Echogenic guidewire

Abstract

A guidewire is disclosed for use in procedures requiring axillary access and enhanced echogenicity. The guidewire may include a proximal portion and a distal portion. The distal portion may include a tapered core wire extending from the proximal portion to the distal tip. The distal portion may have surface texturing on at least one surface near the distal end of the distal portion. The guidewire may have, for example, a 180° J-tip operably connected to the tapered core wire. At least a portion of the J-tip may have a stiffness lower than that of the tapered core wire. The J-tip may include a metal-filled polymer such as tungsten-filled polyurethane. The tapered core wire may have a maximum diameter of 0.6–0.7 mm and a taper length of 70–120 mm.

Description

Technical Field

[0001] [Cross - Reference to Related Applications] This application claims priority to U.S. Provisional Patent Application No. 63 / 529,856, filed on July 31, 2023, the content of which is hereby incorporated by reference in its entirety.

[0002] [Technical Field] The present disclosure relates to guidewires for medical procedures, particularly echo - genic axillary guidewires.

Background Art

[0003] The axillary insertion of a blood pump into a patient presents unique challenges in a surgical setting. In the prior art, conventional guidewires cannot safely pass through the aortic valve, so a wire exchange procedure is required. This adds several minutes to the procedure even if everything goes smoothly on the first try. The insertion of an appropriate guidewire usually involves a significant number of pauses to monitor the position of the wire and catheter during the exchange.

[0004] Commercially available guidewires are fluorogenic due to their density. However, most surgical environments do not include fluoroscopy equipment. To use a guidewire outside a dedicated catheterization laboratory or a hybrid catheter laboratory / operating room, it is necessary to introduce a portable C - arm for fluoroscopy, which has its own problems including floor space requirements, staff requirements, etc. Commercially available guidewires can reflect ultrasound, but due to their thinness, their visibility via echocardiogram is limited. Since it is rare for a thin wire to be perfectly in the same plane as the ultrasound depth, it is difficult to clearly determine the position of the guidewire, for example, within the left ventricle.

Summary of the Invention

Means for Solving the Problems

[0006] The guidewire may have, for example, a 180°J tip operably connected to a tapered core wire. At least a portion of the 180°J tip may have a stiffness lower than that of the tapered core wire. The 180°J tip may contain a metal-filled polymer, such as tungsten-filled polyurethane. The tapered core wire may contain nitinol.

[0007] The guidewire may include a coating around at least a portion of the tapered core wire. The coating may include braided polytetrafluoroethylene (PTFE).

[0008] A tapered core wire may have a circular cross-section along its entire length. A tapered core wire may have a maximum diameter of, for example, 0.6 to 0.7 mm. A tapered core wire may have a minimum diameter of, for example, 0.1 mm to 0.2 mm. A tapered core wire may have a taper length of 70 mm to 120 mm. A guide wire may have a total length of 140 cm to 160 cm.

[0009] In various embodiments, a kit may be provided. The kit may include a guidewire as disclosed herein and may include an introducer sheath and / or a closure device.

[0010] Methods for delivering medical devices can be provided in various embodiments. These methods may include providing a guidewire, such as those disclosed herein. The method may include introducing the guidewire into the heart along a pathway through at least one blood vessel, the pathway passing through the aortic arch, and the guidewire being introduced into the heart without the use of a guide catheter. The method may also include sliding the medical device along the guidewire until the medical device is at a target location.

[0011] The accompanying drawings, incorporated herein and forming part thereof, illustrate embodiments of the present invention and, together with the above general description of the invention and the following detailed description of embodiments, are useful in illustrating the principles of the present invention. [Brief explanation of the drawing]

[0012] [Figure 1] This is a diagram showing a side view of a cut guide wire. [Figure 2A] This figure shows side views of various distal tip extensions. [Figure 2B] This figure shows side views of various distal tip extensions. [Figure 2C] This figure shows side views of various distal tip extensions. [Figure 3A] This is a diagram showing a cross-section of a groove. [Figure 3B] This is a diagram showing a cross-section of a groove. [Figure 4] This is a diagram of a guidewire positioned inside the heart. [Figure 5] This is a diagram showing a side view of a cut guide wire.

[0013] It should be understood that the attached drawings are not necessarily to a fixed scale and present a somewhat simplified representation of various features illustrating the fundamental principles of the present invention. For example, specific design features of a series of operations as disclosed herein, including the specific dimensions, orientation, location, and shape of various exemplary components, are partially determined by the specific intended use and operating environment. Certain features of the illustrated embodiments are enlarged or distorted relative to other features to facilitate visualization and clear understanding. In particular, thin features may be thickened, for example, for clarity or explanation. [Modes for carrying out the invention]

[0014] The following description and drawings are merely illustrative of the principles of the present invention. Therefore, it will be understood that various configurations embodying and falling within the scope of the principles of the present invention can be devised by those skilled in the art, even if not expressly described or illustrated herein. Furthermore, all embodiments described herein are clearly and primarily intended for illustrative purposes only, to help the reader understand the principles and concepts of the invention to which the inventors have contributed to advance the art, and are not limited to such specifically described embodiments and conditions. Furthermore, the term "or" as used herein means non-exclusive unless otherwise indicated (e.g., "or else" or "or in another way"). Also, the various embodiments described herein are not necessarily mutually exclusive, as some embodiments may be combined with one or more other embodiments to form new embodiments.

[0015] Many of the innovative teachings in this application are described with particular reference to currently preferred exemplary embodiments. However, it should be understood that these types of embodiments provide only a few examples of the many advantageous uses of the innovative teachings herein. In general, the descriptions contained herein are not necessarily limited to any of the various claimed inventions. Furthermore, some descriptions may apply to some inventive features but not to others. Those familiar with the art and who draw information from the teachings herein will recognize that the invention is applicable to a variety of other arts or embodiments.

[0016] In various embodiments, guidewires for delivering catheter-based devices having a distal end or a surface near it that has been treated to enhance echogenicity may be provided. Surface texturing through chemical, electrochemical, or mechanical processes improves ultrasound reflection, making the area of ​​the wire more echogenic and more visible on echocardiography, as it is examined by a needle used to gain access for percutaneous intervention. This facilitates determining the proper guidewire position under echocardiography without requiring fluoroscopy, as is commonly used.

[0017] As mentioned above, this solves the problem of limited guidewire visibility under echocardiography, for example, when echocardiography is used to monitor the delivery and positioning of a blood pump in the left ventricle (e.g., one of Abiomed's IMPELLA® blood pumps).

[0018] The current delivery guidewire is modeled on a conventional wire with a diameter of 0.457 mm (0.018 inches) and a length of 260 cm, designed for femoral access. Since it cannot safely pass through the aortic valve, it requires a wire exchange procedure, which adds time and complexity to the procedure (e.g., 4 - 5 minutes even if everything goes smoothly in the first attempt), and involves a significant amount of downtime to monitor the position of the wire and catheter during the exchange. Further complicating matters, the wire is often difficult to visualize via transesophageal echocardiography, the most common imaging in the operating room.

[0019] In addition to improved visibility during fluoroscopy, improved echogenicity may be desirable for better wire positioning. This is because some surgeons may not use fluoroscopy during delivery.

[0020] As can be seen in FIG. 1, the guidewire (100) may include a distal section (110) that may include a distal tip (112), an optional coiled wire (114), a core wire (116), and a transition section (118). The guidewire may include a proximal section (120) having a proximal end (122) (e.g., the proximal section of the core wire (116)).

[0021] The coiled wire (114), if used, can provide resistance to radial deformation and allow the guidewire (100) to recover its original shape even after deformations that may be encountered during placement or manipulation within the heart. The coiled wire (114) surrounds the core wire (116). Referring briefly to FIG. 5, in a preferred embodiment, the guidewire does not include a coiled wire.

[0022] Referring to FIG. 1, the core wire (116) may have a decreasing diameter from the transition section (118) to the tip (112) of the distal section. The distal section (110) may have a length L2 (198).

[0023] The core wire (116) may also include a proximal section (120) extending between the proximal end (122) and the transition section (118). In some embodiments, the proximal section (120) may have a constant diameter. In some embodiments, the diameter of the proximal section may vary. The proximal section may be generally cylindrical and have a circular cross-section. The proximal section (120) may have a length L1 (199).

[0024] In some embodiments, L2 may be 50-75% of the total length of the core wire (116). In some embodiments, L2 may be 20-60% of the total length of the core wire (116). In some embodiments, L1 may be 40-80% of the total length of the core wire (116). In some embodiments, L1 may be 25-50% of the total length of the core wire (116).

[0025] The distal section (110) of the core wire may be more flexible than the proximal section (100) of the guide wire. This allows the physician initially placing the guide wire in the patient to minimize damage to the patient's arterial system.

[0026] Referring to Figures 2A to 2C, in various embodiments, the distal tip (112) can include a distal extension. Such a distal extension can be, for example, a 180° J tip (201, Figure 2A), a 270° tip (202, Figure 2B), or a closed-loop tip (203, Figure 2C).

[0027] In various embodiments, the tip (112) can be made of a platinum alloy. In various embodiments, the tip (e.g., a tip with a distal extension) can be made non-traumatic (e.g., relatively soft and flexible). In various embodiments, the tip can be made of tungsten-filled polyurethane. The tip may have a stiffness gradient, with maximum stiffness near the core wire.

[0028] The guidewire (100) may contain nitinol. For example, the core wire (116) may contain nitinol.

[0029] At least a portion of the guidewire may include a coating. In some embodiments, the proximal section (e.g., proximal section (120)) may include a coating. In some embodiments, the core wire may include a coating. For example, as shown in Figure 5, the coating (510) may be placed around part or all of the core wire (116). The coating may be, for example, a braided polytetrafluoroethylene (PTFE) coating. The coating may be monochromatic or multicolored (e.g., two-color) coating.

[0030] A tapered core may have a circular cross-section and may not have flattened ends.

[0031] The length of the guidewire can be adjusted based on the intended delivery approach. For example, the guidewire may have a total length of 250 cm or less. The guidewire may have a total length of 225 cm or less. The guidewire may have a total length of 200 cm or less. The guidewire may have a total length of 175 cm or less. The guidewire may have a total length of 160 cm or less. The guidewire may have a length of at least 125 cm. The guidewire may have a length of at least 140 cm. The guidewire may have a total length of at least 150 cm. The guidewire may have a total length of 125 to 175 cm.

[0032] The guidewire may have a taper length L3 (197) of 150 mm or less (for example, the axial distance at which the guidewire becomes tapered). The guidewire may have a taper length of 140 mm or less. The guidewire may have a taper length of 130 mm or less. The guidewire may have a taper length of 120 mm or less. The guidewire may have a taper length of 110 mm or less. The guidewire may have a taper length of 100 mm or less. The guidewire may have a taper length of at least 70 mm. The guidewire may have a taper length of at least 80 mm. The guidewire may have a taper length of at least 90 mm. The guidewire may have a taper length of 70 to 120 mm.

[0033] The core wire may have a maximum diameter (196) of 0.8 mm or less. The core wire may have a maximum diameter of 0.75 mm or less. The core wire may have a maximum diameter of 0.7 mm or less. The core wire may have a maximum diameter of 0.65 mm or less. The core wire may have a maximum diameter of at least 0.6 mm. The core wire may have a maximum diameter of at least 0.55 mm.

[0034] The core wire may have a minimum diameter of 0.25 mm or less (e.g., the minimum diameter of the tapered portion). The core wire may have a minimum diameter of at least 0.15 mm. The core wire may have a minimum diameter of at least 0.1 mm. The core wire may have a minimum diameter of 0.25 mm or less. The core wire may have a minimum diameter of 0.2 mm or less.

[0035] At least one surface of the guidewire located at or near the distal end (for example, the outer surface (131) of the core wire (116) or the outer surface (132) of the distal tip (112)) may be surface-textured.

[0036] For example, grooves within a surface can increase the intensity and angular range of echo visibility because their reflectivity is improved compared to other convex surfaces. Figures 3A and 3B show different examples of grooves. Referring to Figure 3A, the grooves can be considered as part of a guidewire extending to a certain depth (301) below the adjacent surfaces on both sides of the groove, and each groove has a width (310).

[0037] In some embodiments, the distance (305) between grooves (300) may be the same. In some embodiments, the distance (305) between grooves may be different (for example, at least one groove may have a different spacing from an adjacent groove than the spacing between two other grooves). In some embodiments, the spacing between each groove may be 1 cm or less. In some embodiments, the spacing between each groove may be 5 mm or less. In some embodiments, the spacing between each groove may be 1 mm or less. In some embodiments, the spacing between each groove may be 0.5 mm or less. In some embodiments, the spacing between each groove may be 0.25 mm or less.

[0038] In some embodiments, the width (310) of each groove may be the same. In some embodiments, the width (310) of each groove may be different (for example, at least one groove may have a different width from the width of another groove). In some embodiments, the width of each groove may be 1 mm or less. In some embodiments, the width of each groove may be 0.5 mm or less. In some embodiments, the width of each groove may be 0.25 mm or less. In some embodiments, the width of each groove may be 0.125 mm or less.

[0039] In some embodiments, the depth (301) of each groove may be the same. In some embodiments, the depth (301) of each groove may be different (for example, at least one groove may have a different depth than another groove). In some embodiments, the depth of each groove may be less than 1 mm. In some embodiments, the depth of each groove may be 0.5 mm or less. In some embodiments, the depth of each groove may be 0.25 mm or less. In some embodiments, the depth of each groove may be 0.125 mm or less. In some embodiments, the depth of each groove may be 0.06 mm or less.

[0040] In some embodiments, the grooves may have a rectangular cross-section, as shown in Figure 3A. Referring to Figure 3B, in some embodiments, one or more corners of the groove, for example, the corners (320) connecting the groove to an adjacent outer surface, may be rounded or beveled. Other cross-sectional types are also conceivable, including "V" or "U" shapes, as can be assumed. In some embodiments, each groove has the same cross-sectional type (e.g., all rectangular, even if the dimensions may differ). In some embodiments, one or more grooves may have a different cross-sectional type compared to other grooves (e.g., (i) some grooves may be rectangular without bevels and some grooves may be rectangular with bevels, or (ii) some grooves may be rectangular in shape and others may be "V" shaped, etc.).

[0041] In some embodiments, methods may be provided. These methods may include inserting an embodiment of a guidewire device, as disclosed herein, into a subject's blood vessel through the lumen of an access device or introducer sheath. These methods may include safely passing the guidewire through the aortic valve. These methods may include attaching a medical device (such as a blood pump) to the proximal end of the guidewire device and passing the medical device along the guidewire until it is in a desired position.

[0042] Referring to Figure 4, we can see the heart (400). As can be seen, blood returning to the heart from the superior vena cava (407) passes through the right atrium (405), enters the right ventricle (403), and is then sent to the lungs. Blood returning from the lungs enters the left atrium (404), then the left ventricle (402), and then the blood leaves the heart and enters the aortic arch (406).

[0043] As previously stated, during some insertions, the guidewire may be configured to pass through the aortic arch (406) in a non-traumatic manner, preferably without a guide catheter. Guide catheters are well known in the art, and they typically comprise a tubular member having a lumen extending from a distal end to a proximal end, through which the guidewire typically extends. Such guide catheters are often used to stabilize the position of the guidewire or other devices within a blood vessel or anatomical structure, helping to prevent them from moving or causing damage. In the disclosed guidewire, one preferred configuration avoids the use of a guide catheter by having a well-designed stiffness profile that is not very flexible or soft, but flexible enough to pass through the aortic arch non-traumatically, because softer / more flexible wires may twist during insertion.

[0044] In some embodiments, a kit may be provided. The kit may include embodiments of a guidewire device as disclosed herein. The kit may include an inflation device that can be detachably attached to the proximal end of the guidewire device. In some embodiments, the kit may include an access device or introducer sheath that may have a lumen through which the guidewire device is slidably received. Such access devices are well known in the art, such as those disclosed in U.S. Patent Application Publication No. 2023 / 0233802, and similarly, introducer sheaths are also well known in the art, such as those disclosed in U.S. Patent No. 10,737,008 or U.S. Patent No. 11,517,720. In some embodiments, the kit may include an occlusion device, such as a vascular occlusion device, such as an arterial occlusion device, that may have a lumen configured to slidably receive the guidewire device. Such devices are well known in the art.

[0045] Various modifications can be made to the systems, methods, apparatus, mechanisms, techniques, and parts thereof described herein with respect to various drawings, and such modifications will be considered to be within the scope of the invention. For example, while a particular sequence of steps or arrangement of functional elements is presented in various embodiments described herein, various other sequences / arrangements of steps or functional elements may be used in the context of various embodiments. Furthermore, while modifications to embodiments may be discussed individually, various embodiments may use multiple modifications simultaneously or sequentially, or combine modifications, and so on.

[0046] [Implementation Method] (1) A guide wire, The proximal part and, A distal portion including a tapered core wire extending from the proximal portion to the distal tip, wherein the distal portion has surface texturing on at least one surface near the distal end of the distal portion, A guide wire, including one. (2) The guide wire according to Embodiment 1, wherein the guide wire does not include a coil wire. (3) The guide wire according to embodiment 1 or 2, wherein the guide wire has a 180° J tip operably connected to the tapered core wire. (4) The guide wire according to Embodiment 3, wherein at least a portion of the 180°J tip has a stiffness lower than that of the tapered core wire. (5) The 180°J tip is a guide wire according to Embodiment 3, comprising a metal-filled polymer.

[0047] (6) The guide wire according to Embodiment 5, wherein the metal-filled polyurethane is tungsten-filled polyurethane. (7) The tapered core wire is a guide wire according to any one of embodiments 1 to 6, comprising nitinol. (8) The guide wire according to Embodiment 7, wherein the guide wire includes a coating around at least a portion of the tapered core wire. (9) The guide wire according to Embodiment 8, wherein the coating comprises braided polytetrafluoroethylene (PTFE). (10) The tapered core wire is a guide wire according to any one of embodiments 1 to 9, having a circular cross-section.

[0048] (11) The tapered core wire is a guide wire according to any one of embodiments 1 to 10, having a maximum diameter of 0.6 to 0.7 mm. (12) The tapered core wire is a guide wire according to any one of embodiments 1 to 11, having a minimum diameter of 0.1 mm to 0.2 mm. (13) The tapered core wire is a guide wire according to any one of embodiments 1 to 12, having a tapered length of 70 mm to 120 mm. (14) The guide wire is the guide wire according to any one of embodiments 1 to 13, having a total length of 140 cm to 160 cm. (15) It is a kit, A guide wire according to any one of Embodiments 1 to 14, introducer sheath and / or closing device, A kit that includes this.

[0049] (16) A method for delivering a medical device, To provide a guide wire according to any one of Embodiments 1 to 15, The method involves introducing the guidewire into the heart along a pathway through at least one blood vessel, wherein the pathway passes through the aortic arch, and the guidewire is introduced into the heart without the use of a guide catheter. Methods that include... (17) The method of Embodiment 16, further comprising slidably passing the medical device along the guide wire until the medical device is at a target location.

Claims

1. A guide wire, The proximal part and, A distal portion including a tapered core wire extending from the proximal portion to the distal tip, wherein the distal portion has surface texturing on at least one surface near the distal end of the distal portion, A guide wire, including one.

2. The guide wire according to claim 1, wherein the guide wire does not include a coil wire.

3. The guide wire according to claim 1, wherein the guide wire has a 180° J tip operably connected to the tapered core wire.

4. The guide wire according to claim 3, wherein at least a portion of the 180° J tip has a stiffness lower than that of the tapered core wire.

5. The 180°J tip comprises a metal-filled polymer, as described in claim 3, for the guide wire.

6. The guide wire according to claim 5, wherein the metal-filled polyurethane is tungsten-filled polyurethane.

7. The tapered core wire comprises nitinol, as described in claim 1.

8. The guide wire according to claim 7, wherein the guide wire includes a coating around at least a portion of the tapered core wire.

9. The guide wire according to claim 8, wherein the coating comprises braided polytetrafluoroethylene (PTFE).

10. The tapered core wire has a circular cross-section, as described in claim 1.

11. The guide wire according to claim 1, wherein the tapered core wire has a maximum diameter of 0.6 to 0.7 mm.

12. The guide wire according to claim 1, wherein the tapered core wire has a minimum diameter of 0.1 mm to 0.2 mm.

13. The guide wire according to claim 1, wherein the tapered core wire has a tapered length of 70 mm to 120 mm.

14. The guide wire according to claim 1, wherein the guide wire has a total length of 140 cm to 160 cm.

15. It's a kit, A guide wire according to any one of claims 1 to 14, introducer sheath and / or closing device, A kit that includes this.

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