Medical implant and medical assembly for introducing such implant into human or animal body cavity
By designing cylindrical implants with radial elasticity, the complexity and stability of the prior art traditional Chinese medicine implants in manufacturing and anatomical adaptability are solved, and the stable fixation of the biological protrusions in the nasal cavity is achieved. Effect.
Patent Information
- Application Number
- CN202380052265.3
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2022-07-07
- Filing Date
- 2023-07-06
- Publication Date
- 2025-02-21
AI Technical Summary
Existing medical implants have complexity and stability issues in industrial manufacturing and anatomical adaptability, especially when immobilizing around the nasal biological protrusion.
A cylindrical implant with radial elasticity is designed, with the side surfaces of which are cylindrical except for the finite angle part, which is easy to manufacture in the industry and is stable in the nasal cavity by designing radial elasticity and finite angle part.
The simplicity and anatomical adaptability of the implant in industrial manufacturing are achieved, ensuring stable and long-lasting fixation around biological protrusions in the nasal cavity, and are suitable for the treatment of diseases such as rhinitis.
Smart Images

Figure CN119497596A_ABST
Abstract
Description
Technical Field
[0001] The invention relates to a medical implant intended to be introduced into a body cavity of the human or animal body. The invention also relates to a medical assembly comprising such an implant and a device designed to introduce the implant into a body cavity of the human or animal body and to deploy it therein.
[0002] The invention applies more specifically to an implant comprising at least one wall formed by an elastic structure intended to surround a biological protrusion present in a body cavity in order to fix the implant around the biological protrusion. It should be noted that such a device, even if it is not intended to pass through or be introduced into any biological tissue, is still implantable and can therefore always be referred to as an "implant". It should also be noted that the elasticity of a structure is not necessarily related to the elasticity of its constituent material. In a known manner, a structure can be obtained that has elastic properties imparted by its construction, even if the elasticity of its constituent material is weak or even very weak. Background Art
[0003] Such an implant is, for example, the subject of patent document WO 2019 / 025695A1. In this document, the implant comprises at least one clamp comprising two flat walls, more precisely, two flat walls for clamping between them a biological protrusion, in particular the middle turbinate and / or the inferior turbinate of the human nasal cavity. Each flat wall comprises an elastic linear structural element having a plurality of folds of its own to allow, when the implant is introduced into an introduction and deployment device in the form of a syringe, the wall to contract laterally before the implant is introduced and then to expand laterally in the nasal cavity when leaving the syringe. This allows the implant to achieve a large lateral dimension so as to be stably and durably fixed around the biological protrusion while allowing it to be introduced into the nasal cavity through a narrow opening.
[0004] However, such a flat clamp-type configuration appears to be rather complex to manufacture industrially. Furthermore, the mechanical stabilization of each relevant biological protuberance is not ideal, so it is advantageous to provide anterior and posterior stabilizers, which further complicates the manufacture. Furthermore, the overall shape of the implant, which tends to exert pressure on each biological protuberance it clamps, is not anatomically optimal. Summary of the invention
[0005] It would therefore be desirable to provide a medical implant that overcomes at least some of the above-mentioned problems and limitations.
[0006] A medical implant is thus proposed, intended to be introduced into a body cavity of the human or animal body, comprising at least one wall formed by an elastic structure, intended to surround a biological protrusion present in the body cavity, in order to fix the medical implant around the biological protrusion, wherein the at least one wall is substantially cylindrical, formed over the entire cylindrical lateral surface of the medical implant, except in at least one limited angular portion of its circumference, thereby conferring radial elasticity to the cylindrical lateral surface of the medical implant.
[0007] Thus, the cylindrical shape of the implant is industrially easy to manufacture, taking into account the materials usually used for medical purposes. Moreover, it is more anatomically relevant, in particular when the target biological protrusion is the middle or inferior turbinate of the nasal cavity, since its radial elasticity allows it to be stably held against the surrounding anatomical walls in the expanded configuration, while the limited angular portion without walls forming a complete opening or recess in the direction of the cylindrical axis allows it to be positioned around the protrusion by sliding along this limited angular portion. The radial elasticity of this implant also allows it to be precisely positioned with the aid of an insertion and deployment device, into which the implant can be introduced in the collapsed configuration under elastic stress.
[0008] Optionally, said at least one wall is formed over the entire cylindrical side surface of the implant except over the entire length of said at least one limited angular portion of the circumference.
[0009] Also optionally, the implant may include:
[0010] - a distal end, at which the at least one limited angle portion is open and free so that the biological protrusion can be engaged into the medical implant from the distal end by sliding; and
[0011] - The proximal end has a stopper for limiting the ability of the biological protrusion to engage in the medical implant until the stopper is reached.
[0012] Also optionally, the implant may comprise a plurality of elongated press plates, in particular four elongated press plates, extending from the at least one wall at the distal end of the implant while being folded towards the interior of the at least one wall.
[0013] Also optionally, the implant may comprise a plurality of extensions extending from said at least one wall at the proximal end of the implant and shaped to form a bottom portion of a stop for the biological protrusion when the biological protrusion is engaged in the medical implant over the entire length of the limited angular portion, in particular:
[0014] - three extensions, one of which is oval and the other two are kidney-shaped, all folded at right or nearly right angles towards the interior of the at least one wall; or
[0015] - Two hook-shaped extensions, whose hook bases are arranged symmetrically to a symmetry plane of the implant centered on the limited angular portion and whose free hook ends are folded back into the limited angular portion.
[0016] Still alternatively, the implant may include a single fenestrated wall that is a radially resilient structure having a solid peripheral frame, the single fenestrated wall being formed over the entire cylindrical side surface of the implant except in a single limited angular portion of the implant circumference.
[0017] Still alternatively, the implant may include a single wall being a radially resilient structure having a diamond-shaped grid formed over the entire cylindrical side surface of the implant except in a single limited angular portion of the implant's circumference.
[0018] Also optionally, the implant may include two semi-cylindrical walls having a radially elastic structural element having wavy bends so that the structural element folds itself multiple times, the two semi-cylindrical walls being formed facing each other on the entire cylindrical side surface of the implant except in two limited angular portions of the implant circumference, wherein the two limited angular portions are radially opposite between the two semi-cylindrical walls.
[0019] A medical assembly for introducing an implant into a body cavity of a human or animal body is also proposed, comprising:
[0020] - a medical implant according to the invention; and
[0021] - Insertion and deployment devices for inserting a medical implant into a body cavity of the human or animal body and for deploying it in a body cavity;
[0022] The insertion and deployment device comprises a chamber for receiving and radially contracting the medical implant so that the central axis of the radially contracted configuration of the medical implant coincides with the axis of inserting the medical implant into the body cavity of the human or animal body through the distal end of the insertion and deployment device and deploying it in the body cavity.
[0023] Optionally, such a medical component may include a crimping element for crimping a medical implant, the crimping element having a retaining ring for maintaining the medical implant in its radially contracted configuration, the retaining ring being mounted to slide around a chamber for receiving the medical implant between a retracted position and a crimping position, the retracted position being a position around a proximal wall or a distal wall of the chamber for receiving the medical implant to allow the chamber to be opened, and the crimping position being a position around a central portion of the chamber for receiving the medical implant to ensure that the chamber is at least partially closed. BRIEF DESCRIPTION OF THE DRAWINGS
[0024] The invention will be better understood with the aid of the following description, given by way of example only, and made with reference to the accompanying drawings, in which:
[0025] Figure 1A The overall structure of a medical implant according to a first embodiment of the present invention is schematically shown in a perspective view,
[0026] Figure 1B Schematically shown in top view Figure 1A Medical implants,
[0027] Figure 2A The overall structure of a medical implant according to a second embodiment of the present invention is schematically shown in a first perspective view.
[0028] Figure 2B The second perspective view schematically shows Figure 2A Medical implants,
[0029] Figure 2C Schematically shown in a proximal elevation view Figure 2A Medical implants,
[0030] Figure 2D Schematically shown in cross-sectional view Figure 2A Medical implants,
[0031] Figure 2E Schematically shown in flat, unfolded and opened views Figure 2A Medical implants,
[0032] Figure 3A The overall structure of a medical implant according to a third embodiment of the present invention is schematically shown in a perspective view.
[0033] Figure 3B Schematically shown in top view Figure 3A Medical implants,
[0034] Figure 3C Schematically shown in flat, unfolded and opened views Figure 3A Medical implants,
[0035] Figure 4A The overall structure of a medical implant according to a fourth embodiment of the present invention is schematically shown in a perspective view.
[0036] Figure 4B Schematically shown in top view Figure 4A Medical implants,
[0037] Figure 5A The overall structure of a medical implant according to a fifth embodiment of the present invention is schematically shown in a perspective view.
[0038] Figure 5B Schematically shown in top view Figure 5A Medical implants,
[0039] Fig. 6A The overall structure of a medical implant according to a sixth embodiment of the present invention is schematically shown in a perspective view.
[0040] Figure 6B Schematically shown in top view Fig. 6A Medical implants,
[0041] Figure 6C Schematic and shown in proximal or distal elevation view Fig. 6A Medical implants,
[0042] Fig.6D Schematically shown in flat, unfolded and opened views Fig. 6A Medical implants,
[0043] Fig. 7A The human nasal cavity is shown in a sagittal section, wherein some arrangements of the medical implant according to the invention are schematically shown,
[0044] Figure 7B A schematic diagram of a human nasal cavity in front cross-section, wherein some arrangements of the medical implant according to the invention are schematically shown,
[0045] Fig. 8A A medical component in a first open configuration according to an embodiment of the present invention is schematically shown in a side view and a cross-sectional view,
[0046] Figure 8B Shown in side view and cross-sectional view Fig. 8A but in a second closed configuration,
[0047] Fig. 9 Show the use Fig. 8A and 8B The invention relates to a method for inserting a medical implant into a body cavity of a human or animal body and deploying the medical implant therein. DETAILED DESCRIPTION
[0048] exist Figure 1A In perspective and Figure 1BThe medical implant 10 schematically represented in a top view comprises a single perforated wall 12, which is generally cylindrical and is an elastic, more precisely flexible structure, intended to surround a biological protrusion present in a human or animal body cavity in order to fix the implant 10 around the biological protrusion. According to the general principle of the invention, the wall 12 is formed on the entire cylindrical side surface of the implant 10, except in at least one limited angular portion 14 of its circumference, so as to create a longitudinal opening in the overall tubular shape possessed by the implant 10. This special shape of the wall 12 gives the cylindrical side surface of the implant 10 radial elasticity for contraction and expansion. More precisely, in this possible first embodiment, the wall 12 is formed on the entire cylindrical side surface of the implant 10, except over the entire length of a single limited angular portion 14. The single limited angular portion can be angularly limited from the central longitudinal axis 16 of the implant 10, that is, according to Figure 1A It can be defined by the angle θ indicated in the figure, or it can be defined by its width, that is, by Figure 1B It is defined by the linear distance d indicated in or a corresponding arc length.
[0049] The radial elasticity of the implant 10 is achieved on the one hand by its open-cell design and, if appropriate, on the other hand, by the material of which its wall 12 is composed.
[0050] As regards the constituent material, it must be approved for medical use for implantation in a body cavity of the human or animal body, such as in the case of nickel titanium. Advantageously, it is additionally absorbable, i.e. biodegradable within a predetermined period of time. This predetermined period of time can be defined according to its use, in particular so that the implant does not need to be removed after placement. But this can also be a simple safety measure, since the implant can still be removed after a desired treatment period that is shorter than the predetermined period of time. Thus, it can be an absorbable polymer matrix, such as a more or less flexible biodegradable polyester matrix, in particular polycaprolactone (PCL) and / or polylactic acid (PLA).
[0051] With regard to the open-cell construction, the open-cell construction of the wall 12 of the implant 10 is adapted to be more fairly flexible and less elastic constituent materials such as PCL, i.e., it has greater radial elasticity than PLA is possible. This results in a solid peripheral frame 18 surrounding the wall 12 that is capable of limiting this radial elasticity, and a plurality of solid ribs 20, 22, 24 formed within the frame 18. These ribs are wide enough to ensure that the generally cylindrical shape of the wall 12 is maintained. A first rib 20, which is radially opposite to the longitudinal opening formed in the limited angle portion 14, extends longitudinally parallel to the opening over the entire length of the wall 12 so as to construct it into two adjacent open-cell half-walls. Two other ribs 22 extend along a first diameter of each of the two half-walls from the first rib 20 at the distal end 26 of the wall 12 to near the limited angle portion 14 at the proximal end 28 of the wall 12. A plurality of other ribs 24 extend in each half-wall parallel to its second diameter, for example at Figure 1A and 1B In the example shown, each half-wall has six further ribs 24 .
[0052] Due to the longitudinal opening created by the limited angle portion 14 in the implant 10, the distal end 26 is open and free in the limited angle portion 14 so that the biological protrusion can be engaged into the implant 10 by sliding from the distal end 26. In contrast, the proximal end 28 has a stopper 30 for limiting the biological protrusion from engaging into the implant 10 until the stopper 30.
[0053] More precisely, in Figure 1A and 1B In a non-limiting example, the stopper 30 is formed by two extensions 30A and 30B extending from the proximal end 28 of the wall 12 and shaped to form the bottom of the stopper for the biological protrusion when the biological protrusion is engaged in the implant 10 over the entire length of the limited angle portion 14. More precisely, the two extensions 30A and 30B are hook-shaped, and the hook bases integral with the wall 12 are symmetrically arranged on both sides of the longitudinal opening created in the implant 10 by the limited angle portion 14 according to the symmetry plane of the implant 10 centered on the limited angle portion 14, while the free hook ends thereof are folded back into the limited angle portion 14 away from the proximal end 28.
[0054] In terms of size, the implant 10 has a diameter equal to, for example, about 10 mm (in a radially extended configuration), a length of the wall 12 of about 30 mm, and the stopper 30 extending about 10 mm beyond the proximal end 28 of the wall. The longitudinal opening created by the wall 12 without the limited angle portion 14 extending therein has, for example, a linear width d=4.8 mm, which corresponds to an opening angle θ between π / 4 and π / 3 radians. More generally, an opening angle θ less than or equal to π / 2 radians allows the biological protrusion to be inserted and the implant 10 to be held in place. The two hook ends of the stopper 30 are folded toward each other until they are about 1.1 mm apart from each other. The implant 10 so dimensioned and designed is suitable for placement around the inferior turbinate of the human nasal cavity to treat conditions such as rhinitis. It should be noted that the constituent materials and dimensioning of the implant 10 can be modified for other applications for animals, such as placement around the turbinate or other protrusions in the nasal cavity to treat sinusitis, etc.
[0055] exist Figure 2A , 2B In perspective, Figure 2C In the near side view, Figure 2D China-Israel Figure 2C The cross-sectional view of section AA shown in Figure 2E The medical implant 40 schematically represented in a flat, unfolded and opened view comprises a single wall 42, which is generally cylindrical and is a radially elastic, more precisely even stretchable structure with a rhombus grid, intended to surround a biological protrusion present in a human or animal body cavity in order to fix the implant 40 around the biological protrusion. It should be noted that Figure 2E is a theoretical representation, as it is flat, unfolded and open, whereas implant 40 is cylindrical and laterally closed, but the representation clarifies its structure.
[0056] The generally cylindrical shape of the wall 42 gives the implant 40 a radially elastic, more precisely even stretchable, cylindrical lateral surface by means of a rhombus-shaped grid. According to the general principle of the invention, the wall 42 is formed over the entire cylindrical lateral surface of the implant 40, except in at least one limited angular portion 44 of its circumference, so as to create a longitudinal opening in the overall tubular shape possessed by the implant 40. More precisely, in this possible second embodiment, the wall 42 is formed over the entire cylindrical lateral surface of the implant 40, except over the entire length of a single limited angular portion 44. This single limited angular portion can be angularly defined from the central longitudinal axis (not shown) of the implant 40, i.e. in a manner parallel to the longitudinal axis of the implant 40. Figure 1A The angle θ is defined by an angle similar to the angle indicated in FIG. 1 , or it can be defined by its width, that is, by Figure 1B The linear distance indicated in is defined by a linear distance similar to that indicated in the figure or by a corresponding arc length.
[0057] As already mentioned, the radial elasticity of the implant 40 is achieved on the one hand by its diamond-shaped grid structure and, if applicable, on the other hand, by the material of which its wall 42 is composed.
[0058] As regards the material of construction, as mentioned above, it can be an absorbable polymer, such as a more or less flexible biodegradable polyester, in particular polycaprolactone (PCL) or polylactic acid (PLA). It can also be nickel titanium or any other biocompatible material.
[0059] With regard to the diamond grid configuration, this configuration of the wall 42 of the implant 40 is suitable for a material of construction having a certain rigidity, such as PLA, which has a weaker deformation performance than PCL, i.e., has a potentially limited radial stretchability and elasticity, although PCL is also fully conceivable. This makes it possible to have no peripheral frame for the wall 42 in this embodiment.
[0060] Due to the longitudinal opening created in the implant 40 by the limited angle portion 44, Figure 2B The distal end 46 of the wall 42 clearly visible in the embodiment is open and free in the limited angle portion 44 so that the biological protrusion can be engaged into the implant 40 by sliding from the distal end 46. Figure 2A The proximal end 48 of the wall 42 clearly visible in the figure has a stopper 50 for limiting the ability of the biological protrusion to engage into the implant 40 over the entire length of the limited angle portion 44 until the stopper 50 is reached.
[0061] More precisely, the stopper 50 is formed at least by a rod extending circumferentially at the proximal end 48. The rod is, for example, an extension of the diamond-shaped grid structure forming the wall 42. It can be completed by the bottom 52 of the stopper 50, such as Figure 2A , 2C As can be clearly seen in FIG. 2E , the bottom of the stopper itself is formed by, for example, three extensions 52A, 52B, 52C, one of which (52A) is oval and the other two (52B, 52C) are kidney-shaped, all of which can be folded at right angles or nearly right angles toward the interior of the wall 42 to form the bottom 52. The three extensions 52A, 52B, 52C also extend from the diamond-shaped grid structure at the proximal end 48 of the wall 42, as shown in FIG. Figure 2E shown.
[0062] The implant 40 may also optionally include a plurality of elongated pressure plates, in particular four elongated pressure plates 54A, 54B, 54C and 54D, which extend from the wall 42 at the distal end 46 of the wall and are folded toward the interior of the wall 42. Figure 2D and 2E They allow internal contact to be maintained between the implant 40 and the biological protrusion when the implant 40 is arranged around the biological protrusion and radially expanded to contact the surrounding biological wall.
[0063] Implant 40 may be similar to implant 10 in terms of size for placement around the inferior turbinate of a human nasal cavity and for treating conditions such as rhinitis. The longitudinal opening created by wall 42 having no limited angle portion 44 extending therein may have, for example, an opening angle θ of approximately 4π / 9 radians + / - 10%. More generally, an opening angle θ of less than or equal to π / 2 radians allows for insertion of a biological protrusion and retention of implant 40 in place. The materials of construction and sizing of implant 10 may be modified for other applications for use in animals, such as placement around a turbinate or other protrusion in the nasal cavity to treat sinusitis, etc.
[0064] exist Figure 3A In perspective, Figure 3B In the top view and Figure 3C The medical implant 60 schematically represented in a flat, unfolded and opened view comprises two semi-cylindrical walls 62A and 62B having linear structural elements having wavy meanders such that, for each of the two semi-cylindrical walls 62A and 62B, the structural elements are folded on themselves multiple times with a variable length that is particularly monotonically increasing or decreasing. According to the general principles of the invention, these semi-cylindrical walls are formed facing each other over the entire cylindrical side surface of the implant 60, but except in two limited angular portions 64A and 64B of their circumference that are diametrically opposite between the two walls, thereby creating a through longitudinal opening in the overall tubular shape of the implant 60 to surround a biological protrusion present in a human or animal body cavity in order to fix the implant 60 around the biological protrusion. It should be noted that Figure 3C is a theoretical representation, as it is flat, unfolded and open, whereas implant 60 is cylindrical and laterally closed, but the representation clarifies its structure.
[0065] The generally cylindrical shape of the two semi-cylindrical walls 62A and 62B, through the multiple folding of their linear structure, gives the implant 60 a radially elastic, more precisely even stretchable, cylindrical side surface. More precisely, in this possible third embodiment, the two semi-cylindrical walls 62A and 62B are formed over the entire cylindrical side surface of the implant 60, except for the entire length of the two limited angular portions 64A and 64B. The two limited angular portions can be defined angularly from the central longitudinal axis (not shown) of the implant 60, i.e. at a length which is equal to the length of the implant 60. Figure 1A The angle θ is defined by an angle similar to the angle indicated in FIG. 1 , or it can be defined by its width, that is, by Figure 1B The linear distance indicated in is defined by a linear distance similar to that indicated in the figure or by a corresponding arc length.
[0066] As already mentioned, the radial elasticity of the implant 60 is obtained on the one hand by the linear folded configuration of its two walls 62A, 62B and, if necessary, on the other hand, also by the material from which it is composed.
[0067] As regards the material of construction, as mentioned above, it can be an absorbable polymer, such as a more or less flexible biodegradable polyester, in particular polycaprolactone (PCL) or polylactic acid (PLA). It can also be nickel titanium, which is particularly suitable for wire structures for medical use. This material is also admired for its advantageous properties of cold stiffness, shape memory at human body temperature and superelasticity. It can also be envisaged for use in the previous embodiments.
[0068] With regard to the linear folding configuration, each semi-cylindrical wall 62A or 62B may have, for example, six folds of increasing or decreasing size, such as Figure 3C as shown in .
[0069] With the two radially opposite longitudinal openings created by the limited angle portions 64A and 64B in the implant 60, the distal ends 66A and 66B of the two walls 62A and 62B are open and free in these limited angle portions 64A and 64B, so that the biological protrusions can be engaged into the implant 60 by sliding from these distal ends 66A and 66B. On the contrary, the proximal ends 68A and 68B of the two walls 62A and 62B each have a stopper 70A, 70B, which is used to limit the biological protrusions to be able to engage into the implant 60 over the entire length of the limited angle portions 64A and 64B until the two stoppers 70A and 70B.
[0070] More precisely, each stop 70A, 70B is formed at least by a rod extending circumferentially at the proximal ends 68A and 68B. This rod is, for example, an extension of a folding rod that may form each wall 62A, 62B.
[0071] In terms of size, the implant 60 has a diameter equal to, for example, about 22 mm (in a radially extended configuration) and a length of the walls 62A, 62B varying between about 15 mm and 30 mm for placement around the middle turbinate of the human nasal cavity for the treatment of conditions such as sinusitis. Each longitudinal opening created by each limited angle portion 64A, 64B in which each wall 62A, 62B does not extend has, for example, an opening angle θ of about π / 3 radians + / - 10%. More generally, an opening angle θ of less than or equal to π / 2 radians allows for insertion of a biological protrusion and retaining the implant 60 in place. The materials of construction and sizing of the implant 60 may be modified for other applications for use in animals, such as placement around the inferior nasal turbinate or other protrusions to treat sinusitis, etc.
[0072] According to a fourth embodiment of the present invention, Figure 4A In perspective and Figure 4BSchematically showing a first variant 80 of the implant 60 in a top view. The same components as those of the third embodiment are marked with the same reference numerals, namely the two semi-cylindrical walls 62A and 62B with linear structural elements, the two limited angle portions 64A and 64B, the two distal ends 66A and 66B of the two walls 64A and 64B, and the two proximal ends 68A and 68B of the two walls 64A and 64B.
[0073] On the contrary, the two stops 82A and 82B of the implant 80 differ from the two stops 70A, 70B of the implant 60 in that they are not arranged at the proximal ends 68A and 68B of the two walls 64A and 64B, but at an intermediate position relative to the minimum length of these walls, which is located on one side of the stop 82A. This allows limiting the travel of the implant 80 along the biological protrusion.
[0074] This first variation 80 is also suitable for placement around the middle turbinate of the nasal cavity of a human or animal body for treating conditions such as sinusitis. It can also be modified for other applications.
[0075] According to a fifth embodiment of the present invention, Figure 5A In perspective and Figure 5B Schematically showing a second variant 90 of the implant 60 in a top view. The same components as those of the third embodiment are marked with the same reference numerals, namely the two limited angle portions 64A and 64B, the two distal ends 66A and 66B of the two linear structural element-type walls, and the two proximal ends 68A and 68B of the two walls.
[0076] On the contrary, the two linear structural element semi-cylindrical walls 92A and 92B of implant 90 are different from the semi-cylindrical walls 62A and 62B of implants 60 and 80 in that their length is constant, without monotonically increasing or decreasing. More precisely, wall 92A has a constant large length, for example about 30 mm, while wall 92B has a constant small length, for example about 15 mm. The two stoppers 94A and 94B of implant 90 are also different from the stoppers 70A, 70B of implant 60 and the stoppers 82A, 82B of implant 80 in that they are arranged in the middle, that is, they are not arranged at the proximal ends 68A and 68B of the two walls 92A and 92B at all, but in an intermediate position between these proximal ends and the middle position of the first variant.
[0077] This second variation 90 is also suitable for placement around the middle turbinate of the nasal cavity of a human or animal body and is suitable for treating conditions such as sinusitis. It can also be modified for other applications.
[0078] In FIG. 6A, a perspective view is shown. Figure 6B6C in a top view, in a proximal or distal elevation view, and in a flat, unfolded and opened view schematically represented by the medical implant 40 'is Figures 2A to 2E The implant 40 is a simplified variation of the implant 40 in FIG. It contains its basic elements. However, it differs in that it does not have the stopper 50, the bottom 52 of the stopper and the elongated pressure plates 54A, 54B, 54C and 54D. Figure 1A and 1B The invention is similar to the solid peripheral frame 18 of the embodiment of the present invention, but differs in that two bands 96A and 96B are added to serve as two respective proximal and distal reinforcements of the wall 42. Thus, the two bands 96A, 96B extend in the form of rings at the proximal end 48 and the distal end 46, respectively, over the entire cylindrical side surface of the implant 40', except in a limited angular portion 44 of the implant circumference.
[0079] Implant 40' is similar to implant 40, for example, in terms of materials and dimensions, and is used for the same purpose.
[0080] For example, each of the implants 10, 40, 40', 60, 80 or 90 is intended to be introduced into Fig. 7A The nasal cavity 100, which is shown in a sagittal cross-section in FIG. 1 , extends behind the nostrils 102, also called the nasal cavity, through which these implants can be introduced with the aid of specific insertion and deployment devices. The superior turbinate 104, the middle turbinate 106, and the inferior turbinate 108 act as filters, allowing good circulation of air and other fluids.
[0081] During ENT surgery affecting the middle turbinate 106 and / or the inferior turbinate 108, any of the above-mentioned implants can be placed around the middle turbinate 106 in a cylindrical arrangement 110 represented by dashed lines (this then relates more to implants 60, 80 or 90, but this is not limiting and implants 10, 40 and 40' may also be suitable), and / or placed around the inferior turbinate 108 in another cylindrical arrangement 112 also represented by dashed lines (this then relates more to implants 10, 40 or 40', but this is no longer limiting and implants 60, 80 and 90 may also be suitable).
[0082] Nasal cavity 100 Figure 7BSchematically shown in front cross-sectional view. Cylindrical arrangements 110 and 112 are shown therein around the middle turbinate 106 and the inferior turbinate 108 in the implant deployed configuration, wherein the implants numbered 60, 80 or 90 are used for the cylindrical arrangement 110, and the implants numbered 10, 40 or 40' are used for the cylindrical arrangement 112. It can be seen that the implants 10, 40, 40', 60, 80 or 90 can be supported against the inner wall of the nasal cavity 100 while being arranged and fixed around the middle turbinate 106 and the inferior turbinate 108 through their longitudinal openings. This stable arrangement prevents the implants from being discharged through the nasal cavity 102 or passing through the nasal cavity 102. Fig. 7A The oropharynx 114 is shown being swallowed.
[0083] Now refer to Fig. 8A and 8B An insertion and deployment device 120 for inserting and deploying any of the above-described implants is described. Other known devices can be envisaged for inserting any of the above-described implants into a body cavity in the human or animal body and deploying it in a body cavity, in particular around the middle or inferior nasal concha of the nasal cavity. However, the device 120 has advantageous technical features for such an implant, in particular due to the cylindrical shape of the implant. However, the device 120 is still suitable for implants other than the above-described implants, in particular cylindrical implants without a longitudinal opening, the longitudinal opening resulting from the generally cylindrical wall being formed on the entire cylindrical side surface of the implant except in at least one limited angular portion of its circumference. In this case, the object constituted by the insertion device 120 and the object constituted by any of the above-described implants are independent of each other, although advantageously combined into the same medical assembly.
[0084] Respectively Fig. 8A The left and right portions of illustrative schematic diagrams schematically illustrate a non-limiting embodiment of an insertion and deployment device 120 in a first open configuration in side view and cross-sectional view.
[0085] More specifically, Fig. 8A A medical assembly for introducing an implant into a body cavity of a human or animal body is shown, comprising:
[0086] - any medical implant having a wall formed by an elastic structure, such as one of the above-mentioned implants, in particular implant 40 which is given by way of illustration only, and
[0087] - The insertion and deployment device 120 in its first, open configuration.
[0088] The device 120 comprises a generally cylindrical sleeve 122 having a proximal bore 124 for introducing any rod useful for ENT surgery, such as an endoscope 128, through the proximal end 126 of the sleeve 122. A partially threaded longitudinal bore 130 is made in the proximal end 126 around the longitudinal axis of the sleeve 122 to provide access to the bore 124 and to allow the placement of a cylindrical sealing ring 132 and the screwing in of a likewise threaded plug 134. In addition, radial bores 136 are made in the sleeve 122 to also provide access to the bore and, if necessary, to lock the longitudinal travel of the endoscope 128 using a pin (not shown).
[0089] The proximal channel 124 opens into a reamer 138 inside the sleeve 122, which extends to the distal end 140 of the sleeve 122. The reamer 138 accommodates the base of a button 142, which is actuable by a finger and slides along a groove 144 formed longitudinally in the wall of the sleeve 122. The reamer also accommodates a sliding hollow tube 146, which is integral with the base of the sliding button 142 and can be driven by the sliding button to translate along the longitudinal axis of the sleeve 122, which is also the insertion and deployment axis of the implant 40 in the human or animal body cavity.
[0090] The distal end 140 of the sleeve 122 is connected to a chamber 148 extending it along its longitudinal axis. This is a chamber 148 for receiving and radially contracting the implant 40 so that the central axis of the 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 fixing to the distal end 140 of the sleeve 122. The chamber has an opposite distal wall 152 for fixing to the tubular distal end 154 of the insertion device 120, through which the implant 40 is intended to be withdrawn so as to be introduced into the human or animal body cavity under consideration and to be deployed therein. The tubular distal end 154 has two longitudinal notches for forming a tongue 156, the free end of which is slightly bent toward the inside of the tube. Thus, the tongue 156 can be used as a guide when the implant 40 is withdrawn, accurately accommodated in the longitudinal opening produced by the limited angle portion 44 formed therein by the wall 42 of its circumference.
[0091] The chamber 148 is surrounded by a crimping element 158 which forms its side walls between two other walls, the proximal wall 150 and the distal wall 152. More precisely, the crimping element 158 comprises a plurality of flexible sheets, in particular five flexible sheets 160, 162, 164, 166 and 168, and a rigid sheet 170. These six sheets are arranged in a hexagonal shape to form a cylindrical chamber 148 with a hexagonal base around the implant 40. Each flexible sheet 160, 162, 164, 166 or 168 has two ends of smaller thickness, respectively integral with the proximal wall 150 and the distal wall 152 of the chamber 148, and a central portion comprising equally smaller thickness zones. These smaller thickness zones ensure its flexibility. As for the rigid piece 170, it has the same or similar length, but is integral with only one of the two walls, the proximal wall 150 and the distal wall 152, while being guided to slide in the other wall to allow the flexible piece to separate without twisting by virtue of its smaller thickness zone, thus allowing the chamber 148 to be opened so as to facilitate the introduction of the implant 40 therein. Fig. 8A The device 120 is shown in this open configuration of the chamber 148.
[0092] The longitudinal opening of the implant 40, which is produced by the fact that the wall 42 of its circumference has no limited angular portion 44 formed therein, should advantageously be placed against the rigid sheet 170. The rigid sheet 170 forms a reference mark for angularly placing the implant 40 around the longitudinal axis of the device 120. It therefore extends in a plane parallel to the plane of the base of the tongue 156. It also ensures a certain strength of the crimping element 158.
[0093] In a variant, it will be noted that the flexible crimping piece may be replaced by an equivalent crimping means, such as a mesh or stent-type braided structure.
[0094] The crimping element 158 also includes a retaining ring 172 for retaining the flexible sheets 160, 162, 164, 166 and 168 in the closed configuration of the chamber 148 so as to retain the implant in its radially contracted configuration. The retaining ring 172 is mounted to slide along and around the six sheets 160, 162, 164, 166, 168, 170.
[0095] Fig. 8A The left portion of is shows the retaining ring in a retracted position surrounding the distal wall 152 of the chamber 148 , thereby allowing the flexible sheets 160 , 162 , 164 , 166 , and 168 to separate and allow the implant 40 to be inserted into the chamber 148 .
[0096] Figure 8BThe left part of the embodiment shows the retaining ring in a crimped position around the central part of the flexible sheets 160, 162, 164, 166 and 168 by closing them. In this configuration, the chamber 148 is closed and the implant inside is radially contracted so that the central axis of the implant coincides with the insertion and deployment longitudinal axis 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 acting on the sliding button 142, the implant 40 can be pushed toward the distal end 154 of the device 120 through the sliding hollow tube 146 and then pushed outward, i.e. into the human or animal body cavity under consideration.
[0097] Now refer to Fig. 9 Describe the use Fig. 8A and Figure 8B Methods for inserting and deploying medical implants into body cavities of humans and animals.
[0098] In a first step 200, the insertion and deployment device 120 is in an open configuration. In other words, its chamber 148 is opened by placing the retaining ring 172 in its retracted position around the distal wall 152 and separating the flexible sheets 160, 162, 164, 166 and 168. The implant 10, 40, 40', 60, 80 or 90 is placed in the chamber 148, for example, loaded when the insertion and deployment device 120 is assembled.
[0099] In optional step 202, the sheet 174 can be introduced into the insertion and deployment device 120 from the distal end 154 of the device by passing under the tongue 156 and along the longitudinal opening of the implant or one of its longitudinal openings to the proximal end of the implant 10, 40, 40', 60, 80 or 90.
[0100] In the following step 204, the retaining ring 172 is placed by sliding in its crimping position around the central portion of the flexible sheets 160, 162, 164, 166 and 168 to close these flexible sheets around the implant 10, 40, 40', 60, 80 or 90 and close the chamber 148, which is then radially contracted.
[0101] In the following step 206, the implant 10, 40, 40', 60, 80 or 90 is pushed towards the distal end 154 of the insertion and deployment device 120 by acting on the slide button 142. The tab 174 helps the implant to place its longitudinal opening against the tongue 156. The tab can then be removed.
[0102] In the following 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 and deployment device 120 by acting on the sliding button 142, which is now in mid-travel.
[0103] Finally, in a final step 210 , when the slide button 142 is at the end of its travel, the implant 10 , 40 , 40 ′, 60 , 80 or 90 is completely introduced into the human or animal body cavity in question and can be deployed therein around the target biological protrusion.
[0104] It seems clear that a medical implant, such as one of the above described, is easy to manufacture industrially and is useful, particularly in ENT surgery, for placement around biological protrusions located in human or animal body cavities that may be difficult to access.
[0105] It also seems clear that the insertion and deployment device described above greatly facilitates the introduction of any of the above-described implants, or even other radially elastic cylindrical implants, into a human or animal body cavity that may be difficult to access for placement around a given biological protrusion.
[0106] It should also be noted that the present invention is not limited to the above-described embodiments. In fact, it will be clear to those skilled in the art that various modifications may be made to the above-described embodiments in accordance with the teachings just disclosed thereto. In the above detailed description of the present invention, the terms used should not be interpreted as limiting the present invention to the embodiments described in this specification, but should be interpreted as including all equivalent schemes, the provision of which is within the ability of those skilled in the art by applying the general knowledge of those skilled in the art to implement the teachings just disclosed thereto.
Claims
1. A medical implant (10; 40; 40'; 60; 80; 90) intended to be introduced into a body cavity (100) of a human or animal body, comprising at least one wall (12; 42; 62A, 62B; 92A, 92B), the at least one wall being formed by an elastic structure and intended to surround a biological protrusion (106, 108) present in the body cavity (100) in order to fix the medical implant around the biological protrusion, the at least one wall (12; 42; 62A, 62B; 92A, 92B) being substantially cylindrical and, except in at least one limited angular portion (14; 44; 64A, 64B) of the circumference of the medical implant, The medical implant (10; 40; 40'; 60; 80; 90) is characterized in that the at least one wall (12; 42; 62A, 62B; 92A, 92B) is at least one perforated wall, and is a structure having a solid peripheral frame (18) surrounding the at least one perforated wall and having a plurality of solid ribs (20, 22, 24) formed in the solid peripheral frame (18), or it is a radially elastic structure having a diamond grid, or it is a structure having a radially elastic structural element, the structural element having wavy tortuosity, so that the structural element itself is folded multiple times; thereby giving the medical implant (10; 40; 40'; 60; 80; 90) with a cylindrical side surface that is radially elastic.
2. The medical implant (10; 40; 40'; 60; 80; 90) according to claim 1, characterized in that The at least one wall (12; 42; 62A, 62B; 92A, 92B) is formed over the entire cylindrical side surface of the medical implant except over the entire length of the at least one limited angular portion (14; 44; 64A, 64B) of the circumference.
3. The medical implant according to claim 1 or 2 (10; 40; 60; 80; 90), including: - a distal end (26; 46; 66A, 66B), at which the at least one limited angle portion (14; 44; 64A, 64B) is open and free so that the biological protrusion (106, 108) can be engaged into the medical implant by sliding from the distal end; and - The proximal end (28; 48; 68A, 68B) has a stopper (30; 50; 70A, 70B) for limiting the biological protrusion (106, 108) from engaging into the medical implant until the stopper is reached.
4. The medical implant (40) according to any one of claims 1 to 3, comprising: - a distal end (26; 46; 66A, 66B), at which the at least one limited angle portion (14; 44; 64A, 64B) are open and free so that the biological protrusions (106, 108) can be engaged into the medical implant by sliding from the distal end; and - a plurality of elongated press plates (54A, 54B, 54C, 54D), in particular four elongated press plates, extending from the at least one wall (42) at the distal end (46) of the medical implant while being folded towards the interior of the at least one wall.
5. The medical implant (10; 40) according to any one of claims 1 to 4, comprising: proximal (28; 48; 68A, 68B, with a stopper (30; 50 ; 70A, 70B), used to limit the biological protrusion (106, 108) from being able to engage into the medical implant until it reaches the stopper; and a plurality of extensions (30A, 30B; 52A, 52B, 52C) extending from said at least one wall (12; 42) at the proximal end (28; 48) of the medical implant and shaped to form a bottom (30A, 30B; 52) of a stopper (30; 50) for said biological protrusion (106, 108) when said biological protrusion is engaged in the medical implant over the entire length of the limited angle portion (14; 44), in particular: - three extensions (52A, 52B, 52C), one of which is oval and the other two are kidney-shaped, all folded at right angles or nearly right angles toward the inside of the at least one wall (42); or - Two hook-shaped extensions (30A, 30B), whose hook bases are arranged symmetrically according to the symmetry plane of the medical implant centered on the limited angle portion (14; 44) and whose free hook ends are folded back into the limited angle portion (14).
6. The medical implant (10) according to any one of claims 1 to 5, comprising a single aperture wall (12), the single aperture wall being a radially elastic structure having a solid peripheral frame (18) surrounding the single aperture wall and having a plurality of solid ribs (20, 22, 24) formed in the solid peripheral frame (18), the single aperture wall (12) being formed on the entire cylindrical side surface of the medical implant (10) except in a single limited angular portion (14) of the circumference.
7. The medical implant (40; 40') according to any one of claims 1 to 5, comprising a single wall (42) of radially elastic structure having a rhombus grid, which is formed over the entire cylindrical side surface of the medical implant (40; 40') except in a single limited angular portion (44) of the circumference.
8. The medical implant (60; 80; 90) according to any one of claims 1 to 5, comprising two semi-cylindrical walls (62A, 62B; 92A, 92B), the semi-cylindrical walls having a radially elastic structural element, the structural element having wavy tortuosity so that the structural element folds itself multiple times, the two semi-cylindrical walls (62A, 62B; 92A, 92B) being formed facing each other over the entire cylindrical side surface of the medical implant (60; 80; 90) except in two limited angular portions (64A, 64B) of the circumference, wherein the two limited angular portions are radially opposite between the two semi-cylindrical walls (62A, 62B; 92A, 92B).
9. A method for inserting a medical implant (10; 40 ; 40'; 60; 80; 90) A medical component for introduction into a body cavity (100) of a human or animal body, comprising: - a medical implant (10; 40; 40'; 60; 80; 90) according to any one of claims 1 to 8; and - an insertion and deployment device (120) for inserting a medical implant (10; 40; 40'; 60; 80; 90) into a body cavity (100) of a human or animal body and for deploying it in the body cavity; The insertion and deployment device (120) comprises a chamber (148) for receiving and radially contracting a medical implant (10; 40; 40'; 60; 80; 90) so that the central axis of the radially contracted configuration of the medical implant coincides with the axis of inserting the medical implant into a body cavity of a human or animal body through the distal end (156) of the insertion and deployment device (120) and deploying the medical implant in the body cavity.
10. The medical assembly according to claim 9, comprising a crimping element (158) for crimping a medical implant (10; 40; 40'; 60; 80; 90), the crimping element having a retaining ring (172) for retaining the medical implant (10; 40; 40'; 60; 80; 90) in its radially contracted configuration, the retaining ring (172) being mounted around a cavity for receiving the medical implant (10; 40; 40'; 60; 80; 90) The chamber (148) slides between a retracted position, which is a position surrounding a proximal wall (150) or a distal wall (152) of a chamber (148) for receiving a medical implant (10; 40; 40'; 60; 80; 90) to allow the chamber to be opened, and a crimped position, which is a position surrounding a central portion of a chamber (148) for receiving a medical implant (10; 40; 40'; 60; 80; 90) to ensure that the chamber is at least partially closed.
Citation Information
Patent Citations
Implant for medical use intended to clip to a biological protuberance
WO2019025695A1