Flexible distal end guidewire with a rigid solid shaft

Abstract

A section (100) for use with a partial assembly (200) is disclosed. The section can include a solid core section (130) having a distal section (110, 131) with a first diameter and a proximal section (120, 132) with a second diameter, the second diameter can be greater than the first diameter. The section can include a coil (140) wound on the distal section of the solid core section. The proximal section can have a bending stiffness less than the bending stiffness of the distal section. The length of the distal section of the section can be less than the length of the portion. The length of the proximal section of the section can be greater than the length of the portion.

Description

Technical Field

[0001] The present invention relates to a medical device, and more particularly, to a flexible distal end having a rigid solid shaft Guide wire .

Background Art

[0002] Those inserted into the central vein catheter (central venous catheters ) etc. are usually formed of a material having a relatively low durometer hardness, and as a result, have insufficient column strength catheter . Column strength is usually advantageous when the distal tip catheter displaces during insertion, and particularly through the skin puncture site and the blood vessel puncture site catheter . Column strength is also advantageous when further advancing catheter through the puncture site. In such an example, column strength along catheter outside the vascular system is advantageous, but column strength along catheter inside the vascular system can be disadvantageous for guiding catheter along the blood vessel path. In some cases, catheter may incorporate an introducer needle to establish the column strength for inserting catheter . In such a case, it is necessary to withdraw the introducer needle before inserting guidewire . In many cases, this Guide wire has characteristics such as rigidity and flexibility for guiding catheter through the vascular system, but lacks the column strength to facilitate the advancement of catheter through the skin and blood vessel puncture sites. In some cases, catheter requires both guiding ability and column strength simultaneously. Therefore, while imparting column strength for advancing through the puncture site catheter to catheter , it is necessary to guide

[0003] through the blood vessel path. In this specification, to address the above Guide wire , catheter Assembly and method are disclosed. [Overview of the project]

[0004] In this specification, solid core wire (solid core wire The distal section has the distal portion of the solid core. wire Includes a proximal section having the proximal portion Guide wire ( (guide wire) The following is disclosed. The distal section is a solid core. wire It includes a coil wound around a solid core, and the proximal section is a solid core. wire It does not include the coil that is wound around it.

[0005] In some embodiments, Guide wire The proximal section is, Guide wire It has less bending stiffness than the distal section. In some embodiments, a solid core wire The diameter of the proximal part is that of a solid core wire It is larger than the diameter of its distal portion.

[0006] The distal section is directed towards the patient's vascular system. catheter ( catheter Insert ) and along the vascular system catheter It is configured to induce. The proximal section is catheter It is configured to be inserted through. The proximal section is also catheter It may be configured to provide column strength.

[0007] Guide wire During insertion, the proximal section catheter The column intensity is applied to the proximal portion, while the distal section follows the vascular system. catheter It may be configured to guide the distal portion.

[0008] solid core wire The proximal portion follows the proximal section. Guide wire can define the rigidity, and also along the proximal section Guide wire can define the outer diameter. In some embodiments, the proximal section is longer than the distal section. In some embodiments, Guide wire includes a non-invasive distal tip.

[0009] As used herein, catheter and Guide wire including catheter an assembly is disclosed. catheter is a flexible catheter tube, and catheter has a lumen extending along the length of, the length being catheter from the proximal end to the distal end of. The lumen also penetrates the flexible catheter tube. Guide wire is a distal section including the distal portion of the solid core wire and a proximal section including the proximal portion of the solid core wire . The diameter of the solid core wire along the proximal portion is larger than the diameter of the solid core wire along the distal portion.

[0010] <� In some embodiments, the length of the distal section is catheter shorter than the length of, and in some embodiments, the length of the proximal section is catheter longer than the length of. Guide wire The distal end of may be disposed within the lumen.

[0011] In use, Guide wire the distal section of may catheter extend distally beyond the distal end of, Guide wire the proximal section of may catheter [[ID=^7]]be disposed through the lumen of. In some embodiments, catheter the assembly includes catheter an introducer disposed through the lumen of catheter , the introducer catheter includes an introducer catheter lumen. The introducer needle is at least partially within the introducer catheter It may be positioned through the lumen. In some embodiments, the introduction needle is an introduction device. catheter It is positioned only through the distal portion of the lumen, Guide wire The introduction device catheter It is positioned through the proximal portion of the lumen.

[0012] This specification includes the following steps: Guide wire A method for using is disclosed. This method is Guide wire Includes the step of obtaining, Guide wire is a solid core wire The distal section, including the distal portion, and the solid core wire A proximal section including the proximal portion and a solid core along the proximal portion wire The diameter of the solid core along the distal portion wire It is larger than the diameter. This method, catheter Includes the step of obtaining, catheter From its distal end to its proximal end catheter This method includes a lumen that extends over a certain length. catheter With the device positioned outside the patient, catheter It passes through the lumen and enters the patient's vascular system. Guide wire This method includes a step through which the proximal section catheter So that it is positioned within the lumen from the distal end to the proximal end, Guide wire The process includes the step of positioning the object. Guide wire Also, the distal end of the proximal section catheter It is positioned to be located adjacent to the distal tip. This method involves passing through the vascular puncture site along with the distal end of the proximal section. catheter This method includes the step of inserting the distal tip. Guide wire Along the vascular system catheter This includes steps to advance the process.

[0013] In some embodiments, the advancing step is performed so that the distal end of the proximal section is positioned adjacent to the vascular puncture site within the lumen. Guide wire This includes the step of adjusting the position. The step of moving it forward further includes, catheter of Guide wireAlong with displacing it distally by a first distance within the vascular system, and repositioning the distal end of the proximal section adjacent to the vascular puncture site, Guide wire This may include retracting the object proximal through the lumen by a first distance. The advancement step may further include repeating the displacement step and the retraction step.

[0014] In some embodiments, the insertion step is performed at the proximal end. catheter While grasping it, Guide wire While grasping the proximal portion, apply compressive force in the distal direction. catheter and Guide wire This includes adding it to the mix.

[0015] In some embodiments, catheter teeth, catheter The method includes an introduction needle placed inside the lumen, and includes the step of withdrawing the introduction needle from the lumen before the insertion step. These and other features of the concepts provided herein will become more apparent to those skilled in the art in consideration of the accompanying drawings and the following description, which disclose in more detail specific embodiments of such concepts. [Brief explanation of the drawing]

[0016] [Figure 1A] This is a side view of a guide wire according to several embodiments. [Figure 1B] This is a detailed cross-sectional view of a portion of the guide wire shown in Figure 1A, according to several embodiments. [Figure 2] Figure 1A shows a catheter assembly including a guidewire according to several embodiments. [Figure 3A] Figure 2 shows a catheter assembly in a first state of insertion into a patient, according to several embodiments. [Figure 3B] Figure 2 shows a catheter assembly in a second state of insertion into a patient, according to several embodiments. [Figure 3C]This is a detailed cross-sectional view of a portion of the catheter assembly shown in Figure 3B, according to several embodiments. [Figure 3D] Figure 2 shows a catheter assembly in a third state of insertion into a patient, according to several embodiments. [Figure 3E] This is a detailed cross-sectional view of a portion of the catheter assembly in Figure 3D, according to several embodiments. [Modes for carrying out the invention]

[0017] Before disclosing some specific embodiments in more detail, it should be understood that certain embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that certain embodiments disclosed herein may have features that are easily separable from a particular embodiment and which, at their discretion, can be combined with or substituted for features of any of the other embodiments disclosed herein.

[0018] With regard to the terms used herein, it should be understood that these terms are intended to describe certain specific embodiments and do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., 1st, 2nd, 3rd, etc.) are generally used to distinguish or identify different features or steps within a group of features or steps and do not provide serial or numerical limitations. For example, features or steps labeled "1st," "2nd," and "3rd" do not necessarily have to appear in that order, and a particular embodiment containing such features or steps does not necessarily have to be limited to three features or steps. Indications such as "left," "right," "up," "down," "front," and "back" are for convenience and do not imply, for example, a specific fixed position, direction, orientation, etc. Instead, such indications are used to reflect, for example, a relative position, orientation, or direction. The singular forms "a," "an," and "the" include plural subjects unless explicitly indicated in the context.

[0019] Regarding "proximal," for example, as disclosed herein catheter The "proximal portion" or "proximal end portion" of is catheter It is intended to be near the clinician when it is used on the patient. catheter This includes a portion of it. Similarly, for example, catheter The "proximal length" is, catheter When used on a patient, it is intended to be near the clinician. catheter Includes the length. For example, catheter The "proximal end" of is catheter It is intended to be near the clinician when it is used on the patient. catheter Including the ends. catheter The proximal portion, proximal end portion, or proximal length of is catheter It can include the proximal end, catheter The proximal portion, proximal end portion, or proximal length of is catheter It is not necessary to include the proximal end of it. That is, unless the context suggests otherwise, catheter The proximal portion, proximal end portion, or proximal length of is catheter It is not the terminal portion or terminal length.

[0020] Regarding "distal," for example, as disclosed herein catheter The "distal portion" or "distal end portion" of is catheter It is intended to be near or within the patient when used on a patient. catheter This includes a portion of it. Similarly, for example, catheter The "distal length" is, catheter When used on a patient, it is intended to be near the patient or within the patient. catheter Includes the length. For example, catheter The "distal end" is, catheter It is intended to be near or within the patient when used on a patient. catheter Including the ends. catheter The distal portion, distal end portion, or distal length is catheter It can include the distal end, catheter The distal portion, distal end portion, or distal length is catheterIt is not necessary to include the distal end. That is, unless the context suggests otherwise, catheter The distal portion, distal end portion, or distal length is catheter It is not the terminal portion or terminal length.

[0021] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art. As mentioned above, through the puncture site catheter In order to move forward, catheter It is necessary to apply column intensity to the proximal portion, and at the same time, along the vascular pathway catheter The distal portion needs to be guided. This specification addresses the above. Guide wire , catheter Assembly and method are disclosed.

[0022] Figure 1A shows some embodiments described herein. Guide wire This is a side view of the 100. Guide wire 100 is explained below. catheter It can be used together with other items. Guide wire 100 is the patient's vascular system catheter It can be configured to facilitate insertion. Guide wire 100 includes a distal section 110 extending to a distal end 101 and a proximal section 120 extending to a proximal end 102.

[0023] The distal section 110 can be configured to be positioned within the patient's vascular system. In some embodiments, the distal section 101 is configured to traverse the vascular system. Guide wireIt may have a flexibility that matches the distal section. Thus, the distal section 110 can have sufficient flexibility to pass through the vascular system without damaging the vessel wall. In other words, the distal section 110 can be bent during insertion to conform to the vascular structure without plastic deformation, twisting, and / or breakage. The distal section 110 can also have sufficient rigidity to facilitate insertion by compressive forces applied distally without buckling within the vascular system. In some embodiments, the distal section 110 may have sufficient length to extend from the vascular insertion site to a desired location within the vessel, such as the lower third of the superior vena cava ("SVC") of the heart. Thus, the placement of the intravascular device is intravascular Guide wire as Guide wire It may include the use of 100. The distal section 110 is catheter It can also have a circular cross-section with a diameter of 111, suitable for insertion through the vascular system.

[0024] In some embodiments, the distal section 110 may have a pre-formed shape 112, such as a non-traumatic tip, to assist in insertion through the vascular system. In some embodiments, the pre-formed shape 112 is Guide wire During the advance and / or retraction of the 100, it helps to prevent injury or damage to the soft tissues of the vascular system. In some embodiments, the pre-formed shape 112 includes a curved portion adjacent to the distal tip 101. The curved portion is Guide wire The distal extension of the longitudinal axis Guide wire It may be configured to intersect with. In such an embodiment, Guide wire The curved portion is brought into contact with the blood vessel wall, thereby preventing direct contact between the distal tip 101 and the blood vessel wall. The distal section 110 has a length of 123.

[0025] The proximal section 120 is, catheterIt can be configured to be manually inserted into the lumen. The proximal section 120 may be configured to be manually operated by a clinician, and the proximal section 120 may be configured to be inserted without plastic deformation, twisting, and / or breakage. catheter It can have bending stiffness that facilitates manual displacement distally inward. The stiffness of the proximal section 120 is catheter This can increase the rigidity of the patient, that is, the patient catheter To assist in the insertion, catheter Column strength can be imparted to it. The proximal section 120 is catheter It may have a diameter 124 such that the proximal section 120 can be positioned inside. In some embodiments, the diameter 124 may be the same as, greater than, or less than the diameter 114 of the distal section 110. In some embodiments, the proximal section 120 may be configured to be at least partially positioned within the patient's vascular system. In some embodiments, the length 125 of the proximal section 120 may be longer than the length 123 of the distal section 110.

[0026] In some embodiments, the proximal section 120 may have an indicia 128. The indicia 110 may indicate the distance to the distal end 126 of the proximal section 120. catheter The distal end may not be visible to the clinician, as is the case when the distal end is located within the patient. catheter At the position of mark 128 relative to the proximal end, catheter The position of the distal end 126 of the proximal section 120 relative to the distal end of can be indicated. Mark 110 also indicates Guide wire The distance from 100 to its distal end 101 can be indicated. In some cases, a clinician can observe the mark 128 to determine the position of the distal end 101 along the patient's vascular system.

[0027] The proximal section 120 may have a distal transition portion 122. The distal transition portion 122 can define a smooth transition of physical properties between the distal section 110 and the proximal section 120. The distal transition portion 122 may have a tapered portion for transitioning the diameter 114 of the distal section 110 to the diameter 124 of the proximal section 120. The distal transition portion 122 can also be configured to transition the flexibility of the distal section 110 to the rigidity of the proximal section 120. In some embodiments, the distal transition portion 126 can define a tension relief portion.

[0028] Figure 1B shows Guide wire One embodiment of the structure 100 is shown. Guide wire 100 is Guide wire Solid core extending in the longitudinal direction of 100 wire It can be composed of 130. In some embodiments, a solid core wire 130 can be formed from nitinol material. Solid core wire 130 corresponds to the distal section 110 and the proximal section 120, respectively. wire Part 131 and proximal wire Includes part 132. Distal wire The portion 131 may have a narrow diameter 134 that conforms to the flexibility of the distal section 110. wire The portion 132 may include a thicker diameter 135 that matches the stiffness of the proximal section 120. In the illustrated embodiment, the stiffness of the proximal section 120 is that of a solid core wire 130 proximal wire Part 132 can be defined by its bending stiffness. Bending stiffness is understood as the product of the material's modulus of elasticity (E) and its second moment of area (I), and the SI unit of bending stiffness (EI) is Newtons (N)·meter. 2 (m 2 ) or N·m 2 In the case of a solid circular cross-section, (I) is defined by the following equation 1 (where (d) is the diameter of the circular cross-section). In the illustrated embodiment, (d) is a solid core wire The proximal portion 132 of 130 may have a thicker diameter 135.

[0029]

number

[0030] solid core wire teeth, Guide wire It can include 100 alternative structures. For example, a solid core. wire 130 is, Guide wire Along a length of 100, it can have a constant diameter such as 134. Central core wire proximal wire Part 132 defines the diameter 124 of the proximal section 120 and the central core wire To add rigidity to the 130, the central core wire This may include a cannula positioned and attached around 130. Other alternative structures that a person skilled in the art could conceive of are also considered part of this disclosure.

[0031] Figure 2 is the same as Figure 1A. Guide wire Includes 100 catheterAssembly 200 is shown. In some embodiments, Figure 2 is in a ready-to-place state. catheter Assembly 200 is shown. As shown in the figure, catheter Assembly 200 is joined together catheter Includes 202 and introducer 206. catheter 202 is, catheter A single-lumen or multi-lumen vessel including at least a primary lumen 208 extending through 202 catheter That's fine. catheter 202 is flexible catheter Tube 220 and, catheter Hub 222 and soft catheter The tube 220 includes one or more extension legs 224 corresponding to one or more lumens that extend at least partially through the tube 220. In the illustrated embodiment, the primary lumen 208 corresponds to the primary legs 228. catheter Tube 220 is, catheter Flexible part corresponding to the distal end of 202 catheter The distal end portion of the tube 220 is surrounded by the distal tip 230.

[0032] The introducer 206 is an introducer catheter Includes 232 and introduction needle 226. Introducer catheter 232 is an introducer catheter Tube 234 and this catheter Induction device around the proximal end portion of tube 234 catheter Hub 236 and introduction device catheter The introducer 206 includes the distal tip 238 at the distal end of the tube 234. catheter So that tube 234 is positioned inside the primary lumen 208, catheter It is coupled to 202. Once coupled, the introducer catheter Tube 234 is 1) catheter It extends distally beyond the distal tip 230, and also extends proximal beyond the proximal end of the primary leg 228.

[0033] In some embodiments, catheter 202 is flexible catheter It extends through the wall of tube 220 into the primary lumen 208, and further into the introduction device catheterThe inlet passes through the wall of tube 234. catheter The 232 includes a lateral opening 204 extending into a single lumen. The introduction needle 226 passes through the lateral opening 204 into the introduction device. catheter The 232 is positioned within a single lumen, and the angled tip 246 of the introduction needle 126 is positioned within the introduction device to establish percutaneous puncture. catheter The distal tip 238 of 232 is extended beyond the distal tip 238. In some embodiments, the side opening 204 may be omitted, and the introduction needle 226 is an introduction device. catheter Introducer via hub 236 catheter It may be inserted into 232.

[0034] In some embodiments, catheter Assembly 100 is accessed Guide wire (access Guide Wire ) may further include 248, and access Guide wire 248 can be positioned within the needle lumen of the introduction needle 226 such that its distal end is proximal to the oblique tip 246 of the introduction needle 226, thereby access Guide wire The distal end of 248 can advance immediately into the vascular system, passing beyond the angled tip 246 of the introduction needle 226 to establish access to the vascular system. In other embodiments, access Guide wire 248 can be omitted.

[0035] As mentioned above, catheter Assembly 200 is by several embodiments Guide wire Includes 100. In the illustrated embodiment, Guide wire 100 is Guide wire The distal end 101 of 100 is proximal to the lateral opening 204. catheter The introducer is distal to hub 222. catheter It can be placed in a single lumen of 232. This allows the introduction device catheter When the introduction needle 226 is withdrawn from the lumen of 232, Guide wire The distal end 101 of 100 can be immediately advanced into the vascular system. In some embodiments, Guide wire The proximal section 120 of 100 is the introducer. catheterIt may be located near the hub 236. In some embodiments, Guide wire Part of the 100 distal sections 110 is also an induction device. catheter It may be located proximal to the hub 236. In other embodiments, part of the proximal section 120 is an introducer catheter It may be placed in a single lumen of 232. In some embodiments, catheter When assembly 200 is ready for placement, Guide wire 100 is the introducer catheter It does not need to be inserted into a single lumen of 232.

[0036] In some embodiments, the length 125 of the proximal section 120 is catheter From the proximal end catheter It can have a length sufficient to extend to the distal end. In some embodiments, the length 125 is such that the distal end 126 of the proximal section 120 is catheter When positioned adjacent to the distal end, a portion of the proximal section 120 catheter It may be long enough to extend proximally away from the proximal end. The extended portion of the proximal section 120 may be long enough so that a clinician can grasp and manipulate the proximal section 120.

[0037] Figures 3A, 3B, and 3D show the first, second, and third states of insertion into the patient, respectively, according to several embodiments. catheter Figure 3A shows assembly 200. The introduction needle 226 is in the first insertion state, having punctured the skin of patient 300 at skin puncture site 305. catheter The assembly 200 is shown. The introduction needle 226 also punctures the blood vessel 310 at the vascular puncture site 312 to establish the needle pathway. catheter 232 also introduced catheter The distal tip 238 of 232 is inserted together with the introduction needle 226 so that it is positioned within the blood vessel 310. Guide wire 248 is introduced catheter It is withdrawn from 232 and the side opening 204. Guide wire 100 is Guide wireThe distal end 101 of 100 is advancing distally, extending beyond the distal tip 238 into the blood vessel 310.

[0038] Figure 3B shows the second insertion state. catheter 202 remains in the same position as shown in Figure 3A. Referring to both Figures 3B and 3C, Guide wire 100 is the introduction device with the distal end 126 of the proximal section 120 adjacent to the vascular puncture site 312. catheter It is advancing distally so as to be positioned within tube 234. The distal section 110 is positioned within blood vessel 310. Guide wire The proximal section 120 of section 100 is catheter It is positioned along the entire length of 202. In other words, the proximal section 120 is located from the vascular puncture site 312. catheter It extends proximally beyond the proximal end of 202. Guide wire 100 proximal section 120, catheter Since it is arranged along the entire length of the 202, Guide wire Due to its rigidity, catheter To facilitate the insertion of tube 220 into blood vessel 310, catheter This imparts additional rigidity, i.e., column strength, to 202. In some cases, catheter The distal tip 230 of 202 may cause dilation of the skin puncture site 305 and the vascular puncture site 312. In such cases, catheter The force required to insert section 202 can be matched by the enhanced rigidity provided by the proximal section 120.

[0039] Refer specifically to Figure 3C, catheter In the skin and vascular puncture sites 305 and 312 when 202 is in the second insertion state catheter Distal section and induction device of 202 catheter Detailed cross-sectional views of 232 are shown. Introducer catheter It is shown that the tube 234 is positioned through the skin puncture site 305 and the vascular puncture site 312. catheterThe distal tip 230 of 202 remains proximal to the skin and vascular puncture sites 305 and 312. Guide wire It is shown that the proximal section 120 of 100 extends into the vessel 310, and the distal portion 126 of the proximal section 120 is located slightly distal to the vascular puncture site 312. In some cases, when the distal portion 126 is adjacent to (proximally adjacent to) the vascular puncture site 312, Guide wire The distal end 101 of 100 may be located within the SVC, and therefore, Guide wire Further distal advancement of 100 units may be undesirable for the patient.

[0040] Figure 3D shows, catheter 202 indicates a third insertion state in which it is inserted into blood vessel 310. catheter The distal tip 230 of 202 is inserted into the blood vessel 310. In this third state, the skin puncture site 305 and the blood vessel puncture site 312 may be expanded by the tapered portion of the distal tip 230 during insertion. catheter The proximal section 120 positioned along 202 can provide column strength to facilitate insertion of the distal tip 230 and dilation of the skin puncture site 305 and vascular puncture site 312 by the distal tip 230.

[0041] Figure 3E shows, catheter When 202 is in the third insertion state, at the skin and vascular puncture sites 305, 312 catheter Distal section and induction device of 202 catheter This is a detailed cross-sectional view of the 232. Guide wire 100 is retracted proximally such that the distal portion 126 of the proximal section 120 is positioned adjacent to (close to) the vascular puncture site 312. Therefore, the introducing device catheter The proximal section 120, which extends proximal to the hub 236, is longer in the third insertion state shown in Figure 3C than in the second insertion state shown in Figure 3B.

[0042] In some embodiments, as shown in Figures 3B and 3D catheter The process of inserting 202 is catheterThis may be repeated multiple times during the insertion of 202. In other words, the distal end 126 remains adjacent to the vascular puncture site 312, 1) catheter 1) The step of inserting it by a certain distance, and 2) Guide wire 100 catheter The step of moving backward by a corresponding distance relative to 202 is: catheter The insertion of 202 to its intended final position can be repeated once or multiple times. method Any method disclosed herein includes one or more steps or actions for performing the described method. The method steps and / or actions may be interchangeable. In other words, the order and / or use of any particular steps and / or actions may be changed unless a particular order of steps or actions is required for the proper operation of the embodiment. Furthermore, only a portion of the subroutines or methods described herein may constitute a separate method within the scope of this disclosure. In other words, some methods may include only a portion of the steps described in a more detailed method.

[0043] Guide wire The method of using 100 may include the following steps or processes. This method is catheter Before inserting the 202 into the patient, catheter In the lumen 202, 208 Guide wire The step may include inserting 100. In some embodiments, Guide wire The distal end 101 of 100 is positioned within the lumen 208. Guide wire It can enter the lumen 208 at the proximal end of the lumen 208. In some embodiments, Guide wire The distal portion of the distal section 110 of 100 can be placed inside the lumen 208, while the proximal portion of the distal section 110 is placed outside the lumen 208. In other embodiments, the entire distal section 110 can be placed inside the lumen 208. In some embodiments, the distal portion of the proximal section 120 can be placed inside the lumen. In some embodiments, catheterAfter inserting the 202 at least partially into the patient, catheter In the lumen 208 of 202 Guide wire 100 is inserted.

[0044] In some embodiments, catheter This is an introduction device placed inside the lumen 208. catheter Induction device with a lumen catheter 232 may be included. In such embodiments, the insertion step is, Guide wire 100 Introducer catheter The step may include inserting into the lumen. Guide wire The distal end 101 of 100 is the introducer. catheter It is placed inside the lumen. Guide wire The introduction device catheter The inlet is placed at the proximal end of the lumen. catheter It can enter the lumen. In some embodiments, Guide wire The distal section of 100 and the distal portion of 110 are introduced into the device. catheter It may be placed inside the lumen, while the proximal portion of the distal section 110 is an induction device. catheter It is positioned outside the lumen. In other embodiments, the entire distal section 110 is used as an introducer. catheter It can be placed inside the lumen. In some embodiments, the distal portion of the proximal section 120 is used as an introducer. catheter It can be placed inside the lumen.

[0045] The method is, Guide wire (introducing Guide Wire )248 introduced catheter The step of inserting into the lumen may be further included. Guide wire 248 is an introducer catheter It can be inserted through the side opening 204 that enters the lumen. Guide wire 248 is an introducer catheter Further insertion distally through the lumen, and introduction Guide wire The distal end of 248 is the induction device. catheter The introducer between the side opening 204 and the distal tip 238 of 232 catheter It may be positioned so as to be located within the lumen.

[0046] The method may further include the step of establishing a needle pathway from a region of the patient's skin 300 to a blood vessel 310 using the inclined tip 246 of the introduction needle 226. In some embodiments, the method may include the step of advancing the introduction needle 226 through a lateral opening 204, as shown in Figure 3A. catheter As described above regarding the ready-to-place state of assembly 200, the guide needle 226 is catheter 202 flexibility catheter Extending through the side opening 204 of tube 220, introducer catheter 232 introducers catheter It extends through the side of tube 234, and then into the inlet. catheter It can exit from the distal tip 238 of 232.

[0047] The method is access Guide wire The step of advancing the 248 from the introduction needle 226 into the patient's blood vessel 310 may further include. The method is, introducer catheter Access the distal end portion of 232 Guide wire This may further include steps to advance beyond 248 into blood vessel 310.

[0048] The method is access Guide wire 248 and introducer catheter With 232 still inserted into the blood vessel 310, the introduction needle 226 is inserted into the blood vessel 310 and catheter The procedure may further include the step of pulling the assembly 200 from both sides.

[0049] The method is, introducer catheter Entering blood vessel 310 via 232 Guide wire The step of advancing 100 may further be included. In some embodiments, Guide wire The first step to advance 100 is to first insert the blood vessel 310, the lumen 208, and the introducer. catheter This may include withdrawing the introduction needle 226 from 232.

[0050] The method is, Guide wire The proximal section 120 has a stiffness of 100. catheter It is placed within 202, and thereby catheter To add rigidity to 202, introducer catheter via Route 232 Guide wire It can include further steps to advance the 100.

[0051] The method is, Guide wire The distal end 126 of the proximal section 120 of 100 catheter So that it is positioned adjacent to the distal tip 230 of 202, catheter Inside 202 Guide wire The procedure may further include the step of positioning 100.

[0052] The method is, Guide wire The distal end 126 of the rigid proximal section 120 is positioned adjacent to the vascular puncture site 312. Guide wire 100 catheter The step of positioning within 202 may be further included.

[0053] The method is, Guide wire 100 proximal section 120 and catheter While simultaneously gripping 202, introducer catheter 232 and catheter The procedure may further include the step of advancing both of the 202s a first distance further into the blood vessel 310.

[0054] The method is, Guide wire The distal end 126 of the proximal section 120 of 100 is repositioned adjacent to the vascular puncture site 312. Guide wire 100 catheter The procedure may further include a step of moving the object back by a first distance in the proximal direction within 202.

[0055] The method involves the vascular system Guide wire Along 100 catheter Further steps to advance 202 could be included. The method is, Guide wire 100 catheter The step of removing from 202 may be further included.

[0056] The method is, catheter Introduced from 202 catheter The step of removing 232 may be further included. While several specific embodiments are disclosed herein, and some embodiments are disclosed in some degree of detail, no particular embodiment is intended to limit the scope of the concepts provided herein. Additional adaptations and / or modifications may be obvious to those skilled in the art, and in broader embodiments, these adaptations and / or modifications are also encompassed. Thus, one can deviate from any particular embodiment disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. A guide wire, A solid core wire including a proximal section, a distal section, and a transition section defining the transition between the proximal and distal sections, A guidewire comprising: a coil wound around the distal section of a solid core wire, but not around the transition section and the proximal section, wherein the proximal section has a bending stiffness less than that of the distal section, and the distal section includes a pre-formed curved distal tip, the distal tip being configured to intersect with the extension of the longitudinal axis of the distal section of the guidewire.

2. The guide wire according to claim 1, wherein the diameter of the proximal portion of the solid core wire is greater than the diameter of the distal portion of the solid core wire.

3. The guidewire according to claim 1 or 2, wherein the distal section is configured to be inserted into the patient's vascular system.

4. The guidewire according to any one of claims 1 to 3, wherein the distal section is configured to guide the catheter along the patient's vascular system.

5. The guidewire according to any one of claims 1 to 4, wherein the proximal section is configured to be inserted through a catheter, and the proximal section imparts column strength to the catheter.

6. The guidewire according to any one of claims 1 to 5, wherein the guidewire is configured such that, during insertion, the proximal section provides column strength to the proximal portion of the catheter, while the distal section guides the distal portion of the catheter along the patient's vascular system.

7. The guidewire according to any one of claims 1 to 6, wherein the bending rigidity of the proximal section is configured to allow manual displacement of the proximal section into the catheter without twisting or breakage.

8. The guide wire according to any one of claims 1 to 7, wherein the proximal portion of the solid core wire defines the outer diameter of a part of the guide wire.

9. The guidewire according to any one of claims 1 to 8, wherein the proximal section is longer than the distal section.

10. A guidewire according to any one of claims 1 to 9, further comprising a non-traumatic distal tip.

11. A catheter assembly, Catheter and, The catheter comprises a guidewire that is at least partially positioned through the lumen of the catheter, the guidewire including a solid core wire, A distal section having a first diameter, A proximal section having a second diameter, A transitional section that defines the transition between the proximal and distal sections, A catheter assembly comprising a coil wound around the distal section of a solid core wire, but not around the transition section and the proximal section, wherein the distal section includes a pre-formed curved distal tip, the distal tip being configured to intersect the extension of the longitudinal axis of the distal section of the guidewire, and the second diameter being greater than the first diameter.

12. The catheter assembly according to claim 11, wherein the length of the distal section of the guidewire is shorter than the length of the catheter.

13. The catheter assembly according to claim 11 or 12, wherein the length of the proximal section of the guidewire is longer than the length of the catheter.

14. The catheter assembly according to any one of claims 11 to 13, wherein the distal end of the guidewire is positioned within the lumen.

15. The catheter assembly according to any one of claims 11 to 14, wherein, when in use, the distal section of the guidewire extends distally beyond the distal end of the catheter, and the proximal section of the guidewire is positioned through the lumen.

16. An introduction catheter that is positioned through the lumen, and an introduction catheter having an introduction catheter lumen, The catheter assembly according to any one of claims 11 to 15, further comprising an introduction needle positioned at least partially through the lumen of the introduction catheter.

17. The catheter assembly according to claim 16, wherein the introduction needle is positioned to pass only through the distal portion of the lumen of the introduction catheter, and the guidewire is positioned to pass through the proximal portion of the lumen of the introduction catheter.

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