FILTER NEEDLE
20240001035 ยท 2024-01-04
Inventors
Cpc classification
International classification
Abstract
Filter needle comprising a hub having a proximal end arranged for removable connection to a syringe body, and having a distal end in which a needle is mounted, the hub provided with a channel between the proximal end and the distal end, for when the syringe body is connected, establishing a fluid connection between the syringe body and the needle, wherein a filter unit is mounted in the channel of the hub.
Claims
1. A filter needle comprising: a hub having a proximal end arranged for removable connection to a syringe body, and having a distal end in which a needle is mounted, the hub provided with a channel between the proximal end and the distal end, for when the syringe body is connected, establishing a fluid connection between the syringe body and the needle, wherein a filter unit is mounted in the channel of the hub, the filter unit further including a sheet of woven filter material, wherein the sheet of woven filter material is fixated to a surrounding material, wherein the surrounding material protrudes through the sheet of woven filter material.
2. The filter needle according to claim 1, wherein the surrounding material is a hub material.
3. The filter needle according to claim 1, wherein the filter unit further includes a sleeve, preferably a tubular sleeve, wherein the surrounding material is a material of the sleeve.
4. The filter needle according to claim 1, wherein an outer edge of the sheet of woven filter material is fixated to the surrounding material, wherein the surrounding material protrudes through the outer edge of the sheet of woven filter material, preferably through meshes of the outer edge of the sheet of filter material.
5. The filter needle according to claim 3, wherein the sheet of woven filter material is positioned halfway of the height of the tubular sleeve.
6. The filter needle according to claim 1, wherein the sheet of woven filter material is disc-shaped.
7. The filter needle according to claim 3, wherein the filter unit, in particular the tubular sleeve, is elastic.
8. The filter needle according to claim 1, wherein the surrounding material, is of a thermoplastic material, preferably wherein the material of the tubular sleeve of the filter unit is of a thermoplastic elastomer, in particular of a thermoplastic styrenic elastomer.
9. The filter needle according to claim 8, wherein the thermoplastic elastomer has a Shore A hardness of between 85 and 105, measured according to standard ISO 868.
10. The filter needle according to claim 8, wherein the thermoplastic elastomer has a Melt Flow Rate between 15 and 20 g/10 min measured according to standard ISO 1133 at 230 C. and 2.16 kg.
11. The filter needle according to claim 1, wherein the sheet of woven filter material is woven from a polyamide or polyester or polypropylene yarn.
12. The filter needle according to claim 1, wherein the sheet of woven filter material is a twill weave filter.
13. The filter needle according to claim 1, wherein the surrounding material is integrated to the sheet of woven filter material by locally melting of the surrounding material.
14. The filter needle according to claim 1, wherein the sleeve is connected to the sheet of woven filter material by overmoulding to form an integrated filter unit or wherein the hub is connected to the sheet of woven filter material by overmoulding to form an integrated hub with sheet.
15. The filter needle according to claim 1, wherein the filter unit comprising the sleeve is formed by injection moulding via a double injection gate, or wherein the hub comprising the sheet of filter material is formed by injection moulding via a double injection gate.
16. The filter needle according to claim 15, wherein each injection gate of the double injection gate is positioned at another side from the sheet of woven filter material.
17. The filter needle according to claim 1, wherein the filter unit is symmetric with respect to a symmetry plane through the sheet of woven filter material.
18. The filter needle according to claim 3, wherein the outer diameter of the filter unit, in particular the outer diameter of the tubular sleeve, is larger than an inner diameter of the channel of the hub.
19. The filter needle according to claim 3, wherein the filter unit is fitted into the channel of the hub by means of press-fitting.
20. The filter needle according to claim 3, wherein the height of the tubular sleeve is smaller than the outer diameter of the tubular sleeve.
21. The filter needle according to claim 3, wherein the filter unit is mounted in the channel of the hub adjacent the distal end of the hub towards a needle opening.
22. The filter needle according to claim 1, wherein in the channel, adjacent a needle opening, a chamber is formed having a conically shaped wall.
23. The filter needle according to claim 3, wherein in the channel of the hub a locking element is provided for locking the filter unit, in particular the sleeve, in the channel.
24. The filter needle according to claim 23, wherein the locking element is a circumferential rim.
25. The filter needle according to, wherein a mesh size of the woven filter material is between 2 m and 150 m.
26. A syringe comprising a syringe body for containing a medical solution and a filter needle according to claim 1.
27. Assembly of a needle hub having a proximal end arranged for removable connection to a syringe body, and having a distal end to which a needle is mounted, the hub provided with a channel between the proximal end and the distal end, for when the syringe body is connected, establishing a fluid connection between the syringe body and the needle, wherein in the channel a filter unit is provided, wherein the filter unit comprises a tubular sleeve and a sheet of woven filter material fixated in a tubular sleeve wherein material of the sleeve protrudes through an outer edge of the sheet of wove filter material, wherein the filter unit is positioned in the channel.
28. The filter unit for use in the filter needle of claim 3, wherein the filter unit includes a sheet of woven filter material fixated in a tubular sleeve.
29. Method for manufacturing a filter unit for use in the filter needle of claim 3, the method comprising: providing a sheet of woven filter material; placing the sheet of woven filter material in a sleeve mould; overmoulding the sheet of woven filter material with thermoplastic material as sleeve material, such that the thermoplastic material is injection moulded through an outer edge of the sheet of woven filter material, in particular through meshes of the sheet of woven filter material.
30. Method according to claim 29, wherein overmoulding comprises using two injection gates.
31. Method for manufacturing a hub for use in the filter needle of claim 1, the method comprising: providing a sheet of woven filter material; placing the sheet of woven filter material in a hub mould; overmoulding the sheet of woven filter material with thermoplastic material as hub material, such that the thermoplastic material is injection moulded through an outer edge of the sheet of woven filter material, in particular through meshes of the sheet of wove filter material.
32. A kit of a filter unit according to claim 28, and of a needle hub having a proximal end arranged for removable connection to a syringe body, and having a distal end to which a needle is mounted, the hub provided with a channel between the proximal end and the distal end.
33. A kit according to claim 32, further comprising a syringe body.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0057] The disclosure is further elucidated by means of a schematic drawing. In the drawing the following figures are shown.
[0058]
[0059]
[0060]
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DETAILED DESCRIPTION OF THE DRAWINGS
[0064] The figures are given by way of schematic representations of embodiments of the disclosure. Like features are denoted with the same or similar reference numbers. The figures are not necessarily drawn to scale and are to be seen as schematic.
[0065]
[0066] The hub 2 extends along a central longitudinal axis A, and is preferably circular symmetric along the said axis. Advantageously, the needle 4 is arranged to the hub 2 such that a central longitudinal axis of the needle coincides with a central longitudinal axis of the hub 2, hereinafter all being referred to as the axis A. Also, the channel 6 is provided in the hub 2 having a central longitudinal axis coinciding with the longitudinal axis A of the hub 2.
[0067] A filter unit 8 is mounted in the channel 6 of the hub 2. The filter unit 8 is arranged to filter a solution, in particular a fluid solution, passing through the channel 6. More specifically, the filter unit 8 is arranged to prevent particulates or solid impurities from passing the filter unit 8. The filter unit 8 can hereto be used in two different manners. The filter unit 8 can, in a first manner, prevent particulates from travelling from the syringe body to the needle 4. As such, the filter unit 8 can prevent certain, possibly damaging or dangerous, particulates from being injected into a patient, when the needle 1 is used for injecting fluid. In a second manner, the filter unit 8 can prevent certain particulates from travelling from the needle 4 to the syringe body, when the needle 1 is used for sucking up fluid. As such, the filter unit 8 can prevent particulates from being sucked up from any kind of solution container into the syringe body. The filter unit 8 can for example prevent that any undesired precipitates formed in a medical solution end up in the syringe body or, later on, in a patient. It is stressed however that a specific filter unit 8 can only be used in one of the two manners described above. One same filter unit 8 can not be used to first filter a solution travelling from the needle 4 to the syringe body and to second filter the same or a different solution travelling from the syringe body to the needle 4. If one were to do so, the undesired particles filtered from the solution travelling towards the syringe body would be picked up by the same or a different solution travelling towards the needle 4. In
[0068]
[0069] The tubular sleeve 12 is made from an elastic material. This allows the tubular sleeve 12 to stretch or compress under stress, the tubular sleeve 12 being elastically deformable. A useful effect hereof arises when the filter unit 8 is to be mounted in the channel 6 of the hub 2 as seen in
[0070] The tubular sleeve 12 can be made from a thermoplastic elastomer, preferably a thermoplastic elastomer which has a Shore A hardness of between 85 and 105. Using a thermoplastic elastomer provides the advantages of an elastic material described herein. Furthermore, thermoplastic elastomers allow for efficient and cost-effective manufacturing methods. The ease with which thermoplastic elastomers can be formed and shaped provides for easy, consistent and cost-effective mass production of the tubular sleeve 12.
[0071] As mentioned above, the filter unit 8 also comprises a woven filter 10. The woven filter 10 filters particles of a predefined size out of a solution passing therethrough. Using a woven filter is known to bear some advantages in relation to using, for example, a membrane filter. A woven material is, for example, less sensitive to tearing and creates a lower pressure loss than a membrane filter, as such a woven filter may be more resistant against the pressure and/or velocity of the fluid flowing through the channel because it provides a higher fixation force with the material, in particular TPE of the tubular sleeve. The characteristics of a woven material depend on how the material is woven i.e. which type of weave is used. The woven filter 10 is manufactured according to a twill type weave. A twill weave material is found to have the best filter characteristics in view of the present application. Advantageously, a twill weave material using two yarns having a specific warp and weft mesh count can be used for filtering efficiency. Also, the size of the meshes of the woven material is determined in function of the particle size that is to be filtered out of the solution. More specifically, a twill weave material is found to have the best filter results according to USP789. Preferably, the woven filter 10 is woven from a polyamide yarn. Polyamide yarn is easy to process, and allows for an efficient and cost-effective mass production of the woven filter 10.
[0072] Referring now to
[0073] Referring now to
[0074] As can be seen in
[0075]
[0076] The injection moulding process allows for an efficient and cost effective mass production of the tubular sleeve 12. As mentioned above, the woven filter 10 has the same advantage due to being woven from a polyamide yarn. These steps mainly form the production process for the filter unit 8 as a whole. As such, the filter unit 8 is in itself efficient and cost effective to mass produce.
[0077]
[0078] Alternatively to the injection moulding process, the filter unit may be assembled e.g. by welding such as thermo-welding or by medical use compliant adhesives. For example, the sleeve 12 may be provided in two parts, a first part for being arranged at one side of the filter, and a second part for being arranged at the opposite side of the filter. The filter, in particular an outer edge thereof, can then be glued or welded, or point-welded or otherwise connected to first part, such that the outer edge of the filter overlaps the tubular sleeve. Then, the second part can be connected to the filter and the first part, e.g. by welding or gluing as well. Thus, a firm connection between the first part, the filter and the second part can be obtained to form the filter unit. It is recognised though that this method involves more steps, and, thus, more risks on leakage.
[0079] Now turning to
[0080] The diameter of the channel 6, in this example, decreases towards the distal end 2a of the hub 2. Near the proximal end 2a of the hub 2, an inner diameter 63a of the channel 6 is slightly smaller than the outer diameter 14 of the tubular sleeve 12 of the filter unit 8. The channel 6 may thus have a proximal part 6b with a larger diameter 63b, a distal part 6a with a smaller diameter 63a and a tapered part 6c connecting the proximal part 6b and the distal part 6a. The distal part 6a here forms a chamber 20 in which the filter unit 8 can be received. As such, and due to the elastic properties of the tubular sleeve 12, the filter unit 8 can be press-fitted in the channel 6 when in the position illustrated by
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[0083]
[0084] The syringe of the present invention and its filter needle can be used either to suck up liquid into the syringe or to inject liquid from the syringe. Although the main application of the syringe and its filter needle are in the medical field it can be used for non-medical applications as well. The most important application of the syringe and its filter needle is to draw up medical solution from a vial into the syringe or to inject a medical solution into a patient with the purpose of effectively filtering out particulate contaminants present in the medical solution. The filter needle is particularly suitable to filter out from medical solutions particulate contaminants primarily having a particle size of larger than 5 m provided the mesh size of the woven filter material is 5 m. Therefore the syringe and its filter needle are particularly suitable for ophthalmic applications but also other medical applications wherein it is important to avoid the risk of having particles injected into the human body can be envisaged.
[0085] The term medical solutions or medical liquid or medical fluid as used throughout herein is intended to refer to any solution intravenously or intramuscularly fed to a patient, including medication injected by a hypodermic syringe.
[0086] Herein, the invention is described with reference to specific examples of embodiments of the invention. It will, however, be evident that various modifications, variations, alternatives and changes may be made therein, without departing from the essence of the invention. For the purpose of clarity and a concise description features are described herein as part of the same or separate embodiments, however, alternative embodiments having combinations of all or some of the features described in these separate embodiments are also envisaged and understood to fall within the framework of the invention as outlined by the claims. The specifications, figures and examples are, accordingly, to be regarded in an illustrative sense rather than in a restrictive sense. The invention is intended to embrace all alternatives, modifications and variations which fall within the spirit and scope of the appended claims. Further, many of the elements that are described are functional entities that may be implemented as discrete or distributed components or in conjunction with other components, in any suitable combination and location.
[0087] Many variants are possible and are comprised within the scope of the following claims.