Guide wire

Abstract

The present invention relates to a guidewire 10 for placing a medical device into a body of a patient, the guidewire 10 comprising an elongate body 12 having a distal axial end 14 and a proximal axial end 16. The elongate body 12 includes a first portion 18 having a first stiffness and a second portion 20 having a second stiffness. A first stiffness of the first portion 18 is different from a second stiffness of the second portion 20.

Description

Technical Field

[0001] The present invention relates to a guidewire for placing a medical device into the body of a patient. Background Art

[0002] Medical devices (such as intravascular blood pumps, intracardiac blood pumps or catheters) can be introduced into the patient's body in various ways. Such medical devices are usually introduced surgically or subcutaneously during cardiac procedures through the vascular system. In a common method, a guide wire is used to insert the medical device through the femoral artery or axillary artery. The guide wire can be inserted into the corresponding artery through an arteriotomy to produce an insertion path for the medical device. Therefore, the guide wire advances through the corresponding artery until the far axial end of the guide wire is respectively deployed in the left ventricle or the right ventricle. Then, a part of the medical device advances along the guide wire until it is correctly placed in the corresponding ventricle. Once the medical device has been inserted, the guide wire is removed from the patient's body.

[0003] Further, in the case where the placed medical device needs to be replaced, the guidewire is advanced again along the medical device to be replaced until its distal axial end is correctly positioned in the patient's heart. Afterwards, the medical device is removed from the patient's body, wherein the guidewire remains stationary. Then, the new medical device is advanced along the guidewire as described above.

[0004] In the case where the medical device is a blood pump, different types are known from the prior art and are intended to support the function of the patient's heart in short-term applications (wherein the blood pump is placed in the patient's body for several days or weeks) or in long-term applications (wherein the blood pump is placed in the patient's heart for several weeks or months).

[0005] In general, a blood pump is intended to remove blood from a patient's heart into blood vessels to provide hemodynamic support. When placed in the left ventricle of a patient's heart, the blood pump pumps blood (e.g., from the left ventricle of the heart) and delivers the blood to, for example, the aorta. When placed in the right ventricle of a patient's heart, the blood pump pumps blood from the lower great veins, bypasses the right atrium and right ventricle, and delivers the blood to the pulmonary artery.

[0006] During a planned procedure, fluoroscopy may be used to introduce a guidewire into the patient's body to ensure correct positioning of the guidewire, and therefore the medical device, in the patient's heart. Typically, X-rays are used for fluoroscopy.

[0007] However, fluoroscopy, especially fluoroscopy using X-rays, has certain limitations and side effects. During planned surgeries for placing a blood pump or a guidewire, respectively, X-rays cannot be used without restriction. In addition, patients and doctors are exposed to high amounts of radiation when performing X-rays. When an emergency occurs where a medical device must be introduced immediately into a patient's body, X-rays are generally not available, for example, in an intensive care unit or an ambulance.

[0008] In addition, correctly placing the distal axial end of the guidewire in the patient's heart requires some practice and interventional skills of the doctor. Specifically, it is necessary to ensure that the guidewire will not puncture a blood vessel during placement, nor enter an unintended blood vessel, such as a coronary artery.

[0009] Therefore, there is a need to provide an improved guidewire to facilitate placement of a medical device into a patient's body. Summary of the invention

[0010] According to a first aspect, a guidewire for placing a medical device into a patient's body comprises an elongated body having a distal axial end and a proximal axial end. The elongated body comprises a first portion having a first stiffness and a second portion having a second stiffness. The first stiffness of the first portion is different from the second stiffness of the second portion.

[0011] Therefore, the first stiffness of the first portion can be selected to be sufficiently flexible to ensure that puncture of a blood vessel is inhibited. Further, the first stiffness of the first portion can be selected to be suitable for passing through, for example, an aortic valve when the guide wire is introduced into the patient's body. The second stiffness of the second portion can be selected to be sufficiently hard for delivering a medical device and advancing the guide wire in the patient's body.

[0012] Preferably, the first portion extends from the distal axial end to the direction of the proximal axial end. The second portion can be adjacent to the first portion, and can extend in the direction of the proximal axial end. The second portion can be directly adjacent to the first portion, or can be adjacent to the first portion. Therefore, the term "adjacent (adjacent)" does not mean that there is direct contact between the first portion and the second portion, but the middle portion can be between the first portion and the second portion. Therefore, the first portion can be the tip portion of the guide wire, and the second portion can constitute the rest of the guide wire. Of course, the third portion with a stiffness different from the first portion and / or the second portion can be arranged to be adjacent to the second portion extending in the direction of the proximal axial end.

[0013] Preferably, the first stiffness comprises a first axial stiffness and the second stiffness comprises a second axial stiffness, wherein the first axial stiffness is different from the second axial stiffness. This ensures that a suitable stiffness can be selected for the first portion to prevent puncturing of a blood vessel. On the other hand, sufficient stiffness can be selected for the second portion to allow force transmission to push the guidewire forward.

[0014] Preferably, the first axial stiffness is less than the second axial stiffness. Therefore, the first axial stiffness can be in the range of 1.4mN / mm to 30mN / mm. The second axial stiffness can be in the range of 1.4mN / mm to 30mN / mm. The second axial stiffness is high enough to allow the guide wire to be pushed forward without the risk of forming a waveform. The first axial stiffness is low enough to prevent puncturing a blood vessel while pushing the guide wire forward. Alternatively, the first axial stiffness is substantially equal to the second axial stiffness.

[0015] Preferably, the first stiffness comprises a first transverse stiffness, and the second stiffness comprises a second transverse stiffness, wherein the range of the first transverse stiffness is different from the range of the second transverse stiffness. Preferably, the range of the first transverse stiffness is 20mN / mm to 3.00N / mm, preferably 30mN / mm to 2.30N / mm, and more preferably 39mN / mm to 2.28N / mm. Preferably, the range of the second transverse stiffness is 1.00N / mm to 3.50N / mm, preferably 1.50N / mm to 3.00N / mm, and more preferably 1.75N / mm to 2.28N / mm. This ensures a sufficiently high degree of bending ability and further reduces the risk of puncturing a blood vessel when the guidewire is pushed forward.

[0016] The first portion preferably has an axial extension of up to 15 cm.The total axial extension between the distal axial end and the proximal axial end is preferably in the range of 120 cm to 260 cm.

[0017] Preferably, the first portion includes an anti-damage tip extending from the distal axial end. The anti-damage tip is preferably a J-shaped tip. The radius of the J-shaped tip is preferably selected to be large enough not to enter an unexpected blood vessel (e.g., a coronary artery) when the guidewire is pushed forward. Therefore, the anti-damage tip preferably has an axial stiffness in the range of 1.4mN / mm to 30mN / mm, and preferably has a transverse stiffness of 39mN / mm to 353mN / mm.

[0018] Here, when the first axial stiffness and / or the first lateral stiffness are set within the range according to the present disclosure and / or the atraumatic tip is provided, there is no need to provide a pigtail at the distal axial end of the guidewire to pass through the aortic valve.

[0019] The guidewire may include a sensor, wherein the sensor may be arranged in or close to the first part, wherein the sensor may preferably be arranged in the region between the anti-damage tip and the second part. Alternatively, the sensor may be integrated in the anti-damage tip. The sensor is preferably a tracking sensor. Preferably, the sensor is an electromagnetic tracking sensor. Therefore, the position of the sensor in the patient's body can be tracked by using a suitable tracking device (e.g., an electromagnetic field generator), and therefore also the first part of the guidewire. This provides further assistance for the doctor when the guidewire is placed in the patient's body. Preferably, the guidewire further includes a lead assembly. The lead assembly may be attached to the sensor, and the lead assembly may extend in the axial direction to the proximal axial end of the body. The signal of the sensor may be transmitted or transferred using the lead assembly, respectively.

[0020] Preferably, the body includes a hollow portion, and the lead assembly may be disposed in the hollow portion. The lead assembly is fastened in the hollow portion of the body and may not tear due to bending or jamming.

[0021] Preferably, the main body may include a stabilizing coil, wherein the lead assembly is wound in parallel with the stabilizing coil. This also inhibits tearing of the lead assembly.

[0022] Preferably, the sensor is arranged in a magnetically permeable housing, the housing preferably comprising a plastic material. The housing protects the sensor from damage and further allows signal continuity.

[0023] Alternatively, the sensor may be disposed within a protective layer, preferably an extruded protective layer or coating. The protective layer is preferably magnetically permeable. The protective layer protects the sensor from damage and further allows continuity. Further, the entire body of the guidewire may be coated with the protective layer.

[0024] The guide wire may include at least one other sensor. The at least one other sensor may be arranged at a specific distance from the distal end to the proximal end, or may be arranged at a specific distance from the sensor in the region between the anti-damage tip and the second portion or may be arranged in the anti-damage tip. Preferably, the specific distance may be 10 cm. The guide wire may include a plurality of sensors distributed along the guide wire. The plurality of sensors may be spaced equidistantly from each other in the axial direction, for example, at a specific distance. The plurality of sensors may also be spaced unequally from each other in the axial direction.

[0025] Preferably, the sensor comprises a measuring coil, wherein the measuring coil is directly wound around a portion of the guide wire, preferably around a portion of the body, preferably around the hollow portion of the body. More preferably, the at least one further sensor comprises a measuring coil, wherein the measuring coil is directly wound around a portion of the guide wire, preferably around a portion of the body, preferably around the hollow portion of the body. This can also be done at several positions of the guide wire. Further, the integral part is then covered to prevent the lead assembly from rupturing. Preferably, the body comprises at least one cardiac echo marker. This allows the position of the guide wire to be tracked by medical ultrasound or sonography.

[0026] The medical device according to the present disclosure may correspond to the aforementioned intravascular blood pump, intracardiac blood pump, or catheter. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] The above summary of the invention and the following detailed description of preferred embodiments will be better understood when read in conjunction with the accompanying drawings. For the purpose of illustrating the present disclosure, please refer to the accompanying drawings. However, the scope of the present disclosure is not limited to the specific embodiments disclosed in the accompanying drawings.

[0028] In the attached picture:

[0029] [ Figure 1 ] shows a schematic side view of a guidewire according to a first embodiment;

[0030] [ Figure 2 ] shows a schematic side view of a guidewire according to a second embodiment;

[0031] [ Figure 3 ] shows a schematic side view of a guidewire according to a third embodiment; and

[0032] [ Figure 4 ] shows a schematic side view of a guidewire according to a fourth embodiment. DETAILED DESCRIPTION

[0033] Figure 1 A schematic side cross-sectional view of a guidewire 10 for placing a medical device in a patient's body according to a first embodiment is shown. The guidewire 10 comprises an elongated body 12 having a distal axial end 14 and a proximal axial end 16. The body 12 has an almost cylindrical shape and a total length of 120 cm to 260 cm, i.e., a total axial extension between the distal axial end 14 and the proximal axial end 16 of 120 cm to 260 cm.

[0034] The body 12 has a first portion 18 extending from the distal axial end 14 toward the proximal axial end 16 and a second portion 20 extending from the distal end of the first portion 18 to the proximal axial end 16. The first portion 18 has a total length of 15 cm and includes an atraumatic tip 22 in the form of a J-shaped tip. The J-shaped tip 22 has a length of about 8 cm. Figure 1 The J-shaped tip 22 may be made of a plastic material or a metal coil. The boundary between the first portion 18 and the second portion 20 is defined by Figure 1 The J-shaped tip 22 ensures that the guidewire 10 will not enter small blood vessels (such as coronary arteries) when being pushed toward the patient's body or heart, respectively. Therefore, the diameter of the J-shaped tip 22 must be large enough not to enter the coronary arteries.

[0035] The guidewire 10 may have an outer diameter of 0.025" (about 0.0635 cm) or less and have an outer sheath 38 made of a highly biocompatible plastic material such as PTFE or any other hydrophilic material. The outer sheath 38 defines a hollow portion 28 within the body 12 of the guidewire 10.

[0036] The sensor 24 is disposed in the hollow portion 28 of the body 12. Specifically, the sensor 24 is disposed in the first portion 18, in a region between the end of the J-shaped tip 22 and the end of the first portion 18, ie, in a region 8 to 15 cm from the distal axial end 14.

[0037] Lead assembly 26 is attached to sensor 24 and extends to proximal axial end 16 in hollow portion 28. For simplicity, lead assembly 26 is shown as a line, but it can include two or more twisted or untwisted leads. In addition, lead assembly 26 can be covered or coated with, for example, a PTFE coating. Sensor 24 can be an electromagnetic tracking sensor, and the position of sensor 24 can be tracked by a suitable device (e.g., an electromagnetic field generator). Sensor 24 can be a sensor that supports position measurement with six degrees of freedom or with five degrees of freedom. The signal of sensor 24 is transmitted to a suitable device via lead assembly 26 in a known manner.

[0038] The first portion 18 has a first stiffness including a first transverse stiffness and a first axial stiffness. Here, the transverse stiffness refers to the stiffness in the radial direction of the body 12, and the axial stiffness refers to the stiffness in the axial direction of the body 12. The second portion 20 has a second stiffness including a second transverse stiffness and a second axial stiffness.

[0039] The first axial stiffness of the first portion 18 is less than the first axial stiffness of the second portion 20. Specifically, the first axial stiffness of the first portion 18 is in the range of 1.4 mN / mm to 30 mN / mm. Specifically, the J-shaped tip 22 of the first portion 18 has an axial stiffness in the range of 1.4 mN / mm to 30 mN / mm, and the rest of the first portion 18 has a first axial stiffness in the range of 1.4 mN / mm to 30 mN / mm. The second axial stiffness of the second portion is in the range of 1.4 mN / mm to 30 mN / mm.

[0040] The range of the first lateral stiffness of the first portion 18 is also different from the range of the second lateral stiffness of the second portion 20. The range of the first lateral stiffness of the first portion 18 is 39 mN / mm to 2.28 N / mm, and the range of the second lateral stiffness of the second portion 20 is 1.75 N / mm to 2.28 N / mm.

[0041] Further, the first transverse stiffness of the first portion 18 is homogenous along the axial extension of the first portion 18. The J-shaped tip 22 has a transverse stiffness of 39 mN / mm to 353 mN / mm. The rest of the first portion 18 has a first transverse stiffness of 255 mN / mm to 2.28 N / mm, but a gradient can be formed from the end of the J-shaped tip 22 to the end of the first portion 18 in a manner that gradually increases the first transverse stiffness.

[0042] This ensures that the guidewire 10 can be advanced through the blood vessel without forming a wave and without the risk of puncturing the blood vessel. Further, the stiffness of the first portion 18 is reduced compared to the stiffness of the second portion 20, ensuring that the guidewire can pass through the aortic valve without puncturing the aortic valve.

[0043] In this embodiment, the varying stiffness may be achieved by varying the material composition of the outer sheath 38 in the axial direction between the distal axial end 14 and the proximal axial end 16. Further, a support structure may be provided to vary the stiffness between the first portion 18 and the second portion 20. The support structure may be embedded in the outer sheath 38 or may be positioned radially inward of the outer sheath 38.

[0044] Further, the varying stiffness may also be achieved by using a stabilizing coil 30 disposed in the hollow portion 28 of the body 12 of the guidewire 10, as depicted in FIG. Figure 2 Of course, the stabilizing coil 30 can also be placed outside the hollow portion 28.

[0045] In the second embodiment, the stabilizing coil 30 is disposed in the second portion 20 and extends from the end of the first portion 18 to the proximal axial end 16. The stabilizing coil 30 increases the stiffness of the second portion 20, i.e., the second axial stiffness and the second lateral stiffness. Therefore, the material composition of the outer sheath 38 can be selected to be homogeneous, resulting in a first lateral stiffness and a first axial stiffness that are different from the second lateral stiffness and the second axial stiffness due to the stabilizing coil 30. The first lateral stiffness and the first axial stiffness of the first portion 18 can be in the range as indicated above according to the first embodiment. Therefore, the second lateral stiffness and the second axial stiffness can also be in the range as indicated above according to the first embodiment.

[0046] Figure 2 The second embodiment of the guide wire 10 shown is similar to Figure 1 The guidewire 10 of the first embodiment shown is different in that the lead assembly 26 is wound parallel to the coil of the stabilizing coil 30. Figure 2 As shown, the lead wire assembly 26 can be guided radially inside the coils of the stabilizing coil 30. Of course, it is also possible to guide the lead wire assembly 26 between the coils of the stabilizing coil 30. However, the lead wire assembly 26 is coated with a protective coating to prevent tearing of the lead wire assembly 26 caused by, for example, bending of the guide wire 10 during its placement.

[0047] exist Figure 3 A schematic side cross-sectional view of a third embodiment of a guidewire 10 is shown in FIG. This guidewire 10 according to the third embodiment differs from the guidewire according to the first embodiment in that the sensor 24 is arranged in a housing 32. The housing 32 comprises a magnetically permeable material, for example a plastic material like PTFE or polysiloxane. This ensures that electromagnetic tracking of the sensor 24 is possible.

[0048] The housing 32 may be disposed within the hollow portion 28 and thus radially inward of the outer sheath 38 in the first portion 18. Alternatively, the housing 32 may be configured as an intermediate portion located in the axial direction between the first portion 18 and the second portion 20. The first portion 18 and the second portion 20 may be molded into the housing 32. Further, the housing 32 may be provided as an extruded protection layer.

[0049] In addition, the first portion 18 includes a cardiac echo marker 36. The cardiac echo marker 36 includes a material that is not transparent to ultrasound (e.g., a ceramic material). In addition, the cardiac echo marker 36 can have a specific shape that allows a physician to identify the cardiac echo marker 36 when using medical ultrasound or ultrasound examination. Therefore, the echo marker 36 delivers further information about the position of the first portion 18 within the patient's body. Of course, the guidewire 10 can include more than one echo marker 36 distributed along the axial extension of the body 12 of the guidewire 10.

[0050] exist Figure 4 A schematic side cross-sectional view of a guidewire 10 for placing a medical device in the body of the patient according to a fourth embodiment is shown in FIG. The guidewire 10 according to the fourth embodiment differs from the guidewire 10 according to the first embodiment in that the sensor 24 is not arranged in the hollow portion 28. Instead, the sensor 24 is positioned radially outside the outer sheath 38 on the outer peripheral surface of the first portion 18. The sensor 24 is protected by a housing 34 in the form of a protective layer or coating.

[0051] Of course, the various features of the embodiments described above can be combined. For example, the echo marker 36 can also be arranged in the guidewire 10 according to the first embodiment, the second embodiment, or the fourth embodiment. Therefore, the stabilizing coil 30 can also be used together with the guidewire 10 according to, for example, the third embodiment or the fourth embodiment.

[0052] Exemplary embodiments

[0053] As already described, the technology described herein can be implemented in various ways. In this regard, the foregoing disclosure is intended to include (but not be limited to) the systems, methods, combinations, and sub-combinations described in the following exemplary embodiments. Preferred embodiments are described in the following paragraphs:

[0054] A1 A guidewire for placing a medical device into a patient's body, the guidewire comprising:

[0055] An elongated body having a distal axial end and a proximal axial end; wherein the elongated body comprises a first portion having a first stiffness and a second portion having a second stiffness, wherein:

[0056] The first stiffness of the first portion is different from the second stiffness of the second portion.

[0057] A2 A guidewire according to paragraph A1, wherein the first portion extends from the distal axial end in the direction of the proximal axial end.

[0058] A3 A guidewire according to paragraph A1 or A2, wherein the second portion is adjacent to the first portion and extends in the direction of the proximal axial end.

[0059] A4 A guidewire according to any one of the preceding paragraphs A1 to A3, wherein the first stiffness comprises a first axial stiffness, and the second stiffness comprises a second axial stiffness, wherein the first axial stiffness is different from the second axial stiffness.

[0060] A5 A guidewire according to paragraph A4, wherein the first axial stiffness is less than the second axial stiffness.

[0061] A6 The guidewire according to paragraph A4 or A5, wherein the first axial stiffness is 1.4

[0062] mN / mm to 30 mN / mm, and / or wherein the second axial stiffness is in the range of 1.4 mN / mm to 30 mN / mm.

[0063] A7 A guidewire according to any one of the preceding paragraphs A1 to A6, wherein the first stiffness comprises a first transverse stiffness, and the second stiffness comprises a second transverse stiffness, wherein the range of the first transverse stiffness is different from the range of the second transverse stiffness.

[0064] A8 The guidewire according to paragraph A7, wherein the first transverse stiffness is in the range of 20

[0065] mN / mm to 3.00 N / mm, preferably 30 mN / mm to 2.30 N / mm, and more preferably 39 mN / mm to 2.28 N / mm.

[0066] A9 A guidewire according to paragraph A7 or A8, wherein the second lateral stiffness ranges from 1.00 N / mm to 3.50 N / mm, preferably 1.50 N / mm to 3.00 N / mm, and more preferably 1.75 N / mm to 2.28 N / mm.

[0067] A10 A guidewire according to any one of the preceding paragraphs A1 to A9, wherein the first

[0068] Some have an axial extension of up to 15 cm.

[0069] A11 A guidewire according to any one of the preceding paragraphs A1 to A10, wherein the elongated

[0070] The body has an axial extension of 120 cm to 260 cm.

[0071] A12 A guidewire according to any one of the preceding paragraphs A1 to A11, wherein the first

[0072] The portion includes an atraumatic tip extending from the distal axial end.

[0073] A13 The guidewire of paragraph A12, wherein the atraumatic tip is a J-shaped tip. A14 The guidewire of paragraph A12 or A13, wherein the atraumatic tip has an axial stiffness in the range of 1.4 mN / mm to 30 mN / mm.

[0074] A15 A guidewire according to paragraph A13 or A14, wherein the atraumatic tip has 39

[0075] mN / mm to 353mN / mm lateral stiffness.

[0076] A16 A guidewire according to any one of the preceding paragraphs A1 to A15, wherein the guidewire

[0077] Further comprising a sensor.

[0078] A17 A guidewire according to paragraph A16, wherein the sensor is disposed in or close to the first portion.

[0079] A18 A guidewire according to paragraph A16 or A17, wherein the sensor is disposed in the area between the atraumatic tip and the second portion.

[0080] A19 A guidewire according to any one of paragraphs A16 to A18, wherein the guidewire

[0081] The sensor is disposed in a magnetically permeable housing.

[0082] A20 A guidewire according to paragraph A19, wherein the shell comprises a plastic material.

[0083] A21 A guidewire according to any one of paragraphs A16 to A20, wherein the guidewire

[0084] The sensor is arranged in the extruded protective layer.

[0085] A22 A guidewire according to any one of paragraphs A16 to A21, wherein the guidewire

[0086] The wire further comprises a lead assembly, wherein the lead assembly (26) is attached to the sensor.

[0087] A23 A guidewire according to paragraph A22, wherein the guidewire assembly extends in the axial direction.

[0088] to the proximal axial end of the body.

[0089] A24 A guidewire according to paragraph A22 or A23, wherein the lead assembly is preferably

[0090] To coat or be covered.

[0091] A25 A guidewire according to any one of paragraphs A1 to A24, wherein the body

[0092] Including hollow parts.

[0093] A26 A guidewire according to paragraph A25, wherein the lead assembly is disposed within the hollow portion.

[0094] A27 A guidewire according to any of the preceding paragraphs A1 to A26, wherein the body comprises a stabilizing coil.

[0095] A28 A guidewire according to paragraph A27, wherein the lead assembly is wound parallel to the stabilization coil.

[0096] A29 A guidewire according to any of the preceding paragraphs A16 to A28, wherein the guidewire comprises at least one additional sensor.

[0097] A30 The guidewire of paragraph A29, wherein the guidewire comprises a plurality of additional sensors. A31 The guidewire of paragraph A29 or A30, wherein the at least one additional sensor

[0098] The sensor is disposed at a specific distance from the distal end to the proximal end.

[0099] A32 A guidewire according to paragraph A29 or A30, wherein the at least one additional sensor

[0100] The guidewire assembly (26) is provided at a specific distance from the sensor in the area between the atraumatic tip and the second portion or in the atraumatic tip. A33 The guidewire according to paragraph A31 or A32, wherein the specific distance is 10 cm. A34 The guidewire according to any of paragraphs A29 to A33, wherein the lead assembly (26) is attached to the at least one additional sensor.

[0101] A35 A guidewire according to any one of paragraphs A29 to A34, wherein

[0102] At least one further sensor is arranged in a magnetically permeable housing, which preferably comprises a plastic material.

[0103] A36 A guidewire according to any one of paragraphs A29 to A35, wherein

[0104] At least one further sensor is arranged in the extruded protective layer.

[0105] A37 A guidewire according to any one of paragraphs A16 to A36, wherein the guidewire

[0106] The sensor comprises a measuring coil, wherein the measuring coil is wound directly on a portion of the guide wire, preferably on a portion of the body, preferably on the hollow portion of the body.

[0107] A38 A guidewire according to paragraph A37, wherein the at least one additional sensor comprises a measuring coil, wherein the measuring coil is directly wound around a portion of the guidewire, preferably

[0108] Optionally on a portion of the body, preferably on the hollow portion of the body. A39 A guidewire according to any of the preceding paragraphs A1 to A28, wherein the body comprises at least one cardiac echo marker.

[0109] As used herein, the terms "approximately," "about," "substantially," and similar terms are intended to have a broad meaning consistent with the common and acceptable usage of those skilled in the art associated with the subject matter of the present disclosure. It should be understood by those skilled in the art who review the present disclosure that these terms are intended to allow the description of certain features to be described in a manner that does not limit the scope of these features to the precise numerical ranges provided. Therefore, these terms should be interpreted as indicating insubstantial or insignificant modifications or substitutions of the subject matter described, and are considered to be within the scope of the present disclosure. As used herein, the terms "at least partially" or "partially" are intended to mean both partially and completely or comprehensively, respectively.

[0110] In this article, "proximal" and "distal" are relative to medical personnel or doctors. Therefore, when a guide wire is introduced into a patient's body, proximal means something relatively close to the doctor, while distal means something relatively far away from the doctor.

[0111] Reference numerals

[0112] 10 Guidewire

[0113] 12 Main Body

[0114] 14 distal axial end

[0115] 16 Proximal axial end

[0116] 18 Part 1

[0117] 20 Part 2

[0118] 22 Atraumatic Tip / J-Tip

[0119] 24 sensors

[0120] 26 Lead Assembly

[0121] 28 Hollow part

[0122] 30 Stabilizing coil

[0123] 32 Shell

[0124] 34 Shell / Coating

[0125] 36 Echocardiogram Markers

[0126] 38 outer sheath.

Claims

1. A guide wire (10) for placing a medical device into a patient's body, the guide wire (10) include: an elongated body (12) having a distal axial end (14) and a proximal axial end (16), wherein the elongated body (12) comprises a first portion (18) having a first stiffness and a second portion (20) having a second stiffness, wherein the first stiffness of the first portion (18) is different from the second stiffness of the second portion (20).

2. The guide wire (10) according to claim 1, in, The first portion (18) extends from the distal axial end (14) in a direction toward the proximal axial end (16), and The second portion (20) is adjacent to the first portion (18) and extends toward the proximal axial end (16).

3. The guide wire (10) according to claim 1 or 2, in, The first stiffness comprises a first axial stiffness and the second stiffness comprises a second axial stiffness, wherein the first axial stiffness is different from the second axial stiffness, wherein the first axial stiffness is preferably smaller than the second axial stiffness.

4. The guide wire (10) according to claim 3, in, The first axial stiffness is in the range of 1.4 mN / mm to 30 mN / mm, and / or wherein the second axial stiffness is in the range of 1.4 mN / mm to 30 mN / mm.

5. The guide wire (10) according to any one of the preceding claims, in, The first stiffness includes a first lateral stiffness and the second stiffness includes a second lateral stiffness, wherein a range of the first lateral stiffness is different from a range of the second lateral stiffness.

6. The guide wire (10) according to claim 5, wherein: in, The first lateral stiffness is in the range of 39 mN / mm to 2.28 N / mm, and / or wherein the second lateral stiffness is in the range of 1.75 N / mm to 2.28 N / mm.

7. The guide wire (10) according to any one of the preceding claims, in, The first portion (18) comprises an atraumatic tip (22) extending from the distal axial end (14), wherein the atraumatic tip (22) is preferably a J-shaped tip.

8. The guide wire (10) according to claim 7, in, The atraumatic tip (22) has an axial stiffness in the range of 1.4 mN / mm to 30 mN / mm and / or a lateral stiffness in the range of 39 mN / mm to 353 mN / mm.

9. The guide wire (10) according to any one of the preceding claims, in, The guidewire (10) further comprises a sensor (24), wherein the sensor (24) is arranged in the first part (18) or in close proximity to the first part, wherein the sensor (24) is preferably arranged in a region between the atraumatic tip (22) and the second part (20).

10. The guide wire (10) according to claim 9, in, The guidewire (10) further comprises a lead assembly (26), wherein the lead assembly (26) is attached to the sensor (24), wherein the lead assembly (26) extends in an axial direction to the proximal axial end (26) of the body (12), and wherein the lead assembly (26) is preferably coated or covered.

11. The guide wire according to claim 10, in, The body (12) includes a hollow portion (28), wherein the lead assembly (26) is preferably disposed within the hollow portion (28).

12. The guide wire (10) according to any one of the preceding claims, in, The body (12) includes a stabilizing coil (30), and wherein the lead assembly (26) is preferably wound in parallel with the stabilizing coil (30).

13. The guide wire (10) according to any one of the preceding claims 9 to 12, in, The sensor (24) is disposed in a magnetically permeable housing (32, 34), the housing (32, 34) preferably comprising a plastic material.

14. The guide wire (10) according to any one of the preceding claims 9 to 13, in, The sensor (24) is disposed within the extruded protective layer (32).

15. The guidewire according to any one of the preceding claims 9 to 14, in, The guidewire comprises at least one further sensor, preferably a plurality of further sensors.

16. The guide wire (10) according to claim 15, in, The at least one additional sensor is arranged at a specific distance from the distal end (14) to the proximal end (16), or is arranged at a specific distance from the sensor (24) arranged in the area between the anti-injury tip (22) and the second part (20), or is arranged in the anti-injury tip (22), wherein the specific distance is preferably 10 cm.

17. The guide wire (10) according to claim 15 or 16, in, The lead assembly (26) is attached to the at least one additional sensor.

18. The guide wire (10) according to any one of the preceding claims 15 to 17, in, The at least one further sensor is arranged in a magnetically permeable housing (32, 34), the housing (32, 34) preferably comprising a plastic material.

19. The guide wire (10) according to any one of the preceding claims 15 to 18, in, The at least one further sensor is arranged within the extruded protective layer (32).

20. The guide wire (10) according to any one of the preceding claims 9 to 12 or 15 to 17, in, The sensor comprises a measuring coil, wherein the measuring coil is wound directly on a portion of the guide wire (10), preferably on a portion of the body (12), preferably on the hollow portion (28) of the body (12).

21. The guide wire (10) according to claim 20, in, The at least one further sensor comprises a measuring coil, wherein the measuring coil is wound directly on a portion of the guide wire (10), preferably on a portion of the body (12), preferably on the hollow portion (28) of the body (12).

22. The guide wire (10) according to any one of the preceding claims, in, The body (12) further includes at least one echocardiographic marker (36).

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