WO2003099370A2 - Solid embolic material with variable expansion - Google Patents
Solid embolic material with variable expansionInfo
- Publication number
- WO2003099370A2 WO2003099370A2 PCT/US2003/014217 US0314217W WO03099370A2 WO 2003099370 A2 WO2003099370 A2 WO 2003099370A2 US 0314217 W US0314217 W US 0314217W WO 03099370 A2 WO03099370 A2 WO 03099370A2
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- balloon
- embolic
- solid
- embolic material
- distal end
- Prior art date
Links
- 230000003073 embolic effect Effects 0.000 title claims abstract description 86
- 239000000463 material Substances 0.000 title claims abstract description 76
- 239000007787 solid Substances 0.000 title claims abstract description 54
- 239000007788 liquid Substances 0.000 claims abstract description 26
- 229920000642 polymer Polymers 0.000 claims description 23
- 239000012530 fluid Substances 0.000 claims description 18
- 239000003550 marker Substances 0.000 claims description 10
- 238000007789 sealing Methods 0.000 claims description 4
- 239000000126 substance Substances 0.000 claims description 4
- 229920001730 Moisture cure polyurethane Polymers 0.000 claims description 2
- 239000011877 solvent mixture Substances 0.000 claims description 2
- 239000011343 solid material Substances 0.000 claims 5
- 239000003999 initiator Substances 0.000 claims 1
- 230000007556 vascular defect Effects 0.000 abstract description 27
- 230000007547 defect Effects 0.000 abstract description 14
- 230000002792 vascular Effects 0.000 abstract description 8
- 239000000203 mixture Substances 0.000 description 11
- 238000010438 heat treatment Methods 0.000 description 8
- 238000002347 injection Methods 0.000 description 7
- 239000007924 injection Substances 0.000 description 7
- 239000002904 solvent Substances 0.000 description 7
- 238000000034 method Methods 0.000 description 6
- 206010002329 Aneurysm Diseases 0.000 description 5
- 229920001651 Cyanoacrylate Polymers 0.000 description 4
- 206010016717 Fistula Diseases 0.000 description 4
- 230000001070 adhesive effect Effects 0.000 description 4
- 230000036760 body temperature Effects 0.000 description 4
- 230000003890 fistula Effects 0.000 description 4
- BASFCYQUMIYNBI-UHFFFAOYSA-N platinum Chemical compound [Pt] BASFCYQUMIYNBI-UHFFFAOYSA-N 0.000 description 4
- -1 poly(vinyl acetate) Polymers 0.000 description 4
- 230000008569 process Effects 0.000 description 4
- MWCLLHOVUTZFKS-UHFFFAOYSA-N Methyl cyanoacrylate Chemical compound COC(=O)C(=C)C#N MWCLLHOVUTZFKS-UHFFFAOYSA-N 0.000 description 3
- 239000000853 adhesive Substances 0.000 description 3
- 239000003054 catalyst Substances 0.000 description 3
- 238000013461 design Methods 0.000 description 3
- 230000001788 irregular Effects 0.000 description 3
- 239000004014 plasticizer Substances 0.000 description 3
- 210000005166 vasculature Anatomy 0.000 description 3
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 2
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 2
- 239000000956 alloy Substances 0.000 description 2
- 229910045601 alloy Inorganic materials 0.000 description 2
- 239000003795 chemical substances by application Substances 0.000 description 2
- UHZZMRAGKVHANO-UHFFFAOYSA-M chlormequat chloride Chemical compound [Cl-].C[N+](C)(C)CCCl UHZZMRAGKVHANO-UHFFFAOYSA-M 0.000 description 2
- LZCLXQDLBQLTDK-UHFFFAOYSA-N ethyl 2-hydroxypropanoate Chemical compound CCOC(=O)C(C)O LZCLXQDLBQLTDK-UHFFFAOYSA-N 0.000 description 2
- 239000000499 gel Substances 0.000 description 2
- PCHJSUWPFVWCPO-UHFFFAOYSA-N gold Chemical compound [Au] PCHJSUWPFVWCPO-UHFFFAOYSA-N 0.000 description 2
- 229910052737 gold Inorganic materials 0.000 description 2
- 239000010931 gold Substances 0.000 description 2
- 238000011065 in-situ storage Methods 0.000 description 2
- 230000000977 initiatory effect Effects 0.000 description 2
- 229910052741 iridium Inorganic materials 0.000 description 2
- GKOZUEZYRPOHIO-UHFFFAOYSA-N iridium atom Chemical compound [Ir] GKOZUEZYRPOHIO-UHFFFAOYSA-N 0.000 description 2
- 229910052751 metal Inorganic materials 0.000 description 2
- 239000002184 metal Substances 0.000 description 2
- 229910052697 platinum Inorganic materials 0.000 description 2
- 238000006116 polymerization reaction Methods 0.000 description 2
- 230000010512 thermal transition Effects 0.000 description 2
- 238000012800 visualization Methods 0.000 description 2
- JOYRKODLDBILNP-UHFFFAOYSA-N Ethyl urethane Chemical compound CCOC(N)=O JOYRKODLDBILNP-UHFFFAOYSA-N 0.000 description 1
- 101000801619 Homo sapiens Long-chain-fatty-acid-CoA ligase ACSBG1 Proteins 0.000 description 1
- 102100033564 Long-chain-fatty-acid-CoA ligase ACSBG1 Human genes 0.000 description 1
- NIXOWILDQLNWCW-UHFFFAOYSA-N acrylic acid group Chemical group C(C=C)(=O)O NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 description 1
- 229920006243 acrylic copolymer Polymers 0.000 description 1
- 230000004913 activation Effects 0.000 description 1
- 125000000217 alkyl group Chemical group 0.000 description 1
- 235000010634 bubble gum Nutrition 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 239000011248 coating agent Substances 0.000 description 1
- 238000000576 coating method Methods 0.000 description 1
- 238000004891 communication Methods 0.000 description 1
- 238000010276 construction Methods 0.000 description 1
- 239000002872 contrast media Substances 0.000 description 1
- 229940039231 contrast media Drugs 0.000 description 1
- 238000001816 cooling Methods 0.000 description 1
- 229920001577 copolymer Polymers 0.000 description 1
- 229920006037 cross link polymer Polymers 0.000 description 1
- NLCKLZIHJQEMCU-UHFFFAOYSA-N cyano prop-2-enoate Chemical class C=CC(=O)OC#N NLCKLZIHJQEMCU-UHFFFAOYSA-N 0.000 description 1
- 235000014113 dietary fatty acids Nutrition 0.000 description 1
- 239000003822 epoxy resin Substances 0.000 description 1
- 229940116333 ethyl lactate Drugs 0.000 description 1
- 229930195729 fatty acid Natural products 0.000 description 1
- 239000000194 fatty acid Substances 0.000 description 1
- 238000002594 fluoroscopy Methods 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- LNEPOXFFQSENCJ-UHFFFAOYSA-N haloperidol Chemical compound C1CC(O)(C=2C=CC(Cl)=CC=2)CCN1CCCC(=O)C1=CC=C(F)C=C1 LNEPOXFFQSENCJ-UHFFFAOYSA-N 0.000 description 1
- 229920001903 high density polyethylene Polymers 0.000 description 1
- 229920006158 high molecular weight polymer Polymers 0.000 description 1
- 239000004700 high-density polyethylene Substances 0.000 description 1
- 125000001183 hydrocarbyl group Chemical group 0.000 description 1
- 239000000017 hydrogel Substances 0.000 description 1
- 238000001802 infusion Methods 0.000 description 1
- 230000007246 mechanism Effects 0.000 description 1
- 239000007769 metal material Substances 0.000 description 1
- 239000000178 monomer Substances 0.000 description 1
- 230000002093 peripheral effect Effects 0.000 description 1
- 239000004033 plastic Substances 0.000 description 1
- 229920003023 plastic Polymers 0.000 description 1
- 229920001482 poly(N-isopropylacrylamide) copolymer Polymers 0.000 description 1
- 229920000647 polyepoxide Polymers 0.000 description 1
- 229920001296 polysiloxane Polymers 0.000 description 1
- 239000004810 polytetrafluoroethylene Substances 0.000 description 1
- 229920001343 polytetrafluoroethylene Polymers 0.000 description 1
- 229920002689 polyvinyl acetate Polymers 0.000 description 1
- 239000011118 polyvinyl acetate Substances 0.000 description 1
- 230000002787 reinforcement Effects 0.000 description 1
- 238000009877 rendering Methods 0.000 description 1
- 230000004044 response Effects 0.000 description 1
- 238000007711 solidification Methods 0.000 description 1
- 230000008023 solidification Effects 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 230000008961 swelling Effects 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 239000003106 tissue adhesive Substances 0.000 description 1
- UFTFJSFQGQCHQW-UHFFFAOYSA-N triformin Chemical compound O=COCC(OC=O)COC=O UFTFJSFQGQCHQW-UHFFFAOYSA-N 0.000 description 1
- 238000007794 visualization technique Methods 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- 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
- A61B17/12195—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 comprising a curable material
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
- A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
- 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, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/12136—Balloons
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/12181—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
- A61B17/12186—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 liquid materials adapted to be injected
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B2017/1205—Introduction devices
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B2017/1205—Introduction devices
- A61B2017/12054—Details concerning the detachment of the occluding device from the introduction device
- A61B2017/12063—Details concerning the detachment of the occluding device from the introduction device electrolytically detachable
Definitions
- the present invention generally pertains to embolic balloons and delivery systems.
- the present invention relates to embolic balloons delivered by intravascular microcatheters to vascular defects.
- vascular defects such as aneurysms and fistulas, which commonly occur in the neurovasculature
- a microcatheter is navigated through the patient's vasculature until a distal end of the microcatheter is adjacent the defect.
- An embolic material is then delivered through the microcatheter and into the vascular defect, to thereby fill and seal- off the defect.
- embolic coils, balloons or other embolic devices which are typically symmetrically shaped.
- liquid embolic materials tend to fill irregularly shaped and asymmetrical volumes more precisely and completely, liquid embolic materials are often difficult to deliver through a microcatheter and are often difficult to contain within the defect. Accordingly, there is a substantial need for an embolic material and delivery system that is capable of filling an asymmetrical and irregularly shaped vascular defect, that is easy to deliver with a microcatheter, and that is easy to contain within the defect. There is also an ongoing need for improved embolic balloons and associated delivery systems. In particular, there is a need for detachable embolic balloons that may be easily delivered and maintained in the vascular defect so as to not protrude into the native vascular lumen.
- the invention provides, in an exemplary non-limiting embodiment, a solid embolic material that is capable of filling irregularly shaped and asymmetrical vascular defects in a controlled and predictable manner, without the difficulties associated with delivery of embolic material through a microcatheter and containment of embolic material in a defect.
- the solid embolic material of the present invention may be inflated with a liquid (e.g., liquid embolic material) to further engage the internal walls of the defect and to more completely fill the irregularly shaped volume of the defect.
- the invention also provides, in another exemplary non-limiting embodiment, a detachable embolic balloon and associated delivery system.
- the detachable embolic balloon in this embodiment may be filled with a curable liquid wherein the curing process may be aided by thermal means.
- the detachable embolic balloon may optionally incorporate a check valve for maintaining the liquid in the balloon prior to curing and/or a multi-leaflet covering to prevent the balloon from expanding into the native or parent vascular lumen.
- Figure 1 illustrates a microcatheter, a syringe containing a solid embolic material therein for placement into a distal end of the microcatheter, and a syringe containing a fluid for injection into a proximal end of the catheter;
- Figures 2A and 2B illustrate alternative methods of containing the solid embolic material, and loading the solid embolic material into the distal end of the microcatheter;
- Figures 3 A — 3C schematically illustrate the delivery of the solid embolic material into an aneurysm having an irregular shape
- Figures 4A — 4D schematically illustrate a first embodiment of a detachable embolic balloon and delivery system
- Figures 5 A — 5D schematically illustrate a second embodiment of a detachable embolic balloon and delivery system.
- FIG. 1 illustrates a microcatheter 10, a syringe 40, and a syringe 70.
- Syringe 40 contains a solid embolic material 50 which may be disposed or injected into the catheter 10 as indicated by arrow 60.
- Syringe 70 contains a fluid 80 (e.g., radiopaque saline solution or liquid embolic agent) for injection into the catheter 10 as indicated by arrow 90.
- fluid 80 e.g., radiopaque saline solution or liquid embolic agent
- Microcatheter 10 may be used to deliver the solid embolic material 50 to a vascular defect such as an aneurysm or fistula having an internal wall defining an internal volume therein.
- the solid embolic material 50 is particularly suitable for filling internal volumes that are irregular in shape and eccentric relative to the neck or opening to the native vascular lumen.
- Intravascular catheter 10 is sized (length and diameter) and designed (pushability and trackability) to navigate a patient's vascular system to access vascular defects in the neurovasculature, coronary vasculature and/or peripheral vasculature.
- Intravascular catheter 10 may include one or more lumens and may be designed to accommodate a guide wire (not shown) and/or to incorporate a distally disposed inflatable balloon (not shown). Although a single lumen intravascular microcatheter 10 is illustrated, those skilled in the art will recognize that a wide variety of intravascular catheters may be used to deliver solid embolic material 50 to a vascular defect.
- Intravascular microcatheter 10 includes an elongate shaft 12 having proximal end 14 and a distal end 16.
- a hub assembly 18 is connected to the proximal end 14 of the elongate shaft 12.
- a lumen extends through the hub assembly 18 and through the length of the shaft 12 to a distal- facing opening (not visible) in the distal end 16 of the shaft 12.
- Hub assembly 18 facilitates connection to ancillary devices such as syringe 70 for the injection or infusion of fluids 80 such as contrast media (e.g., radiopaque dye and saline solution) and liquid embolic agents (e.g., cyanoacrylate) into the lumen and out the opening at the distal end 16.
- fluids 80 such as contrast media (e.g., radiopaque dye and saline solution) and liquid embolic agents (e.g., cyanoacrylate) into the lumen and out the opening at the distal end 16.
- the distal end 16 may be rendered radiopaque by utilizing radiopaque loading in the polymers of the distal end 16 of the shaft 12 or by utilizing a radiopaque marker band 20 disposed thereon. Rendering the distal end 16 radiopaque allows the tip to be precisely navigated utilizing x-ray radiographic techniques.
- Solid embolic material 50 defines an initially solid volume when disposed in syringe 40 and when disposed in the lumen at the distal end 16 of the shaft 12. Sufficient solid embolic material is disposed in the lumen of the catheter 10 to fill the internal volume or lining of the targeted vascular defect. Solid embolic material 50 is readily stretchable, viscid and self-sealing such that the material is able to expand upon injection of a fluid into the solid volume thereof. Upon injection of a fluid into the solid volume, the solid embolic material 50 expands to create an internal volume which self-seals and retains the fluid therein.
- the solid embolic material 50 Upon expansion, the solid embolic material 50 is not elastically biased to its original state, but rather tends to assume and hold its expanded state with little or no pressure maintained in the volume created therein. To this end, the solid embolic material 50 is much like bubble-gum in its behavior, albeit for substantially different applications requiring substantially different compositions and designs.
- the fluid 80 used to inflate the solid embolic material 50 may comprise a radiopaque liquid or a liquid embolic material (e.g., cyanoacrylate), for example.
- the solid embolic material 50 facilitates containment of the liquid embolic material in the vascular defect, and the liquid embolic material may be selected to solidify after injection into the solid embolic material 50, in order to assist in-sealing the inflated internal volume of the solid embolic material 50.
- a pressurized fluid source such as a syringe 70 may be connected to the hub assembly 18 of the catheter 10.
- Such a device 70 may also be used to pressurize the lumen in the catheter 10 to urge the solid embolic material 50 out of the distal end 16 of the catheter 10 and into the vascular defect.
- the solid embolic material 50 preferably has relatively high cohesivity and simultaneously is in a state capable of plastic deformation at low pressures.
- the solid embolic material 50 preferably has little or no elastic restoring force that will cause the material 50 to contract after pressure is released subsequent to inflation within the defect 100.
- the solid embolic material 50 will preferably withstand 1000% elongation or more, for example, during inflation. Polymer based materials are probably the best candidates for this application. However there are a number of material classes that might be used, and within each class, there are a large number of possible formulations that may have suitable properties. Accordingly, although specific examples are given, the examples are illustrative only.
- the solid embolic material 50 may comprise a medium to high molecular weight polymer in a semi-swollen or highly plasticized state.
- a polymer comprises poly(vinyl acetate) dissolved in ethanol/ethyl lactate.
- Another example of such a polymer comprises alkyl methacrylate (the alkyl side- chain being greater than C4) dissolved in a plasticizer (e.g., fatty acid ester, di-alkyl citrate, or triglyceride).
- a plasticizer e.g., fatty acid ester, di-alkyl citrate, or triglyceride.
- the types and concentrations of the polymer/solvent mixture may be selected to optimize the desired characteristics.
- one of the components of the polymer solution/mixture may melt at a temperature slightly above body temperature and act as a plasticizer for the other component.
- a localized heat source may be used to heat the first component to a temperature above body temperature (37C).
- polymers suitable for the solid embolic material 50 include polymers that can be transformed to a low modulus state in-situ by small localized temperature changes.
- examples of such polymers include non-cross linked polymers having semi-crystalline and amorphous phases (or possessing discrete liquid-crystalline phases) which have first or second order thermal transitions slightly above maximum body temperature (42C), such as long hydrocarbon side-chain acrylic copolymers.
- Such a polymer may utilize localized heating preferably during inflation and may incorporate tissue adhesive properties when heated.
- Such polymers may utilize localized cooling during inflation which causes the polymer to change from a solid or dense gel at body temperature to a swollen or loose hydrogel material capable of deformation at lower temperatures.
- a mixture of a polymer and a solvent it may be important to ensure that the polymer remains mixed with the solvent until the time of use, in order for the solid embolic material 50 to retain its desired characteristics.
- the polymer and solvent may be kept in separate containers and manually mixed just prior to use, using a syringe 40 to inject the mixture into the distal end 16 of the catheter 10 as shown in Figure 1.
- a container 110 may contain a pre-mix of the polymer/solvent which may then be directly injected into the distal end 16 of the catheter 10 as shown in Figure 2 A.
- the container 110 may be rolled, squeezed or shaken to ensure a homogenous mix, opened by removal of a cap (not shown), placed over the distal end 16 of the catheter 10, and manually squeezed (as indicated by arrows 112) to inject the mixture therein (as indicated by arrow 114).
- a short tubular container 120 containing a pre-mix of the polymer/solvent may be attached to the distal end 16 of the catheter 10 as shown in Figure 2B.
- the container 120 has a sealed distal end 122 that may be cut to provide an opening, and a proximal end 124 sealed by cover 126.
- the proximal end 124 is sized to snuggly fit over and attach to the distal end 16 of the catheter 10.
- the container 120 may be rolled, squeezed or shaken to ensure a homogenous mix, opened by removal of the cover 126 (as indicated by arrow 125), attached to the distal end 16 of the catheter 10 by sliding the proximal end 124 thereon (as indicated by arrow 127), and the distal end 122 cut (as indicated by arrow and dashed line 129) to provide a distal opening.
- the solid embolic material 50 may be used to treat a vascular defect 100 such as an aneurysm or fistula.
- the vascular defect 100 includes an internal wall 102 defining an internal volume 104.
- the solid embolic material 50 may also be used to occlude vessels for therapeutic purposes.
- the catheter 10 may be navigated through a patient's vascular system until the distal end 16 is disposed adjacent the opening 106 to the vascular defect 100 as seen in Figure 3 A.
- the solid embolic material 50 may then be urged from the lumen at the distal end
- the solid embolic material 50 may then be further urged into the vascular defect until the solid embolic material substantially conforms to the internal wall 102 and substantially fills the internal volume 104 as seen in Figure 3C, despite the irregular shape of the wall 102 and volume 104. This may be accomplished by applying more fluid pressure in the catheter lumen proximal of the solid embolic material 50 using syringe 70 connected to the hub assembly 18, to cause the fluid 80 to be injected into the solid embolic material 50 and to inflate the same.
- the solid embolic material 50 may be inflated to varying degrees to conform to vascular defects 100 of varying size and shape.
- the solid embolic material 50 in the defect 100 may be detached from the distal end 16 of the catheter 10 (and any solid embolic material 50 remaining in the distal end 16) by rotating the catheter 10 and/or by pulling the catheter 10 proximally.
- catheter 200 includes an elongate shaft 212 having a proximal end (not visible) and a distal end.
- catheter 200 also includes a detachable balloon 214 having a proximal end thereof releasably connected to the distal end of the shaft 212.
- the detachable balloon 214 may comprise, for example, any of the materials discussed previously with reference to solid embolic material 50.
- the shaft 212 may include a guide wire lumen lateral attachment 216 which defines a guide wire lumen (not visible) extending therethrough to slidably accommodate conventional guide wire 400.
- the side attachment 216 may comprise, for example, a short tube connected to the shaft 212 by adhesive, thermal bond, and/or a heat shrink sleeve.
- the shaft 212 may also include a radiopaque marker band 218 connected to its distal end. Radiopaque marker band 218 may comprise, for example, a band of dense metal such as platinum, gold, iridium, or an alloy thereof.
- the elongate shaft may comprise an outer tubular layer 222 surrounding an inner tubular layer 224 which extends distally beyond the outer layer 222.
- a reinforcement layer such as a metallic or polymeric coil or braid may be disposed between the inner layer 224 and the outer layer 22 to enhance navigational performance of the shaft 212.
- the marker band 218 may be disposed on the inner layer 224 distal of the outer layer 22 such that the outside diameter of the marker band 218 is flush with or does not exceed the outside diameter of the outer layer 222.
- the proximal end of the balloon may include a radiopaque marker coil 226 molded into the wall of the proximal end of the balloon 214 or connected thereto by other means (e.g., adhesive, thermal bonding, etc.)
- the radiopaque marker 226 may comprise, for example, a wound wire coil of a dense metal such as platinum, gold, iridium, or an alloy thereof. Together with radiopaque marker band 218, radiopaque marker coil 226 facilitates radiographic visualization during deployment of the detachable balloon 214.
- the inner tubular layer 224 defines a lumen 211 which extends through the full length of the shaft 212 and is in fluid communication with the interior 213 of the balloon 214 via optional check valve 228.
- Check valve 228 may comprise a duck-bill type or flapper type valve that permits fluid flow in only the distal direction. As will be described in more detail hereinafter, check valve 228 helps retain the inflation liquid in the interior 213 of the balloon 214 to allow the inflation liquid to cure or to otherwise permit detachment of the balloon 214 from the distal end of the shaft 212 after filling the balloon 214 with a liquid. Detachment of the balloon 214 from the distal end of the shaft 212 may be accomplished with an electrolytic detachment system or with a break-away bond as described in more detail below.
- the balloon 214 may comprise a material that is highly compliant and flexible at low inflation pressures to permit low pressure expansion (e.g., less than 2 ATM), the connection between the distal end of the shaft 212 and the proximal end of the balloon 214 does not necessarily need to withstand high inflation pressures (e.g., greater than 15 ATM).
- high inflation pressures e.g., greater than 15 ATM.
- the connection between the distal end of the shaft 212 and the proximal end of the balloon 214 may be made detachable by a weak chemical and/or mechanical bond, for example, that may be broken upon the application of torsional and/or longitudinal forces.
- twisting and pulling the proximal end of the shaft 212 may be utilized as a means to break the bond and detach the balloon 214 from the shaft 212.
- a relatively weak bond may be provided, for example, by utilizing a relatively lubricious polymer (e.g., PTFE or HDPE without surface activation) for the inner tubular layer 224 and a conventional biocompatible adhesive such as cyanoacrylate to bond the inner tube 224 to the proximal end of the balloon 214.
- the interior 213 of the balloon 214 may be inflated or otherwise filled with a curable liquid such as acrylic monomers, urethane pre-polymers, epoxy resins, cyanoacrylates, silicones, or similar material.
- a curable liquid such as acrylic monomers, urethane pre-polymers, epoxy resins, cyanoacrylates, silicones, or similar material.
- the polymerization or curing process of such materials or a thermal transition of such materials may be accelerated or induced by heat.
- a heating device 230 may be introduced through the lumen 211 of the shaft 212 and into the interior 213 of the balloon 214 to supply thermal energy to the curable liquid disposed in the interior 213 of the balloon 214 as shown in Figure 4C.
- the heating device 230 may also be used to heat the balloon 214 if the balloon 214 is formed of a thermally responsive material.
- the heating device 230 may comprise, for example, a hollow guide wire type shaft 234 having a distally disposed heating element 232.
- the heating element 232 may comprise an electrical resistive heating coil powered via leads (not shown) extending through the shaft 234 to a power source (not shown).
- the polymerization or curing process may be induced or accelerated by contact with an initiating chemical component or catalyst which may be present within the balloon 214 as a coating on the inside surface of the balloon 214 or as a blend contained in the balloon material.
- the initiating chemical component or catalyst may be delivered into the balloon 214 via a separate lumen in the shaft 212 or via a separate tube (e.g. hypotube) advanced through the shaft 212.
- the catheter 200 is navigated through the patient's vascular system utilizing radiographic visualization or other visualization techniques until the balloon 214 is disposed adjacent the vascular defect. The balloon 214 is then advanced or otherwise urged into the vascular defect.
- the interior 213 of the balloon 214 is then inflated with a curable liquid via lumen 211 of the shaft 212.
- the check valve 228 permits the liquid to enter the interior 213 of the balloon 214 but prevents substantial egress of the liquid thereout.
- the balloon 214 may then be inflated until the perimeter of the balloon 214 substantially conforms to the contours of the defect.
- the liquid in the balloon is allowed to cure, with or without the use of a catalyst or an accelerator.
- a heating device 230 may be advanced into the interior 213 of the balloon 214 and activated to initiate and/or accelerate the solidification process of the curable liquid, or to heat the balloon material.
- the catheter shaft 212 may be released from the balloon 214 by an externally activated detachment mechanism or by twisting and pulling, for example, thus leaving the detachable balloon 214 and associated components 226/228 in the vascular defect.
- FIGS 5A — 5D schematically illustrate a distal portion of a detachable embolic balloon catheter 210, which is substantially the same in design and function as catheter 200 except as described herein and illustrated in the drawings.
- a plurality of leaflets 242 e.g., 2, 3, 4, or more
- the proximal ends of the leaflets 242 may be hinged and are attached to the proximal end of the balloon 214.
- the distal ends of the leaflets 242 collectively meet adjacent the distal apex of the balloon 214.
- the leaflets 242 may be formed of a flexible polymeric or metallic material which is generally more rigid than the material of the balloon 214.
- the leaflets 242 may have a rectangular cross-section with a convex exterior surface, a concave interior surface, and a distal inward taper to conform to the profile of the balloon 214.
- the leaflets 242 separate and expand about hinge points at their respective proximal ends as shown in Figure 5C. Upon further expansion, the leaflets 242 and the balloon 214 conform to the inside surface of the defect as shown in Figure 5D. Because the leaflets 242 are relatively more rigid than the balloon 214, and because the leaflets 242 extend across the opening to the vascular defect, the leaflets 242 prevent the balloon 214 from expanding into the native vascular lumen to thereby confine the balloon 214 within the interior of the vascular defect.
- catheter 210 is otherwise the same as catheter 200 described previously.
Abstract
Description
Claims
Priority Applications (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP03722024A EP1507482B1 (en) | 2002-05-24 | 2003-05-05 | Solid embolic material with variable expansion |
AT03722024T ATE513517T1 (en) | 2002-05-24 | 2003-05-05 | SOLID MATERIAL WITH VARIABLE SPREADING FORCE TO CAUSE AN EMBOLY |
CA2483823A CA2483823C (en) | 2002-05-24 | 2003-05-05 | Solid embolic material with variable expansion |
AU2003225302A AU2003225302A1 (en) | 2002-05-24 | 2003-05-05 | Solid embolic material with variable expansion |
JP2004506893A JP4580232B2 (en) | 2002-05-24 | 2003-05-05 | Solid phase embolic material with variable expansion |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10/155,563 | 2002-05-24 | ||
US10/155,563 US7338511B2 (en) | 2002-05-24 | 2002-05-24 | Solid embolic material with variable expansion |
Publications (2)
Publication Number | Publication Date |
---|---|
WO2003099370A2 true WO2003099370A2 (en) | 2003-12-04 |
WO2003099370A3 WO2003099370A3 (en) | 2004-03-18 |
Family
ID=29549100
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US2003/014217 WO2003099370A2 (en) | 2002-05-24 | 2003-05-05 | Solid embolic material with variable expansion |
Country Status (7)
Country | Link |
---|---|
US (1) | US7338511B2 (en) |
EP (1) | EP1507482B1 (en) |
JP (1) | JP4580232B2 (en) |
AT (1) | ATE513517T1 (en) |
AU (1) | AU2003225302A1 (en) |
CA (1) | CA2483823C (en) |
WO (1) | WO2003099370A2 (en) |
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---|---|---|---|---|
US9050095B2 (en) | 2004-09-22 | 2015-06-09 | Covidien Lp | Medical implant |
US10335155B2 (en) | 2011-11-30 | 2019-07-02 | Covidien Lp | Positioning and detaching implants |
US10893868B2 (en) | 2012-01-20 | 2021-01-19 | Covidien Lp | Aneurysm treatment coils |
US9687245B2 (en) | 2012-03-23 | 2017-06-27 | Covidien Lp | Occlusive devices and methods of use |
US9713475B2 (en) | 2014-04-18 | 2017-07-25 | Covidien Lp | Embolic medical devices |
Also Published As
Publication number | Publication date |
---|---|
ATE513517T1 (en) | 2011-07-15 |
EP1507482B1 (en) | 2011-06-22 |
JP4580232B2 (en) | 2010-11-10 |
US20030220666A1 (en) | 2003-11-27 |
US7338511B2 (en) | 2008-03-04 |
EP1507482A2 (en) | 2005-02-23 |
JP2005526577A (en) | 2005-09-08 |
AU2003225302A8 (en) | 2003-12-12 |
CA2483823A1 (en) | 2003-12-04 |
CA2483823C (en) | 2011-02-15 |
AU2003225302A1 (en) | 2003-12-12 |
WO2003099370A3 (en) | 2004-03-18 |
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