Removable intraluminal prosthesis suitable for treating various kinds of laryngeal stenosis, laryngeal paralysis and / or laryngeal collapse

Abstract

The present invention relates to a removable intraluminal prosthesis which is suitable for treating various kinds of laryngeal stenosis, laryngeal paralysis and / or laryngeal collapse, and which is available in temporary and permanent embodiments. The prosthesis is made of a single semi-circumferential part with wing-shaped openings at the cranial end and an oval anchoring hoop at the caudal end. Likewise, the part has different holes along its length depending on the embodiment. The prosthesis at least has holes in the region of the wings, to increase flexibility and enable the prothesis to be secured, and a hole in the ventral part of the caudal region of the prothesis, as a safety window in the event that the part moves.

Description

[0001] DESCRIPTION

[0002] REMOVABLE INTRALUMINAL PROSTHESIS, SUITABLE FOR THE TREATMENT OF LARYNGEAL PARALYSIS, LARYNGEAL COLLAPSE AND / OR LARYNGEAL STENOSIS OF VARIOUS NATURE

[0003] TECHNICAL SECTOR

[0004] The present invention falls within the technical field of devices for widening a stricture in a body passage. More specifically, the invention relates, without limitation, to devices for the treatment of laryngeal obstruction, particularly for the treatment of laryngeal collapse and paralysis in animals. The invention is also applicable in humans.

[0005] BACKGROUND OF THE INVENTION

[0006] Among the techniques for the surgical treatment of stenosis in a body duct, it is common to use procedures involving the placement of stents, intraluminal prostheses, or endoprostheses (in this document, both terms will be treated synonymously), typically defined as hollow cylindrical prostheses that maintain luminal patency and the dimensions of a tubular structure by resisting extrinsic compressive forces and providing internal support. Likewise, in the context of this invention, the term “intraluminal” will be used, understood as “within the lumen of any tubular structure or organ.”

[0007] The placement of intraluminal stents or prostheses is therefore a valuable procedure in surgical treatment, since, in patients with anatomical limitations, metastatic disease or poor general condition, the use of minimally invasive techniques, without the need to injure the surrounding tissue, is of great help.

[0008] Specifically, for the treatment of laryngeal collapse, there is no specific stent. Silicone stents have been used in emergency and exceptional cases, as will be discussed later. For the treatment of laryngeal collapse, there is a type of metallic stent registered in veterinary medicine, and again, in exceptional cases, a silicone stent has been used. Regarding silicone intraluminal stents or prostheses (hereafter also referred to as plastic stents), these prostheses are particularly advantageous because they are inexpensive and easy to remove. Another advantage is the low irritation they cause to adjacent tissues, as well as the low risk of intraluminal tumor growth. However, they also have disadvantages: silicone prostheses do not re-epithelialize, which impairs mucociliary function and increases mucus accumulation inside the stent.Another drawback of these plastic stents is that they are difficult to fix to the laryngeal wall, which can lead to migration. Furthermore, their completely circular shape keeps the laryngeal lumen excessively open, increasing the likelihood of swallowing obstructed. Finally, another potential disadvantage is their thicker wall, which reduces the airway lumen.

[0009] Regarding metallic stents, these are placed using a flexible bronchoscope and are used exclusively for the treatment of laryngeal paralysis. Their main advantage is that their implantation does not affect the cranial portion of the arytenoid cartilages, reducing the possibility of swallowing difficulties. However, their implantation appears to be permanent because the prosthesis re-epithelializes. Experience with this new stent is still very limited, but according to the indications for use, the laryngeal opening it provides is minimal, excluding its use in any stenosis of neoplastic or degenerative origin.

[0010] Alternatively, there are surgical options such as arytenoid lateralization or intraoral cartilage photovaporization.

[0011] Given the limitations described in the preceding paragraphs, it is necessary, in this technical field, to provide an intraluminal prosthesis for the treatment of laryngeal stenoses of various origins. More specifically, an intratracheal prosthesis is needed that:

[0012] - Avoid migration as much as possible.

[0013] - It does not require a large radial force exerted against the tissue to decrease mucosal necrosis.

[0014] - Reduce the amount of material to promote mucus removal.

[0015] - Avoid fluoroscopy and specific training for its implantation.

[0016] - Be easily and effectively removable.

[0017] - Allow for a greater margin of estimation of the appropriate size without losing other advantageous technical features.

[0018] - Allows treatment of a wider variety of laryngeal pathologies - Requires minimal surgical intervention.

[0019] - It is manufactured with materials and design that are easy to obtain and has a low cost.

[0020] To this end, the present invention proposes a removable intraluminal prosthesis designed, though not limited to, the treatment of laryngeal obstruction, the technical implementation of which overcomes the problems detailed above. The prosthesis is presented in two versions: temporary and permanent.

[0021] EXPLANATION OF THE INVENTION

[0022] An object of the present invention relates, without limitation, to the development of a removable intraluminal prosthesis, suitable for use in widening a laryngeal stenosis; comprising a main crescent-shaped piece, with wings on the cranial aspect and a semi-closed loop or ring (365° circumference) for circumferential anchoring on the caudal part (tail of the prosthesis).

[0023] To facilitate its detailed description, the laryngeal device is divided into three parts: the head, the body, and the tail. Each of these parts plays a specific role in the function and effectiveness of the prosthesis in widening laryngeal stenosis.

[0024] Temporary prosthesis: manufacturing material silicone and / or other plastic, with or without incorporation of a metal (Figures 1 AF).

[0025] The prosthesis head, which corresponds to the cranial aspect, has a crescent shape (3 / 4 of a circle) with two wings that prevent its displacement towards the caudal end. These wings also have a hole that allows them to be anchored to the athenoid cartilages if desired.

[0026] The prosthesis body is a semicircle that leaves the dorsal portion open. On its ventral side, it features an opening designed to promote mucociliary washing and reduce the risk of obstruction in case of displacement.

[0027] The tail or caudal section of the prosthesis, located in the cricoid region, is configured with an oval ring designed to anchor 365° in the airway. This ring has a slight incline in a preferred embodiment. It is worth noting that this ring is not completely closed, which facilitates its safe removal.

[0028] The main function of the prosthesis lies in opening the larynx.

[0029] The prosthesis could have variations, such as a completely straight, curved, and differently oriented ring (Figure 1A, 1C). The height of the wings can be different (Figure 1A, 1B).

[0030] The prosthesis could have variations, such as holes in its structure (Figure 1 D).

[0031] The prosthesis could have variations, such as lateral arms that anchor to the vocal cords to reduce migration (Figure 1 E)

[0032] The prosthesis could have variations, such as hooks in different orientations to reduce migration (Figure 1F)

[0033] Permanent prosthesis: manufacturing material Nitinol (Figure 2)

[0034] The permanent prosthesis has a similar morphology to the temporary prosthesis; however, its entire structure features hollow regions of varying geometries. This characteristic aims to reduce the amount of material used and promote re-epithelialization and mucociliary clearance. Structurally, three points without hollow regions are maintained: one at the cranial end, one in the middle, and one at the caudal end, to ensure optimal radial strength.

[0035] This prosthesis design is intended for permanent implantation in cases of neoplasms, external compressions, or high-grade laryngeal collapse.

[0036] In a preferred embodiment of the invention, the prosthesis has an opening for fixation to the tissue, or an adhesive to reduce migration.

[0037] In a preferred embodiment, the prosthesis has a large hole on the ventral side to allow ventilation of the animal in case of rotation of the prosthesis.

[0038] In a preferred embodiment, the permanent prosthesis has holes that distribute the radial force heterogeneously, providing greater expansion force in the medial portion.

[0039] In a preferred embodiment, the permanent prosthesis will always maintain three regions without a hole, which will be the radial core.

[0040] In a preferred embodiment, the prosthesis will be inserted into the larynx with a tubular compression system.

[0041] In a preferred embodiment, the manufacturing material used will be silicone and nitinol, without excluding other plastic, metallic, or biodegradable materials. In a preferred embodiment, the diameters range from 0.3 mm to 200 mm.

[0042] In a preferred embodiment, the length of the prosthesis may range from 5mm to 200mm.

[0043] In a preferred embodiment, the prosthesis will be applicable to veterinary and human medicine.

[0044] In a preferred embodiment, the manufacturing material will be radiopaque or will have a cranial and caudal radiopaque marker for easy radiological localization.

[0045] Another object of the invention relates to the installation kit. This comprises two parts: a compression system and the release sheath or stem.

[0046] The external geometric shape is an oval of varying diameters and a sheath on which it slides to release the prosthesis. The sheath has a hook that anchors the prosthesis to keep it in place until the desired release or repositioning.

[0047] In a preferred embodiment of the release kit, the sleeve will be made of a soft, transparent plastic material, and the stem will be rigid for better handling.

[0048] In a preferred embodiment, the stem will have a hook that holds the prosthesis together until its final release.

[0049] DESCRIPTION OF THE FIGURES

[0050] FIGURES 1: Temporary laryngeal stent modality: temporary prosthesis

[0051] Figure 1A shows a schematic of the temporary prosthesis, according to a preferred embodiment of the invention in different projections.

[0052] Figures 1 B-1 F show device variables.

[0053] FIGURE 2: Permanent laryngeal stent modality: permanent prosthesis

[0054] Figure 2 shows a schematic of the permanent prosthesis, according to a preferred embodiment of the invention. Each of the parts of the head, body, and tail is indicated. The permanent prosthesis has strategically placed holes throughout its body to maintain radial strength while allowing flexibility and mucociliary clearance.

[0055] Numerical references for the figures

[0056] PREFERRED EMBODIMENT OF THE INVENTION

[0057] An example of a preferred embodiment of the present invention is described below, provided for illustrative purposes, but not to limit it.

[0058] A principal object of the invention, as described in the preceding sections and as depicted in Figures 1A, B, C, D, E, F, and Figure 2 of this document, relates to a laryngeal stent comprising a main component (Figures 1-2) corresponding to the permanent and temporary devices. Both devices have a semi-circular tubular shape (half circumference), a cranial aspect with a wider opening (three-quarters opening), and various orifices that provide anchoring points to the arytenoid cartilages and mucociliary clearance. The central region of the temporary version has only one ventral orifice, while the permanent version, in addition to the ventral orifice, has several orifices of an abstract geometry that reduces the amount of material in contact with the mucosa.Finally, the caudal portion, in both versions of the stent, ends in a point, reducing the circumference to less than one circumference, and features an incomplete oval-shaped anchoring loop adapted to the caudal laryngeal morphology at the arytenoid opening. This loop is not completely straight, having an opening angle greater than 90°.

[0059] Alternatively, the cranial wings may have an anchoring hook. Alternatively, the cranial aspect may have a circumferential opening reduction to decrease the laryngeal opening.

[0060] Alternatively, the cranial aspect has a circumferential reinforcement.

[0061] Alternatively, the caudal ring will be of full circumference and of different width (0.2mm-2mm thread thickness). This ring can be plastic or metallic, being a filament. Alternatively, the caudal aspect of the device will not end in a point.

[0062] Temporary prosthesis: made of silicone or some other plastic material (Figure 1A-F). The head (cranial aspect) is crescent-shaped with an opening greater than one circumference, characterized by having wings on both sides that anchor to the cuneiform processes of the arytenoid cartilage and also provide a fixation point for greater security. This region leaves the glottic rim free with a physiological opening.

[0063] The body is a short semicircle, extending from the arytenoid region to the cricoid cartilage, leaving the dorsal portion free. On the ventral-caudal side, there is an opening above the semicircle to facilitate mucociliary washing and reduce the risk of obstruction should the prosthesis move ventrodorsally in the caudal direction.

[0064] The tail or caudal portion (cricoid region) consists of an oval ring for 360° anchoring in the airway. This ring is not completely closed, allowing for safe removal at any time. The oval is larger than the circumference to exert sufficient radial force and prevent movement of the device.

[0065] Permanent prosthesis: manufacturing material Nitinol or other metallic or resorbable material (Figure 2)

[0066] The geometric structure is the same as previously described in the temporary prosthesis, with the major difference being the abstract holes it has.

[0067] As can be seen in Figures 2, the entire structure has strategically placed holes to disperse the radial force and minimize the amount of material in contact with the mucosa.

[0068] Therefore, the present invention solves the technical problem posed, thus improving the state of the art, obtaining the following advantages:

[0069] It is a removable laryngeal prosthesis, available in two versions: temporary and permanent. - It is implanted using minimally invasive surgery, avoiding fluoroscopy and requiring specific training.

[0070] - Its design allows for a physiological opening of the larynx.

[0071] - Its design allows for the treatment of both laryngeal collapse and laryngeal paralysis. - It is removable because it has a full ring that permanently anchors the device to the tissue.

Claims

CLAIMS 1 Removable intraluminal prosthesis adapted for widening a stenosis in a body duct, and characterized in that it comprises: - a main portion (6) configured with an open semilunar geometry, adapted to be arranged in the stenosis of the body canal, substantially along a longitudinal axis (7), wherein said main portion (6) comprises a dorsal region corresponding with the open part of the semilunar geometry and a ventral region comprising at least one ventral orifice (3); - a cranial portion (8), adapted to be arranged at one end of the main portion (6) along the longitudinal axis (7); and - a caudal portion (5), arranged at one end of the main portion (6) along the longitudinal axis (7), opposite the cranial portion (8), wherein: the cranial portion (8) comprises two cranial wings (4) arranged oppositely along a transverse axis (9), substantially perpendicular to the longitudinal axis (7); and the caudal portion (5) comprises a caudal fixation element (1), adapted to fix the intraluminal prosthesis to the body duct. 2.- The intraluminal prosthesis according to claim 1, wherein each cranial wing (4) of the cranial portion (8) comprises at least one cranial orifice (2) and / or an adherent. 3.- The intraluminal prosthesis according to claim 1, wherein the main portion (6), the cranial portion (8), and / or the caudal portion (5) are made of a material comprising a polymer, a biodegradable material, and / or a metal alloy. 4.- The intraluminal prosthesis according to the previous claim, wherein the polymer comprises a thermoplastic and / or a silicone, and / or the metal alloy comprises nitinol. 5.- The intraluminal prosthesis according to any one of claims 1 to 4, wherein the main portion (6), the cranial portion (8) and / or the caudal portion (5) comprise a plurality of surface orifices. 6.- The intraluminal prosthesis according to any one of claims 1 to 5, wherein the caudal fixation element (1) comprises a semi-ring geometry or a ring geometry. 7.- The intraluminal prosthesis according to any one of the preceding claims 1 to 6, wherein the caudal fixation element (1) is positioned at an angle of at least 90° with respect to the longitudinal axis (7). 8.- The intraluminal prosthesis according to any one of the preceding claims 1 to 7, wherein the height of the caudal ring (1') of the piece may have a different height. 9.- The intraluminal prosthesis according to any one of the preceding claims 1 to 8, wherein the main portion (6), the cranial portion (8) and / or the caudal portion (5) comprise a plurality of anchors adapted to anchor the intraluminal prosthesis to the body duct. 10.- The intraluminal prosthesis according to the preceding claim, wherein: in the main portion (6) and / or in the caudal portion (5), the plurality of anchors comprises hooks; and / or in the cranial portion (8), the plurality of anchors comprises hooks and / or two arms arranged in a counter-opposite manner along the transverse axis (9). 11.- A placement kit adapted for placing an intraluminal prosthesis in a body canal according to any one of the preceding claims 1 to 10 comprising: a compression system; and a stem.

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