WO2011063900A1

WO2011063900A1 - Stabilizing clasp for orthoses

Info

Publication number: WO2011063900A1
Application number: PCT/EP2010/006959
Authority: WO
Inventors: Dominique Panzer
Original assignee: Bauerfeind Ag
Priority date: 2009-11-25
Filing date: 2010-11-16
Publication date: 2011-06-03
Also published as: DE102009056710B4; DE102009056710A1

Abstract

The invention relates to orthopaedic products, to orthoses, and to component parts of orthoses, specifically to an improved stabilizing element engaging around the body and serving as a component part of an orthosis, and to a novel method of producing said stabilizing element.

Description

STABILIZATION BAR FOR ORTHESIS

description

The invention relates to orthopedic products, especially orthoses or Orthesenbestandteile. The invention provides an improved stabilizing element, in particular an improved body-embracing stabilizing clasp as part of an orthosis, as well as a new method for producing this stabilizing clasp. The invention also relates to an orthosis which contains this stabilization brace.

Orthoses are therapeutic aids for stabilizing or supporting the movement function of body parts. The supply of functional orthoses focuses on restoring and maintaining the mobility of the musculoskeletal system. Orthoses can have a functionally protective, mobilizing, supportive, movement-limiting and / or corrective effect. The use of orthoses can be done directly post-traumatic or postoperative or conservative, ie to rebuild, to secure or protect the joint functions, eg. B. in degenerative diseases. In order to achieve the required stability depending on the application, one or more stabilizing elements are provided in the orthosis. These are usually designed substantially rod-shaped or cup-shaped. The stabilizing elements designed as shells surround the body part or body joint to be stabilized, for example an extremity joint or the torso in the body Lumbar spine, by more than half of its circumference.

The stabilizing elements support the mechanically stabilizing effect of the orthosis. Orthoses with body-parting stabilizing elements are, for example, functional orthoses for ankles, knee joints, hip and thigh, for the wrist, the elbow joint and the shoulder joint. Such orthoses are characterized in particular by the fact that they usually completely surround the body part to be stabilized, d. H. particularly encompass at least more than half of the circumference of the body part. The body-encompassing stabilizing elements designed for such orthoses are usually formed in the shape of a sphincter and in this case have a circumferential cross-section which encompasses more than one semicircle (greater than 180 degrees) about the body part to be encompassed.

The stabilizing elements are usually formed from a thermoplastic or thermosetting plastic or composite material. Such non-planar or shell-shaped and functionally body-encompassing clasps have a undercut. Such spatial structures are difficult to produce in terms of manufacturing technology. In known Herste II method such Körperumgreifenden clips are usually made of flat blanks (plates) by thermoforming, especially by deep drawing, in the body enclosing spatial final form (conformation of use) brought. This production is complex and usually takes place with high material and personnel deployment. Stabilizing braces for orthoses designed in a known manner are not suitable for alternative and, in particular, more economical production techniques. accessible. There was therefore a need to provide improved stabilizing braces for orthoses, which are to be produced with simpler and more economical production techniques and which have at least equivalent and preferably even better functional properties over known stabilizing elements.

In the prior art, the plastic injection molding technique for the production of parts of orthoses, including stabilizing elements for orthoses is known. Injection-molded elements, however, are generally substantially flat design small and attachments or shells that are unrelated to a body embracing stabilization clasp.

The technical problem underlying the invention was primarily to further develop body-encompassing stabilization braces for orthoses so that they are easier and more economical to produce, and in addition, depending on the specific design, simplify the application and / or expand the functional scope of the brace.

The technical problem is solved completely by the provision of a stabilizing clip for an orthosis, wherein the clip is specially adapted to encompass the body part or body joint to be stabilized at least over a circumferential sector which extends over more than half of the total circumference of the body part means that the clasp has a wrap angle of more than 180 degrees. The improvement according to the invention is primarily characterized in that the clip has at least one groove-shaped material or material thinning, the groove crossing the encompassing circumference of the clip in at least two clasp sections, that is subsections of the circumference (clasp wing) divided. The clasp portions each extend over less than half of the total circumference, that is, less than 180 degrees of the encompassing peripheral sector of the chip. The object of the invention is set forth in more detail in claim 1. Preferred developments are given in the dependent and independent claims.

Essentially, the invention thus provides for providing a per se integral and in the form closed spatial stabilization element in the form of a body-encompassing clasp for use in an orthosis with at least one material thinning which forms a groove and crossing the clasp into at least two "wings" or sections which, taken in themselves, are not embracing the body, that is to say which represent, in particular, less than half of the imaginary circumference of the clasp, it is advantageously possible to use the clasp in the manufacture, the means in the original forming step of the production, substantially flat folded over, that is to produce without trained Umgreifung or undercut, in a simple and above all economical manner, since the initially provided flat unfolded form (Vorkonformation) is easier urformbar and entfombar em preferably immediately following inventive forming step, the urgeformte clasp from its non-body-encircling, substantially planar Vorkonformation along the Werkstoffausdünnungsnut, which serves as a hinged connection of the quasi-flat chip parts between Urformung and reshaping, folded back into the body encompassing final shape, that is folded. In a preferred embodiment, during the conversion The process preferably takes place only once as part of a production method according to the invention. <br/><br/> The invention preferably provides that the material expansion groove in the final shape, that is to say the conformation of the clasp, is additionally preferred a stabilizing the clasp in the transverse direction, preferably arcuately ausgestaltetes (multiaxial) stabilizing element forms.

In the context of this invention, a "material thinning" or "material thinning groove" is understood to mean a zone of material depletion in the solid material of the clasp, which is embodied as a notch or groove or partly analogous to a known film hinge , The Materialausdünnungsnut is not designed as a film hinge, which connects spangles permanently articulated. Such an embodiment is preferably excluded from the present invention. The embodiment of the material thinning groove according to the invention permits a preferably one-time hinged folding of the clasp portions of the chip directly from the originally formed pre-conformation of the clasp, in which the latter, for example immediately after demoulding after the primary shaping process, is substantially flat, is the use conformation.

As the "conformation of use" of the clasp is herein understood the body-encompassing functional form or form of use of the clasp, which extends over more than half of the total circumference of a body part and can embrace a body part In this final conformation, the material thinning groove is in the usage conformation, forms a body-encompassing stabilizing clasp, wherein the material thinning groove does not perform a film hinge-like function in which the clasp segments or "wings" separated by the groove would be hinged On the contrary, a stress of the material thinning groove is preferably formed by the preferably arcuate or multiaxial course of the material thinning groove in the chip, as a result of which the clasp segments delimited by the groove are essentially rigidly connected to one another.

In a preferred embodiment, the material thinning groove is arranged transversely to the body-encircling expansions of the stabilization bracket, preferably perpendicular to this direction. It is understood that are also possible from the vertical deviating transverse configurations. In a particularly preferred embodiment, the material thinning groove divides the clasp centrally or in the region of the middle, preferably into two substantially uniform peripheral sectors of the clasp. Preferably, the Materialausdünnungsnut is arcuately curved in its longitudinal extent. Particularly preferably, the material thinning groove has a multiaxial orientation in the usage conformation of the clasp. In a particular embodiment, it is provided that the clip contains one or more openings. In a preferred embodiment, these apertures can also extend along the material thinning groove, so that they can be cut in groove part offsets. sections are divided. Preferably, each groove part section has its own arcuate or multi-axial course; Each groove part section preferably forms a separate element that stabilizes the clasp. In a preferred variant of this embodiment, it is thus provided that the material thinning groove provided according to the invention is interrupted by at least one opening through the clasp, wherein each material thinning groove portion is either itself multiaxially oriented or uniaxially oriented, the respective other material thinning groove portion then having a different axial orientation such that the totality of the material thinning groove sections results in a multi-axial orientation.

Without wishing to be bound by theory, the arcuate and / or multiaxial orientation of the material thinning groove or plurality of material thinning groove portions enables the material thinning groove to be formed from the substantially planar pre-conformation into the substantially three-dimensional body-encompassing end conformation of the clasp in the forming step in the form of a Umspringelements or "frog" from a first axial conformation in a second axial conformation "jumps", wherein the second axial conformation, which is present in the end conformation of the clip, contrary to the common expectation of a material dilution or material thinning at least in Longitudinal direction of the Materialausdünnungsnut, ie essentially transversely to the circumferential extent of the clip, mechanically stabilizing effect on clasp.

The subject matter of the invention is thus preferably a stabilizing clasp which is arranged in a first substantially planar preconformed clasp. tion, preferably in a simple and economical manner, is formable and then in a body part embracing substantially spatial, three-dimensional end configuration by folding over the at least one Werkstoffausdünnungsnut is deformable. Preferably, the stabilization clasp, preferably in the planar Vorkonformation by injection molding process formable, ie producible. It is understood that the invention comprises the stabilizing clasp in each phase of its formation in the method according to the invention, that is, both in the pre-conformation, as well as in the use conformation.

The invention accordingly also provides a process for producing this stabilizing clasp. This procedure contains at least the steps:

Prototyping of the clasp to produce an at least one material thinning groove running in the clasp in a non-encompassing, that is to say substantially flat, preconformation, which preferably permits initial shaping by means of injection molding, and, preferably immediately following,

- Forming the clasp from the pre-conformation along the at least one material thinning groove into a body part encompassing, that is essentially spatial, three-dimensional use conformation of the clasp.

Preferably, the inventive deformation of the clasp is carried out by, preferably once, folding over the clasp sections which are initially articulated by the material expansion groove in the pre-conformation of the clasp, wherein the material thinning groove is formed from a first axis configuration during the forming in the longitudinal axis. formation, which initially preferably allows the articulated connection of the clasp portions in the pre-conformation, in a second, deviating axis conformation, which preferably in its preferred arcuate or multi-axial orientation allows the stabilization of the clasp in the transverse direction, folds. The material thinning groove preferably converts into a second axis conformation when the clasp is folded over in such a way that, in the configuration of use of the clasp, it forms the clasp, preferably at least in the transverse direction to the circumferential extent of the clasp, which stabilizes the clasp. In a preferred variant of the method, the folding wings are folded over using a force which allows the axis of the material thinning groove to be folded from the first axial conformation under tension into the second axis conformation, which is also under tension. Preferably, the shape tension of the second axis conformation of the formed clasp in use conformation is greater than that of the first axis conformation of the clasp in pre-conformation. The force required to return the second axis conformation of the clip back to the first axis conformation is never achieved during normal use of the clip in or with an orthosis. Preferably, the second axis conformation is due to the selected multiaxial radii so under strain that a folding back with a destruction of the clip. Especially associated with breakage of the material structure.

The primary shaping of the clasp in the pre-conformation preferably takes place by means of an injection molding process. This is carried out in a conventional manner with the known polymeric materials. The planar design of the preconformation allows a simple Final molds after spraying from a substantially two-part injection mold. This represents a significant manufacturing advantage over the previously known deep-drawing process for the production of substantially spatially and especially body embracing designed stabilization braces. In addition to the thermoforming easier to design injection molding, injection molding also allows the connection with other, the injection molding accessible manufacturing and processing steps. Such an at least one additional processing measure represents the installation of inserts during the initial forming. Further such processing measures are the insert technique and the outsert technique. In addition, injection molding also permits in-mold labeling and multi-component injection molding. The latter is particularly for the design of multifunctional stabilization elements with additional stiffening or cushioning, damping elements of high technological and economic advantage over the previous thermoforming process. In addition, the stabilization clasp can also be produced by the process of transfer molding. The deformation process according to the invention from the preliminary information into the end conformation of the clasp is preferably carried out according to the invention by cold forming.

In one variant, this is done by a reshaping assisted by local heating, wherein the local heating is preferably limited to the area of the material thinning groove. The local heating is preferably carried out by hot air and / or thermal radiation. In a further preferred variant, it is provided that the temperature during prototyping be selected so that in the clasp in preconforation at the time of demolding of the clasp or immediately thereafter the area to be reshaped, especially the area with and the material thinning, so tempered So far, the material is so flexible and deformable that there directly heat-assisted forming (folding) can take place. This is preferably achieved by selectively zone-heated tools (molds). In an alternative preferred variant, the forming is carried out by an integrated thermoforming process, which brings the precondensed flat clasp in the arcuate body encompassing final shape.

The invention provides that the primary shaping and / or shaping operations are carried out automatically or at least semi-automatically. Thus, a high number of products in consistent quality and low tolerance can be produced. The automation of the primary forming and forming process is easier to implement and manageable compared to the automation of an equivalent conventional deep drawing process.

In a preferred variant of the method, the folding wings are folded over using a force which causes the axis of the material thinning groove to be folded out of the first axial conformation, which is under tension, into the second axis conformation, which is likewise under tension. Preferably, the shape tension of the second axis conformation of the formed clasp in use conformation is greater than that of the first Achsenkonformation the clip in Vorkonformation. The force required to allow the second axis conformation of the clip to be folded back into the first axis conformation is never reached during normal use of the clip in or with an orthosis. Preferably, the second axis conformation is due to the selected multiaxial radii so under strain that a folding back with a destruction of the clip. Especially accompanied by fracture of the material structure The figures described below illustrate an embodiment of the invention, namely a stabilizing clip for a back orthosis. The inventive concept is not limited to this embodiment.

FIG. 1 shows an overall view of a stabilization clip according to the invention for a lumbar spine orthosis for the human body. The clasp (100) comprises a material thinning groove (150) which divides the clasp in the middle and subdivides the clasp essentially centrally into two clasp wings (110, 120). The clasp (100) has one or more apertures (130) in the region assigned to the spinal column of the body. In the illustrated embodiment, the apertures (130) interrupt the material thinning groove (150). The stabilizing clip (100) shown has a substantially uniform material cross-section, which alone has a material dilution along the line-shaped groove in the region of the material thinning groove (150). The stabilizing clasp (100) has a clasp inner side (140) facing the body and a clasp outer side (170) facing away from the body. The stabilization clasp (100) is shown in the body-encompassing usage conformation. In the use conformation, the material thinning groove (150) has an arcuate, multiaxial profile facing the clasp outer side (170) in order to mechanically stabilize the clasp in the region of the material thinning groove.

FIG. 2 shows the positional position of the clasp in the tool and thus the stabilization clasp in pre-conformation (200), as obtained after the primary shaping process. In the pre-conformation (200), the pincer wings (110, 120) in the area of the material thinning groove (150) are bent at an angle along the crease line in order to form a substantially flat, non-body-encompassing form of the clasp. In this embodiment, the clip can be inventively easily prototypes.

FIG. 3 shows a cross section (arrow in FIG. 2) of the stabilizing bar in the area of the material thinning groove (150) in the pre-conformation (200). In a first axis conformation (160), the material thinning groove (150) in the pre-conformation (200) forms an arcuate, multiaxial course curved toward the inside of the clasp (140). FIG. 4 shows the use conformation (300) in the folded-over body-encompassing end conformation of the clasp after the forming process according to the invention. Therein, the clasp portions (1 10, 120) in the region of the material thinning groove (150) are connected by these smoothly aligned. FIG. 5 shows the cross-section of the clasp (arrow in FIG. 4) in the area of the material thinning groove (150) in the use conformation (300) of the clasp after forming. In the second axis configuration formation (180), which adjusts itself by folding over from the pre-information (200) into the use conformation (300) along the material thinning groove (150), the material thinning groove (150) has a bow-shaped, multiaxial arched inwards to the clasp outer side (170) Course on.

Claims

claims

1 . Clasp (100) for an orthosis, which is designed to predominantly surround a body part in its overall circumference, characterized in that the clasp has at least one material expansion groove (150) which transverses the clasp into at least two clasp sections (1 10, 120 ) each extending over less than half the total circumference of the body to be wrapped.

2. Clip according to claim 1, wherein the material thinning groove (150) divides the clasp centrally or in the region of the middle into two clasp sections (1 10, 120).

3. Clip according to one of the preceding claims, wherein the Werkstoffausdünnungsnut (150) has a multi-axial course in its longitudinal extent.

4. Clip according to one of the preceding claims, wherein the clip for producing in a first Vorkonformation (100) in which the at least one Werkstoffausdünnungsnut (150) connecting the clasp portions (1 10, 120) angled, is formable.

5. A clasp according to claim 4, which consists of the urgeformten preconfiguration (200) by folding the angled clasp portions (1 10, 120) in an area in the Materialausdünnungsnut (150) smoothly aligned arrangement in a body part in its total extent predominantly encompassing use conformation (300) is deformable.

6. Clip according to one of the preceding claims, which is urformbar by injection molding.

7. A method of making a brace (100) for an orthosis characterized in any one of the preceding claims, including the steps of:

Prototyping of the clasp with at least one transverse material thinning groove (150) disposed therein in a non-embracing pre-conformation (200) with clasp portions (10, 120) angled along the material thinning groove, and reshaping the clasp along the material thinning groove (150) from the pre-formed urine (200 ) into a body part usage conformation (300).

8. The method of claim 7, wherein the reshaping of the clasp by folding the urgeformte angled Spangenabschnit- te (1 10, 120) along the Materialausdünnungsnut (150) in a material thinning in the material smoothing alignment of the clasp sections takes place.

9. The method according to claim 8, wherein the at least one material thinning groove (150) during forming in its longitudinal axis from a first axis conformation (160) of the pre-conformation (200) of the clasp in a deviating second axis conformation (180) in the use conformation (300) Clasp folds over.

10. The method of claim 9, wherein the material thinning groove (150) during forming so in a second Achsenkonformati- On (180) flips over so that the material thinning groove in the use conformation (300) forms an element stabilizing the clasp.

1 1. The method according to any one of claims 7 to 10, wherein the original forms of the clasp takes place by injection molding.

12. The method of claim 1 1, wherein the injection molding is associated with at least one measure which is selected from: installation of inserts, insert technology, outsert technology, Inmoldlabel- ling, multi-component injection molding and transfer molding.

13. The method according to any one of claims 7 to 12, wherein the forming is carried out by thermoforming.

14. orthosis, comprising one or more clips according to one of claims 1 to 6.

15. The orthosis according to claim 14, which is selected from knee orthosis, hip orthosis, thigh orthosis, spinal orthosis,

Wrist brace, ankle brace, elbow brace and shoulder brace.