Assembly and method for introducing additional guide wires

Abstract

A medical system for connecting to a pre-introduced guidewire during an internal procedure comprises an auxiliary guidewire and a single-lumen tubular section having a radial wall fixedly engaged with the longitudinal portion of the auxiliary guidewire. The radial wall defines a passage having dimensions such that the pre-introduced guidewire can slide through it. The tubular section and the engaged longitudinal portion of the auxiliary guidewire are not coaxially engaged.

Description

[Technical Field]

[0001] Cross-reference of related applications

[0002] This patent application claims the interests of U.S. Provisional Patent Application No. 63 / 447,904, filed on 24 February 2023, which is incorporated herein by reference in its entirety.

[0003] Embodiments of the present invention generally relate to medical devices, and more particularly to a method and apparatus for introducing a second guidewire into a guidewire pre-installed in the lumen of a subject. [Background technology]

[0004] Guidewires are used for navigation to reach locations within a patient, such as surgical sites or other treatment sites. Once the tip of the guidewire reaches its destination, it acts as a guide for larger elements, such as catheters, to quickly follow, facilitating delivery to the treatment site. Introducing an additional guidewire parallel to a pre-introduced guidewire can be useful in many different procedures.

[0005] To ensure that the second guidewire follows the same path as the first guidewire, a coupling device can be used for introduction. Such coupling tips have been plagued by numerous design flaws. The most serious flaws include: the path provided to the pre-introduced guidewire through the coupling tip is not uniformly parallel to, or nearly parallel to, the second guidewire; the path provided to the pre-introduced guidewire through the coupling tip is not fixed in orientation relative to the second guidewire, i.e., its orientation can change when an external force is applied to the coupling device; the path provided to the pre-introduced guidewire through the coupling tip is not uniformly straight, i.e., the pre-introduced guidewire is forced to bend at multiple points as the coupling device moves along the length of the guidewire; the path provided to the pre-introduced guidewire through the coupling tip is too short; and the passage provided within the coupling tip for the distal end of the second guidewire cannot accommodate the diameter of the guidewire. Any or all of these design flaws could mean that when introducing a second guidewire using such a connecting tip, the surgeon may encounter resistance, inadvertently causing shear force on the pre-introduced guidewire or forcibly detaching the connecting device from the second guidewire.

[0006] Therefore, there is a need for a guidewire assembly that is as effective as a connecting tip while eliminating the aforementioned disadvantages. [Overview of the project] [Means for solving the problem]

[0007] According to the embodiments disclosed in this specification, a medical system for connecting to a guide wire pre-introduced during an in-vivo procedure includes: (a) an auxiliary guide wire, and (b) a single-lumen tubular portion having a radial wall fixedly engaged to a longitudinal portion of the auxiliary guide wire, wherein the radial wall defines a passage having a dimension such that the pre-introduced guide wire can slidably pass therethrough, and the tubular portion and the engaged longitudinal portion of the auxiliary guide wire are not coaxially engaged.

[0008] In some embodiments, the tubular portion and the auxiliary guide wire may not be coaxial. In some embodiments, the central longitudinal axis of the auxiliary guide wire may be parallel to the central longitudinal axis of the tubular portion. In some embodiments, the central longitudinal axis of the auxiliary guide wire may be laterally displaced from the central longitudinal axis of the tubular portion. In some embodiments, the lateral displacement is at least 5% or at least 10% of the inner diameter of the tubular portion. In some embodiments, the lateral displacement is at least 15% or at least 20% of the inner diameter of the tubular portion. In some embodiments, the lateral displacement is at least 25% or at least 30% of the inner diameter of the tubular portion. In some embodiments, the lateral displacement is at least 35% or at least 40% of the inner diameter of the tubular portion. In some embodiments, the lateral displacement is at least 45% or at least 50% of the inner diameter of the tubular portion. In some embodiments, the lateral displacement is more than 50% of the inner diameter of the tubular portion. In some embodiments, the central longitudinal axis of the engaged longitudinal portion of the auxiliary guide wire may be parallel to the central longitudinal axis of the tubular portion and laterally displaced therefrom.

[0009] In some embodiments, the engaged longitudinal portion of the auxiliary guide wire may be at least partially embedded longitudinally in the radial wall of the tubular portion.

[0010] In some embodiments, the fixed engagement between the tubular portion and the longitudinal portion includes at least one of molding, overmolding, extrusion, welding, thermal welding, adhesion, soldering, and fusing. In some embodiments, the tubular portion may be molded and / or extruded to at least partially embed the longitudinal portion of the auxiliary guide wire into the radial wall.

[0011] In some embodiments, a majority of the circumferential angular portion of the engaged longitudinal portion is in fixed contact with the radial wall. In some embodiments, at most a minority of the circumferential angular portion of the engaged longitudinal portion is in fixed contact with the radial wall. In some embodiments, the engaged longitudinal portion of the auxiliary guide wire includes the distal end of the auxiliary guide wire. In some embodiments, the engaged longitudinal portion of the auxiliary guide wire is not non-destructively separable from the tubular portion.

[0012] According to an embodiment, a method for using a plurality of guide wires is disclosed. The method includes (a) providing a medical system according to any of the embodiments of the medical system described above, (b) locating the proximal end of a pre-introduced guide wire, (c) slidably passing the tubular portion of the medical system over the proximal end of the pre-introduced guide wire such that the proximal end enters and exits the distal opening of the tubular portion, and (d) advancing the medical system distally over the pre-introduced guide wire.

[0013] According to the embodiment, a method for connecting to a pre-introduced guidewire during an in-vivo procedure is disclosed, the method comprising: (a) providing a medical system comprising an auxiliary guidewire and a single-lumen tubular portion having a radial wall fixedly and non-coaxially engaged with the longitudinal portion of the auxiliary guidewire; (b) locating the proximal end of the pre-introduced guidewire; (c) sliding the tubular portion of the medical system over the proximal end of the pre-introduced guidewire such that the proximal end enters and exits the distal opening of the tubular portion; and (d) advancing the medical system distally over the pre-introduced guidewire.

[0014] In some embodiments of the method, the tubular portion and the auxiliary guide wire do not have to be coaxial. In some embodiments, the central longitudinal axis of the auxiliary guide wire may be parallel to the central longitudinal axis of the tubular portion. In some embodiments, the central longitudinal axis of the auxiliary guide wire may be displaced laterally from the central longitudinal axis of the tubular portion. In some embodiments, the central longitudinal axis of the engaged longitudinal portion of the auxiliary guide wire may be parallel to the central longitudinal axis of the tubular portion and displaced laterally from there.

[0015] In some embodiments, the engaged longitudinal portion of the auxiliary guide wire may be at least partially embedded longitudinally in the radial wall of the tubular portion. In some embodiments, the tubular portion may be molded and / or extruded such that the longitudinal portion of the auxiliary guide wire is at least partially embedded in the radial wall.

[0016] In some embodiments, the angular majority of the circumference of the longitudinal portion is in fixed contact with the radial wall. In some embodiments, the engaged longitudinal portion of the auxiliary guidewire includes the distal end of the auxiliary guidewire. In some embodiments, the engaged longitudinal portion of the auxiliary guidewire is not nondestructively separable from the tubular portion.

[0017] Brief explanation of the drawing

[0018] The present invention will be further described by reference to the accompanying drawings. The dimensions of the components and features shown in the drawings have been selected for convenience and clarity of representation and are not necessarily to scale. [Brief explanation of the drawing]

[0019] [Figure 1A] Figure 1A shows a schematic partial side view of a guide wire assembly according to an embodiment of the present invention.

[0020] [Figure 1B-1C] Figures 1B and 1C schematically show cross-sections of various non-limiting examples of guidewire assemblies according to embodiments of the present invention.

[0021] [Figure 2A] Figure 2A shows a schematic partial side view of a second guide wire according to an embodiment of the present invention.

[0022] [Figure 2B] Figure 2B shows additional features of the guidewire assembly shown in Figure 1A.

[0023] [Figure 2C] Figure 2C shows the second guide wire of Figure 2A passing through the tubular portion of the guide wire assembly of Figures 1A and 2B, according to an embodiment of the present invention.

[0024] [Figure 3A-3B] Figures 3A, 3B, 4, 5, 6A, 6B, and 7A show schematic partial side views of a guide wire assembly according to an embodiment of the present invention. [Figure 4] Figures 3A, 3B, 4, 5, 6A, 6B, and 7A show schematic partial side views of a guide wire assembly according to an embodiment of the present invention. [Figure 5] Figures 3A, 3B, 4, 5, 6A, 6B, and 7A show schematic partial side views of a guide wire assembly according to an embodiment of the present invention. [Figure 6A-6B]Figures 3A, 3B, 4, 5, 6A, 6B, and 7A show schematic partial side views of a guide wire assembly according to an embodiment of the present invention. [Figure 7A] Figures 3A, 3B, 4, 5, 6A, 6B, and 7A show schematic partial side views of a guide wire assembly according to an embodiment of the present invention.

[0025] [Figure 7B] Figure 7B shows a schematic top view of a guide wire used in the assembly shown in Figure 7A, according to an embodiment of the present invention.

[0026] [Figures 8A-8B] Figures 8A and 8B show schematic partial side views of a guide wire assembly according to an embodiment of the present invention.

[0027] [Figure 8C] Figure 8C shows a schematic top view of the guide wire assembly shown in Figure 8A, according to an embodiment of the present invention.

[0028] [Figure 8D] Figure 8D shows a schematic side view of the guide wire assembly of Figure 8A, in which the second guide wire passes through the tubular portion of the guide wire assembly, according to an embodiment of the present invention.

[0029] [Figure 9A] Figure 9A shows a schematic side view of a guide wire for use in a guide wire assembly according to an embodiment of the present invention.

[0030] [Figure 9B-9C] Figures 9B and 9C show schematic side views of a guide wire assembly including the guide wire shown in Figure 9A, according to an embodiment of the present invention.

[0031] [Figure 9D] Figure 9D shows a schematic top view of a guide wire assembly including the guide wire shown in Figure 9A, according to an embodiment of the present invention.

[0032] [Figure 10] Figure 10 shows a schematic side view of the guide wire assembly of Figures 9B and 9C, according to an embodiment of the present invention, in which the second guide wire passes through the tubular portion of the guide wire assembly.

[0033] [Figure 11] Figures 11 and 12 show flowcharts of methods using multiple guide wires according to the embodiment of the present invention. [Figure 12] Figures 11 and 12 show flowcharts of methods using multiple guide wires according to the embodiment of the present invention.

[0034] [Figures 13A-13B] Figures 13A, 13B, 13C, and 13D illustrate steps of a method for connecting a guidewire assembly to a pre-introduced second guidewire during a medical procedure, according to an embodiment of the present invention. [Figures 13C-13D] Figures 13A, 13B, 13C, and 13D illustrate steps of a method for connecting a guidewire assembly to a pre-introduced second guidewire during a medical procedure, according to an embodiment of the present invention. [Modes for carrying out the invention]

[0035] The present invention will be described herein, as an example, with reference to the accompanying drawings. With further detailed reference to the drawings, it is emphasized that the details shown are illustrative and for illustrative purposes only, and are presented for illustrative purposes only, for illustrative discussion of preferred embodiments of the invention, and are intended to provide an explanation of the principles and conceptual aspects of the invention that is believed to be most useful and readily understandable. In this regard, no attempt has been made to show the structural details of the invention in more detail than is necessary for a basic understanding of the invention, and by reading the description together with the drawings, it will become clear to those skilled in the art how some forms of the invention may be carried out. Throughout the drawings, similar reference numerals are generally used to designate similar elements.

[0036] As used herein and in the accompanying claims and drawings, the terms “guidewire assembly” and “medical system” are equivalent and interchangeable. As used herein and in the accompanying claims and drawings, the terms “first guidewire” and “second guidewire” mean a guidewire incorporated into a guidewire assembly / medical system according to the disclosed embodiment, and a guidewire pre-introduced into a cavity or lumen, respectively. The term “supplemental guidewire” is equivalent and interchangeable with “first guidewire.” The term “previously-introduced guidewire” is equivalent and interchangeable with “second guidewire.” The term “engaged with” means attached to, affixed to, integrated with, etc.

[0037] The terms “distal” and “proximal” are used in this disclosure and the appended claims as follows: “Distal” means further into the body (along the insertion path) from the point of entry into the body, and “proximal” means closer to the point of entry into the body. When these terms are used in reference to devices outside the patient’s body, the distal portion or distal end may be the part or end of the device configured to be inserted into the body first, such as the tubular portion of a guidewire assembly, while the proximal end or proximal portion may be the last to be inserted (or not inserted at all). In addition, or alternatively, when these terms are used in reference to devices outside the patient’s body, the distal portion or distal end may be the part further away from or furthest from the user grasping the device, while the corresponding proximal portion or proximal end may be the part closer to or closest to the user grasping the device. In addition, when used relatively, for example, "distally displaced from" or "proximal of" means "closer to the distal end than" or "closer to the proximal end than," respectively. The respective distal and proximal directions are shown in many diagrams, and in all relevant diagrams, the convention of "distal to the left" and "proximal to the right" is maintained.

[0038] The terms “first” and “second” with respect to the respective parts of the guidewire and connecting device are used in accordance with the following conventions throughout this disclosure and the appended claims: “first guidewire” means a guidewire that is part of a guidewire assembly that can be connected by a surgeon to a pre-introduced guidewire in the patient’s lumen. The pre-introduced guidewire is therefore referred to as “second guidewire.”

[0039] Referring here to the drawings, particularly Figures 1A, 1B, and 1C, the guidewire assembly 100 includes a first guidewire 10 and a tubular section 25. The guidewire assembly 100 is provided to connect the first guidewire 10 to a second guidewire already introduced into the lumen, such as the second guidewire 20 in Figures 2A-B. The tubular section 25 and the second guidewire are selected so that the second guidewire can slide through the interior of the tubular section 25.

[0040] A non-limiting example of the guidewire assembly 100 schematically shown in Figure 1A shows a tubular section 25 fixedly engaged with the distal portion 110 of the first guidewire 10. The respective distal and proximal directions are indicated by the arrows 1000 in Figure 1A. For convenience, the convention of distal = left, proximal = right is maintained throughout Figures 2A, 2B, 3, 4, and 5. The tubular section 25 and the guidewire 10 in Figure 1A cannot be separated or removed non-destructively. Methods of attachment included in the definition of “fixedly engaged” include, but are not limited to, molding, overmolding, extrusion, welding, thermal welding, bonding, soldering, and fusion.

[0041] In the embodiment, the tubular portion 25 may be formed from a flexible or elastic material such as a polymer or metal (or metal alloy), or from a superelastic material such as nitinol. The mounting method for fixed engagement can be selected according to the selected material. Alternatively, the material of the tubular portion 25 can be selected according to the preferred mounting method.

[0042] The tubular portion 25 is intended to enable the guide wire assembly 100 to slide along a second guide wire (which is a pre-introduced guide wire), and is made to be long enough so that it is not particularly difficult to slide the guide wire assembly 100 without damaging or immobilizing the second guide wire. Thus, the tubular portion 25 has both a minimum length and a minimum length-to-diameter ratio according to the embodiment, and their combination improves the ability of the guide wire assembly 100 to safely and effectively cross the second guide wire. The tubular portion 25 has a length indicated by arrow L in FIG. 1A 25 and an inner diameter indicated by ID 25 . In an embodiment, the length L 25 is preferably at least 1 cm. In some embodiments, the length L 25 is at least 2 cm. In other embodiments, the length L 25 is at least 3 cm. In still other embodiments, the length L25 is at least 4 cm. In some embodiments, the length L 25 is 1 - 2 cm, or 1 - 3 cm, or 1 - 4 cm, or 1 - 5 cm, or 2 - 3 cm, or 2 - 4 cm, or 2 - 5 cm, or 3 - 4 cm, or 3 - 5 cm, or more. All ranges recited in this disclosure (and the appended claims) are inclusive ranges.

[0043] In an embodiment, the inner diameter ID 25 is at least 0.95 mm and 2 mm or less. In some embodiments, the inner diameter ID 25 is at least 0.95 mm and 3 mm or less. In some other embodiments, the inner diameter ID 25 is at least 0.5 mm and 2 mm or less. In some other embodiments, the inner diameter ID 25 is at least 0.5 mm and 1.5 mm or less. In still other embodiments, the inner diameter ID 25 is at least 0.5 mm and 3 mm or less. In still other embodiments, the inner diameter ID 25It is at least 0.2 mm and 2 mm or less. In other embodiments, the inner diameter ID 25 It is at least 0.2 mm and less than or equal to 1 mm. In other embodiments, the inner diameter ID 25 It is at least 0.2 mm and no more than 3 mm.

[0044] Length L 25 and inner diameter ID 25 The ratio is between 100:1 and 5:1, or between 50:1 and 5:1, or between 30:1 and 5:1, or between 100:1 and 10:1, or between 50:1 and 10:1, or between 30:1 and 10:1, or between 100:1 and 30:1, or between 50:1 and 30:1.

[0045] Figure 1B shows exemplary cross-sectional views of guidewire assemblies 100 according to various embodiments in which the engaging distal portion 110 of the guidewire 10 is at least partially embedded longitudinally in the radial wall 22 of the tubular portion 25. The radial wall 22 defines a passage 28 having dimensions such that a guidewire (not shown in Figure 1B) can slide through it, such as a guidewire pre-introduced into a cavity or lumen. The embedding can be achieved, for example, by molding, i.e., overmolding or extruding, the radial wall 22 of the tubular portion 25 onto the distal portion 110 of the guidewire 10 using a thermosetting polymer. Figure 1B shows the respective cross-sectional views 100. A , 100 B , 100 C In each of the first three examples shown, the engaged longitudinal portion of the first guidewire has a diameter smaller than the thickness of the radial wall 22. Guidewire assembly 100 A , 100 B , 100 CRegarding this, it can be seen that the majority of the circumference of the engaged longitudinal portion 110 of the guide wire 10 is in fixed contact with the radial wall 22. In some designs, the majority of the circumference of the engaged longitudinal portion 110 that is in fixed contact with the radial wall 22 is at least 70%, and in some designs, it is at least 90%. Guide wire assembly 100 in Figure 1B D This differs from other examples in that the guide wire 10 has a maximum dimension greater than the thickness of the radial wall 22 of the tubular portion 25, and a small angular portion of the guide wire 10 is in contact with the material of the radial wall 22. Guide wire assembly 100 D It also shows that guidewires may have a non-circular cross-section.

[0046] Figure 1C shows exemplary cross-sectional views of guidewire assemblies 100 according to various embodiments in which the distal portion 110 of a fixedly engaged guidewire 10 is externally, or at least largely externally, attached to the radial wall 22 of the tubular portion 25. Attachment can be achieved, for example, by welding, heat welding, soldering, fusing, or bonding the distal portion 110 of the guidewire 10 to the tubular portion 25. Guidewire Assembly 100 E , 100 F , and 100 G The illustrative cross-sectional view shows the range in which the guide wire 10 contacts the tubular portion 25 in such a configuration, i.e., the guide wire assembly 100 E , 100 F As can be seen, this indicates that it is at most an angular minority, and includes cases where it does not directly contact the tubular portion 25, for example, only through an intermediate material 18 such as adhesive or solder. Therefore, the expression "at most an angular minority" means "either an angular minority or no direct contact at all."

[0047] Figure 2A shows a typical guidewire for use with the guidewire assembly 100 of various embodiments disclosed herein, as a second guidewire 20, specifically as a guidewire that the surgeon deploys before using the guidewire assembly 100. The second guidewire 20 includes a proximal end 21 that always remains outside the patient's body. The second guidewire 20 has an outer diameter OD 20 It has the inner diameter ID of the tubular portion 25 of the guide wire assembly 100, as shown in Figure 1A. 25 The outer diameter OD of the second guide wire 20 is 20 It is selected to be at least slightly larger than [the specified value].

[0048] Figure 2B shows additional features of the guidewire assembly 100 shown in Figures 1A and 2B. The tubular section 25 has distal and proximal openings 27, 26. Arrows CL pass through the distal and proximal openings 27, 26. 25 The center line of the tubular portion 25, indicated by arrow CL, is 10 It can be seen that the center line of the first guide wire 10, shown by CL, is parallel to the center line of the tubular portion 25 within a manufacturing tolerance of ±1° or ±2° from parallel. For example, as shown in Figures 2B, 3B, 6A, and 9C, in any embodiment disclosed herein, the center line CL of the tubular portion 25 is parallel to the center line of the first guide wire 10, shown by CL. 25 This is the center line CL of the first guide wire 10. 10 It may be displaced laterally (or equally, radially). In some embodiments, the lateral displacement is the inner diameter ID of the tubular portion. 25 It is at least 5% or at least 10% of the inner diameter ID of the tubular portion 25. In some embodiments, the lateral displacement is the inner diameter ID of the tubular portion 25. 25 It is at least 15% or at least 20% of the inner diameter ID of the tubular portion 25. In some embodiments, the lateral displacement is the inner diameter ID of the tubular portion 25. 25 It is at least 25% or at least 30% of the inner diameter ID of the tubular portion 25. In some embodiments, the lateral displacement is the inner diameter ID of the tubular portion 25. 25 It is at least 35% or at least 40% of the inner diameter ID of the tubular portion 25. In some embodiments, the lateral displacement is the inner diameter ID of the tubular portion 25. 25It is at least 45% or at least 50% of the inner diameter ID of the tubular portion 25. In some embodiments, the lateral displacement is the inner diameter ID of the tubular portion 25. 25 This is over 50%, which can be seen, for example, from the example in Figure 1C.

[0049] Figure 2C shows the second guidewire 20 passing through the tubular section 25 of the guidewire assembly 100. The proximal end 21 of the second guidewire 20 passes through the distal opening 27 of the tubular section 25, and then through the proximal opening 26. Then, as the guidewire assembly slides along the second guidewire 20, the remaining portion of the second guidewire 20 passes through the inner lumen of the tubular section 25. Whether the proximal end 21 of the second guidewire 20 passes through the openings 27, 26 and then through the tubular section 25, or whether the tubular section 25 passes over the proximal end 21, is merely a matter of perspective, and the two actions, or two descriptions, are equivalent. Arrow CL 20 The center line of the second guide wire 20, indicated by arrow CL 10 It can be seen that the first guide wire 10 is parallel to the center line indicated by the first guide wire 10 within a manufacturing tolerance of ±1° or ±2° from parallel to the center line (of the guide wire assembly 100).

[0050] Referring here to Figures 3A-B, 4, 5, and 6A-B, various forms of fixed engagement between the guide wire 10 and the tubular portion 25 of the guide wire assembly 100 are shown.

[0051] Figures 3A and 3B show a partial schematic side view of the guidewire assembly 100, where the engaging portion 110 of the guidewire 10, i.e., the portion fixedly engaged with the tubular portion 25, is thinner than the other portion 120 of the guidewire 10 that is not engaged with the tubular portion 25. In some examples (not shown), the engaging portion 110 is thicker than the other (unengaged) portion 120. As shown in Figure 3A, arrow CL passes through the respective distal and proximal openings 27, 26. 25 The center line of the tubular portion 25, indicated by arrow CL, is 110It can be seen that the first guide wire 10 is parallel to the center line of the engagement portion 110, indicated by the arrow, within a manufacturing tolerance of ±1° or ±2° from parallel to the center line of the (guide wire assembly 100). As shown in Figure 3B, arrow CL passes through the respective distal and proximal openings 27, 26. 25 The center line of the tubular portion 25, indicated by arrow CL, is 10 It can be seen that the first guide wire 10 is parallel to the center line indicated by the first guide wire 10 within a manufacturing tolerance of ±1° or ±2° from parallel to the center line (of the guide wire assembly 100).

[0052] Figure 4, in contrast to, for example, Figures 1A, 2B, and 3A-B, shows a partial schematic side view of the guide wire assembly 100 in which the engaged longitudinal portion 110 of the first guide wire 10 does not include the distal end of the guide wire 10.

[0053] Figure 5 shows a partial schematic side view of the guide wire assembly 100, in which the engaged longitudinal portion 110 of the guide wire 10 is engaged with at least a large portion of the longitudinal direction of the tubular portion 25. In other words, the length of the engaged portion 110 is equal to the length L of the tubular portion 25. 25 It is at least half of that. In contrast, as shown, for example, in Figures 1A, 2B, and 3A-B, the engaged longitudinal portion 110 of the guide wire 10 can engage substantially the entire tubular portion 25, where "substantially" means at least 95%, or at least 97%, or at least 99%.

[0054] Figures 6A and 6B show partial schematic side views of a guidewire assembly 100 in which the engaging portion 110 of the guidewire 10, i.e., the portion fixedly engaged with the tubular portion 25, is thinner than a different portion 120 of the guidewire 10 that is not engaged with the tubular portion 25. In some examples (not shown), the engaging portion 110 is thicker than the different (unengaged) portion 120. The exemplary guidewire assembly 100 in Figures 6A-B is superficially similar to that in Figures 3A-B. In Figures 6A-B, the thicker proximal portion 120 of the first guidewire 10 is positioned so that its central longitudinal axis intersects the inner lumen of the tubular portion 25 at the proximal opening 26, whereas this was not the case in Figures 3A-B. Arrows CL passing through the respective distal and proximal openings 27, 26 are shown as in Figure 6A. 25 The center line of the tubular portion 25, indicated by arrow CL, is 10 It can be seen that the first guidewire 10 is parallel to the center line indicated by the arrow, within a manufacturing tolerance of ±1° or ±2° from parallel to the center line of the guidewire assembly 100. As shown in Figure 6B, arrow CL passes through the respective distal and proximal openings 27, 26. 25 The center line of the tubular portion 25, indicated by arrow CL, is 110 It can be seen that the first guide wire 10 is parallel to the center line of the engagement portion 110, indicated by the first guide wire 10, within a manufacturing tolerance of ±1° or ±2° from parallel to the center line of the engagement portion 110 (of the guide wire assembly 100).

[0055] Referring here to Figures 7A-B and 8A-D, the first guidewire 10 includes a transition section 115 that mediates between the proximal section 120 and the engaged longitudinal section 110. In particular, the transition section adds structural robustness to the joint between the thicker proximal section 120 and the thinner engaging section 110. In the non-limiting example of Figure 7A, the transition section 115 is located proximal to the proximal opening 26 of the tubular section 25. The “slope” of the transition section 115 seen in the side view of Figure 7A is shown as a non-limiting example, and the shape of the transition section 115 is a matter of design choice. Similarly, the footprint of the transition section 115 shown in the top view of Figure 7B represents a specific design choice. In other examples, the three-dimensional shape of the transition section 115 may take into account the forces acting on this portion of the guidewire 10 during deployment.

[0056] The guidewire assembly 100 in Figure 8A is superficially similar to that in Figure 7A. The guidewire assembly 100 in Figure 8A is characterized by the fact that at least a portion of the transition section 115 longitudinally overlaps with the proximal end of the tubular section 25 and lies within the internal lumen of the tubular section 25. In addition, or alternatively, the proximal opening 26 of the tubular section 25 in Figure 8A has a scalloped or notched edge on the opposite side of the position of the first guidewire 10, i.e., in the diametrically opposed position. The shape of the edge is intended, among other things, to facilitate the slidable passage of the tubular section 25 around the second guidewire 20. In embodiments, the guidewire assembly 100 is formed so that the tubular section 25 can slidably pass over the second guidewire 20 having a maximum diameter equal to the maximum diameter of the first guidewire 10. Figure 8B schematically shows an alternative design to the guidewire assembly in Figure 8A. In Figure 8A, the angular majority of the circumference of the engaged longitudinal portion 110 is located outside the tubular portion 25, and / or the engaged longitudinal portion 110 does not penetrate the internal lumen of the tubular portion 25. In Figure 8B, the angular majority of the circumference of the engaged longitudinal portion 110 is located inside the tubular portion 25.

[0057] Figure 8C is, for example, a top view of the guide wire assembly 100 of Figure 8A, and shows a non-limiting example of the shape of the notch at the proximal edge of the tubular portion 25 at the proximal opening 26.

[0058] Figure 8D is a schematic diagram of the proximal end of the second guide wire 20 passing through the tubular section 25 of the guide wire assembly 100 in Figures 8A and 8C. In some embodiments, the second guide wire 20 remains parallel to the first guide wire 10 along the length of the overlap, or may remain parallel to it. In some embodiments, the second guide wire 20 remains parallel to the first guide wire 10 along the length of the overlap, or may remain parallel to it, except for a slight bend at the proximal opening 26 of the tubular section 25.

[0059] Refer here to Figures 9A-D and 9A-D. The guidewire assembly 100 comprises a first guidewire 10 and a tubular section 25. The tubular section 25 is fixedly and non-coaxially engaged with the longitudinal section 110 of the first guidewire 10. The exemplary first guidewire 10 in Figures 9A-D and 9A-D includes an engaged longitudinal section 110 similar to the transition section 115 in Figures 7A-B and 8A-D, but does not include a longitudinal section extending further distally therefrom. As shown in Figure 9B, arrows CL pass through the respective distal and proximal openings 27, 26. 25 The center line of the tubular portion 25, indicated by arrow CL, is 110 It can be seen that the first guide wire 10 is parallel to the center line of the engagement portion 110, indicated by the arrow, within a manufacturing tolerance of ±1° or ±2° from parallel to the center line of the (guide wire assembly 100). As shown in Figure 9C, arrow CL passes through the respective distal and proximal openings 27, 26. 25 The center line of the tubular portion 25, indicated by arrow CL, is 10 It can be seen that the first guidewire 10 is parallel to the center line indicated by the arrow, within a manufacturing tolerance of ±1° or ±2° from parallel to the center line of the guidewire assembly 100. As shown in Figure 6B, arrow CL passes through the respective distal and proximal openings 27, 26. 25 The center line of the tubular portion 25, indicated by arrow CL, is 110 It can be seen that the first guide wire 10 is parallel to the center line of the engagement portion 110, indicated by the first guide wire 10, within a manufacturing tolerance of ±1° or ±2° from parallel to the center line of the engagement portion 110 (of the guide wire assembly 100).

[0060] As can be seen from Figure 10, the guide wire assembly 100 is formed so that the tubular portion 25 can slide over the second guide wire 20. The second guide wire 20 is not shown in the schematic diagram of Figure 10, but the guide wire assembly 100 is formed so that the tubular portion 25 can slide over the second guide wire 20, which has a maximum diameter equal to the maximum diameter of the first guide wire 10.

[0061] Referring here to Figure 11, a method of using multiple guidewires is disclosed using one of the guidewire assemblies 100 disclosed herein and / or shown in Figures 1A, 2B, 3-6, 7A-B, 8A-8B, 8D, 9B-D and 10. For example, using multiple guidewires may involve connecting a first guidewire 10 to a pre-introduced second guidewire 20 during a medical procedure.

[0062] As shown in the flowchart of Figure 11, the method includes at least four method steps S01, S02, S03, and S04.

[0063] Step S01 includes providing a medical system 100 according to any one of the embodiments disclosed herein and / or shown in Figures 1A, 2B, 3-6B, 7A-B, 8A-8B, 8D, 9B-D and 10.

[0064] Step S02 includes locating the proximal end 21 of the pre-installed guidewire 20.

[0065] Step S03 includes the step of sliding the tubular portion 25 of the medical system 100 over the proximal end 21 of a pre-introduced guidewire 20. The proximal end 21 enters the distal opening 27 of the tubular portion 25 and exits the proximal opening 26.

[0066] Step S04 includes advancing the medical system 100 distally on a pre-installed guidewire 20.

[0067] In some embodiments, the execution of step S04 is optional.

[0068] Referring here to Figure 12, a method for using multiple guidewires with a medical system 100 is disclosed. For example, the step of using multiple guidewires may include connecting a first guidewire 10 to a pre-introduced second guidewire 20 during a medical procedure.

[0069] As shown in the flowchart of Figure 12, this method includes at least four method steps S11, S12, S13, and S14.

[0070] Step S01 includes providing a medical system 100 comprising an auxiliary guide wire 10 and a single-lumen tubular portion 25 having a radial wall 22 fixedly and non-coaxially engaged with the longitudinal portion 110 of the auxiliary guide wire 10.

[0071] Step S12 includes locating the proximal end 21 of the second guidewire 20.

[0072] Step S13 includes sliding the tubular portion 25 of the guidewire assembly 100 over the proximal end 21 of the pre-introduced guidewire 20. The proximal end 21 enters the distal opening 27 of the tubular portion and exits the proximal opening 26.

[0073] Step S14 includes advancing the medical system 100 distally on a pre-installed guidewire 20.

[0074] In some embodiments, the execution of step S14 is optional.

[0075] Referring here to Figures 13A-13D, several methods for connecting a first guidewire to a pre-introduced second guidewire during a medical procedure are shown.

[0076] In the first method step, a guidewire assembly 100 according to any embodiment disclosed herein is provided, which comprises a tubular portion 25 according to any embodiment disclosed herein and a first guidewire 10 fixedly engaged with the tubular portion 25. Figure 13A shows a surgeon 5 holding the proximal end 21 of a “second” guidewire 20 that has been pre-introduced into the lumen of patient 2. The surgeon 5 is also holding the first guidewire 10 of the provided device 100.

[0077] The second method step is shown in Figure 13B, in which the surgeon 5 slides the proximal end 21 of the second guidewire 20 through the tubular section 25 of the guidewire assembly 100 along a straight path between the respective distal and proximal openings 27, 26 of the tubular section 25. The straight path has a length-to-diameter ratio of at least 5:1 or at least 10:1.

[0078] Figures 13C and 13D show additional method steps that are optional in some embodiments. In Figure 13C, surgeon 5 is shown sliding the tubular portion 25 of the guidewire assembly 100 distally along the second guidewire 20 in preparation for advancing the first guidewire 10 into the lumen or blood vessel of patient 2. Figure 13D shows surgeon 5 holding the proximal ends of the first and second guidewires 10, 20, respectively, which have been introduced into the lumen or blood vessel of patient 2, with the “first” guidewire 10 being introduced using the function of the guidewire assembly 100 and the relevant methods disclosed in the embodiments.

[0079] Concept of Invention

[0080] Any of the disclosed embodiments may, in particular, include any of the following inventive concepts, numbered 1 to 29 for convenience. One or more of these inventive concepts may be combined with other embodiments of this disclosure within the scope of the present invention.

[0081] Concept of the Invention 1. A guide wire assembly comprising (a) a first guide wire for use in a medical procedure, and (b) a tubular portion fixedly engaged with the longitudinal portion of the first guide wire such that the engaged longitudinal portion of the first guide wire is parallel to the central longitudinal axis of the tubular portion, wherein the guide wire assembly is formed so that the tubular portion can slide around a second guide wire.

[0082] Concept of the Invention 2. A guide wire assembly according to Concept of the Invention 1, wherein the engaged longitudinal portion of the first guide wire is at least partially embedded in the radial wall of the tubular portion in the longitudinal direction.

[0083] Concept of the Invention 3. A guide wire assembly according to Concept of the Invention 2, wherein the engaged longitudinal portion of the first guide wire has a diameter smaller than the thickness of the radial wall.

[0084] Concept of the Invention 4. A guide wire assembly according to any one of the above-described concepts of the Invention, wherein a tubular portion is formed and / or extruded such that the longitudinal portion of a first guide wire is at least partially embedded in a radial wall.

[0085] Concept of the Invention 5. A guidewire assembly according to any one of the above-described concepts of the invention, wherein the radial walls comprise a thermosetting polymer.

[0086] Concept 6 of the Invention. A guide wire assembly according to any one of Concepts 2 to 5 of the Invention, wherein the angular majority of the circumference of the longitudinal portion is in fixed contact with the radial wall.

[0087] Concept 7 of the Invention. A guide wire assembly according to any one of Concepts 2 to 6 of the Invention, wherein at least 70% of the circumference of the engaged longitudinal portion is in fixed contact with the radial wall.

[0088] Concept 8 of the Invention. A guide wire assembly according to any one of Concepts 2 to 7 of the Invention, wherein at least 90% of the circumference of the engaged longitudinal portion is in fixed contact with the radial wall.

[0089] Concept 9 of the Invention. The guide wire assembly according to Concept 1 of the Invention, wherein the engaged longitudinal portion of the first guide wire is joined to the radial wall of the tubular portion by at least one of welding, soldering, fusion, and thermal welding such that the engaged longitudinal portion of the first guide wire is in fixed contact with the radial wall only for a small angular portion of the circumference of the longitudinal portion.

[0090] Concept of the Invention 10. A guide wire assembly according to any one of the above-described concepts of the Invention, wherein the engaged longitudinal portion of the first guide wire has a diameter smaller than the diameter of a different portion of the first guide wire that is not engaged with the tubular portion.

[0091] Concept of the Invention 11. A guide wire assembly according to any one of the above-described concepts of the Invention, wherein the engaged longitudinal portion of the first guide wire includes the distal end of the first guide wire.

[0092] Concept of the Invention 12. A guide wire assembly according to any one of the above-described concepts of the Invention, wherein the engaged longitudinal portion of the first guide wire is engaged with at least a large portion of the longitudinal direction of the tubular portion.

[0093] Concept 13 of the Invention. The guide wire assembly according to Concept 12 of the Invention, wherein the engaged longitudinal portion of the first guide wire is engaged with substantially the entire tubular portion.

[0094] Concept of the Invention 14. A guide wire assembly according to any one of the above-described concepts of the invention, wherein the engaged longitudinal portion of the first guide wire is not nondestructively separable from the tubular portion.

[0095] Concept of the Invention 15. A method for using multiple guide wires, comprising: (a) providing a guide wire assembly as described in any one of the Concepts of the Invention described above; (b) locating the proximal end of a second guide wire; (c) sliding the tubular portion of the guide wire assembly over the proximal end of the second guide wire such that the proximal end enters into the distal opening of the tubular portion and exits from the proximal opening; and (d) advancing the guide wire assembly distally over the second guide wire such that the first guide wire is substantially parallel to the second guide wire.

[0096] Concept of the Invention 16. A method for using multiple guide wires, comprising: (a) providing a guide wire assembly comprising a first guide wire and a tubular portion fixedly engaged with the longitudinal portion of the first guide wire such that the engaged longitudinal portion of the first guide wire is parallel to the central longitudinal axis of the tubular portion; (b) locating the proximal end of a second guide wire; (c) sliding the tubular portion of the guide wire assembly over the proximal end of the second guide wire such that the proximal end enters and exits the distal opening of the tubular portion; and (d) advancing the guide wire assembly distally on the second guide wire such that the first guide wire is substantially parallel to the second guide wire.

[0097] Concept 17 of the Invention. The method according to Concept 16, wherein the engaged longitudinal portion of the first guidewire is at least partially embedded in the radial wall of the tubular portion in the longitudinal direction.

[0098] Concept 18 of the Invention. The method according to Concept 17, wherein the engaged longitudinal portion of the first guide wire has a diameter smaller than the thickness of the radial wall.

[0099] Concept 19 of the Invention. A method according to any one of Concepts 16 to 18 of the Invention, wherein a tubular portion is formed and / or extruded such that the longitudinal portion of a first guidewire is at least partially embedded in the radial wall.

[0100] Concept 20 of the Invention. The method according to any one of Concepts 16 to 19 of the Invention, wherein the radial walls comprise a thermosetting polymer.

[0101] Concept 21 of the Invention. The method according to any one of Concepts 17 to 20 of the Invention, wherein the angular majority of the circumference of the longitudinal portion is in fixed contact with the radial wall.

[0102] Concept 22 of the Invention. The method according to any one of Concepts 17 to 21 of the Invention, wherein at least 70% of the circumference of the engaged longitudinal portion is in fixed contact with the radial wall.

[0103] Concept 23 of the Invention. The method according to any one of Concepts 17 to 22 of the Invention, wherein at least 90% of the circumference of the engaged longitudinal portion is in fixed contact with the radial wall.

[0104] Concept 24 of the Invention. The method according to Concept 16 of the Invention, wherein the engaged longitudinal portion of the first guidewire is joined to the radial wall of the tubular portion by at least one of welding, soldering, fusion, and thermal welding such that the engaged longitudinal portion of the first guidewire is in fixed contact with the radial wall only for a small angular portion of the circumference of the longitudinal portion.

[0105] Concept 25 of the Invention. The method according to any one of Concepts 16 to 24 of the Invention, wherein the engaged longitudinal portion of the first guidewire has a smaller diameter than the diameter of a different portion of the first guidewire that is not engaged with the tubular portion.

[0106] Concept 26 of the Invention. The method according to any one of Concepts 16 to 25 of the Invention, wherein the engaged longitudinal portion of the first guidewire includes the distal end of the first guidewire.

[0107] Concept 27 of the Invention. A method according to any one of Concepts 16 to 26 of the Invention, wherein the engaged longitudinal portion of the first guidewire is engaged with at least a large portion of the longitudinal direction of the tubular portion.

[0108] Concept of the Invention 28. The method of Concept of the Invention 27, wherein the engaged longitudinal portion of the first guidewire is engaged with substantially the entire tubular portion.

[0109] Concept 29 of the Invention. The method according to any one of Concepts 16 to 28 of the Invention, wherein the engaged longitudinal portion of the first guidewire is not nondestructively separable from the tubular portion.

[0110] Those skilled in the art will understand that the present invention is not limited to what is specifically shown and described herein. Rather, the scope of the present invention includes both combinations and partial combinations of the various features described herein, as well as variations and modifications thereof that are not in the prior art and that would be conceivable to those skilled in the art who have read the foregoing description.

Claims

1. A medical system for connecting to a guidewire that has been pre-introduced during an internal procedure, a. Auxiliary guide wire and b. A single-lumen tubular portion having a radial wall fixedly engaged with the longitudinal portion of the auxiliary guide wire, wherein the radial wall defines a passage having dimensions such that the pre-introduced guide wire can slide through it, A medical system in which the tubular portion and the engaged longitudinal portion of the auxiliary guide wire are not coaxially engaged.

2. The medical system according to claim 1, wherein the tubular portion and the auxiliary guide wire are not coaxial.

3. The medical system according to claim 1 or claim 2, wherein the central longitudinal axis of the auxiliary guide wire is parallel to the central longitudinal axis of the tubular portion.

4. The medical system according to any one of claims 1 to 3, wherein the central longitudinal axis of the auxiliary guide wire is displaced laterally from the central longitudinal axis of the tubular portion.

5. The medical system according to any one of claims 1 to 4, wherein the central longitudinal axis of the engaged longitudinal portion of the auxiliary guide wire is parallel to the central longitudinal axis of the tubular portion and is displaced laterally from the central longitudinal axis of the tubular portion.

6. The medical system according to any one of claims 1 to 5, wherein the engaged longitudinal portion of the auxiliary guide wire is at least partially embedded in the radial wall of the tubular portion in the longitudinal direction.

7. The medical system according to any one of claims 1 to 6, wherein the fixed engagement between the tubular portion and the longitudinal portion includes at least one of molding, overmolding, extrusion, welding, heat welding, bonding, soldering, and fusion.

8. The medical system according to any one of claims 1 to 7, wherein the tubular portion is molded and / or extruded such that the longitudinal portion of the auxiliary guide wire is at least partially embedded in the radial wall.

9. The medical system according to any one of claims 1 to 8, wherein the angular majority of the circumference of the engaged longitudinal portion is in fixed contact with the radial wall.

10. The medical system according to any one of claims 1 to 9, wherein a small angular portion of the circumference of the engaged longitudinal portion is in fixed contact with the radial wall.

11. The medical system according to any one of claims 1 to 10, wherein the engaged longitudinal portion of the auxiliary guide wire includes the distal end of the auxiliary guide wire.

12. The medical system according to any one of claims 1 to 11, wherein the engaged longitudinal portion of the auxiliary guide wire is not non-destructively separable from the tubular portion.

13. A method using multiple guide wires, A step of providing a medical system according to any one of claims 1 to 12, The steps include: locating the proximal end of the previously introduced guide wire, The step of slidably passing the tubular portion of the medical system over the proximal end of the pre-introduced guidewire such that the proximal end enters the distal opening of the tubular portion and exits the proximal opening, The steps include: advancing the medical system distally on the pre-installed guide wire; A method that includes [a certain feature].

14. A method of connecting to a guidewire that has been introduced in advance during an internal procedure, A medical system comprising: an auxiliary guide wire; and a single-lumen tubular portion having a radial wall fixedly and non-coaxially engaged with the longitudinal portion of the auxiliary guide wire; A step of locating the proximal end of a guide wire that has been introduced in advance, The step of slidably passing the tubular portion of the medical system over the proximal end of the pre-introduced guidewire such that the proximal end enters the distal opening of the tubular portion and exits the proximal opening, The steps include: advancing the medical system distally on the pre-installed guide wire; A method that includes [a certain feature].

15. The method according to claim 14, wherein the tubular portion and the auxiliary guide wire are not coaxial.

16. The method according to claim 14 or claim 15, wherein the central longitudinal axis of the auxiliary guide wire is parallel to the central longitudinal axis of the tubular portion.

17. The method according to any one of claims 14 to 16, wherein the central longitudinal axis of the auxiliary guide wire is displaced laterally from the central longitudinal axis of the tubular portion.

18. The method according to any one of claims 14 to 17, wherein the central longitudinal axis of the engaged longitudinal portion of the auxiliary guide wire is parallel to the central longitudinal axis of the tubular portion and is displaced laterally from the central longitudinal axis of the tubular portion.

19. The method according to any one of claims 14 to 18, wherein the engaged longitudinal portion of the auxiliary guide wire is at least partially embedded in the radial wall of the tubular portion in the longitudinal direction.

20. The method according to any one of claims 14 to 19, wherein the tubular portion is molded and / or extruded such that the longitudinal portion of the auxiliary guide wire is at least partially embedded in the radial wall.

21. The method according to any one of claims 14 to 20, wherein the angular majority of the circumference of the longitudinal portion is in fixed contact with the radial wall.

22. The method according to any one of claims 14 to 21, wherein the engaged longitudinal portion of the auxiliary guide wire includes the distal end of the auxiliary guide wire.

23. The method according to any one of claims 14 to 22, wherein the engaged longitudinal portion of the auxiliary guide wire is not nondestructively separable from the tubular portion.

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