Inflatable balloon catheter

July 24, 1962

F. J. WALLACE

INFLATABLE BALLOON CATHETER

Filed May 3, 1960

3,045,677

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United States Patent Office

3,945,677

Patented July 24, 1962

3,045,677

INFLATABLE BALLOON CATHETER

Frederick J. Wallace, New York, N.Y., assignor to American Cystoscope Makers, Inc., Pelham Manor, N.Y., a corporation of New York

Filed May 3, 1960, Ser. No. 26,619

Claims. (Cl. 128—349)

This invention relates to an inflatable catheter and more particularly to such a catheter which is especially well suited for providing drainage from a body cavity while at the same time providing an improved haemostatic effect.

It has long been sought and considerable effort has been made to improve catheters hitherto in use for draining internal cavities such as the bladder while at the same time suppressing bleeding from adjacent tissue. Catheters having two inflatable balloons have long been known. Such a catheter is positioned in the uretha leading to the bladder with its distal end extending into the bladder. The two balloons are formed on the hollow catheter shaft in close spaced relation so that when inflated they each surround the shaft and through a mutual clamping action engage internal and external surfaces on the opposite sides of the restriction leading to the bladder, thus providing a haemostatic effect on the engaged tissues.

Various measures have hitherto been proposed to improve the haemostatic action of such catheters such as by forming the balloons in overlapping relation or by otherwise interconnecting the adjacent surfaces of the balloons with a view toward restraining them against deformation or movement away from each other when inflated. I have found that an improved catheter is provided in accordance with the present invention while at the same time avoiding the manufacturing difficulties encountered in forming the thin walled balloons in overlapping relation or with their adjacent walls interconnected.

An important feature of the present invention resides in the provision of a catheter construction in which two balloons are formed encircling the catheter shaft and a sleeve is fitted to the shaft which completely surrounds both balloons and extends along the shaft beyond the balloons. The balloons are each free to be inflated or deflated independently of the other and are constrained by the sleeve which is preferably formed of similarly resilient material as the balloons. When the balloons are inflated, they expand under the sleeve and distend the latter to form generally an hour-glass shape due to the confining effect of the sleeve which limits separation of the balloons without introducing expansion irregularities such as would necessarily result from variations in the thickness of the ballon wall caused by connecting or anchoring another member thereto.

It is, therefore, a principal object of this invention to provide a catheter having two inflatable balloons which may be readily manufactured to meet the exacting standards required of surgical or medical equipments and which provides an improved haemostatic effect.

Further objects, advantages and features of the present invention will be apparent from the following description of a preferred embodiment thereof and the accompanying drawing in which

FIGURE 1 is an elevational view, partially broken away for convenience of a catheter constructed in accordance with the present invention;

FIGURE 2 is a cross sectional view on an enlarged scale through the line 2—2 of FIGURE 1;

FIGURE 3 is a view partially in cross section of the distal end portion of the catheter while inflated; and

FIGURE 4 is a sectional view through the line 4—4 of FIGURE 3.

Referring now to the drawing in detail, catheter 10 comprises an elongated generally tubular shaft 11 formed with a central bore 12 open at the proximal end 13 of the shaft. The bore 12 may be closed by a rounded 5 distal tip 14 of the shaft 11; drainage openings 15 formed through the wall of the shaft providing communication between the bore 12 and the cavity which is to be drained or otherwise treated. A pair of impervious, resilient membranes or walls 16 and 17, which form the inflatable 10 balloons, are joined to the shaft 11 so that they are each free to expand independently of each other when inflated. Tubular wall 16 is a generally cylindrical member joined at its opposite ends in airtight relation to the shaft so as to overlie the open distal end 18 of an inflation channel 15 19 formed in the wall of shaft 11. Tubular wall member 17 is similar to wall 16 and is similarly joined with shaft 11 adjacent to the proximal end of the wall 16 so as to overlie the open distal end 20 of a second inflation channel 21 formed in the wall of shaft 11.

A pair of tubular inflation members 22 and 23 are joined to the shaft 11 with their bores in communication respectively with the bores 19 and 21. The proximal ends of the inflation members 22, 23 are each adapted to receive a syringe or other suitable device for 25 inflating the respective balloons 16, 17 with water, air or other suitable inflating fluid.

A tube 25 extends over and engirdles the shaft 11 and the balloons 16, 17 affixed thereto. The opposite end portions 25α and 25b of the tube 25 are preferably ce30 mented as shown or otherwise affixed to the shaft 11 where it extends beyond the mutually remote ends of the balloons 16, 17. If desired the end portions 25α and 25b of tube 25 may be left free and uncemented to the shaft 11; frictional engagement betwen the ends of the tube 25 35 and the shaft 11 when the balloons are inflated serving to provide the required anchorage.

Catheter 10 is conveniently formed of rubber latex as is well known in the art. A suitably shaped mold is dipped into a bath of rubber latex a sufficient number of ⁴⁰ times so as to build up the desired wall thickness in the shaft with the inflation channels formed therein as is well known in the art. When the desired base thickness of the shaft 11 has been attained a separating medium is applied over the two annular portions of the shaft where ⁰ the balloon forming wall members 16 and 17 are to be formed. A sufficient number of additional dips into the rubber latex are then made to increase the wall thickness of the shaft 11 to provide the desired thickness of the walls 16 and 17. As thus formed, it will be noted that each of the walls 16 and 17 is integrally united with the material forming the shaft 11. Manufacture is completed in the conventional way, openings 15 being formed and inflation members 22 and 23 which also may be formed gg of deposited rubber latex, being attached.

The tube 25 which may also be formed from rubber latex has a wall thickness which is preferably less than that of the wall members 16 and 17 and is slipped over the end of the shaft 11. With the tube 25 positioned as shown its ends are preferably sealed to the shaft 11. While the catheter may be satisfactorily used without sealing the ends of tube 25 to shaft 11, sterilization is facilitated and the need for removing and re-attaching the tube is avoided when the tube and shaft are sealed to_6g gether.

The catheter is inserted in the patient in the customary way. When used to drain the bladder and to effect haemostasis adjacent the neck between the bladder and urethra, the catheter is inserted with its distal end 14, openings 15 and at least balloon 16 positioned in the bladder. Balloon 16 is inflated to facilitate locating the catheter with respect to the neck and then both balloons

3,045,677 ³ are inflated so that the expanded tube 25 is approximately centrally positioned with its restriction 25c (FIGURE 3) at the restriction between the bladder and the urethra. The portions of tube 25 on opposite sides of its restriction 25c are firmly urged against the body tissue with substantially equal pressure on both sides of the restriction.

In the preferred embodiment described, each balloon is provided with an independent inflation channel. I may also form the shaft 11 with a single inflation channel which may be used to inflate both balloons. It is also to be noted that, while only two balloons are shown and described, additional balloons adjacent to or spaced a substantial distance from balloons 16 and 17 may be provided. The length of tube 25 may be extended as required or an additional tube similar to tube 25 may be used to enclose the additional balloons.

The terms and expressions which have been employed are used as terms of description and not of limitation, and there is no intention, in the use of such terms and expressions, of excluding any equivalents of the features shown and described or portions thereof, but it is recognized that various modifications are possible within the scope of the invention claimed.