FIELD OF THE INVENTION

The invention generally relates to a mesher for perforating a material. In particular the invention relates to a mesher device for use in medical and/or surgical applications.

BACKGROUND TO THE INVENTION

Skin graft meshers are designed to incise and "mesh" a piece of natural or artificial skin prior to grafting in order to allow it to expand and cover a larger area than its donor site area. For instance, the common expansion ratio for dermal meshers is 1 :1.5, meaning that a piece of skin can be meshed to cover one and a half times more surface area than the size of the donor site. The apertures created also provide improved drainage to exudate from the recipient site. Conventional meshing systems, an example of which is shown in Figure 1 include a mesher containing a cutting drum (roller) and skin graft carriers. Problems associated with this design, particularly in a medical environment, include, but not limited to:

Time consuming to assemble

Risk of losing the skin graft between the rollers

Risk of contamination between patients

Blades rapidly become blunt

Bulky

Unwieldy

Require a substantial amount of force to mesh the skin graft often needs more than one person

Surgeons are also known to make slits in the skin graft simply by using a scalpel. This is an inaccurate and laborious process.

There is therefore a need for a mesher which overcomes some or all of the above problems associated with the prior art methods. In particular there is a need for a mesher in which a fresh set of blades can be used during the preparation of a skin graft or multiple skin grafts for an individual patient, thereby abolishing the risk of cross-patient contamination and also ensuring that the blades are of optimal sharpness thus minimising damage to the tissue during the perforation process.

SUMMARY OF THE INVENTION

According to a first aspect of the invention there is provided a device for puncturing a material, the device comprising; a) a support member for supporting the material,

b) a puncturing element carrier and;

c) a plurality of puncturing elements, wherein at least the puncturing elements are disposable.

According to a second aspect of the invention there is provided a disposable puncturing element carrier having a plurality of puncturing elements associated thereon for use in the device according to the first aspect of the invention.

According to a third aspect of the invention there is provided a kit comprising a puncturing element carrier having a plurality of puncturing elements associated thereon and a material support member.

According to a fourth aspect of the invention there is provided a material manufactured using the device according to the first aspect of the invention. According to a fifth aspect of the invention there is provided a skin graft substitute prepared using the device according to the first aspect of the invention.

According to a sixth aspect of the invention there is provided a tissue or tissue substitute mesher device for use in perforating the tissue or tissue substitute, the device comprising;

a) a support member for supporting the tissue or tissue substitute,

b) a puncturing element carrier and;

c) a plurality of puncturing elements, wherein at least the puncturing elements are disposable.

According to a seventh aspect of the invention there is provided a disposable tissue or tissue substitute mesher device for use in perforating the tissue or tissue substitute, the device comprising;

a) a support member for supporting the tissue or tissue substitute,

b) a puncturing element carrier and;

c) a plurality of puncturing elements.

According to a eighth aspect of the invention there is provided a device, a material, a disposable puncturing element carrier, or a kit as substantially herein described with reference to the accompanying Examples and Figures.

In embodiments of the invention the types of and the arrangement of the puncturing elements on the carrier can differ depending on the particular application. Suitable puncturing elements would be known to a man skilled in the art, and can include, for example, spikes, needles and blades.

The puncturing elements can be made of a metal or a plastic having a suitable rigidity.

The puncturing element carrier can be made of a metal or a plastic.

The puncturing elements can be manufactured as an integral part of the puncturing element carrier. In this embodiment at least the puncturing elements and the puncturing element carrier are disposable.

Alternatively the puncturing elements can be associated with the puncturing element carrier post-manufacture. The puncturing elements can be individually associated with the carrier, although this will be time consuming and would require substantial dexterity. Alternatively the puncturing elements are provided on a carrier material which itself can be associated with the puncturing element carrier. For example this carrier material can be adhered to the carrier, such that after use, the carrier material (with associated puncturing elements) can be removed from the carrier and disposed of.

The support member is preferably provided with a plurality of perforations which are complementary to the pattern of the puncturing elements, such that the puncturing elements can pass completely through the support member. This minimises the blunting of the blades and additionally ensures that the perforations completely traverse the material.

Although it is envisaged that the puncturing element carrier can be provided with means that will enable it to be hand-held such that the user can puncture the material using a simple stamping action, in some situations it may be desirable to ensure an even application of pressure to the material and/or an increased pressure may be required for resilient materials. Therefore, in further embodiments of the invention the support member and the puncturing element carrier are located in a stand such that the reciprocal movement of i) the puncturing element earner towards the support member and/or ii) the material support member towards the puncturing element carrier is guided by the walls of the stand. For example the walls of the stand are provided with grooves within which the puncturing element carrier and/or the material support member are received and moveable. This ensures that the puncturing elements contact the material in an even manner.

In embodiments of the invention the material support member is static and the puncturing element carrier is moveable theretowards.

In alternative embodiments of the invention the puncturing element carrier is static and the material support member is moveable theretowards.

In a further embodiment of the invention at least i) the puncturing element carrier towards the support member and/or ii) the material support member is provided with a handle, such as a plunger.

It is envisaged that the mesher can be used to perforate a wide variety of materials in a range of applications.

The materials can be natural, synthetic or composites thereof.

It is envisaged that the mesher can be used in surgical and medical applications. For example, in the puncturing of a human or non-human animal tissue such as a skin graft or a skin substitute material. The skin graft or skin substitute material can be derived from natural and/or synthetic materials. Such skin substitute materials include, for example, dermal replacement products and epidermal replacement products. A specific example of a product is a split thickness skin graft.

It is further envisaged that the mesher can be used for the perforation of dressings, such as wound dressings. For example OPSITE™ (Smith & Nephew, Inc)

Other non-surgical/medical applications of the mesher can be envisaged in which the perforation of a material is required. For example in the clothing/textile industry. When used for surgical and medical applications, the components of the device are sterile.

In embodiments of the invention the following components of the device are disposable;

- the puncturing elements alone or in combination with;

- the puncturing element earner, and/or

- the material support member, and/or

- the stand, and/or

- the handle

When used for surgical and medical applications it is advantageous that the entire device is disposed of following use on a particular patient, thereby preventing any chance of cross-contamination between patients. When used for non-surgical and medical applications, it may only be desirable that the puncturing elements are disposable, thereby ensuring the optimum sharpness of the puncturing elements. As cross- contamination of patients tissue is not a consideration in such applications the other components of the device do not necessarily need to be disposable.

SPECIFIC EMBODIMENTS OF THE INVENTION

The invention will now be described with reference to the accompanying Figures in which,

Figure 1 : A photograph of a conventional skin graft mesher Figure 2: A photograph of a skin graft having a mesh-like appearance

Figure 3: A schematic of an embodiment of the device according to the invention

Referring to Figure 3, the device comprises a stand 1 having a base 1a from which two arms members 1 b upwardly project when in use. The static material support member 2 bridges the two arm members and is substantially parallel with the base. The puncturing element carrier 3 is provided with a plurality of puncturing elements 4. The carrier is located above the material support member 2 and and is moveable relative thereto. A plunger 5 is provided on the upper surface of the carrier.

The device is sterile.

The device is disposable. Directions for use:

1. Place material on the upper surface of the material support member,

2. Insert the puncturing element carrier between the vertical arms of the stand, such that the puncturing elements are pointing towards the material,

3. Using the plunger apply pressure to push the puncturing element carrier downwards towards the material,

4. Puncture the material,

5. Using the plunger pull the puncturing element carrier upwards away from the material,

6. Remove the puncturing element carrier from the stand,

7. Remove the material from the material support member,

8. Dispose of the device.

Although the use of this device has been described in one particular orientation, one can imagine that the device can be turned 90° so that one of the arm members becomes the base and the plunger movement is horizontal rather than vertical.