexible second shaft 34 having a flexible distal portion 36 which may be constructed similarly to flexible portion 18 and terminating in a distal piercing tip 22. The proximal end of the flexible first shaft 14 may be attached to a translation mechanism 24 located at or near the distal end of the handle 12. The translation mechanism 24 may be a coupling defining a lumen which passes through the coupling while securing the proximal end of the flexible first shaft 14 to the coupling via any number of attachment mechanisms such as threading, latches, friction fitting, etc. The translation mechanism 24 may accordingly slide over the exterior surface of the flexible second shaft 34 relative to the handle 12.

[0056] FIG. 1C shows a detailed cross-sectional side view of one variation of the distal end of the trocar stylet instrument 32 illustrating how the piercing tip 22 of the needle may extend or project from an elongate needle body 23. The needle body 23 may be contained within a spacer member 21 having an elongate body and an annular lumen through which the needle body 23 may be supported. The distal end of the spacer member 21 may also be tapered so as to function as a dilator as the piercing tip 22 is advanced into a tissue region. The needle body 23 and piercing tip 22 may be attached to one another so as to translate as a unit through the lumen L of flexible portion 18 or they may be translatable independently of one another if so desired. The spacer member 21 may maintain the piercing tip 22 to translate along the longitudinal axis of the flexible portion 18.

[0057] With the coupler 38 attached to the handle 12 and flexible second shaft 34 extending through the lumen L, the translation mechanism 24 may be advanced and / or retracted over a limited distance sufficient to advance and / or retract the coring edge 20 relative to the piercing tip 22. The translation mechanism 24 retracted proximally towards the handle 12, the piercing tip 22 may be positioned to extend distally out of or proximally into the distal opening of the flexible portion 18. Accordingly, the piercing tip 22 is able to extend past the coring edge 20 when translation mechanism 24 is retracted proximally relative to handle 12, or retracted past the coring edge 20 when translation mechanism 24 is advanced distally relative to handle 12 in a corresponding manner. Furthermore, the coring edge 20 may be coupled to the actuator AC to provide not only rotational movement, butAttorney Docket No.: INVNZ00300WQ also translational movement which may be provided independently of one another or in combination with one another. For example, distal translation of the coring edge 20 may also trigger a corresponding rotational motion provided by the actuator AC or a rotational motion may trigger a corresponding translational movement of the coring edge 20.

[0058] The first shaft 14 and flexible portion 20 may be also coupled with the handle 12 so as to be rotatable about its longitudinal axis LA relative to the handle 12. Circumferential rotation of the first shaft 14 may be accomplished by an actuator AC (e.g., torsion spring, electric motor, compressed air motor, etc.) incorporated within the handle 12 and coupled to the proximal end of first shaft 14. The actuator AC may be actuated by an actuator 26 located along the handle 12 which may be used to start or stop the actuator AC to rotate the first shaft 14, flexible portion 18 and coring edge 20 during use. Alternatively, the coring edge 20 may be rotated circumferentially by manually rotating the translation mechanism 24 or the handle 12. In either case, the coring edge 20 may be rotated in a continuous rotation or in an alternating rotation to provide a sawing motion for cutting through tissue contacted by the coring edge 20 as the handle 12 may be advanced distally in order to advance the coring edge 20 through a tissue sample. Furthermore, the flexible second shaft 34 and piercing tip 22 may also be rotatable about its longitudinal axis by the actuator AC as well. The actuator AC may be coupled to the piercing tip 22 to provide both axial motion as well as rotational motion independently of one another or in a corresponding motion.

[0059] FIGS. 2A and 2B show perspective views of one variation of an assembly for an actuator AC which may be located within the handle where the first shaft 14 (and / or second shaft 34 in other variations) may be coupled to a drive shaft 41 through a drive shaft coupler 43 through which the proximal end of the first shaft 14 and the drive shaft 41 may be supported and may be rotatable. The drive shaft coupler 43 may be configured as a cylindrical housing structure which supports the first shaft 14 for rotation about its longitudinal axis and may further include a stop 45 coupled to the drive shaft 41 and / or first shaft 14 at its proximal end through the drive shaft coupler 43. The stop 45 is configured in this variation as a cylindrical structure having one or more openings 47 defined about the circumferential surface of the stop 45. The one or more openings 47 may be defined at uniform positions about the circumferential surface and may be sized for engagement with a retractable projection which may extend from a pivoting brake structure 53 for insertion and removal from the one or more openings 47 to allow for or prevent the rotation of the drive shaft 41 and first shaft 14 as it rotates with the stop 45 in a corresponding manner.Attorney Docket No.: INVNZ00300WQ

[0060] An actuator housing 51 may support the drive shaft coupler 43 and may also house an actuator within the actuator housing 51. The actuator within the housing 51 may rotate within the structure and may be coupled to a primary gear 57 which may be rotatingly engaged with one or more secondary gears 49, for example, one or more pinion gears (or other gear types). The secondary gears 49 may contact and engage with the drive shaft 41 and transfer the rotation from the primary gear 57 to the first shaft 14 while the second gears 49 may be configured to alter the gear ratio from the actuator within the housing 51 to a stepped down (or stepped up) rotation of the first shaft 14 (and / or piercing tip 22).

[0061] The pivoting brake structure 53 may rotate about a pivot or hinge 59 supported by the actuator housing 51 for positioning the pivoting brake structure 53 into an engaged position with one of the openings 47, which prevents rotation of the stop 45 and first shaft 14, or into a disengaged position with one of the openings 47, which allows for the free rotation of the stop 45 and first shaft 14.

[0062] One variation of the actuator AC may incorporate a rotational spring 61 housed within the actuator housing 51 to function as the drive mechanism. FIG. 2C shows a perspective, partial cross-sectional view of the actuator housing 51 which contains the rotational spring 61, such as wound spring element or ribbon spring which may be rotated into a wound configuration for storing potential energy within the spring. Rotation of the spring 61 may be accomplished by rotating a knob or handle 55 which may also be coupled to the primary gear 57 via a shaft which may extend from the gear 57, through the actuator housing 51 and into engagement with the knob or handle 55. The knob or handle 55 may be rotated in a first direction to wind the spring 61 within the actuator housing 51. Once completed, the stop 45 may be engaged to prevent the unwinding of the spring 61 , first shaft 14, and coring edge 20. The pivoting brake structure 53 may be released to allow for the unwinding of the spring 61 which in turn enables the rotation of the primary gear 57, first shaft 14, and coring edge 20 during use, as described in further detail herein, in a second direction opposite to the first direction. Additionally, the coring edge 20 may also be rotated by hand about its longitudinal axis by manually turning the knob or handle 55 with the stop 45 released.

[0063] Additionally, a mechanism such as a flywheel may also be optionally incorporated into the actuator AC and coupled to the primary gear 57 (for example, through a clutch mechanism) to provide additional inertia when cutting through the tissue either with the coring edge 20 or piercing tip 22.Attorney Docket No.: INVNZ00300WQ

[0064] The handle 12 may further incorporate a suction mechanism 28 such as a syringe attached to the handle 12 by a connector 30. The suction mechanism 28 may be used to hold onto a cored tissue sample contained within the lumen L and / or to draw the cut tissue sample into the lumen L.

[0065] FIGS. 3A to 3E illustrate one method for removing a tissue sample using the biopsy instrument 10. While the instrument 10 may be advanced into and through various passageways within the body, the instrument 10 may also be introduced into and through the body through a sheath instrument or endoscopic device. FIG. 3A shows one application of the device advanced within an airway passage P of a lung within a patient body. An instrument such as a bronchoscope 40 having a working lumen may be advanced within the airway P while the distal end 42 of the bronchoscope 40 may be articulated to position its distal end 42 into proximity of a tissue region T from which a tissue sample is desired. Although the bronchoscope 40 is shown in this example, the instruments shown and described may be used with any number of other devices such as different endoscopic devices which may be manually or automatically controlled through a robotic system.Examples of such robotic systems may include, for example, the MONARCH Bronchoscope (Ethicon, Inc., Raritan, NJ) or the ION robotic bronchoscopy system (Intuitive Surgical, Inc., Sunnyvale, CA).

[0066] The instrument 10 may be advanced within the working channel of the bronchoscope 40 and the instrument 10 is shown to have sufficient flexibility, particularly along its distal flexible portions, to follow and conform to the curvature of the bronchoscope distal end 42 for positioning. With the distal end 42 of the bronchoscope 40 positioned to face the tissue region T, the flexible portion 18 and flexible distal portion 36 may be advanced distally through the bronchoscope 40 with the piercing tip 22 extended past the coring edge 20.

[0067] With the piercing tip 22 extended, the biopsy instrument 10 and trocar stylet instrument 32 may be advanced distally through the bronchoscope 40 as the piercing tip 22 pierces through the wall of the airway P and against or at least partially into the tissue region T of interest, as shown in FIG. 3B, until the coring edge 20 is positioned in proximity to, against, or at least partially into the tissue region T. The biopsy instrument 10 may be advanced distally by translation mechanism 24 until the coring edge 20 is advanced beyond the piercing tip 22, as shown in FIG. 3C. The distance by which the coring edge 20 is advanced beyond the piercing tip 22 may define the length of a tissue receiving channel proximal to the coring edge 20 where the cored tissue sample obtainedAttorney Docket No.: INVNZ00300WQ within the tissue receiving channel of the flexible portion 18 has the length of the tissue receiving channel. This distance may be preset via a depth stop using the actuator AC or through a projection or shoulder defined along the proximal end of the shafts. The piercing tip 22 may function as a stop or block for tissue within the tissue receiving channel of the lumen L as the coring edge 20 is advanced within the tissue region T.

[0068] With the trocar stylet instrument 32 and piercing tip 22 retracted within the biopsy instrument 10, the coring edge 20 may be rotated either clockwise, counterclockwise, or in an alternating sawing manner by actuating the actuator AC within handle 12 and / or by manually rotating the handle or first shaft 14 while the coring edge 20 is advanced distally within the tissue region T, as shown in FIG. 3D. The coring edge 20 may be sharpened to have a tapered edge or it may be configured to have a serrated edge. In other configurations, the coring edge 20 may be configured to incorporate a radiofrequency element or other heating element for cutting through the contacted tissue. The coring edge 20 may be advanced distally within the tissue region T by a distance equal to the length by which the piercing tip 22 has been retracted relative to the coring edge 22 as the tissue is collected within the lumen L by the advancement of coring edge 22 within the tissue region T. The coring edge 20 may also be advanced further within the tissue region T to ensure that a sufficient tissue sample has been collected within the lumen L.

[0069] Once the tissue sample has been collected, the suction mechanism 28 may be optionally actuated to hold onto the cored tissue sample contained within the lumen L and the trocar stylet instrument 32 may be retracted from the tissue region T. A suction lumen in fluid communication with the suction mechanism 28 may extend through the handle 12 and through the lumen L to its distal end. The end of the cored tissue sample may be simply pulled away from the remaining tissue region T as the trocar stylet instrument 32 is retracted proximally within the bronchoscope 40. The resulting cored tissue region T may leave a tract 46 of the cored tissue sample as well as an entry tract 48 of the needle piercing tip 22, as shown in FIG. 3E, through the tissue wall of the airway P. However, these tracts 46, 48 may be small enough so that the tissue tracts may close upon themselves without any further intervention, as shown in FIG. 3E. The cored tissue sample may be retracted from the patient body by withdrawing the biopsy instrument 10 and trocar stylet instrument 32 from within the bronchoscope 40 or the entire assembly along with the bronchoscope 40 may be withdrawn from the patient body.

[0070] Once the biopsy instrument 10 and trocar stylet instrument 32 are removed from the patient body, the coring edge 20 may be retracted relative to the piercing tip 22 to thenAttorney Docket No.: INVNZ00300WQ push out the cored biopsy sample B contained within the lumen L, as shown in the side view of FIG. 4A, for example, for testing and analysis. As described, the length and diameter of the cored biopsy sample B may correspond to the length of the blocked lumen L (by the piercing tip 22) and the inner diameter of the flexible portion 18, as shown in the side view of FIG. 4B.

[0071] Other variations for retaining the cored biopsy sample B within the lumen L may include mechanical features such as tabs 50 which are cut from the walls of the flexible portion 18 to extend or angle inwardly into the interior of the lumen L. The tabs 50 may be angled to extend away from the opening of the flexible portion 18 so as function as a barb for engaging the tissue sample contained within, as shown in the side view of FIG. 5A. Another variation may include a distal region 52 of the flexible portion 18 which is tapered or necked down to a reduced inner diameter, as shown in the side view of FIG. 5B, so that the tissue sample entering into the lumen L may be compressed slightly against the inner walls of the flexible portion 18 as it enters within the lumen L. Yet another variation is shown in FIG. 5C which shows one or more openings 54 which may be formed or defined along the side walls of the lumen L to allow for the tissue sample within to expand outwardly at least partially through the one or more openings 54 thereby helping to secure the tissue sample within the lumen L.

[0072] FIG. 6 illustrates an example of the cross-sectional end view of flexible portion 18 to illustrate the cross-sectional area of lumen L. As the outer diameter of the flexible portion 18 may be sized to translate within the working channel of an endoscopic device or sheath, the outer diameter may be sized to be no greater than, for example, 2.0 mm. This may result in a flexible portion 18 inner diameter of, for example, 1.75 mm. The length of the defined lumen L interior length may be, for example, 1.0 cm to 5.0 cm, so that a resulting cored biopsy sample B having an outer diameter of about 1.75 mm and a length of about 1.0 cm to 5.0 cm may be obtained. The size of the resulting cored biopsy sample B may be, for example, as much as 15 times the tissue collection size of other conventional biopsy collection sizes, as shown in the comparison with the diameters of other biopsy devices where the inner diameters may range from 0.53 mm, 0.64 mm, or 0.81 mm.

[0073] The applications of the devices and methods discussed above are not limited to endobronchial biopsy procedures as described but may include any number of biopsy or tissue sampling applications. Modification of the above-described assemblies and methods for carrying out the invention, combinations between different variations as practicable,Attorney Docket No.: INVNZ00300WQ and variations of aspects of the invention that are obvious to those of skill in the art are intended to be within the scope of the claims.

Claims

Attorney Docket No.: INVNZ00300WQCLAIMSWhat is claimed is:

1. A tissue sampling apparatus, comprising: a handle; a first shaft having a first distal portion and a first proximal end coupled to a translation mechanism and a rotation mechanism, wherein the first shaft defines a lumen therethrough and is configured for rotational and translational motion; a second shaft having a second distal portion and a second proximal end coupled to the handle, wherein the first shaft is translatably positioned over the second shaft; a coring edge defined upon the first distal portion, wherein the coring edge is configured to cut through a tissue region when rotated about a longitudinal axis of the first shaft; and a piercing tip positioned upon the second distal portion, wherein the first shaft is translatable via the translation mechanism relative to the second shaft such that the piercing tip is positionable from a piercing position where the piercing tip is distal to the coring edge to a retracted position proximal to the coring edge.

2. The apparatus of claim 1 wherein the rotation and translation motion are independent of one another.

3. The apparatus of claim 1 wherein the piercing tip is retracted into the proximal position by a distance which defines a tissue receiving channel for receiving a tissue sample.

4. The apparatus of claim 1 wherein the first distal portion and the second distal portion are each configured to conform to a curvature.

5. The apparatus of claim 1 wherein the translation mechanism is slidably translatable over the second shaft relative to the handle.

6. The apparatus of claim 1 wherein the coring edge comprises a tapered or serrated edge.

7. The apparatus of claim 1 wherein the piercing tip comprises a needle tip.Attorney Docket No.: INVNZ00300WQ8. The apparatus of claim 1 further comprising a suction mechanism attachable to the handle and in fluid communication with a lumen of the first shaft.

9. The apparatus of claim 1 wherein the coring edge is manually rotatable about the longitudinal axis.

10. The apparatus of claim 1 wherein the coring edge is automatically rotatable about the longitudinal axis via an actuator mechanism.

11. The apparatus of claim 10 wherein the actuator mechanism includes a drive shaft coupled to an actuator.

12. The apparatus of claim 1 further comprising an endoscopic instrument having a working channel through which the tissue sampling apparatus is positionable.

13. A method of sampling tissue, comprising: advancing a first shaft and a second shaft within a body lumen, the first shaft having a coring edge defined upon a first distal portion of the first shaft and the second shaft having a piercing tip positioned upon a second distal portion of the second shaft, wherein the first shaft is slidably positioned over the second shaft; positioning the piercing tip in proximity of a tissue region such that the coring edge is proximal to, against, or at least partially pierced into the tissue region; advancing the first shaft relative to the second shaft such that the coring edge is advanced distally of the piercing tip and defines a tissue receiving channel; rotating the first shaft about its longitudinal axis while advancing the coring edge at least partially into the tissue region such that a tissue sample is received within the tissue receiving channel; and withdrawing the first shaft and second shaft with the tissue sample retained within the tissue receiving channel.

14. The method of claim 13 wherein advancing the first shaft and second shaft further comprises advancing through a working lumen of an endoscopic instrument.Attorney Docket No.: INVNZ00300WQ15. The method of claim 14 wherein advancing through the working lumen comprises positioning the endoscopic instrument within an airway of a patient body.

16. The method of claim 13 wherein advancing the first shaft comprises advancing a translation mechanism coupled to a proximal end of the first shaft distally over the second shaft.

17. The method of claim 13 wherein advancing the first shaft and rotating the first shaft are performed independently of one another.

18. The method of claim 13 wherein advancing the first shaft comprises advancing the coring shaft distally of the piercing tip by a distance which defines the tissue receiving channel for receiving the tissue sample.

19. The method of claim 13 wherein rotating the first shaft comprises manually rotating the first shaft about its longitudinal axis.

20. The method of claim 13 wherein rotating the first shaft comprises automatically rotating the first shaft via an actuator about its longitudinal axis.

21. The method of claim 13 wherein withdrawing the first shaft and second shaft further comprises applying a suction upon the tissue sample retained within the tissue receiving channel via a suction mechanism.

22. The method of claim 13 further comprising retracting the first shaft relative to the second shaft such that the tissue sample is ejected from the tissue receiving channel.

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