KR20060090721A - Incontinence Device Insertion Kit - Google Patents

Abstract

 The kit includes a relatively flexible elastomeric shaft having a closed loop bladder retention structure in the distal half and a urinary incontinence device having a vestibule connecting the retention structure at an adjacent end. The insertion assembly includes one or more rigid shafts that protrude longitudinally from the finger grip and a placement base member having finger grips at adjacent ends. The rigid shaft includes a device connection element at the distal end. The kit further includes a tubular handle referred to herein as a placement tube for receiving the urinary incontinence device within the lumen just prior to placing the incontinence device into the urethra. The placement tube may slide over the rigid shaft to assist in mounting the incontinence device into the lumen of the placement tube. The diameter is configured such that the retention loop collapses and forms a straight line. The kit can be used to push the urinary incontinence device from the placement tube into the urethra and additionally includes a plunger adapted to fit within the lumen of the placement tube.

Description

Incontinence Device Insertion Kit {INCONTINENCE DEVICE INSERTION KIT}

The present invention relates to a system for the treatment of female stress incontinence in women, and more particularly to a kit comprising components to help deploy the incontinence device in the urethra of a woman.

Applicant's U.S. Patent No. 4,311,689B1 is intentionally suitable for operation with a bladder neck to prevent the device from being discharged during pissing, and is retained in the form of a closed loop at the distal end of the shaft member. A urinary incontinence device is described which has a structure and is preferably sized to secure to a female element, consisting of a silicone, flexible, flexible elastomeric shaft member. The device further includes a vestibule located proximal to the urethral meatus and a proximal wing-like retention structure adapted to work with each other to prevent movement upward. do.

In order to insert the urinary incontinence device, a lumen is provided to accommodate the straightened stylet. As the stylet is fully inserted, the end retention loops are generally provided in a straight line to exhibit a low profile. The tip portion is then lubricated, and the device is inserted by advancing the end retaining structure straight to the top of the urethra, through the urethral hole, on the stylet, until the end retaining device is positioned in the patient's bladder. . At this point, the stylet is removed and the loop is reformed on the distal end of the shaft.

 While the insertion methods and devices described in US Pat. No. 4,311,689B1 are safe and effective, there is a voice of concern among some patients using rigid stylets. Some patients have a sense of fear that the hard stylet penetrates through the wall that forms the stylet lumen, which can cause the urethral wall to be injured as the incontinence device is inserted.

It is therefore a primary object of the present invention to provide a device and method for inserting an incontinence device in a woman's urethra, which does not require the use of a rigid stylet wire to initially place the device in a straight line within the urethra.

A further object of the present invention is to provide an insertion mechanism and an incontinence prevention device as a kit used by a patient at home and without the help of a medical professional.

The present invention provides kits for use in treating neurological incontinence in women. The kit includes a urinary incontinence device having a relatively flexible elastomeric shaft having a closed loop bladder retention structure closed at the distal half and a vestibule connecting the retaining structure at the proximal end. The insertion assembly includes a deployment base member having one or more rigid shafts that protrude longitudinally from the finger grip and finger grips at adjacent ends. The rigid shaft includes a device engagement element at the distal end. The kit further includes the tubular handle referred to herein as a placement tube for receiving the urinary incontinence device inside the lumen just prior to placing the urinary incontinence device into the urethra. The placement tube may slide over the rigid shaft to assist in mounting the incontinence device into the lumen of the placement tube. The diameter is configured such that the retention loop collapses and forms a straight line. The kit can be used to push the urinary incontinence device from the placement tube into the urethra and additionally includes a plunger adapted to fit within the lumen of the placement tube.

The urinary incontinence device can be mounted with a placement tube just before it is self-placed into the interior of the urethra, which allows the retaining loop to prevent opening of the loop retaining structure as it reaches a position inside the bladder. Do not acquire. In addition, since the patient does not need to contact the urinary incontinence device, this minimizes the occurrence of infection and maintains a sterile state.

Further features of the invention will be described in accordance with the features of the appended claims. Those skilled in the art will understand preferred embodiments that can be readily used as a basis for designing other structures, methods and systems for carrying out some of the objects of the present invention. Therefore, equivalents are considered to be included in the claims as they do not depart from the scope and spirit of the invention. The foregoing and other features and advantages of the present invention will become apparent in accordance with the description of a preferred embodiment of the present invention as shown in the accompanying drawings.

1 is a perspective view of a kit comprising a preferred embodiment of an associated insertion assembly and an incontinence device, all housed within a sterile package;

2 is a side view of the placement base member in the embodiment of FIG.

3 is a cross-sectional view taken along line 3-3 of FIG.

4 is a perspective view of a placement tube housed in the kit of FIG. 1.

5 is a partial cross-sectional view of a placement tube mounted on a placement base member prior to use.

6 is a perspective view of a batch push rod;

7 is a side cross-sectional view of a placement tube including a fully inserted push rod member.

8 is a perspective view showing an alternative embodiment of the present invention.

* Symbol description *

10: parts kit

14: incontinence prevention device

16: placement base member

18: batch tube

20: push rod plunger

24: shaft

26: loop

28: adjacent retaining member

According to FIG. 1, a sterile package containing an incontinence prevention device 14, a deployment base member 16, a deployment tube 18 and a pusher plunger 20 A parts kit 10 is shown that includes a sterile package 12. The kit includes a supply of gel lubricant (not shown) for convenience. As the kit parts are sealed in the package 12, the package is sterilized by injecting a bactericide such as ethylene oxide into the package or by applying gamma radiation to the package in a conventionally known manner.

The urinary incontinence prevention device 14 can be manufactured according to the technique of my patent 6,311, 689B1, which is incorporated by reference. However, the device is not required to have a stylet lumen herein. The device comprises an extended, flexible elastomer shaft 24 fixed to the distal end of the shaft 24 and having an enlarged closed loop 26, preferably made of silicone rubber, a flexible elastomeric material. do. The proximal retention member 28, which is also made of a flexible material and in the form of a wing-like protrusion, is configured to align the vestibule close to the urethral apertures arranged on the proximal ends of the shaft 24. do.

More detailed information on the shape and size of the urinary incontinence prevention device 14 is given in the aforementioned patent 6,311,689B1.

More specifically, the device 14 first mounts the device 14 with the placement tube 18 in the manner already described, positioning the distal end of the delivery tube close to the urethral cavity, It is self-inserted into the female urethra by expelling the device 14 from the deployment tube 18 using a deployment plunger 20 such as the device.

When packaged into a device 14 pre-incorporated within the lumen of the placement tube 18, the interior of the placement tube 14 is because the retention loop 26 of the device 14 can take a permanent set over time. The arrangement of the urinary incontinence preventing device 14 is arranged to ensure that the retaining loop 26 fully extends in the form of an open loop when the loop is inserted into the bladder unconstrained by the transfer tube 18 or urethra. This can be achieved in a relatively short time prior to use of the device. It is also important to keep the device 14 sterilized and to ensure that it is not in contact with the patient's finger during the insertion process. The transfer kit 10 of the present invention ensures this result.

Referring to FIG. 2, a side view of the placement base member 16 of FIG. 1 is shown. In a preferred embodiment, it includes a finger grip element 30 having a recessed central portion 32 defined by a peripheral wall 34 and which can be configured in a somewhat semi-circular shape. do. With this configuration, the device 16 can be gripped more easily between the index finger and thumb of the user's hand.

A longitudinally extending rod 38 projecting longitudinally from the base 36 of the finger grip element 30 is an integrally formed L, such as a device engagement element 40 formed at its distal end. Has a hook in the form of a child. According to the embodiment of FIG. 2, the placement base member 16 has a second stiffness with a stop member 44 integrally molded at its distal end and a longitudinally extending rail 42. It further includes. The rail 42 preferably has a somewhat I-shaped cross section as shown in more detail in the cross-sectional view of FIG. 3.

The length of the rail 42 is greater than the length of the first rigid rod 38 by a predetermined size. Without limitation, the length of the first rod 38 may be approximately 92.75 mm and the length of the rod 42 may be 107.25 mm.

Referring to FIG. 4, a perspective view of the placement tube 18 of the kit 10 is shown. The tube 18 has a distal end 44 and a proximal end 46, including a lumen 48 extending between the distal end and the proximal end. An insertion limit 50 projects integrally and protrudes perpendicularly to the longitudinal axis of the tube 18 at the distal end 44. The lower end of the insert limit member 50 comprises a T-shaped notch 52. When the first rod 38 of the placing base member 16 is arranged inside the lumen 48 of the placing tube 18, it connects the guide rail 42 comprising the second rod of the placing base member 16. Dimensions are formed. The lumen 48 is shaped to receive a rigid rod 38 with sufficient spacing so that the tube can slide against the rod 38. The opposite sidewall surface of the tube 18 is formed with a concave portion at 54, which surface is knurl to assist in gripping by the user.

To help insert the retaining loop 26 of the urinary incontinence device 14 into the placement tube 18, a flared or oval opening is provided on an adjacent end of the placement tube, the opening having a grooved edge. (chamfered edge, 49). Due to this shape on the distal end of the placement tube, the retaining loop 26 is formed of segments consisting of two consecutive continuous parallel straight lines by pulling the hook-shaped device connection element 40 into the lumen 48 of the placement tube. do. In addition, the lumen of the placement tube may consist of an elliptical cross section over its entire length, or may be deformed into a circular cross section at a predetermined point along the length, as reflected in FIG. 4.

5 shows the placement tube 18 in an enclosed state with respect to the first rod of the placement base member 16. Here is shown how the T-shaped notch 52 on the retaining limiting member 50 is connected with the guide rail 42. Also in FIG. 5, the length of the placement tube 18 is defined to be slightly shorter than the length of the first rod 38 so that the hook-shaped connecting element 40 extends outward from the distal end 46 of the placement tube. Shown.

By mounting the urinary incontinence device 14 with the placement tube 18, the device is packaged onto the hook-shaped element 40 in the space between the adjacent end 46 and the element 40 of the placement tube. ) Is formed as a loop 25. That is, the kit comes with a loop 26 surrounding the L-shaped hook element 40, thereby preventing the user from contacting the sterilization device 14. The finger grip 30 is gripped between one hand and the thumb of the user described above, the thumb and the other hand of the user described above are positioned on the surface 54 of the placement tube, and the placement tube can slide in the distal direction. This causes the retaining loop to be pulled into the lumen 48 of the placement tube when the retaining restrictor 50 slides along the I-shaped guide rail 42 of the base member 16. The placement tube slides in the distal direction until the retaining limiting member 50 is adjacent to the stop member 44 on the rail 42, and at one point a predetermined portion of the retaining loop 26 is connected with the guide rail 42. The difference in the length of the cylindrical rod 38 will protrude beyond the distal end of a given placement tube 18. The extended portion remains straight and the remaining portion of the loop is still limited by the wall of the placement tube. The incontinence device mounting system described ensures proper orientation of the loop when the loop is extended to be inserted into the bladder. With the aid of an L-shaped hook, when the loop is inserted into the adjacent end of the tube, there is a lumen of the placement tube in the same direction.

Since the guide rail 42 has an upper flange notch at 56, when the retaining limiting member 50 reaches the stop 44, the contained urinary incontinence device and the guide tube are placed on the placement base member 16. It can be freely raised on the rail 42.

Next, a portion of the retention loop extending outwardly from the distal end of the placement tube is dipped with a sterile lubricating gel in contact with the kit, after which the user has a plunger 20 (FIG. 6) at the adjacent end 46. The distal end 58 of the head) is inserted into the lumen 48, and the protruding portion of the retention loop will be inserted into the urethral hole until the insertion restricting member 50 contacts the patient's vestibule. The insertion restricting member 50 is large enough to prevent the placement tube from passing through the urethral hole. As the finger rest 60 of the plunger 20 is compressed, the urinary incontinence device is placed through the urethra until the end 46 of the placement tube shown in FIG. 7 and the finger rest 60 of the plunger are adjacent. 18). The length of the plunger is carefully chosen so that when fully inserted the retaining loop is held in the bladder neck and can be extended to open the loop shape.

The batch base member, batch tube and push rod may be molded from preferred medical grade plastics such as ABS, but are not limited to these materials.

8 shows an alternative embodiment of the placement device of the invention. Here, the placement base member includes a single longitudinally extending rod 70 protruding from and attached to the finger grip member 72. The placement tube 74 fitted on the rod 70 has a stop member 76 at its distal end. The rod 70 is terminated in the hook 78, and when the stop 76 is adjacent to the base of the finger grip member 72, the rod end 70 of the placement tube 74 is closed. Extend outwardly. The urinary incontinence device of the type described above is also shown a retaining loop 26 formed annularly over the hook 78. The form shown in FIG. 8 is packaged in a sterile container with a hook 78 connecting the loop 26.

When removed from the sterile package by the user, the female grips the finger grip 72 between one hand and thumb as described above, and the placement tube 72 between the other hand and thumb described above, Back, the placement tube 74 slides to the right as shown in FIG. 8, and the retention loops 26 and stem 14 are pulled into the placement tube 74. When a portion of the loop approximately 15 mm long protrudes from the distal end of the placement tube, the indication of the device indicates that the user detaches the hook from the loop. As above, the protruding portions of the loop remain collapsed and remain straight. The lubricated tip of the retention loop is inserted into the urethral hole, and the placement tube is positioned so that the stop 76 is adjacent to the user's vestibule and submerged in the lubricant. The push rod as shown in FIG. 6 is used to move the urinary incontinence device away from the placement tube until the retention loop 26 is inserted into the bladder through the bladder and extended to open in the form of a loop.

The present invention provides those skilled in the art with the information necessary to use, configure and utilize the novel concept as required, and is described in detail herein to satisfy patent requirements. However, it is to be understood that the present invention may be practiced with various equivalents and apparatuses and various modifications, all of which may be accomplished without departing from the scope of the present invention. For example, a piece of string may consist of a placement base member in which the string loop penetrates the lumen of the placement tube and passes through the retention loop of the incontinence prevention device. Prior to placement, the urinary incontinence device will be pulled through the placement tube and a portion of the retention loop extending beyond the end of the placement tube as described above.

Claims (13)

A kit for treating tension incontinence in women, the kit comprising (a) a urinary incontinence device having a relatively flexible elastomer shaft comprising a bladder retention structure at the distal end of the urinary incontinence device and a vestibule connected to the retention structure at an adjacent end, (b) a disposition base member having a first shaft extending longitudinally from the finger grip and a finger grip at an adjacent end, the first shaft including an element at the distal end for connecting the device, (c) a placement tube for receiving the urinary incontinence device in the lumen just prior to placing the incontinence device into the urethra, the placement tube being slidable on the first shaft to assist in mounting the incontinence device into the lumen, (d) a plunger fitted within said lumen for discharging said urinary incontinence device from said placement tube into said urethra. The kit of claim 1 wherein the element comprises a hook. A kit for treating tension incontinence in women, the kit comprising (a) a urinary incontinence device having a relatively flexible elastomeric shaft comprising a closed loop bladder retention structure at the distal end, (b) a disposition base member having first and second shafts longitudinally protruding in parallel from the finger grip and having a finger grip at the proximal end, the first shaft including a hook element at the distal end, The second shaft has an abutment at its distal end, the second shaft is formed longer than the first shaft of a predetermined size, (c) a placement tube for receiving the urinary incontinence device in the lumen just prior to placing the urinary incontinence device into the urethra of the placement tube slidable on the first shaft to assist in mounting the incontinence device into the lumen, and (d) a plunger fitted within said lumen for discharging said urinary incontinence device from said placement tube into said urethra. 4. The kit according to claim 1 or 3, further comprising a sterile package for receiving said incontinence device, said placement base member, said placement tube and said plunger. 4. A kit according to claim 1 or 3, wherein the batch base member, the batch tube and the plunger are molded from medical grade plastic. In the sterilized kit used to treat neurological incontinence in women, the sterilized kit is (a) a urinary incontinence device having a relatively flexible elastomeric shaft comprising a bladder retention means at a distal end, (b) a placement tube having first and second ends for receiving an incontinence device in the lumen, and (c) a sterile member insertable through the first end of the placement tube to press the urinary incontinence device to be removed from the second end through the urethra of the patient. In the sterilized kit used to treat neurological incontinence in women, the sterilized kit is (a) a urinary incontinence device having a relatively flexible elastomeric shaft comprising a closed sac retaining loop at the distal end, (b) a placement tube having first and second ends for receiving the urinary incontinence device within the lumen immediately prior to placing the urinary incontinence device in the urethra of the patient, and (c) to draw the urinary incontinence device, the retention loop through the lumen and to the first end until a predetermined portion of the retention loop extends outwardly of the second end while sterilization is maintained; Means, and (d) a sterile member insertable through the first end of the placement tube to press the urinary incontinence device to be removed from the second end through the urethra of the patient. In the sterilized kit used to treat neurological incontinence in women, the sterilized kit is (a) a urinary incontinence device having a relatively flexible elastomeric shaft comprising a closed bladder retention means at a distal end, (b) a placement tube having a first and a second end for receiving an urinary incontinence device within the lumen, the placement tube including an insertion restricting member at the second end, and (c) a push member that is insertable through the first end of the placement tube to pressurize the urinary incontinence device to be removed from the second end through the urethra of the patient, wherein the insertion restriction member introduces the placement tube into the urethra; Sterilized kit, characterized in that it is prevented. A method for preparing a urinary incontinence device for placement inside a woman's urethra, the method comprising (a) providing a kit of claim 3 having a placement tube arranged around a first rigid shaft and a closed loop surrounding the hook element on the first rigid shaft, and (b) the placement tube away from the first rigid shaft while gripping the finger grip to be pulled into the lumen containing a predetermined portion of the closed loop bladder retention structure extending beyond the end of the placement tube. And a step of sliding. A method for inserting an urinary incontinence device in a woman's urethra, the method comprising (a) providing a kit of claim 6, (b) drawing the urinary incontinence device through the lumen to the first end of the placement tube such that a portion of the bladder retention means extends beyond the second end of the placement tube, (c) positioning the second end of the placement tube with respect to the urethral hole, and (d) advancing the push-up member through the lumen and the first end of the placement tube to push the urinary incontinence device over the urethra of the woman until the retaining means is arranged in the female bladder; Way. A sterilized kit for use in treating a urination disorder in a female, the sterilized kit includes a placement tube for placing and receiving an intraurethral device in the urethra of the woman, the placement tube passing through the urethral cavity A sterilized kit characterized by having an element at the distal end to prevent the placement tube from being inserted. 12. The sterilized kit of claim 11 further comprising a push member that is insertable into an adjacent end of the placement tube to advance the female urethral device over the urethra of the female patient. 13. The sterilized kit of claim 12 further comprising a device for mounting the female urethral device into a placement tube.

Images