CA2232186C - Catheter deliverable thrombogenic apparatus and method - Google Patents

Catheter deliverable thrombogenic apparatus and method Download PDF

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Publication number
CA2232186C
CA2232186C CA002232186A CA2232186A CA2232186C CA 2232186 C CA2232186 C CA 2232186C CA 002232186 A CA002232186 A CA 002232186A CA 2232186 A CA2232186 A CA 2232186A CA 2232186 C CA2232186 C CA 2232186C
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CA
Canada
Prior art keywords
wire
cuts
catheter
target location
occupy
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 - Fee Related
Application number
CA002232186A
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French (fr)
Other versions
CA2232186A1 (en
Inventor
Stephen C. Jacobsen
Clark C. Davis
John A. Lippert
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Precision Vascular Systems Inc
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Precision Vascular Systems Inc
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Filing date
Publication date
Application filed by Precision Vascular Systems Inc filed Critical Precision Vascular Systems Inc
Publication of CA2232186A1 publication Critical patent/CA2232186A1/en
Application granted granted Critical
Publication of CA2232186C publication Critical patent/CA2232186C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/01—Filters implantable into blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/1214—Coils or wires
    • A61B17/1215—Coils or wires comprising additional materials, e.g. thrombogenic, having filaments, having fibers, being coated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12163—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a string of elements connected to each other
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • A61B17/12172—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure having a pre-set deployed three-dimensional shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • A61B17/12177—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure comprising additional materials, e.g. thrombogenic, having filaments, having fibers or being coated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/01—Filters implantable into blood vessels
    • A61F2002/016—Filters implantable into blood vessels made from wire-like elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004—Rounded shapes, e.g. with rounded corners
    • A61F2230/0006—Rounded shapes, e.g. with rounded corners circular
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0091—Three-dimensional shapes helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section

Abstract

A catheter deliverable thrombogenic device includes a catheter for threading into a body vasculature passageway to a target location, and a resilient wire element coiled and shaped to occupy a certain volume when unconstrained, and to straighten when inserted lengthwise into and constrained by the catheter, for ultimate discharge therefrom to expand and occupy the target location. The wire element includes a plurality of cuts on the exterior surface thereof at selected locations to increase the flexibility of the wire element.

Description

CATHETER DELIVERABLE THROMBOGENIC
APPARATUS AND METHOD
BACKGROUND OF THE INVENTION
This invention relates to vaso-occlusive devices for arresting blood flow in body vasculature or cavities.
Devices which ~~cclude blood flow and/or initiate blood clotting, and which can be introduced into the body via a catheter or other cannula are valuable for stopping bleeding or the threat of bleeding, cutting off blood supply to a diseased organ, reducing blood flow to an organ, rebuilding a defective organ, etc. Devices typically utilized are coils or particles which are deployed through a catheter to a target site where arresting blood flow is desired. In addition, various solutions may be delivered through the catheter either for assisting and accE~lerating clotting or in treating the medical problem.
Typical devices used in the past include platinum coils which were inserted into the catheters and then pushed therethrough to the target site using a conventional.
catheter guide wired or other device as a "plunger". The coil devices are preset in a desire shape, typically a simple helix, so that after they are delivered to the desired site, they resume their original shape. Prior art platinum coil devices have often been ineffective in holding their positions at the delivered site, and thus ineffective in occ7_uding at the site. Types of particles u~;ed in the past for occluding blood flow include PVA or hydrophilic particles that swell to a larger size when blood is absorbed.. This swelling, of course, aids in stopping the flow of blood, assuming the positions of the particles are maintained.
The prior art approaches for arresting blood flow are fairly rudimentary and only partially successful in achieving the desired blood flow stoppage.
SUi~~ARY OF THE INVENTION
It is an objet- of the invention to provide new and improved vaso-occlusive devices which may be easily deployed to a target site in the human body and which are effective in inducing clotting or otherwise arresting blood flow.
It is also an object of the invention to provide such devices which are easily manufactured and which can be tailor- made in size and configuration to accommodate the targeted deployment: location.
It is a further object of the invention to provide such devices which may be quickly and easily deployed to a target location in the body, and remain in place.
The above anti other objects of the invention are realized in a specific illustrative embodiment of a thrombogenic apparatus which includes a catheter for threading into a body vasculature passageway to a target location, and a wire element coiled and shaped to occupy a certain volume when unconstrained, and to straighten when inserted lengthwise into and constrained by the catheter, for ultimate discharge therefrom to expand and occupy the target location.
In accordance with one aspect of the invention, the wire element is formed to have a coil diameter which becomes gradually smaller toward a distal end. In accordance with another aspect of the invention, the smaller diameter coils near and at the distal end are tightly wound to inhibit flow of blood therepast, when inserted into a blood vessel.
The wire element may be a single solid wire or a tubular wire.
To control flexibility and "holding strength" of the wire element in a vessel, especially at the distal end, cuts may be formed on the exterior of the wire element and spaced- and width- and depth-controlled to achieve the flexibility and shape desired.
According to an aspect of the present invention, there is provided thrombogenic apparatus comprising a catheter for threading into a body vasculature passageway to a target location, and a resilient wire means shaped to occupy a certain volume when unconstrained, and to straighten when inserted lengthwise into and constrained by the catheter, for ultimate discharge therefrom to expand and occupy the target location, said wire means formed into a coil and including a plurality of cuts on the exterior surface thereof at selected locations, to increase the flexibility of the wire means.
According to another aspect of the present invention, there is provided a thrombogenic apparatus comprising a catheter for threading into a body vasculature passageway to a target location, and a resilient, tubular wire having sidewalk surrounding a central hollow shaped to occupy a certain volume when unconstrained, and to straighten when inserted lengthwise into and constrained by the catheter, for ultimate discharge therefrom to expand and occupy the target location, said resilient, tubular wire including a plurality of cuts on the exterior surface thereof at selected locations, to increase the flexibility of said wire.
According to still another aspect of the present invention, there is provided thrombogenic apparatus comprising a catheter for threading into a body vasculature passageway to a target location, and a resilient wire coiled and shaped to occupy a certain volume when unconstrained, and to straighten when inserted lengthwise into and constrained by the catheter, for discharge therefrom to expand and occupy the target location, said wire formed to have a coil diameter which becomes gradually smaller toward a distal end and having a plurality of cuts on an exterior surface thereof.
BRIEF DESCRIPTION OF THE DRAWINGS
The above and other objects, features and advantages of.the invention will become apparent from a consideration of the following detailed description presented in connection with the accompanying drawings in which:
FIG. 1A is a side, fragmented, cross-sectional view of a thrombogenic, coiled-wire device made in accordance with the principles of the present invention;
FIG. 1B is a front end view of the wire coil of FIG. 1A, taken along lines 1B--1B;
FIG. 2 is a side, fragmented, cross-sectional view of a coil-wire device made in accordance with the principles of the present invention, shown partially disposed in a catheter;
FIG. 3 is a side, fragmented view of still another embodiment of a coiled-wire device made in accordance with the principles of the present invention.

4a DETAILED DESCRIPTION
Referring to FIG. 1A and 1B, there is shown a side, cross-sectional, fragmented view and an end view respectively of a resilient wire 4 which has been formed into a coil. In FIG. 1A, the wire 4 is shown disposed in a blood vessel 8. The wire 4 includes a larger diameter section 4a and a gradually narrowing section 4b. The coils in the larger diameter section 4a expand to contact the walls of the blood vessel 8 to hold the coil wire 4 in place. The narrower diameter section 4b serves as the leading or distal end of the coil wire 4 and preferably is more flexible to minimize damage or trauma to vessel walls when inserting the coil wire (to be discussed momentarily).
The flexibility and shape of the coil wire 4 may be controlled by appropriate placement of cuts 9 on the exterior surface (such as shown at 10 in enlarged view in FIG. 1). By appropriate spacing of the cuts both circumferentially and longitudinally and by varying the depth and width of the cuts, desired flexibility and shape can be achieved. For example, generally spacing the cuts closer together and making them wider and deeper provides greater flexibility and vice versa. Cuts in the wire 4 also enhance the wire's thrombogenicity, and provide sites for holding clotting agents or other drugs to be deposited in the blood vessel.
The wire 4 might, for example, be formed of a highly elastic nickel-titanium alloy wire with directionally specific cuts and having an outside diameter of about .008 inch to .060 inch. The diameter of the larger diameter section 4a advantageously is from about 3 to 12 mm whereas the diameter of the smallest diameter coil in section 4b 4b advantageously is from about 1 to 2 mm, both calculated when the coil wire 4 is unconstrained.
Tapering the diameter of the wire coil 4 as in section 4b provides a greater barrier and density (of occlusion wires) to the flow of blood, and thus greater ability to occlude, as best seen in the FIG. 1B view, taken along lines 1B--1B of FIG.. 1A. (Controlling the tapering of [and spacing between] coals allows use of the coil as a limited 5 leak valve or a complete block.
The coil wire 4 may either be a solid wire or a tubular wire, of the general dimensions discussed above.
If tubular, and formed with cuts on the exterior surface, same of those cuts. could be made to extend through the tubular walls to the interior and then medication placed in the hollow of the tube to gradually leak from the cuts after the coil wire were put in position at the target site. In this manner, the thrombogenic function of the coil wire 4 is augmented by a medication delivery function.
Also, thrombogenic fibers could be disposed in the hollow of a tubular wire t:o enhance occlusion and clotting.
FIG. 2 shows a side, fragmented, cross-sectional view of a wire coil 4 partially disposed in a catheter 12. For deployment of the coil wire 4 to a target location in a va.sculature passag~=way or other cavity in the body, the wire 4 may be threaded into the catheter 12 generally straight as shown in FIG. 2, and then pushed through the catheter by anothE:r guide wire (not shown) or similar device which serves as a type of plunger to force the coil wire out the distal end of the catheter where it then e~:pands to seat itself at the target location. When deployed to a targE:t site in the body past which blood is flowing, the wire coil 4 serves to slow the flow to allow for coagulation or allotting and ultimately the arresting of further flow. To aid in the clotting process, clotting agents, in the form of a solution, might be delivered th rough the catheter 12 along with the deployment of the coil wire 4, to t:he target site. Alternatively, such solution could be disposed in a tubular wire coil 4 to gradually leak from the tube through side cuts which extend through the tubular walls, as previously discussed above.
The embodimeni~ of the wire coil 4 shown in FIG. 2 includes a narrowed distal section 4b in which the coils are tightly wound to the extent that the adjacent coils touch. With such high density packing of the coils, the flow of blood i~~ substantially stopped even before coagulation or clotting takes place.
FIG. 3 shows a side, fragmented view of a wire 32 having cuts 36 formed in the exterior surface thereof. The wire 32 could be Either solid or tubular, and would be formed into a coil having a tapered distal end, such as shown in FIG. 1A. 'L'he cuts 36 would be placed, as earlier described, to control the flexibility and shape along the length of the wire. These cuts could be formed either by saw cutting or thref=_-dimensional etching such as described in U.S. Patent No. 5,106,455.
Radiopaque bands 40 may be wrapped about the wire 32 at predetermined locations along the length thereof to allow tracking movement of the wire in a vasculature passageway in the body. Thrombogenic fibers 44 made, for example, of DacronC> or other polymers are attached to the wire 32 at certain locations, preferably where cuts have been made. The fibers 44 could be tied into the wire 32, attached by an adhesive, fused or other well-known bonding method. These fibers promote the clotting and coagulation of blood flowing past the wire 32 which, of course, is the desired result.
It is to be understood that the above-described arrangements are only illustrative of the application of the principles of the present invention. Numerous modifications and alternative arrangements may be devised b~~ those skilled in the art without departing from the s~?irit and scope of the present invention and the appended c:Laims are intended to cover such modifications and arrangements .

Claims (20)

1. Thrombogenic apparatus comprising a catheter for threading into a body vasculature passageway to a target location, and a resilient wire means shaped to occupy a certain volume when unconstrained, and to straighten when inserted lengthwise into and constrained by the catheter, for ultimate discharge therefrom to expand and occupy the target location, said wire means formed into a coil and including a plurality of cuts on the exterior surface thereof at selected locations, to increase the flexibility of the wire means.
2. An apparatus as in claim 1 wherein said coil has a diameter which becomes gradually smaller toward a distal end.
3. An apparatus as in claim 2 wherein the smaller diameter coils near and at the distal end are tightly wound to inhibit flow of blood therepast, when inserted into a blood vessel.
4. An apparatus as in claim 2 wherein the coil diameter at a proximal end is from about 3 to 12 millimeters, and wherein the coil diameter at the distal end is from about 1 to 3 millimeters.
5. An apparatus as in claim 1 wherein said wire includes more cuts per unit length near the distal end than at other locations, such that the distal end is more flexible.
6. An apparatus as in claim 1 further comprising lengths of fiber disposed in the cuts to extend outwardly of the wire to assist in thrombosis.
7. An apparatus as in claim 6 wherein the fibers are made of material selected from the group consisting of dacron and silk.
8. An apparatus as in claim 1 wherein said wire is solid.
9. An apparatus as in claim 1 wherein said wire means is made of an alloy of nickel and titanium.
10. An apparatus as in claim 9 wherein said wire means has a diameter of from about 0.008 to 0.060 inches.
11. A thrombogenic apparatus comprising a catheter for threading into a body vasculature passageway to a target location, and a resilient, tubular wire having sidewalls surrounding a central hollow shaped to occupy a certain volume when unconstrained, and to straighten when inserted lengthwise into and constrained by the catheter, for ultimate discharge therefrom to expand and occupy the target location, said resilient, tubular wire including a plurality of cuts on the exterior surface thereof at selected locations, to increase the flexibility of said wire.
12. An apparatus as in claim 11 wherein at least some of said cuts extend through the sidewalls to the central hollow.
13. An apparatus as in claim 12 further including medication disposed in the central hollow for leaking sidewalls, when the apparatus is placed at the target location.
14. An apparatus as in claim 11 further including fiber disposed in the hollow of the wire to assist in thrombosis.
15. Thrombogenic apparatus comprising a catheter for threading into a body vasculature passageway to a target location, and a resilient wire coiled and shaped to occupy a certain volume when unconstrained, and to straighten when inserted lengthwise into and constrained by the catheter, for discharge therefrom to expand and occupy the target location, said wire formed to have a coil diameter which becomes gradually smaller toward a distal end and having a plurality of cuts on an exterior surface thereof.
16. Apparatus as in claim 15 wherein the smaller diameter coils near and at the distal end are tightly wound to inhibit flow of blood therepast when inserted into a blood vessel.
17. Apparatus as in claim 15 wherein said wire is solid.
18. Apparatus as in claim 15 wherein said wire is tubular having sidewalls surrounding a central hollow.
19. Apparatus as in claim 18 wherein at least some of said plurality of cuts extend through the sidewalls to the central hollow.
20. Apparatus as in claim 19 further including medication disposed in the central hollow for leaking therefrom through the cuts which extend through the sidewalls, when the apparatus is placed at the target location.
CA002232186A 1997-03-17 1998-03-16 Catheter deliverable thrombogenic apparatus and method Expired - Fee Related CA2232186C (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US08/819,611 1997-03-17
US08/819,611 US5911717A (en) 1997-03-17 1997-03-17 Catheter deliverable thrombogenic apparatus and method

Publications (2)

Publication Number Publication Date
CA2232186A1 CA2232186A1 (en) 1998-09-17
CA2232186C true CA2232186C (en) 2006-05-16

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CA002232186A Expired - Fee Related CA2232186C (en) 1997-03-17 1998-03-16 Catheter deliverable thrombogenic apparatus and method

Country Status (10)

Country Link
US (1) US5911717A (en)
EP (1) EP0865772B1 (en)
JP (1) JP3325828B2 (en)
KR (1) KR19980080321A (en)
CN (1) CN1244375A (en)
AT (1) ATE306872T1 (en)
AU (1) AU5933298A (en)
CA (1) CA2232186C (en)
DE (1) DE69831889T2 (en)
TW (1) TW387803B (en)

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CA2232186A1 (en) 1998-09-17
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US5911717A (en) 1999-06-15
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TW387803B (en) 2000-04-21
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KR19980080321A (en) 1998-11-25
JP3325828B2 (en) 2002-09-17
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JPH10305039A (en) 1998-11-17
CN1244375A (en) 2000-02-16

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