WO2023084159A1

WO2023084159A1 - Medical device, medical kit and method

Info

Publication number: WO2023084159A1
Application number: PCT/FI2022/050742
Authority: WO
Inventors: Martin Kaufmann; Josh LUEBBERS; Jouni Niemi; Michael LINDROOS; Jimmy TAKKI
Original assignee: Dassiet Oy
Priority date: 2021-11-10
Filing date: 2022-11-09
Publication date: 2023-05-19

Abstract

A medical device and a kit comprising said device. The medical device comprises at least one support element, and a piece of fabric. The support element is in an orthopedically supporting shape, having a supporting surface to be arranged towards the object to be supported and an opposite distal surface. The piece of fabric is arranged on the supporting surface, such that there is a friction coefficient in range of 0.5 – 1.0 between the piece of fabric and the supporting surface.

Description

MEDICAL DEVICE , MEDICAL KIT AND METHOD

BACKGROUND

The invention relates to a medical device .

The invention further relates to a medical kit .

The invention still further relates to a method for providing temporary medical support or protection .

A problem with known medical devices for giving support and/or protection, especially intended for animals , such as dogs and other pets and domestic animals , is that they tend to limit using the supported obj ect , such as a limb, a leg for instance , very strictly . This may cause problems with healing of the obj ect .

BRIEF DESCRIPTION

Viewed from a first aspect , there can be provided an medical device , comprising at least one support element and a piece of fabric, wherein the support element is in an or- thopedically supporting shape , the support element having a supporting surface to be arranged towards the obj ect to be supported and an opposite distal surface , wherein the piece of fabric is arranged on the supporting surface , such that there is a friction coefficient in range of 0 . 5 - 1 . 0 between the piece of fabric and the supporting surface .

Thereby a medical device that allows certain controlled amount of movements between the support element and the supported obj ect such that said movements promotes an effective blood circulation in the obj ect and thus promotes healing may be achieved .

Viewed from a further aspect , there can be provided an medical kit , comprising the medical device as defined in this disclosure , wherein the support element and the piece of fabric are separately present in said kit , and wherein said kit further comprises instructions including instructions for arranging the piece of fabric around the obj ect , arranging the supporting surface of the support element on the piece of fabric arranged around the obj ect , such that friction coefficient in range of 0 . 5 - 1 . 0 between the piece of fabric and the supporting surface is reached, and restraining the medical device on its correct place on the ob j ect .

Thereby a medical kit that allows certain controlled amount of movements between the support element and the supported obj ect such that said movements promotes an effective blood circulation in the obj ect and thus promotes healing may be achieved .

Viewed from a further aspect , there can be provided a method for providing temporary medical support or protection, comprising :

- providing a support element , and a piece of fabric, wherein the method comprises :

- arranging the piece of fabric on the obj ect to be supported and/or protected,

- arranging the support element on the piece of fabric on the obj ect , such that

- there is a friction coefficient in range of 0 . 5 - 1 . 0 between the piece of fabric and the support element .

Thereby a method that allows certain controlled amount of movements between the support element and the supported obj ect such that said movements promotes an effective blood circulation in the obj ect and thus promotes healing may be achieved . The arrangement , the kit and the method are characterised by what is stated in the independent claims . Some other embodiments are characterised by what is stated in the other claims . Inventive embodiments are also disclosed in the specification and drawings of this patent application . The inventive content of the patent application may also be defined in other ways than defined in the following claims . The inventive content may also be formed of several separate inventions , especially if the invention is examined in the light of expressed or implicit sub-tasks or in view of obtained benefits or benefit groups . Some of the def initions contained in the following claims may then be unnecessary in view of the separate inventive ideas . Features of the different embodiments of the invention may, within the scope of the basic inventive idea, be applied to other embodiments in combination or instead thereof .

In one embodiment , the support element is made of a composition comprising thermoplastic polymer and wood particles in form of granules , plates and/or fibers .

An advantage is that the material is easy to work with and has a relatively light weight while maintaining the necessary orthopedic support . A further advantage is that the material may provide a high breathability that promotes healing of wounds and reduces irritation of skin under the support element . A still further advantage is that the material may be reheated and reshaped, and thus wastage of the material may be reduced . A still further advantage is that the material is transparent to x-rays , thus enabling examination of the obj ect without removing the support element .

In one embodiment , the piece of fabric is made of material comprising thermoplastics , preferably of 100 % polyester . An advantage is that a light , breathable and non-wetting piece of fabric may be achieved .

In one embodiment , the piece of fabric has a selfattaching surface structure having ability to fasten with itself as such .

An advantage is that the device i s simple to use and number of components thereof may be reduced .

In one embodiment , the self-attaching surface structure of the piece of fabric comprises a fibre loop bundle fabric .

An advantage is that an elastic and soft self-attaching surface structure may be achieved .

In one embodiment , the piece of fabric has ability to fasten with itself in a normal temperature , such as in temperature of 20 ° C - 25 ° C .

An advantage is that the medical device is easy to use at normal room temperatures without need for heating the fabric .

In one embodiment , the support element comprises at least one opening, arranged for alleviating local pressure of the obj ect .

An advantage is that irritation, chafes and abrasions of the obj ect may be avoided .

In one embodiment , the support element comprises a chutelike shape , wherein the supporting surface lies on in- ner/concave surface of said shape . An advantage is that a multi-directional support of the obj ect may be created .

In one embodiment , the support element comprises a weak point or line for easing cutting of said support element , preferably arranged for guiding the support element to be reduced in si ze for increasing motional freedom of the supported obj ect .

An advantage is that an optimal support of the obj ect for different stages of the healing process of the obj ect may be created easily .

In one embodiment , the support element comprises a sole element arranged on the distal surface of the support element for creating a friction adding element .

An advantage is that risks of slipping of patient using the medical device may be reduced . Additionally, the sole element may protect the support element against wear and wetting .

BRIEF DESCRIPTION OF FIGURES

Some embodiments illustrating the present disclosure are described in more detail in the attached drawings , in which

Figure la is a schematic side view of a support element and method,

Figure lb is a schematic view of the support element and method shown in Figure la from another direction,

Figure 1c is a schematic cross-sectional view of the support element and method shown in Figure la, Figure 2a is a schematic side view of another support element and method,

Figure 2b is a schematic view of the support element and method shown in Figure 2a from another direction,

Figure 3a is a schematic side view of another support element and method,

Figure 3b is a schematic view of the support element and method shown in Figure 3a from another direction, and

Figure 4 is a schematic view of a kit comprising an medical device .

In the figures , some embodiments are shown simplified for the sake of clarity . Similar parts are marked with the same reference numbers in the figures .

DETAILED DESCRIPTION

Figure la is a schematic side view of a support element and method, Figure lb is a schematic view of the support element and method shown in Figure la from another direction, Figure lc is a schematic cross-sectional view of the support element and method shown in Figure la, Figure 2a is a schematic side view of another support element and method, Figure 2b is a schematic view of the support element and method shown in Figure 2a from another direction, Figure 3a is a schematic side view of another support element and method, and Figure 3b is a schematic view of the support element and method shown in Figure 3a from another direction .

It is to be noted, that in this disclosure the term "medi- cal" covers also veterinary medicine . The medical device 100 may be used for immobilisation of fractures and strains etc. of bones, ligaments, nervous system etc. of human beings and animals. The medical device may also be used in treatments of soft tissue and skin, such as wounds and sores. In one embodiment, the medical device 100 is used for supporting another medical device, such as a prosthesis. In one embodiment, the medical device 100 is for supporting a limb of an animal, such as a mammal, e.g. a dog.

The medical device 100 comprises a support element 1 and a piece of fabric 2. The support element 1 is shaped in a three-dimensional shape that gives a desired orthopedical support to an object to be supported. The "object" may be any part of the body of a human being or an animal.

The support element 1 has two surfaces or sides: a supporting surface 3 to be arranged towards the object to be supported and an opposite distal surface 4.

In one embodiment, the support element 1 is made of material that comprises metal or polymer material or both. Said metal may be e.g. aluminum. Said polymer material may be thermoplastic or thermoset material. In one embodiment, said material is a composite material comprising polymer material and reinforcing material. In one embodiment, the polymer material comprises thermoplastic polymer and the reinforcing material comprises wood particles in form of granules, plates and/or fibers. In one embodiment, the thermoplastic polymer is non-biodegradable polymer. In another embodiment, the thermoplastic polymer is biodegradable polymer. In one embodiment, the biodegradable polymer comprises caprolactone homopolymer and the reinforcing material comprises platy wood particles. This composite material is easy to work with, recyclable and has a light weight. It can also be shaped by using elevated temperature, such as about 65 °C, if necessary.

In one embodiment, the thickness of the support element 1 is in range of 0.8 mm - 8 mm, preferably 2 mm - 4 mm. The thickness may be equal essentially all over the plate, or there may be variations e.g. for alleviating shaping of the plate.

According to an aspect, the support element 1 is manufactured by casting. According to an aspect, the support element 1 is manufactured by 3D printing. According to an aspect, the support element 1 is manufactured by heat forming from a plate or sheet of material.

In one embodiment, the support element 1 is shaped to the shape of the object by pressing the support element against the object. In one embodiment, the support element 1 is shaped to the shape of the object by pressing the support element against a 3D model that has at least substantially the shape of the object.

In one embodiment, the support element 1 is heated to a higher temperature to ease shaping thereof. For example, support elements manufactured of composition comprising thermoplastic polymer (such as and wood particles in form of granules, plates and/or fibers can be heated to e.g. about 65 °C, and then shaped in the required shape. The heating may be carried out e.g. in a water bath, in an oven or in a microwave oven.

In one embodiment, the medical device 100 comprises just one support element 1. In another embodiment, there are two or even more discrete support elements 1 in use in the in the medical device. Typically, the support element 1 has a concave shape towards the object to be supported. In one embodiment, the support element 1 has a chute-like or shell-like shape, wherein the supporting surface 3 lies on the inner/concave surface of said shape. Some examples of this kind of shapes are shown in the Figures.

In one embodiment, the support element 1 has a shape that is shaped and sized to a specific object or indication. Figures la - 3b are showing some examples of specifically shaped support elements.

The support element 1 shown in Figures la - 1c is a carpus caudal support for a dog.

The support element 1 shown in Figures 2a - 2b is a pelvic caudal support for a dog.

The support element 1 shown in Figures 3a - 3b is a carpus cranial support for a dog.

In one embodiment, the support element 1 comprises a weak point 5 or a weak line 6 whereby the mechanical structure of the support element 1 is weakened compared to surrounding parts of the support element.

In one embodiment, the weak point 5 or line 6 are arranged so that they ease for reducing size of the support element by e.g. cutting or sawing. In other words, the weak point 5 or line 6 makes it easier to remove selected pieces of the support element, even without removing the support element on the object to be supported.

In one embodiment, the weak point 5 or line 6 eases for reducing stiffness of the support element by e.g. cutting or sawing. In other words, no pieces of the support ele- ment are to be removed, but the weak point 5 or line 6 makes it easier to produce cuts, slits and openings in the support element that provides a more bendable structure of said support element.

In one embodiment, the support element 1 is solid, i.e. without through holes. In another embodiment, the support element 1 comprises at least one opening 13, such as shown in Figures la, lb. According to an aspect, the opening (s) 13 is/are arranged and dimensioned such that pressure against the object can be reduced, and thus risks of chafes and abrasion of the object is minimized.

In one embodiment, the support element 1 comprises plurality of openings or perforations that may have various functions, for example promoting breathability of the object covered by the support element, and adapting stiffness and friction characteristics of the support element.

In one embodiment, the piece of fabric 2 is in form of a strap or band that can be wound around the object to be supported .

In one embodiment, the piece of fabric 2 has a tubular structure dimensioned such that the object to be supported can be arranged therein. In one embodiment, the tubular structure has an open end and a closed end, being e.g. in form of a sock.

In one embodiment, the piece of fabric 2 has a selfattaching surface structure 5. This has an ability to fasten with itself as such.

In one embodiment, the self-attaching surface structure 5 of the piece of fabric comprises a fiber loop bundle fab- rrc . The self-attaching surface structure 5 provides a stepless adjustment of the attachment, and thus e.g. an optimal compression towards the object may be created.

In one embodiment, the piece of fabric 2 can be fasten with itself in a normal temperature, such as in temperature range of 20 °C - 25 °C.

In one embodiment, all the surface area of the piece of fabric contains the self-attaching surface structure 5.

In one embodiment, there are some area(s) or section (s) in the piece of fabric 2 that do not have the self-attaching surface structure 5, or in other words: only part of the surfaces of the piece of fabric 2 comprises the selfattaching surface structure 5.

In one embodiment, the whole piece of fabric 2 is without the self-attaching surface structure 5. Then, the medical device 100 is secured on the object by e.g. using additional attachment substances or means, such as an adhesive, tape or staples, and/or by tying/knotting the piece of fabric.

In one embodiment, the piece of fabric 2 is made of material comprising thermoplastics. In one embodiment, the piece of fabric 2 is a textile material made of polyester, such as of 100 % polyester. In one embodiment, the piece of fabric 2 comprises polyester yarn of type 50/25 SDY.

In one embodiment, the piece of fabric 2 comprises or is made completely of 3D air mesh -type fabric. An advantage of this type of fabric is high breathability and water permeability. Following this, if the piece of fabric 2 get wet, it will dry quickly, and water does not cause problems to skin under the device.

In one embodiment, the further material layer 10 is made of 3D air mesh -type fabric described above.

The piece of fabric 2 is preferably bi-directionally elastic or stretchy such that the supported object may rotate in an extent that promotes healing of the object.

In one embodiment, the thickness of the piece of fabric 2 is in range of 2 mm - 4 mm. The thickness may be equal essentially all over the fabric, or there may be variations in the thickness.

The structure of the piece of fabric 2 is preferably breathable in order to alleviate healing of the object covered by the fabric.

In one embodiment, the piece of fabric 2 comprises at least one active additive for promoting healing of possible wound (s) relating to the supported object. In one embodiment, the piece of fabric 2 comprises silver or silver alloy particles or fibres. In one embodiment, the piece of fabric 2 is a one-layer product. In one embodiment, the piece of fabric 2 comprises at least two layers of material, each of which may have a functionality of its own.

The piece of fabric 2 has been tied around the object OB to be supported such that a suitable compression is created against the object. The piece of fabric 2 has been fastened with itself or fastened with a suitable fastening element, such as a hook-and-loop fastener surface (Velcro) , a tape, a glue, or one or more staples. The support element 1 is arranged on the piece of fabric 2 so that the support element 1 is placed on a supporting position on the object OB. The supporting surface of the support element 1 is towards the object OB and the piece of fabric 2 lies between the support element 1 and the object OB. The support element 1 is shaped into an anatomically precise shape according to the shape of the object OB.

There is a certain specific friction coefficient between the support element 1 and the piece of fabric 2. Said friction coefficient is selected in range of in range of 0.5 - 1.0. In one embodiment, said friction coefficient is selected in range of 0.6 - 0.9. In one embodiment, said friction coefficient is selected in range of 0.7 - 0.8. In one embodiment, said friction coefficient is about 0.75. The desired friction coefficient can be reached by materials selection of the support element 1 and the piece of fabric 2, and selecting the surface textures thereof in a suitable way.

In one embodiment, the arrangement 100 comprises an outer attachment layer 7, such as a layer of fabric, that is arrangeable on/around the support element 1 for restraining the support element 1 on the object to be supported. The outer attachment layer 7 may be of similar materials and have same properties as the piece of fabric disclosed in this disclosure.

In one embodiment, the arrangement 100 comprises at least one padding 10. The padding 10 may be arranged between the support element 1 and the piece of fabric 2, In one embodiment, the padding 10 is fastened to the piece of fabric 2 or to the support element 1. In another embodiment, the padding 10 is arranged between the piece of fabric 2 and the object to be supported. In one embodiment, such as shown in Figures la, lb, the support element 1 comprises a sole element 8 that is arranged on, or that is at least extending on, the distal surface 4 of the support element. The sole element 8 comprises material that creates a higher friction against e.g. typical floor materials or tarmac. In one embodiment, said material is selected from rubbers, thermoset elastomers, and thermoplastic elastomers.

Figure 4 is a schematic view of a kit 200 comprising the medical device 100 according to this disclosure. According to an aspect, components of the medical device 100 according to the current disclosure are arranged in a medical kit 200. The medical kit 200 thus comprises the support element 1 and the piece of fabric 2, at least. The medical kit 200 comprises also instructions 9 including instructions for at least:

- arranging the piece of fabric 2 around the object,

- arranging the supporting element 1 on the piece of fabric 2 arranged around the object, such that a friction coefficient in range of 0.5 - 1.0 applies between the piece of fabric 2 and the support element 1, and

- restraining the medical device 100 on its correct place on the object.

In one embodiment, instructions 9 further comprises instructions for reducing the size of the support element 1 along the weak points/lines 5, 6 described earlier in this disclosure .

In one embodiment, the instructions 9 further comprises instructions for treating the patient. In one embodiment, the instructions 9 further comprises instructions for follow-up of the patient's condition. The instructions 9 may be e . g . in a paper-form or in an electrical form, or it may comprise an electronically readable code , such as a qr-code . In one embodiment , the instructions 9 comprises instructions in form of interactive (multi ) media .

The support element 1 and the piece of fabric 2 included in the kit 200 are preferably shaped and si zed for use in a certain indication or body part . The instruction document 11 may include instructions for that specific use . Thus , the use of the kit is simple and does not require skills of highly educated health care personnel .

In one embodiment , the support element 1 and the piece of fabric 2 included in the kit 200 are provided separately therein .

In one embodiment , the medical kit 200 is packed and distributed in a package 11 . In one embodiment , the package 11 is watertight , thus it is possible to heat the support element in the package using a water bath without wetting or soaking said support element .

In one embodiment , the medical kit 200 comprises at least one accessory 12 . The accessory 12 may comprise an additional fastening means , such as a piece of a cohesive tape , for instance .

In one embodiment , the medical kit 200 comprises an exposing element 14 . This element can be arranged for exposing a premature removal of the medical device 100 . In one embodiment , the exposing element 14 also makes it impossible or at least more difficult to remove the medical device without a correct key, tool , or code . This kind of exposing element 14 may comprise e . g . a plastic belt that is fastened around the medical device 100 arranged on the ob- j ect OB . The belt comprises a locking element that cannot be opened without correct key, tool , or code .

In one embodiment , the exposing element 9 comprises an indication marking that breaks or change its appearance when the orthopaedic device 100 is removed . The indication marking may be e . g . a tape or corresponding element , or j ust a line or other geometrical element drawn/printed on the orthopaedic device 100 .

In one embodiment , the exposing element 9 comprises a glue layer or a polymer layer arranged on a suitable surface of the device . Said layer get broken and/or it collects fluff when the device 100 is removed .

The invention is not limited solely to the embodiments described above , but instead many variations are possible within the scope of the inventive concept defined by the claims below . Within the scope of the inventive concept the attributes of different embodiments and applications can be used in conj unction with or replace the attributes of another embodiment or application .

The drawings and the related description are only intended to i llustrate the idea of the invention . The invention may vary in detail within the scope of the inventive idea defined in the following claims .

REFERENCE SYMBOLS

1 support element

2 piece of fabric

3 supporting surface

4 distal surface

5 weak point

6 weak line

7 outer attachment layer

8 sole element

9 instructions

10 padding

11 package

12 accessory

13 opening

14 exposing element

100 medical device

200 medical kit

Claims

1 . A medical device , comprising

- at least one support element, and

- a piece of fabric wherein

- the support element is in an orthopedically supporting shape , the support element having a supporting surface to be arranged towards the obj ect to be supported and an opposite distal surface, wherein

- the piece of fabric is arranged on the supporting surface , such that

- there is a friction coefficient in range of 0 . 5 - 1 . 0 between the piece of fabric and the supporting surface .

2 . The medical device as claimed in claim 1 , wherein the support element is made of a composition comprising

- thermoplastic polymer and

- wood particles in form of granules , plates and/or fibers .

3 . The medical device as claimed in claim 2 , wherein

- the thermoplastic polymer is non-biodegradable polymer .

4 . The medical device as claimed in claim 2 , wherein

- the thermoplastic polymer is biodegradable polymer .

5 . The medical device as claimed in claim 4 , wherein

- the biodegradable polymer compri ses caprolactone homopolymer and the reinforcing material comprises platy wood particles .

6 . The medical device as claimed in claim 1 , wherein

- the support element is made of a metal or alloy, such as aluminum .

7. The medical device as claimed in claim 1, wherein

- the support element is solid without openings.

8. The medical device as claimed in claim 1, wherein

- the support element comprises at least one opening.

9. The medical device as claimed in claim 8, wherein

- the at least one opening is arranged for alleviating local pressure of the object.

10. The medical device as claimed in claim 1, wherein

- the support element comprises a chute-like shape, wherein the supporting surface lies on inner/concave surface of said shape.

11. The medical device as claimed in claim 1, wherein

- the support element (1) comprises a weak point/line for easing cutting of said support element.

12. The medical device as claimed in claim 10, wherein

- the weak point/line is arranged for guiding the support element to be reduced in size for increasing motional freedom of the supported object.

13. The medical device as claimed in claim 1, wherein

- the piece of fabric is made of material comprising thermoplastics, preferably of 100 % polyester.

14. The medical device as claimed in claim 1, wherein

- the piece of fabric is in form of a strap or band for winding around the object to be supported.

15. The medical device as claimed in claim 1, wherein the piece of fabric has a self-attaching surface structure having ability to fasten with itself as such.

16. The medical device as claimed in claim 15, wherein

- the self-attaching surface structure of the piece of fabric comprises a fiber loop bundle fabric.

17. The medical device as claimed in claim 1, wherein the piece of fabric has ability to fasten with itself in a normal temperature, such as in temperature of 20 °C - 25 °C.

18. The medical device as claimed in claim 1, comprising

- an outer attachment layer, such as a layer of fabric, arrangeable on the support element for restraining the support element on the object to be supported.

19. The medical device as claimed in claim 1, wherein the support element comprises

- a sole element arranged on the distal surface of the support element for creating a friction adding element.

20. A medical kit, comprising

- the medical device as claimed in claim 1, wherein

- the support element and the piece of fabric are separately present in said kit, and wherein said kit further comprises

- instructions including instructions for

- arranging the piece of fabric around the object,

- arranging the supporting surface of the support element on the piece of fabric arranged around the object, such that friction coefficient in range of 0.5 - 1.0 between the piece of fabric and the supporting surface is reached, and

- restraining the medical device on its correct place on the object.

21. The medical kit as claimed in claim 20, wherein the instructions further comprises 21

- instructions for reducing the size of the support element along weak points/lines provided in the support element .

22. The medical kit as claimed in claim 20, wherein the instructions further comprises

- instructions for treating the patient and/or instructions for follow-up of the patient's condition.

23. A method for providing temporary medical support or protection, comprising:

- providing a support element, and a piece of fabric, wherein the method comprises:

- arranging the piece of fabric on the object to be supported and/or protected,

- arranging the support element on the piece of fabric on the object, such that

- there is a friction coefficient in range of 0.5 - 1.0 between the piece of fabric and the support element.

24. The method as claimed in claim 23, comprising

- heating the support element to a higher temperature, such as to e.g. about 65 °C, for easing shaping thereof.