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

Abstract

A biopsy device and method are provided for obtaining a tissue sample, such as a breast tissue biopsy sample. The biopsy device may include an outer cannula having a distal piercing tip, a cutter lumen, a side tissue port communicating with the cutter lumen, and at least one fluid passageway disposed distally of the side tissue port. The inner cutter may be advanced in the cutter lumen past the side tissue port to sever a tissue sample. After the tissue sample is severed, and before the inner cutter is retracted proximally of the side tissue port, the cutter may be used to alternately cover and uncover the fluid passageway disposed distally of the side tissue.

Description

CROSS REFERENCE TO RELATED APPLICATIONS
• This application is a continuation-in-part to U.S. pat. application Ser. No. 11/072,719 entitled “BIOPSY DEVICE WITH VARIABLE SIDE APERTURE” to Weikel et al., filed 04 -Mar.-2005, the disclosure of which is hereby incorporated by reference in its entirety.
FIELD OF THE INVENTION
• The present invention relates in general to biopsy devices, and more particularly to biopsy devices having a cutter for severing tissue.
BACKGROUND OF THE INVENTION
• The diagnosis and treatment of tissue is an ongoing area of investigation. Medical devices for obtaining tissue samples for subsequent sampling and/or testing are know in the art. For instance, a biopsy instrument now marketed under the tradename MAMMOTOME is commercially available from Ethicon Endo-Surgery, Inc. for use in obtaining breast biopsy samples.
• The following patent documents disclose various biopsy devices and are incorporated herein by reference in their entirety: U.S. Pat. No. 6,273,862 issued Aug.14, 2001; U.S. Pat. No. 6,231,522 issued May 15, 2001; U.S. Pat. No. 6,228,055 issued May 8, 2001; U.S. Pat. No. 6,120,462 issued Sep. 19, 2000; U.S. 6,086,544 issued Jul. 11, 2000; U.S. 6,077,230 issued Jun. 20, 2000; U.S. Pat. No. 6,017,316 issued Jan. 25, 2000; U.S. Pat. No. 6,007,497 issued Dec. 28, 1999; U.S. Pat. No. 5,980,469 issued Nov. 9, 1999; U.S. Pat. No. 5,964,716 issued Oct. 12, 1999; U.S. Pat. No. 5,928,164 issued Jul. 27, 1999; U.S. Pat. No. 5,775,333 issued Jul. 7, 1998; U.S. Pat. No. 5,769,086 issued Jun. 23, 1998; U.S. Pat. No. 5,649,547 issued Jul. 22, 1997; U.S. Pat. No. 5,526,822 issued Jun. 18 1996, U.S. Patent Application 2003/0199753 published Oct. 23, 2003 to Hibner et al.; U.S. patent application Ser. No. 10/676,944, “Biopsy Instrument with Internal Specimen Collection Mechanism” filed Sep. 30, 2003 in the name of Hibner et al.; and U.S. patent application Ser. No. 10/732,843, “Biopsy Device with Sample Tube” filed Dec. 10, 2003 in the name of Cicenas et al.
• 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. In addition, 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.
• Long side apertures of a probe of these biopsy devices in combination with vacuum assistance, especially with a separate vacuum lumen, have many desirable features. However, there are situations in which lesions near the skin are difficult to biopsy with a core biopsy probe. This is more often a challenge with a small breast, especially when compressed in a localization fixture that limits the choice in access direction. If the side aperture of the probe is partially exposed, then vacuum assist may be ineffective as the specimen bowl in the probe is exposed to atmospheric pressure. Further, skin may prolapse into the specimen bowl before the cutter advances into the tissue, causing gouging of the skin, increasing post-procedure pain and scarring.
• Consequently, a significant need exists for a core biopsy device that is capable of taking biopsies of a suspicious lesion that is proximate to the skin.
SUMMARY OF THE INVENTION
• The present invention addresses these and other problems of the prior art by providing a core biopsy device having a probe assembly with a side aperture that is selectively longitudinally sized for taking samples. A proximal blocking member may be selectively positioned proximate to the side aperture such that a proximal portion thereof is blocked when otherwise an outer layer of skin would prolapse into the side aperture when a cutter tube is retracted and then be gouged as the cutter is advanced to take a tissue sample. Thereby, discomfort and disfiguring scarring is avoided while still retaining the ability to take a tissue sample of a lesion near to a patient's skin.
• In one aspect consistent with other aspects of the invention, a device for use with a core biopsy includes a curved portion sized to correspond to a portion of the probe 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 for a user to longitudinally position the curved portion over the proximal portion of the side aperture when desired. Thereby, an additional capability is provided for a biopsy device even when its operation requires that a cutter tube fully retract to remove a tissue sample before a subsequent translation for taking another sample.
• In another aspect of the invention, a transparent sleeve probe.is attachable to a needle of a biopsy device and includes a distal inner contour that helps to prevent gouging by an advancing cutter tube so that debris is not introduced into tissue or into the side aperture of the biopsy device.
• In yet a further aspect of the invention, 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. Thereby, an additional capability is provided for a biopsy device even when its operation requires that a cutter tube fully retract to remove a tissue sample before a subsequent translation for taking another sample.
• These and other objects and advantages of the present invention shall be made apparent from the accompanying drawings and the description thereof.
BRIEF DESCRIPTION OF THE DRAWINGS
• While the specification concludes with claims particularly pointing out and distinctly claiming the present invention, it is believed the same will be better understood by reference to the following description, taken in conjunction with the accompanying drawings in which:
• FIG. 1 is a partial isometric and partial schematic view of a core sampling biopsy system with a handpiece having a long stroke cutter for the collection of soft tissue depicted with a holster separated from a probe assembly;
• FIG. 2 is an exploded isometric view of the probe assembly ofFIG. 1;
• 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. 4 is an exploded isometric view of the holster;
• 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 lines5-5 ofFIG. 1;
• FIG. 6 is an isometric view of the probe sleeve ofFIG. 1.
• FIG. 7A is an isometric view of the probe of the biopsy system ofFIG. 1 with the be sleeve at a proximal position exposing a side aperture;
• FIG. 7B is an isometric view of the probe of the biopsy system ofFIG. 1 with the be sleeve at a more distal position partially blocking the side aperture;
• FIG. 7C is an isometric view of the probe of the biopsy system ofFIG. 1 with the be sleeve at a most distal position completely blocking the side aperture;
• FIG. 8A is a left side view in elevation of the probe and probe sleeve ofFIG. 7B en along a longitudinal centerline of lines8-8 with vacuum assistance being employed prolapse tissue into a bowl of the probe;
• FIG. 8B is a left side view in elevation of the probe and probe sleeve ofFIG. 7B en along a longitudinal centerline of lines8-8 with vacuum assistance being employed prolapse tissue into a bowl and to draw severed tissue into a sample lumen as a cutter e is rotated and translated in a cutter lumen of the probe;
• FIG. 8C is a left side view in elevation of the probe and probe sleeve ofFIG. 7B en along a longitudinal centerline of lines8-8 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 ofFIG. 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 ofFIG. 9;
• FIG. 11 is a perspective view of the ribbed protective insert for the alternative be sleeve ofFIG. 9;
• FIG. 12 is a perspective view of an alternative non-ribbed protective insert for the alternative probe sleeve ofFIG. 9;
• FIG. 13 is a perspective view of an alternative transparent body having paired transverse gripping flanges for a further alternative probe sleeve;
• FIG. 14 is a perspective view of a further alternative transparent body having red radial clip flanges and molded measurement indicia for a yet a further alternative be sleeve;
• FIG. 15 is a perspective view of an additional alternative transparent body having increased diameter distal portion for an additional alternative probe sleeve;
• FIG. 16 is a left side view in elevation of the additional alternative transparent body ofFIG. 15 taken in cross section along longitudinal centerline16-16;
• 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. 18 is an isometric view of a probe assembly of the handpiece ofFIG. 17 h a holster removed;
• FIG. 19A is a cross-sectional isometric view of the probe assembly ofFIG. 18 en along line19-19 with a cutter and carriage assembly positioned at a proximal position;
• FIG. 19B is a cross-sectional isometric view of the probe assembly ofFIG. 18 en along line19-19 with the cutter and carriage assembly positioned between proximal distal end positions;
• FIG. 19C is a cross-sectional isometric view of the probe assembly ofFIG. 18 en along line19-19 with the cutter and carriage assembly positioned at the distal end position;
• FIG. 20 is an exploded isometric view of the probe assembly ofFIG. 18;
• FIG. 21A is a schematic left side view in elevation of a probe of the probe assembly ofFIG. 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. 21B is a schematic left side view in elevation of the probe of the probe assembly ofFIG. 18 taken along a longitudinal center line in cross section with the cutter a partially blocking position within a bowl of the probe below the side aperture, the posed cutter being used to seal an insertion point into tissue as vacuum assist is used to lapse tissue into the distal portion of the side aperture;
• FIG. 21C is a schematic left side view in elevation of the probe of the probe assembly ofFIG. 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; and
• FIG. 22 is a left side view in elevation of a distal end of a probe for the probe assemblies ofFIGS. 1 and 17 with a reduced length piercing tip.
DETAILED DESCRIPTION OF THE INVENTION
• 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. In the first illustrative version, 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. Alternatively, in a second illustrative version, 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.
• Long Stroke Biopsy Device:
• InFIGS. 1-3, abiopsy system10, 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 theprobe12 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 theprobe12 for such a biopsy would expose a proximal portion of theside aperture14 outside of the patient's body, defeating pneumatic features of thebiopsy system10. In addition, it should be appreciated that subsequent cutting strokes may gouge away portions of the skin that may prolapse into theside aperture14, unnecessarily increasing discomfort and scarring at the point of insertion. Advantageously, a proximal aperture blocking member, depicted in the illustrative version ofFIG. 1 as aprobe sleeve16, advantageously clips onto theprobe12 and may be distally positioned to selectively cover a proximal portion of theside aperture14 when desired.
• Thebiopsy system10 includesprobe assembly18 that includes ahandle20 proximally attached to theprobe12. Thebiopsy system10 further includes adetachable holster22 that serves as a manual user interface and a mechanical and electrical connection to acontrol module24 that may be remotely positioned away from diagnostic systems (e.g., magnetic resonance imaging (MRI)) (not shown). Thecontrol module24 includes afluid collection system26, acontrol unit28, and apower transmission source30. Thehandle20 is detachably connected to thedetachable holster22. Together they constitute a lightweight, ergonomically shaped, hand manipulatable portion referred to as a biopsy device (“handpiece”)32. Thehandpiece32 is fluidly connected to thefluid collection system26 by afirst vacuum tube34 and asecond vacuum tube36. The first andsecond vacuum tubes34,36 are detachably connected to thefluid collection system26 by afirst connector38 and asecond connector40, respectively. Thefirst connector38 has amale portion42 and afemale portion44 attached to thefirst vacuum tube34. Thesecond connector40 has afemale portion30 and amale portion26 attached to thesecond vacuum tube36. The connector male and female portions,42-48, are attached in this manner to prevent the accidental switching of the first andsecond tubes34,36 to thefluid collection system26. Thedetachable holster22 includes a firstrotatable shaft50, a secondrotatable shaft52, and acontrol cord54. The first and secondrotatable shafts50,52 are advantageously flexible so that the operator may easily manipulate thehandpiece32 with one hand. Thecontrol cord54 operatively connects thehandpiece32 to thepower transmission source30 andcontrol unit28.
• Thedetachable holster22 and thehandle20 are separated in this depiction for clarity, although it would be appreciated that they would be assembled during operation. A pair oftabs60,62 project laterally from each side of a holsterupper shell64, and insert into left and right undercutledges66,68 of ahollow handle housing70 of thehandle20. A plurality ofindentations72 are provided on thehollow handle housing70 to improve the operator's grip on thehandpiece32. Atube slot74 in alower shell76 of theholster22 provides clearance for first andsecond vacuum tubes34,36. Afirst switch78, asecond switch80, and athird switch82 are mounted in the distal portion of thedetachable holster22 so that the physician can operate thehandpiece32 with a single hand while having the other hand free to operate an ultrasonic imaging device or the like. Theswitches78,80, and82 are provided to operate thepower transmission source30 and thefluid collection system26 in conjunction with thecontrol unit28. Aridge84 on the distal end of thedetachable holster22 is provided to assist the operator in grasping thehandpiece32 and in operating theswitches78,80, and82. Theridge84 further provides the operator with a tactile reference as to where to properly grasp thehandpiece32.
• Thehandle20 includes awindow86 so that a portion of thefirst vacuum tube34 may be viewed. The first andsecond vacuum tubes34,36 are made from a flexible, transparent or translucent material, such as silicone tubing. This enables visualization of the material flowing through thetubes34,36. By having thewindow86 in thehandle20, the operator can see the flow in thefirst vacuum tube34 without needing to look away from the tissue into which theprobe12 is inserted. Atransverse opening88 is provided in the distal end of thehollow handle housing70 which allows access from either side to atissue sampling surface90. The tissue extracted from the surgical patient is retrieved by the operator or an assistant from thetissue sampling surface90.
• FIG. 2 is an exploded isometric view of thehandle20. Thehandle housing70 is formed from aleft handle shell92 and aright handle shell94, each injection molded from a rigid, biocompatible plastic such as polycarbonate. Upon final assembly of thehandle20, the left andright handle shells92,94 are joined together by ultrasonic welding alongajoining edge96, or joined by any of several other methods well known in the art.
• Theprobe12 includes anelongated cutter tube98, typically metallic, defining acutter lumen100. On the side of the distal end of thecutter tube98 is theside aperture14 for receiving the tissue to be extracted from the surgical patient. Joined alongside thecutter tube98 is an elongated, tubular, metallicvacuum chamber tube102 defining avacuum lumen104.Cutter lumen100 is in fluid communication withvacuum lumen104 via a plurality of vacuum holes106 located in the bottom of a “bowl”108 defined by theside aperture14. Theseholes106 are small enough to remove the fluids but not large enough to allow excised tissue portions to be removed through thefirst vacuum tube34, which is fluidly connected to thevacuum chamber tube102. A sharpened, metallicdistal end110 is attached to the distal end of theprobe12. It is designed to penetrate soft tissue such as the breast. In this embodiment, the sharpeneddistal end110 is a three-sided, pyramidal-shaped point, although the tip configuration may also have other shapes.
• Still referring toFIG. 2, the proximal end of theprobe12 is attached to aunion sleeve112 having alongitudinal bore114 through it, a widened center portion116, and atransverse opening118 through the widened center portion116. Theunion sleeve112 is mounted between the left andright handle shells92,94 on a pair ofunion sleeve ribs120 projecting from eachhandle shell92,94. An elongated, metallic,tubular cutter122 is axially aligned within thelongitudinal bore114 of theunion sleeve112 and thecutter lumen100 of theprobe12 so that thecutter122 may slide easily in both the distal and proximal directions. A pair of cutter guides124 are integrally molded into each of thehandle shells92,94 to slidably retain thecutter122 in an coaxially aligned position with the proximal end of thecutter tube98.Cutter122 has asample lumen126 through the entire length of thecutter122. The distal end of thecutter122 is sharpened to form acutter blade128 for cutting tissue held against thecutter blade128 as thecutter122 is rotated. The proximal end of thecutter122 is attached to the inside of a cutter gear bore130 of acutter gear132. Thecutter gear132 may be metallic or polymeric, and has a plurality ofcutter gear teeth134, each tooth having a typical spur gear tooth configuration as is well known in the art.
• Still inFIG. 2, thecutter gear132 is driven by anelongated drive gear136 having a plurality ofdrive gear teeth106 designed to mesh with thecutter gear teeth134. The function of thedrive gear136 is to rotate thecutter gear132 and thecutter122 as they translate in both longitudinal directions. Thedrive gear136 may be made from a metal such as stainless steel for durability and strength or from a nonferrous material for MRI compatibility. Adistal drive axle138 projects from the distal end of thedrive gear136 and mounts into an axle support rib140 molded on the inside of theleft handle shell92. Agear shaft142 projects from the proximal end of thedrive gear136 and is supported by a gear shaft support rib (not shown) also molded on the inside of theleft handle shell92. Aleft cross pin146 is attached to the proximal end of thegear shaft142 as a means for rotationally engaging thedrive gear136.
• Still referring toFIG. 2, acarriage148 is provided to hold thecutter gear132 and to carry thecutter gear132 as it is rotated in the distal and proximal directions. In the illustrative version, thecarriage148 is molded from a rigid polymer and is cylindrically shaped with a threadedbore150 through it and with acarriage foot152 extending from its side. Thefoot152 has arecess154 formed into it for rotatably holding thecutter gear132 in the proper orientation for thecutter gear teeth134 to mesh properly with thedrive gear teeth137. Thecarriage148 is attached via the threaded bore150 to anelongated screw156 which is parallel to thedrive gear136. Thescrew156 has a plurality of conventionallead screw threads158 and may be made from a stainless steel. The rotation of thescrew156 in one direction causes thecarriage148 to move distally, while the reverse rotation of thescrew156 causes thecarriage148 to move proximally. In turn, thecutter gear132 moves distally and proximally according to the direction of the screw rotation, and thecutter122 is advanced or retracted. In this version, thescrew156 is shown with a right hand thread so that clockwise rotation (looking from the proximal to distal direction) causes thecarriage148 to translate in the distal direction. It is also possible to use a left hand thread for thescrew156 as long as provisions are made to do so in thecontrol unit28. Adistal screw axle160 and aproximal screw shaft162 project from the distal and proximal ends, respectively, of thescrew156. Thedistal screw axle160 mounts rotatably in adistal screw support48 of theright handle shell94 while theproximal screw shaft162 mounts rotatably in aproximal screw support164, also in theright handle shell94. Aright cross pin166 is attached to the proximal end of thescrew shaft162 as a rotational engagement means.
• FIGS. 2-3 also show the first andsecond vacuum tubes34,36 referred to earlier. The distal end of thefirst vacuum tube34 is attached to a polymeric vacuum fitting168 that inserts tightly into thetransverse opening118 of theunion sleeve112. This allows the communication of fluids in thecutter lumen100 to thefluid collection system26. Thefirst vacuum tube34 is contained within thehollow handle housing70 in an open space above thescrew156 and drivegear136, and exits the distal end of thehollow handle housing70 through anopening170. Thesecond vacuum tube36 is fluidly attached to the proximal end of an elongated, metallic,tubular tissue remover172. Thesecond vacuum tube36 exits thehollow handle housing70 alongside thefirst vacuum tube34 out theopening170. A strainer174 is attached to the distal end of thetissue remover172 to prevent the passage of fragmented tissue portions through it and into thefluid collection system26. Thetissue remover172 inserts slideably into thetubular cutter122. During operation of the biopsy instrument, thetissue remover172 is always stationary and is mounted between a pair ofproximal supports176 on the inside of the left andright handle shells92,94. When thecutter122 is fully retracted to the first position, the distal end of thetissue remover172 is approximately even with the distal end of thecutter122. The distal end of thecutter122 when at its first, fully retracted position, is slightly distal to avertical wall178 which is proximal and perpendicular to thetissue sampling surface90.
• InFIG. 3, aright access hole180 is shown in the proximal end of the right handle shell43. Theright access hole180 provides access to the proximal end of thescrew156 for operational engagement to thepower transmission source30. Similarly, a left access hole (not shown) is provided in theleft handle shell92 to provide access to the proximal end of thedrive gear136 for operational engagement with thepower transmission source30.
• Thetissue remover172 has two functions. First, it helps to evacuate fluids contained in thecutter lumen100. This is accomplished by the attachment of thesecond vacuum tube36 to the proximal end of thetissue remover172. Since the distal end of thetissue remover172 is inserted into thecutter lumen100, thecutter lumen100 is fluidly connected to thefluid collection system26. Second, thetissue remover172 removes tissue from thecutter122 as follows. When a tissue sample is taken, thecutter122 advances to the fourth position just distal to theside aperture14, and asevered tissue portion184 is captured within thesample lumen126 in the distal end of thecutter122. Then thecutter122 translates to the first position so that thecutter blade128 is just distal ofvertical wall178. At this position of thecutter122, the distal end of the tissue remover172 (which is always stationary) is approximately even with the distal end of thecutter122. Therefore, any tissue portion of significant size contained within thesample lumen126 is pushed out of thesample lumen126 and onto thetissue sampling surface90. Thetissue portion184 may then be retrieved by the operator or an assistant.
• With particular reference toFIG. 3, an isometric view of thehandle20 with theleft handle shell92 removed reveals the placement of the components described forFIG. 3. Part of thefirst vacuum tube34 has also been removed for clarity. Thecarriage148 is shown in the fully retracted position so that thecutter122 is also at the fully retracted, or first position. Thecutter blade128 is slightly distal to thevertical wall178 on thehandle housing70. Thefoot152 of thecarriage148 is adapted to slide along acarriage guide surface186 on the inside bottom of thehollow handle housing70. A cutter axial transmission188 includes thecarriage148, thescrew156, and thescrew shaft162. A cutter rotational transmission190 includes thedrive gear136, thecutter gear132, and thegear shaft142.
• FIG. 4 is an exploded isometric view of thedetachable holster22. The holsterupper shell64 and a holsterlower shell76 are each injection molded from a rigid, biocompatible plastic such as polycarbonate. Upon final assembly, theshells64,76 are joined together by screws (not shown) or other types of fasteners well known in the art, into a plurality of alignment holes192. Agear drive shaft194 and ascrew drive shaft196 are contained within the proximal, enclosed portion of thedetachable holster22. These shafts extend from agrommet198 which has agroove200 for retainably mounting onto a shell edge202 of both holster upper andlower shells64,76, respectively. Thegrommet198 rotatably attaches the firstrotatable shaft50 to thegear drive shaft194 and the secondrotatable shaft52 to thescrew drive shaft196. The firstrotatable shaft50 rotatably inserts into aleft bore204 of thegrommet198. The secondrotatable shaft52 rotatably inserts into aright bore206. Thegrommet198 also provides a strain-relieved attachment of thecontrol cord54 to thedetachable holster22.
• Still referring toFIG. 4, thegear drive shaft194 is supported rotatably upon a pair of gear drive mounts208 formed into afirst wall210 and asecond wall212 of the inside of the upper andlower holster shells64,76. Thescrew drive shaft196 is likewise supported rotatably on screw drive mounts214. Aleft coupler216 is attached to the distal end of thedrive gear shaft194 and has aleft coupler mouth218 for rotational engagement with theleft cross pin146 attached to thegear shaft142. When thehandle20 shown inFIG. 2 is attached to thedetachable holster22, thegear shaft142 becomes rotatably engaged to thegear drive shaft194. Similarly, thescrew drive shaft196 has aright coupler220 with aright coupler mouth221 which rotatably engages with thecross pin166 of thescrew shaft162. Each of the left andright couplers216,220 have acoupler flange222,224 that rotatably insert intothrust slots226 formed into the corresponding portions of the drive mounts158,160. Thesecoupler flanges222,224 bear the axial loading of thedrive shafts180,182.
• With reference toFIGS. 4-4A, thedetachable holster22 further includes ascrew rotation sensor228, available from Hewlett-Packard as part number HEDR-81002P, for providing an electronic signal to thecontrol unit28 to be described in more detail later. Therotation sensor228 is mounted within the inside of the holsterupper shell64 and in a position directly above thescrew drive shaft196. Afluted wheel230 is attached to thescrew drive shaft196 and extends in front of a light emitting diode (not shown) contained within therotation sensor228. As thefluted wheel230 rotates, the interrupted light beams are electronically detected and transmitted back to thecontrol unit28 to provide information about the rotational speed of the screw drive shaft (cutter tube axial advancement or retraction speed), and the number of screw rotations from the beginning of operation (instantaneous axial position of the cutter122). Rotation sensor leads232 pass through thegrommet198 and are part of the bundle of conductors within thecontrol cord54.
• Thedetachable holster22 has theswitches78,80,82 mounted on the inside of the holsterupper shell64. Theswitches78,80,82 are electronically connected to a plurality ofconductors234 contained in thecontrol cord54. Thethird switch82 operates the fluid communication between thehandpiece32 and thefluid collection system26 and also sets thecontrol unit28 to respond to various commands; thesecond switch80 operates the movement of thecutter122 in the proximal direction and sets thecontrol unit28 to respond to various commands; and thefirst switch78 operates the movement of thecutter122 in the distal direction and sets thecontrol unit28 to respond to various commands. The functions of theswitches78,80,82 are not restricted to what has been described for the first embodiment. Also, the physical locations of theswitches78,80,82 on thehandpiece32 are not restricted to the locations depicted inFIG. 4.
• Use Of Sleeve To Adjust Side Aperture Of Long Stroke Biopsy Device:
• InFIGS. 5-6, theprobe sleeve16 is shown detached from thebiopsy system10 and advantageously is open along a lower longitudinal portion to allow for snapping onto theprobe14. In particular, aproximal collar302 has an interrupted figure-eight inner contour304 (FIG. 5) corresponding to a lateral cross section of theprobe12. Alower opening306 in theproximal collar302 flares outwardly into an actuator for manual positioning of theprobe sleeve16. In particular, afinger flange308 that has a wider arcing opening310 so that a right lower portion of theproximal collar302 extends unsupported as aflexible locking lip312. A distally projectinghalf tube314 is attached to theproximal collar302 and overarches a top portion of theprobe12 with inwardly directed left andright ridges316,318 running along each lateral lower edge of thehalf tube314 to longitudinally slidingly engage a pinched lateral waist320 of theprobe12. Thehalf tube314 distally terminates in a beveled edge322 (FIG. 6) to provide for smoother insertion at the insertion point into tissue, as illustrated inFIGS. 7A-7C wherein theprobe sleeve16 is first proximal to the side aperture14 (FIG. 7A), then slid over a proximal portion of theside aperture14 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 aperture14 (FIG. 7C).
• In use, inFIG. 8A, theprobe12 has been inserted throughskin340 until theside aperture14 has been placed adjacent to asuspicious lesion342. Vacuum pressure as indicated byarrows344 flows proximally throughsample lumen126, through thecutter tube122 and, as indicated byarrows346, throughvacuum holes108 in thebowl106 into thevacuum lumen104. The vacuum assistance causes a portion of thesuspicious lesion342 to prolapse into thebowl106 of theprobe12. InFIG. 8B, thecutter tube122 is being simultaneously rotated and distally translated to cut a biopsy sample. Vacuum continues to be drawn proximally throughsample lumen126 to assist in drawing in the severed tissue, as depicted byarrows348, with vacuum also continuing to be drawn from the vacuum holes108 in thebowl106 through thevacuum lumen104 to maintain the prolapsed tissue in thebowl106 for cutting. InFIG. 8C, thecutter tube122 has reached its most distal position. Thetissue sample184 is in the process of being transported out of the tissue by retracting thecutter tube122 proximally just distal ofvertical wall178 as shown inFIG. 3 until thetissue sample184 is ejected ontosampling surface90 via strainer174 as shown inFIG. 2.
• Transparent, Marked Probe Sleeve With Cutter Gouge Protection:
• InFIGS. 9-11, analternative probe sleeve350 includes atransparent body352 molded from an MRI compatible material. A halfcylindrical tube portion354 of thetransparent body352 distally terminates in an outer rampedsurface356 for atraumatic insertion into an opening into tissue formed by the biopsy device (not shown inFIGS. 9-11). The halfcylindrical tube portion354 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. Distal and proximalrelieved areas358,360 along a lower right edge of the halfcylindrical tube portion354 define there between a left curvedgripping flange362 that wraps slightly farther than a half circle contour of the distal portion of the halfcylindrical tube portion354 to resiliently lock onto the needle. A rectangularrelieved area364 along a distal lower right edge of the halfcylindrical tube portion354 defines with the proximally spaced right-side recess366, which is laterally across from the distal recess385 on the left side. A right gripping flange368 (shown in phantom) also wraps slightly under the right side of the needle for additional gripping.
• Alignment and gripping of the halfcylindrical tube portion354 is enhanced by overmolding atransparent thermoplastic portion370 onto an MRIcompatible spine portion372, which in the illustrative version is a flat non-ferromagnetic metal (e.g., titanium) that is stamped and formed into atop spine374, pairs of radiatingribs376 for additional strength and grip and a distal half-cylinder guide378 that underlies the outer rampedsurface356 and has sufficient longitudinal length to overlay a side aperture. The distal half-cylinder guide378 serves as protection against gouging of the softer transparentthermoplastic portion370 by the cutter tube. Thereby, introduction of debris into the side aperture is avoided. The pairs ofribs376 and/or molded or applied measurement marks380 into thethermoplastic portion370 give a visual indication external to the patient as to how far the outer rampedsurface356 has been inserted along the shaft of the needle into tissue. The user performs this adjustment by grasping a halfcircular disk flange382 attached along distal edges of a pair of left and right flankinghorizontal tabs384,386, each extending transverse to the proximal end of the halfcylindrical tube portion354. InFIG. 12, an alternative MRIcompatible reinforcement portion390 omits pairs of ribs for some applications.
• InFIG. 13, an additionalalternative probe sleeve400 is similar if not identical to that depicted inFIG. 10 with several exceptions. First, 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 halfcylindrical tube portion402 and the left and righthorizontal tabs384,386 are omitted aft of the left curvedgripping flange362. A heightened halfoval flange404 replaces the half circular flange and is paired with a distally spaced second heightened halfoval flange406 for positioning theprobe sleeve400. Bothflanges404,406 are transverse to the halfcylindrical tube portion402 and longitudinally flank the left curvedgripping flange362.
• InFIG. 14, a furtheralternative probe sleeve420 formed of a transparent MRI compatible material includes a halfcylindrical tube portion422 with a distal outer rampedportion424. Markingindicia426 are molded along lateral sides of the halfcylindrical tube portion422. Left andright recesses428,430 and aproximal edge432 define there between respective left and right curvedgripping flanges434,436 that wrap further around the needle to grip. Longitudinal positioning as well as releasing the left and right curvedgripping flanges434,436 is facilitated by left and right clip levers438,440 that flare upwardly and outwardly respectively from the grippingflanges434,436. Depressing the clip levers438,440 toward each other pries the respectivegripping flanges434,436 outwardly out of engagement with a needle (not shown).
• InFIGS. 15-16, yet a furtheralternative probe sleeve450 is similar if not identical to that depicted inFIG. 10 with a reinforcement portion omitted. To avoid gouging of the MRI compatible transparent material by the cutter tube, the inner and outer contours of adistal portion452 of a halfcylindrical tube portion454 are heightened to avoid contact.
• Short Stroke Biopsy Device With Variable Aperture Implementation:
• In the second illustrative version depicted inFIG. 17, a short stroke coresampling biopsy system510 includes ahandpiece530 that may be held comfortably in a single hand, and may be manipulated with a single hand.Handpiece530 may include aprobe assembly532 and a detachablyconnected holster534.Probe assembly532 may be operatively connected to avacuum source536, such as by a first,lateral tube538 and a second,axial tube540. First andsecond tubes538,540 may be made from a flexible, transparent or translucent material, such as silicon tubing, PVC tubing or polyethylene tubing. Using a transparent material enables visualization of the matter flowing throughtubes538,540.
• First tube538 may includes aY connector542 for connecting to multiple fluid sources. A first proximal end ofY connector542 may extend to a first solenoid controlledrotary valve544 in acontrol module546, while the second proximal end of theY connector542 may extend to a second solenoid controlledrotary valve548 incontrol module546. The first solenoid controlledrotary valve544 incontrol module546 may be operable to connect either thevacuum source536 or acompressed air source550 tolateral tube538. It is understood within this specification that compressed air means air pressure at or above atmospheric pressure. In one configuration, whenvalve544 is activated, vacuum is supplied totube538 fromvacuum source536, and whenvalve544 is not activated, pressurized air fromcompressed air source550 is supplied throughtube538. The solenoid associated withvalve544 may be controlled by amicroprocessor552 incontrol module546, as indicated by dashedline554. Themicroprocessor552 may be employed to adjust the position ofvalve544 automatically based upon the position of a cutter555 (as shown inFIG. 20) movably supported withinprobe assembly532. The second solenoid controlledrotary valve548 incontrol module546 may be employed to either connect a saline supply556 (such as a saline supply bag, or alternatively, a pressurized reservoir of saline) to atube558 or to seal off the proximal end oftube558. For instance,rotary valve548 may be activated bymicroprocessor552 to supply saline when one ofswitches560 onhandpiece530 is actuated. Whenrotary valve548 is activated, firstrotary valve544 may be automatically deactivated (such as by microprocessor552) to prevent the interaction of vacuum and saline withinlateral tube538. Astopcock561 may be included inlateral vacuum tube538 to allow for a syringe injection of saline directly into thetube538, if desired. For instance, 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.
• In one version,axial vacuum tube540 may be employed to communicate vacuum fromsource536 to probe assembly532 through atissue storage assembly562.Axial tube540 may provide vacuum through thecutter555 withinprobe assembly532 to assist in prolapsing tissue into aside aperture564 prior to cutting. After cutting occurs, the vacuum inaxial tube540 may be employed to help draw a severed tissue sample fromprobe assembly532 and intotissue storage assembly562, as will be described in further detail below.
• Holster534 may include acontrol cord566 for operationally connectinghandpiece530 to controlmodule546, and a flexiblerotatable shaft568 connecting theholster534 to adrive motor570. Apower source572 may be employed to provide energy to controlmodule546 for poweringholster534 viacontrol cord566.Switches560 are mounted on holsterupper shell574 to enable an operator to usehandpiece530 with a single hand. One-handed operation allows the operator's other hand to be free, for example, to hold an ultrasonic imaging device.Switches560 may include a two-position rocker switch576 for manually actuating the motion of the cutter555 (e.g. forward movement of the rocker switch moves thecutter555 in the forward (distal) direction for tissue sampling and rearward movement of the rocker switch576 actuates thecutter555 in the reverse (proximal) direction. Alternatively, thecutter555 could be automatically actuated bycontrol module546. Anadditional switch578 may be provided onholster534 for permitting the operator to activate saline flow on demand into lateral tube538 (for instance, switch578 may be configured to operatevalve548 for providing saline flow totube538 whenswitch578 is depressed by the user).
• FIG. 18shows probe assembly532 disconnected fromholster534.Probe assembly532 includes anupper shell580 and alower shell582, each of which may be injection molded from a rigid, biocompatible plastic, such as a polycarbonate. Upon final assembly ofprobe assembly532, upper andlower shells580,582 may be joined together along a joiningedge584 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.
• FIGS. 19A, 19B,19C, and20 illustrateprobe assembly532 in greater detail.FIG. 19A depicts a cutter assembly andcarriage586 retracted proximally.FIG. 19B depicts the cutter assembly andcarriage586 partially advanced.FIG. 19C depicts the cutter assembly andcarriage586 advanced distally. With particular reference toFIG. 20, theprobe assembly532 may include a biopsy needle (probe)588 located at a distal end of ahandle589 of theprobe assembly532 for insertion into a patient's skin to obtain a tissue sample.Needle588 comprises an elongated,metallic cannula590, which may include anupper cutter lumen592 for receiving thecutter555 and alower vacuum lumen594 for providing a fluid and pneumatic passageway.Cutter555 may be disposed withincannula590, and may be coaxially disposed withincutter lumen592.
• Cannula590 may have any suitable cross-sectional shape, including a circular or oval shaped cross-section. Adjacent and proximal of the distal end ofcannula590 is theside aperture564 for receiving the tissue to be severed from the patient. The sharpened tip ofneedle588 may be formed by aseparate endpiece596 attached to the distal end ofcannula590. The sharpened tip ofendpiece596 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.piece596 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 ofneedle588 may be attached to aunion sleeve598 having alongitudinal bore600 therethrough, and atransverse opening602 into a widened center portion of thebore600. The distal end oflateral tube538 may be inserted to fit tightly intotransverse opening602 ofunion sleeve598. This attachment allows the communication of fluids (gas or liquid) between thelower vacuum lumen594 and thelateral tube538.
• Thecutter555, which may be an elongated, tubular cutter, may be disposed at least partially withinupper cutter lumen592, and may be supported for translation and rotation withincutter lumen592.Cutter555 may be supported withinvacuum lumen594 so as to be translatable in both the distal and proximal directions.Cutter555 may have a sharpeneddistal end606 for cutting tissue received inupper cutter lumen592 throughside aperture564. Thecutter555 may be formed of any suitable material, including without limitation a metal, a polymer, a ceramic, or a combination of materials.Cutter555 may be translated withincutter lumen592 by a suitablecutter drive assembly607 such thatdistal end606 travels from a position proximal of the side aperture564 (illustrated inFIG. 19A) to a position distal of side aperture564 (illustrated inFIG. 19C), in order to cut tissue received incutter lumen592 through theside aperture564. In an alternative embodiment, 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 sleeve598 is supported between probe upper andlower shells580,582 to ensure proper alignment betweencutter555 and theunion sleeve598. Thecutter555 may be a hollow tube, with asample lumen608 extending axially through the length ofcutter555. The proximal end ofcutter555 may extend through an axial bore of acutter gear610.Cutter gear610 may be metallic or polymeric, and includes a plurality ofcutter gear teeth612.Cutter gear610 may be driven by arotary drive shaft614 having a plurality ofdrive gear teeth616 designed to mesh withcutter gear teeth612.Drive gear teeth616 may extend along the length ofdrive shaft614 so as to engagecutter gear teeth612 as thecutter555 translates from a proximal most position to a distal most position, as illustrated inFIGS. 19A-19C.Drive gear teeth616 may be in continual engagement withcutter gear teeth612 to rotatecutter555 wheneverdrive shaft614 is rotatably driven. Driveshaft614 rotatescutter555 as the cutter advances distally throughside aperture564 for the cutting of tissue. Driveshaft614 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. Driveshaft614 includes a firstaxial end620 extending distally from theshaft614.Axial end612 is supported for rotation within probelower shell582, such as by a bearingsurface feature622 molded on the inside of theprobe shells580,582. Similarly, a secondaxial end624 extends proximally fromrotary drive shaft614 and is supported in a secondbearing surface feature626, which may also be molded on the inside of probelower shell582. An0-ring and bushing (not shown) may be provided on eachaxial end620,624 to provide rotational support and audible noise dampening of theshaft614 whenrotary drive shaft614 is mounted in probelower shell582.
• As shown inFIGS. 19A, 19B,19C, and20, adrive carriage634 is provided inprobe assembly532 to holdcutter gear610, and carry the cutter gear and attachedcutter555 during translation in both the distal and proximal directions. Drivecarriage634 may be molded from a rigid polymer and has a cylindrically-shapedbore636 extending axially therethrough. A pair of J-shapedhook extensions640 extend from one side ofdrive carriage634.Hook extensions640rotatably support cutter555 on either side ofcutter gear610 to provide proximal and distal translation of thecutter gear610 andcutter555 during proximal and distal translation ofdrive carriage634.Hook extensions640align cutter555 andcutter gear610 in the proper orientation forcutter gear teeth612 to mesh withdrive gear teeth616.
• Drivecarriage634 is supported on atranslation shaft642.Shaft642 is supported generally parallel tocutter555 androtary drive shaft614. Rotation of thetranslation shaft642 provides translation of the drive carriage634 (and so alsocutter gear610 and cutter555) by employing a lead screw type drive.Shaft642 includes an external lead screw thread feature, such aslead screw thread644, on its outer surface. Thescrew thread644 extends into thebore636 indrive carriage634. Thescrew thread644 engages an internal helical threaded surface feature(not shown) provided on the inner surface ofbore636. Accordingly, asshaft642 is rotated, thedrive carriage634 translates along the threadedfeature644 of theshaft642. Thecutter gear610 and thecutter555 translate with thedrive carriage634. Reversing the direction of rotation ofshaft642 reverses the direction of translation of thedrive carriage634 and thecutter555.Translation shaft642 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.Translation shaft642 with leadscrew thread feature644 may be molded, machined, or otherwise formed. Likewise, drivecarriage634 may be molded or machined to include an internal helical thread inbore636. Rotation ofshaft642 drives the carriage andcutter gear610 andcutter555 in distal and proximal directions, depending upon the direction of rotation ofshaft642, so thatcutter555 translates withinprobe assembly532.Cutter gear610 is rigidly attached tocutter555 so that the cutter translates in the same direction and at the same speed asdrive carriage634.
• In one version, at the distal and proximal ends oflead screw thread644, the helical thread is cut short so that the effective pitch width of the thread is zero. At the distal most and proximal most positions ofthread644, translation ofdrive carriage634 is no longer positively driven byshaft642 regardless of the continued rotation ofshaft642, as the carriage effectively runs offthread644. Biasing members, such ascompression coil springs650a and650b (FIG. 20), are positioned onshaft642 adjacent the distal and proximal ends ofscrew thread644.Springs650a/bbias drive carriage634 back into engagement withlead screw thread644 when the carriage runs offthread644. Whileshaft642 continues rotating in the same direction, the zero pitch width thread in combination withsprings650a\fbcause drive carriage634 and, therefore,cutter555 to “freewheel” at the end of the shaft. At the proximal end of the threaded portion ofshaft642,drive carriage634 engagesspring650a. At the distal end of the threaded portion ofshaft642,drive carriage634 engagesspring650b. Whendrive carriage634 runs offscrew thread644,spring650aor650bengagesdrive carriage634 and biases drivecarriage634 back into engagement withscrew thread644 ofshaft642, at which point continued rotation ofshaft642 again causes drivecarriage634 to run offscrew thread644. Accordingly, as long as rotation ofshaft642 is maintained in the same direction, drive carriage634 (and cutter555) will continue to “freewheel”, with the distal end ofcutter555 translating a short distance proximally and distally as the carriage is alternately biased ontothread644 byspring650aor650band then run offscrew thread644 by rotation ofshaft642. When the cutter is in the distal most position shown inFIG. 19C, with thedistal end606 ofcutter555 positioned distal ofside aperture564, spring650bwill engagedrive carriage634, and repeatedly urgedrive carriage634 back into engagement withscrew thread644 whendrive carriage634 runs offscrew thread644. Accordingly, aftercutter555 is advanced such that thedistal end606 ofcutter555 translates distallypast side aperture564 to cut tissue, to the position shown inFIG. 19C, continued rotation ofshaft642 will result indistal end606 oscillating back and forth, translating a short distance proximally and distally, until the direction of rotation ofshaft642 is reversed (such as to retractcutter555 distally to the position shown inFIG. 19A). The slight movement ofdrive carriage634 into engagement withscrew thread644 and out of engagement withscrew thread644 against the biasing force ofspring650b, causes thedistal end606 ofcutter555 to repetitively reciprocate a short distance withincannula590, which distance may be about equal to the pitch ofthreads644, and which distance is shorter than the distance the cutter travels in crossingside aperture564. This reciprocal movement ofcutter555 may provide alternate covering and uncovering of at least one fluid passageway disposed distally ofside aperture564, as described below.
• The zero pitch width ends oflead screw thread644 provide a defined stop for the axial translation ofcutter555, thereby eliminating the need to slow drive carriage634 (i.e. cutter555) as it approaches the distal and proximal ends of the thread. This defined stop reduces the required positioning accuracy fordrive carriage634 relative toshaft642, resulting in reduced calibration time at the initialization of a procedure. The freewheeling ofdrive carriage634 at the distal and proximal most positions oftranslation shaft642 eliminates the need to rotate shaft642 a precise number of turns during a procedure. Rather,translation shaft642 only needs to translate at least a minimum number of turns to insuredrive carriage634 has translated the entire length oflead screw thread644 and into the zero width thread. Additionally, the freewheeling ofdrive carriage634 eliminates the need to home the device, allowingprobe assembly532 to be inserted into the patient's tissue without first being attached toholster534. Afterprobe assembly532 is inserted,holster534 is attached and sampling may be commenced.
• As shown inFIG. 20, a non-rotatingrear tube652 may be provided in whichtube652 may extend proximally from the proximal end ofcutter555 just proximal ofcutter gear610.Rear tube652 may be hollow, may have substantially the same inner diameter ascutter555, and may be comprised of the same material ascutter555. Aseal654 may be positioned betweencutter555 andrear tube652 to enablecutter555 to rotate relative torear tube652 while providing a pneumatic seal betweenrear tube652 andcutter555. Arear lumen656 may extend through the length oftube652 and may be aligned withsample lumen608 incutter555.Rear lumen656 transports excised tissue samples fromsample lumen608 throughprobe assembly532 totissue storage assembly562.Sample lumen608 andrear lumen656 are axially aligned to provide a continuous, generally straight lined, unobstructed passageway betweenside aperture564 andtissue storage assembly562 for the transport of tissue samples. The inner surfaces ofcutter555 andtube652 may be coated with a hydrolubricous material to aid in the proximal transport of the excised tissue samples.
• Alateral extension658 may be provided and may be supported by and extend distally fromrear tube652 for securing thetube652 to drivecarriage634. Theextension658 connectstube652 to drivecarriage634 so thattube652 translates withcutter555, and maintainslumens608,656 in continuous fluid-tight communication throughout the cutting cycle.
• FIGS. 21A - 21C provide simplified schematic views of the movement ofcutter555 during a cutting cycle of thebiopsy system510. As shown inFIG. 21A,cutter555 is located at a distal-most position withdistal cutting end606 disposed distally of the distal most edge of theside aperture564. This position is similar to when theprobe assembly532 is being prepared for insertion.
• With theprobe assembly532 thus positioned, thecutter555 is retracted a preprogrammed amount, as shown inFIG. 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 anexternal surface672 ofbody tissue673 encompasses a proximal blockedportion674 of theside aperture564 with a distal unblockedportion675 of the side aperture adjacent to asuspicious lesion676. As the cutting cycle begins as depicted, a lateral vacuum force (indicated by arrow677) may be provided inlower vacuum lumen594.Vacuum force677 may be transmitted fromvacuum source536 throughtube538 tolower vacuum lumen594 through a flow path provided by union sleeve598 (not shown inFIG. 21B). Thisvacuum force677 maintains a portion of thesuspicious lesion676 in a prolapsed position inside of thebowl671 for cutting.Microprocessor552 may be employed to activatevalve544 to supplyvacuum force682 when switch576 is actuated by the user to begin movingcutter555 distally withinneedle588.Lateral vacuum force682 communicates withside aperture564 throughfluid passageways678 disposed underside aperture564, and through one or morefluid passageways679 disposed distally of theside aperture564.
• Lateral vacuum force677 may be employed in combination with anaxial vacuum force680 throughsample lumen608 to draw atissue sample682 intoside aperture564. Aftertissue sample682 is drawn intoside aperture564,cutter555 may be rotated and simultaneously translated distally to sever thetissue sample682 from the surrounding tissue. Whilecutter555 advances,vacuum forces677,680 may be maintained throughlower vacuum lumen594 andsample lumen608 to draw thetissue sample682 into thesample lumen608 as thesample682 is severed. As shown inFIG. 21B, ascutter555 advances thecutter555 slides acrossfluid passageways678, successively blocking thelateral vacuum677 throughfluid passageways678.
• Whencutter555 reaches the distal most position, as shown inFIG. 21C,fluid passageways678 may be completely blocked bycutter555. Withpassageway679 open,lower vacuum lumen594 remains in fluid communication withsample lumen608 throughdivider670 despite the blocking ofpassageways678.
• A predefined amount of time aftercutter555 reaches its distal most position and begins to freewheel, the solenoid onrotary valve544 may be deenergized or otherwise controlled bymicroprocessor552 to replacelateral vacuum force677 with forward pressurized air (either atmospheric or greater) as shown by thearrows682 inFIG. 21 C. The pressurized air is discharged throughlateral tube538 tovacuum lumen594. With port holes678 closed off bycutter555, the pressurized air communicates withupper cutter lumen592 throughfluid passageway679 to apply a force against the distal face ofsample682. The “push” force acting on the distal face ofsample682 may act in combination with “pull”axial vacuum force680 provided throughsample lumen608 ofcutter555 to movesample682 into and throughsample lumen608 ofcutter555, as shown inFIG. 21 C. Alternatively, instead of employing pressurized air to provide a force on the distal face ofsample682, a pressurized liquid, such as saline, may be directed throughlower vacuum lumen594 andfluid passageways679 to provide the force on the distal face ofsample682. Thecutter555 closesside aperture564 from the flow of fluid (gas or liquid) so that tissue surrounding the outer cannula andside aperture564 is not exposed to the fluid.
• As thetissue sample682 translates proximally throughprobe assembly532 towardssample collection assembly562,cutter555 may be maintained in a distal most position. Alternatively,cutter555 may be retracted back throughside aperture564 towards its initial position in preparation for the next cutting cycle. Aftercutter555 is retracted to its partially blocking position, and the tissue sample is translated totissue storage assembly562,lateral vacuum force677 is again provided viavacuum lumen594 to draw the next tissue sample intoside aperture564. During the translation ofcutter555,cutter555 may operate in conjunction withdivider670 toseparate cutter lumen592 fromvacuum lumen594.
• During the cutting cycle,cutter555 translates from a point selectively either just proximal of side tissue receivingside aperture564 or in the partially blocking position to a point just distal ofside aperture564. The severedtissue samples682 are directed through the length ofsample lumen608 ofcutter555 and out of the proximal end ofcutter555, rather than translating with cutter555 (with the samples carried in the distal end of the cutter) proximally throughneedle588 to ejectsamples682 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 theside aperture564. With the reduced stroke25. length, the distal end of cutter555 (as well as a length of cutter555) may remain withinneedle588 throughout the cutting cycle, eliminating the need to accommodate the full length ofcutter555 within probe housing (handle)589 and proximal ofneedle588. In addition, the reduced cutting stroke length reduces the required length oftranslation shaft642, since the shaft need only translate cutter555 a distance slightly longer than the length ofside aperture564. Reducing the translation shaft length, and eliminating the need to accommodate the cutter length within the probe housing (handle)589, enables the length ofhandpiece530 to be reduced. The time required to acquire each tissue sample is also reduced in the present invention, due to the shortened cutting stroke reducing the time required to advance and retract the cutter throughcannula590.
• It should be appreciated that thebiopsy system510 advantageously supports an effectively reduced side aperture mode when desired. The reduced proximal travel ofcutter555 allowsbiopsy system510 to be used on patients where the breast is compressed to a thin cross-section. Under these circumstances,biopsy needle588 is inserted into the breast and the proximal end ofside aperture564 is not within the breast. The reduced cutter translation length effectively reduces the length ofside aperture564 preventing the sharpdistal edge606 ofcutter555 from contacting the patient's skin during each sampling cycle. The reduced cutter translation length may be preprogrammed into themicroprocessor552 located incontrol module546 by the user before or during the procedure.
• SHORTENED DISTAL PIERCING TIP: InFIG. 22, aprobe712 for theprobe assemblies18,532 advantageously includes a piercingtip720 having a reduced longitudinal length (e.g., approximately2 mm shorter) than generally-known piercing tips so as to reduce the “dead space” to adistal end722 of aside aperture724 in acutter lumen726. Generally known dead spaces are often about8 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 piercingtip720 may be a flat blade as depicted or a pyramidal tip, a rounded cone with needle point, orthogonally crossing flat blades or other shapes.
• As an alternative approach and apparatus, 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. Once the piercing tip reaches the surgical site, 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.
• While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the spirit and scope of the appended claims. Additionally, each element described in relation to the invention may be alternatively described as a means for performing that element's function.
• For example, 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. For instance, 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.
• As another example, a sleeve may include a longitudinally stepped recess such that rotation presents either a blocking position or a nonblocking position, which may be particularly applicable to circular probes. A proximally placed turn wheel on such a sleeve may provide a visual indication of the current position and the direction of rotation to change the condition.
• As another example, a frangibly-attached blocking member may be formed across the proximal portion of the side aperture. When a full-sized sample is planned, this block member may be detached and disposed of.
• As yet another example, a similar probe sleeve may be advantageously used with a biopsy system that does not rely upon vacuum assist (e.g., palpitating tissue into the bowl of the probe during ultrasonic imaging).

Claims (26)

1. A device for selectively blocking a proximal portion of a side aperture in a needle or a core biopsy instrument having a cutter that translates across the side aperture to sever prolapsed tissue, comprising:

a half cylindrical tube portion having an inner contour corresponding to the side aperture and a proximate upper portion of the needle of the core biopsy instrument;

a gripping flange attached to the half cylindrical tube portion positioned to resiliently lock to an underside of a proximate lower portion of the needle; and

a finger flange attached to a proximal portion of the half cylindrical tube portion sized for manual longitudinal positioning of the half cylindrical tube portion relative to the side aperture.

2. The device ofclaim 1, wherein the half cylindrical tube portion comprises a transparent material.

3. The device ofclaim 1, wherein the half-cylindrical tube portion comprises a magnetic resonance imaging compatible material.

4. The device ofclaim 1, wherein the half cylindrical tube portion further comprises a distal outer ramped surface.

5. The device ofclaim 1, wherein a distal portion of the half cylindrical tube portion comprises an inner relieved contour sized to avoid contact with the cutter of the core biopsy instrument.

6. The device ofclaim 1, wherein a distal portion of the half cylindrical tube portion comprises an inner metallic guide resistant to damage from the cutter of the core biopsy instrument.

7. The device ofclaim 1, wherein the half cylindrical tube portion further comprises measurement indicia.

8. The device ofclaim 1, further comprising a metallic reinforcement portion attached to the half cylindrical tube portion.

9. The device ofclaim 1, wherein the gripping flange comprises left and right gripping flanges, each gripping flange attached to upwardly and outwardly diverging finger flanges manually depressed together to flare the gripping flanges out of engagement with the needle of the core biopsy instrument.

10. A device for selectively blocking a proximal portion of a side aperture in a needle or a core biopsy instrument having a cutter that translates across the side aperture to sever prolapsed tissue, comprising:

a transparent half cylindrical tube portion having an inner contour corresponding to the side aperture and a proximate upper portion of the needle of the core biopsy instrument, the inner contour including a distal portion operatively configured to avoid damage from the cutter of the core biopsy instrument;

a gripping flange attached to the half cylindrical tube portion positioned to resiliently lock to an underside of a proximate lower portion of the needle; and

a finger flange attached to a proximal portion of the half cylindrical tube portion sized for manual longitudinal positioning of the half cylindrical tube portion relative to the side aperture.

11. The device ofclaim 10, wherein the distal portion of the half cylindrical tube portion comprises an inner relieved contour sized to avoid contact with the cutter of the core biopsy instrument.

12. The device ofclaim 10, wherein the distal portion of the half cylindrical tube portion comprises an inner metallic guide resistant to damage from the cutter of the core biopsy instrument.

13. A biopsy device, comprising:

a piercing tube having a side aperture proximate to a distal end thereof defining a bowl portion within the piercing tube for receiving prolapsed tissue through the side aperture;

a cutter tube longitudinally translatable within the piercing tube;

a cutter drive assembly operatively configured to distally translate the cutter tube across the side aperture severing prolapsed tissue; and

a probe sleeve selectably positionable across a proximal portion of the side aperture.

14. The biopsy device ofclaim 13, wherein the probe sleeve comprises a collar selectively detachable from the probe tube.

15. The biopsy device ofclaim 14, further comprising:

a vacuum assistance system; and

a vacuum lumen attached along a length of the piercing tube in fluid communication with the bowl portion thereof forming a vacuum assisted probe and the vacuum assistance system;

wherein the probe sleeve further comprises a circumferential portion shaped to engage the piercing tube and vacuum lumen.

16. The biopsy device ofclaim 2, wherein the probe sleeve includes a proximally attached actuator shaped to be grasped by a user.

17. The biopsy device ofclaim 13, wherein the cutter lumen includes a piercing tip wherein a dead space longitudinal distance from a distal end of the side aperture to a distal-most end of the piercing tip is less than7.8 mm.

18. The biopsy device ofclaim 17, wherein the dead space longitudinal distance is approximately6 mm.

19. The device ofclaim 13, wherein the half cylindrical tube portion comprises a transparent material.

20. The device ofclaim 13 wherein the half-cylindrical tube portion comprises a magnetic resonance imaging compatible material.

21. The device ofclaim 13, wherein the half cylindrical tube portion further comprises a distal outer ramped surface.

22. The device ofclaim 13, wherein a distal portion of the half cylindrical tube portion comprises an inner relieved contour sized to avoid contact with the cutter of the core biopsy instrument.

23. The device ofclaim 13, wherein a distal portion of the half cylindrical tube portion comprises an inner metallic guide resistant to damage from the cutter of the core biopsy instrument.

24. The device ofclaim 13, wherein the half cylindrical tube portion further comprises measurement indicia.

25. The device ofclaim 13, further comprising a metallic reinforcement portion attached to the half cylindrical tube portion.

26. The device ofclaim 13, wherein the gripping flange comprises left and right gripping flanges, each gripping flange attached to upwardly and outwardly diverging finger flanges manually depressed together to flare the gripping flanges out of engagement with the needle of the core biopsy instrument.

Images