Detailed Description
The implantable medical device provided by the utility model is clearly and completely described below with reference to the accompanying drawings. It is to be understood that the described embodiments are merely some, but not all embodiments of the utility model that may be practiced otherwise than as described herein.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this utility model belongs. The terminology used in the description presented herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the utility model.
It should be noted that all the directional indicators in the embodiments of the present specification are only used to explain the relative positional relationship, movement conditions, etc. between the components in a certain posture, and if the certain posture is changed, the directional indicators are changed accordingly.
Furthermore, descriptions such as those referred to as "first," "second," and the like, are provided for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implying an order of magnitude of the indicated technical features in the present disclosure. Thus, a feature defining "a first" or "a second" may explicitly or implicitly include at least one such feature. In the description of the present specification, the meaning of "plurality" means at least two, for example, two, three, etc., unless explicitly defined otherwise.
The technical solutions of the various embodiments of the present utility model may be combined with each other, but it is necessary to base the implementation of those skilled in the art, and when the combination of the technical solutions contradicts or cannot be implemented, it should be considered that the combination of the technical solutions does not exist, and is not within the scope of protection claimed by the present utility model.
In this specification, axial refers to a direction parallel to the line connecting the distal center and the proximal center of the assembly, and radial refers to a direction perpendicular to the axial direction.
Fig. 1 to 3 show a first embodiment of an implanted medical device 100 according to the present utility model, in this embodiment, the implanted medical device 100 is a tracheal stent, including a support skeleton with a plurality of hollows 8 and a plurality of microneedles 3, each microneedle 3 includes a connection layer 31 and a first drug-carrying spike 32, the connection layer 31 is respectively connected with the support skeleton and the first drug-carrying spike 32, and the hardness of the connection layer 31 is greater than that of the first drug-carrying spike 32.
In other embodiments, the support frame is used to support the lumen of the human body to prevent stenosis, and may be an intraluminal implant, or other implants, such as a one-way valve product used in a lung volume reduction procedure, and the like.
Preferably, the supporting framework is preferably a tubular structure, such as a cylindrical structure, an elliptic cylindrical structure, a frustum structure, etc., in this embodiment, the supporting framework is preferably cylindrical, and in other embodiments, the supporting framework may also be a combination of one or more of the above structures.
Preferably, the supporting framework comprises at least two wave rings 1 and a connecting rod 2 for connecting the two wave rings 1. The connecting rod 2 is located between two adjacent wave rings 1, the wave rings 1 are formed by Z-shaped waves, and can also be made of other structures, which are not described herein. Further, one end of the connecting rod 2 is fixedly connected with the wave ring 1 positioned at one end of the connecting rod, and the other end of the connecting rod 2 is fixedly connected with the wave ring 1 positioned at the other end of the connecting rod, so that the connecting and fixing functions are realized on two adjacent wave rings 1. The wave ring 1 and the connecting rod 2 can be welded and fixed with each other, can be integrally formed, and the like, and are not described herein.
Furthermore, the wave ring 1 and/or the connecting rod 2 are made of a biocompatible material, such as nickel-titanium alloy, iron, magnesium alloy, stainless steel, polylactic acid, etc., which can be selectively set according to the needs, so that the description thereof is omitted.
In some preferred embodiments, as shown in fig. 3, the connection layer 31 is plate-shaped, and the connection layer 31 is attached to the surface of the supporting framework, specifically, the connection layer 31 is attached to the surface of the wave ring 1 or the surface of the connecting rod 2, so that the connection layer 31 can be firmly and fixedly connected with the wave ring 1 or the connecting rod 2, such as adhesion and fixation, and meanwhile, the hardness of the connection layer 31 is greater than that of the first medicine carrying spike 32, so that the first medicine carrying spike 32 is stably supported and fixed, and the first medicine carrying spike 32 is prevented from being broken.
Further, the connection layer 31 is located between the first medicine carrying spike 32 and the supporting framework, one end of the connection layer 31 is fixedly connected with the supporting framework, such as adhesion and fixation, and the other end of the connection layer 31 is fixedly connected with the first medicine carrying spike 32, such as adhesion and fixation, so that the first medicine carrying spike 32 is firmly connected with the supporting framework, the hardness of the connection layer 31 is greater than that of the first medicine carrying spike 32, and the connection layer 31 can play a firm supporting role on the first medicine carrying spike 32, prevent the first medicine carrying spike 32 from breaking, enable the first medicine carrying spike 32 to stably penetrate into tissues, and ensure the stability and the treatment effect of the structure.
Specifically, one end of the connecting layer 31 is fixedly connected with the supporting framework, that is, the connecting layer 31 is fixedly connected with the wave ring 1, or the connecting layer 31 is fixedly connected with the connecting rod 2, so that the micro needle 3 can be fixed at a required position on the supporting framework, such as a lesion position or a position needing to be fixed, and the like.
Preferably, the connection layer 31 is made of a stable and non-degradable material, such as a metallic material or a non-degradable nonmetallic material, etc., and is preferably made of one or more of PVPK90 (povidone), PEEK (polyetheretherketone), PMMA (polymethyl methacrylate), and PTFE (polytetrafluoroethylene). The connection layer 31 may also be made of a multi-layer structure, and each layer is made of one of the above materials, so as to satisfy different structural and strength requirements of the connection layer 31.
Further, the first drug-carrying spike 32 is preferably a degradable material, so that the first drug-carrying spike 32 can be degraded in the tissue after penetrating into the tissue, and further, the drug in the first drug-carrying spike 32 can be released into the tissue, so that the tissue can be treated, and the occurrence of conditions such as intimal hyperplasia and the like of the tissue can be prevented.
In a preferred embodiment, the plurality of connection layers 31 are distributed on the outer surface of the support frame, which is the surface of the support frame that contacts the inner wall of the body lumen or the like after implantation thereof. The supporting framework is provided with a central axis X, one end of the first medicine carrying pointed body 32, which is close to the supporting framework, is a proximal end, and one end of the first medicine carrying pointed body 32, which is far away from the supporting framework, is a distal end, and the sectional area of the distal end of the first medicine carrying pointed body 32 is smaller than that of the proximal end of the first medicine carrying pointed body 32, so that the first medicine carrying pointed body 32 can penetrate into tissues. Further, the first drug-carrying spike 32 is preferably a cone, or may be a polygonal cone, etc., and the shape of the first drug-carrying spike 32 may be selected according to need, which is not described herein.
In some preferred embodiments, as shown in fig. 4, the connecting layer 31 is in a closed ring shape or an unsealed arc shape, and passes through two adjacent hollow parts 8 to wrap on the supporting framework, so as to further enhance the stability effect of the connection between the microneedle 3 and the supporting framework, specifically, the connecting layer 31 wraps on the wave ring 1 or the connecting rod 2, so that the first drug-carrying spike body 32 can be fixed at a required position on the supporting framework, so as to treat or fix a required position.
More preferably, the connecting layer 31 surrounds the supporting skeleton in cooperation with the first drug carrying spike 32, such as around the wave ring 1, around the connecting rod 2, or around both the wave ring 1 and the connecting rod 2. The connecting layer 31 and the first medicine carrying spike body 32 cooperatively encircle the supporting framework, specifically, a part or all of the connecting layer 31 and a part of the first medicine carrying spike body 32 form an annular cladding body to encircle the supporting framework, so that the stable connection between the micro needle 3 and the supporting framework can be realized, the micro needle 3 and the supporting framework are prevented from being separated, the micro needle 3 can smoothly penetrate into tissues, and the effects of treating diseases and fixing are achieved.
In some preferred embodiments, as shown in fig. 5, each microneedle 3 further comprises a protrusion 311, and the first drug carrying spike 32 encloses the protrusion 311, wherein the protrusion 311 is located on at least part of the surface of the connection layer 31.
In this embodiment, the cross section of the protruding portion 311 is triangular, the protruding portion 311 and the connecting layer 31 may be integrally formed, or the protruding portion 311 may be fixed on the connecting layer 31, such as adhesive fixing. The first medicine carrying spike 32 is in a needle tip shape, and the first medicine carrying spike 32 is coated on the outer surface of the protruding portion 311, so that the first medicine carrying spike 32 can be firmly fixed on the connecting layer 31.
In other embodiments, the protrusions 311 cooperatively encapsulate the support frame with the connection layer 31. The part of the protruding part 311 and the part of the connecting layer 31 together form an annular cladding body to cover the supporting framework, so that the micro-needles 3 can be firmly fixed on the supporting framework, and the fixing effect is obvious.
In some preferred embodiments, as shown in fig. 6, each microneedle 3 further comprises a water-soluble separation layer 33 disposed between the connecting layer 31 and the first drug carrying spike 32.
Specifically, the water-soluble separation layer 33 is made of a material that is easy to separate, preferably a water-soluble adhesive, such as polyethylene glycol hydrogel, so that the material can be quickly dissolved after encountering a liquid, such as water, to separate the first drug-carrying spike 32 from the connection layer 31, or a material that is composed of hyaluronic acid and sucrose, wherein the mass ratio of hyaluronic acid to sucrose is 4:1, and the material can also play a role in separation.
In particular, the provision of the separation layer 33 may serve a specific separation function, such as withdrawing the implanted medical device 100 or the like, and may only dissolve after the separation layer 33 is in contact with water or the like to effect separation of the connection layer 31 from the first drug carrying spike 32.
In some preferred embodiments, as shown in fig. 7, the connection layer 31 has a first coating portion 312, the first coating portion 312 coats the side surface of the first drug-carrying spike 32, and the first coating portion 312 exposes the tip of the first drug-carrying spike 32.
Specifically, the first coating portion 312 may be provided with one or more, and when the first coating portion 312 is provided with one, the first coating portion 312 is plate-shaped, and the first coating portion 312 is located at one side of the first drug-carrying spike body 32, when the first coating portion 312 is provided with two, the first coating portion 312 is located at two sides or two opposite sides of the first drug-carrying spike body 32, and when the first coating portion 312 is provided with a plurality of first coating portions 312, the first coating portion 312 is located at a plurality of sides or other sides of the first drug-carrying spike body 32, and may be provided at corresponding positions as required.
More specifically, the first coating portion 312 may also be formed into a ring shape and wrapped around the end portion of the first drug-carrying spike 32 near the supporting frame, so as to fully wrap the end portion of the first drug-carrying spike 32, so as to firmly fix the first drug-carrying spike 32 on the supporting frame, and support the first drug-carrying spike 32, and meanwhile, the size of the first drug-carrying spike 32 is designed to be smaller so as to more conveniently penetrate into tissues, thereby reducing cost and alleviating pain of patients.
In this embodiment, the first coating portion 312 is provided with two and is located at two sides of the first drug-carrying spike body 32, the first coating portion 312 is preferably plate-shaped, and the first coating portion 312 is attached to a side surface of the first drug-carrying spike body 32, so as to be beneficial to fixing the first drug-carrying spike body 32, enhancing the stability of connection between the first drug-carrying spike body 32 and the connection layer 31, and the first coating portion 312 and the first drug-carrying spike body 32 can be fixed or connected in an adhesive manner, or in other embodiments, the first coating portion 312 can be formed or fixed on the support skeleton, and then the first drug-carrying spike body 32 is molded under the cooperation of the first coating portion 312 and the mold, so as to reduce the process difficulty and improve the product yield.
Further, the first coating portion 312 and the connecting layer 31 may be adhered and fixed, or may be integrally formed, etc., and may be selectively arranged by a user according to the need, which is not described herein.
In some preferred embodiments, as shown in fig. 8, the connection layer 31 includes a cladding frame 313, the cladding frame 313 has a plurality of through holes 3131, the first drug-carrying spike 32 is contained in the cladding frame 313, part of the first drug-carrying spike 32 is exposed from the through holes 3131, and the through holes 3131 are provided with a plurality of through holes and are sequentially arranged at intervals on the cladding frame 313, so that the exposed area of the first drug-carrying spike 32 can be increased, and the contact area of the first drug-carrying spike 32 with tissues is larger, so that the therapeutic effect is more remarkable.
Specifically, the cover frame 313 is preferably a pointed body, such as a cone or a polygonal cone, and the cover frame 313 and the connection layer 31 may be adhered and fixed or integrally formed, etc., and the user may select to set the cover frame according to the needs, which only needs to realize a stable connection between the cover frame 313 and the connection layer 31.
Further, the cover frame 313 is hollow, and the side surface of the cover frame 313 is provided with a through hole 3131 penetrating the inner and outer surfaces thereof, so that the inner and outer spaces of the cover frame 313 can be communicated. The first medicine carrying pointed body 32 is accommodated in the coating frame 313, and part of the first medicine carrying pointed body 32 is exposed from the through hole 3131, so that the medicine on the first medicine carrying pointed body 32 is contacted with the inner wall tissue of the human body lumen, air, water and the like, the surface of the first medicine carrying pointed body 32 is degraded, and the medicine inside is released into the body, so that the effects of medicine prevention and treatment and the like are exerted, meanwhile, the structure stability of the microneedle 3 can be further enhanced by the arrangement of the coating frame 313, the breakage of the first medicine carrying pointed body 32 is prevented, and the service life of the medicine carrying device is further prolonged.
In some preferred embodiments, as shown in fig. 9 and 10, the first drug-loaded spike 32 is a cone or a polygonal cone, the first drug-loaded spike 32 has a central axis y2, the central axis y2 is a line connecting the tip of the first drug-loaded spike 32 with the center point of the bottom surface thereof, and the central axis y2 of the first drug-loaded spike 32 is collinear with a radius of the supporting framework.
By the arrangement of the structure, the first medicine carrying pointed body 32 can be stably penetrated into tissues, the first medicine carrying pointed body 32 is prevented from being broken, and the treatment and stabilization effects are remarkable.
In some preferred embodiments, as shown in fig. 11 to 15, at least part of the outer wall and/or at least part of the inner wall of the support skeleton is provided with a cover film 4. When the covering film 4 covers at least part of the outer wall or at least part of the inner wall of the supporting framework, the first drug carrying spikes (not shown) may be located on opposite sides of the supporting framework with the covering film 4 or on the same side of the supporting framework as the covering film 4. When the cover film 4 covers at least part of the outer wall and at least part of the inner wall of the support skeleton, the first drug carrying spike passes through the cover film 4. The surface of the coating film 4 is provided with a plurality of second medicine carrying pointed bodies 5 which are mutually separated. In other embodiments, the surface of the cover film 4 is not provided with the second drug carrying spikes 5. The cover film 4 is made of biocompatible material such as ePTFE (garment fabric laminated with polytetrafluoroethylene microporous membrane and common fabric), PET (polyethylene terephthalate), silk fibroin, silicone, etc. The coating film 4 is fixed to the inner surface or the outer surface of the support frame or both the inner surface and the outer surface of the support frame, specifically, the coating film 4 is fixed to the inner surface of the wave ring 1 or the outer surface of the wave ring 1 or both the inner surface and the outer surface of the wave ring 1.
Further, when the second drug-carrying spike body 5 and the coating film 4 are made of the same material, such as silk fibroin, the second drug-carrying spike body 5 and the coating film 4 can be integrally formed, so that the connection of the second drug-carrying spike body 5 and the coating film 4 is firmer, the process steps and the difficulty are reduced, and the cost is reduced.
Further, the second drug-loaded spike 5 may be disposed on the outer surface of the film 4, may be disposed on the inner surface of the film 4, or may be disposed on both the inner surface and the outer surface of the film 4. The outer surface of the covering film 4 refers to the surface of the covering film 4 which is not contacted with the outer wall of the supporting framework, and the inner surface refers to the surface of the covering film 4 which is positioned in the inner cavity of the supporting framework and is not contacted with the inner wall of the supporting framework.
Furthermore, when the second medicine carrying spike 5 is disposed on the covering film 4, the height h1 of the second medicine carrying spike 5 is smaller than the thickness h2 of the supporting framework, so that the second medicine carrying spike 5 can be shielded and protected by the supporting framework, and damages such as breakage and the like to the second medicine carrying spike 5 when penetrating into tissues are prevented.
Further, the coating film 4 has a second coating portion 41, that is, the coating film 4 is provided with a plurality of second coating portions 41, a coating space is formed inside each second coating portion 41, the second coating portion 41 coats a portion of one second drug-carrying spike 5, that is, the proximal end 51 of the second drug-carrying spike 5 is accommodated in the coating space, and the area of the opening 411 of the coating space is smaller than the area of the proximal end 51 of the second drug-carrying spike 5, so that the proximal end 51 of the second drug-carrying spike 5 is movably accommodated in the coating space and cannot be removed from the opening 411, thereby realizing connection between the second drug-carrying spike 5 and the second coating portion 41, and the second drug-carrying spike 5 smoothly penetrates into tissues. The proximal end 51 is the end of the second drug-loaded spike 5 near the coating film 4.
Further, the solvent of the raw material liquid of the first drug-carrying spike body 32 and the second drug-carrying spike body 5 is water, and the solute is at least one of chitosan, sodium alginate, polyethylene glycol, PLGA (polylactic acid-hydroxy acid), PCL (polycaprolactone), PMMA (polymethyl methacrylate), PGA (polyglycolic acid), PLA (polylactic acid), PEA (polyetheramine), gelatin, hyaluronic acid, silk fibroin, and the like, and preferably a degradable material is used. Further dispersible liposomes in the first drug-loaded spike 32 and the second drug-loaded spike 5 are prepared from phosphatidylcholine and cholesterol. The raw material liquid and the liposome of the first drug-carrying spike body 32 and the second drug-carrying spike body 5 can carry different drugs, the added drugs are anti-hyperplasia drugs, therapeutic drugs, antibacterial drugs and the like, and common drugs are paclitaxel, rapamycin and derivatives thereof (such as sirolimus, zotarolimus, everolimus, tacrolimus and pimecrolimus), amine-coupled polyurethane (SA-PU) polymers and the like.
Further, the drugs may be added to the material liquid to form the first drug-carrying spike 32 or the second drug-carrying spike 5, and the drug content in the material liquid of the first drug-carrying spike 32 and the second drug-carrying spike 5 is 1% to 10%, and more preferably, the drug content in the material liquid of the first drug-carrying spike 32 and the second drug-carrying spike 5 is 1% to 5%. The surfaces of the first drug-carrying spike 32 and the second drug-carrying spike 5 may be coated, and the drug content is 1% to 20%, and more preferably, the drug content is 10% to 15%, and the above ranges are all mass percentages. Further, the total drug content of the implanted medical device is 30-300 ug. The limitation of the total amount and the percentage of the medicines can ensure the treatment effect of the medicines and reduce the generation of diseases such as intimal hyperplasia and the like.
Furthermore, in order to meet the clinical requirements of the target site, the first drug-carrying spike body 32 and the second drug-carrying spike body 5 can be designed to have proper height, diameter, quantity, drug-carrying concentration, drug-carrying type, degradation speed and the like, for example, the support framework is arranged at a place with overlarge pressure on the tissues, so that the proliferation is easier to be caused by stimulating the tissues, more first drug-carrying spike bodies 32 and second drug-carrying spike bodies 5 can be arranged at the place, for example, the support framework has shearing force action at the contact position with the tissues, so that proliferation is easier to be generated or granuloma is formed, and more first drug-carrying spike bodies 32 and second drug-carrying spike bodies 5 can be arranged to achieve a certain drug quantity to realize the effects of preventing proliferation and granuloma.
Furthermore, the same implanted medical device can be provided with a plurality of first medicine carrying spikes 32 and second medicine carrying spikes 5, and the first medicine carrying spikes 32 and the second medicine carrying spikes 5 can be different in height, diameter, quantity, medicine carrying concentration, degradation speed and the like, so that different requirements of different parts can be met, and the application range of the implanted medical device can be enlarged.
Further, the supporting framework and the covering film 4 can be provided with a plurality of first medicine carrying spikes 32 and second medicine carrying spikes 5, and the first medicine carrying spikes 32 and the second medicine carrying spikes 5 can carry different medicines, so that treatment of different diseases can be realized, and a user can set the medicine carrying spikes according to needs and are not repeated here.
Further, as shown in fig. 16, when the implanted medical device is used for the stenosis of a trachea or a bronchus, firstly, the supporting framework is pressed and held on the surface of the balloon 7, and then the supporting framework and the balloon are put into the sheath tube 6 together, so that in order to ensure that the first medicine carrying spike body 32 and the second medicine carrying spike body 5 are not damaged when being put into the sheath tube 6, the distance between the tips of the first medicine carrying spike body 32 and the second medicine carrying spike body 5 and the inner wall of the sheath tube 6 is L, wherein L is more than or equal to 0.1mm and less than or equal to 0.5mm, and therefore, the situation that the first medicine carrying spike body 32 and the second medicine carrying spike body 5 touch the sheath tube 6 during assembly or the contour of the sheath tube 6 is too large can be avoided, so that some patients cannot be applied. Then, under the guidance of a guide wire, the part of the sheath tube 6 loaded with the implanted medical instrument is conveyed to a target position, liquid is injected into the balloon 7, and the pressure is increased to 16 to 26 atmospheres, so that the supporting framework begins to expand under the pushing action of the balloon 7, then the first medicine carrying pointed body 32 and the second medicine carrying pointed body 5 penetrate into tissues, at the moment, the whole first medicine carrying pointed body 32 and the second medicine carrying pointed body 5 can be selected to penetrate into the tissues according to the needs, or the parts of the first medicine carrying pointed body 32 and the second medicine carrying pointed body 5 penetrate into the tissues, if the supporting framework is made of degradable materials, and the degradation speed is higher than that of the first medicine carrying pointed body 32 and the second medicine carrying pointed body 5, the tissues are not pressed after degradation, and the risk of subsequent tissue hyperplasia is reduced. Compared with the existing medical instrument with medicine implantation, the first medicine carrying pointed body 32 and the second medicine carrying pointed body 5 can penetrate into tissues, medicine is slowly released along with degradation of the first medicine carrying pointed body 32 and the second medicine carrying pointed body 5, the acting time of the medicine is prolonged, the first medicine carrying pointed body 32 and the second medicine carrying pointed body 5 can carry various medicines with different concentrations so as to realize different effects, the first medicine carrying pointed body 32 is firmly connected with the supporting framework, the second medicine carrying pointed body 5 is firmly connected with the covering film 4, separation of the two is effectively prevented, and stability and safety are good.
Finally, it should be noted that the above embodiments are only for illustrating the technical solution of the present utility model, and the application scenario of the implanted medical device is not limited to the field described herein, and although the present utility model has been described in detail with reference to the foregoing embodiments, it should be understood by those skilled in the art that the technical solution described in the foregoing embodiments may be modified or some of the technical features may be equivalently replaced, and these modifications or substitutions do not make the essence of the corresponding technical solution deviate from the spirit and scope of the technical solution of the embodiments of the present utility model.