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CMF surgery - Resorbable osteosynthesis SonicWeld Rx

Craniomaxillofacial Surgery

SonicWeld Rx®

SonicWeld Rx® is a revolutionary technique for use in craniomaxillofacial osteosynthesis. It combines highly advanced ultrasound technology with resorbable implants to provide extremely stable fixation and completely eliminate the need for a second operation.

 

The procedure is simple: resorbable meshes, plates or membranes are heated up, shaped to fit the application site and then fixed in place with SonicPins Rx® inserted into predrilled holes. This is done with a sonotrode that liquefies the pins, thus causing them to bond with the meshes, plates or membranes and penetrate into the bone cavities to anchor themselves securely. 

This procedure is not only clinically proven and validated, but also impresses with its patient-friendliness. The implants are hydrolytically degraded in a controlled manner. SonicWeld Rx® is primarily stable, easy and practical to use, fast and safe. It is ideally suited for anchorage in the cranial region and represents the ideal indication for pediatric trauma patients and cancellous bone structures.

Indications

The Resorb x implant system by Gebrüder Martin is intended for surgical procedures which require internal fixation by absorbable implants for aligning, reconstructing and stabilizing bone tissue. For example:

  • Osteosynthesis in non-load-bearing craniomaxillofacial areas
  • Craniofacial corrective osteotomies (e.g. syndrome patients, fronto-orbital advancement) in the non-load-bearing craniomaxillofacial area
  • Pediatric neurosurgery
  • Pre-prosthetic augmentation

Polymers

Resorbable polymers

Our resorbable polymers PDLLA and PLLA-PGA, have been well-established in craniomaxillofacial surgery.

  • Resorb x polymer is a 100% Poly-D,L-Lactic Acid (PDLLA).
  • Resorb xG polymer consists of 85% Poly-L-Lactic Acid (PLLA) and 15% Poly Glycolic Acid (PGA).

Both resorbables maintain the majority of their strength for 8-10 weeks, allowing complete fracture healing and bone regeneration.

The core of the degradation process: The complex polymer chains absorb the water contents (H2O molecules) of surrounding body fluids through a process called “hydrolysis”. The stored water initiates the degradation process by continuously breaking down the long polymer chains into ever shorter structures or simpler molecules. Metabolic pathways subsequently transform the molecules into carbon dioxide and water; both of these compounds are discharged naturally.

Implants

Each of our resorbable implants is manufactured under clean room conditions and only packaged after 100% visual inspection. This is how we ensure the highest patient safety.

Before delivery, all resorbable implants are gamma-sterilized, which is why they are always ready for immediate use intraoperatively.

The materials (Resorb x and Resorb xG) are compatible and can therefore be freely combined as desired. This allows you to offer each patient the best possible and individually tailored treatment.

SonicPin Rx®

Features:

  • Optimized pin geometry guarantees easy insertion of the pins into the bone structure together with best anchoring
  • Time-consuming tapping is eliminated completely
  • Self-retaining pin head on the sonotrode tip

Benefits:

  • Extremely simple, intuitive application
  • No dislocation of the bone fragments, no shearing of screw heads!
  • Maximum anchorage in the bony cavities of the trabecular structure
  • No unwanted falling off from the sonotrode tip

Resorb x and Resorb xG implants

Features:

  • Huge variety of different geometries, sizes and thicknesses
  • Membranes and foils in minimum diameters of 0.1 – 0.3 mm 
  • Osteosynthesis plates and meshes in 0.6 – 1.5 mm
  • Round corner geometry
  • Partly already 3D pre-bent

Benefits:

  • Always the ideal implant for every application
  • Round corner geometry guarantees best tissue compatibility
  • Best contourability after heating in the Xcelsior water bath

Surgical Techniques

Craniofacial corrective osteotomy

Midfacial fractures

Endobrow technique

Accessories

Xcelsior water bath

The Xcelsior water bath is used to warm resorbable implants (plates, meshes and membranes; e.g. Resorb x) or other thermoplastic materials (e.g. marPOR) from the KLS Martin Group in sterile surgical operations. This warming process allows the materials to be shaped to each patient’s specific anatomy.

Features: 

  • Preheating of Resorb x implants under the influence of heat 
  • Sterile liquid acts as heating medium 
  • Sterilizable cover and hood for working close to the patient in the operating field 
  • Extremely simple, intuitive application 

Benefits: 

  • Best contourability of the implants for seamless adaptation to the existing bone surface 
  • Cooled, the resorbable implants remain three-dimensionally stable 
  • High efficiency, even for large-area of stronger implants 
  • The risk of maloperation is largely excluded 
  • Environment-friendly - durable, reliable and safe working with the Xcelsior 

BOS Drill

The battery-powered BOS drill provides a comprehensive flexible and universally applicable drilling system. Drilling is performed within seconds (torque up to approx. 0.7 Nm). Time-consuming recharging or maintenance of the batteries is eliminated with the single-use sterile battery pack, which is clicked into place immediately prior to intraoperative use, ensuring consistent and lasting performance in any OR. 

Templates

Single-use aluminum templates allow the user to manually define the contour of the bone surface which can later be applied to the implant. This way, the use of implants that do not fit and frequent remodeling can be avoided. 

FAQs

1. Is the ultrasonic harming the bone structure due to the developing heat?

During “welding” there is a maximum rise in temperature of circa 11 °C (51.8 °F). This “heat” is only developed in seconds and therefore leaves no long-term harm to the bone structures due to necrosis.

2. Is pin extraction possible?

No, as the pin “melts” into a bone hole and becomes a union with the plate a removal of the pin is not possible. In cases of wrongly positioned pins resulting in unstable plate fixation it is possible to drill another hole over the initial position of the pin and insert an extra pin. Both SonicPins Rx® pins will resorb eventually. 

3. Are all dimensions and sizes of plates / meshes compatible with the entire range of SonicPins Rx?

Yes. SonicPins Rx® are available in 1.6 mm and 2.1 mm diameter and are compatible with all Resorb x and xG plates, meshes and membranes independent of their sizes and plate profiles. They can be combined freely.  

4. How long do I leave the plate in the water bath in order to be able to shape it?

We recommend a heating for 15-30 seconds in a temperature between 70–90 °C (158–194 °F). This can be repeated three times per plate.

5. Is it a proof for a completely resorbed implants, when I cannot see the resorbable implant in X-Rays anymore?

No. Our material cannot be seen in X-Rays. It is "translucent". Therefore, a missing implant in the scans is no proof for an absorbed implant.  

6. Can I scan patients in the MRI when they have a resorbable implant?

Yes. Our resorbable implants Resorb x and Resorb xG are all made out of non-magnetic polymers. Therefore, a magnetic reaction in the MRI is not expected. We are not aware of any problematic cases.

Publications

The SonicWeld Rx® system has been on the market since 2005. The technique has been established and proven over the years. Its success in practice has been proven in several studies.

To the publication overview

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