WO2022172299A1

WO2022172299A1 - Device for nose post-treatment repair

Info

Publication number: WO2022172299A1
Application number: PCT/IT2021/000005
Authority: WO
Inventors: Federica CAMPACCI; Gastone Ciuti; Leonardo Ricotti; Claudio VICINI
Original assignee: Scuola Superiore Di Studi Universitari E Di Perfezionamento Sant'anna; Universita' Degli Studi Di Ferrara
Priority date: 2021-02-12
Filing date: 2021-02-12
Publication date: 2022-08-18

Abstract

A device for nose post-treatment repair comprises a medial portion (20) supporting the nasal septum and a lateral portion (30) contacting the turbinates of the nasal wall, wherein the medial portion (20) comprises a foil element (21) to one side of which is connected a tubular element forming an airway (22), and the lateral portion (30) comprises a tamponade body (31) associated with the medial portion (20) on the same side on which the tubular element (22) is located. The tamponade body (31) comprises within it at least one air chamber (32) provided with inflation organs (33) to modulate the pressure of the tamponade body against the turbinates of the nasal wall, and a drainage duct (34) crossing it longitudinally and representing a way for cleaning the nasal cavity, decreasing the risk of post-operative fluid stagnation and infections, by constituting not only an outflow route in resting conditions, but also a conduit for injection and absorption of substances by means of a standard syringe.

Description

DISCLOSURE OF INVENTION

TITLE

DEVICE FOR NOSE POST -TREATMENT REPAIR

TECHNICAL SECTOR

[0001] The present invention relates to the medication devices used after functional nose surgery, and more specifically to those devices, which integrate a portion having a function of supporting the nasal septum and a portion having a function of plugging surgical wounds and draining postoperative fluids. The invention also relates to a method for making a device as outlined above. STATE OF THE ART

[0002] Nasal obstruction is defined as a condition of insufficient airflow through the nose, the organ that represents the initial tract of the airways.

[0003] The main structures within the nasal cavity are:

- the nasal septum, which is a vertical cartilaginous and bony structure that divides the nose into two chambers;

- the turbinates, three units (inferior, middle and superior) located on the lateral wall of both nasal cavities, whose function is to increase the available mucosal surface and improve the air humidification process thanks to the rich microcirculatory system inside them.

[0004] Both nasal cavities flow posteriorly into chambers known as choanae and then rejoin the nasopharynx.

[0005] Air chambers paired two by two and known as paranasal sinuses surround each nasal cavity: maxillary, ethmoidal, frontal and sphenoidal, depending on the cranial bone that houses them.

[0006] Due to trauma or congenital and/or pathological conditions, the structures described above may undergo anatomical and/or physiological dysfunction leading to a situation of nasal obstruction, whereby the respiratory function of the organ is compromised. [0007] When non-invasive treatments such as medication (antihistamines, antibiotics) or nasal washes do not prove sufficient to resolve a nasal obstruction, surgical methods must be used. The major nose surgeries are as follows:

Septoplasty: surgical operation to restore the nasal septum after a deviation of the latter;

- Surgery to reduce the turbinate(s): for this purpose, various techniques are used involving the mucous membrane of the turbinate (partial or total turbinectomy), or the structures below the epithelium, such as the vascular network or the supporting bone horn (turbinoplasty);

Rhinoseplasty and functional rhinoplasty: surgical techniques in which not only the cartilage portion is involved, but also the bony framework of the nose;

FESS - 'Functional Endoscopic Sinus Surgery': functional endoscopic sinus surgery to restore proper drainage of mucus into the nasal cavity.

[0008] The operations described can be performed alone or in combination in one surgical procedure. At the end of the procedure, the surgeon usually inserts a medical device into the nasal cavity for two main purposes: to support the nasal septum after a septoplasty or rhinoplasty to prevent malposition of the structure during the hospitalisation period, and to tamponade surgical wounds, mostly in the area of the turbinates, after a reduction operation or FESS, so that they do not swell and bleed post-surgery. This process is called nasal tamponade. At present, a variety of devices of different shapes, sizes, materials and suture techniques are available to enable adequate post-surgical healing. Nevertheless, a number of complications are associated with their use. Among these, as previously mentioned, we mainly report the pain felt by the patient during the permanence of the device inside the nasal cavity, the risk of haematomas and perforations of the septum due to the excessive force, autonomous and not modifiable from the outside, applied to the tissues for the tamponade of the surgical wounds; furthermore, the pressure applied indiscriminately on the whole lateral wall of the nose causes headaches and lacrimation. The use of a device that completely obstructs the nasal cavity can also lead to sleep apnoea and respiratory crises. Finally, a lack of drainage of the nasal chamber leads to an accumulation of postoperative fluids and residues, which can cause further inflammation and infection in the proximity of the surgical wounds. More importantly, it can cause high pressure in the cavity, so that the removal of the device at the end of the postoperative course is difficult for the surgeon and painful for the patient.

[0009] Among the devices most commonly used after nose surgery are the traditional nasal splints or Doyle foils: laminar devices, on average 1 mm thick, generally made of thermoplastic or silicone, used only to support the septum after septal deviation repair surgery. Such devices are available in various shapes and sizes, obviously always compatible with the anatomy of the nasal cavity, with or without an airway for the patient's breathing. They are inserted into the nostril and placed in contact with the nasal septum, then generally secured with a stitch and left in place for extended periods of up to two weeks after surgery. These devices are effective in supporting the nasal septum but have no bleeding control function.

[0010] There are also nasal swabs, so referred to in the narrower sense, involving all devices that act to control postoperative bleeding, prevent septal haematomas, swelling of the mucoperichondrial flap area and displacement of cartilage. In this respect, there are many different materials available, such as surgical gauzes, with or without dressings, non-adherent gauzes and sponges, hyperabsorbent PVA (polyvinyl alcohol) sponges (e.g. Merocel, Medtronic Xomed, Jacksonville, FL), resorbable biomaterials (e.g. Nasopore, Polyganics, Groningen, the Netherlands) and other polymeric materials. Also included in this category are 'balloon' devices, with an internal air chamber that ensures that surgical wounds are cushioned by the inflation of the chamber and subsequent adherence of the device to the nasal walls. These nasal swabs are inserted into the nasal cavity at the end of procedures such as an operation to reduce hypertrophic turbinates or functional endoscopic surgery, where incisions have been made in the lateral wall of the nasal cavity, incisions that require post-operative tamponade for proper healing. They are then left in place for a few days (depending on the preference of the surgeon, the patient and the operation performed) and ultimately removed in the case of synthetic tampons, or simply reabsorbed and washed away in the case of tampons made of biodegradable material. An example of an inner tube tamponade device is outlined in the patent application published in the United Kingdom under No. GB2261819. However, the device described herein does not include a laminar component for supporting the nasal septum, with an aeration tube for patient breathing. Furthermore, the balloon is designed to fill the entire nasal cavity and apply constant pressure, which cannot be modulated during use of the device. In addition, there are no intended means of allowing drainage to clean the cavity. Finally, the materials used are typically plastic.

[0011] Devices incorporating a portion with the function of providing nasal septal support and a portion with the function of controlling post-operative bleeding are also known.

[0012] US patent no. US 5 139 510 claims a nasal packing device that simultaneously allows support of the septum after surgery, stops nasal epistaxis and ensures correct breathing thanks to the combination of three features. Specifically, it comprises a laminar component inspired by traditional splints, made of flexible non-expandable material, designed to adapt to the shape of the nasal septum, an aeration channel (tubular or semi-tubular) anchored to the laminate made of the same material, and finally an elastic membrane joined to the peripheral wall of the aeration tube. After inserting the device into the nasal cavity, the membrane is inflated with air in order to stop post-operative bleeding. The recommended material for making this device is silicone. The device involves the use of a membrane present along the entire longitudinal dimension of the cavity and not localised. In addition, the device described is suitable for stopping bleeding, but not for plugging surgical wounds along the lateral wall of the nose. Additionally in this device, there is no provision for fluid drainage. Finally, the membrane of the device is not designed to follow the internal geometry of the organ.

[0013] US Patent No. US 4 606 346 likewise claims a nose packing device after surgical procedures, structured in several components: a laminar part inspired by traditional splints for supporting the nasal septum, a curved breathing tube and a balloon that is inflated to apply the correct pressure to the tissues of the nasal cavity. In this way, the patient's correct breathing is ensured while a controlled and defined tamponade is applied. This device also incorporates drainage means for cleaning the nasal cavity and the inflatable balloon fills the entire length of the nose. In addition, the entire device is made of plastic.

SUMMARY OF THE INVENTION [0014] Purpose of the present invention is to propose a nose post-treatment repair device, which overcomes the above limitations of the devices of known technique.

[0015] A further purpose of the present invention is to propose a nose post-treatment repair device that incorporates a nasal septal support portion and a tamponade portion that also allows for drainage of fluids that may accumulate in the nose cavity.

[0016] It is also purpose of the present invention to propose a nose post-treatment repair device, which has a tampon portion enabling to modulate the pressure exerted on the nasal walls also in a differentiated manner between the various anatomical parts concerned.

[0017] A further purpose of the present invention is to propose a nose post-treatment repair device capable of relieving the patient's pain during the post-operative recovery and more remarkably during removal of the device.

[0018] The same and further purposes are achieved by means of a post-treatment nose repair device comprising a medial portion supporting the nasal septum and a lateral portion in contact with the turbinates of the nasal wall. The medial portion comprises a semi-elliptical foil element to one side of which is connected a tubular element forming an airway, with the foil element and the tubular element made of a polymeric material such as polysiloxanes, polyurethane rubbers or fluoroplastics. The lateral portion comprises a tamponade body of elastomeric material associated with the medial portion on the same side on which the tubular element is located, with said plugging body having a trapezoidal cross-section and comprising within itself at least one inner tube provided with inflation ducts and at least one drainage duct running longitudinally through said tamponade body.

[0019] The device of the above-described invention overcomes the limitations of devices of known technique by having a medial portion that provides proper support for the nasal septum and a lateral portion that allows for non-occlusive tamponing of the surgically treated structures. This is due to the presence of the drainage duct and the ability to apply calibrated pressure on the turbinates through presence of the air chamber.

BRIEF DESCRIPTION OF THE DRAWINGS [0020] These and other features and advantages of the invention will be clearly understood from the following description, which is provided by way of example but not limited to, with reference to the accompanying drawings, in which:

- FIG. 1 shows four canonical views of a first embodiment of a device according to the present invention: FIG. 1a shows a side view with dashed lines showing non-visible parts of the device, FIG: 1b shows a bottom view, FIG. 1c shows a rear view and FIG: 1d shows a front view;

FIG. 2 shows a cross-sectional view of the device of FIG. 1 along the sectional line ll-ll of FIG. 1a;

FIG. 3 shows a perspective view of the device of FIG. 1 ;

- FIG. 4 shows the device of FIG. 1 applied to the nasal cavities in two different configurations of use: FIG. 4a shows the device in a pressure regulating configuration in an air chamber of the device, FIG. 4b shows the device in a cleansing configuration through a drainage duct of the device;

- FIG. 5 shows the steps of a manufacturing process of a device according to the present invention;

FIG. 6 shows a side view of a second embodiment of a device according to the invention in which non-visible parts are shown with dotted line.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0021] With reference to FIGS. 1 to 3, a nose post-treatment repair device according to the present invention, indicated overall by 10, comprises a medial portion, 20, supporting the nasal septum and a lateral portion, 30, contacting the turbinates of the nasal wall.

[0022] The medial portion 20 comprises a foil element, 21 , of semi-elliptical shape in accordance with the anatomy of the nasal cavity to one side of which is connected a tubular element constituting an airway, 22, i.e., a passageway with semi-circular section and curved tubular configuration to ensure natural breathing of the patient during use of the device, for prevention of hypoxic conditions and sleep disorders. The airway 22 extends longitudinally along almost the entire length of the major axis of the foil element 21. A transverse hole, 23, is provided in the anterior portion of the foil element 21 for fixing the device to the septum using sutures. The medial portion 20 is made of materials that provide rigidity for proper support of the nasal septum, but also flexibility for easy insertion of the device 10 within the nasal cavity. In view of the above, the medial portion 20 is preferably made of a first polymeric material having a flexural elastic modulus between 0.3 and 1.5 MPa, advantageously close to 0.75 MPa. Polymers with these characteristics may for example be polysiloxanes (silicones, e.g. PDMS), polyurethane rubbers, fluoroplastics. [0023] The lateral portion 30 comprises a tamponade body, 31 , associated with the medial portion 20 on the same side on which the tubular element 22 is located. The tamponade body 31 has a trapezoidal cross-section and comprises within it an air chamber, 32, of variable cross-section and provided with inflating organs, 33, designed to exert localised contact pressure at the level of the structures involved during the surgical procedure. A drainage duct, 34, runs longitudinally through the tamponade body 31 to allow natural drainage of post-surgical debris from within the cavity, and offers the possibility of introducing local medicinal therapies or fluids for flushing the nostril, or manually removing debris through it.

[0024] The tamponade body 31 is made of a second elastomeric material in order to ensure the possibility of expansion of the air chamber 32, good adaptability of shape within the cavity and painlessness especially in the anterior part, in correspondence with anatomical structures not involved in the plugging. A second elastomeric material for making the tamponade body 31 preferably has a compressive elastic modulus between 0.1 MPa and 0.3 MPa, advantageously around 0.17 MPa. Furthermore, the combination of the material of the medial portion 20 and the material of the tamponade body 31 is such that the two components perfectly integrate during the manufacturing process, avoiding that the two medial and lateral portions separate during the use of the device. The lateral portion 30 has a shorter longitudinal extension than the medial portion 20 and thus leaves the anterior and the posterior extremities of the medial portion 20 uncovered.

[0025] The air chamber 32 comprises a cavity within the tamponade body 31. Such cavity allows the device to be more adaptable to the anatomical geometry and to apply controlled and adjustable pressure to the surgical wounds throughout the patient's recovery period to prevent common complications such as haematomas or septal perforations due to excessive pressure applied to the internal structures of the nose. The air chamber 32 has a geometry such as to allow maximum use of the space available inside the tamponade body 31 , and to realise walls of the air chamber 32 of uniform longitudinal thickness, in order to ensure homogeneous inflation. The inflating organs 33 consist of a small silicone tube connected to the air chamber 32 and protruding from the front wall of the tamponade body 31, with the inflating organs 33 provided at their relative end with a valve, 35 (visible in FIG. 4), for maintaining the pressure inside the air chamber 32.

[0026] Advantageously, device 10 is entirely coated with non-stick material (fatty substances e.g. medical and non-medical ointments, or Vaseline) to prevent damage to the mucosa during the post-treatment course and to further facilitate removal of the device.

[0027] The drainage duct 34 longitudinally crosses the tamponade body 31 and flows anteriorly at the front end of the medial portion and posteriorly at the rear end of the medial portion 20 itself, allowing the outflow of liquids and residues from inside the nasal cavity to the outside simply by means of gravity. The drainage duct 34 has a variable circular cross-section with a front portion having a smaller diameter than a rear portion. In other embodiments, the drainage duct 34 has a constant cross section. The drainage duct 34 is advantageously provided with a reinforcing wall, 36, made of the same material as the medial portion 20. Such reinforcing wall 36 shows a thickness of a few tenths of a millimetre or in any case sufficient to ensure that the drainage duct 34 remains open and does not collapse following inflation of the air chamber 32. In order to improve drainage capacity and avoid possible blood clots within the drainage duct 34 that might block its function, coating the drainage duct 34 with anticoagulant and thinning factors is advantageously envisaged.

[0028] With reference to FIG. 4a, the use of the device 10 involves that after its insertion inside the nasal cavities at the end of the surgical procedure, the air chamber 32 is inflated by the physician to tamponade the wounds using an appropriate pressure, which plugs but at the same time does not cause pain to the patient, and which can be modified overtime, in the post-operative course, to dynamically adapt to the needs of the patient. This operation is possible thanks to the inflating organs 33 at the end of which the valve 35 is located. The catheter-valve system outside the nasal cavity can be secured to the patient's face (e.g. cheek or forehead). The valve system must be safe and minimally invasive for the patient, and therefore consists of, for example, a simple on/off clamp commonly used in medical drug delivery instruments, or a two- or three-way valve. It is also possible to integrate the catheter-valve system with an air pressure control inside the chamber by means of a sensor.

[0029] With reference to FIG. 4b, the use of the drainage duct 34 is shown. Indeed, in the event that the drainage duct 34 is blocked or it is necessary to locally introduce a fluid substance, such as a medicine or a nasal washing solution, a standard syringe can be used for the introduction and aspiration of material through the duct. In addition, the aspect that the lateral portion 30 leaves uncovered portions of the front and rear extremities the medial portion 30 allows for the accumulation of debris within the cavity and the collection of runoff material through the drainage duct 34, preventing it from obstructing the airway 22 and thus ensuring proper breathing at all times.

[0030] Possible variants of a device according to the present invention, which maintain its advantages and functional characteristics, relate to modifications in the size of the device aimed at improving the adherence with respect to the patient's anatomy and at enabling to treat, for example, also paediatric cases. Additionally, it is possible to model the design of the device (e.g. longitudinal profile of the medial part, position of the air chamber) on 3D reconstructions of the subject's nasal cavity from CT or MRI images, and thus create a specific device for the patient under treatment.

[0031] With reference to FIG. 6, a particularly advantageous embodiment of a device, 10', according to the present invention entails integrating within the tamponade body, 31', two air chambers, 32'a and 32'b. The air chambers 32’a and 32’b are arranged in succession in the longitudinal direction and their inflation is controlled independently of each other, so that the device can be positioned in a more versatile manner at different depths along the longitudinal axis of the patient's nasal cavity, based on the surgeon's choice and the patient's anatomy. Such a configuration guarantees maximum plugging efficacy, using either or both chambers by varying the internal pressure according to the needs of the surgical wounds and the patient. [0032] The device of the present invention can be manufactured by various techniques. These include a casting procedure using a series of moulds, injection-moulding techniques and direct moulding using a 3D printer.

[0033] A peculiar process for making the device according to the present invention provides a casting technique comprising two sequential polymerization steps in the relevant moulds. In particular, the process requires a first polymerization step in which the medial portion 20 is made in a first mould by polymerizing a first polymer and a second step in which the moulded medial portion 20 is integrated in a second mould for making the lateral portion 30 in which a second elastomer is polymerized. The polymerisation of the first polymer is only partially performed in the first mould and only completed after transfer to the second mould and the addition of said second elastomer so that the integration between the two portions and therefore the stability of their coupling is ensured. Furthermore, advantageously, with the same first polymer used for the realization of the medial portion 30 the reinforcing wall 36 of the drainage duct 34 is also realized, with a thickness of a few tenths of a millimetre. For the realization of the air chamber 32 it is first necessary to create a mould core (i.e. a cavity part) of sacrificial material that can be easily dissolved in water or another substance that is not corrosive to the elastomer (e.g. ethanol). Possible sacrificial materials are synthetic polymers such as PVA (polyvinyl alcohol), PEG (polyethylene glycol), or sugars (e.g. isomalt), waxes and resins. This operation can also be used to make the drainage duct 34

[0034] With reference to FIG. 5 the manufacturing process according to the moulding technique of the present invention comprises a phase I in which the medial portion 20 and the reinforcing wall 36 of the drainage duct 34 are made from a stiffer polymer having a flexural modulus of elasticity of 0.75 MPa. In a phase II, the air chamber cavity is made by soft-moulding technique. In a phase III, the previously made elements are integrated in a last mould in which the lateral portion 30 of the device is made by injection of an elastomer having a flexural elasticity modulus of about 0.17 MPa. Finally, a phase IV foresees the washing of the device for dissolving the sacrificial material constituting the air chamber 32 [0035] The timelines shown in FIG. 5 relate to prototyping the device by moulding at room temperature. Heat treatments may alternatively be performed during the polymerization phases to vary the curing time, or during the washing phase, also considering the possibility of shaking the device immersed in water to facilitate the dissolution of the sacrificial material.

[0036] Alternatively, a device according to the present invention is advantageously made by a direct 3D moulding process. Such process comprises the use of a machine, which performs at each point of the final device to be made the deposition of an appropriate material chosen from at least three distinct materials. Specifically, the materials which can be chosen include said first polymeric material for making the medial portion 20, said second elastomeric material for making the lateral portion 30 and said sacrificial material for making the air chamber 32 and other possible cavities of the lateral portion 30. The device is entirely made, layer by layer, by inserting at each point the appropriate material among those mentioned above to obtain the final structure.

[0037] A device according to the present invention as previously described, realised according to the methods thereto or with other manufacturing techniques, allows it to be used after the described nose operations, maintaining the functionalities of current techniques, such as support of the septum and tamponing of the surgically treated structures in a non-occlusive manner (guaranteeing physiological respiration by means of an airway). On the other hand, it allows overcoming complications; first amongst all, the sensation of pain of the patient during the postoperative course and in a greater manner during removal of the device. The medial portion 20, thanks to the unique shape and construction material, allows the support of the septum after an operation to correct a deviation thereof, while providing rigidity, but contextually flexibility for easy insertion of the device into the cavity. The lateral portion 30, on the other hand, thanks to the peculiarities of shape and size based on the anatomy of the nasal cavity, ensures comfort along the inner wall that is not subject to surgery, and at the same time proper plugging of surgical wounds in the treated areas after reduction surgery or sinus surgery. The airway 22 integrated in the medial portion 20 of the device allows the patient to breathe through the nose during hospitalization, warding off the risk of sleep apnoea and sleep disturbances, complications recorded with the use of some currently used techniques. The drainage duct 34 represents a means of cleaning the nasal cavity, decreasing the risk of post-operative fluid stagnation and infection, constituting not only an outflow route in resting conditions, but also a conduit for injecting and absorbing substances using a standard syringe. Finally, the air chamber 32, localised in the area of the turbinates, makes it possible to apply a specific pressure on the turbinates, adequate and adjustable during use, depending on the real need, reducing the risk of haematomas and perforations of the septum due to excessive pressure on the tissues and reducing the patient's pain.

[0038] The advantages outlined above of the previously described embodiments of a device for nose post-treatment repair according to the present invention remain upheld even in the presence of further variations. Indeed, the embodiments described and depicted are only by way of example and not limitation, so that a device according to the present invention may envisage further modifications and variants of a practical application nature, while remaining within the scope of protection provided by the following claims.

Claims

1. A device for nose post-treatment repair (10) comprising a medial portion (20) supporting the nasal septum and a lateral portion (30) in contact with the turbinates of the nasal wall, wherein said medial portion (20) comprises a foil element (21) to one side of which is connected a tubular element constituting an airway (22), and said lateral portion (30) comprises a tamponade body (31) associated with said medial portion (20) on the same side on which said tubular element (22) is located, with said tubular element (22) being connected to said medial portion (20) on the same side on which said tubular element (22) is located, said tubular element (22) with said tamponade body (31) comprising within it at least one air chamber (32) provided with inflating organs (33) characterized in that said lateral portion (30) comprises at least one drainage duct (34) longitudinally crossing said lateral portion (30).

2. Device (10) according to claim 1 characterised in that said foil element (21) has a semielliptical shape, said tubular element (22) has a semi-circular cross-section and a curved tubular configuration, said foil element (21) and said tubular element (22) are made of a first polymeric material having a flexural elasticity modulus between 0. 3 MPa to 1.5 MPa, such as polysiloxane, polyurethane rubber or fluoroplastic, said tamponade body (31) having a trapezoidal cross-section and made of a second elastomeric material having a modulus of elasticity in compression between 0.1 MPa and 0.3 MPa.

3. Device (10) according to claim 1 or 2 characterised in that said lateral portion (30) has a longitudinal extension which is smaller than said medial portion (20) and therefore leaves uncovered a portion of front end and a portion of rear end of said medial portion (20).

4. Device (10) according to any one of the preceding claims, characterised in that said air chamber (32) has a geometry such as to maximize the available space inside said tamponade body (31) and to realize walls of said air chamber (32) of uniform longitudinal thickness, said inflating organs (33) comprising a small tube connected to said air chamber (32) and exiting from the front wall of said cushioning body (31), at the end of said inflating organs (33) being present a valve (35) for maintaining the pressure inside said inner tube (32).

5. Device (10) according to one of the preceding claims, characterised in that said drainage duct (34) longitudinally crosses said tamponade body (31) and flows anteriorly in correspondence with the front end of said medial portion (20) and posteriorly in correspondence with the rear end of said medial portion (20), allowing liquids and residuals to flow from inside the nasal cavity to outside, said drainage duct (34) being provided with a reinforcing wall (36) of sufficient thickness to ensure that said drainage duct (34) remains open and does not collapse upon inflation of said air chamber (32).

6. Device (10) according to any of the preceding claims characterised in that said drainage duct (34) has a coating with anticoagulant and fluidifying factors.

7. Device (10) according to any of the preceding claims, characterised in that it comprises two air chambers (32'a and 32'b) arranged in succession in the longitudinal direction of said tamponade body (31') and the inflation of which is controlled independently of each other.