DEVICE FOR SEALING BODILY ORIFICES, WITH NEUTRAL WEARING COMFORT

Abstract

The invention relates to a device for the optimal organ-tolerable sealing, with minimal irritation, of bodily orifices, said device consisting of an extremely thin-walled, externally fillable balloon body having a central tube piece connecting the interior of the intestine to the perianal region of the anus, the tube piece being made of a soft-film-type material with a low volumetric expandability, wherein in a preferred design, one end of the balloon, which during the production process is completely formed to its required final dimensions, is reverse folded through the other end, and both balloon ends are tight-fittingly interconnected in the region of the outer bodily orifice and a thin-walled, adhesive-coated soft-film proximally adjoins the connection region of the two balloon ends, allowing direct fixation of the device to the skin and thus completely eliminating rigid, potentially irritating components in the region of the anal canal and in the perianal region.

Claims

1. A device for (1) for the optimal organ-tolerable sealing, with minimal irritation, of a lumen (L) leading as an ostium in the region of the surface of the body, in particular a natural or artificial anus (A) of a patient, consisting of an extremely thin-walled, externally fillable balloon body (2) made of a soft-film-type material with a low volumetric expandability, which has a central lumen, which extends from the distal to the proximal end of the device (1), characterized in that a) the central lumen inside the balloon body (2) is not surrounded by a shaft, so that rigid, potentially irritating components in the region of the ostium as well as in the adjoining, extracorporeal region can be completely eliminated, and that b) at least one flat retaining shoulder (3) coated with a skin-tolerable adhesive adjoins the proximal end of the balloon body (2) allowing a direct fixation of the device (1) to the skin of the patient.

2. The device (1) according to claim 1, characterized in that, during production, the balloon body (2) is completely formed to its required dimensions.

3. The device (1) according to claim 1, characterized in that the cavity of the balloon (2) towards the surrounding lumen is completed by a layer of a soft-film-type material.

4. The device (1) according to claim 3, characterized in that the layer of soft-film-type material delimiting the cavity of the balloon (2) towards the surrounding lumen is connected to or integrally formed with the outer sheath of the balloon body (2).

5. The device (1) according to claim 1, characterized in that, to produce the balloon body (2), one end (2a) of a balloon blank that is tube-shaped to begin with is inwardly everted and guided through the other end (2b) of the balloon blank.

6. The device (1) according to claim 5, characterized in that the two ends of the balloon (2a, 2b) guided into each other are connected to each other in a tightly sealed manner, in particular in the transostial or in the transluminal region or in the directly adjoining extracorporeal region, in order to thereby produce an externally fillable space.

7. The device (1) according to claim 6, characterized in that the two ends of the balloon (2a, 2b) guided into each other are directly connected to each other, i.e., not via a sleeve interposed therebetween or another spacing element.

8. The device (1) according claim 1, characterized in that, as the case may be, existing, extracorporeal regions of the balloon body (2) are not expanded radially with respect to the transostial balloon section.

9. The device (1) according to claim 1, characterized in that the balloon body (2) is produced by blow molding, in particular by blow molding from a thermoplastic polyurethane film.

10. The device (1) according to claim 1, characterized in that the retaining shoulder (3) consists of a thin, preferably membrane-like soft film.

11. The device (1) according to claim 1, characterized in that the retaining shoulder (3) consists of thermoplastic polyurethane.

12. The device (1) according to claim 1, characterized in that the retaining shoulder (3) is produced by deep drawing.

13. The device (1) according to claim 1, characterized in that the retaining shoulder (3) is coated with a gel-like material layer based on polyurethane for example.

14. The device (1) according to claim 5, characterized in that the retaining shoulder (3) has one or more flaps or wings projecting approximately radially away from the proximal end of the balloon (2a, 2b), in particular a flap-like, wing-like or propeller-like base area.

15. The device (1) according to claim 1, characterized in that the retaining shoulder (3) has a symmetrical base area, in particular with two projections (16) lying approximately diametrically opposite from each other.

16. The device (1) according to claim 5, characterized in that the retaining shoulder (3) attaches directly to the connecting region (2c) of the two ends (2a, 2b) of the balloon film.

17. The device (1) according to claim 5, characterized in that the retaining shoulder (3) molded on or formed in a merging manner in one of the ends (2a, 2b) of the balloon body (2).

18. The device (1) according to claim 1, characterized in that the retaining shoulder (3) is produced as a separate film element.

19. The device (1) according to claim 1, characterized in that the retaining shoulder (3) has a neck-like or cone-like extension (3b) oriented towards the ostium or even reaching into the ostium or lumen, which facilitates a simple, precisely fitting joining on the concentric tube layers (2a, 2b) of the balloon body (2).

20. The device (1) according to claim 1, characterized in that the retaining shoulder (3) is connected to the balloon structure (2), however, without the use of an especially rigid connecting or functional body.

21. The device (1) according to claim 1, characterized in that a connection (2c) between the balloon body (2) and the retaining shoulder (3) is produced by adhesion or welding.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Additional features, advantages and effects based on the invention are found in the following description as well as based on the drawing, which discloses preferred embodiments of the invention and shows:

[0018] FIG. 1 A completely folded back, shaft-less balloon body with a retaining film attached for the extracorporeal adhesion to the balloon body, using the example of a natural anus;

[0019] FIG. 2a A device corresponding to the embodiment in FIG. 1, wherein the distal end of the balloon is equipped there with a fixed olive-shaped insertion element as well as a retractable insertion aid;

[0020] FIG. 2b A device that corresponds in terms of its structure to that of FIG. 2a, wherein the distal end of the balloon integrates a finger cot-like insertion element;

[0021] FIG. 2c A modification of the design according to FIG. 2b, wherein the device is likewise picked up by the user's finger and thereby inserted digitally;

[0022] FIG. 3a The transition of the balloon film into the retaining film as a part of an exemplary embodiment;

[0023] FIG. 3b A further embodiment of the film transition;

[0024] FIG. 4 A combination of the retaining film with a gel-like substance modifying the haptics of the retaining film;

[0025] FIG. 5 A special, propeller-shaped embodiment of the retaining film for the fixation of the sealing device on the perianal skin of the inner surfaces of the buttocks;

[0026] FIG. 5a Special substrates affixed to the skin of the inner surfaces of the buttocks, on which the propeller-shaped or strip-shaped retaining films of the sealing device, which can be changed intermittently, can be fixed in an adhesive and reversibly detachable manner;

[0027] FIG. 5b A special embodiment of an insertion aid for determining the correct anorectal insertion depth and for simplified affixing of the lateral wings or extensions on the perianal skin or substrate;

[0028] FIG. 5c A further view of the insertion aid shown in FIG. 5b;

[0029] FIG. 6 A corresponding embodiment for the intermittent, sealing seal of an artificial anus (stoma); as well as

[0030] FIG. 6a An adhesively applied substrate that is cut to be circular or tire-shape for example for use with ileostomies.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0031] FIG. 1 shows a device 1 according to the invention, in particular in the form of an anal seal, consisting of a balloon body 2, whose two ends of the balloon 2a and 2b run parallel to each other and due to a corresponding equalization of the respective terminal diameters are tight-fittingly interconnected in the region 2c, forming a space that is fillable with a preferably gaseous medium, as well as furthermore consisting of an adhesively acting retaining film 3, which fixes the sealing device perianally on the inner sides of the buttocks of the patient and is thereby meant to prevent an undesired luxation of the device out of the trans-anal positioning, which acts in a sealing manner and is characteristic for the invention, into the rectum, such as is regularly observed without corresponding perianally fixing components, in particular when transitioning from a standing into a sitting posture of the patient.

[0032] The retaining film 3 connects directly and without a connecting or intermediary element to the proximal end of the filling body defined by the region 2c. The retaining film has an adhesive area 3a oriented towards the patient. It has a neck-like deep drawing 3b, which overlaps congruently with the inner or outer surface of the region 2c and is directly connected therewith by means of adhesion or welding. In the joining region 2c of the two ends of the balloon, a tube supply line 4 filling the balloon body is inserted in a sealing manner between the two concentric film layers or even tube layers, and a pilot balloon 5 with an integrated filler valve is attached on the end of said tube supply line.

[0033] The positioning of the seal in or on the patient takes place in such a way that the two concentrically running ends of the balloon 2a and 2b run through the anus A and the toroidal balloon body 2 rests on the base of the rectum R. The trans-anal segment of the balloon body yielded by the two ends of the balloon is tapered in diameter relative to the rectally positioned torus. The diameter of the end of the balloon 2b is configured to be preferably approx. 15 to 30 mm, especially preferably to be 20 to 25 mm. The diameter of the inside end of the balloon 2a is at approx. 15 mm and in an ideal case allows the accommodation of the device on the user's finger or the digital trans-anal insertion of the balloon body. As an alternative to an end of the balloon 2a emerging directly from the balloon or being formed in one piece, the central lumen L, which continuously connects the distal end of the balloon to the proximal end of the balloon, can also be produced by a separately produced tube segment 9.

[0034] The balloon body is preferably filled incompletely in situ. The filling volume used is approximately 80% of the volume of the freely formed or freely developed balloon body. The balloon thus merges into a flaccid, tensionless filling level that is especially advantageous for the functioning of the device. In a flaccid state, the balloon body absorbs the respective prevailing rectal force, but does not itself transfer any permanently acting force to the anatomical structures and tissue adjacent to it. The filling pressure prevailing in the balloon behaves almost time synchronously to the pressures acting rectally or abdominally, and thus guarantees a continuously acting, sealing development of the trans-anally positioned outer end of the balloon 2b, which development is oriented towards the mucous membrane of the anal canal. In the meantime, due to the action of force of the filling pressure prevailing in the balloon body, and provided there is a corresponding deformability, the central lumen L formed by the inner end of the balloon 2a, collapses in a manner that almost seals the lumen.

[0035] FIG. 2a shows an embodiment of the device corresponding to FIG. 1, wherein an olive-like insertion element 6 is firmly inserted into the distal or front opening of the lumens L, which insertion element has a central canal 7, into whose proximal end a rod-like insertion aid 8 that can be retracted out of the olive is inserted. The inner layer 2a of the device can alternatively be produced as a separately formed tube film element 9, which attaches proximally to the olive, and connects in a tightly fitting manner in the region 2c to the outer layer 2b.

[0036] The insertion aid 8 can be provided with a discoid and/or plate-like element 8a, which through a mechanical limit stop of the discus on the anus, indicates the correct insertion depth to the user for inserting the device. In doing so, the retaining film 3 rests distally on the element 8a, i.e., oriented towards the patient.

[0037] FIG. 2b shows a design corresponding to FIG. 2a, wherein a finger cot-like element 10 is inserted into the distal opening of the lumen L in a firmly connecting manner, into which finger cot-like element the distal phalanx of the inserting finger can be inserted. The finger cot 10 is provided preferably with an opening 11 on the distal end for the decompression of intestinal gas. The opening can be provided with a gas permeable, but liquid repellent fleece.

[0038] FIG. 2c shows a design corresponding to FIG. 1 and FIG. 2b, wherein a narrow section 12 is formed in the distal region of the lumen L in the inner layer or the inner end of the balloon 2a, which also allows the insertion of a finger holding the device. The lumen 13 in the region of the narrow section allows for the continuous outlet of intestinal gas.

[0039] FIG. 3a shows the transition of the ends of the film of the balloon body into the pre-anally retaining balloon film 3 in detail. In the region 2c, the neck-like or funnel-like extension 3b of the retaining film adjoins from the outside or from the inside. The transitional region is preferably placed in the outer third of the anal canal A. The especially pressure-sensitive rosette of the anus is thereby exposed merely to the retaining film 3, and not to the joining region of the ends of the balloon with the retaining film. The neck-like extension 3b of the retaining film can be formed into the film during production, e.g., by a corresponding deep drawing method.

[0040] FIG. 3b shows further embodiment options of the transition from the balloon film and the retaining film. Thus, a flange-like extension 2d can be formed on the proximal end of the inner end of the balloon 2a, on which extension the retaining film 3 is in turn flange-mounted. The flange 2d should have a diameter of approx. 4 to 5 cm in order to guarantee that the two-layer connection surface of the connecting region is positioned at an adequate distance from the rosette. Alternatively, the flange 2d can be formed to be so large in diameter that it no longer needs any further retaining film 3 and the adhesive 3a can then be applied directly to the inner side of the flange oriented towards the patient. The adhesive surface, which is coated with adhesive, should have at least a distance of 15 mm from the edge of the anal rosette.

[0041] FIG. 4 shows a special combination of the retaining film 3 with an adhesively acting, gel-like substance, which can be applied either to the side 14 facing the patient or to the side 15 facing away from the patient. If the gel is pointing toward the patient, adhesive properties can be achieved with polyurethane-based gels for example that are adequate for the adhesion of the device to the skin of the patient. The advantageous effect of the gels consists of its tissue-like quality and a good, less irritating skin tolerability. If the gel is applied to the side facing away from the patient, both the manual application as well as the detachment or removal of the retaining film from the skin by the patient can be facilitated by a corresponding gel-like surface or partial surface. For this purpose, the gel is provided on the side facing away from the patient with a suitable coating or enclosure 15a, which uses the natural adhesion of soft PUR gels.

[0042] FIG. 5 shows a propeller-like retaining surface 16 that is cut especially advantageously for less irritating wearing comfort, whose two wings are respectively affixed to the perianal skin of the buttocks adjacent to the rosette. The center especially narrow portion 17 lies immediately in front of the anus. Because of the narrowing of the lateral wings towards the center portion 17, shearing or twisting effects of the buttocks can largely be prevented when moving towards the portion of the sealing device that is positioned anally or trans-anally. The decoupling of gluteal movements or mass movements of the body from the retaining and sealing balloon body is crucial for a most neutral possible wearing sensation for the user.

[0043] FIG. 5a deals in particular with the comfort when detaching the adhesive retaining film from the patient. In order to prevent a painful detachment of the adhering film from the sensitive perianal skin, flat substrates 16a are affixed perianally to both parts of the gluteal skin, said substrates consisting of a preferably transparent film material that is suitable for a sustained skin exposure. For the substrates, the invention prefers adhesive films with properties such as those that are offered for example by the manufacturer, 3M Health Care, in the form of the Tegaderm Absorbent product. The product has a central, flat section which has a prominent wall thickness and increased rigidity towards the surrounding edge, and thereby facilitates the tactile perception of the region of the substrate that is especially favorable for anchoring the retaining film. If the user has a direct view of the perianal region when inserting and fixing the balloon seal, for example by using a mirror, the relative positioning of the retaining film on the substrate is furthermore facilitated by a coloration of the substrate 16a in the region of this favorable positioning.

[0044] The described adhesive film substrate 16a consists preferably of a hydrocolloidal, breathable material, is waterproof and permits both regular showering and a normal anal toileting. Due to the transparency of the material, reactive changes to the skin can be detected easily, as the case may be.

[0045] The propeller-shaped or even strip-shaped retaining films 16 are affixed to the two substrates 16a, which can remain positioned perianally over several days and up to a week. In the process, the adhesive effect of the substrate 16a on the skin of the patient is greater than the adhesion of the retaining film to the substrate. Furthermore, the contour of the substrate 16a should overlap the contour of the extensions 16 of the retaining film 3 being fixed, in order to thereby guarantee that the retaining film takes place on the substrate with a certain degree of security during application by the patient. For technology of this sort, in particular polyurethane-based gels that are applied in very thin layers and permit for instance a Post-it Note-like removal effect from the underlying film are suitable for an adhesive for fixation between the retaining film 3 and the substrate. An overall moderately effective adherence to the described film substrate is adequate for preventing the described luxation of the sealing device out of the trans-anal position into rectum.

[0046] To facilitate the detachment of the propeller-shaped or strip-shaped retaining film from the substrate, the ends of the film extensions 16 are provided with a non-adhesive film region 16b, which can be easily grasped by the user.

[0047] FIG. 5b shows a special design of a sealing device according to the invention, wherein the sealing body to be positioned rectally and trans-anally is placed on a finger-like element 8b, and the insertion depth is predetermined for the user by a flange-like, plate-like or discoid limit stop 8a. In the proximal direction, oriented away from the patient, the finger-like element merges into a hand grip 8c, which makes the manual insertion into the anus easier. The limit stop has two mutually oppositely disposed recesses 8d, into which the retaining films 16 to be affixed to the buttocks are inserted parallel to the hand grip. The inserting hand thereby grasps the hand grip together with the retaining films, whereby the retaining films do not hinder the anal insertion of the device. After the discus determining the insertion aid makes impact with the anus, the retaining films 16 are folded out of the recesses 8d and, after a protective film is removed or peeled off, they are affixed to the buttocks. The finger-like element 8b is then pulled out of the central lumen L of the balloon body and removed.

[0048] FIG. 6 shows a special design of the retaining film 3 for the sealing of artificial anuses, in particular of so-called ileostomies, which establish a direct connection of the small intestine of a patient to the abdominal skin surface. The retaining film 3 or 18 in this case is extended in a depressed and bell-like manner. The depression accommodates the intestinal segment S of the stoma that is folded over on the abdominal wall and adheres there. The outer side of the film 3 in this case can be surrounded by a protective gel layer 19, which optionally lies cap-like or dome-like 19a over the external stoma, or follows and nestles against the bell-shaped contour 19b of the film.

[0049] FIG. 6a shows a stoma-compliant variant of a substrate 16a, which facilitates the detachment of the sealing device from the peri-stomal skin. In this case, it is cut out to be circular and consists preferably of a very thin-walled, breathable, waterproof and washable film, which is analogous to the substrate described in FIG. 5a. The substrate allows the sealing body that is positioned in the stoma to be detached from the perianal skin in a manner that is atraumatic and free of plain. The substrate is manufactured in various circular opening diameters 16c. It also has a non-adhesive edge section 16b, which can be grasped safely by the patient and allows the foil to be peeled off of the film.

[0050] The balloon body is preferably filled with a specific, predetermined air volume. To this end, the user uses a conventional syringe for example, which is provided with a corresponding volume mark. The volume for the filling of the balloon body is determined in such a way that the balloon fills only partially, and thus remains in a flaccid, tensionless state. In situ the balloon filled in this manner nestles against the individual anorectal anatomy of the patient in an optimally sealing manner. The filling pressure that respectively adjusts in the balloon corresponds in an approximate way to the respectively prevailing rectal pressure. This is normally achieved with the fill volume that corresponds to approx. 70 to 80% of the freely formed balloon body of the application-ready device.

[0051] As an alternative, the sealing device can also be adjusted in a pressure-controlled manner with a customary manual pump pressure gauge for example. The pressures that are required for the sealing function must then be determined individually.

TABLE-US-00001 List of Reference Numbers  1 Device  2 Balloon body  2a End of the balloon  2b End of the balloon  2c Region, joining region  2d Flange-like extension  3 Retaining shoulder  3a Adhesive area  3b Funnel-like extension  4 Tube supply line  5 Pilot balloon  6 Insertion element  7 Central canal  8 Insertion aid  8a Plate-like element  8b Finger-like element  8c Hand grip  8d Recess  9 Tube segment 10 Finger cot 11 Opening 12 Narrow section 13 Lumen 14 Side 15 Side 16 Retaining surface 16a Substrate 16b Film region 16c Opening diameter 17 Portion 18 Retaining film 19 Gel layer 19a Dome, cap 19b Bell-shaped contour A Anus, anal canal L Lumen R Base of the rectum S Intestinal segment