WO2007089893A1

WO2007089893A1 - Wire guide having distal coupling tip

Info

Publication number: WO2007089893A1
Application number: PCT/US2007/002743
Authority: WO
Inventors: Jeffry S. Melsheimer
Original assignee: Cook Incorporated
Priority date: 2006-01-31
Filing date: 2007-01-31
Publication date: 2007-08-09
Also published as: US7785275B2; US20070185416A1

Abstract

A coupling wire guide is structured to be slidably coupled to a previously introduced wire guide, and is also well suited for stand-alone use. The coupling wire guide generally includes a main body having a distal end and a coupling tip connection to the distal end. The coupling tip includes a coupling portion and a tip portion. The coupling portion defines a coupling passageway having a proximal port and distal port for receiving a previously introduced wire guide. The tip portion includes a distal end surface having an atraumatic shape.

Description

WIRE GUIDE HAVING DISTAL COUPLING TIP

Description

Cross-Reference to Related Application

[0001] This application claims the benefit of U.S. Provisional Application Serial

No. 60/763,51 1 filed on January 31 , 2006, entitled "WIRE GUIDE HAVING DISTAL COUPLING TIP", the entire contents of which are incorporated herein by reference. Technical Field

[0002] This invention relates generally to a wire guide for use in intracorporeal procedures, and more particularly relates to the construction of a wire guide to be coupled to a previously introduced wire guide for assistance during interventional procedures in vessels with proximal tortuosity, or as a more substantial wire guide for angioplasty procedures, stenting procedures, and other device placement procedures and their related devices.

Background of the Invention

[0003] Proximal tortuosity of the vasculature is problematic for all medical catheter devices such as atherectomy devices, angioplasty devices, stent delivery devices, and filter delivery devices. Wire guides are therefore typically used to navigate the vasculature of a patient during percutaneous interventional procedures. Once the wire guide has been introduced, it may then be used to introduce one or more medical catheter devices. Thus, most wire guides are typically 0.014 inches in diameter and have a lubricious coating to enhance wire guide introduction movement. Conventional 0.014 inch floppy wire guides must have sufficient flexibility and torque control for navigation through tortuous vessels. At the same time, the wire guide must have a certain amount of rigidity to pass through lesions, straighten extremely tortuous vessels, and support medical catheter devices that are introduced over the wire guide. [0004] Accordingly, wire guides are subjected to potentially conflicting requirements. Conventional 0.014 inch floppy wire guides are usually sufficient for navigation of moderately tortuous vessels. However, in some situations the wire guide tip may prolapse away from the site to which it is guiding the device. For example, balloon angioplasty in vessels with proximal tortuosity has been associated with a higher incidence of acute complications and procedural failure due to the inability to cross lesions with a conventional floppy wire guide, and due to the inability of the wire guide to provide adequate support to the balloon catheter. Heavy-duty wire guides, on the other hand, are generally not well suited as primary wire guides because of their stiffness and potential for causing injury to the vessel during introduction. [0005] It may therefore be desirable to use conventional floppy wire guides for navigation of tortuous vessels, and then enhance the conventional wire guide with a supplemental wire guide. The supplemental wire guide will straighten out the vessel curves and ease further wire guide movement. Additionally, the supplemental wire guide provides greater support and enhances the tracking of balloons, stents, stent delivery devices, atherectomy devices, and other medical catheter devices as compared to a conventional floppy wire guide. This technique is commonly referred to as the "Buddy Wire" technique, details of which are disclosed in U.S. Patent Application Serial No. 1 1 /081 , 146, filed March 16, 2005. [0006] However, the navigation of the supplemental wire guide parallel to the first wire guide is an exacting and time consuming process in which additional difficulties are encountered. For example, the second wire guide can cork screw or coil around the first wire guide, which may result in immobilization or unintended movement of the first wire guide, which in turn may require the retraction and re- feeding of the supplemental wire guide and/or the primary wire guide. Moreover, if retraction of the supplemental wire guide is necessary, either of the wire guides may become contaminated and the entire process may need to be restarted with sterile components. The time consumed by this process can be critical to the success of the procedure. Additionally, when traversing through the heart of a patient, and particularly the ostium, the larger open space of the heart makes identical placement of the supplemental wire guide somewhat difficult.

[0007] Accordingly, there exists a need to provide a supporting wire guide for intracorporeal procedures that may be easily and reliably traversed to a position proximate a previously introduced wire guide.

Summary of the Invention [0008] The present invention provides a supporting wire guide for percutaneous interventional procedures that may be easily and reliably traversed to a position proximate a previously introduced wire guide, as well as be used as a stand-alone wire guide. The supporting wire guide is a coupling wire guide that is structured to be slidably coupled to the previously introduced wire guide. In one embodiment constructed in accordance with the teachings of the present invention, the coupling wire guide generally includes a main body having a distal end and a coupling tip connected to the distal end. The coupling tip includes a coupling portion and a tip portion. The tip portion includes a distal end surface having an atraumatic shape. The coupling portion defines a coupling passageway having a proximal port and distal port. Both the proximal and distal ports open radially. In this manner, the coupling wire guide is well suited for use as a stand-alone wire guide, as well as being capable of being coupled to a previously introduced wire guide.

[0009] According to more detailed aspects of the invention, the coupling tip is coaxial with the main body and preferably has an outer diameter about equal to or less than an outer diameter of the main body. These features permit the coupling wire guide to be withdrawn proximally through a catheter or other device which is placed over the coupling wire guide. The proximal and distal ports may be circumferentially aligned or non-aligned. When not aligned, the proximal and distal ports preferably open radially in opposite directions. The proximal and distal ports preferably span an axial distance greater than about three times the diameter of the previously introduced wire guide. The coupling wire guide may further include intermediate and distal end caps adjacent the proximal and distal ports, respectively, which define a guiding surface structured to guide the previously introduced wire guide relative to the respective port. [0010] According to additional detailed aspects of the invention, the coupling wire guide may further include means for directly attaching the coupling portion to the previously introduced wire guide at a point between the ends of the previously introduced wire guide. Accordingly, the coupling wire guide may be "clipped-on" to the mid-section of the previously introduced wire guide or at any location having the most efficacy. This attachment function may include constructing the coupling portion of a resilient material having a slot extending from the proximal port to the distal port. Alternatively, the attachment means may include forming the coupling portion as a helically wound strip. Brief Description of the Drawing

[0011] The accompanying drawings incorporated in and forming a part of the specification illustrate several aspects of the present invention, and together with the description serve to explain the principles of the invention. In the drawings: [0012] FIG. 1 is a top view of a coupling wire guide constructed in accordance with the teachings of the present invention;

[0013] FIG. 2 is a cross-sectional view of the coupling wire guide depicted in

FIG. 1 ;

10014] FlG. 3 is a top view of another embodiment of a coupling wire guide constructed in accordance with the teachings of the present invention;

[0015] FIG. 4 is a cross-sectional view of the coupling wire guide depicted in

FIG. 3;

[0016] FIG. 5 is a top view of another embodiment of a coupling wire constructed in accordance with the teachings of the present invention; [0017] FIG. 6 is a side view of the coupling wire guide depicted in FIG. 5;

[0018] FIG. 7 is a top view of another embodiment of a coupling wire guide constructed in accordance with the teachings of the present invention;

[0019] FIG. 8 is a side view of the coupling wire guide depicted in FIG. 7;

[0020] FIG. 9 is a top view of another embodiment of a coupling wire guide constructed In accordance with the teachings of the present invention; and

[0021] FIG. 10 is a cross-sectional view of the coupling wire guide depicted in

FIG. 9.

Detai led Description [0022] Turning now to the figures, FIGS. 1 and 2 depict a coupling wire guide

20 constructed in accordance with the teachings of the present invention. The coupling wire guide 20 is easily and reliably coupled to and traversed along a previously introduced wire guide 10 (FIG. 2), and notably is well suited for serving as a standard wire guide when not coupled to the previously introduced wire guide 10.

Specifically, the distal end includes an atraumatic configuration facilitating stand-alone use, while the coupling wire guide 20 maintains the ability to be withdrawn proximally through a device placed over it, such as catheter devices, angioplasty devices, stenting devices, embolic protection devices, filtering devices, biopsy devices, cooling/aspiration devices and many other medical devices which may be tracked over a wire guide.

While wire guides are generally used in percutaneous interventional procedures, it will be recognized by those skilled in the art that the wire guide 20 of the present invention may also be employed non-percutaneously, such as in endoscopic or other intracorporeal procedures. [0023] The coupling wire guide 20 generally includes a main body 22 having a coiled wire 24 disposed over a mandrel 26, a structure well known in the art. An end cap 28 forms the distal end of the main body 22, and includes a guiding surface 29 structured to guide the previously introduced wire guide 10 relative to the coupling tip 30. It will be recognized that the main body 22 of the coupling wire guide 20, as well as the previously introduced wire guide 10, may take numerous forms as many types of wire guides are known in the art, including solid wire, tubular wires, coiled wires and combinations thereof. For example, U.S. Patent No. 5,243,996 discloses an exemplary solid wire mandrel having a coiled tip section, the disclosure of which is hereby incorporated by reference in its entirety.

[0024] Preferably, the coupling tip 30 is constructed of a resilient material such as nitinol (nickel-titanium superelastic alloy) or stainless steel, although any biocompatible resilient material may be employed including thermoplastics and other metals or alloys. The coupling tip 30 may be formed by laser cutting or otherwise removing material from a tubular cannula. As such, the main body 22 could be unitarily formed with the coupling tip 30 and the main body 22 could simply comprise the tubular structure of the coupling tip 30 extended proximally. Such a tubular body 22 could further include slots or notches which improve the flexibility of the tubular cannula.

[0025] The coupling tip 30 includes an attachment portion 32, a coupling portion

34, and a tip portion 36. The coupling tip 30 is generally formed out of a tubular structure 38, and preferably by laser cutting a cannula as noted above. The use of a tubular structure 38 provides the coupling tip 30 with sufficient axial rigidity and radial flexibility for navigation of the vasculature either attached to the previously introduced wire guide 10 or as an individual wire guide 20.

[0026] As best seen in FIG. 2, the coupling tip 30 is preferably attached to the distal end of main body 22 by soldering or welding the tubular attachment portion 32 of the coupling tip 30 to the intermediate end cap 28 of the main body 22 (and to the outer wire 24). As the main body 22 and the coupling tip 30 may be constructed of numerous types of materials, it will be recognized that numerous types of attachment structures or methods may be employed such as adhesives, fasteners, material deformation, latches, plastic welding techniques and the like. The outer diameter of the coupling tip 30, and at least the attachment portion 32, is about equal to or less than a diameter of the main body 22. Due to the similarly sized outer diameters, the coupling wire guide 20 may be proximally withdrawn from any device which is placed over the wire guide 20, further enhancing the stand-alone use of the coupling wire guide 20. As a result, the coupling tip 30 will have an outer diameter greater than the outer diameter of the previously introduced wire guide 10, and an inside diameter compatible with the outer diameter of the previously introduced wire guide 10. [0027] The coupling portion 34 defines a coupling passageway 40 having a proximal port 42 and a distal port 44 through which the previously introduced wire guide 10 passes during the Buddy Wire or related techniques. The proximal and distal ports 42, 44 are radially facing openings (i.e. open radially) to provide access to the coupling passageway 40 while maintaining the outer diameter of the coupling tip 30. As such, the outer diameter of the coupling wire guide 20, and specifically the coupling tip 30, is greater than the previously introduced wire guide 10 to which it will be slideably coupled. In the embodiment depicted in FIG. 1 and 2, the proximal and distal ports 42, 44 face in radially opposite directions, i.e., they are circumferentially spaced by about 180 degrees. Preferably the proximal and distal ports 42, 44 span an axial distance of about three times the outer diameter of the previously introduced wire guide 10 or more to facilitate a smooth transition of the wire guide 10 into the coupling passageway 40.

[0028] To further enhance the ability of the coupling wire guide 20 to serve as an individual wire guide when decoupled from the previously introduced wire guide 10, the tip portion 36 includes a distal end cap 46 defining an exposed distal end surface 48. The distal end cap 46 and its end surface 48 are structured atraumatically, and preferably as a spherical ball shape to assist in placement of the wire guide 20 and prevent damage to the vasculature. This feature of the coupling tip 30, in combination with the tubular structure 38 providing axial rigidity and radial flexibility, as well as the similarly sized outer diameters, makes the coupling wire guide 20 well suited for standalone use and coupling to a previously introduced wire guide 10. The distal end cap 46, as well as the intermediate end cap 28, are preferably formed from a solder material such as metal alloys (e.g. Tin-Silver-Copper), although many other materials, including thermoplastics, may readily be employed to form the end caps, which are then connected to the main body 22 and the coupling tip 30 through any of the methods described above.

[0029] It will be recognized by those skilled in the art that the proximal and distal ports 42, 44 may take many different configurations and relative positioning. For example, FIGS. 3 and 4 depict another embodiment of a coupling wire guide 120 having differently arranged proximal and distal ports 142, 144, in accordance with the teachings of the present invention. Similar to the previous embodiment, the coupling wire guide 120 includes a main body 122 having an outer wire 124 disposed over an inner mandrel 126 and secured at their distal end by an intermediate end cap 128. The intermediate end cap 128 defines a guiding surface 129 structured to guide the previously introduced guide wire 10 relative to the proximal port 144. A coupling tip 130 generally includes an attachment portion 132, a coupling portion 134 and a tip portion 136. The coupling tip 130 is constructed of a tubular member 138, and the coupliπg portion 134 defines a coupling passageway 140 having proximal port 142 and distal port 144 sized to receive a previously introduced wire guide 1 10 therein. [0030] The coupling wire guide 1 20 and its coupling tip 130 are again provided with a distal end cap 146 defining an atraumatic end surface 148. It will also be noted that in this embodiment, the proximal port 142 and the distal port 144 are facing in the same radial direction. That is, the proximal and distal ports 142, 144 are circumf erentially aligned, whereby the previously introduced wire guide 1 10 enters and exits the coupling tip 130 from the same side of the coupling wire guide 120. As noted above, the relative orientation of the proximal and distal ports 142, 144 may take many configurations, and FIGS. 1 -4 merely depict two preferred configurations.

[0031] Turning now to FIGS. 5 and 6, depicted is another embodiment of a coupling wire guide 220 constructed in accordance with the teachings of the present invention. The coupling wire guide 220 is "side-loading", meaning the wire guide 220 may be attached by "cl»pρing-on" to a mid-section of the previously introduced wire guide 10. As used herein, the term "mid-section" refers to any point between the free ends of the previously introduced wire guide. In this manner, the coupling wire guide 220 may be coupled to and traversed along the previously introduced wire guide 210 without gaining access to the proximal or distal end of the previously introduced wire guide 210, further increasing the versatility thereof. [0032] As with the previous embodiments, the coupling wire guide 220 generally includes a main body 222 formed of an outer wire 224 disposed over an inner mandrel 226 which are linked at their distal ends by an intermediate end cap 228 defining a guide surface 229. A coupling tip 230 is connected to a distal end of the main body 222 and generally includes an attachment portion 232, a coupling portion 234 and a tip portion 236. The tip portion 236 again includes a distal end cap 246 defining a distal end surface 248 which is designed to be atraumatic. The coupling portion 234 defines an internal coupling passageway 240 having a proximal port 242 and a distal port 244 sized to receive the previously introduced wire guide 210. The distal end cap 246 defines a guide surface 249 for guiding the previously introduced wire guide 210 relative to the proximal port 244. [0033] Unlike the prior embodiments, the coupling tip 230 includes a generally tubular member 238 having a helical slot 243 formed therein which is in communication with the coupling passageway 240. Further, the slot 243 extends from the proximal port 242 to the distal port 244, thereby providing the "side-loading" function to the coupling wire guide 220. That is, the previously introduced wire guide 210 may simply be pressed through the slot 243, which expands in size due to the resilient but flexible nature of the coupling tip 230. Alternatively, the coupling portion

234 may be thought of as a helically wound strip of material 238, which can be at least partially unwound and then rewound around the previously introduced wire guide 210. [0034] It will be recognized by those skilled in the art that the structure of the slot 243 extending between the proximal and distal ports 242, 244 can take many forms, as can the coupling portion 234, in order to provide "side-loading" of the coupling tip 230. For example, while the slot 243 has been shown generally smaller than a diameter of the previously introduced wire guide 210, the slot 243 may have a larger width and utilize features such as retaining tabs projecting into the area of the slot. Still further, the slot 243 may be linear (i.e. generally parallel to a central axis of . the coupling tip 230) or curved, or helical as shown. Further details regarding various structures providing side-loading to a coupling tip having proximal and distal ports may be found in commonly assigned and copending U.S. Patent Application No.

60/763,523, the disclosure of which is hereby incorporated by reference in its entirety. [0035] FIG. 7 and 8 depict yet another embodiment of a coupling wire guide 320 constructed, in accordance with the teachings of the present invention. As with the previously embodiments, the coupling wire guide 320 generally includes a main body 322 formed of an outer wire 324 disposed over an inner mandrel 326 and linked at their distal end by an intermediate end cap 328 defining a guide surface 329. A coupling tip 330 is connected to a distal end of the main body 322 and generally includes an attachment portion 332, a coupling portion 334 and a tip portion 336. The tip portion 336 again includes a distal end cap 346 defining a distal end surface 348 which is designed to be atraumatic. The distal end cap 346 also defines a guide surface 349 for guiding the previously introduced wire guide 310 relative to the proximal port 344. The coupling portion 334 is constructed of a generally tubular member 338 defining an internal coupling passageway 340 having a proximal port 342 and a distal port 344 sized to receive the previously introduced wire guide 310. A generally helical slot 343 in the coupling portion 334 provides the distal tip 330 with

"side-loading" functionality, as discussed in the prior embodiment. [0036] In the embodiments of FIGS. 5 and 6, the proximal and distal ports 242,

244 face in radially opposite directions. However, in this embodiment (FIGS. 7 and 8), the proximal and distal ports 342, 344 face in the same radial direction. That is, similar to the embodiment depicted in FIGS. 3 and 4, the proximal and distal ports 342, 344 are circumferentially aligned, permitting the previously introduced wire guide 310 to enter and exit the coupling passageway 340 from the same side of the coupling wire guide 320.

[00371 Another embodiment of a coupling wire guide 420 constructed in accordance with the teachings of the present invention has been depicted in FIGS. 9 and 10. As with the previous embodiments, the coupling wire guide 420 includes the main body 422 having an outer wire 424 disposed over an inner mandrel 426 and linked at their distal ends by an intermediate end cap 428 defining a guiding surface 429. A coupling tip 430 generally includes an attachment portion 432, a coupling portion 434 and a tip portion 436. In this embodiment, the attachment portion 432 is formed of a strip of material 438 having a semi-annular cross-section, preferably spanning about 90 degrees. As such, the semi-annular strip 438 is attached to the distal end of the main body 422 by soldering or welding directly to the outer coil 424 and intermediate end cap 428.

[0038] The coupling portion 434 of the coupling tip 430 is constructed of a tubular member defining a coupling passageway 440 having proximal port 442 and a distal port 444 sized to receive the previously introduced wire guide 410. Unlike the prior embodiments, in this embodiment the proximal port 442 is axially facing. More particularly, the semi-annular strip 438 forming the attachment portion 432 extends axially from the distal end of the main body 422 a distance before the coupling portion 434 having a tubular structure. The distal port 444 is constructed similarly to prior embodiments and opens radially. Likewise, the tip portion 436 is constructed similarly to previous embodiments and includes a distal end cap 446 defining a distal end surface 448 that is atraumatic.

[0039] By providing an attachment portion 432 formed as a strip 438, the coupling tip 430 may be connected to an already existing wire guide while only minimally increasing its outer diameter, maintaining the ability to be withdrawn proximally from a device placed over the coupling wire guide 420. A linear slot 443 has also been provided linking the proximal port 442 to the distal port 444, thereby providing a "side-loading" function as previously discussed. Generally, the coupling tip 430 is constructed of a resilient material which flexes to adjust the size of the slot

443 to permit passageway of the previously introduced wire guide 410 therethrough. [0040] The foregoing description of various embodiments of the invention has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise embodiments disclosed. Numerous modifications or variations are possible in light of the above teachings. The embodiments discussed were chosen and described to provide the best illustration of the principles of the invention and its practical application to thereby enable one of ordinary skill in the art to utilize the invention in various embodiments and with various modifications as are suited to the particular use contemplated. All such modifications and variations are within the scope of the invention as determined by the appended claims when interpreted in accordance with the breadth to which they are fairly, legally, and equitably entitled.

Claims

1. A coupling wire guide for coupling to a previously introduced wire guide during intracorporeal procedures, the coupling wire guide comprising: a main body having a distal end; a coupling tip connected to the distal end of the main body, the coupling tip including a coupling portion and a tip portion; the tip portion including a distal end surface; and the coupling portion defining a coupling passageway having a proximal port and a distal port, at least the distal port opening radially.

2. The coupling wire guide of claim 1 , wherein said distal end surface of the tip portion has an atraumatic shape.

3. The coupling wire guide of claim 1 , wherein said distal end surface of the tip portion is closed.

4. The coupling wire guide of claim 1 or claim 2, wherein the proximal and distal ports both opening radially.

5. The coupling wire guide of any one of the preceding claims, wherein the coupling tip has an outer diameter about equal to or less than an outer diameter of the main body.

6. The coupling wire guide of any one of the preceding claims, wherein the coupling tip is co-axial with the main body.

7. The coupling wire guide of any one of the preceding claims, wherein the proximal and distal ports are circumferentially aligned.

8. The coupling wire guide of any one of claims 1 to 6, wherein the proximal and distal ports are circumferentially non-aligned and preferably open radially in radially opposite directions.

9. The coupling wire guide of any one of the preceding claims, wherein the proximal and distal ports each span an axial distance greater than about three times the diameter of the previously introduced wire guide.

10. The coupling wire guide of any one of the preceding claims, wherein the distal end of the main body includes an intermediate end cap, the intermediate end cap defiπing a guiding surface adjacent the proximal port structured to guide the previously introduced wire guide relative to the proximal port.

1 1 . The coupling wire guide of claim 1 , wherein the tip portion includes a distal end cap defining the distal end surface, the distal end cap defining a guiding surface adjacent the distal port structured to guide the previously introduced wire guide relative to the distal port.

12. The coupling wire guide of any one of the preceding claims, further comprising an attachment means for directly attaching the coupling portion to the previously introduced wire guide at a point between the ends of the previously introduced wire guide and retaining the previously introduced wire guide within the coupling passageway during relative translation of the coupling wire guide and previously introduced wire guide.

13. The coupling wire guide of claim 12, wherein the attachment means comprises a slot formed in the coupling portion extending from the proximal port to the distal port, the slot being in communication with the coupling passageway.

14. The coupling wire guide of claim 12, wherein the coupling portion comprises a helically wound strip that is configured to form the attachment means.

15. The coupling wire guide of any one of the preceding claims, wherein the distal port is spaced from the distal end surface.

16. The coupling wire guide of claim 1 , wherein the proximal port is axially opening.

17. The coupling wire guide of claim 16, the coupling tip further including an attachment portion connected to the main body, the attachment portion structured as a semi-annular strip.

18. The coupling wire guide of claim 16 or claim 17, wherein the coupling portion is formed by a tubular member.

19. The coupling wire guide of any one of the preceding claims, wherein the coupling portion is formed by a helical strip.

20. The coupling wire guide of claim 19, wherein the coupling portion is constructed of a resilient material, the helical strip flexing to receive the previously introduced wire guide.

21. The coupling wire guide of claim 19, wherein the helical strip is structured for partial un-winding and re-winding around the previously introduced wire guide.

22. The coupling wire guide of any one of the preceding claims, further comprising a slot formed in the coupling tip, the slot in communication with the coupling passageway and extending from the proximal port to the distal port, the slot having a width less than a diameter of the previously introduced wire guide.

23. The coupling wire guide of any one of the preceding claims, wherein the main body has an outer diameter greater that an outer diameter of the previously introduced wire guide, and wherein the coupling passageway has a diameter greater than or equal to the outer diameter of the previously introduced wire guide.