U.S. patent number 3,683,926 [Application Number 05/053,454] was granted by the patent office on 1972-08-15 for tube for connecting blood vessels.
This patent grant is currently assigned to Dainippon Pharmaceutical Co., Ltd.. Invention is credited to Jiro Suzuki.
United States Patent |
3,683,926 |
Suzuki |
August 15, 1972 |
TUBE FOR CONNECTING BLOOD VESSELS
Abstract
A tube readily soluble into blood and useful as the support for
connecting blood vessels, which is made of a composition comprising
70 to 90 percent by weight of sucrose, 6 to 25 percent by weight of
a crystallization inhibitor therefor and 2 to 10 percent by weight
of an elasticizer, shaped in a cylinder, T-letter or Y-letter form,
tapered at both ends and provided grooves or protuberances
circumferentially on the outer surface. The present invention
relates to a tube for connecting blood vessels. It also relates to
a method for preparation of such tube. It further relates to a
method for connecting blood vessels by the aid of such tube. Suture
technique of blood vessels was started by Hovoch early in 1800.
Recently, further progress in small vascular surgery was made by
Jacobson who introduced microstructure technique, and stapling
technique has been developed with various new stapling instruments
too. But, usual apparatuses of stapling or suture technique are not
applicable to intracranial vascular surgery, because these
apparatuses are too large to manipulate in very small operative
fields. In addition, there is a danger of injuring to other
surrounding important tissues such as cranial nerves, brain tissues
and many small vessels. In order to apply even to deeply located
blood vessels as cerebral ones, attempts have been made on
non-suture vascular anastomosis utilizing plastic adhesives, which
is easy to manipulate and less time consuming and does not need any
large supplementary instruments. In such non-suture vascular
anastomosis, a support material shaped in, for instance, tube or
rod is inserted to the lumens of both vascular ends, a plastic
adhesive is applied to this anastomotic portion and blood flow is
re-established so that, after a while, the support material
dissolves into blood. As understood from such technique, the
support material should meet at least the following three
requirements: (1) exerting no material toxicity on living bodies
such as animals and human beings; (2) having such rigidity as can
be readily inserted into vascular lumens; and (3 ) being soluble
with ease into blood so as to recover smooth flow of blood as early
as possible. Although various materials and shape have been
proposed for such support, satisfaction has been not fully obtained
on any proposal. As the result of the study for a long time, it has
now been found that a certain composition comprising sucrose as the
main component meets the said requirements and is an ideal material
for such support. On this finding, there has been produced a tube
made of the said composition and shaped in such form as being
easily inserted in and difficultly slipped out of vascular lumens,
and it has been confirmed that the vascular anastomosis can be
accomplished quite successfully in various blood vessels including
diseased vessels like atherosclerotic arteries and deeply located
vessels as cerebral ones. The present invention is based on these
finding and confirmation. Accordingly, a basic object of the
present invention is to embody a tube useful as the support on
non-suture vascular anastomosis. Another object of this invention
is to embody a method for preparation of such tube. A further
object of the invention is to embody a method for connecting
vascular vessels by the aid of such tube. A still further object of
the invention is to embody a composition suitable for preparation
of such tube. These and other objects of the invention will be
apparent to those conversant with the art to which the present
invention pertains from the above and subsequent descriptions.
Inventors: |
Suzuki; Jiro (Sendai,
JA) |
Assignee: |
Dainippon Pharmaceutical Co.,
Ltd. (Osaka-shi, Osaka-fu, JA)
|
Family
ID: |
21984351 |
Appl.
No.: |
05/053,454 |
Filed: |
July 9, 1970 |
Current U.S.
Class: |
606/154; 623/1.1;
606/155 |
Current CPC
Class: |
A61B
17/11 (20130101); A61B 2017/1107 (20130101); A61B
2017/1139 (20130101); A61B 2017/1135 (20130101) |
Current International
Class: |
A61B
17/11 (20060101); A61B 17/03 (20060101); A61b
017/11 () |
Field of
Search: |
;128/334R,334C,335.5,348
;3/1 ;424/35 ;99/138 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Other References
Andrews et al. - Surgery, Vol. 66 No. 3-pp. 535-539 Sept.
1969.
|
Primary Examiner: Truluck; Dalton L.
Claims
What is claimed is:
1. A tube for connecting blood vessels which is made of a
composition comprising 70 to 90 percent by weight of sucrose, 6 to
25 percent by weight of a crystallization inhibitor selected from
the group consisting of glucose, lactose and maltose, and 2 to 10
percent by weight of an elasticizer selected from the group
consisting of dextran and dextrin on the basis of the total weight
of the composition.
2. The tube according to claim 1, wherein the composition comprises
an antimicrobial agent.
3. The tube according to claim 1, wherein the composition comprises
a blood coagulation inhibitor.
4. The tube according to claim 1, wherein the blood coagulation
inhibitor is mucopolysaccharide or heparin.
5. The tube according to claim 1, wherein the tube is shaped in a
cylinder form.
6. The tube according to claim 1, wherein the tube is shaped in a
T-letter form.
7. The tube according to claim 1, wherein the tube is shaped in a
Y-letter form.
8. The tube according to claim 1, wherein the tube is tapered to
the ends.
9. The tube according to claim 1, wherein grooves are provided
circumferentially on the outer surface of the tube.
10. The tube according to claim 1, wherein protuberances are
provided circumferentially on the outer surface of the tube.
Description
The following is a brief description of the drawings. FIG. 1 shows
the front views of the tubes which are three typical embodiments of
the invention. That is, FIG. 1 (A) shows a cylindrical tube FIG. 1
(B) shows a T-letter shaped tube and FIG. 1 (C) shows a Y-letter
shaped tube.
FIG. 2 illustrates the steps for connecting blood vessels according
to the present invention. FIGS. 2 (A) and (B) show, respectively,
two blood vessels to be connected each other at the section surface
and a spindle tube (same as shown in FIG. 1 (A) ) to be used as the
connection between the blood vessels.
FIG. 2 (C) shows the intermediate state for connection wherein both
ends of the tube are inserted into the lumens of the blood vessels.
FIG. 2 (D) shows perfection of the insertion wherein two ring clips
are placed on the outer surfaces of the blood vessels. FIG. 2 (E),
shows the state after accomplishment of the connection where the
tube dissolved and disappears into blood flow.
The tube of the present invention is made of a composition
comprising sucrose as the main component, a crystallization
inhibitor therefor and an elasticizer.
As the crystallization inhibitor, there are exemplified glucose,
lactose, maltose, etc. Examples of the elasticizer are dextran,
dextrin, etc.
The weight ratio of the components affects the solubility in blood
flow and the mechanical strength of the resulting tube and may be
varied with the place to which the tube is applied. Usually, the
composition includes 70 to 90 percent 90by weight of sucrose, 6 to
25 percent by weight of the crystallization inhibitor and 2 to 10
percent by weight of the elasticizer on the basis of the weight of
the composition. The most preferable weight ratio at present is
sucrose : the crystallization inhibitor : the elasticizer = 80 : 16
: 4.
In addition to the said essential components, the composition may
include an antimicrobial agent, a blood coagulation inhibitor
(e.g., mucopolysaccharides, heparin) and any other additive.
For preparation of the tube using such composition, the said
essential components with or without the said optional components
are first dissolved into water. The resultant solution is heated up
to 150.degree. to 170.degree. C. Heating above 170.degree. C is not
favorable, because caramelization is caused and the caramelized
product is not suitably used for the object of the invention. The
heated solution is then cooled to about 60.degree. C for obtaining
a soft, glassy material, from which a long pipe is drawn in the
same manner as adopted on the manufacture of a glass pipe. The pipe
is then cut at a proper length to make numerous pieces of tubes,
each of which is then preferably tapered at both ends so as to be
easily inserted to vascular ends and also favorably provided with
grooves or protuberances circumferentially on the outer surface for
preventing from slipping out of vascular ends.
Alternatively, the soft, glassy material may be shaped directily
into a tube by the use of a mold. In this case, the tapering and/or
the formation of grooves or protuberances may be accomplished
simultaneously.
The thus obtained tube is of hard, glassy quality and usually
stored under the condition prevented from moisture.
Prior to storage or use, the tube may be dipped in a solution of
the antimicrobial agent and/or the blood coagulation inhibitor and
then dried to make a film of such agents on the surface.
A practical and presently-preferred embodiment of the invention is
illustratively shown in the following Example.
EXAMPLE
A solution of 80 g of sucrose, 16 g of glucose and 4 g of dextrin
in 200 g of water is gradually heated up to 160.degree. C and then
allowed to stand for cooling. After cooled to 80.degree. C, the
solution is kept in a warming room and gradually cooled to about
70.degree. C. After removal of a hard film formed on the surface,
an appropriate amount of the resultant soft, glassy material is
attached uniformly around a cylindrical stick made of
polytetrafluoroethylene ("Teflon") or glass (linoleic acid being
applied previously on the surface in the latter case) so as to make
a layer of 6 mm in thickness. When cooled to about 60.degree. C,
the stick is taken off, and the resultant hollow material is drawn
to the directions of both ends while heating the central or trunk
portion of the said material so as to make a pipe of 1 to 5 mm in
outer diameter. The pipe is cut by alcoholic vapor without
affording any change on the inner diameter into some pieces of
tubes, each tube being 10 to 20 mm in length. A heated silver or
platinum wire is contacted on the surface of the tube, and the tube
is gradually rotated so that a groove is formed curcumferentially
on the surface. In the same manner, another groove is provided on
the surface at a distance from and parallel to the said groove. The
grooved tube is irradiated under ultraviolet sterilization lamp and
stored in a desiccator. The tube is readily soluble in water,
sparingly soluble in anhydrous ethanol and materially insoluble in
benzene, toluene, ether, fats and oils.
Some of the experiments on the connection using the above prepared
tube are shown below.
EXPERIMENT 1
The tube of the invention was inserted to each one end of two vinyl
tubes to be connected each other and, after applying an adhesive to
the section surface of the vinyl tubes, they were brought into
contact each other by the section surface. Then, stored blood at
37.degree. C was flowed to the connected vinyl tube at a pressure
of 130 mmHg. The tube of the invention dissolved completely within
40 seconds.
EXAPERIMENT 2
Common carotid arteries, femoral arteries and femoral veins of 2.0
to 4.0 mm in external diameter from 23 mongrel dogs weighing 4 to
11 kg were subjected to the experiment.
After transection of the artery occluded by two clamps, adventitia
of vascular ends was stripped. The lumens of the vessels were
irrigated with dilute heparinized saline solution. The tube of the
invention having the same diameter as the internal diameter of the
vessel was inserted to the both vascular ends. These ends were
connected closely by the tube and two polyethylene sheathed clips
were laid at the point of grooves of the tube from outside for
fixation. Excessive blood and moisture at the anastomotic portion
were removed by using a sponge and a very small amount of an
adhesive ("Aron Alpha A" composed of 98 percent
alpha-ethylcyanoacrylate monomer plus 2 percent thickening agent
and inhibitor) was applied directly by a polyethylene stick. After
one minute for polymerization, the distal clamp was released first
and, after confirmation of no occurrence of major bleeding, the
proximal clamp was released. It was microscopically observed that
anastomotic sites were covered smoothly by intimal proliferation
within two weeks, and anastomosis was successfully
accomplished.
Illustrating the present invention in reference to the attached
drawings, FIG. 1 shows the front views of the tubes which are three
typical embodiments of the invention. That is, FIG. 1 (A) shows a
cylindrical tube (1) tapered at both ends and provided two grooves
(11,11) circumferentially on the outer surface. FIG. 1 (B) shows a
T-letter shaped tube (2) tapered at each end and provided three
pairs of protuberances (21,21,21) circumferentially on the outer
surface. FIG. 1 (C) shows a Y-letter shaped tube (3) tapered at
each end and provided three grooves (31,31,31) circumferentially on
the outer surface. The tapered portion is served for making it easy
to insert into vascular lumens. The grooves and the protuberances
are available for prevention of slipping out of vascular ends. If
desired, ring clips may be placed on the groove or protuberance
portion after insertion the tube in blood vessels.
FIG. 2 illustrates the steps for connecting blood vessels according
to the present invention. FIGS. 2 (A) and (B) show respectively two
blood vessels (4,4) to be connected each other at the section
surface (41) and a spindle tube (5) (same as shown in FIG. 1 (A))
provided two grooves (51,51) before the connection. In FIG. 2 (C)
showing the intermediate state for connection, both ends of the
tube (5) are inserted into the lumens of the blood vessels (4,4).
At this stage, an adhesive is applied to the section surface (41).
In FIG. 2 (D) showing perfection of the insertion, two ring clips
(6,6) are placed on the outer surfaces of the blood vessels at the
places corresponding to the grooves of the tube now completely
enclosed in the blood vessels for securing the connecting. In FIG.
2 (E), there is shown the state after accomplishment of the
connection where the tube dissolved and disappeared into blood
flow.
* * * * *