U.S. patent number 3,628,535 [Application Number 04/875,989] was granted by the patent office on 1971-12-21 for surgical instrument for implanting a prosthetic heart valve or the like.
This patent grant is currently assigned to Nibot Corporation. Invention is credited to Aaron R. Best, Bart T. Heffernan, Efrem Ostrowsky.
United States Patent |
3,628,535 |
Ostrowsky , et al. |
December 21, 1971 |
SURGICAL INSTRUMENT FOR IMPLANTING A PROSTHETIC HEART VALVE OR THE
LIKE
Abstract
A valve insertion unit for holding a heart valve or like
prosthetic device to be inserted within the body, for engaging and
spreading an expansible valve-receiving ring previously implanted
in the body, for moving the valve into position within the ring,
releasing the ring over the valve and releasing the valve from the
holder. The valve holder is normally biased opened, fingers are
used to spread the ring and are biased to a normally closely
spaced-apart position, and movement of the holder along the fingers
while portions of the holder engage the fingers expands the ring.
When the holder, in an extreme axial position of travel, leaves the
ends of the fingers, the ring automatically snaps into position to
hold the valve in place within the body and the valve holder
releases it grip on the valve so the entire instrument may be
removed from the body.
Inventors: |
Ostrowsky; Efrem (Highland
Park, IL), Heffernan; Bart T. (Wilmette, IL), Best; Aaron
R. (Wheeling, IL) |
Assignee: |
Nibot Corporation (Lincolnwood,
IL)
|
Family
ID: |
25366724 |
Appl.
No.: |
04/875,989 |
Filed: |
November 12, 1969 |
Current U.S.
Class: |
604/303;
606/205 |
Current CPC
Class: |
A61F
2/2427 (20130101); A61B 50/20 (20160201) |
Current International
Class: |
A61F
2/24 (20060101); A61B 19/02 (20060101); A61B
19/00 (20060101); A61b 017/00 (); A61f
001/22 () |
Field of
Search: |
;128/303,341,326,345,334
;3/1,DIG.3 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: Frinks; Ronald L.
Claims
We claim:
1. A surgical instrument for use in inserting a prosthetic device
in a desired position of use at least partially within an
expansible retaining ring, said instrument comprising in
combination, means for engaging said ring on the interior thereof
and for spreading said ring apart upon radially outward movement of
said engaging means, means for receiving a valve for insertion
within said ring, said receiving means being normally biased to an
open position for release of a valve held therein and being adapted
to hold a valve therein in a closed position thereof, means
associated with said receiving means for expanding said
ring-spreading means by engagement therewith while said valve is
held within said receiving means, said receiving means and said
spreading means being arranged so that said valve may be moved by
said receiving means into a position of engagement with said ring,
and further movement of said receiving means removes said ring from
said engaging means and allows release of said spreading means from
said engaging means, whereby said valve may be released from said
receiving means upon engagement of said valve with said ring.
2. An instrument as defined in claim 1 in which said receiving
means comprises a split ring having an annular groove therein for
receiving a portion of said valve.
3. An instrument as defined in claim 1 in which said receiving
means comprises a ring having a groove therein for receiving said
valve and said spreading means comprises a plurality of openings in
said receiving means engagement with said engaging means, whereby
said engaging means are positioned so as to be in diametral
registry with said spreading means as said receiving means is moved
along said engaging means.
4. An instrument as defined in claim 1 in which said engaging means
comprises a plurality of stiff but resilient fingers attached to a
frame element, said fingers being biased toward a closely
spaced-apart position at the ends thereof opposite the ends thereof
which are received by said frame.
5. An instrument as defined in claim 1 in which said engaging means
comprises a plurality of fingers mounted in a frame and extending
axially therefrom, said receiving means comprises a split collar
having an annular groove therein for receiving a valve, and in
which said receiving means includes a plurality of openings therein
for engaging said fingers, and in which said receiving means
includes a pair of stiff but resilient fingers biasing said split
collar to an open position thereof, whereby said first-mentioned
fingers are urged apart by axial movement of said receiving means
and whereby engagement of said first-mentioned fingers with said
receiving means retains said receiving means in a closed position
thereof as long as said openings are engaged with said fingers.
6. A surgical tool for use in inserting a prosthetic device in a
desired position of use at least partially within an expansible
retaining ring comprising, in combination, a ring spreader assembly
including a ring spreader frame unit, a plurality of spaced apart,
elongated flexible ring-spreading fingers attached at the proximate
ends thereof to said frame unit and being biased toward and closely
spaced apart from one another at the remote ends thereof for entry
into the center of said expansible ring, a valve holder assembly
including a frame unit, a plurality of spaced apart, elongated
means for supporting a valve holder unit, said means being joined
at the proximate ends thereof to said valve holder frame unit and
being inherently biased apart from each other at the remote ends
thereof, a valve holder unit adapted to receive and hold a valve
therein when in a closed position, and to release said valve when
in an open position thereof, said supporting means being attached
at their remote ends to portions of said valve holder unit, said
valve holder assembly and said ring-spreader assembly being freely
axially movable in relation to each other, and means on said valve
holder unit for spreadingly engaging said fingers in one axial
position of said holder and for releasing said valve holder in
another axial position of said holder, whereby, during axial
movement of said valve holder along said fingers, engagement
between said holder unit and said fingers spreads said fingers
apart to expand said expansible ring engaged by said remote ends of
said fingers to allow insertion of said valve unit through said
ring in an expanded condition of said ring, and upon further axial
movement, said ring is engaged by said valve, and removed axially
from the ends of said fingers, whereupon said valve holder is
released from said fingers and allowed to open for release of said
valve therefrom.
Description
BACKGROUND OF THE INVENTION
The present invention is directed generally to surgical
instruments, and more particularly to a surgical instrument or tool
adapted to facilitate insertion of a prosthetic device such as a
replacement heart valve or the like into position within a person
or animal in a simple, rapid and accurate manner. More
particularly, in one embodiment, the invention is directed to a
tool for use during surgery to insert an atrio-ventricular into the
annulus fibrosis of the heart of a person.
Recently, as extensive and complex surgery becomes more common,
many attempts have been made to insure that a person or animal
being surgically operated upon undergoes the least exposure to
damage which is consistent with performing the steps necessary to
an operation. For example, as open heart surgery has become more
common, there has been a need not only for improved surgical
techniques and prosthetic devices to bring about the results
desired, such as methods of implanting improved synthetic heart
valves and the like, but also a need for means of assuring that the
surgical patient is exposed to potentially dangerous and damaging
conditions for the least possible time.
Thus, although it is now somewhat common to replace a damaged heart
valve, such as the atrio-ventricular heart valve, this surgery
requires that the heart be open and the blood of the patient be
circulated by artificial means. Artificial blood circulation pumps,
although satisfactory in general sense, are known by those skilled
in medicine to cause some measurable damage to the blood of the
patient, and therefore increase the likelihood that the patient
will suffer either immediate or eventual adverse affects from such
exposure.
Therefore, there has been a need for minimizing the time during
which the heart of a patient must remain open during surgery, and
attempts to satisfy this need have included the provision of heart
valves having improved means for implantation thereof. For example,
copending application Ser. No. 721,360 filed Apr. 15, 1968,
discloses a heart valve which is held in place by a resilient
snapring sewn into the annulus fibrosis of a patient before the
valve is inserted, and which then supports the valve in position
within the heart. This construction has significantly simplified
the suturing techniques heretofore, used, and as a result, has
decreased the time during which the heart must remain open during
surgery. This construction eliminates the time consuming formerly
used method of suturing the valve in place by a sewing cuff
attached thereto. The present invention is directed to providing an
instrument for spreading or stretching such a snapring to
facilitate insertion of a heart valve in place within the patient,
and thereby to reduce even further the time during which the
patient's heart must remain open during surgery.
Accordingly, an object of the present invention is to provide a
surgical instrument which is particularly useful in heart
surgery.
Another object is to provide a surgical instrument adapted to grip
a prosthetic device to support it during positioning, and to
release it in a desired position within the body.
Another object is to provide a surgical tool which is adapted to
engage and spread apart a snapring or the like to facilitate
insertion therein of a prosthetic device and to release the device
in a position to be engaged by the snapring when the ring is
released from a spread apart position.
A further object of the invention is to provide a device which
includes means thereon for engaging a snapring disposed within a
portion of a patient, and which is remotely operable to spread said
ring apart, and to move a valve held therein to a position of
engagement while simultaneously expanding the portions of the tool
engaged with the ring and holding together the valve receiving or
supporting element until a position of engagement between the valve
and the ring is reached.
In general, these objects are achieved by providing an instrument
comprising a valve holder element supported on resilient fingers
from a frame, ring spreading fingers attached to a second frame
unit, and means for providing engagement and release between the
spreading fingers and the holder so that moving the valve into
position spreads the ring for valve reception, and further movement
allows the ring to engage the valve just as the holder releases the
valve so the instrument may be withdrawn from the patient.
The exact manner in which this invention achieves its objects will
become more clearly apparent when reference is made to the
following detailed description of the preferred embodiments of the
invention, to the appended claims, and to the accompanying
drawings, in which like reference numerals indicate corresponding
parts throughout.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a perspective view of the surgical instrument of the
invention, showing the relation thereof to a portion of a patient
in whom a prosthetic device is being inserted;
FIG. 2 is a side elevational view of the instrument of the
invention, showing one position thereof;
FIG. 3 is a side elevational view showing the instrument in another
position of use; FIG. 4 is a sectional view, with portions broken
away, showing a prosthetic device held in the instrument being
inserted in place;
FIG. 5 is a view similar to FIG. 4, showing the prosthetic device
being released in position of use within the patient;
FIG. 6 is an end elevational view of the surgical instrument of the
invention; and
FIG. 7 is a side elevational view of the instrument shown in
another position of use.
DESCRIPTION OF THE PREFERRED EMBODIMENTS OF THE INVENTION
Although the surgical tool of the present invention is useful with
a number of different prosthetic devices and the like, the
invention will be described in reference to a preferred embodiment
in which a heart valve, for example, an atrio-ventricular heart
valve of the Edwards type, is held therein and disposed within an
expansible snapring previously sewn in position in the annulus
fibrosis of a human or animal heart.
Referring now in particular to FIG. 1, the surgical tool 10 is
shown to comprise means for engaging and spreading an expansible
ring in the form of a ring spreader assembly 12 and means for
receiving a synthetic heart valve in the form of a valve holder
assembly 14. The ring spreader assembly 12 includes a generally
ring-shaped frame unit 16, and a plurality of means in the form of
rods or fingers 18 for engaging and spreading apart an expansible
snapring 20, such as a silicone rubber or stainless steel snapring.
The remote ends 22 of the fingers 18 engage the ring 20 while the
proximate ends 24 of the fingers 18 are fixedly attached to the
frame 16. A valve 26 is removably held between an upper
semicircular collar 28 and a lower circular collar 30, which
combine to form valve-receiving means in the form of a holder 32.
Preferably, the collars 28, 30 are biased apart by a pair of valve
holder rods 34 which terminate at the proximate ends 36 thereof in
an annular ring 38 which serves as a frame for the valve holder
32.
An alignment ring 40 having a plurality of openings 42 therein, may
be disposed between the frame 16 and the holder 32 for receiving
the fingers 18, in a manner and for purposes which will be
described in further detail herein.
Referring now to FIGS. 2 and 3, it can be seen that the ends 22 of
the fingers 18 are normally biased to a closely spaced-apart
position by the inherent resiliency of the fingers 18, but that the
ends 22 thereof may be urged to a spaced-apart position such as
that shown in FIG. 2 by moving the upper and lower semicircular
collars 28, 30 which comprise the holder 32 axially of the fingers
18. This is accomplished because the openings 42 in the collars 28,
30 receive the fingers 18 and act as means for spreading them apart
upon axial holder movement which occurs when the frame 38 of the
valve holder assembly 14 is moved axially of the instrument 10
toward the ends 22 of the fingers 18.
In FIG. 3, it is shown that, when the entire holder assembly 14 is
moved to a sufficient axial extent, such as to the extreme right
hand position shown in FIG. 3, the collars 28, 30 move free of the
rod ends 22, thereby enabling the resilient, outwardly biased rods
34 to move the collars 28, 30 radially apart, and the ends 22 of
the fingers 18 to return to a closely spaced-apart position.
Referring now to FIGS. 4 and 5, a silicone rubber ring 20 is shown
as being sewn in place within the annulus fibrosis 44 of the
atrio-ventricular heart wall 46 by a plurality of sutures 48. The
interior of the ring 20 is engaged by the remote ends 22 of the
fingers 18, and this serves to spread the expansible ring 20 apart
a preset distance as the collars 28, 30 are moved toward the
axially remote ends 22 of the fingers 18. As shown in FIG. 4, the
valve 26 includes a nose portion 50, partially defined by a
plurality of supporting members 52 which also serve to cage a ball
54, which is the operational portion of the valve 26. Around the
exterior of the valve seat 56 is a ring-retaining groove 58,
partially defined by a shoulder portion 60 which is adapted to
engage the ring 20 to insure proper registry of the ring 20 in the
groove 58. A land 62 in the holder 32 releasably engages a second
shoulder 64 on the valve 26. Thus, the land 62 on the collars 28,
30 engages the valve 26 and holds it in position as long as the
collars 28, 30 are held closed by engagement between the openings
42 therein and the fingers 18.
FIG. 5 shows that, in operation of the device, as the extreme axial
movement limit of the collars 28, 30 is reached, the shoulder
portion 60 of the valve has engaged the ring 20 so that it is in a
position of registry with the groove 58 and the ring 20 cannot move
past the desired position. As the ends 22 of the fingers 18 undergo
relative movement with respect to the holder 32, and are withdrawn
into the openings 42, the ends 22 no longer engage the ring which
snaps into the groove 58 to support the valve 26 in a desired
position within the heart. Slight further movement of the collars
28, 30 with respect to the rod ends 22 allows the collars 28, 30 to
release the valve, and the entire unit is then withdrawn.
When it is desired to repeat the operating cycle for another
operation, a valve is placed between the collars 28, 30, the
collars are then closed, and the alignment ring 40 is moved towards
the remote ends 22 of the fingers 18, thereby spacing the ends 22
apart a distance equal to their spacing when engaged with the
openings 42. This allows the collars 28, 30 to be placed over the
fingers 18 in a simple operation and enables the entire valve
holder assembly, including a valve 26 held therein, to be moved to
the left as shown in the drawings. This permits the ends 22 of the
rods or fingers 18 to return to their closely spaced-apart position
for entry into the center of the ring. This action is illustrated
in FIG. 7, which shows a valve 26 held in the collars 28, 30, the
frame 38 moved to an extreme left-hand position, and the ends 22 of
the fingers 18 closely spaced apart.
In use, when the heart wall or membrane is open, the flexible
rubber or expansible steel snapring 20 is rapidly sewn directly
into place within the annulus fibrosis in the place from which the
natural atrio-ventricular valve has been removed. Since the ring 20
and the valve 26 to be inserted therein are separate pieces, the
valve does not interfere with the sewing operation. Immediately
after the ring is located and sewn in the desired position, the
ends 22 of the rods or fingers 18 are placed within the snapring 20
and the ring 38 is manipulated so as to move the valve into
position within the split ring 32 and subsequently released
therefrom in one operation, while the ring 20 is in registry with
the groove 58. The surgical instrument of the present invention
thus makes it possible to simplify heart surgery and greatly reduce
the time required for implantation of a valve within the heart,
thereby reducing the time during which the heart must remain open
and during which the blood of the patient is being circulated by
artificial means.
In a preferred embodiment, the unit is made of a stainless steel
construction for corrosion resistance, and ease of sterilization
even though the construction is such that other materials may be
used, particularly if a lower cost disposable unit is desired to be
made.
* * * * *