Bioprosthetic heart valve implantation device

• US 5,800,531 A
• Filed: 09/30/1996
• Issued: 09/01/1998
• Est. Priority Date: 09/30/1996
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Baxter International Inc.
• Inventors: Cosgrove, Delos M., Rhee, Richard, Nguyen, Diana
• Primary Examiner(s): Buiz, Michael Powell
• Assistant Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US08/723,420
• Time in Patent Office: 701 Days
• Field of Search: 606/139, 606/148, 623/2, 623/900
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: Y10S 623/90 Stent for heart valve

Abstract

In general, the present invention comprises an holding apparatus for facilitating implantation of a prosthetic heart valve within a mammalian heart. The holding apparatus generally comprises a cage or enclosure having a heart valve prosthesis retention space defined therewith. The proximal end of the holding apparatus is releasably attached to the proximal end of the heart valve prosthesis such that, when the holding apparatus is advanced in a forward direction, a "pulling" force will be exerted upon the proximal end of the prosthesis, rather than a "pushing" force being exerted upon the distal end of the prosthesis. The releasable attachment of the prosthesis to the holding apparatus may be accomplished by any suitable attachment member, and preferably comprises a number of suture threads which are passed through the prosthesis and threaded upon the holding apparatus at location(s) which are easily accessible such that the surgeon may cut the suture threads to effect release of the heart valve prosthesis, during the prosthesis implantation procedure. Also described and claimed are associated methods for utilizing the above-described holding apparatus to effect implantation of a prosthetic heart valve.

Claims

1. A holding apparatus for facilitating the surgical implantation of a heart valve prosthesis of the type having, i) a generally tubular prosthesis body having an inner surface, an outer surface, a proximal end, a distal end, an inflow annulus at the proximal end thereof, an outflow annulus at the distal end thereof, and ii) a plurality of valving members disposed within the prosthesis body to perform a hemodynamic valving function and a sewing ring attached to the inflow annulus to facilitate suturing of the inflow annulus to an endogenous opening, said holding apparatus comprising:

a) a hub member positionable adjacent the distal end of the prosthesis body

b) a plurality of elongate strut members having proximal ends and distal ends which are attached to said distal hub member such that the strut members extend substantially downward therefrom so as to define a hollow prosthesis retention space inboard of said strut members and beneath said hub member;

c) at least one releasable attachment means for releasably holding the prosthesis within said prosthesis retention space such that the proximal inflow end of the prosthesis is connected to the strut members; and

d) a proximal ring member attached to the proximal ends of said strut members, said proximal ring member being attachable about the proximal inflow annulus of the prosthesis such that, when a force is applied in the proximal direction against the distal hub member of the holding apparatus, such force will be transferred through said strut members to said proximal ring member, thereby resulting in the application of a distally directed pulling force which is annularly distributed about the proximal inflow annulus of the prosthesis.

2. The holding apparatus of claim 1, further comprising:

an elongate handle attachable to the distal hub member of the holding apparatus, and extendable in a distal direction therefrom.

3. The holding apparatus of claim 2 wherein said distal hub member has a female retention bore formed therein and wherein said elongate handle member has a distal male member formed thereon, the distal male member of said handle being engageable within the female retention bore of the distal hub member to effect attachment of said handle to said holding apparatus.

4. The holding apparatus of claim 1 wherein:

said proximal ring member is severed at at least two locations such that said proximal ring member may be separated into a plurality of segments; and

,

said strut members being bendable to cause the proximal ring member to separate such that spaces are created between the segments of said ring member.

5. The holding apparatus of claim 1 further comprising:

at least one releasable attachment member for temporarily connecting the inflow annulus at the proximal end of a heart valve prosthesis disposed within said hollow prosthesis retention space, to the proximal ends of the strut members;

said releasable attachment member being manually disconnectable from said prosthesis in a manner which releases the holding apparatus from said prosthesis.

6. The holding apparatus of claim 5 wherein:

said at least one releasable attachment member comprises a suture thread anchored to the holding apparatus and passable through a prosthesis which is disposed within the hollow prosthesis retention space, to releasably attach said prosthesis to said holding apparatus;

a portion of said suture thread being located upon the holding apparatus at a first location which is sufficiently accessible during the implantation procedure to permit cutting of said suture thread at said first location, thereby causing the prosthesis to be disconnected from the holding apparatus such that the holding apparatus may be subsequently extracted and removed, leaving the heart valve prosthesis in place.

7. The holding apparatus of claim 6 wherein said holding apparatus further comprises:

a cutting instrument retention notch formed in said holding apparatus at said first location;

said cutting instrument retention notch being sized to permit a cutting instrument to be inserted thereinto for the purpose of cutting of said suture thread at said first location.

8. The holding apparatus of claim 6 wherein:

a plurality of first suture threads are connected to the proximal ends of the strut members of the holding apparatus and are passed through the inflow annulus at the proximal end of a heart valve prosthesis disposed within the hollow prosthesis retention space of the holding apparatus, to connect the distal ends of the strut members to the inflow annulus of the prosthesis; and

,

a plurality of second suture threads are additionally anchored to the distal hub member of the holding apparatus and are passed through the heart valve prosthesis at locations which are distal to the proximal end of the prosthesis, to effect further connection of the prosthesis to the holding apparatus;

said first suture threads and said second suture threads being passed through said first location and positioned in side-by-side juxtaposition, such that said first suture threads and said second suture threads may be concurrently severed by a cutting instrument at said first location.

9. The holding apparatus of claim 8 wherein a suture retainer is formed on each of said strut members, and wherein said first suture threads and said second suture threads are passed through said suture retainer in side-by-side juxtaposition, such that said first and second suture threads may be simultaneously cut by a single cutting action performed at the location of said suture retainer.

10. The holding apparatus of claim 9 wherein a cutting instrument receiving slot is formed in said holding apparatus, in the region of said suture retainer, to permit a cutting instrument to be inserted for the purpose of cutting said first and second suture threads at the location of said suture retainer.

11. The holding apparatus of claim 9 wherein said suture retainers are located adjacent the distal end of the holding apparatus so as to be easily accessible during the implantation procedure.

12. The holding apparatus of claim 1 wherein:

said at least one strut member comprises three strut members spaced substantially equidistant from one another.

13. The holding apparatus of claim 1 wherein:

said proximal ring member has a plurality of suture-passage apertures extending therethrough to facilitate suturing of said proximal ring member to the proximal end of a prosthesis disposed within said hollow prosthesis retention space.

14. The holding apparatus of claim 1 wherein a series of suture passage apertures are formed in said proximal ring member, on either side of each strut member, to permit a suture thread to be passed therethrough for the purpose of releasably attaching said proximal ring member to the inflow annulus of a heart valve prosthesis positioned within the prosthesis retention space of the holding apparatus.

15. The holding apparatus of claim 14 wherein 18-24 of said suture passage apertures are formed in said proximal ring member.

16. A heart valve prosthesis implantation system comprising the holding apparatus of claim 1, further in combination with a heart valve prosthesis disposed within the prosthesis retention space of said holding apparatus.

17. The system of claim 16 wherein said heart valve prosthesis is a stentless porcine bioprosthesis.

18. The system of claim 16 wherein said plurality of valving members disposed within the cylindrical prosthesis body comprise tricuspid valve leaflets.

19. The system of claim 18 wherein said heart valve prosthesis further comprises:

markers formed on said cylindrical prosthesis body, distal to said valve leaflets, to guide the optional cutting of the prosthesis body to remove a distal portion of the prosthesis body without injuring the valve leaflets.

20. A stentless aortic heart valve system incorporating the holding apparatus of claim 1, said system comprising:

a holding apparatus according to claim 1;

a stentless aortic bioprosthesis comprising a generally tubular prosthesis body having an inflow annulus at the proximal end thereof, an outflow annulus at the distal end thereof, a plurality of valving members disposed therewithin to hemodynamically valve blood passing through the tubular prosthesis body, and a mesh ring attached to the inflow annulus of the bioprosthesis;

said bioprosthesis being positioned within the prosthesis retention space of the holding apparatus, such that the mesh ring of the bioprosthesis protrudes beyond the proximal end of the holding apparatus.

21. The stentless aortic bioprosthesis system of claim 20 herein:

a proximal ring member is formed on the bottom ends of the elongate strut members of the holding apparatus, said proximal ring member having a plurality of suture passage apertures formed therein; and

,

at least one suture thread being passed in and out of the suture passage apertures formed in the proximal ring member of the holding apparatus and through the prosthesis body to effect releasable attachment of the proximal ring member of the holding apparatus to the prosthesis while the prosthesis is positioned within the retention space of the holding apparatus.

22. The stentless aortic bioprosthesis system of claim 21 wherein the proximal ring member of the holding apparatus is separable into a plurality of segments after it has been disconnected from the prosthesis.

23. The holding apparatus of claim 1 wherein the hub member positionable adjacent the distal end of the prosthesis body is configured so as not to block the entire outflow annulus of the bioprosthesis positioned within the holding apparatus, thereby allowing one to see the orientation of the valve leaflets by looking downwardly through the outflow annulus of the bioprosthesis.

24. The holding apparatus of claim 1 wherein said plurality of elongate strut members and said releasable attachments are attached about the bioprosthesis in such a manner as to rigidly hold the bioprosthesis in a fully open configuration, thereby deterring the formation of plications in the bioprosthesis during the implantation procedure.

25. A method for implanting a prosthetic heart valve having a generally cylindrical prosthesis body, an inflow aperture formed at a proximal end of the generally cylindrical prosthesis body, an outflow aperture formed at the distal end of the prosthesis body, a plurality of valving members disposed within the prosthesis body, and a longitudinal axis projectable longitudinally through the prosthesis body, said method comprising the steps of:

a) providing a holding apparatus which comprises a rigid holding apparatus body having a distal end, a proximal end and a hollow heart valve prosthesis retention space defined therewithin, and a releasable attachment member for releasably connecting a heart valve prosthesis mounted within the prosthesis retention space, to the holding apparatus;

b) positioning the heart valve prosthesis within the prosthesis retention space of the holding apparatus said heart valve prosthesis having a distal end and a proximal end, an outflow annulus being formed at the proximal end thereof;

c) utilizing the releasable attachment member to temporarily connect at least the proximal end of the holding apparatus to at least the proximal end of the prosthesis;

d) positioning the holding apparatus, with the heart valve prosthesis releasably mounted therewithin, a spaced distance away from an intended implantation site in the body of a patient with the proximal end of the prosthesis closest to the implantation site;

e) passing a plurality of suture threads through the intended implantation site in the body of the patient and through the inflow annulus of the heart valve prosthesis;

f) pushing the distal end of the body toward the implantation site, to advance the holding apparatus, with the heart valve prosthesis releasably mounted therein, over the previously placed suture threads, to a position where the inflow annulus of the heart valve prosthesis is in contact with the intended implantation site within the body of the patient;

g) causing the releasable connection member to release the heart valve prosthesis from its connection with the holding apparatus; and

h) extracting and removing the holding apparatus, leaving the heart valve prosthesis at the intended implantation site.

26. The method of claim 25 wherein said method further comprises:

i) tying and cutting the previously placed suture threads to secure the inflow annulus of the heart valve prosthesis to the intended implantation site of the patient.

27. The method of claim 26 wherein said method further comprises the step of:

suturing the outflow aperture at the distal end of the heart valve prosthesis to the body of the patient, at a location which is downstream of the site at which the inflow aperture of the prosthesis was sutured to the body of the patient.

28. The method of claim 27 wherein the bioprosthesis has right and left coronary openings formed therein at locations which correspond to the right and left coronary ostia of the patient, and wherein the method further comprises the step of:

j) suturing the coronary openings of the prosthesis to the aortic tissue of the patient such that coronary openings of the prosthesis are in alignment with the patient'"'"'s coronary ostia, thereby allowing a portion of the blood which passes out of the outflow annulus of the prosthesis to flow into the coronary arteries of the patient.

29. The method of claim 28 wherein the holding apparatus provided in step a of the method has a unitary proximal ring member which is attached to the proximal portion of the prosthesis while the prosthesis is positioned within the retention space of the holding apparatus, and wherein step h of the method is performed before step j of the method.

30. The method of claim 28 wherein the holding apparatus provided in step a has a segmented ring member which is attached by releasable connection to a proximal portion of the bioprosthesis while the bioprosthesis is positioned within the retention space of the holding apparatus, said ring member being subsequently separable into a plurality of segments such that gaps exist between said ring member segments, and wherein:

step j of the method is performed prior to step h of the method, and step h is modified to include separation of the segments of the proximal ring member, and extraction of the holding apparatus such that the sutured connection between the coronary openings of the prosthesis and the aortic tissue of the patient will remain intact and will pass through the gaps which have been created between the segments of the proximal ring member.

31. A holding apparatus for facilitating the surgical implantation of a heart valve prosthesis of the type having, i) a generally tubular prosthesis body having an inner surface, an outer surface, a proximal end, a distal end, an inflow annulus at the proximal end thereof, an outflow annulus at the distal end thereof, and ii) a plurality of valving members disposed within the prosthesis body to perform an hemodynamic valving function and a sewing ring attached to the inflow annulus to facilitate suturing of the inflow annulus to an endogenous opening, said holding apparatus comprising:

a) a hub member positionable adjacent the distal end of the prosthesis body;

b) a plurality of elongate strut members having proximal ends and distal ends which are attached to said hub member such that the strut members extend substantially downward therefrom so as to define a hollow prosthesis retention space inboard of said strut members and beneath said hub member;

c) an attachment ring disposed on the proximal ends of the strut members for maintaining the prosthesis within said prosthesis retention space, the proximal inflow end of the prosthesis being releasably connected to the attachment ring to allow the holding apparatus to be selectively disengaged from the prosthesis, said attachment ring further comprising;

an inner ring member attached to the proximal ends of the strut members; and

an outer ring member releasably attached to the inner ring member, a portion of said prosthesis being frictionally captured between the inner and outer ring members;

wherein the application of a force in a distal direction to the hub member subsequent to the detachment of the outer ring member from the inner ring member facilitates the distal movement of the inner ring member relative to the outer ring member thereby resulting in the separation of the inner and outer ring members from each other and the release of the portion of the prosthesis from therebetween.

32. The holding apparatus of claim 31, further comprising:

an elongate handle attachable to the hub member of the holding apparatus, and extendable in a distal direction therefrom.

33. The holding apparatus of claim 32 wherein said hub member has a female retention bore formed therein and wherein said elongate handle member has a distal male member formed thereon, the distal male member of said handle being engageable within the female retention bore of the hub member to effect attachment of said handle to said holding apparatus.

34. The holding apparatus of claim 31 wherein said inner and outer ring members are releasably attached to each other by at least one suture thread extending therebetween.

35. The holding apparatus of claim 34 wherein said inner and outer ring members each include at least one pair of suture passage apertures formed therein, the suture passage apertures of one pair being coaxially aligned with respective ones of the suture passage apertures of the other pair for permitting the suture thread to be extended between the inner and outer ring members.

36. The holding apparatus of claim 35 wherein said inner and outer ring members each include at least one enlarged attachment region formed thereon, each pair of the suture passage apertures being formed within a respective attachment region.

37. The holding apparatus of claim 36 wherein the attachment region formed on the inner ring member includes a cutting instrument receiving notch formed therein which is sized and configured to permit a cutting instrument to be inserted thereinto for purposes of cutting the suture thread.

38. The holding apparatus of claim 31 wherein:

said inner ring member defines a beveled outer surface portion; and

said outer ring member defines a beveled inner surface portion having a configuration which is complementary to the outer surface portion of the inner ring member;

the portion of the prosthesis being frictionally captured between the outer and inner surface portions when the inner and outer ring members are releasably attached to each other.

39. The holding apparatus of claim 31 wherein said outer ring member includes at least one tab portion extending distally therefrom which is sized and configured to engage the inner ring member subsequent to the distal movement of the inner ring member relative to the outer ring member in an amount sufficient to release the portion of the prosthesis from therebetween.

40. The holding apparatus of claim 39 wherein:

said at least one strut member comprises three strut members spaced substantially equidistantly from one another.

41. The holding apparatus of claim 40 wherein said outer ring member includes three (3) pairs of tab portions extending distally therefrom, the tab portions of each pair being disposed on either side of a respective one of the strut members when the inner and outer ring members are attached to each other.

42. A heart valve prosthesis implantation system comprising the holding apparatus of claim 31, further in combination with a heart valve prosthesis disposed within the prosthesis retention space of said holding apparatus.

43. The system of claim 42 wherein said heart valve prosthesis is a stentless porcine bioprosthesis.

44. The system of claim 42 wherein said plurality of valving members disposed within the cylindrical prosthesis body comprise tricuspid valve leaflets.

45. The system of claim 44 wherein said heart valve prosthesis further comprises:

markers formed on said cylindrical prosthesis body, distal to said valve leaflets, to guide the optional cutting of the prosthesis body to remove a distal portion of the prosthesis body without injuring the valve leaflets.

46. A stentless aortic heart valve system incorporating the holding apparatus of claim 31, said system comprising:

a holding apparatus according to claim 31;

a stentless aortic bioprosthesis comprising a generally tubular prosthesis body having an inflow annulus at the proximal end thereof, an outflow annulus at the distal end thereof, a plurality of valving members disposed therewithin to hemodynamically valve blood passing through the tubular prosthesis body, and a mesh ring attached to the inflow annulus of the bioprosthesis;

said bioprosthesis being positioned within the prosthesis retention space of the holding apparatus, such that the mesh ring of the bioprosthesis protrudes beyond the proximal end of the holding apparatus.

47. The holding apparatus of claim 31 wherein the hub member positionable adjacent the distal end of the prosthesis body is configured so as not to block the entire outflow annulus of the bioprosthesis positioned within the holding apparatus, thereby allowing one to see the orientation of the valve leaflets by looking downwardly through the outflow annulus of the bioprosthesis.

48. The holding apparatus of claim 31 wherein said attachment ring is attached to the bioprosthesis in such a manner as to rigidly hold the bioprosthesis in a fully open configuration, thereby deterring the formation of plications in the bioprosthesis during the implantation procedure.

49. A method for implanting a prosthetic heart valve having a generally cylindrical prosthesis body, an inflow aperture formed at a proximal end of the generally cylindrical prosthesis body, an outflow aperture formed at the distal end of the prosthesis body, a plurality of valving members disposed within the prosthesis body, and a longitudinal axis projectable longitudinally through the prosthesis body, said method comprising the steps of:

a) providing a holding apparatus which comprises a rigid body having a distal end, a proximal end and a hollow heart valve prosthesis retention space defined therewithin, and an attachment ring disposed on the proximal end of the body for releasably connecting a heart valve prosthesis mounted within the prosthesis retention space to the holding apparatus.

b) positioning the heart valve prosthesis within the prosthesis retention space of the holding apparatus, said heart valve prosthesis having a distal end and a proximal end, an outflow annulus being formed at the proximal end thereof;

c) utilizing the attachment ring to temporarily connect at least the proximal end of the body to at least the proximal end of the prosthesis;

d) positioning the holding apparatus, with the heart valve prosthesis releasably mounted therewithin, a spaced distance away from an intended implantation site in the body of a patient with the proximal end of the prosthesis closest to the implantation site;

e) passing a plurality of suture threads through the intended implantation site in the body of the patient and through the inflow annulus of the heart valve prosthesis;

f) pushing the distal end of the body toward the implantation site, to advance the holding apparatus, with the heart valve prosthesis releasably mounted therein, over the previously placed suture threads, to a position where the inflow annulus of the heart valve prosthesis is in contact with the intended implantation site within the body of the patient;

g) causing the attachment ring to release the heart valve prosthesis from its connection with the holding apparatus; and

h) extracting and removing the holding apparatus, leaving the heart valve prosthesis at the intended implantation site.

50. The method of claim 49 wherein said method further comprises:

i) tying and cutting the previously placed suture threads to secure the inflow annulus of the heart valve prosthesis to the intended implantation site of the patient.

51. The method of claim 50 wherein said method further comprises the step of:

suturing the outflow aperture at the distal end of the heart valve prosthesis to the body of the patient, at a location which is downstream of the site at which the inflow aperture of the prosthesis was sutured to the body of the patient.

52. The method of claim 51 wherein the bioprosthesis has right and left coronary openings formed therein at locations which correspond to the right and left coronary ostia of the patient, and wherein the method further comprises the step of:

j) suturing the coronary openings of the prosthesis to the aortic tissue of the patient such that the coronary openings of the prosthesis are in alignment with the patient'"'"'s coronary ostia, thereby allowing a portion of the blood which passes out of the outflow annulus of the prosthesis to flow into the coronary arteries of the patient.

53. A holding apparatus for facilitating the surgical implantation of a heart valve prosthesis of the type having, i) a generally tubular prosthesis body having an inner surface, an outer surface, a proximal end, a distal end, an inflow annulus at the proximal end thereof, an outflow annulus at the distal end thereof, and ii) a plurality of valving members disposed within the prosthesis body to perform a hemodynamic valving function and a sewing ring attached to the inflow annulus to facilitate suturing of the inflow annulus to an endogenous opening, said holding apparatus comprising:

a) a hub member positionable adjacent the distal end of the prosthesis body

b) a plurality of elongate strut members having proximal ends and distal ends which are attached to said distal hub member such that the strut members extend substantially downward therefrom so as to define a hollow prosthesis retention space inboard of said strut members and beneath said hub member;

c) at least one releasable attachment means for releasably holding the prosthesis within said prosthesis retention space such that the proximal inflow end of the prosthesis is connected to the strut members;

d) a plurality of first suture threads anchored to the proximal ends of the strut members of the holding apparatus, the first suture threads being passed through the inflow annulus at the proximal end of a heart valve prosthesis disposed within the hollow prosthesis retention space of the holding apparatus to connect the proximal ends of the strut members to the inflow annulus of the prosthesis; and

,

e) a plurality of second suture threads anchored to the distal hub member of the holding apparatus, the second suture threads being passed through the heart valve prosthesis at locations which are distal to the proximal end of the prosthesis to effect further connection of the prosthesis to the holding apparatus, wherein,

a portion of each of said first and second suture threads being passed through and positioned in side-by-side juxtaposition at first locations on the holding apparatus which are sufficiently accessible during the implantation procedure to permit concurrently severing by a cutting instrument of said first and second suture threads at said first locations, thereby causing the prosthesis to be disconnected from the holding apparatus such that the holding apparatus may be subsequently extracted and removed, leaving the heart valve prosthesis in place.

54. The holding apparatus of claim 53 wherein a suture retainer is formed on each of said strut members, and wherein said first suture threads and said second suture threads are passed through said suture retainer in side-by-side juxtaposition, such that said first and second suture threads may be simultaneously cut by a single cutting action performed at the location of said suture retainer.

55. The holding apparatus of claim 54 wherein a cutting instrument receiving slot is formed in said holding apparatus, in the region of said suture retainer, to permit a cutting instrument to be inserted for the purpose of cutting said first and second suture threads at the location of said suture retainer.

56. A holding apparatus for facilitating the surgical implantation of a heart valve prosthesis of the type having, i) a generally tubular prosthesis body having an inner surface, an outer surface, a proximal end, a distal end, an inflow annulus at the proximal end thereof, an outflow annulus at the distal end thereof, and ii) a plurality of valving members disposed within the prosthesis body to perform a hemodynamic valving function and a sewing ring attached to the inflow annulus to facilitate suturing of the inflow annulus to an endogenous opening, said holding apparatus comprising:

a) a hub member positionable adjacent the distal end of the prosthesis body and configured so as not to block the entire outflow annulus of the bioprosthesis positioned within the holding apparatus, thereby allowing one to see the orientation of the valve leaflets by looking downwardly through the outflow annulus of the bioprosthesis;

b) a plurality of elongate strut members having proximal ends and distal ends which are attached to said distal hub member such that the strut members extend substantially downward therefrom so as to define a hollow prosthesis retention space inboard of said strut members and beneath said hub member; and

c) at least one releasable attachment means for releasably holding the prosthesis within said prosthesis retention space such that the proximal inflow end of the prosthesis is connected to the strut members.

57. The holding apparatus of claim 56, further comprising:

an elongate handle attachable to the distal hub member of the holding apparatus, and extendible in a distal direction therefrom.

58. The holding apparatus of claim 57 wherein said distal hub member has a female retention bore formed therein and wherein said elongate handle member has a distal male member formed thereon, the distal male member of said handle being engageable within the female retention bore of the distal hub member to effect attachment of said handle to said holding apparatus.

59. The holding apparatus of claim 56 further comprising:

at least one releasable attachment member for temporarily connecting the inflow annulus at the proximal end of a heart valve prosthesis disposed within said hollow prosthesis retention space, to the proximal ends of the strut members;

said releasable attachment member being manually disconnectable from said prosthesis in a manner which releases the holding apparatus from said prosthesis.

60. The holding apparatus of claim 59 wherein:

said at least one releasable attachment member comprises a suture thread anchored to the holding apparatus and passable through a prosthesis which is disposed within the hollow prosthesis retention space, to releasably attach said prosthesis to said holding apparatus;

a portion of said suture thread being located upon the holding apparatus at a first location which is sufficiently accessible during the implantation procedure to permit cutting of said suture thread at said first location, thereby causing the prosthesis to be disconnected from the holding apparatus such that the holding apparatus may be subsequently extracted and removed, leaving the heart valve prosthesis in place.

61. The holding apparatus of claim 60 wherein said holding apparatus further comprises:

a cutting instrument retention notch formed in said holding apparatus at said first location;

said cutting instrument retention notch being sized to permit a cutting instrument to be inserted thereinto for the purpose of cutting of said suture thread at said first location.

62. The holding apparatus of claim 56 wherein:

said at least one strut member comprises three strut members spaced substantially equidistant from one another.

63. A heart valve prosthesis implantation system comprising the holding apparatus of claim 56, further in combination with a heart valve prosthesis disposed within the prosthesis retention space of said holding apparatus.

64. The system of claim 63 wherein said heart valve prosthesis is a stentless porcine bioprosthesis.

65. A stentless aortic heart valve system incorporating the holding apparatus of claim 56, said system comprising:

a holding apparatus according to claim 56;

a stentless aortic bioprosthesis comprising a generally tubular prosthesis body having an inflow annulus at the proximal end thereof, an outflow annulus at the distal end thereof, a plurality of valving members disposed therewithin to hemodynamically valve blood passing through the tubular prosthesis body, and a mesh ring attached to the inflow annulus of the bioprosthesis;

said bioprosthesis being positioned within the prosthesis retention space of the holding apparatus, such that the mesh ring of the bioprosthesis protrudes beyond the proximal end of the holding apparatus.

66. The stentless aortic bioprosthesis system of claim 65 wherein:

a proximal ring member is formed on the bottom ends of the elongate strut members of the holding apparatus, said proximal ring member having a plurality of suture passage apertures formed therein; and

,

at least one suture thread being passed in and out of the suture passage apertures formed in the proximal ring member of the holding apparatus and through the prosthesis body to effect releasable attachment of the proximal ring member of the holding apparatus to the prosthesis while the prosthesis is positioned within the retention space of the holding apparatus.

67. The stentless aortic bioprosthesis system of claim 66 wherein the proximal ring member of the holding apparatus is separable into a plurality of segments after it has been disconnected from the prosthesis.

68. A holding apparatus for facilitating the surgical implantation of a heart valve prosthesis of the type having, i) a generally tubular prosthesis body having an inner surface, an outer surface, a proximal end, a distal end, an inflow annulus at the proximal end thereof, an outflow annulus at the distal end thereof, and ii) a plurality of valving members disposed within the prosthesis body to perform a hemodynamic valving function and a sewing ring attached to the inflow annulus to facilitate suturing of the inflow annulus to an endogenous opening, said holding apparatus comprising:

a) a hub member positionable adjacent the distal end of the prosthesis body

b) a plurality of elongate strut members having proximal ends and distal ends which are attached to said distal hub member such that the strut members extend substantially downward therefrom so as to define a hollow prosthesis retention space inboard of said strut members and beneath said hub member; and

c) at least one releasable attachment means for releasably holding the prosthesis within said prosthesis retention space such that the proximal inflow end of the prosthesis is connected to the strut members, wherein,

said plurality of elongate strut members and said releasable attachments are attached about the bioprosthesis in such a manner as to rigidly hold the bioprosthesis in a fully open configuration, thereby deterring the formation of plications in the bioprosthesis during the implantation procedure.

69. The holding apparatus of claim 68, further comprising:

an elongate handle attachable to the distal hub member of the holding apparatus, and extendible in a distal direction therefrom.

70. The holding apparatus of claim 69 wherein said distal hub member has a female retention bore formed therein and wherein said elongate handle member has a distal male member formed thereon, the distal male member of said handle being engageable within the female retention bore of the distal hub member to effect attachment of said handle to said holding apparatus.

71. The holding apparatus of claim 68 further comprising:

at least one releasable attachment member for temporarily connecting the inflow annulus at the proximal end of a heart valve prosthesis disposed within said hollow prosthesis retention space, to the proximal ends of the strut members;

said releasable attachment member being manually disconnectable from said prosthesis in a manner which releases the holding apparatus from said prosthesis.

72. The holding apparatus of claim 71 wherein:

said at least one releasable attachment member comprises a suture thread anchored to the holding apparatus and passable through a prosthesis which is disposed within the hollow prosthesis retention space, to releasably attach said prosthesis to said holding apparatus;

a portion of said suture thread being located upon the holding apparatus at a first location which is sufficiently accessible during the implantation procedure to permit cutting of said suture thread at said first location, thereby causing the prosthesis to be disconnected from the holding apparatus such that the holding apparatus may be subsequently extracted and removed, leaving the heart valve prosthesis in place.

73. The holding apparatus of claim 72 wherein said holding apparatus further comprises:

a cutting instrument retention notch formed in said holding apparatus at said first location;

said cutting instrument retention notch being sized to permit a cutting instrument to be inserted thereinto for the purpose of cutting of said suture thread at said first location.

74. The holding apparatus of claim 68 wherein:

said at least one strut member comprises three strut members spaced substantially equidistant from one another.

75. A heart valve prosthesis implantation system comprising the holding apparatus of claim 68, further in combination with a heart valve prosthesis disposed within the prosthesis retention space of said holding apparatus.

76. The system of claim 75 wherein said heart valve prosthesis is a stentless porcine bioprosthesis.

77. A stentless aortic heart valve system incorporating the holding apparatus of claim 68, said system comprising:

a holding apparatus according to claim 68;

a stentless aortic bioprosthesis comprising a generally tubular prosthesis body having an inflow annulus at the proximal end thereof, an outflow annulus at the distal end thereof, a plurality of valving members disposed therewithin to hemodynamically valve blood passing through the tubular prosthesis body, and a mesh ring attached to the inflow annulus of the bioprosthesis;

said bioprosthesis being positioned within the prosthesis retention space of the holding apparatus, such that the mesh ring of the bioprosthesis protrudes beyond the proximal end of the holding apparatus.

78. The stentless aortic bioprosthesis system of claim 77 wherein:

a proximal ring member is formed on the bottom ends of the elongate strut members of the holding apparatus, said proximal ring member having a plurality of suture passage apertures formed therein; and

,

at least one suture thread being passed in and out of the suture passage apertures formed in the proximal ring member of the holding apparatus and through the prosthesis body to effect releasable attachment of the proximal ring member of the holding apparatus to the prosthesis while the prosthesis is positioned within the retention space of the holding apparatus.

79. The stentless aortic bioprosthesis system of claim 78 wherein the proximal ring member of the holding apparatus is separable into a plurality of segments after it has been disconnected from the prosthesis.

80. A stentless aortic heart valve system incorporating a holding apparatus for facilitating the surgical implantation of a stentless heart valve prosthesis of the type having, i) a generally tubular prosthesis body having an inner surface, an outer surface, a proximal end, a distal end, an inflow annulus at the proximal end thereof, an outflow annulus at the distal end thereof, and ii) a plurality of valving members disposed within the prosthesis body to perform an hemodynamic valving function and a sewing ring attached to the inflow annulus to facilitate suturing of the inflow annulus to an endogenous opening, said system comprising:

a) a hub member positionable adjacent the distal end of the prosthesis body;

b) a plurality of elongate strut members having proximal ends and distal ends which are attached to said hub member such that the strut members extend substantially downward therefrom so as to define a hollow prosthesis retention space inboard of said strut members and beneath said hub member; and

c) an attachment ring disposed on the proximal ends of the strut members for maintaining the prosthesis within said prosthesis retention space, the proximal inflow end of the prosthesis being releasably connected to the attachment ring to allow the holding apparatus to be selectively disengaged from the prosthesis,

said stentless aortic bioprosthesis having a mesh ring attached to the inflow annulus of the bioprosthesis and being positioned within the prosthesis retention space of the holding apparatus, such that the mesh ring of the bioprosthesis protrudes beyond the proximal end of the holding apparatus.

81. A holding apparatus for facilitating the surgical implantation of a heart valve prosthesis of the type having, i) a generally tubular prosthesis body having an inner surface, an outer surface, a proximal end, a distal end, an inflow annulus at the proximal end thereof, an outflow annulus at the distal end thereof, and ii) a plurality of valving members disposed within the prosthesis body to perform an hemodynamic valving function and a sewing ring attached to the inflow annulus to facilitate suturing of the inflow annulus to an endogenous opening, said holding apparatus comprising:

a) a hub member positionable adjacent the distal end of the prosthesis body and configured so as not to block the entire outflow annulus of the bioprosthesis positioned within the holding apparatus, thereby allowing one to see the orientation of the valve leaflets by looking downwardly through the outflow annulus of the bioprosthesis;

b) a plurality of elongate strut members having proximal ends and distal ends which are attached to said hub member such that the strut members extend substantially downward therefrom so as to define a hollow prosthesis retention space inboard of said strut members and beneath said hub member; and

c) an attachment ring disposed on the proximal ends of the strut members for maintaining the prosthesis within said prosthesis retention space, the proximal inflow end of the prosthesis being releasably connected to the attachment ring to allow the holding apparatus to be selectively disengaged from the prosthesis.

82. A holding apparatus for facilitating the surgical implantation of a heart valve prosthesis of the type having, i) a generally tubular prosthesis body having an inner surface, an outer surface, a proximal end, a distal end, an inflow annulus at the proximal end thereof, an outflow annulus at the distal end thereof, and ii) a plurality of valving members disposed within the prosthesis body to perform an hemodynamic valving function and a sewing ring attached to the inflow annulus to facilitate suturing of the inflow annulus to an endogenous opening, said holding apparatus comprising:

a) a hub member positionable adjacent the distal end of the prosthesis body;

b) a plurality of elongate strut members having proximal ends and distal ends which are attached to said hub member such that the strut members extend substantially downward therefrom so as to define a hollow prosthesis retention space inboard of said strut members and beneath said hub member; and

c) an attachment ring disposed on the proximal ends of the strut members for maintaining the prosthesis within said prosthesis retention space, the proximal inflow end of the prosthesis being releasably connected to the attachment ring to allow the holding apparatus to be selectively disengaged from the prosthesis, wherein,

said attachment ring is attached to the bioprosthesis in such a manner as to rigidly hold the bioprosthesis in a fully open configuration, thereby deterring the formation of plications in the bioprosthesis during the implantation procedure.