GB2208845A - Ophthalmic instrument packaging - Google Patents

Abstract

A package suitable for a single use or re-usable surgical instrument comprises elements (1) and (3) which are capable of co-operating with one another so as to surround and substantially enclose at least the surgical surface of the surgical instrument. When element (1) co-operates with element (2) the instrument at or near its hub is in contact with both elements (1) and (2) and is gripped by at least one of the elements so that the surgical surface of the instrument does not contact either element (1) or (2). A recess (12) in one of the elements (3) allows access of the fingers or forceps to the hub of the instrument when the elements (1) and (3) no longer co-operate with one another, and a sealing film or laminate is provided to seal the co-operating elements (1) and (2) from access to the air. <IMAGE>

Description

OPHTHALMIC INSTRUMENT PACKAGING This invention relates to packaging for surgical instruments.

Instruments used in ophthalmic surgical procedures are increasingly single use sterile disposable products rather than re-usable instruments. Disposable instruments have traditionally been double packed in simple transparent heat sealed plastic/laminated paper envelopes or blisters (called the primary package) enclosed in a similar outer pouch (the secondary package), subsequently being sterilised by ethylene oxide gas or irradiation.

Delicate ophthalmic instruments, particularly those used in cataract operations, such as cystotomes, specialised cutting instruments, irrigating cannulas and irrigating/aspirating devices are prone to damage or blunting in transit or storage if they are not well protected. Simple envelopes and blisters are often inadequate for this purpose resulting in the instruments being crushed or blunted by pressing the cutting surfaces against the external packaging.

Alternative packs have been used which are excessively protected to the point where it is difficult to open the pack and remove the instrument in the preparation or operating room environment.

This invention describes a simple, economical, easy to use primary package for single use or re-usable ophthalmic surgical instruments which ensures protection from damage or blunting in transit or storage.

According to this invention a package for surgical instruments especially ophthalmic surgical instruments, comprises packaging elements (a) and (b) which are capable of co-operating with one another so as to surround at least the surgical surface of the surgical instrument. When element (a) cooperates with element (b) the instrument at or near its hub is in contact with both elements and is gripped by at least one of the elements so that the surgical surface of the instrument does not contact either element (a) or element (b). There is a recess (c) provided in one of elements (a) and (b) to allow access of the fingers or forceps to the hub of the instrument when the elements (a) and (b) no longer cooperate with one another and there is a sealing film or laminate (d) to seal the cooperating elements (a) and (b) from access to the air so preventing contamination.

Usually the package is a two part transparent blister elements (a) and (b) - made from plastics material, e.g. polyethylene tetraphthalate, polyvinyl chloride (PVC), polysulphone, polypropylene, polyester or various transparent polymers, either by vacuum forming or by injection moulding. Such blisters should be made from sufficient gauge plastics to make the blister resistant to crushing.

The packaging elements (a) and (b) are designed so that when they co-operate with one another they are capable of substantially enclosing the surgical instrument.

Conveniently one of the packaging elements is designed mainly to hold the instrument and the other element designed mainly to protect the instrument. Preferably elements (a) and (b) are separate elements but in another embodiment they could be hinged to one another.

Other designs are possible but it is essential that when the two elements (a) and (b) co-operate with one another the instrument at or near its hub is in contact with both elements and gripped by at least one of the elements so that the surgical surface of the instrument does not contact either element (a) or element (b).

In one preferred embodiment of this invention a holder element (a) is provided with a recess to house the surgical instrument, this recess preferably having a raised portion (or bridge) substantially transverse to the longitudinal axis of the instrument when it is housed therein. This raised portion is itself provided with a transverse slot or channel so as to receive and grip the spine or cannula of the instrument near its hub. Alternatively this bridge and transverse slot could be located so as to receive and grip a portion of the hub of the instrument.

In this embodiment of the invention there is a protector element (b) which may be largely flat and which when co-operating with holder element (a) substantially covers the recess in the holder element (a) and preferably has a depending bridge which co-operates with the bridge of element (a), the two co-operating bridges thereby contacting either the spine, cannula or the hub of the surgical instrument.

To prevent any substantial rotation of the ophthalmic instrument within the package one of the bridges can be provided with a recess to support the base of the instrument without touching the surgical surface of the instrument. In this manner instruments which are formed into shapes such as cystotomes can be prevented from rotating within the slot or channel of the bridge and so the surgical surface of the instrument is not brought into contact with the side of the package.

In order better to hold in place the hub of the instrument in the package it is preferred that in this embodiment the protector element (b) has a depending contoured flange which fits into the recess of holder element (a) and extends around the hub of the surgical instrument when located in position in the holder element (a). Preferably also the protector element (b) is provided with finger guides to enable easy removal from the holder element (a). Alternatively a flap could be provided on the protector element (b).

In the preferred embodiment of this invention the recess (c) is provided in the holder element (a). This recess is in the base of element (a) and extends laterally of the hub of the surgical instrument when located in position and allows the thumb and index finger or forceps to grip the hub easily and remove the surgical instrument from holder element (a).

There is a sealing film (d) to seal the co-operating elements (a) and (b) from the air. This can be plastics or a paper plastics laminate which is heat sealed to a flange on the periphery of element (a) so sealing the protective element (b) and the instrument from the external environment and contamination after sterilisation. In the preferred embodiment of this invention protector element (b) covers the recess in holder element (a). To facilitate this sealing the holder element (a) preferably has a flange around its recess and this flange has a shallow recess therein surrounding the recess in which the instrument is based. The protector element (b) is shaped so as to sit in this shallow recess.The sealing film or laminate is then attached to the flange of the holder element (a), preferably by heat sealing under pressure using heated rollers or dies, thereby enclosing the protective element (b) in the shallow recess in the flange of the holder element. Preferably the corners of the holder element are rounded to obviate sharp corners which could endanger sterility by puncturing other packages or surgical gloves.

The completed package comprising elements (a) and (b), recess (c) and film (d) can then be sealed in a secondary transparent envelope and subsequently be sterilised.

The pack can be opened in the surgical environment by removing the package (a),(b),(c) and (d) from the secondary envelope and peeling the film (d) from the elements (a) and/or (b). In the preferred embodiment protector element (b) can be removed by gripping the contoured shape of the hub retainer in protector element (b). In another preferred embodiment the finger guides in the protector element (b) can be used to remove the protector element (b) from the shallow recess in holder element (aj. These finger guides should not be located so that there is any risk of the fingers touching the surgical surface of the surgical instrument.

After removal of the protector element (b) the surgical instrument is exposed and it can be removed by holding the hub in the recess (c) without touching the surgical surface of the instrument.

The package of this invention is particularly suitable for packing the following instruments: capsulotomy instruments such as irrigating cystotomes; anterior chamber annulas; capsule polishers; capsule scrapers; capsule polisher curettes; cortex extractors; cannulas, such as U-shaped cannulas, aspirating cannulas, irrigating cannulas and side port cannulas; irrigating lens loops (vectis); intraocular lens positioners such as irrigating diallers and irrigating lens manipulators; and retrobulbar needles.

A preferred embodiment of this invention is now described with reference to the drawings in which: Fig. 1 shows an exploded view of a two part transparent blister of this invention; Fig. 2 shows a perspective view of the holder element housing an irrigating cystotome; Fig. 3 shows a side elevation of the protector element; and Fig. 4 shows a side elevation of the holder element.

Referring to Figs. 1,3 and 4, protector element 1 is shaped so as to fit into the shallow recess 2 of the holder element 3. There is a contoured recess 4 in the protector element 1 with a raised portion 5. When element 1 is inserted into element 2 this raised portion 5 surrounds the hub of the ophthalmic instrument. There is a recess 6 at the other end of the protector element 1 and this guides element 1 into the shallow recess 2 and also depends into the main recess 7 of the holder element 3. There are also finger guides 15 and 16.

The holder element 3 has a bridge 8 and a transverse slot 9 and a semi-circular recess 10. AT the other side of the bridge 8 there is a recess 11 (shallower than recess 7) and this in turn has another recess 12.

Referring to Fig. 2 an ophthalmic instrument 13 with a hub 14 is inserted in the holder element 2. The instrument 13 rests in the slot 9 of the bridge 8 and the hub 14 lies in the recess 11 above the recess 12.

For other instruments having a base between its surgical surface and its hub, location of the base in the semi-circular recess 10 prevents rotation of the instrument in the holder element 2.

The package or blister is assembled by placing the instrument 13 with its hub 14 in the holder element 3, inserting the protector element 1 in place in the recess 2. A thin plastics film or laminate (not shown) is then placed over the protector element 1 and heat sealed to the flange of the holder element 3.

Thereafter the package is sealed in a secondary transparent envelope (not shown).

To remove the instrument 13, the package is removed from the secondary transparent envelope, the thin plastics film or laminate is peeled from the holder element and the protector element 1 removed by use of the finger guides 15 and 16. The instrument 13 can be readily removed by gripping its hub 14 by inserting forceps or the index finger and thumb into the recess 12.

Claims (7)

1. A package for a surgical instrument which comprises packaging elements (a) and (b) which are capable of co-operating with one another so as to surround at least the surgical surface of the surgical instrument and so that when element (a) co-operates with element (b) the instrument at or near its hub is in contact with both elements and is gripped by at least one of the elements so that the surgical surface of the instrument does not contact either element (a) or element (b), a recess (c) provided in one of the elements (a) and (b) to allow access of the fingers or forceps to the hub of the instrument when the elements (a) and (b) no longer co-operate with one another and a sealing film or laminate (d) to seal the co-operating elements (a) and (b) from access to the air.

2. A package according to claim 1 in which elements (a) and (b) are separate elements.

3. A package according to either of claims 1 and 2 in which element (a) is a holder element provided with a recess to house the surgical instrument, a bridge substantially transverse to the longitudinal axis of the instrument to be housed, said bridge having a transverse slot or channel shaped to receive and grip the hub of the instrument or the spine of the instrument near its hub.

4. A package according to claim 3 in which element (b) is a protector element which when co-operating with holder element (a) substantially covers the recess in the holder element (a) and which has a depending bridge to co-operate with the bridge of holder element (a).

5. A package according to claim 4 in which the protector element (b) has a depending contoured flange which fits into the recess of holder element (a) and extends around the hub of surgical instrument when located in position in the holder element (a).

6. A package according to any one of claims 3 to 5 in which the recess (c) is provided in the base of the holder element (a) and the recess (c) extends laterally of the hub of the surgical instrument when located in position.

7. A package for a surgical instrument substantially as hereinbefore described with reference to the drawings.