Abstract:
A biopsy device includes an elongate needle, a proximal portion, a cutter, and a vacuum conduit. The elongate needle defines an internal passage and includes a distal end and a first plurality of openings along an exterior surface of the elongate needle in communication with the internal passage. The first plurality of openings are sized to admit fluid and to resist the prolapse of tissue. The proximal portion is attached to the elongate needle and is positionable to insert the elongate needle into tissue. The cutter is reciprocally received by the elongate needle to sever a tissue sample received in the elongate needle. The cutter includes a cutter tube with a second plurality of openings in communication with the internal passage of the elongate needle. The vacuum conduit is attached to the proximal portion in communication with the internal passage and is coupled to a vacuum source.

Description:
PRIORITY 
     The present application is a continuation of U.S. patent application Ser. No. 13/025,366, entitled “Biopsy Device with Vacuum Assisted Bleeding Control,” filed Feb. 11, 2011, which is a continuation of U.S. patent application Ser. No. 11/424,576, entitled “Biopsy Device with Vacuum Assisted Bleeding Control,” filed Jun. 16, 2006, now U.S. Pat. No. 7,918,804, which is a continuation-in-part of U.S. patent application Ser. No. 11/198,558, entitled “Biopsy Device with Replaceable Probe and Incorporating Vibration Insertion Assist and Static Vacuum Source Sample Stacking Retrieval,” filed Aug. 5, 2005, now U.S. Pat. No. 7,867,173, the disclosures of which are 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, and even more particularly to biopsy devices for multiple sampling with a probe remaining inserted. 
     BACKGROUND OF THE INVENTION 
     When a suspicious tissue mass is discovered in a patient&#39;s breast through examination, ultrasound, MRI, X-ray imaging or the like, it is often necessary to perform a biopsy procedure to remove one or more samples of that tissue in order to determine whether the mass contains cancerous cells. A biopsy may be performed using an open or percutaneous method. 
     An open biopsy is performed by making a large incision in the breast and removing either the entire mass, called an excisional biopsy, or a substantial portion of it, known as an incisional biopsy. An open biopsy is a surgical procedure that is usually done as an outpatient procedure in a hospital or a surgical center, involving both high cost and a high level of trauma to the patient. Open biopsy carries a relatively higher risk of infection and bleeding than does percutaneous biopsy, and the disfigurement that sometimes results from an open biopsy may make it difficult to read future mammograms. Further, the aesthetic considerations of the patient make open biopsy even less appealing due to the risk of disfigurement. Given that a high percentage of biopsies show that the suspicious tissue mass is not cancerous, the downsides of the open biopsy procedure render this method inappropriate in many cases. 
     Percutaneous biopsy, to the contrary, is much less invasive than open biopsy. Percutaneous biopsy may be performed using fine needle aspiration (FNA) or core needle biopsy. In FNA, a very thin needle is used to withdraw fluid and cells from the suspicious tissue mass. This method has an advantage in that it is very low-pain, so low-pain that local anesthetic is not always used because the application of it may be more painful than the FNA itself. However, a shortcoming of FNA is that only a small number of cells are obtained through the procedure, rendering it relatively less useful in analyzing the suspicious tissue and making an assessment of the progression of the cancer less simple if the sample is found to be malignant. 
     During a core needle biopsy, a small tissue sample is removed allowing for a pathological assessment of the tissue, including an assessment of the progression of any cancerous cells that are found. The following patent documents disclose various core biopsy devices and are incorporated herein by reference in their entirety: U.S. Pat. No. 6,273,862 issued Aug. 14, 2001; U.S. Pat. No. 6,231,522 issued May 15, 2001; U.S. Pat. No. 6,228,055 issued May 8, 2001; U.S. Pat. No. 6,120,462 issued Sep. 19, 2000; U.S. Pat. No. 6,086,544 issued Jul. 11, 2000; U.S. Pat. No. 6,077,230 issued Jun. 20, 2000; U.S. Pat. No. 6,017,316 issued Jan. 25, 2000; U.S. Pat. No. 6,007,497 issued Dec. 28, 1999; U.S. Pat. No. 5,980,469 issued Nov. 9, 1999; U.S. Pat. No. 5,964,716 issued Oct. 12, 1999; U.S. Pat. No. 5,928,164 issued Jul. 27, 1999; U.S. Pat. No. 5,775,333 issued Jul. 7, 1998; U.S. Pat. No. 5,769,086 issued Jun. 23, 1998; U.S. Pat. No. 5,649,547 issued Jul. 22, 1997; U.S. Pat. No. 5,526,822 issued Jun. 18, 1996; and US Patent Application 2003/0199753 published Oct. 23, 2003 to Hibner et al. 
     At present, a biopsy instrument marketed under the trade name MAMMOTOME is commercially available from ETHICON ENDO-SURGERY, INC. for use in obtaining breast biopsy samples. These devices generally retrieve multiple core biopsy samples from one insertion into breast tissue with vacuum assistance. In particular, a cutter tube is extended into a probe to cut tissue prolapsed into a side aperture under vacuum assistance and then the cutter tube is fully retracted between cuts to extract the sample. 
     With a long probe, the rate of sample taking is limited not only by the time required to rotate or reposition the probe but also by the time needed to translate the cutter. As an alternative to this “long stroke” biopsy device, a “short stroke” biopsy device is described in the following commonly assigned 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. The cutter is cycled across the side aperture, reducing the sample time. Several alternative specimen collection mechanisms are described that draw samples through the cutter tube, all of which allow for taking multiple samples without removing the probe from the breast. 
     The vacuum assistance presented at the side aperture provides a further benefit of reducing the accumulation of bodily fluids around the probe that may tend to interfere with taking a diagnostic image, may impede subsequent insufflation and marker deployment, leave an undesirable hematoma at the biopsy site, and/or result in external bleeding that is a biohazard and may increase the patient&#39;s discomfort. 
     While these multiple sample core biopsy instruments have numerous advantages, it is believed that the diagnostic and therapeutic opportunities of core biopsy procedures would be more widely used if bleeding associated with a larger core biopsy probe were controlled and/or reduced. 
     SUMMARY OF THE INVENTION 
     The present invention addresses these and other problems of the prior art by providing a biopsy device and method that has a probe that is inserted into tissue to obtain a core biopsy sample by translating a cutter with the probe. Bleeding and fluid management is facilitated by a plurality of external holes in the probe that communicate through the probe tube to a vacuum supply. Thereby hematomas or external bleeding from around the probe, that would otherwise degrade diagnostic imaging or present other complications, is mitigated. 
     In one aspect of the invention, a biopsy device hand piece has a motorized translation and rotation drive mechanism that engages and operates a disposable probe assembly that includes the probe tube with the plurality of external holes. A cutter tube acts as the cutter translating with the probe tube, severing tissue that is prolapsed into the probe tube also under the urging from the vacuum supply. 
     In another aspect of the invention, a hemostatic ring pad is engageable to the probe tube to contact the skin during the biopsy procedure around an insertion point to reduce external bleeding. 
     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 an isometric, inverted view of a biopsy device including a disposable probe assembly incorporating bleeding fluid management and including a detached reusable hand piece with a housing depicted in phantom and diagrammatically attached to a vacuum canister and vacuum supply. 
         FIG. 2  is an isometric view of the biopsy device of  FIG. 1 . 
         FIG. 3  is an isometric right-side detail view of a distal portion of the biopsy device of  FIG. 1  with the disposable probe assembly mounted to the reusable hand piece and having a probe with a piercing tip rotatably attached to a probe tube. 
         FIG. 4  is a front isometric view of the hemostatic ring pad of  FIG. 1 . 
         FIG. 5  is a back isometric view of the hemostatic ring pad of  FIG. 1 . 
         FIG. 6  is a right isometric view of a distal portion of an alternate cylindrical probe with a “soft-walled” vacuum lumen formed by an off-center cutter tube and a freely rotating piercing tip for the biopsy device of  FIG. 1 . 
         FIG. 7  is a right side view in longitudinal vertical cross section through lines  7 - 7  of the alternate cylindrical probe of  FIG. 6 . 
         FIG. 8  is a front view taken in transverse cross section along lines  8 - 8  of the probe of  FIG. 7 . 
         FIG. 9  is an aft view taken in transverse cross section along lines  9 - 9  of the probe of  FIG. 7 . 
         FIG. 10  is an isometric exploded view of the disposable probe assembly of  FIG. 1 . 
         FIG. 11  is a left side view in elevation taken in longitudinal cross section through a probe for the disposable probe assembly of  FIG. 1  inserted into tissue. 
         FIG. 12  is an isometric exploded view of the reusable hand piece of  FIG. 1 . 
         FIG. 13  is a bottom view of the assembled biopsy device of  FIG. 1  taken in horizontal cross section through the probe. 
         FIG. 14  is an isometric view of the probe having dimpled external vacuum holes formed on the disposable probe assembly of  FIG. 1  with a piercing tip omitted and a cutter tube detached. 
         FIG. 15  is an isometric view of an alternate probe having a plurality of longitudinal rows of external vacuum holes for the disposable probe assembly of  FIG. 1  with a piercing tip omitted and a cutter tube detached also having a plurality of longitudinal rows of holes. 
         FIG. 16  is an isometric view of another alternate probe having a longitudinally spaced plurality of transverse external vacuum slots for the disposable probe assembly of  FIG. 1  with a piercing tip omitted and a cutter tube detached also having a plurality of longitudinally spaced plurality of transverse holes. 
         FIG. 17  is an isometric view of an additional alternate probe having a plurality of longitudinal external vacuum slots aligned into radially spaced longitudinal rows for the disposable probe assembly of  FIG. 1  with a piercing tip omitted and a cutter tube detached also having a plurality of longitudinal slots. 
         FIG. 18  is an isometric view of a further alternate probe having a plurality of parallel, spiraled external vacuum slots for the disposable probe assembly of  FIG. 1  with a piercing tip omitted and a cutter tube detached also having a plurality of spiraled slots. 
         FIG. 19  is an isometric view of yet another additional alternate probe having a plurality of longitudinal rows of reduced diameter external vacuum holes for the disposable probe assembly of  FIG. 1  with a piercing tip omitted and a cutter tube detached also having a plurality of longitudinal rows of reduced diameter holes. 
         FIG. 20  is an isometric view of yet a further alternative probe having a plurality of longitudinal rows of external vacuum holes with diameters graduated with relation to longitudinal distance along the shaft for the disposable probe assembly of  FIG. 1  with a piercing tip omitted. 
         FIG. 21  is a left side view of the probe of  FIG. 15  in longitudinal vertical cross section and inserted into tissue with cutter tube advanced to close a side aperture and with a sample retraction straw with internal indicator tube retracted exposing internal vacuum holes partially aligned with external vacuum holes. 
         FIG. 22  is a left side view of the probe of  FIG. 20  in longitudinal vertical cross section with the cutter tube retracted and vacuum assistance prolapsing tissue into the side aperture and removing bleeding around the probe. 
         FIG. 23  is a left side view of the probe of  FIG. 22  in longitudinal vertical cross section with the cutter tube advanced to sever a tissue sample. 
         FIG. 24  is a left side view of the probe of  FIG. 23  in longitudinal vertical cross section with the cutter tube advanced a second time severing a second tissue sample with a sample retraction straw advanced within the cutter tube to capture both tissue samples, the latter urging the indicator tube aft. 
         FIG. 25  is an isometric short aperture sleeve with adjustable hemostatic ring for the biopsy device of  FIG. 1 . 
         FIG. 26  is a left side view of the probe of  FIG. 6  in longitudinal cross section with the cutter tube advanced to sever a second tissue sample close to the skin with a side aperture sleeve with adjustable hemostatic ring to avoid skin gouging by the cutter tube. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     In  FIGS. 1-2 , a biopsy device  10  has a reusable hand piece  11  and a disposable probe assembly  12  that enables economical taking of multiple percutaneous core biopsy samples through a core biopsy needle (probe)  13  that is inserted into tissue. With particular reference to  FIG. 1 , vacuum assisted multiple tissue sample biopsy and retrieval is enabled by a vacuum source  14  (e.g., standard medical vacuum pump or wall-mounted vacuum access port). Advantageously, bleeding and fluid management is enhanced by drawing fluid through external vacuum holes  15  formed distally in the probe  13  of the disposable probe assembly  12  through a first interfacing vacuum conduit  16   a  which connects the vacuum source  14  to a first port  17   a  of a vacuum canister  18  for catching extracted fluids and a second interfacing vacuum conduit  16   b  which connects a second port  17   b  of the vacuum canister  18  to the disposable probe assembly  12 . 
     In  FIGS. 3-5 , bleeding and fluid management is further enhanced by proximally positioning a disk-shaped hemostatic ring pad  19  over the probe  13  positioned away from a housing  20  of the reusable hand piece  11  to abut an external opening formed through the skin (not shown). A front absorbent surface  19   a  of the hemostatic ring pad  19  absorbs fluid and resiliently contacts the skin. An opaque and impermeable back surface (e.g., dark thermoplastic)  19   b  of the hemostatic ring pad  19  supports the front absorbent surface  19   a , obscures patient view of absorbed blood, and completes a pneumatic seal over the opening. The hemostatic ring pad  19  may frictionally engage the probe  13 . In order to accommodate a range of sizes of probes  13 , a through hole may be formed by inserting the probe  13  through the hemostatic ring pad  19 . For instance, the sterility of the absorbent material may be maintained by packing that is adhesively attached to a front outer ring of the back surface  19   b . The remaining adhesive may facilitate placement of the hemostatic ring pad at a desired insertion point on the skin a scored central portion of the hemostatic ring pad  19  helps locate the insertion point of the probe  13 . 
     It should be appreciated that although the illustrative version is disk-shaped, it a hemostatic pad consistent with aspects of the present invention may have various geometric shapes. In addition, the absorbent material may be omitted relying upon compression asserted by the back surface. Alternatively, the backing may be omitted relying solely upon absorption or the inherent stiffness of the absorbent material. Further, in some applications it may be desired not to use an opaque backing material but rather a translucent or transparent material so as to view the amount of external bleeding. As an alternative to the hemostatic ring pad  19  frictionally engaging the probe  13 , locking features may be incorporated between a hemostatic ring pad and a probe to locking the hemostatic ring pad at a proximal position indicating full insertion. 
     Returning to  FIGS. 1-2 , in the illustrative version, the hand piece  11  is self-powered and suitable for use in conjunction with ultrasonic diagnostic imaging. The disposable probe assembly  12  reduces the portion of biopsy device  10  that requires protective packaging to avoid contact with sharp surfaces and to keep it sterile prior to use. Further economy is accomplished by reducing the portion of the biopsy device  10  that is disposed as medical waste between uses. Movable components of the disposable probe assembly  12  are advantageously locked until mounted in an access trough  21  ( FIG. 1 ) formed in the housing  20  of the reusable hand piece  11 . It should be appreciated that one or more standard mechanical, pneumatic, or electrical latches (not shown) may be integrated into the biopsy device  10  to secure the disposable probe assembly  12  to the reusable hand piece  11 . 
     In  FIGS. 1-3  and  10 - 11 , the disposable probe assembly  12  includes a substantially rectangular cover  22  sized to close the access trough recess  21  ( FIG. 1 ). An end slot  24  formed in the housing  20  is closed by a probe union sleeve  26  attached to an inner surface  27  of the substantially rectangular cover  22 . The core biopsy needle (“probe”) assembly  13  passes longitudinally through the probe union sleeve  26  and is formed by a probe tube  30  with underlying vacuum lumen  32  that communicates with a side aperture  34  through inter lumen holes  35  ( FIG. 11 ) near a distal opening  36  of the probe tube  30  that is closed by a piercing tip  38 . A cutter tube  40  is sized to closely fit and translate within an inner diameter (i.e., cutter lumen) of the probe tube  30 . Cutter holes  39  near a distal end  41  of the cutter tube  40  may be included allow bleeding and fluid management through the cutter tube  40 . The cutter tube  40  has a longitudinal length sufficient to close the side aperture  34  with a proximal end  42  extending from the probe union sleeve  26  to attach to a cutter gear  44 , as depicted in  FIGS. 2 ,  10 . This non-cylindrical probe  13  includes one passage that passes through the cutter tube  40  that is encompassed closely by the probe tube  30  and includes a “hard-walled” vacuum (lateral) lumen  32  that is under slung and attached to the probe tube  30 , communicating with the other passage proximate to the side aperture  34 . 
     In  FIGS. 6-9 , an alternate cylindrical probe  13 ′ for the disposable probe assembly  12  of  FIG. 1  advantageously incorporates a piercing tip  38 ′ attached at a proximal circular external recess  37 ′ ( FIG. 7 ) for free rotation about its longitudinal axis to a distal opening in a probe tube  30 ′. Thereby, desired non-conical cutting surfaces may be incorporated that reduce the insertion forces that do not impede rotation of the probe tube  30 ′. With particular reference to  FIG. 7 , the cylindrical distal end of the probe tube  30 ′ ends in an outer race  46 ′ proximal to a recessed lip  47 ′. The piercing tip  38 ′ is formed by a cylindrical base  48 ′ attached to a split cone tip  49 ′ that receives a triangular blade  51 ′ held by beveled pin  59 ′. A cylindrical collar  53 ′ grips the cylindrical base  48 ′ and has proximal inward lip  55 ′ that resides within the outer race  46 ′ of the probe tube  30 ′. A bearing  57 ′ between the recessed lip  47 ′ of the probe tube  30 ′ and the cylindrical base  48 ′ of the piercing tip  38 ′ enhances low friction rotation. Thus, a cutting surface such as the triangular blade  51 ′ may be selected for reduced insertion force, etc., yet not impede rotation of the side aperture  34 ′ of the probe tube  30 ′. 
     In this illustrative version, an axially off-center cutter tube  40 ′ ( FIGS. 7-8 ) within the probe tube  30 ′ acts as a “soft-wall”, defining first and second fluid passages that are separated longitudinally within the probe tube  30 ′ that distally communicate with each other at a side aperture  34 ′ formed in the probe tube  30 ′. A first fluid passage is defined within the cutter tube  40 ′ and the second fluid passage is defined within the probe tube  30 ′ but outside of cutter tube  40 ′. Fluid communication between the fluid passages is enhanced by a concave proximal end  43 ′ of piercing tip  38 ′ and cutter holes  39 ′. 
     Bleeding and fluid management is also enhanced by a central fluid cavity  61 ′ that communicates between the distal opening  36 ′ of the probe tube  30 ′ and small fluid passages  45 ′ formed in the split cone tip  49 ′ of the piercing tip  38 ′ that transition from the concave proximal end  43 ′ to an exterior of the piercing tip  38 ′. 
     With particular reference to  FIG. 10 , proximal to the probe union sleeve  26  is an elongate slot  50  that is part of a vacuum assist valve assembly  52 . The cutter gear  44  includes distal and proximal annular recesses  54 ,  56  flanking spur gear teeth  58  that engage the reusable hand piece  11  as described below. A more distal annular recess  60  is gripped by a post  62  that is engaged to longitudinally translate in an elongate post slot  64  of a distal portion  66  of a vacuum valve actuator  68 . A cylindrical proximal portion  70  of the vacuum valve actuator  68  has distal and proximal O-ring grooves  72 ,  73  that respectively retain distal and proximal dynamic O-ring seals  74 ,  75  that move within a distally open cylindrical valve bore  76  of a valve body  78  molded onto an outer surface  79  of the substantially rectangular cover  22  ( FIG. 1 ). 
     With particular reference to  FIG. 1 , as described and depicted in the cross referenced patent application Ser. No. 11/198,558 incorporated by reference above, the vacuum valve actuator  68  selectively allows communication between a proximal port  80 , a center port  82 , and a distal port  84  ( FIG. 2 ). In particular, with the cutter gear  44  retracted, the proximal and center ports  80 ,  82  are in communication. With the cutter gear translated distally, the center and distal ports  82 ,  84  communicate. The center port  82  is attached to a distal vacuum conduit  86  whose other end is connected through the rectangular cover  22  to the probe union sleeve  26 . It should be appreciated that the probe union sleeve  26  includes pneumatic passages that communicate between a proximal end of the vacuum lumen  32  and the distal vacuum conduit  86 . The distal port  84  is attached to a hose nib  88  that is exposed to atmospheric pressure. Hose nib  88  may include an air and/or saline filter. Alternatively, hose nib  88  may be connected to a positive pressure source (e.g., fluid pump) or a negative pressure source (e.g., vacuum pump, syringe) to aspirate fluids. Likewise, hose nib  88  may be used to lavage the tissue cavity with saline, pain medication, or bleeding control fluids. The proximal port  80  communicates through a proximal vacuum conduit  90  to the interfacing vacuum conduit  16   a.    
     It should be appreciated that any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated material does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein, will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material. 
     With further reference to  FIGS. 2-3  and  10 - 11 , a sample extraction feature is incorporated so that multiple samples may be made without the need to remove the probe  13  from tissue nor even to full retract the cutter tube  40  to retract a tissue specimen to the reusable hand piece  11 . With particular reference to  FIG. 10 , this feature is accomplished with a stacking straw assembly  100 . An elongate straw  102  is scored down its length on opposite sides by grooves  104  defining first and second straw halves  106 ,  108 , whose respective proximal, outer surfaces  110 ,  112  are attached to triangular grips  114 ,  116 , respectively. A locking strip  118  extends distally from one triangular grip  114  and is attached along a proximal portion of the first straw half  106 . 
     Distal and proximal tabs  120 ,  122  extend from the inner surface  27  of the substantially rectangular cover  22 , each having a respective through hole  124 ,  126  through which the stacking straw assembly  100  is inserted. The through holes  124 ,  126  are shaped to allow the locking strip  118  to rotate ninety (90) degrees. A bayonet locking member  130  also extends from the inner surface  27  of the substantially rectangular cover  22  just distal and laterally offset from the through hole  124  of the distal tab  120  to lock into an alignment locking slot  132  in the locking strip  118  when laterally rotated. The bayonet locking member  130  prevents axial movement of the stacking straw assembly  100 . The cutter gear  44  and cutter tube  40  cannot move proximally due to contact with the stacking straw assembly  100  and cannot move distally due to contact with the probe union sleeve  26 . By securing both the cutter gear  44  and the stacking straw assembly  100  in a full distal axial position, the disposable probe assembly  12  is aligned to engage the components of the reusable hand piece  11  as described below. Distal to the alignment locking slot  132 , a rectangular recess  134 , formed in the locking strip  118 , defines a distal-most locking finger  136  for engaging components of the reusable hand piece  11  that positions the stacking straw assembly  100  as described below. In  FIGS. 10-11 , an indicator tube  150  has a stacked cone-shaped outer surface  152  ( FIG. 11 ) that slides within the elongate straw  104  that in turn slides within the cutter tube  40 . 
     An alternative sample retrieval approach (“proximal stacker”) is also described in the aforementioned patent application Ser. No. 11/198,558 that uses vacuum without a stacking straw  104  (not shown). In addition, a similar sample holding portion that does not use a stacking straw  104  for retrieval is described in five commonly-owned and co-pending U.S. patent application Ser. No. 10/953,834, “Biopsy Apparatus and Method”, END-5469; Ser. No. 10/953,904, “Improved Biopsy Apparatus and Method”, END 5470; Ser. No. 10/953,397, “Fluid Control for Biopsy Device”, END 5471; Ser. No. 10/953,395, “Biopsy Device with Sample Storage”, END 5472; and Ser. No. 10/953,389, “Cutter for Biopsy Device”, END 5473, all to Hibner et al. and filed on 29 Sep. 2004, the disclosures of which are hereby incorporated by reference in their entirety. 
     It should be appreciated that with the benefit of the present disclosure, various configurations of internal and external vacuum holes may be incorporated into a probe consistent with aspects of the invention in order to achieve tissue prolapse, sample retrieval, and bleeding and fluid management. It should also be appreciated that the probe  13  defines first and second fluid passages that are separated longitudinally within the probe  13  and distally communicate with each other at the side aperture  34 . In the illustrative version, the first fluid passage is defined within the cutter tube  40  and the second fluid passage is defined within the lateral lumen  32  that is “hard walled” apart from a cylindrical portion of the cutter lumen of the probe tube  35 . However, for a cylindrical probe tube (not shown), a cutter tube may be axially offset within the cutter lumen of the probe tube such that the cutter tube may separate the first and second fluid passages, especially if the cutter tube need not be retracted for retraction of samples (e.g., vacuum retraction, straw retraction, single sample per insertion devices). 
     With reference to  FIGS. 1-2 ,  13 - 15 , the reusable hand piece  11 , as described in previously cross referenced U.S. patent application Ser. No. 11/198,558, includes four user controls aligned on a top surface  160  of the housing  20 , specifically from most distal to most proximal: a forward motor rotation key  162 , a reverse motor rotation key  164 , a saline flush key  166  and a slide button  168  for selecting insertion mode or sample taking mode. The keys  162 - 166  control a control circuit  170 , which may include integral power storage (e.g., batteries, fuel cell, etc.) for untethered use. With particular reference to  FIG. 15 , the forward motor rotation key  162  causes a DC motor  172  to rotate its motor output shaft  174  in a forward rotation. A slide spur gear  176  includes an internal keyed engagement with a longitudinal key groove  178  on the motor output shaft  174  that allows longitudinal positioning by the slide button  168 . In particular, fore and aft brackets  180 ,  182  of the slide button  168  engage distal and aft annular grooves  184 ,  186  that flank spur gear teeth  188  of the slide spur gear  176 . 
     When the slide button  168  is moved distally, the slide spur gear  176  engages a tissue penetration gear  190  that spins on a common shaft centerline  192  forward of a gearbox input gear  196 . Gearbox input gear  196  consists of a distal small gear  198  and a proximal large gear  200 . The tissue penetration gear  190  has spur gear teeth  206  that engage the slide spur gear  176 . A frame post  212  projects proximally from an aft wall  213  of a frame  204  with a strike pin  214  projecting upwardly from the frame post  212 . A circular cam wheel  216  is attached to a distal side of the tissue penetration gear  190 . Rotating the tissue penetration gear  190  urges the strike pin  214 , and thus the frame  204 , proximally. Left and right spring cavities  218 ,  220  (when viewed from above), formed longitudinally in distal corners of the frame  204 , respectively receive inwardly projecting left and right tabs  222 ,  224  ( FIG. 1 ) from the housing  20  and receive left and right compression springs  226 ,  228 . In particular, a distal end of each compression spring  226 ,  228  presses against a distal inner surface of the respective spring cavity  218 ,  220 . A proximal end of each compression spring  226 ,  288  is grounded against a respective tab of the housing  20 . Thus, the frame  204  is biased distally within the housing  20 . Movement of the frame  204  proximally compresses these compression springs  226 ,  228  that thereafter assert a restoring force. 
     When the slide button  168  is moved proximally, the slide spear gear  176  is moved into engagement with the gearbox input gear  196 , specifically the distal small gear  198 , which engages and turns a translation large input gear  230  whose shaft  232  passes through the aft wall  213  of the frame  204 . The proximal large gear  200  of the gearbox input gear  196  engages and turns a rotation small input gear  236  whose shaft  238  passes through the aft wall  213 . The frame  204  includes a carriage recess  240 , defined between a partition  242  and the aft wall  213 . The carriage recess  240  contains longitudinally aligned left side lead (translation) screw  244  and right-side rotation spur gear  246  that are attached for rotation respectively with the shafts  232 ,  238 . The partition  242  is positioned aft of the left and right tabs  222 ,  224  of the housing  20  and also defines in part the left and right spring cavities  218 ,  220 . An unlocking cam  247  projects proximally from and is longitudinally centered on the aft wall  234  above the position of the lead (translation) screw  244  and rotation spur gear  246 . 
     The rotation spur gear  246  engages the cutter gear  44  when the disposable probe assembly  12  is inserted, imparting a rotation as the cutter tube  40  and cutter gear  44  translate longitudinally in response to the rotation of the lead (translation) screw  244 . This translation is caused by lead screw threads  248 . In particular, a distal carriage (cutter carriage)  250  is longitudinally moved on the lead screw threads  248 . Distal and proximal J-hook extensions  252 ,  254  project downwardly from the distal carriage  250  to engage the distal and proximal annular recesses  54 ,  56  of the cutter gear  44 . Distal of the distal carriage  250 , a biasing spring  256  urges against the distal carriage  250 , which assists in engagement of the lead screw threads  248  with the distal carriage  250 . 
     A sliding pin  260  has a proximal carriage sliding pin retainer  266  attached to a proximal carriage  258 . A shaft  264  of the sliding pin  260  also passes through a distal carriage sliding pin retainer  270  attached to the distal carriage  250 . Sliding pin  260  has a proximal end  262  and a distal end  268  to prevent the sliding pin  260  from disengaging from the carriage sliding pin retainers  266 ,  270 . A sliding pin spring  272  resides on the sliding pin  260  and is constrained at each end by carriage sliding pin retainers  266 ,  270 . 
     With the components of  FIGS. 1-5  and  10 - 13  now introduced, a sequence of use of the biopsy device  10  will be described. The interfacing vacuum lumen  16   a  is attached to the disposable probe assembly  12  ( FIGS. 1-2 ). The disposable probe assembly  12  is installed into the reusable hand piece  11  ( FIGS. 3 ,  13 ). In so doing, the distal cutter carriage  250  engages the cutter gear  44 , the proximal straw carriage  258  engages the locking strip  118  of the stacking straw assembly  100 , and the bayonet locking member  130  is deflected by the unlocking cam  247 , longitudinally unlocking from the alignment locking slot  132  of the locking strip  118  allowing longitudinal movement of the cutter tube  40  and the straw stacking assembly  100 . 
     With the biopsy device  10  assembled, the reusable handpiece  11  is manipulated to insert the piercing tip  38  of the core biopsy needle (probe) assembly  13  into tissue. Penetration of dense tissue is assisted by moving the slide button  168  distally to a “tissue insertion mode” wherein the slide spur gear  176  engages the tissue penetration gear  190 . Depression of the forward motor rotation key  162  turns these gears  176 ,  190  causing the circular cam wheel  216  to turn against strike pin  214  that creates proximal longitudinal motion of frame  204  and the attached core biopsy needle (probe) assembly  13  of approximately 0.1 inch at a rotation rate of 7 cycles per second. Left and right compression springs  226 ,  228  provide the restoring distal longitudinal motion to frame  204  and probe assembly  28  as left and right compression springs  226 ,  228  are repeatedly compressed between the distal surface of the left and right spring cavities  218 ,  220  of the frame  204  and the left and right tabs  222 ,  224  of the housing  20 . The restoring distal longitudinal motion to frame  204  and core biopsy needle (probe) assembly  28  result in a corresponding distal motion of piecing tip  38  that assists in penetrating tissue. 
     Bleeding and fluid management is enhanced by vacuum being drawn through the external vacuum holes  15  into the vacuum lumen  32 . With reference to  FIGS. 11 and 14 , the external vacuum holes  15  reside within a protruding dimple structure  300  formed in the lateral lumen  32  which mitigates a tendency of adjacent tissue to be drawn into and plug an external vacuum hole  15 . In addition, the cutter holes  39  formed in a distal end  41  of the cutter tube  40  assist in drawing fluid when the cutter tube  40  is advanced, otherwise closing the side aperture  34 . 
     In  FIG. 15 , an alternate probe  13   a  has a plurality of longitudinal rows of external vacuum holes  15   a . A cutter tube  40   a  has a plurality of longitudinal rows of cutter holes  39   a  for assisting in bleeding and fluid management. In addition, the exterior of a probe tube  30   a  has some of the vacuum holes  15   a , in addition to those in a vacuum lumen  32   a , such that cutter holes  39   a  in the cutter tube  40   a  may readily communicate externally. 
     In  FIG. 16 , another alternate probe  13   b  has a longitudinally spaced plurality of transverse external vacuum slots  15   b  formed in a vacuum lumen  32   b  but not a probe tube  30   b . A cutter tube  40   b  also has a plurality of longitudinally spaced plurality of transverse cutter slots  39   b.    
     In  FIG. 17 , an additional alternate probe  13   c  has a plurality of longitudinal external vacuum slots  15   c  formed in both a vacuum lumen  32   c  and a probe tube  30   c . A cutter tube  40   c  also has a plurality of longitudinal cutter slots  39   c.    
     In  FIG. 18 , a further alternate probe  13   d  has a plurality of parallel, spiraled external vacuum slots  15   d  formed in a vacuum lumen  32   d  but not a probe tube  30   d . A cutter tube  40   d  also has a plurality of spiraled cutter slots  39   d.    
     In  FIG. 19 , yet another additional alternate probe  13   e  has a plurality of longitudinal rows of reduced diameter external vacuum holes  15   e . A cutter tube  40   e  has a plurality of longitudinal rows of reduced diameter cutter holes  39   e  for assisting in bleeding and fluid management. In addition, the exterior of a probe tube  30   e  has some of the vacuum holes  15   e  in addition to those in a vacuum lumen  32   e  such that reduced diameter cutter holes  39   e  in the cutter tube  40   e  may readily communicate externally. 
     In  FIG. 20 , yet a further alternative probe  13   f  has a plurality of longitudinal rows of graduated diameter external vacuum holes  15   f - 15   h  in a probe tube  30   f , with the largest external vacuum holes  15   h  most distal, the smallest external vacuum holes  15   f  most proximal, and the mid-sized external vacuum holes  15   g  in between. The cross sectional area of the holes  15   f - h  are selected to correspond with a typical vacuum pressure drop as a function of longitudinal position on the probe tube  30   f , thereby tending to avoid the likelihood of higher vacuum proximally tending to suck in tissue. 
     In use, in  FIG. 21 , the probe  13   a  is inserted into body tissue  304  with a hole formed by the piercing tip  38 . The cutter tube  40   a  is distally advanced to close the side aperture  34  in the probe tube  30   a  to reduce tissue trauma during insertion. The stacking straw assembly  100  is retracted to an initial position. Vacuum assistance is present through both the cutter tube  40   a  and the vacuum lumen  32   b  during insertion, encouraging bodily fluids (e.g., blood)  306  to be drawn into external vacuum holes  15   a  and additionally into cutter holes  39   a  being drawn aft for collection, and with a sample retraction straw with internal indicator tube retracted exposing internal vacuum holes partially aligned with external vacuum holes. Bleeding closer to an external opening in skin tissue  308  that is not drawn into the probe  13   a  is captured into the front absorbent material  19   a  of the hemostatic disk-shaped ring pad  19  that encompasses and frictionally grips the probe  13   a.    
     In  FIG. 22 , the cutter tube  40   a  is retracted, allowing vacuum assistance from both the cutter tube  40   a  and vacuum lumen  32   a  to prolapse tissue  304  into the side aperture  34  of the probe tube  30   a . In  FIG. 23 , distal advancement of the cutter tube  40   a  has resulted in severing of a first tissue sample  304   a  encompassed therein. In  FIG. 24 , the elongate straw  102  has been distally advanced within the cutter tube  40   a , which in the interim has been reciprocated another time, to encompass and capture the first tissue sample  304   a  as well as a second tissue sample  304   b  which has been severed in the interim by another reciprocation of the cutter tube  40   a . The presence of the tissue samples  304   a ,  304   b  in the elongate straw  102  extrudes aft the indicator straw  150 . 
     In  FIGS. 25-26 , a sleeve  400  advantageously assists in bleeding control as well as enabling the taking of biopsy samples of a lesion  402  close to the surface wherein the side aperture  34  is partially exposed. A taper distal end  404  of a cylindrical tube  406  of the sleeve  400  may be longitudinally positioned by gripping a pushing a proximal disk flange  408 . In  FIG. 26 , the sleeve  400  has been slid overtop of the exposed portion of the side aperture  34 ′ of the probe  13   f  so that the cutter  40   a  doesn&#39;t gouge skin as it translates from outside of the body across the side aperture  34 ′. The sleeve  400  may further plug the external opening in the skin to further reduce external bleeding, not only with its increased diameter of the cylindrical tube  406  but also by positioning a hemostatic ring  410 . To that end, an absorbent ring  412  frictionally engages the cylindrical tube  406 . To assist in positioning the absorbent ring  412 , a rigid backplane  414  attached proximally to the absorbent ring  412  may be included for moving the hemostatic ring  412  into contact with the skin. 
     While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art given the benefit of the present disclosure that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the spirit and scope of the appended claims. Additionally, each element described in relation to the invention may be alternatively described as a means for performing that element&#39;s function. 
     For example, bleeding and fluid management may be enhanced by flushing the external vacuum holes  15  to remove tissue debris and coagulated blood, such as described in the co-pending and commonly-owned U.S. patent application Ser. No. 11/344,879, “Biopsy Device with Replaceable Probe Incorporating Static Vacuum Source Dual Valve Sampling Stacking Retrieval and Saline Flush” to Hibner, filed 1 Feb. 2006, the disclosure of which is hereby incorporated by reference in its entirety. 
     For another example, in some applications a sleeve with a piercing tip or a sleeve with an open distal end closed by an introducer stylet (not shown) are used to penetrate tissue prior to insertion of a probe of a biopsy device for taking the biopsy samples. Consistent with aspects of the present invention, pneumatic fluid passages may be formed in the sleeve and/or introducer stylet that communicate proximally with a vacuum source for bleeding and fluid management. In addition, a hemostatic disc-shaped ring pad may be added to the sleeve to further assist in preventing or obscuring external bleeding. 
     As an additional example, while a fixed ratio translation/rotation cutter tube  40  is depicted herein, applications consistent with the present invention may not rotate the cutter tube or selectively rotate the cutter tube to present sampling holes to the side aperture or to a hole in an encompassing probe tube to assist in bleeding/fluid management. Rotating these holes to be blocked during other portions of the procedure may then enhance the available suction for retraction of a tissue sample, for instance.