US 3435824 A
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A ril 1, 1969 H. GAMPONIA 3,435,324
SURGICAL APPARATUS AND RELATED PROCESS Filed Oct. 27, 1966 Sheet 4 of 2 INVYUVTOR HERMHHO GAMPONM ATTORNEYS April 1969 H. GAMPONIA 3,435,824
SURGICAL APPARATUS AND RELATED PROCESS Filed Oct. 27, 1966 Sheet 2 of 2 HERMI NIO GAMPONIA ATTORNEYS United States Patent 3 435 824 SURGICAL APPARATUS AND RELATED PROCESS Herminio Gamponia, Flushing, N.Y. (668 Stratton St., Logan, W. Va. 25601) Filed Oct. 27, 1966, Ser. No. 590,079 Int. Cl. A61b 17/00, 19/00 U.S. Cl. 128-334 9 Claims This invention relates to surgical apparatus and techniques and more particularly to devices and processes useful in connection with heart surgery and types of surgery in which a portion of a blood circulatory system has to be by-passed.
If, by way of example, there is an aneurysm in an arterial vessel, surgical processes are known by means of which remedial measures will be effected. Such processes, however, require that the portion of the arterial vessel to be operated upon be temporarily by-passed so that the flow of blood can continue while the diseased situation is being corrected.
In accordance with known techniques a tube may be employed to by-pass the diseased section, the extremities of the tube being inserted through slits made in the vessels into the interior of the same thus constituting a shunt through which the blood flows. It is necessary, however, that the tube extremities be retained in position in the blood vessel so that the tube does not become detached during the operation. To this end it is known to retain the tube extremities in position by the use of tying sutures or surgical thread or the like around the vessels at positions whereat said extremities are internally located. This procedure is, however, time consuming and in addition may possibly traumatize the blood vessel due to a possibly overtight tying of the cord.
It is an object of the invention to provide techniques and structures for avoiding the above problem and particularly for maintaining the ends of a by-pass tube in position Within a circulatory system while at the same time avoiding the need for the external application of a cord or the like.
In achieving the above and other of its objectives, the invention involves the use of a tube, the extremities of which are encircled by an inflatable bladder or collar such that when the extremities are inserted into a vessel such bladder can be inflated to retain the extremities in position within the circulatory system.
The inflatable means will preferably be an integral part of the tube and a duct means may be provided which is also preferably integral with the tube and which leads to a branch by means of which a pressure medium can be introduced into the aforesaid bladder.
The pressure medium is preferably a liquid such as Water and the source of the same may take the form of a detachable syringe. The syringe will be insertable into the aforesaid branch which preferably contains a one-way releasable valve which will retain the water in the bladder under pressure once the water has been inserted.
Because the tube structure of the invention is especially intended for use in connection with blood vessels or the like, such tube, as will be shown, will preferably be of a nature which is atraumatic to blood cells. In addition, the tube will preferably be of a transparent material so that it is possible to determine visually when the tube is performing its shunting function. Other requirements for the tube and related structures will be indicated in greater detail hereinafter.
According to the surgical technique of using the aforesaid tubular structure, the initial step involves partially cutting through the circulatory or vessel system at positions located at opposite ends of the diseased section. Thereafter the extremities of the aforesaid tube are inserted into the thusly resulting cuts, the tube being so ice selected as to have a diameter closely matching the inner diameter of the vessel or vessels adjacent the cuts. The bladder in each extremity is thereafter inflated with a pressure medium to an extent such that the extremities are retained in the system but with a pressure less than that which would cause the system to rupture. Further details in respect of this process will be discussed hereinafter.
As a feature of the invention it is possible to construct a tubular system with a multiplicity of branches, some of which, or all of which, are provided with inflatable bladders or portions capable of retaining these extremities in position in a circulatory system.
The invention Will be more clearly understood from the following detailed description of some preferred embodiments thereof as illustrated in the accompanying drawing, in which:
FIGURE 1 diagrammatically illustrates a portion of a circulatory system in which a diseased portion thereof is shunted by a tubular shunt provided in accordance with the invention;
FIGURE 2 is an enlarged view of one of the extremities of the tubular shunt taken along line II-1T of FIG. 1; and
FIGURE 3 is a diagrammatic representation of a tubular system illustrative of a multi-branch system.
In FIG. 1 is illustrated diagrammatically a heart 10 having a right auricle 12, a left auricle 14, a right ventricle 16 and a left ventricle 18. The pulmonary artery 20 extends from the right ventricle to the exterior of the heart and branches into the right pulmonary artery 22 and left pulmonary artery 24. The aorta 26 extends from the left ventricle and branching therefrom is the right innominate artery 28 which branches into the right subclaviclavian artery 30 and the right common carotid artery 32. The left common carotid artery 34 branches from the aorta downstream of the aforesaid system as does the left subclaviclavian artery 36. The inferior vena cava 38 and the superior vena cava 40 empties into the right auricle 12.
It will now be assumed that the section S of the aorta 26 is diseased such as, for example, by an aneurysm requiring the application of surgical technique during which the section S must be temporarily by-passed. By means of one known technique, incision is made into the aorta at the beginning of the operation and the extremities of a suitable tubular shunt will be inserted into the aorta through these slits or incisions and maintained in position by means of surgical thread or the like which is wrapped around the aorta and the tubular extremities accommodated therein to lock the latter in position. It will be easily understood, however, that such an operation is time consuming and also unwieldy and furthermore may subject the aorta to a trauma due to the cutting or pinching action of the surgical cord. The invention avoids such difficulties by providing a more sophisticated locking arrangement involving inflatable balloons, bladders or collars as will next be explained with reference to both FIGS. 1 and 2.
In FIGS. 1 and 2 appears a tubular shunt 42 constructed preferably of a transparent flexible material such as a plastic or a silicon rubber. The outer diameter of such tube is preferably selected as to provide for a close fit within the aorta at those zones of the aorta whereat the slits for insertion are made. The outer diameter should be preferably such that a free insertion of the tubular extremities into the aorta is possible without stretching the aorta and, more particularly, the outer diameter of the tube will preferably be about 87-98% of the inner diameter of the aorta in the zones of insertion. The inner surface of the tubular shunt 42 is preferably siliconized to minimize trauma on the blood cells which will pass through the shunt.
The extremities of the tubular shunt 42 will be hereinafter identified as end portions 44 and 46, the latter being shown in enlarged scale in FIG. 2. The wall thickness of the tubular shunt is of a continuous thickness T throughout with an exception which will be hereinafter explained and the bore 48 is also preferably of a continuous diameter extending without change axially throughout the entire tubular shunt. The thickness T may preferably be in the order of 12 millimeters, although this may vary depending on the material, provided that the functions to be hereinafter enumerated are accomplished. The end profile indicated at 50 of the tubular wall is preferably rounded in order to avoid injury to the blood vessel during insertion.
The wall thickness of the tube is reduced at 52 to define with an inflatable bladder 54 encircling the end portion of the tube an internal chamber 56. Said chamber is connected with an internal duct 58- extending axially through the wall of the tubular shunt to a branch 60 through which a pressure medium can be introduced. At the outermost extremity of the branch 60 is provided a valve 62 of conventional type which is a one-way valve which is releasable as will be explained. A similar branch 64 is provided in respect of extremity 44 and if the system is a multibranch system, as will hereinafter be illustrated, additional inlets will also be provided.
The pressure medium employed in accordance with the invention is preferably sterile water or some other incompressible fluid. The pressure medium may be stored, for example, in syringes 66 and 68 separately, although a single syringe can serve the purpose of providing the pressure medium for all bladders. Similarly frangible capsules maybe substituted for the syringes to provide acompletely self-contained system.
When the ends of the tubular shunt are duly inserted in slits at opposite extremities of diseased section S, syringes 66 and 68 are individually operated to force water by the respective valves into inlets 60 and 64. Regarding inlet branch 60, by way of example, the water passes therefrom and via internal duct 58 into chamber 56 which, as aforesaid, is an annular chamber completely encircling end portion 46. This in turn causes an expansion of membrane 54 which bulges outwardly carrying the expandable blood vessel wall therewith thereby to constitute an enlargement which will prevent ready withdrawal of the shunt extremity from the vessel. Expulsion of the pressure fluid is prevented by means of the aforesaid valves which, however, may be opened to release the pressure medium after the surgical process on diseased section S has been completed.
The duct means 58 noted above has been shown as being accommodated internally within the wall of the tubular shunt. It would also be possible to run a separate tube to the chamber 56, for example, by means of a separate but substantially smaller tube internally accommodated within the shunt. The extent of the inflatable bladder structure noted above is, for example, up to /2 from the extremities of the shunt and the inlet branches 60 and 64 are preferably, for example, a minimum of about 1 from the ends of the tubular shunt and even more to facilitate manipulating the syringes. To this end the inlet branches 60 and 64 preferably extend a minimum of about 1 from the shunt.
The flexible material in the end portions and particularly in the area adjacent the inflatable bladder is of a thickness and strength which will be resistant to collapsing when the inflatable bladder is inflated. This will normally present no problem since the wall thickness at such zones will be decreased only very slightly to accommodate the membrane 54 which will be relatively thin in order to permit ready inflation.
The bladder at the end portions of the tubular shunt will be inflated to an extent that the end portions are effectively retained in the circulatory system but with a pressure of less than that which would cause the system to rupture. For example, an inflation of the bladder with water under a pressure corresponding to about 2040 millimeters of mercury above atmospheric pressure is suflicient to accomplish the aforenoted purposes. In addition, if the end portions are inserted into the blood vessel a minimum of about this will be found satisfactory to permit the above-noted tubular shunt to operate effectively.
When the operation on the diseased section is completed there is no necessity of untying the surgical cord of the prior art techniques. Instead it is only necessary to release the valves of the inlet branches. This will enable the bladder to deflate and the end portions of the shunt may be readily removed without interference. It is preferable that the upstream end of the shunt be removed first to avoid the unnecessary loss of blood.
FIGURE 3 illustrates a multi-branch tubular shunt for insertion at three locations in a circulatory system. Said shunt consists of a main tube 70 and two smaller branches 72 and 74. These tubular sections are respectively provided with inflatable bladders 76, 78 and and inlet branches 82, 84 and 86.
To give dimensional illustration of the structure of FIG. 3, the entire structure may have an overall length of about 2 feet. Bladder 76 may extend along tube 70 for about two centimeters whereas bladders 78 and 80 extend from their respective ends for about one centimeter. Inlet branches 82, 84 and 86 are preferably tapered from a dimension to readily accommodate a syringe to a smaller diameter compatible with the size of the duct leading along the shunt wall to the aforesaid flexible bladders.
The structure of FIG. 3 is illustrative only of the nuerous variations and functions which the invention may provide inasmuch as tubular shunts have been designed inclusive of as many as seven end portions adapted for insertion at various zones in a circulatory system.
There will now be obvious to those skilled in the art many modifications and wariations of the structures and techniques set forth hereinabove. Such modifications and variations will not, however, depart from the scope of the invention if defined by the following claims.
What is claimed is:
1. Surgical apparatus comprising a tube including at least two end portions adapted for insertion into spaced locations in a fluid carrying system, said tube and end portions being provided with a continuous axially disposed bore extending completely therethrough, and inflatable means connected to and encircling each of said end portions for retaining the end portions in said system after insertion into the same.
2. Apparatus as claimed in claim 1 comprising a duct means at least partly integral with said tube and coupled to said inflatable means, said duct means extending from the inflatable means to positions remote from the end portions so that an inflating medium can be transmitted to said inflatable means from positions external to the system.
3. Apparatus as claimed in claim 2 comprising a source of liquid detachably connectable with said duct means to supply liquid to said inflatable means to inflate the latter.
4. Apparatus as claimed in claim 3 for use with blood vessels wherein the tube is of a material which is atraumatic to blood cells and wherein the tube has a well the end profile of which is rounded.
5. Apparatus as claimed in claim 4 wherein said tube is of transparent material.
6. Apparatus as claimed in claim 4 wherein said tube is of a flexible material having a thickness which is strong enough to resist collapsing when said inflatable means is inflated, said inflatable means including an annular ring of expandable material encircling each related end portion and extending along the tube for up to about one-half inch from the respective ends thereof, said duct means including branches branching from the tube at approximately one inch from the respective ends thereof, said branches including one-way releasable valves for enabling the insertion and retention of liquid for inflating said inflatable means, said branches further extending a minimum of about one inch from said tube.
7. A surgical process for by-passing a section of a blood vessel system, said process comprising partially cutting through the vessel system at a position at least one end of said section, inserting into the thusly resulting cut the extremity of a tube having a diameter closely matching the inner diameter of the system adjacent said cut and which tube has an inflatable bladder encircling said extremity, and inflating said bladder with a pressure medium to an extent that said extremity is retained in the system but with a pressure of less than that which would cause the system to rupture.
8. A process as claimed in claim 7 wherein the tube 6 extremity is inserted into said system a minimum of about three-quarters of an inch.
9. A process as claimed in claim 8 wherein the bladder is inflated with water under a pressure corresponding to about 20-40 millimeters of mercury above atmospheric.
References Cited UNITED STATES PATENTS L. W. TRAPP, Primary Examiner.
US. Cl. 128-348