WO2016115433A1 - Mécanisme et procédé d'actionnement d'extrémité de travail distale de dispositif d'excision - Google Patents

Mécanisme et procédé d'actionnement d'extrémité de travail distale de dispositif d'excision Download PDF

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Publication number
WO2016115433A1
WO2016115433A1 PCT/US2016/013551 US2016013551W WO2016115433A1 WO 2016115433 A1 WO2016115433 A1 WO 2016115433A1 US 2016013551 W US2016013551 W US 2016013551W WO 2016115433 A1 WO2016115433 A1 WO 2016115433A1
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WIPO (PCT)
Prior art keywords
sheath
beak
distal
articulable
rotation
Prior art date
Application number
PCT/US2016/013551
Other languages
English (en)
Inventor
James W. Vetter
Original Assignee
Transmed7, Llc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US14/599,481 external-priority patent/US10231750B2/en
Application filed by Transmed7, Llc filed Critical Transmed7, Llc
Publication of WO2016115433A1 publication Critical patent/WO2016115433A1/fr

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Classifications

    • 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
    • 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

Definitions

  • Embodiments relate to medical devices and methods. More particularly, embodiments relate to stereotactic table mounted or hand-held single insertion, multiple sample soil tissue excisional biopsy and coring devices and corresponding methods for retrieving multiple soft tissue biopsy- samples using a single insertion.
  • Embodiments are drawn to medical devices and methods that are used for core biopsy procedures.
  • a biopsy coring/delivery device als referred to herein as an excisional device, may be configured to retrieve multiple samples of normal and/or abnormal appearing tissues during a single insertion through the skin (percutaneous procedure).
  • Embodiments may comprise structures and fenctioiiainy for different phases of a multi-phase biopsy procedure, which may be performed, by hand or through attachment to a stereotactic table or Magnetic Resonance imaging (MRI) stage.
  • MRI Magnetic Resonance imaging
  • embodiments may comprise a pre-treafoiem of the area and/or of the abnormal tissue, or the delivery of tracer materials for tracking the potential spread or flow patterns of abnormal tissues (such as cancerous tissues) through die process of metastasis.
  • Embodiments may also comprise an intra-proeedure delivery of medications ' that may anesthetize tissues at the site, or that may deli ver other therapeutic agents such as, for example, pro-coagul nts.
  • Embodhnents may also be configured for the delivery of post-procedure materials such as medications, implantable materials for cosmetic purposes- marking elements and othe implantable elements for later imaging reference, or other purposes.
  • Embodiments may also be configured for imaging of the surrounding tissaes during pre-operative, intraoperative, and/or post-operative phase of the device's clinical use. Embodiments may als be configured to allow for ablation of tissue daring pre-, intra-, and/or post-operative phases. Embodiments of the biopsy device, along with associated related subcomponents described herein, may be configured to retrieve solid, contiguous and/or fragmented tissues as well as liquid and semi-solid tissues for analysis,, diagnosis and treatme t Embodiments may he portable, disposable or reusable and ma be electrically,, mechanically and/or manually powered and operated.
  • FIG. 1 is a perspective view of a. core biopsy device according to one embodiment
  • FIG. 2 is a perspective view of a movable, rotatable seoopida-shaped outer sheath with a movable, rotatable cutting element and transport helix attached, according to one embodiment
  • FIG. 3 is a side view of air outer sheath and articulated beak and helical element, according to one embodiment
  • FIG. 4 is a side view of an outer sheath and rotating inner beak and helical element,, according to one embodiment
  • FIG. 5 is an overhead view of a beak element with living hinge closing against a scoopula-shaped outer sheath, according to one embodiment
  • Fig , 6 is a side vie w of an outer sheath and inner cutting elemen and helical element, according to one embodiment
  • FIG. 7 is a side view of an outer sheath and cutting element, according to on embodime t;
  • FIG. 8 is a side view of anothe embodiment of an articulated beak and attachment mechanism, according to one embodiment
  • Fig. 9 is a side view of the working elements of Fig, 8, in open beak configuration ⁇ according to one embodiment
  • Fig, 1.0 is a side view of the rotating inner cutting element and outer rotatable scoopola-shaped element; according to one embodiment
  • Fig, 11 is a side view of another ⁇ embodiment of an outer sheath and inner cutting element;
  • 00 ⁇ 4 ⁇ Fig, 12 is a top iew of an ⁇ titer sheath and cutting element aligned at ts distal tip, according to one embodimen ;
  • fOOlSj Fig, 13 is m end on perspective view of at* outer sheath and inner cutting element in over center open configuration, according to one embodiment;
  • FIG. 14 A is an end -on perspective view of an outer sheath and inner cutting element in rotated position, according to one embodiment
  • FIG. J.4B is an end on perspective view of an outer sheath and inner cutting element in further rotated position, according to one embodiment
  • Fig, I SA is a perspective view of a split-tube single beak assembly in retracted position against an oute sheath with seoopi a, according to one embodiment
  • FIG. I SB is a perspective view of a split-tube single beak assembly extending part way out of an outer sheath, witli the beak open over center, according to one embodiment
  • FIG. J SC is perspective view of split-tube single beak assembly in fully extended position at the end of the scoopula of an outer sheath for part off of a ' tissue specimen and for other purposes, according to one embodiment;
  • [002 jj Fig. 16 A shows details of a work element according to one embodiment
  • FIG. 17B shows a detail of an element of an excisiona! deviee s according to one embodiment
  • Fig. 18 shows a proximal sheath comprisin a plurality of elongated slots disposed in a spiral pattern around a longitudinal axis, according to one embodiment
  • FIG. 1 shows details of a proximal sheath, beak actuation elements and inner helical element of an excisional device according to one embodi ment
  • ⁇ * ⁇ 27] -Fig. 20 shows an onter difierentially rotating or rotataMe pxti& sheath, which may " imctkm as a true owter sheath inchwimg an op n but nan- scoopula shaped extremity or as a distal sheath of m exeislonal device ' ccording to embodiments;
  • FIG. 21 a view of a twin beak work assembl of an exctsionaJ device with the distal sheatb and outer sheath removed, according to one embodiment
  • Fig. 22 is a view of a single beak work assembly of an exeisionai device with the outer sheath, dista sheath and proximal sheath removed, according to one embodiment;
  • FIG. 23 shows a top -view of a -mechanical arrangement for cutting element
  • FIG. 24 is an illustration of a cam aid cam follower arrangement, according to one embodiment
  • Fig. 25 is a side vie w of a cutting element actuation mec an sm, according to one embodiment
  • Fig. 26 A is a side view of the internal and external features of a biopsy device according to one embodiment
  • Fig. :26B is a f ront end-on view o f the shape of a ' biopsy device, according to one embodiment
  • Fig. 26C is a perspectiv view of a transfer m gazine, according to one embodiment
  • Fig. 26t> is a cross sectional view of a transfer magazine according to one embodiment, taken along line A A' of Fig, 26C;
  • Fig, 26E is a perspective view of a hinged, clamshell e di ent of a transfer magazine, according to one embodiment
  • Fig. 27 A is a first view of a stereotactic table adapter for a biopsy device, according to one embodiment.
  • Fig. 27B is a second view of a stereotactic adapter for a biopsy device, according to one embodiment
  • Fig, 27C is a side view of an adapter p tforn3 ⁇ 4 suitable for a stereotactic: table stage, and on which an excisional device may be coupled, according to one embo iment.
  • fl04!J Fig, 2SA is a perspective exploded view' of a capstan assembly, according to one embodiment.
  • Fig. 2 SB is a top view of a capstan assembly, according to one embodiment
  • Fig. 28C is a top view of a capsta assembly in a first configuration, according to one embodiment
  • FIG. 28D is a top view of a capstan assembly in a second configuration, according to one embodiment
  • Fig. 29A shows structure of an element of a exeisionai device according to one embodiment.
  • Fig. 296 shows structere of an additional element of an excisional device according to one embodiment.
  • Fig. 29C snows still more strtjcaire of an element of an exCisional device according to one embodiment
  • Fig, 29D shows further structure of an exeisionai device according to one embodiment.
  • Fig, 30A shows a monolithic beak assembly of an excisions! device according to one embodiment
  • Fig. 30B shows a detail of a proximal end of a monolithic beak assembly of an exeisionai device according to one embodiment.
  • Fig, 31 snows the distal end of a proximal sheath of an exeisionai device according to one embodiment.
  • FIG. 32 shows an assembly comprising the monolithic beak assembly and the proximal sheath of an exeisionai device according to one embodiment.
  • Fig. 33 shows the distal end of a distal sheath of an exeisionai device, accordin to one embodiment
  • Fig. 34 shows a» assembly comprising a monolithic beak assembly, a proximal sheath and ; : distal she th., aceordiug to one embodiment.
  • Fig, 35 shows the distal portion of an e cisiona! device according to one
  • Fig, 36 is a flowchart of a method ⁇ according to one embodiment
  • Fig. 37 is a flowchart of a method: of posi tioning a biopsy device, according to one embodiment,
  • Fig. 38 is a flowchart of another method according to one embodiment
  • Fig. is a view of distal portion of an excisions! device according to one embodiment
  • Fig, 0 is a view of a distal portion, of an. exelsional device according to one embodiment
  • Fig. 4 is a flowchart of a method according to one embodiment
  • Fig. 1 shows a biopsy ojr 5 more generally, an excisi onal device 10 according to embodiments.
  • the excisional biopsy device 10 may comprise a. tubular coring and transport- assembly 11 thai may* according to one embodiment* have a distal end defining a seooputa shape.
  • the distal end may have a shape that differs from the seoopula shape and that differs from that shown in the figures.
  • the seoopula forms part o an outer sheath, (also called “outer tube,” or “non-rotating outer sheath,” or “differentially rotating outer sheath,” or ''!manualiy rotating outer : he3th ⁇ , ⁇ : of appropri ate dimensions to ret ve a sing le or multiple core samples of tissue (not shown) that Is are sufficient to provide the desired clinical diagnostic or therapeutic result
  • the scoopula may be made of materials, or include coatings, tha may enhance penetration arid/or hentostasis, and may also he configured to include external features that enhance penetration and/or stabilization withi the tissue, for example, spirally-disposed ridges • and ox grooves, as well as features such as axial slits to enhance visibility under guidance modalities such a$ ultrasound.
  • Such an appropriate dimension may e, for example * about 4 inches in length, in addition to a forward excursion of the tubu lar coring and transport assembly 11 during the coring phase. It is to be understood, -However, thai, the foregoing dimensions and any dimensions referred to herein are exemplary in nature only. Those of skill in this art will recognize that other dimensions and/or configurations may he implemented, depending upon the application, and that the fi ul r coring and transport assembly 1 and its subparts, as well as oilier elements of the device, could be of any length or dimension, all of which are considered within the scope of this disclosure.
  • outer sheath may be removable such that, according to one embodiment, such outer sheath may be fully detached from the biopsy device 10 and thus be temporarily placed, or left in place in the body to enable delivery through its lumen of substances or othe devices during preoperative, biopsy., and/or postoperative phases,
  • the biopsy devi ce ! ⁇ may be configured for hand-held operation and may comprise an ergonomically comfortable and secure handle 12 at its proximal end from which the tubular coring and transport assembly 1 1 extends so that the biops device 10 ma be easily i ected with one han while the other baud is free to hold a guiding probe such as an ultrasound transducer.
  • a guiding probe such as an ultrasound transducer.
  • embodiments may readily be configured to fit onto any number of guiding devices such as a stereotactic table imaging stage or equipment associated with other guidance modalities such as Magnetic Resonance imaging (MR! (not shown).
  • MR Magnetic Resonance imaging
  • one embodiment of the biopsy device 10 may comprise one or more sharp, rotating or non-rotating cutting elements 13 (herein, alternativel and- collectively referred to as "cutting element,” “work element, "beak,” “beak assembly, * * articulable beak * or “beak element” or '%eak; elements * -) projecting forward from tie distal free end of the removable tubular coring and transport : assembly 1.1.
  • the (one or BOOTS) cutting element 13 may travel distaijy up to the end of a distal scoopula for the purposes of forward penetration, coring and/or parti ng off of the cots sample in a combtaed forward cutting and side cuttin motion in reference to the scoop ilia.
  • Such a scoopula itself may be composed of one or more elements, suc as a series of small forward projections, which in the aggregate have the form. ' of a scoopula.
  • the tubular coring and transport assembl 11 may comprise a plurality of components, which plurality may be configured to transmit rotational movement and opening/closing actions to the rotating or non-rotating cutting beak elements 13.
  • the ''tubular description of the coring and transport assembly 11 expressly encompasses any cross sectional shape ami size, of an length and may in addition be flex ible, as for example, to na vigate through vascular spaces or around sensitive structures within soft tissues.
  • th term non-rotating also includes other cutting actions such as axla!!y aligned, fore and aft movements of cutter elements, which may be powered or manually actuated. Such actions may consist of slow ' "jack-hammering" movements alone or in combination, with rotation, or may include high frequenc motions such as ultrasonic vibrations.
  • Cutting may also be carried out alone or in combination with these motions and/or rotation (rotation including continuous in one direction, cyclic reversing or in oscillation) by energizing cutting surfaces with modalities or combinations of modalities such as laser, radio-frequency, microwave, beat and cheniicafarnong others,
  • Emhodiruents include tailoring of excursion Of fore and a ft and/or rotational movements such that they may be configured to preferentially cut core specific tissues. For example, shorter freque tly repetitious excursions could preferentially sever hard tissue leaving soft tissue intact, while longer excursions that exceed certain soft tissue elastic limits could bias cuttin to ards more effective soft tissue severing.
  • tubular corin and transport assembly 11 may also be con figured to transfer the core samplers) back proxitnaily along the internal length of a inner lumen defined ' within the tubular coring and transport assembly 1 to the handl 12 and to thetmnsrer compartment or maga ine 27,
  • the biopsy device 10 may comprise a handle 12, which handle 12 may comprise and/or be coupled to mechanical components (not shown in this figure) configured to drive the distal tubular coring and transport assembly 11 to enable t to discharge its: coring, ttarrsport, part-oil and delivery functions.
  • handle 12 may comprise and/or be coupled to mechanical components (not shown in this figure) configured to drive the distal tubular coring and transport assembly 11 to enable t to discharge its: coring, ttarrsport, part-oil and delivery functions.
  • one ⁇ embodiment nay com rise a dista!ly-disposed beak element 13 that may. comprise one or more sharp cutting tip blades configured, together with a distal seoopula ortion of an.
  • the present biopsy device to repeatedly core and retrieve multiple samples (not shown) durin a single insertion and then, accumulate the cored samples in a transfe magazine 27 means that with a single penetration through the skin of- for example, a human breast, the operator can sample multiple areas without causing additional trauma that would otherwise be associated by repeatedly removing the biopsy device 10 each time a sample is taken, and reintroducing the biopsy device 10 back into the patient to take additional core samples.
  • the handle 12 may also comprise and/or be coupled ' t (internal or external) mechanical components ' (not shown) and features for vacuum-assisted fluid e vacuation as well as components -configured for the delivery of materials such as, for example, a variety of medications, tracer materials, implantable elements, marker elements and diagnostic and therapeutic devices.
  • the tubular coring and transport, assembly 11 may be configured such as to create the smallest possible caliber (e.g., outside diameter) of coring rube (tubular coring and transport assembly 1.1) with, a range of (for example) about i poiuhel6 gauge to about 8 gauge diameter, while providing a sufficientl large diameter of core sample obtained to be clinically useful.
  • the tubular coring and transport assembly 1 1 may also be constructed of flexible materials and be of a sufficient length to reach target sites distant from the skin surface without the need for an open surgical procedure to enable the distal end (that end thereof that is furthest from the handle .1.2) of the biopsy device 10 to reach the targeted she.
  • the distal tubular coring and transport assembly 1 3. of the biopsy device 10 may extend distaliy from the handle 1,2 and. be configured to provide a distance sufficient to create a core of sufficient length for diagnosis and/or treatment purposes. As is described below, this distance of forward or distal projection ma be sel ecti vely changed at will, thanks to structure configured for that purpose, which may be built into or otherwise coupled to the present biopsy device 10.
  • Embodiments of the present biopsy device 10 may be used by right and/or left handed persons and in .multiple positions and orientations, so that in areas of limited access, the resent biopsy device may still be easily positioned tm idea! orientation to perform a biopsy procedure under real-time or oiher image guidance modality.
  • the entire device may be configured to be disposable or m y be configured to be reusable in whole or in part
  • Embodiments of the present biopsy device 10 may be electrically powered by oae or more batteries aad or external power sources through a simple electrical coupling to connect to an external power su ply conveniently placed, for example, in the handle -or proximal end of the present biopsy device as sh wn at element 637
  • the entire device may also be internally or externally manually powered, mechanically po wered or be powered by means such as compressed air, gas or pressurized fluid. Powering the excisional device entirely mechanically may be advantageous in areas in which the electric grid is absent, unavailable, or unreliable, in Fig.
  • the biopsy device 10 is shown in a pre- coring configuration with the scoopula-shaped distal end thereo open and i a configuration in which it partially projects forward from the proximal handle- 12 from its resting position with a portion of the beak element 13 extending slightly distally in closed configuratio along the first part of its forward excursion.
  • the biopsy device 10 is show with various illustrative switches to activate and/or physically move various internal components (not shown).
  • [ ⁇ 0681 Otoe embodiment is method of carrying out a breast biopsy.
  • Such a method may comprise imaging the tissue of the or gan (the breast, in this example) of interest and identifying the target lesion(s) or tissue to be removed or biopsied.
  • the skin may then be cleaned esing sterile techniques, the patient may he draped and anesthetics may be delivered,: in the case wherein the present biopsy device is configured for stereotactic operation, the present, biopsy device may be mounted to the stage of a stereotactic table.
  • the stage is used to fix the positio of the biopsy instrument, which may be electronically registered and tendered on a screen.
  • the generated electronic dat ay be used to position the device within the patient under computer assistance.
  • the ⁇ ⁇ coordinates of the target lesion from th initial images may be recorded I» y and 2 axes. Thereafter, once the biopsy device is attached, those dimensions are automatically keyed into the system and %, y and z axes are then calculated to aim the biopsy device (manually entered into the adjusting wheels of th stage) and the stage is cocked for firing or, according to embodiments, the internal firing mechanism of the device 10 is used in place of or in addition to the stereotactic table stage firing mechanism. Once the biopsy device is in place (after firing), a new set of images are taken with X-ray and the new target coordinates (i changed) are entered.
  • biopsies are generally taken abpu* the clock face", according to one embodiment.
  • “about the clock face 5 * generally means in. 6-12 space positions around the clock face (i,e,, 6 to 12 samples over a 360 degree sweep around the initial biopsy penetration axis). If short samples (shorter than, the length of the scooptda, for instance) are desired, th operator may manually part off the core sample at an length along the forward • movement of the cutting elements and continue to core forward or reset the coring assembly at its most rear-ward position. for further full length or short coring procedures.
  • the device may then be backed out with the stage controls (manually) and a postprocedure set of X-ray images may he taken to determine whether the target was partially or fully remo ved .
  • a photographic record ' may be take of the samples in the transfer magazine and/or a post procedure set of X -ray images m ay be taken of the removed samples to determine whether markers of the lesio (micro-calcifications in this instance) are- present in the retrieved samples.
  • a post procedure clip or marker may be placed in the biopsy site area to mark the location of the biopsy to enable a later precise identification of the location of the biopsy and the wound may be dressed and bandaged.
  • the distal tip of the biopsy device m3 ⁇ 4y be introduced through a nick/incision i the patienf s skin.
  • the present biopsy device may then be maneuvered into the desired position, using one of the penetration modes of the device.
  • a -further penetration mode of the present biopsy device may be activated, either with the stereotactic table's ow firing mechanism or the- depth controllable firing mechanism built into the present biopsy device or both, accordin to embodiments.
  • Such embodiments may specif that only the outer sheath and incorporated seoopu!a are actually tired through the lesion or the entire tubular coring and transport assembly may be fired fo ward together with the outer sheath and scoopula. i one embodiment, the scooputa may be fired to a specified distance less than its full travel capabilities. It. should he noted that the scoopuSa and any other elements, for example, a- guide, ma be fired, independently of any other element in any of these- penetration modes, or in otherwise maneuverin the device,, the seoopu!a- shape disial end of the outer sheath, of the biopsy device may be placed in proximit to or throug the target lesion.
  • the removable outer sheath may be similarly placed by itself through a. nic in the patient's ski to a position in. proximit to or through the target lesion, with or without a jig or fixture or holding device to fix i to the stereotactic table stage or manuall , at which point an optional delivery stage May then be initiated, to deliver, for exam le, the contents of a preloaded cartridge comprising, for example, tracer elements such a visible dyes, echo-enhancing materials and/or radioacti ve tracer elements.
  • tracer elements such a visible dyes, echo-enhancing materials and/or radioacti ve tracer elements.
  • the device 10 may be connected to the previous!) 1 placed removable outer sheath in order io deliver biologkaily-active substances such as Medications (such as epinephrine, for example) or anesthetics.
  • biologkaily-active substances such as Medications (such as epinephrine, for example) or anesthetics.
  • biol ogically-active substances may also be delivered, at any stage of the biopsy procedure , either directly through the open beaks, through the l i ving hinges of the closed beaks or vi a a reverse flo from the flush system built into the device *
  • the distal beak or beaks or work element 13 may then be opened and advanced along the scooputa- shaped distal portion of the outer sheath and may be caused to rotate to facilitate penetration through the tissue and coring.
  • the rotation and advancement of the distal beak or beaks 13 may be caused to stop just at or near the forward edge of the scoopula leaving, according to one embodiment no or substantially no dead space at the distal-niost tip of the present biopsy device that would otherwise be unavailable for sample acquisition, lite coring may then continue as • normally ⁇ encountered in stereotactic procedures, i.e., around the clock face but also laterally i an direction with the present device, and in either an aiitomatic or semiautomatic mode.
  • record stage may be acti vated to halt the corin stage just after the specimen has been paited-off in order to enable the practitioner to record image(s) of the shaft o scoojpula of the biops device in place in the lesion, and to record and document thai core samples in the transfer magazine 2? (particularl those of d rlerent cliosen lengths obtained serially during the procedure) were acquired precisely and sequentially from the previously-imaged, lesions.
  • the cor sample acquisition site may be firmly correlated with the image abnormality location
  • flO70j Another embodimen is another method of carrying out a biopsy.
  • a method ma comprise imaging the tissue of the organ (the breast, in this example) of interest and identifying the target lesion(s) or tissue to be removed or biopsied.
  • the skin may then be cleaned using sterile techniques, the patient may be draped and anesthetics may be deli vered, hi the case wherein the present biopsy device is configured to enable independent -forward firing of the outer sheath or seoopnla, the device may he infedneed through the skin, nick in the ⁇ re-fte' 5 loaded position mi mo ed i rwij with or without rotation to the nearest edge of an imaged lesion.
  • the operator would release the scoopuia to fire forward under the force of a spring or compressed gas, such as a CO2 cartridge for example, or manually., or by any other mechanical means, including pressurized fluids for example, or by electromechanical means.
  • a spring or compressed gas such as a CO2 cartridge for example
  • any other mechanical means including pressurized fluids for example, or by electromechanical means.
  • the scoopuia would enter the lesion center with little if ny residual shift: in tire lesion position, even if the lesion were to be of a firm nature (as in a beni gn fiteadenoma or a malignant carcinoma for example) and even if situate within very elastic fatty/fibrous tissue such, as exists in the majori ty of otherwise normal breast organs.
  • the scoopuia may be re-miaged for verification iloses and to precisely correlate the biopsy device position with respect to imaged abnormality. Additionally, the device may then be easily manipulated for fme-itsntog purposes if desired. Also, were me scoopuia to be fired to a position close to a nearb vulnerable structure (whether tissue or radiology backing plate or other), the operator may then be able to advance carefully the last few millimeters to the most optimal location. After these maneuvers and verifications have been completed, the target is now feed by virtue of title pinning stabilization effect of the scoopui component. This enables the operato to then, proceed with a number ' of options.
  • the operator may elect to deliver substances in a more pinpoint locationo using the scoopuia as a reference as well as a delivery pathway.
  • a radiation source could be introduced through the central !rnften, antibiotics and/or local anesthetic medications as well as coagulants- and/or ' vasoconstrictors may be introduced.
  • tracer elements to trace the pathway to sentinel node drainage may be introduced at this stage of tire procedure such that sufficient ti ted passes, while the rest of the biopsy procedure is completed to enable detection, in the sentinel node toward the end of or after the biopsy portion of the procedure has been completed.
  • Another option is to simpl proceed with multi-sample biops while taking cores "about the clock face" as previously described.
  • mat post-procedure elements may then be introduced via the distatiy placed (across the lesion that had been completely sampled or removed) scoo nia s precisely in the place of the biops a pling.
  • These elements could include implants such a cosmetic filler/delivery substances as well as other post-procedure devices that .may be introduced via the central himen/scoopula path ay, such as an.
  • the seoopula may be detached and left in place for oilier purposes or may optionally be removed together with the parent device and then the rocedure terminated in the usua, way with control of any bleeding, closure of the skin nick and the usual postprocedure dressingCs).
  • An embodiment of a biops device additionally includes an. independently movable or fixed . guiding .-element such as a stiff or floppy wire that may lead the way throug a natural surface plane or lumen -of a hollow body such as a duct, lymphatic space, blood vessel or other natural space or potential space.
  • a guiding element could be pre-placed and then elements of a biopsy device advanced over the guiding element
  • a guiding element may be fired forward in the same maimer as the scoopala described above, or it may simply be fixed near or at a forward (distal) position of elements of the biopsy device.
  • a guiding element could be coaxial with, in tandem with or adjacent to the long axis of elements of the biopsy device .
  • the guiding element could additionally , be a completely separate entity that ma be pre- placed by m operator skilled in imaging and targeting and feed-in place near or within the target tissue. After placement and fixation an operator may then proceed b advancing the biopsy instrument over the previously precisely placed and anchored guiding element.
  • Embodiments of the biopsy device may also be configured for imaging of the surrounding tissue during pre-operative, intraoperative, and/or post-operative phases of the device clinical use.
  • One embodiment for imaging integration may be implemented by insertion of a transducer or associated optical com en s for ultrasound imaging, direct visual imaging, or Optical Coherence Tomography (OCT), through the lumen of the biopsy device which may be carried out at any one or multiples of the aforementioned phases.
  • the transducer may be comprised of a single: element a phased array, or a stacked array and may be fixed or move is. rotation or translation relative to the scoopnla and may move with a beak(s).
  • Embodiments of the biopsy device might incorporate imaging transducers in parts of distal biopsy device subassemblies such as the distal portion of the outer sheath or scoopnla or as part of the beak.
  • Embodiments of the biopsy device could also use a lumen for free-space coupling of laser or broad spectrum ligh into and/or out of the tissue and may use tlie living hinge or a reflective component attached thereto to direct or steer the electromagnetic radiation.
  • the internal surfaces of tile tubes or seoopula may also act as reflectors or directors tor the light beam.
  • Embodiments of the biops de ice may also be configured to allow for ablation of tissue during fire-operative, intra-operative, and/or post-operative phases.
  • Ablation may be accomplished through one or more combinations of ' hyperfljermic ablation (such as radiofrequeacy, .microwave, laser, and ultrasound) and/or eryoahlation techniques.
  • the ablation sub-assembly may attain access through the central lumen of the biopsy de vice , m ay be an integral part, of the biopsy device, ot may connect to ot be inserted through a portion of the biopsy device that is left in the body providing appropriate access to the tissue site.
  • One embodiment may use radio frequency ablation techniques where parts of the seoopula or beaks are energized.
  • the relative rotation and or placement of the distal components of the biopsy -device may serve to selectively direct and/or focus the energy.
  • the sub-assemblies to accomplish this may be an integral pari of the biopsy device or may be insetted through the lumen of the biopsy device. These sub-assemblies may be configured to interact with elements of the distal seoopula to raise them into position needed for their function and these interactions may also enable them to perform a part of the biopsy procedure itself, such as forming a surface against which part-off may b accomplished .
  • Another embodiment may use microwave radiation ablation and may incorporate antennae elements into the beak, outer tube or seoopula or ma incorporate antennae elements i a sub-assembly that conk! be inserted through the centra! lumen o m close proximity to the axial length of the tubular coring and transport assembly 1.1.
  • the location of the antennae may be vari ed along the axial length of the open seoopula and may also be rotated, relati ve to the seoopula resulting in selectively directing the microwave energy.
  • electromagnetic reflectors could be built into the seoopula or other members and stacked or phased, arrays of antennae ma be employed to farther direct or dynamically tune the radiation pattern.
  • Auoiher embodiment may also use electron-beam ablatio an may incorporate a beam guide tube that may be inserted throngh-a lumen in the biopsy device t deliver the electron beam to selective locations in the tissue surrounding the device.
  • Another embodiment may use laser ablation and may deliver a»d direct the laser beam through an optical fiber or through a free-space coupled beam .
  • the beam or fiber may be directed by a reflective surface on or attached to the internal angle of the living binge and / or a reflective surface of the scoopuia. This may allow the bean to be directed in a pattern optimal for the desired ablation.
  • the laser ablation sub-assembly may use the central hi eii to deliver the light to the distal portion of the biopsy dev ice or may attach to an integral optical delivery system.
  • Another embodiment of the biopsy device may include a probe that provides cryosurgical ablation of tissue surrounding a cold probe that ma be inserted through- or be integral fo the biopsy device. The cold probe may repeatedly warm and rapidly cool die surrounding tissue resulting hi ablatioa. The probe may be positioned relative to the scoopuia such that the rotatable scoopuia provides a heat sink selectively shielding tissue from ablation.
  • specimen ultrasound or a radiograph may be carried out upon the specimens collected within the transfer magazine 27, which magazine may be specifically configured for echo- and radio- lueency as well as compatibility with MR! and/or other imaging technologies.
  • the removable transfer ma azine 27 may then be placed into receptacle that may be preloaded with preservative and sealed, if desired, a replacement transfer magazine 27 may then he loaded int the biops device to continue the biops procedure.
  • an adapter configured for the deli very of materials to the biopsy site ma be substituted for the transfer magazine 27 at an time.
  • the tissue transfer magazine 27 m y be -removed and replaced with an injectio cartridge that may be pre-loaded with post-biopsy elements such as medications, cosmetic implants, brachytherapy elements such as radio-active seeds, and or-a porous element loaded with a bio logical ly active substance and/or other .maferiais.
  • the biops device TO may be withdrawn- from the removable eater sheath, which oiiter sheath may then be used tor delivery of post-procedure materials to the target site while other components of the biopsy device may be packaged appropriatel and delivered to an appropriate laboratory for pathology/cytology analysis.
  • the outer sheath of the biopsy device may then be completely removed from the site and the wound dressed vising the customar standard of care procedures, if so attached to biopsy device 10 via an aspiration/material delivery port 639, hqtud aspirate storage vessel ma be removed from biops device 10 at any time and cappe securel for transport to as appropriate laboratory for cellular a»d subcellular analysis.
  • An liksiraiive placement of an aspiration/material delivery port 63 da biopsy device JO is shown in Fig. 1 herein *
  • Fig, 1 also shows illustrative placement of various external, controls, including a depth stop adjustment mechanism 630, a .forward firing trigger and lever 631 , a drive train earner bolt 63:2, a manual pan-off lever 633, and a cam clutch button 634, as well as other features such as a power switch/indicator 635, a DC power plug 637.. a flush port 638 and an aspiration/material deliver port 639, which will be discussed in more detail in further figures.
  • Hie placement of these exteniai controls is Illustrative in nature and embodiments may contain some or all of these controls in the locations shown in Fig. 1 or other locations,
  • FIG. 2 shows 8 distal end of a coring and transport assembl 11 of Pig. 1, with a configuration of a manually rotatable outer sheath 512, having a distal tip in the form of an edge-sharpened trough or seooptila.
  • tire coring and transport assembly 1.1 may comprise a rotating and longitttdinally movable (eg., selectably movable .in the distal and proximal directions-) articulable beak ⁇ or work element) 13, which may, in one embodiment be actuated by an internal helix 472,
  • a rotating and longitttdinally movable eg., selectably movable .in the distal and proximal directions-
  • articulable beak ⁇ or work element 13 may, in one embodiment be actuated by an internal helix 472
  • an internal helix 472 Although a single beak is shown and described this figure and some of the following figures, it is to be understood that more than one beak may be used in embodiments, and for that reason, whether only one beak, double beaks or multiple beaks are described herein, .all such embodiments are considered to be within the scope of this disclosure. If more than one beak is present, their individual shapes may be asymmetric to each .
  • a procedural option may be chosen where only the sedo ula-shaped distal portion, of the outer sheath may be exposed, and the work element may fee held in place at the proximal opening of the scoopuia.
  • the sharpened troitgh-like scoopu!a may be made to cut its way forward in the distal direction, with, little disturbance to the target lesion. Indeed, as th scooprik-shaped distal portion of the outer sheath presents a .nimfemssed.
  • the scoopuia-shaped distal portion of the outer sheath enables the device 1.0 to be advanced to or past the target lesion with a reduced chance of transporting potentially malignant, ceils or material through die lesion to otherwise healthy tissue.
  • a further advantage of optionally advancing only the trough shaped scoopula is that it.
  • the phrase '-scoopula-shaped distal portion of the outer sheath is intended to encompass a distal portio of the outer sheath that is shaped so as to present an ope portion or a iess-than full cross-section, as compared to more proxiraally-disposed portion(s) of the outer sheath 512,
  • the sides or edges of the distal soopuSa a be sharpened may be parallel to the long axis, or may be of varying profile with respect to the long axis.
  • the sklewails of the scoopula may be .gradually rising from its distal to proximal portions, enabling pre-seve mg of th tissue prior to engagement of the beak or beaks work element.
  • a beak or beaks work element by itself may sever tissue without the need to contact any surface of the scoopula, simply by nature of the shearing action and b virtue of exceeding the elastic limit of the tissue as tissue is f ced over the edges of the scoopula, With a distal scobpuia acting as a stabilizer and being anchored through the lesion, the work element (single beak, ultiple beaks etc) may then be made to move axially in a distal direction and, accordin to one embodiment, unde rotation.
  • a beak or beaks work element by itself may sever tissue without ' the need to contact any surface of the .scoopuia, simply by nature of the shearing action and by virtue of exceeding the elastic limit of the tissue as tissue is forced over the edges of the scoopuia.
  • f ig. 2 shows the coring beak disposed distally almost all the way forward to its part-off point and rotated slightl as it would be seen, as a snapshot of its continuous forward travel whil e rotating, coring, and then eventually partin off as it reaches the end of the scoopuia.
  • the coring beak may then be configured to part-off die cored sample by closing down against the inside diameter of the scoopuia *
  • the work element may be configured to withdraw under rotation or not back to its initial position (according t one embodiment, adjacen to the proximal opening of the scoopuia), thereby transferring the parted- off sample proximaliy to an internal transport, mechanism and continuing to a transfer magazine 27 (not shown).
  • such internal transport may be carried out by a rotating helix or helices 472 disposed in the central lumen of the de vice. It should be rioted that th centrally-disposed helix 47 shown in Fig. 2 is but one possible mechanism to rotate the beak elements) 13 and to transport par-ted-off cored samples in the proximal direction, and embodiments are not to be limited thereby.
  • the perator allows full forward travel of the work eSement(s 1 % there will be no or substantially no distal ti dead s ace* i.e., the device will sample (e.g..,. core) nil the way to or substantially to the distal-most tip of the scoopuia within or past the lesion., as originally placed.
  • This tack of dead space allows optimal placement of the exeisional device 0 in relation to physical structures such as the chest wall, radiology backing imaging plates or other structures associated with either the bod or the supporting device . , such as a stereotactic table.
  • either the device itself, in one embodiment, or the outer sheath, in one embodiment, may then, be rotated, "around, the clock" such that the open portion of the scoopuia faces the next desired clock face positio and coring may begin again, repeating as ofte as desired, selectively f3 ⁇ 4il
  • the clock may then, be rotated, "around, the clock” such that the open portion of the scoopuia faces the next desired clock face positio and coring may begin again, repeating as ofte as desired, selectively f3 ⁇ 4il
  • portion of the outer sheath 512 may also be useful next: to sensitive structures in general and In cardiovascular applications is particular. It should, be noted that the scoopula and i t coixesponding work element may be of any length necessary to .match a particular tissue,, target lesion, and/or site, according to embodiments.
  • an internal helix 472 may be configured to provide the axial force that is necessary to open and close the beak(s) against me scoopula for tissue part- off and retrieval and transport.
  • a helical element 472 and first articulable beak element 13 may be configured to rotate at a -rotation rate of between, for example, 0 to about 10,000 rpm.
  • a rotation rate of between about 3 ,000 and 7,000 ' rpm may be- selected for parts of procedure.
  • a dither or slight jittering of the articulable beak elements may h implemented in place of or imposed on to of the rotation *
  • a rotation rate of about 5,000 rpm (phis or minus about 20%) during at least one phase of the tissue coring and excision process.
  • a helical element 472 may define a single-coil configuration.
  • the helical element or elements may be provided with structure configured to increase its- column strength and torque and to decrease the torsional deformation thereof.
  • such a first helical element 472 may comprise a two or three (or more) coil, structures.
  • these coils may decrease the tendency of a helical element 472 to compress, may increase the torq e that it may apply against the tissue through trie first or first and second articulable beaks and may increase its resistance to deformation as it is rotated. Such configuration may also spread the torqu load to multiple points of attachment with the first ' and/or first and second or mul tiple articulable beaks,
  • FIG. 4 illustrates the same components of Fig. 3. but in a different snapshot
  • Fig. 5 illustrates the same components of Figs. 2-4, but in this case, the operator has chosen to manually part-off the sample before the beak element 13 has reached th distal end of the scoopula portio of an outer sheath 512, an operation made possible by the drive • mechanism of one embodiment of this device, as is described below in later figures.
  • the beak element 13 in such an embodiment ma also comprise a living hinge 458.
  • a living hinge 458 may comprise an H-shaped series of stress-relieving kerfs and relieving features at the ends of the kerf cuts, allowing the beak element to close against any portion of the scoopula.
  • These stress-relieving kerfs may reduce the stress induced in the living hinge 458 to a non-inclusive range, for example of 10 to 360 ksi (kips per square inch).
  • These elements of a living hinge 458 may -also, according to embodiments, serve- as conduits for. medications (anesthetics and epinephrine, for example) and other liquids, such as saline flushes.
  • Such conduits enable such fluids to flow through the centra! hinie of the device 10 for delivery to the distal end thereof even if the beak ⁇ s) may be closed during such an inim-opemtive procedure.
  • FIG. 6 is a side view of the com onents of Figs, 2-5, In this Mhtsitation, a more typical part-off point i show-n with the toward edges of a trough-shaped scoopula beak and the active beak perfectly or near- erfectly opposed, eliminating all or substantially all dead space at th distal end of the device.
  • One beak attachment tab is shown interacting with the distal end of a helical element 472,
  • FIG. 7 shows a view of a variant of e distal end of the device, according to one embodiment, that comprises an extended collar on a single beak assembly 13 revealed where the outer tubular element 5 2 is cut away to reveal the attachment point of the extended collar wit a helical Inner tubular element 4 ⁇ 73 ⁇ 4 ⁇ as shown ; Fig, 6.
  • This variant provides greater stability in the trough-shaped scoopul sections of travel of the inner coring, cutting, transport and part-off active portion of the device and enables high-speed spinning of the active beak element daring coring, while protecting the tissue sample from being exposed to high speed helical motion until it has the opporiiuhty to move along the helical portion, a la!ly after being fully parted off from the host tissue. Details of active beak .attachment are not shown i n this ill ustration.
  • Fig, 8 show details of a single distal active beak 13 attachment to elements of a split collar using torsion bar 13 A and bands 13B to aeconmiodate the transfer of forces needed • to open, close, and stabilize the acti ve beak element 13 P according to one embodiment.
  • the bands 13B move proxinially causing the beak 13 to close, as shown later n Fig. 11.
  • attachmenis may.
  • Such split collar extension may be configured to have a straight longitudinal split, i one embodiment, or a curved split wit respect to the long axis of the device, in other embodiments.
  • Such a curved: split wit h r espect to the long axis of the de vice will impart: twisting of the beak or beaks as they close down, which May aid in part off, particularly if the twist is in the opposite direction of the beak assembly rotation.
  • the outer sheath 512 is not shown, in this view.
  • Fig, 9 shows the same configuration as in Fig. 8 ab «ve 5 but m. a snapshot position showing a scissors-like spring-jaws action of a beak against th scoopuia portion of the outer sheat 512, which is shown in this view.
  • Such spring-jaws action is enabled by opening the single beak, in this illustration, more than it would be if the . back of the beak 13 remained parallel with the extended collar to which it is attached, or effectively over center.:
  • the torsion bar 13 A attached to the proximal end of the beak and tlie distal end of the upper half 13C of the split, collar to which the beak; is attached is shown being flexed in.
  • tipper collar half 13C and thus an axial oscillation action, between lower and upper halves of an extended collar section, which may tend to move the severed ti ssue specimen axiaily in a proximal direction.
  • inner elements such as scales etched or ground into the inner diameter of a split collar are added to such an embodiment to take advantage of the axial tissue specimen movement gained by this repeated back and forth, action, a ratcheting .mechanism to aid delivery of tissue to a transport section of the device may be created.
  • Other inner wall treatments such as rifling, among such treatments, may a so be added to aid in the transport of the cored and paried-off tissue samples in the proximal direction.
  • ig. 1:0 show an active beak nearly completing its fo ced compliance with the inner diameter of a trough-shaped, scoopuia of an outer sheadi. element during a, snapshot in. time of its rotation/forward movement, it sho ld be noted that sharp edges of an mtef sheath scoopuk 512 as sbiiwh may be beveled either externally or intetmliy, according to .era odxrae-a s.
  • Fig, 11 shows the same components of Figs.
  • hot OW showing an active single beak in close apposition with the forward edges of the seoopnla section of an outer sheath 512.
  • This illustration shows another embodiment of the shape of the edges of a trough or scoQpuia section, which particularl if enabled to be oscillating, may aid in coring and thus facilttate the distal advancement of an entire distal portion of the biopsy device at the initial stages of the procedure.
  • the edges of the scoopula may also he asymmetrical at any point relative to any other point, according to embodiments.
  • Fig. 12 shows the same components as are shown in Figs. 9, 10 and i 1 , but from a top view perspecti ve, This view shows a torsion bar 13 A m close proximity to the proximal portion or base of an active beak 13 with respect to the tipper half 13C of an extended collar portion of an active beak assembly, according to one embodiment Various methods of attachment, of a torsion bar to the base of a beak 13 may be envisioned, and are not specifically described herein.
  • FIG. 13 shows the- embodiment of fig, 2, viewed facing the distal end.
  • 1.3 shows an exaggerated beak opening for illustrative purposes. Couplings are shown mechanically linki ng a helical element 472 and the prox ima l portion of a mo veab le beak 13. Other couplin arrangements that couple a tivhnlar coring: and transport assembly (pr 5 simply, the proximal end of the device) ar possible and fall wit a the scope of this disclosure-. Again, sharpened be vels of an outer sheath 512 and a beak 13 may be internal or external or opposite to one another,
  • a sh ws the configuration of a tubular transport and coring assembly
  • I t of Fig. showing forced, compliance cycling of an active beak element 13 with the inside diameter of the scoopula portion of a outer sheath 512, according to one embodiment.
  • the beak was opened over center, as ai Fig. 13, and as roiation occurs, the beak must move back to a fully opened, but not o ver center positi on, eventually as a Straight extension of a helical element 472, until it moves past the opposite edge of outer sheath 512's scoopnla and then can again, ope slightly over center.
  • f#091f Fig, 14B shows the ' features- f co nents -of Fig.
  • IM 21 Fig, 15A is a perspective view of a split-tube single beak assembly 13 In retracte position against an outer sheath 512 that terminates in a seoopu1 ⁇ 4 Shown in this view is a living hinge 458, which attaches a distal beak to an upper half 13C (Fig. ISB) of a split tube aid which allows the beak 13 to close dow against the inside diameter of a seoopu!a 512 of an outer sheath, as will be shown and described in later figures.
  • Element 458 may be considered to be similar in function to the torsion bar 13. A described relative to the previous Fig. 8 above.
  • the ac tio of li ving hinge 458 provides positive attachment to both the distal tip of a beak assembl y 13 as well as the upper half 13C of a split tube.
  • the spl it tube may be similar in nature to a split collar upper half 13C and lower half 130 previously described, albeit longer than a split collar.
  • the split tube may be of s ch a length as to be coupled directl to its own rotational and axial drive -mechanism withiu a handle 12 of the biopsy device, to allow beak actuation and rotation.
  • Pig: l.SB is a perspective view of a spirt-tube single beak assembly extending partly out of an outer sheath, with a beak open over-center arid, selectively under rotation about longitudinal axis 14 o not.
  • the beak(s) 13 may also be configured to move substantially parallel to this longitudinal axis 1 , as the beak(s) 13 move from a retracted position to a pattingK>ff position in which the distal tip of beak 13 extends substantially to the distal tip of outer sheath 512, to thereby achieve substantially zero dead space.
  • the over- center action of the beak is due to an attachment of two beak opening and closin tendons 468 formed with a beak .-(one on either side) and the lower half of a split ⁇ ube 5 shown as element 13D in this view.-
  • the upper half of a spli tube 1.3C may be attached to the proximal end of a Jiving hinge 458.
  • Tube actuates a beak 13 to open and close.
  • Such axial movement may be limited, in embodiments, by a T-shaped or otherwise shaped tab that may be formed as part of a lower tube half 13D sliding within a travel limitin slot 467 in an upper half 13C of split tube, accordin to one embodiment or opposite In other embodiments, as well as being o any shape. Sev eral of these tabs and slots may be arranged along the length of a split tube, and th split tube, beak., l iving hinge and tendons may be ferned of a single tube tha may be, for example laser cut Additionally* the slot(s ⁇ 46?
  • this may allow flush fluids drawn between, an. oute sheath 512 and a split tube to selectively pass nto die central lumen of a split tube to aid m tissue specimen transport.
  • a single axially split tube may have more than one beak., configured with a .movable beak attached to die upper half DC of a split tube wi th a living hinge and tendons, as described above, and fixed beak as a distal extension of the lower half 13D of the split tube, ieerne distal to the attachment points of the proximal ends of the tendons as an extension of the knver half 13D, Such a fixed beak in.
  • the So were half .13D may be thought of as a short scoopnla mimicking that of the outer sheath 512, but shorter., and in fact reaching distai!y only .to the point where the .movable beak would close down against it
  • the beak assemb ly would be capable of both coring and parting off a tissue spec imen beyond the end of the outer ⁇ sheath 512 scoopula, if desired.
  • This embodiment is not illustrated, but may be easil envisioned by imagining that the split tube beak assembly of Fig. 15B had an extended fixed beak as part of the lower half 13D of the split tube. Under rotation, ei ther a split tube single beak embodiment or a split tube doubl e beak embodiment will part off a tissue specimen if the movable beak moves to at least the longitudinal axi 1 of Fig, 15B.
  • Fig, 15B also shows that at least the outer sheath 512 may be rotated, as suggested at 16. n so doing, the sharpened edge of the open scoopula- shaped distal portion of the outer sheath.512 cuts through an arc of tissue.
  • the arc of tissue along 16 may be oriented substantially normal to the long axis 17 of the tissue specimen 18, That is, according to one embodiment, the open scoopula-shaped distal portio of the outer sheath 512 may be rotated about its longitudinal axis (e.g., 14 in Fig, 158), which is normal to the long axis I ? of the tissue specimen 18.
  • the specimen 18 may (but need not) be shaped like a shori segment of a tube, with tapered 3 ⁇ 4i ! and distal ends.
  • further tissue specimens may be cut from the tissue then facing the open scoopula-shaped distal portion of the just-rotated outer sheath 51.2, which lacing tissue may be radially separated from the tissue from which the previous, pre-rotation specimen was cut. After rotating the open scoopula-shaped distal portion of the outer sheath.
  • a radially- directed force may be imparte on the biops device, to cause tissue to prolapse into the scoopula- shaped distal portion or to increase the amount of tissue that prolapses therein,: This may increase the qualit of the tissue specimen, depending upom for example, the type and arehkectute of the tissue being cut
  • FIG. 15C is a perspective view of a pllt-tobe single beak assembly in. full extended position at the end of the seoopnla of an outer sheath, which position is suitable for part-off of a tissue specimen and tor other pur oses, including penenation to a target tissue site or fepositioning to a second target site, according to embodiments.
  • M tt n ' g tab may be seen, in this view.
  • entir device 1.0 for purposes of illustrating its enabling mechanisms, which ma comprise a distal end consisting of an outer sheath, an inner or distal sheath, a proximal sheath, work elemen or elements and such features as first, second and third helical elements, i any combination, as well as other elements such as suggested by Fig. I or previous .figures and as detailed further below.
  • the description below begins at the distal end and continues to the proximal end of the device 10, and embodiments ' may include any or all of these elements, according to individual, enibodloienis.
  • a first or, according to some embodiments, a first and second (or more) articulable beaks 13 may comprise one or more slots 461 defined therein to form a living hinge or hinges 458,
  • slots 461 may have lengths ranging iton-inclusively from 0.050 inches to 0.500 inches.
  • the separation between adjacent slots 461 may also be in the range o 0.005 inches to 0.050 inches or up to 2/3 of the distal tube internal diameter.
  • the thickness of living hinge 458 may be different in thickness than that of the surrounding material and may be in the range of 0.001 inches to 0:015 inches.
  • the range of motion of the living hinges 458 may be ftem 5 degrees t 75 degrees with respect to the longi udinal axis of the outer sheath. 512.
  • Living hinges 458 could be fabricated from currently existing alloys such as a stainless steel, for example, 304, 31 or 0* In different tempers or work hardened states* nickel titanium alloys, maraglng steel, composite materials such as made from fibers, for example, carbon fiber, and/or .future high ductility alloys.
  • each of a first arid second articulable beak tips 452, 454 may define or ma be coupled to a first tendon 468 coupled to one side of the first articulable beak and a second tendon 470 coupled to the other side of the first articulable beak.
  • a single tendon .may b defined or multiple tendons may be defined Additionally, these tendons may be defined at different relative angles to each other to impose an unequal or asymmetrical force to the sides of the distal end of an articulable beak tip 452 or 454, i embodiments.
  • first and second tendons 468, 70 may be configured to selectively apply proximaliy-directed force and a distally-directed force to the distal portion of an articulable beak to cause the first and second articulable beak tips 452, 454 to assume their closed and progressively open configurations,, respectively, or in the case of a single beak configuration, to open or close at some ⁇ which may be eser-seiectable) point along a scoopula of an outer sheath (as shown in Fig, 1.6B).
  • first and second tendons 468, 470 pulling on the first and second tendons 468, 470 by proximal force acting on an actuating element 469 tends to close the first and second articulable beak tips 452, 45 (i.e., draw the respective distal tips closer to the longitudinal axis and closer to one another) and pushing on the first and second tendons 468, 470 tends to open the first and second articulable beak tips 452, 454 (i.e., draw the respective distal tips away from the longitudinal axis and away from one another ).
  • Tendons 468, 470 may be fabricated using the same engineering principles* concepts and material considerations as for the living hinge 458» Geometr of the tendons ma be designed to ensure the ail closure stress levels be kept in the 10 ksl to 360 ksi range.
  • the width arid height of the tendon element ma have non-square and/or non-constant cross sections, as elliptical for example, in the range of 0,000$ inch to 0.015 inch on a side.
  • the lengths of the tendon flexures could be in the range of 0.025 inches to 0.500 inches,
  • FIG. 16B shows a work element ⁇ shown as cutting elements 13 in the embodiment of Fig. 1 ⁇ comprising, in one embodiment, twin articulable beaks 516 and 518 (numbered, differently is this illustration to indicate that the entire beak ot beaks may be comprised of many features already outlined in Fig. 16 A) and outer sheath 512 of an excisional device according to one enibodinieut.
  • an excisional device may comprise an outer sheat 51:2 defining a longitudinal, axis whose distal end, as shown, may comprise a seoopul (seen rom the to down and shortened in this view, not necessarily to scale), trough or otherJeadmg edge s a e, According to one. embodiment, the distal edge or edges of such seoopula, trough or other distal feature may he sharpened at least partially around its circumference- and side edges as desired.
  • a work element may be configured to at least partially fit within an.
  • outer sheath 512 may he configured t be withdrawn in the proximal direction into an outer sheath 532 and extend out in the distal direction at or near the end of the distal free end of a seoopula while lying within ts curvature *
  • the work element may comprise a single beak (518, although 516 conid be chosen as well since the • work element rotates and such a single beak m act against the seoopula portion of the outer sheath 512 as shown m Figs, 2-15 above),
  • a beak 518 or 5.16 may be configured, including: by Its shape, according to one embodiment to close against the in side diameter of a seoopula at any point along its length, as shown in previous figures, as well a the distal-most edge of the seoopula, which shape may be similar to beak(s ⁇ .
  • the beakf s may be configured to rotate within an outer sheath 512 about the longitudinal axis thereof
  • a first and/or first and second articulable beaks 516, 538 may define respective first and second curved distal surfaces configured to cut tissue.
  • the work element may he further configured to be advanced distally such that at least a first and second curved distal surfaces of a beak or first and second articulable beaks 516, 518 are at least, partially disposed outside of a distal outer sheath (not shown in Fig. I6B).
  • a portion of both of the first and second curved surfaces of a single beak or of the first and second articulable beaks 516, 518 may be configured to rotate at- least partially outside of an outer sheath 512- wim the remaining portions ' thereof configured to rotate within an outer sheath 512.
  • articulable beaks 516, 518 may be configured to- rotate within an outer sheath 512, This configuration radially supports a first and second articulable beaks 516, 518, and prevents them from over-extending or otherwise undesirably deforming when cutting through tough tissue.
  • a shearing or scissors action may be imparted, as the distal tips of a first and second articulable beaks 516, 518 rotate inside the extremity of an outer sheath 512 and act with their sharpened edges against: die side edges of an outer differentially or non-rotating sheath 512 as previousl described * According to one embodiment, the shearing or scissors action, occurs between the distal portions of a first a d/or second articulable beaks 51 , 518 against edges of a seoopula portion of an outer sheath 512. However, the first and second articulable beaks 516,
  • the distal f ee end of an outer sheath 512 may be shaped as desired and may comprise., as shown in Fig. l$ i a. seoopula (or a. trowel- or trough-like, for example) shape. This distal edge may be shar ened ⁇ to aid in the penetration into and coring of tissue. Vacuum slots may he provided -within an outer sheath, as shown at 520. Should a vacuum he drawn within the lumen of an outer sheath 5.12, surrounding tissue may be drawn thereto, thereby assisting in stabil izing the distal end of the exeisional device during the specimen cutting procedure.
  • Vacuum slots 520 may also serve to collect liquids and f e cells fro the surrounding tissue or to deliver liquids to the surrounding tissue. They may also serve as an opening at the dis tal end of the device so that as vaeunr is applied Internally at the prcmlrnal end. of an outer sheath 512 as n aid in tra sporting tissu specimens pro imally, a corresponding vacuum is not built u behind (distall to) the tissue ⁇ ecimens. Avoidance of vacuum buildup distal, to the tissue specimens may facilitate tissue transport ' in. the proximal direction as well as prevent tissue specimens from acting as plugs in the work element Slots may also be provided in. the trough of a scoopula itself as an. aid to imagin devices to sharpen visibility of a scoopula in relation to siuTounding tissues.
  • the shape of the sharp cutting elements beak (or work) assembly 1.3 provides substantial support for all movements required of the cutting beaks daring rotation, opening/closing and axial motions not sho n * ti ing the nomerselature of Fig. I in particular, this mbodin1 ⁇ 2iit enables the sharp cutting elements of beak assembly 13 to be made exireniely thin, which fulfills a requirement that for an gi v en outer i3 ⁇ 4dial dimension of a tabular coring and transport assembly (including the cutting beak assembly) 1 1 (see also Fig.
  • the caliber of the core sample retrieved from the patient will be as large as possible.
  • the shape(s) of the sharp cutting elements of beak assembly 13 specified for use in coring and part-off according to embodiments enable the biopsy device 10 to core & foil diameter, and in fact larger than full diameter with respect to the dimensions of th coring and transport assembly 1.1 :S f which slightly larger caliber (e.g.,, diameter) ma be desirable in order to compress, "stuff', or pack in as muc tissue sample into the tubular coring and transport assem ly .11 as possible, which may prove advantageous from several standpoints (including diagnostic, clinical standpoints) or provide more sample (not shown) for analysis,
  • a work element 13 of Fig, ,1 including articulable .beak(s 516 and 518, or 516 or 518 alone of Fig, J6TL ma be configured for rotation within an outer non- or differentially-rotating outer sheath(s), such as 512 of Fig, 1 B, oreo er, the articula le beafc(s), according to one enibodinient :! may comprise a surface having substantially the same curvature as me body portion of the work elemen 13.
  • the body portion of the work element may be that portion thereof that is proximal- to the articulable beak or beaks
  • the articulable head ' s) may be generally described as- being r com r sing - one ' - or more hyperbolic segments of one o more sections of a hollow cylinder, such as a hypo tube. Variations including complex curves may be incorporated into the shape of articulable beak(s) to optimize function in different sections of, for example, the edges of the articulable beaks.
  • first: and second articulable beaks may have slightly different shapes from one another.
  • the angle .formed by the distal portion of first and second articulable beaks or between a single articulable beak and a scoopula may be, for example:, from about 5 to 75 degrees. According to one eumodhiient, the angle m y he between about 10 and: 30 degrees. According to another embodiment the angle formed by tire distal portion of first and second articulable beaks or first beak and a seoopula may be about I S degrees.
  • the entire work element, inchidiiig a first or first and second articulable beaks .16 ' and 518 of beak assembly 13 along with first and second tendons, beak actuation mechanisms such as 469, l i ving hinges 458 (as best shown i Figs.
  • a first helical, element may ail together comprise a single monolithic structure formed of a same material thai may be (e.g., laser-) cut from, for example, a single solid hypo tube. That is, these structures- .may be formed together of a same pi ece of unbroken homogeneou s material whether a single split tube i s selected or whether a non-split tube is .selected* according to embodiments.
  • Such a monolithic structure may be considered to be a monolithic work assembly, and may take the form of a monolithic beak assembly, which is but one embodiment thereof.
  • Flas. 17A and 17B show an intermediate., proximal sheath 540 of an exeisiaual dev ce 10,: according to one embodiment, ithou showing any additional non- or difiere ially-rotating distal and outer sheaths.
  • a proximal sheath 540 may be configured to fit over at least a. portion of a work element 13 (as shown later i Fig.
  • a proximal sheath 540 may be configured to resiiienil bias a first and second articulable beak 518 or beaks 516 and SIS, if twin (or multiple) beaks are used, in the open position.
  • a proximal sheath 540 ma he slid over the proximal portion of a work element 13 and then further advanced over the work element 13 until the distal end of the proximal sheath 540 abuts agains a, collar .542: (or shoulder 593 of Fig, 20), Therefore, as will be described below relative to Fig. 21 , selectively acting upon (e. g.., exerting a proximaily- directed or distafly-directed. force on) the proximal portion 548 of a proxi mal sheath 540 causes a first and second articulable beak 516, 51 S to open and close.
  • a proximal sheath may act in concert wit a distal sheath 590, as shown i Fig.
  • the ⁇ proximal sheath 540 may be either free Soaring or driven in rotation, and may be noa- or differential i rotating, with respect to any outer sheaths as described tether on.
  • collar 542,. which is primarily shown for illustrative purposes, may be eliminated and a beak actuating portion 469, as shown in Fig, 16, and a body portion 428, as shown m Fig.
  • a proximal sheath 540 may be directly attached to a proximal sheath 540 at the distal and proximal ends of a helical portio 544 of the proximal sheath, in such an embodiment, the work element 13 may be attached, to a proximal end of such a second helical element 544 to rotate the work element 13, including a first and second articulable beaks.
  • a proximal sheath 540 may be configured to entrain the work element 13 in rotation as well as to open and close articulable beaks.
  • a first helical element 472. such as previously show in Figs, 2-6, may be decoupled from the work element.
  • proximal sheath 540 may comprise such a second helical element 544.
  • the present biopsy device comprise a first or a first and second helical elements, but such helical elements may be eo-axiali arranged within the device, one over the other.
  • at least a portion of a second helical element may fit over a first helical element within the biopsy device to effectively define a stracture comprising a coil-within-a-coil, as shown in Fig. 19,
  • a proximal sheath 540 may comprise a proximal region 548 and a distal region 546 comprising a second helical element 544.
  • the proximal region 548 may be generally co-extensive with at least a portion of a first helical element 472, if included in such embodiment, of the work element and may comprise stracture configured to aid in the proximal transport of a severed tissue specimen, indeed, after being severed from surrounding tissue, the cored specimen will be urged i the proximal directio within the body portion of the work demerit ⁇ 3 and eventually engage such a rotating first helical element, if used, or engage a flush conduit that aids tissue transport.
  • a first helical element may assist In the transport of the cored specimen to, e.g., a tissue collection transfer magazine 27 coupled t the present biopsy device.
  • Surface features may be provided on the inner lumen of a proximal sheath 540 which, however configured, m y aid in the transport of cored specimen by providin some measure : of friction between the cored specimen and a rotating first helical elemen t 472, if used, to enable the cored spec ime to move i a proximal direction through the device.
  • tissue entrained by a first helical element illustrated by 582 of Figs, 19 and 22, will als be drawn against the inner lumen of a proximal sheath 540.
  • a flush and a vacuum may be drawn within at least a proximal sheath.540,
  • cored tissue specimen(s) may be drawn through the coils of a first helical element, if present, to come into intimate contact with the (e.g., patterned or slotted) surface of a proximal sheath's inner lumen.
  • flush fluid and vacuum acting in concert but with out a first helical element, may suffice to ensure tissue specimen transport to a transfer magazine.
  • the flush may be provided with, flow rates ranging from 0 to 100 cubic centimeters per minute.
  • the vacuum may be provided with a pressure range from atmospheric to ' 0:001 Tort and may have flow rates rangin from 0 to 200 cubic centime ters per minute,
  • a proximal sheath As shown in Fig. 17A, and according to one embodiment, a proximal sheath
  • a proximal sheath 540 may define one or more elongated slots 552 therein.
  • Fig. IB shows a proximal sheath 540 comprising a plurality of elongated slots 552 disposed in a spiral pattern a ound a longitudinal axis and serving as a helical element, according t one embodiment
  • Such slots 552 may allow fluid communication with the interior lumen of a proximal sheath 540.
  • a slot or slots 552 may go all of the way through the wail thickness of a proximal sheath 540.
  • slots 552 may also serve as conduits for flushing liqui s used to aid teansporS:: m concert with aspiratio applied from a vacuum source within or external to the device 10.
  • slots 552 may be seriall disposed end-to-end substantially parallel to the longitudinal axis of a proximal sheath 540, as shown iti Fig.
  • 17 A may he offset relative to one another, or may be disposed in a spiral pattern, whether non-overlapping o overlapping, as shown in Fig, I S,, thus effectively acting as a elongated co-axially disposed third helical element of similar or different pitch than a second helical element similar to that discussed -under Fi , 17B above *
  • Fig, 18 shows one embodiment where a proximal sheath 540 includes slots
  • slots 552 may be effectivel ina tion as a third helical element co-axially disposed relative to first helical element 582 and second helical element 544.
  • the slots 552, according to one embodiment, may he configured to provide Resistance to the cored tissue specimen to enable a first helical element to transport the tissue specimen in the proximal direction. It is recalled that a first helical element ma foe decoupled from the work element.
  • the relati ve speeds of rotation of a first or first and second articulable beaks and a first helical element may be driven independeeti and differentially tuned to optimize both tissue coring and tissue specimen axial transport in proximal direction (e.g. to transfer magazine 27 of a device 10).
  • i I OS Fig , 1 shows details of a proximal sheath, beak actuatio elements and a inner first helical element, according to embodiments, it is to he noted that the figures herein are not t scale and the relati ve dimensions of the constituent elements of the biopsy device 10 may vary front figure to figure.
  • the working end (e.g., substantially all structures distal to the handle 12) of the biopsy device -10 may be essentially composed or formed of two or more separate elements that, are disposed substantially concentrically or co-axially relative to one another. This results m a .mechanically robust working end of the excisional device that is economical to manufacture and to assemble . As shown in the exploded view of Fig.
  • one embodiment comprises a work element thai comprises 8 body portion 428 and tendon actuating elements 469 (only one of which is shown in this view), and may be terminated by a fif stand/or second articulable beaks (not shown in this view),
  • a first helical .element 582 may be formed of the same material as the work element 13,
  • the work ement 13 i.e., a body portion 428, a tendon actuation element 469 and a first or first and second ⁇ articulable beaks
  • a first helical element may be cot of f rmed from a single piece of material, such as a hyp tube.
  • the hypo tube may be suitably (e.g., laser) cut to form the bod portion 428, the tendon actuation elements 4( 9, the first and second articulable beaks as well as a first helical element 582, A first helical element 582 may then be .mechanically decoupled from the work element 13 by cutting the two structures apart These two structures are, therefore, labeled (la) and (lb) in Fig. 19, to suggest thai they may have been originall formed of a single piece of material.
  • a first helical element is mechanically decoupled from the work element 13 enables the rotation of a first helical element 582 to be independent of the rotation of the work element 13,
  • a first helical element 582 may rotate at a comparatively slower rate flmn the rate of rotation of the work element 3, as transport of a severed tissue specime may not retpire the same rate of rotation as may be advisable for the work element 13.
  • a first helical element 582 may be deleted, leaving an expansion chamber in its place, relative to die central lumen inside a proximal sheath.
  • a proximal sheath 540 (not shown in this figure ⁇ , since the diameter of a proximal sheath 540 is greater than the diameter of the beak assembly 1.3 to which it may be fixed, thus providing an expansion chamber pto imal. to the roximal end of the beak assembly 13.
  • a prox imal sheat could extend proximaliy to a transfer magazine 27 at a vacuum tight junction, full 1
  • the second of the three main separate elements of the working end of the biops device is aproximal. sheath 584, as shown at (2) in Fig. 19, A proximal sheath 584 ma comprise, near its distal end, a second helical element 585 (similar to 544 of Fig, .18).
  • a second helical element 585 may be dispose concentrically over a portion of & first helical element 582.
  • a proximal sheath 584 may comprise one or more proximal locations 586 and one or more distal locations 587.
  • the proximal and distal locations 586, 587 may define, for example, indentations., obrounds or through holes and may indicate the position of, for example, spot welds (or other artacint!eni modalities) that are configured to mechanicall couple a proximal sheath 584 with the work element of the biopsy device.
  • a proximal sheat 584 When assembled, a proximal sheat 584 may be concentrically disposed over a Irst helical element 582, if present in such embodiment, nd ' advanced such that the one or more proximal locations 586 on a proximal sheath 584 are aligned with corresponding one or more proximal attachment locations 588, if preseot, o the work ⁇ element 13 and such that one or more distal location 587 on a proximal sheath 584 is aligned with corresponding one or more distal attachment location 58 on a tendon actuating element 469.
  • the corresponding locations 586, 588 and 587, 589 roa then be attached to one another- For example ⁇ one or more proximal locations 586 on the proximal sheath 584 ma b spot-welded to corresponding on Or more proximal attachment locations 588 on the work. element 13 and one or more distal location 587 o the proximal sheath 584 may be spot -welded to corresponding one or more distal attachment location 539 on a tendon actuating elements 469.
  • locations 5S6 S 587, 588 and 589 are only shown in the figures as illustrative, and exemplar only, as there are many ways of mechanically coupling or attaching a proximal sheath 584 to the work element 13, as those of skill may recognize.
  • a proximal sheath 584 may he attached uch that movement of a second helical element 585 (e.g,, extension and compression) correspondingly actuates a first beak (and, if present * a second articulable beak) between a first (e.g., open) configuration and a second (e.g., closed) configuration.
  • a second helical element 585 e.g, extension and compression
  • a proximal sheath 584 may be mechanicall coupled to the work element of the biopsy device such that, for example, a proximal portion thereof (e,g. , at o in the vicinit of proximal locations 586) is attached to a body portion 428 of the work element 13 and suc that a distal portion thereof (e.g., at or in the vicinity of distal location 587) may be attached to a tendon actiiating elements 469.
  • compression and extension of the second helical -element 585 may cause a. relative displacement of a tend n ⁇ actuation, elements 469. and a body portion 428 (i.e.. one may mow while the other is immobile or substantially so 3 ⁇ 4 or both may move relative to one another), thereby causing the actuation of a first or first and second articulable eaks,
  • Fig. 20 shows a son-, differentially, o same-speed rotating distal sheath
  • Th third (labed as 3 in thi s figure as its prox imal end is of greater diameter than 1 and 2 of Fig. 19) of the three or four coring and transport assembly 11 elements, according to certain embodiments, is a. distal sheath 590 which may be configured to fit over the work element 13 as shown in Fig.
  • a distal sheath 590 may also be configured to sl ide and fit over a proximal .sheath 584 that is mechanicall coupled to the work element 13.
  • a distal sheath 590 When the distal sheath 590 is combined wi h a: proximal sheath 584 and work element 13, it may be referred to as an inner assembly, which .may be fitted into an outer sheath,
  • a distal sheath 590 may comprise a distal portion 592 (shown extended, to the tips of the beaks within, but which may be shortened all the way to just distal of shoulder 593) having a first diameter, and a proximal portion 594 having second diameter. The second diameter may be larger than the first diameter.
  • a distal sheath may comprise a shoulder 593 comprising a s rface that transitions between the distal and proximal portions 592, 594 of differing diameters and against which the distal portion of a second helical element 585 of Fig, 19 may act, in one embodiment, furthermore, a distal sheath such as shown in thi s figure exte ded nearl to die tips of the beaks or only partway along the beak assembly 13 may be configured to core forward along the length of the scoopula of an outer sheath, such as 5.12 of Fig, 16B, while lying in the trough of the scoopula, which may be useful in ensuring that any tissue encountered woul not slide away from the scoopula by combining a forward cutting and side cutting mechanism s previously discussed herein.
  • the scoopula side cuts as it is rotated about the clock face in sampling or is moved laterally to a new target tissue site, and the beak or beaks forward cut as they core within the trough of the scoopula . Furthermore, s the beaks act against the sides the scoopula, there exists a. scissors action between the edge o f the scoopula and the beak or beak edges combine forward and side cutting by combined application of their individual cutting surfaces.
  • a distal sheath may ha e shoulders similar to shoulder element 593 of Fig, 20, Such first and second diameter portions of each of these sheaths may be incorporated to accommodate each other in configuration, but also t establish a further expanded expansion chamber portion of a: proximal sheat 584 proximal to its attachme t to a .monolithic beak assembly 13.
  • Such an expansion chamber which may be even greater than the inner diameter expansion that is simpl due to a proximal sheath's greater inside diameter than that of a monolithic beak assembly 1.3* may similarly serve to allow tissue sample expansion once clear of the corin and severing beak(s ⁇ .. which may farther aid tissue transport with or without a first helical element, and in. the presence of active or passive flush .fluids and/or aspiration as primary or secondary transport aids.
  • Such an expansion chamber may reduce inner wall friction between the tissue sampl -and the inner lumen of the device .10, as well as providing space for flus fluids, either passive or acti ve in motion, as will be shown in a further illustration below, to aid tissue transport to a transfer magazine 27 of the device, as shown in. PigJ ,
  • FIG. 21 is a view of a two-beak assembly with both a distal sheath 590 and the outer sheath 512 removed, according to embodiments.
  • Fig..2.1. shows: components of the work element. 13 (comprising, e. g., a body portion 428, one of a tendon actuation elements 469 and a first and second articulable beaks 602, 604 ⁇ mechanically coupled to a proximal sheath 584.
  • a distal sheath 590 is omitted in this view.
  • a proximal sheath 584 may be spot- welded to the work element 13 in such a manner as to enable differential motio of a body portion 42S of the work element 13 relative to tendon actuating elements 469 thereof when a second helical element 585 compresses and extends, which differentia! motion actuates e.g>, opens and closes) a fi st and second articulable beaks 602, 604.
  • a proximal sheath 584 to both a body portion 428 and to a tendon actuating elements 469 of the work element 13 results in substantially equal torque being imposed on the constituent element of the work element thereby maintaining the structural integrity of the work element as it is spun up to speed (by rotating a proximal sheath 584 in this embodiment) and as a first and second articulable beaks 602, 60 cut through variably dense, fibrous and vascularized tissues.
  • Fig.22 is a view of a configuration of a short monolithic (to distinguish over • the split tube- long monolithic single beak configuration of Fig. 15C t for example) single-beak 604 assembly, according to enihodlments.
  • Pig. 22 shows a body portion 428, a tendon actti doR element 469 and a. first articulable beak 604 of die work element 13 tog-ether with a first helical element 582.
  • a proximal sheath 584, a distal sheath 590 and an outer sheath 512 are -not visible in this view.
  • a first helical element may be co-axial!y disposed felative to a body portion 428 of the work element 13 and i»ay e of the same or substantially the same diameter.
  • the two may be formed of or cut from a single piece of material such as, for example, a stainless steel hypo tube.
  • a first helical member may be of a different diameter than a bod portion 42 S.
  • such an embodiment may require corresponding changes to the diameters of a .proximal sheath 584 and the proximal portion 594 of a distal sheath 590 and a change to a shoulder 593, if present
  • a single beak 604 may act against the side and forward edges of an outer sheath 512 (not. shown in this figure) as illustrated- b Figs. 2-15, according to embodiments.
  • a single beak 604 ma act against a scoopuia-shaped distal end portion of an outer sheath as previously described ,
  • a rotating proximal sheath 58 may serve to both rotate single or multiple beaks as well as provide the mechanism for opening and closing a beak or beaks by being itself moved axialiy disfally such that its distal end pushes up against a non- or differentially or same speed rotating distal sheatli 590, or a rotating proximal sheath 584 may serve- to rotate a single or multiple beaks of the work element 13 being attached to a proximal portion of a monolithic wo k element while an identically rotating distal sheath 590 may be attached to a beak tendon actuation elements 69, whereby the relative axial movement of proximal and distal .sheaths allows far beak actuation.
  • a BOB- or differentially rotating ot rotaiahie and removable outer sheath 51 tha may terminate, according to one embodiment, in a trough or scoopula shape, all of which for this device 10 are referred to as the tubular coring and transport, assembly .1 1 in Fig. L
  • a first helical element 582 may be provided to transport cored and severed specimen in the proximal direction, which ma be further aided or replaced by liquid flush induced into the central.
  • a first helical element 582 may rotate at a. different speed than that of a proximal sheath 584 and the beak element(s) 13.
  • FIG. 23 shows a top view of a mechanical arrangement: for tubular coring and transport assembly 11 rotation and actuation, according to one embodiment.
  • a outer sheaA 512 is not . shown for ease of illustration, bet" is shown in Fig. 26A, which illustrates the entire device 10, according to one embodiment.
  • a proximal end of a distal sheath 590 passes through a- front seal, which in this view is at the distal end of a housing of device 10.
  • A. distal sheath 590 is free to move against an internal spring., axiaily forward and back. According to one embodiment, the iota?
  • distance of sach novetneat m be about equal to a maximum sample ttssae length (not to scale, all relative distances such as Xmm 5 Ymm and corresponding Dx and Dy (D for distance) are shown for illustrative purposes only).
  • a proximal sheat 584 contained within a distal sheath 590 a «d rotating indepemientiy thereof, in this embodiment, may be seen passing through thrust bearing 60 A. in the forward wall of a proximal sheath carrier 609, A proximal sheath carrier 609 may be configured to slide axially inside a distal sheath carrier on slide 608, which is furnished with its own spring to effectively allow a return force to separate the two (distal and. proximal) carriers if they are pushed together, which causes : p oxi al sheath 584 to move backward or " forward, respeetiveiy, i relation to a distal sheath 590.
  • a proximal sheath carrier 609 therefore relates to the axial distance travelled between proximal and distai sheaths to open or close the beak or beaks 13 at the distal end of device 10 according to embodiments.
  • a proxinmi sheat 584 is also free to move ax l rathe distal and proximal directions- under rotation as a result of a thrust bearing 609 A described abo ve.
  • a proximal sheath 584 continues prcixirnally in this illustration through a vacuum seal 612 at forward bulkhead of vacuum chamber 61 1, which serves to capture any stray fcids that may not have been aspirated through the central, lumen of the whole tubular coring arid transport assembly 11 a d through a transfer magazine 27.
  • Rotational force for a proximal sheath 584 is provided b its gear 614 (which may, according to embodiments, be extended to also rotate a distal sheath 590 at the same speed if they rotate together as described in Fig. 22 above), i this illustration, which is driven by a proximal sheath pinion gear 613,
  • a first helical element 582 may also be ee in this figure, which first helical element 582, if present, may be driven at a different rotational speed than that of a proximal sheath by its own gear 616 and pinion gear 615, which may also drive a flush pump or vacuum system of the device (not shown , i such is provided, a first helical; element may terminate within a transfer magazine 27 in which tissue samples may be deposited serially.
  • FIG. 23 also shows that, according to one embodiment* distal and proximal sheath, earners ma terminate proximaiiy by vertical, side wails of any shape, md upon which a rotating dual c m: gear 620, witli individual cams swch as a distal sheath cam 618 mid a proximal sheath cam 61.9, act upon the vertical side walls of the two carriers.
  • the inner side wall s a d cam 619 correspond to the proximal sheath carrier 609 and the outer side walls and cam 618 correspond to the distal sheat carrier 606, it may be envisioned, depending on the side profile of each cam, as well as the side profiles of the two vertical side walls, that many different fine-timed configurations may actuate the same r .differential movement, acceleration and timing of differeutiai movement of the two carriers relative to each other, and thus to the combine and coordinated action of the distal work element of device 10 » according to enibodiments.
  • cams 618 and 6 ⁇ 9 may actuate the carriers equally, corresponding to distal-directed movement of distal and proximal sheaths, thus coring tissue with the beaks open and rotating. Upo reaching a certain axial distance, cam 19 may continue forward, closing the beaks and keeping them closed while both distal and proximal sheaths retreat p oxiraaliy carrying the tissue sample backwards and delivering it to a transport mechanism for e ventual deliver) 1 to a transfer magazine 27.
  • each carrier ma be asymmetrical to each other or in their upper or lower sections, dependin on the mechanical effect desired.
  • the cams themselves may be asymmetrical ' k their individual side shapes which, combined with special shapes imparted to the vertical rear walls of the carriers, may enable or result in extremel fine tun ng of the carrier axial movements at any desired point in time, defined by the revolut onary speed and instantaneous radial angle during revelation of twin cam gears at any ti me.
  • the twin cam gears of this embodiment may be powered by a worm gear 621 , which may allow for movement of the two carriers to be frozen in position at any desired stage.
  • the worm gear 621 may itself be driven by a pinion gear 623 movable on it pilot shaft 624 operating through a simple chito - mechanism 622.
  • carrier 609 and carrier 606 may be manually squeezed, together through a simple mechanical linkage (not shown), which may cause the beaks to close and part off or remain closed at an operator's choice.
  • rotation and axial movement axe independent of one another with such atr arrangement, and thus may be controlled with different actuation mechanisms to allow the device 10 to accomplish ail of its intended functions. Again, this illustration, is only one of many different mechanical arrangements that ma be envisioned by one of skill in the art, all of which are considered to be within the scope of this disclosure., and that may be se lected to enable the de vice to accomplish any or all of the following actions considered, characteristic of device 10, according to embodiments;
  • o Beak(s) closed and extended, with rotation, scoopala in pre-fiiing or extended mode', o Beak s) ope , either withdrawn, or extended, no rotation, seoopiria in pre- firing or extended mode;
  • Fig, 24 is an illustration of principl es of a different arrangement of a earn gea and cam f3 ⁇ 4I lower attange en , according to embo i ents.
  • This figure specifically looks at the time-based action of geared cam 620 (shown as the central circle i n this figure) but configured with two pins surrounded by bashings that act in a similar manner to cams 61 S and 619 from Fig, 23, and are thus labeled as such in this figure.
  • the geared cam wheel 62 is assumed to rotate in a clockwise direction, wit pin 618 (analogous in function to cam 61.8 of Fig. 23) being a short pin.
  • pin 61 (analogous in function to cam 619 of fig. 23), which is a longer pin that is capable at times of effectively acting on both the proximal sheath carrier 609 and the distal sheath carrier 606 vertical rear walls ⁇ simultaneously.
  • the larger arcs scribed in this figure correspond to the vertical rear wail surface of the distal sheath, carrier 60
  • the smaller scribed arcs correspond to tile vertical rear wall of the - proximal sheath carrier ' 609
  • the pins 618 and.6T9 are shown with their bushings only at the start of the cycle, for purposes of illustration., arid are shown as dots at various other locations ' which correspond to their movement at various time intervals with gear cam wheel 620
  • the gear cam wheel 620 is shown to the tight ofthe figure, with the arcs of the carriers extending to tire left to correspond with the independent carrier movement outlined in the previous Fig. 23.
  • the longer pin 61 is a shorter radial distance from the center of the gear cam wheel 620 than the short pin 18, which pin 618 acts only on the proximal sheath carrier 609,
  • the short pin. 618 is also lagging the long pin 619 in revolutionary time, which implies- thai it conies into play only at a certain point in the clockwise movement o the gear cam wheel 620.
  • ft is assumed that the rest position ofthe two carriers is when the long pin 61 is in the 3 o'clock position (beak ⁇ s) are open (labeled as "A * ' or zero time in terms of rotation time), both distal and. proximal sheath are at their c losest proximal point to the housing of biopsy device 10).
  • the figure includes a small microswite-h 632 with a pointer on the gearwheel* whose hinetio could he to stop/restart gear wheel 620 revolution when the long pin 619 is In its starling 3 o ' clock position, which action may correspond to the differcnce between .semi-automatic (one revolution and microswitch stops revolution until re-enabled) and folly automatic (rnicroswiteh disabled altogether and thus rotation and sampling continues until operator interruption of the process) sampling action of the device 10, accordin to embodiments.
  • the total excursion time of the distal end o the device 10 occurs in a single revolution of the gear cam 620, and the individual actions of the pins on the individual sheath carriers 606 and 609 are as described herein.
  • Such total sample (excursion) time may vary from as little as about 2 seconds to as long as ahoat 12 seconds, depending on embodiments, with, a nominally ' designated time of 4 seconds, in one embodiment If the ' total time for rotation is ssumed to be about 4 seconds, then rotational position ⁇ A" corresponds to zero, position '3 ⁇ 4 corresponds -to one second elapsed time, position "( to .
  • position 1- to three seconds elapsed time and the return to position A corresponds to four seconds total rotation time, assuming constant speed of gear cam wheel 620, which may also be variable., according to embodiments..
  • sampling cycle time is a function of the time of one revolution of the gear cam. wheel 620, and that the timing .for beak actuation is a function, of the placement o short pin 618 in relation t lon pin 19.
  • the arched (in one emlx>diment) configuration of the carrier vertical rear walls is only one configuration, but different profile shapes of each vertical rear wall will tend to accelerate or decelerate the actions of the pins on those surfaces, and many different vertical rear wall profile shapes are possible, depending on embodiments. Additionally, the profile shapes of the vertical fear walls of the carriers may differ from top to bottom to impose time-based factors on.
  • Total excursion, distance of the distal end of device 10 is shown as * 3 ⁇ 4" in this figure, and is a fimetiors of the placement of pins 618 and 639 and the diameter of the gear cam wheel 620, i one embodiment.
  • Such total excursion distance may be of any lengt desired, according to embodiments, and for one embodiment, such distance is nomiaally 1 inch or 2.54 centimeters, corresponding to maximum automatic sample length. Again, it should be noted that samples of any length maybe- obtained by the operator with device 10; as will ' be discussed further below.
  • Fig. 25 is a side view of a culling element actuation mechanism consisting of twin inner and outer sheath carriers, -such as 606 and 609 of Fig. 23, according to embodiments. From the preceding Figs, 23 and 24, it may be seen that rotation of gear cam wheel 620 will slide both carriers axia!ly distall and proximaliy, in differential movement to each other, as previousl described. Also shown in.
  • this figure is the distal, sheath 590 with its external return spring, a distal sheath socket and optional flnsh port .603, the proximal sheath 584, the proximal sheath thrust bearing 60 A, the gear earn wheel 620 with, its short bushed pin 618 and its long bushed pin 619, the gear cam wheel raicroswiieh 63 and the maximum forward travel proximal sheath carrier micros witch 633,
  • the vertical rear alls of each earner 606 and 609 are profile shaped as hemi-cirea!ar in form, and of nearly the same size, although other embodiments may alter the shapes of either carrier rear vertical wall to be of an shape desired, which will affect the action of the two carriers" axial movements, according to embodiments and as described under Fig.
  • the rear walls ay have special, features, such as elliptical shapes in their upper or lower halves, dimples, wavy shapes or any other shape desired, and one skilled in the art will recognize that such profile features will act with the pins of the gear cam wheel to accelerate or decelerate the individual axial movements of the two carriers, in relation, to each other, all such designs and corresponding movements of which are considered to be within the scope of this invention.
  • the profile shape of each of the two carriers may differ from eac h other, and the rear walls may be lowered in relation to the long horizontal ax is of each of the carriers, resulting in a cantilevered action on the: earners as imparted b the gear earn wheel 620.
  • Fig. 26A is a side view of internal and external features and elements of a biopsy device 1 Q
  • Figure 26B is a front end-on view of a shape of a biops device 10, according to embodiments.
  • the eekanisro of a distal sheath carrier 606 and a proximal sheadi carrier 609 with their elements of Figs. 23, 2 and 25 are shown i near scale size, according to embodiments, and are themselves carried by and slide a iai! withi drive mechanism carrier 640.
  • An outer sheath 512 may be field to the forward bulkhead of drive mechanism carrie 640 in a manner similar to the way that distal sheath 590 is socketed to ⁇ distal sheath carrier 606 s but is also easily removable from the device 10 by the operator if desired prior to, during or at the end of a procedure, thus being placed or left in situ for the purposes of pre or post-procedure cavity ( target tissue site) access for such purposes as the Introduction of markers, medicatiotiS'-ot llei'tnatenais as. well as drainage or as m introducer for additional devices. If it is placed p.re-procedurally,.
  • a outer sheath 512 may be easily coupled to handle 12 or housing of device 10 by a Luer lock system, for instance and in one embodiment, which would allow .for easy assembly and dis ⁇ assembly, as well as tor the connection of additional devices for fluid or solid delivery systems, drainage systems and other devices.
  • figures herein include a tubular coring and transport assembly J 1.
  • a proximal sheath pulle 614 (analogous to gear 614 of Fig, 23 s as will also apply to other pulleys in this figure, which correspond to various gears of Fig.
  • Th drive mechaiiism carrier may be used to slide nearly all of the internal drive components illustrated in this figure forward against a stop at the distal end of the handle 12 of device 10. which may correspond: to an internal forward firing mechanism for placement of an outer sheath and sc opula portion of an outer sheath 512 in. proximity to or through a lesion, as desired by the operator, and as described for such a procedure in Fig. 1 above. Alternatively, only the outer sheath itself may be forward fired without carrying the internal drive mechanism with it according to embodiments.
  • This outer sheath may be manually, or in other embodiments, automatically rotated to various "o'clock" positions b the operator through a simple manual or driven wheel or ratchet mechanism attached to an outer sheath 512 (not shown), it should be noted that according to embodiments, rotation of a proximal sheath, a. first helical element, if present, and a distal sheath (if rotated) are independent of the distal and proximal axial movement of the tubular coring and transport assembly 1 1 , and becau se of that feature,, aceording to embodiments, tlie operator may select various ftmetions of the device .1 at an time, as described previously under Fig. 23 above. f0!24
  • 26B is an end on view of a biopsy device 10, according to one emhodiment.
  • Various other end profile shapes are possible,. - nd are considered: within the scope of this disclosure.
  • the device lO's tubular coring and transport assembl 1 1 is located near the very top of the device, which may th us allow a better viewpoint for both the operator and the imaging devices used with device 10.
  • Fig. 26C shows transfer magazine 27, according to one embodiment.
  • 26D is a eross-sectiona! view of a transfer magazine 27 of Fig. 26C, taken along cross-sectional line AA% and Fig. 26E shows a view of an internal collection tube that .may be split open as shown therein.
  • a transfer magazine 2? may coMain an internal elongated tube 422 (as shown in Fig, 2 E) configured to receive cored and severed tissue specimens.
  • a transfer ma azine 2? may be configured to receive and (e.g, temporarily) store cored tissue specimens or samples., and to preserve the order in which the samples were acquired.
  • a transfer magazine 27, may be configured to store a serial train of tissue samples, from a first sample at one end of the serial train of samples to the last sample acquired at the opposite end of the serial train of samples.
  • the first sample taken may be urged within an elongated tube 422 to be closest to the distal end of a transfer magazine, wherein proximal and distal quali bombs are defined relati ve to the biopsy device.
  • the distal end 406 of a transfer m azine 2? is closest to the beak assembly 13 and die proximal end 404 of transfer magazine 27 may form one of th proximal- most structures of the present biopsy device.
  • a transfer magazine 27 may address various clinical needs by enabling the operator of the present biops de vice to inspect the core samples more closely , and in some cases tactileiy, without destroying th record-keeping function of transfer magazine 27,
  • a transfer magazine 27 is referred to as such, as the storage of the cored and severed tissue samples may fee short iemt
  • a clinician may segregate the contents of one transfer magazine 27 from the contents of another, additional transfer magazine 27.
  • the operator of the present biopsy device may als have the abilit to interrupt eoring/fransport storag with, another function of biopsy device, all the while ⁇ at the operator's discretion, keeping the present biops device' tubular coring and transport assembly 11 in place, or ' alternatively elements of such assembly 11 , such as a removable outer sheath 5 ! 2, thus minimizing trauma associated with repeated removal and insertion of the present biopsy de vice .
  • a transfer magazine 27 may comprise a single or multiple piece assembly which may include a tube or tubes 422 extending forward inside the device all the way di tally to monoli thic beak assembly 13. in place of a first helical element 582, or alternatively may extend only to the proximal end of either a proximal sheath 584 as shown in Fig. 26A or to the proximal end of a split tube Song .monolithic beak assembly such, as shown in Fig.
  • sad may also contain slots a ranged to allow for flush s stems to direct fluids in such a manner as to akl transport of the tissue s ecimen and also collect body fluids for subsequent analysis, in such embodiments, flush fluids and aspiration by vacuum, would enable continuous transport of specimens from the distal end of the device to the main body of transfer magazine 27, and a transfer magazine 27 may either he separated from its distal transpor tube, if present, according to embodiments, or removed from the device with its integral transport tube.
  • a transfer magazine 27 may either he separated from its distal transpor tube, if present, according to embodiments, or removed from the device with its integral transport tube.
  • Such a System would maintain vacuum integrity within suc simple mechanisms from the distal end of the device to its most proximal end.
  • An elongated tube 422 may also comprise a central track or inner transfer magazine track, such as shown in Fig, 26B below, configured to receive the serial tissue specimen, and, according to embodiments, m ' be fitted with a Luer-lock type fitting for easy attachment to the device.
  • Vacuum may be provided via an axial vacuum port, for instance in the expanded region of Fig. 26 at the distal end of the magazine, which may allow fo only one vacuum connection to be required by the device, according to embodiments.
  • the present transfer magazine 27 may defin vacuum holes through which a vacuum, may fee drawn between the outer tube 402 and the inner tube 422, whic receives the samples in serial order.
  • these vaciruni holes may be lined with a filter element, such as sterile filter paper or other filter media, to catch and filter ceils and other materials from any fluids that accompany a tissue sample to the transfer magazine.
  • This vacuum may urge the cored and severed tissue specimen i the proximal direction., towards the proximal end 404 of transfer ma azi e 27.- Having reached the proximal end of the interior track, the cored and- severed: tissue specimen may come to rest and may , according to one embodiment, block or occlude one or more vacuum holes disposed along the length of an elongated inner tube 422. I this manner, no farther vacuum will be draw through such blocked vacuu hole(s).
  • This blocke vacuum hole or holes keeps the just-obtained tissue specimen in place (at the proximal-most availabte slot along the interior track of the magazine 27) while allowing more distaily-disposed vacuum: holes to continue to draw the vacuum therethrough and to continue to urge later-obtained samples to the next-distal position within the magazine.
  • a transfer magazine 27 may be considered to be full A full transfer magazine 27 .may then be withdrawn from the biops device, A new transfer magazine 27 may then be provided and inserted into the biopsy device to continue the procedure, if desired.
  • a transfer magazine 27 may fee withdrawn from and replaced back into, the biopsy device, without interrupting the procedure and without ithdra ing the work element 13 from the tissue. Moreover, withdrawing a transfer magazine 27 allows access to th interior lumen of the beak assembly, which in turn allows any number of imaging materials of devices, cosmetic materials or dierapetincally-beriefici l substances to be delivered, or fluids and/or cells to be evacuated from, the target site,
  • a magazine capping and sealing element 408 may be coupled to the distal end of the magazine 27.
  • a capping and sealing element 408 may be configured to sea! the collected samples, cells and any fluids collected fro the outside, to enable ready transport, imaging, direct visual observation or even tactile manipulation,
  • a capping and sealin element 408 may comprise a fluid release element 410:
  • a fluid release element 410 may comprise, for example, an ampule of fluid surroynded and sealed within a soft covering of > .for example, rubber or viny l.
  • the soft covering ma be squeezed between the user's fingers to crush the ampule of fluid, which flui may then fee released t permeate the interior of a transfe magazine 27,
  • the fluid released may comprise a preservative configured to preserve the tissue architecture and prevent degradation of the collected tissue samples.
  • Other fluids e.g.., stains
  • a transfer magazine 27 inner track may comprise a clam-Shell structure.
  • a transfer magazine 27 inner track may comprise a (living, for example) hinge 414 so as to enable the transfer magazine 27 to be opened along its longitudinal axis and its contents directly viewed by the user or pathologist.
  • a transfer magazine enables an one or all of the samples to e withdrawn from a transfer magazine 27 for close examination and, if desired, replaced therein, without disturbing the sequential order in which die samples were stored.
  • a transfer magazine 27 may comprise visible markings and/or radio opaque markings 412, to assist the user in determining the order in which the samples were obtained.
  • Such markings may, for example, comprise numbers or identifying features appearing on the elongated tube 422.
  • the number "1 " may be visible in the proximal-most position of a sample with a transfer magazine, followed by " " for the location of the next Specimen, an m on. It i then easy to ' correlate the specimen with tlie location from which the specime was taken. For example, if 12 specimens were taken "around the clock", th first specimen will correspond to the 12:00 o'clock position and the 7* sequentially disposed specimen within a transfer magazine 27 will correspond to the 6:0 ⁇ o'clock location with the body.
  • visible markings 412 ma consist of metric o imperial ruled markings for ease of sample length measurement, and may also be radio-opaque or embossed with individual transfer magazine mtrabers to distinguish multiple magazines from each, other.
  • Par or all of a transfer magazine 27 ma comprise or be formed of transparent material, so as to enable direct visualization y the user of the obtained specimen,
  • a transfer ma zine 27, according to embodiments, may be lucent to other imaging .modalities, such as MM, for example.
  • the vacuum holes disposed along die length of the elongated tube 422 are visible in this view at 416. I an embodiment, features may be included within a transfer magazine 27, for example on.
  • outer tube 402, thai could be configured to magnify and/or illuminate the acquired specimens.
  • Fin-like extensions 4.18 may be provided, to enable an. opened transfer magazine 27 to lie in a stable manner against a flat surface. Such fins may be asymmetric relative to each other to aid in. stabil ity of the device when placed upon an unstable or irregular surface.
  • a transfer magazine may be provided with snap or interference fittings 420 to enable a magazine 27 to he manually opened and dosed and reopened ' 'xeclosed.
  • a tissue biops method may comprise performing coring / biopsy / transport cycles as described above. Thereafter, removin a transfer magazine and/or proceeding to marking and/or ' treatment phases may complete the procedure. A transfer magazine may then be removed and, if desired, placed ' under -ftay, magnetic resonance imaging and/or ultrasound transducer or high-resolution, digital camera- if a transfer magazine is made of tmnquainti mat ial. Th core ti sue Specimens may then e -hinged/recorded.
  • the magazine may then be placed in a delivery receptacle, sealed and delivered to a lab for further analysis, making note of core lengths and -correlating with imaging record(s) in-sttu and ex-vivo.
  • the collected cores may then be visually inspected through the transparent walls of a magazine.
  • the magazine may then be split open to .manually handle and analyze the tissue specimens as desired as well as to collect an .fluids- or ceils for cytologic analysis.
  • the magazine may then be closed again, with the specimen, therein.. ⁇ 32 ⁇ A transfer rnag. azine 2? may then be re laced with additional empty transfer magazine(s) as needed, to complete the biopsy procedure.
  • cartridges / magazines may be fitted to the present biopsy device to deliver medications, markers and/or tracer elements, , therapeutic -agents, or therapeutic and or cosmetic implants to the biopsy site.
  • Still other devices for imaging or therapeutic purposes may also be placed into the device In place of a transfer magazine, as desired and according to embodiments. The procedure may then/be terminated, or continued, such as would be the case should the practitioner desire to biopsy /cote other nearby areas as deemed clinically useful.
  • a device 10 with a outer sheath 512 with a scalpel-like distal end may be gently placed in proximity to or through a lesion, or may be forward-fired through the lesio using the internal mechanism of device 10, according to embodiments.
  • the -ability of a biopsy device to advance gently towards a target lesion provides several advantages, indeed, when a biopsy device does not advance gently toward a target lesion or does not smoothly core through dense target tissue, the operator may be led to exert excessive force onto the biopsy device, thereb potentially forcing- the biopsy device into and even through adjacent structures.
  • t enables a operator to gently and smoothly approach a target lesion without requiring excessive manual axially-directed force to be exerted o th present biopsy device, by the operator or by the stereotacti c table itself, if used, ft is to be noted thai when excessive feree must be exerted to advance conventional coring: devices through dense tissue, the resultant image provided by guidance modalities may be significantly distorted by the effects of the applied force onto the conventional coring device and transferred to the surrounding tissue, which may cause the resultant image to be less distinct or blurred, which, in turn, makes the biopsy procedure less accurate and much more difficult technically. This excessi ve force may also damage tissue, resulting in loss of tissue architecture and production of the aforementioned biopsy artifact.
  • meeharnsms may be irieor or ted into the biops device I Q, accordiag to embodiments, to aid in tissue specimen transport to t e transfer ma axine 27,
  • Such mechan sms may consist of the distal tube socket. / flush port 603 of Fig. 23, which may deliver Hus fluids to the distal end of the device between the distal and proximal sheaths,, or. similarly with another ' analogous port between the distal sheat and outer sheath 512, with- flush fluids being connected t th device through port 638 of Fig. .26 A * for example.
  • Flush fluids and other materials may also be delivered to the tissue site through the central lumen of the device, with he&fcfs) closed (as described for liquids under Fig, 5 above through the living hinge slots) or open,, using the aspiration port 639 shown i ; Fig, 26 A or through a transfer magaz ne 27 of Fig. 1 above, according to embodimen s..
  • Flush fluids may also be delivered to the distal tip through ports in the collar 593 of the distal sheath sho n in Fig. 20 above.
  • fluids, solids and other materials may be delivered to the tissue site through the central l umen of the device and various slots and echanisms such as the open beafc(:s) may be used in conjunction with . flush iuids to gather and transport cells and liquids from the tissue she for later cytologic*! analysis.
  • Fig. 27 A is a first view of a stereotactic: table adapter for a biopsy device, accordin to one embodiment
  • Fig. 27B is second view of a stereotactic adapter for a biopsy device, according to one embodiment, in Figs, 27 A and 2711, reference 270 denotes some type of generic interventional device.
  • Reference numeral 278 represents the distal end of the excisions! device, whereas numeral 277 represents the proximal end of the generic de vice 270.
  • 277 may represent a source of vacuum.
  • the distal tip of 278 may be provided, for example, with a monolithic beak assembly, a described and shown herein.
  • the excisional device 270 may rest upon stereotactic platform 276, which may be coupled to th stereotactic table stage.
  • aft exeisionai device may be coupled to the stereotactic platform 276 through one or more capstan assemblies 272, 274,
  • One or more of the capstan assemblies 272, 27 (or windlass assemblies, by virtue of their horizontal axes), may be provided to enable the user to change the orientation or angle of attack of the excisional device 270 relative to the platform 276 and thus relative to the stereotactic table stage as well.
  • the capstan assemblies 272, 274 may be, according io one embodiment, secured to both fee excisiona! device 270 and to the platform 276.
  • the capstan assemblies 272, 274 may enab le one or both ends of the excisiona! device 270 to be moved along the x- plane (e.g., up aid/or over a device penetration axis along z). lit so doing, the proximal end of the excisiona! device may be raised and or moved off-cente relat e to the platform 276, by manipulating the capstan assembl 272. Similarly, the distal end of the excisiona! device may be raised and/or moved off-center relative to the platform 276 by manipulating the distal capstan assembly 274, Both, the proximal and the distal ends of the excisiona!
  • the device 270 ma be raised or moved off center, either i the same or different manners. This enables flexibility and 3 ⁇ 4e-graineti control of the orientation of the excisiona! device 270 independently to the orientation of the stereotactk table stage, or in contraction with it, as small adjustments in the orientation of the proximal end of the device have a correspondingly larger effect at the distal end (i.e., working end) of the device 270. In turn, tins • ma -enable the user to exert great control of th location within the body from which the samples are cored and severed (or ablated, dissected, etc., depending upo the nature of the excisiona! device 270).
  • the user may adjust the orientation of the device 270 by turning a actuator such as ship's heel 271 of the capstan assembly 272 in either of the directions indicated at 273 and/or by turning ship's wheel 279 of capstan assembly 274 in either of the directions- indicated at 275.
  • the capstan assembl 272 may be operated. Using other forms of actuators. Moreover, such an actuator need not be operated by rotation, as ts the ship's wheel 279 shown and described herein, as those of skill i this art may realize.
  • the user may selectively move the proximal end of the device and or the distal end thereof up and off-center (relative to its I ni tial centered position shown, in Figs,. 27 A and. B * pl37j Fig, 27C s a side cutaway view of a platform, suitable for a. stereotactic table stage, on which an excisiona! device 270 may be coupled according to one embodiment.
  • the p!alfomi, similar rs feficttou t element. 27 of Figs. 2?A and 27B may comprise an upper adapter plate 360 and a lower adapter plate 358.
  • the lower adapter plate 358 may be coupled, at 36 , to the stereotactic table stage 364.
  • the lower adapter plate 358 therefore, may he held immobile with respect to the stereotacti table stage 364.
  • T!ie upper adapter plate 36 may be movably coupled to the fixed lower adapter plate 358 through, for example, two or more pivot arms 357. Therefore, the upper plate 360, to which, the excisiona! device 270 is fixed, may move relative to the lower adapter plate 353 ⁇ 4. : As sho s:, each end of the upper adapter plate 360 (and thus the exciskraai device 270) ma move somewhat .Independently of the other d of the -upper adapter plate.
  • each of the upper and lower adapter plates comprise descending extensions with the lower adapter plate 358 comprising the inner descending extensions and the upper adapter plate 360 comprisin the outer descending extensions that are generally parallel to the descending extensions of the lower adapter plate 358.
  • the capstan assemblies 272, 274 of Fip. 27 A. and 27C may be fitted in the space between the descending extensions of the upper adapter plate 360 and the descending extensions of the lower adapter plate 358.
  • the capstan assemblies 272, .274 may be fitted over respective central pins of the lower plate 358 such that the ship's wheels 271. 279 ate coupled to the descending extensions of th lower adapter plate 358.
  • the stereotactic devices commonly encountered today take a series of biopsy samples starting with an initial sample, with subsequent samples being taken by manually rotating the outer sheath of the distal end of such devices hi a. manner so as to sample "around the clock.”
  • the capstan assemblies 272, 274 allow for additional movement of any stereotactic biopsy device in a greater range of motion, than is currently available through the use of the stereotactic table stage controls for x ; y and z placement of e: de vice.
  • the proximal and distal capstan assemblies 272, 274 may not only be rotated in synchronism, with one another but also may he rotated differentially relative to one another* such that angles can be obtained hi addition to displacement.
  • Such movement may he accomplished by manual manipulation but may also be directed by software executing within a stereotactic biopsy device controller.
  • the abilit to rotate the two capstans 272, 274 independently or i synehronieity enables an. interventional radiologist to gala access to otherwise difficult anatornkal locations without .repositioning the breast, for e m e *
  • the addition of one or more ca st n assemblies 272, 274 acid polar coordinate orientation capability to an. otherwise ⁇ Cartesian-restricted machine., and vice versa.
  • a capstan, assembly 272 may comprise a ship's wheel 271 fitted with extending prehensile features 372 around the ⁇ circumference thereof to enable the user to easily turn the ship's wheel 273 about a central pin of the lower adapter plate 358 of Fig, 27C, for example,, which Is configured to fit within central well 370, to ena l the ship's wheel 271 to rotate thereabout-
  • the ship's wheel 271 may comprise a wheel guide extension 374, disposed between the central well 370 and the outer circumference and substantially parallel to the wheel central well 370,
  • a notched inner washer 375 may fit over the wheel wel l 370, such that the wheel guide extension 374 fits within the notch of the inner notched wheel 375.
  • the wheel guide extensio 374 travels within the spiral pathway 377 defined within the spiral path element 376, which may be coupled to the upper adapter place 360 of Fig. 27C fo example, i so doing, the spiral guide element. 376 is shifted away from the substantially centered configuration shown in fig. 28C to the more eccentrically-disposed configuration, shown in Fig. 2 D f That is, when the wheel guide extension 374 is disposed within the spiral pathway 377 closest to the central well 370. the spiral path element 376 is substantially centered on. the ship's wheel 370, as shown in Fig.
  • the upper adapter plate 360 is in first, initial configuration.
  • the spiral path element 3 6 deviates more and more from its initial centered position to an eccentric position relative to the wheef well 370, as shown at Fig. 28B.
  • the wheel guide extension 374 forces th spiral path element 376 some distance in the x ⁇ y plane (see Fig. 27A), to thereby force the uppe adapter plate 360 to correspondingly move the same amount along the x- ⁇ y plane.
  • the amount of eccentricity of the -spiral path element (and thus movement of the upper plate 360 relative to the lower plate 358) m y be readily adjusted by the aser b fine-tonfeg the taming of the ship's wheel 271, as well as by simultaneously numipolating either or both capstan, assemblies with the stereotactic table stage x, y,.z controls as described above in paragraph 62.
  • he-Heat element ami the terms “helix” or “helices” are intended to -encompass a broad spectrum of structures., indeed, the structures shown herein are but possible implementations of a helical element, helix- o helices. According to other embodiments, “helical element”, 'liefix' of “hel ces ' ' arid equivalent expression rimy be implemented as tubes having one or more slot-shaped openings or fenestrations along. at least a.
  • Such fenestrations may be substantially parallel to the longitudinal axis of the tube or ma be disposed, for example, in spiral configuration.
  • the fenestrations may be continuous along at least a portion of the length of the tube or maybe discontinuous, such, as to result in a plurality of such parallel or spirally wound fenestrations.
  • the fenestrations may be very wide such that the resultant structure- ⁇ resembles a spring, or more narrow, such that the resuliing structure more closely resembles a tube having narrow,, slot-shaped openings therein, Th eontiuuous or diseoutinuous fenestrations ma he caused to assume other configurations along at least a ⁇ portion, of the t bes in which they are formed.
  • the fenestrations may be caused to form a zigzag pattern such as "NNNN"..
  • FIGS. 29A-29D show structure- of another embodiment of an excisionai device according to one embodiment.
  • the structure referenced by numeral 280 of Fig. 29 A may replace the first helical -element described above and may discbarge, together with the proximal sheath shown at 284 in f ig, 29B, the tissue transport &»etiot ity. That is, the helical element 280, which ma rotate independently of the work elemeni(s), urges the cored, and severed specimen from the distal portion tiiereof to the transfer ' magazine 27.
  • the helical element 280 may be formed of a hollow tube in which one or more slot-shaped openings or fenestrations 282 may be defined. Such fenestrations 282 may be continuous or discontinuous, non-overlapping or overlapping. In the implementation shown in Fig. 29 A, a plurality of fenestrations 282 (which may foe laser-cat from the tube fo ing the proximal sheath), ar disposed In a generally spiral configuration. Other configurations are ossi le.
  • Fig. 2 B shows one embodiment of a proximal sheath 284 of ail excisional device accord mg to one embodiment
  • the proximal sheath may discharge a dual ftmctlon of actuating the tewdon actuating element 469 (if conf ure as in. Fig, .19) through differential motion thereof with the body portion 428 (Fig. 1.9), as well as working In concert with the helical element 280 to transport the cored and severed tissue samples proximally toward the storage or transfer magazine 27.
  • the proximal sheat 2:84 may be conpled to the body portion 428 and to die actuation element 46 of the work element as shown, for example, in Figs, 21 arid 22, As shown In Fig. ; 29B, the proximal sheath 284 may comprise one or more slot-shaped (for example) fenestrations 286.
  • the fenestrations are narro slots that are- disposed I a spiral pattern,: These slots may be continuous or discontinuous overlapping or non- overlapping, of uniform or non-uniform width. Fenestrations, slots or openings of different shapes are expressly encompassed herein.
  • the fenestrations 2S6 may be spirally- wound around die tube, andthe direction of the resulting spiral pattern may be the sam as that of the helical element 280.
  • die respective spiral (or other) fenestrati n patterns may b crossed such that the fenestration pattern in the helical element 2.80 cross the fenestration pattern in the proximal sheath 284 or not, depending on the relativ e axial position between these two helical, elements at any given time, as shown.
  • Fig. 29
  • effective tissue transport may be achieved when the fight balance is achieved between the resistance to tissue advancement as between the helical element 280 and inner wall of the proximal sheath 284.
  • the proximal sheath 284 is fitted over at least a portion of the helical element 280, as shown end-on in Fig, 29D, Fig, 29D shows the annular space 288 formed between the outer wall of the helical element 280 and die inner wall of the proximal sheath 284.
  • a flush ma be incorporated in the annular space 288, or between the outer sheath (which may actually take the form of either a distal sheath 590 or an outer sheath 512 previously referred to in other figures, but referred to collectively as 590, according to embodiments and as shown in this figure for simplicity) and inner sheaths, to litrther facilitate tissue transport.
  • a vacuum ma be drawn within at least the helical element, which raayftuther facilitate tissue transport. This enables the user to collect any fluids to enhance cleanliness during the procedure, to help, with visimiizatioa and to collect cells for cytology.
  • an inner helical element 280 ma .not be present, while other embodiments ⁇ such as those using a split tube long monolithic beak assembly, such as previously described in Figs. ISA, 15B and ISC above, may only have two concentric tubes, which ma be considered, to be an outer sheath, and the inner long beak assembly.
  • the fenestrations defined in the proximal sheath 284 and in the helical element 280 may enable a helical jumping'' feature and to create a reservoir of fluids surrounding the tissue, which may enable a swirling wave action to interact -with, the cored and severed tissue samples to gently push them in the proximal direction.
  • the fenestrations in both the helical element 280 and the proslmal sheath 284, as examples of Such fenestrations or features lessen the .respective wall surface areas of these structures and thus decrease the surface friction experienced by the cored and severed tissue sample, both of which (wall surface area and friction) impede transport.
  • Such structures als exhibit a favorable "sealing" effect surrounding the tissues, particularly where irregular tissues might, based on thei own surface architecture, engender vacuum leaks. Indeed, the gentle urging of the cored and severed tissue samples preserves the underlying tissue architecture and delivers 3 ⁇ 4 ⁇ clinically-useful sample (e.g,, one whose tissue architecture has ot been unaeeeptahly damaged during its transport to the transfer magazine 27.
  • a thin outer sheath 590 may be disposed over at least a portion of the proximal sheath 284.
  • the thin outer sheath 590 may be configured to be non ⁇ or manu lly rotating.
  • the outer sheath 590 (shown in Fig. 29D) may be formed of or comprise, for example, polyimide.
  • the nan* ot: difierentialty rotatin distal sheath may be configured t fit over the work element as shown i Pig. 19 comprising the body portion 428, the tendon actuating element 469 and at least a portion of the first or first and (if present) articulable beaks >
  • the outer sheath 590 ma he configured to slide and fit over both the distal and the proximal sheat 584 that is mechanically coupled to the work element.
  • the inner or first helical element ma be deleted entirely; but the helical slots previously shown in element 280 of Fig. 28 A may be incorporated into such distal sheath.
  • the outer sheath 590 may cover the distal sheath to prevent, or lessen tissue wind-up during rotation.
  • the outer sheath 590 ma also create an annular space for flush to travel forward to its distai end, depositing fl ush, ane heties* aiAieoaguiants* vasoconstrictors and the like to the very distal end of the work element; that is, to the beak or beaks and/or to the scoopula-shaped distal end of the device.
  • the outer sheath 590 ma function to protect the beak(s) of the work element durin opening thereof, to prevent the beafc(s) from experiencing too great strangulation forces, as the beak(s) ofthe work element may be caused to move slightly proximally daring beak opening, such that the beaks open (for the most part) under the shelter provided by the outer sheath 590,
  • the thin (e,g, ? polyraiide or thin hypotube) outer sheath also protects the tendons and the living hinge areas of the work element, as weli as the distal portions ofthe beak o beaks by removing some of the rotational resistance.
  • outer sheath 590 may also provide cover and protection tor at least part of the distal sheath and proximal sheat 284 that does not flex inward with the living hinge and work elements, such that these do not snag tissues during forward excursion within tissue.
  • a polyimide or other material outer sheat 590 may have a naturally or coated iubrlciou surface that is highly impervious to chemicals that the excisionaf device is likely to ' encounter and can readily be sterilized.
  • i SO] Fi s. MA and 30B slow another embodiment of a work element according to one embodiment. Specifically , the work element 13 in. Fig,. 3GA Is similar ' to that shown in Figs.
  • the body portion 428 of the work- element 13 may be meclmrilcal!y coupled to the tendon actuating element 469 at the proximal end of the work element.
  • the tendon actuating element 469 from the embodiment of Figs. 21 and 22, is already coupled to the body portion 428 through the tendons 468, 70, toward the distal end of the work element 13. That is, the entire work element 1 may be formed of a single homogeneous material ⁇ such as from a single hollow tube that is (for example) laser-cot to form the structures shown in Figs * 30A and 30B.
  • the work element 13 may comprise multiple beaks or a single beak that acts against a non- moveable part such as a fixed trough-shaped or scoopula-shaped distal portion of an outer sheath, such as element 512 from Figs. I SA and 1 B above.
  • fOlSl j According to one embodiment, as - shown i Figs, 30A and 3GB, the proximal, end of the tendon actuating element 46 may be mechameali coupled to the proxirnai portion of the body portion 428.
  • Such mechanical coupling may be configured to maintain th teiKiott actuating element centered on the cutout in the body portion formed to accommodate the tendon actuating -element 469 and/or to provide additional biasing force In the .-distal direction, as well as to aid in manaikciuiing, Que embodiment comprises resilient member 42?
  • Such a resilient member 427 may be configured to bias the beak or beaks of the work element 13 in the open configuration., such that sufficiently great proximaily-directe force applied to the tendon actuating element 469 tends to close die eak or beaks . Conversely, release of snob proximal ly-dlrecied force causes the. resilient membe 42?
  • attachment holes 29.2 A and 292B may be provided on the body portion 428 and on the tendon actuating element 469, respectively.
  • Such attachment boles 292 may, according to one embodiment, indicate the location of, for example, spot welds, as detailed below.
  • ft! 53 ⁇ -Fig. 31 SHOWS a distal portion of a proximal sheath according to one embodiment
  • the proximal sheath 300, as shown in Fig. 31 may comprise a number of fenestrations or slots 304 that tun through the wall of the proximal sheath 300,, from an outer surface to the interior lumen thereof.
  • the distal portion of the proximal sheath 30 ⁇ may be configured to- .tit over aad a tach to the proximal end of the monolithic beak, assembly 13 of Figs. 30A and 30B.
  • the attachment holes 308A and 308B of the proximal sheath 300 may be lined up wit the attachment holes 292 A and 292 B, respec tively, of the monolithic beak: assembly 13 and the proximal sheat 300 attached to the monolithic beak assembly 33 at attachment points 292A. 308A and 2-92B.. 3088.
  • the attachment point 308A of the proximal sheath 30 may be spot-welded to the attachment point 292 A of the tendon actuating member 469 of the monolithic beak assembly 1.3.
  • coTOspoiidmg ' attachment points may be provided on the hidden side of the device.
  • the attachment point 308B of the proximal sheath 300 may be spot-welde to the attachment point 292B of t e body portion 428 of the monolithic beak assembly 13.
  • the distal portion of the proximal sheath 300 may define a resilient or spring portion, as shown at reference numeral 306.
  • Fig, 33 shows the distal portion of a distal sheath 320, according to one embodiment.
  • the distal sheath 320 may be configured to fit over the proximal sheath 300 and the attachment point 326 of the distal sheath 320 attached to . tac ment point 310 on the proximal sheath 300, as shown in Figs. 32 and 34.
  • the attachment porat 326 of the distal sheath 322 may be spot-welded to attachment point 310 on the proximal sheath 300, as suggested in Fig. 34,
  • the distal sheat 320 is transparency illustrated i Fig.
  • spot-welding is ho one method of attaching die constituent components of the present exdsional device to one another.
  • Other attachment technologies may also be used, as appropriate.
  • Fig. 35 shows one embodiment of tile present exeisional device, in a still further intermediate state of assembly.
  • an outer sheath 330 has been fitted over the assembly comprising the monolithic beak assembly 13, the proximal sheath 300 and the distal sheath: 320, and for purposes of illustration, without the seoopula shaped exirem y that would be formed in the continuation of the outer sheath, in order to show the beaks 13 easily.
  • the outer sheath 330 ma -comprise: polyimide or may comprise or be formed of stainless steel.
  • the outer sheath 330 may be configured, to be manually rotating, non-rotating, or at least differentially rotating with respect to the- assembly -comprising me monolithic beak assembly 13 s the proximal sheath 300 and the distal sheath 320. That is, while the assembly comprising the assembly monolithic beak assembly 1:3, the proximal sheath 300 and the- distal sheath 320 may rotate at relatively high rates of speed (in the thousands of revolutions per minute, for example), the outer sheath 330 ma be held stationary or rotated as needed, either manually or otherwise actuated by any mechanical means..
  • the user may rotate the outer sheath 330 few tens of degrees at a time, as and when the procedure requires, for example in sampling around the clock as previously described.
  • the outer- sheath 330 may extend distal ly to the beaks of the monolithic beak assembly 13, may expose a greater proportion of the monolithic beak assembly 13 or may cover a significant portion of the beaks.
  • one "side" of the outer sheath 330 may form a trough or seoopula shape and extend at least slightl beyond th distal-most tip of the beak or beaks of the monolithic beak assembly i 3, ndeed , the embodiment show and described rel tive to Figs, 29.A through 33 may comprise a single beak or two or more beaks,
  • the outer sheath 330 may be dimensioned so as to allow an annular space to exist between the outer surface of the distal sheath, the distal portion of the monoKrhic beak assembl 13 along with the distal sheath 320 arid, the inner wall of the outer sheath 330, This annular space allows for flush to be introduced at selected stages i the procedure.
  • the flush may provide lubrication for the rotation of the assembly comprising the assembly monolithic beak assembly 1 S the proximal, sheath 300 and the distal sheath 320 and may facilitate the rotation and thus the transport of the cored and severed tissue specimen in the distal • direction.
  • the fenestrations or slots 304 (Fig, 31) defined in the proximal sheath 300 are not lined up with th fenestrations or slots 324 (Fig, 33) defined in the distal sheath 320.
  • the fonestrauons or slots 324 defined in the distal sheath 320 become or are lifted up or substantially lined up with corresponding one or ones of the fenestrations or slots 304 defined tn the proximal sheath 300.
  • a vacuum may be drawn within the interior lumen of the device.
  • the force imparted on the cored and severed tissue specimen together wit the force imparted on such specimen by the flush enterin this interior lumen, draws and transports the cored and severed tissue specimen in the proximal direction, for eventual transport to the transfer magazine 27, for example.
  • Transport may he aided by die shoulder shown at 332 in Fig. 35. Indeed, this shoulder encompasses the location define by the proximal end of the monolithic beak assembl 13 and the distal end of the proximal sheath 300, As the diameter of the proximal sheath 300 is somewhat greater than that of the proximal end of the monolithic beak assembly 13, the interior lumen of the proximal sheath 300 is correspondingly greater than the interior lumen of the monolithic beak -assembly 13. As the cored and severed tissue specimen enter the interio lumen of the monolithie beak assembly 13 , they may he some what compressed .
  • Such compression may be somewhat relieved as the tissue specimens transition from the lumen of the monolithic beak assembly 13 to the lumen of somewhat greater diameter of the proximal sheath 300, at shoulder 332.
  • This decompression of the tissue specimen in the lumen of the proximal sheath 300 may, together with the flush and the vacuum, also facilitate tissue transport.
  • the shoulder at 332 could expand the inner lumen diameter in the range of 0.001 inch to 0.100 inch additional over the original lumen internal diameter or double die lumen internal diameter, whichever is greater.
  • shoulder features ma he incorporated into the proximal sheath, distal sheath and outer sheath to augmen such, tissue xpansion/nansport action.
  • Fig. 36 is flowchart of a method ccording to one embodiment
  • block ⁇ 36 ⁇ calls for providing a device.
  • the provided device may comprise an outer sheath and an inner assembly configured to be received - ⁇ at least partially) mtkm the outer sheath.
  • the oute sheath ma define a diameter, a longitudinal axis, a proximal portion ami ma comprise a fixed, distal scoop or trough-shaped open portion *
  • the inner assembly may define a proximal portion, a distal portion and a body portion between the proximal and distal portions.
  • the distal portion may comprise an articulable beak element configured to cote th ough and cut tissue.
  • Block B362 calls for insetting the fixed distal scoop-shaped open portion of the biopsy device into tissue through an incision, with the articul ble beak eter eni(s) in a closed configuration relative to the fixed distal scoop- shaped open portion.
  • the articulable beak, element may be opened relative to the fixed distal scoop-shaped open portion and a step of coring through the tissue may be carried out.
  • the articulable beak element may be rotatin during all or part of the coring.
  • the ⁇ articulable beak element may then be dosed and the cored tissue may be parted-off against the fixed distal scoop-shaped open portion, as shown at B364.
  • the articulable beak element may be rotating during the parting-off.
  • the parted-off cored tissue may then be transported- i» the proximal direction within the inner assembly .
  • Fig. 37 is a flowchart of method of positioning a biopsy device, according to one enibodimePt.
  • Block B3?3 call fo coupling: biopsy device to a Stereotactic biopsy device assembly comprising at least one capstan assembly,
  • a suitable capstan is shown i Figs. 27AC and Figs, 28A-D.
  • the stereotactic biops device assembly may be configured to couple to a Stage f a stereotactic table.
  • the stereotactic biopsy device assembly may comprise a first portion configured to fixedly couple to the stage and a second portion movaMy coupled to the firs portion.
  • a first capstan assembly may be configured to couple to the second portion of the platform and to the biops device.
  • Block B372 calls for the biopsy device to enter the tissue along the z ⁇ axi j ⁇ whereupon a tissue sample may be obtained, as shown at B373.
  • the capstan assembly may then be operated, as shown at B37 .
  • a ship's wheel (or other type of actuator) of the capstan, assembly may be turned or otherwise actuated either manually or by machine using either Cartesian or polar coordinates, within the degrees of freedom allowed by the capstan assembly.
  • the capsta assembly may be operated entirely mannally, controlled by the user using his or her best ciimcal judgment and skill, optionally u der direct visualization.
  • capstan assemblies may be used to identically or ditleienti i!y raise or lower the distal and/or proximal ' ends of the biopsy device nd to move the biops t a position that is off-center relative to its initial position.
  • The. biopsy device may also be rotated in conjunction, with the Movement imparted thereto by the capstan assembly or assemblies coupled thereto.
  • Fig. 38 is a flowchart, of another tnethod according to One embodiment.
  • Block B381 calls for inserting a biopsy device through art incision in tissue.
  • the inserted biopsy device may comprise an outer element comprising an open scoop wia-shaped distal portion having a sharpened edge, and an inner assembly configured to fit at least partially within the outer element and comprising a tissue coring and parting off assembly.
  • the biopsy device may then be advanced within the tissue to the intended biops site- 8383 calls for coring and parting off the tissue to cut a first tissue specimen front the biops site.
  • At least the outer element may be rotated as shown at B384, while the sharpened edge of the open seoopnla-shaped distal portion cuts through an arc of tissue.
  • the arc of tissue ma y be oriented substantially normal to the long axis of the tissue specimen. That is, according to one embodiment, the open $c3 ⁇ 4opu!a-shaped distal portion may be rotated about its longitudinal ax s (e.g., 14 in Fig. 15B), which is norma! t the long axis of the tissue specimen (shaped like, according t one embodiment, short segments of a ni ' pe, w it tapered proximal an d distal ends ⁇ .
  • tissue specimens After rotating, one or more further tissue specimens ma be cut .from the tissue lacing the open scoopula-shaped distal portion., which lacing tissue may be radially separated from t e tissue from which the previous, pte-rotation specimen was cut.
  • the inserting in Block B3S 1 may be carried out with, the tissue coring and part-off assembly comprising at least one articulated beak element. Coring and parting of , rotating and generating steps may be repeated as desired to generate tissue specimens at least partially "around the clock"; that is, at least partially about 360 degrees of rotation.
  • the tis sue may be caused to prolapse or to prolapse further into the open scoopula-shaped. distal portion after the rotatin step of Block B384.
  • Such may be carried out by, for example, imposing an axially-directed movement on the biopsy device before or after the rotating step.
  • the cut specinien(s) may then be transported within the biopsy device away from the biopsy site.
  • Advancing the biops device within the tissue in Block B3S2 may cause the sharpened edge of the open scoopula-shaped distal portion to dissect tissue along an insertion path.
  • the coring and part ⁇ otF assembly as the coring and part ⁇ otF assembly is advanced such that the distal tip thereof feces the distal tip f the open scoopnta-shaped distal portion, the coring and parting off of the tissue may be carried out with substantially :3 ⁇ 4ero dead space at the distal tip of the biopsy device.
  • the tissue coring and parting off assembly may be, retracted away from the distal tip.
  • a specimen thai is less than the full length of the scoopitla, as well as other purposes.
  • Such advancing, retracting and rotating steps may be carried out stereotactieaiby Of ma be controlled- or carried, out manuall by the nser of the biopsy device.
  • the sharpened edge of tie open scooptila-shaped distal portion may be configured to cut at an angle that is substantially normal (i.e., substantially perpendicular) to a long axis of the specimens .(generally tapered tube-shaped pieces of tissue) cut and collected by the biopsy device.
  • the proximal sheath 300 may be attached to the body portion 428 as well as to- the tendon actuating portion 469 of the monolithic beak assembly 13.
  • the distal sheath 320 may be attached to the proximal sheath 300 at attachment point 326. in this manner, rotation of the distal sheath, will e train the monolithic beak assembly and the proximal sheath 300 in .rotation also or vice versa, depending on the driving taechanism of such embodiments.
  • the rotation for tisane specimen transport is the same as the .rotation for specimen collection using the monolithic beak assembly.
  • the interior lumen of the proximal sheath 300 may be relati vely smooth and as the interior lum thereof may be farther lubricated with flush entering the lumen through aligned fenestrations 304, 324 in the proximal sheath 300 and the distal sheath 320, the tissue specimen may be transported substantially intact (e.g., with the tissue architecture undamaged or not damaged to such degree as to hinder examination), to the transfer magazine 27 or to the proximal end of the interior lumen.
  • proximal sheath 300 are attached t corresponding attachment points 310 on proximal sheath 300, which are attached to the tendon actuating members 469, a distally-directed force applied to the proximal sheath 300 acts to close the beak or beaks of the monolithic beak assembly 13, This is because the tendon actuating members 469 are acted upon by the axial!y stationary distal sheath 320, while the bod portion of the inonolithic beak assembly 13 is held by the proximal sheath 302, at attachment points 30SB, 292B and moved axially forward, causing the beaks to close down via their living hinges.
  • the spring or resilient portions 427 on the monolithic beak, assembly 1 , the spring o resilient portion of the proximal sheath 302 act. in concert to bias the beak or beaks in the open configuration such that* when the distally-direeied forc imparted on. the proximal sheath 300 is released, the beak or beaks of the monolithic beak assembly 13 return to their default open eontigoration. It should be noted that holding the proximal sheath stationary axiaily while exerting a proximal force on the distal sheath will produce an identical beak open/closing mechanism, and may be selected to match with a driving mechanism that will accommodate such action, as ma be envisioned by one skilled in the art
  • the beak may be configured for actuation and cycling between a closed configuration (for penetration and part-off] and an open configuration (for coring and capturing tissue sample) while rotating.
  • Such cycling between closed and open beak configurations ma he accomplished, according to one enihodinient, usin a push-pull mechanism that originates in a driving assembly far proximal to the beak structures themselves.
  • Such a push-pull mechanism between a proximal driver and the movable structures of the beak assembly including movement of living backbone hinge elements relative to living hinge tendon/keystone elements of the beaks, may comprise relatively rigid structures that can transmit small movements precisely, relying on column strength structural integrity combined with reiaiively inelastic tension structures to transmit these direct, linear forces over the length between the distal beaks and the proximal driver mechanism.
  • Such a driving mechanism ma be appropriate for instruments that can rely on relatively short and rigid members between the handle (driver) and the working end.
  • sue h a distal !y-originated beak actuation mechanism is described herein.
  • one embodiment utilizes a ⁇ mechanism that allows significant flexing of the catheter that contacts the driver and the workin distal, end while providing forces that mm be converted to small, precise, repeatable linear -push-pull forces locally - that is, at the distal end very near to keystone and backbone, living , hinge and tendon elements; In so doing, such tel st ve motion causes the distal, beak to cycle between open and closed confi dura ions.
  • fig. 39 shows a twin-beak device, comprising a double beak eoring/part-oif assembly in relationship with a sheath 3902 comprising a distal scoop-shaped open portion 3903 (seoopula), according t one embodiment, fig. 39 shows an inner element comprising an articulable distal assembly 3904.
  • the articulable distal assembly 3904 comprises two articulable -memb rs (beaks) 3906, 3908.
  • the articulable distal beak assembly 3904 comprises a single articulable member 3910. i the embodiments of Figs. 39 and 40, the articulable beak assembly 3904 is disposed in the imtermost position within a middle tabular element 3 1.2.
  • the two beaks 3906, 3908 are shown in distal position where they are about to be cl osed to part-off ti ssue (not shown) through whi ch they have cored white rotating and traveling m a proximal to distal direction in the seoopula, in their wide open configuration.
  • the living backbone (hinge) elerae»t(s) of the articulable distal assembly 3904 is of one . integral structure with its he ical/fesilient component 391 ("threaded” section, nesting m s milar, component in the ffiiddie tubular/helical “threaded” section) and has limited travel ability that Comprises both rotation relative to the middle tubular/helical structure 3916 of the tabular element 3912 and longitudinal (linear, along the long axis of the excisional devke) movement Because the keystone element of the inner element is constrained such that it may only move i a circular slot In the middle tobnlar helical/resilient structure 3916 of the tubular element 391 , which is at a finer pitch (shown here as 90 degrees to the long axis), the articulable distal members) (beak(s)) 3906, 3908, 3910 of the articulable distal assembly 3904 are necessarily open wide
  • the inner-most mbe/hei ix/res lient portion 3914 of the inner element is made to '3 ⁇ 4aich up" while rotating, to the middle nibuiar helicaL/resilient element 3916, thus causing the threaded elements of each of the tubular/helical.' 'resilient components that are threaded with each other, to return to the resting or "closed” configuration and force a linear motion, again based on the fact that the keystone element is constrained to only move at a finer pitch (In this case approximately 90 degrees to the long axis of the roughly tabular elements) than those of the threaded, elements to fully close the articulable distal assembly 3904..
  • a finer pitch In this case approximately 90 degrees to the long axis of the roughly tabular elements
  • Figure 40 shows an embodiment in which the inner element comprises an articulable distal assembly 390 comprising a single articulable member (beak) 3 10 configured to operate based on similar principles and modes of operation as were di scussed above relative -to Fig, 39, in which the articulable distal assembl 3904 of the inner element comprised two (e.g. a first and a second) articulable members (beaks), in the depletion of Fig. 40, the single articulable member (beak) 3 10 is alread at a.
  • the inner element comprises an articulable distal assembly 390 comprising a single articulable member (beak) 3 10 configured to operate based on similar principles and modes of operation as were di scussed above relative -to Fig, 39, in which the articulable distal assembl 3904 of the inner element comprised two (e.g. a first and a second) articulable members (beaks), in the depletion of Fig. 40, the single articul
  • a e&cisional device may comprise a sheath 3902; a tubular element 3912 configured for rotation with the sheath 3902 and an inner element configured for rotation and disposed at least partially within the tubular element 3912.
  • the inner element may comprise an articulable distal assembly 3904 configured to cor® through tissue in an open configuration and part-off cored tissue in a closed configuration.
  • differentia! rotation of the inner element (that comprises the distaily-disposed articulable assembly 3904) with respect to the tubular element 3912 causes the articulable distal assembly 3904 to selectively assume the open and closed configurations
  • the sheath 3902 may comprise a distal scoop-shaped open portion, shown at 3903 in Figs. 39 sad 40.
  • Rotating the inner element comparatively faster than the tubular elemen may cause the. -articulable distal assembl 3904 t assume the closed configuration.
  • rotating the inner element comparativel slower than the tubular elemen 3 1.2 may causes the articulable distal assembly 3904 to assume the open configuration.
  • the articulable distal assembly 3904 may comprise a single articulable member 3 10 that may be configured to bear against the sheath 3902 when the articulable distal assembly 3904 is in the closed configuration
  • the articulable distal assembly 3904 ma comprise a first, articulable member 3906 and a second articulable member 3908.
  • the first and second articulable members 3906, 3908 may be configured to ear against each other when the articul ble distal assembly 3 04 is i the closed configuration.
  • the amount of the ⁇ differential rotation of the inner element with respect to the tubular element 3912 is limited.
  • the artic lable distal assembly 3904 may be mechanically coupled to the tubular element 3912 so .as to allow a limited amount of differential rotation of the tabular element- 3 12 relative to the inne element. This limited amount of differential rotation of the tabular element relative to the inner element, however, is sufficient for the articulable distal assembly 3904 to selectively assume the open and closed configurations.
  • The- inner element may lie configured to comprise a first resilient portion 3914 and the tabular element 3912 may b configured to comprise a second resilient portion 3916 that may be mechanically ⁇ coupled (or at least constrained in its relative movement with respect) to the first resilient portio 3914.
  • -differential rotation of the inner element with respect to the tubular element may comprise the inner element lagging in rotation relative to the tabular -element and/or the inner element leading in rotation relative to the tabular element.
  • Fig, 41 is a flowchart of a method according to one embodiment As show chanein, block; B4l I calls for providing a device eoHtprisJng a sheath, a tubular element configured for rotation within the sheath, and an inner element comprising an articulable distal assembly configured for rotation and disposed -at least: partially within the tubular element Block B4.1.2 calis- for coring through tissue with the articulable distal assembly in an open configuration.
  • the cored tissue may he parted off with the articulable distal assembly in a closed, configuration-
  • 8414 calls for differentially rotating the inner element with respect to the tubular element to selectively control the articulable distal assembly to assume the open (block B 12) and the closed: -configuration, (block B4.13),
  • the coring and transport mechanisms and methods described and sho n, herein are configured to apply traction while coring, as- the bea3 ⁇ 4s) either close against the seoopala. If one beak is used, or against each other if dual beaks are used and are then withdrawn to its or their resting position within the proximal edge of the scoopu!a opening, carrying the tissue specimen with it or them.. That is, coring, cutting, parting-off, traction and transport may be, according to one embodiment, carried out simultaneously. I so doing, as traction is a plied during a cutting event, the cutting event is not only rendered more efficient, hut ma be the only way to successfully cut certain tissue types.
  • This traction is facilitated by the continuous interaction of the helical elements), the tubular coring and transport assembly, and the flush and aspiration, depending on embodiments, which all or separately act together to provide gentle continuous traction beginnin immediately upon die tissue entering the lumen of the tubular coring and transport assembly 11 of Fig. 1 and continuing during part-off of the tissue specimen-
  • the ratio between the twisting and pulling actions may he carefull controlled by, for example, control of rotation versus crank or cam speed, or other axial control mechanism.
  • tissue is drawn in by at least the syffece tfeatajent(s) 5 channels, and helical elements past the sharp beak assembly and into ' the interior lumen of the tubular coring and transport assembly.
  • This may be, according to one embodiment, augmented with either flush or vacuum or both.
  • the transport mechanisms and functionality described herein is more effective limn vacuum alone, as vacuum predominantly acts locally at the proximal surface of a specimen, indeed, the transport mechanisms described and shown herein ⁇ e.g., surfac treatments, rifling, vacuum slot , helical elementCs), and the selective rotation of these) m y be configured to act along the entire length of the sidewalls of the tissue specimen, which may be useful in transporting certain tissue types.
  • Vacuum may well augment such tractio and transport but need not be the primary modality by which tissue specimen are drawn ptoxirna! y or materials are pushed distaily to the target lesion site.
  • vacuum may be used for extracting cells, bod fluids and flush fluids, and to prevent the ⁇ inadvertent injection of outside air, which may obscure an ultrasound image or transfer other unwanted elements into the body ,
  • the present biopsy devic may be farmed! .f or comprise one or more biocoiBpatible materials such as, for example, stainless steel or other biocompatible alloys, and may be made of, comprise or be coated with polymers,, suc as polyimide, ami'or biopolymer materials as needed to optimize funciion(s).
  • the catting elements (such as the constituent elements of the beak assembly 13) may comprise or be made of hardened alloys and may be additionally coated -with slippery material or materials to thereby optimize passage through Irving tissues of a variety of consistencies and frictions.
  • the various gears or pulleys may be made o an suitable, commercially available materials such, as nylons, polymers such as mo!dabie plastics, and others.
  • the motor powering the various powered functions of the present biopsy device may be a commercially available electric DC motor.
  • the handle of the present biopsy device may likewise be made of or comprise inexpensi ve, injection-molded plastic or other suitable rigid, easil hand held strong and light-weight material. The handle may be configured in such a way as to make it.
  • the materials used in- the present biopsy device may also be carefully selected from a er omagnetic standpoint such that the present biopsy device maintains compatibility with RI equipment that is conrnio y used for biopsy procedures.
  • The- vacuum/delivery assembly components may comprise commercially available vacuum pinups, syringes and tubing for cotineciiag to the present biopsy device, along with readily available reed valves for switching between suction and emptying of materials such as fluids, whic may be suctioned by the vacuum components.
  • the fluids collected by the embodiments of the present biopsy device in this manner may then be ejected into an additional external, yet portable, liquid storage vessel connected to the tubing of the- present biopsy device* for di scarding or lot safe keeping for laborator cellular analysis.
  • the power source may comprise an external commercially available AC to
  • DC transformer approved for medic l device use and plugged into the provided socket In the present biopsy device or may comprise an enclosed battery of any suitable and commercially available -power source.
  • the battery may fee of the one-time use disposable (and optionally recyclable) variety, or may be of the rechargeable variety. Additionally, other power sources, for example, mechanical linkages or compressed air motors, ma be used.
  • the cutting beak -assembly of embodiments of the biops devices may be used, without alteration of thei shape, attachment or any other .modification, to penetrate tissue an approach to a target lesion.
  • the cutting beak asse bly then be used to open and core the tissue specimen, and to t reafter part-off the specime at the end of the coring stage.
  • the beak assembly ma also be nsed to hel augment transport of the collected, specimen.
  • an internal helical transport system may be eonfiguredto augment the coring functiono of the forward cutting beaks.
  • the helical, transport coring elements may be configured to appl gentle, predictable traction, on the cored specimen, during and after coring, which permits pairing the ideal speed of longitudinal excursion of f he coring elements of t present biopsy device with the idea! speed of rotational movement of the same decreets, " in this manner, the architecture of the collected specimen is less likely to ' be disrupted during transport, ' It has been shown in peer-reviewed scientific articles that presetting tissue architecture (i.e., preserving the architecture of the tissue as it was in vivo) to the extent possible leads to a easier and more accurate diagnosis.
  • the present vacuum delrv ery mechanism may be configured to enable the force of vacuum to be exerted directly to the coring transport components, such that coring and transport of the specimen is handled as delicately, yet as surely, as possible and comprises noo-signifieantly dimension nereasi «g components such as progressively sized fenestration features within collection magazine areas, if the present biopsy device were to rely solely on vacuum for tissue transport, then vacuum artifact, which is a known and described phenomenon associated with -conventional biopsy devices, might be present to a greater degree than is present (if at all) in -embodiments, described herein.
  • Embodiments comprise a hollow helical transport mechanism that may be both strong and flexible, which continues t function even when distorted by bending.
  • Conventional biopsy device typically cease to function properly if distorted even, slightly..
  • the present biopsy device may be configured to define a curve along its longitudinal mis and would still .function, properly, -with minimal modifications.
  • a biopsy and coring device comprises features configured to perform medical core biopsy procedures or for shaping (such as for vascular applications) or harvesting tissue for other uses.
  • These features comprise structures configured for penetration, coring, part-off, transport and storage of core specimens for medical purposes such as diagnosis and treatment of a variety of diseases and. abnormalities, integral and detachable components may be provided and configured to aspirate fluids for cellular analysis as we ' ll as deliver agents at various selectable stages of the procedure.
  • the present biopsy device may be .selectable, for automatic - and/or semi-automatic function:, may be used with or wi thout image guidance, and may fee comp tible with a variety of g idance ' imagin m ⁇ n nt suc a ultrasound, magnetic resonance imaging and X-ray imaging.
  • the present biops device may be configured ' to be disposable and/or recyclable, highly portable, and delivered for use i sterile packaging, typical of medical devices ' having contact with internal body structures.
  • the present biops device may be configured to be minima l invasive.
  • the presen biops device comprises several features that may be therapeutic in nature, to be utilized at various stages along the diagnosis/treatment pathway.
  • valves on an internal combustion engine may be extremely finely tuned with respect to dynamics such as initial or staged acceleration/deceleration during opening and closing of the valves.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medical Informatics (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pathology (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

La présente invention concerne un dispositif d'excision comprenant une gaine ; un élément tubulaire configuré pour se mettre en rotation, avec la gaine ; et un élément interne configuré pour se mettre en rotation et disposé au moins partiellement à l'intérieur de l'élément tubulaire. L'élément interner peut comprendre un ensemble distal articulable configuré pour pénétrer à travers le tissu dans une configuration ouverte et pour diviser le tissu pénétré dans une configuration fermée. La rotation différentielle de l'élément interne par rapport à l'élément tubulaire amène l'ensemble distal articulable à adopter sélectivement les configurations ouverte et fermée. Par exemple, décaler la rotation de l'élément interne par rapport à la rotation de l'élément tubulaire peut commander l'ensemble distal articulable à l'adoption de la configuration ouverte alors que la conduire de la rotation de l'élément interne par rapport à la rotation de l'élément tubulaire peut commander l'ensemble distal articulable à l'adoption de la configuration fermée.
PCT/US2016/013551 2015-01-17 2016-01-15 Mécanisme et procédé d'actionnement d'extrémité de travail distale de dispositif d'excision WO2016115433A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US14/599,481 2015-01-17
US14/599,481 US10231750B2 (en) 2014-09-29 2015-01-17 Excisional device distal working end actuation mechanism and method

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WO2016115433A1 true WO2016115433A1 (fr) 2016-07-21

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116059466A (zh) * 2023-02-03 2023-05-05 广州市焕思实业有限公司 一种防堵型脉冲冲洗器

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5655542A (en) * 1995-01-26 1997-08-12 Weilandt; Anders Instrument and apparatus for biopsy and a method thereof
US20090306689A1 (en) * 2008-06-05 2009-12-10 Cardiovascular Systems, Inc. Bidirectional expandable head for rotational atherectomy device
US20140336530A1 (en) * 2013-05-09 2014-11-13 Transmed7, Llc Soft tissue coring biopsy devices and methods

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5655542A (en) * 1995-01-26 1997-08-12 Weilandt; Anders Instrument and apparatus for biopsy and a method thereof
US20090306689A1 (en) * 2008-06-05 2009-12-10 Cardiovascular Systems, Inc. Bidirectional expandable head for rotational atherectomy device
US20140336530A1 (en) * 2013-05-09 2014-11-13 Transmed7, Llc Soft tissue coring biopsy devices and methods

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116059466A (zh) * 2023-02-03 2023-05-05 广州市焕思实业有限公司 一种防堵型脉冲冲洗器
CN116059466B (zh) * 2023-02-03 2023-09-12 广州市焕思实业有限公司 一种防堵型脉冲冲洗器

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