Guide device for a blood vessel catheter

Abstract

A guide device for a vascular catheter inserted over a guidewire. The guide device includes a tapered component that passes through a bore of the vascular catheter and extends from its distal end. The tapered component has an opening through which the guidewire can pass so that the tapered component can move along the guidewire. A pushing means extends from the tapered component and is configured to extend beyond the proximal end of the vascular catheter. The tapered component includes a first section, a second section, and a third section. The first section is disposed between the proximal end of the tapered component and the second section, the second section is disposed between the first section and the third section, and the third section is disposed between the second section and the distal end of the tapered component. The first section is cylindrical, and the second and third sections are conical. The taper of the second section is different from the taper of the third section.

Description

Technical Field

[0001] The present invention relates to a guide device for a vascular catheter, and more particularly to a guide device that can facilitate improved passage of a catheter through a blood vessel.

Background Art

[0002] Arterial diseases are currently the leading causes of death in the UK and worldwide. This occurs due to stenosis caused by the accumulation of fatty deposits (atherosclerosis). The coronary arteries run along the surface of the heart and supply blood to the myocardium. For example, stenosis associated with coronary heart disease can restrict blood flow, which may result in an insufficient supply of vital oxygen to the myocardium. To access the coronary arteries or other arteries, physicians need to insert a catheter into the vascular system. For access to the coronary arteries, as the most common vascular intervention, catheters have conventionally been inserted via the femoral artery. More recently, the use of the radial artery has become more common. The most common procedure for treating coronary heart disease is called coronary angioplasty or percutaneous coronary intervention (PCI) (commonly known as "stenting").

[0003] In such a procedure, the stenosis of the coronary artery is identified by injecting a contrast agent under X-ray guidance. The balloon is inflated to relieve the stenosis, and a stent (a metal mesh tube) is inserted. The stent serves to keep the artery open and blood flow is restored. In the UK, approximately 100,000 PCI procedures are performed annually.

[0004] A catheter is used to deliver a contrast agent and an angioplasty device including a wire, a balloon, and a stent. Due to its technical requirements, a vascular catheter is often made of a relatively hard material and formed into a cylindrical tube. When advancing a vascular catheter through an artery in the arm, the so-called "razor blade effect" often occurs, where the edge of the vascular catheter rubs against the artery wall. This is painful for the patient and can cause the artery to spasm and lead to complications such as snagging and serious bleeding.

[0005] When spasm or snagging occurs, a combination of a sedative, an analgesic (e.g., opiate), and a vasodilator is administered to the patient, but the procedure is often delayed. Depending on the situation, the procedure may need to be performed through another artery or completely abandoned. When performing the procedure through the femoral artery instead, the risk of bleeding and serious complications is further increased.

[0006] The prior art provides certain solutions to facilitate the reduction of risks arising from some of these problems, but such solutions often require expensive devices. Furthermore, many prior art solutions are not compatible with standard instruments and are only compatible with specific catheter hardware, so multiple devices are required to be able to select the appropriate one for use with a specific catheter.

[0007] An object of certain embodiments of the present invention is to overcome at least some of the disadvantages associated with the prior art.

Summary of the Invention

[0008] According to a first aspect of the present invention, there is provided a guide device for a vascular catheter inserted onto a guide wire, the guide device comprising a tapered component that passes through a hole of the vascular catheter and extends from its distal end, the tapered component having an opening through which the guide wire can pass so that the tapered component can move along the guide wire, It includes an extrusion means extending from the tapered component and configured to extend beyond the proximal end of the blood vessel catheter. The tapered component includes a first section, a second section, and a third section. The first section is disposed between the proximal end of the tapered component and the second section. The second section is disposed between the first section and the third section. The third section is disposed between the second section and the distal end of the tapered component. The first section is cylindrical, the second section and the third section are conical, and the taper of the second section is different from the taper of the third section.

[0009] In certain embodiments, the second section can be a convex conical section. The third section can be a concave conical section. In certain embodiments, the proximal end of the first section can coincide with the proximal end of the tapered component. The diameter of the first section may be the maximum diameter of the tapered component. In certain embodiments, the distal end of the third section can coincide with the distal end of the tapered component. The minimum diameter of the tapered component can coincide with the distal end of the third section.

[0010] The movement of the tapered component along the guide wire can be controllable in the proximal direction beyond the proximal end of the blood vessel catheter by the movement of the extrusion means.

[0011] The guide device may comprise a connector connectable to the extrusion means for removably connecting the guide device to the proximal end of the vascular catheter. The connector may comprise a freewheel mechanism configured to allow the connector to be connected to the proximal end of the vascular catheter without rotating the extrusion means. In certain embodiments, the connector can comprise a body connectable to the extrusion means and a freewheel ring for connection to the catheter. The freewheel ring may be axially restricted relative to the body of the connector and may be free to rotate around the body of the connector. The rim may restrict the freewheel ring in the distal direction relative to the body of the connector. The connector may be movable along the extrusion means.

[0012] In certain embodiments, the extrusion means may have a non-circular cross-section. The cross-section of the extrusion means may have a plurality of sides. The cross-section of the extrusion means may have four sides. The lengths of adjacent sides may be different. The angles between adjacent sides may be rounded. In certain embodiments, the plurality of sides may include a first curved side. The first curved side may coincide with a part of the circumference of the outer surface of the proximal end of the tapered component.

[0013] In certain embodiments, the guide device may comprise a bore accessible through an opening. The plurality of sides of the extrusion means may include a second curved side that coincides with a part of the circumference of the bore of the tapered component.

[0014] In certain embodiments, the extrusion means may be arranged such that a portion of the guide wire radially adjacent to the extrusion means remains visible to the surgeon during use.

[0015] According to a second aspect of the present invention, there is provided a guide device for a vascular catheter to be inserted over a guide wire, the guide device comprising a tapered component passing through the lumen of the vascular catheter and extending from its distal end, the tapered component having an opening through which the guide wire can pass such that the tapered component can move along the guide wire. It includes an extrusion means having a non-circular cross-section, extending from a tapered component, and configured to extend beyond the proximal end of the blood vessel catheter. The movement of the tapered component along the guide wire can be controlled beyond the proximal end of the blood vessel catheter by the movement of the extrusion means.

[0016] In certain embodiments, the cross-section of the extrusion means may have a plurality of sides. The cross-section of the extrusion means may have four sides. The lengths of adjacent sides may be different. The angles between adjacent sides may be rounded. In certain embodiments, the plurality of sides may include a first curved side. The first curved side may coincide with a part of the circumference of the outer surface of the proximal end of the tapered component.

[0017] In certain embodiments, the guide device may comprise a bore accessible through an opening. The plurality of sides of the extrusion means may include a second curved side that coincides with a part of the circumference of the bore of the tapered component.

[0018] The guide device may comprise a connector connectable to the extrusion means for removably connecting the guide device to the proximal end of the blood vessel catheter. In certain embodiments, the connector may comprise a freewheel mechanism configured to allow the connector to be connected to the proximal end of the blood vessel catheter without rotating the extrusion means. In certain embodiments, the connector may comprise a body connectable to the extrusion means and a freewheel ring for connecting to the catheter. The freewheel ring may be axially restricted with respect to the body of the connector and can rotate freely around the body of the connector. The rim may restrict the freewheel ring in the distal direction with respect to the body of the connector. The connector may be movable along the extrusion means.

[0019] In certain embodiments, the tapered component can include a first section, a second section, and a third section. The first section can be disposed between the proximal end of the tapered component and the second section. The second section can be disposed between the first section and the third section. The third section can be disposed between the second section and the distal end of the tapered component. The first section can be cylindrical. The second and third sections can be conical, and the taper of the second section can be different from the taper of the third section.

[0020] In certain embodiments, the second section can be a convex conical section. The third section can be a concave conical section. In certain embodiments, the proximal end of the first section can coincide with the proximal end of the tapered component. The diameter of the first section can be the maximum diameter of the tapered component. In certain embodiments, the distal end of the third section can coincide with the distal end of the tapered component. The minimum diameter of the tapered component can coincide with the distal end of the third section.

[0021] In certain embodiments, the pushing means can be arranged such that a portion of the guide wire radially adjacent to the pushing means remains visible to the surgeon during use.

[0022] According to a third aspect of the present invention, there is provided a guide device for a vascular catheter to be inserted over a guide wire, the guide device comprising a tapered component passing through the lumen of the vascular catheter and extending from its distal end, the tapered component having an opening through which the guide wire can pass so that the tapered component can move along the guide wire; pushing means extending from the tapered component and configured to extend beyond the proximal end of the vascular catheter; and a connector for removably connecting the guide device to the proximal end of the vascular catheter. The connector is connectable to an extrusion means and comprises a freewheel mechanism configured to enable the connector to be connected to the proximal end of a blood vessel catheter without rotating the extrusion means. The movement of a tapered component along a guide wire can be controlled beyond the proximal end of the blood vessel catheter by the movement of the extrusion means.

[0023] In certain embodiments, the connector can comprise a body connectable to an extrusion means and a freewheel ring for connection to a catheter. The freewheel ring can be axially restricted relative to the body of the connector and can rotate freely around the body of the connector. The rim can restrict the freewheel ring distally relative to the body of the connector. The connector can be movable along the extrusion means.

[0024] In certain embodiments, the extrusion means can have a non-circular cross-section. The cross-section of the extrusion means can have a plurality of sides. The cross-section of the extrusion means can have four sides. The lengths of adjacent sides can be different. The angles between adjacent sides can be rounded. In certain embodiments, the plurality of sides can include a first curved side. The first curved side can coincide with a part of the circumference of the outer surface of the proximal end of the tapered component.

[0025] In certain embodiments, the guide device can comprise a bore accessible through an opening. The plurality of sides of the extrusion means can include a second curved side that coincides with a part of the circumference of the bore of the tapered component.

[0026] In certain embodiments, the tapered component can include a first section, a second section, and a third section. The first section can be disposed between the proximal end of the tapered component and the second section. The second section can be disposed between the first section and the third section. The third section can be disposed between the second section and the distal end of the tapered component. The first section can be cylindrical. The second and third sections can be conical, and the taper of the second section can be different from the taper of the third section.

[0027] In certain embodiments, the second section can be a convex conical section. The third section can be a concave conical section. In certain embodiments, the proximal end of the first section can coincide with the proximal end of the tapered component. The diameter of the first section can be the maximum diameter of the tapered component. In certain embodiments, the distal end of the third section can coincide with the distal end of the tapered component. The minimum diameter of the tapered component can coincide with the distal end of the third section.

[0028] In certain embodiments, the extrusion means can be arranged such that a portion of the guide wire radially adjacent to the extrusion means remains visible to the surgeon during use.

[0029] In any of the first, second, and third aspects of the present invention, the tapered component can have a low-friction outer surface. In certain embodiments, the low-friction outer surface can include a hydrophilic outer surface.

[0030] In certain embodiments, the extrusion means can include a wire extending from the tapered component.

[0031] In certain embodiments, the tapered component can have an axial length between 10 cm and 30 cm, and optionally between 14 cm and 25 cm. In certain embodiments, the tapered component can have an axial length of about 20 cm.

[0032] The extrusion means can optionally extend at least 60 cm, at least 70 cm, at least 80 cm, at least 90 cm, or at least 100 cm from the tapered component.

[0033] In certain embodiments, the opening can be sized such that a guide wire having a diameter of 0.46 mm (0.018”), 0.64 mm (0.025”), 0.81 mm (0.032”), 0.89 mm (0.035”), 0.97 mm (0.038”), or 1.10 mm (0.043”) can pass through.

[0034] The tapered component can have a maximum diameter of less than 3.00 mm, less than 2.7 mm, less than 2.29 mm, less than 2.0 mm, less than 1.7 mm, or less than 1.35 mm. In certain embodiments, the maximum outer diameter can coincide with the proximal end of the tapered component, and the tapered component can be tapered from the minimum outer diameter to the maximum outer diameter at the distal end of the tapered component.

[0035] The guide device can further comprise a radiopaque material. In certain embodiments, the tapered component can comprise a radiopaque material. In non-limiting embodiments, the radiopaque material can be barium sulfate. In certain embodiments, the guide device can further comprise one or more markers. The one or more markers can include one or more radiopaque markers for indicating the position of a portion of the guide device under fluoroscopic screening. The one or more radiopaque markers can be disposed on the tapered component. In alternative embodiments, the one or more markers can be provided on the extrusion means, for example, to indicate the deployed length of the guide device. In certain embodiments, the guide means can include an ink or physical band that causes the distal end of the tapered component to be recognized by X-ray and other medical imaging techniques.

[0036] In certain embodiments, the tapered component can comprise a plastic material.

[0037] In certain embodiments, the extrusion means may comprise a metal and / or plastic material.

[0038] According to another aspect of the present invention, a guide device as described above, and a vascular catheter, are provided in a kit, wherein the tapered component of the guide device is configured to pass through the lumen of the vascular catheter and extend from its distal end.

[0039] The kit may further include a guide wire, and the opening of the tapered component may permit passage of the guide wire therethrough such that the tapered component can move along the guide wire.

[0040] According to another aspect of the present invention, a guide device as described above, and a guide wire, are provided in a kit, wherein the opening of the tapered component permits passage of the guide wire therethrough such that the tapered component can move along the guide wire.

[0041] Embodiments of the present invention are further described below with reference to the accompanying drawings.

Brief Description of the Drawings

[0042]

Fig. 1A

Fig. 1B

Fig. 2

Fig. 3

Fig. 4

Fig. 5

Fig. 6

Fig. 7

Fig. 8

DETAILED DESCRIPTION OF THE INVENTION

[0043] Figures 1A and 1B show schematic side views of a guide device 10 according to an embodiment of the present invention. The guide device 10 can facilitate the improved passage of a vascular catheter through a peripheral blood vessel (e.g., the radial artery).

[0044] The guide device 10 extends along a longitudinal axis 100 between a proximal end 10a and a distal end 10b. Throughout this specification, references to the front or distal direction (and the like) relate to a direction parallel to the longitudinal axis 100 and toward the distal end 10b (or away from the proximal end 10a). Similarly, references to the rear or proximal direction (and the like) relate to a direction parallel to the longitudinal axis 100 and toward the proximal end 10a (or away from the distal end 10b). References to the axial direction and the like relate to a direction parallel to the longitudinal axis 100. References to the radial direction and the like relate to a direction extending perpendicular to the longitudinal axis 100, and a radially outward position is further away from the longitudinal axis 100 than a radially inward position. References to the circumferential direction and the like relate to a path following the circumference (part or all) of a conceptual circle, the plane of which extends perpendicular to the longitudinal axis 100.

[0045] The guide device 10 comprises a tapered component 12 extending generally along the longitudinal axis 100 from a proximal end 12a to a distal end 12b. In the non-limiting embodiment shown in the figures, the distal end 12b of the tapered component 12 coincides with the distal end 10b of the guide device 10. The tapered component 12 is tapered (i.e., the diameter increases) from the minimum diameter at its distal end 12b to a larger diameter behind the distal end 12b. In a particular embodiment, the maximum diameter may coincide with the proximal end 12a of the tapered component 12.

[0046] In certain embodiments, the shape of the taper varies along the tapered component 12 between the proximal end 12a and the distal end 12b. In the embodiment shown in FIG. 2, the tapered component 12 includes a first section 15, a second section 17, and a third section 19. Each section has a different shape. However, the final outer profile of the tapered component 12 is continuous along a direction parallel to the longitudinal axis 100. The first section 15 is disposed between the proximal end 12a of the tapered component 12 and the second section 17. In the embodiment shown in FIG. 2, the first section 15 is cylindrical. That is, the cross-section of the first section is substantially uniform along its length. The proximal end of the first section 15 may coincide with the proximal end 12a of the tapered component 12. In certain embodiments, the diameter of the first section 15 may be the maximum diameter of the tapered component 12. The second section 17 is disposed between the first section 15 and the third section 19. In the embodiment shown in FIG. 2, the second section 17 is in the shape of a convex cone. That is, the taper profile of the cone follows a convex curve. The diameter of the cross-section of the convex cone decreases while increasing the rate of decrease. The maximum diameter of the second section 17 coincides with the proximal end of the second section 17, and the diameter of the second section decreases in the distal direction. In certain embodiments, the diameter of the proximal end of the second section 17 may be equal to the diameter of the first section 15. The third section 19 is disposed between the second section 17 and the distal end 12b of the tapered component 12. In the embodiment shown in FIG. 2, the third section is in the shape of a concave cone. That is, the taper profile of the cone follows a concave curve. The diameter of the cross-section of the concave cone decreases while decreasing the rate of decrease. The maximum diameter of the third section 19 coincides with the proximal end of the third section 19, and the diameter of the third section 19 decreases in the distal direction. In certain embodiments, the diameter of the proximal end of the third section 19 may be equal to the diameter of the distal end of the second section 17. The distal end of the third section 19 may coincide with the distal end 12a of the tapered component 12. In certain embodiments, the minimum diameter of the tapered component 12 may be the diameter of the distal end of the third section 19.The above shape of the tapered component 12 provides improved flexibility compared to the prior art, enabling it to effectively navigate blood vessels. As a result, in certain embodiments, the tapered component 12 can be manufactured without the need to vary the material or material properties (e.g., hardness) along its length.

[0047] In other embodiments, the tapered component can take any alternative shape that can provide the required flexibility. In alternative embodiments, the tapered component can include a different number of sections. For example, a fourth section can extend distally from the third section. The fourth section (not shown) can take the form of a cylinder. Additionally or alternatively, a fifth section can extend proximally from the first section. The fifth section (not shown) can take the form of a cylinder. In certain embodiments, additional sections can be disposed in at least one of the spaces between the first section 15 and the second section 17, and between the second section 17 and the third section 19. Further, the shape of each section can take a different form. The second section 17 can take the form of a cone (i.e., the taper profile of the cone follows a straight line). Alternatively, the second section 17 can take the form of a concave cone, or the second section 17 can have a rounded taper or a parabolic taper. The third section 19 can take the form of a cone (i.e., the taper profile of the cone follows a straight line). Alternatively, the third section 19 can take the form of a convex cone, or the third section 19 can have a rounded taper or a parabolic taper. In certain embodiments, the taper of the second section 17 can be different from the taper of the third section 19. For example, the taper of the second section 17 can be (at least partially) steeper than the taper of the third section 19 with respect to the longitudinal axis 100.

[0048] The tapered component 12 includes an opening 13 at its distal end 12b. The tapered component 12 is hollow such that the inner bore 13a of the tapered component 12 is accessible through the opening 13. The inner bore 13a of the tapered component 12 extends to the proximal end 12a of the tapered component 12, such that it is also accessible from the proximal end 12a. Thus, the inner bore 13a extends through all sections of the tapered component 12. The inner bore 13a may have a constant diameter from the proximal end 12a to the distal end 12b of the tapered component 12. The inner bore 13a is accessible through a second opening 13b at the proximal end 12a of the tapered component 12. A wall 12c can extend between the inner bore 13a of the tapered component 12 and the outer surface of the proximal end 12a. In certain embodiments, at least a portion of the wall 12c can be substantially perpendicular to the longitudinal axis 100. Additionally or alternatively, at least a portion of the wall 12c may be inclined with respect to the longitudinal axis 100. Thus, the wall 12c can provide a tapered opening for the second opening 13b.

[0049] The guiding device 10 also comprises an extrusion means 14 (e.g., an extruder in the form of an extrusion component or an assembly of components) extending rearward from the tapered component 12. The extrusion means 14 may extend from a position on the tapered component 12 axially forward of the proximal end 12a of the tapered component 12. The extrusion means 14 may be inserted into a groove of the tapered component 12. The extrusion means 14 has sufficient rigidity to move the tapered component 12 both forward and backward through the blood vessel when the extrusion means 14 extends proximally out of the blood vessel (and out of the body) from the tapered component 12. Despite such rigidity, the extrusion means 14 is also sufficiently flexible such that it can bend and follow the contour of the blood vessel as it passes through the blood vessel.

[0050] The guide device 10 further includes a connector 18 connected to the extrusion means 14. The connector 18 can facilitate easier handling and movement of the extrusion means 14 from outside the blood vessel. The connector 18 can be configured to removably connect the guide device 10 to the proximal end 22b of the blood vessel catheter 22.

[0051] Referring to FIGS. 1B and 3, in use, the guide device 10 passes through the lumen of the blood vessel catheter 22 such that at least a portion of the tapered component 12 extends from the distal end 22b of the blood vessel catheter 22. In the schematic side views of FIGS. 1B and 3, the blood vessel catheter 22 is shown as translucent to aid understanding of the illustrated embodiment of the present invention. The illustrated length of the blood vessel catheter relative to the length of the tapered component is shortened in the figures to facilitate understanding of the embodiment. The term blood vessel catheter refers to any suitable catheter for use in a blood vessel (i.e., artery or vein). A guide wire (not shown) is passed through the tapered component 12 and the blood vessel catheter 22 such that the guide wire passes through the opening 13 of the tapered component 12, through the inner lumen 13a of the tapered component 12, and through the lumen of the blood vessel catheter 22. In such a configuration, the guide wire extends forward from the distal end 12b of the tapered component 12 and rearward from the proximal end (not shown) of the blood vessel catheter 22.

[0052] Behind the proximal end of the blood vessel catheter 22, the guide wire and the pushing means 14 extend side by side with each other. Thus, the axial movement of the pushing means 14 causes the axial movement of the tapered component 12 along the guide wire 20. During use, the guide wire can be disposed within the blood vessel so that it can guide the passage of the blood vessel catheter 22 while the proximal end of the blood vessel catheter 22 remains outside the blood vessel. When the tapered component 12 extends beyond the distal end 22b of the blood vessel catheter 22, the tapered component 12 guides the blood vessel catheter 22 within the blood vessel. Thus, the passage of the blood vessel catheter 22 within the blood vessel is facilitated by the tapered component 12, thereby substantially avoiding the "shaving effect" of the leading edge of the proximal end 22b of the catheter 22 in its interaction with the inner layer of the blood vessel. As a result, the risk that the blood vessel catheter 22 catches on the wall of the blood vessel, as well as the risk that the blood vessel goes into spasm, is reduced. As a result, patient comfort can be improved. These advantages can help increase the success rate of procedures (such as coronary angioplasty and percutaneous intervention (PCI)) in blood vessels such as the radial artery and the brachial artery (where problems related to the "shaving effect" are more widely recognized), and improve the feasibility across procedures in other blood vessels such as the femoral artery. In a preferred embodiment, the tapered component 12 is always partially within the blood vessel catheter 22 while the guide device 10 is guiding the passage of the blood vessel catheter 22 through the blood vessel. In a particular embodiment, the first portion 15 of the tapered component 12 may always be within the blood vessel catheter 22.

[0053] In particular, the pushing means 14 does not extend coaxially with the longitudinal axis 100, while the guide wire extends substantially along the longitudinal axis 100. As a result, the pushing means 14 does not interfere with the path of the guide wire 20. Importantly, the pushing means 14 is configured such that a portion of the guide wire that is radially adjacent to the pushing means 14 remains visible to the surgeon during use (i.e., when using the pushing means 14 to move the tapered component 12 along the guide wire 20). Thus, the surgeon can maintain the guide wire in view to ensure that the entire guide wire does not inadvertently advance into the blood vessel.

[0054] In the preferred embodiment shown in the figure, the pushing means 14 includes a wire having a rigidity that enables the tapered component 12 to advance within the blood vessel by pushing the wire. In an alternative embodiment, the pushing means 14 can take any alternative form that can advance the tapered component 12 and enables a portion of the guide wire that is radially adjacent to the pushing means 14 to remain visible to the surgeon during use. For example, the pushing means can include a rod. The wire or rod is only radially aligned with the guide wire over a small angular range and thus provides sufficient means to push (and pull) the tapered component 12 without significantly visually obscuring the exposed guide wire 20. Similarly, other preferred variations of the pushing means 14 can be radially aligned with the guide wire over a small angular range (e.g., less than 180°, less than 90°, less than 45°, less than 20°, less than 10°, or less than 5°). The pushing means 14 can be made of any suitable material having sufficient rigidity to facilitate the advancement of the tapered component 12 within the blood vessel by the operation of the pushing means 14. In a particular embodiment, the pushing means 14 can be made of metal (e.g., when the pushing means 14 is a wire or rod).

[0055] FIG. 4 shows a cross-section of an embodiment of the guide device 10 at the proximal end 12a of the tapered component 12. In the embodiment shown in FIG. 4, the distal end of the extrusion means 14 extends from the wall 12c. As described above, the wall 12c extends between the inner bore 13a of the tapered component 12 and the outer surface of the proximal end 12a. The thickness of the wall 12c is limited. For example, in a 6F size catheter, the tapered component has a maximum diameter of less than 1.7 mm, an inner bore diameter of about 1.1 mm, and thus provides a wall with a thickness of about 0.3 mm from which the extrusion means extends. In certain embodiments, the cross-section 40 of the extrusion means 14 is non-circular to facilitate connection of the extrusion means 14 to the tapered component 12. In certain embodiments, the non-circular cross-section 40 extends substantially across the length of the extrusion means 14. For example, the non-circular cross-section 40 may extend across more than 50%, 60%, 70%, 80%, or 90% of the length of the extrusion means 14. In alternative embodiments, the cross-section may vary along the length of the extrusion means 14. The non-circular cross-section 40 improves the attachment of the extrusion means 14 to the wall 12c with a limited thickness. The extrusion means 14 having the non-circular cross-section 40 has different bending characteristics along different axes of the cross-sectional profile. However, since the extrusion means 14 is long (relative to its width) and is constrained within the lumen of the guide catheter during use, the influence of the different bending characteristics of the extrusion means 14 on the control of the tapered component 12 is minimal and within an acceptable level. In certain embodiments, the non-circular cross-section 40 provides the extrusion means 14 with a special ease of extrusion while maintaining the flexibility and small cross-sectional profile of the extrusion means 14.

[0056] The extrusion means 14 can have any non-circular cross-section 40 suitable for attachment to the tapered component 12, the non-circular cross-section 40 being able to provide the rigidity and flexibility necessary to advance the tapered component 12 along the guide wire 20. The extrusion means 14 can also have a non-circular cross-section 40 that ensures that the guide wire remains visible during use. The cross-section 40 of the extrusion means 14 can comprise a plurality of sides. For example, the cross-section 40 can have four sides. One or more of the plurality of sides can be curved sides. One or more of the curved sides can be convex or concave curves. Further, the cross-section can have a convex curved side and a concave curved side. In a particular embodiment, the cross-section 40 can include, for example, a curved side that coincides with a part of the circumference of the inner bore 13a. Alternatively or additionally, the cross-section 40 can include a curved side that coincides with a part of the circumference of the outer surface of the proximal end 12a of the tapered component 12. The plurality of sides of the cross-section 40 can include adjacent sides having different lengths. In a particular embodiment, the cross-section 40 of the extrusion means 14 can have a first side having a length between 0.40 mm and 0.53 mm and a second side adjacent to the first side and having a length between 0.20 mm and 0.30 mm. In a particular embodiment, there can be a clearly defined angle between adjacent sides. Alternatively, the angle between adjacent sides of the profile can be rounded. The angle between pairs of adjacent sides can be 90°, greater than 90°, or less than 90°.

[0057] Figure 5 shows an example of the cross-sectional profile of the extrusion means 14 according to an embodiment of the present invention. However, the cross-section 40 of the extrusion means 14 is not limited to the embodiment shown in Figure 5. Further, in certain embodiments, the cross-section 40 of the extrusion means 14 may vary along the length of the extrusion means 14. The cross-section 40 of the extrusion means 14 may be substantially rectangular 140, 240, square 340, or annular arc 440, 740. In certain embodiments, the rectangle, square, or annular arc may have rounded corners 240, 440. The annular arcs 440, 740 may include curved sides 441, 741 that coincide with a portion of the circumference of the inner hole 13a of the tapered component 12. Additionally or alternatively, the annular arcs 40d, 40g may include curved sides 442, 742 that coincide with a portion of the circumference of the outer surface of the proximal end 12a of the tapered component 12. In certain embodiments, the cross-section 40 of the extrusion means 14 may be substantially elliptical or oval 640. In an alternative embodiment, the cross-section 40 of the extrusion means 14 may include a circular segment 840. The curved side 842 of the circular segment 840 may coincide with a portion of the circumference of the outer surface of the proximal end 12a of the tapered component 12. In certain embodiments, the cross-section 40 may be semi-circular. In certain embodiments, the cross-section 40 of the extrusion means 14 may be a rectangular-like shape 540, 940, 1040 having at least one curved side 542, 942, 1041. The curved sides 542, 942 may coincide with a portion of the circumference of the outer surface of the proximal end 12a of the tapered component 12. The curved side 1041 may coincide with a portion of the circumference of the inner hole 13a of the tapered component 12. In certain embodiments, the rectangular-like shape may include a first and a second side, and each first end of the first and second sides may be joined at a right angle to the opposite end of a third side. The third side may be longer than the first and second sides. The second ends of the first and second sides may be joined to the opposite end of a fourth side, where the fourth side is a curved side. The fourth side may be a convex or concave curve.

[0058] Using the extrusion means 14, the tapered component 12 is advanced into the blood vessel catheter 22. When the tapered component 12 extends beyond the distal end 22b of the blood vessel catheter 22, the connector 18 can removably connect the guide device 10 and the blood vessel catheter 22. FIGS. 6 and 7 show the connector 18 according to an embodiment of the present invention. By connecting the guide device 10 to the blood vessel catheter 22, over-insertion of the guide device 10 into the blood vessel catheter 22 can be prevented. In particular, the connection between the guide device 10 and the blood vessel catheter 22 will determine the maximum extent to which the tapered component 12 extends from the distal end 22b of the blood vessel catheter 22. Further, due to the connection between the guide device 10 and the blood vessel catheter 22, the guide device 10 and the blood vessel catheter move collectively (i.e., with minimal relative movement between them) as one along the guide wire 20.

[0059] In certain embodiments, the connector 18 can be disposed at or towards the proximal end 10a of the guide device 10. The connector 18 can be connected to the extrusion means 14 behind the proximal end 12a of the tapered component 12. In certain embodiments, the connector 18 can be movable along the extrusion means so as to be engageable with blood vessel catheters 22 of various lengths.

[0060] The connector 18 can removably connect the guide device 10 to the proximal end of the blood vessel catheter 22 by any suitable fixing mechanism including but not limited to push-fit and snap-fit arrangements. In certain embodiments, the connector can be rotatably connectable to the blood vessel catheter 22. In such embodiments, the connector 18 comprises a freewheel mechanism. The freewheel mechanism is configured to allow the connector 18 to be connected to the proximal end of the blood vessel catheter 22 without causing rotation of the extrusion means 14. Thus, when the connector 18 is rotated to connect to the blood vessel catheter 22, the tapered component 12 does not rotate within the blood vessel catheter 22 or within the blood vessel.

[0061] Figures 6 through 8 illustrate non-limiting embodiments of the connector 18 according to the present invention. Figures 6 and 7 show the connector 18 connected to the extrusion means 14 in an assembled state, while Figure 8 shows an exploded side view of the connector 18. The connector 18 includes a body 30, a lock tube 38, and a freewheel ring 24. When assembled, the body 30 and the freewheel ring 24 form a freewheel mechanism.

[0062] The body 30 includes a bore 34 that extends through the body 30 from a proximal end 30a to a distal end 30b. The central axis of the bore 34 coincides with the longitudinal axis 100 of the guide device 10. The body 30 has an annular rim 32. The rim 32 can be spaced proximally from the distal end 30b of the body 30. In an alternative embodiment, the rim can be at the distal end 30b of the body 30. The rim 32 can be continuous or can include a plurality of discrete raised sections. The body 30 includes a shoulder 38 spaced proximally from the rim 32. The shoulder 38 extends circumferentially around the body 30. The shoulder 38 can be continuous or can include a plurality of discrete raised sections. A channel 36 is formed between the rim 32 and the shoulder 38. The channel 38 is configured to receive a portion of the freewheel ring 24. In a particular embodiment, the proximal end 30a of the body 30 can include a thread 35 for connecting the body 30 to additional components. In a particular embodiment, the body 30 can be a single injection molding.

[0063] The freewheel ring 24 has an internal cavity 25 at its distal end. The internal cavity 25 has a thread 26 for connecting to the proximal end of the catheter 22. In certain embodiments, the internal cavity 25 may include a female luer thread. The freewheel ring 24 has an opening 27 at its proximal end. The opening extends through the proximal wall of the freewheel ring 24 into the internal cavity 25. The opening 27 is configured to receive the proximal end 30b of the body 30. The diameter of the opening 27 is configured to form a snap fit on the annular rim 32 and to be located between the annular rim 32 and the shoulder 38. The diameter of the opening 27 is smaller than the diameter of the rim 32 and the diameter of the shoulder 38.

[0064] During assembly of the connector 18, the proximal end 30b of the body 30 is inserted through the opening 27 of the freewheel ring 24. The opening 27 of the freewheel ring 24 is pressed onto the rim 32 such that the freewheel ring 24 is held within the channel 36. Thus, in the assembled state, the freewheel ring 24 is axially restricted relative to the body 30 by the rim 32 and the shoulder 38, but can rotate freely about the body 30. The axis of rotation of the freewheel ring 24 can be the longitudinal axis 100.

[0065] The extrusion means 14 is connected to the body 30 by a lock tube 28. The outer diameter of the lock tube 28 is smaller than the diameter of the hole 34 of the body 30. The inner diameter of the lock tube 28 is larger than the diameter of a guide wire (not shown).

[0066] During connection of the extrusion means 14 to the body 30, the extrusion means 14 is inserted into the hole 34 of the body 30. The lock tube 28 is also inserted into the hole 34 of the body 30 using an adhesive to firmly hold the lock tube 28 and the extrusion means 14 within the body 30. The lock tube 28 holds the extrusion means 14 in a position radially offset with respect to the longitudinal axis 100. This corresponds to the extrusion means 14 extending from the tapered component 12 at a position radially offset from the longitudinal axis 100.

[0067] Once the connector 18 is assembled and the pushing means 14 is connected to the body 30, the freewheel ring 24 can be rotated to connect the connector 18 to the proximal end of the blood vessel catheter 22. Since the freewheel ring 24 rotates relative to the body 30, the connection to the blood vessel catheter 22 does not rotate the pushing means 14. As a result, the tapered component 12 does not rotate within the blood vessel catheter 22 or within the blood vessel when the guide device 10 is connected to the catheter. Thus, the connector 18 provides a secure connection between the guide device 10 and the blood vessel catheter 22 while avoiding rotation of the tapered component 12.

[0068] Once the blood vessel catheter 22 has been advanced to the desired position within the blood vessel, the connector 18 can be disconnected from the blood vessel catheter 22, the pushing means 14 can be pulled rearward, and the guide device 10 can be withdrawn from the blood vessel along the guide wire 20, leaving the blood vessel catheter 22 in place. Advantageously, the guide device 10 can be used to reduce the risk of arterial spasm during a standard insertion procedure. This is in contrast to certain prior art methods where, in the presence of a restricted artery, a tortuous artery, or a spastic artery, the standard guide wire has to be removed and additional components inserted to continue the advancement of the catheter.

[0069] In addition to assisting in guiding the intravascular catheter 22 in front of the advancing catheter, the guide device 10 can be used to "rescue" a situation where snagging or spasm has occurred and the passage of the vascular catheter 22 along the guide wire within the blood vessel may be obstructed, and further advancement of the vascular catheter 22 may be inhibited or prevented. In such a situation, the guide device 10 can advance along the guide wire and through the lumen of the vascular catheter 22, such that the tapered component 12 projects from the distal end 22b of the vascular catheter 22. The tapered component 12 can then dilate the blood vessel to facilitate forward advancement of the vascular catheter 22 within the blood vessel and / or reduce the pain and discomfort experienced by the patient associated therewith. Further, the guide device according to certain embodiments of the present invention can be used as an introducer for a guide catheter, and the combination can be universal in that it can be used with catheters and guide wires from any manufacturer and can be used either through a sheath or without a sheath.

[0070] In certain preferred embodiments, the tapered component 12 can have a low-friction outer surface. The low-friction interface with the vessel wall facilitates smoother movement of the tapered component within the blood vessel. In certain embodiments, any lubricious and / or hydrophilic outer surface can provide such a low-friction outer surface. In certain embodiments, the hydrophilic outer surface can be provided by a hydrophilic coating applied to the tapered component 12. In alternative embodiments, the hydrophilic outer surface can be provided by the surface topography of the tapered component 12 (e.g., a plurality of grooves, indentations, or other surface features that can impart hydrophilic properties to the tapered component 12).

[0071] The tapered component 12 can be made of any suitable material. In certain embodiments, the tapered component 12 comprises a plastic material. Additionally or alternatively, the tapered component 12 can include an elastic material that can be deformable during use within a blood vessel. The tapered component 12 can be formed from a single material.

[0072] In certain embodiments, the tapered component 14 has an axial length of up to 30 cm. In certain embodiments, the tapered component 14 can have an axial length between 1 cm and 30 cm, or between 14 cm and 25 cm. In certain embodiments, the tapered component 14 has an axial length of about 14 cm. The tapered component 14 can have any axial length suitable for providing the necessary flexibility.

[0073] When the guide device 10 is used with a 6F catheter, the tapered component 12 can have an axial length of 14 cm, and has a cylindrical first section 15 with an axial length of 10 cm between the distal end 12b of the tapered component and the cylindrical first section 15 and an axial length of 4 cm. The second section 17 can be a convex cone where the taper of the cone coincides with an arc of a circle between a radius of 2000 mm and 4000 mm. Additionally or alternatively, the third section 19 can be a concave cone where the taper of the cone coincides with an arc of a circle between a radius of 2000 mm and 4000 mm.

[0074] In certain embodiments, the maximum diameter (e.g., in the uncompressed state) of the tapered component 12 is smaller than the inner diameter of the catheter into which it is inserted. The tapered component can have a maximum diameter of less than 3.00 mm, less than 2.7 mm, less than 2.29 mm, less than 2.0 mm, less than 1.7 mm, or less than 1.35 mm. For example, in the case of an 8F catheter, the maximum diameter can be less than 2.29 mm, in the case of a 7F catheter, the maximum diameter can be less than 2.0 mm, or in the case of a 6F catheter, the maximum diameter can be less than 1.7 mm. One of ordinary skill in the art will understand in this context that "F" refers to the French gauge system and that 1F corresponds to a diameter of 1.3 mm.

[0075] In order to be compatible with various guidewires 20, in certain embodiments, the apertures 13 and 29 can be sized to allow passage of a guidewire having a diameter between about 0.5 mm and 1 mm, such as 0.46 mm (0.018”), 0.64 mm (0.025”), 0.81 mm (0.032”), 0.89 mm (0.035”), 0.97 mm (0.038”), or 1.10 mm (0.043”). In certain non-limiting embodiments, the aperture 13 may be larger than 0.36 mm (0.014”) in order to allow a guidewire (e.g., an angioplasty wire) having a diameter of 0.36 mm (0.014”) to pass through the tapered component 12.

[0076] The guide device 10 is dimensionally compatible with various known vascular catheters 22 and / or guide wires 20 and may otherwise be suitable for use. A single-sized guide device 10 is preferably usable with various vascular catheters 22 of different lengths. To provide dimensional compatibility with a particular vascular catheter 22, when the tapered component 12 is in a position protruding from the distal end 22b of the vascular catheter 22, the extrusion means 14 must extend rearward beyond the proximal end of the vascular catheter 22. In certain embodiments, the extrusion means 14 can extend at least 60 cm, at least 70 cm, at least 80 cm, at least 90 cm, or at least 100 cm from the tapered component 12. In certain embodiments, the extrusion means 14 can be provided with one or more markers 16 (see FIG. 1) to indicate the deployed length of the guide device 10. For example, when a particular marker 16 is proximate to the proximal end of the catheter 22, the deployed length of the guide device 10 (and thus the vascular catheter 22) can be estimated from the marker 16. In certain non-limiting embodiments, the markers can include visual markers and / or non-visual markers such as radiopaque markers (e.g., tungsten or barium). In certain embodiments, one or more markers can be provided at any suitable location on the guide device 10, not limited to the extrusion means 14. A radiopaque marker approximately 2 mm from the distal tip can indicate the position of the distal end of the device under fluoroscopic screening.

[0077] The present invention is defined in the appended claims. To avoid misunderstanding, the present invention is not necessarily limited to the specific features and dimensions discussed above. Skilled readers will also understand that the features (and dimensions) discussed above are not exhaustive and that embodiments of the present invention having different features and / or dimensions can be realized.

[0078] Throughout the description and claims of this specification, the words "comprise" and "include" and their variations mean "include but not limited to", and they are not (and do not intend to) exclude other parts, additives, components, integers or steps. Throughout the description and claims of this specification, unless the context requires otherwise, the singular form includes the plural form. In particular, when an indefinite article is used, unless the context requires otherwise, this specification should be understood to consider not only the singular but also the plural. The term "component" is not limited to monolithic features and may be related to a multi-piece arrangement in certain embodiments.

[0079] Features, integers, characteristics, compounds, chemical moieties or groups described in connection with a particular aspect, embodiment or example of the invention are to be understood as applicable to any other aspect, embodiment or example described herein, unless incompatible therewith. All features (including all claims, abstract and drawings) disclosed herein, and / or all steps of any method or process so disclosed, may be combined in any combination, except combinations where at least some of such features and / or steps are mutually exclusive. The invention is not limited to the details of any of the foregoing embodiments. The invention extends to any novel one, or any novel combination, of the features disclosed herein (including all claims, abstract and drawings), or any novel one, or any novel combination, of the steps of any method or process so disclosed.

[0080] The reader's attention is directed to all papers and documents that are filed simultaneously with or before this specification in connection with this application and that are publicly available for public inspection in this specification, and the content of all such papers and documents is incorporated herein by reference. Regarding the technical idea grasped from the above embodiments, its aspects are shown below. [Aspect 1] A guide device for a vascular catheter inserted onto a guide wire, the guide device comprising: A tapered component that passes through the hole of the vascular catheter and extends from its distal end, The tapered component having an opening through which the guide wire can pass so that the tapered component can move along the guide wire, and Pushing means extending from the tapered component and configured to extend beyond the proximal end of the vascular catheter, Including, The tapered component includes a first section, a second section, and a third section, the first section being disposed between the proximal end of the tapered component and the second section, the second section being disposed between the first section and the third section, and the third section being disposed between the second section and the distal end of the tapered component, The first section is cylindrical, the second section and the third section are conical, and the taper of the second section is different from the taper of the third section, a guide device. [Aspect 2] The guide device according to Aspect 1, wherein the second section is a convex conical section. [Aspect 3] The guide device according to Aspect 1 or 2, wherein the third section is a concave conical section. [Aspect 4] The guide device according to any one of Aspects 1 to 3, wherein the proximal end of the first section coincides with the proximal end of the tapered component, and optionally, the diameter of the first section is the maximum diameter of the tapered component. [Aspect 5] The guide device according to any one of Aspects 1 to 4, wherein the distal end of the third section coincides with the distal end of the tapered component, and optionally, the minimum diameter of the tapered component coincides with the distal end of the third section. [Aspect 6] The guide device according to any one of Aspects 1 to 5, wherein the movement of the tapered component along the guide wire can be controlled in the proximal direction beyond the proximal end of the vascular catheter by the movement of the pushing means. [Aspect 7] The guide device according to aspect 6, comprising a connector connectable to the pushing means for removably connecting the guide device to the proximal end of the blood vessel catheter. [Aspect 8] The guide device according to aspect 7, wherein the connector comprises a freewheel mechanism configured to enable the connector to be connected to the proximal end of the blood vessel catheter without rotating the pushing means. [Aspect 9] The guide device according to aspect 8, wherein the connector comprises a body connectable to the pushing means and a freewheel ring for connecting to the catheter. [Aspect 10] The guide device according to aspect 9, wherein the freewheel ring is axially restricted with respect to the body of the connector and can rotate freely around the body of the connector. [Aspect 11] The guide device according to aspect 10, including a rim for restricting the freewheel ring in the distal direction with respect to the body of the connector. [Aspect 12] The guide device according to any one of aspects 7 to 11, wherein the connector is movable along the pushing means. [Aspect 13] The guide device according to any one of aspects 6 to 12, wherein the pushing means has a non-circular cross section. [Aspect 14] The guide device according to aspect 13, wherein the cross section of the pushing means has a plurality of sides, and optionally, the cross section of the pushing means has four sides. [Aspect 15] The guide device according to aspect 14, wherein adjacent sides have different lengths. [Aspect 16] The guide device according to aspect 14 or 15, wherein the angle between adjacent sides is rounded. [Aspect 17] The guide device according to any one of aspects 14 to 16, wherein the plurality of sides includes a first curved side. [Aspect 18] The guide device according to aspect 17, wherein the first curved side coincides with a part of the circumference of the outer surface of the proximal end of the tapered component. [Aspect 19] The guide device according to any one of aspects 1 to 18, comprising a bore accessible through the opening. [Aspect 20] The guide device according to aspect 19 when dependent on aspect 14, wherein the plurality of sides includes a second curved side that coincides with a part of the circumference of the bore of the tapered component. [Aspect 21] A guide device for a blood vessel catheter inserted on a guide wire, the guide device comprising A tapered component that passes through the holes of the vascular catheter and extends from its distal end, the tapered component having an opening through which the guide wire can pass so that the tapered component can move along the guide wire. Extrusion means having a non-circular cross-section, extending from the tapered component, and configured to extend beyond the proximal end of the vascular catheter. Including A guide device, wherein the movement of the tapered component along the guide wire can be controlled beyond the proximal end of the vascular catheter by the movement of the extrusion means. [Aspect 22] The guide device according to aspect 21, wherein the cross-section of the extrusion means has a plurality of sides, and optionally, the cross-section of the extrusion means has four sides. [Aspect 23] The guide device according to aspect 22, wherein adjacent sides have different lengths. [Aspect 24] The guide device according to aspect 22 or 23, wherein the angle between adjacent sides is rounded. [Aspect 25] The guide device according to any one of aspects 22 to 24, wherein the plurality of sides includes a first curved side. [Aspect 26] The guide device according to aspect 25, wherein the first curved side coincides with a part of the circumference of the outer surface of the proximal end of the tapered component. [Aspect 27] The guide device according to any one of aspects 21 to 26, comprising a bore accessible through the opening. [Aspect 28] The guide device according to aspect 27 when dependent on aspect 22, wherein the plurality of sides includes a second curved side that coincides with a part of the circumference of the bore of the tapered component. [Aspect 29] The guide device according to any one of aspects 21 to 28, comprising a connector connectable to the extrusion means for removably connecting the guide device to the proximal end of the vascular catheter. [Aspect 30] The guide device according to aspect 29, wherein the connector comprises a freewheel mechanism configured to enable the connector to be connected to the proximal end of the vascular catheter without rotating the extrusion means. [Aspect 31] The guide device according to aspect 30, wherein the connector comprises a body connectable to the extrusion means and a freewheel ring for connecting to the catheter. [Aspect 32] The freewheel ring is axially restricted with respect to the body of the connector and can rotate freely around the body of the connector, the guide device according to aspect 31. [Aspect 33] The guide device according to aspect 32, including a rim for restricting the freewheel ring in the distal direction with respect to the body of the connector. [Aspect 34] The guide device according to any one of aspects 29 to 33, wherein the connector is movable along the pushing means. [Aspect 35] A guide device for a blood vessel catheter inserted onto a guide wire, the guide device comprising A tapered component passing through the hole of the blood vessel catheter and extending from its distal end, the tapered component having an opening through which the guide wire can pass so that the tapered component can move along the guide wire, the tapered component; Pushing means extending from the tapered component and configured to extend beyond the proximal end of the blood vessel catheter; A connector for removably connecting the guide device to the proximal end of the blood vessel catheter; Including The connector is connectable to the pushing means and is provided with a freewheel mechanism configured to enable the connector to be connected to the proximal end of the blood vessel catheter without rotating the pushing means. The movement of the tapered component along the guide wire can be controlled beyond the proximal end of the blood vessel catheter by the movement of the pushing means, the guide device. [Aspect 36] The guide device according to aspect 35, wherein the connector comprises a body connectable to the pushing means and a freewheel ring for connecting to the catheter. [Aspect 37] The freewheel ring is axially restricted with respect to the body of the connector and can rotate freely around the body of the connector, the guide device according to aspect 36. [Aspect 38] The guide device according to aspect 37, including a rim for restricting the freewheel ring in the distal direction with respect to the body of the connector. [Aspect 39] The guide device according to any one of aspects 35 to 38, wherein the connector is movable along the pushing means. [Aspect 40] The guide device according to any one of aspects 35 to 39, wherein the extrusion means has a non-circular cross-section. [Aspect 41] The guide device according to aspect 40, wherein the cross-section of the extrusion means has a plurality of sides, and optionally, the cross-section of the extrusion means has four sides. [Aspect 42] The guide device according to aspect 41, wherein adjacent sides have different lengths. [Aspect 43] The guide device according to aspect 41 or 42, wherein the angle between adjacent sides is rounded. [Aspect 44] The guide device according to any one of aspects 41 to 43, wherein the plurality of sides includes a first curved side. [Aspect 45] The guide device according to aspect 44, wherein the first curved side coincides with a part of the circumference of the outer surface of the proximal end of the tapered component. [Aspect 46] The guide device according to any one of aspects 35 to 45, comprising an inner hole accessible through the opening. [Aspect 47] The guide device according to aspect 46 when dependent on aspect 41, wherein the plurality of sides includes a second curved side that coincides with a part of the circumference of the inner hole of the tapered component. [Aspect 48] The tapered component includes a first section, a second section, and a third section. The first section is disposed between the proximal end of the tapered component and the second section. The second section is disposed between the first section and the third section. The third section is disposed between the second section and the distal end of the tapered component. The guide device according to any one of aspects 21 to 47, wherein the first section is cylindrical, the second section and the third section are conical, and the taper of the second section is different from the taper of the third section. [Aspect 49] The guide device according to aspect 48, wherein the second section is a convex conical section. [Aspect 50] The guide device according to aspect 48 or 49, wherein the third section is a concave conical section. [Aspect 51] The guide device according to any one of aspects 48 to 50, wherein the proximal end of the first section coincides with the proximal end of the tapered component, and optionally, the diameter of the first section is the maximum diameter of the tapered component. [Aspect 52] The guide device according to any one of aspects 48 to 51, wherein the distal end of the third section coincides with the distal end of the tapered component, and optionally, the minimum diameter of the tapered component coincides with the distal end of the third section. [Aspect 53] The guide device according to any one of aspects 1 to 52, wherein the pushing means is arranged to allow a part of the guide wire that is radially adjacent to the pushing means to remain visible to the surgeon during use. [Aspect 54] A kit comprising: the guide device according to any one of aspects 1 to 53; a vascular catheter; and wherein the tapered component of the guide device is configured to pass through the lumen of the vascular catheter and extend from its distal end. [Aspect 55] A kit comprising: the guide device according to any one of aspects 1 to 53; a guide wire; and wherein the opening of the tapered component may allow passage of the guide wire therethrough such that the tapered component can move along the guide wire.

Claims

1. A guide device for a blood vessel catheter inserted onto a guide wire, the guide device comprising: A tapered component that passes through a hole of the blood vessel catheter and extends from a distal end thereof, the tapered component having an opening through which the guide wire can pass so that the tapered component can move along the guide wire; Extrusion means extending from the tapered component and configured to extend beyond a proximal end of the blood vessel catheter; Including; The tapered component includes a first section, a second section, and a third section. The first section is disposed between the proximal end of the tapered component and the second section. The second section is disposed between the first section and the third section. The third section is disposed between the second section and the distal end of the tapered component. The first section is cylindrical, the second section and the third section are conical, and the taper of the second section is different from the taper of the third section. A guide device.

2. The guide device according to claim 1, wherein the second section is a convex conical section.

3. The guide device according to claim 1, wherein the third section is a concave conical section.

4. The guide device according to claim 1, wherein a proximal end of the first section coincides with the proximal end of the tapered component, and optionally, a diameter of the first section is a maximum diameter of the tapered component.

5. The guide device according to claim 1, wherein a distal end of the third section coincides with the distal end of the tapered component, and optionally, a minimum diameter of the tapered component coincides with the distal end of the third section.

6. The guide device according to claim 1, wherein the movement of the tapered component along the guide wire can be controlled in a proximal direction beyond the proximal end of the blood vessel catheter by the movement of the extrusion means.

7. The guide device according to claim 6, comprising a connector connectable to the extrusion means for removably connecting the guide device to the proximal end of the blood vessel catheter.

8. The guide device according to claim 7, wherein the connector includes a freewheel mechanism configured to enable connecting the connector to the proximal end of the blood vessel catheter without rotating the pushing means.

9. The guide device according to claim 8, wherein the connector includes a main body connectable to the pushing means and a freewheel ring for connecting to the catheter.

10. The guide device according to claim 9, wherein the freewheel ring is axially restricted with respect to the main body of the connector and can rotate freely around the main body of the connector.

11. The guide device according to claim 10, including a rim for restricting the freewheel ring in a distal direction with respect to the main body of the connector.

12. The guide device according to claim 7, wherein the connector is movable along the pushing means.

13. The guide device according to claim 6, wherein the pushing means has a non-circular cross-section.

14. The guide device according to claim 13, wherein the cross-section of the pushing means has a plurality of sides, and optionally, the cross-section of the pushing means has four sides.

15. The guide device according to claim 14, satisfying at least one of the following: adjacent sides among the plurality of sides have different lengths; the angle between adjacent sides among the plurality of sides is rounded; and the plurality of sides includes a first curved side.

16. The guide device according to claim 14, wherein the plurality of sides includes a first curved side, and the first curved side coincides with a part of the circumference of the outer surface of the proximal end of the tapered component.

17. The guide device according to claim 1, comprising a bore accessible through the opening.

18. The guide device according to claim 17, wherein the cross-section of the pushing means has a plurality of sides including a second curved side that coincides with a part of the circumference of the bore of the tapered component.

19. A guide device for a blood vessel catheter inserted on a guide wire, wherein the guide device A tapered component that passes through the holes of the blood vessel catheter and extends from its distal end, the tapered component having an opening through which the guide wire can pass so that the tapered component can move along the guide wire. Extrusion means extending from the tapered component and configured to extend beyond the proximal end of the blood vessel catheter. A connector for removably connecting the guide device to the proximal end of the blood vessel catheter. Comprising The connector is connectable to the extrusion means and is provided with a freewheel mechanism configured to enable the connector to be connected to the proximal end of the blood vessel catheter without rotating the extrusion means. A guide device, wherein the movement of the tapered component along the guide wire can be controlled beyond the proximal end of the blood vessel catheter by the movement of the extrusion means.

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