US 3045677 A
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July 24, 1962 F. J. WALLACE INFLATABLE BALLOON CATHETER Filed May 5, 1960 MMNMMM United States Patent OF 3,045,67 7 INFLATABLE BALLON CATHETER Frederick J. Wallace, New York, N.Y., assignor to American Cystoscope Makers, Inc., Pelham Manor, NX., a corporation of New York Filed May 3, 1960, Ser. No. 26,619 4 Claims. v(Cl. 12S-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 lthe 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 eeot on the engaged tissues.
Various measures have hitherto been proposed to irnprove 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 liaernostatic 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 l;
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.
3,045,677 Patented July 24, 1962 ICC 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 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 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 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 inilating the respective balloons 16, 17 with water, air or other suitable inflating fluid.
A tube 25 extends over and engirdles the shaft 1-1 and the balloons 16, 17 affixed there-to. The opposite end portions 25a and 25b of the tube 25 are preferably cemented `as shown or otherwise afiixed to the shaft 11 where it extends beyond the mutually remote ends of the balloons 16, 17. If desired the end portions 25a and 25h 0f tube 25 may be left free and uncemented to the shaft 11; frictional engagement betwen the ends of the tube 25 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 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 tart. 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 the balloon forming wall members 16 and 17 `are to be formed. A suflicient number of additional dips into the rubber latex are then made to increase the wall thickness of the shaft 1.1 to provide the desired Ithickness of the walls 16 and 17. As thus formed, it will be noted that each of lthe walls 16 and 17 is integrally united with the material forming the shaft 11. Manufacture is completed in the conventional way, openings 1S being formed and inflation members 22 and 23 which also may be formed of :deposited rubber latex, being attached.
'Ilhe tube 25 which may also be formed vfrom rubber latex has a W-all thickness which is Ipreferably less than that of the Wall members v16 and 17 and is slipped over the end of the shaft 111. 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 sh-aft 1.1, sterilization is facilitated and the need for removing and re-attaching the tube is Iavoided when the tube and shaft are sealed tofgetfher.
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 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 25e are firmly urged against the body tissue with substantially equal pressure on both sides of the restriction.
ln the preferred embodiment described, each Iballoon 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 yor 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 2S 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.
What is claimed is:
l. An inflatable `balloon catheter, comprising a shaft, a first inflatable balloon member joined to said shaft, a second inflatable balloon member joined to said shaft spaced from said first balloon member, said first and second balloon members each having `a wall thickness substantially less than that of said shaft and each forming with said shaft `a chamber for receiving `an inflating medium, a resilient expansible member frictionally engaging and enclosing said first and second balloon members and positioned with its opposite end portions extending along said shaft and beyond the opposite mutually remote ends of said balloon members, and means on said shaft communicating with said chambers for inflating said balloon members.
2. Inflatable balloon catheter, comprising a tubular shaft having `an axial bore providing communication be- -tween its proximal end and a drainage opening formed 'adjacent to the distal end of said shaft, a first inflatable balloon member joined Ito said shaft and encircling the same adjacent to said drainage opening, a second inflatable ballon member joined to yand encircling said shaft spaced from the end of said first balloon remote from said drainage opening, said first and second balloon members each having a wall thickness less than that of said shaft and each forming with said shaft an annular chamber for receiving an inflating medium, a Iresilient expansible tubular member frictionally engaging and enclosing said first and second balloon members and positioned with one of its end portions extending 'along said shaft beyond the distal end of said first balloon member and with its other end portion extending along said shaft beyond the proximal end of said second balloon member, and means on said shaft communicating with said chambers for inflating said balloon members.
3. An inflatable balloon catheter, comprising a tubular shaft having `an axial bore providing communication be- `tween its proximal end and a drainage opening formed adjacent to its distal end, a first tubular inflatable balloon member integrally united along its opposite ends with the outer surface of said shaft yand encircling the same adjacent to said drainage opening, a second tubular inllatable balloon member integrally united along its opposite ends with the surface of said shaft and encircling the same spaced from the proximal end of said first balloon member, said first and second `balloon members respectively lforming first and second annular inflation chambers with said shaft, a resilient expansible tubular member frictionally engaging said first and second balloon members with its distal end portion extending `along said shaft beyond the distal end of said first balloon member toward said drainage opening, the proximal end portion of said tubular member extending along said shaft beyond the proximal end of said second balloon member, said distal and proximal end portions of said tubular member being secured directly to the respective under1ying portions of said shaft, and means for inflating said balloon members including first and second inflation channels communicating respectively with said first and second chambers.
4. An inflatable balloon catheter, comprising a shaft, a first inflatable balloon member joined to said shaft, a second inflatable balloon member joined to said shaft spaced from said first balloon member, said first and second balloon members each forming with said shaft a chamber for receiving an inflating medium, a resilient expansible member enclosing said first and second balloon members `and positioned with its opposite end portions extending along said shaft and beyond the opposite mutually remote ends of said balloon members, means on said shaft communicating with said chambers for inflating said balloon mem-bers, and said expansible member unadhesively engaging said balloon members and, when said balloon members are inflated, forming substantially an hounglass shape constraining said balloon members against separation one from the other.
References Cited in the file of this patent UNITED STATES PATENTS 1,690,995 Pratt Nov. 6, 1928 2,849,002 Oddo Aug. 26, 1958 FOREIGN PATENTS 693,224 Great Britain June 24, 1953