Tympanostomy tube

Abstract

A fluid bridging tube (1) for bridging a membrane in a human or animal body to allow fluid passage has a proximal flange (2), an interluminal connector (3) having a lumen (5), and a distal flange (4). The tube includes a metal frame or scaffold structure (51) and a surrounding polymer that is more flexible than the scaffold structure. The scaffold structure (51) has a tubular mesh that provides structural strength to the interluminal connector. The tubular mesh has members (61) that define a substantially rectangular mesh opening and a distal crown (64). At its proximal end, the scaffold structure includes a ridge (68) that extends from a proximal tubular mesh edge (63). The ridge provides structural strength to the proximal flange (2). In a preferred embodiment, the tube is a tympanostomy tube. A method of making the tube includes providing a scaffold structure and overmolding an outer material to form the shape of the proximal flange, the interluminal connector having a lumen, and the distal flange.

Description

Technical Field

[0001] This invention relates to tympanic membrane perforation tubes and other tubes for allowing intracorporeal fluid to pass through a wall or membrane having properties substantially similar to the tympanic membrane. Examples are tubes for bridging membranes within the body, such as eye drainage devices. Background Technology

[0002] WO2019 / 086608 (AventaMed Designated Activity Company) describes a tympanic duct and placement device. The duct has a proximal flange that acts as a stop or depth sensor during placement, an intercavity connector for allowing fluid to pass through the tympanic membrane, and a distal flange that is folded during deployment and unfolds when located on the distal side of the membrane. In this case, and for many other placement methods, it is ideal for the distal flange to be more flexible than the proximal flange to achieve efficient deployment.

[0003] The present invention aims to provide a tympanic cavity tube with improved flexibility and strength properties for deployment and use. Summary of the Invention

[0004] We describe the fluid bridge fitting as described in the appended claims 1 to 17, and the manufacturing method as described in claim 18.

[0005] In addition, we describe a fluid bridge tube for human or animal, the tube comprising a proximal flange, an intercavity connector having cavities, and a distal flange, wherein the tube includes a support structure and an outer material that is softer than the support structure and completely or partially surrounds the support structure.

[0006] Preferably, the tube is a tympanic membrane endoscopic tube.

[0007] Preferably, the support structure includes a tubular mesh extending through at least some of the inter-cavity connectors. Preferably, the tubular mesh has members defining substantially curved rectangular mesh openings, which optionally have substantially equal sides. Preferably, the tubular mesh includes a crown at its distal end.

[0008] Preferably, the tubular mesh includes an edge without holes at its proximal end.

[0009] Preferably, the support structure includes radially extending ridges to provide structural support for at least the proximal flange. Preferably, the support structure includes radially substantially equidistant ridges.

[0010] Preferably, the support structure comprises a material selected from stainless steel, nitinol, titanium, or polymers.

[0011] Preferably, the external material includes medical-grade silicone rubber.

[0012] Preferably, the external material is overlaid onto the support structure.

[0013] Preferably, the support structure is completely surrounded (encapsulated) by an external material.

[0014] Preferably, the distal flange does not include any part of the support structure.

[0015] We also describe a method for manufacturing a fluid bridge connector of any example described herein, the method comprising: providing a support structure; and overmolding an external material to form the shape of a proximal flange, an inter-cavity connector having cavities, and a distal flange. Attached Figure Description

[0016] The present invention will be more clearly understood from the following description of some embodiments thereof, which are given by way of example only with reference to the accompanying drawings, wherein:

[0017] Figure 1 This is a 3D view of the tympanic membrane endoscopic tube;

[0018] Figure 2 It is a schematic diagram using dashed lines to represent the internal structure;

[0019] Figure 3 It is a three-dimensional diagram of the pipe's support or frame structure; and

[0020] Figure 4 and 5 It is a cross-sectional view showing the support structure and the overmolded parts. Detailed Implementation

[0021] Reference Figure 1 The tympanic membrane endoscopic tube 1 includes:

[0022] -Proximal flange 2,

[0023] -The inter-cavity connector 3 that forms cavity 5, and

[0024] -Distal flange 4.

[0025] The proximal flange 2 has four equally spaced through holes for accommodating the retainer fingers of the device, aligned with the protrusions 20 of the distal flange 4. In other examples, there may be different numbers and / or spacings of through holes and associated protrusions in the distal flange. The holes 10 have a curved outer surface and a circumferentially curved inner surface 12. Each protrusion 20 has a radial portion 21 and an axial portion 22, the latter forming an acute angle of approximately 10° with the longitudinal axis of the tube 1. The longitudinal axis is the central axis of the cavity 5.

[0026] The tube 1 is deployed in the manner described in WO2019 / 086608, implemented by a placement device having longitudinal fingers that extend through the hole 10 and press radially inward against the distal flange 4, more specifically against the protrusion 20 having a radial portion 21 and an axial portion 22. When the needle of the placement device pierces the tympanic membrane, the proximal flange acts as a stop or depth sensor for the device from the tympanic membrane, contacting or nearly contacting the tympanic membrane with its distally facing surface. The placement device retainer fingers and needle are then retracted, causing the protrusion 20 of the distal flange 4 to pop out. Figure 1 The radial position shown indicates that tube 1 is fixed in place by passing through the membrane.

[0027] like Figure 2 As shown, the tube 1 comprises an internal frame or support structure 51 of metal (or, in other examples, a suitable rigid material, such as a rigid polymer) and a softer surrounding external material 50.

[0028] In this case, the support structure 51 is made of stainless steel and the surrounding outer material 50 is a silicone-coated molded part. In other examples, the frame may include titanium or other suitable materials, which are also more rigid than the outer material.

[0029] The outer material 50 is preferably overmolded, and it preferably comprises a polymer of a material that is more elastic and less rigid than the scaffold. In this example, the overmolded material is a medical-grade liquid silicone rubber, preferably having a Shore A hardness in the range of 50 to 90.

[0030] like Figure 3 As shown, the support structure 51 includes a tubular mesh 60, which includes an integral structural member 61 defining a curved rectangular aperture 62. The proximal end of the tubular mesh 60 has higher strength, forming an aperture-free edge 63. The distal end of the tubular mesh 60 includes a distally facing crown 64 formed by a distal member 64.

[0031] At the proximal end, there are four metallic ridges 68, which extend radially from the edge 63 at equal 90° radial intervals. The ridges 68 are integral with the tubular mesh 60.

[0032] The tube is manufactured using known techniques for manufacturing stents. One example is laser-cutting a pattern followed by folding and welding. Another example is laser-cutting from a tube with the correct inner diameter (ID) and wall thickness, followed by forming the legs after the component is manufactured. The silicone 50 is then overmolded by injection molding. The inner stent is placed and held in place in a mold, and the silicone is injection-molded overmolded onto the stent. Overmolding 50 in… Figure 4 and 5 It is shown in more detail below.

[0033] The manufactured tube 1 exhibits excellent strength and flexibility properties, with the proximal flange 2 possessing greater stiffness than the distal flange 4 due to the metal ridge 68. The intercavity connector 3 possesses excellent strength to remain open during deployment and throughout its service life after insertion; in one example, its service life may be up to approximately two years, but in another, it may be permanent. The distal crown 64 allows for a distal configuration that facilitates insertion through the tympanic membrane with minimal resistance.

[0034] Tube 1 has a rigid structure, which, in addition to the distal flange 4 with post 20, allows for efficient installation into the tube delivery system, ideally providing a folded narrow inlet for the distal flange. The rigid cavity and proximal flange allow for tube deployment without tube collapse or deformation. Within the tube, the support structure ensures that the cavity remains intact throughout the device's service life, whereas a fully silicone tube might kink or collapse due to external forces acting upon it.

[0035] Clinical benefits

[0036] The silicone material comes into contact with the body, while the tube has the rigidity of a lower layer made of a harder material (fluoroplastic, titanium, or metal).

[0037] The support structure ensures that the cavity will not collapse inside the body, thereby reducing the risk of tube blockage during use.

[0038] The support structure provides rigidity to the proximal flange. While the diameter of the distal flange of a tympanic cavity tube is known to affect the tube extrusion rate, it is also known that the proximal flange affects the extrusion rate because the natural growth of the tympanic membrane pushes the proximal flange, causing the tube to be extruded from the tympanic membrane over time. Unlike the tube described here, if a more flexible outer (proximal) flange is used, this could impair the body's ability to extrude the tube in a timely manner, as the flexible proximal flange would deform rather than be extruded from the tympanic membrane.

[0039] The more flexible distal flange and flange spacing allow for easy placement of the tube, even in a retracted eardrum, as the distal (inner) flange deforms and opens, engaging with the inner side of the tympanic membrane and being precisely deployed in the incision.

[0040] The mechanical properties of tubing with silicone and stainless steel interiors allow for flexibility in manufacturing tubing with other tubing configurations, such as T-tubes, which can be included in the device as an alternative tubing option for clinicians. Typically, T-tubes have a very large distal (internal) flange (e.g., approximately 10 mm) and remain in the body for more than 2 years, and in some cases indefinitely.

[0041] Color can be easily added to silicone materials—for example, blue allows clinicians to easily see the outer flange of the tube during placement, resulting in more accurate placement. Postoperatively, clinicians can more easily see the tube in place, which is often difficult when examining pediatric ears, especially in patients with small ears or those who are mobile.

[0042] If the tube cannot be expelled naturally, it must be removed surgically. The inner flange of the silicone tube is flexible, making removal potentially easier and less traumatic to the tympanic membrane if necessary. This may result in a lower perforation rate.

[0043] This invention is not limited to the described embodiments, but can be varied in structure and details. It is conceivable that the tubular mesh structure members can have smaller or larger cross-sectional areas, depending on clinical requirements. In some cases, ridges may be present for the distal flange, and, if present, they may be more flexible than ridges for the proximal flange, for example, having a smaller cross-sectional area. Any desired number of ridges may be present for the proximal flange and for the distal flange (if they are present). The volume of the outer material is selected to ensure that the stent does not protrude during use, and of course, according to other clinical requirements.

[0044] As described above, this tube can be used for other in vivo medical applications, such as fluid transfer between two biological structures separated by a membrane. However, it is particularly preferred for use with the tympanic membrane.

[0045] This tube, which may be referred to as a fluid bridging tube, is used to transport any fluid, gas, or liquid, including air for ventilation. Furthermore, the support structure can be configured to expand during deployment, either by self-expanding using a shape-memory support material such as nitinol, or by expanding by applying internal pressure using, for example, a balloon.

[0046] Furthermore, it is conceivable that the external material is not overmolded, and instead, the support structure can be embedded in the external material by, for example, press-fitting the support structure into a tubular or sleeve-shaped body. Additionally, it is conceivable that the external material does not completely surround the support structure.

[0047] It is conceivable that the tube and stent can be manufactured in a collapsed state. In one embodiment, the stent material may be made of stainless steel or titanium, which will utilize a mechanism that expands from within, for example, an inflatable balloon, during tube deployment. In another embodiment, the stent material may be made of a metal with shape memory properties, which expands once released from the device's holding component. In both embodiments, the silicone overmolded component will expand as the stent expands to a new, larger size. These embodiments allow for a lower profile of the device, which will improve the ability to puncture the eardrum during deployment and the visibility of the device. In other examples, the flexible silicone material may be a suitable medical-grade flexible material, such as a thermoplastic elastomer, "TPE".

Claims

1. A fluid bridging connector (1) for humans or animals, the connector comprising a proximal flange (2), an inter-cavity connector (3) having cavities (5), and a distal flange (4), wherein the connector at least partially comprises a support structure (51) and an outer material (50) softer than the support structure and completely or partially surrounding the support structure, the support structure (51) comprising a tubular mesh extending through at least some of the inter-cavity connectors, in, The tubular mesh includes a perforated edge (63) at its proximal end. Wherein, the distal flange (4) does not include any part of the support structure. Wherein, the tube is a tympanic membrane perforation tube, and The tubular mesh includes a component (61) that defines a substantially curved rectangular mesh opening.

2. The fluid bridge connector according to claim 1, characterized in that, The mesh has substantially equal sides.

3. The fluid bridge connector according to claim 1, characterized in that, The tubular network includes a crown (64) at its distal end.

4. The fluid bridge connector according to claim 1, characterized in that, The support structure includes a ridge (68) that extends radially to provide structural support for at least the proximal flange (2).

5. The fluid bridge connector according to claim 4, characterized in that, The support structure includes radially equidistant ridges (68).

6. The fluid bridge fitting according to any one of claims 1 to 4, characterized in that, The support structure comprises materials selected from stainless steel, nickel-titanium, titanium, or polymers.

7. The fluid bridge fitting according to any one of claims 1 to 4, characterized in that, The external material includes medical-grade flexible material.

8. The fluid bridge connector according to claim 7, characterized in that, The medical-grade flexible material is silicone rubber.

9. The fluid bridge fitting according to any one of claims 1 to 4, characterized in that, The external material (50) is coated onto the support structure.

10. The fluid bridge fitting according to any one of claims 1 to 4, characterized in that, The support structure is completely surrounded by the external material.

11. The fluid bridge fitting according to any one of claims 1 to 4, characterized in that, The support structure can expand radially from the inside.

12. The fluid bridge connector according to claim 11, characterized in that, The stent structure can be radially expanded from the inside by a balloon, and the external material is configured to expand as the stent structure expands.

13. The fluid bridge fitting according to any one of claims 1 to 4, characterized in that, The support structure includes a shape memory material configured to expand from the retaining component, and the external material is configured to expand as the support structure expands.

14. A method for manufacturing a fluid bridge nozzle according to any preceding claim, the method comprising: Provide the aforementioned support structure; And the outer material is overmolded to form the shape of the proximal flange (2), the cavity connector (3) having a cavity (5), and the distal flange (4).

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