Guide wire

The guide wire design with a core wire and dual spiral coil structure addresses torsional stiffness and flexibility issues, enhancing navigation and visibility in intracranial vessels.

JP2025522920APending Publication Date: 2025-07-17PHENOX GMBH
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Patent Information

Application Number
JP2025500314
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2022-07-11
Filing Date
2023-07-07
Publication Date
2025-07-17

AI Technical Summary

Technical Problem

Existing guide wires face issues with torsional stiffness, kink resistance, and flexibility in navigating tortuous intracranial vessels, particularly due to unwinding or compression of wire coils during rotational movement, and inadequate material properties for X-ray visibility and flexibility.

Method used

A guide wire design featuring a core wire surrounded by a wire coil composed of at least two separate wires in a spiral shape, connected at specific points along the coil, with varying material properties and structural adjustments to enhance torsional rigidity, flexibility, and X-ray visibility.

Benefits of technology

Improves torsional rigidity and dimensional stability, prevents unwinding of the wire coil, maintains flexibility, and ensures adequate X-ray visibility, reducing the risk of vessel damage during navigation.

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Abstract

The present invention relates to a guide wire (1) comprising a core wire (2) extending from a proximal end to a distal end, with a proximal portion (3) adjacent to the proximal end and a distal portion (4) adjacent to the distal end. The distal portion (4) of the core wire (2) is surrounded by at least one wire coil (5), and the wire coil (5) consists of at least two separate wires (6) extending in a spiral shape side by side with respect to each other. The at least two wires (6) are connected to each other at a plurality of connection points (7) along the wire coil (5). The guide wire (1) according to the present invention is characterized by a high level of dimensional stability and an improvement in the transmission of rotational movement.
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Description

Technical Field

[0001] The present invention relates to a medical guide wire including a core wire extending from a proximal end to a distal end, the proximal portion being adjacent to the proximal end, the distal portion being adjacent to the distal end, and the distal portion of the core wire being surrounded by at least one wire coil.

Background Art

[0002] In many medical interventions such as angioplasty, or the placement of stents and flow diverters, and intravascular examinations, guide wires are used to carry other medical devices to a target location. In particular, the guide wire opens a path within the vascular system, for example, for a catheter or a balloon catheter, and once the guide wire is placed, the catheter or balloon catheter can be advanced over the guide wire. And other medical devices can be carried to the target location by or through the catheter (for example, a thrombectomy device, a stent, a flow diverter, or an implant for treating an aneurysm). In particular, the catheter may be a microcatheter.

[0003] In such a context, it is often necessary to move the guide wire distally over a long distance (e.g., from the femoral artery to the intracranial vessels). Thus, the length of the guide wire may be about 1.30 - 3.50 m. One problem that arises in such a context is that the intracranial vessels are usually thin and tortuous, so the guide wire must be sufficiently flexible. However, it is also important to avoid the guide wire bending or even kinking during advancement (''kink resistance''). Finally, torque must be transmitted during advancement, and for this reason, the guide wire cannot be too flexible over its entire length. The guide wire also often has a special shape at the distal end to enable access to the outer vessels. For example, the distal end may be curved or bent in a lateral or proximal direction (e.g., 45° or 90° bend, or J-shaped or cane-shaped). Thus, the distal end must be malleable and retain this shape (shape retention).

[0004] Thus, for the reasons stated, guide wires are often composed of a plurality of different parts, with the proximal part usually being stiffer and less flexible to ensure the ability to advance and transmit torque, and the distal part being designed to be very flexible to follow the thin vessels. For this purpose, the proximal part of the guide wire can be formed of a material different from that of the distal part (usually a metal or alloy). It is also known to reduce the outer diameter at the distal part of the guide wire.

[0005] Furthermore, a wire coil is often fixed at the distal part of the guide wire. Thus, the guide wire has an internal core wire and a wire coil disposed on the core wire. The wire coil is often formed of a radiopaque material so that the insertion of the guide wire (especially its correct positioning in the target area) can be monitored using X-rays. Thus, the wire coil can be formed, for example, of platinum or platinum-iridium wire.

[0006] However, the characteristics of the corresponding coils in the distal portion of the guidewire from the prior art are not entirely optimal. This is especially true for torsional stiffness. It is often necessary to rotate the guidewire to follow the path of the blood vessel, and the treating physician is gripping the guidewire in a much more proximal region outside the body. Therefore, the rotational movement must be transmitted over a long distance. In the region of the wire coil attached at the distal portion, there is a problem that the wire coil resting on the inner wall of the blood vessel may unwind or be further compressed in response to the rotational movement. Therefore, the wire coil will "store" the introduced rotational movement, and the stored energy may be suddenly released. This is not desirable. Firstly, because the attending physician cannot control sudden movements, and secondly, because there is a risk of damaging the blood vessel wall.

[0007] Furthermore, by using platinum or a platinum alloy for the wire coil, sufficient X-ray visibility is ensured, but these metals are not optimal in other respects. In particular, they cause undesirable hardening in the distal portion of the guidewire, where sufficient flexibility is important to follow the curvature of the blood vessel. SUMMARY OF THE INVENTION

[0008] The object of further improving the guidewire known from the prior art is achieved by a guidewire comprising a core wire extending from a proximal end to a distal end, a proximal portion adjacent to the proximal end, a distal portion adjacent to the distal end, the distal portion of the core wire being surrounded by at least one wire coil, the wire coil consisting of at least two separate wires extending side by side in a spiral shape, and the at least two wires being connected to each other at a plurality of connection points along the wire coil.

[0009] In the guide wire according to the present invention, the wire coil is composed of at least two separate wires extending in a spiral shape side by side with each other. Therefore, the wires are wound parallel to each other, and the wire coil is composed of at least two separate coils pushed into each other. In most cases, the wire coil is composed of two separate wires, but in principle, a structure formed by three or more wires is also possible.

[0010] Furthermore, the wire coil and the wires forming the separate coils are selectively connected to each other, that is, at a specific connection point. As a result, the torsional rigidity is significantly improved. In particular, the above-mentioned adverse effect that spring energy is accumulated in the wire coil when rotational motion is transmitted can thus be eliminated.

[0011] A guide wire having a wire coil (the wire having a plurality of connection points along the wire coil between the windings of the wire coil) is known from US10,639,456. However, in contrast to the present invention, these are connection points between the windings of a single wire. In particular, the present invention further improves the dimensional stability and the transmission of rotational motion and torque.

[0012] The core wire is mainly the wire that forms the guide wire. The guide wire usually has a significantly larger outer diameter than the wire forming the wire coil. In particular, the wire coil can be designed such that the guide wire in the region of the wire coil has a diameter that is the same as or slightly larger than the diameter of the proximal portion where only the core wire is present. In other words, the diameter of the core wire in the proximal portion without the wire coil is larger than that of the distal portion with the wire helix, but the decrease in the diameter of the core wire is compensated by the addition of the wire coil, and the guide wire has an approximately constant diameter overall. A slightly larger diameter is understood to mean a diameter that exceeds the diameter of the core wire in the proximal region by up to 30%, especially up to 20%, and more preferably up to 10% at most. The core wire is usually of a solid design, but a core wire having an internal cavity or lumen is not excluded. The wire coil can advantageously be firmly connected to the core wire by welding, and the welding or other connection points are usually provided at the proximal and distal ends of the wire coil.

[0013] The distal portion is understood to be the region of the guide wire adjacent to the distal end of the guide wire in the proximal direction, and the distal end itself may or may not be part of the distal portion. The distal portion is shorter than the proximal portion and usually has a length of about 40 - 450 mm, especially 250 - 400 mm, and particularly preferably about 300 mm. It is advantageous for the length not to be too short in terms of torsional rigidity and in preventing the wire coil from unwinding or compressing. The distal end of the guide wire itself is conveniently non-traumatic, especially rounded, in order to prevent damage to the advancing blood vessel wall.

[0014] The proximal portion is understood to be the region of the guide wire adjacent to the proximal end of the guide wire in the distal direction, and the proximal end itself may or may not be part of the proximal portion. Usually, the proximal portion is considerably longer than the distal portion and occupies at least a significant part of the total length of the guide wire. Optionally, a central portion can be arranged between the distal portion and the proximal portion.

[0015] The terms "proximal" and "distal" are understood such that when inserting a guide wire, the part facing the attending physician is referred to as proximal, and the part facing away from the attending physician is referred to as distal. Thus, the guide wire is typically advanced distally through the vasculature. The term "axial" refers to the longitudinal axis of the device extending from the proximal side to the distal side, and the term "radial" refers to a plane perpendicular thereto.

[0016] Advantageously, the core wire has an outer diameter in the distal portion that is smaller than that in the proximal portion. This corresponds to the structure of conventional guide wires. By reducing the diameter in the distal portion, it is ensured that even when a wire coil is applied, the overall diameter of the guide wire does not become too large or even remains substantially constant. The transition between the proximal or central portion of the core wire with a larger diameter and the distal portion with a smaller diameter is preferably made continuously via a conical transition portion. However, it is also possible in principle to make the transition in the form of one or more steps.

[0017] The wire coil can be placed directly on the distal portion of the core wire, or a space can be provided between the wire coil and the distal portion of the core wire.

[0018] It stands to reason that the connection points between the wires of the wire coil are weld points. Connecting the various components of the guide wire by welding, even when different metals come into contact with each other, is generally known and proven from the prior art. However, it does not exclude the use of other techniques for forming the connection points (e.g., soldering or adhesion). The connection between the wire coil and the core wire can in particular be achieved by welding, but does not exclude alternative connection techniques (e.g., soldering or adhesion).

[0019] According to a first advantageous embodiment, the connection points connecting the wires forming the wire coil are provided at least partially in pairs, i.e., to each connection point, a further connection point forming a connection point pair is assigned. An offset of approximately 180° between the connection points of the connection point pair has proven to be advantageous. An offset of approximately 180° is also understood to be an offset slightly deviating from the ideal value of 180°, for example, 5° or 10° higher or lower.

[0020] In such a context, when referring to the offset between two connection points, this refers to a substantially circular cross-section in a plane orthogonal to the longitudinal axis of the guide wire. When considering such a cross-section as a circle divided into degrees (360° forming a complete circle), an offset of 180° means connection points on opposite sides of each other. Since the wire extends in a spiral shape, this of course also means that there is a certain distance between the connection points in the longitudinal direction.

[0021] Subsequent connection point pairs are usually offset from the previous connection point pair by, for example, 15° to 90°. The first connection point of the subsequent connection point pair viewed axially is correspondingly offset from the first connection point of the previous connection point pair by 15° to 90°, and the second connection point of the subsequent connection point pair viewed axially is offset from the second connection point of the previous connection point pair by 15° to 90°. Looking along the length of the wire coil, this results in a twist similar to the rifling of a rifled barrel. This ensures good flexibility of the distal portion of the guide wire. It is also possible for the offset between connection point pairs to increase from the proximal side to the distal side, and as a result, the density of the connection points to decrease from the proximal side to the distal side, thus increasing flexibility.

[0022] According to a second advantageous embodiment, the offset between the connection points of the connection point pair is 30° to 60°, preferably about 45°. The subsequent connection point pair is offset from the previous connection point pair, i.e., conveniently by 130° to 440°. In other words, the offset between the first connection points of two consecutive connection point pairs and the offset between the second connection points of two consecutive connection point pairs are 130° to 440°.

[0023] According to a particularly preferred embodiment, the offset between the connection point pairs varies and the offset increases from the proximal side to the distal side. Thus, the distal region of the wire coil has fewer connection points than the proximal region. For example, the offset between the connection point pairs can be 130° in the proximal region and 440° in the distal region. Thus, the distal region is characterized by a high level of flexibility, and the proximal region is characterized by greater rigidity and better torque transmission. The transition from a small offset to a large offset of the connection point pair can be continuous, for example, starting from an offset of 130° and passing through a plurality of intermediate values up to an offset of 440°. However, it is also possible to provide different regions arranged longitudinally before and after such that the offsets of the connection points are different (i.e., the density of the connection points changes gradually).

[0024] The aforementioned US10,639,456 describes a system in which the first and second connection points face each other, and the third and fourth connection points are offset by 90° with respect to the first and second connection points. However, in contrast to the present invention, there are no connection points between the plurality of wires. Furthermore, this document does not show any variation of the offset suitable for adjusting the characteristics (especially flexibility) of the guide wire as desired.

[0025] Even when a connection point pair that substantially faces each other is not formed, it stands to reason to provide an offset (for example, 15° to 270°) between each of the connection points in order to favorably affect the flexibility of the distal portion of the guide wire.

[0026] Flexibility can be adjusted by reducing the number of connection points between wires from the proximal side to the distal side along the wire coil. In this way, the wire coil is stiffer on the proximal side and more flexible on the distal side, which meets the purpose of making the guide wire as flexible as possible, especially on the distal side.

[0027] By using different materials for the wires, the advantageous properties of different materials are combined. By selecting different materials for the wires forming the wire coil, the properties of the wire coil (and thus the distal portion of the guide wire) can be optimally adjusted. In particular, the material of the first wire can be advantageously adjusted with respect to the desired properties of the wire coil, and the material of the second wire can be advantageously adjusted with respect to another desired property.

[0028] It is advantageous to make at least one of the wires forming the wire coil radiopaque. Various metals and alloys can be used for this purpose. Examples of possible materials include platinum or platinum alloys, such as platinum iridium alloys. Other options include platinum tungsten and platinum nickel alloys, palladium, tantalum, gold, and tungsten. It is also possible to obtain radiopacity by coating the wire with gold. The thickness of the coating can be, for example, 1 - 6 μm. Platinum nickel alloys are advantageous due to their higher strength for improving formability and durability.

[0029] To enhance the elasticity of the distal portion of the guide wire, it is advantageous to form at least one of the wires forming the wire coil from a superelastic or pseudoelastic alloy (shape memory alloy). Nickel - titanium alloys (such as those known as Nitinol) are particularly suitable as pseudoelastic alloys.

[0030] Another possibility is to manufacture at least one of the wires forming the wire coil from a cobalt chromium alloy. Cobalt chromium alloys have advantageous properties with regard to torque transmission and controllability over long distances. This is due to their high modulus of elasticity (Young's modulus) and shear modulus of elasticity. The high yield strength provides good protection against kinking ("kink resistance") and good protection against permanent bending. Cobalt-chromium-nickel alloys and cobalt-chromium-nickel-molybdenum alloys are particularly preferred. In particular, since these may contain little titanium, the properties are further improved. The corresponding alloy is known by the name 35NLT®.

[0031] As far as references to alloys in the context of the present invention are concerned, it is here made clear that referring to a metal as a component of this alloy does not exclude the possibility that the alloy contains other components. For example, a cobalt chromium alloy can also contain other components such as nickel or molybdenum in addition to cobalt and chromium. Similarly, a platinum iridium alloy does not have to have platinum and iridium as its only components. As far as references to metals in the context of the present invention are concerned, these include alloys, and alloys can also contain non-metals such as carbon or nitrogen in addition to metals. The possibilities and examples given for certain metals and alloys (such as superelastic / pseudoelastic alloys, radiopaque alloys, cobalt chromium alloys, etc.) apply to all references to these alloys in the context of this description, even if they are not explicitly mentioned at a particular place, unless otherwise specifically stated in this text.

[0032] It is also particularly preferable to use DFT (drawn filled tube) wire as the wire for constructing the wire coil. Since the DFT wire has a specific metal formed inside and a sheath formed of another metal, the wire has the characteristics of both metals. In particular, the DFT wire can have a radiopaque interior and a pseudoelastic sheath. The materials described above can be used. In particular, a platinum alloy can be used to obtain radiopacity, and a nickel-titanium alloy can be used to obtain pseudoelasticity.

[0033] It stands to reason that one of the wires wound adjacent to each other is made radiopaque and the second wire is made of a pseudoelastic alloy or a cobalt-chromium alloy. The DFT wire is also an option for the second wire, especially those having a radiopaque interior and a sheath formed of a pseudoelastic alloy or a cobalt-chromium alloy.

[0034] It is also possible to configure at least two wires forming the wire coil from a pseudoelastic alloy, particularly a nickel-titanium alloy. To obtain radiopacity, a third wire formed of a radiopaque material such as a platinum alloy can be inserted between the other wires. The cross-section of this third wire can be made smaller than that of the other wires.

[0035] To adjust the lateral stiffness of the wire coil, the pitch of the wire coil or the individual wires forming the wire coil can be varied from the proximal side to the distal side. In particular, the pitch in the distal region of the wire coil may be smaller than that in the proximal region. Correspondingly, the winding is tighter on the distal side than on the proximal side. This can be done partially, but a uniform transition in which the pitch continuously decreases from the proximal side to the distal side is preferred.

[0036] The winding of the wire forming the wire coil can be designed such that there is space between the wires or the wires are in direct contact with each other. In this way, the flexibility of the wire coil, and thus also the flexibility of the guide wire, can be specifically adjusted. A wire coil with a larger space tends to be more flexible than a wire coil with a smaller, less, or no space.

[0037] The proximal portion and any central portion of the core wire can be formed at least partially of a cobalt-chromium alloy. The proximal portion, optionally together with the central portion, occupies the largest part of the length of the guide wire, thereby ensuring that the guide wire can be easily controlled and has sufficient kink resistance. However, it is also possible to use other materials such as stainless steel.

[0038] In the distal portion, the core wire is preferably formed of a superelastic alloy, particularly a nickel-titanium alloy. Generally, the distal portion is considerably shorter than the proximal portion, for example, having a length of about 40 - 450 mm, particularly 250 - 400 mm, and particularly preferably about 300 mm. By using a superelastic alloy in the distal portion, a high level of flexibility is ensured, particularly in the region where flexibility is most important.

[0039] Therefore, it also makes sense to design the core wire with different portions of different flexibility, and the flexibility in the distal portion is usually higher than that in the proximal portion. For this purpose, as described, different materials can be used in different portions, but it is also possible to affect the flexibility through the thickness of the material or the cross-section of the core wire. In this case, the core wire usually has a larger cross-section on the proximal side than on the distal side. When different materials, particularly metals or alloys, are used in different portions, they are usually welded to each other at the transition point.

[0040] Furthermore, the use of DFT wires is also particularly preferred for the core wires, especially in the distal portion. A core wire having a radiopaque interior and a superelastic sheath combines the properties of radiopacity and flexibility, which are particularly important in the distal portion. A core wire having a radiopaque interior and a sheath formed of a cobalt-chromium alloy is also possible.

[0041] According to a particularly preferred embodiment, the entire or at least most of the core wire is formed of a wire having a superelastic interior and a sheath formed of a cobalt-chromium alloy or a cobalt-chromium-nickel alloy. In the distal portion, the sheath is completely or partially removed from the core wire. This can be achieved, in particular, by a grinding process. This process can be carried out until finally only the superelastic interior of the wire remains in the distal portion, but this is not absolutely necessary since flexibility has already been ensured by removing a part of the sheath. The advantage of this method is, in particular, that dissimilar welding of different parts of the core wire is not required.

[0042] Another advantage of a core wire made of a superelastic or pseudoelastic alloy such as nitinol is that it can be shaped by appropriate heat treatment, at least in the distal portion. Good superelastic properties ensure shape retention, which is particularly important since the distal end of the guide wire often has curves or bends to facilitate exploring the path of blood vessels and positioning branched blood vessels.

[0043] One or more of the wires forming the wire coil can also be formed as a coil, i.e., they can be twisted before the wire is further wound into the shape of a wire coil. As a result, a wound coil or a double coil consisting of a primary coil converted into a secondary coil is formed. In the wire coil (i.e., the secondary coil), a plurality of wires wound as the primary coil can be positioned adjacent to each other. However, it is also conceivable to twist only one or a part of the wires forming the wire coil before forming the wire coil.

[0044] A plurality of wire coils can also be arranged vertically in the radial direction at the distal portion of the core wire. In other words, one wire coil can be arranged further outside with respect to another wire coil, and the overlap of the wire coils can be complete or partial. A guide wire with wire coils arranged vertically is known, for example, from US8,480,598B2. At least one of the wire coils is formed from at least two separate wires as described according to the present invention. The overlap of the separate wire coils does not have to be complete, and it is also possible that one or more wire coils are shorter than others and / or overlap only partially.

[0045] When a plurality of wire coils are arranged overlapping each other, it is advantageous to wind them in opposite directions, i.e., one as a left coil and one as a right coil, or to wind them alternately. This also improves the torque transmission. This is because the difference in the rotation direction is compensated by the reverse rotation of the wire coils.

[0046] At least two wires forming the wire coil do not necessarily have to extend in a spiral shape side by side over the entire length of the wire coil, but they should do so over most of its length, preferably over at least 70%, more preferably over at least 80%, and even more preferably over at least 90% of the total length of the wire coil. However, the most preferred solution is that the wires forming the wire coil extend side by side along the entire length of the wire coil, i.e., 100%.

[0047] At the distal end, the guide wire can have a bend or a curve. For example, the guide wire can have a total bend or curve of 45° to 180°, such as 90° or 135° at the distal end. As a result, the guide wire assumes a J or cane shape at the distal end. One advantage is that, on the one hand, it becomes easier to explore and advance into narrow blood vessels. This is because the curved or bent tip can rotate to a position that more easily follows the curvature of the blood vessel. On the other hand, a guide wire with a distal bend or curve is less traumatic, i.e., the risk of damage to the blood vessel wall is reduced. Maintaining the shape of the guide wire at the distal end helps the guide wire perform its task. The wire coil can be disposed entirely or partially in the region of the bend / curve or proximal thereto.

[0048] In most cases, both the wire forming the wire coil and the core wire have a circular cross-section. However, in principle, other shapes, especially those with an elliptical cross-section, are also conceivable.

[0049] The properties of the guide wire or a separate component of the guide wire can be affected by methods known from the prior art, for example, by cold forming, heat treatment, annealing, or recrystallization annealing.

[0050] It stands to reason that the guide wire has a polymer shell on the outside. A hydrophilic coating can also be applied in addition to or instead of the polymer shell. In particular, PTFE (polytetrafluoroethylene) or another fluoropolymer can be used for the polymer shell. Other materials that can be used for the polymer shell are polyamide, polyurethane, polyvinyl chloride, polyester, polystyrene, polyimide, polycarbonate, polyolefin, such as polypropylene or polyethylene, or silicone. The polymer shell and / or the hydrophilic coating do not have to extend over the entire length of the guide wire, and partial coating or coating is also possible. For example, a polymer shell may be provided on the proximal portion, and a hydrophilic coating may be applied on the distal side to improve the slidability of the guide wire. The hydrophilic coating can extend beyond the distal portion carrying the wire coil and can extend, for example, over a length of 30 to 40 cm. For example, polyvinylpyrrolidone, a cellulose-based polymer, or polyvinyl alcohol can be used as the hydrophilic coating.

[0051] The guide wire according to the present invention can be used particularly in the neurovascular field, but can also be used in the cardiovascular or peripheral fields. The guide wire is particularly important for intracranial vessels and coronary vessels. This is because in such cases, on the one hand, it is necessary to reach vessels with a narrow lumen, and on the other hand, the guide wire has to be advanced over a relatively long distance.

[0052] The diameter of the guide wire is usually in the range of 0.2 to 0.5 mm, but the diameter does not have to be constant over the entire length.

[0053] The guidewire according to the present invention can be used in conjunction with an OTW (over-the-wire) catheter (where the guidewire advances through the entire lumen of the catheter) and an Rx (rapid exchange) catheter. In this case, the guidewire advances only through the distal portion of the catheter, which is typically about 20 to 40 cm in length. Thus, the catheter has an opening proximal to the distal portion through which the guidewire advances and exits the lumen of the catheter. Such an opening is also known as a port. The OTW and Rx systems are well known to those skilled in the art (e.g., in the field of balloon catheters).

[0054] At the proximal end, a handle can be provided on the guidewire to make it easier for the attending physician to handle the guidewire.

[0055] In addition to the guidewire itself according to the present invention, the present invention relates to the use of the guidewire and the combination of the guidewire with other medical devices.

[0056] All descriptions of features of the present invention refer to all embodiments in each case, unless a different meaning is indicated by the context.

Brief Description of the Drawings

[0057]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Best Mode for Carrying Out the Invention

[0058] The present invention will be described in more detail with reference to the examples of the embodiments shown in the drawings. It should be noted that although the drawings show variations of the preferred embodiments of the present invention, the present invention is not limited thereto. Generally, the present invention includes any combination of technical features listed in the claims or described in the description as related to the present invention, as long as it is technically possible.

[0059] FIG. 1 shows a side view of the guide wire 1 according to the present invention, with the distal portion 4 adjacent to the proximal portion 3 along the longitudinal axis 9. The length of the proximal portion 3 (not entirely shown here) clearly exceeds the length of the distal portion 4. The guide wire 1 has a core wire 2, and the diameter of the core wire 2 decreases in the distal portion 4. In the distal region of the core wire 2, a wire coil 5 is fixed, and the total diameter of the guide wire 1 in the distal portion 4 approximately corresponds to that in the proximal portion 3. The proximal portion 3 of the core wire 2 is formed of a cobalt-chromium-nickel-molybdenum alloy, and the distal portion 4 is formed of a superelastic nickel-titanium alloy. The distal portion 4 of the guide wire 1 is provided with a hydrophilic coating 11 on the outside.

[0060] The wire coil 5 consists of two wires 6 extending in a spiral side by side with each other. In this exemplary embodiment, wires 6 with different diameters are used. The thicker wire 6 is formed of a nickel-titanium alloy, and the thinner wire 6 is a platinum wire, and the platinum wire provides radiopacity to the distal portion 4.

[0061] Figure 2 shows a modification of the guide wire 1 according to the present invention corresponding to the basic structure of Figure 1. However, the wire coil 5 here consists of two wires 6 of the same diameter. One wire 6 is also formed of a nickel-titanium alloy in this case, and the other wire 6 is a DFT wire having a radiopaque interior formed of platinum or a platinum alloy and a pseudoelastic sheath formed of nickel-titanium. In addition, a further wire coil 8 is provided inside the wire coil 5. The wire coil 8 extends only over a part of the length of the wire coil 5 and is formed of platinum.

[0062] Figure 3 shows only a part (i.e., the distal part) of the wire coil 5. The wires 6 extending in a spiral side by side are each connected to each other at the paired connection points 7. The offset within each pair of connection points 10 is 45°. The next pair of connection points 10 is arranged with an offset of 440° with respect to the previous pair of connection points 10. Since the offset between the two connection points 7 at this pair of connection points 10 is also 45°, this means that the offset between the first connection points 7 of two consecutive pairs of connection points 10 is also 440°. The same also applies to the offset between the two second connection points 7 of two consecutive pairs of connection points 10. The connection points 7 are usually weld points.

[0063] Overall, in this embodiment, there is a relatively long distance between the pairs of connection points 10, that is, the total number of connection points 7 is relatively small. As a result, a high level of flexibility of the wire coil 5 is obtained, which is particularly desirable in the distal region.

[0064] Figure 4 shows a perspective view of the wire coil from Figure 3. A relatively loose distribution of the connection points 7 can be seen.

[0065] FIG. 5 shows another portion of the wire coil 5. This is likely to be found in the proximal region of the wire coil 5. Here too, the offset between the connection points 7 of the connection point pair 10 is 45°, but the offset between the connection point pairs 10 is much smaller than 130°. Correspondingly, the connection points 7 are arranged closer to each other and have a lower level of flexibility, but higher rigidity and better torque transmission are obtained.

[0066] FIG. 6 shows a perspective view of the wire coil from FIG. 5. A relatively dense distribution of the connection points 7 can be seen.

Claims

1. A guide wire comprising a core wire (2) extending from a proximal end to a distal end, wherein a proximal portion (3) is adjacent to the proximal end and a distal portion (4) is adjacent to the distal end, and the distal portion (4) of the core wire (2) is surrounded by at least one wire coil (5), wherein the wire coil (5) consists of at least two separate wires (6) extending in a spiral shape side by side with each other, and the at least two wires (6) are connected to each other at a plurality of connection points (7) along the wire coil (5), characterized in that it is a guide wire.

2. The guide wire according to claim 1, characterized in that the at least two wires (6) are formed of at least two different materials.

3. The guide wire according to claim 1 or 2, characterized in that the outer diameter of the core wire (2) at the distal portion (4) is smaller than the outer diameter at the proximal portion (3).

4. The guide wire according to any one of claims 1 to 3, characterized in that the connection point (7) is a welded point.

5. The guide wire according to any one of claims 1 to 4, characterized in that the number of connection points (7) along the wire coil (5) decreases from the proximal side to the distal side.

6. The guide wire according to any one of claims 1 to 5, characterized in that the connection points (7) are provided at least partially in pairs.

7. The guide wire according to claim 6, characterized in that the offset between the connection points (7) of the connection point pair (10) is about 180°.

8. The guide wire according to claim 7, characterized in that the offset between the respective first connection points (7) of two consecutive connection point pairs (10) is 15° to 90°, and the respective first connection points (7) are the connection points (7) on the more proximal side of the connection point pair (10).

9. The guide wire according to claim 6, characterized in that the offset between the connection points (7) of the connection point pair (10) is 30 to 60°, preferably about 45°.

10. The guide wire according to claim 9, characterized in that the offset between the respective first connection points (7) of two consecutive connection point pairs (10) is 130° to 440°, and the respective first connection points (7) are the connection points (7) on the more proximal side of the connection point pair (10).

11. The guide wire according to any one of claims 6 to 10, characterized in that the offset between the first connection points (7) of each of two consecutive connection point pairs (10) increases from the proximal side to the distal side.

12. The guide wire according to any one of claims 1 to 11, characterized in that at least one of the wires (6) forming the wire coil (5) is radiopaque.

13. The guide wire according to any one of claims 1 to 12, characterized in that at least one of the wires (6) forming the wire coil (5) is formed of a superelastic alloy or a cobalt-chromium alloy.

14. The guide wire according to any one of claims 1 to 13, characterized in that the pitch of the wire coil (5) decreases from the proximal side to the distal side.

15. The guide wire according to any one of claims 1 to 14, characterized in that the core wire (2) in the proximal portion (3) is at least partially formed of a cobalt-chromium alloy.

16. The guide wire according to any one of claims 1 to 15, characterized in that the core wire (2) in the distal portion (4) is at least partially formed of a superelastic alloy.

17. The guide wire according to claim 16, characterized in that the core wire (2) has a radiopaque interior and has a sheath formed of a superelastic alloy in the distal portion (4).

18. The guide wire according to any one of claims 1 to 14, characterized in that the core wire (2) is formed of a superelastic interior and a sheath of cobalt-chromium or cobalt-chromium-nickel alloy, and the sheath is completely or partially removed in the distal portion (4) of the core wire (2).

19. The guide wire according to any one of claims 1 to 18, characterized in that at least a part of the wire (6) forming the wire coil (5) is twisted.

20. The guide wire according to any one of claims 1 to 19, characterized in that the distal portion (4) of the core wire (2) is surrounded by a plurality of wire coils (5, 8) arranged vertically in the radial direction.

21. The at least two wires (6) forming the wire coil (5) extend in a spiral shape side by side with each other over at least 70%, preferably at least 80%, more preferably at least 90%, and particularly preferably 100% of the total length of the wire coil (5), the guide wire according to any one of claims 1 to 20.