Mou v. City of San Jose et al

Filing 1347

Mou v. City of San Jose et al

Doc. 1347 Att. 2

Case5:07-cv-05740-JF Document25-3

Filed06/24/08 Page1 of 23

United States Patent
Lee et at;
METHODS

119)

1111 Patent Number:
14s)

6,022,362
Feb. 8 , 2 0 0

Date of Patent:

1541 EXClSlONAL BIOPSY DEVICES AND
1751 Inventors: Robem.L e Ratwood City; James e, Verier. Portola ViUey. bo& of Calil.

W .

Primary Examiner4blid;ael Buiz A d l a m E x a m i n e r 4 e v i n Truong Anornq, Agent, or Firm-Young Law Firm,

PC ..

1571

AEsSTFacr

[73] Asigncc: Rubicor Medical, Ic. Redwood City. n.

Calif.

121I [22]

Appl. No.: 09/146,743 Filed

Sep. 3, 1998

An exckional biopsy device iocludes a tubular member having a window near a dislal.tip tkrwf; a cutting twl. a distal end of Ihc cutting twl bring attached ncar the dish1 tip orlhciubuldr member. at least a.distal purlion ortht: culling tool being configured to selectively bow out of the window and 10 retract within the window; aod a tissue collection

.

[SI] Int..Cl? . . A61B.17/22 1521 U S . CI. -_._.._.__._I._ 6061159; 606/170; 600!564 [SS] Field of Search _._.____._._._.I_ 606!159. 170. 606/171,167.180; 600/564.565.566,-

567; !28/898

.is61
3,732,S8 4,903,696 4;%6,604 5,152,293 5,217,479

References Cited
U.S. PATENT DOCUMENTS

5!1973 Rdnko 6M;jM m990 aim ci ai. . 1011990 R c i i . 1011992 Vonab c l al. . 611993 Suler __._..I.___.______. 6061180 5,224,488 711993 Ncuffcr. 5.224945 711993 Pannck ti a]. 5,441,SlO 8Il995 Simpron ct aL 5,554,163 9n9% S l u r m a n . 5,630,426 511997 Eggcn d a 1 .
~

-

device externally aitacbed at least to the tubular member, tbc tissue colledon device collecMg lirmc excised by the cutting- tool as Ibe biopsy device is rotated and the cutting tool is bowed. A0 excisional biopsy meihcd for soft tissue includes tbe steps of insening a generally tubular member into the k u e . the tubular membcr including a cutting tool adaptcd to selectively bow away from the tubular member and an external tissue collection device near a distal tip of the tuhular mernher; rotating the tuhular member. selectively f varying a dcgrec of bowing o the cutting tool; collecting tissue severed by the cutting loo1 in the tissue collection device; and retracting the tubular member from the soft tissue. The lubular memtxr may include an imaging transducer and I method may include the step of displaying k information received &om h e t r a d u c e r on a display device and Ihc step of varying the degree of bowing of the cutting tool based upon tbe displayed information from tbe imaging uam3uce.r. Alternatively, h c imaging transducer may be dkpcsed w t i a removable transducer core adapted i fit ibn o within the tubular member.

.

5.895393

5.672Jl2

9,1997 Zupkas.

411933 Earbuc c i al.

6W:tS9

22 Claims, 10 Drawing Sheets

NE0 02120

Dockets.Justia.com

Case5:07-cv-05740-JF Document25-3

Filed06/24/08 Page2 of 23

_U.S. Patent
6,022,362

Feb- 8,2000

Sheet 1 of 10

f l o 5 1 2 5I

121 .

-------

I
I

c ,
110
1.

130

270

FIG. 1 A
125

-------

Y

,115
i

I

110

FIG. 1 8

120

FIG. 1C

NE0 02121

Case5:07-cv-05740-JF Document25-3

Filed06/24/08 Page3 of 23

.-

U.S. Patent

Feb. 8 , 2 0 0

Sheet 2 of 10

6,022,362

260

270

110

FIG. 2B
215

2; 2

7-

225

FIG. 2C

i

NE0 02122

Case5:07-cv-05740-JF Document25-3

Filed06/24/08 Page4 of 23

U.S. Patent

Feb. 8,2000

Sheet 3 of 10

6,022,362

NE0 02123

Case5:07-cv-05740-JF Document25-3

Filed06/24/08 Page5 of 23

U.S. Patent

Feh. 8,200

Sheet 4 of 10

6,022,362

FIG. 4

i

120

FIG. 5

126

FIG.. 7

N E 0 02124

Case5:07-cv-05740-JF Document25-3

Filed06/24/08 Page6 of 23

_-

U.S. Patent

Feh. 8,2000

Sheet 5 of 10

6,022,362

120

1

FIG. 8

I

FIG. 9

NE0 02125

Case5:07-cv-05740-JF Document25-3

Filed06/24/08 Page7 of 23

..

U.S. Patent

Feh. 8,2000

Sheet 6 of 10

6,022,362

L

0
T

-

0

cu-

LL

6

/ z
0

% '

0

r-

7

0

%

NE0 02126

Case5:07-cv-05740-JF Document25-3

Filed06/24/08 Page8 of 23

U.S. Patent

Feb. 8,2000

Sheet 7 of 10

6,022,362

NE0 02127

Case5:07-cv-05740-JF Document25-3

Filed06/24/08 Page9 of 23

U.S. Patent

Feb. 8,2000

Sheet 8 of 10

6,022,362

0

N

0)

NE0 02128

.. Case5:07-cv-05740-JF Document25-3

Filed06/24/08 Page10 of 23

U.S. Patent

'Feb.8,2000

Sheet 9 of 10

6,022,362

,550,

126

126

540 7 I

530

FIG. 15

560
540 7

560

125

I

FIG. 16

NE0 02129

Case5:07-cv-05740-JF Document25-3

Filed06/24/08 Page11 of 23

U.S. Patent

Feb. 8,2000

Sheet 10 of 10

6,022,362

( )
$.
S I
INSERT CUrCEWUS CORE ASSY THROUGH SHEATH, ADVANCE ASSY PAST END OF SHEATH ADJACENT TO TARGET LESION RECONFIRM CORRECT POSITION AND ROTATIONAL ORIENTATION USING SURFACE US AND/OR CORE US GROSSLY TARGET LESION

I

,

SI: AFTER CUTTING COMPLETE, REMOVE CORE/

J

t

s2

STABILIZE BREAST

REINSERT US CORE THROUGH SHEATH TO VERIFY COMPLETE EXCISION OF LESION

-

SITE, ANAESTHETIZE & MAKE SMALL INCISION
r

t

s 9

54

INSERT US CORU SHEATH ASSY ADJACENT TO TARGET LESION UNDER SURFACE US GUIDANCE

ACTIVATE ANAESTHETIC INFUSION
I

t

s5

REMOVE US CORE, LEAVING SHEATH IN PLACE WITHIN BREAST

SI 0 EXTEND CUlTlNG TOOL WHILE ROTATING AND VISUALIZING USING CORE US
s11 CUT AND EXTEND/ RETRACT CUmNG TOOL AS NECESSARY WHILE ROTATINGAND BAGGING

t

+

LOCK US CORE INTO CUTTER ASSY
I

I I
I

I-

FIG. 17

NE0 02130

Case5:07-cv-05740-JF Document25-3

Filed06/24/08 Page12 of 23

1
EXCISIONALBIOPSY DEVICFS AND
.

2

.

'

Another conventional technique l o c a l i i the suspicious lesion using stemtactic digital mammography. ihc patient METHODS i s placed prone on a special table that includes a hole to BACKGROUND OF THE INVFNTION allow thr. designated breast to dam& Levthruugh. Thhc 5 breasl i compressed between two mammography plates. z 1. Field of the Invention which stabilizes h e breast to be biopsicd and allows tbc .. h e present invention pertains to the field of soft tissue digital mammograms to be taken. A lea? two images are L excisionat hinpsy deviccs and methods. In particular, the taken 3Udegrces apan to obtain slereoIacticviews.lhc x, y present invention relates lo the field of devices and methods and z coordinates iargeliog the lesion are calculated by a C r excising suspicious lesions from soft tissue. such as In computer. 1 % ~ o physician then aligns a special mechanical breast tissue. stage mounted under the table that p l a a s the biopsy device 2. Lkscription of the Related Art into the breast to obtain the sample or samplls. There are I believed O be three methods available to biopsy lesions Breast ranczr i a major threat and &ncern to women. s using a stereotactic table: (1) fine needle aspiration, (2)core Early detection and treatment of suspicious or cancerous lesions in the breast bas been shown to improve long term " nccdle biopsy and (3) vacuum-ass-ktcd mrc ne& biopsy. Fine needle aspiration uses a small gauge o c d c , usually I I is, I survival of the patient. Tbe ICK therefore. to encourage 20 to 25 gauge, to aspirate a small sample of cell.. from the women 001 only to perform monthly self-breast examination s lesion or suspicious area. The sample i smeared onto slidcs and obtain a yearly breast examination by a qualified that are stained and examined hy a cyropathologiu. In this physician. but also to u d r g o annual weening mammogtechnique. individual wlls in the smears are examined. and raphy commencing at age 40.Mammography is the only 21) lissue .architccturc or hislology is generally not preserved. screening modality available today that can detecl small. Fine needle aspiration is a b very dependent upon the skill noopalpable lesions.These noopalpable lcsions may appear and experiena of the operator and can result in a high as opaque densities relative to normal breast parenchyma nonaiagnmtic rate (up to about 83%). due to inadequate and fat or as cl\rrters of microcalcibcations. sample collectionor preparation. m e conventional method for diagnosing. localizing and ZJ Core needle biopsy uses a larger size needle. usually 14 excising nonpalpable lesiom detected by mammography gauge tosamplc the lesion. T i u e architecture and histology generally involves a timesoosuming, multi-step proozss. are preserved with lhis method. A side-cutting devia. conFirs, the patient goes to the radiology depanment where the sisting of an inner trough with an outer cutting cannula is ,attached lo a spring-loaded device for a rapid semiradiologist finds and localins B e lesion either using mammography or ultrasound guidancz. O m localized, a radio- 3o automated firing action. After the lesion is localized. local anaesthetic is inwilled and a small incision is made in the s & opaque wire i inserted into the breast. ' distal end of the skin with a scalpel.The device enters &e breast and the wire may include a small hook or loop. Ideally. this is placed needle tip is guided into the breast up.to the largcted lesion. adjacent to the suspicious area t 0 . k biopsied. The patient is The dcvia. is fired. Fat. the inner cannula mmtaining ihbc &en transported to t k operating room. Under general or 35 trough rapidly penetrates thF I+on. Immediately following local anesthesia. the surgeon performs a prooedure called a this. the outer cutting cannula rapidly a d v a n w over the needle-localized breast biopsy. In the needle-localized breast h e r cannula cutting a sample,of tissue off in the trough. biopsy. the surgwn. guided by the wire previously placed in The whole device is then removed and the sample retrieved. the patient's breast, e x c k a mass of tissue around the distal f s end o the wire. The specimen i sent to the radiology Multiple penetrations of the core needle through the breast department where a specimen radiograph is taken to confirm and into the .lesion are required IO obtain an adlquate sampling of the lesion. Over 10 samples have been recomthat the suspicious lesion is contained within the excised mecded by some. specimen Meanwbile. the surgeon, patient. anesthesiologist and operating room stas, wait in the operating room for The vacuum-misted breast biopsy system is a larger confirmation of that fact from the radiologist before the s semi-automated side-curting.device. It i usually 11 gauge in s operation i completed. The suspicious lesion should ideally diameter and is more .sophisticated than thr core needle b e excised in toto with a small margin or rim of normal biopsy device. Multiple large samples can be obtained from breast h u e on all sides. Obtaining good margins of normal the lesion without having to re&ert the needle each time. A lissue is extremely dependent upon the skill and experience vacuum is added to suck the tissue into thc trough. The rapid of the surgeon, and often M excessively large amount of firing action of the spring-loaded coremeedle device i s nonnal breast tissue is removed to ensure that the lesion is 50 replarrd with a0 w ~ l l a t i n outer cannula that cuts the breast g located within the specimen. This increases the risk of tissue OZin Ihe trough. ' % l physician controls I& speed at pos-operative complications. including bleeding and perwbicb tk outer cannula advances over the trough and can manent breast deformity. As 80% or h a s t biopsies inlay rotate the alignment of the trough in a clnckwisc fashion to are benign, mdny women Unoeassanly suKer from permaobtain multiple samples nent scarring and deformity'from such benign breast biop- 55 I C a fine necdle aspirate, needle core biopsy or vacuumsies assisted biopsy shows malignancy or a spccibc benign diagnosis oC atypical hyperplasia. i h n the patient needs to More remntly, l a invasive tecbniqua have been dcvclundergo another procedure. the traditional needle-lwalized oped tu samplc or biopsy t suspicious lcsioos to obtain a h histological diagnosis.'Ihe simplest of the newer techniques breast biopsy, IO fullv excise the area with an adeauate ._ is to attempt visualization of the lesion hy external ultra- M) margin of nonnal breast t k u e . Sometimes h e vacuumassisled device removes the whole largered lesion. I f this sound. If seen by external ultrasound. the Iesion can be orma. a small titanium clip should be placed in the biopsy biopsied while being continuously visualized. This techfield. This clip marks the area if a needle-localized breast nique allows tliphysiciao to see the biopsy needle as it actually enten the lesion, thus ensuring that thc mrrw area biopsy is subsequently required for the previously menis sampled. Current sampling systems for use with external 6s tioned masom. ultrasound guidance include a fine netdle aspirate. core Another method of biopsying the suspicious lesion utineedle biopsy or vacuum-assisted biopsy devices. lizes a large endcutting core device measuring 0.5 cm to 2.0

.

Case5:07-cv-05740-JF Document25-3

Filed06/24/08 Page13 of 23

6,022,362 3
cm kdiameter. lhis also uses the stereotactic table for

4

with the same inherent awkwardness for the patienl. as stabilization and localization. After the lesion cnnrdinatcs discussed abnvc. Bleeding is controlled, albeif manually, f requiring that the patient wait until the end o the prncedure are calculated and local anesthesia instillcd. an incision large s enough i permit entry of the bore is made at the entry site to he turned ovcr. Compression i used lo aabilize the breast s with a scalpel. The breast tissue is mred down to and past 5 aod localize the lesioos Tbc breast. however, may be the lesion. Once the specimen is reuieved. the patient is torqued and distorted belwccn the compression plates such ,turmA onlu her back and thc surgeon cautcrixs blwding that when the plates arc removul aft= the biopsy. the largc vrssrls u d e r dimxi-vision. 7hc incision, measuring 0.5 to corc track Icft behind may nul bc straight. but adually larger-than 2.0 cm is sutured closed. tortuous. This can result in permanent hreasl deformity. She srcrcolactic table requires awkward positioningof the in The location of the insertion site into \he breast is dictated patient and may be extremely uncomfortable. The woman by lhe positioning of the breast in the machine and mt by the r w lie prone during the entire procedure. which may be n physician. T l e entry site is usually away from the nippleh p s s i b l e f r some patienk. In addition. thc lesion to be o s areolar wmplex and i usually localcd.oa the more ex@ f biopsid must be in tbc cznter working area o the mamareas u l he breast. Fur Be 6oc n c d k aspirac. cure biopsy mography plates. W i s may be extremely difficult and 1s and vacuum-asskted d e v i c y the iocision is usually very unmmfonable for the patient if the lesion is very posterior small and the scar almosf unapprcciable. However, in tbe near the chest wall or high towards &e axilla. case of the large mre hinpsy device (0-5 In 2.0 cm).a large incision is needed. Such a large in+ion ofien resulis in a She woman is subjected to increased radiation exposure non-aesthetically placed scar. as multiple radiographs are required throughout the coum X I UP the p d u r e to:.(l) cunfirm that the Icsion is within Be Tlx ncwcr cunventional minhally invasivc breast biopsy working area of the mammography plates. (2) obtain Ihe I devices have improved in some ways Ihr. ability O diagoosc stereotactic coordinates (at least IWO views), (3) verify the mammographically dele& nonpalpable lesions. Tlhew: . positioning of the biopsy necdle prior to obtaining tissue, devices give the patient. a choice as lo how she wants the and (4) verify that the lesion was indeed sampled. If any diagnosis to be made. Moreover, lhesc devices are substan25 difficulty is encountered during the procedure. additional tially lcss expensive than &e older tradifional nccdle.radiographic exposures are rquired to vm-fy correction of localized breast biopsy. 'Ihcy are nof. however, the final the problem. solution. Due IO the above-dimtsscd problems and risks associated with compression, nadle-track seeding, blood Using the core needle biopsy or vacuum-assisted devicc, bleeding is controlled only by manual pressure. Bleeding is 30 bornr rnctaslaxs, bleeding. radialion cxposure and awkwardness of the stereotactic table, more refined devices and generally not an issue with fine needle aspiration, but is a methods are needed to resolve these i s u s . Also. the conlegitimate ,complication of the formcr two methods. ventional biopsy devices do not cnnsider margins in their Ecchymases. breas! edema and hematomas can occur. This excisions and if cancer is diagnosed, the patient mu1 causes increased post-procedural pain and delays healing. Rarely, he patient may require an emergency operation to 35 undergo a needle-localized b r e a lumpectomy lo c e r e that adequate margins are removed around the cancer. Devices control and evacuate a tense hematoma. and methods. therefore. must address the problem of obtaioAnother major mncern is the possibility o f tumor dising adequate margins 50 that a sccond procedure is 001 semination. The mre needle biopsy and vacuum-arsisted required. Margins, moreover, cannot be assessed while the devices both cut into the tumor and carve out multiple samplcs for examination. While cutting into the tumor, a breast is heing compressed. canccruus e l l s may bc dislodged. Culling ac'ros blood SUMMARY O F I H E INVWI'ION vc.sxls at the samc time may allow thc frccd caIIccrous ~ 1 1 s I! is. therefore. an ohject of the present invention to a w e s Io t blood stream. thus possibly sccding thc tumor k provide devices and methods to efficiently and safely excise beyond its original locus. The long-term c o q u e n c e s of rm Iumor seeding with the risk of bloodlmrne metastases arc OS suspicious lesions f o the breast. It is also an object of the present invention to provide devices and methods that unknown at this time, as Be techniques are relatively new. remove the entire lesiohintact with the minimum amount of However, documented instances of cancerow CCUS seeding normal tiuue surrounding the IcSiw' needed IO provide locdly into needle tradcs exis. There are numerous repons adequate margins It is a further object of the present of meustases growing in needle tracks from previous b i o p invention to provide devices and methods that orovide siesof a canOtrous m a s . Moa ofthrsc arc fiom lungor liver IO : hemostasis in the b r a t t minimize complications OP o cancers. However, at least one case of mucinous carcinoma ecchymosis. hematoma formation, and breast edema. It is of Be breast growing in a needle m c k has been reported. another object of Ihe present invention to provide methods The long-term cnnsequenccs of neoplasm .seeding into and devices to provide intra-tissue ultrasonic guidance to needle tracks are currently unknown, again hecause the techniques are relatively new. =me recnmmend excision of ss provide real time. insilu monitoringof the procedure. Astill further object is to provide devices and methods that allow the entire needle tra& including the skin entry site. during thc physician to.minimize the sizc of the incision though the definitive surgical procedure for a diagnosed cancer, s which thc procedure i performed and to leave an aesthetiwhether it be a l u m p t o m y o r a mastectomy. Otkea assumc cally acceptable .scar on the breast. . . that witti a lumpeuomy. the part-uperativc radiation therapy will destroy any d i s p l a d cancer cells in the needle ta . 6o lo accordance with the abovedcsaibed objects and thosc rs that will be menlioned and will become apparent below. an With the trend towards treating very small cancers only by embodiment of an cxcisional b i o p y device acmrding to he excision and without a pos-extision course of radiation prcsenl invention comprkex therapy. the risk of cancer cells metastasizing and growing in needle track is v u y real. a tubular member having a window near a distal tip thereof; ?he large core cutting devicr (0.5 Em to 2.0cm) gemrally 65 a cutting tool, a diial end of the cutting tool being eliminates the risk of needle rrack xeding as it is designed attached near the distal tip of the tubular nienmber. at to excise the lesion intact. A stereotactic table is required

NE0 02132

Case5:07-cv-05740-JF Document25-3

Filed06/24/08 Page14 of 23

6,022,362
least a distal portion of the cuning tool being configdevice. a bwingcutting device. an electrosurgical device, a laser device and a vibrating device. The ultrasonic transured toseleaively bow out of thewindow and to retract within the window, and ducer may be-conneaed to at least one data p'omsing and aiiSUc coUcction & v i a externally attached at least 10the display device to allow an operatorof the device to a.scemin tubular member. the tissue collwtiun & v i e being 5 a structure of the I k U C and 10 control the operation of thc a tissucsamplcscvucdby the cutting work element before the tissue comes into contact with the adapted tu work clement as the device rolalcs. The work clcmmt may ml as l biopsy dtuj,.. k and the comprisc a cutling IOU!. a distal end ufthc cutting tool k i n g i howed. s atlached near the dimal tip of the tubular member. a1 least a According to funher emWimcnL\ the dicta1 p,-,rti,-,n of the Cutthg tool may comprise a thin ribbon s b q n e d on a In distal portion of the Lutling tool being configured to selecleading edge thereof. The leading cdgc of the thin &bon lively how out of a window in the tubular member and 10 may be serrated. The tubular member may comprise an retract within the window. The controlling meam may include means for selectively bowing and relraaing the internal guide allowing a proximal portion of the Lulling 1001 to slidc therein when a proximal end of the cutting tool is cutting tool. pushed in a distal direction or pulled in a pro-al djcli,,,j. IS Amording to yet another embodiment. an excisional Pr-ol biopsy method for soft t h e . according 10 I b e cutting 1001 may funher comprisean interior lumeo; and a pluralily of through bolesin the distal portion thereof. the invenlioo. c o m p r k Ihe S k p s Of: inserting a generally tubular membcr inlo the tissue. the through holes being in fluid communication with the interior tubular member iocluding a cutting tool adapted to lumen. The t h e coUection device may comprise a bag within whicb the excked sample of t k n e is collected. hn 20 selectively bow away f o the Nbular member and an rm external tissue colledon device near a distal lip of tbe opening of the bag may-be at least co-extensive with the tubular member; window i n the tubular member. The lissue collection device s may bewnfigured tu open and 10 close a the cutting tool is rotating the tubular member. ~ l ~ l i v e lbowed and reuaCted, EspectivelY. The tissue Y selectively varying a degree of bowingof the cutting r o d ; collection device may comprise a bag attached LO the tubular 25 tool in co~~ecling severed by the tissue member and to a trailing edge of the distal podion of the collection device; and the bag 'peeing and closingas the Nttiog lkUc. the tubular member from the and res~ctivelY.An seOSOr The mhtingskp may be carried out by manually rotating may bC wilbin Ibe &Ia1 portion Or Ihe tubular !hc tubular netubular member may funha biog Ihe ulrrasouod he include an imaging transducer a d t h e method may funber member as lo image lo cut by the include steps of displaying information received from culting tool a s the biopsy device is rotated. I b e ultrasound the transducer on a display varying of sensor may be electrically coweded to at one or more data bowing or based upon the displayed inforprocessing and display devices to allow either a real time or mation from imaging uaosducer. The may a near real lime graphical representation of the tissue to he .Is comprisi: an etclrosurgi~l blade ad th msy cut. The portion Of Ihe may be'elearicany further comprise step of varying the p,,wer(for example, Io RF Or an power pnion KF power) applied 10 eleclraurgial blade based upon or Ihe cutting Iwl may comprise a thin wire. infmmation received from the transducer. A n e p of stabiA0 invasive inlerventiooal dwice for soft biological 4o lizing soft tissue in an unaDmpressed 51ate prior'ro the tissue. according 10 a further embwJiment of the present inserting may also be carrid A of invention. comprises the cutting tool to assume a oon-cxtended state may be a roiatabk tubular member having a distal tip adapted to carried lo k n h gstep and &fore K.Uacpenetrate the tissue; lion stcp. The tissuc d e c t i o n device assumm a c l d a work element dkposed near the distal lip of the tubular 45 configuration when the cutting tool assumes the nonmember, the work element acting up011 the tissue extended state. l h e extension of the cutting tool may be coming into cootact therewith as tbe tubular member controUed by selectively and manually pushing and retraarolateq ing a proximal end of the cutting tool in the distal and Proximal directions. respeaively. The Cutting tool may an ultrasound transducer dispased near the distal tip of the tubular member and away from Ihr: work element, su 5o comprise an interior IUmCn and a.pturality of ihrougb boles that the tramdudcr sweeps a plane within thc &UC in fluid mmmunicalion Ihcrewith. and tbe melhod may h further comprisc lbe step of delivering at least one fluid to a k a d of &e work element a s t tubular member the tissue via the plurality of through holes. rotala; and ne present invention may also be as an meam for mntrolbng an operation of the work element born ullrasound 55 and treatment method for-soft tissue, comprising the steps he based upoo informarion traosduccr. of.. inserlinga tubular member into the soft t&ue.the tubular Awarding to SliU furlher cmWimcn&, the member iocluding an uluasonic transducer mounted lrarrwluccr may be tun& within a range fmm about 7.5 MHL near a distal end of the tubular member; to ahout 20 MHz. :Ihe ultra.sound t r a d u c e r may k disrelating Ihe mbdar member within the soft tissue; pnsedwithin the tuhular memher at an angle n relative to the 68 displaying an output of the ultrasnnic transducer on a work element. the angle a being no smalkr than that display device; and necessary to effectively control the operation oL the work acting upon the soft tissue based upon the displayed n element i response to the information gathered from the oulpul. transducer as the tubular membcr rotat- The angle u is preferably lcss than about I80 depres. Thc work element 65 According to hrthtx preferred emtwdimen&, the ullrasonic transducer may be tuned to within a frequency range may c m r s at leas.one d e v k selected from the group opie ofbetween about 7 5 MHz lo aboui 20 MHz. l b e acting step consisting of: an abrasive device. a reciprocating cutting
'

5

6

.

'

.

,

NE0 02133

Case5:07-cv-05740-JF Document25-3

Filed06/24/08 Page15 of 23

6,022362

7

.

may include a a e p of severing a selectively variable volume a single use disposable tisue collection device externally of .soft li.%uc from a main tkwe m a s . A slep of cnllecting attached at kast to the tuhular member, the tissue the severed volume of t i s u e in a tissue collection device mlleclion device collecting tissue severed by the cutmounted externally to thc iuhular member may also be ting tool as the biopsy device is rotated and the cutting carried out. 5 toolisbowed. According t a furthcr embodiment, an excisional biopsy o In yet another embodiment, the present invention is an devi=. according to the p m n t invention. wmpriwrr cxcisional biopsy dcvicz, wmprising: a Nbular member having a first and a wmndwindow near it a single use disposable tubular member having a fa and a distal tip thcreof; a semnd window near a distal tip hereof, the tubular 10 member including a cutting tool urnfigured to sclcca cutting tool configured to selectively bow out of the first lively bow out of the firsl window and to retrad within window and to retract within the fim window; and the f i s t window; and a removable transducer core. b e transducer core iocluda removable t r a d u w r wrc. the transducer curc including an active transducer element configured to face out ing an active transducer element configural to face out of the scfond window when the removable t r a d u c e r of the second window when the removable transducer core is fitted within the tubular member. awe is fitted within the tubular member. The removable core may be adapted to snap fit within the tubular member. The active transducer element may, for BRIEF DESCRlPTlON OF THE DRAWMGS eliample. indude an ul~rasoundtranduccr. The removable Fur a further understanding of the objerts and advantages transducer m e may indudc a tapered d S a l tip configured of the presznt invention, reference should he made to the IO readily penetrate soh tissue. A0 external tissue collcdion following detailed description, taken in conjunction with the d e v i a may be attached to the cuuing tool and/or to thc accompanying figures in whichtubular member. The tubular member may further comprise FIG. 1A shows an embodiment of the excisional device a r e w s c d section adjacent a trailing edge of the cutting tool, acwrding to the present invention with the cutting ton1 in iLr the recessed section being adapted to receive the external tissue collectioo device. An expandable sheath may also be zs flat. retraned configuration. includcd. the expandable sheath King a d a p t d to rweivo the F G 1B shows the excisional device of FIG.1 A with it.. I. removable transduer wrc and the tubular membcr. cutting tool in an extended, bowed configuration. I h e present invention may also be viewed ds a method of FIG. IC shows another view of the excisioml device of excising a lesion h m soft biological t h e using an exci- 3o FIG. 1A. sional biopsy system including a generally tubular member FIG. 2A depicts the distal region of another embodiment having a cutting tool. a removable transducer core adapted o the excisional device according to the present invention, f to fit within the Nbular member and an expandable sheath. showing the excisional device togetkr Hiith the external comptisiig the steps of: tisue cnllection attached thereto in the open configuration. fitting the transducer mre through the expandable sheath. JS FIG.2B shows the excisional device of F G 2A together I. inxrting the transduccr and sheath thuugh an incision in with the external tissue collcclion attached thereto in the h e tissue; . closed configuration. imaging a target site within thc tissue by e n e r g i h g thc FIG. 2C shows an embodiment o the proximal ngion of f transdurrr cure. the ex~isionil device according to the present invention. removing the transducer core from sheath while leaving FIG. 3A depiL- the operation of an embodiment of the thc sheath in place within the tissue; exckional device and method according to the present invention. securing the core within h e generally tubular member 50 the core faces outwardly from the tubular mcmber; FIG. 3 B further shows the operation of an embedment of the excisional device and method according to the.present slidingthe tubular member through theexpandablesheath until the cutting tool is positioned adjacent h e lesion; 4' invention. FIG. 3C further depica the operation of an embodiment cutting the lesion with the cutting tool; and of the excisional device and method according to the preseot -retracting at least the tubular member from the incision. invention. Astep o f stabilizing the hreast in one of an unmmprewd FIG. 4 shows a detailed view of a cutting tool sui@blefor and a slightly expanded stale prior to the insening slep may so use with the excisional device accordiig to the-pnscnt also be carried out. The sheath may remain withi the tisue invention aher the retracting step and the method may hmher a m FIG. 5 s h o w a. CIOSS section of he cutting tool. taken prise the step of re-inserting the traosrlucer core w i t h i the I. along line AA'in F G 4. sheath and imaging the target site to insure h a t the lesion FIG. 6 shows a detailed view of another cutting tool has been excixd. A step of collecting the cut lesion within 55 suitable for \rse,with the excisional device acoording to the an external tisue collection device secured lo the tubular present invention. member may also be carried out. Both the tubular member and the sheath may be reuacted from the incision. FIG. 7 shows a r ~ o ss x h n or the rutting tool, takcn Tbe present invention may a h . . ~ b C viewed a an excis along line B B in FIG. 6. sional biopsy device, comprising: M FIG. 8 shows another embodiment of a culting tool a single use disposabk tubular member having a window suitable for use with the excisional bidpsy device acmrding near a distal tip thereof. the tubular member including to the present invention. a cutting tool. a distal end of he cutting 1041 being f R G . 9 is .a cross-sectional schematic o the tubular attacbed near the distal lip of the tubular mcmbcr, at w m b c r 110. to illusirate the relative placemena of tbr le@ a distal ponion of the cutting 1001 k i n g coofig- 65 cutter window 120 and of the t r a d u c e r 270 about the ured to selectively bow out of the window and to retract circumference of the rubular member 110. Unnecessary within the window; and details have been.omitted for clarily.

8

.

NE0 02134

Case5:07-cv-05740-JF Document25-3
.-

Filed06/24/08 Page16 of 23

6,022362
.the distal end o the cutting tool 125 is attached near the f distal end o f the tubular member 110 or lo rhc disral-mmt according to the present invention. point 121 o f the cutter window 120, the portion thereof DESCRIPTION OF THE PREFERRED. exposed through the cutter window 120 tends to bow EMBODIMENIS 5 outwardly. extending out of the cutter window 120. a s shown in FIG. 1B.Tbc extension out of the cutter window FIGS.1A 1B aod 1C show an e m b o d h e m of the distal 1u) and the degrce of bowing may be controlled by the region 105 of the exckional biopsy device 100 according to physician. by appropriate action on the push or turn knob the present invention. Considering RGS. lA, IU and IC 226. Thus. the possiblc range of extension and bowing is collutivcly, thc distal y@on 105 uf h c cxcbional biopsy potentially infinite. being limited- only by the physician's O dcvicc I U indudrs a generally tubular membcr 110 having ability to control the cutting tool US by Socly pushing and a generally tapered distal tip 115. The d u a l tip 115 is reU,acting the push or turn knob 226. Thc degrcc of configured to peneuate soft tisue. such as breast tissue, lung f extension, a s well as the shape o the bowed portion of the tissue. liver tksue a d the wte. Preferably, therefom. the cutting tool. therefore. may be mntrolled by sel&tively distal tip 115 and the distal region 105 o f the excisional biopsy device 100 present a smooth. and relatively atrau- ,s sliding [he cutting tool within lhe internal guide UO of the 1. tubular 'member 1 0 malic profile to rbc soh tiuue in which it is designed lo penenate. Alternatively, the tip llS may be sharply pointed The shape o the bowed portion and the ease with which f the distal portion of the cutting tool 125 bows outwardly and!or may include an energy source (001 shown) to facili1 tate cutting through the tissuc. The tubular member 1 0may may be varicd b y varying the physical charaderislics of the cutting mol 125. Preferahly, the cuning tool i. formed of a be formed of rigid and hard plastic. o r may he made of stainles slut, for example. Preferably. the tuhular memher rccilient. readily deformahlc material that, when unstresxd. 100 is used once and disposed of, for both safety and returns to ils original unhiased configuration. For example, functional reasons. a nickel titanium alloy may be w d for the cutting tool 125, to allow the cutting tool 125 to exhibit shape-memory A cutter window 120 is dispascd within the tubular 1. member 1 0 The cutter window 120 may be, for example, zs characterklics. Thc shape of the cutting tool 125 in its bowed and extended mn6guration (FIG. 2) may be further n a shallow uencb formed i the tubular member 110. As best conlrollcd by varying, for example, the thickness of the seen in FIG. IC,the cutter window UO may be a shallow cutting tool over the portion thereof exposcd through the and substantially rectangular wench in the tubular member cutter window 120.A locally thicker portion of the cutting 110,or may he, for example, a thin, shallow I-shaped trench. s tool I25 will not bend a readily a s a locally relativcly The excisional biopsy device I25 includes a work element, thinner portion thereof. Judiciously v a v i n g the thickness, s such a a cutting tool 125.Tbe distal end of the cutting tool for example, of the cutting tool 125. therefore, allows the U is attached to the tubular m e m k 110 mar i s d b a l tip S curvature of the bowed portion thereof 10 be controlled. 115.For example, the d b a l end of the cutting tool 125 may be attacbed tu thedistal-moa point 121 ulthccuttcr window Asshown i FIGS.1A. 1B.and with rcfcrcnw toRG. lC, n 120. 'lbe cutting tool US. however, may alternatively be 35 pushing on the push o turn knob 226 (or any such funcr attached to other p i n t s within Le distal region 105. The tionally equivalent stmcture) causes the cutting tool 125 to throueh the distal Donion of the cutliorr tool 125 is ex& bow outwardly and extend out from the cutter window 120 cutter window l20.There&aining portionof the cui&gtool o the tubular member 110,a shown in FIG.l .Similarly, f s B 125 i s disposed within an internal guide or lumen 130 of the retracting the push or turn knob 226 (or any such functiongenerally tubular member .no.The. internal guide 130 40 ally equivalent structure) causes the cultkg tool 125 to constrains the movement of the cutting tool 125 and allows flatten out within the cutler window 120 and to assume a to configuration (sbown in FIG. 1A) that may be substadally the cutting tool 'u5 fie+ slide therein. parallel to the l. f l u h with the outer surface of the tubular member 110.In longitudinal a r k of the tubular member l 0 With particular reference now to FIG.2C. the proximal portion 225 o the f this configuration, the tubular member 110 may easily s cutting tool 125 emerges from the internal lumen 130 near 45 penetrate soft tissue, such a breast, lung, liver or other .wft the proximal end 215 of the tubular member 110. The body tissue. In operation, the surgeon makes an incision into the proximal.end of tbe cutting t a d 125 may, for example. m patient's skin, such a s the surface or the b r e d . W e . exdinclude a push or l knob 226.The push or turn knob226 sional biopsy d e v i a 100 itm may bc duccrly introductd. allows Be operator of Ibe excisional biopsy device 100 10 push the cutting 1001 US in Ihe cliscal direction so into the breast tissue. o r an expandable sheath (shown at selrctive~y (away from the physician and loward the distal tip 11s)of reference numeral 495 ii FIG.U)may hi introduced into r the incision and hereafter expanded as the excisional biopsy retract the cuttingtool125 in the proximal direction (toward device 100 is introduced therein. I n any event, theexcisional the physician and away from the distal tip 115). To assist in controlling Ihe movement of the cutting tool 125. the cutting biopsy device is introduced io10 4he breast tissue itself and tool is preferably biased in the p i o x h a 1 direction. as sym- ss positioncd. for example, adjacent to the lesion in the breast I. or adjaccnt thc target site from which thc cxcision i to takc s bolized by the arrow 227 in F G 2C.This biasing may be placr. Durioy thc introduction or the cxcisionill biopsy effectuatrd by means d a spring 228 attached ai or near the 1 dcvicc 100 into thc Sufi tissue. the cutting tool 125 is in ils proximal end 215 of the tubular member 1 0 and to the In retracted configuration wherein the portion thereof exposcd proximal ponion 225 of the cutting tool U5. this manner. tho default configuration of the culling tool U5 i the M through the cutter window Ull is substantially flat. 'Ihc s retraned position. wherein the cutting tool 125 lies substanexcisional device 100, in this configuration. Ihereforc. exhibits a smooth and tapered profile to the surrounding tially Rat within the cultex window 120 of the tuhular member 110. tissue. Once the device 100 has been determined to have The cutting tool U .w h o pushed in the distal direction s beenproperly posilioncd within the soft tissue, the deviur. is by the physician applying prtssure in the distal dirwtion on 65 rotated about its longitudinal axis. Tke r o t a h may be carried out manually, or the rotation of the device may be the push or turn knob 226 or equivalent stmaure. slides carried out by a motorired unit disposed within the proximal wilhin the internal guide 130 of the tubular member 110.As
kIGS. 10-17 show another embedment of a cutting tool

9

10

,,,

'

.

-

'

'

NE0 02135

.. Case5:07-cv-05740-JF Document25-3

Filed06/24/08 Page17 of 23

6,02232
region of the device 100. As the device 100 rotates. the device 100. to a fluid rcservoir. ' h e fluid reservoir. which surgeon causes the cutting tool 125 to bow outwardly and to may be internal or exlcrnal LO the proximal scaion of the device 100. suppliesthedisbt portion of Ihc cutting tool 125 cxtend fmm the cuner window U0. Prcferahly. the degree o f bowing and outward extension is at least suEiaem IO include . witb. for exampk. anaesthetic (such as, for example, s thc lesion (such a the targeted micncalcification within the 5 lidocaine) and'or antibiotic fluid. In this manner.such anaesbreas) within Le space behveen the wtkr window 120 and thetic and/or antibiotic fluid (or other fluid) may he dclivcred precisely to the tissue surrounding the cutting tool 125 as it the cutting tool 125. Tbc cutting tool I25 cuts the t h e a s rotates. A preciwly dawd anaestbetic. for example. may be lhe device 100 is rotated. therebyscvering the lesion from its surrounding breast tissue mass. By completing at least one delivered to the very site where it is most needed. As such riwlution within the hreasl tikuc. the cutting tool 125 anaesthetic is delivered only where it i needed. the effect s swrrps a volunx ut rcvolulion of bred tissue a d wsrs thercof is ncar instantaneous. and h e paticnt fecls littlc OT no that volume fmm the main tissue mas. Such volume or pain as the excisional biopsy device IUU according to thc revolution includes at least the targeted lesion. Preferably. p r e s n t invention is rotated within her breast. or other soft tisrue. RG. 5 shows a cross-section of the cutting tool I25 the volume of revolution severed from the main tiwe mass not only iociudes the targeted lesion. but also includes a Is of.HG. 4, taken along line AA' in HG.4. margin of hca1hY tissue - u d h g Ibe lesion. The Care should bt exercised in selecting the configuralion of extension and b0-g of 125 may be and materials for the cutting tool 125 sbown-in FIGS.4 and 5. Indeed, tbf configuration and materials selected should varied wihin a @wn rcvohtfion of the excisihal biopsy devi= 100. inthismanncr.itispossibletoexertfinecontrol allowthecuftiogtoollt5tobowandcxtendoutofthecutter Over ihc of tissue CUI away. from the main lime window 120 of the device 100 without. however, pinching m a 4 2 Well a s fine control Over s of thc mvcrcd or substantially disrupting the flow of fluid delivered via the lTlaS5. internal lumen ItRofthccutting tool 125.if the cutting tool After the lesion and preferably a margin of healthy tissue 125 is provided with such. For example, the cutting tool 125 around the lesion have been severed. the severed tissue may may be made of a shape-memory metal. such as nickelbe removed from the main tissue ma.= This removal of h e titanium andior the proximal portion or tbe cutting tool 125 scvered risrue may he effectuated by any number of m a s en. may be formed relatively thicker than othcr portions thered. including the retraction of the excisionat biopsy dcvice 100 Another emhdiment of the cnttiog tool I25 is shown in from the .main. tissue m s . Alternately, severe& tissue FIGS.15 and 16. As shown therein. the cutting tool 125 may extraction may be canid out by means of the SINCNTC and be formed by a thin sheet of steel or shape memory alloy. method to be described below. . M The sheet may include a plurality o f through boles 126 lo m e cutting tool 125 may, as S ~ O W Oin FIG. IC, be allow the anaesthetic or other fluid lo he instilled thenconfigured a s a thin ribbon. Thc thin ribbon I25 shown in tIuou&. A small tube 540 may t disposed on thc sheet, x FIG. IC is preferably sharpened OD its leading edge to aligned with the &rough holcs 126. The shcct may bc folded facilitate cutling through lissue and soloclimes fibrous and in the direction indicated by the arrows 530. thus searing calciiied masses. The leading edge of the cutting tool I25 i s 35 the lube 540 between the two folded sides of the shcet. The that edge thereof that &sl comes into contact with the tissue edges55Oof the sheet maybe sealed together to render them s s to he severed a the device 100 i rotated. Such a sharpened fluid tight. For example. the sides 550 o f the shect may be leading edge is shown in FIG. 4 at reference numeral 127. welded together or secured by other means known lo those Tbe width of sucb a ribbon cutting tool 125 is preferably of skill in the metal working arts. The edges 560 between thc smaller &an the widlh of the cutter window 120 into which an through holes 126 may he sbarpened. to allow the cutting it reccdcs when the cutting tool 125 i retracted in the s too1 1 5 to efficiently cut through soft tissue. As shown in 2 proximal direction. FIG. 16, the tubc 540 may deliver anaesthetic or other h i d Another embodiment of the cutting tool 125 is shown in to the cutting tool 125, which delivers minute amounts FIG. 8. To decrease the forward resistance of the cutting tool hereof precisely where it is needed: where the cuuing edges 125 a it slowly cuts through h e . the leading edge of the 4.5 560 of the cutting tool 125. thereby affording the patient t ponion thercof e.xposed through the cutter windowl20 may immediate rclief and minimizing the amount of anaeahetic be serrated, including a plurality of Fetb 127. lo ~ m the , f that need be delivered. The proximal end o the tube 540 leading edge of the plurality of teeth 127 may include a may he io fluid communication with an anaesthetic reservoir sharpcnd dgc. In this manner. as ths cxrisional dkvicxAltU (001 shown) andior an anacsh& pump ( a h not shown). iotatcs. only tbe fonvard-most tips of thc twth U7 will Io Alternatively. the cutting tool I25 may include a hin initially come into contact with the t+e to be CUI, thus wire, such as shown at L 5 in FIGS. 6 and 7. In his case, an E reducing the tissue surface upon which the force of the external radio frequency (hereafter. RF) power source 240 cutting rotating cutting blade 125 is applied. Ib~.lk blade (shown at 240 in FIG. 2C) supplies Ihe cutting tool 125 with 125 of FIG. 8 i believed t be highly cffcctive in cutting s o RF energy via two bipolar electrodes (not shown) attached through even relatively dense or fibrous tisue while mini- 55 to the cutting tool 125 of FIG. 6. Other energy sources may mizing the t o q u e to be applied to the excisionat biopsy also be liscd within the context of the present invention, R F device 100 as it is caused to rotate w@in the mpin soft tissue power being discused herein for illmtrativc p u r p w s only. mass. The RF power dclivered by the RF powcr w u r e 240 allows Referring 10 FIG.4 and also to FIG 5. the cutting tool 125 the cutting tool 125 of FIG. 6 to become an electrmurgical may further comprise a n interior lumen I28 running an 60 cutting andcor an eltctrocoagulating tool hy selectively r entire lengtb o a portion of the lengrb of the cubing tool varying the power applied to the cutting tool 125. Suitable 125. The culling tool 125 may funher include a plurality of generalots for such an ekctrosurgical cutting device 125 are through boles 126 in the distal ponionof be cutting tool 125 known to thow of skill in this an. An example of such a exposed through the cutter wiodow EO. The pluralily of suitablc generator is dcscribcd in US. Pat. No. 4,903.696 through holw 126 arc in Euid communication with the 65 issued Feb. 27. 1990 and assigned to Everest Medical internal lumen 128. lo use. the internal lumen 128 may be Corporation. Brooklyn Center; Minn.. the disclosure of connected. io the proximal portion of the excisional biopsy which is incorporated herewith in ils entirety. A s with the

11

12

,"

:

~

NE0 02136

Case5:07-cv-05740-JF Document25-3

Filed06/24/08 Page18 of 23

6,1322,362
cutling tool USshown io FIGS.4aod5. the cutringtml 125

against the ooter surface of the tubular member 110 or of AGS. 6 and 7 includes an internal lumen 128 and a slighilyrecessed within the cutler window 120 during k r tion thereof into the soft t k u c . 'Ihe m l l e a b n device 260. plurality of through hoks 126 to allow anaccthelic or other fluid to bc deliverd to the surrounding tissue as the cutting thctcCorc. uLrs liitk additional drag and nsistaoce to the % tool 1 . CUIS Ihmugh the soh tisuc as .the &vice 100 is 5 device ,100 a it is imcncd into the incision made -in the 25 rotated. patient's skirt during or prior to the procedure. Suitable As alluded LO above, the cxcisional bo s device 100 i py materials for the tissue colkcrion device 260 include plaaics . and ~ylon. example. Any strong adhesive may be utilized for aaordingto the present invention cuts out a (nor ncassanly symmetrical) volume of rwolutim as it CUIS thmugb Ibe soft to s.wurc thc k u c colkdion dcviu: 260 to the tubular tissue upon mtation of Ihe generally tubular member 110. Io member'U0 and lo the culling tool 125. Other mcans I$ 'Ibis =vend mass of h u e may be srabilizcd using an securing the collection device 260 may also be employed extendable t k e aochoriogdevice, which' anchoring device witbout. however. departing from-the r o p e of the prcseot invention Likewise. the tissue collection device 260 may be a h assists in the retrieval of the severed tissue sample from formed of a material other than spec&cally enuinerated the brezst. The anchoring device may. for example. include rigid anchor member ' 5 herein wbilc remaining within the spirit of the present a suction device or other sub~antially I anchor the tissue sample.Altcrnatively, the severed tissue O inventioo. Preferably, h e &ape and size or thc tissue colsample may be collected io a tissue coUection &via. as lection device 260 are such as to minimize drag on &e U excisional biopsy &vice 100 as it is insened and rotated into s b w d at reference numeral X in FIGS.2A and 2B.'Ihc lissue oollcction devicc 260 is attached externally to the the tissue. For example. the tissue collection d e v i a 260 tubular member 1 0 and preferably also to the trailing edge 1. preferably should be only as large as necesary to contain the of the culling tool 1 5 The tissue mllcction device 260 is 2. excised tksuc sample. preferably formed of a thin and flexible plastic membrane Tbeexcisional biopsy device 100 accordingto the present Sbpcd like a bag. Tbe opening of the bagshaped collection invention is preferably accurately positioned adjacent to the s lesion within the breasi or other organ. Toward that end. the d e v i a 260 i preferably cocxlemivcwith the opening 120 and is preferably attached to the tubular membcr 110 and to 25 prcscnt invention allows the surgeon in gain near real time the uailbgedge of the cutting luoll25. In this manner, the orreal time information as O the intcrnalstruccurc ofthesoft I tisue during the proadure iwlf. Referriog now badr to dpeniog or "mouth" of the bagshaped colledon device 260 opens and closes along with the bowing and retraction. FIGS. 1 and 2C. Ihe present invention may include a tranducer 270 mounted within the disral ponion of thc respectively, of the cutting tml125. Indeed. the "mouth" of the bagshaped collccti~l device 260 i opened when the M tubular member 110. This transducer 270 is preferably s adapted LO image tissue about-io be cut by the cutting tool cutting tool I25 is bowed a d extended out of the cutter window 120 and s u h n t i a l l y c l a d when thc samc is 125 as the cxcisional biopsy device 100 is rotated within the rerraaed within the cutler window U .as the two edges O soft tissue. Indeed. the transduar 270 preferably gcncrales (me attached to the tubular membcr l l o j ~adjacent lo the ~t inlormation relativc to the t k u c about IO bc c u t - h a i is, edge of the culler window l20 a d the other attached tothe 35 t h e that thai has not yet been brought into contact with the trailing edge of the cutting tool 125)of thecollection device cutting loo1 125 25 the tubular memher 110 rotates ahout its are then pre,sscd together. longitudioal axis. In his manner. as the rotational speed of the excisiooal~biopsy device 100 is preferably quite slow Tbenfore. when the excisional device 100 is & r i d into soft tissue and mated. the cutting tool 125 may be caused ( h e rotation may be manually carried out or may be caused lo bow and to extend ouhvardly from the cutter window 120 40 by a slow moving motorized unit attached to the tubular ma member 110). h e surgeon may evaluate h e information and c a w d to cut tLsuc Luming into a t u thcrwitb. As the devicc 100 rotates and cu& the tissue between the generated by the transducer 270 and may. based upon this cu!ting tool 125 and the tubular member 110 teods to information.vary the degree of bowing and extensioo of the cutting tool 125. For example, when the device 100- is advance toward and into the collection device. As the cuning tool I25 is in its bowed and extended shte, the "mouth" or 45 positioned adjacent to the lesion of interest and rotated. the transducer 270 will detect the presence and location of the opening of the bag-shaped mllec~iondevice 260 is also lesion before the lesion comes into contact with the cuttihg cooncspondinglyopen. allowiog the severed h u e ID oollcct. tool 125.After the lesion has been detected by the transducer therein. As the revolution of the tubular member 100 is 2 270,the surgeon may push on the push or Iuro b b 226 or wmpleted. Iheculling tool 1 5 may be retracted and cawed to assume a conliguralion wherein it is dbposcd w t i the rn other stmc~uw ihn that causes the cutting tool to bow and extend from the cutter window U0. The lesion (and preferably an recessed cutkr window 120. substantially Bush with the adequate margin of healthy tissue) will then be severed from mter surface of the tubular member 110, as shown in FIG ZH.In thisconfiguration. the colknion device 260 isclnced, the main mass. and optionally mllecled. for example, in the tissue coUeaion d e v i s 260- When the transducer 270 thereby securing the exc-ked tissue sample tberein. The device 100 may then be safely retracted fmm the.maio t i w e 55 indicates that the rotation of the tubular member has brought mass. such as the brew. As the excised sample i physically . the cutting idol 125 past-tbe.Iesion. the cutting tool 125 may s o r n be retracted within the cutter window E . h c Lutting. it can OT b l a t e d h the remaining tissue m a s , h e probability of seeding the surrounding tissue with potentially abnormal beseen, may bespecifically tailored to the size and shape of cells is markedly decreased. 'Ihis probability is a h further the lesion within the main tissue m a s in near'real tiox or in decreased. a s the excisional device 100 according to the 60 real time. thereby allowing the surgeon to excise all of the present invention allows the surgeon to obtain adequate tissue requirtd and only the tissue that is n e a s s a y lo marg;ns of healthy tisue surrounding the target lesion -by achieve the intended results. cboosing the degree of bowing and exiension of the cutting Preferably, the transducer 270 is an ultrasound x c m r tool 125. lo this manner. the integrity of Ihe lesion ilsclf i s mounted substantially flush with the external surface of the not violated. hereby maintaining tissue architecture intact. .6s tubular-mcmkr I l 0 . m ultrasound S o n w 270 is preferably As the collection device 260 u preferably formed of a thin electricaUymnnected, via a communication channel such as and flexible membrane, it is able to lay substantially flat electrical conductors. to a t least one data processing and

23

14

NE0 02137

Case5:07-cv-05740-JF Document25-3

Filed06/24/08 Page19 of 23

...

6,022,362
15

16

.

display devicc, shown at reference 250 in FIG. 2C.'Jhe data according to the ptcsenl invention. Although tlGS. 3A-3C illustrate an embodiment of the present invention within the p'occssing and display device(s) 250 allows the surgeon to context of hreast surgery. it is to be undeislond that -the see. in near real time or in real time. the internal SINC~UIK of the tissue about tu be CUI by the cutting 1 ~ 1 1 2 5 . This:allows p r w n t inventive method is eQuaUy applicable to other soft s r the surgeon not only to see a graphical representation of Ihe .c tissue masses, such a. for example, lung, thyroid o liver internal slruaurc of the tissue during the procedure itself. tissue, wilh only minor modifications which will become apparent to skilled pra$itioncrs in this an. but also allows the surgeon to assure himxlf or hersclflhat the entire lesion or group of lesions has been properly . in -j-uming first L ~ G 3~ a mall,inckion 331 t: excised by, for example. rotating the tubular devi= within -the bX+u 31U. preferably in the peri-arwlar region. The the tissue while the cutting tool is retracled within the cutter of [he &ice 1~ that outsik of [hc jorl Ihe uansduar 270 is Viewed tissue may include attachment means(nnt shown) for c l a m p from another aspcct. therefore, the present invention is an inlra-[r?;sue imagiwdcvirr: may, but ingihe device 1 0 a rimuru'=mre. example. 10 allow Qahk include a such as by numeral in operation and prcciwguidance thereof The small incision is preferably made on Ihe border of tbe areola 330sunounding thefigures In upcration, (e.g,, ullrwund) Irans;ducer s w ~ p sa IS the nipple 320. this provid- a better asmetic Scar than or!he brcau 310. Dopndingon Ihe IhC Skin plane (graphicany &own a[ 2 1 is FIG 3A) within [he 10 tisuc a h a d elemrn). as lwl 5 . siU:of the lesion and the size of the exL5siooal biopsy device ~ 'Ooto be inartdtbeKin;an expandable sheath (an In seleuing the operational characterictics of Ihe ultrasound of whicb is shown at refeIeoce numeral 195 in FIG. 13)Nay balance [he required 270, resolution (i.e., the feature [hat mus( be discemable) 211 he inserted into the hrcast lirwe. In any event. the excisional of f i e u]trasound w a v ~ -biopsy device 100 is inserred into the breast tissue and with the degree of positioned adjacent the lesion 300, which may be. for within the tissue and the inlensity ,of thc ultrasonic waves generated. In general. higher frequencies allow.bener resoexample. a microcalcification or other abnormal lesion. O n e in position, the device 100 is, rokaled. for example. in lution. However, high frequencies do not penetrate the tissue as far a s do lower frequeocy ultrasound waves. Preferably. 25 the direction indicated in FIG. 3A. The portion of the the ultrasound t r a d u c c r 27U is t u r d within the range Gum excisional biopsy device IOU that remains outside lhe soft about 5 MHz 1 about 20 MHz. More preferably. the 0 tissue may have a greater diameter than the portion thereof ultrasound t r a d u c e r 270 is tuned witbin the range of a b u t lhal is designed to the tissue. mis aids in 7 5 MHz to about 20 MHz. For example. in the case wherein manual of the device 100. ln the Ihe excisional biopsy device 100 amording 10 the p . W n l 3o depicted in HG.3& the futliog tool 125is retracted within the cutler ,,,indow 120 and [he be collecrioo device 260. invention is used within the female breast. the ultrasound lramducer may be within Ihe rangcOf about loMHz if present, is su&tantialLy Bat againa the external surraw of to about 13 MHz. the tubular mcmbkr 110. ?he dtvim 1 1 U is rotated about its Tu effectively imagc the internal tissue SIm~Aurc pnor tu and t b 270 is eoerg~a., Ik c'Jltinl: it with. for cxamplc. thc LXtling tool 1%. 3s information therefrom being transmitted Io. for example. the display device 250 shown in FIG;. 2~;. When transducer 270 must k positioiled within the tubular memlesion 300 ih comes into view, the surgeon then gauges the size, shapc and ber 110 away from the Win!. tod 125. wt reference 10 FIG 9. the transdumr 270 nlay he a;sposcd within !he location thereof and controls tbe bowing and extension of tubular member at an angle a relative to the cutting tool 125. [he w o k element, such as cutting tool 125 based on [he 10 40 information received from the mausducer 270 and displayed The angle a is preferably no smaller than that ne-ary effectively control the operation of the work element (sucj~ upon me display 250. RG. 3~ dcpids sjtualion whenin the lesion. 300 has been i m a g d and the surgeon has as culling element 125) in response to information galhered from the transducer 125 as the tubular member 110,rotates. extended the Ntting tool 125 to Sever the lesion 300 from This an%e a. thcrcfore. is dependent at leas1 Upon the the surrounding breast tisue. The severed !issue may he ro~alional speed h p o d upon [hc tubuhrmcmbcr 110 and 4 s received and collected in a tissue collection device 260. as the device 100 rotates. Anaesthetic and;or antihiolic (or upon the time necessary for the surgeon to assimilate the i~formation generated by the lranducer and 1 effectively 0 other) Huids may be delivered directly to rhe affected tissue by though holes 126 (best Ken in F I G S , .20~ RGS. ~ and control the cutting tool 125 in response to such information. Preferably, [be angle a is ks.~ than about 180 de@-. , 4-7). Ipdtly drctrzsinp pain during the proculurc When W d in CUnjUnCliVO with an intra-tissue uhra.WUlld 50 After the l a i o n and any desired ma@ of heallby lissue sansduccr, such as shown a1 270, thc exdsiooal biopsy is severed from the main breast t h e mass. the cutting tool devioc 100 according to the present invention may k l u d e 125 is retrackd within the a l t e r window 120. This ~ 1 a variety of work elemenls in place of or in addition to the the [issue ao]lec~ondevi& 260. if present, and allows the entire device 1 0 10 be relracld. frorn he breast in the 0 cutting tool 125. Such work elements include, for example. an abrasive device, a recipmcaling cutting device, an ClcC- 55 diechon of m o w 350, as shown in FIG. 3c. If the tissue collection device 260 is present. the lesion 300 will be lrosurgical device or a vibrating device. In the case of Icsions within the breast. it k useful to b l a t c d from surrounding tissue by thc.membrdne of the stabilize the brcas prior to imaging and pcrforhing invasive tissue cullcctiun dcvicc. 2Mt. thus minimizing any pusibdity of seeding pntentially abnormal cells to surrounding hreau procedures. Such stabilization is conventionally performed by compression plates lhat squeeze the breast and compress 60 tissue. Moreover. the tissue architecture or the retrieved s lesion300 is substantially preserved. thereby allowing accuthe tissue therein. Such compression i necessary to allow rate histopathology to be performed upon the entire mass x-ray radiation, a s used in mammography. lo produce a us~ful image. Although such mmprcssion i s nqf needed or excised tiom the breast. Indeed. any compression such tissue may undergo is bclicved tu be wlely due to the retraction o f believed to be desirable according to the presenl invention. stabilization uf the brcast remains nurssary. 6 5 , the dcvict: back through the cnlranct: track of the devict: 100 Reference i iiow made to HGS. 3A. 3 8 and 3C. which s in the uncompressed breast tissue. 'Ihereafter, when the excisional device 100 is removed from the breast 310. the illustrafe an embodiment of the excisional biopsy method
'

~

s

NE0 02138

Case5:07-cv-05740-JF Document25-3

Filed06/24/08 Page20 of 23

6,022362 17
push or turn bob 226 may be acted upon to extend and bow acterislics a s the S c m r 270. and may be used alone or in addition to surface ultrasound lo localize the lesion with a the cuuing tool 125. thereby allowing the excised lesion to be retrieved from the tissue colleaion device 260 forcxamig n a t degrec of pmision. FIG. 12 shows a a m M i o n of the embodmeoi o f tbc nation. If tbc tissue collection d w i a L not pmxnt. convcntional suction meam may be employed to extract the 5 excisional device 100 of FIG.10, taken along tine M As . severed lesion from the surrounding breast tissue. Bleeding shown in FIG.1. the cuning tool Its is exposed hrough 2 is cootrdled by suitably varying the RF or other power the transducerwindow I2O.Thc window 120 may. asshown in FIG. 12,includc support guidcs 122 to support and guidc source applied 10 thc electr@Surgical m h % tool n5,if PrcSent. (0 Sem h e bleding by cauterizing &e tissue the ~vttiog 125 a~ it U o u t w ~ d l y 1001 cxkorled and bowed. coagulating tbe blood. I l w tissue c o ~ ~ e d i o n devicr: 2 0 for clarity. i nol shown in 6. s However. to accommo