Electrolytically severable joint for endovascular embolic devices

0001This invention is an apparatus for endovascular occlusion through the formation of thrombi in arteries, veins, aneurysms, vascular malformations, and arteriovenous fistulas. In particular, it deals with a sacrificial link between an endovascular device which is introduced to and is intended to remain at the desired thrombus formation site and the device used to introduce the device.

0002Approximately 25,000 intracranial aneurysms rupture each year in North America. The primary purpose of treatment for a ruptured intracranial aneurysm is to prevent rebleeding. There are a variety of ways to treat ruptured and non-ruptured aneurysms.

0003Possibly the most widely known of these procedures is an extravascular approach using surgery or microsurgery. This treatment is common with intracranial berry aneurysms. The method comprises a step of clipping the neck of the aneurysm, performing a suture ligation of the neck, or wrapping the entire aneurysm. Each of these procedures is formed by intrusive invasion into the body and performed from the outside of the aneurysm or target site. General anesthesia, craniotomy, brain retraction, and placement of a clip around the neck of the aneurysm are typically required in these surgical procedures. The surgical procedure is often delayed while waiting for the patient to stabilize medically. For this reason, many patients die from the underlying disease or defect prior to the initiation of the procedure.

0004Another procedure -- the extra-intravascular approach -- involves surgically exposing or stereotactically reaching an aneurysm with a probe. The wall of the aneurysm is then perforated from the outside and various techniques are used to occlude the interior in order to prevent it from rebleeding. The techniques used to occlude the aneurysm include electrothrombosis, adhesive embolization, hog hair embolization, and ferromagnetic thrombosis. These procedures are discussed in US-A-5,122,136 (Guglielmi et al.).

0005A still further approach is the least invasive and is additionally described in Guglielmi et al. It is the endovascular approach. In this approach, the interior of the aneurysm is entered by use of a catheter such as those shown in US-A-4,884,579 (Engelson) and also in US-A-4,739,768 (Engelson). These patents describe devices utilizing guidewires and catheters which allow access to the aneurysm from remote portions of the body. Specifically by the use of catheters having very flexible distal regions and guidewires which are steerable to the region of the aneurysm, embolic devices which may be delivered through the catheter are an alternative to the extravascular and extra-intravascular approaches.

0006The endovascular approach typically includes two major sections. The first section involves the introduction of the catheter to the aneurysm site using devices such as shown in the Engelson patents. The second section often involves filling the aneurysm in some fashion or another. For instance, a balloon may be introduced into the aneurysm from the distal portion of the catheter where it is inflated, detached, and left to occlude the aneurysm. In this way, the parent artery is preserved. Balloons are becoming less in favor because of the difficulty in introducing the balloon into the aneurysm sac, the possibility of an aneurysm rupture due to overinflation of the balloon within the aneurysm, and the risk associated with the traction produced when detaching the balloon.

0007A highly desirable embolism-forming device which may be introduced into an aneurysm using endovascular placement procedures, is found in US-A-4,994,069 (Ritchart et al). There is described a device -- typically a platinum/tungsten alloy coil having a very small diameter -- which may be introduced into an aneurysm through a catheter such as those described in Engelson above. These coils are often made of wire having a diameter of 0·05-0·15 mm (2-6 mils). The coil diameter may be 0.25-0.76 mm (10-30 mils). These soft, flexible coils may be of any length desirable and appropriate for the site to be occluded. For instance, the coils may be used to fill a berry aneurysm. Within a short period of time after the filling of the aneurysm with the embolic device, a thrombus forms in the aneurysm and is shortly thereafter complemented with a collagenous material which significantly lessens the potential for aneurysm rupture.

0008Coils such as seen in Ritchart et al. may be delivered to the vasculature site in a variety of ways including, e.g., mechanically detaching them from the delivery device as is shown in US-A-5,250,071 (Palermo) or by electrolytic detachment as is shown in Guglielmi et al. (US-A-5,122,136) as was discussed above.

0009Guglielmi et al. shows an embolism-forming device and procedure for using that device. Specifically, Guglielmi et al. fills a vascular cavity such as an aneurysm with an embolic device such as a platinum coil which coil has been endovascularly delivered. The coil is then severed from its insertion tool by the application of a small electric current. Desirably, the insertion device involves a guidewire which is attached at its distal end to an embolic device by an electrolytic, sacrificial joint. Guglielmi et al. suggests that when the embolic device is a platinum coil, the platinum coil may be 1-50 cm. or longer as is necessary. Proximal of the embolic coil is a guidewire, often stainless steel in construction. The guidewire is used to push the platinum embolic coil, obviously with great gentleness, into the vascular site to be occluded. The patent shows a variety ways of linking the embolic coil to the pusher guidewire. For instance, the guidewire is tapered at its distal end and the distal tip of the guidewire is soldered into the proximal end of the embolic coil. Additionally, a stainless steel coil is wrapped coaxially about the distal tapered portion of the guidewire to provide column strength to the guidewire. This coaxial stainless steel wire is joined both to the guidewire and to the embolic coil. Insulation may be used to cover a portion of the strength-providing stainless steel coil. This arrangement provides for two regions which must be electrolytically severed before the embolic coil is severed from the guidewire.

0010A further variation of the Guglielmi detachable coil is one in which the distal tip of the stainless steel guidewire is not soldered to the proximal end of the embolic device. A simple conical stainless steel wire is included from the stainless steel guidewire to the embolic coil.

0011A further variation found in Guglielmi et al. includes a thin, threadlike extension between the guidewire core and the proximal end of the embolic coil. In this way, the guidewire does not extend to the embolic coil, but instead relies upon a separately introduced extension.

0012WO-A-94/10936, which was published after the priority date of the present invention and can thus at most be admissible as prior art under Article 54(3) EPC, discloses a guidewire in which an elongate tip portion may be severed by electrolytically disintegrating a severable link connecting the tip portion to a core wire. In the Figure 5A embodiment disclosed in this document the tip portion is attached to the core wire at "one or more soldered joints axially spaced apart". Similarly, in the Figure 5B embodiment the elongate tip portion is soldered to one or both ends of a fine wire at the distal tip of the core wire. To detach the elongate tip portion from the guidewire either the soldered joints or some section of the guidewire is electrolytically decomposed.

0013WO-A-93/16650 discloses an embodiment of a guidewire (Figure 6) in which an electrolysing current may be concentrated on a sacrificial stainless steel portion of a detachable tip by disposing an insulating coating on the remaining platinum portion. This concentration of the electrolysing current is referred to as having the effect of decreasing the time required to electrolytically sufficiently disintegrate the steel portion to allow detachment of the platinum tip, which is an advantageous feature where a large aneurism must be treated and a multiple number of coils must be deployed within the aneurysm.

0014According to the present invention there is provided a guidewire for use in combination with a catheter in the formation of a vascular occlusion, the guidewire comprising a core wire (102, 120, 126), having an axis, a proximal portion and a distal portion; and a polymer insulation provided on the proximal portion, the insulation including an insulating end plug (107, 112), the insulated proximal portion not being susceptible to electrolytic disintegration in blood, said distal portion of said core wire extending distally through said end plug (107, 112) to form a single, discrete, sacrificial, severable link (106) susceptible to electrolytic disintegration in blood; the guidewire further comprising an elongate tip portion (104) connected to said distal portion of the core wire (102) via said single link (106), extending distally beyond said core wire (102) and adapted to form said occlusion at a selected site within a mammal vasculature, said elongate tip portion (104) not being susceptible to electrolytic disintegration in blood and being severable from said core wire (102) upon electrolytic disintegration of said single link (106).

0015In the hereinafter described and illustrated embodiments of a guidewire in accordance with the present invention the guidewire has a distal tip which may be introduced into a selected vascular site or cavity. The guidewire is joined to the distal tip or embolic device in such a way that the vascular device may be electrolytically detached by application of a current to the core or guidewire. The improvement involves the use of a discrete, sacrificial link between the core wire and the vascular device co allow clean and quick detachment from the guidewire. The focussed electrolysis found at the sacrificial site reduces the overall possibility of occurrence of multiple electrolysis sites and liberation of large particles from those sites.

0016There are several variations of the sacrificial joint involving extensive electrical insulation about the core wire and any supporting coil devices or the use of direct coating on electrolytically susceptible surfaces.

Brief Description of the Drawings

0017<ul id="ul0001" list-style="none" compact="compact"><li>Figures 1, 2 and 3 show sideview, partial cross-sectional views of variations of the inventive, electrolytically susceptible, sacrificial link between a core wire and an embolic device embodying the invention;</li><li>Figure 4 shows a cross section of the variation shown in Figure 3.</li><li>Figures 5 and 6 are similar views to Figures 1 to 3 of embodiments outside the scope of the present invention.</li><li>Figure 7 shows a close up side view of a variation such as found in Figure 6.</li><li>Figure 8 shows side view of a typically assembly involving the inventive sacrificial link used in this invention.</li><li>Figures 9 and 10 schematically depict the method for deploying the vasoocclusive device using the inventive sacrificial link.</li></ul>

0018Each of the discrete sacrificial joints discussed below may be used in the device shown in US-A-5,122,136.

0019The first of such variations is shown in Figure 1. The assembly <b>100</b> is made up generally of a guide or core wire <b>102</b> which tapers at its distal end to a point and is soldered into the proximal end of a vasoocclusive device <b>104</b>, which in this case is a coil. All of the core wire <b>102</b> is covered with an insulating material such as Teflon®, polyurethane, polyethylene, polypropylene, or other suitable polymeric material, except the most distal exposed joint or sacrificial link <b>106</b>. Link <b>106</b> is not coated with an electrical insulator and is of a material which is susceptible to electrolytic dissolution in blood. The core wire <b>102</b> is typically stainless steel and may be disposed within a protective catheter not shown. Stainless steel guidewire <b>102</b> typically is approximately 0.25-0.76 mm (10-30 mils). in diameter. Often the guidewire is 50-300 cm. in length, that is to say, from the entry site outside the body to sacrificial link <b>106</b>.

0020Sacrificial link <b>106</b> is a discrete link. By "discrete" we mean to say preferably that the joint is substantially dissolved upon release of the vasoocclusive device <b>104</b>. Alternatively, "discrete" may be meant to mean that the length of the link <b>106</b> is no greater than the diameter of the sacrificial link <b>106</b> or that the electrolytic surface present after the vasoocclusive device is released is not substantially greater than would be a circle having the diameter of the sacrificial link <b>106</b>.

0021Also shown in Figure 1 is a coil <b>108</b> which is soldered at its proximal end and, typically, is designed to provide some column strength to the guidewire assembly while not detrimentally affecting the flexibility of the tapered portion of the core wire <b>102</b>. Obviously, in the area where the support coil <b>108</b> is soldered to core wire <b>102</b>, the coating on <b>102</b> is not present so to allow the solder to adhere to metal surfaces. Further, on the distal tip of core wire <b>102</b> is found a pair of insulators: sleeve <b>110</b> and end plug <b>112</b> which serve to further remove the stainless steel coil <b>108</b> from contact with the blood while the step of electrolytic detachment is carried out. Preferably, the end plug <b>112</b> and sleeve <b>110</b> are adhesively attached to each other so to form an electrically insulating or electrolysis-tight housing about coil <b>108</b>. The end plug <b>112</b> and sleeve <b>110</b> form a planar surface in the Figure which is generally planar and perpendicular to the axis of the core wire <b>102</b>.

0022As noted above, the distal end of guidewire or core wire <b>102</b> is inserted into the solder joint <b>114</b> forming the proximal end of vasoocclusive device <b>104</b>.

0023As will be discussed in more detail below, the discrete sacrificial link <b>106</b> is completely or substantially completely dissolved during electrolysis.

0024Figure 2 shows a most preferred variation of the Figure 1 device having a guide or core wire <b>102</b> which may taper at its distal end to a point and which is soldered into the proximal end of a vasoocclusive device <b>104</b>, which in this case is a coil. Similarly, the distal portion of the guidewire <b>102</b> having stainless steel coil <b>108</b> thereabout is all enclosed in an end plug <b>107</b> and sleeve <b>109</b> to provide additional protection to the guidewire and included stainless steel coil <b>108</b>. The major difference between the Figure 1 device and the link assembly shown in Figure 2 is the use of a bias formed distal region. The combination of end plug <b>107</b> and sleeve <b>109</b> allow clear access by blood (and therefore electrolytic current) to the sacrificial link (106). The end plug <b>112</b> and sleeve <b>110</b> form a planar surface in the Figure which is generally planar but not perpendicular to the axis of the core wire <b>102</b>.

0025Obviously, the shape of the surface is, in and of itself, of much criticality except to the extent it allows reasonably free access of the blood to the sacrificial joint <b>106</b>. Curved, slotted, and other variations of the end surface are also contemplated in this invention.

0026Figure 3 shows a variation of the device shown in Figures 1 or 2 in that the core wire <b>102</b> comes down to a point having a sacrificial link <b>106</b> which is soldered into solder joint <b>114</b> in vasoocclusive device <b>104</b>. The coil <b>108</b> provided to give additional column strength to the core wire <b>102</b> is also present. End plug <b>112</b> is also found in this device. The variation is in the outer sleeve <b>116</b>. In this variation, the outer sleeve extends up to and is in contact with the solder joint <b>114</b> found at the end of vasoocclusive device <b>104</b>. To allow the sacrificial link <b>106</b> to have electrical contact with the patient's blood, a sleeve <b>116</b> has a number of openings therein to allow contact of the blood with the sacrificial link <b>106</b>. The openings <b>118</b> may be seen both in Figure 3 and in a cross-section found in Figure 4. The end plug <b>112</b> and the cross-section of the sacrificial link <b>106</b> may also be seen in Figure 4. The variation shown in Figure 3 may have slightly more physical strength but because of the smaller area through openings <b>118</b>, the step of electrolysis may be slightly slower.

0027Figure 5 shows another variation of a sacrificial joint. The device again has a guidewire or core wire <b>120</b> which tapers down to a small point which is soldered into solder joint <b>114</b> on the end of vasoocclusive device <b>104</b>. Again, as with the device in Figures 1, 2, and 3, all except the most distal portion <b>122</b> of core wire <b>120</b> is coated with an insulating material such as Teflon® polymer or other suitable insulating polymers. In this instance, however, the sacrificial link <b>122</b> forming the distal end of core wire <b>120</b> is surrounded, as is a portion of the taper on guidewire <b>120</b> with a release spring <b>124</b>. Release spring <b>124</b> is attached to the guidewire body <b>120</b> but is not attached to the solder joint <b>114</b> on vasoocclusive device <b>104</b>. The release spring <b>124</b> is slightly compressed. It, however, has some space between its adjacent windings as it is found in place on the core wire <b>120</b>. In this way, blood has access to sacrificial link <b>122</b> between the adjacent windings on release spring <b>124.</b> When the sacrificial link <b>122</b> is dissolved, release spring <b>124</b> gently pushes vasoocclusive device <b>104</b> away from the tip of the guidewire or core wire <b>120.</b> Release spring <b>124</b> is completely insulated except, obviously, for the portion which is connected to the core wire <b>120,</b> if welding or soldering of release spring <b>124</b> is had to core wire <b>120.</b>

0028Figure 6 shows a variation of the device in which core wire <b>126</b> tapers down and is either directly soldered to the interior of coil <b>128</b> at solder joint <b>130</b> or is connected to a link which is then soldered at joint <b>130</b>. A support spring <b>132</b> interior to coil <b>128</b> may be used in the same way as was shown in Figures 1, 2, and 3. As a safety factor, coil <b>128</b> and support spring <b>132</b> are fixed to core wire <b>126.</b> The coil <b>128</b> is also electrically connected to core wire <b>126</b>. All of core wire <b>126</b>, coil <b>128</b>, and support spring <b>132</b> are insulated so as to prevent electrolysis upon application of voltage to core wire <b>126</b>. The exception to this insulation is a scribe or score mark <b>134</b> which forms the discrete sacrificial link. Score mark <b>134</b> is shown in more detail on Figure 7. Again, the effect of the scribe or score mark <b>134</b> as shown in Figure 6 is that the electrolysis takes place only at that small area and when the electrolysis has completely severed coil <b>128</b> at that point, there is little potential for electrolysis to take place at any other site on the core wire <b>126</b> or spring <b>128</b>.

0029Vasoocclusive device <b>104</b> is shown in each of the drawings above to be a coil. It may be a coil or a braid or other vasoocclusive device as is already known. The vasoocclusive device may be covered or connected with fibrous materials tied to the outside of the coil or braided onto the outer cover of the coil as desired. Such fibrous adjuvants may be found in US-A-5 382 259 or in US-A-5 226 911

0030Figure 8 shows a typical layout involving the discrete sacrificial joint <b>106</b> as was generally shown in the Figures above. In Figure 8, a somewhat conventional Teflon® laminated or similarly insulated stainless steel guidewire assembly <b>140</b> may be placed within a protective catheter. As was noted above, stainless steel guidewire <b>140</b> may have a diameter of approximately0.25-0.76mm (10-30 mils). In the noted embodiment in Figure 8, guidewire assembly <b>140</b> is tapered at its distal end to form a conical section <b>142</b> which joins a further section <b>144</b> which extends along a length of guidewire <b>146</b>. Section <b>144</b> then gradually narrows down to a thinner section <b>148</b>. The guidewire assembly <b>140</b>, as noted above, may be placed within a catheter body and is typically 50-200 cm. in length down to sacrificial link <b>106</b>. As was shown in Figure 1, the distal section of guidewire assembly <b>140</b> has an outer Teflon® sleeve <b>150</b> (or sleeve of other appropriate insulating material). Furthermore, it has an end plug <b>152</b> to permit isolation of the guidewire electrically from the blood except at sacrificial discrete link <b>106</b>. The proximal end of vasoocclusive device <b>104</b> is typically a soldered tip or a joint <b>114</b>. Preferably, vasoocclusive device <b>104</b>, when a coil forms a secondary loop after it emanates from the end of the catheter. The distal end of vasoocclusive device <b>104</b> may also have an end plug or tip to prevent punctures of the aneurysm when introduced into the aneurysm sac.

0031As noted, the coil or vasoocclusive device <b>104</b> may be pre-biased to form a cylinder or conical envelope. However, the vasoocclusive device <b>104</b> is extremely soft and its overall shape is easily deformed. When inserted within the catheter (not shown), the vasoocclusive device <b>104</b> is easily straightened so to lie axially within the catheter. Once ejected from the tip of the catheter, vasoocclusive device <b>104</b> may form a shape shown in Figure 8 or may be loosely deformed to conform to the interior shape of the aneurysm.

0032Figure 9 shows the placement of the inventive devices shown above within a vessel <b>156</b> with the tip of catheter <b>158</b> placed near neck <b>160</b> of aneurysm <b>162.</b> Vasoocclusive device <b>164</b> is fed into aneurysm <b>162</b> at least until sacrificial link <b>106</b> is exposed beyond the distal tip of the catheter <b>158</b>. A positive electric current of approximately 0.01-2 milli-amps at 0.1-6 volts is applied to guidewire <b>166</b> to form a thrombus within aneurysm <b>162</b>. The negative pole <b>168</b> of power supply <b>170</b> is typically placed in electrical contact with the skin.

0033After the thrombus has been formed and the aneurysm occluded, vasoocclusive device <b>164</b> is detached from guidewire <b>166</b> by electrolytic disintegration of sacrificial link <b>106</b>.

0034After sacrificial link <b>106</b> is completely dissolved by electrolytic action, typically within 3-10 minutes, the guidewire <b>166</b>, catheter <b>156</b>, are removed vessel <b>156</b>, leaving aneurysm <b>162</b> occluded as shown in Figure 10.

0035The process is typically practiced under fluoroscopic control with local anesthesia. A transfemoral catheter is utilized to treat a cerebral aneurysm and is usually introduced at the groin. When the vasoocclusive device <b>164</b> is platinum, it is not effected by electrolysis. When the guidewire and pertinent portions of the supporting coils at the distal tip of the guidewire are adequately coated with insulating coverings, only the exposed portion at the sacrificial link <b>106</b> is effected by the electrolysis.

0036Many alterations and modifications may be made by those having ordinary skill in the art without departing from the scope of the claims. Therefore, it must be understood that the shape of the tip or distal platinum coil used in combination with the guidewire according to the invention may be provided with a variety of shapes and envelopes.

0037The illustrated embodiments have been used only for the purposes of clarity and should not be taken as limiting the invention as defined by the following claims.