Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
  • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or 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
  • A61B17/12113—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or 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
  • A61B17/12181—Occluding 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
  • A61B17/1219—Occluding 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
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
  • A61L24/001—Use of materials characterised by their function or physical properties
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
  • A61L24/001—Use of materials characterised by their function or physical properties
  • A61L24/0036—Porous materials, e.g. foams or sponges
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
  • A61L24/04—Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials
  • A61L24/046—Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
  • A61L24/04—Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials
  • A61L24/10—Polypeptides; Proteins
  • A61L24/102—Collagen
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
  • A61L31/04—Macromolecular materials
  • A61L31/043—Proteins; Polypeptides; Degradation products thereof
  • A61L31/044—Collagen
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
  • A61L31/04—Macromolecular materials
  • A61L31/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
  • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
  • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
  • A61L31/146—Porous materials, e.g. foams or sponges
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P9/00—Drugs for disorders of the cardiovascular system
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B2017/00831—Material properties
  • A61B2017/00889—Material properties antimicrobial, disinfectant
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
  • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
  • A61B2017/1205—Introduction devices
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L2430/00—Materials or treatment for tissue regeneration
  • A61L2430/36—Materials or treatment for tissue regeneration for embolization or occlusion, e.g. vaso-occlusive compositions or devices

Definitions

• An aneurysm is a dilation of a blood vessel (similar to a balloon) that poses a risk to health from the potential for rupture, clotting, or dissecting.
• Rupture of an aneurysm in the brain causes stroke, and rapture of an aneurysm in the abdomen causes shock.
• Cerebral aneurysms are usually detected in patients as the result of a seizure or hemorrhage and can result in significant morbidity or mortality.
• vaso-occlusion devices are surgical implements or implants that are placed within the vasculature of the human body, typically via a catheter, either to block the flow of blood through a vessel making up that portion of the vasculature through the formation of an embolus or to form such an embolus within an aneurysm stemming from the vessel.
• vaso-occlusive device is a helical wire coil having windings which may be dimensioned to engage the walls of the vessels. (See, e.g., U.S. Patent No. 4,994,069 to Ritchart et al.)
• Other less stiff helically coiled devices have been described, as well as those involving woven braids.
• Liquid embolics such as cyanoacrylate glues and fibrin sealants, have also been used in animal and human subjects. See, e.g., Interventional Radiology, Dandlinger et al, ed., Thieme, N.Y., 1990:295-313; Suga et al. (1992) No Shinkei Geka 20(8):865-873; Moringlane et al. (1987) SwrgNewro/ 28(5):361-366; Moringlane et al. (1988) Ada Neurochir Suppl. (Wein) 43:193-197. Of these liquid embolics, only cyanoacrylate glues are currently available to neurosurgeons.
• cyanoacrylate treatments Herrera et al. (1999) NeurolMed Chir (Tokyo) 39(2):134-139) and the degradation product, formaldehyde, is highly toxic to the neighboring tissues. See, Vinters et al (1995) Neuroradiology 27:279-291.
• Another disadvantage of cyanoacrylate materials is that the polymer will adhere both to the blood vessel and to the tip of the catheter. Thus physicians must retract the catheter immediately after injection of the cyanoacrylate embolic material or risk adhesion of the cyanoacrylate and the catheter to the vessel.
• this invention includes novel methods of occluding a selected vessel using rapidly expanding materials not previously used for these purposes.
• the invention includes a method of occluding a selected site in a subject comprising accessing the selected site; and administering a rapidly expanding composition to said selected site, thereby occluding said site.
• the composition comprises at least one foam, for example polyurethane or a dehydrated foam (e.g., a dehydrated foam comprising collagen).
• the composition comprises two or more materials that rapidly expand upon contact with each other.
• any of the compositions for use in the methods described herein are rapidly hardening.
• the selected site is an aneurysm and the administering comprises extrusion from a catheter.
• the rapidly expanding composition may self-expand; expand upon contact with moisture; expand upon a decrease in pressure (e.g., upon extrusion from a delivery device such as a catheter); and/or expand upon contact with an additional material (e.g., where the contact is at the tip of the catheter).
• any of the methods described herein further comprise the step of administering one or more bioactive materials (e.g., cytokines; trace metals, antibiotics and combinations thereof), either before, after or concurrently with the composition.
• bioactive materials e.g., cytokines; trace metals, antibiotics and combinations thereof
• This invention involves a methods of occluding a selected vessel in a subject using a material (e.g., liquid or foam) that rapidly expands upon extrusion from a deployment mechanism and does not further expand over time.
• the material may include additives and/or fillers (such as radio-opaque additives and/or bioactive materials such as cytokines, growth factors, etc.) or the like.
• expansion refers to any increase in volume.
• rapidly expanding refers to any material that expands upon, for example extrusion, within a short period of time (on the order of seconds or less than a second) and does not further expand after this initial expansion over time.
• the term “hardening” or “solidifying” refers to any liquid or flowable material that forms a solid mass with a particular expanded volume, either over time, upon contact with another substance or upon application of energy.
• the term “rapidly hardening” refers to any of these materials that solidify in less than about one hour, preferably less than 5 minutes, and even more preferably, less than about 30 seconds.
• the rapidly expanding materials described herein are to be contrasted with materials that take on the order of hours or days to stop expanding and form clots with desirable strength.
• the methods described herein are suitable for both neurological, peripheral and cardiovascular applications as well as in other vessels such as in the Fallopian tubes and the like.
• any suitable rapidly expanding material can be used, so long as it is not harmful when implanted in the subject.
• the material will preferably have certain characteristics: (1) it should be flowable (e.g., liquid, paste or foam) at delivery; (2) it should expand upon extrusion from the deployment mechanism (e.g., catheter); (3) expansion upon extrusion should be immediate or virtually immediate, on the order to seconds or less than a second; (4) no expansion should occur after the initial expansion on extrusion; (5) hardening is ' preferably rapid, seconds or minutes rather than hours or days; (6) few or no toxic or otherwise harmful by-products should be released; and (7) the resultant expanded material must not significantly expand its volume after initial expansion.
• the rapidly expanding material is a single component material.
• single component materials are those that rapidly expand when released from a pressurized system or, alternatively, upon contact with moisture. Pressurized fluids expand upon exiting the neck of the catheter as they go from higher to lower pressure. Pressure differentials can range anywhere between 10 to 1,000 or more PSI.
• Silly StringTM expands upon release from a pressurized contained, and, after the initial expansion upon extrusion, does not further expand over time.
• the material also hardens virtually instantaneously upon extrusion.
• multi-component materials are used, so long as the expansion that occurs rapidly at the site of deployment does not continue over time.
• single component materials include those materials that rapidly expand upon contact with moisture, for example certain polyurethane foam materials (e.g., U.S. Patent No. 4,2724,250; and Lu et al. (2000) BioMaterials 21(15):1595-1605 describing porous poly(L-lactide acid foams); hydrophilic polymers as disclosed, for example, in U.S. Patent 5,162,430; hydrogel materials such as those described in Wake et al. (1995) Cell Transplantation 4(3):275-279, Wiese et al. (2001) J.
• a non-limiting example of material that rapidly expands upon contact with moisture is a dehydrated foam, for example a dehydrated foam containing collagen.
• Non-limiting examples of multi-component materials include calcium phosphate cements (see, e.g., U.S. Patent No. 6,159,655) made by mixing two more components into a flowable paste, which then subsequently expands and/or hardens and mixtures of any of any suitable single-component materials. Additionally, one or more of materials can also be used in various combinations.
• the rapidly expanding material is preferably in a fluid or foam state for delivery, for example for transport through the lumen of a catheter to the site to be occluded.
• Additional agents may be present to facilitate delivery of the rapidly expanding material, so long as the additional fluid is not harmful to the subject may be used.
• the rapidly expanding material can be dispersed in a water-blowing agent (see, e.g., U.S. Patent No. 6,211,257 and references cited therein).
• the rapidly expanding materials can be used alone or in combination with one or more implantable devices (e.g., vaso-occlusive devices, stents, filters, etc.), one or more additional bioactive materials or a combination of implantable devices and additional bioactive materials.
• implantable devices e.g., vaso-occlusive devices, stents, filters, etc.
• additional bioactive materials e.g., vaso-occlusive devices, stents, filters, etc.
• additional bioactive materials e.g., a combination of implantable devices and additional bioactive materials.
• bioactive refers to any agent that exhibits effects in vivo, for example a thrombotic agent, a therapeutic agent or the like.
• bioactive materials include cytokines; trace metals (e.g., copper); molecules that stabilize thrombus formation or inhibit clot lysis (e.g., proteins or functional fragments of proteins, including but not limited to Factor XIII, alpha 2 -antiplasmin, plasminogen activator inhibitor-1 (PAI-1)); antibiotics;
• cytokines which may be used alone or in combination in the practice of the present invention include, basic fibroblast growth factor (beta-FGF), platelet derived growth factor (PDGF), vascular endothelial growth factor (VEGF), transforming growth factor beta (TGF- ⁇ ) and the like.
• Cytokines are commercially available from several vendors such as, for example, Genzyme (Framingham, MA), Genentech (South San Francisco, CA), Amgen (Thousand Oaks, CA), R&D Systems and Immunex (Seattle, WA). Additionally, bioactive polypeptides can be synthesized recombinantly as the sequence of many of these molecules are also available, for example, from the GenBank database.
• bioactive materials useful in the practice of the invention can be readily determined by a skilled operator and it will be understood that any combination of materials, concentration or dosage can be used, so long as it is not harmful to the subject.
• the mechanism will be such as to be capable of being advanced entirely through the catheter to place implantable device at the target site but yet with a sufficient portion of the distal end of the delivery mechanism protruding from the distal end of the catheter to enable detachment of the implantable device.
• the delivery mechanism will normally about 100-200 cm in length, more normally 130-180 cm in length.
• the diameter of the delivery mechanism is usually in the range of 0.25 to about 0.90 mm.
• the rapidly expanding materials described herein are typically loaded into a carrier for introduction into the delivery catheter and introduced to the chosen site using the procedure outlined below.
• This procedure may be used in treating a variety of maladies.
• the aneurysm itself may be filled with the embolics (e.g., mechanical devices and/or rapidly expanding materials and bioactive materials) which cause formation of an emboli and, at some later time, is at least partially replaced by neovascularized collagenous material formed around the implanted devices.
• embolics e.g., mechanical devices and/or rapidly expanding materials and bioactive materials
• a selected site is reached through the vascular system using a collection of specifically chosen catheters and/or guide wires.
• Suitable catheters known to those of skill in the art and include flexible catheters (see, e.g., 6,165,163; 6,159,187; 6,090,099; and 4,739,768) and multi-lumen catheters (e.g., U.S. Patent Nos. 5,797,869 to Martin et al.; 4,636,346, to Gold et al.; 4,840,622, to Hardy; 4,863,442, to DeMello et al.; and 5,078,702, to Pomeranz).
• Catheters suitable for delivering materials that expand upon reduced pressure include those including pinch valves and/or other means for keeping a fluid under pressure within the confines of the catheter. (See, e.g., U.S. Patent No. 6,210,319 and U.S. Patent No. 6,210,392 and documents cited therein).
• a guiding catheter is then used to provide a safe passageway from the entry site to a region near the site to be treated.
• a guiding catheter would be chosen which would extend from the entry site at the femoral artery, up through the large arteries extending to the heart, around the heart through the aortic arch, and downstream through one of the arteries extending from the upper side of the aorta.
• a guidewire and neurovascular catheter as described herein are then placed through the guiding catheter. Once the distal end of the catheter is positioned at the site, often by locating its distal end through the use of radiopaque marker material and fluoroscopy, the catheter is cleared. For instance, if a guidewire has been used to position the catheter, it is withdrawn from the catheter and then the rapidly expanding material is advanced through the catheter.
• the rapidly expanding material and/or other materials is(are) advanced past the distal end of the catheter and positioned or extruded precisely at the desired treatment site where they rapidly expand to fill the target site.
• the order in which the components e.g., rapidly expanding material; vaso-occlusive member; and/or other bioactive materials
• the rapidly expanding material when used with an implantable device, it may be preferable to release the rapidly expanding material after the device is situated so that the fluid can penetrate in and around the device.

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Surgery (AREA)
• Veterinary Medicine (AREA)
• Public Health (AREA)
• General Health & Medical Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• Epidemiology (AREA)
• Heart & Thoracic Surgery (AREA)
• Vascular Medicine (AREA)
• Chemical & Material Sciences (AREA)
• Engineering & Computer Science (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Biomedical Technology (AREA)
• Reproductive Health (AREA)
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• Bioinformatics & Cheminformatics (AREA)
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• General Chemical & Material Sciences (AREA)
• Cardiology (AREA)
• Materials For Medical Uses (AREA)
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• Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
• Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

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• 2002
  • 2002-03-06 US US10/093,264 patent/US20030171773A1/en not_active Abandoned
• 2003
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  • 2003-03-06 WO PCT/US2003/006985 patent/WO2003075746A2/en not_active Ceased
  • 2003-03-06 CA CA002477256A patent/CA2477256A1/en not_active Abandoned
  • 2003-03-06 EP EP03713963A patent/EP1482858A4/en not_active Withdrawn
  • 2003-03-06 AU AU2003217985A patent/AU2003217985A1/en not_active Abandoned
• 2006
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