CN1822878A - Closure with channel slit for hemostasis valve assembly - Google Patents

Abstract

A closure for a valve (128) of a hemostasis valve assembly connector (100) includes a resilient closure member (130), the closure member (130) defining first and second opposed end surfaces (156; 160) and at least one passage slit (164). The passage slit is normally closed and extends between two end surfaces, the passage slit is arranged or opened through it by a tubular member (134), the passage slit (164) has a wider extent at the first surface than at the second surface. A plurality of such passage slits (164) may define a first common point of contact (166) on the first surface (156) and may extend radially outward from the point of contact (166) at the first surface (156).

Description

Closure with channel slit for hemostasis valve assembly

technical field

The present invention generally relates to the field of connectors for hemostatic valve assemblies, as used, for example, in angioplasty. An elongated member, such as a balloon catheter or a vascular stent, can be inserted into a living being's vasculature through a connector that includes a hemostatic valve for safe hemostasis. In particular, the present invention provides an improved closure member for a hemostatic valve assembly. More particularly, the present invention relates to a closure made of a resilient material and including a slit extending between two opposing surfaces.

Background of the invention

During endovascular procedures, such as during angioplasty, access to the vascular system of a living being, such as a heart patient, is required, for example for the insertion of balloon catheters or stent systems. Typically, access is provided through a connector that provides, for example, a connection to a guide catheter, the connector engaging a hemostatic valve to enable insertion of an elongated instrument into a living organism while providing safe hemostasis . A side arm may be provided as part of this connector to provide a connection to a branch tube for pressure monitoring, contrast injection and/or saline flushing. Connectors with side arms are often referred to as 'Y-connectors'. The hemostatic valve ensures that blood does not flow out of the connector while at the same time allowing a catheter, stent system or arteriotomy device to pass through the connector. At the distal end of the connector, a rotatable Luer may be provided for securing the connector to a corresponding member at the proximal end of the guide catheter.

U.S. Patent No. 5,195,980 (David G. Catlin) discloses a hemostatic valve included in a Y-connector. The hemostatic valve is included in the proximal end of the connector main section which includes a rotatable Luer at its distal end. A side arm engages the main section between the distal end and the hemostasis valve. Also disclosed is a resilient valve element comprising a normally closed slit arranged to extend through an inlet tube extending therethrough. Another example of a hemostatic valve is known from U.S. Patent No. 5.176,652 (Perry K. Littrell). The hemostatic valve of the aforementioned U.S. Patent '652 includes two elastic washers with slits that The slit allows the elongated member to pass through, while the slit completely passes through the corresponding gasket, and the gaskets are displaced obliquely relative to each other. US Patent '652 and US Patent No. 4,798,594 (Richard A. Hillstead) also disclose helically extending slits.

Coronary angioplasty techniques are generally described in: Bernhard Meier, Coronary Angioplasty, published by Grune & Stratton, Inc., published by Harcourt BraceJovanovich, 1987.

Summary of the invention

It is an object of the present invention to provide an effective seal between a passage in a connector and the outside atmosphere, especially at the proximal end of the connector, while at the same time allowing easy insertion of a catheter or conduit through a closure. bracket system. The closure of the present invention is made of a resilient material and includes a slit extending between two opposing surfaces. The slit is shaped to provide a closure with a positive seal when a conduit or stent system penetrates the closure and also to provide a seal when the valve is in the closed position, i.e. when no conduit or stent system penetrates the closure. A reliable closure.

Accordingly, the present invention provides a closure for a valve of a hemostatic valve assembly connector, said closure comprising a closure member made of a resilient material and defining a first and a second end surface, and at least one passage slit, said second end surface being opposite to the first end surface, said passage slit being generally closed and extending between the two end surfaces, the passage slit arranged To be opened through it by a tubular member, the passage slit has a length at the first surface greater than the length at the second surface, i.e. the passage slit has a wider extent at the first surface than at the second surface . In other words, the transverse length of the slit at one surface of the closure member is shorter than the transverse length of the slit at the other surface of the closure member. Thus, the slot defines a guide for the catheter or stent system which at least partially forces insertion of the member through the closure into oblique alignment with the closure as this system is moved through the closure. In a preferred embodiment, the closure is a gasket-like member made of a resilient or elastic material, such as silicone rubber or latex. The passage slit is preferably formed such that it defines a first axis of symmetry on the first surface which is aligned with a second axis of symmetry on the second surface so that the catheter or stent system passes through the closure When fitting, remain substantially perpendicular to the end surface of the closure. By providing a slit as described above, the risk of improper alignment of the catheter or stent system with the closure is reduced, and thus the catheter or stent system stretches/deforms the closure to such an extent in the area of the slit that There is a risk of creating a gap between the outer wall of the catheter or stent system and the closure.

In some preferred embodiments of the invention there is provided a plurality of access slots defining a first common contact point or intersection on the first surface and extending from the contact point at the first surface to Extend upwards and outwards. For example, three slits extending radially from the contact point may be provided or four slits may be provided and the four slits are arranged to form a cross. On the opposite second surface, the slits preferably define a second common contact point, each slit preferably being substantially shorter at the second surface than at the first surface. Preferably, the length of each slit at the second surface is at most 1/10, more preferably at most 1/20, the length of that slit at the first surface. In a desirable embodiment, the slits extend a length close to zero at the second surface so that they meet in a point on the second surface, said point being preferably arranged in the center of the surface.

To facilitate insertion of a catheter or stent system through the closure, one of the first and second end surfaces, such as preferably at least a portion of the second end surface, may have a concave shape.

For mounting in the connector, the second end surface is preferably oriented facing the proximal end of the connector.

Another object of the present invention is to provide an effective seal between a channel of the connector and the outside atmosphere, especially a seal at the proximal end of the connector, while at the same time allowing easy insertion of a catheter or stent through the closure system. Thus, a flat surface of the closure member may abut a proximal surface of a main section of the connector. It is desirable to provide a closure that includes a reliable seal at the periphery of the connector main section. The connector may include a longitudinally extending main section having a longitudinally extending valved through passage at the proximal end of the connector. The closure may comprise a closure member with a plane abutting a proximal end surface of the main section, one of the plane and the end surface having a protrusion for engaging a surface located on the plane/end. A corresponding dimple in the other of the surfaces. It should be appreciated that the protrusions and dimples provide an alternative seal to that provided by conventional flat gaskets. In a preferred embodiment, the closure member is made of a resilient material suitable for the protrusion/recess when the plane of the resilient closure and the end surface of the main section are offset relative to each other. deformation in the pit area. Thus, a liquid-tight seal is provided in the outer periphery of the channel at its proximal end, preferably the protrusions and dimples continue an angle of 360°, so sealing is effective along the entire end surface of the main section . The protrusions and indentations preferably extend along eg a peripheral portion of the closure member. The protrusion may be formed as an integral part of the closure member, which may extend along a peripheral portion of that surface facing the connector end surface. Preferably, the protrusion extends in the longitudinal direction, ie across the plane of its end surface. The protrusion may be tapered so that it is wider at its proximal end than at its distal end. The closure member may define a core segment that fits into the longitudinal channel within the connector. The core segment may be tapered so that its diameter is larger at its proximal end than at its distal end.

As mentioned above, the closure may be included in a connector comprising a longitudinally extending main section with a valve at its proximal end, said valve having an open state and a closed state, in the above When open, an elongated member can be inserted into the channel. Before inserting a device, such as a catheter or a drug-coated stent, through the connector and into the vascular system of an organism, the operator, such as a doctor, should ensure that the valve is properly opened, because otherwise the outer surface of the catheter or stent will be damaged. Risk of scratching valve components with consequent damage to the surface of the device or loss of a precise dose of drug placed on a drug-coated stent. However, given the influence of external circumstances such as especially psychological stress, the operator sometimes cannot be sure that the valve is open before attempting to insert an instrument through the valve. After attempting to insert the device through a closed valve, the operator may not always be aware that the drug has scratched off the holder or that actual damage has been done to the surface of the device, and he may, after opening the valve properly, now for example insert the A damaged device or what appears to be the wrong dose of drug is added to the patient's blood vessel. This approach can seriously jeopardize the patient's health and often results in the need for additional treatment and prolonging the patient's hospital stay. Accordingly, it would be desirable to provide a mechanism for reducing the risk of damage to an instrument to be inserted into the vascular system through the valve of the connector. Like this, valve is preferably arranged at the proximal end place of connector, and described valve can have an open state and a closed state, can insert an elongate member in the channel when above-mentioned open state, and above-mentioned valve comprises a Indicator to indicate the status of the valve. The indicator can provide an optical and/or tactile feedback to the operator so that the operator can easily determine the status of the valve by looking at it or by touching it.

In a preferred embodiment, the valve includes a valve opener which is movable longitudinally along the outer surface of the main section of the connector so that the state of the valve can be determined by making the valve opener relative to the main section Move to change. A valve opener, or in the case of other embodiments, other movable mechanism may advantageously be arranged in the vicinity of the indicator, which may include an optical mechanism for providing at least a portion of the connection in the open state. The optical appearance of the connector is different from the optical appearance of that part of the connector in the closed state. For example, the valve may comprise an elastic closure member, such as a silicon rubber member, arranged to seal the proximal end of the connector in the closed state of the valve, and the valve opener may comprise a piercing member, said piercing member being in contact with the above-mentioned The channel extends coaxially and is at least partially internal to said channel. The piercing member may be arranged relative to the elastic closure member such that it passes through the closure member in the open state of the valve. This embodiment of the valve is well suited to an embodiment of a valve opener comprising a transparent portion and an opaque portion, and wherein the main segment of the connector comprises a colored segment at its proximal end, when The colored segment is covered by the opaque portion of the valve opener when the valve is open and visible through the transparent portion when the valve is closed. In this way, when the valve is in the closed state, the colored segment can be clearly seen by the operator, but when the valve is in the open state, the colored segment is completely hidden. Thus, a superficial and quick glance at the valve allows the operator to determine the status of the valve. Preferably, the proximal surface of the valve opener is opaque, so the operator is not in danger of seeing the colored segments through the proximal surface in that state, in which case the colored segments are concealed.

Although not preferred, a so-called 'Touhy Boust' valve may be provided as the hemostasis valve, the 'Touhy Boust' valve being known per se and comprising an elastic membrane having an opening through which the catheter extends, and Close by twisting a cap around the perimeter of the catheter. However, a disadvantage of the 'Touhy Borst' design from the standpoint of ease of use is that it requires a separate introducer needle or tubing to pass through the valve to open the membrane so that a catheter or stent can be inserted without damage. Thus, so-called piercing valves have become increasingly difficult because the insertion and co-use of vascular stents (including balloon-expandable stents and self-expanding stents) leads to attention to the frictional effect of the device through the valve and the need to maintain the position of the stent on the balloon. more popular. Examples of such piercing valves are those described herein in some preferred embodiments of the invention, the valves disclosed in US Patent No. 5,195,980 and the valves described in US Patent No. 5,176,652.

Embodiments of connectors comprising a side arm for connecting the connector to a branch pipe, so-called 'Y-connector' embodiments, may be included in a kit according to the invention. The tool also includes a side arm tube for the side arm and may include a plunger.

Certain embodiments of the connectors of the present invention may have a main section fabricated from two separate coextensive parts that are interconnected or joined to each other, the two separate coextensive parts being Each part is preferably made of a plastic material. When interconnected, the two parts should be able to withstand a certain pressure, such as injection pressure, in a longitudinal channel extending inside the two parts and defined by the inner surfaces of the two parts. It has been found that between separate components such as connectors, it is sometimes difficult to make adhesively bonded interconnections because the manufacturing process cannot be controlled so precisely that the finished connector must withstand certain stresses. Accordingly, it would be desirable to provide a connector for a hemostatic valve assembly that does not rely on glue as the sole or primary means of interconnecting two components, while at the same time ensuring a relatively uncomplicated and inexpensive manufacturing process.

The longitudinally extending main section of the connector can be manufactured from a proximal part and a distal part. The distal and proximal components of the main section may each define a longitudinally extending through passage. The connector may also include a connection mechanism for providing a connection between the proximal part and the distal part, so that when interconnected, the distal part and the proximal part are coextensive in the longitudinal direction, the connection mechanism comprising a protruding portion , said projecting portion being integral with one of said parts and adapted to engage a recessed part of the other of said parts, thereby securing the two parts to each other in the longitudinal direction. Thus, due to the essentially mechanical connection between the proximal and distal components, the connector can be used to withstand a specified internal pressure which can be determined according to the specifications of the materials from which the two components are made and the individual components. Dimensions are precisely calculated. In addition to the mechanical means provided at the interconnection, the interconnection may be reinforced with glue, but in a preferred embodiment of the invention, the connectors are not assembled with glue. Preferably, the interconnection is formed as a snap-lock connection, such as a self-fixing snap-lock. In a preferred embodiment of the invention, the protruding portion is a barbed portion. The barbed portion may, for example, be provided as part of the outer periphery of the first of the two parts, dimensioned to at least partially surround the end of the second of the two parts. The surrounding part may thus be provided, eg at the transition between its small and larger diameter sections, with a flange or a collar into which the barbed part may engage. The barbed portion preferably comprises a plurality of barbs arranged along the periphery of the first member. In order to enable the barbed portion of the first part to slide over the second part, the barbed portion may be flexible in the radial direction, but preferably has no or at least less flexibility in the longitudinal direction . This radial flexibility can be produced by longitudinally extending slits which are provided in the ends of the first part. In one embodiment of the invention, one end of the distal member is adapted to receive one end of the proximal member, the barbed portion is provided at the proximal end of the distal member, the recessed portion includes a set A loop portion, such as a sharp-edged loop portion, on the outer surface of the proximal member. In other embodiments, the barbed portion may be provided at the end of the proximal member which may receive one end of the distal member.

To prevent blood and/or other fluids from flowing out of the connector at the interconnect, a sealing mechanism may be provided at the interconnect. Such a sealing mechanism may comprise a resilient member, such as an O-ring, clamped, for example, between the proximal and distal components when the proximal and distal components are interconnected so that it surrounds the The outer collar portion of the inner one of the two parts fits and tightly closes said outer collar portion, and it fits inside the inner collar portion of the outer one of the two parts and tightly closes said inner collar portion.

The interconnection can be such that the distal and proximal parts can be rotated relative to each other about an axis extending in the longitudinal direction, for example, if one or both of the two parts has a threaded portion for engaging a corresponding member Such rotation is desirable as is the thread of the guide catheter. In a preferred embodiment of the invention, the distal part constitutes a rotatable Luer, so there is no need to manufacture the Luer as a separate part. The first threaded or grooved portion may be provided on an outer, possibly tapered wall of the distal member, and the second threaded portion may be provided on the inner surface of the distal portion. In the latter case, when viewed in the radial direction, the threaded portion may be disposed between an annular wall of the distal part and a peripheral outer wall surrounding a longitudinally extending thread through the connector. aisle.

The connector may be a Y-connector having a side arm to provide connection to a branch for pressure monitoring, contrast injection and/or saline irrigation. The side arm may be arranged to receive a conduit interconnecting the side arm with a piston, such as a standard three-way piston. The distal part and the proximal part of the connector can be manufactured by injection molding one plastic material.

In general, some embodiments of the connectors of the present invention can be used to assemble a variety of stents including, but not limited to, Strecker stents, Palmaz stents, Wallstents, self-expanding Nitinol stents such as Bard Luminex stents, Symphohy stents, Smart stents, and AVE SE mounts, Perflex mounts, AVE mounts, Intrastents, Instents, Herculink, and Dynalink. Likewise, the connector of the present invention can be used to fit a variety of catheters including, but not limited to, Mainz balloon catheters, Monorail balloon catheters, PCTA (percutaneous coronary angioplasty) catheters, and ultrasound catheters.

Brief introduction to the drawings

The above aspects of the invention will now be further described with reference to the accompanying drawings, in which:

Figure 1 shows a longitudinal sectional view of a connector according to the present invention,

Figure 2 shows an exploded side view of the connector of Figure 1 and an associated piston,

Figure 3 shows a longitudinal sectional view of a valve included in the connector of Figures 1 and 2, the valve being in a closed state,

Fig. 4 shows that the valve of Fig. 3 is in an open state,

Figure 5 shows the main section of the connector having a dimple in its end surface for providing a seal extending circumferentially at the proximal end of the connector,

Figure 6 shows an end view of a closure member for installation at the proximal end of the connector of Figure 5,

Figure 7 shows a cross-sectional view of an embodiment of the closure member of Figure 6,

Figure 8 shows a sectional view of an alternative embodiment of the closure member of Figure 6,

Figure 9 shows a sectional view of the valve of Figures 3 and 4, including an indicator for indicating the state of the valve,

Figure 10 shows a longitudinal sectional view of a colored member included in the valve indicator of Figure 9,

Fig. 11 shows a side view of a second embodiment of the connector according to the present invention,

Fig. 12 shows a side view of a third embodiment of the connector according to the present invention,

Figure 13 shows the valve opener in the embodiment of Figures 11 and 12,

Figure 14 shows a longitudinal sectional view of the interconnection between the proximal part and the distal part of the connector of Figures 1, 2, 11 and 12,

Figure 15 shows a longitudinal sectional view of the distal part of Figure 14,

FIG. 16 shows a perspective view of the proximal component of FIG. 15 .

Detailed description of the drawings

As will be understood from the following description of preferred embodiments of the invention, all of the above aspects of the invention are included in one embodiment.

As shown in Figures 1 and 2, a Y-shaped connector 100 includes a proximal part 102 and a distal part 104, the proximal part 102 and the distal part 104 are coextensive in the longitudinal direction and connected end to end Assembled in the same manner, while placing the distal end 106 of the proximal member 102 into the proximal end 108 of the distal member 104. The distal member 104 is formed as a rotary swivel lock having a first outer grooved or threaded portion 109 and a second inner threaded portion 111 . Within each of the proximal and distal members, a longitudinally extending through channel 110 and 112, respectively, is provided. When assembled, the proximal and distal components together define a main section 114 . At the interconnection between the proximal part and the distal part, the distal part defines a protruding portion 116, preferably a barbed portion, which protrudes radially inwardly and engages the A recessed portion 118 of the proximal member 102, said recessed portion taking the shape of a loop defined by a transition in the outer diameter of the proximal member. The interconnections will be further described below with reference to Figures 7-9. Projection 116 is shaped to provide a spring lock of distal member 104 to proximal member 102 . When assembled, the proximal and distal components will clamp between them an O-ring disposed at a reduced diameter segment of the proximal component, and a The corresponding diameter widens at the segment. Side arms 122 are provided for connecting the connector 100 to a branch line (not shown) for pressure monitoring, contrast injection and/or saline flushing. As shown in FIG. 2 , the connection from the side arm 122 to the branch tube may be provided by a piston 124 and a side arm tube 126 .

The connector 100 of Fig. 1 includes at its proximal end: a valve 128 comprising an elastic closure member 130; a valve opener 132; and a piercing member 134 processed into a certain shape, so as to provide an elongated passage opening, the said elongated passage opening is in the closed state of the valve as shown in Figure 3, so that the closing member can seal the proximal end of the passage 110, and in the open state of the valve, as As shown in Figure 4, the piercing member passes through the elastic closure member 130 to allow a catheter or a stent (not shown) to pass through the valve. Piercing member 134, as shown in FIGS. 3 and 4, is integral with valve opener 132, which is displaceable longitudinally along the outer surface of proximal member 102, as indicated by arrow 138 in FIG. So that when the valve opener is at the closest position, the valve is in a closed state, as shown in Figure 3, and when the valve opener is at the farthest position, the valve is in an open state, as shown in Figure 4. The indicator for indicating the status of the valve includes a colored member 136, see FIG. 2 .

Some embodiments of the present invention will now be further described with reference to FIGS. 5-8. Wherever elements are referred to in this specification, the same reference numerals are used to the extent that the same parts are referred to. However, it should be understood that although the same reference numerals are used, structural differences may exist.

The main section 114 shown in FIG. 5 has a proximal surface 152 . The proximal surface 152 defines a depression in the form of a groove 154 . The slot is intended to fit into an annular projection 158 provided on the closure member 130, see FIGS. 6-8. When closure member 130 is biased toward surface 152 of main section 114 , protrusion 158 deforms within groove 154 to provide a positive seal along end surface 152 . The closure member 130 has three slits, which are referenced 162 in the embodiment of FIG. 7 and referenced 164 in the embodiment of FIG. 8 . The slots 162 , 164 extend radially outward from a first common contact point provided at the first surface 156 of the closure member 130 . In the embodiment of FIG. 7 , the slits 162 have a length at the first surface 156 that is substantially equal to their length at the second surface 160 of the closure member. However, in the embodiment of FIG. 8 , the slits 164 have a length at the second surface 160 that is close to zero, ie three slits 164 meet at one second contact point 168 . In both embodiments, a concave portion 170 is provided to facilitate insertion of a catheter or stent system through the closure member.

Figure 9 shows a cross-sectional view of the valve of Figures 3 and 4, including an indicator for indicating valve status. The indicator comprises a colored member 136, which may for example be yellow or any other highly saturated colour. The proximal segment 140 of the valve opener 132 is opaque, while the distal portion 142 of the valve opener is transparent. Thus, the colored member 136 is visible through the transparent portion when the valve is in the closed state as shown in FIG. 9 . However, when the valve is in the open state, that is, when the valve opener 132 is moved to the position shown in FIG. Can't see it. For example, if the colored member 136 has a highly saturated yellow, it will be immediately visible to the operator when the valve is in its closed state, thus making it clear not to attempt to insert a catheter or a stent system through the valve. , and when the valve is in its open position, there will be no yellow visible, thus clearly indicating that the catheter or stent system can safely pass through the valve. It should be understood that the valve can alternatively be designed such that the colored member is visible when the valve is in its open position, but not when it is in the closed position.

The colored member 136 is shown in detail in FIG. 10, from which it can be seen that a protruding portion, such as preferably a barbed portion 144, can connect the colored member to the The proximal part 102 of the connector exhibits a radial elasticity and substantially no longitudinal elasticity because of the barbed portion. Radial resilience may be provided by several longitudinally extending slits in member 136 made substantially the same as those provided in the region of the barbed portion of connector distal part 104, see FIG. 16 . As shown in FIG. 9, the proximal part 102 defines a recessed portion in the form of a collar 146 so that when the colored member 136 and the proximal part 102 are interconnected, the barbed portion is securely secured relative to the proximal part 102. Colored member 136 .

Figures 11-13 illustrate an alternative embodiment of the valve opener 133, and like elements shown above in Figures 1-10 are designated with like reference numerals. However, it should be understood that structural differences may exist although the same reference numerals are used in practice. The connector 100 of FIGS. 11-13 includes an opaque valve opener 133 having a transparent or cut-away segment 135 . A colored member (not shown) is provided similar or identical to colored member 136 in FIGS. 2, 9 and 10 described above. When the valve opener is in its distal position, ie when the valve is open, the colored member is visible through the transparent or cut-out section 135 . In the closed state of the valve, ie when the valve opener 133 is in its proximal position, the colored member is not visible. Preferably, the proximal surface 137 is opaque, so the colored member cannot be seen through the end surface. In some alternative embodiments, segment 135 is also opaque, while the middle segment 139 of valve 133 may be transparent so that the colored member is visible in both the open and closed states of the valve. In yet another alternative embodiment, segment 135 may be transparent or cut, and intermediate segment 139 is also transparent. Figure 12 shows a connector 101 without side arms.

The interconnection between the distal and proximal parts 102 and 104, respectively, is based on the same principles as the interconnection between the colored member 136 and the proximal part 102 as described above with reference to FIGS. 9 and 10 . Accordingly, as shown in FIGS. 14 and 15 , the proximal member 104 has a barbed portion 116 that engages the loop 118 of the proximal portion 102 . An annular space 150 accommodates O-rings, which are not shown in FIGS. 15 and 16 but are indicated by reference numeral 120 in FIG. 1 . The distal member 104 is shown separately in FIGS. 15 and 16. It is also apparent from FIGS. The distal part 104 is arranged peripherally and has slits 148 therebetween which provide a radial flexibility which enables the second part 104 with the barbed portion 116 to be snap-locked. The loop 118 of the proximal component 102 is engaged in a non-stop manner.

The operation of the connector 100 described above with reference to the accompanying drawings is as follows:

1. Attach a branch tube (not shown) to the side arm 122 of the connector.

2. Connect the distal end of the connector to the proximal end of the guide catheter (not shown).

3. Rinse the connector with salt water to remove air bubbles. Valve flushing is performed when the valve is in the open position.

4. Attach a pressure/input device (not shown) to the manifold. To avoid air inhalation, make sure all connections are tight.

5. Insert the guide catheter while following the guide catheter insertion procedure generally recommended by the guide catheter manufacturer.

6. Insert a guide wire (not shown) or a guide wire and a dilation catheter (not shown) into the connector. When inserting only the guide wire, a metallic guide wire insertion tool (not shown) should be used in order to protect the tip of the guide wire. A PTCT dilation catheter can be inserted alone without opening the valve. However, for any device larger than the dilation catheter, such as stents, ultrasound catheters, etc., the valve should be opened with the valve opener 132 .

7. Then follow whatever procedures are prescribed by the catheter or stent manufacturer.

The dimensions and other specifications of a preferred embodiment of the connector 100 are as follows:

The inner diameter of the narrowest part: 2.4mm-9.0mm.

The maximum diameter of the instrument to be inserted: 2.33mm-8.0mm.

The minimum diameter of the instrument to be inserted: 0.17mm-1.10mm.

Maximum pressure resistance for PTCA catheters and guidewires: 8 Atm or 1 atm in case of percutaneous grafts.

Maximum pressure resistance without equipment: 21Atm-2atm.

Metal Insertion Tool Length: 10cm-2cm.

Metal insertion tool inner diameter: 0.64mm-2.00mm.

The first value of the above interval relates to PTCA, while the second value of the interval relates to AAA grafting (percutaneous abdominal aortic stent grafting).

Claims (15)

1. closure member, a valve (128) that is used for a kind of haemostatic valve assembly adapter (100), above-mentioned closure member comprises a closure member (130), and described closure member (130) is made with a kind of resilient material, and limit one first with one second relative end surfaces (156; 160) and at least one passage slit (164), described passage slit (164) is closed usually, and between above-mentioned two end surfaces, extend, passage slit is arranged to and runs through it by a tubular element (134) and open, simultaneously passage slit (164) have one at the first surface place than in the big scope in second surface place.

2. according to the described closure member of claim 1, comprise a plurality of passage slit (164), described a plurality of passage slit (164) goes up at first surface (156) and limits one first shared contact point (166), and upwards stretches out from contact point (166) footpath of first surface (156).

3. according to the described closure member of claim 2, it is characterized in that a plurality of passage slit (164) go up at second surface (160) and limit one second shared contact point (168).

4. according to one of them described closure member of claim 1-3, it is characterized in that at least one passage slit (164) has a length on second surface (160), described length is that passage is gone up 1/10 of length at first surface (156) at the most.

5. according to one of them described closure member of claim 1-4, it is characterized in that at least a portion first end surfaces (156) and at least a portion second end surfaces (166) limit two substantially parallel planes; And the axis that extends between the first and second shared contact points is vertical with above-mentioned two planes basically.

6. according to one of them described closure member of claim 1-5, it is characterized in that first and second end surfaces (156; 160) at least a portion of one of them (170) is a concave surface.

7. according to the described closure member of claim 6, it is characterized in that above-mentioned concave part (170) is arranged on the second surface (160).

8. require one of them described closure member according to aforesaid right, it is characterized in that, the proximal end surface (152) of a plane (156) the butt connector master segmentation (114) of closure member (130), above-mentioned plane and end surfaces (152; 156) one of them has a projection (158), and described projection (158) is used for joint and is arranged on above-mentioned plane and end surfaces (152; 156) another interior respective dimple (154) among.

9. according to the described closure member of claim 10, it is characterized in that closure member (130) is made by a kind of resilient material, above-mentioned resilient material is suitable for when above-mentioned plane and end surfaces (152; When 156) offseting relative to each other, in the zone of above-mentioned projection or pit, be out of shape.

10. according to claim 8 or 9 described closure members, it is characterized in that projection (158) becomes integral body with closure member (130).

11. an adapter (100), described adapter (100) is used for a haemostatic valve assembly, and comprises one according to one of them described closure member of claim 1-10.

12., it is characterized in that the valve (128) that has closure member is arranged near the near-end of adapter according to the described adapter of claim 11.

13., it is characterized in that the second surface of closure member (160) is orientated the near-end in the face of adapter according to the described adapter of claim 12.

14. a tool set comprises a kind of according to one of them described adapter (100) of claim 11-13 and a side arm tube (126) that is used for adapter side arm (122).

15. according to the described tool set of claim 14, also comprise a piston (124), described piston (124) is connected on the end of above-mentioned side arm tube (126).

Images