Method of reversibly closing a septal defect
First Claim
1. A method of closing an intravascular defect in a body, the method comprising the steps of:
- a) providing an apparatus for closing an intravascular defect in a body, the apparatus comprising;
i) a reversibly configured defect closure device that comprises a first end, a second end, a center portion and having a delivery configuration and a plug configuration,ii) a delivery catheter; and
iii) an intralumen mechanical mechanism associated with the delivery catheter for remotely operating the closure device between the two configurations;
b) delivering the apparatus in the delivery configuration by means of the catheter to an area having an intravascular defect;
c) positioning the device in the defect;
d) operating the intralumen mechanical mechanism to cause the closure device to change from the delivery configuration to the plug configuration to thereby fit securely into the defect, ande) removing the catheter delivery means and intralumen mechanical mechanism.
2 Assignments
0 Petitions
Accused Products
Abstract
A catheter delivered device to close a septal defect, the device comprising a cylindrical shaft of metal or polymeric material with concentric parallel cuts through the wall of the device which create flattened support struts. The center of the support struts move radially away from the axis in a hinge like fashion in response to the movement of the device'"'"'s proximal and distal ends toward the center of the device. This movement is reversibly effected through mechanical means. The device can be coated with growth factors, mitogenic factors or other determinants which can improve tissue growth such that tissue ingrowth can occur over a period of time. The catheter itself may be an ultrasonic imaging catheter.
839 Citations
8 Claims
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1. A method of closing an intravascular defect in a body, the method comprising the steps of:
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a) providing an apparatus for closing an intravascular defect in a body, the apparatus comprising; i) a reversibly configured defect closure device that comprises a first end, a second end, a center portion and having a delivery configuration and a plug configuration, ii) a delivery catheter; and iii) an intralumen mechanical mechanism associated with the delivery catheter for remotely operating the closure device between the two configurations; b) delivering the apparatus in the delivery configuration by means of the catheter to an area having an intravascular defect; c) positioning the device in the defect; d) operating the intralumen mechanical mechanism to cause the closure device to change from the delivery configuration to the plug configuration to thereby fit securely into the defect, and e) removing the catheter delivery means and intralumen mechanical mechanism.
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2. A method of closing an intravascular defect in a body, the method comprising the steps of:
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a) providing an apparatus for closing an intravascular defect in a body, the apparatus comprising; i) a reversibly configured defect closure device that comprises a first end, a second end, a center portion and having a delivery configuration and a plug configuration, ii) a delivery catheter; and iii) an intralumen mechanical mechanism associated with the delivery catheter for remotely operating the closure device between the two configurations; b) delivering the apparatus in the delivery configuration by means of the catheter to an area having a defect; c) positioning the device in the defect; d) operating the intralumen mechanical mechanism, to cause the closure device to change from the delivery configuration to the plug configuration to thereby fit securely into the defect spanning both sides thereof; e) removing the catheter delivery means and intralumen mechanical mechanism; and
optionallyf) reinserting and delivering a catheter and remotely operate intralumen mechanical mechanism to the area of the defect to operably contact the device; g) operating the intralumen mechanical mechanism to change the device from the plug configuration to the delivery configuration; h) repositioning the defect closure device in the defect; and i) operating the intralumen mechanical mechanism to cause the defect closure device to resume its plug configuration in the defect, again causing the defect to be reversibly closed/plugged, and j) removing the catheter delivery means and intralumen mechanical mechanism.
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3. A method of closing an intravascular defect in a body, the method comprising the steps of:
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a) providing an apparatus for closing an intravascular defect in a body, the apparatus comprising; i) a reversibly configured defect closure device that comprises a first end, a second end, a center portion and having a delivery configuration and a plug configuration, ii) a delivery catheter; and iii) an intralumen mechanical mechanism associated with the delivery catheter for remotely operating the closure device between the two configuration; b) delivering the apparatus in the delivery configuration by means of the catheter to an area having a defect; c) positioning the device in the defect; d) operating the intralumen mechanical mechanism, to cause the closure device to change from the delivery configuration to the plug configuration to thereby fit securely into the defect spanning both sides thereof; e) repositioning a catheter and remotely operable intralumen mechanical mechanism to the area of the defect to operably contact the device; f) operating the intralumen mechanical mechanism to change the device from the plug configuration to the delivery configuration, and g) removing the catheter, intralumen mechanical mechanism and the defect closure device from the defect.
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4. A method of reversibly closing an intravascular defect in a body, the method comprising the steps of:
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a) providing an apparatus for reversibly closing an intravascular defect in a body, the apparatus comprising; i) a reversibly configured defect closure device that is unitary in construction and comprises a first end, a second end, a center portion and having a delivery configuration and a plug configuration, the device also including a cylindrical shaft having an axis therethrough and a plurality of cuts therethrough parallel to the axis; ii) a catheter delivery means; and iii) an intralumen mechanical mechanism located in the catheter delivery means for operating the closure device between the two configurations; b) delivering the apparatus to an area having a defect; c) positioning the center portion of the shaft of the device in the defect; d) pulling the shaft in a proximal direction relative to the catheter by means of the intralumen mechanical mechanism, thereby creating at least two flattened support struts which move radially away from the axis in a hinge like fashion causing the closure device to plug the defect; e) removing the catheter delivery means and intralumen mechanical mechanism; and
optionally at a later time;f) inserting and positioning a catheter and intralumen mechanical mechanism at the area of the defect in operable contact with the defect closure device; g) removing the defect closure device from the defect by moving the struts of the defect closure device radially toward the axis by means of the intralumen mechanical mechanism thereby causing the defect closure device to approach or resume its delivery configuration; and h) withdrawing the apparatus and device from the body.
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5. A method of closing an intravascular defect in a body, the method comprising the steps of:
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a) providing an apparatus for closing an intravascular defect in a body, the apparatus comprising; i) a reversibly configured defect closure device that comprises a first end, a second end, a center portion and having a delivery configuration and a plug configuration, the device further comprising an elongate shaft having an axis therethrough and a plurality of concentric parallel cuts therethrough; ii) a delivery catheter; and iii) an intralumen mechanical mechanism associated with the catheter for operating the closure device between the two configurations; b) delivering the apparatus in the delivery configuration to an area having a defect by means of the catheter; c) inserting the shaft of the device through the defect and positioning it therein; d) pulling on the shaft by means of the intralumen mechanical mechanism, causing the closure device to assume the plug configuration and plug the defect; e) removing the catheter and intralumen mechanical mechanism; f) reinserting a catheter and intralumen mechanical mechanism to the area of the defect and operably contacting the device; g) operating the intralumen mechanism to reconfigure the device to the delivery configuration and removing the defect closure device from the defect; h) repositioning the defect closure device in the defect; and i) causing the defect closure device to resume its plug configuration by operation of the intralumen mechanism again causing the defect to be reversibly plugged; and j) removing the catheter and intralumen mechanical mechanism.
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6. A method of reversibly closing an intravascular defect in a body, the method comprising the steps of:
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a) providing an apparatus for closing a defect in a body, the apparatus comprising; i) a reversibly deformable defect closure device that is unitary in construction and comprises a first end, a second end, a center portion and having a delivery configuration and a plug configuration, the device including a cylindrical shaft having an axis therethrough and a plurality of cuts therethrough parallel to the axis; ii) a catheter delivery means; and iii) an intralumen mechanical mechanism associated with the catheter for deforming the closure device between the two configurations; b) delivering the apparatus to an area having a defect; c) positioning the center portion of the shaft of the device in the defect; d) pulling the first and second ends of the shaft toward the center portion thereof, by means of the intralumen mechanical mechanism thereby forming at least two flattened support members which move radially away from the axis in a hinge like fashion causing the closure device to assume the plug configuration and plug the defect; e) removing the catheter delivery means and intralumen mechanical mechanism; and
optionally at a later timef) inserting and delivering a catheter and intralumen mechanical mechanism to the area of the defect to operably contact the device; g) removing the defect closure device from the defect by operating the intralumen mechanical mechanism to deform the device thereby causing the device to resume its delivery configuration; and h) withdrawing the apparatus and device from the body.
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7. A method of closing an intravascular defect in a body, the method comprising the steps of:
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a) providing an apparatus for closing an intravascular defect in a body, the apparatus comprising; i) a reversibly configured defect closure device that comprises a first end, a second end, a center portion and having a delivery configuration and a plug configuration, ii) a delivery catheter; and iii) an intralumen mechanical mechanism associated with the delivery catheter for remotely operating the closure device between the two configurations; b) delivering the apparatus in the delivery configuration by means of the catheter to an area having a defect; c) positioning the device in the defect; d) operating the intralumen mechanical mechanism, to cause the closure device to change from the delivery configuration to the plug configuration to thereby fit securely into the defect spanning both sides thereof; e) operating the intralumen mechanical mechanism to change the device from the plug configuration to the delivery configuration; and f) removing the catheter, intralumen mechanical mechanism and the defect closure device from the defect.
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8. A method of closing an intravascular defect in a body, the method comprising the steps of:
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a) providing an apparatus for closing an intravascular defect in a body, the apparatus comprising; i) a reversibly configured defect closure device that comprises a first end, a second end, a center portion and having a delivery configuration and a plug configuration, ii) a delivery catheter; and iii) an intralumen mechanical mechanism associated with the delivery catheter for remotely operating the closure device between the two configurations; b) delivering the apparatus in the delivery configuration by means of the catheter to an area having a defect; c) positioning the device in the defect; d) operating the intralumen mechanical mechanism, to cause the closure device to change from the delivery configuration to the plug configuration to thereby fit securely into the defect spanning both sides thereof; e) operating the intralumen mechanical mechanism to change the device from the plug configuration to the delivery configuration; f) repositioning the defect closure device in the defect; g) operating the intralumen mechanical mechanism, to cause the closure device to change from the delivery configuration to the plug configuration to thereby fit securely into the defect spanning both sides thereof; h) operating the intralumen mechanical mechanism to change the device from the plug configuration to the delivery configuration; and f) removing the catheter, intralumen mechanical mechanism and the defect closure device from the defect.
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Specification