Mou v. City of San Jose et al

Filing 1347

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Mou v. City of San Jose et al Doc. 1347 Att. 7 Case5:07-cv-05740-JF Document25-8 Filed06/24/08 Page1 of 20 I1111111111111l11111111u11111111111111I 11l1111111l l 1 1111l1111111 l1 l ll l USOOG3311G6Bl (12) Burbank et al. United States Patent BREAST BIOPSY SYSTEM AND METHOD Inventors: Fred H. Burbank, San Juan Capistrano; Michael L Jones, Capistrano Beach; Paul Lubock Laguna Niyel, all of CA (US) Assignee: SenoHx, Inc, A i s 0 Vicjo, C A (US) Notice: Subject to any dixlaimer, the term of this patent i extended or adjusted under 35 s U.S.C. 154@) by 0 days. (io) (4s) Patent No.: US 6,331,166 B1 Date of Patent: Dec 18,2001 KTIGB941 01536 PcT/GB94/ 01537 95/02371 711994 P O ) . 7fl994 P O ) . 111995 P O ) . OTHER PUBLICATIONS "The Loop Elec~rode:a New Device for USguided Interstitial Tissue Ablation Using Radio frequency Electrosurgery-An Animal Study" 1996 Blackwell Science b d . Min Incns Ther & Allied Techno1 pp. 5511-516. (List continued on next page.) Appl. No.: 09/057,303 Filed: Apr. 8,1998 Prinlory E m n i n e r - M a x Hindenburg (74) Afforney, Agenf, or Firnz-Coudert Brothers u9 (57) ABS`J'RACT Related U S Application Data .. Provisional applicalion No. 601076,973, filed on Mar. 3, 1998. Int. C1? US. CI. Field of Search References Cited A6lB 5/00 6UU/567; 606/45 h00:5&4-567; 606145-52 US. PATENT DOCUMENTS 20280 ,3,6 3,805,791 3,955,578 4,205338 4,294,254 4,311,143 4,362,160 4,503,855 4,576,162 311936 4/1974 511976 511980 1011981 111982 1211982 311985 311986, Wappler e a]. . ( Seuberlh et al. . Chamness et al. . Bitrolf . Chamness . Komiya . Hihebrandl . Maslank?. McCorkle . (List continucd on next page.) FOREIGN PATENT DOCUMENTS 1952844UA1 0472368A2 2311468A 8119Y5 (DE). 811991 (EP). An apparatus and method are provided for precisely isolating a target lesion in a patient's body tissue, resulting in a high likelihood of "clean" margins about the lesion when it is removed for diagnosis and/or therapy. This approach advantageously will often result in the ability to bolh diagnose and treat a malignant lesion with only a single percutaneous procedure, with no follow-up percutaneous or surgical procedure required, while minimizing the risk of migration of possibly cancsrous 4 1 s from the lesion to surrounding tissue or the bloodstream. In particular, (he apparatus comprises a biopsy instrument having a distal end adapted for entry into the patient's body, a longitudinal shaft, and a cutting element disposed along the shaft. The cutting clement is actualable between a radially retractcd position and a radially extendcd posilion. Advantageously, the instrument is rotatable about its axis in the radially extended position to isolale a desired tissue specimen from surrounding tissue by defining a peripheral margin about the lissue specimen. Once the lissue specimen is isolated, it may be segmented by further manipulation of the cutting element, aficr which the tissuc scgmcnts are preferably individually rcmovcd from thc paticnt's body through a cannula or the like. Alternatively, the hpecimen may be encapsulated and removed as an i n k t piece. 33 Claims, 11 Drawing Sheets 2/1997 (GB). NE0 02257 Dockets.Justia.com Case5:07-cv-05740-JF Document25-8 Filed06/24/08 Page2 of 20 US 6,331,166 R1 Page 2 US. PAlENT DOCUMENTS 4,638,802 4,718,419 4,724,836 5,Oq7,9oa 5,024,617 5,035,696 5,064,424 5,066,295 5,078,716 1111991 in992 5,080,660 111992 5,158,561 10/1992 5,163,938 1111992 5,196,007 311993 5,201,732 411993 ~,mi,74i 411993 5,207,686 511993 5,224,488 711993 5,312,400 511994 5,318,564 611994 5,323,768 611994 5,324,288 GI1994 5,335,671 811994 5,344,420 911994 5,376,094 12/1994 5,380,321 111995 5,395,312 311995 5,415,656 511995 1111991 111987 111988 Ul988 411991 6/1991 711991 Okada. Okada Okada. Rydell . Karpiel Rydell Hilrulf . Kozak el . . . a]. D~II. . Buelna . Rydell e~ al. . Kambara et al. . EIiman el al.. P a M s el al. . ~uiebohn. Dolgin. Neufier ............................... R d k S - al. . 9 Eggcrs . Sail0 el al. . Billings el al. . Clemrnl 5,417,697 5,423,814 5,437,665 5,441,503 5,46z553 5,484,436 5,501,654 5,526,822 5,542,948 5,611,803 5,643,282 5,649>47 5,665,085 5,674,184 5,769,aSC 5,794,626 600/564 1011W5 Dolgin . 111996 Eggea el al. . 3ll99G Rilla et al. . 611996 Bu&dnk e ai. l 811936 Weaver et al. . 31199% Heaven el al. . 711997 liieturakis. 7/l997 Ritcharl el al. 911997 Nardclla 1011997 Hassler, Jr., GI1998 Ritcbarl el al. 811998 Kieturakis .... .VI995 Wilket al.. 6/l995 Zhu cl al. . 8ll995 Munro. 8!1995 Considine el al. ' . 1281754 . ........... 128l7.54 128I753 128/754 ........... OTHER PUBLICATIONS English translation of German Applicalion DE 195 28 440 Al, published Aug. 2, 1995. Arrnslron J. S. el al., "DiiTerenlial marking of excision planes in screzned hreasl lesions by organically coloured gelantins [see comments].",Journal of Clinicaf Pdwlog):, (Jul. 1990), 43 (7) 604-7,XP000971447 abstract; tables 1 & 2. Hila1 el al. . Kline. Yoon. Desni. Thon el al. . . * cited by examiner N E 0 02258 Case5:07-cv-05740-JF Document25-8 Filed06/24/08 Page3 of 20 U.S. Patent ~ e is, 2001 c Sheet 1 of 11 US 6,331,166 B1 NE0 02259 Case5:07-cv-05740-JF Document25-8 Filed06/24/08 Page4 of 20 U.S. Patent DW. is, 2001 Sheet 2 of 11 US 6,331,166 B1 NE0 02260 Case5:07-cv-05740-JF Document25-8 Filed06/24/08 Page5 of 20 U.S. Paten Dec 18,2001 Sheet 3 of 11 US 6,331,166 B1 NE0 02261 Case5:07-cv-05740-JF Document25-8 Filed06/24/08 Page6 of 20 U.S. Patent D e c IS, 2001 Sheet 4 of 11 US 6,331,166 B1 NE0 02262 Case5:07-cv-05740-JF Document25-8 Filed06/24/08 Page7 of 20 U.S. Patent D ~ is, 2001 L Sheet 5 of 11 US 6,331,166 B1 NE0 02263 Case5:07-cv-05740-JF Document25-8 Filed06/24/08 Page8 of 20 .. . . U.S. Patent D ~ Cis, 2001 . Sheet 6 of 11 US 6,331,166 B1 NE0 02264 Case5:07-cv-05740-JF Document25-8 Filed06/24/08 Page9 of 20 U.S. Patent Dec. 18,2001 Sheet 7 of 11 US 6,331,166 3 1 5 Y ' 30 I NE0 02265 Case5:07-cv-05740-JF Document25-8 Filed06/24/08 Page10 of 20 U.S. Patent DW. is, 2001 Sheet S of 11 US 6,331,166 B1 NE0 02266 Case5:07-cv-05740-JF Document25-8 Filed06/24/08 Page11 of 20 U.S. Patent . D ~ Cis, 2001 . Sheet 9 of 11 US 6,331,166 B1 306, NE0 02267 Case5:07-cv-05740-JF Document25-8 Filed06/24/08 Page12 of 20 U.S. Patent D ~ L 2001 is, Sheet 10 of 11 US 6,331,166 B1 NE0 02268 Case5:07-cv-05740-JF Document25-8 Filed06/24/08 Page13 of 20 U.S. Patent DW i s , 2001 Sheet 11 of 11 US 6,331,166 B1 1Oa 190 160 /J- 14a NE0 02269 Case5:07-cv-05740-JF Document25-8 Filed06/24/08 Page14 of 20 US 6,331,166 Bl 1 BREAST BIOPSY SYSTEM AND METHOD 2 into the breast. The tip of the probe is configured with a laterally disposed sampling notch for capturing tissue samples. Orientation of Ihe sample notch is directed by the CROSS REFERENCE To RELATED physician, who uses a lhumbwheel lo direct tissue sampling APPLICATIONS s in any direction about the circumference of the probe. A The present application is a non-provisional application of hollow cylindrical cutter SeverS and lransports tissue the provisional patent application U.S. Ser. No. 60/076,973, samples to a tissue collection chamber for later testing. "Breast Biopsy System and Method" Gled Mar. 3, 1998, While this type of system functions very well as a core from which priority is claimed under 35 U.S.C. 5 119(e). biopsi device, there are occasions when it may be useful to 1 have the capability of acquiring a relatively large inlact 0 RELD OF THE ll&ENTlON tissue sample. One such core biopsy device is disclosed in The present invention relates to methods and dtvicxs for U S . Pat. No. 5,111,828, lo Komberg et al., also expressly `removing tissue samples, and more specifically to improved incorporated by reference herein. In the device disclosed by instruments and methods for acquiring soft body tissue. Komherg et al., the tissue receiving port is disposed at the 1s distal end of. the device and is oriented axially rather tban BACKGROUND OF THE INVENTION laterally. A disadvantage of this type of device, however, is the inability to acquire a tissue sample having a crossI t is often desirahle and frequenlly necessary to sample or section larger than h a t of the cannula through which the remove a portion of tissue from humans and other animals, sample will be removed. Additionally, it is difficult, using particularly in Ihe diagnosis and lreatment of patients with cancerous tumors, pre-malignant conditions, and other dis- 20 such a device, which obtains cylindrical shaped specimens, to determine whether an entire lesion of interest is being eases or disorders removed or whether a further procedure will be necessary. Typically, in the case of cancer, parlicularly Cancer of the This is particularly true because most lesions of interest are, breasL there is a great emphasis on early detection and typically spherical in shape, having a diameter of approxidiagnosis throw$ the use of screening modalities, such as 25 maiely 1 cm. I h e only way one can tell whether the entire physical examination, and particularly mammography, lesion has been removed using lhe Kornberg technique is to which is capable of detecting very small abnormalities, often remove and examine the specimen, determining whether nonpalpable. When the physician establishes by means of a each of the margins of the specimen is "clean", meaning that mammogram o r othcr screening modality, such a s there is no evidence of lesion, or "dirty", meaning that lesion ultrasound, that suspicious circumstances exist, a biopsy 30 is evident right 10 the edge of the specimen. Of course, if one must be performed to capture tissue for a definitive diagnoor more specimen margins is "dirty", it is almost a cenainty sis as to wherher the suspicious lesion is cancerous. Biopsy that a portion of the lesion remains in the patient, and if the r may he done by an open o percutaneous technique. Open biopsy test results on the lesion are positive, a further biopsy, which is an invasive surgical procedure using a scalpel and involving direct vision of the target area, 55 surgical procedure will be indicated. I t would be desirable, therefore, to have an apparatus and removes the cntirc mass (cxcisional biopsy) or a part of the method for isolating a target lesion, with a sufficient border mass (incisional biopsy). Percutaneous biopsy, on the other around and beyond the lesion that the likelihood of "clean" hand, is usually done with a needle-like instrument through margins is relatively high. It would further be advantageous a relatively small incision, blindly or with the aid of an LO have an apparatus and method available for initially artificial imaging device, and may he either a fine needle isolating the entire target lesion, by cutting a swath comaspiration (FNA) or a core biopsy. In FNA biopsy, individual pletely about the lesion lo ciil off its blood supply, after cells or clusters of cells are obtained for cytologic examiwhich a furlher procedure is undertaken to remove it from nation and may be prepared such as in a Papanicolaou smear. the patient's body. This approach would help to minimize In core biopsy, as the term suggests, a core or fragment of tissue is obtained for histologic examination which may be 45 the migration of possibly cancerous cells from the lesion to surrounding tissue or bloodstream during the removal prodone via a frozen section or paraffin section. cedure. The lype of biopsy utilized depends in large part on circumstances present with respect lo the patient, including SUMMARY OF THE INkNTION the location of the lesion(s) within the body, and no single procedure is ideal for all cases. However, core biopsy is 50 The present invention addresses the foregoing problems cxtrcmcly uscful in a number of conditions and is bcing used by providing such an apparatus and method for precisely more frequently by the medical profession. isolating a target lesion, resulting in a high likelihood of "clean" margins. This atlvanlageously will olien result in the A very s~~ccessful of image guided percutaneous core lype ability to both diagnose and lreal a malignant lesion with breast biopsy instrument currently available is a vacuumassisted automatic core biopsy device. One such successful 55 only a single percutaneous procedure, with no follow-up percutaneous or surgical procedure required, while minimizbiopsy device is shown and disclosed in U S . Pat. No. ing the risk of migration of possibly cancerous cells from the 5326,822 to Burbank et al, exprcssly incorporated by reflcsion to surrounding tissue or the bloodsueam. erence. herein. This device, known commercially as the More particularly, in one aspect of the invention, a biopsy MAMMOTOMEE Biopsy System, which is available from Ethicon Endo-Surgery, Inc., a division of Johnson .& 60 inslrument is provided for retrieving body tissue, which instrument has a longitudinal axis. The instrument comJohnson, has the capability to actively capture tiswe prior to cutting the tissue. Active capture allows for sampling prises a distal end adapted for entry into a patient's body, a through non-homogeneous tissues. The device is comprised shaft disposed along the axis, and a cutting element disposed along the shaft. The cutting element is actuatablc betwcen a of a disposable probe, a motorized drivc unit, and an integrated vacuum source. The probe is made of stainless 65 radially retracted position and a radially extended position. Advantageously, the instrument is rordlable about its axis in sled and molded plastic and is designed for collection of the radially extended position lo isolate a desired tissue multiple tissue samples with a single insertion of the probe NE0 02270 Case5:07-cv-05740-JF Document25-8 Filed06/24/08 Page15 of 20 US 6,331,166 B1 specimen from surrounding t k e by defining a peripheral margin about the tissue specimen. Once the tissue specimen is isolated. it may be segmented by further manipulation of the culling element. after which the tissue segmenls are preferably individually removed from the patient's body through a cannula o r the like. Alternatively, the Specimen may be encapsulated and removed as-an intact piece. In another aspect of the invention, an instrument is provided for retrieving body tissue, having a lon@~dinal axis and comprising a distal end adapted for entry into a patient's body. The instrument further comprises an element for a specimen that it may be withdrawn as a unit from lhe patient's hdy- The encaFulating preferably comprises a I1lurality Of bands disposed along the instrument axis, each of which are actuatable between a radially retracted position and a radially extended position. In yet aspect Of the invention, a method is disclosed for retrieving a tissue specimen from a patient's body, comprising the steps of inserting an inslrument having axis, and an axially disposed a distal end, a cutting element, inlo the patient's body, that a end is disposed in a tissue region from \h.bjch the so is lo be necutting element is that a ponion thereof is radially outwardly spaced from thc axis of the instrument. Once the cutting element is radially expanded, it is rotated about the axis to cut the tissue and create a peripheral boundary about h e tissue specimen, to isolate the tissue specimen from surrounding tissue in the tissue region. 'Ihe invention, together with additional features and advantages thereof, may best-be understood by reference 10 the following description t&en in conjunction with the accompanying illustrative drawing. , 3 4 FIG. 9 is a schematic view similar to FIG. 8, wherein the distal cutting element is deployed in a second position for isolating a second segment of the target tissue specimen from surrounding tissue; 5 FIG. 10 is a schematic view to FIGS. 8 and 9, wherein the distal cutting elemenl is deployed in a third position for isolating a third segment of the target tissue specimen from surrounding tissue; FIG. 11 is a perspective view illustrating the distal end of 1 a second 0 embodiment of inventive tissue retrieval instrument; . FIG. 12 is a perspcctivc cutaway view of the distal end of the embodiment of FIG. 11, illustrating the internal con,5 s h c t i o n thereof, including tissue wrapping and in their stored position; FIG. 13 is a pcrspeclive cutaway view similar IO that of FIG. 12, wherein the sheath has been retracted in order to deploy the tissue wrapping and shown 2o 12; FIG. 14 is a side schematic view of the distal end of the Of FGS. 11-13> lhe deployment of h e tissue wrapping and cutting elemenk shown in FIG. 12; FIG. 15 is a perspective view illustrating the tissue wrapping and cutting elements of FIGS.12 and 14 in their Position; FIG. 16 is a side view showing the deployed tissue wrapping and cutting elemenk after the distal end of the instrument has bwn rotated to twist the wrapping and culling elements in order to wrap a parget tissue sample; FIG. 17 is a perspective, schematic view of an alternative embodiment of the distal end of the inventive tissue retrieval inslrumenl, wherein the culling elemem of the instrument is in a retracted position; FIG. 18 is a perspective, schematic view similar to FIG. 17, illustrating the culling element in a deployed position for creating cylindrical tissue segments; and PIG. 19 is a perspective, schematic view similar 10 FIGS. 17 and 18, illustrating the cutting element in a deployed Position for creating tissue of vuying heights. DESCKII"l1ON OF THE INVENI'ION 25 30 35 Referring now more parlicularly lo FIG. 1, there is shown 45 Ihe distal end 12 of a f i r s preferred embodiment of an inventive tissue retrieval or biopsy instrument 10. The distal end l2 preferably comprises a wand portion, a lip 14' 'lelip l4 may comprise a lrocar lip, Or> preferably> may an 50 trosurgical (RF) element or wire I 6 which may he energized FIG. is a perspective view from the lop illuslrating lhe by a conventional electrosurgical generator (not shown) in proximal drive unit of FIG. 4, with the top portion of the order facilitate tissue and consequent advanehousing rcmoved in order to show portions of its internal merit of thc inslumcnl a tissue in construction; the patient's body. HG. is a perspective view from Ihe proximal end 5s Proximally of the tip 14 is a shaft 18, preferably lying illustrating the proximal drive unit of FIGS. 4 and 5, with the along an axis 19 (FIG. 1) of the instrument, on which is top portion of the housing removed in order to show poriions disposd a elcmcnl or wire 20, This wire 20 is of its intenial construction; disposed axially along the length of the shaft 18 in its FIG. 7 is a perspective view from the distal end illustrairetract& position (nbt shown), but may be deployed with the tPP 60 outwardly, as shown in FIG. 1. The element 20 is preferably ing the Proximal drive unit of FIGS. podion of tbe housing removed io order I O show portions of conlprised of a wire or rectangular band fabricated of its internal construction; memory `metal such as Nitinol, though stainless steel, FIG. 8 is a,schematicview illustrating the distal end of the tungsten, or other biocompatible materials could also be instrument of FIG. 1 disposed in a tissue region from which cmploycd, if dcsired. The cutting clcment 20 acts as an larget tissue is to be retrieved, wherein the distal cutting 65 eleclrosurgical cutter, energizable by means of R F energy element is deplo'yed in a first position for isolating a Crsl provided by the electrosurgical generator discussed supra. segmenl of a target tissue specimen from surrounding tissue; The instrument 10 may be monopolar, as illustraled in FIG. -7 BRIEF DESCRIPTION OF THE DRAWING FIG. 1 i s a perspective view of the distal end of one preferred embodiment of the inventive tissue relrieval instrument; FIG. 2 is a perspective view illustrating the disbl end of a monopolar embodiment of the inventive tissue. retrieval instrument shown in FIG. 1; similar lo that of FIG, 2, HG. 3 is a illustrating the distal, end of a bipolar embodbent of the inventive tissue retrieval instrument shown in FIG. 1; HG. 4 is a cutaway view from the si& illustrating b e internal ~ n ~ ~ c to f aopresently preferred proximal drive in unit for the inventive tissue instrumen(; NE0 02271 Case5:07-cv-05740-JF Document25-8 Filed06/24/08 Page16 of 20 US 6,331,166 B1 5 2, with the cutting element 20 comprising the active electrode and a return electrode spaced from the instrument 10 and most typically being disposed on the patient'sskin in the form o f a patch electrode on the thigh or back. Alternatively, the instrument 10 may preferably be bipolar, as illusuated in FIG. 3, with the culling element comprising the active electrode and a return electrode 22 being di-sposed on the instrument in close proximity to the active electrode, such as along the shaft 18. With such an amangemen4 a layer of insulation 23 is disposed between the return electrode (comprising a major podion of the surface area of the shaft 18) and the portion of the shaft adjacent to the active electrode, which receives the cutting element W in its retracted position. The bipolar embodiment is generally preferred b e c a w of a greater safety factor and lower power requirements. A plurality of cutting wires 20,,mag be employed if desired, preferably spaced circumferentially about the shaft 18. In some embodiments, it may be preferably to have webs between the cutting elements, to.create a "sail" rather than entire distinct separate cutting elemen6. Rcferring now more pahcularly to FIGS. 4-7, a proximal reusable driver portion 24 for the distal end or disposable wand portion 12 is shown. The driver portion 24 is prefer.ably disposed on a stereotactic rail 26, in known fashion, for guidance of the instrument 10 to a predetermined tissue site using known imaging techniques. Such stereotactic imaging systems are available, for example, from Fischer, lnc. or Lorad, Inc. Alternative imaging systems, such as , mammographic, ultrasonic, a MRI guidance syslems may be used in place of a stereolactic system, if desired. Additionally, the instrument may be guided to the lesion site using an articulating arm system or manually, rather than on a stereotactic rail. The reusable driver portion 24 comprises a housing 28 within which is disposed a coaxial arrangement comprising an outer sheath 30, the shaft 18, and a rod 32 which is attached at its distal end to the cutter element 20. A knob 34 is rotatably attached lo the shaft 18 through a gearing system 35 lo rotate the shaft 18 as desired, for the purpose' of circumferentially orienting and rotating the cutting element 20. Three levers 36, 38, and 40 extend outwardly through slols 42,44, and 46, respectively, in the side of the housing 28. The first lever 36 is actuatable to slide the sheath 30 axially both proximally and distally, for a purpose to be demjbed hereinbelow. The second lever 38 is actualable to move the shaft I S axially in distal and proximal directions, as &sired. l'he third lever 40 is actualable to move the rod 32 axially in distal and proximal directions, as desired. Since the rod 32 is attached at its distal end to the proximal end of the wire cutter 20, movement of the rod 32 in an axial direction also causes the proximal end of the wire cutter 20 to move in an axial direction. Since the distal end of the cutter 20 is anchored to the shafi 18, movement of the proximal end of the cutter element 20 in a distal direction causes the midportion of the cutling element 20 to bow radially outwardly to a radially expanded position, as shown in any of FIGS. 1-3, while movement of the proximal end of the cutter element 20 in a proximal direction causes the midportion of the cutter element 20 lo retract radially to its stowed position, disposed linearly along the axial length of the shaft 18, preferably within a recess 48 (FIG. 1). A advantageous feature of the invention is the employn men1 of a series of stops 5U in the second slot 44,and a series of stops 52 in the third, slot 46, as illustrated in FIGS. 5-7. The stops 50 enable the second lever 38 to be actuated to a plurality of discrete axial positions, which in turn permits the 6 shaft 18 -to be actuated to a corresponding plurality of discrete axial positions for fine tuning the axial position of the electrosurgical cutting element 20. Similarly, the stops 52 enable the third lever 40 to be actuated to a plurality of 5 discrete axial positions, which in turn permits the electrosurgical cutting element 20 to be radially extended to a corresponding plurality of radially extended positions, for a purpose to be d e s c n i d more fully hereinbelow. With reference now more panicularly to FIGS. 8-10, the lo operation of the first preferred embodiment of the inventive device will be explained. Initially, when it is determined that either a diagnostic or therapeutic biopsy procedure is indicated. the distal disposable wand portion 12 of the instrument 30 will be moved axially to a position wherein 15 the distal tip is adjacent 10 and preferably. within a target lesion 54, using the stereotactic rail 26 and associated imaging system. During this process step, wherein gross linear movement of the wand 12 is controlled by the rail system 26, the' electrosurgical cutting element 16 on the 2o distal tip 14 is energized to pierce and cut through the patient's body tisue 56 to permit distal advancement of the wand l2 to the region surrounding the lesion 54. Once the distal tip 14 is generally in the desired position adjacent to or within the large1 lesion 54, using the stereo25 tactic rail 26, the second lever 38 is actuated to provide fine tuning of the axial position of the distal tip 14 relative to the lesion 54, by moving the shaft 18 axially to a desired position, and securing thc lever 38 in an appropriate stop 50 to maintain the desired axial position. This fine axial adjust3o ment of the axial movement of the shaft 18 is performed using appropriate imaging equipment. "lie objective of this process step is to ensure that the distal end of the cutting wire 20 is disposed distally of the distal peripheral edge of the lesion 54, while at the same time the proximal end of the 35 cutting wire 2U is disposed proximally of the proximal peripheral edge of the lesion 54. T i will ensure the ability hs to isolate the entire lesion 54 during the culling procedure, with sufficient margins to minimize the chance that any portion of the lesion inadvertently remains behind in the 40 patient's body following removal thereof. When the distal tip 14 is in the precise position desired by the practitioner, first lever 36, which is normally disposed in a first detent 58 (FIGS. 5 and 6) in the first slot 42, is actuated proximally until it rests in a second detent 60 (FIG. 45 5) in the first slot 42. This action retracts the sheath 30 proximally a sufficient distance to partially uncover the cutting element 20. It should be noted, however, that in some circumgancs it may be desirable lo fully retract the sheath, so that the entire cutting elemen120 is released, in order to 50 create a different cutting geometry. In such a n instance, a detent 61 (FIG. 7) is provided within the slot 42 lo accommodate the lever 36 in the fully proximal position necessary to achicve full axial retraction of the sheath. Additional intermediate detents 60 (not shown) may be provided to 55 retract the sheath to intermediate positions corresponding to various partial radial extension posiljons of the cutting element. After the sheath 30 is relracted as desired, the third lever . 40 may then be actuated distally along the third slot 46 lo an 60 inkrmediate stop 52, thereby causing the rod 32, and therefore the proximal end of the cutting element .20, to move axially a distance equivalent to that traversed by the lever 40.This, of course, results in the partial radial expansion of the cutting element 20 to a n arched or bowed 65 configuration as shown in FIG. 8. The extended configuration of the cutting element 20 may define, when rotated about the instrument axis, a spherical cutting volume, a s , ' NE0 02272 Case5:07-cv-05740-JF Document25-8 Filed06/24/08 Page17 of 20 US 6,331,166 B1 7 8 . shown, or it may be configured to define an elliptical or an orange". Additional radially oriented cutting elements could b . employed as well to funher segment the tissue. e toroidal cutting volume when the cutting element is rotated about the instrument axis 19, rather than a spherical volume. alternative approach 10 segmenting h e &sue speciOf course many other mechanisms for radially expanding men to be retrieved is illusttated in the embodiment shown the culling element 20 may be utilized as well. within the 5 in FIGS. 17-19. In this embodimenl, wherein like elements scope of the invention. For example, since the wire 20 is to those in the embodiment of FIG. 1 are designated by like reference numerals, succeeded by the letter a, there is shown preferably fabricated of a shaped memory or superelastic material, the proximal retraction of the sheath 30, and a tissue retrieval or biopsy instrument loa, having a distal tip resultant release of the wire 20, may be sufficient to cause 14u with an el.ectrosurgical element or Wire 160 for cutting the cutting wire 20 to radially expand lo iis desired position. 10 tissue and thereby permitting advancement of the inslrument Once the cutting element 20 is partially radially expanded inlo a Patient's body. A shaft Or cannula 18U is disposed of the target lesion 54 is along an axis 19u of the instrument. A longitudinal slot 66 as described supra, an inner isolated from surrounding tissue. To complete this step, the i disposed axially along a podion of the length of the s by the elecuosu@cal gencannula IRa. A culling element or wire 20a. which is element 20 is Preferably an e l e c t r m ~ c aCutting elemenl, is disposed l erator (not shown), after which the knob 34 is rotated, either as lo be extendable from and retractable into the slot. The . manually or via a motorized drive mechanism, 10 rotate.tbe cutting element20 through a 360 degree arc. nisrotational cutting element is shown in a retracted position in FIG. 17, and in an extended position in FIGS. 18 and 19. cutting action functions to completely sever the inner lion of the tissue sample from the surrounding tissue, In operation,once the instrument 100 has been positioned so that the distal l i p i s adjacent to a lesion to be removed, in lhereby cutting off all blood supply to the inner tissue the manner described supra with respect to the embodiment sample.Allernatively, if desired, the cutting element 20 may besimultaneously rotated and moved axially, by moving the of FIG. 1, the cutting element 20a i charged with RFenergy s from a proximally disposed electrosurgical generator (not shaft 18 axially, in order to create a "CorkscreVY- shaped shown). Then, the cutting element 20a is radially extended tissue segment. . Once Ibis initial isolation step is completed, the cutting 25 by thcpractitioner, using a proximal control mechanism (not element or wire 20 is preferably further radially extended to show), ( 0 a Position as shown, for example, in FIG. 16. the position shown io FIG. 9. niSis accomplished by Once extended, the cutting element is moved axially in a sliding Ihe lever 36 proximally to another detent 60 10 proximal direction along the slot 66, a s illustrated by the arrow 68 and the phantom images of the cutting elemen1 further proximally retrad the sheath 30.Then, the third lever 40 may be axially slid distally to another stop or detent 52 30 2 0 ~ . order to isolate a generally cylindrical tissue in IO further radially extend the cutting wire 20. Once radially segment, as the cannula 1 8 is rotated about its axis 1% ~ positioned, the cutting elemenl 20 is energized by the simultaneously. FIG. 19 illustrates a p r w d u r e similar lo that illustrated in electrosurgical generator, after which the knob 34 is rotated lo rotate the culling elemenl 20 Uirougl~. 360 degree arc. 35 FIG. 18, except that while the culling element 20n is being a This rotational cutting action functions to complelely sever axially moved in a proximal direction as shown by arrows a second segment of the tissue sample from the surrounding 70, it is also deployed to various radial heights, in order lo tissue, thercby cutting off all blood supply to this scgment as create a 'variable height cut. well. Once segmentation of the tissue sample has been ' h e x steps may be repeated as many limes as desired, in 4o completed, whichever embodiment has been employed, order to ensure that the tissue sample is segmented for esch tissue segment can he withdrawn using a suitable ih efficient renioval from the patient's body. Ultimately, retrieval apparatus. Preferahly, the tissue segments are w t however, a final cut is preferably made, by fully retracting drawn through a cannula, such as the sheath 30, King such means a s a suction grasper, flexible mechanical graspers, an the outer sheath 30, using !he slide lever 36, and fully extending the cutting wire 20, using the slide lever 4 , So 45 auger conveyor, a prickly bristle or brush grasper, a wire 0 relrieval basket, or,the like. that the cutting element 20 extends radially beyond the periphery O f the large1 Itsion 54, illustrated in FIG. 10. The foregoing procedure .and apparalus may be used for The cutting element is then energi7d with R F energy, in the either a diagnostic or a therapeutic purpose. It is particularly advantageous for a diagnostic procedure because the resultsame manner as previously, after which the knob 34 is rotated to rotate the cutting wire 20 through a complete arc s,-, ant incision from the procedure will not substantially exceed in length the diameter of the cannula. On !he other hand, a about the axis.19.At this point, the entire lesion 54 should second preferred embodiment, illustrated in FIGS. 11-16, is be complctely isolated from surrounding 'tissue, with a particularly suiled IO a therapeutic procedure, wherein ii is sufficient margin about [he outer periphery thereof lo ensure successful removal of h e entire. lesion. highly desired to ensure that the entire lesion of interest is During the foregoing segmentation process, if the cutting 55 removed in one step, withoul segmenting that lesion within the body.This approach emphasizes maximum safety, in that element 20 remains charged by RF energy during the stepwise radial.extension process, the outer tissue rings will only a single procedure is necessary, assuming the tissue sample margins are clean, and thc incision necessary to -be further segmentcd radially. Other sgmentation apprvdches may be advanpageously remove the intact tissue sample is of the minimum Size than seg- 60 nc-ar)' 10 remove the sample. With this Procedure, there utilized as well, if desired. For example, ra~her menting the tissue sample circumferentiai]y, from the inside i also a somewhat reduced risk of cell migratioq rrom the s out, the tissue sample may be segmented circumferentially specimen 10 the surrounding lissue, since as described below, the specimen is encapsulated as soon as it is isolated from the oukide in, i.e. by making an Outer circumferential CUI (FIG. lo), then partially retracting the cutting element 20 and then Promptly removed. No segmentation of the sPe&and culling additional layers, as shown in FIGS. 8 and 9. 65 men occurs within the patient's body. , Referring now to FIGS. U-14,wherein like elements to Alternatively, tbe.ti&ue may be scclioned by extending and retracting the cutting element 20 radially, akin lo "sedioning those in the first embodiment are identified by like reference , NE0 02273 Case5:07-cv-05740-JF Document25-8 Filed06/24/08 Page18 of 20 US 6,331,166 B1 9 10 I . element 20a and encapsulation elements 72, to move ajtially numerals, followed by the letter "b", there is shown the a distance equivalent to that uaversed by the lever 40. Tbis, distal end or disposable wand portion 126 of an inslrument of course, results in the radial expansion of the cutting 106. The portion 12b includes a distal tip 146, which may be element 206 and encapsulation elements 72 to an arched or constructed in a manner similar lo that of tip 1 4 in FIG. 1, a shaft186, and a sleeve 306. Disposed in a radially retracted 5 bowed configuration-as shown in FIG. 14, wherein the cutting element 206 defines a peripheral boundary which lies orientation in a recess 48b of the shaft 186 are a plurality of radially beyond the peripheral boundary of the lesion, a in 5 encapsulation elements or bands 72, one of which a h the case of the first embodiment shown in FIG. 8. Again, it comprises a single electrosurgical cutting element 206. For should be noted that the cutting element and encapsulation the purposes of the invention it is unimportant which of the encapsulation elements 72 may be charged by means of RF 10 elements need not he fully extended, especially if an ellipsoidal or toroidal cutting geometry is desired, in which case energy to form an electrosurgical cutter, and in certain intermediate stop 61 is utilized. instances it may be advantageous to employ a plurality of cutting elements. Each of the encapsulation clements 72 and Once the nitting element 206 and associated encapsulathe cutting element 206 are attached at their distal ends to the tion elements 72 are radially expanded as de.wibed supra, it distal end of the shafl 186, at its connection wllh the distal 15 is time IO isolate the target lesion from surrounding h u e . tip 146 of the instrument lob, which connection is preferAdvantageously, a spherical or toroidal tissue sample having ably accomplished by means of a keyway 74. a radius of a1 least IS mm may be defined and isolated by rotating the cutting element.20b about the axis of the shaft The proximal end of the instrument 10b may be substan186. The encapsulation elements 72 will also be rotated tially the same as that for the instrument 10, illustrated in FIGS. 4-7, comprising a reusable driver portion having an 20 during this process, but their function is not yet impomnt. To complete the isolation step, the cutting element 20b is actuator for axially moving the sheath 30h between proximal energized by the electrosurgical generator (not shown), after and distal positions, a linear actuator for axially moving the whicb the h o b 34 i rolaied. either manually or via a s shaft 186, an actuator for rotationally moving the shaft 186, motorized drive mechanism, to rotate the shaft 186,and thus and an actuator for axially moving the proximal ends of the encapsulation elements 72 and cutting element 206, in order 25 the cutting element 206 through a 360 degree arc. This rotational cutting action functions to crompbtely sever the to radially extend and retract each of the elements 72 and tissue sample from the surrounding tissue, thereby cutting ZOb, as illustrated in FIGS. 14-16. off all blood supply to the tissue sample (and thus from the In operation, as with the first embodiment of FIG. 1,when lesion, which should be completely contained within the it is determined that either a diagnostic or therapeutic biopsy procedure is indicated, the distal disposable wand portion 30 tissue sample). After the isolation step is completed, the isolated tissue 12b of the instnment 10b will be moved axially to a position sample may be retrieved from the patient's body 56. This wherein the distal lip is adjacent to and distally of a target n retrieval step may be accomplished i a number of ways, but lesion, using the stereotactic rail 26 and associated imaging it is the objective in connection with the illuslrated embodisystem. During this process step, wherein gross linear movemcnt of the wand l2b is controlled by the rail systcm 26, the 35 ment to encapsulate and remove thc isolated tissue sample in one piece. Accordihgly, as is illustrated in FIGS. 15 and 16, electrosurgical cutting element (not shown) on the distal tip continued rotation 01 the shaft 186, once the isolation step 146 is energized to pierce and cut through the patient's body has been completed, preferably with the cutting element206 tissue to permit distal advancement of Ihe wand 126 lo the de-energizd, will twist and tighten the encapsulating eleregion surrounding the lesion. Once the distal tip 146 is generally in the desired position 40 ments 72 and the cutting element 206 about the tissue sample (not shown). As the shaft 186 is rotated, and the adjacent to the target lesion, Using the stereotactic rail 26, the encapsulating clcmcnts 72 radially retracled and wistcd, second lever 38 is actuated to provide fine tuning of the axial they will function to deform the tissue sample radially so position of the distal tip 146 relative to the lesion, by moving that it ismore compact and more securely retained within the the shaft 186 axially to a desired position, and securing the lever 38 in an appropriate stop 50 to maintain the desired 45 spaced defined by the encapsulating elements 72. Once the tissue sample has been fully encapsulated, the axial position. This fine axial adjustment of the axial movetissue sample may be removed from the patient's body. ment of the shaft 186is performed using appropriate imagAdvdnlagwusly, since the tissue sample is larger in mossing equipment. The objective 01 this p r o w s step is to ensure section than the cross-section of the sheath 306, the inventhat the distal end of the cutting wire 206 is disposed distally of the distal peripheral edge of the lesion, while at the same 50 tors have developed an inventive approach for removal thereof which results in minimum trauma and incision size time the proximal end of the cutting wire 206 is disposed for the patient while still permitting the removal of an intact proximally of the proximal peripheral edge of the lesion. specimen. To remove the specimen, the sheath 306 is This will cnsure the ability 10 isolate the entire lesion during retracted proximally, following which the cutting element the cutting procedure, with suficient margins to minimize the chance that any portion of the lesion in;idvertently 55 206 is again energized by the electrosurgical generator. The shafllsb, with the tisue specimen encapsulated thereabout, remains behind in llie patient's body following removal is then proximally withdrawn by the practitioner, with the thereof. cutting element 206 functioning to CUI through the tissue When the distal tip 146 is in the precise position desired necessary to create a passage for exit of the sample. Once the by the practitioner, first lever 36, which is normally disposed in a first detent 58 (FIGS. 5 and 6> in the first slot 42, is 60 unit, including the shaft and encapsulated tissue mass, is actuated proximally unlil it reslsin a second detent 60 (FIG. completely withdrawn from the body, the incision created by the cutting element206 upon withdrawal from the body may 7) in the first slot 42. This action retracts the sheath 306 he adhesively closed, with minimal required follow-up care proximally a su5cient distance to completely unwver the and scarring. cutting element 20b and associated encapsulation clements Many allernalive embodimenls may be used to accom72. The third lever 40 may then be actualed distally along the 65 plish the method outlind supra, which essentially involves third slot 46 to the distal-most stop 52, thereby causing the isolating he tissue mass from surrounding tissue, encapsurod 32, and therefore the proximal ends of the cutting NE0 02274 Case5:07-cv-05740-JF Document25-8 Filed06/24/08 Page19 of 20 US 6,331,166 B1 11 12 lating the tissue mass in place about a shaft, then removing figured to be manipulated to segment said tissue specimen the encapsulad tissue mass and shaft from the body by after it has been isolated from h e surrounding tissue. 13.The biopsy instru'ment as recited in claim 12, wherein energizing an RF eleclrosurgical cutler to cut its way out, without the need for a cannula or pre-existing incision. For the electrosurgical proximal lissue cutting element is conexample, a plurality of culling elemenls could be employed, .5 figured to segment the tissue specimen as il isbeing retracted or a separate cutting element could be disposed on the shaft. from said radially extended position to said radially retracted An impoflant aspect of the invention, of course, is a relapadion. tively high likelihood of acquiring the entire lesion of 14. The biopsy instrument as recited in claim 13,wherein said radially exlended position comprises a 6rsl radially interest i n a single therapeutic procedure, without the need ,o exlended pmsihn, and .wid eleclro.s~~rgical proximal tissue for follow-up surgery. cutting element is further actuatable to a plurality of addiWhile this invention has been described with.respect to various specific examples and embodiments, it is LO be tional radially extended positions, said eledrosurgical proxiundentoad that the invention is not limited thereto and that mal tissuc cutting element being rotatable about the longiit can be variously practiced within the scope of the followtudinal in eaCh of said radially extended positions to ing claims. ,5 selectively peripherally segment said lissue specimen. What is claimed i s 15. The biopsy instrument a s recited in claim 12, and 1 A biopsy instrument for isolating body tissue, compris. further a cannula having a lumen for providing ing: a passageway into the patient's body, the segments of said an elongate shaft having a longitudinal axis and a distal body specimenbeing removable from the u ) through said cannula. end, an electrosurgical tissue cutting element having a CUM16.A for isolating a tissue specimenin a palienl~s linear cutling surface secured to the distal end of-tbe body, shaB; and a) inserting into the patient's body a biopsy instrument for on a proximal tissue cutting, element disposed the elonisolating body tissue, comprising; gate shaft proximal of the distal tissue cutling element an elongate shaft having a longitudinal axis and a distal which is radially extendablefrom a radially revacted 25 end; position to a radially cxtended position, relative to the an electrosurgical tissue cutting element having a curlongitudinal axis, having an a r c u a b shape and being vilinear cutting surface secured to the distal end of movable in said radially exiended position and arcuate the Shaft; and shape to isolate a desircd tissuc specimen from sura proximal tissue cutting element disposed on the rounding ,issue by defining a peripheral abut 3o elongated shaft proximal of the distal tissue cutsaid tissue specimen. ting element which is radially extendable from a 2. The biopsy instrument as recited in claim 1,wherein the proximal tissue cutting element is rotatable about the lonradially retracted position to a radially extended position, relative lo the longitudinal axis, having gitudinal axis while in the radially extended position to an arcuate shape and being movable in said radiisolate said desired tissue specimen. 35 ally extended position and arcuate shape to isolate 3 The biopsy instrument as recitcd in claim 1,wherein the . a desired tissue specimen from surrounding tisue proximal lissue cutling element can bc actuated to cut tissuc by defining a peripheral margin about said tissue independent of the dislal tissue cutting elsmenl. specimen; 4. The biopsy instrument a s recited in claim 1,wherein h e electrosurgical distal tissue cutting element comprises a 40 b) advancing the biopsy instrument in the Patient's body until the distal end is disposed in a tissue region from monopolar electrode. which thc tissue spccimen is lo be isolated; 5 T h e biopsy instrument as recited in claim 1,wherein the proximal tissuc cutting clemcnt comprises an clccuosurgical c) energizing the proximal tissue cutting element with RF energy and radially extending said proximal tissue cutting elcmcnt. cutting element so that an arcuate pohon thereof is 6. The biopsy instrument a s recited in claim 5, wherein the 4s radially outwardly spaced from the longitudinal axis of electrosirgical proximal lissve culling element comprises a monopolar electrode. said sbaft; and 7.The biopsy instrument as recited in claim 5,wherein the d) rotating said proximal tissue cuUing element aboul the elecirosurgical proximal tissue cutting element comprises a longitudinal axis to.cut said tissue and create a periphcral boundary about said tissue specimcn, to isolate the so bipolar electrode. 8. Thc biopsy instrumcnl as rccitcd in claim 7, whcrein a tissue specimen from surrounding tissue in the tissue porlion of said shaft cumprims a return electrode of lhe region. 17. The method a s recited in daim 16, and further bipolar inst N ment . comprising segmenting said tissue specimen. Y.7he hiopsy instrument as recited in claim 1, and further comprising a sheath which is axially movable between distal 5s 18. The method a s recited in claim 17, and further and proximal positions for selectively covering and uncovcomprising withdrawing each segment of said lissue speciering Ihc proximal tissue cutting clcmenl. men through a cannula lumen. 19.The method as recited in claim 17, wherein segmenl10. The biopsy instrument as recited in claim Y, and ing said tissue specimen includes radially retrading said hrlher comprising a proximal driver unit for cuntrolling radial expansion and relraclion of the proximal tissue culling 60 proximal lissue cutting element so that the tissue specimen element and rotation of the proximal t i s u e cutting element is segmented radially. 20. The method as recited in claim 17, wherein segment-. about the longitudinal axis. 11;The biopsy instrument as recited in claim 10, wherein ing said tissue specimen includes partially radially retracting the proximal driver unit further controls axial movement of said proximal tissue culling element from ils fully radially 6s expanded position and rotating the instrumenl about the said shafr and axial movement of said sheath. 12. The biopsy inslrumenl a s recited in claim 5, wherein longiludinal axis to cut said tissue and create a circumferential lissue segment. the electrosurgical proximal tissue cutting element is con' . ' NE0 02275 Case5:07-cv-05740-JF Document25-8 .. Filed06/24/08 Page20 of 20 13 US 6,331,166 B1 14 .. from a radially retracted position to a radially extended position, relative Io lhe longiludinal axis, and being movable in said radially extended position plurality of circumferential tissue segments are created. to isolate a desired t i s u e specimen from surrounding 22. The method as recited in claim 16, and further 5 tissue by defining a peripheral margin a h 1 said comprising simultaneously moving the proximal tissue cuttissue specimen; ting element axially as it is rotated about said longitudinal b) advancing the biopsy instrument in the patient's body axis to cut said tissue. until the distal end is disposed in a tissue region from 23. The method of claim 16 further comprising retrieving is lo be which Ihe tissue the tissue specimen from the patient's body after il has been i o c) energizing the proximal lissue cutting elcmcnt witb RF isolated. energy and radially exlending said proximal tissue 24. A biopsy instrument for isolating hody tissue, comcutting element so that an arcuate ponion thereof is prising: radially outwardly spaced from the longitudinal axis of an elongate shafi having a longitudinal axis and a distal IS said shafl; and end, d) rotating said proximal tissue Culling element a b U l the a distal 1-e cutting element having a linear cutting longitudinal axis to cut said tissue and create a periphsurface disposed on the distal end of the shaH; and era1 boundary about said tissue specimen, to isolate the an electrosurgical proximal tissue cutting clement d k tissue specimen from surrounding tissue in the tisue posed on the elongate shaft proximal of the distal tissue cutting element which is radially extendable 2o region. from a radially retracted position to a radially 28. The method as recited in claim 27, and further extended position, relative to the longitudinal axis, comprising segmenting said tissue specimen. having an arcuate shape and being movable in said 29. The method as recited in claim 28, and further radially extended position and arcuate shape IO isocomprising withdrawing each segment of said tissue speci. late a desired l k u e specimen from surrounding 25 men hrough a cannula lumen, tissue by defining a peripheral ma@ about said 30. The method as recited in claim 28, wherein segmenttissue specimen. ing said tissue specimen includes radially retrading said 2 5 The biopsy instrument as recited in claim 24, wherein eledrosurgical proximal tissue cutting element so that the the electrosurgical pmximal tissue cutting elemenl can be 3o lissue specimen is segmented radially. actuated IO CUI tissue independent of the distal tissue culling 31. The method as recited in claim 28, wherein segmentelement. ing said tissue specimen incIudes partially radially retracting 26. The biopsy instrument as recited in claim 24,wherein said electrosurgical proximal tissue cutting element from its the electrosurgkal proximal tissue cutting element cornfully radially expanded position and rotating the instrument prises a monopolar elecuode. a b u t the longitudinal axis cut said tissue and create a 27.A method for isolating a tissue specimen in a patient's J5 circumferential tissue segment. hody, comprising: 32. The method a s recited in claim 31, wherein segmenting is repeated at differing partially radially expanded posia) inserting into the patient's body a biopsy instrument for tions of the electrosurgical proximal tissue cutting element, isolating body tissue, comprising: an elongate shaft having a longitudinal axis and a distal 4o so that a plurality of circumferential tissue segments are cnd; crealed. a distal tissue cutting element having a curvilinear 33. l'he method a s recited in claim 27, and further comprising simultaneously moving the proximal tissue CUIcutting sitrhcz disposed on the dislal end of the ting element axially as it is rotated about said longitudinal shaft; and an electrosurgical proximal tissue cutting element d k - 41 axis to cut said tissue. posed on the elongate shaft proximal of the distal a***+ h u e cutling element which is radially extendable 2 .The method as recited in claim 20, wherein segment1 ing is repeated at differing partially radially expanded posilions of the proximal tissue cutting element, so that a NE0 02276

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