DE102011102974A1 - Topical rectal application set useful for delivering local anesthetic and/or disinfecting agent during prostate biopsy, comprises rectal applicator containing local anesthetic and/or disinfecting agent, and application device - Google Patents

Abstract

The invention relates to a novel set for the topical rectal application of a local anesthetic and / or disinfectant drug (2) in the rectum (A) for a subsequent prostate biopsy, with a rectal applicator (3) and an application device having the local anesthetic and / or disinfectant drug (2) (4).

Description

The invention relates to a novel set for the topical rectal administration of a local anesthetic and / or disinfecting drug into the rectum for a subsequent prostate stance biopsy.

For the early detection of a malignant prostate disease, it is known to take tissue samples from the prostate. Prostate biopsy is a well-known procedure for taking tissue samples through the colon. In prostate biopsy, very thin tissue cylinders are removed from the prostate using a hollow needle. For this purpose, hollow needles are inserted under visual control, which is usually done by means of ultrasound, in different sections of the prostate. With the help of a trigger device while puncture or punching needles are used, which penetrate through the rectum into the prostate tissue and punch out each case a tissue cylinder.

A prostate biopsy is often perceived by the patient, even if a local anesthesia is made unpleasant and painful, especially during biopsy, the ultrasonic head of the ultrasound device in different positions must be moved.

Object of the present invention is therefore to remedy this situation.

According to the invention, a kit for the topical rectal application of a local anesthetic and / or disinfectant drug into the rectum for a subsequent prostate biopsy is now provided by the invention, wherein the set has at least one rectal applicator and an application device already containing a local anesthetic and / or disinfecting drug. Thus, the set according to the invention has as main constituents a rectal applicator to be introduced into the rectum, which is introduced before the punch biopsy. After insertion of the rectal applicator, the part to be inserted usually has only a small diameter (less than 1 cm), the drug is applied via the application device into the rectum. This medicine has a local anesthetic and / or disinfectant effect. Preferably, the drug has both a local anesthetic and a disinfecting effect, on the one hand to locally numb the area of the rectum to be perforated and, moreover, to disinfect this area. Incidentally, it is essential in this context that the drug is already contained in the application device, ie, it does not have to be rearranged separately, which on the one hand ensures sterility in each case and, moreover, contributes to the acceleration of rectal administration as a whole. After the application of the drug, the rectal applicator can then be pulled and after a short exposure time, the punch biopsy be made. Due to the local anesthetic and disinfectant effect of the drug, punch biopsy, even if multiple punctures are performed, can be made painlessly and without the risk of infection.

In a preferred embodiment of the present invention, the rectal applicator of the set according to the invention comprises a tube section to be inserted rectally and an outer abutment section connected to the tube section. The contact section is designed and provided in such a way that the rectal applicator does not completely penetrate into the rectum during the application.

In the context of the present invention, it has been found that the tube section of the rectal applicator should have a length of greater than 4 cm, preferably between 6 and 12 cm, more preferably between 8 and 10 cm and in particular between 7 and 9 cm. Such a length of the tube section ensures that, when the tube emerges from the tube section when the tube section is completely inserted, it first comes into contact with the region of the rectum in which the punch biopsy is subsequently to be carried out. In any event, even if the drug is subsequently in the rectum, the area of the rectum to be punched has been in contact with the drug for sufficient time to assure the local anesthetic effect in the right place.

Incidentally, it is understood that the pipe section should preferably have a small outer diameter. Preferably, the diameter of the pipe section should be less than 1 cm and in particular between 0.5 and 0.8 cm.

In order to avoid penetration of the rectal applicator during application into the rectum, the outer abutment section has a conical or funnel-like shape, wherein the abutment section merges on the insertion side at least substantially continuously into the tube section. The insertion-side design of the abutment section ensures that the patient does not find the introduction of the rectal applicator uncomfortable even when the abutment section comes to rest on the insertion side in the region of the anus.

For a quick and easy connection of the rectal applicator with the application device is provided in a preferred embodiment of the invention that the contact section on the outside having a leading into the pipe section connecting pin for connection to the application device. Since a simple connection between the rectal applicator and the application device is possible through the connection pin, the rectal applicator can in principle be introduced both with and without application device, the introduction with attached application device being preferred.

In this context, it is also of particular advantage that the contact section has on the outside an at least substantially circular stop surface, from which the connecting pin projects. In this case, the stop surface should have a diameter which is several times, preferably 3 to 9 times, more preferably 5 to 7 times greater than the diameter of the pipe section. This ensures, on the one hand, that the contact section can not penetrate into the rectum during application, and on the other hand, the large stop surface, which ultimately reflects on the insertion side, provides a very large pressure surface, so that the forces applied when applied from the outside distributed over a larger area around the anus.

Incidentally, in connection with the rectal applicator, it has been found that it is expedient for the tube section and the abutment section to consist of different materials, in particular plastics. So it makes sense if the tube section to be inserted consists of a soft, elastic plastic, so that any bends or movements are also possible within the rectum and during insertion. In contrast, the contact section preferably consists of a harder, more dimensionally stable plastic, so that the contact section is provided for dimensionally stable contact with its insertion-side area in the anus, which is prevented by the dimensional stability penetration of the contact section. Furthermore, a uniform distribution of forces or surface pressure during application or the pressure exerted thereon on the application device can be ensured by the dimensional stability of the contact section.

In connection with the medicament to be administered, which may in principle be any medical device, it has been found that, as a local anesthetic, lidocaine or one of its physiologically acceptable salts, in particular lidocaine hydrochloride, is particularly suitable for the intended application. Furthermore, it has been found that this active ingredient, for example in the form of lidocaine hydrochloride, should be provided in amounts of from 0.01 to 10% by weight, based on the medicament. Further preferred ranges are between 0.05 to 5 wt .-%, more preferably 0.1 to 3 wt .-% and in particular 2 wt .-%, each based on the drug as a whole.

Furthermore, it is preferred if the medicament comprises as disinfectant chlorhexidine or one of its physiologically acceptable salts, in particular chlorhexidine digluconate. For the intended application, such a disinfectant has proven to be very effective. The disinfectant, in particular in the form of chlorhexidine digluconate, should preferably be used in amounts between 0.01 and 5% by weight, based on the medicament. Other preferred ranges are 0.01 to 1 wt .-%, more preferably 0.03 to 0.08 wt .-% and in particular 0.05 wt .-%, each based on the drug in total.

Since in the rectal application subsequent prostate biopsy the ultrasound head is introduced and moved in particular for multiple punch biopsy, it has proved to be favorable that the drug also contains at least one lubricant, in particular based on propylene glycol.

Finally, the agent described above provides a drug which has three distinct actions in combination, namely as a local anesthetic, as a disinfectant and as a lubricant.

To further simplify the rectal administration, the application device is designed as a syringe filled with the drug. Finally, an application agent is provided by the syringe, which is easy to handle manually and already contains the exact amount of the drug intended for the application. In this case, the syringe outlet is then designed for tight insertion into or placement on the connecting pin of the rectal applicator. In any case, with the syringe attached, a tight interference fit between the syringe exit and the connection pin is ensured, so that it is ensured during the squeezing out of the syringe that no medicament emerges at the connection point between the connection pin and the syringe outlet.

In order to be able to carry out the rectal application and the subsequent prostate biopsy as quickly as possible, it is advisable if the set contains at least one sterile puncture agent and / or at least one sterile tube cover for the ultrasound head and / or at least a few sterile gloves and / or at least a sterile drape and / or at least one swab and / or at least one Compress has. Ultimately, all necessary for biopsy funds are provided, except for the ultrasound head. Incidentally, all means, including the rectal applicator and the application device, are preferably disposable products which can be thrown away after use.

Furthermore, the present invention also relates to a rectal applicator for topical rectal administration of a drug, with the aforementioned constructive features as such, even if this is not part of the set. The rectal applicator according to the invention has proven to be advantageous in its concrete embodiment also for topical rectal administration of other drugs.

Further features, advantages and applications of the present invention will become apparent from the following description of embodiments of the present invention with reference to the drawing, regardless of their combination in the claims or their dependency.

It shows

1 a schematic representation of a set according to the invention,

2 a representation of a rectal applicator, in particular in conjunction with a set according to 1 provided and suitable,

3 a plan view of the rectal applicator 2 and

4 a schematic representation of an ultrasound-guided tissue removal from the prostate.

In 1 is a set 1 for topical rectal administration of a local anesthetic and disinfectant drug 2 into the rectum A for a subsequent prostate biopsy. The main components of the set 1 a rectal applicator 3 and an application device 4 on. The application device 4 already has the local anesthetic and disinfectant drug 2 in a predetermined amount.

The rectal applicator 3 who as such also in 2 is shown and in principle not part of the set 1 must be, has a pipe section 5 which is intended for rectal insertion. Furthermore, the rectal applicator 3 an outer abutment section 6 on that with the pipe section 5 is firmly connected. The pipe section 5 has in the illustrated embodiments, a free length L of about 8 cm. The insertion-side length L of the rectal applicator 3 is between 9 and 11 cm, preferably in the range of about 10 cm.

With one end 7 is the pipe section 5 firmly with the contact section 6 connected. There is one end to this 7 in a corresponding opening 8th of the investment section 6 used and pressed into it and / or glued. The other, free end 9 of the pipe section 5 is rounded on all sides, so that due to lack of sharp edges at the free end 9 Injuries of the rectum A during insertion are not to be feared. The investment section 6 has insertion on a conical or funnel-like shape. The funnel area 10 is rotationally symmetric. The transition of the funnel area 10 of the investment section 6 enters the tube section essentially infinitely on the inlet side 5 above. The funnel area 10 runs with it in the pipe section 5 out, so that a smooth transition is guaranteed. On the outside 11 indicates the investment section 6 a connecting pin 12 on the outside 11 survives and for connection to the application device 4 is provided.

As can be seen in particular 3 results is the funnel area 10 and therefore also the outside 11 of the investment section 6 , from which the connecting pin 12 protrudes, circular. In this case, the outer diameter D is the outside 11 and also the funnel area 10 many times larger than the outer diameter of the pipe section 5 , In the illustrated embodiment, a diameter ratio D / d of greater than 5 exists. In the illustrated embodiment, the pipe section 5 an outer diameter of 7 mm, while the inner diameter is about 5 mm. In contrast, the outer diameter of the outside 11 , thus the largest diameter of the funnel area 10 corresponds to about 40 mm. In embodiments not shown, the diameter ratio in D / d should be greater than 2 in any case, with each decimal value greater than 2 being possible in principle.

As can be seen moreover from the individual figures, the two components of the rectal applicator 3 namely, the pipe section 5 and the investment section 6 , made of different materials. In both cases, although it is plastic, but the pipe section 5 is made of a soft elastic plastic, so that it can adapt to the shape of the rectum as needed and also favors the insertion. In contrast, there is the contact section 6 made of a harder dimensionally stable plastic, since the function of the abutment portion is not the shape adaptation, but this component ultimately serves as a stop in the outer anus area and the rest for pressure distribution in the application.

As can be seen in particular 1 results, is the medicine 2 already in the application device 4 contain. For example, 20 ml of the drug 2 in the application device 4 be included. As a local anesthetic, the drug contains the active substance lidocaine in the form of lidocaine hydrochloride. In this case, 2 wt .-% of this active ingredient are provided based on the drug. As a disinfectant, the drug contains the active ingredient chlorhexidine in the form of chlorhexidine digluconate in an amount of 0.05 wt .-% based on the drug. In addition, the drug contains a lubricant based on propylene glucol.

As it turned out 1 Otherwise, the application device is 4 designed as a syringe. There is a syringe plunger 13 and a syringe container 14 intended. Front side, the syringe container 14 a peak 15 on top of which a clasp 16 is set. After removal of the closure 16 may the tip 15 be inserted in the connecting pin. The dimensions of the top 15 and the connecting pin 12 are chosen such that there is a play-free and sealing system.

To the set 1 continue to belong in the illustrated embodiment, three puncture means 17 in the form of biopsy needles so that it is possible to take multiple tissue samples with different needles. Furthermore, the set 1 a sterile hose cover 18 , a pair of sterile gloves 19 , a sterile drape 20 , two swabs 21 and two compresses 22 on.

4 schematically illustrates an ultrasound-guided prostate stance biopsy. As it turned out 4 results, located in the rectum A is an ultrasonic head 23 in the area of the prostate 24 , About the ultrasound head 23 is a hose cover 18 drawn. Under visual control is then via an external actuator 25 a functional agent 17 through the rectum A into the prostate 25 brought to tissue removal. After tissue removal, the functional agent 17 pulled with the tissue sample and it may be to one or more other tissue sampling other puncture 17 be set.

Before carrying out the in 4 schematically illustrated prostate biopsy is initially the shutter 16 from the top 15 the application device 4 away. Then the top is 15 in the connecting pin 12 plugged in. After insertion of the pipe section 5 into the rectum A becomes the medicine 2 introduced into the rectum A. Due to the length of the pipe section 5 the introduction of the drug takes place 2 into the rectum A in the area of the prostate 24 , After pulling the rectal applicator 3 , which is then disposed of as a disposable part, distributes the drug 2 in the rectum A and dresses this. After a short exposure time then the ultrasound head 23 introduced.

LIST OF REFERENCE NUMBERS

1

set

2

drug

3

rectal

4

application device

5

pipe section

6

contact section

7

The End

8th

opening

9

The End

10

funnel area

11

outside

12

connection thread

13

syringe plunger

14

syringe container

15

top

16

shutter

17

Working medium

18

tube cover

19

gloves

20

drape

21

swab

22

compress

23

ultrasound probe

24

prostate

25

actuator

A

rectum

l

length

d

diameter

L

length

D

diameter

Claims (10)

Set ( 1 ) for topical rectal administration of a local anesthetic and / or disinfecting drug ( 2 ) into the rectum (A) for a subsequent prostate biopsy, with a rectal applicator ( 3 ) and a local anesthetic and / or disinfectant drug ( 2 ) application device ( 4 ). Set according to claim 1, characterized in that the rectal applicator ( 3 ) a pipe section to be introduced rectally ( 5 ), preferably with a length of greater than 4 cm, in particular between 6 and 12 cm, and one with the pipe section ( 5 ), outer abutment section ( 6 ) having. Set according to claim 2, characterized in that the abutment section ( 6 ) inlet side has a conical or funnel-like shape and that, preferably, the abutment portion insertion at least substantially continuously into the pipe section ( 5 ) passes over. Set according to one of the preceding claims, characterized in that the abutment section ( 6 ) on the outside a in the pipe section ( 5 ) connecting connecting pin ( 12 ) for connection to the application device ( 4 ) having. Set according to one of the preceding claims, characterized in that the abutment section ( 6 ) an at least substantially circular outer side ( 11 ), from which the connecting pin ( 12 ) and that, preferably, the outer diameter (D) of the outer side ( 11 ) by a multiple, preferably by a 3- to 9-fold and more preferably by a 5- to 7-fold, is greater than the outer diameter (d) of the pipe section. Set according to one of the preceding claims, characterized in that the pipe section ( 5 ) and the plant section ( 6 ) consist of different materials, in particular plastics, and that the pipe section ( 5 ) made of a soft, elastic plastic and the contact section ( 6 ) consists of a harder, more dimensionally stable plastic. Set according to one of the preceding claims, characterized in that the medicament ( 2 ) as a local anesthetic lidocaine or one of its physiologically acceptable salts, in particular Lidocainhydrochlorid, preferably in amounts between 0.01 and 10 wt .-%, more preferably between 0.1 and 5 wt .-% and still more preferably between 1 to 3 wt. -%, in each case based on the drug, and / or that the drug as a disinfectant chlorhexidine and / or one of its physiologically acceptable salts, in particular chlorhexidine digluconate, preferably in amounts of 0.001 to 5 wt .-%, more preferably between 0.05 and 1 wt .-% and still more preferably between 0.01 and 0.1 wt .-%, each based on the drug, and / or that the drug also contains at least one lubricant, in particular propylene glycol. Set according to one of the preceding claims, characterized in that the application device ( 4 ) than with the drug ( 2 ) filled syringe is formed and that, preferably, the tip ( 15 ) of the application device ( 4 ) for sealing insertion in or placing on the connecting pin ( 12 ) of the rectal applicator ( 3 ) is trained. Set according to one of the preceding claims, characterized in that as a further component of the set ( 1 ) at least one sterile puncture agent ( 17 ) and / or at least one sterile tube cover ( 18 ) for an ultrasound head ( 23 ) and / or at least one pair of sterile gloves ( 19 ) and / or at least one sterile drape ( 20 ) and / or at least one swab ( 21 ) and / or at least one compress ( 22 ) are provided. Rectal applicator ( 3 ) for topical rectal administration of a drug, according to one or more of the features of claims 2 to 6.

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