Tube sealing and cutting device

Abstract

To provide an improved tube sealing and cutting device.SOLUTION: A tube sealing device 100 includes a sealing iron 1 having a tube sealing end and an isolation shroud 2 having a tube clamping end 14, with the sealing iron being at least partially disposed within the isolation shroud 2. The device further includes an anvil 5 having a cutting detail and an adhesive prevention film 3 disposed between the anvil and the tube clamping end of the isolation shroud. The sealing iron and isolation shroud are configured to advance toward a tube to be sealed, positioned between the adhesive prevention film and the anvil. The tube clamping end is configured to clamp the tube via the adhesive prevention film. The sealing iron is configured to advance toward the tube to melt and seal the tube against the cutting detail via the adhesive prevention film.SELECTED DRAWING: Figure 1A

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of the earlier filing date of U.S. Provisional Application No. 62 / 820,372, filed March 19, 2019, the disclosure of which is incorporated herein by reference. [Background technology]

[0002] Embodiments of the present disclosure relate to equipment used in bioprocessing, cell therapy, and regenerative medicine manufacturing. The equipment is designed to automate and control a variety of processes that typically require the use of valves, pumps, and other devices to manipulate and process various media within a functionally closed disposable set. The equipment most commonly operates within clean rooms within drug manufacturing plants.

[0003] For many processes, there is a need to separate the tubes to aseptically seal and isolate media, product, QC samples, or simply to break down larger, more complex sets into smaller subsets for easy management and preparation for disposable use. Summary of the Invention

[0004] The present invention will now be described with reference to the accompanying drawings, which show non-limiting examples of embodiments of the invention. [Brief explanation of the drawings]

[0005] [Figure 1A] 1 is a cross-sectional view of a tube sealing and cutting device in a starting position, according to a non-limiting example embodiment. [Figure 1B] 1B is the tube sealing and cutting apparatus of FIG. 1A, with the sealing cycle beginning. [Figure 1C] 1B is the tube sealing and cutting apparatus of FIG. 1A with sealing beginning. [Figure 1D]1B is a tube sealing and cutting apparatus of FIG. 1A, where the solidification and cutting of the seal (or thinning of the tube to the point of separation) has begun. [Figure 1E] 1B is a view of the tube sealing and cutting device of FIG. 1A, with sealing and cutting or separation completed; [Figure 2] 1 is a schematic diagram of a tube sealing and cutting device for a bag filling application. [Figure 3A] 10 is a cross-sectional view of another exemplary embodiment of a tube sealing and cutting device in a standby / tube loading position with the door in an open position. [Figure 3B] 3B is a cross-sectional view of the tube sealing and cutting device of FIG. 3A in a sealing and cutting position. [Figure 3C] FIG. 3B is a detailed view of FIG. 3B. DETAILED DESCRIPTION OF THE INVENTION

[0006] There are significant advantages and risk reductions that can be realized by automating the sealing and cutting of tubing. The equipment available to perform the sealing and sterile isolation operations has a range of disadvantages: · Expensive (i.e., expense and / or wear and tear per cut (e.g., sterile separators, clamp sleeves, Clipster™ sterile tube separator system)). · Takes a long time to actuate or apply. · They are dangerous (e.g. clamp sleeve cutters, cutting clamp sleeves often creates sharp corners that may require the application of additional protective cover components). · Requires significant tubing length and / or space around the tubing to operate the device and create a seal to achieve isolation. · Unless it is a portable device, it requires service for non-manual / non-battery operated devices (AC power, compressed air). · Restrictions on tube material (i.e., only RF (radio frequency) sealers work on tubes containing polar materials, e.g., PVC, EVA). · Constraints on pipe dimensions (i.e. outer shape and wall thickness). Ability to safely and reliably seal fluid-filled tubes (e.g., RF tube sealers can arc when sealing fluid-filled tubes, potentially causing the fluid inside the tube to ground and leading to pinholes in the tube wall).

[0007] Potential advantages of embodiments of the present disclosure, particularly when incorporated into instrument elements, can address several shortcomings of many of the currently available tube sealing and cutting options. Advantages include: A reliable sealing and cutting process that results in consistent sealing and separation of tubes without the need for scissors or other sharp objects, which are often used to separate sealed tubes but pose special risks to the operator regarding potential bio-contamination. · Ability to perform sealing and cutting operations on a variety of tube materials and sizes with slight changes in operating parameters and configurations. Relatively quick sealing and cutting cycle times. · Incorporate into the platform the necessary precautions to protect the operator. Tight integration of tube sealing and cutting equipment to allow for the shortest possible tube length, which allows for the most compact and cost-effective disposable set and, in some cases, can result in reduced media loss (i.e., waste) and maximum performance (i.e., precise fluid delivery control / supply). · Automation to minimize operator interaction. No significant costs per sealing and cutting (as is the case with consumable technologies).

[0008] Thus, embodiments of the present disclosure incorporate improved tube sealing and cutting devices into this conventional equipment. These embodiments achieve fast sealing and cutting cycle times, while maintaining robust and repeatable sealing and cutting. These embodiments also systematically avoid exposing operators to dangerous heat and destroying tubes, which are risks of some current separation methods and can lead to process leaks and possible production or even batch loss.

[0009] Electrically heated sealing irons are often used to seal tubes made of thermoplastic materials. The sealing irons typically have a non-stick coating to prevent the tube material from adhering to the iron and leaving behind residue. When such devices are used for tube sealing, they are also manually operated. This requires human manipulation with dexterity and vision to load and unload the tube, and to peel the tube from the iron if it becomes slightly stuck to ensure there is no residue or to remove it so as not to adversely affect subsequent welding. Additionally, for the sake of seal integrity and operator safety, current technology limits the unit to relatively long cycle times (i.e., several minutes) because it can only heat, seal, and cool when latched closed.

[0010] Also, embodiments incorporate a cutting detail on the anvil that opposes the sealing iron. This feature is used with impulse and RF (radio frequency) sealers used on tubes. The concept is that the tube material melts and flows, thinning the area where it is cut, ensuring a complete seal on the adjacent surfaces. Thus, the cut or separation is accomplished aseptically, with the interior surface (and contents) of the tube not exposed to the exterior.

[0011] In the disclosed embodiment, the anvil or seal backup is attached to a door that is hinged out of the way to allow loading of the disposable set, but is then latched closed to precisely establish tube position and anvil placement. Additionally, the door is interlocked to ensure that the operator does not have access to dangerous heating or pinch points, yet the tube sealing and cutting operations can occur.

[0012] The disclosed embodiment comprises: The tube sealing and cutting operation is performed by clamping a heated sealing iron against the tube via an anti-stick film which helps to avoid sticking of the tube after the cutting and sealing operation. Retracting the sealing iron (after optimal sealing and cutting parameters (i.e., force and temperature) have been achieved) allows for short cycle times, allows operator access without excessive delays due to required manual interaction, and without access / exposure to dangerous heating and pinch points. · Maintains sealing irons at the proper temperature without operator access / exposure to dangerous heat and pinch points.

[0013] The membrane is thin and flexible, allowing it to conform and bend to the shape of the sealing iron (and surrounding isolation shroud). The fact that the membrane is non-stick enhances sealing and cutting, along with the appropriate release properties to prevent tubes from sticking, and aids in unloading (automatic or manual) following the sealing and cutting cycle. With regard to equipment design and cleanroom installation / operation compatibility, the membrane also serves to separate the heater and associated actuation and other mechanisms that may otherwise pose clean / cleanable design challenges. This membrane becomes a surface that the operator faces and must clean and maintain.

[0014] Embodiments of the present disclosure include an iron preheated to a predetermined temperature that rapidly transfers through the thin film material, causing the requisite melting, and then retracting the iron after the cut or tube separation is fully established. These aspects contribute to relatively quick cycle times that can be routinely achieved, necessary for maximizing productivity benefits and subsequent consistent, leak-free sealing and cutting performance requirements.

[0015] 1A-1E, a tube sealing apparatus 100 according to an exemplary embodiment of the present disclosure is sequentially illustrated. The tube sealing apparatus 100 includes a heating block or tube sealing iron 1 translationally disposed within an isolation shroud 2. The sealing iron 1 has a sealing end 12 with a stepped portion at its sealing surface end. The isolation shroud 2 has a tube clamping end 14 with a narrow portion corresponding to the stepped portion of the sealing end 12. A seal backup or anvil 5 is disposed at the tube clamping end 14 of the isolation shroud 2 and is attached to a rigid reaction surface or safety interlock door (not shown in FIGS. 1A-1E) that limits finger access by an operator. The anvil 5 includes a small tube cutting detail 16 thereon facing the tube clamping end 14 of the isolation shroud 2. The cutting detail 16 may be configured as a ridge that provides thinning of the tube material after a seal is established in this section of the tube. This allows for quick separation of the tube ends by an operator with minimal to no pulling or peeling force required to cut the newly established sealed tube end without the need for tools or sharp objects and without the risk of destroying the tube seal. The anti-adhesive film 3 is disposed between the tube clamping end 14 of the isolation shroud 2 and the anvil 5. The tube 4 to be sealed is located between the anti-adhesive film 3 and the anvil 5. The isolation shroud 2 is configured to operate in a reciprocating manner, advancing toward and retracting away from the anvil 5. The sealing iron 1 is configured to operate in a reciprocating manner, advancing toward and retracting away from the anvil 5, and is also configured to move relative to the isolation shroud 2. The sealing iron 1 and isolation shroud 2 can be reciprocated using a mechanism as described below with reference to Figures 3A-3C.

[0016] 1A-1E illustrate the tube sealing and cutting procedure. Referring to FIG. 1A, the starting position is shown with the isolation shroud 2 and sealing iron 1 fully retracted from the anvil 5.

[0017] Referring to FIG. 1B, the start of the sealing cycle is shown as the isolation shroud 2 and sealing iron 1 advance to press the tube 4 through the membrane 3 against the anvil 5 .

[0018] 1C, a further progression of the sealing cycle is shown, where the isolation shroud 2 and sealing iron 1 advance further to press the tube 4 through the membrane 3 against the cutting detail 16 on the anvil 5, where material of the tube 4 melts and seals with the sealing iron 1 to maintain pressure. Material flows out of the cutting detail 16 as the sealing iron 1 contacts the cutting detail 16 through the membrane 3 and cuts open the tube 4.

[0019] 1D, the seal and cut integration position is shown, where the tube material is solidified with the retracted sealing iron 1. In this configuration, the isolation shroud 2 advances and remains clamped on the tube 4 as the tube material solidifies, ensuring that the seal remains established, especially due to the high stiffness of the tube material and the resilience forces that would cause the seal to break or otherwise be compromised during the short solidification period.

[0020] Referring to FIG. 1E, the sealing and cutting completed position is shown, where both the isolation shroud 2 and the sealing iron 1 have retracted away from the anvil 5, and where the tube 4 has been sealed and cut or separated into two separate elements, allowing the tube and the connecting elements on the left and right sides of the newly established cutting or separation point to be separated from each other.

[0021] The isolation shroud 2 helps reduce energy usage due to radiation and convection losses. This configuration plays a key role in clamping the tube 4 and providing a temperature gradient that limits the melt boundary within the tube 4, especially for thin-walled and rigid tubes. Restoring forces can lead to stresses at the melt transition that could otherwise cause the tube wall to fracture. The isolation shroud 2 clamps the tube 4, preventing the transition from a flat, clamped tube to its natural round state at the high temperature / melt zone. This helps provide the necessary margin for a stronger seal, especially on thin-walled (e.g., 0.5 mm or less) tubes. Additionally, if the sealed tube 4 is liquid-filled, the isolation shroud 2 serves to impede and help force the fluid out of the sealing and high temperature zone, preventing the fluid from being exposed to high temperatures. This reduces excessive pressure buildup by the fluid / evolved gases that could cause potential boiling and rupture of the molten tube wall during the sealing process. Depending on the application, these may be residual or induced tensions on the tube 4. Because the isolation shroud 2 is configured as a clamp, it can also act to isolate tension and prevent the seal from being compromised by the tube 4 being under tension, which would otherwise quite easily lead to stretching or elongation of the fused section of the tube, resulting in destruction of the seal or the tube wall.

[0022] Regarding the integration of this tube sealing device 100, in various configurations, it can be utilized to aid in sealing and cutting different tube materials and wall thicknesses. In bag filling applications where there are multiple bags in a row, the door can cover all bags and filled tubes, with successive or individual anvils backing up each tube except for the traversing sealer. In this regard, a single sealer can help provide uniformity in terms of force and temperature for each tube, which has been commonly utilized when multiple service locations significantly reduce the cost and complexity of the equipment control system by avoiding having multiple sealing heads. Also, in bag filling embodiments, bags are often filled sequentially, with a single traversing device, and tube cutting and sealing can occur directly following the filling of one bag while the next bag is being filled. In this way, productivity is maximized by avoiding the need to seal and cut all bags at the end of filling. Instead, the present invention allows bags to be made available and removed in a timely manner, allowing subsequent processing to occur sequentially and directly after the tube sealing and cutting process is complete. Referring to FIG. 2, a bag filling application 18 is shown illustrating the progressive filling of a bag 20 with a tube 4, sealing and cutting with a tube sealing device 100, and subsequent removal of the bag 20.

[0023] 3A-3C, another exemplary embodiment is shown. This embodiment incorporates most of the features described in the previous embodiment. In this embodiment, the iron 1 and shroud 2 move together rather than relative to each other, and their sealing end and tube clamping end, respectively, do not have corresponding narrow features.

[0024] Referring to Figure 3A, the tube sealing and cutting apparatus is shown in a standby position ready for installation / loading of tube 4. The membrane 3 is fixed to a membrane holder on the housing 6 and is a 3" (75 mm) wide web or strip of membrane film clamped to the holder which helps to form / achieve the required convex 2D shape. If necessary, the membrane holder is removable from the platform for membrane replacement and maintenance.

[0025] A typical example where this sealing and cutting device can be used is a bag that needs to be filled with a required amount of fluid and then aseptically sealed and separated. In this example, a disposable set including the bag and filling tube can be loaded onto the system, the tube section extending in front of the membrane 3 at the required location would be sealed and cut, and then the door 7 would be closed on the tube 4 to bring the anvil 5 into position.

[0026] Referring to Figures 3B and 3C, the tube sealing and cutting system is shown in the sealing position. Continuing with the bag-filling example, after the bag is filled, the heated sealing iron 1 assembly is actuated forward, forcing the tube 4 through the non-stick membrane 3 against the anvil 5, resulting in the sealing and cutting / separation of the tube 4 as outlined above with respect to Figures 1A-1E. The mechanism used to move / actuate the components actively involved in the sealing function can be a pneumatic cylinder and electric actuator, or, as shown, a guided ball-screw actuator including an electric motor assembly 9 that moves the sealing iron 1 assembly carrier 10. Force control, with respect to the sealing iron assembly's ability to move forward and maintain force during the sealing operation as the tube melts and flows, is important and a useful aspect for achieving repeatability in this system. This can also be achieved using a guided pneumatic cylinder (for pneumatically actuated systems). With an electric actuator, force control can be achieved using torque (i.e., motor current) control, or in another embodiment, a spring-loaded head with variable position adjustment (i.e., stroke) that controls the force applied during the sealing operation.

[0027] At the end of the sealing cycle, the heated sealing iron 1 assembly retracts rearward, clear of the membrane 3 and anvil 5, allowing the molten tube 4 material to solidify, completing the sealing and cutting. This sealing process can be repeated multiple times across to allow for the sealing and cutting of multiple adjacent tubes 4. At the end of the process, the door 7 is opened and the filled, sealed and separated bags are removed for subsequent processing (labeling, packaging, freezing, etc.).

[0028] Exemplary operating parameters are listed below. Iron temperature: Operating range = 100°C → 200°C, typical seal range dependent on tube. Nominal set point = 160°C. Potential high temperature for intermittent operation is 350°C. Iron contact time: Operating range = 6 to 30 seconds, depending on the tube. Iron pressure / force: Operating range = 80N → 200N. Nominal setting value = 120N.

[0029] The iron 1 may be made of aluminum or other suitable thermally conductive material. The shroud 2 and anvil 5 may be made of polyether ether ketone (PEEK) or other suitable material with high continuous operating temperature capability. The anti-adhesion film 3 may be made of PEEK or polyimide film or other suitable material that is suitably thin and flexible so that heat can be easily transferred therethrough from the sealing iron assembly to the tube, yet capable of intermittently withstanding processing temperatures without degradation.

[0030] Features of the disclosed embodiments can be combined, rearranged, omitted, etc., within the scope of the present invention to create additional embodiments. Furthermore, in some cases, certain features can be used to their advantage without the concomitant use of other features.

[0031] Many alternatives, modifications, and variations are possible with this disclosure. While particular embodiments have been shown and described to illustrate the application of the principles of the invention, it is to be understood that the invention can be embodied without departing from such principles. Accordingly, the applicant intends to embrace all alternatives, modifications, equivalents, and variations that are within the spirit and scope of the invention. [Explanation of symbols]

[0032] 1 sealing iron 2 Isolation Shroud 3 Anti-adhesion film 4. Body 5 Anvil 12 Sealed end 14 Tube Clamp End 16 Cutting Details 100 Tube sealing device

Claims

1. 1. A method for preparing a tube, comprising: positioning the tube between a sealing iron surrounded by an isolation shroud and an anvil; compressing the tube by advancing the isolation shroud toward the anvil; cutting the tube with a cutting detail on the anvil; sealing the tube with the sealing iron; A method for providing

2. The method of claim 1 , further comprising disposing an anti-adhesion film between the isolation shroud and the tube.

3. The method of claim 2 , wherein the cutting and sealing steps are performed through the anti-adhesion film.

4. The method of claim 1 , further comprising the step of retracting the sealing iron away from the tube after sealing the tube with the sealing iron.

5. The method of claim 4 , wherein the step of retracting the sealing iron further comprises maintaining compression of the tube between the isolation shroud and the anvil.

6. The method of claim 5 , wherein the step of retracting the sealing iron further comprises allowing the tube material to solidify for a period of time.

7. 7. The method of claim 6, further comprising the step of retracting the isolation shroud from the tube after the step of retracting the sealing iron, wherein the tube forms two separate pieces.

8. The method of claim 7 , further comprising the step of removing at least one piece of the tube after the step of retracting the isolation shroud.

9. The method of claim 1 , wherein the tube is part of a bag.

10. 10. The method of claim 9, further comprising the step of filling the bag with material through the tube prior to the step of positioning the tube.

11. 11. The method of claim 10, further comprising the step of removing the bag from a tube cut and seal device after the tube sealing step.

12. 12. The method of claim 11, wherein each step is repeated sequentially to create multiple bags.

13. The method of claim 1 , wherein the cutting details are configured as ridges that cause thinning of the tube after the step of sealing the tube with the sealing iron.

14. The method of claim 1 , wherein the cutting detail is configured to allow material of the tube to flow away from the cutting detail.

15. 10. The method of claim 1, wherein the step of sealing the tube occurs when the sealing iron is at a temperature between 100°C and 350°C.

16. 2. The method of claim 1, wherein the step of sealing the tube occurs when the sealing iron contacts the tube for between 6 and 30 seconds.

17. 2. The method of claim 1, wherein the step of sealing the tube occurs when the sealing iron contacts the tube with a force between 80N and 200N.

18. The method of claim 1 , wherein the isolation shroud and the anvil are constructed from polyetheretherketone (PEEK).

19. The method of claim 3 , wherein the anti-adhesion film is composed of a polyetheretherketone or polyimide film.

20. The method of claim 1 , wherein the step of sealing the tube further comprises melting the tube with the sealing iron.

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