Detailed Description
Various exemplary embodiments of the present invention will now be described in detail with reference to the accompanying drawings. It should be noted that: the relative arrangement of the components and steps, the numerical expressions and numerical values set forth in these embodiments do not limit the scope of the present invention unless it is specifically stated otherwise.
The following description of at least one exemplary embodiment is merely illustrative in nature and is in no way intended to limit the invention, its application, or uses.
Techniques, methods, and apparatus known to one of ordinary skill in the relevant art may not be discussed in detail but are intended to be part of the specification where appropriate.
In all examples shown and discussed herein, any particular value should be construed as merely illustrative, and not limiting. Thus, other examples of the exemplary embodiments may have different values.
It should be noted that: like reference numbers and letters refer to like items in the following figures, and thus, once an item is defined in one figure, further discussion thereof is not required in subsequent figures.
According to an embodiment of the present disclosure, an ear-nose cavity support is provided, as shown in fig. 1 and 2, the ear-nose cavity support comprises at least two sub-supports 11;
the base material of the sub-stent 11 is degradable material, the sub-stent 11 is of a tubular structure, and the side wall of the tubular structure is of a latticed structure;
the at least two sub-supports 11 are sequentially stacked, and the degradation rates of the at least two sub-supports 11 are different.
In the embodiment of the present disclosure, the base material of at least two sub-stents 11 is degradable material, and the degradation rate of sub-stents 11 is different, so that each sub-stent 11 can be degraded in different time periods, and the degradation time of the ear-nose cavity stent can be adjusted by setting the degradation rate of the sub-stent 11, so as to meet the support time requirement of the ear-nose cavity stent, thereby ensuring the treatment effect.
The time period for which degradation of the sub-scaffolds 11 with different degradation rates is completed is different, and the degradation time of each sub-scaffold 11 can be controlled by setting the amount of material of each sub-scaffold 11. For example, each sub-stent 11 is set according to the requirement of degradation, so that at least two sub-stents 11 complete degradation in different time periods to meet the requirement of the support time of the ear-nasal stent.
The quantity of sub-support 11 can influence the structural strength of ear-nose cavity support, through the degradation rate that sets up every sub-support 11, makes ear-nose cavity support in the 11 degradation backs of different sub-supports, forms different structural strength to satisfy the demand of ear-nose cavity support to the structural strength that the ear-nose cavity supported.
In one embodiment, in two adjacent subscaffs 11, the rate of degradation of the subscaffs 11 located in the outer layer is greater than the rate of degradation of the subscaffs 11 located in the inner layer.
In this disclosed embodiment, it is bigger through the degradation rate that sets up outer sub-mount 11, when ear nasal cavity support set up in the ear nasal cavity, ear nasal cavity support can be followed the outmost degradation of accomplishing earlier to the medicine that sets up on the sub-mount 11 of inlayer can be exposed in the ear nasal cavity, thereby acts on the focus position of ear nasal cavity more easily.
In one embodiment, the base material of the submount 11 is a polylactic acid material or a magnesium alloy material.
In the embodiment of the present disclosure, the ear-nose cavity stent is formed into a combination of the sub-stents 11 of different materials by selecting a polylactic acid material or a magnesium alloy material.
For example, all of the sub-scaffolds 11 are polylactic acid materials. Alternatively, all the sub-brackets 11 are made of magnesium alloy material. Or, a part of the sub-stent 11 is made of polylactic acid material, and the other part of the sub-stent 11 is made of magnesium alloy material.
Alternatively, in the sub-stent 11 made of polylactic acid, the viscosity or density of each layer of the sub-stent 11 can be selected by those skilled in the art according to the requirement of the supporting time and the supporting strength of the ear-nasal stent, so as to form sub-stents with different degradation rates.
Optionally, the degradation rates of at least two of the sub-scaffolds 11 are different, and may be different for at least two of the sub-scaffolds 11.
In one embodiment, the outer sub-mount 11 is nested within the adjacent inner sub-mount 11.
In the embodiment of the present disclosure, the rate of degradation of the outer-layer sub-stent 11 is higher relative to the inner-layer sub-stent 11, so that the at least two sub-stents 11 exhibit a decreasing rate of degradation from the outer-layer to the inner-layer, such that the at least two sub-stents 11 can degrade layer by layer.
At least two of the sub-stents 11 form a stack of tubular structures and a sleeve-like structure.
For example, as shown in fig. 2, the first sub-scaffold 111, the second sub-scaffold 112, and the third sub-scaffold 113 are all sub-scaffolds 11, and correspond to the sub-scaffolds 11 with different degradation rates, respectively.
For example, in the process of assembling the ear-nose-cavity stent, the third sub-stent 113 of the innermost layer is first disposed, and then a different sub-stent 11 is molded on the outer side surface of the third sub-stent 113.
When the outer layer of the third sub-mount 113 further has multiple layers of sub-mounts 11, the sub-mounts 11 may be formed layer by layer, or the sub-mounts 11 may be sleeved outside the third sub-mount 113 after the sub-mounts 11 are formed.
For example, at least two of the sub-mounts 11 have a first sub-mount 111 and a second sub-mount 112. The first sub-mount 111 is sleeved outside the second sub-mount 112 to form a stacked structure in which the first sub-mount 111 is located at an outer layer of the second sub-mount 112.
When the ear-nose cavity bracket is used for treating the cavity of the ear-nose cavity, the ear-nose cavity bracket is placed at the focus position in the cavity of the ear-nose cavity, and the ear-nose cavity bracket supports the focus position.
Under the condition that the ear-nose cavity bracket supports the focus position, the bracket outer side surface 10 of the ear-nose cavity bracket is abutted with the inner wall of the cavity channel. The medicine on the ear-nose cavity support acts on the focus position, after the sub-support 11 on the outermost layer is degraded, the sub-support 11 on the second layer is exposed on the outermost side and supports the focus position, so that the medicine can act on the sub-focus position, and the treatment effect is guaranteed. In the process that the ear-nose cavity support is supported in the ear-nose cavity, along with the degradation of the sub-support 11, the support of the focus position can be kept, the medicine can be acted on the focus position, and the effect of the medicine administration treatment to the focus position is ensured. By selecting the number and degradation rate of each sub-stent 11, the lifespan of the ear-nose-cavity stent can be adjusted, thereby adjusting the supporting and administration time of the ear-nose-cavity stent to the lesion site.
For example, in fig. 1, the sub-mount 11 at the outermost layer of the ear-nose cavity mount is the first sub-mount 111, and the outer side surface of the first sub-mount 111 is the mount outer side surface 10. The inner layer of the first sub-mount 111 is the second sub-mount 112. The viscosity of the polylactic acid material of the first sub-stent 111 is less than that of the polylactic acid material of the second sub-stent 112, so that after the first sub-stent 111 is degraded, the second sub-stent 112 can still maintain the stent structure to support the cavity of the ear and the nasal cavity.
Alternatively, the inner layer of the second sub-mount 112 may also be provided with different sub-mounts 11 in sequence. For example, the inner layer of the second sub-mount 112 is also provided with a plurality of sub-mounts 11 in sequence.
For example, as shown in fig. 1 and fig. 2, the ear-nose-cavity support further includes a third sub-support 113, the third sub-support 113 is located at the innermost layer, and the material of the third sub-support 113 may be a magnesium alloy or a polylactic acid material.
In the case where the third sub-mount 113 is made of a magnesium alloy, the third sub-mount 113 can be restored to its original shape. The third sub-bracket 113 can make the ear-nose cavity bracket form effective support in the cavity channel of the ear-nose cavity.
For example, the third sub-mount 113 is sized to fit the size of the canal of the ear-nasal cavity. The ear-nose support is contracted before being placed in the ear-nose cavity. After the ear-nose cavity bracket is sent into the ear-nose cavity, the ear-nose cavity bracket is released and is restored at the focus position, so that the ear-nose cavity bracket forms a support at the focus position. This can help keep the ear-nose-cavity stent in support of the lesion site during degradation of at least two of the sub-stents 11.
The third sub-bracket 113 is made of memory alloy material, so that the third sub-bracket 113 has enough structural strength and can support the cavity in the ear-nose cavity, and the problems of support force reduction and support failure caused by insufficient structural strength of the ear-nose cavity bracket are avoided.
For example, the material of the third sub-mount 113 is aluminum magnesium alloy.
Optionally, the third sub-stent 113 is a degradable material. The material parameters of the third sub-stent 113 are set so that the degradation time of the third sub-stent 113 is after all the sub-stents 11, thereby ensuring the support of the third sub-stent 113 and enabling each sub-stent 11 to exert the effects of drug administration and support.
As shown in fig. 2, a submount 11 may be further disposed between the second submount 112 and the third submount 113, and the structure of a part of the submount 11 is omitted in fig. 2.
In one embodiment, the outer layer of the sub-mount 11 is wrapped around the inner layer of the grid-like structure of the sub-mount 11.
In the embodiment of the present disclosure, the structure of the outer layer of the sub-stent 11 is wrapped on the grid structure of the inner layer of the sub-stent 11, so that the grid structure of the sub-stent 11 is wrapped with the structure of at least one layer of the sub-stent 11.
For example, in FIG. 2, the sub-stent 11 is wrapped around the lattice structure of the third sub-stent 113 such that the third sub-stent 113 forms a covering for the sub-stent 11. The cross-section of the lattice-like structure of the third sub-stent 113 comprises the structure of the third sub-stent 113 at the middle position and the structure of the sub-stent 11 coated on the outer layer of the structure of the third sub-stent 113.
Optionally, the sub-mount 11 is formed by spraying.
In the embodiment of the present disclosure, the sub-mount 11 is molded by spraying. For example, the material of the sub-mount 11 is sprayed on the third sub-mount 113, so that the sub-mount 11 is molded on the outer layer of the third sub-mount 113.
In one embodiment, as shown in fig. 2, in the at least two sub-mounts 11, the sub-mount 11 at the innermost layer is made of a magnesium alloy material, and the other sub-mounts 11 are spray-molded on the sub-mount 11 at the innermost layer.
For example, the innermost sub-mount 11 is positioned at the third sub-mount 113. The third sub-mount 113 may be layered with the outer sub-mount 11 during the forming process. For example, by modulating different sprays to provide different viscosities for different shaped sub-stents 11. In the spraying process, the first sub-stent 11 is firstly sprayed and molded on the third sub-stent 113, and then the spraying material of the sub-stent 11 is replaced to form another sub-stent 11 with different viscosity on the outer layer of the sub-stent 11.
For example, the multi-layered submount 11 may be spray-molded on the outer side surface of the third submount 113. Alternatively, the third sub-frame 113 may be sprayed on the grid structure to form a plurality of layers of sub-frames 11 sequentially coated on the third sub-frame 113.
In one embodiment, the sub-stent 11 comprises a polylactic acid material and a drug, the polylactic acid material being mixed with the drug.
In the embodiment of the present disclosure, the polylactic acid material and the drug are mixed to form the sub-stent 11, and the drug in the sub-stent 11 can act on the lesion site in the case that the sub-stent 11 supports the lesion site. As the outer layer of the sub-stent 11 degrades, the inner layer of the sub-stent 11 is exposed and contacts the lesion site, thereby allowing the drug of the inner layer of the sub-stent 11 to also act on the lesion site.
In the process that multilayer sub-support 11 degrades one by one, every layer of sub-support 11 homoenergetic is enough for the medicine to act on the focus position to ensured the effect of dosing of otonasal cavity support, thereby ensured through this open otonasal cavity support to the treatment of ear nasal cavity treatment.
In one embodiment, the outer layers of the sub-stents 11 are all provided with drug-carrying layers for carrying drugs.
In the embodiment of the present disclosure, the drug-loaded layer is provided on the outer layer of the sub-stent 11 for applying drug to the lesion site. For example, the outer layer of each sub-stent 11 is provided with a drug-loaded layer. When the ear-nose cavity support supports the focus position, the medicine-carrying layer arranged on the outer layer of the sub-support 11 on the outermost layer is contacted with the focus position, so that medicine can be applied to the focus position for treatment. When the outermost sub-stent 11 is degraded, the drug-loaded layer of the inner sub-stent 11 is exposed and acts on the lesion site.
Alternatively, the drug-loaded layer may be formed by spraying the drug onto the sub-stent 11. The drug-loaded layer can also be a woven fabric layer arranged on the outer layer of the sub-stent 11, and the drugs are arranged in the woven fabric layer.
In one embodiment, the inner diameter dimension of the ear-nose cavity support is greater than or equal to the inner diameter dimension of the ear-nose cavity.
In the embodiment of the disclosure, the inner diameter of the ear-nose cavity bracket makes the radial dimension of the innermost sub-bracket 11 greater than or equal to the radial dimension of the ear-nose cavity, so that the ear-nose cavity bracket can form a support, and the problem that the ear-nose cavity bracket falls off from the ear-nose cavity is avoided.
For example, during the layer-by-layer degradation of the sub-stent 11, the overall radial dimension of the ear-nose cavity stent is shrinking. The radial dimension of the innermost sub-bracket 11 is larger than or equal to the radial dimension of the ear-nose cavity, so that the sub-bracket 11 can still support the ear-nose cavity under the condition of being degraded to the innermost sub-bracket 11, and the medicine of the sub-bracket 11 can act on the ear-nose cavity.
For example, in embodiments where a third sub-stent 113 is provided, the third sub-stent 113 is sized to support the expansion of the innermost sub-stent 11 and to have a radial dimension that is greater than the radial dimension of the ear-nose cavity.
For example, when the third sub-stent 113 returns to its original size configuration within the ear-nose cavity, both the multi-layered sub-stent 11 and the third sub-stent 113 expand. The structural strength of the third sub-mount 113 ensures that the ear-nose cavity mount can maintain the supporting strength in the degradation process, and also can maintain the supporting strength when degraded to the innermost sub-mount 11.
According to an embodiment of the present disclosure, there is provided a stent delivery device including an ear-nose stent as described in any one of the embodiments of the present disclosure.
In the embodiment of the present disclosure, after the ear-nose cavity stent is delivered into the ear-nose cavity by the stent delivery device, the ear-nose cavity stent needs to be expanded by using the balloon in the stent delivery device. After the ear-nose cavity stent is expanded, the supporting force of the undegraded stent 11 is reduced as the stent 11 is gradually degraded. The amount of deformation of the third sub-stent 113 of memory alloy material may be greater than the sub-stent 11 such that the radial dimension of the third sub-stent 113 is greater than the radial dimension of the sub-stent 11.
For example, the third sub-mount 113 is shaped into a deployed shape before implantation of the ear-nose mount. After the third sub-stent 113 is attached with the sub-stent 11 with the drug, the ear-nose cavity stent is compressed into the catheter of the stent conveying device and is conveyed to the focus by the catheter, and then the ear-nose cavity stent is pushed out of the catheter. The third sub-mount 113 is made of a magnesium alloy material and can be restored to a size before compression.
After the outer layer of the third sub-stent 113, the sub-stent 11 is degraded, the restorability of the magnesium alloy expands the third sub-stent 113, so that the drug-loaded sub-stent 11 can be always tightly attached to the inner wall of the ear and nasal cavity.
For example, drug residues may be present in the sub-stent 11 after degradation of the polylactic acid material in the sub-stent 11. After all the polylactic acid material in the sub-stent 11 is degraded, the third sub-stent 113 can still maintain a certain supporting force, so that the residual medicine can continuously act on the lesion.
When the third sub-stent 113 is shaped, the diameter of the third sub-stent 113 is shaped to be equal to or larger than the diameter of the lesion site of the ear and nose, so that the third sub-stent 113 can expand with the degradation of the polylactic acid in the sub-stent 11 made of the polylactic acid material, so that the third sub-stent 113 can always form an effective support.
In the above embodiments, the differences between the embodiments are described in emphasis, and different optimization features between the embodiments can be combined to form a better embodiment as long as the differences are not contradictory, and further description is omitted here in consideration of brevity of the text.
Although some specific embodiments of the present invention have been described in detail by way of examples, it should be understood by those skilled in the art that the above examples are for illustrative purposes only and are not intended to limit the scope of the present invention. It will be appreciated by those skilled in the art that modifications may be made to the above embodiments without departing from the scope and spirit of the invention. The scope of the invention is defined by the appended claims.