Sew-in Urethral Catheter

Abstract

A securing means for a drainage catheter is disclosed, comprising a securing collar on the catheter, a fixation material being embedded in the collar for use in attaching the catheter firmly and without slippage to a patient. The fixation material may be a suture and needle, a wire clasp, or the like, the fixation material, collar and catheter forming a unitary, ready-to-use device. The catheter also carries a fixation band spaced from the securing collar, the band being attached to the catheter to provide further anchoring means for securing the catheter.

Description

BACKGROUND OF THE INVENTION

The present invention relates, in general, to a novel method and apparatus for securing a catheter to a patient so that the catheter will function without the danger of displacement due to motion of the patient. More particularly, the invention relates to a securing collar for a catheter, the collar containing a permanently embedded fixation material by which the catheter may be quickly and securely fastened to the patient.

As is well known in the medical arts, after many types of surgical procedures it is necessary to provide continuous or intermittent drainage in the area of the incision, or to provide such drainage for body cavities affected by the operation. This is particularly the case in gynecologically related operations, where it becomes necessary to provide postoperative bladder drainage. Several methods for providing such drainage are known, wherein one end of a suitable catheter is placed in the cavity, with the other end leading to an external container for receiving the fluids so removed. Such catheters must be secured in place after they are properly positioned so that motion by the patient will not displace them, and numerous catheters and securing procedures have been designed to accomplish this purpose.

Among the prime requirements for drainage catheters is that they be of a material which is durable, yet non-irritating, pliable, non-hardening, and easy to clean, so that they do not require frequent replacement. The catheters must be easily placed and attached, and must be held securely, so that drainage may be established without trauma. Although prior art catheters and methods of attaching catheters meet many of these requisites, to date no catheter is available which provides all of the foregoing features, yet can be positioned and secured by medical personnel in a very short period of time, with essentially no tissue injury, and with minimal risk of complications. Inasmuch as a major application of the present invention is in the provision of postoperative bladder drainage by way of a urethral catheter, the present invention will be described in terms of a catheter specifically designed for such a purpose; however, it will be evident that the securing means and the resultant method of securing the catheter in position are applicable to catheters used for other purposes.

In general, two methods of providing postoperative bladder drainage in female patients have been practiced in the prior art. The first method involved the insertion of a thin tube through the urethra into the bladder, the tube being enlarged at the interior end to hold it in place. The enlarged end of this type of catheter rests on the trigonum vesicae, a triangular area of the interior of the bladder, thus covering the orifice of the urethra and preventing normal urination. This method, known as Foley catheterization, inhibits recovery of the patient by failing to encourage voluntary control of micturition, and in addition exerts a downward pull on the urethral orifice and its sphincter which is detrimental, particularly after surgery in this area, thereby often producing patient discomfort and a resultant psychological block to micturition.

A second method of obtaining bladder drainage is by surgical placement of a catheter through the abdominal wall, as by suprapubic insertion of a catheter into the bladder through a trocar. This procedure has the advantages of permitting continuous drainage and of encouraging the patient to micturate at the earliest possible time, but, as in any surgical operation, the possibility exists of complications such as hematuria or hematoma formation due to hemorrhaging. In addition, the performance of suprapubic cystostomy raises the possibility of drainage to abdominal organs, prolongs the operation time, and increases trauma. For these reasons, the surgical procedure has not found wide acceptance, and work continues in an effort to find a satisfactory and reliable substitute for the conventional Foley catheterization.

Recently it has been found that many of the problems of the prior art could be overcome through the use of a small diameter catheter which is inserted into the bladder through the urethra. The catheter, which may be, for example, a number 10 Bard plastic utility catheter, is then sutured to the urethral meatus, or opening. Care must be taken, however, that there is an adequate inclusion of tissue to prevent the silk suture from cutting through the meatus, and the suture must be tied to the catheter three times with knots spaced at 1cm intervals to prevent the catheter from slipping. This catheter arrangement permits continuous drainage, and since it does not close off the urethral orifice in the bladder, it may be plugged to allow the patient to attempt to void around the catheter. The advantages of this technique include reduction in the length of time the catheter must remain in place, improvement in patient comfort, ease of obtaining accurate measurement of residual urine, and avoidance of the complications inherent in the prior surgical procedures.

Although a marked improvement in the art, the use of the small catheter described above presents certain practical problems in its use, for it is difficult to fix the catheter in place securely so that it will not be displaced when the patient moves about; it has been found that even with three spaced sutures, the catheter may still slip. There is also a problem of the suture cutting through the catheter tubing, or of the catheter pulling out of place when the distal end is moved. Finally, there is some problem in the use of the foregoing catheter arrangement in that adhesives are often used in an attempt to hold the catheter in place, and these may retain soilage from discharges, and thus accumulate infected materials.

SUMMARY OF THE INVENTION

It is, therefore, an object of the present invention to provide a drainage catheter which will permit secure, continuous or intermittent drainage of a body cavity with minimal movement of the tube, and no irritation from the fixation.

It is a further object of the invention to provide means for quickly and easily securing a catheter to a patient in order to permit drainage of a body cavity, the securing means firmly holding the catheter in place.

It is another object of the present invention to provide a simple yet effective securing means for catheters which permits establishment of drainage without trauma.

Another object of the present invention is the provision of a securing means for a drainage catheter, the securing means being strong, non-irritating, easy to use, and resistant to soilage.

A further object of the present invention is the provision of a securing means for a drainage catheter which is formed as a part of the catheter, thereby providing a unitary piece of equipment which is easy to handle, and which results in an insertion procedure that is simple and which can be performed by medical personnel in a very short time.

Another object of the invention is the provision of a securing collar for a catheter, the collar being either a part of the catheter itself or separate and adjustable, a suitable fixation material such as a dacron suture, a steel wire, or the like, being embedded in the collar and carrying at one end a penetrating needle, the collar fixation material and needle being a unitary securing means.

An additional object of the present invention is the provision of a drainage catheter having at or near its proximal end a securing collar, and at or near its distal end a fixation band, whereby both ends of the catheter may be secured to the patient to prevent displacement of the catheter.

In a preferred embodiment of the invention, a discharge catheter is formed of a slender, flexible tube having a proximal end adapted to be inserted into a body cavity. A securing collar is permanently located on the outer surface of the catheter a predetermined distance from the proximal end, the collar being of the same material as the catheter and effectively forming a unitary part thereof. Embedded in the collar and encircling the catheter is a length of fixation material, such as a dacron suture, for use in anchoring the catheter to the patient. The ends of the suture extend from the collar, with one end being affixed to a curved penetrating needle. This unitary arrangement of the collar, suture and needle assures ready availability of the means for securing the catheter in place, and thus reduces the time required to anchor the catheter.

In a second embodiment of the invention, the securing collar is not permanently attached to the catheter, but is adjustable and adapted to be firmly fastened to a selected location on the catheter. This adjustable collar is generally C-shaped, and is made of a flexible material so that it can be drawn tightly against the outer surface of the catheter. The inner periphery of the collar is provided with a metal sleeve carrying a plurality of inwardly-extending gripping teeth so arranged that when the collar is closed about the catheter, the teeth slightly penetrate, or indent, the surface thereof to hold the collar in a selected position.

In either embodiment of the collar, the suture and needle arrangement described above may be replaced by other suitable fixation materials. For example, a steel wire may be embedded in the collar in place of the suture, with the ends of the wires being joined to form an eyelet at the outer surface of the collar. A metal needle anchor, or clasp, may then be connected to the eyelet, the clasp consisting of a first curved arm forming a penetration needle and a second spring clasp arm adapted to receive the needle point in the manner of a safety pin, thereby to form a loop which may be opened to send the curved arm through the tissue to which the catheter is to be attached.

The distal end of the catheter carries a fixation band which may be formed as a unitary part of the catheter, and which serves to hold the exposed end of the catheter in place. The band may be attached to the patient or to a dressing by an elastic band, may be sewed into place with a suitable suture material, or may be fixed with adhesive, thereby to prevent pull on the proximal fixation area.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and additional objects, features and advantages of the present invention will be further appreciated from a consideration of the following detailed description of the preferred embodiments thereof, selected for purposes of illustration, and shown in the accompanying drawings, in which:

FIG. 1 is a side elevation of a drainage catheter including a unitary securing collar at its proximal end and a fixation band at its distal end;

FIG. 2 is a cross-sectional view of the catheter and securing collar of the invention, taken along the lines 2--2 of FIG. 1;

FIG. 3 is an enlarged view of the swedged needle used in the device of FIG. 1;

FIG. 4 is a cross-sectional view at 4--4 of FIG. 3;

FIG. 5 is a cross-sectional view of the catheter and fixation band of the invention, taken along line 5--5 of FIG. 1;

FIG. 6 is a top plan view of a securing collar made in accordance with a second embodiment of the invention;

FIG. 7 is a top plan view of a securing collar made in accordance with a third embodiment of the invention; and

FIG. 8 is an enlarged cross-sectional view of the clasp illustrated in FIG. 7.

DESCRIPTION OF PREFERRED EMBODIMENTS

Turning now to a detailed consideration of the drawings, there is illustrated in FIG. 1 a preferred form of the present invention, wherein a drainage catheter 10 is shown with a securing collar 12 located at its proximal end 14 and with a fixation band 16 at its distal end 18. The catheter is preferably fabricated in the form of a small diameter tube from a pliable, easy-to-clean, non-irritating, non-hardening material such as Silastic, a rubber-like composition containing organosilicon polymers produced by Dow Corning Corporation. When the catheter is to be used for placement in a patient's urethra to effect bladder drainage, the maximum size of the tube should be about that of a standard number 10 catheter, having an outer diameter of about 0.125 inch and an inner diameter of about 0.062 inch. This size is sufficiently large to provide proper drainage, yet is small enough to permit the patient to void around the catheter as soon as bladder tone is sufficient to execute micturition. Where other than urethral bladder drainage is to be performed, larger diameter tubes may be used, the securing collar and fixation band providing the same advantages for such applications as are available in the preferred usage.

The proximal end 14 of the catheter is adapted for insertion into the body cavity which is to be drained, and for this reason includes a rounded end 20 and a plurality drainage openings such as those illustrated at 22 through 26. The number, size, and spacing of these openings may vary, depending on the particular use of the catheter, in accordance with known procedures.

When the catheter is used for urethral catheterization, the securing collar 12 preferably is located about 10cm from the rounded end 20 of the catheter, thereby providing an adequate length of tubing to insure that the openings 22-26 are positioned in the bladder when the collar 12 is located at or near the urethral meatus. The collar, which is further illustrated in FIG. 2, is generally annular in shape, having an inner diameter 28 corresponding to the outer diameter of the catheter tubing. Embedded in the collar is a fixation material such as a suture 30, the suture extending around the collar and thus encircling the catheter. The suture extends out of the collar to provide first and second free ends 32, 34, one of the free ends 34 carrying a swedged needle 26, which is a conventional suturing needle that is permanently attached to the suture material.

The collar may be formed by placing a length of the fixation material in an annular mold and filling the mold with a flowable plastic material, preferably the same material used to form the catheter. The plastic may then be cured to firmly hold the suture so that it cannot easily be pulled out. After removal from the mold, the collar may be placed over the catheter and fixed in position by an appropriate adhesive or solvent, whereby the collar is fused to the catheter to form a single unit. The suture encircles the catheter and is embedded in the collar so that it cannot cut the catheter, with the ends of the suture extending from the collar for use in anchoring the device in place.

Needle 36, which is illustrated in greater detail in FIG. 3, is permanently attached to the fixation material 30 in known manner so that it will form a part of the unitary catheter and securing collar structure, whereby ti will be immediately and conveniently accessible to medical personnel when placing the catheter. The needle is preferably of a somewhat oval cross-sectional shape, as illustrated in FIG. 4, and is of a size sufficient to permit easy handling without the use of a needle holder.

The arrangement described above thus provides a unitary catheter set which is ready to use, and which allows trained medical personnel to insert or replace a urethral drainage catheter and to anchor it in position by suturing or stitching it to adjacent tissue, and more particularly to the anterior portion of the external urethral meatus, quickly and easily, without pain, and with essentially no tissue injury. When the collar has been thus sutured in place, the catheter is firmly anchored and thereby eliminates the problems of prior devices, as described above.

To insure stability of the catheter, and to prevent the suture from cutting through the tissue to which the catheter is anchored, the additional anchoring means 16 is provided at the distal end 18 of the catheter. This fixation band, which is shown in elevation in FIG. 1 and in a top view in FIG. 5, preferably is fabricated from the same material as the collar 12, and may be formed in a suitable mold. The band includes a central tubular portion 40 having an inner diameter corresponding to the external diameter of tube 10, whereby after formation the band may be slipped over tube 10 and secured at the distal end 18 thereof by means of a suitable adhesive or solvent. The band is formed with a pair of flaps 42 and 44 extending laterally of the tubular portion 40, the three parts of the band defining at least one generally flat surface 46 adapted to lie against the patient's skin or against a dressing. Flaps 42 and 44 carry a plurality of small holes 50 through which a needle and suture may pass, and include elongated openings 52 and 54, respectively, near their ends for receiving a belt or elastic band 56.

The fixation band 16 may be used to secure the distal end of the catheter in any one of several ways in order to prevent pulling on the urethral fixation area. Thus, band 16 may be attached to the patient's leg or abdomen, to a dressing, or the like, by means of a suitable adhesive; alternatively, the band may be affixed by means of sutures passed through holes 50. Finally, it may be desired to attach the band to the patient by means of an elastic belt 56, which may be connected to the band by means of slots 52 and 54, and which may be adjusted as to its length by means of a buckle 58. The end of the catheter extending beyond band 16 provides the drainage outlet, and thus should be sufficiently long to permit easy connection to a suitable drainage container, preferably through a valve such as a stopcock.

FIG. 6 is illustrative of a modification of the securing collar shown in FIGS. 1 and 2, and is adapted for use in a drainage catheter where a variable length of tubing may be required between the end 20 of the catheter and the collar. The modified securing collar 60 is a split collar, being generally C-shaped rather than annular, and further differs from the device of FIGS. 1 and 2 in the provision of an inner gripping sleeve 62. Sleeve 62 is a malleable metal facing for the inner surface of collar 60, and is provided with a plurality of small, upstanding sharp teeth, or prongs, 64 which may be formed, for example, by perforating the sleeve with a sharp instrument. As before, a suture material 66 is embedded in the collar, with free ends 68 and 70 extending therefrom, and one end of the suture carrying a swedged needle (not shown). The ends of the suture extend out of the collar at or near the split 72, but preferably on the upper or outer surface of the collar so that the suture can be used to tie the collar firmly around the catheter, after the collar is positioned at the desired location, and to form the stitches necessary to secure the collar in place.

The split collar may be formed in a mold substantially in the manner described above with respect to collar 12, with the metal sleeve 62 preferably being first placed in the mold so as to be securely bonded to the collar by means of plastic flowing through or into the holes in the sleeve which remain after formation of prongs 64. The collar so formed may then be placed on the catheter at the desired location, and when the suture is tied, the collar is closed around the catheter so that the metal prongs will produce slight indentations in its outer surface, thereby holding the collar in place and preventing slippage of the catheter. The size of the collar will depend upon the diameter of the catheter, the collar being selected so that when properly positioned and tied it will grip the catheter without compressing it. The adjustable collar permits variation of the length of the catheter in the bladder, in the case of urethral catherization, as well as facilitating the use of the catheter for drainage of other body cavities.

As illustrated in FIGS. 7 and 8, the fixation material used with the securing collar need not be a conventional suture material, but instead may consist of a metal spring clasp, as generally indicated at 74. In this embodiment, securing collar 76 takes the general form of collar 12, but in place of suture 30 a wire anchor 78 is embedded in the collar during fabrication. The anchor extends out of the collar to form an eyelet 80 adjacent the outer surface of the collar, by means of which the spring clasp 74 is hingedly connected to the collar.

Clasp 74 consists of a first, curved, needle-like arm 82 having a sharp, pointed end 84 (FIG. 8), and a second, generally straight arm 86 having a hollow end 88 adapted to receive needle point 84. The first arm of clamp 74 forms a loop at its upper end, the loop having a diameter of about 1 to 11/2 cm, and is of a size to permit easy insertion through tissue to secure the collar 76 and the catheter 10 to which it is fixed. Arm 82 is preferably formed from a resilient spring-like metal so that its end 84 may be placed in the hollow end 88 or arm 86, and will remain there, keeping the clasp closed in the manner of a safety pin. The clasp may then be opened by flexing the arm 82, to attach or remove the clasp from tissue, as desired.

The lower end of clasp 74 is formed into a second eyelet 90 which is adapted to engage eyelet 80, thereby forming a hinged connection between the clasp and collar 76 which is freely movable for ease of handling. The collar 76 is fused or otherwise secured to the exterior surface of the catheter 10 so that anchor wire 78 encircles the tubing and holds it securely, without danger of slippage or of having the wire cut through the catheter wall. The clasp thus becomes an integral part of a unitary catheter and securing device. Although the securing collar has been shown in each embodiment as being fabricated separately from and then fastened to the catheter, it will be apparent that the collar may be molded directly onto the surface of the tubing, or may be formed as a part of the tube. Similarly, the distal fixation band may be molded directly on the catheter, or otherwise fabricated, instead of being formed in a separate mold and attached to the catheter in the manner disclosed.

Thus, there has been described a new and novel means for securing drainage catheters to patients quickly, easily and without trauma. The fixation material is permanently embedded in a securing collar and thus encircles the catheter to hold it securely, without slippage or cutting of the tubing, whereby a single unitary device is provided. The securing device is relatively free from soilage, and does not produce the irritation and allergies that can be caused by adhesives. The catheter may be used for urethral bladder drainage, for suprapubic insertion, or for drainage of other cavities, and provides in each case substantial advantages over prior art methods and devices. With the present arrangement, the patient may be permitted to go home with the device in place, without increased risk of displacement or injury.

Numerous variations and modifications of the inventive concept herein described will be apparent to those skilled in the art, and it is therefore described that the foregoing description be taken as illustrative and that the true spirit and scope of the invention be defined by the following claims.

Claims

I claim:

1. A drainage device comprising a catheter, securing means including annular collar means surrounding said catheter and holding it against movement, and unitary fixation means embedded in said collar and at least partially encircling said catheter, said fixation means having free ends extending out of said collar and adapted to provide a secure connection between said catheter and adjacent tissue.

2. The drainage device of claim 1, wherein said collar means comprises a split collar which may be adjustably positioned on said catheter, and sleeve means fastened to the inner surface of said collar to prevent relative movement between said collar and said catheter when said collar is tightened around said catheter.

3. The drainage device of claim 2, wherein said sleeve means is a malleable metal having a plurality of upstanding teeth, said teeth being adapted to grip without puncturing the outer surface of said catheter to anchor said collar to said catheter.

4. The drainage device of claim 3, wherein said collar is generally C-shaped, and sized to fit around said catheter without compressing said catheter.

5. The drainage device of claim 1, wherein said collar is permanently attached to said catheter to prevent relative motion between said catheter and said collar, the collar being of the same material as the catheter and effectively forming an integral part thereof, whereby said catheter, collar, and fixation means comprise a unitary device.

6. The drainage device of claim 1, wherein said unitary fixation means comprises suture means encircling said catheter, with at least one of said free ends carrying a swedged needle.

7. In a drainage device for providing continuous or intermittent drainage of fluids from a body cavity, a catheter having a proximal end for insertion into said cavity and a distal end for drawing off said fluids, and securing means at the proximal end of said catheter for holding said catheter in a selected position, said securing means including a collar and unitary fixation means embedded in said collar and at least partially encircling said catheter, said fixation means extending out of said collar and adapted to provide a quick, secure connection between said catheter and tissue adjacent the opening to said body cavity.

8. The drainage device of claim 7, wherein said collar is permanently attached around said catheter whereby said catheter, collar and fixation means form a unitary device, and whereby said unitary fixation means comprises suture means embedded in and encircling said catheter and having at least one free end to which a needle is permanently affixed, whereby said catheter may be attached to said tissue by said suture.

9. The drainage device of claim 7, wherein said collar is permanently attached around said catheter, said unitary fixation means comprising an anchor wire embedded in and said collar and encircling said catheter and spring clasp means hingedly attached to said anchor wire, said spring clasp means permitting said catheter to be attached to said tissue.

10. The drainage device of claim 7, wherein said collar is adjustably attached around said catheter, said collar including an inner face comprised of a plurality of small sharp teeth adapted to grip said catheter when said collar is closed around said catheter.

11. The drainage device of claim 10, wherein said fixation means comprises suture means having at least two free ends extending out of said collar for securing said collar to said catheter.

12. The drainage device of claim 7, wherein said catheter is a urethral catheter having a plurality of drainage openings at its proximal end for bladder drainage, said securing means being so located on said catheter as to be adjacent the external urethral meatus of a female patient when said catheter is positioned for urethral bladder drainage, whereby said unitary fixation means permits connection of said catheter to said meatus.

13. The drainage of claim 12, further including a fixation band at the distal end of said catheter for securing said distal end.

14. A drainage device comprising a catheter, securing means including annular collar means surrounding said catheter and holding it against movement, and unitary fixation means including an anchor wire embedded in said collar and spring clasp means attached to said anchor wire.

15. The drainage device of claim 14, wherein said spring clasp means comprises a first curved needle-like arm and a second generally straight arm adapted to receive the end of said first arm.

16. The drainage device of claim 15, wherein said first arm has a sharp, pointed end and said second arm has a hollow end adapted to receive said pointed end of said first arm to close said clasp, said first arm being resilient whereby said clasp can be opened and closed.

17. The drainage device of claim 14, wherein said anchor wire and said spring clasp means are formed with cooperating eyelets whereby said spring clasp may be hingedly attached to said anchor wire.