DE2314509A1 - SEALING APPLIED ANESTHESIC PLASTER - Google Patents

Description

Priority of 2 ^ _r _März_1272 in USA, Ser.No.237712

The invention relates to an anesthetic plaster and relates particularly relates to an improved occlusive anesthetic patch for producing analgesia in an intact condition Skin.

It is known that most people, and especially young children, are very sensitive to pain, associated with medical procedures performed on the surface of the skin. Typical Such procedures with anxiety vox pain include vaccination, immunizations, injections of various types, skin biop- sien, minor procedures, such as removing cysts,

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Postal check: Frankfurt / Main 6763

Bank - Dresdner Bank AG. Wiesbaden, account no. 276807

Moles, skin lesions, skin abrasions for Scars, needle punctures, allergy skin tests, venipuncture, etc. Obvious is the "needle phobia" and the associated anxiety and fear are a real factor in the medical treatment of some patients. Children thus fear injections while adults endure them. In spite of the bip indications both In both children and adults, essentially nothing has been done to correct this through the needle injections to alleviate the pain caused. It consists hence there is a significant need for effective means to protect the intact skin against pain quickly, effectively and to make it temporarily painless.

It is known from the "Annals of Allergy", Volume 22, pages 37-hl _t Jan. 1 ° 64 _S that plasters can be used to produce anesthesia in the intact skin. The anesthetic agent described there contains 30 % of xyIocaine. Nowhere is a sealing product disclosed as described below.

The invention is directed to an improved skin patch, that quickly and effectively anesthetizes the intact skin and the fear of various associated with it Abolish medical procedures such as needle injections. In general, the invention provides for pressing on a plaster made of gauze-like material

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fceiial, which with it Anas the si. em λ. 1: fcel is saturated, on the intact skin, to be ruined in this anesthesia zougon.

According to the method, the skin is plastered against an adhesive tape or a skin adhesive material is inserted and has a verscbJ the body af, which is generally a circular ring- ■ forni has raised vmd wild. In the closing body i ^ t added a gauze-like pillow or cushion, that is saturated with an anesthetic, one Adhesive pad holds the gauze pad in place.

When the plaster is applied to the intact skin ₉ the sealing body is effectively sealed on the skin and tries to press the gauze pad and thus the anesthesia against the skin in order to increase the speed of penetration of the anesthetic into the skin. In the preferred embodiment, the peripheral edge portions are '? of the gauze cushion coated or impregnated with a coloring material which stains the skin blue, which when transferred to the skin is virile and a frame-like contour or outline of the area of skin under anesthesia prevails after the plaster has been removed once.

The Grimdkonzopt of the invention can do a number of things PfIn:! Tor can be used for the <_a multitude of plasters between one large layer of skin next to the material and one

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large layer of overlying protective material inserted e.g. for use in intradermal allergy skin tests. Furthermore, the large layers or webs of the base material and the overlying material can be perforated so that a uniform plaster can be separated individually. Another embodiment of the invention, which enables the administration of such patches has a continuous strip in a rolled up form made of plastic overlay material that includes individual sections of separable plaster.

Further advantages, features and possible applications of the present invention emerge from the following description in connection with the drawings. Show it:

Fig. 1 is a perspective view of a seal applied anesthetic skin patch that is constructed according to the invention,

Figure 2 is an exploded view of the skin patch according to FIG. V

FIG. 3 shows a cross-sectional view of the skin plaster of FIG. which is applied to the intact skin,

Fig. K is a perspective view of a multiple plaster 'with a plurality of skin plasters, which are inserted between a plastic cover layer and a large strip of skin adhesive tape.

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Fig. 5 is an exploded view of a plurality of skin plasters applied to perforated pieces of skin adhesive and of aner perforated ones Overlay layer of thin plastic material are protected,

Figure 6 is a perspective view of a roll of individual skin patches laid on a continuous strip are made of overlay or cover plastic,

Fig. 7 is a schematic view of a multiple plaster that is applied to a person's upper arm, and

Fig. 8 is a schematic view of the upper arm of Fig. 7 after the multiple plaster has been removed, below Representation of the multiple anesthetized spots, which are formed by marking material, which on the upper arm has been transferred through the plastering material.

With reference to Flg. 1, the anesthetic skin plaster 10 according to the invention has a closing body 12 which consists of an annular casing which forms a shallow cup-like and resilient element which hangs on the adhesive body 1h. The part 16 of the adhesive body which covers the closure body is impermeable. The adhesive body 1 has k a larger surface area than the closing member so that the latter, when the patch 10 to the skin gebi-eight is J ^ Figure, "Jj, fixed in contact with the

Skin, and effective, is kept sealed against this ul-jf.

In the closure body and on that part 16 of the adhesive body sticks a cushion axis gauze-like material 25 (Fig. 2). The gauze-like cushion 25 is preferably a porous gauze material that contains a liquid or an anesthetic ointment for local anesthesia of the intact Skin can absorb. The scope of canton 29 of the Gauze pads 25 are preferably made with a blue colored pencil marked for marking the skin (hatched in intersecting lines) so that after removal the anesthetized area is quickly visible from the skin of the pillow.

Lidocaine, also known as xylocaine, with the chemical name 2-diethylamine-2,6-aceto-xylidide, is a common, localized, penetrating, nerve-blocking, spinal (for the spine), epidural and caudal anesthesia. It is particularly useful in'Verbindung with the invention, since 10 to 50 ° Lidocainsalberezeptur i in the introduction

of anesthesia in the intact skin is useful. For example, a 30 $ lidocaine ointment formulation anesthetizes 'the neighboring skin when in for 20 to 30 minutes Touch is. A typical such recipe contains the following ingredient "

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Lidocaine 30.0

Cetyl alcohol 9.2

Spermaceti 2.9

Beeswax 2.1

white paraffin oil 3 »5

liquid paraffin oil 2.1

Glycerin 3.5

Methyl paraben 0 ₉ 1

N a trium lauryl sulfate 0.7

Aluminum acetate 0.1

on
deionized water / 100.0

When the plaster 10 is on the intact skin (Fig. 3) is applied, for example by an adhesive tape or other, not shown skin adhesive, the closure body 12 pressed against the skin, and the gauze-like pad 25 is pressed against the skin, whereby the penetration of the skin by the anesthetic in the pillow is accelerated. Consequently, the intact Skin is made insensitive faster than was previously possible

The effectiveness of the anesthetic patch depends on several conditions: (i) a high concentration of 30% lidocaine, (2) a suitable carrier, (3) adequate application time (30 minutes or more), and (k) an occluding covering. The piece of gauze can be of various sizes and forruon jo as required for the intended

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Procedures are available. Before it is applied to the desired undamaged skin area, it is rinsed with acetone and alcohol. In one embodiment, the gauze on the anesthetic patch is saturated with the anesthetic cream or ointment. The anesthetic patch is then applied to the area of the intact skin. The anesthetic patch is removed from the area where it was applied after the required time of 30 minutes or more, and the area is then clearly marked with a blue border. This area is fully anesthetized in preparation for a painful procedure.

The invention can be used in various advantageous ways. For example, for intradermal allergy skin testing, a plurality of skin patches can be used on a single sheet or layer of skin adhesive material. Referring to Figure h , the multiple patch 30 has a plurality of skin patches 10 with their recessed sides attached against a base layer of skin adhesive material 35t such as tape. Each skin plaster 10 has a pad 25 saturated with the anesthetic agent, and the edges of each pad can be marked with a blue-colored skin marking material. For protection, the multiple plaster layer is covered by a plastic sheet 38 larger than the 3 ° layer. Desired-

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if so, the entire layer 30 can be sealed in a sterile package as is known. In other embodiments, the anesthetic agent can be applied to the gauze pad and the assembly packaged, or the anesthetic agent can be packaged separately and applied to the gauze immediately prior to use.

With reference to FIGS. 7 and 8, after the plastic layer 38 has been removed, the multiple plaster 30 can be applied to the skin for an interdermal allergy test (FIG. H) . The base layer 35 carries the closure body and the gauze and holds the plaster 30 snif the skin. After a period of about 10 minutes, the multiple patch 35 can be removed (Fig. 8) and the blue colored marking material on the edges of each pad is revealed, it has been transferred to the skin and forms a series of blue frame-like patches which form the Spots indicate where the anesthetic has been applied to the intact skin. Therefore, the doctor will perform his allergy test in these areas without the patient feeling any pain. Another embodiment of the invention as shown in FIG. 5 comprises a perforated base sheet or layer h0 of skin adhesive material, such as a tape, which forms a plurality of generally square or rectangular absclinitta, each of which contains a skin patch 10. A cover layer ajs correspondingly perforated plastic hl is then placed over the base layer hO in such a way that individual plasters

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10 separated individually by pulling along the perforations can be. According to another embodiment (Pig, 6) are thin plasters 10 on removed rectangular pieces of tape 45 on a continuous Strips or a roll 46 of plastic attached. In this embodiment, the plaster 10 can be through Separate λοι the roller 46 separate.

The multiple anesthetic patch is used primarily used for intradermal allergy skin tests. The gauze

O ₃
squares are 3/8 by 1/2 inch (7 by 1.7 cm) in area. A strip of resilient adhesive base material 7.5 cm (3 ") wide by 17.8 cm (" 7 ") long has 2 vertical rows of 5 of these squares which are 2.54 cm (1") wide in the box Each dex "10 small gauze area is saturated with an anesthetic ointment prior to application to the skin. The multiple patch is then placed on the upper arms or the upper back, depending on the patient's condition (the back is worn out in young children up to about 6 years of age). The application of the two multiple anesthetic patches thus each creates 4 rows of 5 anesthetized delimited skin test areas or 20 sites for intradermal allergy skin tests. Individual plasters consist of larger squares of gauze, which are delimited with a blue skin coloring pen and applied to an adhesive base material of the appropriate size, depending on the process to be carried out. These single plasters are one to two square inches or larger in size.

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functions, e.g. an injection or venipuncture a small anesthetic plaster for lumbar puncture use; a larger one is used for a two-inch square, and for minor surgical treatments, an anesthetic patch may be the size of 2 square inches or possibly 3 square inches or larger can be used.

In fact, one can theoretically form an anesthetic patch, suitable for any other suitable anesthetic purpose.

During over 9 years of experimental use of the anesthetic patch on human patients, about 880 cm (300 ounces) of the 30% lidocaine anesthetic ointment has been applied to about 3,000 patients in the form of over 250,000 patches. There were no adverse reactions or adverse symptoms at all. More than 5 years was <$> the body surface over h ig h ^e applied Lidocainsalbe to about 50 at a series of 10 guinea pigs anesthetic $ 30. There were no adverse reactions. During this guinea pig study, a 7 »6 cm (3 in. Long) scalpeiyiorsal was incised (in the surface of the back) in a guinea pig, which was then closed by 5 skin sutures. This surgical procedure did not lead to pain perception for the guinea pig! in contrast to a control guinea pig, in which such a procedure was obviously painful. , ....-. .

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The multiple anesthetic patch is experimental 9 For years to perform painless intradermal Allergy skin tests in allergy clinics and in the private practice uses Xirorden. One has objective and Subjectively observe that the anesthetic patch induces local anesthesia and painless skin tests allowed. Women especially appreciate the painlessness during skin tests. Some noted that they were very afraid of the tests but were pleased to find that they were in no pain. The most satisfactory results were found in children. Generally speaking, the elimination of the pain aspect of skin tests must have an equally noticeable effect on the relief when performing dei tests to have. Obviously the most beneficial effect is the decreased sensitivity and all that is related Been scared. The application of the anesthetic plaster creates neatly visible demarcated areas and the anesthetized skin for each allergen test. This allows a slow, accurate one. Implementation of Allergy testing as opposed to the hectic, painful application; managed this latter situation an emotionally charged atmosphere and "confusion in one struggling, screaming and scared child. !further reduces the psychological suggestive aspect of the pre-injection in the skin area in which a prophesied painless procedure similar to the anesthetic plaster should be injected, the child's sensitivity.

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These factors together thus aid the accuracy of the skin test and alleviate the difficulty in many ways in the children's allergen tests. The anesthetic plaster steers towards a scientific atmosphere and I was responsible for the procedure of allergy skin tests. In addition, the allergen test is for inexperienced people, such as medical assistants and others facilitated, who are not that familiar with the procedure. The allergen tests can be carried out without the need for them to be carried out quickly on a reluctant, uncomfortable patient

A number of seven year olds were on an experimental basis using a large single anesthetic patch Subjected 3 hours before spinal puncture. Excellent anesthesia was given, so that the spinal puncture could be done painlessly. In three-year-old children, the anesthetic plaster was used similarly at the site for a skin puncture biopsy Used for 3 hours. Obviously, excellent results have been obtained as no child is in pain felt.

A number of 18 minor surgical procedures (such as Cyst moles or birthmarks) was successful using the 2-inch single plaster for general anesthesia carried out for experimental purposes.

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The anesthetic plaster has been used experimentally on a large number of children to achieve a complete Establishing anesthesia for various procedures, such as phlebotomies, spinal punctures, and Injections. Many of these cases require repeated intravenous injections and spinal punctures.

In a large number of cases with young children, who fear the hypodermic subcutaneous injections had those for the desensitization immunotherapeutic Treatment of the allergic ailments needed, small areas were used on each arm showing the Use small anesthetic plaster the multiple anesthetic plaster turn off. The mother put these patches on some time before going to the hospital, where the injections should be given. This has been considered very successful because of fear Eliminated before these injections that children commonly have. Donating blood is a very essential requirement for health maintenance, and with the idea that donating blood is painless, so would blood donors strengthen, and the anesthetic plaster was experimental used successfully in a small number of cases. The possibility of painless blood donation A blood bank can get a lot of people to donate blood, and thus a significant increase in the number of blood donors per year.

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Lidocaine is an aminoalkylamide and is completely without Relationship to the other drugs such as nupercaine, procaine, etc. It is actually not allergenic. While In the last 9 years or more of continuous experimental use there are no allergic reactions or skin sensitization or other adverse reactions have been observed. The anesthetic plaster seems to have properties to have an ideal anesthetic agent consisting of:

(1) Effectiveness of both local application the skin;

(2) Possibility of eliminating sensitivity to pain,

(3) adequate anesthesia duration;

(4) Impossibility of causing allergenic sensitization ;

(5) Inability to reduce the dermal response to allergen skin tests. The anesthetic patch does not change the skin's reactions to allergen tests. Controlled studies showed no notable difference in skin test responses, such as k + _t 3 + t or, on the other hand, between anesthetic patch areas and adjacent control areas;

(6) free from skin irritation; and
7. Free of side effects.

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The duration of the anesthetic effect produced by the anesthetic plaster varies with the time of use. When the application time is h hours, the anesthetic effect lasts for almost 4 hours; with a 3-hour application time, the effect lasts more than 1__ hour; for a 2-hour application

H
at times more than half an hour. The anesthesia is

profound or thorough, and very complete.

The anesthetic patch suitable Art.kann by patients at home before he goes ztir clinic to the hospital or to the office, to be applied so that dex "patient in the time during which ei ¹ a painful process is subjected to an anesthetized area created This fact can make many procedures possible, especially in children, in the doctor's office rather than in the hospital or other anesthetic facility. The patient is provided with a package that includes an alcohol wipe, a small available syringe of appropriate anesthetic ointment, an aesthetic plaster and a pre-printed form with instructions for self-administration of the patient The patient actually becomes an anesthetist.

The anesthetic plaster clearly has many advantages over this other anesthetic methods for local pain-.

adherent procedure,. 3 0 9,839 / 1.027

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(1) no initial pain from needles for local anesthesia or other methods such as coolant spraying;

(2) the anesthesia is exact on that for the procedure

required area localized;

(3) there is no swelling or impairment of the Area by infiltration from the local anesthetic solution or another sprayed on Anesthetic agents;

{h) no adverse side effects from the systematic absorption of a local anesthetic agent. A very excellent benefit is in reducing the patient's anxiety and fear while performing the painful procedure. A number of cases of marked "needle phobia" where a rod of needle contraction occurs at first

Syncopic
Exertion has been shown to be improved by the use of the anesthetic plaster, so that after various consultations with the doctor when using the anesthetic plaster, the "needle phobia" was remarkably improved.

There are many anticipated uses for the anas the plasters that actually encompass any painful procedure that is carried out on the intact skin of the Body and possibly other body should be carried out. The anesthetic plaster can be used for immunization and for other injections (diabetics), skin

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biopsies, minor surgical interventions such as the Removal of cysts.;, Moles, skin lesions, Lumbar punctures, venipunctures, etc. may be used. '

While the invention is with particular reference to the use of lidocaine as an active anesthetic other non-allergenic topical anesthetics can also be used, e.g. Carbocaine or similar anesthetic agents. The penetration of the anesthesia through the intact skin can also be enhanced through the use of volatile materials such as camphor, menthol, phenol, and a particularly useful formulation included an anesthetic such as lidocaine or carbocaine, propylene glycol and Diine thylsulf oxide (DSMO). The advantage of the volatile materials is the increased penetration through the intact skin and the reduction in the time it takes to reach anesthesia. Of course Other modifications can be made to increase the effectiveness of the anesthetic agent to achieve within the scope of this invention.

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Claims (1)

Patent application 1.) Anesthetic plaster for local application on the intact skin to create local anesthesia, characterized by a coated toilet body for adhesion to the skin, a closing one Cover for the body that is placeable in contact with the skin around an occluded area To form over the skin, a cushion arranged and fastened in the closure body for receiving a local anesthetic contained in the pillow, after applying the plaster on the skin of the closure body allows the percutaneous penetration of the anesthetic into the opposite one intact and intradermal skin to generate its anesthesia increases. 2 · plaster according to claim 1 _f, characterized in that the pad has gauze, and that the anesthetic has a 30% lidocaine ointment formulation. 3 plaster according to claim 1, characterized in that that it has a covering layer of protective material, which was due to the coated adhesive body lying over the pillow. 30983b / 102 7 - 20 - ■ - 20 -. 23H509 km plaster according to claim 1, characterized in that the coated adhesive body has a plurality of closure bodies which are in contact with it and which each expand a cushion and an aesthetic agent. 5 · plaster according to claim · '+, characterized in that a plurality of closure bodies arranged in a row and the plaster is ordered in the form of a roll with separable individual plaster arrangements. «> * Patch according to claim 1, characterized in that that the anesthetic is a mixture of axial t is material in a carrier, and that the anesthetic Material a non-allergenic anesthetic of the aminoacylamide type is. 7 · plaster according to claim 1, characterized by a Device for transferring a mark to the skin to form the anesthetized area of the skin. 8. plaster according to claim 1 ,. characterized in that the Verschließköfper is brought into a proper relationship to the pad in contact with the skin to keep _s dä3 and the portion of the coated adhesive member is formed by the impermeable closing member. 309 839/102 7 - 21 - 9. plaster according to claim. G ₉ characterized in that the carrier is a volatile carrier and the anasizing material is lidocaine. 10. Plaster according to claim 1, characterized in that that the anesthetic agent Lidocaiu in a vehicle is. 309839/102? L e rs e ι te