US20060200041A1 - Biopsy device incorporating an adjustable probe sleeve - Google Patents

Biopsy device incorporating an adjustable probe sleeve Download PDF

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Publication number
US20060200041A1
US20060200041A1 US11/222,575 US22257505A US2006200041A1 US 20060200041 A1 US20060200041 A1 US 20060200041A1 US 22257505 A US22257505 A US 22257505A US 2006200041 A1 US2006200041 A1 US 2006200041A1
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US
United States
Prior art keywords
cutter
cylindrical tube
side aperture
half cylindrical
distal
Prior art date
Legal status (The legal status 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 status listed.)
Abandoned
Application number
US11/222,575
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English (en)
Inventor
Robert Weikel
Gwendolyn Payne
John Andrisek
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Devicor Medical Products Inc
Original Assignee
Ethicon Endo Surgery Inc
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 US11/072,719 external-priority patent/US7517322B2/en
Priority to US11/222,575 priority Critical patent/US20060200041A1/en
Application filed by Ethicon Endo Surgery Inc filed Critical Ethicon Endo Surgery Inc
Assigned to ETHICON ENDO-SURGERY, INC. reassignment ETHICON ENDO-SURGERY, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: PAYNE, GWENDOLYN PEREZ, ANDRISEK, JOHN R., WEIKEL, JR., ROBERT F.
Priority to CA002538400A priority patent/CA2538400A1/en
Priority to JP2006058398A priority patent/JP4907198B2/ja
Priority to EP06251160A priority patent/EP1698283B1/en
Priority to MXPA06002510A priority patent/MXPA06002510A/es
Priority to BRPI0601016-4A priority patent/BRPI0601016A/pt
Priority to AU2006200950A priority patent/AU2006200950B2/en
Priority to US11/391,805 priority patent/US7481775B2/en
Publication of US20060200041A1 publication Critical patent/US20060200041A1/en
Assigned to DEVICOR MEDICAL PRODUCTS, INC. reassignment DEVICOR MEDICAL PRODUCTS, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: ETHICON ENDO-SURGERY, INC.
Assigned to GENERAL ELECTRIC CAPITAL CORPORATION, AS AGENT reassignment GENERAL ELECTRIC CAPITAL CORPORATION, AS AGENT SECURITY AGREEMENT Assignors: DEVICOR MEDICAL PRODUCTS, INC.
Abandoned legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/0233—Pointed or sharp biopsy instruments
    • A61B10/0266—Pointed or sharp biopsy instruments means for severing sample
    • A61B10/0275—Pointed or sharp biopsy instruments means for severing sample with sample notch, e.g. on the side of inner stylet
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/0233—Pointed or sharp biopsy instruments
    • A61B10/0283—Pointed or sharp biopsy instruments with vacuum aspiration, e.g. caused by retractable plunger or by connected syringe

Definitions

  • tissue samples for subsequent sampling and/or testing are know in the art.
  • a biopsy instrument now marketed under the tradename MAMMOTOME is commercially available from Ethicon Endo-Surgery, Inc. for use in obtaining breast biopsy samples.
  • These generally-known vacuum assisted core biopsy devices include desirable features wherein larger samples are drawn in by vacuum assistance and severed by a cutter. These larger samples have benefits over needle biopsies in obtaining a sample more likely to include at least a portion of a suspicious lesion for diagnostic purposes.
  • some of these known biopsy devices are capable of taking multiple samples without having to remove the probe. This shortens the duration and inconvenience of the procedure between taking samples. In addition, this facilitates taking sufficient samples to fully excise a suspicious lesion.
  • a core biopsy device that is capable of taking biopsies of a suspicious lesion that is proximate to the skin.
  • a core biopsy device has a probe sleeve including a curved portion sized to correspond to a portion of the probe of the core biopsy device surrounding at least the proximal portion of the side aperture which is held thereover by an engaging structure attached to the curved portion and registered to at least partially encompass and engage the probe.
  • a flange attached to the curved portion allows a user to longitudinally position the curved portion over the proximal portion of the side aperture when desired.
  • FIG. 3 is an isometric view of the probe assembly with the left handle shell removed, showing the cutter in the first, fully retracted position, and a tissue sample is own deposited onto a tissue sampling surface of the handle after the tissue sample was moved from the distal end of the cutter;
  • FIG. 4A is a top view in section of the probe assembly and a distal portion of the holster, revealing a cutter in a first, fully retracted position;
  • FIG. 5 is a front view in elevation of the probe and probe sleeve taken in cross section along lines 5 - 5 of FIG. 1 ;
  • FIG. 7C is an isometric view of the probe of the biopsy system of FIG. 1 with the be sleeve at a most distal position completely blocking the side aperture;
  • FIG. 8C is a left side view in elevation of the probe and probe sleeve of FIG. 7B en along a longitudinal centerline of lines 8 - 8 with a completely severed tissue sample captured in the sample lumen;
  • FIG. 9 is a perspective view of an alternative probe sleeve for the core sampling biopsy system of FIG. 1 incorporating a transparent body, measurement indicia and a protective insert to prevent cutter gouging;
  • FIG. 10 is a perspective view of the transparent body of the alternative probe eve of FIG. 9 ;
  • FIG. 12 is a perspective view of an alternative non-ribbed protective insert for the alternative probe sleeve of FIG. 9 ;
  • FIG. 16 is a left side view in elevation of the additional alternative transparent body of FIG. 15 taken in cross section along longitudinal centerline 16 - 16 ;
  • FIG. 17 is a partial isometric and partial schematic view of an alternative biopsy stem that includes a handpiece with a short stroke cutter that is advantageously figured to perform a cutting stroke that blocks a proximal portion of a side aperture of robe for taking biopsy samples near an external surface;
  • FIG. 19A is a cross-sectional isometric view of the probe assembly of FIG. 18 en along line 19 - 19 with a cutter and carriage assembly positioned at a proximal position;
  • FIG. 19B is a cross-sectional isometric view of the probe assembly of FIG. 18 en along line 19 - 19 with the cutter and carriage assembly positioned between proximal distal end positions;
  • FIG. 20 is an exploded isometric view of the probe assembly of FIG. 18 ;
  • FIG. 21A is a schematic left side view in elevation of a probe of the probe assembly of FIG. 18 taken along a longitudinal center line in cross section with a cutter at fully retracted position just proximal to a side aperture of the probe;
  • FIG. 21C is a schematic left side view in elevation of the probe of the probe assembly of FIG. 18 taken along a longitudinal center line in cross section with the cutter fully distally translated with vacuum assist being used to both push and pull a severed sue sample in the cutter proximally;
  • Core sampling biopsy devices are given additional flexibility to remove tissue samples that reside close to an insertion point by incorporating an ability to block a proximal portion of a side aperture in a probe, corresponding to where the outer tissue layers contact the probe when the distal portion of the side aperture is placed beside a suspicious lesion.
  • This proximal blocking feature may be provided by a separate member attachable to generally-known biopsy devices, leveraging existing capital investments in an economical way.
  • a biopsy device that includes a long stroke cutter that retracts fully out of a probe between samples in order to retrieve tissue samples is thus adapted when a variable sized side aperture is desired.
  • a biopsy device that has tissue sample retrieval that is independent of cutter position is adapted to employ the cutter as the proximal blocking feature to achieve a variable sized side aperture.
  • a biopsy system 10 which is described in greater detail in the previously incorporated U.S. Pat. No. 6,273,862, performs a long cutting stroke in combination with vacuum assistance to obtain a plurality of consistently sized core biopsy samples suitable for diagnostic and therapeutic treatments without the necessity of removing a probe (a.k.a. needle, piercer) 12 to retrieve each sample. While retaining a long side aperture (port) 14 in the probe 12 is useful in many instances to retrieve relatively large samples, there are instances in which a suspicious lesion has been imaged proximate to the outer skin. Positioning the probe 12 for such a biopsy would expose a proximal portion of the side aperture 14 outside of the patient's body, defeating pneumatic features of the biopsy system 10 .
  • a proximal aperture blocking member depicted in the illustrative version of FIG. 1 as a probe sleeve 16 , advantageously clips onto the probe 12 and may be distally positioned to selectively cover a proximal portion of the side aperture 14 when desired.
  • the biopsy system 10 includes probe assembly 18 that includes a handle 20 proximally attached to the probe 12 .
  • the biopsy system 10 further includes a detachable holster 22 that serves as a manual user interface and a mechanical and electrical connection to a control module 24 that may be remotely positioned away from diagnostic systems (e.g., magnetic resonance imaging (MRI)) (not shown).
  • the control module 24 includes a fluid collection system 26 , a control unit 28 , and a power transmission source 30 .
  • the handle 20 is detachably connected to the detachable holster 22 . Together they constitute a lightweight, ergonomically shaped, hand manipulatable portion referred to as a biopsy device (“handpiece”) 32 .
  • the handpiece 32 is fluidly connected to the fluid collection system 26 by a first vacuum tube 34 and a second vacuum tube 36 .
  • the first and second vacuum tubes 34 , 36 are detachably connected to the fluid collection system 26 by a first connector 38 and a second connector 40 , respectively.
  • the first connector 38 has a male portion 42 and a female portion 44 attached to the first vacuum tube 34 .
  • the second connector 40 has a female portion 30 and a male portion 26 attached to the second vacuum tube 36 .
  • the connector male and female portions, 42 - 48 are attached in this manner to prevent the accidental switching of the first and second tubes 34 , 36 to the fluid collection system 26 .
  • a first switch 78 , a second switch 80 , and a third switch 82 are mounted in the distal portion of the detachable holster 22 so that the physician can operate the handpiece 32 with a single hand while having the other hand free to operate an ultrasonic imaging device or the like.
  • the switches 78 , 80 , and 82 are provided to operate the power transmission source 30 and the fluid collection system 26 in conjunction with the control unit 28 .
  • a ridge 84 on the distal end of the detachable holster 22 is provided to assist the operator in grasping the handpiece 32 and in operating the switches 78 , 80 , and 82 .
  • the ridge 84 further provides the operator with a tactile reference as to where to properly grasp the handpiece 32 .
  • the handle 20 includes a window 86 so that a portion of the first vacuum tube 34 may be viewed.
  • the first and second vacuum tubes 34 , 36 are made from a flexible, transparent or translucent material, such as silicone tubing. This enables visualization of the material flowing through the tubes 34 , 36 .
  • a transverse opening 88 is provided in the distal end of the hollow handle housing 70 which allows access from either side to a tissue sampling surface 90 . The tissue extracted from the surgical patient is retrieved by the operator or an assistant from the tissue sampling surface 90 .
  • FIG. 2 is an exploded isometric view of the handle 20 .
  • the handle housing 70 is formed from a left handle shell 92 and a right handle shell 94 , each injection molded from a rigid, biocompatible plastic such as polycarbonate.
  • the left and right handle shells 92 , 94 are joined together by ultrasonic welding along ajoining edge 96 , or joined by any of several other methods well known in the art.
  • the probe 12 includes an elongated cutter tube 98 , typically metallic, defining a cutter lumen 100 .
  • the side aperture 14 for receiving the tissue to be extracted from the surgical patient.
  • an elongated, tubular, metallic vacuum chamber tube 102 Joined alongside the cutter tube 98 is an elongated, tubular, metallic vacuum chamber tube 102 defining a vacuum lumen 104 .
  • Cutter lumen 100 is in fluid communication with vacuum lumen 104 via a plurality of vacuum holes 106 located in the bottom of a “bowl” 108 defined by the side aperture 14 . These holes 106 are small enough to remove the fluids but not large enough to allow excised tissue portions to be removed through the first vacuum tube 34 , which is fluidly connected to the vacuum chamber tube 102 .
  • a sharpened, metallic distal end 110 is attached to the distal end of the probe 12 . It is designed to penetrate soft tissue such as the breast.
  • the sharpened distal end 110 is a three-sided, pyramidal-shaped point, although the tip configuration may also have other shapes.
  • An elongated, metallic, tubular cutter 122 is axially aligned within the longitudinal bore 114 of the union sleeve 112 and the cutter lumen 100 of the probe 12 so that the cutter 122 may slide easily in both the distal and proximal directions.
  • a pair of cutter guides 124 are integrally molded into each of the handle shells 92 , 94 to slidably retain the cutter 122 in an coaxially aligned position with the proximal end of the cutter tube 98 .
  • Cutter 122 has a sample lumen 126 through the entire length of the cutter 122 . The distal end of the cutter 122 is sharpened to form a cutter blade 128 for cutting tissue held against the cutter blade 128 as the cutter 122 is rotated.
  • the proximal end of the cutter 122 is attached to the inside of a cutter gear bore 130 of a cutter gear 132 .
  • the cutter gear 132 may be metallic or polymeric, and has a plurality of cutter gear teeth 134 , each tooth having a typical spur gear tooth configuration as is well known in the art.
  • the cutter gear 132 is driven by an elongated drive gear 136 having a plurality of drive gear teeth 106 designed to mesh with the cutter gear teeth 134 .
  • the function of the drive gear 136 is to rotate the cutter gear 132 and the cutter 122 as they translate in both longitudinal directions.
  • the drive gear 136 may be made from a metal such as stainless steel for durability and strength or from a nonferrous material for MRI compatibility.
  • a distal drive axle 138 projects from the distal end of the drive gear 136 and mounts into an axle support rib 140 molded on the inside of the left handle shell 92 .
  • a gear shaft 142 projects from the proximal end of the drive gear 136 and is supported by a gear shaft support rib (not shown) also molded on the inside of the left handle shell 92 .
  • a left cross pin 146 is attached to the proximal end of the gear shaft 142 as a means for rotationally engaging the drive gear 136 .
  • a carriage 148 is provided to hold the cutter gear 132 and to carry the cutter gear 132 as it is rotated in the distal and proximal directions.
  • the carriage 148 is molded from a rigid polymer and is cylindrically shaped with a threaded bore 150 through it and with a carriage foot 152 extending from its side.
  • the foot 152 has a recess 154 formed into it for rotatably holding the cutter gear 132 in the proper orientation for the cutter gear teeth 134 to mesh properly with the drive gear teeth 137 .
  • the carriage 148 is attached via the threaded bore 150 to an elongated screw 156 which is parallel to the drive gear 136 .
  • the screw 156 has a plurality of conventional lead screw threads 158 and may be made from a stainless steel.
  • the rotation of the screw 156 in one direction causes the carriage 148 to move distally, while the reverse rotation of the screw 156 causes the carriage 148 to move proximally.
  • the cutter gear 132 moves distally and proximally according to the direction of the screw rotation, and the cutter 122 is advanced or retracted.
  • the screw 156 is shown with a right hand thread so that clockwise rotation (looking from the proximal to distal direction) causes the carriage 148 to translate in the distal direction. It is also possible to use a left hand thread for the screw 156 as long as provisions are made to do so in the control unit 28 .
  • a distal screw axle 160 and a proximal screw shaft 162 project from the distal and proximal ends, respectively, of the screw 156 .
  • the distal screw axle 160 mounts rotatably in a distal screw support 48 of the right handle shell 94 while the proximal screw shaft 162 mounts rotatably in a proximal screw support 164 , also in the right handle shell 94 .
  • a right cross pin 166 is attached to the proximal end of the screw shaft 162 as a rotational engagement means.
  • FIGS. 2-3 also show the first and second vacuum tubes 34 , 36 referred to earlier.
  • the distal end of the first vacuum tube 34 is attached to a polymeric vacuum fitting 168 that inserts tightly into the transverse opening 118 of the union sleeve 112 . This allows the communication of fluids in the cutter lumen 100 to the fluid collection system 26 .
  • the first vacuum tube 34 is contained within the hollow handle housing 70 in an open space above the screw 156 and drive gear 136 , and exits the distal end of the hollow handle housing 70 through an opening 170 .
  • the second vacuum tube 36 is fluidly attached to the proximal end of an elongated, metallic, tubular tissue remover 172 .
  • the second vacuum tube 36 exits the hollow handle housing 70 alongside the first vacuum tube 34 out the opening 170 .
  • a strainer 174 is attached to the distal end of the tissue remover 172 to prevent the passage of fragmented tissue portions through it and into the fluid collection system 26 .
  • the tissue remover 172 inserts slideably into the tubular cutter 122 .
  • the tissue remover 172 is always stationary and is mounted between a pair of proximal supports 176 on the inside of the left and right handle shells 92 , 94 .
  • the distal end of the tissue remover 172 is approximately even with the distal end of the cutter 122 .
  • the distal end of the cutter 122 when at its first, fully retracted position, is slightly distal to a vertical wall 178 which is proximal and perpendicular to the tissue sampling surface 90 .
  • a right access hole 180 is shown in the proximal end of the right handle shell 43 .
  • the right access hole 180 provides access to the proximal end of the screw 156 for operational engagement to the power transmission source 30 .
  • a left access hole (not shown) is provided in the left handle shell 92 to provide access to the proximal end of the drive gear 136 for operational engagement with the power transmission source 30 .
  • the tissue remover 172 has two functions. First, it helps to evacuate fluids contained in the cutter lumen 100 . This is accomplished by the attachment of the second vacuum tube 36 to the proximal end of the tissue remover 172 . Since the distal end of the tissue remover 172 is inserted into the cutter lumen 100 , the cutter lumen 100 is fluidly connected to the fluid collection system 26 . Second, the tissue remover 172 removes tissue from the cutter 122 as follows. When a tissue sample is taken, the cutter 122 advances to the fourth position just distal to the side aperture 14 , and a severed tissue portion 184 is captured within the sample lumen 126 in the distal end of the cutter 122 .
  • the gear drive shaft 194 is supported rotatably upon a pair of gear drive mounts 208 formed into a first wall 210 and a second wall 212 of the inside of the upper and lower holster shells 64 , 76 .
  • the screw drive shaft 196 is likewise supported rotatably on screw drive mounts 214 .
  • a left coupler 216 is attached to the distal end of the drive gear shaft 194 and has a left coupler mouth 218 for rotational engagement with the left cross pin 146 attached to the gear shaft 142 .
  • the detachable holster 22 further includes a screw rotation sensor 228 , available from Hewlett-Packard as part number HEDR- 81002 P, for providing an electronic signal to the control unit 28 to be described in more detail later.
  • the rotation sensor 228 is mounted within the inside of the holster upper shell 64 and in a position directly above the screw drive shaft 196 .
  • a fluted wheel 230 is attached to the screw drive shaft 196 and extends in front of a light emitting diode (not shown) contained within the rotation sensor 228 .
  • Rotation sensor leads 232 pass through the grommet 198 and are part of the bundle of conductors within the control cord 54 .
  • the detachable holster 22 has the switches 78 , 80 , 82 mounted on the inside of the holster upper shell 64 .
  • the switches 78 , 80 , 82 are electronically connected to a plurality of conductors 234 contained in the control cord 54 .
  • the third switch 82 operates the fluid communication between the handpiece 32 and the fluid collection system 26 and also sets the control unit 28 to respond to various commands;
  • the second switch 80 operates the movement of the cutter 122 in the proximal direction and sets the control unit 28 to respond to various commands;
  • the first switch 78 operates the movement of the cutter 122 in the distal direction and sets the control unit 28 to respond to various commands.
  • the functions of the switches 78 , 80 , 82 are not restricted to what has been described for the first embodiment.
  • the physical locations of the switches 78 , 80 , 82 on the handpiece 32 are not restricted to the locations depicted in FIG. 4 .
  • a distally projecting half tube 314 is attached to the proximal collar 302 and overarches a top portion of the probe 12 with inwardly directed left and right ridges 316 , 318 running along each lateral lower edge of the half tube 314 to longitudinally slidingly engage a pinched lateral waist 320 of the probe 12 .
  • the half tube 314 distally terminates in a beveled edge 322 ( FIG. 6 ) to provide for smoother insertion at the insertion point into tissue, as illustrated in FIGS. 7A-7C wherein the probe sleeve 16 is first proximal to the side aperture 14 ( FIG.
  • FIG. 7A slid over a proximal portion of the side aperture 14 to advantageously enable a biopsy procedure to be performed very close to the surface, ( FIG. 7B ) and then slid further forward to completely block the side aperture 14 ( FIG. 7C ).
  • an alternative probe sleeve 350 includes a transparent body 352 molded from an MRI compatible material.
  • a half cylindrical tube portion 354 of the transparent body 352 distally terminates in an outer ramped surface 356 for atraumatic insertion into an opening into tissue formed by the biopsy device (not shown in FIGS. 9-11 ).
  • the half cylindrical tube portion 354 is shaped to encompass an upper portion of a needle of a biopsy device having a cross section that is a cylindrical, oval, figure-eight shape. It should be appreciated that various internal contours may be used to correspond to a selected needle.
  • an additional alternative probe sleeve 400 is similar if not identical to that depicted in FIG. 10 with several exceptions.
  • a reinforcement portion is omitted for clarity and/or to denote use of a material resistant to gouging from the cutter tube.
  • An aft portion of a shortened half cylindrical tube portion 402 and the left and right horizontal tabs 384 , 386 are omitted aft of the left curved gripping flange 362 .
  • a heightened half oval flange 404 replaces the half circular flange and is paired with a distally spaced second heightened half oval flange 406 for positioning the probe sleeve 400 .
  • Both flanges 404 , 406 are transverse to the half cylindrical tube portion 402 and longitudinally flank the left curved gripping flange 362 .
  • a further alternative probe sleeve 420 formed of a transparent MRI compatible material includes a half cylindrical tube portion 422 with a distal outer ramped portion 424 .
  • Marking indicia 426 are molded along lateral sides of the half cylindrical tube portion 422 .
  • Left and right recesses 428 , 430 and a proximal edge 432 define there between respective left and right curved gripping flanges 434 , 436 that wrap further around the needle to grip.
  • left and right clip levers 438 , 440 that flare upwardly and outwardly respectively from the gripping flanges 434 , 436 . Depressing the clip levers 438 , 440 toward each other pries the respective gripping flanges 434 , 436 outwardly out of engagement with a needle (not shown).
  • First tube 538 may includes a Y connector 542 for connecting to multiple fluid sources.
  • a first proximal end of Y connector 542 may extend to a first solenoid controlled rotary valve 544 in a control module 546
  • the second proximal end of the Y connector 542 may extend to a second solenoid controlled rotary valve 548 in control module 546 .
  • the first solenoid controlled rotary valve 544 in control module 546 may be operable to connect either the vacuum source 536 or a compressed air source 550 to lateral tube 538 . It is understood within this specification that compressed air means air pressure at or above atmospheric pressure.
  • valve 544 when valve 544 is activated, vacuum is supplied to tube 538 from vacuum source 536 , and when valve 544 is not activated, pressurized air from compressed air source 550 is supplied through tube 538 .
  • the solenoid associated with valve 544 may be controlled by a microprocessor 552 in control module 546 , as indicated by dashed line 554 .
  • the microprocessor 552 may be employed to adjust the position of valve 544 automatically based upon the position of a cutter 555 (as shown in FIG. 20 ) movably supported within probe assembly 532 .
  • the second solenoid controlled rotary valve 548 in control module 546 may be employed to either connect a saline supply 556 (such as a saline supply bag, or alternatively, a pressurized reservoir of saline) to a tube 558 or to seal off the proximal end of tube 558 .
  • a saline supply 556 such as a saline supply bag, or alternatively, a pressurized reservoir of saline
  • rotary valve 548 may be activated by microprocessor 552 to supply saline when one of switches 560 on handpiece 530 is actuated.
  • first rotary valve 544 may be automatically deactivated (such as by microprocessor 552 ) to prevent the interaction of vacuum and saline within lateral tube 538 .
  • a stopcock 561 may be included in lateral vacuum tube 538 to allow for a syringe injection of saline directly into the tube 538 , if desired.
  • a syringe injection may be employed to increase the saline pressure in the tube to dislodge any clogs that may occur, such as tissue clogging fluid passageways.
  • axial vacuum tube 540 may be employed to communicate vacuum from source 536 to probe assembly 532 through a tissue storage assembly 562 .
  • Axial tube 540 may provide vacuum through the cutter 555 within probe assembly 532 to assist in prolapsing tissue into a side aperture 564 prior to cutting. After cutting occurs, the vacuum in axial tube 540 may be employed to help draw a severed tissue sample from probe assembly 532 and into tissue storage assembly 562 , as will be described in further detail below.
  • Holster 534 may include a control cord 566 for operationally connecting handpiece 530 to control module 546 , and a flexible rotatable shaft 568 connecting the holster 534 to a drive motor 570 .
  • a power source 572 may be employed to provide energy to control module 546 for powering holster 534 via control cord 566 .
  • Switches 560 are mounted on holster upper shell 574 to enable an operator to use handpiece 530 with a single hand. One-handed operation allows the operator's other hand to be free, for example, to hold an ultrasonic imaging device.
  • Switches 560 may include a two-position rocker switch 576 for manually actuating the motion of the cutter 555 (e.g.
  • FIG. 18 shows probe assembly 532 disconnected from holster 534 .
  • Probe assembly 532 includes an upper shell 580 and a lower shell 582 , each of which may be injection molded from a rigid, biocompatible plastic, such as a polycarbonate.
  • upper and lower shells 580 , 582 may be joined together along a joining edge 584 by any of a number of methods well- known for joining plastic parts, including, without limitation, ultrasonic welding, snap fasteners, interference fit, and adhesive joining.
  • Needle 588 comprises an elongated, metallic cannula 590 , which may include an upper cutter lumen 592 for receiving the cutter 555 and a lower vacuum lumen 594 for providing a fluid and pneumatic passageway.
  • Cutter 555 may be disposed within cannula 590 , and may be coaxially disposed within cutter lumen 592 .
  • Cannula 590 may have any suitable cross-sectional shape, including a circular or oval shaped cross-section. Adjacent and proximal of the distal end of cannula 590 is the side aperture 564 for receiving the tissue to be severed from the patient.
  • the sharpened tip of needle 588 may be formed by a separate endpiece 596 attached to the distal end of cannula 590 .
  • the sharpened tip of endpiece 596 may be used to pierce the patient's skin that the side tissue receiving port may be positioned in the tissue mass to be sampled.
  • piece 596 may have a two-sided, flat-shaped point as shown, or any number of other shapes suitable for penetrating the soft tissue of the patient.
  • the proximal end of needle 588 may be attached to a union sleeve 598 having a longitudinal bore 600 therethrough, and a transverse opening 602 into a widened center portion of the bore 600 .
  • the distal end of lateral tube 538 may be inserted to fit tightly into transverse opening 602 of union sleeve 598 . This attachment allows the communication of fluids (gas or liquid) between the lower vacuum lumen 594 and the lateral tube 538 .
  • the cutter 555 which may be an elongated, tubular cutter, may be disposed at least partially within upper cutter lumen 592 , and may be supported for translation and rotation within cutter lumen 592 .
  • Cutter 555 may be supported within vacuum lumen 594 so as to be translatable in both the distal and proximal directions.
  • Cutter 555 may have a sharpened distal end 606 for cutting tissue received in upper cutter lumen 592 through side aperture 564 .
  • the cutter 555 may be formed of any suitable material, including without limitation a metal, a polymer, a ceramic, or a combination of materials.
  • Cutter 555 may be translated within cutter lumen 592 by a suitable cutter drive assembly 607 such that distal end 606 travels from a position proximal of the side aperture 564 (illustrated in FIG. 19A ) to a position distal of side aperture 564 (illustrated in FIG. 19C ), in order to cut tissue received in cutter lumen 592 through the side aperture 564 .
  • a suitable cutter drive assembly 607 such that distal end 606 travels from a position proximal of the side aperture 564 (illustrated in FIG. 19A ) to a position distal of side aperture 564 (illustrated in FIG. 19C ), in order to cut tissue received in cutter lumen 592 through the side aperture 564 .
  • an exterior cutter (not shown) may be employed, with the exterior cutter sliding coaxially with an inner cannular needle, and the inner needle may include a side tissue receiving port.
  • Union sleeve 598 is supported between probe upper and lower shells 580 , 582 to ensure proper alignment between cutter 555 and the union sleeve 598 .
  • the cutter 555 may be a hollow tube, with a sample lumen 608 extending axially through the length of cutter 555 .
  • the proximal end of cutter 555 may extend through an axial bore of a cutter gear 610 .
  • Cutter gear 610 may be metallic or polymeric, and includes a plurality of cutter gear teeth 612 .
  • Cutter gear 610 may be driven by a rotary drive shaft 614 having a plurality of drive gear teeth 616 designed to mesh with cutter gear teeth 612 .
  • Drive gear teeth 616 may extend along the length of drive shaft 614 so as to engage cutter gear teeth 612 as the cutter 555 translates from a proximal most position to a distal most position, as illustrated in FIGS. 19A-19C .
  • Drive gear teeth 616 may be in continual engagement with cutter gear teeth 612 to rotate cutter 555 whenever drive shaft 614 is rotatably driven.
  • Drive shaft 614 rotates cutter 555 as the cutter advances distally through side aperture 564 for the cutting of tissue.
  • Drive shaft 614 may be injection molded from a rigid engineered plastic such as liquid crystal polymer material or, alternatively, could be manufactured from a metallic or non-metallic material.
  • Drive shaft 614 includes a first axial end 620 extending distally from the shaft 614 .
  • Axial end 612 is supported for rotation within probe lower shell 582 , such as by a bearing surface feature 622 molded on the inside of the probe shells 580 , 582 .
  • a second axial end 624 extends proximally from rotary drive shaft 614 and is supported in a second bearing surface feature 626 , which may also be molded on the inside of probe lower shell 582 .
  • An 0 -ring and bushing may be provided on each axial end 620 , 624 to provide rotational support and audible noise dampening of the shaft 614 when rotary drive shaft 614 is mounted in probe lower shell 582 .
  • a drive carriage 634 is provided in probe assembly 532 to hold cutter gear 610 , and carry the cutter gear and attached cutter 555 during translation in both the distal and proximal directions.
  • Drive carriage 634 may be molded from a rigid polymer and has a cylindrically-shaped bore 636 extending axially therethrough.
  • a pair of J-shaped hook extensions 640 extend from one side of drive carriage 634 .
  • Hook extensions 640 rotatably support cutter 555 on either side of cutter gear 610 to provide proximal and distal translation of the cutter gear 610 and cutter 555 during proximal and distal translation of drive carriage 634 .
  • Hook extensions 640 align cutter 555 and cutter gear 610 in the proper orientation for cutter gear teeth 612 to mesh with drive gear teeth 616 .
  • Drive carriage 634 is supported on a translation shaft 642 .
  • Shaft 642 is supported generally parallel to cutter 555 and rotary drive shaft 614 .
  • Rotation of the translation shaft 642 provides translation of the drive carriage 634 (and so also cutter gear 610 and cutter 555 ) by employing a lead screw type drive.
  • Shaft 642 includes an external lead screw thread feature, such as lead screw thread 644 , on its outer surface.
  • the screw thread 644 extends into the bore 636 in drive carriage 634 .
  • the screw thread 644 engages an internal helical threaded surface feature(not shown) provided on the inner surface of bore 636 . Accordingly, as shaft 642 is rotated, the drive carriage 634 translates along the threaded feature 644 of the shaft 642 .
  • drive carriage 634 (and cutter 555 ) will continue to “freewheel”, with the distal end of cutter 555 translating a short distance proximally and distally as the carriage is alternately biased onto thread 644 by spring 650 a or 650 b and then run off screw thread 644 by rotation of shaft 642 .
  • spring 650 b will engage drive carriage 634 , and repeatedly urge drive carriage 634 back into engagement with screw thread 644 when drive carriage 634 runs off screw thread 644 .
  • the zero pitch width ends of lead screw thread 644 provide a defined stop for the axial translation of cutter 555 , thereby eliminating the need to slow drive carriage 634 (i.e. cutter 555 ) as it approaches the distal and proximal ends of the thread.
  • This defined stop reduces the required positioning accuracy for drive carriage 634 relative to shaft 642 , resulting in reduced calibration time at the initialization of a procedure.
  • the freewheeling of drive carriage 634 at the distal and proximal most positions of translation shaft 642 eliminates the need to rotate shaft 642 a precise number of turns during a procedure. Rather, translation shaft 642 only needs to translate at least a minimum number of turns to insure drive carriage 634 has translated the entire length of lead screw thread 644 and into the zero width thread.
  • a non-rotating rear tube 652 may be provided in which tube 652 may extend proximally from the proximal end of cutter 555 just proximal of cutter gear 610 .
  • Rear tube 652 may be hollow, may have substantially the same inner diameter as cutter 555 , and may be comprised of the same material as cutter 555 .
  • a seal 654 may be positioned between cutter 555 and rear tube 652 to enable cutter 555 to rotate relative to rear tube 652 while providing a pneumatic seal between rear tube 652 and cutter 555 .
  • a rear lumen 656 may extend through the length of tube 652 and may be aligned with sample lumen 608 in cutter 555 .
  • a lateral extension 658 may be provided and may be supported by and extend distally from rear tube 652 for securing the tube 652 to drive carriage 634 .
  • the extension 658 connects tube 652 to drive carriage 634 so that tube 652 translates with cutter 555 , and maintains lumens 608 , 656 in continuous fluid-tight communication throughout the cutting cycle.
  • FIGS. 21A - 21C provide simplified schematic views of the movement of cutter 555 during a cutting cycle of the biopsy system 510 .
  • cutter 555 is located at a distal-most position with distal cutting end 606 disposed distally of the distal most edge of the side aperture 564 . This position is similar to when the probe assembly 532 is being prepared for insertion.
  • the cutter 555 With the probe assembly 532 thus positioned, the cutter 555 is retracted a preprogrammed amount, as shown in FIG. 21B . Thereby, the effective side aperture dimension is variably reduced as desired for taking a smaller length sample.
  • the probe (needle) 588 has been inserted to point where an external surface 672 of body tissue 673 encompasses a proximal blocked portion 674 of the side aperture 564 with a distal unblocked portion 675 of the side aperture adjacent to a suspicious lesion 676 .
  • a lateral vacuum force (indicated by arrow 677 ) may be provided in lower vacuum lumen 594 .
  • Vacuum force 677 may be transmitted from vacuum source 536 through tube 538 to lower vacuum lumen 594 through a flow path provided by union sleeve 598 (not shown in FIG. 21B ). This vacuum force 677 maintains a portion of the suspicious lesion 676 in a prolapsed position inside of the bowl 671 for cutting.
  • Microprocessor 552 may be employed to activate valve 544 to supply vacuum force 682 when switch 576 is actuated by the user to begin moving cutter 555 distally within needle 588 .
  • Lateral vacuum force 682 communicates with side aperture 564 through fluid passageways 678 disposed under side aperture 564 , and through one or more fluid passageways 679 disposed distally of the side aperture 564 .
  • Lateral vacuum force 677 may be employed in combination with an axial vacuum force 680 through sample lumen 608 to draw a tissue sample 682 into side aperture 564 .
  • cutter 555 may be rotated and simultaneously translated distally to sever the tissue sample 682 from the surrounding tissue. While cutter 555 advances, vacuum forces 677 , 680 may be maintained through lower vacuum lumen 594 and sample lumen 608 to draw the tissue sample 682 into the sample lumen 608 as the sample 682 is severed. As shown in FIG. 21B , as cutter 555 advances the cutter 555 slides across fluid passageways 678 , successively blocking the lateral vacuum 677 through fluid passageways 678 .
  • the solenoid on rotary valve 544 may be deenergized or otherwise controlled by microprocessor 552 to replace lateral vacuum force 677 with forward pressurized air (either atmospheric or greater) as shown by the arrows 682 in FIG. 21 C .
  • the pressurized air is discharged through lateral tube 538 to vacuum lumen 594 .
  • the pressurized air communicates with upper cutter lumen 592 through fluid passageway 679 to apply a force against the distal face of sample 682 .
  • the “push” force acting on the distal face of sample 682 may act in combination with “pull” axial vacuum force 680 provided through sample lumen 608 of cutter 555 to move sample 682 into and through sample lumen 608 of cutter 555 , as shown in FIG. 21 C .
  • a pressurized liquid such as saline, may be directed through lower vacuum lumen 594 and fluid passageways 679 to provide the force on the distal face of sample 682 .
  • the cutter 555 closes side aperture 564 from the flow of fluid (gas or liquid) so that tissue surrounding the outer cannula and side aperture 564 is not exposed to the fluid.
  • cutter 555 may be maintained in a distal most position. Alternatively, cutter 555 may be retracted back through side aperture 564 towards its initial position in preparation for the next cutting cycle. After cutter 555 is retracted to its partially blocking position, and the tissue sample is translated to tissue storage assembly 562 , lateral vacuum force 677 is again provided via vacuum lumen 594 to draw the next tissue sample into side aperture 564 . During the translation of cutter 555 , cutter 555 may operate in conjunction with divider 670 to separate cutter lumen 592 from vacuum lumen 594 .
  • cutter 555 translates from a point selectively either just proximal of side tissue receiving side aperture 564 or in the partially blocking position to a point just distal of side aperture 564 .
  • the severed tissue samples 682 are directed through the length of sample lumen 608 of cutter 555 and out of the proximal end of cutter 555 , rather than translating with cutter 555 (with the samples carried in the distal end of the cutter) proximally through needle 588 to eject samples 682 with a knock-out pin, as in some prior devices. Accordingly, the cutting stroke length may be reduced to be just slightly longer than the length of the side aperture 564 . With the reduced stroke 25 .
  • the biopsy system 510 advantageously supports an effectively reduced side aperture mode when desired.
  • the reduced proximal travel of cutter 555 allows biopsy system 510 to be used on patients where the breast is compressed to a thin cross-section. Under these circumstances, biopsy needle 588 is inserted into the breast and the proximal end of side aperture 564 is not within the breast.
  • the reduced cutter translation length effectively reduces the length of side aperture 564 preventing the sharp distal edge 606 of cutter 555 from contacting the patient's skin during each sampling cycle.
  • the reduced cutter translation length may be preprogrammed into the microprocessor 552 located in control module 546 by the user before or during the procedure.
  • a probe 712 for the probe assemblies 18 , 532 advantageously includes a piercing tip 720 having a reduced longitudinal length (e.g., approximately 2 mm shorter) than generally-known piercing tips so as to reduce the “dead space” to a distal end 722 of a side aperture 724 in a cutter lumen 726 .
  • Generally known dead spaces are often about 8 mm. Thereby, lesions close to the chest wall or the medial side of the breast may be sampled without piercing as far beyond the lesion.
  • the piercing tip 720 may be a flat blade as depicted or a pyramidal tip, a rounded cone with needle point, orthogonally crossing flat blades or other shapes.
  • a piercing tip with a reduced longitudinal length may be incorporated into a obturator that extends out of a sleeve having an open distal end.
  • the obturator is removed and replaced with either a blunt ended stylus or a probe of a biopsy device.
  • the blunt distal end thereof may be distally moved to occupy the location previously occupied by the piercing tip to closely approach a skin or chest wall barrier.
  • a proximal blocking feature for a side aperture of a core sampling biopsy device may be integral to a probe rather than being a detachable sleeve nor a selectable position of the cutter.
  • a guillotine door may be slidably attached to the probe, either externally or internally to the probe and either manually positioned or remotely controlled from a handle of the device as desired to shorten the side aperture.

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US11/222,575 2005-03-04 2005-09-09 Biopsy device incorporating an adjustable probe sleeve Abandoned US20060200041A1 (en)

Priority Applications (8)

Application Number Priority Date Filing Date Title
US11/222,575 US20060200041A1 (en) 2005-03-04 2005-09-09 Biopsy device incorporating an adjustable probe sleeve
CA002538400A CA2538400A1 (en) 2005-03-04 2006-03-01 Biopsy device incorporating an adjustable probe sleeve
JP2006058398A JP4907198B2 (ja) 2005-03-04 2006-03-03 調節可能なプローブスリーブを備えた生検装置
EP06251160A EP1698283B1 (en) 2005-03-04 2006-03-03 Adjustable probe sleeve for use with a biopsy device
MXPA06002510A MXPA06002510A (es) 2005-03-04 2006-03-03 Dispositivo para biopsias que incorpora una manga de la sonda ajustable.
BRPI0601016-4A BRPI0601016A (pt) 2005-03-04 2006-03-06 dispositivo de biópsia incorporando uma luva de sonda ajustável
AU2006200950A AU2006200950B2 (en) 2005-03-04 2006-03-06 Biopsy device incorporating an adjustable probe sleeve
US11/391,805 US7481775B2 (en) 2005-03-04 2006-03-29 Biopsy device incorporating an adjustable probe sleeve

Applications Claiming Priority (2)

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US11/072,719 US7517322B2 (en) 2005-03-04 2005-03-04 Biopsy device with variable side aperture
US11/222,575 US20060200041A1 (en) 2005-03-04 2005-09-09 Biopsy device incorporating an adjustable probe sleeve

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US11/072,719 Continuation-In-Part US7517322B2 (en) 2005-03-04 2005-03-04 Biopsy device with variable side aperture

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US11/391,805 Continuation-In-Part US7481775B2 (en) 2005-03-04 2006-03-29 Biopsy device incorporating an adjustable probe sleeve

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US20060200041A1 true US20060200041A1 (en) 2006-09-07

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US11/222,575 Abandoned US20060200041A1 (en) 2005-03-04 2005-09-09 Biopsy device incorporating an adjustable probe sleeve
US11/391,805 Expired - Fee Related US7481775B2 (en) 2005-03-04 2006-03-29 Biopsy device incorporating an adjustable probe sleeve

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EP (1) EP1698283B1 (pt)
JP (1) JP4907198B2 (pt)
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CA (1) CA2538400A1 (pt)
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EP1698283A1 (en) 2006-09-06
BRPI0601016A (pt) 2006-11-07
AU2006200950B2 (en) 2011-10-06
US20060200042A1 (en) 2006-09-07
MXPA06002510A (es) 2006-09-14
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AU2006200950A1 (en) 2006-09-21
US7481775B2 (en) 2009-01-27

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