VALVE COMPONENT AND VALVE ASSEMBLY

Abstract

The present invention relates to a valve component for a medical valve assembly, the valve component comprising a deformable body for location in a valve assembly housing, the deformable body comprising a conduit for receiving one or more medical instruments there-through, one or more helical grooves being formed on a surface of the conduit, the one or more helical grooves extending into the deformable body from the conduit surface.

Claims

1. A valve component for a medical valve assembly, the valve component comprising: a deformable body for location in a valve assembly housing, the deformable body comprising a conduit for receiving one or more medical instruments there-through, one or more helical grooves being formed on a surface of the conduit, the one or more helical grooves extending into the deformable body from the conduit surface.

2. The valve component of claim 1, wherein the conduit extends from a proximal end of the body to a distal end of the body, the one or more helical grooves extending into said deformable body from the conduit surface to define one or more helical contact surfaces for contacting one or more medical instruments located in the conduit.

3. The valve component of claim 1, wherein a plurality of helical grooves is provided on the conduit surface.

4. The valve component of claim 1, wherein three helical grooves are provided on the conduit surface.

5. The valve component of claim 1, wherein the deformable material has a shore hardness ‘A’ of 5 to 20.

6. The valve component of claim 1, wherein the valve component is for use in a haemostatic valve.

7. The valve component of claim 1, wherein the pitch of one or more of said one or more helical grooves is in the range 2 to 10 mm.

8. The valve component of claim 1, wherein helical vane diameter of the one or more helical grooves is in the range 2 to 10 mm.

9. A valve assembly comprising the valve component of claim 1, further comprising a valve assembly housing, wherein the housing is adapted to put the deformable body into a compressed state.

10. The valve assembly of claim 9, wherein the deformable body has outer dimensions oversized by 1 to 15% relation to the housing.

11. The valve assembly of claim 9, wherein the body and housing are each cylindrical, with the external diameter of the body being 1 to 15% greater than that of the internal diameter of the housing.

12. The valve assembly of claim 9, wherein the deformable body is a first deformable body, a second deformable body being provided having a conduit for receiving said one or more medical instruments there-though, the conduits of the first and second deformable bodies having a common axis.

13. The valve assembly of claim 12, wherein the conduit of the second deformable body has a widened opening at an introduction end for enhancing introduction of said one or more medical instruments.

14. The valve assembly of claim 12, wherein the conduit of the second deformable body has a tapered opening at an introduction end for enhancing introduction of said one or more medical instruments.

15. The valve assembly of claim 12, wherein, the first and second deformable bodies abut one other within the housing, with their conduits aligned.

16. The valve assembly of claim 9, wherein the walls of the valve assembly housing and/or the deformable body are tapered to allow variable compression of the deformable body on movement of the deformable body within the housing.

17. The valve assembly of claim 9, further comprising a purse string suture for opening and closing the valve.

Description

FIGURES

[0023] Certain preferred embodiments of the present invention will now be described by way of example and with reference to FIGS. 1 to 8 of the drawings, of which:—

[0024] FIG. 1 shows in a sectional view of a valve assembly having a valve component of the present invention;

[0025] FIG. 2 shows an exploded view of the valve assembly components of FIG. 1;

[0026] FIG. 3 shows a part cross-sectional view of the valve assembly of FIGS. 1 and 2;

[0027] FIG. 4 shows a perspective view of a triple helix core corresponding to triple helix grooves provided around a conduit in a deformable body of the present invention of FIGS. 1 to 3;

[0028] FIGS. 5A, 5B and 5C show single, double and triple helix variants of the present invention;

[0029] FIG. 6 shows a schematic view of the forces at play on insertion of one or more medical instruments with the valve component of the present invention;

[0030] FIG. 7 shows a variant of a valve assembly having a valve component according to a further embodiment of the present invention; and

[0031] FIG. 8 shows a variant of a tapered valve body according to a further embodiment of the present invention.

DETAILED DESCRIPTION OF THE FIGURES

[0032] The present invention relates to valves for use in medical applications and more particularly to haemostatic valves used in endovascular procedures.

[0033] In this connection and as shown in FIGS. 1 to 3, the invention concerns a first deformable body 1 retained within a housing 2 that also preferably houses a second deformable body 3. The first and second deformable bodies may be oversized with respect to the housing so that when inserted within the housing they are in a state of compression. In this regard, the housing comprises a cylindrical body section for retaining the first and second deformable bodies, the diameters of the bodies being oversized by 1 to 15% with regard to the diameter of the cylindrical body section. The deformable bodies are formed of liquid moulded silicon, although any suitable alternative compliant materials, such as rubber, may be used.

[0034] An end cap 4 threadingly engages an open end of the housing 2 to close off the assembly 10 formed by the housing, deformable bodies and end cap.

[0035] The end cap 4 has an aperture 5 allowing access of one or more medical instruments, such as a catheter (not shown) into the housing. An opposite end of the housing has a similar opening 6 allowing the one or more medical instruments to pass through the assembly, into for example an introducer sheath mounted at this end of the housing.

[0036] As shown in FIG. 3, the two deformable bodies 1, 3 each have a preformed conduit 7, 8, the conduits being aligned with the axis passing through apertures 5, 6. The conduits 7, 8 have a cross-section that is dimensioned to be slightly undersized with respect to the cross-section of the medical instrument to be used with the assembly so that the deformable bodies seal around the one or more medical instruments when pushed through the assembly. A typical needle valve might have a diameter of 1.2 mm such that the conduit diameter would be marginally less. Of course, the dimensions of the valve components may be varied to suit the requirements of the instruments with which they are being used.

[0037] The first deformable body 1 has one or more helical grooves 9 formed in the conduit surface defining helical contact surfaces 16 for engaging longitudinally along the one or more medical instruments passing through the assembly. The one or more helical grooves are preformed into the material of the first deformable body. The one or more helical grooves may have a helical vane diameter in the range of 2 to 10 mm. In certain preferred embodiments, the one or more helical grooves extend to a diameter of up to 6 mm or more preferably 5.6 mm about the central axis of the conduit through the deformable body. The one or more helical grooves moreover extend longitudinally along a major portion of the first deformable body.

[0038] As shown in FIG. 6, the inclination resulting from the helix configuration of the one or more grooves 9 means that on insertion of the one or more medical instruments, a longitudinal compression is applied to the first deformable body 1, which causes helical voids and gaps to close, therefore sealing the flow path through the valve assembly.

[0039] In this regard, the pitch of the helical grooves is preferably in the range of 2 to 10 mm, and more preferably 3 mm.

[0040] In certain preferred embodiments, the helical vane diameter is in the range 2 to 10 mm and more preferably 5.6 mm.

[0041] In the preferred embodiments, three helical grooves are provided, as shown in FIGS. 4 and 5A. Each of said grooves preferably has a helical vane diameter in the range of 2 to 10 mm and preferably 5.6 mm and a pitch in the range of 2 to 10 mm and preferably 3 mm.

[0042] FIGS. 5A, 5B and 5C in this respect show triple, double and single helix variants.

[0043] The one or more helical grooves may have a width of 0.8 mm to 2.0 mm.

[0044] It is intended that one size of the valve assembly can offer sealing from wire entry up to a 23Fr OD Anaconda® delivery sheath.

[0045] Whilst the above described valve assembly incorporates a passive valve component, in certain circumstances, it may be necessary to refine the sealing properties of the assembly, for example for a surgeon to control back flow leakage. FIG. 7 shows a variant of a valve component according to a further embodiment of the present invention where the deformable body 1 has a purse string sealing arrangement to enable refinement of the sealing properties of the assembly.

[0046] FIG. 8 shows a further variant of a valve assembly where the inward facing walls 11 of the housing are tapered, as are the outer surface walls of the first deformable body 1. In this way, by moving the first deformable body relative to the walls 11, the strength of compression of the deformable body 1 can be increased and decreased, thereby varying the sealing properties of the assembly.

[0047] In preferred embodiments, the enhanced sealing properties afforded by the valve assembly allow it to accommodate multiple catheter insertions simultaneously.