Guide wire

Abstract

The present invention relates to a guide wire (10) for placing a medical device in a patient's body, the guide wire (10) comprising an elongated body (12) having a distal shaft end (14) and a proximal shaft end (16). The elongated body (12) comprises a first portion (18) having a first stiffness and a second portion (20) having a second stiffness. The first stiffness of the first portion (18) is different from the second stiffness of the second portion (20).

Description

Technical Field

[0001] The present invention relates to a guide wire for placing a medical device in a patient's body.

Background Art

[0002] Medical devices, such as intravascular blood pumps, intracardiac blood pumps or catheters, can be introduced into a patient in various ways. Such medical devices are generally introduced surgically or percutaneously during cardiac surgery through the vasculature. In one common technique, the medical device is inserted using a guide wire through the femoral artery or axillary artery. By inserting the guide wire into the corresponding artery by arteriotomy, an insertion path for the medical device can be created. Then, the guide wire is advanced through the corresponding artery until the distal shaft end of the guide wire is individually deployed into the left or right ventricle. And a part of the medical device is advanced along the guide wire until it is correctly positioned within the corresponding ventricle. After the insertion of the medical device is completed, the guide wire is withdrawn from the patient's body.

[0003] Furthermore, when it is necessary to replace a placed medical device, the guide wire is re-advanced along the medical device to be replaced until the distal shaft end is correctly positioned within the patient's heart. After that, the medical device is withdrawn from the patient's body and the guide wire is left stationary. And then, a new medical device is advanced along the guide wire as described above.

[0004] When the medical device is a blood pump, various types are known from the prior art, and the aim is placed on supporting the function of the patient's heart in short-term applications where the blood pump is left in the patient for several days or weeks, or in long-term applications where the blood pump is left in the patient's heart for several weeks or months.

[0005] Generally, the aim of a blood pump is to provide hemodynamic support by extracting blood from a patient's heart into the blood vessels. When placed in the left ventricle of a patient's heart, the blood pump pumps blood, for example, from the left ventricle of the heart and into, for example, the aorta. When placed in the right ventricle of a patient's heart, the blood pump pumps blood from the inferior vena cava, bypasses the right atrium and right ventricle, and pumps it into the pulmonary artery.

[0006] During a planned surgery, by introducing a guidewire into the patient's body using fluoroscopy, the correct positioning of the guidewire and thus the medical device within the patient's heart can be reliably achieved. Typically, X-rays are used in fluoroscopy.

[0007] However, there are several limitations and side effects associated with fluoroscopy, especially with regard to X-rays. During a planned surgery for the individual placement of a medical device or guidewire, X-rays cannot be used without restriction. In addition, patients and physicians are exposed to a large amount of radiation during X-ray irradiation. Even when it becomes necessary to immediately introduce a medical device into the patient's body due to an emergency situation, for example, in an intensive care unit or an ambulance, X-rays are often not available.

[0008] Furthermore, some skill and intervention skills by the physician are required to correctly position the distal shaft end of the guidewire within the patient's heart. In particular, it is necessary to prevent the guidewire from piercing the blood vessel or entering an unexpected blood vessel, such as the coronary artery, during placement.

Summary of the Invention

Problems to be Solved by the Invention

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

Means for Solving the Problems

[0010] According to a first aspect, a guide wire for placing a medical device in a patient's body includes an elongated body having a distal shaft end and a proximal shaft end. The elongated body includes a first portion having a first rigidity and a second portion having a second rigidity. The first rigidity of the first portion is different from the second rigidity of the second portion.

[0011] Therefore, by selecting the first rigidity of the first portion, it can be ensured that it is flexible enough to reliably prevent perforation of blood vessels. Furthermore, by selecting the first rigidity of the first portion, it can be made suitable for passing, for example, through an arterial valve when introducing the guide wire into the patient's body. By selecting the second rigidity of the second portion, it may be made hard enough to feed the medical device and advance the guide wire in the patient's body.

[0012] Preferably, the first portion extends in the direction from the distal shaft end to the proximal shaft end. The second portion can be adjacent to the first portion and extend in the direction of the proximal shaft end. The second portion may be immediately adjacent to the first portion or may be in proximity. Thus, the term "adjacent" does not necessarily mean that there is direct contact between the first portion and the second portion, and there may be an intermediate portion between the first portion and the second portion. Accordingly, the first portion can be the tip portion of the guide wire, and the second portion can include the rest of the guide wire. Of course, a third portion having a rigidity different from that of the first portion and / or the second portion may be provided adjacent to the second portion and extend in the direction of the proximal shaft end.

[0013] Preferably, the first rigidity includes a first axial rigidity and the second rigidity includes a second axial rigidity, and the first axial rigidity is made different from the second axial rigidity. Thereby, it is possible to reliably select a suitable rigidity for the first portion and prevent perforation of blood vessels. On the other hand, a sufficient rigidity can be selected for the second portion to enable transmission of the force to push the guide wire forward.

[0014] Preferably, the first-axis rigidity is made lower than the second-axis rigidity. Therefore, the first-axis rigidity may be in the range of 1.4 mN / mm to 30 mN / mm. The second-axis rigidity may be in the range of 1.4 mN / mm to 30 mN / mm. By making the second-axis rigidity sufficiently high, it becomes possible to push the guide wire forward without the risk of waveform formation. By making the first-axis rigidity sufficiently low, it is possible to prevent perforation of the blood vessel while pushing the guide wire forward. Alternatively, the first-axis rigidity may be made substantially the same as the second-axis rigidity.

[0015] Preferably, the first rigidity is the one including the first lateral rigidity, the second rigidity is the one excluding the second lateral rigidity, and the range of the first lateral rigidity is made different from the range of the second lateral rigidity. Preferably, the range of the first lateral rigidity is 20 mN / mm to 3.00 N / mm, preferably 30 mN / mm to 2.30 N / mm, and particularly preferably 39 mN / mm to 2.28 N / mm. Preferably, the range of the second lateral rigidity is 1.00 N / mm to 3.50 N / mm, preferably 1.50 N / mm to 3.00 N / mm, and particularly preferably 1.75 N / mm to 2.28 N / mm. Thereby, not only is a sufficiently high degree of bendability ensured, but also the risk of blood vessel perforation when pushing the guide wire forward is further reduced.

[0016] The first part preferably has an axial extension reaching 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 part is provided with a non-traumatic tip extending from the distal axial end. The non-traumatic tip is preferably a J tip. By suitably selecting the radius of the J tip to be sufficiently large, it is possible to prevent the guide wire from entering an unexpected blood vessel, such as the coronary artery, when the guide wire is being pushed forward. For this purpose, it is desirable that the non-traumatic tip has an axial rigidity in the range of 1.4 mN / mm to 30 mN / mm and a lateral rigidity in the range of 39 mN / mm to 353 mN / mm.

[0018] In addition, when the first axial rigidity and / or the first lateral rigidity is set and / or a non-traumatic tip is provided within the scope of the present disclosure, it is not necessary to pass the aortic valve through the pigtail at the distal axial end of the guide wire.

[0019] The guide wire may be provided with a sensor, and the sensor may be disposed inside or adjacent to the first portion. Preferably, the sensor can be disposed within the region between the non-traumatic tip and the second portion. Alternatively, the sensor may be integrated within the non-traumatic tip. Preferably, the sensor is a tracking sensor. Preferably, the sensor is an electromagnetic tracking sensor. In this way, the position of the sensor, and thus also that of the first portion of the guide wire, can be tracked inside the patient's body using a corresponding tracking device, for example an electromagnetic field generator. Thereby, further assistance can be provided to the physician when placing the guide wire inside the patient's body. Preferably, the guide wire is further provided with a lead arrangement. The lead arrangement may be attached to the sensor, or the lead arrangement may be extended along the axial direction to the proximal axial end of the body. The signal of the sensor can be individually communicated or transmitted by the lead arrangement.

[0020] Preferably, the body is provided with a hollow portion, and the lead arrangement may be disposed within the hollow portion. The lead arrangement is held within the hollow portion of the body and is not torn due to bending or snagging.

[0021] Preferably, the body is provided with a stabilizing coil, and the lead arrangement may be wound parallel to the stabilizing coil. This also suppresses tearing of the lead arrangement.

[0022] Preferably, the sensor is disposed within a magnetically permeable housing, and the housing is preferably made of a plastic material. The housing protects the sensor from damage and further provides signal continuity.

[0023] Alternatively, the sensor may be disposed within a protective layer, preferably within a protruding protective layer or coating. The protective layer is preferably made of a magnetically permeable material. The protective layer protects the sensor from damage and further provides continuity. Further, the entire body of the guide wire may be coated with the protective layer.

[0024] The guide wire may be provided with at least one additional sensor. The at least one additional sensor may be disposed at a specific distance from the distal end towards the proximal end, or at a specific distance from a sensor disposed within the atraumatic tip - inter - part region or within the atraumatic tip. Preferably, the specific distance may be 10 cm. The guide wire may be provided with a plurality of sensors scattered along the guide wire itself. These sensors may be arranged at equal intervals along the axial direction, for example, at the aforementioned specific distance. These sensors may also be arranged at unequal intervals along the axial direction.

[0025] Preferably, the sensor is provided with a measurement coil, and the measurement coil is wound directly on a part of the guide wire, preferably on a part of the body, preferably on the hollow part of the body. Preferably, the aforementioned at least one additional sensor is provided with a measurement coil, and the measurement coil is wound directly on a part of the guide wire, preferably on a part of the body, preferably on the hollow part of the body. This can also be done at several locations on the guide wire. Further, by covering the whole thereon, splitting of the lead arrangement can be prevented. Preferably, the body is provided with at least one cardiac echo marker. This enables tracking of the position of the guide wire by medical ultrasound, i.e., sonography.

[0026] The medical device according to the present disclosure can be associated with the aforementioned intravascular blood pump, intracardiac blood pump, or catheter.

[0027] The foregoing summary and the following detailed description of the preferred embodiments will be better understood when read in conjunction with the accompanying drawings. Refer to those drawings for the purpose of depicting the present disclosure. However, the technical scope of the present disclosure is not limited to the specific embodiments disclosed in the drawings.

[0028] The drawings are as follows.

Brief Description of the Drawings

[0029]

Figure 1

Figure 2

Figure 3

Figure 4

Modes for Carrying Out the Invention

[0030] A guide wire 10 for placing a medical device in a patient's body, and a schematic longitudinal cross-sectional appearance of that according to the first embodiment is shown in FIG. 1. The guide wire 10 includes an elongated body 12 having a distal shaft end 14 and a proximal shaft end 16. The body 12 has a substantially cylindrical shape and has a total length of 120 cm to 260 cm, that is, the total axial extension between the distal shaft end 14 and the proximal shaft end 16 is 120 cm to 260 cm.

[0031] The body 12 has a first portion 18 extending from the distal shaft end 14 towards the proximal shaft end 16, and a second portion 20 extending from the end of the first portion 18 to the proximal shaft end 16. The first portion 18 has a total length of 15 cm and is provided with a non-invasive tip 22 in the form of a J-chip. The J-chip 22 has a length of about 8 cm and ends at the dashed line shown on the left side in Figure 1. The J-chip 22 can be made of a plastic material or a metal coil. The boundary between the first portion 18 and the second portion 20 is indicated by the dashed line on the right side in Figure 1. The J-chip 22 is configured such that when it is individually pushed forward into the patient's body or heart, the guide wire 10 does not enter small vascular structures such as coronary arteries. Therefore, it is necessary to make the diameter of the J-chip 22 large enough so that it does not enter the coronary arteries.

[0032] The guide wire 10 can have an outer diameter of 0.025 inches (about 0.0635 cm) or less and has an outer sheath 38 made of a highly biocompatible plastic material such as PTFE or some other hydrophilic material. The outer sheath 38 defines a hollow portion 28 within the body 12 of the guide wire 10.

[0033] The sensor 24 is disposed within the hollow portion 28 of the body 12. Specifically, the sensor 24 is disposed within the first portion 18 and is within the region between the end of the J-chip 22 and the end of the first portion 18, that is, within the region from 8 cm to 15 cm from the distal shaft end 14.

[0034] The lead array 26 is attached to the sensor 24 and extends within the hollow portion 28 to reach the proximal shaft end 16. For the sake of simplicity, the lead array 26 is shown as a line, but it may be provided with two or more twisted or non-twisted leads. In addition, the lead array 26 may be covered or coated, for example, with a PTFE coating. The sensor 24 can be an electromagnetic tracking sensor, and the position of the sensor 24 can be tracked by a corresponding device such as an electromagnetic field generator. The sensor 24 can also be a sensor that supports position measurement in six degrees of freedom or five degrees of freedom. The signal of the sensor 24 is transmitted to a corresponding device in a known manner via the lead array 26.

[0035] The first part 18 has a first rigidity composed of a first lateral rigidity and a first axial rigidity. Here, the lateral rigidity refers to the rigidity along the radial direction of the main body 12, and the axial rigidity refers to the rigidity along the axial direction of the main body 12. The second part 20 has a second rigidity composed of a second lateral rigidity and a second axial rigidity.

[0036] The first axial rigidity of the first part 18 is lower than the first axial rigidity of the second part 20. In particular, the first axial rigidity of the first part 18 is in the range of 1.4 mN / mm to 30 mN / mm. Among them, the J-chip 22 of the first part 18 has an axial rigidity in the range of 1.4 mN / mm to 30 mN / mm, and the rest of the first part 18 has a first axial rigidity in the range of 1.4 mN / mm to 30 mN / mm. The second axial rigidity of the second part is in the range of 1.4 mN / mm to 30 mN / mm.

[0037] The range of the first lateral rigidity of the first part 18 is also different from the range of the second lateral rigidity of the second part 20. The range of the first lateral rigidity of the first part 18 is 39 mN / mm to 2.28 N / mm, and the range of the second lateral rigidity of the second part 20 is 1.75 N / mm to 2.28 N / mm.

[0038] Furthermore, the first lateral rigidity of the first part 18 is not uniform along the axial extension of the first part 18. The J-chip 22 has a lateral rigidity of 39 mN / mm to 353 mN / mm. The remaining part of the first part 18 has a first lateral rigidity of 255 mN / mm to 2.28 N / mm, and a gradient can be formed in which the first lateral rigidity gradually increases from the end of the J-chip 22 to the end of the first part 18.

[0039] This ensures that the guide wire 10 can be advanced through the blood vessel without forming waves and without the risk of perforating the blood vessel. Furthermore, since the rigidity of the first part 18 is reduced compared to the rigidity of the second part 20, it is ensured that the aortic valve can be passed to the guide wire without perforation.

[0040] In this embodiment, variable rigidity can be achieved by changing the material composition of the outer sheath 38 along the axial direction between the distal shaft end 14 and the proximal shaft end 16. Further, a support structure may be provided to change the rigidity between the first part and the second part. The support structure may be embedded in the outer sheath 38, or may be disposed radially inside the outer sheath 38.

[0041] Furthermore, as shown in the second embodiment of the present disclosure, which is depicted as a schematic longitudinal cross-sectional view in FIG. 2, variable rigidity can also be achieved by using the stabilization coil 30 disposed in the hollow portion 28 of the main body 12 of the guide wire 10. Of course, the stabilization coil 30 can also be disposed outside the hollow portion 28.

[0042] In the second embodiment, the stabilization coil 30 is disposed in the second part 20 and extends from the end of the first part 18 to the proximal shaft end 16. The stabilization coil 30 increases the rigidity of the second part 20, that is, the second axial rigidity and the second lateral rigidity. Therefore, the material composition of the outer sheath 38 can be selected to be homogeneous, and as a result, different first lateral rigidity and first axial rigidity are provided as compared with the second lateral rigidity and the second axial rigidity which are partly due to the stabilization coil 30. The first lateral rigidity and the first axial rigidity of the first part 18 can be within the range described above with respect to the first embodiment. Accordingly, the second lateral rigidity and the second axial rigidity can also be within the range described above with respect to the first embodiment.

[0043] The guide wire of the second embodiment shown in FIG. 2 is also different from the guide wire according to the first embodiment shown in FIG. 1 in that the lead arrangement 26 is wound parallel to the coils of the stabilization coil 30. As shown in FIG. 2, the lead arrangement 26 can be guided and made to exist radially inside the coils of the coil arrangement 26. Of course, it is also possible to guide the lead arrangement 26 and make it exist between the coils of the stabilization coil 30. Even in that case, by covering the lead arrangement 26 with a protective coating, for example, tearing of the lead arrangement due to bending of the guide wire 10 during the arrangement of the guide wire 10 can be prevented.

[0044] The schematic longitudinal sectional appearance of the third embodiment of the guide wire 10 is shown in FIG. 3. The guide wire 10 according to the third embodiment is different from the guide wire according to the first embodiment in that the sensor 24 is disposed within the housing 32. The housing 32 is made of a magnetically permeable material, such as a plastic material like silicone or PTFE. Thereby, the electromagnetic tracking of the sensor 24 is surely enabled.

[0045] The housing 32 may be disposed within the hollow portion 28 at the first portion 18, and thus radially inside the outer sheath 38. Alternatively, the housing 32 may be configured as an intermediate portion between the first portion 18 and the second portion 20 along the axial direction. The first portion 18 and the second portion 20 may be molded to the housing 32. Further, the housing 32 may be provided as a protruding protective layer.

[0046] In addition, the first portion 18 includes an echogenic marker 36. The echogenic marker 36 is made of a material that is not ultrasonically transmissive, such as a ceramic material. In addition, the echogenic marker 36 may have a special shape, whereby a doctor can identify the echogenic marker 36 when using medical ultrasound, i.e., sonography. Thus, the echogenic marker 36 provides further information regarding the position of the first portion 18 within the patient's body. Of course, the guide wire 10 may be provided with a plurality of echogenic markers 36 distributed along the axial extension of the body 12 of the guide wire 10.

[0047] A guide wire 10 for disposing a medical device within a patient's body, and the schematic longitudinal sectional appearance of that according to the fourth embodiment is shown in FIG. 4. The guide wire 10 according to the fourth embodiment is different from the guide wire according to the first embodiment in that the sensor 24 is not disposed within the hollow portion 28. Rather, the sensor 24 is disposed on the outer peripheral surface of the first portion 18, radially outside the outer sheath 38. The sensor 24 is protected by a housing 34 in the form of a protective layer or coating.

[0048] Regardless, the individual features of the above-described embodiments can also be combined. For example, the echo marker 36 may be provided on the guide wire 10 according to the first embodiment, the second embodiment, or the fourth embodiment. Following this, the stabilization coil 30 can also be used in combination with the guide wire according to, for example, the third embodiment or the fourth embodiment.

[0049] [Exemplary Implementations] As described above, the technology described in the present application can be realized in various ways. The aim of the foregoing disclosure in this regard is, but not limited to, systems, methods, and their combinations and sub-combinations, including those described in the exemplary implementations below. Preferred embodiments are described in the following paragraphs: A1 A guide wire for disposing a medical device within a patient's body, comprising an elongated body having a distal shaft end and a proximal shaft end, the elongated body comprising a first portion having a first rigidity and a second portion having a second rigidity, the first rigidity of the first portion being different from the second rigidity of the second portion. A2 The guide wire according to paragraph A1, wherein the first portion extends in a direction from the distal shaft end to the proximal shaft end. A3 The guide wire according to paragraph A1 or A2, wherein the second portion is adjacent to the first portion and extends in the direction of the proximal shaft end. A4 A guide wire according to any one of the preceding paragraphs A1 - A3, wherein the first rigidity comprises a first axial rigidity, the second rigidity comprises a second axial rigidity, and the first axial rigidity is different from the second axial rigidity. A5 The guide wire according to paragraph A4, wherein the first axial rigidity is lower than the second axial rigidity. A6 The guide wire according to paragraph A4 or A5, wherein the first axial rigidity is within the range of 1.4 mN / mm to 30 mN / mm, and / or the second axial rigidity is within the range of 1.4 mN / mm to 30 mN / mm. A guide wire according to any one of the preceding paragraphs A1 to A6, wherein the first stiffness comprises a first lateral stiffness, the second stiffness comprises a second lateral stiffness, and the range of the first lateral stiffness is different from the range of the second lateral stiffness. A guide wire according to paragraph A7, wherein the range of the first lateral stiffness is 20 mN / mm to 3.00 N / mm, preferably 30 mN / mm to 2.30 N / mm, and particularly preferably 39 mN / mm to 2.28 N / mm. A guide wire according to paragraph A7 or A8, wherein the range of the second lateral stiffness is 1.00 N / mm to 3.50 N / mm, preferably 1.50 N / mm to 3.00 N / mm, and particularly preferably 1.75 N / mm to 2.28 N / mm. A guide wire according to any one of the preceding paragraphs A1 to A9, wherein the first portion has an axial extension reaching 15 cm. A guide wire according to any one of the preceding paragraphs A1 to A10, wherein its elongated body has an axial extension of 120 cm to 260 cm. A guide wire according to any one of the preceding paragraphs A1 to A11, wherein the first portion comprises a non-traumatic tip extending from the distal axial end. A guide wire according to paragraph A12, wherein the non-traumatic tip is a J-tip. A guide wire according to paragraph A12 or A13, wherein the non-traumatic tip has an axial stiffness within the range of 1.4 mN / mm to 30 mN / mm. A guide wire according to paragraph A13 or A14, wherein the non-traumatic tip has a lateral stiffness of 39 mN / mm to 353 mN / mm. A guide wire according to any one of the preceding paragraphs A1 to A15, further comprising a sensor. A guide wire according to paragraph A16, wherein the sensor is disposed inside or next to the first portion. A guide wire according to paragraph A18, A16 or A17, wherein the sensor is disposed within a region between the atraumatic tip and the second portion. A guide wire according to any one of the preceding paragraphs A16 to A18, wherein the sensor is disposed within a magnetically permeable housing. A guide wire according to paragraph A19, wherein the housing contains a plastic material. A guide wire according to any one of the preceding paragraphs A16 to A20, wherein the sensor is disposed within a protruding protective layer. A guide wire according to any one of the preceding paragraphs A16 to A21, further comprising a lead arrangement, wherein the lead arrangement (26) is attached to the sensor. A guide wire according to paragraph A22, wherein the lead arrangement extends axially along the proximal shaft end of the body. A guide wire according to paragraph A22 or A23, wherein the lead arrangement is preferably coated or covered. A guide wire according to any one of the preceding paragraphs A1 to A24, wherein the body comprises a hollow portion. A guide wire according to paragraph A25, wherein the lead arrangement is disposed within the hollow portion. A guide wire according to any one of the preceding paragraphs A1 to A26, wherein the body comprises a stabilization coil. A guide wire according to paragraph A27, wherein the lead arrangement is wound parallel to the stabilization coil. A guide wire according to any one of the preceding paragraphs A16 to A28, wherein the guide wire comprises at least one additional sensor. A guide wire according to paragraph A29 of A30, wherein the guide wire comprises a plurality of further sensors. A guide wire according to paragraph A29 or A30 of A31, wherein at least one of the further sensors is disposed at a specific distance from the distal end towards the proximal end. A guide wire according to paragraph A29 or A30 of A32, wherein at least one of the further sensors is disposed at a specific distance from a sensor disposed within the non-traumatic tip / second part region or within the non-traumatic tip. A guide wire according to paragraph A31 or A32 of A33, wherein the specific distance is 10 cm. A guide wire according to any one of the preceding paragraphs A29 to A33, wherein the lead arrangement (26) is attached to at least one of the further sensors. A guide wire according to any one of the preceding paragraphs A29 to A34, wherein at least one of the further sensors is disposed within a magnetically permeable housing, and the housing preferably contains a plastic material. A guide wire according to any one of the preceding paragraphs A29 to A35, wherein at least one of the further sensors is disposed within a protruding protective layer. A guide wire according to any one of the preceding paragraphs A16 to A36, wherein the sensor comprises a measurement coil, and the measurement coil is wound directly on a part of the guide wire, preferably on a part of the body, preferably on a hollow part of the body. A guide wire according to paragraph A37 of A38, wherein at least one of the further sensors comprises a measurement coil, and the measurement coil is wound directly on a part of the guide wire, preferably on a part of the body, preferably on a hollow part of the body. A guide wire according to any one of paragraphs A1 to A28 preceding A39, the body of which is provided with at least one cardiac echo marker.

[0050] According to the usage in this application, the words "about", "substantially", "essentially" and the like are intended to have a broad meaning that is consistent with the common and acceptable usage to those skilled in the technical field related to the subject matter of this disclosure (so-called persons skilled in the art). It should be understood by those who are persons skilled in the art and have considered this disclosure that the purpose of these words is, when describing specific features, to enable those features to be described without limiting their technical scope to a precise numerical range. Therefore, these words should be construed as indicating that non-substantive or non-important modifications or alterations of the described subject matter are considered to be within the technical scope of this disclosure. The words "at least partially" or "partially" mean, according to the usage in this application, both partially and as a whole or completely individually.

[0051] In this application, "proximal" and "distal" are viewed from the perspective of medical staff or physicians. That is, when the guide wire is introduced into the patient's body, what is indicated as proximal is something relatively close to the physician, and what is indicated as distal is something relatively far from the physician.

Explanation of reference numerals

[0052] 10 Guide wire, 12 Body, 14 Distal shaft end, 16 Proximal shaft end, 18 First part, 20 Second part, 22 Non-traumatic tip / J-tip, 24 Sensor, 26 Lead array, 28 Hollow part, 30 Stabilizing coil, 32 Housing, 34 Housing / coating, 36 cardiac echo marker, 38 outer sheath.

Claims

1. A guide wire (10) for placing a medical device in a patient's body, The guide wire (10) comprises an elongated body (12) having a distal shaft end (14) and a proximal shaft end (16), The elongated body (12) comprises a first portion (18) having a first rigidity and a second portion (20) having a second rigidity, The guide wire in which the first rigidity of the first portion (18) is different from the second rigidity of the second portion (20).

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

3. The guide wire (10) according to claim 1 or 2, The first rigidity includes a first axial rigidity, the second rigidity includes a second axial rigidity, the first axial rigidity is different from the second axial rigidity, and the first axial rigidity is preferably lower than the second axial rigidity.

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

5. The guide wire (10) according to any one of claims 1 to 4, The first rigidity includes a first transverse rigidity, the second rigidity includes a second transverse rigidity, and the range of the first transverse rigidity is different from the range of the second transverse rigidity.

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

7. The guide wire (10) according to any one of claims 1 to 6, The first portion (18) comprises a non-traumatic tip (22) extending from the distal shaft end (14), and the non-traumatic tip (22) is preferably a J-tip.

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

9. The guide wire (10) according to any one of claims 1 to 8, A guide wire (10) further comprising a sensor (24), wherein the sensor (24) is disposed inside or beside the first portion (18), and the sensor (24) is preferably disposed in the region between the non-invasive tip (22) and the second portion (20).

10. The guide wire (10) according to claim 9, A guide wire (10) further comprising a lead arrangement (26), wherein the lead arrangement (26) is attached to the sensor (24), the lead arrangement (26) extends axially along the proximal end (26) of the body (12), and the lead arrangement (26) is preferably covered or coated.

11. The guide wire according to claim 10, The body (12) comprises a hollow portion (28), and the lead arrangement (26) is preferably disposed in the hollow portion (28).

12. The guide wire (10) according to any one of claims 1 to 11, The body (12) comprises a stabilization coil (30), and the lead arrangement (26) is preferably wound parallel to the stabilization coil (30).

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

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

15. The guide wire according to any one of claims 9 to 14, A guide wire comprising at least one additional sensor, preferably a plurality of additional sensors.

16. The guide wire (10) according to claim 15, The at least one additional sensor is disposed at a specific distance from the distal end (14) towards the proximal end (16), or at a specific distance from the sensor (24) disposed in the region between the non-invasive tip (22) and the second portion (20) or in the non-invasive tip (22), and the specific distance is preferably 10 cm.

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

18. A guide wire (10) according to any one of claims 15 to 17, wherein the at least one additional sensor is disposed within a magnetically permeable housing (32, 34), and the housing (32, 34) preferably contains a plastic material.

19. A guide wire (10) according to any one of claims 15 to 18, A guide wire in which the at least one additional sensor is disposed within a protruding protective layer (32).

20. A guide wire (10) according to any one of claims 9 to 12 and 15 to 17, wherein the sensor comprises a measurement coil, and the measurement coil is wound directly on a part of this guide wire, preferably on a part of the body, preferably on the hollow part of the body.

21. A guide wire (10) according to claim 20, wherein the at least one additional sensor comprises a measurement coil, and the measurement coil is wound directly on a part of this guide wire, preferably on a part of the body, preferably on the hollow part of the body.

22. A guide wire (10) according to any one of claims 1 to 21, A guide wire in which the body (12) further comprises at least one cardiac echo marker (36).

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