Patent Application
20230048179
The present invention relates generally to the field of surgery, and more specifically, to repair of a mitral valve.
The heart has four valves that keep blood flowing in the correct direction. The valves include the mitral valve, tricuspid valve, pulmonary valve and aortic valve. Each valve has flaps (leaflets or cusps) that open and close once during each heartbeat. Sometimes, the valves don't open or close properly, disrupting the blood flow through your heart to your body.
The mitral valve lies between the left atrium and the left ventricle. Normally, the mitral valve prevents blood flowing back into the left atrium from the left ventricle. When the mitral valve becomes leaky, it's called mitral valve regurgitation. Mitral valve regurgitation is a condition in which the mitral valve leaflets do not close tightly, allowing blood to flow backward through the mitral valve each time the left ventricle contracts. A leaking mitral valve allows blood to flow in two directions during the contraction. Some blood flows from the ventricle through the aortic valve and some blood flows back into the atrium. Leakage can increase blood volume and pressure in the left atrium. The increased pressure can increase pressure in the veins leading from the lungs to the heart (pulmonary veins). If regurgitation is severe, increased pressure may result in congestion (or fluid build-up) in the lungs. Because of this, the heart has to work harder than it should to get blood out to the body.
Accordingly, there is a need for systems and methods that provide solutions to repair mitral valve regurgitation. The present invention is directed toward systems and methods for treating these problems.
The present invention describes systems and methods for treating mitral valve regurgitation. The treatment includes a systems and method of modifying the mitral valve by attaching a device to each leaflet and pulling them toward each other to stop mitral valve regurgitation.
The present invention describes systems and methods for treating mitral valve regurgitation. The treatment includes a systems and method of modifying the mitral valve by attaching a device to each leaflet and pulling them toward each other to stop mitral valve regurgitation.
A therapy catheter initially grasps the leaflets and a therapy catheter needle is used to puncture through the leaflets. A therapy catheter is used to deliver leaflet anchors with tethers to the leaflets. The leaflet anchors are then attached to the leaflets and pulls the leaflets toward each other. The leaflets are fixed in the desired position.
The steps include a therapy catheter directed to a first mitral valve leaflet. Through a double steerable sheath system. The “outer sheath”/transseptal sheath is placed across the intra-atrial septum from the RA to the LA. The “inner steerable”/guiding catheter is placed through the outer sheath and deflected to set a trajectory to the target location for the leaflet anchor.
The therapy catheter, internal to the inner steerable, depth is adjusted and the first leaflet is grasped.
The therapy catheter includes a cannulated needle used to puncture the first leaflet.
A first leaflet anchor and first tether are then delivered through the cannulated needle to the distal/LV side of the first leaflet. The first anchor then expands and contacts the distal/LV side of the first leaflet. The first tether is exposed as the catheter is removed.
A second leaflet anchor is delivered to the second leaflet. The second tether is exposed.
The first and second tethers are expose through the outer steerable catheter at the groin are inserted into the “knot replacement” tool.
The knot replacement is positioned at the leaflet, the tethers are tensioned, and the knot replacement is engaged and released, leaving the tethers exposed at the groin.
The Tether Cutting Catheter follows the tethers to the knot replacement tool and are cut.
The therapy catheter initially grasps the leaflets and a therapy catheter needle is used to puncture through the leaflet. A therapy catheter is used to deliver leaflet anchors (buttons) with tethers to the leaflets. The leaflet anchors are then attached to the leaflets and pulls the leaflets toward each other, creating a coaptation area for the 2 leaflets. Once the leaflets are in the desired position. The is directed to the leaflet anchor (button) targeted location.
The Therapy Catheter depth is adjusted and the leaflet is grasped.
The Therapy Catheter needle is punctured through the leaflet to the Left Ventricle side of the leaflet.
The leaflet button is delivery and the tether is exposed as the Catheter is removed.
An opposing leaflet anchor is delivery and the tether is exposed.
The two exposed tethers exiting from the groin sheath are inserted into the “knot replacement” tool.
The knot replacement is positioned at the leaflet, the tethers are tensioned, and the knot replacement is engaged and released
The Tether Cutting Catheter follows the tethers to the knot replacement tool and are cut
Blood enters the right atrium 15 from the superior vena cava 50 and the inferior vena cava 55 blood vessels. The blood flows into the right atrium 15, through the tricuspid valve 40 into the right ventricle 20. Blood then flows from the right ventricle 20 into the pulmonary arteries to the lungs. Once through the lungs, the blood flows through the pulmonary veins back to the heart and into the left atrium 25. The blood from the left atrium 25 flows through the mitral valve 45 into the left ventricle 30 and out of the heart through the aortic valve to the ascending aorta.
The needle 220 is advanced through the leaflet and the integrated therapy catheter 205 then delivers a first leaflet anchor 300 having an attached tether 305 through the puncture in the first leaflet 45a. The first leaflet anchor 300 expands or unfolds and contacts a distal side of the first leaflet 45a.
After the first leaflet anchor 300 is secured, the integrated therapy catheter 205 is withdrawn from the first leaflet 45a, shown in
The integrated therapy catheter 205 then delivers a second leaflet anchor 310 having a second tether 315 through the puncture in the second leaflet 45b. The second leaflet anchor 310 is expanded or unfolds and contacts the distal side of the second leaflet 45b.
After the second anchor 310 is secured, the integrated therapy catheter 205 is withdrawn from the second leaflet 45b, shown in
The integrated therapy catheter 205 is then withdrawn from the lumen of the outer steerable catheter 100. After withdrawal, the proximal ends of first and second tethers 305a, 315a extend from the proximal end 110 of the lumen of the outer steerable catheter 100, shown in
The outer steerable catheter 100 is then withdrawn from the body. If a hole in the septum needs to be repaired, an ASD closure device may be used to close the hole.
A cannulated needle 220 is positioned within the proximal body portion 215 is configured to extend distally through a needle lumen 225 in the distal clamp portion 210.
Once the leaflet 45a, 45b is punctured, a leaflet anchor 300, 310 with a tether 305, 315 is delivered through the cannulated needle 220 to the distal side of the leaflet 45a, 45b. The cannulated needle 220 is then withdrawn and the distal clamp portion 210 extends distally to release the leaflet 45a, 45b. As then integrated therapy catheter 205 is removed in a downward direction and the tether moves up through the tether slot 230 and the leaflet anchor 300, 310 and tether 305, 315 stays attached to the leaflet 45a, 45b.
The leaflet anchor self-expands to a size larger than the puncture and engages the distal side of the leaflet. The tether extends proximally through the puncture and out of the body to be grasped during the procedure.
The “knot replacement” tool 400 includes a locking cap 405, a locking screw 410, a shaft coupler 415 and a delivery shaft 420.
The locking cap 405 is cylindrical in shape with a cylindrical cavity open on a proximal end 405a and closed on a distal end 405b. The cavity 425 includes an internal threaded portion 430 and the closed end includes first and second tether locking cap holes, 435a, 435b sized to receive the first and second tethers 305, 315.
The locking screw 410 includes an external threaded portion 440 and a cylindrical cavity that is open on a proximal end 410a and closed on a distal end 410b. The closed end 410b includes first and second tether locking screw holes 445a, 445b sized to receive the first and second tethers 45a, 45b. The distal end 410b is configured to be inserted into the open proximal end 405a of the locking cap 405 and the external threaded portion 440 configured to rotatingly engage with the internal threads 430 so that the locking screw 410 may be screwed into the locking cap 405.
During use, the first and second tethers 305, 315 are inserted through both the first and second tether locking cap holes 435a, 435b and the first and second tether locking screw holes 445a, 445b. As the locking screw 410 is rotated in the locking cap 405, the first and second tether locking screw holes, 445a, 445b are also rotated with respect to the includes first and second tether locking cap holes, 435a, 435b. During this rotation, the first tether 315 and second tether 315 are twisted around each other and are locked in place.
The shaft coupler 415 and a delivery shaft 420 are components of a connect/disconnect feature of the “knot replacement” tool 400 that are configured to couple the shaft 415 with the locking screw 410. The coupling of the shaft 420 allows torque to be applied to the locking screw 410. The design also has zero release force when the shaft 420 is uncoupled from the shaft coupler 415. This provides the ability to torque the locking screw 410 and screw the locking screw 410 into the locking cap 405. The shaft 420 can then be uncoupled without disrupting the locking screw 410 and the locking cap 405 when they are locked together.
The delivery shaft 420 includes a distal end 420a with engagement arms 465 having springlike properties that allow them to deflect and spring back to their original position. The distal end 420a is configured to be inserted into the into the central opening 450 of the shaft coupler 415.
The distal end of the delivery shaft 420 is sized for insertion into the central opening 450. During insertion, a curved distal portion of the engagement arms 465 contacts the shaft coupler 415 and deflects inwardly into the central opening 450 until the engagement arms 465 line up with the slots 460. Then the spring arms 465 return to their original shape and engage and lock in the slots 460. When the engagement arms 465 are coupled with the slots 460, the locking screw 410 may be rotated or torqued in the locking cap 405.
The cutter 500 includes an outer cutter body 505 coupled to a braided polyimide shaft 510 and a distal stopper 515. The outer cutter body is a cylindrical tube with a side opening 520. An inner cutter body 525 is positioned within the outer cutter body 505. The inner cutter body 525 is a cylindrical tube with a side opening 530. The side openings 520 and 530 of the outer cutter body 505 and the inner cutter body 520 are positioned to provide an opening to a center lumen 555. A proximal stopper 535 which directs the tether ends through the outer and inner cutter bodies aligned side openings 520, 530. It is coupled to the distal end of the inner cutter body 525. A high torque flexible cable or torque shaft 540 is slidably positioned within the lumen of the components. The high torque cable 540 is used to rotate a thread 545 that drives the inner cutter body 525 in an axial direction 550 to scissor cut the tethers 305, 315 between the sharp edges of the inner cutter opening 530 and outer cutter opening 520. The distal end of the flexible cable 540 is positioned proximally of the side openings 520 and 530 during delivery. Once the cutter 500 is in the desired position, the tethers 305, 315 are tensioned, and the flexible cable 540 is rotated to drive the threaded cutter mechanism that moves the inner cutter 525 relative to the outer cutter 505 to cut the first and second tethers 305, 315.
Example embodiments of the methods and systems of the present invention have been described herein. As noted elsewhere, these example embodiments have been described for illustrative purposes only and are not limiting. Other embodiments are possible and are covered by the invention. Such embodiments will be apparent to persons skilled in the relevant art(s) based on the teachings contained herein. Thus, the breadth and scope of the present invention should not be limited by any of the above-described exemplary embodiments but should be defined only in accordance with the following claims and their equivalents.
This application claims priority to U.S. Provisional Patent Application No. 63/233,138, filed Aug. 13, 2021, the entire disclosure of which is incorporated by reference herein.
| Number | Date | Country | |
|---|---|---|---|
| 63233138 | Aug 2021 | US |
