WO2010076355A1

WO2010076355A1 - Device for applying a contact anaesthetic

Info

Publication number: WO2010076355A1
Application number: PCT/ES2009/000600
Authority: WO
Inventors: Luis Emilio Pablo Julvez; Maria Luisa GÓMEZ MARTÍNEZ
Original assignee: Instituto Aragonés De Ciencias De La Salud; Universidad De Zaragoza
Priority date: 2008-12-30
Filing date: 2009-12-29
Publication date: 2010-07-08

Abstract

Device for applying a contact anaesthetic, such as those used mainly in superficial ophthalmological surgery for application of a local anaesthetic, characterized in that it consists of a porous strip of gelatine sponge which is flexible and preferably rectangular in shape with a small thickness, which is impregnated with a topical anaesthetic and is deposited on the surface to be treated, leaving it to act for a short period of time so that anaesthetic is released onto said zone, being discharged at the rear. The invention described offers the main advantage of achieving an intense anaesthetic effect only in the desired zone, leaving completely unaffected the sensitivity outside of the zone covered by the strip, ensuring total co-operation on the part of the patient and avoiding the injections and drawbacks associated with other anaesthetic devices, all this being achieved by means of a low-cost device which is simple to use.

Description

PE ANESTHESIA APPLICATION DEVICE

CONTACT

The present specification refers, as its title indicates, to a device for application of contact anesthesia, of the type used primarily in ophthalmic surface surgery for the application of anesthesia locally, characterized in that it consists of a porous sponge sheet Jelly, flexible and preferably rectangular and reduced thickness, which is impregnated with a topical anesthetic and deposited on the surface to be treated, leaving it to act for a short time releasing the anesthetic on said area, later discarded.

Traditionally, conventional anesthetic devices and techniques have been used in ophthalmic surgery by local injection into the eyeball using a syringe and needle of a small amount of anesthetic. This type of anesthesia, despite its proven desensitizing efficacy, presents numerous problems and discomforts facing the patient, mainly due to the pain caused by needle punctures in the eye, due to the large number of nerve branches existing in the globe ocular. These punctures also present the added problem of lengthening the healing time and being a possible source of infections or other problems, as well as requiring a very elaborate injection technique to avoid causing unnecessary damage to the patient. The use of injections as an anesthetic medium in ophthalmologic surgery also causes a high level of stress in the patient, hindering and complicating the subsequent surgery, and in many cases forcing the patient's general sedation, with subsequent complications.

At present, and to try to solve these problems, topical anesthesia has begun to be used in cataract surgery, which has produced a real revolution in pain inhibition techniques in the field of Ophthalmology. Topical anesthesia consists of the application of lidocaine or other anesthetic agents such as those described in the 200300131 Patent "New formulation for topical anesthesia, its corresponding single dose kit and its applications in surgery" or in European Patent 89302697 "Method and composition for ophthalmic analgesia using rhodocaine ", by means of simple irrigation on the surgical field of the eyeball, using devices as claimed in Patent 466084" Injector for administration in the form of spraying or spraying a liquid anesthetic ", and provides some levels of patient comfort acceptable in many cases. The undoubted advantages and simplicity of the technique have encouraged many surgeons to export these techniques, adapting them to specific surgeries such as strabismus, vitreoretinal surgery or Glaucoma surgery, but it also has the disadvantage that it is frequent anyway The need for a more or less deep intravenous sedation and sometimes the change of technique or the addition of subconjunctival or subtenonian anesthetic. On the other hand, it presents the added problem that a previous selection of patients is necessary and the surgeon is subjected to an added tension because certain maneuvers can awaken the painful sensibility of the patient in some steps of the surgery because this technique does not it barely allows accuracy in the area to be anesthetized, which for security reasons obliges to greatly expand the part of the irrigated and therefore anesthetized eyeball.

The advantages of topical anesthesia in glaucoma surgery are even clearer than in crystalline surgery, the absence of injection in the muscular cone and the non-application of the Honan balloon prevents sudden changes in intraocular pressure, we also avoid the risk of chemosis and subconjunctival hemorrhages, without neglecting the possible paresis or muscular paralysis and events, fortunately infrequent, such as the inadvertent perforation of the eyeball (5,11), however most of the Surgeons who use topical anesthesia in glaueoma surgery Ia apply only in combined surgeries and not in simple trabeculectomy. The reasons are multiple, first of all those derived from the patient: on the one hand, cauterization and certain surgical steps such as iridectomy produce more or less painful situations; The introduction of intracamerular lidocaine in cataract surgery would somehow avoid such inconveniences. On the other hand, the transition to topical anesthesia, as happened in phacoemulsification, causes reluctance in a good number of ophthalmologists since it forces a good number of changes in the usual procedures and added inconveniences, the upper rectum traction is impossible, eliminates the aquinesia and causes a higher level of surgical stress at least during the learning curve.

As a solution to the aforementioned problems, anesthetic gels began to be used, such as the one found in Patent 549867 "Procedure for preparing a pharmaceutical composition based on ametocaine for topical use", from other fields, such as urological surgery, but soon there were annexed problems such as that of doubtful sterility and the difficulty of its elimination prior to surgery, which may complicate it unnecessarily.

The application of anesthetic by means of surgical gels is not a new idea, some authors used perilimbar touches with hemostats in cataract and combined surgery, in this way it is intended to increase the penetration of the agent in the area to intervene, but it is a technique with disadvantage that it requires an exceptional manual ability, in addition to having the added problem of its low effectiveness and penetration, which makes it of little application, only for very superficial surgery. In addition, it is common to find appreciable levels of discomfort for the patient and the surgeon despite using anesthetic gels or presurgical impregnation techniques. To solve the problem that currently exists in local anesthesia devices and techniques, especially for ophthalmologic surgery, the device for application of contact anesthesia object of the present invention has been devised, which consists of a porous sheet of flexible gelatin sponge and of reduced thickness and preferably rectangular basic shape, although obviously it can be trimmed to adapt to areas with specific forms of the area of anesthetic coverage. This sheet, thanks to its characteristic porosity, is impregnated with a topical anesthetic, such as any of those based on lidocaine, and is deposited in intimate contact on the surface to be treated, for example the conjunctive-scleral bed, leaving it to act for a while. releasing the anesthetic over said area, withdrawing and later disposing of it.

This device for application of contact anesthesia that is presented provides multiple advantages over the devices currently available, being the most important that allows an effective desensitization both superficial and deep, of a specific and clearly defined area, keeping the adjacent parts outside the surgical area with its normal sensitivity and functioning.

It should also be noted the absence of pain produced in certain a priori painful maneuvers, such as bipolar coagulation or iridectomy, and that with topical anesthesia produce greater or lesser degree of discomfort or even pain even by introducing anesthetic into the anterior chamber.

Also highlight the advantage that implies that, as it is a non-bleeding technique, pain and bleeding and the irritation usual in other techniques are avoided, leading to a better and faster recovery of the patient.

Another undeniable advantage of this device is that it allows both sedation and patient selection to be avoided, even allowing it to move the eye during anesthesia, in addition to allowing a fluid and natural communication with the patient that transmits safety and tranquility, thus obtaining an effective collaboration during surgery that results in greater effectiveness and elimination of stress both in the patient and in the doctor, in addition to significantly improving post-operative recovery times.

We must highlight the undeniable improvement in the levels of anesthesia, comfort and safety for the patient who produces contact anesthesia using this device against conventional topical anesthesia, a valid and applicable alternative in a wide range of patients undergoing glaucoma surgery and other surgeries achieving a sensitive decrease in the level of pain in the patient during and after the surgery and in the surgeon's stress level.

This device presents the great advantage of being capable of being used for all types of superficial eye surgery, especially in cases of glaucoma and cataracts, strabismus, traculectomy, perigion, deep scleretomia, etc., as well as for any type of mucosal intervention. , for example in maxillofacial, oral, otolaryngological surgery, etc.

To better understand the object of the present invention, a preferential practical embodiment of a device for application of contact anesthesia has been represented in the attached drawing.

In said plane, Figure -1- shows front and side views of the device for application of contact anesthesia, with a very enlarged detail showing its porosity

Figure -2- shows a simplified example of application of the device for application of contact anesthesia in ophthalmic surgery.

Figure -3- shows two simplified views of the device for application of contact anesthesia in contact with the eyeball in ophthalmologic surgery. The device for application of contact anesthesia object of the present invention, consists, as can be seen in the attached drawing, of a porous sheet (1) of gelatin sponge, flexible and of reduced thickness and preferably rectangular basic shape, although obviously it can be trimmed to adapt to areas with specific forms of the area of anesthetic coverage, allowing an exact location. This sheet (1), thanks to its characteristic porosity (2) is impregnated with a topical anesthetic (3), such as any of those based on lidocaine, and is deposited in intimate contact on the surface to be treated (4), by example entering the bottom of the superior conjunctival sac of the eyeball, leaving it to act for a time, preferably between two and six minutes, releasing the topical anesthetic (3) on said area. During this time the porous lamina (1) impregnated with topical anesthetic (3) is held in place by its own adhesion complemented, for example, by the patient's own eyelid action (5) (6), acting on the part of the eyeball located under the porous sheet (1).

Once the specified time has elapsed, the porous sheet (1) is removed from its place and subsequently discarded, the desired part being perfectly numbed and delimited, being able to begin with the surgical process.

According to our experience, contact anesthesia using this porous sheet (1) provides optimum levels of anesthesia with the advantages mentioned above, however, strict premises that allow adequate surgery must be observed. The porous sheet (1) must cover the entire surgical area so that the contact area will remain anesthetized while any non-contact area, for example the lower conjunctiva, maintains all its sensitivity, thus avoiding any touch, traction or grip. over the non anesthetized area.

The duration of contact of the porous sheet (1) on the area is another important factor, and must be maintained for a few minutes in order to allow the absorption of the anesthetic in the scleral plates. The blepharostat must be rigid and comfortable enough to withstand the muscular pressure without yielding. It is also necessary to communicate as smoothly as possible with the patient who transmits safety and tranquility, in this way, in most cases, effective collaboration will be obtained during surgery.

It is voluntarily omitted to make a detailed description of the rest of the particularities of the device that is presented or of the surgical procedure, since we consider that the rest of these particularities are not subject to any claim.

Once the nature of the present invention has been sufficiently described, as well as a way of putting it into practice, it only remains to be added that its description is not limiting, being able to make some variations, both in materials and in shapes or sizes, as long as said Variations do not alter the essentiality of the characteristics claimed below.

Claims

1 - Device for application of contact anesthesia, of the type used mainly in ophthalmic surface surgery for the application of anesthesia locally, characterized by being constituted of a porous sheet (1) of flexible, reduced thickness jelly sponge and with a preferably rectangular basic shape, impregnated with a topical anesthetic (3), such as any of those based on lidocaine, which is deposited in intimate contact on the surface to be treated (4) leaving it to act for a time, preferably between two and six minutes, releasing the topical anesthetic (3) on said surface.

2 - Device for application of contact anesthesia, according to the preceding claim, characterized in that the fixation of the porous sheet (1) impregnated with topical anesthetic (3) in place during this time is carried out by its own complementary adhesion, for example, by the patient's own eyelid action (5) (6), acting only on the part of the eyeball located under the porous sheet (1).

3 - Device for application of contact anesthesia, according to the preceding claims, characterized in that the porous sheet (1) is removed from its place after the specified time has elapsed and subsequently discarded, the desired part being perfectly numbed and delimited, being able to start With the surgical process.

4 - Device for application of contact anesthesia, according to the preceding claims, characterized in that the porous sheet (1) is of the appropriate dimensions to cover the entire surgical area, allowing an exact location, so that the contact area remains anesthetized while that any non-contact zone maintains all its sensitivity, thus avoiding any touch, traction or grip on the non-anesthetized area.