Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/10—Balloon catheters
  • A61M25/1011—Multiple balloon catheters
• • 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
  • A61B17/12027—Type of occlusion
  • A61B17/1204—Type of occlusion temporary occlusion
• • 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
  • 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
  • A61B2017/00831—Material properties
  • A61B2017/00876—Material properties magnetic
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
  • A61B90/08—Accessories or related features not otherwise provided for
  • A61B2090/0807—Indication means
  • A61B2090/0809—Indication of cracks or breakages
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
  • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
  • A61B2090/3966—Radiopaque markers visible in an X-ray image
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/10—Balloon catheters
  • A61M2025/1043—Balloon catheters with special features or adapted for special applications
  • A61M2025/1052—Balloon catheters with special features or adapted for special applications for temporarily occluding a vessel for isolating a sector
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2210/00—Anatomical parts of the body
  • A61M2210/12—Blood circulatory system
  • A61M2210/125—Heart

Definitions

• the present invention relates generally to apparatuses and methods for treating and preventing bleeding arising from the left atrial appendage using catheters having inflatable catheter balloons, at the pre-hemorrhage and post-hemorrhage stages.
• the left atrial appendage is a small, conical, ear-shaped muscular pouch projecting from the upper anterior portion of the left atrium of the heart.
• the LAA lies within the pericardial cavity, and is an extension of the left atrium.
• the LAA functions as a decompression chamber during left ventricular systole and during periods when left atrial pressure is high.
• the LAA is also commonly known as the left auricular appendix, the auricular, or the left auricle.
• the left atrium receives oxygenated blood from the lungs by way of the pulmonary veins, and pumps the oxygenated blood into the left ventricle via the mitral valve.
• the LAA has become the target of several invasive procedures due to the high likelihood of embolic strokes arising from the LAA. During these procedures, bleeding arising from the LAA can occur. Additionally during these procedures, there can be tearing of the LAA. It is also anticipated that in the next few years, the number of invasive procedures involving the LAA is going to rise significantly. Invasive procedures of the heart targeting or involving the LAA is especially expected in patients who have atrial fibrillation (AF) and who may be at an increased risk of stroke arising from the LAA.
• AF atrial fibrillation
• AF causes rapid randomized contractions of the atrial myocardium, resulting in an irregular and rapid ventricular rate and is currently, the most common type of cardiac arrhythmia. It affects more than 3 million patients in the United States, and this number is expected to climb to 16 million by 2050. AF is the most common cause of strokes arising from the heart due a blood clot forming in the heart.
• Embolic stroke interrupts blood flow to the brain, thereby causing the affected brain cells to die.
• brain cells die, the abilities controlled by the dying brain cells are compromised and eventually lost.
• stroke is the third leading cause of death, killing approximately 160,000 Americans each year. Additionally, stroke is the leading cause of adult disability and there are currently over four million Americans living with the effects of stroke.
• AF patients have a five-fold increased risk of an embolic stroke resulting primarily from thromboembolic events.
• the stroke-causing thrombus originates almost exclusively from the LAA.
• the thrombus formed in the LAA break away from the LAA and accumulates in other blood vessels, thereby blocking blood flow in these blood vessels, and ultimately leading to an embolic stroke.
• the occlusion, stapling or ligation of the LAA is believed to be an effective stroke prevention technique.
• Several existing medical procedures aim to prevent the migration of thrombus from the LAA.
• warfarin is a therapeutic drug classified as an anticoagulant that helps prevent thromboembolism.
• An anticoagulant drug is a drug that suppresses, delays, or nullifies blood coagulation.
• Warfarin has the chemical name, 4-hydroxy-3-oxo-l-phenylbutyl-2H-benzopyran-2-one, and molecular formula, C 1 9H 16 0 4 .
• a major drawback of warfarin is the difficulty of maintaining its therapeutic range, and thus, warfarin-administered patients require frequent monitoring and dose adjustments.
• occlusion of the LAA is believed to decrease the risk of an embolic stroke in non-valvular AF patients.
• Occlusion of the LAA is an obstruction or a closure of the LAA.
• the thrombus formed in the LAA are unable to migrate to other blood vessels, thereby reducing the risks of thromboembolism and embolic stroke.
• the occlusion of the LAA is believed to be an effective stroke prevention strategy in non-valvular AF patients. Indeed, this concept of occluding the LAA as a stroke prevention strategy is being increasingly tested with implantable medical devices that occlude the LAA.
• the WATCHMAN device developed by Atritech Inc. (Plymouth, Minnesota) is an implantable medical device designed to occlude the LAA in non-valvular AF patients.
• the WATCHMAN device is placed distal to the ostium of the LAA, thereby occluding the LAA.
• the occlusion of the LAA prevents the migration of the thrombus formed in the LAA, thereby reducing the risks of thromboembolism and embolic stroke.
• a major drawback of the WATCHMAN device is the fixation of barbs or wires engaged in the walls of the LAA, thereby causing adverse events.
• pericardial effusion which is the abnormal accumulation of fluid in the pericardial cavity, which can negatively affect heart function.
• Another adverse event is the tearing of the walls of the LAA by the barb wires, thereby necessitating emergent surgery. The tearing of the LAA may lead to bleeding, which is an emergent situation that requires quick, decisive action to stop the bleeding and stabilize the patient.
• Ligation of the LAA is yet another stroke prevention technique for patients intolerant of warfarin.
• the LAA is ligated with a suture using a percutaneous epicardial approach, resulting in a complete closure of the LAA.
• a major drawback of this approach is the risks of bleeding and tears in the LAA.
• the present invention addresses the foregoing needs with apparatuses and methods for treating and preventing bleeding arising from the LAA, at the pre-hemorrhage and post- hemorrhage stages, using catheters comprising of inflatable catheter balloons.
• a method for treating and preventing bleeding arising from the LAA comprises the steps of introducing a catheter into a body cavity, advancing a guide wire tip and a catheter sheath of the catheter to and through an ostium of the LAA, and into a cavity of the LAA, inflating a first inflatable catheter balloon having a first set of electromagnetic coils, wherein upon inflation of the first catheter balloon, the first set of electromagnetic coils also expand, performing a tug test on the inflated first catheter balloon to occlude the LAA ostium, inflating a second inflatable catheter balloon, and inflating a third inflatable catheter balloon having a second set of electromagnetic coils, and wherein upon inflation of the third catheter balloon, the second set of electromagnetic coils also expand.
• the third inflatable catheter balloon can be inflated before the second inflatable catheter balloon.
• the method further comprising the step of puncturing the LAA cavity, wherein the puncturing is in a direction from within the LAA cavity and into a pericardial cavity.
• the method wherein the body cavity is a femoral vein, a jugular vein, an axillary vein, a subclavian vein, or an apex of a left ventricle.
• a method for treating and preventing bleeding arising from the LAA comprises the steps of introducing a catheter into a body cavity, advancing a guide wire tip and an inner catheter sheath of the catheter to and through an ostium of the LAA, and into a cavity of the LAA, inflating a first inflatable catheter balloon, pulling the inflated first catheter balloon, from the LAA cavity and towards the LAA ostium, to occlude the LAA ostium, advancing an outer catheter sheath of the catheter towards the guide wire tip, inflating a second inflatable catheter balloon, and pushing the inflated second catheter balloon, from the left atrium and towards the LAA ostium, to occlude the LAA ostium.
• the method further comprises the step of deploying means for locking in place the inflated first catheter balloon and the inflated second catheter balloon.
• the method further comprising the step of puncturing the LAA cavity, wherein the puncturing is in a direction from within the LAA cavity and into a pericardial cavity.
• the method wherein the body cavity is a femoral vein, a jugular vein, an axillary vein, a subclavian vein, or an apex of a left ventricle.
• a method for treating and preventing bleeding arising from the LAA comprises the steps of introducing a catheter into a cavity of the LAA, advancing a guide wire tip of the catheter to and through an ostium of the LAA, and into a left atrium, advancing a catheter sheath of the catheter towards the guide wire tip, inflating a first inflatable catheter balloon having a first set of electromagnetic coils, and wherein upon inflation of the first catheter balloon, the first set of electromagnetic coils also expand, pulling the inflated first catheter balloon from the left atrium and towards the LAA ostium, and inflating a second inflatable catheter balloon having a second set of electromagnetic coils.
• a method for treating and preventing bleeding arising from the LAA comprises the steps of introducing a catheter into a cavity of the LAA, advancing a guide wire tip of the catheter to and through an ostium of the LAA, and into a left atrium, advancing a catheter sheath of the catheter towards the guide wire tip, inflating a first inflatable endocardial catheter balloon having a first set of electromagnetic coils, and wherein upon inflation of the first endocardial catheter balloon, the first set of electromagnetic coils also expand, pulling the inflated first endocardial catheter balloon from the left atrium and towards the LAA ostium, deploying a constricting circumferential inflatable epicardial catheter balloon, having a second set of electromagnetic coils, around a circumference of the LAA ostium epicardially, inflating the epicardial catheter balloon, wherein upon inflation of the epicardial catheter balloon, the second set of electromagnetic coils also expand, and inflating a second inflatable endocardial catheter balloon af
• FIG. 1 is a perspective view of an exemplary embodiment of the present invention's apparatus for treating and preventing bleeding arising from the LAA.
• FIG. 2 is a perspective view of a second exemplary embodiment of the present invention's apparatus for treating and preventing bleeding arising from the LAA.
• FIG. 3 is a perspective view of a third exemplary embodiment of the present invention's apparatus for treating and preventing bleeding arising from the LAA.
• FIG. 4 is a perspective view of a fourth exemplary embodiment of the present invention's apparatus for treating and preventing bleeding arising from the LAA.
• FIG. 5 is a flowchart depicting an exemplary embodiment of the present invention's method for treating and preventing bleeding arising from the LAA utilizing catheter 100 as shown in FIGS. 1, and 6-8.
• FIG. 6 is a first perspective view of the exemplary embodiment of FIG. 1 when deployed into the LAA.
• FIG. 7 is a second perspective view of the exemplary embodiment of FIG. 1 when deployed into the LAA.
• FIG. 8 is a third perspective view of the exemplary embodiment of FIG. 1 when deployed into the LAA.
• FIG. 9 is a flowchart depicting an exemplary embodiment of the present invention's method for treating and preventing bleeding arising from the LAA utilizing catheter 200 as shown in FIGS. 3, and 10-12.
• FIG. 10 is a first perspective view of the exemplary embodiment of FIG. 3 when deployed into the LAA.
• FIG. 11 is a second perspective view of the exemplary embodiment of FIG. 3 when deployed into the LAA.
• FIG. 12 is a third perspective view of the exemplary embodiment of FIG. 3 when deployed into the LAA.
• FIG. 13 is a flowchart depicting an exemplary embodiment of the present invention's method for treating and preventing bleeding arising from the LAA utilizing catheters 400 and 1800 as shown in FIGS. 4, 10, 14, and 18A-18B.
• FIG. 14 is a perspective view of the exemplary embodiments of FIGS. 4 and 18A- 18B when apparatus 400 is deployed into the LAA in the endocardial layer, and when apparatus 1800 is deployed around the LAA in the epicardial layer.
• FIG. 15 is a flowchart depicting an exemplary embodiment of the present invention's method for treating and preventing bleeding arising from the LAA utilizing catheter 200 as shown in FIGS. 2, 16, and 17.
• FIG. 16 is a perspective view of the exemplary embodiment of FIG. 2 when deployed into the LAA.
• FIG. 17 is a perspective view of the locking means in the exemplary embodiment of FIG. 2.
• FIG. 18A is a perspective view of a fourth exemplary embodiment of the present invention's apparatus for treating and preventing bleeding arising from the LAA.
• FIG. 18B is a perspective view of the exemplary embodiment of FIG. 18B when deployed around the LAA ostium.
• FIG. 1 is a perspective view of an exemplary embodiment of the present invention's apparatus for treating and preventing bleeding arising from the LAA.
• FIG. 1 shows a standalone catheter 100 before it is introduced into a body cavity.
• FIG. 1 shows inflatable catheter balloons 102, 103, and 104 in their un-inflated form.
• Inflatable catheter balloons 102, 103, and 104 are affixed to catheter sheath 101.
• inflatable catheter balloons 102, 103, and 104 can be made of rubber, latex, polyisoprene, silicone, polyurethane, or any combination thereof. Rubber, latex, polyisoprene, and silicone produce more compliant inflatable catheter balloons.
• Polyurethane produces less compliant inflatable catheter balloons.
• a mixture of silicone and polyurethane produces half-way compliant inflatable catheter balloons.
• inflatable catheter balloon 102 is more compliant because when inflated, its shape assumes the contours of its surroundings in the LAA cavity, as shown in FIG. 8.
• a semi-compliant or a non-compliant inflatable catheter balloon will likely deform and expand the wall of the LAA.
• inflatable catheter balloons 102, 103, and 104 can be compliant, semi- compliant, or non-compliant, or any combination of the foregoing.
• catheter 100 can be made up of only one inflatable catheter balloon, two inflatable catheter balloons, or more than three inflatable catheter balloons.
• Inflatable catheter balloon 102 is inflated with the input of air, or a liquid material that is mixed with radiopaque contrast, via inflation port 1 1 1 through catheter sheath openings 105a, 105b, and 105c.
• Inflatable catheter balloon 103 is inflated with the input of air, or a liquid material that is mixed with radiopaque contrast, via inflation port 1 1 1 through catheter sheath openings 106a, 106b, and 106c.
• Inflatable catheter balloon 104 is inflated with the input of air, or a liquid material that is mixed with radiopaque contrast, via inflation port 1 1 1 through catheter sheath opening 107. It is contemplated that the number of catheter sheath openings can vary.
• inflatable catheter balloon 102 can be inflated via inflation port 1 1 1 through only one catheter sheath opening, or through more than three catheter sheath openings.
• Inflation port 111 provides the portal for the input of air, or a liquid material that is mixed with radiopaque contrast, by, for example, a balloon catheter inflation device.
• inflatable catheter balloon 102 When inflated, inflatable catheter balloon 102 has a larger area than that of inflatable catheter balloon 103, as shown in FIG. 8. When inflated, inflatable catheter balloon 103 has a larger area than inflatable catheter balloon 104, as shown in FIG. 8. When inflated, inflatable catheter balloon 104 has a larger diameter than that of the LAA ostium, and those of inflatable catheter balloons 102 and 103, as shown in FIG. 8. Thus, when inflated, inflatable catheter balloon 104 has a larger circumference than that of the LAA ostium, and those of inflatable catheter balloons 102 and 103, as shown in FIG. 8.
• Electromagnetic coils 113 are located within the proximal portions of inflatable catheter balloon 103. Electromagnetic coils 1 14 are located within the distal portions of inflatable catheter balloon 104. When inflatable catheter balloons 103 and 104 are inflated, electromagnetic coils 113 and 114 also expand, as shown in FIG. 8. Electromagnetic coils 113 and 114 are insulated wires coiled together to form a solenoid, and thus, can be made out of copper or any other metallic wire capable of conducting electricity.
• Guide wire tip 109 is a J-hooked, soft-tipped guide wire. Guide wire tip 109 is the first component of catheter 100 introduced into the body cavity. Guide wire tip 109 guides catheter 100 to the desired location.
• the length of guide wire 1 15 can vary depending on where guide wire tip 109 is introduced into the body cavity, and the body cavity dimensions of the particular patient.
• the length of catheter sheath 101 can vary depending on where guide wire tip 109 is introduced into the body cavity, and the body cavity dimensions of the particular patient.
• Radiopaque marker bands 108a, 108b, 108c, and 108d are thin metal tubes affixed along catheter sheath 101 to provide spatial guidance under an X-ray fluoroscope.
• Radiopaque marker band 108a marks the distal end of inflatable catheter balloon 102.
• Radiopaque marker band 108b marks the intersection of the proximal end of inflatable catheter balloon 102 and the distal end of inflatable catheter balloon 103.
• Radiopaque marker band 108c marks the intersection of the proximal end of inflatable catheter balloon 103 and the distal end of inflatable catheter balloon 104, and when catheter 100 is introduced into the body cavity, radiopaque marker band 108c marks the mid-point of the LAA ostium, as shown in FIG. 8.
• Radiopaque marker band 108d marks the distal end of inflatable catheter balloon 104.
• FIG. 2 is a perspective view of a second exemplary embodiment of the present invention's apparatus for treating and preventing bleeding arising from the LAA.
• FIG. 2 shows a stand-alone catheter 200 before it is introduced into a body cavity.
• FIG. 2 shows inflatable catheter balloons 202 and 204 in their un-infiated form.
• Inflatable catheter balloon 202 is affixed to inner catheter sheath 201.
• Inflatable catheter balloon 204 is affixed to outer catheter sheath 203.
• inflatable catheter balloons 202 and 204 can be made of rubber, latex, polyisoprene, silicone, polyurethane, or any combination thereof.
• inflatable catheter balloon 202 is more compliant because when inflated, its shape assumes the contours of its surroundings in the LAA cavity, as shown in FIG. 16.
• a semi-compliant or a non- compliant inflatable catheter balloon will likely deform and expand the wall of the LAA. It is contemplated that inflatable catheter balloons 202 and 204 can be compliant, semi-compliant, or non-compliant, or any combination of the foregoing.
• catheter 200 can be made up of only one inflatable catheter balloon, or more than two inflatable catheter balloons.
• an additional inflatable catheter balloon, distal to inflatable catheter balloon 202 and radiopaque marker band 207a on inner catheter sheath 201 can be affixed to inner catheter sheath 201.
• Inflatable catheter balloon 202 is inflated with the input of air, or a liquid material that is mixed with radiopaque contrast, via inflation port 212 through catheter sheath openings 205a, 205b, and 205c.
• inflatable catheter balloon 204 is inflated with the input of air, or a liquid material that is mixed with radiopaque contrast, via inflation port 212 through catheter sheath openings 206a and 206b.
• the number of catheter sheath openings can vary.
• inflatable catheter balloon 202 can be inflated via inflation port 212 through only one catheter sheath opening, or through more than three catheter sheath openings.
• Inflation port 212 provides the portal for the input of air by, or a liquid material that is mixed with radiopaque contrast, by, for example, a balloon catheter inflation device.
• inflatable catheter balloon 204 When inflated, inflatable catheter balloon 204 has a larger diameter than that of the LAA ostium, and that of inflatable catheter balloon 202, as shown in FIG. 16. Thus, when inflated, inflatable catheter balloon 204 has a larger circumference than that of the LAA ostium, and that of inflatable catheter balloon 202, as shown in FIG. 16.
• Guide wire tip 208 is a J-hooked, soft-tipped guide wire. Guide wire tip 208 is the first component of catheter 200 introduced into the body cavity. Guide wire tip 208 guides catheter 200 to the desired location.
• the length of guide wire 214 can vary depending on where guide wire tip 208 is introduced into the body cavity, and the body cavity dimensions of the particular patient.
• the length of inner catheter sheath 201 and outer catheter sheath 203 can vary depending on where guide wire tip 208 is introduced into the body, and the body cavity dimensions of the particular patient.
• Radiopaque marker bands 207a and 207b are thin metal tubes placed along inner catheter sheath 201 to provide spatial guidance under an X-ray fluoroscope.
• Radiopaque marker band 207a marks the distal end of inflatable catheter balloon 202.
• Radiopaque marker band 207b marks the intersection of the proximal end of inflatable catheter balloon 202 and the distal end of inflatable catheter balloon 204, and when catheter 200 is introduced into the body cavity, radiopaque marker band 207b marks the mid-point of the LAA ostium, as shown in FIG. 16.
• locking means 209 is deployed, as shown in FIGS. 16 and 17.
• Locking means 209 is shown in FIG. 17.
• Locking means 209 is a spring-loaded device housed in inner catheter sheath 202 that upon deployment, it would bulge out through the corresponding slots in outer catheter sheath 203, thereby locking in place inflatable catheter balloons 202 and 204.
• Control port 213 provides the portal for connection to catheter handling devices designed to control and navigate guide wire tip 208 and guide wire 214 to the desired location. Control port 213 also provides the portal for the insertion of additional guide wire for guide wire 214.
• FIG. 3 is a perspective view of a third exemplary embodiment of the present invention's apparatus for treating and preventing bleeding arising from the LAA.
• FIG. 3 shows a stand-alone catheter 300 before it is introduced into a body cavity.
• FIG. 3 shows inflatable catheter balloons 302 and 303 in their un- inflated form.
• Inflatable catheter balloons 302 and 303 are affixed to catheter sheath 301.
• inflatable catheter balloons 302 and 303 can be made of rubber, latex, polyisoprene, silicone, polyurethane, or any combination thereof.
• FIG. 3 shows a stand-alone catheter 300 before it is introduced into a body cavity.
• inflatable catheter balloons 302 and 303 in their un- inflated form.
• Inflatable catheter balloons 302 and 303 are affixed to catheter sheath 301.
• inflatable catheter balloons 302 and 303 can be made of rubber, latex, polyisoprene, silicone, polyurethane, or any combination thereof
• inflatable catheter balloon 303 is more compliant because when inflated, its shape assumes the contours of its surroundings in the LAA cavity, as shown in FIG. 12. On the other hand, a semi-compliant or a non-compliant catheter balloon will likely deform and expand the wall of the LAA. It is contemplated that inflatable catheter balloons 302 and 303 can be compliant, semi-compliant, or non-compliant, or any combination of the foregoing. Additionally, it is contemplated that catheter 300 can be made up of only one inflatable catheter balloon, or more than two inflatable catheter balloons. For example, an additional inflatable catheter balloon, distal to inflatable catheter balloon 303 on catheter sheath 301, can be affixed to catheter sheath 301.
• Inflatable catheter balloon 302 is inflated with the input of air, or a liquid that is mixed with radiopaque contrast, via inflation port 309 through catheter sheath openings 304a, 304b, and 304c.
• inflatable catheter balloon 303 is inflated with the input of air, or a liquid that is mixed with radiopaque contrast, from inflation port 309 via catheter sheath openings 305a, 305b, and 305c.
• the number of catheter sheath openings can vary.
• inflatable catheter balloon 302 can be inflated via inflation port 309 through only one catheter sheath opening, or through more than three catheter sheath openings.
• Inflation port 309 provides the portal for the input of air, or a liquid that is mixed with radiopaque contrast, by, for example, a balloon catheter inflation device.
• Electromagnetic coils 31 1 are located within the proximal portions of inflatable catheter balloon 302. Electromagnetic coils 312 are located within the distal portions of inflatable catheter balloon 303. When inflatable catheter balloons 302 and 303 are inflated, electromagnetic coils 31 1 and 312 also expand, as shown in FIG. 12. Electromagnetic coils 31 1 and 312 are insulated wires coiled together to form a solenoid, and thus, can be made out of copper or any other metallic wire capable of conducting electricity.
• Guide wire tip 307 is a J-hooked, soft-tipped guide wire.
• Guide wire tip 307 is the first component of catheter 300 introduced into the body cavity.
• Guide wire tip 307 guides catheter 300 to the desired location.
• the length of guide wire 313 can vary depending on where guide wire tip 307 is introduced into the body cavity, and the body cavity dimensions of the particular patient.
• the length of catheter sheath 301 can vary depending on where guide wire tip 307 is introduced into the body cavity, and the body cavity dimensions of the particular patient.
• Radiopaque marker band 306 is a thin metal tube placed along catheter sheath 301 to provide spatial guidance under an X-ray fluoroscope. Radiopaque marker band 306 marks the intersection of the proximal end of inflatable catheter balloon 302 and the distal end of inflatable catheter balloon 303.
• Control port 310 provides the portal for connection to catheter handling devices designed to control and navigate guide wire tip 307 and guide wire 313 to the desired location. Control port 310 also provides the portal for the insertion of additional guide wire for guide wire 313.
• FIG. 4 is a perspective view of a fourth exemplary embodiment of the present invention's apparatus for treating and preventing bleeding arising from the LAA.
• FIG. 4 shows a stand-alone catheter 400 before it is introduced into a body cavity.
• FIG. 4 shows inflatable endocardial catheter balloons 402 and 403 in their un-inflated form.
• Inflatable endocardial catheter balloons 402 and 403 are affixed to catheter sheath 401.
• inflatable endocardial catheter balloons 402 and 403 can be made of rubber, latex, polyisoprene, silicone, polyurethane, or any combination thereof. Rubber, latex, polyisoprene, and silicone produce more compliant inflatable catheter balloons.
• Polyurethane produces less compliant inflatable catheter balloons.
• a mixture of silicone and polyurethane produces half-way compliant inflatable catheter balloons.
• inflatable endocardial catheter balloon 403 is more compliant because when inflated, its shape assumes the contours of its surroundings in the LAA cavity, as shown in FIG. 14.
• a semi-compliant or a non-compliant catheter balloon will likely deform and expand the wall of the LAA.
• inflatable endocardial catheter balloons 402 and 403 can be compliant, semi-compliant, or non-compliant, or any combination of the foregoing.
• catheter 400 can be made up of more than two inflatable endocardial catheter balloons.
• an additional inflatable endocardial catheter balloon, distal to inflatable endocardial catheter balloon 403 on catheter sheath 401 can be affixed to catheter sheath 401.
• Inflatable endocardial catheter balloon 402 is inflated with the input of air, or a liquid that is mixed with radiopaque contrast, via inflation port 409 through catheter sheath openings 404a, 404b, and 404c.
• inflatable endocardial catheter balloon 403 is inflated with the input of air, or a liquid that is mixed with radiopaque contrast, via inflation port 409 through catheter sheath openings 405a, 405b, and 405c.
• the number of catheter sheath openings can vary.
• inflatable endocardial catheter balloon 402 can be inflated via inflation port 409 through only one catheter sheath opening, or through more than three catheter sheath openings.
• Inflation port 409 provides the portal for the input of air, or a liquid that is mixed with radiopaque contrast, by, for example, a balloon catheter inflation device.
• the distal portions of inflatable endocardial catheter balloon 402 When inflated, the distal portions of inflatable endocardial catheter balloon 402 has a larger diameter than that of the LAA ostium, and that of inflatable endocardial catheter balloon 403, as shown in FIG. 14. Thus, when inflated, the distal portions of inflatable endocardial catheter balloon 402 has a larger circumference than that of the LAA ostium, and that of inflatable endocardial catheter balloon 403, as shown in FIG. 14.
• Electromagnetic coils 41 1 are located within the proximal portions of inflatable endocardial catheter balloon 402. When inflatable endocardial catheter balloon 402 is inflated, electromagnetic coils 411 also expand, as shown in FIG. 11. Electromagnetic coils 41 1 are insulated wires coiled together to form a solenoid, and thus, can be made out of copper or any other metallic wire capable of conducting electricity.
• Guide wire tip 406 is a J-hooked, soft-tipped guide wire. Guide wire tip 406 is the first component of catheter 400 introduced into the body cavity. Guide wire tip 406 guides catheter 400 to the desired location.
• the length of guide wire 412 can vary depending on where guide wire tip 406 is introduced into the body cavity, and the body cavity dimensions of the particular patient.
• the length of catheter sheath 401 can vary depending on where guide wire tip 406 is introduced into the body, and the body cavity dimensions of the particular patient.
• Radiopaque marker band 407 is a thin metal tube placed along catheter sheath 401 to provide spatial guidance under an X-ray fluoroscope. Radiopaque marker band 407 marks the intersection of the proximal end of inflatable endocardial catheter balloon 402 and the distal end of inflatable endocardial catheter balloon 403, as shown in FIG. 14.
• Control port 410 provides the portal for connection to catheter handling devices designed to control and navigate guide wire tip 406 and guide wire 412 to the desired location. Control port 410 also provides the portal for the insertion of additional guide wire for guide wire 412.
• FIG. 5 is a flowchart depicting an exemplary embodiment of the present invention's method for treating and preventing bleeding arising from the LAA utilizing catheter 100 as shown in FIGS. 1, and 6-8.
• catheter 100 is introduced into a body cavity.
• catheter 100 can be introduced into a body cavity via a puncture and an insertion of guide wire tip 109 into the body.
• Catheter 100 can be introduced into different body cavities, such as via a femoral vein, a jugular vein, an axillary vein, or a subclavian vein.
• catheter 100 can be introduced directly into the chambers of the heart via introduction at the apex of the left ventricle.
• guide wire tip 109 is advanced to and through the LAA ostium, and into the LAA cavity. For example, if guide wire tip 109 was introduced into the body cavity via the femoral vein, then guide wire tip 109 can be advanced transseptally to and through the LAA ostium, and into the LAA cavity using an endovascular approach.
• catheter sheath 101 is advanced towards the direction of guide wire tip 109.
• catheter sheath 101 can be advanced transseptally to and through the LAA ostium, and into the LAA cavity using an endovascular approach.
• catheter sheath 101 is advanced until it is close to, but prior to, guide wire tip 109.
• catheter sheath 101 is advanced until inflatable catheter balloon 103 advances through the LAA ostium and slightly into the LAA cavity.
• Radiopaque marker band 108c can provide guidance as to when inflatable catheter balloon 103 advances through the LAA ostium and slightly into the LAA cavity.
• inflatable catheter balloon 103 having electromagnetic coils 1 13 is inflated distal to the LAA ostium, as shown in FIG. 6.
• Inflatable catheter balloon 103 is inflated by the input of air, or a liquid that is mixed with radiopaque contrast, via inflation port 1 1 1 through catheter sheath openings 106a, 106b, and 106c.
• the shape of inflatable catheter balloon 103 assumes the contours of its surroundings in the LAA cavity.
• inflatable catheter balloon 103 occludes the LAA ostium as well as the potential sites for tear or perforation in the LAA cavity, thereby treating and preventing bleeding arising from the LAA.
• electromagnetic coils 113 located within the proximal portions of inflatable catheter balloon 103 also expand.
• electromagnetic coils 1 13 are located immediately distal to the LAA ostium, as shown in FIG. 6.
• a tug test is performed to ensure that inflatable catheter balloon 103 firmly occludes the LAA ostium, as shown in FIG. 6.
• a "tug test” is a term of art known to one skilled in the art.
• the tug test is the pulling back of inflatable catheter balloon 103, from the LAA cavity and towards the LAA ostium, in a manner that firmly occludes the LAA ostium.
• inflatable catheter balloon 102 is inflated distal to inflatable catheter balloon 103, as shown in FIG. 7.
• Inflatable catheter balloon 102 is inflated by the input of air, or a liquid that is mixed with radiopaque contrast, via inflation port 1 11 through catheter sheath openings 105a, 105b, and 105c.
• the shape of inflatable catheter balloon 102 assumes the contours of its surroundings in the LAA cavity, as shown in FIG. 7.
• inflatable catheter balloon 102 occludes the potential sites for tear or perforation in the LAA cavity, thereby treating and preventing bleeding arising from the LAA.
• inflatable catheter balloon 104 having electromagnetic coils 1 14 is inflated proximal to the LAA ostium, as shown in FIG. 8.
• Inflatable catheter balloon 104 is inflated by the input of air, or a liquid that is mixed with radiopaque contrast, via inflation port 11 1 through catheter sheath opening 107.
• electromagnetic coils 1 14 located within the distal portions of inflatable catheter balloon 104 also expand.
• electromagnetic coils 1 14 are located immediately proximal to the LAA ostium, as shown in FIG. 8.
• inflatable catheter balloons 103 and 104 are attracted towards and adhere to each other, thereby causing these balloons to firmly occlude the LAA ostium, as shown in FIG. 8.
• inflatable catheter balloon 104 When inflated, inflatable catheter balloon 104 has a diameter larger than that of the LAA ostium, and larger than that of inflatable catheter balloon 103.
• inflatable catheter balloon 104 When inflated, inflatable catheter balloon 104 has a circumference larger than that of the LAA ostium, and larger than that of inflatable catheter balloon 103. This ensures that the LAA ostium is firmly occluded, as shown in FIG. 8. By firming occluding the LAA ostium, any bleeding arising from the LAA is treated and prevented.
• the LAA cavity is punctured in a direction from within the LAA cavity and into the pericardial cavity so that there is no risk of bleeding into the pericardial space.
• a tip of the LAA cavity can be punctured using catheter sheath 101.
• FIGS. 6-8 are perspective views of the exemplary embodiment of FIG. 1 when deployed into the LAA.
• FIG. 9 is a flowchart depicting an exemplary embodiment of the present invention's method for treating and preventing bleeding arising from the LAA utilizing catheter 300 as shown in FIGS. 3, and 10-12.
• catheter 300 is introduced into a body cavity via the LAA cavity.
• guide wire tip 307 is introduced into the body cavity via a puncture and an insertion at the tip of the LAA cavity, as shown in FIG. 10.
• a tissue grasper with soft jaws of varying width is used to hold the LAA stationary while the tip of the LAA cavity is punctured with, for example, a hollow needle. This tissue grasper also serves to maintain hemostasis.
• the guide wire tip 307 is introduced into the body cavity via a punctured location at the tip of the LAA, and into the LAA cavity.
• guide wire tip 307 is advanced to and through the LAA ostium, and into the left atrium, as shown in FIG. 10.
• catheter sheath 301 is advanced towards the direction of guide wire tip 307, as shown in FIG. 11. Accordingly, as shown in FIG. 11 , catheter sheath 301 is advanced to and through the LAA ostium, and into the left atrium. As shown in FIG. 1 1 , catheter sheath 301 is advanced until it is close to, but prior to, guide wire tip 307.
• inflatable catheter balloon 302 having electromagnetic coils 31 1 is inflated at the tip of catheter sheath 301, as shown in FIG. 1 1.
• Inflatable catheter balloon 302 is inflated by the input of air, or a liquid that is mixed with radiopaque contrast, via inflation port 309 through catheter sheath openings 304a, 304b, and 304c.
• electromagnetic coils 311 located within the proximal portions also expand, as shown in FIG. 11.
• the inflated catheter balloon 302 is pulled back, from the left atrium towards the LAA ostium, to occlude the LAA ostium, as shown in FIG. 1 1.
• inflatable catheter balloon 303 having electromagnetic coils 312 is inflated near the LAA ostium, as shown in FIG. 12.
• Inflatable catheter balloon 303 is inflated by the input of air, or a liquid that is mixed with radiopaque contrast, via inflation port 309 through catheter sheath openings 305a, 305b, and 305c.
• the shape of inflatable catheter balloon 303 assumes the contours of its surroundings in the LAA cavity, as shown in FIG. 12.
• inflatable catheter balloon 303 occludes the potential sites for tear or perforation in the LAA cavity, thereby treating and preventing bleeding arising from the LAA.
• electromagnetic coils 312 located within the distal portions of inflatable catheter balloon 303 also expand, as shown in FIG. 12.
• electromagnetic forces via the interaction of electromagnetic coils 31 1 and 312 inflatable catheter balloons 302 and 303 are attracted towards and adhere to each other, thereby causing these balloons to firmly occlude the LAA ostium, as shown in FIG. 12.
• firming occluding the LAA ostium any bleeding arising from the LAA is treated and prevented.
• FIGS. 10-12 are perspective views of the exemplary embodiment of FIG. 3 when deployed into the LAA.
• FIG. 13 is a flowchart depicting an exemplary embodiment of the present invention's method for treating and preventing bleeding arising from the LAA utilizing catheters 400 and 1800 as shown in FIGS. 4, 10, 14, and 18A-18B.
• catheter 400 is introduced into a body cavity via the LAA cavity.
• guide wire tip 406 can be introduced into the body cavity via a puncture and an insertion at the tip of the LAA cavity, as shown in FIG. 10.
• a tissue grasper with soft jaws of varying width is used to hold the LAA stationary while the tip of the LAA cavity is punctured with, for example, a hollow needle. This tissue grasper also serves to maintain hemostasis.
• guide wire tip 406 is introduced into the body cavity via a punctured location at the tip of the LAA, and into the LAA cavity.
• guide wire tip 406 is advanced to and through the LAA ostium, and into the left atrium, as previously shown in FIG. 10.
• catheter sheath 401 is advanced towards the direction of guide wire tip 406. Accordingly, catheter sheath 401 is advanced to and through the LAA ostium, and into the left atrium. Catheter sheath 401 is advanced until it is close to, but prior to, guide wire tip 406.
• inflatable endocardial catheter balloon 402 having electromagnetic coils 41 1 is inflated at the tip of catheter sheath 401. Inflatable endocardial catheter balloon 402 is inflated by the input of air, or a liquid that is mixed with radiopaque contrast, via inflation port 409 through catheter sheath openings 404a, 404b, and 404c. When inflatable endocardial catheter balloon 411 is inflated, electromagnetic coils 41 1 located within the distal portions of inflatable endocardial catheter balloon 402 also expand, as shown in FIG. 14.
• inflated endocardial catheter balloon 402 is pulled back from the left atrium towards the LAA ostium, and slightly into the LAA cavity, as shown in FIG. 14.
• electromagnetic coils 41 1 located within the proximal portions of inflated endocardial catheter balloon 402, align near the mid-point of the LAA ostium.
• the end facing the left atrium has a larger diameter than that of the end facing the LAA cavity.
• the end facing the left atrium has a larger circumference than that of the end facing the LAA cavity.
• constricting circumferential epicardial balloon 1801 having electromagnetic coils 1802 is deployed around the circumference of the LAA ostium in the epicardium layer of the heart, as shown in FIG. 18B. This deployment can be performed manually by a physician.
• constricting circumferential inflatable epicardial catheter balloon 1 801 is inflated.
• Inflatable epicardial catheter balloon 1801 is inflated by the input of air, or a liquid that is mixed with radiopaque contrast, via inflation port 1805 through catheter sheath openings 1803a-1803h.
• electromagnetic coils 1802 located within constricting circumferential epicardial balloon 1802 also expand, as shown in FIGS. 14 and 18B.
• inflatable endocardial catheter balloon 402 and inflatable epicardial catheter balloon 1802 are attracted towards each other, thereby forming a tight hemostatic seal, as shown in FIG. 14. This tight hemostatic seal helps treat and prevent bleeding arising from the LAA.
• inflatable endocardial catheter balloon 403 is inflated in the LAA cavity, as shown in FIG. 14.
• Inflatable endocardial catheter balloon 403 is inflated by the input of air, or a liquid that is mixed with radiopaque contrast, via inflation port 409 through catheter sheath openings 405a, 405b, and 405c.
• the shape of inflatable endocardial catheter balloon 403 assumes the contours of its surroundings in the LAA cavity, as shown in FIG. 14. By assuming the contours of its surroundings, inflatable endocardial catheter balloon 403 occludes the potential sites for tear or perforation in the LAA cavity, thereby treating and preventing bleeding arising from the LAA.
• FIG. 14 is a perspective view of the exemplary embodiments of FIGS. 4 and 18A- 18B when apparatus 400 is deployed into the LAA in the endocardial layer, and when apparatus 1800 is deployed around the LAA in the epicardial layer.
• FIG. 15 is a flowchart depicting an exemplary embodiment of the present invention's method for treating and preventing bleeding arising from the LAA utilizing catheter 200 as shown in FIGS. 2, 16, and 17.
• catheter 100 is introduced into a body cavity.
• catheter 200 can be introduced into a body cavity via a puncture and an insertion of guide wire tip 208 into the body.
• Catheter 200 can be introduced into different body cavities, such as via a femoral vein, a jugular vein, an axillary vein, or a subclavian vein.
• catheter 200 can be introduced directly into the chambers of the heart via introduction at the apex of the left ventricle.
• guide wire tip 208 is advanced to and through the LAA ostium, and into the LAA cavity. For example, if guide wire tip 208 was introduced into the body cavity via the femoral vein, then guide wire tip 208 can be advanced transseptally to and through the LAA ostium, and into the LAA cavity using an endovascular approach.
• inner catheter sheath 201 is advanced towards the direction of guide wire tip 208. As shown in FIG. 16, inner catheter sheath 201 is advanced until it is close to, but prior to, guide wire tip 208. For example, if guide wire tip 208 was introduced into the body cavity via the femoral vein, then inner catheter sheath 201 can be advanced until it is close to, but prior to, guide wire tip 208.
• inflatable catheter balloon 202 is inflated distal to the LAA ostium, as shown in FIG. 16.
• Inflatable catheter balloon 202 is inflated by the input of air, or a liquid that is mixed with radiopaque contrast, via inflation port 212 through catheter sheath openings 205a, 205b, 205c.
• inflated catheter balloon 202 is pulled, from the LAA cavity and towards the LAA ostium, to occlude the LAA ostium. Also, the shape of inflated catheter balloon 202 assumes the contours of its surroundings in the LAA cavity. By assuming the contours of its surroundings, inflatable catheter balloon 202 occludes the potential sites for tear or perforation in the LAA cavity, thereby treating and preventing bleeding arising from the LAA.
• outer catheter sheath 203 is advanced towards the direction of guide wire tip 208. However, as shown in FIG. 16, outer catheter sheath 203 is advanced until it reaches the left atrium and prior to the LA ostium. For example, if guide wire tip 208 was introduced into the body cavity via the femoral vein, then out catheter sheath 203 can be advanced until it reaches the left atrium and prior to the LA ostium.
• inflatable catheter balloon 204 is inflated while it is in the left atrium. Inflatable catheter balloon 204 is inflated by the input of air, or a liquid that is mixed with radiopaque contrast, via inflation port 212 through catheter sheath openings 206a and 206b.
• inflated catheter balloon 204 is from the left atrium and towards the LAA ostium.
• inflatable catheter balloon 204 has a diameter larger than that of the LAA ostium, and larger than that of inflatable catheter balloon 202, as shown in FIG. 16.
• catheter balloon 204 has a circumference larger than that of the LAA ostium, and larger than that of inflatable catheter balloon 202. This ensures that the LAA ostium is firmly occluded, as shown in FIG. 16. By firming occluding the LAA ostium, any bleeding arising from the LAA is treated and prevented.
• locking means 209 is deployed to render inflated catheter balloons 202 and 204 stationary.
• Locking means 209 is a spring-loaded device housed in inner catheter sheath 202 that upon deployment, it would bulge out through the corresponding slots in outer catheter sheath 203, thereby locking in place inflated catheter balloons 202 and 204.
• the LAA cavity is punctured in a direction from within the LAA cavity and into the pericardial cavity so that there is no risk of bleeding into the pericardial space.
• a tip of the LAA cavity can be punctured using inner catheter sheath 202.
• FIG. 16 is a perspective view of the exemplary embodiment of FIG. 2 when deployed into the LAA.
• FIG. 17 is a perspective view of the locking means in the exemplary embodiment of FIG. 2.
• FIG. 18A is a perspective view of a fourth exemplary embodiment of the present invention's apparatus for treating and preventing bleeding arising from the LAA.
• FIG. 18B is a perspective view of the exemplary embodiment of FIG. 18B when deployed around the LAA ostium.
• FIG. 18A shows a stand-alone catheter 1800 before it is introduced into a body cavity.
• FIG. 18A shows constricting circumferential epicardial balloon 1801 in its un-inflated form. Constricting circumferential epicardial balloon 1801 is affixed to catheter sheath 1804.
• constricting circumferential epicardial balloon 1801 can be made of rubber, latex, polyisoprene, silicone, polyurethane, or any combination thereof. It is contemplated that constricting circumferential epicardial balloon 1801 can be compliant, semi-compliant, or non-compliant. Additionally, it is contemplated that catheter 1800 can be made up of more than one constricting circumferential epicardial balloon.
• Constricting circumferential epicardial balloon 1801 is inflated by the input of air, or a liquid that is mixed with radiopaque contrast, via inflation port 1805 through catheter sheath openings 1803a-1803h. It is contemplated that the number of catheter sheath openings can vary. For example, constricting circumferential epicardial balloon 1801 can be inflated via inflation port 1805 through only one catheter sheath opening, or through more than eight catheter sheath openings. Inflation port 1805 provides the portal for the input of air, or a liquid that is mixed with radiopaque contrast, by, for example, a balloon catheter inflation device.
• Electromagnetic coils 1802 are located within constricting circumferential epicardial balloon 1801. When constricting circumferential epicardial balloon 1801 is inflated, electromagnetic coils 1802 also expand, as shown in FIGS. 14 and 18B. Electromagnetic coils 1802 are insulated wires coiled together to form a solenoid, and thus, can be made out of copper or any other metallic wire capable of conducting electricity.
• the length of catheter sheath 1804 can vary depending on the circumference of the particular patient's LAA ostium.
• the length of constricting circumferential epicardial balloon 1801 can also vary depending on the circumference of the particular patient's LA A ostium.
• a catheter for treating and preventing bleeding arising from a LAA comprises a guide wire with a guide wire tip, a catheter sheath, a first inflatable catheter balloon affixed to the catheter sheath, wherein the first catheter balloon is proximal to the guide wire tip, a second inflatable catheter balloon affixed to the catheter sheath, wherein the second catheter balloon is proximal to the first catheter balloon, a first set of electromagnetic coils located within the second catheter balloon, a third inflatable catheter balloon affixed to the catheter sheath, wherein the third catheter balloon is proximal to the second catheter balloon, a second set of electromagnetic coils located within the third catheter balloon, a plurality of catheter sheath openings on the catheter sheath, wherein each catheter sheath opening is enclosed by one of the catheter balloons, and wherein each of the catheter balloons encloses at least one catheter she
• the catheter further comprises at least one radiopaque marker band affixed to the catheter sheath.
• the catheter wherein the first catheter balloon is more compliant than the second catheter balloon.
• the catheter wherein the second catheter balloon is more compliant the third catheter balloon.
• the catheter wherein the third catheter balloon, when inflated, has a larger circumference than that of an ostium of the LAA.
• the catheter wherein the third catheter balloon, when inflated, has a larger circumference than that of the second catheter balloon.
• the catheter wherein the second catheter balloon, when inflated has a larger circumference than that of the first catheter balloon.
• the catheter wherein the first set of electromagnetic coils is located within a proximal end of the second catheter balloon.
• the catheter wherein the second set of electromagnetic coils is located within a distal end of the third catheter balloon.
• the catheter wherein the guide wire tip is J-hooked.
• the catheter sheath can be used for puncturing the LAA cavity.
• a catheter for treating and preventing bleeding arising from a LAA comprises a guide wire with a guide wire tip, an inner catheter sheath, an outer catheter sheath, a first inflatable catheter balloon affixed to the inner catheter sheath, wherein the first catheter balloon is proximal to the guide wire tip, at least one catheter sheath opening on the inner catheter sheath, wherein each catheter sheath opening is enclosed by the first catheter balloon, a second inflatable catheter balloon affixed to the outer catheter sheath, wherein the second catheter balloon is proximal to the first catheter balloon, at least one catheter sheath opening on the distal end of the outer catheter sheath, wherein each catheter sheath opening is enclosed by the second catheter balloon, an inflation port, and a control port.
• the catheter further comprises means for locking in place the inflated first and second catheter balloons.
• the catheter further comprises at least one radiopaque marker band affixed to the inner catheter sheath.
• the catheter further comprises at least one radiopaque marker band affixed to the outer catheter sheath.
• the catheter wherein the first catheter balloon is more compliant than the second catheter balloon.
• the catheter wherein the second catheter balloon, when inflated, has a larger circumference than that of an ostium of the LAA.
• the catheter wherein the second catheter balloon, when inflated, has a larger circumference than that of the first catheter balloon.
• the catheter wherein the guide wire tip is J-hooked.
• the inner catheter sheath has an additional lumen that can be used for puncturing the LAA cavity.
• a catheter for treating and preventing bleeding arising from a LAA comprises a guide wire with a guide wire tip, a catheter sheath, a first inflatable catheter balloon affixed to the catheter sheath, wherein the first catheter balloon is proximal to the guide wire tip, a first set of electromagnetic coils located within the first catheter balloon, a second inflatable catheter balloon affixed to the catheter sheath, wherein the second catheter balloon is proximal to the first catheter balloon, a plurality of catheter sheath openings on the catheter sheath, wherein each catheter sheath opening is enclosed by one of the catheter balloons, and wherein each of the catheter balloons encloses at least one catheter sheath opening, an inflation port, and a control port.
• the catheter further comprises at least one radiopaque marker band affixed to the catheter sheath.
• the catheter wherein the second catheter balloon is more compliant than the first catheter balloon.
• the catheter wherein the first catheter balloon, when inflated, has a larger circumference than that of an ostium of the LAA.
• the catheter wherein the first catheter balloon, when inflated, has a larger circumference than that of the second catheter balloon.
• the catheter wherein the first set of electromagnetic coils is located within a proximal end of the first catheter balloon.
• the catheter wherein the guide wire tip is J- hooked.
• the catheter wherein the distal portions of the first catheter balloon have a larger diameter than that of the proximal portions of the first catheter balloon.
• the catheter wherein the second catheter balloon further comprises a second set of electromagnetic coils.
• the catheter wherein the second set of electromagnetic coils is located within a distal end of the second catheter balloon.
• the catheter sheath can be used for puncturing the LAA cavity.
• a catheter for treating and preventing bleeding arising from a LAA comprises a guide wire with a guide wire tip, a catheter sheath, a first inflatable endocardial catheter balloon affixed to the catheter sheath, wherein the first endocardial catheter balloon is proximal to the guide wire tip, a first set of electromagnetic coils located within the first catheter balloon, a second inflatable endocardial catheter balloon affixed to the catheter sheath, wherein the second endocardial catheter balloon is proximal to the first endocardial catheter balloon, a plurality of catheter sheath openings on the catheter sheath, wherein each catheter sheath opening is enclosed by one of the endocardial catheter balloons, and wherein each of the endocardial catheter balloons encloses at least one catheter sheath opening, an inflation port, and a control port.
• the catheter further comprises at least one radiopaque marker band affixed to the catheter sheath.
• the catheter wherein the second endocardial catheter balloon is more compliant than the first endocardial catheter balloon.
• the catheter wherein the first endocardial catheter balloon, when inflated, has a larger circumference than that of an ostium of the LAA.
• the catheter wherein the first endocardial catheter balloon, when inflated, has a larger circumference than that of the second endocardial catheter balloon.
• the catheter wherein the first set of electromagnetic coils is located within a proximal end of the first endocardial catheter balloon.
• the catheter wherein the guide wire tip is J-hooked.
• a catheter for treating and preventing bleeding arising from a LAA comprises a catheter sheath, an inflatable constricting circumferential epicardial catheter balloon affixed to the catheter sheath, a set of electromagnetic coils located within the epicardial catheter balloon, a plurality of catheter sheath openings on the catheter sheath, wherein each catheter sheath opening is enclosed by the epicardial catheter balloon, and an inflation port.
• the catheter further comprises a control port.
• the catheter further comprises at least one radiopaque marker bands affixed to the catheter sheath.
• the catheter further comprises a guide wire with a guide wire tip.
• the catheter wherein the set of electromagnetic coils is located across the length of the epicardial catheter balloon.
• the catheter wherein the guide wire tip is J-hooked.
• the present invention can be used as an alternative approach to replace percutaneous aortic valves. Additionally, it is contemplated that the present invention can be used to perform a percutaneous repair of a mitral valve such as by an application of a clip to the mitral valve.

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