Implant, and a medical assembly for inserting such an implant into a body cavity of a human or an animal
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- DIANOSIC
- Filing Date
- 2023-07-06
- Publication Date
- 2026-05-27
Smart Images
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Abstract
Description
Technical Field
[0001] The present invention relates to a medical implant intended to be introduced into a body cavity of a human or an animal. The present invention also relates to a medical assembly comprising such an implant and a device designed for the insertion and deployment thereof into a body cavity of a human or an animal.
Background Art
[0002] More particularly, the present invention is applicable to an implant comprising at least one wall formed from an elastic structure intended to surround a biological prominence present in a cavity in order to fix the implant around the biological prominence. Such a device remains implantable and thus can always be referred to as an "implant", even if it is not intended to penetrate any biological tissue or be introduced into any biological tissue. It should also be noted that the elasticity of the structure does not necessarily correlate with the elasticity of its constituent material. In a manner known per se, it is possible to obtain a structure having elastic properties imparted by its configuration, even if the constituent material has low elasticity or very low elasticity.
[0003] Such an implant is, for example, the subject of the pamphlet of International Publication No. WO 2019 / 025695 (A1). In this document, the implant comprises at least one clip with two flat walls, which walls are intended to grip more precisely a biological prominence, in particular the middle turbinate and / or the inferior turbinate of the nasal cavity of the human body, therebetween. Each flat wall comprises an elastic wire structure element having a plurality of bending portions in order to enable the wall to contract laterally before insertion of the implant when the implant is introduced into a syringe-shaped insertion and deployment device and then to expand laterally inside the nasal cavity when exiting this syringe. Thereby, the implant can be introduced into the cavity through a narrow opening and can obtain a large lateral dimension for stable and durable fixation around the biological prominence.
[0004] However, this flat clip configuration is rather complex to manufacture industrially. Further, the mechanical retention for each of the associated biological ridges is not ideal, and thus it is advantageous to provide front and rear stabilizing devices, which further complicates the manufacturing. Further, the overall shape of the implant, which tends to apply pressure to each biological ridge grasped by the implant, is not anatomically optimal.
Prior Art Documents
Patent Documents
[0005]
Patent Document 1
Summary of the Invention
Problems to be Solved by the Invention
[0006] Therefore, it is desirable to provide a medical implant that makes it possible to overcome at least some of the above-described problems and constraints.
Means for Solving the Problems
[0007] Therefore, there is proposed a medical implant intended to be introduced into a body cavity of a human or an animal, comprising at least one wall formed from an elastic structure intended to surround a biological ridge present in the cavity for fixing around the biological ridge, the at least one wall having an essentially cylindrical shape and being formed over the entire cylindrical side surface of the implant except for at least one limiting angular portion of its outer periphery, thereby imparting radial elasticity to the cylindrical side surface of the implant.
[0008] Thus, the cylindrical shape of the implant is generally easy to manufacture industrially considering the materials used for medical purposes. Also, it is more anatomical, and in particular, when the biological protrusion in question is the middle or inferior turbinate of the nasal cavity, its radial elasticity enables it to be stably held against the surrounding anatomical walls in the deployed configuration. On the other hand, due to the wall-free limiting angle portion forming a notch or a complete opening in the direction of the axis of the cylinder, it is possible to arrange it around the protrusion by sliding along this limiting angle portion, making it more anatomical. Furthermore, due to the radial elasticity of such an implant, it is possible to accurately place the implant by means of an insertion deployment device, into which the implant can be inserted in a contracted configuration under elastic stress.
[0009] Optionally, the at least one wall is formed over the entire cylindrical side surface of the implant, except for the entire length of the at least one limiting angle portion of its outer periphery.
[0010] Also, optionally, the implant has a distal end, at which the at least one limiting angle portion is open and unrestricted for the assumed sliding engagement of the biological protrusion within the implant from its distal end, and a distal end, - a proximal end having an abutment portion, which is for restricting the assumed engagement of the biological protrusion inside the implant up to this abutment portion, and a proximal end, and comprises.
[0011] Also, optionally, the implant may comprise a plurality of elongated flanges, in particular four elongated flanges, extending from the at least one wall at the distal end of the implant and bent inwardly of the at least one wall.
[0012] Also, optionally, the implant has a plurality of extensions extending from the wall at the proximal end of the implant and shaped to form the base of the abutment portion for the biological protrusion when the biological protrusion is engaged within the implant over the entire length of the limiting angle portion, in particular, - Three extensions, one of which is oval and two of which are kidney-shaped, bent at a right angle or an angle close to a right angle with respect to the inside of the at least one wall, or - Two hook-shaped extensions, the bases of which are symmetrically arranged according to the symmetry plane of the implant centered on the limiting angle part, and the hook-shaped free ends of which intersect at the limiting angle part. The implant may comprise a plurality of extensions as described above.
[0013] Optionally, the implant may also comprise a single perforated wall of a radially elastic structure having a solid peripheral frame, and this single wall is formed over the entire cylindrical side surface of the implant except for a single limiting angle part on its outer periphery.
[0014] Optionally, the implant may also comprise a single wall of a radially elastic diamond mesh structure, and this single wall is formed over the entire cylindrical side surface of the implant except for a single limiting angle part on its outer periphery.
[0015] Optionally, the implant may also comprise two semi-cylindrical walls having a radially elastic structural element with corrugations such that the structural element is bent several times on itself, and these two walls are formed opposite to each other over the entire cylindrical side surface of the implant except for two limiting angle parts on its outer periphery that are radially opposed between these two walls.
[0016] Also, a medical assembly for introducing an implant into a cavity of a human or animal body, - A medical implant according to the present invention, and - A device for inserting and deploying the medical implant into a cavity of a human or animal body, comprising The insertion and deployment device comprises a chamber for receiving the implant and radially contracting it so that the central axis of the radially contracted configuration of the implant coincides with the axis of insertion and deployment of the implant into a body cavity of a human or animal through the distal end of the insertion device.
[0017] Optionally, such a medical assembly may comprise an implant crimping element having an implant retaining ring in a radially contracted configuration, the retaining ring being slidably mounted around the implant receiving chamber between a retracted position around the proximal or distal wall of the implant receiving chamber that allows the implant receiving chamber to open and a crimping position around the central portion of the implant receiving chamber, ensuring that the chamber is at least partially closed.
[0018] The present invention will be better understood using the following description, which is given by way of example only and with reference to the accompanying drawings.
Brief Description of the Drawings
[0019]
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DETAILED DESCRIPTION OF THE INVENTION
[0020] The medical implant 10 schematically shown in the perspective view of FIG. 1A and the top view of FIG. 1B includes a single, essentially cylindrical perforated wall 12 of an elastic structure, more precisely a flexible structure, intended to surround a biological ridge existing within a body cavity of a human or an animal in order to fix the implant 10 around this biological ridge. According to the general principle of the present invention, this wall 12 is formed over the entire cylindrical side surface of the implant 10 except for at least one limiting angular portion 14 of its outer periphery, and thus forms a longitudinal opening in the overall tubular form assumed by the implant 10. This particular shape of the wall 12 imparts radial elasticity to the cylindrical side surface of the implant 10 during contraction and expansion. More precisely, in this first assumed embodiment, the wall 12 is formed over the entire cylindrical side surface of the implant 10 except for the full length of a single limiting angular portion 14. The latter can be defined angularly from the central longitudinal axis 16 of the implant 10, i.e., according to the angle θ specified in FIG. 1A, or by its width, i.e., according to the linear distance D specified in FIG. 1B or the length of the corresponding arc.
[0021] The radial elasticity of the implant 10 may be obtained on the one hand by its perforated configuration and on the other hand by the material constituting its wall 12.
[0022] As far as the constituent material is concerned, approval must be obtained for medical use of implantation into the cavities of the human or animal body, for example in the case of nickel-titanium. Advantageously, it is also absorbable, i.e. it has biodegradability within a predetermined period. This predetermined period can be determined according to its use, especially so that it is not necessary to remove the implant after insertion. However, this can also be a simple safety function, whereby the implant can still be removed after a desired treatment period shorter than this predetermined period. This can be an absorbent polymer matrix having flexibility to some extent, for example a biodegradable polyester matrix, especially polycaprolactone (PCL) and / or polylactic acid (PLA).
[0023] Regarding the porous configuration, i.e. the configured with openings, it of the wall 12 of the implant 10 is slightly elastic but suitable for a considerably flexible constituent material such as PCL, i.e. having a potentially greater radial elasticity than PLA. The result is a solid surrounding frame 18 surrounding the wall 12, suitable for restricting this radial elasticity, and a plurality of solid ribs 20, 22, 24 formed inside this frame 18. The ribs are wide enough to ensure that the essentially cylindrical form of the wall 12 is maintained. The first rib 20, which is diametrically opposed to the longitudinal opening formed in the limit angle portion 14, extends longitudinally parallel to the opening along the entire length of the wall 12, configuring it into two continuous porous half-walls. Two further ribs 22 extend along the first diameter of each of the two half-walls from the first rib 20 at the distal end 26 of the wall 12 to the vicinity of the limit angle portion 14 at the proximal end 28 of the wall 12. A plurality of further ribs 24 extend within each half-wall parallel to its second diameter, for example, in the example shown in FIGS. 1A and 1B, there are six further ribs 24 per half-wall.
[0024] Due to the longitudinal opening formed in the implant 10 by the limiting angle portion 14, the distal end 26 is open and unrestricted at this limiting angle portion 14 for the assumed sliding engagement of the biological ridge inside the implant 10 from this distal end 26. On the other hand, the proximal end 28 has an abutting portion 30 and is configured to limit the assumed engagement of the biological ridge inside the implant 10 to this abutting portion 30.
[0025] More precisely, in the non-limiting example shown in FIGS. 1A and 1B, the abutting portion 30 is formed by two extensions 30A and 30B, and these extensions extend from the proximal end 28 of the wall 12 and are shaped to form the base of the abutting portion for the biological ridge when the biological ridge engages within the implant 10 over the entire length of the limiting angle portion 14. Even more precisely, the two extensions 30A and 30B are in the form of hooks, the base of which is integral with the wall 12 and is symmetrically arranged on both sides of the longitudinal opening formed in the implant 10 by the limiting angle portion 14 according to the symmetry plane of the implant 10 centered on the limiting angle portion 14, and the hook-shaped free ends thereof intersect the limiting angle portion 14 at a position at a distance from the proximal end 28.
[0026] Regarding dimensions, the implant 10 has, for example, a diameter (configured to extend radially) of approximately 10 mm with respect to a wall 12 having a length of approximately 30 mm beyond the proximal end 28, and the abutment portion 30 extends an additional approximately 10 mm from its proximal end. The longitudinal opening formed by the limit angle portion 14 where the wall 12 does not extend inwards has, for example, a linear width D = 4.8 mm, which corresponds to an opening angle θ of π / 4 to π / 3 rad. More generally, with the opening angle θ being π / 2 rad or less, it becomes possible to insert a biological ridge and hold the implant 10 in place. The two hook-shaped ends of the abutment portion 30 are separated by approximately 1.1 mm. Such an implant 10 with such dimensions and design is suitable for placement around the inferior nasal concha of the human body and also for the treatment of medical conditions such as rhinitis. It should be noted that the constituent material and dimensions of the implant 10 can be changed for other uses such as placement around the middle nasal concha or other ridges, for animals, for the treatment of paranasal sinusitis, etc.
[0027] The medical implant 40, schematically shown in the perspective views of FIGS. 2A and 2B, the front view from the proximal side of FIG. 2C, the sectional view of FIG. 2D along the section A - A shown in FIG. 2C, and the flattened, expanded, and opened view of FIG. 2E, comprises a single substantially cylindrical wall 42 having a diamond mesh structure that is radially elastic, more precisely further extensible, intended to surround a biological ridge for fixing the implant 40 around the biological ridge present within a body cavity of a human or an animal. It should be noted that although FIG. 2E is a theoretical depiction, since the implant 40 is cylindrical and closed laterally while being flattened, expanded, and opened, the depiction serves to clarify its structure.
[0028] The substantially cylindrical shape of the wall 42 provides, by means of the diamond mesh, a cylindrical side surface having radial elasticity, or more precisely an expandable cylindrical side surface, on the implant 40. According to the general principle of the invention, this wall 42 is formed over the entire cylindrical side surface of the implant 40, except for at least one limiting angular portion 44 of its outer periphery, and thus forms a longitudinal opening in the generally tubular form assumed by the implant 40. More precisely, in this second assumed embodiment, the wall 42 is formed over the entire cylindrical side surface of the implant 40, except for the full length of a single limiting angular portion 44. The latter can be defined angularly, i.e. according to an angle θ similar to that specified in FIG. 1A, or by its width, i.e. according to a linear distance or the length of a corresponding arc similar to that specified in FIG. 1B, from the central longitudinal axis (not shown) of the implant 40.
[0029] As mentioned above, the radial elasticity of the implant 40 can be obtained, on the one hand, by its diamond mesh configuration and, on the other hand, by the material constituting its wall 42.
[0030] As mentioned above, the constituent material can be an absorbent polymer matrix, such as a biodegradable polyester matrix having flexibility to a certain degree, in particular polycaprolactone (PCL) or polylactic acid (PLA). It can also be nickel - titanium or any other biocompatible material.
[0031] Regarding the diamond mesh configuration, the configuration of the wall 42 of the implant 40 is suitable for a constituent material having a certain rigidity, such as PLA, which is less deformable than PCL, i.e. having potentially limited elasticity and radial expandability, although PCL is also fully feasible. As a result, in this embodiment, there is no surrounding frame for the wall 42.
[0032] The distal end 46 of the wall 42, clearly visible in FIG. 2B, is open and unrestricted at this limiting angle portion 44 by the longitudinal opening formed in the implant 40 by the limiting angle portion 44 for the assumed sliding engagement of the biological ridge inside the implant 40 from this distal end 46. On the other hand, the proximal end 48 of the wall 42, clearly visible in FIG. 2A, has an abutting portion 50 and is adapted to limit the assumed engagement of the biological ridge inside the implant 40 up to this abutting portion 50 along the entire length of the limiting angle portion 44.
[0033] More precisely, the abutting portion 50 consists at least of a rod extending circumferentially with respect to the proximal end 48. This rod is, for example, an extension of the diamond mesh forming the wall 42. This can be complemented by a base 52 for the abutting portion 50 clearly visible in FIGS. 2A, 2C and 2E, the base itself being formed, for example, by three extensions 52A, 52B, 52C, one of which is oval (52A) and two of which are kidney-shaped (52B, 52C), which can be bent at right angles or at an angle close to right angles towards the inside of the wall 42 to form the base 52. These three extensions 52A, 52B, 52C also extend in the diamond mesh of the proximal end 48 of the wall 42 as shown in FIG. 2E.
[0034] Furthermore, the implant 40 optionally comprises a plurality of elongated spatulas, in particular four elongated spatulas 54A, 54B, 54C and 54D, extending at the distal end 46 of the wall 42 and bent inwards towards the wall 42. These are clearly shown in FIGS. 2D and 2E. When the implant 40 is arranged around the biological ridge and radially deployed to contact the surrounding biological wall, the internal contact between the implant 40 and the biological ridge can be maintained thereby.
[0035] With regard to dimensions, the implant 40 may be similar to the implant 10 for placement around the inferior nasal concha of the human body and for treating medical conditions such as rhinitis. The longitudinal opening formed by the limit angle portion 44 where the wall 42 does not extend has an opening angle θ of, for example, about 4π / 9 rad + / - 10%. More generally, by having the opening angle θ of π / 2 rad or less, the insertion of the biological ridge and the retention of the implant 40 in place are made possible. The constituent material and dimensions of the implant 10 may be changed for other applications such as placement around the nasal middle concha or other ridges, for animals, for the treatment of paranasal sinusitis, etc.
[0036] The medical implant 60 is schematically shown in the perspective view of FIG. 3A, the top view of FIG. 3B, and the flattened, unfolded, and open view of FIG. 3C, and includes two semi-cylindrical walls 62A and 62B having a wire structure element characterized by undulations, the structure element being folded back on itself several times along a variable length and being adapted to increase or decrease monotonically for each of the two semi-cylindrical walls 62A and 62B in particular. According to the general principle of the present invention, the latter are formed opposite each other across the entire cylindrical side surface of the implant 60 except for the two limit angle portions 64A and 64B on the outer periphery of the implant 60, and are radially opposed between these two walls so as to surround a biological ridge for fixing the implant 60 around the biological ridge present in a body cavity of a human or animal, and thus form a longitudinal through-opening in the generally tubular form assumed by the implant 60. It should be noted that although FIG. 3C is a theoretical depiction, being flattened, unfolded, and open, while the implant 60 is cylindrical and laterally closed, this depiction serves to clarify its structure.
[0037] The substantially cylindrical form of the two semi-cylindrical walls 62A and 62B gives the implant 60 a cylindrically shaped side surface that is radially elastic, or more precisely extensible, by virtue of a plurality of bends in their wire structure. More precisely, in this third assumed embodiment, the two semi-cylindrical walls 62A and 62B are formed over the entire cylindrical side surface of the implant 60, except for the full length of the two limit angle portions 64A and 64B. The latter can be defined angularly from the central longitudinal axis (not shown) of the implant 60, i.e., according to an angle θ similar to that specified in FIG. 1A, or by their width, i.e., according to a linear distance or the length of a corresponding arc similar to that specified in FIG. 1B.
[0038] As described above, the radial elasticity of the implant 60 is achieved on the one hand by the wire bending configuration of its two walls 62A, 62B and on the other hand possibly by their constituent material.
[0039] As described above, the constituent material can be an absorbent polymer matrix having a certain degree of flexibility, for example a biodegradable polyester matrix, in particular polycaprolactone (PCL) or polylactic acid (PLA). It can also be nickel-titanium, which is particularly well suited for medical wire structures. This material is also known for its advantageous properties of low-temperature rigidity, shape memory at human body temperature and superelasticity. This can also be assumed in the above-described embodiments.
[0040] In a configuration having wire bends, each semi-cylindrical wall 62A or 62B can have, for example, six bends whose size increases or decreases, as shown in FIG. 3C.
[0041] The distal ends 66A and 66B of the two walls 62A and 62B are open and unrestricted at these limiting angle portions 64A and 64B for the assumed sliding engagement with the biological ridges within the implant 60 by two longitudinally opposed openings formed in the implant 60 by the limiting angle portions 64A and 64B. On the other hand, the proximal ends 68A and 68B of the two walls 62A and 62B each have abutting portions 70A, 70B, which are adapted to limit the assumed engagement of the biological ridges inside the implant 60 up to these two abutting portions 70A, 70B over the entire length of the limiting angle portions 64A and 64B.
[0042] More precisely, each of the abutting portions 70A, 70B is formed by a rod extending circumferentially at least at the proximal ends 68A and 68B. This rod is, for example, an extension of a bent rod that can form each of the walls 62A, 62B.
[0043] With regard to dimensions, the implant 60 has a diameter of approximately 22 mm (in a radially expanded configuration) with respect to the length of the walls 62A, 62B that is variable between approximately 15 mm and 30 mm, for example, for placement around the middle nasal concha of the human nasal cavity and for the treatment of medical conditions such as rhinosinusitis. Each longitudinal opening formed by each of the limiting angle portions 64A, 64B where each of the walls 62A, 62B does not extend has an opening angle θ of, for example, approximately π / 3 rad + / - 10%. More generally, the insertion of the biological ridges and the retention in place of the implant 60 are made possible by the opening angle θ being less than or equal to π / 2 rad. The constituent material and dimensions of the implant 60 can be changed for other applications such as placement around the inferior nasal concha or other ridges, for animals, for the treatment of rhinitis, etc.
[0044] A first modification 80 of the implant 60 according to a fourth embodiment of the present invention is schematically shown in the perspective view of FIG. 4A and the top view of FIG. 4B. Its components are the same as those of the third embodiment and have the same reference numerals, namely two semi-cylindrical walls 62A and 62B having wire structure elements, two limiting angle portions 64A and 64B, two distal ends 66A and 66B of the two walls 64A and 64B, and two proximal ends 68A and 68B of the two walls 64A and 64B.
[0045] On the other hand, the two abutting portions 82A and 82B of the implant 80 are different from the two abutting portions 70A and 70B of the implant 60 in that they are located at the central position with respect to the shortest length of the wall located on the side of the abutting portion 82A instead of the proximal ends 68A and 68B of the two walls 64A and 64B. Thereby, the movement of the implant 80 along the biological ridge is restricted.
[0046] This first modification 80 is also suitable for placement around the middle turbinate of the nasal cavity of the human or animal body and for the treatment of medical conditions such as sinusitis. This can also be modified for other uses.
[0047] A second modification 90 of the implant 60 according to a fifth embodiment of the present invention is schematically shown in the perspective view of FIG. 5A and the top view of FIG. 5B. Its components are the same as those of the third embodiment and have the same reference numerals, namely two limiting angle portions 64A, 64B, two distal ends 66A, 66B of the two wire structure element walls, and two proximal ends 68A, 68B of these two walls.
[0048] On the one hand, the two semi-cylindrical walls 92A and 92B of the implant 90, together with their wire-like structural elements, are different from the walls 62A and 62B of the implants 60 and 80 in that their lengths are constant and do not increase or decrease monotonically. More specifically, the wall 92A has a large constant length, for example, about 30 mm, and the wall 92B has a small constant length, for example, about 15 mm. The two abutting portions 94A and 94B of the implant 90 are also different from the abutting portions 70A, 70B of the implant 60 and the abutting portions 82A, 82B of the implant 80 by their intermediate arrangement, and are located at an intermediate position between the proximal ends 68A and 68B of the two walls 92A and 92B and the central position of the first modification example, rather than at the proximal ends of these two walls 92A and 92B.
[0049] This second modification example 90 is also suitable for placement around the middle nasal concha of the nasal cavity of a human or animal and for treating medical conditions such as sinusitis. It can also be modified for other uses.
[0050] The medical implant 40' schematically shown in the perspective view of FIG. 6A, the top view of FIG. 6B, the proximal or distal front view of FIG. 6C, and the flattened, unfolded, and open view of FIG. 2D is a simplified modification of the implant 40 of FIGS. 2A-2E. It has the same essential features. However, it differs in that the abutting portion 50, the base 52 of the abutting portion, and the elongated blades 54A, 54B, 54C, and 54D do not exist. It also differs in that, in the same spirit as the solid peripheral frame 18 of the embodiment shown in FIGS. 1A and 1B, two strips 96A and 96B are added for the proximal and distal reinforcement of the two respective sides of its wall 42. Thus, these two bands 96A, 96B extend in a ring shape from the proximal end 48 to the distal end 46 over the entire cylindrical side surface of the implant 40', excluding the limiting corner portion 44 of its outer periphery.
[0051] Regarding materials and dimensions, the implant 40' is the same as the implant 40 for the same application.
[0052] Each of the implants 10, 40, 40', 60, 80 or 90 is designed to be introduced into the nasal cavity 100, for example, as shown in the sagittal section of FIG. 7A. The nasal cavity 100 (also called the nasal fossa) extends behind the nostril opening 102, and these implants can be introduced from the nostril opening using a specific insertion deployment device. The superior nasal concha 104, the middle nasal concha 106 and the inferior nasal concha 108 function as filters and allow air and other fluids to flow freely.
[0053] During ENT surgery that affects the middle nasal concha 106 and / or the inferior nasal concha 108, any of the aforementioned implants can be placed around the middle nasal concha 106 within the cylindrical arrangement 110 shown by the dotted line (in this case, implants 60, 80 or 90 are more suitable, but not limited thereto, and implants 10, 40 and 40' may also be suitable), and / or can be placed around the inferior nasal concha 108 within another cylindrical arrangement 112 also shown by the dotted line (in this case, implants 10, 40 and 40' are more suitable, but not limited thereto, and implants 60, 80 and 90 may also be suitable).
[0054] FIG. 7B shows a schematic front sectional view of the nasal cavity 100. The arrangements 110 and 112 are shown around the middle nasal concha 106 and the inferior nasal concha 108 in the deployment configuration of the implant, with respect to 60, 80 or 90 for arrangement 110 and 10, 40 or 40' for arrangement 112. This shows the support that the implants 10, 40, 40', 60, 80 or 90 can take against the inner wall of the nasal cavity 100 while being placed and fixed around the middle nasal concha 106 and the inferior nasal concha 108 by their longitudinal openings. This stable arrangement prevents them from being discharged through the nasal cavity 102 or being taken in through the oropharynx 114, as shown in FIG. 7A.
[0055] Here, with reference to FIGS. 8A and 8B, an apparatus 120 for inserting and deploying any of the above-described implants will be described. Other known apparatuses for inserting and deploying any of the above-described implants around a cavity of a human or animal body, particularly around the middle nasal concha or the inferior nasal concha of the nasal cavity, may be envisioned. However, the apparatus 120 has advantageous technical features for such implants, particularly due to the cylindrical form of such implants. However, the apparatus 120 is also suitable for cylindrical implants having no longitudinal opening resulting from an essentially cylindrical wall formed over the entire cylindrical side surface of the implant, except for at least one limiting angular portion of the outer periphery of the implant, other than those described above. In this regard, the object constituted by the insertion device 120 and the object constituted by any of the aforementioned implants are independent of each other, but advantageously are combined in a single medical assembly.
[0056] A non-limiting embodiment of the insertion and deployment device 120 is schematically shown in a side view of the left side portion and a cross-sectional view of the right side portion of FIG. 8A in a first open configuration.
[0057] More specifically, FIG. 8A shows a medical assembly for introducing an implant into a cavity of a human or animal body, the medical assembly comprising - any medical implant having a wall formed from an elastic structure, such as one of those described above, particularly the implant 40 for illustrative purposes only, and - the insertion and deployment device 120 in a first open configuration. and is provided with.
[0058] The device 120 comprises an essentially cylindrical sleeve 122 having a proximal hole 124 for introducing any rod suitable for ENT surgery, such as an endoscope 128, through the proximal end 126 of the sleeve 122. A partially threaded longitudinal hole 130 is drilled around the longitudinal axis of the sleeve 122 at the proximal end 126 to provide access to the hole 124 and to allow a cylindrical seal 132 to be fitted and a threaded plug 134 to be screwed in. The sleeve 122 also has a radially drilled hole 136 which provides access to the hole and, if necessary, prevents longitudinal movement of the endoscope 128 with a pin (not shown).
[0059] The proximal hole 124 opens from the inside of the sleeve 122 into a recess 138 which extends to the distal end 140 of the sleeve 122. This recess 138 contains the base of a finger-operated button 142 which slides along a groove 144 formed longitudinally in the wall of the sleeve 122. It also includes a sliding hollow tube 146 which is integral with the base of the sliding button 142 and is translatable by the sliding button along the longitudinal axis of the sleeve 122, which longitudinal axis is also the axis for the insertion and deployment of the implant 40 into a body cavity of a human or animal.
[0060] The distal end 140 of the sleeve 122 is integral with the chamber 148, which extends along its longitudinal axis. This chamber 148 receives the implant 40 and radially contracts such that the central axis of this radially contracted configuration of the implant 40 coincides with the longitudinal axis of the sleeve 122. The chamber 148 has a proximal wall 150 for attachment to the distal end 140 of the sleeve 122. On the opposite side, it has a distal wall 152 for attachment to the tubular distal end 154 of the insertion device 120, through which the implant 40 is designed to exit for insertion and deployment into the body cavity of the human or animal in question. The tubular distal end 154 has two longitudinal notches for forming a tongue 156, the free end of which curves slightly towards the inside of the tube. In this manner, this tongue 156 can function as a guide when the implant 40 exits and fits precisely into its longitudinal opening formed by the limiting angular portion 44 of its outer periphery where the wall 42 is not formed.
[0061] The chamber 148 is surrounded by a crimping element 158 that forms its side walls between its two other proximal wall 150 and distal wall 152. More specifically, the crimping element 158 comprises a plurality of flexible tabs including five flexible tabs 160, 162, 164, 166 and 168, as well as a rigid tab 170. These six tabs are arranged in a hexagonal shape to form a cylindrical chamber 148 having a hexagonal base around the implant 40. Each flexible tab 160, 162, 164, 166 or 168 has thin-ended portions that are integral with the proximal wall 150 and distal wall 152 of the chamber 148 respectively, and a central portion that also includes a reduced-thickness region. These zones of reduced thickness ensure its flexibility. The rigid tab 170 is of the same length or an equivalent length, but is attached to only one of the two walls of the proximal 150 and distal 152, sliding while guiding on the other, allowing the flexible tabs to spread without twisting by their reduced-thickness regions and opening the chamber to facilitate the insertion of the implant 40 into the chamber 148. The device 120 in this open configuration of the chamber 148 is shown in FIG. 8A.
[0062] Advantageously, the longitudinal opening of the implant 40 formed by the limit angle portion 44 of the outer periphery where the wall 42 is not formed is disposed with respect to the rigid tab 170. This rigid tab 170 forms a reference point for angularly positioning the implant 40 around the longitudinal axis of the device 120. Thus, it extends in a plane parallel to the plane of the base of the tab 156. This also provides a constant hold on the crimping element 158.
[0063] Alternatively, the flexible crimping tab can be replaced by equivalent crimping means such as a braided mesh or a stent-like structure.
[0064] The crimping element 158 further includes a ring 172 for holding the flexible tabs 160, 162, 164, 166, and 168 in a flat configuration to close the chamber 148 in order to maintain the implant in its radially contracted configuration. This retaining ring 172 is slidably mounted along and around the six tabs 160, 162, 164, 166, 168, and 170.
[0065] The left side of FIG. 8A shows a state where the ring is in a retracted position around the distal wall 152 of the chamber 148, and the flexible tabs 160, 162, 164, 166, and 168 are spread, allowing the implant 40 to be inserted into the chamber 148.
[0066] The left side of FIG. 8B shows the state in which the ring has become a crimping position around the central portions of the flexible tabs 160, 162, 164, 166 and 168 by flattening these tabs. In this configuration, the chamber 148 is closed and the inside of the implant is radially contracted such that its central axis coincides with the longitudinal axis of insertion and deployment of the device 120. Also, in this configuration, the diameter of the contracted implant 40 corresponds to the diameter of the sliding hollow tube 146. Thus, by operating the sliding button 142, the implant 40 can be pushed by the sliding hollow tube 146 towards the distal end 154 of the device 120 and then outwards, i.e., into the body cavity of the human or animal in question.
[0067] Next, a method of inserting and deploying a medical implant into a body cavity of a human or animal using the assemblies of FIGS. 8A and 8B will be described with reference to FIG. 9.
[0068] In a first step 200, the insertion and deployment device 120 is in an open configuration. In other words, by placing the retaining ring 172 in its retracted position around the distal wall 152 and spreading the flexible tabs 160, 162, 164, 166 and 168, its chamber 148 is opened. The implant 10, 40, 40', 60, 80 or 90 is placed within the chamber 148 and loaded, for example, when the insertion and deployment device 120 is assembled.
[0069] In an optional step 202, the strip 174 can be introduced into the insertion and deployment device 120 from its distal end 154 to the proximal end of the implant 10, 40, 40', 60, 80 or 90, passed under the tongue 156 and along the longitudinal opening of the implant or one of its longitudinal openings.
[0070] In the next step 204, the retaining ring 172 is slid to its crimping position around the central portions of the flexible tabs 160, 162, 164, 166 and 168, thereby flattening them and then closing the chamber 148 around the radially contracted implant 10, 40, 40', 60, 80 or 90.
[0071] In subsequent step 206, the implant 10, 40, 40', 60, 80 or 90 is pushed towards the distal end 154 of the insertion deployment device 120 by operation on the sliding button 142. The strip 174 helps position its longitudinal opening relative to the tongue 156. Thereafter, it can be pulled out.
[0072]
[0071] In the next step 208, the distal end of the implant 10, 40, 40', 60, 80 or 90 is pushed towards the outlet of the distal end 154 of the insertion deployment device 120 by the ongoing operation on the sliding button 142.
[0073] Finally, in the last step 210, when the sliding button 142 reaches the end of its movement, the implant 10, 40, 40', 60, 80 or 90 can be fully introduced into the cavity of the subject human or animal body and deployed around the target biological ridge.
[0074] It is clear that a medical implant as described above is easy to manufacture and is practical for placement around biological ridges located inside the cavities of human or animal bodies where access can be difficult, particularly in ENT surgery.
[0075]
[0072] It is also clear that an insertion deployment device as described above greatly facilitates the introduction into the cavity of a human or animal body where access can be difficult for placement around a given biological ridge, and further for any of the above implants and also for other radially elastic cylindrical implants.
[0076] Note that it should be noted that the present invention is not limited to the above-described embodiments. In fact, it will be apparent to those skilled in the art that various changes can be made to the above-described embodiments in light of the teachings disclosed above. In the above detailed presentation of the present invention, the terms used should not be construed as limiting the present invention to the embodiments described herein, but should be construed as including all equivalents that can be predicted within the scope of those skilled in the art by applying their general knowledge to the implementation of the disclosed teachings.
Claims
1. A medical implant (10;40;40';60;80;90) for insertion into a cavity (100) of the body of a human or animal, comprising at least one wall (12;42;62A, 62B;92A, 92B) formed of an elastic structure intended to surround a biological protrusion (106, 108) present in the cavity (100) for fixation around the biological protrusion, wherein the at least one wall (12;42;62A, 62B;92A, 92B) is essentially cylindrical in shape and is formed over the entire cylindrical side surface of the implant except for at least one limiting angle portion (14;44;64A, 64B) on its outer circumference, At least one of the walls (12; 42; 62A, 62B; 92A, 92B) is perforated, The aforementioned at least one wall (12; 42; 62A, 62B; 92A, 92B) The structure is made of a solid periphery frame (18) surrounding the perforated at least one wall, and a plurality of solid ribs (20, 22, 24) formed inside the solid frame (18), or It is made from a radially elastic structure having a diamond mesh, or The structure is made from a radially elastic component having a wavy portion such that the radially elastic structural element is bent several times on itself, A medical implant (10;40;40';60;80;90) characterized in that radial elasticity is provided to the cylindrical side surface of the implant (10;40;40';60;80;90).
2. The medical implant (10;40;40';60;80;90) according to claim 1, wherein the at least one wall (12;42;62A, 62B;92A, 92B) is formed over the entire cylindrical side surface of the implant, except for the entire length of the at least one limit angle portion (14;44;64A, 64B) on its outer circumference.
3. - The distal end (26; 46; 66A, 66B), wherein at least one limiting angle portion (14; 44; 64A, 64B) is open and unrestricted for the assumed sliding engagement of the biological protrusions (106, 108) within the implant from the distal end (26; 46; 66A, 66B), - Proximal ends (28; 48; 68A, 68B) having contact portions (30; 50; 70A, 70B), wherein the contact portions are intended to limit the anticipated engagement of the biological ridges (106, 108) on the inside of the implant up to the contact portion, A medical implant according to claim 1, comprising (10; 40; 60; 80; 90).
4. - The distal end (26; 46; 66A, 66B), wherein at least one limiting angle portion (14; 44; 64A, 64B) is open and unrestricted for the assumed sliding engagement of the biological protrusions (106, 108) within the implant from the distal end (26; 46; 66A, 66B), - A plurality of elongated spatulas (54A, 54B, 54C, 54D), particularly four elongated spatulas, extending from the at least one wall (42) at the distal end (46) of the implant and bent inward from the at least one wall, A medical implant (40) according to claim 1, comprising the above.
5. A proximal end (28; 48; 68A, 68B) having contact portions (30; 50; 70A, 70B), wherein the contact portions are intended to limit the expected engagement of the biological ridges (106, 108) inside the implant up to the contact portion; and a plurality of extensions (30A, 30B; 52A, 52B, 52C) extending from the wall (12; 42) at the proximal end (28; 48) of the implant and shaped to form a base (30A, 30B; 52) of the contact portion (30; 50) for the biological ridges (106, 108) when the biological ridges (106, 108) engage within the implant, in particular, - Three extensions (52A, 52B, 52C), one of which is oval-shaped, two of which are kidney-shaped, and are bent at a right angle or nearly right angle to the inside of at least one wall (42), or - Two hook-shaped extensions (30A, 30B), wherein the bases of the two hook-shaped extensions are symmetrically arranged according to the plane of symmetry of the implant centered on the limit angle portion (14; 44), and the hook-shaped free ends of the two hook-shaped extensions intersect the limit angle portion (14), A medical implant according to claim 1, comprising a plurality of extensions (30A, 30B; 52A, 52B, 52C).
6. A medical implant (10) according to claim 1, comprising a single perforated wall (12) having a radially elastic structure, wherein the radially elastic structure comprises a solid periphery frame (18) surrounding the perforated wall and a plurality of solid ribs (20, 22, 24) formed inside the solid frame (18), wherein the single perforated wall (12) is formed over the entire cylindrical side surface of the implant (10), except for a single limit angle portion (14) on its outer circumference.
7. A medical implant (40;40') according to claim 1, comprising a single wall (42) of a radially elastic diamond mesh structure, wherein the single wall (42) extends over the entire cylindrical surface of the implant (40;40'), except for a single limiting angle portion (44) on its outer circumference.
8. A medical implant (60;80;90) according to claim 1, comprising two semi-cylindrical walls (62A, 62B; 92A, 92B) having radially elastic structural elements having wavy portions such that the structural elements can be bent several times on themselves, wherein the two walls (62A, 62B; 92A, 92B) are formed facing each other over the entire cylindrical surface of the implant (60;80;90), except for two limit angle portions (64A, 64B) on their outer circumference that are radially opposed between the two walls (62A, 62B; 92A, 92B).
9. A medical assembly for introducing an implant (10; 40; 40'; 60; 80; 90) into a cavity (100) of the body of a human or animal, - A medical implant (10; 40; 40'; 60; 80; 90) according to claim 1, - A device (120) for inserting and deploying the medical implant (10; 40; 40'; 60; 80; 90) into a cavity (100) of the body of a human or animal, Equipped with, A medical assembly comprising an insertion and deployment device (120) having a chamber (148) for receiving and radially contracting the implant (10;40;40';60;80;90) such that the central axis of the radially contracted configuration of the implant (10;40;40';60;80;90) is aligned with the axis of insertion and deployment of the implant into the cavity of the human or animal through the distal end (156) of the insertion and deployment device (120).
10. A medical assembly according to claim 9, comprising an implant (10;40;40';60;80;90) crimping element (158) having an implant (10;40;40';60;80;90) retaining ring (172) in a radially contracted configuration, wherein the retaining ring (172) is slidably mounted around the implant (10;40;40';60;80;90) receiving chamber (148) between a retracted position around the proximal wall (150) or distal wall (152) of the implant (10;40;40';60;80;90) receiving chamber (148) and a crimped position around the central portion of the implant (10;40;40';60;80;90) receiving chamber (148) to ensure that the chamber is at least partially closed.