Surgery – Instruments – Suture – ligature – elastic band or clip applier
Reexamination Certificate
1999-02-25
2001-07-03
Recla, Henry J. (Department: 3731)
Surgery
Instruments
Suture, ligature, elastic band or clip applier
Reexamination Certificate
active
06254616
ABSTRACT:
The present invention relates to a suture container, and particularly a contain comprising a spool onto which a length of suture material may be wound and then sterilized and packaged for sale. The suture container is particularly suitable for use by veterinary surgeons.
Veterinary surgeons have traditionally used catgut for suturing. It has been the practice to supply a substantial length (e.g. 50 meters) of catgut wound onto a spool in a contained filled with alcohol, usually isopropanol. One end of the suture protrudes through an orifice in a rubber septum, so that the veterinary surgeon can withdraw the desired length of suture from the spool, while maintaining sterility within the container.
More recently, the move has been towards synthetic sutures, and particularly absorbable sutures formed from biodegradable lactide/glycolide polymers such as Vicryl® polymer. The traditional dispensers are now is use for absorbable sutures, but there are a number of disadvantages. In particular, there is a risk that moisture will enter the dispenser, leading to degradation of the polymer. Partial degradation of a length of suture material will substantially reduce its tensile strength, but this may not be apparent merely from visual inspection of the suture. Accordingly, the tissue of the patient may be ligated with unsuitable suture material, and the suture may break down before the tissue heals. Also, the known containers are cumbersome and relatively heavy.
It is the object of the present invention to provide a suture container that avoids the above disadvantages.
According to the present invention, there is provided a suture container having a spool rotatably mounted therein, and a length of suture material wound on said spool, said container being wrapped in an outer bacteria-proof envelope. Preferably, the container comprises a first portion and a second portion, and the spool is rotatably mounted between the first and second portions. The first and second portions may be hingedly attached to each other. In a particularly preferred embodiment, the first and second portions are hingedly attached for relative movement about an axis which is parallel to the axis of rotation of the spool. However, it will be appreciated that the first and second portions may be attached to each other in a variety of alternative ways.
The container is preferably made from a plastics material, such as polypropylene, high density polyethylene (HDPE) or low density polyethylene (LDPE). Polypropylene is particularly preferred.
The spool may comprise a hub and two discs mounted thereon. Suture material, preferably up to about ten meters long, and more usually between 2 and 6 meters long, may be wound onto the hub between the two discs. The discs are preferably made from a plastics material, so as to minimize friction between the suture material and the discs when the suture is wound onto or withdrawn from the spool. Suitable plastics include polyvinylchloride and polyethylene terephthalate G. In general, the discs will be between 0.1 and 0.8 mm thick, and preferably between 0.25 and 0.6 mm thick. For example, the discs may be 0.3 or 0.5 mm thick.
It is particularly preferred that the discs be transparent or translucent. The expression “transparent or translucent”, as used herein, is intended to cover discs which are sufficiently transparent or translucent for the suture material to be discernible through the discs. This has two particular advantages. Firstly, it is of assistance during assembly of the containers for sale, because it allows the operator to check than an appropriate amount of suture material has been properly wound onto the spool. Secondly, when the container itself is also transparent or translucent, or suitable apertures are provided in the sides of the container, it allows the user to judge how much suture material remains on the spool.
Although transparent plastic discs are preferred, it is also possible to form the discs from card, such as Invercote S, Cropper Board or Monadock card. In such a case, it may be desirable to provide the card with a reduced friction coating, such as a coating of polytetrafluoroethylene (PTFE).
In a preferred embodiment, the hub is provided with means for receiving one end of a length of suture material, to assist in winding the suture material onto the spool. Such means preferably comprises a slot or groove, and more particularly a slot arranged orthogonal to the axis of rotation of the hub.
The suture is preferably bioabsorbable, and may be made from lactide/glycolide polymer. Alternatively, however, the suture may be non-absorbable. For some surgical applications, a suture formed from stainless steel wire may be appropriate.
The bacterial-proof envelope may be made from any suitable material, such materials being well-known in the suture packaging art. Preferably, the envelop is formed from an aluminized plastics laminate, such as a Surlyn or Mylar foil. Most preferably, the bacterial-proof envelope is heat-sealed around its periphery, but adhesives may alternatively be used.
The suture container and suture are preferably sterilized using ethylene oxide, as is conventional with sutures intended for human use. However, alternative sterilization techniques may also be used, including &ggr;-irradiation and autoclaving, provided that suitably resistant materials are chosen for the suture and the components of the container.
The suture container with a length of suture material wound on the spool will generally be placed inside the envelope prior to sterilization. If a gaseous sterilization medium such as ethylene oxide is being used, the envelope is of course left unsealed until after sterilization. Moreover, the container is preferably provided with a number of apertures in the walls thereof, to increase exposure of the suture material to the gaseous sterilant.
If ethylene oxide is used for sterilization, the suture and the container are first subjected to a pre-humidification step. A cardboard insert may be included in the envelope to absorb moisture during pre-humidification, and to retain moisture during exposure to ethylene oxide. The cardboard insert may be attached to the suture container, and it may bear graphical or textual material, such as instructions for use of the suture.
A suture container according to the present invention provides a conveniently small and sterile package from which a require length of suture material may be taken by a veterinary surgeon. Since, in the preferred embodiment, a comparatively short length of suture material is contained on the spool, it is anticipated that the container will be used on a disposable basis, i.e. once the container has been opened, the required amount of suture is used, and the container is then discarded. In this way, there is no risk of premature breakdown of the suture material due to storage of an opened container in an unsuitable environment.
REFERENCES:
patent: 3901244 (1975-08-01), Schweizer
patent: 3959947 (1976-06-01), Sommino
patent: 4084692 (1978-04-01), Bilweis
patent: 5131534 (1992-07-01), Brown et al.
patent: 5156311 (1992-10-01), Spencer, Jr.et al.
patent: 0 557 993 A1 (1994-12-01), None
patent: 1 369 178 (1974-02-01), None
Bui Vy Q.
Emil Richard Skula
Ethicon Inc.
Recla Henry J.
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