U.S. patent number 3,860,005 [Application Number 05/394,482] was granted by the patent office on 1975-01-14 for collet for holding heart valve.
Invention is credited to Lawrence Anderson, Bruce D. Bentzen.
United States Patent |
3,860,005 |
Anderson , et al. |
January 14, 1975 |
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. Secured to 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) |
Family
ID: |
26964441 |
Appl.
No.: |
05/394,482 |
Filed: |
September 5, 1973 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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287420 |
Sep 8, 1972 |
3828787 |
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Current U.S.
Class: |
606/1;
606/107 |
Current CPC
Class: |
A61F
2/2427 (20130101) |
Current International
Class: |
A61F
2/24 (20060101); A61b 017/00 () |
Field of
Search: |
;128/303,92 ;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", 8th Biennial Cardiac Congress, July 1972, Durban,
South Africa..
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Primary Examiner: Gaudet; Richard A.
Assistant Examiner: Yasko; J.
Parent Case Text
CROSS REFERENCE TO RELATED APPLICATION
This application is a continuation-in-part of U.S. Ser. No.
287,420, now U.S. Pat. No. 3,828,787.
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 a
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 means having a first portion secured to said
head, means located in said head to secure the first portion to
said head, said elongated means extended through the passage and
positionable over the arm means and disc, and means to secure a
second portion of the elongated means to the body to hold the
elongated means in position over the arm means and disc.
2. The collet of claim 1 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, said groove being located in
one side of the portion of the head and said first portion attached
to and extended from the side opposite said one side.
3. The collet of claim 1 wherein: the head has an opening for
accommodating a first portion of the elongated means, said opening
in the head being located adjacent said groove, said body having a
passage aligned with the opening in the head for receiving a second
portion of the elongated means, said means to secure the elongated
means in the body extended into the passage in the body and
engageable with the second portion of the elongated means to hold
the elongated means in position over the arm means and the
disc.
4. The collet of claim 1 wherein: the elongated means is an
elongated flexible sheet member having an enlarged section
positionable over the arm means and disc and a ribbon section, said
means securing the sheet member to the body comprising means
engageable with the ribbon section.
5. The collet of claim 1 wherein: the means located in the head is
a member embedded in said head and the elongated means is a sheet
member having a portion cooperating with said member to secure the
sheet member to the head.
6. The collet of claim 1 wherein: the body, the head and elongated
means are made of plastic material and the means located in the
head is a metal member.
7. A collet for holding a heart valve having a base, a passage
through the base, valving means movable for movement 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, an elongated means having a first portion secured to
said body and extended adjacent the portion of the body engageable
with one side of the base, means located in said body to secure
said first portion to said body, said elongated means extended
through the passage in the base and adapted to cooperate with the
heart valve to hold the base on the body, said elongated means
having an end section, and means engageable with the end section to
secure the end section to the body.
8. The collet of claim 7 wherein: the body has a head with an
outwardly directed annular section, said section having an annular
portion engageable with one side of the base of the valve when the
valve is mounted on the collet, said means for accommodating a
portion of the valving means comprising a groove located in one
side of the portion of the head and said elongated means attached
to and extended from the side opposite said one side of the
head.
9. The collet of claim 8 wherein: said head has an opening for
accommodating a first portion of the elongated means, said opening
in the head being located adjacent the means for accommodating a
portion of the valving means, said body having a passage alinged
with the opening in the head for receiving a second portion of the
elongated means, said means to secure the elongated means to the
body extended into the passage in the body and engageable with the
second portion of the elongated means to hold the elongated means
in a fixed position.
10. Th collet of claim 7 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.
11. The collet of claim 7 wherein: the elongated flexible means is
an enlongated flexible sheet member having an enlarged section,
said end section being an elongated ribbon section attached to the
enlarged section.
12. The collet of claim 7 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
said end section of the elongated means, said means engageable with
the end section being located in the longitudinal passage.
13. A collet comprising a body having a head, said head having an
annular portion and a face, a first groove through said head open
to said face, a second groove in said head open to said face
adjacent to said first groove, elongated means secured to the head,
said elongated means having an end section extended through said
first groove, and means engageable with the end section extended
through said first groove to secure the end section to the
body.
14. The collet of claim 13 wherein: said body is an elongated
cylindrical member having means to attach the body to an elongated
handle.
15. The collet of claim 14 wherein: the head has an outwardly
directed annular section at one end of the body.
16. The collet of claim 13 wherein: said body has a passage aligned
with the first groove in the head for receiving the end section of
the elongated means, said means engageable with the end section
extended into the passage and engageable with the end section.
17. The collet of claim 16 wherein: said body is a cylindrical
member having a longitudinal passage open to said passage in the
body, said means engageable with the end section being located in
the longitudinal passage.
18. The collet of claim 13 wherein: the elongated means is an
elongated flexible sheet member having an enlarged section, said
end section being an elongated ribbon section attached to the
enlarged section.
19. The collet of claim 13 wherein: a member is embedded in said
body, the elongated means is a flexible sheet member having a
portion cooperating with said member to secure the sheet member to
the body.
20. The collet of claim 19 wherein: the body, head and flexible
means are made of plastic material, and said member is metal.
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 eliminate the possibility of snagging
a stich 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. Pat. No. 3,737,919. 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 pivot
structures and 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 hand is positionable over
the arm means implanted. 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 stich over an arm and forcing the 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 implated. 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;
FIG. 9 is a sectional view taken along line 9--9 of FIG. 8;
FIG. 10 is a plan view of a modified collet of the valve holder of
the invention;
FIG. 11 is a side elevational view of FIG. 10;
FIG. 12 is an elevational view of the right end of FIG. 10;
FIG. 13 is a fragmentary side view, partly sectioned, of the
collet;
FIG. 14 is an enlarged sectional view taken along the line 14--14
of FIG. 10;
FIG. 15 is a top plan view of a heart valve mounted on the collet;
and
FIG. 16 is a sectional view taken along line 16--16 of FIG. 15.
DESCRIPTION OF THE PREFERRED EMBODIMENT
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 heart surgery.
Heart valve 10 is a pivoting disc valve as shown in U.S. Pat. No.
3,486,143 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 and pivot members 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.
Head 23 has a pair of holes 25 providing passages through the head
to minimize blood pressure buildup across the valve during the
implant procedure. 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, connection
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 slightly larger
than 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. When the disc 18 is in the open position, it does
not rest on the bottom of groove 30 so that the disc 18 does not
hold the base 16 off the surface 24 of head 23. 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
aligned or in registration 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 a 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 in 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., mycardium.
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 abnormalities that appear to interfere
with free disc movement, the valve base can be rotated relative to
the suturing member to orient the disc away from calcifications.
The orientation 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.
Referring to FIG. 10, there is shown a modified collet 113 useable
with the handle 14 of FIG. 1 to position a heart valve in the heart
and hold the valve in position during surgery.
Referring to FIG. 16, 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. 16, the disc 18 is in its open position with a
small opening 17A on one side of the disc and a large opening 17B
on the opposite side of the disc. A pair of side arms 19 and 21
project upwardly from base 16 in the direction of the opening pivot
movement of the disc 18 and cooperate with separate portions of the
outer peripheral edge of the disc 18 and pivot members to retain
the disc in free floating pivotal relation with the base 16.
Returning to FIGS. 10 to 14, the collet 113 has a cylindrical body
122 of plastic material, as Teflon or Delrin. The upper end of body
122 has an enlarged circular head 123. The top of the head has a
flat surface or face 124. Face 124 has a diameter equal to the
outside diameter of the proximal side of the base 16, as shown in
FIG. 16. Face 124 has an annular flat surface that engages the
proximal side of the base 16.
An elongated flexible sheet member or band 126 is joined to the
head 123 with connecting section 127. As shown in FIGS. 14 and 16,
connection section 127 is secured to head 123. The band 126 is a
flexible plastic strap, as Teflon, made separately from the body
122. During the molding of the plastic body 122, connecting section
127 is molded into the head. Section 127 has a portion 127A mounted
on a metal member 125. Member 125 has a downwardly directed hub or
post 125A extended through a hole in portion 127A. Metal member 125
is molded into head 123 to firmly secure the band 126 to the body
122. Band 126 has a longitudinal ribbon or tail 128 extended
longitudinally from an enlarged cover section 129. Section 129 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. 15.
As shown in FIGS. 14 and 16, the head 123 has a groove or
semi-circular recess 130 in the side opposite the connecting
section 127. Groove 130 extends generally parallel to the
transverse extent of section 127 and has an arcuate configuration
slightly larger than the curvature of the outer peripheral edge of
the disc 18 and a slight inward incline. Groove 130 accommodates a
peripheral portion of the disc 18, as shown in broken lines in FIG.
13, to hold the disc in an inclined open position when the valve is
mounted on the collet 113. When the disc 18 is in the open
position, it does not rest on the bottom of groove 130 so that the
disc does not hold the base 16 off the surface 124 of head 123.
Located adjacent the groove 130 is an opening or groove 131. Groove
131 has a side wall extended from surface 124 downwardly at a
slight outward angle through head 123. The upper portion of body
122 has a transverse passage 132. One end of passage 132 is aligned
or in registration with the groove 131. Body 122 has a longitudinal
threaded passage 133 open to the transverse passage 132. As shown
in FIG. 16, a set screw 134 is threaded into the passage 133 and
engages ribbon 128. The handle 14 has a threaded end 36 of a size
to be threaded into the open end of passage 133, as shown in FIG.
1.
In use, as shown in FIGS. 15 and 16, the valve base 16 is
positioned on the face 124. The disc 18 is in an open position with
a portion of the disc located in the recess 130. The flexible sheet
member 126 extends upwardly through the large opening 17A of the
passage 17 over the upper outer peripheral edge 43 of the disc 18
and over the ends 42 of the arms 19 and 21. The enlarged cover
section 29 of the flexible sheet member 126 has a width and length
sufficient to cover the opposite sides of the disc 18 as well as
the outer ends 42 of the arms 19 and 21. The ribbon 128 extends
downwardly through the small opening 17B of passage 17 and through
groove 131. Groove 131 provides a passage through the head 123 to
minimize blood pressure buildup across the valve during the implant
procedure. The end of ribbon 128 extends trasversely through
transverse passage 132. The flexible sheet member 126 is pulled
tight to firmly engage the sheet member with the arms 19 and 21 and
the disc 18 and the side wall of groove 131. The set screw 134 is
turned into transverse groove 133 to hold the ribbon in a taut
condition. The extreme outer end 128A of the ribbon 128 is cut at
144, as indicated by broken lines in FIG. 16. Each mitral valve is
shipped in assembled relation with a disposable collet 113. The
valve is encased in the collet 113 so that it can be implanted
after sterilization. The valve can be implanted in a heart with
collet 113 by the procedure described with reference to the valve
shown in FIG. 1. The head 123 and the band 126 over the ends of the
arms 19 and 21 and the disc 18 prevent the sutures placed in the
sewing ring from being snagged or looped over arms 19 and 21 or
around the base 17. In addition, the band 126 functions as a shield
preventing the forcing of an arm into the heart tissue.
The collet 113 is removed from the valve by cutting the ribbon 128
at the location 146 shown in FIG. 16. The collet 113 can be
longitudinally moved from the valve base. One section of the ribbon
128 is retained in the collet 113 by set screw 134. The other
section of the band 126 attached to head 123 will move through the
small opening 17A, around arms 19 and 21 and dics 18 and through
the large opening 17B, thereby eliminating the possibility of any
foreign object being lost in the heart chamber.
While there have been shown and described preferred embodiments of
the valve holding collets, it is understood that modifications,
changes in size and material can be made by those skilled in the
art without departing from the spirit of the invention.
* * * * *