RU2207096C2 - Device for postoperational tamponade during operations on middle ear - Google Patents

Abstract

FIELD: medicine. SUBSTANCE: tamponade should be carried out with a tampon as an elastic balloon supplied with connective tube and controlled valve. Physiological solution is, moreover, used as working body for balloon's filling. Internal volume of elastic tank corresponds to 2-5 ml, external surface has got the layer of medicinal lubricating impregnation substance. The innovation provides decreased terms of healing and decreased painful feelings at postoperative tamponade. EFFECT: higher efficiency. 2 dwg

Description

 The invention relates to medicine, in particular to otorhinolaryngology. It is intended for tamponade after sanitizing auditory-sparing operations on the middle ear with exacerbations of chronic purulent otitis media.

 Surgical operations on the middle ear are carried out in various modifications, the basic principle of all these operations is the removal of pathological masses from the mastoid cavity, revision of the tympanic cavity, plastic with a meatal graft, and the final stage is a dense tamponade of the postoperative cavity with gauze turunda or tampons (see Atlas of otorhinolaryngology operations / Under the editorship of Prof. V.S. Pogosov. - M .: Medicine, 1983, p. 75-98) [1].

 The disadvantage of this method of tamponade using gauze turundas or tampons is the traumatic effect on the wound. When they are removed, the leukocyte-necrotic layer, which is important for wound healing, is destroyed.

 In addition, after 4-6 hours, the gauze turns into a “cork”, completely losing the drainage function, and prevents the outflow of wound discharge.

 All of the above has a negative effect on the healing process of the wound and, thereby, lengthens the treatment time.

 There is a method of plugging the postoperative cavity in sanitizing hearing-preserving operations on the middle ear, which consists in the use of foam swabs that are sterilized and impregnated with drugs before administration (see VV Fursov. Healing of trepanation wounds of the middle ear. Abstract for the degree of doctor of m .n.- M .: 1988, p. 49-51) [2].

 The disadvantage of this method is the difficulty of introducing a tampon through the external auditory canal, caused by its low mobility, resulting in uneven pressing of the tampon to the surface of the postoperative cavity.

 There is also known a method of postoperative tamponade during operations on the middle ear, the closest in technical essence and the number of common features, which in this regard is accepted as the closest analogue. This method includes the introduction through the removed back wall of the external auditory canal into the formed mastoid cavity of the tampon in the form of an elastic container, its laying, filling with a working fluid, which is used as foam, and the subsequent removal of the tampon during dressings (see A.A. Mironov Sanitizing hearing-preserving operations for destructive forms of chronic purulent otitis media. Abstract for the degree of candidate of medical sciences - M.: 1992, p.83-86) [3].

 The method [3] partially avoids the disadvantages inherent in the method [2], namely, to prevent pieces of foam rubber sticking to the walls of the postoperative cavity, causing inflammation and growth of pathological loose granulations around it that impede the healing process. The use of foam rubber as a working fluid, which fills an elastic container in the form of a rubber glove finger, leads to significant pressure in the tampon when inserted and removed into the mastoid cavity and, as a result, to sharp pain requiring premedication with analgesics. In addition, the rubber glove finger filled with foam rubber has low mobility, poorly changes shape, that is, is not very mobile when placed in the postoperative cavity, which leads to incomplete distribution of the tampon over the entire surface of the cavity, which in turn leads to uneven compression of the meat flap.

 From the mentioned source [3] there is also known a device for postoperative tamponade during operations on the middle ear, containing a tampon in the form of an elastic container with a working fluid in the form of foam inside. This device is closest in design and the number of common features to the declared, which is why it is accepted as the closest analogue.

 Its disadvantage is the inconvenience during operation, which consists in the inability to control the process of pressing the tampon to the surface of the postoperative cavity. The fact is that the foam rubber used as a working fluid, having certain elastic properties, does not have fluidity. This dramatically reduces the mobility of the swab.

 The problem to which the claimed device is directed is to reduce the treatment time and reduce the pain of dressings, especially in the early postoperative period, as well as to improve the quality of healing of the postoperative cavity.

 The technical result from the use of the device is to preserve the leukocyte-necrotic layer and to reduce the seeding of the postoperative cavity in the early postoperative period and to create good conditions for the outflow of the wound discharge after the operation, as well as the ability to change its shape in a mobile way, which ensures a uniform fit of the tampon over the entire surface postoperative cavity.

 The named technical result is achieved due to the fact that the device for postoperative tamponade during operations on the middle ear, containing a tampon in the form of an elastic container with a working fluid inside, according to the invention is equipped with a connecting tube and valve, and the elastic container is a balloon, the internal volume of which is 2 -5 ml, and the outer surface has a layer of impregnated drug impregnation, while the working fluid is a physiological solution.

 In medicine, it is known to use a balloon catheter to remove calculi from the bile ducts in case of postcholecystectomy syndrome in endoscopic surgery (see OM Gorbunov et al. Article in the journal "Surgery", publishing house Medicine, 6, 1996, p. 61 -63) [4]. However, with its help it is impossible to achieve the above technical result, since in the claimed device a balloon filled with physiological saline solves a completely different problem, namely, it serves to ensure uniform pressing of a meat flap with a tampon over the entire surface of the walls of the postoperative cavity. The use as a working fluid of a physiological solution having fluidity and certain viscoelastic properties, together with other essential features specified in the claims, allows to achieve the above technical result. In addition, in the event of a balloon breaking when laying or when removing a tampon, saline due to its neutral properties will not harm the patient's body. Therefore, the use of water or another liquid that does not have the properties of physiological saline as a working fluid is highly undesirable.

 The applicants have not found solutions containing a common set of essential features of the claimed device, which allows us to conclude that the claimed technical solution meets the criteria of the invention of "novelty" and "inventive step".

The claimed invention is illustrated by drawings, where:
figure 1 shows the stages of surgery on the middle ear, followed by plugging;
figure 2 shows a General view of the device for the implementation of tamponade.

 The device contains a tampon in the form of a cylinder 1, which is an elastic container made of latex and an associated connecting tube 2, at the end of which an adjustable valve 3 is installed. The outer surface of the cylinder 1 has an impregnated layer with drug-lubricating impregnation (not shown in the drawings). As a working fluid, which fills the internal volume of the elastic container, physiological saline is used.

 The essence of the claimed technical solution is as follows.

 After a sanitizing auditory-sparing operation on the middle ear, a balloon 1, previously disinfected and impregnated with an impregnated layer with medicinal additives, is introduced through the removed rear wall of the external auditory canal.

 The named balloon 1 is laid on the surface of the mastoid cavity. Then, in the cylinder 1 through the valve 3 through the tube 2 serves a physiological solution. A syringe can be used for this. The amount of the supplied working fluid should be 1.5 times the volume of the mastoid cavity, which usually ranges from 2 to 5 ml, due to individual characteristics of the person. The increased pressure of the mastoid cavity created at the same time allows the tampon to be pressed against the surgical wound and the wound can be removed. Next, part of the physiological solution is removed from the cylinder 1, leaving in it such an amount of physiological solution that corresponds to the individual volume of the mastoid cavity. The valve 3 is closed and the swab is left until the next dressing, which is usually done after 2-3 days. When removing the swab, open valve 3, and half of the physiological saline, that is, 0.5 part, is removed from the cylinder 1. This allows you to reduce the pain when removing the swab. Subsequently, tamponade is produced in the same sequence until the postoperative cavity is completely healed.

 The device is illustrated by the following specific examples of its use.

Example 1
Patient K., 30 years old, medical history 45515. Clinical diagnosis: exacerbation of left-sided chronic purulent otitis media. He entered the ENT department on 11/16/98. Upon receipt of a complaint of suppuration from the ear, pain in the ear, hearing loss. Considers himself ill from the age of three. Exacerbations 1-2 times a year. The last aggravation has been worrying since 09/30/98. Objectively: the left ear - the mastoid process is not changed, its palpation is painless, the external auditory meatus is wide, there is detachable in the amount of 1-2 padded jackets, the eardrum is cloudy, hyperemic, there is perforation in the posterior sections. Radiological: there is a carious process in the attic-antral region of the left temporal bone. Audiologically: conductive hearing loss of 1-2 degrees with the phenomena of secondary cochlear neuritis.

 11/19/98 under anesthesia, a sanitizing auditory-sparing operation on the left ear was performed. Postoperative tamponade produced by a latex bulk swab, consisting of 1 - bulk balloon for tamponade of the postoperative middle ear cavity; 2 - part of the balloon for tamponade of the postoperative middle ear cavity; 3 - connecting device; 4 - valve device. Part of the balloon for tamponade, in an unfilled condition, was inserted into the postoperative cavity through the external auditory meatus, the behind-the-ear wound was sutured, and then the balloon was filled with 3 ml of physiological saline.

 The balloon was removed on day 2 without sedation. Next, a daily tamponade was carried out with a bulk latex balloon. On the 10th day, a clean postoperative cavity with smooth granulations was noted. The epidermisation of the mastodial cavity was completed on the 30th day, suppuration ceased. Thus, in comparison with the average healing period of 40 days, a quite satisfactory and high-quality period of 30 days has been achieved.

Example 2
Patient L., 16 years old, medical history 46344. Clinical diagnosis: exacerbation of right-sided chronic purulent otitis media. He entered the ENT department on November 16, 1998. Upon receipt of a complaint about periodic discharge from the right ear, hearing loss in this ear. The above complaints worry for 6 months after acute respiratory viral infections, was treated on an outpatient basis without effect.

 Objectively: the right ear - palpation of the tragus, the behind-the-ear area is painless, the external auditory meatus is wide, hyperemic, there is a purulent discharge. The tympanic membrane is muddy, without identification marks, there is perforation in the upper anterior section. Radiological: there is a blackout in the attic-antral region on the right. Audiologically: mixed hearing loss of 2 degrees with a predominance of the conductive component on the right. Bone-air gap 16 dB.

 11/30/98, under anesthesia, an operation was performed on the right ear using a latex balloon as a tamponade. Introduced 2.5 ml of physiological saline. The balloon was removed 3 days after surgery. On the 9th day, a cleansing of the cavity was noted, the epidermis was completed on the 28th day.

Example 3
Patient M., 46 years old, medical history 6730. Clinical diagnosis: chronic left-sided purulent epimesotympanitis. He entered the ENT department on March 14, 2000. Upon receipt of a complaint about periodic suppuration from the left ear, hearing loss in the left ear. Sick for 15 years, was treated on an outpatient basis, enrolled in a planned operation.

 Objectively: the left ear - the behind-the-ear area is not changed, it is painless. The external auditory meatus is wide, there is a mucopurulent discharge in the amount of 3 quilted jackets. Subtotal perforation of the eardrum. Radiological: bone-destructive process in the attic-antral region of the left temporal bone. Audiologically: conductive hearing loss of 1-2 degrees with the phenomena of secondary cochlear neuritis. On March 16, 2000, under anesthesia, an operation was performed on the left ear using a latex tampon in bulk as a postoperative tampon, which was removed on the 3rd day. On the 8th day, a cleansing of the cavity was noted, on the 25th day, complete epidermization was completed. The result of treatment can be recognized as quite satisfactory, fast and of high quality.

 In total, 17 patients have been operated on with this device for tamponade so far. Practice has shown that the developed device for tamponade can significantly reduce treatment time by an average of 30 days; reduce the morbidity and pain during the first dressings; improve the outflow of wound discharge. A significant reduction in the duration of treatment, trauma and pain was revealed.

Claims (1)

 Device for surgical tamponade during operations on the middle ear, containing a tampon in the form of an elastic container with a working fluid inside, a connecting tube and a valve, characterized in that the elastic container is a latex balloon with an internal volume of 2-5 ml, filled with saline solution, the outer surface which has a layer of drug lubricating impregnation, and the valve through the connecting tube is directly connected to the internal volume of the elastic container, made with the possibility of placement on the surface of the mastoid cavity.

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