JP2014221403A - Biopsy sample storage assembly - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a biopsy device in which a plurality of tissue samples can be separately and consecutively stored in a part of the biopsy device.SOLUTION: A biopsy device includes: a rotary member disposed to a proximal side of a cannula; and a plurality of tissue sample holders 2200 removably held by the rotary member. Each of the tissue sample holders is composed to receive at least one tissue sample excised by a cutter, and each of the tissue sample holders is removable from the rotary member while the rotary member is supported by the biopsy device.

Description

Disclosure details

〔priority〕
This application claims priority to US Provisional Patent Application No. 60 / 869,736 filed on December 13, 2006 and 60 / 874,792 filed on December 13, 2006. And are hereby incorporated by reference with reference to these patent applications.

〔background〕
Some embodiments of the present invention generally relate to a biopsy device, and more particularly, a biopsy device capable of storing multiple tissue samples in series spaced apart within a portion of the biopsy device. About.

  If a suspicious tissue mass is found in a patient's breast or other site by examination, ultrasound, MRI, X-ray imaging, or the like, to determine whether the tissue mass contains cancerous cells A biopsy needs to be performed to collect one or more tissue samples from the tissue mass. A biopsy can be performed by open or transdermal methods. Medical devices for obtaining tissue samples for later sampling and / or examination are well known in the biopsy field. For example, the MAMMOTOME brand name biopsy instrument used to obtain a breast biopsy sample is commercially available from Ethicon Endo-Surgery, Inc.

  In an open biopsy, a large incision is made in the breast to remove the entire tissue mass (called an ablation biopsy) or a substantial portion of the tissue mass (known as an incision biopsy) . An open biopsy is a surgical procedure commonly performed as a procedure for outpatients in a hospital or surgical center, and is costly and traumatic to the patient. Open biopsy has a higher risk of infection and bleeding than percutaneous biopsy, and traumatic deformation that can occur with open biopsy can make subsequent examination of mammograms difficult. Furthermore, considering the patient's aesthetics, open biopsy is not attractive due to the risk of deformation due to trauma. Because biopsy shows that the suspicious tissue mass is not cancerous, open biopsy treatment is not appropriate in some cases due to its downsides.

  Percutaneous biopsy is less invasive than open biopsy. Percutaneous biopsy can be performed by fine needle aspiration (FNA) or core biopsy. In FNA, fluid and cells can be sucked and sucked from a suspected tissue mass using an extremely thin needle. In this method, the local anesthesia is so much less painful that the pain may be greater than the FNA itself, and the local anesthesia is not necessarily performed. However, certain FNA treatments are relatively less useful in analyzing suspicious tissue and assessing cancer progression when a sample is confirmed malignant because only a small amount of cells can be collected in a single treatment.

  In certain core biopsies, a small tissue sample can be taken for pathological assessment of the tissue, including assessment of the progression of any cancer cells found.

  A biopsy instrument under the trade name MAMMOTOME is sold by Ethicon Endo-Surgery, Inc. This biopsy instrument typically takes multiple core biopsy samples using aspiration with a single puncture into breast tissue. Specifically, the cutter tube advances through the probe to cut the tissue drawn into the side opening by aspiration, and then the cutter is completely pulled back from the excision position to collect the sample.

In an apparatus in which the moving distance of the cutter is relatively long, the sample collection speed is limited not only by the time required for rotating and rearranging the probe, but also by the time required for moving the cutter. As an alternative to a relatively “long stroke” biopsy device, a “short stroke” biopsy device is disclosed in the following self-patent application, the disclosure of which is incorporated herein by reference. US Patent Application No. 10 / 676,944 by Hibner et al. Filed Sep. 30, 2003 (name: internal sample) published as US Published Patent Application No. 2005/0215921 Biopsy instrument with collection mechanism “(Biopsy Instrument with Internal Specimen Collection Mechanism)”)
US patent application Ser. No. 10 / 732,843 by Cicenas et al. Filed Dec. 10, 2003, published as US published patent application No. 2004/0153003 (name: “sample tube Biopsy Device with Sample Tube ”)
Sample time can be reduced by allowing the cutter to travel a distance substantially equal to or slightly shorter than the side opening distance.

The following patent documents disclose various biopsy devices, which are incorporated herein by reference in their entirety.
・ US Pat. No. 6,273,862 issued on August 14, 2001 ・ US Pat. No. 6,231,522 issued on May 15, 2001 ・ US issued on May 8, 2001 Patent No. 6,228,055 ・ US Pat. No. 6,120,462 issued on September 19, 2000 ・ US Pat. No. 6,086,544 issued on July 11, 2000・ US Patent No. 6,077,230 issued on June 20, 2000 ・ US Patent No. 6,017,316 issued on January 25, 2000 ・ US issued on December 28, 1999 Patent No. 6,007,497 ・ US Pat. No. 5,980,469 issued on Nov. 9, 1999 ・ US Pat. No. 5,964,716 issued on Oct. 12, 1999・ December 27, 1999 US Pat. No. 5,928,164, US Pat. No. 5,775,333 issued July 7, 1998, US Pat. No. 5,769,086 issued June 23, 1998 Description: US Pat. No. 5,649,547 issued July 22, 1997 US Pat. No. 5,526,822 issued July 18, 1996 Specification published on October 23, 2003 US Pat. No. 2003/0199753 by Hibner et al. US Pat. No. 5,526,822, the disclosure of which is incorporated herein by reference, includes a belt-driven rotating sample cassette A tissue sample cassette is disclosed. Another tissue sample storage device is published as published patent application 2006/0074343, US patent application Ser. No. 10/953, filed Sep. 29, 2004, the disclosure of which is incorporated herein by reference. No. 395 (name: “Biopsy Device with Sample Storage”) and published patent application No. 2007/0032741, filed on Aug. 8, 2005 US patent application Ser. No. 11 / 198,558, entitled “Biopsy Device with Replaceable Probe and Incorporating Vibration. Insertion Assist and Static Vacuum Source Sample Stacking Retrieval))).

  Although various biopsy devices have been manufactured and used, and various tissue sample storage devices and techniques have been devised, prior to the present invention, the biopsy system disclosed in the appended claims was manufactured or used. It seems not to have been.

[Detailed explanation]
This specification is complete with the claims that particularly point out and distinctly claim the invention, but the following detailed description should be read with reference to the accompanying drawings. The invention will be better understood.

  FIG. 1 shows a biopsy device 10 according to one embodiment of the present invention. The biopsy device 10 of this example includes a handpiece, generally designated as reference numeral 30. The handpiece 30 can be easily held with one hand and can be operated with one hand. The biopsy device 10 can include a tissue penetration such as a cannula 100 extending distally from the handpiece 30. Cannula 100 can include a distal tissue piercing tip 110 and a transverse tissue receiving opening 114 spaced proximally from the tip 110. Cannula 100 can be inserted into a tissue mass to be sampled. The tissue drawn into the opening 114 can then be excised by the distal end 122 of the tube cutter 120 (FIG. 2) moving through the cannula 100.

  The biopsy device 10 of this example also includes a tissue storage assembly 2000 that can be placed at the proximal end of the handpiece 30 proximal to the cutter 120. The tissue storage assembly 2000 can include a substantially transparent cover 2010. The cover 2010 can be removably connected to the biopsy device 10, such as at the proximal end of the handpiece 30. Of course, the cover 2010 can be substantially translucent, opaque, a combination of transparent and opaque, etc., and can have any other suitable properties. The cover 210 can be removably connected to the proximal end of the handpiece 30 by any suitable attachment mechanism or functional structure including, but not limited to, snap-fits, plugs, screw connections, and the like. In FIG. 1, the cover 2010 includes a flange 2012 that allows a detachable snap fit with the proximal end of the handpiece 30.

  The illustrated tissue storage assembly 2000 also includes at least one tissue holder 2200 disposed within the removable cover 2010. The holder 2200 is detachably held by the rotating member. In this example, the rotating member is in the form of a manifold 2300 (FIG. 7), but other structures or configurations may be used. The manifold 2300 can be at least partially disposed within the cover 2010. The tissue sample holder 2200 may have a shape or other structure configured to hold a plurality of tissue samples (generally indicated by reference numeral 42) excised by the cutter 120 in series and spaced apart. it can.

  As will be described later, the rotary manifold 2300 and the tissue holder 2200 of this example can be automatically rotated by adjusting the rotational position by incrementing a predetermined angle each time the tissue sample 42 is excised. If the user does not want automatic alignment, a manual rotation knob 2020 can be provided so that the manifold 2300 and tissue holder 2200 can be rotated manually. The tissue storage assembly 2000 may also include an actuator, such as a control lever 2040, for selecting the direction of rotational alignment (clockwise or counterclockwise) of the rotary manifold 2300 and tissue holder 2200 within the transparent cover 2010. it can. Of course, as with other components disclosed herein, the knob 2020 and lever 2040 are merely optional and can be changed, replaced, supplemented, or removed as desired.

  2-5 illustrate a series of operations of a biopsy device utilizing a tissue storage assembly 2000 according to one embodiment of the present invention. 2-5, the tissue storage assembly 2000 has the cover 2010 removed as shown. 6-8 illustrate details of the tissue storage assembly 2000 of this example.

  Referring now to FIG. 2, the internal components of an exemplary biopsy device 10 suitable for use in a localization method are shown. In FIG. 2, the cannula 100 is shown in a “fire” position that coincides with the cannula 100 guided into the tissue by the firing mechanism 150. The firing assembly 150 of this example includes a launching fork 152 that can be hammered, such as by a manual hammering device or hammering motor 156, with the firing energy stored in the firing spring 158. Alternatively, the firing assembly 150 may have any other suitable structure or may be omitted entirely.

  In this example, the tube cutter 120 is disposed within the cutter lumen 104 of the cannula 100. In FIG. 2, the cutter 120 is shown in a retracted position, with the distal cutting end 122 (shown in broken lines) of the cutter 120 just proximal to the tissue receiving opening 114 of the cannula 100. Has been placed. Once the cannula 100 is placed in the tissue, the cutter 120 is pulled back to the position shown in FIG. 2 in an exemplary mode of operation.

  Referring now to FIGS. 2 and 2A, the cannula 100 can include a vacuum lumen 108 located below the cutter lumen 104. When the cannula 100 is placed in the tissue and the cutter 120 is in the retracted position shown in FIG. 2, the vacuum lumen 108 in this example is immediately adjacent to the port opening 114 via a plurality of passages 107 (FIG. 13). A vacuum is applied to the lower cutter lumen 104 to assist in drawing tissue into the port 114. The cutter 120 extends from the distal cutting end 122 to the cutter proximal end 124. Cutter 120 includes a cutter 120, a vacuum manifold 300, a saline / vacuum valve assembly 4080, with an intermediate portion between distal cutting end 122 and proximal end 124 passing through cutter lumen 104 of cannula 100. And the cutter gear 410.

  In this example, the proximal end 124 of the cutter 120 is in communication with the distal end of the tissue sample transfer tube 2030. The sample transfer tube 2030 is flexible connected to the proximal end 124 of the cutter 120 by a slip joint 2028 or other suitable connection that allows relative axial movement and rotation of the cutter end 124 relative to the tube 2030. Sex tube. The proximal end of the sample transfer tube 2030 is in communication with the tissue sample port 2057 of the proximal cover 2050 of the tissue storage assembly 2000. Proximal cover 2050 covers the proximal end of tissue storage assembly 2000. Proximal cover 2050 and substantially transparent cover 2010 together provide a tissue storage chamber in which manifold 2300 and tissue holder 2200 are at least partially disposed. A port 2057 and a vacuum port 2060 for supplying a vacuum to the manifold 2300 can be integrally formed with the cover 2050. However, from this disclosure, the sample transfer tube 2030 can be modified, replaced, supplemented, or omitted as desired, and various other to obtain communication between the cutter 120 and the tissue storage assembly 2000. It will be appreciated that the following components or structures may be used.

  The tissue sample 42 excised by the cutter 120 can be transferred through the cutter 120 and the sample transfer tube 2030 and placed in the tissue storage chamber of the tissue storage assembly 2000. Vacuum may be supplied to the tissue storage assembly 2000 from a vacuum source through the vacuum port 2060 of the cover 2050 or otherwise. In this example, the tissue sample 42 that enters the tissue storage chamber via the port 2057 of the cover 2050 is placed in the tissue holder 2200.

  The proximal cover 2050 can also include an access opening 2052, as shown in FIG. The teeth 2354 of the manifold rotation gear 2350 can engage the alignment pawl 2362 through the opening 2052. Manifold rotating gear 2350 can be coupled to manifold 2300 by spline coupling or other suitable coupling such that rotation of gear 2350 causes manifold 2300 to rotate.

  In this example, the proximal cover 2050 is a mating half of the body of the biopsy device 10 such that the cover 2050 can rotate about the central axis of the longitudinal axis 2055 (FIG. 6) of the tissue storage assembly 2000. And a flange 2056 that can be held between the halves (not shown). The lever 2040 can be used to rotate the cover 2050 (and the access opening 2052) circumferentially from the 1 o'clock position to the 2 o'clock position. When the lever 2040 is in the position shown in the drawings (eg, FIGS. 1 and 6), the pawl 2362 engages the tooth 2354 through the opening 2052. When the lever 2040 is repositioned at the other end of the outer cover slot 62 of the biopsy device (FIG. 1), the cover 2050 and access opening 2052 rotate and the pawl 2364 engages the teeth 2354. A claw 2362 allows alignment rotation of the manifold 2300 in one direction about the axis 2055 and a claw 2364 allows alignment rotation of the manifold 2300 in the opposite direction about the axis 2055.

  By changing the position of lever 2040, the entry point of tissue sample 42 into tissue storage assembly 2000 is also changed in this example. When the position of the lever 2040 is changed, the position of the port 2057 moves in the circumferential direction, and the transfer tube 2030 corresponds to this movement. The tissue sample entry point is offset from the 12 o'clock position (directly above) in the illustrated embodiment. The lever 2040 is used to select the tissue entry point at either about the 2 o'clock position or about the 10 o'clock position, and the operator using the biopsy device 10 in a stereotaxic environment enters the sample tissue storage assembly 2000. Can be seen through the transparent cover 2010 of this assembly 2000. At this time, the upper part of the biopsy device 10 can be disposed close to the lower surface of the stereotaxic table.

  It should be understood that any other suitable structure or device may be used in place of or in addition to lever 2040 to reposition port 2057. For example, port 2057 can be selectively relocated using one or more motors or transmissions. Alternatively, the circumferential or angular position port 2057 can be substantially fixed (eg, 12 o'clock position, etc.). Similarly, the nails 2362, 2364 can be changed, replaced, complemented, or omitted as desired.

  Referring again to FIG. 2, a cutter lead screw 510 rotated by the cutter motor 500 is supported by the biopsy device 10. As the lead screw 510 rotates, the cutter carriage nut 520 moves forward or backward with respect to the screw 510 according to the rotation direction. The nut 520 can be attached to or integral with the cutter carriage 530. In this example, the cutter 120 is rotatably supported by the carriage 530 such that the cutter carriage is rotated by the gear 410 when the cutter carriage moves the cutter 120. The movement of the nut 520 relative to the screw 510 causes the carriage 530 and the cutter 120 to move in the axial direction of either the proximal side (retracting) or the distal side (advancing) depending on the rotational direction of the motor 500 and the screw 510. When the cutter rotating gear 410 is engaged with the drive gear 512, the cutter 120 rotates about its axis by the cutter rotating gear 410. The rotation of the drive gear 512 can also be performed by the motor 500. Therefore, the cutter 120 can be rotated and moved simultaneously by the operation of the motor 500. In FIG. 2, the cutter carriage nut 520 is shown in a proximal (retracted) position that coincides with the distal end 122 of the cutter 120 disposed just proximal to the opening 114.

  As shown in FIG. 2, a claw 2362 is rotatably attached to the claw thread 2360. In FIG. 2, the claw thread 2360 is shown in its most proximal position. The claw thread 2360 is pushed proximally by the tab extension 522 of the carriage nut 520. The thread spring 2361 is compressed by the proximal movement of the thread 2360. The compressed thread spring 2361 can be used to bias the thread 2360 distally as the nut 520 and tab extension 522 are advanced distally with respect to the lead screw 510 (thread advancement). . Of course, the spring 2361 can be omitted or changed as desired.

  In the position shown in FIG. 2, the biopsy device 10 is ready to take a tissue sample 42. The vacuum control module 5000 (FIG. 15) can supply a vacuum to the vacuum lumen 108 to draw tissue into the opening 114. Referring to FIG. 3, the cutter 120 is advanced to its distal most position to excise the tissue sample 42 and extends across the opening 114 of the cannula 100 as shown. Is closed. When the cutter 120 advances from the position of FIG. 2 to the position of FIG. 3, the cutter 120 also rotates by the operation of the cutter rotation gear 410 that is rotated by the drive gear 512. In FIG. 3, the carriage 530 and the cutter 120 are advanced by the movement of the nut 520 relative to the screw 510. As the nut 520 moves distally, the tab extension 522 also moves distally and the pawl thread 2360 is pushed distally by the extension of the spring 2361. As the cutter 120 moves distally from the position shown in FIG. 2 to the position shown in FIG. 3, the pawl 2362 is disengaged from and moved over the teeth 2354 of the manifold gear 2350. .

  Referring now to FIG. 4, the excised tissue sample 42 is placed on the tissue holder 2200 via the sample transfer tube 2030. In transferring the excised tissue sample 42 from the cannula 100 to the tissue storage assembly 2000, the vacuum in the vacuum lumen 108 is applied with the cutter 120 covering the tissue receiving opening 114 at its distal most position. Turn off and supply atmospheric pressure to the vacuum lumen 108 using a vacuum control valve. In addition or alternatively, saline can be supplied. Using the valve configuration, saline is supplied distally through the vacuum lumen 108 of the cannula 100 to one or more holes or passages 107, and the cutter lumen at the distal end of the cannula 100. Fluid can be communicated between 104 and vacuum lumen 108. The saline flow, and / or atmospheric pressure exerts a proximal force on the tissue sample excised by the cutter 120, so that the excised tissue sample disposed at the distal portion of the cutter 120 is Pushed proximally.

  In addition, a tissue storage vacuum source that provides vacuum to the vacuum port 2060 can be provided. The vacuum supplied to port 2060 passes through tissue storage assembly 2000 and is supplied to cutter 120 via sample transfer tube 2030. Thus, the vacuum supplied to the port 2060 applies a proximal pulling force on the excised tissue sample in the cutter 120. The combination of proximal pushing and pulling forces on the resected tissue sample allows the tissue sample 42 to be removed from the cutter 120 (from the cutter distal end 122 to the cutter proximal end 124) and the sample transfer tube 2030 ( The portion of the tissue holder 2200 (recessed) that is transferred into the tissue storage assembly 2000 via the opening of the cover 2050 as shown in FIG. 8 and aligned with the sample transfer tube 2030 Or a compartment). A tissue sample 42 is shown disposed on the tissue holder 2200 of FIG. The vacuum supplied to the vacuum port 2060 can be kept on during the sample ablation cycle so that the vacuum pressure is always present in the hollow cutter 120. Alternatively, the vacuum supplied to the vacuum port 2060 can be turned on and off according to a predetermined schedule. Other methods by which the tissue sample 42 can be transferred from the cutter distal end 122 to the tissue holder 2200, including structures and devices that can be used, and fluid communication parameters will be apparent to those of skill in the art upon reading this disclosure. Let's go.

  Referring to FIG. 5, the manifold 2300 and the tissue holder 2200 can be aligned in rotation when the cutter 120 is retracted (indicated by arrow R). The motor 500 rotates the lead screw 510, moving the nut 520, cutter carriage 530, and cutter 120 proximally, opening the tissue opening 114 of the cannula 100. As the nut 520 moves proximally, the tab extension 522 pushes the pawl thread 2360 proximally, causing the pawl 2362 to engage the tooth 2354 and push up the tooth 2354, thereby causing the manifold gear 2350 (and manifold 2300) rotate in the direction “R” shown in FIG. Tissue holder 2200 rotates with manifold 2300 and is positioned so that the empty recess or compartment aligns with port 2057 and sample transfer tube 2030.

  In an alternative embodiment, the manifold 2300 and tissue holder 2200 can be rotated based on the rotational position of the tissue receiving opening 114 rather than using a pawl mechanism to align the angular position of the manifold 2300. For example, the cannula 100 can be rotated relative to the biopsy device, and the aperture 114 can be placed at a desired clockwise position using a thumbwheel or the like. US Pat. No. 6,602,203, the disclosure of which is incorporated herein by reference, discloses a thumbwheel for rotating a tissue receiving opening. As desired, during tissue sampling, the manifold 2300 and tissue holder 2200 may be rotated simultaneously with the opening 114 such that each tissue retention recess or section in the tissue holder 2200 coincides with a particular clock position of the opening 114. Can be configured. In another alternative embodiment, a motor 500 or another motor can be provided to rotate the tissue holder 2200 and the manifold 2300. Alternatively, the manifold 2300 can be rotated using any other suitable component, functional structure, device, or technique.

  In addition or alternatively, the tissue holder 2200 rotates a predetermined angle as the cutter 120 moves as the cutter 120 is advanced or retracted, and with each stroke of the cutter 120, the rotary manifold 2300 is attached to the manifold 2300. The supported tissue holder 2200 is repositioned so that the tissue holder 2200 is in a clockwise position to receive the tissue sample 42 that is cut during the stroke of the cutter 120. In one embodiment, a switch or lever (eg, lever 2040) can be used to select the direction of rotation of the rotary manifold as clockwise or counterclockwise. By switching the lever, the entry point of the tissue sample into the tissue storage assembly can be changed. For example, the entry point of the tissue sample can be shifted from the 12 o'clock position (directly above). In one embodiment, the lever is used to select a tissue entry point at a position of about 2 o'clock or about 10 o'clock, and the stereotaxic environment in which the biopsy device 10 can be placed in close proximity to the underside or other portion of the stereotactic table. The user using the biopsy device 10 can observe the entry of the sample into the storage assembly through the transparent cover 2010 of the tissue storage assembly 2000.

  FIG. 6 is an enlarged view of the tissue storage assembly 2000 of this example. FIG. 7 is an exploded view of the components of the tissue storage assembly 2000. FIG. 8 is a cross-sectional view of the components of the tissue storage assembly 2000. FIG. 9 is a schematic diagram of a manifold 2300 having a radially extending fin 2320 and a vacuum port 2324 for supplying a vacuum between these adjacent fins.

  With reference now to FIGS. 6-8, the tissue storage assembly 2000 of this example can include a plurality of tissue holders 2200. In FIG. 7, the tissue storage assembly includes three sample holders 2200A, 2200B, and 2200C. The tissue holders 2200A to 2200C are removably held by the manifold 2300. Each tissue holder 2200 can be removed from the biopsy device 10 by removing the cover 2010 and lifting and sliding the tissue holder 2200 from the manifold 2300 with the tissue sample 42 held by the tissue holder 2200.

  In the embodiment shown in FIGS. 6-8, each tissue holder 2200A-2200C can extend approximately 120 degrees on the outer peripheral surface of the manifold 2300. Alternatively, tissue holders 2200A-2200C may extend over any other suitable range (eg, about 90 degrees, about 180 degrees, about 360 degrees, etc.). Each tissue holder 2200A-2200C in this example is shaped or otherwise formed so that a plurality of tissue samples 42 can be spaced apart and received in sequence. In FIG. 7, each tissue holder 2200A-2200C is in the form of a flexible tissue sample strip, each tissue sample strip including a plurality of recesses 2204 for receiving a corresponding tissue sample 42.

  6-9, the manifold 2300 can include a plurality of radially extending protrusions, such as radially extending fins 2320. FIG. The tissue holders 2200A-2200C engage the fins 2320, the fins 2320 prevent circumferential movement of the holders 2200A-2200C relative to the manifold 2300, and the three tissue holders 2200A-2200C are placed in place on the manifold 2300. It can be molded or otherwise formed to maintain. When tissue holders 2200A-2200C are disposed on manifold 2300, each recess 2204 can be disposed between two adjacent fins 2320 of manifold 2300. Alternatively, the manifold 2300 can be provided with any suitable structure or functional structure that extends in a radial direction other than the fins 2320.

  Tissue sample holders 2200A-2200C can be formed from thin polymer sheet stock or using other materials, structures, and techniques. If desired, the tissue sample holders 2200A-2200C can be formed from a material that is generally radiolucent (generally X-ray transparent). In one embodiment, sample holders 2200A-2200C can be formed from about 0.015 inches (0.381 mm) or any other suitable thickness of polypropylene. Sample holders 2200A-2200C can include a radially inwardly facing surface 2203 and a radially outwardly facing surface 2205 (FIG. 8). The sample holders 2200A to 2200C can be formed by, for example, molding, vacuum forming, or compression so that the tissue receiving recess 2204 is provided on the surface 2205 facing the radially outer side of the strip. Each recess 2204 has a floor 2205, a radially outwardly extending side wall 2206, and a proximal rear wall 2208. Each recess 2204 can be positioned between two adjacent manifold fins 2320 when the sample holders 2200A-2200C are placed in the manifold 2300. Each sample holder 2200A-2200C may also include a lip 2260 extending distally.

  Alternatively, sample holders 2200A-2200C are formed to receive a tissue sample on a radially inwardly facing surface 2203 of these sample holders 2200A-2200C, or formed in any other suitable manner. be able to.

  Vacuum openings 2212, 2214 in the form of holes, slots, etc., for supplying a vacuum from manifold 2300 to recess 2204 via sample holders 2200A-2200C and to transfer tissue sample 42 from sample transfer tube 2030 to recess 2204. Can be provided on the sample holders 2200A to 2200C. For example, the vacuum opening 2214 can extend through the sidewall 2206 and the vacuum opening 2212 can extend through the floor 2205. Alternatively, any other structure in any suitable location can be used to communicate within sample holders 2200A-2200C.

  Referring now to FIGS. 8 and 9, the manifold 2300 can include fins 2320 that extend from a generally disc shaped distal end plate 2310. The distal surface of the distal end plate 2310 includes a spline structure 2314 that engages a complementary recess (not shown) in the manifold gear 2350. The end plate 2310 also includes a plurality of vacuum ports 2324 extending through the end plate 2310, each port 2324 being arranged to provide a vacuum between two adjacent fins 2320.

  A vacuum supplied from a vacuum source (eg, vacuum pump 4010 described below) to the vacuum port 2060 of the proximal cover 2050 is supplied to one of a plurality of passages 2352 that extend through the cover 2050 and through the gear 2350. Each passageway 2352 extending through the manifold gear 2350 can be aligned with the associated vacuum port 2324 of the manifold end plate 2310 when the spline structure 2314 engages the manifold gear 2350. Thus, the vacuum supplied to the port 2060 is sent through the cover 2050 to the passage of the gear 2350 and then through the vacuum port 2324 of the manifold 2300 between the two adjacent fins 2320. The direction of the air flow obtained by supplying a vacuum to the sample storage assembly is illustrated by the arrows in FIG.

  In the above-described embodiment, the tissue holder 2200 includes a plurality of sample holders 2200A to 2200C. Alternatively, the tissue holder 2200 may be a single ring, such as in the form of a continuous ring that extends 360 degrees around the manifold 2300 or a single strip that extends substantially 360 degrees around the manifold. It can be a single part. Alternatively, any other suitable structure, functional structure, or device can be used to hold the tissue sample 42.

  FIG. 10 illustrates an alternative embodiment of the tissue sample holder 2200. In FIG. 10, the sample holder 2200 includes a single strip that includes four segments 2201A-2201D. The adjacent segments 2201A to 2201D are connected to each other by a flexible hinge 2203. Each segment 2201A-2201D can have a generally arcuate shape spanning approximately 90 degrees, with a generally convex outer surface having a plurality of recesses for holding tissue.

  The holder 2200 of this example can have radiopaque or other properties and can be removed from the tissue storage assembly 2000 with the tissue samples 42 spaced and sequentially disposed on the tissue holder 2200. . The sample 42 may be placed on any suitable test instrument without removing it from the holder 2200, out of order of the samples 42 and / or without contacting the individual samples 42, Alternatively, the test and / or preparation for the test can be performed, for example, by placing it in a suitable preparation solution.

  For example, if the patient is being examined for microcalcifications, a radiograph can be taken of the sample 42 with the sample 42 placed on the tissue holder 2200. The resulting radiograph is examined for microcalcifications. If desired, a sample 42 of tissue holder 2200 exhibiting microcalcification can be removed from tissue holder 2200. The tissue holder 2200, all tissue samples 42 remaining in the tissue holder 2200, and all tissue samples 42 including microcalcifications can be both immersed in formalin solution to prepare a sample for pathology. . Alternatively, the tissue holder 2200 and the tissue sample 42 held in the tissue holder 2200 can both be immersed in saline or a suitable liquid preparation. Of course, the tissue sample 42 can be subjected to any other suitable treatment while placed in the tissue holder 2200 or otherwise.

  11 and 11A illustrate another embodiment of a tissue sample holder 2200. In FIG. 11, the sample holder 2200 includes a plurality of arms 2272 that extend radially from the hub 2270. Hub 2270 can be generally circular and sized to receive the end of manifold 2300. The arm 2272 can be sized and spaced to fit between two adjacent fins 2320 of the manifold 2300. Each arm 2272 can include a tissue receiving section 2274. The tissue receiving section 2274 may be integrally formed with the arm 2272 or may be coupled to the arm 2272 as a separate part. The tissue receiving section 2274 can be a cup or concave structure in this example, but other structures can be used. Each arm 2272 can include one or more vacuum openings for supplying vacuum from the manifold 2300 to the tissue receiving compartment 2274.

  Each arm 2272 can be connected to a hub with a hinge 2275. Each hinge 2275 can be, for example, a flexible “integral” hinge formed from a thin flexible strip of material that forms the arm 2272. Alternatively, other structures can be used. The flexible hinge 2275 of this example folds the arm 2272 radially inward so that it extends generally parallel to the longitudinal axis 2271 of the hub 2270 when the holder 2200 is positioned within the tissue storage assembly 2000. Can do. When the holder 2200 is removed from the tissue storage assembly 2000, the flexible hinge 2275 of this example causes the arms 2272 to open radially outward as shown in FIG.

  Tissue holder 2200 can include indicia (eg, letters, numbers, symbols, etc.) that are visible and / or are radiolucent. For example, this display can be used to identify individual tissue retention recesses or compartments 2274 on the tissue holder 2200. Each recess or section 2274 may have a unique number or associated symbol, such number or symbol being visible to the naked eye and / or formed or printed on a holder 2200 that is radiolucent. Is done. Thus, when the tissue holder 2200 is withdrawn from the biopsy device 10, individual tissue samples 42 can be uniquely identified on the holder 2200, both visually and / or x-rayed.

  If desired, the biopsy device 10 can include a display (not shown) to indicate the number of tissue samples 42 that were excised when the biopsy device 10 is operating. For example, biopsy device 10 or control unit 5000 can include a display, such as an LED display, that indicates the number of tissue samples 42 that have been excised and stored. In addition, the LED display can include a graphical display showing the location where each sample 42 is taken relative to a reference. For example, the display can indicate the clock position at which each sample 42 is taken relative to the first 12 o'clock position (directly above) the tissue opening 114. Alternatively, the LED display indicates the location of each compartment or recess 2274 on the tissue holder 2200, while the tissue sample 42 is positioned at a particular location in the circumferential direction of the particular compartment or recess 2274 or tissue holder 2200. It can also indicate whether or not. Alternatively, a display can be included in biopsy device 10 in any other suitable manner and location and can display any desired information.

  FIG. 12 illustrates an alternative tissue storage device 2700 that can be used to hold the tissue sample 42 so that the ends of each tissue sample are placed in series. FIG. 12A is a cross-sectional view taken along line 12A-12A. FIG. 12B is a cross-sectional view taken along the length of a portion of storage device 2700. The example storage device 2700 includes a flexible helical tissue sample holder 2710 that can be formed from a thin flexible tube, such as an extruded tube. Tissue sample holder 2710 includes three lumens 2712, 2714, 2716 extending parallel to each other along this length.

  The sample holder 2710 in this example includes a tissue sample lumen 2712, a vacuum supply lumen 2714, and lumens 2712 and lumens for receiving the tissue sample 42 such that the end of each tissue sample is placed in series. A vacuum control lumen 2716 extends along and between 2714. An elongate flexible control member 2718 is disposed within the control lumen 2716. When the elongate control member 2718 is fully inserted into the control lumen 2716, the control member 2718 serves to block a series of crossflow ports 2719 spaced apart along the length of the vacuum control lumen 2716. Fulfill. The cross flow port 2719 can be spaced along the length of the vacuum control lumen 2716. This separation is approximately equal to or slightly longer than the maximum length of the tissue sample 42 excised by the cutter 120 of the biopsy device 10. Control member 2718 can be stepped back from lumen 2716 in the direction shown to provide the vacuum in vacuum supply lumen 2714 to sample lumen 2712. Each time the control member 2718 is pulled back in steps, the pair of cross-flow ports 2719 of the vacuum control lumen 2716 is not covered and a vacuum is supplied to the sample lumen 2712. Alternatively, any other suitable structure, functional structure, device, or technique can be used to selectively provide a vacuum to the sample lumen 2712.

  In this example, the tissue sample lumen 2712 can be connected directly or indirectly to the sample transfer tube 2030. Lumen 2714 can be connected to a vacuum source (eg, vacuum control module 5000). The control member 2718 can be pulled back manually, or alternatively can be automatically pulled back by a winding mechanism (not shown) connected to the biopsy device 10.

  FIG. 13 is a schematic view of the distal portion of cannula 100. FIG. 14 is a schematic diagram of the vacuum level that can be supplied to the vacuum lumen 108 as the cutter 120 is advanced or retracted through the cutter lumen 104 relative to the tissue receiving opening 114. FIG. 13 is a diagram illustrating passages that can be provided in the internal structure of cannula 100 to provide communication between vacuum lumen 108 and cutter lumen 104. The passage 107 is generally located below the opening 114, and the passage 109 is located distal to the opening 114.

FIG. 15 is a schematic diagram of a pneumatic circuit that can be used with the biopsy device 10 of this example.
The pneumatic system can include a vacuum pump 4010, a regulator 4020, a vacuum canister / reservoir 4030, a main control valve 4060, and a saline / vacuum valve 4080.

  Since the vacuum generated by the vacuum pump 4010 is supplied to the cutter 120 and the cutter lumen 104 via the vacuum line 4012 and the tissue storage assembly 2000 without using a valve, the inside of the cutter 120 and the cutter of the cannula 100 are supplied. The vacuum supplied to the lumen 104 is always supplied during operation of the vacuum pump 4010. Alternatively, one or more valves or other functional structures or mechanisms can be provided along such a flow path. The pneumatic circuit of the vacuum lumen 108 includes two valves 4060 and 4080. The valve 4080 can include a 3 port / 2 position valve with 2 inlet ports. One inlet port can be connected to the vacuum line 4012 and the other inlet port can be connected to a saline source 4016 (or vented to the atmosphere via a filter 4018). The outlet port of the valve 4080 communicates with the inlet port of the main control valve 4060.

  The position of the valve 4080 is configured to match the position of the cutter 120. When cutter 120 is pulled back proximally (eg, so that the tissue opening opens), vacuum is supplied from valve 4080 to main control valve 4060. When the cutter 120 is advanced distally (eg, so that the tissue receiving opening 114 is closed), saline is supplied from the valve 4080 to the main control valve 4060. Alternatively, when saline is not available or needed, the valve 4080 supplies air to the main control valve 4060 through the filter 4018. The valve 4080 can be actuated in any suitable manner, including a solenoid or motor, by mechanical connection to the cutter 120 or other method. The valve 4080 can be spring loaded at a position and the position of the valve 4080 can be changed using the movement of the cutter 120 (such as movement of the cutter 120 to the distal position).

  The main control valve 4060 can include a 3 port / 3 position valve. The first inlet port can be connected to the outlet port of valve 4080. The second inlet port can be vented to the filtered atmosphere. The outlet port of valve 4060 can be connected to the proximal end of vacuum lumen 108 of cannula 100. The position of the valve 4060 can be operated by an operator of the biopsy device 10 using one or more user control interfaces such as control buttons listed in FIG. Control buttons (not shown in FIG. 10) can be placed at any convenient location on the body of the biopsy device 10, such as the handpiece 30 or other portion (eg, on the vacuum control module 5000). The valve 4060 can be actuated by a solenoid, a motor, a link to the cutter 120, or otherwise.

  Of course, the pneumatic circuit shown in FIG. 15 is merely exemplary, and any other suitable circuit may be used, including different components, component placement, and component operation.

  FIG. 16 illustrates a plurality of control states that can be used to control the biopsy device 10. Referring to FIG. 16, the “ready state” of the biopsy device 10 corresponds to the cutter 120 advanced to the distal most position and the closed tissue opening 114. In this ready state, valve 4080 supplies saline to main control valve 4060, which is in a position to seal other ports, including the outlet port in communication with vacuum lumen 108. Closing the port for the vacuum lumen 108 in the ready state can minimize the air flow through the device and the pump 4010 can easily maintain the desired vacuum level in the vacuum canister 4030.

  In this example, when the operator presses the “sample” button 170, the cutter motor is activated and the cutter 120 is pulled back proximally. When the cutter is pulled back, the position of valve 4080 is changed and vacuum is supplied to main control valve 4060. At the same time, the position of the main control valve is changed and vacuum is supplied to the vacuum lumen 108. With the tissue opening 114 open, a vacuum is drawn from the vacuum pump 4010 to the cutter 120 (via the tissue storage assembly 2000, etc.) and the cutter lumen 104 (via the cutter 120), and the vacuum lumen 108 (valve 4080). And 4060). The vacuum supplied to both the cutter lumen 104 and the vacuum lumen 108 assists in drawing tissue into the opening 114 of the cannula 100.

  Once this vacuum state has been maintained for more than 2 seconds and the tissue has been drawn into the opening 114, the cutter 120 is advanced distally (simultaneously rotated) to close the opening 114 and the tissue in the distal portion of the hollow cutter 120 Sample 42 is excised. As the cutter 120 advances distally, the cutter 120 operates contact 40 or otherwise to change the position of the valve to supply saline to the main control valve 4060. When the cutter 120 moves forward, the position of the main control valve 4060 is changed using a microprocessor to supply the filtered atmosphere to the vacuum lumen 108, and then this atmosphere is passed through the passages 107 and 109. And can be delivered to the distal surface of the ablated tissue sample 42 received in the distal portion of the hollow cutter 120. Atmosphere to the distal surface of the tissue sample 42 pushes the tissue sample 42 proximally, while the vacuum (via the tissue storage assembly 2000) supplied to the cutter 120 causes the excised tissue sample 42 to be removed. Aspirated proximally. The resulting force pushing the tissue sample 42 proximally causes the tissue sample 42 to be transferred into the tissue storage assembly 2000 via the hollow cutter 120. Of course, any other suitable structure or technique may be used to capture and transfer the tissue sample 42 to the tissue storage assembly 2000.

  In an alternative embodiment, a microprocessor is used to change the position of the main control valve 4060, first supplying saline to the vacuum lumen 108 for a predetermined time, and then changing the position of the main control valve to provide atmospheric air. Supply to vacuum lumen 108. Accordingly, a predetermined amount of saline is supplied to the distal end of the hollow cutter 120 via the passages 107, 109, so that the excised tissue sample approaches the tissue storage assembly 2000 via the hollow cutter 120. It helps to move to the side. The control system can be programmed to return to a ready state after a predetermined time (eg, 1 second or several seconds).

  The biopsy device operator opens and closes the opening 114 by reciprocating the cutter 120 for a fraction of an inch (eg, 0.2 inches (about 5 mm)) or any suitable distance under microprocessor control. As such, the “probe wash” button 172 can be pressed in a ready state (eg, after pressing the “sample” button 170 to remove the tissue). This reciprocating motion of the cutter 120 allows the tissue sample 42 to move freely through the hollow cutter 120 by removing the tissue sample 42 or otherwise leaving the tissue sample 42 absent. While the cutter 120 is reciprocating, the vacuum control valve 4060 is repositioned to supply saline to the vacuum lumen 108 via the passages 107, 109 and press the distal surface of the tissue sample 42. . After a predetermined time, the microprocessor can return the pneumatic system to a ready state.

  When an operator presses or releases the “Aspiration / Infusion” button 174 when the device is ready, a drug or tissue marker in the sampled tissue or where the tissue sample has already been removed or will be removed Can be injected. In this example, when button 174 is pressed, cutter 120 moves proximally and opening 114 opens. The position of the main control valve 4060 is changed and air is supplied to the vacuum lumen 108. Pressing the “suction / inject” button 174 stops the supply of vacuum (eg, turning off the pump 4010 or opening the regulator 4020 and venting the outlet of the pump 4010 to the atmosphere). A tissue marker (or drug) applier is fed from the hollow cutter 120 to the proximal end of the cannula 100, such as through a tissue storage assembly 2000, to deliver the marker (or drug) from the open opening 114 of the cannula 100 Can do. Once the marker or drug has been delivered, the user can return to the ready state by pressing any button that can advance the cutter 120 with the main control valve 4060 in the up position.

  The operator can press and hold the “suction / inject” button 174 to aspirate fluid near the opening 114. In this example, when the operator presses the button 174, the cutter 120 moves proximally and the opening 114 opens. When the valve 4080 supplies vacuum to the main control valve 4060 with the cutter positioned proximally, the position of the main control valve 4060 is changed and vacuum is supplied to the vacuum lumen 108. Thus, vacuum is supplied to both vacuum lumen 108 and cutter lumen 104 (in this example, vacuum is continuously supplied to cutter lumen 104 via cutter 120 while pump 4010 is operating. To be). The vacuum supplied to the cutter lumen 104 and the vacuum lumen 108 aspirates any fluid near the opening 114. When the aspirating / injecting button 174 is released, the pneumatic system is controlled to return to the ready state. Next, the cutter 120 moves forward and the opening 114 is closed. In this example, as the cutter 120 advances, the position of the main control valve 4060 is changed and the filtered atmosphere is supplied to the vacuum lumen 108. When the opening 114 is closed, the position of the main control valve 4060 is changed and all its ports are closed and ready. As with the other operational sequences disclosed herein, the operational sequences are merely exemplary, and any other operational sequence can be used in addition to or instead of the operational sequences explicitly described above.

  The length of the vacuum line 4012 from the control module 5000 containing the vacuum pump 4010 to the biopsy device 10 is controlled to accommodate the movement of the biopsy device 10 in the operating room or in a magnetic resonance imaging environment. Due to the location limitations of the module 5000, it can be relatively long, 20 feet (sometimes longer). Of course, the vacuum line 4012 can be any desired length. In this example, the vacuum line 4012 can occupy a substantial portion of the flow rate that needs to be supplied or maintained by the vacuum pump 4010 and the vacuum canister 4030 when the tissue opening 114 is open. Instead of the biopsy vacuum control unit 5000, a saline / vacuum valve 4080 and a main control valve 4060 are placed at the distal end of the vacuum line 4012 (and thus the end is connected to the biopsy device 10). Thus, a relatively small vacuum pump 4010 and a relatively small vacuum canister 4030 can be used. In certain conventional biopsy devices, the valve can be placed in a control unit that includes a vacuum pump, and this control unit can be attached to the wheel due to its weight and size. In FIG. 16, the valves 4060 and 4080 are arranged in the biopsy device 10. These valves 4060, 4080 can be placed in a disposable probe portion including cannula 100 and cutter 120 (eg, handpiece 30) and / or a non-disposable portion (eg, holster) of biopsy device 10. Such a valve arrangement allows the use of a relatively lightweight diaphragm vacuum pump 4010 with a flow rate of about 18 L / min, in contrast to conventional pump and valve configurations that require a flow rate in excess of 80 L / min. it can. Of course, any desired vacuum pump having any desired characteristics can be used.

Similarly, the vacuum canister 4030 can be relatively small in volume, less than about 300 cm ³ , as opposed to a conventional vacuum canister with a storage volume of 1200 cc or more. As a result, the vacuum control module 5000 that is relatively light and can be carried by hand can be used. The vacuum control module 5000 (FIG. 15) weighs less than 25 pounds, can be carried with one hand, and is less than about 1.5 feet (about 45.7 cm) in height, width, and length each. The dimensions can be Alternatively, vacuum canister 4030 and control module 5000 can have any other suitable volume, size, weight, or other characteristic.

  If desired, control inputs or commands can be provided directly to biopsy device 10 and / or vacuum control module 5000 using a footbed (not shown) or a remote keypad (not shown). The foot pedal and remote keypad can be moored (eg, using one or more wires extending from the foot pedal / keypad to the vacuum control module 5000). Alternatively, “wireless” communication between the foot pedal / keypad and the control module 5000 and / or the biopsy device 10 can be used. For example, using wireless “Bluetooth” communications and associated hardware and software, the vacuum control module 5000 and / or biopsy without the need for a “line of sight” to send and receive signals A radio control signal can be supplied to the device 10. Alternatively, infrared transmitters and receivers can be used to transmit and receive control signals. Other methods for establishing communication between components of the biopsy system (eg, between the foot pedal / keypad and the control module 5000), whether wired, wireless, or other means, are available to those skilled in the art. It will be clear from the disclosure.

  While preferred embodiments of the invention have been illustrated and described, it will be apparent to those skilled in the art that such embodiments are merely exemplary. Those skilled in the art will envision various modifications, variations, and substitutions without departing from the scope and concept of the appended claims. In addition, each element described in the context of the present invention can also be represented as a means for performing the function of each element.

Embodiment
(1) In the biopsy device,
(A) a cannula extending distally from the biopsy device;
(B) a tube cutter movable with respect to the cannula, the tube cutter having a proximal end and a distal end for excising tissue received in the cannula;
(C) a tissue storage assembly for receiving a tissue sample resected by the tube cutter, disposed proximal to the tube cutter;
(I) a substantially transparent cover disposed at the proximal end of the biopsy device;
(Ii) a rotating member disposed at least partially within the substantially transparent cover; and
(Iii) at least one tissue holder configured to receive a plurality of tissue samples removably held by the rotating member;
A tissue storage assembly;
Including biopsy device.
(2) In the biopsy device according to the embodiment (1),
The biopsy device, wherein the rotating member includes a manifold for guiding a vacuum to a portion of the tissue holder.
(3) In the biopsy device according to the embodiment (1),
The rotating member is a biopsy device configured to rotate by a predetermined angle when the tube cutter moves.
(4) In the biopsy device according to the embodiment (1),
The biopsy device, wherein the rotating member is selectively rotatable in either a clockwise direction or a counterclockwise direction.
(5) In the biopsy device according to the embodiment (1),
The biopsy device includes a plurality of tissue holders removably held by the rotating member;
A biopsy device, wherein each tissue holder of the plurality of tissue holders is configured to hold at least one tissue sample.

(6) In the biopsy device according to the embodiment (1),
The tissue holder includes a plurality of recesses,
Each of the plurality of recesses is a biopsy device configured to receive a resected tissue sample.
(7) In the biopsy device according to the embodiment (6),
The tissue holder has a surface facing radially inward and a surface facing radially outward,
The biopsy device, wherein the tissue holder includes a plurality of recesses defined by the radially outwardly facing surface.
(8) In the biopsy device according to the embodiment (6),
The tissue holder has a surface facing radially inward and a surface facing radially outward,
The biopsy device, wherein the tissue holder includes a plurality of recesses defined by the radially inward facing surface.
(9) In the biopsy device according to the embodiment (1),
The biopsy device, wherein the tissue holder includes at least one flexible tissue sample strip that extends at least partially around an outer periphery of the rotating member.
(10) In the biopsy device according to the embodiment (1),
At least three flexible tissue sample strips;
Including
Each of these tissue sample strips extends partially around the outer periphery of the rotating member.

(11) In the biopsy device according to the embodiment (1),
The rotating member is a biopsy device, comprising a plurality of circumferentially spaced apart radial extensions.
(12) In the biopsy device according to the embodiment (11),
The biopsy device, wherein the tissue holder is shaped to engage the radial extension of the rotating member.
(13) In the biopsy device according to the embodiment (11),
The tissue holder includes a flexible tissue sample strip;
The biopsy device, wherein the flexible tissue sample strip is shaped to provide a tissue sample recess located between adjacent radial extensions of the rotating member.
(14) In the biopsy device according to the embodiment (1),
The tissue holder includes at least one flexible tissue sample strip having a plurality of tissue sample recesses;
The biopsy device, wherein each tissue sample recess is associated with at least one vacuum opening extending through the flexible tissue sample strip.
(15) In a tissue sample storage assembly for use with a biopsy device,
(A) a removable cover;
(B) a rotary manifold having at least one vacuum passage disposed at least partially within the cover;
(C) at least one tissue sample strip disposed around an outer surface of the manifold and extending around at least a portion of the outer surface of the manifold;
Including an assembly.

(16) In the assembly according to the embodiment (15),
The assembly, wherein the removable cover is substantially transparent.
(17) In the assembly according to the embodiment (15),
The assembly further includes a plurality of tissue sample strips disposed around the outer surface of the manifold;
An assembly wherein each tissue sample strip of the plurality of tissue sample strips is configured to hold at least one tissue sample.
(18) In the assembly according to the embodiment (15),
The assembly, wherein at least a portion of the at least one tissue sample strip is radiolucent.
(19) In biopsy,
(A) providing a biopsy device having a cannula, a moving cutter, and a tissue sample holder disposed proximally of the cutter,
At least a portion of the tissue sample holder is transparent;
The tissue sample holder provides a plurality of tissue storage rooms;
Steps,
(B) inserting the cannula into the tissue mass to be sampled;
(C) moving the cutter to excise a first tissue sample from the tissue mass;
(D) transferring the first tissue sample proximally through the cutter to a first tissue storage chamber of the tissue sample holder;
(E) repositioning the tissue sample holder to yield a second empty tissue storage chamber to obtain a second tissue sample;
(F) excising a second tissue sample from the tissue mass using the cutter without removing the cannula from the tissue mass;
(G) transferring the second tissue sample proximally through the cutter to the second tissue storage chamber of the tissue sample holder;
Including biopsy methods.
(20) In the method according to embodiment (19),
The method of repositioning the tissue sample holder includes rotating the tissue sample holder to align the second tissue storage chamber with a port.

(21) In the biopsy device,
(A) a cannula extending distally from the biopsy device;
(B) a cutter movable with respect to the cannula, operable to excise tissue received within the cannula;
(C) a tissue storage assembly supported by the biopsy device for receiving a tissue sample excised by the cutter,
(I) a rotating member disposed proximally of the cannula; and
(Ii) a plurality of tissue sample holders removably held by the rotating member, each tissue sample holder being configured to receive at least one tissue sample excised by the cutter; A plurality of tissue sample holders that are removable from the rotating member while the rotating member is supported by the biopsy device;
A tissue storage assembly;
Including biopsy device.
(22) In the biopsy device according to the embodiment (21),
A vacuum source in communication with at least one of the tissue sample holders;
Further comprising a biopsy device.
(23) In the biopsy device according to the embodiment (22),
The biopsy device, wherein the vacuum source is in communication with at least one tissue sample through at least one passage of the rotating member.
(24) In the biopsy device according to the embodiment (21),
A vacuum source in communication with the lumen of the cutter through the tissue storage assembly;
Further comprising a biopsy device.
(25) In the biopsy device according to the embodiment (21),
Liquid flow path,
Further including
The biopsy device, wherein the tissue storage assembly includes a portion of the liquid flow path.

(26) In the biopsy device according to the embodiment (21),
At least one valve operable to provide selective fluid flow through at least a portion of the tissue storage assembly;
Further comprising a biopsy device.
(27) In the biopsy device according to the embodiment (21),
The cutter includes a tube cutter having a longitudinal axis and a lumen extending at least partially therethrough;
A biopsy device, wherein the cutter is at least partially disposed within the cannula.
(28) In the biopsy device according to the embodiment (27),
The cannula includes a side tissue receiving opening proximate to a distal end of the cannula;
The biopsy device, wherein the cannula further provides a fluid passage extending generally parallel to the longitudinal axis of the tube cutter and offset from the longitudinal axis.
(29) In the biopsy device according to the embodiment (28),
A vacuum source in communication with the tissue receiving opening through the fluid passage extending generally parallel to and offset from the longitudinal axis of the tube cutter;
Further comprising a biopsy device.
(30) In the biopsy device according to the embodiment (21),
The cannula includes a lateral tissue receiving opening;
The cutter is advanceable to close the lateral tissue receiving opening;
The biopsy device is operable to selectively supply atmospheric pressure to the distal end of the cutter with the cutter advanced to close the lateral tissue receiving opening.

(31) In the biopsy device according to the embodiment (21),
At least a portion of the tissue storage assembly is transparent;
A biopsy device wherein a tissue sample received by a tissue sample holder can be viewed through the transparent portion of the tissue storage assembly without removing the tissue sample holder from the rotating member.
(32) In the biopsy device according to the embodiment (21),
The biopsy device, wherein the tissue sample holder is fitted on the exterior of the rotating member.
(33) In the biopsy device according to the embodiment (21),
The biopsy device, wherein the tissue sample holder extends in a circumferential direction about a rotation axis of the rotating member.
(34) In the biopsy device according to the embodiment (21),
The biopsy device, wherein each tissue sample holder includes at least one flexible member configured to hold at least two tissue samples in a spaced relationship.
(35) In the biopsy device according to the embodiment (21),
The biopsy device, wherein each tissue sample holder includes a flexible member configured to hold at least two tissue samples in a spaced relationship.
(36) In the biopsy device according to the embodiment (21),
The biopsy device, wherein the at least one tissue sample holder includes a display for identifying individual tissue samples held by the tissue sample holder.
(37) In the biopsy device according to the embodiment (21),
The biopsy device, wherein the at least one tissue sample holder includes one or more numbers or symbols, each number or symbol associated with a tissue receiving recess of the tissue sample holder.

(38) In the biopsy device according to the embodiment (21),
(A) a cannula having a lateral tissue receiving opening;
(B) a cutter movable relative to the tissue receiving opening to excise tissue received in the tissue receiving opening;
(C) a tissue storage assembly,
(I) a manifold supported by the biopsy device proximal to the cannula; and
(Ii) a plurality of removable tissue sample holders removably held by the manifold, wherein each tissue sample holder is independently removable from the manifold;
A tissue storage assembly;
(D) a vacuum source for supplying a vacuum to the tissue sample holder through the manifold;
Including biopsy device.
(39) In the biopsy device according to the embodiment (38),
A biopsy device, wherein each removable tissue sample holder is configured to hold at least two tissue samples in a spaced relationship.
(40) In the biopsy device according to the embodiment (38),
The cannula is rotatable relative to a relatively stationary portion of the biopsy device so that a tissue sample can be excised and collected at a plurality of angular positions about the longitudinal axis of the cannula. Inspection device.
(41) In the biopsy device according to the embodiment (40),
The biopsy device is operable to store tissue samples excised from the plurality of angular positions, the samples being held in a continuous spaced relationship by the tissue sample holder.
(42) In the biopsy device according to the embodiment (41),
The biopsy device, wherein the at least one tissue sample holder includes a display for identifying individual tissue samples held by the tissue sample holder.
(43) In the biopsy device according to the embodiment (41),
At least one tissue sample holder has a plurality of tissue sample recesses;
The biopsy device, wherein the tissue sample holder includes a unique number or symbol associated with each of the plurality of tissue sample recesses.

(44) In the biopsy device,
(A) a probe having a body, a cannula extending distally from the body, a tube cutter movable relative to the cannula to excise tissue received within the cannula, and a tissue storage assembly;
(B) a reusable part operable to effect movement of the cutter;
Including
The probe and the reusable part are configured to be removably connected to each other to provide a handpiece;
A biopsy device, wherein the tissue storage assembly is rotatable relative to a relatively stationary portion of the handpiece.
(45) In the biopsy device according to the embodiment (44),
The tissue storage assembly includes a plurality of removable tissue sample holders;
A biopsy device, wherein each tissue sample holder is configured to hold at least two tissue samples in a spaced relationship.
(46) In the biopsy device according to the embodiment (44),
The tissue storage assembly includes at least one tissue sample holder;
The biopsy device, wherein the tissue sample holder is removable from the tissue storage assembly without removing the tissue storage assembly from the biopsy device.
(47) In the biopsy device according to the embodiment (44),
The tissue storage assembly includes at least two tissue sample holders;
A biopsy device, wherein each tissue sample holder is removable from the tissue storage assembly without removing the other tissue sample holder from the tissue storage assembly.
(48) In the biopsy device according to the embodiment (44),
The tissue storage assembly includes a rotating member, at least two tissue sample holders held by the rotating member,
Each tissue sample holder is a biopsy device that is removable from the rotating member without removing the rotating member from the biopsy device.

(49) In a tissue storage assembly for use with a biopsy device,
(A) a rotating member including at least one fluid passage;
(B) at least two tissue sample holders held by the rotating member;
Including
Each tissue sample holder is removable from the rotating member without removing the other tissue sample holder,
Each tissue sample holder has a vacuum opening in communication with the fluid passage of the rotating member.
(50) In the tissue storage assembly according to embodiment (49),
cover,
Further including
The tissue storage assembly, wherein the rotating member is rotatably disposed within the cover.
(51) In the tissue storage assembly according to embodiment (49),
The tissue storage assembly is configured to be removably connected to a proximal portion of a biopsy device.
(52) In the tissue storage assembly according to embodiment (49),
The tissue storage assembly, wherein the at least one tissue sample holder includes an indication for identifying an individual tissue sample held by the tissue sample holder.
(53) In the tissue storage assembly according to embodiment (49),
The tissue storage assembly, wherein the at least one tissue sample holder includes one or more numbers or symbols, each number or symbol associated with a tissue receiving portion of the tissue sample holder.

1 is a schematic view of a biopsy device having a tissue sample storage assembly according to an embodiment of the present invention. FIG. A biopsy device having a tissue sample storage assembly according to one embodiment of the present invention, wherein a portion of the biopsy device has been removed to illustrate the internal components of the biopsy device and the cutter has been retracted FIG. It is the schematic diagram seen along line 2A-2A of FIG. Having a tissue sample storage assembly according to one embodiment of the present invention, wherein a portion of the biopsy device has been removed to illustrate the internal components of the biopsy device and the cutter has been advanced across the tissue receiving port It is a schematic diagram of a biopsy apparatus. A biopsy having a tissue sample storage assembly according to an embodiment of the present invention, wherein a portion of the biopsy device has been removed to illustrate the internal components of the biopsy device and the tissue sample is placed in a tissue sample holder It is a schematic diagram of an inspection apparatus. A tissue sample storage assembly according to an embodiment of the present invention, wherein a portion of the biopsy device has been removed to illustrate the internal components of the biopsy device, showing the pull back of the cutter and the angular alignment of the tissue sample holder It is a schematic diagram of the biopsy apparatus which has. 1 is an enlarged view of an exemplary tissue storage assembly. FIG. FIG. 7 is an exploded view of components of the tissue storage assembly of FIG. 6. FIG. 7 is a cross-sectional view of components of the tissue storage assembly of FIG. FIG. 3 is a schematic view of a manifold having radially extending fins and a vacuum port for supplying a vacuum between these adjacent fins. FIG. 6 illustrates an alternative embodiment of a tissue holder. FIG. 6 illustrates another alternative embodiment of a tissue holder. FIG. 12 illustrates the tissue holder of FIG. 11 in a relatively flat structure. It is a figure which illustrates the tissue holder for hold | maintaining a tissue sample so that the edge part of each tissue sample may be arrange | positioned continuously. It is typical sectional drawing seen along line 12A-12A of FIG. FIG. 13 is a cross-sectional view taken along a portion of the length of the tissue holder shown in FIG. FIG. 3 is a schematic view of a distal portion of an exemplary cannula. FIG. 5 is a schematic view of the vacuum level supplied to the vacuum lumen as the cutter is advanced and retracted through the cutter lumen relative to the tissue receiving opening. FIG. 2 is a schematic diagram of a pneumatic control circuit that can be used with a biopsy device. It is a figure which illustrates the some control state which can be used for control of a biopsy apparatus.

Claims (1)

In the biopsy device,
(A) a cannula extending distally from the biopsy device;
(B) a cutter movable with respect to the cannula, operable to excise tissue received within the cannula;
(C) a tissue storage assembly supported by the biopsy device for receiving a tissue sample excised by the cutter,
(I) a rotating member disposed proximally of the cannula; and
(Ii) a plurality of tissue sample holders removably held by the rotating member, each tissue sample holder being configured to receive at least one tissue sample excised by the cutter; A plurality of tissue sample holders that are removable from the rotating member while the rotating member is supported by the biopsy device;
A tissue storage assembly;
Including biopsy device.

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