Echo type guide wire

Abstract

A guidewire is disclosed for use, for example, in procedures that require transarmpit entry and enhance echoreflectivity. 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 a distal tip. The distal portion may have a surface texture on at least one surface proximate a distal end of the distal portion. The guidewire may have, for example, a 180 DEG-J shaped tip operably coupled to a tapered core wire. A stiffness of at least a portion of the J-shaped tip is less than a stiffness of the tapered core wire. The J-shaped tip may include a metal-filled polymer, such as a tungsten-filled polyurethane. The tapered core wire may have a maximum diameter of 0.6 to 0.7 mm, and may have a tapered length of 70 to 120 mm.

Description

[0001] Cross-references to related applications This application claims priority to U.S. Provisional Patent Application No. 63 / 529,856, filed July 31, 2023, the contents of which are incorporated herein by reference in their entirety. Technical Field

[0002] This disclosure relates to guidewires for medical procedures, and more specifically, to echogenic axillary guidewires. Background Technology

[0003] Inserting a blood pump via the axilla in a surgical setting presents unique challenges. Conventional techniques require a guidewire change procedure because the typical guidewire cannot safely cross the aortic valve. Even if the first attempt goes smoothly, this adds several minutes to the procedure time. Inserting the appropriate guidewire often involves numerous pauses during changes to monitor the position of the wire and catheter.

[0004] Commercially available guidewires fluoresce due to their density. However, most surgical environments do not include fluoroscopy equipment. Using guidewires outside of dedicated catheter insertion labs or hybrid catheter labs / operating rooms requires the introduction of portable C-arms for fluoroscopy, which has its own complexities, including space requirements and personnel needs. While commercially available guidewires reflect ultrasound, their narrowness limits their visibility via echocardiography. For example, it is difficult to clearly determine the guidewire's position in the left ventricle because the thin wire is rarely perfectly coplanar with the ultrasound depth. Summary of the Invention

[0005] In various aspects, a guidewire may be provided. 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 a distal tip, and the distal portion has a surface texture on at least one surface near the distal end of the distal portion. The guidewire may not have a coil wire.

[0006] The guidewire may have a 180°-J-shaped tip operatively coupled to a tapered core wire. At least a portion of the stiffness of the 180°-J-shaped tip may be less than the stiffness of the tapered core wire. The 180°-J-shaped tip may comprise a metal-filled polymer, such as tungsten-filled polyurethane. The tapered core wire may comprise 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] The tapered mandrel can have a circular cross-section along its entire length. The tapered mandrel can have a maximum diameter of, for example, 0.6–0.7 mm. The tapered mandrel can have a minimum diameter of, for example, 0.1–0.2 mm. The tapered mandrel can have a tapered length of 70–120 mm. The guidewire can have a total length of 140–160 cm.

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

[0010] In various aspects, a method for delivering a medical device may be provided. The method may include providing a guidewire as disclosed herein. The method may include introducing the guidewire into the heart along a path passing through at least one blood vessel, traversing the aortic arch, wherein the guidewire is introduced into the heart without the use of a guiding catheter. The method may include sliding the medical device along the guidewire until the medical device is in a target position. Attached Figure Description

[0011] The accompanying drawings, which are included in and form a part of this specification, illustrate embodiments of the invention and, together with the overview of the invention given above and the detailed description of the embodiments given below, serve to explain the principles of the invention.

[0012] Figure 1 This is a diagram showing a cross-sectional side view of the guidewire.

[0013] Figure 2A-2C This is a diagram showing a side view of various distal tip extensions.

[0014] Figure 3A and 3B This is a diagram showing a cross-sectional view of the groove.

[0015] Figure 4 This is a diagram of a guidewire positioned inside the heart.

[0016] Figure 5 This is a diagram showing a cross-sectional side view of the guidewire.

[0017] It should be understood that the accompanying drawings are not necessarily to scale and present slightly simplified representations of various features illustrating the basic principles of the invention. Specific design features such as the sequence of operations disclosed herein (including, for example, the specific dimensions, orientations, positions, and shapes of the various illustrated components) will be determined in part by the specific intended application and usage environment. Some features of the illustrated embodiments have been enlarged or modified relative to other features for visualization and clarity. In particular, for example, thin features may be thickened for clarity or illustration. Detailed Implementation

[0018] The following description and accompanying drawings merely illustrate the principles of the invention. Therefore, it will be appreciated that those skilled in the art will be able to devise various arrangements that, while not explicitly described or shown herein, embody the principles of the invention and are included within its scope. Furthermore, all embodiments described herein are primarily intended for illustrative purposes to aid the reader in understanding the principles of the invention and the concepts contributed by the inventors to the field, and should be understood as not being limited to such specifically described embodiments and conditions. Additionally, the term "or," as used herein, refers to a non-exclusive "or" unless otherwise indicated (e.g., "or otherwise" or "or alternatively"). Moreover, 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.

[0019] Many of the innovative teachings of this application will be described with particular reference to the presently preferred exemplary embodiments. However, it should be understood that such embodiments provide only a few examples of the many advantageous uses of the innovative teachings herein. In general, the statements made in this specification do not necessarily limit any of the various claimed inventions. Furthermore, some statements may apply to some inventive features but not to others. Those skilled in the art and those who have learned from the teachings herein will recognize that the invention is also applicable to a variety of other technical fields or embodiments.

[0020] In various aspects, a guidewire for delivering catheter-based devices can be provided, having a surface treated to increase echogenicity at or near the distal end. 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 has been done with needles used to obtain access for percutaneous interventions. This makes it easier to determine the correct position of the guidewire on echocardiography without requiring the commonly used fluoroscopy.

[0021] As described above, this addresses the problem of limited guidewire visibility on echocardiography, such as when echoes are used to monitor blood pump delivery (e.g., one of Abiomed's IMPELLA® blood pumps) and localization in, for example, the left ventricle.

[0022] The current delivery guidewire is modeled after a standard 0.018” diameter, 260 cm long wire designed for the femoral artery approach. This requires a wire replacement procedure because it cannot safely cross the aortic valve, increasing the procedure's time and complexity (e.g., 4-5 minutes if the first attempt goes smoothly), during which numerous pauses are needed to monitor wire and catheter position. Adding to the complexity is that these wires are often difficult to visualize via transesophageal echocardiography, the most common imaging method in the operating room.

[0023] In addition to improving visibility during fluoroscopy, increased echogenicity can be desirable for better wire localization, as some surgeons may not use fluoroscopy during delivery.

[0024] like Figure 1 As shown, the guidewire (100) may include: a distal segment (110), which may include a distal tip (112); an optional coil wire (114); a core wire (116); and a transition segment (118). The guidewire may include a proximal segment (120) having a proximal end (122) (e.g., a proximal segment of the core wire (116)).

[0025] If a coil wire (114) is used, it can provide resistance to radial deformation and allow the guidewire (100) to return to its original shape, even after deformation that the guidewire (100) may have undergone during placement or manipulation in the heart. The coil wire (114) surrounds the core wire (116). Brief Reference Figure 5 In a preferred embodiment, the guide wire has no coil wire.

[0026] refer to Figure 1 The core wire (116) may have a diameter that decreases from the transition section (118) to the tip (112) of the distal section. The distal section (110) may have a length L2 (198).

[0027] The core wire (116) may also include a proximal segment (120) extending between the proximal end (122) and the transition segment (118). In some embodiments, the proximal segment (120) may have a constant diameter. In some embodiments, the diameter of the proximal segment may vary. The proximal segment may be generally cylindrical with a circular cross-section. The proximal segment (120) may have a length L1 (199).

[0028] In some embodiments, L2 can be between 50-75% of the total length of the core filament (116). In some embodiments, L2 can be between 20-60% of the total length of the core filament (116). In some embodiments, L1 can be between 40-80% of the total length of the core filament (116). In some embodiments, L1 can be between 25-50% of the total length of the core filament (116).

[0029] The distal segment (110) of the core wire can be more flexible than the proximal segment of the guidewire (100). This allows the physician to initially place the guidewire into the patient with minimal damage to the patient's arterial system.

[0030] Reference Figure 2A-2C In various embodiments, the distal tip (112) may include a distal extension. This distal extension may, for example, be a 180°-J-shaped tip (201, Figure 2A), 270° tip (202, Figure 2B ), or even the closed-loop tip (203, Figure 2C ).

[0031] In various embodiments, the tip (112) may be a platinum alloy. In various embodiments, the tip (e.g., a tip with a distal extension) may be non-invasive (e.g., relatively soft and flexible). In various embodiments, the tip may be tungsten-filled polyurethane. The tip may have a stiffness gradient, with the highest stiffness near the core wire.

[0032] The guidewire (100) may include nitinol. For example, the core wire (116) may include nitinol.

[0033] At least a portion of the guidewire may include a coating. In some embodiments, the proximal segment (e.g., proximal segment (120)) may include a coating. In some embodiments, the core wire may include a coating. For example, as Figure 5 As shown, the coating (510) can be disposed around some or all of the core filaments (116). The coating can be, for example, a braided polytetrafluoroethylene (PTFE) coating. The coating can be monochromatic or multicolor (e.g., two-color) coating.

[0034] The conical core can have a circular cross-section and may or may not have a flat end.

[0035] The length of the guidewire can be customized based on the intended delivery method. For example, the guidewire can have a total length of no more than 250 cm. The guidewire can have a total length of no more than 225 cm. The guidewire can have a total length of no more than 200 cm. The guidewire can have a total length of no more than 175 cm. The guidewire can have a total length of no more than 160 cm. The guidewire can have a length of at least 125 cm. The guidewire can have a length of at least 140 cm. The guidewire can have a total length of at least 150 cm. The guidewire can have a total length between 125 and 175 cm.

[0036] The guidewire may have a tapered length L3 (197) not greater than 150 mm (e.g., the axial distance by which the guidewire tapers). The guidewire may have a tapered length not greater than 140 mm. The guidewire may have a tapered length not greater than 130 mm. The guidewire may have a tapered length not greater than 120 mm. The guidewire may have a tapered length not greater than 110 mm. The guidewire may have a tapered length not greater than 100 mm. The guidewire may have a tapered length of at least 70 mm. The guidewire may have a tapered length of at least 80 mm. The guidewire may have a tapered length of at least 90 mm. The guidewire may have a tapered length of 70–120 mm.

[0037] The core wire may have a maximum diameter of not more than 0.8 mm (196). The core wire may have a maximum diameter of not more than 0.75 mm. The core wire may have a maximum diameter of not more than 0.7 mm. The core wire may have a maximum diameter of not more than 0.65 mm. 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.

[0038] The core wire may have a minimum diameter of no more than 0.25 mm (e.g., the minimum diameter of a tapered core wire is no more than 0.25 mm). 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 no more than 0.25 mm. The core wire may have a minimum diameter of no more than 0.2 mm.

[0039] At least one surface at or near the distal end of the guidewire (such as the outer surface (131) of the core wire (116) or the outer surface (132) of the distal tip (112)) may be surface-textured.

[0040] For example, grooves in a surface can increase the intensity and angular range of echo visibility because the reflectivity is improved compared to the original convex surface. Figure 3A and 3B Different examples of grooves are illustrated. (Reference) Figure 3A The groove can be considered as part of the guide wire, which extends to a certain depth (301) below the adjacent surfaces on both sides of the groove, and each groove has a width (310).

[0041] In some embodiments, the distance (305) between the grooves (300) may be the same. In some embodiments, the distance (305) between the grooves may vary (e.g., the spacing between at least one groove and its adjacent groove may be different from the spacing between two other grooves). In some embodiments, the spacing between each groove may be no greater than 1 cm. In some embodiments, the spacing between each groove may be no greater than 5 mm. In some embodiments, the spacing between each groove may be no greater than 1 mm. In some embodiments, the spacing between each groove may be no greater than 0.5 mm. In some embodiments, the spacing between each groove may be no greater than 0.25 mm.

[0042] In some embodiments, the width (310) of each groove may be the same. In some embodiments, the width (310) of each groove may vary (e.g., the width of at least one groove may be different from the width of another groove). In some embodiments, the width of each groove may not be greater than 1 mm. In some embodiments, the width of each groove may not be greater than 0.5 mm. In some embodiments, the width of each groove may not be greater than 0.25 mm. In some embodiments, the width of each groove may not be greater than 0.125 mm.

[0043] In some embodiments, the depth (301) of each groove may be the same. In some embodiments, the depth (301) of each groove may vary (e.g., the depth of at least one groove may be different from the depth of 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 no greater than 0.5 mm. In some embodiments, the depth of each groove may be no greater than 0.25 mm. In some embodiments, the depth of each groove may be no greater than 0.125 mm. In some embodiments, the depth of each groove may be no greater than 0.06 mm.

[0044] In some embodiments, the groove may have a rectangular cross-section, such as... Figure 3A As shown. Reference Figure 3B In some embodiments, one or more corners of the groove (such as the corner (320) that connects the groove to an adjacent outer surface) may be rounded or beveled. Other cross-sectional types, including “V” or “U” shapes, are also contemplated, as will be expected. In some embodiments, each groove has the same cross-sectional type (e.g., all are rectangular shapes, etc., even if the dimensions may vary). In some embodiments, one or more grooves may have different cross-sectional types compared to another groove (e.g., (i) some grooves may be rectangles without bevels and some grooves may be rectangles with bevels, or (ii) some grooves may be rectangular shapes while others are “V” shapes, etc.).

[0045] In some embodiments, a method may be provided. This method may include inserting an embodiment of a guidewire device, as disclosed herein, into a blood vessel of a subject via the lumen of an access device or guide sheath. This method may include safely traversing the aortic valve with the guidewire. This method may include attaching a medical device, such as a blood pump, to the proximal end of the guidewire device and guiding the medical device along the guidewire until the medical device is in the desired position.

[0046] refer to Figure 4The heart (400) can be seen. As can be seen, blood returning to the heart from the superior vena cava (407) passes through the right atrium (405) and enters the right ventricle (403) before being sent to the lungs. Blood returning from the lungs enters the left atrium (404), then the left ventricle (402), after which the blood leaves the heart and enters the aortic arch (406).

[0047] As described above, during some insertions, the guidewire can be configured to cross the aortic arch (406) in a non-invasive manner, and preferably without the use of a guiding catheter. Guiding catheters are well known in the art; they typically comprise a tubular member having a lumen extending from a distal end to a proximal end, through which the guidewire will typically extend. Such guiding catheters are often used to stabilize the position of guidewires or other devices within a blood vessel or anatomical structure, helping to prevent them from shifting or causing injury. For the disclosed guidewires, a preferred configuration avoids the use of a guiding catheter by having a suitably designed stiffness profile that is neither too flexible nor too soft (as softer / more flexible wires may kink during insertion), but is still flexible enough to cross the aortic arch non-invasively.

[0048] In some embodiments, a kit may be provided. The kit may include embodiments of guidewire devices as disclosed herein. The kit may include an expansion device removably attached to the proximal end of the guidewire device. In some embodiments, the kit may include an access device or guide sheath having a lumen therethrough adapted to slidably receive the guidewire device. Such access devices are well known in the art, such as those disclosed in US2023 / 0233802, as are guide sheaths, such as those disclosed in US 10,737,008 or US 11,517,720. In some embodiments, the kit may include a closure device, such as a vascular closure device or an arterial closure device, which may have a lumen adapted to slidably receive the guidewire device. Such devices are well known in the art.

[0049] Various modifications can be made to the systems, methods, apparatus, mechanisms, techniques, and parts thereof described herein with reference to the various accompanying drawings, and such modifications are considered to be within the scope of the invention. For example, although a particular order of arrangement of steps or functional elements is presented in the various embodiments described herein, various other orders / arrangements of steps or functional elements may be utilized within the context of the various embodiments. Furthermore, while modifications to embodiments may be discussed individually, various embodiments may employ multiple modifications, compound modifications, etc., simultaneously or sequentially.

Claims

1. A guidewire, comprising: Proximal portion; and The distal portion includes a tapered core wire extending from the proximal portion to a distal tip, and the distal portion has a surface texture on at least one surface near the distal end of the distal portion.

2. The guidewire according to claim 1, wherein, The guide wire does not contain coiled wire.

3. The guidewire according to claim 1 or 2, wherein, The guidewire has a 180°-J-shaped tip that is operatively connected to the tapered core wire.

4. The guidewire according to claim 3, wherein, At least a portion of the stiffness of the 180°-J-shaped tip is less than the stiffness of the tapered core wire.

5. The guidewire according to claim 3, wherein, The 180°-J-shaped tip comprises a metal-filled polymer.

6. The guidewire according to claim 5, wherein, The metal-filled polyurethane is tungsten-filled polyurethane.

7. The guidewire according to any one of claims 1 to 6, wherein, Tapered core wires include nickel-titanium.

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

9. The guidewire according to claim 8, wherein, The coating comprises woven polytetrafluoroethylene (PTFE).

10. The guidewire according to any one of claims 1 to 9, wherein, The tapered core wire has a circular cross-section.

11. The guidewire according to any one of claims 1 to 10, wherein, The tapered core wire has a maximum diameter of 0.6-0.7 mm.

12. The guidewire according to any one of claims 1 to 11, wherein, The tapered core wire has a minimum diameter of 0.1 mm to 0.2 mm.

13. The guidewire according to any one of claims 1 to 12, wherein, The tapered core wire has a tapered length of 70 mm to 120 mm.

14. The guidewire according to any one of claims 1 to 13, wherein, The guidewire has a total length of 140 cm to 160 cm.

15. A kit comprising: The guidewire according to any one of claims 1 to 14; and Guide sheath and / or closure device.

16. A method for delivering a medical device, comprising: Provide a guidewire according to any one of claims 1 to 15; A guidewire is introduced into the heart along a path that passes through at least one blood vessel, the path crossing the aortic arch, wherein the guidewire is introduced into the heart without the use of a catheter.

17. The method according to claim 16, wherein, It also includes allowing the medical device to slide along the guidewire until the medical device reaches the target position.

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