US20040098024A1 - Containers and methods for delivering vaso-occluding filaments and particles - Google Patents

Containers and methods for delivering vaso-occluding filaments and particles Download PDF

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US20040098024A1
US20040098024A1 US10/400,185 US40018503A US2004098024A1 US 20040098024 A1 US20040098024 A1 US 20040098024A1 US 40018503 A US40018503 A US 40018503A US 2004098024 A1 US2004098024 A1 US 2004098024A1
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Prior art keywords
container
kit
vaso
delivery
method
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Abandoned
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US10/400,185
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Martin Dieck
Ryan Pierce
Richard Helkowski
John Miller
Ivan Sepetka
Ron French
Kristen Valley
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Concentric Medical Inc
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Concentric Medical Inc
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Priority to US10/106,483 priority Critical patent/US6953465B2/en
Application filed by Concentric Medical Inc filed Critical Concentric Medical Inc
Priority to US10/400,185 priority patent/US20040098024A1/en
Assigned to CONCENTRIC MEDICAL, INC. reassignment CONCENTRIC MEDICAL, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: DIECK, MARTIN S., FRENCH, RON, MILLER, JOHN, PIERCE, RYAN K., SEPETKA, IVAN, VALLEY, KIRSTEN, HELKOWSKI, RICHARD A.
Publication of US20040098024A1 publication Critical patent/US20040098024A1/en
Application status is Abandoned legal-status Critical

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12181Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices
    • A61B17/1219Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices expandable in contact with liquids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • A61B17/12113Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12181Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices
    • A61B17/12186Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices liquid materials adapted to be injected
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B50/30Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205Introduction devices

Abstract

Containers for holding and delivering vaso-occluding materials, such as hydrogel particles and filaments include a fluid inlet port and a fluid outlet port that are respectively fluidly connectable with a fluid source and a delivery catheter. The vaso-occlusive materials may be held in the container in a hydrated or unhydrated state. The container further includes at least one chamber or passageway extending therebetween. The passageway may be straight, curved, spiral, helical, narrow or otherwise shaped. The chamber may also have sections of varying cross section such as a ramped section. The shapes of the passageways of the container help organize ejection of the vaso-occluding materials minimizing contamination and clumping.

Description

    CROSS REFERENCE
  • This application is a continuation-in-part of application Ser. No. 10/106,483 (atty. docket no. 21186-000400US), filed on Mar. 25, 2002, the full disclosure of which is incorporated herein by reference.[0001]
  • BACKGROUND OF THE INVENTION
  • 1. Field of the Invention. [0002]
  • The present application is directed generally at medical devices and methods and, more particularly, containers and methods for holding and delivering vaso-occluding filaments and particles. [0003]
  • Numerous persons experience some form of hemorrhagic stroke or blood vessel rupture in the brain. Ruptures can occur with a number of abnormalities including arterio venous malformations (AVM), aneurysms (a ballooning of the arterial wall), fistulas, or a burst blood vessel. Additionally, abnormal vasculature is generated in the process of tumor growth requiring larger than normal blood flow to sustain the tumor. [0004]
  • Endovascular therapies for treating vessel ruptures and blood flow abnormalities include implanting vaso-occlusive agents, coils and other devices such as that described in U.S. Pat. No. 4,994,069, and injecting hydrogel vaso-occluding particles and filaments into the vessels to be treated, as described in U.S. Patent Application Publication Nos. 2002/0193813A1; 2003/004533A1; 2003/0004568A1; and 2002/0193812A1, each of which are assigned to the assignee of the present application and are hereby incorporated by reference in their entirety. [0005]
  • Injecting vaso-occluding materials, however, requires careful handling in order to avoid various problems. For example, the particles and filaments may clump and clog the lumens and openings of the dispensing containers and instruments. The small size of the particles and filaments makes them inconvenient for a doctor to handle. In particular, capturing/collecting a filament in a solution is difficult due to their small size. The vaso-occluding material may be contaminated during the mixing or transporting step. The vaso-occluding materials may become damaged during shipping and storing. For example, when hydrogel filaments are shipped in an unhydrated state, they tend to be brittle. Such filaments are particularly vulnerable to breaking during shipping. [0006]
  • For these reasons, it would be desirable to provide improved apparatus and methods for delivering vaso-occluding elements, particularly hydratable particles and filaments. The apparatus and methods should avoid clumping and tangling of the vaso-occluding elements prior to and during delivery and should further avoid clogging of the delivery apparatus during delivery. In particular, the methods and apparatus should in at least some instances permit delivery of individual vaso-occluding elements singly, i.e. one at a time. The apparatus and methods should also facilitate and improve the collection and storage of the vaso-occluding elements prior to use. It would be further desirable to provide for storage of the vaso-occluding elements in either a hydrated or non-hydrated condition and, in the latter case, permit convenient hydration in the storage container prior to use. In all cases, it would be desirable that the stored vaso-occluding elements be protected during storage and shipment. At least some of these objectives will be met by the invention described hereinafter. [0007]
  • BRIEF SUMMARY OF THE INVENTION
  • Described herein are kits, containers and methods for holding and delivering vaso-occluding elements, including both filaments and particles. In one variation, the kit comprises a plurality of hydratable vaso-occluding elements and a container holding the hydratable vaso-occluding elements. The container has an inlet port and an outlet port. At least one of the fluid inlet and outlet ports is adapted to fluidly connect with a fluid source, typically a pressurized fluid source such as a syringe. The fluid inlet port may be configured for receiving liquid to hydrate the vaso-occluding particles and the fluid output port may be configured for dispensing the liquid and the vaso-occluding particles, typically into an implanted catheter having delivery to a target location in a patient's body. [0008]
  • The container will usually include at least one chamber or passageway to hold the particles. The passageway or chamber may have various shapes. For example, the passageway may be straight, curved, conical, narrow, spiral, helical and otherwise shaped. The container and/or chamber(s) and passageway(s) may have multiple sections and the sections may have varying cross sectional areas. The various constructs of the chamber facilitate introduction of the particles into the delivery catheter. [0009]
  • The characteristics of the elements may vary. In one variation, the elements are particles having an outer width or diameter in the range of 40 μm to 2 mm, usually 100 μm to 1400 μm. In another variation, the elements are filaments, typically having a length in the range from 0.5 mm to 1000 mm, usually from 10 mm to 1000 mm, and often from 10 mm to 100 mm, and a width or diameter in the range from 75 μm to 5 mm, usually from 100 μm to 2 mm, and often from 100 μm to 1 mm. The elements will be hydratable, i.e. capable of absorbing saline or other aqueous medium (referred to hereinafter as a hydration or hydrating medium), typically being formed from a polymeric hydrogel material, more typically being formed from a natural or synthetic polymer. A particularly preferred polymer is polyacrylonitrile, but a variety of other suitable polymers are listed hereinbelow. [0010]
  • In another variation, the elements are particles and the container includes a mixing member. The mixing member may be elongate and have a first section outside of the container and a second section with, for example, a stirrer that contacts and moves the particles when the stirrer is rotated. [0011]
  • Another container includes a conical distal end section. The conical distal end section decreases in diameter towards the fluid outlet port. The conical portion may be sized to fit within the proximal end of a delivery catheter. [0012]
  • Another container includes at least one fluid relief port and at least one fluid relief passageway fluidly connected with the fluid relief port. The fluid relief port may have a size smaller than that of the particles such that the particles cannot pass therethrough. The fluid relief passageways may extend to the fluid outlet port such that liquid driven through the container flows through the chamber and the fluid relief passageway while the particles are permitted only to flow through the chamber. [0013]
  • In another variation, the container may include at least one one-way valve. [0014]
  • In another variation, the container includes a membrane or screen. For example, the container may comprise a first chamber in fluid communication with an inlet port and a second chamber in fluid communication with an outlet port. The first chamber and the second chamber may be separated by a support member having at least one opening larger than the vaso-occluding particles or filaments. When the opening is not covered, fluid and the occluding materials may pass through. The container may further comprise a movable screen positioned across the support and the screen may include at least one particle-blocking section and at least one particle-passing section. The particle-blocking section has a plurality of apertures smaller than the particles and the particle-passing section has at least one aperture larger than the particles. The screen is movable such that when the particle-passing section of the movable screen is aligned with the opening of the support the particles may enter the second chamber. Also, when the particle-passing section of the movable screen member is not aligned with the opening of the support the particles may not enter the second chamber. [0015]
  • In another variation, the container may include a fluid outlet and a screen member disposed across the outlet. The screen member may be fixed and the outlet may be coverable. The screen member may have a plurality of apertures and each of the apertures is smaller than the particles or filaments such that the particles may not pass through the outlet. [0016]
  • A kit may also include a cap to cover one or both of the fluid inlet and fluid outlet ports. Additionally, the fluid inlet and fluid outlet ports may have Luer-type or other threaded fitting to fluidly connect the syringe and delivery catheter to the container. [0017]
  • Another kit comprises a hydratable filamentary occluding material and a container holding the material. The material may comprise polyacrylonitrile. The container may have a first opening for fluid flow and a second opening for fluid flow and exit of the filamentary occluding material. At least one of the openings may be adapted for connection to a fluid source such as a syringe. [0018]
  • Also, one of the first and second openings may be adapted for connection with a delivery catheter. The container may further include at least one chamber or passageway to hold the fluid and the filaments. [0019]
  • The passageway or chamber may be variously shaped. For example, the passageway may be straight, curved, conical, narrow, spiral, helical and otherwise shaped. The container may have multiple sections and the sections may have varying cross sectional areas. The various constructs of the chamber facilitate introduction of the particles into a delivery catheter. [0020]
  • In another variation, the passageway of the container is configured to allow only one filament of occluding material pass therethrough at a time. The diameter of the passageway may be in the range of 100 μm to 5 mm. [0021]
  • Also, the shape of the container itself may vary. The container may have, for example, a disk-, card-, cylindrical-, or turnip-shape. The container may also include a screen or membrane. The membrane may have openings sized to prevent the filament material from passing therethrough but allow liquid to pass therethrough. [0022]
  • Another container includes a rotatable barrel. The barrel may have multiple passageways for holding filaments and a body having a single ejection channel. To deliver a selected filament, one of the multiple passageways is aligned with the channel such that a fluid pathway is formed from the fluid source to the outlet port of the container. [0023]
  • A method for holding and introducing vaso-occluding materials into a delivery catheter is also provided herein. The method may include the steps of hydrating the material in a container and pushing at least a portion of the material from the container, to a target site. The pushing step may be performed using fluid pressure or a displacing member. The occluding materials may be a filament. [0024]
  • The method may also include the additional step of severing the filament at a selected location along the length of the filament. The severing may be performed e.g., by pinching, cutting, ablating, twisting, pulling, or similarly detaching the filament. The pinching may be performed using an expandable balloon. Also, the breaking may be performed using a noose or snare. The point of severing may be distal or proximal to the distal end of the catheter and perhaps, within the container. [0025]
  • Yet another method includes an additional step of detecting discrete sections of the filament along its length. The sections may be marked or enlarged to provide information or feedback to a doctor or physician. The filament may then be broken at a selected point upon detecting a certain number of segments. The point of severing may be distal or proximal to the distal end of the catheter and perhaps, within the container. [0026]
  • A preferred container for holding hydratable vaso-occluding elements comprises a delivery tube having an inlet end, a delivery end, and a lumen extending from the inlet end to the delivery end. The delivery tube has a length of at least 5 cm, typically being from 10 cm to 10 m, usually from 20 cm to 1 m, and often from 100 cm to 500 cm, and the lumen has a maximum width along the length in the range from 75 μm to 5 mm, typically from 250 μm to 2 mm. The lumen of the delivery tube provides the passageway or chamber for holding the hydratable elements, and its narrow, elongated configuration is particularly useful since it permits the controlled delivery and dispensing of the elements. In particular, the length and width of the lumen may be selected to receive single filaments in a manner where the filaments do not fold on themselves or otherwise become clogged or restricted within the lumen. Similarly, the luminal dimensions can be selected to permit arrangement and dispensing of particles in a single file, i.e. where the width of the lumen is equal or greater than the particle width but limited to permit passage of only a single element at a time, e.g., being less than twice the particle width, so that particles may not pass each other in the lumen. [0027]
  • The delivery tube will further include an inlet coupling disposed on the inlet end, where the inlet coupling is adapted to be fluidly coupled to a syringe or other fluid source, typically being a Luer fitting. As the delivery tube is typically lengthy, it will usually be configured to reduce its length, typically having at least a portion configured as a helix, spiral, serpentine structure, or other folded or meandering path which will reduce the container length while maintaining the length of the delivery tube lumen. Depending on the pattern in which the delivery tube is configured, the delivery tube may be mounted on various substrates or matrices. For example, helical delivery tubes may be wound over a cylindrical barrel, be wound inside of a cylindrical barrel, or the like. Spiral and serpentine delivery tubes may be mounted on planar cards. The containers and the hydratable elements may be supplied to the user separately, but will more usually be supplied in combination. For example, the hydratable vaso-occluding elements may be stored or maintained within the delivery tube lumen in a hydrated state, a partially hydrated state, or a non-hydrated state. In all cases, both the container and the hydratable elements will be sterile and maintained in a sterile package, such as a pouch, tube, box, blister card, or the like. Alternatively, the container and the vaso-occluding elements may be packaged in separate sterile containers, where the vaso-occluding elements again may be maintained in a hydrated, partially hydrated, or non-hydrated state. In all cases, when the vaso-occluding elements are provided in a non-hydrated or partially-hydrated state, it will be necessary to combine and mix the particles with a suitable hydrating medium, which medium may also be provided as part of the kit or system. [0028]
  • In preferred constructions, the delivery tube of the container will have a generally straight end formed over a length of at least 1 cm, where the straight end is adapted to be received in a hub of a delivery catheter, such as a micro catheter having a hub passage with a diameter in the range from 0.4 mm to 5 mm, typically from 0.5 mm to 1.5 mm. Usually, the hub passage which receives the end of the delivery tube will be tapered. In some instances, the straight delivery end of the delivery tube will also be tapered in order to mate with and form a seal with the tapered passage of the hub. Alternatively, a spherical or other seal may be provided over the straight end of the delivery tube in order to provide a seal with the passage in the hub of the delivery catheter. [0029]
  • In another preferred aspect of the present invention, a method for introducing vaso-occluding elements into an implanted catheter comprises providing said elements in a hydration liquid in a delivery tube having the dimensions set forth above. The delivery end of the delivery tube is mated with the hub of an implanted catheter, and the elements in the hydration liquid are transferred from the lumen and through the delivery end of the delivery tube into a lumen of the implanted catheter. The elements may thus be delivered to any target site in the body to which the implanted catheter is directed. The methods of the present invention may employ delivery tubes configured in any of the geometries described above in connection with the apparatus of the present invention. [0030]
  • In preferred aspects of the method, providing may comprise drawing said elements from a pool of hydrated elements into the lumen of the delivery tube. For example, when the elements comprise filament(s), drawing may comprise applying a vacuum on an inlet end of the delivery tube to capture an end of the filament and draw the length of the filament into the lumen of the delivery tube. Usually, the lumen will have been primed with the hydration liquid using a syringe, where the syringe is the used to apply the vacuum to capture the filament. Alternatively, the delivery tube may be provided as a sterile package with the elements in the lumen, either in a hydrated, partially hydrated, or non-hydrated form. [0031]
  • Mating of the delivery end of the delivery tube with the hub passage usually comprises forming a seal between the delivery end of the delivery tube and the passage of the catheter hub. The seal may be formed by engaging a tapered region of the delivery end in a tapered passage of the catheter hub. Alternatively, sealing may be performed by mating a spherical seal, plug element typically on the delivery end of the delivery tube in a tapered passage of the catheter hub. Still further alternatively, mating may comprise forming a hemostatic seal over an exterior of the distal end of the delivery tube, where the seal extends to the passage of the catheter hub. [0032]
  • After the delivery end of the delivery tube has been mated and sealed with the catheter hub, the vaso-occluding elements are transferred to a catheter lumen, typically by applying pressure at an inlet end of the delivery tube lumen. Pressure causes the fluid and vaso-occluding elements to flow into the lumen of the delivery catheter. Alternatively, transfer may be achieved by passing a pushrod through an inlet end of the delivery tube lumen and pushing the elements with the rod. The latter approach provides for precise transfer of the vaso-occluding elements, particularly for filaments where the length delivered from the delivery end of the catheter may be carefully monitored and controlled. [0033]
  • In yet another aspect of the present invention, a system for delivering vaso-occluding elements comprises at least one hydratable vaso-occluding element having a width when hydrated. A delivery tube having an inlet end, a delivery end, and a lumen extending from the inlet end to the delivery end is adapted to hold the hydratable vaso-occluding element(s). In order to avoid tangling of individual filaments and to assure single-file delivery of multiple particles and filaments, the lumen of the delivery tube has a width along its length which is at least as large as the width of the vaso-occluding element and typically (although not necessarily) less than twice the width of the vaso-occluding element. [0034]
  • In yet another aspect, methods according to the present invention for delivering hydratable vaso-occluding elements to a target body location comprise singly dispensing one or more vaso-occluding elements through a delivery tube to a catheter lumen. The lumen of the delivery tube is adapted to pass only a single vaso-occluding element at a time past any point in the lumen. Thus, the vaso-occluding elements may be dispensed with a hydrating fluid into the catheter lumen one at a time. The method can be employed with both filaments and particles.[0035]
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • FIG. 1 is a perspective view of a container. [0036]
  • FIG. 2 is an illustration of a catheter assembly. [0037]
  • FIG. 3[0038] a is an illustration of an application showing vaso-occluding particles being delivered to a plurality of blood vessels for treatment of a tumor.
  • FIG. 3[0039] b is an illustration of another application showing vaso-occluding particles being delivered to an aneurysm.
  • FIG. 4 is an exploded view of a catheter assembly. [0040]
  • FIGS. 5[0041] a-5 n are partial cross sectional views of various containers for holding vaso-occluding particles.
  • FIGS. 6[0042] a-6 k are partial cross sectional views of various containers for holding vaso-occluding elements.
  • FIG. 7[0043] a is a partial cross sectional view of another catheter assembly having a rotatable multi-passageway container.
  • FIG. 7[0044] b is a cross sectional view of the container shown in FIG. 7a taken along line 7B-7B.
  • FIG. 7[0045] c is a cross sectional view of the container shown in FIG. 7a taken along line 7C-7C.
  • FIG. 7[0046] d is a cross sectional view of yet another catheter assembly having a planar-shaped multi-passageway container.
  • FIGS. 8[0047] a-8 d are illustrations of various techniques for breaking or severing a filament.
  • FIGS. 9 and 10 illustrate a preferred embodiment of a container system constructed in accordance with the principles of the present invention. FIG. 9 shows system components in an exploded view, while FIG. 10 shows the system in an assembled view. [0048]
  • FIGS. 11A and 11B illustrate alternative delivery tube-catheter hub interface configurations taken along line [0049] 11-11 of FIG. 10.
  • FIGS. 12A and 12B illustrate an exemplary method according to the present invention for capturing and loading a filament into the container system of FIGS. 10 and 11. [0050]
  • FIGS. 13 and 14 illustrate alternative delivery tube configurations which could be used with the container system of FIGS. 10 and 11.[0051]
  • DETAILED DESCRIPTION OF THE INVENTION
  • Described below are containers and methods for holding and delivering vaso-occluding materials to a target site. [0052]
  • FIGS. [0053] 1-2 illustrate one variation of a container. In particular, a barrel-shaped container (10) is shown holding vaso-occluding materials (12) described further below. The container (10) includes a fluid inlet port (14), which can be removably connected to a fluid source such as a syringe (18). The container (10) further includes a fluid outlet port (16) which can be removably connected with a vaso-occlusive delivery device such as delivery catheter (20).
  • During operation, fluid pressure from the syringe drives the vaso-occluding materials from the container ([0054] 10) into the delivery catheter (22). Fluid pressure is further supplied to urge the vaso-occluding materials through the delivery catheter and out its distal end (22). In this manner, vaso-occluding materials are delivered to a target site. Target sites include, but are not limited to, the abnormal vasculature of a tumor, aneurysms and other sites of abnormal blood flow as well as vessels, ducts and cavities that are not part of the blood vascular system.
  • Vaso-Occluding Elements and Materials
  • The containers described herein may hold and introduce vaso-occluding elements and materials into a delivery catheter. The vaso-occluding elements include but are not limited to vaso-occluding particles (e.g. biocompatible polymeric microspheres) and vaso-occlusive filaments and filamentary materials (e.g., hydrophilic polyacrylonitrile or HYPAN). The vaso-occluding elements may be made from a variety of substances including hydrogel polymers and other polymers. Examples of hydrogel polymers and polymers include: polyacrylamide (PAAM), poly (N-isopropylacrylamine) (PNIPAM), poly (vinylmethylether), poly (ethylene oxide), poly (vinylalcohol), poly (ethyl (hydroxyethyl) cellulose), poly(2-ethyl oxazoline), Polylactide (PLA), Polyglycolide (PGA), Poly(lactide-co-glycolide) PLGA, Poly(e-caprolactone), Polydiaoxanone, Polyanhydride, Trimethylene carbonate, Poly(β-hydroxybutyrate), Poly(g-ethyl glutamate), Poly(DTH-iminocarbonate), Poly(bisphenol A iminocarbonate), Poly(orthoester) (POE), Polycyanoacrylate (PCA), Polyphosphazene, Polyethylenoxide (PEO), Polyethlglycol (PEG), Polyacrylacid (PAA), Polyacrylonitrile (PAN), Polyvinylacrylate (PVA), Polyvinylpyrrolidone (PVP), a co-polymer of two or more polymers, and a blend of two or more polymers. [0055]
  • The hydrogel polymer or polymers may also comprise a natural polymer. Examples of natural polymer include collagen, silk, fibrin, gelatin, hyaluron, cellulose, chitin, dextran, casein, albumin, ovalbumin, heparin sulfate, starch, agar, heparin, alginate, fibronectin, fibrin, keratin, pectin, elastin, and copolymers and blends of the polymers. [0056]
  • Alternatively, the materials may comprise a bioactive agent and or a radio-pacifier to facilitate visualization of the vaso-occluding materials at a target site. [0057]
  • A particular element which may be used in conjunction with the containers described herein is a hydrogel filament. In one variation, the filament is comprised of an extruded polyacrylonitrile. One way of fabricating such a filament is by the process of dissolving the polyacrylonitrile in DMSO and extruding it into an alcohol bath, whereupon the polyacrylonitrile solution forms a filament. The filament is then removed from the alcohol (e.g. isopropyl or like alcohol) and allowed to dry. Prior to implantation in a patient the filament may be hydrated. Alternatively, the filament may be stored in a hydrated state. The filament can then be injected or delivered in a delivery tool to a chosen site in the patient. The hydrated filament forms a vaso-occlusive filamentous mass and occludes normal flow. [0058]
  • Dimensions for the vaso-occlusive devices may be as desired for a specific purpose, but generally would be in a range from about 0.005 inches (0.125 mm) to about 0.50 inches (12.5 mm). The diameter of the occluding particles will typically be in the range of 40 μm to 2 mm, usually from 100 μm to 1400 μm. The filaments and other occluding filamentary materials may have a diameter in the range of 75 μm to 5 mm, usually 100 μm to 2 mm, more usually from 100 μm to 1 mm. Also, the diameter of the vaso-occlusive materials may be selected such that they may pass through a delivery device such as a delivery catheter. The lengths of the vaso-occlusive filaments as delivered may be generally in the range from about 0.5 mm to about 5 meters, usually being from 0.5 mm to 1 meter, typically being from 10 cm to 100 cm. The width or diameter of the vaso-occlusive element once it is delivered and after it has assumed its vaso-occluding shape (i.e., the deployed filament) may be in a range from about 75 μm to about 5 cm. [0059]
  • A description of particular hydrogel materials may be found in U.S. Patent Application Publication Nos. 2002/0193813A1; 2003/004533A1; 2003/004568A1; and 2002/0193812A1, each of which are assigned to the assignee of the present application and hereby incorporated by reference in their entirety. [0060]
  • Procedural Overview of Vaso-Occluding Treatments
  • FIGS. 3[0061] a-3 b show examples of deploying vaso-occlusive particles. Referring to FIG. 3a, a tumor (50) is shown being treated with vaso-occluding particles (60). In particular, vaso-occluding particles such as the hydrogel particles discussed above are shown being delivered from a delivery catheter (62) to various blood vessels (64) supplying blood to the tumor (50). The vaso-occluding particles form blockages in the vessels (64) leading to the tumor. Accordingly, the blood to the tumor is cut off, inhibiting tumor growth.
  • FIG. 3[0062] b illustrates treatment of an aneurysm (70). In FIG. 3b, vaso-occluding particles (72) are delivered into the aneurysm (70). The vaso-occluding particles form an occlusive mass in the aneurysm, minimizing its undesirable effects on the artery.
  • Also, instead of (or in addition to) vaso-occluding particles, occluding filaments may be supplied to form blockages in the vessels or an occlusive mass in the aneurysm. [0063]
  • It is to be understood, however, that the containers and occluding materials described herein are not limited to occluding blood vessels or aneurysms. Rather, the containers and occluding materials described herein may be used to form occlusions in any of the vessels, ducts, and cavities found in the body including but not limited to vessels found in the blood vasculature. [0064]
  • In both FIGS. 3[0065] a and 3 b, the distal tip of a delivery catheter (62, 74) is positioned near the target site via a catheterization procedure. One catheterization procedure for treatment of various vascular defects includes inserting a sheath into an artery such as the femoral artery. Inserting a guidewire into the sheath and advancing the guidewire to the desired site such as a tumor or aneurysm. Next, a catheter assembly including an elongate introducer catheter is inserted into the sheath and the catheter assembly is advanced over the guidewire to the target site. Once the catheter assembly is properly positioned at the target site, the guidewire is removed from the introducer catheter. A delivery catheter is then inserted within the introducer catheter until the distal end of the delivery catheter is positioned at the site to be embolized. Vaso-occluding materials are fed into the delivery catheter and delivered to the treatment site.
  • Additional examples of catheter assemblies are discussed in, for example, U.S. Pat. Nos. 5,382,260 and 5,476,472. Also, other catheter assemblies known to those of skill in the art may be used in conjunction with the delivery devices and occluding materials described herein. Devices and methods for treating aneurysms and the like are also described in U.S. application Ser. No. 10/106,870 filed Mar. 25, 2002 entitled “Devices And Methods For Treating Vascular Malformations” by Sepetka et al. which is a continuation in part application of U.S. application Ser. No. 09/695,637, filed Oct. 24, 2000, which is a continuation in part of U.S. application Ser. No. 09/324,359 filed Jun. 2, 1999, each of which is incorporated by reference in its entirety. [0066]
  • Vaso-occluding materials may be delivered to a treatment site through a delivery catheter. An example of a particular delivery catheter assembly ([0067] 400) for use with the present invention is shown in FIG. 4 and includes a syringe (410), a cartridge or container (420) and a delivery catheter (430). The delivery catheter assembly shown in FIG. 4 shows the cartridge separated from the syringe. However, the invention is not so limited and the cartridge may be integrally connected with the syringe. In yet another variation, the cartridge is integral with the delivery catheter (430). Kits may also be provided having a cartridge with a plurality of vaso-occluding particles and or a hydrating liquid contained therein.
  • To reiterate, these various containers and cartridges may be connectable with a delivery catheter. As described, vaso-occluding materials held in the containers may be hydrated, washed, or mixed in the container. The vaso-occluding materials may then be injected into the delivery catheter by fluid pressure or some other way such as by use of a displacement wire for implantation in a target treatment site. The containers may have fluid inlet and outlet ports and at least one passageway connecting the fluid inlet port to the fluid outlet port. The shapes, number of passageways, and other features of the containers may take various configurations, discussed below. [0068]
  • Containers for Holding Vaso-Occluding Particles
  • FIG. 5[0069] a illustrates a container (510) having a cylindrical shape for holding vaso-occlusive materials. The container includes a fluid inlet port (512) and fluid outlet port (514). The fluid inlet port and the fluid outlet port are adapted to fluidly connect the container to a syringe and delivery catheter respectively. The ends of the container may have Luer-type fittings for convenient assembly with the syringe and delivery tool.
  • In this variation, the container includes a chamber or passageway ([0070] 516) fluidly connecting the fluid inlet port and the fluid outlet port. A liquid (518) and vaso-occluding particles (520) are held in the chamber (516). The particles are urged towards the fluid outlet port (514) by fluid pressure and flow. The vaso-occluding particles are injected into, for example, a delivery catheter (not shown) through the fluid outlet port.
  • The container may be made of various materials such as but not limited to polymers, copolymers, glass, metals or alloys. For example, the container may be made of a transparent polymer material such as clear polycarbonate. The container may be fabricated in components or sections and bonded together using heat treatment, adhesives and ultrasonic welding, for example. The container and its components may be, for instance, injection molded, machined and micromachined. Other techniques for forming the container and or its components may be used as is known to those of skill in the art. The container may also comprise a variety of coatings or treatments such as a hydrophilic coating. [0071]
  • The dimensions of the container should be sufficient such that the containers can fluidly connect with various conventional syringes and delivery catheters. However, the dimensions may vary such that the container may be adapted to connect with other types of liquid sources (e.g., a gas line) and delivery devices. [0072]
  • FIG. 5[0073] b illustrates another container (530). The container (530) shown in FIG. 5b differs from that shown in FIG. 5a in that the chamber includes a ramped portion 532. Ramp portion (532) focuses the vaso-occluding particles (534) at the outlet port. This generally serves to “meter” the particles as they are ejected from the container, preventing clumping.
  • FIG. 5[0074] c illustrates another container (534) also having a ramped portion (536). However, in this variation, a fluid relief lumen (538) is provided along the ramped portion. A plurality of relief openings (539) fluidly connect the chamber to the fluid relief lumen. The relief openings are sized to permit only liquid (not the vaso-occluding particles) into the fluid relief lumen.
  • Accordingly, liquid may be driven through the container and into the delivery catheter regardless of the degree of particle clogging at the container outlet. In this variation, therefore, vaso-occluding particles in the catheter may be pushed through the catheter by fluid pressure regardless of the degree of particle clogging in the container. [0075]
  • FIG. 5[0076] d illustrates another container (540) having a first chamber (542) for holding a plurality of vaso-occluding materials (544) and a passageway (546). The diameter of the passageway (546) may be adjusted to provide an optimal particle throughput. In this variation the passageway has a diameter equal to that of a particle (548). The narrow passageway (546) is to help organize the particles as they enter a delivery catheter (not shown).
  • FIG. 5[0077] e illustrates yet another container (554). The container shown in FIG. 5e differs from that shown in FIG. 5d in that the container (554) of FIG. 5e includes a spiral passageway (556). Like the container shown in FIG. 5d, the container shown in FIG. 5e provides for organized particle transport and ejection.
  • FIG. 5[0078] f illustrates yet another container. The container shown in FIG. 5f includes a mixing member (560) for displacing the vaso-occluding materials. Mixing the particles prevents the particles from clumping. Mixing member (560) includes a handle portion that is outside the container and a working portion that is inside the chamber. The mixing member may also include fingers (562). The fingers (562) contact and move the vaso-occluding materials when the mixing member is moved (or rotated). The mixing member may be movable linearly and or angularly. Accordingly, the variation shown in FIG. 5f provides a container which actively prevents clumping of vaso-occluding particles near the outlet.
  • FIG. 5[0079] g illustrates a container having a constant diameter passageway (572) and a tapered distal end (570). When the container is connected with a delivery catheter, the tapered distal end (570) extends into the proximal end of the catheter. This extends the constant diameter passageway into the delivery catheter and alleviates problematic flow effects arising from the entrance of the delivery catheter.
  • FIG. 5[0080] h illustrates another container having a one-way valve (578). The valve (578) may be a duckbill valve made of an elastomeric material which remains closed in its relaxed state. Upon applying fluid pressure from the fluid inlet port (580), the valve opens allowing fluid to pass. However, fluid and particles cannot pass the other direction. The valve may be positioned at the outlet end or at another location of the container. Also, multiple valves may be used to provide particular flow control schemes.
  • The vaso-occluding particles may be hydrated with a hydration liquid and the hydration liquid may be pushed through, for example, a screen or membrane or the like. A second liquid may be supplied to the container to purge the first liquid and to drive the vaso-occluding particles to a desired site. The second liquid may be a therapeutic liquid. Examples of therapeutic liquids include but are not limited to analgesics, anesthetics, antibiotics, thrombotic agents, chemotherapeutic drugs, and thrombolytic agents. A particular example is doxorubicin, which is used to treat tumors. Also, a contrast agent for visualization can be used. Accordingly, the target site can be simultaneously treated with embolizing particles and a therapeutic liquid. [0081]
  • FIG. 5[0082] i illustrates a variation using a movable screen (582). The screen has openings, which allow liquid, but not particles, to pass. The screen (582) may be pie shaped as shown in FIG. 5l and it may have at least one open region (583) (or open “slice”). Also, the open region may include apertures so long as at least one of the apertures is larger than the vaso-occluding particles. When this particle-passing region (583) is aligned with an opening on a screen support such as support (585), vaso-occluding particles may pass therethrough. When the regions are not aligned, only fluid (and not the particles) may pass.
  • FIG. 5[0083] j illustrates a container having a fixed screen (584) and a cap (588) covering the outlet (586). The screen has openings that permit fluid, but not particles, to pass. The container shown in FIGS. 5i-5 j may be used to hydrate vaso-occluding particles and provide a way to replace the hydrating fluid with a second, perhaps therapeutic fluid.
  • FIG. 5[0084] k illustrates another container (590). In this example, the container (590) includes a spiral passageway (592) leading to a ramped chamber (594). The ramped chamber further leads to a straight passageway (596).
  • The spiral passageway ([0085] 592) includes at least one particle aperture (598) through which vaso-occluding particles moving along the passageway may pass. Thus, some particles fall through the apertures (598) and other particles continue down the spiral passageway (592). The particles that fall through the apertures bypass one or more turns in the spiral passageway and directly enter the ramped section (594). The ramped chamber shown in this variation is tapered and focuses the particles into a straight passageway (596) which accepts only one particle at a time. Accordingly, the container (590) focuses vaso-occluding particles into an attached delivery catheter (not shown).
  • FIG. 5[0086] m shows a container (1500) having a helical passageway (1502) extending from a fluid inlet (1504) to a fluid outlet (1506). The helical passageway of FIG. 5m, however, does not include apertures along its path so that particles (and/or filaments) stay in line along the helical path before reaching the fluid outlet. In still another variation, as shown in FIG. 5n, a container (1510) has a helical path (1512) extending from an inlet (1514) to a ramped section (1516) which focuses or funnels the occluding materials to a fluid outlet (1518). Accordingly, containers described herein may have helical passageways which do include apertures along their paths and helical passageways which do not include apertures along their paths. The helical passageways may extend to fluid outlets or the passageways may lead to another focusing chamber such as a ramped section, which focuses the occluding materials to a fluid outlet.
  • Containers for Holding Vaso-Occluding Filaments
  • The containers described herein may also hold and deliver vaso-occluding filaments, such as those described in the co-pending applications incorporated herein by reference above, the full disclosures of which are incorporated herein by reference. [0087]
  • FIG. 6[0088] a illustrates a particular container (600) suitable for delivering a filament (602). Similar to the above described containers, the container (600) shown in FIG. 6a includes an inlet (604) for receiving liquids, a passageway or chamber (606) for holding the filament and liquids (607), and an outlet (608) for ejecting the filament and or liquid. The inlet end and outlet end can be designed to fluidly connect with a fluid source (e.g., a syringe) and a delivery catheter respectively. In operation, the filament is hydrated and ejected from the outlet (608) into, for example, a delivery catheter. The chamber shown in FIG. 6a may be cylindrical and substantially larger in diameter than the filament (602). However, the invention is not so limited and other shapes of chambers are contemplated.
  • FIG. 6[0089] b illustrates another container (610) having a spiral passageway (612). The spiral passageway (612) is very space efficient and holds very long filaments in short containers. A displacement member or wire may be provided to push the filament through the passageway. The displacement wire may be a flexible metal or alloy. The displacement wire may be made of, for example, NITINOL. Such a displacement member may include markings along its length. The marks may be equally spaced to provide an idea or measure of the length of filament ejected from the distal end of the catheter. Alternatively, syringes connected at distal end (611) of the container (610) may be used to draw in and eject individual or multiple filaments.
  • FIG. 6[0090] c shows yet another container (620) having a set of ganged passageways (622) for holding and delivering multiple filaments (624) in parallel. The container (620) shown in FIG. 6c also includes a ramped portion (626) to focus the filaments towards the delivery end. FIG. 6d shows a cross sectional view of the container along 6 d-6 d. This container provides for multiplexed filament delivery.
  • FIGS. 6[0091] e-6 f illustrate another container (630) for holding filaments (632). The container (630) shown in FIGS. 6e and 6 f is shaped like a disk. The container (630) includes a passageway (634) for holding and delivering a filament (632) from an inlet (636) to an outlet port (638). The passageway may be a spiral, serpentine, or other curved shape to connect the inlet (636) to the outlet (638). Also, it is to be understood that the shape of the container may vary greatly and include, for example, cylindrical, disk, rectangular, oval, turnip, and other shapes.
  • FIGS. 6[0092] g and 6 h illustrate another container (640) similar in function to those shown in FIGS. 6e-6 f. These figures depict a centerline of inlet (642) and the centerline of outlet (644) separated by a distance (D).
  • FIG. 6[0093] i illustrates yet another container (650) including a membrane (652) between a base (654) and a cover (656). The base, membrane and cover are detachably connected such that pre-selected membranes may be added or removed for various applications. Also, the components should be fluidly sealed to prevent leaks.
  • One application for container ([0094] 650) is filament hydration. A hydrating liquid is supplied to the passageway (662) via inlet (658), hydrating the contents therein. The liquid may then be driven through membrane (652) and ejected from outlet (660). The membrane includes openings that prevent the filament from passing therethrough yet allow the hydrating liquid to pass therethrough. A variety of membranes and filters may be used to selectively allow certain substances to pass. Once the filament is hydrated, the membrane is removed and the container is connected with a delivery tool to deliver the filament to a target site.
  • FIGS. 6[0095] j-6 k illustrate yet another container (670) having a conical end section (674). The conical end section (674) has a fluid outlet port allowing liquids and vaso-occluding materials to flow therethrough. The conical end section (674) is adapted to extend into (and mate) with the proximal end of a delivery catheter.
  • The conical distal end section ([0096] 674) also includes rinse ports (676) as shown of FIG. 6k. The rinse ports (676) are sized to prevent vaso-occluding materials such as filaments and particles from flowing therethrough but allow liquid to pass therethrough.
  • An application for container ([0097] 670) is filament hydration and delivery. A hydrating liquid is injected into the container. The hydrating liquid hydrates the filament, and exits through the rinse ports (676). The vaso-occluding materials, however, are prevented from passing through the rinse ports due to their size and are prevented from passing through the outlet port (680) due to the cap (678). Once the filaments are hydrated, a second liquid can be supplied to the container purging the hydrating liquid from the system. The cap may then be removed and the container may be connected with a catheter assembly.
  • The distal end section ([0098] 674) may be designed such that the rinse ports (676) are covered by the delivery catheter entrance (not shown) when the catheter is connected with the container. In particular, the conical section (674) extends into the catheter hub such that the rinse ports (676) are covered. Accordingly, vaso-occluding materials and or liquids are forced to pass through the fluid outlet port (680) and into the delivery catheter.
  • Rotatable Multi-Passageway Container
  • FIGS. 7[0099] a-7 c show several views of a delivery catheter assembly having a rotatable multi-passageway container (710). In this variation, a catheter assembly (700) includes a container (710) having a plurality of passageways (712) for holding filaments (714), a syringe (720) for supplying fluid to the container to hydrate and drive the filaments, and a delivery catheter (730) for delivering the filaments to a target site.
  • The container shown in FIG. 7[0100] a includes a revolving barrel (740). The barrel revolves about a central axis. The revolving barrel includes a plurality of passageways (714). The passageways are circumferentially positioned along a circle. See, for example, FIG. 7b. Each passageway (714) is configured to hold vaso-occluding filament. The passageways may take various shapes and be, for example, straight or curved.
  • The revolving barrel also has a fluid inlet port that is fluidly connected with a syringe. The barrel further has a distal end and the passageways extend to the distal end, defining an equal number of filament exit ports. There are four passageways shown in this figure but the invention is not so limited and the barrel may have more or less passageways. [0101]
  • The container also includes a body ([0102] 750), which fluidly connects one of the passageways (714) with the proximal end of the delivery catheter (730). The body includes one channel (752) which can align (or register) with a selected passageway of the plurality of passageways (714). See also FIG. 7c. Once a passageway is aligned with the channel a complete fluid pathway is formed from the syringe to the delivery catheter. Accordingly, a selected filament may be ejected from the container into the delivery catheter.
  • It is to be understood that while the above described variation shows the barrel and syringe being rotatable, the invention is not so limited. Other members may be rotated to achieve a complete fluid pathway for filament delivery. Also, the container may be “closed” by adjusting the barrel such that no passageways are aligned with the channel, fluidly sealing each passageway. [0103]
  • FIG. 7[0104] d shows another catheter assembly (760) having a movable multi-chamber container (770). This variation is different than the above barrel shaped variation in that it is card-shaped. Also, the container moves in a plane such as the XY plane. The passageways from the movable device are aligned with a channel of the body component (780) to create a fluid path connecting the syringe to the delivery catheter. Accordingly, filaments may be pushed through the container and to the target site.
  • Filament Length Control
  • When delivering vaso-occluding filaments to a target site, it is sometimes desirable to break or sever the filament. For example, in selecting a specific size filament for filling an aneurysm it is desirable to break the filament at a certain location along the length of the filament. Various techniques for breaking the filaments are described herein. [0105]
  • One technique for severing a filament is shown in FIGS. 8[0106] a and 8 b. These figures depict inflating a balloon member (810) to pinch a filament (812) between the balloon and the inner wall (816) of a delivery catheter. As the balloon member expands it continues to pinch the filament until the filament severs.
  • Another “pinching” technique is shown in FIG. 8[0107] c. In FIG. 8c, an enlarged member (820) is provided. When the enlarged member (820) is moved proximally, it pinches the filament (822) against the delivery catheter wall, breaking the filament. The enlarged member may have a ball shape. The enlarged member may also be, for example, a knot.
  • Another technique for breaking a length of filament is shown in FIG. 8[0108] d. In particular, a noose (832) surrounds the filament (834) at a selected location. The noose (832) is tightened by pulling the member (830) thereby breaking the filament. An exemplary snare device is shown in U.S. Pat. No. 6,312,421 to Boock.
  • Still other techniques for breaking the filament include providing the filament with a detachable joint. The detachable joint may be activatable or dissolvable upon receiving various stimuli such as, for example, blood, pH, electricity, heat, and other stimuli. The detachable region may be scored or otherwise designed to incorporate a localized weak region in the filament. The filament may be stretched across a localized region and the filament will break at the weakened point. [0109]
  • It is to be understood that the filament may be broken or severed at a point distal to the catheter end, within the catheter, and perhaps within the container. [0110]
  • The filament may also contain discrete sections along its length to provide information to the doctor or physician. This information or feedback may be provided by incorporating bulges, knots, radio-opaque markers, or other types of discrete sections (or features) along the length of the filament. The discrete sections may be separated by segments of known length. A sensor may be positioned on the distal end of the delivery catheter to monitor the number of segments exiting the delivery catheter. Given the length of each segment, and the number of segments ejected, the total length of filament dispensed from the catheter may be determined. Once a desirable length of filament has been ejected, the filament is cut. The bulges, knots, etc. may also be used to trigger a mechanism that severs the filament. [0111]
  • Applications
  • As indicated above, containers may hold and introduce vaso-occluding materials to a delivery catheter. The containers may be shipped or delivered to a doctor in a kit form that is ready to be used. Such kits may be designed to include both or either hydrated or unhydrated particles and filaments. Shipping the filaments in a ready-to-use kit minimizes compression of filaments. For example, shipping the filament in a ready-to-use hydrated state minimizes the chance that a filament will break during shipping. Some types of filaments are brittle in their unhydrated state. [0112]
  • Also, the vaso-occluding materials may be packed in particular configurations to optimize packing (e.g., increase packing density). Particles and filaments may be formed in certain shapes (having certain cross sections) such as cubic, hexagonal and triangular so that the particles or filaments interlock and minimize dead space. Spherical and cylindrical shapes may have more dead space when the particles are packed together. [0113]
  • These devices may be used in a wide variety of ways. For example, the vaso-occluding materials may be designed for implantation into the vasculature of a patient. The implantation site may be any site of abnormal blood flow in the patient such as the brain. The abnormal blood flow may be caused by an aneurysm, a ruptured blood vessel, an AVM, a fistula, or a benign or malignant tumor (e.g., cancer or fibroid or the like). Otherwise untreatable tumors are particularly contemplated for treatment by implantation of the vaso-occlusive devices of the invention, as are uterine fibroids and the like. Additionally, the vaso-occlusive devices may be designed for implantation into vessels, ducts and cavities found in the body which are not part of the blood vascular system. [0114]
  • The containers and kits also provide for conveniently hydrating and dispensing particles in a single step. That is, in a single step liquids can be supplied to the container to hydrate the vaso-occluding materials and push them into the delivery catheter. Consequently, there is less likelihood of contamination. [0115]
  • Additionally, various therapeutic liquids may be used with the present invention. The therapeutic liquids are added to the container, purging the first liquid if necessary. Also, the present invention provides for breaking the filaments at certain locations along their lengths. The length of filament ejected may thusly be controlled. Also, graduated lengths of containers may be provided. Each container can include a length of filament corresponding to the size of container. [0116]
  • Referring to FIGS. 9 and 10, an exemplary system ([0117] 900) for holding and delivering vaso-occluding elements to target body locations, typically in the vasculature, will be described. While the system comprises up to four components, a container (902) comprising a delivery tube (904) is the principal novel component of the system. The system (900) may also include a syringe (906) or other conventional device for delivering a hydrating liquid or other fluid under pressure, and implanted catheter (908) comprising a catheter body (910) and a proximal catheter hub (912) (shown in section), and a hemostasis valve (914). The delivery tube (904) has the dimensions generally set forth above, and is typically composed of a polymer, such as polyethylene, although in certain circumstances it could be formed from a metal, glass, or other material. Delivery tube (904) has an inlet end (920) and an outlet end (922), with a Luer or other inlet coupling (924) attached to the inlet end. The outlet end (922) is typically configured as a straight section of the tube (904), although it would be possible to provide connection interfaces or otherwise configure the straight end, as described below in connection with FIGS. 11A and 11B.
  • Because of its length, it is usually desirable to configure or structure the delivery tube ([0118] 904) so that it occupies a considerably lesser length in the container (902). As illustrated in FIG. 9, the delivery tube (904) may be helically coiled over a portion of its length, thus shortening the overall effective length of the container. For example, delivery tubes having lengths in the range from 5 cm to 10 meters, usually from 5 cm to 5 meters, may have coils with a diameter in the range from 5 mm to 20 mm, with from 2 turns to 1000 turns, usually from 5 to 100 turns. Other configurations for shortening the effective length of the delivery tube (904) include planar coils (FIG. 13), planar serpentine configurations (FIG. 14), and the like. As shown in FIG. 9, the coiled section (930) of the delivery tube (904) is mounted over a barrel (932) and/or within an outer tube (934).
  • The hydratable elements to be delivered by system ([0119] 900) will be contained in a lumen of delivery tube (904). The hydratable elements may be stored in a hydrated, partially hydrated, or non-hydrated form, but will in at least most cases be fully hydrated before delivery. The syringe (906) may be utilized for delivering the hydrated vaso-occluding particles from the delivery tube (904) of container (902). In particular, the syringe may be attached to the Luer fitting (924), as illustrated in FIG. 10. The syringe will be filled with a hydrating medium or other suitable liquid for delivery through the delivery tube (904), thus permitting delivery of the hydrated elements by pressurized introduction of the hydrating medium or other liquid.
  • Referring now to FIGS. 11A and 11B, the outlet end ([0120] 922) of delivery tube (904) is received in a passageway (940) of the catheter hub (912). Preferably, a pressure-type seal (i.e., a seal which prevents leakage under the expected infusion pressures) will be formed between the outlet end (922) and the interior wall of the hub passage (940). For example, a spherical seal (942) may be formed at the distal tip of the delivery tube (904), where the spherical seal engages and seals against a tapered region of the passageway in the catheter hub. Alternatively, the distal end of the delivery tube (904) may itself be tapered so that it seats in and seals against the passageway (940), as shown in FIG. 11B. Optionally, as shown in FIG. 11C, the outlet end (922) may be held in a spring (923) which allows the spherical seal (942) to compressibly engage the interior (940) of the hub (912). The hub (912) will be directly connected to a Luer or other fitting (925) in the container (902). It would also be possible to substitute a screw mechanism for the spring, although that option is not illustrated. In either case, any extension or compression of the tube (904) can be accommodated by compression or extension of the helical portion of the tube, i.e., the helix will simply act like a spring. In some cases, by properly controlling the elasticity of the tube material, the helical section of the delivery tube (904) could provide the necessary spring force and no separate spring (923) would be necessary.
  • While it is generally preferred to form a seal within the catheter hub, a separate hemostatic valve ([0121] 914) may be provided for sealing against the exterior of the delivery tube (904) at a location immediately proximal to the hub (940), as illustrated in FIG. 10. A hemostatic seal (914) includes Luer fittings at each end so that it may be positioned between the proximal end of hub (912) and distal end of container (902), as illustrated in FIG. 10. By sealing over the exterior of the straight portion of delivery tube (904), a relatively small, enclosed volume is created between the hemostasis valve and the proximal end of catheter body (910). While this volume will receive some flow and pressure from the hydrating medium being introduced through the lumen of the delivery tube (904), the pressure will quickly equalize and the passage of vaso-occluding element(s) and hydrating medium into the lumen of the catheter body (910) will quickly be accomplished.
  • The container system ([0122] 900) may be sterilely packaged and distributed either with or without pre-loaded vaso-occluding element(s). When pre-loaded, the vaso-occluding elements may be hydrated, partially hydrated, or non-hydrated, and at least the container (902) holding the vaso-occluding element(s) will be sterilely packaged. Optionally, other system components may be combined in the same or a separate sterile package.
  • Alternatively, the container ([0123] 902) and/or other system components may be sterilely packaged and distributed separately from the vaso-occluding element(s). In that case, it will be necessary to load the vaso-occluding element(s) into the delivery tube (904) prior to use. As illustrated in FIGS. 12A and 12B, a filament F may be loaded into the delivery tube by first hydrating the filament in a suitable hydrating medium H in a bowl, dish, or the like. After the filament has been hydrated, the outlet end (922) of the delivery tube (904) may be immersed in the hydrating medium H and located next to one end of a filament F. By then pulling on the plunger in syringe (906), hydrating medium and the filament is drawn into the delivery tube, as shown in FIG. 12B. Usually, the delivery tube (904) will be primed with hydrating medium H prior to drawing in the filament F.
  • While the container ([0124] 902) having a helical delivery tube (904) is illustrated in FIGS. 9 and 10, other delivery tube configurations are also possible. As shown in FIG. 13, a delivery tube (980) may be configured as a spiral on one side of a card (982). On the center of the card, the tube may be drawn through to the other side and brought out so that an inlet (984) is available for connection to a syringe, typically with a Luer (986). The delivery or outlet end (988) of tube (980) may be provided with any of the configurations discussed with prior embodiments.
  • As a further alternative, a delivery tube ([0125] 990) may be formed in a serpentine pattern on a support card (992). An outlet or delivery end (994) can extend from one side of the card, while an inlet end (996) having a Luer fitting (998) extends from the other side of the card. In general, both delivery tubes (990) and (980) can be used in place of container (902) and delivery tube (904) in the container system of FIGS. 10 and 11.
  • Other features that may be incorporated into the apparatus of the present invention include mixing mechanisms in the delivery chamber or delivery tube, e.g., fluid flow or a mixing member coupled to the syringe plunger which is advanced with depression of the plunger to mix the elements, particularly particles, to assist in advancement from the delivery chamber to the catheter. It may also be useful to graduate or otherwise mark the delivery tube to indicate filament length, particularly where the marking instructs the user where to cut the tube to ensure compatibility with the catheter hub. [0126]
  • All publications, patent applications, patents, and other references mentioned herein are incorporated by reference in their entirety. To the extent there is a conflict in a meaning of a term, or otherwise, the present application will control. [0127]
  • Although the foregoing invention has been described in some detail by way of illustration and example for purposes of clarity of understanding, it will be readily apparent to those of ordinary skill in the art in light of the teachings of this invention that certain changes and modifications may be made thereto without departing from the spirit or scope of the appended claims. [0128]

Claims (97)

What is claimed is:
1. A kit for holding vaso-occluding elements comprising:
a plurality of hydratable vaso-occluding elements; and
a container adapted to hold the hydratable vaso-occluding elements, said container having an inlet port and an outlet port, wherein at least one of the fluid inlet and outlet ports is adapted for fluid connection with a fluid source.
2. The kit of claim 1 wherein the container comprises a chamber to hold said elements, said chamber having a varying cross sectional area.
3. The kit of claim 2 wherein said varying cross sectional area decreases in a direction from the inlet port to the outlet port.
4. The kit of claim 2 wherein said chamber has a first section and a second section and wherein said first section has a first cross sectional area and said second section has a second cross sectional area different than said first cross sectional area.
5. The kit of claim 4 wherein said second cross sectional area decreases in a direction towards the fluid output port.
6. The kit of claim 5 wherein said first cross sectional area is constant.
7. The kit of claim 1 comprising at least one passageway, said passageway being adapted to allow a controlled number of elements to pass therethrough at a time.
8. The kit of claim 7 wherein said passageway is straight.
9. The kit of claim 7 wherein said passageway is curved.
10. The kit of claim 9 wherein said passageway has one of a spiral or helical shape.
11. The kit of claim 1 wherein said elements are particles and the container further comprises a mixing member, said mixing member being elongate and having a first section outside of said container and a second section within said container for stirring said particles.
12. The kit of claim 11 wherein said second section of said mixing member includes fingers and wherein said mixing member is rotatable.
13. The kit of claim 1 wherein said container comprises a conical distal section, said conical distal section decreasing in diameter and terminating at said fluid output port.
14. The kit of claim 13 wherein said conical distal section is adapted to fit within a proximal end of a delivery catheter.
15. The kit of claim 1 further comprising a one-way valve positioned at at least one of said fluid inlet port and fluid output port wherein when said one-way valve is disposed at said fluid inlet port the valve permits flow only into said container and when said valve is positioned at said fluid output port said valve permits flow only out of said container.
16. The kit of claim 1 wherein said elements are particles and said container further comprises first chamber in fluid communication with said inlet port and a second chamber in fluid communication with said outlet port, said first chamber and said second chamber separated by a support member having at least one opening and said at least one opening being larger than said particles such that when said at least one opening is not covered, fluid and said particles may pass through, said container further comprising a movable screen positioned across said support, said screen having at least one particle-blocking section and at least one particle-passing section, said particle-blocking section having a plurality of apertures smaller than said particles and said particle-passing section having at least one aperture larger than said particles, said screen being movable such that when said particle-passing section of said movable screen is aligned with said opening of said support said particles may enter said second chamber and when said particle-passing section of said movable screen member is not aligned with said at least one opening of said support said particles may not enter said second chamber.
17. The kit of claim 1 wherein said container further comprises a screen member disposed across said outlet, said screen member having a plurality of apertures and each of said apertures being smaller than said elements such that said elements may not pass through said outlet.
18. The kit of claim 1 wherein said elements comprise polyacrylonitrile.
19. The kit of claim 18 wherein said elements comprise spherical particles.
20. The kit of claim 19 wherein said particles have an outer diameter in the range of 40 μm to 2 mm.
21. The kit of claim 1 further comprising a liquid in said container and wherein said elements are hydrated.
22. The kit of claim 1 further comprising at least one cap covering one of said fluid inlet port and fluid outlet port.
23. The kit of claim 1 further comprising a Luer fitting for connecting said fluid source to said fluid inlet port.
24. The kit of claim 1 further comprising a Luer fitting for connecting said outlet port with a delivery catheter.
25. The kit of claim 1 wherein said container further comprises at least one fluid relief port and at least one fluid relief passageway connected to said fluid relief port wherein said at least one fluid relief port has a diameter less than the diameter of said elements and wherein liquid driven through said container flows through said chamber and said fluid relief passageway while said elements flow only through said chamber to said fluid outlet port.
26. A kit comprising:
at least one hydratable vaso-occluding filament; and
a container hold adapted to hold the filament and having an inlet and an outlet wherein at least one of the inlet and outlet is adapted for connection to a fluid source.
27. The kit of claim 26 wherein the inlet is adapted to receive a fluid source and the outlet is adapted for connection to a delivery catheter.
28. The kit of claim 27 wherein said fluid source is a syringe.
29. The kit of claim 26 wherein said filament comprises polyacrylonitrile.
30. The kit of claim 26 wherein said container comprises a passageway having a cross-sectional geometry which allows only one filament of occluding material to pass through at a time.
31. The kit of claim 30 wherein said filament has a diameter in the range of 100 μm to 5 mm.
32. The kit of claim 30 wherein said passageway is at least partly straight.
33. The kit of claim 30 wherein said passageway is at least partly curved.
34. The kit of claim 33 wherein said passageway is spiral or helical over at least a portion of its length.
35. The kit of claim 26 wherein said container has a shape selected from the group consisting of disk-, card-, cylindrical-, and turnip-shape.
36. The kit of claim 26 wherein said container further comprises a membrane, said membrane having openings sized to prevent said filament material from passing therethrough but allowing liquid to pass therethrough.
37. The kit of claim 26 wherein the container comprises a rotatable barrel having multiple passageways for holding filaments, and a body having a single ejection channel wherein when one of the multiple passageways is aligned with said single channel a fluid pathway is formed connecting the fluid source to the outlet port of the container.
38. The kit of claim 26 further comprising a displacement member for pushing the filament material out the container.
39. A method for introducing vaso-occluding elements into a delivery catheter comprising:
hydrating the elements in a container, said container having another end adapted for fluid connection with a delivery catheter; and
pushing at least a portion of the material from the container through the catheter and to a target site.
40. The method of claim 39 wherein said pushing comprises attaching a fluid source to an inlet end of the container and applying fluid pressure from the fluid source.
41. The method of claim 39 wherein said elements comprise at least one filament.
42. The method of claim 41 wherein said pushing is performed with an elongated displacement member.
43. The method of claim 41 further comprising the step of severing the filament at a selected location along the length of the filament.
44. The method of claim 43 wherein said severing is performed by pinching the filament at said location between two surfaces.
45. The method of claim 44 wherein said pinching is performed using an expandable balloon.
46. The method of claim 43 wherein said breaking is performed using a noose.
47. The method of claim 41 wherein said filament includes discrete sections having an enlarged diameter.
48. The method of claim 47 further comprising detecting the sections of enlarged diameter and breaking the filament in response to the detecting.
49. The method of claim 43 wherein the breaking is distal to the distal end of the delivery catheter.
50. The method of claim 43 wherein the breaking is performed in the container.
51. The method of claim 39 further comprising purging the container with a therapeutic liquid and using said therapeutic liquid for pushing.
52. A container for holding hydratable vaso-occluding elements, said container comprising:
a delivery tube having an inlet end, a delivery end, a lumen extending from the inlet end to the delivery end, a length from inlet end to delivery end of at least 5 cm and a maximum lumen width along its length in the range from 0.4 mm to 5 mm; and
an inlet coupling disposed on the inlet end of the delivery tube, said inlet coupling being adapted to fluidly couple to a fluid source;
wherein the delivery tube is configured to reduce the length of the container.
53. A container as in claim 52, wherein the inlet coupling is a Luer connector adapted to connect to a syringe.
54. A container as in claim 52, wherein the delivery tube is configured as a helix over at least a portion of its length.
55. A container as in claim 54, wherein the helix is wound over a cylindrical barrel.
56. A container as in claim 54, wherein the helix is wound inside of a cylindrical barrel.
57. A container as in claim 52, wherein the delivery tube is configured as a planar spiral over at least a portion of its length.
58. A container as in claim 57, wherein the planar spiral is formed over a planar card.
59. A container as in claim 52, wherein the delivery tube is configured in a serpentine pattern over at least a portion of its length.
60. A container as in claim 52, further comprising a plurality of hydratable vaso-occluding particles contained in the lumen of the delivery tube.
61. A container as in claim 60, wherein the particles have an average diameter of 75 μm to 1.5 mm.
62. A container as in claim 60, wherein the particles are not hydrated.
63. A container as in claim 60, wherein the particles are hydrated in a hydrating medium in the lumen.
64. A container as in claim 52, further comprising at least one hydratable vaso-occluding filament contained in the lumen of the delivery tube.
65. A container as in claim 64, wherein the filament has a length in the range from 1 cm to 2000 cm and a width in the range from 75 μm to 5 mm.
66. A container as in claim 65, wherein the filament is not hydrated.
67. A container as in claim 65, wherein the filament is hydrated in a hydrating fluid in the lumen.
68. A container as in claim 52, wherein the delivery end of the delivery tube is straight over a length of at least 1 cm and adapted to be received in a hub of a delivery catheter.
69. A container as in claim 68, wherein the straight delivery end of the delivery tube is tapered to form a seal with a tapered passage in the hub of the delivery catheter.
70. A container as in claim 68, wherein a spherical seal is formed over the straight delivery end of the delivery tube to form a seal with a tapered passage in the hub of the delivery catheter.
71. A method for introducing vaso-occluding elements into an implanted catheter, said method comprising:
providing said elements in a hydration liquid in a delivery tube having a lumen with a length of at least 2 cm and a maximum width along its length in the range from 0.4 mm to 5 mm;
mating a delivery end of the tube with a hub of the implanted catheter; and
transferring said element(s) in the hydration liquid from the lumen and through the delivery end of the delivery tube into a lumen of the implanted catheter.
72. A method as in claim 71, wherein the delivery tube is configured as a helix over at least a portion of its length.
73. A method as in claim 72, wherein the helix is wound over a cylindrical barrel.
74. A method as in claim 72, wherein the helix is wound inside of a cylindrical barrel.
75. A method as in claim 71, wherein the delivery tube is configured as a planar spiral over at least a portion of its length.
76. A method as in claim 75, wherein the planar spiral is formed over a planar card.
77. A method as in claim 72, wherein the delivery tube is configured in a serpentine pattern over at least a portion of its length.
78. A method as in claim 71, wherein providing comprises drawing said elements from a pool of hydrated elements into the lumen of the delivery tube.
79. A method as in claim 78, wherein the elements comprise a filament and drawing comprises applying a vacuum on an inlet end of the delivery tube to capture an end of the filament and draw the length of the filament into the lumen.
80. A method as in claim 79, further comprising priming the delivery tube lumen with the hydration liquid from a syringe and then using the syringe to apply the vacuum.
81. A method as in claim 79, wherein the filament has a length in the range from 1 cm to 2000 cm and a width along their length in the range from 75 μm to 5 mm.
82. A method as in claim 71, wherein the delivery tube is provided as a sterile package with the elements in the lumen.
83. A method as in claim 82, wherein the elements are not hydrated in the sterile package, and providing comprises drawing the hydration liquid into the delivery tube.
84. A method as in claim 83, wherein the elements are present in the hydration liquid in the sterile package.
85. A method as in claim 71, wherein mating comprises forming a seal between the delivery end of the delivery tube and a passage of the catheter hub.
86. A method as in claim 85, wherein mating comprises engaging a tapered region of the delivery end in a tapered passage of the catheter hub to form a seal between the delivery tube lumen and the catheter lumen.
87. A method as in claim 85, wherein mating comprises engaging a plug element on the delivery end in a tapered passage of the catheter hub.
88. A method as in claim 85, wherein mating comprises forming a hemostatic seal over the exterior of the delivery end of the delivery tube and extending to the catheter hub.
89. A method as in claim 71, wherein transferring comprises applying pressure at an inlet end of the delivery tube lumen.
90. A method as in claim 71, wherein transferring comprises passing a push rod through an inlet end of the delivery tube lumen and pushing the elements with the rod.
91. A system for delivering vaso-occluding elements, said system comprising:
at least one hydratable vaso-occluding element having a width when hydrated; and
a delivery tube having an inlet end, a delivery end, and a lumen extending from the inlet end to the delivery end;
wherein the lumen of the delivery tube is adapted to hold said hydratable vaso-occluding element and has a width along its length which is at least as large as the width of the vaso-occluding element and less than twice the width of the vaso-occluding element.
92. A system as in claim 91, wherein the hydratable vaso-occluding element comprises at least one filament.
93. A system as in claim 91, wherein the hydratable vaso-occluding element comprises a plurality of particles.
94. A method for delivering hydratable vaso-occluding elements to a target body location, said method comprising singly dispensing one or more vaso-occluding elements through a delivery tube to a catheter lumen, wherein the lumen of the delivery tube is adapted to pass only a single vaso-occluding element at a time.
95. A method as in claim 94, wherein the vaso-occluding elements are dispensed with a hydrating fluid into the catheter lumen.
96. A method as in claim 95, wherein the hydratable vaso-occluding elements are filaments.
97. A method as in claim 95, wherein the hydratable vaso-occluding elements are particles.
US10/400,185 2002-03-25 2003-03-25 Containers and methods for delivering vaso-occluding filaments and particles Abandoned US20040098024A1 (en)

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US6953465B2 (en) 2005-10-11
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AU2003226024A8 (en) 2003-10-13
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AU2003226024A1 (en) 2003-10-13
WO2003082374A3 (en) 2004-03-25

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