Device for Aseptically .Connecting Tubing
CROSS REFERENCE TO RELATED APPLICATIONS
This application claims the benefit of US provisional application number 63/525.070 filed July 5. 2023, which application is incorporated by reference in its entirety herein.
FIELD OF THEJNVENTIQN
The field of the invention are devices that can be used to aseptically join two devices (such as tubing connectors), or replace one device of a joined pair with another device, wherein the function of the devices is to transfer fluid from one device to another in an aseptic manner.
BACKGROUND OF THE INVENTION
In the handling biological or other materials there is frequently the need for sterility including during such vulnerable operations as joining tubes whose function is allow fluid flow. Any contamination that enters the fluid stream may severely compromise the operation, causing extensive lose of time, effort and money. In such cases, it is crucial that, any connection or disconnection in the flow path occur without introduction of a foreign contaminant.
Methods for achieving sterile joining of tubing are common and well understood: For example, one technique involves steam or running steam through a formed connection to decontaminate the connection, In the case of steam, however, the components to be sterilized must be constructed from materials that are compatible with steam temperatures and pressures, commonly, 121° C and 18 PSI. The use of steam as a sterilizing agent also has other requirements such as a steam generator, safety measures to protect operating personnel, and process design so mat me fluid re the tubing will not be damaged. The use of steam, nevertheless, is common in “targe facilities" where the design of the facility allows for steam sterilization. In general, “smaller" facilities will not adapt steam as a sterilization agent because of the high capital cost, fixed nature, or inflexible nature of the steaming system. When possible, they may avoid the need for steam sterilization by using pre-sterilized “single use” components.
Alternatives to steam include the use of presterilized components, chemical sterilization, welding, heat fusion or using a sterile environment to perform all aseptic operations.
Many vendors provide sterile single-use (SU) sterile connectors. Such SU connectors are typically designed to connect tubing with an inner diameter (ID) in the range between 0,125 and 1.5 inches. As the name implies. SU connectors are typically used once only and then discarded, Frequently, however, their connection needs to be severed and reformed with another tubing connector or other device. There is such a capability when steam is available , where the steam may be directed to the reconnection to sterilize that connection. Another method involves tube welders, where a set of thermoplastic tubings are cut simultaneously with a “hot knife”, in which case the knife also melts each of the thermoplastic tubings at their cut point. The selected ends of each set of tubing are aligned and merged to reform the flow path upon coding; the method, however, is not without flaws. The reformed connection is frequently distorted or even plugged if the "fluidized" thermoplastic does not set precisely; furthermore this process is fixed to a specific tubing diameter, requiring the purchase of a specific “welder for each tubing size
Current methods ter making sterile connections between adjacent segments of tubing are best suited for tubing with an inner diameter (“ID”) in the range between 0.125 Inches and 1.25 inches. U.S. patents of interest include, but are not necessarily limited to, numbers 6,679,529; 6,880.801; 8,656,655; 7,676,096; 8,491 ,016, 8,899,267 and 9,027,968.
There am a number of prior art "shielded connectors” that are equipped with a removable shield that blocks the central opening of a connector tube. That shield remains attached until the connector is ready to be joined to another, similar connector. The shields remains between the joined connectors until the flow path between the connectors requires opening; in which case, the shields are removed. The connectors remain interlocked until the end of the process. Such a connection, while highly effective in forming a single aseptic connection, is not suitable for repeated engagement and disengagement . Connectors of the present invention are designed to overcome such a shortcoming. The current invention addresses the need not only to form aseptic connections between tubing at any scale (including “small bore tubings'") but also how to make such aseptic connections repeatable; that is, how to severe and remake a connection in a sterile manner. A connection is formed between two connectors, each normally with tubing attached. The inventive concepts are, however, applicable to devices other connectors.
The present inventions allow connector or tubing assemblies to be aseptically disconnected (separated from another connector without introduction of a contaminant into the fluid contents of the connector). Also they allow a third sterile connector or other device to replace one connector of a pair without introduction of a contaminant, That process may be repeated multiple times.
Built upon a prior art of shieldable flanged connector design , the current invention provides features and modifications that greatly extend the capabilities of the shielded connector. In the simplest form, a tube is attached at one end, the distal end, of said connector through, preferably, a barb adapter or other forms of tubing connecting devices. The tubing ID is fitted or “slipped over" the the barb adapter of the connector. The connector having a channel that extends ths axial length of the connector, emanating at the canter of the other, proximal end, of the connector. A continuous conduit is thus formed through the tubing connector assembly. The proximal end of the connector consists of a Hanged with mostly a fiat surface end; from which center, the conduit of th® tube connector assembly emanates. A concentric “O” ring or gasket groove is formed at the center of the connector proximal face. An "O” ring or gasket is seated within that groove, slightly elevated above the proximal face of the connector. The axial channel through the V connector remains continuous with the attaches tubing of the tubing assembly and the “O” ring/gasket at the proximal face. The proximal flange face and *O:! ring of the connector are shielded with covering of a flexible membrane. The membrane is secured to the face of the connector preferably by bonding, preferably with heat but which may also be accomplished with adhesives or some other means. The shield is preferably a flexible and microporous material that is compatible with a preferred method of sterilization, e.g., Heat, steam, gamma radiation, ETC, etc. Two connectors, with their respective shields folded upon themselves and aligned, am merged and locked against each other with a clamp. The folded and aligned shields may be than extracted from between the Connectors, -allowing the uncovered “O” rings to seat against each other: thereby, the “O” rings form a leak-proof barrier between the connectors with a conduit through the IDs of the “O” rings.
Once the above connection is made and secured, typically, it must remain secure until the process is completed. That connection cannot be broken and reformed in the open because a disconnection between the connectors and exposure of the flow path risks contamination, it would be useful therefore if such breaking and remaking a sterile connection can be accomplished in the open reliably without introduction of a contaminant. It would be oven more desirable if such making and breaking a sanitary connection can be accomplished multiple times while maintaining the sterility of the flow path, The current invention addresses this problem in two ways: First, by developing a uniquely designed connector that is amenable for making a single aseptic connection and also allows ths connector to be protected during subsequent disconnections and connections; secndly, by describing an associated device that uses the features in the connectors to join or disconnect said connectors multiple times in an aseptic manner.
BRIEF DESCRIPTION OF THE DRAWINGS
Fig. 1A Multiple views of a connector device suitable for use with the clamps of the invention.
Fig. 1 B Additional views of the connector device of Fig , 1 A, Fig. 10 Additional views of the connector device of Fig. 1A. Fig, 2 Multiple views of a shielded connector device suitable for use with the clamps of the invention.
Fig . 3A. Two views of a B-olamp.
Fig. 3B Additional views of the B-clamp of Fig. 3A, Fsg, 3C Additional view of the B-clamp of Fig. 3A.
Fig, 4, Perspective view and partial sectional view of an A-clamp, The section line A - - A only refers to the section denoted by 55 in the Figure. The cutaway view of the partial sectional view allows the spring 59 to be seen and, underneath it, a surface marked by parallel hash lines to help distinguish it from its surroundings. Fig. 5A Views of an A-clamp interacting with two shielded connector devices.
Fig, 5B Views of an A-clamp interacting with two shielded connector devices.
Fig SC Views of an A-clamp and a 8-clamp interacting with two connector devices. The three views schematically illustrating, sequentially top to bottom, the use of a B-clamp to stabilize the connection between two connector devices held by an A- Ciamp and then removal of the connected devices from the A-clamp.
Fig. 5D Views of a B-clamp interacting with two connector devices
Fig. 6. Perspective view of a C-clamp and a perspective views of a C-Clamp interacting with a two shielded connector devices.
Figs 8A-6B 'Two views of a C-clamp interacting with a two shielded connector devices. Fig. 6C Views of a C-clamp interacting with the two shielded connector devices of Figs, 6A and 68 after their shielded connectors have been removed.
Figs. 6D-6F Three views of a B-clamp and two connector devices.
Fig. 7, View of a B-clamp grasping portions ot two connector devices end a view of a C-Clamp in a pistol-like configuration and holding a heating wedge. Figs. 7A~7c Views of a C-clamp with its heating wedge in a position to accomplish sterilization of surfaces. Fig. 8. Multiple views of the components of a heating wedge
Fig. 9. Views of a C-clamp with a heating wedge disposed between two connector devices.
Figs. 10A-C Sectional views of part of a C-clamp with its jaws in a closed position and two open positions.
Fig. 10.1 View of the C-clamp of Fig. 10C where the broken line B • B shows the plane from which the sectional view in Fig. 10C is taken.
Fig. 11. View of a C-cog in a C-clamp.
Fig. 11.1 View of the C-cog of Fig. 10A where the broken line B - - 8 shows the plane from which the view in Fig. IDA is taken.
Fig. 12. Perspective view and sectional view of a C-ciamp.
Fig. 12.1 View of the Clamp of Fig. 12 showing the plane from which the view in sectional view in Fig. 12 is taken.
Fig . 13. Two partial sectional views of part of a C-clamp showing the rail bar in compressed and extended positions.
Fig 13A Partial sectional view of the C-clamp of Fig. 12.
Fig. 14. Two sectional views of a C-clamp shown in Fig, 12. With the trigger at two different positions.
Fig. 14.1 View of a C-ciamp of Fig, 14 showing the plane from which the sectional views in Fig. 14 are taken.
Fig. 16 Perspective views of two connector devices in which the lumen has a ¥- shaped configuration.
Fig. 18 Three views schematically illustrating, sequentially top to bottom. the use of a B-clamp to stabilize the connection between two connector devices held by a C-Clamp and then stabilize the removal of the connected devices from the C-ciamp. Fig. 17 Two views schematically illustrating, sequentially top to bottom, the use of an A-Clamp join two connector devices in the case where each device has a forward surface opening that leads to a lumen that splits into three directions.
BRIEF SUMMARY OF THE INVENTION
The invention in a general aspect is a clamp that can grasp a pair of devices, especially tube connectors, each device comprising a lumen that allows fluid flow, such that the devices can be either separated or tightly joined with their lumen entrances or exits aligned so that the pair is impervious to infection via the lumen entrances. The clamp can facilitate operations such as the joining of the two devices, or the replacement of one of the devices by another One example or interest is a clamp wherein a heat-emitting fiat sterilizing shield can be reversibly inserted between joined devices, minimizing the need for a sterile environment during the replacement of one device by another device.
A closely related invention is a tube connector comprising a flange at one connector end - its proximal end ~ and on the connector’s surface, a proximally located groove and a distally located groove. As a result, a clamp can engage the proximal grooves of two identical connectors simultaneously and a clamp can engage the distal grooves of the two connectors simultaneously. Such grasping of the proximal grooves and the distal grooves optionally can occur simultaneously.
DETAILED DESCRIPTION
Aspects of the invention
(This list mirrors the Claims.)
Aspect 1. A tube connector comprising two grooves on its exterior surface, wherein the connector comprises a proximal end and a distal end. and wherein the two grooves are a proximal groove and a distal groove such that os to the two grooves, the proximal groove is doser to the proximal end of the connector, wherein there is a flange at the proximal end of the connector, and wherein the connector comprises an internal lumen that permits fluid flow entering one of the two connector ends to exit at the other connector end, such that the lumen extends through the flange.
Aspect 2. A tube connector of Aspect 1 said connector at its proximal groove being in the grasp of a set of jaws of a clamp, the set comprising an upper and lower jaw each of which are part of one side of ths clamp, the connector further comprising opposite to said side an identical second side such that the set of jaws of the second side can simultaneously grasp the proximal groove of a second connector of Claim 1 thereby compressing the two connectors together, said clamp referred to herein as a B~clamp,
Aspect 3, A ciamp tube connector Aspect 1 wherein the distal groove is clamped by a jaw of a clamp, said damp referred to here as an A-clamp, said A-clamp comprising two jaws which allow said A damp to simultaneously grasp the distal groove of of two connectors of Claim 1.
Aspect 4. A tube connector Aspect 1 wherein the distal groove is damped by a jaw of a clamp, said damp referred to here as a C-clamp, said C-clamp comprising two jaws which allow said C-clamp to simultaneously grasp the distal groove of two connectors of Claim 1, said C-Ciamp further comprising a heating element that can be reversibly placed between the flanges of the two connectors
Aspect 5. A tube connector of Aspect 3 such that each jaw of the A-clamp is connected to a handle, and movement of the handles will affect the distance between the jaws.
Aspect 6 A tube connector of Aspect 4 such that each jaw of the C-clamp is connected to a handle, and movement of the handles will affect the distance between the jaws.
Aspect 7. A tube connector of Aspect 5 wherein the A-Clamp further comprises a pivot pin, wherein both handles fit on the pivot pin and altering the distance between the handies alters the distance between the jaws.
Aspect 8. A clamp (referred to here as an A-clamp) comprising two jaws, a first jaw and a second jaw, each jaw comprising a frame and an adjunct attached to the frame, the frame being capable of grasping a device because part of the device will fit into the frame, wherein the adjunct of the first jaw comprises a pivot hole but no pivot pin , wherein the adjunct of the second jaw comprises either a pivot hole or a pivot pin that is fittable in the pivot hole of the adjunct of the first jaw, wherein, if neither adjunct comprises a pivot pin, then the A-clamp comprises a pivot pin at a place other than on one of its jaws, said pivot pin flttable simultaneously in both jaw pivot holes, wherein the separation distance between the jaw frames is adjustable by rotation of at least one jaw about a pivot pin, and wherein when the devices are sufficiently close to each other to permit joining them to each otheu the devices are aligned as regards their entrances and/or exits for fluid flow from one device to the other
Aspect 9. An A-clamp of Aspect 8 wherein each of the two jaw adjuncts comprise an arm that can be interlocked with the arm of the other adjunct.
Aspect 10. An A-ciamp of Aspect 9 wherein the A-clamp further comprises a torsion spring that provides a counter force to the manual closing of the clamp.
Aspect 11. A clamp (referred to here as a C-clamp) comprising two jaws st its proximal end, each jaw comprising a frame and an adjunct attached to the tram®, the frame being capable of grasping a device because part of the device will fit into the frame, the adjunct of each jaw comprising a pivot hole, the C-clamp comprising one pivot pin for each pivot hole, wherein each frame can grasp a device so that a forward surface of each device will be directly joined to the forward surface of the other device when the devices are joined, and openings at the forward surfaces of the two devices will be aligned so as to aiiow flowed transfer between the devices, and wherein a compressible (elastic) gasket comprised by a forward surface is considered to be part of the surface where said gasket protrudes from the forward surface. Aspect 12 A C-ciamp of Aspect 11 „ wherein each frame and adjunct are part of a cog, wherein the portion of the oog distal to both the pivot hole and the adjunct is a cam segment characterized by a curved edge and curved surface (preferably where the angle of the curve changes progressively along the edge).
Aspect 13. A c-clamp of Aspect 12, wherein rotation of the cog around the pivot pin can, depending on the direction of the rotation, determine whether the jaw frame will be moved closer to or farther from the other frame of the C-clamp.
Aspect 14. A C-clamp of Aspect 13 wherein rotation of the cog (and jaws) about the pivot pin is induced by the linear motion of a linear push bar, said push bar comprising a fir's! end and a second end. the first end comprising a head, said head in sliding contact with a curved edge of the cam.
Aspect 15. A C-clamp of Aspect 14 which clamp comprises there is a first spang and a second spring. wherein the first spring is a coled spring that is attached to the second end of the push bar, and wherein the second spring is a leaf spring that is in sliding contact with the edge of the cam segment and will be bent or straightened by rotation of the cog.
Aspect 16. A C-clarnp of any eno of the foregoing Aspect 11 -15, said clamp further comprising a sterilizing wedge that can be wedged between the forward surfaces of joined devices. Aspect 17. A C-ciamp of Aspect 16 wherein the sterilizing wedge comprises two fiat parallel wedge surfaces, said two wedge surfaces for making sealing contact with the forward surfaces of two joined devices. Aspect 18, A C-clamp of Aspect 17 wherein the two hat parallel wedge surfaces are for making sealing contact with the gaskets of the forward surfaces of the two joined devices.
Aspect 19. A C-clamp of Aspect 17 or 18 wherein the separation distance between a hat wedge surface and a portion of the device forward surface other than the gasket is not more the 0.1 mm.
Aspect 20. A C -clamp of Aspect 17 or 18 wherein the separation distance between a hat wedge surface and a portion of the device fowvard surface other than the gasket is in the range 0.1 mm to 2,0 mm.
Aspect 21. The C-clamp of any one of Aspects 16 through 19 wherein the sterilizing wedge has a property selected from the group consisting of (1) it can radiate heat, (2 ) it can radiate LiV light, and (3) it comprise hoiss through which a chemical can be sprayed.
Aspect 22. A C-clamp of any one of Aspects 16 through 21 wherein ths sterilizing wedge is connected to a rail bar such that linear motion of the rail bar can result in linear motion of the sterilizing wedge from esn initial position where it is not wedged between the forward surfaces of two joined devices to a sterilizing position where it is wedged between the forward surfaces of two joined devices. Aspect 23. A C-clamp of Aspect 22 which further comprises a rail bar groove within which linear motion of the rail bar can occur.
Aspect 24, A C-clamp of any one of Aspects 16 through 23, said C-lamp further comprising a trigger, said trigger comprising a trigger pivot hole and a trigger pivot pin for placement in the trigger psvot hole, said pivot pin inside the trigger pivot hole, such that pulling one end of the trigger causes it to rotate about the trigger pin, and wherein the trigger la mechanically linked to the rad bar. such that rotation of the trigger causes the rail bar to move in the rail bar groove.
Aspect 25. C-ciamp of any one of Aspects 16 through 24, said C-clamp further comprising: a ratchet notch in the push bar, said notch capable of being engaged by a pawl tooth; a pawl pivot pin at a fixed position in the C-clamp, a pawl, said pawl comprising a pawl tooth,, the pawl at a fixed position in the C- clamp, the pawl positioned so that its tooth can fait into and engage the ratchet notch when the push bar is moved to a paint where the tooth and notch are aligned, the pawl further comprising a pawl handle and a pivot hole located between its tooth and its handle, the pivot hole positioned so that it contains the pawl pivot pin, such that pushing down on the pawl handle will raise the pawl tooth and disengage it from the ratchet notch: a compression spring, said spring axially aligned wrth tne push bar, said spring atone of Its two ends connected to the end of the push bar that is not sn contact the cam segment, said push bar at the other of its two ends connected io the C-clamp body; such that the compression spring is compressed as the push bar moves In a direction away from the C~iaw; and such that disengagement of the pawl tooth from the ratchet notch results in the compression spring pushing the push bar back to its position when the jaws are closed; a torsion spring under the pawl handle, such that the ratchet and pawl remain securely engaged by the action of the torsion spring (112), which forces those two parts together and engaged without slippage.
Aspect 26. A C-clamp of any one of Aspects 22 through 25, the C-clamp further comprising: a stop mechanism, such that when the rail bar has pushed the heating wedge to its desired position, the stop mehanism bar rotates about the pivot pin until one end of the horizontal upper segment of the T-shaped stop bar blocks the rail bar from moving in a direction away from the cog Aspect 27. A C-ciamp of any one of Aspects 22 through 26, the C-clamp further comprising: a stop bar and a stop bar pivot pin, said stop bar being T-shaped, with the T comprising a horizontal upper segment and a vertical lower segment that intersects the horizontal upper segment, and a pivot hole in the lower segment, the pivot hole centered in the pivot pin, such that when the rail bar has pushed the heating wedge to its desired position, the stop bar rotates about the pivot pin until one end of the horizontal upper segment of the T-shaped stop bar blocks the rail bar from moving in a direction away from the cog.
Aspect 28. A clamp (a/k/a 8-olamp) that comprises: two parallel major sides (each side preferably of square or rectangular shape), the two sides separated from and parallel to each other, each major side comprising a cut-out with an opening that extends to an edge of the major side, the opening of the cutouts being opposite to each other and expandable to allow a groove of each of two circular devices to either be pushed simultaneously into the two cutouts or pulled simultaneously from the two cutouts and out of the channels via their entrances.
Aspect 29. A laminated heating wedge, comprising a heating element disposed between two strips of metal (a/k/a leafs).
Aspect 30. A laminated heating wedge of Aspect 29 said wedge comprising a heating ribbon is overlaid with thin “metal” sheets (a/k/a leafs, shims, strips or plates), whose dimensions are similar to that of the heating ribbon, said wedge capable of generating temperatures as high as 120cC.
Aspect 31. A device comprising: a region that can be grasped by the jaw frame of an A-clamp or the jaw frame of a C -clamp or can be fitted into the cutouts in the two major sides of a B-clamp, said device comprising, in the proximal to distal direction, a flange, a first groove, a jaw frame-fitting wall (preferably with a square shape), a second groove and a back wall, said device further comprising a lumen and an elastic gasket, wherein the flange comprises a forward surface, wherein that surface is on the proximal side of the flange, wherein the forward surface comprises a groove for holding the gasket, wherein the gasket partially protrudes from said forward surface of the flange, wherein the lumen extends from the gasket into the device, such that the groove closest to the flange can be grasped by the B-clamp. and the groove farthest from the flange can be grasped by an .A-c-lamp or a C-clamp.
Aspect 32. A device of Aspect 33 wherein the lumen exits at one or more taxations on the device.
Aspect 33. A devsce of Aspect 32, referred to as a first device wherein the lumen composes a sensor that can be pushed (manually or automatically) from that lumen through to ths lurnen of a connected secund device and optionally out the other end of that connected second device into a chamber of that connected second device and subsequently can be pulled back into the lumen of the first device.
Aspect 34. A device of Aspect 33 wherein ths pushing or pulling is accomplished by a bellows mechanism attached to the first device.
Aspect 35, A device of Aspect 33, wherein the lumen extends from a location on the device forward surface to a bidirectional pump. said pump capable of forcing fluid from inside the pump to the lumen, said pump capable of withdrawing fluid from the lumen into the pump.
Aspect 36. A device of Aspect 36 wherein the bidirectional pump comprises a valve, such that flow in or out of the pump requires that the valve be in its open position. Aspect 37. A device of any one of Aspects 31 through 36 wherein the pump comprises a probe sensor that can sense lumen-derived fluid in the pump and measure a property of the fluid.
Aspect 38. A device of Aspect 37 wherein the property of the fluid is selected from the group consisting of pH, dissolved oxygen and temperature.
Aspect 39. A device of any one of Aspects 31-38, wherein the gasket and Hat surface of the flange of the device are covered by a shield (a/k/a tab) that can be pulled away from the device.
Aspect 40. A process wherein one or more clamps from the group consisting of an A-clamp, a B-clamp, and a C-clamp is utilized in a process intended to achieve one or more goals, said goals selected from the group consisting of (1) joining two devices and (2) replacing one of those two devices with a third device wherein each device is one through which fluid flow can occur.
Aspect 41. A process of Aspect 40 wherein the process Is earned out in a sterile environment.
Aspect 42, A connector assembly comprising a connector of Aspect 1 and two or more flow paths.
Aspect 43, A connector assembly of Aspect 42, said connector comprising three or more connectors of Claim 1 and two or more flow paths.
Aspect 44. A connector assembly of Aspect 42 comprising two or mere connectors of Claim 1 , wherein said connectors are grasped by the jaws of an A- clamp or C-clamp.
Aspect 45. A connector assembly of Aspect 42 comprising two or more connectors of Claim 1 , wherein said connectors are grasped by the jaws of an A- clamp. Aspect 48. A connector assembly of Aspect 44 wherein the connectors are also grasped by a B-clamp.
Aspect 47. A connector assembly of Aspect 4S wherein the connectors are also grasped by a B-clamp.
Overview, of the A-clamp, C-clamp, B-clarnp and a connector
Connector -The connector is a device configured for making aseptic connections with other similar devices according to the invention. The aspects of the connector that makes it functional are summarized: The connector contains a ’coupling proximal end*, which preferably is a rectangular flange in which the most proximal face is used to join a to second connector's proximal face. The connector also contains an "adapter at the distal end, which provides an attachment end for tubing or other devices that require aseptic coupling; for example, the distal end adapter is typically hose barb for when tubing is attached: however, the connector distal adapter may also be an adapter for placement of a probe or another device or it may be a second connector to form a union between connectors of similar or different sizes
The connector’s distal end adapter will frequently be a hose barb for attaching tubing. The hose barb can be designed to create a single exit to the connector's lumenr or multiple exits as when the lumen branches into a ¥~shape or T -shape. A branched arrangement may result in a manifold for attachment of a connector to multiple other devices. Variations of a hose barb adapter include, but are not limited to, a luer, compression, quick connects in their various forms.
As noted, the proximal coupling end of a connector comprises a flat flange surface, preferably a squars-like surface. A conduit extends the length of the connector, from its distal end io its proximal end. Along its length, the cormactor comprises a tumen through which fluid can How. In the most common case, where the connector is rigid, the lumen has a circular cross section of constant diameter throughout the lumen. In a linear connector, with a single distal end, an (imaginary) central axis of the lumen extends from one end of toe lumen (and connector) to the other.
In the flat flange proximal surface there is a groove in which a gasket (such as an Oring) can be retained -• albeit leaving part of the gasket or Oring protruding from the proximal flange surface. (The O-ring or other gasket ■■ if present is considered to be part of the connector). The portion of the gasket that protrudes will be capable of forming an air-tight seal with the protruding portion of a gasket of a similar or identical gasket of another device. Forces applied to the flanges of the connectors, in the direction of the other connector will force gasket against the other, thereby creating an airtight seal, if between the two gaskets (e.g., two Orings) , there ss a flat object or objects in parallel , an air tight seal can be formed as the gaskets are forced against such objects. The pressure forces needed can be generated by a variety of sources, including but not limited to the clamps that are the inventions described herein or are a part of those inventions. A “shield" (a/k/a “tab”) can be layered on top of the proximal flange, covering essentially the entire proximal face of the flange, including the proximal opening of the axial conduit and its surrounding “CT ring The shield is securely attached to the flange surface beyond the periphery of the “O” ring groove, forming a gap free protective covering to the proximal face. The peripheral portion or sides of the connector contains two “concentric" grooves, preferably “circular” grooves but alternately, where one or more sides may be straight, square or semicircular. One groove (referred to as “groove 1" or the “proximal groove" ) is located closer to the proximal face of the connector: the second groove (referred to as “groove 2” or the “distal groove”) is located distally from groove 1 . An elevated barrier is preserved between the two grooves. As will be described, the distal groove may be replaced with other forms to achieve its intended function. The grooves offer a unique capability for holding and positioning a connector; In addition, as will be shown, the grooves facilitate the assembly of the connection between two connectors Base ciamp (B-clamp) - Another aspect of the invention is a clamp that retains a set of joined connectors to preserve their connection and prevent leakage at the gaskets seal interface. A damping force is exerted on the connection to maintain the desired orientation of the connectors and to compresses the “O” rings of the Connectors against each other to form a leak proof seal. The following describes the B-clamp and its interaction with the connectors to achieve the desired clamping results: In its simplest form, the B~ciamp has. preferably, a rectangular box configuration with a hollow interior cavity which is also rectangular box. Two opposing walls of the box, juxtaposed and parallel to each other, form two sides of the B-clamp. The thickness of each of the opposing-wails or (key-walls) is equal or slightly less-than the width of the grooves 1 and 2 in the side of the connector. The two indicated walls are joined along 3 of their sides with connecting or bridging walls. The three sides between said key-wails complete the rectangular box; the fourth side remains open. At the open end, at the midpoint of each key- wall, a cutaway is introduced into each key- wall; the cutaway which extends from the open side to the proximity of the wall opposed to the open side, and where it terminates, preferably, as a semicircle. A semicircle is selected for added strength to tee “clamp” sides and corners and for positioning of connectors, as will be described. The width of the cutaway is dimensionally ’’similar" to the “ID" of grooves 1 and 2 in the side of the connector; for example, if the groove ID is circular, the said cutaway semicircle “ID" is similar to the diameter of the groove ID; if the groove “ID" is a “D" shape, the said cutaway semicircle “ID” ss similar to the diameter of the rounded portion of the “D". The connector can therefore be inserted with the side grooves into the cutaway and advanced towards info the culaway; at the end point the rounded groove ID will form a snug fit with the cutaway semicircle.
The width of the cutaway is not uniform; it is somewhat reduced at the proximity of toe open side of the clamp; the width of that opening is reduced so it is less than the IDs of the connector grooves.. That reduction in width in the cutaway opening or entrance, is to restrict or form a barrier to the insertion or extraction of a connector from the clamp. The degree of restriction is optional but it should not be insurmountable; when the clamp Cutaway walls are inserted into the connector groove(s). some force is required to overcome the initial smaller width of the cutaway to advance over the larger groove ID. Advancing the B~clamp cutaway over the groove ID force the clamp cutaway entrance to “expand” or separate by an amount required to overcome the grooves ID. After overcoming that barrier, the clamp will snap over the groove ID, securing the clamp at the connector groove. Similar force is required to extract the clamp from the groove, thus firmly securing the clamp and C-connector assembly.
Another function of the B-clamp Is to assure that joined connectors remain aligned and their joining is maintained with a specific compression force. That function is achieved by assuring that the distance between the proximal sides of groove 1 of in toe respective facing connectors is greater than the internal distance between the cutaways ;n the opposing wails of the ciamp. When two joined connectors are presented, with their respective grooves 1 , to the clamp at the cutaways, its apparent that the distance between the connector (grooves) must be reduced to fit into the clamp. Thai is simply achieved by pressing the connectors into the ciamp, which forces the connectors and their corresponding elastic gaskets together. Insertion of the ciamp at the connector grooves 1 secures ths connectors position relative to each other. A skilled person understands that adjusting the distance between proximal sides of corresponding grooves 1 or adjusting the internal distance between opposing walls on the damp may be used to set the clamping force between adjoining connectors. Therefore, the alignment of connector groove ID with the ciamp cutaway semicircle will maintain the connectors precisely aligned. That alignment is further secured by the inward force exerted by the ciamp wails on the connector grooves. Alignment Clamp (A~clamp) - The alignment clamp, unlike the base clamp (B~ clamp), is designed to align and retain two connectors, face to face, at their respective proximal ends. The A -damp is essential to the formation of that connection. it does so by enabling the orientation and positioning of two connectors, proximal face to face, and to allow merging and clamping the connectors in a precise orientation, Unlike the B- ciamp which is fixed dimensionally, the A~clamp is “scissor-like”, containing handles for opening and closing the A-clamp, which, in turn facilitates the reciprocal merger of the connectors as follows.
White the B-clamp joins and secures two adjacent connectors at the proximal grooves of the connectors, the clamp once applied remains in place for as long as the connection needs to be maintained. Should the B-clamp be removed, the connection will separate, exposing the flow path between the connecters to potential contamination. It is advantageous, therefore, to have a second clamp to keep the connectors secure and in position if and when the B-clamp needs to be removed. The A-clamp, unlike the B-clamp, attaches to the connector at the distal groove (D-groove). It can therefore securely retain the connection connected even when the proximal or B-clamp is either removed or added for any reason. Each A-clamp or B-clamp attaches to a coupled connection at the distal groove (groove 2) and proximal groove (groove 1), respectively, without overlap or interference.
The A-clamp has a “scissor like” configuration and comprises "U” like jaws. Such jaws can fit into the grooves 2 of the connector; where the other side of the scissor like device are handles. A fulcrum or a pin between the two ends of the “scissor-'’ allows it to be opened and closed. Pivoting about the said pin, a change in the angle between the handles proportionally changes in the angle between the jaws. In the “Open*' configuration, where the jaws are separated or angled away from each other, the U- shaped jaws (U-jaws) are each available for accepting a connector at the connector's distal groove with the proximal faces of the connectors positioned to move towards each ether - and be aligned -■ when the handles are moved closer to each other. Closing or reducing the angle between the handles will forces the jaws together, thereby forcing the connecter proximal faces end their corresponding gaskets together white compressing the gaskets or “O” rings against each other, thereby forming a sealed conduit. Locking the handles together with a lock mechanism, concomitantly locks the connectors against each other white they are still grasped by the A-clamp . in this manner, the proximal grooves are available to receive a B-ciamp, which once inserted into the proximal grooves, secures the connection even if the A-clamp is removed. Furthermore, with two new connectors inserted into the A-clamp jaws at D- groove with ths tabs aligned and pressed together as described above, the aligned tabs can be easily removed by pulling out ths tabs from the interface between the two connectors. Onus the tabs are extracted a B-clamp is inserted into the connectors1 proximal grooves io secure the connection. The A~clamp nan then be safely removed.
Conversion clamp (Oclamp) The A-clamp and B-clamp offer unique capabilities that enhance the handling of connectors so as to farm a secure, aseptic connection between two connectors according to the invention; however, it would be mom beneficial if that connection car- be severed and remade once or several times, with ths same connector or with another, new, connector. The C-ciamp offers that capability.
Like the A-clamp, it contains moveable "U" jaws that receive connectors at the distal groove 2; such jaws can also move apart, toward each other or Independently. An additional feature of ths C-ciamp is the ass of a feature or device that can generate a iocai decontamination zone which neutralizes any contaminating organism that may deposit in that area. Such a zone may bo generated, preferably, with heat but may be also generated by other means: radiation in ail its forms, chemical, electrons beam, a sterile air flow zone or a combination of such techniques or any other method that can generate such an aseptic zone or area, in the current case, heat is used to describe the process A heating ribbon, approximately 0 005“ thick (0.005 inches thick), is used to generate the heat required to form a sanitary zone in the vicinity of the heater. Such heating ribbons are commercially available and can be obtained with the required specifications, including size, thickness and power requirement. The heating ribbon being thin and fragile is reinforced by embedding between two sheets of material that increase the strength and stiffness of the resulting laminate. The sheet thsckness is minimized, preferably 0.002 to 0.010” width and its size is preferably about the size of the heating ribbon; for example, in one form, the heating ribbon is overlaid with thin “metal” sheets, whose dimensions are similar to the heating ribbon. (The term “sheet" is used interchangeably with “leaf, “shim", “strip” or "plate”). An example of a rectangular laminate can thus be formed. That is about 0.5" wide, 1.5“ long and 0.015” thick. The heating "element” within the heating ribbon is shielded from the metal leaves by embedding the conducting heating element between two layers of insulator, which preferably is high temperature polymers such as Kapton polyimide or the like. Applying electric current to the heating “element”, will generate the required level of heat in accordance with Ohm’s law. The insulator layers that encapsulate the eating element will also provide an insulating layer between the heating element and the overlayed metal sheets.
As indicated, the heating ribbon is placed between two harder plates for added strength and stiffness. A thin metal plate or sheet that, for example, may be 0.5” wide and 3" long, can simply be folded upon itself into two overlaying layers; the two halves are pressed together to form a sharp thin wedge about twice the thickness of the sheet. The thin heating ribbon, also 0.5” wide and 1.5” long in this example, Is inserted between the folded leaf halves to encapsulate the heater; therefore, for a shim that is 0.0Q5” thick and a besting ribbon that is also 0.005” thick, the resulting laminate is - 0 015” thick. The folded edge of the leaf strip may be further compressed, at the bent or leading edge, to form a sharper edge. This is preferably formed with a slightly stand- off between the leading edge of the heating ribbon and the bent edge of foe leaf fold. The leading edge or standoff can then be further compressed or sharpened without damaging the heating Him, (ribbon), inside. The contacts to the heating element may be exposed by removing the metal leaf segment overlaying the contact electrodes; the electrical connections may be achieved by other means that are common to one skilled in such techniques.
The formed laminated assembly or ’’heating wedge”, with the contained heater can then be partly inserted and connected to a grasping device that not only retains the heating wedge but also provides electrical contacts to form a closed circuit with the heating element
As indicated, the C-clamp contains a pair of C-jaws which are examples of U~ jaws that each can receive a connector with the proximal faces facing towards each other. Preferably a connector is inserted into its respective U-jaw when the jaw is in the “open” position or turned away from the long center axis, by about 45 degrees. This turning enables the insertion of the connector distal groove into the U-jaw without obstructions. Such insertion may be accomplished with both jaws similarly “open” or apart, or with one jaw turned while the other remains stationary and parallel to the long axis of the C-clamp, The clamp provides a mechanism for turning the jaws outward from the center axis and a mechanism for returning the Jaw to the parallel the center axis position
With both U-jaws mounted with connectors, the jaws can be returned to the axial position, whereat the connectors proximal faces and their respective protruding ”0* rings are pressed against each other to form a secure arrangement that maybe maneuvered and manipulated to perform other functions of the C-clamp, as follows:
With the U-jaws aligned axially, as above, the two connectors are similarly aligned; that is, in a manner that when the heated wedge is advanced, its “sharp” edge intersects at the midpoint between the connectors “0” rings, parting the O" rings. When the heated wedge is further advanced, its heated surface covers essentially the entire proximal face of the connectors. In that position, the interface between the connectors is sanitized with heat. One of the connectors may than be turned away from its axsal alignment. The other, remaining, connector is fixed in its position with the heater covering its face. The turned connector is then available for removal and exchange with a new connector. A new connector, protected with a tab or shield at its proximal face may be inserted into the U-jaw as before; it is than returned to the axial position to recontact the heater. The tab can than be removed followed by retraction of the heating wedge during which the connection between the corresponding “Orings” is than reestablished reforming the seal in between. At this point the B-clamp is inserted into the exposed corresponding proximal grooves to secure the connection. The coupled connection can than be removed from the U-jaws of the C-clamp.
The C-clamp process can be done fully (or partially) as a manual operation or fully (or partially) automated. it is also envisioned that the mechanism of the C-clamp may be enclosed and where the enclosure may be purged with sterile filtered air or sterilized with some gaseous or aerosolized agent. It should be noted that each operation involved in use of an A-clamp, B-Clamp, or C-Clamp described herein can be performed manually or otherwise for example, pneumatically, electromagrieticaliy and/ or by an automated device
Connectors and connector assemblies with multiple flow paths
While the Invention can be illustrated by one connector coupling to another connector. where both connectors contain a single flow path, i.e, one tube connected to another tube, it is envisioned that the described connector may contain more than one flow path per connector. Figl6 shows such a connector (156). where a single connector contains three flow paths. (The concept allows more than 3 or less than 3 flow paths per connector). The concept of making the concoction between two connectors according to the invention remains the same. The A-clamp and B~ciamp are used to form the connection in a similar manner to what has been described for the single flow path connectors. Tab (18) extraction is also similar: however, if the multiported (multi flow path) connectors are rectangular, the tab may be optionally extracted along the lung axis of the connectors or along their wide axis. The transfer of the connectors from the A-clamp io the B-clamp follows the same principles as before. The same is applicable to connector exchange using the C-clamp. Perspective views of two connector assemblies (154, 153) in which the lumen has a Y-shaped configuration are shown in Fig. 15
Fig. 16 shows three views schematically illustrating, sequentially top to bottom, the use of a B-clamp to stabilize the connection between two connector devices held by a C-Clamp and then stabilize the removal of the connected devices from the C-damp Fig. 17 shows two views schematically illustrating, sequentially top to bottom, the use of an A-Clamp to join two connectors (157, 158) devices in the case where each device has a forward surface opening that leads to a lumen that splits into three directions. More detailed description
The terminology is best understood by referring to the structures Hiustrated in the drawings. The preferred form of the shielded connector (10) for “small'' tubing is illustrated in Fig. 2. The unshielded form of the connector is shown in Figs 1-1C. The tube or channel (2) through the center axis of the connector may range, typically, from < 0.032” ID (internal diameter) to about 0,50” ID, although the use of smaller or larger tube IDs than the indicated range are also within the scope of the invention. The attachment of tube (8), with ID similar to the connector (1) channel ID (2) can be simply achieved by incorporating a barb adapter (9) emanating from the distal end (3) of th® connector. The elastomeric tube (8) ID is pressed onto the barb adapter (9), sliding over it, passed the barb(s), to secure the connection. Other adapters, other than the barb type, may also be incorporated at the distal end (3), as may be needed, to make varied connections of tubing or accessories. One such adapter, for example, may be tri-clamp (TC) type sanitary fittings; other type may be a compression fitting, a lure type in Its various forms, threaded, welding buts or yet other type fittings or coupling, as necessary to connect probes, samplers, perfusion devices, accessories, etc. An accessory or device positioned and aseptically secured within the particular distal adapter may than be coupled to another connector (1,10) or device at the proximal end using a reversible connection method of the invention.
A flange (20) at the proximal end (4) of the connector (1 ,10) provides the means for joining to another connector (1 .10). The flange (20) and its proximal face (5) is preferably square; although it need not be square. At the center of the proximal flange there is a gasket or O- ring groove (11), which, in turn contains a gasket or O-ring (12). Preferably the gasket is somewhat longer than the dept of the groove, so when placed in the groove, it protrudes or overhangs above the surface of the proximal face (5); preferably, the proximal end of the gasket overhang (13) is “fiaf or at least oval to maximize contact area between said gasket and the gasket of a corresponding connector (1). (See Fig. 2) Ths proximal face (5) of the flange is shielded or contains a tab (15) covering which is dimensionally the same or similar to the flange dimensions on three of its sides. On one side the shield extends from the flange face (5) about 1 .0-3.0 inches: the extended length is to permit grasping of the tab (15) at that extension. The preferred composition of the tab (15), include the following: Its preferably porous: for example, a 0.2u pore size, although other pore sizes that restrict ingress of contaminants, such as microorganisms, may be used. It’s also essential that the tab (15) material have a high melting point, greater than 125 degrees C; further, it should be mechanically strong and flexible, not easily tom when pulled. A number of materials meet those criteria, most notably polysulfones, polyesters, PEEK or other high-performance plastics. The connector and proximal flange surface (5) may also be formed from a number of different materials, preferably, polycarbonate, polypropylene, ABS, poiysulfbne, or others. But generally; the connector material has a lower melting point than the tab (15) material. A lower melting temperature of polycarbonate, for example, causes it to liquefy first at its melting point temperatures allows its 'welding” to the higher MP tabs (15). The welding is facilitated by application of heat and pressure to the higher MP tab while pressing it on to the polycarbonate face of the connector until a weld is formed.
Optionally, high temperature adhesives may be used to attach the tab to the proximal face of the connector. An example is a polysulfone. The tab may also be coated with a second layer of material that will facilitate the bonding of the tab to the connector. Ultrasound, laser welding, electromagnetic radiation , i.e.s radio frequency or combination thereof are some other methods that may be used perform this attachment. Prior to “welding* the tab, a side (19) of the tab (15) and a corresponding side of the flange proximal face (17) are aligned; from which side, the tab (15) is extended over the proximal face (5) of the connector. The tab is then attached or welded to that face, without gaps in between, to form an aseptic barrier. Its highly desirable that the Indicated weld results in a complete covering of the connector proximal fane (5) including the gasket (12) and the center “hump” (13) formed by the gasket (12). Once attached, the tab (15) Is folded upon itself as shown in Esq. 2 (Figure 2). Two “concentric” grooves (i.e. if the grooves are completely circular, they are concentric. If they are each part of a complete circle, then those circles if completed would be concentric), shown in Fig. 1, are placed at the periphery of the connector (1 JG). One groove or proximal groove (P-groove) (6) is positioned towards the proximal face of the connector. A second groove ;s positioned distally from P-groove (D-groove).
The two grooves are separated by a wall (21). While the P-groove ID is preferably circular and concentric about the center axis (14) of the connector, D-groove (?) “ID” is preferably “D* shaped and spaced "evenly” about the center axis (14) of the connectorfUO) . The function of the two grooves will become apparent. The reference to shielded connector (10) is the same as connector (1 ) without the shield (15).
Two unique clamps that are vital parts of the invention are described. Both clamps are designed tn grasp, position and look a paired of connectors together (1 ,10). The function of each clamp, however, is somewhat different but their objective is to form a reliable sanitary connection. The ciamp shown in Fig. 4 Is a dynamic or adjustable type ciamp, A-clamp (50).
The A-clamp contains two opposing U-jaws (U-shaped jaws) as A-jaws for receiving connectors (1 ,10). The function of the damp is to enable positioning the connectors within the jaws (45) and (46) prior to their joining. The positioning or movement of the jaws (45,46) is achieved by the reciprocal movement of handies (47) and (48), pivoting on a pin (49, 52). Pressing handies (4?) and (48) towards each other reduces the angle between them; concurrently and proportionally the A-jaws (45) and (48) are forced together. A stop (53) between the handies limits handles rotation towards each other: that limit, however, may be adjustable, so it may be used to set the precise distance between the A-jaws. A preferred position or distance may be set between the A-Jaws so that when connectors are set within said jaws, the connectors will be forced together with precise ferae. A spring mechanism, for example, at the stop limit may be used to generate a flexible “squeeze" force on the merged connectors. The stop limit may bo fixed, adjustable or flexible. A reversible lock or latch mechanism (54), as shown in Fig. 4, locks the assembly at the stop limit; the latch configuration shown is not limited to the one shown; for example, the solid latch may ba replaced with a spring or some flexible material that may impart a specific fetching force or flexib ility on the closure; this allows the handles and connectors to part if, for example, a greater reverse force is applied. Torsion spring (59) provides a counter force to the manual closing of the clamp; therefore, release of the latch (54) will open the handles as well as the jaws of the A- clamp.
As indicated the A-jaws (45,46) of the A-ciarnp (50) have a 'fo" form , where the bottom side of the “U" may be rounded or preferably a straight side, as shown in Fig.4. Also illustrated is a cross section “A-A” of an A-jaw (46). As shown, the cross section is a “T” shape. Parts made from synthetic materials will typical possess an inherent flexibility, flexural modulus. Such flexibility is not desirable when pressing two connectors together during their merger, it may cause the A-laws to buckle and cause the connectors to turn or separate from their ideal face to face parallel alignment. The frame (55) provides that structural reinforcement to the A-jaws. The increase in the a- jaws structural stiffness, however, may be achieved in various other ways, including the use of stiffer composite materials, redesign ths part or substituting with much stiffer metal parts; in the latter case, frame (55) may be totally eliminated. The center leg (56) of the “T is the part of the A~jaw which retains a connector (1 ,10) and it may be sufficiently stiff to retain the connectors io position without the need for the described frame (55). in the current description, however, the “top” (55) and “leg" (56) of the "T” form the frame for three sides of ths A-jaw, The 4th side (57) is open to receive the connector st the D-grooves (7). Insertion of the connector into the jaw opening (57) is best achieved when the jaws (45 and 45) are apart or in the "open” position, as occurs when clamp latch (54) is released. Torsion spring (59), forces handles (47,48) and the two jaws (45,46) “apart” . Once “opened”, connectors (1,10) may be conveniently inserted, at the D-groove (7) into the into the center “T” leg (58), through the jaw’s open side (57). The width of the center “T” leg is the width of the D-groove, allowing full insertion of the connector onto the jaws; additionally, the height of the center ”T" leg (56) is preferably the same as the depth of D-groove (7); This assures that the connector can fully mount the jaws at their D-grooves, Furthermore, the “square” nature of the laws, whose frame’s Inside dimensions are similar to those of the connector proximal flange (20) sides (17), provides a second mechanism for seating the connector inside the jaws; e.g., insertion of the connector into the A-jaws seats the connector proximal side (17) within the frame (58) of the A-jaw. This arrangement retains the connector by the jaws in two spots: At the square periphery of the connector proximal end and at the connector D-groove. The straight sides of the connector prevent the connector from rotating against the square frame (58) of the jaws.
As shown by the combination of Figs, 2 and 5, the connectors orientation within the jaws are with the distal ends (3) pointing outward, away from each other and the proximal ends (5) of the connectors pointing inward towards each other. The connectors in their respective A-jaws are in the same orientation, with the extensions of the tabs (15) of both connectors aligned and juxtaposed on each other. Therefore, when the A- clamp (50) is in the fully closed position, the proximal faces of the connector (10), inctoding gaskets (12) and tabs (15) of the respective connectors are forced against each other. That forced position may be locked-into place with a latch (54) as previously indicated. Suitable force is exerted on the connectors: so that, when the tabs (15) ar© pulled from between the connectors, sufficient compression force remains, to maintains the “squeezed state" on the Orings: such that no gap can form between the two O-rings or gaskets (12). "locking” the A-clamp with the two assembled connectors (10) also facilitates the extraction of the tabs by providing a structure in which both the ciamp and tabs can bo securely gripped and pulled apart. The connection may be maintained as long as the assembly is locke together with the A-clamp lock (54).
Another clamp of the invention is the basic clamp, or “B-clamp” (30), shown for example in Figs. 3A-3C-, The B-clamp (30) fastens together two connectors face to face, it does so by pressing the connectors together with sufficient force to compressed their gaskets against each other. (See for example. Figs. 5B-5D) Unlike the A-clamp, the B- clamp fastens the paired connectors at the P-grooves (6). Ths B~clamp and A-ciarnp are not mutually exclusive: they may be considered as two separate devices that may be used synergistically to tour; aod secure a sanitary connection between two connectors (1). Therefore, while the A-clamp (50) enables the handling and joining of shielded connectors (10) and temporarily maintaining such connection, the B-clamp (30) provides a more secure and “convenient” functional arrangement of the connection, in other words, the advantages of the two-step con rmchan is; (1), The A-clarnp provides a stable platform for immobilizing and aligning the connectors. It also provides the means for pressing the attached connectors together and their respective gaskets together, which seals the flow path between them; addifsonaily immobilizing the connectors together facilitates extraction of the tab (15) and enables the transfer of the connection to the B-ciarnp in a secure manner that doesn't compromise sterility during the transfer, (2), The B-clamp, in turn, removes the connection from the A-clamp and makes such connection more permeant and convenient. The functional benefit of such a two-stage approach will be discussed further on; however, some other benefit includes the ability to miniaturize the B-clamp and to eliminate any moving parts. The resulting smaller size of the B-clamped plus connectors assembly minimizes interference between adjacent connections, particularly when “packed" in a confined space. Miniaturization has other advantages, for example, the ability to scale down of certain processes, i.e., miniaturization cell culture systems, organ perfusion, and certain analytic processes can all benefit from a reduction in process size.
Referring to Figs. 3A arte 3C). the B-clamp (30} contains two "major" sides (25) of defined thickness (34) and a “C” or "U” shaped cut-out (35) in each major ssde (25). Three other “minor55 sides (26.27,28) in combination with the major sides of the clamp, form a Cavity within the clamp. The fourth “minor side (29) remains open. An optional B-clamp handle (38) simplifies handling of the small damp. The thickness of each major side (25) is equal or less by about 0.002-0.010" than the width of a connector proximal P~groove. This allows rhe damp sides (25) to be inserted at the cut-out (35) mtu the respective P-grooves. The cut-outs within the two major sides (25) of the clamp are inserted at the open end (29) of the clamp onto the respective P-grooves (6) of the facing connectors. However, the internal distance, DI , between the B-ciamp's two major sides (25) is less than the distance D2 between the proximal sides of the paired P greaves (6). As a result, insertion of the clamp into the P-grooves forces the two connecters (1) together by the difference D1-D2. The “O” rings or gaskets between the connectors will be compressed by the same amount, D1-D2. That difference is such as to form a seal between the elastomeric gaskets (12). No additional compression of the gaskets is required, however, when the Connectors are transferred from the A-clamp to the B-ciamp, since the connectors are already in the compressed state in the first damp.
Additional features of the indicated cut-out (35) of the B-clamp are:
(I), The cut-out (35) long axis originates at the midpoint of side (29) and extends towards the midpoint of the opposing minor side (28). The cutout terminates as a semicircular surface (39), where its perimeter is a distance. DO, from the infernal wall (36) of side (28); a standoff (37) is thus created from surface (38) to the semi-circular surface (39) perimeter. The standoffs (37) height is preferably equal to the depth of the P- groove (IS), (as measured from the P-groove’s ID, to the midpoint of the flange proximal side (17))
(ii), The width of the void created by the cut-out (35), D4, at its widest point is preferably equal or slightly greater (by about 0.002-0.010”) than the ID of the P-groove (8). The internal height, D5, between opposing minor walls (28,27) of the B-clamp is equal or greater than the width of the proximal flange side (17) by about (0.002-0.010). The difference between D4 and OS is also about 2X the height of standoff (37) or the depth of a P-groove (6), as described. The remaining material in the major side wails (23), excluding ths cut-out (35), remain and are continuous with their, respective adjoining minor wall sides (26,27,28). A set of haws”, B-jaws, (32,33) are thus formed, one above and one below the cut-out segment (35). (hi) , another feature of the cut-out (35) is the contours of each of its sides (See for example, Fig. 3C): At the forward ends of the B-jaws, (at the open minor side (29)) there are chamfered segments (48) that angle inwardly, into the cut-out, at approximately a 45 degree angle. The inner side of such a chamfered segment itself is also chamfered inward via a chamfer (42), into the clamp. The resulting enlarged opening between the jaws and also its beveling inward at front of the jaws facilitates the aiignn-'wst of the jaw sides with corresponding P grooves of the paired connectors. Advancing the clamp open side (29) beyond the said chamfers, towards the teeth (41) of the jaws, the width of the cut-out Is less than the width further into the cut-out towards the semicircular surface (39). It is also less than the inner diameter of P-grooves (6); therefore, when inserting the B-clamp into the corresponding P-grooves, a force is necessary to overcome the narrower gap at the front end between ths B-jaws, to overcome the larger inner diameter (ID) P-groove circular inner surface. A level of flexibility in the material of the B-clamp allows the jaws of the ciamp to bend and separate when forced on to the P-grooves, Pushing the B-clamp further will cause it to advance over the P-grooves circular inner surface. Once the jaws (32:33) teeth (41) clear the P~groove ID, they will snap over the P-grooves: beyond that, the width of the cutout and the ID of the P groove become about the same. The connectors con be advanced with minimum restriction all the way Into the cutout until the P~groove‘s ID center aligns with the center of the semicircular surface (39). The close tolerance (•• 0.005-0.005) between P-groove ID and semicircle’s diameter will accurately position and retain the connector (at P-groove) within the B-clamp: in addition, at that point, the connector proximal flange side (16,17) will hove advanced deeper into the B-ciamp towards inner side of the minor clamp wall (36); the minimal difference between standoff (37) and the depth of P -groove (6) am such (hat when the semicircular inner surface (39) contacts the P-groove inner surface, the proximal flange side (17) will also butt against the inside of minor wall (28) (36); that is, when the connectors’ ’’square" flange sides (square except for the missing upper horizontal side) are fixed within the square sides of the B-ciamp, they are fixed in position and cannot rotate. Similar to the force required for insertion the connector into the B-ciamp. is the force required for its removal; Therefore, a barrier exists against spontaneous dislodging of the connector from the clamp.
As indicated, the A-clamp and B-clamp are devices that may be used separately or in tandem to form and secure aseptic connection between two connectors (1 ,10), In which case, the connectors and their respective gaskets (12), are also pressed against each other into a compressed sealed state. The latch mechanism (54) secures that combined state of the connectors. The B-clamp, on the other hand., may receive the oriented connectors, from the A-clamp in the compressed state. The transfer occurs with the connectors compressed provided It is attached to st least one of the clamps. Once connectors have been removed from the A-clamp (50), it becomes available to make another aseptic connection. A sequence of these transfers is illustrated in Fig 5A to 5D. Both Figures 5A and 58 show the position of the connectors (10) with their tabs (15) exposed and with their D-grocves (7) within the "open” A-jaws of the A-clamp (50), Fig. 5B shows the same connectors (10) with the A-jaws “Closed” and the clamp latched (38) closed. Once the tabs (15) are removed from between the connectors (10) Figs 5B and 5C, the connectors (1) become available for Insertion of the B-clamp (30), between the A-jaws, into the exposed P~grooves (6) of the connectors. The combination of Figs. 5C and 5D shew the preferred alignment of the B-clamp relative to the A-clamp prior and after combining the clamps. The B-clamp jaws (32, 33) are fully inserted into the exposed P-grooves of the connectors: at which point, the connectors are retained by both the B-clamp and the A-clamp, Removing either clamp, one at a time, will retain the connection secure within the jaws of the unremoved assembly. The B-clamp with attached connectors (B-clamp assembly) (31)) is shown in Fig 5D.
The removed connectors and B-clamp assembly (31) farms and retains a convenient complete aseptic connection. Ths A-dampt with its connectors removed becomes available for making another aseptic connection, as described. Note that adding the B-clamp to trie A-clamp-connector assembly (51 ) is preferably with the B-ciamp Open side (29) entering the P-grooves of the connectors in the A-clamp at 99 degrees to the A-jaws Open side (57). In this manner, the B-ciamp can be added to ths A-clamp without interference.
The combined use of the "A" and “B” clamps increase the functional capability for making and breaking aseptic connections; In the second case, simply reinsert the B- clamp assembly (31), into the A-clamp jaws (open side (57)), when the A-jaws are “closed’end aligned to receive connectors at the exposed D-grooves (Fig SC). The A- jaws am preferably lucked in the “closed” position with latch (54). The insertion of the said assembly is again preferable with the open sides of the B-clamp at 90 degrees to the open side of the A-jaws. An assembly of the two clamps sharing a set of connectors is thus formed. The B-clamp clamp can now be removed, and the connectors remain with the A-clamp. Opening the A-clamp jaws, results in exposing the connectors proximal face and premits the removal one or both connectors. To maintain aseptic conditions the described process san be conducted in an aseptic environment, like a biological safety hood. The C-clamp (70) - Like the 8-damp and the A-damp, the C-ciamp further extends the ability of the invention to form aseptic connections in a reversible manner. Where the B-clamp and A-damp function to form essentially a single aseptic connection, the C-damp is capable of separating that connection in the open, not in a biological safety hood, while retaining the sterility of at least one of the connectors (1). The retained connector (1 ) may than becomes available for making another connection, with another connector (1 , 10).
The C-clamp may be used in two primary ways:
1. The C-damp is similar to the A-damp (5D) in that they perform similar tasks, ie, managing the connectors during their assembly, in addition to facilitating extraction of the tab (15), and transfer the pasted connectors to the B-clamp. Also like in the A-damp, the C-damp (70), captures the connectors at their respective jaws (81,82) at the D-grooves (7). This aligns the connectors, face to face, with the tabs (15) also aligned and compressed between the connectors like described for the A-damp, and like the A-damp , the aligned tabs that extend out from the C-jaws can be removed with a puli action on the tabs while keeping the C-clamp anchored, FIGs 6A-6C. In both cases, the gaskets (12) will remain compressed against each following extraction of the tabs, keeping the flow path through the connectors sealed and protected tram external contaminants: furthermore, aisa like with ths A-damp, the attached connectors in the G- jaws become available to be transferred to the B-clamp, Fig 6D-6F: again, as before, by insertion of 8-damp jaws into the exposed P-grooves of the retained connectors. Removal of the 8-damp assembly (31) from between the C-jaws is accomplished by withdrawal the 8-ciamp assembly (31) from the open side (80) of the C-jaws (81,82).
Unlike movement of the A-damp jaws, however, the movement of the C-damp jaws may be controlled simultaneously or independently of each other. This functionality will be described further on.
2, Another function of the C-ciamp is to provide a temporary aseptic environment to one or both connectors that are within its jaws (81 ,82). This function could be provided to one connector in one of the C-jaws or both connectors contmed to their respective C-jaws (81 ,82). in the current description, the indicated aseptic environment is provided with heat by generating a heat envelope or barrier at an exposed, proximal surface (5) of the connector (1 , 10) or at the interface between touching connectors. While, as indicated, there may be a number of ways that an aseptic environment may be generated, In the current case the preferred method is heat. More specificaiiy. the heat generated is with heating wedge (83). A preferred form of that heating wedge (83) is shown in Fig 8. The heating element (86) within the wedge (83) is a “high8 temperature nonconductive ribbon (85) in which there is an embedded conductive heating coil (87). Applying an electrical current at the contact terminals (88, ■99 89) of the heating element (86) provides the electric current, through conductors (90,91). to the conductive heating coil (87). The amount of heat dissipated from the coil is related to power loss across a resistor in accordance with Ohm's law. As shown in Fig. 8. the heating element (86) is layered between two strips or leafs (93.94). Such leafs may be two separate strips of metal or they may consist of one longer strip of material folded on itself at about midpoint of its length. Prior io addition of the heating element (86) between the folded leafs, however, the folded leafs (93,94) may be pressed together at high pressure. This pressure or force is focused primarily on the fold end of the strip, approximately 1mm +/- 0.5mm from the folded end (96). The objective of the applied force is to create a fiat, narrow, standoff (97). Alternatively, one may place a ‘'spacer”, with the same thickness as the heating element (86) between the folded leafs prior to application of said pressure or force. The spacer is positioned with one of its ends about 1mm +/~ 0.6mm from the folded end (96). Thus when pressure is applied, an impression of the spacer is created, with a narrowed standoff (97) from the folded end (96). The impression may than receive the heating element (86) without damaging it; preferably the heating coil (87) side of the heating element facing towards the folded side (96,97). The resulting thickness of the formed laminate (83) is thus minimized to form a thin heating wedge (83) for slicing between the gaskets (12) between the connectors. The width of the heating wedge (83) is about the same as the width of a connecters (1.10) proximal flange side (17). Advancing me heating wedge (83) from one side of the face (5) to the opposite side covers the entire face of a connector’s face. The heating coil (87) area within the heating wedge (83) is such, that it too, covers the connector’s face (5). The heating area of the heating wedge (83) can, therefore cover all or much of, the critical areas on the proximal face of a connector.
Another preferred feature of the heating wedge (83); other then a desired thinness, is also a high degree of stiffness; that is, what is preferred is a heating wedge that is very thin yet very ridged. That is, so it may more easily penetrate between the adjoining faces of the combined connectors and also penetrate between their respective adjoining gaskets (12), and do so, with minimal damage to such gaskets To facilitate that concept, the front edge (96) of the wedge (83) including the standoff (97) form a “sharper” leading edge that is narrower than the remainder of the wedge (83); ie, this leading edge does not contain the added thickness of the heating element. (86), Figs 8 and 9. The narrower leading edge (96) facilitates the insertion of the heating wedge (83) between the paired set of connectors, as well as insertion between the gaskets (12). To maintain the “narrowness” of the heating wedge (83), the heating element (86) thickness is minimized, preferably in the range from 0.002 to 0.010”. A heating element with thickness in that range is achievable with Kapton as supporting material. Kapton is a preferred material it has a very high melting point, >200 deg C, it's a good insulator, and sis relatively stiff, Fig 8. Similarly, the leafs (93,94) of the wedge (83) are selected from materials that are also stiff, even whan very thin. Some such materials are metals, including stainless steel or its various alloys, Titanium, nickel alloys, offers a selection of potentially suitable materials. Preferably, a high strength 17-4 PH stainless steel may be used because the steel is reasonably workable in one state with hardness of C30 (Rockwell hardness), but then it may be surface hardened to C48 and stiffened by subsequent treatment for desired results. For example, the bending of the leafs end pressing the leading edge to term standoff (97) is performed when the material is soft, Once termed to the desired shape, the leaf material may be hardened. The preferred thickness of the leaf material may be 0 002 to 0.006", more preferable is a thickness 0,005”.
Since heating wedge (83) consists of two external leafs (93,94), 0,005" inches thick each and heating element (86), is approximately 0.005" thick, it adds up to a total thickness of the wedge that is 0.015”. That thickness may be modified as needed preferably in the range */~0.005. Figs 8,9. At that thickness, the heating wedge (83) readily penetrate the gap (23) between the connectors (1 ,10) within the jaws of the C- clamp. The wedge horizontal movement is perpendicular to the vertical axis through the open side of the C~jaws (80). This allows the wedge to penetrate the gap between the connectors with some force without dislodging the connectors from the jaws. The same heating wedge (83) can then be advanced further into the gap between the connectors, into the interface between gaskets or Orings (12)s Fig 9.
The elastic gaskets (12) that protrude above the plane of each of the proximal faces (5), by about 00302 forms a gap (23) of about <0.060“ between the connectors; (not accounting for compression of the gaskets). The remainder of the gasket (12) sits below the plane of the proximal face (5) within O-ring groove (11), about 0.20” deep. With two gasket® tana to face, the combined length of both gaskets is s 0.4802 Insertion of heating wedge (83), with total thickness of about 0.020“, between the gaskets will cause the gaskets to compress less than 5%. That level of compression can be easily tolerated by the most gaskets, without damage; furthermore, the leading edge of the heating wedge (83) is not only thinner at -0.016“, it’s also designed to minimize damaging the gaskets upon insertion. Wham a sharp edge (96) may slice through the gasket, a more blunt and rounded edge will not cut through the gaskets; but rather, it 'will part or separate the gaskets as it is forced in between such gaskets (12); for example, leafs (03,94) (material that is 0.005” thick but when folded on itself, and the fold compressed, will generate a hemispherical edge with a diameter of 0.010296). This narrow yet rounded edge facilitates insertion between the gaskets without cutting. The gaskets or “O” rings, each having a rounded or doughnut like profile will form a recess (22) between them when pressed together, (See Fig. 9) The heating wedge's leading edge (96) will be directed at the center of the said recess. The edge (96), will readily compress and part the gaskets. The heating wedge (83) can therefore be advanced until it fully covers the gaskets and proximal face (5) of the connectors.
An activated beating wedge (83) (one in which current flows through the heating noli (87)) will generate a heat field. The radiating heat originates predominantly from the region of the wedge that contains the healing coil (87). As indicated, the heating coii area is preferably the size of ths proximal face (5) of the connector. When the heating wedge (83) is fully inserted in between the connectors it is also fully parallel aligned with the connector faces exposing them to the heat radiating from the wedge. While the temperature of the heating wedge can be varied, it’s preferable to select a temperature that will not harm the components or parts of the connectors, nor damage the components of the heating wedge itself and which will allow reasonable confinement of the heat field or temperature to the interface between the connectors. Another consideration is that the magnitude of the temperature selected needs to be capable of neutralizing any contaminants situated between the faced connectors, and to do so in a reasonable time period. A temperature range between 120° C and 150° C is a preferred range for achieve those requirements, A preferred working temperature range is 130°C to 135° C. All the components that are in direct proximity to the heating wedge (S3) or that contact the wedge are consistent with surviving exposure at such temperatures. Controlling the temperature and timing the duration of heat exposure can be adjusted or varied to reduce the indicated adverse effects of prolonged heating while maximizing the intended bioburden deactivation effects.
The primary function of a C-clamp is to allow aseptic joining and exchange of connectors, a process that may be approached or achieved with somewhat different steps; in general, however, the following describes one such processes (See the combination of Figs 6A-6F, 7A-C, The process initially requires an aseptic disassembly of a clamped pair of connectors (1,10). An overview of the precess involves: Transfer the B-clamp-connector pair assembly (31) to the C-clamp (70); remove the B-clamp but retain ths pair of connectors using the C-clamp. Activate the heating element in ths heating wedge by turning on its power switch Onus the wedge achieves the desired temperature, insert the heating wedge (83) between the connectors. Retain the hot heating wedge therein for a sufficient period, Separate the C-iaws by moving one them relative to the other and remove one of the connectors white maintaining the aseptic (heated) environment of the remaining connector until another connector (10) can be added to the moved C-jaw; Close the C-jaws of the ciamp; following a defined period, remove the tab (15). Withdraw the heating wedge. Recombine the connectors with a B- ciamp to secure and remove the new aseptic connection from the C-clamp. The C~ lamp provides the mechanism to carry out the described steps. The following provides a more defoiled description:
Fig. 6.A and 6B show examples of the C-ciamp with its jaws (81 ,82) in the “Open* and “Closed” position. Opening of the jaws is achieved by rotating the Jaws about the center axis of pin (130,131). Typically, that degree of rotation is in the range between 0 - 90 degrees. When at 0 degrees, the jaws are “Closed” and are parallel to each other and to the clamp long center axis (110). At 90 degrees, in the fully “open” position, the jaws are perpendicular to the long center axis (110). Preferably, an open position of 45 degrees or some other angle may be selected.. Fig. 6A shows the connectors (1 ,10) inserted at the D-gruoves (7) into the Cgaws, set to about 30 degrees. Mote that at that angle, the folded tab (15) of the connector (10) is easily accommodated, simply extending in the forward direction, away from the body of the C-clamp. The tab can also be accommodated within the jaws when the jaws are in either 90 degrees or at 0 degrees orientation The connectors may also be inserted into the jaws of the C-clamp with their tab (IS) extending in the downward direction. The tab can be extracted from between the connectors in either orientation, “down or out”. selected degree or compression regmres that wnen ins tabs (15) sne removed, the exposeo touching gaskets remain compressed against each other, aioest, to a sesser Oeg res.
Capturing the connectors between tne closed jaws, with the tabs ( 13} extended, allows one io grip the C-clamp and tabs simultaneously then pulling the two apart to extract the tab. Preferably; the C-ciamp is gripped by the handle (72) with one hand and jaws, regardless whether ths tabs are extracted outwardly or downward from ths jaws.
With tabs extracted, the connectors will remain firmly attached with their gaskets (12) compressed and seated. To secure that connection, a B-clamp is inserted into the P- grooves (6) of the connectors, as previously described. The B-clamp-connector assembly (31) can then be removed from the jaws through its open side (80). Conversely, to sever the connection between B-clamp- connectors (31), insert the assembly at D-grooves (7) into the open sides of the C-clamp jaws. Insert with the open sides of the respective clamps at 90 degrees to each other. The B-clamp can then be removed by holding the C-clamp (70) and B-clamp (30) and pulling apart. The connectors wilt be retained by the wall of the C-jaw and the B-olamp will disengage at its open end (29), Once the B-clamp is removed, the connectors can be separated in a sanitary manner, as follows: in order to exchange one connector with another, it is necessary to separate the two connectors at ths gaskets (12) and then reform the connection at the gaskets(12) . (See the combination of Figs, 6A-6F and 7A-7C). To achieve such separation in an aseptic manner, however, the gaskets (12) and proximal faces of the connectors must be protected against possible contamination. Such protection of the exposed surfaces, as previously indioated, is achieved by insertion of a heating wedge (83) between the attached connectors and heat sterilizing that interface Fig 9. The wedge progresses from one side of the proximal flange (5), forcing the leading edge (93) of the hot wedge between and through the gaskets (12), ail the way across, to the other side of the proximal flange (5). in that position the hot heating coil (87), within the heating wedge (83) covers essentially the entire face of each connector. Following a heat sanitization period, one of the connectors can be removed from the clamp after “opening” the corresponding jaw. The remaining connectors proximal face remains shielded with the hoi heating wedge (83). The heating of the proximal surface of the remaining Connector can be maintained until a new connector, with a protective tab (15) is inserted into the emptied "Open jaw, as previously described. “Closing” the "'opened “jaws, rejoins the new connector with the heating wedge (83) and forces both connectors towards each other and against the heating wedge (83). The heating wedge that remained between the connectors will subject the connectors to a sanitizing environment. Removing the tab of the added connector, will reestablish the contact between each connecter proximal face (3) against the heating wedge, at which point the heating wedge (83) can be withdrawn, which, in turn, allows the two proximal gaskets (12) to reestablish direct contact. As indicated, in the closed position the jaws force ths connectors and the corresponding gaskets against each other, to reestablish a sealed sanitary flow path. To secure the connection between the jaws prior to removal, a B -clamp is reinserted into the P-grooves (6) of the connectors, and the assembly (31) removed, as before, from the open side (80) of the C-clamp jaws.
Insertion of the shielded connectors (10) into C-jaws is preferably performed when the jaws are ‘Open”. The jaws can open and close reversibly and independently, a process that Is controlled by a mechanical push-bars (104, 105). That mechanism is best understood if the c-Jaw structure is further elaborated Figs IGA-10C . The term c- jaw refers to the connector gripping segments) (81 ,82): that segment itself is a constituent of a more extensive part, the C-cog (106,107). Ths C-cog consists of three general segments, the c~jaw (81 ,82), pivot hole and pin (130,131) and cam segment (108,109). The c-Jaws function was described; however, the mechanism that controls the movement of the c-jaws relies on the entire C-cog (1 OS, 107), more specifically , on the cam segment (108,109). Simply, the cam translates a linear force to a rotational force. As illustrated in Fig 10A-10C and 11, the action of the push bar (104,105) is linear in nature. The motion of the push bar can be either away (pull) from the C-cog (108,107) or (push) toward it. The manual pulling action is with pull-handie (77). The pull distance is limited by the pitch of a linear ratcheting gear (113) and pawl (114); that is, as shown in Fig 13, the ratchet and pawl engage following a specified pull distance by the handles (77). The ratchet (113) and pawl (114) remain securely engaged by the action of a torsion spring (112), which forces the two parts together and to remain engaged without slippage. Additionally, when the push bar (104,105) is pulled with puli handle (7?) for a specified distance, it also compresses push bar compression spring (103) the same distance. The spring remains in the compressed state as long as rise i sstehm and pawl remain engaged. Pressing down on the pawl handle (118) te overcame the torsion spring (112) force, will disengage the ratchet from the pawl, allowing compressed push bar spring (103) to advance the push bar (104,105) back towards the cam section (108, 109) of the C-cog {196,107). The advance of the head (120) of the push bar, will engage the cam arms (98) Fig 11. The configuration of the head (120) can determine the extent of its effect on the cam movement, and thereby on the C-jaws movement. in one configuration the head (120) consists of a segment (122) extending “outwardly” in a perpendicular direction from a plane of the push bar. An arc (124) emanating from the top of the segment (122) extends towards the forward end (126) of the push bar. Taking those features into account in conjunction with the detailed configuration of the cam arm (98) shows the interaction of the push bar with the cam., as follows.
Illustrated in Fig.11 is a form of the C-cog (106,107). A dowel pin or shoulder screw (131) in hole (130) provides a place tor a pivot pin about which the C-cog (166,107) may rotate; thereby creating an effect on the cam arm (98), reciprocally effects the C-jaws (81 ,82). In the “dosed" position, the c-jaws (81 ,82) are aligned parallel to each other and to ths long axis (110); the axis which also defines plane bisecting the C-clamp; in that closed position, the C-jaws are taken to be at 0 degrees to each other and to the center axis. To open the C-jaws, their direction of rotation is in opposite directions, away from each other. Their range of rotation, 0 to 90 degrees, is determined by the degree of rotation of the C-cog, which in turn is determined by the extend that the push bar head (126) and its forward edge (122) are pulled away from the cam segment (108,169) ). The cam configuration Is therefore also a factor in cog rotation; this is further explained, as follows;
The cam segment (168,109), each consist of two general sections; The body of the segment (99) and its extension, the cam arm (98); the body consists of a pad (132) of a semicircle whose radius is larger than the pivoting hole (130) radius. The origin of the semicircle (132) is an imaginary point on the circle that intersects the center line between the two pivot holes (130), when the C-jaws are at 0 degrees. The initial radius of the semicircle (132) may be constant or transitional In which case the original radius changes either to a serger radius or to a progressively larger radius. Such a transitional change is evident from the fact that the tangent to the curve changes as one moves along the curve. The semicircle radius changes or the corresponding tangential changes are ones that will allow movement of the push bar to result In rotation of the c- cog. One may envision that the transitions into progressive larger radii may further transition into a straight segment. Such transitions are preferably continuous and smooth. The extent of radii transitions, length of the straight segment, its shape, and angle of the cam arm (98) relative to the tong axis (110) may be varied to achieve the desired turning action of ths C-cogs, and to optimize its interaction with ths push bars (104,105),
Figs. 10A-10C show the preferred alignments between the push bars (104,105) and the C-cog (106,107). To illustrate the working mechanism between the two parts, three top view positions are illustrated Figs 1CA-10C. The first is a “Closed” (0 degrees) position. Fig 10A: The C-jaws are paraitei to each other and to the long axis (110), in that position, toe push bars (104,105) are fully advanced forward, and the forward force is maintained with a compression spring (103) A contact edge (123) of the past? bar is forced against toe back side of the angled cam arm (113) forcing the cam arm forward . The center of rotation of the cam arm (98) is a pivot hole (130). The cam long axis (101) extends at an angle of about 45 degrees from the C-cog long axis (111), taken to be at zero degrees). (The C-cog tong axis extends from the center of the C-cog pivot hole to the end of the C-jaw most distal to the C~cog pivot hole; Fig. IGA has a better representation of the position of the C-cog Iona axis than Fig. 11 to). The rotational angle of a cam arm (98) may range between 0 and some other angle toss than 90 degrees as shown in Figs. 10 and 11 , The length of toe earn arm (98) and its angle may be selected as needed to achieve the desired rotation cf the C-jaws . Particularly significant is the back side (115) of the cam arm. as it is the part that contacts the push bar head (123). its apparent that if a linear force that Is applied by the push bar to the back of the angled cam arm, it will cause the cam arm and C-cog to rotate In the same direction, about toe pivot pin. The rotation of the cam will be forward and outward from the center axis. Reciprocally, the C-jaws of the same Cog will be forced to rotate in the same direction: but in this case the rotation cf the C-jaws will be inwardly, towards the center axis (110). Stop pegs (127,128) prevent the C-jaws from over rotation and provide a precise stop for tiro C-jaws alignment with the center long axis (110), preferably at zero degrees. Compression spring (103) specifications are selected to provide sufficient force for closing the C-jaws and force connectors (1 > within those jaws together. The decompression force of the springs should preferably be of a magnitude that will permit extraction of tabs (15), yet maintain gaskets (12) compressed against each other. Additionally, that force should also overcome the force of leaf springs (102), which exert a force direction that is “inwardly” or perpendicularly towards the long axis (110). That force is set against the angled cam arm (98) is also in opposite direction to the force of the compression springs (103). Where the compression springs (103) force direction is to close C-jaws, leaf springs (102) force the C-jaws to open. Ths compression spring force, however, should be of sufficient magnitude to overcome the Inward force of the leaf spring force; yet, it should not bo of such high magnitude as to prevent parting of the connectors during insertion of heating wedge (83) between the connectors.
A second position of the C-jaws Is shown in Fig 10B. In which case, the C-jaws am in partially opened state . Retraction of either push bar (104,105) by pulling on either of their respective handles (77) overcomes the decompression force exerted by compression spring ( 103) on the cam A partial pulling back of the push bar, and withdrawal the push bar heads (120) from the cam-arm allows leaf-spring (102) to overcome the reduced resistance or force exerted by the compression spring (103) on the cam arm. The inward force by the leaf spring (102) can than force the cam arm to rotate towards the center long axis (110) and reciprocally cause the c-Jaws to rotate “outwardly” to open the C-jaws. The degree of rotation is related to the extent the push bar head was retracted from the cam-arm; i.e., the greater ths retraction, the greater the gap between push bar head and cam arm, the greater the degree of rotation by the C- cog: therefore, as the cam-arm is being forced towards the long center axis (110) by the leaf-spring, the C-cog rotation about pin (131) causes a reciprocal outward turning of the c-Jaws.
The third case Fig.lOG, the C-jaws are fuily open st some preferred angle from the center axis. The extent of the opening of either c-Jaw separately or both simultaneously, depends on the retraction of the corresponding push bars. Maximum opening of the C-jaws may be set by the retraction pitch of the push bar. That pitch is optionally cieterrriined by the ratchet gear and pawl as previously described.
It can be seen from the foregoing that the extent of the rotation or positioning of the C-jaws is be determined by a number of factors, including but not limited to: Extent of push bar retraction, angle and length of cam extension arm (98), extent of springs (102) allowable travel distances.
The described method describes but one approach to controlling the activities of the C-clamp. For instance, the degree of rotation of the C~iaws may be achieved in a number of other ways or mechanisms, including: Rack and pinion, worm gears, gears, pulleys, pneumatic or electromagnetic positioners, motors including any combination thereof or ether methods.
The C-clamp provides a platform for making and exchanging connectors aseptically and conveniently. To facilitate the clamp’s functionality, the device contains a “narrow” extended portion (69) to which front end (71) the C-jaws (81 ,82) are attached Figs. 6 and 7. The extended body or “nozzle" (69) provides the means for reaching into “confined” spaces, where it may be necessary to form or replace a connector in an aseptic manner. In hard-to-reach spaces or confining work areas, it is highly beneficial that the nozzle portion of the C-clamp is separated from the “bulky” body of the clamp. In the configuration described, one may reach short segments of tubing that cannot be extended from their point of origin to a device requires to forms an aseptic connection; i.e., tube welder: for example, a short length of tubing emanating from a pump, and which requires connection to another connector may not be easily accessible with a standard tube welder (ref.). With an extended nozzle of the C-clamp, that problem may be overcome. The described configuration is not limited to application of the invention, it does not exclude other configurations of the C-clamp.
White the nozzte (89) provides a convenient access io the connection site, the C- olamp body is constructed to support the other function of the C-clamp and to house its other essential components. A “pistol” shape device, as in Figs. 6,7 and 12, offers a number of usefid parts, including a handle (72) for holding, moving and manipulating the clamp. A trigger (73) that is positioned in front of the handle (72) is an arrangement which shows easy access io the tagger with the user’s index finger of the hand holding the C-clamp at the handle (72). Similar to a “pistol”. the nozzle extends the c-daws from the body of the C-clamp to the proximity of the connection. At the base of the C-clamp handle (72), a battery pack housing (74) is provided to receive a batery (75). The battery may be rechargeable. The batteiy may be recharged within the batery pack housing (74) by common methods or the battery may be removable through an opening (79) with a latched dour (67) on a hinge (68), and recharged externally, as is commonly practiced.
The batery, electrical connections, wiring, sensors are easily accommodated within the battery housing (74) and handle (72). The components may be wired as needed to provide the heating element (86) with the power density, Watts/cm2- necessary to achieve the desired temperature at the faces of the heating wedge (83). Furthermore, the batery pack (74,75) at the botom of the handle (72) provides a stable base far the entire C-clamp. Its weight, sis shape and position the center of gravity low near the battery, provides a platform which allows placement of the C-clamp on any fiat surface, where it can stably remain without tipping From that position it may be easily grasp at the handle for use. An indent at the top and back part of the handle facilitates the gripping of the C-clamp between the thumb and index finger while the length and shape of the handle facilitates a stable grip. The trigger (73) at the front end of the handle may be conveniently accessed with the index finger or several fingers The primary function of the trigger mechanism is to advance the rail bar (84) with attached heating wedge (83) towards the connectors and to insert the heating wedge between the connectors, The heating wedge may be activated or powered before insertion of the wedge between the connectors or after. A power switch closes the circuit with the battery to initiate the heating cycle of the heating wedge. The trigger mechanism may be configured in any number of ways; in this case however, the following mechanism Is described: The tugger extends into the body of the C~clamp, wheretn, it is secured to the sides of the clamp body with a handle pin (133). The pin forms a fulcrum where pulling on the trigger on one side (73) of the pin (133) counterclockwise towards the handle (72), will Illicit an equivalent and opposite rotation of the trigger link (135) segment. The distance moved by the trigger link (135) will depend on its distance from the pin (133} and the degree of rotation of the trigger (73). The trigger link segment (135) is connected to a second link segment, link 2 (136), with a second pin, (pin 2), (137) through both segments, as shown in Fig 14, Pin 2, is anchored to either trigger link or link 2, not both: thereby, link 2 can rotate relative to trigger link (135). At the forward end of link 2 (136), the segment is connected to the end of the rail-bar (84) with a pin, pin 3, (138) through both parts, being anchored in one of the parts. Thus, pulling on a trigger (73) will advance the trigger link (135). Link 2 (136) between the trigger link (136)) and the rail-bar (84) transmits the trigger's movement to the rail-bar (84). Link 2 ability to rotation or swivel at both pinned ends allows conversion of the trigger “rotational” movement io the linear movement of the Rail-bar. A spring (139) attached, at one end, by a hook bote (140) at the back of Link 2; and at its other end the spring (139) is anchored to a second hook hole at (141) the back of the C-clamp. Puli of the trigger (73), as above, advances the rail-bars forward; it will also expand the spring (139) by the same distance. The expanded spring stores sufficient energy to return the trigger and mid-bar to their original position, its obvious, however, that the spring attachments need not be as describes; similar resuits may be achieved if its attached at one end directly to the trigger link (135) or to the rail-bar (84). in any case, when the trigger is cocked and the rail-bar advances, the spring will be extended and energized, its also clear that the length and shape of link 2 and the spring specifications may be set to provide the optimum travel distance of the rail-bar and control its precise return . it's desirable that the heating wedge (83) is heated prior to its insertion between the connectors. The desired temperature between the connectors is a parameter determined by the user. Typically, however, that temperature and the length of time it is applied will be such to assures inactivation of microorganisms at the interface between the connectors. The duration of the temperature ramp up is also a parameter determined by the user, based on the needed to achieve desired inactivating results. The temperature selected and the duration required to reach that temperature must aiso take into account the physical properties and limitations of the components. Ail of which must be taken into consideration when setting the heating parameters, A control devine may be used to select and adjust the selected parameters and Indicate their status. The control device may be manual in nature or fully automated. It may include a temperature sensor io indicate heating wedge temperature, its ramp up/down profile. Thus, when “working” temperature of the heating wedge is achieved, it may be indicated on a display or with LED(s) to indicate that status: at which point, the user may pull on trigger (73) to advance the heating wedge (83) between the joined connectors. One may select control parameters that allow the heating wedge to linger between the connectors to assure that desired temperatures has been achieved in the area. The heated wedge (83), at the appropriate temperature, not only sanitizes itself, but also serves as a sanitary shield against intrusion of contaminants. Precalibration of the heating cycle may be used to determine the time required to achieve the required temperatures.
A switch (145), automated or manual, may be used to activate current flow to the heating wedge (83) dining or prior io the wedge’s insertion between the connectors. Once the heating wedge (83) is activated and advanced into the connectors, the heating wedge remains in that position for the duration of the connector exchange process.
There are a number of ways a skilled person may configure a mechanism to lock- in or remove the heating wedge from between the connectors. The following describes one such mechanism (Figs. 13, 14): When the forward end of the raii-bar and the heating wedge are advanced maximally towards and into the connectors interface, a "stop” mechanism is used to limit that advance. A pin (119) through a track (121) of specified length in the rail-bars sets that stop limit The pin (119) itself is anchored to the body of the C- clamp. The rail-bar however can be advanced forward by pulling on the trigger (73) or retracted with spring (139), as previously described. In either case the travel of the rail bar is limited by pin (119) butting ragainst the side walls of track (121). Another mechanism to limit the travel of the ail-bar may be achieved as follows: The rail bar is set to such a length that when It is advanced maximally into the conneotom, the back of the rail bar (84) becomes exposed; that exposed back end (153) of the rail bar allows a peg or a "stop” (150) to drop into a gap or "step" (143) created by the advanced rail bar back end (153): a stop (142) at the rear of the rail bar prevents its retraction to the original position. , The stop itself is “T” shaped device with a short center leg (146). A pin 4 (147) through the body of the C-clamp and the said short leg (146), allowing the “top” of the “T” to rock. The top side of the TT that is more distant from the rail bar or "back T arm" (148) sits on a bail spring (151) which forces that arm "up": this, in torn, forces the stop "forward T arm” (149), "down". Therefore, when the trigger (73) is in the "un-oocked" position and the rail-bar (84) is fully retracted, the forward part of ths 1" arm (149) is riding on and pressing down on the top (152) of the rail -bar (84), (on a surface that is smooth and which doesn't hinder the movement of the rail bar). When the trigger (73) is cocked, or pulled back towards the handle, and the rail -bar is fully advanced between the connectors, a notch in the Rail bar itself or its hack (153) is presented to the front edge (150) of the forward T arm (149). (note: The back end of the rail bar (84) may serve the purpose of a notch). The forward edge (150) of the forward T arm engages and descends into the notch or back end of the mil bar. This is facilitated by the upward push of spring (151), which also "locks" the rail bar in its extended position. In a similar manner, pressing on the stop of the back T arm (148) to overcome the spring (151) upward force, lifts the forward arm (149) to disengage It from the notch or back end of the push bar. The rail bar is than free to retract and Is pulled back with the force of spring (139); that reversed movement also reverses the cocked position of the trigger (73) causing it to advance forward to the un-cocked position. While the advance of the rail bar ;s achieved by cocking the trigger, the retraction of the rail bar is achieved by the retraction of the extended spring (139). Pressing on the back T arm (148) not only disengages the ail bar from the step, as described, but It may also be used to deactivate a switch that maintair:S the power to the heating system of the 0-clamp.
An additional feature of the C-olamp is its control program; for example, it may be beneficial that the duration of heating of the connector proximal face is maintained for an optimal period before removing one of the connectors and adding a replacement connector, A temperature sensor or a timer may be used to monitor that preferred temperature, It may be desirable that such parameter are monitored and controlled.