Heart valve repair using suture knots
Inventors
Gammie, James S. • Patel, Rahul • Ghoreishi, Mehrdad
Assignees
University of Maryland Baltimore
Publication Number
US-12245761-B2
Publication Date
2025-03-11
Expiration Date
2032-06-22
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Abstract
A tissue anchor deployment device includes a needle having a slotted portion including a longitudinal slot that runs from a distal end of the needle and a suture having a first coil portion including a plurality of turns that wrap around a first portion of the slotted portion of the needle, a second coil portion including a plurality of turns that wrap around a second portion slotted portion of the needle that is proximal to the first portion of the slotted portion of the needle, and an internal coupling portion that runs within the first coil portion and the second coil portion and couples a distal end of the first coil portion to a proximal end of the second coil portion.
Core Innovation
The invention provides methods and devices for performing minimally invasive cardiac valve repairs, particularly targeting the mitral and tricuspid valves. The fundamental innovation involves a shafted instrument configured to access the heart through a small incision at or near the apex, enabling repair procedures on a beating heart without the need for sternotomy or cardiopulmonary bypass. The procedure employs real-time echo guidance for precise placement and length adjustment of artificial chordae (neochords) constructed from PTFE or similar materials.
One significant embodiment of the device includes an instrument with stabilizers and needles designed to grasp and penetrate valve leaflets, allowing for accurate suture delivery and anchoring. Advanced features such as a resilient element or balloon tip minimize unintended tissue damage during deployment. The device allows for withdrawal of a needle to leave a suture or expansile element in place, forming secure anchoring knots or loops above or within the leaflet.
The prior art problem addressed by this invention is that conventional mitral and tricuspid valve repair techniques are invasive, labor-intensive, and technically demanding, often requiring open-heart surgery and cardiac arrest, which complicate precise chordal length determination. The new method seeks to overcome these limitations by facilitating less invasive, beating-heart repairs with real-time adjustment and secure anchoring of artificial chordae, minimizing operative risk and improving procedural outcomes.
Claims Coverage
The patent claims one primary inventive feature covering a heart valve repair device with a unique combination of stabilizers and delivery mechanisms.
Grasping and stabilizing a valve leaflet with opposing stabilizers for precise suture delivery
The device comprises a shafted instrument designed to be inserted between heart valve leaflets. It includes: - A first stabilizer that extends from the shafted instrument to contact one side of a targeted leaflet. - A second stabilizer that extends to contact the opposite side of the leaflet and can be advanced toward the first stabilizer while the first stabilizer remains stationary relative to the shaft. - A needle disposed within the instrument, configured to be ejected and penetrate the leaflet after the stabilizers grasp and stabilize it, with the second stabilizer forming an angle of at least 50 degrees relative to the shaft. Additional aspects covered in dependent claims (but not independently claimed) include the use of snares for suture capture, angles of stabilizers, injection of sutures, and specific orientation for valve and stabilizer positioning.
The main inventive feature centers on a minimally invasive heart valve repair device that utilizes cooperating stabilizers and a needle delivery system to securely grasp and suture valve leaflets. This enables accurate and stable delivery of artificial chordae for valve repair.
Stated Advantages
Enables minimally invasive, beating-heart mitral and tricuspid valve repair without requiring sternotomy or cardiopulmonary bypass.
Allows real-time, echo-guided chordal length adjustment to optimize valve function during the procedure.
Reduces technical complexity and labor intensity compared to conventional open-heart surgical techniques.
Improves accuracy in securing artificial chordae of correct length and position, thus producing a competent valve.
Documented Applications
Mitral valve repair using minimally invasive, beating-heart procedures with artificial chordae implantation.
Tricuspid valve repair employing similar minimally invasive techniques and device operation.
Application in any procedure requiring penetration of tissue and formation of a knot or anchor on the far side of the tissue.
Edge-to-edge (Alfieri) repair by deploying devices on separate leaflets and joining them.
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