WO2007130742A1

WO2007130742A1 - Crossing guide wire with a corrugated shaping ribbon

Info

Publication number: WO2007130742A1
Application number: PCT/US2007/063881
Authority: WO
Inventors: Hancun Chen
Original assignee: Boston Scientific, Limited
Priority date: 2006-05-01
Filing date: 2007-03-13
Publication date: 2007-11-15
Also published as: CA2651014A1; EP2023998A1; CA2651014C; US20070255183A1; JP5253386B2; US8152742B2; JP2009535169A

Abstract

A medical device with a corrugated shaping ribbon is provided, The corrugated shaping ribbon (34) allows for the medical device, which may be provided in the form of a guide wire (20) or catheter, specifically a crossing guide wire or catheter, to more easily navigate through the sometimes tortuous pathways of body lumens In addition, the corrugations (42) effectively provide a mechanism by which energy can be stored as the distal tip of the medical device engages a lesion or other area of occlusion within a blood vessel By storing such energy and continuing to apply force, eventually the distal tip (28) extends thereby releasing the stored energy and allowing the distal tip to advance or cross through the lesion.

Description

CROSSING GUIDE WIRE WITH CORRUGATED SHAPING RIBBON

Field of the Disclosure

[0001] The field of the disclosure generally i elates to medical devices and, more particularly, relates to medical devices foi insertion into body lumens such as blood vessels or other vasculature

Background of the Disclosure

[0002] In many modern medical procedures, it is common to introduce devices intravascular Iy so as to minimize the traumatic effect on the patient For example, in an aiteπotomy, wherein an occlusion or blockage of a blood vessel is widened or cleared so as to improve blood flow, it is common to navigate a balloon catheter to the site of the occlusion, inflate the balloon, and thus expand the diameter of the blood vessel in the location of the occlusion Once expanded, it is often then common to insert a stent to the site of the occlusion so as to hold the blood vessel in an open position and thus prevent the blood vessel walls from contracting radially inwardly after withdrawal of the balloon.

[0003] In order to navigate the balloon catheter to the site of the occlusion, it is first necessary to navigate a guide wire to the location As the balloon catheter itself is relatively soft and malleable, it can not be directed to the site of the occlusion through the blood vessel without a stiffening member along which it can ride That stiffening member is typically provided in the form of the aforementioned guide wire Guide wires themselves are relatively stiff or¹ at least have relatively stiff shafts so as to be easily pushed through the blood vessel by the physician or other technician However, in order¹ to minimize the potential for damage to the blood vessel walls, the distal tip of the guide wire is provided in a relatively soft and malleable form It is common foi the tips of such guide wiies to include a polymer sleeve which is soft enough to bend and contoit as the guide wiie navigates through the sometimes tortuous pathways of the blood vessel, but which also has sufficient strength as provided by the guide wire itself to allow it to be pushed, turned, and otherwise manipulated through the blood vessel It is still further possible to use a shaping ribbon to provide the very distal tip of the guide wire with improved shape-ability

[0004] While effective, it is still desired in the medical community to provide guide wires with even better performance characteristics. Those characteristics include shape-ability, track-ability and cioss-ability. With respect to cross-ability, it is often necessary for the distal tip of the guide wire to cross through the lesion or other occlusion within the blood vessel Such lesions and occlusions are often relatively hard substances which are difficult for the guide wire to advance through given the need foi the guide wire itself to be relatively soft for the purpose of navigating the guide wire through the vasculature. One solution which has been tried has been to make the distal tip of the guide wire relatively haid, but the force with which the guide wire can be advanced is necessarily limited by the overall strength of the entire guide catheter and not just the tip Accordingly, not only must the guide wire have good cross-ability, i e , an ability to cross through a lesion or other occlusion, but good shape-ability as well meaning that it can deflect or otherwise deform as the guide wire is navigated through the vasculature

[0005] A still further attribute which guide wires should have is good track- ability, meaning the ability to follow the sometimes tortuous pathways of human blood vessels In other words, the better the ability of the guide wire to advance through the twists and turns of the blood vessel to get to the site of the occlusion, the better its track-ability Summary of the Disclosure

[0006] In accordance with one aspect of the disclosme, the ciossing guide wiie is disclosed which compiises a core wire having a proximal end and a distal end, a coπugated shaping iibbon extending fiom the distal end of the coie wiie, and a sleeve positioned ovei the coπugated shaping ribbon and at least a poition of the core wire

[0007] In accordance with another aspect of the disclosure, a method of directing a guide wiie to a desiied location with a body lumen is disclosed which compiises introducing the guide wire into a body lumen, the guide wire having a core wire, a coπugated shaping iibbon extending from the core wiie, and a sleeve ovei the corrugated shaping iibbon and at least a portion of the coie wiie, the guide wire teiminating in a distal tip, the corrugated shaping ribbon being defoimable between compressed and un-compiessed states; pushing the guide wire through the body lumen until the distal tip engages a site of occlusion in the body lumen, the coπugated shaping iibbon being deformed into the compiessed state as the guide wire is further pushed; and continuing to push the guide wiie until the coπugated shaping ribbon extends through the site of occlusion, the coπugated shaping iibbon returning to its uncompiessed state after extending through the site of occlusion

[0008] In accoidance with anothei aspect of the disclosuie, a ciossing guide wiie is disclosed which compiises a coie wiie having a pioximal end and a distal end, a spiing extending fiom the coie wiie distal end, and a sleeve positioned ovei the spiing and at least a poition of the coie wiie

[0009] In accoidance with anothei aspect of the disclosuie, a medical device is disclosed which compiises a coie wire having a pioximal end and distal end, the distal end being adapted to navigate through a body lumen, and a spring extending fiom the core wiie distal end

[0010] These and othei aspects and features of the disclosure will become more readily apparent upon reading the following detailed description when taken in conjunction with the accompanying drawings

Brief Description of the Drawings

[0011 ] Fig 1 is a plan view of a illustrative elongate medical device constructed in accordance with the teachings of the disclosure, and shown as a guide wire;

[0012] Fig 2 is an enlarged perspective view of the distal tip of the guide wire of Fig 1;

[0013] Fig 3 is a longitudinal sectional view of Fig 2, taken along line 3-3 of Fig 2;

[0014] Fig 4 is a lateral sectional view of Fig 2, taken along line 4-4 of Hg 2;

[0015] Fig 5 is a perspective view of a guide wire approaching a lesion within a blood vessel;

[0016] Fig 6 is a perspective view similar to Fig 5 but showing the guide wire engaging a lesion within the blood vessel and compressing;

[0017] Fig 7 is a perspective view of a guide wire advancing through the lesion of the blood vessel; and

[0018] Fig 8 is a longitudinal sectional view similar to Fig 3, but showing an alternative embodiment [0019] While the piesent disclosure is susceptible to various modifications and alternative constructions, certain illustrative embodiments thereof have been shown in the drawings and will be described below in detail It should be understood, however, that there is no intention to limit the disclosure to the specific forms disclosed herein, but on the contrary, the intention is to cover all modifications, alternative constructions, and equivalents falling within the spirit and scope of the disclosure as defined by the appended claims.

Detailed Description of the Disclosure

[0020] Referring now to the diawings and with specific reference to fig 1, a plan view of a medical device constructed in accordance with the teachings of the disclosure is generally iefened to by reference numeral 20 In addition, while the depicted medical device is shown in the form of a guide wiie, it is to be understood that the teachings of the disclosure can be used in constructing any number of different medical devices, specifically elongated medical devices for intravascular introduction including, but not limited to, guide catheters, guide wires, balloon catheters, probes, scopes, and the like

[0021] As shown, the guide wire 20 includes a proximal region 22 opposite a distal region 24, with the proximal region including a proximal end 26 and the distal region 24 including a distal tip 28 As one of ordinary skill in the art will readily undei stand, the distal tip 28 is the tip of the guide wire 20 which navigates through a body lumen 30 as shown in Figs 5-7, while the proximal region 22 is the area handled by the physician or technician for pushing, turning, and otherwise manipulating the guide wire 20 as it navigates through the lumen 30 [0022] The guide wire 20 includes a base or coie wire 32 fiom which a shaping iibbon 34 extends at the distal tip 28. A sleeve 36 may extend over the shaping iibbon 34 and at least a poition of the core wiie 32. The coie wire 32 may teiminate in a tapered end 38 and a flatten 40 from which the shaping iibbon 34 extends. In some embodiments, the shaping iibbon 34 is sepaiate fiom the flatten 40 and attached thereto., In other embodiments the shaping iibbon 34 is unitaiy with the flatten 40 and the tapered end 38

[0023] With respect to the materials from which the components can be manufactured, the coie wire 32, as well as the shaping iibbon 34, can be manufactured from any suitable material including, but not limited to, metals, metal alloys, oi any othei suitable mateiial. Some examples of suitable metals and metal alloys include stainless steel, such as 304V, 304L, and 316L stainless steel; alloys including nickel-titanium alloys such as lineal elastic or supei elastic (i e., pseudoelastic) nitinol; nickel-chiomium alloys; nickel -chromium-iron alloys; cobalt alloys; tungsten or tungsten alloys; MP.35-N (having a composition of about 35% Ni, 35% Co, 20% Cr, 9 75% Mo, a maximum 1% Fe, a maximum 1% Ti, a maximum 0 25% C, a maximum 0 15% C a maximum 0.15% Mn, and a maximum 0 15% Si); hastelloy; monel 400; rnconel 825; or the like oi other suitable materials In some embodiments the core wire 32 and shaping iibbon 34 are made from diffeient materials. In other embodiments, the coie wiie 32 and shaping ribbon 34 are made from the same material

[0024] As can be seen from any of Figs. 3 and 5-7, the shaping ribbon 34 includes a plurality of corrugations 42 formed by bending the shaping ribbon 34 at pivot points 44 forming legs 46 therebetween. Accordingly, when a force is directed along the longitudinal axis α of the shaping iibbon 34, the shaping iibbon 34 tends to compiess at pivot points 44 with legs 46 tending to become parallel to one anothei as shown in Fig 6 It is to be undeistood that legs 46 need not come together at angled pivot points 44, but iathei the legs 46 can be connected by flats 47 as shown in Pig 8 With such an embodiment the shaping ribbon 34 would function in much the same fashion, as that of Fig 3, compressing as it engages an occlusion and eventually expanding as it crosses through as more particularly described below

[0025] Such constructions provide many benefits as the guide wire 20 is navigated through the body lumen 30 For example, as shown best in a comparison of Figs 5-7, as the guide wire 20 is navigated through the body lumen 30, the shape- ability of such a construction enables the distal tip 28 to bend and contort as the guide wire 20 navigates through the sometimes tortuous pathway of the body lumen 30 Upon reaching a lesion or other site of occlusion 48 wherein the body lumen 30, the shaping ribbon 34 may not immediately extend through the lesion 48 As such lesions or sites of occlusions 48 are typically of relatively hard material, significant force may need to be applied by the physician or technician at the proximal tip 26 to cause the guide wire 20 to extend through the lesion 48

[0026] Accordingly, as can be seen best in Fig 6, when initial contact is made with the lesion 48 and pressure is applied by the physician, the shaping ribbon 34 will tend to compress as shown therein In so doing, the shaping ribbon 34 serves as a spring storing the energy being applied by the physician at the distal tip 28 within the legs 46 and pivot points 44 and/or flats 47 of the shaping ribbon 34 As additional force is applied by the physician at the distal region 24, eventually, the force applied by the physician and that stored within the shaping ribbon 34 will be sufficient to overcome the strength of the lesion 48, thus allowing the shaping ribbon 34 to expand and extend through the tissue of the lesion 48 This is shown best in Fig 7 [0027] Accordingly, it can be seen that not only does the shape of the ribbon 34 allow foi the necessary shape-ability in the distal tip 28 to allow the guide wire 22 to effectively navigate through the body lumen 30, but the shape also enables sufficient foice to be stoied theiein to facilitate the advancement of the guide wire 20 thiough a lesion or other site of occlusion In addition, by manufacturing the shaping iibbon 34 fiom materials referenced herein, the shaping ribbon 34 is also to ietum to its uncompressed state shown in Fig 5 even after advancing thiough the lesion 48

[0028] Another benefit provided by such a guide wire is its tiack-ability. As one of ordinary skill in the ait will readily understand, guide wires, catheters, and other elongate medical devices are often navigated thiough the body lumen 30 along significant distances to arrive at the site of occlusion, or other desiied location Such body lumens take many twists and turns along the way and it is important that any guide wire be able to follow that path or track The construction of the present disclosure, with its ability to bend and contort, allows for such track- ability. The disclosure also allows for improved torque- ability as well, or in other words, the ability to be twisted or rotated with force, another key attribute of a guide wire.

[0029] Referring nowto Figs 3 and 4, sectional views of the shaping ribbon are provided The lateral sectional view of Fig 4 shows that the lateral cross- sectional shape of the shaping ribbon 34 can be provided in a rectangular configuration However, it is to be understood that the teachings of the disclosure would allow for the shaping iibbon to be manufactured from any number of other lateral cross-sectional shapes including elliptical shapes, circular shapes, oval shapes, square shapes, triangular shapes, and any other polygonal shape

[0030] In addition, the polymer sleeve need not be provided at all In othei words, in some embodiments the guide wire could consist of the core wire 32 and the shaping ribbon 34 However, the provision of the polymei sleeve 36 does allow fbi even greater cross-ability in the guide wire 20 In otdei to even further enhance the cioss-ability oi crossing performance of the guide wire 20, a coating (not shown) could be provided thereon which may be lubiicious, hydiophilic, hydrophobic, a protective, a medicated, or other type of coating Suitable materials for the coating are well known in the ait and may include, but not limited to, silicon, polysulfones, polyfluoiocarbons (such as TEFLON), polyolefms such as polyethylene, polypropylene, polyesters (including polyamides such as nylon), polyur ethanes, polyarylene oxides, polyvinylpyiolidones, polyvinylalcohols, hydroxyl alkyl cellulosics, algins, saccharides, capiolactones, and the like and mixtures and combinations thereof Suitable coating materials may be blended among themselves oi with foimulated amounts of water in soluble compounds (including some polymers) to yield a coating with suitable lubricity, bonding and solubility Some othei examples of such coatings and materials used to create such coatings can be found in U S Patent Nos 5,772,609, and 6,139,510, both of which are incorporated herein by iefeience

[0031] In still fuithei embodiments, the shaping ribbon 34 and/or the coie wire 32 need not be suπounded by a polymei sleeve, but iathei can be surrounded by a coil spiing or the like (not shown) Such an embodiment would still have good shape-ability, cioss-ability, and track-ability as long as its dimensions are kept unifoim through its length

[0032] Based on the foiegoing, it can be seen that the teachings of the present disclosure provide an apparatus and method for constructing and navigating a guide wire through a body lumen The guide wire includes a corrugated distal tip which improves the shape-ability, cioss-ability, and track-ability of the medical device .

[0033 ] In addition, numei ous chai actei istics and advantages of the invention covered by this document have been set fbith in the foi going desciiption. It will be understood, however, that this disclosure is in many respects, only illustrative Changes may be made in details, particularly in the matters of shape, size, and arrangement of parts without exceeding the scope of the invention The invention scope is, of course, defined in the language in which the appended claims ate expressed

Claims

What is claimed is:

1 A guide wiie, comprising:

a coi e wiie having a pioximal end and a distal end;

a coπugated shaping iibbon extending from the distal end of the coie wiie; and

a sleeve positioned ovei the coπugated shaping ribbon and at least a portion of the coie wiie

2 The guide wire of claim 1, wherein the coπugated shaping iibbon is made of metal

3 The guide wiie of claim 2, wheiein the coπugated shaping iibbon is made of stainless steel

4 The guide wiie of claim 2, wheiein the coπugated shaping iibbon is made of inconel

5 The guide wire of claim 1, wherein the coπugated shaping ribbon has a rectangular cross-section

6 The guide wiie of claim 1, wheiein the coπugated shaping iibbon has a polygonal cross-section

7 The guide wiie of claim 1, wheiein the sleeve is made of a polymei

8 A method of diiecting a guide wiie to a desired location within a body lumen, compiising:

introducing the guide wire into a body lumen, the guide wire having a core wire, a coπugated shaping ribbon extending fiom the core wite, and a sleeve over the coiiugated shaping ribbon and at least a portion of the core wire, the guide wire teiminating in a distal tip, the corrugated shaping ribbon being defbrmable between compressed and uncompressed states;

pushing the guide wire through the body lumen until the distal tip engages a site of occlusion in the body lumen, the corrugated shaping ribbon being deformed into the compressed state as the guide wire is further pushed; and

continuing to push the guide wire until the corrugated shaping ribbon extends through the site of occlusion, the corrugated shaping ribbon returning to its uncompressed state after extending through the site of occlusion.

9. A ci o ssing guide wir e, compi ising :

a coi e wire having a proximal end and a distal end;

a spring extending fiom the coie wiie distal end; and

a sleeve positioned ovei the spring and at least a portion of the core wiie

10 The crossing guide wiie of claim 9, wherein the spring is a coπugated wire

1 1 , The crossing guide wire of claim 10, wherein the corrugated wiie has a cross-sectional shape selected fiom the group consisting of rectangular, circulai, oval, square, triangular, and polygonal .

12. The crossing guide wire of claim 10, wherein the spring is manuf actured fiom inconel .

13 The ciossing guide wiie of claim 10, wherein the spring is manufactured fiom stainless steel

14. A medical device, comprising:

a core wire having a proximal end and a distal end, the distal end being adapted to navigate thiough a body lumen; and

a spring extending from the core wiie distal end.

15 The medical device of claim 14, wherein the medical device is a catheter

16. The medical device of claims 14, wherein the medical device is a guide wire.

17. The medical device of claim 16, wherein the medical device is a ciossing guide wire.

18. The medical device of claim 14, wheiein the spring is manufactured of corrugated wire

19. The medical device of claim 14, further including a polymei sleeve over the spring and at least a portion of the core wire

20 The medical device of claim 14, wherein the spring has a cross- sectional shape selected from the group of shapes consisting of rectangular, circular, oval, square, triangular, and polygonal.