The invention addresses a device and a method for draining urine from the bladder of a patient.
Urinary catheters for continuous, closed draining of urine from the bladder of a patient in in a collection vessel are established in medical practice and various embodiments thereof are known. Indwelling urinary catheters are normally introduced into the urinary bladder by transurethral catheterization. In contrast to catheterization of the bladder with disposable catheters, during which a catheter-tike tube is advanced intermittently through the urethra into the interior of the bladder, i.e., only for the actual duration of emptying the bladder, catheters for permanent transurethral draining of urine are equipped at their distal end typically with a balloon-like anchor element (retention balloon), the primary function of which is securing the position of the catheter end that receives the urine within the bladder.
In the case of the overwhelming majority of known design types of so-called indwelling catheters, these retention balloons are made of elastically expandable tube materials, which are nestled snuggly against the shaft body of the catheter and are seated as much as possible without any preformation as smooth, fold-free, cylindrically formed tube bodies (sleeves). Because they are filled with a non-compressible fluid medium, an approximately spherically formed balloon body expands from the cylindrical tube body when there is a correspondingly high filling pressure. What is disadvantageous in the case of these types of anchor balloons that are expanded by high filling pressure is above all the hard consistency of the balloon resulting from the expansion of the sheath. In the case of a longer indwelling duration, erosive changes and to some extend also pronounced ulcerations of the bladder's mucous membranes occur in the contact area of these types of rigid, “hard” balloons on the base of the bladder, in particular in the region of the so-called bladder trigonum. In the case of the sustained presence of bacteria in the urine, chronic infections of the urinary tract can develop based of these types of tissue defects. The current research in the field of urinary tract infections (UTIs) values an epithelium of the bladder and also of the urethra that is as intact as possible and as non-eroded as possible as an essential prerequisite for preventing chronic urinary tract infections.
In addition to conventional, sleeve-based catheters, retention elements based on preformed balloon components are also known from the literature. These kinds of components are presented for example in EP1448259 or PCT/IB2015/002282. The retention in this case is guaranteed by balloon components that are formed completely or even partially in terms of the working dimensions required for the respective function already during manufacture of the catheter. The balloon elements are made of membranous thin-walled, but high-strength materials, which in an unfilled state are minimally applied to the catheter shaft in such a way that the formed balloon component can be advanced comfortably and without irritation through the urethra during insertion of the catheter.
More recent literature on the subject of UTIs furthermore makes reference in many cases to the traumatizing effect of conventional catheter tips on the dome of the bladder that is exposed to the tip. The normally relatively rigid tip, which extends beyond the retention balloon and finger-like into the bladder lumen, burrows into the tissue of the dome of the bladder with sustained exposure and thus leads regularly to other lesions that are directly associated with catheters.
Embodiments of catheter tips in a variety of designs are known that prevent lesions of the urethral wall, in particular during insertion or advancement of the catheter through the urethra, and are meant to facilitate catheter placement as a whole. Several design types moreover attempt to guard against injuries to the dome of the bladder. For example, dual balloon arrangements are described, such as is the case with the Duette type from Poiesis Medical Ltd., wherein the tip of the catheter is accommodated in a protective manner in a spherical, balloon-like element, while another balloon element rests in a retaining manner on the base of the bladder. In the case of Duette, the urine is drained through an opening of the catheter shaft between the two balloons.
Another effect that directly traumatizes the urinary tract is caused by the structure of the urine-draining shaft segment of the conventional catheter. The shaft attaches proximally at the balloon being retained in the bladder and drains the urine transurethrally. The shaft element is typically made of a tube material that is designed to be relatively thick-walled and is based on silicone, or is made of materials based on natural rubber. The thick-walled design of the shaft wall ensures, on the one hand, that the urine-draining lumen does not get occluded from kinking in the case of axial bending or twisting of the shaft. On the other hand, the thick-walled shaft structure ensures that the urine-draining lumen of the shaft does not collapse from the high pressures acting in the balloon during the elastic expansion of the balloon sleeve into a spherical balloon. In particular, the shaft wall thicknesses required by the balloon filling pressure restrict the structurally achievable diameter of the urine-draining lumen. Draining through small diameters tends to lead to premature encrustation or successively to occlusion from the ongoing deposition of urine components. Therefore, in order to achieve the longest possible application periods, the largest possible inner diameters are striven for, which require, in turn, large shaft outer diameters. The approximation of the shaft outer diameter to the diameter of the urethra that is consequently required in the case of a conventional catheter design leads, in conjunction with the rigidity of the shaft materials, frequently to pronounced erosions of the epithelial lining of the urethra, whereby, in the case of a long indwelling duration, this regularly results in inflammatory processes, and subsequently in cicatricial strictures of the urethra.
Another factor that supports the development of chronic urinary tract infections is the accumulation of so-called residual urine in the bladder. Residual urine empties out of the bladder only in delayed manner and therefore is apt to accumulate larger amounts of bacteria. Various embodiments are known which prevent the pooling of urine, predominantly by draining the urine via openings of the catheter shaft, which are positioned especially close to the base of the bladder.
In order to prevent injuries during the placement of the catheter, gel-like substances are being used with good success. On the one hand, they reduce the friction between the catheter shaft surface and the epithelium of the urethra. Beyond this lubricating effect, gels make a transient straightening or filling the urethra lumen possible. In a more or less circularly straightened state of the urethral lumen, the catheter tip and the catheter shaft can thus be inserted in an optimum manner with low friction through the lumen of the urethra.
Urinary catheters are frequently packed in a set containing all paraphernalia required for the catheter placement. The ready-to-use sets are generally speaking unnecessarily extensive, and in many cases no longer self-explanatory in terms of handling and hinder the application of the product.
The object of the invention is to avoid the disadvantages of the prior art described in the foregoing.
To address this problem the invention provides, as a part of a device for draining urine from the bladder of a patient, a functional unit comprising
As a part of the present patent application, the terms “indwelling part”, “indwelling unit”, “catheter” and “urinary catheter” are used synonymously to a great extent.
The present invention describes in particular the application-optimizing connection of a urinary catheter to a removable insertion element inserted into the urine-draining lumen of the catheter, which insertion element stabilizes the catheter shaft for the urethral insertion and allows the user-friendly intra-urethral insertion of lubricating or lumen-straightening gel. The simple handling of the catheter is provided for within the scope of the invention by corresponding structural modifications and ancillary additions. In particular, the invention offers the possibility of a catheterization guided by one single hand, which in an optimal case includes the lubrication of the catheter tip, the insertion of the front third of the catheter, the lumen-straightening of the urethra through the application of gel, the successive pushing forward of the catheter with a tong-like gripper element, and the blocking of the retention balloon. The special design of the device according to the invention allows the scope of a catheter set to be kept to a minimum.
The invention furthermore describes the especially atraumatic design of all components of a urinary catheter that are placed intracorporally. In particular, the catheter shaft is supposed to be as tissue-friendly as possible, and behave in a way that avoids erosions in the urethra. Perforating injuries to the dome of the bladder from the tip of the catheter are supposed to be prevented. The catheter balloon should have the best possible retaining and nestling sealing effect in the region of the urinary outlet, wherein an eroding effect of the balloon wall on the epithelium is as low as possible. The lumen of the catheter shaft draining the urine is supposed be optimally large. Moreover, the pooling of residual urine in the bladder is supposed to be minimized.
The invention describes in particular a combination of a shaft tube, which is indwelling in an atraumatic manner in the urethra, designed to be thin-walled and/or have a large lumen, and drain urine effectively, with an insertion aid inserted into the thin-walled shaft tube, which insertion aid facilitates the release near the tip of a lubricating and/or lumen-straightening substance into the urethra along with the stabilizing reinforcement of the catheter shaft that is required for catheter placement. After securing the catheter by filling the catheter balloon, the insertion aid is pulled out of the catheter lumen so that a most malleable, friction-minimizing tube body possible comes to lie in the urethra, which prevents the typical, erosion-induced lesions of the urethra in the case of conventional catheterization.
In the preferred construction as a hose-like or tubular body, the insertion aid comprises an inner lumen measuring approx. 1.0 to 3.0 mm, through which a lubricating and/or lumen-straightening substance is released in the region of the tip of the urinary catheter accommodating the insertion aid. In the process, the respective substance exits as close as possible to the urine-draining opening of the urinary catheter spaced apart in the draining lumen of the catheter. As an alternative, the tip of the insertion aid can reach in an axial extension of the catheter portion indwelling in the bladder, beyond an outlet of the catheter shaft opening towards the front. With such a design, the insertion aid can be provided in the region of its tip with one of the many tip formations that are common in transurethral catheterization, and which facilitate the passage of the catheter through critical bends in the progression of the urethra. In this case as well, the insertion element comprises an inner lumen for the application of a lubricating and/or lumen-straightening substance, wherein the release in this case takes place directly from an opening of the insertion element into the urethra. Following the securing of the catheter in the bladder, the insertion aid is removed. After the insertion aid is retracted, in the preferred case, a funnel-like outlet adjusts in the front balloon radius of the catheter balloon, wherein the opening of the catheter shaft is spontaneously positioned at the base of the funnel during the filling of the balloon.
Alternatively, the catheter shaft can comprise a short, spout-like tip formation, which, however, is designed in such a way that it does not project beyond the front radius of the balloon in a balloon that has been placed in situ.
Furthermore, the invention describes a special formation of the catheter tip, which comprises a corrugated-tube-like wall formed to be corrugated, which makes the tip freely rotatable or bendable in every direction, and thereby, on the one hand, simplifies the passage through the urethra, and, on the other hand, allows the tip to be bent axially on all sides within the bladder, so that the dome of the bladder does not get irritated and damaged by a formation pointing sharply at it when it is resting on the distal end of the catheter.
The balloon body is preferably formed as flat or discoid as possible in the case of all embodiments of the device according to the invention in order to reduce the formation of residual urine.
In line with an optimally simplified handling during the catheterization, the lubricating and/or lumen-straightening substance can be injected in a first handling step into a hood-like or bag-like sheath, which is seated on the distal end of the catheter or the distal end of the insertion aid with a narrow, intermediate gap space and which distributes the substance as uniformly as possible in this gap space around the catheter tip or the distal end of the catheter. The sheath is then removed towards the front immediately before insertion of the catheter into the urethra.
The reinforced catheter that is stabilized by the insertion aid is inserted approximately 8 to 10 cm into the male urethra in a manner that is guided in a quasi piercing manner. In order to facilitate the further passage of the catheter in an optimally atraumatic manner, following the insertion of the front catheter section, a second gel quantity is injected into the urethra which straightens the lumen of the organ and thus prevents injuries in particular there where the male urethra takes an especially curve-like winding course.
The occlusion of the drainage lumen from deposits of urine components is counteracted in the course of the invention by a maximally large-lumen design of the urine-draining lumen. For this purpose, the wall of the transurethral segment of the catheter is reduced as far as possible, in an extreme case to the film thickness. In order to prevent lumen-occluding kinks or twisting of such a thin-walled shaft, said shaft can be provided with a lumen-stabilizing, corrugated-tube-like profile over the entire length, or even in only specific, mechanically relevant sections. In conjunction with materials having a high elastic restoring force, such as e.g., polyurethane, a shaft with a such a profile can be provided with spontaneously lumen-straightening properties, which facilitate namely an elastically acting, malleable bending of the shaft, as well as ensure an easy to effectuate transient, radial collapse of the lumen, but, on the other hand, a reliable, spontaneously lumen-straightening and disentangling effect.
In addition, in combination with tubular-film-like, thin-walled shaft walls, for example rod-like, hose-like, tubular-mesh-like structures are also conceivable, which run freely in the interior of such a drainage tube in a torsion-inhibiting, stabilizing manner.
The invention uses preferably specially formed balloon components, which are described for example in PCT/IB2015/002282. These balloons manufactured from micro-thin-walled, but simultaneously highly dimensionally-stable flexible film are preferably filled incompletely, only flaccidly with air. Due to the placement in a flaccid, unexpanded state, abrasions of the epithelium lining the bladder that have a traumatic effect can be prevented to a large extent. In the case of an unexpanded, flaccid filling of the balloon, only the respective force acting in the bladder will be absorbed by the balloon. The filling pressures are thereby in a low millibar range. In an unloaded state of the balloon, they do not or only slightly exceed the intravesical pressure prevailing in the bladder or the patient.
As described in PCT/IB2015/002282, a balloon of this type can also be provided with a urethral extension formed cylindrically and with a tapered diameter. The retaining, vesical balloon portion in this case merges proximally into a sealing, urethral balloon portion. The combined, vesical-urethral balloon body is provided in the urethral segment preferably with a “residual” diameter, which exceeds the diameter of the lumen of the urethra by approximately 0.5 to 1.5 times, preferably by 0.5 to 1.0 times. The balloon portion whose diameter is over-dimensioned in this way is thereby applied to the urethral wall in a tension-free manner that is largely independent of size, under the formation of a radially oriented fold or invagination of the sheath wall. The residual excess ensures that all portions of the urethra can be sealed in a flaccidly tamponaded manner. In addition, diameter fluctuations of the urethral lumen can be balanced out through the residual diameter.
As an alternative, less preferred design, the urethral portion of the formed balloon body can be dimensioned in such a way that it essential corresponds to or exceeds the diameters of the respective urethra.
The filling of the catheter balloon used according to the invention takes place preferably with a gaseous medium or with air. The supply of the filling medium takes place via a supply line integrated into the shaft wall, but can also take place through supply lines that run freely in the shaft lumen.
The invention also takes less preferred designs into consideration that dispense with the described, preformed balloon components and instead comprise conventional, retention components that stretch elastically from a tube section.
The indwelling part and the insertion aid can be made of materials which have the same hardness. However, design variants are preferred in which the materials for the indwelling part and for the insertion aid differ from each other at least in terms of their hardness.
Because both parts are made of plastics, preferably of thermoplastics or thermosetting plastics or elastomers, the material hardness is preferably measured as Shore hardness. The hardness values in this case are especially preferably Shore A or Shore D.
The Shore hardness y of the material of the insertion aid should correspond or exceed that of the Shore hardness x of the material of the indwelling part:
y=x
or
y>x
or
y≥x.
The difference in the Shore hardnesses, in particular the hardnesses according to Shore A, should be defined as follows:
y−x≥0
or
y−x≥1
or
y−x≥2
or
y−x≥5
or
y−x≥10
or
y−x≥20.
A method according to the invention for the catheterization of the bladder of a patient is characterized in that a lubricating and/or lumen-straightening substance is released from a compressible reservoir vessel as a result of a digital or manual compression of the reservoir vessel.
In the process, a prepared, ready-to-use catheter device is used, which is made of a shaft-shaped indwelling part that can be placed in the bladder and in the urethra that drains in the manner of a catheter and has a drainage opening in the region of the distal tip of the shaft, and a retractable insertion aid that is inserted into the shaft-shaped indwelling part, which facilitates insertion into and passage through the urethra, and has a tubular or hose-like construction with an apical opening for terminal release of the lubricating and/or lumen-straightening substance, on whose proximal end the reservoir vessel is connected to or can be connected to the lubricating and/or lumen-straightening substance.
Various embodiments of the urinary catheter device according to the invention are described in the enclosed figures, along with combinations with special, functional accessory components for carrying out the catheterization with one hand. They show:
Located at the proximal end of the insertion aid in the preferred design is a reservoir-like, preferably folding-bellows-like reservoir vessel 8, which accommodates the substance to be supplied and from which the substance is preferably conveyed by expressing or squeezing the vessel towards the tip of the catheter. In its preferred design, in the case of the effect of an axially compressing or alternatively even a radially squeezing force, the vessel transitions into an axially or radially locking state, which prevents an elastic reestablishing of the vessel when the acting force diminishes. An aspiration of the already applied gel back into the vessel can thus be prevented.
For an improved fastening of the relative position of the catheter and insertion aid, the distal part of the vessel 8 has a cone-like segment 9, which can be inserted into the connector 10 of the catheter with a custom-fit and in an optionally locking manner.
The tip 7a of the insertion aid can comprise, in the transition to the distal end 5 of the catheter shaft, a special bulge-like thickening 7b, which slims down elastically under axial tensile force, and thus, during retraction, slides out of the relative position in the transition to the catheter tip. The bulge 7b can be provided optionally with longitudinal, strip-like weakenings, which when overcoming a specific tensile force lead to the collapse of the bulge and thus facilitate the retraction of the bulge-like formation through the lumen of the catheter. The bulge 7b forms in conjunction with the front opening 5 of the catheter an atraumatic transition that is as stepless as possible. Furthermore, the bulge makes it possible for the substance, which is applied into the urethra during catheter placement, to accumulate in front of the distal catheter end 5 and be able to be pushed along in front of the catheter end so that it remains available in an adequate quantity during the urethral passage of the catheter in the region in front of the catheter tip. Particularly during the application of gels, an optimally lumen-straightening effect can be achieved when inserting the catheter into the urethra.
b. A corresponding corrugated profile 7c can be formed also in the region of the catheter tip 5 of the urinary catheter shaft. Placed in situ, the tip can bend into an laterally bent position P, whereby a direct irritation acting in a piercing manner and, during long-term placement, an ulcerating lesion of the dome of the bladder where the tip rests can be prevented.
The insertion aid is made preferably of a material having good sliding properties, which is crucial for the comfortable retraction from the indwelling part of the device. To achieve this sliding ability, the base material used can be provided for example with a wax additive, which develops a film on the surface that reduces the frictional resistance.
For example, the shaft formed in a corrugated manner can comprise the following features: outer diameter of 6.0 mm, inner diameter of 5.4 to 5.9 mm, preferably 5.6 to 5.8 mm, polyurethane of Shore hardness 85A or 90A, corrugation amplitude of 1.0 to 1.5 mm, and peak-to-peak distance of the corrugation of 0.5 to 1.5 mm.
In order to prevent lumen occluding kinks and torsions of the tubular film 14, this is supplemented for example with a preferably free internal, rod-like, tubular or hose-like element SE1, which is depicted at the top in
On the other hand, in order to stabilize a tubular-film-like, thin-walled shaft tube 14, the wall thereof can also be reinforced by a net-like structure SE2 for example, which is preferably applied to the inner surface of the shaft 14 in a planar and permanently connected manner. A corresponding net-like mesh SE2 can also be permanently installed between two coaxially arranged tubular film layers, for example be coextruded with said layers. Instead of a net-like mesh, a spiroidal arrangement can also be used, or another planar arrangement with adequate self-straightening properties.
Precisely these self-straightening properties impart the otherwise very flexible tubular film 14 with the ability to resist tendencies to kink and/or reduce or reset any torsions of the tubular film 14 that occur. Both measures serve to keep the lumen open inside the film-like tubular film 14.
Along with a colored marking of folding bellows segments, differently designed sections of the reservoir vessels, in particular differently configured segments of a folding bellows, can make a tactilely detectable or oriented partial quantity release possible. For example, the proximal bellows folds directly adjacent to the base of the bellows can be designed to be more smoothly compressible or compressible with lower resistance in relation to the distal bellows folds, so that, after an initial compression of the folding bellows for releasing a first partial quantity of the lubricating and/or lumen-straightening substance from the proximal segment of the bellows, the user perceives a palpable increase in resistance when transitioning to the distally adjacent folding bellows segment, which signals to him or her that the first partial quantity has been released, and the distal end of the catheter device should first be inserted into the urethra before releasing the second partial quantity of the lubricating and/or lumen-straightening substance.
Immediately before inserting the catheter into the urethra, the hood is then pulled off towards the front of the catheter by means of a closure element fastened apically to it. To prevent the film hood from being inserted unintentionally into the ostium, the hood is preferably provided apically with an approximately thumb-sized prolongation that is leaf-like for example, which furthermore facilitates the removal or the pulling off of the cap.
In particular the gel vessel 8 is positioned in the clasp or in the handle piece in such a way that it can be condensed or compressed easily by the user. The filling vessel for blocking the balloon can be arranged adjacent to the gel vessel. It can be compressed or squeezed in an appropriate manner by thumb pressure. A balloon-like design that is filled with air can be embedded for example in a spoon-like depression 24 of the clasp or of the handle and rest there virtually on an abutment.
To ensure that the catheter is protected from contamination during placement of the catheter, the holding device is equipped with a thin-walled, bag-like film 27. In the process, the bag film protects in particular the catheter section, which extends from the gripping tweezers or tongs 25 to the connector of the catheter device. The protecting bag is designed for accommodating the looped, centric catheter shaft. The film protection makes it possible for the user to dispense with putting on sterile gloves and insert the catheter equipped or fastened in the holding device according to the invention in a sterile manner.
Once the roughly first ten centimeters of the catheter shaft, which are moistened with a lubricating substance, are inserted into the urethra, the catheter shaft in the clamp is released by releasing the rocker, and it can then be displaced proximally towards the shaft, where the clamp again grips the shaft in the case of pressure on the rocker. The catheter shaft can thus be pushed forward by the user successively into the urethra in the manner of a tweezer-like of tong-like guidance. Once roughly two thirds of the shaft length is inserted into the urethra, the catheter is secured by filling the balloon, and the catheter is removed completely from the fastening deep-drawn parts or formations of the holding device.
The invention moreover describes a method for catheterization the bladder of a patient, wherein the number of components required for the cleaning and insertion process is kept to a minimum. The described ready-to-use, prepared catheter device according to the invention is advantageously combined for this purpose with a surgical drape 28 designed in a glove-like manner to directly grip the penis or spread open the labia, which surgical drape, like the catheter device, is designed in a special manner for a one-handed handling. In conjunction with the two functional units (glove/drape and catheter device), the user is able to carry out the entire catheterization process without a person assisting them.
The two functional units are packaged together in a set. After opening the outer packaging of the set, the user uses their hand to grip directly into the surgical drape unit that is designed in a glove-like manner and thereby take it out of the set. The user then directly grips the penis or spreads open the labia. They thereby achieve an optimally protective position of the drape vis-a-vis the orifice to be cleaned and then catheterized. Then they fold the lateral portions of the drape as needed and fasten them to the abdomen, leg or on the buttocks of the patient using the corresponding self-adhesive surfaces.
As a special feature, the glove/drape 28 optionally comprises blister-pack-like, deep-drawn film compartments 34 that are integrated into the drape, and are opened by tearing open or peeling off a protective film 35 with the free hand, and contain ready-to-use swabs that are saturated with antiseptic for cleaning the skin and mucous membranes. The swabs are picked out the blister pack at a stamp-grip-like formation, which is protected by the sealed deep-drawn film and thereby allows the user to grip in a direct and contamination-free manner. The swabs can then be discarded on the surgical drape or in a pocket-like formation attached thereto.
After cleaning has been carried out, the user then grips the catheter device with their free hand and inserts the distal catheter portion that is lubricated with gel and stabilized by the insertion aid, reinforced by the insertion aid and guided by the holding device in a lance-like manner into the urethra. Using thumb pressure, they then apply the substance still remaining in the reservoir vessel into the urethra and move the catheter by successive gripping and releasing of the catheter shaft with the clamp of the holding device into the bladder. During insertion of the catheter, the user adjusts the penis into the respective optimal position via the surgical drape using a direct grip or they keep the labia optimally open by digital spreading.
Once the first two thirds of the catheter are inserted into the urethra, the balloon of the catheter is blocked by pressing the filling vessel with the thumb. Then, the hand is removed from glove/drape combination and the proximal catheter portion is retracted from the holding device.
The insertion aid is then retracted from the device and the filling vessel is removed from the catheter valve. The catheter is then connected to a urine-draining hose/bag unit.
The retaining balloon component of the urinary catheter is preferably formed by blow molding from a polyurethane tube blank that was previously blow molded in a separate manufacturing step, preferably in a durometer range of Shore 80A to 95A, especially preferably between 85A and 90A. The wall thickness is preferably 5 to 25 μm, especially preferably 7 to 12 μm. When using material types such as for example PUR of the Elastollan 1100 group from BASF or PUR of the Pellethane 2363 type from Lubrizol, flexible film-like structures can also be blown out of pre-extruded material using blow molding, which structures connect the lowest wall thickness with high dimensional stability in an ideal way. Particularly in the case of a high axially directed outward tensile force effect, micro-thin PUR balloon components ensure a reliable anchoring effect.
In addition to polyurethane, the balloon element can also be fabricated less preferably of comparable flexible films of alternative materials, such as for example polyethylene-based mixtures or TPE-based raw materials. Furthermore, co-extruded starting materials that combine for example PUR and PVC in a coaxially extruded manner in the raw tube are conceivable for the blow molding.
Likewise less preferred, it is also possible to use conventional sleeve-based, non-preformed balloon elements that are to be elastically expanded.
Number | Date | Country | Kind |
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10 2019 006 229.9 | Sep 2019 | DE | national |
This patent application claims benefit of International (PCT) Patent Application No. PCT/IB2020/058241, filed 4 Sep. 2020 by Creative Balloons GmbH for DEVICE AND METHOD FOR URETHRAL APPLICATION OF A LUBRICATING AND/OR LUMEN-STRAIGHTENING SUBSTANCE THROUGH A RETRACTABLE INSERTION AID, which patent application, in turn, claims benefit of German Patent Application No. DE 10 2019 006 229.9, filed 4 Sep. 2019. The two (2) above-identified patent applications are hereby incorporated herein by reference.
Filing Document | Filing Date | Country | Kind |
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PCT/IB2020/058241 | 9/4/2020 | WO |