DE102013109896A1 - Therapy device for the administration of aerosol - Google Patents

Abstract

The invention comprises a device (1) suitable for insertion and use within a body cavity (2), in particular a hollow organ (26, 27, 37) of a patient, the device comprising: - a first expandable fluid chamber (3) for sealing a first one Section (6 ') of the body cavity (2), - an aerosol generating device (5) for producing a therapeutic aerosol in a treatment section (13) of the body cavity extending beyond the first section (5), - an insufflation device (6) for insufflating a gaseous one Medium (CO2, O2) in the treatment section (13) of the body cavity (2).

Description

The invention relates to a device of medical technology and more particularly to a device by which a method for the local killing of tumors in body cavities can be applied. Within the meaning of the invention, body cavities are also organs, in particular hollow organs of humans and animals, in particular organs such as esophagus, stomach, intestine, trachea, uterus, urethra, urinary bladder and fallopian tube.

From the WO 2012/163346 A1 An apparatus for delivering a substance in a body cavity is already known. The substance may, for example, be cytostatic agents such as doxorubicin, cisplatin or other chemotherapeutic agents. In particular, according to the WO 2012/163346 A1 provided that the substance conveyed under high pressure is nebulized into an aerosol at a needle nozzle. The aerosol mist obtained can be applied to the entire surface of the body cavity, which can be reached by the mist, and the substance develops its beneficial effect there.

An object of the invention is to propose an alternative device by means of which a substance can be localized and applied highly efficiently within a body cavity. In particular, it is an object of the invention to utilize the naturally existing accesses of organs, in particular of hollow organs, for a locally definable aerosol application within the organs and to dispense with resecting procedures as far as possible.

The object can be achieved by a device according to claim 1. There is provided a device suitable for insertion and use within an organ, particularly a body cavity of a patient, the device comprising a first expandable fluid chamber for sealing a first portion of the body cavity, an aerosol generating device for generating a therapeutic aerosol within one after the first portion extending treatment section of the organ or the body cavity, proposed.

Furthermore, it may be desirable to limit the effect - and thus the often associated side effect - of the substance used on the and only those parts or sections of the body cavity to be treated, which actually need this effect. For example, it can be diagnosed in some cancers that the diseased cells to be observed do not or not yet affect the entire body cavity but instead a localized tumor or several closely spaced tumors are present. The local limitation of the effect is even more desirable the more effectively i. also more toxic is the selected substance. For this purpose, in a further embodiment of the invention, the device has a second expandable fluid chamber for sealing a second section of the body cavity, wherein the treatment section is provided as Mittelababschnitt between the first and the second section.

The fluid chamber can be, for example, an expandable balloon, a so-called cuff, or a sealable expandable tube made of an elastomer. The fluid chamber is after blowing a fluid, such as the ambient air, close to the respective wall of the body cavity or seals the body cavity and can under certain circumstances and depending on the choice of the first portion of the body cavity while also stretch to a small extent. To better develop the effect of the aerosol, the device includes an insufflation device for insufflating a gaseous medium into the treatment section of the body cavity. In particular, by means of the insufflation device, the treatment section of the body cavity can be widened with a corresponding pressure of the gaseous medium, so that any wrinkles of the body cavity wall become smooth. Preferably, CO ₂ can be used as the gaseous medium. In particular, can be used for the respiratory organs such as the trachea and lung as the gaseous medium O ₂ or a gas mixture. As favorable, an applied by the insufflation pressure of a few hundredths to a few tenths of a millibar has been found. Particularly favorable has been found when the pressure between 10 and 15 mbar in insufflation of hollow organs of the respiratory tract, in particular the trachea, or 12 to 15 mmHg, ie about 16 to 20 mbar in insufflating other hollow organs. The introduction and pressurization of the gaseous medium takes place before the generation of the aerosol.

After sealing by means of the fluid chamber and insufflation, the treatment section of the body cavity intended for therapeutic treatment can now be aerosolized. For this purpose, the aerosol device may for example be provided as a nozzle, in particular as a needle nozzle, which is connected via a supply line to a pump.

In a preferred embodiment, the first fluid chamber is at the same time also the only fluid chamber that has to be used. In particular, it is provided that this fluid chamber is provided in the case of using the device within the trachea already on a per se known endotracheal tube or the like. The known endotracheal tube can be about a slightly curved, about 25-30 cm long Include plastic tube whose outer diameter corresponds approximately to the small finger diameter of the patient. At the mouth end, the tube may have a connecting piece for a respirator or a respiratory bag. When using the aerosol, it should also be ensured in this case that no aerosol can escape into the ambient air. The opposite end of the tube may be bevelled. About one to two fingers across it, the fluid chamber in the form of a small balloon, a so-called cuff, be attached. This can be filled via a tube attached to the tube via a valve with air. As a result, gaps between the tube and trachea can be closed so that the trachea is sealed and the only way into the lungs via the tube leads. The aerosol generating device and in a further embodiment, the insufflation device can now also be passed through the above-mentioned tube. Furthermore, means may still be present on the device, which allows a positional fixation of the aerosol generating device, which may be designed as a nozzle. In one embodiment, a means for this may, for example, be another balloon which can also be filled with air via a tube which can be passed through the tube.

In a further embodiment of the invention, a device suitable for insertion and use in a tubular body cavity of a patient, such. In the esophagus, the device comprises a first expandable fluid chamber for sealing a first portion of the body cavity, a second expandable fluid chamber for sealing a second portion of the body cavity, an aerosol generating device for creating a therapeutic aerosol within it between the first and second portions extending central portion of the body cavity, proposed. The middle section is also the treatment section in this case. In this embodiment, means may also be provided for insufflating the body cavity. These means may comprise an insufflation device with a feed line approximately in the form of a hose which can be connected to a pressure pump, which conveys, for example, a gas or gas mixture from the group CO ₂ , O ₂ , helium.

Advantageously, the device can also have a monitoring device, in particular a camera, suitable for monitoring the treatment section of the body cavity. The camera may be provided with means allowing it to be rotated or otherwise displaced within the body cavity treatment section.

Advantageously, the device may also have a sensor device suitable for detecting the aerosol present in the treatment section. The sensor device may in particular be an IR diode arrangement which detects the tightness of the aerosol and converts it into electrical signals. The sensor device can also be provided with means which allow its rotation or other displacement within the body cavity treatment section.

Advantageously, the device may also have at least one surgical device suitable for manipulating the wall of the treatment section of the body cavity. The surgical device may be a cutting tool, such as a biopsy forceps to remove tissue or tools for non-surgical use, such as a pair of tweezers.

In one embodiment, a supply line of the aerosol generating device, in particular the pressure line with the selected substance or a mixture of different substances is passed through the first fluid chamber into the treatment section of the body cavity. The fluid chamber may be formed in this embodiment, for example, tubular, wherein the hose is designed at both ends with suitable means, such as gluing, relative to the supply line sealing. In particular, it has proven to be an advantage if the aerosol device is arranged as close as possible to the first fluid chamber and centrally to it and on the longitudinal central axis of the body cavity treatment section in order to be able to administer the aerosol mist even more uniformly in the volume of the treatment section.

In a further embodiment, it is provided to guide at least one further supply line through the first fluid chamber into the treatment section of the body cavity.

In particular, it is advantageous, as far as possible to guide all the supply lines used, including both fluid lines and electrical or mechanical connections to said objects and those still to be mentioned, through the first fluid chamber, in particular all supply lines within the tube formed by the fluid chamber to lead.

In a further embodiment of the invention, all supply lines within a receiving means, such as a jacket tube, can be guided to this end, to which the first fluid bag is sealingly connected.

Furthermore, as an embodiment of the invention, it is also proposed to provide an intubating device, wherein a supply line of the intubating device is guided through the first fluid chamber. Here For example, during a treatment of the trachea and / or the lungs, the ventilation of the patient can be easily maintained even during the drug aerosol therapy created with the device.

In a further embodiment, it is further proposed that the length of at least one fluid chamber can be changed by an adjusting means. Due to the length adjustment, the outer diameter of the fluid chamber can be better adapted to the inner cross section of the body cavity. The adjusting means may for example be a telescopic device or a wire. In particular, the distance between two fluid chambers can be changed by the adjusting means.

• – Einführen der Vorrichtung in eine Körperhöhle eines Patienten,
• – Einleiten eines Fluids in eine erste Fluidkammer,
• – Insufflieren des Behandlungsabschnitts mit einem gasförmigen Medium,
• – Einleiten eines Fluids in eine zweite Fluidkammer,
• – Einleiten eines Aerosols in einen zwischen den Fluidkammern liegenden Behandlungsabschnitt der Körperhöhle mit den oben genannten Vorteilen.

Further proposed is a device for medical therapy of a patient, the device comprising one or two fluid chambers and suitable for carrying out a method comprising the steps:

• Inserting the device into a body cavity of a patient,
• Introducing a fluid into a first fluid chamber,
• Insufflating the treatment section with a gaseous medium,
• Introducing a fluid into a second fluid chamber,
• - Introducing an aerosol in a lying between the fluid chambers treatment section of the body cavity with the above-mentioned advantages.

If a device with only one fluid chamber is used, it is naturally not necessary to introduce a fluid into a second fluid chamber.

Further proposed is a device comprising an orifice member having at least one opening portion of the insufflation device and a nozzle of the aerosol generating device, wherein the orifice member opens into the treatment section. In a particular embodiment of this mouth organ can be pushed with its connections through a tube into the treatment section. The tube itself has here on its outer peripheral surface, the fluid chamber in the form of about a cuff. The shape of the orifice member is limited in its outer diameter by the patient to be treated organs as well as the necessary dimensions of the aerosol generating device, and other supply lines, in particular their number and diameter. In particular, the mouth member may have the shape of a flat cylinder, the treatment portion facing the end face is either flat or convex. Advantageously, the mouth member is rounded in order to avoid injury to the organs to be treated as possible. In a particular embodiment, the orifice member may be inserted into or onto a tube passed through the fluid chamber, adhesively bonded to the tube, or otherwise fixed. Furthermore, in an alternative embodiment, the integral nature of the hose and the mouth member is provided.

The said orifice member also has at least one further passage into the treatment section. This at least one passage can be used for example for surgical tools, for sensors or for the supply and / or discharge of fluid, ie liquid or gaseous media. Advantageously, the passage in its inner diameter is adapted to an outer diameter of the guided objects. Furthermore, a pressure-tight sealing of the passage to the treatment section can be provided by sealing means, such as by O-rings.

Finally, in a further embodiment of the invention, the first fluid chamber can be passed through a trocar. In this embodiment it is ensured that the aerosol can not get into unwanted sections within the organ or into the environment.

The invention will be explained in more detail with reference to some embodiments.

It shows schematically:

1 a first therapy device in perspective view,

2 to 4 each a section through a body cavity with a view of another device,

5 and 6 each a sectional view through a fluid chamber,

7 a section through a body cavity with a view of another device,

8th and 9 each different group of objects belonging to a device,

10 and 11 each a section through a body cavity with a view of another device,

12 a device inside the esophagus and stomach,

13 a device inside the bladder,

14 and 15 a device inside the trachea.

In the 1 shown device 1 has a first expandable fluid chamber 3 , a second expandable fluid chamber 4 , an aerosol generating device 5 in the form of a to a supply line in the form of a pressure line 11 connected nozzle 15 with an inside diameter of 20 Micrometer for the production of a therapeutic aerosol and an insufflation device 6 in the form of a tube, one opening of which is approximately midway between the two fluid chambers 3 . 4 is arranged. Shown are a total of four leads 9 - 12 ; one lead each 9 . 10 for the two fluid chambers for supplying ambient air under low pressure (about 0.8 bar); the pressure line 11 filled with a substance, a chemotherapeutic agent for delivery to the nozzle 15 with a pressure of about 20 bar and the other air supply line 12 to the insufflation device for stretching a treatment section of the body cavity, which is shown below. At least the supply lines 11 and 12 are in a common hose jacket 16 taken up and through the fluid chamber 3 passed. The supply line 9 for the upper fluid chamber 3 can also through the hose jacket 16 be guided or with the hose jacket 16 into the fluid chamber 3 open out. Alternatively, the fluid or air supply for the upper fluid chamber 3 also directly to this with the supply line 9 be connected. The device shown and all other devices described above may be designed for single use. A cleaning is omitted in this case.

In the 2 shown device 1 is in a tubular body cavity 2 a patient introduced. A first fluid chamber located in an inflated state 3 seals a first upper section 6 ' the body cavity 2 , here the trachea off. A second expandable fluid chamber 4 seals a second lower section 8th the body cavity 2 , here the esophagus off.

There is also an aerosol generating device 5 a therapeutic acting aerosol 14 within a between the first and the second section 6 ' . 8th extending treatment section 13 the body cavity 2 from. Also shown are two tumors 7 that by means of the aerosol 14 be killed. All supply lines except for the supply line for the fluid chamber 3 are also here through the fluid chamber 3 inside a hose jacket 16 passed. The supply line to the fluid chamber 3 ends within the fluid chamber 3 ,

3 shows a further device with a further arrangement of the aerosol generating device 5 with nozzle 15 and the insufflator 6 ,

In 4 shows the device 1 another monitoring device 19 , in particular a camera, which is arranged between the first and the second fluid chamber, suitable for monitoring the treatment portion of the body cavity and an operating device 20 in the form of a cutting anode arrangement suitable for manipulating the wall of the treatment section of the body cavity.

The 5 and 6 schematically show how the length of at least one fluid chamber 4 by an adjusting means 21 in 6 in the form of a telescopic device with a punch acting on the fluid chamber 25 is changeable.

In 7 An extended arrangement of an alternative device is shown schematically. In particular, the aerosol generating device 5 , the camera 19 , a sensor 22 , the insufflator 6 and a suction device 22 ' within a rotary organ 23 arranged that regardless of the position of the fluid chambers 3 . 4 twisting.

In 8th are parts of a device, namely the aerosol generating device 5 , the insufflator 6 , the monitoring device 19 , the sensor device 22 , four fluid chambers 3 . 4 . 17 and 18 , an operating device 20 shown schematically with their respective supply lines. In particular, the common arrangement of the lines to the said elements within a still before the fluid chamber 3 arranged receiving tube 24 shown in a sectional view.

9 shows the parts of the device of 1 namely the aerosol generating device 5 , the insufflator 6 and two fluid chambers 3 . 4 ,

10 shows a device for use in another body cavity namely the trachea 41 , Evident is the implementation of an intubating, here a hose 24 for intubation of the patient through both fluid chambers 3 . 4 ,

In 11 is a device 1 with an adjustable fluid chamber 4 shown with an adjusting means in the form of a punch 25 corresponding 6 is adjustable.

The 12 shows a device 1 , arranged within a body cavity 2 in the form of the esophagus 26 and the stomach 27 , Also shown is a pathological area here in the form of a tumor 7 inside the stomach 27 , The device 1 includes a fluid chamber 3 and a hose passed through the fluid chamber 16 , The fluid chamber 3 in the form of a balloon seals the stomach 27 to the esophagus 26 in a body cavity section 6 ' from. The treatment section 13 is here by the stomach 27 spanned insufflated volume is formed and released from the pylorus 28 to the intestine 29 limited. The named hose 16 ends in the treatment section 13 with an orifice organ 30 with plan trained end face 31 , The mouth organ 30 is shown in an enlarged view. The outer diameter of the mouth member is about 10 mm. Another diameter may also be provided depending on the size of the organs. Usually, the diameter for an orifice organ applied within the stomach is no greater than 13 mm. On the front page 31 of the mouth organ are three openings 32 to 34 educated. An opening 32 is intended for the introduction of a gaseous medium, in this case of CO2, and is part of the Insuffliervorrichtung 6 , A second opening 33 has the aerosol generating device 5 in the form of a nozzle 15 with a nozzle inside diameter of 20 Micrometer up. The third opening 34 is optional and forms the end of a passage for performing, for example, an operation tool, a sensor 22 or a fluid supply line or a fluid drain. Not shown in detail is the connection of two fluid lines to the mouth member. In particular, the mouth organ forms 30 a round passage opening ends in relation to the front side in a connection piece, to which an insufflation hose is connected. For the nozzle 15 has the mouth organ 30 on the front side also a not shown recess with internal thread, with which an external thread of the nozzle 15 is screwable. Opposite the front 31 is also a screw provided, with a pressure hose to the nozzle 15 can be connected. During the treatment of the treatment area 13 the pressure tube is filled under high pressure, for example at 20 bar, with at least one chemotherapeutic agent present in liquid form. The liquid then exits the small nozzle orifice 35 suddenly depressurized and, as a result, within the stomach previously expanded by the insufflator with CO ₂ to a mist, the aerosol 14 atomized. It has surprisingly been found that the aerosol 14 can be distributed evenly within the stomach volume and the liquid in the form of the chemotherapeutic accordingly equally on the inner surface 36 of the stomach inflated by insufflation. Optionally, for example by using corresponding potential electrodes, the aerosol 14 also be positively charged electrically and the body of the patient on the other hand have negative potential. This ensures that the aerosol 14 with the gradient field formed by the potential difference even more uniformly on the inner stomach walls 36 distributed.

13 shows a device 1 within a body cavity 2 formed from bladder 37 and urethra 38 next to the os pubis 39 in a schematic sectional view. Shown is the occlusion of the bladder 37 in a body cavity section 6 ' inside the bladder 37 opposite the urethra 38 by means of an inflated fluid chamber 3 in the form of a balloon filled with air. As in 12 is also here a mouth organ 30 used that a nozzle 15 for the introduction of a via a high pressure line 11 adjacent chemotherapeutic agent, also an optional opening 34 a working channel and an opening 32 for the supply line 12 the fluid supply, such as CO ₂ , helium or a gas mixture in the bladder 37 for their insufflation. Inside the through the fluid chamber 3 guided jacket hose 16 , with the mouth organ 30 seals, is the high pressure line 11 and the CO _{2 line} 12 led to insufflation. An air hose 40 for filling the balloon as shown either also as a supply line 9 inside the jacket tube 16 be guided or outside of it directly with the fluid chamber 3 get connected. In the enlargement of a section of the shown 13 also opens a working channel with an opening 34 on the front side 31 of the muzzle organ 30 , This working channel can also be omitted or one or more further working channels or passages can still be arranged on the face side in the mouth member. The mouth organ 30 can reach an outer diameter of maximum 10 mm. Smaller diameters of 5-7 mm are common when using the device within the urethra 38 ,

14 and 15 show schematically a device 1 , located within a body cavity in the form of the trachea 41 , The device here includes an endotracheal tube 42 with a first fluid chamber 3 in the form of a small balloon and a hose 43 by which is usually ventilated. Here, however, in addition to the ventilation by means of gas supply 44 with oxygen or a gas mixture and gas removal 45 also according to the invention, the administration of aerosol 14 by means of the nozzle 15 and optionally the air supply 46 for another fluid chamber 4 and optionally also the implementation of further optional means through an opening 34 a working channel in the treatment section 13 , The air supply 47 the first fluid chamber 3 usually takes place outside the tube tube shown 43 , The air supply 46 to the further fluid chamber 4 can also be outside the tube and outside of the tube through the hose tube 16 respectively.

It is understood that the supply line to the fluid chamber 4 also outside to the through the fluid chamber 3 guided jacket tube to be guided can. Furthermore, it is understood that in terms of gas removal 45 that with aerosol 14 can be enriched, the ventilator, not shown here, the gas removal 45 is connected, appropriate retention means, such as filters or condensing devices should provide to the contamination of the environment outside the treatment section 13 , here the trachea 41 and to prevent the lungs. Incidentally, in a further embodiment, the second fluid chamber 4 be omitted provided it is ensured that no gas from the first of the first fluid chamber 3 covered section 6 ' can happen.

LIST OF REFERENCE NUMBERS

1

 contraption

2

 body cavity

3

 fluid chamber

4

 fluid chamber

5

 Aerosol generating device

6

 Insuffliervorrichtung,

6 '

 section

7

 tumor

8th

 section

9

 supply

10

 supply

11

 Supply line, pressure line

12

 Supply line, air supply line

13

 treatment section

14

 aerosol

15

 jet

16

 hose mantle

17

 fluid chamber

18

 fluid chamber

19

 monitoring device

20

 The surgical apparatus

21

 adjustment

22

 sensor

22 '

 suction

23

 rotary member

24

 collector tube

25

 stamp

26

 esophagus

27

 stomach

28

 pylorus

29

 intestine

30

 mouth organ

31

 front

32

Opening CO ₂

33

 opening

34

 Opening optional

35

 nozzle opening

36

 Surface, stomach inner walls

37

 bladder

38

 urethra

39

 Os pubis

40

 air hose

41

 windpipe

42

 endotracheal tube

43

 tube

44

Gas supply, O ₂

45

 gas discharge

46

 air supply

47

 Air supply.

QUOTES INCLUDE IN THE DESCRIPTION

This list of the documents listed by the applicant has been generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Cited patent literature

• WO 2012/163346 A1 [0002, 0002]

Claims (13)

Contraption ( 1 ) suitable for introduction and use within a body cavity ( 2 ), in particular an institution ( 26 . 27 . 37 ) of a patient, the device comprising: - a first expandable fluid chamber ( 3 ) for sealing a first section ( 6 ' ) of the body cavity ( 2 ), - an aerosol generating device ( 5 ) for the production of a therapeutic aerosol in a 5 ) extending treatment section ( 13 ) of the body cavity, - an insufflation device ( 6 ) for insufflating a gaseous medium (CO ₂ , O ₂ ) into the treatment section ( 13 ) of the body cavity ( 2 ). The apparatus of claim 1, the apparatus further comprising a second expandable fluid chamber ( 4 ) for sealing a second section ( 8th ) of the body cavity, wherein the treatment section ( 13 ) as a middle section between the first and second sections ( 6 ' . 8th ) is provided. Device according to claim 1 or 2, further comprising at least one item from the group: - monitoring device ( 19 ), in particular a camera, suitable for monitoring the treatment section ( 13 ) of the body cavity ( 2 ), - sensor device ( 22 ) suitable for detecting in the treatment section ( 13 ) existing aerosols ( 14 ), - operating device ( 20 ), suitable for manipulation of the wall ( 36 ) of the treatment section ( 13 ) of the body cavity ( 2 ). Contraption ( 1 ) according to one of the preceding claims, wherein a supply line of the aerosol generating device ( 5 . 15 ) through the first fluid chamber ( 3 ) into the treatment section ( 13 ) of the body cavity ( 2 ) is guided. Contraption ( 1 ) according to one of the preceding claims, wherein at least one further supply line through the first fluid chamber ( 3 ) into the treatment section ( 13 ) of the body cavity ( 2 ) is guided. Contraption ( 1 ) according to one of the preceding claims, further comprising an intubating device ( 6 ), wherein a supply line ( 12 ) of the intubating device is guided by the first fluid chamber. Contraption ( 1 ) according to one of the preceding claims, wherein by means of the insufflation device ( 6 ) a pressure between 5 mbar and 30 mbar, preferably between 10 mbar and 15 mbar within the treatment section ( 13 ) is producible. Contraption ( 1 ) according to one of the preceding claims, wherein the length of at least one fluid chamber ( 3 ) by an adjusting means ( 21 ) is changeable. Contraption ( 1 ) according to one of the preceding claims, wherein the distance between two fluid chambers ( 3 . 4 ) is variable by means of a telescopic device. Contraption ( 1 ) for the medical therapy of a patient, the device comprising two fluid chambers and suitable for carrying out a method comprising the steps of: - introducing the device ( 1 ) into a body cavity ( 2 ) of a patient, - introducing a fluid into a first fluid chamber ( 3 ), - introducing an aerosol ( 14 ) in a behind the fluid chamber ( 3 ) lying treatment section ( 13 ) of the body cavity ( 2 ). Contraption ( 1 ) according to any one of the preceding claims, further comprising an orifice member ( 30 ), which at least one opening cross-section ( 32 . 44 ) of the insufflation device ( 6 ) and a nozzle ( 15 ) of the aerosol generating device ( 5 ), wherein the mouth organ ( 30 ) into the treatment section ( 13 ) opens. Contraption ( 1 ) according to claim 11, wherein the mouth member ( 30 ) at least one further passage ( 34 . 45 ) in the treatment section. Contraption ( 1 ) one of the preceding claims, wherein the first fluid chamber ( 3 ) by a Trockar ( 42 ) can be passed.

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