SELF-SEALING CATHETER VALVE

Abstract

A self-sealing catheter valve that includes a flexible tubular part having a distal opening and an opposite proximal opening, and a proximal valve part. The proximal valve part has a curved self-sealing flexible diaphragm disposed inside the flexible tubular part and has a base perimeter united with a circumferential wall of the flexible tubular part. The curved self-sealing flexible diaphragm has a concave surface facing towards the proximal opening, and a convex surface facing towards the distal opening, and a flexible diaphragm wall of the curved self-sealing flexible diaphragm has a traverse slit. The self-sealing catheter valve provides an efficient self-closing mechanism for a peripheral catheter assembly and constitutes an efficient barrier against potential contagious spread from the patient to the surrounding environment by blood born disease e.g. HIV, hepatitis and Ebola viruses.

Claims

1.-15. (canceled)

16. A self-sealing peripheral catheter valve including: a flexible tubular part having a distal opening and an opposite proximal opening, and a proximal valve part that has a curved self-sealing flexible diaphragm disposed inside the flexible tubular part and has a base perimeter united with a circumferential wall of the flexible tubular part, wherein the curved self-sealing flexible diaphragm has a concave surface facing towards the proximal opening and a convex surface facing towards the distal opening, and wherein a flexible diaphragm wall the curved self-sealing flexible diaphragm has a traverse slit, wherein the convex surface of the curved self-sealing flexible diaphragm has an upright rib extending crosswise the traverse slit towards the interior surface of the circumferential wall of the flexible tubular part, and wherein the curved self-sealing flexible diaphragm is adapted to fluid-tight seal around a male Luer inserted via the traverse slit.

17. The self-sealing peripheral catheter valve according to claim 16, wherein the proximal valve part comprises an annular skirt or rim defining or including the base perimeter, which annular skirt or rim opposite the base perimeter extends into the curved self-sealing flexible diaphragm, optionally wherein the annular skirt or rim is defined by a length of the flexible tubular part, and further optionally the rim is the base perimeter.

18. The self-sealing peripheral catheter valve according to claim 16, wherein the traverse slit extends at least 60% or at least 70% across the curved self-sealing flexible diaphragm.

19. The self-sealing peripheral catheter valve according to claim 16, wherein the upright rib merges into the circumferential wall of the flexible tubular part inside said flexible tubular part, or a clearance is delimited between the upright rib of the self-sealing flexible diaphragm and the interior surface of the circumferential wall of the flexible tubular part.

20. The self-sealing peripheral catheter valve according to claim 16, wherein an exterior surface of the circumferential wall of the flexible tubular part has at least two protuberances, optionally positioned diametrical opposite each other on a line taken through the upright diametrical rib of the curved self-sealing flexible diaphragm.

21. The self-sealing peripheral catheter valve according to claim 16, wherein the proximal opening has an annular flange, optionally with the exterior diameter of the annular flange being larger than the exterior diameter of the flexible tubular part.

22. The self-sealing peripheral catheter valve according to claim 16, wherein one or both of the flexible tubular part and the curved self-sealing flexible diaphragm has a circular, oblong, or oval interior cross-section, and/or a circular, oblong or oval exterior cross-section.

23. The self-sealing peripheral catheter valve according to claim 16, wherein the flexible tubular part has one or more of: a length selected to pass below an injection port of a peripheral catheter assembly or hub, wherein the center axis of the injection port traverses the longitudinal axis of the self-sealing peripheral catheter valve, optionally with the center axis of the injection port traversing the longitudinal axis of the self-sealing peripheral catheter valve substantially perpendicularly, or a cross-section selected so that the circumferential wall engages the channel inside which the self-sealing peripheral catheter valve is mounted.

24. The self-sealing peripheral catheter valve according to claim 16, wherein the largest distance from the base perimeter to the bottom of the concave surface of the curved self-sealing flexible diaphragm is less than or equal to 25%, less than or equal to 20% or less than or equal to 17% of the total distance between the base perimeter and the distal opening.

25. The self-sealing peripheral catheter valve according to claim 16, wherein the depth of the curved self-sealing flexible diaphragm is substantially equal to the axial distance of the annular skirt or rim, optionally with the depth of the self-sealing flexible diaphragm being about 5% larger than the axial distance of the annular skirt.

26. The self-sealing peripheral catheter valve according to claim 16, wherein the entire proximal valve part is accommodated inside the flexible tubular part.

27. The self-sealing peripheral catheter valve according to claim 16, wherein the wall thickness of the circumferential wall of the flexible tubular part decreases towards the distal opening.

28. The self-sealing peripheral catheter valve according to claim 16, which is configured to open in response to inserting an object along the longitudinal axis of the self-sealing peripheral catheter valve and to close automatically when the object is removed.

29. A peripheral catheter assembly comprising the self-sealing peripheral catheter valve according to claim 16.

Description

[0042] The invention will be described below in further details with reference to the drawing in which

[0043] FIG. 1 is a perspective view of a first embodiment of a self-sealing catheter valve seen oblique from the proximal end,

[0044] FIG. 2 is a sectional view taken along line II-II of FIG. 1,

[0045] FIG. 3 shows, in perspective, half of a self-sealing catheter valve, obtained by an axial cut through the traverse slit,

[0046] FIG. 4 is a sectional axial view taken in a plane through the traverse slit,

[0047] FIG. 5 shows, similar to FIG. 3, the self-sealing catheter valve but intersected along an axial sectional line offset towards the circumferential wall of the tubular part,

[0048] FIG. 6 shows a cross-section taken through the plane of the protuberances,

[0049] FIG. 7 is a transparent view of the self-sealing catheter valve seen in FIG. 1 oblique from the side,

[0050] FIG. 8 shows a second embodiment of a self-sealing catheter valve seen from the proximal opening, and

[0051] FIG. 9a shows a longitudinal sectional view of a catheter valve including a flexible tubular part and a proximal valve part in form of a conventional cross slit valve,

[0052] FIG. 9b shows, in perspective from the proximal end obliquely inside the catheter valve of FIG. 9a, the proximal valve part of said catheter valve,

[0053] FIG. 9c shows the catheter valve seen in FIG. 9a from the distal end,

[0054] FIG. 10a shows a longitudinal sectional view of a catheter valve including a flexible tubular part and a proximal valve part in form of a conventional multi-slotted dome valve,

[0055] FIG. 10b shows the catheter valve of FIG. 10a from the proximal end,

[0056] FIG. 10c shows the catheter valve seen in FIG. 10a from the distal end,

[0057] FIG. 11a shows a longitudinal sectional, perspective, view of a catheter valve including a flexible tubular part and a proximal valve part in form of a conventional aortic valve shape, and

[0058] FIG. 11b shows the catheter valve seen in FIG. 11a from the distal end.

[0059] FIG. 1 is a perspective view of a first embodiment of a self-sealing catheter valve 1 according to the present invention. The self-sealing catheter valve 1 has a flexible tubular part 2 with a proximal end part 3 that extends into a distal end part 4. A proximal valve part 5 is arranged inside the flexible tubular part 2 closer to the proximal end part 3 than to the distal end part 4, thereby enabling at least the distal end part 4 to pass below an injection port (not shown) of a catheter hub (not shown) to also serve as an injection valve 4 for the injection port.

[0060] The distal end part 4 of the flexible tubular part 2 has a distal opening 6 through which infusion liquid can pass further into the catheter and the blood vessel, and via which distal opening 6 back flow of blood via the inserted catheter can enter the self-sealing catheter valve 1 to reach the proximal valve part 5.

[0061] The proximal valve part 5 has a curved self-sealing flexible diaphragm 7 disposed inside the flexible tubular part 2. The proximal valve part 5 has a base perimeter 8 united with a circumferential wall 9 of the flexible tubular part 2 so that the curved self-sealing flexible diaphragm 7 protrudes towards the distal opening 6.

[0062] The curved self-sealing flexible diaphragm 7 has a concave surface 11 facing towards the proximal opening 12, and a convex surface 10 facing towards the opposite distal opening 6 of the distal end part 4. The proximal end part 3 has a flange 13 terminating the proximal opening 12. The wall 14 of the curved self-sealing flexible diaphragm 7 of the proximal valve part 5 has a traverse slit 15 to allow passage of objects such as an inserted catheter or a male Luer (not shown), around which the traverse slit 15 conforms to seal tightly. A short annular skirt 20 is provided as a short length of circumferential wall of the proximal end part 3 and extends into the flange 13.

[0063] An upright rib 16 is provided on the convex surface 10 of the wall 14 of the curved self-sealing flexible diaphragm 7. The upright rib 16 is arranged substantially perpendicular to the traverse slit 15 so as to divide the traverse slit 15 into two opposite upright flexible fins 16a,16b. The ends 17a,17b of the fins 16a,16b may be joined to the circumferential wall 9 of the flexible tubular part 2 or be free to flex in engagement with the circumferential wall 9 of the flexible tubular part 2. Two opposite protuberances 18a,18b or beads are provided aligned with the ends of the upright rib 16 on the exterior surface of the circumferential wall 9 of the flexible tubular part 2. When an object is inserted in the traverse slit 15 it presses the ends of the two opposite upright flexible fins 16a,16b against the flexible tubular wall 2 and thus also on the respective protuberances 18a,18b, to engage the rigid wall of a catheter hub wherein the self-sealing catheter valve 1 is inserted. This way is created compressive forces that make the traverse slit 15 to close and seal tightly around the object, and so that when the object is removed the traverse slit 15 automatically closes, simply by virtue of releasing compressive forces and tension previously provided to the proximal valve part 5 by the inserted object.

[0064] FIG. 4 is a sectional axial view of FIG. 1 taken in a plane through the traverse slit 15 to illustrate the curvature of the curved self-sealing flexible diaphragm 7. The base perimeter 8 is seen joined to the circumferential wall 9 of the flexible tubular part 2.

[0065] FIG. 5 shows, similar to FIG. 3, the self-sealing catheter valve 1 intersected along a sectional line offset towards the circumferential wall 9 of the flexible tubular part 2 to illustrate that that the curved self-sealing flexible diaphragm 7 has a certain thickness, e.g. similar to the thickness of the circumferential wall 9 of the proximal end part 3 of the flexible tubular part 2, or slightly thicker, and that the upright fins 16a,16b merge into the curvature of the convex surface 10 of the curved self-sealing flexible diaphragm 7 in front of respective protuberances 18a,18b.

[0066] FIG. 6 shows a cross-section taken through the plane of the protuberances, and thus also through the top of the convex surface 10.

[0067] FIG. 7 is a transparent view of the self-sealing catheter valve to visualize the curvature of the curved self-sealing flexible diaphragm 7 and it's attachment inside the flexible tubular part 2. FIG. 7 otherwise corresponds to FIG. 1.

[0068] FIG. 8 shows a second embodiment of a self-sealing catheter valve 19 seen from the proximal opening 12. The second embodiment 19 only differs from the first embodiment 1 in that the cross-section is oblong instead of substantially circular, so for like parts same reference numerals are used. Thus the second embodiment of a self-sealing catheter valve 19 has a major diameter greater than the minor diameter.

[0069] When the second embodiment 19 is inserted in a catheter hub having a circular cross-section the mismatch between respective cross-sections forces the self-sealing catheter valve 19 to conform to circular tubular shape, thereby obtaining an inherent frictional engagement that, on the one hand prevents dislocation upon manipulation of the catheter, and on the other hand, since the major diameter of the oblong cross-section is greater than the internal diameter of the catheter hub, keeps and forces the edges of the traverse slit 15 tight together as a result of the pressure exerted on the protuberances and the upright rib by the catheter hub wall.

[0070] For arrangement and positioning of the self-sealing catheter valve 1,19 according to the present invention in a catheter hub, references are made to applicant's international patent application no. WO 2009 016184, which arrangement, positioning and catheter assembly are incorporated by reference in the present application.

[0071] Comparative catheter valves are shown in the followings FIGS. 9a,9a,9b,10a,10b,10c,11a,11b. These catheter valves differ from the valves 1,19 of the present invention in having different proximal valve parts.

[0072] The comparative catheter valve 20 seen in FIGS. 9a,9b,9c has a proximal valve part in form of a conventional cross-slit valve 21.

[0073] The comparative catheter valve 22 seen in FIGS. 10a,10b,10c has a proximal valve part in form of a conventional multi-slotted dome valve 23.

[0074] The comparative catheter valve 24 seen in FIGS. 11a,11b has a proximal valve part in form of a conventional aortic valve shape.

Comparison Example

[0075] Catheter valves having flexible tubular parts and different conventional proximal valve parts were produced, compared and tested under various conditions on different subjects following the below valve testing protocol: [0076] In vitro short-term [0077] Fluid pressure 30 mmHg [0078] In vitro long-term, after 6 month storage [0079] Fluid pressure 30 mmHg [0080] In vitro after gamma-sterilization [0081] Fluid pressure 30 mm Hg [0082] Animal test in pigs, n=10 [0083] Blood pressure 70 mmHg [0084] Human evaluation, sterilized product, n=10 [0085] Venous blood pressure 50 mmHg

[0086] The results of the tests are shown in the Table below, where also a simple split septum valve, such as a split septum valve described in WO 2009 016184, applied in a flexible tubular part were subjected to tests.

TABLE-US-00001 Lab test Lab test Lab test after ster- Animal Human, short term, long term, ilization, test pigs sterile Valve n = 20, n = 20, n = 20, n = 10, n = 10, design % leakage % leakage % leakage % leakage % leakage Split Septum 80% 100%  (not shown) Cross slit 10% 15% 15% valve (FIGS. 9a, 9b9c) 3D-dome  0% 10% 10% 15% 30% valve (FIGS. 10a, 10b, 10c) Aortic valve 15% 30% shape (FIGS. 11a, 11b) Self-sealing  0%  0%  0%  0%  0% valve (invention)

[0087] The comparative study reveals the superior sealing properties of the self-sealing catheter valve according to the present invention in that under all test conditions and in all test environments no leakage was seen.

[0088] Preferred polymeric materials for manufacturing the self-sealing catheter valve according to the present invention include but is not limited to the liquid silicone rubbers of the SILPURAN® 6600 series obtainable from Wacker Chemie AG, Hans-Seidel-Platz 4, 81737 Munchen, Germany, e.g. SILPURAN® 6600/50 A/B.

[0089] The self-sealing catheter valve according to the present invention provides an efficient self-closing mechanism for a peripheral catheter assembly and constitutes an efficient barrier against potential contagious spread from the patient to the surrounding environment by blood born disease e.g. HIV, hepatitis and Ebola viruses.

[0090] Furthermore, the self-sealing catheter valve according to the present invention makes venipuncture must easier than hitherto known, providing the physician with a freedom to leave the patient after puncture. No blood flows unintended out of the peripheral catheter when no male part is inserted through the traverse slit and nothing enters inside the blood stream since the catheter hub always is either sealed or plugged.

[0091] The self-sealing catheter valve according to the present inventions provides an optimum protection of personal from blood spillage and blood born contamination from the patient.

[0092] So the combination of the flexible tubular part sealing the injection port and the design of the curved self-sealing flexible diaphragm preventing blood leakage when the catheter is positioned in the pressurized blood vessel is unique to the present invention. Previous designs with a simple split septum or valve constructions, such as duck-bill valve or other valve constructions, have suffered from defects in the coaptation of the split septum rims or valve edges due to malformation of these parts from the steel needle positioned over time and after sterilization procedure.