DEVICE FOR ATRAUMATIC INTRODUCTION OF A MEANS INTO A TUBULAR ORGAN OF A LIVING BEING

Subject of Invention

The subject of the present invention is a device for atraumatic introduction of a means, preferably of a tubular, flexible means like a catheter, e.g. a catheter for artificial insemination, transfer of embryos, sterile taking and application of samples into a tubular organ of a living being.

Technical Problem

A technical problem solved by the present invention is how to design a device that would allow for atraumatic introduction of a means in the shape of a tubular and flexible object, preferably a catheter, e.g. a catheter used in artificial insemination, transfer of embryos, sterile taking and application of samples, to a predefined and from the input part optionally distant spot in a tubular organ, preferably reproductive tract, that would simultaneously also exclude a possibility of an infection and/or damage of the interior of a tubular organ, whereas the introduced tubular means will allow for a simple and uncomplicated introduction of an optional active agent into the interior of said tubular organ, e.g. seminal fluid in minimal quantities in the method of artificial insemination, or an instrument to perform procedures in the interior of said tubular organ.

Prior Art

Catheters of adequate designs are often used to enter tubular organs in order to set diagnosis and to provide treatment as well as inseminating. In the insemination method semen is introduced by means of a catheter deep into the reproductive tract. Substantial loss of semen on the pathway through the external parts of the reproductive tract is thus prevented. In a method of this type a flexible thin catheter is introduced through a catheter of a large diameter and then advanced into the reproductive tract.

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Mucous membrane can get damaged or even the uterus wall may get perforated. Since the catheter is introduced from the external parts of the reproductive tract into the interior, there is great danger of an infection being spread into the deeper parts of the reproductive tract. In order to do away with the drawbacks of said method, numerous solutions have been presented. US 6,526,917 discloses a device for introduction of a means in the shape of a membrane, with which semen is introduced into the interior of the reproductive tract during insemination method. The device is composed of a rigid external tube and a flexible membrane of a decreasing diameter placed within the tube. With its wide section the membrane is fastened at the end of the rigid tube to be inserted into an organ, and the other end is narrowed into a sharp point. At the opposite, external section of the rigid tube there is a shrinkable container or a syringe of a sufficient volume. The container contains semen fluid. By advancing the semen fluid into the rigid tube, pressure is created within the tube causing the flexible membrane to begin unfolding from the rigid tube into the interior of the organ. With the entire membrane unfolding from the rigid tube, the top of the membrane opens due to the pressure and the diluted semen flows into the interior of the reproductive tract. Compared to a classic catheter the described device has a series of advantages, especially a lower possibility of injuries of the mucous membrane and organ walls, a lower possibility of infection spread into the interior of the reproductive tract and improved application of semen deep into the reproductive tract.

In order to create a sufficient pressure within the tube or membrane that causes the membrane to unfold from the rigid tube, a fluid quantity high enough is needed. Since semen is usually not present in such big quantities, it is mixed with a fluid and introduced into the reproductive tract in a much diluted form. The introduction of highly diluted semen instead of concentrated semen has a very negative impact on the success of insemination. Further loss of semen resulting in a negative impact on insemination is also caused by great volume and thus the interior walls of the device against which the active semen gets stuck. When the membrane extends, not only semen but also the fluid flows into the interior of the organ. Since larger quantities of

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fluid need to be introduced, the possibility of infection spread into the interior of the organ is higher. Air may also be used as a means to create pressure, which also presents an eventual infection source.

With the fluid or air entering the rigid tube in the axial direction of the tube, highest pressure is exerted on the top of the membrane, which can cause the membrane to fold instead of unfolding from the tube. If this is the case, the membrane may get stuck in the rigid tube and the insemination method fails to be performed.

Should the described device be used for other purposes, e.g. in order to set a diagnose, the fluid is removed after the membrane has unfolded either by breaking the membrane to allow the fluid to run into the organ, or by sucking the fluid out from the membrane. In the first case the organ is filled with the fluid, which may cause problems during procedures, in the second case, the walls of the emptied membrane get folded and shrunk thus obstructing or even preventing an instrument to pass through. The membrane wall or even the interior organ wall may get perforated.

Solution to the Technical Problem

The described technical problem is solved by the device of the invention, said device being composed of a rigid tube closed at one end, of a tubular, flexible membrane inserted into the rigid tube, said membrane being fastened with one of its ends at the end of said rigid tube to be inserted into an organ, and of a unit to create pressure within said rigid tube, whereby the device contains a flexible tube, one end of which is linked to the end of said membrane located in the interior of said rigid tube so that it perforates said membrane and protrudes into its interior, whereas another end protrudes from said rigid tube and is hermetically closed. The length of said flexible tube equals or exceeds that of said membrane. A pressure unit of an optionally known type, like syringe, pump, that creates pressure within said rigid tube by means of a fluid, is arranged on an optional spot near the device. Said pressure unit is linked to said rigid tube via small flexible tube at the end of said rigid tube to be inserted into an organ, so that the fluid entering the area between said rigid tube wall and said

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membrane creates highest pressure immediately on the spot of unfolding of said membrane from said rigid tube.

Due to increased pressure resulting from the introduction of a fluid into said rigid tube said tubular membrane unfolds from said rigid tube into the interior of said tubular organ and draws said flexible tube with its other, interior end. With the entire membrane unfolded from said rigid tube, the free protruding end of said flexible tube, preferably designed as a catheter, is located on the previously determined location within a tubular organ. A desired substance, e.g. semen, embryos, medicaments and the like, is applied through said flexible tube into the interior of an organ. Should diagnostication or treatment be the case, a catheter large enough is used as the flexible tube to allow for an instrument of a known type to pass through, or rather the first part of an instrument is fastened to the end of said membrane instead of said flexible tube. The fluid that creates pressure within said rigid tube remains within said rigid tube and said membrane and does not come into contact with an internal organ. After the procedure is completed, the fluid is sucked from said rigid tube and said membrane back to said pressure unit, said flexible tube is taken out and said membrane is taken out simultaneously.

The device conceived in this way has numerous advantages. Due to its flexible tube said device allows for the application of a minimum substance quantity to a previously defined location. Said flexible tube has smooth internal walls thus significantly preventing adhesion of the active substance. Since the volume of said flexible tube is very small, a minimum substance quantity is needed to successfully perform a procedure, so there is no need for supplemental, carrying fluid. The applied substance has a composition required by the procedure, which significantly contributes to the success of the results for instance in insemination. The application spot is determined by means of the membrane length. The unfolding of said membrane from said rigid tube is monitored during the introduction of said means into an organ simply and continuously by means of the length of still to be inserted flexible tube.

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The device of the invention renders it possible to substantially aseptically insert said means to an optionally remote spot in the interior of a tubular organ, since during the advancement into the interior of an organ said membrane does not advance by the principle of pushing, but ever new part of said membrane, which is free from infects comes in contact with an organ wall. The free end of said introduction means, through which e.g. semen is applied, is protected with said membrane all the pathway through an organ and comes in contact with the interior of an organ only on the specified location.

Since the fluid used to create pressure for the unfolding of said membrane never comes in contact with any part of an interior organ during the entire operating time of the device, a possibility of infection spread into the interior of an organ is completely prevented.

A possibility of complications emerging during the introduction of said means into a tubular organ is held at the minimum. Since fluid is introduced into said rigid tube directly on the spot of membrane unfolding, said membrane cannot get folded and stuck within said rigid tube.

During the whole procedure from the beginning of unfolding until the completion of a certain procedure, said membrane is extended to its largest diameter. In this way any folding of membrane walls or squeezing of walls is prevented, which could otherwise lead to the perforation and damage of an interior organ wall.

An adequate design of said membrane may be used to plan its pathway within branched tubular organs, e.g. to be introduced into a certain section of uterus.

In order that the present invention be more readily understood, an embodiment thereof will now be described by way of example with reference to the accompanying drawings in which:

Fig. 1 shows a cross-section of the device for atraumatic introduction of a means of the invention,

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Fig. 2 shows a cross-section of the device for atraumatic introduction of a means of the invention in the situation with a flexible tube inserted,

Fig. 3 shows a cross-section of an embodiment of the device for atraumatic introduction of a means of the invention with the flexible tube folded.

Fig. 4 Replaceable part of the device for atraumatic introduction of a means of the invention.

A device for atraumatic introduction of a means, preferably of a tubular, flexible object like a catheter, into a tubular organ of a living being consists of a rigid tube 1, in which a flexible tubular membrane 2 is arranged. Said membrane 2 is tightly fastened with one end 9 with a sealing ring 13 to the end 10, which is inserted into an organ, of said rigid tube 1. The opposite end 8 of said membrane 2 is located in the interior of said rigid tube 1. The other end 11 of said rigid tube 1 is hermetically closed by a plug 12 and located outside the organ during the procedure. Within said rigid tube 1 a flexible tube 3 is located, said flexible tube 3 being linked with one its end 6 to the interior end 8 of said membrane 2 in a way to perforate said membrane 2 and to protrude into its interior, whereas another end 7 of said flexible tube 3 extends through an opening 14 of said plug 12 outside from said rigid tube 1. The link flexible tube 3 / membrane.2 is provided in an air-tight manner. Said opening 14 is designed in a way to allow for said flexible tube 3 to advance freely while being introduced into an organ and simultaneously to prevent the outflow of a fluid having adequate viscosity. At the beginning of its introduction into a tubular organ the whole flexible tube 3 is substantially extended outside said rigid tube 1. An end 7 of said flexible tube 3 is intended to receive an optional device for the application of a substance into an organ or to receive an instrument of known type, whereas said device or said instrument is arranged on said end either from the very beginning of the introduction of the means into an organ or arranged thereon at a later stage and said end 7 of said flexible tube remains hermetically closed during the introduction.

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In the embodiment shown on Fig. 3 said flexible tube 3 is folded within said rigid tube 1 and only an end intended to receive an adequate device protrudes through said plug 12. In this case air may be used as a means to establish pressure. Unfolding of said membrane 2 and advancing of said flexible tube 3 can be here monitored by an ultra sound device.

A pressure unit 5 of an optional known type, e.g. syringe, pump, that creates pressure within said rigid tube 1 by means of fluid, is arranged on an optional spot near the device. Said pressure unit 5 is linked with said rigid tube 1 via tube 4 that enters said rigid tube 1 at said end 10, inserted into an organ, of said rigid tube 1, in a way that the fluid flowing into the area between the wall of said rigid tube 1 and said membrane 2 creates highest pressure directly on the spot of unfolding of said membrane 2 from said rigid tube 1.

Diameter, length and shape of said membrane 2 depend on the type of procedure to be carried out and on the type of a tubular organ. The length of said flexible tube 3 depends on the length of said membrane 2, whereas the length of said flexible tube 3 equals or exceeds that of said membrane 2. If a tubular organ is internally branched, the pathway of introduction is defined by the adequately shaped membrane 2.

All component parts of said device are manufactured of materials having adequate mechanical properties to allow each part to perform its function. It goes without saying that all materials should be harmless to living beings subjected to procedures and chemically resistant to substances in the body of living beings.

Said device may be designed in a way to be reusable, whereby said membrane 2 together with said flexible tube 3 forms a replaceable part of said device to be arranged within said rigid tube 1 and adequately sealed by said plug 12 or said sealing ring 13.

It is understandable that a man skilled in the art can also design other changes to embodiments based on the knowledge of the above description without circumventing the essence of the invention defined in the appended claims.

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