CN211300530U

CN211300530U - Eustachian tube absorbable metal stent and delivery system for implanting same

Info

Publication number: CN211300530U
Application number: CN201921269443.5U
Authority: CN
Inventors: 施超; 陈文文; 张炳昱
Original assignee: Suzhou Nanos Medical Devices Co ltd
Current assignee: Suzhou Nanos Medical Devices Co ltd
Priority date: 2019-08-07
Filing date: 2019-08-07
Publication date: 2020-08-21
Anticipated expiration: 2029-08-07

Abstract

The utility model relates to the field of medical equipment, a but auditory tube absorbs metal support and is used for implanting its conveying system is disclosed, including an annular support, the support cover can be established in the outside of a sacculus, and can be along with the expansion of sacculus and expansion, wherein, the peripheral range of support is around having many support rings, the support ring is the wave and can expand the deformation, and per two is adjacent all connect through one row of connecting rod between the support ring, and the support is made by human degradable material. The utility model provides a but eustachian tube absorbs metal support through the metal preparation support that uses the degradable absorption, has not only solved the expansion problem of narrow eustachian tube, has higher security simultaneously, than the difficult circumstances of acting on of eustachian tube to complicated pathological change in the current sacculus expansion technique, can gain outstanding effect more.

Description

Eustachian tube absorbable metal stent and delivery system for implanting same

Technical Field

The utility model relates to the field of medical equipment, in particular to auditory tube can absorb metal support and be used for implanting its conveying system.

Background

The middle ear adhesion is a disease causing conductive deafness of patients, which causes the auditory bones and tympanic membranes of the patients to adhere and fix, influences sound wave conduction and causes deafness; the main cause of the generation is eustachian tube obstruction, which further causes the occurrence of middle ear hypoventilation, middle ear negative pressure, exudation organization, adhesion and deafness. The tympanic membrane is used for incision and the middle ear air passage is built at home and abroad after the last 50-60 years, the negative pressure can be temporarily released, and the placed tube can be automatically discharged in about 3 months. When the eustachian tube is temporarily blocked, the tube can be used as a channel for temporarily replacing the eustachian tube, and the disease can still be cured even if the tube is automatically discharged along with the recovery of the function of the eustachian tube. However, if the obstruction caused by the real eustachian tube stenosis is met, the procedures of negative pressure, exudation and adhesion are automatically started again after the tympanic membrane intubation is discharged. Some experts implant a silica gel membrane in the middle ear cavity, but do not solve the problem of eustachian tube ventilation, so that middle ear adhesion cannot be avoided. Therefore, the adhesive otitis media is recognized by otorhinolaryngology scholars at home and abroad as one of the current most refractory diseases.

In the prior art, some technologies for solving the problem have been developed, for example, a titanium-nickel alloy eustachian tube support is used, but the titanium-nickel alloy eustachian tube support is made of a firm and non-absorbable material, and the re-blockage cannot be avoided when the titanium-nickel alloy eustachian tube support is left in the eustachian tube for a long time. For another example, when a eustachian tube expansion balloon is used, and a balloon expansion technology similar to cardiac coronary artery stenosis is used, the balloon is withdrawn after a eustachian tube cartilage segment is expanded and stays for a period of time, but the method only has a certain effect on early patients and cannot solve some serious lesions with large occupation ratio.

SUMMERY OF THE UTILITY MODEL

In order to solve the problem, the utility model provides a eustachian tube can absorb metal support and be used for implanting its conveying system.

According to an aspect of the utility model, a can absorb metal support of eustachian tube is provided, including an annular support, the support can overlap the outside of establishing a sacculus, and can be along with the expansion of sacculus expands, wherein, the peripheral range of support is around having many support rings, the support ring is the wave and can expand the deformation, and per two is adjacent all connect through one row of connecting rod between the support ring, and the support is made by human degradable material.

In some embodiments, the stent is made of a magnesium alloy. Therefore, the magnesium alloy is used for manufacturing the stent, not only can a good supporting effect be achieved through balloon expansion, but also the stent can be conveniently degraded in a human body.

In some embodiments, the scaffold has a length in the range of 10mm to 30mm and a diameter in the range of 1.5mm to 5 mm. Therefore, various size parameter ranges of the bracket are set, and the bracket can be selected according to requirements in actual processing.

In some embodiments, the surface of the stent is provided with a chemical coating and a polymeric coating. From this, through set up different coatings on the support, can realize the degradation cycle in the human body of the difference of support as required, set up the corrosion resisting property that chemical coating can improve magnesium alloy and reach the cohesion with the polymer coating, and set up the corrosion resisting property that the polymer coating can further improve the support.

In some embodiments, the chemical coating is a MgF2 coating or a calcium phosphate coating or a strontium phosphate coating. Therefore, several suitable components of the chemical coating are arranged, and can be selected according to actual requirements when being prepared.

In some embodiments, the polymer coating is formed by compounding one or more of polylactic acid, polylactic acid-glycolic acid copolymer, polycaprolactone, chitosan, polyvinyl acetate and polyethyleneimine, and the thickness of the polymer coating is 1-20 μm. Therefore, the parameters such as the components, the thickness and the like of the polymer coating are set, and the polymer coating can be compounded by selecting proper materials according to the requirement.

In some embodiments, the stent is loaded with a drug. Thus, inflammation and the like after the stent is implanted can be avoided.

According to one aspect of the present invention, there is provided a delivery system for implanting one of the above mentioned eustachian tube absorbable metal stents, comprising a hypotube, an inner tube and an outer tube, the hypotube being connected to one end of the outer tube, and one end of the inner tube being inserted into the other end of the outer tube; the balloon is fixedly arranged on the outer pipe and sleeved outside the inner pipe.

In some embodiments, the other end of the inner tube is provided with a tip. Thus, the balloon, stent, etc. can be introduced into the eustachian tube more smoothly by the tip first entering the affected part.

In some embodiments, the tip is snapped inside one end of a plastic hose and a metal guide wire is snapped inside the other end of the plastic hose. Thus, the use of plastic hoses and metal guide wires enables the implantation of balloons for patients with severe eustachian tube occlusion.

The beneficial effects of the utility model reside in that: through the metal preparation support that uses degradable absorption, not only solved the expansion problem of narrow eustachian tube, had higher security simultaneously, compared with the difficult circumstances that plays a role to the eustachian tube of complicated pathological change in the current sacculus expansion technique, can gain more outstanding effect. In addition, the utility model discloses still contained the conveying system that can treat eustachian tube pharyngeal opening shutting to form the material and the implantation technique that can solve severe, extremely severe eustachian tube problem comprehensively, provide more effective means for preventing and treating this world's difficult problem of adhesive otitis media, had obvious social or economic benefits.

Drawings

Fig. 1 is a schematic view of a structure related to an absorbable metal stent of a eustachian tube according to an embodiment of the present invention;

FIG. 2 is a schematic structural view of the stent shown in FIG. 1;

FIG. 3 is a schematic structural view of a delivery system for implanting the resorbable metal stent of the Eustachian tube shown in FIG. 1;

FIG. 4 is a schematic view of the balloon-related structure of FIG. 3 disposed in a sleeve;

fig. 5 is a schematic diagram of the balloon-related structure in fig. 3, provided with a plastic hose and a metal guide wire.

In the figure: the device comprises a support 1, a balloon 2, an inner tube 3, a hypotube 4, an outer tube 5, a tip 6, a tube sleeve 7, a plastic hose 8, a metal guide wire 9, a support ring 11 and a connecting rod 12.

Detailed Description

The present invention will be described in further detail with reference to the accompanying drawings.

Fig. 1 schematically shows a structure related to a eustachian tube absorbable metal stent according to an embodiment of the present invention, and fig. 2 shows the structure of the stent in fig. 1. As shown in fig. 1-2, the stent 1 comprises a ring-shaped stent 1, the stent 1 is sleeved outside a balloon 2, the balloon 2 is hollow and tubular, the width of the middle part of the balloon is larger than that of the two ends of the balloon, and the stent 1 is sleeved on the middle part of the balloon 2. An inner tube 3 is arranged in the balloon 2, and the balloon 2 can be inflated and expanded by introducing gas or liquid. The stent 1 is pressed on by a pressing device and can be expanded and deformed, when the balloon 2 is not expanded, the stent 1 is compressed, when the balloon 2 is inflated and expanded in volume, the stent 1 is deformed and expanded outwards by the action force of the expansion of the balloon 2, but after expansion, the stent 1 cannot be deformed and contracted under the action force of a human body.

A plurality of support rings 11 are arranged at the periphery of the bracket 1, and the support rings 11 are bent in a wave shape, surround the periphery of the bracket 1 for one circle and can expand and deform under stress; and the adjacent support rings 11 are connected through a row of connecting rods 12, so that the support rings 11 are connected in series through a plurality of rows of connecting rods 12. Wherein the extending direction of each connecting rod 12 is perpendicular to the extending direction of each support ring 11. In addition, the positions of two adjacent rows of connecting rods 12 are staggered, so that the expansion deformation of the supporting rings 11 can be not influenced while the supporting rings are stably supported.

Preferably, the length of the stent 1 is in the range of 10mm to 30mm, which can be selected according to the shape and size of the balloon 2, etc., and the diameter of the stent 1 is in the range of 1.5mm to 5mm, including the diameter size thereof when compressed and expanded.

The stent 1 is made of a material degradable by a human body, and the main material is a metal easily and safely degradable, preferably a magnesium alloy.

Preferably, since magnesium is active in metallic nature and the stent 1 is susceptible to corrosion using only magnesium alloys, a coating may be provided on the exterior of the magnesium alloy and the number of coatings may be more than one. Wherein, in order to improve the corrosion resistance of the magnesium alloy, a chemical coating can be coated on the surface of the bracket 1 by a chemical corrosion method, and in order to ensure that the adaptability of contacting with the human body is improved, a polymer coating can be further coated outside the chemical coating.

Preferably, the chemical coating is a MgF2 (magnesium fluoride) coating having a thickness of 1 μm to 20 μm. The chemical coating can be prepared by adopting a chemical corrosion method, which comprises the specific steps of directly putting the bracket 1 into a 40% HF solution for treatment for 36-72 hours, or putting the bracket 1 into a NaOH solution with the mass concentration of 100-200g/L for treatment for 1-10 hours, and then putting the bracket into the 40% HF solution for treatment for 36-72 hours, thus obtaining the MgF2 chemical coating.

Preferably, the chemical coating is a calcium phosphate coating or a strontium phosphate coating, and can be prepared by a chemical corrosion method, specifically, the bracket 1 is put into calcium dihydrogen phosphate or strontium dihydrogen phosphate solution, and the solution can contain other additives such as calcium fluoride and the like, and is treated at the temperature of room temperature to 100 ℃ for 1-72 hours, and then is put into NaOH solution with the mass concentration of 100g/L for treatment for 30-300 seconds, and is washed by absolute ethyl alcohol and dried, so that the calcium phosphate or strontium phosphate chemical coating can be obtained.

Preferably, the polymer coating is formed by compounding one or more of polylactic acid, polylactic acid-glycolic acid copolymer, polycaprolactone, chitosan, polyvinyl acetate and polyethyleneimine, and a proper coating can be selected according to needs in actual use, and the thickness of the polymer coating is also 1-20 μm.

Preferably, the polymer coating is applied by spray coating or dip coating. The specific method of the dipping and pulling method is that the stent 1 is dipped in the solution of the high polymer material for 5 to 30 minutes, and then the stent 1 is slowly pulled at the speed of 0.5 to 10cm/min, so that the high polymer coating can be formed on the surface of the stent 1. Although the spraying method is faster, the obtained organic coating is often thinner and not uniform enough, and the coating on the inner surface of the stent 1 is less, so the dipping and pulling method is often more effective.

Preferably, the stent 1 may be loaded with a drug, which is generally an anti-inflammatory drug, and may be selected from, but not limited to, mometasone furoate and dexamethasone, etc., in consideration of the possibility of an inflammatory condition occurring after the implant is implanted into a human body.

Fig. 3 shows the structure of a delivery system for implanting the eustachian tube absorbable metal stent of fig. 1, and fig. 4 shows the structure in which the balloon-related structure of fig. 3 is disposed in a tube sleeve. As shown in fig. 3-4, while the stent 1 is not shown in both figures in order to avoid clutter of the figure. The conveying system comprises a hypotube 4, an inner tube 3 and an outer tube 5, wherein the hypotube 4 is connected with one end of the outer tube 5, one end of the inner tube 3 is inserted into the other end of the outer tube 5, and a gap which is enough for gas or liquid to pass through is reserved between the inner tube 3 and the outer tube 5. Wherein, one end of the sacculus 2 is fixedly arranged at the tail end of the outer tube 5 by welding, and the inner tube 3 passes through the sacculus 2. Then, the balloon 2 is inflated with gas or liquid through the gap between the inner tube 3 and the outer tube 5 by using the hypotube 4 and the outer tube 5.

Preferably, in the case of a severely narrowed or even occluded pharyngeal orifice of the eustachian tube, and even when opened, it is often necessary to fixedly provide a tip 6 at the other end of the inner tube 3 after passing through the balloon 2, in order to facilitate the introduction of the catheter.

Preferably, when not in use, the balloon 2 and the associated stent 1, inner tube 3 and tip 6 are externally sheathed by a sheath 7 to isolate and protect them from contamination or damage by contact with the external environment.

When implanting the stent 1 and balloon 2 into the eustachian tube, the balloon 2 with the stent 1 is first mounted on the delivery system, with the inner tube 3 connected to the outer tube 5 and the tip 6 mounted at the end of the inner tube 3.

For patients with otitis media with non-perforated eardrum, etc., the balloon 2 of the delivery system is mounted on a manually operated pusher, etc. implant device and the tip 6 is introduced through the pharyngeal ostium and the device holder 1 and balloon 2 are then manipulated to be inserted into the eustachian tube and accurately positioned.

Fig. 5 shows the structure of the balloon-related structure of fig. 3 provided with a plastic hose and a metal guide wire. As shown in fig. 5, the tip 6 is snapped inside one end of the plastic tube 8 in the precise implantation positioning of the balloon 2 for a patient with a perforated eardrum, such as a patient with a severely narrowed or occluded eustachian tube. The plastic hose 8 has certain elasticity, the inner part of the plastic hose is narrow or is provided with narrow clamping structures in a distributed mode, the metal guide wire 9 can be clamped into the other end of the plastic hose 8, and the balloon 2 can be implanted by matching the plastic hose 8 and the metal guide wire 9.

The specific implantation method comprises the following steps: inserting the metal guide wire 9 into the plastic hose 8, enabling the whole body to enter from the tympanic opening until the pharyngeal opening comes out, clamping the whole body from the nasal cavity by using a nose clamp, and pulling out the metal guide wire 9 from the plastic hose 8; the tip 6 of the delivery system carrying the stent 1 is then snapped into the other end of the plastic tube 8 and the plastic tube 8 is pulled, so that the balloon 2 and stent 1 on the delivery system can be pulled into the eustachian tube and accurately positioned.

The saccule 2 is inflated to expand the saccule, the stent 1 sleeved outside the saccule expands along with the saccule and keeps for 2 minutes, then the saccule 2 is pumped out or pumped out to contract the saccule, and the stent 1 still maintains the expanded state; and then the balloon 2 is pumped out by operating the instrument, so that the expanded stent 1 can be left in the eustachian tube, and the effect of expanding and ventilating the eustachian tube is achieved. The stent 1 can be gradually degraded in a human body, and can be completely degraded and disappear after 10 to 180 days according to needs without trying to take out.

Therefore, the utility model provides a eustachian tube can absorb metal support has metal material's extending characteristics, has solved the expansion problem of narrow eustachian tube, has simultaneously can absorb function and higher security, and than the difficult circumstances of acting on of eustachian tube to complicated pathological change in the current sacculus expansion technique, can gain outstanding effect more. In addition, the utility model discloses still contained the conveying system that can treat eustachian tube pharyngeal opening shutting to form the material and the implantation technique that can solve severe, extremely severe eustachian tube problem comprehensively, provide more effective means for preventing and treating this world's difficult problem of adhesive otitis media, had obvious social or economic benefits.

What has been described above are only some embodiments of the invention. For those skilled in the art, without departing from the inventive concept, several modifications and improvements can be made, which are within the scope of the invention.

Claims

1. The absorbable metal stent of eustachian tube, its characterized in that: the stent comprises an annular stent (1), wherein the stent (1) can be sleeved outside a balloon (2) and can expand along with the expansion of the balloon (2), a plurality of support rings (11) are arranged around the periphery of the stent (1), the support rings (11) are wavy and can expand and deform, every two adjacent support rings (11) are connected through a row of connecting rods (12), and the stent (1) is made of a human degradable material.

2. The eustachian tube absorbable metal stent of claim 1, wherein: the bracket (1) is made of magnesium alloy.

3. The eustachian tube absorbable metal stent of claim 1, wherein: the length range of the bracket (1) is 10mm-30mm, and the diameter range is 1.5mm-5 mm.

4. The eustachian tube absorbable metal stent of claim 1, wherein: the surface of the bracket (1) is provided with a layer of chemical coating and a layer of polymer coating.

5. The eustachian tube absorbable metal stent of claim 4, wherein: the chemical coating is an MgF2 coating or a calcium phosphate coating or a strontium phosphate coating.

6. The eustachian tube absorbable metal stent of claim 1, wherein: the bracket (1) is loaded with drugs.

7. A delivery system for implanting a eustachian tube absorbable metal stent according to any one of claims 1 to 6, characterized in that: the device comprises a hypotube (4), an inner tube (3) and an outer tube (5), wherein the hypotube (4) is connected with one end of the outer tube (5), and one end of the inner tube (3) is inserted into the other end of the outer tube (5); the balloon (2) is fixedly arranged on the outer pipe (5) and sleeved outside the inner pipe (3).

8. The delivery system of claim 7, wherein: the other end of the inner tube (3) is provided with a tip (6).

9. The delivery system of claim 8, wherein: the tip (6) is clamped into one end of a plastic hose (8), and a metal guide wire (9) is clamped into the other end of the plastic hose (8).