NAGELE Modular Minimally Invasive PCNL System Instruction Manual

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URO 47 5.5 07/2021-E A New Generation of Pressure-Controlled PCNL Systems

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URO 47 5.5 07/2021-E

A New Generation of Pressure-Controlled PCNL Systems

NAGELE Modular Minimally Invasive PCNL System

In recent years, the concept of minimally invasive percutaneous stone treatment (MIP) has become an accepted standard in miniaturized percutaneous surgery. This has been corroborated in numerous publications.

The key features of our system – single step dilation; automatic pressure control; stone extraction in the irrigation flow (= vacuum cleaner effect) and the possibility to close the access tract using a gelatin-thrombin matrix in conjunction with ultrasound-guided puncture of the kidney – allow atraumatic and effective stone treatment with fewer complications. The successful outcome of the firstgeneration MIP system created the incentive to meet future challenges in endourology and to switch to a new generation. The second generation of the modular MIP system features 4 instrument sizes to match various indications. This enables urologists to adapt the benefits of minimally invasive PCNL to individual stone sizes and choose the best possible lithotripsy option for each size.

“In an era where computed tomography is used to confirm stone-free status, the trend towards endourological stone treatment has become more firmly established. However, the initial euphoria surrounding the introduction of the third generation of flexible uretero-renoscopes has subsided due to limitations of use in routine urological practice. Percutaneous nephrolitholapaxy has proved superior in terms of stone-free rates with regard to the treatment of larger stone burdens and particularly in cases of unfavorable kidney geometry. It also presents an alternative for the treatment of small stones, particularly if the complication rate for the minimally invasive procedure is low but high for primary freedom from calculi.

NAGELE stone concept

Nephrolithiasis

renal pelvis middle and upper calyceal group

inferior calyceal group

≤ 8 mm

> 8 mm

> 15 mm

URS flexible

≥ 1000 HU: URS < 1000 HU: ESWL

MIP

Alternative to URS No access to kidney

MIP XS 9.5 Fr.

≤ 15 mm

8-15 mm

10-30 mm MIP

staghorn calculi and > 15 mm

stone size

MIP S 12 Fr.

MIP M 17.5 Fr.

MIP L 24 Fr.

procedure

Modular Minimally Invasive PCNL System

In contrast to larger nephroscopes, active irrigation is necessary (mandatory when using the XS system but optional for the S-system). Calculi dust following laser fragmentation is suctioned with the irrigation liquid through a ureter catheter. This represents a revolutionary approach in percutaneous stone removal.

The series of minimally invasive percutaneous instruments now available makes it possible to expand the spectrum of percutaneous stone treatment. This fills the treatment gap for narrow regions that were previously inaccessible for the flexible uretero-renoscope or for impassable calculi following ESWL treatment. In the case of multiple concretions in several calices or if endoscopy is required to control stone elimination, the L system enables the use of flexible nephroscopes.”

Prof. Dr. med. U. NAGELE, Landeskrankenhaus, Hall in Tirol, Austria

Contrary to the current trend of using superlatives (ultramini, micro, nano) to denote new PCNL systems, we decided to classify our nephroscopes according to various stone sizes: XS, S, M (previous size) and L. All instrument components associated with a specific nephroscope size bear a clearly visible marking to prevent incorrect use of automatic pressure control and the vacuum cleaner effect so that danger to patients is minimized. The most important innovations are: Enhanced hydrodynamics relative to each nephroscope size; modification of the sheaths via a larger working length for the treatment of adipose patients or patients in the supine position; and the field and angle of view relative to the nephroscope size.

Systematic presentation MIP XS

Irrigation liquid

Irrigation liquid through the sheath

Renal calculus Suction-irrigation pump

Adaptor

Catheter

Irrigation liquid through the sheath

The New Family of MIP Systems and Innovative Features Versatility The right instrument is available for every stone indication. The systems stand out due to their quality and durability.

One-step bougie Following a skin incision, a single dilator can widen the port to allow the sheath to be advanced into the kidney. Telescope bougies or bougies in several sizes are no longer required for individual sheath sizes.

Innovative pressure management

inflow outflow

outflow

Innovative pressure management with MIP XS Due to the small lumen of the MIP XS system, use of the UROMAT E.A.S.I.® pump is recommended for adequate fluid irrigation and suction.

inflow

outflow

All systems from the MIP series are designed as open systems, i.e. the sheath and telescope are not locked together and there is no second system connection to the system where irrigation liquid can flow off. With the MIP series, the irrigation liquid flows out via the space between the telescope and the operating sheath. Discontinuation of the outflow, which would lead to pressure build-up in the kidney, is not possible.

Efficient stone retrieval with the “vacuum cleaner effect” The hydrodynamic effect (“vacuum cleaner effect”) achieved by the innovative inflow and outflow constellation makes it possible to retrieve stones without grasping forceps or stone baskets. A continuous irrigation flow also enables the residuefree elimination of small stone fragments and calculus dust.

outflow Abfluss inflow Zufluss outflow Abfluss

Direct closure of the access tract Access tracts to the kidney can be directly closed after stone retrieval using a gelatin-thrombin matrix. This eliminates the need for nephrostomy (kidney fistula) in standard PCNL access tracts.

Longer sheaths for the “supine technique”

To meet the needs of the emerging market trend for the “supine technique”, KARL STORZ now offers dedicated “supine sheaths” for all MIP systems for the first time. As the supine sheaths can be used with standard telescopes, this offers the user a flexible, yet cost-effective solution.

Use in pediatric applications The MIP system ensures that both adult and pediatric patients benefit from atraumatic treatment thanks to the small sheath diameter in combination with a low-pressure system.

MIP L – Percutaneous Nephroscope

Special Features:

Specifications:

• Open system allows atraumatic therapy under low-pressure conditions

Instrument sheath: 19.5 Fr. Working channel: 12.4 Fr. for use with instruments up to 11.5 Fr. Telescope: HOPKINS® rod lens telescope Direction of view 12º Length: 22 cm Eyepiece: angled

• One step dilator with a second eccentric channel allows the placement of another guide wire • Large working channel allows the use of rigid standard instruments and lithotripsy probes up to 11.5 Fr. • “Vacuum cleaner effect”

27840KAK

Nephroscope for MIP L, autoclavable

27840GP

Instrument Port with Sealing System and Quick Release Lock, 1 channel

27500

LUER-Lock Tube Connector, male, tube diameter 9 mm

27502

LUER-Lock Tube Connector, with stopcock, dismantling

27001E

Insertion Aid, for guide wires

30160XA

Silicone Leaflet Washer, diameter 3-5.5 mm, type dome valve, package of 10

30160XB

Seal, package of 10

39501XKL

Wire Tray including: Cleaning Adaptor, for Instrument Port 27840GP

The following accessories are included in delivery:

Dilators, Sheaths and Applicators

for MIP L

27840AA

One Step Dilator, 23/24 Fr., with central channel and a second eccentric channel for guide wires, for use with 23/24 Fr. Operating Sheaths 27840BA/27840BAS

27840AB

Same, 25/26 Fr., for use with 25/26 Fr. Operating Sheaths 27840BB/27840BBS

27840BA

Operating Sheath, 23/24 Fr., working length 15 cm, for continuous irrigation and suction

27840BB

Same, 25/26 Fr.

27840BAS

Operating Sheath, for the supine position, 23/24 Fr., working length 18 cm, for continuous irrigation and suction

27840BBS

Same, 25/26 Fr.

27840CF

Applicator for Sealant, including sheath and rod, for use with Operating Sheaths 27840BA/27840BB

27840CFS

Applicator for Sealant, for the supine position, including sheath and rod, for use with Operating Sheaths 27840BAS/27840BBS

MIP M – Percutaneous Nephroscope

Special Features: • One step dilator with a second eccentric channel allows the placement of another guide wire • Large working channel allows the use of rigid standard instruments and large lithotripsy probes up to 5 Fr. • “Vacuum cleaner effect”

Specifications: Instrument sheath: 12 Fr. Working channel: 6.7 Fr. for use with instruments up to 5 Fr. Telescope: Fiber optic system Direction of view 12º Length: 22 cm Eyepiece: angled

Telescope Working/irrigation channel

27830KAK

Nephroscope for MIP M, autoclavable

27001GP

Instrument Port with Sealing System and Quick Release Lock, 1 channel

27550N

Seal, for Instrument Ports 27001G, 27001GF, 27001GH, 27001GP, package of 10, single use recommended

27500

LUER-Lock Tube Connector, male, tube diameter 9 mm

27502

LUER-Lock Tube Connector, with stopcock, dismantling

27001E

Insertion Aid, for guide wires

39501XK

Wire Tray including: Cleaning Adaptor, for Instrument Ports 27001G/27001GF/27001GH/27001GG

The following accessories are included in delivery:

Dilators, Sheaths and Applicators

for MIP M

27830AA

One Step Dilator, with central channel for guide wires, for use with 15/16 Fr. Operating Sheaths 27830BA/27830BAS

27830AB

One Step Dilator, with central channel and a second eccentric channel for guide wires, for use with 16.5/19.5 Fr. Operating Sheaths 27830BB/27830BBS

27830AC

One Step Dilator, with central channel for guide wires and distal curved channel for deflection of guide wires, for use with 21/22 Fr. Operating Sheaths 27830BC/27830BCS

27830BA

Operating Sheath, 15/16 Fr., working length 15 cm, for continuous irrigation and suction

27830BB

Same, 16.5/17.5 Fr.

27830BC

Same, 21/22 Fr.

27830BAS

Operating Sheath, for the supine position, 15/16 Fr., working length 18 cm, for continuous irrigation and suction

27830BBS

Same, 16.5/17.5 Fr.

27830BCS

Same, 21/22 Fr.

27830BK

Operating Sheath for Children, 16.5/17.5 Fr., working length 7.5 cm, for continuous irrigation and suction

27830CF

Applicator for Sealant, including sheath and rod, for use with Operating Sheaths 27830BA/27830BB/27830BC

27830CFS

Applicator for Sealant, for the supine position, including sheath and rod, for use with Operating Sheaths 27830BAS/27830BBS/27830BCS

27001GG

Instrument Port with Sealing System and Quick Release Lock, large, 1 channel, for use with accessories up to 6 Fr. (diameter 2 mm) in combination with Nephroscope for MIP M 27830KA

Optional Accessories

27840LIK

LASER Hand Instrument, distal tip bent upwards, fixation for LASER fibers and sealing system, working length 35 cm, for use with Nephroscope for MIP L 27840KA and Instrument Port MIP L 27840GP as well as LASER fibers up to diameter 1 mm including: Cleaning Adaptor Seal, package of 10

27290F

Forceps, for grasping stone fragments and coagula, with fenestrated jaws and U-spring handle, 11.5 Fr., length 38 cm, color code: red-black

27290H

Forceps, for grasping larger stones and stone fragments, with triple serrated jaws and U-spring handle, 10.5 Fr., length 38 cm, color code: red-black

27290K

Forceps, for grasping larger stones and stone fragments, with fenestrated jaws and ring handle, double action jaws, 10.5 Fr., length 38 cm, color code: red-black

27290M

Forceps, for grasping larger stones and stone fragments, with serrated jaws and ring handle, double action jaws, 10.5 Fr., length 38 cm, color code: red-black

27294S

Knife, straight, with 3-ring handle, 10.5 Fr., length 38 cm, color code: red-black

27294SK

Knife, only

27294SH

Knife, sickle-shaped, with 3-ring handle, 10.5 Fr., length 38 cm, color code: red-black

27294SB

Knife, only

27840DS

Seal, for Instrument Port 27840GP, bore 0.7 mm, package of 10, for use with thin lithotripsy probes

for MIP L

Optional Accessories for MIP M

Forceps for Foreign Body Removal, double action jaws, flexible, 5 Fr., length 40 cm

27830FL

Biopsy Forceps, double action jaws, flexible, 5 Fr., length 40 cm

27830S

Scissors, single action jaws, semiflexible, 5 Fr., working length 40 cm

27830H

Forceps, rigid, for grasping large stones and stone fragments, with triple serrated jaw parts and U-spring handle, 5 Fr., length 36 cm

27830FK

MIP XS/S – Percutaneous Nephroscope Special Features:

Specifications:

• Smallest system in the MIP family

Instrument sheath: 7.5 Fr. Working channel: 2 Fr. Separate irrigation channel: 3 Fr. Telescope: Fiber optic system 6º Direction of view Length: 24 cm angled Eyepiece:

• Working channel with 2 Fr. for guided laser fibers • Separate irrigation channel • Provides an alternative where flexible ureterorenoscopy is not possible

Telescope

Working channel Irrigation channel

27820KAK

Nephroscope for MIP XS/S, autoclavable

27001G

Instrument Port with Sealing System and Quick Release Lock, 1 channel

27550N

Seal, for Instrument Ports 27001G, 27001GF, 27001GH, 27001GP, package of 10, single use recommended

27500

LUER-Lock Tube Connector, male, tube diameter 9 mm

27502

LUER-Lock Tube Connector, with stopcock, dismantling

27001E

Insertion Aid, for guide probes

39501XK

Wire Tray including: Cleaning Adaptor, for Instrument Ports 27001G/27001GF/27001GH/27001GG

39501XRV

Multiport Bridge

39107ALK

Cleaning Adaptor, for use with small LUER stopcocks

The following accessories are included in delivery:

Dilators, Sheaths and Applicators for MIP XS/S Dilator and operating sheaths for MIP XS

27820AA

One Step Dilator, with central channel for guide wires, for use with 8.5/9.5 Fr. Operating Sheaths 27820BA/27820BAS

27820BA

Operating Sheath, 8.5/9.5 Fr., working length 15 cm

27820BAS

Operating Sheath, for the supine position, 8.5/9.5 Fr., working length 18 cm

Dilator and operating sheaths for MIP S

27820AB

One Step Dilator, with central channel for guide wires, for use with 11/12 Fr. Operating Sheaths 27820BB/27820BBS

27820BB

Operating Sheath, 11/12 Fr., working length 15 cm, for continuous irrigation and suction

27820BBS

Operating Sheath, for the supine position, 11/12 Fr., working length 18 cm, for continuous irrigation and suction

27820BK

Operating Sheath for Children, 11/12 Fr., working length 7.5 cm, for continuous irrigation and suction

Applicator for MIP XS/S

27820CF

Applicator for Sealant, including sheath and rod, for use with Operating Sheaths 27820BA/27820BB

27820CFS

Applicator for Sealant, for the supine position, including sheath and rod, for use with Operating Sheaths 27820BAS/27820BBS

UROMAT E.A.S.I.® SCB System Components for MIP XS

UNIT SIDE PATIENT SIDE

Irrigation Tubing Set

031717-10*

Nephroscope for MIP XS/S

* 16

Operating Sheath, 8.5/9.5 Fr., use of UROMAT E.A.S.I.® SCB mandatory

Suction Tubing Set

27820BA

031217-10*

27820KAK

UROMAT E.A.S.I.® SCB Pressure-regulated suction and irrigation system Special Features: •

•

Innovative: Intelligent, pressure-regulated double roller pump (ensures a constant balance between inflow and outflow) Cost-efficient: Continuous comparison of pressure and flow values enables optimal fluid use Convenient: Preset parameters for endo-urological applications Intuitive: Pump parameters can be selected via touch screen

UP410S1

•

Market-oriented: BOLUS function with adjustable parameters which can be activated via footswitch or touch screen Easier identification: Color coding of the tubing set Blue: Irrigation Red: Suction Can be used for all indications in urology

UROMAT E.A.S.I.® SCB, power supply 100 – 240 VAC, 50/60 Hz, UROMAT E.A.S.I.®: SCB ready, compatible from RUI Release 45 including: SCB Connecting Cable, length 100 cm Basic Tubing Set*, for single use Control Cable

Accessories: 031717-10* Irrigation Tubing Set, with two puncture needles, sterile, for single use, package of 10, for use with HYSTEROMAT E.A.S.I.® and UROMAT E.A.S.I.® SCB 031217-10* Suction Tubing Set, sterile, for single use, package of 10, for use with HYSTEROMAT E.A.S.I.® and UROMAT E.A.S.I.® SCB

Specifications Irrigation flow

depending on mode

Irrigation pressure

adjustable 20-200 mmHg

Suction Power supply

Dimensions wxhxd

447 x 155 x 313 mm

100-1800 ml/min suction power

Weight

8.8 kg

100-240 VAC, 50/60 Hz

Certified to

IEC 60601-1, CE acc. to MDD

* 17

Notes

It is recommended to check the suitability of the product for the intended procedure prior to use. Please note that the described products in this medium may not be available yet in all countries due to different regulatory requirements.

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Applicator For Sealant

NAGELE Modular Minimally Invasive PCNL System Instruction Manual