GB2530250A

GB2530250A - Medical instrument kit and method of manufacture thereof

Info

Publication number: GB2530250A
Application number: GB1415743.2A
Authority: GB
Inventors: Jeremy Paul Joseph; Nathan Longhurst
Original assignee: Individual
Current assignee: Individual
Priority date: 2014-09-05
Filing date: 2014-09-05
Publication date: 2016-03-23
Anticipated expiration: 2034-09-05
Also published as: GB2530250B; GB201415743D0

Abstract

A kit 10 of surgical instruments 12 connected together by interconnecting members 14 such as sprues or runners. The handles 16 of the instruments and the interconnecting members are integrally formed, either by moulding from a plastic or by 3D printing, but are separable by snapping. The kit may contain a variety of forceps, scalpels and scissors, a needle holder, a speculum and a vectis. The handles are formed onto metal instrument heads (figure 8) having protruding stems (19) with through holes, preferably by overmolding.

Description

Intellectual Property Office Application No. GB1415743.2 RTN4 Date:24 February 2015 The following terms are registered trade marks and should be read as such wherever they occur in this document:

M oorfield (registered)

Intellectual Property Office is an operating name of the Patent Office www.gov.uk/ipo Medical Instrument Kit and Method of Manufacture thereof

FIELD OF THE INVENTION

[01] The present invention relates to a medical instrument kit.

[02] The invention also relates to a method of manufacturing a medical instrument kit.

BACKGROUND OF THE INVENTION

[03] Surgical procedures to address medical or cosmetic problems and/or issues are common in this day and age.

[04] This has led to the development of standard procedures for addressing certain problems or issues wherein a predetermined set of medical instruments or tools are required for and used during the surgical procedure.

[05] Medical instruments for such procedures are generally provided in packs or sets comprising the instruments that may be required for the procedure. The instruments br the procedures are put in packs prior to being sterilised. However, some supplementary or spare instruments may he made up singly.

[06] In some cases the sorting of the instruments into packs is done off site with the packs provided to the clinic, surgery or medical institution. This can lead to situations wherein an incolTect instrument has been placed in the pre-assembled pack or a required instrument is missing. This problem can still occur even where the packs are put together on site pror to being transported to the operating theatre.

[07] The packaging of instruments, depending on the nature of the surgical procedure and the number of instruments required, has an effect on the set up time in the operating theatre. The set up time for a procedure can significantly increase if a large number of instruments arc needed as they each have to he unpacked and arranged in a set manner pnor to the operation.

[08] In most cases, the instruments are resterilisahie. However, the re-sterilisation of instruments involves quite an expense as the instruments have to be washed and then re-sterilised. The re-sterilisation process is also quite time consuming and can take about 3 hours to complete.

[09] In addition, there is a risk that the instrument would he damaged while being washed and cleaned.

[10] It is possible to obtain single use disposable instruments, and such instruments are required to be used in some establishments. These instruments generally come pre-sterilised in single packs which have to be opened individually or may come in a set of instruments in one pack. These types of instruments are expensive, hut avoid the need for on site preparation.

[11] Where surgeons demand the employment of single use instruments or establishments choose to use them, this can lead to unnecessary wastage and cost implications if sonic instruments are opened for a procedure and then not utilised.

[12] It is desirable to provide a medical instrument kit which addresses one or more of the problems and disadvantages identified above.

SUMMARY OF THE INVENTION

[13] A first aspect of the invention provides a surgical instrument kit comprising a plurality of surgical instruments and one or more connecting members attaching the plurality of surgical instruments together in a roughly planar arrangement, wherein each of the plurality of surgical instruments comprises a handle portion integrally formed with the one or more connecting members, and wherein each of the plurality of surgical instruments is separable from the one or more connecting members.

[14] The present invention provides a surgical instrument kit for use in a surgical procedure which removes the need for individually packaged instruments to be provided in packs or sets br the surgical procedure and enables the instruments to he laid out for a procedure in a convenient and/or logical arrangement.

[15] Connecting the surgical instruments with one or more connecting members has the benefit in that all the instruments for a procedure may be provided in a ready to hand manner and in one piece, thus reducing set up time.

[16] In addition, due to the fact that the surgical instruments are provided in a single kit which may he sterilised and packaged in a single packaging means that it is less likely that an incorrect instrument is placed in the pre-assembled pack or a required instrument is missing as may occur in packs of the prior art.

[17] Furthermore, due to the fact that the surgical instruments are provided in a single kit, the surgical instrument are easier to store than multiple instruments. This is beneficial in locations where storage space is hmited for example in field hospitals.

mobile clinics, remote locations.

[18] The kit in accordance with the invention is also easier to keep sterile than multiple individually packaged instruments. This is advantageous in locations where facilities or resources for keeping instruments sterile are minimal or may he stretched for example in field hospitals, mobile clinics, remote locations, developing and third [19] Preferably the kit comprises two or more different surgical instruments.

[20] In exemplary embodiments, the plurality of surgical instruments comprises at least a forceps and/or a scissors and/or a needle holder.

[21] In exemplary embodiments, the plurality of surgical instruments comprises a speeulum.

[22] In exemplary embodiments, the kit may comprise a first rack section for hoMing one or more preformed surgical instruments.

[23] This allows surgical instruments to he added to the kit in order to supplement the plurality of surgical instruments having moulded handle portions integrally formed with the one or more connecting members. This may be required where the supp'emental surgical instrument(s) needs to he specially formed and may not he manufactured in the same way as the plurality of surgical instruments or wherein it is more cost effective to manufacture the supplemental surgical instrument(s) in a different way to the plurality of surgical instruments.

[24] The supplemental surgical instrument(s) may comprise a knife and/or a scalpel and/or surgical blade. In exemplary embodiments, the kit comprises one or more supplemental instruments located within the first rack section.

[25] In exemplary embodiments, the kit further comprises a second rack section for holding one or more preformed surgical instruments. The second rack section may be configured to hold different or similar instruments as the first rack section.

[26] In exemplary embodiments, the second rack section is configured to hold a vectis and the kit comprises a veetis located within the second rack section. The second rack section is designed to hold the vectis in a secure manner. In exemplary configurations, the second rack section comprises a plurality of recess shaped and sized such that the vectis may be snap fitted therein.

[27] In exemplary embodiments, one or more of the plurality of surgical instruments is configured to be snapped off or permanently disconnected from the one or more connecting members so as to separate it from the one or more connecting members.

[28] The handle portions of the plurality of surgical instruments may moulded or 3D printed.

[29] In exemplary embodiments, the kit is a surgical instrument kit for an ophthalmic surgery procedure.

[30] A second aspect of the invention provides a method of manufacturing a surgical instrument kit comprising the steps of: providing a mould assemhly having a template configured to form two or more surgical instrument handle portions connected in side by side arrangement by one or more connecting members; filling the mould assembly with a liquid or pliable material; and removing the hardened/set matenal from the mould; and sterilising the formed two or more surgical instruments.

[31] The method in accordance with the second aspect provides a method of producing surgical instruments which is more cost effective than method currently used to produce surgical instruments. In addition, the method allows the production of a surgical kit having all or the majority of the instruments needed for a surgical procedure. Due to the fact that all or the majority of the instruments needed for the surgical procedure are contained in the produced kit, the risk of an instrument missing or the kit containing an unwanted instrument is significantly reduced. In addition the set up time for a procedure is significantly reduced as the instruments can be arranged as required for the procedure.

[32] In exemplary embodiments, the mould assembly comprises a template configured Ui form two or more dilferent surgical inslrumenl handle porlions.

[33] The method may further comprise the step of inserting a non-handle portion of one or more surgical instruments into the template prior to fifing the mould assembly with a liquid or pliable material.

[34] The non-handle portion may be a metallic component. In exemplary embodiments, the non-handle portion is in the form of a metallic component made via a metal injection moulding process or other suitable process.

[35] In exemplary embodiments wherein a non-handle portion of one or more surgical instruments is inserted into the template, the step of filling the mould assembly with a liquid or pliable material is configured to overmold at least a portion of the or each non-handle portion within the template with the liquid or pliable material. This provides a strong bond between the non-handle portion and the handle portion of the instrument.

[36] In exemplary embodiments, the tempatc is configured to form surgical instrument handle portions for a forceps and/or a scissors and/or a needle holder.

[37] In exemplary embodiments, the template is configured to form a speculum.

[38] In exemplary embodiments, the template is configured to form a first rack section for heAding one or more preformed surgical instruments.

[39] The first rack section may be configured to hold a knife andlor a scalpel and/or surgical blade.

[40] In exemplary embodiments, the template may also he configured to form a second rack section for holding one or more preformed surgical instruments. The second rack section maybe designed to hold similar or different surgical instrument(s) to the first rack section. In exemplary configurations, the second rack section comprises a plurality of recess shaped and sized such that the vectis may be snap fitted therein.

[41] In exemplary configurations, the second rack section is configured to hold a vectis.

[42] The liquid or pliable material may comprise a plastics material. By using a plastics material to form the handle portions of the surgical instruments means that the instruments will be cheaper to manufacture than fully metallic surgical instruments.

This can result in suhstantia costs savings in view of the fact that some surgeons are reluctant to use rc-sterilised instrumcnts and as a rcsult the majority of surgical instruments are used only once then discarded.

[43] In cxemplary cmbodimcnts. the mcthod further comprises the step of packaging the formed two or more surgical instruments prior to sterilising the formed two or more surgical instrumcnts.

BRIEF DESCRWTION OF THE DRAWIIGS

[44] Embodiments of the invention wifi now he described with reference to the accompanying drawings, in which: [45] Figure I is a isometric view of an embodiment of a surgical instrument kit in accordance with the invention; [46] Figure 2 is a plan view of the surgical instrument kit of Figure 1; [47] Figure 3 is a perspective view of an embodiment of a mould assembly for producing the surgical instrument kit of Figure 1; [48] Figure 4 is a side view of the mouki assemily of Figure 3; [49] Figure 5 is a schematic view of the lower mould of the mould assemily of Figure 3; [50] Figure 6 is a schematic view of the lower mould of the mould assemily of Figure 3 with the non-handle portions of the instruments positioned in the template of the lower mould; [51] Figure 7 is a schematic view of the formed surgical instrument kit in the lower mould of the mould assembly; [52] Figure 8 is a schematic view of non-handle portion of a surgical instrument forming part of the surgical instrument kit of the invention; and [53] Figure 9 is a schematic view of a surgical instrument formed with the non-hand'e portion of Figure 8.

DETAILED DESCRIPTION OF EMBODIMENT(S)

[54] Thc preceding discussion of the background to the invention is intended only to facilitate an understanding of the invention. It. should be appreciated that the discussion is not an acknowledgement or admission that any of the material referred to was part of the common general knowledge as at the priority date of the application.

[55] Throughout the description and claims of this specification, the words "comprise" and "contain" and variations of the words, for example "comprising" and "comprises", mean "including hut not limited to". and is not intended to (and does not) exclude other components, integers or steps.

[56] Throughout the description and claims of this specification, the singular encompasses the plural unless the context otherwise requires. lii particular, where the indefinite article is used, the specification is to he understood as contemplating plurality as well as singularity, unless the context requires otherwise.

[57] Features, integers or characteristics, and compounds described in conjunction with a particular aspect, embodiment or example of the invention are to be understood to be applicable to any other aspect, embodiment or example described herein unless incompatible therewith.

[58] Referring to Figures 1 and 2, an embodiment of a surgical instrument kit 10 in accordance with the first aspect of the invention is shown. The kit 10 is shown in the form of a kit comprising instruments for an ophthalmic surgery procedure but it would he understood that different instrument configurations or arrangements may he possible depending on the intended use of the kit.

[59] The kit 10 comprises a plurality of surgical instruments 12 and one or more connecting members 14 attaching the plurality of surgical instruments 12 together in a roughly planar arrangement.

[60] Each of the plurality of surgical instruments 12 comprises a handle portion 16 and a non-handle portion 18. The handle portion 16 is integrally formed with the one or more connecting members 14, and is separable from the one or more connecting members 14. In the embodiment shown, the handle portions 16 and the connecting members 14 are lormed by a moulding process as later described.

[61] In the embodiment shown, the kit 10 comprise two or more different surgical instruments 12 in the form of forceps, scissors, a needle holder and a speeulum.

Further details of the instruments are outlined below.

[62] The kit 10 further comprises a first rack section 20 for holding one or more preformed surgical instruments, and second rack section 22 for holding one or more preformed surgical instruments.

[63] In the embodiment shown, the first rack section 20 is configured to hold four preformed surgical instruments (not shown). The preformed surgical instruments may comprise a knife and/or a scalpel andlor a surgical blade. The first rack section 20 comprises supporting members 30 having opposed semi-circular recesses 21 thereon.

The semi-circular recesses 21 on the supporting members 30 are shaped and sized such that the surgical instruments may he snap fitted into the recesses 21.

[64] In the embodiment shown, the second rack section 22 is configured to hold a single preformed surgical instrument (not shown) in the form of a vcctis. The second rack section 22 comprises supporting members 32 having semi-circular recesses 23 thereon shaped and sized such that the vectis may be snap fitted into the recesses 23.

[65] A tab 24 is provided proximate the position of each of the plurality of surgical instruments 12. The tabs 24 include an alphanumeric indicator to facilitate the identification of the surgical instruments 12. The alphanumeric indicator may be moulded with the tab and may be in the form of alphabetic andlor numeric characters.

[66] In the embodiment shown, nine tabs are provided and numbered from 1-9 to indicate die instruments of the kit 10. The reference numbers for the instruments 12 have the prefix 12 in front of the corresponding tab number for simplicity. The instruments in the kit 10 identifiahlc arc: conjunctival scissors 121; Vannas scissors 122; needle holders 123; Moorfields forceps 124; corneal forceps 125; angled forceps 126: vectis (not shown); speculum 128, and mosquito forceps 129.

[67] A method of manufacturing a surgical instrument kit in accordance with the second aspect of the invention will now he described with reference to figures 4 to 7.

[68] Firstly. a mould assembly 50 is provided. The mould assembly 50 comprises a template 56 configured to form two or more surgical instrument handle portions 16 connected in side by side llTangement by one or more connecting members 14.

[69] In the embodiment shown, the mould assembly 50 comprises an upper mould section 52 and a lower mould section 54, and the temp'ate 56 is configured to form the kit 10 described above.

[70] The template 56 defines the mould cavities for the handle portions 16 of the respective instruments 12, and comprises sprues and runners for facilitating the flow of liquid or pliable material into the mould cavities. The end of the sprues and runners adjacent the mouM cavities for the handle portions 16 are of a smaller dimension than the rest of the sprues and runners in order to enable to instruments 12 to be snapped off or disconnected from the connecting niembers 14 as required.

[71] The upper and lower sections of the template 56 may be integrally formed with the upper and lower mould sections 52, 54 respectively. Alternatively, the upper and lower sections of the template 56 may be formed onto faces of one or more inserts configured to be received within the upper and lower mould sections 52, 54. The use of inserts provides a modular system allowing the alteration and/or adaption of the con figuration of the template.

[72] The non-handle portions 18 of the instruments 12 are then inserted into a respective recess in the template section in the lower mould section 54 as shown in figure 6. An example of a non-handle portion 18 is shown in figure 8.

[73] The non-handle portions 18 are provided where the mould material is unsuitable for the function required. such as a sharp blade, thin tip or pivot connection e.g. of a scissors.

[74] A terminal end of the non-hanWe portion 18 may define a protuberance 19 (as shown in figure 8) for connecting the non-handle portion 18 to the handle portion 16 of the surgical instrument. The shape and size of the protuberance is configured to create a robust mechanical connection between the handle portion 16 and the non-handle portion 18.

[75] The non-handle portions 18 may he formed of a different material to the hanWe portion and preferably is foirned of a metallic material for example stainless steel, titanium, aluminium etc. In the embodiment shown, with the exception of the speculum. the non-handle portions form the tips of the respective surgical instruments.

The metallic tips of the surgical instruments may be formed by any suitable means for example by a metal injection moulding process, a die casting process, a stamping process, a bending process, a forging process, a machining process etc. [76] The upper mould section 52 is then placed on top of the lower mould section 54 and thc mould assembly 50 filled with thc liquid or pliable material. The liquid or pliable material may be in the form of a therinosetting polymer or a thermoplastic polymer such as polyethylene, nylon, polypropylene. ABS etc. [77] The mould cavity for the handle portion 16 and the recess for the non-handle portion 18 are arranged such that the liquid or pliable material will ovcrmnould at least a portion of the non-handle portion 18. In embodiments wherein the non-handle portion 18 comprises the protuberance 19, the liquid or pliable material will overmould the protuberance. An example ol a surgica' instrument is shown in ligure 9 depicting the overmould between the hand portion 16 and the non-handle portion 18.

[78] Depending on the required surgical instrument, the mouki cavity br the hanWe portion thereof may comprise one or more changes in its cross-sectional profile such that the thickness of the moulded handle portion can be varied so as to change the flexibility of different areas of the handle portion.

[79] Once set, the hardenedlset material is removed from the mould assembly 50.

[80] One or more supp'emental mould processes may he perbormed in order to overmould different material onto the handle portion of one or more of the surgical instruments in the kit. This allows the strength and/or rigidity of the handle portion of one or more of the surgica' instruments to he altered to he different to other surgical instruments in the kit.

[81] The formed kit 10 is then optionally supplemented with the supp'emental preformed surgical instruments as described above prior to the fully assembled kit being packaged and sterilised.

[82] Due to the configuration of the kit 10 in accordance with the invention, only a single sterilisation process is needed to sterilise the surgical instruments needed for a surgical procedure. This is different to some known surgical packs where each instrument in the pack needs to be sterilised individually prior to being placed in separate packaging.

[83] In addition, the method of manufacturing a kit in accordance with the invention allows the surgica' instruments to be manufactured such that they are prearranged in the required set manner for a surgical procedure. This means that valuable time may he saved during the step up prior to the procedure.

[84] While the kit 10 in accordance with the invention has been described being manufactured by a moukling process, the kit 10 may instead he manufactured via an additive manufacturing process. Both the handle portions 16 arid the non-handle portions 18 may be manufactured using such a process.

[85] The medical or dental practitioner may customise the layout of the instruments in the kit in accordance with his/her preference for a certain procedure. This may be accomplished by providing the practitioner with a user interlace (e.g. a web page.

computer or smartphone application, which allows himlher to select the instruments he/she requires and the order he/she would like them to he arranged. The appropriate inserts for the mould would be chosen to create (he required template configuration for moulding, or if the kit is to he manufactured via an additive manufacturing process. create the required data input file to be manufactured using a suitable 3D printer.

[86] Although the invention has been described above with reference to one or more preferred embodiments, it will be appreciated that various changes or modifications may be made without departing from the scope of the invention as defined in the appended claims.

[87] While the invention has been described above with reference to an ophthalmic surgery kit it would be understood that the kit could be a kit for use in surgery in another branch of medicine or dentistry. For example the method in accordance with the invention may be utilised to produce kits for dentist or plastic surgery procedures etc.

Claims

Claims 1. A surgical instrument kit comprising a plurality of surgical instruments and one or more connecting members attaching the plurality of surgical instruments together in a roughly planar arrangement. wherein each of the plurality of surgical instruments compnses a handle portion integrally formed with the one or more connecting members, and wherein each of the plurality of surgical instruments is separable from the one or more connecting members.
2. A kit according to claim 1. wherein the kit comprises two or more different surgical instruments.
3. A kit according to claim I or claim 2, wherein the p'urality of surgical instruments comprises at least a forceps and/or a scissors and/or a needle holder.
4. A kit according to claim any one of claims 1 to 3. wherein the plurality of surgical instruments comprises a spcculum.
5. A kit according to claim any one of claims I to 4, further comprising a first rack section for holding one or more preformed surgical instruments.
6. A kit according to claim. further comprising a knife and/or a scalpel and/or a surgical blade located within the first rack section.
7. A kit according to claim 5 or claim 6, further comprising a second rack section for holding one or more preformed surgical instruments.
8. A kit according to claim 7, further comprising a vectis located within the second rack section.
9. A kit according to any one of the preceding claims, wherein the surgical instrument is configured to he snapped off or permanently disconnected from the one or more connecting members so as to separate it from the one or more connecting members.
10. A kit according to any one of the preceding daims, wherein the handle portions of the plurality of surgical instruments are moulded.
11. A kit according to any one of claims 1 to 8, wherein the handle portions of the plura'ity of surgical instruments arc 3D printed.
12. A method of manufacturing a surgical instrument kit comprising the steps of: providing a moukl assembly having a template configured to form two or more surgical instrument handle portions connected in side by side arrangement by one or more connecting members; filling the moukl assembly with a liquid or pliable material; and removing the hardened/set material from the mould; and stcrilising thc formcd two or morc surgical instrumcnts.
13. A method according to claim 12. wherein the mould assembly comprises a template configured to form two or more different surgical instrument handle portions.
14. A method according to claim 12 or claim 13. further comprising the step of inserting a non-handle portion of onc or morc surgical instruments into the template prior to filling the mould assembly with a liquid or pliable material.
15. A method according to claim 14, wherein the step of filling the mould assembly with a liquid or pliable material is configured to overmold at least a portion of the or each non-handle portion within the template with the liquid or pliable material.
16. A method according to any one of claims 12 to 15, wherein the template is configured to form surgical instrument, handle portions for a forceps andJor a scissors and/or a needle hokler.
17. A method according to any one of claims 12 to 16, wherein the temp'ate is configured to form a speculurn.
18. A method according to any onc of claims 12 to 17, whcrein thc temp'ate is configured to form a first rack section for holding one or more preformed surgical instruments.
19. A method according to claim 18. wherein the first rack section is configured to hold a knife and/or a scalpel and/or surgical blade.
20. A method according to claim 18 or 19, wherein the template is configured to form a second rack section for holding one or more preformed surgical instruments.
21. A method according to claim 20. wherein the second rack section is configured to hold a vectis.
22. A method according to any one of daims 13 to 21, wherein the liquid or pliable material comprises a plastics material.
23. A method according to any one of claims 13 to 22. further comprising the step of packaging the foimed two or more surgical instruments prior to sterilising the formed two or more surgical instruments.
24. A surgical instrument kit as generally hereinbefore described with reference to and/or illustrated in the accompanying drawings.
25. A method of manufacturing a surgical instrument kit as generally hereinbefore described with reference to and/or illustrated in the accompanying drawings.