U.S. patent number 3,727,240 [Application Number 05/191,617] was granted by the patent office on 1973-04-17 for suturing member for implantable devices such as heart valves.
This patent grant is currently assigned to Medical Incorporated. Invention is credited to Francis W. Child.
United States Patent |
3,727,240 |
Child |
April 17, 1973 |
SUTURING MEMBER FOR IMPLANTABLE DEVICES SUCH AS HEART VALVES
Abstract
A suturing member associated with an implantable device, as a
heart valve, for accommodating sutures to join the device to living
tissues. The suturing member has a porous fabric cover surrounding
a semi-rigid core of plastic material. The outer surface of the
plastic material is bonded to the inner surface of the fabric
cover.
Inventors: |
Child; Francis W. (Maple Plain,
MN) |
Assignee: |
Medical Incorporated
(Minneapolis, MN)
|
Family
ID: |
26887220 |
Appl.
No.: |
05/191,617 |
Filed: |
October 22, 1971 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
|
817988 |
Apr 21, 1969 |
3623212 |
|
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Current U.S.
Class: |
623/2.34 |
Current CPC
Class: |
A61F
2/2421 (20130101); A61F 2/2409 (20130101); A61F
2250/0003 (20130101) |
Current International
Class: |
A61F
2/24 (20060101); A61f 001/22 () |
Field of
Search: |
;3/1,DIG.3,DIG.1
;128/334R ;264/257 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: Frinks; Ronald L.
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATION
This application is a division of U.S. Patent application Ser. No.
817,988 filed Apr. 21, 1969, now U.S. Pat. No. 3,623,212.
Claims
The embodiments of the invention in which an exclusive property or
privilege is claimed are defined as follows:
1. A heart valve comprising: a base having an annular outside
portion and a passage allowing the flow of blood through the base,
valve means selectively movable relative to said base to open and
close the passage to control the flow of blood through the passage,
a suturing collar surrounding the outside portion of said base,
said collar having external cover means including porous material
for accommodating live heart tissue to form a union between the
cover means and heart tissues, said cover means having an inner
surface, annular continuous means located about and engaging an
annular portion of the inner surface to hold the cover means in
engagement with the outside portion of the base, and heat cured
core plastic material surrounded by said cover means, said core
plastic material having an outer surface bonded only to the inner
surface of the cover means and the continuous means during the heat
curing of the core plastic material.
2. The heart valve of claim 1 wherein: the annular continuous means
adjacent a portion of the inside surface of the cover means
includes cord means wrapped around the inside surface of the cover
means for holding the cover means on the base.
3. The heart valve of claim 1 wherein: the annular continuous means
engaging an annular portion of the inner surface of the cover means
is a wire.
4. The heart valve of claim 1 wherein: said cover means is a
plastic fabric cloth and said core material a fluorosilicone rubber
plastic, said fluorosilicone rubber plastic being bonded to the
fabric cloth.
5. The heart valve of claim 1 wherein: said suturing collar has an
annular outwardly directed flange.
6. A suturing member connectable to tissues of a living creature
mountable on an implantable device comprising: external cover means
including porous material for accommodating live tissues to form a
union between the cover means and the tissues, said cover means
having an inner surface, annular continuous means located about and
engaging an annular portion of the inner surface of the cover means
adapted to hold the cover means on the device, and heat cured core
plastic material located adjacent said cover means, said core
plastic material having an outer surface bonded only to the inner
surface of the cover means and the continuous means to form said
suturing member during the heat curing of the core plastic
material.
7. The suturing member of claim 6 wherein: said annular continuous
means comprises at least one cord.
8. The suturing member of claim 6 wherein: said annular continuous
means comprises at least one wire.
9. The suturing member of claim 6 wherein: the material of the
cover means is a synthetic fiber cloth and said core plastic
material is a fluorosilicone rubber.
10. The suturing member of claim 6 wherein: the cover means is an
annular synthetic fiber cloth and said core plastic material is
bonded to only the inner surface of the fiber cloth.
Description
BACKGROUND OF INVENTION
Implantable mechanical devices, as heart valves, are used to
replace natural portions of the various body organs. These devices
are provided with sewing members that are initially sutured to
surrounding living tissue. The sewing members have porous material
to take advantage of the natural fibrosis which can occur between
living tissue and the porous material. The porous material is
retained on the device in a number of ways. A clamp ring and wire
is shown in U.S. Pat. No. 3,099,016 to hold the sewing ring on the
heart valve. A stainless steel ring encased in porous material is
used in U.S. Pat. No. 3,396,409 to hold porous material on the
heart valve. These sewing rings do not join or bond the body or
core material to the porous cover material.
SUMMARY OF INVENTION
The invention is directed to a suturing member for implantable
devices and the method of making the same. The suturing member has
a cover means including biologically inert porous material for
accommodating live tissue ingrowth or fibrosis between the tissue
and porous material. The cover means surrounds a core of plastic
material bonded to the inner surface of the cover means to confine
body fluids and blood to the cover means. The plastic material does
not penetrate the porous material and interfere with tissue
ingrowth. The suturing member is made by locating uncured plastic
material within the cover means. After the cover means and uncured
plastic material have been shaped into the desired configuration,
the plastic material is cured to bond the plastic material to the
inside of the cover means.
An object of the invention is to provide a suturing member with a
flexible core that does not collect blood and body fluids and does
not interfere with tissue ingrowth into a porous cover bonded to
the core. Another object of the invention is to form a suturing
member directly on an implantable device in a manner which
eliminates blood-collecting spaces and cavities within the suturing
member. A further object of the invention is to provide a suturing
member which can be formed into a variety of shapes and which can
be universally applied to all types of implantable devices.
IN THE DRAWINGS
FIG. 1 is a plan view of a heart valve in assembled relation with
the suturing member of the invention;
FIG. 2 is a cross sectional view taken along the line 2--2 of FIG.
1;
FIG. 3 is an enlarged cross sectional view of the base of the heart
valve and suturing member;
FIG. 4 is an enlarged sectional view showing the first step of
assembling the cover on the base of the heart valve;
FIG. 5 is a view similar to FIG. 4 showing the placement of the
core of uncured plastic material around the cover;
FIG. 6 is a view similar to FIG. 4 showing the cover closed about
the core of uncured plastic material;
FIG. 7 is a sectional view showing the closed cover and encased
core of plastic material shaped in the curing mold;
FIG. 8 shows a modified tubular cover placed around the base of a
heart valve;
FIG. 9 is a view similar to FIG. 7 showing the filling of the
tubular cover with a core of uncured plastic material; and
FIG. 10 is a view showing the filled cover of FIG. 9 placed in a
curing mold to shape and to cure the plastic material.
Referring to the drawings, there is shown in FIGS. 1 and 2 a heart
valve, indicated generally at 15, having an annular base 16 with an
outwardly open annular groove 17 for accommodating a suture
fixation ring or sewing collar, indicated generally at 18. The
collar 18 provides a means of connecting the heart valve with the
heart tissue to hold the valve permanently in operative position.
The collar 18 has sufficent rigidity so that it does not flex when
hydraulic pressure is exerted against the valve. The suturing
member of the invention can be used to hold other artificial
devices permanently in operative positions in a living body or
creature. The following description is limited to collar 18 mounted
on a base of a toroidal heart valve, as shown in U.S. Pat. No.
3,438,394. Other types of heart valves, as ball valves, disk valves
and pivoting disk valves, can be equipped with the suturing collar
of the invention.
The heart valve 15 has an annular element 19 movable axially
relative to a circular opening in the base 16 to open and close the
opening in the base. Valve element 19 is a torus having a generally
elliptical shape in cross section with a continuous outer
peripheral surface 21 and a continuous inner peripheral surface 22.
When the element 19 is in the closed position, a circumferential
portion of the outer peripheral surface 21 engages a
circumferential seat 23 on the inside of the base surrounding the
opening.
Located along the longitudinal axis of the base 16 is a center
member 24 which cooperates with the valve element 19 to
substantially close the opening in the base restricting the flow of
fluid in one direction through the opening. Center member 24 has a
generally tear drop shape and is positioned centrally in the
opening in base 16. Circumferentially spaced radial legs 26 and 27
rigidly support the center member 24 on the base 16. A number of
legs or a single leg can be used to secure the center member 24 to
the base 16.
An open cage 28, extended upwardly from the base, directs the
movement of the valve element 19 and determines the open position
of the valve element. The cage means 28 comprises a plurality of
upright arms 29 having inwardly directed fingers 31. As shown in
FIG. 2, the fingers 31 function as stops for the valve element 19.
The open cage 28 permits the valve element 19 to have free floating
and rotational movement between its open and closed positions.
Referring to FIG. 3, there is shown the collar 18 in assembled
relation with the base 16. Collar 18 comprises a cover 32 of porous
material held in the groove 17 with a plurality of cords or threads
33. Located within the cover 32 is a body or core of plastic
material 34 bonded to the inside surface of the cover 32. Stitches
36 are used to secure opposite ends of the cover 32 together to
form a continuous cover member. The collar 18 has an outwardly
directed annular flange or cuff 37 providing a sewing ring for
attaching the valve to the heart tissue.
Cover 32 is a biologically inert, porous material that is
compatible with the chemicals and fluids of the body and does not
deteriorate with time. The material can be an interlaced or knitted
fabric to provide a mesh or spaces into which the living tissue
grows in the process of healing to form a permanent union with the
collar and the living tissue independently of the sutures applied
by the surgeon. The collar can be made entirely of a synthetic
fiber, as Dupont Teflon cloth or Dacron cloth. The cord 33 is a
wrapping thread, as Nylon thread, which firmly holds cover 32 in
the groove 17. The core material 34 is a pliable plastic material
in the uncured state that is compatible with with the human tissue
and body fluids. In addition, the core material 34 is sterilizable,
biologically inert, non-irritating and non-toxic to the body fluids
or body tissues. On curing the plastic material, a bond between the
inside surface or face of the cover and the plastic material is
achieved to eliminate any pockets or separation of the cover from
the core material which can collect blood and other body fluids.
The core material is preferably a plastic material, such as Dow
Corning Silastic, fluorosilicone rubber or a similar synthetic
resinous plastic material. The core material cures at a relatively
low temperature to a semi-rigid relatively nonelastic plastic which
retains its molded shape. The mold determines the ultimate shape of
the collar so that mitral and aortic collars can be made with
different molds.
Referring to FIGS. 4 to 6, there is shown the process of attaching
and forming the suture fixation collar on the base 16 of the heart
valve 15. Referring to FIG. 4, the cover 32 made into a cylinder or
sleeve is placed about the base 16. The cord 33 is wrapped about
the cover 32 tightly holding the cover 32 in the groove 17 of the
base 16. The cord may have a portion woven into the cover 32 to
provide a positive connection between the cords and the cover. The
uncured plastic core material 34, as shown in FIG. 5, is formed
into an elongated roll and uniformly placed around the cover 32
adjacent to the cords 33. The plastic core material, being uncured,
is in a relatively pliable and malleable state so that a measurable
amount of material can be extruded from a container or a press.
Preferably, the roll of uncured plastic core material is weighed so
that a determinative amount of material can be placed around the
cover 32.
Referring to FIG. 6, the cover 32 has been wrapped around the
plastic core material 34. The end portions of the cover 32 are
lapped and attached together with stitches 36. The stitches 36,
located closely adjacent to the base 16 extend all around the
base.
As shown in FIG. 7, the entire heart valve 15 with the uncured
suture collar 18 is placed within a mold 38 having a center cavity
39 joined with a peripheral annular cavity 41. The collar 18 is
pressed into the mold cavity 41 whereby the shape of the collar is
changed to conform to the mold cavity 41 to form the outwardly
directed peripheral flange 37. The collar 18 is located in the mold
cavity with a light force fit so that the cover 32 is in continuous
engagement with the plastic core material 34. The entire valve and
collar 18 are retained in the mold cavity with a cover or flat
plate 42. The core material 34 is cured by heating the mold for a
period of time. For example, with core material of Silastic, the
mold is heated for a period of 5 minutes at 220.degree. F. During
the curing process, the core material 34 bonds to the inside
surface, or face, of cover 32 to form a continuous and permanent
connection between the core material 34 and the cover 32. This bond
eliminates the spaces or cavities between the core material 34 and
the cover 32. The plastic core material 34 does not penetrate the
fabric of the cover whereby the cover retains the porous
characteristic and ability to have good tissue ingrowth. The
plastic core material 34 being nonabsorbent does not soak up blood
or other body fluids.
After the suture collar 18 is cured, the heart valve 15 along with
the collar 18 is removed from the mold 38. The relatively low
termperature of the curing of the plastic core material 34 does not
have any harmful effects on the metal valve base 16 or valve
element 19.
Referring to FIG. 8, there is shown a modified suture fixation ring
or collar 43 mounted on the base 16 of the heart valve. Base 16 has
an inwardly directed peripheral groove 17 accommodating the suture
fixation collar 43. Collar 43 comprises an annular cover 44
enclosing plastic core material 46. Cover 44 is of a fabric
material similar to the material of cover 32 shown in FIG. 3. The
plastic core material 46 is a mixture of the plastic core material
34 with evenly dispersed small plastic threads, as Nylon or Teflon,
to reinforce the plastic material. Preferably, the plastic core
material is a Silastic filled with small Teflon or Nylon
threads.
Referring to FIG. 9, the annular cover 44 is a tubular fabric
placed on the base 16 in groove 17. The cover 44, being a
continuous annulus, has approximately the same inside diameter as
the diameter of groove 17. As shown in FIG. 10, the plastic core
material 46 is placed into the cover 44 with an injector 47 to fill
an annular cavity within the cover 44. A measured amount of core
material is injected into the cover.
As shown in FIG. 10, the heart valve together with the collar 43
with the uncured plastic core material 46 is placed within a mold
48 having an annular cavity 49 of a shape outlining the final shape
of the fixation collar. The shape of the cavity may be altered as
required by the final shape of the suture fixation collar. The
uncured plastic material, being readily deformable, conforms to the
shape of the mold cavity. The collar 43 is forced into the cavity
so that it firmly positions the plastic core material 46 in surface
contact with the cover 44. The mold is closed with a lid or plate
51 to confine the suturing collar 43 to the mold cavity. The
plastic core material 46 is cured and bonded to the cover 44 on
application of heat to the mold. The plastic material 46 bonds to
the entire inside surface, or face, 45 of the cover 44 and does not
penetrate the fabric material of the cover, whereby the fabric
cover retains its tissue ingrowth capbilities.
While the invention has been described with respect to preferred
embodiments of the structure and processes of forming and joining a
suture fixation member to an artificial device implantable in a
body of a living creature, various changes in shape, size and
materials of the suturing member may be made by those skilled in
the art without departing from the spirit of the invention. For
example, cords 33 can be metal wire and the tubular annular cover
44 can be made of a heat curable plastic material having a high
concentration of fibers, as Teflon fibers. This cover can surround
a core material of reinforced plastic material. The fibers carried
in the cover provide cavities and spaces for the tissue ingrowth,
as well as provide a reinforcing for holding the suturing collar on
the artificial implantable device. The cover may surround only a
portion of the outer surface of the core plastic material leaving a
portion of the core plastic material exposed. Inserts of metal
and/or plastic members and the like rigid or semi-rigid members, as
wires, rods, tubes or cylinders can be encased or partially encased
in the plastic core material. Portions of the inserts may project
axially, laterally or outwardly from the plastic core material and
cover. The suturing member can be used with implantable devices
other than heart valves that are attachable to tissue and require
tissue ingrowth. Devices for connecting veins and arteries can be
provided with the suture fixation structure of the invention. The
device may have a portion made with the suturing member, as the
base of a heart valve.
* * * * *