Title of Invention

A POUCH FOR MEDICAL DEVICE OR IMPLANT.

Abstract

A pouch (1) for medical device or an implant is disclosed, wherein the pouch (1) comprises two films (2 and 3) with three ends (4, 5 and 6) sealed together and fourth end (7) thereof is provided with an additional film (8), which in-tum is provided with cuts (9) in the center and the one end sealed pouch (10) of which is sealed onto one of the longitudinal side (2) of the three end (4, 5 and 6) sealed pouch (lA) and the another end (11) of which is sealed onto the opposite longitudinal side (3) of the three end (4, 5 and 6) sealed pouch (lA), forming a U-shaped structure (12) inside the three end (4, 5 and 6) sealed pouch (lA) followed by sealing of said fourth end (7) of the said pouch (1 A).

Full Text

FIELD OF THE INVENTION: The present invention relates to ouch for medical device particularly this invention relates to a packing for medical device and to the method of manufacturing thereof BACKGROUND OF THE INVENTION : One of the important packaging modes for packing the medical device is to enclose the said medical device in a pouch made of any thermoplastic film, may be double layer or single layer, may be in a double pouch or a single pouch. Various materials, such as polyethelene, polyethelene-polyester and ehtyl vinyl acetate are used to make the said films, which are sealed, preferably from three ends by peelable or non-peelable seals and the fourth end is sealed after packing the desired medical device, again by peelable seal or by non-peelable seal. The use of thermoplastic film, and of the peelable seal and non-peelable seal will depend on the type of the medical device and on the requirement of sterilisation and on the requirement of ease of opening the said pouch for removing the packed medical device. However, such pouches or some times referred to as packing are not limited to pack the medical devices, but can also be used for packing of the eatables, food products or liquid items. The presently known pouches for packing of the said medical device or any other product, as stated herein above, and the method of manufacturing thereof comprises of manufacturing of pouch from the said films by heat sealing the said films. The known methods of heat sealing are simplest and most reliable methods of making the pouches for packing the said products, by joining the said two films or even some times the tube is drawn, which is sealed from another ends depending upon the need of the pouch. The major limitation of such known methods of manufacturing thereof is that the peelable character of the manufactured pouch is not achieved, that is the resulted pouch is non-peelable, which some times has various limitations, particularly when a medical device or an implant is required to be packed. Some of the drawbacks of such non-peelable pouches are as follows:- The packed product, particularly the medical device or an implant can be removed by cutting one end of the such known pouch, which in-turn can be achieved by the use of pair of scissors or of knive. The use of pair of scissors or of knive in-turn causes contaimination of the packed product, which is the more serious problem in case of the medical device or of the implant. In order to overcome the drawbacks, as described herein above, of such known pouches for packing of the products, particularly the medical device or the implant and of the method of manufacturing thereof, the another type of known such pouches are manufactured after subjecting the said film to a special preparation procedure, that is by applying the adhesive layer on the comers of the film before heat sealing the same. The major drawback of the method of manufacturing of such pouches is that, the sealing of such films is carried out by special methods under specifically controlled conditions, hence the method of manufacturing of such known pouches is relatively more complex and more expensive. The another drawback of such known pouches is that, the cost of the film is increased and further the reliability of the seal is reduced due to the temperature sensitivity of the applied adhesive. In order to over come above drawbacks, the inventor of the present invention has developed a pouch, particularly a double layer pouch, more particularly a double envelop packing for packing of the said products, particularly medical device or the implant, more particularly the copper-T device, tubal ring etc. and has disclosed such packing in the co-pending patent application number 718/Del/96, which discloses a packing, particularly a double layer packing, more particularly a double envelop packing, of which the outer layer, particularly the 0uter envelop is non-peelable heat seal and the inner layer or the inner envelop is peelable heat seal, which over come the limitation of use of pair of scissors or the knive and hence the associated disadvantages thereof Further, the disclosed packing overcomes the major drawback of the non-peelable heat seal, because the product, particularly the medical device or the implant or the copper-T etc is directly packed in the peelable heat seal envelop, which can be easily opened and result in the no-touch facility for removing or if need be for insertion of the packed medical device or the implant. Still further, the disclosed packing overcomes the drawbacks of the use of adhesive film before sealing the said pouch. The method of manufacturing of the inner envelop or pouch of the packing, as disclosed in the above stated co-pending patent application and the improved inner envelop or pouch of the said packing has been disclosed in another co-pending patent application number 348/Del/97 by the inventor of the present invention. This improved inner envelop or pouch of the said packing overcomes some of the disadvantages of the inner envelop or pouch of the said packing, wherein the peelable heat seal sufficiently give sterilisation effect to the packed product, particularly medical device or implant, more particularly the copper-T device with its inserter. However, the above stated inner envelops or the inner pouch of the above stated copending patent applications have limitation of meeting the requirement of the peeling opening forces, which some times may restrict the application areas of such disclosed inner envelops or the inner pouch of the above stated co-pending patent applications. Further, if one desires to have the non-peelable heat seal to overcome the requirement of the peel opening forces, the resulted pouch or the packing, in-addition to have the above stated drawbacks and limitations, may end with higher peel opening forces, which again may result in the rejection of such pouch or the packing, particularly in the packing of sensitive products, which have drawn more attention for packaging. Therefore, the current state of art is limited for peelable or non-peelable heat seal pouch or packing, which have one or the other limitation and/or the drawback or at least do not meet the requirement of peel opening forces. NEED OF THE INVENTION : Therefore, there is a need to have a pouch or a pack, which can over come some of the disadvantages and drawbacks of the prior art, as described herein above. OBJECTS OF THE INVENTION : This is the main object of the present invention to make a complete disclosure of a pouch or of a pack for a product, particularly for a medical device or an implant, which can over come the some of the limitations and drawbacks of the prior art, as described herein above. This is further an object of the present invention to make a complete disclosure of an improved pouch for a product, particularly for a medical device or an implant, which can meet the requirement of the peel opening forces. This is still an object of the present invention to make a disclosure of an improved pouch for a product, particularly for a medical device or an implant, which works on simple scientific principal, and is convenient and simple to manufacture, and easy to use. BRIEF DESCRIPTION OF THE ACCOMPANYING FIGURESr Figure - 1 shows the pouch in accordance to one of the preferred embodiments of the present invention. Figure - lA shows the manner of manufacturing the pouch in accordance to another preferred embodiment of the present invention. Figure - IB shows the pouch in accordance to another preferred embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION: Accordingly, the present invention provides a pouch for medical device or an implant, wherein the said pouch comprises two films with three ends sealed together and the fourth end thereof is provided with an additional film, which in-tum is provided with cuts in the center and the one end sealed pouch of which is sealed onto one of the longitudinal side of the three end sealed pouch and the another end of which is sealed onto the opposite longitudinal side of the said three end sealed pouch, forming a U-shaped structure inside the three end sealed pouch followed by sealing of said fourth end of the said pouch. Accordingly, the present invention discloses an improved pouch for medical device or an implant, particularly it discloses a packing for medical device or an implant and a method of manufacturing thereof, wherein the said pouch comprises of two films with three ends sealed together, preferably by peelable heat seal method or of a single film folded onto itself with two longitudinal sides sealed together, preferably by peelable heat seal method and the fourth end thereof, which is still not sealed is provided with an additional film, preferably of the same material, which in-tum is provided with cuts in the center and the one end of which is sealed onto one of the longitudinal side of the three end sealed pouch and the another end of which is sealed onto the opposite longitudinal side of the said three end sealed pouch, preferably by non-peelable heat seal method forming U-shaped structure inside the three end sealed pouch or the tube form pouch with two longitudinal ends sealed together, with its bottom part, herein after referred to as center, provided with cuts, pointing towards the horizontal sealed end of the three end sealed pouch or the tube form pouch with two longitudinal ends sealed together. The fourth end of the said pouch is then sealed, preferably by peelable heat seal method. Such sealing of the fourth end is preferably provided onto the fourth end and/or onto the area covering the said center part of the said additional film sealed inside the said pouch. Now referring to enclosed figures, the present invention discloses an improved pouch 1 for medical device or an implant and a method of manufacturing thereof, wherein the said pouch I comprises of two films 2 and 3 with three ends 4, 5 and 6 sealed together, preferably by peelable heat seal method. The fourth end 7 thereof, which is still not sealed is provided with an additional film 8, preferably of the same material, which in-turn is provided with cuts 9 in the center and the one end 10 of which is sealed on to one of the longitudinal side 2 of the three ends 4, 5 and 6 sealed pouch lA and the another end 11 of which is sealed on to the opposite longitudinal side 3 of the said three end 4, 5 and 6 sealed pouch lA, preferably by non-pealable heat seal method forming a U-shaped structure 12 inside the three end 4, 5 and 6 sealed pouch I A. The fourth end 7 of the said pouch lA is then sealed, preferably by peelable heat seal method. Such sealing 13 of the fourth end 7 is preferably provided onto the fourth end 7. In accordance to one of the preferred embodiments of the present invention such sealing 13 of the fourth end 7 is preferably provided onto the area covering the said additional film 8 sealed inside the said pouch 1A and said fourth end 7. In accordance to another preferred embodiment of the present invention the said additional film 8 is place into said three end 4, 5 and 6 sealed pouch 1A with its (8) bottom part 14, provided with cuts 9, pointing towards the horizontal sealed end 6 of the three end 4, 5 and 6 sealed pouch lA and is sealed along with the fourth end 7 of the said pouch lA, preferably by peelable heat seal method, in such a way that such sealing 13 (Figvire-1) or 15 (Figure-1 A) is provided onto the area covering the said additional film 8 placed inside the said three end 4, 5 and 6 sealed pouch 1A and the fourth end 7 thereof In accordance to one of the preferred embodiments of the present invention the said pouch may be tube form pouch IA (Figure-IB) with two longitudinal sides 4 and 5 sealed together and said additional film 8 is place into said tube form pouch 1A with its (8) bottom part 14, provided with cuts 9, pointing towards the horizontal unsealed end 6 of the said pouch lA and is sealed along with the fourth end 7 of the said pouch lA, preferably by peelable heat seal method, in such a way that such sealing 15 is provided onto the area covering the said additional film 8 placed inside the said pouch 1A and the fourth end 7 thereof The horizontal unsealed end 6 is sealed thereafter. However, the present invention is not limited by sealing of the said third end 6 after or before sealing of fourth end 7. Further, the present invention is not limited by the type of sealing provided, that is the sealing may be pealable or non-pealable heat seal. Still further, the invention is not limited by material of the pouch. The width of the additional film 8 may be less or more than the width of the pouch 1 A. The present invention has been explained with the help of the accompanying figures, which are not intended to limit the scope of the present invention. It is obvious to those working in this art that various modifications are possible to these without deviating from the scope of the present invention. I Claim : 1. A pouch (1) for medical device or an implant, wherein the said pouch (1) comprises two films (2 and 3) with three ends (4, 5 and 6) sealed together and the fourth end (7) thereof is provided with an additional film (8), which in-tum is provided with cuts (9) in the center and the one end sealed pouch (10) of which is sealed onto one of the longitudinal side (2) of the three end (4, 5 and 6) sealed pouch (1 A) and the another end (11) of which is sealed onto the opposite longitudinal side (3) of the said three end (4, 5 and 6) sealed pouch (lA), forming a U-shaped structure (12) inside the three end (4, 5 and 6) sealed pouch (lA) followed by sealing of said fourth end (7) of the said pouch (1 A). 2. A pouch as claimed in claim 1, wherein said sealing (13) of said fourth end (7) of the said pouch (1 A) is preferably provided onto said fourth end (7). 3. A pouch as claimed in claim 1, wherein said sealing (13) of said fourth end (7) of the said pouch (lA) is preferably provided onto the area covering the said additional film (8) sealed inside said pouch (1 A) and said fourth end (7). 4. A pouch as claimed in claim 1, wherein alternately said additional film (8) is placed into said three end (4, 5 and 6) sealed pouch (1 A) with its bottom part (14), provided with cuts (9), pointing towards the horizontal sealed end (6) of the three end (4, 5 and 6) sealed pouch (1 A) and is sealed along with the fourth end (7) of the said pouch (1 A) in a manner that the sealing (13 or 15) is provided onto the area covering the said additional film (8) placed inside the said three end (4, 5 and 6) sealed pouch (lA) and said fourth end (7) thereof. 5. A pouch as claimed in claim 1, wherein alternately said pouch is tube form pouch (lAO with two longitudinal sides (4 and 5) sealed together and said additional film (8) is placed into said tube form pouch (lA0 with its bottom part (14), provided with cuts (9), pointing towards the horizontal sealed end (6) of the said pouch (lA) and is sealed along with the fourth end (7) of said pouch (lA) in a manner that the sealing (15) is provided onto the area covering the said additional film (8) placed inside the said pouch (lA) and said fourth end (7) thereof 6. A pouch for medical device or an implant substantially as herein described with reference to and as illustrated in the accompanying drawings.

Documents:

741-del-1999-abstract.pdf

741-del-1999-claims.pdf

741-del-1999-complete specification (granded).pdf

741-DEL-1999-Correspondence-Others.pdf

741-del-1999-correspondence-po.pdf

741-del-1999-description (complete).pdf

741-DEL-1999-Description (Provisional).pdf

741-del-1999-drawings.pdf

741-DEL-1999-Form-1.pdf

741-del-1999-form-13.pdf

741-del-1999-form-19.pdf

741-DEL-1999-Form-2.pdf

741-del-1999-form-3.pdf

741-del-1999-form-4.pdf

741-del-1999-form-5.pdf

741-del-1999-gpa.pdf

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