Mou v. City of San Jose et al

Filing 1347

Mou v. City of San Jose et Case5:07-cv-05740-JF al

Document25-7

Filed06/24/08 Page1 of 15

Doc. 1347 Att. 6

..

412)

UK Patent Application GB 2 31I 468 A
(191

tll)

t13)

(43) Date of A Publicstion 01.10.1937

152) UK CL IEditbn 0 ) A!iR RHCE

(56) DoarmentsCiied

OB 21ua22A
US 46670111A

GB 0618528A

WO 93/24&2 A1

04)

b e n t andlor Addrsss for Service

Urquhmt-Dykes& Lord 91 Wfnpole Street LOMDON, W l M BAH. UnitadKingdom

(57) An electrwurgiwl apparatusfor resecting tissue within a body has an elongatedhollow shaft 16with a ise sharp point at the d i t end, an opening Inthe shaft to allow pasvlge of resea14t s u ,an eledrically conductingdeflectable member locatedwithin the shah and connectedto a supply of RF current 3. and a 3 deflectioncontrol connectedto the deflectable member a the pmxirnelend for deflecting the member t 9 outwardlythrough the opening, eg by know increments using a ratchet 2. Tissue is cut and coagulated by the deflectable member as the appamus is rotatedby a rotationcontrol through a rack and pinion 3132. The sharp tip a l l w the apparatus to be inserted percutaneousb. A source of irrigation fluid 26 and a source of suction 25 may be connected selectively by a rocker switch 28.

L

/I0

FIG. 2

NE0 00562

Dockets.Justia.com

Case5:07-cv-05740-JF Document25-7

Filed06/24/08 Page2 of 15

P

N E 0 00563

Case5:07-cv-05740-JF Document25-7

Filed06/24/08 Page3 of 15

N E 0 00564

Case5:07-cv-05740-JF Document25-7

Filed06/24/08 Page4 of 15

NE0 00565

Case5:07-cv-05740-JF Document25-7

Filed06/24/08 Page5 of 15

u.
n

U

NE0 00566

Case5:07-cv-05740-JF Document25-7

Filed06/24/08 Page6 of 15

2311468
1
.

ELECTROSURGICAL INTERSTlllALRESECTOR

5

Field of Invention This invention relates to an electrosurgi& apparatus. More
particularly, the invention relates to an electrosurg-ml tool for peicutaneously
debulking and removing the prostate or other tissue, and to a method for perfonning 10 debulking and removal of tissue using RF eledricalenergy. Backaround of the Invention Benign prostatic hyperplasia (BPH)is a benign enlargement of the prostate gland resulting in a reduction in urine flow through the urethra. BPH typically affects men over the age of 45 and increases in frequency
15

with age. BPH can result in both obstructive and initative symptoms which can range
in severity from mild reduction in flow to acute retention.

A common surgical procedure for BPH is the transurethral resedion of the prostate (TURP) which removes portions of the prostale through the urethra using a
transurethral resectoscope and electrocautery. TURPSare not without their problems
20

and can result in extended hospital stays, blood loss sometimes requiring transfusion, impotence and incontinence. An additional concern is the absorption of the imgating fluid (TUR syndrome) creating huge increases in cardiac load. Various instruments For perfonning surgical cutting operations in body lumens, for example TURPS, are known in the art

US. Patent No. 5.415.658 discloses an

25

electrosurgicalapparatus for incision of a strictore within or adjacent to a body lumen. The apparatus comprises an eledrically conducting, deflectable wire that is connected to a source of
.

RF electrical current.

The disclosure does not include any

apparatus that would permit or suggest the insertion of the instnrment through the skin, Le. percutaneously. reference and made a part of this disclosure.

30

US ..

Patent No. 3,910,279 discloses an eledrosurgical instrument for

resecting M i r y tissue. The instrument is designed for insertion through an existing

body lumen and into a body cavity. The apparatus is not designed for percutaneous
insertion into tissue. The disclosure aIso does not address the need for a suction or
35

irrigation capability.

NE0 00567

Case5:07-cv-05740-JF Document25-7

Filed06/24/08 Page7 of 15

2

There have been many attempts to develop new.therapies which provide an alternative to TURPs for

BPH. These therapies have been generally directed toward
These therapies indude lhe use of lasers, stents,

less-invasive modahties such as transurethral ablation, although some interstitial methods may be known.
5

cryotherapy, ultrasound. microwaves, transurethral incisions, and dNgS. another.

RF- eledn'cal current, balloons, and Not all of ihese have proven to be very effective

and the ideal therapy for one type of patient may not necessani be the same for Interstitial therapies offer advantages over TURPs by minimizing blood loss,
10

eliminating concerns about TUR syndrome, and reducing the occurrence of retrograde ejaculation by completely sparing the bladder ne& and urethra. Another advantage with these procedures is that patients activities more quiddy than patients -0

can typically resume normal undergo TURP.

Interstitial therapies offer advantages over other transurethral ablation
15

technologies because there is no sloughing of tissue through the urethra after the procedure. Further, interstitial therapies offer benefits over standard hyperthermia technologies because it has been shown that over time, a demonstrable lesion can be created in the prostate. The downfalls with current interstitial ablation methods, as well as with all the
'.

-

20

non-invasive modaliies; is that no tissue samples can be obtained for pathology during the procedure. Even more critical, in all of the known less-invasive therapies, obstruction relief is not immediate and a catheter must often be placed postsurgically. There is yet no known device which can create immediate post-operative relief from BPH obstruction and provide tissue for pathological analysis, without the

25

need for a post-operative catheter. Summarv of the Invention

An interstitial resector, desuiied hereln, may be used for surgery on the
prostate. The interstitial resector uses a wire loop to cut and cauterite tissue that is
30

subsequently sucked out through an &piration port This device is intended to provide the benefits of minimizing bleeding and reducing the likelihood of TUR
syndrome, while obtaining the same rapid obstruction relief and pathological samples as from a TURF.

The present invention I based on the idea of destroying and' immediately s

35

removing tissue from within the prostate while causing minimal damage to the

NE0 00568

Case5:07-cv-05740-JF Document25-7

Filed06/24/08 Page8 of 15

3

prostatic urethra. An advantage of this product is that it combines the b n e f & of
TURPS (immediate obstruction relief. tissue sampling) and interstitial ablation
(minimized bleeding, no damage to the urethra or bladder neck, and qui& recovery) into one produa
5

The interstitial resector may be disposable and may consist of a noid plastic
handle connected to a semi-flexible shaft having a sharp tip. At the distal portion of the shaft, one or more cutting elements cwld be variably exposed. These elements can be energized with electrosurgical current or electrocautery. A suction/inigalion li channel may be within the shaft to inject fud or to remove tissue frwm the operative

10

site. The importance of removing tissue is that it provides the surgeon with samples for pathology testing.

The procedure for use of the interstitial resector may mquire transrectal
ultrasound or transurethral visualization, Once the interstitial resector was inserted

within the tissue. the active element may be moved slightly outward at the distal end
15

of the shaft Upon the activation of energy, the resector would be rotated, thus
cutting off wedge sections of tissue which could then be removed through the aspiration channel using suction. The active dement could be incrementally extended to remove greater and greater lumps of tissue as the procedure progresses. The utilization of electrosurgical energy would cause coagulation of the

20

remaining tissue.

Any post-operative bleeding should be self-limited since the Brief Description of the Drawincts

surgical wound is encapsulated. Figure I a side view of an electrosurgical interstitial resector. is Figure 2 is a schematic cross-sectional view of an eledrosurgical interstitial
25

resector. Figure3 is a view of the distal end of the shaft Figure 4 is a cross-sectional view of the distal end of the shaft showing a

member in its deflected position.
Figure 5 is a cross-sectional view of the distal end of the shaft showing a 3'0 member in its nondeflected position. Detailed Description of the Invention The present invention is an electrosurgical apparatus 10. as shown in Figure 1

for resecting tissue within a body- The apparatus 10 is deslgned for percutaneous
insertion into the body and may be used for operations on the prostate gland. The
35

apparatus is particularly suited for treatment of benign prostatic hyperplasia (EPH).

NE0 00569

Case5:07-cv-05740-JF Document25-7

Filed06/24/08 Page9 of 15

4

The apparatus 10 comprises an elongated hollow shaft

I1 having a proximal

3 end 12 and a distal end 1 . The proximal end 12 of the shaft 11 is connected to a
handle 14 with controls forthe surgeon The distal end 13 of the shaft 11 is designed for contad with the tissue of the patient. The shaft 11 has a hollow interior 1 with a 6

5

diameter sized to allow passage of resected tissue from the distal end 13 to the proximal end 12. In one embodiment the shaft 11 is a needle in the range of 18 to 14 gauge. There is a sharp point 17 on the distal end 13 of the shaft 11. The sharp point

17 is used for introducing the apparatus 1 percutaneously. The sharp point 17 offers 0
10

the surgeon the ability to push the distal end 13 into the prostate without

maneuvering through a body lumen. This feature, in part, distinguishes the present invention 10 from wire resectors with blunt tips. An electrically conducting, deflectable member 18 is located within the hollow interior 16 of the shaft 11, as shown in Figures 4 and 5. In one embodiment, the 15 member 18 is a Wire. In another embodiment, the member 18 has two flat surfaces

19 and at least one sharp edge 20. The sharp edge 20 allows the member 18 to cut
mechanically while cauterizing with eiedrosurgical current The flat surfaces 19 are designed so that the member 18 wiil bow in a predictable manner.
.

In another

embodiment, the member 18 has a preset and permanent bend, so that tension or
'

20

compression on the member 18 will result in a repeatable and predictable deflection. In one embodiment, the member 18 is made from a superelastic alloy. In another embodiment. lhe member 18 is made from an alloy of nickel and titanium. An electrically insulative material 21 is disposed between the member 18 and the shaft 11. as shown in Figures 4 and 5.

In one embodiment, the insulative

25

material 21 is on the member 18 such that electrical current will not flow behveen the

1 member 18 and the shaft 11. In another embodiment, the insulative material 2 is on
the shaft 11. In yet another embodiment, both the member 18 and the shaft I 1 have

electrically insulative coverings.

30

embodiment the opening 22

There is an opening 22 near the distal end 13 of the shaft 11. In one is rectangular in shape. In another embodiment the
The opening 22 is large enough so that resected

opening 22 is oval in shape.

portlons of tissue can be drawn through the opening 22 and into the hdlow interior 1 6

of the shaft 11. as shown in Figure 3 . A deflection control 23 is located on the handle 14. The surgeon can use the
35

deflection control 23 for deflecting a portion of the member 18 outwardly relative to

NE0 00570

Case5:07-cv-05740-JF Document25-7

Filed06/24/08 Page10 of 15

__-

5

the opening 22. In a preferred embodiment. the deflectioncontrol 23 has a ratcheting mechanism 24 that positions the member 18 m

k increments of deflection from n w
the proximal end 12, as shown in

the opening 2 2
A source of suction 25 is connected to
5

-

Figure 2. The suction is used for drawing fluids and tissue inward from the opening

22. The sudion must be strong enough to drawlhe resected tissue through the
opening 22. along the shaft 11. and out beyond the proximal end 12 of the apparatus

10. The tissue and fluids are then collected in a standard trap for later pathological
analysis. 10

A source of irrigation fluid 26 is connected to the proximal end. The irrigation,
fluid can be directed through the shaft 11 and out of the opening 22. In the preferred embodiment, a suctionlinigation switch 27 mounted on the apparatus 10 near the proximal end 12 is used for selecting either sudion or irrigation in the shaft 1 . The 1 switch 27 is connected to simple trumpet vahres 28 to open and dose the ports to the

.

15

sourms of suction 25 or imgation 26, as shown in Figure 2

Inthe preferred embodiment, the suctionhnigation switch 27 i a three position s
rocker Switch. The rocker Switch 27 i biased such that no suction or imgation fluid is s applied at the opening. When the switch 27 i depressed in a first direction, the s

6 source of irrigation fluid 25 is connected to the interior passageway 1 ,thus providing
20

irrigating fluid through the opening 22. When the switch 27 is depressed in a second direction, the m c of suction 25 is connected to the interior passageway 16, thus re providingsuction at the opening 22.

A rotation control 29 i connected near the proximal end 12 of the shaft 1I to s
provide the surgeon with a mechanism for rotating the shaft 11 relative to the tissue.
25

When the member 18 is extended from the opening 22. rotation of the shaft 11 causes the member 18 to resect the tissue. In one embodiment,

the rotation control

29 may be a knob which

I rigidly mounted to the shaft 11. In the preferred s

embodiment, the rotation control 29 is a lever which has a pivot 30 that alkws motion back and foith along the direction of the shaft 11. A rack 31 and pinion gear 32 train 30 connects the lever to

be shaft 11 such that the pivotalmotion of the lever produces a

rotational m o k n of the shaft 11, as shown In Figure 2.

A.sowce of RF electrical current 33 is connected to the member 18. The source of RF electrical current 33 may be any of the commerdally available
electrosurgical generators, for example the Force FX Eledrosurgical Generator

35

manufactured by Valleyiab, lnc. in Boulder. CO. An eledrical switch 34 connects the

NE0 00571

Case5:07-cv-05740-JF Document25-7

Filed06/24/08 Page11 of 15

6

soum of

RF eledn'cal current 33 to the member 18.

Standard medical grade switch

technology can be used.

A method for using the eledrosurgical interstitial resedot 10 is atso herein
described. The method comprises the following steps: introdurn the apparatus 10

5

into tissue by forcing the sharp point 17 ihrough the tissue; deflecting the member 18

10

such that the member I 8 protrudes through the opening 22; appjjing electrosurgical arrent through the member 18; rolating the shaft 1 such that the protruding portion 1 of the member 18 resects tissue from the body; drawing the resected tissue through the shaft 11 with suction. and inigab'ng the tissue by forcing irrigating fluid through the shaft 1 and out of the opening 22. 1

15

NE0 00572

Case5:07-cv-05740-JF Document25-7

Filed06/24/08 Page12 of 15

--

7

- 1.

An elcctrosurgical apparatus for resecting tissue within a body, the apparatus cmrsn: opiig an elongated hollow shaft having a proximal end, a distal end, an interior passageway, and an exterior surface;
an opening in the shaft between the interior passageway and the exterior surface near the distal end, and of sufficient size to allow passage of resected tissue;

an electricallyconducting, deflectablemember located w t i the interior ihn passageway and set to deflect through the opening;
a deflection control connected to the deflectable member at the proximal end for deflecting a portion of the deflectable member outwardly through the opening; a source of RF electrical current connected to the deflectablemember; and
a sharp point on the distal end.

2. An apparatus according to Claim 1, in which the deflectable member further includes surfaces which are bounded by at least one sharp edge.

3. An apparatus according to Claim 1 or Claim 2, in which the deflectable member is made fiorn a superelastic alloy.
4.

An apparatus according t any preceding Claim, further comprising an electrical o

switch connected between the source of RF electrical current and the deflectable member.

5. An apparatus according to any preceding Claim, further comprising a rocker switch located at the proximal end, wherein a first position of the switch connects a
source of irrigation fluid with the interior passageway, a second position of the switch
connects a source. of suction with the interior passageway, and a third position of the

switch closes the interior passageway to both suction and irrigation fluid,

NE0 00573

Case5:07-cv-05740-JF Document25-7

Filed06/24/08 Page13 of 15

8

6.

An apparatus according to any preceding Claim, further comprising a ratcheting

mechanism connected to the deflection control, wherein each successive position of the ratchet advances deflection of the deflectable member. An apparatus according to any preceding Claim, further comprising a rotation 7. control located near the distal end and mechanically coupled to the shaft.
8.

An apparatus according to any preceding Claim, further comprising a source of

suction connected to the interior passageway for drawing fluids and resected tissue into the interior passageway through the opening.

9. An apparatus according to any preceding Claim, further comprising a source o f irrigation fluid connected io the interior passageway for sending irrigation fluid outwardly through the opening.
10. An electrosurgical apparatus for resecting tissue within a body, the apparatus comprising:

an elongated hollow shaft having a proximal end, a distal end, an interior passageway, and an exterior surface; an opening in the shaft between the interior passageway and the exterior surface near the distal end, and of sufficient size to allow passage o resected tissue; f an electrically conducting, deflectable member located within the interior passageway and set to deflect through the opening;
a deflection control connected to the deflectable member at the proxima1 end for deflecting a portion of the deflectable member outwardly through the opening; a racheting mechanism connected to the deflection control, wherein each successive position of the ratchet advances the deflection of the deflectable member; a rotation control located near the distal end and mechanically coupled to the shaft; a source of suction connected to the interior passageway for drawing fluids and resected tissue into the interior passageway through the opening;

NE0 00574

Case5:07-cv-05740-JF Document25-7

Filed06/24/08 Page14 of 15

9

a source of irrigation fluid connected to the interior passageway for

sending irrigation fluid outwanliy through the opening, a sourceofW electricalcurrent connected t the deflectablemember; and o a sharp point on the distal end.

11. An electrosurgical apparatus substantially as d e s c n i herein, with reference t . o Figures 1 to 5 of the D a i g . rwns

NE0 00575

Case5:07-cv-05740-JF Document25-7

Filed06/24/08 Page15 of 15

:

_

,

Application No: Claimssearched
patents Act I977

GB 9703792.3
All

ExilIIher: Date of search:

Bob Clark 14 May 1997

Search Report under Section 17
Databases searched

UK Patent Ofc collections. including GB;EP. WO & US patent specifications, infie

UK Q ( d 0 A5R (RHCC.RHCE) E.) :
Int C1 ( d 6 : A61B 17/36. 17/38. 17/39 E.) Other: Online database: WPI

Documents considered to be relevant: Identhy of document and relevant passage
to Claims
1.4 1.4.1-9 1.4

RCkVaM

X
X

GB2156222 A
GB0618528A

(OLYMPUS WINTER) Whole document (AMERICAN CYTOSCOPE) Whole document

X
X
I

WO93L24062 A1
US4657018

o (LAPAROMED) Line 15 on page 11 t line 18 on page 12
(HAKKY) Line 17 column 5 to line 5 column 6.

1.4.8.9

NE0 00576