GB2514994A - Suture packages - Google Patents

Abstract

Suture packages are described which have a plastics base unit defining a circular or elongate track for receiving a suture thread. The track is formed between two generally flat components 1, 2 which may be fixed together to define the track and where the periphery of one of the components is formed 10 of a resilient flexible edging material 15 configured to lie against the other of the generally flat components to define the outer edge of the channel containing the suture. One of the moulded plastics components may have formations moulded therein adapted to constitute a needle park for the needle of an armed suture. The needle park preferably consists of two spaced apart stop members and a resiliently mounted arm having an end adapted to press a needle bridging the two stop members against those two stop members, and wherein the end of the arm is movable to enable insertion of a needle into, or removal of a needle from, the needle park in a direction parallel to the plane of the track.

Description

SUTURE PACKAGES

This invention relates to suture packages and in particular to improved designs enabling simpler manufacture and providing advantages to the user.

While a variety of suture packages have been proposed in the patent literature, and used in practice, the most widely-used suture packages consist of a moulded plastics construction, usually of two parts, defining a track around which the suture passes in a number of turns and with the end of the suture carrying a needle, i.e. the suture is armed. The needle is located by means of a so-called needle park formed in the plastics moulding.

The needle park is conventionally covered by a thin plastics or card cover sheet which may bear details relating to the suture in question, such as the type of suture and size of needle, and the entire arrangement is customarily presented in a sealed enclosure which can be subject to sterilisation after assembly.

Examples of disclosures of such suture packs are to be found in the following

published specifications:

US-A-6 135385, DE-A-i 10904380, JP-A-2001 137250, US-A-2004/01 77594, US-A-604781 5, EF-A-1 475046, US-A-5271 495, US-A-5655652, US-A- 5906273 and EP-A-1 354796.

US-A-5131 533 and US-A-Si 80053 both disclose specific needle park constructions which can be used in suture packages, and other needle park arrangements are disclosed in EP-A-0607051, US-A-5788062, US-A- 5655652, US-A-5704469, US-A-5906273 and US-A-5503266.

US-A-2004101 77594 discloses in particular how an armed suture may be loaded into the suture package. It describes how, by the use of a winding system, a suture may be wound about the elongate track. After placing the lead end of the suture in the package, for example by hand or using a robot, and usually simply by locating the needle of an armed suture in the needle park formed in the package component, the package is then rotated about an axis perpendicular to the plane of the track and fed into it using a so-called stylus which is adapted to open and close sections of the track as the track is rotated. As can be seen from the drawings in this specification, both the machine and the construction of the suture pack components are complex.

The feeding in of the suture to the track by lifting up a series of tabs covering the top of the track is not the only way of configuring a closable track.

US-A-C 135385 discloses a suture package where the suture may be pulled into the track by turning an arrangement formed of two panels of flexible hard sheet material fixed to one another and having divergent rim strips which constitute a V-shaped groove through the bottom of which the suture slips as the package is rotated. The resilience of the flexible hard sheet material allows this to occur and leaves the suture thread itself protected within a suture channel until it is withdrawn by grasping the needle and pulling. It may then simply be withdrawn from the channel and used as desired, e.g. by a surgeon.

An alternative arrangement is shown in EF-A-1 475046 where a winding channel is defined by side walls, at least one of which can be pivoted relative to the other to move the winding channel into an open state enabling the suture to be wound into it. The side wall can then be flipped back into a closed position to enclose and protect the suture itself.

According to a first feature of the present invention, a suture package includes a plastics base unit defining a circular or elongate track for receiving a suture thread, the track being formed between two generally flat components which may be fixed together to define the track and where the periphery of one of the components is formed of a resilient flexible edging material configured to lie against the other of the generally flat components to define the outer edge of the channel containing the suture.

According to a second feature of the present invention, there is provided a suture package including a moulded plastics component defining at least part of a flat, circular or oval track around which a suture may be wound, and having formations moulded therein adapted to constitute a needle park for the needle of an armed suture, wherein the needle park consists of two spaced apart stop members and a resiliently mounted arm having an end adapted to press a needle bridging the two stop members against those two stop members, and wherein the end of the arm is movable to enable insertion of a needle into, or removal of a needle from, the needle park in a direction parallel to the plane of the track. Preferably the free end of the arm can move about an arc, i.e. it can rotate a little, with flexure of the arm, about an axis at the foot of the arm and perpendicular to the plane of the track.

By constructing a needle park in this way, it is possible to accommodate, with one and the same moulded plastics base component, a wider variety of needle sizes than in known packages where the moulding may need to be different for different sized needles. By suitable design of the arm itself and choice of the plastics for the moulding, the resilience may be sufficient to hold a wide variety of needles firmly against the projecting stop members.

Preferably the projecting stop members have an indentation in them in which the side of the needle may rest and the end of the arm may likewise have an indentation so holding the parked needle between the three indentations in a plane which is parallel to but spaced from the floor of the plastics component from which the projections rise and in which the arm is also moulded.

Both features of the invention are present in an exemplary embodiment of a suture package illustrated in detail in the accompanying drawings. It will be apparent, however, that each of the features of the present invention may be used by itself in suture packages and, in particular, that the approach to forming a needle park may be useful in simpler suture package constructions which do not necessarily have a circular or elongate track.

In the accompanying drawings, the suture pack is shown without the normal package or envelope in which it is supplied for use, and into which it is placed after the suture has been loaded into it, sterilised and sealed.

In the drawings: Figure 1 is an exploded perspective view of a first embodiment of a suture package in accordance with the present invention; Figure 2 is a view of the two lower components of the package shown in Figure 1 on a larger scale; Figure 3 is a view of the lower components of the package shown in Figure 1 from below; Figure 4 is a view of the two lower components of the package shown in Figure 1 assembled together; Figure 5 is a view of the assembly of Figure 4 from the underside; Figure 6 is a perspective view showing the detailed construction of the needle park in the suture package; Figure 7 is a view of a section of the assembly shown in Figure 4 cut along the lines 7-7; and Figure 8 is a view of a section of the assembly cut along the lines 8-8 in Figure 4.

Referring to the drawings, the suture pack consists of three main components, viz, a central section 1, a lower section 2 and a cover sheet 3.

The central section holds a needle 5 which is attached to one end of a suture 4. The lower section 2 is in the form of a generally flat moulded portion 10 having eight upstanding tabs 11 which can clip into eight corresponding slots 12 in the central section. Central section 1 and moulded portion 10 are of relatively rigid plastics material, for example of rigid polypropylene. Moulded on to the periphery of portion 10 is a flexible rubbery skirt 15. When the central section 1 and lower section 2 are clipped together, they define a channel 18 for receiving the suture 4. The upper side of the central section 1, as shown in Figure 1, has three moulded posts 19 with a central rectangular cavity 20 in each and the cover sheet 3 has three tabs 21 in it so that sheet 3 can be press fitted into the posts 19. Each tab 21 is resilient and the free edge of the tab locates under a ledge formed near the top of the outer edge of each cavity.

an alternative way of fixing sheet 3 on to section 1 is to provide moulded posts on section 1 and corresponding holes in sheet 3; once the sheet 3 is located on the posts, the top of each post can be deformed or heated to seal on to sheet 3 and hold it firmly in place.

The lower side of central section 1 also has a number of short arcuate walls 17 around each of the curved ends of the track which are a press fit into a set of holes 23 in lower section 2, and which surround a corresponding set of holes 24 in central section 1.

Moulded into central section 1 is a thin slot 25 defining a tab which can be pushed upwards or downwards. Lower section 2 has a hole 26 in it to enable this to occur. When the suture is needed for use, the tab defined by slot 25 may be pushed downwards and the needles grasped using a pair of forceps with the jaws located either side of the needle at the position marked A on Figure 4. Alternatively, the tab may be pushed upwards by inserting a fingertip into hole 26 which causes the edge of the tab to push the needle 5 upwards out of the plane of the package so it can be easily grasped by a pair of forceps.

Moulded in central section 1 are two needle parks, each of which consists of an arm 30 and a generally V-shaped wall 31. Because of the resilience of the material from which the central section is moulded, the end of each arm 30 can be displaced and will tend to return resiliently so that it describes a small arc identified by the double-headed arrow 32 shown in Figure 6. The ends of the V-shaped wall sections 31 are slightly concave as shown on Figure 6 at 33 and the end of arm 30 has a relieved area 34 so that a needle 5 may be firmly gripped if it is simply pushed into the needle park in standard fashion.

The tops of wall sections 31 and arms 30 as shown in Figure 6 are rounded to enable the needle to be inserted easily.

Both the central portion 1 and the lower portion 2 have apertures 40 and 41 respectively which enables the clipped-together assembly to be mounted on a winding table which is then rotated about a vertical axis in order to wind the suture into the track 18. The winding table also has a set of ten posts which enter apertures 23 and 24. Insertion of the needle 5 into the needle park may be facilitated in practice by moving the arm 30 away from the wall sections 31 by formations on the winding table (see below) which engage arms 30.

Lower section 2 has an aperture 28 through which the projections pass when the assembly is placed on the winding table. In order for the suture 5 to be able to enter the track 18, there is an aperture 45 on the outer edge of central section 1 adjacent the needle parks. In order to load a suture into the assembly of central section 1 and lower section 2, the needle 5 is first placed in the needle park and the suture led into the track 18, while the edge of the outer skirt 15 is held down using a suitable stylus. During the winding process, the suture is held slightly away from the inner wall of track 18, as it is wound round the rounded ends of the track 18, by the ten posts on the winding table located in apertures 23, 24. The technique of winding a suture on to such a track using a stylus is disclosed in US-A-2004/0177594. The rotation of the assembly is carried out until the entire length of the suture 4 is located in track 18, whereafter the stylus is withdrawn and the edge of the flexible skirt 15 then lies in contact with the edge of central section 1 around its entire periphery save for the aperture 45. The suture lies loosely in track 18 following the withdrawal of the posts on the winding table when the assembly is removed from the table. Removal of the assembly also allows arms 30 to move slightly towards wall sections 31 to hold the needles firmly in position.

Following removal, the cover sheet 3 may be press4itted into place. Cover sheet 3 may bear printing or an embossed marking identifying, for example, the nature of the suture, the size of the needle and other data, such as the manufacturer's name, suture identifier and any other appropriate useful information.

The entire unit may then be placed in an enclosure, for example a plastics film or plastics laminate enclosure, and sterilised in standard fashion, for example by injecting ethylene oxide into the package and then sealing it.

As can be seen in detail in Figures 7 and 8, the cross-sectional contour of the flexible rubbery skirt 15 is rounded, which assists flexing the skirt during the winding process. This flexing is also assisted by a slight vertical offset between the underside of the lower section of the package, denoted 50 in Figure 7, and the flat underside of the rubbery skirt denoted 51 in Figure 7.

The difference in level may be, for example, around 0.2 mm. additionally, the external periphery of the skirt 15 lies slightly set back from the external periphery of the central section 1, which avoids the skirt 15 catching on anything as the package is handled, and the edges of the skirt and the periphery of the central section 1 are castellated so that, in the assembled package, they mesh with one another. This materially reduces the possibility that, during handling, the end of the suture 4 may spring out of the gap between skirt and centre section 1.

Most clearly visible in Figures 2, 3 and 7 is a set of recesses 56 on the edge of track 18 and a set of matching posts 58 on moulded portion 10. When the central and lower sections are fitted together, these posts and recesses reduce the risk of the suture jamming in the corner of the track when the two sections adjoin, as shown in Figure 7.

Claims (9)

1. CLAIMS1. A suture package includes a plastics base unit defining a circular or elongate track for receiving a suture thread, the track being formed between two generally flat components which may be fixed together to define the track and where the periphery of one of the components is formed of a resilient flexible edging material configured to lie against the other of the generally flat components to define the outer edge of the channel containing the suture.
2. 2. A suture pack according to Claim 1 wherein the two generally flat components are of a relatively rigid plastics material and the resilient flexible C') 15 edging is a flexible rubbery sheet mounted on to one of them.
3. 3. A suture pack according to Claim 2 wherein the resilient flexible edging r and the flat component against which it lies are castellated.LU r
4. 4. A suture pack according to Claim 2 or 3 wherein the external periphery of the skid is set back from the external periphery of the flat component against which its edge lies.
5. 5. A suture package including a moulded plastics component defining at least part of a track around which a suture may be wound, and having formations moulded therein adapted to constitute a needle park for the needle of an armed suture, wherein the needle park consists of two spaced apart stop members and a resiliently mounted arm having an end adapted to press a needle bridging the two stop members against those two stop members, and wherein the end of the arm is movable to enable insertion of a needle into, or removal of a needle from, the needle park in a direction parallel to the plane of the track.
6. 6. A suture package according to Claim 5 wherein the free end of the arm can move about an arc, i.e. it can rotate a little, with flexure of the arm, about an axis at the foot of the arm and perpendicular to the plane of the track.
7. 7. A suture package according to Claim 5 or 6 wherein the projecting stop members have an indentation in them in which the side of the needle may rest.
8. 8. A suture package according to any one of Claims 5 to 7 wherein the end of the arm has an indentation for holding the parked needle in a plane which is parallel to but spaced from the floor of the plastics component from which C') 15 the projections rise and in which the arm is also moulded.
9. 9. A suture package according to any one of Claims 5 to 8 and additionally r. . configured according to any one of Claims 1 to 4.LU r