Automated surgical suture systems · Suture packaging Thread & needle assembly Suture winding TCM...

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Automated surgical suture systems

Transcript of Automated surgical suture systems · Suture packaging Thread & needle assembly Suture winding TCM...

Page 1: Automated surgical suture systems · Suture packaging Thread & needle assembly Suture winding TCM automatic surgical suture thread cutting machine The TCM machine is designed to precisely

Automated surgical suture systems

Page 2: Automated surgical suture systems · Suture packaging Thread & needle assembly Suture winding TCM automatic surgical suture thread cutting machine The TCM machine is designed to precisely

In addition to our vast experience in the automation of complex processes and the realisation of Sysmelec® custom designed machines, we have an extensive know-how in the medical industry. These skills allowed our highly qualified specialists to conceive a range of standard automated surgical suture systems, such as:

> TCM automatic surgical suture thread cutting machine

> SCM automatic surgical suture crimping machines

> WIND automatic surgical suture winding machines

The product range provides the perfect turnkey solutions from the industrial automatic thread cutting to the surgical suture final packaging operations.

Turnkey standard automated systems

Crimping Pull testSuture

unloadingThread cutting

& stiffeningThread & needle

loadingSuture packagingThread & needle

assemblySuture

winding

TCM automatic surgical suture thread cutting machine

The TCM machine is designed to precisely cut a broad range of surgical suture threads.

Before being precisely cut to the chosen length, the multifilament thread is stiffened thanks to an adjustable thermal process.

The cut threads are unloaded in containers/bins made of stainless steel, ready for the assembly process with the needle either by hand or via the fully automated SCM suture crimping machine Sysmelec®.

Range of suture machines in brief

Sysmelec® automated systems have successfully been deployed in a wide variety of medical device applications, such as:

- Endoscopes i.e. wire thread shaping, precise cutting, attaching, assembly

- Sensors i.e. wire unwinding, vision guided positioning, welding on pin

- Implants i.e. radioactive material dispensing, laser soldering for sealing

- Metal inserts i.e. metal wire 3D shaping, cutting, assembly, gluing

- PTFE tube i.e. precise cutting, sharp edge, thermoforming, assembly

Medical applications expertise

SCM automatic surgical suture crimping machines

The SCM machines are dedicated to the assembly and crimping of multivariant surgical sutures.

A wide range of needles and threads can be handled and a fast product changeover time allows the production of large and small batches.

Every suture is 100% tensile force tested to guarantee a constant and high quality thread-needle combination. The finished product is unloaded in stainless steel containers or transferred to the automated WIND winding machine Sysmelec®.

WIND automatic surgical suture winding machines

The WIND machines are dedicated to the winding of surgical sutures into cardboard.

The developed Sysmelec® cardboard design guarantees a safe needle fixation and a proper folding/closing of the cardboard packaging.

The surgical suture packaging is automatically unloaded into bulk or into customised magazines.

Thanks to a full infrastructure in our cleanroom and test laboratory, practical validation can be carried out on test benches or on a prototype if specific tools are required.

Furthermore, a production pilot can be realised if the processes must be tested over several weeks or months in similar conditions as the production environment.

Full infrastructure

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overview

Page 3: Automated surgical suture systems · Suture packaging Thread & needle assembly Suture winding TCM automatic surgical suture thread cutting machine The TCM machine is designed to precisely

The TCM automatic surgical suture thread cutting machine Sysmelec® provides a fast and efficient way for the automatic thread length cutting including the multifilament stiffening.

The integrated adjustable thermal process for multifilament thread stiffening allows a constant high quality by using state of the art numerical controllers for process supervision.

A wide range of different thread types can be precisely cut to a defined length.

Advantages of TCM automatic surgical suture thread cutting machine

Thread length 350 mm to 900 mm*

Thread diameter USP 6/0 to USP 2 (EP 0.7 to EP 5)*

Electronic control Industrial PC

Air pressure requirements 6 bar / Class 5 /

Power requirements 3x 400 VAC / 50/60 Hz

TCM machine dimensions 2’800 x 1’450 x 2’450 mm (LxWxH)

Product changeover time less than 5 minutes

Typical throughput 500 / 1’100 / 1’650 products/hour (depending on the number of installed thread coils)

TCM performances & technical specifications

Mode Teaching programming

Thread length precision < 1%

Programming Dialogue menu HMI using screen and keyboard or hand console

Noise level < 75 dBA

Control voltage 24 VDC

TCM machine weight ~1’100 kg

Threads Monofilament & multifilament / PA, PP, PGA, PVDF, PE*

Instant cycle time 6.5 - 7.0 seconds (including stiffening process)

Conformity CE Conformity

TCM detailed process sequence

Loading of the thread

The monofilament or multifilament thread is loaded from a coil by means of a numerical linear axis. During the entire coil unwinding operation, a small constant force is applied to the thread in order to guarantee a consistent length.

Stiffening of the multifilament thread

Before being precisely cut to the chosen length, the multifilament thread is stiffened by means of an adjustable thermal process. The system is composed of a special designed heating source which heats the thread. The heating unit is mounted on a numerical axis ensuring very precise and constant heating time. The temperature parameters can be adjusted.

Cutting of the thread

The thread is cut by two blades, made of hard metal, into a dedicated angle to get an optimal insertion of the thread into the needle bore hole later on. During the cutting operation, the thread is held into position by two grippers.

Unloading of the thread

The thread is unloaded in one or more receptacles. The unused receptacle allows unloading without machine or process interruption.

Options

> Automatic thread knot detection

> Cutting of stiffened thread ends

> Upgradeable to have two, three or even more thread coils processed in parallel

*Other thread materials, lengths or diameters might be used as well upon request.

TCM machine layout

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thread cutting

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SCM100 machine - NEW GENERATION

The SCM100 automatic surgical suture crimping machine Sysmelec® was designed years ago and is dedicated to the industrial assembly of surgical sutures.

Well established on the market and with its capabilities since its introduction, the SCM100 machine has now been re-designed and further optimised and improved – a new generation is born!

Advantages of SCM automatic surgical suture crimping machines

Advantages for both SCM100 & SCM200 machines

A very stable quality during the whole production is guaranteed. After the crimping of the needle, the quality of all sutures is checked through a pull test.

An efficient and cost effective production is guaranteed, being able to run multi-shifts up to 24/7.

These machines are standalone and generate continuously a product to completion. The loading of the needle into bulk and the unloading of the finished product can be carried out without stopping the machine. Only the coil has to be changed manually.

Despite a high degree of automation, both machines are very flexible and suitable for small and large production batches of multivariant surgical sutures.

The handling of a large range of products with a very short changeover time between products is guaranteed.

Sysmelec® automatic crimping machines allow getting tested and functional high-quality surgical sutures!

NEW SCM200 machine - double capacity/speed

The SCM200 automatic surgical suture crimping machine Sysmelec® is the answer to the market’s demand for faster and more economical machines, whilst maintaining a high flexibility and quality.

SCM100/200 detailed process sequence

The SCM100/200 machines are based on a transfer system with two belt conveyors.

The distance between both of them is manually adjustable for the required lengths of thread.

Loading of the thread

Loading of the thread from a coil by means of a numerical linear axis onto the transfer system.

During the entire coil unwinding operation, a small constant force is applied to the thread in order to guarantee a consistent length.

Stiffening of the thread

Before being precisely cut to the chosen length, the multifilament thread is stiffened by means of an adjustable thermal process.

The system is composed of a special designed heating source which heats the thread.

The heating unit is mounted on a numerical axis ensuring very precise and constant heating time. The temperature parameters can be adjusted.

Cutting of the thread

The thread is cut by two blades, made of hard metal, into a dedicated angle to get an optimal insertion of the thread into the needle bore hole later on.

During the cutting operation, the thread is held into position by two grippers.

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suture crimping

Page 5: Automated surgical suture systems · Suture packaging Thread & needle assembly Suture winding TCM automatic surgical suture thread cutting machine The TCM machine is designed to precisely

Loading of the needle

Automatic separation and loading of the needle.

A vision system identifies the position and orientation of the needles on a picking plate and drives a XYZ-theta robot to grip one of them. If no needle is available on the picking plate, the storage container automatically vibrates to move the needles forward.

The storage container can be refilled during the operation enabling the machine’s continuous performance.

The gripped needle is then brought to the thread end. The precise adjustment of the drilled needle hole to the thread end is performed under the control of a vision system.

Crimping of the thread into the needle

After a first crimping, the crimping tool opens while the needle is rotated in order to be crimped a second time.

The specific crimping forces, as well as the number of crimping operations, can be freely configured. The crimping tools are prevalent on the market.

Pull test for quality check

Once the crimping process is complete, a pull test to check the quality is performed.

A gripper, mounted on a numerical axis, holds the thread and pulls the suture until the maximum required force (1-20N) is reached.

All data regarding lot material, crimping and testing forces are stored in logfiles for traceability and statistical evaluation purposes.

Unloading of the product

Unloading of the product in two stainless steel receptacles. The second receptacle allows unloading without machine or process interruption.

Options

> Automatic thread knot detection> Automatic crimping tool cleaning> Destructive test station (20 N to 80 N) with force sensor> Automatic transfer to our winding machine

SCM100/200 detailed process sequence

Thread diameter USP 6/0 to USP 2 (EP 0.7 to EP 5)*

Needles D- & H-types (3/8 & 1/2) / 10 mm to 48 mm (arc length)*

Electronic control Industrial PC

Air pressure requirements 6 bar / Class 5 /

Power requirements 3x 400 VAC / 50/60 Hz / Pre-fuse 16A

SCM machine dimensions 2’800 x 2’200 x 2’350 mm (LxWxH) 4’200 x 2’200 x 2’350 mm (LxWxH)

Product changeover time less than 10 minutes

Typical throughput 500 products/hour 1’000 products/hour

SCM machine performances & technical specifications

Mode Teaching programming

Thread length 350 mm to 900 mm*

Threads Monofilament & multifilament / PA, PP, PGA, PVDF, PE*

Programming Dialogue menu HMI using screen and keyboard or hand console

Noise level < 75 dBA

Control voltage 24 VDC

SCM machine weight ~1’750 kg

Sutures One armed suture with drilled end needles

Instant cycle time 6.5 - 8.0 seconds 3.3 - 4.3 seconds

Conformity CE Conformity

SCM100 SCM200 (double capacity/speed)

Autonomy 2’000 finished products 4’000 finished products

Needle design R = Round-bodied, S = cutting, etc.*

Thread length precision <1% of the thread’s length

SCM100 machine layout

*Other needle shapes, needle lengths, thread materials, thread diameters, thread lengths and coatings might be used as well upon request.

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suture crimping

Page 6: Automated surgical suture systems · Suture packaging Thread & needle assembly Suture winding TCM automatic surgical suture thread cutting machine The TCM machine is designed to precisely

The WIND100 & WIND200 (double speed) automatic surgical suture winding machines Sysmelec® allow a safe and problem free winding of surgical sutures thanks to a controlled force and velocity into the cardboard, thus guaranteeing a constant quality.

The pre-programmed suture receipts and winding parameters can by easily selected from the powerful function library via the HMI.

Sysmelec® own developed cardboards are optimised for the automatic winding and folding processes and set new standards in regards to customised graphic designs.

The winding machine is very flexible and capable of winding different thread types and diameters as well as different needle sizes and shapes, whilst maintaining a high degree of automation.

Advantages of WIND automatic surgical suture winding machines

Thread diameter USP 6/0 to USP 2 (EP 0.7 to EP 5)*

Needles D- & H-types (3/8 & 1/2) / 10 mm to 48 mm (arc length)*

Electronic control Industrial PC

Air pressure requirements 6 bar / Class 5 / ISO 8573.1

Power requirements 3x 400 VAC / 50/60 Hz / Pre-fuse 16A

Machine dimensions 1’400 x 1’450 x 2’450 mm (LxWxH) 2’800 x 1’450 x 2’450 mm (LxWxH)

Product changeover times less than 10 minutesTypical throughput 500 products/hour 1’000 products/hour

WIND machine performances & technical specifications

Mode Teaching programming

Thread length 320 mm to 1’200 mm*

Threads Monofilament & multifilament / PA, PP, PGA, PVDF, PE, Silk, Catgut*

Programming Dialogue menu HMI using screen and keyboard or hand console

Noise level < 75 dBA

Control voltage 24 VDC

Machine weight ~800 kg

Sutures One armed suture with drilled end needles

Instant cycle time 6.5 - 8.0 seconds 3.3 - 4.3 seconds

Conformity CE Conformity

WIND100 WIND200 (double capacity/speed)

Loading of the cardboard

The empty cardboard is automatically loaded from a stack or a magazine onto a custom designed working platforms.

Fixing of the suture needle

The suture needle is fixed on Sysmelec® own cardboard using a fully programmable linear axis and is maintained into position during the winding operation.

Winding of the suture thread

The suture thread (multifilament or monofilament) is winded as circle or eight shape into the cardboard using a fully programmable robot. The winding process parameters can be adjusted, allowing different winding speeds and thread tensions.

Folding of the cardboard

The cardboard is automatically folded using pneumatic systems which are integrated on the working platform.

Unloading of the cardboard

The finished folded cardboard packaging is automatically unloaded into bulk or customised magazines.

Options> Integration of cardboard printing systems> Full product traceability by integrating barcode scanner/reader> Quality check of the finished product, using a state of the art vision system> Automatic connection/interface to our suture crimping machine

WIND100/200 detailed process sequence

*Other needle shapes, needle lengths, thread materials, thread diameters, thread lengths and coatings might be used as well upon request.

WIND100 machine layout

Product changeover times less than 10 minutes

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suture winding

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Sysmelec® Unitechnologies SA Bernstrasse 5 CH-3238 Gals Switzerland T +41 32 338 80 80 F +41 32 338 80 99 [email protected] www.sysmelec.ch

The art of precision