U.S. patent number 3,828,787 [Application Number 05/287,420] was granted by the patent office on 1974-08-13 for collet for holding heart valve.
This patent grant is currently assigned to Medical Incorporated. Invention is credited to Lawrence Anderson, Bruce D. Bentzen.
United States Patent |
3,828,787 |
Anderson , et al. |
August 13, 1974 |
COLLET FOR HOLDING HEART VALVE
Abstract
A holder for a pivoting disc heart valve used to implant the
valve in a heart. The holder has an elongated handle carrying a
disposable collet. The collet has a body adapted to be releasably
connected to the end of the handle. One end of the body has an
enlarged head having a groove for accommodating a portion of the
valve disc to hold the disc in the open position. Integral with the
head is an elongated flexible band adapted to be positioned over
the side arms and disc of the valve to cover the side arms and
disc. A portion of the band is attached to the body to hold the
band in engagement with the side arms and disc.
Inventors: |
Anderson; Lawrence
(Minneapolis, MN), Bentzen; Bruce D. (Minneapolis, MN) |
Assignee: |
Medical Incorporated
(Minneapolis, MN)
|
Family
ID: |
23102824 |
Appl.
No.: |
05/287,420 |
Filed: |
September 8, 1972 |
Current U.S.
Class: |
606/1; 606/107;
623/2.24 |
Current CPC
Class: |
A61F
2/2427 (20130101) |
Current International
Class: |
A61F
2/24 (20060101); A61b 017/00 () |
Field of
Search: |
;128/303 ;3/1,DIG.3
;81/3 |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
"Heart Valve Replacement with the Lillehei-Kaster Pivoting Disc
Prosthesis," Presented Before 8th Biennial Cardiac Congress July
1972, Durban, South Africa..
|
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: Yasko; J.
Claims
The embodiments of the invention in which an exclusive property or
privilege is claimed are defined as follows:
1. A collet for holding a heart valve having a base, a passage
through the base, a disc positionable in the passage for movement
to open and closed positions, and arm means secured to the base
cooperating with the disc to retain the disc in assembled relation
with the base comprising: a body having a head, said head having an
annular portion engageable with one side of the base, a groove for
accommodating a portion of the disc to hold the disc in the open
position, an elongated flexible means secured to the head section,
said flexible means positionable over the arm means and disc, and
means to secure the flexible means to the body to hold the flexible
means in position over the arm means and disc.
2. The collet of claim 1 wherein: said body is an elongated
cylindrical member having means to attach the body to an elongated
handle.
3. The collet of claim 2 wherein: the head has an outwardly
directed annular section at one end of the body, said section
having an annular portion engageable with one side of the base when
the valve is mounted on the collet.
4. The collet of claim 1 wherein; the head has a passage for
accommodating a first portion of the flexible means, said body
having a transverse passage for receiving a second portion of the
flexible means, said means to secure the flexible means in the body
extended into the transverse passage and engageable with the second
portion of the flexible means to hold the flexible means in
position over the arm means and the disc.
5. The collet of claim 1 wherein: the elongated flexible means is
an elongated flexible sheet member having an enlarged section
positionable over the arms and disc and a ribbon section, said
means securing the flexible means to the body comprising means
engageable with the ribbon section.
6. The collet of claim 1 wherein: the elongated flexible means is a
sheet member having a connecting portion molded into the head.
7. The collet of claim 1 wherein: said body is a cylindrical member
having a longitudinal threaded passage open to a transverse
passage, said transverse passage adapted to receive a portion of
the flexible means, and said means to secure the flexible means
being located in the longitudinal passage for holding the flexible
means in the transverse passage.
8. The collet of claim 1 wherein: the body, the head and flexible
means are made of plastic material.
9. A collet for holding a heart valve having a base, a passage
through the base, valving means movable to open and closed
positions, and means secured to the base cooperating with the
valving means to retain the valving means in assembled relation
with the base comprising: a body having a portion engageable with
one side of the base, said portion having a means for accommodating
a portion of the valving means to hold the valving means in the
open position, elongated flexible means secured to the body and
adapted to cooperate with the heart valve to hold the base on the
body, said flexible means having an end section, and means
engageable with the end section to secure the end section to the
body.
10. The collet of claim 9 wherein: said body is an elongated
cylindrical member having means to attach the body to an elongated
handle.
11. The collet of claim 10 wherein: the portion of the body has an
outwardly directed annular section at one end of the body.
12. The collet of claim 9 wherein: the portion of the body has a
passage for accommodating a first portion of the flexible means,
said body having a transverse passage for receiving the end section
of the flexible means, said means engageable with the end section
extended into the transverse passage and engageable with the end
section.
13. The collet of claim 9 wherein; the elongated flexible means is
an elongated flexible sheet member having an enlarged section, said
end section being an elongated ribbon section attached to the
enlarged section.
14. The collet of claim 9 wherein: the elongated flexible means is
a flexible sheet member having a connecting portion molded into the
body.
15. The collet of claim 9 wherein; said body is a cylindrical
member having a longitudinal threaded passage open to a transverse
passage, said transverse passage adapted to receive a portion of
the end section of the flexible means, said means engageable with
the end section being located in the longitudinal passage.
16. The collet of claim 9 wherein: the body, and flexible means are
made of plastic material.
17. The collet of claim 9 wherein: the means for accommodating a
portion of the valving means includes a groove in the body for
receiving said portion of the valving means.
Description
BACKGROUND OF THE INVENTION
Holding structures are used with prosthetic heart valves during
surgical procedures to facilitate the implantation of valves in the
heart. These holders have elongated handles connected to collets.
The valve base is releasably retained on the collets until the
suturing member or skirt is attached to the heart tissue with
sutures. The collet is then released, permitting the valve to
function. The collet does not avoid the possibility of snagging a
stitch over a portion of the valve or forcing portions of the valve
into the heart tissue. Also, when the collet is removed from the
valve, there is a possibility that one or more parts of the holding
structure of the collet will be lost in the heart.
SUMMARY OF THE INVENTION
The invention is related to a holder for a heart valve which
facilitates the implantability of the valve. The holder has a
collet adapted to releasably accommodate a pivoting disc valve, as
shown in U.S. Pat. No. 3,476,143 and U.S. patent application Ser.
No. 124,754. The pivoting disc valve has an annular base carrying a
suturing member. The base has a passage accommodating a pivoting
disc which selectively moves to open and closed positions to allow
flow of blood through the passage and restrict the flow of blood
through the passage. Arm means secured to the base cooperate with
the disc to retain the disc in assembled free-floating relation
with the base. The collet has a body carrying a head. The head has
an annular portion engageable with one side of the valve base and a
groove for accommodating a portion of the disc to hold the disc in
the open position. An elongated flexible band is secured to the
head. The band is positionable over the arm means and the open disc
to cover and protect the outer ends of the arms and the disc. The
band also holds the valve in assembled relation with the collet. In
use, the band prevents the possibility of snagging a stitch over an
arm and forcing an arm into heart tissue, i.e., myocardium. The
band has an end portion attached to the body to hold the valve base
on the head and the band in protective engagement with the arms and
disc. A section of the end portion of the band is exposed so that
it can be cut after the valve has been implanted. The band can only
be cut in one place, thereby eliminating the possibility of having
band or collet structural pieces being lost in the wound.
IN THE DRAWINGS
FIG. 1 is a side elevational view of a heart valve mounted on a
valve holder equipped with the collet of the invention;
FIG. 2 is a plan view of the collet of the valve holder;
FIG. 3 is a side elevational view of FIG. 2;
FIG. 4 is an elevational view of the right end of FIG. 2;
FIG. 5 is an enlarged sectional view taken along the line 5--5 of
FIG. 2;
FIG. 6 is a fragmentary side view, partly sectioned, of the
collet;
FIG. 7 is a sectional view taken along line 7--7 of FIG. 1;
FIG. 8 is a top plan view of a heart valve mounted on the collet;
and
FIG. 9 is a sectional view taken along line 9--9 of FIG. 8.
Referring to the drawings, there is shown in FIg. 1 a pivoting disc
heart valve indicated generally at 10 carrying an annular suturing
member or collar 11. Valve 10 is mounted on a holder indicated
generally at 12. Holder 12 has a collet 13 connected to an
elongated handle 14. Holder 12 is used to position the valve in the
heart and hold the valve in position during open heart surgery.
Heart valve 10 is a pivoting disc valve as shown in U.S. Pat. No.
3,476,143 and U.S. Pat. No. 3,737,919. Referring to FIG. 9, valve
10 has an annular base 16 having a passage 17 permitting the flow
of blood through the base. Operatively located within passage 17 is
an occluder or disc 18. The disc 18 is operable to pivot between
open and closed positions. As shown in FIG. 9, the disc 18 is in
its open position. A pair of side arms or struts 19 and 21 project
upwardly from base 16 in the direction of the opening pivot
movement of the disc and cooperate with separate portions of the
outer peripheral edge of the disc 18 to retain the disc in free
floating pivotal relation with the base.
Returning to FIGS. 1 to 6, the collet 13 has a cylindrical body 22
of plastic material, as Teflon or Delrin. The upper end of the body
22 has an enlarged circular head 23. The top of the head has a flat
surface or face 24. Face 24 has a diameter equal to the diameter of
the proximal side of the base 16, as shown in FIG. 9. Face 24 has
an annular surface that engages the proximal side of the base 16.
An elongated flexible sheet member or band 26 is joined to the head
23 with connecting section 27. As shown in FIG. 5, connecting
section 27 is integral with the head 23. The band 26 is a flexible
plastic strap, as Teflon, made separately from the body 22. During
the molding of the plastic body 22, connecting section 27 is molded
into the head. Band 26 has a longitudinal ribbon or tail 28
extended longitudinally from an enlarged cover section 29. Section
29 has an elongated elliptical shape and has a width to cover the
ends of the arms 19 and 21 and the upper outer peripheral edge of
disc 18, as shown in FIG. 8.
As shown in FIGS. 5 and 6, the head 23 has a groove or
semi-circular recess 30 inwardly of and adjacent the connecting
section 27. The groove has an arcuate configuration corresponding
to the curvature of the outer peripheral edge of the disc 18 and a
slight inward incline. Groove 30 accommodates a peripheral portion
of the disc, as shown in broken lines in FIG. 6, to hold the disc
in an inclined open position when the valve is mounted on the
collet 13. Located opposite groove 30 is an opening or passage 31.
Passage 31 extends from surface 24 downwardly through the head 23.
The upper portion of body 22 has a transverse passage 32. One end
of passage 32 is longitudinally aligned with the exit opening of
passage 31. Body 22 has a longitudinal threaded passage 33 open to
the transverse passage 32. As shown in FIGS. 1 and 9, a set screw
34 is threaded into the passage 33 and engages the ribbon 28.
The handle 14 has a threaded end 36 of size to be threaded into the
open end of passage 33, as shown in FIG. 1. The threaded end 36 is
mounted on an elongated shaft or rod 37. The midsection of rod 37
has a pair of outwardly directed circular flanges 38 and 39.
Interposed between the flanges 38 and 39 is a triangular shaped
flexible sheet member 41. Member 41 is a flexible sheet of plastic,
rubber or like material used as a suture holder during the implant
procedure. Member 41 can have other shapes, as square, round, and
the like.
In use, as shown in FIGS. 8 and 9, the valve base 16 is positioned
on the face 24. The disc 18 is an open position with a portion of
the disc located in the recess 30. The flexible sheet member 26
extends upwardly through the passage 17 and over the ends 42 of
arms 19 and 21 and over the upper outer peripheral edge 43 of the
disc 18. The enlarged cover section 29 of the flexible sheet member
26 has a width and length sufficient to cover the opposite sides of
disc 18 as well as the outer ends 42 of the arms 19 and 21. The
ribbon 28 extends downwardly through the large opening 17 and
through the passage 31. The end of ribbon 28 extends transversely
through transverse passage 32. The flexible sheet member 26 is
pulled tight to firmly engage the sheet member with the arms 19 and
21 and disc 18. The set screw 34 is turned into transverse groove
33 to hold the ribbon in a taut condition. The extreme outer end of
the ribbon 28 is cut at 44, as indicated by broken lines in FIG. 9.
Each mitral valve is shipped in assembled relation with a
disposable collet 13. The valve is encased in the collet 13 so that
it can be implanted after sterilization.
There are a variety of successful methods of implanting heart
valves. Any of the standard methods are applicable to implantation
of pivoting disc valves. The following discussion is one technique
that can be used to implant the pivoting disc heart valve.
After the body cavity is opened, the heart is electrically
fibrillated and opened to expose the diseased heart tissue. The
diseased heart tissue is excised, leaving a 2-3 mm remnant of the
patient's own valve tissue. After the diseased valve tissue has
been removed, the proper size prosthesis is selected by visual
inspection aided by valve obturator sizers. The collet 13 on the
selected valve is then turned into the handle end 36.
The valve placement is facilitated by initially placing four stay
sutures equidistance about the annulus. A suture is placed at each
commissure and one at the midpoints therebetween. Mattress sutures
are placed in the heart tissue through the suturing collar and up
through the suture holder 41. The handle 14 is then used to slide
the heart valve into place within the annulus in the heart. The
sutures are then tied with the valve holder in place. The head 23
and the band 26 over the ends of the arms 19 and 21 and the disc 18
prevent the sutures from being snagged or looped over arms 19 and
21 or around the base 17. in addition, the band 26 functions as a
shield preventing the forcing of an arm into the heart tissue,
i.e., myocardium.
The holder 12 is removed from the valve by cutting the ribbon 28 at
the location 46 shown in FIG. 9. The collet 13 can be
longitudinally moved from the valve base. One section of the ribbon
is retained on the collet by set screw 34. The other section of the
band 26 attached to head 23 will move around the arms 19 and 21 and
disc 18, thereby eliminating the possibility of any foreign object
being lost in the heart chamber.
If there are any subannular abnormalitites that appear to interfere
with the free disc movement, the valve base can be rotated relative
to the suturing member to orient the disc away from calcifications.
The orientations of the disc is done after all of the stitches have
been tied. Preferably, the valve disc is oriented so that the
downward moving portion of the disc is toward the septum.
The atriotomy is then closed and the heart is allowed to restart by
removing the fibrillatory electrodes and defibrillating as
necessary.
While there has been shown and described a preferred embodiment of
the valve holding collet, it is understood that modifications,
changes in size and material may be made by those skilled in the
art without departing from the spirit of the invention.
* * * * *