U.S. patent number 3,894,530 [Application Number 05/376,948] was granted by the patent office on 1975-07-15 for method for repairing, augmenting, or replacing a body conduit or organ.
Invention is credited to Herbert Dardik, Irving I. Dardik.
United States Patent |
3,894,530 |
Dardik , et al. |
July 15, 1975 |
Method for repairing, augmenting, or replacing a body conduit or
organ
Abstract
The umbilical cord is used for grafts in the vascular system or
other body conduits, such as the ureter.
Inventors: |
Dardik; Irving I. (Tenafly,
NJ), Dardik; Herbert (Teaneck, NJ) |
Family
ID: |
23487154 |
Appl.
No.: |
05/376,948 |
Filed: |
July 6, 1973 |
Current U.S.
Class: |
600/36;
623/1.41 |
Current CPC
Class: |
A61L
27/3625 (20130101); A61L 27/507 (20130101); A61L
27/3641 (20130101) |
Current International
Class: |
B29C
65/56 (20060101); B29C 65/62 (20060101); A61L
27/36 (20060101); A61L 27/00 (20060101); A61B
019/00 (); A61F 001/24 () |
Field of
Search: |
;3/1,DIG.1,1.4
;128/334R,334C,335.5,335,1R |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
"The Use of Umbilical Cord for Reconstruction of Abdominal Wall
Defects" by Frederick C. Heaton et al., Surgical Forum, Vol. 21,
1970, pp. 56-57. .
"Preparation and Use of Freeze-Dried Arterial Homografts" by O.
Creech et al., Annals of Surgery, Vol. 140, No. 1, July, 1954, pp.
35-43..
|
Primary Examiner: Frinks; Ronald L.
Attorney, Agent or Firm: Blum Moscovitz Friedman &
Kaplan
Claims
I claim:
1. A method for repairing, augmenting or replacing a vein or artery
of the body of a primate which comprises suturing or otherwise
securing a portion of a vein or artery of an umbilical cord of a
primate into or onto the wall of such body vein or artery.
2. A method as described in claim 1 wherein the umbilical cord is
from a human infant.
3. A method as described in claim 1 wherein an artery of the body
is repaired, augmented or replaced.
4. A method as described in claim 1 wherein the cord is from a
human and said body is that of a primate other than the donor.
5. A method as described in claim 1 wherein a vein of the body is
repaired, augmented or replaced.
Description
A major problem in vascular reconstructive surgery is how
effectively to supply blood to organs and tissues whose blood
vessels are inadequate either through congenital defects or
acquired disorders such as trauma, arteriosclerosis and other
diseases. Various techniques and materials have been devised to
excise and replace blood vessels, to bypass blood vessels, and to
patch, i.e., widen the channel of vessels. Initially arterial
homografts (human arteries) were used to restore continuity but
limited supply, inadequate sizes, development of aneurysms and
atherosclerosis necessitated the search for a better substitute. A
great advance was the development of the partially porous and
pliable plastic cloth graft.
The following is a list of the various problems which one runs into
with artificially made grafts:
1. Infection in a foreign body graft is catastrophic, often leading
to hemorrhage, sepsis and death.
2. The inner lining is thrombogenic, predisposed to clotting of the
graft and distal embolism of the clot.
3. The rigidity of cloth grafts may result in twisting and kinking,
especially in areas of crossing a joint.
4. Because of clotting difficulties, smaller caliber artificial
grafts are frequently unsuccessful.
The many problems posed by artificially manufactured prostheses
have led investigators again to seek newer and better methods.
These include new techniques of "cleaning out" an artery such as
carbodissection, widening arteries by dilatation, development of
bovine heterografts, creating collagen tubes within the recipient
patient for later use as a graft (Silicone Mandrel).
Saphenous veins, both autografts (patient is donor) and allografts
or homografts (from another human), are now being used to
advantage. However, there are problems of unavailability, small
size, non uniform caliber, time required for harvesting,
intraluminal valves and easy twisting leading to occlusion. The
number of new methods being continually devised attests to the need
for a better material.
According to the present invention, the structures of the human
umbilical cord are used for grafts in the vascular system or other
body conduits such as the ureter, in mammals, particularly
primates, including man. At birth, after division from the baby,
the cord itself is traditionally discarded. The umbilical cord is
composed of a vein and two arteries surrounded by a substance
called Wharton's jelly. It varies in length from inches to almost 2
feet. It is highly flexible and strong. Both arteries and the vein
are suitable for use in surgery. Composite grafts and patches can
be made in various sizes and shapes. A list of uses follows, either
as a conduit or as a patch of any kind in the body:
1. Arterial substitute
2. Vein substitute
3. Ureter substitute
4. Common bile duct substitute
5. As an arteriovenous fistula for hemodialysis
6. As a patch to close any visceral or vascular defect, or to wrap
around and protect a suture line of any kind.
The umbilical cord may be used fresh or as a stored homograft
(frozen or in a preservative). It may require treatment with
antibiotics or other chemicals or drugs and x-ray treatment for
sterilization. It may be antigenic and require treatment, for
example with enzymes, to remove any antigenic substances. The cord
may be freeze dried or stored in a cold environment or preserved in
other known ways as to be used as an autograft if necessary for the
baby whenever needed at a future date. The cord may be somewhat
coiled and may require mechanical or chemical techniques to
straighten it out if necessary. Cords from premature babies or from
early pregnancy can be used (i.e., in smaller vessels).
The advantages of using umbilical vessels as a conduit or a patch
are as follows:
1. easy availability
2. marked flexibility
3. marked strength
4. highly smooth, natural inner lining may inhibit clotting
5. less likely to become infected
6. relative lack of antigenicity
7. uniform diameter
8. variable size available for both large and small vessels
9. good length
10. contains 3 vessels each of which can be used
EXAMPLE
The following example illustrates the technique of vascular
surgical interposition of the umbilical cord vessel derived from
the human, into the abdominal aorta of an animal, for example a dog
and a baboon.
The animal, in this case a baboon, was prepared under general
anesthesia and sterile conditions for making an abdominal incision.
The baboon was prepared and shaved and a longitudinal incision was
made in the midline of the abdomen. The incision extended from the
xythoid to the pubic area and was carried down through the midline
and into the peritoneal cavity. Bleeding vessels were clamped and
ligated with 3-0 plyglycollic acid sutures. The peritoneal cavity
was entered and the viscera and bowel were explored for any other
diseases. The animal was found to be normal. The bowel and viscera
were walled off with cloth pads and retractors. The peritoneum
overlying the aorta was incised and the aorta immobilized by sharp
and blunt dissection. Lumbar arteries were individually clamped and
ligated with 3-0 silk suture so that the segment of abdominal aorta
extending from the infra-renal arteries to the bifurcation of the
aorta was immobilized. The entire segment of abdominal aorta was
thus made available for transplant of the umbilical cord. During
preparation of the abdominal aorta of the baboon, another
investigator had taken the umbilical cord of an infant (human) that
had been born two hours prior to the surgical intervention of the
baboon. The cord had been delivered and taken in its entirety and
transported in sterile saline solution, packed in ice. The purpose
of freezing the umbilical cord in ice was to prevent any further
decomposition of the cord structure. The cord, prior to insertion,
was washed and irrigated numerous times with sterile Collins
solution with antibiotics, in this particular instance, 1 percent
cephalosporin solution and 25,000 units of bacitracin per liter of
solution. The blood was thoroughly washed out from within the
vessels of the cord and the cord was also irrigated with a 1
percent heparin anticoagulant solution. Following this thorough
cleansing of the cord, one end of the umbilical vein within the
cord which was to be used as the transplant was clamped with a
clamp and through the other end a red rubber catheter, No. 14
French, was introduced and the vein was distended. At this point a
suitable segment of umbilical graft, approximately 5 centimeters in
length, was selected for excision. This segment of cord was then
sterilely handled and placed into the operating field. At this
point the animal was heparinized with 2,500 units of aqueous
heparin given intravenously. The abdominal aorta was then clamped
proximally and distally to the segment to be resected. A segment of
approximately 3 centimeters in length was resected from the
abdominal aorta and an end-to-end anastomosis was performed between
host aorta and donor umbilical vein, first using continuous 6-0
prolene suture which is a nylon monofilament suture. The distal
anastomosis was then performed following flushing of the aorta to
rid it of any clot material and debris. Following completion of
anastomosis the distal and then the proximal clamps were removed.
It was noted that there was no bleeding between the interstices of
the sutures, which is unusual, and is felt to be due to the
strength and self-sealing gelatinous qualities of the cord
structure. Excellent pulses were noted to be present in the graft
as well as the distal iliac vessels. The area was lavaged with with
saline and suctioned. The retroperitoneum was closed with
interrupted 3-0 polyglycollic acid sutures and the viscera was
replaced. The animal, throughout the procedure thus far, was
stable; the respiration and vital signs were normal. The abdominal
wall was then closed in layers using continuous 0 silk for the
posterior fascia and peritoneum and interrupted 2-0 silk sutures
for the anterior fascia. The skin was approximated with continuous
3-0 nylon suture. The anesthesia used in this procedure was
nembutal. The blood loss estimated during the procedure was
approximately 50 to 75 cc. The animal tolerated the procedure well
and awoke within 30 minutes. Postoperatively on the following day
the animal was sitting and walking in its cage, and on the third
postoperative day was eating its regular diet and was allowed out
of its cage to roam around and climb up and down the walls, and
appeared to be in excellent health. The legs were warm and pulses
were intact in the extremities.
A number of procedures will become apparent to those skilled in the
art. If desired or necessary, the vein or artery of the umbilical
cord may be split longitudinally and formed into composites of
larger diameter. The umbilical cord or a portion thereof may be
used to reinforce, support or seal a weakened area or defect of any
body structure, such as the heart, the heart valves or urinary
bladder. Such procedures are included within the scope of the
claims.
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