Apparatus and method for removing twists from plastic tubes

Abstract

To provide a kit for removing a kink in a plastic tubing for its use in a blood transfusion medicine.SOLUTION: A kit comprises a blood bag connected to a tubing and a rigid sleeve screwed onto the tubing. The rigid sleeve has an outer diameter 41, an inner diameter 42, a thickness 43, a length 44, and an inner cylindrical surface. The inner diameter 42 is larger than the outer diameter 31 of the tubing. The sleeve is used to remove a kink in the tubing and restore fluid flow. The flexural elastic modulus of the rigid sleeve exceeds 2 gigapascals (GPa). The rigid sleeve has an outer shape selected from the group consisting of a square, triangle, rectangle, cylinder, hexagon, equilateral shape, quadrilateral, pentagon, and trapezoid.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims priority from U.S. Provisional Patent Application No. 62 / 787,606, filed on January 2, 2019, which is hereby incorporated by reference in its entirety.

[0002] The present invention relates to an apparatus for removing kinks from plastic tubing for its use in transfusion medicine.

Background Art

[0003] Plastic tubing is used to transfer fluids and is a component of fluid delivery and collection kits. Such tubing is typically made of polyvinyl chloride (PVC) and is subject to folding or kinking, which results in an undesirable or unusable reduction in the lumen of the tubing for fluid flow. The use of plastic tubing clamps in delivery and collection kits (e.g., blood collection kits) can also kink the plastic tubing during storage, thereby reducing or completely occluding the lumen of the tubing and preventing fluid flow. This problem is exacerbated by sterilization, especially when the clamp remains in the closed position, either intentionally or accidentally.

[0004] In addition, it is common practice to utilize sterilization connection devices ("SCDs") to join pieces of different tubing. When pieces of tubing are joined by an SCD, they typically have sections adhered together, similar to kinking, which must be manipulated to restore fluid flow internally. Another source of kinking is folding within the tubing. The present invention overcomes kinking and folding to restore fluid flow in kinked sections of tubing.

Summary of the Invention

[0005] The present disclosure provides and includes a device for restoring flow to a twisted tube, comprising a sleeve having a cylindrical inner surface larger than the outer diameter of the tube, wherein the sleeve is slidable along the tube so as to compress the twisted tube perpendicular to the twist.

[0006] The disclosure also provides, and includes, a method for removing twisting within a tube, which includes sliding a sleeve having a cylindrical inner diameter along the tube.

[0007] The disclosure further provides, and includes, a device for restoring flow to a twisted tube, comprising a sleeve having a cylindrical inner surface less than or equal to the outer diameter of the tube and capable of compressing the twisted tube perpendicular to the twist. [Brief explanation of the drawing]

[0008] This disclosure is provided with reference to the attached drawings. [Figure 1] The sleeve is shown with an outer diameter (41), inner diameter (42), thickness (43), and length (44) to eliminate twisting. [Figure 2] The sleeve on the clamp tube according to Example 1 is shown. [Figure 3A-3B] This shows a twisted PVC tube according to Example 1. [Figure 4A-4B] This shows a PVC tube with twisting removed using a sleeve, according to Example 1. [Figure 5A-5B] This shows an open sleeve having a living hinge that is smaller (A) or larger (B) than the longitudinal length of the sleeve. [Figure 6] An exemplary embodiment of the sleeve described herein is shown. [Figure 7A-7C] (B) An exemplary embodiment of a sleeve (A) including an hourglass shape or (C) a cutout is shown. [Figures 8A-8D]An exemplary embodiment of a sleeve (A) including an opening (B) located on a twisted tube (C and D) is shown.

[0009] The examples described herein illustrate some embodiments of the disclosure, but should not be construed as limiting the scope of the disclosure in any way. [Modes for carrying out the invention]

[0010] This disclosure relates to and includes a sleeve having a cylindrical inner surface for restoring flow to a twisted tube. In some aspects of this disclosure, the sleeve is made of a material selected from the group consisting of polyethylene (PE), polypropylene (PP), metal, polyethylene terephthalate (PETG), polyvinyl chloride (PVC), PC, acrylic, nylon, acrylonitrile-butadiene-styrene (ABS), polytetrafluoroethylene (PTFE or Teflon®), polyvinylidene fluoride (PVDF), polyetheretherketone (PEEK), chlorinated polyvinyl chloride (CPVC), fluorinated ethylene propylene (FEP), perfluoroalkoxyalkane (PFA), polyimide, acetal, polyetherimide, and Ultem. In another embodiment, the sleeve comprises two or more materials selected from the group consisting of polyethylene (PE), polypropylene (PP), metal, polyethylene terephthalate (PETG), polyvinyl chloride (PVC), PC, acrylic, nylon, acrylonitrile-butadiene-styrene (ABS), polytetrafluoroethylene (PTFE or Teflon), polyvinylidene fluoride (PVDF), polyetheretherketone (PEEK), chlorinated polyvinyl chloride (CPVC), fluorinated ethylene propylene (FEP), perfluoroalkoxyalkane (PFA), polyimide, acetal, polyetherimide, and Ultem. In yet another embodiment, the sleeve comprises PVC.

[0011] In aspects of this disclosure, the sleeve includes an inner cylindrical surface and an outer surface. In one aspect, the outer surface of the sleeve includes a raised feature. In another aspect, the outer surface of the sleeve includes a feature selected from the group consisting of stippling, ribbing, and knurling. In yet another aspect, the outer surface of the sleeve includes diamond knurling. In yet another aspect, the outer surface of the sleeve includes straight knurling. In yet another aspect, the outer surface of the sleeve includes straight oblique knurling. In yet another aspect, the inner surface includes a chamfer.

[0012] In one embodiment, the sleeve has an external shape selected from the group consisting of square, triangle, rectangle, cylinder, hexagon, equilateral, quadrilateral, pentagon, hourglass, and trapezoid.

[0013] In one embodiment of this disclosure, the sleeve is semi-rigid. In another embodiment, the sleeve is rigid. In yet another embodiment, the sleeve is flexible. The rigidity of the polymer is described by the flexural modulus (or modulus in bending), which is the ratio of stress to strain of the polymer. In one embodiment, the flexural strength of the sleeve is about 0.04, 0.07, 0.075, 0.08, 0.09, 0.1, 0.12, 0.14, 0.15, 0.16, 0.18, 0.2, 0.25, or 0.27 gigapascals (GPa). See "MatWeb, Flexural Strength Testing of Plastics" (available online at www(dot)matweb(dot)com / reference / flexuralstrength.aspx) and "Omnexus, Fluxural Modulus or Bend Modulus" (available online at omnexus(dot)specialchem(dot)com / polymer-properties / properties / stiffness). In another embodiment, the flexural modulus of the sleeve is 1.0–3.0, 4.0–6.0, 2.0–4.0, 5.0–7.0, 3.0–5.0, 1.0–5.0, 5.0–9.0, 7.0–9.0, 0.0005–3.0, 4.0–7.0, 0.5–2.0, and 0.0005–1.0 gigapascals (GPa). Stiffness increases as GPa increases.

[0014] In one embodiment of this disclosure, the sleeve includes an outer diameter 41, an inner diameter 42, a thickness 43, and a length 44, as shown in Figure 1. In one embodiment, the inner diameter of the sleeve is equal to the size of the outer diameter of the tube 31 including the twist. In another embodiment, the inner diameter of the sleeve is smaller than the outer diameter of the tube including the twist. In one embodiment, the sleeve slides on the tube including the twist. In another embodiment, the inner diameter 42 of the sleeve is approximately 4.32 mm. In another embodiment, the inner diameter 42 is 3 to 5 mm. In another embodiment, the inner diameter 42 is 3.5 to 5 mm. In yet another embodiment, the inner diameter 42 is 4 to 5 mm. In yet another embodiment, the inner diameter 42 is 4.2 to 5 mm.

[0015] In one embodiment, the outer diameter 41 of the sleeve is approximately 6.35 mm. In another embodiment, the outer diameter 41 is at least 5 mm. In another embodiment, the outer diameter is 5 to 12 mm. In another embodiment, the outer diameter is 10 to 12 mm. In another embodiment, the outer diameter 41 is 10 to 18 mm. In another embodiment, the outer diameter 41 is 5 to 18 mm. In another embodiment, the outer diameter 41 is less than 18 mm. In another embodiment, the outer diameter 41 is at least 0.5 mm larger than the inner diameter. In another embodiment, the outer diameter 41 is at least 1.5 mm larger than the inner diameter. In yet another embodiment, the outer diameter 41 is at least 50% larger than the inner diameter. In yet another embodiment, the sleeve has a thickness 43 of at least 0.5 mm. In another embodiment, the sleeve has a thickness 43 of 0.5 to 1.5 mm.

[0016] In one embodiment, the sleeve length 44 is approximately 12.7 mm. In another embodiment, the length 44 is at least 6 mm. In another embodiment, the length is 4 to 500 mm. In another embodiment, the length 44 is 4 to 300 mm. In another embodiment, the length is 5 to 12 mm. In another embodiment, the length 44 is 5 to 20 mm. In another embodiment, the length 44 is 10 to 20 mm. In another embodiment, the length is 7.6 to 52 mm. In another embodiment, the length 44 is less than 20 mm. In another embodiment, the length 44 is at least 12 mm. In another embodiment, the sleeve length is 1.5 to 12 times greater than the outer diameter of the tube.

[0017] In one aspect of this disclosure, the sleeve is used to remove kinks from medical tubing. In another aspect, the provided sleeve is used to remove kinks from standard tubing in blood collection and transfusion kits. In yet another aspect, the sleeve is used to remove kinks from medical tubing selected from the group consisting of intravenous (IV) administration tubing, blood collection tubing, blood delivery tubing, and hemodialysis and peritoneal dialysis. In one aspect, the sleeve is used to prevent kinks in critical areas of the tubing (e.g., near equipment, bed frame, under the patient). In one aspect of this disclosure, the tubing includes a tubing clamp.

[0018] The size requirements for medical tubing are provided by the international standard ISO 3826. ISO 3826 requires that transport tubing have an inner diameter of 2.7 mm or more and a wall thickness of 0.5 mm or more. In one embodiment, the outer diameter of the tubing is approximately 3.7 mm. In another embodiment, the outer diameter of the tubing is approximately 4.1 mm.

[0019] In one embodiment, the inner diameter 42 of the sleeve is 0.25 to 1 mm larger than the outer diameter 41 of the tube. In another embodiment, the inner diameter of the sleeve is at least 0.1 mm larger than the outer diameter of the tube. In yet another embodiment, the inner diameter of the sleeve is up to 1 mm larger than the outer diameter of the tube. In yet another embodiment, the inner diameter of the sleeve is 0.5 to 8% larger than the outer diameter of the tube. In yet another embodiment, the inner diameter of the sleeve is less than 10% larger than the outer diameter of the tube. The relative diameter of the inner diameter 42 of the sleeve and the outer diameter 31 of the tube depends on the stiffness of the sleeve. A flexible sleeve can be slightly stretched to allow for a smaller ratio. Furthermore, the tube can also be stretched to reduce the outer diameter 31, so that the inner diameter 42 of the sleeve can be the same size as, or slightly smaller than, the (unstretched) outer diameter 31 of the tube. In yet another embodiment, the outer diameter of the tube is 4.1 mm and the inner diameter of the sleeve is 4.2 mm. In another embodiment, the outer diameter of the tube is 4.1 mm and the inner diameter of the sleeve is 4.5 mm. In one embodiment of this disclosure, the sleeve comprises two sections connected by a living hinge. A living hinge is a type of hinge fabricated from an extension of a parent material to connect two larger sections. For the entirety of this invention, see Chanbonpin, J., “Everything you need to know about living hinges (design, prototypes, and manufacturing)” (2017) (available on the internet at www.creativemechanisms.com / blog / everything-you-need-to-know-about-living-hinges), which is incorporated herein by reference. In one embodiment, the living hinge is aligned along the longitudinal axis. In another embodiment, the living hinge comprises a material selected from the group consisting of polyethylene (PE), polypropylene (PP), acrylonitrile-butadiene-styrene (ABS), or polycarbonate. In another embodiment, the living hinge comprises the same material as the sleeve. In yet another embodiment, the living hinge is a continuous piece of material.In another aspect, the living hinge is segmented along the hinge line. In yet another aspect, the length of the living hinge is equal to the longitudinal length of the sleeve. In another aspect, the length of the living hinge is less than the longitudinal length of the sleeve (Figure 5A). In a further aspect, the length of the living hinge is greater than the longitudinal length of the sleeve (Figure 5B).

[0020] In certain aspects of the present disclosure, a sleeve including a living hinge is capable of rotating more than 180 degrees. In another aspect, the living hinge includes two stops that serve to stop rotation at 180 degrees. In this case, the living hinge includes three separate pieces (triple hinge). In another aspect, the living hinge is capable of rotating from 0 to 180 degrees. In another aspect, the living hinge is capable of rotating more than 90 degrees. In another aspect, the living hinge is a butterfly living hinge. The butterfly hinge stays in its position until it moves when opened beyond a certain angle. In another aspect, the living hinge is a double hinge. The double hinge includes two narrow hinges separated by a narrow landing section. These hinges allow for 360-degree rotation.

[0021] In another aspect, the sleeve includes two sections connected by a conventional hinge. In another aspect, the conventional hinge includes multiple components.

[0022] In certain aspects of the present disclosure, the sleeve includes a clip that includes a first edge portion and a second edge portion, a lug aligned with a spring in the middle of the lug, and a pin disposed through a hole in the lug. The first edge portion is connected to the second edge portion when the spring is not actuated and separated from the second edge portion when the spring is actuated. As shown in Figure 6, when the spring is actuated, the first and second edges bend away from the grip arms.

[0023] In certain aspects of the present disclosure, the shape of the sleeve enables safe handling. In another aspect, the sleeve has an hourglass shape (FIG. 7B) that enables positioning two fingers at a smaller diameter. In another aspect, the sleeve has raised features as shown in FIG. 7C.

[0024] In certain aspects of the present disclosure, the sleeve includes an opening along its length 44 that enables the sleeve to slide over a twisted tube (FIGS. 8B-8D). In one aspect, the opening is at least as wide as the twist. In another aspect, the opening is at least twice as wide as the tube thickness 33. In another aspect, the opening is 0.9 to 2 mm. In another aspect, the opening is 0.9 to 1.1 mm. In another aspect, the opening is 1.1 to 1.5 mm. In yet another aspect, the opening is 1.5 to 2 mm. In another aspect, the opening is at least 0.9, 1.0, 1.2, 1.4, 1.5, 1.6, 1.8, or 2.0 mm. In yet another aspect, the opening is about 0.9, 1.0, 1.2, 1.4, 1.5, 1.6, 1.8, or 2.0 mm.

[0025] The methods of the present disclosure provide, and include, removing a twist in a tube, which includes sliding a sleeve having a cylindrical inner diameter along the tube. In another embodiment, the method includes heating the sleeve on the tube. In another embodiment, the heating time is 1 to 60 minutes. In another embodiment, the heating time is at least 10 minutes. In another embodiment, the method includes sliding the sleeve on the twist and allowing the sleeve to remain in place for a certain period of time. In one embodiment, the sleeve is positioned on the twist for a few seconds, a few minutes, or a few hours. In another embodiment, the sleeve is positioned on the twist for 1 to 90 minutes. In another embodiment, the sleeve is positioned on the twist indefinitely. In another embodiment, the method further includes positioning the sleeve on the twist by sliding and rotating the sleeve. In another embodiment, the sleeve is heated before it is positioned on the tube. In another embodiment, the tube is heated. In yet another embodiment, the sleeve is clamped on the twist and rotated around it.

[0026] This disclosure provides a method for restoring fluid flow within a tube, which involves removing a twist within the tube and sliding a sleeve having a cylindrical inner diameter along the tube. In one embodiment, the flow is restored to 90% of the flow before the twist was removed. In another embodiment, the flow is restored to 95% of the flow before the twist was removed. In another embodiment, the flow is restored to 97% of the flow before the twist was removed. In another embodiment, the flow is restored to 99% of the flow before the twist was removed. In yet another embodiment, the flow is restored to at least 50% of the flow before the twist was removed. In yet another embodiment, the flow is restored to at least 60% of the flow before the twist was removed. In yet another embodiment, the flow is restored to at least 70% of the flow before the twist was removed. In yet another embodiment, the flow is restored to at least 80% of the flow before the twist was removed. In yet another embodiment, the flow is restored to 100% of the flow before the twist was removed. In yet another embodiment, the flow is restored to 20-100% of the flow before the twist was removed. In some embodiments, the restoration of flow is due to ambient pressure.

[0027] In another aspect of the present disclosure, the method includes removing a twist in a tube by placing a sleeve including a living hinge over the tube containing the twist.

[0028] The method of the present disclosure provides, and includes, preventing twisting within a tube, by sliding a sleeve having a cylindrical inner diameter along the tube. In one embodiment, the sleeve protects the tube from bending.

[0029] This disclosure provides a kit comprising a blood bag connected to a tube and a sleeve screwed onto the tube.

[0030] As used herein, the term “approximately” refers to ±10%.

[0031] As used herein, the term “less than” refers to amounts less than and amounts greater than zero.

[0032] The terms "comprises," "comprising," "includes," "including," and "having," and their conjugations, all mean "including but not limited to."

[0033] The term "consisting of" means "including and limited to."

[0034] The phrase "consisting essentially of" means that a composition, method, or structure may include additional components, steps, and / or parts only if the additional components, steps, and / or parts do not substantially alter the basic and novel features of the claimed composition, method, or structure.

[0035] As used herein, the singular forms "a," "an," and "the" include multiple references unless the context explicitly indicates otherwise. For example, the terms "compound" or "at least one compound" may include multiple compounds, including mixtures thereof.

[0036] As used herein, the term “blood” refers to whole blood, leukopenic RBCs, thrombocytopenic RBCs, and leukocytes and thrombocytopenic RBCs. The term “blood” further includes packed red blood cells, thrombocytopenic packed red blood cells, leukopenic packed red blood cells, and leukocytes and thrombocytopenic packed red blood cells.

[0037] As used herein, the term “rigid” means that the sleeve is not bendable. A rigid sleeve may have a flexural modulus value greater than 2 GPa. In another embodiment, a rigid sleeve may have a flexural modulus value greater than 0.5 GPa.

[0038] As used herein, the term "semi-rigid" means that the sleeve is rigid but bends when force is applied. A semi-rigid sleeve may have a flexural modulus value of 0.1 to 0.5 GPa.

[0039] As used herein, the term "flexible" means that the sleeve can be easily bent without breaking. A flexible sleeve may have a flexural modulus value of 0.0001 to 0.1 GPa. In another embodiment, the flexible sleeve may have a flexural modulus value of less than 0.1 GPa. In yet another embodiment, the flexible sleeve may have a flexural modulus value of about 0.01 GPa.

[0040] This disclosure provides the following embodiments.

[0041] Embodiment 1. A device for restoring flow to a twisted tube, comprising a sleeve having a cylindrical inner surface larger than the outer diameter of the tube, wherein the sleeve is slidable along the tube so as to compress the twisted tube perpendicular to the twist.

[0042] Embodiment 2. The apparatus according to Embodiment 1, wherein the sleeve comprises a material selected from the group consisting of polyethylene (PE), polypropylene (PP), metal, polyethylene terephthalate (PETG), polyvinyl chloride (PVC), PC, acrylic, nylon, acrylonitrile-butadiene-styrene (ABS), polytetrafluoroethylene (PTFE or Teflon), polyvinylidene fluoride (PVDF), polyetheretherketone (PEEK), chlorinated polyvinyl chloride (CPVC), fluorinated ethylene propylene (FEP), perfluoroalkoxyalkane (PFA), polyimide, acetal, polyetherimide, and Ultem. In another embodiment, the sleeve comprises two or more materials selected from the group consisting of polyethylene (PE), polypropylene (PP), metal, polyethylene terephthalate (PETG), polyvinyl chloride (PVC), PC, acrylic, nylon, acrylonitrile-butadiene-styrene (ABS), polytetrafluoroethylene (PTFE or Teflon), polyvinylidene fluoride (PVDF), polyetheretherketone (PEEK), chlorinated polyvinyl chloride (CPVC), fluorinated ethylene propylene (FEP), perfluoroalkoxyalkane (PFA), polyimide, acetal, polyetherimide, and Ultem.

[0043] Embodiment 3. The apparatus according to Embodiment 1 or 2, wherein the tube is a medical tube selected from the group consisting of intravenous (IV) administration tubes, blood collection tubes, blood administration tubes, and hemodialysis and peritoneal dialysis tubes.

[0044] Embodiment 4. The apparatus according to any one of Embodiments 1 to 3, wherein the twisted tube further includes a tube clamp.

[0045] Embodiment 5. The apparatus according to any one of Embodiments 1 to 4, wherein the sleeve is semi-rigid.

[0046] Embodiment 6. The apparatus according to any one of Embodiments 1 to 4, wherein the sleeve has a flexural modulus value at least twice that of the twisted tube.

[0047] Embodiment 7. The apparatus according to any one of Embodiments 1 to 4, wherein the sleeve has a flexural modulus of less than 0.1 GPa.

[0048] Embodiment 8. The apparatus according to any one of Embodiments 1 to 7, wherein the inner diameter 42 of the sleeve is less than 10% larger than the outer diameter of the tube.

[0049] Embodiment 9. The apparatus according to any one of Embodiments 1 to 8, wherein the inner diameter 42 of the sleeve is 0.5 to 8% mm larger than the outer diameter 31 of the tube.

[0050] Embodiment 10. The apparatus according to any one of Embodiments 1 to 8, wherein the inner diameter 42 of the sleeve is 0.25 to 1.0 mm larger than the outer diameter 31 of the tube.

[0051] Embodiment 11. The apparatus according to any one of Embodiments 1 to 7, wherein the sleeve includes an outer diameter 41 of 6 to 18 mm.

[0052] Embodiment 12. The apparatus according to any one of Embodiments 1 to 7, wherein the sleeve includes an outer diameter 41 of approximately 6.35 mm.

[0053] Embodiment 13. The apparatus according to any one of Embodiments 1 to 8, wherein the sleeve includes an inner diameter 42 of 3 to 5 mm.

[0054] Embodiment 14. The apparatus according to Embodiment 13, wherein the sleeve includes an inner diameter 42 of approximately 4.23 mm.

[0055] Embodiment 15. The apparatus according to any one of Embodiments 1 to 14, wherein the sleeve includes a thickness 43 of at least 0.5 mm.

[0056] Embodiment 16. The apparatus according to any one of Embodiments 1 to 15, wherein the sleeve includes an outer diameter 41 that is at least 50% larger than the inner diameter.

[0057] Embodiment 17. The apparatus according to any one of Embodiments 1 to 16, wherein the sleeve includes a length of 4 to 52 mm.

[0058] Embodiment 18. The apparatus according to any one of Embodiments 1 to 16, wherein the sleeve includes a length that is 1.5 to 12 times greater than the outer diameter of the tube.

[0059] Embodiment 19. The apparatus according to any one of Embodiments 1 to 17, wherein the length is approximately 12.7 mm.

[0060] Embodiment 20. The apparatus according to any one of Embodiments 1 to 19, wherein the sleeve includes an outer surface having a feature selected from the group consisting of stippling, ribbing, and knurling.

[0061] Embodiment 21. The apparatus according to Embodiment 20, wherein the knurling process is diamond knurling or linear oblique knurling.

[0062] Embodiment 22. The apparatus according to any one of Embodiments 1 to 19, wherein the sleeve includes an outer surface having a raised feature.

[0063] Embodiment 23. The apparatus according to any one of Embodiments 1 to 22, wherein the sleeve includes an external shape selected from the group consisting of square, triangular, rectangular, cylindrical, hexagonal, equilateral, quadrilateral, pentagonal, and trapezoidal.

[0064] Embodiment 24. The apparatus according to any one of Embodiments 1 to 23, wherein the sleeve comprises two sections connected by a living hinge along the longitudinal axis.

[0065] Embodiment 25. The apparatus according to Embodiment 24, wherein at least one section is capable of rotating by an angle of 180 degrees or more.

[0066] Embodiment 26. A method for removing twisting inside a tube, comprising sliding a sleeve having a cylindrical inner diameter along the tube.

[0067] Embodiment 27. The method according to Embodiment 26, further comprising heating the sleeve on the tube.

[0068] Embodiment 28. The method according to Embodiment 26, wherein the sliding includes covering the twist with the sleeve for a period of 1 second to 1 hour.

[0069] Embodiment 29. The method according to any one of Embodiments 26 to 28, wherein the sliding includes covering the torsion for at least one hour.

[0070] Embodiment 30. The method according to any one of embodiments 26 to 29, further comprising rotating the sleeve.

[0071] Embodiment 31. The method according to any one of Embodiments 26 to 30, wherein the sleeve comprises a material selected from the group consisting of polyethylene (PE), polypropylene (PP), metal, polyethylene terephthalate (PETG), polyvinyl chloride (PVC), PC, acrylic, nylon, acrylonitrile-butadiene-styrene (ABS), polytetrafluoroethylene (PTFE or Teflon), polyvinylidene fluoride (PVDF), polyetheretherketone (PEEK), chlorinated polyvinyl chloride (CPVC), fluorinated ethylene propylene (FEP), perfluoroalkoxyalkane (PFA), polyimide, acetal, polyetherimide, and Ultem. In another embodiment, the sleeve comprises two or more materials selected from the group consisting of polyethylene (PE), polypropylene (PP), metal, polyethylene terephthalate (PETG), polyvinyl chloride (PVC), PC, acrylic, nylon, acrylonitrile-butadiene-styrene (ABS), polytetrafluoroethylene (PTFE or Teflon), polyvinylidene fluoride (PVDF), polyetheretherketone (PEEK), chlorinated polyvinyl chloride (CPVC), fluorinated ethylene propylene (FEP), perfluoroalkoxyalkane (PFA), polyimide, acetal, polyetherimide, and Ultem.

[0072] Embodiment 32. The method according to any one of Embodiments 26 to 31, wherein the tube is a medical tube selected from the group consisting of intravenous (IV) administration tubes, blood collection tubes, blood administration tubes, and hemodialysis and peritoneal dialysis tubes.

[0073] Embodiment 33. The method according to any one of embodiments 26 to 32, wherein the sleeve is semi-rigid.

[0074] Embodiment 34. The method according to any one of embodiments 26 to 32, wherein the sleeve is rigid.

[0075] Embodiment 35. The method according to any one of Embodiments 26 to 32, wherein the sleeve has a flexural modulus of less than 0.1 GPa.

[0076] Embodiment 36. The method according to any one of Embodiments 26 to 35, wherein the inner diameter 42 is larger than the outer diameter 31 of the tube.

[0077] Embodiment 37. The method according to Embodiment 36, wherein the inner diameter 42 of the sleeve is less than 10% mm larger than the outer diameter of the tube.

[0078] Embodiment 38. The method according to Embodiment 36, wherein the inner diameter 42 of the sleeve is 0.5 to 8% mm larger than the outer diameter of the tube.

[0079] Embodiment 39. The method according to Embodiment 36, wherein the inner diameter 42 of the sleeve is equal to the outer diameter of the tube.

[0080] Embodiment 40. The method according to any one of Embodiments 26 to 36, wherein the sleeve includes an outer diameter 41 of 6.35 mm.

[0081] Embodiment 41. The method according to any one of Embodiments 26 to 38, wherein the inner diameter 42 is 4.23 mm.

[0082] Embodiment 42. The method according to Embodiment 26, wherein the sleeve includes an outer diameter 41 that is at least 1.5 mm larger than the inner diameter.

[0083] Embodiment 43. The method according to any one of Embodiments 26 to 41, wherein the sleeve includes an outer diameter 41 that is at least 50% larger than the inner diameter.

[0084] Embodiment 44. The method according to any one of Embodiments 26 to 43, wherein the sleeve includes a length of 4 to 52 mm.

[0085] Embodiment 45. The method according to any one of Embodiments 26 to 43, wherein the sleeve includes a length that is 1.5 to 12 times greater than the outer diameter of the tube.

[0086] Embodiment 46. The method according to any one of embodiments 26 to 43, wherein the sleeve includes a length that is 1.5 to 12 times greater than the outer diameter of the tube.

[0087] Embodiment 47. The method according to Embodiment 44, wherein the sleeve includes a length of approximately 12.7 mm.

[0088] Embodiment 48. The method according to any one of embodiments 26 to 47, wherein the sleeve includes an outer surface having features selected from the group consisting of stippling, ribbing, and knurling.

[0089] Embodiment 49. The method according to any one of Embodiments 26 to 48, wherein the knurling process is diamond knurling or straight oblique knurling.

[0090] Embodiment 50. The method according to any one of Embodiments 26 to 49, wherein the sleeve includes an outer surface having a raised feature.

[0091] Embodiment 51. The method according to any one of Embodiments 26 to 50, wherein the sleeve includes an external shape selected from the group consisting of square, triangular, rectangular, cylindrical, hexagonal, equilateral, quadrilateral, pentagonal, and trapezoidal.

[0092] Embodiment 52. The method according to any one of Embodiments 26 to 51, wherein the sleeve includes an inner diameter with a chamfer.

[0093] Embodiment 53. A device for restoring flow to a twisted tube, comprising a sleeve having a cylindrical inner surface less than or equal to the outer diameter of the tube, wherein the sleeve is capable of compressing the twisted tube perpendicular to the twist.

[0094] Embodiment 54. The apparatus according to Embodiment 53, wherein the sleeve comprises a material selected from the group consisting of polyethylene (PE), polypropylene (PP), metal, polyethylene terephthalate (PETG), polyvinyl chloride (PVC), PC, acrylic, nylon, acrylonitrile-butadiene-styrene (ABS), polyethylene (PE), polypropylene (PP), metal, polyethylene terephthalate (PETG), polyvinyl chloride (PVC), PC, acrylic, nylon, acrylonitrile-butadiene-styrene (ABS), polytetrafluoroethylene (PTFE or Teflon), polyvinylidene fluoride (PVDF), polyetheretherketone (PEEK), chlorinated polyvinyl chloride (CPVC), fluorinated ethylene propylene (FEP), perfluoroalkoxyalkane (PFA), polyimide, acetal, polyetherimide, and Ultem. In another embodiment, the sleeve comprises two or more materials selected from the group consisting of polyethylene (PE), polypropylene (PP), metal, polyethylene terephthalate (PETG), polyvinyl chloride (PVC), PC, acrylic, nylon, acrylonitrile-butadiene-styrene (ABS), polytetrafluoroethylene (PTFE or Teflon), polyvinylidene fluoride (PVDF), polyetheretherketone (PEEK), chlorinated polyvinyl chloride (CPVC), fluorinated ethylene propylene (FEP), perfluoroalkoxyalkane (PFA), polyimide, acetal, polyetherimide, and Ultem.

[0095] Embodiment 55. The apparatus according to Embodiment 53, wherein the tube is a medical tube selected from the group consisting of intravenous (IV) administration tubes, blood collection tubes, blood administration tubes, and hemodialysis and peritoneal dialysis tubes.

[0096] Embodiment 56. The apparatus according to Embodiment 53, wherein the twisted tube further includes a clamp.

[0097] While this disclosure has been described in relation to specific embodiments, those skilled in the art will understand that various modifications can be made and equivalents can be substituted for their elements without departing from the scope of this disclosure. In addition, many modifications can be made to adapt the teachings of this disclosure to specific circumstances or materials without departing from the scope of this disclosure.

[0098] Accordingly, this disclosure is not intended to be limited to any particular embodiment disclosed as the best form intended for carrying out this disclosure, but it includes all embodiments that fall within the scope and spirit of the appended claims. [Examples]

[0099] Example 1: Manufacturing and removal of tube twists To create the twist, screw pieces of PVC tubing that meet the ISO 3826 size requirements through plastic clamps (Halkey-Roberts #C340TCSPX). Close the clamps and heat the tubing with a heat shrink gun to exacerbate the twist in the PVC tubing caused by the clamps.

[0100] A piece of Poly-Flo® semi-rigid polyethylene tubing, with an outer diameter of approximately 6.35 mm, an inner diameter of approximately 4.32 mm, and a length of 12.7 mm, is placed on top of the PVC tubing near the clamp (Figure 2). The clamp is removed, leaving a twist in the tubing. The tubing is unusable due to the reduced inner diameter and limited internal fluid flow (Figures 3A and 3B).

[0101] The twist is removed by sliding the sleeve over the twist (Figures 4A and 4B), compressing the tube perpendicular to the twist, and restoring the flow.

Claims

1. A blood transfusion and blood collection kit comprising a blood bag connected to a medical tube and a rigid, non-flexible sleeve screwed onto the medical tube, wherein the medical tube is easily bent, the non-flexible sleeve has an outer shape, an outer diameter (41), an inner diameter (42), a thickness (43), a length (44), and an inner cylindrical surface, the inner diameter (42) being less than 10% larger than the outer diameter (31) of the medical tube, the non-flexible sleeve is for removing any bends that may form in the medical tube during use of the kit and restoring fluid flow within the medical tube by sliding the non-flexible sleeve along the medical tube in a direction perpendicular to the bend, the flexural modulus of the non-flexible sleeve is greater than 2 gigapascals (GPa), the flexural modulus is the stress-to-strain ratio of the non-flexible sleeve material, and the outer shape is selected from the group consisting of square, triangle, rectangle, cylinder, hexagon, equilateral, quadrilateral, pentagon, and trapezoid.

2. The kit according to claim 1, wherein the medical tube is selected from the group consisting of a blood collection tube and a blood administration tube.

3. The kit according to claim 1, further comprising a tube clamp.

4. The kit according to claim 1, wherein the outer shape of the non-flexible sleeve is cylindrical.

5. The kit according to claim 1, wherein the flexural modulus of the non-flexible sleeve is twice or more the flexural modulus of the medical tube.

6. A blood collection and transfer device for use in transfusion medicine, wherein the device comprises: i. Flexible medical tubes, and ii. A non-flexible sleeve for eliminating kinks that may occur in the medical tube while the device is in use, The non-flexible sleeve has an outer shape, an outer diameter (41), an inner diameter (42), a thickness (43), a length (44), and a cylindrical inner surface, wherein the inner diameter (42) is less than 10% larger than the outer diameter (31) of the medical tube, the non-flexible sleeve is slidable along the medical tube, the bending is removed and the fluid flow in the medical tube is restored when the non-flexible sleeve is slid along the medical tube perpendicular to the bending formed in the medical tube during use of the device, the bending modulus of the non-flexible sleeve is greater than 2 gigapascals (GPa), the bending modulus is the ratio of stress to strain of the non-flexible sleeve material, and the outer shape is selected from the group consisting of square, triangle, rectangle, cylinder, hexagon, equilateral, quadrilateral, pentagon, and trapezoid.

7. The apparatus according to claim 6, wherein the non-flexible sleeve comprises a material selected from the group consisting of polyethylene (PE), polypropylene (PP), metal, polyethylene terephthalate (PETG), polyvinyl chloride (PVC), PC, acrylic, nylon, acrylonitrile butadiene styrene (ABS), polytetrafluoroethylene (PTFE or Teflon), polyvinylidene fluoride (PVDF), polyether ether ketone (PEEK), chlorinated polyvinyl chloride (CPVC), fluorinated ethylene propylene (FEP), perfluoroalkoxyalkane (PFA), polyimide (PI), acetal, polyetherimide (PEI), and any combination thereof.

8. The apparatus according to claim 6, wherein the medical tube is selected from the group consisting of a blood collection tube and a blood administration tube.

9. The apparatus according to claim 6, further comprising a tube clamp.

10. The apparatus according to claim 6, wherein the outer diameter (41) of the non-flexible sleeve is 6 to 18 millimeters (mm).

11. The apparatus according to claim 6, wherein the inner diameter (42) of the non-flexible sleeve is 3 to 5 millimeters (mm).

12. The apparatus according to claim 6, wherein the outer shape of the non-flexible sleeve is further characterized by being selected from the group consisting of stippling, ribbing, and knurling.

13. The apparatus according to claim 12, wherein the knurling process is diamond knurling or linear oblique knurling.

14. The apparatus according to claim 6, wherein the outer shape of the non-flexible sleeve further includes a raised feature.

15. The apparatus according to claim 6, wherein the outer shape of the non-flexible sleeve is cylindrical.

16. The apparatus according to claim 6, wherein the non-flexible sleeve has an opening along the length (44) of the non-flexible sleeve.

17. The apparatus according to claim 6, wherein the non-flexible sleeve has a flexural modulus value at least twice that of a bent medical tube.

18. The apparatus according to claim 6, wherein the thickness of the non-flexible sleeve is at least 0.5 millimeters (mm).

19. The apparatus according to claim 6, wherein the length of the non-flexible sleeve is 4 to 52 millimeters (mm).

20. The apparatus according to claim 6, wherein the bend includes a fold in the medical tube.

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