WO2012071610A1

WO2012071610A1 - Surgical scalpel tray

Info

Publication number: WO2012071610A1
Application number: PCT/AU2011/001549
Authority: WO
Inventors: Andrew Thompson
Original assignee: Hodei Pty Ltd
Priority date: 2010-12-02
Filing date: 2011-11-29
Publication date: 2012-06-07

Abstract

A tray to accommodate sharp surgical instruments or for their safe passing during surgical procedures, said tray incorporating a narrow, elongated, parallel-sided, medially-located instrument channel raised above a supporting surface on peripheral flanges and enclosed by raked side and end walls which act to deflect a deposited instrument into said channel; said peripheral flanges terminating at a finger well which medially transects said instrument channel, extends transversely across more or less the full width of said tray and is of an axial width to comfortably accommodate the fingers of a user grasping a surgical instrument lying in said instrument channel; the lower surface of said finger well abutting the supporting surface and acting to stabilise the position of said tray; an outwardly extending, more or less horizontal flange being provided passing fully around the upper edge of said tray to stiffen said tray and facilitate grasping of it.

Description

SURGICAL SCALPEL TRAY

This invention relates generally to receptacles employed in the surgical environment In particular, it relates to trays or receptacles employed in the surgical environment as repositories for or the passing of surgical sharps.

In the surgical environment, it is usual for sharp surgical implements, when not in use, to be deposited in suitable sterile trays from which they may readily be retrieved when required. Given the danger of cutting or puncture injuries inherent in the handling of sharp instruments, the possibility of infection from the same and the compromising of asepsis, it is also normal for surgical sharps, as they are referred to, to be passed to a user in a tray, rather than simply being picked up and passed from hand to hand, as was once the practice. The use of open-topped kidney dishes for this purpose is quite unsatisfactory, with instruments being poorly located, gloved fingers being ill-adapted to grasp an object of compact cross-sectional shape lying on a flat surface and with the attendant possibility of cutting or puncture injury. To overcome these shortcomings, trays have been designed for use specifically as receptacles or for the passing of surgical sharps. An example is that taught by Cavanagh in US

6,065,596 (A) and marketed by Daniels Healthcare Ltd, of Kidlington, Oxon, OX5 1 JD, United Kingdom, under the brand name, Bladesmart. This invention is intended to hold instruments having a handle portion and a cutting portion during surgical procedures. It comprises an elongated, narrow instrument recess at the centre of which is provided a finger access recess, the floor of which is located below that of said instrument recess to facilitate gripping of an instrument. Said instrument and finger access recesses are surrounded at the sides and ends by sloping walls which direct an instrument dropped into said tray into said instrument recess. The upper edges of said sloping side and end walls are joined to the upper edges of more or less vertical side and end walls, on the lower edges of which the invention is supported. This tray is wasteful in its use of material, effectively having separate inner and outer structures, and is poorly adapted to grasping by a user. Another example is that taught by Sandel in US 2006/0042977 Al and marketed by Sandel Medical Industries, LLC, of Chatsworth, CA 91311 , USA, under the brand name, Z-Tray. This invention is similarly intended to hold sharp surgical instruments during surgical procedures. It comprises inner and outer walls enclosing a relatively broad floor raised locally by two or more transverse ribs. Said ribs facilitate gripping of an instrument by supporting it above said floor and inwardly projecting protrusions of the side inner walls act to maintain the instrument clear of said side walls. The lower edges of said outer walls are formed into outwardly projecting flanges upon which said tray is supported. Finger recesses are formed on the bottom of the tray to allow the tray to be easily grasped and held from below. The ends of said tray are optionally narrowed and provided with grip ridges to facilitate grasping. Handles are optionally formed at the ends of said tray to also facilitate grasping. An adhesive or magnetic strip or element is optionally provided on the bottom of said tray to hold it to a surgical drape or other surface and said tray is optionally made telescopically extendible. This tray is similarly wasteful in its use of material, also effectively having separate inner and outer structures. Except where said handles are formed on its ends, said tray is also relatively poorly adapted to grasping by a user. Another example is that taught by Hoftman in US 7,441,655 Bl and marketed by Purple Surgical, of Shenley, Herts, WD7 9 AD, United Kingdom. This tray is a dual function transfer tray that can be used to accommodate either a scalpel or suturing needle holder with suturing needle. A scalpel slot is formed in the bottom of a relatively deep set of sloped inner walls. A suture needle cavity is formed above the first slot. However, at a mid-section of the scalpel slot and the half-cylindrical suture needle cavity are opposing and deep V- shaped cutaway sections in the sidewalls with a flat floor section between them. This facilitates location by a user of the mid-section of the transfer tray, the user's thumb and forefinger being directed by the V-shaped sidewall openings to grasp a midsection of a supported surgical sharp. The scalpel slot and half-cylindrical suture needle cavity are set relatively deeply with respect to the top edges of the transfer tray and thereby prevent a user from being inadvertently injured by a scalpel blade or a suture needle. Additionally, the scalpel cannot be placed in the scalpel slot unless it rests on one of its longitudinal edges, preferably the same one as that of its blade edge. Thus, a user grasping the mid-section of the scalpel handle in the cutaway and flat floor section picks up the scalpel in a ready-to-use position. Two trays may be joined to allow safe, hands-free transfer of multiple instruments. Said sloped inner walls are surrounded by outer walls, the lower edges of which are formed into outwardly projecting flanges upon which said tray is supported and which incorporate means for joining trays. Similarly also, this tray is wasteful in its use of material, effectively having separate inner and outer structures, and is poorly adapted to grasping by a user. Another example is that taught by Horan et al in US 5,339,955 and marketed by Devon Industries, Inc, of Chatsworth, California, USA. This is a medical instrument tray having a frame of opposing side and end walls with inner and outer panels.

Instrument supports extend across the frame and join to inner panels of the side walls. The instrument supports have pegs separated by a central plateau, radiused sections for supporting round instruments, and slots for supporting a flat handle instrument such as scalpel. Finger slots are provided on the bottom side of the tray to allow the tray to be easily carried with the fingers away from the sharp edges or points of the instruments. Metal plates or strips are optionally bonded onto the bottom surface of the tray to allow it to be held onto a magnetic drape commonly used in surgery.

Similarly, for use with cloth drapes, a high friction, non-skid material may be applied to the bottom of the tray. The outer panels of the side walls of the tray are bowed outwardly at the center of the tray frame and are easily grasped and carried by inserting a thumb and one or more fingers into the opposing finger slots so formed. Similarly also, this tray is wasteful in its use of material, effectively having separate inner and outer structures. Its grasping slots are not readily accessed with the tray resting upon a hard surface and are therefore poorly adapted to grasping by a user. Importantly, the tray provides poor protection to the user from cutting or puncture injury. It will be readily understood that, as such trays are used in large numbers and are single-use, disposable items, their cost is a significant consideration. Economy of material use is thus an important factor in their design.

The object of the present invention is to provide a tray for the secure and sterile resting of sharp surgical implements in the surgical environment and for the passing of such instruments during surgical procedures, said tray being stiff, stable when resting upon a supporting surface, comprising only a single structure for economy of material usage, providing good protection to users from cutting or puncture injury and being easily grasped and securely handled.

According to the present invention, a tray to accommodate sharp surgical instruments or for their passing during surgical procedures comprises a narrow, elongated, medially-located instrument channel to accommodate a scalpel or the like, said channel being transected at mid length by a finger well passing transversely across the full width of said tray. Said finger well is of sufficient axial length to comfortably accommodate the fingers of a user grasping a surgical instrument lying in said instrument channel and its lower surface abuts the supporting surface. To facilitate the grasping of said surgical instrument, the floor of said instrument channel is raised above the floor of said finger well on flanges which pass fully around the edges of said channel to either side of said finger well and bear against the supporting surface. The side walls of said tray to either side of said finger well are raked to positively deflect a deposited instrument into said channel and the end walls of said tray are optionally raked in a manner similar to said side walls or are stepped for specific purposes. An alternative embodiment of said instrument channel and said finger well is provided. Provisions are made to warn the user against intrusion of fingers into the interior of said tray. Provisions are also made to locate said finger well by touch and to support or attach said tray to surfaces. A handle is provided as an alternative means of lifting said tray.

The various aspects of the present invention will be more readily understood by reference to the following description of preferred embodiments given in relation to the accompanying drawings in which:

Figure 1 is an isometric view from above of a first embodiment of said surgical instrument tray;

Figure 2 is an isometric view from below of the surgical instrument tray of Figure 1;

Figure 3 is a view from above of the surgical instrument tray of Figure 1 ; Figure 4 is a side view of the surgical instrument tray of Figure 1 ;

Figure 5 is a diagrammatic, longitudinal cross-sectional view of the surgical instrument tray of Figure 1 ;

Figure 6 is a fragmentary, longitudinal cross-sectional view through a vertical plane of an alternative embodiment of an end of the surgical instrument trays of Figures 1 and 7;

Figure 7 is an isometric view from above of a second embodiment of said surgical instrument tray;

Figure 8 is a view from above of the surgical instrument tray of Figure 7; Figure 9 is a diagrammatic, longitudinal cross-sectional view of the surgical instrument tray of Figure 7;

Figure 10 is a fragmentary view from above of an alternative embodiment of an end of the surgical instrument trays of Figures 1 and 7;

Figure 1 la is a view from above of attachment means of said surgical instrument tray;

Figure 11 b is a side view of the attachment means of Figure 11a.

With reference to Figures 1, 2, 3, 4 and 5, a tray 1 to accommodate sharp surgical instruments or for their passing during surgical procedures comprises a narrow, elongated, medially-located instrument channel 2 to accommodate a scalpel or the like 3, said channel being transected at mid length by a finger well 4 passing transversely more or less across the full width of said tray. Said finger well is of sufficient axial length to comfortably accommodate the fingers of a user grasping a surgical instrument lying in said instrument channel and its lower surface 10 abuts the supporting surface. Said channel is made sufficiently deep to protect the fingers of a user from the sharp parts 13 of said surgical instrument. To facilitate the grasping of said surgical instrument, the floor of said instrument channel is raised above the floor of said finger well on flanges 5 which pass fully around the edges of said channel to either side of said finger well and which bear against the supporting surface. The side walls 6 of said tray to either side of said finger well are raked to positively deflect a deposited instrument into said instrument channel and, in a first preferred embodiment, the end walls 7 of said tray are raked in a manner similar to said side walls. Joined to the upper edges of said side and end walls is circumferential flange 8 which passes fully around said tray, acting to stiffen said tray when made from thinner material and providing a surface which may be readily and securely grasped. In an alternative embodiment (not shown), the surfaces of said circumferential flange are made suitably textured or ribbed to allow the fingers of a user to more positively grasp them. Suitable pads 9 are optionally provided on the upper surfaces of said circumferential flange for the printing or moulding of text or decoration. In another alternative embodiment (not shown), the free edge of said circumferential flange to a width of between 3 and 6 millimetres is turned upwardly or downwardly through an angle of between 60° and 90°, thereby providing additional stiffness and allowing the fingers of a user to more positively grasp said flange. In another alternative embodiment (not shown), said circumferential flange is made the same thickness as the generality of said tray or up to five times thicker. To provide stability of said tray when resting upon a surface, said finger well is made wider than the transverse distance between the upper edges of said raked side walls such that it intrudes substantially into the width of said circumferential flange. In the preferred embodiment, the ratio of the width of the upper edge of said finger well to the transverse distance between the upper edges of said raked side walls falls in the range 1.2: 1 to 1.5 : 1.

In a second preferred embodiment, one or both of the end walls of said tray are made with an intermediate step 11 separating the upper part of an end wall (depicted as 7a in Figure 6) from the lower part of an end wall (depicted as 7b in Figure 6). In this embodiment, said end wall upper part is preferably made substantially vertical and said end wall lower part is preferably made curved and raked in a manner similar to said side walls. Said step is optionally made substantially horizontal or sloping inwardly at an angle between 5° and 30°. Where said step is employed as a rest for the handles of forceps, scissors or the like, suitable lugs 12 are optionally provided on it to retain said handles in place. In a third preferred embodiment to provide greater stability of said tray on a supporting surface, end wall upper part 7a is extended downwardly to create skirt 14, the lower edge of which bears upon the supporting surface. In order to provide a haptic warning to a user of the inner edge of circumferential flange 8 and thereby to minimise the possibility of intrusion of a finger or thumb of the user into the interior of said tray, a raised edge 15 is provided around the full inner edge of said flange. To permit finger well 4 to be located by touch, said raised edge is also provided along the side edges 16 of said finger well and the height of this part of said raised edge is optionally made from 2 to 4 times greater than the height of the generality of said raised edge. In an alternative embodiment (not shown), where skirts 14 are deleted, the stability of said tray while resting upon a supporting surface is enhanced by the provision of stabilisers. In a first embodiment, said stabilisers optionally take the form of skirts similar in form to skirts 14, their inner ends having inwardly directed lugs or flanges which slidingly engage complementary channels formed in the side surfaces of flanges 5. In a second embodiment, said stabilisers take the form of transverse bars, said bars having pairs of curved arms which enclose the ends 16 of flanges 5, lugs or detents formed on the ends of said arms engaging complementary detents or lugs formed on the side surfaces of flanges 5. Said stabilisers are optionally permanently attached to said tray in a post-manufacturing process or are made in clip-on, detachable form. The delayed attachment of said stabilisers permits closer stacking of multiple said trays (without stabilisers) for the purposes of packing and transportation. To further facilitate close stacking of said trays, all surfaces abutting during stacked arrangement are made with suitable draft angles. In the preferred embodiment, the side exterior surfaces 17 of said finger well and the side exterior surfaces of 18 of said end wall upper parts are suitably ribbed or textured to allow the fingers of a user to more positively grasp them. In the preferred embodiment, the lateral exterior faces 19 of said finger well are made flat or slightly convex and are adapted for the printing or moulding of text or decoration. In an alternative embodiment, a handle stem 20 has at its distal end a transversely arranged bar 21 to which are fixed two or more curved engagement elements 22. To lift said tray, said engagement elements are passed downwardly through suitable apertures provided in circumferential flange 8, the free ends of said elements abutting the underside of said flange as said handle stem is lifted.

With additional reference to Figures 7, 8 and 9, the floor of instrument channel 2 is made coplanar with the floor of finger well 4 and a plurality of raised ribs 23 are provided passing transversely across said instrument channel. Said ribs raise a surgical instrument resting in said channel above the floor of said finger well, thereby facilitating the grasping of said instrument. In other respects, the embodiment conforms generally to the description given in relation to Figures 1 to 5.

With additional reference to Figure 10, in an alternative embodiment in which shelf 11 is provided in one or both ends of said tray, raked sides 6 transition via raked, curved surfaces 24 to raked, curved end wall lower part 7b.

With reference to Figures 11a, l ib, one or more attachment tabs 26 are fixed to flanges 5, said tabs being optionally provided with keyhole apertures to engage complementary lugs, adhesive pads, areas of magnetic material, areas of one or other part of the Velcro® attachment system, or the like. In this embodiment, each said tab is fixed to a transverse bar 28 on which are formed two or more split lugs 25. Said tabs are fixed to flanges 5 by passing said split lugs through complementary apertures therein, the heads of said split lugs expanding to engage said flanges.

Said tray is preferably made from any suitable, rigid polymer material adaptable to sterilisation by the gas or radiation methods well known in the art. Such sterilisation methods include ethylene oxide and gamma radiation. As said tray is a disposable item, biopolymer materials are particularly suitable for its manufacture. Where a said tray manufactured from a biopolymer material unsuitable for gas sterilisation is to be included in a surgical pack to be sterilised by gas sterilisation, said tray is first sealed in a suitable polymer film enclosure and sterilised by gamma radiation.

No meaning should be inferred from the fact that the figures are drawn to different scales.

The present invention should be taken to include any feasible combination of any one disclosed feature with any other disclosed feature or features.

Claims

1. A tray to accommodate sharp surgical instruments or for their safe passing during surgical procedures, said tray incorporating a narrow, elongated, parallel- sided, medially-located instrument channel raised above a supporting surface on peripheral flanges and enclosed by raked side and end walls which act to deflect a deposited instrument into said channel; said peripheral flanges terminating at a finger well which medially transects said instrument channel, extends transversely across more or less the full width of said tray and is of an axial width to comfortably accommodate the fingers of a user grasping a surgical instrument lying in said instrument channel; the lower surface of said finger well abutting the supporting surface and acting to stabilise the position of said tray; an outwardly extending, more or less horizontal flange being provided passing fully around the upper edge of said tray to stiffen said tray and facilitate grasping of it; pads for the displaying of decoration and/or text being optionally provided on the outer lateral surfaces of said finger well and the upper surface of said flange; enlarged skirts abutting the supporting surface optionally being provided surrounding the ends of said instrument channel to better stabilise the position of said tray; the whole forming, effectively, a single-walled structure.

2. The tray of Claim 1 in which the depth of said instrument channel is such as to protect the fingers of a user from the sharp parts of a surgical instrument accommodated therein.

3. The tray of Claim 1 in which the difference in height of the floor of said instrument channel and the height of the floor of said finger well is such as to facilitate grasping of a surgical instrument accommodated therein.

4. The tray of Claim 1 in which the surfaces of said horizontal flange are textured or ribbed to permit them to be more securely grasped.

5. The tray of Claim 1 in which the free edge of said horizontal flange to a width of between 3 and 6 millimetres is turned upwardly or downwardly through an angle of between 60° and 90° to provide additional stiffness or to permit said flange to be more securely grasped.

6. The tray of Claim 1 in which said horizontal flange is made with the same thickness as the generality of said tray or up to 5 times that thickness.

7. The tray of Claim 1 in which the ratio of the distance between the upper, lateral edges of said finger well to the distance between the upper, lateral edges of said raked side walls falls in the range 1.2 : 1 to 1.5 : 1.

8. The tray of Claim 1 in which said tray end walls are made with an intermediate step separating an outer, upper part, which is made substantially vertical, from an inner, lower part which is made curved and raked in a manner similar to said side walls.

9. The tray of Claim 8 in which said step is optionally made substantially horizontal or sloping inwardly and downwardly at an angle between 5° and 30°.

10. The tray of Claim 8 in which, where said step is employed as a rest for the handles of forceps, scissors or the like, suitable lugs being optionally provided on it to retain said handles in place.

11. The tray of Claim 8 in which, in order to provide greater stability of said tray on a supporting surface, the lower edge of said end wall upper part is extended downwardly to create a skirt which bears upon the supporting surface.

12. The tray of Claim 1 in which, in order to provide a haptic warning to a user and, thereby, to minimise the possibility of intrusion of a finger or thumb of the user into the interior of said tray, the inner edge of said horizontal flange is raised around the full circumference of said flange.

13. The tray of Claims 1 and 12 in which, in order to permit said finger well to be located by touch, the edges of said finger well are raised, the height of said raised edge of said finger well being made from 2 to 4 times greater than the height of said raised edge of said circumferential flange.

14. The tray of Claim 1 in which the stability of said tray while resting upon a supporting surface is enhanced by the provision of stabilisers fixed to the outer ends of said instrument channel.

15. The tray of Claim 14 in which said stabilisers take the form of D-shaped skirts attached by inwardly directed lugs formed on their more or less straight, inner ends slidingly engaging complementary channels formed in the side surfaces of said instrument channel support flanges, semi-circular parts of said stabilisers being orientated outwardly.

16. The tray of Claim 14 in which said stabilisers take the form of transverse bars attached by inwardly directed pairs of curved arms enclosing the ends of said instrument channel support flanges, lugs or detents formed on the ends of said arms engaging complementary detents or lugs formed on the side surfaces of said support flanges.

17. The tray of Claim 14 in which said stabilisers are permanently attached to said tray in a post-manufacturing process or are made in clip-on, detachable form, the delayed attachment of said stabilisers permitting said trays to be closely stacked and thereby facilitating packing and transportation.

18. The tray of Claim 1 in which, to facilitate close stacking, all surfaces abutting during stacked arrangement are made with suitable draft angles.

19. The tray of Claim 1 in which the exterior surfaces of said finger well immediately adjacent said raked side walls and the side exterior surfaces of said end wall upper parts are suitably ribbed or textured to allow the fingers of a user to more positively grasp them.

20. The tray of Claim 1 in which the lateral exterior surfaces of said finger well are made flat or slightly convex and are adapted for the printing or moulding of text and/or decoration.

21. The tray of Claim 1 in which a handle stem has at its distal end a transversely arranged bar to which are fixed two or more curved engagement elements, said tray being engaged by tilting said handle stem sharply upwards in order to pass said engagement elements downwardly through suitable apertures provided in said horizontal flange, returning said handle stem to a more or less level attitude such that the free ends of said engagement elements abut the underside of said flange, and lifting said handle stem and tray together.

22. The tray of Claim 1 in which the floor of said instrument channel is made coplanar with the floor of said finger well and a plurality of raised ribs is provided passing transversely across said instrument channel, said ribs raising a surgical instrument resting in said channel above the floor of said finger well, thereby facilitating the grasping of said instrument.

23. The tray of Claim 8 in which said step is provided at one or both ends of said tray, each said raked side transitioning via raked, curved surfaces to a raked, curved end wall lower part.

24. The tray of Claim 1 in which attachment means are fixed to said instrument channel support flanges, said means taking the form of one or more attachment tabs optionally provided with keyhole apertures to engage complementary lugs, adhesive pads, areas of magnetic material, areas of one or other part of the Velcro® attachment system, or the like.

25. The tray of Claim 24 in which said tabs are fixed to a transverse bar on which are formed two or more split lugs, said tabs being fixed to said instrument channel support flanges by passing said split lugs through complementary apertures therein, the heads of said split lugs expanding to engage said flanges.

26. The tray of Claim 1 made from any suitable, rigid polymer material adaptable to sterilisation by the gas or radiation methods, including ethylene oxide and gamma radiation.

27. The tray of Claim 1 made as a disposable item from a biopolymer material unsuitable for gas sterilisation in which, where said tray is to be included in a surgical pack to be sterilised by gas sterilisation, said tray is first sealed in a suitable polymer film enclosure and sterilised by gamma radiation.

28. The tray of Claim 1 comprising any feasible combination of any one disclosed feature with any other disclosed feature or features.