Kyphoplasty System
AssigneeLentek S.r.l.
InventorSergio Lenchig
Life of this patent
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Abstract
The devices and methods described below provide for kyphoplasty procedure that is quicker and safer than current kyphoplasty methods. The method entails insertion of an asymmetric balloon catheter, with a balloon expansion limited to a minor arc relative to the catheter tube (rather than entirely encircling the catheter tube), into a crushed vertebral body with the balloon primary plane of expansion (the width of the balloon) aligned with a first plane crossing the vertebral body, thereafter inflating the balloon to deform cancellous bone within the vertebral body and create a void, followed by deflating the balloon, reorienting the balloon with the balloon primary plane of expansion (the width of the balloon) aligned with a second plane crossing the vertebral body to create a second void or enlarge the first void.
Claims9
A method of kyphoplasty on a vertebral body of a patient, said method comprising:
- inserting a balloon into the vertebral body through a pedicle, to position the balloon in a lateral portion of cancellous bone within the vertebral body;
- inflating the balloon in a first direction within the vertebral body to create a first void within the cancellous bone;
- deflating the balloon;
- without removing the balloon from the vertebral body, orienting the balloon in a second direction within the vertebral body;
- re-inflating the balloon while oriented in the second direction to enlarge the first void;
- withdrawing the balloon from the vertebral body;
- injecting cement into the void.
A method of kyphoplasty comprising the steps of:
- providing a kyphoplasty balloon catheter comprising a catheter tube and a balloon disposed on the distal end of the catheter tube;
- wherein the catheter tube is characterized by a proximal end and a distal end, a lumen extending therethrough, and a long central axis corresponding to the center of the lumen;
- the balloon, disposed on the distal end of the catheter tube, is characterized by a long axis, a width axis measured from the catheter tube and perpendicular to the long central axis of the catheter tube, and a height axis displaced from the long central axis of the catheter tube and perpendicular to the long central axis of the catheter tube and the long axis of the balloon, wherein the long axis of the balloon, when inflated, is displaced from the long axis of the catheter tube, said balloon in fluid communication with the lumen of the catheter tube;
- inserting the catheter tube distal end within the vertebral body, to position the balloon inside the cortical shell of the vertebral body and amidst the cancellous bone of the vertebral body such that the long axis of the catheter tube is proximate a lateral area of the vertebral body, and the balloon is expandable toward a medial area of the vertebral body, with the width axis disposed on a first radial line relative to the catheter tube from the catheter tube central axis toward the medial area of the vertebral body, said radial line lying in a first plane transecting the vertebral body;
- inflating the balloon within the vertebral body, inside the trabecular/cancellous bone, such that the balloon expands away from the long axis of the catheter tube and into an area of the cancellous bone medial to the catheter tube, to create an intraosseous cavity medial to the distal end of the catheter tube and centered on the first transverse cross section of the vertebral body;
- deflating the balloon;
- thereafter, without withdrawing the balloon or catheter tube;
- rotating the catheter tube to align the width axis and radial line along a second plane transecting the vertebral body;
- inflating the balloon to enlarge the intraosseous cavity centered on the second transverse cross section, or create a second intraosseous cavity centered on the second transverse cross section.
A kyphoplasty balloon catheter comprising:
- a catheter tube, said catheter tube having a proximal end and a distal end, a lumen extending therethrough, and a long central axis corresponding to the center of the lumen, said catheter tube having a side facing aperture in a side aperture segment near the distal end of the catheter tube, with a partial cylinder portion opposite the side aperture;
- a balloon disposed on the distal end of the catheter tube, proximate the side-facing aperture, said balloon characterized by a long axis corresponding to the long central axis of the catheter tube, a width axis measured from the catheter tube and perpendicular to the long central axis of the catheter tube, and a height axis displaced from the long central axis of the catheter tube and perpendicular to the long central axis of the catheter tube and the long axis of the balloon, said balloon having a small cross-section uninflated configuration in which it fits within the side aperture segment of the catheter tube;
- said balloon having a large cross-section inflated configuration in which it extends from the side aperture segment of the catheter tube, extending radially away from the side aperture in a direction opposite the partial cylinder portion;
- wherein the long axis of the balloon, when inflated, is displaced from the long axis of the catheter tube;
- said balloon in fluid communication with the lumen of the catheter tube.
Dependencies are inferred from the claim text.