CN102217954B - Biopsy device and biopsy sample storing assembly - Google Patents

Biopsy device and biopsy sample storing assembly Download PDF

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Publication number
CN102217954B
CN102217954B CN 201110077184 CN201110077184A CN102217954B CN 102217954 B CN102217954 B CN 102217954B CN 201110077184 CN201110077184 CN 201110077184 CN 201110077184 A CN201110077184 A CN 201110077184A CN 102217954 B CN102217954 B CN 102217954B
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China
Prior art keywords
biopsy device
vacuum
tissue samples
retainer
sickle
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CN 201110077184
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CN102217954A (en
Inventor
J·A·希布纳
W·D·哈伯斯蒂克
K·E·霍格
T·W·V·斯皮格
M·达坎格洛
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Ethicon Endo Surgery Inc
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Ethicon Endo Surgery Inc
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Priority claimed from US11/952,405 external-priority patent/US8118755B2/en
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Abstract

The invention relates to a biopsy device and a biopsy sample storing assembly. Specifically, the biopsy device may be used to obtain and store multiple tissue samples. The device permits the tissue samples to be stored in a sequenced fashion within a generally transparent tissue storage chamber disposed at a proximal end of the biopsy device. The tissue samples can be stored on flexible tissue sample strips arranged around the circumference of a rotating vacuum manifold disposed within the chamber.

Description

Biopsy device and biopsy sample storing assembly
The application is to be that December in 2007 13 days, national applications number are the applying date: 200710186190.0, name is called the dividing an application of patent application of " biopsy device and biopsy sample storing assembly ".
The application requires the priority of the U.S. Provisional Application 60/874,792 that U.S. Provisional Application 60/869,736 that December in 2006 submitted on the 13rd and December in 2006 submitted on the 13rd, and these documents are incorporated by reference this paper.
Technical field
The present invention relates generally to biopsy device, relates in particular to a plurality of tissue samples for example to be stored in biopsy device in the part of biopsy device by interval, sequential system.The invention still further relates to the biopsy sample memory module.
Background technology
When by examination, ultrasonic, MRI, x-ray imaging etc. patient's chest or other area discovers one suspicious when organizing agglomerate, be necessary to carry out biopsy procedure and pipette one or more samples to judge whether agglomerate comprises cancerous cell from described tissue.Biopsy can be to be undertaken by the method for open or percutaneous.The medical treatment device that be used for to obtain tissue samples is known in the biopsy field, and described tissue samples is used for subsequently sampling and/or detects.For example, Ethicon Endo-Surgery, the movable detecting apparatus of a kind of commercially available commodity of Inc. MAMMOTOME by name can have been bought on market, and it is used for obtaining the breast biopsy sample.
Open biopsy can be by opening a large otch and pipetting whole agglomerate (being called the biopsy of excision formula) or most of agglomerate (be called as and cut the formula biopsy) carries out at breast.Open biopsy is the surgical procedure that can carry out with outpatient operation in hospital or surgery center, may relate to expensive and to patient's large degree damage.Compare with percutaneous biopsy, open biopsy may be with relatively high infection and the risk of bleeding, and may make mammogram almost illegible in the future by the disfigurement that open biopsy causes.In addition, the patient also makes open biopsy more not attractive for the consideration attractive in appearance of the potential danger of disfigurement.Known that some biopsy shows that the suspect tissue agglomerate is not cancer, it is inappropriate in some case that the potential negative effect of open biopsy procedure can cause described method.
Percutaneous biopsy has less invasive than open biopsy.Percutaneous biopsy can use fine needle aspiration (FNA), the biopsy of core pin or other modes to carry out.In FNA, extract fluid and cell in the suspect tissue agglomerate with a very thin pin.The pain that this method is brought is less, because hang down pain so that needn't always use local anesthetic, and may be than fine needle aspiration itself also bitterly because use local anesthetic.Yet, in some FNA program, only can obtain a small amount of cell by described program, thereby not be very effective in some situation of analyzing suspect tissue, and if the developmental stage of assessment cancer and remarkable when the discovery sample is pernicious.
In some core pin biopsy procedure, can pipette the pathological evaluation that a little tissue samples is used for tissue, comprise the progress of estimating any cancerous cell of finding.
The Ethicon Endo-Surgery that can buy on market, the movable detecting apparatus of the commodity of Inc. MAMMOTOME by name usually can be by obtaining many parts of core pin biopsy sample under vacuum-assisted in once inserting breast tissue.Particularly, the cutting organ pipe is stretched in probe to cut under vacuum-assisted prolapsus and enters tissue in side opening, regains subsequently the cutting organ pipe fully to extract sample between cutting.
For the device with relatively long cutting stroke, the extraction ratio of sample is not only rotated or the restriction of the probe required time that resets, and is subjected to the restriction of translation sickle required time.As substituting of relative " long stroke " biopsy device, " short stroke " biopsy device is documented in following commonly assigned patent application: U.S. Patent application 10/676,944, title " Biopsy Instrument with Internal Specimen Collection Mechanism ", the applying date is JIUYUE in 2003 30 days, applicant Hibner etc., US publication is 2005/0215921; With U.S. Patent application 10/732,843, denomination of invention is " Biopsy Device with Sample Tube ", the applying date is December in 2003 10 days, applicant Cicenas etc., US publication is 2004/0153003, above-mentioned both by being incorporated by reference into this paper.Sickle can cycle through and substantially equal or less times greater than the distance that strides across the side opening distance, to reduce sample time.
Following patent document discloses multiple biopsy device, at this, they all is incorporated by reference this paper: the US 6,273,862 that authorize August 14 calendar year 2001; The US 6,231,522 that authorize May 15 calendar year 2001; The US 6,228,055 that authorize May 8 calendar year 2001; The US 6,120,462 of JIUYUE in 2000 mandate on the 19th; The US 6,086,544 that on July 11st, 2000 authorized; The US 6,077,230 that on June 20th, 2000 authorized; The US 6,017,316 that on January 25th, 2000 authorized; The US 6,007,497 of December in 1999 mandate on the 28th; The US 5,980,469 that on November 9th, 1999 authorized; The US 5,964,716 that on October 12nd, 1999 authorized; The US 5,928,164 that on July 27th, 1999 authorized; The US 5,775,333 that on July 7th, 1998 authorized; The US 5,769,086 that on June 23rd, 1998 authorized; The US 5,649,547 that on July 22nd, 1997 authorized; The US 5,526,822 that on June 18th, 1996 authorized; U.S. Patent application 2003/0199753 with Hibner etc. is disclosed on October 23rd, 2003.The above discloses a kind of tissue samples box by the United States Patent (USP) 5526852 that is incorporated by reference into this paper, comprises the rotatable sample box with transmission.Other tissue samples memory modules are disclosed in following application: U.S. Patent application 10/953,395, denomination of invention is " Biopsy Device with Sample Storage ", the applying date to be JIUYUE in 2004 29 days, and US publication is 2006/0074343 patent application; With U.S. Patent application 11/198,558, the applying date is on August 8th, 2005, denomination of invention is " Biopsy Device with Replaceable Probe and Incorporating Vibration Insertion Assist and Static Vacuum Source Sample Stacking Retrieval ", US publication is 2007/0032741, and they all are incorporated by reference this paper at this.
Summary of the invention
Although made and used various biopsy devices, and having designed various tissue samples memory modules and technology, having believed that nobody made or used biopsy syste as described in the appended claims before the inventor.
More particularly, the present invention relates to following content:
(1), a kind of biopsy device, comprising:
(a) sleeve pipe that distad extends from biopsy device;
(b) can be with respect to the tubular cutter of described sleeve pipe translation, described tubular cutter has near-end and far-end, and the far-end of described sickle is used for cutting off the tissue that is received in described sleeve pipe; With
(c) be arranged on the memory module of organizing of described tubular cutter nearside, the described memory module of organizing is used to receive the tissue samples that is cut off by described tubular cutter, and the described memory module of organizing comprises:
(i) be arranged on the roughly transparent housing of the near-end of described biopsy device,
(ii) at least part of rotatable part that is arranged in described roughly transparent housing,
With
(iii) at least one tissue that is removably carried by described rotatable part keeps
Frame, the described retainer of organizing can receive a plurality of tissue samples.
(2), as (1) described biopsy device, wherein, described rotatable part comprises for vacuum being directed to the described collecting tubule of organizing the part of retainer.
(3), as (1) described biopsy device, wherein, described rotatable part can rotate a scheduled volume according to the translation of described tubular cutter.
(4), as (1) described biopsy device, wherein, described rotatable part can be selectively clockwise or be rotated counterclockwise.
(5), as (1) described biopsy device, comprise a plurality of retainers of organizing that removably carried by described rotatable part, described a plurality of each that organize retainer are configured to keep at least one tissue samples.
(6), as (1) described biopsy device, wherein, the described retainer of organizing comprises a plurality of grooves, each groove is configured to receive cut tissue samples.
(7), as (6) described biopsy device, wherein, the described retainer of organizing has radially to inner surface and surface radially outward, the wherein said retainer of organizing comprises a plurality of grooves that limited by described radially outward surface.
(8), as (6) described biopsy device, wherein, the described retainer of organizing has radially to inner surface and surface radially outward, the wherein said retainer of organizing comprises a plurality of grooves that radially limited to inner surface by described.
(9), as (1) described biopsy device, wherein, the described retainer of organizing comprises at least one flexible tissue samples band, described tissue samples band is at least part ofly around the circumferential extension of described rotatable part.
(10), as (1) described biopsy device, comprise at least three flexible tissue samples bands, every described tissue samples band portion ground is around the circumferential extension of described rotatable part.
(11), as (1) described biopsy device, wherein, described rotatable part comprises circumferentially isolated radially extension of a plurality of edges.
(12), as (11) described biopsy device, wherein, describedly organize retainer to be shaped as with the described radially extension of described rotatable part to engage.
(13), as (11) described biopsy device, wherein, the described retainer of organizing comprises flexible tissue samples band, and the tissue samples groove that can provide between the adjacent radial extension that is arranged on described rotatable part is provided wherein said flexible tissue samples band.
(14), as (1) described biopsy device, wherein, the described retainer of organizing comprises at least one flexible tissue samples band, described tissue samples band comprises a plurality of tissue samples grooves, and wherein each described tissue samples groove is associated with at least one vacuum openings that extends through described flexible tissue samples band.
(15), a kind of tissue samples memory module that uses together with biopsy device, described tissue samples memory module comprises:
(a) dismountable housing;
(b) be at least partially disposed on the interior rotatable collecting tubule of described housing, described collecting tubule has at least one vacuum passage; With
(c) at least one root tissue sample band that is arranged on described collecting tubule outer surface and extends around at least part of collecting tubule outer surface.
(16), as (15) described assembly, wherein, described detachable housing is roughly transparent.
(17), as (15) described assembly, also comprise the many root tissues sample band that arranges around the outer surface of described collecting tubule, every described tissue samples band is configured to keep at least one tissue samples.
(18), as (15) described assembly, wherein, at least a portion of described at least one root tissue sample band is radioparent.
(19), a kind of biopsy method, comprise the steps:
(a) provide a kind of biopsy device, described biopsy device has sleeve pipe, translation sickle and is arranged on the tissue samples retainer of described sickle nearside, wherein at least part of described tissue samples retainer is transparent, and described tissue samples retainer provides a plurality of locker rooms that organize;
(b) described sleeve pipe is inserted into to be taken a sample organizing in agglomerate;
(c) the described sickle of translation is to cut off the first tissue samples from described organizing agglomerate;
(d) the first tissue samples proximad is conveyed through described sickle and arrives the first locker room in described tissue samples retainer;
(e) reorientate described tissue samples retainer, to give the second locker room of clearancen, be used for collecting the second tissue samples;
(d) in the situation that do not use described sickle from organizing agglomerate to cut off the second tissue samples from organizing agglomerate to remove described sleeve pipe; With
(e) the second tissue samples proximad is conveyed through described sickle and arrives the second locker room in described tissue samples retainer.
(20), as (19) described method, wherein, described tissue samples retainer reorientate the action comprise the rotation described tissue samples retainer so that the second locker room aim at a port.
Description of drawings
Although description protects claims of the present invention as summary to particularly point out and to explicitly call for, believe by the following description of reference accompanying drawing and can better understand the present invention, wherein:
Fig. 1 is the schematic diagram of the biopsy device with tissue samples memory module of one embodiment of the present invention;
Fig. 2 is the schematic diagram of the biopsy device with tissue samples memory module of one embodiment of the present invention, and wherein the some parts of biopsy device is removed, in order to the internals of device is shown, and wherein sickle is in retracted position.
Fig. 2 A is the schematic cross-section that obtains along 2A-2A section in Fig. 2.
Fig. 3 is the schematic diagram of the biopsy device with tissue samples memory module of one embodiment of the present invention, and wherein the part of biopsy device is removed, in order to the internals of device is shown, and wherein sickle advances through organizing receiving port.
Fig. 4 is the schematic diagram of the biopsy device with tissue samples memory module of one embodiment of the present invention, and wherein the part of biopsy device is removed, in order to the internals of device is shown, and has shown that tissue samples is stored on the tissue samples retainer.
Fig. 5 is the schematic diagram of the biopsy device with tissue samples memory module of one embodiment of the present invention, wherein the part of biopsy device is removed, in order to the internals of device is shown, and the retraction of sickle and the transposition (indexing) of tissue samples retainer have been shown.
Fig. 6 provides a kind of enlarged drawing of example organization memory module.
Fig. 7 provides the exploded view of the member of organizing memory module shown in Figure 6.
Fig. 8 provides the cutaway view of the member of organizing memory module shown in Figure 6.
Fig. 9 is the schematic diagram with collecting tubule of the vacuum ports of radially extending fin and being used for transmitting vacuum between adjacent fins.
Figure 10 illustrates the another kind of alternate embodiments of organizing retainer.
Figure 11 illustrates another alternate embodiments of organizing retainer.
Figure 11 A illustrates the retainer of organizing of Figure 11 of being in relative flat configuration.
Figure 12 illustrates for the retainer of organizing with end-end retention of configuration tissue samples.
Figure 12 A is the schematic cross-section along the line 12A-12A intercepting of Figure 12.
Figure 12 B is the cutaway view that the part along the length of tissue samples retainer shown in Figure 12 obtains.
Figure 13 is the schematic diagram of the distal part of exemplary grommet.
Figure 14 be when sickle in cutter lumen with respect to organizing receiver hole to advance and when retracting, the schematic diagram of the vacuum level that provides in vacuum chamber.
Figure 15 is the schematic diagram of the pneumatic control structure that can use together with biopsy device.
Figure 16 has shown the various control state that can be used for controlling biopsy device.
The specific embodiment
Fig. 1 has shown the biopsy device 10 according to one embodiment of the present invention.The biopsy 10 of described embodiment comprises a handpiece, and general reference numeral is Reference numeral 30.Handpiece 30 can be with comfortable the holding of one hand, and can use one-handed performance.Biopsy device 10 can comprise the tissue penetration part, and for example sleeve pipe 100, and it distad stretches out from handpiece 30.Sleeve pipe 100 can comprise distal tissue puncture tip 110 and the horizontal organization receiver hole 114 that separates at nearside with tip 110.Sleeve pipe 100 can be inserted into to be taken a sample organizing in agglomerate.Then the tissue that is inhaled into hole 114 can be cut off (Fig. 2) by the far-end 122 of tubular cutter 120 that can translation in sleeve pipe 100.
The biopsy device 10 of this embodiment also comprises organizes memory module 2000, and the near-end that it can be placed on handpiece 30 is positioned at sickle 120 nearsides.Organize memory module 2000 can comprise a roughly transparent housing 2010, it is detachably connected to biopsy device 10 for example on the near-end of handpiece 30.Certainly, roughly translucent, opaque, transparent and opaque combination of housing 2010, etc., or have other suitable character arbitrarily.The near-end that housing 2010 can be detachably connected to handpiece 30 by bindiny mechanism or the feature of any appropriate, include but not limited to by be clasped, bayonet fittings, screw-type coordinate, etc.In Fig. 1, housing 2010 has the flange 2012 that the near-end of an energy and handpiece 30 releasably is clasped.
At least one in detachable housing 2010 of organizing memory module 2000 also to comprise to be arranged on that demonstrate are organized retainer 2200, and retainer 2200 releasably is carried on a rotating parts.In this embodiment, rotating parts is the form (Fig. 7) of collecting tubule (manifold) 2300, but also can use other structure or structure.Collecting tubule 2300 can be placed in housing 2010 at least in part.Tissue samples retainer 2200 can be formed or constructed into and can hold a plurality of tissue samples (totally representing with Reference numeral 42), and for example the sample order of cut device 120 cut-outs is placed on retainer 2200 at interval.
The rotatable collecting tubule 2300 of this embodiment can be automatic rotation with organizing retainer 2200, and is with regard to predetermined angular increment of transposition, as described below when for example each tissue samples 42 is cut off.In the situation that the user wishes " override (override) " automatic displacement, can provide a manual knob 2020 to allow manual rotation collecting tubule 2300 and to organize retainer 2200.Organize memory module 2000 can also comprise actuator, for example control stick 2040, and it is used for being chosen in rotatable collecting tubule 2300 and the direction of organizing retainer 2200 transpositions (clockwise or counterclockwise) in transparent housing 2010.Certainly, as other parts described here, knob 2020 and bar 2040 are only selectable, can revise as requested, substitute, replenish or omit.
Organize the operating sequence of the biopsy device of memory module 2000 to be illustrated in Fig. 2 to 5 according to the employing of one embodiment of the present invention.In Fig. 2 to 5, come display organization memory module 2000 by removing housing 2010.What Fig. 6,7 and 8 illustrated this embodiment in more detail organizes memory module 2000.
With reference to Fig. 2, wherein shown the internals that is suitable for stereospecific exemplary biopsy device 10.In Fig. 2, the sleeve pipe 100 that demonstrates is in corresponding to sleeve pipe 100 and penetrates " percussion " position in tissue by percussion assembly 150.The percussion assembly 150 of this embodiment comprises percussion crotch 152, during at percussion spring 158, percussion crotch 152 can be in the percussion state of preparing (for example pull the trigger apparatus or pull the trigger motor 156 by preparation by manual preparation) at the stored energy that is used for percussion.Alternatively, percussion assembly 150 can have arbitrarily that other suitable structures maybe can omit.
Tubular cutter 120 is placed in the cutter lumen 104 of sleeve pipe 100 in this embodiment.In Fig. 2, the sickle 120 that illustrates is in retracted position, and the distal incision tip 122 (being shown as dotted line) of sickle 120 just is in the proximal position of organizing receiver hole 114 in sleeve pipe 100.Under exemplary mode of operation, after sleeve pipe 100 percussions were entered tissue, sickle 120 was retracted into position shown in Figure 2.
With reference to Fig. 2 and Fig. 2 A, sleeve pipe 100 can also comprise the vacuum chamber 108 that is arranged under cutter lumen 104.When sleeve pipe 100 is placed into tissue, and when sickle 120 is in as shown in Figure 2 retracted position, the vacuum chamber 108 of this embodiment carries vacuum in lucky cutter lumen 104 under port or hole 114 by a plurality of paths 107 (Figure 13), with help, tissue is drawn in port one 14.Sickle 120 extends to sickle near-end 124 from distal incision tip 122.In the middle of distal incision tip 122 and near-end 124, sickle 120 is by cutter lumen 104, vacuum collecting tubule 300, saline/vacuum valve assembly 4080 and the cutter gear 410 of sleeve pipe 100.
In this embodiment, the near-end 124 of sickle 120 is connected with the far-end of tissue samples transfer tube 2030.Sample transfer tube 2030 can be a flexible pipe, by slip joint 2028 or allow sickle end 124 to move to axial with respect to pipe 2030 and other suitable connectors of rotating are connected to the near-end 124 of sickle 120.The near-end of sample transfer tube 2030 is connected on the tissue samples port 2057 of the nearside housing 2050 of organizing memory module 2000.Nearside housing 2050 surrounds the near-end of organizing memory module 2000.The housing 2010 of nearside housing 2050 and substantially transparent has formed together organizes the locker room, collecting tubule 2300 and organize retainer 2200 to be placed at least in part and organize in the locker room.Port 2057 and be used for to transmit vacuum and can form as a whole with housing 2050 to the vacuum ports 2060 of collecting tubule 2300.The instruction here is for the ease of understanding, yet sample transfer tube 2030 can be modified as required, substitutes, replenish or omit; And other various members or parts can be used to provide sickle 120 and organize fluid passage between memory module 2000.
The tissue samples 42 that cuts by sickle 120 can betransported by sickle 120, then by sample transfer tube 2030, is placed on and organizes the organizing in the locker room of memory module 2000.By in the vacuum ports 2060 of housing 2050 or other positions from vacuum source to organizing memory module 2000 that vacuum is provided.In this embodiment, entering tissue samples 42 in organizing the locker room by the port 2057 on housing 2050 is placed on and organizes on retainer 2200.
Nearside housing 2050 can also comprise and enter opening 2052, as shown in Figure 6.The tooth 2354 of collecting tubule swing pinion 2350 can be by opening 2052 and 2362 engagements of calibration ratchet.Collecting tubule swing pinion 2350 can link together by spline joint spare or other suitable connectors and collecting tubule 2300, makes thus the rotation of gear 2350 cause collecting tubule 2300 also to rotate.
In this embodiment, nearside housing 2050 comprises the flange 2056 that can be caught by the mating half section (not shown) of biopsy device 10 main bodys, longitudinal axis 2055 (Fig. 6) rotation that makes housing 2050 can winding knit memory module 2000.Bar 2040 can be used to make housing 2050 (with contact openings 2052) from first o ' clock position along rotating in a circumferential direction second o ' clock position.When bar 2040 was in as figure the position shown in (for example, Fig. 1 and 6), ratchet 2362 was by opening 2052 engaging tooths 2354.When bar 2040 is repositioned onto an other end of the seam 62 on the biopsy device shell (Fig. 1), housing 2050 and contact openings 2052 are rotated so that ratchet 2364 engaging tooths 2354.Ratchet 2362 provides collecting tubule 2300 around the indexing of axis 2055 along a direction, and ratchet 2364 provides collecting tubule 2300 around axis 2055 indexing in the opposite direction.
By changing the position of bar 2040, tissue samples 42 enters into the inlet point of organizing memory module 2000 and also changes simultaneously in this embodiment.The position of port 2057 moves in the circumferential direction when the position change of bar 2040, and transfer tube 2030 adapts to this motions simultaneously.The inlet point of the tissue samples that demonstrates in embodiment departed from for 12 o'clock (just going up) position.Bar 2040 can be used for selecting to organize inlet point at about 2 o'clock or about 10 o ' clock positions, therefore, in stereospecific environment, sample enters the operator that assembly 2000 can be used by the transparent housing 2010 of organizing memory module 2000 biopsy device 10 to be seen, the top of biopsy device 10 can be placed near the downside surface of stereotaxis workbench.
It will be appreciated that, the structure that any other is suitable or device can be used to additional or alternative bar 2040 is reorientated port 2057.For example, one or more motors or driver can be used for optionally reorientating port 2057.Alternatively, (for example, at 12 o ' clock positions etc.) can be fixed basically in the circumferential or angle position of port 2057.Similarly, ratchet 2362,2364 can change as required, substitutes, replenish or omit.
Still with reference to Fig. 2, sickle driving screw 510 is bearing on biopsy device 10, by 500 rotations of sickle motor.The rotation of screw rod 510 causes sickle frame nut 520 advance on screw rod 510 or retract according to the direction of rotation of screw rod 510.Nut 520 can be installed on sickle frame 530 or be integrally formed with it.Sickle 120 is rotatably supported on frame 530 in this embodiment, and sickle 120 can be rotated by gear 410 when sickle frame translation sickle 120 thus.The motion of nut 520 on screw rod 510 cause frame 530 and sickle 120 according to the direction of rotation of motor 500 and screw rod 510 towards nearside (retraction) or distally (advancing) axial translation.Due to sickle swing pinion 410 and driven wheel 512 engagements, can make sickle 120 around self axis rotation by gear 410.The rotation of driven wheel 512 can also provide power by motor 500.Starter 500 can make sickle 120 rotate simultaneously and translation.In Fig. 2, shown sickle frame nut 520 nearsides at it (retraction) positions, this position is corresponding to the far-end 122 of the nearside that just in time is positioned at hole 114 of sickle 120.
Still with reference to Fig. 2, ratchet 2362 is pivotably mounted on ratchet slide block 2360.In Fig. 2, the ratchet slide block 2360 that demonstrates is in its recent side position.Slide block 2360 is pushed nearside to by the lug extension 522 on sickle frame nut 520.The motion compresses sliding block spring 2361 of slide block 2360 proximads.When nut 520 and lug extension 522 distad advanced on driving screw 510, compressed sliding block spring 2361 can be used to push slide block 2360 to distally (slide block is advanced).Certainly, if necessary, spring 2361 can be omitted, change etc.
The position that shows in Fig. 2, biopsy device 10 prepares to obtain tissue samples 42.Vacuum control module 5000 (Figure 15) can be directed to vacuum vacuum chamber 108, is organized in hole 114 with attraction.With reference to Fig. 3, the farthest side position that sickle 120 has advanced to it is cutting off tissue samples 42, and the sickle 120 that illustrates extends through the hole 114 of sleeve pipe 100 and seals this hole 114.When sickle 120 advanced to position shown in Figure 3 from position shown in Figure 2, sickle 120 also rotated under the effect of sickle swing pinion 410, and swing pinion 410 is by driven wheel 512 rotations.In Fig. 3, frame 530 and sickle 120 advance by the translation of the nut 520 on screw rod 510.When nut 520 distal motion, lug extension 522 is distal motion also, pushes ratchet slide block 2360 to distally due to the expansion of spring 2361.When sickle 120 distad advanced to position shown in Figure 3 from position shown in Figure 2, ratchet 2362 was released, and the tooth 2354 of " crossing " collecting tubule gear 2350.
With reference to Fig. 4, the tissue samples 42 of the cut-out that illustrates is just breaking away from sample transfer tube 2030, is placed on and organizes on retainer 2200.In order to transmit the tissue samples 42 of cut-out to organizing memory module 2000 from sleeve pipe 100, the farthest side position that sickle 120 is in it cover organize receiver hole 114 in, vacuum in vacuum chamber 108 is cut off, and uses vacuum control valve to provide atmospheric pressure as vacuum chamber 108.Add, or alternately, can provide saline.Can use valve that the vacuum chamber 108 that saline distad is guided through sleeve pipe 100 is flow to one or more holes or path 107, described hole or path 107 provide fluid to be communicated with between the vacuum chamber 108 of cutter lumen 104 and sleeve pipe 100 far-ends.Brine stream and/or atmospheric pressure provide the power of pointing to nearside on the tissue samples of cut device 120 cut-outs, it provides " thrust " of pointing to nearside to the cut tissue samples that is positioned at sickle 120 distal part.
In addition, can transmit vacuum to vacuum ports 2060 by using-system storage vacuum source.The vacuum that provides at port 2060 is transmitted through by sample transfer tube 2030 organizes memory module 2000 to arrive sicklies 120.Therefore, applied " pulling force " that points to nearside on the cut tissue samples of vacuum in sickle 120 that port 2060 provides.Being used for transmitting tissue samples 42 in the combination of " thrust " that is cut off the sensing nearside on tissue samples and " pulling force " passes sickle 120 (near-end 124 from the far-end 122 of sickle to sickle), passes sample transfer tube 2030 (it can extend through the opening on housing 2050 as illustrated in fig. 8), enters and organize memory module 2000 and be placed on the part of aiming at sample transfer tube 2030 (for example groove or chamber) of organizing retainer 2200.Display organization sample 42 is placed on and organizes on retainer 2200 in Fig. 4.The vacuum that provides to vacuum ports 2060 can keep " connection " within the whole sample cutting cycle, thereby has vacuum pressure in the inside of hollow cutter 120 always.Alternatively, the vacuum that is provided to vacuum ports 2060 can switch on and off according to preset program circulation.Consider the instruction here, those of ordinary skills can expect that other can be transported to tissue samples 42 mode of organizing retainer 2200 from sickle far-end 122, comprise operable construction and device and fluid Transfer Parameters.
With reference to Fig. 5, collecting tubule 2300 and organize retainer 2200 can be rotated displacement (R points out as the arrow labelling) during sickle 120 is retracted.Motor 500 provides power for the rotation of driving screw 510, in order to make nut 520, sickle frame 530 and sickle 120 proximad translations, organizes hole 114 thereby open on sleeve pipe 100.When nut 520 proximads are advanced, lug extension 522 proximal direction promote ratchet slide block 2360, cause ratchet 2362 engaging tooths 2354 tooth pushing 2354 that also " makes progress ", cause collecting tubule gear 2350 (with collecting tubule 2300) to rotate along direction shown in Figure 5 " R ".Organize retainer 2200 to rotate together with collecting tubule 2300, and be positioned to make its empty groove or chamber to aim at port 2057 and sample transfer tube 2030.
In a kind of alternate embodiments, not to make collecting tubule 2300 transpositions with detent mechanism, but make collecting tubule 2300 and organize retainer 2200 to be rotated according to the turned position of organizing receiver hole 114.For example sleeve pipe 100 can rotate with respect to biopsy device, hole 114 is positioned at required clock position, for example uses finger wheel.United States Patent (USP) 6,602,203 (being incorporated by reference this paper at this) disclose and have been used for the finger wheel that receiver hole is organized in rotation.If necessary, therefore collecting tubule 2300 and organize retainer 2200 can be arranged to hole 114 rotations is organizing each on retainer 2200 to organize retaining groove or chamber corresponding to the specific o ' clock position in hole during sample of tissue 114.In another kind of alternate embodiments, can use motor 500 or independent motor rotation to organize retainer 2200 and collecting tubule 2300.Optionally, collecting tubule 2300 can rotate with any other suitable member, parts, device or technology.
In sickle 120 translations, for example organize retainer 2200 to replenish when sickle 120 advances or retracts or alternatively rotate a scheduled volume, thus for each stroke of sickle 120, rotatable collecting tubule 2300 is reorientated to be bearing in and is organized retainer 2200 on collecting tubule 2300, make and organize retainer 2200 " be set in required clock position ", in order to be received in cut tissue samples 42 in these sickle 120 strokes.In one embodiment, switch or bar (for example, bar 2040) can be used to allow to select the direction of rotation of rotatable collecting tubule for clockwise or counterclockwise.By carriage release lever, tissue samples enters the inlet point of organizing memory module and also can change.For example, the inlet point of tissue samples can depart from 12 o ' clock positions (just going up).In one embodiment, bar can be used to select to organize inlet point at about 2 o'clock or about 10 o ' clock positions, thereby sample enters the operator that assembly can be used by the transparent housing 2010 of organizing memory module 2000 biopsy device 10 and sees in stereospecific environment, in described stereotaxis environment, biopsy device 10 can be placed on the downside surface of stereotaxis workbench or other places.
Fig. 6 provides this embodiment to organize the enlarged diagram of memory module 2000.Fig. 7 provides the exploded view of the member of organizing memory module 2000.Fig. 8 provides the sectional view of the member of organizing memory module 2000.Fig. 9 is the schematic diagram with collecting tubule 2300 of the vacuum ports 2324 of radially extending fin 2320 and being used for transmitting vacuum between adjacent fins.
With reference to Fig. 6 to 8, the memory module 2000 of organizing in this embodiment can comprise a plurality of retainers 2200 of organizing.In Fig. 7, organize memory module to comprise three sample retainers, be marked as 2200A, 2200B and 2200C.Organize retainer 2200A-C removably to be carried by collecting tubule 2300.Each organize retainer 2200 can in the situation that tissue samples 42 be held in place thereon by removing housing 2010 and rising or slip off retainer 2200 and remove from biopsy device 10 from collecting tubule 2300.
In the embodiment shown in Fig. 6 to 8, each organizes retainer 2200A-C can extend around the girth of collecting tubule 2300 about 120 degree.Alternatively, organize retainer 2200A-C can extend to any other suitable scope (for example, about 90 degree, about 180 degree, about 360 degree etc.).Each of this embodiment organized retainer 2200A-C to be formed or formed with the interval, mode order and receive and hold a plurality of tissue samples 42.In Fig. 7, each organizes retainer 2200A-C is the form of flexible tissue samples band, and each tissue samples band comprises a plurality of grooves 2204, and each groove 2204 is used for receiving tissue samples 42 separately.
With reference to Fig. 6 to 9, collecting tubule 2300 can comprise a plurality of projections of radially extending, the fin 2320 that for example radially extends.Organize retainer 2200A-C to be formed or otherwise form with fin 2320 and engage, make fin 2320 prevent that retainer 2200A-C from making circumferential movement with respect to collecting tubule 2300, and fin 2320 keep three to organize retainer 2200A-C suitable position on collecting tubule 2300.When organizing retainer 2200A-C to be positioned on collecting tubule 2300, each groove 2204 can be placed between a pair of adjacent fins 2320 of collecting tubule 2300.Alternatively, also can provide radially extending or structure or the parts of any appropriate of other modes except fin 2320 by collecting tubule 2300.
Tissue samples retainer 2200A-C can be formed by thin polymer plate or use other materials, structure and method to form.If necessary, tissue samples retainer 2200A-C can use roughly that radioparent (roughly can see through X ray) material forms.In one embodiment, sample retainer 2200A-C can by thickness be approximately 0.015 inch or arbitrarily the polypropylene of other suitable thickness form.Sample retainer 2200A-C can have radially inner surperficial 2203 and radially outer surperficial 2205 (Fig. 8).Sample retainer 2200A-C can be formed (for example by molded, vacuum forming or punching press etc.) for have tissue reception groove 2204 on the radially outward surface 2205 of band, and each groove 2204 has substrate 2205, sidewall 2206 and nearside rear wall 2208 extend radially outwardly.When sample retainer 2200A-C was positioned on collecting tubule 2300, each groove 2204 can be placed between a pair of adjacent fins 2320 of collecting tubule.Each sample retainer 2200A-C can also comprise the antelabium 2260 that distad extends.
Alternatively, sample retainer 2200A-C can be shaped as sample retainer 2200A-C radially on inner surface 2203 or with other suitable mode tissue receiving sample.
Vacuum openings 2212,2214 (being for example the form of hole or groove) can be arranged in sample retainer 2200A-C, in order to vacuum is transmitted by sample retainer 2200A-C from collecting tubule 2300, thereby tissue samples 42 is sent to groove 2204 from sample transfer tube 2030.For example, vacuum openings 2214 can extend through sidewall 2206, and vacuum openings 2212 can extend through substrate 2205.Alternatively, any other structures in any suitable location can be used to allow fluid to transmit by sample retainer 2200A-C.
With reference to Fig. 8 and 9, collecting tubule 2300 can comprise the fin 2320 that extends from discoidal distal plate 2310 roughly.The distal face of end plate 2310 comprises spline parts 2314, is used for coordinating with complementary groove (not shown) on collecting tubule gear 2350.End plate 2310 also comprises a plurality of vacuum ports 2324 that extend through end plate 2310, and each port 2324 is placed with for guide vacuum between adjacent a pair of fin 2320.
The vacuum that the vacuum ports 2060 of nearside housing 2050 is provided and is sent to by vacuum source (for example, from vacuum pump as described below 4010) is conducted through housing 2050, arrives in a plurality of paths 2352 that extend through gear 2350.When spline parts 2314 coordinate with collecting tubule gear 2350, each run through path 2352 that collecting tubule gear 2350 extends can to collecting tubule end plate 2310 on relevant vacuum ports 2324 alignings.Therefore, be conducted through housing 2050 path in arriving gears 2350 in the vacuum that port 2060 provides, then by the vacuum ports 2324 in collecting tubule 2300, be directed between a pair of adjacent fin 2320.The direction of the air-flow that the sample storage vacuum source provides illustrates with arrow in Fig. 8.
In the above-described embodiment, organize retainer 2200 to comprise a plurality of sample retainer 2200A-C.Alternatively, organize retainer 2200 can comprise an independent part, the form of the continuous loop of the 360 deg that for example extends around collecting tubule 2300, or the form of basically extending the single band of 360 deg around collecting tubule.Alternatively, other suitable structures, parts or device can be used to keep tissue samples 42 arbitrarily.
Figure 10 illustrates a kind of alternate embodiments of tissue samples retainer 2200.In Figure 10, sample retainer 2200 comprises single band, and described band comprises four section 2201A-D, and the adjacent a pair of section of section 2201A-D links together by flexible hanger 2203.Each section 2201A-D can have roughly arc around about 90 degree, and wherein roughly the outer surface of convex has a plurality of grooves, and each groove be used for to keep tissue samples.
In the situation that tissue samples 42 organizes on retainer 2200 with compartment of terrain, arranged sequentially remaining on, this embodiment radioparent or have the retainer 2200 of other character can be by from organizing memory module 2000 to remove.Sample 42 need not be removed from retainer 2200, do not upset the order of sample 42 yet and/or do not contact single sample 42, sample 42 just can be detected and/or be ready to detect, and for example prepares in fluid by sample 42 and retainer 2200 are placed on any suitable checkout equipment or are placed on suitable detection.
For example, if check patient's Microcalcification, be placed at sample 42 and just can carry out the radiography of sample on sample 42 when organizing on retainer 2200.The sample actinogram that obtains is used for checking Microcalcification.If necessary, organizing those samples 42 that show Microcalcification on retainer 2200 to remove from organizing retainer 2200.Organize retainer 2200, any tissue samples 42 and any tissue samples 42 that comprises Microcalcification of organizing on retainer 2200 of remaining on to be immersed together preparation pathology sample in formalin liquid.Alternatively, organize retainer 2200 with remain on the tissue samples 42 organized on retainer 2200 can together be dipped in saline or suitable liquid preparation.Certainly, tissue samples 42 can still organizing on retainer 2200 or not condition under use other suitable step process arbitrarily.
Figure 11 and 11A illustrate the another kind of embodiment of tissue samples retainer 2200.In Figure 11, sample retainer 2200 comprises from the radially-protruding a plurality of arms 2272 of hub 2270.Drawing a bow to the full 2270 can have substantial cylindrical, and its size makes on its end that can be assemblied in collecting tubule 2300.The size of arm 2272 and interval can be assemblied between the adjacent fins 2320 of collecting tubule 2300.Each arm 2272 can comprise organizes receiving chamber 2274, organize receiving chamber 2274 can be formed on arm 2272 from it, or be connected to independent part on arm 2272.Although organize in this embodiment receiving chamber 2274 to use cup-shaped or structure groove type, other structures also can use.Each arm 2272 can comprise one or more vacuum openings, is used for vacuum is delivered to from collecting tubule 2300 organizing receiving chamber 2274.
Each arm 2272 can be connected to by hinge 2275 and draw a bow to the full.Each hinge 2275 can be flexible " activity " hinge, and it is for example formed by the thin flexible belt of the material that forms arm 2272.Alternatively, other structures can be used.When retainer 2200 is placed on when organizing on memory module 2000, the flexible hanger 2275 in this embodiment allows arm 2272 radially inwardly folding, and draws a bow to the full 2270 longitudinal axis 2271 almost parallel ground extensions.By when organizing memory module 2000 to remove, the flexible hanger 2275 in this embodiment allows that arm 2272 radially outward is folded into flat configuration, for example shown in Figure 11 A when retainer 2200.
Organize retainer 2200 can comprise visible and/or radiopaque labelling (for example letter, numeral, symbol etc.).For example, labelling can be used to be identified in each that organize on retainer 2200 independent organize retaining groove or chamber 2274.Each groove or chamber 2274 can have a relative unique numeral or symbol, and wherein numeral or symbol are that to form or be printed on retainer 2200 naked eyes visible and/or radiopaque.Therefore, when organizing retainer 2200 to retract from biopsy device 10, independent tissue samples 42 can on retainer 2200 by visual and/or identified uniquely under X ray.
If necessary, biopsy device 10 can comprise the display device (not shown), is used for identifying the numeral at the cut sample 42 of biopsy device 10 operating process.For example, biopsy device 10 or control unit 5000 can comprise display device, for example light emitting diode (LED) display device, and it identifies the numeral of the tissue samples 42 that cuts and store.In addition, light emitting display device can comprise pictorialization device, is used for the position that each sample 42 of sign is extracted with respect to the reference position.For example, display device can identify position that each sample 42 is extracted with respect to organize hole 114 initial 12 o'clock (just going up) position " o'clock " position.Alternatively, light emitting display device can be identified at each chamber of organizing on retainer 2200 or the position of groove 2274, and wherein whether light emitting display device sign tissue samples 42 has been stored in given chamber or groove 2274, or around the ad-hoc location of organizing retainer 2200 circumference.Alternatively, display device can be combined in any other suitable positions in any other suitable modes with biopsy device 10, and can show the information of any needs.
Figure 12 shows a kind of alternative memory module 2700 of organizing, and it can be used to hold-hold retention of configuration sample 42.Figure 12 A is the cutaway view that 12A-12A along the line obtains.Figure 12 B is the profile that the segment length along part memory module 2700 obtains.That memory module 2700 in this embodiment comprises is flexible, the tissue samples retainer 2710 of coiling, its can by the flexible pipe of thin-walled for example extruded tube form.Tissue samples retainer 2710 comprises three chambeies 2712,2714,2716, and they extend side by side mutually along the length of the tissue samples retainer 2710 of coiling.
The sample retainer 2710 of this embodiment comprises for the tissue samples chamber 2712 of end-end order tissue receiving sample 42, vacuum supply chamber 2714 and the vacuum control chamber 2716 that mutually extend side by side between chamber 2712 and chamber 2714 and with them.Flexible elongated control member 2718 is placed in control chamber 2716.When elongated control member 2718 was inserted in control chamber 2716 fully, control member 2718 was used for stopping up a series of cross-current port 2719, and these ports 2719 are arranged 2716 length compartment of terrain along the vacuum control chamber.Cross-current port 2719 can be along the vacuum control chamber placement that keeps at a certain distance away of 2716 length, described distance is substantially equal to or is a bit larger tham the greatest length of the tissue samples 42 that is cut off by the sickle 120 of biopsy device 10.Control member 2718 can be from the chamber 2716 be retracted by the direction that shows gradually, to allow being vacuum transferred into sample chamber 2712 in vacuum supply chamber 2714.When each control member 2718 was retracted gradually, the pair of cross flow port 2719 in vacuum control chamber 2716 was exposed, thereby provided vacuum for sample chamber 2712.Alternatively, can use any other suitable structures, parts, device or method to transmit selectively vacuum to sample chamber 2712.
In this embodiment, tissue samples chamber 2712 can directly or indirectly be connected to sample transfer tube 2030.Chamber 2714 can be connected to vacuum source (for example, vacuum control module 5000).Control member 2718 can be by manual refraction, or alternatively, can automatically be retracted by the winding mechanism (not shown) that links with biopsy device 10.
Figure 13 provides the schematic diagram of the distal part of sleeve pipe 100, Figure 14 provide when sickle 120 in cutter lumen 104 with respect to organizing receiver hole 114 to advance and when retracting, the schematic diagram of the vacuum level that provides in vacuum chamber 108.Figure 13 shows and can be arranged on the path that is used for providing the fluid connection in sleeve pipe 100 internal structures between vacuum chamber 108 and cutter lumen 104.Path 107 is arranged under hole 114 usually, and path 109 is arranged on the distally in hole 114.
Figure 15 is the schematic diagram that can be used for the pneumatic structure of this embodiment biopsy device 10.Described pneumatic system can comprise vacuum pump 4010, actuator 4020, vacuum tank/container 4030, main control valve 4060 and saline/vacuum valve 4080.
The vacuum that is provided by vacuum pump 4010 can not use valve and be conducted through vacuum tube 4012, by organizing memory module 2000, arriving sickle 120 and cutter lumen 104, when vacuum pump 4010 work, the vacuum that is provided to the cutter lumen 104 of sickle 120 inside and sleeve pipe 100 is in the state of " connection " always.Alternatively, one or more valves or other parts or mechanism can be set along such fluid passage.The pneumatic circuit that is used for vacuum chamber 108 comprises two valves 4060,4080.Valve 4080 can comprise two-position three-way valve, and it has two input ports.An input port can be connected to vacuum tube 4012, and another input port can be connected to saline source 4016 (or alternatively by filter 4018 and atmospheric pressure ventilation).The output port of valve 4080 is connected with the entry port of main valve 4060.
The position of valve 4080 is according to the position configuration of sickle 120.When sickle 120 proximads were retracted (for example, causing organizing hole 114 to be opened), valve 4080 transmitted vacuum to main control valve 4060.When sickle 120 distad advanced (for example, causing organizing receiver hole 114 to be closed), valve 4080 transmitted saline to main control valve 4060.Alternatively, if saline is unavailable, or do not need, valve 4080 transmits atmosphere to main control valve 4060 by filter 4018.Valve 4080 can use the method for any appropriate to open, and comprises using solenoid, motor, mechanical linkage or the unlatching of other method by being connected to sickle 120.Valve 4080 can be loaded into a position by elasticity, and the motion of sickle 120 (for example distad motion of position of sickle 120) can be used for changing the position of valve 4080.
Main control valve 4060 can comprise three-position three-way valve.An input port can be connected to the output port of valve 4080.Second input port can be ventilated with the atmosphere that filters.The output port of valve 4060 can be connected to the near-end of the vacuum chamber 108 of sleeve pipe 100.The position of valve 4060 can be controlled with one or more user control interface by the operator of biopsy device 10, for example is listed in the control knob on Figure 16.Control knob (showing on equipment 10) can be positioned at any position easily on biopsy device 10 main bodys, for example comprises on handpiece 30, or other positions (for example, on vacuum control module 5000).Valve 4060 can be by solenoid, motor, open by the connecting rod that is connected to sickle 120 or additive method.
Certainly, the pneumatic circuit that Figure 15 shows is only illustrative, and other suitable loops arbitrarily comprise that the layout of different component, member and the operation of member also can use.
Figure 16 has shown the various control state that can be used for controlling biopsy device 10.With reference to Figure 16 and with reference to Fig. 8, " ready state " of biopsy device 10 advanced to its farthest side position and organizes hole 114 to be closed corresponding to sickle 120.In ready state, valve 4080 transmits saline to main control valve 4060, and main control valve is in the position of its other ports of sealing (closing), comprises the output port that is communicated with vacuum chamber 108.By being closed to the port in the chamber 108 of side when the ready state, the air-flow by this device can be minimized, and can allow like this pump 4010 more easily to keep required vacuum level in vacuum tank 4030.
When the operator depressed " sample " button 170, the sickle motor was activated in this embodiment, caused sickle 120 proximads to be retracted.When sickle was retracted, valve 4080 changed the position to transmit vacuum to main control valve 4060.Simultaneously, main control valve changes the position, to transmit vacuum to vacuum chamber 108.Under the condition of organizing hole 114 to open, be used to sickle 120 (for example by organizing memory module 2000) and cutter lumen 104 (by sickle 120) and vacuum chamber 108 (by valve 4080 and 4060) from the vacuum of vacuum pump 4010.The vacuum that is applied to cutter lumen 104 and vacuum chamber 108 helps the tissue prolapsus to enter the hole 114 of sleeve pipe 100.
Kept this vacuum state one second or the longer time with guarantee to organize prolapse enter hole 114 after, sickle 120 distad advances (and rotation simultaneously) closing closed pore 114, and is breaking at the tissue samples 42 of the distal part of hollow cutter 120.When sickle 120 distad advanced, sickle 120 can contact or open valve 4080 by other means, transmitted saline to main control valve 4060 to change valve position.And, when sickle 120 advances, can use position that microprocessor changes main control valve 4060 to transmit the atmosphere that filters in vacuum chamber 108, then be transmitted the distal face of the tissue samples 42 that arrives the cut-out that is positioned at hollow cutter 120 distal part by path 107,109 again.The thrust of the proximad that acts on tissue samples 42 is provided at the atmosphere of tissue samples distal face, and the vacuum (by organizing memory module 2000) in sickle 120 provides the pulling force of the proximad on the tissue samples 42 that acts on cut-out simultaneously.The power of final proximad is carried tissue samples 42 to enter by hollow cutter 120 and is organized memory module 2000 on tissue samples 42.Certainly, other suitable structures or method can be used for capture tissue sample 42 and transmit it to organizing memory module 2000 arbitrarily.
In a kind of alternate embodiments, can use the position of microprocessor change main control valve 4060 at first to transmit saline in vacuum chamber 108 at predetermined amount of time, atmosphere is transmitted in chamber 108 in the position that then changes valve.Thus, the saline of fixed amount can be passed to by path 107,109 far-end of hollow cutter 120, and memory module 2000 is organized in 120 arrival thereby the tissue samples proximad that help is cut off moves through hollow cutter.Control system can be programmed, and is returned to ready state after predetermined amount of time (a second or many seconds).
When being in ready state (for example, after operating " sample " button 170 cut-out tissues), the biopsy device operator can depress " cleaning probe " button 172, for generation of a micro processor controls, make sickle 120 slightly move back and forth to open and close hole 114 part inch (for example 0.2 inch) or any appropriate amplitudes.This reciprocating motion of sickle 120 is moving tissue sample 42 or otherwise discharge sample 42 effectively, thereby makes sample 42 can freely move through hollow cutter 120.In the reciprocating while of sickle 120, vacuum control valve 4060 can be relocated to transmit saline to vacuum chamber 108 with by path 107,109, provides thrust with the distal face to tissue samples 42.After the predetermined time section, microprocessor can be replied pneumatic system to ready state.
When device was in ready state, the operator can depress and discharge " suction/insert " button 174, with medicine tissue mark is inserted in sampled tissue or tissue samples or the position that will be gathered.When button 174 was depressed, sickle 120 proximad translations were to open hole 114 in this example.The position of main control valve 4060 is changed to transmit atmosphere to vacuum chamber 108.Depress " suction/insert " button 174 and also cut off vacuum (for example make pump 4010 outlets lead to atmosphere by closing pump 4010 or opening actuator 4020, etc.).Tissue mark's (or medicine) applicator can be placed to by hollow cutter 120 near-end of sleeve pipe 100, for example by organizing memory module 2000 or other modes, labelling (or medicine) is employed by the hole of opening 114 on sleeve pipe 100 subsequently.After labelling or medicine be employed, the user can press any button, its can be under the state that main control valve 4060 is located up cutter advance 120, be returned to ready state.
The operator can depress and keep " suction/insertion " button 174 with near the fluid of sucking-off hole 114.When operator's press push button 174, sickle 120 is shifted to nearside to open hole 114 in this embodiment.When sickle was in proximal position, valve 4080 transmitted vacuum to main control valve 4060, and main control valve 4060 is positioned to transmit vacuum to vacuum chamber 108.Therefore, vacuum is used to chamber 108 and 104 two intracavity of cutter lumen (because in this embodiment when pump 4010 is worked, vacuum is provided to chamber 104 by sickle 120 continuously).Be provided near any liquid of vacuum holes 114 in chamber 104 and chamber 108.Suction/when inserting button 174, the control pneumatic system is returned to ready state when discharging.Cutter advance 120 is to close closed pore 114.When sickle 120 was advanced, the atmosphere that main control valve 4060 is oriented to filter was sent to vacuum chamber 108 in this embodiment.In case hole 114 is closed, main control valve 4060 is oriented to close its all of the port to be in ready state.As other operating sequence described herein, the aforesaid operations order is only illustrative, and other suitable operating sequences can be used to replenish or substitute the operating sequence of clearly describing here arbitrarily.
In order to adapt to the movement of biopsy device 10 in operating room, or due to the limited location system of control module 5000 in the nuclear magnetic resonance environment, can relatively grow (can reach 20 feet or sometimes longer) from the control module 5000 of holding vacuum pump 4010 to the length of the vacuum tube 4012 of biopsy device 10.Certainly, vacuum tube 4012 can be the length that needs arbitrarily.In this embodiment, vacuum tube 4012 can be used for when organizing hole 114 to open sizable part of the fluid volume that need to supply with or keep by vacuum pump 4010 and vacuum tank 4030.Saline/vacuum valve 4080 and main control valve 4060 are placed on the far-end (with the corresponding end of biopsy device 10) of vacuum tube 4012 rather than are placed in biopsy vacuum control unit 5000, this means and to use less vacuum pump 4010 and less vacuum tank 4030.In some traditional biopsy device, valve can be placed in the control unit that comprises vacuum pump, and because weight and the size of control unit can be equipped with wheel for it.The valve 4060,4080 that demonstrates in Figure 16 is placed in biopsy device 10.Valve 4060,4080 can be placed in the disposable probe segment that comprises sleeve pipe 100 and sickle 120 (for example handpiece 30) and/or be arranged in the non-once part (for example frame) of this biopsy device 10.The conventional pump that surpasses the flow velocity of 80 liter/mins of clocks with needs is compared with the valve layout, and it is the vacuum diaphragm pump 4010 of about 18 liter/mins of clocks that such valve setting can allow the relatively low flow velocity of operating weight.Certainly, the vacuum pump that has an any desired of any desired character can be used.
Similarly, compare with the traditional vacuum tank with 1200 cubic centimetres or above volumetric storage capacity, vacuum tank 4030 can less, has the volume less than about 300 cubic centimetres.Therefore, can use a relative lightweight, vacuum control module 5000.The weight of vacuum control module 5000 (Figure 15) can be carried by one hand less than 25 pounds, can have all height, width and length less than about 1.5 feet.Alternatively, vacuum tank 4030 and control module 5000 can have other suitable capacity, size, weight and other character arbitrarily.
If necessary, can provide direct control inputs or instruction to biopsy device 10 and/or to vacuum control module 5000 with foot switch (not shown) or remote keypad (not shown).Foot switch and remote keypad can be wired connection (for example, have one or more electric wire that extends to vacuum control module 5000 from foot switch/keyboard, etc.).Alternatively, can use " wireless " communication between foot switch/keyboard and vacuum control module 5000 and/or biopsy device 10.For example, wireless " bluetooth " communication and related hardware and software can be utilized for vacuum control module 5000 and/or biopsy device 10 provides radio control signal, and no longer need " visible line " for the signal sending and receiving.Alternatively, infrared transmitter and receptor can be used for transmitting and receiving control signal.In view of the instruction here, those of ordinary skills can be clear, uses additive method communication, wired, wireless or other modes in (for example between foot switch/keyboard and control module 5000) between the biopsy syste member.
Although the preferred embodiments of the present invention are shown and explanation here, obviously these embodiment are only illustrational for a person skilled in the art.The spirit and scope that do not depart from for a person skilled in the art accessory claim can produce a lot of variations, change and displacement.In addition, the element that relates to each description of invention can be replaced with existing means with this element function of execution.

Claims (11)

1. biopsy device, it has the tissue samples memory module for biopsy device, and described biopsy device comprises:
(a) sleeve pipe, it distad extends from described biopsy device;
(b) tubular cutter, it can be with respect to described sleeve pipe translation, and described tubular cutter has near-end and far-end, and described far-end can cut off the tissue that described sleeve pipe receives; And
(c) tissue samples memory module, it comprises:
(i) rotating parts,
(ii) organize retainer by what described rotating parts removably carried, wherein organize retainer to comprise a plurality of grooves, each groove can receive cut tissue samples, and
(iii) housing, wherein said rotating parts and the described retainer of organizing are at least partially disposed in described housing.
2. biopsy device according to claim 1, comprise the nearside housing, and wherein said nearside housing comprises sample port and vacuum ports.
3. biopsy device according to claim 2, wherein said sample port can be communicated with described cover pipe fluid, and described sample port can be communicated with at least one fluid in described a plurality of grooves.
4. biopsy device according to claim 3, wherein said sleeve pipe has central axial line and described sample port has central axial line, and the central axial line of wherein said sleeve pipe is coaxial with the central axial line of described sample port.
5. biopsy device according to claim 2, wherein said vacuum ports can be communicated with the vacuum source fluid, and described vacuum ports can be communicated with at least one fluid in described groove.
6. biopsy device according to claim 1, wherein said groove also comprises a plurality of vacuum openings.
7. biopsy device according to claim 6, wherein said a plurality of vacuum openings are a plurality of holes.
8. biopsy device according to claim 1, comprise the rotating parts gear that can be attached to described rotating parts, and wherein said rotating parts gear couplings is to motor.
9. biopsy device according to claim 8, wherein said rotating parts gear comprises the connector with key.
10. biopsy device according to claim 1, the wherein said retainer of organizing also comprises antelabium.
11. biopsy device according to claim 1, wherein said tissue samples memory module is connected to described biopsy device detachably.
CN 201110077184 2006-12-13 2007-12-13 Biopsy device and biopsy sample storing assembly Active CN102217954B (en)

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CN102217954A (en) 2011-10-19
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