DE102016006898A1 - Device for wound healing promoting closure of fistulous body openings - Google Patents

Abstract

The device described describes a device for closing a fistula-like connection between a body cavity and the body surface, wherein the occlusive or tampon-effecting balloon or hose body consists of an extremely thin-walled, already in the production of their working dimension or beyond shaped envelope body, preferably a Has pearl necklace-like sequence of extended and tapered areas and due to the so possible, vorformungsbedingten, an elastic expansion of the sheath material avoiding, low inflation pressures has a perfusion-compatible, efficient space-filling effect within complex-shaped fistula tracts. With only partial occlusion of the fistula tract, a negative pressure-loaded space can be produced between the terminal, sealing elements of the device, which dissipates wound secretions and is separated from the secretions of the cavity / hollow organ connected to the fistula.

Description

The supply of fistula-like connections between a hollow organ of the digestive tract and the body surface of the patient can be a very difficult and nurturing task. In particular, in fistulas that are highly secretive, successful wound management in many cases, even with advanced techniques, is difficult to produce. In many cases, the fistula-causing inflammatory process is preserved and a progressive decrease in inflammation or healing of the fistula tracts is unequaled.

It would be desirable to have a care concept that stops, discharges or tampons the fistula as completely as possible, avoiding the use of tissue-incompatible forces or behaving in as body-friendly a manner as possible, able to follow the movement of the patient as well as possible optimally little irritated.

A particular challenge in the sealing occlusion of a fistulous tract of inflammatory genesis is the often irregular irregularly shaped structure of the canal, with partially changing, narrow canal-like areas and cavity-like hollowed-out sections. The fistula-causing, usually persistent inflammatory processes also require a closure or tamponade technique that pollutes the circulation of the inflamed tissues with the least possible force and thus does not affect their healing.

Another problem is the anchoring of a fistula occluding or tamponizing body in situ. A moving patient, with permanently changing relative positions of the fistula entrance and fistula exit, makes the seal-efficient fistula closure difficult using conventional delivery techniques.

An effective option in the treatment of fistulae are so-called vacuum or vacuum bandage techniques. In this case, secretion is continuously removed from the fistula cavity by applying a sustained, moderate negative pressure, whereby the wound healing or the desired fistula closure is promoted. However, if a fistula communicates with a secretory hollow organ, such as the small intestine, there is a build-up of negative pressure in the fistula area or outside the body or immediately in front of the fistula, from the attachment of a septum aspiration-preventing, separating closure between the hollow organ and the vacuumized one Area dependent. Only then can the sustained discharge of secretion into the fistula be prevented under the conditions of an applied vacuum.

In other cases, however, may be the discharge of secretion out of the hollow organ, through the vacuumized fistula passage, be required. Such discharges are required, for example, if it is an isolated space inside the body that has no natural drainage path or whose drainage path is closed.

The following invention describes technical solutions for closing fistula-like structures as gently as possible, tamponing or draining, for example by applying a negative pressure. The presented technique is based on preferably extremely thin-walled balloon or tubular casings, which nestle as far as possible in space, with the least possible residual space remaining, into the fistula space or fill it. The thin-walled hose or balloon structures are preferably segmented in a bead-like manner, ie they have areas which are already formed completely in the form of disc-shaped or spherically-extended segments during manufacture, with respective regions narrowed in a tubular manner. This construction ensures in a special way that the occluding or tamponizing device can develop as much as possible into the fistula space or position itself there, that it is possible to intercept relative movements between the device and the fistula wall and the estuarine areas of the fistula as far as possible without irritation, and the fistula space to be filled in each case as far as possible without remaining space can fill.

In particular according to the invention in their radial dimensioning oversized mikrodünnwandige closure devices are used, which are able to record residual envelope wall in fold-like invaginations, the self-adjusting convolution, due to the extremely low wall thickness of the shell material, a largely tensionless nestling of the folded / invaginated shell portions allowed to the wall of the fistula tract. If spatial movements of the body lead to changes in the fistula space, the residual sized / shaped envelope of the occluding or tamponizing body can compensate for them by releasing or receiving envelope walls in the envelope invaginations, thus following movements of the patient while maintaining a uniform force on the exposed surfaces. The folding of the sheath wall ensured by the residual dimensioning also ensures that the occlusion of the fistula tract can take place at very low, perfusion-maintaining filling pressures, since a force-intensive expansion of the balloon body by its production to the working dimension or beyond is not required. As a rule, no more than 20 mbar filling pressure is required for the closure. To fill the closure or tamponade body preferably air is used. The filling pressure acting on the adjacent fistula surfaces can be easily adjusted by a pressure gauge and intermittently determined or controlled by the user.

The device closing off the fistula may have an anchoring structure at the inner end of the fistula tract, which serves as an abutment and, in the case of tensile force acting on the body surface, prevents the device from sliding out of the fistula. The abutment structure can be shaped as a specially preformed, terminal part of the sheath closing the fistula tract, for example as a discoid, plate-like segment. Alternatively, a disc-like, preferably self-elastically erecting element can secure the anchoring of the device according to the invention in the respective cavity.

In the combined application of a closing or tampon-effecting balloon body with a vacuum dressing according to the invention typically the transition of the body cavity is sealed to the fistula passage sealing. On the outside, the fistula tract can then be filled with a secretive-absorbing and -diving sponge structure if necessary. On the body surface, the fistula tract is closed with the help of a tight-closing bandage. Alternatively, the use of such sponge-like structures introduced into the fistula can also be completely dispensed with in the proposed technique.

The closure and tamponade bodies according to the invention preferably consist of a material which allows the shaping of very thin-walled and at the same time mechanically loadable balloon or tubular casings. Polyurethane films offer optimal possibilities here. Film bodies blow molded from pre-extruded tubular fabric can be manufactured in wall thickness ranges of a few micrometers and have almost ideal membrane-like characteristics for the application according to the invention.

The technique according to the invention for supporting the healing process of a fistula connection between the interior of the body and the surface of the body is explained in the following figures by way of example with reference to various embodiments:

shows a body for tamponade of a fistula tract, with a pearl cord-like arrangement of already formed in the production, enlarged and narrowed areas.

shows a possible embodiment of an abutment element on the inner side of a fistula tract, wherein the abutment is a fillable and deployable structure.

shows an alternative embodiment of a not by filling, resiliently erecting abutment element.

shows an embodiment in which both fistula mouths are closed by a fillable element and in the intermediate fistula a vacuum is applied.

shows a corresponding embodiment in which one of the terminal, sealing segments of the closure body in the filled state moves axially directed towards the other.

shows a fistula closure according to the invention schematically in situ.

shows a longitudinal section through a fillable via a feed line, preferably completely or in addition to its required working dimension shaped fistula closure body 1 consisting of a series of spherical and / or discoid or cylindrical sections 2 consists in the manner of a pearl necklace through tubular narrowed areas 3 the envelope wall are separated. The tapered regions preferably have a length which does not exceed one third of the length of the extension. The closure body 1 has an abutment formation at the inner end 4 on, which fixes the end of the closure body in each cavity / hollow organ and secures against dislocation to the outside. The distal end of the abutment segment may be formed by a preferably elastically erecting, plate-like structure 4a , which is connected flat to the distal end of the shell of the fillable portion of the closure body. The plate improves the anchoring of the fistula closure within the cavity to be closed off by the fistula by its areal design. At the outer end, the closure body has a preferably cap-like element 5 on, in the center a closely adapted opening 6 has, through which the inflatable portion of the closure body can be passed for easy length adjustment and adaptation to the anatomy of the patient. In the cap element 5 can be a sponge-like, secretive-absorbing element 7 embedded in the case of an applied vacuum liquid from the fistula or the fistula upstream inflamed skin area can be derived.

The inflatable portion of the closure or tamponade body is preferably filled with air via a filling feed line. This has a closing, the filling holding one-way valve.

The case 8th The preferably bead-like shaped body is preferably constructed throughout from a single element. It basically does not need an internal hose. For facilitated placement of the closure body this can, however, with a guided through the balloon body tubular element 9 be equipped, which allows the implementation of an insertion aid in the placement of the device through the fistula passage therethrough.

Alternatively, the bead-like, fillable extensions but can also be applied directly to a supporting tube separately, can be absorbed through the optional, through appropriate openings, in the spaces between the extensions secretion, and can be derived to the body outside.

In addition to the described chain-like arrangement of the fistula space fills extensions in a simplified design, a consistently cylindrical shaped closure and tamponade is conceivable. However, the ability to force-acting lining of a fistula tract is limited here, in particular in adjoining fistula caverns, since not least axially effective stresses arise during the deployment of the cylinder in cavities and subsequent narrow passages, the uniformly low force on the adjacent fistula walls prevent.

shows a particularly preformed shape of an internal abutment 4 the device. This consists of a fillable, preferably discoid flat shaped balloon-like element, which is made of a thin film as possible with the lowest possible volumetric extensibility and not deformed in zuglastendem train from the outside and thus does not slip into the fistula. The thus formed balloon can optionally by a corresponding supply line 10 from the outside, the actual closure body separately, for example, be filled with a non-compressible liquid. To stabilize the disk shape or to avoid a spherical deformation of the abutment of the refillable abutment balloon with punctual Absteppungen 11 provided that connect the front and back cover of the balloon with each other, for example by spot welding.

shows an abutment element 4 made of solid, preferably elastically righting, plate-shaped material. The disk-like structure can, accordingly deformed, pulled or guided by the fistula when the device of the device and then erect in the respective cavity. For the installation of the device can be a guide wire 12 be used. The element 4 can be on the side facing the fistula with a soft, pressure-damaging layer 4b be equipped by, for example, polyurethane gel.

shows a structure of a closure body according to the invention, in which both fistula mouths by balloon-like extensions 13 and 14 be sealed. The filling of the extensions with an optionally compressible or non-compressible medium takes place through a channel of a two-lumen tube-like connection 15 that connects the two terminal extensions. The hose 15 also has a suction lumen, which has several openings 16 flows into the fistula space. If there is a vacuum in the fistula space, the terminal, preferably conically executed extensions extend 13 and 14 from both sides, following the pressure gradient towards the environment, sealing into the mouths of the fistula canal and thus ensuring the maintenance of the vacuum. The connecting hose 15 In this case, its length can be measured as a residual between the extensions, so it does not have to be optimally short or can be placed without tension in the fistula. Also conceivable is an enlarged portion which can be displaced tightly over the hose 13 in this case, via a separate, from the hose 15 independent supply line for filling has.

indicates a special, on applied embodiment, in which one or both, the terminal extensions 13 and or 14 so on the hose-like connection 15 are applied, that adjusts a directed axial Gegenrollbewegung the two extensions to each other. This is ensured by a special positioning of the balloon ends on the tube, with the balloon ends 15 offset by a certain amount on the tube towards each other or inverted into the shell of the respective extension into it. Thus, an axially resilient rolling movement of the closure device is made possible, which is able to independently adapt to a length of the fistula tract which shortens or lengthens during body movement, even without the installation of a vacuum suction. The tension-free neutral position of the extensions shown in the figure, when the extensions are rolled outward, or away from each other during the deflection of the extensions, into a quasi-resilient tension which actively balances the axial distance between the extensions, with the tendency to return to zero-tension Neutral over.

shows a closure body after schematically in situ. In particular, the sealing effect of the extended segments is tamped 2 represented the closure body. These fill the respectively existing fistula space FR by unfolding their preformed shell portions 8th out. In those parts in which the fistula course limits the expansion of the extensions, the envelope of the shaped closure body transitions into a multiply folded inward involution and, when filled, only occupies the space which is currently offered to it. In the event of changes in the shape of the fistula tract, as is to be expected, for example, during movement of the patient, the filling volume thereby shifts from one segment of the device to the other, whereby altogether a virtually uniform pressure is exerted or exerted on all surfaces of the fistula tract. The closure thus has a dynamism that quickly adapts to the shape of the fistula and compensates for relative movements between the device and the body.

The figure also shows a preferred design of the passage of the fillable, the fistula passage-filling body by the cap member 5 , wherein its central opening 6 as close as possible to the shell quasi clamping and their relative position securing each other, closes. The device can thus be taken by the user, after filling, under moderate train. The length of the unfolding in the fistula passage closure body can be adjusted in this way the lengthening by the passage through the cap member advantageous or adjusted if necessary. The fraction of the closure unfolding outside the body under filling can also be absorbed by a circulating tube (not shown) and thus prevent the free development of extracorporeal portions of the fillable envelope.

When combined with a vacuum technique, the fistula tract can optionally be filled in only partially by the described balloon tamponade. The remainder may be filled, for example, by a sponge-like component which ensures secretion flow under vacuum.

The wall of the closure body described is preferably made of polyurethane durometer Shoe 80 A to 95 A, for example, the grade Elastollan 1180 A to 1195 A BASF, the wall thicknesses in the range of 5 to 30 microns, preferably in the range of 5 to 15 microns should lie.

As an alternative to low bulk extensibility materials, less preferred, a high compliance material such as silicone, latex, or polyisoprene may be used for the tamping portion of the device.

Claims (5)

A device for occluding a fistula-like connection between a body cavity and the body surface, the occluding or tamponizing balloon or tube body consisting of an extremely thin-walled sheath body already molded to its working dimension or beyond, preferably a beaded sequence of extended and tapered ones Has areas and due to the so possible, vorformungsbedingten, an elastic expansion of the sheath wall avoiding, low inflation pressures has a perfusion-compatible, efficient space-filling effect within complex-shaped fistula tracts. A device according to claim 1, wherein, when the fistula tract is only partially occluded between the terminal sealing elements of the device, a negative-pressure space is produced which dissipates wound secretions and is separated from the secretions of the cavity / hollow organ connected to the fistula. Apparatus according to claim 1 and 2, wherein the shell material of the device consists of a polyurethane film of wall thickness of 5 to 30 μ. Apparatus according to claim 1 and 2, wherein the casing material of the device consists of a polyurethane film of wall thickness of 5 to 15 μ. Device according to one of the preceding claims, wherein the casing material consists of polyurethane hardness Shore 80 A to 95 A.

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