MDR certified Bendable Tip and Negative Evacuation Flexible Ureteral Access Sheath

Beside the main channel for ureteroscope and liquid irrigation, Y-Shape negative suction access sheath adds a bypass channel to reduce the visual interference and facilitate the stone discharging, together with the external negative pressure suction mechanism. They acquired MDR (CE) certificate by TuV and the company acquired the IAF accredited ISO 13485 certificate.
The distal end of the sheath tube is bendable, it will bend together with the ureteroscope to reach different kidney calices in deeper location of the renal pelvis.
Working principle: In urological surgery, especially urology ureteroscopy for kidney stone surgery or diagnosis, the access guide sheath is used in combination with the dilators. After entering the urinary tract under the guidance of B-ultrasound or X-ray, the dilator is withdrawn and the guide sheath is left in place to establish and maintain the passage for endoscope and other instruments to enter the urinary tract.
Scope of application: Disposable negative suction ureteral access sheath is used to establish tract/passage for endoscope and other instruments to enter the urinary tract during urological surgery.
Applicable population: It is suitable for patients who need to establish tract/passage for endoscope and other instruments to enter the urinary tract.
Product Detail


Disposable Ureteral Access Sheath consists of access sheath and dilator tube.


The access sheath tube consists of access sheath tube body and access sheath joint. The surface of access sheath tube is coated with polyvidone (PVP). The dilator tube consists of dilator tube body and dilator tube connector. The access sheath tube body is made from nylon (PA), stainless steel and polytetrafluoroethylene (PTFE). The access sheath joint is made from polycarbonate (PC),  acrylonitrile-butadiene-styrene copolymer (ABS) and silicone. The dilator tube body and dilator tube connector is made from PE.

In urological surgery, the device is used in combination with the dilator tube. After entering the urinary tract under the guidance of B-ultrasound or X-ray, the dilator tube is withdrawn and the access sheath is left in place to establish and maintain the passage for endoscope and other instruments to enter the urinary tract.


The bybass channel in the photo below is the negative suction port that should be connected to a suction pump or irrigation pump, this smal innovation to the uerteral access sheath improves the urology surgery reliability greately.


Intended clinical benefits

· Simplified and rapid entry and re-entry into the ureter and collecting system;

· Decreased renal pressure that prevents pyelovenous backflow;

· Enhanced visibility and improved clearance of small stone fragments.


 Features:

---Silicone sealing ring, prevent the liquid leakage.

---Printed calibration for depth control.

---Air ventilation Slot to regulate the pressure.

---Bypass channel for stones and liquid drainage.

---The distal tip of W type sheaths are bendable, it could access renal pelvis and calices together with the flexible ureteroscope for searching and fragmentating stones in deeper position.

---Fragmenting and discharging the stones synchronously to reduce the dust residual.

--- CE MDR certified by TuV,  IAF accredited ISO 13485 certificate.


Ordering Information:

No.

Model

Description

ID/OD(Fr)

Length (cm)

1

205Z10F35

Z type

Straight joint access sheath

10/12

35

2

205Z10F45

45

3

205Z11F35

11/13

35

4

205Z11F45

45

5

205Z12F35

12/14

35

6

205Z12F45

45

7

205Z13F35

13/15

35

8

205Z13F45

45

9

205Z14F35

14/16

35

10

205Z14F45

45

11

205Y10F35

Y type negative suction Y joint access sheath

 

10/12

35

12

205Y10F45

45

13

205Y11F35

11/13

35

14

205Y11F45

45

15

205Y12F35

12/14

35

16

205Y12F45

45

17

205Y13F35

13/15

35

18

205Y13F45

45

19

205Y14F35

14/16

35

20

205Y14F45

45

21

205W10F40

W type negative suction Y joint access sheath

10/12

40

22

205W10F50

50

23

205W11F40

11/13

40

24

205W11F50

50

25

205W12F40

12/14

40

26

205W12F50

50

27

205W13F40

13/15

40

28

205W13F50

50

29

205W14F40

14/16

40

30

205W14F50

50

31

205T10F35

T type

Straight joint access sheath

10/12

35

32

205T10F45

45

33

205T11F35

11/13

35

34

205T11F45

45

35

205T12F35

12/14

35

36

205T12F45

45

37

205T13F35

13/15

35

38

205T13F45

45

39

205T14F35

14/16

35

40

205T14F45

45

41

205C10F35

C type negative suction W joint access sheath

 

10/12

35

42

205C10F45

45

43

205C11F35

11/13

35

44

205C11F45

45

45

205C12F35

12/14

35

46

205C12F45

45

47

205C13F35

13/15

35

48

205C13F45

45

49

205C14F35

14/16

35

50

205C14F45

45


Real Video Under Negative suction pressure @ 2000Pa: