Summary of the invention
Task of the present invention is, improves a kind of device nature or synthetical anus that is used to close like this, makes under the situation do not remove the intestinal stopper again emptying intestinal continuously.
In order to solve this task, the present invention's regulation, the cover of putting more energy into so is inserted in the outer field zone near patient, makes the layer that runs through of its inside by gas cell separate with hollow space in gas cell inside completely.
Therefore this cover keeps opening enduringly near the inner chamber in patient's the zone of gas cell, and therefore is easy to the emptying of intestinal.In contrast, running through anal region can close also and can open in the mode of valve.
Within the scope of the invention, at the described material hardness H that test is determined according to Xiao A hardness that runs through the described pipeline section in the anal region
1Greater than 70, be preferably more than 80, so can make on the one hand by extruding, and on the other hand when gas cell inflate expansion occur in can estimate with limited degree in.
The wall thickness of gas cell, special wall thickness in its outer field zone is less than 50 μ m, preferably less than 40 μ m, especially less than 30 μ m.Although so quite high material hardness H
1Still there is enough ductility, so should can fold into minimum cross section during inserting and between the drainage stage in the zone.
The present invention advises using polyurethane to be used to form the pipeline section of gas cell.On the other hand, this material has necessary material hardness and can be pre-formed into the degree of expectation; And it can be with extremely thin wall thickness manufacturing.
The material hardness H effectively verified, that the with good grounds Xiao A hardness test of the described tackling of putting more energy into is determined
2, this hardness is equal to or less than the material hardness H that test is determined according to Xiao A hardness that runs through pipeline section described in the anal region described
1Cover is configured to obvious thicklyer than gas cell owing to put more energy into, and it often remains on patient's rectum the inside 30 days or more days with gas cell in addition, so it should be too firmly not avoid stimulating or injuring fully the enteral mucosa.This can pass through the hardness H of the restriction of cover material
2Realize.
A kind of selection is that described pipe and the described cover of putting more energy into are made by identical materials.Because the processing identical materials, the machining cost reduces significantly usually; In addition, bonding also can easily carry out and under many circumstances by two parts that will be joined together slightly, temporary transient dissolving, be used for the solvent of described material.Therefore abandoning expensive gluing prepares.
Advantageously verified, described wall thickness and hardness of putting more energy into cover is so selected, and makes aforesaid element radially to compress to be inserted in the rectum.The actual hardness that these two parameter influences are put more energy into and overlapped, for example mode to double.The material that this means the cover of putting more energy into is hard more, and its wall thickness structure is thin more so, and vice versa.
The described cover of putting more energy into is not attached on any end of the pipeline section that forms described gas cell, thus it can carry out the front near any motion of patient's gas cell part.Therefore this balloon segment maintains high degree of freedom and can outwards and/or backward roll, and this expects in this case, describes as also continuing below.
The following further improvement of thought of the present invention, make to form the end of pipeline section of described gas cell or preferred two ends be arranged on described run through anal region or cross its be provided with.Therefore these two ends of pipeline section are positioned at the rectum outside, so this zone is easy to reach and do not produce the problem of sealing.
Preferably, the cover that is connected at least one end of the pipeline section that forms described gas cell constitutes extracorporeal connecting element.So different apparatuses can be connected on this connecting element, for example flusher, lead to conduit away from patient's container etc.
Volume in the sealing of described gas cell inside can pressurize from the outside, can on purpose influence its geometry like this.
According to the present invention, be provided with the passage that is used for the emptying intestinal that surrounds by gas cell, but wherein the volume of on-load pressure by two about mutual concentric surf zones restrictions of gas cell.Therefore can abandon bar or analog fully; Its function is born by the concentric layer of gas cell fully.
In the further practice of inventive concept, stipulate in addition, in order to guarantee in described device remains in zone in the anus catheter, to stay open, the inner surface section point-like of described gas cell ground, wire ground or planar the outer surface region that is connected to described gas cell are for example by welding or bonding.Under such situation, interior inflation cystoblast or pipe layers are fixed on the skin.
The invention is characterized in addition, be used to close the obstruction gas cell of described emptying passage.Such obstruction gas cell is fixed in the zone of central lumen of original gas cell and can separates expansion with original gas cell, for example by supply line separately, by this supply line preferably gaseous medium enter into and stop up gas cell.
Described obstruction gas cell preferably is positioned in the described cover of putting more energy into, there its open channel when dwindling.
The present invention also stipulates in addition, and described obstruction gas cell is by thin-walled, and suitably preformed material is made.Therefore the shape of obstruction gas cell can quite accurately be stipulated when expanding, and is used to launch the desired pressure of gas cell and can keeps quite low, because needn't produce any elastic expansion of gas cell material.
In the scope of alternative form of implementation of the present invention, described obstruction gas cell is stored elastic compartment fully and is formed by can be formed in the described gas cell.This is possible, is positioned at according to not contacting with people's tissue in the central lumen of device of the present invention and therefore, so even internal pressure is very high, also can not cause the damage of human tissue because stop up gas cell.
Stipulate highly beneficially, in the zone of the described cover of putting more energy into, be provided with the flushing opening, this flushing opening be connected along the conduit that runs through anus section formation and be used to introduce flushing liquor.By this way, coloclysis at any time under the situation of not removing device of the present invention.
If be used to introduce the described conduit of flushing liquor extend to the front near patient's gas cell convex shoulder, during coloclysis, will not have antibacterial to enter enteral so, but flushing liquor directly enters into enteral under without any situation about polluting from running through anal region.
The present invention also further optimizes by the radial expansion portion in running through anal region.This extension also should be used as the corresponding piece of the collision of the gas cell shape in the internal rectum pipeline section.Its task is, when pull strength that balloon inflated produces, the outside that anal region to small part remains on anus of running through that keeps this device is so device of the present invention has the position of restriction.
For this reason, the skin that forms the pipeline section of described gas cell has the preform of the extension of directed outside in running through anal region.Thereby the corresponding preform section of gas cell itself is formed for the adjacency section along the axial force of anus direction of being expanded and being applied by intrarectal gas cell shape.
In favourable improvement of the present invention, has the geometry of annular or dish type at the described outer field preform that runs through the directed outside in the anal region of described gas cell.Therefore with irrespectively set up the relation of always optimizing according to the turned position of device of the present invention.
Possible on the other hand is, has a finger piece or two the about diameters geometry to finger piece separated from each other at the described outer field preform that runs through the directed outside in the anal region of described gas cell.These digitation portions can be placed in the buttocks pleat so that the degree of comfort maximization of wearing.
In addition, the skin setting of the pipeline section of wedge-shaped element by forming gas cell particularly is fixed on and describedly runs through in the anal region or from running through anal region to the transition region of connecting element.Same this foam element can be as the adjacency section and is had the higher rigidity that can produce very good positional stability in addition.
The specific embodiment
Device of the present invention according to Fig. 1 and 2 is used to seal natural or synthetical anus.It comprises pipeline 2 preformed and that turn up, and this pipeline is made by thin-walled material, for example by ShoreA (Shore A) hardness be 90 and wall thickness make less than the polyurethane of 25 μ m.
The pipeline 2 of primary diameter between about 15mm to 30mm is provided with two radial expansion portions 3,4 during preform.A preferred bigger extension 3 is positioned at about centre of pipeline, this extension after turning up constituent apparatus 1 near patient's end.Another preform 4 approximately is located at after the upset centre of pipeline section 5 outside, yet the pipeline section 6 that is positioned at the inside does not have the extension, but has constant cross section.
Two free ends 7,8 of two pipeline sections 5,6 are connected in the connecting element 9 of sleeve shaped.Connecting element 9 (special in its zone away from patient end) can have female thread or external screw thread, is used to connect for example different medical apparatus of refuse bag, conduit etc.
Preferably, the skin 5 of gas cell 2 is adhered to the outside of sleeve shaped connecting element 9 regularly, and the internal layer 6 of gas cell 2 is bonded in the inside regularly.Therefore the hollow space between the internal layer 6 and outer 5 of gas cell 2 seals airtightly; Only have not shown outside joint in the zone of connecting element 9, the source with the medium that can exert pressure can be connected on this joint, so that launch gas cell 2.
Because the material hardness that gas cell 2 is bigger, it only has slight elasticity and present as can be seen from Fig. 1 the profile that preform is stipulated of passing through under expansible state.This profile comprises about columniform basic configuration, and described basic configuration has near patient's and with respect to the extension 4 of the about spheric extension 3 on the end of connecting element 9 and annular on the emphasis between two ends 3,9 or dish type.
Spherical expansion portion 3 is placed into patient's internal rectum (rectum inner segment) under deflated state, and the cylindrical segment 11 of the extension of following that always extends to annular or dish type 4 leads to outside (running through anal region) by anus catheter, the extension 4 in patient distally only is positioned at the anus front, in preanal buttocks pleat.
Running through in the anal region 11 between two extensions 3,4, the two-layer i.e. skin 5 and the internal layer 6 of gas cell 2 are interconnection, preferably by weld 12 or bonding connection.These junctions relate to a shape, linear or face shape welding here.In an illustrated embodiment, be provided with four sealing wires 12 that in axial direction form, these sealing wires always are offset approximately identical circumference angle mutually.Utilize these solder bond 12, when intestinal was drained, the inner chamber 13 in internal layer 6 inside of gas cell 2 can easily be opened.
If at rectum the contractile motion of the muscular tissue of rectum takes place between removal period by the light of nature, consequent power is received by intrarectal gas cell section 3.The pressure that produces in whole blockage element 1 raises and causes running through the effectively stretching of anus section 11 and 5, and running through of deriving simultaneously, anus inner chamber 13 was widened and show in its entire cross section when the correspondingly bigger rising of gas cell stuffing pressure.Additional advantage from internal rectum to this motion that runs through pressure the anus section and volume is, runs through effectively not twining or not reversing of anus section.Do not having under such mechanism's situation of not twining, because in the axial torsion in the anus section of running through of this device, thus have no idea to guarantee reliably that inner chamber can not become closes, thus function damaged.User also can on purpose be regulated the opening of anus catheter of the defecation process that can support instinct effectively.If for example carry out the flushing (coloclysis) of intestinal in advance, during flushing process, suitably be increased in the blowing pressure in the device 1 so.Multiple in this case feature capability parts are advantageously cooperated.The directed vertically motion of internal rectum gas cell parts causes intrarectal inflation utricule 3 consistent with anus to be closed nattily, and it is preanal in abutting connection with gas cell 4 to support the anus pulling from the outside with the power that equates simultaneously; In addition, the drainage inner chamber that runs through anus section 5 and 11 becomes straight line and all unclamps around any distortion of the longitudinal axis of this device.
In the scope near patient's extension 3, inner inner chamber 13 stays open by the cover 14 of putting more energy into, and described length of putting more energy into cover preferably is equal to or less than the extending axially of radial intrarectal extension 3 of gas cell 2.Cover 14 the material hardness of putting more energy into preferably is equal to or less than the material hardness of gas cell; The wall thickness that cover 14 increases from it obtains its rigidity.Be preferably used for overlapping 14 identical materials and can be used in pipeline or gas cell 2.Therefore overlap 14 and can easily be fixed in the inner inner chamber 13, cling by the internal layer 6 with gas cell 2 especially, the medium that wherein dissolves relevant material under these circumstances slightly can or be used for welding as binding agent.
Pipeline 15 preferably in inner chamber 13 from extend to the far-end of connecting element 9 near patient's end 3.Be fixed on the pipeline 15 of (preferably on internal layer 6) on the gas cell 2 by for example adhesional energy, enema can be incorporated in patient's the intestinal.Therefore under these circumstances, from running through anal region 11 or can entering into intestinal from the antibacterial in the zone that surpasses the extension 4 of running through anus, the opening of pipe 15 is not arranged in the top zone of the internal rectum end 3 of device 1.Pipe 15 can pass the inboard of the cover 14 of putting more energy into or be passed in and put more energy between cover 14 and the internal layer 6.
In order during coloclysis, to pin rectum inner chamber 13, also can be provided with and stop up gas cell 16 in the mode of the best.This obstruction gas cell is preferably located in puts more energy into cover 14 inside and has its diameter slightly greater than the spherical preliminary shape of the diameter of the cover 14 of putting more energy in the form of implementation according to Fig. 1 and 2.Therefore expansible obstruction gas cell 16 is closed rectum inner chamber 13 fully and is born pressure on the inboard of cover 14 of putting more energy into and less distortion, thereby closes it.
Another pipe 17 is passed into and blocks gas cell 16, can import to by the preferably gasiform pressure medium of this pipe and block in the gas cell 16, so that close inner chamber 13 in the zone of cover 14 of putting more energy into.The pipe 17 on the inboard of gas cell internal layer 6 up to passing connecting element 9 and can reaching from the outside.Be passed in the zone of stopping up gas cell 16 about pipe 17 greatly, stop up gas cell and be fixed on the cover 14 of putting more energy into, for example bonding in the mode of about point-like.
Form of implementation 1 among Fig. 3 ' with the difference of aforesaid form of implementation only be to stop up gas cell 16 ' another kind of structure.A kind of form of implementation 1 in back ' in this obstructions gas cell have the structure of short pipe 18, about with put more energy into that to overlap 14 diameter and length identical.This pipe 18 can be pre-formed into the form of expanded radially in its axial interlude.The two ends of this pipe 18 are fixed on the inboard of the cover 14 of putting more energy into, and for example being clipped in puts more energy between the cover and respectively hold is inserted in the cover 19.Cover 19 can be additionally be fixed in the cover 14 of putting more energy into and forms construction unit then with it by glue in two.If the fill fluid of clamping region and the hollow space 16 between the cover 14 of putting more energy into ' from the outside not in pipe 18 centre is managed 18 so and curved inwardly, as shown in FIG. 3, and close inner chamber 13 in the mode of iris.In order to use fluid filled, the cover of putting more energy in this case 14 is provided with conduit 20, this conduit from away from the distolateral of patient until in two, run through the described cover of putting more energy into the zone between the cover 19, and inwardly injection there.Pipe 17 ' be communicated with conduit 20.