U.S. patent number 3,866,247 [Application Number 05/370,861] was granted by the patent office on 1975-02-18 for graft tubes.
Invention is credited to Charles Howard Sparks, deceased.
United States Patent |
3,866,247 |
Sparks, deceased |
February 18, 1975 |
GRAFT TUBES
Abstract
The invention is illustrated and described in connection with
the growing of a femoro-popliteal artery graft. A tunneling tube is
inserted through an incision above the inguinal ligament in the
groin area adjacent an upper portion of the femoral artery and
thrust downward subcutaneously through the thigh to a point below
the knee on the inner or medial side of the leg adjacent a lower
portion of the popliteal artery. A flexible silicone mandrel
assembly having two layers of knitted Dacron on a flexible silicone
rod is inserted in the tunneling tube. Then the tunneling tube is
removed and the incision closed. The patient resumes his normal
activity for a number of weeks during which time an ingrowth of
connective tissue incorporates itself in the Dacron mesh, making an
autogenous artery graft grown in the place where it is to be used.
In a second operation, a new incision is made below the inguinal
ligament to expose the upper end of the graft tube containing the
mandrel and an incision is made below the knee to expose the lower
end of the graft tube containing the mandrel. Both ends of the
graft and mandrel are cut off and the mandrel is pulled out. The
graft is then anastomosed to the femoral artery above and the
popliteal artery below, using the end-to-side method of
anastomosis. The closing of the two incisions completes the
operation with the graft providing a shunt for the femoro-popliteal
artery extending from the groin to a point below the knee.
Inventors: |
Sparks, deceased; Charles
Howard (LATE OF Portland, OR) |
Family
ID: |
26934076 |
Appl.
No.: |
05/370,861 |
Filed: |
June 18, 1973 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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241190 |
Apr 5, 1972 |
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101031 |
Dec 23, 1970 |
3710777 |
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241190 |
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175914 |
Aug 30, 1971 |
3710400 |
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823287 |
May 9, 1969 |
3625198 |
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655838 |
Jul 25, 1967 |
3514791 |
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Current U.S.
Class: |
600/36 |
Current CPC
Class: |
A61L
27/18 (20130101); A61F 2/062 (20130101); A61L
27/18 (20130101); C08L 83/04 (20130101) |
Current International
Class: |
A61F
2/06 (20060101); A61L 27/18 (20060101); A61L
27/00 (20060101); A61f 001/24 () |
Field of
Search: |
;3/1,DIG.1
;128/334R,334C,1R |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
Annals of Surgery, 159 : 819, 1964. .
"An Arterial Prosthesis Composed of an Autogenous Fibrocollagenous
Tube with Incorporated Polypropylene Mesh" by I. Assefi, and B.
Parsonnet, J. Newark Beth Israel Hosp., Vol. 15, pages 161-170,
1964. .
"Mesh-Reinforced Fibrocollagenous Tubes for Arterial Replacement,"
Journal of Newark Beth Israel Hosp., Vol. 17, 1966, pages
3-7..
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Primary Examiner: Gaudet; Richard A.
Assistant Examiner: Frinks; Ronald L.
Attorney, Agent or Firm: Schermerhorn; Lee R.
Parent Case Text
CROSS-REFERENCES TO RELATED APPLICATIONS
This is a continuation of application Ser. No. 241,190, filed Apr.
5, 1972, on GRAFT TUBES, now abandoned, which is in turn a division
of Ser. No. 101,031, filed Dec. 23, 1970, on METHOD AND APPARATUS
FOR GROWING GRAFT TUBES IN PLACE, now U.S. Pat. No. 3,710,777, said
Ser. No. 241,190 also being a continuation-in-part of Ser. No.
175,914, filed Aug. 30, 1971, on GRAFT MEMBER GROWN IN A LIVING
BODY, now U.S. Pat. No. 3,710,400; which is a division of Ser. No.
823,287, filed May 9, 1969, on DIE AND HOLDER FOR IMPLANTING IN A
LIVING BODY TO GROW TISSUE GRAFTS, now U.S. Pat. No. 3,625,198;
which is a continuation-in-part of Ser. No. 655,838, filed July 25,
1967, on TISSUE GRAFTS, now U.S. Pat. No. 3,514,791.
Claims
What is claimed is:
1. An autogenous graft tube comprising an ingrowth of connective
tissue from a living body in the permanently implanted part of a
mandrel assembly having a temporarily implanted part and a
permanently implanted part, said temporarily implanted part
comprising a flexible mandrel capable of bending with body
movements, and said permanently implanted part comprising a fabric
tube on said mandrel impregnated with a stiffening agent and a
layer of material inside of said fabric tube holding said fabric
tube spaced away from said mandrel, the entire outer surface of
said fabric tube being exposed to said ingrowth of connective
tissue, said ingrowth of connective tissue having a smooth cast
lumen formed by said mandral, and said graft tube having a
permanent blood supply established during the ingrowth of said
connective tissue.
2. A graft tube as defined in claim 1, said mandrel being made of
silicone rubber.
3. A graft tube as defined in claim 1, said layer of material
comprising a second fabric tube.
4. A graft tube as defined in claim 3, said second fabric tube
being of coarser mesh than said first fabric tube.
5. A graft tube as defined in claim 3, both of said fabric tubes
being impregnated with silicone rubber vulcanized in situ.
Description
BACKGROUND OF THE INVENTION
This invention relates to method and apparatus for growing graft
tubes in place.
Although artery grafts have been grown successfully in one part of
the body for use in another part of the same body, they have a
number of disadvantages. They require the implantation and removal
of dies and a relatively long growing time in the dies. They
require surgical operations on the two different parts of the body
involved. This entails a relatively long operating time and a
degree of pain to the patient which it is desirable to minimize.
The extent of the surgical operations enhances the danger of
infection. Die grown grafts must establish a blood supply after
implantation. When a long graft tube is needed, it is usually
necessary to anastomose several short tubes together.
Vein grafting also has many disadvantages. Quite often an adequate
vein is not available and frequently there is a serious question as
to whether an available vein is adequate to carry arterial
pressure. In the usual saphenous vein graft, multiple incisions and
a large amount of dissection must be done to remove the vein. This,
again, increases the time of the operation and the danger of
infection. Also, the vein graft is devascularized and requires time
to reestablish its blood supply.
Objects of the invention are, therefore, to provide an improved
method and apparatus for growing graft tubes, to provide a method
and apparatus for growing autogenous graft tubes in place, to
provide a method that will grow strong grafts which have
established their own blood supply during growth, to provide a
method which minimizes incisions and dissection and which
accordingly reduces the operating time and danger of infection, to
provide an autogenous graft tube which is tougher and stronger than
any other known autogenous graft tube, and to provide apparatus for
carrying out the method which is well tolerated by the body.
SUMMARY OF THE INVENTION
In the present method a tunneling tube is inserted in a small
incision and thrust through the body in such direction as to occupy
the position desired for the graft tube. A mandrel assembly
comprising a plurality of layers of knitted mesh on a flexible
plastic mandrel is inserted in the tunneling tube and then the
tunneling tube is withdrawn and the incision closed. The patient
can resume his normal routine of life while the graft tube is
growing as a result of the ingrowth of connective tissue into the
mesh of the knitted tubes. After a number of weeks the natural
process is complete, resulting in a graft tube which has
established its own blood supply.
In a second operation the mandrel is withdrawn and the ends of the
graft tube are connected to the intended natural tube or tubes. The
second operation requires only two incisions, at the opposite ends
of the graft tube, with a minimum of discomfort and convalescent
time on the part of the patient and a greatly reduced possibility
of infection.
The invention will be better understood and additional objects and
advantages will become apparent from the following description of
the preferred method and apparatus with reference to the
accompanying drawings. Various changes may be made in the details
of the method and apparatus and certain features may be used
without others. All such modifications within the scope of the
appended claims are included in the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is an elevation view of the tunneler used in practicing the
method of the invention;
FIG. 2 is an enlarged view of the distal end portion of the
tunneler with parts in section;
FIG. 3 is a front view of a patient's right leg and groin showing
the step of inserting the tunneling tube for a femoro-popliteal
artery graft;
FIG. 4 is a view similar to FIG. 3 showing the tunneling tube fully
inserted;
FIG. 5 is a side view of a portion of the leg in FIGS. 3 and 4
showing the position of the tunneling tube relative to the
knee;
FIG. 6 is a fragmentary perspective view showing the mandrel
assembly;
FIG. 7 is a front view similar to FIG. 3, showing the step of
inserting the mandrel assembly into the tunneling tube;
FIG. 8 is a view similar to FIG. 7, showing the step of removing
the tunneling tube;
FIG. 9 is a view similar to FIG. 8, showing the tunneling tube
removed;
FIG. 10 is a view similar to FIG. 4, showing the mandrel and
knitted coverings stretched preparatory to ligating them and
cutting them to length;
FIG. 11 is a view similar to FIG. 10, showing the completion of the
first operation with the incision closed and the mandrel assembly
in position to grow a graft tube;
FIG. 12 is a view similar to FIGS. 7, 8 and 9, showing a new
incision made in a second operation after a graft tube has grown on
the mandrel;
FIG. 13 is a view of a portion of FIG. 12, showing the new incision
opened to expose the upper end of the mandrel assembly;
FIG. 14 is a view similar to FIG. 13, showing the step of cutting
off the upper end of the graft and mandrel for removal of the
mandrel;
FIG. 15 is a side view similar to FIG. 5, showing a new incision
below the knee;
FIG. 16 is a similar view showing the step of cutting off the lower
end of the graft and mandrel;
FIG. 17 is a front view, showing the step of removing the mandrel
from the graft tube;
FIG. 18 is a similar view showing the anastomosis of the upper end
of the graft tube to an upper portion of the femoral artery;
and
FIG. 19 is a front view showing the completion of the second
operation.
DESCRIPTION OF THE PREFERRED EMBODIMENT
The invention will be described by way of example in connection
with the growing of a femoro-popliteal artery graft in situ. FIGS.
3 and 4 are front views of a human right leg having femoral artery
A which has become partially incompetent. The method is carried out
in two relatively simple surgical operations on the patient several
weeks apart.
The First Operation
The first operation involves the use of the tunneling tube 10 shown
in FIGS. 1 and 2. The tunneling tube comprises a metal tube 11
which for the present purpose has a slight bend at 12. Tube 11
contains a removable flexible core rod 13 preferably made of a
suitable plastic such as Teflon or Lexan. Core rod 13 has a rounded
distal end portion 14 which protrudes from the distal end of tube
11. The distal end of tube 11 is slightly inturned at 15 to provide
a snug sliding fit on the rod 13 which insures that the end of the
tube will be completely closed by the rod without leaving any
crevice or opening between the tube and the rod.
The proximal end of rod 13 is equipped with a handle portion 16
which abuts against the proximal end of tube 11 when the parts are
assembled as shown in FIGS. 1 and 2. The bend in the tube and the
snug fit against the rod at 15 provides sufficient friction to hold
the rod securely in the tube while at the same time permitting the
rod to be withdrawn from the tube. The purpose of rod 13 is to
provide a plug for the distal end of tube 11 which is removable
from its proximal end.
The first step of the first operation is to make an incision 20 in
the groin above the inguinal ligament and approximately overlying
the position of artery A as shown in FIG. 3. Tunneling tube 10
containing core rod 13 is inserted in incision 20 and forced
downward through the subcutaneous tissue of the leg in spaced
relation to artery A as indicated by arrow 21. The tunneling tube
is guided so that it will pass along the inside of the leg on the
inside and somewhat to the rear of the knee joint as shown in FIGS.
4 and 5 with the distal end of the tube extending a short distance
below the knee. Then the core rod 13 is withdrawn leaving tube 11
in the leg.
The next step is to insert mandrel assembly 25, in FIG. 6, into
tube 11 as shown in FIG. 7. Mandrel assembly 25 comprises a
flexible and elastic rod or mandrel 26 having a smooth surface and
made of a suitable plastic such as silicone rubber. Overlying the
mandrel are an inner coarse mesh fabric tube 27 and an outer fine
mesh fabric tube 28. These tubes are preferably knitted from a
suitable synthetic fiber such as Dacron.
By way of example for the present purpose, inner tube 27 may be
knitted on a sixteen needle knitting head using 70 denier Dacron
thread, and outer tube 28 may be knitted on a 22 needle knitting
head using the same thread. After knitting, both tubes 27 and 28
are dipped in a xylene suspension of silicone rubber and hung to
dry. The rubber coats and impregnates the thread but does not close
the mesh openings in the fabric.
Tube 27 is then stretched on a polished steel rod having a diameter
approximately 0.020 inch greater than the diameter of mandrel 26,
and tube 28 is stretched on a polished steel rod having a diameter
approximately 0.052 inch larger in diameter than mandrel 26. The
two rods are placed in an oven to vulcanize the silicone rubber
contained in and on the Dacron thread. Upon removal from the rods,
the tubes 27 and 28 do not change in length or diameter, the
vulcanized rubber imparting a starched effect to the fabric.
Tube 27 is then placed on mandrel 26 and tube 28, which has an
inside diameter about 0.012 inch greater than the outside diameter
of tube 27, is placed over the latter tube forming the mandrel
assembly 25 shown in FIG. 6. A silk ligature 29 is used to tie
fabric tubes 27 and 28 onto both ends of mandrel 26. This prevents
slippage and also prevents runs forming in the knitted
material.
Mandrel assembly 25 is inserted in tunneling tube 11 as shown in
FIG. 7. Then tunneling tube 11 is withdrawn, as shown in FIG. 8,
leaving mandrel assembly 25 in the leg as shown in FIG. 9.
By applying exterior pressure on the skin over the mandrel assembly
at point 30 in the region of the knee as shown in FIG. 10, the
fabric tubes 27 and 28 and the silicone mandrel 26 are stretched
upward and a third silk ligature 31 is applied as shown, allowing
the excess length of tubes 27 and 28 and the silicone mandrel 26 to
be cut off at 32. The upper ends of tubes 27 and 28 and the
silicone mandrel 26 in FIG. 10 will then pull back into the
incision by their elasticity and the incision 20 may be sutured
closed as shown in FIG. 11.
Since the incision 20 in the first operation just described amounts
to little more than a stab wound, it heals quickly and the patient
may leave the hospital in a day or so and resume his normal
activities while a graft tube is growing on mandrel 26. The mandrel
has approximately the same flexibility as a normal femoral artery
under arterial pressure whereby the mandrel assembly does not
impede movements of the knee joint or interfere with any other
activity of the patient.
Connective tissue grows into the fabric tubes 27 and 28, filling
the space between tube 27 and mandrel 26, and filling the space
between tubes 27 and 28, forming a strong, soft, flexible,
reinforced tissue tube with a wall thickness of approximately 0.025
inch to 0.030 inch in 5 to 8 weeks. The presence of the coarse mesh
tube 27 within the fine mesh tube 28 provides space for the growth
of an adequate thickness of tissue inside the outer tube 28 to
insure against rupture when the graft is put into use. Thus, a tube
of tissue grows in the coarse mesh of tube 27 within the outer
fabric tube 28. Inner tube 27 serves as a spacer to hold outer tube
28 away from the mandrel. Outer tube 28 is the primary strength
imparting element. The lining surface of the tissue which forms
against the smooth surface of mandrel 26 is smooth and shiny as
desired for an artery lumen.
The Second Operation
When the graft has matured, the patient returns to the hospital and
in a second operation a new incision 40 is made below the inguinal
ligament and overlying the femoral artery A as shown in FIG. 12.
Incision 40 is opened to expose the upper end of mandrel assembly
25 as shown in FIG. 13, and the end of the graft and mandrel are
cut off on an angle as indicated at 41 in FIG. 14.
An incision 50 is made below the knee as shown in FIG. 15 and the
lower end of the graft and mandrel are cut off on an angle as
indicated at 51 in FIG. 16. Mandrel 26 is withdrawn from tubes 27,
28 and the graft structure as shown in FIG. 17. The remaining graft
tube is identified by numeral 45 in FIG. 18 wherein the upper end
of the graft tube has been connected in an end-to-side anastomosis
at 46 with femoral artery A.
In FIG. 19 the part of the operation below the knee is completed
with the lower end of graft tube 45 connected with artery A in an
end-to-side anastomosis and both incisions 40 and 50 having been
closed.
Graft tube 45, being completely vascularized and mature, provides a
shunt which is immediately functional to bypass the incompetent
portion of artery A and provide an adequate supply of blood to the
lower leg. Again, the patient may be released from the hospital in
a very short time and requires only a convalescent period at home
sufficient to heal the new incisions 40 and 50.
The first operation described above requires about 10 minutes and
the second operation about 1 and 1/2 hours. They are both simple
operations, the first requiring only one incision and the second,
two incisions. This compares with a difficult three and one-half to
four hour operation with multiple incisions according to the
conventional practice of removing and reversing a saphenous vein as
a replacement for an incompetent femoral artery.
The method and apparatus of the invention may also be used to
connect one artery with another artery. For example, the common
femoral arteries on opposite sides have been interconnected in
selected instances of obstruction of one iliac artery with the
opposite one patent. A tunnel is made between the two groins in the
subcutaneous layer of the lower abdominal wall. A graft tube is
grown in the tunnel and anastomosed end-to-side to each common
femoral artery.
In another example an axillary artery (in the arm pit) has been
connected to the common femoral artery on the same side by a graft
tube grown in situ in a tunnel. In this patient the aorta and iliac
arteries in the abdomen were so severely diseased or embedded in
scar tissue as to make it impossible or impractical to reestablish
blood supply through them to the lower extremity. This in essence
takes part of the blood supply to the arm and diverts it to the
leg.
It is also within the scope of the invention to use the present
graft tubes for other purposes such as veins, esophagus, ureters,
bile ducts and trachea. Further, the invention is not limited to
growing graft tubes in situ. The mandrel assembly in FIG. 6 is
equally well adapted for growing transplantable graft tubes which
may be autogenous, homologous or heterologous. For example,
autogenous graft tubes have been grown in tunnels in the
subcutaneous layer of the chest wall using this mandrel assembly,
the graft being removed and transferred to another part of the body
for use. Graft tubes grown in this way have been used to replace a
segment of the aorta and to replace the iliac arteries.
In this connection the mandrel assembly in FIG. 6 may be implanted
with or without the use of the tunneling tube in FIG. 1 and, in the
latter case, the mandrel assembly may be made in Y configuration to
grow a bifurcation graft. By making the smaller limbs of the Y less
than half the diameter of the large limb, the smaller limbs of the
mandrel may be withdrawn through the large limb of the graft tube.
Such a bifurcation graft has been used for replacement of the lower
abdominal aorta and iliac arteries, for example.
* * * * *