Valve components and valve assemblies

Abstract

The present invention relates to a valve component for a medical valve assembly (10), comprising a deformable body (1) for positioning within a valve assembly housing, said deformable body having a conduit therein for accommodating one or more medical devices, and one or more helical grooves (9) formed in a surface of said conduit, said one or more helical grooves extending from the conduit surface within the deformable body. [Selected figure] Figure 3

Description

Technical Field

[0001] The present invention relates to valve components and valve assemblies for medical use, and more particularly to a hemostatic valve assembly for use with vascular introducer sheaths, catheters, etc. in medical procedures.

Background Art

[0002] In this regard, hemostatic valves are used to prevent the accidental outflow or inflow of fluid to the target site of the body, and generally define a through passage that can accommodate an elongated medical device such as a catheter under hemostatic seal conditions. It has a housing.

[0003] Valves of this nature are used in a wide range of surgical procedures, and such procedures are becoming increasingly complex, including multiple exchanges of guidewires, catheters, and delivery systems.

[0004] Current hemostatic valves are generally divided into two basic categories: passive types and active types. To form a desired fluid-tight seal, passive valves generally rely on an elastic sealing body that is deformed by a medical device when the medical device is inserted into the valve. In contrast, active valves include means that require activation by a user, typically a surgeon, to move the sealing body into contact with the medical device being inserted.

Summary of the Invention

Problems to be Solved by the Invention

[0005] Although various passive hemostatic valves have been proposed in the past, a common problem with these is that, despite such multiple exchanges, the insertion force and friction against the insertion and removal movement of the catheter become excessive in order to obtain a highly reliable seal that continues to seal without leakage, which can potentially damage the instrument being used and cause harm to the patient.

[0006] Active valves address this problem by having a mechanism that allows the tightness of the sealing component to be loosened during insertion and removal. However, such valves are more complex and expensive to manufacture and require extra operating steps for medical staff, which can delay procedures and require more training.

[0007] The objective of this invention is to alleviate known problems associated with valves. [Means for solving the problem]

[0008] According to the present invention, a valve component for a medical valve assembly is provided, the valve component comprising a deformable body for positioning within the valve assembly housing, the deformable body having a conduit for housing one or more medical instruments internally, and one or more helical grooves formed on the surface of the conduit, the one or more helical grooves extending from the conduit surface into the deformable body. In this way, the valve component provides a more reliable sealing configuration with relatively small insertion force for the medical instrument used.

[0009] Preferably, the conduit extends from the base end to the terminal end of the body, and the one or more helical grooves extend from the conduit surface into the deformable body to define one or more helical contact surfaces for contacting one or more medical devices placed in the conduit. In use, the helical contact surfaces are biased to contact one or more medical devices placed in the conduit. The inclination of the helical grooves around the conduit axis is such that it can close off any voids in the grooves when longitudinal compression occurs due to the insertion of one or more medical devices. This improves flow sealing within the deformable body.

[0010] Conveniently, multiple helical grooves are defined on the contact surface. Preferably, three helical grooves are defined on the contact surface.

[0011] In a preferred embodiment, the deformable material has a Shore A hardness of 5 to 20. Such a Shore hardness parameter results in advantageous elasticity.

[0012] Preferably, the valve component is used as a hemostatic valve.

[0013] Conveniently, the pitch of the one or more helical grooves is within the range of 2 to 10 mm. Such a pitch results in improved sealing characteristics.

[0014] The diameter of the helical vanes of the one or more helical grooves is preferably in the range of 2 to 10 mm. Such vane diameters provide improved sealing properties and facilitate access to the conduit.

[0015] According to another aspect of the present invention, a valve assembly comprising the valve components described above is provided, the valve assembly further comprising a valve assembly housing, the housing being able to compress the deformable body. A slight over-dimension of the deformable body relative to the housing is set to create an appropriate bias within the body to seal the void and prevent leakage.

[0016] Preferably, the deformable body has an outer dimension that is 1 to 15% larger than that of the housing. Conveniently, the body and the housing are both cylindrical, and the outer diameter of the body is 1 to 15% larger than the inner diameter of the housing.

[0017] The deformable body is a first deformable body, and a second deformable body is provided, which has a conduit for housing one or more medical instruments, and the conduits of the first and second deformable bodies have a common axis. The second deformable body further improves the sealing of the assembly and assists in guiding one or more medical instruments into the first deformable body.

[0018] Preferably, the conduit of the second deformable body has an expanding opening at the entry end to facilitate the introduction of the one or more medical instruments. The opening may have a bowl-shaped guide surface with tapered sides, for example, to facilitate and reliable assistance for the user to introduce one or more medical instruments into the valve assembly.

[0019] Conveniently, the first and second deformable bodies abut each other within the housing so that their conduits are aligned.

[0020] Preferably, the walls of the valve assembly housing and / or the deformable body are tapered to allow for variable compression of the deformable body as it moves within the housing. In this way, the sealing characteristics can be refined as needed.

[0021] Conveniently, the valve assembly further includes a drawstring suture for opening and closing the valve. In this way, the sealing characteristics of the deformable body can be controlled as needed.

[0022] Some preferred embodiments of the present invention will be described below with reference to Figures 1 to 8. [Brief explanation of the drawing]

[0023] [Figure 1] This shows a cross-sectional perspective view of a valve assembly having the valve component of the present invention. [Figure 2] Figure 1 shows an exploded perspective view of the valve assembly components. [Figure 3] Figures 1 and 2 show a side view of a partial cross-section of the valve assembly. [Figure 4] Figures 1-3 show perspective views of the triple helix core corresponding to the triple helix groove provided around the conduit in the deformable body of the present invention. [Figure 5] Figure 5A shows an example of a modification of the triple helix according to the present invention. Figure 5B shows an example of a modification of the double helix according to the present invention. Figure 5C shows an example of a modification of the single helix according to the present invention. [Figure 6] Shows a schematic view of the forces acting when inserting one or more medical instruments into the valve component of the present invention. [Figure 7] Shows a modification example of a valve assembly having a valve component according to another embodiment of the present invention. [Figure 8] Shows a modification example of a tapered valve body according to another embodiment of the present invention.

Mode for Carrying Out the Invention

[0024] The present invention relates to a valve for use in medical applications, and more particularly to a hemostatic valve used in intravascular procedures.

[0025] In this regard, and as shown in FIGS. 1 to 3, the present invention relates to a first deformable body 1 held within a housing 2, which further preferably houses a second deformable body 3. The first and second deformable bodies can be sized larger than the housing, such that they are in a compressed state when inserted into the housing. In this regard, the housing has a cylindrical body section for holding the first and second deformable bodies, and the diameters of these deformable bodies are 1 to 15% larger than the diameter of the cylindrical body section. These deformable bodies are formed of liquid-molded silicone, although any other suitable flexible material, such as rubber, can be used.

[0026] Threadedly engage an end cap 4 to the open end of the housing 2 to close the assembly 10 formed by the housing, the deformable body, and the end cap.

[0027] The end cap 4 has an aperture 5 through which one or more medical instruments, such as a catheter (not shown), can access the interior of the housing. The opposite end of the housing has a similar opening 6 through which one or more medical instruments can penetrate the assembly, for example, to enter an introducer sheath provided at this end of the housing.

[0028] As shown in Figure 3, each of the two deformable bodies 1 and 3 has preformed conduits 7 and 8, which are aligned along an axis passing through the openings 5 ​​and 6. The conduits 7 and 8 have a cross-section that is slightly smaller than the cross-section of the medical instrument used in the assembly, so that when one or more medical instruments are pressed into the assembly, the deformable body seals around one or more medical instruments. A typical needle valve can have a diameter of 1.2 mm, and the conduit diameter is slightly smaller than this. Of course, the dimensions of the valve components can be varied to suit the requirements of the instrument used.

[0029] The first deformable body 1 has one or more helical grooves 9 formed on the conduit surface, which define a helical contact surface 16 that engages longitudinally along one or more medical instruments through which the assembly is inserted. One or more helical grooves are preformed in the material of the first deformable body. One or more helical grooves may have a helical vane diameter in the range of 2 to 10 mm.

[0030] In some preferred embodiments, one or more helical grooves extend to a diameter of up to 6 mm or more preferably 5.6 mm around the central axis of a conduit penetrating the deformable body. One or more helical grooves further extend longitudinally along a large portion of the first deformable body.

[0031] As shown in Figure 6, the resulting inclination from the helical shape of one or more grooves 9 means that when one or more medical instruments are inserted, longitudinal compression is applied to the first deformable body 1, closing the helical cavities and gaps, and thus sealing the flow path through the valve assembly.

[0032] In this regard, the pitch of the helical grooves is preferably in the range of 2 to 10 mm, and more preferably 3 mm.

[0033] In some preferred embodiments, the diameter of the helical vane is in the range of 2 to 10 mm, and more preferably 5.6 mm.

[0034] In a preferred embodiment, three helical grooves are provided, as shown in Figures 4 and 5A. Each of these grooves preferably has a helical vane diameter in the range of 2 to 10 mm, more preferably 5.6 mm, and a pitch in the range of 2 to 10 mm, more preferably 3 mm.

[0035] In this regard, Figures 5A, 5B, and 5C show examples of triple, double, and single spiral modifications.

[0036] One or more helical grooves may have a width of 0.8 mm to 2.0 mm.

[0037] One size of valve assembly is intended to allow for sealing from wire insertion to a 23Fr OD Anaconda (RTM) delivery sheath.

[0038] While the valve assemblies described above incorporate passive valve components, in some situations, for example, a surgeon may need to refine the sealing characteristics of the assembly to control backflow leakage. Figure 7 shows a modified example of a valve assembly having a valve component according to another embodiment of the present invention, in which the deformable body 1 has a purse-string suture sealing configuration that allows for refinement of the sealing characteristics of the assembly.

[0039] Figure 8 shows another example of a modified valve assembly, in which the wall 11 facing the inside of the housing is tapered, similar to the outer surface wall of the first deformable body 1. In this way, by moving the first deformable body relative to the wall 11, the compressive strength of the deformable body 1 can be increased or decreased, thereby changing the sealing characteristics of the assembly.

[0040] In a preferred embodiment, the improved sealing characteristics obtained by the valve assembly allow for the simultaneous insertion of multiple catheters. [Explanation of Symbols]

[0041] 1. First transformable body 2 Housing 3. Second transformable body 4 End caps 5 hole 6 aperture 7 Conduit 8 Conduit 9 spiral groove 10 assembly 11 Walls 16 Spiral contact surface

Claims

1. In a valve component for a medical valve assembly, the valve component is: A first deformable body for positioning within a valve assembly housing, the first deformable body having a first conduit having a first end and a second end for housing one or more medical instruments inside, A second deformable body for positioning within a valve assembly housing, the second deformable body having a linearly extending second conduit having a first end and a second end for housing one or more medical instruments, the first conduit being aligned with the second conduit, and the first deformable body and the second deformable body being located within the same valve assembly housing, A plurality of helical grooves formed on the surface of the first conduit, wherein the plurality of helical grooves extend longitudinally from the first end to the second end of the first conduit, and the first helical groove is separated from adjacent helical grooves, and when the first deformable body is in an uncompressed state, the plurality of helical grooves extend from the surface of the first conduit into the first deformable body. A valve component equipped with the following features.

2. A valve component according to claim 1, wherein the first conduit extends from the base end of the first deformable body to the terminal end of the first deformable body, and one or more of the plurality of helical grooves extend from the surface of the first conduit into the first deformable body to define one or more helical contact surfaces for contacting one or more medical devices placed in the first conduit.

3. A valve component according to claim 1 or 2, wherein a plurality of helical grooves are defined on the surface of the first conduit.

4. A valve component according to any one of claims 1 to 3, wherein three helical grooves are defined on the surface of the first conduit.

5. A valve component according to any one of claims 1 to 4, wherein the first deformable body has a Shore A hardness of 5 to 20.

6. A valve component according to any one of claims 1 to 5, wherein the valve component is used for a hemostatic valve.

7. A valve component according to any one of claims 1 to 6, wherein the pitch of one or more of the plurality of helical grooves is in the range of 2 to 10 mm.

8. A valve component according to any one of claims 1 to 7, wherein the diameter of the helical vanes of one or more helical grooves in the plurality of helical grooves is in the range of 2 to 10 mm.

9. A valve assembly comprising a valve component according to any one of claims 1 to 8, further comprising a valve assembly housing, wherein the housing can be pressed into a compressed state by the first deformable body and the second deformable body.

10. A valve assembly according to claim 9, wherein the first deformable body and the second deformable body have an outer dimension that is 1 to 15% larger than the housing.

11. A valve assembly according to claim 9 or 10, wherein the first deformable body, the second deformable body, and the housing are each cylindrical, and the outer diameters of the first deformable body and the second deformable body are 1 to 15% larger than the inner diameter of the housing.

12. A valve assembly comprising the valve component according to claim 1, wherein the second conduit of the second deformable body has an expanding opening at the introduction end to facilitate the introduction of one or more medical devices.

13. A valve assembly according to claim 12, wherein the second conduit of the second deformable body has a tapered opening at the inlet end to facilitate the introduction of one or more medical devices.

14. A valve assembly according to claim 12 or 13, wherein the first deformable body and the second deformable body abut each other within the housing such that the first conduit and the second conduit are aligned.

15. A valve assembly according to any one of claims 9 to 14, wherein the walls of the valve assembly housing and / or the first deformable body are tapered, and the first deformable body can be variablely compressed when the first deformable body moves within the housing.

16. A valve assembly according to any one of claims 9 to 15, further comprising a drawstring suture for opening and closing the valve.

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