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公开(公告)号:CA2285233A1
公开(公告)日:1998-10-08
申请号:CA2285233
申请日:1998-04-02
Applicant: BAXTER INT
Inventor: HUYNH VAN LE , GUO XIAOMING G , LAM HUNG LY , ZHOU JIAMBO , KAFESJIAN RALPH , ROMERO CARLOS M , NGUYEN THAN
Abstract: Heart valve leaflet selection methods and apparatuses which subject individual leaflets to loads and measure the resulting deflection to more reliably group leaflets of similar physical characteristics for later assembly in prosthetic heart valves. The deflection testing may be accomplished using a variety of test set ups which are designed to impart a load on the leaflet which simulates the actual loading within a heart valve. The results from a number of deflection tests are used to categorize individual leaflets, which data can be combined with other data regarding the characteristics of the leaflet to better select leaflets for assembly into a multi-leaflet heart valve. In one embodiment, the deflection test is combined with an intrinsic load test, and leaflets having similar deflection and intrinsic load values used in the same heart valve. One apparatus for testing the leaflets includes a frame for securing the arcuate cusp of the leaflet while the straight coapting edge remains free, to simulate the actual leaflet mounting configuration within the heart valve prosthesis. The frame may include a lower portion having a recess for the leaflet and plurality of receptor holes around the peripheral edge of the recess, and an upper portion having a plurality of needles which extend downward through the leaflet and into the receptor holes and secure the edges of the leaflet.
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公开(公告)号:DE69110880T2
公开(公告)日:1995-12-21
申请号:DE69110880
申请日:1991-03-26
Applicant: BAXTER INT
Inventor: WIETING DAVID , NGUYEN THAN , STOBIE ROBERT , LAM HUNG , KAFESJIAN RALPH
IPC: A61F2/24
Abstract: A mechanical heart valve having one or more leaflets pivotally fitted in a substantially cylindrical shaped valve body formed from a resiliently deformable material. A stiffening member formed from substantially nonresilient material fit about the valve body exterior wall to provide structural integrity to the valve body. Stresses which are normally applied to the heart valve body during the opening and closing of the valve are absorbed or cushioned by the incorporation of a rubber-like body between the stiffening member and the retainer member. Further cushioning is provided by incorporating another rubber-like body in the sewing ring. This second body extends out from the exterior surface of the valve body. Finally, a length of fabric is positioned about the retainer and shock absorbing bodies. This design provides a precisely calibrated rotational torque which allows for optimum orientation of the leaflets by the implanting surgeon.
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公开(公告)号:AU727254B2
公开(公告)日:2000-12-07
申请号:AU6790798
申请日:1998-04-02
Applicant: BAXTER INT
Inventor: NGUYEN THAN , LAM HUNG LY , ZHOU JIANBO , ROMERO CARLOS M , KAFESJIAN RALPH , GUO XIAOMING G , HUYNH LE VAN
Abstract: A multi-leaflet bioprosthetic heart valve comprising a plurality of leaflets, wherein each of the leaflets has a measured deflection response within 0.030. inches of the other leaflets upon application of a load sufficient to stress each of the leaflets between 300 and 600 kPa.
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公开(公告)号:CA2284941C
公开(公告)日:2000-05-16
申请号:CA2284941
申请日:1998-03-25
Applicant: BAXTER INT
Inventor: NGUYEN THAN , KAFESJIAN RALPH , LAM HUNG LY , GUO XIAOMING G , HUYNH VAN LE
Abstract: Improved, adaptable tissue-type heart valves and methods for their manufacture are disclosed wherein a dimensionally stable, pre-aligned tissue leaflet subassembly is formed and its peripheral edge clamped between and attached to an upper shaped wireform and a lower support stent. A variety of adaptable structural interfaces including suture rings, flanges, and conduits may be attached to the support stent with or without an outlet conduit disposed about the wireform to provide a tissue-type heart valve adaptable for use in either a natural heart or in mechanical pumping devices.
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公开(公告)号:DE69110880D1
公开(公告)日:1995-08-03
申请号:DE69110880
申请日:1991-03-26
Applicant: BAXTER INT
Inventor: WIETING DAVID , NGUYEN THAN , STOBIE ROBERT , LAM HUNG , KAFESJIAN RALPH
IPC: A61F2/24
Abstract: A mechanical heart valve having one or more leaflets pivotally fitted in a substantially cylindrical shaped valve body formed from a resiliently deformable material. A stiffening member formed from substantially nonresilient material fit about the valve body exterior wall to provide structural integrity to the valve body. Stresses which are normally applied to the heart valve body during the opening and closing of the valve are absorbed or cushioned by the incorporation of a rubber-like body between the stiffening member and the retainer member. Further cushioning is provided by incorporating another rubber-like body in the sewing ring. This second body extends out from the exterior surface of the valve body. Finally, a length of fabric is positioned about the retainer and shock absorbing bodies. This design provides a precisely calibrated rotational torque which allows for optimum orientation of the leaflets by the implanting surgeon.
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公开(公告)号:CA2079339A1
公开(公告)日:1991-09-30
申请号:CA2079339
申请日:1991-03-26
Applicant: BAXTER INT
Inventor: WIETING DAVID W , NGUYEN THAN , STOBIE ROBERT , LAM HUNG L , KAFESJIAN RALPH
IPC: A61F2/24
Abstract: A mechanical heart valve (11) having one or more leaflets (17) pivotally fitted in a substantially cylindrical shaped valve body (19) formed from a resiliently deformable material. A stiffening member (25) formed from substantially nonresilient material fit about the valve body exterior wall to provide structural integrity to the valve body (19). Stresses which are normally applied to the heart valve body during the opening and closing of the valve are absorbed or cushioned by the incorporation of a rubber-like body (26) between the stiffening member (25) and the retainer member (33). Further cushioning is provided by incorporating another rubber-like body (28) in the sewing ring (13). This second body extends out from the exterior surface of the valve body. Finally, a length of fabric (15) is positioned about the retainer (33) and shock absorbing bodies (26). This design provides a precisely calibrated rotational torque which allows for optimum orientation of the leaflets by the implanting surgeon.
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公开(公告)号:CA2285233C
公开(公告)日:2007-06-26
申请号:CA2285233
申请日:1998-04-02
Applicant: BAXTER INT
Inventor: ZHOU JIAMBO , LAM HUNG LY , NGUYEN THAN , KAFESJIAN RALPH , GUO XIAOMING G , HUYNH VAN LE , ROMERO CARLOS M
Abstract: Heart valve leaflet selection methods and apparatuses which subject individual leaflets to loads and measure the resulting deflection to more reliably group leaflets of similar physical characteristics for later assembly in prosthetic heart valves. The deflection testing may be accomplished using a variety of test set ups which are designed to impart a load on the leaflet which simulates the actual loading within a heart valve. The results from a number of deflection tests are used to categorize individual leaflets, which data can be combined with other data regarding the characteristics of the leaflet to better select leaflets for assembly into a multi-leaflet heart valve. In one embodiment, the deflection test is combined with an intrinsic load test, and leaflets having similar deflection and intrinsic load values used in the same heart valve. One apparatus for testing the leaflets includes a frame for securing the arcuate cusp of the leaflet while the straight coapting edge remains free, to simulate the actual leaflet mounting configuration within the heart valve prosthesis. The frame may include a lower portion having a recess for the leaflet and plurality of receptor holes around the peripheral edge of the recess, and an upper portion having a plurality of needles which extend downward through the leaflet and into the receptor holes and secure the edges of the leaflet.
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公开(公告)号:CA2284941A1
公开(公告)日:1998-10-08
申请号:CA2284941
申请日:1998-03-25
Applicant: BAXTER INT
Inventor: NGUYEN THAN , KAFESJIAN RALPH , LAM HUNG LY , GUO XIAOMING G , HUYNH VAN LE
Abstract: Prosthetic heart valve suture rings having a suturable annulus of a compliant internal member and a cloth covering. Three evenly spaced upwardly opening depressions formed on an internal circumference of the suturable annulus receive downwardly-directed cusps of a stent structure of the heart valve. The suture ring may include a silicone sponge waffle annulus having a walled lip on an inner circumference thereof. The lip is contoured to include the three depressions, and a ring washer mounts on the annulus surrounding the walled lip for added stiffness.
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公开(公告)号:CA2247199A1
公开(公告)日:1997-09-12
申请号:CA2247199
申请日:1997-03-03
Applicant: BAXTER INT
Inventor: HU CAN B , KAFESJIAN RALPH , NGUYEN-THIEN-NHON DIANA , MYERS KEITH E
Abstract: Nonpolymeric epoxy compounds for cross-linking biological tissues and bioprosthetic materials prepared thereby. The nonpolymeric epoxy compounds of the present invention have the general structural formula: R1-CH2-O-X-O-CH2-R2 wherein, X is either (a) a straight chain aliphatic hydrocarbon having at least four (4) and no more than five (5) carbon atoms bonded directly to one another, said straight chain aliphatic hydrocarbon being devoid of side branches and having terminal carbon atoms at either end therof, the terminal carbon atoms at the ends of said straight chain aliphatic hydrocarbon being bonded to the oxygen atoms shown in the foregoing general formula, (b) a substituted aromatic hydrocarbon, or (c) a substituted or unsubstituted cycloaliphatic hydrocarbon; and, wherein at least one of the terminal groups R1, or R2 is an epoxy group and the other of said terminal groups R1 or R2 is either (a) an epoxy group, (b) an aldehyde group, (c) an isocyanate group, or (d) a thiocyanate group. One preferred cross-linking agent of the above general formula is 1,4, butanediol diglycidyl ether. The cross-linking agents of the present invention are preferably utilized in the absence of other chemical compounds (e.g., congeners, molecular fragments, impurities) which would react with either collagen or the cross-linking agent of the present invention.
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