U.S. patent application number 12/139990 was filed with the patent office on 2008-10-09 for valve holder.
This patent application is currently assigned to 3F Therapeutics, Inc.. Invention is credited to Demetrio Bicer.
Application Number | 20080249620 12/139990 |
Document ID | / |
Family ID | 35061610 |
Filed Date | 2008-10-09 |
United States Patent
Application |
20080249620 |
Kind Code |
A1 |
Bicer; Demetrio |
October 9, 2008 |
VALVE HOLDER
Abstract
A valve holder assembly having a main valve holder and a
detachable secondary valve holder for positioning a heart valve
prosthesis and a method of implanting a stentless heart valve
prosthesis are disclosed.
Inventors: |
Bicer; Demetrio; (Trabuco
Canyon, CA) |
Correspondence
Address: |
OPPENHEIMER WOLFF & DONNELLY LLP
45 SOUTH SEVENTH STREET, SUITE 3300
MINNEAPOLIS
MN
55402
US
|
Assignee: |
3F Therapeutics, Inc.
Lake Forest
CA
|
Family ID: |
35061610 |
Appl. No.: |
12/139990 |
Filed: |
June 16, 2008 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
11102345 |
Apr 8, 2005 |
7410499 |
|
|
12139990 |
|
|
|
|
60561746 |
Apr 13, 2004 |
|
|
|
Current U.S.
Class: |
623/2.11 ;
606/139 |
Current CPC
Class: |
A61F 2/2412 20130101;
A61F 2/2427 20130101 |
Class at
Publication: |
623/2.11 ;
606/139 |
International
Class: |
A61F 2/24 20060101
A61F002/24; A61B 17/12 20060101 A61B017/12 |
Claims
1. A method of implantation of a stentless heart valve prosthesis
comprising: positioning a stentless heart valve prosthesis within a
secondary heart valve holder, that is nested within a main valve
holder; suturing a suture ring of the stentless heart valve
prosthesis to an aortic annulus; removing the main valve holder;
collapsing the secondary valve holder and stentless heart valve
prosthesis and tying the sutures securing the suture ring of the
stentless heart valve prosthesis to the aortic annulus; extending
the secondary valve holder and stentless heart valve prosthesis to
an uncollapsed position; suturing the stentless heart valve
prosthesis to the aortic wall; and removing the secondary valve
holder.
2. The method claimed in claim 1, further comprising suturing the
stentless heart valve prosthesis to the aortic wall at three
commissural posts.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of Ser. No. 11/102,345
filed Apr. 8, 2005 which claims the benefit of Provisional
Application Ser. No. 60/561,746 filed Apr. 13, 2004, the entireties
of which is hereby incorporated by reference.
FIELD OF THE INVENTION
[0002] This invention relates to devices and surgical procedures
utilized for holding a stentless heart valve prosthesis during
implantation.
DISCUSSION OF THE PRIOR ART
[0003] Heart valve replacement is required when a patient's heart
valve becomes diseased or damaged. Surgically-implanted hearted
valve prostheses have extended the life expectancy of many patients
who had defective natural valves. Such prostheses can be either
mechanical or biological (mitral or aortic). The aortic prosthesis
is implanted in the patient during a surgical procedure in which a
segment of the aorta nearby the natural valve is slit open so that
the malfunctioning valve can be removed and replaced with the
prosthetic valve. The prosthetic valve must be held in place while
the surgeon sutures or attaches the prosthetic heart valve to the
annulus of the heart. Holding the implant in place while the
surgeon places the sutures to attach it to the interior of the
patient's aorta presents a difficult problem, due to the limited
amount of space in the heart it is difficult to properly position
and suturing the valve at the site of the annulus. To aid the
surgeon during the implant procedure, it is known to use both
disposable and non-disposable holders to position the valve during
surgery. However, the known valve holders are large and cumbersome.
These known valve holders are also unwieldy and obstruct the
surgeon's view.
[0004] During this surgical procedure, the heart is typically
stopped, and the patient put on heart/lung bypass. The longer a
patient is required to rely on the artificial heart/lung bypass to
maintain vital functions, the greater the stress on the patient.
Thus there is a need to simplify the suturing of the heart valve
prosthesis to the aorta in order to minimize both the length of
surgery and the amount of time spent on heart/lung bypass.
[0005] Bioprosthesis from animal donors, such as those made of
equine tissue, are flexible and are often supported by mechanical
stents. A typical stented heart valve is disclosed in Duran, Reed
Valve for Implantation into Mammalian Blood Vessels and Heart with
Optional Temporary or Permanent Support, US 2005/0055079 A1.
However, such stents occupy space within the aorta of the patients
and may produce undesirable turbulence. Thus, there is a need to
improve the suturing of a stentless heart valve prosthesis.
Further, the positioning and alignment of the valve prosthesis to
closely match that of the natural valve requires precision
suturing.
[0006] The lack of a stent and easily pliable tissue material makes
implantation of stentless valve difficult and time consuming. The
stentless valves are very pliable and suturing and adequate
positioning of the valve is very difficult. Several assistants are
usually needed to holder the stentless valve in position with
fingers, forceps or hemostats. This procedure is awkward for both
the assistants and the surgeon performing the suturing. It is
clearly advantageous to perform the valve surgery quickly as
possible and to ensure symmetrical suturing and accurate placement
of the prosthesis.
SUMMARY OF THE INVENTION
[0007] The invention relates to an improved valve holder assembly
to position and hold a stentless valve prosthesis. A suitable
stentless heart valve prosthesis is that of Myers et al.,
Prosthetic Heart Valve, U.S. Pat. No. 6,682,559, hereby
incorporated by reference. The valve holder assembly has a main
valve holder that is open and generally cylindrical. This main
valve holder has a top member, adapted to receive a handle, a
generally cylindrical main valve holder ring base, and support
members connecting the top and base. The valve holder assembly
further includes a removable secondary valve holder that includes
three collapsible commissural posts radiating outwardly. The
secondary valve holder is adapted to nest within the hollow space
of the main valve holder and has substantially the same centerline
as the main valve holder. The secondary valve holder has a top
member allowing for removably connecting the secondary valve holder
to the main valve holder. The invention includes a rigid, hollow,
generally cylindrical and open main valve holder having a top
member adapted to receive a main valve holder handle, a generally
cylindrical main valve holder ring base, and support members
connecting the main valve holder top member and the ring base, the
main valve holder adapted to hold a prosthetic valve. A removable
secondary valve holder nests within the hollow space of the
generally cylindrical main valve holder and has substantially the
same centerline as the main valve holder. The secondary valve
holder includes a flat, disc-shaped secondary valve holder top
member removably connected to the main valve holder top member; a
rotational axel coupled to said secondary valve holder top member;
and three elongated commissural posts extending radially from said
top member and rotational axel along a substantially horizontal
axis thereof. The commissural posts are structured to collapse from
a position along the horizontal axis to a position along a
substantially vertical axis. The commissural posts are adapted to
position the prosthetic valve during surgical implantation.
[0008] The invention provides a valve holder assembly that is
securely attached to a prosthetic valve and allows the surgeon or
surgeon assistants to easily manipulate the valve holder assembly
so that the inflow portion of the suture ring of the replacement
valve is properly aligned with the aortic annulus and to ensure
symmetrical suturing and accurate placement of the prosthesis
commissural post tabs to the aortic wall. First, the surgeon
loosely sutures the suture ring of the replacement valve to the
aortic annulus and then can lower the valve with the holder into
the aortic wall to the aortic annulus. Next, the main valve holder
is then detached from the prosthetic valve by easily pulling away
cutting the temporary assembling sutures from the attached
prosthetic heart valve, leaving the secondary holder in place
attached to the valve from the three prosthesis commissural suture
tabs. Next, the retractable holder is collapsed. As a result, the
suture ring of the prosthetic heart valve is sutured into the
aortic annulus and remains unobstructed to the surgeons to tie the
sutures. Next, the retractable secondary holder is pulled up in a
straight line and the valve is aligned with the suture tabs in
symmetrical suturing placement. The commissural tabs are released
by cutting the assembling sutures from the secondary holder one by
one and sewn to the aortic wall. Finally, the secondary retractable
holder is released and removed from surgical field. An alternative
to the last step is to do the first suture to the top of each of
the suture tabs, release the secondary holder and then finish the
suturing as necessary.
[0009] With the utilization of the above mentioned instrument,
surgical procedures involving the implant of stentless heart valves
are less complicated and can be performed faster.
DESCRIPTION OF THE DRAWINGS
[0010] FIG. 1 is a top view of the valve holder assembly.
[0011] FIG. 2 is a side view of the valve holder assembly.
[0012] FIG. 3 is a top view of the secondary valve holder with a
heart valve prosthesis mounted therewithin.
[0013] FIG. 4 is a slide view of the valve, already sutured to the
aortic annulus and partially collapsed secondary valve holder.
[0014] FIG. 5 is a side view of the fully extended secondary valve
holder and stentless heart valve prosthesis along the aortic
wall.
[0015] FIG. 6 is a side view of a stentless heart valve prosthesis
sutured to the aortic annulus, the commissural post tabs sutured to
the aortic wall and the secondary valve holder removed.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0016] As shown in FIG. 1 and FIG. 2, the present invention is
directed to a valve holder assembly 1, having a main valve holder 3
and a retractable or removable secondary valve holder 5 within
which is positioned a stentless heart valve prosthesis 7. The main
valve holder 3 is generally cylindrical and open or hollow with a
main valve holder top member 9, adapted at hole 11, preferably
threaded, to receive a handle 13 as shown in FIG. 2. The main valve
holder 3 has narrow strut support members 19. Preferably, the main
valve holder base 17 is scalloped as the valve of U.S. Pat. No.
6,682,559 is scalloped. The stentless prosthetic heart valve 7
includes a prosthetic heart valve suture ring 21 to which main
valve holder assembly sutures 23 may be used to secure the
prosthetic heart valve suture ring 21 to the main valve holder 3.
Further, secondary holder valve assembling sutures 25 may be
employed to secure the main valve holder 3 to the secondary valve
holder 5.
[0017] The heart valve prosthesis 7 includes commissural valve tabs
27 secured to the secondary heart valve holder 5. As shown in FIG.
1 and FIG. 2, the main valve holder 3 and the secondary valve
holder 5 have substantially the same centerline 29. And the
secondary valve holder 5 is adapted to removably nest within the
main valve holder 3. As shown generally in FIGS. 1, 2 and 3 the
heart valve prosthesis 7 includes a rigid, hollow, generally
cylindrical and open main valve holder 3 having a top member 9
adapted to receive a main valve holder handle 13, a generally
cylindrical main valve holder ring base 17, and support members
connecting the main valve holder top member and the ring base 19.
The main valve holder 3 is adapted to hold a prosthetic valve 7. A
removable secondary valve holder 5 nests within the hollow space of
the generally cylindrical main valve holder 3 and has substantially
the same centerline as the main valve holder 3. The secondary valve
holder 5 includes a flat, disc-shaped secondary valve holder top
member 31 removably connected to the main valve holder top member
9; a rotational axel 15 coupled to said secondary valve holder top
member 31; and three elongated commissural posts 35 extending
radially from said top member 31 and rotational axel 15 along a
substantially horizontal axis thereof. The commissural posts 35 are
structured to collapse from a position along the horizontal axis to
a position along a substantially vertical axis.
[0018] Turning now to FIG. 3 and FIG. 4, the secondary valve holder
5 has a secondary valve top member 31 and three collapsible
commissural posts 35 preferably spaced 120 degree. from each other
and adapted to flex about rotational axle 15. In FIGS. 3 and 4, the
main valve holder 3 has been removed. FIG. 4 shows the secondary
valve holder 5 and the stentless heart valve prosthesis 7 in the
partially collapsed position.
[0019] FIG. 5 shows the secondary valve holder 5 in its extended or
non-collapsed position. The commissural post valve tabs 27 can be
sutured to the aortic wall 37 by means of sutures 39.
[0020] FIG. 6 shows the stentless heart valve prosthesis 7 sutured
to the aortic wall 37, with the secondary valve holder 5 removed,
and the suture ring sutured to the aortic annulus 41.
[0021] Having described the structure of the valve holder of this
invention, its method of use will now be discussed.
[0022] The valve holder assembly 1, including main valve holder 3,
secondary valve holder 5 and stentless heart valve prosthesis 7 is
employed for implantation as shown in FIG. 1 and FIG. 2 following
removal of a patient's diseased or damaged natural heart valve.
FIG. 4-FIG. 6 illustrates the implantation of the stentless heart
valve prosthesis 7 after suturing the valve suture ring 21 to the
aortic annulus 41, and removal of the main valve holder 3 by
cutting main valve holder assembling sutures 23. FIG. 4 illustrates
the secondary valve holder 5 and the stentless heart valve
prosthesis 7 in the partially collapsed position, allowing the
surgeon or technician to tie the suture of the stentless heart
valve prosthesis suturing 21 to the aortic annulus 41. Secondary
valve holder 5 may be collapsed by pressing secondary valve holder
handle 43.
[0023] FIG. 5 illustrates the secondary valve holder 5 in the
uncollapsed or fully extended implanting position, and one of the
three commissural valve tabs 27 removed from the secondary valve
holder 5 and sutured to the aortic wall 37. Finally, in FIG. 6, the
commissural valve tabs 27 have been sutured to the aortic wall 37,
and the secondary valve holder 5, that in effect acts as a
temporary stent during the implantation procedure only,
removed.
[0024] The holder of the present invention may be made of metal or
other plastic materials that can be cleaned or sterilized in an
autoclave, as it is well known by those skilled in the art. In
another embodiment, the holder is made of plastic and, thus be
disposable. Obviously, numerous variations and modifications can be
made within departing from the spirit of the present invention.
Therefore, it should be clearly understood that the forms of the
present invention described above and shown in the figures of the
accompanying drawings are illustrative only and are not intended to
limit the scope of the present invention.
* * * * *