Guide device for vascular catheters

Abstract

A guide device for a vascular catheter into which a guide wire is inserted. The guide device comprises a tapered component that passes through the bore of the vascular catheter and extends at the distal end of the vascular catheter. To allow the tapered component to move along the guide wire, the tapered component is provided with a hole through which the guide wire can pass. A pushing means extends from the tapered component and extends beyond the proximal end of the vascular catheter. The tapered component comprises a first section, a second section, and a third section. The first section is positioned between the proximal end of the tapered component and the second section, the second section is positioned between the first section and the third section, and the third section is positioned between the second section and the distal end of the tapered component. The first section is a cylinder, and the second and third sections are conical. The taper of the second section is different from the taper of the third section.

Description

Technology Field

[0001] The present invention relates to a guide device for a vascular catheter, and more particularly to a guide device capable of facilitating the passage of a catheter through a blood vessel. Background Technology

[0002] Arterial disease is currently a leading cause of death in the UK and globally. Arterial disease is caused by stenosis resulting from the accumulation of fatty deposits (atherosclerosis). Coronary arteries run along the surface of the heart and supply blood to the heart muscle. For example, stenosis associated with coronary heart disease can restrict blood flow and block the supply of essential oxygen to the heart muscle. To access coronary arteries and other arteries, doctors must insert a catheter into the vascular system. Traditionally, catheters were inserted through the femoral artery for the most common vascular interventions to access the coronary arteries. Recently, the radial artery has become more frequently used. The most common procedure to treat coronary heart disease is called coronary angioplasty or percutaneous coronary intervention (PCI) (commonly known as 'stent insertion').

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

[0004] Catheters are used to deliver angioplasty devices, including wires, balloons, and stents, as well as contrast agents. Due to technical requirements for vascular catheters, they are often made of relatively rigid materials and formed into cylindrical tubes. When a vascular catheter is advanced through an artery in the arm, the so-called "razor effect" often occurs, where the edge of the catheter scrapes against the artery wall. This is painful for the patient, can cause arterial spasms, and can lead to entanglement and serious bleeding complications.

[0005] If spasms or obstruction occur, the patient is given a combination of sedatives, analgesics (e.g., opioids), and arteriodilators, which frequently delays the procedure. In some situations, the procedure must be performed through a different artery or stopped altogether. Performing the procedure through the femoral artery carries an additional risk of bleeding and major complications. The problem to be solved

[0006] While prior art offers several solutions that help reduce the risk of some of these problems occurring, these solutions often require expensive devices. Furthermore, since many prior art solutions are not compatible with standard equipment and are compatible only with specific catheter hardware, multiple devices are required to select the appropriate device for use with a particular catheter.

[0007] The purpose of some embodiments of the present invention is to overcome at least some disadvantages associated with the prior art. means of solving the problem

[0008] According to a first aspect of the present invention, a guide device for a vascular catheter into which a guide wire is inserted is provided, said guide device comprising a tapered component that passes through the bore of said vascular catheter and extends from the distal end of said vascular catheter;

[0009] It includes a pushing means that extends from the above-mentioned tapered component and extends beyond the proximal end of the vascular catheter,

[0010] In order for the tapered component to move along the guide wire, the tapered component is provided with a hole through which the guide wire can pass, and

[0011] The above-described tapered component comprises a first section, a second section, and a third section, wherein 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.

[0012] The first section is a cylinder, and the second and third sections are conical, and the taper of the second section is different from the taper of the third section.

[0013] In some embodiments, the second section may be a convex cone section. The third section may be a concave cone section. In some embodiments, the proximal end of the first section may 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 some embodiments, the distal end of the third section may coincide with the distal end of the tapered component. The minimum diameter of the tapered component may coincide with the distal end of the third section.

[0014] The movement of the tapered component along the guide wire can be controlled in a proximal direction from beyond the proximal end of the vascular catheter by the movement of the pushing means.

[0015] The guide device may include a connector connectable to the pushing means to detachably connect the guide device to the proximal end of the vascular catheter. The connector may include a free-wheel mechanism configured to allow connection of the connector to the proximal end of the vascular catheter without rotating the pushing means. In some embodiments, the connector may include a body connectable to the pushing means and a free-wheel ring for connecting to the catheter. The free-wheel ring may be restricted from axial movement relative to the body of the connector and may rotate freely around the body of the connector. A rim may restrict the movement of the free-wheel ring distally relative to the body of the connector. The connector may move along the pushing means.

[0016] In some embodiments, the pushing means may have a non-circular cross-section. The cross-section of the pushing means may have multiple sides. The cross-section of the pushing means may have four sides. The lengths of adjacent sides may differ. The corners between adjacent sides may be rounded. In some embodiments, the multiple sides may include a first curved side. The first curved side may correspond to a portion of the circumference of the outer surface of the proximal end of the tapered component.

[0017] In some embodiments, the guide device may include an internal bore accessible through the hole. The plurality of sides of the pushing means may include a second curved side that corresponds to a portion of the circumference of the internal bore of the tapered component.

[0018] In some embodiments, the pushing means may be arranged so that a portion of the guide wire radially adjacent to the pushing means remains visible to the operator during use.

[0019] According to a second aspect of the present invention, a guide device for a vascular catheter into which a guide wire is inserted is provided, and said guide device:

[0020] A tapered component passing through the bore of a vascular catheter and extending from the distal end of the vascular catheter;

[0021] It includes a pushing means having a non-circular cross-section and configured to extend from the tapered component and extend beyond the proximal end of the vascular catheter,

[0022] In order for the tapered component to move along the guide wire, the tapered component is provided with a hole through which the guide wire can pass, and

[0023] The movement of the tapered component along the guide wire can be controlled from beyond the proximal end of the vascular catheter by the movement of the pushing means.

[0024] In some embodiments, the pushing means may have a non-circular cross-section. The cross-section of the pushing means may have multiple sides. The cross-section of the pushing means may have four sides. The lengths of adjacent sides may differ. The corners between adjacent sides may be rounded. In some embodiments, the multiple sides may include a first curved side. The first curved side may correspond to a portion of the circumference of the outer surface of the proximal end of the tapered component.

[0025] In some embodiments, the guide device may include an internal bore accessible through the hole. The plurality of sides of the pushing means may include a second curved side that corresponds to a portion of the circumference of the internal bore of the tapered component.

[0026] The guide device may include a connector connectable to the pushing means to detachably connect the guide device to the proximal end of the vascular catheter. In some embodiments, the connector may include a free-wheel mechanism configured to allow connection of the connector to the proximal end of the vascular catheter without rotating the pushing means. In some embodiments, the connector may include a body connectable to the pushing means and a free-wheel ring for connecting to the catheter. The free-wheel ring may move axially relative to the body of the connector and may rotate freely around the body of the connector. A rim may restrict the movement of the free-wheel ring distally relative to the body of the connector. The connector may move along the pushing means.

[0027] In some embodiments, the tapered component may include a first section, a second section, and a third section. The first section may be positioned between the proximal end of the tapered component and the second section. The second section may be positioned between the first section and the third section. The third section may be positioned between the second section and the distal end of the tapered component. The first section may be a cylinder. The second and third sections may be conical, and the taper of the second section is different from the taper of the third section.

[0028] In some embodiments, the second section may be a convex cone section. The third section may be a concave cone section. In some embodiments, the proximal end of the first section may 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 some embodiments, the distal end of the third section may coincide with the distal end of the tapered component. The minimum diameter of the tapered component may coincide with the distal end of the third section.

[0029] In some embodiments, the pushing means may be arranged so that a portion of the guide wire radially adjacent to the pushing means remains visible to the operator during use.

[0030] According to a third aspect of the present invention, a guide device for a vascular catheter into which a guide wire is inserted is provided, and said guide device:

[0031] A tapered component passing through the bore of a vascular catheter and extending from the distal end of the vascular catheter;

[0032] Pushing means configured to extend from the above-mentioned tapered component and extend beyond the proximal end of the vascular catheter; and

[0033] The above guide device includes a connector for detachably connecting to the proximal end of a vascular catheter, and

[0034] The above-described tapered component is provided with a hole through which the guide wire can pass so as to move along the guide wire, and

[0035] The above connector can be connected to the above pushing means, and

[0036] The connector includes a free rotation mechanism configured to allow connection of the connector to the proximal end of the vascular catheter without rotating the pushing means, and

[0037] The movement of the tapered component along the guide wire can be controlled from beyond the proximal end of the vascular catheter by the movement of the pushing means.

[0038] In some embodiments, the connector may include a body connectable to the pushing means and a free-rotating ring for connecting to the catheter. The free-rotating ring may be restricted from axial movement relative to the body of the connector and may rotate freely around the body of the connector. A rim may restrict the movement of the free-rotating ring distally relative to the body of the connector. The connector may move along the pushing means.

[0039] In some embodiments, the pushing means may have a non-circular cross-section. The cross-section of the pushing means may have multiple sides. The cross-section of the pushing means may have four sides. The lengths of adjacent sides may differ. The corners between adjacent sides may be rounded. In some embodiments, the multiple sides may include a first curved side. The first curved side may correspond to a portion of the circumference of the outer surface of the proximal end of the tapered component.

[0040] In some embodiments, the guide device may include an internal bore accessible through the hole. The plurality of sides of the pushing means may include a second curved side that corresponds to a portion of the circumference of the internal bore of the tapered component.

[0041] In some embodiments, the tapered component may include a first section, a second section, and a third section. The first section may be positioned between the proximal end of the tapered component and the second section. The second section may be positioned between the first section and the third section. The third section may be positioned between the second section and the distal end of the tapered component. The first section may be a cylinder. The second and third sections may be conical, and the taper of the second section is different from the taper of the third section.

[0042] In some embodiments, the second section may be a convex cone section. The third section may be a concave cone section. In some embodiments, the proximal end of the first section may 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 some embodiments, the distal end of the third section may coincide with the distal end of the tapered component. The minimum diameter of the tapered component may coincide with the distal end of the third section.

[0043] In some embodiments, the pushing means may be arranged so that a portion of the guide wire radially adjacent to the pushing means remains visible to the operator during use.

[0044] In any one of the first, second, and third embodiments of the present invention, the tapered component may have a low-friction outer surface. In some embodiments, the low-friction outer surface may include a hydrophilic outer surface.

[0045] In some embodiments, the pushing means may include a wire extending from the tapered component.

[0046] In some embodiments, the tapered component may have an axial length of 10 cm to 30 cm, and optionally 14 cm to 25 cm. In some embodiments, the tapered component may have an axial length of about 20 cm.

[0047] The pushing means may 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.

[0048] In some embodiments, the hole may be sized to allow the passage of 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").

[0049] The tapered component may 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 some embodiments, the maximum outer diameter may coincide with the proximal end of the tapered component, and the tapered component may be tapered from the minimum outer diameter at the distal end of the tapered component to the maximum outer diameter.

[0050] The guide device may further comprise a radiopaque material. In some embodiments, the tapered component may comprise a radiopaque material. In non-limiting embodiments, the radiopaque material may be barium sulfate. In some embodiments, the guide device may further comprise one or more markers. The one or more markers may include one or more radiopaque markers for indicating the location of a portion of the guide device under fluoroscopic screening. The one or more radiopaque markers may be placed on the tapered component. In alternative embodiments, the one or more markers may be provided on the pushing means, for example, to indicate the extended length of the guide device. In some embodiments, the guide means may comprise ink or a physical band that makes the distal end of the tapered component visible to X-ray and other medical imaging technologies.

[0051] In some embodiments, the tapered component may include a plastic material.

[0052] In some embodiments, the pushing means may include metal and / or plastic materials.

[0053] According to another aspect of the present invention, a kit is provided, said kit being:

[0054] The guidance device as described above; and

[0055] Vascular catheter;

[0056] Includes,

[0057] The tapered component of the above-described guide device is configured to pass through the bore of the vascular catheter and extend from the distal end of the vascular catheter.

[0058] The above kit may additionally include a guide wire, and the hole of the tapered component may allow a passage through which the guide wire passes so that the tapered component can move along the guide wire.

[0059] According to another aspect of the present invention, a kit is provided, said kit being:

[0060] A guide device as described above;

[0061] Guide wire;

[0062] Includes,

[0063] The hole of the above-mentioned tapered component may allow a passage for the guide wire to pass through so that the tapered component can move along the guide wire. Brief explanation of the drawing

[0064] Embodiments of the present invention are further described below with reference to the accompanying drawings, wherein: FIG. 1a is a schematic side view of a guide device according to an embodiment of the present invention; FIG. 1b is a schematic side view of a guide device according to an embodiment of the present invention used with a catheter; FIG. 2 is a schematic side view of a part of a guide device according to an embodiment of the present invention; FIG. 3 is a schematic side view of a part of a guide device according to an embodiment of the present invention used with a catheter and a guide wire; FIG. 4 is a schematic cross-sectional view of a guide device according to one embodiment of the present invention; FIG. 5 is a schematic cross-sectional view of a pushing means of a guide device according to an embodiment of the present invention; FIG. 6 is a schematic cross-sectional view of the distal end of a connector for a guide device according to one embodiment of the present invention; FIG. 7 is a schematic side view of a connector for a guide device according to one embodiment of the present invention; and FIG. 8 is a schematic exploded side view of a connector for a guide device according to one embodiment of the present invention. Specific details for implementing the invention

[0065] FIGS. 1A and FIGS. 1B illustrate schematic side views of a guide device (10) according to an embodiment of the present invention. The guide device (10) can facilitate improved passage of a vascular catheter through a peripheral blood vessel (e.g., radial artery).

[0066] The guide device (10) extends along the longitudinal axis (100) between the proximal end (10a) and the distal end (10b). Throughout this specification, references to an anterior or distal direction (and similar direction) refer to a direction toward the distal end (10b) (or away from the proximal end (10a)) parallel to the longitudinal axis (100). Similarly, references to a posterior or proximal direction (or similar direction) refer to a direction toward the proximal end (10a) (or away from the distal end (10b)) parallel to the longitudinal axis (100). References to an axial direction, etc. refer to a direction parallel to the longitudinal axis (100). References to the radial direction, etc., relate to a direction extending perpendicularly to the longitudinal axis (100), where the radially outer position is further from the longitudinal axis (100) than the radially inner position. References to the circumferential direction, etc., relate to a path along the circumference (partially or entirely) of a conceptual circle where the surface extends perpendicularly to the longitudinal axis (100). References to the cross-section relate to a cross-section of a plane perpendicular to the longitudinal axis (100).

[0067] The guide device (10) includes a tapered component (12) that generally extends along the longitudinal axis (100) from a proximal end (10a) to a distal end (10b). In a non-limiting embodiment illustrated in the drawing, 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 a minimum diameter at the distal end (12b) to a maximum diameter at the rear of the distal end (12b). In some embodiments, the maximum diameter may coincide with the proximal end (12a) of the tapered component (12).

[0068] In some embodiments, the shape of the taper changes along the tapered component (12) between the proximal end (12a) and the distal end (12b). In the embodiment illustrated in FIG. 2, the tapered component (12) comprises a first section (15), a second section (17), and a third section (19). Each section has a different shape. However, the entire outer profile of the tapered component (12) is continuous along a direction parallel to the longitudinal axis (100). The first section (15) is positioned between the proximal end (12a) and the second section (17) of the tapered component (12). In the embodiment illustrated in FIG. 2, the first section (15) takes the form of a cylinder. 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 some embodiments, the diameter of the first section (15) may be the maximum diameter of the tapered component (12). The second section (17) is positioned between the first section (15) and the third section (19). In the embodiment illustrated in FIG. 2, the second section (17) has a convex cone shape. That is, the tapered profile of the cone follows a convex curve. The diameter of the cross-section of the convex cone decreases at an increasing rate. 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 some embodiments, the diameter of the proximal end of the second section (17) may be the same as the diameter of the first section (15). The third section (19) is positioned between the second section (17) and the distal end (12b) of the tapered component (12). In the embodiment illustrated in FIG. 2, the third section (19) has the shape of a concave cone. That is, the taper profile of the cone follows a concave curve. The cross-sectional diameter of the concave cone decreases at a decreasing rate. 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 some embodiments, the diameter of the proximal end of the third section (19) may be the same as the diameter of the distal end of the second section (17). The distal end of the third section (19) may correspond to the distal end (12a) of the tapered component (12). In some embodiments, the minimum diameter of the tapered component (12) may be the diameter of the distal end of the third section (19). The aforementioned shape of the tapered component (12) provides improved flexibility compared to the prior art, allowing for effective navigation of blood vessels. As a result, in some embodiments, the tapered component (12) may be manufactured without the need to change the material or material properties (e.g., hardness) along its length.

[0069] In other embodiments, the tapered component may take any alternative shape capable of providing the required flexibility. In alternative embodiments, the tapered component may include a different number of sections. For example, a fourth section may extend distally from the third section. The fourth section (not shown) may take the form of a cylinder. Additionally, or alternatively, a fifth section may extend proximally from the first section. The fifth section (not shown) may take the form of a cylinder. In some embodiments, additional sections may be placed between the first section (15) and the second section (17) and / or between the second section (17) and the third section (19). Additionally, the shape of each section may take a different form. The second section (17) may take the form of a cone (i.e., the tapered profile of the cone follows a straight line). Alternatively, the second section (17) may take the shape of a concave cone, or the second section (17) may have a radius or parabolic taper. The third section (19) may take the shape of a cone (i.e., the taper profile of the cone follows a straight line). Alternatively, the third section (19) may take the shape of a convex cone, or the third section (19) may have a radius or parabolic taper. In some embodiments, the taper of the second section (17) may differ from the taper of the third section (19). For example, the taper of the second section (17) is relatively (at least partially) steeper with respect to the longitudinal axis (100) than the taper of the third section (19).

[0070] The tapered component (12) includes an aperture (13) at its distal end (12b). The tapered component (12) is hollow so that the inner bore (13a) of the tapered component (12) is accessible through the aperture (13). The inner bore (13a) of the tapered component (12) also extends toward the proximal end (12a) of the tapered component (12) so that it is 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) of the tapered component (12) to the distal end (12b). The inner bore (13a) is accessible through the second hole (13b) at the proximal end (12a) of the tapered component (12). A wall (12c) extends between the outer surface of the proximal end (12a) of the tapered component (12) and the inner bore (13a). In some embodiments, at least a portion of the wall (12c) is 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) may provide a tapered opening for the second hole (13b).

[0071] The guide device (10) also includes a pushing means (14) (e.g., a pushing component or a pushing article in the form of an assembly of pushing components) that extends rearward from the tapered component (12). The pushing means (14) may extend further from a position on the tapered component (12) that is axially anterior to the proximal end (12a) of the tapered component (12). The pushing means (14) may be inserted into a groove of the tapered component (12). When the pushing means (14) extends proximally from the tapered component (12) out of the blood vessel (and body), the pushing means (14) is rigid enough to move the tapered component (12) forward and backward through the blood vessel. Despite this rigidity, the pushing means (14) is also flexible enough to bend along the contour of the blood vessel as it passes through it.

[0072] The guide device (10) further includes a connector (18) connected to a pushing means (14). The connector (18) can facilitate easier handling and movement of the pushing means (14) from outside the blood vessel. The connector (18) may be configured to detachably connect the guide device (10) to the distal end (22b) of a vascular catheter (22).

[0073] Referring to FIGS. 1b and FIGS. 3, the guide device (10) passes through the bore of the vascular catheter (22) so that, in use, at least a portion of the tapered component (12) extends from the distal end (22b) of the vascular catheter (22). In the schematic side views of FIGS. 1b and FIGS. 3, the vascular catheter (22) is depicted in translucent form to aid in understanding the illustrated embodiment of the invention. The illustrated length of the vascular catheter relative to the length of the tapered component is shortened in the drawings to facilitate understanding of the embodiment. The term vascular catheter refers to any catheter suitable for use in a blood vessel (i.e., an artery or a vein). The tapered component (12) and the vascular catheter (22) are threaded with respect to the guide wire (not shown) so that the guide wire passes through the hole (13) of the tapered component (12), the inner bore (13a) of the tapered component (12), and the bore of the vascular catheter (22). In this configuration, the guide wire extends forward from the distal end (12b) of the tapered component (12) and backward from the proximal end (not shown) of the vascular catheter (22).

[0074] The guide wire and the pushing means (14) extend parallel to the rear of the proximal end of the vascular catheter (22). Thus, the axial movement of the pushing means (14) causes the axial movement of the tapered component (12) along the guide wire (20). In use, the guide wire may be positioned inside the blood vessel to guide the passage of the vascular catheter (22) while the proximal end of the vascular catheter (22) remains outside the blood vessel. Given that the tapered component (12) extends beyond the distal end (22b) of the vascular catheter (22), the tapered component (12) guides the vascular catheter (22) inside the blood vessel. Thus, the passage of the vascular catheter (22) inside the blood vessel is made easier by the tapered component (12), thereby substantially avoiding the "razor effect" caused by the interaction of the anterior edge of the catheter (22) with the inner wall of the blood vessel. Therefore, the risk of the vascular catheter (22) getting stuck in the blood vessel wall is reduced, and the risk of the blood vessel spasming is also reduced. As a result, patient comfort may be improved. These benefits may help increase the success rate of procedures (such as coronary angioplasty or percutaneous intervention (PCI)) in blood vessels such as the radial and brachial arteries (where problems related to the "razor effect" are more prevalent) and improve the feasibility of procedures in other blood vessels such as the femoral artery. In a preferred embodiment, the tapered component (12) is always partially contained within the vascular catheter (22) while the guide device (10) guides the passage of the vascular catheter (22) through the blood vessel. In some embodiments, the first portion (15) of the tapered component (12) may always be contained within the vascular catheter (22).

[0075] In particular, the pushing means (14) does not extend to be coaxial with the longitudinal axis (100), whereas the guide wire extends substantially along the longitudinal axis (100). Consequently, the pushing means (14) does not interfere with the path of the guide wire (20). Importantly, the pushing means (14) is configured so that a portion of the guide wire radially adjacent to the pushing means (14) remains visible to the operator in use (i.e., when the pushing means (14) is used to move a tapered component (12) along the guide wire (20). Thus, the operator can keep the guide wire in sight so that the entire guide wire does not inadvertently advance into the blood vessel.

[0076] In a preferred embodiment illustrated in the drawing, the pushing means (14) comprises a wire having a rigidity that causes the tapered component (12) to advance within the blood vessel by pushing the wire. In an alternative embodiment, the pushing means (14) may take any alternative form that can advance the tapered component (12) and keeps the guide wire portion radially adjacent to the pushing means (14) visible to the operator in use. For example, the pushing means may comprise a rod. The wire or rod is only radially aligned with the guide wire within a small angular extent, thus providing sufficient means to push (and pull) the tapered component (12) without significantly obscuring the exposed guide wire (20) visually. Similarly, other preferred variations of the pushing means (14) may be aligned radially 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) may be manufactured of any suitable material that is hard enough to facilitate the advancement of the tapered component (12) in the vessel by the operation of the pushing means (14). In some embodiments, the pushing means (14) may be manufactured of metal (e.g., if the pushing means (14) is a wire or a rod).

[0077] FIG. 4 illustrates a cross-sectional view of an embodiment of a guide device (10) at the proximal end (12a) of a tapered component (12). In the embodiment illustrated in FIG. 4, the distal end of the pushing means (14) extends from the wall (12c). As previously described, the wall (12c) extends between the inner bore (13a) and the outer surface of the proximal end (12a) of the tapered component (12). The wall (12c) has a limited thickness. For example, in a 6F size catheter, the tapered component has a maximum diameter of less than 1.7 mm and an inner bore diameter of about 1.1 mm, and accordingly has a thickness of about 0.3 mm and provides a wall from which the pushing means extends. In some embodiments, the cross-section (40) of the pushing means (14) is non-circular to facilitate the connection of the pushing means (14) to the tapered component (12). In some embodiments, the non-circular cross section (40) is substantially along the length of the pushing means (14). For example, the non-circular cross section (40) may extend over 50%, 60%, 70%, 80%, or 90% or more of the length of the pushing means (14). In alternative embodiments, the cross section may vary along the length of the pushing means (14). The non-circular cross section (40) improves the attachment of the pushing means (14) to a wall (12c) having a limited thickness. The pushing means (14) having the non-circular cross section (40) has different bending characteristics along different axes of the cross-sectional profile. However, because the pushing means (14) is long (relative to its width) and its movement within the lumen of the guide catheter is restricted during use, the influence of the different bending characteristics of the pushing means (14) on the control of the tapered component (12) is minimal and within an acceptable level. In some embodiments, a non-circular cross-section (40) provides additional pushing possibilities to the pushing means (14) while maintaining the flexibility and small cross-sectional profile of the pushing means (14).

[0078] The pushing means (14) may have any non-circular cross-section (40) suitable for attachment to the tapered component (12) to provide the rigidity and flexibility required to advance the tapered component (12) along the guide wire (20). The pushing means (14) may also have a non-circular cross-section (40) that allows it to remain visible while using the guide wire. The cross-section (40) of the pushing means (14) may include a plurality of sides. For example, the cross-section (40) may have four sides. One or more of the plurality of sides may be curved sides. One or more of the curved sides may be convex or concave curves. Additionally, the cross-section may have a convex curved side and a concave curved side. In some embodiments, the cross-section (40) may include a curved side that conforms, for example, to a portion of the circumference of the internal bore (13a). Alternatively or additionally, the cross section (40) may include a curved side that corresponds to a portion of the outer surface circumference of the proximal end (12a) of the tapered component (12). Multiple sides of the cross section (40) may include adjacent sides of different lengths. In some embodiments, the cross section (40) of the pushing means (14) may have a first side having a length of 0.40 mm to 0.53 mm and a second side adjacent to the first side having a length of 0.20 mm to 0.30 mm. In some embodiments, there may be a well-defined corner between adjacent sides. Alternatively, the corner between adjacent sides of the profile may be rounded. The angle between a pair of adjacent sides may be 90°, greater than 90°, or less than 90°.

[0079] FIG. 5 illustrates an example of a cross-sectional profile of a pushing means (14) according to an embodiment of the present invention. However, the cross-section (40) of the pushing means (14) is not limited to the embodiment shown in FIG. 5. Additionally, in some embodiments, the cross-section (40) of the pushing means (14) may vary along the length of the pushing means (14). The cross-section (40) of the pushing means (14) may substantially be a rectangle (140, 240), a square (340), or an annular arc (440, 740). In some embodiments, the rectangle, square, or annular arc may have rounded corners (240, 440). The annular arc (440, 740) may include a curved side (441, 741) that corresponds to a portion of the circumference of the inner bore (13a) of the tapered component (12). Additionally or alternatively, the annular arc (440, 740) may include a curved side (442, 642) that corresponds to a portion of the circumference of the outer surface of the proximal end of the tapered component (12). In some embodiments, the cross-section (40) of the pushing means (14) may be substantially elliptical or oval (640). In an alternative embodiment, the cross-section (40) of the pushing means (14) may include a circular segment (840). The curved side (842) of the circular segment (840) may correspond to a portion of the circumference of the outer surface of the proximal end (12a) of the tapered component (12). In some embodiments, the cross-section (40) may be semicircular. In some embodiments, the cross-section (40) of the pushing means (14) may be an oblong-like shape (540, 940, 1040) having at least one curved side (542, 942, 1041). The curved side (542, 942) may correspond to a portion of the circumference of the outer surface of the proximal end (12a) of the tapered component (12). The curved side (1041) may correspond to a portion of the circumference of the inner bore (13a) of the tapered component (12).In some embodiments, the rectangular shape may include first and second sides, wherein the first end of each of the first and second sides is connected at a right angle to both ends of the third side. The third side may be longer than the first and second sides. The second end of each of the first and second sides is connected to both ends of the fourth side, wherein the fourth side is a curved side. The fourth side may be a convex or concave curve.

[0080] Once the pushing means (14) is used to advance the tapered component (12) into the vascular catheter (22) and the tapered component (12) extends beyond the distal end (22b) of the vascular catheter (22), the connector (18) can detachably connect the guide device (10) to the vascular catheter (22). FIGS. 6 and 7 illustrate the connector (18) according to an embodiment of the present invention. By connecting the guide device (10) to the vascular catheter (22), the guide device (10) can be prevented from being over-inserted into the vascular catheter (22). In particular, the connection between the guide device (10) and the vascular catheter (22) will determine the maximum range to which the tapered component (12) extends beyond the distal end (22b) of the vascular catheter (22). Additionally, the connection between the guide device (10) and the vascular catheter (22) will cause the guide device (10) and the vascular catheter (22) to move collectively as one along the guide wire (20) (i.e., with minimal relative movement between them).

[0081] In some embodiments, the connector (18) may be positioned at or toward the proximal end (10a) of the guide device (10). The connector (18) may be connected to a pushing means (14) at the rear of the proximal end (12a) of the tapered component (12). In some embodiments, the connector (18) may move along the pushing means so as to be connected to a vascular catheter (22) of various lengths.

[0082] The connector (18) can detachably connect the guide device (10) to the proximal end of the vascular catheter (22) by any suitable fixing mechanism, including but not limited to push fit and snap fit arrangements. In some embodiments, the connector may be rotatably connected to the vascular catheter (22). In these embodiments, the connector (18) includes a free-wheeling mechanism. The free-wheeling mechanism is configured to connect the connector (18) to the proximal end of the vascular catheter (22) without causing rotation of the pushing means (14). Thus, when the connector (18) is rotated to connect to the vascular catheter (22), the tapered component (12) is not rotated within the vascular catheter (22) or the blood vessel.

[0083] FIGS. 6 to 8 illustrate non-limiting embodiments of a connector (18) according to the present invention. FIGS. 6 and 7 show a connector (18) connected to a pushing means (14) in an assembled state, and FIG. 8 shows an exploded side view of the connector (18). The connector (18) includes a body (30), a locking tube (38), and a free-wheeling ring (24). When assembled, the body (30) and the free-wheeling ring (24) form a free-wheeling mechanism.

[0084] The main body (30) includes a bore (34) that extends through the main body (30) from the proximal end (30a) to the distal end (30b). The central axis of the bore (34) coincides with the longitudinal axis (100) of the guide device (10). The main body (30) has an annular rim (32). The rim (32) may be spaced proximally from the distal end (30b) of the main body (30). In an alternative embodiment, the rim may be at the distal end (30b) of the main body (30). The rim (32) may be continuous or may include a plurality of individual raised sections. The main body (30) includes a shoulder (38) spaced proximally from the rim (32). The shoulder (38) extends circumferentially around the main body (30). The shoulder (38) may be continuous or may include multiple individual 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 free-rotating ring (24). In some embodiments, the proximal end (30a) of the body (30) may include a thread (35) for connecting the body (30) to an additional component. In some embodiments, the body (30) may be a single injection molded body.

[0085] The free-rotating ring (24) includes an internal cavity (25) at the distal end of the ring (24). The internal cavity (25) includes a thread (26) for connecting to the proximal end of the catheter (22). In some embodiments, the internal cavity (25) may include a female luer thread. The free-rotating ring (24) includes a hole (27) at the proximal end of the ring (24). The hole extends through the proximal end wall of the free-rotating ring (24) into the internal cavity (25). The hole (27) is configured to accommodate the proximal end (30b) of the main body (30). The diameter of the hole (27) is configured to form a snap-fit ​​to the annular rim (32) and to be located between the annular rim (32) and the shoulder (38). The diameter of the hole (27) is smaller than the diameter of the rim (32) and the diameter of the shoulder (38).

[0086] During the assembly of the connector (18), the distal end (30b) of the main body (30) is inserted through the hole (27) of the free-rotating ring (24). The hole (27) of the free-rotating ring (24) is pushed over the rim (32), and the free-rotating ring (24) is retained within the channel (36). Thus, in the assembled state, the free-rotating ring (24) can rotate freely around the body (30), although its axial movement relative to the body (30) is restricted by the rim (32) and the shoulder (38). The axis of rotation of the free-rotating ring (24) may be the longitudinal axis (100).

[0087] The pushing means (14) is connected to the main body (30) by a locking tube (28). The outer diameter of the locking tube (28) is smaller than the diameter of the bore (34) of the main body (30). The inner diameter of the locking tube (28) is larger than the diameter of the guide wire (not shown).

[0088] While connecting the pushing means (14) to the main body (30), the pushing means (14) is inserted into the bore (34) of the main body (30). A locking tube (28) is also inserted into the bore (34) of the main body (30) with adhesive to firmly secure the locking tube (28) and the pushing means (14) within the main body (30). The locking tube (28) holds the pushing means (14) at a position radially offset with respect to the longitudinal axis (100). This corresponds to the pushing means (14) extending from the tapered component (12) at a position radially offset from the longitudinal axis (100).

[0089] When the connector (18) is assembled and the pushing means (14) is connected to the main body (30), the free-rotating ring (24) can be rotated to connect the connector (18) to the proximal end of the vascular catheter (22). Because the ring (24) rotates relative to the main body (30), the connection to the vascular catheter (22) does not rotate the pushing means (14). Consequently, when the guide device (10) is connected to the catheter, the tapered component (12) is not rotated within the vascular catheter (22) or the blood vessel. Thus, the connector (18) provides a secure connection between the guide device (10) and the vascular catheter (22) while preventing rotation of the tapered component (12).

[0090] When the vascular catheter (22) is advanced to a desired position within the blood vessel, the connector (18) can be detached from the vascular catheter (22), and the pushing means (14) can be pulled backward along the guide wire (20) to remove the guide device (10) from the blood vessel, and the vascular catheter (22) is left in place within the blood vessel. Advantageously, the guide device (10) can be used to reduce the risk of arterial spasm during a standard insertion procedure. This contrasts with the prior art method, which requires removing the standard guide wire and inserting additional components to continue advancing the catheter when encountering a restricted, tortuous, or spasmodic artery.

[0091] In addition to assisting in guiding the vascular catheter (22) in the blood vessel ahead of the advancing catheter, the guiding device (10) may be used to “relieve” cases where a jam or spasm occurs and the passage of the vascular catheter (22) along the guide wire in the blood vessel is blocked and further advancing of the vascular catheter (22) is inhibited or obstructed. In such situations, the guiding device (10) may advance along the guide wire and through the bore of the vascular catheter (22) so that the tapered component (12) may protrude from the distal end (22b) of the vascular catheter (22). To facilitate the advancing of the vascular catheter (22) within the blood vessel and / or to reduce pain and discomfort experienced by the patient, the tapered component (12) may dilate the blood vessel. Additionally, a guide device according to some embodiments of the present invention may be used with or without a sheath, as the device may be used as an inserter for a guide catheter and the combination may be known as a catheter without a sheath and may be universal in that it can be used with catheters and guide wires of all manufacturers.

[0092] In some preferred embodiments, the tapered component (12) may have a low-friction outer surface. A low-friction interface with the blood vessel wall facilitates the smooth movement of the tapered component in the blood vessel. In some embodiments, any lubricating and / or hydrophilic outer surface may provide this low-friction outer surface. In some embodiments, the hydrophilic outer surface may be provided by a hydrophilic coating applied to the tapered component (12). In an alternative embodiment, the hydrophilic outer surface may be provided by the surface topography of the tapered component (12) (e.g., a plurality of grooves, concaves, or other surface features that may impart hydrophilic properties to the tapered component (12)).

[0093] The tapered component (12) may be manufactured from any suitable material. In some embodiments, the tapered component (12) comprises a plastic material. Additionally or alternatively, the tapered component (12) may comprise an elastic material that can be deformed during use within a blood vessel. The tapered component (12) may be formed from a single material.

[0094] In some embodiments, the tapered component (14) has an axial length of up to 30 cm. In some embodiments, the tapered component (14) may have an axial length of 1 cm to 30 cm, or 14 cm to 25 cm. In some embodiments, the tapered component (14) has an axial length of about 14 cm. The tapered component (14) may have any axial length suitable for providing the required flexibility.

[0095] When the guide device (10) is used with a 6F catheter, the tapered component (12) may have an axial length of 14 cm, where the cylindrical first section (15) has an axial length of 10 cm and an axial length of 4 cm between the distal end (12b) of the tapered component and the cylindrical first section (15). The second section (17) may be a convex cone, where the taper of the cone corresponds to an arc of a circle with a radius between 2000 mm and 4000 mm. Additionally or alternatively, the third section (19) may be a concave cone where the taper of the cone corresponds to an arc of a circle with a radius between 2000 mm and 4000 mm.

[0096] In some embodiments, the maximum diameter of the tapered component (12) (e.g., in an uncompressed state) is smaller than the inner diameter of the catheter into which it is to be inserted. The tapered component may 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, for an 8F catheter, the maximum diameter may be less than 2.29 mm, for a 7F catheter, the maximum diameter may be less than 2.0 mm, and for a 6F catheter, the maximum diameter may be less than 1.7 mm. A skilled reader will understand that in this context, "F" signifies the French gauge system, where 1F is equivalent to a diameter of 1.3 mm.

[0097] To be compatible with the range of the guide wire (20), in some embodiments, the hole (13, 29) may be sized to allow a guide wire to pass through, with a diameter of about 0.5 mm to 1 mm, for example, 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 some non-limiting embodiments, the hole (13) may be larger than 0.36 mm (0.014") so that a guide wire (e.g., angioplasty wire) having a diameter of 0.36 mm (0.014") can pass through the tapered component (12).

[0098] The guide device (10) may be dimensionally compatible with known vascular catheters (22) and / or guide wires (20) and may otherwise be suitable for use together. It is preferable to use a guide device (10) of a single size with vascular catheters (22) of different lengths. To be dimensionally compatible with a specific vascular catheter (22), when the tapered component (12) is positioned protruding from the distal end (22b) of the vascular catheter (22), the pushing means (14) must be extended posteriorly beyond the proximal end of the vascular catheter (22). In some embodiments, the pushing means (14) may 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 some embodiments, the pushing means (14) may be provided with one or more markers (16) (see FIG. 1) to indicate the extended length of the guide device (10). For example, when a specific marker (16) is near the proximal end of the catheter (22), the extended length of the guide device (10) (and the vascular catheter (22) accordingly) can be inferred from the marker (16). In some non-limiting embodiments, the marker may include a visual marker and / or a non-visual marker, for example, a radiopaque marker (e.g., tungsten or barium). In some embodiments, one or more markers may be provided at any suitable location on the guide device (10) and not limited to the pushing means (14). A radiopaque marker located approximately 2 mm from the distal tip may indicate the location of the distal end of the device in fluoroscopic screening.

[0099] The present invention is defined in the appended claims. To avoid any doubt, the present invention is not necessarily limited to the specific features and dimensions discussed above. A skilled reader will also understand that the features (and dimensions) discussed above are not comprehensive and that embodiments of the present invention having different features and / or dimensions may be realized.

[0100] Throughout the description and claims of this specification, the words “comprising” and “containing” and variations thereof mean “comprising, but not limited to” and do not exclude other moiety, additive, component, integer, or step. Throughout the description and claims of this specification, singular expressions include plural expressions unless otherwise required by the context. In particular, where singular and plural expressions are not specified, it should be understood that the specification considers both singular and plural forms unless otherwise required by the context. The word “part” is not limited to monolithic structures and may relate to multi-part structures in some embodiments.

[0101] Features, integers, characteristics, compounds, chemical moiety, or groups described in connection with specific aspects, embodiments, or examples of the present invention should be understood to be applicable to any other aspects, embodiments, or examples described herein, except where they are incompatible. All features disclosed herein (including the appended claims, abstract, and drawings), and / or all steps of the method or process so disclosed, may be combined in any combination except for mutually exclusive combinations of at least some of such features and / or steps. The present invention is not limited to the details of any of the foregoing embodiments. The present invention extends to novel or novel combinations of features disclosed herein (including the appended claims, abstract, and drawings), or any novel or any novel combination of any method or process steps so disclosed.

[0102] Readers should be aware of all papers and documents submitted simultaneously with or prior to this specification in connection with this application and subject to public examination together with this specification, and all such documents and their contents are incorporated into this specification.

Claims

Claim 1 A guide device for a vascular catheter into which a guide wire is inserted, wherein the guide device comprises: a tapered component passing through the bore of the vascular catheter and extending at the distal end of the vascular catheter; a pushing means extending from the tapered component and extending beyond the proximal end of the vascular catheter, wherein the tapered component is provided with a hole through which the guide wire can pass so as to allow the tapered component to move along the guide wire, wherein the tapered component comprises a first section, a second section and a third section, wherein the first section is disposed between the proximal end of the tapered component and the second section, wherein the second section is disposed between the first section and the third section, and wherein the third section is disposed between the second section and the distal end of the tapered component, wherein the first section is a cylinder, and the second and third sections are conical, and the taper of the second section is different from the taper of the third section. Device. Claim 2 A guide device according to claim 1, wherein the second section is a convex conical section. Claim 3 A guide device according to claim 1, wherein the third section is a concave conical section. Claim 4 A guide device according to claim 1, wherein the proximal end of the first section coincides with the proximal end of the tapered component, and the diameter of the first section may be the maximum diameter of the tapered component. Claim 5 A guide device according to claim 1, wherein the distal end of the third section coincides with the distal end of the tapered component, and the minimum diameter of the tapered component may coincide with the distal end of the third section. Claim 6 A guide device according to claim 1, wherein the movement of the tapered component along the guide wire is controlled in a proximal direction from beyond the proximal end of the vascular catheter by the movement of the pushing means. Claim 7 In claim 6, the guide device comprises a connector connectable to the pushing means for detachably connecting the guide device to the proximal end of the vascular catheter. Claim 8 A guide device according to claim 7, wherein the connector comprises a free-wheel mechanism configured to allow connection of the connector to the proximal end of the vascular catheter without rotating the pushing means. Claim 9 In claim 8, the connector comprises a main body connectable to the pushing means and a free-rotating ring for connecting to the catheter, forming a guide device. Claim 10 In claim 9, the free-rotating ring is a guide device in which axial movement relative to the main body of the connector is restricted and it can freely rotate around the main body of the connector. Claim 11 A guide device according to claim 10, comprising a rim that restricts the movement of the free-rotating ring in a distal direction relative to the main body of the connector. Claim 12 In paragraph 7, the connector is a guide device that moves along the pushing means. Claim 13 In paragraph 6, the pushing means is a guide device having a non-circular cross-section. Claim 14 A guide device according to claim 13, wherein the cross-section of the pushing means has multiple sides, and the cross-section of the pushing means may have four sides. Claim 15 A guide device according to claim 14, wherein adjacent sides among the plurality of sides have different lengths, and / or the edges between adjacent sides among the plurality of sides are curved, and / or the plurality of sides include a first curved side. Claim 16 delete Claim 17 delete Claim 18 A guide device according to claim 14, wherein the plurality of sides includes a first curved side, and the first curved side corresponds to a portion of the circumference of the outer surface of the proximal end of the tapered component. Claim 19 In claim 1, the guide device comprises an internal bore accessible through the hole. Claim 20 A guide device according to claim 19, wherein the cross-section of the pushing means comprises a plurality of sides, and the plurality of sides include a second curved side that corresponds to a part of the circumference of the inner bore of the tapered component. Claim 21 delete Claim 22 delete Claim 23 delete Claim 24 delete Claim 25 delete Claim 26 delete Claim 27 delete Claim 28 delete Claim 29 delete Claim 30 delete Claim 31 delete Claim 32 delete Claim 33 delete Claim 34 delete Claim 35 A guide device for a vascular catheter into which a guide wire is inserted, wherein the guide device comprises: a tapered component passing through the bore of the vascular catheter and extending from the distal end of the vascular catheter; a pushing means configured to extend from the tapered component and extend beyond the proximal end of the vascular catheter; and a connector for detachably connecting the guide device to the proximal end of the vascular catheter, wherein the tapered component has a hole through which the guide wire can pass so that the tapered component can move along the guide wire, the connector is connectable to the pushing means, and the connector includes a free rotation mechanism configured to allow connection of the connector to the proximal end of the vascular catheter without rotating the pushing means, wherein the movement of the tapered component along the guide wire is controllable beyond the proximal end of the vascular catheter by the movement of the pushing means. Claim 36 delete Claim 37 delete Claim 38 delete Claim 39 delete Claim 40 delete Claim 41 delete Claim 42 delete Claim 43 delete Claim 44 delete Claim 45 delete Claim 46 delete Claim 47 delete Claim 48 delete Claim 49 delete Claim 50 delete Claim 51 delete Claim 52 delete Claim 53 delete Claim 54 delete Claim 55 delete

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