CATHETER, CATHETER HANDLE, AND METHOD FOR GUIDING CATHETER

JP2025510116A5Pending Publication Date: 2026-03-06エムエスエイチ イノベーションズ アーベー +2
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Patent Information

Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Filing Date
2023-03-23
Publication Date
2026-03-06

AI Technical Summary

Technical Problem

Existing minimally invasive surgical techniques for cardiac procedures often cause discomfort and trauma to patients, and there is a need for improved methods and systems to further minimize these issues.

Method used

A catheter system with a flexible cylindrical hollow tube at its distal end, featuring a pull wire and notches on its sides, allowing for radial access and reduced patient discomfort. The system includes a handle with a pull wire control unit and a guard wire to maintain the pull wire's position, enabling precise catheter manipulation.

Benefits of technology

The catheter system allows for smaller dimensions while maintaining torque and strength, enabling radial access that reduces patient discomfort compared to traditional open heart surgery and some minimally invasive techniques. It facilitates precise navigation through coronary vessels or abdominal organs, enhancing the efficacy of cardiac procedures.

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Abstract

A delivery and sampling catheter (1) comprises a flexible cylindrical hollow tube (2) at its distal end, the flexible tube (2) having two opposing ends (3, 4), a first side (5) extending between the two opposing ends (3, 4) and a second side (6) opposite the first side (5), the first side (5) having a number of notches (7) along at least a portion of its length, a pull wire (8) disposed along the first side (5) of the flexible tube (2) at its distal-most end (3), the second side (6) having a number of notches (9) along its length corresponding to the first side (5), the notches (7) on the first side being wider than the notches (9) on the second side (6), and the pull wire (8) disposed external to the flexible tube (2).
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Description

[Technical field]

[0001] The present invention relates to a delivery and sampling catheter comprising a flexible cylindrical hollow tube at its distal end, the flexible tube having two opposing ends and a first side and a second side opposite the first side extending between the two opposing ends, the first side having a plurality of notches along at least a portion of its length, and a pull wire disposed on the first side at the distal-most end of the flexible tube.

[0002] The present invention further relates to a catheter handle having a distal end and a proximal end, the handle comprising an elongate housing extending between the proximal and distal ends, the housing having an opening at the distal end adapted to allow a single pull wire for a unidirectional catheter to pass therethrough, a retention device disposed along and inside the housing and adapted to be secured to the pull wire, the handle further comprising a pull wire control adapted to be accessible outside the housing and connected to the retention device via a side opening in the housing.

[0003] Additionally, the present invention further relates to methods for guiding a catheter through coronary vessels or abdominal organs to an endocardial site, a pulmonary site, or an epicardial site. [Background technology]

[0004] Traditionally, cardiac surgery is an open-heart procedure performed under general anesthesia, during which the heart is stopped and blood flow is controlled by a cardiopulmonary bypass machine. Traditional open-heart surgery causes significant trauma and discomfort to the patient and exposes the patient to several potential risks, such as infection, stroke, kidney failure, and adverse effects associated with the use of a heart-lung machine.

[0005] Due to the shortcomings of open-heart surgery, there has been growing interest in minimally invasive procedures. In percutaneous transcatheter (or transluminal) techniques, a catheter can be advanced, for example, through an opening in the femoral artery and through the descending aorta to the heart, where a prosthesis, for example, is deployed in the annulus of the valve to be repaired (e.g., the aortic annulus).

[0006] U.S. Patent Application Publication No. 2007 / 0260225A1 discloses a driver for a steerable sheath that provides some or all of the following features: one-handed operation, ergonomic and comfortable use, precision in positioning the tip of the sheath, a positive locking mechanism to maintain the position of the tip of the sheath, and a fixation device for securing the driver to a surgical drape or other object.

[0007] US 2018 / 0028779 A1 discloses an intravascular device delivery system having an elongate member with a flexible hypotube that may be rotationally keyed to a steerable catheter. The flexible hypotube includes one or more cuts to allow the flexible hypotube to bend in a first plane. The steerable catheter is steerable to bend the flexible hypotube in the first plane and is longitudinally movable relative to the flexible hypotube to allow distal movement of the steerable catheter relative to a distal end of the flexible hypotube.

[0008] US 2018 / 0055636A1 discloses a method of delivering a rigid intravascular device to a target location within a patient's heart, the method including positioning a distal tip of an elongated member of an intravascular device delivery system within the right atrium of the heart and moving the distal tip of the elongated member into the left atrium of the heart. The method includes advancing an inner steerable catheter of the elongated member distally longitudinally a first longitudinal distance relative to an outer sleeve of the elongated member, bending at least a portion of the inner steerable catheter a first bending amount, then advancing the inner steerable catheter of the elongated member distally longitudinally a second longitudinal distance relative to the outer sleeve of the elongated member, and then bending at least a portion of the inner steerable catheter a second bending amount.

[0009] Thus, while prior art solutions allow for some aspects of minimizing the problem, there remains a need for improved methods and systems for further minimizing patient trauma and discomfort following catheter use. 〔summary〕

[0010] It is therefore an object of the present invention to provide systems and methods that further reduce the challenges of minimally invasive surgery.

[0011] According to a first aspect of the present disclosure, a delivery and sampling catheter is provided comprising a flexible cylindrical hollow tube at its distal end. The flexible tube has two opposing ends and a first side and a second side opposite the first side extending between the two opposing ends. The first side has a number of notches along at least a portion of its length, and a pull wire is disposed along the first side of the flexible tube at the most distal end. The second side has a number of notches along a length corresponding to the first side, the number of notches on the first side being wider than the number of notches on the second side, and the pull wire is disposed outside the flexible tube. Such a catheter provides the possibility of reaching the heart via radial access or cubital vein. Accessing the heart via cubital vein or radial access reduces patient discomfort compared to open heart surgery, but also compared to minimally invasive surgery via femoral artery or jugular vein. By using this single-sided catheter, it is possible to make the catheter size small enough, thereby opening up the possibility of entering via radial access or cubital vein. The specific design of the dilator, which extends over a 0.014 inch (0.3556 mm) or 0.035 inch (0.889 mm) guidewire, allows the device to be used without an introducer. When the aorta or vena cava is reached, the pre-inserted dilator is withdrawn.

[0012] Furthermore, the present invention also relates to an integrated introducer and actively bendable guide catheter for delivery and sampling, comprising a flexible cylindrical hollow tube at its distal end, in accordance with the above disclosure.

[0013] The specific design of the flexible tube, which is bendable in only one direction, allows the catheter to be manufactured in smaller dimensions, only about 3 French, while still maintaining torque generating capability and sufficient strength.

[0014] According to another aspect of the present disclosure, the plurality of cutouts in the first side have a V-shape.

[0015] According to yet another embodiment of the present disclosure, the plurality of cutouts on the first side surface have a V-shape with a flat top.

[0016] To increase the strength of the catheter, according to yet another aspect of the present disclosure, all angles in the notches have a radius, and by reducing the size, the radiused notches have been shown to be beneficial to the strength of the flexible tubing.

[0017] According to yet another aspect of the present disclosure, a distance between centers of the plurality of cutouts on the first side is equal to a distance between centers of the plurality of cutouts on the second side.

[0018] According to yet another aspect of the disclosure, the notches on the first side face the notches on the second side. In a preferred embodiment, the notches on the first side face directly against corresponding notches on the second side, so that, even though the flexible tube is formed from a single block of material, portions of the flexible tube between each pair of notches on the first and second sides act as hinges. Thus, as less tube material remains between the notches on the first and second sides, the tube becomes more flexible. However, the strength of the flexible tube decreases with increased flexibility (or with less material holding the tube together).

[0019] In accordance with a preferred aspect of the present disclosure, at least one guard wire is disposed on the catheter to hold the pull wire adjacent the flexible tube and prevent, or at least limit, the pull wire from escaping from a bend in the distal portion of the catheter.

[0020] According to another aspect of the present disclosure, the guard wires are circumferentially disposed about the flexible tube.

[0021] According to yet another aspect of the present disclosure, one end of the guard wire is attached to the distal end of the flexible tube and the other end of the guard wire is attached to the proximal end of the catheter or the proximal end of the flexible tube, the guard wire being coiled around the flexible tube between the distal end of the flexible tube and the proximal end of the catheter or the proximal end of the flexible tube. Depending on the length of the flexible tube, the coiled guard wire may be attached to the flexible tube at at least one other point between the proximal and distal ends of the flexible tube. The at least one additional attachment point is formed on a second side of the flexible tube, according to one embodiment.

[0022] According to yet another aspect of the present disclosure, a flexible sheath is disposed over the flexible tube containing the pull wire, which may be advantageous, for example, to minimize the risk of notches in the pull wire or flexible tube damaging veins or tissue as the catheter is navigated through the patient.

[0023] According to a further aspect of the present disclosure, the outer diameter of the hollow tube is greater than 1.3 mm and less than 2.1 mm. This interval covers catheter diameters from 4 French to 6 French (1 French = 1 / 3 mm). The length of the catheter is preferably at least 100 cm, and at most 130 cm, and more preferably 110 cm to 120 cm.

[0024] According to yet another aspect of the present disclosure, the distal end of the flexible tube is provided with a tracking device. This tracking device may be, for example, an RF coil or a specific substance detectable by MRI (Magnetic Resource Imaging). Furthermore, the overall shape and orientation of the flexible tube of the catheter is preferably detectable as well. Thus, according to yet another aspect, the flexible tube is provided with a tracking function, for example, an RF coil or a coating containing a contrast agent such as gadolinium or iodine.

[0025] It is yet another object of the present disclosure to provide a handle that facilitates the use of a unilateral catheter.

[0026] Thus, according to one aspect of the disclosure, there is provided a catheter handle having a distal end and a proximal end, the handle comprising an elongate housing extending between the proximal and distal ends, the housing having an opening at the distal end configured to allow a single pull wire for a unidirectional catheter to pass therethrough, a retention device slidably disposed along and inside the housing and configured to be secured to the pull wire, the handle further comprising a pull wire control configured to be accessible outside the housing and connected to the retention device via a side opening in the housing, the pull wire control being movable between a distal position in which the pull wire connected to the retention device is in a relaxed state when in use and connected to the pull wire, and a proximal position in which the pull wire is in a taut state such that the unidirectional catheter is in a bent state, the pull wire control being circumferentially disposed around the distal end of the housing.

[0027] According to yet another aspect of the present disclosure, the pull wire control is rotatably configured to be rotated between an unlocked state and a locked state, and in the unlocked state, the pull wire control is movable along the housing between a distal position and a proximal position and configured to respectively extend or bend the catheter when connected to a pull wire.

[0028] According to yet another aspect of the present disclosure, the retaining device is configured to be rotatable with the pull wire control between an unlocked state and a locked state, and the retaining device has at least one peripheral extension disposed in one of several recesses disposed on the inside of the housing in the locked state.

[0029] According to another aspect of the disclosure, the handle includes a spring, one end of the spring being disposed within the housing and the other end being disposed on the retaining device such that the retaining device is biased into a locked state.

[0030] To improve the stability of the pull wire control, according to yet another aspect of the present disclosure, a guide tube is aligned with the housing at the distal opening, and a pull wire control is circumferentially slidably disposed around the guide tube at its distal end.

[0031] According to another aspect of the present disclosure, a method is provided for guiding a unilateral catheter through a coronary vessel or abdominal organ to an endocardial, pulmonary, or epicardial site. The method can be used to reach the lung or abdominal organ. The method includes the steps of advancing a catheter toward a desired site through a radial access opening, a femoral artery, a vein, or an opening in an cubital vein, pulling a pull wire of the catheter until a bend in the distal end of the catheter is detectable when the distal end of the catheter reaches a curve or bifurcation of the vessel, rotating the catheter by rotating the handle of the catheter to align the radial orientation of the bend in the distal end of the catheter to match the radial orientation of the curve or bifurcation of the vessel, pulling the pull wire by manually manipulating the handle of the catheter until the radius of the bend in the distal end of the catheter matches the radius of the curve or bifurcation of the vessel, and pushing the handle to advance the catheter through the curve or bifurcation.

[0032] According to one aspect of the above method, the method further includes releasing the pull wire to extend the distal end of the catheter.

[0033] Preferably, the method includes using a catheter as disclosed above.

[0034] Also preferably, the method includes using a handle as disclosed above.

[0035] According to one aspect of the present disclosure, there is provided a medical method of accessing a site within or at a cardiac site of a patient via the patient's vasculature from the radial or cubital vessels, including the methods for navigating the heart disclosed hereinabove.

[0036] It is emphasized that as used in this specification, the term "comprises / comprising" is used to specify the presence of stated features, integers, steps or components, but does not exclude the presence or addition of one or more other features, integers, steps, components or groups thereof.

[0037] Further features and advantages of the present invention will become apparent from a study of the appended claims and the following description. Those skilled in the art will appreciate that different features of the present invention may be combined to create embodiments other than those described below without departing from the scope of the present invention. [Brief description of the drawings]

[0038] The above and other objects, features and advantages of the present invention will be better understood through the following illustrative and non-limiting detailed description of exemplary embodiments thereof.

[0039] [Figure 1] FIG. 1 is a perspective view of one embodiment of a catheter according to the present disclosure.

[0040] [Diagram 2] FIG. 2 is a perspective view of an embodiment of the catheter of FIG. 1 without a flexible sheath.

[0041] [Diagram 3] 3 is an enlarged portion of the distal end of the catheter of FIG. 2.

[0042] [Figure 4] FIG. 4 is a side view of the distal end of the catheter of FIG. 3.

[0043] [Diagram 5]FIG. 4 is an exploded view of a distal portion of the catheter of FIG. 3.

[0044] [Figure 6] FIG. 1 is a side view of a portion of a flexible tube in a catheter according to an embodiment of the present disclosure.

[0045] [Figure 7] FIG. 7 is an enlarged view of a portion of the flexible tube of FIG. 6.

[0046] [Figure 8] FIG. 2 is a perspective view of a handle according to one embodiment of the present disclosure.

[0047] [Figure 9] FIG. 9 is a partial cross-sectional view of the handle of FIG. 8.

[0048] [Figure 10] FIG. 10 is an enlarged view of a portion of FIG.

[0049] [Figure 11] FIG. 2 is a partial cross-sectional view of a handle according to one embodiment of the present disclosure.

[0050] [Figure 12] FIG. 2 is a side view of the distal end of the catheter in a bent state.

[0051] [Figure 13] FIG. 1 is a perspective view of a catheter having multiple dilution holes. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0052] The present invention will now be described in more detail with reference to the accompanying drawings, which show exemplary embodiments of the invention. However, the present invention may be embodied in many different forms and should not be construed as being limited to the embodiments set forth herein, but rather, these embodiments are provided for completeness and completeness. Throughout the description, like reference numerals refer to like elements.

[0053] 1 and 2, there is illustrated a catheter 1. Figure 1 shows a flexible sheath 11 disposed over a flexible tube and surrounding a pull wire 8.

[0054] 3, 4 and 5, the catheter 1 comprises a flexible cylindrical hollow tube 2 at its distal end having two opposing ends 3, 4 and a first side 5 and a second side 6 opposite the first side 5 extending between the two opposing ends 3, 4. The first side 5 has a number of notches 7 along at least a portion of its length, and a pull wire 8 is disposed along the first side 5 of the flexible tube 2 at the most distal end 3. Furthermore, the second side 6 has a number of notches 9 along its length corresponding to the first side 5, the number of notches 7 on the first side being wider than the number of notches 9 on the second side 6. Furthermore, the pull wire 8 is disposed on the outside or exterior of the flexible tube 2, which is part of what allows for these relatively small dimensions compared to the prior art.

[0055] The notches 7 in the first side 5 are V-shaped, with the V-shape having a flat top that is somewhat truncated. Furthermore, as can be seen more clearly in Figures 6 and 7, all angles of the notches have a radius to improve the strength of the hollow flexible tube to withstand repeated bending.

[0056] The distance between the centers of the multiple notches 7 on the first side 5 is equal to the distance between the multiple notches 9 on the second side 6, and the multiple notches 7 on the first side 5 are positioned directly opposite the multiple notches on the second side 6.

[0057] A guard wire 10 is positioned on the catheter 1 to hold the pull wire 8 adjacent the flexible tube. The guard wire 10 is positioned circumferentially around the flexible tube 2.

[0058] Furthermore, one end of the guard wire 10 is attached to the distal end 3 of the flexible tube, and the other end of the guard wire 10 is attached to the proximal end of the catheter, and the guard wire 10 is coiled around the flexible tube 2 between the distal end 3 of the flexible tube 2 and the proximal end of the catheter 1.

[0059] The guard wire 10 protects the flexible sheath 11 when the flexible tube 2 is bent by pulling the pull wire 8 and prevents the pull wire 8 from penetrating the flexible sheath, thereby providing better strength without increasing the size of the catheter.

[0060] Referring to FIG. 8, one embodiment of the handle 21 is illustrated. As seen in FIG. 9, the catheter handle 21 has a distal end 22 and a proximal end 23. The handle 21 comprises an elongated housing 24 extending between the proximal end 23 and the distal end 22. The housing 24 has an opening 25 at the distal end 22 configured to allow one pull wire 8 for the unidirectional catheter 1 to pass therethrough. A retainer 26 is slidably disposed along and inside the housing 24 and configured to be secured to the pull wire 8. The handle 21 further comprises a pull wire control 27 configured to be accessible outside the housing 24 and connected to the retainer 26 via a side opening 28 (see FIG. 1) within the housing 24. The pull wire control 27 is movable between a distal position in which, when in use and connected to the pull wire 8, the pull wire 8 connected to the retainer 26 is in a relaxed state as shown in FIG. 9, and a proximal position in which the pull wire 8 is in a taut state such that the unidirectional catheter 1 is in a bent state. Pull wire control 27 is disposed circumferentially around distal end 22 of housing 24 .

[0061] The pull wire control 27 is rotatable such that it can be rotated between an unlocked state and a locked state. In the unlocked state, the pull wire control 27 is movable along the housing 24 to extend or bend the catheter 1 between a distal position and a proximal position, respectively.

[0062] As further shown in Figures 9 to 11, the retaining device 26 is configured to be rotatable between an unlocked state and a locked state together with the pull wire control 27, and the retaining device 26 has a peripheral extension 29 that can be positioned in one of several recesses 30 located on the inside of the housing 24.

[0063] Furthermore, the handle 21 is provided with a spring 31, one end of which is disposed within the housing 24 and the other end of which is disposed on the retaining device 26 so that the retaining device 26 is biased into a locked state.

[0064] A guide tube 32 is disposed in alignment with the housing 24 at the distal opening 25 thereof, and a pullwire control 27 is slidably disposed circumferentially about the guide tube 32 at its distal end 22 .

[0065] Also shown in Figures 9-11 is a protrusion 33 that is disposed on the retaining device 26 for connecting with a corresponding recess (not shown) on the inside of the pull wire control section 27 and thereby establishing a connection between the pull wire control section 27 and the retaining device 26.

[0066] As shown in FIGS. 1-7, a method for guiding a unilateral catheter to a desired site, such as an endocardial site, a lung, or an abdominal organ, includes the steps of advancing the catheter 1 toward the desired site through a radial access opening or an opening punctured in an antecubital vein; when the distal end 3 of the catheter 1 reaches a curved or bifurcated portion of a blood vessel, pulling the pull wire 8 of the catheter 1 until the bend in the distal end 3 of the catheter 1 becomes detectable; rotating the catheter 1 by rotating the handle 21 of the catheter 1 as shown in FIGS. 8-11 to align the radial orientation of the bend in the distal end 3 of the catheter 1 to match the radial orientation of the curved or bifurcated portion of the blood vessel; pulling the pull wire 8 by manually manipulating the handle 21 of the catheter 1 until the radius of the bend in the distal end 3 of the catheter 1 matches the radius of the curved or bifurcated portion of the blood vessel; and pushing the handle 21 to advance the catheter 1 through the curved or bifurcated portion.

[0067] 12 shows the catheter 1 when the pull wire 8 is "pulled", i.e., when the distal portion of the catheter or flexible tube 2 is bent. The notches 7 on the first side 5 narrow when the catheter 1 is in a bent state, while the notches 9 on the second side 6 become slightly wider.

[0068] When the pull wire 8 is pulled, the flexible tube 2 bends with the pull wire 8 inside the bent portion because the pull wire 8 is located on the first side 5 of the flexible tube 2, where the notches 7 are larger than the notches 9 on the second side 6. This biases the flexible tube to bend toward the side where the pull wire 8 is located. The catheter is covered by a flexible sheath (11 in FIG. 1), and a guard wire 10 is coiled around the flexible tube 2 to prevent the sheath from being torn or cut by the pull wire 8, so that the guard wire 10 keeps the pull wire 8 close to the flexible tube 2 when the catheter is in a bent state. By having the guard wire, the thickness of the flexible sheath can be kept to a minimum, and therefore the dimensions of the catheter 1 can be reduced.

[0069] After the bend or bifurcation, the pull wire 8 is released, allowing the distal end 3 of the catheter 1 to extend.

[0070] A further feature of the catheter 1 is that it has multiple dilution holes 34 on the side at the distal end of the catheter so that the contrast agent can be released. Figure 13 shows an example of such multiple holes 34. Preferably, the holes 34 are not located on the outer curve of the bendable portion of the catheter 1 so as to avoid protrusion of small devices delivered through the catheter.

[0071] The medical methods of the present disclosure for accessing a site within or at the heart of a patient via the patient's vasculature from the radial or cubital vessels include the methods described above for navigating to the heart.

[0072] As used herein, the singular forms "a," "an," and "the" include the plural unless otherwise indicated. It is further understood that as used herein, the terms "comprise," "comprises," "including," and / or "comprising" specify the presence of stated features, integers, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof. When an element is described as "connected" or "coupled" to another element, it will be understood that the element may be directly connected or coupled to the other element or that there may be intervening elements.

[0073] Unless otherwise specified, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by those skilled in the art to which the present invention belongs. Furthermore, terms as defined in commonly used dictionaries should be interpreted as having a meaning consistent with their meaning in the context of the relevant art, and will not be interpreted in an idealized or overly formal sense unless expressly defined in this specification.

[0074] Although several embodiments of the present invention are described and illustrated herein, those skilled in the art will readily envision various other means and / or structures for performing the functions and / or results and / or obtaining one or more advantages described herein. Each such variation and / or modification is deemed to be within the scope of the present invention. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary, and that the actual parameters, dimensions, materials, and / or configurations will depend on the particular application or applications in which the teachings of the present invention are used.

Claims

1. 1. A delivery and sampling catheter (1) comprising a flexible cylindrical hollow tube (2) at its distal end, the flexible tube (2) having two opposing ends (3, 4), a first side (5) extending between the two opposing ends (3, 4), and a second side (6) opposite the first side (5), the first side (5) having a plurality of notches (7) along at least a portion of its length, and a pull wire (8) disposed along the first side (5) of the flexible tube (2) at its distal-most end (3), the second side (6) has a plurality of notches (9) along its length corresponding to said first side (5); The plurality of notches (7) on the first side surface are wider than the plurality of notches (9) on the second side surface (6), The pull wire (8) is disposed outside the flexible tube (2), At least one guard wire (10) is disposed on the catheter (1) to hold the pull wire (8) adjacent the flexible tube. Catheter (1).

2. The plurality of notches (7) on the first side have a V-shape. A catheter (1) according to claim 1.

3. The plurality of notches (7) on the first side surface have a V-shape with a flat top. A catheter (1) according to claim 1.

4. all angles in the plurality of cutouts have a radius; A catheter (1) according to any one of claims 1 to 3.

5. The distance between the centers of the notches (7) on the first side (5) is equal to the distance between the centers of the notches (9) on the second side (6); A catheter (1) according to claim 1.

6. The plurality of notches (7) on the first side surface (5) face the plurality of notches (9) on the second side surface (6). A catheter (1) according to claim 1.

7. The guard wire (10) is arranged circumferentially around the flexible tube (2). A catheter (1) according to claim 1.

8. One end of the guard wire (10) is attached to the distal end (3) of the flexible tube, and the other end of the guard wire (10) is attached to the proximal end of the catheter; The guard wire (10) is coiled around the flexible tube (2) between the distal end (3) of the flexible tube (2) and the proximal end of the catheter (1) or the proximal end of the flexible tube (2). A catheter (1) according to claim 1.

9. The outer diameter of the hollow tube (2) is greater than 1.3 mm and less than 2.1 mm. A catheter (1) according to claim 1.

10. a catheter handle (21) having a distal end (22) and a proximal end (23), the handle (21) comprising an elongated housing (24) extending between the proximal end (23) and the distal end (22); The housing (24) has an opening (25) at the distal end (22) configured to allow one pull wire (8) for a unidirectional catheter (1) to pass therethrough; a retainer (26) slidably disposed along and inside the housing (24) and configured to be secured to the pull wire (8); The handle (21) further comprises a pull wire control (27) configured to be accessible outside the housing (24) and to be connected to the retaining device (26) through a side opening (28) of the housing (24); the pull wire control (27) is movable between a distal position in which, when in use and connected to the pull wire (8), the pull wire (8) connected to the retention device (26) is in a relaxed state, and a proximal position in which the pull wire (8) is in a taut state so that the unidirectional catheter (1) is in a bent state; The pull wire control (27) is circumferentially disposed around the distal end (22) of the housing (24). A catheter (1) according to claim 1.

11. The pull wire control portion (27) is configured to be rotatable so that it can be rotated between an unlocked state and a locked state, In a released state, the pull wire control (27) is movable along the housing (24) between the distal and proximal positions and is configured to respectively extend or bend the catheter (1) when connected to a pull wire (8). A catheter (1) according to claim 10.

12. The retaining device (26) is configured to be rotatable together with the pull wire control (27) between an unlocked state and a locked state, and the retaining device (26) has at least one peripheral extension (29) disposed in one of several recesses (30) disposed inside the housing (24) in the locked state. A catheter (1) according to claim 10 or 11.

13. The handle (21) is provided with a spring (31), One end of the spring (31) is disposed within the housing (24) and the other end is disposed on the retaining device (26) so that the retaining device (26) is biased to a locked state. A catheter (1) according to claim 12.

14. a guide tube (32) aligned with the housing (24) at the distal opening (25) of said housing (24); a pull wire control (27) slidably disposed circumferentially around the guide tube (32) at its distal end (22); A catheter (1) according to claim 10.