WO2002028469A1

WO2002028469A1 - Uterine balloon catheter

Info

Publication number: WO2002028469A1
Application number: PCT/US2001/016484
Authority: WO
Inventors: Mohiuddin M. Muzzammel
Original assignee: Muzzammel Mohiuddin M
Priority date: 2000-10-05
Filing date: 2001-06-21
Publication date: 2002-04-11
Also published as: AU2001269696A1

Abstract

A balloon catheter used in the uterus of a patient. A tubular member (5) with a hollow interior (6) is used to transport pressurized fluid to or from a balloon (1) fixed to the tubular member. A self sealing valve (13) is located adjacent one end of the tubular member. The balloon catheter can be used for short term periods or long term contraceptive benefits and may have other uses.

Description

Uterine Balloon Catheter

BACKGROUND OF THE INVENTION

This invention relates to an intrauterine catheter having a balloon that is both inflatable and deflateable while in place.

Medical devices that are used in the uterine cavity to perform clinical procedures on a patient are known. Usually the in place duration of such device is very limited. When in use pressure is created on the lining of the uterus. Depending on the degree of the created pressure, the growth of the endometrium or bleeding from endometrium can be reduced or totally stopped. Most of these mechanical pressure methods have not been very successful and their use has been very limited in the past due to poor results. Mechanical pressure on the endometrial lining can also have other uses, which include contraception. At the present time such uterine contraceptive devices have various side effects, which include menorrhagia, dysmenorrhea and increased sepsis.

The present invention seeks to minimize or prevent uterine bleeding depending on the pressure used. Side effects such as dysmenorrhea and sepsis are also expected to be less frequent than intrauterine contraceptive devices. Additionally, the time frame the balloon device may be left in place in the uterus can be greatly increased to decrease bleeding from endometrium associated with fibroids, adenomyosis and other endometrial pathology such as endometrial polyps and endometrial hyperplasia.

A balloon device can also be used in postpartum hemorrhaging. Using a large balloon pressure to accommodate the postpartum uterus has several clinical advantages. Postpartum bleeding can be associated with uterine atony or any form of coagulopathy or the retained segment of a placenta or a membrane. To counter these effects, the inserted balloon pressure device much have a large volume.

DESCRIPTION OF THE PRIOR ART

Medical devices that can be inserted into the uterus of a patient to perform clinical procedures are known in the prior art. For example, U.S. Patent 3,875,939 to Boϊduc et al discloses a device used to place a drug in the uterine cavity and comprises a probe with an expanding sleeve.

U.S. Patent 4,349,033 to Eden discloses a uterine balloon catheter which has an inflatable balloon attached to a catheter segment with the catheter segment having a valve at one end to inflate or deflate the balloon.

U.S. Patent 5,078,725 to Enderie et al discloses a balloon catheter device that has a specially shaped balloon which, when inflated, is shaped as a cone.

U.S. Patent 5,935,098 to Bialadell et aϊ discloses a catheter system which has an inner catheter having a sleeve disposed over the inner catheter and with the inner catheter having a balloon disposed adjacent one end.

In the present invention a uterine balloon catheter is used to place pressure on the uterus of a patient. At the end of the device opposite the the inflatable balloon is a self sealing material which is penetrated by a pressure regulating device to increase or decrease the internal balloon pressure. The self sealing end valve is within and substantially coextensive with the inner diameter of the tubing used to support the balloon and transfer fluid to the balloon, all as will be detailed in the specification that follows hereafter.

SUMMARY OE THE INVENTION

This invention relates to a uterine balloon catheter used to place pressure on the lining of the uterus of a patient. At the cervix end of the device is a self sealing valve which can be penetrated to introduce or remove pressure which causes fluid to fill a balloon within the uterus. This valve is located within the end of the tubing used to transport fluid from or into the balloon, and is usually located at the end near the cervix.

It is the primary object of the present invention to provide for an improved inflatable balloon uterine catheter device.

Another object is to provide for such a device in which an end of the device has a self sealing valve within the tubing used to transport fluid from and away from the balloon.

These and other objects and advantages of the present invention will become apparent to readers from a consideration of the ensuing description and the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a side view of the present invention with its balloon partially inflated and a typical fluid insertion needle.

FIG. 2 is a side view of the present invention used in FIG. 1 while the balloon is in a deflated state.

FIG. 3 schematically shows the inflated balloon catheter inserted into the uterus of a patient.

FIG. 4 is an end view of the tubing showing the self sealing valve.

DESCRIPTION OF THE PREFERRED EMBODIMENT FIG. 1 is a side view of the present invention with its balloon 1 partially inflated and a conventional fluid insertion needle 3. The balloon 1 is shown as made of a clear or transparent material to permit the viewing of the interior. Extending into the balloon 1 is a tubular member 5. Tubular member 5 is a straight, elongated member that has a hollow interior bore along its length, as shown by the dotted lines 6. It may be permanently closed at one end 7.

Member 5 acts as a fluid transport member to place fluid into or extract fluid from the balloon 1. One or more holes 9 spaced along member 5 permit fluid communication with the interior bore 6 which permits pressurized fluid , either a gas or a liquid, to flow to or from member 5 into balloon 1. The balloon is sealed around tubular member 5 at 10 to prevent fluid escaping from within the balloon 1. Sealing at 10 also fixes the balloon to the member 5. The other end 11 of tubular member 5 is opened except for a confined self sealing valve 13, best shown in FIG. 4.

Naive 13 is a circular membrane like structure located internally of the hollow tube 5 and extends across and seals the opened hollow passageway 6 in the tubular member 5. When valve 13 is penetrated by the pointed end of needle 3, fluid contained within the needle chamber 15 may be forced under pressure through the valve and into the interior bore 6 of tubular member 5 by means of the plunger 17. The fluid will flow through the bore 6 and exit out of the holes 9 into the interior of balloon 1.

To deflate the balloon 1, the procedure is reversed and the plunger 17 is moved to the left to draw out fluid from the balloon. Part, or all, of the hollow needle point 1 , with its opened front end 21, is inserted past the end valve 13 while the remainder of needle 3 is exterior of the tubular member 5. The needle 3 acts as external pressurized source of fluid having a valve penetrating member. A luer lock syringe (not shown) may also be used as needle 3 to add or remove fluid from the balloon.

Using a self sealing valve 13, enclosed by the tubular member 5, permits multiple insertions by the needle through the valve 13, to inflate or deflate the fluid pressure within the balloon. The arrows, in FIG. 1, indicate the direction a pressurized fluid would generally travel to inflate the interior of the flexible balloon 1.

FIG. 2 is a side view of the present invention while the balloon 1 is in a mostly deflated state. The balloon 1 is made of a nonallergic material and may be latex or non latex material depending on the patient's preference and medical history. The balloon is both deformable and flexible to allow for expansion in all directions when under pressure or contraction when the applied fluid pressure is removed or reduced. The fluid introduced into the balloon may be a gas or a liquid, with air being the primary fluid used.

The sealed distal end 7 of the member 5 may be attached to the adjacent interior surface of the balloon 1, if desired, to restrict expansion at that point. The fluid tight seal 10 is shown extending completely around the tubing 5 to prevent any escape of fluid from within the balloon 1 at that location. The size or volume of the balloon can vary to accommodate small, medium and large size uteruses. As shown in FIG. 2, the deflate balloon is substantially closer to the side surfaces of the enclosed portion of member 5. The length of the member 5 is selected to reach the upper limit of the endometrial cavity. The material selected for the tubular member 5 with its hollow bore 6 may be the same as that selected for the balloon or may be made from a different material and tailored to the needs of the user.

FIG. 3 schematically shows the inflated balloon 1 with the catheter inserted into the uterus 23 of a patient. Extending from the patient's cervix 25 is the tubular end 11 with the self sealing valve 13 completely within the tubular member 5. At the upper end the fallopian tubes 27 are shown. The endometrial cavity 29 is subject to distention for clinical benefits by inflating the inserted balloon 1 , using either the previously shown needle 3.

Included in the list of clinical benefits which can be achieved by the present invention are menorrhagia or recurrent and abnormal heavy uterine bleeding associated with local or systemic diseases. The inserted balloon catheter device can be used for short-term periods or long-term contraceptive benefits and may have other uses. The length of time the device remains in the uterus depends on the clinical situation. In acute, severe bleeding this catheter can be used to stop bleeding temporarily so a dilatation and curetlage can be arranged in the next few hours or days. When doing so, significant bleeding is prevented and its use may save a blood transfusion and other medical complications.

When used on a long term basis, the balloon catheter may be used for management of menorrhagla associated with dysfunctional uterine bleeding, anovultaion, or anatomic abnormality such as submucus fibroid or adenomyosis, or uterine hyperplasia. If a patient does not desire surgical intervention or medical treatment with hormones, a patient may use this catheter device for an indefinite period for management of menorrhagia associated with various conditions. Use of this purpose, in management of menorrhagia and heavy uterine bleeding, will prevent, in many cases , surgical intervention such as a D&C, hysterectomy, or myomectomy.

FIG. 4 is an end view of the tube 5 showing the self sealing valve 13. The valve 13 is disk shaped and extends completely across the hollow interior opening near or at the tubular end 11. The circular wall 31 forming the tube 5 is shown surrounding the self sealing valve 13. The valve 13 is completely within, and fixed to, the interior surface of the surrounding wall on all sides. The tubular bore 6 is hollow and extends to the sealed end 7 as best shown in FIGS. 1 and 2. Thus, the outer diameter of the membrane type valve 13 is coextensive with the inner diameter of the interior bore 6 and is located adjacent end 11 within the tubular member . This construction provides for a concealed and protected self sealing type of valve. By concealing and protecting the valve, the valve will not contact a patient's body parts. Using a self sealing valve insures that repeated use can be made of the valve without dislodging the catheter from the patient.

As previously mentioned, this invention is usable for both a short and long term basis. The time that the invention is in place may be several hours to several days, several weeks or to several months or even years. If used on a long term basis, the invention may be removed in the office at any time the patient desires. When used, either short or long term, the amount of fluid pressure created on the endometrium can be adjusted according to the amount of fluid (e.g.,air) introduced or removed. On one hand this fluid may be used to create pressure on the the endometrium.

It may also be used as a contraceptive device without increasing bleeding and cramps as is common in many currently used intrauterine contraceptive devices. In many cases it may be used to reduce or completely stop bleeding. Dysmenorrhea is also expected to be reduced because of pressure atrophy to the endometrium, which may reduce the release of prostaglandins and dysmenorrhea. As with other contraceptive devices, if the patient desires fertility the present invention can be removed from the endometrium at any time giving the patient the opportunity for fertility at any time. It may also be removed al any time from the endometrium for any change in the clinical situation.

In many patients it is expected that when used for a contraceptive purpose, the invention will be left in place for prolonged periods of time. It is also anticipated that the the risk of pelvic inflammatory disease will be reduced because of prevention of ascending infection because of pressure obliteration of the endometrial cavity as in pregnancy.

Although the preferred embodiment of the present invention and the method of using the same has been described in the foregoing specification with considerable details, it is to be understood that modifications may be made to the invention which do not exceed the scope of the appended claims and modified forms of the present invention done by others skilled in the art to which the invention pertains will be considered infringements of this invention when those modified forms fall within the claimed scope of this invention. What I claim as my invention is:

Claims

Claim 1. A balloon catheter for use in the uterus of a patient comprising: a fluid transport member having two ends and a length, said fluid transport member having a hollow interior passageway extending along its length; a balloon mounted to said fluid transport member, and said balloon being in fluid communication with at least one hole in the fluid transport member; and a self sealing valve located within the hollow interior passageway of the fluid transport member adjacent one end of the fluid transport member to seal the hollow interior passageway until penetrated by an external pressurized source of fluid.

Claim 2. The balloon catheter as claimed in claim 1, in combination with an external pressurized source of fluid, said external pressurized source of fluid having a valve penetrating member.

Claim 3. The balloon catheter as claimed in claim 2, wherein the self sealing valve in completely confined within the fluid transport member.

Claim 4. The balloon catheter as claimed in claim 3, wherein there are a plurality of holes spaced along the length of said fluid transport member to permit fluid communication between the balloon and the hollow interior passageway.

Claim 5. The balloon catheter as claimed in claim 4, wherein said hollow interior passageway of the fluid transport member has a first end and a second end, said first end being closed, and said second end is sealed by the self sealing valve.