JPH01285263A - Apparatus and method for obtaining urine incontinent capacity - Google Patents

Abstract

PURPOSE: To provide an inhibiting device for the incontinence of an urine of making possible to maintain a patient's inhibiting ability for the incontinence of the urine without any surgical operation by composing of that a globular membrane inserted in an urinary bladder and a strong magnetic material surrounding the above globular member as a coating is remotely controlled by a external magnet for positioning a regulated position in the bladder so that an urethral meatus is opened or shut by the globular membrane body in the bladder. CONSTITUTION: A globular body 10 includes a membrane made of a bio-compatible material and a strong magnetic material is held in the membrane or integrally formed with the wall portion of the globular body 10. The globular body 10 is transplanted into a bladder 14 through an urethral canal 12, and can give an inhibiting ability for inhibiting the incontinence of the urine by shutting a liquid flow between the bladder 14 together with the urethral meatus and the urethral canal 12. And the magnet 28 is positioned adjacent the bladder 14 on the outside of a patient's skin layer 34 and when the magnet 28 is operated to the strong magnetic material of the globular body 10, the globular body 10 is moved from the trigone of the bladder 26 and a crossing portion between the bladder 14 and the urethral canal 12 is released so that the urine can flow into the urethral canal 12 from the bladder 14.

Description

[Detailed description of the invention] [Field of industrial use] The present invention relates to a method and apparatus for controlling urinary incontinence.

BACKGROUND OF THE INVENTION Urinary incontinence is a very widespread problem in the United States and throughout the world. Urinary incontinence affects people of all ages, but is especially common among the elderly. It is estimated that close to one million Americans are candidates for surgical correction of urinary incontinence by means such as artificial urinary sphincter implantation.

Urinary incontinence has many causes including accident, disease or fetal defect.

Urinary incontinence is a potentially serious condition both physiologically and psychologically. For older children and adults, the loss of bladder control is a severe psychological shock. In patients who are otherwise frail, such as the elderly, urinary incontinence can also have a negative impact on the person's will to live. In such conditions, consideration of urinary incontinence, including the use of drugs such as urethane, may devastate a person's ego and self-image. As a result, there is a need to develop methods and devices that can effectively and efficiently control urinary incontinence to avoid the adverse impacts described above.

Urinary incontinence is also serious and undesirable for the patient's physical well-being. This condition requires surgery,
There are associated risks and hazards or the need to use catheters for the procedure. Both of these have potentially negative physical effects, including tissue damage and infection, as discussed below.

The urinary tract contains a series of elements. First, blood flows into the kidneys; here it is processed through the individual renal nephrons. Blood then exits the kidneys and returns to the general vascular system. Excess water, minerals and metabolite end products are removed from the blood as it passes through the kidneys. This part is collected and becomes urine.

Once urine is formed within the kidneys, it is excreted from the kidneys through the ureters. The ureters consist of tubes that connect the kidneys to the bladder. A pair of ureters, one from each kidney, drain urine into the bladder. Therefore, urine continues to flow from the kidneys through the ureters and into the bladder.

The bladder is essentially a storage container for urine. Urine is collected within the bladder until the bladder is relatively distended.

-Inside the shell, the adult bladder is approximately 0.47321 (approximately 1 pi
nt) of fluid. -When the bladder becomes full, it needs to be emptied. When such filling occurs, the interconnection between the bladder and urethra is opened by the organs described below, allowing urine to flow into the urethra.

The urethra carries urine out of the body.

The ability to control urinary incontinence is generally due to tonic contractions of smooth muscles located in the bladder neck. This muscular structure forms the so-called internal sphincter. Although not a true sphincter, the funnel-like passageway formed by this "vesical triangle" and the urethra effectively prevents urine from flowing during states of continence.

Although knowledge of the physiology of the bladder and urethra is incomplete, the ability to suppress evacuation is generally due to the internal sphincter. The juxtaposition of the tissue of the bladder trigone and the base of the urethra, which is not a true sphincter, forms the wallet-like portion of the bladder neck. A normally functioning bladder appears flat except during urination (urination). When some abdominal muscles, primarily the pubococcygeal muscles, relax, the bladder descends and the depressor muscles contract, forming a funnel-shaped opening in the bladder neck. Contraction of the abdominal cavity and tension of the bladder wall increases bladder pressure, causing urine to flow into the urethra.

Distension of the urethra creates a reflex that further increases bladder pressure. This feedback effect continues until the bladder is empty.

In most children older than 4 years, a higher brain center (formerly known as the gher brain center) controls the actual urination by holding the external sphincter closed after the urge to empty is felt. can be prevented. During the course of micturition, the cortical center (COrtiCalcenter)
) is neutral excitation
n) and relaxation of the urethra allowing the passage of urine.

If the external sphincter is not relaxed, the contractile compressor muscles can create enough pressure to cause tissue damage.

Urinary incontinence occurs when an individual is unable to control the course of muscle relaxation as described above. In individuals who are unable to control urinary incontinence,
Urine flows into the urethra regardless of any attempt by the individual to control urine flow.

Many types of devices have been developed to control urinary incontinence.

One type of these devices consists essentially of a cuff or similar structure surgically implanted around the outer wall of the urethra. If it is desired to prevent the flow of urine, the cuff is closed either hydraulically or mechanically so that it is tightly positioned around the urethra. Using this type of device, the urethra is physically closed by cuff pressure.

When emptying the bladder is desired, the external urethral cuff is retracted or relaxed to reopen the urethra. When this occurs, urine is freely released from the body through the urethra.

The method of operation of these cuff devices is in direct contrast to natural methods of preserving urinary incontinence control ability.

This natural method is independent of compressive forces around the exterior of the urethra and is to raise and lower the position of the bladder neck. As a result of the natural method of operation of these devices, cuff devices tend to cause severe tissue damage (tissue necrosis) and increased thickness and tension of the urethral wall (1).

This tissue damage makes it increasingly difficult for the cuff device to effectively close the urethra and reopen it when the pressure is relieved. Because of these problems, cuff devices can only be used for short periods of time before they experience significant difficulties in use. Furthermore, these VtI! may become trapped during implantation and may not function properly even after a relatively short period of time.

Contracting compressor muscles can also generate pressures high enough to damage tissue. In bladders capable of reflex contraction, artificial sphincters of the cuff type must be used with extreme caution. This is because increased vesicle pressure (1 nc
This is because maintaining the ability to suppress urinary incontinence in a state of (reased vesicle pressure) requires a tremendous compressive force around the urethra. The forces thus generated can cause significant tissue damage to the patient. In practice, the reflexive bladder
ladder) 1. In some cases, it is recommended to remove the nerve to the external sphincter muscle to prevent damage to the follicular tissue.

Methods and devices for physically constricting the urethra without the use of a full cuff have also been used. For example, one of these methods involves implanting a cylinder containing a magnet on one side of the urethra, outside of the urethra. This compresses the urethra by positioning the magnet at the distal end of the urethra outside the body. As a result, the implanted magnet is pressed against the outer wall of the urethra, theoretically constricting or narrowing the urethra sufficiently to retain its ability to control urinary incontinence. When it is desired to empty the bladder, the external magnet is removed and the force on vA31 is relaxed, thereby allowing urine to flow.

This type of device has drawbacks similar to those described with respect to the cuff. In particular, constant pressure against the urethral wall can cause significant tissue damage.

Additionally, implanted magnets may become trapped inside the body. Furthermore, it is difficult to obtain strong magnets that can effectively compress the urethra for long periods of time in the manner described for this device.

Another approach to urinary incontinence is to insert an inflatable bulb into the bladder through the urethra. A catheter is permanently attached to this pulp and extends through the urethra and out of the body. If urinary incontinence control capability is desired, the pulp is expanded by communicating with the external end of the catheter. When it is desired to empty the bladder, the valve is simply deflated to avoid occluding the bladder outlet.

There are some problems when using these types of devices. The most serious problem is that the catheter exiting the body provides a direct pathway into the bladder for infection. As a result, continuous antibiotic use is required when this type of device is deployed. Antibiotics also have seriously disabling side effects. As a result, this type of I!
! ! can only be used for a very short period of time and cannot be used as a long-term treatment method for urinary incontinence.

Other types of mechanical devices have been inserted through the urethra and into the base of the bladder. These devices are generally mechanically or electrically operated valves. However, these valves are rapidly skinned by body fluid components that come into contact with them. As a result, these valves typically fail within a short period of time.

Furthermore, permanent implantation of these valves within the urethra or bladder may lead to the disorders described above.

As a result of the various problems mentioned above, many existing devices used to control urinary incontinence are generally unusable, or even if they are, they can only be used for short periods of time. It has been found to be unusable. It has been found in this field that most devices involving implantation are prematurely removed due to the problems mentioned above. As a result, patients suffer repeated surgical scars without satisfactory cure for urinary incontinence. Therefore, it can be seen that at present there are no satisfactory methods and devices available for controlling urinary incontinence.

It is clear that what is needed in the art is a method and apparatus for preserving urinary incontinence control in individuals who normally lack the ability to control urinary incontinence. It would be a particularly significant advance in this field to provide a device that is simple, reliable, and retains its urinary incontinence control capabilities without mechanical or electrical failure when implanted in the body. . It would also be a further advance if such a device could be implanted and removed without surgery. It would also be a further advance in the art to provide a device that retains the ability to control urinary incontinence without significantly damaging the bladder, urethra, or surrounding tissue.

Furthermore, it would be an advance in this technical field to provide a method and device for maintaining urinary incontinence control ability that can maintain urinary incontinence control ability over a length W1m.

Such methods and apparatus are defined by the claims below.

[Problems to be Solved by the Invention] A general object of the present invention is to provide a method and apparatus for maintaining urinary incontinence control in individuals who lack the ability to control urinary incontinence.

It is an object of the present invention to provide an uncomplicated, yet reliable, urinary incontinence control capability that does not mechanically or electrically fail when implanted in a patient. i.

Another object of the present invention is to provide a method and placement for preserving urinary incontinence control II, II capacity in individuals without urinary incontinence control capacity, such that it can be implanted and removed without surgery. That's true.

An additional object of the present invention is to provide a method and apparatus for maintaining urinary incontinence control in individuals who are incapable of urinary incontinence control without causing significant tissue damage.

Yet another object of the present invention is to provide a method and apparatus for maintaining urinary incontinence control in an incontinent individual that can be manipulated and controlled by the patient.

[Means and effects for solving the vI problem] The present invention provides a method for maintaining urinary incontinence control ability and a WA system for individuals who do not have urinary incontinence control ability III as limited in the scope of the claims. . In essence, the invention involves the non-surgical implantation of a bolus of ferromagnetic material within the bladder. The ferromagnetic material can be incorporated within the biocooperative membrane, can be integral with such a membrane, or can constitute the entire sphere.

A spherical body containing ferromagnetic material is usually placed between the bladder and urethra.
Inside the shell is a ``trione reaio''.
nor bladder), or bladder neck
It is held stationary at a junction called the der neck, blocking the flow of urine from the bladder to the urethra.

In an alternative embodiment, the sphere is held in place by an external magnet.

Thus, in this statically held position within the bladder trigone, the bulb retains its ability to control urinary incontinence. In effect, this sphere serves as a simple, yet effective seal between the urethra and the bladder. With the bladder neck forming the seat of the bulb,
The bulb forms an effective valve at the intersection between the bladder and urethra.

When it is desired to empty the bladder, the bulb containing the ferromagnetic material is moved away from the intersection between the bladder and the urethra. This is accomplished by positioning a magnet along the exterior of the patient's body and manipulating the magnet until the sphere is moved to the desired position. Movement of the magnet is sufficient to displace the bulb so that urine begins to flow from the bladder into the urethra.

One preferred embodiment of the invention includes forming a membrane with biocompatible materials. Such biocompatible materials are, for example, of medical quality (g+adica
It can be made of polyurethane or polytetrafluoroethylene (trade name Teflon). The collapsed membrane is then non-surgically inserted through the patient's urethra and into the bladder. - Once the membrane is positioned in place within the bladder, a ferromagnetic material, usually a liquid, is filled into the membrane.

As mentioned above, other embodiments of the invention can provide the same results. For example, the membrane itself can be formed from a ferromagnetic material and filled with water, salt, or other similar liquid. Alternatively, the spheres can consist of spheres of ferromagnetic solid or ferromagnetic gel. The results show that there is a wide range of possibilities for producing spheres with the required ferromagnetic properties.

One method of implanting a sphere, particularly when the outside of the sphere includes a membrane, involves placing an empty membrane inside a hollow catheter. The membrane is also placed in communication with a tube or other similar structure disposed within the hollow catheter. The needle also passes through the interior of the deployment catheter.
er). The deployment catheter is external to the patient and connected to a needle body that includes a chamber that holds a ferrofluid.

- When the Caticil is inserted into the bladder through the urethra and communicates with the interior of the bladder, the ferromagnetic material is injected into the membrane by the deployment catheter.

- Once the membrane contains a sufficient amount of ferromagnetic material, a needle or other similar injection device is withdrawn from the membrane to hold it in a sealed state filled with ferromagnetic fluid. In a variant, the injected fluid need not be ferromagnetic if the membrane itself is ferromagnetic.

- Once the membrane is properly sealed, the catheter is removed from the patient. The end result of these procedures is thus a membrane containing a ferromagnetic material, or a ferromagnetic membrane containing a fluid, which can be placed inside the bladder without surgery. In the case of gel spheres, the spheres can be inserted using a similar catheter mechanism. The solid sphere can be made of epoxy resin formed in situ within the bladder. The position of the sphere within the bladder can be controlled by the force exerted on the ferromagnetic sphere by a magnetic field external to the patient's body.

The bulb generally rests over the opening between the bladder and urethra when the individual is in an upright position.

That is, the bulb is generally located within the bladder triangle and within the bladder neck. In this common arrangement, the bulb seals against the bladder neck, obstructing the flow of urine from the bladder into the urethra. When it is desired to empty the bladder, the magnet can be moved so that the device is displaced from the bladder trigone to allow flow from the bladder into the urethra.

Embodiments A. A preferred embodiment of the present invention provides a method and apparatus for retaining urinary incontinence control in an incontinent individual that can be operated and controlled by a patient wearing the device. These and other objects will become apparent from the detailed description set forth below in conjunction with the accompanying drawings.

The present invention will be best understood with reference to the drawings, in which like parts are numbered similarly. The invention and its overall operation will be understood with reference to FIG. 1st
The figure shows the anatomical extent of the lower half of the torso. especially,
FIG. 1 shows the urethra 12 and bladder 14.

Also shown in FIG. 1 is a spherical body 1o according to the invention held stationary 1 in place inside the bladder 14. In one embodiment of the invention, the spherule includes a membrane bedded with a biocompatible material.

One such biocompatible material is medical grade polyurethane, but it has been discovered that other types of materials are also possible, such as the aforementioned Teflon. Preferably, the material forming the sphere 10 is biocompatible, non-toxic, and non-lithogenic (non-1 order hOgOniC).

The sphere 10 contains a quantity of ferromagnetic material.

The ferromagnetic material can be held stationary within the membrane or integrally formed with the wall of the sphere.

In practice, ferromagnetic materials can be made into solids or gels;
Moreover, the entire spherical body can be constructed.

If the ferromagnetic material is contained within the membrane, it is preferably in the form of a liquid. However, other materials can also be used.

Various types of ferromagnetic liquids are available. Such liquids may be hydrocarbon-based or aqueous-based. One such ferromagnetic liquid is a 900 Gauss saturated iron composite fluid manufactured by Ferrofluidics Inc.
on ferrofluid). Such fluids are non-toxic, biocompatible, chemically stable, and
It is desirable to have high magnetic permeability and saturation properties.

As shown in FIG. 1, sphere 10 is implanted inside bladder 14. The method of transplantation will be described in further detail below.

When in position, bulb 10 is held against the interconnection between urethra 12 and bladder 14. This general area is often referred to as the bladder neck or bladder triangle. Closing this portion of the bladder triangle causes collection of urine within the bladder. As a result, the bulb 1o contains, together with the bladder neck, a substantially simple but effective valve for occluding fluid flow between the bladder 14 and the urethra 12. In particular, the spheroid 10 is useful for providing urinary incontinence control to individuals who do not normally have urinary incontinence control.

In order for the sphere 10 to form a proper seal, it is important that the sphere is formed from a flexible, pliable material. This allows the bulb to conform to the inner wall of the bladder, effectively blocking fluid flow. Similarly, if the sphere 1o is a membrane, it is important that the membrane is not filled with fluid to the point where it becomes inflated or inflated.

Sphere 10 can be manufactured by any acceptable and desirable method. In effect, all that is required is to form a continuous outer surface of spherical or other desired shape. For most purposes, a shape that allows for displacement and deflection within the bladder facilitates actuation of the device, allowing the bulb 10 to be moved by the various fluid components within the bladder and urethra.
It is desirable to minimize the entrapment effects of

One method of producing continuous spheres in the form of such films is to first provide ice spheres of the desired shape and dimensions. The ice sphere is then immersed into the polymer solution. One such acceptable polymer is medical grade polyurethane dissolved in methylene chloride. - Once the polishing water spheres are fully coated with the polymeric plastic material,
Removed and frozen II! The Φ compound is then transported to the pores, where it is allowed to dry. Such dipping and drying steps can be repeated as many times as necessary to obtain a membrane of desired thickness. - Once the solution has been sufficiently evaporated from the polymer, the ice trapped within the resulting polymer film will melt and can be removed by a small hypodermic needle or similar other method. .

Alternatively, the membrane can be cast and coated onto an appropriately shaped conventional mandrel.

Once the mandrel is sufficiently coated, the membrane can be removed by essentially turning it inside out. Another variant manufacturing method is blow moulding.
olding), spray coating (5praycoatr+
ng), resin casting and injection molding.

As mentioned above, spheres 10 can also include spherical gels or spherical solids. Such a gel can be inserted into the bladder and operated in a manner similar to that described above. If the sphere is a solid, the solid can be an epoxy resin that is naturally formed within the bladder.

B. Use of the Preferred Embodiment The use of the spherical body 1o can be clearly understood with reference to FIGS. 2 to 5. Figure 2 shows ￥A bladder 14 and kidney (not shown) to bladder I! The ureter 30 is shown being guided into the ureter 14. Descending from the base of the bladder 14 is the urethra 12 . Additionally, FIG. 2 generally shows the bladder triangle 26 of the bladder 14.
and prostate gland.

Spheroid 10 as a seal between bladder 14 and urethra 12
The operation of this can be fully understood with reference to FIGS. 4 and 5. Fourth
In the figure, bulb 10 is shown in place at the base of bladder 140. In particular, the bulb 10 completely covers the intersection between the bladder 14 and the urethra 12 at the bladder trigone 26.

Thus, in FIG. 4, it can be seen that as long as the bulb 10 remains at the base of the bladder 14, urine flowing into the bladder 14 through the ureter 30 will be collected within the bladder 14. FIG. 4 shows the bladder 14 while relatively distended and filled with collected urine.

To empty the bladder 14, the bulb 10 must be removed away from the intersection between the bladder 14 and the urethra 12, ie, the bladder neck or trigone. As previously mentioned, this is accomplished by positioning the magnet on the patient's skin, generally proximate to the bladder 14. Figure 5 shows bladder 1
The magnet 28 is shown positioned outside the patient's skin layer 34 in direct vicinity of the magnet 4 . It can be seen that the magnet 28 attracts the spherical body 10.

It is recognized that a sufficiently strong magnet is required to facilitate the operation of the present invention. One such magnet is the 25°ooo,ooo Gauss-Oersted neodymium-iron-boron magnet (25-illi
on Gauss-Ocrsted neodyllLll
-1ron-boron magnet). This magnet works well when the 900 described above is combined with a saturated iron-containing fluid. A suitable magnet preferably has the characteristics of being lightweight, moldable, and having a large magnetic field strength.

As a result of the action of the magnet 28 on the ferromagnetic material within or consisting of the sphere 10, the sphere 10 is displaced from the bladder triangle 26 of the bladder 14 and into the bladder 14 and urethra 12.
The intersection between is released.

In this position, urine can flow from the bladder into the urethra 12. This condition 8 is fully shown in FIG.
It is desirable to continue until the number 4 is completely empty.

When the bladder [t14 is emptied, the spherical body 1o returns to the bladder triangle 2
6 and urine begins to accumulate in the bladder 14 again. By simply separating the magnet 28 from this position, the spherical body 10
is sufficient to lower the object into a position under the action of gravity. In a variation, the magnet 28 may be caused to move downwardly along the patient's skin until the membrane of the bulb 10 is again seated at the intersection between the bladder 14 and the urethra 12.

Method and Apparatus for C1 Implantation One advantage of the present invention is that bulbous point 10 can be inserted and removed non-surgically. The figures illustrate one method of such non-surgical spherule implantation, particularly when the spherules include a membrane or gel material. In Figure 2, a urethral insertion catheter (urin) is shown.
ary 1nsertioncatheter) 36
is shown moving upward through the urethra 12. The top of the catheter 36 is approximately connected to the urethra 12 and the bladder 14.
It is located at the intersection between The membrane 11 is loaded inside the insertion catheter 36 . However, it is understood that similar insertion methods can be used to insert gel spheres. The method of loading membrane 11 into insertion catheter 36 is described in detail below.

Once the cachicil 36 has protruded through the bladder trigone 26 and into the interior of the bladder 14, the vAll is deployed into position within the bladder 14. Figure 3 shows II! deployed in the bladder and filled with suitable material! J11 is shown.

This can be a ferromagnetic fluid, but in the case of ferromagnetic films the fluid can be non-ferromagnetic.

One embodiment of an insertion device or catheter 32 is understood with reference to FIG. The overall catheter 32 is an insertion catheter 3
Contains 6. The insertion catheter 36 can be, for example, a conventional catheter used in urological medicine.

Insertion catheter 36 is also secured to a needle body 38 or other similar device that performs the same overall operation. Needle body 38 includes a plunger ram 40 extending therethrough. A storage tank 42 is arranged inside the injection needle body 38. It will be appreciated that prior to use, reservoir 4!42 is filled with a suitable amount of ferrofluid or other suitable fluid that is injected into the interior of membrane 11 when 11111 is deployed inside bladder 14.

Inside the insertion catheter 36 is a deployment catheter (dep).
A loyment catheter (loyment catheter) 44 is arranged.

Deployment catheter 44 passes through insertion catheter 36 and terminates at a proximal end within reservoir 42 of needle body 38 . Deployment catheter 44 terminates at 11111 at its distal end. The distal end of deployment catheter 44 is shaped like a needle or other injection device for introducing fluid into model 11.

The deployment catheter 44 includes a female deployment latch latch 46 at its proximal end.

Similarly, plunger ram 40 extending within needle body 38 includes a male deployment latch 47 that corresponds to a female deployment latch 46 attached to deployment catheter 44. As a result, when the plunger ram 40 reaches the end of the iron-containing chamber, the male deployment latch 47 of the plunger ram 40 engages the female deployment latch 46 of the deployment catheter 44. Deployment catheter 44 is a plunger.
Once secured to ram 40, plunger ram 40 is retracted slightly when deployment catheter 44 contacts distal base 58 of the catheter mechanism or other similar structure within the distal end of deployment catheter 44. Membrane 11 becomes pushed away from the end of deployment catheter 44.

Figure 6 shows the deployment m! lJ location 48 is shown.

This arrangement a glide cavity 48 is essentially the insertion catheter 3.
6 and a reservoir 42 within the deployment catheter 44. Thus, deployment catheter 44 can move relatively freely within this deployment glide cavity 48 and extend beyond the end of insertion catheter 36 while deploying membrane 11 into position.

At the distal end of insertion catheter 36, membrane 11 is encased within catheter 36. The distal end of deployment catheter 44 is adapted to communicate with the interior of membrane 11 through septum 50 of membrane 11 if membrane 11 is constructed to include septum 50 .

The structure of the distal end of insertion catheter 36 and the structure of membrane 11 can be better seen with reference to FIG. The distal end of insertion catheter 36 is shown in FIG. A deployment catheter 44 is disposed within the insertion catheter 36 .

Also, in FIG. 7, the distance between the membranes 11 is g! 50 is shown. Membrane 1
1 can be shaped such that a slightly enlarged partition wall 50 is placed on one side of 1111.

An opening 52 is provided through the wall of the membrane 11. This opening 52 can be shaped to substantially include a female joint. At the same time, the distal end of deployment catheter 44 can be shaped to include a male isolation plug 56. This separation plug 56 also includes a filling boat 54 through which it can be introduced into the interior of the fluid receptacle 11.

The general method of operation of catheter mechanism 32 can be understood with reference to FIGS. 6 and 7. For details, see Figures 2 and 3.
The distal end of the insertion catheter 36 is inserted through the patient's urine 3i12 and into the trigone of the bladder 14 as shown. - When the top of the insertion chamber 36 reaches the inside of the bladder 14, the plunger ram 40 is depressed. This allows deployment catheter 44, including reservoir eff 42 and plunger ram 40, to slide within deployment slide cavity 48. The membrane 11 is thus pushed out of the vA section of the insertion catheter 36 and into the bladder by the distal base 58 of the catheter.

When the reservoir 42 contacts the base 60 of the insertion catheter 36, the latches 62 are directed outwardly by the tabs 64 to release the plunger ram 40 and allow it to move within the reservoir 42. Fluid contained within reservoir 42 is thereby forced through the interior of deployment catheter 44 by plunger ram 40. Fluid flows through the interior of deployment catheter 44 and through a fill boat 54 located at the distal end of deployment catheter 44.

Once the entire contents of reservoir 42 have been pushed through the interior of deployment catheter 44 and into membrane 11, plunger
A male deployment latch 47 at the end of the ram 40 fits within a female deployment latch 46 at the proximal end of the cage IIh tee 44. At this point, membrane 11Lt is properly filled with fluid. Alternatively, the membrane itself can be made ferromagnetic, and such a membrane can be filled with a non-ferromagnetic fluid.

In a third embodiment, ferromagnetic gel spheres can be inserted in a similar manner.

Once membrane 11 is filled with fluid and plunger ram 40 is securely locked within deployment latch 46, catheter mechanism 32 is ready to be removed from within bladder 14. Plunger ram 40 can thus be withdrawn such that isolation plug 56 at the distal end of deployment catheter 44 fits within opening 52 in septum 50. The opening 52 is therefore sealed. As deployment catheter 44 is pulled further away from membrane 11, the separation plug is effectively pulled away from the end of catheter 44.

Further withdrawal of the plunger ram 40 causes the membrane 11 to be deployed within the bladder 14 as the Wi 411 contacts the distal base 58 and the deployment catheter 44 continues to be withdrawn by the pulling action on the plunger ram 40. At this point, the entire catheter system 32 is withdrawn from inside the urethra 12 and Il! 11 may be left in place within the bladder 14.

As a variation of the use of isolation plug 56 and opening 52,
Simply place the needle at the end of the deployment force
It is also possible to enter fl wall 5 wall 0.

In this case the needle is used to fill the membrane 11 and can be removed in much the same manner as described above. Above) Like wood, the septum of the membrane 11 is constructed to be thick enough to seal the interior of the crotch 11 when the needle is removed.

This entire procedure can be performed using ultrasonic imaging, optical cystoscopy or fluoroscopy, so that the position of the various elements can be constantly monitored and the sphere 10 Bladder T
It is correctly placed inside the IC14. This procedure, when combined with imaging techniques, avoids the need for surgery to correct inability to control urinary incontinence.

The need for surgery to implement existing treatments for the inability to control urinary incontinence has been a major limitation to their use and effectiveness.

Because implanted materials, such as membrane 11, tend to become trapped by body fluid components, it is necessary to equilibrate the material within membrane 11 with the fluid outside membrane 11, thereby creating an osmotic pressure gradient that causes the material to become trapped in membrane 11. It is desirable to form a sphere that does not become trapped in the walls of the tube.

It is also necessary to periodically remove the sphere 10 from the bladder and replace it with a new sphere due to loss of performance, leakage, encrustation, infection or other physiological factors. The membrane 11 can be easily taken out. If the bulb 10 is a membrane, the attachment of a needle or forceps-like stick may be as simple as inserting a urinary catheter with the device.

This pierces the bulb 10 and allows the fluid inside the bulb 10 to escape into the bladder.

Fluid immediately flows out of the urethra 12. At the same time, 10 spherical bodies
is secured to a catheter and can be drawn through the interior of the urethra 12 and out of the patient.

This also applies when gel spheres are used.

In the case of solid spheres, it is necessary to crush the spheres so that they can be easily removed from the bladder.

In this way, the spherical body 10 can be easily removed and replaced with a new spherical body, if necessary. Since neither removal nor replacement requires surgery in this case, these procedures are relatively psychologically and otherwise harmless to the patient.

D. Tests were conducted on intact dogs to check the operation of the animal testing device. The 15Kg giant was anesthetized and placed on his back. The dog was anesthetized to facilitate the testing procedure. In this condition, the bladder neck was positioned slightly downward rather than slightly upward as when the dog is in the upright normal position. A sphere in the form of a membrane containing a ferrofluid was successfully inserted using the insertion procedure described above.

The membrane was filled with a kerosene hydrocarbon based ferrofluid and released from the catheter by the method described above.

The entire procedure was visualized by fluoroscopy to confirm correct positioning of the membrane.

This test showed that the method of inserting the membrane was very satisfactory and the membrane within the bladder was easily manipulated using an external magnet. At the end of the study, the dog appeared to be in good condition and appeared capable of controlling urinary incontinence.

After about 8 days, the membrane was destroyed. Examination of the surface of the bladder mucosa showed slight inflammation due to placement.

In an additional test, a condition resembling incontinence was induced in dogs capable of controlling urinary incontinence by inserting an open-ended catheter deep enough into the urethra to pierce the internal sphincter of the trigone of the bladder. occured. However, the catheter was not inserted deep enough into the bladder to prevent the membrane seal from seating in the bladder neck. It was determined that by careful manipulation of the membrane, the membrane sphere within the bladder could be stopped and started by an external magnet to empty the bladder.

The membrane sphere was left in the cavity for 6 days, after which non-surgical removal of the membrane was performed. It was determined that the membrane could be emptied by holding it stationary with an external magnet and clamping the membrane with flexible alligator forceps inserted through the cystoscope. Saline was then flushed out of the bladder and the micro-contracted membrane bag was captured and removed. Cystoscopy of the surface of the bladder mucosa and the membrane itself did not reveal anything remarkable.

The mucosa was not inflamed and the membrane was intact.

Therefore, it can be seen that the method and apparatus of the present invention performed well under the test set-up conditions. Actual urinary incontinence control capacity was obtained for animals given a urinary incontinence control deficiency. Similarly, insertion and removal of the membrane was relatively easy. It can therefore be seen that the method and apparatus of the present invention can accomplish each of the above objectives without actually requiring surgery.

[Summary 1] To summarize the foregoing, the present invention provides methods and devices for maintaining urinary incontinence control in individuals who lack the ability to control urinary incontinence. This is done non-surgically by inserting a ferromagnetic sphere into the bladder of such an individual.

The sphere can be constructed of ferromagnetic material, or a ferromagnetic fluid can be used to fill the sphere. The bulb is then manipulated by an external magnet to control the flow of urine through the bladder. In particular, a magnet can be used to hold the bulb in place at the intersection between the urethra and the bladder. Alternatively, an external magnet can be used to separate the bulb from the bladder trigone and initiate urine flow. All these operations can be easily performed directly by the patient. Accordingly, the present invention allows correction of urinary incontinence control deficiencies using inexpensive materials and devices without the need for surgery.

The invention may be embodied in other forms without departing from its spirit or essential characteristics. The embodiments described above are in all respects merely illustrative and must not be considered as limiting the invention. It is therefore intended that the scope of the invention be limited not by this detailed description, but rather by the claims appended hereto. All changes that come within the scope of the claims and their range of equivalents are intended to be embraced broadly therein.

[Effects of the Invention] Since the present invention is configured as described above, it provides a method and device for allowing an individual who does not have the ability to control urinary incontinence to maintain the ability to control urinary incontinence without actually requiring surgery. ,
It can be performed without the need for surgery, and the insertion and removal of the membrane sphere is easy. The sphere can be constructed of ferromagnetic material, or a ferromagnetic fluid can be used to fill the sphere. The sphere is manipulated by an external magnet to direct the flow of urine through the bladder.
, +1111, and in particular magnets can be used to hold the bulb in place at the intersection between the urethra and the bladder.

An external magnet can also be used to separate the bulb from the bladder trigone and initiate urine flow. All these operations can be easily performed directly by the patient. In this way, the present invention can exhibit excellent effects.

[Brief explanation of the drawing]

FIG. 1 is a schematic cross-sectional view of the lower half of the torso showing the spherical body of the present invention inserted into the bladder. FIG. 2 is a schematic cross-sectional view of the bladder and urethra showing a catheter partially inserted into the urethra. FIG. 3 is a schematic cross-sectional view of the bladder and urethra showing the catheter in the step of inserting the spherical body into the bladder. Figure 4 shows the intersection between the bladder and urethra. FIG. 1 is a schematic cross-sectional view of the bladder and urethra showing the obstructing bulb and the urine-filled bladder. FIG. 5 is a schematic cross-sectional view of the bladder and urethra, showing a state in which the spherical body moved by the magnet and urine are flowing into the urethra. FIG. 6 is a cross-sectional view of one embodiment of an insertion catheter mechanism. FIG. 7 is a cross-sectional view of one embodiment of a septum portion of a membrane inserted into the end of an insertion catheter. 10... Spheroid 11... Membrane 12... Urethra 14... Bladder 24... ..... Prostate 26 ..... Bladder triangle 28 ..... Magnet 30 ..... Ureter 32 .....・Catheter mechanism 36...
...Insertion catheter 38...Injection needle body 40...Plunger ram 42...
...Storage tank 44...Deployment catheter 46...
...Female deployment latch 47...Male deployment latch 48...Deployment sliding space 50...Bulkhead 52... ......Opening 54......Filling boat 56...Male separation plug 60...Base 62... ...Latch 64...Tab

Claims (31)

[Claims] (1) In a device that maintains the ability to suppress urinary incontinence in a patient who does not have the ability to suppress urinary incontinence, the device is placed in the bladder of the patient who is incapable of controlling urinary incontinence, is seated within the range of the bladder triangle, and is capable of directing urine into the urethra. a ferromagnetic sphere adapted to prevent inflow; and a restraint operable to magnetically move the position of the sphere within the bladder away from the bladder trigone to permit inflow of urine into the urethra. Devices external to the incapacitated patient's body and devices containing. (2) The device for maintaining the ability to suppress urinary incontinence according to claim 1, wherein the spherical body includes a flexible membrane containing a ferromagnetic fluid. (3) The device for maintaining the ability to suppress urinary incontinence according to claim 1, wherein the spherical body includes a ferromagnetic film containing fluid. (4) Claim 1, wherein the spherical body contains a ferromagnetic gel.
A device that retains the ability to suppress urinary incontinence as described. (5) Claim 1, wherein the spherical body contains a ferromagnetic solid.
A device that retains the ability to suppress urinary incontinence as described. (6) The device for maintaining the ability to suppress urinary incontinence according to claim 1, wherein the device for magnetically manipulating the position of the spherical body includes a magnet. (7) The device for retaining the ability to suppress urinary incontinence according to claim 2, wherein the control is made of a biocompatible material. (8) The device for maintaining the ability to suppress urinary incontinence according to claim 2, wherein the membrane is made of polyurethane. (9) Claim 2, wherein the ferromagnetic material is a hydrocarbon substrate.
A device that retains the ability to suppress urinary incontinence as described. (10) The device for maintaining the ability to suppress urinary incontinence according to claim 2, wherein the ferromagnetic material is an aqueous base. 11. The urinary incontinence of claim 2, wherein the permeability and amount of ferromagnetic material of the membrane are selected to approximately balance fluid pressures inside and outside the membrane when the membrane is in the bladder. A device that maintains suppression ability. (12) The device for retaining urinary incontinence control ability according to claim 2, wherein the membrane further includes a sealing device for sealing the fluid inside the membrane after the fluid is introduced into the membrane. (13) Claim 12, wherein the sealing device includes a diaphragm.
A device that retains the ability to suppress urinary incontinence as described. (14) A flexible, biocompatible, ferromagnetic spherical body placed within the bladder, said spherical body capable of conforming to the confines of the bladder trigone at the opening of the urethra, and said spherical body capable of being used. A valve that maintains the ability to suppress urinary incontinence, which can be selectively moved within the bladder by a magnet located outside the person's body. (15) The specific gravity of the spherical body is greater than the specific gravity of urine,
15. Urinary incontinence control according to claim 14, wherein when the user is in an upright position, the spherical body is brought into a sealed position by gravity within the bladder triangle at the intersection within the urethra. A valve that retains its capacity. (16) The valve retaining the ability to suppress urinary incontinence according to claim 14, wherein the spherical body is arranged in a sealed position within the bladder trigone by a magnetic force acting on the spherical body. (17) The valve retaining the ability to suppress urinary incontinence according to claim 14, wherein the spherical body includes a flexible membrane containing a ferromagnetic fluid. (18) The device for maintaining the ability to suppress urinary incontinence according to claim 14, wherein the spherical body includes a flexible ferromagnetic film containing fluid. (19) The device for maintaining the ability to suppress urinary incontinence according to claim 14, wherein the spherical body contains a ferromagnetic gel. (20) The device for maintaining the ability to suppress urinary incontinence according to claim 14, wherein the spherical body contains a ferromagnetic solid. (21) The spherical body has a thickened diaphragm portion on its wall, and includes a membrane adapted to be pierced by a needle and filled with a ferromagnetic material therein, and when the needle is pulled. 15. The urinary incontinence control valve of claim 14, wherein the septum is adapted to reseal the membrane and retain the ferromagnetic material within the membrane when withdrawn. (22) A method for controlling urinary incontinence comprising: (a) providing a closed membrane; (b) inserting said membrane into the bladder through the urethra of an incapacitated individual; and (c) inserting said membrane into said membrane. (d) sealing the membrane to minimize flow into and out of the membrane; (e) manipulating the membrane and the position of the ferromagnetic material therein; A method that involves using a magnet external to the body of an incapacitated individual to open and close the opening of the urethra to the bladder. 23. The method of controlling urinary incontinence of claim 22, wherein the step of inserting the membrane through the urethra comprises: (i) having a needle body having a plunger ram and an iron-containing chamber at one end; further providing a catheter having an insertion catheter at a distal end, a device for retaining a membrane within said distal end, and a device for pushing said membrane outwardly from said end; (ii) said membrane; (iii) inserting the distal end of the catheter into the bladder through a discrete urethra. (24) A method for controlling urinary incontinence according to claim 23, wherein the step of introducing the ferromagnetic fluid into the membrane comprises: (i) filling the iron-containing chamber with a predetermined amount of the ferromagnetic fluid. (ii) communicating the distal end of the insertion catheter with the interior of the membrane; and (iii) sliding the plunger ram into the iron-containing chamber so that the ferrofluid passes through the insertion catheter and into the membrane. A method comprising transferring into the interior of a membrane. 25. The method of claim 24, further comprising the step of pressing the membrane from the end of the insertion catheter so that the membrane is deployed in place within the bladder. 26. The method of controlling urinary incontinence according to claim 25, further comprising the step of removing the catheter from the urethra. (27) A method for controlling urinary incontinence comprising: (a) providing a closed ferromagnetic membrane; (b) inserting said membrane into the bladder through a non-inhibiting individual urethra; and (c) said (d) sealing said membrane to minimize flow into and out of said membrane; (e) using a magnet external to said non-restrained individual's body; manipulating the position of the membrane and the ferromagnetic material therein to open and close the opening of the urethra to the bladder. (28) A method for controlling urinary incontinence, comprising: (a) providing a ferromagnetic spherical body; (b) inserting the spherical body into the bladder through a discrete urethra having no restraint ability; and (c) restraining the body. A method comprising the steps of manipulating the position of the bulb to open and close the opening of the urethra to the bladder using a magnet external to the incapacitated individual's body. (29) The method for controlling urinary incontinence according to claim 28, wherein the spherical body contains a ferromagnetic gel. (30) The method for controlling urinary incontinence according to claim 28, wherein the spherical body includes a ferromagnetic solid. (31) The method of controlling urinary incontinence according to claim 30, wherein the ferromagnetic solid is an intravesical solid.