MEDICAL INSTRUMENT FOR INTRODUCING A FLUID THERAPEUTIC SUBSTANCE INTO A BODY CAVE

DE502023003917D1Active Publication Date: 2026-05-21CAPNOPHARM GMBH
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Patent Information

Authority / Receiving Office
DE · DE
Patent Type
Patents
Current Assignee / Owner
CAPNOPHARM GMBH
Filing Date
2023-02-24
Publication Date
2026-05-21
Patent Text Reader
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Description

Technical field

[0001] The invention relates to a medical instrument for introducing a fluid-like therapeutic substance into a cavity of a body. The medical instrument comprises a nozzle with a nozzle head for atomizing the fluid-like therapeutic substance to be introduced. Furthermore, the medical instrument has a shaft that is at least substantially elongated and at least substantially rigid, with the nozzle head arranged at one end of this shaft. The medical instrument also further comprises a flexible tube that is arranged within the elongated shaft and is fluidically connected to the nozzle head. State of the art

[0002] Medical instruments for introducing a fluid-like therapeutic substance into a cavity of a body are known in the prior art. For example, such instruments are known from DE 10 2012 104 629 A1 or from WO 2020 / 048627 A1, which have a shaft at one end of which a nozzle is arranged, with which the fluid-like therapeutic substance can be sprayed into a cavity of a body.

[0003] EP 1 433 493 A2 relates to nebulization catheters, in particular for introducing a medication nebulized into an aerosol with a gas into the lungs. WO 92 / 19383 A1 discloses the use of an impactor for atomization in inhalation devices to achieve a finer droplet size. DE 10 2016 202316 A1 teaches the generation of submicron particles with an aerosol generator and their introduction into a body cavity in a carrier gas stream. Atomization using an impact pin is known from DE 10 2007 014100 A1 for other industries, such as seawater desalination or gold mining, where a subsequent process step separates components of a gas mixture. From JP 2001 104489 A a nebulizer with a liquid reflector for an endoscope is known, which is designed to distribute a liquid evenly on an intestinal wall.

[0004] However, the design of existing instruments is relatively complex. Furthermore, the fluid-based therapeutic substance cannot be optimally distributed within the body cavity using these instruments. In addition, these technologies usually require a gas flow, which complicates application in a closed body cavity: to prevent a pressure increase within the cavity, an inlet and outlet must be created, making it difficult to determine the proportion of the therapeutic solution that remains within the body cavity or merely passes through it. Moreover, it is not possible to verify the continuity of the nebulization system. Thus, with a continuous gas flow, the leakage of a toxic substance (such as cytotoxic drugs) cannot be ruled out.Another problem with current technology is the sometimes high dead volume in the delivery systems, which can result in 5% to 10% of the therapeutic substance not reaching the patient. There is also room for improvement here. Description of the invention

[0005] The invention is based on the objective of providing a medical instrument for introducing a fluid-like therapeutic substance into a body cavity, which eliminates the aforementioned problems and disadvantages of the prior art. In particular, it is an objective of the present invention to provide a medical instrument that has a particularly simple design and offers particularly good distribution of the therapeutic substance within the body cavity.

[0006] This problem is solved by the subject matter of independent claim 1. Further possible embodiments of the invention are specified in particular in the dependent claims.

[0007] The solution according to the invention consists in particular of providing a medical instrument for introducing a fluid-shaped therapeutic substance into a cavity of a body, comprising: a nozzle with a nozzle head for atomizing the fluid-shaped therapeutic substance to be introduced without the addition of gas; a shaft that is at least substantially elongated and at least substantially rigid, at one end of which the nozzle head is arranged; and a flexible tube that is arranged inside the elongated shaft and is fluidically connected to the nozzle head, wherein the nozzle has an impact device comprising an impact element that is arranged in front of a nozzle opening of the nozzle head at least substantially coaxially to the nozzle opening, wherein the nozzle opening has a diameter in the range of 0.01 mm to 0.5 mm, and wherein at least part of the impact device is formed integrally with the nozzle head.

[0008] The term "body cavity" encompasses both intrinsic cavities, such as the natural cavity of a hollow organ or a body cavity like the abdominal or pleural cavity, and surgically created cavities, such as a pseudopneumoperitoneum. Hollow organs like the esophagus, stomach, bladder, or other organs containing a virtual space lined with epithelium can frequently serve as cancerous foci. The abdominal cavity and pleural cavities are particularly important regions of the body with regard to cancerous foci. The abdominal cavity extends from the thorax at the diaphragm to the pelvis at the pelvic margin. It contains numerous organs, including the stomach, small and large intestines, liver, gallbladder, and pancreas. The abdominal cavity and pleural cavities are lined by an extensive membrane called the peritoneum and pleural cavity, respectively.The pleura is the membrane that covers the abdominal and pelvic walls (parietal peritoneum) and the organs within them (visceral peritoneum), as well as the inner surface of the thoracic cavity (parietal pleura) and the organs within it (visceral pleura). Cancer can spread within these areas, meaning that the tissue or part of the tissue containing cancer cells can be located there.

[0009] The fluid-based therapeutic substance is a fluid, in particular a pharmaceutical, that is introduced into the body cavity of the patient as part of a therapeutic procedure or treatment. The fluid, preferably the pharmaceutical, is liquid and not gaseous. According to the invention, only the fluid-based (liquid) therapeutic substance is atomized, without the addition of gas. That is, only an atomized liquid and no gas emerges from the nozzle. The fluid-based therapeutic substance preferably serves to treat the cancerous site. Preferably, the fluid-based therapeutic substance is or comprises one or more chemotherapeutic agents.Preferably, the one, two, several or all of the chemotherapeutic agents used in the present invention are selected from the group consisting of chemotherapeutic agents used against a type of cancer selected from the group comprising: gastrointestinal cancer, in particular gastric cancer, colon cancer, liver or pancreatic cancer, appendix cancer, esophageal cancer, hepatocellular carcinoma, gynecological cancer; in particular primary peritoneal cancer, ovarian cancer, endometrial cancer; prostate cancer, leukemia, lymphoma, soft tissue sarcoma, multiple myeloma, bladder cancer, lung cancer, thyroid cancer, Kaposi's sarcoma and tumors of embryonic origin.

[0010] The volume of the active substance(s), preferably a chemotherapeutic agent, but also DNA, RNA, nanoparticles, immunotherapeutic agents and viruses, is preferably contained in a volume of 5 ml to 2500 ml, preferably 10 ml to 1000 ml, more preferably 20 ml to 500 ml, more preferably 30 to 300 ml of fluid-like therapeutic substance, wherein this specification preferably refers to the total amount administered during an application, preferably dissolved or suspended or redispersed in hydrophilic or lipophilic solutions and emulsions.

[0011] Preferably, treatment is directed at a type of cancer selected from the group comprising: gastrointestinal cancer, in particular gastric cancer, colorectal cancer, hepatobiliary or pancreatic cancer, appendiceal cancer, esophageal cancer, hepatocellular carcinoma, or gynecological cancer; in particular primary peritoneal cancer, ovarian cancer, endometrial cancer, and tumors of embryonic origin. The treatment described herein may aim to reduce tumor size and the number of tumor foci. Tumor foci include both the primary tumor and metastases and other tumor proliferations. The treatment may also aim to prevent or delay the recurrence of cancer after tumor removal or partial tumor removal, preferably after surgical tumor resection.

[0012] It is preferred that the treatment be repeated, with two, three or more administrations of the therapeutic substance aerosolized by the delivery system.

[0013] In the medical instrument or delivery system, the end of the tube is connected directly to the nozzle. The other end of the tube is fluidically connectable to, or connected to, a fluid source for supplying the fluid-like therapeutic substance. The tube extends through the shaft to the end of the shaft where the nozzle is located. This allows the "dead volume" of the therapeutic substance in the delivery system to be reduced to zero. Preferably, the tube is connected directly to the fluid source. However, the tube can also be connected to the nozzle indirectly, particularly via an interposed connecting element. For example, it is also conceivable that the shaft itself forms a cavity connected on one side to an outlet of the tube and on the other side to an inlet of the nozzle, so that the shaft itself is part of the fluid-passing connection.In this case, however, the "dead volume" of the therapeutic substance, which does not reach the patient, may be increased.

[0014] In the delivery system, an impact device can preferably be arranged on the nozzle head. At least part of the impact device is integrally formed with the nozzle head. The fact that the impact element is positioned in front of the nozzle opening of the nozzle head means that the impact element is directed away from the shaft. The impact element is thus arranged so that the substance flowing from the nozzle opening strikes the impact element and is better distributed by means of it.

[0015] On the one hand, the impactor ensures a particularly wide atomization angle. For example, an atomization angle greater than 120°, and especially greater than 150°, can be achieved.

[0016] On the other hand, the impactor does not alter the particularly small droplet size. For example, a median aerodynamic droplet size (MAD - median aerodynamic diameter) of less than 35 µm, and particularly less than 30 µm, can be achieved. This droplet size hardly changes between water (distilled water), sugar-containing solutions (such as 5% glucose solution), and oily solutions (such as silicone oil 5). The viscosity of the fluid-like therapeutic substance is preferably in the range of 1 to 100 mPas, more preferably 1 to 30 mPas.

[0017] Overall, thanks to the impact device, the therapeutic substance is distributed particularly well in the cavity, while simultaneously ensuring a simple design of the medical instrument and without impairing the function of the cone nozzle.

[0018] According to an advantageous embodiment of the invention, the impact body has a parabolic, triangular, trapezoidal, or stepped pyramidal shape in longitudinal section. The longitudinal section is a section along a plane containing an axis of rotation of the instrument that extends through the nozzle opening. The parabolic and stepped pyramidal shapes are particularly suitable for distributing the substance effectively. Advantageously, the impact body is rotationally symmetrical, preferably about an axis coaxial with the nozzle opening. In this case, a parabolic shape results in an ellipsoidal body, a triangular shape in a cone, and a stepped pyramidal shape in a stepped cone, wherein the steps can be cylindrical or also conical or frustoconical.

[0019] An advantageous embodiment of the invention provides that the impact device has a holding device on which the impact element is arranged. The holding device thus allows the impact element to be easily positioned correctly on the nozzle. The holding device is preferably at least substantially rod-shaped and thin, and furthermore preferably bent by 90° or 180°. Due to its rod-shaped design, the holding device only minimally impedes the distribution of the substance. The holding device can also comprise more than one arm, allowing the individual arms to be thinner. In a further advantageous embodiment of the invention, the holding device is bent in an L-shape or a U-shape, with the impact element arranged at a first end of the holding device, and with the second end of the holding device being radially attached to the outside of the nozzle head and / or the shaft.

[0020] In particular, the holding device is designed as an L-shaped bent rod, the diameter of which is preferably a maximum of 1 / 5 of the diameter of the nozzle head. This ensures that the holding device obstructs the distribution of the substance very little. If several rods are provided, the sum of the diameters of the two or more rods is preferably a maximum of 1 / 5 of the diameter of the nozzle head, more preferably a maximum of 1 / 7, and further preferably a maximum of 1 / 10.

[0021] Regardless of this, the holding device can be designed to taper to a point towards the nozzle opening. In particular, the holding device can have tapered deflecting surfaces, whereby the deflecting surfaces of the holding device deflect the substance, resulting in less adhesion of the substance to the holding device.

[0022] An advantageous further development of the invention provides that a charging device for electrostatically charging the fluid-shaped therapeutic substance is arranged on the holding device.

[0023] Electrostatic charging of the fluid-shaped therapeutic substance can improve the adhesion and / or penetration depth of particles of the substance to or into tissue in the cavity.

[0024] In an advantageous embodiment of the invention, the charging device is arranged on the opposite side to the impact body on the holding device.

[0025] In particular, a charging area of ​​the charging device, designed for electrostatic charging, is arranged on the opposite side of the impact body on the holding device. Thus, the charging device or its charging area is not located in the direct spray field of the nozzle. This prevents the charging device or its charging area from being covered by the substance or deposits. The charging device or its charging area can generally be designed as a brush or made of solid material. In a brush-like design, the charging area is formed with several electrical wires. In a solid material design, the charging area is uniformly shaped. Particularly in the case of a uniform design, the charging area can preferably be flush with the holding device.

[0026] According to an advantageous embodiment of the invention, the charging device comprises a conductive film or is formed from a conductive film. Such a conductive film can be understood as a solid material forming the charging device or the charging area. The conductive film preferably extends from one end of the shaft, on which the nozzle is arranged, along the shaft to the other end of the shaft, which is located away from the nozzle. At the other end, the conductive film can be connected to, or is connected to, a power source, in particular a high-voltage source, by means of a terminal. At one end of the shaft, the conductive film extends from the shaft along the nozzle or along the nozzle head and the holding device of the impact device.

[0027] The conductive film makes it easy and safe to apply the charge to the substance at the charging area of ​​the charging device. Furthermore, the conductive film is extremely thin, so the maximum size of the instrument, for example, for use in a trocar, is not exceeded.

[0028] An advantageous further development of the invention provides that an area of ​​the conductor foil is exposed to form a charging area for electrostatic charging of the fluid-shaped therapeutic substance.

[0029] In other words, the charging area contains an exposed electrical conductor of the conductive film, designed to electrostatically charge the fluid-like therapeutic substance. The exposed area is thus configured to transfer an electrostatic charge to the therapeutic substance or particles thereof, particularly during treatment. For example, an insulating layer of the conductive film can be removed from the charging area, exposing the electrical conductor for contact with the substance.

[0030] In an advantageous embodiment of the invention, the nozzle head has a push-fit connector at one end opposite the nozzle opening, with the hose being directly attached to the connector. Since the hose is directly connected to the nozzle head or its connector, a simple instrument is achieved in which only a single connection point is required to deliver the therapeutic substance to the nozzle head. This minimizes the number of connections and thus the resulting weak points, such as leakage or pressure loss. Furthermore, the substance only comes into contact with the nozzle and the hose, thus reducing contamination. In addition, the push-fit connector can be sealed without complex sealants. A simple seal is achieved, in particular, when the hose is press-fitted onto the connector.The tubing is therefore preferably flexible enough to expand radially when pushed onto the connector. To facilitate insertion, the connector may preferably have a chamfer on its outer circumference facing the tubing. Furthermore, this makes it easier to provide different versions of the medical instrument adapted for specific substances.

[0031] The nozzle head can be formed as a single piece with the push-fit connector. In this case, it also has a continuous, preferably straight, bore for conveying the fluid-like therapeutic substance. Alternatively, the nozzle head could be multi-piece, for example, two-piece. This would allow for the easy integration of additional functional elements into the nozzle. In a two-piece version, where the push-fit connector and the rest of the nozzle head are separate parts, the push-fit connector can preferably be pressed into the nozzle head. Particularly preferably, the push-fit connector and / or the nozzle head has several radially circumferential sealing ribs. This eliminates the need for additional sealing.

[0032] According to an advantageous embodiment of the invention, the medical instrument has a clamping sleeve arranged on the tubing such that the clamping sleeve presses the end of the tubing, which is attached to the connector, against the outer surface of the connector with its inner surface. This ensures a tight seal between the tubing and the connector. The clamping sleeve exerts external counter-pressure on the attached end of the tubing, so that the end of the tubing sits tightly on the connector.

[0033] An advantageous embodiment of the invention provides that the shaft has a preferably circumferential stop area against which the clamping sleeve abuts. This stop area enables precise positioning of the clamping sleeve, particularly its axial position (as viewed along the axis of rotation). Simultaneously, the stop area prevents the clamping sleeve from shifting, especially axially.

[0034] Preferably, the nozzle also has a corresponding additional stop area. Then, in the assembled state of the instrument, the clamping sleeve is arranged, in particular axially, between the stop area of ​​the shaft and the additional stop area of ​​the nozzle.

[0035] In other embodiments, the hose is inserted into the nozzle head. For this purpose, the nozzle head can have a hose receiving opening into which the hose can be inserted. Alternatively, the hose can be connected to the nozzle head using suitable welding processes. Screw connections and adhesive bonds can be avoided, thereby improving safety and simplifying manufacturing.

[0036] In a further advantageous embodiment of the invention, the medical instrument includes a filter or particle filter, which is preferably arranged in the nozzle. The filter or particle filter can be a component referred to above as a functional element. Accordingly, the nozzle can then, in particular, have a two-part design. The particle filter can, for example, be a polypropylene or metal filter. The filter is arranged, in particular, for cleaning the fluid-shaped therapeutic substance of impurities. Alternatively, it would also be conceivable that the filter is arranged in the tubing, preferably at the end of the tubing facing the nozzle head. However, it can also be arranged at the inlet end of the tubing or be an integral part of the tubing.

[0037] According to an advantageous embodiment of the invention, a bore in the shaft is designed as a clearance fit to an outer diameter of the hose such that the hose is movably, and in particular rotatably, arranged within the shaft. This improves the handling of the medical instrument, as the hose can rotate with it.

[0038] In a further advantageous embodiment of the invention, the medical instrument also features an adjustable external stop for positioning within a trocar and a handle, both arranged on the shaft. The external stop ensures correct positioning within the trocar. The handle improves the handling of the medical instrument. Preferably, a drainage port, for example, for connecting to a tube, can be integrated into the external stop. This drainage port serves, for example, to safely remove toxic aerosols after surgery.

[0039] According to an advantageous embodiment of the invention, the nozzle has a machine-readable identifier containing information about the type of nozzle. This information may, for example, include details about the substances that can be used with the nozzle. Thus, different nozzles, which differ from other nozzles, for example, in the size of the nozzle opening or the design of the impact device, may be suitable for use with different substances. The machine-readable identifier may, in particular, be a chip or a barcode.

[0040] For example, the nozzle head can be interchangeably arranged on the shaft and, in particular, can be detachably attached to the shaft by means of a thread and / or a locking device, preferably using a special tool. This allows several nozzles to be used with one instrument. This also results in a system for introducing a therapeutic substance into a cavity of a body, wherein the system comprises: one of the medical instruments described above; and another nozzle with another nozzle head and another impact device with another impact body, wherein the further nozzle head has another nozzle opening, and wherein the further nozzle can be attached to the shaft in place of the nozzle, and wherein the nozzle opening of the nozzle head differs from the further nozzle opening of the further nozzle head and / or the impact body of the nozzle head differs from the further impact body.

[0041] Even though the nozzle head has been described in advance as replaceable and detachable from the shaft without damage, in a further preferred embodiment the nozzle head can be permanently and, in particular, not non-destructively connected to the shaft. For example, the nozzle head can be pressed into the shaft. For this purpose, the shaft and / or the nozzle head can preferably have several radially circumferential sealing ribs that are deformed accordingly during pressing.

[0042] The medical instruments described above according to the invention provide, as a whole, a simple yet safe tool for minimally invasive surgery and the administration of therapeutic aerosols into body cavities. The instrument according to the invention is also provided in a system for introducing fluid-like therapeutic substances into cavities. The system preferably comprises a trocar, preferably a source for the therapeutic substance, preferably a fluid pump, and one of the instruments described above according to the invention, which is fluidically connected or connectable to the fluid source and the fluid pump, in particular by means of the tubing, and can be inserted into the cavity by means of the trocar.

[0043] In a second aspect, the invention solves the aforementioned problem by means of a system comprising a trocar and a medical instrument according to one of the preferred embodiments of a medical instrument described above in accordance with the first aspect, wherein the medical instrument extends through the trocar.

[0044] In a third aspect (which is not claimed), the present disclosure solves the problem in a therapeutic method for treating tumor tissue in a hollow organ by the steps of: providing a trocar with a medical instrument contained therein according to one of the preferred embodiments of a medical instrument described above, as described in the first aspect of the invention; supplying a fluid-shaped therapeutic substance to the medical instrument; and atomizing the fluid-shaped therapeutic substance by means of the nozzle with an atomization angle greater than 120°. The atomization angle is preferably greater than 150°, more preferably greater than 170°, 180°, 200°, 240°, or 270°.

[0045] Preferably, only the fluid-form therapeutic substance is supplied to the medical instrument. This means that, in particular, no gas and / or propellant and / or carrier fluid is added to the medical instrument.

[0046] Preferably, the fluid-based therapeutic substance is supplied at a pressure in the range of 10 bar to 25 bar, preferably 11 bar to 20 bar (measured upstream of the nozzle). This advantageously influences the nebulization of the fluid-based substance.

[0047] In a further aspect (which is not claimed), the present disclosure solves the aforementioned problem by using a medical instrument according to one of the preferred embodiments of a medical instrument described above according to the first aspect of the invention for treating tumor tissue in a hollow organ. Brief description of the drawings

[0048] The various and exemplary features described above can be combined with one another according to the invention, insofar as this is technically sensible and suitable. Further features, advantages, and embodiments of the invention will become apparent from the following description of exemplary embodiments and with reference to the figures. The figures show: Fig. 1 a schematic perspective representation of an exemplary medical instrument according to the present invention; Fig. 2 a sectional view of the in Fig. 1 medical instrument shown; Fig. 3 a schematic enlarged representation of a front area of ​​the in Fig. 1 and Fig. 2 medical instrument shown; Fig. 4 a sectional view of the in Fig. 3 shown enlarged area of ​​the medical instrument; and Fig. 5 a schematic application of a medical instrument according to the present invention. Ways to implement the invention

[0049] Fig. 1 Figure 1 shows a schematic perspective view of an exemplary medical instrument 100 according to the present invention. Fig. 2 is a sectional view of the in Fig. 1 100 medical instruments shown.

[0050] As in the Fig. 1 and the Fig. 2 As can be seen, the medical instrument 100 has an elongated shaft 120. At one end of the shaft 120, a nozzle 110 with an impact device 130 is formed. For clarity, the medical instrument 100 is shown in several sections to allow all aspects to be seen at a glance, despite its length. A handle 190 and an external stop 180 are arranged on the shaft 120. The external stop 180 serves as a stop for a trocar 200 (not shown).

[0051] In Fig. 2It can be seen that the outer stop 180 can perform an additional function by means of a discharge area 181. Thus, the outer stop 180 can also serve to discharge a fluid, for example insufflation gas, via the discharge area 181.

[0052] As also in Fig. 2 As can be seen, a tube 140 runs inside the shaft 120 up to the nozzle 110. The tube 140 extends out of the shaft 120 at the end opposite the nozzle 110 and can preferably be led to a source 400 of the therapeutic substance (not shown).

[0053] The charging device 150 has a conductive foil 151. The conductive foil 151 extends along the shaft 120 to the end opposite the nozzle 110. In particular, the conductive foil 151 extends externally along the shaft 120 to the opposite end. At this opposite end, for example, a terminal 153 can be provided to connect the charging device 150 to an energy source 300 (not shown) for providing the energy required for electrostatic charging.

[0054] In the Fig. 3 is a schematic enlarged representation of a front area of ​​the in the Figs. 1 and 2 The medical instrument shown is 100. Fig. 4 shows a cross-sectional view of the in Fig. 3 shown enlarged area of ​​the medical instrument 100.

[0055] The nozzle 110 has a nozzle head 111. The nozzle head 111 is located at one end 121 of the shaft 120. Here, the nozzle head 111 is formed in two parts with a push-fit connector 113. Alternatively, a nozzle head 111 formed in one piece with a push-fit connector 113 would also be possible. The push-fit connector 113 serves to connect to the hose 140, in particular to one end 141 of the hose 140. For this purpose, the end 141 is pushed onto the push-fit connector 113. To simplify the pushing-on process, the push-fit connector 113 has a chamfer 114. When pushed on, the hose 140, or rather its end 141, expands radially.

[0056] Furthermore, the nozzle head 111 has a nozzle opening 112. The nozzle opening 112 is located at the end of the nozzle head 111 opposite the plug connector 113. The impact device 130 is also located at this opposite end. The impact device 130 has an impact body 131, which serves to better distribute the substance. The impact body 131 is arranged coaxially with the nozzle opening 112, so that the fluid-like substance flowing from the nozzle opening 112 strikes the impact body 131. Here, the impact body 131 is designed in a stepped pyramidal shape. Alternatively, it could, for example, also be parabolic.

[0057] The nozzle opening has a diameter in the range of 0.01 mm to 0.5 mm, preferably 0.02 mm to 0.4 mm, more preferably 0.05 mm to 0.3 mm.

[0058] The impact device 130 has a holding device 132 for positioning the impact body 131 in the correct position, i.e., coaxially with the nozzle opening 112. The holding device 132 has a first end 133 at which the impact body 131 is arranged, and a second end 134 at which the holding device 132 is connected to the nozzle head 111.

[0059] For example, as in the Fig. 4 It can be seen that the holding device 132 is formed integrally with the nozzle head 111. The holding device 132 generally extends axially forward from the nozzle head 111 (in the Fig. 4 to the right) and then inwards to a rotation axis R of the medical instrument 100, which also passes through the nozzle opening 112. As in the Fig. 3To detect, the holding device 132 can have one or more deflection surfaces 135 to deflect the substance and thus reduce the deposition of the substance on the holding device 132.

[0060] Overall, the holding device 132 can be used as in the Figs. 3 and 4 The holding device 132 is shown to be at least essentially L-shaped. Alternatively, it can also be U-shaped.

[0061] A part of the charging device 150 is also arranged on the nozzle 110 or on the nozzle head 111. In particular, a charging area 152 of the charging device 150 is arranged on the holding device 132. The charging area 152 is, for example, as shown in the Fig. 3As indicated, an exposed area of ​​the conductor foil 151 extends to the first end 133 of the holding device 132. The charging area 152 is specifically located on a side of the holding device 132 opposite the impact body 131. Thus, the charging area 152 is also located on a side of the holding device 132 facing away from the nozzle opening 112. This has the advantage that fewer particles of the fluid substance, which could impede the function of the charging device 150, accumulate on the charging area 152.

[0062] A particle filter 170 is also arranged inside the nozzle 110. The particle filter 170 is located, in particular, between the plug connector 113 and the rest of the nozzle head 111.

[0063] Furthermore, the medical instrument 100 has a clamping sleeve 160 designed to press the tube 140, or its end 141, onto the connector 113. Specifically, an inner surface 161 of the clamping sleeve 160 presses the tube 140 onto an outer surface 115 of the connector 113. In the axial direction, the clamping sleeve 160 is positioned between a stop area 122 of the shaft 120 and another stop area 117 of the nozzle 110. This prevents the clamping sleeve 160 from slipping.

[0064] As in the Fig. 4 It is clearly visible that there is a gap between the hose 140 and the shaft 120, so that the hose 140 does not become jammed inside the shaft 120. For this purpose, a bore 123 in the shaft 120 is larger than the outer diameter 142 of the hose 140.

[0065] The medical instrument 100 may have an identifier 116. The identifier 116 may, in particular, be a machine-readable identifier containing information about the type of nozzle 110.

[0066] Fig. 5 Figure 1 shows the schematic application of the medical instrument 100 according to the present invention. The medical instrument 100 is designed for introducing a fluid-like therapeutic substance into a cavity 510 of a body 500. For this purpose, the medical instrument 100 can be positioned within the cavity 510 by means of a trocar 200. The medical instrument 100 is, as shown in the Fig. 5As indicated, the medical instrument 100 is connected to a source 400 that provides the fluid-shaped therapeutic substance. Furthermore, the medical instrument 100 is connected to a power source 300 for providing energy to the charging device 150. The power source is preferably configured to provide a voltage in the range of 4 kV to 9 kV, preferably 6 kV to 7 kV, and the charging device 150 is configured to receive such a voltage.

[0067] It should be noted that the features of the invention described with reference to individual embodiments or variants, such as the type and design of the individual components as well as their precise dimensions and spatial arrangement, may also be present in other embodiments. Furthermore, not all features of such combined features of individual embodiments need necessarily be implemented in a given embodiment.

Claims

1. Medical instrument (100) for introducing a fluid therapeutic substance into a cavity (510) of a body (500), wherein the medical instrument (100) comprises: a nozzle (110) with a nozzle head (111) for atomizing the fluid therapeutic substance to be introduced without adding gas; an at least substantially elongated and at least substantially rigid shaft (120), at one end (121) of which the nozzle head (111) is arranged; and a flexible tube (140) arranged inside the elongated shaft (120) and fluidically connected to the nozzle head (111), characterized in that the nozzle (110) has an impact device (130) comprising an impact body (131) arranged in front of a nozzle opening (112) of the nozzle head (111) at least substantially coaxially with the nozzle opening (112), wherein the nozzle opening (112) has a diameter in a range from 0.01 mm to 0.5 mm, and wherein at least a portion of the impact device (130) is formed integrally with the nozzle head (111).

2. Medical instrument (100) according to claim 1, wherein the impact body (131) has a parabolic shape, triangular shape, trapezoidal shape, or pyramidal shape, preferably a stepped pyramidal shape, in longitudinal section.

3. Medical instrument (100) according to one of claims 1 or 2, wherein the impact device (130) has a holding device (132) on which the impact body (131) is arranged, wherein the holding device (132) is preferably L-shaped or U-shaped, wherein the impact body (131) is arranged at a first end (133) of the holding device (132), wherein the second end (134) of the holding device (132) is attached to the nozzle head (111) and / or the shaft (120).

4. Medical instrument (100) according to claim 3, wherein a charging device (150) for electrostatically charging the fluid therapeutic substance is arranged on the holding device (132).

5. Medical instrument (100) according to claim 4, wherein the charging device (150) is arranged on a side opposite to the impact body (131) on the holding device (132).

6. Medical instrument (100) according to claim 4 or 5, wherein the charging device (150) comprises a conductive foil (151).

7. Medical instrument (100) according to claim 6, wherein a region of the conductive foil (151) is exposed to form a charging region (152) for electrostatically charging the fluid therapeutic substance.

8. Medical instrument (100) according to one of the preceding claims, wherein the nozzle head (111) has a plug connection (113) at an end opposite the nozzle opening (112), and wherein the tube (140) is plugged directly onto the plug connection (113).

9. Medical instrument (100) according to claim 8, wherein the medical instrument (100) has a clamping sleeve (160) arranged on the tube (140) in such a way that the clamping sleeve (160) engages circumferentially with its inner surface (161) against an outer surface (115) of the plug connection (113) on an end (141) of the tube (140) that is plugged onto the plug connection (113) with its inner surface (161) against an outer surface (115) of the plug connection (113).

10. Medical instrument (100) according to claim 9, wherein the shaft (120) has a preferably circumferential stop area (122) against which the clamping sleeve (160) abuts.

11. Medical instrument (100) according to one of the preceding claims, wherein the medical instrument (100) has a particle filter (170) which is preferably arranged in the nozzle (110).

12. Medical instrument (100) according to one of the preceding claims, wherein a bore (123) in the shaft (120) is formed to an outer diameter (142) of the tube (140) as a clearance fit such that the tube (140) is movable, in particular rotatable, within the shaft (120).

13. Medical instrument (100) according to one of the preceding claims, wherein the medical instrument (100) further comprises an adjustable outer stop (180) for positioning in a trocar (200) and a handle (190) arranged on the shaft (120).

14. Medical instrument (100) according to any of the preceding claims, wherein the nozzle (110) has a machine-readable identifier (116) containing information about the type of nozzle (110).

15. System comprising a trocar (200) and a medical instrument (100) according to claim 13, wherein the medical instrument (100) extends through the trocar (200).