System for ContinuousFlow Lithotripsy

US Design Patent: US D715, 921 SUS Utility Patent: US 14/341, 905.

Revolutionary Technology in Stone Management

ClearPetra

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B E N E F I T S

Reduces Intra-luminal PressureA vortex i s c reated by the cont inuous i r r igat ion and suct ion . I t reduces the operat ional ( int ra- luminal ) pressure and reduces the r i sk of surgery .

No More Stone RetropulsionE�ect ive ly prevents ret rograde stone migrat ion with Negative Pressure Aspiration and at the same t ime removes the s tone f ragments .

Improved Visual FieldUnder the cont inuous i r r igat ion and suct ion , b leeding and dust s torm f rom stone pulver izat ion no longer obscure the v isua l �e ld .

Improved Stone ClearanceStone f ragments wi l l aggregate at the d is ta l end of the C learPetra sheath instead of scatter ing and are removed through the obl ique s ide port on the C learPetra Sheath by the cont inuous suct ion .

No Accessory Device RequiredStone baskets , forceps , and ant i - ret ropuls ion devices are no longer necessary . Under the Negat ive Pressure Aspi rat ion , the s tone f ragments are evacuated spontaneous ly .

PROBLEMS DURING ENDOSCOPIC LITHOTRIPSY

The ClearPetra System for Cont inuous F low L i thotr ipsy of Wel l Lead Medica l i s des igned for the e�ect ive and

e�cient t reatment of ur inary s tones us ing N e g a t i v e P r e s s u r e A s p i r a t i o n through an obl ique s ide port on

the C learPetra sheath . I t has h igh stone c learance rate , reduces the int ra- luminal pressure in the ur inary t ract ,

prevents s tone ret ropuls ion , improves v isua l �e ld , obviates the need of s tone baskets , forceps , or any ant i - ret -

ropuls ion devices , and saves operat ing t ime 1.

Stoneretropulsion

Obscuredvisual field

Difficultiesin extracting

residual stone fragments

High intra-luminal pressure in the urinary

tract

I N D I C A T I O N S

ClearPetra Ureteral Access SheathUse for renal s tones , uretera l s tones , uretera l s te inst rasse

ClearPetra Nephrostomy SheathUse for renal s tones and upper uretera l s tones

ClearPetra Cystoscope SheathUse for b ladder s tones

Stone Collection Bottle Use for co l lect ing stones

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Advance the C learPetra sheath over a guide wi re unt i l i t i s wi th in 1 cm of the s tone or s te inst rasse . Remove

the obturator and place the rubber cap onto the prox imal s t ra ight end.

Connect the obl ique tube of the C learPetra sheath to a negat ive pressure aspi rator or to the s tone col lec-

t ion bott le with the c lear tubing (packed separate ly ) then onto the negat ive pressure aspi rator . Act ivate

the suct ion at cont inuous mode and mainta in the pressure at 150 - 200 mm Hg.

Insert the endoscope through the center aperture of the rubber cap and turn on the cont inuous pressur-

ized i r r igat ion at a �ow of 50 to 100 cc per minute . Advance the scope to the s tone or the s te inst rasse .

Commence the l i thotr ipsy us ing a Holmium-YAG Laser or pneumat ic l i thotr ipter . We recommend us ing a

h igher f requency and lower energy sett ing on the laser for �ner s tone f ragmentat ion .

When us ing the C learPetra sheath , the negat ive aspi rat ion pressure can be adjusted us ing the pressure

vent on the obl ique s ide port of the sheath , or the pressure contro l knob located on the egress tube of the

s tone col lect ion bott le .

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The red band marks the l imit for

the endoscope withdrawal

Negat ive aspi rat ion pressure can be adjusted us ing the pressure vent on the obl ique s ide port

ClearPetraUretera l AccessSheath

ClearPetraCystoscope Sheath

ClearPetraNephrostomy Sheath

I n s t r u c t i o n f o r U s e

Dur ing the process of l i thotr ipsy , the s tone f ragments tend to aggregate at the d is ta l

opening of the C learPetra sheath . The smal l s tone f ragments wi l l ex i t in the space

between the scope and the ClearPetra sheath . With la rger f ragments that are smal l

enough to come into the C learPetra sheath but too la rge to pass in the space between

the scope and the ClearPetra sheath , wi thdraw the scope s lowly to just prox imal to the

b i furcat ion ( the red band) of the C learPetra sheath . Th is wi l l open up an unimpeded

channel to the obl ique tube to a l low evacuat ion of the la rger s tone f ragments .

Af ter the surgery i s completed , turn o� the per fus ion equipment and the negat ive

pressure aspi rator . Send the s tone col lect ion bott le with s tone f ragments to the

laboratory for ur inary s tone analys is .

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N O T I C E SUse endoscopes at least 3 Fr smaller and 7 cm longer than the ClearPetra sheath

Make sure the t ip of the ClearPetra sheath is within 5-10 mm distance of the stone

Set the continuous negative aspiration at 150-200 mm Hg pressure

Set the continuous pressurized irr igation at 50-100 cc per minute

Turn on the suction before the pressurized irr igation

Flex ib le ureteroscopy

and Holmium Laser

L i thotr ipsy with the

C learPetra Uretera l

Access Sheath in a

pat ient with renal

s tones of 20 x 25mm 2

Example of Procedures with the ClearPetra Sheaths

Removing the obturator; commencing lithotripsy using a holmium laser. Stone dust exited the space between the scope and the ClearPetra sheath.

Advancing the ClearPetra sheath over a guide wire Placement of a Double-J stent

after removal of the ClearPetra sheath

I f any misunderstanding occurs due to print fai lure or misunderstanding of the content, Well Lead reserves the r ight of �nal explanation.

1 Guohua Zeng, Dong Wang, Tao Zhang, Shaw P Wan. Modi�ed Access Sheath for Cont inuous F low Ureteroscopic L i thotr ipsy : A Prel iminary Report of a Novel Concept and Technique. Journal of Endourology 2016 09 24; 30(9) :992-6 .

2 Ghani KR, Sammon JD, Bhojani N et a l . Trends in percutaneous nephrol i thotomy use and outcomes in the United States . J Urol 2013; 190:558–64

3 Zeng G, Mai Z , Zhao Z et a l . Treatment of upper ur inary calcul i with Chinese minimal ly invas ive percutaneous nephrol i thotomy: a s ingle-center exper ience with 12,482 consecut ive pat ients over 20 years . Urol i thias is 2013; 41 : 225–9

4 Desai J , Zeng G, Zhao Z , Zhong W, Chen W, Wu W. A novel technique of u l t ra-mini -percutaneous nephrol i thotomy: introduct ion and an in i t ia l exper ience for t reatment of upper ur inary calcul i less than 2 cm. B iomed Res Int 2013; 2013: 490793

5 Zeng, G. , Wan, S . , Zhao, Z . , Zhu, J . , Tuerxun, A . , Song, C . , Zhong, L . , L iu , M. , Xu, K . , L i , H . , J iang, Z . , Khadgi , S . , Pal , S . K . , L iu , J . , Zhang, G. , L iu , Y . , Wu, W. , Chen, W. and Sar ica , K . (2016) , Super-mini percutaneous nephrol i thotomy (SMP) : a new concept in technique and instrumentat ion. BJU Internat ional , 117: 655–661. doi : 10 .1111/bju.13242

6 Zanett i , S . et a l . Innovat ions in endourology: A c losed-c i rcuit vacuum-ass isted mini -PCNL system. European Urology Supplements . 17（2018）Volume 17. I ssue 8 . 263

7 Fontana, Matteo & Zanett i , Stefano & De Lorenzis , E l i sa & Lorusso, V & Morel l i , M & Sampogna, Gianluca & Luzzago, Stefano & Sabat ini , I & Gal l io l i , Andrea & Boer i , Luca & Palmisano, F & P iccol i , M & Albo, Giancar lo & Longo, F & Montanar i , Emanuele . (2019) . F i rst exper ience with vacuum-ass isted mini percutaneous nephrol i thotomy (vmPCNL) : Prel iminary results . European Urology Supplements . 18 . e22-e23. 10 .1016/S1569-9056(19)30017-X.

8 Zanett i , Stefano & Sampogna, Gianluca & Fontana, Matteo & De Lorenzis , E l i sa & Gal l io l i , Andrea & Lorusso, V & Morel l i , M & Boer i , Luca & Longo, F & Albo, Giancar lo & Montanar i , Emanuele . (2019) . Semi-c losed c i rcuit vacuum-ass isted mini -percutaneous nephrol i thotomy with holmium laser l i thotr ipsy . European Urology Supplements . 18 . e2247. 10 .1016/S1569-9056(19)31629-X.

9 Sampogna, Gianluca & Zanett i , Stefano & Berrett in i , A l f redo & Gnech, M & Gianantonio, Manzoni & Montanar i , Emanuele . (2019) . C losed-c i rcuit vacuum-ass ist -ed miniperc system for k idney stones in chi ldren: Our in i t ia l exper ience. European Urology Supplements . 18 . e575-e576.

10 Giust i G , P icc inel l i A , Taverna G, Benett i A , Pas ini L , Cor int i M, et a l . Miniperc? No, thank you! Eur Urol .2007;51:810–4.

11 Avai lable at : http ://www.shippertmedical .com/UserFi les/F i le/T imesaving.pdf . Accessed January 14, 2010.

R e f e r e n c e s

The ClearPetra Nephrostomy Sheath improves the stone clearance in percutaneous nephrolithotomy (PCNL) and lowers the incidence of complications.

Table 1 Compar ison of d i�erent procedures of PCNL

OR Time (min) Advantage

Easiest in stone fragments retrieval

Less invasive, less risk of bleeding

Least invasive and minimum risk of

bleeding

Least invasive, minimum bleeding,

shorter operating time, stones are removed using

suction

SMP[5-9] with modi�ed Sheaths with

Suction-Evacuation Function

Short coming

More invasive and higher risk of

bleeding

Stones are retrieved using pressurized irrigation or stone

forceps

Longer operating time. Stone are removed using pressurized

irrigation

PCNL[2]

MPCNL[3]

UMP[4]

Tractsize

30Fr

<18Fr

12-14Fr

12-14Fr

Visualization

good

+/-

+/-

good

Intra-luminalPressure

negative

+/-

+/-

negative

Egress of stonefragments

Active

Passive

Passive

Active

The ClearPetra Ureteral Access Sheath makes ureteroscopic lithotripsy (URS) simpler, safer, faster and cost e�ective.

Cost

Table 3 Compar ison of cost of URS

Please �l l in the cost and see how much the ClearPetra sheath can save!

Access Sheath

Stone Basket

Anti-retropulsion device

ClearPetra Sheath ONLY

Conventional URS

Instruments needed Cost

URS with ClearPetra Sheath

Instruments needed

The ClearPetra Nephrostomy Sheath saves cost by reducing the operating time.

Table 2 Compar ison of operat ing t ime of PCNL

OR Time (min)

155.5 +/- 32.9

45.6 (25 –115)

109.9

@ US$62

US$6,813.80

<2cm, MiniPerc[10]

2.2cm, SMP with ClearPetra[1]

Average OR Time Saving

Cost of OR per minute[11]

Approximate Average Cost Saving

Mean stone Size & Procedure

Address: 47 Guomao Avenue South, Panyu, Guangzhou, China

Tel: +86-20-84758878 Fax: +86-20-84758224 Post Code: 511434

www.welllead.com.cn www.clearpetra.com E-mail: clearpetra@welllead.com.cn

wl.clearpetra.v1.190413

C l e a r P e t r a U r e t e r a l A c c e s s S h e a t hID/OD×LengthCat. No. ID/OD×LengthCat. No. ID/OD×LengthCat. No.

ID/OD×LengthCat. No. ID/OD×LengthCat. No. ID/OD×LengthCat. No.

ID/OD×LengthCat. No. ID/OD×LengthCat. No. ID/OD×LengthCat. No.

90111013

90111026

90111036

90111040

90111046

90111055

90111113

90111126

90111136

90111140

10/12Fr × 13cm

10/12Fr × 26cm

10/12Fr × 36cm

10/12Fr × 40cm

10/12Fr × 46cm

10/12Fr × 55cm

11/13Fr × 13cm

11/13Fr × 26cm

11/13Fr × 36cm

11/13Fr × 40cm

90111146

90111155

90111213

90111226

90111236

90111240

90111246

90111255

90111313

90111326

11/13Fr × 46cm

11/13Fr × 55cm

12/14Fr × 13cm

12/14Fr × 26cm

12/14Fr × 36cm

12/14Fr × 40cm

12/14Fr × 46cm

12/14Fr × 55cm

13/15Fr × 13cm

13/15Fr × 26cm

90111336

90111340

90111346

90111355

90111413

90111426

90111436

90111440

90111446

90111455

13/15Fr × 36cm

13/15Fr × 40cm

13/15Fr × 46cm

13/15Fr × 55cm

14/16Fr × 13cm

14/16Fr × 26cm

14/16Fr × 36cm

14/16Fr × 40cm

14/16Fr × 46cm

14/16Fr× 55cm

C l e a r P e t r a N e p h r o s t o m y S h e a t h

90121013

90121015

90121017

90121021

90121213

90121215

90121217

90121221

90121413

90121415

90121417

90121421

10/12Fr×13cm

10/12Fr×15cm

10/12Fr×17cm

10/12Fr×21cm

12/14Fr×13cm

12/14Fr×15cm

12/14Fr×17cm

12/14Fr×21cm

14/16Fr×13cm

14/16Fr×15cm

14/16Fr×17cm

14/16Fr×21cm

90121613

90121615

90121617

90121621

90121813

90121815

90121817

90121821

90122013

90122015

90122017

90122021

16/18Fr×13cm

16/18Fr×15cm

16/18Fr×17cm

16/18Fr×21cm

18/20Fr×13cm

18/20Fr×15cm

18/20Fr×17cm

18/20Fr×21cm

20/22Fr×13cm

20/22Fr×15cm

20/22Fr×17cm

20/22Fr×21cm

90122213

90122215

90122217

90122221

90122413

90122415

90122417

90122421

90122613

90122615

90122617

90122621

22/24Fr×13cm

22/24Fr×15cm

22/24Fr×17cm

22/24Fr×21cm

24/26Fr×13cm

24/26Fr×15cm

24/26Fr×17cm

24/26Fr×21cm

26/28Fr×13cm

26/28Fr×15cm

26/28Fr×17cm

26/28Fr×21cm

C l e a r P e t r a C y s t o s c o p e S h e a t h

90131821

90131824

18/20Fr × 21cm

18/20Fr × 24cm

90132021

90132024

20/22Fr × 21cm

20/22Fr × 24cm

90132221

90132224

22/24Fr × 21cm

22/24Fr × 24cm

S t o n e C o l l e c t i o n B o t t l eSize (ml) Cat. No.

79880200

79880140

79880141

200ml for 10Fr-22Fr sheath

140ml for 10Fr-22Fr sheath

140ml for 24Fr and 26Fr Sheath