WO2021029778A1

WO2021029778A1 - Orthopaedic device for postoperative treatment of parotid gland

Info

Publication number: WO2021029778A1
Application number: PCT/PL2020/000067
Authority: WO
Inventors: Tadeusz KAŁCZYŃSKI; Tomasz KARCZEWSKI
Original assignee: Kalczynski Tadeusz; Karczewski Tomasz
Priority date: 2019-08-09
Filing date: 2020-08-04
Publication date: 2021-02-18
Also published as: PL430848A1; PL239619B1

Abstract

The orthopaedic device is in the shape similar to music headphones, in which the band has the form of an arched headband (1) placed over the patient's head. At least one end of the headband (1) is fitted with a pressure module (2) in the shape similar to the earpad of music headphones, while the pressure module (2), when viewed from its rear side, has at least an outer casing (5) fitted on the headband (1) and a flexible cushion (6) placed in a pressure pad (7), which, in turn, has a circumferential wall comprising the flexible cushion (6) and has a bottom wall circumferentially supported on this circumferential wall. The bottom wall of the pressure pad (7) is flat on the inside and supported by the flexible cushion (6), while on the outside the bottom wall is stepped and has a thin part for supporting on the postoperative dressing of the parotid gland and a thick part with a lower cut-out for supporting in the retromandibular and submandibular spaces thus, the bottom wall of the pressure pad (7) is shaped from the outside to match the shape of the surface part of the patient's face in the area of parotid gland, including the retromandibular and submandibular spaces. The pressure module (2) has a circumferential cut-out (8) for the patient's ear while the outline of the circumferential cut-out (8) of the pressure module (2) is perpendicular to the outline of the bottom cut-out of the thick part of the pressure pad (7) of this pressure module (2).

Description

Orthopaedic device for postoperative treatment of parotid gland

The subject of the invention is an orthopaedic device for postoperative treatment of parotid gland.

Postoperative treatment of parotid gland is, for example, described in the publication: Pawel Szwedowicz, Ewa Osuch-Wojcikiewicz, Antoni

Bruzgielewicz, Piotr Chqcmski, Jagna Nyckowska, „Powiklania leczenia chirurgicznego gruczolaka wielopostaciowego slinianki przyusznej / Complications of parotid surgery for pleomorphic adenomas^'”, Otolaryngology Polska, Vol. 65, No. 5a, September 2011, p. 46 - 52.

There are known tourniquets made of gauze, bandages and similar textile materials, which are applied onto the postoperative dressing and fixed by wrapping around the head and neck. These tourniquets make it difficult for the patient to breathe and swallow and give the impression of suffocation and anxiety, and also make it difficult to replace the affected dressing. Uneven pressure, caused by the stretching of textile materials, affects the effectiveness of postoperative treatment.

Tourniquets having a similar function are known, for example, from the publication of the specifications of Chinese utility models CN201328936Y, CN203107431U and CN204542485U.

An orthopaedic device for postoperative treatment of parotid gland, according to the invention, is characterized by the fact that it is in the shape similar to music headphones, in which the band has the form of an arched headband placed over the patient's head and at least one end of the headband is fitted with a pressure module in the shape similar to the earpad of music headphones, with the pressure module, when viewed from its rear side, having at least an outer casing fitted on the headband and a flexible cushion placed in a pressure pad, which, in turn, has a circumferential wall comprising the flexible cushion and has a bottom wall circumferentially supported on the circumferential wall, in addition, the bottom wall of the pressure pad is flat on the inside and supported by the flexible cushion, while on the outside the bottom wall is stepped and has a thin part for supporting on the postoperative dressing of the parotid gland and a thick part with a lower cut-out for supporting in the retromandibular and submandibular spaces, thus, the bottom wall of the pressure pad is shaped from the outside to match the shape of the surface part of the patient's face in the area of parotid gland, including the retromandibular and submandibular spaces.

Preferably, the pressure module and its parts have a circumferential cut-out for the patient's ear, whereby the outline of the circumferential cut-out of the pressure module is perpendicular to the outline of the bottom cut-out of the thick part of the pressure pad of this pressure module.

Further benefits are obtained if the headband of the orthopaedic device placed over the patient's head has an upper grip with a rotating clamp, while sliding rigid rails, preferably each in the form of two round and parallel rods, are placed in the headband and locked in the working position with the rotating clamp.

Further benefits are obtained if the orthopaedic device has a pressure module hanger, attached to one end of the headband and joined with the outer casing of the pressure module with an articulated joint with at least two degrees of freedom.

Further benefits are obtained if the flexible cushion of the pressure module of the orthopaedic device is in the form of an inner tube filled with compressed air, and its pressure module has a working chamber inside the outer casing, which is covered by a cover firmly seated on the circumference of the outer casing, and in addition, the pressure module has a fastening ring, which is circumferentially attached to the cover of the pressure module casing by means of rivets, whereby the pressure pad being positioned circumferentially between the cover and the fastening ring while the air pressure control system of the flexible cushion is located in the working chamber of the pressure module.

The benefits in terms of increased functionality and usability of the orthopaedic device are achieved if its headband and pressure module have flexible pads made of sponge coated with air-permeable anti-allergic material, and its pressure module has a disposable sterile cover that covers the pressure pad and the lower flexible pad of this pressure module against the patient's face, while a length-adjustable flexible rear band is attached at the ends of its headband, and at the end of its headband, which is opposite to the position of the pressure module, a transverse pressure bracket is attached for supporting this headband on the other side of the head above the patient's ear, and the orthopaedic device has a pressure module stabilizer, which is in the form of a rail in the shape of a flat bar that slides out of the headband and locks the pressure module at a pre-set angle to the surface of the patient's face in the parotid gland area.

Thanks to the new design of the orthopaedic device according to the invention, its functionality is increased, thus increasing the effectiveness of postoperative treatment of parotid gland. Such orthopaedic device is designed for conservative postoperative treatment of parotid gland. Moreover, the pressure module is made in a shape reflecting the shape of the part of the face where the parotid gland is present, taking into account the retromandibular and submandibular spaces, thanks to which the pressure module applies an even pressure on the whole surface of the postoperative field.

On the pressure side, the pressure module has a shape that provides pressure perpendicular to the surface of the parotid gland and, on the other side, a recess reflecting the shape of this parotid gland, in which the flexible cushion is placed, filled with compressed air, by means of which the pressure of the pressure pad made of a flexible material and adhering directly to the postoperative field is adjusted. On the opposite side, the flexible cushion is supported on a rigid cover, which is placed on the outer casing of the pressure module, which in turn is swinging against a headband made of flexible material with rigid rails and locked in a pre-set position with a stabilizer, so that the pressure module at a given air pressure in the flexible cushion is directed towards the postoperative field and is not deflected from the pre-set direction. For protection and comfort of the patient, flexible pads made from a sponge coated with anti-allergic material are provided around the pressure module and under the patient's headband, while the pressure module on the face side is covered with a disposable anti-allergic sterile cover. The rear band used ensures the comfort of the patient's sleep by preventing the clamp of the orthopaedic device from slipping off the patient's head while sleeping. The disposable sterile cover, on the other hand, is designed to be replaced each time a dressing is changed. The pressure module is replaceable, either to adapt to the patient's right or left ear, or to adapt to the face shape of an individual patient.

The pressure foot can be made as a casted or moulded piece and, at the pressure side, has a shape that provides pressure perpendicular to the surface of the parotid gland, whereas at the internal side it has a recess reflecting the shape of the parotid gland, which in turn can be filled with air, liquid or a solid by means of which the pressure of the pressure foot directly adhering to the postoperative field is adjusted. It has a recess on the inside reflecting the shape of the parotid gland, in which the flexible cushion is placed, which in turn can be filled with air, liquid or solid body, by means of which the pressure of the pressure pad directly adhering to the postoperative field is adjusted. The flexible cushion filled, for example, with air, is locked at the other side by a cover in the form of a rigid plate made of thermoplastic or steel and is locked by a deflection stabilizer of the pressure module, while the stabilizer is made, for example, of very flexible, rigid carbon fibre or steel, so that the pressure module at a given force (pressure) does not deflect and is directed towards the postoperative field. The stabilizer is placed in a rigid, adjustable headband. Around the pressure module and headband there are pads made of a layer of anti-allergic sponge coated with air-permeable anti-allergic material.

Thanks to the designed shape of the pressure module we achieve maximum effectiveness of postoperative treatment while ensuring the user's comfort by eliminating unwanted side effects that may appear after the operation as early complications, such as: facial nerve paresis, postoperative bleeding (haematoma), infection, skin flap necrosis, fistula/saliva filled cyst (which is considered to be any fluid retention in the postoperative cavity), otitis externa, trismus, sensory loss of an auricle and surrounding area and late complications such as: Frey syndrome (sweating, lacrimation leading to loss of vision), keloid, recurrent tumour, facial contour deformity. In addition, the orthopaedic device does not cause difficulties in breathing, swallowing, sleeping, does not restrict the mobility of the head and neck and provides a comfortable change of dressing.

Technical features and advantages distinguishing the orthopaedic device according to the invention from known solutions are summarized below:

- limitation of pressing the parotid gland to the surface of a postoperative field by using a pressure module;

- controlled adjustment of the pressure exerted by the pressure module to the value required and determined by a medical doctor;

- limitation of the pressure zone to a selected area;

- absence of pressure on facial elements outside the defined postoperative field zone;

- its pressure module is replaceable and detachable with the headband, which makes it possible to adjust its size and shape to individual physiological characteristics of a patient;

- the orthopaedic device has a control system to adjust the pressure (pressure) on the postoperative dressing, which eliminates the possibility of exceeding the pressure value specified and selected by a medical practitioner; in the case of pressure reduction, an alarm is activated; moreover, there is an emergency manual pressure control in the case of damage to the electronic system;

- its headband is made of hard, physiologically neutral materials, it has only two support points on the head, but provides complete stability and comfort; it has adjustable length of the left and right side;

- in order to ensure required full sterility, a disposable latex sterile cover is used in an aseptic packaging, which is placed on the pressure module, for contact with the postoperative dressing;

- thanks to the use of special materials such as latex, the pressure module adapts in shape to the uneven postoperative surface, allowing for different thicknesses of postoperative dressing with uniform pressure over the entire surface;

- easy removal of the orthopaedic device, easy access and comfortable change of a postoperative dressing;

- the orthopaedic device does not create any pressure on the head and neck outside the post-operative field;

- limiting the pressure to certain values, adjusted by a medical doctor;

- the orthopaedic device does not press on the neck or interfere with hearing or swallowing;

- in the orthopaedic device, according to the invention, it is possible to manually inflate the flexible cushion through a non-retum valve;

- the pressure module and the headband of the orthopaedic device are joined together detachably, modularly and are equipped with an articulated joint for setting the pressure module against the postoperative field, depending on the needs on the left or right side of the face, and in addition, different sizes of pressure module are used in the device.

The object of the invention is explained in more detail in an exemplary embodiment, which does not limit the scope of protection of the invention, in the drawing, in which Fig. 1 shows an axonometric projection of the orthopaedic device according to the invention, against the background of the patient’s head;

Fig. 2 - an exploded front axonometric projection of the pressure module with a hanger; Fig. 3, 4 and 5 show respectively a rear, side and front view of the outer casing of the pressure module with a hanger; Fig. 6 shows an enlarged longitudinal section of the pressure module; Fig. 7, 8 and 9 show respectively a front axonometric view, cross-section along line A-A as shown in Fig. 9 and a front view of the cover of the pressure module; Fig. 10 and 11 - respectively a front and rear axonometric projection of the flexible cushion of the pressure module; Fig. 12 and 13 - respectively a front and rear axonometric projection of the pressure pad of the pressure module; Fig. 14, 15 and 16 - respectively a front axonometric projection, longitudinal section and a front view of the fastening ring of the pressure module; while Fig. 17, 18 and 19 - axonometric projections of the orthopaedic device according to the invention, on the background of the patient's head, respectively from the right, front and left side.

In the preferred embodiment, the orthopaedic device for postoperative treatment of parotid gland, according to the invention, is in the shape similar to music headphones, in which the band has the form of an arched headband 1 placed over the patient's head and one end of the headband 1 is fitted with a pressure module 2 in the shape similar to the earpad of music headphones. At the ends of the headband 1 of the orthopaedic device, there is an flexible rear band 3 with holes to adjust its length. At the end of the headband 1, opposite to the position of the pressure module 2, a transverse pressure bracket 4 is attached for supporting this headband 1 on the other side of the head above the patient's ear. In turn, the pressure module 2, when viewed from its rear side, has an outer casing 5 fitted on the headband 1 and a flexible cushion 6 placed in a pressure pad 7, which, in turn, has a circumferential wall comprising the flexible cushion 6 and has a bottom wall circumferentially supported on the circumferential wall. The bottom wall of the pressure pad 7 is flat on the inside and supported by the flexible cushion 6, while on the outside the bottom wall is stepped and has a thin part for supporting on the postoperative dressing of the parotid gland and a thick part for supporting in the retromandibular and submandibular spaces, thus, the bottom wall of the pressure pad 7 is shaped from the outside to match the shape of the surface part of the patient's face in the area of parotid gland, including the retromandibular and submandibular spaces.

In addition, the pressure module 2 and all its parts have a circumferential cut-out 8 for the patient's ear, whereby the outline of the circumferential cut-out 8 of the pressure module 2 is perpendicular to the outline of the bottom cut-out of the thick part of the pressure pad 7 of this pressure module 2.

The headband 1 has an upper grip 9 with a rotating clamp 10, while sliding rigid rails 11, each in the form of two round and parallel rods, are placed in the headband 1 and locked in the working position with the rotating clamp 10. In addition, the orthopaedic device has a hanger 12 of the pressure module 2, attached to one end of the headband 1 and joined with the outer casing 5 of the pressure module 2 with an articulated joint 13 with three degrees of freedom.

The flexible cushion 6 of the pressure module 2 is in the form of an inner tube filled with compressed air, and its pressure module 2 has a working chamber 14 inside the outer casing 5, which is covered by a cover 15 firmly seated on the circumference of the outer casing 5. In addition, the pressure module 2 has a fastening ring 16, which is circumferentially attached to the cover 15 of the pressure module 2 by means of rivets 17. The pressure pad 7 is positioned circumferentially between the cover 15 and the fastening ring 16 of the pressure module 2. The air pressure control system 18 of the flexible cushion 6 is located in the working chamber 14 of the pressure module 2.

In addition, the headband 1 of the orthopaedic device has upper flexible pads 19 and its pressure module 2 has lower flexible pads 20, while both the pads 19 and 20 are made of sponge coated with air-permeable anti-allergic material. The pressure module 2 has also a disposable sterile cover 21 that covers the pressure pad 7 and the lower flexible pad 20 of this pressure module 2 against the patient's face. In turn, the compression module 2 is made of physiologically neutral materials such as latex, silicone, rubber and other synthetic polymers, including those cross-linked with reinforcing fibres. Ventilation holes are made in the outer casing 5 of the pressure module 2, while in its working chamber 14, the pressure control system 18 is located in the flexible cushion 6, whereas this pressure is electronically controlled to a preset level and the control system 18 includes an air pump, a non-return valve for manual inflation and an indicator of unwanted pressure drop, a pressure display and a release button to let out the air and thus release the pressure of the pressure module 2 to the postoperative field, when removing the orthopaedic device from the patient's head, for example to replace the parotid gland dressing.

In another embodiment, the orthopaedic device, in addition to the features of the preferred embodiment, has a stabilizer 22 of the pressure module 2, which is in the form of a rail in the shape of a flat bar that slides out of the headband 1 and locks the pressure module 2 at a pre-set angle to the surface of the patient's face in the parotid gland area.

Legend

1 - headband 13 - articulated joint

2 - pressure module 14 - working chamber

3 - rear band 15 - cover

4 - pressure bracket 16 - fastening ring

5 - outer casing 17 - rivet

6 - flexible cushion 18 - control system

7 - pressure pad 19 - upper pad

8 - circumferential cut-out 20 - lower pad

9 - upper grip 21 - sterile cover 10 - clamp 22 - stabilizer

11 - rigid rail

12 - hanger

Claims

Patent claims

1. An orthopaedic device for postoperative treatment of parotid gland, characterised in that, it is in the shape similar to music headphones, in which the band has the form of an arched headband (1) placed over the patient's head and at least one end of the headband (1) is fitted with a pressure module (2) in the shape similar to the earpad of music headphones, while the pressure module (2), when viewed from its rear side, has at least an outer casing (5) fitted on the headband (1) and a flexible cushion (6) placed in a pressure pad (7), which, in turn, has a circumferential wall comprising the flexible cushion (6) and has a bottom wall circumferentially supported on the circumferential wall, in addition, the bottom wall of the pressure pad (7) is flat on the inside and supported by the flexible cushion (6), while on the outside the bottom wall is stepped and has a thin part for supporting on the postoperative dressing of the parotid gland and a thick part with a lower cut-out for supporting in the retromandibular and submandibular spaces, thus, the bottom wall of the pressure pad (7) is shaped from the outside to match the shape of the surface part of the patient's face in the area of parotid gland, including the retromandibular and submandibular spaces.

2. The orthopaedic device as claimed in claim 1, characterised in that, the pressure module (2) and its parts have a circumferential cut-out (8) for the patient's ear.

3. The orthopaedic device as claimed in claim 2, characterised in that, the outline of the circumferential cut-out (8) of the pressure module (2) is perpendicular to the outline of the bottom cut-out of the thick part of the pressure pad (7) of this pressure module (2).

4. The orthopaedic device as claimed in claim 1, characterised in that, its headband (1) placed over the patient's head has an upper grip (9) with a rotating clamp (10), while sliding rigid rails (11), preferably each in the form of two round and parallel rods, are placed in the headband (1) and locked in the working position with the rotating clamp (10).

5. The orthopaedic device as claimed in claim 1, characterised in that, it has a hanger (12) of the pressure module (2) attached to one end of the headband (1) and joined with the outer casing (5) of the pressure module (2) with an articulated joint (13) with at least two degrees of freedom.

6. The orthopaedic device as claimed in claim 1, characterised in that, the flexible cushion (6) of the pressure module (2) is in the form of an inner tube filled with compressed air.

7. The orthopaedic device as claimed in claim 6, characterised in that, its pressure module (2) has a working chamber (14) inside the outer casing (5), which is covered by a cover (15) firmly seated on the circumference of the outer casing (5).

8. The orthopaedic device as claimed in claim 7, characterised in that, its pressure module (2) has a fastening ring (16), which is circumferentially attached to the cover (15) of the outer casing (5) of the pressure module (2) by means of rivets (17), whereby the pressure pad (7) is positioned circumferentially between the cover (15) and the fastening ring (16).

9. The orthopaedic device as claimed in claim 7 or 8, characterised in that, the air pressure control system (18) of the flexible cushion (6) is located in the working chamber (14) of the pressure module (2).

10. The orthopaedic device as claimed in claim 1, characterised in that, its headband (1) and pressure module (2) have flexible pads (19, 20) made of sponge coated with air-permeable anti-allergic material.

11. The orthopaedic device as claimed in claim 10, characterised in that, its pressure module (2) has a disposable sterile cover (21) that covers the pressure pad (7) and the lower flexible pad (20) of this pressure module (2) against the patient's face.

12. The orthopaedic device as claimed in claim 1, characterised in that, a length-adjustable flexible rear band (3) is attached at the ends of its headband (1).

13. The orthopaedic device as claimed in claim 1, characterised in that, at the end of its headband (1), which is opposite to the position of the pressure module (2), a transverse pressure bracket (4) is attached for supporting this headband (1) on the other side of the head above the patient's ear.

14. The orthopaedic device as claimed in claim 1, characterised in that, it has a stabilizer (22) of the pressure module (2), which is in the form of a rail in the shape of a flat bar that slides out of the headband (1) and locks the pressure module (2) at a pre-set angle to the surface of the patient's face in the parotid gland area.