US 3568679 A
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United States Patent 1,696,763 12/1928 Hare Inventor James R. Reif Midland, Mich. Appl. No. 774,662 Filed Nov. 12, 1968 Patented Mar. 9, 1971 Assignee Dow Corning Corporation Midland, Mich.
CATHETER PLACEMENT UNIT 2 Claims, 10 Drawing Figs.
US. Cl. 128/349, 128/133 Int. Cl A6lm 25/02 Field of Search 128/348- References Cited UNITED STATES PATENTS Primary Examiner-Dalton L. Truluck Attorneys-Robert F. Fleming, .lr., Laurence R. Hobey, Harry D. Dingman and Howard W. Hermann ABSTRACT: A unit for retaining a catheter in a desired place within a bod y is disclosed. A thin disk of flexible material, preferably silicone rubber, is adhesively secured to any desired external surface of a body. If the surface has already been punctured, a desirable catheter is then introduced into the body through an aperture in the disk, otherwise a tract): can be used to puncture the surface and introduce the catheter into the body. When the catheter has been placed in the desired position, it is then locked in place by a locking device affixed to the disk.
PATENTED MAR 9|97l 3,568,679
SHEET 2 BF 3 F/g: a
INVENTOR JAMES R. REIF BY/%m..,
A TTORIVE Y PATENTEDHAR 9197: 3568.679
sum 3 OF 3 INVENTOR JAMES R. RE IF ATTORNEY CATHETER PLACEMENT UNIT Background of the Invention The present invention relates to the field of surgical appliances, and more particularly, to catheters and their proper placement.
(Iatheters of many sizes, shapes and designs have long been used in the bodies of humans and other animals to permit injection or withdrawal of fluids. A problem occurs with catheters being so used in that either they can slip out of the body thereby stopping the-desired injection or draining, or they can be drawn into the body thereby causing damage to body tissue and frequently necessitating surgery for their removal.
Accordingly, many devices for a proper placement or retention of a catheter have been developed. Some of these devices include balloons attached to the distal end of a catheter, wings or barbs, hooks, tape, sr straps or belts, and even safety-pins.
For various reasons, some persons are not able to urinate in a natural or normal manner. The usual method of enabling such persons to void their bladders is by use of a Foley cathetera commonly used name for a balloon or bulb retention catheter. Generally, the Foley catheter is inserted through the urethra of the patient into the bladder, and the balloon is then inflated to hold the catheter in place.
It is widely reported in the medical journals, that such use of a Foley catheter causes much discomfort for the patient. If the Foley catheter is needed for any extended period of time, serious tissue irritation in both the bladder and urethra can occur, and the catheter frequently becomes occluded by such body residues as clotted blood, lymph and bladder stones. Frequent recatherization therefore is required, adding more discomfort for the patient.
Further, studies have shown that the Foley catheter introduces infection. Indeed, one such study found that 98 percent of the patients who use a Foley catheter for four or more days of constant urinary drainage have bacteriuria of a significant amount. This fact is particularly important for the female patient following vaginal repair, where thepatients hygiene is extremely important.
Still another disadvantage of the Foley catheter is that the patient cannot use normal urinating procedure while the catheter is in place in the urethra. Thus, due to lack of use, nearly 100 percent of all patients cannot naturally urinate after the first removal of the catheter. Thus, recatherization is necessary, and in nearly 50 percent of all cases, recatherization takes place a minimum of three times before the patient can urinate naturally.
Accordingly, doctors and medical researchers have turned to other methods of maintaining bladder decompression. Recently, several doctors have developed a suprapubic cystotomy system. In one study at the University of Nebraska, suprapubic cystotomies using polyethylene tubing for continuous postoperative urinary drainage were performed in 37 patients having vaginal plastic procedures. The patients with cystotomies required three days less continuous urinary drainage and three days less hospitalization than a control group of patients managed with indwelling Foley catheters. The incidence of bacteriuria among these patients was reduced to 19 percent.
Briefly stated, suprapubic cystotomies for urinary drainage are performed by locating the patients bladder from the exterior, puncturing the skin, flesh and bladder with a needle and introducing a catheter into the bladder through that puncture. A suitable adapter is then placed in the a catheter and a tube attached thereto having its distal end placed in a drainage bag for continual urinary collection.
The patient is encouraged to drink fluids and is given sitz baths on the first postoperative day. The patient is encouraged to void while in the sitz bath, thus enabling the patient to urinate naturally, or at least attempt to do so, while the catheter still is in place in the bladder. After voiding 50-100 ml. on two or three occasions, the catheter is removed, and no further catherizations are required.
The suprapubic cystotomy requires a better catheter placement or locking device than has been available prior to the present invention. Some doctors have merely sutured the cystotomy catheter to the skin of the patient, while other have taped the catheter to the skin. Consequently, some patients have had the catheter fall out of the bladder, while other patients have passed the catheter through the urethra while voiding, because the catheter was not adequately locked in place. When too much of the catheter works its way into the bladder, tissue damage can occur. If the catheter works free of the tape and adapter and is completely drawn into the bladder but not passed through the urethra, surgery is required to remove it. Additionally, skin irritation can be caused by the tape used to secure the catheter.
Summary of the Invention The primary object of the present invention, therefore, is to provide an improved catheter placement unit which will be free from the aforementioned and other disadvantages of prior devices of this type.
More particularly, it is an object of the present invention to provide a catheter placement unit capable of retaining a catheter at a desired position in a body by locking the catheter into a locking means on the external surface of the body.
Another object is to provide a catheter placement unit which is capable of preventing body fluids from being deposited on the skin surrounding the puncture or opening made in the skin and flesh prior to the insertion of the catheter.
Still another object is to provide a catheter placement unit capable of protecting the puncture wound from external infection.
In accordance with these and other objects, there is provided by the present invention a thin disc which is adhesively secured to a body at the spot where a catheter is desired to be inserted. A trocar can then be used to introduce the catheter to some desired location in the body through the disc. The trocar is then removed from the body, and catheter is locked securely into the locking means affixed to the disc. The locking means affixed to the disc consists of a block of substantially semirigid material which has an aperture or passageway through it in a direction substantially parallel to the portion of the disc to which the block of material is affixed. A slit extends radially from the aperture, along its full length, through an external edge of the block. The catheter is locked in place by forcing it through the slit until it reaches the aperture, whereupon the semirigid material closed around the catheter, locking it securely in place.
Thus, the catheter is securely locked into place by the locking means affixed to the disc, and the body is protected by the disc from having body fluids deposited on the skin surrounding the puncture or opening made in the skin and flesh prior to the insertion of the catheter. Likewise, the puncture wound is protected by the disc from external infection or irritation.
Brief Description of the Drawings Other objects and many more attendant advantages will become obvious to those skilled in the art by reading the following detailed description in connection with the accompanying drawings wherein:
FIG. 1 is a view in elevation of a trocar usable in one embodiment of the present invention showing the head thereof in cross section;
FIG. 2 is a view in elevation of a catheter usable in one embodiment of the present invention;
FIG. 3 is a top plan view of the disc of the present invention showing one embodiment of the locking means affixed thereto;
FIG. 4 is a view in elevation of the disc of FIG. 3;
FIG. 5 is a top plan view of the disc of the present invention showing another embodiment of the locking means affixed thereto; I
FIG. 6 is a view in elevation of the disc of FIG. 5;
FIG. 7 is a top plan view of the disc of the present invention showing another embodiment of the locking means affixed thereto;
FIG. 8 is a view in elevation of the disc of FIG. 7;
FIG. 9 is a view partially in cross section showing the catheter placement unit of the present invention being inserted into the bladder of a human; and
FIG. 10 is a view partially in cross section showing a catheter locked in a desired position within a human bladder by an embodiment of the placement unit of the present invention.
Description of the Preferred Embodiments Referring now to the drawings, wherein like reference numerals designate like or corresponding parts throughout the figures thereof, there is shown in FIG. I a trocar, shown generally as 11, having a hollow shaft 13 with a pointed tip 15 suitable for puncturing the skin and flesh of humans and other animals. The trocar preferred by applicant has a head tapered inwardly from the top and having a groove 17 in which a catheter can be accommodated. The trocar does not have to be hollow, but it must be capable of introducing a desired catheter into a body.
A catheter 21 made of a flexible material and having small holes 23 at one end is shown in FIG. 2. The holes enhance the injection or withdrawal of fluids from a body, but a catheter without such holes in the sidewalls may also be used. For most applications, a silicone rubber catheter has been found to produce the best results in terms of patient comfort and continue operability. That is, a silicone rubber catheter has been found to plug up less often than catheters of other materials and to cause less tissue irritation than other catheters. When a hollow trocar is used, the catheter 21 must have an outer diameter less than the inner diameter of the shaft 13 so that the catheter may be introduced through the shaft 13 into the body. However, a rodlike trocar having a catheter ensleeved about it can also be used as the means of introducing the catheter into the body.
Further, while a particular catheter 21 has been shown, it is to be understood that any type or design of catheter desired may be used within the spirit of the present invention. Likewise, if a wound or opening already exists in the body, the catheter obviously can be inserted therein without the use of a trocar.
In FIG. 3, there is shown a thin, flexible disc 25 having an aperture 27 therethrough and a block of a substantially semirigid material 29 affixed thereto. The disc is flexible so that it can readily conform to the surface of the body on which it will be adhesively secured. Further, the disc is preferably made from a silicone rubber, which in addition to being nonirritating to the skin, can be made clear to allow for inspection of the wound site. Although the word disc is generally understood to mean a circular object, within the scope of this invention, the word disc" will also be used to mean ovals, squares, rectangles and other polygons.
The function of the aperture 27 is to receive the trocar I1 and the catheter 21 when they are introduced into the body. Although the aperture 27 is preferred, it is obvious that a disc 25 not having such an aperture 27 can be used if the disc is made from material which can be punctured by the trocar 11. Preferably, the disc 25 is made from a silicone rubber, since that material allows the covered skin to breathe by allowing vapors to diffuse through it.
The block of substantially semirigid material 29 is the locking means by which a catheter 21 can be locked into a desired position. An aperture or passageway 31 passes through the block 29 in a plane substantially horizontal to the surface of the disc 25 to which the block is affixed. This aperture 31 must have a diameter equal to, or slightly smaller than, the outer diameter of the catheter 21, if the catheter 21 is to be locked securely therein.
As can be seen in FIG. 4, there is a slit 33 extending substantially radially from the aperture through an external wall of the block 29. The slit 33 runs the full length of the aperture 31 and can extend in any direction as long as it will emerge from the block at a place other than where the block is affixed to the disc 25. When it is desired to lock the catheter in place, the block of semirigid material 29 is forced open along the slit 33, and the appropriate portion of the catheter 21 is force through the slit 33 until it reaches the aperture 31. The slit 33 is then allowed to close, thereby securely locking the catheter 21 in place.
The block of semirigid material 29 can be adhesively secured to the disc 25 by a suitable adhesive, or the entire disc 25 and block 29 can be molded as one piece. Obviously, the aperture 31 can be drilled through the block 29 and the slit 33 made therein either before or after it has been affixed to the disc. The semirigid material 29 must be rigid enough to prevent the catheter from being easily pulled out of the aperture 31, but must have some flexibility so that the slit 33 can be forced open to allow the catheter to enter the aperture 31.
Variations of the locking means 29 as shown in FIGS. 58. The aperture 27 through the disc also passes through the block of semirigid material 29 in each of these variations. Also, the locking means or block 29 extends along an entire diameter in each of the embodiments shown in FIGS. 5 and 7, thus allowing the catheter 21 to be locked in either of two directions when location of attached equipment or other considerations, such as skin irritation, require. Further, each end of these blocks tapers inwardly at a 45 angle from the surface of the disc 25.
The slit 33 extends substantially radially from the aperture or passageway 31 in a direction substantially perpendicular to the disc 25 in the embodiment shown in FIG. 5 and FIG. 6. The slit 33 in the embodiment shown in FIGS. 7 and 8 extends from the aperture or passageway 31 in a direction substantially horizontal to the disc 25. The locking means 29 shown in FIG. 7 has a portion cut away in the area 35 surrounding the aperture 27 through the disc. Thus, the block 29 defines a cleft or valley around the aperture 27, which cleft facilitates handling ofthe catheter 21 while it is being locked into place.
One use ofa specific embodiment of the catheter placement unit of the present invention is in a suprapubic cystotomy as illustrated in FIGS. 9 and 10. The bladder 41 of a human, shown partially cut away, is distended by the insertion of 300- 400 cc. of a saline solution therein through the urethra, using a urethral catheter, or the like. The bladder 41 may then readily be located by probing the external surface of the body 43.
When the proper site for puncturing the body 43 has been located, a sterile medical grade silicone adhesive is applied to both the skin of the body 43 at that site and the appropriate surface of the disc 25. Preferably, the adhesive used is Medical Adhesive-B sold by the Dow Corning Corporation, Midland, Michigan, and it may be applied by either spraying or swabbing of the desired amount.
The disc 25, made from a silicone rubber, having a diameter of three inches, a thickness of .035 inches and an aperture 27 with a diameter of .078 inches through its center is then applied to the skin 43. The aperture 31 through the block 29 has a diameter of .093 inches, and the slit 33 has a width of .062 inches.
A trocar 11 made from a stainless steel tube having an outer diameter of .134 inches and an inner diameter of .l 14 inches and a length of 3V2inches is then advanced through the aperture 27 in the disc 25 and into the bladder 41.. A catheter 27., made from a silicone rubber, is threaded through the trocar shaft and into the bladder 41, as shown in FIG. 9. The catheter 21 has a length of 12 inches, an outer diameter of .l 10 inches and an inner diameter of .050 inches.
Then the trocar 11 is removed from the bladder 41 and the disc 25, and the catheter 21 is forced through the slit 33 until it reaches the aperture 31 in the semirigid block 29. Thus, as can be see in FIG. ll), the catheter 21 is locked in a desired place within the bladder .41 by the locking means 29 affixed to the disc 25. Further, the skin of the body 43 has been protected from body fluids excreted from the body prior to the is insertion of the catheter 21 into the puncture wound, and the puncture wound continues to be protected by the disc from external infection or irritation.
Obviously, the catheter placement unit as described herein has uses other than in the suprapubic cystotomy system described above. Some of these other uses include relief of pneumothorax, applying artificial pneuomothorax, drainage of fluid accumulations, caudal anesthesia, pleural punctures and feeding tubes.
Having now described the invention in specific detail and exemplified the manner in which it may be carried into practice, it will be readily apparent to those skilled in the art that innumerable variations, applications, modifications and extensions of the basic principles involved may be made without departing from its spirit or scope.
1. In a catheter placement unit wherein a catheter is to be inserted into an opening into the body of a patient, transversely through an aperture in a flexible disc adapted to be placed over said opening for preventing infection in said opening and the deposition of body fluids from said opening onto the body of said patient, said disc having a first surface adapted to be adhesively adhered to said body of said patient and a second surface having means whereby said catheter is locked in a desired position, the improvement in said means for locking said catheter which comprises:
a block of substantially semirigid material affixed to said second surface of said disc and substantially coextensive with an entire diameter of said disc, said block having first and second portions separated by said aperture through said disc and defining a cleft around said aperture, said first and second portions having a passageway therethrough substantially parallel to the portion of said second surface to which said block is attached, which passageway is substantially equal in diameter to the outer diameter of said catheter, said first and second portions further having a slit narrower than the diameter of said passageway extending substantially radially away from said passageway in a direction substantially parallel to the portion of said disc to which said block is attached and through an external edge of said block along the full length of said passageway.
2. The catheter placement unit as defined in claim l,
wherein said block and said disc are made from a silicone rubber.