JP2002505920A - Hemostatic valve assembly with guide wire seal - Google Patents

Abstract

SUMMARY [57] A hemostatic valve assembly (12) configured to be usable in a catheter introducer (10) is disclosed. The valve assembly (12) includes a first seal member (30), a second seal member (32), and a third seal member (34). The second seal member (32) includes a guide wire seal member. The guide wire sealing member has a plurality of lip members (74) forming a pair of slits (76) arranged orthogonally to each other, and an opening (84) intersecting at least one slit. ing. The opening (84) is configured to sealingly engage a small diameter guidewire (40) to prevent blood bleeding from the catheter introducer (10) through the valve assembly, and the slit (84). 76) allows the insertion of a long member having a large diameter, that is, a loader (24).

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

TECHNICAL FIELD OF THE INVENTION

The present invention relates generally to medical devices and, more particularly, to a hemostatic valve for use in a percutaneous catheter introducer.

[0002]

2. Description of the Related Art

The use of catheter introducers in percutaneous medical surgery is well known in the art. The catheter introducer typically includes an elongate sheath having a first end located within a patient's vein or artery and a second end located on the outer surface of the patient's epidermis. With the evident importance of controlling bleeding in the use of such catheters, conventional catheter introducers include a hemostatic valve assembly. A hemostatic valve assembly is positioned at the second end of the sheath so that a loader, catheter or other medical device can be introduced through the sheath and into the patient while preventing blood from flowing out of the introducer. Is done.

[0003] In many percutaneous medical procedures, a small diameter guidewire is inserted into a vein or artery through the introducer sheath. The guidewire serves as a guide for large diameter loaders, catheters, or other medical devices used in later stages of the procedure. Therefore, the valve assembly needs to provide a sufficient sealing function around the small diameter guidewire to prevent excessive blood loss through the introducer. However, the valve assembly may also allow a large diameter loader, catheter, or other medical device to pass therethrough and sealingly engage these large diameters to prevent blood bleed through the introducer. Must gain.

[0004] One type of valve commonly used to control blood outflow is
This is called a "crown-shaped" valve. The conventional flared valve includes a pair of walls each having a substantially flat plate shape, and these walls meet and intersect along a line or a slit. However, such a mouthpiece is not well-suited for use alone in a catheter introducer where a medical device is inserted through the valve. When inserting an instrument into a conventional mouthpiece, the instrument passes through a slit between the joining walls of the mouthpiece. This pulls the walls apart from each other, creating an undesirable outflow channel between the slit and the instrument.

[0005] US Patent No. 4,929,235 discloses a catheter introducer valve assembly that is configured to overcome the disadvantages of conventional mouthpiece valves.
The valve assembly includes a first valve having a Y-shaped slit. Y
The T-shaped slit is occluded to prevent any outflow of blood from the introducer sheath when the catheter tube is not present. A second valve, typically a disc-shaped seal member with a small through hole, is used to prevent blood spillage when and after the catheter tube is inserted into the introducer. Seal around the catheter tube.

[0006] Prior art catheter introducer valve assemblies have successfully accomplished the primary purpose of preventing blood outflow within the sheath when no medical device is present therein. Also, conventional valve assemblies are effective in penetrating the outer diameter of a catheter or other medical device and sealingly engaging the outer diameter.

However, conventional catheter introducer valve assemblies cannot adequately seal around both the small diameter guidewire and the large diameter medical device through which the introducer is inserted. That is, conventional valve assemblies typically include a seal member adapted to sealingly engage around a relatively large diameter medical device. Therefore, no seal is formed around the relatively small diameter guidewire. Also, in the aforementioned U.S. Pat. No. 4,929,235, the through-hole of the second valve is typically about 0.3 inches in diameter for a catheter or loader. And have a diameter such that they can engage in a sealing manner. A typical guidewire has a diameter of about 0.035 inch. Thus, if the catheter or loader is removed, leaving only the guidewire in the valve assembly, there will be a clear gap between the second valve and the guidewire, which will Escapes through the introducer.

[0008] Accordingly, the situation where no medical device is inserted through the catheter introducer valve assembly, the situation where a relatively large diameter medical device is inserted through the valve assembly, and the case where a relatively small diameter medical device is inserted through the valve assembly. There is a need for a catheter introducer valve assembly that can effectively seal blood outflow under three distinct and different situations. In addition, it can provide an effective seal against the outer surface of the guidewire when only the guidewire is inserted through the valve assembly, and can easily pass a relatively large catheter or loader. There is a demand for a guide wire sealing member.

[0009]

[Means for Solving the Problems]

The present invention provides a hemostatic valve assembly configured for use in a catheter introducer. In a first mode of operation, the valve assembly seals outflow of blood through the catheter introducer when no instrument or device is inserted through the catheter introducer. In a second mode of operation, the valve assembly seals the periphery of a relatively small diameter guidewire. In a third mode of operation, the valve assembly seals a relatively large diameter elongate member, ie, the periphery of the catheter. The valve assembly thoroughly and continuously seals the blood outflow in all three modes of operation.

[0010] A valve assembly according to the present invention includes a valve body including a first seal member and a second seal member. The valve body has a central passage having a longitudinal central axis, and inlet and outlet ends located on both sides. The entrance end is
It is configured so that a guide wire can be introduced and an elongate member can be introduced. The elongate member can be an introducer or a catheter. However, the elongate member is not limited to these and can be any conventional medical device used in a percutaneous catheter introducer.

[0011] The first sealing member, that is, the mouth-shaped sealing member, includes an elastic body having a cylindrical support wall and a plurality of lip members extending in a radial direction. The lip members are circumferentially separated from each other and define at least one normally closed slit extending transversely to the central passage to prevent fluid outflow from the housing through the valve assembly. are doing.

The second seal member, ie, the guide wire seal member, includes an elastic body having a cylindrical support wall and a plurality of lip members extending in a radial direction. The lip members are spaced apart from one another in a circumferential direction and form at least one slit extending transversely to the central passage and an opening coaxial with the longitudinal central axis. are doing. The opening is provided in the guidewire to prevent fluid flow out of the housing through the valve assembly when the guidewire is disposed in the second seal member and the elongate member is not present in the second seal member. It is configured to be able to engage with the seal in a sealing manner. At least 1 from the support wall to the opening
One load-forming rib extends and biases the load-forming rib in a direction to sealingly engage at least two of the plurality of lip members. A substantially hemispherical inner surface opens toward the inlet end for guiding the guidewire toward the opening.

[0013] The valve assembly preferably comprises a third sealing member, ie, a disk-shaped sealing member for the catheter. A third sealing member, a catheter disk-shaped sealing member, includes an elastic body having a cylindrical support wall and a disk extending radially inward from the support wall. The disc forms an opening coaxial with the longitudinal central axis. The opening may sealingly engage the elongate member to prevent fluid outflow from the housing through the valve assembly when the elongate member or catheter is positioned within the third seal member. It is configured as follows.

Accordingly, it is an object of the present invention to provide a hemostatic valve assembly that effectively seals outflow of blood through the valve assembly when the medical assembly is not inserted through the valve assembly.

Another object of the present invention is to provide a method for sealing blood outflow when the medical assembly is not inserted through the valve assembly and for easily sealing the periphery of medical devices of various sizes. It is to provide a valve assembly.

Still another object of the present invention is to provide a guide that can effectively seal the periphery of a relatively small-diameter guide wire and can easily insert a relatively large-diameter medical instrument. The object is to provide a sealing member for a wire.

Yet another object of the present invention is to provide a method for sealing a relatively large-diameter medical device that is capable of sealingly engaging a relatively large-diameter medical device while moving the device. It is also possible to provide a valve assembly that can also sealingly engage, thereby preventing blood flow through the valve assembly.

[0018]

BEST MODE FOR CARRYING OUT THE INVENTION

FIG. 1 is a cross-sectional view illustrating a catheter introducer including a valve assembly according to the present invention. FIG. 2 is a sectional view showing a valve assembly according to the present invention, showing a first operation mode. FIG. 3 is a cross-sectional view illustrating a valve assembly according to the present invention, showing a second operation mode when a guide wire is disposed inside. FIG. 4 is a cross-sectional view illustrating a valve assembly according to the present invention, illustrating a third mode of operation when a catheter is disposed therein. FIG. 5 is a plan view showing a flared seal member (first seal member) in the valve assembly according to the present invention. FIG. 6 is a perspective view showing a guide wire seal member (second seal member) according to the present invention. FIG. 7 is a plan view showing a guide wire sealing member according to the present invention. FIG. 8 is a sectional view showing the guide wire sealing member of the present invention along a section taken along line 8-8 in FIG. FIG. 9 is a bottom view showing a disc-shaped sealing member (third sealing member) for a catheter in the valve assembly according to the present invention. FIG. 10 is a plan view of the disc-shaped sealing member for a catheter shown in FIG. 9.

First, as shown in FIG. 1, the catheter introducer 10 is shown as including a hemostatic valve assembly 12, a sheath tube 14, and a housing 16. In the vicinity of the distal end 19 of the housing 16, an angular orientation part 18 is arranged. The angle orienting section 18 serves as a means for injecting some medium, such as a contrast medium or an imaging medium, into the catheter introducer 10. The sheath tube 14 extends outwardly (distally) from the distal end 19 of the housing and is configured to be introduced into a patient in a known manner. A lock cap 20 is received within the proximal end 22 of the housing 16. Lock cap 20 locks valve assembly 12 within catheter introducer 10 both radially and axially.

An elongated member, preferably a hollow loader or catheter 24, is introduced into the lock cap 20 and further through the valve assembly 12 and further through the sheath tube 14 to a final destination in the patient's blood vessel. And so that it can be arranged. Catheter 24 typically has a relatively large outer diameter or member diameter, on the order of 0.3 inch (7.62 mm). The valve assembly 12 forms a passageway for the outer periphery of the catheter 24 and sealingly engages the outer periphery of the catheter 24. Thereby, the catheter introducer 10
Blood loss from the patient through is minimized or prevented. About 0.08
A guidewire 26 having a relatively small outer diameter or wire diameter of about 0.035 inches (89 mm) is configured to be passed through catheter 24 within catheter 24 and into the patient's blood vessels. ing.

In conventional medical surgery, the catheter 24 is removed while leaving the guidewire 26 in place in the patient's blood vessels. The valve assembly 12 also sealingly engages the outer surface of the guidewire 26 at this point in the procedure. A catheter 24 for supporting a particular medical device (not shown), such as a balloon catheter, is then reinserted through the valve assembly 12 of the catheter introducer 10. The catheter 24 is inserted through the sheath tube 14 to a desired position in the blood vessel of the patient while being guided on the guide wire 26. Instead of the catheter 24 being reinserted through the valve assembly 12, an elongated member or medical device having an outer diameter intermediate between the outer diameter of the catheter 24 and the outer diameter of the guidewire 26 often replaces the catheter 24. Note that it is used for

The hemostatic valve assembly 12 includes a valve body 28 having a first seal member 30, a second seal member 32, and a third seal member 34. Valve body 28
Form a central passage 36. The central passage 36 has a longitudinal axis 38 and has an inlet end 40 and an outlet end 42 located on opposite sides in the longitudinal direction. The inlet end 40 faces the proximal end 22 of the housing 16 and is configured to receive the catheter 24 and the guidewire 26. The outlet end 42 is arranged near the front end 19 of the housing 16.

As shown in FIG. 2, the first seal member 30 includes the catheter 24 and the guide wire 2.
6 is configured to seal any outflow of blood through the catheter introducer 10 when a medical device, such as 6, is not disposed within the valve assembly 12. The second seal member 32 is configured to seal any outflow of blood through the catheter introducer 10 when only the guidewire 26 is positioned within the valve assembly 12 as shown in FIG. . Also, as shown in FIG. 4, the third seal member 34 is configured to be able to sealingly engage the outer peripheral edge of the catheter 24, thereby disposing the catheter 24 in the valve assembly 12. In such a case, it is possible to prevent any outflow of blood through the catheter introducer 10. In addition, the third seal member 34 is used for the guide wire 2.
It should be noted that the medical device having an outer diameter intermediate between the outer diameter of the catheter 6 and the outer diameter of the catheter 24 can be sealingly engaged with the outer peripheral edge of the medical device. Third
The seal member 34 is disposed between the first seal member 30 and the second seal member 32. Thereby, the second seal member 32 forms the inlet end 40 of the valve body 28, and the first seal member 30 forms the outlet end 42 of the valve body 28.

As shown in FIGS. 2 to 5, the first seal member 30, that is, the mouth-shaped seal member,
It has a body 44 axially aligned with the central axis 38. The body 44 is preferably formed from a flexible elastic material such as polyisoprene or silicone. A mounting flange 46 is integrally formed as a part of the body 44. The mounting flange 46 allows for both positioning with respect to the inner surface 48 of the housing 16 and sealing engagement with the inner surface 48 of the housing 16.

A cylindrical support wall 50 extends concentrically with the mounting flange 46 toward the outlet end 42 of the valve assembly 12. A pair of lip members, preferably a plurality of circumferentially spaced web members 52, are diametrically spaced from the cylindrical support wall 50 so as to join together to form a slit 54 that is normally closed. Direction, and extends axially outward (toward the distal end) toward the outlet end 42. It will be clear that the slit 54 forms a conventionally known crow-shaped sealing member 30.

The slit 54 is shown in a closed state in FIG. 3 and 4
In the slit 54, the guide wire (in the case of FIG. 3) or the catheter (in the case of FIG. 4) is disposed between the web members 52 so that the web members are pushed apart from each other in a forced open state. It is shown. In the closed condition, as the fluid pressure on the outlet end 42 of the web member 52 increases,
The slit 54 will be maintained in an increasingly tight occlusion. When guidewire 26 or catheter 24 is inserted through entry end 40, the guidewire or catheter will abut the edge of web member 52. Thereby, the slit 54 is opened, and the guide wire 26 or the catheter 24 can be inserted. The web member 52 can be opened with a large diameter,
Thus, even if the catheter 24 or another medical device having an outer diameter close to the inner diameter of the cylindrical support wall 50, the crow-shaped seal portion 30 is not torn, stretched, or otherwise damaged. Note that it can be inserted.

A pair of load forming ribs 56 located on the opposite side in the radial direction are provided between the cylindrical support wall 50 and the slit 54 in a direction crossing the slit 54, that is, the slit 54.
Extend in a direction perpendicular to. The load forming ribs 56 cooperate with the support wall 50 to stiffen or harden the web member 52. This provides resistance to opening of the slit 54 due to outward movement of the web member 52. In particular, the inward reaction force of the load-forming ribs 56 based on the cylindrical support wall 50 provides resistance to forces acting in the direction of spreading outward in the radial direction. This inward reaction force pushes the web members 52 toward each other toward the sealing condition, thereby preventing or minimizing blood leakage. In addition, the load forming ribs 56 may be used immediately after the guide wire 26 or the catheter 24 is withdrawn from the valve assembly 12.
This contributes to highly reliable closing of the web members 52.

Now, as shown in FIGS. 2 and 6 to 8, the second seal member 32, that is, the guide wire seal member, has a body 58 axially aligned with respect to the central shaft 38. . The guidewire seal member 32 has an inlet end forming the inlet end 40 of the valve assembly 12 and an outlet end 62. The body 58 is preferably provided with a flexible elastic material such as polyisoprene or silicone. The first mounting flange 64 and the second mounting flange 66 are connected to the body 58.
And are integrally formed as a part thereof. In this case, the first mounting flange 64 sealingly engages the inner surface 48 of the housing 16. The second mounting flange 66 sealingly engages a cylindrical spacer 68 made of the same material as the constituent material of the guide wire seal member 32 (FIG. 2). The guide wire seal member 32 is disposed between the third seal member 34, the spacer 68, and the lock cap 20 so that the axial movement and the radial movement of the guide wire seal member 32 are prohibited. Closely located within.

The cylindrical support wall 70 faces the outlet end 62 of the guide wire seal member 32,
It extends coaxially with the mounting flanges 64 and 66. The disk 72 extends radially inward from the support wall 70 and includes a lip member 74 illustrated as four in FIGS. 6 and 7 for illustration. The lip members 74 extend radially outward from the center shaft 38 and extend at equal intervals in the circumferential direction. Adjacent pairs of the lip members 74 of the lip members 74 are joined so as to form a slit 76 which is normally closed at the outlet end 62 of the guide wire sealing member 32. In a preferred embodiment, as shown in FIGS. 6 and 7, four slits 76a
, 76b, 76c, 76d are formed. The lip members 74, when combined with each other, form a circular plane 78 at the outlet end 62 and form a first and second pair of radially opposed slits 76. More specifically, the slits 76a and 76c form a first pair of radially opposite slits 76, and the slits 76b and 76d form a second pair of radially opposite slits 76. Form. In the preferred embodiment, plane 78
Has a diameter of about 5.08 mm (about 0.2 inches), so that each pair of radially opposed slits has a total of about 5.08 mm (about 0.2 inches) Has a length. Each slit pair 76a, 76c and 76
b and 76d are radially aligned with respect to the central axis 38. All slits 76 extend axially through plane 78 and each slit pair 76a
, 76c and 76b, 76d are arranged perpendicular to the other slit pairs 76b, 76d and 76a, 76c. Thereby, a cross-crossing slit that intersects with the center axis 38 as a center is formed.

The slit 76 is shown in a closed state in FIG. 2, FIG. 6, and FIG. In FIG. 4, the slit 76 is shown in a forced open state. In the closed condition, the lip members 74 sealingly engage each other, thereby preventing blood from passing between the lip members. When the catheter 24 is inserted from the entry end 40, the catheter 24 will abut the edge of the lip member 74. Thereby, the slit 76 is opened, and the catheter 24
Can be penetrated. The lip member 74 can be opened with a large diameter and the elastic body 58 allows the catheter 24 or other medical device having an outer diameter larger than the outer diameter of the circular flat surface 78 to be used. Guide wire seal 3
2 can be inserted without tearing, stretching or other damage. Furthermore, since the diameter (7.62 mm (0.3 inch)) of the catheter 24 exceeds the maximum width (5.08 mm (0.2 inch)) of the pair of slits 76, the guide wire sealing member is formed. The 32 forms a fluid tight seal against the catheter 24 when the catheter 24 is inserted.

Each lip member 74 has an arcuate notch 82 that cooperates with the arcuate notch 82 of each adjacent lip member 74 to form a central opening 84 coaxial with the longitudinal central axis 38. . The opening 84 has a circular cross-section and is smaller than the outer diameter of the guidewire 26 or any other medical instrument or device configured to allow the valve assembly 12 to be inserted therethrough. It is also a little smaller in diameter. Thus, opening 84 seals the periphery of the smallest diameter instrument or device through which catheter introducer 10 is typically inserted, such as guidewire 26. This can minimize or prevent blood spill when such a device is present in the valve assembly 12. In a preferred embodiment, opening 84 is about 0.889 mm (about 0.8 mm).
035 inches) to seal the periphery of the guidewire 26.
The diameter is 38 mm (about 0.033 inch).

A first pair 86 and a second pair 88 composed of load forming ribs located on radially opposite sides.
Extend radially inward from the cylindrical support wall 70. Load forming rib 86
, 88 preferably extend radially inward until abutting against lip member 74. Thereby, the movement resistance of the lip member 74 is optimized. As a result, the tendency of the lip members 74 adjacent to each other to maintain the seal engagement state and keep the slit 76 closed is increased. The first pair 86 of the load forming ribs is arranged perpendicular to the second pair 88 of the load forming ribs. Each pair of load forming ribs 86, 88 is preferably arranged at a predetermined angle, such as preferably 45 °, to each adjacent slit 76. Thereby, as described later, the seal engagement between the lip members 74 is facilitated.

The load forming ribs 86 and 88 preferably have an inclined upper surface 90 which is inclined downward from the cylindrical support wall 70 toward the opening 84. The inclination angle of the inclined upper surface 90 extending from the vicinity of the opening 84 to the support wall 70 is preferably 5 °.
It is. The inclined upper surface 90 is located between the second seal member 32 and the third seal member 34.
This results in a clearance gap 89 (FIG. 2). Due to the clearance gap 89, when only the guide wire 26 is inserted through the second seal member as shown in FIG. 3, the load forming ribs 86 and 88 substantially displace the third seal member 34. Is blocked. The outer end of the inclined upper surface 90 is connected to the upper surface 92 of the support wall 70.
And the inner end of the inclined upper surface 90 is located on the flat surface 7 of the disk 72.
It is the same height position as 8,

The load forming ribs 86, 88 cooperate with the support wall 70 to stiffen or harden the disk 72. This provides resistance to the force of opening the slit 76 by the outward movement of the lip member 74. In particular, the ribs 86, 88 and the support wall 70 hold the slits 76 in sealing engagement with each other so that the pressure of blood exerted against the outlet end 62 can be counteracted. In addition, the load forming ribs 86 and 88 contribute to highly reliable closing of the lip members 74 immediately after the catheter 24 is pulled out of the guide wire sealing member 32. The load forming ribs 86 and 88 are formed such that the guide wire 26 has the opening 8.
In the course of passing through the slit 4, the slits 76 continue to be closed in the seal engagement state. Load forming ribs 86, 88, slit pair 76a,
An offset angle (angular misalignment) of 45 ° between each of 76c and 76b, 76d optimizes immunity to forces that push lip member 74 apart.

The guide wire seal member 32 has a substantially hemispherical recess 94.
The recess 94 opens toward the inlet end 40 to guide the distal end of the guidewire 26 or the distal end of the catheter 24 into the opening 84 when the guidewire 26 or the catheter 24 is introduced into the catheter assembly 12. I have. The valve disc 72 has opposing inner and outer surfaces 96 and 98 disposed toward the inlet end 60 and outlet end 62, respectively. The inner surface 96 is the entrance end 4
It is substantially hemispherical from near 0 to the opening 84. As a result, a recess 94 is formed. Because the hemispherical inner surface 96 extends radially inward to the opening 84, the guide wire 26 is inserted into the slit 76 where the tip of the guide wire 26 is located between the lip members 74. It is guided through the opening 84 while sealingly engaging the opening 84 without trying to forcibly open the slit 76 due to contact with the opening. Outer surface 98 is substantially hemispherical from support wall 70 to plane 78. Thus, the load forming ribs 86 adjacent to each other are formed.
, 88 are formed between the plurality of arc-shaped recesses 100 (FIG. 6).

Now, as shown in FIGS. 2, 9, and 10, the third seal member 34, ie, the disc-shaped seal member for the catheter, is provided between the squeezed seal member 30 and the guide wire seal member 32. , Are arranged in a sealing engagement state. Also in this case, the catheter disk-shaped seal member 34 preferably includes a body 102 formed of a flexible elastic material such as polyisoprene or silicone. A mounting flange 104 is integrally formed as a part of the body 102. In this case, the mounting flange 104 sealingly engages the inner surface 48 of the housing 16. As shown in FIG. 2, the catheter disc-shaped seal member 34 includes a guide wire seal member 32, a spacer 68, and a mouthpiece so that axial displacement and radial displacement of the catheter disc-shaped seal member 34 are prohibited. The sealing member 30 is tightly arranged in the housing 16.

The body 102 includes a cylindrical support wall 106 and a disk 108 extending radially inward from the support wall 106. The disk 108 has an opening 110 coaxial with the longitudinal central axis 38. Opening 110 has a diameter that is substantially larger than the outer diameter of guidewire 26, but smaller than the outer diameter of catheter 24 so as to allow for a seal engagement between disk 108 and catheter 24. ing. In a preferred embodiment, the diameter of the aperture 110 is equal to about 0.075 inches (1.905 mm). The disk 108 has an inner surface 112 and an outer surface 114 that are both substantially planar. It has been found that the addition of the catheter seal member 34 assists in forming a seal at the periphery of the medical device having the outer diameter intermediate the opening 110 and the catheter 24 and through which the valve assembly 12 is inserted. Was.

FIGS. 2-4 illustrate each of three different modes of operation of the valve assembly 12 according to the present invention. FIG. 2 illustrates a first mode of operation, in which no guidewire 26, no catheter 24, or any other medical device has been inserted into the valve assembly 12. In the first mode, the aperture 8
It is clear that 4 and aperture 110 are coaxially aligned and fluid communication is possible between catheter disc seal member 34 and guide wire seal member 32. However, the web member 5 of the mouth-shaped sealing member 30
2 occlude the slit 54 so that blood flow through the catheter introducer 10 from the outlet end 42 is prevented or minimized.

FIG. 3 shows a second mode of operation, in which case the valve assembly 12
Only the guide wire 26 is disposed therein. In this second mode, the guidewire seal member 32 provides the primary seal around the outer surface of the guidewire 26, and thus the exit end 42 through the catheter introducer 10.
Outflow from the blood is blocked or minimized. As described above, guidewire 26 has a relatively small diameter, typically about 0.035 inches. Therefore, the relatively large diameter opening of the catheter disk-shaped sealing member 34 does not sealingly engage the outer surface of the guidewire 26. Further, as described above, the flared seal member 30 provides only a partial seal around the guide wire 26. However, since the diameter of the opening 84 of the guide wire seal member 32 is smaller than the outer diameter of the guide wire 26, a seal engagement is formed between the guide wire seal member 32 and the guide wire 26. You. The slits 76 are simultaneously pressed together by the load forming ribs 86 and 88 into the sealing engagement state.

The third mode of operation is defined as the state in which the catheter 24 is inserted into the valve assembly 12 as shown in FIG. As described above, the catheter 24
It has a relatively large outer diameter, typically on the order of 0.3 inches. As the catheter 24 is guided over the guidewire 26 from the entry end 40 to the exit end 42, the catheter 24 is in sealing engagement with the guidewire seal member 32 because of the resilient body 58 and the lip member 74. The guide wire sealing member 32 can be easily inserted while performing. Since the diameter of the catheter 24 exceeds the maximum width of the opening formed by the slit pair 76 of the guide wire sealing member 32, and the opening 110 of the catheter disc-shaped sealing member 34
When the catheter 24 is inserted through the valve assembly 12, both the guide wire sealing member 32 and the catheter disk-shaped sealing member 34 are fluid-tight with respect to the catheter 24. Form a realistic seal.

As will be appreciated, when a medical device having an outer diameter intermediate between the outer diameter of the guidewire 26 and the width of the slit pair 76 is inserted through the valve assembly 12,
The opening of the slit 76 may allow limited fluid communication between the guidewire seal member 32 and the catheter disk-shaped seal member 34. In such a case, if the medical device has an outer diameter greater than the diameter of the opening 110, the catheter disc-shaped sealing member 34 provides a primary seal around the outer surface of the medical device.

From the above description, it will be apparent that a hemostasis valve assembly may be provided that is receivable within a catheter introducer. The valve assembly is
The blood outflow through the introducer is continuously sealed. More specifically, the valve assembly is capable of receiving a relatively large diameter catheter within the assembly, whether an instrument is not inserted through the assembly, a relatively small diameter guidewire is passed through the assembly, or the like. Seal blood spills even if they are. Furthermore, the valve assembly according to the present invention includes a guide wire sealing member configured to be capable of sealingly engaging the guide wire while having the performance of facilitating the insertion of the catheter.

Although the device configurations disclosed herein form preferred embodiments of the invention, the invention is not limited to the details of these device configurations, and is defined by the claims. It will be understood that various modifications can be made to the above device configuration without departing from the scope of the invention.

[Brief description of the drawings]

FIG. 1 is a cross-sectional view showing a catheter introducer including a valve assembly according to the present invention.

FIG. 2 is a sectional view showing a valve assembly according to the present invention, showing a first operation mode.

FIG. 3 is a cross-sectional view showing a valve assembly according to the present invention, showing a second operation mode when a guide wire is disposed inside;

FIG. 4 is a cross-sectional view illustrating a valve assembly according to the present invention, illustrating a third mode of operation when a catheter is disposed therein.

FIG. 5 is a crow-shaped sealing member (first embodiment) in the valve assembly according to the present invention.
It is a top view which shows a (seal member).

FIG. 6 is a perspective view showing a guide wire seal member (second seal member) according to the present invention.

FIG. 7 is a plan view showing a guide wire sealing member according to the present invention.

8 is a cross-sectional view showing the seal member for a guide wire of the present invention along a cross section taken along line 8-8 in FIG. 7;

FIG. 9 is a bottom view showing a catheter disk-shaped seal member (third seal member) in the valve assembly according to the present invention.

FIG. 10 is a plan view of the disc-shaped sealing member for a catheter shown in FIG. 9;

[Explanation of symbols]

 Reference Signs List 10 catheter introducer 12 hemostatic valve assembly 16 housing 24 catheter (long member) 26 guide wire 28 valve body 30 first seal member, flared seal member 32 second seal member, guide wire seal member 34 third seal member, Catheter disk-shaped sealing member 36 Central passage 38 Length axis, center axis 40 Inlet end 42 Outlet end 44 Body 50 Cylindrical support wall 52 Web member (lip member) 54 Slit 56 Load forming rib 58 Body 70 Cylindrical support wall 72 disk 74 lip member 76 slit 76a-76d slit 84 opening 86 a first pair of load forming ribs located on the radially opposite side 88 a second pair of load forming ribs located on the radially opposite side Vs. 90 inclined top surface 94 hemispherical recess (half Jo inner surface) 102 body 106 cylindrical support wall 108 disc 110 opening

[Procedural Amendment] Submission of translation of Article 34 Amendment of the Patent Cooperation Treaty

[Submission date] April 27, 2000 (2000.4.27)

[Procedure amendment 1]

[Document name to be amended] Statement

[Correction target item name] Claims

[Correction method] Change

[Correction contents]

[Claims]

22. A sealing member, with has a central longitudinal axis, an inlet end and has an outlet end, it comprises a resilient body, the body, the said inlet end A cylindrical support wall extending in the axial direction between the outlet end and four radially extending lip members which are circumferentially separated from each other and which are orthogonal to each other; Forming two slits arranged and intersecting, and an opening coaxial with the longitudinal central axis, the opening being coaxial with the longitudinal central axis, When only the first elongate member having the first diameter is disposed in the seal member, the first elongate member is sealingly engaged with the first elongate member in order to prevent fluid outflow through the seal member. Is configured so that The slot is configured to allow insertion of a second elongate member having a second diameter greater than the first diameter, and further extends from the support wall toward the opening and extends radially from each other. A first pair and a second pair of load forming ribs located on opposite sides, each of the first pair and the second pair being offset by a predetermined angle with respect to the slit; , The lip members can be pressed against each other in a seal-engaging direction, and further comprising a substantially hemispherical inner surface, the inner surface extending into the opening into the first elongate member. A seal member, which is open from the vicinity of the opening toward the inlet end so as to guide the lip member, and wherein the inner surface positions the lip member at a distance from the inlet end.

Claims (21)

[Claims] 1. A hemostatic valve assembly for use in a device comprising a housing for positioning an elongate member guided by a guidewire into a patient's body, comprising a first seal member and a second seal. A valve body comprising a member, and having a central passage having a longitudinal central axis, and an inlet end and an outlet end opposed to each other, wherein the inlet end is The first seal member includes an elastic body, the elastic body includes a cylindrical support wall extending in an axial direction, A plurality of lip members extending radially inward from the support wall and extending in the axial direction in a direction from the inlet end to the outlet end, wherein the lip members extend circumferentially. At least one normally closed slit extending transversely to the central passage to prevent fluid outflow from the housing through the valve assembly. The second seal member comprises an elastic body, the elastic body having a cylindrical support wall extending in the axial direction, and a plurality of lips separated from each other in the circumferential direction and extending in the radial direction. A lip member defining at least one slit extending transversely to the central passage and an opening coaxial with the longitudinal central axis; An opening is provided in the hemostatic valve assembly when the guidewire is disposed within the second seal member and the elongated member is not present within the second seal member. Adapted to sealingly engage the guidewire to prevent fluid outflow from the housing through the web member, the web member being the at least one normal closure of the first seal member A mold slit is positioned at a distance from the at least one slit of the second seal member, whereby the web member of the first seal member is
A hemostasis valve assembly, wherein the hemostasis valve assembly does not interfere with the opening of the lip member of the second seal member. 2. The hemostasis valve assembly according to claim 1, wherein the hemostasis valve assembly further comprises a third seal member, wherein the third seal member comprises an elastic body, wherein the elastic body comprises a cylinder. A support wall and a disk extending radially inward from the support wall, the disk forming an opening coaxial with the longitudinal center axis; Sealingly engages the elongate member to prevent fluid outflow from the housing through the hemostatic valve assembly when the elongate member is disposed within the third seal member. A hemostatic valve assembly configured to obtain a hemostatic valve assembly. 3. The hemostasis valve assembly according to claim 2, wherein the first seal member forms the outlet end, the second seal member forms the inlet end, and the third seal member comprises A hemostasis valve assembly, wherein the hemostasis valve assembly is disposed between the first seal member and the second seal member. 4. The hemostasis valve assembly according to claim 1, wherein said elastic body of said first seal member further comprises at least one load forming member between said cylindrical support wall and said at least one slit. A hemostasis valve assembly comprising a rib, wherein the load forming rib presses at least two of the plurality of lip members in a direction in which they are in sealing engagement with each other. 5. The hemostasis valve assembly according to claim 1, wherein the at least one slit of the second seal member intersects the opening. 6. The hemostasis valve assembly according to claim 1, wherein the plurality of lip members of the second seal member are four lip members extending in a radial direction, and the four lip members are the openings. 1 that intersect and are orthogonal to each other
A hemostatic valve assembly comprising a pair of slits. 7. The hemostasis valve assembly according to claim 1, wherein the elastic body of the second seal member further extends from the cylindrical support wall and from the cylindrical support wall to the opening. At least one load-forming rib extending radially inward, wherein the load-forming rib faces at least two of the plurality of lip members in a sealing engagement with each other. Pressurizing the hemostatic valve assembly. 8. The hemostasis valve assembly according to claim 7, wherein said at least one load forming rib has a first pair and a second pair of radially opposite load forming ribs. A hemostasis valve assembly, characterized in that: 9. The hemostasis valve assembly according to claim 8, wherein each of the first pair and the second pair of the load forming ribs located on the radially opposite side are arranged with respect to the at least one slit. A hemostasis valve assembly offset by a predetermined angle. 10. The hemostasis valve assembly according to claim 1, wherein said elastic body of said second seal member further comprises a substantially hemispherical inner surface, said inner surface connecting said guidewire to said opening. A hemostatic valve assembly open to the inlet end for guidance, wherein the inner surface locates the lip member of the second seal member away from the inlet end; . 11. The hemostasis valve assembly according to claim 10, wherein said inner surface extends toward said opening. 12. A seal member, comprising a resilient body having a central longitudinal axis and having an inlet end and an outlet end, wherein the body includes the elastic member and the seal member. A cylindrical support wall extending in the axial direction between the outlet end and a plurality of radially extending lip members that are arranged separately from each other in the circumferential direction; Forming one slit and an opening, wherein the opening is coaxial with respect to the central axis in the longitudinal direction, and only a first elongated member having a first diameter is disposed in the seal member. The at least one slit is adapted to sealingly engage the first elongate member to prevent fluid outflow through the seal member when the first elongate member is closed. Second diameter greater than Seal member characterized by being configured to may allow insertion of the second elongate member having. 13. The seal member according to claim 12, wherein the at least one slit intersects the opening. 14. The seal member according to claim 12, wherein the plurality of lip members are four lip members extending in a radial direction, and the four lip members intersect the opening and are orthogonal to each other. Done 1
A seal member characterized by forming a pair of slits. 15. The seal member according to claim 12, further comprising at least one load forming rib extending from the support wall toward the opening, wherein the load forming rib includes the plurality of load forming ribs. A sealing member for pressing at least two of the lip members in a direction in which they are in sealing engagement with each other. 16. The seal member according to claim 15, wherein the at least one load forming rib has a first pair and a second pair of load forming ribs located on radially opposite sides. A seal member characterized by the above-mentioned. 17. The seal member according to claim 16, wherein each of the first pair and the second pair of the load forming ribs located on the opposite side in the radial direction is predetermined with respect to the at least one slit. A seal member offset by an angle. 18. The seal member according to claim 12, wherein said body further comprises a substantially hemispherical inner surface, said inner surface proximate said opening to guide said guidewire to said opening. A seal member, which is open toward the inlet end from above, and wherein the inner surface positions the lip member away from the inlet end. 19. The seal member according to claim 18, wherein the inner surface extends toward the opening. 20. The seal member according to claim 16, further comprising: a valve disk having a substantially hemispherical outer surface and formed by the lip member, and an adjacent one of the plurality of load forming ribs. A plurality of arc-shaped recesses formed between the seal members. 21. A seal member, comprising a resilient body having a central longitudinal axis and having an inlet end and an outlet end, wherein the body has an inlet end and an outlet end. A cylindrical support wall extending in the axial direction between the outlet end and four radially extending lip members which are circumferentially separated from each other and which are orthogonal to each other; Forming two slits arranged and intersecting, and an opening coaxial with the longitudinal central axis, the opening being coaxial with the longitudinal central axis, When only the first elongate member having the first diameter is disposed in the seal member, the first elongate member is sealingly engaged with the first elongate member in order to prevent fluid outflow through the seal member. Is configured so that Is configured to allow insertion of a second elongated member having a second diameter larger than the first diameter, and further extends from the support wall toward the opening and is radially opposite to each other. A first pair and a second pair of load forming ribs located on the sides, each of the first pair and the second pair being offset by a predetermined angle with respect to the slit, The lip members are adapted to be pressed in a sealing engagement with each other, and further comprise a substantially hemispherical inner surface, which may guide the guidewire into the opening. The seal member is open from the vicinity of the opening toward the entrance end, and the inner surface is located at a position separated from the entrance end by the lip member.