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Urinary retention catheter    
United States Patent4148319   
Link to this pagehttp://www.wikipatents.com/4148319.html
Inventor(s)Kasper; Richard F. (104 Sentry Hill Rd., Monroe, CT 06468); Carvalko; Joseph R. (R.D. 1 Redwood Dr., Bethel, CT 06801)
AbstractDisclosed is an improved drainage catheter for insertion into and retention in the bladder of the human body, and a novel stylet for use in inserting the catheter through the urethra and into the bladder. The catheter is formed of an elongate flexible cannula having a free and unobstructed open end adapted to be inserted into the bladder to permit drainage of waste material from the bladder and to facilitate the insertion of diagnostic instrumentation into the bladder. The end of the catheter in the bladder can expand to widen the opening and cause the open end to lie lower in the bladder. The stylet is an elongate flexible member adapted to be inserted into the cannula prior to the cannula being inserted into the urethra. The cannula and the stylet have cooperating stop means to prevent the stylet from passing through the cannula beyond a predetermined point so that the stylet can be used to push the cannula through the urethra and insert the open end into the bladder. The stylet has a rounded top which protrudes beyond the open end of the cannula to provide a guide for the cannula in passing through the urethra so as to prevent trauma thereto, the tip being removable so that a cleaning brush element can be attached to the stylet. The cooperating stop means can be arranged such that the cannula will deflect at the stop means on the cannula so that the stylet moves freely to provide an indication that the catheter is properly located and secured within the bladder.
   














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Patent Text Patent PDF Print Page Summary File History
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Drawing from US Patent 4148319
Urinary retention catheter - US Patent 4148319 Drawing
Urinary retention catheter
Inventor     Kasper; Richard F. (104 Sentry Hill Rd., Monroe, CT 06468); Carvalko; Joseph R. (R.D. 1 Redwood Dr., Bethel, CT 06801)
Owner/Assignee    
Patent assignment
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Publication Date     April 10, 1979
Application Number     05/755,259
PAIR File History     Application Data   Transaction History
Image File Wrapper   Patent Term   Fees
Litigation
Filing Date     December 29, 1976
US Classification     604/102.02 604/99.02 604/915 604/921
Int'l Classification     A61M 025/00
Examiner     Truluck; Dalton L.
Assistant Examiner    
Attorney/Law Firm     Wittstein; Martin D.
Address
Parent Case    
Priority Data    
USPTO Field of Search     128/348 128/349 128/350 128/351 128/240 128/241 128/246 128/341 128/343 128/2 M 128/DIG. 9
Patent Tags     urinary retention catheter
   
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What is claimed is:

1. A combined inserting and cleaning stylet for use with a retention drainage catheter adapted to be inserted into and retained in the bladder for the continuous drainage of waste material therefrom, the catheter being an elongate flexible cannula having an open and unobstructed distal end to communicate the interior of the bladder with a drainage lumen extending through the cannula from the distal end thereof to the exterior of the urethra, the cannula also having means on an inner wall surface of the drainage lumen adjacent the distal end defining a portion of the drainage lumen of different diameter than the rest of the drainage lumen thereby forming an abutment for the stylet, said stylet comprising:

A. an elongate flexible body member of substantially uniform diameter throughout a major portion of its length,

B. means adjacent one end of said body member defining a portion thereof of different diameter than the rest of the body member and defining an abutment means adapted to engage with the abutment means disposed in the cannula when said stylet is inserted therein,

C. a tapered tip element defining a minor portion of the length of said body member, said tip element having a relatively smooth rounded end,

D. means removably connecting said tip element to the other portion of said body member, and

E. a brush element adapted to be connected to said other portion of said body member after said tip element is removed therefrom,

whereby said stylet is used to insert the catheter by cooperating engagement between said abutment means on said stylet and the abutment means in the cannula, and thereafter is used to clean the cannula by removing said tip element from said other portion of said body member and thereafter connecting said brush element thereto.

2. A stylet as set forth in claim 1 wherein said body member includes a drainage passageway extending throughout the length thereof through which waste material can flow thereby providing an indication of when said tapered tip portion of said stylet has entered the bladder.

3. A retention drainage catheter adapted to be inserted into and retained in the bladder for the continuous drainage of waste material therefrom, and a stylet for inserting the retention drainage catheter through the urethra and into the bladder, said catheter and stylet comprising in combination:

A. an elongate flexible cannula formed of a flexible and pliant material having both distal and proximal ends, the length of said cannula being such that said distal end is disposed within the bladder and the proximal end is disposed exteriorily of the urethra, said cannula having

1. a drainage lumen extending from said distal end substantially to said proximal end,

2. means formed on the inner tubular wall of said drainage lumen defining an abutment means adjacent said distal end of said cannula, and

3. expandable means connected to said cannula adjacent said distal end thereof for retaining said distal end within the bladder after passing through the urethra,

4. said distal end of said cannula defining an unobstructed opening the cross-sectional area of which is substantially equal to the cross-sectional area of said drainage lumen and which lies in a plane substantially perpendicular to the longitudinal axis of said drainage lumen whereby waste material in the bladder flows directly into said drainage lumen at said distal end of said cannula and instrumentation is introduced into the bladder through said drainage lumen, and

B. an elongate flexible stylet adapted to be inserted through said drainage lumen, said stylet being longer than said cannula and having

1. at least a major portion of its length of s substantially uniform diameter which will pass through said drainage lumen,

2. means formed adjacent one end of the stylet defining an abutment means for engagement with said abutment means in said drainage lumen, and

3. a tip portion having a smooth rounded end normally projecting beyond said the distal end of said cannula

whereby said catheter is inserted through the urethra by pushing said catheter therethrough by engagement of the abutment means on said cannula and said stylet until said expandable means enters the bladder to retain said cannula in place, after which said stylet is withdrawn from said cannula.

4. The combination as set forth in claim 3 wherein said stylet includes a longitudinal drainage passageway extending therethrough from said tip portion exteriorily of the urethra through which waste material flows when said tip portion enters the bladder to provide an indication that the distal end of the stylet has entered the bladder and the relative location of the distal end of the cannula.

5. The combination as set forth in claim 3 wherein

A. said means defining said abutment means on said cannula comprises an annular boss projecting radially inwardly of said drainage lumen, and

B. said means defining said abutment means on said stylet comprises a radial boss projecting outwardly from said stylet,

both said bosses having cooperating abutment surfaces which engage when said stylet is inserted into said cannula.

6. The combination as set forth in claim 5 wherein said cannula is tapered adjacent said distal end thereof to form a gradually widening portion from said distal end to facilitate passage of said cannula through the urethra, and wherein said annular boss on said cannula is located adjacent the widest point of said gradually widening portion so that only said gradually widening portion of said cannula is pushed ahead of said abutment means during insertion of the catheter through the urethra.

7. The combination as set forth in claim 3 wherein

A. said means defining said abutment means on said cannula comprises an annular recess formed in said cannula and projecting radially outwardly from said drainage lumen, and

B. said means defining said abutment means on said stylet comprises a radial projection extending outwardly from the surface of said stylet,

both said recess and said projection having forwardly slanting barb-like cooperating abutment surfaces which engage when said stylet is inserted into said cannula.

8. The combination as set forth in claim 7 wherein said cannula is tapered adjacent said distal end thereof to form a gradually widening portion from said distal end, and said recess on said cannula is located adjacent the widest point of said gradually widening portion so that only said gradually widening portion of said cannula is pushed ahead of said abutment means during insertion of the catheter through the urethra.

9. A retention drainage catheter adapted to be inserted into and retained in the bladder for the continuous drainage of waste material therefrom, and a stylet for inserting the retention drainage catheter through the urethra and into the bladder, said catheter and stylet comprising in combination:

A. an elongate flexible cannula formed of a flexible and pliant material having both distal and proximal ends, the length of said cannula being such that said distal end is disposed within the bladder and the proximal end is disposed exteriorily of the urethra, said cannula having

1. a drainage lumen extending from said distal end substantially to said proximal end,

2. means formed on the inner tubular wall of said drainage lumen defining an abutment means adjacent said distal end of said cannula, and

3. expandable means connected to said cannula adjacent said distal end thereof for retaining said distal end within the bladder after passing through the urethra,

4. said distal end of said cannula being open and unobstructed whereby waste material in the bladder flows directly into said drainage lumen at said distal end of said cannula and instrumentation is introduced into the bladder through said drainage lumen,

B. an elongate flexible stylet adapted to be inserted through said drainage lumen, said stylet being longer than said cannula and having

1. at least a major portion of its length of a substantially uniform diameter thiwh will pass through said drainage lumen,

2. means formed adjacent one end of the stylet defining an abutment means for engagement with said abutment means in said drainage lumen, and

3. a tip portion having a smooth rounded end normally projecting beyond said distal end of said cannula,

C. said means defining said abutment means on said cannula comprising a pair of spaced apart annular bosses projecting inwardly of said drainage lumen, the boss adjacent said distal end projecting further inwardly than the other boss, and

D. said means defining said abutment means on said stylet comprising a pair of spaced apart bosses projecting outwardly from said stylet, the boss remote from said distal end of said stylet projecting further outwardly than the other boss,

E. the smaller of said bosses on said stylet being of a diameter to pass the larger of the bosses on said cannula but said bosses otherwise having cooperating abutment surfaces,

F. said bosses on said stylet being spaced to have the abutment surfaces thereof farther apart than the corresponding abutment surfaces of said bosses on said cannula,

whereby said catheter is inserted through the urethra by pushing said catheter therethrough by engagement of the abutment means on said cannula and said stylet until said expandable means enters the bladder to retain said cannula in place, after which said stylet is withdrawn from said cannula, and during insertion of the catheter through the urethra as aforesaid, if the forwardmost abutment surfaces slip past each other the rearwardmost abutment surfaces will engage after said stylet moves forwardly in said cannula to continue the insertion of said catheter.

10. The combination as set forth in claim 9 wherein said cannula is tapered adjacent said distal end thereof to form a gradually widening portion from said distal end, and wherein said smaller and rearwardly disposed of said annular bosses on said cannula is located adjacent the widest point of said gradually widening portion and said larger and forwardly disposed of said annular bosses on said cannula is located within said gradually widening portion so that only said gradually widening portion of said cannula is pushed ahead of said abutment means during insertion of the catheter through the urethra regardless of which said pairs of abutment surfaces is engaged.

11. A retention drainage catheter adapted to be inserted into and retained in the bladder for the continuous drainage of waste material therefrom, and a stylet for inserting the retention drainage catheter through the urethra and into the bladder, said catheter and stylet comprising in combination:

A. an elongate flexible cannula formed of a flexible and pliant material having both distal and proximal ends, the length of said cannula being such that said distal end is disposed within the bladder and the proximal end is disposed exteriorily of the urethra, said cannula having

1. A drainage lumen extending from said distal end substantially to said proximal end,

2. means formed on the inner tubular wall of said drainage lumen defining an abutment means adjacent said distal end of sand cannula, and

3. expandable means connected to said cannula adjacent said distal end thereof for retaining said distal end within the bladder after passing through the urethra,

4. said distal end of said cannula being open and unobstructed whereby waste material in the bladder flows directly into said drainage lumen at said distal end of said cannula and instrumentation is introduced into the bladder through said drainage lumen,

B. an elongate flexible stylet adapted to be inserted through said drainage lumen, said stylet being longer than said cannula and having

1. at least a major portion of its length of a substantially uniform diameter which will pass through said drainage lumen,

2. means formed adjacent one end of the stylet defining an abutment means for engagement with said abutment means in said drainage lumen, and

3. a tip portion having a smooth rounded end normally projecting beyond said distal end of said cannula,

C. said means defining said abutment means on said cannula comprising a pair of spaced apart annular recesses formed in said cannula and projecting outwardly from said drainage lumen, the recess remote from said distal end of said cannula projecting farther outwardly than the other recess, and

D. said means defining said abutment means on said stylet comprising a pair of spaced apart radial projections extending outwardly from the surface of said stylet, the projection remote from said distal end of said stylet projecting further outwardly than the other projection,

E. both said pairs of recesses and projections having forwardly slanting barb-like cooperating surfaces which engage when said stylet is inserted into said cannula,

F. the smaller of said projections on said stylet being of a diameter to pass the larger of the recesses on said cannula but said projections and recesses otherwise having cooperating abutment surfaces,

G. said projections on said stylet being spaced to have the abutment surfaces thereof farther apart than the corresponding abutment surfaces of said recesses on said cannula,

whereby said catheter is inserted through the urethra by pushing said catheter therethrough by engagement of the abutment means on said cannula and said stylet until said expandable means enters the bladder to retain said cannula in place, after which said stylet is withdrawn from said cannula, and during insertion of the catheter through the urethra, if the forwardmost abutment surfaces slip past each other the rearwardmost abutment surfaces will engage after said stylet moves forwardly in said cannula to continue insertion of the catheter.

12. The combination as set forth in claim 11 wherein said cannula is tapered adjacent said distal end thereof to form a gradually widening portion from said distal end, and wherein said farther outwardly projecting recess on said cannula is located adjacent the widest portion of said gradually widening portion and said other recess is located within said gradually widening portion of said cannula so that only said gradually widening portion of said cannula is pushed ahead of said abutment means during insertion of said catheter through the urethra regardless of which of said pairs of abutment surfaces is engaged.
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BACKGROUND OF THE INVENTION

1. Field of the Invention

It is well recognized in the field of Urology that persons lose control of their urinary function. This loss of control may be temporary or permanent, depending upon the cause of the loss of urinary function. Temporary loss may be caused by a disease entity which is curable by medical or surgical treatment, whereas permanent loss of control may be caused by an incurable disease entity or physical trauma resulting in partial or total paralysis of the muscles which cause normal urination. The bladder is a dome shaped container with muscular walls and which accepts urine from the kidneys for temporary storage. During normal voluntary urination, the muscles in the bladder wall contract and simultaneously the sphincter muscle surrounding the opening in the bladder which communicates with the urethra relaxes so that the urine stored in the bladder is released into the urethra and expelled from the body.

The causes for loss of normal voluntary control of the urination process are manifold and the consequences are indeed severe. If urine cannot be periodically expelled from the bladder, the urine becomes stagnant and bacteria multiply at an exceedingly rapid rate, resulting in infection of the bladder. Chemical changes in the urine due to the infection cause painful urination and can also cause general dibilitation of health. If, after infection occurs, the urine retention is still permitted to continue for any considerable length of time beyond normal voluntary urination frequency, ascending infection can occur, that is the infection in the bladder spreads to the ureters and to the kidneys, thereby causing still more serious consequences, such as failure of one or both of the kidneys to function. If the kidneys do not function to cleanse the blood of impurities and form urine, uremia results and death occurs in the absence of the availability of recently developed artificial kidney machines. If, on the other hand, the kidneys continue to function and fill the non-draining bladder with urine, the bladder can burst, thereby emptying the bacteria laden urine into the abdominal cavity. The usual result of this is peritonitis, which is an inflammation of the peritoneum, the membrane that lines the abdominal cavity, and the results of inflammation of this membrane are always serious. The time between the occurrence of acute peritonitis and death may be only a matter of a few hours to a few days depending upon the severity of the infection. Septicemia, an infection of the blood, is another serious consequence of excessive retention of urine in the bladder, since the bacteria in the bladder, ureters and kidneys invades the blood through the minute blood capillaries in these organs.

Obviously other complications, bodily disorders and disfunctions and serious consequences, too numerous to mention herein, can result from failure of proper urination. It is obvious that constant periodic drainage of the bladder to eliminate urine and other body waste material is essential not only to good health but to maintaining life itself.

Techniques of treatment for loss of normal voluntary control of the urination process are relatively few in number. Depending on the nature of the cause, a super-pubic technique involving surgery may eliminate the drainage problem in some circumstances. Since surgery is involved, this treatment is traumatic and severe, and is utilized only when absolutely necessary. Drug therapy is effective in some cases to promote drainage of the bladder, but due to the relatively few causes of loss of voluntary control which will respond to drugs and the ever presence of undesirable side effects, drug therapy is considered to be a relatively ineffective method of dealing with the problem.

2. Necessity for Practice of Invention

Since the loss of voluntary control over the urinary function is typically a secondary effect caused either by disease or trauma, it has become a well established medical practice to relieve the urinary drainage problem mechanically by means of the process of catheterization. If the primary cause of the loss of voluntary urination control is from a curable disease, the catheterization process is maintained on a temporary basis only for so long as necessary until voluntary control returns. If the cause of loss of control is permanent, as in the case of paralysis such as with paraplegics and quadriplegics, the catheterization process must be maintained on a permanent basis in order to maintain life.

In the catheterization process, a tube or catheter is inserted into and through the urethra until the remote or distal end is located within the bladder, usually being disposed just past the sphincter muscle at the juncture of the bladder with the urethra. The near or proximal end of the tube remains outside of the body and there is thus provided a path or channel through which urine in the bladder can drain as the need arises. Once a catheter has been passed through the urethra and inserted into the bladder, it is generally necessary, in connection with the disease and trauma conditions described above, to have the catheter retained in the urinary tract with the distal end of the catheter in the bladder, such retention being in the order of several days to several weeks without removal. Catheters which are designed for use a function are called urinary retention catheters and are typically provided by including an inflatable balloon at the distal end of the catheter which is deflated during insertion of the catheter and which is inflated by passing a fluid, typically water or saline solution through a passage within the catheter, called an inflation lumen. Thereafter, fluid from the bladder drains through the main passage of the catheter, called the drainage lumen.

PROBLEMS OF CATHETERIZATION

Inserting a catheter into the urethra can be a painful and traumatic experience, the degree of pain and trauma depending on the construction of the catheter being inserted, the technique for inserting it, and the experience and the skill of the person performing the insertion whether that person is the doctor or other individual. Since the designers of catheters have no control over the last named characteristic, the present invention has been developed with the first two characteristics principally in mind, but also with consideration for the fact that the catheter may on many occasions be inserted by other individuals who would not be as skilled as the doctor. The reason for possible pain and trauma is that the urethra, whether male or female, is a relatively tortuous tube of varying cross-sectional dimensions and is normally collapsed along most of its length. The upper portion of the urethra is provided with sphincters or valves which it enters the bladder neck. The female urethra is somewhat shorter and straighter than the male urethra but otherwise both are much the same. The urethra is a very delicate organ and cannot withstand any appreciable amount of lateral pressure against the urethral wall without causing some degree of rupture. Since the urethra has a high concentration of pain sensing nerve endings, any distortion, whether of change in size or shape, is very uncomfortable at the least and usually painful, and any trauma to the urethra is accompanied by a great deal of pain. It is not uncommon for the patient to have to be anesthetized in order to insert many common urinary catheters. In addition to the pain, bacteria in the urethra can enter the blood stream if the urethra is traumatized, with the same result discussed above in connection with rupture of the bladder.

Extensive research and development have been carried out over a long period of time in the design of catheters, and a large number of different catheter designs appear in the medical and patent literature. The reason for this is that design characteristics for urinary drainage catheters are highly conflicting from the standpoints of patient discomfort and functionalism. In order to reduce the probability of trauma and resulting pain to the urethra as well as discomfort to the patient during long periods of retention, a urinary drainage catheter should be as thin as possible, highly flexible and pliant, and have a soft rounded end. From the functional standpoint, on the other hand, the catheter must be of sufficiently thick and rigid construction that it will not buckle while being passed through the urethra, it should have as wide a drainage opening and lumen as possible to promote complete drainage and prevent clogging, and the end should be free and unobstructed in order to facilitate the use of the catheter as an aid to the insertion of diagnostic and treatment instrumentation into the bladder. Of great importance is the fact that a retention catheter must have an effective means for retaining the catheter in place in the bladder which will not obstruct either the flow of urine or substantially the complete drainage of urine therefrom, but at the same time has sufficient retaining capability that a patient, particularly a senile patient, cannot forcibly pull the catheter out of the bladder and into the urethra thereby causing extreme damage thereto. Further, any urinary drainage catheter must be formed of a material totally inert to the effects of urine and other waste materials, be capable of absolute sterilization, and be manufacturable to strict tolerances, in high volume and at low cost considering the disposable nature of the product. Still other criteria may be apparent to those skilled in the art.

THE PRIOR ART

In view of the foregoing diverse criteria, the basic design of commercially available retention catheters has changed very little over the past half century, and the well known Foley retention catheter is almost universally used by doctors, hospitals, nursing homes, etc. to alleviate loss of voluntary bladder control. U.S. Pat. Nos. 2,892,458; 2,936,761; 3,292,627 and 3,394,705 are mentioned as illustrating typical prior art catheters which are usually formed of relatively thick walled construction so as to be insertable without buckling, have a rounded solid tip to prevent trauma to the delicate lining of the urethra, and have side openings adjacent the tip to communicate the interior of the bladder with the drainage lumen. The prior art catheters also have an inflatable balloon portion beyond the drainage opening in order to retain the catheter in place. These catheters, and many more like them, are undesirable from the standpoint that considerable pain may be experienced in introducing a relatively wide, semi-rigid catheter into a relatively narrow urethra. Further, the small side openings can easily clog from clots of sediment material which collects in the bottom of the bladder. Still further, as a result of the solid tip, it is impossible to pass diagnostic or treatment instrumentation through the catheter for the purpose of inspecting or treating the interior of the bladder. The capability of inserting instrumentation through the catheter after it is in place is very important in the urological practice since prior treatment involves the use of anesthesia in order to insert steel tube instrumentations as has been the practice.

In U.S. Pat. No. 2,677,375, recognition was given to the desirability of removing the fixed rounded tip so as to provide a drainage opening adjacent the inflatable retention balloon. Strips are provided across the opening for engagement by an inserting stylet. This construction is disadvantageous in that the strips likely to obstruct the passage of sediment clots and thus clog the drainage opening, and even more harmful is the fact that the insertion of such a blunt end as is apparent in this device is almost certain to cause considerable trauma to the delicate wall of the urethra. It is also apparent that is would be at least difficult, if not impossible, to pass instrumentation through this catheter in view of the strips across the open end. Such a device would be wholly unacceptable to the urological practitioner.

A significant aspect of the presention invention is the provision of an improved stylet which is utilized both during insertion of the catheter through the urethral passage and thereafter as a cleaning implement. U.S. Pat. Nos. 2,118,631; 2,164,926 and 2,856,934 are cited as representative of prior art stylets which are utilized solely to assist in inserting the catheter, the first two being of the typical push rod type and the third being of the filiform type. Although the use of a stylet to insert the catheter obviates the problem of bucking of the catheter during insertion and thereby permits the catheter to have a relatively thin wall construction, the push rod type used in conjunction with a closed end catheter is undesirable from the standpoint that there is no way of accurately ascertaining when the end of the catheter enters the bladder because the stylet blocks the drainage opening or the drainage lumen or both. The filiform device is undesirable because of the possibility of injuring the delicate wall of the urethral passage during the insertion of the filiform unless great care is exercised because of the fact that the filiform is of necessity very thin and therefore must be relatively rigid and sharp nosed. Other disadvantages of this technique for inserting drainage catheters will be apparent to those skilled in the art.

Another significant improvement of the present invention is the novel construction of the inflatable retention balloon to cause the open end of the catheter to expand and widen, which assists in drainage and in retention. Some consideration has been given to this problem as evidenced by U.S. Pat. No. 2,892,458 mentioned above, as well as by U.S. Pat. No. 3,438,375 and 3,889,686. In the first patent, the balloon is constructed to be less inflatable adjacent the lateral drainage opening through the catheter wall so that the balloon cannot overlie and block the opening if the catheter tends to settle in the bladder or is pulled by the patient. In U.S. Pat. No. 3,438,375, the opposite theory is applied and the balloon is constructed to purposely overlie the lateral drainage but be spaced therefrom so that the delicate lining of the bladder cannot be drawn into the opening by sub-atmospheric pressure. In U.S. Pat. No. 3,889,686, a lateral opening is provided below the balloon as well as above so as to promote better drainage. All of these techniques have inherent disadvantages in that they present design problems which are difficult to overcome in manufacturing the catheter, they are not nearly as effective in practice as eliminating the lateral drainage opening altogether so that the inflation balloon presents no interference problem whatever, and they cannot function to allow movement of a stylet to indicate when the balloon is inflated because the rounded tip closes the longitudinal end of the drainage lumen.

SUMMARY OF THE INVENTION

The present invention substantially obviates if not completely eliminates many of the disadvantages of prior art and commercially available urinary retention catheters and also provides advantages and desirable features not heretofore obtainable with such catheters.

The principles of the present invention are embodied in a novel urinary drainage catheter, a novel stylet for use with the catheter and in a novel cooperation in the combination of the catheter and the stylet together.

In general, the catheter comprises an elongate cannula formed preferably although not necessarily of a plurality of layers of flexible and pliant materials, the inner and outer layers being of relatively soft latex rubber and an intermediate layer being of relatively thinner but stronger silicone rubber. The cannula has both distal and proximal ends, the length of the cannula being such that the distal end is disposed within the bladder and the proximal end is disposed exteriorly of the urethra when the catheter is in operative position in the body. The cannula has an inner tubular wall surface defining a drainage lumen which extends from the distal end substantially to the proximal end. The distal end is open and unobstructed so as to communicate the interior of the bladder directly with the full cross-sectional area of the drainage lumen. There is means on the inner tubular wall adjacent the distal end which defines a portion of the drainage lumen of slightly different diameter than the diameter of the rest of the drainage lumen, which means forms an abutment for the stylet used to insert the catheter. The catheter also includes an expandable means preferably in the form of an inflatable balloon connected to the inner and outer layers of the cannula adjacent the distal end for retaining the distal end in the bladder and for expanding the distal end of the cannula so as to widen the opening and to dispose the end of the cannula lower in the bladder than it is with the balloon uninflated. In one embodiment, the abutment forming means forms a hinge about which the distal end expands and the abutment means distorts to a shape which allows the stylet to pass beyond the abutment means and move freely back and forth for at least a limited distance, thereby providing an indication that the balloon has inflated.

The stylet comprises generally an elongate flexible body member of substantially uniform diameter throughout a major portion of its length. Adjacent one end of the body member is means defining a portion of different diameter than the diameter of the body member and defining an abutment surface adapted to engage with the abutment means disposed in the cannula when the stylet is inserted therein. The stylet is provided with a tapered tip element on the end adjacent the abutment surface, the tip element having a relatively smooth rounded end. The tip element is removably connected to the end of the body member so that it can be removed from the body member after the stylet is withdrawn from the catheter, and a brush element is provided which is connectable to the body member for cleaning the catheter. Both the body member and the tip element have a central bore of relatively small diameter so that the flow of urine therethrough affords a positive indication that the distal end of the catheter has entered the bladder.

Having briefly described the general nature of the present invention, a principal object thereof is to provide a retention drainage catheter and stylet for use therewith which avoids the disadvantages of prior art constructions and provides advantages not heretofore attainable in devices of this nature.

Another object of the present invention is to provide a retention drainage catheter and stylet for use therewith which avoids to the fullest possible extent any likelihood of injury to the urethra during insertion of the catheter.

Another object of the present invention is to provide a retention drainage catheter and stylet for use therewith which is designed to render insertion relatively simple and with a minimum of discomfort so that the insertion process can be carried out without the need for anesthesia.

Another object of the present invention is to provide a retention drainage catheter and stylet for use therewith in which the catheter and stylet have a cooperating abutment relationship by which the stylet is used to insert the catheter into the bladder and which does not interfere with the free flow of urine or other waste materials through the catheter.

Another object of the present invention is to provide a retention drainage catheter and a stylet for use therewith in which the entire full width portion of the catheter is pulled through the urethra rather than a portion thereof being pushed therethrough.

Another object of the present invention is to provide a retention drainage catheter which is constructed to provide the widest possible drainage opening from the bladder directly into the drainage lumen of the catheter in order to minimize if not altogether prevent clogging of the drainage opening due to sediment material collecting in the bladder.

Another object of the present invention is to provide a retention drainage catheter through which various types of instrumentation may be passed into the bladder for performing diagnostic or treatment techniques therein.

Another object of the present invention is to provide a retention drainage catheter having a novel inflatable retention balloon construction which causes the distal end of the catheter to expand to provide a still wider drainage opening whic