Edwards Lifesciences Corporation

Baxter International Inc.

Other

Robert Stobie

Ralph Kafesjian

Diana Nguyen-Thien-Nhon

Jerry L Jackman

Cuong Ton-That

C Roger Ekholm

Steve Newborg

Hung Ly Lam

George Xinsheng Guo

Adrian Benton James

Andrzej Skoskiewicz

Robert Ian Lister

Aaron Ernesto Sklar

Banny Banerjee

Michael N Helmus

Delos M Cosgrove, Iii

Than Nguyen

Myron Howanec, Jr

Hugues Lafrance

David W Wieting

George X Guo

Albert Starr

Roger C Ekholm

Delos M Cosgrove

Myron Jr Howanec

An improved holder and method for implanting a tissue-type prosthetic mitral heart valve that prevents suture looping and ma y also constrict the commissure posts of the valve. An upstanding or shaft member axially positioned on the holder causes the lengths of attachment sutures to extend axially beyond the commissure post tips to create a tent and prevent looping of any of an array of pre-implanted sutures around the tips during deployment of the valve. The shaft member may be axially movable such that it can be initially retracted and then actuated just prior to valve deployment. The shaft member may have notches on its distal tip for capturing the attachment sutures, which are crossed over along the valve axis to ensure engagement by the notches. The attachment sutures may be strands or filaments, or may be wider bands of flexible biocompatible material. If bands are used, they desirably cover the commissure post tips to further help prevent suture looping thereover. The flexible lengths of material extend directly between commissures of the valve, or may extending radially inward from each commissure to a central upstanding member.

Heart valve holder and method for resisting suture looping

An improved holder and method for implanting a tissue-type prosthetic mitral heart valve that prevents suture looping and may also constrict the commissure posts of the valve. An upstanding or shaft member axially positioned on the holder causes the lengths of attachment sutures to extend axially beyond the commissure post tips to create a tent and prevent looping of any of an array of pre-implanted sutures around the tips during deployment of the valve. The shaft member may be axially movable such that it can be initially retracted and then actuated just prior to valve deployment. The shaft member may have notches on its distal tip for capturing the attachment sutures, which are crossed over along the valve axis to ensure engagement by the notches. The attachment sutures may be strands or filaments, or may be wider bands of flexible biocompatible material. If bands are used, they desirably cover the commissure post tips to further help prevent suture looping thereover. The flexible lengths of material extend directly between commissures of the valve, or may extending radially inward from each commissure to a central upstanding member.

A holder for a flexible leaflet prosthetic aortic heart valve that is less bulky than earlier holders and minimizes obstructions to vision and working space around the valve to facilitate implantation thereof. The holder may have a central hub and three outwardly extending legs that connect directly and exclusively to tips of the commissures of the aortic heart valve for better tactile feedback when parachuting and seating the valve in the annulus. The legs are sized so that they do not overlap the commissure tips and therefore afford a better view of the sewing ring adjacent the commissures. The legs may be narrow in the midsection or split into two rails to increase visibility of the valve leaflets. The hub may be vaulted axially upward relative to the outer ends of the legs to further increase visibility of the valve. A more secure engagement between the central hub and a delivery handle is also provided to ensure the holder/handle connection does not become loose during suture placement through the sewing ring and fewer handle revolutions are required to screw in and unscrew the handle from the holder.

Holders for prosthetic aortic heart valves

A simulated heart valve root used for training physicians in techniques of implantation of prosthetic heart valves as well as for more realistically testing the efficacy of prosthetic heart valves. The simulated heart valve root is made of the flexible, tubular body having an inner wall defining an annular ledge within which the prosthetic heart valve is implanted. Discrete nodes or areas of simulated calcification may be provided on the annular ledge. A simulated aortic root includes alternating cusps and commissures with calcification simulated at least at one of the commissures. A tear in the annular ledge may also be provided which simulates a tear that might occur from a valvuloplasty procedure. A reinforcing sleeve may surround the flexible tubular body to provide rigidity or hoop strength thereto. A method of testing includes mounting the simulated heart valve root in a flow conduit, implanting a prosthetic heart valve in the root, applying pulsatile flow to the assembly, and monitoring for leaks. The simulated heart valve root may also be incorporated within a larger simulated heart for use in training physicians to remotely implant prosthetic heart valves.

Simulated heart valve root for training and testing

Anatomical orifice sizers that are optimally proportional to an associated prosthetic device such as a heart valve, and methods of use are provided. The sizers are desirably slightly larger than the rigid mounting diameter of the corresponding heart valve. The heart valve sizer may be cylindrical and have a diameter about 0.3 mm larger than the valve mounting diameter. The sizer preferably has a length of between about 19 mm to 22 mm, and the edges are desirably rounded to a minimum 1 mm radius. The method includes providing a set of cylindrical sizers having varying diameters; sequentially inserting at least two of the sizers through the annulus; measuring the push force needed to pass each sizer through the annulus; selecting a valve corresponding to the sizer for which the measured push force is between about 150 and 300 grams.

Heart valve sizers dimensioned larger than corresponding heart valves

An improved holder, system and method for implanting a tissue-type prosthetic heart mitral valve that constricts the commissure posts of the valve and allows the user to detach the handle of the holder prior to withdrawing the holder itself. The ability to remove the handle allows a surgeon greater access to suturing the prosthetic valve to the mitral annulus. The holder may include two relatively movable plates, one of which attaches to the valve sewing on the inflow end of the valve ring and the other which attaches via sutures to the valve commissures on the outflow end. Separation of the plates places the sutures in tension and constricts the commissures. An adjusting member or adapter is interposed between the handle and holder to enable separation of the two plates and removal of the handle. The adjusting member or adapter may be packaged with the valve and holder combination, or may be sold as a separate unit, possibly with the handle, so that prior art holders can be retrofit. Removable storage and handling clips secure the holder and heart valve assembly within a storage jar during transportation. A kit of a number of identical storage and handling clips and holders for different diameter tissue-type prosthetic heart valves may be provided.

Heart valve holders and handling clips therefor

An improved holder, system and method for implanting a tissue-type prosthetic mitral heart valve that prevents suture looping and may also constrict the commissure posts of the valve. The holder may include two relatively movable plates, one of which attaches to the valve sewing on the inflow end of the valve ring and the other which attaches via sutures or similar expedient to the valve commissures on the outflow end. Separation of the plates places the sutures in tension and constricts the commissures. The sutures may be strands or filaments, or may be wider bands of flexible biocompatible material. If bands are used, they desirably cover the commissure post tips to further help prevent suture looping thereover. The flexible lengths of material extend directly between commissures of the valve, or may extending radially inward from each commissure to a central upstanding member. Desirably, a slide is created by the flexible lengths of material adjacent each commissure post, for example by crossing over suture filaments at or radially inward from the commissure posts. If an upstanding member is used, the lengths of suture extend axially beyond the commissure post tips to create a tent that wards off sutures that otherwise might loop around the tips during advancement of the valve along an array of pre-implanted sutures.

Heart valve holder that resist suture looping

Combination anatomical orifice sizer and heart valve

An improved holder, system and method for implanting a tissue-type prosthetic heart mitral valve that constricts the commissure posts of the valve and allows the user to detach the handle of the holder prior to withdrawing the holder itself. The ability to remove the handle allows a surgeon greater access to suturing the prosthetic valve to the mitral annulus. The holder may include two relatively movable plates, one of which attaches to the valve sewing on the inflow end of the valve ring and the other which attaches via sutures to the valve commissures on the outflow end. Separation of the plates places the sutures in tension and constricts the commissures. An adjusting member or adapter is interposed between the handle and holder to enable separation of the two plates and removal of the handle. The adjusting member or adapter may be packaged with the valve and holder combination, or may be sold as a separate unit, possibly with the handle, so that prior art holders can be retrofit.

Method for retrofitting a heart valve holder

Heart valve holder for constricting the valve commissures and methods of use

Anatomical orifice sizers and methods of orifice sizing

A suture ring for a rotatable artificial heart valve apparatus has a ring member covered by a fabric material. A portion of the fabric material covers a portion of the inner surface of the ring member. At least one protuberance is formed on the inner surface of the ring member so as to mitigate the frictional resistance to rotation which results from compression of the fabric between the suture ring and the heart valve. Thus, desirable rotation of the heart valve relative to the suture ring is assured over a range of thicknesses of the fabric material.

Suture rings for rotatable artificial heart valves

Growing community of inventors

Mission Viejo, CA, United States of America

Robert Stobie