A DEVICE FOR INSERTING INTO A BODY ORIFICE AND A METHOD FOR PRODUCING THIS DEVICE

Abstract: The object of this invention is to provide a device for insertion into a body orifice such as the vagina, anus, a colostomi or an ileostomi which device comprises a body to which a string is attached. The device has a smooth and comfortable surface, is simple and inexpensive to produce and has at least one string so strongly secured to the body of the device that the string does not get detached even at extreme conditions. Also the fastening of the string inside the device does not prevent the device from being pressed to half size and inserted in an applicator. This object is obtained when at least one string by which the device may be pulled out is formed with means e.g. a soft material secured to the string or one or more loops. Preferably loop(s) can be secured on the string by a knot.

Description: 1 TITLE A device for inserting into a body orifice and a method for producing this device. FIELD OF THE INVENTION The present invention relates to a device for inserting into a body orifice, a method for producing this device and a method for securing a string in a device for insertion into a body orifice. The device comprises a body made of an elastic and moulded material which is to be placed in the body orifice and the body of the device is provided with a string which can be used when the body is to be removed from the orifice. BACKGROUND OF THE INVENTION Various devices are designed to be placed in a body orifice for shorter periods of time, e.g. in the vagina for the purpose of absorbing fluids or for preventing incontinence by supporting the bladder neck, or in the anus or a stoma orifice for preventing faecal incontinence, Such devices are normally provided with means for facilitating the removal of the device. The means may be a finger grip formed as an integrated part of the device or it may be a string or similar protruding from the device and in some cases even projecting of the orifice and renders it convenient to grip and pull out the device. A well-known method for securing a string in a removable body is by sewing but when the device is moulded the insertion of the string by sewing makes the process more expensive as compared to a process where a string is incorporated during moulding. A simple way to incorporate the string during moulding is to let the string form an arch in order to let the string enter the device in one site and exit from the device at another site whereafter the two ends of the string are joined.. This method is known from EP B1 - 0 363 421 in connection with a device for controlling female urinary incontinence wherein the string enters and exits the body at the distal end as described in figure 2 of this document and the joined string is protruding from the vagina to allow easy removal. This positioning of the string assures that the string will not be pressed against the wall of the vagina by the body of the device during use. The advantage of this known product is that when the string is in the correct position it requires an acceptably high extraction force to pull out the string from the body of the device, and the cost of production for this product is very low. The disadvantage of this method is that it is quite difficult to position the string correctly. When the string is not positioned correctly, the string does not necessarily show an acceptable extraction force and another problem is that if the string is placed to close to the walls of the body, the structure of the moulded material between the string and the surface can - depending on which material is used - change and this can result in the formation of hard spots which are perceptible for the user. A way to avoid this problem is to carry the string through the moulding form and join the two ends together instead of making an arch through one side of the device but doing this will render it impossible to both lead the string into and out of the body through passages in the distal end surface and the string would, in use, be positioned between the walls of the body orifice and the body, at least when the body is of a compact form which means a form that is not to be folded when inserted in the body orifice. The user will be able to feel the string when such a compact device is placed in the body orifice and the efforts to make the surface and the structure of the device smooth and comfortable would be more or less in vain. Another possibility is to carry the string through the moulding form from the distal end of the device to the proximal end and then cut of the proximal part of the string at the surface of the device. This production method resulted in very low costs but the force needed to detach the string from the device has turned up to be too low under extreme conditions and the material tends to become hart around the top (the proximal end) of the product where the string is cut of. BRIEF DESCRIPTION OF THE INVENTION The invention relates to a device for insertion into a body orifice which device comprises a body having a distal and a proximal end and being made of an elastic and moulded material, and at least one string which is secured to the body during moulding. Furthermore, the invention relates to a method for making a device for insertion into a body orifice which device comprises a body having a distal and a proximal end and being made of an elastic and moulded material, and at least one string which is secured to the body during moulding. Still further, the invention relates to a method of securing a string in a device for insertion into a body orifice. DETAILED DESCRIPTION OF THE INVENTION The object of this invention is to provide a device for insertion into a body orifice comprising a body made of an elastic and moulded material and at least one string which is secured to the body during moulding. The device has a smooth and comfortable surface, is simple and inexpensive to produce and has at least one string so strongly secured to the body of the device that the string does not get detached even at extreme conditions. Also the fastening of the string inside the device does not prevent the device from being pressed to half size and inserted in an applicator. The invention relates to a method for securing a string in a device for insertion into a body orifice which device comprises a body having a distal and a proximal end and being made of an elastic and moulded material, and at least one string which is secured to the body during moulding wherein a first string is provided with holding means and is placed in a mould for preparing the device in such a manner that it exits the distal part of the mould and filling the mould with the material forming the device embedding the string. This object is obtained when means are formed or secured on at least one string which exits from the distal end of the body of the device, when at least one string exits the proximal end of the body of the device and these strings are connected or only is constituted by one string. The means can be a soft material secured to the string by e.g. sewing or it can be one or more loops formed on the string. A loop is defined as a closed circle of string enclosing an amount of material of the body of the device. Preferably the loop(s) can be secured on the string by a knot. It is an advantage to use at least two strings as it is then possible to vary the thickness and the strength of the string(s) passing out of the distal and the proxi- mal end of the device respectively. The string which exits the distal end has to be strong enough to resist the extraction force when the device is pulled out of the orifice. The string which exits the proximal end only has to be strong enough to keep the string(s) in position until the material has filled the moulding form. Also a string with a small cross section passing out of the proximal end of the device does not leave a hard spot at the point where it passes through the surface of the body of the device. So in order to keep the surface of the proximal end of the device smooth and comfortable the string or strings passing through the proximal end of the body of the device can have a reduced total thickness, preferably a total thickness below 0,5- 10 "3 m or more preferred below 0,3-10 3 m. It appears that one or two threads with a total thickness as ordinary sewing thread is suitable. The invention also relates to a method for making a device comprising a body made of an elastic moulded material and at least one string secured to the body which method comprises the following steps: a) holding means are secured to or formed on at least one first string, b) this string(s) alone or connected to one or more second string(s) is/are positioned in a moulding form where at least one first string exits the distal part of the moulding form and at least one second string exits the proximal end of the moulding form, c) the raw materials are prepared and the moulding form is filled, d) the material at least partly hardened, e) the device is removed from the form, f) the device is optionally dried. Still further, the invention relates to a method for securing a string in a device for insertion into a body orifice which device comprises a body having a distal and a proximal end and being made of an elastic and moulded material, and at least one string which is secured to the body during moulding wherein a first string is provided with holding means and is placed in a mould for preparing the device in such a manner that it exits the distal part of the mould and filling the mould with the material forming the device embedding the string. BRIEF DESCRIPTION OF THE DRAWINGS The invention is explained more in detail with reference to the drawings in which Figure 1 shows a sectional view of a standard device not forming part of the invention, Figure 2 shows a sectional view of a preferred embodiment of a device of the invention, Figure 3 shows a sectional view of another preferred embodiment of a device of the invention, and Figure 4 shows a graphical presentation of the extraction force of string from device for different devices. DETAILED DESCRIPTION OF THE DRAWINGS Figure 1 shows a sectional view of a standard state of the art device. This device comprises a string 1 and a body 5 made of a foam material for example as described in DK patent application no. 0014/98. The string is secured to the device during moulding and the double string 1 pass through both the distal end A and the proximal end B of the moulding form in order to assure the position of the string. Figure 2 shows a sectional view of a device representing a preferred embodiment of the invention. This device comprises a string 1 , a thread 4 (drawn in a thinner line) and a body 5. The string 1 is made with a loop 2 and the thread 4 is connected to the string 1. The thread can be connected to the string in many ways but a simple way is to tied the string and the thread together in a knot. The double string 1 and the thread has been placed in an elastic body 5. This device has been manufactured according to the invention by forming a loop on a string and connecting the string to a thin thread. The connection between the string and the thread has been made by tying the string and the thread together in a knot and afterwards the double string and the long ends of the thread are separated and placed in a moulding form with the string stretched out of the distal end and the thread stretched out of the proximal end then they are secured in order to keep the position. Then the moulding forms are filled with the elastic material and the material allowed at least partly to harden. When the products has at least partly hardened they are removed from the moulding forms and dried. After drying the long thread at the proximal end is cut off right above the surface of the body of the product. Reference is made to Figure 3 showing a sectional view of a device representing another preferred embodiment of the invention. This device comprises a double string 1 , a thread 4 (drawn in a thinner line) a piece of soft tissue 3 and a body 5. The double string 1 is secured to the soft tissue 3 with the thread 4. The thread 4 is used to sew the double string 1 to the soft tissue 3. The double string 1 , the thread 4 and the soft tissue 3 are embedded in an elastic body 5. Figure 4 shows the extraction force needed to pull the string out of various devices. Experience has shown that for the string to be unreleasably secured to the body of the device even when the device has to be withdrawn from the body orifice under extreme conditions the extraction force needed to release the string from the body of the device should be above approximately 40 N. EXPERIMENTAL PART Different embodiments of devices were tested in order to establish which embodiment had appropriate low production costs and at the same time had an extraction force for the string at least about 40 N. Experiment 1. In the standard device shown in Fig. 1 a double string forms a loop outside the body of the device and the two strings runs parallel from the distal to the proximal end of the body where the strings are secured during moulding. The device was very economical to produce but it had an extraction force of only 18-30 N. In order to increase this extraction force the following ways of fastening the string to the body of the device was tried: Experiment 2. A foam anchor of the same material as the body of the device was secured to a double string and afterwards the double string and the foam anchor was moulded into the body of the device. The device showed an extraction force for the string of about 24-28 N. Experiment 3. The string was sewed into the body of the device using a needle drawing the string from the distal end to the proximal end of the device and back. The string of this device showed and extraction force of about 39-58 N. Experiment 4. One knot was tied on a double string and afterwards the string was secured to the body of the device during moulding. The extraction force for the string of this device was about 27-32 N. Experiment 5. Two knots were tied on a double string which was afterwards secured to the body of a device during moulding. The extraction force for the string of this device was about 18-31 N. 8 Experiment 6. A releasable loop of 10 mm was formed on the double string and afterwards the double string was secured to the body of the device during moulding. The extraction force for the string of this device was about 60-67 N. Experiment 7. A non-releasable loop of 10 mm was formed on the double string and afterwards the double string was secured to the body of the device during moulding. The extraction force for the string of this device was about 55-70 N. Experiment 8. A loop of 10 mm was formed on a double string and a single string was attached to the knot. Afterwards the strings were embedded in the body of the device during moulding with the double string protruding the distal end and the single string protruding the proximal end. The extraction force of the string of this device was about 52-57 N. Experiment 9. A device as shown in figure 2 using a string with a loop of 10 mm. The extraction force of the string was about 60-72 N. Experiment 10. A device as shown in figure 2 having a string wherein the loop has been cut up and no longer performs a closed circle was produced. The extraction force of the string was about 28-32 N. It seems to be a significant parameter that part of the elastic moulded material is caught in the loop. What size the loop or several loops has to have depends on the moulded material and on the string forming the loop. A maximum and a minimum loop size has to be determined for every material. Experiment 11. A sheet of soft tissue was secured to a double string as shown in figure 3 and afterwards the sheet and double string were embedded in the body of the device during moulding. The extraction force was about 60 - 67 N. It seems that adhesion between the soft tissue and the body is significantly better than just to the string itself. The optimal size of the soft tissue has to be determined for every size and design of the body.

Claims: 10 CLAIMS 1. A device for insertion into a body orifice which device comprises a body having a distal and a proximal end and being made of an elastic and moulded material, and at least one string which is secured to the body during moulding CHARAC- TERISED IN that at least one first string which string exits from the distal end of the body of the device is provided with holding means, that at least one second string exits the proximal end of the body of the device, and that these strings are connected inside the body or is constituted by only one string. 2. A device according to claim 1 CHARACTERISED IN that at least two strings, a first string and a second string, are placed in the body. 3. A device according to claim 2 CHARACTERISED IN where at least one first string exits the body's distal end and at least one second string exits the body's proximal end and the first and the second string are connected. 4. A device according to claim 3 CHARACTERISED IN that the first string(s) has a total thickness larger than 0,5-10 3 m preferably larger than 0,9-10 3 m, and that the second string(s) has a total thickness of less than 0,5 -10 3 m, preferably less than 0,3-10 3 m. 5. A device according to claim 1 -4 CHARACTERISED IN that the means comprises a layer of a material secured to a distal string. 6. A device according to claim 5 CHARACTERISED IN that the material is a soft non-woven. 7. A device according to claim 5 CHARACTERISED IN that the means comprises one or more loops formed on the string. 11 8. A device according to claim 7 CHARACTERISED IN that the length of the part of the string (2) forming a loop is at least 6 times the thickness of the string, preferably at least 9 times the thickness of the string. 9. A method for making a device comprising a body made of an elastic moulded material and at least one string secured to the body which method comprises the following steps: a) holding means are secured to or formed on at least one first string, b) this string(s) alone or connected to one or more second string(s) is/are positioned in a moulding form where at least one first string exits the distal part of the mould and at least one second string exits the proximal end of the moulding form, c) the raw materials are prepared and the moulding form is filled, d) the material at least partly hardened, e) the device is removed from the form, f) the device is optionally dried. 10. A method according to claim 9, CHARACTERISED in that the string(s) which exit(s) the proximal end of the body of the device is(are) cut off at the surface of the device. 11. A method for making a device according to claim 9 or 10, CHARACTERISED in that at least the first string(s) exiting the distal end and at least one second string exiting the proximal end are connected and positioned in the moulding form. 12. A method for making a device according to claim 11 , CHARACTERISED in that at least a first string and at least one second string is tied together in such a way that at least the first string forms a loop and the at least two strings are connected to each other, whereafter the at least two strings are positioned in a moulding form where the first string exits the distal part of the moulding form and the second string exits the proximal end of the moulding form. 12 13. A method for making a device according to claim 11 or 12, CHARACTERISED in that the first string(s) with at least one loop has a minimum total thickness of 0,5 -10 3 m, preferably of 0,9-10 3 m, and the second string(s) has a maximum total thick- ness of 0,5- 10 3 m, preferably 0,3- 10 3 m. 14. A method for securing a string in a device for insertion into a body orifice which device comprises a body having a distal and a proximal end and being made of an elastic and moulded material, and at least one string which is secured to the body during moulding wherein a first string is provided with holding means and is placed in a mould for preparing the device in such a manner that it exits the distal part of the mould and filling the mould with the material forming the device embedding the string.

Inventors: JENSEN HANNE, NIELSEN HENRIK LINDESKOV, SVENNINGSEN IRENE, JENSEN, HANNE, NIELSEN, HENRIK, LINDESKOV, SVENNINGSEN, IRENE
Applicants: COLOPLAST AS, JENSEN HANNE, NIELSEN HENRIK LINDESKOV, SVENNINGSEN IRENE, COLOPLAST A/S, JENSEN, HANNE, NIELSEN, HENRIK, LINDESKOV, SVENNINGSEN, IRENE
Application year: 1999
Main classification: A61F2
IPC codes: A61F2, A61F5, A61F13