WO2021124357A1

WO2021124357A1 - A mechanical barrier device for medically incorporated instruments

Info

Publication number: WO2021124357A1
Application number: PCT/IN2020/051036
Authority: WO
Inventors: Pankajkumar Kumanbhai Chhatrala; Chintan Ashokbhai Sapovadiaya; Manisha Shivajirao Pawar; Sachin Kishorbhai Makvana
Original assignee: Pankajkumar Kumanbhai Chhatrala
Priority date: 2019-12-19
Filing date: 2020-12-19
Publication date: 2021-06-24

Abstract

The mechanical barrier device for medically incorporated instrument comprising a flexible device, which is placed onto the body where pin sites occur into the body. The present invention relates to medical and surgical device that seals / occludes piercing site or insertion site around implant device and prevents infection and leakage, wherein the outer layer is connected to the top layer and the bottom layer, wherein top layer comprises the inlet orifice, and the outer layer comprises the grip formation, the supporting web and the radially extending flange. The bottom layer of the mechanical barrier comprises the needle outlet layer, gel cavity layer, wound contact layer and the protective layer.

Description

Title: - A MECHANICAL BARRIER DEVICE FOR MEDICALLY INCORPORATED INSTRUMENTS

FIELD OF INVENVENTION

The present invention relates to the medical and surgical device that occludes piercing site or insertion site around implant device and prevents infection and leakage. The present invention relates to medical and surgical device comprising a mechanical barrier, wherein the flexible device comprising an inlet and outlet cavities of implanted device with outer region covered by the protective layer.

BACKGROUND OF INVENTION

Skin is considered as one of the largest organs of the body and protects internal organ from infection or external environment by providing mechanical barrier. Chances of infection is increased when skin is breached intentionally or accidentally.

In Field of Orthopedics, Majority of trauma cases and Bone deformity correction surgery is followed by fixation of broken or abnormal bones externally by putting pins inside bone through skin and hold those pins externally with external fixation/ correction device. Example of such procedure but not limited to external fixation, Illisarove, SUV etc. As Pin Pierces skin, underneath soft tissue is vulnerable to skin infection. As per research data almost 100% cases has pin site infection ranging from 1-4% infection that results into deep bone infection and serious complication. In said systems. Currently dressing material, i.e. gauze is placed around pins to protect infection. Gauze can be treated with different solutions that can prevent infection through skin site. Despite extreme care at pin site, there is a still a chance of developing skin infection through piercing site. Similarly in other specialty such as Cardiology, General medicine, urology, gastro-enter ology, General surgery where device (for example but not limited to IV cannula, Peripheral, central catheter electronic leads, tubes, drain tubes) is placed into body through pierced skin for long term (>14 days) US 5,636,643, discloses a wound drainage device having a liquid- sigkeits- and gas-tight rigid hood which is placed over a wound and fastened outside the edges of the wound on healthy skin. Beneath the hood a foam material is placed on or in the wound. In the hood is from the outside by means of a Vacuum pump creates a negative pressure in order to accelerate wound healing.

WO 1987001027 A1 about the device for assisting wound closure in a surgical procedure in the form of a silicon rubber suture mat and having a front region of generally lenticular shape and an integral narrower tail region, the sides of which are mutually biconcave with respect to the biconvex sides of the front region and are continuously curved therewith. When closing a wound, the front region is used to cover, protect and retain the internal organs by being tucked under adjacent tissue, with the tail region protruding from the wound. After the wound has been almost completely closed, the mat, due to its shape and inherent flexibility may be smoothly removed through a small remaining wound aperture prior to final closure.

US 2004/127835 A1 document discloses a method for producing a wound dressing comprising a perforated silicone gel layer, placing a layer of uncured silicone gel on a flat surface of a drilling device, a plurality of elements extending drilling therefrom, and peeling the silicone gel layer of the puncturing device when at least one surface of the gel layer adjacent to the flat surface silicone has at least partially cured.

In the above mentioned prior art, all the devices used are for the wound closure at the internal organs and for the surgical instruments. There are no instruments for the external piercing implanted devices.

In other instances, dressing is used with paraffin wax which provides mechanical barrier along with hydrophobic surface which helps to keep skin wet and prevents would surface from drying. Polyurethane film adhesive patches i.e. Tagaderm® is used for surgical wound protection in order to keep incision clean during surgery but it has very limited role in pin site incision because of tubular structure is difficult to be covered with films or routine dressings from perimeter surface.

There are no particular barriers to dress, which prevents the infection by means of mechanical barriers. Some researcher tried a gauze dressing impregnated with antibiotic, antibacterial or bactericidal chemical, drugs but in such cases preemptive effect reduces over the period of time. Because of lack of standard process, there is always a chance of infection varies from case to case and person to person. In few cases, these dressings are not effective when the bacterial species are resistant to said chemicals or drugs.

The present invention solves the above mentioned problems, wherein the present invention having a simple structure which can be easily be fixed or removed from the human body. The present invention is very economical wherein a flexible rubber is used which can reduce the infections. SUMMARY OF THE INVENTION

The principle object of the present invention is to provide a mechanical barrier comprising the top layer, the outer layer and the bottom layer wherein the outer layer of said device is connected to the top layer and the bottom layer as the supporting structure, wherein top layer comprises the inlet orifice for the entry of the external fixation pin wherein the outer layer comprises the grip formation region, supporting web structure and the radially extending region. The inlet orifice allows the external fixation pin to enter into the mechanical barrier. The radially extending region of the outer layer is connected with the supporting web structure and the bottom layer, which will constitute to the strength and stability of the mechanical barrier. The bottom layer of the mechanical barrier comprises the outlet orifice, gel cavity layer, wound contact layer and the protective layer wherein the composite gel housing is located at the bottom of the device wherein outlet orifice is located inside the composite gel cavity region.

One of the objects of the present invention provides a mechanical barrier, wherein the mechanical barrier comprises of flexible body, which consists of the inlet orifice and outlet orifice and a sealing subsystem of barrier.

One of the objects of the present invention consisting of a structure for assisting the medical implant management, in which a flexible mechanical barrier device consisting a main front region (Inlet Orifice), wherein the implanted device enters through the inlet orifice portion and leaves by means of outlet orifice which is included in the integrated guide of the mechanical barrier.

One of the objects of the present invention is to provide a flexible mechanical barrier consisting a silicon film adhesive or any alike adhesive thereof used for the skin adhesion treatments.

One of the objects of the present invention provides a flexible mechanical barrier, wherein flexible mechanical barrier is fixed to skin by means of thin skin adhesive such as film coated and silicon layer adhesives or any adhesive thereof used for skin adhesion treatments.

One of the objects of the present invention is to provide a flexible mechanical barrier applied over shaft present in the device wherein shaft is inserted into the human body.

One of the objects of the present invention is to reduce infection by providing a mechanical barrier by means of a flexible material stopper supported with coated film.

One of the objects of the present invention consists an integrated supporting member inside the flexible mechanical barrier, wherein the implanted device directly enters and exits from the inlet orifice and outlet orifice respectively.

The combined effect of this shaping, with the inherent flexibility of the base material employed, leads to the advantageous result that the main body portion may be readily removed after substantial occlusive management since it offers little resistance to the confining and restraining influences of the restricted wound aperture through which it is extracted but readily yields to these forces, without causing damage to the partially closed wound.

One of the objects of the present invention is to experience a painless treatment. The present invention consisting a reverse cone shape flexible mechanical barrier device with attached film material wherein there is an adhesive to support the device as well as adhere to the outer body portion.

One of the objects of the present invention consisting of a gel form at inner side of the flexible mechanical barrier, in which surgical gel is placed.

One of the objects of the present invention wherein the radially extending region is provided with a flexible element defined by a film generally concentric with the periphery of the absorbent core and extending outwards relative to the distal surface of the absorbent core. The incorporation of the flexible element on the radially extending region allows the improved accommodation of the expansion of the wound dressing.

Such device can be used for preventing infection through external fixation pin insertion site in orthopedics, Catheter insertion site in Critical care, chemo therapy, or any other fluid exchange transfer device placed into the body for longer term, cardiac leads or pacemaker leads, dialysis cannula, etc.

BRIEF DESCRIPTION OF DRAWING

The extra ordinary features may be better understood by referring to the following description taken in conjunction with the accompanying drawings. The drawings are not necessarily to scale, emphasis instead generally being placed upon illustrating the principles of the technology.

Figure 1: Sectional view of the mechanical barrier device.

Figure 2: Isometric view and top view of the mechanical barrier device.

Figure 3: Perspective view showing of a wound dressing.

Figure 4: Center line with tubes for Superior vena cava treatment.

Figure 5: Drain tube with Flexible mechanical barrier

Figure 6: Link of External Fixator Assembly with connect silicon rubber stopper. Figure 7: Inserted Cannula from the flexible mechanical barrier.

Figure 8: Trocar attachment at various medical instruments.

Figure 9: Illustrate trocar in the mechanical barrier. Figure 10: Cannula inserted into flexible mechanical barrier with the trocar.

Figure 11: Exploded view of the inserted trocar into the mechanical barrier.

Figure 12: Cross - Sectional view of the mechanical barrier.

Figure 13: Mechanical barrier attached to the body at various medical treatments.

Figure 14: Cross-Sectional View of the inserted trocar with cannula

Figure 15: Sectional view of the mechanical barrier device with the guideway

While the invention will be described in connection with preferred embodiments, it will be understood that it is not intended to limit the invention to these embodiments. On the contrary, it is intended to cover all alternatives, modifications and equivalents as may be included within the spirit and scope of the invention as defined by the appended claims. Furthermore, skilled artisans will appreciate that elements in the figures are illustrated for simplicity and clarity and have not necessarily been drawn to scale. For example, the dimensions of some of the elements in the figures may be exaggerated relative to other elements to help to improve understanding of the various embodiments of the present invention or to better illustrate surfaces with shading lines, etc. (e.g., the size of the body, spine and/or ribs may be exaggerated with respect to one another or other components in order to make the drawing more clearly-show what is being claimed). Also, common but well-understood elements that are useful or necessary in a commercially feasible embodiment are typically not depicted in order to facilitate a less obstructed view of these various embodiments of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

The main embodiment of the present invention provides a flexible mechanical barrier 100, wherein flexible mechanical barrier 100 is implanted between piercing sites (Pin Sites) implanted device and external part of the human body.

The other embodiment of the present invention provides a flexible mechanical barrier, in which mechanical barrier structure consists of implanted device inserted from the inlet orifice 1 and guided implanted device by provided gel cavity layer 7 and exit from the outlet orifice 8. The principle embodiment of the present invention is to provide a device for assisting occlusive wound management in a surgical procedure, said device consisting exclusively a body of flexible rubber material having a main front region with smoothly curved sides shaped and configured inserted under adjacent body tissue during occlusive to cover and retain internal surgical instrument exposed by the wound, and a tail region narrow than said front region and is integrated for enabling the said body to be moved freely through a remaining wound aperture wherein the wound has been substantially closed.

The other embodiment of the present invention provides a flexible mechanical barrier 100 consisting of PU Film 14 coating with silicon layer adhesive. Wherein PU Film 14 layer is placed on the outer area of flexible mechanical barrier 100. The present invention consists of PU Film 14 with adhesive which can easily adhere and can be detached from the human skin.

In addition, according to the study, due to the greater tension on both sides of the skin of incision, it creates pressure ischemia at a high tension side, as a result necrosis of tissue precipitates.

One of the embodiments show the flexible mechanical barrier 100 as a separate piece molded into the outer body of the provided film 14, wherein it should be understood that in alternate forms of the adhesive and the flexible barrier 100 could be integrally formed from the same material making-up the rest of the flexible body if required. The rigidity of the flexible mechanical barrier 100 in such an embodiment would come from the greater thickness of the material at the provided Film 14 location as compared to the remaining portion of the outer body. In other forms, the rigidity of the flexible mechanical barrier 100 may not be an issue or a necessary consideration and, thus, a body and flexible mechanical barrier 100 of uniform thickness may be used. Similarly, it should be understood that the flexible body could itself be tapered from rear to front (or rearward portion to forward portion) to further make the adhesive easier to remove from the portion of the wound that remains open when the adhesive is to be removed. For example, both the forward portion of the flexible mechanical barrier 100 and forward portion of the flexible body could be formed with a continuing taper (meaning the taper of the outer body could be configured to follow, continue or track the taper of the flexible mechanical barrier) so that the forward portions, are more easily directed to and pulled through the remaining opening of the wound till it has been partially or mostly closed. This arrangement will enable to the minimal wound opening periphery which has to be closed after the removal of the surgical aid. The present invention will allow the tapering of the body in width, height, or both dimensions.

One of the embodiments of flexible mechanical barrier, includes the body and tail portions of the flexible mechanical barrier 100 integrally formed from a single sheet of material. This reduces manufacturing cost. This region is merely a narrow section of the same material that could be folded or rolled as required through a small opening in the wound. The material is preferably of thickness between 1 to 5 mm, and more preferably between desired lengths. As per flexible mechanical barrier 100 the end of the tail region is inwardly curved to match the tip. It may be seen from Figures 6 and 9, which depicts the use of the device in abdominal surgery that the device as above described may be slipped at the extending organs joint with the tail region extending from the wound and the front region covering as well as protecting the infection. To enable the Fixation Pin 13 to be completely covered where the tail region exits from the wound, the tail overlaps the front region so that the sheet material \ Film 14 of the front region may be tucked under the surrounding tissue at this exit point, while the narrowing portion of the tail at any widening of the body cavity is avoided. The taper illustrated for flexible mechanical barrier 100 is a tapering of the width of the occlusive so that the width of the flexible mechanical barrier 100 wherein the rear portion is greater than the width of the occlusive section of the front portion. It should be appreciated, however, that in alternate embodiments the tapering could be a tapering of the height of the flexible mechanical barrier 100 at the forward portion of either or in addition to the tapering of the width of the forward portion of flexible mechanical barrier. Thus, in some forms, the flexible mechanical barrier 100 may taper in width wherein the forward portion , while in other forms, the flexible mechanical barrier 100 may taper in height only toward the forward portion, while in still other forms, the flexible mechanical barrier 100 taper in both width and height towards the forward portion of flexible mechanical barrier 100. Wherein silicon rubber having a high bending capacity, heat resistance, radiation resistance, good weather ability, cold resistance, as well as this device is insulator of electricity, so that this present invention is vastly benefits to wound closure.

A flexible mechanical barrier 100 reduces the orthostatic hypotension due to aditus having a sufficient space at inner side of flexible mechanical barrier to solve the above problem, so that the patient can work flexibly.

One of the embodiments of the present invention is to provide a system that includes a dressing assembly as a flexible mechanical barrier, wherein it includes a shaped dressing bolster, a sealing subsystem, and a reduced blood pressure. The flexible mechanical barrier 100 develops a net compressive force, represented by reference numerals that is realized at the subcutaneous tissue. As described further below, the dressing bolster may be casted and configured to allow the compressive force to be distributed evenly over the patient's epidermis and beneath the epidermis. Otherwise, if there are areas of substantially increased force as compared to other areas, skin irritations may result. The device may also be operable to develop an inward force (or closing force), i.e. towards an interior portion of dressing assembly. The inward force is represented by reference numerals. The inward force may remain substantially within the plane of the epidermis. In other words, the inward force operates mainly within the epidermis. In addition, the system is operable to deliver reduced pressure to the incision. The reduced pressure may be realized at the level of the hypodermic void to help the tissues to bring together in that region and also to get rid of any air or other fluids including exudates.

One of the embodiments of the present invention provided is the dressing assembly which includes the casted dressing bolster, which has a primary side and a secondary, inward (tissue-facing) side. The casted dressing bolster may be modified substantially to match the estimated area of undermined hypodermic tissue although a larger or smaller size may be used. The casted dressing bolster has a peripheral edge and the shaped dressing bolster may be made of a number of different bolster materials. In one illustrative embodiment, the shaped dressing bolster is made from a porous and permeable foam-like material and, more particularly, a reticulated, open cell polyurethane or polyether foam that allows good permeability of wound fluids while under a reduced pressure. Any material or combination of materials might be used for the bolster material provided that the bolster material is operable to distribute the reduced pressure and provide the desired forces.

One of the embodiments of the present invention of the shaped dressing bolster may be a manifold that is sized and shaped to distribute forces evenly and to distribute reduced pressure. The term "manifold" as used herein generally refers to a substance or structure that is provided to assist in applying reduced pressure to, delivering fluids to, or removing fluids from a piercing site. The manifold typically includes a plurality of flow channels or pathways that are interconnected to improve distribution of fluids provided to and removed from the piercing site around the manifold. The manifold may be a biocompatible material that is capable of being placed in contact with the tissue site and distributing reduced pressure to the tissue site.

One of the embodiment of the present invention consisting of the sealing subsystem includes an over-drape sealing member. The over-drape may be an elastomeric material or may be any material that provides a fluid seal. "Fluid seal," or "seal," means a seal adequate to hold reduced pressure at a desired site given the particular reduced-pressure subsystem involved. "Elastomeric" means having the properties of an elastomer and generally refers to a polymeric material that has rubber-like properties. More specifically, most elastomers have elongation rates greater than 100% and a significant amount of resilience. The resilience of a material refers to the material's ability to recover from an elastic deformation. Examples of elastomers may include, but are not limited to, natural rubbers, polyisoprene, styrene butadiene rubber, chloroprene rubber, polybutadiene, nitrile rubber, butyl rubber, ethylene propylene rubber, ethylene propylene diene monomer, chlorosulfonated polyethylene, polysulfide rubber, polyurethane, EVA film, co-polyester, and silicones.

One of the embodiment of the present invention provided the dressing bolster and any additional layers such as the interior surface member and the exterior surface member may be covered with an occlusive layer, which is a part of sealing subsystem and the over-drape may extend beyond peripheral edges, which has a primary side and a secondary side. A fluid seal may be formed between the drape extension and the patient's epidermis by using a sealing apparatus, such as a sealing tape, or drape tape, an adhesive paste, hydrocolloid, hydrogel, or other sealing means. The drape tape includes an adhesive. In some applications, a gasket material might be added between the epidermis and the dressing bolster or the over-drape. In another embodiment, the over-drape may be applied only on the first side of the dressing bolster, and then a wide drape tape used to seal the edges, or peripheral portion, of the dressing bolster with or without extensions.

One of the embodiments of the present invention provided sealing subsystem provides a fluid seal, or otherwise allows the system to maintain reduced pressure at the desired treatment site. The sealing subsystem preferably includes the over-drape and the sealing apparatus. While described as forming a fluid seal, there may be some leakages and the resultant small air leaks which provides a low velocity airflow throughout the dressing assembly that is distributed and helps to remove moisture. In an alternative embodiment, instead of using the over-drape, the exterior surface member may be made to have an airtight exterior portion and drape tape may be directed to cover the edges of the bolster material as well other portions that are not otherwise sealed.

One of the embodiments of the present invention is that the inlet orifice allows the external fixation pin to enter into the mechanical barrier within the guide way 12 as it allows the external fixation pin to move in a specific direction by avoiding the random directions of the needle.

Wound dressing generally includes a contact layer, guide ways and a cover layer. Cover layer includes an occlusive layer and a portal member. Portal member is configured to establish fluid communication between vacuum reservoir and vacuum system by providing an interface for a suction device such as vacuum tube. Each layer of wound dressing is described in greater detail below.

One of the embodiment of the present invention provided a protectors of the barrier, wherein barrier wound protectors have also been employed to prevent the egress of bacteria into the incision, but this is merely a passive approach, and considering the barrier protection must be removed to complete the operation, the incision is inevitably exposed to the infectious contents within the surgical field. Additionally, wound protectors may be difficult to manipulate, especially when positioned in the surgical field. A further drawback is that the barrier can also trap bacteria onto the wound surface, allowing bacteria to proliferate in the wound space.

Contact layer may be sufficiently conformable to be positioned in direct contact with an irregularly shaped surface of a wound bed. A thin film of polyethylene or other suitable non-adherent material may form the contact layer to limit the adherence of filler and other substances to the wound. Apertures or perforations in the film permit fluids to pass through the contact layer allowing for the sub -atmospheric pressure to penetrate into the wound and discharges to flow freely out of the wound. By selecting an appropriate film material, the passage of wound discharges through contact layer which may be controlled so as to be substantially unidirectional to prevent wound discharge from flowing back into the wound. Unidirectional flow of exudates may also be promoted by the selection of other materials including a lamination of layers having varying absorptive characteristics.

As per the Figure 1, which disclose the schematic diagram of particular invention with nomenclature. The flexible mechanical barrier 100 consisting one inlet opening orifice and one outlet part, which designated name with Inlet orifice 1 and outlet orifice 8 respectively. The present invention adheres on the body by provided PU film 14. The present invention flexible mechanical barrier 100 having a curve shaped of the outer portion of the radially extending region 4 is. Radially extending region 4 consisting PU film 14 with adhesive layer, which adhere very easily and can be detached as per the requirement. The present invention flexible mechanical barrier 100 having an opening part for external fixation pin 13 and other activities can be of any shape including circular, pentagonal, hexagonal, triangular etc. The present invention flexible mechanical barrier 100 having a different size of the outlet orifice 8 include circular, pentagonal, hexagonal, triangular etc.

As per the figure 2 which describes the main embodiment of the flexible mechanical barrier. The present invention mainly consisting flexible mechanical barrier 100, wherein extended Fixation Pin 13 is covered by flexible mechanical barrier 100, wherein first of all flexible mechanical barrier 100 adhereson the outer portion of the human body by using adhesive material. The present invention also consisting PU Film 14 on the flexible mechanical barrier 100 which supports, so that PU Film 14 works as a supporting member in the present invention. The PU Film 14 having a round, square shape, hexagonal, octagonal shape can be used as per requirement of wound closure. Also, silicon rubber having a different tail shape like round, square, rectangle, pentagonal, hexagonal, octagonal etc., can be used as per the requirement of the wound closure. Flexible mechanical barrier 100 having a tapper portion at the bottom or adhere side of the device, due to strong support to adhere on member of the human body as well as easily remove from the body. The present invention having another application in a stick on the hole when drain the water from the human body, so that back up of the water is reduced which in turn avoids the infections which may be occurred during the surgery. The present figure shows the application utilize in the pyothorax, pneumothorex, hemothorax and other medical treatments.

As per the Figure 3, extended Fixation Pin 13 is open at both sides of the human body, where organs are joint with this link. The flexible mechanical barrier 100 is adhere on the outer portion of the human body with PU Film 14 with silicon layer and adhesive to use as a support as well as to adhere easily. Flexible mechanical barrier 100 having a good property of the elasticity and ductility, so that once a Fixation Pin 13 is inserted in the flexible mechanical barrier 100, they cannot move in the upper and lower portion. This device can reduce the chances of infections from the surroundings. As per the Figure 4, that illustrate central line of the thin, flexible tube is inserted into a vein, usually below the collarbone. It is guided (threaded) into a large vein_above the right side of the heart called the superior vena cava. The flexible mechanical barrier is attached at the central venous catheter inserted into the body.

The Figure 5, disclose the angle provided for the flexible mechanical barrier. That describes the trocar 16 or other medical implanted devices inserted into the body at an inclined angle, the flexible mechanical barrier adjusted as per implanted device due to its charterships of the material. The present figure illustrates construction, shapes and size of the flexible mechanical barrier vary from as per requirement. The present figure shows the angle between 30°-60°.

According to Figure 6, that discloses the application of cannula. For particular application, the present invention used to prevent infections from the discharge of blood and others in any form. Also, the present invention stops the discharge due to the generated pressure of the blood as per present Figure 6. The present Figure 6 disclose also the uses of particular invention like blood transfusion or other medical issues, to give glucose by the cannula tubes and other resources.

Figure 7 describes top view of the flexible mechanical barrier 100. Flexible mechanical barrier 100 top view consisting of the layer, in which it depicts the inlet orifice 1 ,the protective layer 5, the wound contact layer 6 and the gel cavity layer 7.

Figure 8 discloses the isometric view of the present invention flexible mechanical barrier 100. The present figure discloses the inlet orifice 1, radially extending region 4 and PU film 14 with coated silver adhesive.

As per the Figure 9, that disclose the application of the mechanical barrier in different areas.

As per the Figure 10, that discloses the needle orifice. Also, the present Figure 9, sharped edge needle to use to create hole in the mechanical barrier 2. That describes the various supporting components while implanted medical instruments and that components guide to the implanted device.

As per the Figure 11, which describes process to create hole in the mechanical barrier. Trocar 16 inserted into the mechanical barrier, due to existing sharp edge at the end portion of trocar 16. The present figure also consists cannula attached with the trocar 16, so force applied on trocar 16 while to create the hole in inlet orifice 1.

As per the Figure 12, that disclose the process after the removal of trocar 16 from the cannula 15. The present figure shows the cannula 15 out from the flexible mechanical barrier 100 using trocar , so while applying the cannula for blood or other activities, which easily passes through by means of silicon rubber .

As per the Figure 13, that illustrate cross sectional view of the mechanical barrier 100 which includes the cannula 15 is inserted into the body with trocar 16. Trocar 16 inserted into the flexible mechanical barrier 100 said comprising a cannula 15 for draining or to put into the body.

Figure 14 describes the external fixation pin extension from the body used more than one to link or joint to organs in the human body by using external fixation assembly, wherein flexible mechanical barrier 100 can be used to adhere on the human body while this type of joint is needed.

As per the Figure 15, it illustrates the sectional view of the mechanical barrier in along with the provision of the guide way 15. The guide way will allow the external fixation pin to move in the specific direction which will be helpful in various treatments.

There are various flexible and elastic martials used as a use in flexible mechanical barrier 2, like EPDM, silicon rubber, neoprene rubber, Viton, Natural rubber, nitrile rubber, butyl rubber, timprene, sponge rubber, foam rubber, rigid and flexible PVC, thermoplastic Elastomers... also various manufacture. One of the embodiments of the present invention is to use silicon gels as a skin adherent layer. Adhesives have lightly cross-linked polysiloxane three-dimensional networks. Once suitably cross-linked, adhesive are solids that retain their form without external containment. The chemical reaction which forms the gel is irreversible. Prior to curing, a curable adhesive is a precursor fluid mixture. The adhesive reaction is not a linear process. At the point where at the adhesive cures to a gel, a 3-D network is formed and mechanical tests will show that the adhesive has transformed into a weak, very soft viscoelastic solid. Further reaction increases the stiffness and strength of the solid, though it remains soft. The reaction is taken to completion so that the product is stable and has no reactive chemical groups. The reaction rate slows towards the end as there are no reactive groups left.

Table of various infection occurs during various medical treatments: -

The above mentioned table explains about the various infections that can be caused by the particular treatment process. Incident A occurs while injury to the pleura, with air introduced into the pleural space secondary to diagnostic or therapeutic medical intervention, due to this type of problem can be solved tube insertion with positive pressure ventilation. As per above citation, Iatrogenic Pneumothorax occurs in 1.36% of cases. If Current invention is applied at time of Thoracotomy tube insertion, rate of Iatrogenic Pneumothorax can be reduced significantly up to 0.60% or even less.

Incident B shows rate of infection at site of Thoracotomy tube inserted for various therapeutic purpose i.e. Pneumothorax, pyothorax, hemothorax etc. Overall, 7.7% cases suffer from such kind of infection and it accounts for additional burden of hospital stay and therapeutic expense to cure infection. With additional care of insertion site along with use of invented device can reduce infection rate up to 2% of cases

Central line placement uses in almost all critically ill patient in cardiology and organ failure patients, to deliver fluid and Medicines directly into heart. Incident C shows Rate of infection through Central line even after aseptic measures in ICUs and ICCUs. Around 25% of infection accounts for infection associated mortality in central line placement patient. As above invention is convenient and adds additional protection barrier, burden of infection associated mortality can be significantly reduced.

Peripheral Vein Cannula is one of first procedure done after patent’s hospital admission. Venous access allows sampling of blood, as well as administration of fluids, medications, parenteral nutrition, chemotherapy, and blood products. Incident D shows rate of Thrombophlebitis which is around 25 to 50% of all cannula insertion. Thrombophlebitis is the inflammation of a vein with blood clot formation inside the vein at the site of the inflammation. Thrombophlebitis also is known as phlebitis, phlebothrombosis, and venous thrombosis. Orthopedic pins are rods having sharp points. Pins are inserted into fractured bones in order to keep them aligned with fracture site. Pins are inserted percutaneously in to the bones, incident E shows pin sites infection occurred, and around 11.3 to 100% patients are infected. Above mentioned infections can be reduced by the flexible mechanical barrier. Wherein mechanical barrier is attached before medical instruments which are inserted into the body. Also, the mechanical barrier can be moulded in any shape as per the requirement which can be prevent maximum infections and can improve the medical treatment procedure.

Claims

CLAIMS We claim,

[CLAIM 1] A mechanical barrier device 100 for medically incorporated instrument comprises: a) the top layer 101 comprises the inlet orifice 1; b) the outer layer 102 comprises :

I. grip formation region 2, connected to the top layer 101 and the supporting web structure 3,

II. supporting web structure 3 is located in between the grip formation region 2 and the radially extending region 4,

III. radially extending region 4 is located in between the supporting web structure 3 extending up to the bottom layer 103, c) the bottom layer 103 comprises:

I. the protective layer 5 is located within the outer periphery of the said device and the wound contact layer

6 ;

II. the wound contact layer 6 is located in between the protective layer 5 and the gel cavity layer;

III. the gel cavity layer 7 is located in between the wound contact layer 6 and the outlet orifice 8 ;

IV. the outlet orifice 8; wherein a surgical gel 9 comprises: a) composite gel house 10 wherein a slit in substantial registration to said device , allowing the external fixation pin to pass inwards and outwards within gel cavity region; b) said surgical gel 9 is filled in the said composite gel house 10.

[CLAIM 2] A mechanical barrier device 100 as claimed in claim 1 wherein the inlet orifice 1 having the different sizes and shapes of the top portion have to drill in advance for the required applications, if predrill or wire hole is not provided.

[CLAIM 3] A mechanical barrier device 100 as claimed in claim 1 wherein there is an inlet orifice 1 for the insertion of the eternal fixation pin 13 during the treatment.

[CLAIM 4] A mechanical barrier device 100 as claimed in claim 1 wherein the external fixation pin 13 enters into the inlet orifice 1 and slides into said mechanical barrier device 100 and come out of the outlet orifice 8 to meet perfectly within a cannula 15.

[CLAIM 5] A mechanical barrier device 100 as claimed in claim 1 wherein there is a radially extending region 8 and connected to the bottom layer 103 and the supporting web structure 3 in such a way that the medical instruments are properly inserted into the body during the different types of the treatments.

[CLAIM 6] A mechanical barrier device 100 as claimed in claim 1 wherein a composite gel house 10 is set up at the bottom layer 103 and guided along the supporting web structure 7.

[CLAIM 7] A mechanical barrier device 100 as claimed in claim 1 wherein said composite gel house 10 allowing the substantial registration of the external fixation pin 13 to pass within and allowing the inward and outward movements.

[CLAIM 8] A mechanical barrier device 100 for medically incorporated instruments method involves: a) inserting a medically implanted device relative to a wound opening, wherein the flexible mechanical barrier 100 comprising an elastically filler material; b) extending an occlusive layer outwards beyond an outer perimeter of the pin sites or wound sites wherein the bottom layer 103 positioned beneath to adhere to the body; c) wherein applying a negative pressure to the mechanical barrier 100 to expand the material and displace the occlusive layer at a wound margin to facilitate closure of the wound.

[CLAIM 9] A mechanical barrier device 100 as claimed in claim 1 wherein the flexible material is made out of silicon rubber or any medical grade elastomer.

[CLAIM 10] A mechanical barrier device 100 as claimed in claim 1 wherein the external fixation pin 13 in the compressive flexible mechanical barrier 100 , that serves as a mechanism to provide the compressive wound dressing, within a closed environment, around a surgical external fixation pin 13 or tube often used during the fixation of fractured bones or whenever surgical fixation pin 13 to follow the surgical procedures wherein a plastic cup representing the wound dressing consists of various geometric shapes , designed in part to couple with the wound dressing material or sponge of a specific size and shape, a central pin hole to allow the fixation pin 13 or wire to pass through the wound dressing wherein comes in direct contact with the wound dressing material or sponge or gel, a pin stem which extends upward from the central pin hole allowing it to receive and stabilize the orthopedic pin or wire as it passes through the hollow center wherein an opening stopper that prevents the wound dressing housing from opening beyond its functional capability.

[CLAIM 11] A mechanical barrier device 100 as claimed in claim 1 wherein trocar 16 inscribed into the mechanical barrier 100 from the inlet orifice 1 portion.

[CLAIM 12] A mechanical barrier device 100 as claimed in claim 1, wherein trocar 16 revoked from the outlet orifice 8 of the mechanical barrier 100.

[CLAIM 13] A mechanical barrier device 100 as claimed in claim 1, wherein having a gel layer 4, so as to reduce the stress concentration and improve the inner strength of the said device and provides ability to create air tight seal on removing of implanted device.

[CLAIM 14] A mechanical barrier device 100 as claimed in claim 1 wherein the surgical gel 9 will give the soothing effect to the patient during the treatment.

[CLAIM 15] A mechanical barrier device 100 as claimed in claim 1 adheres to the body by means of PU film 14 and other alike adhesives.

[CLAIM 16] A mechanical barrier device 100 as claimed in claim 1, wherein the cannula 15 entered into the mechanical barrier 100 within and adheres to the trocar 16 or other sharpen edged medical instruments.

[CLAIM 17] A mechanical barrier device 100 as claimed in claim 1, wherein a multilayer made of silicon elastomer and other elastic materials and can have any shape.

[CLAIM 18] A mechanical barrier device 100 as claimed in claim 1, where in flexible mechanical barrier 100 can also be transparent and elastic wherein the insertion site or pin site can be directly visualized through dressing, without the extraction of the dressing process.

[CLAIM 19] A mechanical barrier device 100 as claimed in claim 1, wherein an adjustable wound closure flexible mechanical barrier to dilate a surgical wound incision to a desired diameter.