Title of Invention

"A SYSTEM FOR AUTOMATED ASEPTIC FUSION AND CONNECTION OF TUBES"

Abstract

The present invention relates to an improved method for making sterile connection between two interconnectable medical devices resulting in better quality of weld. Additionally the present invention relates to a low cost heater element for making sterile connection between two interconnectable medical tubing made out of same thermoplastic material. It is a method used for forming a sterile/aseptic and contamination free sealing connection of two thermoplastic inter connectable tubes, particularly used in medical devices like Blood Bag systems and CAPD Bag systems Fig.-F

Full Text

Field of Invention The present invention relates to an improved method for making sterile connection between two interconnectable medical devices. More specifically the present invention relates to a low cost heater element suitable for heating and welding two thermoplastic tubes together. Also it is a method used for forming a sterile/aseptic and contamination free sealing connection of two thermoplastic inter connectable tubes, particularly used in medical devices like Blood bag systems and CAPD Bag systems ( Continuous Ambulatory Peritoneal Dialysis Bag systems). The blood bag systems can be of various sizes and configuration with or without leucodepletion filters for blood or its components and shall include all the integral labside or bed side applications. The two tubes to be connected will be manufactured from the same material or its formulation. The equipment and the method covered in the above invention results in forming a uniform sterile or aseptic connection between two tubes such that after connection, it will allow the free passage of fluids within them. Background of Invention At the present time there are a number of medical and scientific procedures which require a sterile transfer of fluids from one container to another. For example, during the connection of tubes of a blood collecting bag and a blood component bag in a blood transfusion system, replacement of waste liquid bag with dialysate bag and other operations in CAPD, it is necessary to connect tubes under a sterilized condition. In recent years there has been an increasing demand for blood transfusion. Blood contains a number of essential components which are required in blood transfusion. The collection of blood from donor requires a sterile environment. Since various bacteria and viruses pass through blood transfusion, the whole process of transfusion should be done in aseptic or sterile environment. Bacterial contamination of blood and its cellular components remains an unresolved problem in transfusion medicine and is considered to be the most common microbiological cause of transfusion associated morbidity and mortality. This is because contaminated units may contain large numbers of virulent bacteria as well as endotoxins that are considered to be fatal to the recipient. Accordingly, measures have been proposed to prevent or at least control the potential risk of transfusion associated bacteria infections. Broadly, these approaches include: bacterial avoidance; bacterial growth inhibition and bacterial load reduction by leucofiltration/viral inactivation. Bacterial contamination of transfusion products, especially platelets, is a longstanding problem that has been partially controlled through modern phlebotomy practices, refrigeration of red cells, freezing of plasma and improved materials for transfusion product collection and storage. Bacterial contamination of platelet products has been acknowledged as the most frequent infectious risk from transfusion occurring in approximately 1 of 2000-3000 whole-blood derived, random donor platelets, and apheresis-derived, single donor platelets. In the US, bacterial contamination is considered the second most common cause of death overall from transfusion (after clerical errors) with mortality rates ranging from 1:20000 to 1:85000 donor exposures. Estimates of severe morbidity and mortality range from 100 to 150 transfused individuals each year. If during collection of blood from donor, contamination of blood by virus or bacteria get occur, they will pass to recipient and can result in post transfusion disease. Normally the contamination occurs during the transfer of bloods in different compartments of blood bags or during storage period. The exposure of bacteria occurs during the sealing of different compartments. So there is a need to provide an efficient system for providing contamination free or aseptic sealing of two interconnecting means used in medical equipments. Prior Arts US 5888328: This is the patent which relates to a kit for testing the integrity of sterile tubing welds made by a sterile tubing welding machine employing welding wafers includes a plurality of tubing samples, and a container having a series of receptacles for holding the tubing samples and the wafers used in the sterile tubing welding machine. A set of instructions is provided for making the sterile tubing welds with the tubing samples in the container, and a data sheet is included for recording particulars of the kit and reporting a weld analysis. US 4157723: This patent relates to a connection may be formed between sealed conduits in which each conduit carries an opaque, thermoplastic wall portion preferably having a melting range above essentially 200.degree C, preferably with the opaque thermoplastic wall portions being carried on the conduit about their periphery by transparent wall portions of the conduit. The opaque wall portions of the conduits are brought together into facing contact, and then exposed to sufficient radiant energy to cause the opaque wall portions to fuse together, and to open an aperture through the fused wall portions. This provides sealed communication between the interiors of the conduits. US 2005/0211373 A1: This is the patent application where a method for sterile connection of tubing includes welding the tubing sections together using an efficient laser is described. The ends of the tubing sections are brought together prior to the initiation of welding, facilitating isolation of interior passage of the tubing sections. The method can be carried out by an apparatus which is relatively inexpensive and compact. US 4610670: In this patent a process, apparatus and system for making a sterile connection between thermoplastic resin tubes is disclosed. A section of each tube is flattened and a hot cutting means is urged through the flattened sections so as to seal temporarily each tube and to provide molten tube ends. The tubes are aligned with each other and then the desired molten tube ends are urged together to form a joint between the tubes for each pair of tube ends to be connected. Each joint is cooled and then subjected to light stress to open the temporary seal in each tube, thereby providing fluid communication between the joined tubes. US 3968195: This patent relates to a method for making a sterile connection between fluid passage means such as a port structure for passing sterile fluids or other biological material. The port structure includes a flexible sleeve having a rigid thermoplastic tube secured therein. The outer surface of the sleeve has greater thermoplastic properties than the inner surface, enabling the sleeve to be heat sealed to the fluid passage means without sealing off the inner surface. The rigid tube has a free end extending outside the sleeve, having a thermoplastic diaphragm which seals off the free end. When a sterile connection between two fluid passage means incorporating the port structure is desired, the free ends of each rigid tube are aligned and softened, and each thermoplastic diaphragm is opened. The free ends of the rigid tubes are then brought into contact and held in position under a slight pressure while the thermoplastic tubes cool and solidify, thereby creating a permanent connection. JP 6091011 (A): This patent relates to process to facilitate the cleaning work of a tube forming material stuck to the inner surfaces of clamps by moving a second clamp movement mechanism in a direction in which it goes away from a first clamp by pushing a second clamp in a state in which the first clamp has moved in parallel with the second clamp so that the fellow end portions of flexible tubes which are to be connected to each other may face each other. In the case of an aseptic connection device for flexible tubes, at least two flexible tubes are held in a parallel state by means of clamps 2, 3, and flexible tubes 48, 49 are cut off between the clamps 2, 3 by means of a cutting-off device 5.; At least one of the clamps 2, 3 is moved by means of a drive means so that the fellow end portions of the cut-off flexible tubes 48, 49 that are to be connected to each other may be stuck closely to each other, and the cutting-off means 5 is moved up and down between the clamps 2, 3 by means of a cutting-off means driving means. A second clamp movement mechanism is made movable in a direction in which it goes away from the first clamp 3 by pushing the second clamp 2, in a state in which the first clamp 3 has moved in parallel with the second clamp 2. JP7080058 (A): The patent relates to a process for enabling separation to four components and to rapidly make the bag connector aseptic by providing the bag connector with a tube communicating at one end with the top end of a first bag and at the other end with a second bag, a tube communicating at one end with the bottom end of the first bag and at the other end with a third bag and a tube communicating at one end with a fourth bag and at the other end with the first bag. This bag connector is quadruple bags formed by connecting a blood taking bag 10, a plasma bag 40, a red cell bag 30 and a small-sized bag 50 by the respectively prescribed tubes. The upper part of the bag body 11 of the plasma bag 10 is provided with a discharge port 15 for blood transfusion and a connecting member 17 for connection to the plasma bag 40.; The left side of the tube 40 in the upper tube 19 of the bag body 11 is provided with a connecting member 24 for connection to the red cell bag 30. One end of the tube 28 having flexibility is so connected to the center in the upper part of the bag body 50 of the small-sized bag 50 so as to communicate with a buffy coat housing part 53 and the other end of the tube 28 is connected to the branching end of a branching connector 26. US 7119305: The present invention has a purpose of providing a tube connecting apparatus capable of stably, accurately executing control of wafer temperature even when connecting of tubes is conducted continuously. A tube connecting apparatus (1) includes a heater (70) for heating a wafer holder (5a), a thermister (71) which detects the temperature of the wafer holder (5f), a heater heating control device (69) which controls the heater (70) based on output of the thermister (71), and a wafer heating control device (68) which performs heating control of a wafer (6) through constant power control. Before the start of heating the wafer (6) by the wafer heating control device (68), the control of the heater (70) is performed by the heater heating control device (69) for temperature control so that the wafer holder (5a) is heated to a fixed temperature (about 65° C). US 5802689: A tube connecting apparatus includes first and second tube holders holding flexible tubes, a cutting blade for heating, melting and cutting the tubes held by the holders between the holders, and a holder displacing mechanism for relatively displacing the second holder to the first holder to closely contact and connect cutting ends of the tubes each other. Each of the first and second tube holders has a tube holding portion which holds the tubes in a state that the circular cylindrical surfaces of the tubes which are contacting each other. EP 0571978 (AD: A heater element, suitable for use in a tube connecting device, comprises a metal plate, an insulation layer formed on one surface of the metal plate, a resistor formed on the insulation layer for electrically generating heat, and terminals respectively connected to both ends of the resistor. The resistor is produced by a screen printing process by which a desired pattern of a conductive paste is printed and hardened. In the patent No. 4507119 , the tube connecting device comprises a set of holders or blocks capable of holding parallel a pair of tubes to be connected with each other and a wafer or a heater element movably disposed between the blocks so that it can transversely cross the tubes. The wafer is heated while the two tubes are held by the blocks in parallel and in opposing direction with each other. The heated wafer is moved to melt and cut the tubes. Then one of the holders is moved relative to the other block in a direction perpendicular to the tube until the axis of the tubes meet together in a line and the wafer is removed. The melted ends of the tubes are fused together. In the cited European patent, predetermined voltage is applied on the heater element , suitable for use in the tube connecting device which comprises of metal plate separated in to two halves along a fold line, an insulation layer formed on one surface of the said metal plate, a resistor formed on said insulation layer for electrically generating heat; said resistor comprising a solidified conductive paste applied in the winding pattern on said insulation layer, said resistor having first and second ends, said conductive paste including a binder , a pair of terminals respectively connected to both ends of the said resistor; and means for applying a voltage across the said pair of terminals to cause an electrical current to flow through said winding pattern of conductive paste for causing said resistor to generate heat, characterized in that the resistance of said resistor is variable by denaturation of said binder under electrical heating of the resistor itself. In the present invention low cost materials easily available in the open market such as Nichrome wire and mica are used for making the heating element for achieving the similar results, there by making the running cost of the heating element very economical. Since the heating element is for single use only, the cost per unit of weld is very much reduced which will enable more number of the blood banks to use the system to provide safe blood or its components for transfusion. The cited European patent has following drawbacks. In this case, when the electrically heated wafer comes in touch with the tubes, the tubes get melted and the melt gets retained on the wafer metal surface. On further heating, the molten material gets over heated and the process of welding is such that this over heated material on the metal surface of the wafer gets dragged on to the weld. These retained left over material on the metal surface when dragged on to the weld during the procedure, will result yellowishness which is as a result of decomposition of PVC due to the over heating. The other drawback is that when the wafer moves down wards, the yellowish plastic molten material retained on the metal surface comes in contact with the cut ends of tubes and is carried over on to the top of the weld resulting in the non uniformity of the welding. Another drawback is that the quantity of the melt at the top of the tubing will also be different than at the bottom due to the carry over of the dragged material. Hence the weld over the periphery of the tubing will not be uniform. The other drawback of the cited patents are that by moving one of the holders towards the wafer, centrality of the wafer on the weld is lost resulting in to the further non uniformity of the weld. The tube held in holder which moves towards the heater element making the cut face end melt more because of further pressing movement towards the heating element. Where as there is a negligible melt on the other tube side cut face as there is no movement of other tube by its stationery holder. There fore melt for the weld is being mainly obtained from one cut face of tubing. This therefore results in further non uniformity of weld. The object of the present invention is to overcome the above said drawbacks. Another object of the present invention is to produce more economical heating element using commonly available market materials which are low cost and using a process which is far simpler than the one used in the prior art. Yet another object of the present invention is to reduce the manufacturing time and reduce the manufacturing cost of the heating element. The other object of the present invention is to provide a contamination free sterile tube connecting system using low cost heating element and simple process. The other object of the present invention is to provide more uniformity in the welding joint. Yet another object of the present invention is to provide a heating element and a process which will assure an effective weld of the melted tube section. Yet another object of the present invention is to provide a process which increases the resulting weld strength of the weld tubes. Summary of the invention The present invention provides a process for making aseptic fusion of two interconnectable tubes made from same thermoplastic material using a low cost heater element capable of moving upwards and downwards and two holders, such that each holder have capacity to hold plurality of tubes separately and horizontally; grooves are aligned on a straight line at the same level as to each other in a horizontal direction; a heating element is placed in between the holders which on heating by the electrical circuit, melts and cuts the tubes held by the holders, at the desired position; and moving means are provided which move both the holders horizontally and differentially with a different quantum of travel . for the alignment of the tubes, so that a new unused area of the heating element will come in touch with the tube's cut portion; and a mean for moving the holders towards the heater element with same speed and travel, maintaining the centrality of the heating element, providing equal melt quantity from each tube cut face such that a uniform welding of the cut ends of the tubes held by the holders takes place on down ward movement of the heating element. The present invention provides a process for making aseptic fusion of two tubes of same thermoplastic material. The heating element in the apparatus includes an electrical resistor for generating heat when connected in circuit with power supply. This acts as a cutter by melting the tubes and there after on alignment of the tubes, connecting the tubes by heating and fusing the cut faces, while maintaining the sterilized condition. The tube connecting apparatus comprises of two holders to hold the tubes to be connected horizontally and a heating element is held in between these holders in a channel so that the heater element can move up and down. The heating element is capable of moving in direction of Z axis as indicated in figure L. The tube holders are capable of moving in a direction of X axis as well as Y axis as shown in the figure L. After holding the tubes horizontally and in opposing directions, the heating element R is heated electrically and moves upwards so that it can cut the tubes by melting. Then both the holders are moved differentially in horizontal direction with a different quantum of travel until the axis of the main two tubes to be weld are aligned and the cut faces move to the unused area of heating element. The heater element is now moved down while the two holders move towards the heating element and the new unused surface of the heating element will come in contact with the tube's cut melted face, pressing against the heater element. The movement of holders is done by maintaining the heating element centrality and ensuring equal travel of tubes towards the heating element surface. In this process the molten faces of the tubing to be joined get pressed against each other as the element moves out, and get fused together. Since the face of both of the tubing are either pressing against the heating element surface or against face of the other tubing which is fused and get welded together in the process, and are not at all exposed to ambient environment, a sterile connection is thus established, presuming that the inside of both the tubes are sterile. The tube holder displacing means are provided to move both the holders horizontally and differentially with a different quantum of travel on the heating element surface, so that the alignment of the cut ends of the tubes will be aligned coaxial and a new unused area of the heating element that come in contact with the cut ends of the tubes. On electrically heating the heating element and due to its upward movement, the tubes get melted and melt gets retained on the heating element metal surface. The cut ends of the tubes are moved to a new unused surface of the heating element so that molten material which gets overheated and tends to become yellowish, because of the decomposition of PVC due to over heating will not be dragged on to the weld. This results in the better uniformity of the welding. When the heater element moves downwards, the yellowish overheated molten material will not be dragged as it does not come in contact with the cut ends of the tubes, thereby an effective welding of two tubes will take place with fresh melted material. In addition, as the melt material at the entire cut surface of the two tubing is fresh, no nonuniformity of material during the weld is observed. As both the holders are moved towards the heater element with same speed and travel keeping centrality of the heater element, both the cut ends of the tubes will melt uniformly providing equal quantity of fresh melt from each cut face of the tube there by resulting in to the effective uniform welding of the tubing. The heating element is made from low cost commonly available economical material and the process to make the heating element is extremely simple, resulting in to low cost of heating element. The low cost of the heating element, which is being used one time only by the blood banks, will result in low running cost enabling more number of blood banks to use the technology to provide safe blood/ its components to the user. Brief description of the invention with drawings: Figure A shows the insulation sheet 1 with two holes P1 and P2 punched in it. Figure B shows the second insulation which is smaller than the sheets 1 and 3. Figure C shows the third insulation sheet with no holes. Figure D shows the insulation sheet 2 wound with metal wire. Figure E shows the metal foil. Figure F shows the perspective view illustrating the steps for making heater element. Figure G shows the sandwiched insulated sheets. Figure H shows the opened metal sheet with two holes P3 and P4. Figure I shows the heating assembly. Figure J shows the back view of copper plate sandwiched with insulator. Figure K shows the front view of the heating element R. Figure L shows the perspective view of the holders. H1 is the first holder and H2 is the second holder. Tg1 and Tg3 are the grooves for holding the tube S1 and Tg2 and Tg4 are the grooves for holding the tube S2. V is the lock of the holders. Figure M shows the perspective view of the connecting tubes S1 and S2 to one another using the tube connecting device. Figure N shows the movement of the heater element upward and cutting of the tubes. Figure O shows the movement of the holders to align the tubes. Figure P shows the movement of the heater element downwards and also the movement of the holders towards the heater element. Detailed description. The heating element acts as a cutting blade heated at a high temperature for melting and cutting the plurality of tubes. It is a heat generating system connected to the electric circuit and is structured by a folded copper plate sandwiching an electric resistance by an insulating material. The electric resistance is connected to an electric power source. The heating element is made from a thin sheet of heat conductive metal material such as copper folded in such a way so as to hold the resistor with insulating material in between its fold. Copper is used as the sheet material of the heating element because of having high thermal conductivity to allow heat to be uniformly distributed along the surface of the material. The heating element includes an electrical resistor for producing heat when connected in circuit with power supply. The heater element is mainly made of three thin sheets of mica which is an electrical insulator, Nichrome wire and thin metal heat conductor sheet like copper. All the mica sheets are less than ten micron thickness. Mica sheet 1 as shown in the figure A has two holes P1 and P2 punched in it. Mica sheet 3 as shown in the figure C has same thickness and size as that of the mica sheet 1 but there are no holes punched in it. Mica sheet 2 as shown in the figure B is smaller than the size of the mica sheet 1 and mica sheet 3. A thin NICHROME wire is used to provide resistance for heating by passing a specified current at a known voltage. The resistance of the Nichrome wire used is 80 Ohms to 200 Ohms. The Direct current voltage used varies from 12 V to 70 V. The voltage used and the resistance of the Nichrome wire used is so designed that the metal surfaces of the heating element achieve a temperature of 275°C to 300 °C in 2- 3 seconds. The Nichrome wire is wound on the mica sheet 2 with both the terminal ends T1 and T2 kept on the same sides and in locations which is in concentric with the two punch holes provided in the mica sheet 1. Two metal foils (Figure E) are round cut in the diameter which is greater than the diameter of P1 and P2. The assembly I is done as shown in the Figure F. The mica sheet 1 is placed on bottom. The two punch holes P1 and P2 are now covered by concentrically placing one piece each of metal foil shown in figure E. The coiled Mica sheet as shown in Figure D is now placed on it in a manner so that the terminals T1 and T2 of the coiled Nichrome wire are placed on to the center of metal foil covered by punch holes P1 and P2. The mica sheet 3 shown in the figure C is now placed over and above the coiled mica sheet. It is ensured that the Nichrome wire is fully covered by mica sheet 1 from one side and mica sheet 3 from other side. There should not be any exposed Nichrome wire outside the mica sheets. This assembly I, as shown in figure G is ready for further use. A copper metal sheet of 10 micron thickness or less is taken and is blanked in the shape as shown in the figure H using a suitable die and punch system. Two punch holes P3 and P4 are provided at center distance which is same as that of P1 and P2. The diameter of P3 and P4 are 2mm bigger than that of P1 and P2. The copper metal sheet as shown in the figure H is now bent on axis a-a' so that the side 'c d ' is not touching side 'd e'. The assembly I is now placed on one side of the above bent sheet in a manner so that the punch holes P1 and P2 lie concentrically on punch holes P3 and P4. Holding the assembly I, the copper metal sheet is now fully bent so that the side 'b c' lies above and fully touches the side 'e d'. The metal surface is now kept fully pressed and the folder F1 and F2 and F3 are folded and fully pressed over the three sides , with full grip as shown in the figure J. A corner 'g h' is cut off from the assembly as shown in the figure K, keeping the precaution that it does not cut the Nichrome wire. This heating element is used in the sterile tube welding equipment. The device for forming a sterile connection between two thermoplastic tubes S1 and S2 contain two holders H1 and H2 each of which holds a plurality of tubes having flexibility. Grooves Tg1, Tg2 , Tg3 and Tg4 are provided in the holders and the grooves are aligned on straight line axis so that these can hold the tubes in straight line. The tubes are placed in the grooves in such a direction that the first tube is in opposite direction to the other which is shown in figure M. Each of the tube holders has a tube holding portion (grooves) which holds plurality of the tubes in a state that the circular cylindrical surfaces of the tubes are firmly held in the groove. The holders are so arranged that the grooves are aligned on a straight line axis at the same level to each other horizontally. Figure 'U is the perspective view of the holders H1 and H2. Figure M illustrates the steps for connecting tubes S1 and S2 to one another using a heater element. The tube connecting device comprises of two holders H1 and H2 and a heater element R. A pair of grooves Tg1, Tg2 , Tg3 and Tg4 are provided in the holder for holding the tubes S1 and S2. A lock 'V is provided in each of the holders for pressing and locking the tubes when the holders are closed. As shown in figure M, the tubes S1 and S2 are horizontally placed in such a manner that the closed ends of the tubes are directing opposite to each other. Then the holders are closed and locked. A voltage of 12 V to 70 V is applied across the terminals T1 and T2 by the controller so that the resistor of the heater element generates heat and heater element is heated to a temperature 275°C to 300°C in 2-3 seconds. Then the heater element will move upwards in the direction of Z - axis, thereby melting and cutting the tubes as shown in the figure N. As the temperature of the heater element is very high and the melted cut face ends of the tubes are not in contact with the outside, so a sterilized state is maintained there. Then as shown in the figure 'O', the holders H1 and H2 are moved in a direction of Y axis as indicated by the arrow. The holders H1 and H2 are moved differentially with a different quantum of movement so that the new unused surface of the heater element comes in contact with the cut ends of the tubes while the alignment of the tubes to be weld takes place. Then the heater element is pulled down in the direction of minus Z axis while both the holders are moved on X- axis towards the heater element pressing the melt face of the tube held by it and providing more melt for welding. The face of the two tubes fuses together to make the weld as the heating element moves out enabling more and more cross section or face of the tube to come together and fuse for welding as shown in figure P. The centrality of the heating element is fully maintained as both the tube holders H1 and H2 move with the same speed ensuring equal travel and displacement towards the heating element. This provides equal quantity of fresh molten material from both cut faces of the tubes for uniformity of the weld. An electro mechanical device system is used to provide and control the above requirement of mechanical movement. A suitable electronic control circuit is used to provide the voltage and current to the heating element and maintaining the temperature of the heating element for the period required, once it is heated to the required temperature. As a result of this, equal melt quantity from both the tube faces is produced and a uniform weld is achieved. Since both the cut ends of the tubes are at a high temperature, in a molten state and also are in contact with the heater element and are not at all exposed to ambient conditions, the sterility of the tubes is perfectly maintained. I Claim: 1. A process for making asceptic fusion of two interconnectable tubes made from same thermoplastic material using a low cost heater element capable of moving upwards and downwards and two holders, such that each holder have capacity to hold plurality of tubes separately and horizontally; grooves are aligned on a straight line at the same level as to each other in a horizontal direction; a heating element is placed in between the holders which on heating by the electrical circuit, melts and cuts the tubes held by the holders, at the desired position; and moving means are provided which move both the holders horizontally and differentially with a different quantum of travel for the alignment of the tubes, so that a new unused area of the heating element will come in touch with the tube's cut portion; and a mean for moving the holders towards the heater element with same speed and travel, maintaining the centrality of the heating element, providing equal melt quantity from each tube cut face such that a uniform welding of the cut ends of the tubes held by the holders takes place on down ward movement of the heating element. 2. A process as claimed in claim 1 wherein the heater element placed in between the holders comprises of: three insulator and conductor plates such that two insulating sheets are of same size and one is smaller than the other; first sheet is punched with two holes on opposite ends; second sheet is wound with Nichrome metal wire to form a resistor which is sandwiched between other two insulating sheets; a metal foil is provided in between the first sheet and the insulated resistor at the position corresponding to holes; the insulated resistor is placed in between the folded metal sheet concentrically with the holes in the metal plate; for providing a pair of terminals on both the ends for applying voltage across the terminals. 3. A process as claimed in claims 1 and 2 wherein the heater element is having a thickness less than 1mm. 4. A process as claimed in claims 1 and 2 wherein the tube holder displacing means are provided to move both the holders horizontally and differentially with a different quantum of travel on the heating element surface, so that the cut end of the tubes will be aligned coaxial, and a new unused area of the heating element will come in touch with the cut end of the tubes. 5. A process as claimed in claims 1 and 2 wherein on movement of the holders horizontally, the cut ends of the tubes are moved to unused area of the heater element so that the left over overheated yellowish molten material on the heater element will not be dragged on to the weld which results in the uniformity of the welding. 6. A process as claimed in claim 1 and 2 wherein on downward movement of the heater element, the yellowish overheated molten material will not be dragged and it does not come in contact with the cut ends of the tubes so that an effective welding will take place with fresh melted material at the cut ends of the tubes. 7. A process as claimed in claims 1 and 2 wherein on downward movement of the heating element, the cut faces of both the tubes are being pressed against the surface of the heating element, by suitable movement of the holders towards the heating element and maintaining its centrality, and equal quantum of tube melt is provided by both the cut faces of the tubing and providing enough material for fusion to give absolute uniform weld of the tubes. 9. A process of asceptic fusion of two interconnectable tubes using a low cost heater element as here in substantially described with reference to and as illustrated in accompanying drawing.

Documents:

543-DEL-2009-Abstract-(26-06-2009).pdf

543-del-2009-abstract.pdf

543-DEL-2009-Claims-(26-06-2009).pdf

543-del-2009-claims.pdf

543-del-2009-Correspondence Others-(09-10-2014).pdf

543-DEL-2009-Correspondence-Others-(26-06-2009).pdf

543-del-2009-correspondence-others.pdf

543-del-2009-Description (Complete)-(09-10-2014).pdf

543-DEL-2009-Description (Complete)-(26-06-2009).pdf

543-del-2009-description (complete).pdf

543-del-2009-Drawings-(09-10-2014).pdf

543-DEL-2009-Drawings-(26-06-2009).pdf

543-del-2009-drawings.pdf

543-del-2009-form-1.pdf

543-del-2009-Form-13-(09-10-2014).pdf

543-DEL-2009-Form-18.pdf

543-del-2009-Form-2-(09-10-2014).pdf

543-DEL-2009-Form-2-(26-06-2009).pdf

543-del-2009-form-2.pdf

543-del-2009-form-3.pdf

543-del-2009-form-5.pdf

543-DEL-2009-Form-9-(23-03-2009).pdf