CN114159675A

CN114159675A - Guide wire kit

Info

Publication number: CN114159675A
Application number: CN202010956556.3A
Authority: CN
Inventors: 约翰·威廉·彼得·马尔斯曼
Original assignee: Individual
Current assignee: Individual
Priority date: 2020-09-11
Filing date: 2020-09-11
Publication date: 2022-03-11

Abstract

The present application proposes a guidewire kit comprising a guidewire having a shaft with a curved turnaround section and comprising a straightener defining a lumen for straightening at least the curved turnaround section of the guidewire extending into the lumen for inserting a tip and the curved turnaround section of the guidewire into a needle inserted into a blood vessel of a patient. The length of the straightener is at least 8cm to obtain an improved and more reliable steering action of the curved steering section.

Description

Guide wire suite

Technical Field

The invention relates to a guidewire set.

Background

Guidewires are devices used in many different medical procedures to guide an instrument, such as a vascular catheter, a catheter-mounted heart valve, an intra-aortic graft, an endotracheal tube, or a gastric feeding tube, into a patient toward a desired location within the patient. Guidewires are used in many diagnostic and interventional fields, such as diagnostic and interventional cardiology, diagnostic and interventional neuroradiology, diagnostic and interventional radiology, urology, gastroenterology, vascular surgery, minimally invasive vascular interventions, such as angioplasty, stent implantation, thrombolysis, Transcatheter Aortic Valve Implantation (TAVI), and endovascular abdominal aortic aneurysm repair (EVAR).

When using a conventional guidewire, the physician steers the distal end of the guidewire to a desired location inside the patient's body by gripping and twisting a portion of the shaft section of the guidewire outside the patient's body with his fingers. The function of the shaft is to transmit rotational and longitudinal (axial) forces applied by the physician to a portion of the shaft section of the lead that is outside the patient's body to the distal end of the lead that is inside the patient's body.

In vascular use, a physician needs to navigate a guidewire through the patient's vasculature. This is done to position the distal end of the guidewire at a desired location. In this context, the distal end of the guide wire is the end that enters the body of the patient. The proximal end of the guidewire is not inserted into the patient. The shaft of the guidewire is the section between its proximal and distal ends. Generally, the shaft is only partially inserted into the body, and a portion of the shaft that is not in the body is in the physician's hand.

In other uses, the physician needs to navigate a guidewire through hollow organs, such as the urinary tract, gastrointestinal tract, and bile duct. This is done to position the distal end of the guidewire at a desired location. A diagnostic or therapeutic catheter is then fed over the guidewire to the desired location for the planned intervention (e.g., to dilate a narrowed tube or to perform a stent implantation).

Generally, the distal end of the guidewire has a curved deflection section at its distal end to move the guidewire in a desired direction when advanced into the patient at the bifurcation point or in a particularly curved vessel. The deflecting segment may be curved at a small radius to provide an angled tip oriented at an angle relative to the axis. The shaft and proximal end of the guidewire are straight. Due to the complex anatomy of the vessel and abnormalities in the vessel lumen due to vascular disease, positioning the distal end of the guidewire at the desired location can be difficult and time consuming. The physician manipulates the distal end of the guidewire through the patient's vasculature to the desired location by gripping and twisting the shaft of the guidewire with his fingers.

Because the positioning and steering of the distal end of the guidewire is performed under fluoroscopic guidance, the difficult and time consuming positioning process results in relatively long screening times and, therefore, increases the procedural radiation exposure dose applied to the patient and operator. In particular, in an access procedure (in which a guidewire is inserted into a patient's blood vessel through a needle that passes through the skin to serve as a guide for positioning a flexible introducer having a dilator section and a thin-walled sheath, and in which the operator needs to manipulate the guidewire under fluoroscopic imaging close to the access region), the operator's hands are exposed to a particularly high dose of X-ray radiation.

Many efforts have been made to facilitate navigation of the guidewire tip to a location within the patient. For example, EP 1920795 a1 discloses medical devices, in particular stylets, for insertion into a body cavity, which medical devices have a plurality of curved sections. The curved sections are curved in different planes that intersect each other. The angle between these planes corresponds to the angle between the planes of the corresponding curvilinear bends of the lumen within the patient, so that the stylet can naturally assume a position in which the curved section is located in the corresponding curved portion within the patient and the device does not have to be steered.

EP 1992383 a1 discloses a guidewire with three consecutive bends, the second and third bends being bent in opposite directions to the first and second bends, respectively, making it difficult to mistakenly enter a side branch in a blood vessel.

WO 01/17601 a1 discloses a guiding aid for advancing a tool within a vascular system, the distal part of which has a first and a second curved section and optionally a short straight middle section in between, so that the tip of a guide wire can be guided more easily into a branch with a large and a small vessel diameter.

WO 00/53250 a1 discloses a guide wire prepackaged in a delivery catheter, the distal portion of which extends upwardly in a first direction through the ipsilateral tubular extension of the graft inside the catheter and then downwardly in a second, generally opposite direction into the contralateral tubular extension of the graft. In an untensioned state, the distal portion has (in order from proximal to distal) a straight main portion, a first curved portion, an intermediate portion, and a second curved portion. The first and second portions may have opposite curvatures and may also define different conceptual planes. The middle portion may be straight. The double curvature allows the guidewire to be guided through the contralateral iliac artery and suitably into the contralateral femoral artery as opposed to the femoral artery through which the catheter and guidewire extend into the patient.

Disclosure of Invention

It is an object of the present invention to facilitate steering a guidewire having a curved deflection segment at a distal end to a predetermined location within a patient.

According to the present invention, this object is achieved by providing a guidewire set according to claim 1.

With the kit according to the invention, the risk of accidentally turning the curved deflected section of the guide wire in an unintended direction is significantly reduced, since the straightener is much longer than a conventional straightener. This allows the proximal end of the guide wire (which bends down proximal of the straightener) to more reliably maintain a gap with an underlying surface, such as the surface of a body part of a patient, so that the risk of accidentally applying a laterally directed force on the proximal end portion of the guide wire is reduced. More specifically, in use, the greater length of the straightener causes the proximal end portion of the guide wire to project proximally from the straightener at a relatively high level above the point of entry of the needle into the patient, so that the likelihood of the proximal end of the guide wire contacting the patient is significantly reduced and thus the likelihood of the steering torque exerted by gravity being disturbed is significantly reduced.

In a particular embodiment of the invention, which comprises a kit according to claim 5 and a method according to claim 15, the increased length of the straightener also serves to provide said straightener with a lumen having a curved section, and wherein the curved turning section of the guide wire is at least partly located in the curved section of the lumen of the straightener if the tip protrudes from the straightener over a distance of up to 5-15cm, such that the tip is still in the needle.

When the curved turnaround section of the guidewire is at least partially located in the curved section of the lumen of the straightener, the curvature of the turnaround section causes the guidewire to rotate about its central axis until the curvature assumes a position where the portion of the curved turnaround section of the guidewire within the curved section of the lumen of the straightener is minimally tensioned. Since the curved turning section of the guide wire is at least partly located in the curved section of the lumen of the straightener if the tip is still in the needle, it is ensured that the turning action is already initiated before the tip of the guide wire protrudes from the needle into the blood vessel of the patient. Thus, the deflecting section of the guidewire pushes the tip of the guidewire in substantially the correct direction before the tip exits the needle.

The diverting action of the curved section of the lumen of the straightener can be operated in the same direction as the diverting action of the gravitational force exerted on the curved portion and optionally the more proximal portion of the guide wire protruding proximally from the straightener. However, the curved section of the lumen of the straightener also allows the straightener to be oriented about the needle's centerline for controlled turning of the direction in which the deflecting section deflects the tip. Also, the turning action of the curved section of the lumen of the straightener can be operated in the opposite direction of gravity.

In contrast to conventional guidewires, in the present invention the shaft of the guidewire is not straight over its entire length but has a curved section, thereby providing the shaft with an additional function of facilitating steering of the guidewire to a predetermined location within the patient's body by forces exerted on the guidewire section proximally protruding from the patient, in addition to the conventional function.

The distal curved deflecting section may be deflected in the direction in which the curved deflecting section rotates if the curvature of the distal curved deflecting section and the curvature of the curved deflecting section are in parallel planes, which may be in a single common plane, if the curved deflecting section and the distal curved deflecting section are curved in the same direction, or may be deflected in a direction opposite to the direction in which the curved deflecting section rotates if the curved deflecting section and the distal curved deflecting section are curved in opposite directions.

Specific embodiments of the invention are set forth in the dependent claims.

Further advantages, features and details of the invention will be elucidated on the basis of the description of one or more embodiments with reference to the drawings.

Drawings

Fig. 1 is a schematic cross-sectional view of a first example of a guidewire kit according to the present invention;

FIG. 2 schematically illustrates the relative thicknesses of the core wires of the guidewire of FIG. 1;

fig. 3 is a schematic sagittal cross-sectional view of the guidewire kit of fig. 1 with the tip of the distal end of the guidewire directed upwardly through the blood vessel, wherein;

fig. 4 is a schematic cross-sectional view of a second example of a guidewire kit according to the present invention;

fig. 5 is a schematic sagittal cross-sectional view of the guidewire kit of fig. 4 with the tip of the distal end of the guidewire directed upwardly through the blood vessel;

fig. 6 is a schematic cross-sectional view of a third example of a guidewire kit according to the present invention;

FIG. 7 schematically illustrates the relative thicknesses of the core wires of the guidewire of FIG. 6;

fig. 8 is a schematic front cross-sectional view of the guidewire kit of fig. 6 and 7 with the tip of the distal end of the guidewire directed down the blood vessel; and

fig. 9 is a cross-sectional view of a fourth example of a guidewire kit according to the present invention.

Detailed Description

Fig. 1 to 3 show a first example of a guidewire kit according to the invention. The kit comprises a guide wire 1 and a straightener 14. In fig. 1, the guide wire 1 is shown in an untensioned state, i.e. in a state not subjected to a load that elastically deforms the guide wire 1. In this state, the guidewire 1 has a rounded tip 4 at its distal end with a radius larger than the guidewire circumferential radius. In this example, the rounded tip 4 includes a curved hook section to form a hook that opens in a direction generally toward and along the immediately adjacent section of the guidewire 1 proximal of the rounded tip 4. Alternatively or in addition, the tip 4 may be a soft tip section that is more flexible than the proximal adjacent section of the guidewire. The guide wire 1 also has a curved deflection section 2 which is immediately proximal to the tip 4 and extends at an angle of curvature such that the tip 4 is spaced apart from a continuation 3' of the axis of the shaft section 3 proximal to the curved deflection section 2. The deflecting section 2 is curved in the same direction as the curvature of the rounded tip 4 and has a curvature angle smaller than that forming the rounded tip 4.

In general, the rounded tip section 4 may, for example, have a radius of 1-4 mm. The curved deflecting section 2 may extend, for example, at an angle of 45-165 deg., have a radius of 5-30mm and/or be located at a distance of less than 5-15mm from the proximal end of the tip 4 or directly adjacent to the proximal end of the tip.

The shaft section 3 has a curved turning section 6 proximal to the straight section 5 proximally adjacent to the deflecting section 2 and a further straight section 7 proximal to the curved turning section 6. In fig. 3, the guidewire 1 is shown in a position for introduction through a needle 9 into a blood vessel 10, which is bifurcated into an upper branch 11 and a lower branch 12. In humans, such vascular structures occur, for example, in the groin, where the common femoral artery bifurcates into the superficial and deep femoral arteries.

In this example, the curvature of the curved section 6 of the shaft 3 is oriented such that it has an inner side facing in the direction of curvature opposite to the direction in which the deflecting section 2 deflects the rounded tip section 4 from the continuation 3' of the axis of the shaft section 3. Also, the inner side of the curvature of the curved section 6 of the shaft 3 faces in the same direction as the inner side of the curvature of the tip 4 of the guide wire 1.

Straightener 14 has a tip portion 18, which tip portion 18 is shaped and dimensioned to be inserted into a fitting 19 of needle 9, such that the lumen of needle 9 and the lumen of straightener 14 are positioned adjacent to each other and coaxial to each other. The straightener typically has a tubular main sheath section 52 and the adjacent tip of the straightener typically has a conical section 53 that tapers from the main sheath section 52 to a tubular tip sheath section 54, the tubular tip sheath section 54 having a smaller outer diameter than the main sheath section 52. The diameter of the tip sheath section 54 is arranged to fit tightly in the opening of the fitting of the needle coaxially with the lumen of the needle 9. Preferably, the opening of the needle fitting is conical, tapering inwardly from a first diameter at the proximal end of the needle to a second diameter smaller than the first diameter. The outer diameter of the tip sheath section of the straightener is preferably between the first and second outer diameters of the opening in the fitting of the needle so that a tight coaxial fit in the fitting is ensured.

The straightener of this and other embodiments preferably has a lumen with a diameter that provides a tight sliding fit for a guidewire of approximately 0.014, 0.018, 0.035 inches, or 0.052 inches. The straightener is preferably made of a rigid polymer material, such as PTFE or PA, having a young's modulus of at least 0.3 GPa. In order to obtain a sufficiently rigid straightener, it is also preferred that the straightener has a wall thickness of at least 1 mm. Preferably, the sheath portion has an outer diameter of at least 3mm and more preferably the outer diameter is at least 4 mm. To be compatible with the fitting of a standard needle, the tubular tip sheath section 54 preferably has an outer diameter of 2 mm.

Fig. 3 shows that due to gravity a downward normal force applied to the proximal portion of the turning section 6 and to the straight portion 7 of the shaft 3 of the guide wire 1 causes the shaft portion 3 to rotate into a position in which the curvature of the curved turning section 6 is bent downward in the proximal direction, such that the rotational position of the curvature of the turning section 6 of the guide wire 1 is adapted to the direction in which the turning section is pushed by gravity. If the deflecting section 6 and the deflecting section 2 are offset laterally to some extent by external forces, the tendency of the deflecting section 6 to deflect downwards results in a torque to be applied to the guide wire 1 such that the tip 4 of the guide wire 1 is deflected upwards. Thereby, the tip 4 of the guide wire is turned upwards, which causes the tip 4 of the guide wire to enter the upper branch 11 of the blood vessel 10 when the guide wire 1 is further advanced. As is most common in clinical practice, it is desirable to steer the tip 4 into the superficial femoral artery (represented in fig. 3 by the upper branch 11 of the blood vessel 10), so the guidewire 1 can in principle simply be left to assume the rotational position imposed by gravity as shown in fig. 3, so as to ensure that the guidewire 1 enters the superficial femoral artery effortlessly.

However, in particular when the patient has a relatively high body mass, the abdomen 13 may be relatively higher than the entry point of the needle 9 into the groin 20. In this case, it may easily happen that the proximal end of the guide wire 1 contacts the abdomen 13 of the patient. This tends to offset the proximal end of the guidewire 1 laterally or even upwardly, which in turn diverts the deflecting section 2 laterally or even downwardly so that the tip 4 is not reliably diverted into the superficial femoral artery 11, and increases the likelihood of the tip 4 of the guidewire 1 accidentally entering the deep femoral artery 12.

With the straightener 14 of the kit according to the present embodiment, the risk of accidentally entering the deep femoral artery 12 is significantly reduced, since the straightener 14 has a length of at least 8 cm. Because straightener 14 is much longer than conventional straighteners, the turn section 6 and straight section 7 project proximally from straightener 14 at a much higher level above the entry point of needle 9 into the groin 20 of the patient than when using conventional straighteners, so that the likelihood of the proximal end of guidewire 1 contacting the abdomen 13 of the patient is significantly reduced and thus the likelihood of the turning torque exerted by gravity being disturbed is significantly reduced.

If the kit further comprises a needle 9, the needle 9 defining a lumen 17, the length of the straightener is preferably equal to the sum of the lengths of the round or soft tip 4, the deflecting section 2 and the distal straight shaft section 5 minus the standard length of the puncture needle (10cm) plus about 2-7cm, preferably 3-5 cm. Using such a length ensures that the turning section has partly entered the straightener (over said 2-7cm, preferably 3-5cm) when the tip 4 of the guide wire 1 is located at the needle tip. The curved deflecting section 6 of the guide wire then has applied its deflecting torque before the tip 4 of the guide wire 1 leaves the needle tip, so that when the tip enters the vessel lumen, it has been rotated by the deflecting section 2 and pushed substantially in the desired direction. Furthermore, in this position, the straight section 5 of the guide wire 1 does not protrude from the proximal side of the straightener 14, thus achieving an optimal clearance to the underlying surface (such as the abdomen).

If the straightener 14 is too long, the effect of gravity on the curved turning section ceases while still wishing to ensure that the tip 4 is deflected to the correct direction. Furthermore, the straightener should not be longer than 30-40cm overall for the overall ease of operation, and if the straightener 14 is too short, the purpose of keeping the proximal end of the guide wire 1 free from the patient's abdomen is not achieved or only to a very limited extent. In most practice it is preferred that the length of the straightener is 17-25cm, and more preferably 19-21 cm.

The needle lumen 17, the straightener 14 and the guide wire 1 are preferably sized and shaped for bringing the straightened guide wire 1 to a position extending through the needle lumen 17, wherein the curved turning section 6 is at least partly proximal to the straightener 14 if the tip 4 protrudes from the distal side of the needle 9 over a distance of up to at least 3cm and more preferably up to at least 5 cm. It is thus ensured that the steering effect is maintained also when the tip 4 on the guide wire 1 is advanced a certain distance from the needle 9. If the guide wire 1 is within the indicated range of positions, the length of the portion of the curved turning section 6 located proximal to the straightener 14 is preferably a quarter, and more preferably a third, of the length of the curved turning section 6 measured along the guide wire 1.

The physician only has to advance the guidewire 1 through the needle 9 in order to get the tip 4 of the guidewire 1 into the upper branch 11 of the blood vessel 10. In clinical practice, this means that the physician does not have to divert or rotate the tip 4 of the guidewire 1 from the common femoral artery (represented by the blood vessel 10 in fig. 3) into the superficial femoral artery (represented by the upper branch 11 of the blood vessel 10 in fig. 3), but rather the guidewire 1 enters the superficial femoral artery autonomously.

For this clinical use, the length of the shaft 3 may for example be 30-80cm or 45-65cm, e.g. 55cm, and the length of the curved steering section 6 of the shaft 3 may for example (for increased preference) be 5-65cm, 11-60cm or 20-55cm, e.g. 40cm, to achieve a sufficiently strong steering effect over a sufficiently large insertion depth range where the tip may be close to the bifurcation of the femoral artery where steering in the correct direction is required, while also allowing the curved steering section to easily bend into a straight configuration during and after insertion of the distal curved steering section into the patient.

To easily accommodate straight shapes and manipulation of the guidewire, in the untensioned state, the turning section 6 preferably has a larger radius of curvature than the deflecting section 2, the radius of curvature of the turning section 6 preferably being at least two, three or four times as large as the radius of curvature of the deflecting section.

The length of the distal straight section 5 may for example be 2-6cm or 3-5cm, e.g. 4cm, so that the tip 4 of the guidewire 1 is near the bifurcation when the steering effect of the curved steering section is most pronounced. To allow steering over a large range of insertion depths, the length of the distal straight section 5 that transfers the steering action from the curved steering section 6 to the curved deflecting section 2 is preferably greater than 6cm, or to increase the degree of preference, at least greater than 7cm, 9cm, 11cm or 13 cm. The length of the distal straight section 5 is preferably no greater than 55cm for ease of steering operation and immediacy, or 40cm, 35cm, 25cm or 20cm for increased preference.

The length of the proximal straight section 7 may for example be 2-8cm, for example 4cm, to provide a straight proximal end. The length of the proximal straight section 7 is preferably at least 6cm for increased versatility and catheter exchange, or at least 7, 9, 11 or 13cm for increased preference. For ease of handling, the length of the proximal straight section 7 is preferably no more than 55cm, or for increasing preference no more than 40cm, 35cm, 25cm or 20 cm.

As described in WO 2008/013441, the deflection section 2 of the guide wire 1 may for example be curved. The maximum distance 8 of the curved section 6 of the shaft 3 from a straight line between the ends of the curve may measure, for example, 5-12cm or 7-10cm, for example 8cm, and the angle of curvature between the opposite ends of the curved section 6 may be, for example, 15-45 ° or 20-40 °, for example 30 °, to achieve a steering effect of sufficient magnitude without compromising the overall ease of guidewire handling.

In this example, the guidewire 1 has a core wire and a spring wire extending helically around the core wire, as is common in prior art guidewires. Fig. 2 shows by way of example the relative thickness of the core wire in the

various segments

2, 5, 6 and 7 of the guide wire 1. If the relative thickness of the curved section 6 is 100%, the relative thickness of the proximal and distal

straight sections

5, 7 may for example be 60% -90%, for example 75%, and the relative thickness of the distal end 2 of the guidewire 1 may for example be 30% -60%, for example 50%. Thus, the curved turning section 6 is relatively stiff, so that the small deflection provided by the curved turning section 6 is sufficient for direct and precise turning of the distal sections 2 and 4. The core is preferably a shape memory alloy, such as nickel titanium (also known as nitinol or NiTi).

In general, thicker cords are stiffer than thinner cords. In the deflecting section 2 and tip 4 of the guidewire 1, the core wire has the smallest thickness, so that this section is the most elastic and well suited to the shape of the lumen of the vessel in which it is inserted. The deflecting section 2 should be sufficiently flexible to prevent any injury that may be applied by the tip 4 of the guidewire 1.

In this example, the core wire of the curved turning section 6 of the shaft section 3 has a thickness that is greater than each of the thicknesses of the core wire in the proximal straight section 7 and the deflection section 2, which makes this section stiff enough to impose the direction of curvature of the curved turning section 6, even though the turning section 6 would bend upward in the proximal direction away from the needle 9 in the unloaded state. Thus, if the guide wire is released and the curvature of the curved turning section 6 is pushed downwards by gravity, the gravity rotates the guide wire 1 particularly reliably. This rotation, in turn, turns the tip portion 4 of the guide wire 1 to an upwardly deflected orientation, and then advancement of the guide wire causes the tip section 4 to enter the upper branch 11 of the blood vessel 10, as shown in fig. 3.

The core wire of the distal straight section 5 of the guidewire 1 according to the present example has a distal portion 50 with an intermediate thickness that is less than the thickness of the core wire in the turnaround section 6 and greater than the thickness of the core wire in the deflection section 2. In this example, the core wire in the proximal straight section 7 has a thickness that is approximately the same as the thickness of the core wire in the distal portion 50 of the distal straight section 5, but the thickness may also be the same as the thickness of the core wire in the curved turnaround section 6. Thus, the stiffness of the distal portion 50 of the distal straight section 5 is centered, which facilitates accurate transmission of the rotational orientation of the curved turning section 6 to the curved deflecting section 2 of the guidewire 1. The tissue between the skin surface of the groin 20 and the lumen of the blood vessel 10 is sometimes thicker due to obesity and/or structurally denser, for example due to prior surgical scarring. As in the present example, it is advantageous if the straight section 5 also comprises a proximal portion 51 having a stiffness exceeding the stiffness of the turning section 6. To this end, the core wire in the proximal portion 51 of the distal straight section 5 may for example have a thickness of 105% -145%, for example 120%, relative to 100% of the thickness of the core wire in the section 6. The length of the proximal portion 50 and the distal portion 51 is preferably 25% and 75% of the length of the distal straight section 5, respectively. The stiffness of the proximal straight section 7 of the guidewire 1 according to the present example is also central, which facilitates easy insertion of the proximal end of the guidewire into a port of a catheter or the like to be guided over the guidewire to a desired intravascular location. Also, the proximal end of the guidewire is not too stiff for use of the guidewire from posterior to anterior in selected circumstances to traverse a tight obstruction in a blood vessel with the proximal end of the guidewire.

In fig. 4 and 5, a second example of a guidewire kit according to the present invention is shown. In general, the degrees of preference regarding the shape and size of the guidewire 1 shown in fig. 1 to 3 also apply to the guidewire 1 according to the present example. In this example, straightener 34 has a lumen 35 with a curved section 36. Similar to straightener 14 of figures 1 and 3, straightener 34 has a tip portion 38 shaped and dimensioned to be inserted into fitting 19 of needle 9 such that the lumen of needle 9 and the lumen of straightener 34 are positioned adjacent to each other and coaxial with each other. The diameter of the lumen of the straightener is preferably the same as or slightly smaller than the lumen of the needle, so that the tip of the guide wire has no resistance to passing through the junction between the lumen of the tip of the straightener and the lumen of the metal part of the needle, while the plastic fitting 19 of the needle has a considerable entrance diameter to facilitate the introduction of the straightener into the fitting of the needle.

If the tip 4 of the guide wire protrudes from the straightener 34 over a distance in the range between 5 and 15cm and preferably in the range up to 10cm, which is the standard length of the needle via which the guide wire is introduced during entry, the curved turning section 6 of the guide wire 1 is at least partly located in the curved section 36 of the lumen 35 of the straightener 34. Thus, when the tip 4 emerges from the needle 9, the curved turning section 6 of the guidewire 1 is at least partially located in the curved section 36 of the lumen 35 of the straightener 34.

When the curved turnaround section 6 of guidewire 1 is at least partially located in the curved section 36 of lumen 35 of straightener 34, the curvature of turnaround section 6 causes guidewire 1 to rotate about its central axis until the curvature assumes a position where the portion of curved turnaround section 6 of guidewire 1 within the curved section 36 of lumen 35 of straightener 34 is least tensioned. Because the curved turning section 6 of the guide wire 1 is at least partially located in the curved section 36 of the lumen 35 of the straightener 34 if the tip 4 is at the distal end of the needle, the turning action starts before the tip emerges from the needle 9, thus ensuring that the deflecting section 2 pushes the tip 4 in a substantially correct direction before the tip 4 starts to protrude from the needle into the patient's blood vessel.

In this example, the length of straightener 34 proximal to the curved section 36 of lumen 35 of straightener 34 is preferably at least equal to the sum of the lengths of the round or soft tip 4, the deflecting section 2 and the distal straight section 5 minus the standard length of the puncture needle (10cm), plus about 3-5 cm. Using such a length ensures that the turning section 6 has partly entered the curved section 36 of the lumen 35 of the straightener 34 (over the said 3-5cm) when the tip 4 of the guide wire 1 is located at the distal needle tip. Then, before the moment when the tip 4 of the guidewire 1 leaves the needle tip, the curved turning section 6 of the guidewire is pushed to the desired position by the curved section 36 of the lumen 35 of the straightener 34, so the tip 4 of the guidewire 1 has been rotated as it enters the vessel lumen and is pushed into the substantially desired direction by the deflecting section 2. If the straightener 14 is too long, the steering action of the

curved sections

6, 36 may cease while still wishing to ensure that the tip 4 is deflected to the correct direction. If the straightener 14 is too short, the steering action will only start or the magnitude of the steering action will be too limited after the tip 4 of the guide wire 1 emerges from the needle. In most practice, the length of the straightener is preferably 17-25cm, and more preferably 19-21 cm.

If the curved section 36 of the lumen 35 of the straightener 34 is bent down in the proximal direction and the part of the curved turning section 6 of the guide wire is located a short distance inside the straightener 34, the turning action of the curved section 36 of the lumen 35 of the straightener 34 can be operated in the same direction as the turning action of the gravity force applied to the straight section 7 and the part of the turning section 6 still protruding proximally of the straightener 34, so the turning action of the curved section 36 of the lumen 35 of the straightener 34 and the turning action of the force applied by the gravity can be operated in unison. However, the curved section 36 of the lumen 35 of the straightener 34 also allows the straightener 34 to rotate about the centre line of the needle 9 for controlled steering of the direction in which the deflecting section 2 deflects the tip 4. In the dotted line, the straightener 34 is shown in an orientation: wherein the curved section 36' of the lumen of the straightener 34 has been rotated 180 ° around the centre line of the needle 9 for a controlled steering of the tip 4 into the lower branch 12 of the blood vessel 10. By rotating the straightener 34 around the centre line of the needle 9, the curved turning section 6' of the guide wire 1 is also rotated and thus the deflection section 2' is entrained and the direction of deflection of the tip 4' is rotated into the deep femoral artery. Thus, the straightener can also be used for torque steering of the guide wire 1.

If the kit further comprises a needle 9, the needle 9 defining a lumen 17, the needle lumen 17, the straightener 34 and the guide wire 1 are preferably sized and shaped for bringing the straightened guide wire 1 into a position extending through the needle lumen 17, wherein in at least one position of the guide wire 1 (wherein the tip 4 is distal to the needle 9 or protrudes distally from the needle 9) the curved turning section 6 is at least partially located in a curved portion 36 of the lumen 35 of the straightener 34.

For a particularly positive and reliable steering action, it is preferred that in any position of the guide wire 1, in which the tip 4 projects from the distal side of the needle 9 over a distance of up to at least 3cm and preferably up to at least 5cm, the curved portion 6 of the guide wire 1 is at least partially located in the curved section 36 of the lumen 35 of the straightener 34. It is thus ensured that steering is also maintained when the tip 4 of the guidewire 1 is advanced beyond a certain clinically useful distance from the needle 9.

If the tip 4 of the guide wire is in the described position, the length of the part of the curved turning section 6 that is located in the curved section 36 of the lumen 35 of the straightener 34 is preferably at least a quarter and more preferably at least a third of the length of the curved turning section 6 measured along the guide wire 1.

For a strong steering and prolonged steering action when the guide wire is advanced into the patient, it is also advantageous if the curved section 36 of the lumen 35 of the straightener 34 is shorter than the steering section 6 of the guide wire 1 and if the curved section of the lumen of the straightener has a radius of curvature which is smaller than the radius of curvature of the curved steering section 6 of the guide wire 1 in the untensioned state.

Fig. 6 and 8 show front cross-sectional views of a third example of a guidewire kit according to the invention. The guide wire 21 has a bend deflection section 22 and a shaft section 23 and extends through the straightener 34. The straightener 34 may be the same as the straightener 34 shown in figures 4 and 5, but may also have different dimensions to accommodate the different clinical uses for which it is intended.

The deflection section 22 of the guidewire 21 has a tip 24. The shaft section 23 of the guidewire 21 has a distal linear section 25, a proximal linear section 27, and a curved steering section 26 between the distal and proximal linear sections. The curvature of the curved section 26 of the shaft 23 is curved in the same plane and into the same direction of curvature as the curvature of the curved turning section 22 of the guide wire 21.

The length of the shaft section 23 may be, for example, 100-230cm, for example 160cm, and the length of the curved section 26 of the shaft 23 may be, for example, 5-65cm or 20-55cm, for example 40 cm. The length of the proximal linear section 27 may be, for example, 65-110cm, for example 85cm, and the length of the distal linear section 25 may be, for example, 15-80cm or 30-55cm, for example 35 cm. The deflecting section 22 of the guide wire 1 may for example be curved as described in WO 2008/013441. The maximum distance 28 of the curved section 26 of the shaft section 23 from a straight line between the ends of the curved section 26 may measure, for example, 5-12cm or 7-10cm, e.g., 8 cm.

The guide wire 21 has a core wire and a spring wire. Fig. 7 schematically shows the relative thicknesses of the core wires in the various segments of the guidewire 21, which may also be similar to the example of fig. 2.

Fig. 8 shows the guide wire 21 in a position for introduction of a vascular structure through the needle 9, which is schematically representative of the vascular structure of a human breast (see front view). Analogous to the thoracic anatomy, the needle 9 has been introduced into the right subcutaneous vein 31.

If the tip 24 is extended from the needle 9, the curved turnaround section 26 of the guidewire 21 is at least partially located in the curved section 36 of the lumen 35 of the straightener 34. When the curved turnaround section 26 of the guidewire 1 is at least partially located in the curved section 36 of the lumen 35 of the straightener 34, the curvature of the turnaround section 26 causes the guidewire 21 to rotate about its central axis until the curvature assumes a position where the portion of the curved turnaround section 26 of the guidewire 21 inside the curved section 36 of the lumen 35 of the straightener 34 is least tensioned. If the inside of the curvature of the curved section 36 of the lumen 35 of the straightener 34 faces the direction of the patient's feet with the patient in the prone position and a portion of the curved turning section 26 of the guide wire is at least partially located in the curved section 36 of the lumen 35 of the straightener 34, the turning action of the curved section 36 of the lumen 35 of the straightener 34 pushes the inside of the curvature of the deflecting section 22 in the direction of the patient's feet, thereby deflecting the tip 24 also in the direction of the patient's feet. However, the curved section 36 of the lumen 35 of the straightener 34 also allows the straightener 34 to rotate about the centre line of the needle 9 for controlled torque steering of the guide wire, thereby steering the direction in which the tip 24 is deflected by the deflecting section 22.

Since the curvature of the steering section 26 and the curvature of the deflection section 22 and, correspondingly, the tip 24 of the guidewire, are in the same direction, the deflection section 22 deflects the tip 24 into the direction of the superior vena cava 32 if the steering section is bent downward. At the same time, the tip 24 of the guidewire is deflected away from the entrance to the left internal jugular vein 33. In clinical practice, in examinations where a central venous catheter is placed, it is important to point the guide wire down to the superior vena cava because the desired location of the central venous catheter fed over the guide wire is in the superior vena cava. However, misplacement of a central venous catheter in the ipsilateral internal jugular vein is a common complication. See muckshiri (Mukesh Tripathi) in anesthesia Analgesia (Analgesia), 2005, vol 100, page 21, "direction of J-shaped tip of guidewire in femoral artery puncture procedure" is an important factor for misplacement of subclavian venous catheters: random controlled study (guidance of the J-tip of the guideridwire, in Seldinger technique, is a significant factor in miralactice of Subclaviran vessel: a randomised, controlled study). Figure 8 shows that the inside of the curved turning section 26 of the guide wire 21 is forced into the same direction of the main axis of extension of the patient's body as the inside of the curvature of the curved section 36 of the lumen 35 of the straightener 34. This allows the physician to steer the distal tip 24 of the guide wire away from the right internal jugular vein 33, not by rotating the guide wire about its central axis, but by maintaining the straightener 34 in an orientation where the curved section 36 of the lumen 35 of the straightener 34 curves towards the patient's foot in the direction of the main axis of extension of the patient's body. In fact, the physician does not even have to keep the straightener in this particular orientation, but only has to ensure that the straightener rests more or less horizontally on a substantially flat area around the shoulders of the patient (aseptically covered) when the patient is lying down in the usual prone position. Therefore, complications of misplacement of the central venous catheter in the right internal jugular vein can be reliably prevented in a simple manner.

In fig. 9, a guide wire kit with a guide wire 61 and a straightener 74 according to a fourth example of the invention is shown. The curved section 76 of the lumen of the straightener 74 is curved at an angle of about 150 ° off from straight, which provides a particularly positive steering action. To this end, preferably, the angle of deflection of the curved section 76 of the lumen of the straightener 74 from a straight line is at least 45 °, and more preferably, at least 90 ° or at least 120 °. At larger deflections in the rear, a practically useful steering effect can also be achieved if a straight guide wire is used.

The present invention has been described above based on several preferred embodiments. Different aspects of the different embodiments may be combined, depending on the envisaged application. This includes all combinations that the skilled person can make on the basis of this document. These preferred embodiments do not limit the scope of protection of this document. The rights sought are defined in the claims below.

All references, including publications, patent applications, and patents, cited herein are hereby incorporated by reference to the same extent as if each reference were individually and specifically indicated to be incorporated by reference and were set forth in its entirety herein.

The use of the terms "a" and "an" and "the" and "at least one" and similar referents in the context of describing the invention (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. The use of the term "at least one" (e.g., "at least one of a and B") following a list of one or more items should be construed to mean one item selected from the listed items (a or B) or any combination of two or more of the listed items (a and B), unless otherwise indicated herein or clearly contradicted by context. The terms "comprising," "having," "including," and "containing" are to be construed as open-ended terms (i.e., meaning "including, but not limited to,") unless otherwise noted. Recitation of ranges of values herein are merely intended to serve as a shorthand method of referring individually to each separate value falling within the range, unless otherwise indicated herein, and each separate value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., "such as") provided herein, is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention unless otherwise claimed. No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the invention.

Preferred embodiments of this invention are described herein, including the best mode known to the inventors for carrying out the invention. Variations of those preferred embodiments may become apparent to those of ordinary skill in the art upon reading the foregoing description. The inventors expect skilled artisans to employ such variations as appropriate, and the inventors intend for the invention to be practiced otherwise than as specifically described herein. Accordingly, this invention includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is encompassed by the invention unless otherwise indicated herein or otherwise clearly contradicted by context.

Claims

1. A guide wire kit, comprising:

A guide wire for guiding a catheter or catheter introducer sheath into a human patient, when in an untensioned state, the guide wire having:

- a rounded tip or soft tip section at the distal end of the guide wire, the radius of the round tip being larger than the guide wire circumference radius, the soft tip section being larger than the proximal side of the guide wire The adjacent segment is more flexible;

- a curved deflection section immediately proximal of the tip; and

- a shaft section located proximal of the curved deflection section;

wherein the curved deflection section extends at an angle of curvature such that the tip is spaced from a continuation of the axis of the shaft section; and

wherein the shaft section has a straight section proximal to the adjacent deflection section and a curved turn section proximal to the straight section; and

a straightener defining a lumen for straightening at least the curved deflection section of the guidewire extending into the lumen to connect the tip of the guidewire and the the curved deflection section is inserted into a needle inserted into a blood vessel of a patient;

Wherein, the length of the straightener is at least 8 cm.

2. The kit of claim 1, further comprising a needle defining a lumen having a length, the needle lumen and the guide wire sized to bring the guide wire into extending through the needle The position of the lumen, the length of the straightener is equal to the sum of the lengths of the rounded tip or the flexible tip, the deflection section and the distal straight shaft section minus the needle lumen Length plus 2cm to 7cm.

3. The kit of claim 1 or 2, further comprising a needle defining a lumen, the needle lumen and the guide wire sized to bring the guide wire into extending through the needle lumen position, wherein if the tip of the guide wire protrudes more than up to at least 3 cm distally from the needle, the curved turning section of the guide wire is located partially proximal to the straightener the proximal side of the end.

4. The kit of any one of claims 1 to 3, wherein the straightener has a straight lumen.

5. The kit of claim 1, wherein the straightener lumen has a curved section, and wherein if the tip of the guidewire protrudes from the straightener more than 5 cm to 15 cm at least one distance in the range between, the curved turning section of the guide wire is located at least partially within the curved section of the lumen of the straightener.

6. The kit of claim 5, further comprising a needle defining a lumen, the needle lumen and the guide wire sized to bring the guide wire into position extending through the needle lumen , wherein, if the tip of the guide wire is at the distal end of the needle, the curved turning section of the guide wire is at least partially located in the lumen of the straightener in the curved section.

7. The kit of claim 5 or 6, further comprising a needle defining a lumen, the needle lumen and the guide wire sized to bring the guide wire into extending through the needle lumen position, wherein if the tip of the guide wire protrudes more than up to at least 3 cm distally from the needle, the curved turning section is located at least partially within the lumen of the straightener in the curved section.

8. The kit of any one of claims 1 to 7, wherein the curved section of the lumen of the straightener is shorter than the diverted section of the guidewire.

9. The kit of any one of claims 5 to 8, wherein, in the untensioned state, the radius of curvature of the curved section of the lumen of the straightener is smaller than the The radius of curvature of the steering section of the guide wire.

10. The kit of any one of claims 5 to 9, wherein the curved section of the lumen of the straightener is curved at an angle of at least 45° from a straight line.

11. The kit of any one of claims 1 to 10, wherein, in the untensioned state, the diverted section of the guide wire forms a bend, the bend and the The maximum distance between the straight lines between the ends of the bends is 5 cm to 12 cm.

12. The kit of any one of claims 1 to 11, the guide wire further having a core wire of shape memory alloy and a spring wire extending helically around the core wire.

13. The kit of any one of claims 1 to 12, the guide wire having a core wire having a first thickness in the bend deflection section and a first thickness in the shaft section another thickness greater than the first thickness.

14. A kit according to claim 12 or 13, wherein in the curved turning section of the shaft section the core has a thickness greater than the thickness of the first portion of the straight section and A thickness that is less than the thickness of the second portion of the straight section.

15. A method for advancing a guidewire into a patient through a lumen of a needle inserted into a human patient using a straightener having a lumen, at least a portion of the lumen of the straightener being curved ;

Wherein, when in an untensioned state, the guide wire has:

- a rounded tip or soft tip section at the distal portion of the guide wire, the round tip having a radius greater than the guide wire circumference radius, the soft tip section being more proximal than the guide wire Adjacent sections are more flexible;

- a curved deflection section immediately proximal of the tip; and

- a shaft section located proximal of the curved deflection section;

The method includes the following steps:

straightening the distal portion and the deflected section of the guidewire in the straightener;

positioning the straightener in alignment with the proximal end of the needle;

advancing the guidewire, wherein the distal portion enters the lumen of the needle; and

The straightener has a curved section that is at least partially located in a portion of the curved portion of the straightener by being external to the patient at a curved steering section of the guidewire A steering torque is applied to steer the deflection section.