DE102018007915A1 - Balloon body for optimized sealing retention of incoming or outgoing medical catheters or occlusive or tamponing devices - Google Patents

Abstract

Catheter balloon for the sealing retention of a substance-supplying and / or dissipating device in the body of a patient or a balloon for the occlusion or tamponade of a natural or artificial body opening, the balloon body consisting of separately formed segments of different wall thickness and / or material hardness and / or polymer Types, and the individual segments are each adapted in terms of material thickness and hardness of the respective mechanical function to be fulfilled, so for example, the relatively larger in diameter, retentive balloon portion of relatively thick-walled, moderately extensible, for the anchorage of the device advantageous material, and in diameter relatively smaller, sealing balloon portion of relatively thin-walled, volumendehnbaren, adapted for the tissue-preserving seal material, and wherein the respective functionally optimized segments by preferably overlapping surface e, circular contact surfaces, for example, by a mounted in the intermediate gap adhesive or solvent sealingly connected.

Description

In many medical catheter applications, the general problem of as efficiently sealing and while possible biocompatible supply and / or discharge of substances through natural or artificial openings in the body or in organs or other cavities or spaces in the body.

In particular, when the patient is physically active, that is, when there are versatile relative movements between the sealing device and the body, leaks in the area of entry or exit of the catheter or device are common and can adversely affect the efficiency and safety of the product application. Prolonged relative movement between an inlet and / or discharge device and the tissue and structures adjacent to the device in the area to be sealed can lead to irritating misperceptions as far as pronounced, complex lesions to be treated. Correspondingly caused lesions occur in particular in the area of the passageway through the body or organ wall.

Catheter devices designed for long-term retention in the body are often equipped with a retinal balloon component anchoring the device in the body. The retiring function is hereby produced by a balloon body, which sits distally on the shaft of the device and fixes the device in the body or organ cavity which adjoins the passageway inwardly. These primary anchoring, fixing balloon components should be mechanically stable or dimensionally stable, and, in particular with a tensile force acting axially on the device, keep a certain shape which is advantageous for the retention, with the least possible deformation.

Catheter-like devices are known in which a further, trans-luminally sealing or space-filling balloon element or else a balloon compartment emerging from the retinal balloon adjoins the retaining balloon element, which passes completely or partially through the passageway through the body or organ wall or fills. Such retention balloons with a trans-luminal balloon segment are for example made DE 2014 017 873 or PCT / EP / 2012/003535 known. In the described embodiments, the balloon portion passing through or filling the channel is directly apparent as a proximal extension from the retaining balloon portion. The proximal balloon portion has a primary sealing function here. The free communication of the distal, anchoring portion with the proximal, sealing portion of the balloon, a dynamic, the respective functional state of the body or organ adapted sealing function can be achieved. In this case, a respective force acting in the interior space of the body cavity or the organ is absorbed by the distal balloon portion and used simultaneously, time-synchronously in the trans-luminal part of the balloon to seal the passageway.

The embodiments of such balloon bodies described in the aforementioned applications are preferably produced by blow molding from pre-extruded tubing. In this case, the Rohschlauch auszuformende is usually pre-stretched and thinned by axial stretching. During the subsequent subsequent radial shaping of the hose thus pre-stretched into the cavity, the wall thickness is further reduced. Due to the rising from the raw tube increasing dilution of the balloon body in the most criticized by the tube axis wall portions are, especially in such a blow molding of polyurethane-based materials, in the center of the disputed balloon shell shares the rest of the balloon shell relatively thinnest wall thicknesses ,

However, with the described form of producing a balloon body by blow molding, a functionally fundamentally disadvantageous design of the wall thicknesses arises for many applications. Unlike what is required for many applications, in many cases, the balloon retentive portion has reduced wall thickness due to the large diameter required for retention, relative to the trans-luminal sealing portion of the balloon. In the sense of a primarily retiring function of the distal balloon portion, however, this should preferably be thick-walled, while the primary sealing balloon portion of the device should preferably be produced in the most thin-walled form possible. As a result of the manufacturing process, reciprocal wall thicknesses arise for the respective functional requirement of the balloon portion, which on the one hand reduce the mechanical load capacity in the case of, for example, tensile load, and on the other hand disadvantageously reduce the sealing efficiency in the area of the passage to be sealed by a body or organ wall.

The present invention describes a structural principle which ensures the mechanical, in particular anchoring (retentive) stability of the distal balloon portion by a suitably large wall thickness and at the same time adapted the tissue gently sealing function of the proximal, trans- or intra-luminal portion by one of the respective sealing task Optimized reduction of the wall thickness of the balloon envelope.

For this purpose, the invention proposes a separately blown, relatively thick-walled, distal balloon, at the proximal end of which a likewise separately shaped, relative to the distal balloon thin-walled, proximal balloon connects. Both balloons are then connected in the transition region, for example by an adhesive bond or by a solvent-based welding, tight closing together.

In this way, the free communication of the retiring with the sealing balloon portion and thus its ability to dynamically absorb a force within a body space or the use of this force to seal the access lumen to the respective body space.

The invention is preferably based on the use of polyurethane as the base material for balloon production. The wall thicknesses for the proximal sealing or tampon balloon portion are in the embodiment in PUR preferably in the range of 5 to 30 .mu.m, more preferably 10 to 15 microns. The wall thickness of the distal, primarily retinating balloon portion can be adapted to the respective functional requirement. It is within the scope of the invention preferably at 15 to 50 microns, preferably 20 to 30 microns.

Alternatively, the distal and proximal balloon portions may be fabricated from material hardnesses of the same type of material adapted to the particular function as well as from different types of materials.

The invention also relates to devices whose primary purpose is the sealing closure of a natural or artificial body orifice. In the case of the corresponding devices, the sealing balloon body can be seated on a bearing shaft element or, alternatively, also be inverted or inverted in itself, whereby a more or less rigid shaft element can be completely dispensed with during the construction of the intracorporeal portion of the device.

The structural principle of the invention is described in the following figures with reference to concrete embodiments.

shows a combined retention and sealing balloon with an ankernd acting distal balloon portion and a proximal, by joining subsequent, tapered relative to the distal balloon portion proximal balloon body.

shows a dumbbell-shaped balloon with a central, separately manufactured or molded balloon segment.

indicates a corresponding balloon in which the proximal subsequent balloon has a terminal spherical extension.

shows a cross-section through a trans-luminally placed balloon segment, which has a relative to the diameter of the access path or the body opening residual diameter.

represents an embodiment of a functionally optimized balloon body according to the invention 1 which is essentially similar to one already in DE 2014 017 873 described construction type, in which a distal, spherical or, for example, also discoid extended retention segment 2 towards the proximal end of the balloon, a cylindrical sealing segment 3 followed. The connection of the two separately molded or produced balloon body takes place through a joining surface FF, in which the two balloon ends 4 and 5 the balloon segments to be connected are positioned in an overlapping manner. In the intermediate gap then, for example, a connecting, UV-light-curing adhesively acting adhesive or a solvent is introduced.

The in DE 2014 017 873 described bladder catheter balloon can exemplify the inventive principle of sequential joining of blow molded balloon segments of different wall thickness and the associated functional optimization of the respective segment properties. For example, the combined anchoring and sealing function of the balloon body may be optimized such that the distal intra-vesical balloon portion has a wall thickness of 15 to 25 μm and the sealing proximal urethral portion of the balloon preferably measures 5 to 10 μm.

• Distaler Ballon bzw. Ballonanteil, bevorzugte Durometer nach Shore von 90A-95A; Wandungsstärke im Bereich des größten sphärischen Ballondurchmessers von bevorzugt 15 bis 25 µm;
• Proximaler Ballon bzw. Ballonanteil, bevorzugt Durometer nach Shore von 80A-85A, mit einer Wandungsstärke im Bereich des proximalen Ballonzylinders von 5 bis 10 µm;
• zeigt einen erfindungsgemäß optimierten Ballon, wie er in PCT/EP/2012/003535 beschrieben wird. Der trans-anal platzierte Ballonkörper 1 weist eine hantelförmige Grundfigur auf. Auch hier ermöglicht die Erfindung die Beibehaltung der für die spezifische Anwendung vorteilhaften Ballongeometrie, bei einer entsprechenden, funktionell vorteilhaften Umkehr der Wandungsstärken. Die Ballonfigur verfügt über eine proximal endständige Erweiterung 6, die sich dem mittigen, verjüngten, wandstärkenreduzierten Segment 7 anschließt. Vorteilhaft für die Retention ist wiederum die erfindungsgemäß erreichbare höhere Wandungsstärke in den jeweils endständigen Ballonanteilen, wobei dich Dichtungsleistung bzw. die Gewebeverträglichkeit durch die Wandstärkenreduktion im mittigen Teil optimiert wird. In dieser besonderen Ausführung kommen für die Montage des Ballonkörpers drei vorzugsweise separat geblasformte Ballonkomponenten zum Einsatz.

In addition to the option of segment-based adjustment of the wall thickness, a function-optimizing adaptation of the material hardness can take place alternatively or simultaneously. So can the in DE 2014 017 873 described balloon, for example, in the distal portion are preferably made of a harder durometer with lower volumendehnbarkeit and elastic deformability, while the proximal part is preferably volumendehnbar, that can be made of a material of low hardness. In the DE 2014 017 873 described function as a bladder catheter with dynamic, trans- or intra-urethral seal can be achieved according to the invention, for example by the following specific choice of material:

• Distal balloon, preferred Shore durometer of 90A-95A; Wall thickness in the range of the largest spherical balloon diameter of preferably 15 to 25 microns;
• Proximal balloon or balloon portion, preferably durometer to Shore of 80A-85A, with a wall thickness in the region of the proximal balloon cylinder of 5 to 10 μm;
• shows an inventively optimized balloon, as in PCT / EP / 2012/003535 is described. The trans-anal placed balloon body 1 has a dumbbell-shaped basic figure. Here too, the invention makes it possible to maintain the balloon geometry which is advantageous for the specific application, with a corresponding, functionally advantageous reversal of the wall thicknesses. The balloon figure has a proximal terminal extension 6 , the central, rejuvenated, wall thickness-reduced segment 7 followed. Advantageous for the retention in turn is achievable according to the invention higher wall thickness in the respective terminal balloon proportions, where you sealing performance or tissue compatibility is optimized by the wall thickness reduction in the central part. In this particular embodiment, three preferably separately blow molded balloon components are used for the assembly of the balloon body.

shows the same basic figure as in However, with the tapered central and the relatively enlarged, proximal terminal balloon portion of a single, consistently shaped balloon element 3a consist.

shows a cross-section Q through the trans-luminal part of the devices and , The diameter of the segment is thereby preferably formed to a residual excess, which exceeds the diameter of the respective body opening and in the filled state to form radially to the center or to the catheter shaft 8th towards aligned folds or invaginations 9 the balloon cover 10 invaginated. Residual dimensioning and resulting envelope folding avoids the need for any forceful expansion of the balloon envelope. The particularly low wall thickness of the shell wall in this segment allows despite the multiple folding of the balloon envelope an optimal seal, for example, against escaping urine or intestinal contents. The feeding channel 11 In this case, the organ or cavity can be irregularly shaped in cross-section or can also have prominent structures reaching far into the lumen of the channel. The formation of residual invaginations guarantees homogeneous, as low a force as possible on the exposed tissue.

QUOTES INCLUDE IN THE DESCRIPTION

This list of the documents listed by the applicant has been generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Cited patent literature

• DE 2014017873 [0004, 0018, 0019, 0020]
• EP 2012/003535 PCT [0004, 0020]

Claims (10)

A device for sealing retention of a substance-supplying and / or dissipating device or a balloon for the occlusion or tamponade of a natural or artificial body opening, wherein the balloon body anchoring the device in the body of a patient has a relatively larger, retentive and diameter-relative diameter smaller, sealing segment, characterized in that the retiring balloon portion has a wall thickness which is greater relative to the wall thickness of the sealing balloon portion, and the two balloon portions are each made separately and are connected by a tight-fitting connection in the joining region of the shares. Device after Claim 1 , wherein the balloon body consists of separately formed segments of different wall thickness and / or material hardness, and the individual segments are adapted in terms of material thickness and material hardness of the respective mechanical function to be fulfilled. Device after Claim 1 , wherein the balloon body consists of separately formed segments of different wall thickness and / or material hardness and / or polymer grade, and the individual segments are adjusted in terms of material thickness and material hardness of the respective mechanical function to be fulfilled. Device according to the preceding claims, wherein the retaining balloon portion consists of high-durometer material adapted to anchor the device in the body relative to the trans-luminal sealing portion of thick-walled, moderately extensible material. A device according to the preceding claims, wherein the sealing balloon portion consists of a relatively retentive portion of thin-walled, low-durometer elastically extensible material adapted for the tissue-protecting seal. A device according to the preceding claims, wherein the trans-luminal sealing balloon portion may comprise a terminal extended compartment. Device according to the preceding claims, wherein a central, tapered, thin-walled and preferably volumendehnbar executed, trans-luminal sealing balloon portion may be inserted between two retentive, spherically enlarged, moderately deformable balloon portions. Device according to the preceding claims, wherein the respective balloon bodies to be joined are produced at least in part by blow molding. Device according to the preceding claims, wherein at least one of the balloon portions to be joined is produced by blow molding from previously extruded polyurethane tubing. A device according to the preceding claims, wherein the shaped diameter of the trans-luminal sealing balloon exceeds the diameter of the body channel to be sealed, and which folds in the region of the channel when filled in situ.

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