US20130018414A1 - Devices, Systems and Methods for Closure of Cardiac Openings - Google Patents
Devices, Systems and Methods for Closure of Cardiac Openings Download PDFInfo
- Publication number
- US20130018414A1 US20130018414A1 US13/609,129 US201213609129A US2013018414A1 US 20130018414 A1 US20130018414 A1 US 20130018414A1 US 201213609129 A US201213609129 A US 201213609129A US 2013018414 A1 US2013018414 A1 US 2013018414A1
- Authority
- US
- United States
- Prior art keywords
- balloon
- adhesive
- cardiac opening
- closure device
- closure
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00491—Surgical glue applicators
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/14—Probes or electrodes therefor
- A61B18/1477—Needle-like probes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
-
- 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
- A61B17/12122—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder within the heart
-
- 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
-
- 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
- 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
- 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
- A61B17/08—Wound clamps or clips, i.e. not or only partly penetrating the tissue ; Devices for bringing together the edges of a wound
- A61B17/085—Wound clamps or clips, i.e. not or only partly penetrating the tissue ; Devices for bringing together the edges of a wound with adhesive layer
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
- A61B2017/00238—Type of minimally invasive operation
- A61B2017/00243—Type of minimally invasive operation cardiac
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00491—Surgical glue applicators
- A61B2017/005—Surgical glue applicators hardenable using external energy source, e.g. laser, ultrasound
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00491—Surgical glue applicators
- A61B2017/00504—Tissue welding
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00491—Surgical glue applicators
- A61B2017/00513—Tissue soldering
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00535—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated
- A61B2017/00557—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated inflatable
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00592—Elastic or resilient implements
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00606—Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
- A61B2017/0061—Implements located only on one side of the opening
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00623—Introducing or retrieving devices therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00632—Occluding a cavity, i.e. closing a blind opening
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00831—Material properties
- A61B2017/00867—Material properties shape memory effect
Definitions
- the invention generally relates to devices, systems, and related methods for closing cardiac openings. More particularly, the invention features devices, systems, and related methods for the percutaneous transluminal closure of patent foramen ovales and left atrial appendages.
- the human heart is divided into four compartments or chambers.
- the left and right atria are located in the upper portion of the heart and the left and right ventricles are located in the lower portion of the heart.
- the left and right atria are separated from each other by a muscular wall, the intraatrial septum, while the ventricles are separated by the intraventricular septum.
- Either congenitally or by acquisition, abnormal openings; holes, or shunts can occur between the chambers of the heart or the great vessels, causing blood to inappropriately flow therethrough.
- Such deformities are usually congenital and originate during fetal life when the heart forms from a folded tube into a four chambered, two-unit system.
- the septal deformities result from the incomplete formation of the septum, or muscular wall, between the chambers of the heart and can cause significant problems.
- septal deformity or defect is a persistent, one-way, usually flap-like opening in the wall between the right atrium and left atrium of the heart. Since left atrial pressure is normally higher than right atrial pressure, the flap typically stays closed. Under certain conditions, however, right atrial pressure exceeds left atrial pressure, creating the possibility for right to left shunting that can allow blood clots to enter the systemic circulation. This is particularly problematic for patients who are prone to forming venous thrombus, such as those with deep vein thrombosis or clotting abnormalities.
- Atrial arrhythmias i.e., abnormal heart rhythms which can cause the heart to pump less effectively.
- atrial arrhythmias i.e., abnormal heart rhythms which can cause the heart to pump less effectively.
- atrial fibrillation the two upper chambers of the heart (i.e., the left atria and the right atria), quiver instead of beating effectively.
- the atria do not beat and empty cleanly during atrial fibrillation, blood can stagnate on the walls and form clots that can then pass through the heart and into the brain, causing a stroke or a transient ischemic attack.
- These clots typically form in a cul-de-sac in the heart called the left atrial appendage due to its tendency to have low or stagnant flow.
- Nonsurgical closure of a patent foramen ovale and similar cardiac openings such as an atrial septal defect or a ventricular septal defect, and obliteration' of a left atrial appendage can be achieved using a variety of mechanical closure devices.
- These closure devices typically consist of a metallic structural framework with a scaffold material attached thereto.
- Currently available closure devices are often complex to manufacture, are inconsistent in performance, require a technically complex implantation procedure, lack anatomic conformability, and lead to complications (e.g., thrombus formation, chronic inflammation, residual leaks, perforations, fractures, and conduction system disturbances).
- Improved devices, systems, and related methods for closing cardiac openings such as, for example, a patent foramen ovale, and for obliterating cardiac cul-de-sacs, such as, for example, a left atrial appendage, are, therefore, needed.
- a device of the invention may include, for example, a patch with an adhesive and/or a removable frame.
- the patch can be placed across a cardiac opening, such as a patent foramen ovale or a left atrial appendage, to substantially occlude the cardiac opening.
- the device includes a U-shaped patch, together with an adhesive, that is specifically configured for attachment to a septum secundum and closure of a patent foramen ovale.
- a compound may be used to assist the device in closing, or may be used on its own to close, a cardiac opening.
- a compound that includes an adhesive and a plurality of composite particles disposed within the adhesive may be used in that regard.
- the plurality of composite particles disposed within the adhesive expand upon contact with blood and/or water, thereby locking the compound into place in the cardiac opening to substantially occlude the cardiac opening.
- the invention provides a closure device for percutaneous transvascular closure of a cardiac opening.
- the closure device includes a patch, an adhesive coated on the patch, and at least one hollow channel enclosed within the patch.
- the patch may include a bioresorbable material and the adhesive may be a light activated adhesive, such as, for example, an adhesive curable with ultraviolet light.
- the hollow channel enclosed within the patch may, for its part, be a conduit for light.
- the closure device may further include a fiber optic cable, and/or a removable frame, enclosed within the hollow channel.
- the closure device includes a divider that has first and second surfaces. The first surface is coupled to the adhesive and the second surface is coated with a primer.
- the invention in another aspect, relates to a method for percutaneous transluminal closure of a cardiac opening in a patient.
- the method includes inserting a closure device as described above into a heart of the patient and positioning the closure device across the cardiac opening to substantially occlude the cardiac opening.
- positioning the closure device across the cardiac opening includes coupling the closure device to a tissue surface of the patient proximate the cardiac opening.
- the cardiac opening may be, for example, a patent foramen ovale or a left atrial appendage.
- Coupling the closure device to the tissue surface may include providing light to the hollow channel enclosed within the patch and activating the adhesive coated on the patch with the provided light.
- coupling the closure device to the tissue surface includes applying a primer to the tissue surface.
- the invention provides a closure device for percutaneous transluminal closure of a cardiac opening.
- the closure device includes a patch, at least one hollow channel enclosed within the patch, and a removable frame enclosed within the hollow channel.
- the patch is made from a collagen material.
- the frame is constructed from a shape memory alloy, such as, for example, nitinol.
- the invention in still another aspect, relates to a method for percutaneous transluminal closure of a cardiac opening in a patient.
- the method includes inserting a closure device as immediately described above into a heart of the patient and positioning the closure device across the cardiac opening to substantially occlude the cardiac opening.
- positioning the closure device across the cardiac opening includes coupling the closure device to a tissue surface of the patient proximate the cardiac opening.
- the cardiac opening may be, for example, a patent foramen ovale or a left atrial appendage.
- coupling the closure device to the tissue surface includes thermally welding the closure device to the tissue surface.
- the frame of the closure device is removed from within the hollow channel after the closure device is thermally welded to the tissue surface.
- the invention provides a closure device for percutaneous transluminal closure of a cardiac opening.
- the closure device includes a housing, a releasable patch coupled to the housing, and an adhesive coated on the releasable patch.
- the housing is substantially conically shaped.
- the releasable patch includes a bioresorbable material.
- the adhesive may be a light activated adhesive, such as, for example, an adhesive curable with ultraviolet light.
- the closure device includes a light source enclosed within the housing. The light source may be, for example, a light bulb or a fiber optic cable.
- the closure device includes a divider that has first and second surfaces. The first surface is coupled to the adhesive and the second surface is coated with a primer.
- the invention in yet another aspect, relates to a method for percutaneous transluminal closure of a cardiac opening in a patient.
- the method includes inserting a closure device as immediately described above into a heart of the patient and positioning the releasable patch of the closure device across the cardiac opening to substantially occlude the cardiac opening.
- positioning the releasable patch of the closure device across the cardiac opening includes coupling the releasable patch to a tissue surface of the patient proximate the cardiac opening.
- the cardiac opening may be, for example, a patent foramen ovale or a left atrial appendage.
- Coupling the releasable patch of the closure device to the tissue surface may include providing a light source emitting light within the housing and activating the adhesive coated on the releasable patch with the emitted light.
- coupling the releasable patch to the tissue surface includes applying a primer to the tissue surface.
- coupling the releasable patch to the tissue surface includes separating the releasable patch from the housing.
- the invention provides a closure device for percutaneous transvascular closure of a patent foramen ovale.
- the closure device includes a U-shaped patch configured for attachment to a septum secundum and an adhesive coated on the U-shaped patch.
- a substance for stimulating tissue in-growth into the closure device is coated on the U-shaped patch.
- the substance may be, for example, a growth factor, a pharmacological agent to stimulate tissue growth, an irritant to encourage an inflammatory response, cells, or genes.
- a substance for increasing endothelization, or, alternatively, a substance for decreasing thrombogenicity, such as, for example, heparin is coated on the U-shaped patch.
- the closure device includes at least one barrier coupled to the U-shaped patch.
- the barrier may be a right atrial barrier for blocking an opening to the patent foramen ovale from the right atrium, or, alternatively, the barrier may be a left atrial barrier for blocking an opening to the patent foramen ovale from the left atrium.
- the U-shaped patch may include a biological material, a bioresorable material, a synthetic material, a polymeric material, a shape memory material, and/or a metallic mesh material.
- the adhesive may be, for example, cyanoacrylate and/or a fibrin based adhesive.
- the invention provides a method for percutaneous transluminal closure of a patent foramen ovale in a patient.
- the method includes inserting a closure device into a heart of the patient and coupling the closure device to the septum secundum to substantially occlude the patent foramen ovale.
- the closure device includes a U-shaped patch configured for attachment to a septum secundum and an adhesive coated on the U-shaped patch.
- coupling the closure device to the septum secundum includes gluing the closure device to the septum secundum.
- the invention in another aspect, relates to a compound for percutaneous transluminal closure of a cardiac opening.
- the compound includes an adhesive and a plurality of composite particles disposed within the adhesive.
- the composite particles are capable of expansion upon contact with blood and/or water.
- the adhesive is a fibrin based adhesive.
- the composite particles may be, for example, gelatin particles, biological particles, bioresorbable particles, and/or foam particles.
- the invention provides a method for percutaneous transluminal closure of a cardiac opening in a patient.
- the method includes providing a compound as described above and injecting the compound into the cardiac opening to substantially occlude the cardiac opening.
- the method further includes positioning a patch or a barrier across an end of the cardiac opening, which may be, for example, a patent foramen ovale or a left atrial appendage.
- a device of the invention may further include specially designed balloons together with adhesives and/or substances for stimulating tissue growth coated on, or contained within, the specially designed balloons.
- the specially designed balloons ensure that the adhesives are only exposed once the balloons are located within the cardiac openings.
- the adhesives are exposed only to the tissue surface of the cardiac openings and not to a patient's blood prior to locating the balloons within the cardiac openings. By minimizing the exposure of the adhesives to blood, the risk of thrombus formation is reduced.
- closure systems employ one or more locators for initially locating the cardiac openings and then properly positioning the balloons of the invention within the cardiac openings. Knowing that a balloon is properly positioned within a cardiac opening allows a physician to release the adhesive contained within the balloon at the appropriate time. As such, the risk of exposing the adhesive prior to locating the balloon within the cardiac opening, and the consequent risk of thrombus formation, is again reduced.
- the invention provides a closure device for percutaneous transluminal closure of a cardiac opening.
- the closure device includes a balloon, which has an outer surface, and an adhesive.
- the balloon is inflatable between a deflated state and an inflated state. In the deflated state, the outer surface of the balloon involutes to form a cavity and the adhesive is coated on a surface of the cavity. In the inflated state, the cavity unfolds to form the outer surface of the balloon and the adhesive is coated on the outer surface of the balloon.
- the cavity is formed around a mid-portion of the balloon, which may be tubularly-shaped.
- the closure device further includes a substance for stimulating tissue growth. In the deflated state of the balloon, the growth substance is coated on the surface of the cavity. In the inflated state of the balloon, the growth substance is coated on the outer surface of the balloon.
- the invention in another aspect, relates to a method for percutaneous transluminal closure of a cardiac opening in a patient.
- the method includes inserting a closure device as described above into a heart of the patient, positioning the closure device within the cardiac opening with the balloon of the closure device deflated, and inflating the balloon to expose the adhesive coated on the outer surface of the balloon to the cardiac opening.
- the balloon of the closure device is removed from the patient after the adhesive is exposed to the cardiac opening.
- the invention provides a closure device that includes a balloon having an outer surface, a porous band encircling only a portion of the outer surface of the balloon, and an adhesive disposed between the outer surface of the balloon and the porous band.
- the porous band has a plurality of openings.
- the porous band encircles a center portion of the balloon, which may be, for example, tubularly-shaped.
- a substance for stimulating tissue growth is disposed between the outer surface of the balloon and the porous band.
- the invention in still another aspect, relates to a method that includes inserting a closure device as just described into a heart of the patient, positioning the closure device within the cardiac opening, and applying a pressure to the balloon of the closure device to expose the adhesive through the plurality of openings of the porous band to the cardiac opening.
- the balloon and the porous band of the closure device are removed from the patient after the adhesive is exposed through the plurality of openings of the porous band to the cardiac opening.
- the closure device includes an outer balloon that has a plurality of first holes, an inner balloon that has a plurality of second holes, and an adhesive.
- the adhesive is contained within the inner balloon, which is itself contained within the outer balloon.
- At least one of the plurality of first holes and the plurality of second holes includes pores.
- at least one of the plurality of first holes and the plurality of second holes includes slits.
- at least one of the inner balloon and the outer balloon is tubularly-shaped.
- a substance for stimulating tissue growth is contained within the inner balloon.
- the invention in a further aspect, relates to a method that includes inserting a closure device as just described into a heart of the patient, positioning the closure device within the cardiac opening, applying a first pressure to the inner balloon to express the adhesive through the plurality of second holes, and applying a second pressure to the outer balloon to express the adhesive through the plurality of first holes to the cardiac opening.
- the outer balloon and the inner balloon of the closure device are removed from the patient after the adhesive is expressed through the plurality of first holes to the cardiac opening.
- the closure device includes a balloon and an adhesive.
- the balloon has a membrane constructed from a wicking material and the adhesive is contained within the membrane of the balloon.
- the balloon is tubularly-shaped.
- a substance for stimulating tissue growth is contained within the membrane of the balloon. At least a portion of the adhesive and/or the substance for stimulating tissue growth may be absorbed within the membrane of the balloon.
- the invention in yet another aspect, relates to a method that includes inserting a closure device as just described into a heart of the patient, positioning the closure device within the cardiac opening, and contacting a tissue surface of the cardiac opening with the membrane of the balloon to apply the adhesive to the tissue surface of the cardiac opening.
- the balloon of the closure device is removed from the patient after the adhesive is applied to the tissue surface of the cardiac opening.
- the adhesives are cyanoacrylates, fibrin based adhesives, albumin gluteraldehyde type adhesives, or light activated adhesives.
- the substances for stimulating tissue growth may be, for example, growth factors, pharmacological agents for stimulating tissue growth, irritants for encouraging an inflammatory response, cells, or genes.
- the cardiac opening is, for example, a patent foramen ovale or a left atrial appendage.
- the invention in still another aspect, relates to a method for percutaneous transluminal closure of a left atrial appendage in a patient.
- the method includes inserting a closure device into a heart of the patient and positioning the closure device within the left atrial appendage.
- the closure device includes a balloon having a plurality of holes and an adhesive contained within the balloon.
- the method further includes applying a pressure to the balloon to separate the plurality of holes and to expose the adhesive to the left atrial appendage.
- the method also includes coupling the balloon of the closure device to the left atrial appendage with the exposed adhesive.
- the invention provides a closure device that includes a balloon with an outer surface, a first adhesive coated on the outer surface of the balloon, and a light source located within the balloon.
- the closure device further includes a second adhesive coated on an inner surface of the balloon. At least one of the first adhesive and the second adhesive may be a light activated adhesive.
- the closure device further includes a divider having first and second surfaces. The first surface of the divider may be coupled to the first adhesive and the second surface of the divider may be coated with a primer.
- the balloon may be made of an elastomer, or, alternatively, a biological material, which may be, for example, a collagen or a bioresorbable polymer.
- the balloon may be tubularly-shaped.
- the invention in a further aspect, relates to a method that includes inserting a closure device as just described into a heart of the patient, positioning the closure device within the cardiac opening, and coupling the closure device to the cardiac opening to substantially occlude the cardiac opening.
- coupling the closure device to the cardiac opening includes inflating the balloon, emitting light from the light source located within the balloon, and activating the adhesive coated on the outer surface of the inflated balloon with the emitted light.
- the inflated balloon may then be deflated and left behind in the cardiac opening.
- Coupling the closure device to the cardiac opening may also include applying a primer to a tissue surface of the cardiac opening.
- the cardiac opening may be, for example, a patent foramen ovale or a left atrial appendage.
- the invention provides a percutaneous transluminal system for positioning a closure device in a cardiac opening.
- the system includes a catheter, a closure device coupled to the catheter, and a first locator coupled to at least one of the catheter and the closure device.
- the first locator is for positioning the closure device within the cardiac opening.
- the first locator is a disk, a plurality of arms, a rod, or a balloon.
- the first locator may be, for example, a right atrial locator or a left atrial locator.
- an adhesive such as, for example, a cyanoacrylate, a fibrin based adhesive, or an albumin gluteraldehyde type adhesive, is coated on the first locator.
- the system further includes a second locator coupled to at least one of the catheter and the closure device. The second locator is also for positioning the closure device within the cardiac opening.
- the system further includes an adhesive coupled to the closure device.
- the adhesive may be, for example, a cyanoacrylate, a fibrin based adhesive, or an albumin gluteraldehyde type adhesive.
- the adhesive coupled to the closure device may alternatively be a light activated adhesive and the system may further include a light source coupled to the catheter for activating the light activated adhesive.
- the closure device is a balloon, which may be, for example, tubularly-shaped, hi one embodiment, the balloon includes a first end, a second end, and a lumen extending from the first end to the second end. hi another embodiment, the balloon includes a first opening at the first end of the balloon and a second opening at the second end of the balloon. In yet another embodiment, the balloon comprises a plurality of holes. An adhesive may be coated on an outer surface of the balloon, coated on an inner surface of the balloon, or simply contained within the lumen of the balloon.
- the invention in still another aspect, relates to a method for delivering a closure device to a cardiac opening in a patient.
- the method includes inserting, into a heart of the patient, a system for positioning the closure device within the cardiac opening.
- the system is as just described.
- the first locator of the system is used to locate the cardiac opening and also to position the closure device within the cardiac opening,
- the method further includes coupling the closure device to the cardiac opening to substantially occlude the cardiac opening.
- the method may also include coupling the first locator to a tissue surface of the patient that is proximate the cardiac Opening.
- the cardiac opening may be, for example, a patent foramen ovale or a left atrial appendage.
- the invention provides a percutaneous transluminal system for closing a cardiac opening.
- the system includes a first catheter having a proximal end, a distal end, and a lumen extending from the proximal end to the distal end, a second catheter at least partially enclosed within the lumen of the first catheter, and a lining coupled to the first and second catheters.
- the second catheter is movable between a retracted state and a deployed state. In the retracted state of the second catheter, the lining is positioned within the lumen of the first catheter. In the deployed state of the second catheter, the lining inverts and is positioned outside the lumen of the first catheter.
- the lining is sock-shaped.
- adhesives and/or substances for stimulating tissue growth may be coated on a surface of the lining and/or contained within the lining itself.
- the invention in a further aspect, relates to a method for percutaneous transluminal closure of a cardiac opening in a patient.
- the method includes inserting a system as just described into a heart of the patient, positioning the system proximate the cardiac opening with the second catheter in a retracted state, and deploying the second catheter to invert the lining and position the lining within the cardiac opening.
- the system further includes an adhesive coated on a surface of the lining and the adhesive is exposed to the cardiac opening when the second catheter is deployed.
- the lining includes a plurality of holes and the system further includes an adhesive contained within the lining.
- the adhesive is exposed through the plurality of holes to the cardiac opening when the second catheter is deployed.
- the system is removed from the patient after the adhesive is exposed to the cardiac opening, which may be, for example, a patent foramen ovale.
- FIG. 1 is a cutaway view of a heart illustrating a patent foramen ovale.
- FIG. 2 is a partial cross-sectional view of another heart illustrating a left atrial appendage.
- FIG. 3 is a schematic perspective view of a system, including a delivery catheter and a closure device, for the percutaneous transluminal closure of a cardiac opening according to an illustrative embodiment of the invention.
- FIGS. 4A-4B illustrate extended and folded configurations of a frame for the closure device illustrated in FIG. 3 , according to an illustrative embodiment of the invention.
- FIG. 5 is a schematic perspective view of a system, including a delivery catheter and a closure device, for the percutaneous transluminal closure of a cardiac opening according to another illustrative embodiment of the invention.
- FIG. 6 is a schematic cross-sectional view of a system, including a delivery catheter and a closure device, for the percutaneous transluminal closure of a cardiac opening according to another illustrative embodiment of the invention.
- FIG. 7 is a schematic side view of a closure device for the percutaneous transluminal closure of a cardiac opening according to another illustrative embodiment of the invention.
- FIG. 8 is a schematic side view of a closure device, according to another illustrative embodiment of the invention, coupled to the septum secundum and the septum primum of a patent foramen ovale.
- FIG. 9 is a schematic side view of a closure device, according to another illustrative embodiment of the invention, coupled to the septum secundum and the septum primum of a patent foramen ovale.
- FIG. 10 is a schematic side view of a closure device, according to another illustrative embodiment of the invention, coupled to the septum secundum and the septum primum of a patent foramen ovale.
- FIGS. 11A-11C illustrate the stages, according to an illustrative embodiment of the invention, for closing a patent foramen ovale in a patient.
- FIG. 11D illustrates a left atrial appendage closed according to an illustrative embodiment of the invention.
- FIG. 11E-11F illustrates the stages, according to another illustrative embodiment of the invention, for closing a patent foramen ovale in a patient.
- FIG. 12 is a schematic side view of the illustrative closure device of FIG. 7 coupled to the septum secundum of a patent foramen ovale.
- FIG. 13 illustrates a compound for the percutaneous transluminal closure of a cardiac opening according to an illustrative embodiment of the invention.
- FIG. 14 is a schematic side view of a closure system according to an illustrative embodiment of the invention.
- FIG. 15 is a schematic perspective view of a closure system according to another illustrative embodiment of the invention.
- FIG. 16 is a schematic side view of a closure system according to another illustrative embodiment of the invention.
- FIG. 17 is a schematic side view of a closure system according to another illustrative embodiment of the invention.
- FIG. 18 is a schematic perspective view of an inflated balloon according to an illustrative embodiment of the invention.
- FIG. 19 is a schematic perspective view of the illustrative balloon of FIG. 17 deflated according to an illustrative embodiment of the invention.
- FIG. 20 is a schematic cross-sectional view of the illustrative balloon of FIG. 19 taken along the line 19 - 19 .
- FIG. 21 is a schematic cross-sectional view of the illustrative balloon of FIG. 20 inflated according to an illustrative embodiment of the invention.
- FIG. 22 is a schematic perspective view of a deflated balloon according to another illustrative embodiment of the invention.
- FIG. 23 is a schematic perspective view of a balloon according to another illustrative embodiment of the invention.
- FIG. 24 is a schematic cross-sectional view of the illustrative balloon of FIG. 23 taken along the line 23 - 23 .
- FIG. 25 is a schematic cross-sectional view of a balloon according to another illustrative embodiment of the invention.
- FIG. 26 is a schematic cross-sectional view of concentric balloons according to another illustrative embodiment of the invention.
- FIG. 27 is a schematic cross-sectional view of a balloon according to another illustrative embodiment of the invention.
- FIG. 28 is a schematic cross-sectional view of a balloon according to another illustrative embodiment of the invention.
- FIG. 29 is a schematic cross-sectional view of the illustrative balloon of FIG. 28 taken along the line 28 - 28 .
- FIG. 30 is a schematic side view of a closure system, including a retracted sock catheter, according to another illustrative embodiment of the invention.
- FIG. 31 is a schematic side view of the illustrative closure system of FIG. 30 , including a deployed sock catheter.
- FIGS. 32A-32D illustrate the stages, according to an illustrative embodiment of the invention, for closing a patent foramen ovale in a patient.
- FIGS. 33A-33E illustrate the stages, according to another illustrative embodiment of the invention, for closing a patent foramen ovale in a patient.
- FIGS. 34A-34B illustrate the stages, according to another illustrative embodiment of the invention, for closing a patent foramen ovale in a patient.
- the present invention features devices, systems, and related methods for closing cardiac openings, such as, for example, the patent foramen ovale described below, arid for obliterating cardiac cul-de-sacs, such as, for example, the left atrial appendage described below.
- FIG. 1 depicts a cutaway view of a heart 20 .
- the heart 20 includes a septum 24 that divides a right atrium 26 from a left atrium 32 .
- the septum 24 includes a septum secundum 36 and a septum primum 40 .
- An exemplary cardiac opening, a patent foramen ovale 44 that is to be corrected by the devices, systems, and related methods of the present invention is located between the septum secundum 36 and the septum primum 40 .
- the patent foramen ovale 44 provides an undesirable fluid communication between the right atrium 26 and the left atrium 32 and, under certain conditions, allows for the shunting of blood between the right atrium 26 and the left atrium 32 . If the patent foramen ovale 44 is not closed or obstructed in some manner, a patient is placed at a higher risk for an embolic stroke in addition to other circulatory abnormalities.
- FIG. 2 depicts a partial cross-sectional view of another heart 60 .
- the heart 60 includes an aorta 64 , a left ventricle 68 , a left atrium 72 , and a fossa ovalis 76 .
- the heart 60 also includes an exemplary cardiac cul-de-sac, a left atrial appendage 80 , that is to be obliterated by the devices, systems, and related methods of the present invention. Under certain conditions, blood clots may form in the left atrial appendage 80 .
- the left atrial appendage 80 is not closed or obstructed in some manner, a patient is placed at a higher risk of having the blood clots pass from the heart 60 and into the vasculature of the brain, causing a stroke or a transient ischemic attack.
- embodiments of the devices of the invention typically include a patch or a balloon.
- an adhesive maybe coated on the patch and the adhesive may require activation (e.g., light activation) to bond the patch to a patient's tissue surface.
- the patch is placed across the cardiac opening and the adhesive activated to bond the patch to the patient's tissue. The cardiac opening is thereby substantially occluded.
- a removable frame is enclosed within the patch.
- the patch is placed across the cardiac opening and thermally welded to the patient's tissue. The frame is then removed from the patch.
- the patch is a U-shaped patch that is bonded to a septum secundum of a patent foramen ovale.
- the U-shaped patch includes, for example, a barrier that is attached to a septum primum to substantially occlude the patent foramen ovale.
- the U-shaped patch includes, for example, a substance that stimulates tissue growth from the septum secundum and/or the septum primum. In such a case, the patent foramen ovale is encouraged to heal itself.
- Compounds of the invention may be employed on their own, or in conjunction with the devices of the invention, to occlude the cardiac openings described herein. Typically, the compounds are first physically injected or otherwise applied into the cardiac openings and thereafter expand to substantially occlude the cardiac openings.
- FIG. 3 depicts a system 100 , capable of being used for the percutaneous transluminal closure of a cardiac opening, according to an illustrative embodiment of the invention.
- the system 100 includes a closure device 104 and a delivery catheter 108 that is used to deliver the closure device 104 to the cardiac opening in a patient's heart.
- the delivery catheter 108 includes a proximal end 112 (i.e., an end that is closest to a physician when the physician is using the system 100 ), an opposite, distal end 116 , and a lumen 120 that extends from the proximal end 112 to the distal end 116 .
- the closure device 104 includes a patch 124 and at least one hollow channel 136 enclosed within the patch 124 .
- the patch 124 includes a plurality of hollow channels 136 extending from a common center similar to spokes of a wheel.
- the closure device 104 is coupled to the distal end 116 of the delivery catheter 108 such that the lumen 120 of the delivery catheter 108 is contiguous with the hollow channels 136 enclosed within patch 124 .
- the closure device 104 is releasably coupled to the distal end 116 of the delivery catheter 108 .
- the closure device 104 is coupled to the distal end 116 of the delivery catheter 108 so that it may be separated from the delivery catheter 108 through the application of a force, such as a torsional force applied by the physician to the proximal end 112 of the delivery catheter 108 and transmitted along the delivery catheter 108 to the point of coupling with the closure device 104 .
- a force such as a torsional force applied by the physician to the proximal end 112 of the delivery catheter 108 and transmitted along the delivery catheter 108 to the point of coupling with the closure device 104 .
- the lumen 120 of the catheter 108 and the hollow channels 136 may be used, for example, as conduits to channel light through the delivery catheter 108 and the patch 124 .
- a physician using the system 100 positions a light source (not shown) proximal to the proximal end 112 of the delivery catheter 108 , or at some other point within the lumen 120 of the delivery catheter 108 , and projects light down the lumen 120 and through the hollow channels 136 of the patch 124 .
- the lumen 120 and the hollow channels 136 enclose one or more fiber optic cables for delivering light through the delivery catheter 108 and the patch 124 . In such a case, the fiber optic cables are connected at their proximal ends to a source of illumination. The light serves to activate adhesive 128 to bond the patch 124 to a patient's tissue.
- the lumen 120 and the hollow channels 136 enclose a continuous frame 110 .
- the frame 110 may be constructed from a shape memory alloy, such as, for example, from nitinol or, alternatively from a polymer, stainless steel, or any combination of the above materials.
- the frame 110 is used as a means for expanding the patch 124 of the closure device 104 and as a means for holding the patch 124 flush against a patient's tissue surface proximate the cardiac opening.
- the frame 110 may include a plurality of arms having springs or resilient coils 113 that cause the closure device 104 to expand. Referring to FIG.
- a physician advances a sheath 400 into a patient's heart and positions the distal end 404 of the sheath proximate the cardiac opening. This is described below with reference to FIGS. 11A and 11B .
- the arms 111 of frame 110 may bend at the springs or resilient coils 113 to facilitate passage of the closure device through the sheath 400 .
- the frame 110 may also be coupled at its proximal end to a power supply and used to deliver radio frequency energy to a tissue surface proximate the cardiac opening.
- the fiber optic cables and/or the frame 110 may be removable from the patch 124 after the patch 124 is coupled to a patient's tissues proximate the cardiac opening.
- the fiber optic cables and/or the frame 110 may be retracted from the hollow channels 136 of the patch 124 into the contiguous lumen 120 of the delivery catheter 108 .
- an adhesive 128 is applied to the patch 124 as a coaling.
- the adhesive 128 is coated on a distal side 132 of the patch 124 , or, alternatively, on a proximal side 130 of the patch 124 (not shown).
- the adhesive 128 may be, for example, a light activated adhesive, such as an adhesive curable with ultraviolet light.
- light may be delivered through the delivery catheter 108 and the patch 124 to the adhesive 128 and used to activate the adhesive 128 .
- the adhesive 128 may be a heat activated adhesive, a chemically activated adhesive, or a bioreactive adhesive.
- the lumen 120 and hollow channels 136 are used to deliver heat, chemicals, or biological agents, respectively, to the adhesive 128 .
- the lumen 120 and hollow channels 136 may enclose a pipe to bidirectionally carry hot- water proximate a heat activated adhesive 128 .
- radio frequency energy (delivered, for example, by the frame 110 enclosed within the lumen 120 and the hollow channels 136 ), electrical resistance, ultrasound energy, laser energy, or chemical energy may be supplied to the heat activated adhesive 128 .
- the adhesive 128 is introduced to the distal side 132 or to the proximal side 130 of the patch 124 via the lumen 120 and the hollow channels 136 .
- holes 137 which pass from the hollow channels 136 to the surface of the patch 124 , are present on the distal side 132 or on the proximal side 130 of the patch 124 in the region of the hollow channels 136 .
- the physician When the physician is ready to adhere the patch 124 to the patient's tissues proximate the intracardiac defect, the physician injects the adhesive 128 through the lumen 120 , through the hollow channels 136 , and through the holes 137 to the surface of the distal side 132 or the surface of the proximal side 130 of the patch 124 .
- the patch 124 may be made, either entirely or in part, from a biological material, a bioresorbable material (e.g., polylactide, glycolide, or caprolactone), a synthetic material (e.g., polyester, expanded polytetrafluoroethylene (ePTFE), or polyvinyl alcohol), a polymeric material, a shape memory material (e.g., a shape memory alloy), a metal mesh, or other suitable material for closing a cardiac opening, such as combinations of these materials.
- a bioresorbable material e.g., polylactide, glycolide, or caprolactone
- a synthetic material e.g., polyester, expanded polytetrafluoroethylene (ePTFE), or polyvinyl alcohol
- a polymeric material e.g., a shape memory material (e.g., a shape memory alloy), a metal mesh, or other suitable material for closing a cardiac opening, such as combinations of these materials.
- the closure device 104 is devoid of the adhesive 128 .
- radio frequency energy is delivered via the frame 110 and the patch 124 is thermally welded to a patient's tissue surface proximate the cardiac opening.
- the patch 124 is typically made from a biological material.
- the patch 124 is made from a collagen based material derived from the intestine, stomach, skin, bladder, or pericardium of a porcine animal, a bovine animal, and/or a human.
- the patch 124 may be disk-shaped and have a circular cross-section.
- the patch 124 may have a variety of other cross-sectional shapes suitable for closing a cardiac opening, including, but not limited to, rectangular and triangular.
- the patch 124 may also include one or more radio-opaque markers or radio-opaque fillers to indicate its position within a patient's body.
- FIG. 5 depicts a system 100 , capable of being used for the percutaneous transluminal closure of a cardiac opening, according to another illustrative embodiment of the invention.
- the closure device 104 of the system 100 further includes a removable divider 144 , such as, for example, a non-reactive sheet 144 , having a first surface 148 and a second surface 152 .
- non-reactive means that the divider does not appreciably adhere to adhesive 128 , nor interact with material, such as a primer, that may be coated onto a surface of divider 144 .
- the first surface 148 of the removable divider 144 contacts the adhesive 128 of the closure device 104 .
- a primer 156 Coated on the second surface 152 of the removable divider 144 is a primer 156 .
- the primer 156 prepares the tissue surface of the patient to which the closure device 104 will be adhered during the process of closing the patient's cardiac opening.
- the primer 156 helps to activate the adhesive 128 and/or bond the adhesive 128 to the patient's tissue surface.
- the removable divider 144 may be removed from the rest of the closure device 104 .
- sutures 145 illustrated in FIG. 5 , are attached to the removable divider 144 at a point 146 on the edge of the removable divider 144 . The physician may remove the removable divider 144 from the rest of the closure device 104 by applying traction to the proximal end 147 of the suture, and withdrawing the removable divider 144 through a perforation 149 in the delivery catheter 108 .
- the adhesive 128 is coated on a distal side 132 of the patch 124 .
- the removable divider 144 and the primer 156 are therefore also located distal to the patch 124 .
- the adhesive 128 is coated oil a proximal side 130 of the patch 124 (not shown). In such an embodiment, the removable divider 144 and the primer 156 are located proximal to the patch 124 .
- FIG. 6 depicts a system 200 , capable of being used for the percutaneous transluminal closure of a cardiac opening, according to another illustrative embodiment of the invention.
- the system 200 includes a closure device 204 and a delivery catheter 208 that is used to deliver the closure device 204 to the cardiac opening in a patient's heart.
- the delivery catheter 208 includes a proximal end 212 (i.e., an end that is closest to a physician when the physician is using the system 200 ) and an opposite, distal end 216 .
- the closure device 204 includes a housing 222 , a releasable patch 224 coupled to a distal surface 226 of the housing 222 , and an adhesive 228 coated on a distal side 232 of the releasable patch 224 .
- the housing 222 is conically shaped, with the distal surface 226 of the housing 222 forming the base of the cone and the apex 218 of the cone being coupled to the distal end 216 of the delivery catheter 208 .
- the housing 222 may be otherwise shaped, for example as a tetrahedron with the distal surface 226 of the housing 222 forming the triangular base of the tetrahedron and the apex 218 of the tetrahedron being coupled to the distal end 216 of the delivery catheter 208 .
- a light source 236 Enclosed within the housing 222 is, in one embodiment, a light source 236 .
- the light source 236 may be, for example, a light bulb or a fiber optic cable that is used to deliver light to, for example, a light activated adhesive 228 located at the distal surface 226 of the housing 222 .
- the releasable patch 224 of the closure device 204 may be made, either entirely or in part, from biological materials, bioresorbable materials, synthetic materials, polymeric materials, shape memory materials, and/or metal meshes. Moreover, portions of the releasable patch 224 may be made from a translucent material and may include one or more radio-opaque markers or radio-opaque fillers to indicate the anatomical position of the releasable patch 224 within a patient's body.
- the releasable patch 224 of the closure device 204 may be disk-shaped and have a circular cross-section to match the shape of the distal surface 226 of the housing 222 .
- the releasable patch 224 may have a variety of other cross- sectional shapes suitable for closing a cardiac opening
- the housing 222 is shaped as a triangular prism
- the releasable patch 224 may have a triangular or rectangular cross-section to match the shape of the distal surface 226 of the housing 222 .
- the adhesive 228 coated to the distal side 232 of the releasable patch 224 , is a light activated adhesive.
- the adhesive 228 is an adhesive curable with ultraviolet light.
- the adhesive 228 may be a heat activated adhesive, a chemically activated adhesive, or a bioreactive adhesive.
- the light source 236 is replaced by other devices.
- a pipe may be used to bidirectionally carry hot water proximate the heat activated adhesive 228 .
- electrical resistance, radio frequency energy, ultrasound energy, laser energy, or chemical energy is delivered to a heat activated adhesive 228 .
- chemicals are delivered to a chemically activated adhesive 228 or biological agents are delivered to a bioreactive adhesive 228 .
- the closure device 204 may similarly further include a removable divider 244 having a primer 256 coated on its second surface 252 . As illustrated in FIG. 6 , the removable divider 244 separates the adhesive 228 from the primer 256 .
- FIG. 7 depicts a closure device 304 , capable of being used for the percutaneous transluminal closure of a patent foramen ovale, according to another illustrative embodiment of the invention.
- the exemplary closure device 304 includes a U-shaped patch 324 and an adhesive 328 .
- the U-shaped patch 324 includes an outer surface 306 and an inner surface 310 to which the adhesive 328 is coated.
- the U-shaped patch is specifically configured for attachment to a septum secundum 36 of a patent foramen ovale.
- the U-shaped patch 324 may be made from the biological materials, the bioresorbable materials, the synthetic materials, the polymeric materials, the shape memory materials, and/or the metal meshes described above, or from other suitable materials for closing a patent foramen ovale, such as combinations of these materials.
- the adhesive 328 may be, for example, a cyanoacrylate, a fibrin based adhesive, and/or a light activated adhesive.
- the U-shaped patch 324 further includes on its outer surface 306 , i.e., convex surface, and/or on its inner surface 310 , i.e., concave surface, a substance that stimulates in-growth of the patient's tissue into the patent foramen ovale following placement of the closure device 304 on the septum secundum 36 of the patent foramen ovale.
- the growth substance is, for example, a growth factor, such as a vascular endothelial growth factor, a basic fibro growth factor, or an angiogenic growth factor.
- the growth substance is a pharmacological agent for stimulating tissue growth, such as, for example, growth of cells or expression of genes.
- the growth substance is a topical irritant for encouraging an inflammatory response, such as, for example, cotton seed oil or alcohol.
- the closure device 304 is placed on the septum secundum 36 , the growth substance is delivered to, or impregnated within, the septum secundum 36 and the tissue in-growth into the patent foramen ovale therefore occurs from the septum secundum 36 .
- the natural hydraulic pressure difference between the right atrium 26 and the left atrium 32 eventually causes the septum primum 40 to contact the closure device 304 that has been coupled to the septum secundum 36 .
- the growth substance coated on the outer surface 306 of the closure device 304 would contact the septum primum 40 and be delivered to, or impregnated within, the septum primum 40 . Tissue in-growth into the patent foramen ovale would therefore occur from the septum primum 40 .
- the newly grown tissue leads to the closure of the patent foramen ovale.
- a substance for increasing endothelization or, alternatively, a substance for decreasing thrombogenicity, such as, for example, heparin, is coated on the outer surface 306 and/or on the inner surface 310 of the U-shaped patch 324 .
- FIGS. 8 , 9 , and 10 depict, according to further illustrative embodiments of the invention, the exemplary closure device 304 of FIG. 7 coupled to the septum secundum 36 of a patent foramen ovale.
- the closure device 304 may further include at least one barrier 314 coupled to the U-shaped patch 324 .
- the closure device 304 may include a right atrial barrier 314 A, as shown in FIG. 8 , for blocking an opening to the patent foramen ovale from the right atrium 26 , a left atrial barrier 314 B, as shown in FIG.
- the right atrial barrier 314 A and/or the left atrial barrier 314 B include(s) an adhesive for bonding the barrier 314 to the septum primum 40 , as shown.
- the right atrial barrier 314 A and/or the left atrial barrier 314 B include(s), as described above for the U-shaped patch 324 , a substance that stimulates tissue in-growth into the closure device 304 following placement of the closure device 304 on the septum secundum 36 of the patent foramen ovale.
- the invention provides methods for percutaneously closing a cardiac opening in a patient.
- FIGS. 11A-11C depict the steps of an illustrative method for closing a cardiac opening in a patient using the closure device 104 of the invention. Similar steps, with appropriate differences described below, are also performed in closing a cardiac opening in a patient using the closure device 204 of the invention.
- the cardiac opening illustrated in FIGS. 11A-11C is a patent foramen ovale. However, as described below, the methods of the invention may also be used to close or obliterate a left atrial appendage.
- an operator such as a physician advances a sheath 400 into the patient's heart and positions a distal end 404 of the sheath 400 proximate the cardiac opening.
- the physician advances the system. 100 , including the closure device 104 and the delivery catheter 108 , into and through a lumen 408 of the sheath 400 .
- the physician continues to advance the system 100 though the lumen 408 of the sheath 400 until the closure device 104 exits the distal end 404 of the sheath 400 and expands to a position proximate the cardiac opening, as illustrated in FIG. 11B .
- the closure device 104 may be made to expand by any of a variety of means.
- the shape memory frame 110 described above may cause the closure device 104 to expand.
- the patch 124 of the closure 104 may itself be made from a shape memory material, such as a shape memory alloy.
- the physician in order to couple the closure device 104 to a tissue surface of the patient proximate the cardiac opening, the physician first applies the primer 156 to the tissue surface. In one embodiment, the physician advances the closure device 104 distally to contact the patient's tissue surface with the primer 156 contained on the second surface 152 of the removable divider 144 . The physician then withdraws the closure device 104 proximally to separate it from the patient's tissues and removes the removable divider 144 from about the rest of the closure device 104 .
- the physician advances the closure device 104 to contact the patient's tissue proximate the cardiac opening with the distal side 132 of the patch 124 .
- the adhesive 128 is coated on the surface of the distal side 132 of patch 124 and is therefore immediately applied to the patient's tissues.
- the physician injects the adhesive 128 through the lumen 120 , through the hollow channels 136 , and through holes 137 on the distal side 132 of the patch 124 to apply the adhesive 128 to the patient's tissue.
- the physician activates the adhesive 128 to cure the adhesive 128 to the patient's tissues.
- the physician provides light to the hollow channels 136 enclosed within the patch 124 , thereby activating the adhesive 128 .
- the physician uses the closure device 204 to close the cardiac opening (see FIG. 6 )
- the physician causes the light source 236 enclosed within the housing 222 of the closure device 204 to emit light.
- the housing 222 prevents the blood in the area surrounding the closure device 204 from blocking, or otherwise interfering with, the passage of emitted light. The housing 222 therefore ensures that the emitted light reaches the adhesive 228 to activate the adhesive 228 .
- the physician separates the patch 124 of the closure device 104 from the delivery catheter 108 of the system 100 , or, alternatively, separates the releasable patch 224 of the closure device 204 from the housing 222 of the closure device 204 .
- the physician causes the patch 124 or the releasable patch 224 to break away from the delivery catheter 108 or the housing 222 , respectively, by applying a torque.
- a variety of other mechanical means may be used to separate the patch 124 from the delivery catheter 108 or the releasable patch 224 from the housing 222 .
- the patch 124 of the closure device 104 is positioned across the cardiac opening to substantially occlude the cardiac opening
- the patch 124 is positioned across a patent foramen ovale.
- steps similar to those described above are performed to position the patch across a left atrial appendage 80 , as illustrated in FIG. 11D .
- the hollow channels 136 of the patch 124 of the closure device 104 enclose the frame 110 , but the closure device 104 does not also include the adhesive 128 or the removable divider 144 containing the primer 156 .
- the physician following the exit, and the expansion, of the closure device 104 from the distal end 404 of the sheath 400 , as illustrated in FIG. 11B , the physician contacts the patient's tissues proximate the cardiac opening with the patch 124 of the closure device 104 and thermally welds the patch 124 to the patient's tissues. More specifically, in one embodiment, the physician generates a radio frequency current through the frame 110 enclosed within the hollow channels 136 of the patch 124 .
- the physician fuses the patch 124 to the patient's tissues.
- the patch 124 of the closure device 104 is positioned across the cardiac opening to substantially occlude the cardiac opening.
- the physician then retracts the frame 110 from within the patch 124 and removes the frame 110 , along with the sheath 400 and the delivery catheter 108 , from the patient's body.
- the closure device 104 may be deployed in the right atrium 26 , as illustrated in FIG. 11B , and the patch 124 may be bonded to the right atrial walls of the septum primum 40 and the septum secundum 36 , as illustrated in FIG. 11C .
- the sheath 400 is advanced through the patent foramen ovale and the closure device 104 is deployed in the left atrium 32 , as illustrated in FIG. 11E .
- the patch 124 may be bonded thereto, as illustrated in FIG. 11F , in any of the manners described above.
- the physician places the patch 124 within the cardiac opening or the left atrial appendage, and bonds it thereto.
- the physician To percutaneously close a patent foramen ovale using the closure device 304 of the invention, the physician first performs essentially the same steps as illustrated and described above with respect to FIGS. 11A and 11B . More specifically, in one embodiment, the physician positions the distal end 404 of the sheath 400 proximate the patent foramen ovale and advances the closure device 304 , by means of a delivery catheter attached to the closure device 304 , into and through the lumen 408 of the sheath 400 until the closure device 304 exits the distal end 404 of the sheath 400 and expands to a position proximate the patent foramen ovale.
- the physician couples the inner surface 310 of the closure device 304 , which contains the adhesive 328 , to the septum secundum 36 .
- the physician removes the delivery catheter from about the U-shaped patch 324 of the closure device 304 , leaving the closure device 304 attached to the patient's septum secundum 36 , as illustrated in FIG. 12 .
- the U-shaped patch 324 may include a substance that stimulates in-growth of the patient's tissue into the closure device 304 from either the septum secundum 36 , the septum primum 40 , or both the septum secundum 36 and the septum primum 40 Following placement of the closure device 304 on the septum secundum 36 , as illustrated in FIG. 12 , this tissue in-growth may be relied upon to substantially occlude the patent foramen ovale. Alternatively, as illustrated in FIGS.
- the closure device 304 may be further provided with either a right atrial bather 314 A, a left atrial barrier 314 B, or both the right atrial barrier 314 A and the left atrial barrier 314 B to assist in closing the patent foramen ovale.
- the barriers 314 A, 314 B may include adhesives and may be bonded to the septum primum 40 , as shown.
- the barriers 314 A, 314 B may include substances that stimulate tissue in-growth into the closure device 304 from either the septum secundum 36 , the septum primum 40 , or both the septum secundum 36 and the septum primum 40 .
- the invention provides a compound for percutaneous transluminal closure of a cardiac opening, such as a patent foramen ovale, or for percutaneous transluminal obliteration of a cardiac cul-de-sac, such as a left atrial appendage.
- the compound is used alone to close the cardiac opening or to obliterate the cardiac cul-de-sac.
- the compound is used together with a closure device 104 , 204 , or 304 .
- FIG. 13 depicts an exemplary compound 500 in accordance with this aspect of the invention.
- the compound 500 includes an adhesive 504 and a plurality of composite particles 508 disposed within the adhesive 504 .
- the plurality of composite particles 508 are capable of expansion upon contact with blood and/or water.
- the composite particles 508 are, for example, gelatin particles, biological particles, bioresorbable particles, and/or foam particles that swell upon contact with blood and/or water.
- the adhesive 504 is a fibrin based adhesive.
- the compound 500 includes other types of adhesives 504 .
- the adhesive 504 may be a permanent adhesive in the sense that, following placement of the adhesive 504 into the cardiac opening, the adhesive 504 permanently remains in the cardiac opening over time.
- the adhesive 504 is a temporary adhesive that gradually disappears over time after having been placed in the cardiac opening.
- Mixed into the adhesive 504 may be a substance that promotes tissue in-growth into the cardiac opening over time.
- a physician positions the distal end of the sheath proximate the cardiac opening.
- the physician advances, for example, a delivery catheter containing the compound 500 through a lumen of the sheath, until the delivery catheter exits the distal end of the sheath to he within the cardiac opening.
- the physician then injects the compound 500 into the cardiac opening.
- the plurality of composite particles 508 disposed within the adhesive 504 of the compound 500 expand. By expanding, the plurality of composite particles 508 help to lock the adhesive 504 into place and to prevent the adhesive 504 from being washed away by the surrounding blood.
- the adhesive 504 of the compound 500 cures both to the patient's surrounding tissue and to the plurality of expanding composite particles 508 .
- the compound 500 substantially occludes the cardiac opening such as a patent foramen ovale. Similar steps may be performed to substantially obliterate an intra-cardiac cul-de-sac, such as the left atrial appendage.
- the compound 500 may also be used in conjunction with the closure devices 104 , 204 , and 304 described above.
- the patch 124 of the closure device 104 or the releasable patch 224 of the closure device 204 may be positioned across the cardiac opening, for example the patent foramen ovale or across the intra-cardiac cul-de-sac such as the left atrial appendage and coupled to the proximate tissue surface.
- the closure device 304 including either or both the right atrial barrier 314 A and the left atrial barrier 314 B, described above, maybe bonded to the septum secundum 36 , as described above.
- the above-described patch 124 of the closure device 104 , the releasable patch 224 of the closure device 204 , and/or the atrial barriers 314 A, 314 B of the closure device 304 can thus be used to ensure that the adhesive 504 of the compound 500 remains in the cardiac opening and can also be used to aid the compound 500 in occluding the cardiac opening or the cardiac cul-de-sac, or in obliterating the cardiac cul-de-sac.
- FIG. 14 depicts an exemplary percutaneous transluminal system 600 for positioning a balloon 700 in, for example, the patent foramen ovale 44 or the left atrial appendage 80 described above.
- the closure system 600 includes the balloon 700 coupled to a balloon catheter 612 .
- either an adhesive, a substance for stimulating tissue growth, or both an adhesive and a substance for stimulating tissue growth is coated on, or contained within, the balloon 700 .
- the balloon 700 may be placed within a cardiac opening, such as a patent foramen ovale of the patient. Once placed within the cardiac opening, the balloon 700 may be manipulated to deliver the adhesive and/or the substance for stimulating tissue growth to the tissue surface of the cardiac opening.
- the balloon 700 is then released from the balloon catheter 612 and left behind in the cardiac opening, while the balloon catheter 612 is removed from the patient. In such a case, the balloon 700 assists in closing the cardiac opening. Similar steps may be performed to close a cardiac cul-de-sec.
- the balloon 700 is, after having delivered the adhesive and/or the substance for stimulating tissue growth to the tissue surface of a cardiac opening, removed from the cardiac opening and withdrawn from the patient along with the balloon catheter 612 . In this case, the cardiac opening is encouraged to heal itself.
- the closure system 600 includes, in some embodiments, a proximal locator 628 (i.e., a locator that is closest to a physician when the physician is using the closure system 600 ), an opposite, distal locator 630 , or both the proximal locator 628 and the distal locator 630 .
- a proximal locator 628 i.e., a locator that is closest to a physician when the physician is using the closure system 600
- an opposite, distal locator 630 or both the proximal locator 628 and the distal locator 630 .
- the locator 628 locates a proximal end of a cardiac opening.
- the locator 630 locates a distal end of the cardiac opening.
- the balloon 700 includes a proximal end 614 and an opposite, distal end 616 .
- the balloon 700 also includes a proximal opening 633 at its proximal end 614 , a distal opening 635 at its distal end 616 , and a lumen 631 extending from its proximal end 614 to its distal end 616 .
- the balloon catheter 612 includes a proximal end 618 , an opposite, distal end 620 , and a lumen 619 extending from the proximal end 618 to the distal end 620 .
- the balloon catheter 612 extends through the proximal opening 633 , through the lumen 631 , and through the distal opening 635 of the balloon 700 so that the entire balloon 700 is located between the proximal end 618 and the distal end 620 of the balloon catheter 612 .
- the portion of balloon catheter 612 located within the balloon 700 includes a plurality of holes 611 . Accordingly, the lumen 619 of the balloon catheter 612 is in fluid communication with the lumen 631 of the balloon 700 .
- the distal end 620 of the balloon catheter 612 is coupled to the proximal end 614 of the balloon 700 such that the lumen 619 of the balloon catheter 612 is contiguous with the lumen 631 of the balloon 700 .
- the distal end 620 of the balloon catheter 612 extends through the proximal opening 633 and is located within the lumen 631 of the balloon 700 .
- the balloon 700 is releasably coupled to the balloon catheter 612 .
- the balloon 700 is coupled to the balloon catheter 612 so that it may be separated from the balloon catheter 612 by applying a force, such as compression, tension, torsion, or any other type of force.
- the balloon 700 is left within the cardiac opening to assist in closing the cardiac opening.
- the balloon 700 is permanently coupled to the balloon catheter 612 for removal from the patient's body along with balloon catheter 612 .
- FIG. 14 also depicts a delivery catheter 622 having a lumen 624 .
- the physician first places a distal end 626 of the delivery catheter 622 in the patient's heart proximate the cardiac opening. The physician then places the closure system 600 in the lumen 624 of the delivery catheter 622 and advances the closure system 600 through the lumen 624 of the delivery catheter 622 until the closure system 600 exits the distal end 626 of the delivery catheter 622 , as shown. Methods of delivering the balloon 700 to the patient are described further below.
- FIGS. 15-17 depict the percutaneous transluminal closure system 600 for positioning the balloon 700 in a cardiac opening of a patient according to alternative illustrative embodiments of the invention.
- the closure system 600 includes, in one embodiment, an expandable proximal locator 628 for locating a proximal end of a cardiac opening.
- the locator 628 may be, as shown, coupled to the balloon catheter 612 , to the proximal end 614 of the balloon 700 , or to both the balloon catheter 612 and the balloon 700 .
- the locator 628 is a right atrial locator for locating a patent foramen ovale 44 from the right atrium 26 .
- the locator 628 When expanded, the locator 628 is configured to abut the tissue surfaces of the septum secundum 36 and the septum primum 30 from the right atrium 26 as the balloon 700 is placed within the patent foramen ovale 44 . Accordingly, the locator 628 locates the patent foramen ovale 44 .
- the locator 628 is used for locating an exterior tissue surface of a left atrial appendage 80 . In this case, the locator 628 is configured to abut the exterior tissue surface of the left atrial appendage 80 as the balloon 700 is placed within the left atrial appendage 80 .
- the closure system 600 includes an expandable distal locator 630 for locating a distal end of a cardiac opening. More specifically, the locator 630 is a left atrial locator for locating a patent foramen ovale 44 from the left atrium 32 .
- the locator 630 may be, as shown, coupled to the balloon catheter 612 , to the distal end 616 of the balloon 700 , or to both the balloon catheter 612 and the balloon 700 . In use, a physician advances the balloon 700 from the right atrium 26 , through the patent foramen ovale 44 , to the left atrium 32 .
- the locator 630 is configured to abut the tissue surfaces of the septum secundum 36 and the septum primum 40 from the left atrium 32 as the balloon 700 is placed within the patent foramen ovale 44 . Accordingly, the locator 630 locates the patent foramen ovale 44 and properly positions the balloon 700 within the patent foramen ovale 44 .
- the closure system 600 includes two locators, a proximal locator 628 and a distal locator 630 .
- the locators 628 , 630 may be made to expand by any of a variety of means.
- the locators 628 , 630 include a plurality of springs or resilient coils that cause them to expand.
- the locators 628 , 630 are balloons that are inflated.
- the locators 628 , 630 may be made from an elastomer material, such as a polyurethane or a silicone, from a biological material, such as a collagen or a bioresorbable polymer, or from other materials, such as synthetic materials.
- the locators 628 , 630 are made from a metallic material or a shape memory material, such as a shape memory alloy.
- a plurality of arms may form the locators 628 , 630 .
- the locators 628 , 630 may each be shaped as a disk, as illustrated for the distal locator 630 in FIG. 16 , as a balloon, as illustrated for the distal locator 630 in FIG. 17 , or as a rod, as illustrated for the proximal locator 628 in FIG. 17 .
- Any other geometry deemed suitable by one skilled in the art, such as, for example, a spiral wire, may also be used for the locators 628 , 630 .
- the locators 628 , 630 are releasably coupled to the balloon 700 and/or to the balloon catheter 612 .
- the locators 628 , 630 are coupled to the balloon 700 and/or to the balloon catheter 612 so that they may he separated from the balloon 700 and/or the balloon catheter 612 by applying a force, such as compression, tension, torsion, or any other type of force.
- the locators 628 , 630 are permanently coupled to the balloon 700 and/or to the balloon catheter 612 for removal from the patient's body along with the balloon 700 and/or the balloon catheter 612 .
- an adhesive 632 is coated on the locators 628 , 630 .
- the adhesive 632 may be used, for example, to bond the locators 628 , 630 to the wall of the septum secundum 36 and/or to the wall of the septum primum 40 when the balloon 700 is used to close a patent foramen ovale 44 .
- the adhesive 632 may be used to bond the proximal locator 628 to a tissue surface proximate a left atrial appendage 80 when the balloon 700 is used to obliterate the left atrial appendage 80 .
- the adhesive 632 may be, for example, a cyanoacrylate, a fibrin based adhesive, or an albumin gluteraldehyde type adhesive.
- FIG. 18 depicts an inflated balloon, generally 700 , having an outer surface 648 .
- an adhesive 656 is coated on the outer surface 648 of the balloon 700 a .
- FIG. 19 depicts the balloon 700 a deflated or partially deflated and
- FIG. 20 depicts a schematic cross-sectional view of the balloon 700 a of FIG. 19 taken along the line 19 - 19 .
- the balloon 700 a of the invention is coupled to the balloon catheter 612 , as described previously, and is initially delivered to a cardiac opening in a heart of a patient with the balloon 700 a deflated or partially deflated.
- the outer surface 648 of the deflated or partially deflated balloon 700 a is involuted to form a cavity 660 around the circumference of the outer surface 648 of the balloon 700 a .
- the midline 676 of the outer surface 648 of the balloon 700 a is pushed towards the inside of the balloon 700 a to form the cavity 660 .
- the edges 664 , 672 of the cavity 660 are folded to contact or overlap one another, as illustrated. By folding the balloon 700 a as such, the outer surface 648 of the balloon 700 a seals the cavity 660 from exposure to an outside environment 684 .
- adhesive 656 is coated on the surface of the cavity 660 of the deflated or partially deflated balloon 700 a . Accordingly, when the balloon 700 a is deflated or partially deflated, the adhesive 656 is also sealed from exposure to the outside environment 684 . By delivering the balloon 700 a to the patient's cardiac opening with the balloon 700 a deflated, the adhesive 656 is not exposed to the patient's blood and, according to one advantage of the invention, the risk of thrombus formation is thereby minimized. Once properly positioned within a patient's cardiac opening, the balloon 700 a may be inflated, thereby causing the involuted cavity 660 to unfold, as illustrated in FIG.
- the cavity 660 may encircle in any orientation any portion of the outer surface 648 of the balloon 700 a and in fact may be restricted to being simply an involuted pocket in a portion of the outer surface 648 of the balloon 700 a , as illustrated in FIG. 22 .
- FIG. 23 depicts an embodiment of a balloon 700 b .
- the balloon 700 b has an outer surface 748 .
- An expandable porous band 752 e.g., an elastic band 752 , having a plurality of openings 756 , encircles, in one embodiment, only a portion of the outer surface 748 of the balloon 700 b , such as the center portion 728 of the balloon 700 b .
- the expandable porous band 752 encircles other portions of the balloon 700 b .
- an adhesive 716 is disposed between the outer surface 748 of the balloon 700 b and the expandable porous band 752 .
- the expandable porous band 752 is designed such that, until the balloon 700 b is sufficiently inflated, the openings 756 of the porous band 752 are too small to allow any of the adhesive 716 to pass therethrough.
- FIG. 24 depicts a schematic cross-sectional view of the balloon 700 b of FIG. 23 taken along the line 23 - 23 .
- a cross-sectional diameter 760 of the center portion 728 of the balloon 700 b is, in one embodiment, slightly less than the inner circumference of the cardiac opening or the cardiac cul-de-sac that the balloon 700 b is to close.
- the center portion 728 of the balloon 700 b is designed to have, when nearly sufficiently inflated, a cross-sectional diameter 760 between approximately 1 millimeter and approximately 25 millimeters.
- the center portion 728 of the balloon 700 b is designed to have, when nearly sufficiently inflated, a cross-sectional diameter 760 between approximately 5 millimeters and approximately 25 millimeters.
- FIG. 25 depicts another embodiment of a balloon 700 c .
- Contained within the lumen 862 of the balloon 700 c is an adhesive 816 .
- the balloon 700 c has a plurality of holes 864 .
- the holes 864 are pores or slits. Until sufficiently inflated, the balloon 700 c will not have expanded and/or stretched to a point where the holes 864 are large enough to allow the adhesive 816 to pass therethrough.
- FIG. 26 depicts yet another illustrative embodiment of the invention.
- This embodiment includes two concentric balloons 700 d A, 700 d B and an adhesive 916 located within the lumen 962 B of the inner balloon 700 d B.
- the outer balloon 700 d A and the inner balloon 700 d B each include a plurality of holes (e.g., pores or slits) 964 A and 964 B, respectively.
- the further application of pressure to the balloon 700 b, c, or d enlarges the openings 756 of the porous band 752 , the holes 864 , or the holes 964 , respectively.
- the adhesive is thereby forced through the openings 756 , the holes 864 , or the holes 964 to the tissue surface of the cardiac opening or the cardiac cul-de-sac.
- a physician may apply the further pressure to the balloon 700 b, c, or d by further inflating the lumen of the balloon 700 b, c, or d .
- the physician pumps additional adhesive 816 through the lumen 619 of the balloon catheter 612 into the lumen 862 of the balloon 700 c .
- compression of a part of the balloon 700 b, c, or d by, for example, contacting the tissue surface of the cardiac opening or the cardiac cul-de-sac with that part of the balloon 700 b, c, or d , thus further inflating the remaining portions of the balloon 700 b, c, or d , will also cause the adhesive to be exposed to the tissue surface.
- the adhesive is only exposed to the patient's tissues in the area where the balloon 700 b, c, or d contacts the patient's tissues.
- the adhesive is only exposed in the area where the patient's tissues compress the balloon 700 b, c, or d .
- FIG. 27 depicts a balloon 700 e having a membrane 1088 constructed from a wicking material.
- the wicking material may be, for example, a natural fiber, such as cotton.
- an adhesive 1016 is absorbed within the wicking material of the balloon membrane 1088 .
- the adhesive 1016 is naturally drawn, by capillary action, to the outer surface 1008 of the balloon 700 e . Additionally, as shown, the adhesive 1016 may also be contained within a lumen 1062 of the balloon 700 e .
- the balloon 700 e is placed within, for example, the cardiac opening, contacting the tissue surface of the cardiac opening with the membrane 1088 of the balloon 700 e draws, by capillary action, further adhesive 1016 absorbed within the membrane 1088 to the outer surface 1008 of the balloon 700 e .
- the tissue surface of the cardiac opening is thereby coated with the adhesive 1016 .
- FIG. 28 depicts still another embodiment of the invention.
- a balloon 700 f has a first adhesive 1116 A coated on an outer surface 1108 of the balloon 700 f .
- a light source 1168 is located within the lumen 619 of the balloon catheter 612 and within a lumen of the balloon 700 f .
- the balloon catheter 612 may be translucent, or, alternatively, may includes holes in the region of the, light source 1168 , to allow the light emitted by the light source 1168 to propagate outside the balloon catheter 612 .
- the light source 1168 is, in one embodiment, a light bulb coupled through the balloon catheter 612 to a power supply. In another embodiment, the light source 1168 is an optical fiber connected at its other end to a source of illumination.
- a second adhesive 1116 B is coated on an inner surface 1112 of the balloon 700 f .
- the first adhesive 1116 A and/or the second adhesive 1116 B may each be, for example, a light activated adhesive, such as an adhesive curable with ultraviolet light.
- the first adhesive 1116 A and the second adhesive 1116 B may cover only a portion of the outer surface 1108 of the balloon 700 f and the inner surface 1112 of the balloon 700 f , respectively, as shown, or they may cover the entire outer surface 1108 and inner surface, respectively.
- the balloon 700 f is translucent.
- FIG. 29 depicts a schematic cross-sectional view of the balloon 700 f of FIG. 28 , taken along the line 28 - 28 .
- the balloon 700 f further includes, in one embodiment, a first non-reactive removable divider 1172 .
- the divider 1172 is coupled to the balloon 700 f so that one surface 1176 of the divider 1172 contacts the first adhesive 1116 A coated on the outer surface 1108 of the balloon 700 f .
- Coated on the second surface 1108 of the divider 1172 is a primer 1184 .
- the primer 1184 prepares the tissue surface of the patient to which the adhesive 1116 A will be applied.
- the primer 1184 helps to activate the adhesive 1116 A and/or bond the adhesive 1116 A to the patient's tissue surface.
- a second removable divider or temporary membrane covers the primer 1184 to protect it against premature exposure to blood.
- the second removable divider or temporary membrane may have attached to it sutures that can be pulled upon by the physician to remove it from the primer 1184 when the physician is ready to apply the primer 1184 to the tissues of the patient's cardiac opening.
- the first removable divider 1172 has attached to it sutures that can be pulled upon by the physician to remove it from the adhesive 1116 A when the physician is ready to apply the adhesive 1116 A to the tissues of the patient's cardiac opening.
- the balloons 700 described above may be tubularly-shaped. In alternative embodiments, the balloons 700 have other shapes, such as, for example, circular or rectangular shapes.
- the adhesives- coated on, or contained within, the balloons 700 of the invention may be, for example, cyanoacrylates, fibrin based adhesives, albumin gluteraldehyde type adhesives, or light activated adhesives. Alternatively, other adhesives, known to those skilled in the art, may be used.
- the balloons 700 include a substance for stimulating tissue growth.
- the growth substance may be combined with the adhesives of the balloons 700 or be used independently. In fact, the growth substance may be applied to, or be positioned within, the balloons 700 in the same manner as described above for the adhesives of the balloons 700 .
- the growth substance is, for example, a growth factor, such as a vascular endothelial growth factor, a basic fibro growth factor, or an angiogenic growth factor.
- the growth substance is a pharmacological agent for stimulating tissue growth, such as, for example, cells or genes.
- the growth substance is an irritant for encouraging an inflammatory response, such as, for example, cotton seed oil or alcohol.
- the balloons 700 a, b, c, d, and f described above are, in one embodiment, made from an elastomer material, such as, for example, a polylurethane or a silicone.
- the balloons 700 a, b, c, d, and f are made from a biological material, such as, for example, a collagen or a bioresorbable polymer.
- the balloons 700 a, b, c, d, and f are made from other materials.
- FIG. 30 depicts a closure system 600 according to still another illustrative embodiment of the invention.
- the exemplary closure system 600 includes the delivery catheter 622 described above, a sock catheter 612 ′, and a sock-shaped lining 634 .
- the lining 634 has an open end 636 , a closed end 637 , a first surface 638 , and a second surface 629 .
- the open end 636 of the lining 634 is coupled to the distal end 626 of the delivery catheter 622 and the closed end 637 of the lining 634 is coupled to the distal end 620 of the sock catheter 612 ′.
- the lining 634 is contained within the lumen 624 of the delivery catheter 622 , the first surface 638 forms an inner surface of the sock-shaped lining 634 , and the second surface 629 forms an outer surface of the sock-shaped lining 634 .
- the lining 634 inverts. Consequently, the first surface 638 now forms an outer surface of the sock-shaped lining 634 and the second surface 629 forms an inner surface of the sock-shaped lining 634 .
- an adhesive 639 similar to any of the adhesives used for the balloons 700 described above, is coated on the first surface 638 of the lining 634 .
- a physician advances the closure system 600 with the sock catheter 612 ′ retracted, as illustrated in FIG. 30 , and, once the closure system 600 is proximate a cardiac opening, the physician deploys the sock catheter 612 ′ so that it exits the distal end 626 of the delivery catheter 622 , as illustrated in FIG. 31 .
- the physician deploys the sock catheter 612 ′ by advancing (e.g., pushing) it distally or by withdrawing (e.g., pulling) the delivery catheter 622 proximally.
- the sock catheter 612 ′ is itself a balloon that may be expanded to exit the distal end 626 of the delivery catheter 622 .
- the lining 634 inverts to expose the first surface 638 and the adhesive 639 coated thereon to the patient's tissues.
- the lining 634 includes a plurality of holes (not shown).
- the adhesive 639 is coated on the second surface 629 of the lining 634 and/or is contained (e.g., absorbed) within the lining 634 itself.
- the lining 634 inverts and stretches, thereby enlarging the plurality of holes. Accordingly, the adhesive 639 may pass through the plurality of holes to the first surface 638 of the lining 634 for application to the patient's tissues.
- a substance for stimulating tissue growth as described above, is combined with the adhesive 639 or is used independently.
- the invention features methods for delivering a balloon 700 to a cardiac opening or a cardiac cul-de-sac in a patient and also methods for percutaneously closing the cardiac opening or obliterating the cardiac cul-de-sac using the delivered balloon 700 .
- FIGS. 32A-32D depict the steps of an illustrative method for delivering a balloon 700 of the invention to a cardiac opening in a patient.
- the cardiac opening illustrated in FIGS. 32A-32D is a patent foramen ovale 44 .
- the methods of the invention may also be used to obliterate a left atrial appendage 80 .
- a physician advances the delivery catheter 622 into the patient's heart and positions the distal end 626 of the delivery catheter 622 proximate the cardiac opening.
- the physician advances the balloon 700 and the balloon catheter 612 into and through the lumen 624 of the delivery catheter 622 .
- the physician continues to advance the balloon 700 until it and a distal portion of the balloon catheter 612 exit the distal end 626 of the delivery catheter 622 adjacent the cardiac opening, as illustrated in FIG. 32B .
- a deflated balloon 700 exits the distal end 626 of the delivery catheter 622 and is kept deflated until appropriately positioned within the cardiac opening.
- the balloon 700 is then inflated.
- the balloon 700 exits the distal end 626 of the delivery catheter 622 inflated, or, alternatively, exits deflated and is inflated by the physician prior to being positioned within the cardiac opening.
- the physician in one embodiment, expands the proximal locator 628 adjacent the cardiac opening.
- the physician advances the balloon 700 into the cardiac opening.
- the physician continues to advance the balloon 700 into the cardiac opening until the locator 628 abuts a tissue surface proximate cardiac opening.
- the physician advances the balloon 700 into the patent foramen ovale 44 until the locator 628 abuts the proximal walls of the septum secundum 36 and the septum primum 40 .
- the physician advances the balloon 700 into the left atrial appendage 80 until the locator 628 abuts the tissue surface of the heart proximate the left atrial appendage 80 . Having used the locator 628 to locate the cardiac opening, the physician then uses the locator 628 to correctly position the balloon 700 within the cardiac opening. In one embodiment, the balloon 700 is correctly positioned within the cardiac opening when the locator 628 abuts the tissue surface proximate the cardiac opening. In another embodiment, the physician proximally withdraws the locator 628 by a fixed amount from the tissue surface of the cardiac opening to correctly position the balloon 700 within the cardiac opening.
- FIGS. 33A-33E The methods described above for positioning the balloon 700 within a cardiac opening apply equally to positioning the balloon 700 within a patent foramen ovale 44 or a left atrial appendage 80 .
- FIGS. 33A-33E Other illustrative methods, specific to positioning a balloon 700 within a patent foramen ovale 44 , are illustrated in FIGS. 33A-33E .
- the physician advances the delivery catheter 622 into the patient's heart and through the patent foramen ovale 44 , thereby positioning the distal end 626 of the delivery catheter 622 in the left atrium 32 .
- the physician advances the balloon 700 into and through the lumen 624 of the delivery catheter 622 until the balloon 700 and a distal portion of the balloon catheter 612 exit the distal end 626 of the delivery catheter 622 into the left atrium 32 , as illustrated in FIG. 33B .
- the physician in one embodiment, expands the distal locator 630 , as illustrated in FIG. 33C .
- the physician withdraws the delivery catheter 622 and the balloon 700 proximally into the patent foramen ovale 44 .
- the physician continues to withdraw the delivery catheter 622 and the balloon 700 into the patent foramen ovale 44 until the locator 630 abuts the distal walls of the septum secundum 36 and the septum primum 40 , as illustrated in FIG. 33D .
- the physician positions the distal end 626 of the delivery catheter 622 in the left atrium 32 , as illustrated in FIG. 33A , rather than both deploying the balloon 700 and expanding the distal locator 630 in the left atrium 32 , as illustrated in FIG. 33C , the physician only expands the locator 630 in the left atrium 32 .
- the physician positions the locator 630 to abut the distal walls of the septum secundum 36 and the septum primum 40 . Once the locator 630 is positioned as such, the physician removes the delivery catheter 622 from about the balloon 700 to deploy the balloon 700 within the patent foramen ovale 44 , as illustrated in FIG. 33D .
- the physician when the balloon 700 is deployed within the patent foramen ovale 44 as illustrated in FIG. 33D , the physician then expands the proximal locator 628 in the right atrium 26 , as illustrated in FIG. 33E .
- the locators 628 and 630 are both balloons that are inflated in the right atrium 26 and the left atrium 32 , respectively. Together, the locators 628 and 630 may be used to correctly locate and position the balloon 700 within the patent foramen ovale 44 .
- the physician After the physician correctly positions the balloon 700 within the cardiac opening, as depicted in FIGS. 32D and 33E , the physician exposes the adhesive of the balloon 700 to the cardiac opening. As described above, the physician may accomplish this step in a variety of manners, depending on the type of balloon 700 that has been positioned within the cardiac opening.
- a deflated balloon 700 f is positioned within the cardiac opening and, subsequent to placement within the cardiac opening, is inflated, as illustrated in FIG. 28 .
- the physician first applies the primer 1184 to the patient's tissue surface within the cardiac opening. In one embodiment, the physician does so by contacting the patient's tissues within the cardiac opening with the primer 1184 contained on the second surface 1180 of the divider 1172 . The physician then removes the divider 1172 from about the balloon 700 f .
- the physician After applying the primer 1184 to the tissue surface of the cardiac opening and removing the divider 1172 , the physician further inflates the balloon 700 f to contact the tissue surface of the cardiac opening with the adhesive 1116 A.
- the physician simply inflates the balloon 700 f to contact the tissue surface of the cardiac opening with the adhesive 1116 A immediately following the placement of the balloon 700 f within the cardiac opening.
- the physician activates the adhesive 1116 A to cure the adhesive 1116 A to the patient's tissues.
- the physician illuminates the adhesive 1116 A to activate the adhesive 1116 A.
- the physician allows the adhesive to cure and to thereby glue the balloon 700 to the tissue surface within the cardiac opening or the cardiac cul-de-sac.
- the entire balloon 700 is coupled to the cardiac opening or the cardiac cul-de-sac to substantially occlude the cardiac opening or obliterate the cardiac cul-de-sac.
- the cardiac cul-de-sac is the left atrial appendage 80
- the physician may couple the entire balloon 700 to the tissue surface of the left atrial appendage 80 to substantially obliterate the left atrial appendage 80 .
- the physician allows the adhesive 1116 A to cure and to thereby couple the entire balloon 700 f to the tissue surface of the patent foramen ovale 44 .
- the physician may then separate and remove the balloon catheter 612 from the balloon 700 f and deflate the balloon 700 to draw the septum secundum 36 and the septum primum 40 together.
- the adhesive 1116 B which is coated on the inner surface 1112 of the balloon 700 f , glues portions of the inner surface 1112 of the balloon 700 f together.
- the physician may also couple the locators 628 , 630 to the tissue surface of the patient proximate the cardiac opening.
- the physician uses the adhesive 632 to glue the locators 628 , 630 to the tissue surface of the patient proximate the cardiac opening.
- the locators 628 , 630 therefore also aid in closing the cardiac opening.
- one or both locators 628 , 630 may be removed from the patient's body, even though the entire balloon 700 is coupled to the cardiac opening.
- the physician collapses the proximal locator 628 and removes it, along with the balloon catheter 612 , from the patient's body.
- the distal locator 630 is collapsed and proximally withdrawn, along with the balloon catheter 612 , through the distal opening 635 , through the lumen 631 , and through the proximal opening 633 of the balloon 700 for removal from the patient's body.
- the cardiac opening being closed is a patent foramen ovale 44
- the physician removes the balloon 700 , the balloon catheter 612 , and the one or more locators 628 , 630 from the patent foramen ovale 44 .
- the natural pressure difference between the right atrium 26 and the left atrium 32 will eventually cause the septum secundum 36 to contact the septum primum 40 .
- the septum secundum 36 and the septum primum 40 are coated with the adhesive, they will eventually bond together, thereby permanently closing the patent foramen ovale 44 .
- the physician while removing the balloon 700 from the patent foramen ovale 44 , the physician permanently glues one or both locators 628 and 630 to the tissue surface of the patient proximate the patent foramen ovale 44 .
- the locators 628 , 630 therefore also aid in closing the patent foramen ovale 44 .
- the substance for stimulating tissue growth is combined with the adhesive of the balloon 700 , or is used in place of the adhesive, and is delivered to, or impregnated within, the tissue surface of the patient's cardiac opening in a manner similar to that described above for the adhesives.
- the balloon 700 is used to deliver the growth substance to a patient's tissue surface located within a patent foramen ovale 44 .
- the balloon 700 is then removed from the patent foramen ovale 44 .
- the growth substance having been applied to the septum secundum 36 and the septum primum 40 , then stimulates tissue growth within the patent foramen ovale 44 .
- the newly grown tissue leads to the closure of the patent foramen ovale 44 .
- the invention provides methods for percutaneously closing a patent foramen ovale 44 using the exemplary closure system 600 depicted in FIGS. 30 and 31 .
- a physician advances the closure system 600 into the patient's heart with the sock catheter 612 ′ retracted, as illustrated in FIG. 30 .
- the physician then positions the distal end 626 of the delivery catheter 622 in the right atrium 26 proximate the patent foramen ovale 44 , as illustrated, for example, in FIG. 34A .
- the sock catheter 612 ′ is deployed to invert the lining 634 within the patent foramen ovale 44 .
- the adhesive 639 and/or the substance for stimulating tissue growth is exposed to the patient's tissue surface located within the patent foramen ovale 44 , as illustrated in FIG. 34B , and is applied thereto.
- the physician then retracts the sock catheter 612 ′ to remove the lining 634 from the patent foramen ovale 44 .
- the natural pressure difference between the right atrium 26 and the left atrium 32 causes the septum primum 36 and the septum secundum 30 to bond together, and/or natural tissue growth is stimulated within the patent foramen ovale 44 , thereby leading to closure of the patent foramen ovale 44 .
Landscapes
- Health & Medical Sciences (AREA)
- Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- General Health & Medical Sciences (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Animal Behavior & Ethology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Reproductive Health (AREA)
- Vascular Medicine (AREA)
- Cardiology (AREA)
- Physics & Mathematics (AREA)
- Plasma & Fusion (AREA)
- Otolaryngology (AREA)
- Surgical Instruments (AREA)
- Materials For Medical Uses (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
The invention generally relates to devices, systems, and methods for percutaneous closure of cardiac openings and obliteration of the cardiac cul-de-sacs. In one embodiment, a closure device includes a patch with an adhesive and/or a removable frame. The patch may be placed across a cardiac opening, such as a patent foramen ovale, or across a cardiac cul-de-sac, such as a left atrial appendage. In another embodiment, a closure device includes a balloon together with adhesives and/or substances for stimulating tissue growth coated on, or contained within, the balloon. The balloon may be inserted into a cardiac opening, such as the patent foramen ovale, or into a cardiac cul-de-sac, such as a left atrial appendage.
Description
- This application is a continuation application of U.S. application Ser. No. 11/045,027 filed Jan. 27, 2005, now issued as U.S. Pat. No. 8,262,694; which claims the benefit under 35 USC §119(e) to U.S. Application Ser. No. 60/540,827 filed Jan. 20, 2004, to U.S. Application Ser. No. 60/540,821 filed Jan. 30, 2004 and to U.S. Application Ser. No. 60/540,474 filed Jan. 30, 2004, all now expired. The disclosure of each of the prior applications is considered part of and is incorporated by reference in the disclosure of this application.
- 1. Field of the Invention
- The invention generally relates to devices, systems, and related methods for closing cardiac openings. More particularly, the invention features devices, systems, and related methods for the percutaneous transluminal closure of patent foramen ovales and left atrial appendages.
- 2. Background Information
- The human heart is divided into four compartments or chambers. The left and right atria are located in the upper portion of the heart and the left and right ventricles are located in the lower portion of the heart. The left and right atria are separated from each other by a muscular wall, the intraatrial septum, while the ventricles are separated by the intraventricular septum.
- Either congenitally or by acquisition, abnormal openings; holes, or shunts can occur between the chambers of the heart or the great vessels, causing blood to inappropriately flow therethrough. Such deformities are usually congenital and originate during fetal life when the heart forms from a folded tube into a four chambered, two-unit system. The septal deformities result from the incomplete formation of the septum, or muscular wall, between the chambers of the heart and can cause significant problems.
- One such septal deformity or defect, a patent foramen ovale, is a persistent, one-way, usually flap-like opening in the wall between the right atrium and left atrium of the heart. Since left atrial pressure is normally higher than right atrial pressure, the flap typically stays closed. Under certain conditions, however, right atrial pressure exceeds left atrial pressure, creating the possibility for right to left shunting that can allow blood clots to enter the systemic circulation. This is particularly problematic for patients who are prone to forming venous thrombus, such as those with deep vein thrombosis or clotting abnormalities.
- Moreover, certain patients are prone to atrial arrhythmias (i.e., abnormal heart rhythms which can cause the heart to pump less effectively). In a common such abnormality, atrial fibrillation, the two upper chambers of the heart (i.e., the left atria and the right atria), quiver instead of beating effectively. Because the atria do not beat and empty cleanly during atrial fibrillation, blood can stagnate on the walls and form clots that can then pass through the heart and into the brain, causing a stroke or a transient ischemic attack. These clots typically form in a cul-de-sac in the heart called the left atrial appendage due to its tendency to have low or stagnant flow.
- Nonsurgical (i.e., percutaneous) closure of a patent foramen ovale and similar cardiac openings such as an atrial septal defect or a ventricular septal defect, and obliteration' of a left atrial appendage can be achieved using a variety of mechanical closure devices. These closure devices typically consist of a metallic structural framework with a scaffold material attached thereto. Currently available closure devices, however, are often complex to manufacture, are inconsistent in performance, require a technically complex implantation procedure, lack anatomic conformability, and lead to complications (e.g., thrombus formation, chronic inflammation, residual leaks, perforations, fractures, and conduction system disturbances).
- Improved devices, systems, and related methods for closing cardiac openings, such as, for example, a patent foramen ovale, and for obliterating cardiac cul-de-sacs, such as, for example, a left atrial appendage, are, therefore, needed.
- The present invention provides devices, compounds, systems, and related methods for closing cardiac openings. A device of the invention may include, for example, a patch with an adhesive and/or a removable frame. The patch can be placed across a cardiac opening, such as a patent foramen ovale or a left atrial appendage, to substantially occlude the cardiac opening. Alternatively, in another aspect, the device includes a U-shaped patch, together with an adhesive, that is specifically configured for attachment to a septum secundum and closure of a patent foramen ovale.
- Moreover, in another aspect, a compound may be used to assist the device in closing, or may be used on its own to close, a cardiac opening. For example, a compound that includes an adhesive and a plurality of composite particles disposed within the adhesive may be used in that regard. In one embodiment, the plurality of composite particles disposed within the adhesive expand upon contact with blood and/or water, thereby locking the compound into place in the cardiac opening to substantially occlude the cardiac opening.
- In using the devices and compounds of the invention to close cardiac openings, the aforementioned disadvantages associated with the closure devices known in the art are minimized or eliminated.
- In one aspect, the invention provides a closure device for percutaneous transvascular closure of a cardiac opening. The closure device includes a patch, an adhesive coated on the patch, and at least one hollow channel enclosed within the patch.
- Various embodiments of this aspect of the invention include the following features. The patch may include a bioresorbable material and the adhesive may be a light activated adhesive, such as, for example, an adhesive curable with ultraviolet light. The hollow channel enclosed within the patch may, for its part, be a conduit for light. The closure device may further include a fiber optic cable, and/or a removable frame, enclosed within the hollow channel. In another embodiment, the closure device includes a divider that has first and second surfaces. The first surface is coupled to the adhesive and the second surface is coated with a primer.
- In another aspect, the invention relates to a method for percutaneous transluminal closure of a cardiac opening in a patient. The method includes inserting a closure device as described above into a heart of the patient and positioning the closure device across the cardiac opening to substantially occlude the cardiac opening.
- In various embodiments of this aspect of the invention, positioning the closure device across the cardiac opening includes coupling the closure device to a tissue surface of the patient proximate the cardiac opening. The cardiac opening may be, for example, a patent foramen ovale or a left atrial appendage. Coupling the closure device to the tissue surface may include providing light to the hollow channel enclosed within the patch and activating the adhesive coated on the patch with the provided light. In another embodiment, coupling the closure device to the tissue surface includes applying a primer to the tissue surface.
- In yet another aspect, the invention provides a closure device for percutaneous transluminal closure of a cardiac opening. The closure device includes a patch, at least one hollow channel enclosed within the patch, and a removable frame enclosed within the hollow channel.
- In one embodiment of this aspect of the invention, the patch is made from a collagen material. In another embodiment, the frame is constructed from a shape memory alloy, such as, for example, nitinol.
- In still another aspect, the invention relates to a method for percutaneous transluminal closure of a cardiac opening in a patient. The method includes inserting a closure device as immediately described above into a heart of the patient and positioning the closure device across the cardiac opening to substantially occlude the cardiac opening.
- In various embodiments of this aspect of the invention, positioning the closure device across the cardiac opening includes coupling the closure device to a tissue surface of the patient proximate the cardiac opening. The cardiac opening may be, for example, a patent foramen ovale or a left atrial appendage. In one embodiment, coupling the closure device to the tissue surface includes thermally welding the closure device to the tissue surface. In another embodiment, the frame of the closure device is removed from within the hollow channel after the closure device is thermally welded to the tissue surface.
- In another aspect, the invention provides a closure device for percutaneous transluminal closure of a cardiac opening. The closure device includes a housing, a releasable patch coupled to the housing, and an adhesive coated on the releasable patch.
- In one embodiment of this aspect of the invention, the housing is substantially conically shaped. In another embodiment, the releasable patch includes a bioresorbable material. The adhesive may be a light activated adhesive, such as, for example, an adhesive curable with ultraviolet light. In yet another embodiment, the closure device includes a light source enclosed within the housing. The light source may be, for example, a light bulb or a fiber optic cable. In still another embodiment, the closure device includes a divider that has first and second surfaces. The first surface is coupled to the adhesive and the second surface is coated with a primer.
- In yet another aspect, the invention relates to a method for percutaneous transluminal closure of a cardiac opening in a patient. The method includes inserting a closure device as immediately described above into a heart of the patient and positioning the releasable patch of the closure device across the cardiac opening to substantially occlude the cardiac opening.
- In various embodiments of this aspect of the invention, positioning the releasable patch of the closure device across the cardiac opening includes coupling the releasable patch to a tissue surface of the patient proximate the cardiac opening. The cardiac opening may be, for example, a patent foramen ovale or a left atrial appendage. Coupling the releasable patch of the closure device to the tissue surface may include providing a light source emitting light within the housing and activating the adhesive coated on the releasable patch with the emitted light. In another embodiment, coupling the releasable patch to the tissue surface includes applying a primer to the tissue surface. In yet another embodiment, coupling the releasable patch to the tissue surface includes separating the releasable patch from the housing.
- Additionally, in another aspect, the invention provides a closure device for percutaneous transvascular closure of a patent foramen ovale. The closure device includes a U-shaped patch configured for attachment to a septum secundum and an adhesive coated on the U-shaped patch.
- In one embodiment of this aspect of the invention, a substance for stimulating tissue in-growth into the closure device is coated on the U-shaped patch. The substance may be, for example, a growth factor, a pharmacological agent to stimulate tissue growth, an irritant to encourage an inflammatory response, cells, or genes. In another embodiment, a substance for increasing endothelization, or, alternatively, a substance for decreasing thrombogenicity, such as, for example, heparin, is coated on the U-shaped patch. In yet another embodiment, the closure device includes at least one barrier coupled to the U-shaped patch. The barrier may be a right atrial barrier for blocking an opening to the patent foramen ovale from the right atrium, or, alternatively, the barrier may be a left atrial barrier for blocking an opening to the patent foramen ovale from the left atrium.
- The U-shaped patch may include a biological material, a bioresorable material, a synthetic material, a polymeric material, a shape memory material, and/or a metallic mesh material. The adhesive may be, for example, cyanoacrylate and/or a fibrin based adhesive.
- In a further aspect, the invention provides a method for percutaneous transluminal closure of a patent foramen ovale in a patient. The method includes inserting a closure device into a heart of the patient and coupling the closure device to the septum secundum to substantially occlude the patent foramen ovale. The closure device includes a U-shaped patch configured for attachment to a septum secundum and an adhesive coated on the U-shaped patch.
- In one embodiment of this aspect of the invention, coupling the closure device to the septum secundum includes gluing the closure device to the septum secundum.
- In another aspect, the invention relates to a compound for percutaneous transluminal closure of a cardiac opening. The compound includes an adhesive and a plurality of composite particles disposed within the adhesive. The composite particles are capable of expansion upon contact with blood and/or water.
- In various embodiments of this aspect of the invention, the adhesive is a fibrin based adhesive. The composite particles may be, for example, gelatin particles, biological particles, bioresorbable particles, and/or foam particles.
- In yet another aspect, the invention provides a method for percutaneous transluminal closure of a cardiac opening in a patient. The method includes providing a compound as described above and injecting the compound into the cardiac opening to substantially occlude the cardiac opening.
- In one embodiment of this aspect of the invention, the method further includes positioning a patch or a barrier across an end of the cardiac opening, which may be, for example, a patent foramen ovale or a left atrial appendage.
- A device of the invention may further include specially designed balloons together with adhesives and/or substances for stimulating tissue growth coated on, or contained within, the specially designed balloons. According to one feature of the invention, the specially designed balloons ensure that the adhesives are only exposed once the balloons are located within the cardiac openings. Advantageously, the adhesives are exposed only to the tissue surface of the cardiac openings and not to a patient's blood prior to locating the balloons within the cardiac openings. By minimizing the exposure of the adhesives to blood, the risk of thrombus formation is reduced.
- According to another feature of the invention, closure systems employ one or more locators for initially locating the cardiac openings and then properly positioning the balloons of the invention within the cardiac openings. Knowing that a balloon is properly positioned within a cardiac opening allows a physician to release the adhesive contained within the balloon at the appropriate time. As such, the risk of exposing the adhesive prior to locating the balloon within the cardiac opening, and the consequent risk of thrombus formation, is again reduced.
- In one aspect, the invention provides a closure device for percutaneous transluminal closure of a cardiac opening. The closure device includes a balloon, which has an outer surface, and an adhesive. The balloon is inflatable between a deflated state and an inflated state. In the deflated state, the outer surface of the balloon involutes to form a cavity and the adhesive is coated on a surface of the cavity. In the inflated state, the cavity unfolds to form the outer surface of the balloon and the adhesive is coated on the outer surface of the balloon.
- In one embodiment of this aspect of the invention, the cavity is formed around a mid-portion of the balloon, which may be tubularly-shaped. In another embodiment, the closure device further includes a substance for stimulating tissue growth. In the deflated state of the balloon, the growth substance is coated on the surface of the cavity. In the inflated state of the balloon, the growth substance is coated on the outer surface of the balloon.
- In another aspect, the invention relates to a method for percutaneous transluminal closure of a cardiac opening in a patient. The method includes inserting a closure device as described above into a heart of the patient, positioning the closure device within the cardiac opening with the balloon of the closure device deflated, and inflating the balloon to expose the adhesive coated on the outer surface of the balloon to the cardiac opening. In one embodiment of this aspect of the invention, the balloon of the closure device is removed from the patient after the adhesive is exposed to the cardiac opening.
- In yet another aspect, the invention provides a closure device that includes a balloon having an outer surface, a porous band encircling only a portion of the outer surface of the balloon, and an adhesive disposed between the outer surface of the balloon and the porous band. The porous band has a plurality of openings.
- In one embodiment of this aspect of the invention, the porous band encircles a center portion of the balloon, which may be, for example, tubularly-shaped. In another embodiment, a substance for stimulating tissue growth is disposed between the outer surface of the balloon and the porous band.
- In still another aspect, the invention relates to a method that includes inserting a closure device as just described into a heart of the patient, positioning the closure device within the cardiac opening, and applying a pressure to the balloon of the closure device to expose the adhesive through the plurality of openings of the porous band to the cardiac opening. In one embodiment of this aspect of the invention, the balloon and the porous band of the closure device are removed from the patient after the adhesive is exposed through the plurality of openings of the porous band to the cardiac opening.
- Additionally, in another aspect, the closure device includes an outer balloon that has a plurality of first holes, an inner balloon that has a plurality of second holes, and an adhesive. The adhesive is contained within the inner balloon, which is itself contained within the outer balloon.
- In various embodiments of this aspect of the invention, at least one of the plurality of first holes and the plurality of second holes includes pores. Alternatively, in another embodiment, at least one of the plurality of first holes and the plurality of second holes includes slits. In yet another embodiment, at least one of the inner balloon and the outer balloon is tubularly-shaped. In another embodiment, a substance for stimulating tissue growth is contained within the inner balloon.
- In a further aspect, the invention relates to a method that includes inserting a closure device as just described into a heart of the patient, positioning the closure device within the cardiac opening, applying a first pressure to the inner balloon to express the adhesive through the plurality of second holes, and applying a second pressure to the outer balloon to express the adhesive through the plurality of first holes to the cardiac opening. In one embodiment of this aspect of the invention, the outer balloon and the inner balloon of the closure device are removed from the patient after the adhesive is expressed through the plurality of first holes to the cardiac opening.
- In another aspect, the closure device includes a balloon and an adhesive. The balloon has a membrane constructed from a wicking material and the adhesive is contained within the membrane of the balloon.
- In one embodiment of this aspect of the invention, the balloon is tubularly-shaped. In another embodiment, a substance for stimulating tissue growth is contained within the membrane of the balloon. At least a portion of the adhesive and/or the substance for stimulating tissue growth may be absorbed within the membrane of the balloon.
- In yet another aspect, the invention relates to a method that includes inserting a closure device as just described into a heart of the patient, positioning the closure device within the cardiac opening, and contacting a tissue surface of the cardiac opening with the membrane of the balloon to apply the adhesive to the tissue surface of the cardiac opening. In one embodiment of this aspect of the invention, the balloon of the closure device is removed from the patient after the adhesive is applied to the tissue surface of the cardiac opening.
- In various embodiments of the foregoing aspects of the invention, the adhesives are cyanoacrylates, fibrin based adhesives, albumin gluteraldehyde type adhesives, or light activated adhesives. Moreover, the substances for stimulating tissue growth may be, for example, growth factors, pharmacological agents for stimulating tissue growth, irritants for encouraging an inflammatory response, cells, or genes. The cardiac opening is, for example, a patent foramen ovale or a left atrial appendage.
- In still another aspect, the invention relates to a method for percutaneous transluminal closure of a left atrial appendage in a patient. The method includes inserting a closure device into a heart of the patient and positioning the closure device within the left atrial appendage. The closure device includes a balloon having a plurality of holes and an adhesive contained within the balloon. The method further includes applying a pressure to the balloon to separate the plurality of holes and to expose the adhesive to the left atrial appendage. The method also includes coupling the balloon of the closure device to the left atrial appendage with the exposed adhesive.
- Additionally, in another aspect, the invention provides a closure device that includes a balloon with an outer surface, a first adhesive coated on the outer surface of the balloon, and a light source located within the balloon.
- In one embodiment of this aspect of the invention, the closure device further includes a second adhesive coated on an inner surface of the balloon. At least one of the first adhesive and the second adhesive may be a light activated adhesive. In another embodiment, the closure device further includes a divider having first and second surfaces. The first surface of the divider may be coupled to the first adhesive and the second surface of the divider may be coated with a primer. The balloon may be made of an elastomer, or, alternatively, a biological material, which may be, for example, a collagen or a bioresorbable polymer. The balloon may be tubularly-shaped.
- In a further aspect, the invention relates to a method that includes inserting a closure device as just described into a heart of the patient, positioning the closure device within the cardiac opening, and coupling the closure device to the cardiac opening to substantially occlude the cardiac opening.
- In various embodiments of this aspect of the invention, coupling the closure device to the cardiac opening includes inflating the balloon, emitting light from the light source located within the balloon, and activating the adhesive coated on the outer surface of the inflated balloon with the emitted light. The inflated balloon may then be deflated and left behind in the cardiac opening. Coupling the closure device to the cardiac opening may also include applying a primer to a tissue surface of the cardiac opening. The cardiac opening may be, for example, a patent foramen ovale or a left atrial appendage.
- In another aspect, the invention provides a percutaneous transluminal system for positioning a closure device in a cardiac opening. The system includes a catheter, a closure device coupled to the catheter, and a first locator coupled to at least one of the catheter and the closure device. The first locator is for positioning the closure device within the cardiac opening.
- In various embodiments of this aspect of the invention, the first locator is a disk, a plurality of arms, a rod, or a balloon. The first locator may be, for example, a right atrial locator or a left atrial locator. In one embodiment, an adhesive, such as, for example, a cyanoacrylate, a fibrin based adhesive, or an albumin gluteraldehyde type adhesive, is coated on the first locator. In another embodiment, the system further includes a second locator coupled to at least one of the catheter and the closure device. The second locator is also for positioning the closure device within the cardiac opening.
- In one embodiment, the system further includes an adhesive coupled to the closure device. Again, the adhesive may be, for example, a cyanoacrylate, a fibrin based adhesive, or an albumin gluteraldehyde type adhesive. The adhesive coupled to the closure device may alternatively be a light activated adhesive and the system may further include a light source coupled to the catheter for activating the light activated adhesive.
- In another embodiment, the closure device is a balloon, which may be, for example, tubularly-shaped, hi one embodiment, the balloon includes a first end, a second end, and a lumen extending from the first end to the second end. hi another embodiment, the balloon includes a first opening at the first end of the balloon and a second opening at the second end of the balloon. In yet another embodiment, the balloon comprises a plurality of holes. An adhesive may be coated on an outer surface of the balloon, coated on an inner surface of the balloon, or simply contained within the lumen of the balloon.
- In still another aspect, the invention relates to a method for delivering a closure device to a cardiac opening in a patient. The method includes inserting, into a heart of the patient, a system for positioning the closure device within the cardiac opening. The system is as just described. The first locator of the system is used to locate the cardiac opening and also to position the closure device within the cardiac opening,
- In various embodiments of this aspect of the invention, the method further includes coupling the closure device to the cardiac opening to substantially occlude the cardiac opening. The method may also include coupling the first locator to a tissue surface of the patient that is proximate the cardiac Opening. The cardiac opening may be, for example, a patent foramen ovale or a left atrial appendage.
- Additionally, in another aspect, the invention provides a percutaneous transluminal system for closing a cardiac opening. The system includes a first catheter having a proximal end, a distal end, and a lumen extending from the proximal end to the distal end, a second catheter at least partially enclosed within the lumen of the first catheter, and a lining coupled to the first and second catheters. The second catheter is movable between a retracted state and a deployed state. In the retracted state of the second catheter, the lining is positioned within the lumen of the first catheter. In the deployed state of the second catheter, the lining inverts and is positioned outside the lumen of the first catheter.
- In various embodiments of this aspect of the invention, the lining is sock-shaped. Moreover, adhesives and/or substances for stimulating tissue growth, of the types described above, may be coated on a surface of the lining and/or contained within the lining itself.
- In a further aspect, the invention relates to a method for percutaneous transluminal closure of a cardiac opening in a patient. The method includes inserting a system as just described into a heart of the patient, positioning the system proximate the cardiac opening with the second catheter in a retracted state, and deploying the second catheter to invert the lining and position the lining within the cardiac opening.
- In one embodiment of this aspect of the invention, the system further includes an adhesive coated on a surface of the lining and the adhesive is exposed to the cardiac opening when the second catheter is deployed. In another embodiment, the lining includes a plurality of holes and the system further includes an adhesive contained within the lining. In such an embodiment, the adhesive is exposed through the plurality of holes to the cardiac opening when the second catheter is deployed. In yet another embodiment, the system is removed from the patient after the adhesive is exposed to the cardiac opening, which may be, for example, a patent foramen ovale.
- The foregoing and other aspects, features, and advantages of the invention will become more apparent from the following description taken in conjunction with the accompanying drawings.
- In the drawings, like reference characters generally refer to the same parts throughout the different views. Also, the drawings are not necessarily to scale, emphasis instead generally being placed upon illustrating the principles of the invention.
-
FIG. 1 is a cutaway view of a heart illustrating a patent foramen ovale. -
FIG. 2 is a partial cross-sectional view of another heart illustrating a left atrial appendage. -
FIG. 3 is a schematic perspective view of a system, including a delivery catheter and a closure device, for the percutaneous transluminal closure of a cardiac opening according to an illustrative embodiment of the invention. -
FIGS. 4A-4B illustrate extended and folded configurations of a frame for the closure device illustrated inFIG. 3 , according to an illustrative embodiment of the invention. -
FIG. 5 is a schematic perspective view of a system, including a delivery catheter and a closure device, for the percutaneous transluminal closure of a cardiac opening according to another illustrative embodiment of the invention. -
FIG. 6 is a schematic cross-sectional view of a system, including a delivery catheter and a closure device, for the percutaneous transluminal closure of a cardiac opening according to another illustrative embodiment of the invention. -
FIG. 7 is a schematic side view of a closure device for the percutaneous transluminal closure of a cardiac opening according to another illustrative embodiment of the invention. -
FIG. 8 is a schematic side view of a closure device, according to another illustrative embodiment of the invention, coupled to the septum secundum and the septum primum of a patent foramen ovale. -
FIG. 9 is a schematic side view of a closure device, according to another illustrative embodiment of the invention, coupled to the septum secundum and the septum primum of a patent foramen ovale. -
FIG. 10 is a schematic side view of a closure device, according to another illustrative embodiment of the invention, coupled to the septum secundum and the septum primum of a patent foramen ovale. -
FIGS. 11A-11C illustrate the stages, according to an illustrative embodiment of the invention, for closing a patent foramen ovale in a patient. -
FIG. 11D illustrates a left atrial appendage closed according to an illustrative embodiment of the invention. -
FIG. 11E-11F illustrates the stages, according to another illustrative embodiment of the invention, for closing a patent foramen ovale in a patient. -
FIG. 12 is a schematic side view of the illustrative closure device ofFIG. 7 coupled to the septum secundum of a patent foramen ovale. -
FIG. 13 illustrates a compound for the percutaneous transluminal closure of a cardiac opening according to an illustrative embodiment of the invention. -
FIG. 14 is a schematic side view of a closure system according to an illustrative embodiment of the invention. -
FIG. 15 is a schematic perspective view of a closure system according to another illustrative embodiment of the invention. -
FIG. 16 is a schematic side view of a closure system according to another illustrative embodiment of the invention. -
FIG. 17 is a schematic side view of a closure system according to another illustrative embodiment of the invention. -
FIG. 18 is a schematic perspective view of an inflated balloon according to an illustrative embodiment of the invention. -
FIG. 19 is a schematic perspective view of the illustrative balloon ofFIG. 17 deflated according to an illustrative embodiment of the invention. -
FIG. 20 is a schematic cross-sectional view of the illustrative balloon ofFIG. 19 taken along the line 19-19. -
FIG. 21 is a schematic cross-sectional view of the illustrative balloon ofFIG. 20 inflated according to an illustrative embodiment of the invention. -
FIG. 22 is a schematic perspective view of a deflated balloon according to another illustrative embodiment of the invention. -
FIG. 23 is a schematic perspective view of a balloon according to another illustrative embodiment of the invention. -
FIG. 24 is a schematic cross-sectional view of the illustrative balloon ofFIG. 23 taken along the line 23-23. -
FIG. 25 is a schematic cross-sectional view of a balloon according to another illustrative embodiment of the invention. -
FIG. 26 is a schematic cross-sectional view of concentric balloons according to another illustrative embodiment of the invention. -
FIG. 27 is a schematic cross-sectional view of a balloon according to another illustrative embodiment of the invention. -
FIG. 28 is a schematic cross-sectional view of a balloon according to another illustrative embodiment of the invention. -
FIG. 29 is a schematic cross-sectional view of the illustrative balloon ofFIG. 28 taken along the line 28-28. -
FIG. 30 is a schematic side view of a closure system, including a retracted sock catheter, according to another illustrative embodiment of the invention. -
FIG. 31 is a schematic side view of the illustrative closure system ofFIG. 30 , including a deployed sock catheter. -
FIGS. 32A-32D illustrate the stages, according to an illustrative embodiment of the invention, for closing a patent foramen ovale in a patient. -
FIGS. 33A-33E illustrate the stages, according to another illustrative embodiment of the invention, for closing a patent foramen ovale in a patient. -
FIGS. 34A-34B illustrate the stages, according to another illustrative embodiment of the invention, for closing a patent foramen ovale in a patient. - The present invention features devices, systems, and related methods for closing cardiac openings, such as, for example, the patent foramen ovale described below, arid for obliterating cardiac cul-de-sacs, such as, for example, the left atrial appendage described below.
-
FIG. 1 depicts a cutaway view of aheart 20. Theheart 20 includes aseptum 24 that divides aright atrium 26 from aleft atrium 32. Theseptum 24 includes aseptum secundum 36 and aseptum primum 40. An exemplary cardiac opening, apatent foramen ovale 44, that is to be corrected by the devices, systems, and related methods of the present invention is located between theseptum secundum 36 and theseptum primum 40. Thepatent foramen ovale 44 provides an undesirable fluid communication between theright atrium 26 and theleft atrium 32 and, under certain conditions, allows for the shunting of blood between theright atrium 26 and theleft atrium 32. If thepatent foramen ovale 44 is not closed or obstructed in some manner, a patient is placed at a higher risk for an embolic stroke in addition to other circulatory abnormalities. -
FIG. 2 depicts a partial cross-sectional view of anotherheart 60. Theheart 60 includes anaorta 64, aleft ventricle 68, aleft atrium 72, and afossa ovalis 76. Theheart 60 also includes an exemplary cardiac cul-de-sac, a leftatrial appendage 80, that is to be obliterated by the devices, systems, and related methods of the present invention. Under certain conditions, blood clots may form in the leftatrial appendage 80. If the leftatrial appendage 80 is not closed or obstructed in some manner, a patient is placed at a higher risk of having the blood clots pass from theheart 60 and into the vasculature of the brain, causing a stroke or a transient ischemic attack. - In broad overview, embodiments of the devices of the invention typically include a patch or a balloon. Referring to embodiments that include a patch, an adhesive maybe coated on the patch and the adhesive may require activation (e.g., light activation) to bond the patch to a patient's tissue surface. In one embodiment, to close a patient's cardiac opening, the patch is placed across the cardiac opening and the adhesive activated to bond the patch to the patient's tissue. The cardiac opening is thereby substantially occluded.
- In another embodiment, a removable frame is enclosed within the patch. In one such embodiment, to substantially occlude the cardiac opening, the patch is placed across the cardiac opening and thermally welded to the patient's tissue. The frame is then removed from the patch.
- In yet another embodiment, the patch is a U-shaped patch that is bonded to a septum secundum of a patent foramen ovale. The U-shaped patch includes, for example, a barrier that is attached to a septum primum to substantially occlude the patent foramen ovale. Alternatively, the U-shaped patch includes, for example, a substance that stimulates tissue growth from the septum secundum and/or the septum primum. In such a case, the patent foramen ovale is encouraged to heal itself.
- Compounds of the invention may be employed on their own, or in conjunction with the devices of the invention, to occlude the cardiac openings described herein. Typically, the compounds are first physically injected or otherwise applied into the cardiac openings and thereafter expand to substantially occlude the cardiac openings.
-
FIG. 3 depicts asystem 100, capable of being used for the percutaneous transluminal closure of a cardiac opening, according to an illustrative embodiment of the invention. Thesystem 100 includes aclosure device 104 and adelivery catheter 108 that is used to deliver theclosure device 104 to the cardiac opening in a patient's heart. In one embodiment, thedelivery catheter 108 includes a proximal end 112 (i.e., an end that is closest to a physician when the physician is using the system 100), an opposite,distal end 116, and alumen 120 that extends from theproximal end 112 to thedistal end 116. - For its part, in one embodiment, the
closure device 104 includes apatch 124 and at least onehollow channel 136 enclosed within thepatch 124. For example, as illustrated, thepatch 124 includes a plurality ofhollow channels 136 extending from a common center similar to spokes of a wheel. Theclosure device 104 is coupled to thedistal end 116 of thedelivery catheter 108 such that thelumen 120 of thedelivery catheter 108 is contiguous with thehollow channels 136 enclosed withinpatch 124. In one embodiment, theclosure device 104 is releasably coupled to thedistal end 116 of thedelivery catheter 108. For example, theclosure device 104 is coupled to thedistal end 116 of thedelivery catheter 108 so that it may be separated from thedelivery catheter 108 through the application of a force, such as a torsional force applied by the physician to theproximal end 112 of thedelivery catheter 108 and transmitted along thedelivery catheter 108 to the point of coupling with theclosure device 104. - The
lumen 120 of thecatheter 108 and thehollow channels 136 may be used, for example, as conduits to channel light through thedelivery catheter 108 and thepatch 124. In one embodiment, for example, a physician using thesystem 100 positions a light source (not shown) proximal to theproximal end 112 of thedelivery catheter 108, or at some other point within thelumen 120 of thedelivery catheter 108, and projects light down thelumen 120 and through thehollow channels 136 of thepatch 124. Alternatively, in another embodiment, thelumen 120 and thehollow channels 136 enclose one or more fiber optic cables for delivering light through thedelivery catheter 108 and thepatch 124. In such a case, the fiber optic cables are connected at their proximal ends to a source of illumination. The light serves to activate adhesive 128 to bond thepatch 124 to a patient's tissue. - Referring to
FIG. 4A , in yet another embodiment, thelumen 120 and thehollow channels 136 enclose acontinuous frame 110. Theframe 110 may be constructed from a shape memory alloy, such as, for example, from nitinol or, alternatively from a polymer, stainless steel, or any combination of the above materials. In one embodiment, theframe 110 is used as a means for expanding thepatch 124 of theclosure device 104 and as a means for holding thepatch 124 flush against a patient's tissue surface proximate the cardiac opening. In a further embodiment, theframe 110 may include a plurality of arms having springs orresilient coils 113 that cause theclosure device 104 to expand. Referring toFIG. 4B , in one embodiment, a physician advances asheath 400 into a patient's heart and positions thedistal end 404 of the sheath proximate the cardiac opening. This is described below with reference toFIGS. 11A and 11B . During advancement of theclosure device 104 through thesheath 400, thearms 111 offrame 110 may bend at the springs orresilient coils 113 to facilitate passage of the closure device through thesheath 400. Theframe 110 may also be coupled at its proximal end to a power supply and used to deliver radio frequency energy to a tissue surface proximate the cardiac opening. - In a particular embodiment, the fiber optic cables and/or the
frame 110 may be removable from thepatch 124 after thepatch 124 is coupled to a patient's tissues proximate the cardiac opening. For example, the fiber optic cables and/or theframe 110 may be retracted from thehollow channels 136 of thepatch 124 into thecontiguous lumen 120 of thedelivery catheter 108. - Referring again to
FIG. 3 , in one embodiment, an adhesive 128 is applied to thepatch 124 as a coaling. For example, the adhesive 128 is coated on adistal side 132 of thepatch 124, or, alternatively, on aproximal side 130 of the patch 124 (not shown). The adhesive 128 may be, for example, a light activated adhesive, such as an adhesive curable with ultraviolet light. To bond thepatch 124 to a patient's tissue surface proximate the cardiac opening, light may be delivered through thedelivery catheter 108 and thepatch 124 to the adhesive 128 and used to activate the adhesive 128. - Alternatively in still other embodiments, the adhesive 128 may be a heat activated adhesive, a chemically activated adhesive, or a bioreactive adhesive. In such alternative embodiments, the
lumen 120 andhollow channels 136 are used to deliver heat, chemicals, or biological agents, respectively, to the adhesive 128. For example, thelumen 120 andhollow channels 136 may enclose a pipe to bidirectionally carry hot- water proximate a heat activatedadhesive 128. Alternatively, radio frequency energy (delivered, for example, by theframe 110 enclosed within thelumen 120 and the hollow channels 136), electrical resistance, ultrasound energy, laser energy, or chemical energy may be supplied to the heat activated adhesive 128. - In yet another embodiment, the adhesive 128, rather than being initially coated on the
distal side 132 or on theproximal side 130 of thepatch 124, is introduced to thedistal side 132 or to theproximal side 130 of thepatch 124 via thelumen 120 and thehollow channels 136. For example, in one embodiment illustrated inFIG. 3 , holes 137, which pass from thehollow channels 136 to the surface of thepatch 124, are present on thedistal side 132 or on theproximal side 130 of thepatch 124 in the region of thehollow channels 136. When the physician is ready to adhere thepatch 124 to the patient's tissues proximate the intracardiac defect, the physician injects the adhesive 128 through thelumen 120, through thehollow channels 136, and through theholes 137 to the surface of thedistal side 132 or the surface of theproximal side 130 of thepatch 124. - In embodiments where the
patch 124 includes the adhesive 128, thepatch 124 may be made, either entirely or in part, from a biological material, a bioresorbable material (e.g., polylactide, glycolide, or caprolactone), a synthetic material (e.g., polyester, expanded polytetrafluoroethylene (ePTFE), or polyvinyl alcohol), a polymeric material, a shape memory material (e.g., a shape memory alloy), a metal mesh, or other suitable material for closing a cardiac opening, such as combinations of these materials. Moreover, portions of thepatch 124 proximate thehollow channels 136 may be made from a translucent material. - In some embodiments, the
closure device 104 is devoid of the adhesive 128. In such embodiments, radio frequency energy is delivered via theframe 110 and thepatch 124 is thermally welded to a patient's tissue surface proximate the cardiac opening. In such embodiments, thepatch 124 is typically made from a biological material. For example, thepatch 124 is made from a collagen based material derived from the intestine, stomach, skin, bladder, or pericardium of a porcine animal, a bovine animal, and/or a human. - Referring still to
FIG. 3 , thepatch 124 may be disk-shaped and have a circular cross-section. Alternatively, thepatch 124 may have a variety of other cross-sectional shapes suitable for closing a cardiac opening, including, but not limited to, rectangular and triangular. Thepatch 124 may also include one or more radio-opaque markers or radio-opaque fillers to indicate its position within a patient's body. -
FIG. 5 depicts asystem 100, capable of being used for the percutaneous transluminal closure of a cardiac opening, according to another illustrative embodiment of the invention. As shown, theclosure device 104 of thesystem 100 further includes aremovable divider 144, such as, for example, anon-reactive sheet 144, having afirst surface 148 and asecond surface 152. In the context ofdivider 144, non-reactive means that the divider does not appreciably adhere to adhesive 128, nor interact with material, such as a primer, that may be coated onto a surface ofdivider 144. Thefirst surface 148 of theremovable divider 144 contacts the adhesive 128 of theclosure device 104. Coated on thesecond surface 152 of theremovable divider 144 is aprimer 156. In one embodiment, theprimer 156 prepares the tissue surface of the patient to which theclosure device 104 will be adhered during the process of closing the patient's cardiac opening. In another embodiment, theprimer 156 helps to activate the adhesive 128 and/or bond the adhesive 128 to the patient's tissue surface. After application of theprimer 156 to the tissue surface proximate the cardiac opening, theremovable divider 144 may be removed from the rest of theclosure device 104. In one embodiment, sutures 145, illustrated inFIG. 5 , are attached to theremovable divider 144 at apoint 146 on the edge of theremovable divider 144. The physician may remove theremovable divider 144 from the rest of theclosure device 104 by applying traction to theproximal end 147 of the suture, and withdrawing theremovable divider 144 through aperforation 149 in thedelivery catheter 108. - In one embodiment, illustrated in
FIG. 5 , the adhesive 128 is coated on adistal side 132 of thepatch 124. Theremovable divider 144 and theprimer 156 are therefore also located distal to thepatch 124. Alternatively, in another embodiment, the adhesive 128 is coated oil aproximal side 130 of the patch 124 (not shown). In such an embodiment, theremovable divider 144 and theprimer 156 are located proximal to thepatch 124. -
FIG. 6 depicts asystem 200, capable of being used for the percutaneous transluminal closure of a cardiac opening, according to another illustrative embodiment of the invention. Thesystem 200 includes aclosure device 204 and adelivery catheter 208 that is used to deliver theclosure device 204 to the cardiac opening in a patient's heart. Thedelivery catheter 208 includes a proximal end 212 (i.e., an end that is closest to a physician when the physician is using the system 200) and an opposite,distal end 216. In one embodiment, theclosure device 204 includes ahousing 222, areleasable patch 224 coupled to adistal surface 226 of thehousing 222, and an adhesive 228 coated on adistal side 232 of thereleasable patch 224. - In one embodiment, as illustrated in
FIG. 6 , thehousing 222 is conically shaped, with thedistal surface 226 of thehousing 222 forming the base of the cone and the apex 218 of the cone being coupled to thedistal end 216 of thedelivery catheter 208. Alternatively, thehousing 222 may be otherwise shaped, for example as a tetrahedron with thedistal surface 226 of thehousing 222 forming the triangular base of the tetrahedron and the apex 218 of the tetrahedron being coupled to thedistal end 216 of thedelivery catheter 208. Enclosed within thehousing 222 is, in one embodiment, alight source 236. Thelight source 236 may be, for example, a light bulb or a fiber optic cable that is used to deliver light to, for example, a light activated adhesive 228 located at thedistal surface 226 of thehousing 222. - As described above for the
closure device 104, thereleasable patch 224 of theclosure device 204 may be made, either entirely or in part, from biological materials, bioresorbable materials, synthetic materials, polymeric materials, shape memory materials, and/or metal meshes. Moreover, portions of thereleasable patch 224 may be made from a translucent material and may include one or more radio-opaque markers or radio-opaque fillers to indicate the anatomical position of thereleasable patch 224 within a patient's body. - Referring still to
FIG. 6 , thereleasable patch 224 of theclosure device 204 may be disk-shaped and have a circular cross-section to match the shape of thedistal surface 226 of thehousing 222. Alternatively, thereleasable patch 224 may have a variety of other cross- sectional shapes suitable for closing a cardiac opening Where, for example, thehousing 222 is shaped as a triangular prism, thereleasable patch 224 may have a triangular or rectangular cross-section to match the shape of thedistal surface 226 of thehousing 222. - In one embodiment according to the invention, the adhesive 228, coated to the
distal side 232 of thereleasable patch 224, is a light activated adhesive. For example, the adhesive 228 is an adhesive curable with ultraviolet light. Alternatively, in other embodiments, the adhesive 228 may be a heat activated adhesive, a chemically activated adhesive, or a bioreactive adhesive. In such alternative embodiments, thelight source 236 is replaced by other devices. For example, to deliver heat to a heat activated adhesive 228, a pipe may be used to bidirectionally carry hot water proximate the heat activated adhesive 228. Alternatively, electrical resistance, radio frequency energy, ultrasound energy, laser energy, or chemical energy is delivered to a heat activatedadhesive 228. In still other embodiments, chemicals are delivered to a chemically activated adhesive 228 or biological agents are delivered to abioreactive adhesive 228. - As described above with respect to
FIG. 5 for theclosure device 104, theclosure device 204 may similarly further include aremovable divider 244 having aprimer 256 coated on itssecond surface 252. As illustrated inFIG. 6 , theremovable divider 244 separates the adhesive 228 from theprimer 256. -
FIG. 7 depicts aclosure device 304, capable of being used for the percutaneous transluminal closure of a patent foramen ovale, according to another illustrative embodiment of the invention. As illustrated, theexemplary closure device 304 includes aU-shaped patch 324 and an adhesive 328. In one embodiment, theU-shaped patch 324 includes anouter surface 306 and aninner surface 310 to which the adhesive 328 is coated. The U-shaped patch is specifically configured for attachment to aseptum secundum 36 of a patent foramen ovale. - The
U-shaped patch 324 may be made from the biological materials, the bioresorbable materials, the synthetic materials, the polymeric materials, the shape memory materials, and/or the metal meshes described above, or from other suitable materials for closing a patent foramen ovale, such as combinations of these materials. For its part, the adhesive 328 may be, for example, a cyanoacrylate, a fibrin based adhesive, and/or a light activated adhesive. - In one embodiment, the
U-shaped patch 324 further includes on itsouter surface 306, i.e., convex surface, and/or on itsinner surface 310, i.e., concave surface, a substance that stimulates in-growth of the patient's tissue into the patent foramen ovale following placement of theclosure device 304 on theseptum secundum 36 of the patent foramen ovale. In one embodiment, the growth substance is, for example, a growth factor, such as a vascular endothelial growth factor, a basic fibro growth factor, or an angiogenic growth factor. In another embodiment, the growth substance is a pharmacological agent for stimulating tissue growth, such as, for example, growth of cells or expression of genes. Alternatively, in another embodiment, the growth substance is a topical irritant for encouraging an inflammatory response, such as, for example, cotton seed oil or alcohol. - In one embodiment, because the
closure device 304 is placed on theseptum secundum 36, the growth substance is delivered to, or impregnated within, theseptum secundum 36 and the tissue in-growth into the patent foramen ovale therefore occurs from theseptum secundum 36. In another embodiment, the natural hydraulic pressure difference between theright atrium 26 and theleft atrium 32 eventually causes the septum primum 40 to contact theclosure device 304 that has been coupled to theseptum secundum 36. In such a case, the growth substance coated on theouter surface 306 of theclosure device 304 would contact the septum primum 40 and be delivered to, or impregnated within, theseptum primum 40. Tissue in-growth into the patent foramen ovale would therefore occur from theseptum primum 40. The newly grown tissue leads to the closure of the patent foramen ovale. - In yet another embodiment, a substance for increasing endothelization, or, alternatively, a substance for decreasing thrombogenicity, such as, for example, heparin, is coated on the
outer surface 306 and/or on theinner surface 310 of theU-shaped patch 324. -
FIGS. 8 , 9, and 10 depict, according to further illustrative embodiments of the invention, theexemplary closure device 304 ofFIG. 7 coupled to theseptum secundum 36 of a patent foramen ovale. As shown in each ofFIGS. 8 , 9, and 10, theclosure device 304 may further include at least one barrier 314 coupled to theU-shaped patch 324. For example, theclosure device 304 may include a right atrial barrier 314A, as shown inFIG. 8 , for blocking an opening to the patent foramen ovale from theright atrium 26, a left atrial barrier 314B, as shown inFIG. 9 , for blocking an opening to the patent foramen ovale from theleft atrium 32, or, alternatively, both a right atrial barrier 314A and a left atrial barrier 314B, as shown inFIG. 10 . In one embodiment, the right atrial barrier 314A and/or the left atrial barrier 314B include(s) an adhesive for bonding the barrier 314 to theseptum primum 40, as shown. In another embodiment, the right atrial barrier 314A and/or the left atrial barrier 314B include(s), as described above for theU-shaped patch 324, a substance that stimulates tissue in-growth into theclosure device 304 following placement of theclosure device 304 on theseptum secundum 36 of the patent foramen ovale. - In another aspect, the invention provides methods for percutaneously closing a cardiac opening in a patient.
FIGS. 11A-11C depict the steps of an illustrative method for closing a cardiac opening in a patient using theclosure device 104 of the invention. Similar steps, with appropriate differences described below, are also performed in closing a cardiac opening in a patient using theclosure device 204 of the invention. The cardiac opening illustrated inFIGS. 11A-11C is a patent foramen ovale. However, as described below, the methods of the invention may also be used to close or obliterate a left atrial appendage. - Referring to
FIG. 11A , in one embodiment, an operator such as a physician advances asheath 400 into the patient's heart and positions adistal end 404 of thesheath 400 proximate the cardiac opening. The physician then advances the system. 100, including theclosure device 104 and thedelivery catheter 108, into and through alumen 408 of thesheath 400. The physician continues to advance thesystem 100 though thelumen 408 of thesheath 400 until theclosure device 104 exits thedistal end 404 of thesheath 400 and expands to a position proximate the cardiac opening, as illustrated inFIG. 11B . Theclosure device 104 may be made to expand by any of a variety of means. For example, theshape memory frame 110 described above may cause theclosure device 104 to expand. Alternatively, thepatch 124 of theclosure 104 may itself be made from a shape memory material, such as a shape memory alloy. - Where the
closure device 104 includes both the adhesive 128 and theremovable divider 144 containing the primer 156 (seeFIG. 5 ), in order to couple theclosure device 104 to a tissue surface of the patient proximate the cardiac opening, the physician first applies theprimer 156 to the tissue surface. In one embodiment, the physician advances theclosure device 104 distally to contact the patient's tissue surface with theprimer 156 contained on thesecond surface 152 of theremovable divider 144. The physician then withdraws theclosure device 104 proximally to separate it from the patient's tissues and removes theremovable divider 144 from about the rest of theclosure device 104. - After applying the
primer 156 to the patient's tissues proximate the cardiac opening and removing theremovable divider 144, the physician advances theclosure device 104 to contact the patient's tissue proximate the cardiac opening with thedistal side 132 of thepatch 124. In one embodiment, the adhesive 128 is coated on the surface of thedistal side 132 ofpatch 124 and is therefore immediately applied to the patient's tissues. In another embodiment, after contacting the patient's tissues with thedistal side 132 of thepatch 124, the physician injects the adhesive 128 through thelumen 120, through thehollow channels 136, and throughholes 137 on thedistal side 132 of thepatch 124 to apply the adhesive 128 to the patient's tissue. - With the adhesive 128 of the
closure device 104 in contact with the patient's tissues proximate the cardiac opening, the physician activates the adhesive 128 to cure the adhesive 128 to the patient's tissues. Specifically, for a light activated adhesive 128, the physician provides light to thehollow channels 136 enclosed within thepatch 124, thereby activating the adhesive 128. In another embodiment, where the physician uses theclosure device 204 to close the cardiac opening (seeFIG. 6 ), the physician causes thelight source 236 enclosed within thehousing 222 of theclosure device 204 to emit light. Thehousing 222 prevents the blood in the area surrounding theclosure device 204 from blocking, or otherwise interfering with, the passage of emitted light. Thehousing 222 therefore ensures that the emitted light reaches the adhesive 228 to activate the adhesive 228. - Once the adhesive 128 has cured to the patient's tissue proximate the cardiac opening, the physician separates the
patch 124 of theclosure device 104 from thedelivery catheter 108 of thesystem 100, or, alternatively, separates thereleasable patch 224 of theclosure device 204 from thehousing 222 of theclosure device 204. For example, the physician causes thepatch 124 or thereleasable patch 224 to break away from thedelivery catheter 108 or thehousing 222, respectively, by applying a torque. Alternatively, a variety of other mechanical means may be used to separate thepatch 124 from thedelivery catheter 108 or thereleasable patch 224 from thehousing 222. Accordingly, thepatch 124 of theclosure device 104, or thereleasable patch 224 of theclosure device 204, is positioned across the cardiac opening to substantially occlude the cardiac opening For instance, as illustrated inFIG. 11C , thepatch 124 is positioned across a patent foramen ovale. In another embodiment, steps similar to those described above are performed to position the patch across a leftatrial appendage 80, as illustrated inFIG. 11D . - Alternatively, in another embodiment, as described above, the
hollow channels 136 of thepatch 124 of theclosure device 104 enclose theframe 110, but theclosure device 104 does not also include the adhesive 128 or theremovable divider 144 containing theprimer 156. In such an embodiment, following the exit, and the expansion, of theclosure device 104 from thedistal end 404 of thesheath 400, as illustrated inFIG. 11B , the physician contacts the patient's tissues proximate the cardiac opening with thepatch 124 of theclosure device 104 and thermally welds thepatch 124 to the patient's tissues. More specifically, in one embodiment, the physician generates a radio frequency current through theframe 110 enclosed within thehollow channels 136 of thepatch 124. The resultant radio frequency energy applied to the patient's tissues proximate the cardiac opening, and to thepatch 124 itself, heats the patient's tissues and the biological material from which thepatch 124 is made. By applying this heat, and by also pressing thepatch 124 against the patient's tissues proximate the cardiac opening, the physician fuses thepatch 124 to the patient's tissues. Accordingly, thepatch 124 of theclosure device 104 is positioned across the cardiac opening to substantially occlude the cardiac opening. In one embodiment, the physician then retracts theframe 110 from within thepatch 124 and removes theframe 110, along with thesheath 400 and thedelivery catheter 108, from the patient's body. - In accordance with the methods described above, where the cardiac opening under repair is a patent foramen ovale, the
closure device 104 may be deployed in theright atrium 26, as illustrated inFIG. 11B , and thepatch 124 may be bonded to the right atrial walls of the septum primum 40 and theseptum secundum 36, as illustrated inFIG. 11C . Alternatively, in another embodiment in accordance with the methods described above, thesheath 400 is advanced through the patent foramen ovale and theclosure device 104 is deployed in theleft atrium 32, as illustrated inFIG. 11E . In such an embodiment, by proximally withdrawing theclosure device 104 to contact the left atrial walls of the septum primum 40 and theseptum secundum 36, thepatch 124 may be bonded thereto, as illustrated inFIG. 11F , in any of the manners described above. - Alternatively, in yet another embodiment, to substantially occlude a cardiac opening or to obliterate a left atrial appendage, the physician places the
patch 124 within the cardiac opening or the left atrial appendage, and bonds it thereto. - To percutaneously close a patent foramen ovale using the
closure device 304 of the invention, the physician first performs essentially the same steps as illustrated and described above with respect toFIGS. 11A and 11B . More specifically, in one embodiment, the physician positions thedistal end 404 of thesheath 400 proximate the patent foramen ovale and advances theclosure device 304, by means of a delivery catheter attached to theclosure device 304, into and through thelumen 408 of thesheath 400 until theclosure device 304 exits thedistal end 404 of thesheath 400 and expands to a position proximate the patent foramen ovale. - Because the
septum secundum 36 is rather thick in comparison to theseptum primum 40, the physician then couples theinner surface 310 of theclosure device 304, which contains the adhesive 328, to theseptum secundum 36. Once the adhesive 328 has cured and glued to theseptum secundum 36, the physician removes the delivery catheter from about theU-shaped patch 324 of theclosure device 304, leaving theclosure device 304 attached to the patient'sseptum secundum 36, as illustrated inFIG. 12 . - As described above, the
U-shaped patch 324 may include a substance that stimulates in-growth of the patient's tissue into theclosure device 304 from either theseptum secundum 36, theseptum primum 40, or both theseptum secundum 36 and the septum primum 40 Following placement of theclosure device 304 on theseptum secundum 36, as illustrated inFIG. 12 , this tissue in-growth may be relied upon to substantially occlude the patent foramen ovale. Alternatively, as illustrated inFIGS. 8 , 9, and 10, theclosure device 304 may be further provided with either a right atrial bather 314A, a left atrial barrier 314B, or both the right atrial barrier 314A and the left atrial barrier 314B to assist in closing the patent foramen ovale. The barriers 314A, 314B may include adhesives and may be bonded to theseptum primum 40, as shown. Moreover, the barriers 314A, 314B may include substances that stimulate tissue in-growth into theclosure device 304 from either theseptum secundum 36, theseptum primum 40, or both theseptum secundum 36 and theseptum primum 40. - In yet another aspect, the invention provides a compound for percutaneous transluminal closure of a cardiac opening, such as a patent foramen ovale, or for percutaneous transluminal obliteration of a cardiac cul-de-sac, such as a left atrial appendage. In one embodiment, the compound is used alone to close the cardiac opening or to obliterate the cardiac cul-de-sac. In another embodiment, the compound is used together with a
closure device -
FIG. 13 depicts anexemplary compound 500 in accordance with this aspect of the invention. As illustrated, thecompound 500 includes an adhesive 504 and a plurality ofcomposite particles 508 disposed within the adhesive 504. In one embodiment, the plurality ofcomposite particles 508 are capable of expansion upon contact with blood and/or water. Thecomposite particles 508 are, for example, gelatin particles, biological particles, bioresorbable particles, and/or foam particles that swell upon contact with blood and/or water. In one embodiment, the adhesive 504 is a fibrin based adhesive. Alternatively, in other embodiments, thecompound 500 includes other types ofadhesives 504. Moreover, the adhesive 504 may be a permanent adhesive in the sense that, following placement of the adhesive 504 into the cardiac opening, the adhesive 504 permanently remains in the cardiac opening over time. Alternatively, in another embodiment, the adhesive 504 is a temporary adhesive that gradually disappears over time after having been placed in the cardiac opening. Mixed into the adhesive 504 may be a substance that promotes tissue in-growth into the cardiac opening over time. - In one embodiment, a physician positions the distal end of the sheath proximate the cardiac opening. The physician then advances, for example, a delivery catheter containing the
compound 500 through a lumen of the sheath, until the delivery catheter exits the distal end of the sheath to he within the cardiac opening. The physician then injects thecompound 500 into the cardiac opening. Once injected into the cardiac opening and upon contact with the surrounding blood and/or water, the plurality ofcomposite particles 508 disposed within the adhesive 504 of thecompound 500 expand. By expanding, the plurality ofcomposite particles 508 help to lock the adhesive 504 into place and to prevent the adhesive 504 from being washed away by the surrounding blood. More specifically, upon being injected into the cardiac opening, the adhesive 504 of thecompound 500 cures both to the patient's surrounding tissue and to the plurality of expandingcomposite particles 508. As a result, thecompound 500 substantially occludes the cardiac opening such as a patent foramen ovale. Similar steps may be performed to substantially obliterate an intra-cardiac cul-de-sac, such as the left atrial appendage. - In addition to closing the cardiac opening or obliterating the cardiac cul-de-sac on its own, the
compound 500 may also be used in conjunction with theclosure devices compound 500 is injected into a patent foramen ovale or a left atrial appendage, or as thecompound 500 is being injected, thepatch 124 of theclosure device 104 or thereleasable patch 224 of theclosure device 204 may be positioned across the cardiac opening, for example the patent foramen ovale or across the intra-cardiac cul-de-sac such as the left atrial appendage and coupled to the proximate tissue surface. Alternatively, prior to injecting thecompound 500 into a patent foramen ovale, theclosure device 304, including either or both the right atrial barrier 314A and the left atrial barrier 314B, described above, maybe bonded to theseptum secundum 36, as described above. The above-describedpatch 124 of theclosure device 104, thereleasable patch 224 of theclosure device 204, and/or the atrial barriers 314A, 314B of theclosure device 304 can thus be used to ensure that the adhesive 504 of thecompound 500 remains in the cardiac opening and can also be used to aid thecompound 500 in occluding the cardiac opening or the cardiac cul-de-sac, or in obliterating the cardiac cul-de-sac. - Referring now to embodiments of closure devices that include a balloon,
FIG. 14 depicts an exemplary percutaneoustransluminal system 600 for positioning aballoon 700 in, for example, thepatent foramen ovale 44 or the leftatrial appendage 80 described above. In one embodiment theclosure system 600 includes theballoon 700 coupled to aballoon catheter 612. In accordance with the invention, either an adhesive, a substance for stimulating tissue growth, or both an adhesive and a substance for stimulating tissue growth is coated on, or contained within, theballoon 700. In use, theballoon 700 may be placed within a cardiac opening, such as a patent foramen ovale of the patient. Once placed within the cardiac opening, theballoon 700 may be manipulated to deliver the adhesive and/or the substance for stimulating tissue growth to the tissue surface of the cardiac opening. In one embodiment, theballoon 700 is then released from theballoon catheter 612 and left behind in the cardiac opening, while theballoon catheter 612 is removed from the patient. In such a case, theballoon 700 assists in closing the cardiac opening. Similar steps may be performed to close a cardiac cul-de-sec. Alternatively, in another embodiment, theballoon 700 is, after having delivered the adhesive and/or the substance for stimulating tissue growth to the tissue surface of a cardiac opening, removed from the cardiac opening and withdrawn from the patient along with theballoon catheter 612. In this case, the cardiac opening is encouraged to heal itself. - Referring briefly to
FIGS. 15-17 , to help locate a cardiac opening and properly position theballoon 700 within the cardiac opening, theclosure system 600 includes, in some embodiments, a proximal locator 628 (i.e., a locator that is closest to a physician when the physician is using the closure system 600), an opposite,distal locator 630, or both theproximal locator 628 and thedistal locator 630. In use, thelocator 628 locates a proximal end of a cardiac opening. Thelocator 630 locates a distal end of the cardiac opening. - Referring again to
FIG. 14 , theballoon 700 includes aproximal end 614 and an opposite,distal end 616. In one embodiment, theballoon 700 also includes aproximal opening 633 at itsproximal end 614, adistal opening 635 at itsdistal end 616, and alumen 631 extending from itsproximal end 614 to itsdistal end 616. For its part, theballoon catheter 612 includes aproximal end 618, an opposite,distal end 620, and alumen 619 extending from theproximal end 618 to thedistal end 620. In the illustrative embodiment shown, theballoon catheter 612 extends through theproximal opening 633, through thelumen 631, and through thedistal opening 635 of theballoon 700 so that theentire balloon 700 is located between theproximal end 618 and thedistal end 620 of theballoon catheter 612. In such an embodiment, the portion ofballoon catheter 612 located within theballoon 700 includes a plurality ofholes 611. Accordingly, thelumen 619 of theballoon catheter 612 is in fluid communication with thelumen 631 of theballoon 700. In another embodiment, thedistal end 620 of theballoon catheter 612 is coupled to theproximal end 614 of theballoon 700 such that thelumen 619 of theballoon catheter 612 is contiguous with thelumen 631 of theballoon 700. Alternatively, in yet another embodiment, thedistal end 620 of theballoon catheter 612 extends through theproximal opening 633 and is located within thelumen 631 of theballoon 700. - In one embodiment, the
balloon 700 is releasably coupled to theballoon catheter 612. For example, theballoon 700 is coupled to theballoon catheter 612 so that it may be separated from theballoon catheter 612 by applying a force, such as compression, tension, torsion, or any other type of force. In this embodiment, theballoon 700 is left within the cardiac opening to assist in closing the cardiac opening. In another embodiment, theballoon 700 is permanently coupled to theballoon catheter 612 for removal from the patient's body along withballoon catheter 612. -
FIG. 14 also depicts adelivery catheter 622 having alumen 624. In one embodiment, to deliver theballoon 700 to a cardiac opening in a patient, the physician first places adistal end 626 of thedelivery catheter 622 in the patient's heart proximate the cardiac opening. The physician then places theclosure system 600 in thelumen 624 of thedelivery catheter 622 and advances theclosure system 600 through thelumen 624 of thedelivery catheter 622 until theclosure system 600 exits thedistal end 626 of thedelivery catheter 622, as shown. Methods of delivering theballoon 700 to the patient are described further below. -
FIGS. 15-17 depict the percutaneoustransluminal closure system 600 for positioning theballoon 700 in a cardiac opening of a patient according to alternative illustrative embodiments of the invention. As depicted inFIG. 15 , theclosure system 600 includes, in one embodiment, an expandableproximal locator 628 for locating a proximal end of a cardiac opening. Thelocator 628 may be, as shown, coupled to theballoon catheter 612, to theproximal end 614 of theballoon 700, or to both theballoon catheter 612 and theballoon 700. In one embodiment, thelocator 628 is a right atrial locator for locating apatent foramen ovale 44 from theright atrium 26. When expanded, thelocator 628 is configured to abut the tissue surfaces of theseptum secundum 36 and the septum primum 30 from theright atrium 26 as theballoon 700 is placed within thepatent foramen ovale 44. Accordingly, thelocator 628 locates thepatent foramen ovale 44. In another embodiment, thelocator 628 is used for locating an exterior tissue surface of a leftatrial appendage 80. In this case, thelocator 628 is configured to abut the exterior tissue surface of the leftatrial appendage 80 as theballoon 700 is placed within the leftatrial appendage 80. - In another embodiment, as depicted in
FIG. 16 , theclosure system 600 includes an expandabledistal locator 630 for locating a distal end of a cardiac opening. More specifically, thelocator 630 is a left atrial locator for locating apatent foramen ovale 44 from theleft atrium 32. Thelocator 630 may be, as shown, coupled to theballoon catheter 612, to thedistal end 616 of theballoon 700, or to both theballoon catheter 612 and theballoon 700. In use, a physician advances theballoon 700 from theright atrium 26, through thepatent foramen ovale 44, to theleft atrium 32. The physician then expands thelocator 630 in theleft atrium 32 and withdraws theballoon 700 from theleft atrium 32 back into thepatent foramen ovale 44. Thelocator 630 is configured to abut the tissue surfaces of theseptum secundum 36 and the septum primum 40 from theleft atrium 32 as theballoon 700 is placed within thepatent foramen ovale 44. Accordingly, thelocator 630 locates thepatent foramen ovale 44 and properly positions theballoon 700 within thepatent foramen ovale 44. - In yet another embodiment, and with reference now to
FIG. 17 , theclosure system 600 includes two locators, aproximal locator 628 and adistal locator 630. - The
locators locators locators locators locators - A plurality of arms, as illustrated for the
proximal locator 628 inFIG. 15 , may form thelocators locators distal locator 630 inFIG. 16 , as a balloon, as illustrated for thedistal locator 630 inFIG. 17 , or as a rod, as illustrated for theproximal locator 628 inFIG. 17 . Any other geometry deemed suitable by one skilled in the art, such as, for example, a spiral wire, may also be used for thelocators locators balloon 700 and/or to theballoon catheter 612. For example, thelocators balloon 700 and/or to theballoon catheter 612 so that they may he separated from theballoon 700 and/or theballoon catheter 612 by applying a force, such as compression, tension, torsion, or any other type of force. In another embodiment, thelocators balloon 700 and/or to theballoon catheter 612 for removal from the patient's body along with theballoon 700 and/or theballoon catheter 612. - In another embodiment, an adhesive 632 is coated on the
locators locators septum secundum 36 and/or to the wall of the septum primum 40 when theballoon 700 is used to close apatent foramen ovale 44. Alternatively, the adhesive 632 may be used to bond theproximal locator 628 to a tissue surface proximate a leftatrial appendage 80 when theballoon 700 is used to obliterate the leftatrial appendage 80. The adhesive 632 may be, for example, a cyanoacrylate, a fibrin based adhesive, or an albumin gluteraldehyde type adhesive. -
FIG. 18 depicts an inflated balloon, generally 700, having anouter surface 648. In one embodiment, an adhesive 656 is coated on theouter surface 648 of theballoon 700 a.FIG. 19 depicts theballoon 700 a deflated or partially deflated andFIG. 20 depicts a schematic cross-sectional view of theballoon 700 a ofFIG. 19 taken along the line 19-19. Typically, theballoon 700 a of the invention is coupled to theballoon catheter 612, as described previously, and is initially delivered to a cardiac opening in a heart of a patient with theballoon 700 a deflated or partially deflated. - Referring to
FIG. 20 , theouter surface 648 of the deflated or partially deflatedballoon 700 a is involuted to form acavity 660 around the circumference of theouter surface 648 of theballoon 700 a. In one embodiment, themidline 676 of theouter surface 648 of theballoon 700 a is pushed towards the inside of theballoon 700 a to form thecavity 660. Theedges cavity 660 are folded to contact or overlap one another, as illustrated. By folding theballoon 700 a as such, theouter surface 648 of theballoon 700 a seals thecavity 660 from exposure to anoutside environment 684. - In one embodiment, adhesive 656 is coated on the surface of the
cavity 660 of the deflated or partially deflatedballoon 700 a. Accordingly, when theballoon 700 a is deflated or partially deflated, the adhesive 656 is also sealed from exposure to theoutside environment 684. By delivering theballoon 700 a to the patient's cardiac opening with theballoon 700 a deflated, the adhesive 656 is not exposed to the patient's blood and, according to one advantage of the invention, the risk of thrombus formation is thereby minimized. Once properly positioned within a patient's cardiac opening, theballoon 700 a may be inflated, thereby causing theinvoluted cavity 660 to unfold, as illustrated inFIG. 21 , and exposing the adhesive 656 to the patient's tissues within the cardiac opening. Although thecavity 660 has been shown encircling the mid-portion of theballoon 700 a, thecavity 660 may encircle in any orientation any portion of theouter surface 648 of theballoon 700 a and in fact may be restricted to being simply an involuted pocket in a portion of theouter surface 648 of theballoon 700 a, as illustrated inFIG. 22 . -
FIG. 23 depicts an embodiment of aballoon 700 b. Theballoon 700 b has anouter surface 748. An expandable porous band 752 (e.g., an elastic band 752), having a plurality ofopenings 756, encircles, in one embodiment, only a portion of theouter surface 748 of theballoon 700 b, such as thecenter portion 728 of theballoon 700 b. In alternative embodiments, the expandableporous band 752 encircles other portions of theballoon 700 b. In one embodiment, an adhesive 716 is disposed between theouter surface 748 of theballoon 700 b and the expandableporous band 752. The expandableporous band 752 is designed such that, until theballoon 700 b is sufficiently inflated, theopenings 756 of theporous band 752 are too small to allow any of the adhesive 716 to pass therethrough. By ensuring that theballoon 700 b is not sufficiently inflated, a physician can prevent the adhesive 716 from being inadvertently exposed to a patient's blood and can thereby avoid thrombus formation. -
FIG. 24 depicts a schematic cross-sectional view of theballoon 700 b ofFIG. 23 taken along the line 23-23. When nearly sufficiently inflated, across-sectional diameter 760 of thecenter portion 728 of theballoon 700 b is, in one embodiment, slightly less than the inner circumference of the cardiac opening or the cardiac cul-de-sac that theballoon 700 b is to close. For example, where theballoon 700 b is used to close apatent foramen ovale 44, thecenter portion 728 of theballoon 700 b is designed to have, when nearly sufficiently inflated, across-sectional diameter 760 between approximately 1 millimeter and approximately 25 millimeters. Alternatively, when theballoon 700 b is used to close a leftatrial appendage 80, thecenter portion 728 of theballoon 700 b is designed to have, when nearly sufficiently inflated, across-sectional diameter 760 between approximately 5 millimeters and approximately 25 millimeters. -
FIG. 25 depicts another embodiment of aballoon 700 c. Contained within thelumen 862 of theballoon 700 c is an adhesive 816. Theballoon 700 c has a plurality ofholes 864. In various embodiments, theholes 864 are pores or slits. Until sufficiently inflated, theballoon 700 c will not have expanded and/or stretched to a point where theholes 864 are large enough to allow the adhesive 816 to pass therethrough. -
FIG. 26 depicts yet another illustrative embodiment of the invention. This embodiment includes two concentric balloons 700 dA, 700 dB and an adhesive 916 located within the lumen 962B of theinner balloon 700 dB. In one embodiment, the outer balloon 700 dA and the inner balloon 700 dB each include a plurality of holes (e.g., pores or slits) 964A and 964B, respectively. - Once the
balloon 700 b, c, or d is placed within the cardiac opening or the cardiac cul-de-sac of a patient and is nearly sufficiently inflated, the further application of pressure to theballoon 700 b, c, or d enlarges theopenings 756 of theporous band 752, theholes 864, or the holes 964, respectively. The adhesive is thereby forced through theopenings 756, theholes 864, or the holes 964 to the tissue surface of the cardiac opening or the cardiac cul-de-sac. A physician may apply the further pressure to theballoon 700 b, c, or d by further inflating the lumen of theballoon 700 b, c, or d. For example, to further inflate thelumen 862 of theballoon 700 c, the physician pumps additional adhesive 816 through thelumen 619 of theballoon catheter 612 into thelumen 862 of theballoon 700 c. Alternatively, compression of a part of theballoon 700 b, c, or d by, for example, contacting the tissue surface of the cardiac opening or the cardiac cul-de-sac with that part of theballoon 700 b, c, or d, thus further inflating the remaining portions of theballoon 700 b, c, or d, will also cause the adhesive to be exposed to the tissue surface. In certain embodiments, the adhesive is only exposed to the patient's tissues in the area where theballoon 700 b, c, or d contacts the patient's tissues. For example, in one embodiment, the adhesive is only exposed in the area where the patient's tissues compress theballoon 700 b, c, or d. -
FIG. 27 depicts aballoon 700 e having amembrane 1088 constructed from a wicking material. The wicking material may be, for example, a natural fiber, such as cotton. In one embodiment, an adhesive 1016 is absorbed within the wicking material of theballoon membrane 1088. The adhesive 1016 is naturally drawn, by capillary action, to theouter surface 1008 of theballoon 700 e. Additionally, as shown, the adhesive 1016 may also be contained within alumen 1062 of theballoon 700 e. - Once the
balloon 700 e is placed within, for example, the cardiac opening, contacting the tissue surface of the cardiac opening with themembrane 1088 of theballoon 700 e draws, by capillary action, further adhesive 1016 absorbed within themembrane 1088 to theouter surface 1008 of theballoon 700 e. The tissue surface of the cardiac opening is thereby coated with the adhesive 1016. -
FIG. 28 depicts still another embodiment of the invention. As shown, aballoon 700 f has a first adhesive 1116A coated on anouter surface 1108 of theballoon 700 f. Alight source 1168 is located within thelumen 619 of theballoon catheter 612 and within a lumen of theballoon 700 f. Theballoon catheter 612 may be translucent, or, alternatively, may includes holes in the region of the,light source 1168, to allow the light emitted by thelight source 1168 to propagate outside theballoon catheter 612. Thelight source 1168 is, in one embodiment, a light bulb coupled through theballoon catheter 612 to a power supply. In another embodiment, thelight source 1168 is an optical fiber connected at its other end to a source of illumination. - In yet another embodiment, a second adhesive 1116B is coated on an
inner surface 1112 of theballoon 700 f. The first adhesive 1116A and/or the second adhesive 1116B may each be, for example, a light activated adhesive, such as an adhesive curable with ultraviolet light. The first adhesive 1116A and the second adhesive 1116B may cover only a portion of theouter surface 1108 of theballoon 700 f and theinner surface 1112 of theballoon 700 f, respectively, as shown, or they may cover the entireouter surface 1108 and inner surface, respectively. In one embodiment, theballoon 700 f is translucent. -
FIG. 29 depicts a schematic cross-sectional view of theballoon 700 f ofFIG. 28 , taken along the line 28-28. As shown inFIGS. 28 and 29 , theballoon 700 f further includes, in one embodiment, a first non-reactiveremovable divider 1172. Thedivider 1172 is coupled to theballoon 700 f so that onesurface 1176 of thedivider 1172 contacts the first adhesive 1116A coated on theouter surface 1108 of theballoon 700 f. Coated on thesecond surface 1108 of thedivider 1172 is aprimer 1184. In one embodiment, theprimer 1184 prepares the tissue surface of the patient to which the adhesive 1116A will be applied. In another embodiment, theprimer 1184 helps to activate the adhesive 1116A and/or bond the adhesive 1116A to the patient's tissue surface. - In another embodiment, a second removable divider or temporary membrane (not shown) covers the
primer 1184 to protect it against premature exposure to blood. The second removable divider or temporary membrane may have attached to it sutures that can be pulled upon by the physician to remove it from theprimer 1184 when the physician is ready to apply theprimer 1184 to the tissues of the patient's cardiac opening. Similarly, in one embodiment, the firstremovable divider 1172 has attached to it sutures that can be pulled upon by the physician to remove it from the adhesive 1116A when the physician is ready to apply the adhesive 1116A to the tissues of the patient's cardiac opening. - The
balloons 700 described above may be tubularly-shaped. In alternative embodiments, theballoons 700 have other shapes, such as, for example, circular or rectangular shapes. The adhesives- coated on, or contained within, theballoons 700 of the invention may be, for example, cyanoacrylates, fibrin based adhesives, albumin gluteraldehyde type adhesives, or light activated adhesives. Alternatively, other adhesives, known to those skilled in the art, may be used. - In some embodiments, the
balloons 700 include a substance for stimulating tissue growth. The growth substance may be combined with the adhesives of theballoons 700 or be used independently. In fact, the growth substance may be applied to, or be positioned within, theballoons 700 in the same manner as described above for the adhesives of theballoons 700. In one embodiment, the growth substance is, for example, a growth factor, such as a vascular endothelial growth factor, a basic fibro growth factor, or an angiogenic growth factor. In another embodiment, the growth substance is a pharmacological agent for stimulating tissue growth, such as, for example, cells or genes. Alternatively, in another embodiment, the growth substance is an irritant for encouraging an inflammatory response, such as, for example, cotton seed oil or alcohol. - The
balloons 700 a, b, c, d, and f described above are, in one embodiment, made from an elastomer material, such as, for example, a polylurethane or a silicone. In another embodiment, theballoons 700 a, b, c, d, and f are made from a biological material, such as, for example, a collagen or a bioresorbable polymer. Alternatively, theballoons 700 a, b, c, d, and f are made from other materials. -
FIG. 30 depicts aclosure system 600 according to still another illustrative embodiment of the invention. As illustrated, theexemplary closure system 600 includes thedelivery catheter 622 described above, asock catheter 612′, and a sock-shapedlining 634. For its part, the lining 634 has anopen end 636, aclosed end 637, afirst surface 638, and asecond surface 629. In one embodiment, theopen end 636 of the lining 634 is coupled to thedistal end 626 of thedelivery catheter 622 and theclosed end 637 of the lining 634 is coupled to thedistal end 620 of thesock catheter 612′. When thesock catheter 612′ is retracted, as depicted inFIG. 30 , the lining 634 is contained within thelumen 624 of thedelivery catheter 622, thefirst surface 638 forms an inner surface of the sock-shapedlining 634, and thesecond surface 629 forms an outer surface of the sock-shapedlining 634. When thesock catheter 612′ is deployed, as illustrated inFIG. 31 , the lining 634 inverts. Consequently, thefirst surface 638 now forms an outer surface of the sock-shapedlining 634 and thesecond surface 629 forms an inner surface of the sock-shapedlining 634. - In the illustrative embodiment shown in
FIGS. 30 and 31 , an adhesive 639, similar to any of the adhesives used for theballoons 700 described above, is coated on thefirst surface 638 of thelining 634. Typically, a physician advances theclosure system 600 with thesock catheter 612′ retracted, as illustrated inFIG. 30 , and, once theclosure system 600 is proximate a cardiac opening, the physician deploys thesock catheter 612′ so that it exits thedistal end 626 of thedelivery catheter 622, as illustrated inFIG. 31 . In one embodiment, the physician deploys thesock catheter 612′ by advancing (e.g., pushing) it distally or by withdrawing (e.g., pulling) thedelivery catheter 622 proximally. Alternatively, in another embodiment, thesock catheter 612′ is itself a balloon that may be expanded to exit thedistal end 626 of thedelivery catheter 622. By deploying thesock catheter 612′, the lining 634 inverts to expose thefirst surface 638 and the adhesive 639 coated thereon to the patient's tissues. - In another embodiment, the lining 634 includes a plurality of holes (not shown). In one such embodiment, the adhesive 639 is coated on the
second surface 629 of thelining 634 and/or is contained (e.g., absorbed) within the lining 634 itself. By deploying thesock catheter 612′ as shown inFIG. 21 , the lining 634 inverts and stretches, thereby enlarging the plurality of holes. Accordingly, the adhesive 639 may pass through the plurality of holes to thefirst surface 638 of the lining 634 for application to the patient's tissues. - In yet another embodiment, a substance for stimulating tissue growth, as described above, is combined with the adhesive 639 or is used independently.
- In another aspect, the invention features methods for delivering a
balloon 700 to a cardiac opening or a cardiac cul-de-sac in a patient and also methods for percutaneously closing the cardiac opening or obliterating the cardiac cul-de-sac using the deliveredballoon 700.FIGS. 32A-32D depict the steps of an illustrative method for delivering aballoon 700 of the invention to a cardiac opening in a patient. The cardiac opening illustrated inFIGS. 32A-32D is apatent foramen ovale 44. However, as described below, the methods of the invention may also be used to obliterate a leftatrial appendage 80. - Referring to
FIG. 32A , in one embodiment, a physician advances thedelivery catheter 622 into the patient's heart and positions thedistal end 626 of thedelivery catheter 622 proximate the cardiac opening. The physician then advances theballoon 700 and theballoon catheter 612 into and through thelumen 624 of thedelivery catheter 622. The physician continues to advance theballoon 700 until it and a distal portion of theballoon catheter 612 exit thedistal end 626 of thedelivery catheter 622 adjacent the cardiac opening, as illustrated inFIG. 32B . In one embodiment, a deflatedballoon 700 exits thedistal end 626 of thedelivery catheter 622 and is kept deflated until appropriately positioned within the cardiac opening. Theballoon 700 is then inflated. In another embodiment, the balloon 700 (e.g., theballoon 700 f depicted inFIGS. 28 and 29 ) exits thedistal end 626 of thedelivery catheter 622 inflated, or, alternatively, exits deflated and is inflated by the physician prior to being positioned within the cardiac opening. - Referring now to
FIG. 32C , after theballoon 700 exits thedistal end 626 of thedelivery catheter 622 and/or is inflated adjacent the cardiac opening by the physician, the physician, in one embodiment, expands theproximal locator 628 adjacent the cardiac opening. In one embodiment, with thelocator 628 expanded as illustrated inFIG. 32C , the physician advances theballoon 700 into the cardiac opening. The physician continues to advance theballoon 700 into the cardiac opening until thelocator 628 abuts a tissue surface proximate cardiac opening. For example, as depicted inFIG. 32D , the physician advances theballoon 700 into thepatent foramen ovale 44 until thelocator 628 abuts the proximal walls of theseptum secundum 36 and theseptum primum 40. Alternatively, where the leftatrial appendage 80 is to be obliterated, the physician advances theballoon 700 into the leftatrial appendage 80 until thelocator 628 abuts the tissue surface of the heart proximate the leftatrial appendage 80. Having used thelocator 628 to locate the cardiac opening, the physician then uses thelocator 628 to correctly position theballoon 700 within the cardiac opening In one embodiment, theballoon 700 is correctly positioned within the cardiac opening when thelocator 628 abuts the tissue surface proximate the cardiac opening. In another embodiment, the physician proximally withdraws thelocator 628 by a fixed amount from the tissue surface of the cardiac opening to correctly position theballoon 700 within the cardiac opening. - The methods described above for positioning the
balloon 700 within a cardiac opening apply equally to positioning theballoon 700 within apatent foramen ovale 44 or a leftatrial appendage 80. Alternatively, other illustrative methods, specific to positioning aballoon 700 within apatent foramen ovale 44, are illustrated inFIGS. 33A-33E . - Referring first to
FIG. 33A , in one embodiment, the physician advances thedelivery catheter 622 into the patient's heart and through thepatent foramen ovale 44, thereby positioning thedistal end 626 of thedelivery catheter 622 in theleft atrium 32. The physician then advances theballoon 700 into and through thelumen 624 of thedelivery catheter 622 until theballoon 700 and a distal portion of theballoon catheter 612 exit thedistal end 626 of thedelivery catheter 622 into theleft atrium 32, as illustrated inFIG. 33B . After theballoon 700 exits thedelivery catheter 622, the physician, in one embodiment, expands thedistal locator 630, as illustrated inFIG. 33C . - With the
locator 630 expanded as illustrated inFIG. 33C , the physician withdraws thedelivery catheter 622 and theballoon 700 proximally into thepatent foramen ovale 44. The physician continues to withdraw thedelivery catheter 622 and theballoon 700 into thepatent foramen ovale 44 until thelocator 630 abuts the distal walls of theseptum secundum 36 and theseptum primum 40, as illustrated inFIG. 33D . - Alternatively, in another embodiment, after the physician positions the
distal end 626 of thedelivery catheter 622 in theleft atrium 32, as illustrated inFIG. 33A , rather than both deploying theballoon 700 and expanding thedistal locator 630 in theleft atrium 32, as illustrated inFIG. 33C , the physician only expands thelocator 630 in theleft atrium 32. The physician then positions thelocator 630 to abut the distal walls of theseptum secundum 36 and theseptum primum 40. Once thelocator 630 is positioned as such, the physician removes thedelivery catheter 622 from about theballoon 700 to deploy theballoon 700 within thepatent foramen ovale 44, as illustrated inFIG. 33D . - Optionally, when the
balloon 700 is deployed within thepatent foramen ovale 44 as illustrated inFIG. 33D , the physician then expands theproximal locator 628 in theright atrium 26, as illustrated inFIG. 33E . In one particular embodiment, thelocators right atrium 26 and theleft atrium 32, respectively. Together, thelocators balloon 700 within thepatent foramen ovale 44. - After the physician correctly positions the
balloon 700 within the cardiac opening, as depicted inFIGS. 32D and 33E , the physician exposes the adhesive of theballoon 700 to the cardiac opening. As described above, the physician may accomplish this step in a variety of manners, depending on the type ofballoon 700 that has been positioned within the cardiac opening. - In an exemplary embodiment, a deflated
balloon 700 f is positioned within the cardiac opening and, subsequent to placement within the cardiac opening, is inflated, as illustrated inFIG. 28 . Where theballoon 700 f includes thedivider 1172 containing theprimer 1184, the physician first applies theprimer 1184 to the patient's tissue surface within the cardiac opening. In one embodiment, the physician does so by contacting the patient's tissues within the cardiac opening with theprimer 1184 contained on thesecond surface 1180 of thedivider 1172. The physician then removes thedivider 1172 from about theballoon 700 f. - After applying the
primer 1184 to the tissue surface of the cardiac opening and removing thedivider 1172, the physician further inflates theballoon 700 f to contact the tissue surface of the cardiac opening with the adhesive 1116A. Alternatively, where theballoon 700 f does not include thedivider 1172 and theprimer 1184, the physician simply inflates theballoon 700 f to contact the tissue surface of the cardiac opening with the adhesive 1116A immediately following the placement of theballoon 700 f within the cardiac opening. - With the adhesive 1116A of the
balloon 700 f in contact with the patient's tissues in the cardiac opening, the physician activates the adhesive 1116A to cure the adhesive 1116A to the patient's tissues. In one embodiment, the physician illuminates the adhesive 1116A to activate the adhesive 1116A. - In various embodiments, once the adhesive is exposed to the tissue surface of the cardiac opening or the cardiac cul-de-sac, the physician allows the adhesive to cure and to thereby glue the
balloon 700 to the tissue surface within the cardiac opening or the cardiac cul-de-sac. As such, theentire balloon 700 is coupled to the cardiac opening or the cardiac cul-de-sac to substantially occlude the cardiac opening or obliterate the cardiac cul-de-sac. Where, for example, the cardiac cul-de-sac is the leftatrial appendage 80, the physician may couple theentire balloon 700 to the tissue surface of the leftatrial appendage 80 to substantially obliterate the leftatrial appendage 80. As another example, where the physician has positioned theballoon 700 f within apatent foramen ovale 44 and activated the adhesive 1116A, the physician allows the adhesive 1116A to cure and to thereby couple theentire balloon 700 f to the tissue surface of thepatent foramen ovale 44. The physician may then separate and remove theballoon catheter 612 from theballoon 700 f and deflate theballoon 700 to draw theseptum secundum 36 and the septum primum 40 together. Once theballoon 700 f is deflated, the adhesive 1116B, which is coated on theinner surface 1112 of theballoon 700 f, glues portions of theinner surface 1112 of theballoon 700 f together. - Where the physician couples the
entire balloon 700 to the cardiac opening, the physician may also couple thelocators locators locators locators entire balloon 700 is coupled to the cardiac opening. For example, in one embodiment, the physician collapses theproximal locator 628 and removes it, along with theballoon catheter 612, from the patient's body. In another embodiment, thedistal locator 630 is collapsed and proximally withdrawn, along with theballoon catheter 612, through thedistal opening 635, through thelumen 631, and through theproximal opening 633 of theballoon 700 for removal from the patient's body. - In another embodiment, where the cardiac opening being closed is a
patent foramen ovale 44, after the adhesive is exposed to the tissue surface of thepatent foramen ovale 44 and is applied thereto, but before the adhesive has cured, the physician removes theballoon 700, theballoon catheter 612, and the one ormore locators patent foramen ovale 44. In such a case, the natural pressure difference between theright atrium 26 and theleft atrium 32 will eventually cause theseptum secundum 36 to contact theseptum primum 40. Because theseptum secundum 36 and the septum primum 40 are coated with the adhesive, they will eventually bond together, thereby permanently closing thepatent foramen ovale 44. Alternatively, in other embodiments, while removing theballoon 700 from thepatent foramen ovale 44, the physician permanently glues one or bothlocators patent foramen ovale 44. Thelocators patent foramen ovale 44. - In yet another embodiment, the substance for stimulating tissue growth is combined with the adhesive of the
balloon 700, or is used in place of the adhesive, and is delivered to, or impregnated within, the tissue surface of the patient's cardiac opening in a manner similar to that described above for the adhesives. In one embodiment, for example, theballoon 700 is used to deliver the growth substance to a patient's tissue surface located within apatent foramen ovale 44. Theballoon 700 is then removed from thepatent foramen ovale 44. The growth substance, having been applied to theseptum secundum 36 and theseptum primum 40, then stimulates tissue growth within thepatent foramen ovale 44. The newly grown tissue leads to the closure of thepatent foramen ovale 44. - In yet another aspect, the invention provides methods for percutaneously closing a
patent foramen ovale 44 using theexemplary closure system 600 depicted inFIGS. 30 and 31 . In one embodiment, a physician advances theclosure system 600 into the patient's heart with thesock catheter 612′ retracted, as illustrated inFIG. 30 . The physician then positions thedistal end 626 of thedelivery catheter 622 in theright atrium 26 proximate thepatent foramen ovale 44, as illustrated, for example, inFIG. 34A . With theclosure system 600 positioned as such, thesock catheter 612′ is deployed to invert the lining 634 within thepatent foramen ovale 44. Accordingly, as described above, the adhesive 639 and/or the substance for stimulating tissue growth is exposed to the patient's tissue surface located within thepatent foramen ovale 44, as illustrated inFIG. 34B , and is applied thereto. The physician then retracts thesock catheter 612′ to remove the lining 634 from thepatent foramen ovale 44. Accordingly, as described above, the natural pressure difference between theright atrium 26 and theleft atrium 32 causes the septum primum 36 and the septum secundum 30 to bond together, and/or natural tissue growth is stimulated within thepatent foramen ovale 44, thereby leading to closure of thepatent foramen ovale 44. - Variations, modifications, and other implementations of what is described herein will occur to those of ordinary skill in the art without departing from the spirit and the scope of the invention. The invention is not to be defined only by the preceding illustrative description.
Claims (82)
1. A system for percutaneous transluminal closure of a cardiac opening, comprising:
a balloon for application of an adhesive comprising an outer surface, the balloon transitionable between a deflated state and an inflated state;
a catheter comprising a length between a proximal end and a distal end, wherein said balloon is joined to the distal end of the catheter; and
a first locator joined to said catheter, wherein said locator positions said balloon in said cardiac opening.
2. The system of claim 1 , wherein the first locator comprises a disk.
3. The system of claim 1 , wherein the first locator comprises a plurality of arms.
4. The system of claim 1 , wherein the first locator comprises a rod.
5. The system of claim 1 , wherein the first locator comprises a locator balloon.
6. The system of claim 1 , wherein the first locator comprises a right atrial locator.
7. The system of claim 1 , wherein the first locator comprises a left atrial locator.
8. The system of claim 1 further comprising a second locator coupled to at least one of the catheter and the balloon, the second locator for positioning the closure device in the cardiac opening.
9. The system of claim 1 further comprising an adhesive coated on the first locator.
10. The system of claim 1 further comprising a second locator.
11. The system of claim 1 , wherein the adhesive comprises a cyanoacrylate.
12. The system of claim 1 , wherein the adhesive comprises a fibrin based adhesive.
13. The system of claim 1 , wherein the adhesive comprises an albumin gluteraldehyde type adhesive.
14. The system of claim 1 further comprising an adhesive coated on the first locator.
15. The system of claim 8 further comprising an adhesive coated on the second locator.
16. The system of claim 14 , wherein the adhesive comprises a cyanoacrylate.
17. The system of claim 14 , wherein the adhesive comprises a fibrin based adhesive.
18. The system of claim 14 , wherein the adhesive comprises an albumin gluteraldehyde type adhesive.
19. The system of claim 1 , wherein the adhesive comprises a light activated adhesive.
20. The system of claim 1 further comprising a light source coupled to the catheter for activating the light activated adhesive.
21. The system of claim 1 further comprising an adhesive coated on an outer surface of the balloon.
22. The system of claim 1 further comprising an adhesive coated on an inner surface of the balloon.
23. The system of claim 1 , wherein the balloon is tubular-shaped.
24. The system of claim 1 , wherein the balloon comprises a plurality of holes.
25. The system of claim 24 , wherein the holes comprise slits.
26. The system of claim 24 , wherein the adhesive is contained within the balloon.
27. The system of claim 1 , wherein the adhesive is disposed on the surface of the balloon.
28. The system of claim 27 , wherein the surface of the balloon is involuted.
29. The system of claim 1 , wherein the balloon is adapted to deliver the adhesive from the inner lumen of the balloon to the exterior surface of the balloon by capillary action.
30. The system of claim 1 , wherein the balloon is detachable from the distal end of the catheter.
31. The system of claim 30 , wherein the first locator is attached to the balloon.
32. The system of claim 1 , wherein the adhesive comprises an irritant.
33. The system of claim 1 , wherein the adhesive comprises a tissue growth stimulator.
34. A closure device for percutaneous transluminal closure of a cardiac opening, comprising:
a balloon comprising an outer surface, the balloon inflatable between a deflated state and an inflated state, wherein in the deflated state the outer surface of the balloon involutes to form a cavity, and wherein in the inflated state the cavity unfolds to form the outer surface of the balloon; and
an adhesive, wherein in the deflated state the adhesive is coated on a surface of the cavity, and wherein in the inflated state the adhesive is coated on the outer surface of the balloon.
35. The device of claim 34 , wherein the cavity is formed around a mid-portion of the balloon.
36. The device of claim 34 , wherein the balloon is tubularly-shaped.
37. The device of claim 34 , wherein the adhesive comprises cyanoacrylate.
38. The device of claim 34 , wherein the adhesive comprises a fibrin based adhesive.
39. The device of claim 34 , wherein the adhesive comprises an albumin gluteraldehyde type adhesive.
40. The device of claim 34 , wherein the adhesive comprises a light activated adhesive.
41. The device of claim 34 further comprising a substance for stimulating tissue growth, wherein in the deflated state the substance is coated on the surface of the cavity, and wherein in the inflated state the substance is coated on the outer surface of the balloon.
42. The device of claim 41 , wherein the substance is selected from the group consisting of a growth factor, a pharmacological agent for stimulating tissue growth, an irritant for encouraging an inflammatory response, a cell, and a gene.
43. A closure device for percutaneous transluminal closure of a cardiac opening, comprising:
a balloon comprising an outer surface;
a porous band comprising a plurality of openings, the porous band encircling only a portion of the outer surface of the balloon; and
an adhesive disposed between the outer surface of the balloon and the porous band.
44. The device of claim 43 , wherein the porous band encircles a center portion of the balloon.
45. The device of claim 43 , wherein the balloon is tubularly-shaped.
46. The device of claim 43 , wherein the adhesive comprises cyanoacrylate.
47. The device of claim 43 , wherein the adhesive comprises a fibrin based adhesive.
48. The device of claim 43 , wherein the adhesive comprises an albumin gluteraldehyde type adhesive.
49. The device of claim 43 , wherein the adhesive comprises a light activated adhesive.
50. The device of claim 43 further comprising a substance for stimulating tissue growth, wherein the substance is disposed between the outer surface of the balloon and the porous band.
51. The device of claim 50 , wherein the substance is selected from the group consisting of a growth factor, a pharmacological agent for stimulating tissue growth, an irritant for encouraging an inflammatory response, a cell, and a gene.
52. A closure device for percutaneous transluminal closure of a cardiac opening, comprising:
an outer balloon comprising a plurality of first holes;
an inner balloon comprising a plurality of second holes, the inner balloon contained within the outer balloon; and
an adhesive contained within the inner balloon.
53. The device of claim 52 , wherein at least one of the plurality of first holes and the plurality of second holes comprises pores.
54. The device of claim 52 , wherein at least one of the plurality of first holes and the plurality of second holes comprises slits.
55. The device of claim 52 , wherein at least one of the inner balloon and the outer balloon is tubularly-shaped.
56. The device of claim 52 , wherein the adhesive comprises cyanoacrylate.
57. The device of claim 52 , wherein the adhesive comprises a fibrin based adhesive.
58. The device of claim 52 , wherein the adhesive comprises an albumin gluteraldehyde type adhesive.
59. The device of claim 52 , wherein the adhesive comprises a light activated adhesive.
60. The device of claim 52 further comprising a substance for stimulating tissue growth, wherein the substance is contained within the inner balloon.
61. The device of claim 60 , wherein the substance is selected from the-group consisting of a growth factor, a pharmacological agent for stimulating tissue growth, an irritant for encouraging an inflammatory response, a cell, and a gene.
62. A closure device for percutaneous transluminal closure of a cardiac opening, comprising:
a balloon comprising a membrane constructed from a wicking material; and
an adhesive contained within the membrane of the balloon.
63. The device of claim 62 , wherein the balloon is tubularly-shaped.
64. The device of claim 62 , wherein the adhesive comprises cyanoacrylate.
65. The device of claim 62 , wherein the adhesive comprises a fibrin based adhesive.
66. The device of claim 62 , wherein the adhesive comprises an albumin gluteraldehyde type adhesive.
67. The device of claim 62 , wherein the adhesive comprises a light activated adhesive.
68. The device of claim 62 further comprising a substance for stimulating tissue growth, wherein the substance is contained within the membrane of the balloon.
69. The device of claim 68 , wherein the substance is selected from the group consisting of a growth factor, a pharmacological agent for stimulating tissue growth, an irritant for encouraging an inflammatory response, a cell, and a gene.
70. The device of claim 62 , wherein at least a portion of the adhesive is absorbed within the membrane of the balloon.
71. A method for percutaneous transluminal closure of a cardiac opening in a patient, comprising:
inserting a closure device into a heart of the patient, the closure device comprising:
a balloon comprising an outer surface, the balloon inflatable between a deflated state and an inflated state, wherein in the deflated state the outer surface of the balloon involutes to form a cavity, and wherein in the inflated state the cavity unfolds to form the outer surface of the balloon; and
an adhesive, wherein in the deflated state the adhesive is coated on a surface of the cavity, and wherein in the inflated state the adhesive is coated on the outer surface of the balloon.
positioning the closure device within the cardiac opening with the balloon in the deflated state; and
inflating the balloon to expose the adhesive to the cardiac opening.
72. The method of claim 71 further comprising removing the balloon of the closure device from the patient after the adhesive is exposed to the cardiac opening.
73. The method of claim 71 , wherein the cardiac opening is a patent foramen ovale.
74. A method for percutaneous transluminal closure of a cardiac opening in a patient, comprising:
inserting a closure device into a heart of the patient, the closure device comprising:
a balloon comprising an outer surface;
a porous band comprising a plurality of openings, the porous band encircling only a portion of the outer surface of the balloon; and
an adhesive disposed between the outer surface of the balloon and the porous band;
positioning the closure device within the cardiac opening; and
applying a pressure to the balloon of the closure device to expose the adhesive through the plurality of openings of the porous band to the cardiac opening.
75. The method of claim 74 further comprising removing the balloon and the porous band of the closure device from the patient after the adhesive is exposed through the plurality of openings of the porous band to the cardiac opening.
76. The method of claim 74 wherein the cardiac opening is a patent foramen ovale.
77. A method for percutaneous transluminal closure of a cardiac opening in a patient, comprising:
inserting a closure device into a heart of the patient, the closure device comprising:
an outer balloon comprising a plurality of first holes;
an inner balloon comprising a plurality of second holes, the inner balloon contained within the outer balloon; and
an adhesive contained within the inner balloon;
positioning the closure device within the cardiac opening;
applying a first pressure to the inner balloon to express the adhesive through the plurality of second holes; and
applying a second pressure to the outer balloon to express the adhesive through the plurality of first holes to the cardiac opening.
78. The method of claim 77 further comprising removing the outer balloon and the inner balloon of the closure device from the patient after the adhesive is expressed through the plurality of first holes to the cardiac opening.
79. The method of claim 77 , wherein the cardiac opening is a patent foramen ovale.
80. A method for percutaneous transluminal closure of a cardiac opening in a patient, comprising:
inserting a closure device into a heart of the patient, the closure device comprising:
a balloon comprising a membrane constructed from a wicking material; and
an adhesive contained within the membrane of the balloon;
positioning the closure device within the cardiac opening; and
contacting a tissue surface of the cardiac opening with the membrane of the balloon to apply-the adhesive to the tissue surface of the cardiac opening.
81. The method of claim 80 further comprising removing the balloon of the closure device from the patient after the adhesive is applied to the tissue surface of the cardiac opening.
82. The method of claim 80 wherein the cardiac opening is a patent foramen ovale.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US13/609,129 US20130018414A1 (en) | 2004-01-30 | 2012-09-10 | Devices, Systems and Methods for Closure of Cardiac Openings |
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US54047404P | 2004-01-30 | 2004-01-30 | |
US54082104P | 2004-01-30 | 2004-01-30 | |
US54082704P | 2004-01-30 | 2004-01-30 | |
US11/045,027 US8262694B2 (en) | 2004-01-30 | 2005-01-27 | Devices, systems, and methods for closure of cardiac openings |
US13/609,129 US20130018414A1 (en) | 2004-01-30 | 2012-09-10 | Devices, Systems and Methods for Closure of Cardiac Openings |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US11/045,027 Continuation US8262694B2 (en) | 2004-01-30 | 2005-01-27 | Devices, systems, and methods for closure of cardiac openings |
Publications (1)
Publication Number | Publication Date |
---|---|
US20130018414A1 true US20130018414A1 (en) | 2013-01-17 |
Family
ID=34841729
Family Applications (4)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US11/044,657 Expired - Fee Related US7988690B2 (en) | 2004-01-30 | 2005-01-27 | Welding systems useful for closure of cardiac openings |
US13/189,438 Expired - Fee Related US8348945B2 (en) | 2004-01-30 | 2011-07-22 | Welding systems useful for closure of cardiac openings |
US13/609,129 Abandoned US20130018414A1 (en) | 2004-01-30 | 2012-09-10 | Devices, Systems and Methods for Closure of Cardiac Openings |
US13/715,831 Abandoned US20130103034A1 (en) | 2004-01-30 | 2012-12-14 | Welding Systems Useful for Closure of Cardiac Openings |
Family Applications Before (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US11/044,657 Expired - Fee Related US7988690B2 (en) | 2004-01-30 | 2005-01-27 | Welding systems useful for closure of cardiac openings |
US13/189,438 Expired - Fee Related US8348945B2 (en) | 2004-01-30 | 2011-07-22 | Welding systems useful for closure of cardiac openings |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US13/715,831 Abandoned US20130103034A1 (en) | 2004-01-30 | 2012-12-14 | Welding Systems Useful for Closure of Cardiac Openings |
Country Status (5)
Country | Link |
---|---|
US (4) | US7988690B2 (en) |
EP (2) | EP1715792A2 (en) |
JP (2) | JP2007519489A (en) |
CA (2) | CA2553869A1 (en) |
WO (2) | WO2005074517A2 (en) |
Cited By (23)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2016077783A1 (en) * | 2014-11-14 | 2016-05-19 | Cedars-Sinai Medical Center | Cardiovascular access and device delivery system |
US20160192912A1 (en) * | 2007-01-23 | 2016-07-07 | Cvdevices, Llc | Devices, systems, and methods for atrial appendage occlusion using light cure |
US20160192911A1 (en) * | 2007-01-23 | 2016-07-07 | Cvdevices, Llc | Devices, systems, and hybrid methods for atrial appendage occlusion using light cure |
US9763658B2 (en) | 2002-08-02 | 2017-09-19 | Cedars-Sinai Medical Center | Methods and apparatus for atrioventricular valve repair |
US10080657B2 (en) | 2013-03-07 | 2018-09-25 | Cedars-Sinai Medical Center | Catheter based apical approach heart prostheses delivery system |
US10105221B2 (en) | 2013-03-07 | 2018-10-23 | Cedars-Sinai Medical Center | Method and apparatus for percutaneous delivery and deployment of a cardiovascular prosthesis |
US10349948B2 (en) | 2014-03-31 | 2019-07-16 | Jitmed Sp. Z. O.O. | Left atrial appendage occlusion device |
WO2020010144A1 (en) * | 2018-07-03 | 2020-01-09 | Subramaniam Krishnan | Systems and methods for treating patent foramen ovale |
US10617425B2 (en) | 2014-03-10 | 2020-04-14 | Conformal Medical, Inc. | Devices and methods for excluding the left atrial appendage |
US10722240B1 (en) | 2019-02-08 | 2020-07-28 | Conformal Medical, Inc. | Devices and methods for excluding the left atrial appendage |
CN111528951A (en) * | 2019-02-06 | 2020-08-14 | 德普伊新特斯产品公司 | Adhesive cover occlusion device for aneurysm treatment |
US10799359B2 (en) | 2014-09-10 | 2020-10-13 | Cedars-Sinai Medical Center | Method and apparatus for percutaneous delivery and deployment of a cardiac valve prosthesis |
US10918392B2 (en) | 2018-01-26 | 2021-02-16 | Syntheon 2.0, LLC | Left atrial appendage clipping device and methods for clipping the LAA |
US10925615B2 (en) | 2019-05-03 | 2021-02-23 | Syntheon 2.0, LLC | Recapturable left atrial appendage clipping device and methods for recapturing a left atrial appendage clip |
US11026695B2 (en) | 2016-10-27 | 2021-06-08 | Conformal Medical, Inc. | Devices and methods for excluding the left atrial appendage |
WO2021220223A1 (en) * | 2020-04-30 | 2021-11-04 | Ethicon, Inc. | Systems and methods for sealing cored or punctured tissue using inflatable balloon |
US20210361269A1 (en) * | 2020-05-21 | 2021-11-25 | St. Jude Medical, Cardiology Division, Inc. | Biomaterial occluder delivery mechanism |
US11241308B2 (en) | 2015-07-23 | 2022-02-08 | Cedars-Sinai Medical Center | Device for securing heart valve leaflets |
US11291544B2 (en) | 2018-02-02 | 2022-04-05 | Cedars-Sinai Medical Center | Delivery platforms, devices, and methods for tricuspid valve repair |
US11399842B2 (en) | 2013-03-13 | 2022-08-02 | Conformal Medical, Inc. | Devices and methods for excluding the left atrial appendage |
US11426172B2 (en) | 2016-10-27 | 2022-08-30 | Conformal Medical, Inc. | Devices and methods for excluding the left atrial appendage |
US11439501B2 (en) | 2017-01-25 | 2022-09-13 | Cedars-Sinai Medical Center | Device for securing heart valve leaflets |
US11717303B2 (en) | 2013-03-13 | 2023-08-08 | Conformal Medical, Inc. | Devices and methods for excluding the left atrial appendage |
Families Citing this family (170)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6776784B2 (en) | 2001-09-06 | 2004-08-17 | Core Medical, Inc. | Clip apparatus for closing septal defects and methods of use |
US20060052821A1 (en) | 2001-09-06 | 2006-03-09 | Ovalis, Inc. | Systems and methods for treating septal defects |
US6702835B2 (en) | 2001-09-07 | 2004-03-09 | Core Medical, Inc. | Needle apparatus for closing septal defects and methods for using such apparatus |
US7223266B2 (en) | 2003-02-04 | 2007-05-29 | Cardiodex Ltd. | Methods and apparatus for hemostasis following arterial catheterization |
US8021359B2 (en) | 2003-02-13 | 2011-09-20 | Coaptus Medical Corporation | Transseptal closure of a patent foramen ovale and other cardiac defects |
US7972330B2 (en) | 2003-03-27 | 2011-07-05 | Terumo Kabushiki Kaisha | Methods and apparatus for closing a layered tissue defect |
US7165552B2 (en) | 2003-03-27 | 2007-01-23 | Cierra, Inc. | Methods and apparatus for treatment of patent foramen ovale |
US7293562B2 (en) | 2003-03-27 | 2007-11-13 | Cierra, Inc. | Energy based devices and methods for treatment of anatomic tissue defects |
US8021362B2 (en) | 2003-03-27 | 2011-09-20 | Terumo Kabushiki Kaisha | Methods and apparatus for closing a layered tissue defect |
US20040267191A1 (en) | 2003-03-27 | 2004-12-30 | Cierra, Inc. | Methods and apparatus for treatment of patent foramen ovale |
US6939348B2 (en) | 2003-03-27 | 2005-09-06 | Cierra, Inc. | Energy based devices and methods for treatment of patent foramen ovale |
US7186251B2 (en) | 2003-03-27 | 2007-03-06 | Cierra, Inc. | Energy based devices and methods for treatment of patent foramen ovale |
JP4547381B2 (en) | 2003-05-19 | 2010-09-22 | セプトアールエックス インコーポレイテッド | Therapeutic tissue expansion device and related methods |
US7311701B2 (en) | 2003-06-10 | 2007-12-25 | Cierra, Inc. | Methods and apparatus for non-invasively treating atrial fibrillation using high intensity focused ultrasound |
US7056286B2 (en) | 2003-11-12 | 2006-06-06 | Adrian Ravenscroft | Medical device anchor and delivery system |
US7367975B2 (en) | 2004-06-21 | 2008-05-06 | Cierra, Inc. | Energy based devices and methods for treatment of anatomic tissue defects |
US20070016272A1 (en) | 2004-09-27 | 2007-01-18 | Thompson Russell B | Systems and methods for treating a hollow anatomical structure |
JP5068662B2 (en) | 2004-11-22 | 2012-11-07 | カーディオデックス リミテッド | Heat treatment technology for varicose veins |
US8920434B2 (en) * | 2005-03-02 | 2014-12-30 | St. Jude Medical, Cardiology Division, Inc. | Remote body tissue engaging methods and apparatus |
AU2006235506B2 (en) * | 2005-04-11 | 2011-06-30 | Terumo Kabushiki Kaisha | Methods and apparatus to achieve a closure of a layered tissue defect |
US20060247667A1 (en) * | 2005-04-28 | 2006-11-02 | Ahern John E | System and method for bonding closure of an intra-cardiac opening using energy |
US8579936B2 (en) | 2005-07-05 | 2013-11-12 | ProMed, Inc. | Centering of delivery devices with respect to a septal defect |
JP5030180B2 (en) | 2005-07-21 | 2012-09-19 | タイコ ヘルスケア グループ リミテッド パートナーシップ | System and method for treating anatomical hollow structures |
US7846179B2 (en) | 2005-09-01 | 2010-12-07 | Ovalis, Inc. | Suture-based systems and methods for treating septal defects |
WO2007030486A1 (en) * | 2005-09-06 | 2007-03-15 | Nmt Medical, Inc. | In tunnel electrode for sealing intracardiac defects |
US7799023B2 (en) * | 2005-09-26 | 2010-09-21 | Coherex Medical, Inc. | Compliant electrode for patent foramen ovale closure device |
US20070123824A1 (en) * | 2005-10-17 | 2007-05-31 | Coaptus Medical Corporation | Systems and methods for directing valves that control a vacuum applied to a patient |
US9427216B2 (en) | 2005-12-23 | 2016-08-30 | CARDINAL HEALTH SWITZERLAND 515 GmbH | Systems and methods for closing a vessel wound |
DE102005062658B3 (en) * | 2005-12-28 | 2007-05-31 | Osypka, Peter, Dr.-Ing. | Device for occluding opening between two heart chambers formed by two overlapping tissue lobes in heart, has connecting mechanism which has screw catheter that dilates at its distal end and is movable into feed catheter |
US8221405B2 (en) * | 2006-02-06 | 2012-07-17 | Coherex Medical, Inc. | Patent foramen ovale closure device and methods for determining RF dose for patent foramen ovale closure |
CN101389282B (en) | 2006-02-24 | 2011-03-09 | 泰尔茂株式会社 | Pfo closing device |
US8029498B2 (en) * | 2006-03-14 | 2011-10-04 | Kci Licensing Inc. | System for percutaneously administering reduced pressure treatment using balloon dissection |
WO2007112578A1 (en) * | 2006-04-04 | 2007-10-11 | University Health Network | A coil electrode apparatus for thermal therapy |
US8402974B2 (en) * | 2006-05-30 | 2013-03-26 | Coherex Medical, Inc. | Methods, systems, and devices for sensing, measuring, and controlling closure of a patent foramen ovale |
US7938826B2 (en) * | 2006-05-30 | 2011-05-10 | Coherex Medical, Inc. | Methods, systems, and devices for closing a patent foramen ovale using mechanical structures |
US20080051830A1 (en) * | 2006-08-24 | 2008-02-28 | Boston Scientific Scimed, Inc. | Occluding device and method |
AU2007216674A1 (en) * | 2006-09-21 | 2008-04-10 | Cathrx Ltd | A catheter assembly |
WO2008066920A2 (en) * | 2006-11-28 | 2008-06-05 | Stryker Development Llc | Gastrotomy closure device |
US20080140069A1 (en) * | 2006-12-07 | 2008-06-12 | Cierra, Inc. | Multi-electrode apparatus for tissue welding and ablation |
US7655004B2 (en) | 2007-02-15 | 2010-02-02 | Ethicon Endo-Surgery, Inc. | Electroporation ablation apparatus, system, and method |
US8075572B2 (en) | 2007-04-26 | 2011-12-13 | Ethicon Endo-Surgery, Inc. | Surgical suturing apparatus |
US8100922B2 (en) | 2007-04-27 | 2012-01-24 | Ethicon Endo-Surgery, Inc. | Curved needle suturing tool |
EP2008600B1 (en) * | 2007-06-25 | 2010-09-22 | Terumo Kabushiki Kaisha | Medical device |
JP5349852B2 (en) | 2007-06-25 | 2013-11-20 | テルモ株式会社 | Medical device |
JP2010536437A (en) | 2007-08-15 | 2010-12-02 | カーディオデックス リミテッド | System and method for occluding a puncture |
WO2009028285A1 (en) * | 2007-08-28 | 2009-03-05 | Terumo Kabushiki Kaisha | Device for opening/closing biological tissue |
JP2009050589A (en) * | 2007-08-28 | 2009-03-12 | Terumo Corp | Pfo closing device |
JP2009050588A (en) * | 2007-08-28 | 2009-03-12 | Terumo Corp | Pfo closing device |
US8568410B2 (en) | 2007-08-31 | 2013-10-29 | Ethicon Endo-Surgery, Inc. | Electrical ablation surgical instruments |
US8262655B2 (en) | 2007-11-21 | 2012-09-11 | Ethicon Endo-Surgery, Inc. | Bipolar forceps |
US8579897B2 (en) | 2007-11-21 | 2013-11-12 | Ethicon Endo-Surgery, Inc. | Bipolar forceps |
WO2009046356A1 (en) * | 2007-10-05 | 2009-04-09 | Cardiodex Ltd. | Systems and methods for puncture closure |
EP2205309A4 (en) | 2007-10-05 | 2011-05-11 | Coaptus Medical Corp | Systems and methods for transeptal cardiac procedures |
US20090112059A1 (en) | 2007-10-31 | 2009-04-30 | Nobis Rudolph H | Apparatus and methods for closing a gastrotomy |
US8480657B2 (en) | 2007-10-31 | 2013-07-09 | Ethicon Endo-Surgery, Inc. | Detachable distal overtube section and methods for forming a sealable opening in the wall of an organ |
FR2924018B1 (en) * | 2007-11-23 | 2010-12-24 | Protomed | DEVICE FOR IMPLANTATION OF A VASCULAR PROSTHESIS |
US8545573B2 (en) * | 2008-02-12 | 2013-10-01 | Cook Medical Technologies Llc | Spiral occluding device with an occlusion sail |
US8262680B2 (en) | 2008-03-10 | 2012-09-11 | Ethicon Endo-Surgery, Inc. | Anastomotic device |
US8317806B2 (en) | 2008-05-30 | 2012-11-27 | Ethicon Endo-Surgery, Inc. | Endoscopic suturing tension controlling and indication devices |
US8070759B2 (en) | 2008-05-30 | 2011-12-06 | Ethicon Endo-Surgery, Inc. | Surgical fastening device |
US8679003B2 (en) | 2008-05-30 | 2014-03-25 | Ethicon Endo-Surgery, Inc. | Surgical device and endoscope including same |
US8114072B2 (en) | 2008-05-30 | 2012-02-14 | Ethicon Endo-Surgery, Inc. | Electrical ablation device |
US8771260B2 (en) | 2008-05-30 | 2014-07-08 | Ethicon Endo-Surgery, Inc. | Actuating and articulating surgical device |
US8652150B2 (en) | 2008-05-30 | 2014-02-18 | Ethicon Endo-Surgery, Inc. | Multifunction surgical device |
US8906035B2 (en) | 2008-06-04 | 2014-12-09 | Ethicon Endo-Surgery, Inc. | Endoscopic drop off bag |
US8403926B2 (en) | 2008-06-05 | 2013-03-26 | Ethicon Endo-Surgery, Inc. | Manually articulating devices |
US8361112B2 (en) | 2008-06-27 | 2013-01-29 | Ethicon Endo-Surgery, Inc. | Surgical suture arrangement |
EP2293723A4 (en) * | 2008-07-01 | 2015-04-01 | Boston Scient Scimed Inc | Dissecting-swatting surgical stapling device and device and methods of use |
US8262563B2 (en) | 2008-07-14 | 2012-09-11 | Ethicon Endo-Surgery, Inc. | Endoscopic translumenal articulatable steerable overtube |
US8888792B2 (en) | 2008-07-14 | 2014-11-18 | Ethicon Endo-Surgery, Inc. | Tissue apposition clip application devices and methods |
US8211125B2 (en) | 2008-08-15 | 2012-07-03 | Ethicon Endo-Surgery, Inc. | Sterile appliance delivery device for endoscopic procedures |
US9603558B2 (en) | 2008-08-15 | 2017-03-28 | Theranova, Llc | Methods and devices for the diagnosis and treatment of diabetes |
US8529563B2 (en) | 2008-08-25 | 2013-09-10 | Ethicon Endo-Surgery, Inc. | Electrical ablation devices |
US8241204B2 (en) | 2008-08-29 | 2012-08-14 | Ethicon Endo-Surgery, Inc. | Articulating end cap |
US8480689B2 (en) | 2008-09-02 | 2013-07-09 | Ethicon Endo-Surgery, Inc. | Suturing device |
US8409200B2 (en) | 2008-09-03 | 2013-04-02 | Ethicon Endo-Surgery, Inc. | Surgical grasping device |
US8114119B2 (en) | 2008-09-09 | 2012-02-14 | Ethicon Endo-Surgery, Inc. | Surgical grasping device |
US8337394B2 (en) | 2008-10-01 | 2012-12-25 | Ethicon Endo-Surgery, Inc. | Overtube with expandable tip |
US20100094277A1 (en) * | 2008-10-09 | 2010-04-15 | Olympus Medical Systems Corp. | High-frequency surgical device and method |
US8095212B2 (en) | 2008-10-24 | 2012-01-10 | Olympus Medical Systems Corp. | High-frequency surgical apparatus and high-frequency surgical method for closure of patent foramen ovale |
US8157834B2 (en) | 2008-11-25 | 2012-04-17 | Ethicon Endo-Surgery, Inc. | Rotational coupling device for surgical instrument with flexible actuators |
US8172772B2 (en) | 2008-12-11 | 2012-05-08 | Ethicon Endo-Surgery, Inc. | Specimen retrieval device |
US8361066B2 (en) | 2009-01-12 | 2013-01-29 | Ethicon Endo-Surgery, Inc. | Electrical ablation devices |
US8828031B2 (en) | 2009-01-12 | 2014-09-09 | Ethicon Endo-Surgery, Inc. | Apparatus for forming an anastomosis |
US9226772B2 (en) | 2009-01-30 | 2016-01-05 | Ethicon Endo-Surgery, Inc. | Surgical device |
US8252057B2 (en) | 2009-01-30 | 2012-08-28 | Ethicon Endo-Surgery, Inc. | Surgical access device |
US8037591B2 (en) | 2009-02-02 | 2011-10-18 | Ethicon Endo-Surgery, Inc. | Surgical scissors |
US20100249700A1 (en) * | 2009-03-27 | 2010-09-30 | Ethicon Endo-Surgery, Inc. | Surgical instruments for in vivo assembly |
US8282633B2 (en) * | 2009-06-15 | 2012-10-09 | Olympus Medical Systems Corp. | High-frequency surgical apparatus and high-frequency surgical method for closure of patent foramen ovale |
DE102009032972A1 (en) * | 2009-07-14 | 2011-01-20 | Erbe Elektromedizin Gmbh | Device for producing anastomoses |
DE102009036817A1 (en) | 2009-08-10 | 2011-02-17 | Acoredis Gmbh | Occlusion device, useful e.g. for closing the heart defects in a patient and other abnormal body openings, comprises mesh of fibers or film body of highly flexible, elastic materials, where the device is introduced through e.g. catheter |
US9072890B2 (en) * | 2009-09-03 | 2015-07-07 | Mayo Foundation For Medical Education And Research | Pacing, sensing or defibrillator leads for implantation into the myocardium |
US20110098704A1 (en) | 2009-10-28 | 2011-04-28 | Ethicon Endo-Surgery, Inc. | Electrical ablation devices |
US9649211B2 (en) | 2009-11-04 | 2017-05-16 | Confluent Medical Technologies, Inc. | Alternating circumferential bridge stent design and methods for use thereof |
US10092427B2 (en) | 2009-11-04 | 2018-10-09 | Confluent Medical Technologies, Inc. | Alternating circumferential bridge stent design and methods for use thereof |
US8608652B2 (en) | 2009-11-05 | 2013-12-17 | Ethicon Endo-Surgery, Inc. | Vaginal entry surgical devices, kit, system, and method |
US8496574B2 (en) | 2009-12-17 | 2013-07-30 | Ethicon Endo-Surgery, Inc. | Selectively positionable camera for surgical guide tube assembly |
US8353487B2 (en) | 2009-12-17 | 2013-01-15 | Ethicon Endo-Surgery, Inc. | User interface support devices for endoscopic surgical instruments |
US8506564B2 (en) | 2009-12-18 | 2013-08-13 | Ethicon Endo-Surgery, Inc. | Surgical instrument comprising an electrode |
DE102010019365A1 (en) | 2009-12-18 | 2011-06-22 | Acoredis GmbH, 07743 | Bioabsorbable occlusion device, which is introduced by a catheter in a folded condition in a patient's body, where the device in an area of its surrounding envelope comes to a constriction, useful to treat e.g. atrial septal defects |
US9028483B2 (en) | 2009-12-18 | 2015-05-12 | Ethicon Endo-Surgery, Inc. | Surgical instrument comprising an electrode |
US9005198B2 (en) | 2010-01-29 | 2015-04-14 | Ethicon Endo-Surgery, Inc. | Surgical instrument comprising an electrode |
CN102791212B (en) | 2010-03-11 | 2016-01-20 | 泰尔茂株式会社 | Medical device |
JP5916237B2 (en) | 2010-06-15 | 2016-05-11 | アベヌ メディカル インコーポレイテッドAvenu Medical,Inc. | Intravascular artery and vein anastomosis and tissue welding catheter |
JP2013252156A (en) * | 2010-09-29 | 2013-12-19 | Terumo Corp | Medical device |
US20120123326A1 (en) * | 2010-11-12 | 2012-05-17 | Christian Steven C | Catheter systems with distal end function, such as distal deflection, using remote actuation or low input force |
US10092291B2 (en) | 2011-01-25 | 2018-10-09 | Ethicon Endo-Surgery, Inc. | Surgical instrument with selectively rigidizable features |
US9943360B2 (en) | 2011-01-30 | 2018-04-17 | University Health Network | Coil electrode for thermal therapy |
US9233241B2 (en) | 2011-02-28 | 2016-01-12 | Ethicon Endo-Surgery, Inc. | Electrical ablation devices and methods |
US9314620B2 (en) | 2011-02-28 | 2016-04-19 | Ethicon Endo-Surgery, Inc. | Electrical ablation devices and methods |
US9254169B2 (en) | 2011-02-28 | 2016-02-09 | Ethicon Endo-Surgery, Inc. | Electrical ablation devices and methods |
WO2012125785A1 (en) | 2011-03-17 | 2012-09-20 | Ethicon Endo-Surgery, Inc. | Hand held surgical device for manipulating an internal magnet assembly within a patient |
GB201105622D0 (en) | 2011-04-01 | 2011-05-18 | Phangenesis Ltd | Multi functional catheter |
US9474575B2 (en) | 2011-04-22 | 2016-10-25 | Covidien Lp | System and method for UV tacking an implant |
JP2015057080A (en) * | 2012-01-12 | 2015-03-26 | テルモ株式会社 | Body tissue cauterization system |
CA2863248C (en) | 2012-02-08 | 2020-07-21 | Caymus Medical, Inc. | Intravascular arterial to venous anastomosis and tissue welding catheter |
US8986199B2 (en) | 2012-02-17 | 2015-03-24 | Ethicon Endo-Surgery, Inc. | Apparatus and methods for cleaning the lens of an endoscope |
US9161756B2 (en) * | 2012-03-16 | 2015-10-20 | Covidien Lp | Closure tape dispenser |
US9427255B2 (en) | 2012-05-14 | 2016-08-30 | Ethicon Endo-Surgery, Inc. | Apparatus for introducing a steerable camera assembly into a patient |
EP2861293A4 (en) * | 2012-06-19 | 2016-08-31 | Subramaniam Chitoor Krishnan | Apparatus and method for treating bleeding arising from left atrial appendage |
US10052168B2 (en) | 2012-06-19 | 2018-08-21 | Subramaniam Chitoor Krishnan | Methods and systems for preventing bleeding from the left atrial appendage |
US9078662B2 (en) | 2012-07-03 | 2015-07-14 | Ethicon Endo-Surgery, Inc. | Endoscopic cap electrode and method for using the same |
US9545290B2 (en) | 2012-07-30 | 2017-01-17 | Ethicon Endo-Surgery, Inc. | Needle probe guide |
US10314649B2 (en) | 2012-08-02 | 2019-06-11 | Ethicon Endo-Surgery, Inc. | Flexible expandable electrode and method of intraluminal delivery of pulsed power |
US9572623B2 (en) | 2012-08-02 | 2017-02-21 | Ethicon Endo-Surgery, Inc. | Reusable electrode and disposable sheath |
US9277957B2 (en) | 2012-08-15 | 2016-03-08 | Ethicon Endo-Surgery, Inc. | Electrosurgical devices and methods |
WO2014078601A1 (en) | 2012-11-14 | 2014-05-22 | Caymus Medical, Inc. | Intravascular arterial to venous anastomosis and tissue welding catheter |
US10098527B2 (en) | 2013-02-27 | 2018-10-16 | Ethidcon Endo-Surgery, Inc. | System for performing a minimally invasive surgical procedure |
US10314682B2 (en) | 2013-04-12 | 2019-06-11 | Covidien Lp | System and method having an electromagnetic manipulator with a UV tacking mechanism |
EP4088771A1 (en) * | 2013-08-07 | 2022-11-16 | Boston Scientific Medical Device Limited | Devices for puncturing tissue |
WO2015095538A1 (en) | 2013-12-20 | 2015-06-25 | Microvention, Inc. | Vascular occlusion |
US10772672B2 (en) | 2014-03-06 | 2020-09-15 | Avenu Medical, Inc. | Systems and methods for percutaneous access and formation of arteriovenous fistulas |
CN106028972A (en) * | 2014-03-12 | 2016-10-12 | 奥林巴斯株式会社 | Treatment device and treatment system |
WO2015148265A1 (en) | 2014-03-28 | 2015-10-01 | Spiration, Inc., d.b.a. Olympus Respiratory America | System for predictable deployment of a medical device |
US11076860B2 (en) | 2014-03-31 | 2021-08-03 | DePuy Synthes Products, Inc. | Aneurysm occlusion device |
US11154302B2 (en) | 2014-03-31 | 2021-10-26 | DePuy Synthes Products, Inc. | Aneurysm occlusion device |
US10588695B2 (en) * | 2014-05-14 | 2020-03-17 | President And Fellows Of Harvard College | Catheter device for transmitting and reflecting light |
EP4278989A3 (en) | 2015-08-21 | 2024-02-14 | Avenu Medical, Inc. | Systems and methods for percutaneous access and formation of arteriovenous fistulas |
DE112016003790B4 (en) | 2015-10-20 | 2022-06-09 | Gyrus Acmi, Inc. D/B/A Olympus Surgical Technologies America | Electrosurgical device |
US10272230B2 (en) * | 2015-10-30 | 2019-04-30 | Cerevasc, Llc | Systems and methods for treating hydrocephalus |
EP3231383B1 (en) * | 2016-04-12 | 2019-11-06 | Cook Medical Technologies LLC | Medical device |
WO2018141951A1 (en) * | 2017-02-06 | 2018-08-09 | Universitaet Zürich | Device and method for sealing a membrane |
MX2019010041A (en) | 2017-02-23 | 2020-01-13 | Depuy Synthes Products Inc | Aneurysm device and delivery system. |
CN116369997A (en) * | 2017-03-27 | 2023-07-04 | 波士顿科学国际有限公司 | System and method for influencing tissue structure movement |
CN110996805B (en) * | 2017-05-25 | 2024-03-19 | 泰尔茂株式会社 | Adhesive closure system |
WO2019079252A1 (en) * | 2017-10-20 | 2019-04-25 | Edwards Lifesciences Corporation | Localized fusion of native leaflets using activated adhesive |
US10905430B2 (en) | 2018-01-24 | 2021-02-02 | DePuy Synthes Products, Inc. | Aneurysm device and delivery system |
US11596412B2 (en) | 2018-05-25 | 2023-03-07 | DePuy Synthes Products, Inc. | Aneurysm device and delivery system |
US11058430B2 (en) | 2018-05-25 | 2021-07-13 | DePuy Synthes Products, Inc. | Aneurysm device and delivery system |
US10939915B2 (en) | 2018-05-31 | 2021-03-09 | DePuy Synthes Products, Inc. | Aneurysm device and delivery system |
CN112469342A (en) * | 2018-07-31 | 2021-03-09 | 波士顿科学国际有限公司 | Device and method for endoscopic patch delivery |
US11051825B2 (en) | 2018-08-08 | 2021-07-06 | DePuy Synthes Products, Inc. | Delivery system for embolic braid |
US11123077B2 (en) | 2018-09-25 | 2021-09-21 | DePuy Synthes Products, Inc. | Intrasaccular device positioning and deployment system |
US11076861B2 (en) | 2018-10-12 | 2021-08-03 | DePuy Synthes Products, Inc. | Folded aneurysm treatment device and delivery method |
US11564692B2 (en) | 2018-11-01 | 2023-01-31 | Terumo Corporation | Occlusion systems |
US11406392B2 (en) | 2018-12-12 | 2022-08-09 | DePuy Synthes Products, Inc. | Aneurysm occluding device for use with coagulating agents |
US11272939B2 (en) | 2018-12-18 | 2022-03-15 | DePuy Synthes Products, Inc. | Intrasaccular flow diverter for treating cerebral aneurysms |
DE102019101987A1 (en) * | 2019-01-28 | 2020-07-30 | Olympus Winter & Ibe Gmbh | Device for the transurethral treatment of benign prostatic hyperplasia |
US11337706B2 (en) | 2019-03-27 | 2022-05-24 | DePuy Synthes Products, Inc. | Aneurysm treatment device |
WO2020210818A1 (en) * | 2019-04-12 | 2020-10-15 | The Trustees Of Columbia University In The City Of New York | Transcatheter closure of patent foramen ovale with bipolar rf application |
JP2022531655A (en) * | 2019-05-07 | 2022-07-08 | シーアールシー イーピー、インコーポレイテッド | Mapping and cautery catheter with multiple loop segments |
US11497504B2 (en) | 2019-05-21 | 2022-11-15 | DePuy Synthes Products, Inc. | Aneurysm treatment with pushable implanted braid |
US11607226B2 (en) | 2019-05-21 | 2023-03-21 | DePuy Synthes Products, Inc. | Layered braided aneurysm treatment device with corrugations |
US11602350B2 (en) | 2019-12-05 | 2023-03-14 | DePuy Synthes Products, Inc. | Intrasaccular inverting braid with highly flexible fill material |
US11278292B2 (en) | 2019-05-21 | 2022-03-22 | DePuy Synthes Products, Inc. | Inverting braided aneurysm treatment system and method |
US11672542B2 (en) | 2019-05-21 | 2023-06-13 | DePuy Synthes Products, Inc. | Aneurysm treatment with pushable ball segment |
US11413046B2 (en) | 2019-05-21 | 2022-08-16 | DePuy Synthes Products, Inc. | Layered braided aneurysm treatment device |
US10653425B1 (en) | 2019-05-21 | 2020-05-19 | DePuy Synthes Products, Inc. | Layered braided aneurysm treatment device |
US11457926B2 (en) | 2019-12-18 | 2022-10-04 | DePuy Synthes Products, Inc. | Implant having an intrasaccular section and intravascular section |
JP6928399B1 (en) * | 2020-06-22 | 2021-09-01 | ネットビジネスコンサルティング株式会社 | Blocking device and manufacturing method of blocking device |
Citations (24)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4364392A (en) * | 1980-12-04 | 1982-12-21 | Wisconsin Alumni Research Foundation | Detachable balloon catheter |
US4471779A (en) * | 1976-08-25 | 1984-09-18 | Becton, Dickinson And Company | Miniature balloon catheter |
US5041090A (en) * | 1988-01-12 | 1991-08-20 | Scheglov Viktor I | Occluding device |
US5213576A (en) * | 1991-06-11 | 1993-05-25 | Cordis Corporation | Therapeutic porous balloon catheter |
US5405360A (en) * | 1992-02-24 | 1995-04-11 | United States Surgical Corporation | Resilient arm mesh deployer |
US5405472A (en) * | 1991-06-11 | 1995-04-11 | Cordis Corporation | Method of making infusion balloon catheter |
US5591205A (en) * | 1990-10-01 | 1997-01-07 | Quinton Instrument Company | Insertion assembly and method of inserting a vessel plug into the body of a patient |
US5645566A (en) * | 1995-09-15 | 1997-07-08 | Sub Q Inc. | Apparatus and method for percutaneous sealing of blood vessel punctures |
US5769882A (en) * | 1995-09-08 | 1998-06-23 | Medtronic, Inc. | Methods and apparatus for conformably sealing prostheses within body lumens |
US5795331A (en) * | 1994-01-24 | 1998-08-18 | Micro Therapeutics, Inc. | Balloon catheter for occluding aneurysms of branch vessels |
US5843160A (en) * | 1996-04-01 | 1998-12-01 | Rhodes; Valentine J. | Prostheses for aneurysmal and/or occlusive disease at a bifurcation in a vessel, duct, or lumen |
US6126675A (en) * | 1999-01-11 | 2000-10-03 | Ethicon, Inc. | Bioabsorbable device and method for sealing vascular punctures |
US6299597B1 (en) * | 1993-09-16 | 2001-10-09 | Scimed Life Systems, Inc. | Percutaneous repair of cardiovascular anomalies and repair compositions |
US6371974B1 (en) * | 1995-09-15 | 2002-04-16 | Sub Q, Inc. | Apparatus and method for percutaneous sealing of blood vessel punctures |
US6379329B1 (en) * | 1999-06-02 | 2002-04-30 | Cordis Neurovascular, Inc. | Detachable balloon embolization device and method |
US6475182B1 (en) * | 1997-03-12 | 2002-11-05 | Olexander Hnojewyj | Fluidic media introduction apparatus |
US6551344B2 (en) * | 2000-04-26 | 2003-04-22 | Ev3 Inc. | Septal defect occluder |
US20030208232A1 (en) * | 2002-05-06 | 2003-11-06 | Velocimed, L.L.C. | PFO closure devices and related methods of use |
US6726696B1 (en) * | 2001-04-24 | 2004-04-27 | Advanced Catheter Engineering, Inc. | Patches and collars for medical applications and methods of use |
US6743241B2 (en) * | 2002-03-01 | 2004-06-01 | Intellimed Surgical Solutions Llc | Laparoscopic port site fascial closure device |
US20050034735A1 (en) * | 2003-03-27 | 2005-02-17 | Cierra, Inc. | Methods and apparatus for treatment of patent foramen ovale |
US6955661B1 (en) * | 1999-01-25 | 2005-10-18 | Atrium Medical Corporation | Expandable fluoropolymer device for delivery of therapeutic agents and method of making |
US7025776B1 (en) * | 2001-04-24 | 2006-04-11 | Advanced Catheter Engineering, Inc. | Arteriotomy closure devices and techniques |
US7632291B2 (en) * | 2003-06-13 | 2009-12-15 | Trivascular2, Inc. | Inflatable implant |
Family Cites Families (271)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3077733A (en) | 1959-08-17 | 1963-02-19 | Phillips Petroleum Co | Method of making jet fuel and use thereof |
US3874388A (en) | 1973-02-12 | 1975-04-01 | Ochsner Med Found Alton | Shunt defect closure system |
US4007743A (en) | 1975-10-20 | 1977-02-15 | American Hospital Supply Corporation | Opening mechanism for umbrella-like intravascular shunt defect closure device |
US4394864A (en) | 1981-04-15 | 1983-07-26 | Jeffrey Sandhaus | Apparatus and method for effecting occlusion of the vas deferens |
US4515583A (en) | 1983-10-17 | 1985-05-07 | Coopervision, Inc. | Operative elliptical probe for ultrasonic surgical instrument and method of its use |
DE3447642C1 (en) | 1984-12-28 | 1986-09-18 | Bernhard M. Dr. 5600 Wuppertal Cramer | Steerable guidewire for catheters |
WO1988005316A1 (en) | 1987-01-13 | 1988-07-28 | Terumo Kabushiki Kaisha | Balloon catheter and production thereof |
US5025799A (en) | 1987-05-13 | 1991-06-25 | Wilson Bruce C | Steerable memory alloy guide wires |
US5478353A (en) | 1987-05-14 | 1995-12-26 | Yoon; Inbae | Suture tie device system and method for suturing anatomical tissue proximate an opening |
US4836204A (en) | 1987-07-06 | 1989-06-06 | Landymore Roderick W | Method for effecting closure of a perforation in the septum of the heart |
US4841988A (en) | 1987-10-15 | 1989-06-27 | Marquette Electronics, Inc. | Microwave hyperthermia probe |
DE3825631A1 (en) | 1988-07-28 | 1990-02-08 | Osypka Peter | DEVICE FOR TRANSVENOUS OR ARTERIAL INSERTION BY MEANS OF A GUIDE WIRE |
US4967765A (en) | 1988-07-28 | 1990-11-06 | Bsd Medical Corporation | Urethral inserted applicator for prostate hyperthermia |
US4946440A (en) * | 1988-10-05 | 1990-08-07 | Hall John E | Evertible membrane catheter and method of use |
US4945912A (en) | 1988-11-25 | 1990-08-07 | Sensor Electronics, Inc. | Catheter with radiofrequency heating applicator |
FR2641692A1 (en) | 1989-01-17 | 1990-07-20 | Nippon Zeon Co | Plug for closing an opening for a medical application, and device for the closure plug making use thereof |
US5486185A (en) | 1989-01-30 | 1996-01-23 | Dexide, Inc. | Surgical apparatus |
US5073166A (en) | 1989-02-15 | 1991-12-17 | Medical Innovations Corporation | Method and apparatus for emplacement of a gastrostomy catheter |
US5100429A (en) * | 1989-04-28 | 1992-03-31 | C. R. Bard, Inc. | Endovascular stent and delivery system |
US5620461A (en) | 1989-05-29 | 1997-04-15 | Muijs Van De Moer; Wouter M. | Sealing device |
US4985014A (en) | 1989-07-11 | 1991-01-15 | Orejola Wilmo C | Ventricular venting loop |
US5007908A (en) | 1989-09-29 | 1991-04-16 | Everest Medical Corporation | Electrosurgical instrument having needle cutting electrode and spot-coag electrode |
US5797907A (en) | 1989-11-06 | 1998-08-25 | Mectra Labs, Inc. | Electrocautery cutter |
US5030199A (en) | 1989-12-11 | 1991-07-09 | Medical Engineering Corporation | Female incontinence control device with magnetically operable valve and method |
US5049153A (en) | 1989-12-26 | 1991-09-17 | Nakao Naomi L | Endoscopic stapling device and method |
US5851206A (en) * | 1990-03-13 | 1998-12-22 | The Regents Of The University Of California | Method and apparatus for endovascular thermal thrombosis and thermal cancer treatment |
WO1991015155A1 (en) | 1990-04-02 | 1991-10-17 | Kanji Inoue | Device for closing shunt opening by nonoperative method |
US5021059A (en) | 1990-05-07 | 1991-06-04 | Kensey Nash Corporation | Plug device with pulley for sealing punctures in tissue and methods of use |
US5041129A (en) | 1990-07-02 | 1991-08-20 | Acufex Microsurgical, Inc. | Slotted suture anchor and method of anchoring a suture |
US5057114A (en) | 1990-09-18 | 1991-10-15 | Cook Incorporated | Medical retrieval basket |
ES2241527T3 (en) | 1990-10-09 | 2005-11-01 | Medtronic, Inc. | MATERIAL HANDLING DEVICE. |
US5190528A (en) | 1990-10-19 | 1993-03-02 | Boston University | Percutaneous transseptal left atrial cannulation system |
US5108420A (en) | 1991-02-01 | 1992-04-28 | Temple University | Aperture occlusion device |
US5112310A (en) | 1991-02-06 | 1992-05-12 | Grobe James L | Apparatus and methods for percutaneous endoscopic gastrostomy |
US5690675A (en) | 1991-02-13 | 1997-11-25 | Fusion Medical Technologies, Inc. | Methods for sealing of staples and other fasteners in tissue |
US5156613A (en) | 1991-02-13 | 1992-10-20 | Interface Biomedical Laboratories Corp. | Collagen welding rod material for use in tissue welding |
US5669934A (en) | 1991-02-13 | 1997-09-23 | Fusion Medical Technologies, Inc. | Methods for joining tissue by applying radiofrequency energy to performed collagen films and sheets |
US5584803A (en) | 1991-07-16 | 1996-12-17 | Heartport, Inc. | System for cardiac procedures |
US6730081B1 (en) | 1991-10-18 | 2004-05-04 | Ashvin H. Desai | Endoscopic surgical instrument |
US5364345A (en) * | 1991-10-18 | 1994-11-15 | Imagyn Medical, Inc. | Method of tubal recanalization and catheter system therefor |
DE69229539T2 (en) | 1991-11-05 | 2000-02-17 | Childrens Medical Center | Occlusion device for repairing heart and vascular defects |
EP0541063B1 (en) | 1991-11-05 | 1998-09-02 | The Children's Medical Center Corporation | Improved occluder for repair of cardiac and vascular defects |
US5282827A (en) | 1991-11-08 | 1994-02-01 | Kensey Nash Corporation | Hemostatic puncture closure system and method of use |
US5222974A (en) | 1991-11-08 | 1993-06-29 | Kensey Nash Corporation | Hemostatic puncture closure system and method of use |
US5522873A (en) | 1991-12-26 | 1996-06-04 | Webster Laboratories, Inc. | Catheter having electrode with annular recess and method of using same |
US5217435A (en) | 1992-01-07 | 1993-06-08 | Kring Robert S | Cardiac catheter apparatus |
EP0623003B1 (en) | 1992-01-21 | 1999-03-31 | Regents Of The University Of Minnesota | Septal defect closure device |
IL100721A (en) | 1992-01-21 | 1996-12-05 | Milo Simcha | Punch for opening passages between two compartments |
US5649950A (en) | 1992-01-22 | 1997-07-22 | C. R. Bard | System for the percutaneous transluminal front-end loading delivery and retrieval of a prosthetic occluder |
US5540681A (en) | 1992-04-10 | 1996-07-30 | Medtronic Cardiorhythm | Method and system for radiofrequency ablation of tissue |
US5573533A (en) | 1992-04-10 | 1996-11-12 | Medtronic Cardiorhythm | Method and system for radiofrequency ablation of cardiac tissue |
US5810810A (en) | 1992-04-23 | 1998-09-22 | Scimed Life Systems, Inc. | Apparatus and method for sealing vascular punctures |
WO1993021844A1 (en) | 1992-04-23 | 1993-11-11 | Scimed Life Systems, Inc. | Apparatus and method for sealing vascular punctures |
US6063085A (en) | 1992-04-23 | 2000-05-16 | Scimed Life Systems, Inc. | Apparatus and method for sealing vascular punctures |
US5540712A (en) | 1992-05-01 | 1996-07-30 | Nitinol Medical Technologies, Inc. | Stent and method and apparatus for forming and delivering the same |
US5336252A (en) | 1992-06-22 | 1994-08-09 | Cohen Donald M | System and method for implanting cardiac electrical leads |
AU682003B2 (en) | 1992-06-26 | 1997-09-18 | Schneider (Usa) Inc. | Catheter with expandable wire mesh tip |
US5312341A (en) | 1992-08-14 | 1994-05-17 | Wayne State University | Retaining apparatus and procedure for transseptal catheterization |
US6086581A (en) | 1992-09-29 | 2000-07-11 | Ep Technologies, Inc. | Large surface cardiac ablation catheter that assumes a low profile during introduction into the heart |
US5304185A (en) | 1992-11-04 | 1994-04-19 | Unisurge, Inc. | Needle holder |
US5620479A (en) | 1992-11-13 | 1997-04-15 | The Regents Of The University Of California | Method and apparatus for thermal therapy of tumors |
US5357979A (en) | 1992-12-01 | 1994-10-25 | Intelliwire, Inc. | Flexible elongate device having a distal extremity with current controlled adjustable stiffness and adjustable bend location and method |
US5284488A (en) | 1992-12-23 | 1994-02-08 | Sideris Eleftherios B | Adjustable devices for the occlusion of cardiac defects |
US5797960A (en) | 1993-02-22 | 1998-08-25 | Stevens; John H. | Method and apparatus for thoracoscopic intracardiac procedures |
US6346074B1 (en) | 1993-02-22 | 2002-02-12 | Heartport, Inc. | Devices for less invasive intracardiac interventions |
US5636634A (en) * | 1993-03-16 | 1997-06-10 | Ep Technologies, Inc. | Systems using guide sheaths for introducing, deploying, and stabilizing cardiac mapping and ablation probes |
US5312435A (en) | 1993-05-17 | 1994-05-17 | Kensey Nash Corporation | Fail predictable, reinforced anchor for hemostatic puncture closure |
US5630837A (en) | 1993-07-01 | 1997-05-20 | Boston Scientific Corporation | Acoustic ablation |
US5385156A (en) * | 1993-08-27 | 1995-01-31 | Rose Health Care Systems | Diagnostic and treatment method for cardiac rupture and apparatus for performing the same |
JP3185906B2 (en) | 1993-11-26 | 2001-07-11 | ニプロ株式会社 | Prosthesis for atrial septal defect |
US5545138A (en) | 1994-02-28 | 1996-08-13 | Medtronic, Inc. | Adjustable stiffness dilatation catheter |
JPH07265329A (en) | 1994-03-31 | 1995-10-17 | Fuji Photo Optical Co Ltd | Puncture high frequency treatment device |
AU2255195A (en) | 1994-04-06 | 1995-10-30 | William Cook Europe A/S | A medical article for implantation into the vascular system of a patient |
US5484385A (en) | 1994-04-21 | 1996-01-16 | C. R. Bard, Inc. | Intra-aortic balloon catheter |
US5680860A (en) * | 1994-07-07 | 1997-10-28 | Cardiac Pathways Corporation | Mapping and/or ablation catheter with coilable distal extremity and method for using same |
US5725552A (en) | 1994-07-08 | 1998-03-10 | Aga Medical Corporation | Percutaneous catheter directed intravascular occlusion devices |
US5797905A (en) | 1994-08-08 | 1998-08-25 | E. P. Technologies Inc. | Flexible tissue ablation elements for making long lesions |
US5433727A (en) | 1994-08-16 | 1995-07-18 | Sideris; Eleftherios B. | Centering buttoned device for the occlusion of large defects for occluding |
US5577299A (en) | 1994-08-26 | 1996-11-26 | Thompson; Carl W. | Quick-release mechanical knot apparatus |
US5601575A (en) | 1994-09-02 | 1997-02-11 | Ethicon Endo-Surgery, Inc. | Needle driving device |
US6558375B1 (en) | 2000-07-14 | 2003-05-06 | Cardiofocus, Inc. | Cardiac ablation instrument |
US6676656B2 (en) | 1994-09-09 | 2004-01-13 | Cardiofocus, Inc. | Surgical ablation with radiant energy |
DE4440346A1 (en) | 1994-11-13 | 1996-05-15 | Daum Gmbh | Puncture instrument |
US6171329B1 (en) | 1994-12-19 | 2001-01-09 | Gore Enterprise Holdings, Inc. | Self-expanding defect closure device and method of making and using |
US5879366A (en) | 1996-12-20 | 1999-03-09 | W.L. Gore & Associates, Inc. | Self-expanding defect closure device and method of making and using |
US5713908A (en) | 1995-01-09 | 1998-02-03 | Jameel; Irfan Mufty | Laparascopic suturing instrument |
US5702421A (en) | 1995-01-11 | 1997-12-30 | Schneidt; Bernhard | Closure device for closing a vascular opening, such as patent ductus arteriosus |
US5634936A (en) | 1995-02-06 | 1997-06-03 | Scimed Life Systems, Inc. | Device for closing a septal defect |
US5676662A (en) * | 1995-03-17 | 1997-10-14 | Daig Corporation | Ablation catheter |
US5626607A (en) | 1995-04-03 | 1997-05-06 | Heartport, Inc. | Clamp assembly and method of use |
WO1996034567A1 (en) | 1995-05-02 | 1996-11-07 | Heart Rhythm Technologies, Inc. | System for controlling the energy delivered to a patient for ablation |
EP1462065B1 (en) | 1995-05-04 | 2007-01-31 | Sherwood Services AG | Cool-tip electrode thermosurgery system |
US6461378B1 (en) | 1995-05-05 | 2002-10-08 | Thermage, Inc. | Apparatus for smoothing contour irregularities of skin surface |
US6241753B1 (en) | 1995-05-05 | 2001-06-05 | Thermage, Inc. | Method for scar collagen formation and contraction |
US6322548B1 (en) | 1995-05-10 | 2001-11-27 | Eclipse Surgical Technologies | Delivery catheter system for heart chamber |
US5827216A (en) | 1995-06-07 | 1998-10-27 | Cormedics Corp. | Method and apparatus for accessing the pericardial space |
US6132438A (en) | 1995-06-07 | 2000-10-17 | Ep Technologies, Inc. | Devices for installing stasis reducing means in body tissue |
DE69625549T2 (en) | 1995-06-27 | 2003-05-15 | Kao Corp | Plaster with a water-soluble adhesive layer |
US6023638A (en) | 1995-07-28 | 2000-02-08 | Scimed Life Systems, Inc. | System and method for conducting electrophysiological testing using high-voltage energy pulses to stun tissue |
US5836311A (en) | 1995-09-20 | 1998-11-17 | Medtronic, Inc. | Method and apparatus for temporarily immobilizing a local area of tissue |
WO1997013461A1 (en) | 1995-10-11 | 1997-04-17 | Fusion Medical Technologies, Inc. | Device and method for sealing tissue |
ATE275880T1 (en) | 1995-10-13 | 2004-10-15 | Transvascular Inc | DEVICE FOR BYPASSING ARTERIAL Narrowings AND/OR FOR PERFORMING OTHER TRANSVASCULAR PROCEDURES |
WO1997016119A1 (en) | 1995-10-30 | 1997-05-09 | Children's Medical Center Corporation | Self-centering umbrella-type septal closure device |
US5868753A (en) | 1995-11-13 | 1999-02-09 | Schatz; Richard A. | Stent retrieval catheter |
US6805130B2 (en) | 1995-11-22 | 2004-10-19 | Arthrocare Corporation | Methods for electrosurgical tendon vascularization |
DE19604817C2 (en) | 1996-02-09 | 2003-06-12 | Pfm Prod Fuer Die Med Ag | Device for closing defect openings in the human or animal body |
US5733294A (en) | 1996-02-28 | 1998-03-31 | B. Braun Medical, Inc. | Self expanding cardiovascular occlusion device, method of using and method of making the same |
US6139527A (en) | 1996-03-05 | 2000-10-31 | Vnus Medical Technologies, Inc. | Method and apparatus for treating hemorrhoids |
US5800478A (en) | 1996-03-07 | 1998-09-01 | Light Sciences Limited Partnership | Flexible microcircuits for internal light therapy |
US5853422A (en) | 1996-03-22 | 1998-12-29 | Scimed Life Systems, Inc. | Apparatus and method for closing a septal defect |
US6152918A (en) | 1996-04-05 | 2000-11-28 | Eclipse Surgical Technologies, Inc. | Laser device with auto-piercing tip for myocardial revascularization procedures |
AR001590A1 (en) | 1996-04-10 | 1997-11-26 | Jorge Alberto Baccaro | Abnormal vascular communications occluder device and applicator cartridge of said device |
US6813520B2 (en) | 1996-04-12 | 2004-11-02 | Novacept | Method for ablating and/or coagulating tissue using moisture transport |
WO1997041778A1 (en) | 1996-05-08 | 1997-11-13 | Salviac Limited | An occluder device |
US6488706B1 (en) | 1996-05-08 | 2002-12-03 | Carag Ag | Device for plugging an opening such as in a wall of a hollow or tubular organ |
US5800428A (en) | 1996-05-16 | 1998-09-01 | Angeion Corporation | Linear catheter ablation system |
US6743197B1 (en) | 1996-07-10 | 2004-06-01 | Novasys Medical, Inc. | Treatment of discrete tissues in respiratory, urinary, circulatory, reproductive and digestive systems |
US5800516A (en) | 1996-08-08 | 1998-09-01 | Cordis Corporation | Deployable and retrievable shape memory stent/tube and method |
US6544260B1 (en) | 1996-08-20 | 2003-04-08 | Oratec Interventions, Inc. | Method for treating tissue in arthroscopic environment using precooling and apparatus for same |
US6482224B1 (en) | 1996-08-22 | 2002-11-19 | The Trustees Of Columbia University In The City Of New York | Endovascular flexible stapling device |
US5741297A (en) | 1996-08-28 | 1998-04-21 | Simon; Morris | Daisy occluder and method for septal defect repair |
US5810884A (en) | 1996-09-09 | 1998-09-22 | Beth Israel Deaconess Medical Center | Apparatus and method for closing a vascular perforation after percutaneous puncture of a blood vessel in a living subject |
US5741249A (en) | 1996-10-16 | 1998-04-21 | Fidus Medical Technology Corporation | Anchoring tip assembly for microwave ablation catheter |
US6086610A (en) | 1996-10-22 | 2000-07-11 | Nitinol Devices & Components | Composite self expanding stent device having a restraining element |
US5861003A (en) | 1996-10-23 | 1999-01-19 | The Cleveland Clinic Foundation | Apparatus and method for occluding a defect or aperture within body surface |
US5827268A (en) | 1996-10-30 | 1998-10-27 | Hearten Medical, Inc. | Device for the treatment of patent ductus arteriosus and method of using the device |
US6292700B1 (en) | 1999-09-10 | 2001-09-18 | Surx, Inc. | Endopelvic fascia treatment for incontinence |
US5954719A (en) | 1996-12-11 | 1999-09-21 | Irvine Biomedical, Inc. | System for operating a RF ablation generator |
US5807384A (en) | 1996-12-20 | 1998-09-15 | Eclipse Surgical Technologies, Inc. | Transmyocardial revascularization (TMR) enhanced treatment for coronary artery disease |
US6068630A (en) * | 1997-01-02 | 2000-05-30 | St. Francis Medical Technologies, Inc. | Spine distraction implant |
US5776162A (en) | 1997-01-03 | 1998-07-07 | Nitinol Medical Technologies, Inc. | Vessel implantable shape memory appliance with superelastic hinged joint |
JP3134288B2 (en) | 1997-01-30 | 2001-02-13 | 株式会社ニッショー | Endocardial suture surgery tool |
JP3134287B2 (en) | 1997-01-30 | 2001-02-13 | 株式会社ニッショー | Catheter assembly for endocardial suture surgery |
US6626901B1 (en) | 1997-03-05 | 2003-09-30 | The Trustees Of Columbia University In The City Of New York | Electrothermal instrument for sealing and joining or cutting tissue |
US5810867A (en) | 1997-04-28 | 1998-09-22 | Medtronic, Inc. | Dilatation catheter with varied stiffness |
US5849028A (en) | 1997-05-16 | 1998-12-15 | Irvine Biomedical, Inc. | Catheter and method for radiofrequency ablation of cardiac tissue |
US5997562A (en) | 1997-06-13 | 1999-12-07 | Percusurge, Inc. | Medical wire introducer and balloon protective sheath |
US5938660A (en) * | 1997-06-27 | 1999-08-17 | Daig Corporation | Process and device for the treatment of atrial arrhythmia |
US5957919A (en) | 1997-07-02 | 1999-09-28 | Laufer; Michael D. | Bleb reducer |
US6030007A (en) | 1997-07-07 | 2000-02-29 | Hughes Electronics Corporation | Continually adjustable nonreturn knot |
GB9900964D0 (en) | 1999-01-15 | 1999-03-10 | Gyrus Medical Ltd | An electrosurgical system |
US6096037A (en) | 1997-07-29 | 2000-08-01 | Medtronic, Inc. | Tissue sealing electrosurgery device and methods of sealing tissue |
AUPO820897A0 (en) | 1997-07-24 | 1997-08-14 | Cardiac Crc Nominees Pty Limited | An intraoperative endocardial and epicardial ablation probe |
US6174322B1 (en) | 1997-08-08 | 2001-01-16 | Cardia, Inc. | Occlusion device for the closure of a physical anomaly such as a vascular aperture or an aperture in a septum |
US5895404A (en) | 1997-09-29 | 1999-04-20 | Ruiz; Carlos E. | Apparatus and methods for percutaneously forming a passageway between adjacent vessels or portions of a vessel |
US6106520A (en) | 1997-09-30 | 2000-08-22 | Hearten Medical, Inc. | Endocardial device for producing reversible damage to heart tissue |
US6494881B1 (en) | 1997-09-30 | 2002-12-17 | Scimed Life Systems, Inc. | Apparatus and method for electrode-surgical tissue removal having a selectively insulated electrode |
US5976174A (en) | 1997-12-15 | 1999-11-02 | Ruiz; Carlos E. | Medical hole closure device and methods of use |
US6129755A (en) | 1998-01-09 | 2000-10-10 | Nitinol Development Corporation | Intravascular stent having an improved strut configuration |
US5944738A (en) | 1998-02-06 | 1999-08-31 | Aga Medical Corporation | Percutaneous catheter directed constricting occlusion device |
US6325798B1 (en) | 1998-02-19 | 2001-12-04 | Curon Medical, Inc. | Vacuum-assisted systems and methods for treating sphincters and adjoining tissue regions |
US6659105B2 (en) | 1998-02-26 | 2003-12-09 | Senorx, Inc. | Tissue specimen isolating and damaging device and method |
JP3799810B2 (en) | 1998-03-30 | 2006-07-19 | ニプロ株式会社 | Transcatheter surgery closure plug and catheter assembly |
US6241740B1 (en) | 1998-04-09 | 2001-06-05 | Origin Medsystems, Inc. | System and method of use for ligating and cutting tissue |
US5993475A (en) | 1998-04-22 | 1999-11-30 | Bristol-Myers Squibb Co. | Tissue repair device |
US6332877B1 (en) | 1998-05-12 | 2001-12-25 | Novartis Ag | Ostomy tube placement tip |
US6527767B2 (en) | 1998-05-20 | 2003-03-04 | New England Medical Center | Cardiac ablation system and method for treatment of cardiac arrhythmias and transmyocardial revascularization |
US6113609A (en) | 1998-05-26 | 2000-09-05 | Scimed Life Systems, Inc. | Implantable tissue fastener and system for treating gastroesophageal reflux disease |
US6607541B1 (en) | 1998-06-03 | 2003-08-19 | Coalescent Surgical, Inc. | Tissue connector apparatus and methods |
US6599302B2 (en) | 1998-06-10 | 2003-07-29 | Converge Medical, Inc. | Aortic aneurysm treatment systems |
US6302903B1 (en) | 1998-07-07 | 2001-10-16 | Medtronic, Inc. | Straight needle apparatus for creating a virtual electrode used for the ablation of tissue |
US6165183A (en) | 1998-07-15 | 2000-12-26 | St. Jude Medical, Inc. | Mitral and tricuspid valve repair |
US6461327B1 (en) | 1998-08-07 | 2002-10-08 | Embol-X, Inc. | Atrial isolator and method of use |
US6254550B1 (en) | 1998-08-19 | 2001-07-03 | Cook Incorporated | Preformed wire guide |
US6149664A (en) | 1998-08-27 | 2000-11-21 | Micrus Corporation | Shape memory pusher introducer for vasoocclusive devices |
US6016811A (en) | 1998-09-01 | 2000-01-25 | Fidus Medical Technology Corporation | Method of using a microwave ablation catheter with a loop configuration |
US6251128B1 (en) | 1998-09-01 | 2001-06-26 | Fidus Medical Technology Corporation | Microwave ablation catheter with loop configuration |
MXPA01002686A (en) | 1998-09-15 | 2002-06-04 | Medtronic Inc | Method and apparatus for temporarily immobilizing a local area of tissue. |
US6007558A (en) | 1998-09-25 | 1999-12-28 | Nitinol Medical Technologies, Inc. | Removable embolus blood clot filter |
US6735532B2 (en) | 1998-09-30 | 2004-05-11 | L. Vad Technology, Inc. | Cardiovascular support control system |
US6283935B1 (en) | 1998-09-30 | 2001-09-04 | Hearten Medical | Ultrasonic device for providing reversible tissue damage to heart muscle |
US5919200A (en) | 1998-10-09 | 1999-07-06 | Hearten Medical, Inc. | Balloon catheter for abrading a patent foramen ovale and method of using the balloon catheter |
US6796981B2 (en) | 1999-09-30 | 2004-09-28 | Sherwood Services Ag | Vessel sealing system |
US6245062B1 (en) | 1998-10-23 | 2001-06-12 | Afx, Inc. | Directional reflector shield assembly for a microwave ablation instrument |
US6398779B1 (en) | 1998-10-23 | 2002-06-04 | Sherwood Services Ag | Vessel sealing system |
US6162202A (en) | 1998-10-26 | 2000-12-19 | Sicurelli; Robert | Flexible syringe needle |
US6123718A (en) | 1998-11-02 | 2000-09-26 | Polymerex Medical Corp. | Balloon catheter |
US6701176B1 (en) | 1998-11-04 | 2004-03-02 | Johns Hopkins University School Of Medicine | Magnetic-resonance-guided imaging, electrophysiology, and ablation |
US7713282B2 (en) | 1998-11-06 | 2010-05-11 | Atritech, Inc. | Detachable atrial appendage occlusion balloon |
US7044134B2 (en) | 1999-11-08 | 2006-05-16 | Ev3 Sunnyvale, Inc | Method of implanting a device in the left atrial appendage |
US6152144A (en) | 1998-11-06 | 2000-11-28 | Appriva Medical, Inc. | Method and device for left atrial appendage occlusion |
JP3906475B2 (en) | 1998-12-22 | 2007-04-18 | ニプロ株式会社 | Transcatheter surgery closure plug and catheter assembly |
US6142975A (en) | 1998-12-31 | 2000-11-07 | Advanced Cardiovascular Systems, Inc. | Guidewire having braided wire over drawn tube construction |
US6206921B1 (en) | 1999-02-22 | 2001-03-27 | Peter A. Guagliano | Method of replacing nucleus pulposus and repairing the intervertebral disk |
US6338731B1 (en) | 1999-03-17 | 2002-01-15 | Ntero Surgical, Inc. | Method and systems for reducing surgical complications |
US6432119B1 (en) | 1999-03-17 | 2002-08-13 | Angiotrax, Inc. | Apparatus and methods for performing percutaneous myocardial revascularization and stimulating angiogenesis using autologous materials |
US6352531B1 (en) | 1999-03-24 | 2002-03-05 | Micrus Corporation | Variable stiffness optical fiber shaft |
US6702811B2 (en) * | 1999-04-05 | 2004-03-09 | Medtronic, Inc. | Ablation catheter assembly with radially decreasing helix and method of use |
JP2000300571A (en) | 1999-04-19 | 2000-10-31 | Nissho Corp | Closure plug for transcatheter operation |
US6206907B1 (en) | 1999-05-07 | 2001-03-27 | Cardia, Inc. | Occlusion device with stranded wire support arms |
US6712836B1 (en) | 1999-05-13 | 2004-03-30 | St. Jude Medical Atg, Inc. | Apparatus and methods for closing septal defects and occluding blood flow |
US6379368B1 (en) | 1999-05-13 | 2002-04-30 | Cardia, Inc. | Occlusion device with non-thrombogenic properties |
US6375635B1 (en) | 1999-05-18 | 2002-04-23 | Hydrocision, Inc. | Fluid jet surgical instruments |
US6616655B1 (en) | 1999-06-03 | 2003-09-09 | C. R. Bard, Inc. | Method and apparatus for performing cardiac ablations |
US6494888B1 (en) | 1999-06-22 | 2002-12-17 | Ndo Surgical, Inc. | Tissue reconfiguration |
US6290699B1 (en) | 1999-07-07 | 2001-09-18 | Uab Research Foundation | Ablation tool for forming lesions in body tissue |
US6364878B1 (en) | 1999-07-07 | 2002-04-02 | Cardiac Pacemakers, Inc. | Percutaneous transluminal ablation catheter manipulation tool |
US7892246B2 (en) | 1999-07-28 | 2011-02-22 | Bioconnect Systems, Inc. | Devices and methods for interconnecting conduits and closing openings in tissue |
US6235044B1 (en) | 1999-08-04 | 2001-05-22 | Scimed Life Systems, Inc. | Percutaneous catheter and guidewire for filtering during ablation of mycardial or vascular tissue |
US6632223B1 (en) * | 2000-03-30 | 2003-10-14 | The General Hospital Corporation | Pulmonary vein ablation stent and method |
US6231561B1 (en) | 1999-09-20 | 2001-05-15 | Appriva Medical, Inc. | Method and apparatus for closing a body lumen |
JP3909637B2 (en) * | 1999-09-28 | 2007-04-25 | 矢崎総業株式会社 | Crosshead |
US6551303B1 (en) | 1999-10-27 | 2003-04-22 | Atritech, Inc. | Barrier device for ostium of left atrial appendage |
WO2001035844A2 (en) | 1999-11-10 | 2001-05-25 | Novacept | System and method for detecting perforations in a body cavity |
US6387104B1 (en) | 1999-11-12 | 2002-05-14 | Scimed Life Systems, Inc. | Method and apparatus for endoscopic repair of the lower esophageal sphincter |
US6371971B1 (en) | 1999-11-15 | 2002-04-16 | Scimed Life Systems, Inc. | Guidewire filter and methods of use |
US7335426B2 (en) | 1999-11-19 | 2008-02-26 | Advanced Bio Prosthetic Surfaces, Ltd. | High strength vacuum deposited nitinol alloy films and method of making same |
US20010041914A1 (en) | 1999-11-22 | 2001-11-15 | Frazier Andrew G.C. | Tissue patch deployment catheter |
US6790218B2 (en) | 1999-12-23 | 2004-09-14 | Swaminathan Jayaraman | Occlusive coil manufacture and delivery |
DE10000137A1 (en) | 2000-01-04 | 2001-07-12 | Pfm Prod Fuer Die Med Ag | Implantate for closing defect apertures in human or animal bodies, bearing structure of which can be reversed from secondary to primary form by elastic force |
US6780197B2 (en) | 2000-01-05 | 2004-08-24 | Integrated Vascular Systems, Inc. | Apparatus and methods for delivering a vascular closure device to a body lumen |
ATE484757T1 (en) | 2000-02-01 | 2010-10-15 | Surgivision Inc | TRANSSEPTAL NEEDLE ANTENNA FOR AN MR IMAGING DEVICE |
US6558385B1 (en) | 2000-09-22 | 2003-05-06 | Tissuelink Medical, Inc. | Fluid-assisted medical device |
US6770070B1 (en) | 2000-03-17 | 2004-08-03 | Rita Medical Systems, Inc. | Lung treatment apparatus and method |
US6673068B1 (en) | 2000-04-12 | 2004-01-06 | Afx, Inc. | Electrode arrangement for use in a medical instrument |
US7056294B2 (en) | 2000-04-13 | 2006-06-06 | Ev3 Sunnyvale, Inc | Method and apparatus for accessing the left atrial appendage |
US6650923B1 (en) | 2000-04-13 | 2003-11-18 | Ev3 Sunnyvale, Inc. | Method for accessing the left atrium of the heart by locating the fossa ovalis |
JP3844661B2 (en) | 2000-04-19 | 2006-11-15 | ラディ・メディカル・システムズ・アクチェボラーグ | Intra-arterial embolus |
US6652517B1 (en) | 2000-04-25 | 2003-11-25 | Uab Research Foundation | Ablation catheter, system, and method of use thereof |
US6214029B1 (en) | 2000-04-26 | 2001-04-10 | Microvena Corporation | Septal defect occluder |
US6334864B1 (en) | 2000-05-17 | 2002-01-01 | Aga Medical Corp. | Alignment member for delivering a non-symmetric device with a predefined orientation |
US6440152B1 (en) | 2000-07-28 | 2002-08-27 | Microvena Corporation | Defect occluder release assembly and method |
US7387628B1 (en) * | 2000-09-15 | 2008-06-17 | Boston Scientific Scimed, Inc. | Methods and systems for focused bipolar tissue ablation |
WO2002024106A2 (en) | 2000-09-21 | 2002-03-28 | Atritech, Inc. | Apparatus for implanting devices in atrial appendages |
WO2002024114A2 (en) | 2000-09-25 | 2002-03-28 | Cohesion Technologies, Inc. | Resorbable anastomosis stents and plugs |
US6641579B1 (en) | 2000-09-29 | 2003-11-04 | Spectrasonics Imaging, Inc. | Apparatus and method for ablating cardiac tissue |
EP1349510A4 (en) | 2000-12-15 | 2005-07-13 | Tony R Brown | Atrial fibrillation rf treatment device and method |
US6746404B2 (en) | 2000-12-18 | 2004-06-08 | Biosense, Inc. | Method for anchoring a medical device between tissue |
US6622731B2 (en) * | 2001-01-11 | 2003-09-23 | Rita Medical Systems, Inc. | Bone-treatment instrument and method |
DE60238178D1 (en) | 2001-01-16 | 2010-12-16 | Cytyc Surgical Products Palo A | DEVICE AND METHOD FOR TREATING THE VENOUS REFLUX |
US20020128680A1 (en) | 2001-01-25 | 2002-09-12 | Pavlovic Jennifer L. | Distal protection device with electrospun polymer fiber matrix |
US20020107531A1 (en) | 2001-02-06 | 2002-08-08 | Schreck Stefan G. | Method and system for tissue repair using dual catheters |
US6692471B2 (en) | 2001-02-16 | 2004-02-17 | Medex, Inc. | Method and apparatus for safety catheter insertion device |
US6623518B2 (en) | 2001-02-26 | 2003-09-23 | Ev3 Peripheral, Inc. | Implant delivery system with interlock |
US6666863B2 (en) | 2001-03-01 | 2003-12-23 | Scimed Life Systems, Inc. | Device and method for percutaneous myocardial revascularization |
US6913579B2 (en) | 2001-05-01 | 2005-07-05 | Surgrx, Inc. | Electrosurgical working end and method for obtaining tissue samples for biopsy |
US6537300B2 (en) | 2001-05-30 | 2003-03-25 | Scimed Life Systems, Inc. | Implantable obstruction device for septal defects |
US7338514B2 (en) | 2001-06-01 | 2008-03-04 | St. Jude Medical, Cardiology Division, Inc. | Closure devices, related delivery methods and tools, and related methods of use |
US6755822B2 (en) | 2001-06-01 | 2004-06-29 | Cryocor, Inc. | Device and method for the creation of a circumferential cryogenic lesion in a pulmonary vein |
US7288105B2 (en) | 2001-08-01 | 2007-10-30 | Ev3 Endovascular, Inc. | Tissue opening occluder |
US6663592B2 (en) | 2001-09-06 | 2003-12-16 | Medex, Inc. | Catheter introducer assembly having safety shielded needle |
US6776784B2 (en) | 2001-09-06 | 2004-08-17 | Core Medical, Inc. | Clip apparatus for closing septal defects and methods of use |
US6702835B2 (en) | 2001-09-07 | 2004-03-09 | Core Medical, Inc. | Needle apparatus for closing septal defects and methods for using such apparatus |
US6802843B2 (en) | 2001-09-13 | 2004-10-12 | Csaba Truckai | Electrosurgical working end with resistive gradient electrodes |
US6596013B2 (en) | 2001-09-20 | 2003-07-22 | Scimed Life Systems, Inc. | Method and apparatus for treating septal defects |
US6652486B2 (en) | 2001-09-27 | 2003-11-25 | Medex, Inc. | Safety catheter |
US7344533B2 (en) | 2001-09-28 | 2008-03-18 | Angiodynamics, Inc. | Impedance controlled tissue ablation apparatus and method |
US6730062B2 (en) | 2001-10-11 | 2004-05-04 | Medex, Inc. | Safety catheter with non-removable retractable needle |
US6893431B2 (en) * | 2001-10-15 | 2005-05-17 | Scimed Life Systems, Inc. | Medical device for delivering patches |
US6878147B2 (en) | 2001-11-02 | 2005-04-12 | Vivant Medical, Inc. | High-strength microwave antenna assemblies |
US6602252B2 (en) | 2002-01-03 | 2003-08-05 | Starion Instruments Corporation | Combined dissecting, cauterizing, and stapling device |
JP2005525843A (en) | 2002-01-14 | 2005-09-02 | エヌエムティー メディカル インコーポレイテッド | Patent foramen ovale (PFO) occlusion method and apparatus |
US20030139819A1 (en) | 2002-01-18 | 2003-07-24 | Beer Nicholas De | Method and apparatus for closing septal defects |
US6764486B2 (en) | 2002-04-24 | 2004-07-20 | Biotronik Mess- und Therapieger{haeck over (a)}te GmbH & Co. Ingenieurbüro Berlin | Ablation device for cardiac tissue, especially for forming a circular lesion around a vessel orifice in the heart |
US6709432B2 (en) | 2002-04-26 | 2004-03-23 | Medtronic, Inc. | Ablation methods and medical apparatus using same |
US6780183B2 (en) | 2002-09-16 | 2004-08-24 | Biosense Webster, Inc. | Ablation catheter having shape-changing balloon |
ATE379991T1 (en) | 2002-09-23 | 2007-12-15 | Nmt Medical Inc | DEVICE FOR PUNCTURE A SEPTUM |
US7780700B2 (en) | 2003-02-04 | 2010-08-24 | ev3 Endovascular, Inc | Patent foramen ovale closure system |
US8021359B2 (en) | 2003-02-13 | 2011-09-20 | Coaptus Medical Corporation | Transseptal closure of a patent foramen ovale and other cardiac defects |
WO2004082532A1 (en) | 2003-03-17 | 2004-09-30 | Ev3 Sunnyvale, Inc. | Thin film composite lamination |
US7293562B2 (en) | 2003-03-27 | 2007-11-13 | Cierra, Inc. | Energy based devices and methods for treatment of anatomic tissue defects |
US6939348B2 (en) | 2003-03-27 | 2005-09-06 | Cierra, Inc. | Energy based devices and methods for treatment of patent foramen ovale |
US7186251B2 (en) | 2003-03-27 | 2007-03-06 | Cierra, Inc. | Energy based devices and methods for treatment of patent foramen ovale |
US20040267191A1 (en) | 2003-03-27 | 2004-12-30 | Cierra, Inc. | Methods and apparatus for treatment of patent foramen ovale |
US20040254572A1 (en) | 2003-04-25 | 2004-12-16 | Mcintyre Jon T. | Self anchoring radio frequency ablation array |
US7435248B2 (en) * | 2003-09-26 | 2008-10-14 | Boston Scientific Scimed, Inc. | Medical probes for creating and diagnosing circumferential lesions within or around the ostium of a vessel |
US20050187568A1 (en) * | 2004-02-20 | 2005-08-25 | Klenk Alan R. | Devices and methods for closing a patent foramen ovale with a coil-shaped closure device |
US20050288599A1 (en) | 2004-05-17 | 2005-12-29 | C.R. Bard, Inc. | High density atrial fibrillation cycle length (AFCL) detection and mapping system |
US7367975B2 (en) | 2004-06-21 | 2008-05-06 | Cierra, Inc. | Energy based devices and methods for treatment of anatomic tissue defects |
AU2006235506B2 (en) | 2005-04-11 | 2011-06-30 | Terumo Kabushiki Kaisha | Methods and apparatus to achieve a closure of a layered tissue defect |
US7797056B2 (en) * | 2005-09-06 | 2010-09-14 | Nmt Medical, Inc. | Removable intracardiac RF device |
-
2005
- 2005-01-27 WO PCT/US2005/002525 patent/WO2005074517A2/en active Application Filing
- 2005-01-27 JP JP2006551452A patent/JP2007519489A/en active Pending
- 2005-01-27 US US11/044,657 patent/US7988690B2/en not_active Expired - Fee Related
- 2005-01-27 CA CA002553869A patent/CA2553869A1/en not_active Abandoned
- 2005-01-27 JP JP2006551575A patent/JP2007519498A/en not_active Withdrawn
- 2005-01-27 CA CA002553940A patent/CA2553940A1/en not_active Abandoned
- 2005-01-27 EP EP05712119A patent/EP1715792A2/en not_active Withdrawn
- 2005-01-27 WO PCT/US2005/003126 patent/WO2005074814A2/en active Application Filing
- 2005-01-27 EP EP05712535A patent/EP1713401A2/en not_active Withdrawn
-
2011
- 2011-07-22 US US13/189,438 patent/US8348945B2/en not_active Expired - Fee Related
-
2012
- 2012-09-10 US US13/609,129 patent/US20130018414A1/en not_active Abandoned
- 2012-12-14 US US13/715,831 patent/US20130103034A1/en not_active Abandoned
Patent Citations (30)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4471779A (en) * | 1976-08-25 | 1984-09-18 | Becton, Dickinson And Company | Miniature balloon catheter |
US4364392A (en) * | 1980-12-04 | 1982-12-21 | Wisconsin Alumni Research Foundation | Detachable balloon catheter |
US5041090A (en) * | 1988-01-12 | 1991-08-20 | Scheglov Viktor I | Occluding device |
US5591205A (en) * | 1990-10-01 | 1997-01-07 | Quinton Instrument Company | Insertion assembly and method of inserting a vessel plug into the body of a patient |
US5213576A (en) * | 1991-06-11 | 1993-05-25 | Cordis Corporation | Therapeutic porous balloon catheter |
US5405472A (en) * | 1991-06-11 | 1995-04-11 | Cordis Corporation | Method of making infusion balloon catheter |
US5405360A (en) * | 1992-02-24 | 1995-04-11 | United States Surgical Corporation | Resilient arm mesh deployer |
US6299597B1 (en) * | 1993-09-16 | 2001-10-09 | Scimed Life Systems, Inc. | Percutaneous repair of cardiovascular anomalies and repair compositions |
US5795331A (en) * | 1994-01-24 | 1998-08-18 | Micro Therapeutics, Inc. | Balloon catheter for occluding aneurysms of branch vessels |
US5769882A (en) * | 1995-09-08 | 1998-06-23 | Medtronic, Inc. | Methods and apparatus for conformably sealing prostheses within body lumens |
US20040098097A1 (en) * | 1995-09-08 | 2004-05-20 | Fogarty Thomas J. | Methods and apparatus for conformably sealing prostheses within body lumens |
US6656214B1 (en) * | 1995-09-08 | 2003-12-02 | Medtronic Ave, Inc. | Methods and apparatus for conformably sealing prostheses within body lumens |
US5645566A (en) * | 1995-09-15 | 1997-07-08 | Sub Q Inc. | Apparatus and method for percutaneous sealing of blood vessel punctures |
US20020156495A1 (en) * | 1995-09-15 | 2002-10-24 | Rodney Brenneman | Apparatus and method for percutaneous sealing of blood vessel punctures |
US6371974B1 (en) * | 1995-09-15 | 2002-04-16 | Sub Q, Inc. | Apparatus and method for percutaneous sealing of blood vessel punctures |
US7175646B2 (en) * | 1995-09-15 | 2007-02-13 | Boston Scientific Scimed, Inc. | Apparatus and method for percutaneous sealing of blood vessel punctures |
US5843160A (en) * | 1996-04-01 | 1998-12-01 | Rhodes; Valentine J. | Prostheses for aneurysmal and/or occlusive disease at a bifurcation in a vessel, duct, or lumen |
US6475182B1 (en) * | 1997-03-12 | 2002-11-05 | Olexander Hnojewyj | Fluidic media introduction apparatus |
US6126675A (en) * | 1999-01-11 | 2000-10-03 | Ethicon, Inc. | Bioabsorbable device and method for sealing vascular punctures |
US6955661B1 (en) * | 1999-01-25 | 2005-10-18 | Atrium Medical Corporation | Expandable fluoropolymer device for delivery of therapeutic agents and method of making |
US6379329B1 (en) * | 1999-06-02 | 2002-04-30 | Cordis Neurovascular, Inc. | Detachable balloon embolization device and method |
US6551344B2 (en) * | 2000-04-26 | 2003-04-22 | Ev3 Inc. | Septal defect occluder |
US6726696B1 (en) * | 2001-04-24 | 2004-04-27 | Advanced Catheter Engineering, Inc. | Patches and collars for medical applications and methods of use |
US7025776B1 (en) * | 2001-04-24 | 2006-04-11 | Advanced Catheter Engineering, Inc. | Arteriotomy closure devices and techniques |
US6743241B2 (en) * | 2002-03-01 | 2004-06-01 | Intellimed Surgical Solutions Llc | Laparoscopic port site fascial closure device |
US20030208232A1 (en) * | 2002-05-06 | 2003-11-06 | Velocimed, L.L.C. | PFO closure devices and related methods of use |
US7976564B2 (en) * | 2002-05-06 | 2011-07-12 | St. Jude Medical, Cardiology Division, Inc. | PFO closure devices and related methods of use |
US20050034735A1 (en) * | 2003-03-27 | 2005-02-17 | Cierra, Inc. | Methods and apparatus for treatment of patent foramen ovale |
US7165552B2 (en) * | 2003-03-27 | 2007-01-23 | Cierra, Inc. | Methods and apparatus for treatment of patent foramen ovale |
US7632291B2 (en) * | 2003-06-13 | 2009-12-15 | Trivascular2, Inc. | Inflatable implant |
Cited By (34)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US9763658B2 (en) | 2002-08-02 | 2017-09-19 | Cedars-Sinai Medical Center | Methods and apparatus for atrioventricular valve repair |
US10499905B2 (en) | 2002-08-02 | 2019-12-10 | Cedars-Sinai Medical Center | Methods and apparatus for atrioventricular valve repair |
US20160192912A1 (en) * | 2007-01-23 | 2016-07-07 | Cvdevices, Llc | Devices, systems, and methods for atrial appendage occlusion using light cure |
US20160192911A1 (en) * | 2007-01-23 | 2016-07-07 | Cvdevices, Llc | Devices, systems, and hybrid methods for atrial appendage occlusion using light cure |
US11166703B2 (en) * | 2007-01-23 | 2021-11-09 | Cvdevices, Llc | Devices, systems, and methods for atrial appendage occlusion using light cure |
US11730591B2 (en) | 2013-03-07 | 2023-08-22 | Cedars-Sinai Medical | Method and apparatus for percutaneous delivery and deployment of a cardiovascular prosthesis |
US10080657B2 (en) | 2013-03-07 | 2018-09-25 | Cedars-Sinai Medical Center | Catheter based apical approach heart prostheses delivery system |
US10105221B2 (en) | 2013-03-07 | 2018-10-23 | Cedars-Sinai Medical Center | Method and apparatus for percutaneous delivery and deployment of a cardiovascular prosthesis |
US10898323B2 (en) | 2013-03-07 | 2021-01-26 | Cedars-Sinai Medical Center | Catheter based apical approach heart prostheses delivery system |
US11717303B2 (en) | 2013-03-13 | 2023-08-08 | Conformal Medical, Inc. | Devices and methods for excluding the left atrial appendage |
US11399842B2 (en) | 2013-03-13 | 2022-08-02 | Conformal Medical, Inc. | Devices and methods for excluding the left atrial appendage |
US10617425B2 (en) | 2014-03-10 | 2020-04-14 | Conformal Medical, Inc. | Devices and methods for excluding the left atrial appendage |
US10349948B2 (en) | 2014-03-31 | 2019-07-16 | Jitmed Sp. Z. O.O. | Left atrial appendage occlusion device |
US10799359B2 (en) | 2014-09-10 | 2020-10-13 | Cedars-Sinai Medical Center | Method and apparatus for percutaneous delivery and deployment of a cardiac valve prosthesis |
US10758265B2 (en) | 2014-11-14 | 2020-09-01 | Cedars-Sinai Medical Center | Cardiovascular access and device delivery system |
US11653948B2 (en) | 2014-11-14 | 2023-05-23 | Cedars-Sinai Medical Center | Cardiovascular access and device delivery system |
WO2016077783A1 (en) * | 2014-11-14 | 2016-05-19 | Cedars-Sinai Medical Center | Cardiovascular access and device delivery system |
US11241308B2 (en) | 2015-07-23 | 2022-02-08 | Cedars-Sinai Medical Center | Device for securing heart valve leaflets |
US11426172B2 (en) | 2016-10-27 | 2022-08-30 | Conformal Medical, Inc. | Devices and methods for excluding the left atrial appendage |
US11026695B2 (en) | 2016-10-27 | 2021-06-08 | Conformal Medical, Inc. | Devices and methods for excluding the left atrial appendage |
US11786256B2 (en) | 2016-10-27 | 2023-10-17 | Conformal Medical, Inc. | Devices and methods for excluding the left atrial appendage |
US11439501B2 (en) | 2017-01-25 | 2022-09-13 | Cedars-Sinai Medical Center | Device for securing heart valve leaflets |
US10918392B2 (en) | 2018-01-26 | 2021-02-16 | Syntheon 2.0, LLC | Left atrial appendage clipping device and methods for clipping the LAA |
US11712249B2 (en) | 2018-01-26 | 2023-08-01 | Syntheon 2.0, LLC | Left atrial appendage clipping device and methods for clipping the LAA |
US11191547B2 (en) | 2018-01-26 | 2021-12-07 | Syntheon 2.0, LLC | Left atrial appendage clipping device and methods for clipping the LAA |
US11291544B2 (en) | 2018-02-02 | 2022-04-05 | Cedars-Sinai Medical Center | Delivery platforms, devices, and methods for tricuspid valve repair |
WO2020010144A1 (en) * | 2018-07-03 | 2020-01-09 | Subramaniam Krishnan | Systems and methods for treating patent foramen ovale |
CN111528951A (en) * | 2019-02-06 | 2020-08-14 | 德普伊新特斯产品公司 | Adhesive cover occlusion device for aneurysm treatment |
US11116510B2 (en) | 2019-02-08 | 2021-09-14 | Conformal Medical, Inc. | Devices and methods for excluding the left atrial appendage |
US10722240B1 (en) | 2019-02-08 | 2020-07-28 | Conformal Medical, Inc. | Devices and methods for excluding the left atrial appendage |
US10925615B2 (en) | 2019-05-03 | 2021-02-23 | Syntheon 2.0, LLC | Recapturable left atrial appendage clipping device and methods for recapturing a left atrial appendage clip |
WO2021220223A1 (en) * | 2020-04-30 | 2021-11-04 | Ethicon, Inc. | Systems and methods for sealing cored or punctured tissue using inflatable balloon |
US20210361269A1 (en) * | 2020-05-21 | 2021-11-25 | St. Jude Medical, Cardiology Division, Inc. | Biomaterial occluder delivery mechanism |
US11883014B2 (en) * | 2020-05-21 | 2024-01-30 | St. Jude Medical, Cardiology Division, Inc. | Biomaterial occluder delivery mechanism |
Also Published As
Publication number | Publication date |
---|---|
EP1713401A2 (en) | 2006-10-25 |
US8348945B2 (en) | 2013-01-08 |
WO2005074517A3 (en) | 2005-09-22 |
JP2007519489A (en) | 2007-07-19 |
CA2553940A1 (en) | 2005-08-18 |
WO2005074517B1 (en) | 2005-10-20 |
US20130103034A1 (en) | 2013-04-25 |
US20110282345A1 (en) | 2011-11-17 |
WO2005074814A8 (en) | 2008-05-15 |
WO2005074814A3 (en) | 2005-12-08 |
WO2005074814A2 (en) | 2005-08-18 |
WO2005074517A8 (en) | 2005-11-10 |
US7988690B2 (en) | 2011-08-02 |
US20050192654A1 (en) | 2005-09-01 |
EP1715792A2 (en) | 2006-11-02 |
WO2005074517A2 (en) | 2005-08-18 |
JP2007519498A (en) | 2007-07-19 |
CA2553869A1 (en) | 2005-08-18 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
US8361111B2 (en) | Devices, systems and methods for closure of cardiac openings | |
US20130018414A1 (en) | Devices, Systems and Methods for Closure of Cardiac Openings | |
US8834519B2 (en) | Method and device for left atrial appendage occlusion | |
US10307253B2 (en) | System for improving cardiac function by sealing a partitioning membrane within a ventricle | |
JP4746872B2 (en) | PFO closure device and method related to use | |
CA2617949C (en) | Method for treating myocardial rupture | |
US6152144A (en) | Method and device for left atrial appendage occlusion | |
EP2416736B1 (en) | Sealing and filling ventricular partitioning devices to improve cardiac function | |
US20170100112A1 (en) | System for left atrial appendage occlusion | |
US10307147B2 (en) | System for improving cardiac function by sealing a partitioning membrane within a ventricle |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
STCB | Information on status: application discontinuation |
Free format text: ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION |