Patent Application
20100049166
This disclosure relates to a medical product for treatment of sinusitis, and a set for producing the medical product.
Sinusitis, or inflammation of the paranasal sinuses, is one of the most common clinical pictures presented in the population. Approximately 15% of the population of the western industrialized nations suffers from chronic inflammation of the paranasal sinuses. Those affected almost always feel very unwell. Typical symptoms include headache, cough, fever, restricted breathing through the nose, and an impaired sense of smell and taste.
Sinusitis often develops from rhinitis, when the discharge of secretions from the paranasal sinuses is obstructed by swelling of the mucous membranes or by anatomical circumstances. The resulting accumulation of secretions represents an ideal breeding ground for microorganisms. Sinusitis is in most cases triggered by viruses, for example rhinoviruses, adenoviruses or RS viruses. An impaired immune defence then often leads to a secondary bacterial infection or what is referred to as a bacterial superinfection. The bacterial pathogens are in most cases Haemophilus influenzae and Streptococcus pneumoniae.
Various therapeutic measures are presently available for the treatment of sinusitis. The main aim of therapy is to reduce the inflammation as far as possible and restore the natural mucosal discharge of the paranasal sinuses. Nose drops that reduce swelling are often used. These act quickly on the nasal obstruction, but only for a short time and for a maximum of 8 hours. Moreover, the use of nose drops often results in what is known as a rebound effect, i.e., a reactive swelling of the mucous membrane after the effect wears off. Frequent use of nose drops also poses the risk of rhinitis medicamentosa or a nose disease induced by nose drops. In addition, frequent use of nose drops and nasal sprays poses a risk of habituation.
In addition, antibiotics are also used for treatment of paranasal sinusitis. A disadvantage is that the healing process may be quite protracted despite the administration of antibiotics. Moreover, purulent inflammatory secretions that are already present are not transported away from the paranasal sinuses by this therapeutic measure. In addition, some difficulties are typically associated with the administration of antibiotics.
In particularly serious cases of sinusitis, surgical measures are available, for example, to permit discharge of secretion that has been rendered difficult by organic elements. For example, an operation can be carried out to remove the polyps, the nasal concha can be made smaller, bone can be scraped off or the nasal septum straightened.
Gauze bandages are also used in some cases to drain the paranasal sinuses. However, the use of gauze bandages has proven awkward and has also been found to be ineffective in carrying off purulent nasal secretions.
It could therefore be helpful to make available a medical product for treatment of sinusitis that avoids the known disadvantages of current therapeutic measures and that especially permits effective and rapid removal of purulent secretions accumulated in the paranasal sinuses.
We provide a medical product for treatment of sinusitis including an absorption body for bodily fluids.
We also provide a set for producing the medical product, including an absorption body for bodily fluids and a drainage tube.
We further provide a method of treating sinusitis with the medical product, including a) placing the medical product into the paranasal sinuses of a patient and b) applying an underpressure to the medical product and to the paranasal sinuses via a drainage tube.
Further features and details will become evident from the following description of preferred aspects in the form of descriptions of figures. The figures are here made, by express reference, part of the content of the description. The individual features can be realized either singly or severally in combination. The figures, including the associated description of the figures, serve merely to illustrate our disclosure and are not in any way intended to limit that disclosure.
In the schematic figures:
It will be appreciated that the following description is intended to refer to specific examples of structure selected for illustration in the drawings and is not intended to define or limit the disclosure, other than in the appended claims.
We provide a medical product comprising an absorbent shaped body or an absorption body for treatment of sinusitis. Particularly advantageously, the absorption capacity of the absorption body for bodily fluids, in particular for pathological accumulations of fluid, preferably purulent secretions, is sufficiently great to achieve therapeutically satisfactory drainage of purulent paranasal sinuses. This applies in particular to chronically purulent paranasal sinuses. The absorption body can be adapted particularly advantageously in terms of its size and form to the paranasal sinuses of the individual patient.
“Drainage,” as sometimes used herein below, is intended to be understood as the removal of bodily fluids, in particular pathological accumulations of fluids, especially purulent fluids, from the paranasal sinuses.
In a preferred aspect, the absorption body is designed at least partially, preferably completely, with open pores. If the absorption body is designed completely with open pores, the bodily fluid to be taken up by it can penetrate rapidly into the absorption body. The absorption body can in principle have a pore size of between about 200 and about 1200 μm, for example of between about 200 and about 350 μm. The absorption body preferably has a pore size of between about 400 and about 950 μm, in particular of between about 650 and about 950 μm. An absorption body made of polyurethane can, for example, have a pore size of between about 400 and about 600 μm. By contrast, the pore size of an absorption body made of polyvinyl alcohol can be between about 200 and about 1000 μm.
The absorption body particularly preferably has an absorption capacity for bodily fluids that corresponds to about 10 to about 100 times, in particular about 20 to about 40 times, its dry inherent weight. In the case of sinusitis, the bodily fluids to be taken up are generally purulent nasal secretions. To increase the absorbency of the absorption body, it can contain further additives, in particular superabsorbents, for example crosslinked polyacrylic acid salts or crosslinked polyelectrolytes. The advantage lies in the rapid uptake of large quantities of purulent secretions, and thus of microorganisms, by the absorption body, and these can then be removed from the paranasal sinuses together with the absorption body. This results in what is generally a favorable healing process.
In another aspect, the absorption body is designed to be elastic or reversibly compressible. This means that the absorption body can be compressed by the action of a force and largely recovers its original shape after termination of the force. In this way, the absorption body can particularly advantageously be inserted in compressed form into the paranasal sinuses and positioned therein, for example, with the aid of a delivery sleeve or trocar. After the delivery and positioning of the absorption body, the latter can then deploy or extend again to its original shape. The absorption body can in this way substantially fill the paranasal sinuses and substantially cover the inside walls thereof.
In a further aspect, the absorption body is a sponge body or foam body, preferably an open-cell sponge body or an open-cell foam body. A sponge body is particularly preferred. A medical sponge body for treatment of abscesses in other body cavities is known from WO 2004/041346 A1, the subject matter of which is incorporated herein by reference.
In yet another aspect, the absorption body is composed of a polymer, in particular a synthetic polymer. The polymer can be a homopolymer or copolymer, in particular a block copolymer. A copolymer is to be understood as a di-, tri-, tetra-polymer or the like. The polymer can also be resorbable, partially resorbable or non-resorbable. The use of a non-resorbable polymer is preferred. The absorption body is preferably made from at least one of a polymer from the group polypropylene, polyethylene, polyvinyl alcohol, polyethylene terephthalate, polyurethane, and copolymers thereof.
In a particularly preferred aspect, the absorption body is made of polyurethane or a polyurethane derivative, in particular polyurethane ether. The polyurethane can be an aliphatic polyurethane. The polyurethane is preferably a linear aliphatic polyurethane. The polyurethane itself can be composed of macromolecular and/or low-molecular-weight aliphatic diols and aliphatic diisocyanates. Macromolecular diols that can be used are, in particular, polycarbonates, in particular 1,6-hexanediol polycarbonate. Low-molecular-weight diols that can be used are, for example, 2,2,4-trimethyl hexanediol, 2,4,4-trimethyl hexanediol and/or 1,4-butanediol. The aliphatic diisocyanates are preferably cycloaliphatic diisocyanates, in particular 4,4-dicyclohexylmethane diisocyanate or 1,4-cyclohexyl diisocyanate. The polyurethane can be produced from various diols and/or diisocyanates. For further possible polyurethanes, reference is made, for example, to DE 36 43 465 A1, DE 33 18 730 A1 and DE 41 07 284 A1, the subject matter of which is incorporated herein by reference. Polyurethane is particularly preferred as material for the absorption body by virtue of its biocompatibility.
As has already been mentioned, the absorption body is usually placed in the paranasal sinuses by a suitable delivery instrument, for example, a trocar. When the absorption body has taken up the bodily fluids located in the paranasal sinuses, or when the absorption capacity of the absorption body is reached, the absorption body can in principle be removed from the paranasal sinuses using a gripping instrument suitable for this purpose, for example, tweezers, dressing forceps or foreign-body forceps.
In a particularly preferred aspect, the medical product comprises a drainage tube in addition to the absorption body. In other words, the medical product in this construction comprises an absorbent shaped body or absorption body and a drainage tube. Preferably, the absorption body comprises a drainage tube. The drainage tube may be directly connected to the absorption body. The drainage tube serves particularly advantageously for withdrawing or draining off the quantities of fluid absorbed by the absorption body. In this way, the original absorption potential or absorption capacity of the absorption body can be restored. The absorption body may be used particularly advantageously for suction drainage, the suction preferably being generated outside of the paranasal sinuses. The medical product is preferably used in the context of vacuum therapy. For this purpose, an underpressure is generally generated at a free end of the drainage tube, by the free end of the drainage tube being attached to a suitable source that generates an underpressure. This is done in most cases by attaching the drainage tube to a suction or vacuum pump. In this way, the bodily fluids that are suctioned can be withdrawn rapidly from the absorption body. The vacuum pump is particularly advantageously a portable electronic vacuum pump. In this way, the patient's mobility is not restricted during treatment. The medical product can remain in the paranasal sinuses of the patient for several hours, if appropriate for several days. For instance, the medical product may be replaced after about 8 to about 72 hours. In principle, the drainage via the drainage tube can take place at defined intervals. However, it is particularly preferable if the bodily fluids absorbed by the absorption body are withdrawn or drained off continuously. The quantities of fluid withdrawn are usually collected in specially provided collecting containers, for example canisters or vacuum flasks. The collecting containers are generally arranged upstream of the aforementioned suction pump or vacuum pump and communicate with the latter via suitable connecting tubes. A filter can be provided between the collecting containers and the suction or vacuum pump to avoid contaminating the suction or vacuum pump.
The absorption body is preferably connected in one piece to a drainage tube. In this aspect, the proximal end of the drainage tube is connected to the absorption body, whereas the distal end of the drainage tube is free and can, for example, be attached to a suction pump, vacuum pump or the like. Provision is made in particular for the absorption body to be formed integrally onto a drainage tube. For example, the absorption body can be adhesively bonded, sewn or welded to a drainage tube or can be foamed onto a drainage tube. Part of the drainage tube generally protrudes into the absorption body. For this purpose, the absorption body preferably has a substantially cylindrically shaped through-channel. The latter generally extends approximately centrally through the absorption body, in the longitudinal direction thereof, and expediently has a diameter adapted to the diameter of the drainage tube. The part of the drainage tube protruding into the absorption body or enclosed by the absorption body preferably has openings. In this way, a uniform underpressure can particularly advantageously be generated on the whole of the absorption body. Moreover, more rapid drainage of the fully soaked absorption body is possible via the openings.
The drainage tube itself is preferably made of a material impermeable to liquid. For example, the drainage tube can be a plastic tube, in particular a polyethylene tube.
The medical product may comprise a drainage tube formed by a portion of the absorption body enveloped in a liquid-tight manner. The enveloped portion is preferably tubular. The envelope can be a film, in particular an adhesive film. The envelope can be formed by a hot-melt adhesive, for example. The hot-melt adhesive can be resorbable or non-resorbable. Examples of hot-melt adhesives may be selected from the group consisting of polyglycolides, polylactides, polydioxanones, polycaprolactones, copolymers, polymer blends, and polymer mixtures resulting therefrom.
The medical product, preferably the absorption body, may comprise an irrigation tube. In a particularly preferred structure, the medical product, preferably the absorption body, comprises a drainage tube and an irrigation tube. The irrigation tube can be used to irrigate the absorption body. Examples of irrigation liquid that can be used are a saline solution, a buffer solution or an anti-inflammatory solution. The absorption body can additionally be irrigated using a disinfecting liquid or using a liquid, in particular a solution, that has an antimicrobial action to remove or kill microorganisms. Alternatively, the irrigation liquid can itself contain disinfecting or antimicrobial substances. The irrigation liquid can additionally contain odour-inhibiting additives to avoid or combat odors. The absorption body is generally irrigated after the bodily fluids taken up by it have been removed from the absorption body. For further features and details of the irrigation tube, reference is made to the described structures of the drainage tube.
The absorption body may contain antimicrobial substances, antibiotics, disinfectants, odor-inhibiting and/or anti-inflammatory substances. For example, the absorption body can contain cyclodextrins to inhibit or combat odors. Examples of antimicrobial substances that can be used are substances from the group including triclosan, polyhexamethylene biguanide (PHMB), zinc, copper and silver, in particular particles, preferably nanoparticles, thereof. The aforementioned substances or materials can be present homogeneously, i.e., uniformly distributed, in the absorption body. It is also possible for the absorption body to have a surface coating composed of the active substances listed in this paragraph.
The absorption body can be present in different forms. Thus, the absorption body can be adapted in form and size starting from a basic form. It is particularly advantageous for the absorption body to be adapted in terms of its length and form to the dimensions of the paranasal sinuses of the individual patient. The absorption body can be spherical, cuboid, square, tubular, cylindrical or the like. It is preferable for the absorption body to be tubular or cylindrical.
The medical product can be used to treat acute sinusitis and also chronic sinusitis. In acute sinusitis, the maxillary sinuses and frontal sinuses of the patients are in most cases also affected, whereas chronic sinusitis additionally involves the ethmoidal sinuses. As has already been mentioned, the absorbency properties of the absorption body mean that the medical product is particularly suitable for taking up large quantities of bodily fluids, preferably purulent nasal secretions, which collect in particular over a long period of time in the paranasal sinuses of patients. For this reason, the medical product is suitable in particular for the treatment of chronic sinusitis. It is also possible for the medical product to be used for prevention of sinusitis.
The medical product may also be designed as a drainage product or drainage article for the treatment of sinusitis.
We also provide a set for producing a medical product. The set comprises an absorbent shaped body or absorption body for bodily fluids, in particular for collections of purulent secretions in the paranasal sinuses, and preferably a drainage tube. In addition, the set can comprise a delivery instrument, in particular a delivery sleeve or trocar, for delivering the absorption body to the paranasal sinuses and, if appropriate, for placing the absorption body in the paranasal sinuses. Moreover, the set can also comprise an irrigation tube for irrigating the absorption body and/or an underpressure source or vacuum source, for example, a suction pump, for accelerated withdrawal of the bodily fluids taken up by the absorption body. An underpressure source or vacuum source is generally attached to a drainage tube to drain the absorption body. This is usually done at an underpressure or suction of between about 500 and about 800 mbar (corresponding approximately to 375 mmHg to 600 mmHg). For further features and details, especially of the medical product, absorption body and drainage tube, reference is made to the preceding description.
We also provide for the use of the medical product for the manufacture or production of a drainage product or drainage article for the treatment of sinusitis, in particular of chronic sinusitis. For further features and details of this reference is likewise made to the preceding description.
We still further provide for the use of an absorbent shaped body or absorption body, and preferably of a drainage tube, for producing a medical product for treatment of sinusitis. For further features and details of this, in particular of the absorption body and drainage tube, reference is likewise made to the preceding description.
We still further provide a method for treating sinusitis, in particular chronic sinusitis, comprising:
a) placing a medical product, which comprises an absorption body, into the paranasal sinuses of a patient, and
b) applying an underpressure to the medical product and to the paranasal sinuses via a drainage tube.
The drainage tube may be connected to the absorption body before placing the medical product into the paranasal sinuses.
The medical product may also be placed into the paranasal sinuses by a delivery instrument, in particular by a trocar, and the delivery instrument is preferably removed from the paranasal sinuses before the underpressure is applied. A suction pump or vacuum pump is preferably used to apply the underpressure. An underpressure of between about 500 and about 800 mbar is generally used. Provision can be made for the medical product to be irrigated, preferably via an irrigation tube, upon termination of the underpressure. For further features and details of the method, reference is made to the preceding description.
The medical product 30 depicted in
