Field of the Invention The present invention relates to a dispenser such as a sterile medical adhesive applicator device specifically for the purposes of wound closures. More particularly, the present invention relates to surgical multipurpose device for cleaning and further operating surgical wound closure procedures.

Background of the Invention All surgical wound closure procedures involve multiple steps involving cleaning and drying the wound site, closing the wound by approximating the wound edges and then using an appropriate instrument of closure like sutures, staples or sterile adhesives like cyanoacrylate. Once the wound is closed a holding tape is also applied over the top of the closed wound to hold the edges together and to give the closure an extra strength so that the edges wound not come apart.

Modern-day medicine presently has a multiplicity of different treatment possibilities available for wound treatment, in particular for wound closure. Routinely, for example, suture materials and what are called surgical tacking devices are employed. These can be used to successively treat large and, in particular, deep wounds. However, this form of wound treatment causes a certain degree of traumatization of the wound environment. A further disadvantage is the formation of scar tissue, which especially in the case of wounds treated superficially can lead to cosmetically unsatisfactory results.

As an alternative to the above-described wound closure materials, therefore, liquid adhesive compositions as well are increasingly being used in wound management. Such adhesive compositions are based in particular on cyanoacrylate monomers.Monomer and polymer adhesives are used in both industrial (including household) and medical applications. Included among these adhesives are the ethylene monomers and polymers, such as the [alphaj-cyanoacrylates. Since the discovery of the adhesive properties of such monomers and polymers, they have found wide use due to the speed with which they cure, the strength of the resulting bond formed, and their relative ease of use. These characteristics have made the [alphaj-cyanoacrylate adhesives the primary choice for numerous applications such as bonding plastics, rubbers, glass, metals, wood, and, more recently, biological tissues.

The cyanoacrylate monomer comprises monomers which cure rapidly in the presence of bodily fluids. Adhesive compositions based thereon must therefore be stored and kept in a form which prevents premature curing of the adhesive composition. At the same time, the adhesive compositions must be applied in a sterile state to the wound, to rule out possible wound infections. Corresponding applicator systems for administering the adhesive compositions must meet these requirements. Moreover, it ought to be possible to produce applicator systems of this kind at a cost which as far as possible is acceptable economically. Before being applied, adhesive compositions are frequently kept or stored in glass ampules. Within the glass ampules, the adhesive compositions are indeed protected from moisture and atmospheric oxygen. However, glass ampules have proven largely to be awkward in terms of their handling in the practice of medical treatment. The ampules must first be broken to release the adhesive compositions. On the one hand, this makes controlled application of the compositions more difficult, and on the other hand it poses a certain risk of injury to the surgeon from the broken glass.

In prior art, an European Patent EP 0 832 137 Bl discloses an applicator for an adhesive composition, comprising an inner glass ampule, which contains an adhesive composition and an outer plastic ampule. Exerting an external pressure on the plastic ampule causes the inner glass ampule to fracture, and, consequently, the adhesive composition emerges from the glass ampule and can be applied to a wound via a discharge opening. To prevent glass splinters entering the wound, the discharge opening has a fine porosity. A disadvantage there, however, is that, owing to the porosity and size of the discharge opening, the adhesive composition may also emerge at the periphery of the discharge opening. In this way, controlled release of the adhesive composition from the applicator is made more difficult.

Further in prior art an effective applicator system is disclosed in U.S. Pat. No. 5,928,611. This patent discloses an applicator system generally comprising a tube containing a frangible vial of monomeric adhesive composition. One end of the tube is sealed, and the other end is closed by an applicator tip comprising a solid support having a polymerization or cross- linking accelerator or initiator for the monomeric adhesive disposed thereon or therein. As shown in FIG. 3 of the patent, the applicator tip can be generally dome shaped. The applicator device of U.S. Pat. No. 5,928,611 shows an applicator device comprises a cylindrical applicator container holding polymerizable and/or cross-linkable material enclosed in a frangible vial and an applicator tip containing a polymerization and/or cross- linking initiator. One development of an applicator system of that kind is known from WO 01/51218 Al, whereby the discharge opening may be provided with furrows or channels, which in particular are porous. They are intended to allow focused application of the adhesive compositions. Depending on the configuration of the discharge opening, applicator systems of this kind can be produced only with a relatively high level of technical complexity. Problems with known applicators and/or dispensers include, for example, the adhesive or sealant material being fed from the applicator device by gravity only. Such gravity feed methods may not allow for desired control over the flow of the adhesive or sealant material from the applicator device during use. Furthermore, known applicators/dispensers may not allow for fine control over and placement of the adhesive or sealant material at the time of use.

To perform a successful wound closure procedures the availability of many different objects are needed and are required to be present at the right time. As an example, non-availability of a sterilizing swab which can sterilize the site of wound would likely make the closed wound prone to post-surgical infection which can have dire consequence to the patient and additional expenses thereof.

Similarly, a wound site that is not thoroughly dried of blood and other fluids before the closure procedure can lead to reopening of the closed edges. This situation can help bacteria and other micro-organisms to enter the wound site thus leading to infections.

In case of use of medical adhesives like cyanoacrylates as discussed above, the surgeon sometimes applies multiple layers of adhesive on the same wound to give it extra closure strength. In case of multiple applications of adhesive on the wound site, generally an application of adhesive in the form of fine micro drops as a first coat and then application of another coat of adhesive as thin ribbon over the first one. These multiple applications require different type of physical delivery systems so that the adhesive can be delivered either in the form of fine micro drops or in the form of a thin ribbon of adhesive film. It could, therefore, be helpful to provide an economically advantageous multipurpose wound closure device for adhesive compositions which on the one hand meets the ever-growing requirements in terms of the sterility and the storage stability of adhesive compositions, and on the other hand allows extremely simple and low-risk handling in everyday medical treatment practice.

SUMMARY OF THE INVENTION

The present invention addresses the above and other needs by providing sterile medical device for surgical wound closure procedures alongwith a dispenser that allow increased precision in control of placement of the adhesive composition, and a decrease in waste of adhesive. In addition needs are addressed by providing applicators and dispensers that permit economical and efficient use of adhesive or sealant compositions. In embodiments applicators and or dispensers are provided that are user friendly.

The present invention provides for a multipurpose medical device made up of metallic or preferably polymer materials comprising of that are amenable to sterilization. Therefore such as herein disclosed is a multipurpose sterile medical device for surgical wound closure, the device comprising:a body portion consists of a soft and flexible polymer jacket on one side (top) and hard polymer tube on the other side (bottom) providing a cavity, the cavity sized to accept a frangible container having a medical adhesive material; a micro tip that has narrow channel opening disposed on the top end of the flexible polymer jacket and is embedded with micro porosity polymer filter;a 'pressing tong' disposed in a central position of the body configured as a breaking member to the frangible container by partially deflectable into the cavity; at least one holding tape roll consisting of medical tape disposed below the pressing tongs over the hard polymer tube; anda soft absorbent stick disposed at the bottom side of the hard polymer tube and further on the outer side of the said body. Also disclosed is a method of operating a multipurpose sterile medical device for surgical wound closure, the method comprising:providing a multipurpose sterile medical device for surgical wound closure, the said device comprising:a body portion consists of a soft and flexible polymer jacket on one side (top) and hard polymer tube on the other side (bottom) providing a cavity, the cavity sized to accept a frangible container having a medical adhesive material;a micro tip that has narrow channel opening disposed on the top end of the flexible polymer jacket and is embedded with micro porosity polymer filter;a pressing tong disposed in a central position of the body portion configured as a breaking member to the frangible container by partially deflectable into the cavity; at least one holding tape roll consisting of medical tape disposed below the pressing tongs; anda soft absorbent stick disposed at the bottom side of the hard polymer tube and further on the outer side of the said body;cleaning and drying the wound site using absorbent stick component by gently rubbing on the application site so that any blood or any other fluids get absorbed thus rendering the wound site clean and dry;removing the flat delivery tip from the top portion of the flexible polymer jacket and moving the device over the wound;holding the device over the "pressing tong" portion between the thumb and the forefinger and pressing firmly so that the glass ampoule in turn is crushed to release the adhesive into the jacket;squeezing the body over the pressing tong by providing a positive pressure and dispensing the stored adhesive material from the jacket to a substrate wherein the adhesive is passed through a micro filter and out through the fine channel on to the edges of the wound in the form of continuous micro drops and after dispensing the adhesive on the wound edges along the length of the wound, the pressure on the pressing tongs is released;releasing the squeezed body and thereby creating a negative pressure within the body for urging of the adhesive material from the cavity into the jacket; and disposing the device in a suitable manner once the closure application is performed to completion. The principle objective of current invention is to provide the doctor a sterile medical device that can provide a safe and unique totally self-contained system to perform a successful wound closure that involves medical adhesive.

One objective of the current invention is to enable the surgeon to be able to dry the wound site before the start of the surgical procedure. Yet another objective of the current invention is to provide a way to sterilize the wound site before starting the medical procedure.

Another objective of the current invention is to provide for a safe method to crush the glass ampoule so that the doctor or the user does not hurt himself or herself from cuts or wounds resulting from the sharp glass pieces that may accidentally pass the soft polymer jacket barrier that is generally employed in crushable ampoule systems. Another objective of the current invention is to provide a very sure and precise way for the doctor to express the adhesive out of the medical device on to the site of application so that very small quantities can be applied and thus increasing the patient comfort as well realizing a better outcome of the wound closure procedure. Another objective of the current invention is to enable the surgeon to provide a choice of delivery systems at his or her disposal to be used while closing the wound.

Yet another objective of the present invention is to provide for a well-established wound holding system that provides extra strength closed wound.

These and other objects of the present invention will become apparent to those skilled in the art as the description thereof proceeds.

BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS

Fig 1 illustrates the Multipurpose Single Use Sterile Medical Device in accordance with the present invention;

DETAILED DESCRIPTION In embodiments, a multipurpose sterile surgical adhesive applicator and/or dispenser is designed to facilitate manipulation by hand for dispensing and/or applying an adhesive or sealant material including cleaning, sterilizing and thereby closing of the wound and/or substrate wherein substrate is living tissue, a flexible material or skin or mesh. For example, applicators and/or dispensers are provided that are pen-like, providing a familiar feel to the user. In embodiments, an applicator is designed to reduce or eliminate leakage of adhesive from the device, be more securably gripped by the user, be more comfortable to the user, and/or easier to operate. The applicator allows for a "hands forward" position on the applicator device providing greater control over placement of the adhesive or sealant material. Additionally, the placement and length of the actuator allows for ease of use of the applicator while maintaining the hands forward position thereby allowing for greater control over the flow and direction of the adhesive or sealant material.

The preferred embodiment consists of multiple components assembled to form the medical device.The Main Component i.e. "body" consists of a soft and flexible polymer jacket on one side (top) and hard polymer tube on the other side (bottom). All other components are assembled on this Main Component. The main component is made preferably of medical grade polymer for example, polypropylene or polyethylene or PET.

The top of the Flexible Polymer Jacket consists of a micro tip that has narrow channel opening and is embedded with micro porosity polymer filter. Over the micro tip embodiment, a Flat Delivery Tip component is friction fitted.

The Flexible Polymer Jacket contains a crushable ampoule, preferably made of very thin glass, inside which a volume of liquid form of medical adhesive is filled in and hermitically sealed condition.

In the middle of the Main component, the Pressing Tongs component is present, which is made of a flexible but strong polymer, for example, polypropylene or polyethylene or PET, which when firmly pressed with the thumb and the fore finger presses on to the Flexible Polymer Jacket to crush the glass ampoule inside to release the adhesive.

Under the Pressing Tongs, Holding Tape Roll is assembled. The Holding Tape Roll consists of a sterile medical tape that is about five millimetres to twenty millimetre wide and about ten to fifty centimetres in length that is wound as a roll around the Main Component. The material of the wound tape can be a non-woven fabric or a polymer for example but not limited, poly urethane, polypropylene or polyethylene that has medical grade adhesive on one side so that it can stick to the skin or tissue to provide the required strength to hold the wound edges together. The Main Component bottom side consists of Hard Polymer Tube that carries on the outer side, a soft Absorbent Stick tube. This component is made up of highly absorbent polymer or non-woven fabrics made out of polymers for example, poly urethane, polypropylene or polyethylene or cotton or any other absorbent material like sponge.

Inside the Hard Polymer Tube, Sterilizing Liquid Stick is assembled with a stub on the bottom so that it can be pulled out during the usage of the device. The Sterilizing Liquid Stick is made of a polymer material polymers for example, poly urethane, polypropylene or polyethylene or cotton or any other absorbent material like sponge that is already wetted with a sterilizing or antiseptic agent liquid for example, isopropyl alcohol, ethyl alcohol, distilled water or combination thereof or iodine solution or povidone-iodine solution or a combination thereof. Usage Description of the Preferred Embodiment

The embodiment described above can be used in the following but not limited to the given usage description.

As a first step, the device is used to clean and dry the wound site using Absorbent Stick component by gently rubbing on the application site so that any blood or any other fluids get absorbed thus rendering the wound site dry.

The Flat Delivery Tip is removed and placed aside.

The device held in the hand and Pressing Tongs component is held between thumb and forefinger and pressed firmly. The Pressing Tongs component presses into the Flexible Polymer Jacket and on to the glass ampoule which in turn is crushed to release the adhesive into the Jacket.

The embodiment is inverted and brought to the wound site. The "Pressing Tongs" are pressed again with thumb and forefinger firmly to express the adhesive through the micro Filter and out through the fine channel and on to the edges of the wound in the form of continuous micro drops.

After dispensing the adhesive on the wound edges along the length of the wound, the firm pressure on the Pressing Tongs is released.

If required, the Flat Delivery Tip is now fitted on to the top of the Main Component and again the adhesive is expressed out using the Pressing Tongs to deliver a thin film ribbon of adhesive to be applied over the wound site.

In an embodiment the Sterilizing Liquid Stick is pulled out using the stub at the end and is rubbed gently on the wound site to sterilize the area. In addition the Absorbent Stick again can be used to absorb off any excess adhesive that sometimes runs off the wounds site on to the sides. The use of the sterilizing liquid stick and the absorbent stick component may be done repeatedly for wiping, cleaning, drying and other suited purposes.

Once the closure is completed using the adhesive, holding tape from the Tape Roll component is rolled out and cut into required small lengths to be applied on the closed wound to enhance the strength of the closure. The device is disposed in a suitable manner once the closure application is performed to completion.

Although the foregoing description of the present invention has been shown and described with reference to particular embodiments and applications thereof, it has been presented for purposes of illustration and description and is not intended to be exhaustive or to limit the invention to the particular embodiments and applications disclosed. It will be apparent to those having ordinary skill in the art that a number of changes, modifications, variations, or alterations to the invention as described herein may be made, none of which depart from the spirit or scope of the present invention. The particular embodiments and applications were chosen and described to provide the best illustration of the principles of the invention and its practical application to thereby enable one of ordinary skill in the art to utilize the invention in various embodiments and with various modifications as are suited to the particular use contemplated. All such changes, modifications, variations, and alterations should therefore be seen as being within the scope of the present invention as determined by the appended claims when interpreted in accordance with the breadth to which they are fairly, legally, and equitably entitled.