CA2055492C - Endovascular electrolytically detachable guidewire tip - Google Patents
Endovascular electrolytically detachable guidewire tip Download PDFInfo
- Publication number
- CA2055492C CA2055492C CA002055492A CA2055492A CA2055492C CA 2055492 C CA2055492 C CA 2055492C CA 002055492 A CA002055492 A CA 002055492A CA 2055492 A CA2055492 A CA 2055492A CA 2055492 C CA2055492 C CA 2055492C
- Authority
- CA
- Canada
- Prior art keywords
- body cavity
- distal tip
- wire
- guidewire
- coil
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime
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Classifications
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- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
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- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
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- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
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- A61B2017/1205—Introduction devices
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- A61B2017/12063—Details concerning the detachment of the occluding device from the introduction device electrolytically detachable
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Abstract
An artery, vein, aneurysm, vascular malformation or arterial fistula is occluded through endovascular electrothrombosis by the endovascular insertion of a platinum guidewire tip (30) into the vascular cavity followed by application of a positive current. The guidewire tip (30) is then separated from the guidewire by electrolytic separation of the tip from the guidewire (10). A portion (26) of the guidewire (10) connected between the tip (30) and the body of the guidewire (10) is comprised of stainless steed and exposed to the bloodstream so that upon continued application of a positive current to the exposed portion, the exposed portion is corroded away at least at one location and the tip (30) is separated from the body of guidewire (10). The guidewire (10) and the microcatheter are thereafter removed leaving the guidewire tip (30) embedded in the thrombus formed within the vascular cavity.
Description
ENDOVASCULAR ELECTROLYTICALLY DETACHABLE GUIDEWIRE TIP
Background of the Invention 1. Field of the Invention The invention relates to a method and apparatus for endovascular electrothrombic formation of thrombi in arteries, veins, aneurysms, vascular malformations and arteriovenous fistulas.
Background of the Invention 1. Field of the Invention The invention relates to a method and apparatus for endovascular electrothrombic formation of thrombi in arteries, veins, aneurysms, vascular malformations and arteriovenous fistulas.
2. Description of the Prior Art Approximately 25,000 intracranial aneurysms rupture every year in North America. The primary purpose of treatment for ruptured intracranial aneurysm is to prevent rebleeding. At the present time, three general methods of WO 91/13592 . PCT/US91/00057 r. J.., Y w'Mll~i 2~~~~
treatment exist, namely an extravascular, endovascular and extra-endovascular approach.
The extravascular approach is comprised of surgery or microsurgery of the aneurysm or treatment site for the $ purpose of preserving the parent artery. This treatment is common with intracranial berry aneurysms. The methodology comprises the step of clipping the neck of the aneurysm, performing a suture-ligation of the neck, or wrapping the entire aneurysm. Each of these surgical procedures is 10 performed by intrusive invasion into the body and performed from outside the aneurysm or target site. General anesthesia, craniotomy, brain rezraczion ana ara~m.~~u dissection around the neck of the aneurysm and placement of a clip are typically required in these surgical procedures.
15 Surgical treatment of vascular intracranial aneurysm can expect a mortality rate of 4-8% with a morbidity rate of 18-20%. Because of the mortality and morbidity rate expected, the surgical procedure is often delayed while waiting for the best surgical time with the result that an additional 20 percentage of patients will die from the underlying disease or defect prior to surgery. For this reason the prior art has sought alternative means of treatment.
In the endovascular approach, the interior vz LuC
aneurysm is entered through the use of a microcatheter.
25 Recently developed microcatheters, such as those shown by Engleson, "Catheter Guidewire", U.S. Patent 4,884,579 and as described in Engleson, "Catheter for Guidewire Tracking", 2C~a'~~ .. .
U.S. Patent 4,739,768 (1988), allow navigation into the cerebral arteries and entry into a cranial aneurysm.
In such procedures a balloon is typically attached to the end of the microcatheter and it is possible to introduce the balloon into the aneurysm, inflate it, and detach it, leaving it to occlude the sac and neck with preservation of the parent artery. While endovascular balloon embolization of berry aneurysms is an attractive method in situations where an extravascular surgical approach is difficult, inflation of a balloon into the aneurysm carries some risk of aneurysm rupture due to possible over-distention of portions of the sac and due to the traction produced while detaching the balloon.
While remedial procedures exist for treating a ruptured 1$ aneurysm during classical extravascular surgery, no satisfactory methodology exists if the aneurysm breaks during an endovascular balloon embolization.
Furthermore, an ideal embolizing agent should adapt itself to the irregular shape of the internal walls of the aneurysm. On the contrary, in a balloon embolization the aneurysmal wall must conform to the shape of the balloon.
This may not lead to a satisfactory result and further increases the risk of rupture.
Still further, balloon embolization is not always possible. If the diameter of the deflated balloon is too great to enter the intracerebral arteries, especially in the cases where there is a vasospasm, complications with ruptured 2G~5~9~: .--r~,.,-~.~a, ;.. .
intracranial aneurysms may occur. The procedure then must be deferred until the spasm is resolved and this then incurs a risk of rebleeding.
In the extra-intravascular approach, an aneurysm is $ surgically exposed or stereotaxically reached 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. These prior art techniques include electrothrombosis, isobutyl-cyanoacrylate embolization, hog-hair embolization and ferromagnetic thrombosis.
In the use of electrothrombosis for extra-intravascular treatment the tip of a positively charged electrode is inserted surgically into the interior of the aneurysm. An 1$ application of the positive charge attracts white blood cells, red blood cells, platelets and fibrinogen which are typically negatively charged at the normal pH of the blood.
The thrombic mass is then formed in the aneurysm about the tip. Thereafter, the tip is removed. See Mullan, "Experiences with Surgical Thrombosis of Intracranial Berry Aneurysms and Carotid Cavernous Fistulas", J. Neurosurg., Vol. 41, December 1974; Hosobuchi, "Electrothrombosis Carotid-Cavernous Fistula", J. Neurosurg., Vol. 42, January 1975: Araki et al., "Electrically Induced Thrombosis for the 2$ Treatment of Intracranial Aneurysms and Angiomas", Excerpta Medica International Congress Series, Amsterdam 1965, Vol.
110, 651-654: Sawyer et al., "Bio-Electric Phenomena as an 2~~5'~9:V
Etiological Factor in Intravascular Thrombosis", Am. J.
Physiol., Vol. 175, 103-107 (1953): J. Piton et al., "Selective Vascular Thrombosis Induced by a Direct Electrical Current: Animal Experiments", J. Neuroradiology, Vol. 5, pages 139-152 (1978). However, each of these techniques involves some type of intrusive procedure to approach the aneurysm from the exterior of the body.
The prior art has also devised the use of a liquid adhesive, isobutyl-cyanoacrylate (IBCA) which polymerizes rapidly on contact with blood to form a firm mass. The liquid adhesive is injected into the aneurysm by puncturing the sac with a small needle. In order to avoid spillage into the parent artery during IBCA injection, blood flow through the parent artery must be momentarily reduced or interrupted.
Alternatively, an inflated balloon may be placed in the artery at the level of the neck of the aneurysm for injection. In addition to the risks caused by temporary blockage of the parent artery, the risks of seepage of such a polymerizing adhesive into the parent artery exists, if it is not completely blocked With consequent occlusion of the artery.
Still further, the prior art has utilized an air gun to inject hog hair through the aneurysm wall to induce internal thrombosis. The success of this procedure involves exposing the aneurysm sufficiently to allow air gun injection and has not been convincingly shown as successful for thrombic formations.
i~~~~~~r i~.:
Ferromagnetic thrombosis in the prior art in extra-intravascular treatments comprises the stereotactic placement of a magnetic probe against the sac of the aneurysm followed by injection into the aneurysm by an injecting needle of iron $ microspheres. Aggregation of the microspheres through the extravascular magnet is followed by interneuysmatic thrombus.
This treatment has not been entirely successful because of the risk of fragmentation of the metallic thrombus when the extravascular magnet is removed. Suspension of the iron powder in methyl methymethacrylate has been used to prevent fragmentation. The treatment has not been favored, because of the need to puncture the aneurysm, the risk of occlusion of the parent artery, the use of unusual and expensive equipment, the need for a craniectomy and general anesthesia, and the necessity to penetrate cerebral tissue to reach the aneurysm.
Endovascular coagulation of blood is also well known in the art and a device using laser optically generated heat is shown by O~Reilly, "Optical Fiber with Attachable Metallic Tip for Intravascular Laser Coagulation of Arteries, Veins, Aneurysms, Vascular Malformation and Arteriovenous Fistulas", U.S. Patent 4,735,201 (1988). See also, O~Reilly et al., "Laser Induced Thermal Occlusion of Berry Aneurysms: Initial Experimental Results", Radiology, Vol. 171, No. 2, pages 471-2$ 74 (1989) . O~Reilly places a tip into an aneurysm by means of an endovascular microcatheter. The tip is adhesively bonded to a optic fiber disposed through the microcatheter.
2~ ~~~9 optical energy is transmitted along the optic fiber from a remote laser at the proximal end of the microcatheter. The optical energy heats the tip to cauterize the tissue surrounding the neck of the aneurysm or other vascular $ opening to be occluded. The catheter is provided with a balloon located on or adjacent to its distal end to cut off blood flow to the site to be cauterized and occluded.
Normally, the blood flow would carry away the heat at the catheter tip, thereby preventing cauterization. The heat in the tip also serves to melt the adhesive used to secure the tip to the distal end of the optical fiber. If all goes well, the tip can be separated from the optical fiber and left in place in the neck of the aneurysm, provided that the cauterization is complete at the same time as the hot melt adhesive melts.
A thrombus is not formed from the heated tip. Instead, blood tissue surrounding the tip is coagulated. Coagulation is a denaturation of protein to form a connective-like tissue similar to that which occurs when the albumen of an egg is heated and coagulates from a clear running liquid to an opaque white solid. The tissue characteristics and composition of the coagulated tissue is therefore substantially distinct from the thrombosis which is formed by the thrombotic aggregation of white and red blood cells, platelets and fibrinogen. The coagulative tissue is substantially softer than a thrombic mass and can therefore more easily be dislodged.
v O'Reilly's device depends at least in part upon the successful cauterization timed to occur no later than the detachment of the heat tip from the optic fiber. The heated tip must also be proportionally sized to the neck of the aneurysm in order to effectively coagulate the tissue surrounding it to form a blockage at the neck. It is believed that the tissue in the interior of the aneurysm remains substantially uncoagulated. In addition, the hot melt adhesive attaching the tip to the optic fiber melts and is dispersed into the adjacent blood tissue where it resolidifies to form free particles within the intracranial blood stream with much the same disadvantage which result from fragmentation of a ferromagnetic electrothrombosis.
Therefore, what is needed is an apparatus and methodology which avoids each of the shortcomings and limitations of the prior art discussed above.
Brief Summary of the Invention The present invention provides an apparatus for forming an occlusion within a body cavity having a fluid disposed therein comprising:
a guidewire adapted to be disposed near an opening into said body cavity;
a separable distal tip of said guidewire adapted for disposition into said body cavity to form said occlusion within said body cavity about said~distal tip; and a detachable coupling between said distal top and said guidewire characterized by nonoptically actuated detachability of said distal tip from said guidewire without necessarily displacing either said distal tip or said guidewire during detachment to leave said distal tip within said body cavity and said occlusion being formed within said body cavity;
whereby said body cavity is occluded by said distal tip, and an occlusion is formed by use of said tip B
~~. 9 without necessarily altering desired placement of said distal tip during detachment or applying any force by said distal tip to any surface within said body cavity.
The present invention also provides a guidewire for use in formation of an occlusion within a body cavity used in combination with a catheter comprising:
a core wire having at least an electrolysable distal portion; and a separable elongate tip portion coupled to and extending from said core wire for a predetermined lineal extent, said separable elongate top portion adapted to form said occlusion in said body cavity and being adapted for insertion within said body cavity, said separable elongate tip portion being resistant to electrolysis compared to said distal portion of said core wire, said separable elongate tip portion being selectively separated from said core wire by electrolysis, whereby occlusion of said body cavity is achieved.
The distal portion is an exposed stainless steel segment.
The stainless steel segment comprises a coil connected at its proximate end to the core wire and connected at its distal end to the tip'portion of the guidewire.
In one embodiment the core wire is extended in a threadlike portion concentrically within the stainless steel coil from the distal end of the stainless steel coil to where the stainless steel coil is connected to the tip portion of the guidewire.
In another embodiment the coil defines an interior space. The interior space is free and unreinforced.
The tip portion is a long and.substantially pliable segment and is comprised of a material not susceptible to electrolytic disintegration within blood.
In one embodiment the long and pliable segment has a length sufficient to substantially fill the vascular cavity when inserted therein.
In a further aspect the present invention provides a guidewire for use information of an occlusion used in combination with a catheter comprising:
an electrolyseable core wire; and a separable elongate tip portion extending said core wire for a predetermined lineal extent and coupled to said distal portion of said core wire, said separable elongate tip portion for insertion within a body cavity, said separable elongate tip portion not resistant to electrolytic disintegration in fluid as compared to said electrolysable core wire, said separable elongate tip portion being separable from said core.wire by electrolysis;
wherein said separable elongate tip portion is a long and substantially flexible segment and is comprised of a metal not susceptible to electrolytic disintegration within fluid; and wherein said long and flexible segment is prebiased to form a helix when extended from said catheter;
whereby occlusion of said body cavity is achievable.
The present invention also provides an apparatus adapted to form an occlusion within a body cavity having fluid disposed therein comprising:
a relaxed coil wire adapted for disposition near an opening into said body cavity, said relaxed coil wire having no substantial memory of its predisposed shape other than at most a relaxed, simple helical shape; and a separable distal tip of said coil wire adapted to be disposed into said body cavity to substantially space occupy said body cavity to mechanically form said occlusion within said body cavity about said separable distal tip; said separable distal tip being characterized as adapted to be non-thermally separated from said coil wire to leave said separable distal tip within said body cavity, wherein non-thermal separation is defined as a detachment without substantially increasing the temperature of said distal tip and wire, wherein said ~°"" 11 separable distal tip is separated from. said coil wire without necessary displacement of said distal tip therefrom and without application of any force between said distal tip and said coil wire;
whereby said body cavity is occluded by said distal tip, and any thrombus formed by use of said tip.
The present invention also provides a coil wire adapted to form an occlusion within a body cavity used in combination with a catheter comprising:
a separable detachable elongate distal tip coupled to and extending from said coil wire for a predetermined lineal extent and adapted to being packed into said body cavity to form said occlusion in said body cavity, said elongate distal tip portion being a relaxed coil having no substantial memory of its predisposed shape other than at most a relaxed, simple helical shape;
whereby occlusion of said body cavity is achievable.
The present invention also provides an improvement in a apparatus adapted to form an occlusion within a body cavity having fluid disposed therein comprising:
a deformable object disposable into said body cavity without tending to induce any preferred geometric form for said body cavity by such disposition, said object being flexible and shapeless, and having substantially no memory of its predisposed shape other than at most a relaxed, simple helical shape, said object being disposed into said body cavity to substantially impede movement of fluid in said body cavity and to thereby form said occlusion with said body cavity;
whereby said body cavity is occluded by said body.
The present invention also provides a wire adapted for form an occlusion within a body cavity used in combination with a catheter comprising:
a coil wire;
a detachable elongate distal tip portion coupled to and extending from said coil wire for a predetermined lineal extent, said detachable elongate distal tip 11a ' portion being adapted to being packed into said body cavity to form said occlusion in said body cavity, said distal tip portion including a first flexible shapeless segment having substantially no memory of its predisposition shape other than at most a relaxed, simple helical shape for disposition into said cavity and a second segment for coupling said first portion to said coil wire, said second segment being adapted to be electrolyzed upon application of current; and an insulating coating disposed on said first segment, said second segment being left exposed to permit selective electrolysis thereof;
whereby occlusion of said body cavity is achieved.
The present invention also provides a apparatus adapted to form an occlusion within a body cavity having fluid disposed therein comprising:
a coil wire adapted for disposition near an opening into said body cavity;
a distal tip coupled to said coil wire adapted to substantially occupy said body cavity to form said occlusion within said body cavity about said distal tip, said distal tip being characterized by being adapted to carry electrical current therethrough to form an electrothrombosis in said body cavity, and being mechanically detachable from said coil wire to leave said distal tip within said body cavity;
whereby said body cavity is occluded by said distal tip, and any thrombus formed by use of said distal tip.
The present invention also provides a apparatus for forming an occlusion within a body cavity having fluid disposed therein:
a coil wire adapted for disposition neat an opening into said body cavity;
a separable distal tip coupled to said coil wire adapted to substantially occupy said cavity to form said occlusion within said body cavity about said distal tip by application of a current to said distal tip which is packed into said cavity; said distal tip being 1 J. b mechanically detachable from said coil wire to leave said distal tip within said body cavity;
whereby said body cavity is occluded by said distal tip, and any thrombus formed by use of said distal tip.
The present invention also provides a guidewire for use in combination with a catheter, said guidewire comprising:
a core wire having a main body and a distal portion;
and a detachable coil for insertion within a body cavity, said detachable coil being coupled to said main body via said distal portion and comprised of material not susceptible to electrolytic disintegration in blood;
wherein said distal portion is susceptible to electrolytic disintegration in blood whereby, on the application of electric current to the guidewire when said detachable coils is disposed in the body cavity, electrothrombosis being performed in the cavity by said detachable coil and at least one portion of said distal portion electrolytically disintegrated to detach said detachable coil from said main body to enable the removal of the main body of the core wire whilst leaving the detached coil within the body cavity.
The present invention also provides an apparatus for forming an occlusion within a body cavity having an ionic fluid therein comprising:
a wire adapted to be disposed near an opening into said body cavity;
a separable distal tip of said wire adapted for disposition into said body cavity to form said occlusion within said body cavity about: said distal tip; and an electrolytically detachable connecting segment coupling said distal tip and said wire.
In a further aspect, the: present invention provides an apparatus for use in formation of an occlusion used in combination with a catheter comprising:
an electrolyzable core wire having a distal portion;
and 11c a separable elongate tip portion extending said core wire and coupled to said distal portion of said core wire, said separable elongate t:ip portion for insertion within a body cavity, said separable elongate tip portion not resistant to electrolytic disintegration in fluid as compared to said electrolyzable core wire, and said separable elongate tip portion being detachable from said wire by electrolysis, wherein said separable elongate tip portion is a long and substantially flexible segment and is comprised of a metal not as susceptible to electrolytic disintegration within fluid as aaid core wire, and wherein said long and flexible segment is prebiased to form a helix when extended from said catheter.
The present invention also provides an apparatus for use in formation of an occlusion within a body cavity comprising:
a wire having at least a e:lectrolyzable distal portion; and a separable elongate tip portion of said wire coupled to and extending from said wire, said separable elongate tip portion adapted to form said occlusion in said body cavity and being adapted for insertion within said body cavity, said separable elongate tip portion being resistant to electrolysis compared to said distal portion of said core wire, said separable elongate tip portion being coupled to said wire by said electrolyzable distal portion.
In a still further aspect, the present invention provides an apparatus for forming an occlusion within a body cavity comprising:
a wire adapted to be disposed near an opening into said body cavity;
a separable distal tip of said wire adapted for disposition into said body cavity to form said occlusion within said body cavity about said distal tip; and a selectively detachable coupling between said distal tip and said wire characterized by detachment of lld said distal tip from said wire without necessarily displacing either said distal tip or said wire during detachment to leave said distal tip within said body cavity with said occlusion being formed within said body cavity, whereby said body cavity is occluded by said distal tip, and an occlusion is formed by use of said tip without necessarily altering desired placement of said distal tip during detachment or applying any force by said distal tip to any surface within said body cavity by reason of said detachment.
The present invention also provides an apparatus for use in formation of an occlusion within a body cavity comprising:
a wire having at least a e:Lectrolyzable distal portion; and a separable elongate tip portion of said wire coupled to and extending from said wire, said separable elongate tip portion adapted to form said occlusion in said body cavity and being adapted for insertion within said body cavity, said separable elongate tip portion being resistant to electrolysis compared to said distal portion of said core wire, said separable elongate tip portion being coupled to said wire by said electrolyzable distal portion, whereby occlusion of said body cavity is achieved.
In a still further aspect, the present invention provides an apparatus for use i:n formation of an occlusion used in combination with a catheter comprising:
an electrolyzable core wire; and a separable elongate tip portion extending said core wire for a predetermined lineal extent and coupled to said distal portion of said core wire, said separable elongate tip portion for insertion within a body cavity, said separable elongate tip portion not resistant to electrolytic disintegration in fluid as compared to said electrolyzable core wire, said separable elongate tip lle portion being separable from said core wire by electrolysis, wherein said separable elongate tip portion is a long and substantially flexible segment and is comprised of a metal not as susceptible to electrolytic disintegration within fluid as said core wire, and wherein said long and flexible segment is prebiased to form a helix when extended from said catheter, whereby occlusion of said body cavity is achieved.
The present invention also provides an apparatus for use in forming an occlusion within a body cavity having an ionic fluid therein having a separable distal tip of a wire disposable into said body cavity to form said occlusion within said body cavity about said distal tip and characterized in that said distal tip is electrolytically detachable from said wire to leave said distal tip within said body cavity with said occlusion being formed within said body cavity.
The present invention also provides an apparatus for use with a catheter to form an occlusion comprising an electrolyzable core wire disposable near the situs of said occlusion, a separable elongate tip portion extending from and coupled to said core wire disposable at said situs of said occlusion, characterized by said separable elongate tip portion being more resistant to electrolytic disintegration in fluid than said electrolyzable core wire, and being a long and substantially flexible segment prebiased to form a helix when extended from said catheter; and having an elongate tip portion from said core wire detachable by electrolysis.
The invention can better be visualized by now turning to the following drawings wherein like elements are referenced by like numerals.
llf Brief Description of the Drawings Figure 1 is an enlarged partially cross-sectioned side view of a first embodiment of the distal end of the guidewire and guidewire tip of i~he invention.
Figure 2 is an enlarged longitudinal cross section of a second embodiment of the guidewire and guidewire tip of the invention.
Figure 3 is an enlarged side view of a third embodiment of the invention with a microcatheter portion cut away in a longitudinal cross-sectional view.
Figure 4 is a simplified depiction of the guidewire of Figure 3 shown disposed within a simple cranial aneurysm.
Figure 5 is a depiction of the microguidewire of Figure 4 shown after electrolytic detachment of the guidewire tip.
Detailed Description of the Breferred Embodiments An artery, vein, aneurysm, vascular malformation or arterial fistula is occluded through endovascular electrothrombosis by the endovascular insertion of a platinum guidewire tip into the vascular cavity followed by application of a positive current. The guidewire tip is then separated from the guidewire by electrolytic separation of the tip from the guidewire. A portion of the guidewire connected between the tip and the body of the guidewire is comprised of stainless steel and exposed to the bloodstream so that upon continued application of a positive current to the exposed portion, the exposed portion is corroded away at least at one location and the tip is separated from the body of the guidewire. The guidewire and the microcatheter are 2~?~~~9w ~.~...
thereafter removed leaving the guidewire tip embedded in the thrombus formed within the vascular cavity.
Figure 1 is an enlarged side view of a first embodiment of the distal end of the guidewire and guidewire tip shown in $ partial cross-sectional view. A conventional Teflon laminated or similarly insulated stainless steel guidewire 10 is disposed within a protective microcatheter (not shown).
Stainless steel guidewire 10 is approximately 0.010 - 0.020 inch (0.254-0.508 mm) in diameter. In the illustrated embodiment, guidewire 10 is tapered at its distal end to form a conical section 12 which joins a section 14 of reduced diameter which extends longitudinally along a length 16 of guidewire 10. Section 16 then narrows gradually down to a thin threadlike portion 18 beginning at a first bonding location 20 and ending at a second bonding location 22.
The stainless steel guidewire 10, comprised of that portion disposed within the microcatheter body, tapered section 12, reduced diameter section 16 and threadlike section 18, is collectively referred to as a core wire which typically is 50 - 300 cm. in length.
In the illustrated embodiment the portion of the core wire extending from tapered section 12 to second bonding location 22 is collectively referred to as the grinding length and may typically be between 20 and 50 cm. in length.
Reduced diameter portion 14 and at least part of sections 12 and first bonding location 20 may be covered with an insulating Teflon laminate 24 which encapsulizes the ' .7:'~ d!"., r.. ~. Y: ~'~".
_ , y. . .. . . . ~w~r°
2c~~~9w underlying portion of guidewire 10 to prevent contact with the blood.
A stainless steel coil 26 is soldered to the proximate end of threadlike portion 18 of guidewire 10 at first bonding location 20. Stainless steel coil 26 is typically 3 to 10 cm. in length and like guidewire 10 has a diameter typically between 0.010 to 0.020 inch (0.254-0.508 mm).
The distal end of stainless steel coil 26 is soldered to the distal end of threadlike portion 18 of guidewire 10 and to the proximal end of a platinum secondary coil 28 at second bonding location 22. Secondary coil 28 itself forms a spiral or helix typically between 2 to 10 mm. in diameter. The helical envelope formed by secondary coil 28 may be cylindrical or conical. Like guidewire 10 and stainless steel coil 26, secondary coil 28 is between approximately 0.010 and 0.020 inch (0.254-0.508 mm) in diameter. The diameter of the wire itself forming stainless steel coil 26 and coil 28 is approximately between 0.001 - 0.005 inch.
The distal end of secondary coil 28 is provided with a platinum soldered tip 30 to form a rounded and smooth termination to avoid puncturing the aneurysm or tearing tissue.
Although prebiased to form a cylindrical or conical envelope, secondary coil 28 is extremely soft and its overall shape is easily deformed. When inserted within the microcatheter (not shown), secondary coil 28 is easily straightened to lie axially within the microcatheter. Once 2~'~5~9, disposed out of the tip of the microcatheter, secondary coil 28 forms the shape shown in Figure 1 and may similarly be loosely deformed to the interior shape of the aneurysm.
As will be described below in greater detail in 5 connection with the third embodiment of Figure 3, after placement of secondary coil 28 within the interior of the aneurysm, a direct current is applied to guidewire 10 from a voltage source exterior to the body. The positive charge on secondary coil 28 within the cavity of the aneurysm causes a 10 thrombus to form within the aneurysm by electrothrombosis.
Detachment of the tip occurs either: (1) by continued application of current for a predetermined time when the portion 18 is exposed to blood: or (2) by movement of the wire to expose portion 18 to blood followed by continued 15 current application for a predeteremined time. Ultimately, both threadlike portion and stainless steel coil 26 will be completely disintegrated at least at one point, thereby allowing guidewire 10 to be withdrawn from the vascular space while leaving secondary coil 28 embedded within the thrombus formed within the aneurysm.
Figure 2 illustrates in enlarged partially cross-sectional view a second embodiment of the invention.
Stainless steel core 32 terminates in a conical distal portion 34. Stainless steel coil 36, shown in cross-sectional view, is soldered to distal portion 34 of guidewire 32 at bonding location 38. The opposing end of the stainless steel coil 36 is provided with a soldered, rounded platinum 2~~5~9w tip 40. In the illustrated embodiment, stainless steel core wire 32 is approximately 0.010 inch in diameter with the length of stainless steel coil 36 being approximately 8 cm.
with the longitudinal length of platinum tip 40 being between 3 and 10 mm. The total length of guidewire 32 from tip 40 to the proximate end is approximately 150 cm.
The embodiment of Figure 2 is utilized in exactly the same manner as described above in connection with Figure 1 to form a thrombic mass within an aneurysm or other vascular cavity. The embodiment of Figure 2 is distinguished from that shown in Figure 1 by the absence of the extension of stainless core 32 through coil 36 to tip 40. In the case of the embodiment of Figure 2 no inner core or reinforcement is provided within stainless steel coil 36. Threadlike portion 18 is provided in the embodiment of Figure 1 to allow increased tensile strength of the guidewire. However, a degree of flexibility of the guidewire is sacrificed by the inclusion even of threadlike tip 18, so that the embodiment of Figure 2 provides a more flexible tip, at least for that portion of the microguidewire constituting the stainless steel coil 36.
It is expressly understood that the helical secondary coil tip of the embodiment of Figure 1 could similarly be attached to stainless steel coil 36 of the embodiment of Figure 2 without departing from the spirit and scope of the invention.
17 i~~~ J.~ 9~
Thinned and threadlike portion guidewires disposed concentrically within coiled portions are well known and are shown in Antoshkiv, "Disposable Guidewire", U.S. Patent 3,789,841 (1974): 8epstxa et al., "Guidewire Device", U.S.
5 Patent 4,832,047 (1989): Engleson, "Catheter Guidewire", U.S.
Patent 4,884,579 (1989): Samson et al., "Guidewire for Catheters", U.S. Patent 4,538,622 (1985): and Samson et al., "Catheter Guidewire with Short Spring Tip and Method of Using the Same", U.S. Patent 4,554,929 (1985).
10 Turn now to the third embodiment of the invention as shown in Figure 3. Figure 3 shows an enlarged side view of a guidewire, generally denoted by reference numeral 42, disposed within a microcatheter 44 shown in cross-sectional view. Like the embodiment of Figure 1, a stainless steel 15 coil 46 is soldered to a conical portion 48 of guidewire 22 at a first bonding location 50. A thin threadlike extension 52 is then longitudinally disposed within stainless steel coil 46 to a second bonding location 54 where stainless steel guidewire 46 and threadlike portion 52 are soldered to a soft 20 platinum coil 56. Platinum coil 56 is not prebiased, nor does it contain any internal reinforcement, but is a free and open coil similar in that respect to stainless steel coil 36 of the embodiment of Figure 2.
However, platinum coil 56 is particularly distinguished 25 by its length of approximately 1 to 50 cm. and by its flexibility. The platinum or platinum alloy used is particularly pliable and the diameter of the wire used to F._ _ .,";J i~~ . . 18 n y'~,, - ' 1:' ~'~~,.
form platinum coil 56 is approximately 0.001 - 0.005 inch in diameter. The distal end of platinum coil 56 is provided with a smooth and rounded platinum tip 58 similar in that respect to tips 30 and 40 of Figures 1 and 2, respectively.
$ When coil 56 is disposed within microcatheter 54, it lies along the longitudinal lumen 60 defined by microcatheter 44. The distal end 62 of microcatheter 60 is then placed into the neck of the aneurysm and the guidewire 42 is advanced, thereby feeding tip 58 in platinum coil 56 into aneurysm 64 until bonding location 50 resides in the neck of the aneurysm as best depicted in the diagrammatic cross-sectional view of Figure 4.
Figure 4 illustrates the insertion of the embodiment of Figure 3 within a vessel 66 with distal tip of microcatheter 44 positioned near neck 68 of aneurysm 64. Coil 56 is fed into aneurysm 64 until at least a portion of stainless steel coil 46 is exposed beyond the distal tip 62 of microcatheter 44. A positive electric current of approximately 0.01 to 2 milliamps at 0.1 - 6 volts is applied to guidewire 42 to form the thrombus. Typically a thrombus will form within three to five minutes. The negative pole 72 of voltage source 70 is typically placed over and in contact with the skin.
After the thrombus has been formed and the aneurysm completely occluded, tip 58 and coil 56 are detached from guidewire 42 by electrolytic disintegration of at least one portion of stainless steel coil 46. In the illustrated embodiment this is accomplished by continued application of 19 2~~5%~9w .
current until the total time of current application is almost approximately four minutes.
At least one portion of stainless steel coil 46 will be completely dissolved through by electrolytic action within 3 to 10 minutes, usually about 4 minutes. After separation by electrolytic disintegration, guidewire 42, microcatheter 44 and the remaining portion of coil 46 still attached to guidewire 42 are removed from vessel 66, leaving aneurysm 64 completely occluded as diagrammatically depicted in Figure 5 by thrombus 74. It will be appreciated that the time of disintegration may be varied by altering the dimensions of the portions of the wire and/or the current.
The process is practiced under fluoroscopic control with local anesthesia at the groin. A transfemoral microcatheter is utilized to treat the cerebral aneurysm. The platinum is not affected by electrolysis and the remaining portions of the microcatheter are insulated either by a Teflon lamination directly on guidewire 42 and/or by microcatheter 44. Only the exposed portion of the guidewire 46 is affected by the electrolysis.
It has further been discovered that thrombus 74 continues to form even after detachment from guidewire 42.
It is believed that a positive charge is retained on or near coil 56 which therefore continues to attract platelets, white brood cells, red blood cells and fibrinogen within aneurysm 64.
_,~y2~~ i~9~
Many alterations and modifications may be made by those having ordinary skill in the art without departing from the spirit and scope of the invention. Therefore, it must be understood that the shape of the tip or distal platinum coil 5 used in combination with the guidewire according to the invention may be provided with a variety of shapes and envelopes. In addition thereto, the composition of the microguidewire tip may be made of elements other than platinum including stainless steel, beryllium, copper and 10 various alloys of the same with or without platinum. Still further, the diameter of the guidewire, various of the guidewire described above and the stainless steel coil immediately proximal to the detachable tip may be provided with differing diameters or cross sections to vary the times 15 and current magnitudes necessary in order to effectuate electrolytic detachment from the tip. Still further, the invention may include conventional electronics connected to the proximal end of the guidewire for determining the exact instant of detachment of the distal tip from the guidewire.
20 Therefore, the illustrated embodiment has been set forth only for the purposes of clarity and example and should not be taken as limiting the invention as defined by the following claims, which include all equivalent means whether now known or later devised.
treatment exist, namely an extravascular, endovascular and extra-endovascular approach.
The extravascular approach is comprised of surgery or microsurgery of the aneurysm or treatment site for the $ purpose of preserving the parent artery. This treatment is common with intracranial berry aneurysms. The methodology comprises the step of clipping the neck of the aneurysm, performing a suture-ligation of the neck, or wrapping the entire aneurysm. Each of these surgical procedures is 10 performed by intrusive invasion into the body and performed from outside the aneurysm or target site. General anesthesia, craniotomy, brain rezraczion ana ara~m.~~u dissection around the neck of the aneurysm and placement of a clip are typically required in these surgical procedures.
15 Surgical treatment of vascular intracranial aneurysm can expect a mortality rate of 4-8% with a morbidity rate of 18-20%. Because of the mortality and morbidity rate expected, the surgical procedure is often delayed while waiting for the best surgical time with the result that an additional 20 percentage of patients will die from the underlying disease or defect prior to surgery. For this reason the prior art has sought alternative means of treatment.
In the endovascular approach, the interior vz LuC
aneurysm is entered through the use of a microcatheter.
25 Recently developed microcatheters, such as those shown by Engleson, "Catheter Guidewire", U.S. Patent 4,884,579 and as described in Engleson, "Catheter for Guidewire Tracking", 2C~a'~~ .. .
U.S. Patent 4,739,768 (1988), allow navigation into the cerebral arteries and entry into a cranial aneurysm.
In such procedures a balloon is typically attached to the end of the microcatheter and it is possible to introduce the balloon into the aneurysm, inflate it, and detach it, leaving it to occlude the sac and neck with preservation of the parent artery. While endovascular balloon embolization of berry aneurysms is an attractive method in situations where an extravascular surgical approach is difficult, inflation of a balloon into the aneurysm carries some risk of aneurysm rupture due to possible over-distention of portions of the sac and due to the traction produced while detaching the balloon.
While remedial procedures exist for treating a ruptured 1$ aneurysm during classical extravascular surgery, no satisfactory methodology exists if the aneurysm breaks during an endovascular balloon embolization.
Furthermore, an ideal embolizing agent should adapt itself to the irregular shape of the internal walls of the aneurysm. On the contrary, in a balloon embolization the aneurysmal wall must conform to the shape of the balloon.
This may not lead to a satisfactory result and further increases the risk of rupture.
Still further, balloon embolization is not always possible. If the diameter of the deflated balloon is too great to enter the intracerebral arteries, especially in the cases where there is a vasospasm, complications with ruptured 2G~5~9~: .--r~,.,-~.~a, ;.. .
intracranial aneurysms may occur. The procedure then must be deferred until the spasm is resolved and this then incurs a risk of rebleeding.
In the extra-intravascular approach, an aneurysm is $ surgically exposed or stereotaxically reached 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. These prior art techniques include electrothrombosis, isobutyl-cyanoacrylate embolization, hog-hair embolization and ferromagnetic thrombosis.
In the use of electrothrombosis for extra-intravascular treatment the tip of a positively charged electrode is inserted surgically into the interior of the aneurysm. An 1$ application of the positive charge attracts white blood cells, red blood cells, platelets and fibrinogen which are typically negatively charged at the normal pH of the blood.
The thrombic mass is then formed in the aneurysm about the tip. Thereafter, the tip is removed. See Mullan, "Experiences with Surgical Thrombosis of Intracranial Berry Aneurysms and Carotid Cavernous Fistulas", J. Neurosurg., Vol. 41, December 1974; Hosobuchi, "Electrothrombosis Carotid-Cavernous Fistula", J. Neurosurg., Vol. 42, January 1975: Araki et al., "Electrically Induced Thrombosis for the 2$ Treatment of Intracranial Aneurysms and Angiomas", Excerpta Medica International Congress Series, Amsterdam 1965, Vol.
110, 651-654: Sawyer et al., "Bio-Electric Phenomena as an 2~~5'~9:V
Etiological Factor in Intravascular Thrombosis", Am. J.
Physiol., Vol. 175, 103-107 (1953): J. Piton et al., "Selective Vascular Thrombosis Induced by a Direct Electrical Current: Animal Experiments", J. Neuroradiology, Vol. 5, pages 139-152 (1978). However, each of these techniques involves some type of intrusive procedure to approach the aneurysm from the exterior of the body.
The prior art has also devised the use of a liquid adhesive, isobutyl-cyanoacrylate (IBCA) which polymerizes rapidly on contact with blood to form a firm mass. The liquid adhesive is injected into the aneurysm by puncturing the sac with a small needle. In order to avoid spillage into the parent artery during IBCA injection, blood flow through the parent artery must be momentarily reduced or interrupted.
Alternatively, an inflated balloon may be placed in the artery at the level of the neck of the aneurysm for injection. In addition to the risks caused by temporary blockage of the parent artery, the risks of seepage of such a polymerizing adhesive into the parent artery exists, if it is not completely blocked With consequent occlusion of the artery.
Still further, the prior art has utilized an air gun to inject hog hair through the aneurysm wall to induce internal thrombosis. The success of this procedure involves exposing the aneurysm sufficiently to allow air gun injection and has not been convincingly shown as successful for thrombic formations.
i~~~~~~r i~.:
Ferromagnetic thrombosis in the prior art in extra-intravascular treatments comprises the stereotactic placement of a magnetic probe against the sac of the aneurysm followed by injection into the aneurysm by an injecting needle of iron $ microspheres. Aggregation of the microspheres through the extravascular magnet is followed by interneuysmatic thrombus.
This treatment has not been entirely successful because of the risk of fragmentation of the metallic thrombus when the extravascular magnet is removed. Suspension of the iron powder in methyl methymethacrylate has been used to prevent fragmentation. The treatment has not been favored, because of the need to puncture the aneurysm, the risk of occlusion of the parent artery, the use of unusual and expensive equipment, the need for a craniectomy and general anesthesia, and the necessity to penetrate cerebral tissue to reach the aneurysm.
Endovascular coagulation of blood is also well known in the art and a device using laser optically generated heat is shown by O~Reilly, "Optical Fiber with Attachable Metallic Tip for Intravascular Laser Coagulation of Arteries, Veins, Aneurysms, Vascular Malformation and Arteriovenous Fistulas", U.S. Patent 4,735,201 (1988). See also, O~Reilly et al., "Laser Induced Thermal Occlusion of Berry Aneurysms: Initial Experimental Results", Radiology, Vol. 171, No. 2, pages 471-2$ 74 (1989) . O~Reilly places a tip into an aneurysm by means of an endovascular microcatheter. The tip is adhesively bonded to a optic fiber disposed through the microcatheter.
2~ ~~~9 optical energy is transmitted along the optic fiber from a remote laser at the proximal end of the microcatheter. The optical energy heats the tip to cauterize the tissue surrounding the neck of the aneurysm or other vascular $ opening to be occluded. The catheter is provided with a balloon located on or adjacent to its distal end to cut off blood flow to the site to be cauterized and occluded.
Normally, the blood flow would carry away the heat at the catheter tip, thereby preventing cauterization. The heat in the tip also serves to melt the adhesive used to secure the tip to the distal end of the optical fiber. If all goes well, the tip can be separated from the optical fiber and left in place in the neck of the aneurysm, provided that the cauterization is complete at the same time as the hot melt adhesive melts.
A thrombus is not formed from the heated tip. Instead, blood tissue surrounding the tip is coagulated. Coagulation is a denaturation of protein to form a connective-like tissue similar to that which occurs when the albumen of an egg is heated and coagulates from a clear running liquid to an opaque white solid. The tissue characteristics and composition of the coagulated tissue is therefore substantially distinct from the thrombosis which is formed by the thrombotic aggregation of white and red blood cells, platelets and fibrinogen. The coagulative tissue is substantially softer than a thrombic mass and can therefore more easily be dislodged.
v O'Reilly's device depends at least in part upon the successful cauterization timed to occur no later than the detachment of the heat tip from the optic fiber. The heated tip must also be proportionally sized to the neck of the aneurysm in order to effectively coagulate the tissue surrounding it to form a blockage at the neck. It is believed that the tissue in the interior of the aneurysm remains substantially uncoagulated. In addition, the hot melt adhesive attaching the tip to the optic fiber melts and is dispersed into the adjacent blood tissue where it resolidifies to form free particles within the intracranial blood stream with much the same disadvantage which result from fragmentation of a ferromagnetic electrothrombosis.
Therefore, what is needed is an apparatus and methodology which avoids each of the shortcomings and limitations of the prior art discussed above.
Brief Summary of the Invention The present invention provides an apparatus for forming an occlusion within a body cavity having a fluid disposed therein comprising:
a guidewire adapted to be disposed near an opening into said body cavity;
a separable distal tip of said guidewire adapted for disposition into said body cavity to form said occlusion within said body cavity about said~distal tip; and a detachable coupling between said distal top and said guidewire characterized by nonoptically actuated detachability of said distal tip from said guidewire without necessarily displacing either said distal tip or said guidewire during detachment to leave said distal tip within said body cavity and said occlusion being formed within said body cavity;
whereby said body cavity is occluded by said distal tip, and an occlusion is formed by use of said tip B
~~. 9 without necessarily altering desired placement of said distal tip during detachment or applying any force by said distal tip to any surface within said body cavity.
The present invention also provides a guidewire for use in formation of an occlusion within a body cavity used in combination with a catheter comprising:
a core wire having at least an electrolysable distal portion; and a separable elongate tip portion coupled to and extending from said core wire for a predetermined lineal extent, said separable elongate top portion adapted to form said occlusion in said body cavity and being adapted for insertion within said body cavity, said separable elongate tip portion being resistant to electrolysis compared to said distal portion of said core wire, said separable elongate tip portion being selectively separated from said core wire by electrolysis, whereby occlusion of said body cavity is achieved.
The distal portion is an exposed stainless steel segment.
The stainless steel segment comprises a coil connected at its proximate end to the core wire and connected at its distal end to the tip'portion of the guidewire.
In one embodiment the core wire is extended in a threadlike portion concentrically within the stainless steel coil from the distal end of the stainless steel coil to where the stainless steel coil is connected to the tip portion of the guidewire.
In another embodiment the coil defines an interior space. The interior space is free and unreinforced.
The tip portion is a long and.substantially pliable segment and is comprised of a material not susceptible to electrolytic disintegration within blood.
In one embodiment the long and pliable segment has a length sufficient to substantially fill the vascular cavity when inserted therein.
In a further aspect the present invention provides a guidewire for use information of an occlusion used in combination with a catheter comprising:
an electrolyseable core wire; and a separable elongate tip portion extending said core wire for a predetermined lineal extent and coupled to said distal portion of said core wire, said separable elongate tip portion for insertion within a body cavity, said separable elongate tip portion not resistant to electrolytic disintegration in fluid as compared to said electrolysable core wire, said separable elongate tip portion being separable from said core.wire by electrolysis;
wherein said separable elongate tip portion is a long and substantially flexible segment and is comprised of a metal not susceptible to electrolytic disintegration within fluid; and wherein said long and flexible segment is prebiased to form a helix when extended from said catheter;
whereby occlusion of said body cavity is achievable.
The present invention also provides an apparatus adapted to form an occlusion within a body cavity having fluid disposed therein comprising:
a relaxed coil wire adapted for disposition near an opening into said body cavity, said relaxed coil wire having no substantial memory of its predisposed shape other than at most a relaxed, simple helical shape; and a separable distal tip of said coil wire adapted to be disposed into said body cavity to substantially space occupy said body cavity to mechanically form said occlusion within said body cavity about said separable distal tip; said separable distal tip being characterized as adapted to be non-thermally separated from said coil wire to leave said separable distal tip within said body cavity, wherein non-thermal separation is defined as a detachment without substantially increasing the temperature of said distal tip and wire, wherein said ~°"" 11 separable distal tip is separated from. said coil wire without necessary displacement of said distal tip therefrom and without application of any force between said distal tip and said coil wire;
whereby said body cavity is occluded by said distal tip, and any thrombus formed by use of said tip.
The present invention also provides a coil wire adapted to form an occlusion within a body cavity used in combination with a catheter comprising:
a separable detachable elongate distal tip coupled to and extending from said coil wire for a predetermined lineal extent and adapted to being packed into said body cavity to form said occlusion in said body cavity, said elongate distal tip portion being a relaxed coil having no substantial memory of its predisposed shape other than at most a relaxed, simple helical shape;
whereby occlusion of said body cavity is achievable.
The present invention also provides an improvement in a apparatus adapted to form an occlusion within a body cavity having fluid disposed therein comprising:
a deformable object disposable into said body cavity without tending to induce any preferred geometric form for said body cavity by such disposition, said object being flexible and shapeless, and having substantially no memory of its predisposed shape other than at most a relaxed, simple helical shape, said object being disposed into said body cavity to substantially impede movement of fluid in said body cavity and to thereby form said occlusion with said body cavity;
whereby said body cavity is occluded by said body.
The present invention also provides a wire adapted for form an occlusion within a body cavity used in combination with a catheter comprising:
a coil wire;
a detachable elongate distal tip portion coupled to and extending from said coil wire for a predetermined lineal extent, said detachable elongate distal tip 11a ' portion being adapted to being packed into said body cavity to form said occlusion in said body cavity, said distal tip portion including a first flexible shapeless segment having substantially no memory of its predisposition shape other than at most a relaxed, simple helical shape for disposition into said cavity and a second segment for coupling said first portion to said coil wire, said second segment being adapted to be electrolyzed upon application of current; and an insulating coating disposed on said first segment, said second segment being left exposed to permit selective electrolysis thereof;
whereby occlusion of said body cavity is achieved.
The present invention also provides a apparatus adapted to form an occlusion within a body cavity having fluid disposed therein comprising:
a coil wire adapted for disposition near an opening into said body cavity;
a distal tip coupled to said coil wire adapted to substantially occupy said body cavity to form said occlusion within said body cavity about said distal tip, said distal tip being characterized by being adapted to carry electrical current therethrough to form an electrothrombosis in said body cavity, and being mechanically detachable from said coil wire to leave said distal tip within said body cavity;
whereby said body cavity is occluded by said distal tip, and any thrombus formed by use of said distal tip.
The present invention also provides a apparatus for forming an occlusion within a body cavity having fluid disposed therein:
a coil wire adapted for disposition neat an opening into said body cavity;
a separable distal tip coupled to said coil wire adapted to substantially occupy said cavity to form said occlusion within said body cavity about said distal tip by application of a current to said distal tip which is packed into said cavity; said distal tip being 1 J. b mechanically detachable from said coil wire to leave said distal tip within said body cavity;
whereby said body cavity is occluded by said distal tip, and any thrombus formed by use of said distal tip.
The present invention also provides a guidewire for use in combination with a catheter, said guidewire comprising:
a core wire having a main body and a distal portion;
and a detachable coil for insertion within a body cavity, said detachable coil being coupled to said main body via said distal portion and comprised of material not susceptible to electrolytic disintegration in blood;
wherein said distal portion is susceptible to electrolytic disintegration in blood whereby, on the application of electric current to the guidewire when said detachable coils is disposed in the body cavity, electrothrombosis being performed in the cavity by said detachable coil and at least one portion of said distal portion electrolytically disintegrated to detach said detachable coil from said main body to enable the removal of the main body of the core wire whilst leaving the detached coil within the body cavity.
The present invention also provides an apparatus for forming an occlusion within a body cavity having an ionic fluid therein comprising:
a wire adapted to be disposed near an opening into said body cavity;
a separable distal tip of said wire adapted for disposition into said body cavity to form said occlusion within said body cavity about: said distal tip; and an electrolytically detachable connecting segment coupling said distal tip and said wire.
In a further aspect, the: present invention provides an apparatus for use in formation of an occlusion used in combination with a catheter comprising:
an electrolyzable core wire having a distal portion;
and 11c a separable elongate tip portion extending said core wire and coupled to said distal portion of said core wire, said separable elongate t:ip portion for insertion within a body cavity, said separable elongate tip portion not resistant to electrolytic disintegration in fluid as compared to said electrolyzable core wire, and said separable elongate tip portion being detachable from said wire by electrolysis, wherein said separable elongate tip portion is a long and substantially flexible segment and is comprised of a metal not as susceptible to electrolytic disintegration within fluid as aaid core wire, and wherein said long and flexible segment is prebiased to form a helix when extended from said catheter.
The present invention also provides an apparatus for use in formation of an occlusion within a body cavity comprising:
a wire having at least a e:lectrolyzable distal portion; and a separable elongate tip portion of said wire coupled to and extending from said wire, said separable elongate tip portion adapted to form said occlusion in said body cavity and being adapted for insertion within said body cavity, said separable elongate tip portion being resistant to electrolysis compared to said distal portion of said core wire, said separable elongate tip portion being coupled to said wire by said electrolyzable distal portion.
In a still further aspect, the present invention provides an apparatus for forming an occlusion within a body cavity comprising:
a wire adapted to be disposed near an opening into said body cavity;
a separable distal tip of said wire adapted for disposition into said body cavity to form said occlusion within said body cavity about said distal tip; and a selectively detachable coupling between said distal tip and said wire characterized by detachment of lld said distal tip from said wire without necessarily displacing either said distal tip or said wire during detachment to leave said distal tip within said body cavity with said occlusion being formed within said body cavity, whereby said body cavity is occluded by said distal tip, and an occlusion is formed by use of said tip without necessarily altering desired placement of said distal tip during detachment or applying any force by said distal tip to any surface within said body cavity by reason of said detachment.
The present invention also provides an apparatus for use in formation of an occlusion within a body cavity comprising:
a wire having at least a e:Lectrolyzable distal portion; and a separable elongate tip portion of said wire coupled to and extending from said wire, said separable elongate tip portion adapted to form said occlusion in said body cavity and being adapted for insertion within said body cavity, said separable elongate tip portion being resistant to electrolysis compared to said distal portion of said core wire, said separable elongate tip portion being coupled to said wire by said electrolyzable distal portion, whereby occlusion of said body cavity is achieved.
In a still further aspect, the present invention provides an apparatus for use i:n formation of an occlusion used in combination with a catheter comprising:
an electrolyzable core wire; and a separable elongate tip portion extending said core wire for a predetermined lineal extent and coupled to said distal portion of said core wire, said separable elongate tip portion for insertion within a body cavity, said separable elongate tip portion not resistant to electrolytic disintegration in fluid as compared to said electrolyzable core wire, said separable elongate tip lle portion being separable from said core wire by electrolysis, wherein said separable elongate tip portion is a long and substantially flexible segment and is comprised of a metal not as susceptible to electrolytic disintegration within fluid as said core wire, and wherein said long and flexible segment is prebiased to form a helix when extended from said catheter, whereby occlusion of said body cavity is achieved.
The present invention also provides an apparatus for use in forming an occlusion within a body cavity having an ionic fluid therein having a separable distal tip of a wire disposable into said body cavity to form said occlusion within said body cavity about said distal tip and characterized in that said distal tip is electrolytically detachable from said wire to leave said distal tip within said body cavity with said occlusion being formed within said body cavity.
The present invention also provides an apparatus for use with a catheter to form an occlusion comprising an electrolyzable core wire disposable near the situs of said occlusion, a separable elongate tip portion extending from and coupled to said core wire disposable at said situs of said occlusion, characterized by said separable elongate tip portion being more resistant to electrolytic disintegration in fluid than said electrolyzable core wire, and being a long and substantially flexible segment prebiased to form a helix when extended from said catheter; and having an elongate tip portion from said core wire detachable by electrolysis.
The invention can better be visualized by now turning to the following drawings wherein like elements are referenced by like numerals.
llf Brief Description of the Drawings Figure 1 is an enlarged partially cross-sectioned side view of a first embodiment of the distal end of the guidewire and guidewire tip of i~he invention.
Figure 2 is an enlarged longitudinal cross section of a second embodiment of the guidewire and guidewire tip of the invention.
Figure 3 is an enlarged side view of a third embodiment of the invention with a microcatheter portion cut away in a longitudinal cross-sectional view.
Figure 4 is a simplified depiction of the guidewire of Figure 3 shown disposed within a simple cranial aneurysm.
Figure 5 is a depiction of the microguidewire of Figure 4 shown after electrolytic detachment of the guidewire tip.
Detailed Description of the Breferred Embodiments An artery, vein, aneurysm, vascular malformation or arterial fistula is occluded through endovascular electrothrombosis by the endovascular insertion of a platinum guidewire tip into the vascular cavity followed by application of a positive current. The guidewire tip is then separated from the guidewire by electrolytic separation of the tip from the guidewire. A portion of the guidewire connected between the tip and the body of the guidewire is comprised of stainless steel and exposed to the bloodstream so that upon continued application of a positive current to the exposed portion, the exposed portion is corroded away at least at one location and the tip is separated from the body of the guidewire. The guidewire and the microcatheter are 2~?~~~9w ~.~...
thereafter removed leaving the guidewire tip embedded in the thrombus formed within the vascular cavity.
Figure 1 is an enlarged side view of a first embodiment of the distal end of the guidewire and guidewire tip shown in $ partial cross-sectional view. A conventional Teflon laminated or similarly insulated stainless steel guidewire 10 is disposed within a protective microcatheter (not shown).
Stainless steel guidewire 10 is approximately 0.010 - 0.020 inch (0.254-0.508 mm) in diameter. In the illustrated embodiment, guidewire 10 is tapered at its distal end to form a conical section 12 which joins a section 14 of reduced diameter which extends longitudinally along a length 16 of guidewire 10. Section 16 then narrows gradually down to a thin threadlike portion 18 beginning at a first bonding location 20 and ending at a second bonding location 22.
The stainless steel guidewire 10, comprised of that portion disposed within the microcatheter body, tapered section 12, reduced diameter section 16 and threadlike section 18, is collectively referred to as a core wire which typically is 50 - 300 cm. in length.
In the illustrated embodiment the portion of the core wire extending from tapered section 12 to second bonding location 22 is collectively referred to as the grinding length and may typically be between 20 and 50 cm. in length.
Reduced diameter portion 14 and at least part of sections 12 and first bonding location 20 may be covered with an insulating Teflon laminate 24 which encapsulizes the ' .7:'~ d!"., r.. ~. Y: ~'~".
_ , y. . .. . . . ~w~r°
2c~~~9w underlying portion of guidewire 10 to prevent contact with the blood.
A stainless steel coil 26 is soldered to the proximate end of threadlike portion 18 of guidewire 10 at first bonding location 20. Stainless steel coil 26 is typically 3 to 10 cm. in length and like guidewire 10 has a diameter typically between 0.010 to 0.020 inch (0.254-0.508 mm).
The distal end of stainless steel coil 26 is soldered to the distal end of threadlike portion 18 of guidewire 10 and to the proximal end of a platinum secondary coil 28 at second bonding location 22. Secondary coil 28 itself forms a spiral or helix typically between 2 to 10 mm. in diameter. The helical envelope formed by secondary coil 28 may be cylindrical or conical. Like guidewire 10 and stainless steel coil 26, secondary coil 28 is between approximately 0.010 and 0.020 inch (0.254-0.508 mm) in diameter. The diameter of the wire itself forming stainless steel coil 26 and coil 28 is approximately between 0.001 - 0.005 inch.
The distal end of secondary coil 28 is provided with a platinum soldered tip 30 to form a rounded and smooth termination to avoid puncturing the aneurysm or tearing tissue.
Although prebiased to form a cylindrical or conical envelope, secondary coil 28 is extremely soft and its overall shape is easily deformed. When inserted within the microcatheter (not shown), secondary coil 28 is easily straightened to lie axially within the microcatheter. Once 2~'~5~9, disposed out of the tip of the microcatheter, secondary coil 28 forms the shape shown in Figure 1 and may similarly be loosely deformed to the interior shape of the aneurysm.
As will be described below in greater detail in 5 connection with the third embodiment of Figure 3, after placement of secondary coil 28 within the interior of the aneurysm, a direct current is applied to guidewire 10 from a voltage source exterior to the body. The positive charge on secondary coil 28 within the cavity of the aneurysm causes a 10 thrombus to form within the aneurysm by electrothrombosis.
Detachment of the tip occurs either: (1) by continued application of current for a predetermined time when the portion 18 is exposed to blood: or (2) by movement of the wire to expose portion 18 to blood followed by continued 15 current application for a predeteremined time. Ultimately, both threadlike portion and stainless steel coil 26 will be completely disintegrated at least at one point, thereby allowing guidewire 10 to be withdrawn from the vascular space while leaving secondary coil 28 embedded within the thrombus formed within the aneurysm.
Figure 2 illustrates in enlarged partially cross-sectional view a second embodiment of the invention.
Stainless steel core 32 terminates in a conical distal portion 34. Stainless steel coil 36, shown in cross-sectional view, is soldered to distal portion 34 of guidewire 32 at bonding location 38. The opposing end of the stainless steel coil 36 is provided with a soldered, rounded platinum 2~~5~9w tip 40. In the illustrated embodiment, stainless steel core wire 32 is approximately 0.010 inch in diameter with the length of stainless steel coil 36 being approximately 8 cm.
with the longitudinal length of platinum tip 40 being between 3 and 10 mm. The total length of guidewire 32 from tip 40 to the proximate end is approximately 150 cm.
The embodiment of Figure 2 is utilized in exactly the same manner as described above in connection with Figure 1 to form a thrombic mass within an aneurysm or other vascular cavity. The embodiment of Figure 2 is distinguished from that shown in Figure 1 by the absence of the extension of stainless core 32 through coil 36 to tip 40. In the case of the embodiment of Figure 2 no inner core or reinforcement is provided within stainless steel coil 36. Threadlike portion 18 is provided in the embodiment of Figure 1 to allow increased tensile strength of the guidewire. However, a degree of flexibility of the guidewire is sacrificed by the inclusion even of threadlike tip 18, so that the embodiment of Figure 2 provides a more flexible tip, at least for that portion of the microguidewire constituting the stainless steel coil 36.
It is expressly understood that the helical secondary coil tip of the embodiment of Figure 1 could similarly be attached to stainless steel coil 36 of the embodiment of Figure 2 without departing from the spirit and scope of the invention.
17 i~~~ J.~ 9~
Thinned and threadlike portion guidewires disposed concentrically within coiled portions are well known and are shown in Antoshkiv, "Disposable Guidewire", U.S. Patent 3,789,841 (1974): 8epstxa et al., "Guidewire Device", U.S.
5 Patent 4,832,047 (1989): Engleson, "Catheter Guidewire", U.S.
Patent 4,884,579 (1989): Samson et al., "Guidewire for Catheters", U.S. Patent 4,538,622 (1985): and Samson et al., "Catheter Guidewire with Short Spring Tip and Method of Using the Same", U.S. Patent 4,554,929 (1985).
10 Turn now to the third embodiment of the invention as shown in Figure 3. Figure 3 shows an enlarged side view of a guidewire, generally denoted by reference numeral 42, disposed within a microcatheter 44 shown in cross-sectional view. Like the embodiment of Figure 1, a stainless steel 15 coil 46 is soldered to a conical portion 48 of guidewire 22 at a first bonding location 50. A thin threadlike extension 52 is then longitudinally disposed within stainless steel coil 46 to a second bonding location 54 where stainless steel guidewire 46 and threadlike portion 52 are soldered to a soft 20 platinum coil 56. Platinum coil 56 is not prebiased, nor does it contain any internal reinforcement, but is a free and open coil similar in that respect to stainless steel coil 36 of the embodiment of Figure 2.
However, platinum coil 56 is particularly distinguished 25 by its length of approximately 1 to 50 cm. and by its flexibility. The platinum or platinum alloy used is particularly pliable and the diameter of the wire used to F._ _ .,";J i~~ . . 18 n y'~,, - ' 1:' ~'~~,.
form platinum coil 56 is approximately 0.001 - 0.005 inch in diameter. The distal end of platinum coil 56 is provided with a smooth and rounded platinum tip 58 similar in that respect to tips 30 and 40 of Figures 1 and 2, respectively.
$ When coil 56 is disposed within microcatheter 54, it lies along the longitudinal lumen 60 defined by microcatheter 44. The distal end 62 of microcatheter 60 is then placed into the neck of the aneurysm and the guidewire 42 is advanced, thereby feeding tip 58 in platinum coil 56 into aneurysm 64 until bonding location 50 resides in the neck of the aneurysm as best depicted in the diagrammatic cross-sectional view of Figure 4.
Figure 4 illustrates the insertion of the embodiment of Figure 3 within a vessel 66 with distal tip of microcatheter 44 positioned near neck 68 of aneurysm 64. Coil 56 is fed into aneurysm 64 until at least a portion of stainless steel coil 46 is exposed beyond the distal tip 62 of microcatheter 44. A positive electric current of approximately 0.01 to 2 milliamps at 0.1 - 6 volts is applied to guidewire 42 to form the thrombus. Typically a thrombus will form within three to five minutes. The negative pole 72 of voltage source 70 is typically placed over and in contact with the skin.
After the thrombus has been formed and the aneurysm completely occluded, tip 58 and coil 56 are detached from guidewire 42 by electrolytic disintegration of at least one portion of stainless steel coil 46. In the illustrated embodiment this is accomplished by continued application of 19 2~~5%~9w .
current until the total time of current application is almost approximately four minutes.
At least one portion of stainless steel coil 46 will be completely dissolved through by electrolytic action within 3 to 10 minutes, usually about 4 minutes. After separation by electrolytic disintegration, guidewire 42, microcatheter 44 and the remaining portion of coil 46 still attached to guidewire 42 are removed from vessel 66, leaving aneurysm 64 completely occluded as diagrammatically depicted in Figure 5 by thrombus 74. It will be appreciated that the time of disintegration may be varied by altering the dimensions of the portions of the wire and/or the current.
The process is practiced under fluoroscopic control with local anesthesia at the groin. A transfemoral microcatheter is utilized to treat the cerebral aneurysm. The platinum is not affected by electrolysis and the remaining portions of the microcatheter are insulated either by a Teflon lamination directly on guidewire 42 and/or by microcatheter 44. Only the exposed portion of the guidewire 46 is affected by the electrolysis.
It has further been discovered that thrombus 74 continues to form even after detachment from guidewire 42.
It is believed that a positive charge is retained on or near coil 56 which therefore continues to attract platelets, white brood cells, red blood cells and fibrinogen within aneurysm 64.
_,~y2~~ i~9~
Many alterations and modifications may be made by those having ordinary skill in the art without departing from the spirit and scope of the invention. Therefore, it must be understood that the shape of the tip or distal platinum coil 5 used in combination with the guidewire according to the invention may be provided with a variety of shapes and envelopes. In addition thereto, the composition of the microguidewire tip may be made of elements other than platinum including stainless steel, beryllium, copper and 10 various alloys of the same with or without platinum. Still further, the diameter of the guidewire, various of the guidewire described above and the stainless steel coil immediately proximal to the detachable tip may be provided with differing diameters or cross sections to vary the times 15 and current magnitudes necessary in order to effectuate electrolytic detachment from the tip. Still further, the invention may include conventional electronics connected to the proximal end of the guidewire for determining the exact instant of detachment of the distal tip from the guidewire.
20 Therefore, the illustrated embodiment has been set forth only for the purposes of clarity and example and should not be taken as limiting the invention as defined by the following claims, which include all equivalent means whether now known or later devised.
Claims (101)
1. An apparatus for forming an occlusion within a body cavity having a fluid disposed therein comprising:
a guidewire adapted to be disposed near an opening into said body cavity;
a separable distal tip of said guidewire adapted for disposition into said body cavity to form said occlusion within said body cavity about said distal tip; and a detachable coupling between said distal tip and said guidewire characterized by nonoptically actuated detachability of said distal tip from said guidewire without necessarily displacing either said distal tip or said guidewire during detachment to leave said distal tip within said body cavity and said occlusion being formed within said body cavity, whereby said body cavity is occluded by said distal tip, and an occlusion is formed by use of said tip without necessarily altering desired placement of said distal tip during detachment or applying any force by said distal tip to any surface within said body cavity.
a guidewire adapted to be disposed near an opening into said body cavity;
a separable distal tip of said guidewire adapted for disposition into said body cavity to form said occlusion within said body cavity about said distal tip; and a detachable coupling between said distal tip and said guidewire characterized by nonoptically actuated detachability of said distal tip from said guidewire without necessarily displacing either said distal tip or said guidewire during detachment to leave said distal tip within said body cavity and said occlusion being formed within said body cavity, whereby said body cavity is occluded by said distal tip, and an occlusion is formed by use of said tip without necessarily altering desired placement of said distal tip during detachment or applying any force by said distal tip to any surface within said body cavity.
2. The apparatus of claim 1 where said distal tip has a length and flexibility to allow said distal tip to sufficiently fill said body cavity to impede flow of said fluid when said distal tip is disposed in said body cavity.
3. The apparatus of claim 1 where said coupling detaches by electrolytic detachment of said distal tip from said guidewire.
4. The apparatus of claim 3 where said coupling electrolytically detaches said distal tip from said guidewire by electrolytically disintegrating at least one portion of a connecting segment extending between said guidewire and said distal tip.
5. The apparatus of claim 4 where said coupling is a coil segment which is electrolytically disintegrated to effect detachment.
6. The apparatus of claim 5 where said coil segment is a stainless steel coil segment.
7. The apparatus of claim 1 further comprising a circuit for applying an electrical signal to said distal tip to form said occlusion by applying a positive direct current for a first predetermined time period.
8. The apparatus of claim 7 where said circuit applies a positive direct current to said distal tip for an additional predetermined time period separate from said first predetermined time period.
9. The apparatus of claim 7 further comprising a catheter in which said guidewire, distal tip and coupling are disposed, and where said coupling is not exposed to said fluid during said first predetermined time period by being disposed in said catheter to allow formation of said occlusion about said distal tip, and is exposed to said fluid during an additional predetermined time period to separate said distal tip from said guidewire.
10. The apparatus of claim 1 where said coupling is separated by applying a positive direct current to said distal tip for a predetermined time period.
11. The apparatus of claim 1 wherein said guidewire is adapted to be disposed in a first configuration relative to said body cavity so that a disintegratable portion of said tip remains insulated from said fluid during application of a first electrical signal to said tip, and where said disintegratable portion of said tip is adapted to assume to a second configuration where said disintegratable portion is exposed to said fluid when a second electrical signal is applied to said disintegratable portion to electrolytically dissolve said disintegratable portion in said fluid.
12. A guidewire for use in formation of an occlusion within a body cavity used in combination with a catheter comprising:
a core wire having at least an electrolyzable distal portion; and a separable elongate tip portion coupled to and extending from said core wire for a predetermined lineal extent, said separable elongate tip portion adapted to form said occlusion in said body cavity and being adapted for insertion within said body cavity, said separable elongate tip portion being resistant to electrolysis compared to said distal portion of said core wire, said separable elongate tip portion being selectively separated from said core wire: by electrolysis, whereby occlusion of said body cavity is achieved.
a core wire having at least an electrolyzable distal portion; and a separable elongate tip portion coupled to and extending from said core wire for a predetermined lineal extent, said separable elongate tip portion adapted to form said occlusion in said body cavity and being adapted for insertion within said body cavity, said separable elongate tip portion being resistant to electrolysis compared to said distal portion of said core wire, said separable elongate tip portion being selectively separated from said core wire: by electrolysis, whereby occlusion of said body cavity is achieved.
13. The guidewire of claim 12 wherein said distal portion of said core wire is an exposed stainless steel segment.
14. The guidewire of claim 13 wherein said stainless steel segment comprises a coil having a proximate and distal end, and connected at its proximate end to said core wire and connected at its distal end to said elongate tip portion of said guidewire.
15. The guidewire of claim 14 wherein said core wire is extended in a threadlike portion concentrically within said stainless steel coil from a proximal end of said stainless steel coil to where said stainless steel coil is connected to said elongate tip portion of said guidewire.
16. The guidewire of claim 14 wherein said coil defines an interior space, said interior space being free and unreinforced.
17. The guidewire of claim 12 wherein said separable elongate tip portion is a long and substantially flexible segment and is comprised of a metal not susceptible to electrolytic disintegration.
18. The guidewire of claim 17 wherein said long and flexible segment of said elongate tip portion has a length sufficient to substantially occupy said body cavity when inserted therein to substantially impede flow of fluid in said body cavity.
19. The guidewire of claim 12 wherein said separable elongate tip portion is comprised of platinum or platinum alloy.
20. A guidewire for use in formation of an occlusion used in combination with a catheter comprising:
an electrolyseable core wire; and a separable elongate tip portion extending said core wire for a predetermined lineal extent and coupled to said distal portion of said core wire, said separable elongate tip portion for insertion within a body cavity, said separable elongate tip portion not resistant to electrolytic disintegration in fluid as compared to said electrolyzable core wire, said separable elongate tip portion being separable from said core wire by electrolysis, wherein said separable elongate tip portion is a long and substantially flexible segment and is comprised of a metal not susceptible to electrolytic disintegration within fluid, and wherein said long and flexible segment is prebiased to form a helix when extended from said catheter, whereby occlusion of said body cavity is achievable.
an electrolyseable core wire; and a separable elongate tip portion extending said core wire for a predetermined lineal extent and coupled to said distal portion of said core wire, said separable elongate tip portion for insertion within a body cavity, said separable elongate tip portion not resistant to electrolytic disintegration in fluid as compared to said electrolyzable core wire, said separable elongate tip portion being separable from said core wire by electrolysis, wherein said separable elongate tip portion is a long and substantially flexible segment and is comprised of a metal not susceptible to electrolytic disintegration within fluid, and wherein said long and flexible segment is prebiased to form a helix when extended from said catheter, whereby occlusion of said body cavity is achievable.
21. The guidewire of claim 20 wherein said helix has a conical envelope.
22. The guidewire of claim 20 wherein said helix has a cylindrical envelope.
23. An apparatus adapted to form an occlusion within a body cavity having fluid disposed therein comprising:
a relaxed coil wire adapted for disposition near an opening into said body cavity, said relaxed coil wire having no substantial memory of its predisposed shape other than at most a relaxed, simple helical shape; and a separable distal tip of said coil wire adapted to be disposed into said body cavity to substantially space occupy said body cavity to mechanically form said occlusion within said body cavity about said separable distal tip; said separable distal tip being characterized as adapted to be nonthermally separated from said coil wire to leave said separable distal tip within said body cavity, wherein nonthermal separation is defined as a detachment without substantially increasing the temperature of said distal tip and wire, wherein said separable distal tip is separated from said coil wire without necessary displacement of said distal tip therefrom and without application of any force between said distal tip and said coil wire, whereby said body cavity is occluded by said distal tip, and any thrombus formed by use of said tip.
a relaxed coil wire adapted for disposition near an opening into said body cavity, said relaxed coil wire having no substantial memory of its predisposed shape other than at most a relaxed, simple helical shape; and a separable distal tip of said coil wire adapted to be disposed into said body cavity to substantially space occupy said body cavity to mechanically form said occlusion within said body cavity about said separable distal tip; said separable distal tip being characterized as adapted to be nonthermally separated from said coil wire to leave said separable distal tip within said body cavity, wherein nonthermal separation is defined as a detachment without substantially increasing the temperature of said distal tip and wire, wherein said separable distal tip is separated from said coil wire without necessary displacement of said distal tip therefrom and without application of any force between said distal tip and said coil wire, whereby said body cavity is occluded by said distal tip, and any thrombus formed by use of said tip.
24. The apparatus of claim 23 wherein said separable distal tip is mechanically detached from said coil wire.
25. The apparatus of claim 23 wherein said distal tip is sufficient long and flexible to fold upon itself a multiple number of times to occupy said body cavity to substantially impede fluid f7.ow therein.
26. A coil wire adapted to form an occlusion within a body cavity used in combination with a catheter comprising:
a separable detachable elongate distal tip coupled to and extending from said coil wire for a predetermined lineal extent and adapted to being packed into said body cavity to form said occlusion in said body cavity, said elongate distal tip portion being a relaxed coil having no substantial memory of its predisposed shape other than at most a relaxed, simple helical shape, whereby occlusion of said body cavity is achievable.
a separable detachable elongate distal tip coupled to and extending from said coil wire for a predetermined lineal extent and adapted to being packed into said body cavity to form said occlusion in said body cavity, said elongate distal tip portion being a relaxed coil having no substantial memory of its predisposed shape other than at most a relaxed, simple helical shape, whereby occlusion of said body cavity is achievable.
27. The coil wire of claim 26 wherein said elongate distal tip portion is a long and substantially pliable segment adapted to be multiply folded upon itself to sufficiently occupy said body cavity to impede fluid flow therein.
28. The coil wire of claim 26 where said core coil wire and distal tip are coupled by a polyester bead.
29. An improvement in a apparatus adapted to form an occlusion within a body cavity having fluid disposed therein comprising:
a deformable object disposable into said body cavity without tending to induce any preferred geometric form for said body cavity by such disposition, said object being flexible and shapeless, and having substantially no memory of its predisposed shape other than at most a relaxed, simple helical shape, said object being disposed into said body cavity to substantially impede movement of fluid in said body cavity and to thereby form said occlusion within said body cavity, whereby said body cavity is occluded by said body.
a deformable object disposable into said body cavity without tending to induce any preferred geometric form for said body cavity by such disposition, said object being flexible and shapeless, and having substantially no memory of its predisposed shape other than at most a relaxed, simple helical shape, said object being disposed into said body cavity to substantially impede movement of fluid in said body cavity and to thereby form said occlusion within said body cavity, whereby said body cavity is occluded by said body.
30. The improvement of claim 29 wherein said object is characterized as being packed said body cavity to substantially obstruct flow of fluid in said cavity.
31. The improvement of claim 30 where said object is packed into said cavity by disposition of a detachable, elongate, coil wire tip which is multiply folded upon itself in said body cavity.
32. A wire adapted to form an occlusion within a body cavity used in combination with a catheter comprising:
a coil wire;
a detachable elongate distal tip portion coupled to and extending from said coil wire for a predetermined lineal extent, said detachable elongate distal tip portion being adapted to being packed into said body cavity to form said occlusion in said body cavity, said distal tip portion including a first flexible, shapeless segment having substantially no memory of its predisposition shape other than at most a relaxed, simple helical shape for disposition into said cavity and a second segment for coupling said first portion to said coil wire, said second segment being adapted to be electrolyzed upon application of current; and an insulating coating disposed on said first segment, said second segment being left exposed to permit selective electrolysis thereof, whereby occlusion of said body cavity is achieved.
a coil wire;
a detachable elongate distal tip portion coupled to and extending from said coil wire for a predetermined lineal extent, said detachable elongate distal tip portion being adapted to being packed into said body cavity to form said occlusion in said body cavity, said distal tip portion including a first flexible, shapeless segment having substantially no memory of its predisposition shape other than at most a relaxed, simple helical shape for disposition into said cavity and a second segment for coupling said first portion to said coil wire, said second segment being adapted to be electrolyzed upon application of current; and an insulating coating disposed on said first segment, said second segment being left exposed to permit selective electrolysis thereof, whereby occlusion of said body cavity is achieved.
33. A apparatus adapted to form an occlusion within a body cavity having fluid disposed therein comprising:
a coil wire adapted for disposition near an opening into said body cavity;
a distal tip coupled to said coil wire adapted to substantially occupy said body cavity to form said occlusion within said body cavity about said distal tip, said distal tip being characterized by being adapted to carry electrical current therethrough to form an electrothrombosis in said body cavity, and being mechanically detachable from said coil wire to leave said distal tip within said body cavity, whereby said body cavity is occluded by said distal tip, and any thrombus formed by use of said distal tip.
a coil wire adapted for disposition near an opening into said body cavity;
a distal tip coupled to said coil wire adapted to substantially occupy said body cavity to form said occlusion within said body cavity about said distal tip, said distal tip being characterized by being adapted to carry electrical current therethrough to form an electrothrombosis in said body cavity, and being mechanically detachable from said coil wire to leave said distal tip within said body cavity, whereby said body cavity is occluded by said distal tip, and any thrombus formed by use of said distal tip.
34. A apparatus for forming an occlusion within a body cavity having fluid disposed therein;
a coil wire adapted for disposition near an opening into said body cavity;
a separable distal tip coupled to said coil wire adapted to substantially occupy said cavity to form said occlusion within said body cavity about said distal tip by application of a current to said distal tip which is packed into said cavity; said distal tip being mechanically detachable from said coil wire to leave said distal tip within said body cavity, whereby said body cavity is occluded by said distal tip, and any thrombus formed by use of said distal tip.
a coil wire adapted for disposition near an opening into said body cavity;
a separable distal tip coupled to said coil wire adapted to substantially occupy said cavity to form said occlusion within said body cavity about said distal tip by application of a current to said distal tip which is packed into said cavity; said distal tip being mechanically detachable from said coil wire to leave said distal tip within said body cavity, whereby said body cavity is occluded by said distal tip, and any thrombus formed by use of said distal tip.
35. A guidewire for use in combination with a catheter, said guidewire comprising:
a core wire having a main body and a distal portion;
and a detachable coil for insertion within a body cavity, said detachable coil being coupled to said main body via said distal portion and comprised of material not susceptible to electrolytic disintegration in blood;
wherein said distal portion is susceptible to electrolytic disintegration in blood whereby, on the application of electric current to the guidewire when said detachable coil is disposed in the body cavity, electrothrombosis being performed in the cavity by said detachable coil and at least one portion of said distal portion electrolytically disintegrated to detach said detachable coil from said main body to enable the removal of the main body of the core wire whilst leaving the detached coil within the body cavity.
a core wire having a main body and a distal portion;
and a detachable coil for insertion within a body cavity, said detachable coil being coupled to said main body via said distal portion and comprised of material not susceptible to electrolytic disintegration in blood;
wherein said distal portion is susceptible to electrolytic disintegration in blood whereby, on the application of electric current to the guidewire when said detachable coil is disposed in the body cavity, electrothrombosis being performed in the cavity by said detachable coil and at least one portion of said distal portion electrolytically disintegrated to detach said detachable coil from said main body to enable the removal of the main body of the core wire whilst leaving the detached coil within the body cavity.
36. A guidewire as claimed in claim 35, wherein said distal portion is exposed stainless steel.
37. A guidewire as claimed in claim 36, wherein said distal portion comprises a stainless steel coil connected at its proximal end to said core wire and connected at its distal end to said detachable coil.
38. A guidewire as claimed in claim 37, wherein said distal portion further comprises a threadlike extension of the main body of the core wire extending concentrically within said stainless steel coil and connected at its distal end to the connection of the distal end of the stainless steel coil and the detachable coil, both said threadlike extension and said stainless steel coil needing to be electrolytically disintegrated at least at one point in order to detach the detachable coil from the main body.
39. A guidewire as claimed in claim 37, wherein only one portion of said distal portion is required to be electrolytically disintegrated in order to detach said detachable coil from said main body.
40. A guidewire as claimed in claim 39, wherein said stainless steel coil defines an interior space, said interior space being free and unreinforced.
41. A guidewire as claimed in claim 35, wherein the detachable coil is a long and pliable segment.
42. A guidewire as claimed in claim 41, wherein said detachable coil has a length sufficient to substantially fill the body cavity when disposed therein.
43. A guidewire as claimed in claim 35, wherein the detachable coil is comprised of a metal not susceptible to electrolytic disintegration in blood.
44. A guidewire as claimed in claim 35, wherein the detachable coil does not contain any internal reinforcement.
45. A guidewire as claimed in claim 35, wherein the detachable coil is made of platinum or platinum alloy.
46. A guidewire as claimed in claim 35, wherein the detachable coil is prebiased to form a helix or spiral when advanced from a microcatheter into the body cavity.
47. A guidewire as claimed in claim 46, wherein the detachable coil is prebiased to have a conical envelope.
48. A guidewire as claimed in claim 46, wherein the detachable coil is prebiased to have a cylindrical envelope.
49. A guidewire as claimed in claim 46, wherein although prebiased the detachable coil is extremely soft and its overall shape is easily deformed such that, once advanced from a microcatheter into the body cavity, it will loosely deform to the interior shape of the body cavity.
50. A guidewire as claimed in claim 35, wherein the detachable coil is not prebiased.
51. A guidewire as claimed in claim 35, wherein the distal end of the detachable coil is provided with a platinum soldered tip to form a rounded and smooth termination to avoid puncturing the body cavity.
52. A guidewire as claimed in claim 35, wherein the main body of the core is covered with insulation to prevent the underlying portion of the guidewire from coming into contact with blood.
53. A guidewire as claimed in claim 35, further comprising a voltage source and means for enabling connection of the guidewire to the voltage source wherein the core wire is provided with means for enabling connection of the guidewire to a voltage source to enable electric current to be applied to the guidewire.
54. A catheter as claimed in claim 35 having disposed therein said guidewire.
55. An apparatus for forming an occlusion within a body cavity having an ionic fluid therein comprising:
a wire adapted to be disposed near an opening into said body cavity;
a separable distal tip of said wire adapted for disposition into said body cavity to form said occlusion within said body cavity about. said distal tip; and an electrolytically detachable connecting segment coupling said distal tip and said wire.
a wire adapted to be disposed near an opening into said body cavity;
a separable distal tip of said wire adapted for disposition into said body cavity to form said occlusion within said body cavity about. said distal tip; and an electrolytically detachable connecting segment coupling said distal tip and said wire.
56. The apparatus of claim 55 where said distal tip has a length and flexibility to allow said distal tip sufficiently to impede flow of said fluid in said body cavity when said distal tip is disposed in said body cavity.
57. The apparatus of claim 56 where said distal tip is comprised of a radio-opaque material and has a long and pliable length sufficient to cause said cavity to appear substantially opaque as determined by fluoroscopic examination.
58. The apparatus of claim 56 where said distal tip is comprised of a plurality of segments which collectively cause said cavity to appear substantially opaque as determined by fluoroscopic examination.
59. The apparatus of claim 55 where said connecting segment electrolytically detaches said distal tip from said wire by electrolytically disintegrating at least one portion of said connecting segment extending between said wire and said distal tip.
60. The apparatus of claim 58 where said connecting segment is a coil segment which is electrolytically disintegrated to effect detachment.
61. The apparatus of claim 55 further comprising a catheter into which said wire, distal tip and connecting segment are disposed, and where said connecting segment is retained with said catheter and not at first exposed to said fluid to allow formation of said occlusion about said distal tip, and is then subsequently extended out of said catheter and exposed to said fluid to separate said distal tip from said wire.
62. An apparatus for use in formation of an occlusion used in combination with a catheter comprising:
an electrolyzable core wire having a distal portion;
and a separable elongate tip portion extending said core wire and coupled to said distal portion of said core wire, said separable elongate tip portion for insertion within a body cavity, said separable elongate tip portion not resistant to electrolytic disintegration in fluid as compared to said electrolyzable core wire, and said separable elongate tip portion being detachable from said wire by electrolysis, wherein said separable elongate tip portion is a long and substantially flexible segment and is comprised of a metal not as susceptible to electrolytic disintegration within fluid as said core wire, and wherein said long and flexible segment is prebiased to form a helix when extended from said catheter.
an electrolyzable core wire having a distal portion;
and a separable elongate tip portion extending said core wire and coupled to said distal portion of said core wire, said separable elongate tip portion for insertion within a body cavity, said separable elongate tip portion not resistant to electrolytic disintegration in fluid as compared to said electrolyzable core wire, and said separable elongate tip portion being detachable from said wire by electrolysis, wherein said separable elongate tip portion is a long and substantially flexible segment and is comprised of a metal not as susceptible to electrolytic disintegration within fluid as said core wire, and wherein said long and flexible segment is prebiased to form a helix when extended from said catheter.
63. The apparatus of claim 62 wherein said helix has a conical envelope.
64 The apparatus of claim 62 wherein said helix has a cylindrical envelope.
65. An apparatus for use in formation of an occlusion within a body cavity comprising:
a wire having at least a electrolyzable distal portion; and a separable elongate tip portion of said wire coupled to and extending from said wire, said separable elongate tip portion adapted to form said occlusion in said body cavity and being adapted for insertion within said body cavity, said separable elongate tip portion being resistant to electrolysis compared to said distal portion of said core wire, said separable elongate tip portion being coupled to said wire by said electrolyzable distal portion.
a wire having at least a electrolyzable distal portion; and a separable elongate tip portion of said wire coupled to and extending from said wire, said separable elongate tip portion adapted to form said occlusion in said body cavity and being adapted for insertion within said body cavity, said separable elongate tip portion being resistant to electrolysis compared to said distal portion of said core wire, said separable elongate tip portion being coupled to said wire by said electrolyzable distal portion.
66. The apparatus of claim 65 further comprising a stainless steel segment which comprises a coil having a proximate and distal end and connected at its proximate end to said core wire and connected at its distal end to said elongate tip portion of said apparatus.
67. The apparatus of claim 65 wherein said coil defines an interior space, said interior space being free and unreinforced.
68. The apparatus of claim 65 wherein said separable elongate tip portion is a long and substantially flexible segment and is comprised of a metal not as susceptible to electrolytic disintegration as said core wire.
69. The apparatus of claim 68 wherein said long and flexible segment of said elongate tip portion has a length such that when disposed in said body cavity it assumes a form which substantially impedes flow of fluid in said body cavity.
70. An apparatus for forming an occlusion within a body cavity comprising:
a wire adapted to be disposed near an opening into said body cavity;
a separable distal tip of said wire adapted for disposition into said body cavity to form said occlusion within said body cavity about said distal tip; and a selectively detachable coupling between said distal tip and said wire characterized by detachment of said distal tip from said wire without necessarily displacing either said distal tip or said wire during detachment to leave said distal tip within said body cavity with said occlusion being formed within said body cavity, whereby said body cavity is occluded by said distal tip, and an occlusion is formed by use of said tip without necessarily altering desired placement of said distal tip during detachment or applying any force by said distal tip to any surface within said body cavity by reason of said detachment.
a wire adapted to be disposed near an opening into said body cavity;
a separable distal tip of said wire adapted for disposition into said body cavity to form said occlusion within said body cavity about said distal tip; and a selectively detachable coupling between said distal tip and said wire characterized by detachment of said distal tip from said wire without necessarily displacing either said distal tip or said wire during detachment to leave said distal tip within said body cavity with said occlusion being formed within said body cavity, whereby said body cavity is occluded by said distal tip, and an occlusion is formed by use of said tip without necessarily altering desired placement of said distal tip during detachment or applying any force by said distal tip to any surface within said body cavity by reason of said detachment.
71. The apparatus of claim 70 where said distal tip has a length and flexibility to allow said distal tip sufficiently to fill said body cavity to impede flow of a fluid in said body cavity when said distal tip is disposed in said body cavity.
72. The apparatus of claim 71 where said distal tip has a long and pliable length sufficient to fill said cavity.
73. The apparatus of claim 70 where said coupling detaches by electrolytic detachment of said distal tip from said wire.
74. The apparatus of claim 73 where said coupling electrolytically detaches said distal tip from said wire by electrolytically disintegrating at least one portion of a connecting segment extending between said wire and said distal tip.
75. The apparatus of claim 74 where said coupling is a coil segment which is electrolytically disintegrated to effect detachment.
76. The apparatus of claim 75 where said coil segment is a stainless steel coil segment.
77. The apparatus of claim 70 further comprising a circuit for applying an electrical signal to said distal tip to form said occlusion by applying a positive direct current for a first predetermined time period.
78. The apparatus of claim 77 where said circuit applies a positive direct current to said distal tip for an additional predetermined time period separate from said first predetermined time period.
79. The apparatus of claim 77 further comprising a catheter in which said wire, distal tip and coupling are disposed, and where said coupling is not exposed to said fluid during said first predetermined time period by being disposed within said catheter to allow formation of said occlusion about said distal tip, and is exposed to said fluid during an additional predetermined time period to separate said distal tip from said wire by being disposed outside of said catheter.
80. The apparatus of claim 70 where said distal tip is detached from said wire by applying a positive direct current to said distal tip for a predetermined time period.
81. The apparatus of claim 70 wherein said wire is adapted to be disposed in a first configuration relative to said body cavity so that a disintegratable portion of said tip remains insulated from said fluid during application of a first electrical signal to said tip, and where said disintegratable portion of said tip is adapted to assume to a second configuration where said disintegratable portion is exposed to said fluid when a second electrical signal is applied to said disintegratable portion to electrolytically dissolve said disintegratable portion in said fluid.
82. An apparatus for use in formation of an occlusion within a body cavity comprising:
a wire having at least a electrolyzable distal portion; and a separable elongate tip portion of said wire coupled to and extending from said wire, said separable elongate tip portion adapted to form said occlusion in said body cavity and being adapted for insertion within said body cavity, said separable elongate tip portion being resistant to electrolysis compared to said distal portion of said core wire, said separable elongate tip portion being coupled to said wire by said electrolyzable distal portion, whereby occlusion of said body cavity is achieved.
a wire having at least a electrolyzable distal portion; and a separable elongate tip portion of said wire coupled to and extending from said wire, said separable elongate tip portion adapted to form said occlusion in said body cavity and being adapted for insertion within said body cavity, said separable elongate tip portion being resistant to electrolysis compared to said distal portion of said core wire, said separable elongate tip portion being coupled to said wire by said electrolyzable distal portion, whereby occlusion of said body cavity is achieved.
83. The apparatus of claim 82 wherein said distal portion of said core wire is an exposed stainless steel segment.
84. The apparatus of claim 82 wherein said stainless steel segment comprises a coil having a proximate and distal end and is connected at its proximate end to said core wire and connected at its distal end to said elongate tip portion of said apparatus.
85. The apparatus of claim 82 wherein said core wire is extended in a threadlike portion concentrically within said stainless steel coil from a proximal end of said stainless steel coil to where said stainless steel coil is connected to said elongate tip portion of said apparatus.
86. The apparatus of claim 82 wherein said coil defines an interior space, said interior space being free and unreinforced.
87. The apparatus of claim 82 wherein said separable elongate tip portion is a long and substantially flexible segment and is comprised of a metal not as susceptible to electrolytic disintegration as said core wire.
88. The apparatus of claim 87 wherein said long and flexible segment of said elongate tip portion has a length and sufficient to substantially occupy said body cavity when inserted therein to substantially impede flow of fluid in said body cavity.
89. The apparatus of claim 82 wherein said separable elongate tip portion is comprised of platinum or platinum alloy.
90. An apparatus for use in formation of an occlusion used in combination with a catheter comprising:
an electrolyzable core wire; and a separable elongate tip portion extending said core wire for a predetermined lineal extent and coupled to said distal portion of said core wire, said separable elongate tip portion for insertion within a body cavity, said separable elongate tip portion not resistant to electrolytic disintegration in fluid as compared to said electrolyzable core wire, said separable elongate tip portion being separable from said core wire by electrolysis, wherein said separable elongate tip portion is a long and substantially flexible segment and is comprised of a metal not as susceptible to electrolytic disintegration within fluid as said core wire, and wherein said long and flexible segment is prebiased to form a helix when extended from said catheter, whereby occlusion of said body cavity is achieved.
an electrolyzable core wire; and a separable elongate tip portion extending said core wire for a predetermined lineal extent and coupled to said distal portion of said core wire, said separable elongate tip portion for insertion within a body cavity, said separable elongate tip portion not resistant to electrolytic disintegration in fluid as compared to said electrolyzable core wire, said separable elongate tip portion being separable from said core wire by electrolysis, wherein said separable elongate tip portion is a long and substantially flexible segment and is comprised of a metal not as susceptible to electrolytic disintegration within fluid as said core wire, and wherein said long and flexible segment is prebiased to form a helix when extended from said catheter, whereby occlusion of said body cavity is achieved.
91. The apparatus of claim 90 wherein said helix has a conical envelope.
92. The apparatus of claim 90 wherein said helix has a cylindrical envelope.
93. An apparatus for use in forming an occlusion within a body cavity having an ionic fluid therein having a separable distal tip of a wire disposable into said body cavity to form said occlusion within said body cavity about said distal tip and characterized in that said distal tip is electrolytically detachable from said wire to leave said distal tip within said body cavity with said occlusion being formed within said body cavity.
94. The apparatus of claim 93 where said distal tip of said wire when disposed into said body cavity occupies said cavity to a degree sufficient to impede low of a fluid in said body cavity.
95. The apparatus of claim 94 where said distal tip of said wire has a long and pliable length for disposition into said body cavity.
96. The apparatus of claim 93 where said distal tip of said wire is detached by electrolytically disintegrating a connecting coupling between said wire and said distal tip to effect separation.
97. The apparatus of claim 96 further comprising a movable catheter shielding about said coupling between said wire and distal tip from said fluid when said coupling in said catheter to allow formation of said occlusion about said distal tip, and then which coupling is then exposed to said fluid to electrolytically separate said distal tip from said wire.
98. The apparatus of claim 93 in which a wire, is repeatedly disposed with a separable distal tip, and electrolytically detached said distal tip, so that a plurality of said distal tips are separated and disposed in said body cavity to collectively form an occlusion in said body cavity.
99. An apparatus for use with a catheter to form an occlusion comprising an electrolyzable core wire disposable near the situs of said occlusion, a separable elongate tip portion extending from and coupled to said core wire disposable at said situs of said occlusion, characterized by said separable elongate tip portion being more resistant to electrolytic disintegration in fluid than said electrolyzable core wire, and being a long and substantially flexible segment prebiased to form a helix when extended from said catheter; and having an elongate tip portion from said core wire detachable by electrolysis.
100. The apparatus of claim 99 where said separable elongate tip portion has a helix with a cylindrical envelope.
101. The apparatus of 99 where said separable elongate tip portion has a helix with a conical envelope.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US07/492,717 US5122136A (en) | 1990-03-13 | 1990-03-13 | Endovascular electrolytically detachable guidewire tip for the electroformation of thrombus in arteries, veins, aneurysms, vascular malformations and arteriovenous fistulas |
US492,717 | 1990-03-13 | ||
PCT/US1991/000057 WO1991013592A1 (en) | 1990-03-13 | 1991-01-03 | Endovascular electrolytically detachable guidewire tip |
Publications (2)
Publication Number | Publication Date |
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CA2055492A1 CA2055492A1 (en) | 1991-09-14 |
CA2055492C true CA2055492C (en) | 2000-11-14 |
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Application Number | Title | Priority Date | Filing Date |
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CA002055492A Expired - Lifetime CA2055492C (en) | 1990-03-13 | 1991-01-03 | Endovascular electrolytically detachable guidewire tip |
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US (5) | US5122136A (en) |
EP (6) | EP1329196B1 (en) |
JP (1) | JP2501389B2 (en) |
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AT (5) | ATE431722T1 (en) |
AU (1) | AU636217B2 (en) |
CA (1) | CA2055492C (en) |
DE (7) | DE69133297T2 (en) |
DK (3) | DK0484468T4 (en) |
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FI (1) | FI915332A0 (en) |
GR (1) | GR980300008T1 (en) |
HU (1) | HU219694B (en) |
WO (1) | WO1991013592A1 (en) |
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
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- 1991-01-03 DE DE69131466T patent/DE69131466T2/en not_active Expired - Lifetime
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- 1991-01-03 DE DE0484468T patent/DE484468T1/en active Pending
- 1991-01-03 EP EP97111110A patent/EP0804904A1/en not_active Ceased
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- 1991-11-12 KR KR1019910701607A patent/KR100200441B1/en not_active IP Right Cessation
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1997
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1998
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Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
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USRE41029E1 (en) | 1990-03-13 | 2009-12-01 | The Regents Of The University Of California | Endovascular electrolytically detachable wire and tip for the formation of thrombus in arteries, veins, aneurysms, vascular malformations and arteriovenous fistulas |
USRE42625E1 (en) | 1990-03-13 | 2011-08-16 | The Regents Of The University Of California | Endovascular electrolytically detachable wire and tip for the formation of thrombus in arteries, veins, aneurysms, vascular malformations and arteriovenous fistulas |
USRE42662E1 (en) | 1990-03-13 | 2011-08-30 | The Regents Of The University Of California | Endovascular electrolytically detachable wire and tip for the formation of thrombus in arteries, veins, aneurysms, vascular malformations and arteriovenous fistulas |
USRE42756E1 (en) | 1990-03-13 | 2011-09-27 | The Regents Of The University Of California | Endovascular electrolytically detachable wire and tip for the formation of thrombus in arteries, veins, aneurysms, vascular malformations and arteriovenous fistulas |
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