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Title:
AN INTRATYMPANIC INJECTION NEEDLE
Document Type and Number:
WIPO Patent Application WO/2020/231368
Kind Code:
A1
Abstract:
This invention relates to an intratympanic injection needle (1) which is developed for middle ear injections and an apparatus containing said needle (1). The intratympanic injection needle (1) has been developed for middle ear injections. Intratympanic injection needle (1) comprises two needles such that one is shorter than the other, the longer one of these needles carries medicine to the middle ear while the other carries the air in the middle ear to the outer environment to reduce the pressure in the middle ear.

Inventors:
CAN ERTUGRUL (TR)
Application Number:
TR2020/050320
Publication Date:
November 19, 2020
Filing Date:
April 15, 2020
Export Citation:
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Assignee:
ONDOKUZ MAYIS UNIV (TR)
International Classes:
A61F11/00; A61M5/158; A61M5/34
Foreign References:
CN2295471Y1998-10-28
CN108524100A2018-09-14
CN102397132A2012-04-04
Attorney, Agent or Firm:
SEVINC, Cenk (TR)
Download PDF:
Claims:
CLAIMS

1. An intratympanic injection needle (1 ), characterized in that; it comprises an injection needle (2) which delivers the medicine to be injected to middle ear, a discharging needle (3) which delivers the air in the middle ear to the outer environment in order to prevent pressure forming in the middle ear during injection, and a compression lock (4) for combining these needles.

2, An intratympanic injection needle (1 ) according to Claim 1 , characterized in that; the discharging needle (3) is shorter than the injection needle (2). 3, An intratympanic injection needle (1 ) according to Claim 1 , characterized in that; the sharp tips of the injection needle (2) and the discharging needle (3) are positioned side by side at the tip portion of the intratympanic injection needle (1 ).

4. An intratympanic injection needle (1 ) according to Claim 1 , characterized in that; the chamfered surfaces of the needles are positioned as facing the opposite directions so that the liquid injected via the injection needle (2) does not come out of the discharging needle (3).

5, An intratympanic injection needle (1 ) according to Claim 1 , characterized in that; it is made of stainless steel.

6. Production method of an intratympanic injection needle (1 ) according to any one of the preceding claims, characterized in that; it comprises the following process steps of

- Positioning the injection needle (2) and discharging needle (3) side by side such that their sharp tips are next to each other,

- Putting the compression lock (4) to the needles standing side by side, - Pressing the injection needle (2) and the discharging needle (3) to which the compression lock (4) is fitted such that they stand adjacent to each other by means of a press. Use of an intratympanic injection needle (1 ) in all interventions which require injection into the middle ear according to any of Claims 1 to 5.

An injection apparatus (5) containing an intratympanic injection needle (1 ) according to any of Claims 1 to 5

Description:
AN INTRATYMPANIC INJECTION NEEDLE

Technical Field

The present invention relates to an intratympanic injection needle (1 ) which is developed for middle ear injections and an apparatus containing said needle. The intratympanic injection needle (1 ) has been developed for middle ear injections.

State of the Art

Intratympanic (IT) injection treatment is a treatment method for the medical treatment of cochlear diseases, wherein the medicine is directly injected to middle ear by an injector through the ear drum. Our aim here is to ensure that the medicine developed for the ear directly reaches the middle ear unlike the oral drugs. Major cochlear diseases for which intratympanic injection treatment is applied are; sensorineural hearing losses (sudden hearing loss and autoimmune hearing loss), vertigo, neoplastic, Meniere's disease and tinnitus (ringing in ears).

Studies of applying the medicines locally to inner ear first carried out in the 50s. First applications were the local anesthetic and antibiotic administrations to the middle ear with the Meniere's Disease. In 1956, Schuknecht administered IT streptomycin on Meniere's patients. However, severe hearing losses encountered due to use of streptomycin restricted the administration of this medicine. The opinion that the local gentamicin administration eliminated the symptoms without damaging the hearing much became popular in the 90s. In 1991 , Itoh and Sakata successfully experimented IT steroid therapy in Meniere patients. Today, IT applications are among the basic treatment options for various diseases and many studies have been provided to improve this application.

The biggest advantage of intratympanic injection therapy is that the medication used for treatment does not have systemic side effects, since it is only applied to the middle ear. Cortisone, which is used especially in the treatment of sudden hearing losses, can t cause side effects that can result in fatal consequences such as stomach complaints, weight gaining and even gastric bleeding when administered orally as drug. However, since intratympanic injection therapy is effective locally, those side effects are out of question. In addition, intratympanic injection therapy is much more effective than other orally administered drugs used for both inner ear and middle ear, and recovery and processing periods are very short and positive results are obtained.

In the application of intratympanic injection, the eardrum where intratympanic injection will be applied is anaesthetized with a spray containing lidocaine. The ear which is anesthetized by spray should rest for a short time. The medicine is delivered to the middle ear by passing through the eardrum with a dental needle-tipped injector that is as thin as a hair. Since the hole in the eardrum is too small, the eardrum repairs itself immediately and no permanent hole is formed. Furthermore, the patient can easily go back to normal life shortly after the procedure is completed.

The middle ear cavity is a closed area. There is a connection between the eustachian tube and the nose, but this connection is closed when resting. With intratympanic injection, this space is completely filled with medicine (in liquid form) via injection. In the present art, dental needles are used; wherein, since the medicine is injected into the middle ear with a single needle, the pressure in the middle ear increases and therefore a mechanism is needed to discharge the air in the middle ear. This not only makes the injection difficult, but also makes the treatment more painful due to increased pressure. The patent application No EP 3 338 837 A1 in the state of the art relates to a syringe for intratympanic injection. Said intratympanic injection syringe includes a dental needle, wherein it includes a system by which the temperature change can be determined by the color change on the syringe and accordingly, injection is performed at the injection temperature. In the state of the art, patent document No JP6133464 B1 relates to an autoiogical injection needle containing a needle that allows to reduce damage to the tympanic cavity.

In the state of the art, no apparatus as solution has been developed for discharging the pressure in the middle ear during intratym panic injection; due to the above-mentioned problems and because of the inadequacy of the existing solutions, it has become necessary to make an improvement in the technical field. The present invention relates to an intratympanic injection needle which eliminates those drawbacks, and to an intratympanic injection apparatus containing this needle.

Brief Description and Aims of the Invention

The present invention discloses an innovative intratympanic injection needle developed for intratympanic injection therapy, and an apparatus containing it.

An aim of the invention is to solve the pressure problem occurring in the middle ear during intratympanic injection therapy.

Another aim of the invention is to establish a system that discharges the air in middle ear simultaneously with injection info the middle ear.

A further aim of the invention is to make intrathympanic injection therapy painless and comfortable for the patient.

Another aim of the invention is to perform an effective intratympanic injection therapy without requiring an extra process or apparatus.

Definitions of the Figures Describing the invention

In order for the embodiment of the invention and the advantages thereof together with additional components to be better understood, the below explained figures should be taken into account while making evaluation. 1 : View of the intratympanic injection needle.

2 : Exploded view of the intratympanic injection needle.

3: General view of the syringe containing the intratympanic injection needle.

Definitions of Elements/Sections/Parts Constituting the Invention In order to better describe the intratympanic injection needle and the intratympanic injection apparatus developed by this invention, the parts and sections disclosed in figures are numbered and the definition of each number are given below:

1. Intratympanic injection needle

2. Injection needle

3. Discharging needle

4. Compression lock

5. Injection apparatus

Detailed Description of the invention

The subject matter intratympanic injection needle (1 ) comprises an injection needle (2) and a discharging needle (3). The injection needle (2) delivers the medicine injected to the middle ear. The discharging needle (3) transports the air in the middle ear to the outer environment in order to balance the pressure formed as result of the injection in the middle ear. The sharp tips of the injection needle (2) and the discharging needle (3) are positioned at the tip of the intratympanic injection needle (1 ). The chamfered surfaces of the needles are positioned as facing the opposite directions so that the liquid injected with the injection needle (2) does not come out of the discharging needle

(3). The discharging needle (3), which ensures that the air in the middle ear is transported to the outer environment, is shorter compared to the injection needle (2). The reason of this is that the needle moves by bending in the ear while injection is performed. Since the injection needle (2) and discharging needle (3) combined by the compression lock

(4) will exhibit a more rigid behavior; A successful injection is achieved by performing the bending function only by the handle part of the injection needle (2).

Production method of the intraympathic injection needle (1 ) comprises the following process steps; - Positioning the injection needle (2) and discharging needle (3) side by side such that their sharp tips are next to each other,

- Putting the compression lock (4) to the needles standing side by side,

Pressing the injection needle (2) and the discharging needle (3) to which the compression lock (4) is fitted such that they stand adjacent to each other by means of a press.

The intratympathic injection needle (1 ) can be produced in accordance with the injection apparatus (5) of any size by pressing the injection needle (2) and the discharging needle (3) of different diameters by means of compression locks having different sizes.

The subject matter intratympanic injection needle (1 ) is made of stainless steel.

The intratympathic injection needle (1 ) is used in all interventions which require injection into the middle ear.

The injection apparatus containing the subject matter intratympanic injection needle (1 ) can be a syringe or an injector.