DE20320631U1 - Device used in medicine for plugging hollow spaces comprises a flexible double-walled inflatable tube segment - Google Patents

Abstract

Device comprising a flexible double-walled inflatable tube segment (2), is new.

Description

The Invention is concerned with an apparatus for use in Healing processes, according to the top handle of claim 1.

In Devices are known in medical technology for tamponade of cavities serve. The devices consist of inflatable elastic Hollow bodies. There are different sizes of these hollow bodies known to seal ostia of different sizes. Be used also devices in their outer contour are designed so that they can fully fill a cavity when inflated.

at the tamponade, especially of rooms in the area of biological Tissue, there is a problem that the tamponade may not completely adhere the contour of the cavity is adapted and undesirably exerts pressure on adjacent mucous membranes. This Problem is exacerbated by that the tampon bladder is not designed with residual volume and high restoring forces consist of the wall material used. If there is a tamponade of nasal cavities about that furthermore the problem that the nasal cavity is a strictly centrally controlled locally erectile tissue system which cannot be influenced, which periodically shows circadian pressure fluctuations, which increase add the internal pressure of a non-residual volume tampon, which increases the danger will that by tamponade the vascular perfusion of the adjacent Tissue is prevented. In view of the very different proportions with sinuses and the big one Variety of inter-individual spatial shapes and volumes in the area of anatomical spaces, a variety of anatomically preformed devices are required. This is very expensive.

Next the devices for tamponade from Ostien respectively cavities are used in medical technology catheters made of an elastic Catheter shaft and a refillable balloon element attached to it. The catheter body has one backfill the over an opening opens into the inside of the balloon in the catheter wall. The balloon element itself, primarily for secure mechanical anchoring of the catheter. Moreover he often has one sealing function and prevents, for example, urine from the Urinary bladder flows past the catheter through the urethra. The one attached to the catheter Balloon strives when filling to take a spherical shape with a fluid. As a result, the largest cross section the cross section of the ostium of the cavity and prevents so that the retraction by nestling on the edge of the opening of the Cavity. The spherical shape of the balloon can hold and seal insufficiently fulfilled because it tends to have a spindle-like shape under tensile load to accept and slip into the ostium, causing the fixation and the relatively small sealing contact surface between the balloon wall and Edge of the cavity ostium is lost. This is a problem which is of particular importance in the field of biological tissue because the Body cavity ostia usually do not have a fixed width. For this reason, too, will be more or less large retaining washers made of rigid material attached to the catheter shaft due to their voluminous Construction in small ostia that is in the range of millimeters lying, are not usable. In addition, the spherical balloon on the continuous support body, the is called the catheter body, which is particularly important in confined spaces disturbing can work.

State of technology

Through the EP 0 624 349 B1 A device for tamponade and for keeping open bone-restricted body cavities and passages after surgical manipulation is known, in which the outer contour of the balloon in the fluid-filled state is adapted to the inner contour of the body cavity. In this device, the balloon is designed as an anatomically idealized catheter and is wedge-shaped adapted to the human frontal or ethmoid sinus. The main disadvantage of this device is that a large number of sizes is required with a large variation in the shape of these spaces.

presentation the invention

The The invention is based on the object of a device for use to create healing processes that avoid the disadvantages mentioned above and is versatile. The device should be as possible both when tamping and when attaching catheters be usable. Finally if possible economical can be produced and in terms of course given sizes of cavities can be used in both areas.

The solution the object is achieved according to the invention by the features of claim 1. The subclaims 2 to 23 give advantageous developments of what is included in claim 1 Inventive idea again.

The design of the device as a flexible double-walled inflatable hose segment gives the possibility of a wide range of applications. In addition, the device is very simple produced.

In the simplest embodiment the tubing segment through an inner wall and an outer wall formed which comprise a cavity, at least the outer wall thin-walled and is elastically stretchable. When introducing a fluid, that is, one liquid or a gas in the hose segment, the outer wall of the hose segment unfolded and lies against the walls of the Ostiums, or on the walls one to be filled Cavity. The unfolding and the elastic stretchability of the outer wall serves the complete Adaptation of the outer wall to the circumstances.

Of The advantage is if the tube segment is made of a transparent material consists. Polyurethane is a particularly suitable material here, or a polyurethane-polyvinyl fluoride mixture or a comparable Material based on polyurethane or a polymer with comparable expansion and processing characteristics in question. When using this material, the tubing segment particularly thin-walled getting produced. The desired wall thickness is in the micrometer range preferably 5 to 15 microns. Besides, can a probe from the outside in introduced the hose segment and the cavity can be viewed from the inside. Such a hose segment can be used as a tamponade of cavities or ostia, as well be used for the reversible sealing fixation of catheters; in which it is arranged at the end of a catheter.

The Due to its properties, the device is particularly good at Tamponade of natural or artificial suitable Ostien suitable. Catheters can also be found in hollow organs such as the bladder, The stomach or intestines are well fixed. The result of the new fixation also a better seal against the opening of the cavity than that with a spherical Balloon possible would be there a sealing contact not with a relatively small area of the Cavity wall takes place immediately adjacent to the ostium of the cavity, but with a much larger contact area that caused by the proximal torus bulge given by the tube segment comes. When filling of the inflatable tube segment with the fluid, an elongated segment is created Torus with particularly favorable sealing properties.

The Manufacture of the hose segment is particularly cheap Way through an invagination of a single-walled hose section. A tube section of a predetermined length, for example of 10 cm is put inside each other, so that both ends of the hose section roughly one above the other lie. The ends can then to a terminating element in the form of a pipe nipple or also be attached to a suitable location on a catheter. In from the walls of the inner tube segment formed in this way a channel for the derivation of a fluid is used. Becomes a Fluid introduced into the interior of the hose segment, so folds and stretches the outer wall of the hose segment and can be used at the appropriate point serve to tamp or fix a catheter.

Around achieve the particularly good mode of operation of the subject matter of the invention to be able the tubing segment becomes invagination prior to its formation preformed as a single-walled hose. This preforming is preferably carried out in this way. This preforming is preferably carried out in such a way that the the outer wall of the tube segment forming tube portion after the invagination inflated in the plane of rotation of the tube segment Torus results. The preforming can be different strengths, that is, after preforming and invagination the outer wall of the hose segment folded more or less on its inner wall is applied. It is also possible through preforming at least the one at the outer end of the tube section adjacent after inflation Training the end wall, to achieve an improved sealing effect for special cases.

All in general, when preforming the single-walled hose so that the part of the hose; which after the invagination the inner wall of the tube segment forms a smaller cross section and a larger one. Has wall thickness than the portion of the tube forming the outer wall after the invasion.

All in general, it is also provided that the device with respect to the Volume of a body cavity to be tamponed by her with residual volume is, that is, that the tube segment has a larger volume when unfolded has than the body cavity to be tampon.

The Wall thickness, at least the outer wall of the hose segment, is in the range of a few micrometers, so that a good development of the outer wall is possible. The one when unfolding in a cavity of excess wall material to be tamped by the device resulting wrinkles are in the dimension of a capillary. hereby become liquids due to adhesive forces in it recorded.

The channel opening into the interior of the hose segment is connected via a flexible ver connecting hose connected to a valve located outside the hose segment. The valve can be designed as a valve lip. However, it is also possible to provide the channel with a circular sleeve made of flexible material, which prevents the fluid from flowing back out of the interior of the hose segment.

at In some areas of application it may be advantageous if the outer wall of the hose segment made of a polar, slightly water-permeable material is formed. This material can be a smipermeable membrane, for example his.

The new design of the device as a hose segment also leaves to that to measure the transmural pressure in inflation, in A pressure sensor is attached to the interior of the hose segment. This causes excessive pressures in the Avoided inflation of the device.

In order to the fluid is not inadvertently from the interior of the hose segment. escapes, is in. A valve is attached at a suitable point in the duct. Here are different options in terms of the selected one Place in the channel as well as the design of the valve yourself possible.

According to one Variant can be pushed onto the hose segment with a clamp to the partial or complete completion of the channel one lengthways has slidable cuff. This cuff can be used simultaneously. by Also move the size of the hose segment pretend yourself.

Finally, can a collar-shaped abutment is attached to the pipe nipple or the catheter shaft be, which a pinching and fixing a cavity wall on Hose segment enables.

The Hose segment is due to the ideal Torusgeomentrie, the in the case of inflation, it strives for the desired fixing and sealing requirements just. The tube segment can be in such a deflated state stretched out lengthways lie folded up that it is through very narrow openings introduced can be. The hose segment can be used as a positioning aid if required with a management staff or be equipped with a guide tube. The outstretched double hose body, however, shows through itself the close togetherness of four wall layers in the deflated A certain stiffness, which alone makes it possible him for to position most applications. This self-supporting effect can be increased by making the invaginated tube wall part thicker is than the rest Part of the hose segment.

at Inflation of the proximal or distal of the combined tube ends elongated Hose segment creates a relative movement of the hose wall ends and the hose body. If inflation continues, there will be a shift in the tube wall material between the axis of rotation near and the axis of rotation away Percentage of tubing that starts from the moment when the two touch the hose parts facing the axis of rotation, and is maintained until the combined hose wall ends have maximally approximated the center of rotation of the unfolded torus and thus the most energetically favorable Geometry for that inflated tube segment is ingested. Are the two of them summarized ends of the hose outside the hollow body wall fixed, the hose segment nestles with its ring-shaped bead against the wall of the cavity and presses the wall against the collar-shaped. abutment on. The tube segment is held in position for as long as the internal pressure is maintained.

is the tube segment is stretched proximally in the deflated state, this results in a movement of the hose segment after inflation distally, which is suitable the tube segment into a cavity to unfold. The hose segment is therefore also suitable for fabrics to displace from a cavity.

The Hose segment is suitable due to its thin-walled and residual volume Design that without end-to-end Carrier body gets along especially for tamponade of structurally complicated rooms or of spaces with a pressure sensitive mucosa such as the nasal cavity and its Sinuses. It is suitable for general applications in which a direct transmission of the Internal pressure without addition of retraction force of the wall material of the tube segment on the body cavity wall is necessary in this way by means of an external connection to the channel Manometer the pressure directly acting on the surrounding tissue to be able to measure with the aim of tamponade the vascular perfusion pressure of the adjacent Do not exceed the fabric. The torus shape of the hose segment also offers the possibility a pressure sensor without being at the boundary layer with the surrounding Tissue is disruptive, in the interior between the hose components close to the axis of rotation of the double hose body place. The pressure measured here corresponds to residual volume of the hose segment the pressure of the parts of the hose which are remote from the axis transferred to the surrounding tissue becomes.

If the tube segment is equipped with a thin wall of polyurethane through which water "dissolves" in small quantities, the tube segment can also be used for the drainage of cavities or for the protracted application of polar active pharmaceutical ingredients, such as N ₂ O, across the wall from the inside out.

is the hose segment is equipped with an internal valve mechanism, so the tube segment can be separated from the fluid supply after inflation become. This makes it possible the tube segment in the inflated state, e.g. in use for Tamponade of the nasal cavity, of distracting Disconnect leads and the proximal end of the closure, to fix externally on the body surface. The fully or partially re-rated, double slotted and in retraction over the clamping element spread clamp serve if he executed in the way is that he is not divided along the entire length. is present, but distally a closed, the still folded tube wall material comprehensive tube portion and proximal in any Position by a cuff which slides against the one below horizontal, undeveloped, portion of the hose can be found can.

For the special Case of nasal tamponade after nasal septum surgery can be the tubing segment be used in such a way that it is in its central clear opening a clip is fitted, which unfolds the one-sided turning laps Double hose body gathers and so a flat contact surface in the sense of a rail for the nasal septum possible makes, the splinting through the tamponade of the rest of the room the nasal cavity by means of the now pillow-like, opposite part of the hose segment is entertained. The leg of the nasal septum of the clamp-shaped Rail can also do this as a carrier for therapeutic agents serve and to maintain the gathering of the hose wall material be fixed to the end element.

Summary the drawing

Based several embodiments the invention will become more apparent below explained.

It shows:

1 schematically a preformed hose section,

2 the preformed hose section 1 , trained by invagination to the tube segment,

3 an inflated tube segment in longitudinal section,

4 2 shows a longitudinal section in a schematic representation through another embodiment of a tube segment on a catheter,

5 a tube segment in longitudinal section with an inserted clip and

6 a tube segment with a clamp closure pushed on.

Execution of the invention

In the 1 is a hose section 1 shown which for the manufacture of a hose segment 2 is preformed. The hose portion 3 which is the later inner wall 4 of the hose segment 2 , forms, is, as far as it concerns its wall thickness and its inner or outer diameter, unchanged. On the other hand is the hose portion 5 which the later outer wall 6 of the hose segment 2 forms, expanded considerably, whereby the wall thickness was greatly reduced. That too on this hose parts 5 subsequent hose end 7 is partially expanded. This preforming is carried out in heatable molding devices. As material for the hose section 1 for example hose segment 2 , a transparent polyurethane is used.

To form the hose segment 2 becomes the relatively stable hose part 3 into the interior of the hose portion 5 pressed in and the hose end 7 passed on, so that in the 2 shown form arises.

In the 2 is the unfolded shape of a tube segment 2 , drawn. For this purpose there is a fluid in the interior 8th which from the inner wall 4 and the outer wall 6 is limited. When the interior is empty, the outer wall lies 6 when folded on the inner wall 4 on.

The 3 shows a practical embodiment of the hose segment 2 how it can be used for tamponing. The two ends 7 and 9 of the hose segment 2 , are from the final element 10 , recorded in a fluid-tight manner. The final element 10 is designed in the form of a pipe nipple. The one in the middle of the pipe nipple 10 existing opening 11 can through a stopper 12 be closed. But it is also possible in the opening 11 to introduce a catheterization. The interior 8th of the hose segment 2 , is on the channel 13 connected, which is intended for the extraction or discharge of a fluid: the hose segment 2 is inflated and greatly enlarged shown. In the canal 13 is a valve 14 used that an unwanted drain of the fluid from the interior 8th prevented. In the example is the valve 14 formed by a valve lip known per se.

In the 4 An embodiment is shown in which the hose segment 2 at the end of a catheter 15 is appropriate. The ends 7 . 9 of the hose segment 2 , are with the catheter tube 15 connected. The channel 13 leads into the interior 8th of the hose segment 2 , The example shows the attachment of the hose segment 2 in an unspecified cavity. In this case, the catheter shaft 15 an abutment 16 be placed in a collar-like manner, for example, the skin 17 at the opening of the cavity between the abutments 16 and the outer wall 6 of the hose segment 2 can be tightly clamped.

The 5 shows the use of the hose segment 2 with simultaneous use of a bracket 18 , The clip 18 consists of rigid material and is with one leg 19 in the free space 20 of the hose portion 3 inserted. Through the bracket 18 can the hose segment 2 be provided with a stiff portion on a desired side.

The 6 shows an application form of the hose segment 2 , on the hose segment 2 a clamp 21 is postponed. By moving the clamp lock 21 along the tube segment 2 can be the size of the inflated portion of the tube segment 2 be determined. The further the clasp 21 seen on the drawing is pushed to the left, the larger the released portion of the hose segment 2 , To lock the clamp 21 is the same with a cuff that can also be moved lengthways 22 Mistake. The clamp lock 21 is divided over almost its entire length and its wall thickness is selected so that the sleeve can be moved along the clamp fastener 21 to a stronger or weaker end of the hose segment 2 or the channel 13 leads.

As the examples show, the new hose segment can be used in a variety of ways and also provides improved access for visual probes, pressure gauges and the like into the interior of the cavity. The hose segment even allows liquid or solid parts to be removed from the cavity without the use of special instruments, simply by pulling on the inner wall 4 and at the same time supporting the outer wall 6 due to the inner bulge of the hose segment 2 a kind of lip-shaped closure is formed.

Claims (23)

Device for the use of medicinal preparations, characterized in that it consists of a flexible double-walled infectable tube segment ( 2 ) consists. Device according to claim 1, characterized in that at least the outer wall ( 6 ) is thin-walled and elastically stretchable. Device according to one of claims 1 or 2, characterized in that at least the outer wall ( 6 ) of the tubular body segment ( 2 ), has a wall thickness of a few micrometers. Device according to one of claims 1 to 3, characterized in that the hose segment ( 2 ) consists of a transparent material. Device according to one of claims 1 to 4, characterized in that the hose segment ( 2 ), consists of a polyurethane, a polyurethane-polyvinyl chloride mixture, or a comparable material based on polyurethane or a polymer with comparable elongation and processing characteristics. Device according to one of claims 1 to 5, characterized in that the hose segment ( 2 ) is used as a tamponade for body cavities. Device according to one of the claims 1 to 5 , characterized in that the hose segment ( 2 ) for the reversible sealing fixation of a catheter at the end of a catheter shaft ( 15 ) is arranged. Device according to one of claims 1 to 7, characterized in that the hose segment ( 2 ) by invading a single-walled hose section ( 1 ) is formed. Device according to claim 8th , characterized in that the ends ( 7 . 9 ) of the hose section ( 1 ) to a final element ( 10 ) are connected. Apparatus according to claim 9, characterized in that the end element ( 10 ) has the shape of a pipe nipple. Device according to claim 8, characterized in that at least one end ( 9 ) of the hose section ( 1 ) on a catheter shaft ( 15 ) is attached. Device according to one of claims 1 to 11, characterized in that in the of the Walls ( 4 . 6 ) of the hose segment ( 2 ) formed interior ( 8th ) a channel ( 13 ) for the supply or discharge of a fluid. Device according to one of claims 1 to 12, characterized in that the hose section ( 1 ) or a part of it before training to become a tube segment ( 2 ) is pre-shaped like a single-walled tube by invagination. Device according to claim 13, characterized in that the preforming reinforces the invagination perpendicular to the plane of rotation of the tube segment ( 2 ) resulting bead is generated. Device according to claim 13, characterized in that the hose section ( 1 ) is preformed such that the hose portion ( 3 ) which, after the invagination, the inner wall ( 4 ) of the hose segment ( 2 ) is smaller in cross-section and has a greater wall thickness than that of the outer wall ( 6 ) forming hose rope ( 5 ). Device according to one of claims 1 to 15, characterized in that the hose portion ( 3 ) is made with a uniform wall thickness and a uniform inner diameter. Device according to one of claims 1 to 16, characterized in that the hose segment ( 2 ) has a residual volume. Device according to one of claims 1 to 17, characterized in that the channel ( 13 ) via a flexible connecting hose with an outside of the hose segment ( 2 ) located valve ( 14 ) connected is. Device according to claim 18 , characterized in that the valve ( 14 ) is designed as a valve lip. Device according to one of claims 1 to 18, characterized in that, as a valve ( 14 ) a circular sleeve made of flexible material, which is between the hose ends ( 7 . 9 ) is attached, is provided. Device according to one of claims 1 to 20, characterized in that on the hose segment ( 2 ) a clamp ( 21 ) is pushed on, which is a longitudinally movable sleeve ( 22 ) Has. Device according to one of claims 1 to 20, characterized in that on the pipe nipple ( 10 ) or catheterization ( 15 ) a collar-shaped abutment ( 16 ) is attached. Device according to one of claims 1 to 22, characterized in that; that in the interior ( 20 ) a pressure sensor is included.