Apparatus and method for sterile connections

Abstract

The sterile connection device includes two carriages configured to receive two tubes to be joined. A motor moves one carriage through a first portion of a path from an initial position where the tubes are heated to an intermediate position. At the point of this movement, the heated portion of each tube is below its melting point, and this movement severs the tubes and, if necessary, moves the heating element of the carriage from a retracted state to an deployed state. The movement of the carriage is stopped at the intermediate position and the cut ends of the tubes are heated to a molten state by the heating element. Movement of the carriage then continues through a second portion of the path to a final position where the heating element is retracted (if necessary) to expose the cut ends of the joined tubes.

Description

[Technical field]

[0001] [Related Applications] This application claims the benefit of and priority to U.S. Provisional Patent Application No. 63 / 313,046, filed February 23, 2022, and U.S. Provisional Patent Application No. 63 / 322,716, filed March 23, 2022, the contents of which are incorporated by reference herein.

[0002] [Technical field] The present invention relates to joining tubing, and more particularly to systems and methods for aseptically joining tubing. [Background technology]

[0003] Pre-sterilized and / or pre-assembled fluid flow systems or assemblies are used in a variety of medical and non-medical applications. Medical applications include, for example, administering medical fluids to a patient for therapeutic and / or diagnostic purposes, collection or processing of blood and / or blood components or other cells, dialysis, and other medical procedures. Non-medical applications of such systems or assemblies include, for example, pharmaceutical manufacturing and cell processing. Particularly in the medical field, such flow systems typically employ one or more pre-filled containers or other sources of medical fluids or drugs and associated fluid flow circuits or systems (sometimes referred to as tubing sets) that include the necessary flow tubes, valves, flow controls, processing chambers, etc., to perform a particular procedure, either alone or in conjunction with reusable controls or other devices. For example, it is not uncommon for medical fluid flow systems to include or be used in conjunction with containers of appropriate drugs, saline, anticoagulants, dextrose solutions, sterile water, cell preservatives, etc.

[0004] However, such fluid flow systems may pose manufacturing or assembly challenges for a variety of reasons. One reason is that containers pre-filled with medical liquids, powders, or other agents to be administered to a patient or used in a medical fluid flow system may require different sterilization techniques than the rest of the fluid flow system. For example, empty plastic tubes, containers, flow control devices, and / or processing equipment or chambers that do not contain significant amounts of liquids or other substances may be sterilized with gamma or electron beam (e-beam) radiation or by exposure to a sterilizing gas such as ethylene oxide. However, gas sterilization is not effective for sterilizing agents such as liquids, powders, or agents that are contained in sealed containers, and exposing the agents to ionizing radiation may degrade or adversely affect the agents. There may also be situations in which different parts of a sterile fluid flow system are manufactured and sterilized separately for other reasons, and then assembled under sterile conditions, despite being suitable for the same sterilization process.

[0005] Additionally, sterile connections often need to be made on-site by the end user; for example, where the fluid flow system is being used to treat a patient, collect or process blood or blood components, biological materials, or other therapeutic or diagnostic procedures. As a result, a variety of approaches have been used to assemble sterile fluid flow systems. For example, one technique for producing such systems is to use a sterile docking system, such as the device disclosed in U.S. Pat. No. 4,157,723, which is incorporated herein by reference. As shown in the figure, the sterile docking system is comprised of a pair of mating members, each with an opposing membrane. One of the mating members is connected to a pre-sterilized container of liquid, drug, or other agent, and the other mating member is attached to a pre-sterilized fluid flow system, which may include one or more empty containers. After the two members are mated, the docking system is exposed to radiant energy, which melts the membrane and creates a sterile fluid pathway through the mating members. The fluid is then transferred from the first container to an empty container in the fluid flow system, sealing and cutting the flow path. The first container and mating members are then discarded. This works well, but requires multiple manufacturing steps to transfer the solution from one container to another under sterile conditions, as well as the quality control steps associated with such steps, and requires that some of the product be discarded, increasing product and waste costs.

[0006] An alternative approach, described in U.S. Patent No. 4,978,446 (incorporated herein by reference), uses a sterile filter on an inlet flow line that couples a pre-sterilized liquid container or the like to a separately sterilized fluid-flow tubing system. This method requires a medical professional to manually connect the fluid-flow tubing system to the fluid container, such as by piercing the fluid container with a piercing member associated with the fluid-flow system. In addition to the administrative requirements for separately ordering, storing, and prescribing solutions and disposable flow systems or sets, there is also an increased opportunity for error by connecting the wrong liquid or other drug container or using an inappropriate flow system in connection with a procedure.

[0007] Devices commonly referred to as sterile tubing welders are also known, such as the device sold by Terumo Medical Corporation as the TSCD-II sterile tubing welder. This device uses a heated cutting element to slice and melt the ends of the tubing, then joins the tubing after the cutting element is removed. Aspects of this device are disclosed in U.S. Patent Application Publication No. 2020 / 0047423, which is incorporated herein by reference. One notable drawback of such devices is the requirement for the use of expensive cutting elements (each of which consists of a resistive circuit layer sandwiched between two copper layers) that are replaced for each connection.

[0008] JP 09-206383 A (herein incorporated by reference) describes an apparatus that replaces disposable cutting elements with reusable cutting elements. The reusable cutting element only partially cuts the walls of a pair of tubes to be joined, rather than completely cutting the tubes to be joined. One tube holder of the apparatus moves in an arc relative to another tube holder, tearing apart the partially cut portion of the tube. At the end of the arc movement, the torn ends of the two tubes are forced together, forming a joint and completing one joined tube. Because the cutting element does not pass through or is inserted into the lumens of the tubes to be joined, the cutting element does not contaminate the fluid flow path defined by the lumens, and the cutting element can be reused, rather than being discarded after a single use.

[0009] Recent devices improve upon older devices that required disposable cutting elements, but further improvements are possible. For example, certain devices require multiple heating techniques to join a pair of tubes, such as applying radio frequency energy when sealing and cutting the ends of the pair of tubes to be joined, and then applying radiant heat when joining the cut ends. Certain devices require multiple motors to move the components of the device in different directions. Devices that tear or pull apart the uncut ends of a pair of tubes heat the ends of the tubes to a high enough temperature that threads or fibers may form as the fused ends of the tubes are torn or pulled apart, and then when the tubes are joined, threads or fibers "F" remain as shown in Figure 1.

[0010] The sterile connection apparatus and method according to the present disclosure addresses these and other shortcomings of known devices. Summary of the Invention

[0011] The subject matter of the present invention has several aspects that may be embodied individually or together in the devices, systems, and methods described and / or claimed below. These aspects may be used alone or in combination with other aspects of the subject matter described herein, and describing these aspects together is not intended to preclude using these aspects separately or claiming these aspects separately or in different combinations as described in the claims appended hereto or as later amended.

[0012] The following summary is intended to generally inform the reader of various potential aspects of the present subject matter and is not intended to be limiting or exclusive with respect to the various possible aspects or combinations of aspects. For additional aspects and features, see the detailed description herein and / or the accompanying figures.

[0013] In one aspect, the sterile connection device includes a first carriage, a second carriage, and a motor. The first carriage includes a mandible defining a first portion of a proximal slot configured to accommodate a portion of a proximal tube and a first portion of a distal slot configured to accommodate a portion of a distal tube. The upper jaw of the first carriage is configured to move between an open state away from the mandible and a closed state disposed adjacent to the mandible. The second carriage is disposed laterally of the first carriage and includes a mandible defining a second portion of a proximal slot and a second portion of a distal slot. The second carriage has an upper jaw configured to move between an open state away from the mandible and a closed state disposed adjacent to the mandible. The motor is configured to move the second carriage from an initial position to a final position. In the initial position, the first and second portions of the proximal slot are aligned and the first and second portions of the distal slot are aligned, and in the final position, one of the first and second portions of the proximal slot is aligned with one of the first and second portions of the distal slot. The sterile connection apparatus does not include any motors other than the single motor used to move the second carriage.

[0014] In another aspect, a sterile connection apparatus includes a first carriage, a second carriage, and a motor. The first carriage includes a lower jaw defining a first portion of a proximal slot configured to accommodate a portion of a proximal tube and a first portion of a distal slot configured to accommodate a portion of a distal tube. The upper jaw of the first carriage is configured to move between an open state away from the lower jaw and a closed state disposed adjacent to the lower jaw. The second carriage is disposed laterally of the first carriage and includes a lower jaw defining a second portion of a proximal slot and a second portion of a distal slot. The upper jaw of the second carriage is configured to move between an open state away from the lower jaw and a closed state disposed adjacent to the lower jaw. The motor is configured to move at least one carriage from an initial position to a final position. In the initial position, the first and second portions of the proximal slot are aligned and the first and second portions of the distal slot are aligned, and in the final position, one of the first and second portions of the proximal slot is aligned with one of the first and second portions of the distal slot. Each carriage includes a waste end heating element associated with one of the first and second portions of the slot defined by that carriage and a coupled heating element associated with the same or a portion of the other slot defined by the carriage. Each waste end heating element is configured to operate in the initial position and each coupled heating element is configured to operate when the moveable carriage is not in either the initial or final position.

[0015] In yet another aspect, a sterile connection device includes a first carriage, a second carriage, and a motor. The first carriage includes a mandible defining a first portion of a proximal slot configured to accommodate a portion of a proximal tube and a first portion of a distal slot configured to accommodate a portion of a distal tube. The upper jaw of the first carriage is configured to move between an open state away from the mandible and a closed state disposed adjacent to the mandible. The second carriage is disposed laterally of the first carriage and includes a mandible defining a second portion of a proximal slot and a second portion of a distal slot. The upper jaw of the second carriage is configured to move between an open state away from the mandible and a closed state disposed adjacent to the mandible. The motor is configured to move at least one carriage from an initial position to an intermediate position to a final position. In the initial position, the first and second portions of the proximal slot are aligned and the first and second portions of the distal slot are aligned, and a portion of each tube is heated. Moving the moveable carriage from the initial position to the intermediate position causes the heated portion of each tube to tear, defining a torn end. The heated portion of each tube is torn while at a first temperature below its melting point. In the intermediate position, the torn end of each tube is heated to a second temperature above the melting point of the torn end. In the final position, one of the first and second portions of the proximal slot aligns with one of the first and second portions of the distal slot, and the torn ends of the tubes are aligned and joined.

[0016] In another embodiment, a method of sterilely connecting two tubes includes heating a portion of each of two tubes and then cutting each tube at the heated portion to define a cut end of each tube. The cut ends of the two tubes are brought into contact with each other and the tubes are heated and joined without the application of any type of energy other than radio frequency energy.

[0017] These and other aspects of the present subject matter are described in the following detailed description of the accompanying drawings. [Brief description of the drawings]

[0018] FIG. 1 is a detailed view of a portion of a junction tube formed by a sterile connecting device constructed according to a conventional design.

[0019] FIG. 2 is a perspective view of a sterile connection device according to one embodiment of the present invention, showing the movable carriage in an initial position.

[0020] FIG. 3 is a top view of the sterile connection apparatus of FIG. 2, including a pair of tubes received by a movable carriage of the sterile connection apparatus and a fixed carriage.

[0021] FIG. 4 is a top view of the sterile connection device and tubing of FIG. 3 with the upper jaw of the carriage in a closed position.

[0022] FIG. 5 is a side view of the fixed carriage of the sterile connection apparatus of FIGS. 2-4 facing the moveable carriage, with the associated heating elements in a deployed position.

[0023] 6 is a side perspective view of the stationary carriage of FIG. 5. FIG.

[0024] FIG. 7 is a side perspective view of the stationary carriage of FIGS. 5 and 6 with the upper electrodes of its associated heating elements in a retracted position.

[0025] FIG. 8 is a schematic diagram of the carriage of the sterile connection device of FIGS. 2 to 4, showing the movable carriage in an initial position.

[0026] FIG. 9 is a schematic diagram of the carriage of the sterile connection apparatus of FIGS. 2-4, showing the moveable carriage in an intermediate position.

[0027] FIG. 10 is a schematic diagram of the carriage of the sterile connection apparatus of FIGS. 2-4, showing the moveable carriage in a final position.

[0028] FIG. 11 is a top view of the sterile connection apparatus of FIGS. 2-4 with the movable carriage in a final position and the upper jaw of the carriage in a closed position.

[0029] FIG. 12 is a top view of the sterile connection apparatus of FIGS. 2-4 with the movable carriage in a final position and the upper jaw of the carriage open.

[0030] FIG. 13 is a detailed view of a joined tubing joint formed by a sterile connecting apparatus constructed in accordance with the present disclosure.

[0031] FIG. 14 is a perspective view of another embodiment of a sterile connection device according to an aspect of the present invention, showing the moveable carriage in an initial position.

[0032] FIG. 15 is a schematic diagram of the carriage of the sterile connection apparatus of FIG. 14, showing the moveable carriage in an initial position.

[0033] 16 and 17 are schematic diagrams of the carriage of the sterile connection apparatus of FIG. 14 with the movable carriage in an intermediate position.

[0034] FIG. 18 is a schematic diagram of the carriage of the sterile connection apparatus of FIG. 14, showing the moveable carriage in a final position. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0035] The embodiments disclosed herein are intended to be illustrative of the subject matter of the present invention, and it is understood that the subject matter of the present invention can be embodied in various other forms and combinations not specifically shown, and therefore the specific designs and features disclosed herein should not be construed as limiting the subject matter defined in the appended claims.

[0036] 2-12 illustrate an exemplary embodiment of a sterile connection apparatus 10 according to one aspect of the present disclosure. Although the sterile connection apparatus according to the present disclosure is particularly suited for the sterile connection of tubing formed from plasticized polyvinyl chloride, it is within the scope of the present disclosure to use the sterile connection apparatus 10 for the sterile connection of tubing formed from other materials.

[0037] The illustrated sterile connection device 10 includes a housing 12 that houses various components of the sterile connection device 10 (e.g., a control, one or more power sources, a thermocouple, etc.). The housing 12 may be of a variety of configurations without departing from the scope of the invention, including, for example, a housing 12 having different portions formed from a metal material, a plastic material, or a combination of metal and plastic materials.

[0038] In the illustrated embodiment, the first carriage 14 and the second carriage 16 are associated with an upper surface or face of the housing 12, with the second carriage 16 disposed laterally of the first carriage 14. During a sterile connection procedure to join together the two tubes "P" and "D" (FIGS. 3 and 4), at least a portion of at least one of the carriages 14, 16 is movable relative to the housing 12. In one embodiment described in more detail herein, the first carriage 14 is fixed relative to the remainder of the housing 12, and the second carriage 16 is movable relative to the first carriage 14.

[0039] The first carriage 14 includes an upper jaw 18 and a lower jaw 20, with the upper jaw 18 being movable between an open (FIGS. 2 and 3) and a closed (FIG. 4) position. While the upper jaw 18 in the illustrated embodiment is pivotable between the open and closed positions, it should be understood that the upper jaw 18 may be otherwise movable (e.g., by vertical movement) between the open and closed positions without departing from the scope of the present disclosure.

[0040] When the upper jaw 18 is in the open position, the lower jaw 20 is exposed or uncovered, allowing a pair of tubes P and D to be installed in the first carriage 14 (at the beginning of a sterile connection procedure) and a coupled tube "J" (FIGS. 12 and 13) to be removed from the first carriage 14 (at the end of a sterile connection procedure). The lower jaw 20 of the first carriage 14 defines a first portion 22a of a proximal slot 22 and a first portion 24a of a distal slot 24 that is parallel to the first portion 22a of the proximal slot 22 (FIG. 2). In the illustrated embodiment, the first portion 22a of the proximal slot 22 and the first portion 24a of the distal slot 24 are substantially identical, but it should be understood that they may be configured differently without departing from the scope of the present disclosure. Regardless of the exact configuration, each of the first portions 22a, 24a is sized and configured to accommodate a portion of a tube coupled to a tube received by the other slot 22, 24. This may include each first portion 22a, 24a having a generally arcuate or V-shaped profile to facilitate proper positioning (i.e., centering) of the tube inserted into the slots 22, 24.

[0041] When the upper jaw 18 of the first carriage 14 is in a closed condition (FIG. 4), the upper jaw 18 covers or rests over the tubing housed within the slots 22 and 24 to hold the tubing in place during a sterile connection procedure. The illustrated upper jaw 18 includes a latch 26 configured to engage a pin 28 of the lower jaw 20 when the upper jaw 18 is in a closed condition. Such an arrangement prevents inadvertent movement of the upper jaw 18 from a closed condition to an open condition, although it should be understood that other locking arrangements (e.g., a magnetic interlock) may be employed without departing from the scope of the present disclosure.

[0042] The second carriage 16 is configured similarly to the first carriage 14, with the upper jaw 30 being configured in accordance with the previously described description of the upper jaw 18 of the first carriage 14, and the lower jaw 32 being configured in accordance with the previously described description of the lower jaw 20 of the first carriage 14.

[0043] As will be described in more detail, the second carriage 16 may be configured to move relative to the first carriage 14 (and housing 12), but in an initial or default position, the second carriage 16 is positioned such that the second portion 22b of the proximal slot 22 (defined by the lower jaw 32 of the second carriage 16) is aligned with the first portion 22a of the proximal slot 22 and the second portion 24b of the distal slot 24 (defined by the lower jaw 32 of the second carriage 16) is aligned with the first portion 24a of the distal slot 24. With the second carriage 16 in such initial or default position (and the upper jaws 18 and 30 in an open position), the proximal tube P can be inserted into the proximal slot 22, where the proximal tube P is partially received by a first portion 22a of the proximal slot 22 (defined by the lower jaw 20 of the first carriage 14) and partially received by a second portion 22b of the proximal slot 22 (defined by the lower jaw 32 of the second carriage 16).

[0044] Similarly, distal tube D can be inserted into distal slot 24, with proximal tube P being partially received by first portion 24a of distal slot 24 (defined by mandible 20 of first carriage 14) and partially received by second portion 24b of distal slot 24 (defined by mandible 32 of second carriage 16). While conventional sterile connection devices may require each tube to be connected to be at least 31 mm in length, a sterile connection device according to the present disclosure is capable of connecting shorter tubes, including tubes as long as about 22 mm.

[0045] The proximal tube P and the distal tube D are mounted in opposite orientation on the sterile connection apparatus 10, with one end of the tubes P, D positioned closer to the first carriage 14 and the other end of the tubes P, D positioned closer to the second carriage 16. To that end, a top surface or upper face of the housing 12 may be provided with indicia to indicate the position and orientation of the tubes P and D to be placed at the start of a sterile connection procedure.

[0046] Each portion of each slot 22,24 has a heating element associated therewith, as best shown in Figures 5-10. The portion of each slot 22,24 of each carriage 14,16 has a waste end heating element 34 associated therewith, and the portion of the other slot 22,24 defined by that carriage 14,16 has a combined heating element 36 associated therewith. The heating elements 34,36 are disposed on the side of each carriage 14,16 facing the other carriage 14,16, and when the carriages 14 and 16 are in the initial position, each slot 22,24 has one waste end heating element 34 disposed adjacent to the combined heating element 36 (Figure 8). The individual heating elements may be variously configured without departing from the scope of this disclosure. However, in one embodiment, each heating element 34, 36 is configured as a pair of electrodes, with one upper electrode "U" associated with or incorporated into an upper jaw of a carriage and the other lower electrode "L" associated with or incorporated into a lower jaw of the same carriage (FIGS. 5-7). In such an embodiment, the electrodes may be formed of any of a variety of suitable materials, which may vary depending on the manner in which tubes P and D are to be heated. For example, if radio frequency ("RF") energy is used to heat tubes P and D, the electrodes may be formed of a metal (or combination of metals) with high electrical conductivity, such as stainless steel, brass, titanium, or the like.

[0047] As will be described in more detail below, the waste end heating element 34 functions to heat a portion of the tube in preparation for removal of the end of the tube as waste from the remainder of the tube (hence the term "waste end" used to identify these heating elements). In the illustrated embodiment, as shown in Figures 11 and 12, the "waste end" W of the proximal tube P is disposed adjacent the first carriage 14 and the "waste end" W of the distal tube D is disposed adjacent the second carriage 16. Thus, as best shown in Figures 8-10, a first portion 22a of the proximal slot 22 (which receives the "waste end" W of the proximal tube P) is provided with a waste end heating element 34, and a second portion 24b of the distal slot 24 (which receives the "waste end" W of the distal tube D) is provided with a waste end heating element 34. 5 shows the side of the first carriage 14 facing the second carriage 16, with the first portion 22a of the proximal slot 22 provided with a waste end heating element 34 consisting of a lower electrode L incorporated in the lower jaw 20 and a corresponding upper electrode U incorporated in the upper jaw 18. It should be appreciated that the second portion 24b of the distal slot 24 may similarly include a waste end heating element 34 consisting of a lower electrode L incorporated in the lower jaw 32 of the second carriage 16 and an upper electrode U incorporated in the upper jaw 30 of the second carriage 16.

[0048] As discussed above, each slot 22, 24 has one waste end heating element 34 and one coupled heating element 36. Thus, in the illustrated embodiment, a coupled heating element 36 is associated with or incorporated into the second portion 22b of the proximal slot 22, and another coupled heating element 36 is associated with or incorporated into the first portion 24a of the distal slot 24. FIGS. 5-7 show how the first portion 24a of the distal slot 24 has a coupled heating element 36 comprised of a lower electrode L incorporated into the lower jaw 20 of the first carriage 14 and a corresponding upper electrode U incorporated into the upper jaw 18. It should be understood that the second portion 22b of the proximal slot 22 may similarly include a coupled heating element 36 comprised of a lower electrode L incorporated into the lower jaw 32 of the second carriage 16 and an upper electrode U incorporated into the upper jaw 30 of the second carriage 16. As will be described in more detail, the bonding heating elements 36 function to heat portions of tubes P and D (particularly the ends of the tubes remaining after removal of the "waste ends" W) in preparation for joining tubes P and D (hence the term "bonding" is used to identify these heating elements).

[0049] Each heating element 34, 36 is coupled to an energy source that is activated to heat the portion of the tube disposed adjacent the heating element 34, 36. The nature of the energy source may vary without departing from the scope of the present disclosure. However, according to one embodiment, each heating element 34, 36 is coupled to an energy source 38 (FIGS. 8-10) configured as an RF energy source that is activated to heat the tube P, D with which the heating element 34, 36 is associated (the heating element itself is not heated). In such an embodiment, the relative simplicity in which only RF energy is used to sever and then join tubes P and D may be advantageous compared to prior devices that require multiple forms of energy (e.g., RF energy and radiant heat) to sever and join a pair of tubes. In other embodiments, the energy source of the waste end heating element 34 may be different from the energy source of the joining heating element 36. For example, one type of heating element (either waste end heating element 34 or combined heating element 36) may be associated with an RF energy source and the other type of heating element may be associated with an energy source that includes a laser (in which case tubes P and D are heated by laser heating) or an energy source configured such that the associated heating element applies radiant heat to tubes P and D.

[0050] As discussed above, one or both of the carriages 14 and 16 may be movable relative to the other carriages 14, 16 (and relative to the housing 12 of the sterile connection apparatus 10). While it is within the scope of the present disclosure for both carriages 14 and 16 to be movable, in an exemplary embodiment, only the second carriage 16 is movable. In such an embodiment, the motor 40 (FIGS. 8-10) is configured to operate to move the second carriage 16 relative to the first carriage 14 (and relative to the housing 12). Although operation of the motor 40 is described herein as moving the second carriage 16, it should be understood that the motor 40 may be configured to move components of the sterile connection apparatus 10 that are fixed to or associated with the second carriage 16, and that the second carriage 16 may be moved along with other components. For example, in the illustrated embodiment, the second carriage 16 is mounted on a plate or platform 42 which functions as a bidirectional parallel guide, facilitating free translational movement in the plane of the plate or platform 42 while preventing changes in the angular orientation of the second carriage 16.

[0051] In any event, the motor 40 moves the second carriage 16 from an initial position (FIG. 8) through one or more intermediate positions (FIG. 9) to a final position (FIG. 10). FIGS. 8-10 show the second carriage 16 moving through a substantially semicircular arcuate path, with the second carriage 16 moving along a first portion of the arcuate path from the initial position (FIG. 8) to the intermediate position (FIG. 9) and the second carriage 16 moving along a second portion of the arcuate path from the intermediate position to the final position (FIG. 10). In such an embodiment, the second carriage 16 may be coupled (directly or indirectly) to the motor 40, such as by an eccentric shaft 44 configured to translate operation of the motor 40 into movement of the second carriage 16 through the arcuate path. Regardless of the particular coupling between the motor 40 and the second carriage 16, the motor 40 may be configured to operate in a first direction, or forward direction, to move the second carriage 16 from an initial position to a final position, and the motor 40 may be configured to operate in a second direction, i.e., an opposite or reverse direction, to move the second carriage 16 from the final position back to the initial position. In another embodiment, the drive assembly may be configured such that operating the motor 40 in one direction causes the second carriage 16 to move alternately between the initial position and the final position.

[0052] 8-10 show the second carriage 16 moving along an approximately 90° arc from an initial position to an intermediate position, and then moving along another 90° arc from the intermediate position to a final position (completing a 180° movement along a roughly semicircular path). However, it should be noted that the portions of the path traversed by the second carriage 16 as it moves from the initial position to the intermediate position and as it moves from the intermediate position to the final position may be different. For example, the motor 40 may be actuated to move the second carriage 16 along a 30° arc, and then the motor 40 may be actuated again to move the second carriage 16 along a 150° arc from the intermediate position to the final position. As will be described in more detail, because the coupled heating element 36 is configured to heat the cut ends of tubes P and D when the second carriage 16 is in the intermediate position, an intermediate position sufficiently distant from the initial position may be advantageous so that the “waste ends” W of tubes P and D have been removed by the time the second carriage 16 reaches the intermediate position.

[0053] While FIGS. 8-10 depict a generally semicircular, arcuate path, it should be understood that the second carriage 16 may be moved through any path from the initial position to the final position without departing from the scope of the present disclosure. This may include the second carriage 16 being moved along a relatively simple path (e.g., a straight path or a curved path other than a semicircle), or along a more complex or irregular path. A relatively simple path (compared to a more complex path) may be advantageous in that a single motor may be sufficient to control the movement of the second carriage 16 throughout the path. On the other hand, a more complex or irregular path (which may require multiple motors to control the movement of the second carriage 16 along the path) may be advantageous or even necessary in some cases (e.g., where the second carriage 16 needs to be moved in a first direction by a first motor to perform one stage of a sterile connection procedure and in a second direction by a second motor to perform another stage of the procedure).

[0054] As discussed above, the sterile connecting apparatus 10 includes a controller, which may be of various configurations without departing from the scope of the present disclosure, so long as the controller is configured to coordinate the various tasks performed by the components of the sterile connecting apparatus 10 during the sterile connecting procedure. In one embodiment, the controller may include a microprocessor (which may in fact include multiple physical and / or virtual processors). According to other embodiments, the controller may include one or more electrical circuits designed to perform the operations described herein. In fact, the controller may include a microprocessor or other circuits or circuitry. Additionally, the controller may include one or more memories. Instructions to program the microprocessor may be stored in a memory associated with the microprocessor, which memory / memories may include one or more tangible, non-transitory, computer readable memories having computer executable instructions stored therein that, when executed by the microprocessor, enable the microprocessor to perform one or more of the actions described herein.

[0055] Now describing an exemplary sterile connection procedure, with upper jaws 18 and 30 open (see FIG. 2), an operator places two tubes P and D into proximal and distal slots 22 and 24 defined by lower jaws 20 and 32 of carriages 14 and 16. As shown in FIG. 3, the end of proximal tube P (which will be the "waste end" W) is positioned adjacent to the first carriage 14 and the end of distal tube D (which will be the "waste end" W) is positioned adjacent to the second carriage 16. It should be understood that this orientation of tubes P and D is merely exemplary and the orientation may be reversed (with the "waste end" W of proximal tube P positioned adjacent to the second carriage 16 and the "waste end" W of distal tube D positioned adjacent to the first carriage 14). In that case, heating element 34 and heating element 36 are appropriately positioned (i.e., waste end heating element 34 is associated with portions of slot 22 and slot 24 configured to receive the “waste ends” W of tubes P and D).

[0056] With tubes P and D in place, the operator moves upper jaws 18 and 30 from an open to a closed position (FIG. 4). Upper jaws 18 and 30 may be independently movable between the open and closed positions, or may be configured to move together from an open position to a closed position and / or from a closed position to an open position. As described above, in the closed position, upper jaws 18 and 30 cover lower jaws 20 and 32, securing tubes P and D within carriages 14 and 16.

[0057] With upper jaw 18 and upper jaw 30 closed, the operator presses the "start" button to continue the sterile connection procedure. Pressing the "start" button causes the controller to activate the energy source 38 coupled to waste end heating element 34, which causes the waste end heating element 34 to heat tubes P and D to the desired temperature. The exact temperature to which tubes P and D are heated by waste end heating element 34 may vary without departing from the scope of this disclosure. In one embodiment, tubes P and D are heated to a temperature below the melting point of the material from which tubes P and D are formed. A similar effect can be achieved by heating tubes P and D to a temperature at or above their melting point and then cooling tubes P and D to a temperature below their melting point. In either case, such an approach prevents tubes P and D from being melted by waste end heating element 34, which prevents threads or fibers from forming when the "waste ends" W of tubes P and D are later removed (discussed below).

[0058] Once tubes P and D reach the target temperature (e.g., as determined by a controller based on signals received from a thermocouple or the like), motor 40 is actuated to move second carriage 16 from the initial position (FIGS. 4 and 8) to the intermediate position (FIG. 9). Waste end heating element 34 can be deactivated at any suitable time, such as when tubes P and D reach the target temperature or when motor 40 is actuated to move second carriage 16 from the initial position. In one embodiment, waste end heating element 34 is configured to continue to heat tubes P and D after second carriage 16 has been moved from its initial position.

[0059] Tubes P and D are secured within carriages 14 and 16, and as second carriage 16 moves away from first carriage 14, tubes P and D are placed under tension. As second carriage 16 continues to move from the initial position toward the intermediate position, tension on tubes P and D increases, causing tubes P and D to be pulled apart or severed at the portions heated by waste end heating elements 34, removing the "waste ends" W of tubes P and D, respectively, leaving the cut ends exposed in the bodies of each tube P, D. Because tubes P and D are "cold" (i.e., not molten) at the time they are torn apart, no threads or fibers are formed when the "waste ends" W are removed, and therefore no threads or fibers remain when the cut ends of tubes P and D are later joined (compare the conventional joint of FIG. 1 with the joint formed in accordance with the present disclosure shown in FIG. 13).

[0060] In addition to applying tension to tubes P and D, movement of second carriage 16 away from first carriage 14 causes each of coupled heating elements 36 to move from a retracted state (FIGS. 7 and 8) to a deployed state (FIGS. 5, 6 and 9). The mechanism by which coupled heating elements 36 move from the retracted state to the deployed state may be varied without departing from the scope of this disclosure. In the exemplary embodiment, the movement is automatic and passive, and does not require the actuation of a motor or other electromechanical driving force. In the illustrated embodiment, each coupled heating element 36 includes an associated bumper 46 (FIGS. 5-7) that is configured to move with the associated coupled heating element 36 between the retracted and deployed states. When each coupled heating element 36 includes a pair of electrodes U and L (as in the illustrated embodiment), each electrode U, L of the coupled heating element 36 may have a respective associated bumper 46.

[0061] Each bumper 46 is biased (e.g., by an associated spring or similar resilient element) to the deployed state, but is positioned such that the bumper 46 contacts the opposite carriage 14, 16 when the second carriage 16 is in the initial and final positions, thereby holding the bumper 46 (and associated associated heating element 36) in the retracted state. Thus, as the second carriage 16 is moved away from the initial position (away from the first carriage 14), the bumper 46 automatically and passively begins to move from the retracted state to the deployed state. The bumpers 46 and associated biasing mechanism are configured such that the bumper 46 and associated heating element 36 move to the deployed state by the time the second carriage 16 reaches the intermediate position (FIG. 9).

[0062] When the second carriage 16 reaches the intermediate position, the motor 40 is temporarily stopped to hold the second carriage 16 in the intermediate position. The combined heating element 36 (moved to the deployed state) is activated for at least a portion of the time that the second carriage 16 is in the intermediate position to heat the cut ends of the tubes P and D to a second target temperature (e.g., determined by the controller based on signals received from a thermocouple or the like). The combined heating element 36 may be activated before the second carriage 16 reaches the intermediate position and remain activated until some time after the second carriage 16 moves from the intermediate position toward the final position. In any event, the combined heating element 36 is configured and operated to heat the cut ends of the tubes P and D to a temperature at or above the melting point of the tube material to melt or fuse the cut ends. It can thus be seen that the combined heating element 36 operates to heat the tubes P and D to a temperature higher than the temperature of the tubes when the tubes P and D are cut (after being heated by the waste end heating element 34).

[0063] To avoid electrical arcing (which can occur when heating liquid-filled tubes with RF energy), any of several possible safety measures can be employed. For example, RF current can be monitored and controlled to avoid electrical arcing. In another approach, the coupled heating element 36 can be configured to avoid local electric field strength maxima and / or be galvanically isolated. According to yet another approach, steps can be taken to move the liquid in tubes P and D away from the coupled heating element 36 (when active). In another embodiment, where application of RF energy is avoided, radiant heat is instead used by the coupled heating element 36 to heat tubes P and D (e.g., retractable electrodes are replaced with retractable heat shields).

[0064] As noted above, it is within the scope of this disclosure for the waste end heating element 34 to continue operating after the second carriage 16 is moved away from the initial position. This may include the waste end heating element 34 operating to heat the "waste ends" W of tubes P and D while the second carriage 16 is in an intermediate position, which may be advantageous to ensure that the "waste ends" W are safely sealed prior to the end of the procedure. In such an embodiment, the operation of the waste end heating element 34 and the combined heating element 36 may overlap (the combined heating element 36 begins to heat tubes P and D before the waste end heating element 34 becomes inactive), or the combined heating element 36 may remain inactive until the waste end heating element 34 becomes inactive (at which point the combined heating element 36 may be activated).

[0065] Once the controller determines that the cut ends of tubes P and D have been heated to the appropriate temperature, it commands the motor 40 to move the second carriage 16 from the intermediate position (FIG. 9) to the final position (FIGS. 10 and 11) to complete the movement of the second carriage 16. The combined heating element 36 is configured to return to the retracted state by the time the second carriage 16 reaches the final position and the (heated / melted) cut ends of tubes P and D are exposed. The mechanism for returning the combined heating element 36 from the deployed state to the retracted state may be varied without departing from the scope of this disclosure. However, in the illustrated embodiment, as the second carriage 16 moves from the intermediate position to the final position, a bumper 46 associated with the combined heating element 36 comes into contact with the opposing carriage 14, 16, automatically and passively pushing the bumper 46 (and associated combined heating element 36) back to the retracted state.

[0066] With the second carriage 16 in its final position and the bond heating element 36 in its retracted state, the cut ends of tube P and tube D are exposed, aligned, and moved into contact with one another. The cut ends of tube P and tube D are pressed together for a predetermined period of time (e.g., 7 seconds), a bond is formed, and the bond is allowed to cool. In one embodiment, the waste end heating element 34 can be activated again with the second carriage 16 in its final position to heat the "waste end" so that it is safely sealed.

[0067] Once the joint is made and cooled, the control proceeds to the next stage of the procedure. At this stage, the operator is notified that tubes P and D have been sterilely connected and that a joined tube J has been defined (FIG. 11). This notification may be provided, for example, in the form of an audio alert (such as an alarm) and / or a visual alert (such as a flashing light or an icon displayed on a screen). At this point, the control unlocks upper jaws 18 and 30 (if locked in a closed position), and the operator can return upper jaws 18 and 30 to an open position (FIG. 12), remove joined tubes J from lower jaws 20 and 32 of carriages 14 and 16 (FIG. 13), and discard the "waste ends" W of tubes P and D. The joined tubes J are then manipulated (manually or by a suitably configured device) to open the joint (e.g., by pinching the joint) to allow fluid flow and ensure that the joint is secure.

[0068] At the end of the procedure, the operator can press a "reset" button to reset the sterile connection device 10, which may include the control commanding the motor 40 to return the second carriage 16 to its initial position.

[0069] 14-18 show another exemplary embodiment of a sterile connection device 10a according to the present disclosure. The sterile connection device 10a of FIGS. 14-18 is configured similarly to the sterile connection device 10 of FIGS. 2-12 (similar components are correspondingly numbered and configured as described above unless otherwise noted), with two carriages 14 and 16 (at least one of which is movable), four heating elements 34 and 36, and multiple heating stages. However, rather than including one heating element in all four portions of the slots 22 and 24, the sterile connection device 10a of FIGS. 14-18 has two portions 22b and 24a without heating elements. The other two portions 22a and 24b have waste end heating element 34 and combined heating element 36, respectively. In accordance with the above description of the embodiments of Figures 14-18, each heating element may be variously configured without departing from the scope of the present disclosure, and each heating element 34, 36 may include an upper electrode and a lower electrode, or an upper heat shield and a lower heat shield (as shown in Figure 14).

[0070] The method of performing a sterile connection procedure using the sterile connection apparatus 10a of Figure 14 is similar to the procedure described above, with some notable differences. The procedure begins similarly with an operator placing two tubes P and D into the proximal and distal slots 22 and 24 defined by the mandibles 20 and 32 of the carriages 14 and 16 (see Figure 14). As with the procedure described above, the end of the proximal tube P (which will be the "waste end" W) is positioned adjacent the first carriage 14 and the end of the distal tube D (which will be the "waste end" W) is positioned adjacent the second carriage 16 (i.e., in the portion 22a of the slot 24b that contains the heating elements 34 and 36).

[0071] With tubes P and D in place, the operator moves upper jaws 18 and 30 from an open position to a closed position to secure tubes P and D within carriages 14 and 16 (as described above). When the operator presses the "start" button, the controller activates an energy source (not shown) coupled to waste end heating element 34, which heats tubes P and D to the desired temperature. As described above, waste end heating element 34 heats tubes P and D to a temperature below or above the melting point of the material forming tubes P and D, followed by a cooling phase in which tubes P and D cool until they reach a temperature below their melting point.

[0072] When tubes P and D reach the target temperature, a motor is actuated to move second carriage 16 from the initial position (FIG. 15) to the intermediate position (FIG. 16). Waste end heating element 34 can be deactivated at any suitable time, such as when tubes P and D reach the target temperature or when a motor is actuated to move second carriage 16 from the initial position.

[0073] Tubes P and D are secured within carriages 14 and 16, and as second carriage 16 moves away from first carriage 14, tubes P and D are placed under tension. As second carriage 16 continues to move from the initial position toward the intermediate position, the tension on tubes P and D increases until tubes P and D are pulled apart or severed, respectively, at the portions heated by waste end heating elements 34, removing the "waste ends" W of tubes P and D and leaving the cut ends exposed in the main body of each tube P, D.

[0074] Once the second carriage 16 reaches the intermediate position, the motor is temporarily stopped to hold the second carriage 16 in the intermediate position. The coupled heating elements 36 are activated for at least a portion of the time that the second carriage 16 is in the intermediate position to heat the cut ends of tubes P and D to a second target temperature (e.g., determined by the controller based on signals received from a thermocouple or the like) that is above the melting point of the tube material to melt or fuse the cut ends.

[0075] It can be seen that the intermediate position of FIG. 16 is closer to the initial position (FIG. 15) than in the procedure described above. This is because each combined heating element 36 is mounted on the same carriage as its associated waste end heating element 34. Thus, the second carriage 16 is moved a small distance from its initial position to the intermediate position to properly position the cut ends of tubes P and D relative to the combined heating element 36. While it is within the scope of this disclosure to move the sterile connection apparatus 10 of FIGS. 2-12 to an intermediate position similar to that shown in FIG. 16, a greater distance between carriages 14 and 16 may be advantageous to ensure that combined heating elements 36 are moved from the retracted state to the deployed state.

[0076] Notably, the combined heating elements 36 of the embodiment of Figures 14-18 are not movable between retracted and deployed states, but rather are stationary and fixed in position within carriages 14 and 16, such that each combined heating element 36 maintains a position adjacent to its associated waste end heating element 34 throughout the entire sterile connection procedure. Because combined heating elements 36 are not retractable and remain in a deployed state, carriages 14 and 16 may remain in relatively close proximity as combined heating elements 36 are actuated to heat the cut ends of tubes P and D. In comparison to the embodiment of Figures 2-12, the embodiment of Figures 14-18 has fewer moving parts and may be particularly robust and inexpensive.

[0077] When the control unit determines that the cut ends of tube P and tube D have been heated to the appropriate temperature, it issues a command to the motor to move second carriage 16 from the intermediate position (FIG. 16) to the final position (FIG. 18) to complete the movement of second carriage 16. FIGS. 15-18 show second carriage 16 moving through an arcuate or approximately semicircular path (FIG. 17 shows a second intermediate position between the intermediate position of FIG. 16 and the final position of FIG. 18). In this case, the movement of second carriage 16 from the initial position (FIG. 15) to the intermediate position of FIG. 16 may be a small portion of such an arcuate path. However, similar to the procedure described above, it is also within the scope of the present disclosure for second carriage 16 of sterile connection apparatus 10a to move through a non-arcuate path from its initial position to its final position.

[0078] When the second carriage 16 is in the final position (FIG. 18), the cut ends of tube P and tube D are aligned and moved into contact with one another. The cut ends of tube P and tube D are pressed together for a predetermined period of time (e.g., 7 seconds), a bond is formed, and the tubes are allowed to cool. In one embodiment, the waste end heating element 34 may be activated again with the second carriage 16 in the final position to heat the "waste ends" W and ensure they are safely sealed.

[0079] Once the connection is made and cooled, the controller proceeds to the next stage of the procedure, in which the operator is notified that a sterile connection has been made between tube P and tube D and that a connected tube J has been defined. At this time, the controller unlocks upper jaws 18 and 30 (if they were locked in a closed position). This allows the operator to return upper jaws 18 and 30 to their open position and remove the connected tube J from lower jaws 20 and 32 of carriages 14 and 16, and also remove and discard the "discard ends" W of tubes P and D. The connected tube J is then manipulated (either manually or by a suitably configured device) to open the connection (e.g., by pinching the connection) to allow fluid flow and to ensure that the connection is secure.

[0080] At the end of the procedure, the operator can press a "reset" button to reset the sterile connection device 10, which may include the control commanding the motor to return the second carriage 16 to its initial position.

[0081] It is again emphasized that the illustrated sterile connection devices 10, 10a are merely exemplary, and that sterile connection devices according to the present disclosure may be configured differently without departing from the scope of the present disclosure, including sterile connection devices having different arrangements of components and / or sterile connection devices that include additional components, such as cords for connecting to an external power source, various sensors, and / or a touch screen for use by an operator.

[0082] Aspects Aspect 1. A sterile connection device comprising: a first carriage including a first mandible defining a first portion of a proximal slot configured to receive a portion of a proximal tube and defining a first portion of a distal slot configured to receive a portion of a distal tube; a first upper jaw configured to move from an open state away from the first mandible to a closed state disposed adjacent the first mandible; a second carriage disposed laterally of the first carriage and defining a second portion of the proximal slot and a second portion of the distal slot; and a second carriage including a second upper jaw configured to move between the open state away from the second mandible and the closed state disposed adjacent the second mandible; and a motor configured to move the second carriage from an initial position to a final position, wherein the first and second portions of the proximal slot are aligned at the initial position, the first and second portions of the distal slot are aligned at the initial position, and one of the portions of the proximal slot is aligned with one of the portions of the distal slot at the final position; and the sterile connection device does not include another motor.

[0083] Aspect 2. The sterile connection apparatus of aspect 1, wherein the motor is configured to move the second carriage along an arcuate path from an initial position to a final position.

[0084] Example 3. A sterile connection device of example 2, wherein the motor is configured to move the second carriage through a first portion of an arcuate path from an initial position to an intermediate position, pause the movement of the second carriage at the intermediate position, and move the second carriage through a second portion of the arcuate path from the intermediate position to a final position.

[0085] Embodiment 4. The sterile connection apparatus of embodiment 3, wherein the tubing is heated when the second carriage is in the initial position and the intermediate position.

[0086] Embodiment 5. The sterile connection apparatus of embodiment 4, wherein the tubing is heated by application of radio frequency energy only.

[0087] Aspect 6. A sterile connection device described in any one of aspects 4 to 5, wherein each tube is heated to a first temperature when the second carriage moves away from the initial position, and each tube is heated to a second temperature higher than the first temperature when the second carriage is in an intermediate position.

[0088] Embodiment 7. The sterile connection device of embodiment 6, wherein the first temperature is configured to be below a melting point of the tubing and the second temperature is configured to be at or above a melting point of the tubing.

[0089] Aspect 8. A sterile connection device according to any one of the aspects above, wherein each carriage includes a waste end heating element associated with a portion of a slot defined by the carriage and a mating heating element associated with the portion of the slot defined by the carriage or a portion of another slot defined by the carriage.

[0090] Example 9. The sterile connection device of example 8, wherein each waste end heating element is configured to operate when the second carriage is in an initial position, and each coupled heating element is configured to operate when the second carriage is not in the initial position or the final position.

[0091] Aspect 10. A sterile connection device according to any one of aspects 8-9, wherein each coupling heating element is configured to be movable between a retracted state and a deployed state relative to the carriage with which the coupling heating element is associated.

[0092] Example 11. The sterile connection device of example 10, wherein each coupling heating element is configured to be in a retracted state when the second carriage is in an initial position and a final position, and to be in a deployed state when the coupling heating element is activated.

[0093] Aspect 12. A sterile connection device as described in any one of aspects 10 to 11, wherein each coupled heating element is configured to automatically move from a retracted state toward a deployed state when the second carriage moves away from the initial position.

[0094] Aspect 13. A sterile connection device as described in any one of aspects 10 to 12, wherein each coupled heating element is configured to automatically move from the deployed state to the retracted state when the second carriage is moved to a final position.

[0095] Embodiment 14. A sterile connection device described in any one of embodiments 10-13, wherein each coupled heating element is associated with a side of an associated carriage that faces the other carriage, and each coupled heating element includes an associated bumper configured to move with the coupled heating element between a retracted state and a deployed state, and each bumper is biased to the deployed state, and when the second carriage is in an initial position and a final position, each bumper contacts a carriage with which it is not associated to hold the bumper in the retracted state.

[0096] Embodiment 15. The sterile connection device of any one of embodiments 8-14, wherein each heating element comprises a pair of electrodes.

[0097] Aspect 16. A sterile connection device, comprising: a first carriage including a first mandible defining a first portion of a proximal slot configured to receive a portion of a proximal tube and a first portion of a distal slot configured to receive a portion of a distal tube; a first upper jaw configured to move between an open state spaced apart from the first mandible and a closed state disposed adjacent to the first mandible; a second carriage disposed laterally of the first carriage and including a second mandible defining a second portion of the proximal slot and a second portion of the distal slot; and a second upper jaw configured to move between an open state spaced apart from the second mandible and a closed state disposed adjacent to the second mandible; and a second carriage configured to move at least one carriage from an initial position to a final position. a motor coupled to the carriage, wherein a first and second portion of the proximal slot are aligned at an initial position and a first and second portion of the distal slot are aligned at an initial position and one of the portions of the proximal slot is aligned with one of the portions of the distal slot at a final position, each carriage includes a waste end heating element associated with one portion of the slot defined by the carriage and a coupled heating element associated with the one portion of the slot defined by the carriage or the other portion of the slot defined by the carriage, each waste end heating element configured to operate in the initial position and each coupled heating element configured to operate when the at least one carriage is not in the initial position or the final position.

[0098] Example 17. The sterile connection device of example 16, wherein each mating heating element is configured to be movable between a retracted state and a deployed state relative to a carriage with which the mating heating element is associated.

[0099] Aspect 18. The sterile connection device of aspect 17, wherein each coupling heating element is configured to be in a retracted state when the at least one carriage is in an initial position and a final position, and to be in a deployed state when the coupling heating element is activated.

[0100] Aspect 19. A sterile connection device according to any one of aspects 17-18, wherein each coupled heating element is configured to automatically move from a retracted state towards a deployed state when the at least one carriage moves away from an initial position.

[0101] Aspect 20. A sterile connection device according to any one of aspects 17 to 19, wherein each coupled heating element is configured to automatically move from a deployed state to a retracted state when the at least one carriage is moved to a final position.

[0102] Embodiment 21. A sterile connection device according to any one of embodiments 17-20, wherein each coupled heating element is associated with a side of an associated carriage facing the other carriage, and each coupled heating element includes an associated bumper configured to move with the coupled heating element between a retracted state and a deployed state, each bumper being biased to the deployed state, and each bumper contacting a carriage with which it is not associated and holding the bumper in the retracted state when at least one carriage is in an initial position and a final position.

[0103] Example 22. The sterile connection device of example 16, wherein each coupled heating element is associated with the same portion of the slot as an associated waste end heating element, and none of the coupled heating elements are configured to be movable between a retracted state and a deployed state.

[0104] Embodiment 23 The sterile connection device of embodiment 22, wherein each mating heating element is disposed transversely of an associated waste end heating element.

[0105] Embodiment 24. The sterile connection device of any one of embodiments 22-23, wherein each mating heating element is associated with a side of the associated carriage that faces the other carriage.

[0106] Embodiment 25. A sterile connection device according to any one of embodiments 22 to 24, wherein each waste end heating element and associated mating heating element is disposed between a portion of the associated slot and a side of the associated carriage facing the other carriage.

[0107] Embodiment 26. A sterile connection device described in any one of embodiments 22 to 25, wherein the waste end heating element and the combining heating element of one carriage are associated with a portion of a proximal slot defined by the one carriage, and the waste end heating element and the combining heating element of the other carriage are associated with a portion of a distal slot defined by the other carriage.

[0108] Embodiment 27. The sterile connection apparatus of any one of embodiments 21-26, wherein the motor is configured to move the second carriage from an initial position to a final position.

[0109] Example 28. The sterile connection device of example 27, wherein the motor is configured to move the second carriage from the initial position to the final position through an arcuate path.

[0110] Example 29. The sterile connection device of example 28, wherein the motor is configured to move the second carriage through a first portion of an arcuate path from an initial position to an intermediate position, pause the movement of the second carriage at the intermediate position, and move the second carriage through a second portion of the arcuate path from the intermediate position to a final position.

[0111] Example 30. The sterile connection apparatus of example 29, wherein each coupled heating element is configured to operate when the second carriage is in an intermediate position.

[0112] Example 31. The sterile connection device of any one of Examples 21-30, wherein each heating element is configured to heat a portion of one of said tubes by application of radio frequency energy.

[0113] Aspect 32. A sterile connection device described in any one of aspects 21 to 31, wherein each waste end heating element is configured to heat a portion of an associated tubing to a first temperature when the at least one carriage is moved from an initial position, and each coupled heating element is configured to heat a portion of an associated tubing to a second temperature higher than the first temperature when the coupled heating element is activated.

[0114] Aspect 33. The sterile connection device of aspect 32, wherein the first temperature is set to be lower than the melting point of the portion of the tubing heated by the waste end heating element, and the second temperature is set to be equal to or higher than the melting point of the portion of the tubing heated by the combined heating element.

[0115] Embodiment 34. The sterile connection device of any one of embodiments 21-33, wherein each heating element comprises a pair of electrodes.

[0116] Aspect 35. The sterile connection device according to any one of Aspects 21 to 34, wherein the sterile connection device does not include another motor.

[0117] Aspect 36. A sterile connection device, comprising: a first carriage including a first mandible defining a first portion of a proximal slot configured to receive a portion of a proximal tube and a first portion of a distal slot configured to receive a portion of a distal tube; a first upper jaw configured to move between an open state spaced apart from the first mandible and a closed state disposed adjacent to the first mandible; a second carriage disposed laterally of the first carriage and including a second mandible defining a second portion of the proximal slot and a second portion of the distal slot; and a second upper jaw configured to move between an open state spaced apart from the second mandible and a closed state disposed adjacent to the second mandible; and a second carriage configured to move at least one carriage from an initial position to a closed state. and a motor configured to move the at least one carriage to an initial position, an intermediate position, a final position, wherein in the initial position, the first and second portions of the proximal slots are aligned and the first and second portions of the distal slots are aligned, a portion of each tube is heated, and upon moving the at least one carriage from the initial position to the intermediate position, the heated portion of each tube is torn to define a torn end, the heated portion of each tube is torn at a first temperature less than a melting point of the heated portion, at the intermediate position, the torn end of each tube is heated to a second temperature equal to or greater than a melting point of the torn end, and at the final position, one of the portions of the proximal slot is aligned with one of the portions of the distal slot, and the torn ends of the tubes are aligned and joined.

[0118] Example 37. The sterile connection device of example 36, wherein the sterile connection device does not include another motor.

[0119] Embodiment 38. The sterile connection device of any one of embodiments 36-37, wherein the tubing is heated by application of radio frequency energy only.

[0120] Embodiment 39. A sterile connection device described in any one of embodiments 36 to 38, wherein each carriage includes a waste end heating element associated with a portion of a slot defined by the carriage and a mating heating element associated with the portion of the slot defined by the carriage or a portion of another slot defined by the carriage.

[0121] Aspect 40. The sterile connection device of aspect 39, wherein each waste end heating element is configured to operate when the at least one carriage is in an initial position.

[0122] Embodiment 41. A sterile connection device according to any one of embodiments 39-40, wherein each coupled heating element is configured not to operate when the at least one carriage is in the initial position and the final position.

[0123] Example 42. The sterile connection device of any one of Examples 39-41, wherein each coupled heating element is configured to operate when the at least one carriage is in an intermediate position.

[0124] Aspect 43. A sterile connection device described in any one of aspects 39 to 42, wherein each coupling heating element is configured to be movable between a retracted state and a deployed state relative to the carriage with which the coupling heating element is associated.

[0125] Embodiment 44. The sterile connection device of embodiment 43, wherein each coupled heating element is configured to be in a retracted state when the at least one carriage is in an initial position and a final position, and configured to be in a deployed state when the at least one carriage is in an intermediate position.

[0126] Aspect 45. A sterile connection device described in any one of aspects 43 to 44, wherein each coupled heating element is configured to automatically move from a retracted state toward a deployed state when the at least one carriage moves away from an initial position.

[0127] Aspect 46. A sterile connection device described in any one of aspects 43 to 45, wherein each coupled heating element is configured to automatically move from a deployed state to a retracted state when the at least one carriage is moved to a final position.

[0128] Embodiment 47. A sterile connection device according to any one of embodiments 43-46, wherein each coupled heating element is associated with a side of an associated carriage facing the other carriage, and each coupled heating element includes an associated bumper configured to move with the coupled heating element between a retracted state and a deployed state, each bumper being biased to the deployed state, and when the at least one carriage is in an initial position and a final position, each bumper contacts a carriage with which it is not associated to hold the bumper in the retracted state.

[0129] Embodiment 48. The sterile connection device of any one of embodiments 39-47, wherein each heating element comprises a pair of electrodes.

[0130] Embodiment 49. The sterile connection apparatus of any one of embodiments 36-48, wherein the motor is configured to move the second carriage from the initial position to the intermediate position and to the final position.

[0131] Embodiment 50. The sterile connection device of embodiment 49, wherein the motor is configured to move the second carriage through a first portion of the arcuate path from an initial position to an intermediate position, pause the movement of the second carriage at the intermediate position, and move the second carriage through a second portion of the arcuate path from the intermediate position to a final position.

[0132] Aspect 51. A method of aseptically connecting two tubes, comprising heating a portion of each of two tubes, cutting each tube at the heated portion to define a cut end of each tube, moving the cut ends of the two tubes into contact with each other, and joining the cut ends of the tubes, wherein the tubes are heated and joined without application of any type of energy other than radio frequency energy.

[0133] Example 52. The method of Example 52, wherein the tube is heated and cut without scissors (cutting) the tube.

[0134] Embodiment 53. The method according to any one of embodiments 51-52, wherein the heated portion of the tube does not melt when the heated portion of the tube is cut.

[0135] Embodiment 54. The method of any one of embodiments 51-53, further comprising heating the cut ends of the tube prior to moving the cut ends of the tube into contact with one another.

[0136] Example 55 The method of example 54, wherein the cut end of the tube is heated by application of radio frequency energy, and no other type of energy is applied.

[0137] Embodiment 56 The method of any one of embodiments 54-55, wherein the cut ends of the tube are melted as the cut ends of the tube are brought into contact with one another.

[0138] Embodiment 57. The method of any one of embodiments 51-54, wherein the tubes are heated, cut, moved, and joined by the action of a single motor.

[0139] Embodiment 58. The method of embodiment 57, further comprising mounting two tubes in a first carriage and a second carriage prior to heating the tubes, and a single motor is actuated to move the second carriage from an initial position where the tubes are heated to a final position where the cut ends of the tubes are joined without moving the first carriage.

[0140] Example 59. The method of example 58, wherein the second carriage is moved through an arcuate path when moving from the initial position to the final position.

[0141] Example 60. The method of example 59, wherein the second carriage is moved through a first portion of the arcuate path from an initial position to an intermediate position, the movement of the second carriage is paused at the intermediate position, and the second carriage is moved through a second portion of the arcuate path from the intermediate position to a final position.

[0142] Example 61 The method of Example 60, wherein the heated portion of the tube is disconnected when the second carriage is moved from the initial position to the intermediate position.

[0143] Embodiment 62. The method of any one of embodiments 60-61, wherein the cut end of the tube is heated while the second carriage is in the intermediate position.

[0144] Example 63. The method of example 62, wherein each carriage includes a coupled heating element configured to heat a cut end of a different one of the two tubes, each coupled heating element being in a retracted state when the second carriage is in an initial position and a final position, and each coupled heating element being in a deployed state when the second carriage is in an intermediate position.

[0145] Example 64. The method of example 63, wherein each coupled heating element is configured to automatically move from a retracted state toward a deployed state when the second carriage moves away from the initial position, and wherein each coupled heating element is configured to automatically move from the deployed state to the retracted state when the second carriage is moved to the final position.

[0146] Embodiment 65. The method of any one of embodiments 63 to 64, wherein each coupled heating element is associated with a side of an associated carriage that faces the other carriage, and each coupled heating element includes an associated bumper configured to move with the coupled heating element between a retracted state and a deployed state, and each bumper is biased to the deployed state, and each bumper contacts a carriage with which it is not associated to hold the bumper in the retracted state when the second carriage is in an initial position and a final position.

[0147] It will be understood that the above-described embodiments are illustrative of some applications of the principles of the present invention. Numerous modifications may be made by those skilled in the art without departing from the spirit and scope of the claimed subject matter, including combinations of features that are individually disclosed or claimed herein. For these reasons, it will be understood that the scope of the present invention is not limited to the above description, but is as set forth in the following claims, which may be directed to features of the present invention, including combinations of features that are individually disclosed or claimed herein.

Claims

1. A method for aseptically connecting two tubes, comprising: heating a portion of each of the two tubes; cutting each tube at the heated portion to define a cut end of each tube; moving the cut ends of two of the tubes into contact with each other; joining the cut ends of the two tubes; A method wherein the tubes are heated and bonded without the application of any type of energy other than radio frequency energy.

2. The method of claim 1, wherein the tube is cut by heating without being cut.

3. The method of claim 1, wherein the heated portion of the tube does not melt when cut.

4. The method of claim 1, further comprising heating the cut ends of the tube before moving the cut ends of the tube into contact with each other.

5. The method of claim 4, wherein the cut end of the tube is heated by application of high frequency energy and no other type of energy is applied.

6. The method of claim 4, wherein the cut ends of the tube are melted when the cut ends of the tube are moved into contact with each other.

7. The method of claim 1, wherein the tubes are heated, cut, moved, and joined by the operation of a single motor.

8. The method of claim 7, further comprising mounting two tubes in a first carriage and a second carriage before heating the tubes, and operating the single motor to move the second carriage from an initial position where the tubes are heated to a final position where the cut ends of the tubes are joined without moving the first carriage.

9. The method described in claim 8, wherein the second carriage is moved through an arc-shaped path when moving from the initial position to the final position.

10. The second carriage is moved from the initial position to an intermediate position through a first portion of the arcuate path; the movement of the second carriage is paused at the intermediate position; The method of claim 9 , wherein the second carriage is moved through a second portion of the arcuate path from the intermediate position to the final position.

11. The method described in claim 10, wherein the heated portion of the tube is cut off when the second carriage is moved from the initial position to the intermediate position.

12. The method of claim 10, wherein the cut end of the tube is heated when the second carriage is in the intermediate position.

13. The first carriage and the second carriage include coupled heating elements configured to heat the cut ends of different ones of the two tubes; each of the coupled heating elements is in a retracted state when the second carriage is in the initial position and the final position; The method of claim 12 , wherein each of the coupled heating elements is in a deployed state when the second carriage is in the intermediate position.

14. The method of claim 13, wherein each of the coupled heating elements is configured to automatically move from the retracted state toward the deployed state when the second carriage moves away from the initial position; The method of claim 13 , wherein each of the coupled heating elements is configured to automatically move from the deployed state to the retracted state when the second carriage is moved to the final position.

15. Each of the coupled heating elements is associated with a side of the associated carriage facing the other of the carriages; each said coupled heating element includes an associated bumper configured to move with said coupled heating element between said retracted state and said deployed state; each said bumper being biased to said deployed state; 15. The method of claim 13 or claim 14, wherein each of the bumpers contacts the carriage with which it is not associated to hold the bumper in a retracted state when the second carriage is in the initial position and the final position.

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