WO2005025473A1

WO2005025473A1 - An object for filling body cavities, such as nasal cavities

Info

Publication number: WO2005025473A1
Application number: PCT/DK2004/000615
Authority: WO
Inventors: Rolf Steno; Niels Hvid; Erik Lund Jepsen
Original assignee: Stenocare Aps
Priority date: 2003-09-18
Filing date: 2004-09-16
Publication date: 2005-03-24
Also published as: DK200301355A

Abstract

In case of bleeding in body cavities, such as nasal cavities (15), a slight pressure will normally have to be applied to the bleeding mucosa in order to stop the bleeding. For this purpose, according to the invention, an object (4) is used, comprising an operating element, such as a length of pipe (7) around which a foam core (12) is attached, and which is terminated outermost by a film bag (5). The foam core (12) is made of a slowly expandable foam, which allows the object (4) to be shaped, as needed, prior to the insertion. When a haemostasis (13) has been formed, the object (4) may be withdrawn, and since the film (5) will turn over the haemostasis (13) by a pull at the pipe (7), this may take place without any trouble of any kind. This reduces the risk of re-bleeding and pain, and since body fluid, if any, will run inside the film, a high degree of hygiene will be achieved.

Description

AN OBJECT FOR FILLING BODY CAVITIES, SUCH AS NASAL CAVITIES

The prior art

The invention relates to an object for filling body cavities, such as nasal cavities and hollows after surgical interventions, comprising a foam core having a longitudinal operating element and an outer film sheath.

Objects of this type are preferably used for nose-bleeding, where the object is inserted via the nostril into the nasal cavity in which, when the foam object is expanded, it will apply a slight pressure to the walls of the nasal cavity. In normal circumstances, this will stop the bleeding within a short period of time, following which the object may be withdrawn.

Nose-bleeding may occur after a blow or a stroke, just as bleeding may occur when the blood vessels, in particular on the front part of the nasal septum, expand until rupture.

Since, in particular, the bleeding thus takes place on the movable mucosae in the wall of the nasal cavity, a haemostatic aid must be capable of being adapted to various shapes and sizes of cavities.

Objects of open celled foam are frequently used for this purpose, and of these particularly PVA (polyvinyl alcohol) foam rubber. The reason is that it has the property that in a dry state it can be compressed and shaped so that the object may easily be given a cross-sectional shape which permits it to be inserted through the opening, such as the nostril, without difficulty.

After the insertion into the cavity, the foam core will expand when liquid is supplied, whereby it will apply a slight pressure to the walls of the cavity and thereby normally stop the bleeding within a short time. An example of such an object is known from the specification of US 6 183 436. The known object consists of a core of open celled foam having a pipe extending therethrough, said parts being enclosed by a protective film.

The purpose of the film is to facilitate the insertion and allow body fluid to penetrate into the foam core itself in order for this to expand. However, this known object has the serious drawback that penetration of body fluid will interfere with the withdrawal of the object, partly because of the occurred hardness of the foam caused by liquid, and partly because the foam has expanded. To this should be added that, when being withdrawn from the body cavity, the film will tear the solidified blood, the haemostasis, longitudinally of the skin and in a simultaneous movement. This will frequently cause renewed bleeding, to which should be added that the withdrawal causes considerable pain, since the entire haemostasis is pulled off at once. A further concern is the danger of infection which the withdrawn object constitutes.

The object of the invention

The object of the invention is to remedy these drawbacks and troubles in the form of re-bleeding, pain and danger of infection, and this is achieved according to the invention in that the film sheath is configured as a bag which encloses the foam core and the operating element, and which is open in the area around the free end of the pipe and secured to the other end thereof. This avoids all the described drawbacks and troubles at the withdrawal of the object after bleeding has stopped, as the withdrawal may take place by a pull at the free end of the operating element, that is the end disposed outside the nostril. Hereby, the foam core comes first and then the outermost parts of the film sheath, following which the rest of the sheath will follow, but in such a manner that it will "turn" during the further withdrawal. This progressive turning will ensure that the adhesion to the haemostasis will be loosened gradually by a pull more or less transversely to the haemostasis and beginning innermost and then outwardly, following which the entire haemostasis is exposed.

In this surprisingly simple manner, a successive smoothly sliding rolling will take place, which is far more gentle, and which will not cause tearing of the wound area with consequent bleeding again. To this should be added that this withdrawal is far less painful, as it reduces tearing to a slight pull in a limited area, and that the pain will therefore be limited correspondingly. Fi- nally, the risk of dissemination from the pus present on the sheath will be eliminated, since the pus will run internally on the withdrawn film bag and thus cannot make direct contact with the fingers.

When, as stated in claim 2, a slow recovery foam is used as a core, the object may easily be shaped prior to the insertion, and since the foam only recovers its original volume after a suitable period of time, there will be time enough for inserting the object in a compressed state into the cavity.

When, as stated in claim 3, the operating element is configured as a length of pipe, a suitably flexible, resilient insertion means is achieved, which ensures gentle insertion of the object into the cavity, and which, by having an air passage through the pipe, allows breathing air to pass unobstructedly through the object. This will have a sedative effect on the user, who will feel it as a relief that he can resume his normal breathing.

When, as stated in claim 4, the free end of the pipe is funnel-shaped, there will be no risk that the object is moved too far into the cavity, since the diameter of the pipe will be larger than the access opening, such as the nostril. Further, the object may be operated more easily during insertion as well as during withdrawal, since the funnel will serve as a gripper member. When, as stated in claim 5, the funnel-shaped free end of the pipe is provided with a collar or the like, the withdrawal will be simpler in that a pull may be applied to it.

When, as stated in claim 6, the film is coated on its outer side with a liquid repelling layer (easy slip layer), blood and other liquids cannot adhere to the film, which can therefore be withdrawn without trouble, since the film cannot adhere.

When, as stated in claim 7, the film sheath is prepared on its outer side with selected medicaments, such as blood stopping agents and the like, a medical effect may be achieved in addition to the physical effect.

When, as stated in claim 8, the object is packaged in a sheath, it is possible to configure the foam core without direct contact with the film sheath on the object, such that it may be given a shape allowing insertion of the object to take place without difficulty by using the package sheath as an insertion means. This ensures that the object is untouched and sterile when it is inserted.

The drawing

An example of an embodiment will be described more fully below in the form of an object for stopping nose-bleeding with reference to the drawing, in which fig. 1 shows packages with three different objects, fig. 2 shows four identical objects contiguous in insertion sheaths, fig. 3 shows an object during shaping of the foam core, fig. 4 shows an object in a partially open insertion sheath, fig. 5 shows an object ready for insertion by means of the opened insertion sheath,

) fig. 6 shows the object itself, fig. 7 shows a sectional view of the object inserted into a nasal cavity, fig. 8 shows the object during withdrawal from the nasal cavity, fig. 9 shows a section of the rear part of the pipe in an open (dashed line) and a closed state, and figs. 10 and 11 show an example of a package for the shaping of the object prior to insertion.

Description of an exemplary embodiment

An object according to the invention will be described more fully below as a nosebleed stopper - but it may be used in a corresponding manner for the filling of other body cavities, such as vagina and body hollows produced by the removal of organs or tissue.

The object 4 itself will be described with reference to fig. 6.

The core of the object is a foam object 12, which is preferably of the vis- coelastic type, such as special variants of PUR, PVC or similar materials.

This foam has the property that it may be compressed and be shaped, fol- lowing which it will slowly expand to the original shape. This property makes it suitable for use in a compress, as, prior to the insertion into the cavity, it may be compressed to a cross-sectional shape allowing easy insertion, and then, positioned in the body cavity, it will slowly expand and thereby fill the cavity, where it will press against the sides of the cavity.

As shown in fig. 6, a suitable piece of foam 12 is provided with a through channel in which an operating element in the form of a length of pipe 7 extends. This length of pipe 7 is preferably made of soft plastics.

As will appear from fig. 6, the front end 6 and the rear end 9 of the pipe 7 protrude on both sides of the foam core 12.

The rear end 9 of the pipe 7 is preferably expanded to form a funnel. The purpose of this is to ensure that, at inhalation and insertion, the pipe and thereby the object 4 are not inserted deeper than the pipe end 9 remains outside the nostril.

A gripper means is shown at the pipe end 9, which, in the example shown, is formed by a ring 8 which may be released partly from the pipe end 9 when the object 4 is to be withdrawn after use. The end 9 of the pipe 7 itself may also be formed with a collar (not shown) with which the object 4 may be operated at the insertion as well as at the withdrawal.

A film sheath 5 extends around the foam core 12 with the pipe 7. The purpose of this sheath 5 is to serve as a barrier such that body fluid, blood, etc. cannot penetrate into the foam. This prevents body fluid from penetrating into and making the foam core 12 stiff, which would impede the withdrawal and involve a risk of tearing of the haemostasis.

Various medicaments, such as liquid repelling agents, slide agents, blood stopping agents or medical agents, as needed, may be applied to the film on its outer side.

It should be noted that the film 5 is open around the pipe 7 to form an air opening into the foam core 12. The purpose of this opening is to allow the foam to "breathe" during its shaping and later expansion and, as shown in fig. 8, to be pulled out of the film bag 15 at the withdrawal of the object.

At the front end 6 of the pipe 7, the film 5 is attached to the outer side of the pipe in a generally known manner, such as by welding, gluing, shrinkage

10.

The pipe 7 also constitutes the operating element which guides the object at the insertion into the cavity as well as at the withdrawal therefrom. The foam core 12 is therefore adhered to the outer side of the pipe 7, so that it can follow the pipe at the operation.

Finally, the pipe 7 has an air passage in that the film 5 is perforated at the pipe end 6. The pipe 7 will hereby be capable of serving as a push rod at the insertion and as a pull rod at the withdrawal of the object after use, and will allow breathing air to pass through the pipe, as indicated by arrows.

Where the object is to be inserted to a cavity where air/liquid passage through the pipe 7 is inexpedient, the pipe end 9, as shown in fig. 9, may be provided with a seal in the form of a piece of film 18 which may be torn and thereby be opened, as needed.

The packaging and the application of the object will be described now.

Since there will be various variants of the object, they are preferably packaged in labelled packages 16, as indicated in fig. 1. Fig. 2 shows four ob- jects in closed sheaths 1 by way of example. Each object 4 is preferably packaged in a sterile manner in these.

Fig. 3 shows a single object 4 in its package sheath 1 during the forming of the object by compression with the fingers. The sheath 1 may then be opened partially in that the package layers 2 and 3 are separated partially, as indicated in fig. 4.

The object 4 may then be inserted into the nasal cavity, it being possible to insert it by means of the sheath 1 as a holding part without it being touched by the fingers, as indicated in fig. 5.

Instead of a soft package sheath 1, a decided moulding tool may be used, e.g. as shown in figs. 10 and 11. It comprises a rigid upper part 15 and a cooperating lower part 17 having flexible side faces 16. The object is disposed in this sheath, and, as indicated in fig. 11 , the object will be formed to a flattened object by pressing-together of the parts, such that it gets a shape most expedient for the insertion.

After the insertion into the nasal cavity 15, it will expand, as shown in fig. 7, and will thereby clamp the film 5 against the sides and thereby also the area with the ruptured blood vessel 13. This pressure will rapidly stop the bleeding, and a small cake of blood, haemostasis, 13 will be created.

It is noted that the pipe end 9 with the gripping element 8 extends outside the nostril, and that, as indicated by arrows, breathing air can freely pass through the object via the pipe 7.

The withdrawal, removal, of the object after use will now be described with reference to fig. 8. Withdrawal takes place by a slight pull at the ring 8 and thereby at the pipe 7. Since the film 5 is attached to the front end 6 of the pipe 7, the film will "turn" during this withdrawal and thereby be released from the adhesion to the haemostasis 13.

The release takes place in a gentle manner, as it will take place successively over the turning edge of the film 5. This will reduce the risk of re- bleeding, which will typically occur where the entire haemostasis is removed at once, and in particular where the pull takes place longitudinally of the haemostasis.

Furthermore, this gentle tearing is less painful, since the haemostasis and vibrissae, which might be present in the haemostasis, will not adhere to the film so that no tearing will occur when the film is withdrawn.

The turning of the film 5 will moreover ensure that body fluid, such as pus and blood, will be contained in the sheath, which provides a good hygienic solution with a minimal risk of dissemination from the object after its use.

Other configurations (not shown) of the film sheath, the operating element and the foam object than those shown, are conceivable. When e.g. these parts are provided with a helical tear groove and the front end is attached to a withdrawal object, such as a pipe, a pin or a cord, the object may be withdrawn by tearing the groove by a longitudinal pull outwards. This will facili- tate the withdrawal particularly in deep cavities, as the object will emerge as a string at the withdrawal from the cavity.

The operating element may be configured in other ways than as a length of pipe, viz. as a solid element which may be suitably flexible owing to the ad- aptation of the object. Further, the foam object may be made relatively rigid, whereby the operating element is reduced to a withdrawal element, which may be made of e.g. thread or the like.

The foam object may conceivably be integrated with a form of film sheath in that the foam on the surface is formed with a closed smooth surface that constitutes the film layer.

Finally, it is conceivable that the object is formed by a bag object in the form of an air-tight bag which may be evacuated via a valve and thereby be flattened and may subsequently be filled to form the object when it is inserted into the cavity.

Finally, the object may be vacuum-packaged in a flat state and be provided with a seal, which may be torn, opened, so that air is admitted into and expands the foam core.

Claims

PATENT CLAIMS

1. An object for insertion into and filling of body cavities, such as nasal cavities and hollows after surgical interventions, comprising a foam core having a longitudinal operating element and an outer film sheath, char- ac terized in that the film sheath (5) is configured as a bag which encloses the foam core (12) and the operating element, and which is open in the area around the free end (9) of the operating element and secured (10) to the other end (6) thereof.

2. An object according to claim ^characterized in that the foam core (12) is made of slow recovery viscoelastic foam, such as PUR, PVC foam.

3. An object according to claim ^characterized in that the operating element is in the form of a length of pipe (7), which is open at its other end (6) for air passage through the film sheath (5).

4. An object according to claim 3, characterized in that the free end (9) of the pipe (7) is expanded to form an insertion stop.

5. An object according to claims 3 and 4, characterized in that the free end (9) of the pipe (7) is provided with a gripper element (8), such as a collar, a ring or the like.

6. An object according to claim ^chara cterized in that the film sheath (5) is provided with a surface on the outer side which is non-adhesive for body fluids.

7. An object according to claim 6, characte r ized in that the film sheath (5) is impregnated with medicaments, preferably to promote blood solidification and/or addition of curing agents, such as antiseptic agents, insulin, vitamins, etc.

8. An object according to any one of claims 1-7, characterized in i that the object (4) is packaged in a sheath (1) which may be opened by separation of the package layers (2, 3) for insertion of the object (4) into the body cavity (15).