A Disposable Light Handle Cover and Applicator

Field of the Invention

The invention relates to surgical light handle cover assembly. In particular, the invention relates to a disposable surgical light handle cover and applicator.

Background to the Invention

Surgical lights provide illumination of the operating site. There are many different manufacturers of surgical lights, each with their individual styles of light head design and interface points, i.e. handles, displays and controls. Manipulation of the surgical light is facilitated by a handle that can be gripped and used to pull/push the light head in the desired direction. Given the aseptic requirements of surgery, the handle that is used by sterile operatives must also be sterile. There are two approaches to ensure the sterile field of the handle within an operating theatre is not compromised:

1) The surgical light manufacturers allow for the handles to be disengaged from the light head and sterilised via autoclave. Although constructed from durable plastics, for example, Nylon (PA66), with a thick cross section, these handles have a finite number of sterilisation cycles that they can endure and resultantly are periodically replaced. The sterilisation process can be costly and may increase the risk of damage to or loss of the light handle. Furthermore, these handles are expensive and the hospital must own a large number of them to efficiently change over between procedures. 2) A number of medical device manufacturers construct sterile barriers that cover the light handle entirely and prevent the sterile operatives hand from coming into contact with non-sterile surfaces. This negates the need for the hospital to re-sterilise the handles as the sterile users hand never comes into contact with non-sterile surfaces .

The above approaches can be divided into two further categories: (i) replacement handle systems that incorporate a disposable cover and (ii) standalone disposable covers.

For (i) replacement handle systems, the manufacturer provides a replacement handle that is permanently attached to the light head/handle and features a secure mounting point for the cover to mate with.

For (ii) standalone light handle covers, the user does not replace the light handle or attach an adapter and as such the handle has no secure mounting point. An example of a standalone cover is the Microtek Light Handle Cover (Microtek Medical), which relies purely on elastic mechanical forces acting against the handle. These forces overcome the weight of the product itself but when a user interacts with it, it moves position on the handle. Having no secure mounting point permits the cover to slide down the handle during use and could eventually slide off entirely without intervention from the user. A replacement surgical light handle and cover are described in United States Patent Number 5,599,093 (hereinafter the ^y 093 patent) . The replacement light handle of the ^y 093 patent is meant to replace existing light handles and is assembled using glue or fasteners to ensure the parts of the replacement handle remain tight together. A cover is then slipped over the replacement light handle and secured thereto. A light handle adapter is also described in the ^y 093 patent for use with an existing handle and cooperates with the light handle cover described therein. Another proposed solution can be found in US Patent No. 4,605,124 (Sandel Dan et al.; hereinafter the ^y 124 patent) . The ^y 124 patent describes a disposable light handle cover having a generally cylindrical grip with connectors matingly engaging with the light handle. The interior portion of the cover has adhesive materials pre-applied so that the cover and handle are secured together when in contact. An alternative arrangement is where a plurality of spaced ribs are provided integrally of the grip portion of the cover to facilitate the fit of the cover to the handle.

However, adhesive or fasteners are required to affix and secure the adapter to an existing light handle. The problem with an adhesive or glue is that both the replacement light handle and adapter cannot be sterilised by normal sterilisation techniques such as autoclaving. The high temperatures required for sterilisation would reduce the integrity of the adhesive or glue.

The use of an adhesive as an option is not suitable because of the following reasons:

1) glue deposits can be left on a light handle which have to be removed and thus causing unnecessary work;

2) gluing or screwing into the light handle presents a large possibility of damaging the handle or the lighting fixture. This sentiment is echoed by current users of the replacement handle/adaptor solution in that they fear damage to their light from using this solution; and

3) distance between inner wall of adaptor and outer wall of handle will vary significantly. There is no feasible way in which an adaptor can be glued to any handle without custom manufacturing the adaptor to exactly match the geometry of the handle where they intend to glue.

The sterile barrier approach, especially the replacement handle/ adaptor approach, suffers from the fact that there are so many surgical light manufacturers, each with their own individual designs. This translates into a range of sizes and shapes that is very difficult to satisfy with a standard solution. Consequently for manufacturers of the replacement handle system, at least 36 unique variations of handle are needed that have individually customised geometry to match handles/light fixtures.

There is therefore a need to provide a universal light handle cover system. It is an object of the present invention to overcome at least some of the above-mentioned problems .

Summary of the Invention

According to the present invention there is provided, as set out in the appended claims, a light handle cover applicator for use with an existing light handle attached to a surgical light fixture, the applicator comprising: a body member having a first end and a second end, an outer diameter and an inner diameter;

a gripping member continuous with the outer portion of the body; characterised in that the gripping member comprises an engagement means for securing the applicator with the light handle; and

a support means for matingly engaging with a light handle cover.

In one embodiment of the present invention, there is provided a light handle cover applicator for use with an existing light handle attached to a surgical light fixture, the applicator comprising:

a body member having a first end and a second end, an outer diameter and an inner diameter;

a gripping member continuous with the outer portion of the body; characterised in that the gripping member comprises

an engagement means for securing the applicator with the light handle;

a support means for matingly engaging with a light handle cover; and

a spacer for co-operating with the inner diameter of the body member .

In one embodiment of the present invention, the inner diameter of the body member is larger than the widest diameter of the light handle to provide slidable movement of the body member along the length of the light handle.

In one embodiment of the present invention, the engagement means may comprise a threaded bore, a threaded member, a threaded locking insert and a clamping member connected to and actuated by the threaded insert. Preferably, the threaded bore is reinforced by the threaded insert, which may be, for example, a helical screw-locking spring. In one embodiment of the present invention, the applicator may further comprise a spacer.

In one embodiment of the present invention, the spacer may face opposite the clamping member along a horizontal axis of the applicator and sits proud of the inner diameter of the body member .

In one embodiment of the present invention, the spacer may co-operate with the inner diameter of the body member.

In one embodiment of the present invention, the support means may comprises a flange portion extending from an annular ring which forms the second end of the body member.

In one embodiment of the present invention, the applicator may be configured for multiple sterilisation cycles.

In one embodiment of the present invention, there is provided a disposable light handle cover for use with the light handle applicator as described above, the cover comprising :

a flexible cylindrical hollow body having an open end and a closed end;

a circular flange integral with and extending

outwardly adjacent the open end of the hollow body; and

a plurality of snaps provided along a circumference of the open end;

characterised in that the circular flange, having a series of spines radiating out from the open end of the hollow body to an outer edge of the flange, is rigid.

In one embodiment of the present invention, the plurality of snaps may be adapted to matingly engage with the flange portion of the annular ring extending from and forming part of the second end of the body member of the light handle applicator .

In the specification, the term "applicator" should be understood to mean an adapter and/or a means for allowing a light handle cover to attach and cover a light handle.

In the specification, the term "snap(s) " should be understood to mean, as per the industry standard ("The First Snap-Fit Handbook", 1 ^st Edition, (P. Bonenberger) (2000)) a mechanical joint system where part-to-part attachment is accomplished with locating and locking features (constraint features) that are homogenous with one or the other of the components being joined. Joining requires the (flexible) locking features to move aside for engagement with the mating part, followed by return of the locking feature toward its original position to accomplish the interference required to latch the components together. Locator features, the second type of constraint feature, are inflexible, providing strength and stability in the attachment. Enhancements complete the snap-fit system, adding robustness and user-friendliness to the attachment. The commonest form of snaps are annular (circular connectors), cantilever (hook and recess), and torsional (a latch is attached to a torsion bar or shaft) . Snap fits are commonly used as an assembly method for injection molded parts. The snaps are molded into the product, so additional parts are not needed to join them together. Additionally, if designed correctly, they can be disassembled and reassembled several times without any problems. A snap fit can either be designed as a permanent snap or a multiple snap. Permanent fits are used in disposable parts that are never meant to be disassembled. Multiple snaps are used in most designs where disassembly for service is expected.

In one embodiment of the present invention, the circular flange may further comprise a series of concentric reinforcement circular members radiating out and away from the open end.

In one embodiment of the present invention, the light handle cover may be a single-use cover pre-sterilised before connecting to the applicator.

The cover may be thermoformed as a single part, consisting of two main elements: 1) a rigid circular flange, known as the Hand Guard, and 2) a cylindrical hollow body, which covers the shaft of the light handle.

The surface geometry of the circular flange (concentric reinforcement circles and spines), combined with the starting thickness of the plastic sheet (before Thermoforming the plastic sheet has a starting thickness of between about 0.05mm to about 2.0 mm, preferably about 0.1 mm to about 1.0 mm, more preferably between bout 0.25 mm and 0.75 mm, and ideally about 0.5mm), gives this section of the light cover increased strength. This increased strength means the circular flange is rigid and can protect the users hand from travelling upwards and touching non- sterile surfaces. The increased strength also aids in attaching the cover to the applicator, i.e. a rigid body is much easier to push onto the annular ring of the applicator than a weak flexible one. In one embodiment, the material of construction is suitably a durable yet rigid material, for example polypropylene, polyethylene ( PE ) , polyethylene terephthalate copolymer ( PE TG ) , amorphous polyethylene terephthalate ( APE T ) combined with the thin wall thickness of between about 0.05mm to about 2.0 mm, preferably about 0.1 mm to about 1.0 mm, more preferably between bout 0.25 mm and 0.75 mm, and ideally about 0.5mm along the shaft of the cover allows it to be flexible so it can deform to the contours of the light handle and also be collapsed for packaging.

In one embodiment of the present invention, the disposable light handle cover may further comprise a rigid cylindrical portion extending around and below the plurality of snaps suitable for engaging with a light handle.

In one embodiment of the present invention, there is provided a light handle cover assembly for use with an existing light fixture having a handle in a surgical room, the assembly comprising a light handle cover applicator and a disposable light handle cover as described above.

One of the advantages of the assembly of the present invention is that the applicator is adaptable due to the clamping means and spacer to provide an assembly which is a "one size fits all" applicator. The rigidity of the cover of the present invention further provides the advantage ease of assembly and protecting a user's hand from travelling upward past the cover and contacting non-sterile surfaces of a light fixture.

Brief Description of the Drawings

The invention will be more clearly understood from the following description of an embodiment thereof, given by way of example only, with reference to the accompanying drawings, in which:-

Figure 1 illustrates a cross-section plan view of the light handle cover applicator of the present invention attached to an example of a light handle;

Figure 2 illustrates perspective view of the light handle cover applicator of the present invention;

Figure 3 illustrates an isolated view of the clamp and spacer which form the clamping members of the light handle cover applicator of the present invention;

Figure 4A illustrates an example of a light handle of a surgical light;

Figure 4B illustrates the light handle cover applicator of the present invention being positioned prior to engaging with the light handle of Figure 4(A), and Figure 4C illustrates the light handle cover applicator of the present invention engaged securely with the light handle of the surgical light;

Figure 5 illustrates a perspective view of a light handle cover of the present invention;

Figure 6A illustrates a the light handle cover of Figure 5 being fitted to a light handle with the applicator of Figure 1 in place, and Figure 6B illustrates the light handle cover of Figure 5 connected to and engaged with the light handle applicator of Figures 1 to 3; and

Figure 7 illustrates a side view of the light handle cover of Figure 5 connected to and engaged with the light handle cover applicator of Figures 1 to 3, with the light handle cover in cross-section.

Detailed Description of the Drawings

The present invention provides a standardised light handle cover applicator and a disposable light handle cover for use with an existing light handle attached to a surgical light fixture commonly found in operating theatres and the like. The applicator may be used with any pre-existing surgical light fixture, which dispenses with the need for replacement handle systems thereby providing a hassle-free and cost-saving system. Furthermore, the applicator is easily removed from the light handle and can be subjected to numerous cleaning and/or sterilisation cycles in, for example, an autoclave. Furthermore the applicator is easily removed from the light handle by an unskilled user, allowing both the applicator and light handle to be individually cleaned.

The disposable light handle cover of the present invention is flexible which permits the cover to deform to the contours of the light handle and also be collapsed for packaging. The disposable light handle cover is secured over the light handle by male-female connection with the applicator. The secure connection to the applicator provides a secure semi-permanent connection that allows for easy assembly and disassembly.

Referring now to the figures, where Figure 1 illustrates a general embodiment of a light handle cover applicator of the present invention. Specifically, Figure 1 illustrates a plan view of a applicator of the present invention attached to an example of a light handle, and is generally referred to by reference numeral 1. The applicator 1 of the illustrated embodiment comprises a body member 2 having a first end 3 and a second end 4 (shown in Figure 2) . The body member 2 further comprises an outer diameter 5 and inner diameter 6. The inner diameter 6 of the body member 2 defines a central bore 7 within which a light handle 17 is accommodated.

The light handle cover applicator 1 further comprises a gripping member 8 which is continuous with the outer diameter 5 of the body member 2. Housed within the gripping member 8 is an engagement means 10, which is suitable for engaging the applicator 1 with a light handle. The engagement means 10 comprises a threaded bore 11 a threaded member 12, a threaded locking insert (such as a helical spring) and a clamping member 14. The clamping member is connected to and actuated by the threaded locking insert . The inner diameter 6 of the body member 2 further comprises a spacer 15, which faces opposite to the clamping member 14 along a horizontal axis A. The spacer 15 and clamping member 14 are flush with a surface 16 of the annular ring portion 7 to form an enclosed ring. The body member 2 has a central core 17 enclosed by the annular ring portion 7.

As illustrated in Figure 2, there is presented a perspective view of the applicator 1 of Figure 1 in a disengaged position. The second end 20 is visible below the body member 2. The second end 20 forms part of a support means 21 which comprises a flange portion 22 extending from an annular ring 23 which forms the second end 20 of the body member 2. Figure 3 illustrates an extracted perspective view of the engagement means 10 and spacer 15 of the applicator 1. The engagement means 10 further comprises a support pad 30 connected to the rear of the clamping member 14. The support pad 30 acts to exert pressure on the clamping means 14 when the threaded member 12 reinforced by the threaded locking insert is engaged by a user. Turning the threaded locking insert within the threaded member 12 with, for example, an alien key or other suitable tool for turning a threaded locking insert, forces the threaded locking insert in the direction of the clamping member 14 along the axis A. On either side of the helical bore 11 are pins 31, 32 which act to maintain the position of the support pad 30. The pins 31, 32 are also housed within the gripping member 8 in channels 33, 34 (see Figure 1), respectively, and are free to move along channels 33, 34 in the direction of the movement of the clamping means 14. In use, as illustrated in Figure 4A-4C, the applicator 1 acts as a clamp. A light handle 41, commonly found in surgical rooms, is attached to a light fixture 40 (Figure 4A) . There are many variations in size and shape of light handles, ranging from circular to triangular cross section. The applicator 1 is shaped to fit over a large range of light handles. The applicator 1 is slid onto the handle 41 from the bottom 42 to the top 43 of the handle 41 where it meets the light fixture 40 (Figure 4B) . When suitably placed at the top 43 of the handle 41, the user tightens the threaded locking insert within the threaded member 12, which moves the clamping member 14 forward to engage the light handle 41, while the spacer 15 provides cushioning and engagement from the opposite side along axis A. The rigidity of the body member 2 allows the spacer 15 to act in opposition of the clamping member 14, ensuring a tight grip and secure attachment point for a light handle cover. The clamping member 14 and spacer 15 are generally constructed of tough rubber-like thermoplastic vulcanizate families of thermoplastic elasotmers, for example, Sarlink® 3139D (Teknor Apex Company, U.S. A) which is a high hardness, multi-purpose thermoplastic elastomer featuring excellent resiliency, heat resistance and flex fatigue resistance.

In Figure 5, there is illustrated a perspective view of a disposable light handle cover 50. The cover 50 comprises a flexible cylindrical hollow body 51 having an open end 52 and a closed end 53. Extending outwardly adjacent and integral with the open end 52 is a circular flange 54 having a series of spines 55 and concentric reinforcement circular members 56. The circular members 56 radiate out and away from the open end 52. The spines 55 and circular members 56 confer rigidity to the flange 54 which permits the user to more readily attach the cover 50 to the applicator 1. The cover 50 further comprises a plurality of snaps 57 provided along a circumference 58 of the open end 52. The flange 54 further comprises an outer lip 60 which is flexible.

In use, as illustrated in Figure 6A and 6B, the cover 50 is removed from a sterile packaging and pushed up the light handle 41 until the snaps 57 engage with the flange portion 22 extending from the annular ring 23 of the second end 20 of the applicator 1. As the cover 50 engages with the applicator 1, the snaps 57 snap-fit the cover 50 securely to the applicator 1. The cover 50 and applicator 1 are now connected securely together in a semi-permanent join that allows for easy assembly and disassembly. The applicator 1 and cover 50 stay securely in position for the duration of the procedure, until the user decides to remove the cover 50. There is very little risk of the cover 50 disengaging from the applicator 1 without user consent.

Figure 7 illustrates the cover 50 securely attached to the applicator 1. The cover 50 is presented in cross-section. The interaction between the snap 57 and the flange portion 22 is shown in more detail in the highlighted inset B of Figure 7. The snap 57 illustrated in Figure 7 is generally termed a "cantilever snap-fit" and comprises a raised lip portion 57b and a receiving port 57a. The receiving port 57a receives the flange 22 , while the raised lip portion 57b is accommodated in a space 29 formed between the body member 2 , the annular ring 23 and flange 22 . The cover 50 further comprises a rigid cylindrical portion 59 (see also Figure 5) extending around and below the plurality of snaps 57. The cylindrical portion 59 acts as a rigid gripping/pushing point for the user when pushing the cover 50 up a light handle to engage with the applicator 1.

The applicator 1 and disposable cover 50 of the subject invention are advantageous over the light handle adaptors and covers of the prior art. For example, (1) The applicator 1 is a standardised product, which does not need to be custom-manufactured for each individual style of light handle, that is, handles that vary greatly in size and shape; 2 ) the light handle over assembly of the present invention can be installed by an unskilled user, and removed easily for cleaning; 3 ) the light handle assembly of the present invention does not interfere with the light fixture or light handle in anyway, which is a fear expressed by users of those solutions described in prior art; and 4) many of the current solutions must be screwed into the light fixture or handle in order to function. The applicator 1 of the present invention can be attached/detached without risk of damaging or interfering with light handle/light fixture.

In the specification the terms "comprise, comprises, comprised and comprising" or any variation thereof and the terms "include, includes, included and including" or any variation thereof are considered to be totally interchangeable and they should all be afforded the widest possible interpretation and vice versa.

The invention is not limited to the embodiments hereinbefore described but may be varied in both construction and detail.