The present disclosure relates generally to medical devices, and more particularly, to multiple guidewire systems.
A wide variety of guidewires have been developed for intravascular use. Intravascular guidewires are commonly used in conjunction with intravascular devices such as catheters to facilitate navigation through the vasculature of a patient. Because the vasculature of a patient may be very tortuous, it is desirable to combine a number of performance features in a guidewire. For example, it is sometimes desirable that the guidewire have a relatively high level of pushability and torqueability, particularly near its proximal end. It is also sometimes desirable that a guidewire be relatively flexible, particularly near its distal end. In some medical procedures, multiple guidewires may be used to facilitate the navigation of multiple catheters, or catheters configured to track over multiple guidewires, through the vasculature of the patient. However, when employing multiple guidewires, in some instances, the guidewires may twist and/or cross during advancement through the vasculature making it more difficult to advance a catheter over one or more of the guidewires. Accordingly, there is a need to provide alternative multiple guidewire systems and assemblies to facilitate the navigation of catheters through the vasculature and, in some instances, reduce guidewire crossing.
The present disclosure relates generally to medical devices, and more particularly, to multiple guidewire systems. In one illustrative embodiment, a guidewire system may include a first guidewire releasably coupled to a second guidewire such when the guidewire system is advanced through a vessel, the first guidewire is coupled to the second guidewire. When the guidewire system is at a desired location in the vessel, the first guidewire and the second guidewire may be separated. In some instances, the first guidewire is releasably coupled to the second guidewire with a chemical bonding agent (e.g. adhesive), a mechanical coupling (e.g. clamp, interlocking features), a magnetic coupling, and/or an electrical coupling. In some embodiments, the first guidewire and the second guidewire may be longitudinally offset when releasably coupled.
In another illustrative embodiment, a medical system may include a first guidewire and a second guidewire that may be configured to be coupled to the first guidewire when the first and second guidewire are initially advanced through a vessel.
The medical system may also include a first medical device configured to be advanced over the first guidewire to at least partially separate the first guidewire and the second guidewire. In some embodiments, the medical system may also include an adhesive or other chemical bonding agent disposed at least partially between the first guidewire and the second guidewire. The adhesive or other chemical bonding agent may be configured to at least partially dissolve in vivo. In some cases, the medical system may also include a second medical device configured to be advanced over to the second guidewire.
In another illustrative embodiment, a method for guiding a plurality of medical devices to a desired location in a vessel is disclosed. The method may include coupling a first guidewire to a second guidewire, advancing the coupled first guidewire and the second guidewire to the desired location in the vessel, and separating at least a portion of the first guidewire from the second guidewire when the first guidewire and the second guidewire are at the desired location in the vessel. In some embodiments, separating at least a portion of the first guidewire from the second guidewire may include advancing a first medical device over the first guidewire to separate the first guidewire from the second guidewire, pulling the first guidewire and second guidewire apart from outside the vessel, and/or dissolving at least a portion of an adhesive bond between the first guidewire and the second guidewire. The method may also include further advancing at least one of the first guidewire and the second guidewire after the first guidewire is separated from the second guidewire.
The preceding summary is provided to facilitate an understanding of some of the innovative features unique to the present disclosure and is not intended to be a full description. A full appreciation of the disclosure can be gained by taking the entire specification, claims, drawings, and abstract as a whole.
The disclosure may be more completely understood in consideration of the following detailed description of various illustrative embodiments of the disclosure in connection with the accompanying drawings, in which:
The following description should be read with reference to the drawings wherein like reference numerals indicate like elements throughout the several views. The detailed description and drawings show several embodiments which are meant to be illustrative of the claimed invention.
In the illustrative embodiment, guidewires 12 and 14 may be releasably coupled, connected, bonded, attached, or otherwise joined together with, for example, a chemical coupling, a mechanical coupling, an electrical coupling, a magnet coupling, and/or any other suitable coupling. As shown in
In some embodiments, guidewires 12 and 14 may be coupled (e.g. bonded) together along an entire length of guidewire 12 and/or 14 (shown in
In some embodiments, guidewires 12 and 14 may be spot welded together at portions 15 with a suitable biodegradable material. For example, guidewires 12 and 14 may be spot welded together with magnesium, which may dissolve when placed in a body vessel for a period of time.
In the illustrative embodiments, guidewires 12 and 14 may be actively and/or passively separated when at a desired location in the vasculature of the patient. For example, guidewires 12 and 14 may be passively separated by allowing the adhesive or other chemical bonding agent to dissolve (or at least partially dissolve) in vivo and/or by expansion of a self-expanding mechanical coupling (e.g. clamp shown in
In another embodiment, the guidewires 12 and 14 may be configured to have a chemical attraction that can be reversed and/or released when flushed with a benign chemical. In some cases, the chemical attraction of guidewires 12 and 14 may be induced via a coating applied to the guidewires 12 and 14. It is contemplated that other manners of creating a chemical attraction, which, in some cases, is reversible and/or removable, between the guidewires 12 and 14 may be employed.
In the illustrative embodiment, guidewires 12 and 14 may include any suitable materials, structure, and dimensions according to the desired characteristics and function of the guidewires 12 and 14. For example, the proximal section 11 and the distal section 13 of guidewires 12 and 14 may have a solid cross-section or may have a hollow cross-section. Additionally, proximal and distal sections 11 and 13 may be formed of any suitable material dependent upon the desired properties of the guidewire. Some examples of suitable materials include metals, metal alloys, and polymers. In some embodiments, the proximal section 11 may be formed of relatively stiff material such as straightened 304v stainless steel wire. Alternatively, proximal section 11 may include a metal or metal alloy such as a nickel-titanium alloy, nickel-chromium alloy, nickel-chromium-iron alloy, cobalt alloy, or other suitable material. In general, the material used to construct proximal section 11 may be selected to be relatively stiff for pushability and torqueability.
In some embodiments, the distal section 13 may be formed of a relatively flexible material such as a straightened super elastic or linear elastic alloy (e.g., nickel-titanium) wire, or alternatively, a polymer material, such as a high performance polymer. Alternatively, distal section 13 may be comprised of a metal or metal alloy such as stainless steel, nickel-chromium alloy, nickel-chromium-iron alloy, cobalt alloy, or other suitable material. In general, the material used to construct distal section 13 may be selected to be relatively flexible for trackability.
In some particular embodiments, the distal section 13 may be a linear elastic nickel-titanium alloy, for example, linear elastic nitinol. Within the family of commercially available nitinol alloys, is a category designated “linear elastic” which, although is similar in chemistry to conventional shape memory and superelastic varieties, exhibits distinct and useful mechanical properties. By skilled applications of cold work, directional stress, and heat treatment, the wire is fabricated in such a way that it does not display a “superelastic plateau” or “flag region” in its stress/strain curve. Instead, as recoverable strain increases, the stress continues to increase in an essentially linear relationship until plastic deformation begins. In some embodiments, the linear elastic nickel-titanium alloy is an alloy that does not show any martensite/austenite phase changes that are detectable by DSC and DMTA analysis over a large temperature range. For example, in some embodiments, there is no martensite/austenite phase changes detectable by DSC and DMTA analysis in the range of about −60° C. to about 120° C. The mechanical bending properties of such material are therefore generally inert to the effect of temperature over this very broad range of temperature. In some particular embodiments, the mechanical properties of the alloy at ambient or room temperature are substantially the same as the mechanical properties at body temperature. In some embodiments, the use of the linear elastic nickel-titanium alloy for the distal portion 16 allows the guidewire to exhibit superior “pushability” around tortuous anatomy.
In some embodiments, the linear elastic nickel-titanium alloy comprises in the range of about 50 to about 60 wt. % nickel, with the remainder being essentially titanium. In some particular embodiments, the composition comprises in the range of about 54 to about 57 wt. % nickel. One example of a suitable nickel-titanium alloy is FHP-NT alloy commercially available from Furukawa Techno Material Co. of Kanagawa, Japan.
In the illustrative embodiment, guidewires 12 and 14 may be configured to have diameters such that one device may be delivered over both guidewires 12 and 14, or in other case, the guidewires 12 and 14 may be configured to have diameters such that a device can be delivered over each guidewires 12 and 14 separately. In some particular embodiments, the proximal section 11 may be formed from a stainless steel wire having a diameter in the range of 0.01 to 0.02 inches, and a length in the range of about 50 to about 110 inches, and the distal section 13 may be formed from a linear elastic nitinol wire having a diameter that ranges from a diameter to match the diameter of the proximal section 11 to as small as about 0.002 inches, and a length in the range of 3 to 15 inches, but this is just one example.
In some embodiments, the proximal section 11 and the distal section 13 may be formed of different materials (i.e., materials having different moduli of elasticity) resulting in a difference in flexibility. For example, the proximal section 11 may be formed of stainless steel wire and the distal section 13 may be formed of nickel-titanium alloy wire, both having the same dimensions, but having a different elastic modulus.
In the illustrative embodiment, guidewires 12 and 14 may include other features typically found in guidewires, such as, for example, one or more tapered and one or more constant diameter regions in the distal tip, a shaping ribbon or wire, and/or radiopaque material, coatings (e.g. lubricious coatings). Some other example coatings and materials and methods used to create such coatings can be found in U.S. Pat. Nos. 6,139,510 and 5,772,609, which are incorporated herein by reference.
In the illustrative embodiment, it is contemplated that guidewires 12 and 14 may include the same or different features and/or materials, as desired. Additionally, while only two guidewire 12 and 14 are shown in
As shown in
In the illustrative embodiment, catheter 18 may be an angioplasty balloon catheter, a stent delivery catheter, and/or any other catheter that is configured to be advanced along a guidewire, as desired. While catheter 18 is shown for merely illustrative purposes, it is not meant to be limiting in any manner. It is contemplated that any suitable medical device may be advanced over guidewire 12 to separate guidewires 12 and 14, as desired.
In the illustrative embodiment, catheter 20 may be an angioplasty balloon catheter, a stent delivery catheter, and/or any other catheter or medical device that is configured to be advanced along a guidewire, as desired.
While
As shown in
In some embodiments, the clamps 42 may be configured to expand when heated to human body temperature or, in other words, the one or more clamps 42 may include a self-expanding and/or temperature sensitive material One example self-expanding material that may be used is Nitinol, however, other self-expanding and/or temperature sensitive materials may be used, as desired. With such a configuration, the clamps 42 may be configured couple guidewires 12 and 14 together when being advanced through the vasculature of a patient and, once at a desired location in the vasculature, the clamps 42 may radially expand allowing guidewires 12 and 14 to be separated, as shown in
As shown in
In other embodiments, clamps 42 may be configured to dissolve when positioned in a body vessel for a period of time. One example material that may be used for such clamps is magnesium. However, other suitable materials may be used.
Furthermore, piezoelectric structure 50 shown in
In the illustrative embodiment, relative movement of guidewires 12 and 14 may cause protrusions 54 and 56 to engage and disengage, as desired. For example, applying a force to guidewire 12 in a relative right-to-left direction (as shown) may cause protrusion 54 to engage protrusion 56 whereas applying a force on guidewire 12 in the opposite direction (left-to-right as shown) may cause protrusion 54 to disengage protrusion 56 allowing guidewires 12 and 14 to separate.
While protrusions 54 and 56 are shown, these are just one example. It is contemplated that any suitable protrusions, recesses, and/or combination of protrusions and recesses may be used to create a mechanical coupling or an interlocking structure for releasably coupling guidewires 12 and 14.
In the illustrative embodiment, guidewires 12 and 14 may be advanced through the vasculature of the patient in a connected configuration. Once at a desired location in the vasculature, the guidewires 12 and 14 may be separated by either advancing a device (e.g. catheter) over one or both of guidewires 12 and 14 or pulling apart guidewires 12 and 14. However, other suitable methods may be used to separate Velcro 70, as desired.
Having thus described many embodiments of the present disclosure, those of skill in the art will readily appreciate that yet other embodiments may be made and used within the scope of the claims hereto attached. Numerous advantages of the disclosure covered by this document have been set forth in the foregoing description. It will be understood, however, that this disclosure is, in many respect, only illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of parts without exceeding the scope of the disclosure. The invention's scope is, of course, defined in the language in which the appended claims are expressed.
This application claims the benefit U.S. Provisional Application No. 61/452,957, filed Mar. 15, 2011, the disclosure of which is incorporated herein in its entirety.
Number | Date | Country | |
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61452957 | Mar 2011 | US |