The present disclosure relates to a bipolar HF applicator for an HF surgical instrument as well as to an HF application system.
Chronic rhinitis includes allergic rhinitis, nonallergic rhinitis and mixed sub-types. While the clinical manifestation can be different, watery rhinorrhea and nasal obstruction are dominating symptoms that negatively influence the quality of life of a patient and can cause him to seek treatment. Medication treatments for chronic rhinitis are considered the first choice. However, not all patients respond sufficiently to the available medication treatments and require in some circumstances procedural or surgical interventions for persistent chronic rhinitis.
In the past, neurectomy of the nervus vidianus was the method of choice for refractory, meaning therapy-resistant, rhinitis, while relatively newer technical studies have described the role of the posterior nasal neurectomy. Multiple systematic overviews that have recently been published have investigated the basis of evidence for the surgical treatment of chronic rhinitis. Although the vidian neurectomy appears to be effective, there are serious disadvantages, including the potential nasal and ocular morbidities and the increased healthcare costs and resources in connection with general anesthesia and surgical procedures.
The pathophysiology of chronic rhinitis is complex and includes both sensory and autonomous nerve pathways. Sensory nerve pathways detect specific allergens or irritants, which stimulate a parasympathetic reaction via the nervus vidianus. It has been shown that methods such as the vidian neurectomy reduce the symptoms of chronic rhinitis. However, side effects such as dry eyes due to the ablation of the parasympathetic innervation of the lacrimal gland have been found. The hypothesis has been proposed that the ablation of the posterior nasal mucous membrane or respectively the posterior nasal nerves (Rr. nasales posteriores) can reduce the side effects of dry eyes in a vidian neurectomy. Targeted therapies for this region that can offer relief of chronic rhinitis symptoms with limited side effects are therefore desired.
Due to its simple nature, cryotherapy has gained interest. In cryotherapy, liquid nitrogen is used to ablate posterior nasal tissue. Through extremely low temperatures, cryotherapy forms ice crystals and induces a cell contraction to then lyse the cells. An example of this is “ClariFix” by Arrinex, Inc. The cryotherapy device uses liquid nitrogen to generate very low temperatures. During the freezing process, the device does not receive a response regarding the tissue effect in order to adjust the temperature or the application time.
Another possibility to temporarily or permanently restrict the function of the posterior nasal nerve (PNN) is the use of radio frequency current. With this type of energy, the tissue is not frozen but heated. A known device for HF ablation of the posterior nasal nerve includes multiple wires as electrodes on the distal tip of an elongated insertion part.
The object of the present disclosure is to provide a bipolar HF applicator and an HF application system that allows a safe and efficient temporary or permanent restriction of the function of the posterior nasal nerve.
This object is solved by a bipolar HF applicator for an HF surgical instrument, with a flat main body made of an insulating material, that has a rounded, in particular round or elliptical, shape with two side faces opposite each other and an edge delimiting the side faces, wherein the main body has, on at least one of the two side faces, two electrodes, the electrode surfaces of which are isolated from each other on the side face, wherein the electrodes are connected to supply lines for supplying HF energy.
The bipolar HF applicator according to the present disclosure avoids the problems that arise in the use of thin wires as electrodes, as occurs in known devices for HF ablation of the posterior nasal nerve that include multiple wires as electrodes on the distal tip of an elongated insertion part. With thin electrode wires, a local dehydration of the tissue that is in contact with the electrode wires occurs. The dehydration leads to a reduction in the efficiency of the treatment in that the change of the impedance of the tissue ends the ablation early.
In contrast to this, the electrodes in the bipolar HF applicator according to the present disclosure are arranged on a side face or on both side faces of a flat main body made of an insulating material and occupy a configuration distributed over the side face, which leads to a significantly less localized energy input into the treated tissue as is the case with wired-shaped electrodes. Accordingly, the degree of dehydration is considerably lower and the treatment is more effective.
The HF applicator according to the present disclosure can be inserted through the nose into the nasal cavity and into the region of the posterior nasal nerve during an operation. Supplying HF energy causes heating of the tissue against which the electrodes of the HF applicator lie and to a sclerosing of the near-surface nerve tissue. The applicator can be used in a very targeted manner and leads to less destruction of tissue than wire electrodes. The HF applicator can have a circular shape, but also an elliptical or other shape with rounded corners. The greatest extension of the HF applicator, for example its diameter, is in the range of several millimeters, in particular preferably between 2 and 12 mm, in particular between 3 and 8 mm.
The HF applicator according to the present disclosure has only two electrodes. These can be easily connected to a bipolar standard output socket of an electrosurgical generator. For optimum treatment results, the generator can have an impedance/resistance feedback function in order to give the surgeon a signal when the coagulation process is completed. However, it would also work with a standard bipolar low-voltage coagulation mode of an HF generator, as used for bipolar pincettes.
High-frequency (HF, also “radio frequency,” RF) is understood in the context of the present disclosure to mean a frequency range from 100 kHz to 50 MHz, in particular between 300 kHz and 4 MHz.
In embodiments, the supply lines run inside the main body and emerge at the edge of the main body. This facilitates a very compact and smooth configuration of the HF applicator. The supply lines can therefore be cast, for example, into the main body in a mold casting process during the manufacturing of the main body.
In embodiments, the flat main body with the electrodes is designed to be flexibly bendable. As a result, it can be inserted into the nasal cavities of the patient very easily and with very low risk of injury and can adapt to the relief of the surface to be characterized and also inserted into curved gaps of the nasal passages between the nasal conchae. Flexible electrodes can be designed, for example, as conductive, for example metallic, foils.
Suitable materials for the main body are, for example, plastics, ceramics, or silicones, the temperature stability of which is sufficient for the temperatures occurring during HF surgical procedures. Typical temperatures are approximately 80° C., so that a temperature stability of approx. 100° C. or above is favorable. Silicones, as well as soft plastics, are particularly suitable for flexible HF applicators due to their softness while ceramics and harder plastics can be used for more rigid HF applicators. The main bodies of the HF applicators are produced using methods, for example injection molding, that are proven and known for the respective materials.
In embodiments, the two electrodes are circular, annular, or elliptical, wherein one of the two electrodes is arranged as an inner electrode, in particular concentrically, inside the other electrode, wherein in particular both the outer electrode and the inner electrode are annular. The HF field between the two electrodes is then also annular and has an extent that prevents too strong of a localization and dehydration of the treated tissue.
In alternative embodiments, the two electrodes are arranged next to each other on the side face of the main body, in particular basically semicircularly with an insulating strip between the electrodes. This arrangement also effects a flat, less localized distribution of the HF field and an accordingly less pronounced dehydration of the treated tissue.
In other embodiments, both side faces of the main body each have electrode surfaces of both electrodes, so that one bipolar electrode arrangement results on each of the two side faces of the main body. In this manner, nerve tissue can be cauterized on both sides of a nasal passage and the treatment time can be shortened.
In one embodiment with a two-sided application, the main body is completely penetrated by the two electrodes, wherein the electrodes are each designed to penetrate the entire main body as a solid piece. This simplifies the contact and represents a robust type of an HF applicator.
Alternatively, in embodiments, the electrodes are each set into recesses in the side face or the side faces of the main body, wherein the electrode faces terminate in particular flush with the side face or the side faces of the main body.
A development of the HF applicator provides that the main body comprises a canal structure for a fluid cooling medium, which can be introduced into the main body from outside and discharged again. Such a cooling of the HF applicator serves to cool the mucous membrane against which the HF applicator lies during the procedure. The supplied HF energy heats the upper tissue layers consisting of mucous membrane and nerve tissue. Through the cooling, however, so much heat energy is in turn drawn out of the mucous membrane that the temperature in the mucous membrane does not exceed a harmful amount. The cooling effect, however, does not go so far into the nerve tissue that a cauterization or sclerosing is prevented there. Overall, treatment with a cooled version of the HF applicator according to the present disclosure is very gentle and efficient. The risk of subsequent adverse events is further prevented.
The object underlying the present disclosure is based is also solved by an HF application system with at least one surgical HF instrument, which is equipped with a previously described bipolar HF applicator according to the present disclosure, and an HF generator, which is designed to supply the HF applicator with HF energy.
The HF application system embodies the same features, advantages, and characteristics as the bipolar HF applicator according to the present disclosure in its various embodiments.
In embodiments, the system may also include a cooling device and a cooling circuit. The cooling device can be capable of cooling a fluid cooling medium in order to cool the HF applicator. The cooling circuit can be designed to introduce the fluid cooling medium into a channel structure of the flat main body of the HF applicator for cooling the HF applicator. The cooling circuit can also receive the cooling medium that is discharged from the channel structure of the HF applicator. This achieves gentle and efficient treatment with further reduced risk of unwanted injuries. Another method for the cooling is the use of one or more Peltier elements, the hot side of which is cooled via the cooling circuit.
Further features of the present disclosure will become evident from the description of embodiments according to the present disclosure, together with the claims and the appended drawings. Embodiments according to the present disclosure can fulfill individual features or a combination of several features.
Within the context of the disclosed features which are labeled with “in particular” or “preferably” are to be understood to be optional features.
The present disclosure is described below, without restricting the general idea of the disclosure, based on exemplary embodiments in reference to the drawings, whereby we expressly refer to the drawings with regard to the disclosure of all details according to the present disclosure that are not explained in greater detail in the text. In the drawings:
In the drawings, the same or similar elements and/or parts are, in each case, provided with the same reference numerals such that a repeated presentation is dispensed with in each case.
In the lower part of
As shown in the upper and lower parts on the left half of
In the right half of
Instead of a pure fluid cooling, a cooling element with one or more Peltier elements can also be used, the warm side of which must in turn be cooled. An advantage of this measure is a faster response of the cooling when it is required. It must be ensured in this case that the rear side does not become too hot, since the waste heat may only be transported away with a delay.
A section through the nasal cavity 6 of a human skull 1 is shown in
The HF applicator 10 on the distal tip of an HF instrument 11 is inserted into the nasal cavity 6. The positioning of the HF instrument 11 is to be taken schematically, since the insertion takes place through the nostril (apertura nasi) and not through the nasal tissue. The HF applicator 10 is located in the nasal passage between the middle nasal concha 9a and the inferior nasal concha 9b. In this position, the lower nerve branch 8b should be ablated or temporarily or permanently hindered in its function in order to treat refractory rhinitis.
The applicator 10 is placed on the nervus/ramus nasalis posteriores 8b on the inferior nasal concha 9b as shown on the right in
In the third exemplary embodiment in
The fourth exemplary embodiment of an HF applicator 31 of
It is advantageous if the positioning of the channel guarantees uniform heat dissipation from both electrodes of the HF applicator 10. In the electrodes 12, 14 of the HF applicators 30, 31, and 32 of
This branched channel structure 24 ensures an even stronger discharge of heat energy than the unbranched channel structure 20, because the heat has a short path to the nearest channel at every point in the main body 16.
The concentric channels are particularly efficient when, in the case of a concentric electrode arrangement like those of
All of the indicated features, including those which are to be inferred from the drawings alone, as well as individual features which are disclosed in combination with other features, are deemed to be essential to the present disclosure both alone and in combination. Embodiments according to the present disclosure can be fulfilled by individual features or a combination of several features.
1 Skull
2 Bone layer
3 Nerve tissue layer
4 Mucous membrane
5 Nerve
6 Nasal cavity
7 Coagulation region
8
a Rr. nasales posteriores superiores laterales
8
b Rr. nasales posteriors inferiors
9
a Concha nasalis media
9
b Concha nasalis inferior
10 HF applicator
11 Surgical HF instrument
12 Electrode
14 Electrode
16 Main body
18 HF field
20 Channel structure for fluid coolant
20′ Inner channel for fluid coolant
21 Supply line for fluid coolant
23 Discharge line for fluid coolant
24 Branched channel structure for fluid coolant
30 HF applicator
31 HF applicator
32 HF applicator
Number | Date | Country | Kind |
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10 2021 103 506.6 | Feb 2021 | DE | national |