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IPS Implants® Distraction

IPS Implants® Distraction

As the world market leader in the fields of distraction osteogenesis and patient-specific implant solutions, we have combined our expertise in both areas to set a new milestone in distraction techniques.

Based on our well-established distraction systems and the use of modern IPS® technologies we developed IPS Implants® Distraction, a new distraction solution, that is individually adapted to the patient. As part of the IPS® product family, IPS Implants® Distraction is supported by an easy and efficient process – from the planning up to the functionalized distractor.

Efficient planning process 

Efficient planning process

The planning process of a patient-specific IPS® distractor is based on a simple and efficient interaction with the user via the IPS Gate®. Thanks to a wide variety of planning options, bone thickness, distraction vectors and the post-operative situation can be simulated precisely. Planning, manufacturing and shipping are all managed in one system, eliminating the need for coordinating multiple service providers. For the user this results in maximum efficiency, flexibility and functionality.

High safety through specific drill and marking guides

High safety through specific drill and marking guides

The position and screw holes of the distractors can be precisely determined using patient-specific drill and marking guides which enable the smooth transfer of the virtual planning to the OR. Integrated steel sleeves allow direct drilling without the need for additional drill guides. On request, the drilling and marking guides can be made of additively manufactured titanium, in which case they can also be used as sawing guides.

Optimal precision-fit

Optimal precision-fit

The distractors are made of high-strength titanium alloy as standard and are dimensionally stable during insertion. The fixation plates are based on the patient's individual CT scan and are already checked at the factory for an optimal three-dimensional precision-fit. IPS® distractors can be offered in different versions and allow a high degree of individuality.

Compatibility with standard instruments

Compatibility with standard instruments

The IPS® distractors are based on our standard distractors. The standard distractors serve not only as a reference for planning, but also for the indications of the respective IPS® distractor. Our IPS® distractors have the same geometries and technical properties as the standard distractors, hence, all standard accessories such as activators and instruments can be used without difficulty.

Realization options

IPS® distractors are available in two versions: 

  • IPS® distractors with modified standard components are based on the existing distractor components from our standard portfolio, which are individually adapted to the patient, for example by bending, cutting and grinding. 
     
  • IPS® distractors with custom-made special components partly consist of components that are planned and manufactured specifically for the patient. The special components are characterized by the fact that they are newly milled or lasered.

Our comprehensive range of patient-specific IPS® distractors covers the following anatomical regions:
 

Alveolar Ridge

Alveolar Ridge

  • TRACK Distractors
Mandible

Mandible

  • Zurich II and Micro Zurich II Distractors
  • Zurich Pediatric Ramus Distractor
  • Horizontal and Ramus Distractors
  • Right Angle Driven Distractor
  • Mandibular Telescoping Distractor
  • Zurich Wood und Zurich Bidirectional Distractors
  • Ramus Transport Distractor
  • ThreadLock Transport and Herford Transport Distractors
Maxilla

Maxilla

  • Zurich Pediatric Maxillary Distractor
  • Maxillary Telescoping Distractor
  • TS-MD Distractor
  • Liou Cleft Distractor
Transversal plane of the maxilla and mandible

Transversal plane of the maxilla and mandible

  • Rotterdam Palatinal Distractor
  • Rotterdam Midline and Bologna Midline Distractors
Midface and Cranium

Midface and cranium

  • Arnaud and Marchac Distractors
  • Kawamoto Distractor
  • Posterior Cranial Vault Distractor
External midface distractor

External midface distractor

  • RED II Distractor

In addition, patient-specific planning aids tailored to the use of selected standard distractors can be manufactured to facilitate the performance of surgery. Here, the surgical procedure is simulated virtually and the markings of the osteotomy lines are transferred to the designed planning aids.

A special highlight of external distraction is our IPS® RED II according to Prof. J. Obwegeser. It is planned and manufactured with modified fixation and retention plates, which enable stronger anchoring to the skull bone and thus facilitate attachment in cases of poor bone quality.

Case studies

Bidirectional distraction of the mandibular body and ascending branch

Bidirectional distraction of the mandibular body and ascending branch

  • Patient-specific Zurich Bidirectional Distractor with individually fabricated plates
  • Fixation with 1.5-mm standard screws
Transport distraction of the mandible

Transport distraction of the mandible

  • Patient-specific ThreadLock Transport Distractor with individually fabricated plates and additively manufactured reconstruction plate
  • Fixation with 1.5-mm standard screws
Multipart distraction of the cranium

Multipart distraction of the cranium

  • Patient-specific Posterior Cranial Vault Distractor with individually fabricated plates and additive manufactured fixation plate of the fronto-orbital ligament
  • Fixation with 1.5-mm standard screws
Bilateral distraction of the maxilla

Bilateral distraction of the maxilla

  • Patient-specific drill and marking guide for Maxillary Telescoping Distractor

Surgical technique | Bilateral distraction of the mandible

Virtual planning

1. Virtual planning

To create the case the patient data and other case-related information are uploaded to the IPS Gate® web-based platform.
The data are prepared for case planning on the basis of information and requirements. An integrated chat function as well as web meetings are available for direct communication between the user and the IPS® developer. In consultation with the user, the drill and marking guides as well as the distractors optimized for the specific case are generated.
At the end the user approves the design for production.

Insertion of the guides and performing the osteotomy

2. Insertion of the guides and performing the osteotomy

After completing vestibular access, the drill and marking guides are inserted. The osteotomy line is defined using the cutting mark. Afterwards, the screws can be loosened again and the drill guide is removed again.
Osteotomy is now performed buccally using the marks. In adults it is also necessary to mobilize the mandible lingually, in the area of the osteotomy, with a chisel.

Fixation of the distractors

3. Fixation of the distractors

After ensuring mobility of the individual bone fragments, the distractor is attached with at least four screws on each side. The correct function of the distractor must be checked intra-operatively. It should be noted that the activator must remain accessible and movable after closing the suture.

Note:
In addition to the IPS® distractor, the respective activator must be available in a sterile condition in addition to the necessary osteo- synthesis accessories (KLS Martin osteosynthesis screws of the planned diameter as well as the matching twist drills and screw-drivers). They are not included in the IPS® package.

Latency period

4. Latency period

After the implantation of a distraction system, a latency period must first be observed before the actual distraction period begins. The latency period is to be assessed by the surgeon depending on the indication and usually lasts approx. 5–7 days, depending on the patient.

Distraction period

5. Distraction period

Active distraction begins at the end of the latency period. The generally recommended distraction length per day is 1 mm. Active distraction is performed with a patient screwdriver (Ref. 51-500-90-07). One complete turn corresponds to 0.5 mm here. It is recommended to make one complete turn (360° = 0.5 mm) each morning and evening. This value always corresponds to that of the standard distractor. An arrow on the screwdrivers indicates the direction of activation.

Consolidation period

6. Consolidation period

The consolidation period lasts approx. 8-12 weeks, depending on the patient. The distraction system may only be removed after complete bony development (consolidation) so as not to endanger the outcome of the distraction. However, the activator should be removed after the distraction period is completed. Remote Release Activators can be separated directly at the activation point after completion of the distraction period, while conventional activators must be detached from the distractor using special detachment forceps. Orthodontic treatment can already be started during the consolidation period.

Removal of the distractor

7. Removal of the distractor

Once the consolidation period has been completed, all distractor components must be removed. The type and extent of postoperative treatment and/or rehabilitation measures are to be coordinated with the patient by the attending user.

Osteosynthesis Accessories

In addition to the IPS® distractor, the following osteosynthesis accessories in sterile condition are required for the surgical restoration:

  • If the IPS® distractor is not fitted with a fixed activator: an activator matching the IPS® distractor (standard or remote release)
  • The patient screwdriver pertaining to the IPS® distractor and other necessary distraction instruments (e.g., plate holding instruments, activator arm separating forceps, etc.)
  • Sufficient number of KLS Martin osteosynthesis screws in the planned diameters and matching lengths
  • A screwdriver suitable for the planned osteosynthesis screws
  • If no drill-free screws are used: a twist drill suitable for the planned osteosynthesis screws

Legal basis for IPS Implants®

According to the regulations of the MPG (Medical Device Act) § 3 Sentence 8, a custom-made product is a medical device manufactured on prescription according to specific design specifications and which is intended for the exclusive use for a named patient. For this reason a separate inquiry is necessary in every case.

The written prescription is a release for the technical offer (design of the products). This is to be submitted in writing by the user at the same time as the required order for the economic offer if he/she agrees with the desired case planning.

Shipment is not permissible as a matter of principle without this mandatory regulatory document.

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