Inflatable occlusion devices, methods, and systems
First Claim
Patent Images
1. A method for treating a venous dysfunction in a leg of a patient, comprising:
- providing an access opening to provide access to a venous vessel of a leg of the patient;
providing a balloon having a length of at least about 10 cm, the balloon having a proximal end and a distal end and including a balloon wall formed with a remodelable sheet material harvested from a collagenous tissue, the remodelable sheet material effective to induce cellular invasion and ingrowth into the balloon wall following implantation so that the balloon wall becomes remodeled with patient tissue;
positioning the balloon such that the distal end is located at a point within the venous vessel of the leg and the proximal end is located at a point exterior to the access opening; and
passing an amount of fill material into the balloon with said proximal end being located at said point exterior to the access opening.
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Accused Products
Abstract
Described are devices, methods and systems useful for achieving occlusion of vascular vessels. Percutaneous procedures can be used to occlude and obliterate the greater saphenous vein, for example in the treatment of varicose vein condition caused by venous reflux. Certain embodiments encompass the deployment and filling of an inflatable occlusion device via a percutaneous procedure, so as to occlude or obliterate a portion of a vascular vessel.
68 Citations
34 Claims
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1. A method for treating a venous dysfunction in a leg of a patient, comprising:
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providing an access opening to provide access to a venous vessel of a leg of the patient; providing a balloon having a length of at least about 10 cm, the balloon having a proximal end and a distal end and including a balloon wall formed with a remodelable sheet material harvested from a collagenous tissue, the remodelable sheet material effective to induce cellular invasion and ingrowth into the balloon wall following implantation so that the balloon wall becomes remodeled with patient tissue; positioning the balloon such that the distal end is located at a point within the venous vessel of the leg and the proximal end is located at a point exterior to the access opening; and passing an amount of fill material into the balloon with said proximal end being located at said point exterior to the access opening.
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2. A method for occluding a portion of the vasculature for treating venous dysfunction in a leg of a patient, comprising:
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providing a percutaneous access opening to the vasculature; providing an inflatable occlusion device having a proximal end and a distal end, wherein said inflatable occlusion device is at least about 10 cm in length, and wherein said inflatable occlusion device includes a wall formed with a remodelable sheet material harvested from a collagenous tissue, the remodelable sheet material effective to induce cellular invasion and ingrowth into the wall following implantation so that the wall becomes remodeled with patient tissue; positioning the inflatable occlusion device such that the distal end is located at a point within a venous vessel of the leg and the proximal end is located at a point exterior to the access opening; and passing an amount of fill material into the inflatable occlusion device with said proximal end being located at said point exterior to the access opening. - View Dependent Claims (3, 4, 5)
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6. A method for occluding a venous vessel in a leg of a patient to treat venous dysfunction in the patient, comprising:
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providing an access opening in a vascular vessel of the patient to provide access to the venous vessel; positioning an inflatable occlusion device having a length of at least about 10 cm, a proximal end and a distal end, such that the distal end is located at a point within the venous vessel and the proximal end is located at a point exterior to the access opening, and wherein the inflatable occlusion device includes a wall formed with a remodelable sheet material harvested from a collagenous tissue, the remodelable sheet material effective to induce cellular invasion and ingrowth into the wall following implantation so that the wall becomes remodeled with atient tissue; and passing an amount of fill material into the inflatable occlusion device with said proximal end being located at said point exterior to the access opening. - View Dependent Claims (7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17)
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18. A method for treating venous dysfunction in a leg of a patient, comprising:
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providing an access opening to provide access to a vein in a leg of a patient; providing a balloon having a length of at least about 10 cm, a distal end and a proximal end, wherein the balloon includes a balloon wall formed with a remodelable sheet material harvested from a collagenous tissue, the remodelable sheet material effective to induce cellular invasion and ingrowth into the balloon wall following implantation so that the balloon wall becomes remodeled with patient tissue; positioning the balloon such that the distal end is located at a point within the vein and the proximal end is located at a point exterior to the access opening; and loading a first material into the balloon with said proximal end being located at said point exterior to the access opening during a first surgical access; and loading the balloon with a second material during a second, separate surgical access that occurs after said first surgical access. - View Dependent Claims (19)
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20. A method for treating venous dysfunction in a leg of a human, comprising;
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providing a percutaneous opening to provide access to a saphenous vein of the leg; providing an inflatable occlusion device having a proximal end and a distal end, wherein the inflatable occlusion device is at least about 10 cm in length, and wherein said inflatable occlusion device includes a wall formed with a remodelable sheet material harvested from a collagenous tissue, the remodelable sheet material effective to induce cellular invasion and ingrowth into the wall following implantation so that the wall becomes remodeled with patient tissue; positioning the inflatable occlusion device such that the distal end is located at a point within the saphenous vein and the proximal end is located at a point exterior to the percutaneous opening; and passing an amount of fill material into the inflatable occlusion device with said proximal end being located at said point exterior to the access opening, so as to occlude the saphenous vein. - View Dependent Claims (21, 22, 23, 24, 25, 26, 27, 28, 29)
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30. A method for treating venous dysfunction in a leg of a human patient by occluding a saphenous vein of the leg with ingrown tissue of the patient, the method comprising:
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providing a percutaneous access to a lumen of the saphenous vein; percutaneously inserting an inflatable occlusion balloon into the lumen of the saphenous vein through said percutaneous access, the inflatable occlusion balloon including a balloon wall formed from a remodelable extracellular matrix layer isolated from a biological tissue source, the remodelable extracellular matrix layer being effective to induce cellular invasion and ingrowth into the balloon wall following implantation so that the balloon wall becomes remodeled with patient tissue; and filling the inflatable occlusion balloon with a flowable material comprising a remodelable extracellular matrix fill material that is effective to induce cellular invasion and ingrowth following implantation so that the remodelable extracellular matrix fill material becomes remodeled with patient tissue, said filling being conducted so that the inflatable occlusion balloon, when it is filled with the remodelable extracellular matrix fill material, positions remodelable extracellular matrix material fully across the lumen of the saphenous vein so as to fully occlude the lumen of saphenous vein with remodelable extracellular matrix material; wherein after said inserting and said filling, the remodelable extracellular matrix layer and the remodelable extracellular matrix fill material become remodeled with new patient tissue that extends fully across the lumen of the saphenous vein so as to occlude the lumen of the saphenous vein with said new patient tissue. - View Dependent Claims (31, 32, 33, 34)
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Specification