US20170367687A1 - Biopsy device with integral vacuum assist and tissue sample and fluid capturing canister - Google Patents
Biopsy device with integral vacuum assist and tissue sample and fluid capturing canister Download PDFInfo
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- US20170367687A1 US20170367687A1 US15/674,139 US201715674139A US2017367687A1 US 20170367687 A1 US20170367687 A1 US 20170367687A1 US 201715674139 A US201715674139 A US 201715674139A US 2017367687 A1 US2017367687 A1 US 2017367687A1
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- tissue sample
- sample holder
- cutter
- biopsy
- tissue
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B10/02—Instruments for taking cell samples or for biopsy
- A61B10/0233—Pointed or sharp biopsy instruments
- A61B10/0266—Pointed or sharp biopsy instruments means for severing sample
- A61B10/0275—Pointed or sharp biopsy instruments means for severing sample with sample notch, e.g. on the side of inner stylet
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B10/02—Instruments for taking cell samples or for biopsy
- A61B10/0233—Pointed or sharp biopsy instruments
- A61B10/0283—Pointed or sharp biopsy instruments with vacuum aspiration, e.g. caused by retractable plunger or by connected syringe
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B10/02—Instruments for taking cell samples or for biopsy
- A61B2010/0208—Biopsy devices with actuators, e.g. with triggered spring mechanisms
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B10/02—Instruments for taking cell samples or for biopsy
- A61B2010/0225—Instruments for taking cell samples or for biopsy for taking multiple samples
Abstract
A biopsy device includes a body, a probe cannula, a cutter, a vacuum source, a tissue sample holder, and a flexible tube. The probe cannula extends distally from the body and defines an internal passage with a side aperture. The cutter is translatable relative to the probe cannula to sever a tissue sample received in the probe cannula. The vacuum source is in communication with the cutter. The tissue sample holder includes a vacuum port on the exterior surface to communicate with the vacuum source and a removable portion to hold solid tissue samples. The removable portion is selectively removable from the tissue sample holder and includes a straining member to separate fluids from solids. The flexible tube couples the tissue sample holder with the body such that the tissue sample holder is flexibly spaced away from the body.
Description
- The present application is a continuation of co-pending and commonly-owned U.S. patent application Ser. No. 12/775,780, entitled “BIOPSY DEVICE WITH INTEGRAL VACUUM ASSIST AND TISSUE SAMPLE AND FLUID CAPTURING CANISTER” to Hibner, filed on May 7, 2010, published as U.S. Patent Publication No. 2010/0228146, which is a continuation of U.S. Pat. No. 7,758,515, “BIOPSY DEVICE WITH INTEGRAL VACUUM ASSIST AND TISSUE SAMPLE AND FLUID CAPTURING CANISTER” to Hibner, et al. filed on May 25, 2007, which is a continuation in part of U.S. patent application Ser. No. 10/953,834, “BIOPSY APPARATUS AND METHOD” to Hibner et al., filed 29 Sep. 2004 (U.S. Pat. Publ. No. 2006/0074345), and the disclosures of which are hereby incorporated by reference in their entirety.
- The present invention relates in general to biopsy devices, and more particularly to biopsy devices having a cutter for severing tissue, and even more particularly to biopsy devices for multiple sampling with a probe remaining inserted
- When a suspicious tissue mass is discovered in a patient's breast through examination, ultrasound, MRI, X-ray imaging or the like, it is often necessary to perform a biopsy procedure to remove one or more samples of that tissue in order to determine whether the mass contains cancerous cells. A biopsy may be performed using an open or percutaneous method.
- An open biopsy is performed by making a large incision in the breast and removing either the entire mass, called an excisional biopsy, or a substantial portion of it, known as an incisional biopsy. An open biopsy is a surgical procedure that is usually done as an outpatient procedure in a hospital or a surgical center, involving both high cost and a high level of trauma to the patient. Open biopsy carries a relatively higher risk of infection and bleeding than does percutaneous biopsy, and the disfigurement that sometimes results from an open biopsy may make it difficult to read future mammograms. Further, the aesthetic considerations of the patient make open biopsy even less appealing due to the risk of disfigurement. Given that a high percentage of biopsies show that the suspicious tissue mass is not cancerous, the downsides of the open biopsy procedure render this method inappropriate in many cases.
- Percutaneous biopsy, to the contrary, is much less invasive than open biopsy. Percutaneous biopsy may be performed using fine needle aspiration (FNA) or core needle biopsy. In FNA, a very thin needle is used to withdraw fluid and cells from the suspicious tissue mass. This method has an advantage in that it is very low-pain, so low-pain that local anesthetic is not always used because the application of it may be more painful than the FNA itself. However, a shortcoming of FNA is that only a small number of cells are obtained through the procedure, rendering it relatively less useful in analyzing the suspicious tissue and making an assessment of the progression of the cancer less simple if the sample is found to be malignant.
- During a core needle biopsy, a small tissue sample is removed allowing for a pathological assessment of the tissue, including an assessment of the progression of any cancerous cells that are found. The following patent documents disclose various core biopsy devices and are incorporated herein by reference in their entirety: U.S. Pat. No. 6,273,862 issued Aug. 14, 2001; U.S. Pat. No. 6,231,522 issued May 15, 2001; U.S. Pat. No. 6,228,055 issued May 8, 2001; U.S. Pat. No. 6,120,462 issued Sep. 19, 2000; U.S. Pat. No. 6,086,544 issued Jul. 11, 2000; U.S. Pat. No. 6,077,230 issued Jun. 20, 2000; U.S. Pat. No. 6,017,316 issued Jan. 25, 2000; U.S. Pat. No. 6,007,497 issued Dec. 28, 1999; U.S. Pat. No. 5,980,469 issued Nov. 9, 1999; U.S. Pat. No. 5,964,716 issued Oct. 12, 1999; U.S. Pat. No. 5,928,164 issued Jul. 27, 1999; U.S. Pat. No. 5,775,333 issued Jul. 7, 1998; U.S. Pat. No. 5,769,086 issued Jun. 23, 1998; U.S. Pat. No. 5,649,547 issued Jul. 22, 1997; U.S. Pat. No. 5,526,822 issued Jun. 18, 1996; and US Patent Application 2003/0199753 published Oct. 23, 2003 to Hibner et al.
- At present, a biopsy instrument marketed under the trade name MAMMOTOME is commercially available from ETHICON ENDO-SURGERY, INC. for use in obtaining breast biopsy samples. This device generally retrieves multiple core biopsy samples from one insertion into breast tissue with vacuum assistance. In particular, a cutter tube is extended into a probe to cut tissue prolapsed into a side aperture under vacuum assistance and then the cutter tube is fully retracted between cuts to extract the sample, deposited upon an externally exposed surface accessible by a grasping instrument.
- With a long probe, the rate of sample taking is limited not only by the time required to rotate or reposition the probe but also by the time needed to translate the cutter. As an alternative to this “long stroke” biopsy device, a “short stroke” biopsy device is described in the following commonly assigned patent applications: U.S. patent application Ser. No. 10/676,944, “Biopsy Instrument with Internal Specimen Collection Mechanism” filed Sep. 30, 2003 in the name of Hibner et al. The cutter is cycled across the side aperture, reducing the sample time. Several alternative specimen collection mechanisms are described that draw samples through the cutter tube, all of which allow for taking multiple samples without removing the probe from the breast.
- In particular, in the cross referenced U.S. patent application Ser. No. 10/953,834, “BIOPSY APPARATUS AND METHOD”, these tissue samples are drawn by vacuum proximally through the cutter tube into a serial tissue stacking assembly that preserves the order of sample taking can be visually observed through a transparent lumen, and can serve as a transport container for samples taken during a pathology examination.
- Some clinicians prefer to capture a plurality of biopsy samples in a small canister attached to a proximal end of the biopsy instrument, such as described in U.S. Pat. No. 6,638,235 to Miller and U.S. Pat. Appl. Publ. No. 2006/0260994 to Mark. Vacuum draws these samples into the canister while allowing fluids to pass through tubing back to a fluid capturing receptacle. Periodically, the canister is disengaged from the biopsy instrument for removing each sample and sending to pathology professionals for assessment.
- While these known tissue storage approaches have a number of advantages, bodily tissues and fluids present a biological hazard to medical personnel that must be controlled while not interfering with the efficiency of the biopsy procedure.
- The present invention addresses these and other problems of the prior art by providing a biopsy device that has a probe cannula that is inserted into tissue to obtain a core biopsy sample by translating a cutter with the probe cannula. A pneumatic pressure differential is used to draw a severed tissue sample proximally from the probe cannula into a biopsy sample and fluid capturing canister sized to complete a full biopsy and therapy procedure and to provide a convenient method of transporting the same to a pathology professional for sample assessment. Contact with the biopsy samples and extracted bodily fluids is avoided in that the container need not be opened in a biopsy suite. In addition, the overall volume of single patient use disposable items is reduced by combining the fluid collection and sample collection containers into a single reservoir, thereby reducing the volume of product inventory and biohazard waste materials.
- These and other objects and advantages of the present invention shall be made apparent from the accompanying drawings and the description thereof.
- While the specification concludes with claims particularly pointing out and distinctly claiming the present invention, it is believed the same will be better understood by reference to the following description, taken in conjunction with the accompanying drawings in which:
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FIG. 1 is an isometric view of a self-contained biopsy system including a biopsy device with cover omitted in fluid communication with the biopsy sample and fluid capturing canister. -
FIG. 2 an isometric view of the biopsy device ofFIG. 1 with the cover and lower handle tray omitted and a reusable handpiece disengaged from a disposable probe assembly. -
FIG. 3 an exploded view from below, left of the disposable probe assembly ofFIG. 2 . -
FIG. 4 is an isometric view from left, aft of the disposable probe assembly ofFIG. 2 cut away to expose a pneumatic sequencing spool valve. -
FIG. 5 is an exploded view of the biopsy sample and fluid capturing canister ofFIG. 1 . -
FIG. 6 is a vertical cross section bisecting the biopsy sample and fluid capturing canister ofFIG. 1 . -
FIG. 7 is a vertical cross section bisecting an alternative biopsy sample and fluid capturing canister for the biopsy system ofFIG. 1 . - Turning to the Drawings, wherein like numerals denote like components throughout the several views, in
FIG. 1 , abiopsy device 10 includes areusable handpiece 12 and adisposable probe assembly 14. A self-containedbiopsy system 16 is formed by attaching a replaceable biopsy sample andfluid capturing canister 18. Thecanister 18 is generally sized to accommodate comfortably a volume of fluid that would be extracted, including saline flushing during a biopsy procedure with sufficient internal volume as well to hold biopsy tissue samples 19 (FIG. 6 ). As such, biohazards associated with bodily tissue and fluids are mitigated in that all such materials are readily transported from a biopsy suite for pathology assessment without the necessity of on-site access. - Tissue is drawn by vacuum assistance generated by
vacuum pump 20 integral to thereusable handpiece 12 into aside aperture 22 of aprobe cannula 24 of thedisposable probe assembly 14. The pneumatic vacuum assistance is achieved via a cutter tube 26 (exposed in the side aperture 22) that translates within acutter lumen 28 of theprobe cannula 24 and via anunderslung lateral lumen 30 that distally communicates to thecutter lumen 28 through holes or apertures (not shown) just proximal to a piercingtip 32 of theprobe cannula 24. ADC motor 34 in thereusable handpiece 12 powers rotation and translation of thecutter tube 26 to effect the severing. - The
disposable probe assembly 14 responds to the position of thecutter tube 26 by sequencing pneumatic communication between thebiopsy probe device 10 and thereplaceable canister 18 via avacuum supply line 36, aneedle vacuum line 38, and asample retraction line 40. Thevacuum supply line 36 receives vacuum pressure at its distal end from thevacuum pump 20 and proximally passes through and proximally is engaged over ahose nib 42 formed onto thecanister lid 44 of thecanister 18. Theneedle vacuum line 38 distally communicates to a pneumaticsequencing spool valve 46 in thedisposable probe assembly 14 and is frictionally held within a first protrudingcylindrical hose receptacle 48 formed onto acanister lid 44 of thecanister 18. Thesample retraction line 40 distally communicates to thedisposable probe assembly 14 and proximally passes through and is frictionally held within a second protrudingcylindrical hose receptacle 50. - The
reusable handpiece 12 includes apneumatic manifold 52 having an upperright port 54 connected to thevacuum supply line 36 and an upperleft port 56 open to atmosphere. It should be appreciated that the manifold 52 serves as a mounting for thevacuum pump 20 that generates the pressure differential between theports - With particular reference to
FIGS. 1-2 , insertion of theprobe cannula 24 into tissue is integrally supported by the piercingtip 32 attached at the distal end as well as a longitudinal jack hammer motion to theprobe cannula 24 selected by positioning aslide button 58 distally and depressing aforward motor button 60. In response, theDC motor 34 drives atransmission section 61 grounded to a top cover 64 (depicted in phantom inFIG. 1 ) of thereusable handpiece 12 to longitudinally reciprocate an internalcarriage frame assembly 62 that is engaged for movement with theprobe cannula 24. With theslide button 58 proximally positioned, depression of theforward motor button 60 causes theDC motor 34 to advance and rotate thecutter tube 26, depicted inFIG. 1 as having been fully distally translated, closing theside aperture 20. Depression of areverse motor button 68 causes thecutter tube 26 to retract. Depression of amode button 70 may cause other functions to be performed. An additional feature contemplated but not depicted includes using themode button 70 to selectively communicate a saline supply to thelateral lumen 30 to flush theprobe cannula 24. It should be appreciated that thebiopsy device 10 includes a minimum of “tethers” that would impede use, pose a tripping hazard, prevent use in an austere clinical setting, or extend set-up time. - Alternatively, instead of “hard-walled”
lateral lumen 30 separated from thecutter lumen 28 along its length, applications consistent with the present invention may have a cylindrical probe cannula (not depicted) wherein thecutter tube 26 is positioned off-center to translate across a side aperture. A “soft-walled” lateral lumen may then be defined as a space between an outer diameter of the cutter tube and an inner diameter of the cylindrical probe cannula. - In
FIGS. 1-4 , thedisposable probe assembly 14 has abottom cover 78 with a distal probe mount cover 80 that assists in supporting theprobe cannula 24 while allowing the longitudinal jack hammer motion. A plurality of lockingtabs 82 with lockingedges 84 extend upwardly through pass-through slots (not shown) formed in the periphery of a lower handle tray 86 (FIG. 1 ) attached to thecover 64 of thereusable handpiece 12 to resiliently extend outwardly into engaging contact with the slots facilitating replacement of thedisposable probe assembly 14.Relieved areas 88 are formed behind each lockingtab 82 in atop extension member 89 that surrounds aprobe support body 90. The combination covers a cavity defined by thebottom cover 78, which allows depression of the lockingtabs 82 to unlock thedisposable probe assembly 14 to install another identical or similar assembly. - A proximal end of the
cutter tube 26 receives acutter gear 92 having distal and proximal reduced diameter bearing surfaces 94, 96 on each longitudinal side of a rotationspur gear section 98, which engage thereusable handpiece 12 for rotation and for longitudinal translation through a distally open longitudinal aperture 100 (FIG. 3 ) formed in thebottom cover 78. - In
FIGS. 2-4 , thedisposable probe assembly 14 has movable components that respond to the actuating motions of thereusable handpiece 12. Theprobe support body 90 includes adistal probe mount 106 that is received within the distal probe mount cover 80 of thebottom cover 78. Proximal to and underlying a longitudinal axis of thedisposable probe assembly 14 defined by aprobe guide hole 108 passing through thedistal probe mount 106, a vertically openlongitudinal slot 110 is formed into anecked portion 112 of theprobe support body 90. - With particular reference to
FIGS. 3-4 , at a proximal end of thelongitudinal trough 110, a distally open, longitudinally aligned valve bore 114 is formed in aproximal block portion 116 of theprobe support body 90. Central andproximal ports proximal block portion 116 and adistal port 122 communicates laterally from a right side of theproximal block portion 116. A right distal ninety-degree fitting 124 communicates between thedistal port 122 and anintake filter 128. - A valve control rod 130 has a prismatic
distal actuating portion 132 extending distally out of the valve bore 114 constrained for only longitudinally movement within thelongitudinal slot 110. The valve control rod 130 also has avalve spool portion 134 that longitudinally translates within the valve bore 114 to selectively position between a first position and a second position. A proximal O-ring 136 near a proximal end of thevalve spool portion 134 and a distal O-ring 138 are spaced such that the first position entails the O-rings distal ports 118, 122 (i.e., distal position of the valve control rod 130) and the second position entails the O-rings central ports - A
distal vacuum conduit 140 has one end attached to a center ninety-degree fitting 142 attached to thecentral port 118 and the other end attached to a probe union ninety-degree fitting 144 that communicates with thelateral lumen 30. Theneedle vacuum line 38 has its distal end attached to a proximal ninety degree fitting 146 attached to theproximal port 120. - A front actuation finger 148 (
FIG. 2 ) of afront carriage 150 is received within an upwardlyopen socket 152 formed on a left side of avacuum control shuttle 154 having a lateral concave recessedband 156 shaped to encompass with a clearance a lower portion of the rotationspur gear section 98 of thecutter gear 92. Thevacuum control shuttle 154 is laterally sized to bridge thelongitudinal slot 110 with a downwardly projecting vacuum actuator lug 157 (FIG. 3 ) attached to an underside of theshuttle 154 that is received within a vertically openelongate delay slot 158 of thedistal actuating end 132 of the vacuum control rod 130. Thus, the rather long cutter travel is translated into a smaller valve movement as the shuttle reaches either full proximal or full distal travel. - A
sample retraction line 40 is proximally held by atube guide 162 extending inwardly from proximal end of thetop extension member 89 of thedisposable probe assembly 14. A distal end of the longitudinally alignedsample retraction line 40 is received through a reardynamic seal 164 attached to a proximal end of thecutter gear 92, and into thecutter tube 26. - The
reusable handpiece 12 of thebiopsy device 10 is substantially as described in greater detail in four commonly-owned and co-pending U.S. patent applications (1) Ser. No. 11/198,558, “Biopsy Device With Replaceable Probe And Incorporating Vibration Insertion Assist And Static Vacuum Source Sample Stacking Retrieval” to Hibner et al., filed 8 Aug. 2005, published as US 2007-0032741 A1; (2) Ser. No. 11/736,117, “Tissue Sample Revolver Drum Biopsy Device” to Hibner et al., filed 17 Apr. 2007; (3) Ser. No. 11/753,665, “Tissue Sample Serial Capturing Biopsy Device” to Hibner, filed 25 May 2007; and (4) Ser. No. 11/465,143 “Vacuum Syringe Assisted Biopsy Device” to Hibner, filed 17 Aug. 2006, published as US 2007-0032743 A1, the disclosures of all of which are hereby incorporated by reference in their entirety. An aft carriage is omitted from the illustrative version for clarity as not being necessary, although a common reusable handpiece may include a second carriage for mounting to other types of disposable probe assemblies as described in the cross referenced applications. - In
FIGS. 5-6 , the biopsy sample andfluid capturing canister 18 has a tapered cylindricalfluid container 170 whose upper band-shaped lip seals 172 to and is encompassed by a downwardcircumferential lip 174 of thecanister lid 44. Asample collector basket 176 has taperedcylindrical sides 178 shaped to come to rest at approximately a midpoint of the interior of thefluid container 170. Near the top of the taperedcylindrical sides 178 of thesample collector basket 176, aperforated disk 180 is horizontally attached to serve as support to afilter disk 182 adhered to an undersurface. The combination acts in a similar fashion to a drip coffee filter basket. About approximately a third of the upper circumference of thecylindrical sides 178 of thesample collector basket 176, a raisedside wall portion 184 culminates in a horizontal and inwardly projectingannular ring portion 186 that serves as a handle for drawing thesample collector basket 176 out of thefluid container 170. - The center of the
perforated disk 180 of thesample collector basket 176 includes afirst hose receptacle 188 registered for theneedle vacuum line 38 to pass on downward into afluid collection reservoir 190 formed within thefluid container 170 below theperforated disk 180 of thesample collector basket 176. The center of theperforated disk 180 of thesample collector basket 176 also includes asecond hose receptacle 192 registered for thesample retraction line 40 to pass on downward into thefluid collection reservoir 190. It should be appreciated that caps or a closed lid (not shown) may be used to seal the biopsy sample andfluid capturing canister 18 after thelines - With reference to
FIGS. 4 and 6 , in use, thecutter 26 is initially distally positioned as theprobe cannula 24 is inserted into tissue. Thevacuum motor 20 operates providing a low pressure within thefluid collection reservoir 190 inside of thereplaceable canister 18 viavacuum supply line 36. Ahydrophobic filter 198 prevents fluids from reaching thevacuum motor 20. The low pressure communicates to thecutter tube 26 via thesample retraction line 40. After theprobe cannula 24 is inserted into tissue beside a suspicious lesion, thecutter tube 26 is retracted. Thespool valve 46 is in the first position, with thevacuum lumen 30 vented to atmosphere viacentral port 118 anddistal port 122. The retraction of thecutter gear 92 causes theshuttle 154 to retract correspondingly with itsdownward lug 152 moving within thedelay slot 158 of thedistal actuating portion 132 of the valve control rod 130. Once thecarriage 150 of thereusable handpiece 12 reaches full proximal travel, thelug 157 contacts the proximal end of thedelay slot 158 and changes the pneumaticsequencing spool valve 46 from the first position to the second position. Thus, thevacuum lumen 30 is also exposed to vacuum via central andproximal ports spool valve 46 that communicates via theneedle vacuum line 38 to thereplaceable container 18, exposing the suspicious lesion to the vacuum assistance from bothlines side aperture 20. Thespool valve 46 stays in this configuration as thecutter tube 26 is advanced distally while rotating to sever thetissue sample 19. As theshuttle 154 approaches its distal-most position, thelug 157 contacts the distal end of thedelay slot 158 of thedistal actuating portion 132 of the valve control rod 130, changing to the first position wherein thevacuum lumen 30 is vented to atmosphere and thetissue sample 19 is retracted into thereplaceable container 18 by vacuum pressure via thesample retraction line 40. - Once
tissue samples 19 are collected in thereplaceable container 18, thereplaceable container 18 is removed from thebiopsy device 10 and transported to a pathology professional for sample assessment. - Alternately, the bodily fluids are drained from the container and replaced with tissue preparation fluid (e.g. Formalin) prior to being sent off for pathological assessment. The bodily fluids are removed from the
replaceable canister 18 by removing thecanister lid 44,needle vacuum line 38, and thesample retraction line 40 from thereplaceable canister assembly 18. While supporting the tapered cylindricalfluid container 170 and theannular ring portion 186 located onsample collector basket 176, the fluids are poured from the tapered cylindricalfluid container 170 with thetissue samples 19 remaining in the tapered cylindricalfluid container 170. Thesample collector basket 176 and attachedfilter disk 182 are then removed form the tapered cylindricalfluid container 170 and tissue preparation fluid (e.g. Formalin) is poured into the tapered cylindricalfluid container 170. A canister lid (not shown) without hose receptacles or nibs is attached to the tapered cylindricalfluid container 170 prior to transporting to a pathology professional for sample assessment. Alternately, after the fluids are poured from the tapered cylindricalfluid container 170, thesample collector basket 176, and attachedfilter disk 182 are removed from the tapered cylindricalfluid container 170. Thetissue samples 19 are transferred from the tapered cylindricalfluid container 170 into a container (not shown) containing tissue preparation fluid (e.g. formalin) prior to transportation to a pathology professional for sample assessment. - Another alternate embodiment of a biopsy sample and
fluid capturing canister 18′ is depicted inFIG. 7 as including a fully enclosedsample collector basket 192 with a lowerperforated disk 194 and filter 196 to fully contain thetissue samples 19 as they exitsample retraction line 40. The lowerperforated disk 194 and filter 196 act to separate thetissue samples 19 from bodily fluids. Oncetissue samples 19 are collected in thereplaceable container 18, the fully enclosedsample collector basket 192 can be removed form thereplaceable container 18 and placed directly into a container (not shown) containing tissue preparation fluid (e.g. Formalin) prior to transportation to a pathology professional for sample assessment. - It should be appreciated that any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated material does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein, will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.
- While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art, given the benefit of the present disclosure, that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the spirit and scope of the appended claims.
- For example, as a means to further reduce the size and weight of the
overall biopsy device 10, theDC motor 34 employed to rotate and translate thecutter tube 26 can also drive thevacuum pump 20 via appropriate gearing. - For another example, although the integral vacuum pump advantageously makes the
biopsy device 10 more self-sufficient in austere clinical situations, applications consistent with aspects of the invention may employ a separate vacuum source. - As another example, while a DC motor integral to the reusable handpiece has certain advantages in the illustrative version, applications consistent with aspects of the invention may utilize a motor comprising materials compatible with use in a strong magnetic environment (e.g., magnetic resonance imaging) or remotely placed (e.g., via a drive cable).
- As another example, while a pneumatically closed system between the
replaceable container 18 and thebiopsy device 10 provides various advantages, applications consistent with aspects of the invention may provide separate vacuum source connections to the biopsy device and to thereplaceable container 18.
Claims (21)
1.-20. (canceled)
21. A biopsy device comprising:
(a) a probe cannula defining an internal passage and having a side aperture;
(b) a cutter translatable relative to the probe cannula to sever a tissue sample received in the probe cannula;
(c) a vacuum source in communication with the cutter;
(d) a container;
(e) a tissue sample holder located in the container, wherein the tissue sample holder is configured to capture solid tissue samples and hold the solid tissue samples therein while allowing fluid to escape the tissue sample holder;
(e) a flexible tube configured to communicate solid tissue samples from the cutter to the tissue sample holder; and
(f) a dynamic seal coupling the flexible tube to the cutter such that the cutter is configured to rotate and translate relative to the flexible tube.
22. The biopsy device of claim 21 , further comprising an elbow adapted to receive the solid tissue samples in a first direction and direct the received solid tissue samples in a second direction lateral to the first direction.
23. The biopsy device of claim 22 , wherein the tissue sample holder includes a straining member, wherein the straining member is positioned laterally relative to the second direction.
24. The biopsy device of claim 21 , wherein the tissue sample holder includes a straining member, wherein the straining member defines a horizontal plane.
25. The biopsy device of claim 24 , further comprising a second flexible tube, wherein the second flexible tube passes through the horizontal plane defined by the straining member and terminates at an end within the container.
26. The biopsy device of claim 24 , further comprising a vacuum lumen communicating to a distal end of the probe cannula and a second flexible tube between the container and the vacuum lumen, wherein the second flexible tube is configured to communicate vacuum with the vacuum lumen.
27. The biopsy device of claim 26 , wherein the second flexible tube is positioned above the plane defined by the straining member and terminates at a free end within the tissue sample holder.
28. The biopsy device of claim 27 , further comprising a switching assembly responsive to the cutter, wherein the switching assembly is operatively configured to expose the vacuum lumen to the vacuum source in response to the cutter being retracted to prolapse tissue into the side aperture, wherein the switching assembly is configured to be responsive to the cutter being distally positioned to expose the vacuum lumen to an increased pressure to effect retraction of severed tissue to the container via the conduit.
29. The biopsy device of claim 21 , wherein the container defines a fluid reservoir, wherein at least a portion of the fluid reservoir is defined by the tissue sample holder.
30. The biopsy device of claim 29 , wherein the tissue sample holder includes a removable portion, wherein the removable portion of the tissue sample holder includes a basket, wherein the removable portion includes a straining member, wherein a vacuum port is positioned above the straining member.
31. The biopsy device of claim 21 , wherein the dynamic seal is physically attached to a distal portion of the cutter.
32. The biopsy device of claim 21 , further comprising a motor assembly operatively configured to translate the cutter to sever a tissue sample.
33. A biopsy system comprising:
(a) a biopsy device including:
(i) a body,
(ii) a probe cannula defining an internal passage and having a side aperture, and
(iii) a cutter translatable relative to the probe cannula to sever a tissue sample received in the probe cannula;
(b) a sample collection assembly including:
(i) an outer container,
(ii) a lid couplable to the outer container, and
(ii) a tissue sample holder disposed within the outer container such that the tissue sample holder is configured to separate solid tissue samples from fluid as vacuum is communicated through the outer container, thereby holding tissue samples severed by the cutter; and
(c) a first tube extending from the outer container to the biopsy device such that the first tube is configured to communicate tissue samples from the biopsy device to the tissue sample holder, wherein at least a portion of the first tube includes an elbow portion configured to direct tissue samples toward the tissue sample holder.
34. The biopsy system of claim 33 , wherein the tissue sample holder includes a floor defining a plurality of openings, the openings configured to strain solid tissue samples from fluid.
35. The biopsy system of claim 33 , wherein the first tube terminates at a proximal end located above at least a portion of the tissue sample holder.
36. The biopsy system of claim 33 , further comprising a vacuum conduit, wherein the tissue sample holder includes a strainer, wherein the strainer defines a straining plane, wherein the vacuum conduit includes a proximal end that is disposed below the straining plane such that the vacuum conduit is configured to draw fluid through the strainer of the tissue sample holder.
37. A biopsy system comprising:
(a) a biopsy device including:
(i) a first body,
(ii) a second body selectively attachable to the first body,
(ii) an elongate needle extending from the second body and defining an internal passage and a side aperture, and
(iii) a cutter translatable and rotatable relative to the side aperture of the elongate needle to sever a tissue sample received in the side aperture;
(b) a sample collection assembly including:
(i) an outer container,
(ii) a lid couplable to the outer container, and
(ii) a tissue sample holder disposed within the outer container such that the tissue sample holder is configured to separate solid tissue samples from fluid as vacuum is communicated through the outer container, thereby holding tissue samples severed by the cutter, wherein the tissue sample holder includes a removable portion the configured for removal from the outer container and for insertion into a formalin container to store tissue samples; and
(c) a first tube extending from the outer container to the biopsy device such that the first tube is configured to communicate tissue samples from the biopsy device to the tissue sample holder, wherein at least a portion of the first tube includes an elbow portion configured to direct tissue samples toward the tissue sample holder.
38. The biopsy system of claim 37 , a second tube communicating between the outer container of the sample collection assembly and a vacuum source, wherein the second tube is configured to supply vacuum to the first tube to transport tissue samples through the first tube to the tissue sample holder.
39. The biopsy system of claim 38 , wherein the cutter and the first tube each define an inner surface coated with a hydrolubricous material configured to aid in transport of tissue samples.
40. The biopsy system of claim 37 , wherein the first body is configured to be reused one or more times after a biopsy procedure, while the second body is configured for use in only a single biopsy procedure.
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US15/674,139 US20170367687A1 (en) | 2004-09-29 | 2017-08-10 | Biopsy device with integral vacuum assist and tissue sample and fluid capturing canister |
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US15/266,500 Expired - Fee Related US9757100B2 (en) | 2004-09-29 | 2016-09-15 | Biopsy device with integral vacuum assist and tissue sample and fluid capturing canister |
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EP (1) | EP1642533B1 (en) |
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2004
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2005
- 2005-08-29 AU AU2005204322A patent/AU2005204322A1/en not_active Abandoned
- 2005-09-28 DE DE602005003526T patent/DE602005003526T2/en active Active
- 2005-09-28 CN CNA2005101054974A patent/CN1754512A/en active Pending
- 2005-09-28 JP JP2005282437A patent/JP2006095312A/en not_active Abandoned
- 2005-09-28 CA CA002521527A patent/CA2521527A1/en not_active Abandoned
- 2005-09-28 EP EP05256035A patent/EP1642533B1/en active Active
- 2005-09-29 BR BRPI0504208-9A patent/BRPI0504208A/en not_active IP Right Cessation
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2006
- 2006-08-02 HK HK06108595A patent/HK1088199A1/en not_active IP Right Cessation
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2007
- 2007-05-25 US US11/753,665 patent/US7753857B2/en not_active Expired - Fee Related
- 2007-05-25 US US11/753,952 patent/US7758515B2/en not_active Expired - Fee Related
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2010
- 2010-05-07 US US12/775,780 patent/US8956306B2/en not_active Expired - Fee Related
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2014
- 2014-02-25 US US14/188,744 patent/US9265485B2/en active Active
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2016
- 2016-01-12 US US14/993,645 patent/US9468425B2/en active Active
- 2016-09-15 US US15/266,500 patent/US9757100B2/en not_active Expired - Fee Related
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2017
- 2017-08-10 US US15/674,139 patent/US20170367687A1/en not_active Abandoned
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Also Published As
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US7753857B2 (en) | 2010-07-13 |
AU2005204322A1 (en) | 2006-04-13 |
US20140171823A1 (en) | 2014-06-19 |
US20160120520A1 (en) | 2016-05-05 |
BRPI0504208A (en) | 2006-05-09 |
EP1642533A1 (en) | 2006-04-05 |
EP1642533B1 (en) | 2007-11-28 |
CN1754512A (en) | 2006-04-05 |
US20070255173A1 (en) | 2007-11-01 |
HK1088199A1 (en) | 2006-11-03 |
DE602005003526T2 (en) | 2008-10-23 |
US9265485B2 (en) | 2016-02-23 |
US20070255174A1 (en) | 2007-11-01 |
US8956306B2 (en) | 2015-02-17 |
CA2521527A1 (en) | 2006-03-29 |
JP2006095312A (en) | 2006-04-13 |
DE602005003526D1 (en) | 2008-01-10 |
US9468425B2 (en) | 2016-10-18 |
US20060074345A1 (en) | 2006-04-06 |
US20100228146A1 (en) | 2010-09-09 |
US9757100B2 (en) | 2017-09-12 |
US20170000468A1 (en) | 2017-01-05 |
US7758515B2 (en) | 2010-07-20 |
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