U.S. patent number 3,625,198 [Application Number 04/823,287] was granted by the patent office on 1971-12-07 for die and holder for implanting in a living body to grow tissue grafts.
Invention is credited to Charles H. Sparks.
United States Patent |
3,625,198 |
Sparks |
December 7, 1971 |
DIE AND HOLDER FOR IMPLANTING IN A LIVING BODY TO GROW TISSUE
GRAFTS
Abstract
Method and apparatus for growing a graft structure, particularly
in a patient's own body. A die cluster is disclosed comprising a
plurality of dies for growing graft tubes whereby such graft tubes
may be connected together end to end to make a tube of desired
length. The invention also includes an improved method for
implanting the die cluster in the body.
Inventors: |
Sparks; Charles H. (Portland,
OR) |
Family
ID: |
25238322 |
Appl.
No.: |
04/823,287 |
Filed: |
May 9, 1969 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
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655838 |
Jul 25, 1967 |
3514791 |
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Current U.S.
Class: |
600/36; 264/137;
606/132; 425/89; 623/916 |
Current CPC
Class: |
A61F
2/06 (20130101); A61L 27/18 (20130101); A61L
27/18 (20130101); C08L 83/04 (20130101); A61F
2/062 (20130101); Y10S 623/916 (20130101) |
Current International
Class: |
A61F
2/06 (20060101); A61L 27/00 (20060101); A61L
27/18 (20060101); A61b 019/00 (); A61f
001/24 () |
Field of
Search: |
;3/1,DIG.1
;128/1,92,334R,303 ;249/205 ;18/14R,14G,3PM,3PR,42R,1 ;132/38 |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
Ear Molds, Peer type, Catalog No. 6452, Vitallium Surgical
Appliances, Austenal Laboratories, Inc. Surgical Div., 224 E. 39th
St., N.Y. N.Y., p. 20, March 1948. Copy available in Group 335,
3-1..
|
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: Frinks; Ronald L.
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATION
This application is a continuation-in-part of my copending
application, Ser. No. 655,838, filed July 25, 1967, for TISSUE
GRAFTS now U.S. Pat. No. 3,514,791.
Claims
Having now described my invention and in what manner the same may
be used, what I claim as new and desire to protect by Letters
Patent is:
1. A die for forming a tissue graft comprising an outer perforated
tube and a mandrel therein defining an annular die cavity for
growing a graft tube, and a reinforcing member in said annular die
cavity positioned adjacent said outer tube and remote from said
mandrel for encapsulation by connective tissue growing through the
perforations in said outer tube, said reinforcing member comprising
a cloth tube impregnated with silicone rubber vulcanized in
situ.
2. A die cluster comprising a holder and a plurality of tissue dies
whereby said cluster may be implanted as a unit in a living body
for growing tissue grafts in said dies, and means securing said
dies in said holder arranged for individual removal of the dies
from said holder while said holder remains implanted, said dies
comprising perforated tubes and said holder comprising an anchor
rod having cross bars on its opposite ends supporting said die
tubes for said individual removal.
3. A die cluster as defined in claim 2, one of said crossbars being
removable from said anchor rod and the other crossbar having hinged
end portions.
4. A die cluster as defined in claim 3, said anchor rod
interconnecting central portions of said crossbars and additional
removable tie rods interconnecting the ends of said crossbars.
5. A die cluster as defined in claim 4 including additional rods
supported by said crossbars between said anchor rod and tie rods, a
mandrel in each die tube defining an annular die cavity in the
tube, and ferrules on said anchor rod and additional rods
supporting said mandrels and die tubes.
6. In an apparatus for growing a tissue graft, a die holder
comprising an anchor rod, a hinged crossbar mounted on one end of
said anchor rod, a pair of tie rods detachably connected at one end
with the opposite ends of said crossbar, and a second crossbar
detachably connected with the opposite ends of said rods.
7. An apparatus as defined in claim 6 including perforated die
mounted on said anchor rod, and a pair of additional perforated
dies supported by said crossbars between said first die and said
tie rods.
8. A die for growing a tubular tissue graft comprising a tube
having perforations in the wall thereof for the ingrowth of
connective tissue from a living body when said die is implanted in
said body, an axial mandrel in said tube defining an annular die
cavity in the tube, and a stiff cloth tube reinforcing member in
said die cavity disposed adjacent said tube and spaced from said
mandrel to allow said connective tissue to grow through said cloth
and fill the space between the cloth and said mandrel to form a
graft tube having said reinforcing member encapsulated adjacent the
outer surface of the graft tube and spaced outwardly from the lumen
of the graft tube.
9. A die as defined in claim 8, said cloth tube being stiffened by
impregnation with a stiffening agent.
10. A die as defined in claim 9, said stiffening agent comprising
silicone rubber.
11. A die as defined in claim 8, said mandrel being tubular, and a
rod extending through said mandrel to support said die.
Description
BACKGROUND OF THE INVENTION
This invention relates to a novel method and apparatus for growing
tissue grafts and has particular reference to a die cluster for
growing a plurality of grafts and to a novel method of implantation
of the die cluster in the body.
My prior application, identified above, discloses a number of
individual dies for growing grafts for different purposes. It is
often desired to grow a plurality of grafts at the same time, as
for example, when a graft tube is needed of greater length than can
be provided in a single implantable die. Also, the need may arise
to grow different sizes or types of grafts simultaneously.
Further, an improved technique for implantation is desired. It
would be advantageous to obviate the necessity for tying the die or
dies to the bone structure of the body and to provide a method of
implantation which would not require a large incision.
Objects of the invention are, therefore, to provide an improved
tissue graft, to provide an improved cloth reinforcement for a
tissue graft, to provide an improved arrangement of a cloth
reinforcement within a die cavity, to provide an improved die for
forming a tissue graft, to provide a novel die cluster for growing
a plurality of tissue grafts simultaneously, and to provide an
improved method for implanting a die or die cluster for growing the
grafts.
SUMMARY OF THE INVENTION
According to the present invention a cloth-reinforcing member is
impregnated with a stiffening agent so that the cloth may be
preshaped and will maintain itself in a position in a die cavity
where it will be located adjacent the outer surface of the graft
tissue. When a plurality of grafts are needed a number of dies are
assembled in a die cluster for implantation as a unit.
Instead of tying the die or die cluster to the rib cage to avoid
movement in the body, it is inserted under a layer of muscles
overlying the rib cage. The muscles themselves hold the die or die
cluster in fixed position against the ribs whereby the dies are
easily insertable and removable through a relatively small
incision.
Other objects and advantages will become apparent and the invention
will be better understood with reference to the following
description of the preferred embodiment illustrated in the
accompanying drawings. Various changes may be made, however, in the
details of the method and in the form of construction of the dies
and certain features may be used without others. The invention is
of particular advantage in growing autogenous grafts within the
body of the same patient who is to receive the grafts but the
invention may also be used in growing homografts and heterografts
if desired.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a perspective view of a die cluster embodying the
principles of the invention;
FIG. 2 is an exploded view of the die cluster in FIG. 1 with parts
removed and parts broken away;
FIG. 3 is a sectional view on the line 3--3 in FIG. 1;
FIG. 4 is a sectional view on the line 4--4 in FIG. 1;
FIG. 5 is a fragmentary front elevation view of a patient, showing
the die cluster of FIG. 1 implanted;
FIG. 6 is an enlarged view of a portion of FIG. 5 showing the use
of a pathfinder for preparing an opening to receive the die
cluster;
FIG. 7 is a view similar to FIG. 6 showing a first step in the
removal of the dies;
FIG. 8 is a view similar to FIG. 7 showing a subsequent step in
removal of the dies;
FIG. 9 is an enlarged view of a portion of FIG. 8 with parts in
section;
FIGS. 10 and 11 are views similar to FIGS. 7 and 8 showing
subsequent steps in removal of the die cluster;
FIG. 12 is a fragmentary perspective view showing a preliminary
step in removal of a graft from a die; and
FIG. 13 is a similar view showing the final step in removal of a
graft from a die.
DESCRIPTION OF THE PREFERRED EMBODIMENT
FIG. 1 shows a die cluster 10 containing a plurality of dies 11 for
implantation as a unit. By way of example, tubular dies are
illustrated for growing artery grafts and the like. Each die
comprises essentially an outer cylindrical metal tube 12 containing
perforations 13 and an inner cylindrical metal mandrel 14 of
smaller diameter. The annular space between the outer surface of
the mandrel and the inner surface of tube 12 forms a die cavity 15
for growing a tube graft. Tube 12 and mandrel 14 may be made of a
suitable plastic if desired.
Each tube 12 and mandrel 14 is supported at its front end on a
plastic ferrule 20 and at its rear end on a plastic ferrule 21. In
the middle die of the cluster these ferrules are mounted on an
anchor rod 22 while in the two outside dies the ferrules are
mounted on removable rods 23. The two ferrules 21 on rods 23 are
secured thereto by pins 24 while the other ferrules are not
attached to their supporting rods. Each ferrule has a stepped end
flange portion 25 to support tube 12 and an interior shoulder
portion 26 supporting mandrel 14 in concentric position within tube
12. Flange 25 on each ferrule 20 has the same diameter as the
outside diameter of tube 12 while flange 25 on each ferrule 21 is
of larger diameter for a purpose which will presently appear.
Mounted on the rear end of anchor rod 22 is a head 30 having hinge
pins 31 for pivotal connection with crossbars 32. The outer end of
each crossbar 32 is provided with a threaded hole 33 and its
intermediate portion is provided with a smooth hole 34. The rear
ends of rods 23 are received in the holes 34 and a pair of tie rods
35 have threaded engagement with the end holes 33.
The assemblage thus far described is retained in the cluster by a
front crossbar 40. Crossbar 40 has a central hole 41 to receive
anchor rod 22, end holes 42 to receive tie rods 35, and
intermediate holes 43 to receive the removable rods 23, all of
these holes being smooth bore. The front ends of rods 22 and 35 are
threaded at 44 to receive nuts 45. Nuts 45 hold all the parts in
place and immobilize the hinged joints at 31 to form a rigid
relatively flat unit for implantation. Crossbars 32 and 40 and rods
22 and 35 form a frame or die holder which contains the dies 11 in
side-by-side relation.
In order to prevent adherence of the graft to the mandrel 14 the
outer surface of the mandrel is preferably coated with a suitable
release agent such as Dow Corning resin R-671 or Teflon. To
strengthen the graft a cloth-reinforcing member 50 is inserted in
die cavity 15. Member 50 is preferably made of woven or knitted
seamless tubular construction having such diameter that it will lie
against or substantially adjacent outer tube 12 in spaced relation
to mandrel 14. The structural advantages and disadvantages of both
woven and knitted materials are well understood by persons skilled
in the art. Tube 50 is preferably made of a suitable synthetic
fiber such as Dacron. This reinforcement is most effective to
prevent leakage or rupture of the graft under arterial blood
pressure if the reinforcement is located adjacent the outer surface
of the graft tube and relatively remote from the inner surface or
lumen.
In order to make the cloth tube 50 support itself and lie
substantially smoothly against the inside of tube 12, the cloth is
preferably impregnated with a suitable stiffening agent such as
silicone rubber. A preferred procedure is to dip the tube several
times in a 1:5 suspension of crude (unvulcanized) silicone rubber
in xylene. The tube is hung to dry between dips. It is then
stretched on a glass rod having a diameter equal to the inside
diameter of tube 12 and vulcanized in stretched condition. This
accomplishes a desirable sizing operation. When the cloth tube is
removed from the glass rod it holds its diameter, and when
installed in the die it automatically positions itself snugly
against the inner surface of tube 12. Impregnation and
vulcanization in the manner described also causes the cloth tube to
hold its length and causes the junctures of the threads to become
locked together, both of which stabilizing factors are especially
advantageous with a knitted type of cloth.
Before implantation of the die cluster the die cavities are
preferably filled with a suitable nutrient. A preferred method of
preparing the nutrient will be described. The quantities given in
the following example are not intended to limit the invention but
will serve to define the preferred proportions of the ingredients
used. First, 50 cc. of the patient's blood is drawn from a vena
puncture into a syringe containing 2 cc. of a solution of one
million units of penicillin and one gram of streptomycin dissolved
in 20 cc. of normal saline solution. Then an assembled and sterile
die cluster as shown in FIG. 1 is placed in a metal laboratory boat
and covered with the blood solution just described. The die cluster
is allowed to remain in the blood solution for about 25 minutes so
that a strong, firm clot forms, filling the die cavities 15.
FIGS. 5 and 6 illustrate the method of implantation of the prepared
die cluster. A transverse incision A is made in the skin
immediately above the costal margin across the mid clavicular line
as shown in FIG. 5. This incision is carried down to the serratus
anterior muscle. If the patient is right-handed this incision is
made on the left side, as shown; if the patient is left-handed the
incision would be made on the right side. In instances where two
long graft tubes are needed, a die cluster is implanted on each
antrolateral chest wall.
After incision A has been made in the skin, the serratus anterior
muscle is incised in the direction of its fibers as indicated at B
in FIG. 5. A flat spatula-shaped pathfinder 60 is inserted and
passed on the rib cage superomedially, aiming at the junction of
the middle and medial thirds of the clavicle as shown in FIG. 6. In
the proximal one-half of the passage considerable resistance is met
as a result of the origins of the serratus anterior muscle. These
must be pushed forcefully off the ribs. Essentially no resistance
is met as the instrument passes beneath the pectoralis major muscle
in the upper half of the passage. Then the pathfinder 60 is
withdrawn.
The die cluster 10 prepared as above described is lifted from the
boat and the back end having the jointed crossbar 32 is inserted in
the same manner as pathfinder 60 in FIG. 6. The die cluster is
pushed up along the path made by pathfinder 60 until the lower end
of the die cluster lies above incision A as shown in FIG. 5.
Finally, the incision is closed in layers using interrupted sutures
and a light sterile dressing is applied. The patient is maintained
on penicillin and streptomycin until hospital discharge. The
patient is normally discharged from the hospital 1 or 2 days after
implantation of the dies and resumes normal activity. The die
cluster may be made to contain fewer or more than three dies if
desired.
The serratus anterior muscle and the pectoralis major muscle clamp
the die cluster firmly and rigidly against the ribs and prevent any
movement of the die cluster, making it unnecessary to provide any
mechanical attachment to the ribs. This makes it possible to insert
and remove the die cluster endwise through a relatively small
incision which heals quickly. While the die cluster is implanted,
body tissue from the patient grows through holes 13 into the die
cavity replacing the blood nutrient and encapsulating the
reinforcing cloth tube 50. This ingrowth of tissue completely fills
the die cavity and forms the ultimate graft. Mandrel 14 casts a
smooth surface on the lumen of the graft tube.
Two or 3 months later the patient is readmitted to the hospital for
the grafting procedure. The grafts are usually complete in 2 months
and are consistently complete at 3 months. The procedure for
removing the dies is shown in FIGS. 7 to 11. A 3 inch incision C is
made over the lower end of the die cluster and perpendicular to its
long axis. This incision is carried down through the muscle to the
dies. Lower crossbar 40 and the lower 1 cm. of the dies are exposed
by sharp dissection. Nuts 45 are removed and crossbar 40 is removed
as shown in FIG. 7, and tie rods 35 are unscrewed from threaded
holes 33 in hinged crossbar 32.
Then a cylindrical cutter 65 is passed onto the exposed end of a
die and, using a rotary oscillating motion, is passed up over the
entire length of the die as shown in FIGS. 8 and 9. The larger
diameter flanges 25 on plastic ferrules 21 provide stops for the
cutter. This operation severs the necks of tissue 66 which have
ingrown through the holes 13 in tube 12. The cutter and die are
then removed and the die containing the graft is removed from the
cutter. The remaining two dies are removed in the same manner. In
removing the dies, rods 23 come out with the dies while anchor rod
22 remains in the patient.
At this stage only the center anchor rod 22 and the upper jointed
crossbar 32 remain in the patient as shown in FIG. 10. These parts
are removed by firm traction on the anchor rod as shown in FIG. 11,
causing the ends of crossbar 32 to pivot back to trailing position,
as shown. Incision C is closed in layers using interrupted silk
sutures.
Using a surgical knife, the outer surface of each tube 12 is
completely cleansed of all fragments of tissue and the mandrel 14
is extracted from each die. This is done by pushing the mandrel
from one end to expose its other end which is then grasped with a
small hemostat and extracted.
A gall bladder probe 70 is then passed between the graft G and the
inner surface of tube 12 at several points around the circumference
as shown in FIG. 12. With each pass, it is passed throughout the
length of the die, releasing the graft from the outer tube by
withdrawing the necks of tissue 66 inwardly through the holes 13.
After the graft is completely freed from tube 12 in this manner, it
may be grasped at one end with a hemostat and extracted as shown in
FIG. 13.
When a long graft tube is needed, the individual grafts from the
three dies may be sutured together end to end over a glass rod, the
ends of the grafts preferably being cut on a 45.degree. angle for
each anastomosis. In this manner a graft tube approximately 19
inches long may be made.
When only a short graft is needed, a single die similar to the
central die is used with a modified form of die holder. In such
case, crossbar 40 and hinged crossbars 32 are made shorter and
holes 34 and 43 are omitted. This makes a narrower and more compact
unit placing the tie rods 35 adjacent opposite sides of the single
die on anchor rod 22. When the die is round, the die holder
prevents rotation in the body. When the die and die holder are of
small size, the unit may simply be inserted in a stab wound
directed as explained in connection with FIGS. 5 and 6.
The invention is not limited to tube grafts. Dies for other graft
members may also be implanted essentially as described in
connection with FIGS. 5 and 6. When the die is not round, the die
holder may be eliminated if desired but a die holder may still be
desirable for convenience in handling a single die or cluster of
dies.
* * * * *