DE2622111A1 - EXTENSION PROBE FOR THE EXPANSION OF BODY CAVES - Google Patents

Description

MÜLLER-BORE · GROENING · DEUFEL · SCHÖN · HERTEL

PATEST LAWYERS

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DR. WOLPQANQ MOlLBR-Βθηβ

(PATENT AWAY from isar-ie7a> HANS W. aROEMIN «, DIPU-INQ. DR. PAUU D BU fm UOIPl-CHSM. Often. ALFRSO SCHÖN, OIPI_CHaM. WEFtNBR HKHTBL ₁ DIfU-PHYS.

J / 0 1O-96/1

Ortho Pharmaceutical Corporation
Raritan, New Jersey,

UNITED STATES. _

NEAR RANGE

Expansion probe for expanding body cavities

The invention relates to an expansion probe for expanding
Body cavities according to the main patent (P 24 10 933.9),

In medicine it is often necessary to widen body cavities in order to perform surgical interventions
Eliminate obstruction or free passage for surgical instruments and devices
create. For example, in order to scrape the uterus, the cervix, i. E. the cervix, widened in order to introduce a curette as gently as possible for the patient
can. If a relatively safe and practical
If a dilatation method were available, numerous other dilatation procedures could be performed on body cavities according to the medical indication. The difficulties encountered in dilating the cervix indicate that the present angowon ^ oron - ni ι af ^ an ^ gyy ^ rf ahron

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ORIGINAL INSPECTED

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the needs of both the doctor and the patient do not match, '* - * ■ *'

The cervical canal has an anterior limitation, the orificium externum (ostium uteri), and a posterior limitation, the orificium internum. The length of the cervical canal is indi- Viduell different, usually on the order of about 2 cm. »The cervical canal itself is stronger elastic than the anterior and posterior boundaries of the cervical canal. The posterior limitation of the cervical canal is stronger narrowed and less easy to expand than the front boundary.

To widen the cervix

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inserted into the cervix ^^ where it is filled with body fluid comes into contact, thereby guicllt. the laminarial pen ' and causes widening of the cervical canal. This ^

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"is extremely slow; generally about 10 to 12 hours is significant expansion required, "«> medical examination procedures

required, "«> ^ £ ah3aea »for modern

so-called / He-

g ^ r ^ pens, a series of - solid, rod-like instruments with graduated diameter. First the doctor inserts a Hegar ^ pen with a small cross-section into the Cervical canal, removes the dilatcü & replaces it with a dilater with the next larger cross-section. This continues until there is sufficient expansion of the cervical canal is reached. Usually this takes two to three minutes, Usually this action is for painful to the patient. This measure is often used

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therefore performed under anesthesia. Even with the use of local anesthetics, this measure is for the patient unpleasant. This is presumably due to being disproportionate strong longitudinal forces are required to achieve a proportionate low transverse force to sufficiently expand the cervical canal. In addition, the use of local anesthesia already uncomfortable as such. . '·

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spit of numerous efforts so far could not be effective, reliable and easy-to-use dilatation probes can be created.

In the journal Ginekologia Pol ska, vol. 32, Kr. 8 (1961), pages 245 to 250, the serious risks are shown which the currently used dxlatation methods entail. Possible consequences are uterine perforation, cervical laceration and abdominal complications. The authors of this publication tried to solve the problem by using a gumra tube attached to one end "which is surrounded on the outside by a mesh made of a polyamide -what *. This probe is then inserted into the cervical canal and then filled with air. In this way γφφ & _{auij J%} the ^ cervical canal is exerted pressure and an enlargement is achieved.

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are two, people requiredi Γ ⁴ —f "iτΐ" Ρ ^ ητΓΐίττι drives the

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Probe eiK / while the other regulates the pressure in the probe. Undoubtedly, two manipulators are required because through the application of pressure the rubber tube from the cervical canal either into the uterus if it has been inserted too deeply or slips out into the vaginal canal. Therefore, a person is required to hold the rubber hose precisely in place and to ensure that it remains in the cervical canal while the other person applies the pressure regulates in the rubber hose. ThisSüeiJaode is therefore also impractical. ■

In contrast, the main patent already gives an expansion probe for expanding body cavities, in particular the cervical canal,

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which allows a relatively painless and easy expansion by a single person.

The object of the invention is this expansion probe to improve, in particular to simplify, their use.

This task is solved by an expansion probe of body cavities, with a relatively inelastic, non-expandable, collapsible, inflatable shell made up of two parts, the first part of which when inflated a relatively constant diameter and a sufficient length to close a Body cavity with more than one mouth, and the second part adjoining the first part has a terminal, enlarged, represents a pear-shaped section, the diameter of which is greater than that of the envelope when inflated, with an insertion tube which extends from the outside through the first part into the interior of the second part a shield near the entry point of the first part and in connection with the insertion tube, whereby through the insertion tube a pressure fluid can be introduced into the shell, according to the main patent ... (P 24 10 933.9), characterized by the fluid below Pressurizing device which is integral with the introducer tube at a location external to the sheath is trained- '

The invention is explained, for example, with the aid of the drawing. Show it:

1 shows a first expansion probe;

FIGS. 2 and 3 show the expansion probe of FIG. 1 in the cervix; Fig. 4 shows a modified expansion probe and

Figs. 5 and 6 show the expansion probe with a first and second, respectively

Fluid pressure generator.

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In Figure 1 1 shows the dilator of the invention in set ^ blasenem state outside a body cavity, the dilator includes an insertion tube 2 which is surrounded by a collapsible, relatively little or not expandable sheath (in its non ^ collapsed form). The sheath 3 has a relatively constant cross-sectional diameter and is attached at one end to a shield 4 and connected to the insertion tube 2 and the shield 4 in a fluid-tight manner. An extension tube 5 protrudes through the shield 4 and connected to the insertion tube 2. The dilator is used in practice so that the shield 4 _f 6 illustrates the distal end of the proximal end and the bulbous member. The introduction tube 2 is preferably provided with a plurality of openings 7 through which a gas or a liquid, called fluid for short, can enter from the introduction tube 2 into the interior space formed by the casing 3. The extension tube 5 is connected to a Fluid-r pressure generator according to FIGS. 5 and 6. The fluid is preferably a chemically inert, physiologically compatible, gaseous or liquid fluid, such as carbon dioxide, physiological saline solution or distilled water,

The use of the dilator of the invention is explained below in connection with the dilatation of a female uterine fial. The expansion probe can of course also be used to expand other body cavities or vessels. The expansion probe 1 is preferably inserted into the cervix without prior dilation. The distance between the shield 4 and the enlarged pear-shaped part 6 of the dilator allows contact along the entire length of the cervix through the sheath 3, including the inner and outer cervix 9 and 8 from.

Fig, 2 shows the dilator in the cervix in non-inflated

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Shape. The pear-shaped part 6 of the expansion probe protrudes into the Geöäic Mutterhöhle- 'into it. The sheath 3 is preferably 2 up to 3 cm long. The human cervical canal is about 2 to 2.5 cm long. Preferably, therefore, the sheath 3 has a slightly larger length to ensure adequate closure. Expansion probes of the invention for other body cavities and vessels must be dimensioned differently accordingly.

To make it easier to insert the dilator into the cervix, the diameter of the sheath 3 is not inflated Condition preferably about 2 to 4 mm. The insertion tube 2, which is preferably made of a rigid or medium. rigid plastic or corrosion-resistant steel is formed, is surrounded by the "shell 3 with a small diameter and can thus be easily inserted. Preferably, the insertion tube 2 ends near the end of the pear-shaped Part 6, although in FIGS. 1 and 2 the insertion tube 2 ends at a considerable distance from the pear-shaped part 6.

The shell 3 is made of a relatively inelastic, non-stretchable material, such as a polyurethane or a vinyl chloride polymer or an ethylene-vinyl acetate copolymer manufactured. Particularly preferred materials for the material of the shell are thermoplastic polyurethanes with a Molecular weight from 20,000 to 80,000, preferably 40,000 up to 50,000 (e.g. Roylar E-9 polyurethanes). It was found that the material of the shell 3 from a relatively inelastic material must be made for two reasons. Since both the inner and the outer opening of the cervical canal offers a relatively stronger resistance to an enlargement than the main part of the cervical canal, sheaths made of a relatively elastic material are preferred

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widen the middle part of the cervical canal. Introducing a curette or other device into the uterus would be disturbed. The relatively inelastic Sheath therefore ensures that both the inner and the outer opening of the cervical canal are approximately in the the same order of magnitude as the cervical canal; cf. Fig. 3. The term "relative" used here inelastic "is intended to have the same meaning as" relatively inextensible and pliable. "Experimental it was found that the use of thermoplastic polyurethanes of the aforementioned type as material for the shell 3, which have a diameter of 2 to 4 mm when not inflated and a diameter when inflated of 12 to 20 mm, with use to be described in more detail an expansion of 8 to 12 mm in 2 to 10 min allowed.

As soon as the expansion probe 1 is inserted into the cervix, the extension tube 5 is inserted into the insertion tube 2 and a pressurized fluid is introduced through the openings 7 into the interior space formed by the shell 3. Since the expansion probe is a has enlarged part 6, which is not constrained by contact with body tissue, can be introduced by insertion of a pressurized fluid inflate the enlarged part 6 first. The shell 3, which on the resistance of the wall of the Cervical canal, inflates more slowly than the enlarged part 6. Due to the different behavior of the enlarged part 6 with respect to the sheath 3 is prevented that the expansion probe is pushed out again will. During the further introduction of the pressure fluid, the shield 4 prevents the expansion probe from sliding in the uterus. The expansion probe w; i; rd with any ^ physiological compatible pressure fluid at a pressure of about 0.3 to 0.6 at, preferably 0.35 to 0.6 at. Pressurized fluid, carbon dioxide is preferred, but liquids such as physiological saline can also be used v / earth.

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As already indicated, the sheath of the expansion probe can be made using a gaseous or liquid fluid be inflated. A check valve is preferably used, which is located at a connection point 12 the expansion probe and the fluid reservoir is located. That Check valves can be made of any suitable material, but check valves have proven themselves made of plastics proved to be the most suitable. If gaseous fluids are used, the gas can be converted into a suitable container --- 14, as shown in Fig. 5, filled will. If a liquid fluid is used, it is placed in a container such as a syringe 16 (see Fig. 6). kept. In a preferred embodiment of the invention, the container is after its filling on the desired volume permanently connected to the check valve by means of a suitable adhesive. Suitable self-curable adhesives, solvent-based adhesives, or hot melt adhesives such as self-curable adhesives Cyano acrylate can be used. In the case of a permanent connection achieved in this way, a one-piece expansion probe as shown in Figs. 5 and 6 is obtained. If the one-piece expansion probe is used, there is no risk of excessive inflation of the envelope, since a predetermined amount of fluid is used. Therefore, the body canal is only stretched as far as for the implementation the intended intervention is necessary. In this way the risk of injury to the patient is increased strong inflation of the expansion probe extremely low.

In one embodiment of the invention, a container of the type as used for aerosols. The container can be made of any suitable material, for example aluminum, glass or Plastic. The valve of the container can be a (side-actuated) tilt valve, a vertical (upright)

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Be a valve or a metering valve. The preferred embodiment provides an aluminum container with a tilt valve. The valve is attached to the container in a manner known per se, and the container is filled with a gaseous fluid. The internal pressure of the container can be from 1.05 to 1.75 at (15 to 25 psig) :; however, the preferred pressure range is 1 _f 4 to 1.55 at (20 to 22 psig). The valve is designed so that the container shaft extends snugly into the open end of the dilator and depresses the membrane therein. The shell of the expansion probe can be evacuated by pushing through the membrane of the valve from the outside before it is glued.

When the dilator has been inserted into the body cavity, the sheath is inflated by simply removing the valve seat is depressed or the cartridge is lifted. This actuates the outlet valve of the container, so that the contained there Fluid can fill the entire system to an equilibrium pressure. The back pressure from the expansion probe pushes the membrane of the check valve against the canister shaft to form a seal that allows for continuous inflation the shell guaranteed. For example, with an outlet pressure of the container from 1.4 to 1.5 at (20 to 22 psig), the Envelope diameter after inflation] 4 to 16 mm and the same ^ container weight pressure 0.7 to 0.85 at (10 to 12 psig). After a reasonable dwell time, preferably 5 to 10 minutes, the cover can be removed from the body cavity in the inflated state, or by removing the insert / The pressure can be released from the feed shaft. The whole unit can be thrown away after use.

In another embodiment of the invention, a suitable disposable plastic syringe 16 is preferably used with a yolurpen. of 20 cm, with a check valve permanently connected. The syringe barrel is completely filled with the liquid fluid, and the excess

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Liquid is removed with the plunger through the valve until 10 to 15 cm of liquid remains in the syringe. Care must be taken not to trap air in the syringe during this process. That The permanently connected system of check valve and syringe can be pressed into the valve seat on the expansion probe to obtain a one-piece system. The envelope can be evacuated by squeezing at the same time.

When the dilator has been inserted into the body cavity, the sheath can be inflated simply by using the plunger the syringe is advanced. The actuation takes place in such a way that the pressure generated by pressurizing the fluid the membrane of the check valve opens so that the envelope fills up with the fluid. The fluid back pressure causes a seal of the membrane so that the envelope remains inflated without exerting external pressure. For example, with one Syringe filling of approx. 10 cm and a diameter of the shell of approx. 14 to 16 mm can be expected. The inflated or stretched Sheath can simply be withdrawn from the body cavity after the appropriate residence time, or the sheath can be left collapse by severing the insertion / delivery shaft. The whole unit can be thrown away after use will.

The manipulation of the expansion probe of the invention can be done by a single person who introduces the expansion probe and with it Pressure applied. As soon as the dilator is under pressure, the body cavity is expanded within one For a very short period of time of the order of 2 to 3 minutes, practically painless and without anesthesia. Of the The patient can thus remain fully conscious and perceive the introduction, surprisingly it was found that in general no local anesthesia has to be carried out either. Some doctors will use local anesthesia prefer to reduce the discomfort caused by touching the hook with the cervix However, this would be independent of the particular type of

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Fig. 3 shows the position of the expansion probe in the cervix the inflation. Both the inner and the outer opening of the cervical canal 8 and 9 are approximately of the same order of magnitude expanded. After inserting the dilator in the manner described above and after sufficient expansion of the cervical canal, the expansion probe can be removed again and the patient can be removed according to the medical indication be treated. Often the extent of the enlargement is so satisfactory that the dilator is free in the cervical canal can be moved and removed from the canal without the need to ventilate the system,

The dimensioning of the different parts of the expansion probe the invention depends on the particular body cavity to be expanded. To widen the cervical canal, shield 4 a diameter of 1 to 2 cm, preferably 1.5 cm, the shell 3 a diameter of 8 to 20 mm, preferably 10 to 12 mm when inflated and 1.5 to 4 mm, preferably 2 to 3 mm, when not inflated own. The diameter of the insertion tube 2 and the extension tube 5 is about 1 to 1.5 mm. For use as a dilator for the trachea or esophagus, these dimensions must be increased, and each part of the dilator "must be made of a material with sufficient flexibility to avoid the risk of perforation on a Limit minimum size.

It will be apparent that modifications can be made to the extensometer of the invention. For example must the openings 7 are not necessarily arranged laterally in the insertion tube 2, but it can also be the open end of the Insertion tube 2 serve to introduce the pressurized fluid. In the seal between the shield 4

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and the shell 3 either at one point on the shield 4 itself and be arranged away from the entry point of the insertion tube 2, or it can be at a point on Insertion tube 2 can be arranged at a distance from the shield 4.

The dilatation probe of the invention is also suitable for the delivery of drugs. In this way the expansion a body cavity and perform therapy at the same time. In certain circumstances it is not necessary to have the Expand body cavity to a significant extent. For this purpose, for example, the expansion probe 1 can be enlarged, pear-shaped Part 6 be impregnated with a drug or drug. The expansion of the cervix is then accompanied from a slow leaching of the medicinal substance or medicament * - by means of - from the device itself.

This can be important when using abortion drugs and labor pills. In addition, the Sheath 3 be impregnated with a drug or drug, so that when the sheath comes into contact with the cervical canal at the Surface of the cervical canal of the medicinal substance in high concentration is present.

As an alternative to impregnation, the enlarged pear-shaped part 6 according to FIG. 4 can have one or more Depressions 10 may be provided. These wells can be filled with a drug or medicine. To the insertion of the expansion probe and the filling of a pressure transmission medium, the depressions 10 are outward and release the drug into the uterus.

The examples illustrate the invention. Unless otherwise specified, an expansion probe of the type shown in FIG. 1 and 2 is used. The shell 3 has in inflated, not exn

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knife of 12 mm. The wall thickness of the shell is 0.25 mm. The enlarged pear-shaped part 6 has a maximum diameter of 15 mm. The insertion tube 2 is made of corrosion-resistant steel. Insertion tubes made of a polyurethane were used in prototypes. Carbon dioxide was used as the pressure fluid. In all patients, except in the case of Example 1, lidocaine was used as a local anesthetic, in order to keep the uncomfortable feeling when engaging the hook on the cervix to a minimum.

example 1

A 16-year-old patient. Nullipara, in the 6th week of pregnancy, an extension tube is inserted into the cervix without anesthesia (because of a known allergic reaction) introduced. Applying a pressure of 0.32 at to the expansion probe for three minutes produced some cramps, however, fewer uncomfortable feelings than using a hook and much less uncomfortable feelings than the subsequent evacuation of the uterus by aspiration. After removing the dilator, an 8 mm curette can be used can be inserted into the cervix with little resistance.

Example 2

A 19-year-old patient, nulliparous, in her 7th At the 1st week of pregnancy, a dilator is inserted into the cervix. Initially, the dilator will be using for two minutes a pressure of 0.35 at and an additional two minutes with a pressure of 0.35 at and a further 2 minutes with a pressure of 0.42 at applied. The patient cannot

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observe pleasant appearances. The cervix can be expanded to a little more than 9 mm.

Example 3

A 24-year-old female patient, nulliparous, in the 8th week of pregnancy, a dilator is inserted into the cervix. At a pressure of 0.35 atm, the patient feels a somewhat uncomfortable feeling which subsides after the first two minutes. After a total of three minutes of pressurization at 0.35 at, the pressure is increased to 0.42 at for a further minute. The expansion of the cervix is 9 mm. the unusual length of time to dilate is due to a very strong cervix.

Example 4

A 20-year-old patient, nulliparous, in her 7th Week of gestation, a dilator is inserted into the cervix and one minute with a pressure of 0.42 at and pressurized 0.49 atm for two more minutes. The patient cannot feel uncomfortable observe, and the expansion of the cervix is 9 mm.

Example 5

A 21-year-old patient, nullipara, is eight weeks pregnant and is inserted into the cervix with a dilator. After three minutes of pressurization at O _f 42 at, the expansion of the cervix is 9 mm.

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In each of the above examples, except for Example. 3 _? The inflated dilator can easily be moved in the cervical canal. I can even be completely removed and reinserted painlessly. In example 1, this was not possible because of the patient's very strong cervix to turn off

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Claims (1)

tan. .tan s. p. ι. ΐί c. h ever " Jy expansion probe for expanding body cavities, with a relatively inelastic, non-expandable, collapsible, inflatable shell made of two parts, of which the first part, when inflated, has a relatively constant diameter and a length sufficient to close a body cavity with more than one Mouth, and the second / part adjoining the first part represents a terminal, enlarged, pear-shaped section, the diameter of which is greater than that of the envelope in the inflated state, with an insertion tube which extends from the outside through the first part in the interior of the second part extends, with a sign near the entry point of the first part and% n connection with the insertion tube _for a pressure fluid is introduced through the insertion tube into the envelope,
according to main patent ,,. (P 24 10 933.9), characterized by a device (.14Jl 6) which pressurizes the fluid ,. the one with the insertion tube (2) is formed uniformly at a point lying outside the casing (3). 2, expansion probe according to claim 1, characterized in that the fluid ^ pressure generator a predetermined amount of fluid records, 3, expansion probe according to claim 1, characterized in that the Fluid-r pressure generator is a syringe (16). 4, expansion probe according to claim 1, characterized in that the fluid pressure generator is a pressure vessel (14). 609851/0300 -17 C retrospectively changed 5. expansion probe according to claim 4, characterized in that the fluid in the fluid pressure generator is carbon dioxide. 6. expansion probe according to claim 1, characterized in that the first part has a sufficient length for closure the entire length of the; human cervixka.na.ls. Has, 7. expansion probe according to claim 6, characterized in that the first part has a diameter in the inflated state from 12 to 20 mm. 8. expansion probe according to claim 7, characterized in that the first part has a diameter in the deflated state from 1.5 to 4 mm. 9. expansion probe according to claim 8, characterized in that the. first part and the terminal, enlarged pear-shaped Section (6) consists of polyurethane with a molecular weight of 20,000 to 80,000. 10. expansion probe according to claim 9, characterized in that the insertion tube (2) is at least semi-rigid. 509851/0300