Guide devices for vascular catheters

Abstract

A guiding device for inserting a vascular catheter (22) above a guide wire. The guiding device includes a tapered component (12) for passing through a hole of the vascular catheter (22) and extending from the distal end of the vascular catheter. The tapered component (12) has an orifice (13) through which the guide wire can pass, so that the tapered component (12) can move along the guide wire. A pushing device (14) extends from the tapered component (12) and is configured to extend beyond the proximal end of the vascular catheter (22). The tapered component (12) includes a first section (15), a second section (17), and a third section (19). The first section (15) is arranged between the proximal end of the tapered component (12b) and the second section (17), the second section (17) is arranged between the first section (15) and the third section (19), and the third section (19) is arranged between the second section (17) and the distal end of the tapered component (12). The first section (15) is cylindrical, and the second and third sections (17, 19) are conical. The taper of the second section (17) is different from the taper of the third section (19).

Description

[0001] The present invention relates to a guiding device for a vascular catheter, and in particular, to a guiding device that can help improve the passage of a catheter through a blood vessel. Background Art

[0002] Arterial disease is currently the leading cause of death in the UK and worldwide. It is caused by stenosis (atherosclerosis) caused by fatty deposits. The coronary arteries run along the surface of the heart and supply blood to the heart muscle. For example, the stenosis associated with coronary heart disease restricts blood flow, and this can deprive the heart muscle of its vital oxygen supply. In order to access the coronary arteries and other arteries, practitioners need to insert a catheter into the vascular system. To access the coronary arteries, for the most common vascular interventions, the catheter is traditionally inserted via the femoral artery. Recently, the use of the radial artery has become more common. The most common surgery to treat coronary heart disease is called coronary angioplasty or percutaneous coronary intervention (PCI) (commonly referred to as "stenting").

[0003] In this procedure, narrowing in the coronary arteries is identified by injecting contrast dye under X-ray guidance. A balloon is inflated to relieve the narrowing, and a stent (metal mesh tube) is inserted. The stent is used to keep the artery open and restore blood flow. In the UK, around 100,000 PCI procedures are performed each year.

[0004] Catheters are used to deliver contrast media and angioplasty equipment including wires, balloons, and stents. Due to the technical requirements placed on the vascular catheter, it is usually made of relatively stiff materials and formed into a cylindrical tube. The advancement of the vascular catheter through the artery in the arm often causes the so-called "razor effect", in which the edge of the vascular catheter scrapes the arterial wall. This is painful for the patient, can cause arterial spasm and can cause lacerations and serious bleeding complications.

[0005] When spasms or lacerations occur, surgery is often delayed while the patient is given a combination of sedatives, painkillers (e.g., anesthetics), and arteriolar dilators. In some cases, surgery must be completed via a different artery or even abandoned altogether. If surgery is instead completed via the femoral artery, there is an additional risk of bleeding and major complications.

[0006] Although the prior art provides certain solutions to help reduce the risk of some of these problems, these solutions often require expensive equipment. In addition, many prior art solutions are not compatible with standard equipment and are only compatible with specific catheter hardware, so multiple devices are required to enable selection of the appropriate device for use with a specific catheter.

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

[0008] BRIEF DESCRIPTION OF THE DISCLOSURE

[0009] According to a first aspect of the present invention, there is provided a guiding device for inserting a vascular catheter over a guide wire, the guiding device comprising:

[0010] a tapered member for passing through the bore of the vascular catheter and extending from the distal end of the vascular catheter,

[0011] The tapered member has an aperture through which a guide wire can pass, so that the tapered member can move along the guide wire; and

[0012] a pusher extending from the tapered member and configured to extend beyond the proximal end of the vascular catheter;

[0013] Wherein, the conical component includes a first section, a second section and a third section; the first section is arranged between the proximal end of the conical component and the second section; the second section is arranged between the first section and the third section; and the third section is arranged between the second section and the distal end of the conical component;

[0014] The first section is a cylinder, 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.

[0015] In some embodiments, the second section may be a convex conical section. The third section may be a concave conical section. In some embodiments, the proximal end of the first section may coincide with the proximal end of the conical component. The diameter of the first section may be the maximum diameter of the conical component. In some embodiments, the distal end of the third section may coincide with the distal end of the conical component. The minimum diameter of the conical component may coincide with the distal end of the third section.

[0016] Movement of the tapered member proximally from outside the proximal end of the vascular catheter along the guidewire is controllable by movement of the push device.

[0017] The guiding device may include a connector connectable to a pusher for releasably connecting the guiding device to the proximal end of the vascular catheter. The connector may include an idling mechanism configured to allow the connector to be connected to the proximal end of the vascular catheter without causing rotation of the pusher. In some embodiments, the connector may include a body connectable to the pusher and an idling ring for connecting to the catheter. The idling ring may be axially limited relative to the body of the connector and may rotate freely around the body of the connector. The edge may limit the idling ring in the distal direction relative to the body of the connector. The connector can move along the pusher.

[0018] In some embodiments, the pusher can have a non-circular cross section. The cross section of the pusher can have multiple sides. The cross section of the pusher can have four sides. Adjacent sides can have different lengths. The corners between adjacent sides can be rounded. In some embodiments, the multiple sides can include a first curved side. The first curved side can conform to a portion of the perimeter of the outer surface of the proximal end of the tapered component.

[0019] In certain embodiments, the guide device may include an inner bore accessible through the aperture.The plurality of sides of the urging device may include a second curved side that conforms to a portion of the periphery of the inner bore of the tapered component.

[0020] In certain embodiments, the pusher device may be arranged to allow a portion of the guidewire radially adjacent the pusher device to remain visible to an operator during use.

[0021] According to a second aspect of the present invention, there is provided a guiding device for inserting a vascular catheter over a guide wire, the guiding device comprising:

[0022] a tapered member for passing through the bore of the vascular catheter and extending from the distal end of the vascular catheter, the tapered member having an aperture through which a guidewire may pass so that the tapered member may move along the guidewire; and

[0023] a pusher having a non-circular cross-section and extending from the tapered member, the pusher being configured to extend beyond the proximal end of the vascular catheter;

[0024] Therein, movement of the tapered component along the guidewire is controllable from outside the proximal end of the vascular catheter by movement of the push device.

[0025] In some embodiments, the cross section of the pusher may have multiple sides. The cross section of the pusher may have four sides. Adjacent sides may have different lengths. 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 conform to a portion of the periphery of the outer surface of the proximal end of the tapered component.

[0026] In certain embodiments, the guide device may include an inner bore accessible through the aperture. The plurality of sides of the urging device may include a second curved side that conforms to a portion of the periphery of the inner bore of the tapered component.

[0027] The guiding device may include a connector connectable to the pushing device for releasably connecting the guiding device to the proximal end of the vascular catheter. In some embodiments, the connector may include a lost motion mechanism configured to allow the connector to be connected to the proximal end of the vascular catheter without causing rotation of the pushing device. In some embodiments, the connector may include a body connectable to the pushing device and a lost motion ring for connecting to the catheter. The lost motion ring may be axially limited relative to the body of the connector and may rotate freely around the body of the connector. The edge may limit the lost motion ring in the distal direction relative to the body of the connector. The connector may move along the pushing device.

[0028] In some embodiments, the conical component may include a first section, a second section, and a third section. The first section may be disposed between the proximal end of the conical component and the second section. The second section may be disposed between the first section and the third section. The third section may be disposed between the second section and the distal end of the conical component. The first section may be a cylinder. The second section and the third section may be conical, and the taper of the second section is different from the taper of the third section.

[0029] In some embodiments, the second section may be a convex conical section. The third section may be a concave conical section. In some embodiments, the proximal end of the first section may coincide with the proximal end of the conical component. The diameter of the first section may be the maximum diameter of the conical component. In some embodiments, the distal end of the third section may coincide with the distal end of the conical component. The minimum diameter of the conical component may coincide with the distal end of the third section.

[0030] In certain embodiments, the pusher device may be arranged to allow a portion of the guidewire radially adjacent the pusher device to remain visible to an operator during use.

[0031] According to a third aspect of the present invention, there is provided a guiding device for inserting a vascular catheter over a guide wire, the guiding device comprising:

[0032] a tapered member for passing through the bore of the vascular catheter and extending from the distal end of the vascular catheter, the tapered member having an aperture through which a guidewire may pass so that the tapered member may move along the guidewire; and

[0033] a pusher extending from the tapered member and configured to extend beyond the proximal end of the vascular catheter; and

[0034] a connector for releasably connecting a guide device to the proximal end of the vascular catheter;

[0035] wherein the connector is connectable to the pusher device and includes a lost motion mechanism configured to allow the connector to be connected to the proximal end of the vascular catheter without causing rotation of the pusher device; and

[0036] Movement of the tapered member along the guidewire is controllable from outside the proximal end of the vascular catheter by movement of the push device.

[0037] In some embodiments, the connector may include a body connectable to the push device and an idle ring for connecting to the catheter. The idle ring may be axially constrained relative to the body of the connector and may rotate freely around the body of the connector. The edge may constrain the idle ring in a distal direction relative to the body of the connector. The connector may move along the push device.

[0038] In some embodiments, the pusher can have a non-circular cross section. The cross section of the pusher can have multiple sides. The cross section of the pusher can have four sides. Adjacent sides can have different lengths. The corners between adjacent sides can be rounded. In some embodiments, the multiple sides can include a first curved side. The first curved side can conform to a portion of the perimeter of the outer surface of the proximal end of the tapered component.

[0039] In certain embodiments, the guide device may include an inner bore accessible through the aperture.The plurality of sides of the urging device may include a second curved side that conforms to a portion of the periphery of the inner bore of the tapered component.

[0040] In some embodiments, the conical component may include a first section, a second section, and a third section. The first section may be disposed between the proximal end of the conical component and the second section. The second section may be disposed between the first section and the third section. The third section may be disposed between the second section and the distal end of the conical component. The first section may be a cylinder. The second section and the third section may be conical, and the taper of the second section is different from the taper of the third section.

[0041] In some embodiments, the second section may be a convex conical section. The third section may be a concave conical section. In some embodiments, the proximal end of the first section may coincide with the proximal end of the conical component. The diameter of the first section may be the maximum diameter of the conical component. In some embodiments, the distal end of the third section may coincide with the distal end of the conical component. The minimum diameter of the conical component may coincide with the distal end of the third section.

[0042] In certain embodiments, the pusher device may be arranged to allow a portion of the guidewire radially adjacent the pusher device to remain visible to an operator during use.

[0043] In any of the first, second and third aspects of the present invention, the tapered component may have a low friction outer surface. In certain embodiments, the low friction outer surface may include a hydrophilic outer surface.

[0044] In certain embodiments, the urging device may include a wire extending from a tapered member.

[0045] In certain embodiments, the tapered component may have an axial length of between 10 cm and 30 cm, and optionally between 14 cm and 25 cm. In certain embodiments, the tapered component may have an axial length of approximately 20 cm.

[0046] The pushing device 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 part.

[0047] In certain embodiments, the orifice may be sized to allow passage of a guidewire 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”).

[0048] 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 some embodiments, the maximum outer diameter can coincide with the proximal end of the tapered component, and the tapered component can taper from the minimum outer diameter at the distal end of the tapered component to the maximum outer diameter.

[0049] The guide device may also include a radiopaque material. In some embodiments, the tapered portion may include a radiopaque material. In a non-limiting embodiment, the radiopaque material may be barium sulfate. In some embodiments, the guide device may also include one or more markers. The one or more markers may 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 may be disposed on the tapered portion. In an alternative embodiment, one or more markers may be disposed on the push device, for example to indicate the deployed length of the guide device. In some embodiments, the guide device may include ink or a physical tape that makes the distal end of the tapered portion visible to x-rays and other medical imaging techniques.

[0050] In certain embodiments, the tapered component may include a plastic material.

[0051] In certain embodiments, the urging device may include metal and / or plastic materials.

[0052] According to another aspect of the present invention, there is provided a kit, the kit comprising:

[0053] A boot device as described above; and

[0054] Vascular catheters;

[0055] Therein, the tapered component of the guide device is configured to pass through the bore of the vascular catheter and extend from the distal end of the vascular catheter.

[0056] The kit may further include a guidewire, wherein the aperture of the tapered component may allow the guidewire to pass therethrough such that the tapered component may be moved along the guidewire.

[0057] According to another aspect of the present invention, there is provided a kit, the kit comprising:

[0058] A boot device as described above;

[0059] Guidewire;

[0060] The aperture of the tapered component may allow a guide wire to pass therethrough, so that the tapered component may move along the guide wire.

[0061] BRIEF DESCRIPTION OF THE DRAWINGS

[0062] Embodiments of the present invention are further described below with reference to the accompanying drawings, in which:

[0063] Figure 1A is a schematic side view of a guide device according to an embodiment of the present invention;

[0064] Figure 1B is a schematic side view of a guide device for use with a catheter according to an embodiment of the present invention;

[0065] Figure 2 is a schematic side view of a portion of a guide device according to an embodiment of the present invention;

[0066] Figure 3 is a schematic side view of a portion of a guide device for use with a catheter and a guidewire according to an embodiment of the present invention;

[0067] Figure 4 is a schematic cross-section of a guiding device according to an embodiment of the present invention;

[0068] Figure 5 is a schematic cross-section of a push device of a guiding apparatus according to an embodiment of the present invention;

[0069] Figure 6 is a schematic cross-section of a distal end of a connector for guiding a device according to an embodiment of the present invention;

[0070] Figure 7 is a schematic side view of a connector for guiding a device according to an embodiment of the present invention; and

[0071] Figure 8is an exploded schematic side view of a connector for guiding a device according to an embodiment of the present invention.

[0072] Details

[0073] Figure 1A and Figure 1B A schematic side view of a guide device 10 according to an embodiment of the present invention is shown. Guide device 10 may facilitate improved passage of a vascular catheter through a peripheral blood vessel, such as the radial artery.

[0074] The guide device 10 extends between the proximal end 10a and the distal end 10b along the longitudinal axis 100. Throughout the specification, references to a forward direction or a distal direction (and similar directions) relate to a direction parallel to the longitudinal axis 100 toward the distal end 10b (or away from the proximal end 10a). Similarly, references to a rearward direction or a proximal direction (and similar directions) relate to a direction parallel to the longitudinal axis 100 toward the proximal end 10a (or away from the distal end 10b). References to axial directions, etc., relate to directions parallel to the longitudinal axis 100. References to radial directions, etc., relate to directions extending orthogonal to the longitudinal axis 100, wherein radially outward positions are farther from the longitudinal axis 100 than radially inward positions. References to circumferential directions, etc., relate to a path that follows the circumference (partially or completely) of an imaginary circle, the plane of which extends orthogonal to the longitudinal axis 100. References to cross-sections relate to cross-sections in a plane perpendicular to the longitudinal axis 100.

[0075] The guide device 10 includes a tapered component 12 extending from a proximal end 12a to a distal end 12b generally along a longitudinal axis 100. 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 tapers (i.e., increases in diameter) from a minimum diameter at its distal end 12b to a larger diameter behind the distal end 12b. In some embodiments, the maximum diameter can coincide with the proximal end 12a of the tapered component 12.

[0076] In some embodiments, the shape of the cone changes along the tapered portion 12 between the proximal end 12a and the distal end 12b. Figure 2 In the embodiment shown in , the conical component 12 includes a first section 15, a second section 17 and a third section 19. Each section adopts a different shape. However, the outer contour of the resulting conical 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 conical component 12 and the second section 17. Figure 2In the embodiment shown in , the first section 15 is in 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 disposed between the first section 15 and the third section 19. Figure 2 In the embodiment shown in , the second section 17 is in the form of a convex cone. 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 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 conical component 12. Figure 2 In the embodiment shown in , the third section adopts the form of a concave cone. That is, the tapered profile of the cone follows a concave curve. The diameter of the cross section 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, 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 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 12b 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. Relative to the prior art, the above-mentioned shape of the tapered component 12 provides it with improved flexibility, enabling it to effectively navigate through blood vessels. Therefore, in some embodiments, the tapered component 12 can be manufactured without having to change the material or material properties (such as hardness) along its length.

[0077] In other embodiments, the tapered component can take any alternative shape that can provide it with the required flexibility. In alternative embodiments, the tapered component can include different numbers of segments. For example, the fourth segment can extend distally from the third segment. The fourth segment (not shown) can take the form of a cylinder. In addition or alternatively, the fifth segment can extend proximally from the first segment. The fifth segment (not shown) can take the form of a cylinder. In some embodiments, additional segments can be provided between the first segment 15 and the second segment 17 and / or between the second segment 17 and the third segment 19. In addition, the shape of each segment can take different forms. The second segment 17 can take the form of a cone (i.e., the contour of the cone of the cone follows a straight line). Alternatively, the second segment 17 can take the form of a concave cone, or the second segment 17 can have a rounded or parabolic cone. The third segment 19 can take the form of a cone (i.e., the contour of the cone of the cone follows a straight line). Alternatively, the third section 19 may take the form of a convex cone, or the third section 19 may have a rounded or parabolic taper. In certain embodiments, the taper of the second section 17 may be different from the taper of the third section 19. For example, the taper of the second section 17 may be steeper (at least partially) than the taper of the third section 19 relative to the longitudinal axis 100.

[0078] The conical component 12 includes an orifice 13 at its distal end 12b. The conical component 12 is hollow so that an inner bore 13a of the conical component 12 is accessible through the orifice 13. The inner bore 13a of the conical component 12 extends to the proximal end 12a of the conical component 12 so that it is also accessible from the proximal end 12a. Thus, the inner bore 13a extends through all sections of the conical component 12. The inner bore 13a may have a constant diameter from the proximal end 12a to the distal end 12b of the conical component 12. The inner bore 13a may be accessible through a second orifice 13b in the proximal end 12a of the conical component 12. The wall 12c may extend between the inner bore 13a and the outer surface of the proximal end 12a of the conical component 12. In some embodiments, at least a portion of the wall 12c may be substantially perpendicular to the longitudinal axis 100. Additionally or alternatively, at least a portion of the wall 12c may be inclined relative to the longitudinal axis 100. Thereby, the wall 12c may provide a tapered opening for the second aperture 13b.

[0079] The guiding device 10 also includes a pusher 14 (e.g., a pusher in the form of a pusher component or component assembly) extending rearward from the tapered component 12. The pusher 14 can additionally extend from a position on the tapered component 12 that is axially forward of the proximal end 12a of the tapered component 12. The pusher 14 can be inserted into a groove in the tapered component 12. When the pusher 14 extends proximally from the tapered component 12 to outside the blood vessel (and to the body), the pusher 14 is sufficiently rigid to move the tapered component 12 forward and backward through the blood vessel. Despite this rigidity, the pusher 14 is sufficiently flexible so that it can bend and follow the contour of the blood vessel as it passes through the blood vessel.

[0080] The guide device 10 additionally includes a connector 18 connected to the pusher device 14. The connector 18 can facilitate easier manipulation and movement of the pusher device from outside the blood vessel. The connector 18 can be configured to releasably connect the guide device 10 to the proximal end 22a of the vascular catheter 22.

[0081] refer to Figure 1B and Figure 3 In use, the device 10 is introduced through the bore of the vascular catheter 22 so that at least a portion of the tapered member 12 extends from the distal end 22b of the vascular catheter 22. Figure 1B and Figure 3 In the schematic side view of the present invention, the vascular catheter 22 is shown as translucent to help understand the embodiment described in the present invention. The length of the vascular catheter depicted in the figure is shortened relative to the length of the tapered component to facilitate understanding of the embodiment. The term vascular catheter refers to any suitable catheter for use in a blood vessel (i.e., an artery or vein). The tapered component 12 and the vascular catheter 22 are threadedly connected on a guide wire (not shown) so that the guide wire passes through the orifice 13 of the tapered component 12, through the inner hole 13a of the tapered component 12 and through the hole of the vascular catheter 22. In this configuration, the guide wire extends forward from the distal end 12b of the tapered component 12 and extends backward from the proximal end (not shown) of the vascular catheter 22.

[0082] Behind the proximal end of the vascular catheter 22, the guide wire and the pusher 14 extend side by side with each other. In this way, the axial movement of the pusher 14 causes the tapered component 12 to move axially along the guide wire. In use, the guide wire can be arranged in the blood vessel so that it can guide the vascular catheter 22 through, while the proximal end of the vascular catheter 22 remains outside the blood vessel. In view of the fact 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 in the blood vessel. Thus, it is easier to pass the vascular catheter 22 through the blood vessel by the tapered component 12, thereby substantially avoiding the "razor effect" of the front edge of the distal end 22b of the vascular catheter 22 in its interaction with the inner wall of the blood vessel. Therefore, just as the risk of spasm of the blood vessel is reduced, the risk of the vascular catheter 22 hanging on the blood vessel wall is reduced. Therefore, patient comfort can be improved. These advantages can be used to increase the success rate of procedures such as coronary angioplasty or percutaneous coronary intervention (PCI) in blood vessels such as the radial and brachial arteries, thereby improving their feasibility in other blood vessels such as the femoral artery. In a preferred embodiment, the tapered member 12 is always partially contained within the vascular catheter 22 while the guide device 10 guides the vascular catheter 22 through the blood vessel. In some embodiments, the first section 15 of the tapered member 12 can always be contained within the vascular catheter 22.

[0083] It is noteworthy that the pusher 14 does not extend coaxially with the longitudinal axis 100, while the guide wire extends substantially along the longitudinal axis 100. Therefore, the pusher 14 does not interfere with the path of the guide wire. Importantly, the pusher 14 is configured so that a portion of the guide wire radially adjacent to the pusher 14 remains visible to the operator during use (i.e., when the pusher 14 is used to move the tapered member 12 along the guide wire). Therefore, the operator can keep the guide wire visible to ensure that the entire guide wire is not accidentally advanced into the blood vessel.

[0084] In the preferred embodiment shown in the figure, the pusher 14 comprises a wire having a hardness that allows the tapered component 12 to be advanced in the blood vessel by pushing the wire. In an alternative embodiment, the pusher 14 can adopt any alternative form that can advance the tapered component 12 and allow the radially adjacent part of the guide wire to remain visible to the operator in use. For example, the pusher can include a rod. The wire or rod are only aligned radially with the guide wire in a small angle range, and therefore provide enough means to promote (and pull) the tapered component 12, without significantly visually blurring the exposed guide wire. Similarly, other preferred variations of the pusher 14 can be aligned radially with the guide wire in a small angle range (for example, less than 180 °, less than 90 °, less than 45 °, less than 20 °, less than 10 ° or less than 5 °). The pusher 14 can be made of any suitable material, and the material is sufficiently rigid, so that the tapered component 12 is advanced in the blood vessel by manipulating the pusher 14. In some embodiments, the pushing device 14 can be made of metal (eg, if the pushing device 14 is a wire or a rod).

[0085] Figure 4 A cross section of an embodiment of the guiding device 10 is shown at the proximal end 12a of the tapered component 12. Figure 4 In the embodiment shown in , the distal end of the pusher 14 extends from the wall 12c. As described above, the wall 12c extends between the inner hole 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 1.7mm and an inner hole diameter of about 1.1mm, thereby providing a wall with a thickness of about 0.3mm, and the pusher extends from the wall. In some embodiments, the cross section 40 of the pusher 14 is non-circular, so that the pusher 14 is connected to the tapered component 12. In some embodiments, the non-circular cross section 40 substantially runs through the length of the pusher 14. For example, the non-circular cross section 40 can run through more than 50%, 60%, 70%, 80% or 90% of the length of the pusher 14. In alternative embodiments, the cross section can change along the length of the pusher 14. The non-circular cross section 40 improves the attachment of the pusher 14 to the wall 12c with a limited thickness. The pusher 14 having a non-circular cross section 40 has different bending characteristics along different axes of the cross-sectional profile. However, because the pusher 14 is long (relative to its width) and is constrained within the lumen of the guide catheter during use, the effect of the different bending characteristics of the pusher 14 on the control of the tapered component 12 is minimal and within acceptable levels. In certain embodiments, the non-circular cross section 40 provides additional pushability to the pusher 14 while maintaining the flexibility and small cross-sectional profile of the pusher 14.

[0086] The pusher 14 can adopt any non-circular cross-section 40 suitable for attachment to the tapered component 12, which can provide the rigidity and flexibility required for advancing the tapered component 12 along the guidewire. The pusher 14 can also adopt a non-circular cross-section 40 that ensures that the guidewire remains visible during use. The cross-section 40 of the pusher 14 may include multiple edges. For example, the cross-section 40 may have four edges. One or more of the multiple edges may be curved edges. One or more curved edges may be convex or concave curves. In addition, the cross-section may have convex and concave curved edges. In some embodiments, the cross-section 40 may include a curved edge that, for example, conforms to a portion of the periphery of the inner hole 13a. Alternatively or in addition, the cross-section 40 may include a curved edge that conforms to a portion of the periphery of the outer surface of the proximal end 12a of the tapered component 12. The multiple edges of the cross-section 40 may include adjacent edges with different lengths. In some embodiments, the cross section 40 of the pusher 14 can have a first side with a length between 0.40 mm and 0.53 mm and a second side with a length between 0.20 mm and 0.30 mm adjacent to the first side. In some embodiments, there can be a well-defined corner between adjacent sides. Alternatively, the corner between adjacent sides of the profile can be rounded. The angle between a pair of adjacent sides can be 90°, greater than 90°, or less than 90°.

[0087] Figure 5 1 shows an example of a cross-sectional profile of the pusher 14 according to an embodiment of the present invention. However, the cross-sectional profile 40 of the pusher 14 is not limited to Figure 5. In addition, in some embodiments, the cross-section 40 of the pusher 14 may vary along the length of the pusher 14. The cross-section 40 of the pusher 14 may be substantially rectangular 140, 240, square 340, or annular arc 440, 740. In some embodiments, the rectangle, square, or annular arc may have rounded corners. The annular arc 440, 740 may include a curved edge 441, 741 that conforms to a portion of the periphery of the inner hole 13a of the tapered component 12. In addition or alternatively, the annular arc 40d, 40g may include a curved edge 442, 742 that conforms to a portion of the periphery of the outer surface of the proximal end 12a of the tapered component 12. In some embodiments, the cross-section 40 of the pusher 14 may be substantially elliptical or oval 640. In an alternative embodiment, the cross-section 40 of the pusher 14 may include a circular segment 840. The curved edge 842 of the circular segment 840 may conform to a portion of the periphery of the outer surface of the proximal end 12a of the tapered component 12. In some embodiments, the cross section 40 may be a semicircular shape. In some embodiments, the cross section 40 of the pusher 14 may be a similar rectangular shape 540, 940, 1040 having at least one curved edge 542, 942, 1041. The curved edge 542, 942 may conform to a portion of the periphery of the outer surface of the proximal end 12a of the tapered component 12. The curved edge 1041 may conform to a portion of the periphery of the inner hole 13a of the tapered component 12. In some embodiments, the similar rectangular shape may include a first side and a second side, wherein the first end of each of the first side and the second side is joined at right angles to the opposite end of the third side. The third side may be longer than the first side and the second side. The second ends of the first side and the second side may be joined to the opposite ends of the fourth side, wherein the fourth side is a curved side. The fourth side may be a convex curve or a concave curve.

[0088] Once the pushing device 14 has been used to advance the tapered component 12 into the vascular catheter 22 such that the tapered component 12 extends beyond the distal end 22 b of the vascular catheter 22 , the connector 18 may releasably connect the guiding apparatus 10 to the vascular catheter 22 . Figure 6 and Figure 7 A connector 18 according to an embodiment of the present invention is shown. By connecting the guide device 10 to the vascular catheter 22, over-insertion of the guide device 10 in the vascular catheter 22 can be prevented. Specifically, the connection between the guide device 10 and the vascular catheter 22 will determine the maximum extent to which the tapered member 12 extends beyond the distal end 22b of the vascular catheter 22. In addition, the connection between the guide device 10 and the vascular catheter 22 will cause the guide device 10 and the vascular catheter to move along the guidewire as one (i.e., with minimal relative movement between them).

[0089] In some embodiments, the connector 18 can be located at or toward the proximal end 10a of the guide device 10. The connector 18 can be connected to the pusher 14 behind the proximal end 12a of the tapered member 12. In some embodiments, the connector 18 can be moved along the pusher so that it can be engaged with vascular catheters 22 of different lengths.

[0090] The connector 18 can releasably 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 ​​devices. In some embodiments, the connector can be rotatably connected to the vascular catheter 22. In such embodiments, the connector 18 includes a lost motion mechanism. The lost motion mechanism is configured to allow the connector 18 to be connected to the proximal end of the vascular catheter 22 without causing rotation of the push device 14. Therefore, when the connector 18 is rotated to connect it to the vascular catheter 22, the tapered component 12 does not rotate within the vascular catheter 22 or the blood vessel.

[0091] Figures 6 to 8 A non-limiting embodiment of a connector 18 according to the present invention is shown. Figure 6 and Figure 7 The connector 18 is shown in an assembled state and connected to the push device 14, while Figure 8 An exploded side view of connector 18 is shown. Connector 18 includes body 30, locking tube 28, and lost motion ring 24. When assembled, body 30 and lost motion ring 24 form a lost motion mechanism.

[0092] The body 30 includes a hole 34 extending from the proximal end 30a to the distal end 30b through the body 30. The central axis of the hole 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 apart from the distal end 30b of the body 30 proximally. In an alternative embodiment, the rim can be located at the distal end 30b of the body 30. The rim 32 can be continuous or can include a plurality of separate raised sections. The body 30 includes a shoulder 38 spaced apart from the rim 32 proximally. The shoulder 38 extends circumferentially around the body 30. The shoulder 38 can be continuous or can include a plurality of separate raised sections. A channel 36 is formed between the rim 32 and the shoulder 38. The channel 36 is configured to receive a portion of the idler ring 24. In some embodiments, the proximal end 30a of the body 30 can include a thread 35 for connecting the body 30 to an additional component. In some embodiments, the body 30 can be a single injection molding.

[0093] The idler ring 24 includes an inner cavity 25 at the distal end of the ring 24. The inner cavity 25 includes threads 26 for connecting to the proximal end of the vascular catheter 22. In some embodiments, the inner cavity 25 may include female Luer threads. The idler ring 24 includes an orifice 27 at the proximal end of the ring 24. The orifice extends through the proximal wall of the idler ring 24 into the inner cavity 25. The orifice 27 is configured to receive the proximal end 30a of the body 30. The diameter of the orifice 27 is configured to form a snap fit on the annular rim 32 and is located between the annular rim 32 and the shoulder 38. The diameter of the orifice 27 is smaller than the diameter of the rim 32 and the diameter of the shoulder 38.

[0094] During assembly of connector 18, proximal end 30a of body 30 is inserted through aperture 27 of idler ring 24. Rim 32 is pushed over aperture 27 of idler ring 24 so that idler ring 24 is retained within channel 36. Thus, in the assembled state, idler ring 24 is axially restrained relative to body 30 by rim 32 and shoulder 38, but is able to rotate freely about body 30. The axis of rotation of idler ring 24 may be longitudinal axis 100.

[0095] The pusher 14 is connected to the body 30 by a locking tube 28. The outer diameter of the locking tube 28 is smaller than the diameter of the hole 34 of the body 30. The inner diameter of the locking tube 28 is larger than the diameter of the guide wire (not shown).

[0096] During the connection of the pusher 14 to the body 30, the pusher 14 is inserted into the hole 34 of the body 30. The locking tube 28 is also inserted into the hole 34 of the body 30 with an adhesive to securely hold the locking tube 28 and the pusher 14 within the body 30. The locking tube 28 holds the pusher 14 at a radially offset position relative to the longitudinal axis 100. This corresponds to the pusher 14 extending from the tapered component 12 at a radially offset position from the longitudinal axis 100.

[0097] Once the connector 18 has been assembled and the pusher 14 is connected to the body 30, the idler ring 24 can be rotated to connect the connector 18 to the proximal end of the vascular catheter 22. Since the idler ring 24 rotates relative to the body 30, the connection with the vascular catheter 22 does not cause the pusher 14 to rotate. Therefore, when the guide device 10 is connected to the catheter, the tapered component 12 does not rotate within the vascular catheter 22 or the blood vessel. Therefore, the connector 18 provides a secure connection between the guide device 10 and the vascular catheter 22 while avoiding rotation of the tapered component 12.

[0098] Once the vascular catheter 22 has been advanced to the desired position within the blood vessel, the connector 18 can be separated from the vascular catheter 22, and the pusher 14 can be pulled back to retract the guide device 10 from the blood vessel along the guide wire, thereby retaining the vascular catheter 22 in place. Advantageously, the guide device 10 can be used to reduce the risk of arterial spasm during standard interventional procedures. This is in contrast to some prior art methods, in which, once a restricted, tortuous or spasmodic artery is encountered, the standard guide wire must be removed and additional components inserted to allow the catheter to continue to advance.

[0099] In addition to helping guide the vascular catheter 22 in the blood vessel before advancing the catheter, the guide device 10 can also be used for "rescue" such operations, in which a snagging or spasm is encountered and the passage of the vascular catheter 22 along the guidewire in the blood vessel may have become obstructed and may inhibit or prevent further advancement of the vascular catheter 22. In this case, the guide device 10 can be advanced along the guidewire and through the hole of the vascular catheter 22 so that the tapered component 12 protrudes from the distal end 22b of the vascular catheter 22. The tapered component 12 can then dilate the blood vessel to facilitate the advancement of the vascular catheter 22 in the blood vessel and / or alleviate the pain and discomfort experienced by the patient associated therewith. In addition, the guide device according to certain embodiments of the present invention can be used via a sheath or without a sheath, because the device can be used as an introducer for guiding the catheter, and the combination can be referred to as a sheathless catheter and can be universal because it can be used with catheters and guidewires from any manufacturer.

[0100] In certain preferred embodiments, the tapered component 12 can have a low friction outer surface. The low friction engagement with the vessel wall facilitates a smoother travel of the tapered component in the vessel. In certain embodiments, any smooth 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, depressions, or other surface features that can impart hydrophilic properties to the tapered component 12).

[0101] The tapered member 12 may be made of any suitable material. In some embodiments, the tapered member 12 comprises a plastic material. Additionally or alternatively, the tapered member 12 may comprise an elastic material that is deformable within the blood vessel during use. The tapered member 12 may be formed of a single material.

[0102] In some embodiments, the tapered pusher 14 has an axial length of up to 30 cm. In some embodiments, the tapered pusher 14 can have an axial length between 1 cm and 30 cm, or between 14 cm and 25 cm. In some embodiments, the tapered pusher 14 has an axial length of about 14 cm. The tapered pusher 14 can have any axial length suitable for providing the desired flexibility therefor.

[0103] When the guide device 10 is used with a 6F catheter, the tapered component 12 may have an axial length of 14 cm, wherein the cylindrical first section 15 has an axial length of 10 cm and an axial length of 4 cm between the distal end 12 b of the tapered component and the cylindrical first section 15. The second section 17 may be a convex cone, wherein the cone shape of the cone conforms to an arc of a circle having a radius between 2000 mm and 4000 mm. Additionally or alternatively, the third section 19 may be a concave cone, wherein the cone shape of the cone conforms to an arc of a circle having a radius between 2000 mm and 4000 mm.

[0104] In some embodiments, the maximum diameter of the tapered component 12 (e.g., in an uncompressed state) is less 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, for an 8F catheter, the maximum diameter can be less than 2.29 mm, for a 7F catheter, the maximum diameter can be less than 2.0 mm, or for a 6F catheter, the maximum diameter can be less than 1.7 mm. The skilled reader will understand that in this context, "F" refers to the French metering system, where 1F equals a diameter of 1.3 mm.

[0105] To be compatible with a range of guidewires, in some embodiments, the size of the orifices 13 and 29 can be designed to allow a guidewire having a diameter between about 0.5 mm and 1 mm (e.g., 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") to pass through. In some non-limiting embodiments, the orifice 13 can be larger than 0.36 mm (0.014") to allow the tapered member 12 to pass over a guidewire having a diameter of 0.36 mm (0.014") (e.g., an angioplasty guidewire).

[0106] The guide device 10 can be dimensionally compatible with a range of known vascular catheters 22 and / or guidewires and is further suitable for use with a range of known vascular catheters and / or guidewires. Preferably, a single-sized guide device 10 can be used with a range of vascular catheters 22 of different lengths. In order to be dimensionally compatible with a particular vascular catheter 22, the pusher 14 must extend rearwardly beyond the proximal end of the vascular catheter 22 when the tapered member 12 is in a position in which it protrudes from the distal end 22b of the vascular catheter 22. In some embodiments, the pusher 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 member 12. In some embodiments, the pusher 14 can be provided with one or more markings 16 (see FIG. 1 ) for indicating the deployed length of the guide device 10. Figure 1A ). For example, once a particular marker 16 is proximal to the proximal end of the vascular catheter 22, the length that the guide device 10 (and therefore the vascular catheter 22) has been deployed can be deduced from the marker 16. In certain non-limiting embodiments, the markers may include visual markers and / or non-visual markers, such as radiopaque markers (e.g., tungsten or barium). In certain embodiments, one or more markers may be disposed at any suitable location on the guide device 10, not limited to the pusher 14. A radiopaque marker approximately 2 mm from the distal tip may indicate the location of the distal end of the device under fluoroscopic screening.

[0107] The invention is defined in the appended claims. For the avoidance of doubt, the invention is not necessarily limited to the specific features and dimensions discussed above. The skilled reader will also appreciate that the features (and dimensions) discussed above are not exhaustive, and embodiments of the invention having different features and / or dimensions may be implemented.

[0108] Throughout the specification and claims, the words "comprise" and "contain" and their variations mean "including but not limited to", and they are not intended to (and do not) exclude other parts, additives, components, integral bodies or steps. Throughout the specification and claims, the singular encompasses the plural unless the context requires otherwise. In particular, when the indefinite article is used, the specification should be understood to contemplate the plural as well as the singular unless the context requires otherwise. The word "component" is not limited to integral features and, in certain embodiments, may refer to a multi-piece device.

[0109] Features, entities, characteristics, compounds, chemical moieties or groups described in conjunction with a specific aspect, embodiment or example of the invention should be understood to be applicable to any other aspect, embodiment or example described herein, unless incompatible therewith. All features disclosed in this specification (including any attached claims, abstracts and drawings), and / or all steps of any disclosed method or process may be combined in any combination, except where at least some of such features and / or steps are mutually exclusive combinations. The invention is not limited to the details of any foregoing embodiments. The invention extends to any novel combination of any novel features of the features disclosed in this specification (including any attached claims, abstracts and drawings), or to any novel combination of any novel steps of any such disclosed method or process steps.

[0110] The reader's attention is directed to all papers and documents filed concurrently with or prior to the specification incorporating this application and which are open to public inspection with this specification, and the contents of all such papers and documents are incorporated herein by reference.

Claims

1. A guiding device for inserting a vascular catheter over a guide wire, the guiding device comprising: a tapered member for passing through the bore of the vascular catheter and extending from the distal end of the vascular catheter, having an aperture through which the guide wire can pass, so that the tapered member can move along the guide wire; as well as a pusher extending from the tapered member and configured to extend beyond a proximal end of the vascular catheter; Wherein, the conical component comprises a first section, a second section and a third section; the first section is arranged between the proximal end of the conical component and the second section; the second section is arranged between the first section and the third section; and the third section is arranged between the second section and the distal end of the conical component; wherein the first section is a cylinder, 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; and The diameter of the tapered component decreases from a maximum diameter at its proximal end to a minimum diameter at its distal end in a direction from its proximal end to its distal end.

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

3. The guiding device according to claim 1 or 2, wherein: The third section is a concave cone section.

4. The guiding device according to claim 1 or 2, wherein: The proximal end of the first section coincides with the proximal end of the tapered component, and wherein the diameter of the first section is the maximum diameter of the tapered component.

5. The guiding device according to claim 1 or 2, wherein: The distal end of the third section coincides with the distal end of the tapered component, and wherein the smallest diameter of the tapered component coincides with the distal end of the third section.

6. The guiding device according to claim 1, wherein: Movement of the tapered member along the guidewire from outside the proximal end of the vascular catheter to the proximal side is controllable by movement of the urging device.

7. A guiding device according to claim 6, comprising a connector connectable to the urging means for releasably connecting the guiding device to the proximal end of the vascular catheter.

8. The guiding device according to claim 7, wherein: The connector includes a lost motion mechanism configured to allow the connector to be connected to the proximal end of the vascular catheter without causing rotation of the urging device.

9. The guiding device according to claim 8, wherein: The connector includes a body connectable to the pushing device and an idler ring for connecting to the conduit.

10. The guiding device according to claim 9, wherein: The idler ring is axially constrained relative to the body of the connector and is freely rotatable about the body of the connector.

11. A guide device according to claim 10, comprising a rim to limit the idler ring in a distal direction relative to the body of the connector.

12. A guiding device according to any one of claims 7 to 11, wherein: The connector is movable along the pushing device.

13. A guiding device according to any one of claims 6 to 11, wherein: The pusher has a non-circular cross-section.

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

15. The guiding device according to claim 14, wherein: Adjacent edges have different lengths.

16. The guiding device according to claim 14, wherein: Corners between adjacent edges are rounded.

17. The guiding device according to claim 14, wherein: The plurality of edges includes a first curved edge.

18. The guiding device according to claim 17, wherein: The first curved edge conforms to a portion of a perimeter of an outer surface of the proximal end of the tapered component.

19. The guide device of claim 14, comprising an inner bore accessible through the aperture.

20. The guiding device according to claim 19, wherein The plurality of sides includes a second curved side that conforms to a portion of a perimeter of the inner bore of the tapered component.

21. The guiding device according to claim 1 or 2, wherein: The urging device is arranged to allow a portion of the guidewire radially adjacent the urging device to remain visible to an operator during use.

22. A kit comprising: A guiding device according to any one of claims 1 to 21; as well as Vascular catheters; Wherein, the tapered component of the guiding device is configured to pass through the bore of the vascular catheter and extend from the distal end of the vascular catheter.

23. A kit comprising: A guiding device according to any one of claims 1 to 21; Guidewire; The opening of the tapered component can allow the guide wire to pass therethrough, so that the tapered component can move along the guide wire.

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