Magnesium alloy balloon expanding esophageal stent based on microsphere drug loading technology

Abstract

The invention relates to the technical field of medical instruments, in particular to a magnesium alloy balloon dilatation type esophageal stent based on a microsphere drug loading technology. The support assembly comprises a plurality of annular supports, a plurality of wire penetrating holes are formed in the annular supports, the wire penetrating holes completely penetrate through the annular supports, and the wire penetrating holes are distributed in an annular array mode with the circle center of the ring defined by the annular supports as the circle center. The medicine injection assembly comprises a connecting wire and a convex handle, and the side, away from the connecting wire, of the convex handle is fixedly connected with a microsphere. According to the magnesium alloy balloon expanding esophageal stent based on the microsphere drug loading technology, the annular stent, the lifting stent, the connecting wire, the lantern ring, the convex handle and the microspheres are made of magnesium alloy (Mg-Zn-Mn-C / Zr), the content of Mg in the magnesium alloy accounts for 95% or above, the magnesium alloy can be naturally absorbed and degraded by a human body, and the magnesium alloy can be uniformly degraded within about one to three months without being taken out, so that secondary injury to a patient is avoided; meanwhile, trace hydrogen generated in the magnesium alloy degradation process has a cell repairing effect.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a magnesium alloy balloon expandable esophageal stent based on microsphere drug-loading technology. Background Art

[0002] Currently, esophageal cancer is generally treated with an esophageal stent, which is usually made of nickel-titanium shape memory alloy. The implantation of the esophageal stent is usually to relieve symptoms such as esophageal stenosis or esophageal fistula, and to help patients restore normal eating and digestive functions.

[0003] The existing method of preventing esophageal stents from displacing is generally to fix the esophageal stent to the inner wall of the esophagus through metal barbs, but this method will cause damage to the inner wall tissue of the esophagus. At the same time, most esophageal stents are self-expanding, which will result in a low fit between the stent and the esophageal wall. In addition, the material of the esophageal stent is mostly nickel-titanium alloy, which is a non-degradable material. It is difficult to remove it later and will also have secondary effects on the esophageal tissue. Summary of the invention

[0004] The purpose of the present invention is to provide a magnesium alloy balloon expandable esophageal stent based on microsphere drug-loaded technology, so as to solve the problem that it is inconvenient to collect and decompose solid garbage and waste in daily family life, which leads to harm to the environment and inconvenience in manual classification. To achieve the above purpose, the present invention provides the following technical solution: a magnesium alloy balloon expandable esophageal stent based on microsphere drug-loaded technology, comprising a balloon;

[0005] A bracket assembly, wherein the bracket assembly includes a plurality of annular brackets, and a plurality of threading holes are opened inside the annular brackets, and the threading holes completely penetrate the annular brackets, and each of the threading holes is distributed in an annular array with the center of the ring formed by the annular brackets as the center;

[0006] The medicine injection component comprises a connecting wire and a protruding handle, and a micro-ball is fixedly connected to the side of the protruding handle away from the connecting wire.

[0007] Further preferably, a pulling bracket is fixedly connected between each adjacent annular bracket, the connecting wire completely passes through each annular bracket through the wire threading hole on the annular bracket, the head and tail ends of the connecting wire are respectively fixedly connected to two annular brackets and the connecting wire is movably connected to the remaining annular brackets.

[0008] Further preferably, a plurality of rings are fixedly sleeved on the side surface of the connecting wire and the side surface of the ring is fixedly connected to the protruding handle, a hollow cavity for storing drugs is opened inside the microsphere, a plurality of nanoscale micropores are opened on the surface of the microsphere and the nanoscale micropores are connected to the hollow cavity inside the microsphere, and the esophageal stent is installed in a balloon type, which has high efficiency, high fit and more precise installation position during endoscopic examination. At the same time, magnesium alloy material (Mg-Zn-Mn-C / Zr) that does not contain rare earth and aluminum elements is used, which is safe and reliable, and the support and stress distribution fully meet clinical requirements. The hydrogen generated during the degradation of the magnesium alloy is helpful for sterilization and disinfection and cell tissue repair. Magnesium naturally exists in the human body and has good cell compatibility.

[0009] Further preferably, a guide tube is fixedly sleeved inside the balloon, the guide tube is a hollow tube, a side surface of the guide tube is provided with an inflation port for inflating the balloon, and the inflation port is communicated with the inside of the guide tube.

[0010] Further preferably, a film assembly is provided on the outside of the bracket assembly, and the film assembly includes a medical coating, the medical coating is coated on the side surfaces of the annular bracket and the lifting bracket, and the medical coating is fixedly connected to the annular bracket at both ends of the connecting wire, and a plurality of perforations are opened inside the medical coating and the protruding handle passes through the perforations.

[0011] Compared with the prior art, the present invention has the following beneficial effects:

[0012] In the present invention, the annular stent, the lifting stent, the connecting wire, the collar, the protruding handle and the microsphere are made of a magnesium alloy (Mg-Zn-Mn-C / Zr), the magnesium content of which is more than 95%, and can be naturally absorbed and degraded by the human body. It degrades evenly in about one to three months without removal to avoid secondary damage to the patient. Meanwhile, a trace amount of hydrogen is generated during the degradation process of the magnesium alloy, which has a cell repair effect.

[0013] In the present invention, the medical coating is also a degradable material, which can gradually degrade over time and reduce the process of removing the stent later. It replaces the traditional esophageal stent made of nickel-titanium memory alloy and is fixed by barbs. Multiple microspheres are used to increase the friction with the inner wall of the esophagus, ensuring that no displacement will occur in the early stage of treatment and reducing damage to the inner wall of the esophagus. The esophageal stent is installed by balloon expansion. Compared with most current self-expanding stents, the installation quality is better and the surgical error rate is lower. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] Figure 1 It is a schematic diagram of the three-dimensional structure of the present invention;

[0015] Figure 2 This is a schematic diagram of the medical coating structure of the present invention;

[0016] Figure 3 This is a schematic diagram of the structure of the drug injection assembly of the present invention;

[0017] Figure 4 It is a schematic diagram of the structure of the bracket assembly of the present invention;

[0018] Figure 5 It is a schematic diagram of the structure of the balloon and the guide tube of the present invention;

[0019] Figure 6 This is a partially enlarged structural schematic diagram of the drug injection component of the present invention;

[0020] Figure 7 It is a schematic diagram of the cross-sectional structure of the present invention.

[0021] In the figure: 1, balloon; 2, stent assembly; 3, injection assembly; 4, film assembly; 5, guide tube; 6, inflation port; 201, annular stent; 202, lifting stent; 203, threading hole; 301, connecting wire; 302, collar; 303, boss; 304, microsphere; 401, medical coating; 402, perforation. DETAILED DESCRIPTION

[0022] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technical personnel in this field without creative work are within the scope of protection of the present invention.

[0023] See also Figure 1-Figure 7 The present invention provides a technical solution: a magnesium alloy balloon-expandable esophageal stent based on microsphere drug-loading technology, comprising a balloon 1; a stent assembly 2, the stent assembly 2 comprising a plurality of annular stents 201 and a plurality of threading holes 203 are opened inside the annular stents 201 and the threading holes 203 completely penetrate the annular stents 201, and each threading hole 203 is distributed in an annular array with the center of the ring surrounded by the annular stents 201 as the center; a drug injection assembly 3, the drug injection assembly 3 comprising a connecting wire 301 and a protruding handle 303, and a microsphere 304 is fixedly connected to the side of the protruding handle 303 away from the connecting wire 301.

[0024] In this embodiment, Figure 4 and Figure 7As shown, a lifting bracket 202 is fixedly connected between each adjacent annular bracket 201, and a connecting wire 301 completely penetrates each annular bracket 201 through a wire threading hole 203 on the annular bracket 201. The head and tail ends of the connecting wire 301 are respectively fixedly connected to two annular brackets 201 and the connecting wire 301 is movably connected to the remaining annular brackets 201. The esophageal bracket is installed in a balloon-type manner and is installed during endoscopic examination. It has high efficiency, high fit, and more precise installation position. At the same time, a magnesium alloy material (Mg-Zn-Mn-C / Zr) that does not contain rare earth and aluminum elements is used, which is safe and reliable, and the support and stress distribution fully meet clinical requirements. The hydrogen generated during the degradation of the magnesium alloy is helpful for sterilization and disinfection and cell tissue repair. Magnesium naturally exists in the human body and has good cell compatibility.

[0025] In this embodiment, Figure 3 , Figure 6 and Figure 7 As shown, the side surface of the connecting wire 301 is fixedly sleeved with a plurality of rings 302 and the side surface of the rings 302 is fixedly connected to the protruding handle 303, the inside of the microsphere 304 is provided with a hollow cavity for storing drugs, the surface of the microsphere 304 is provided with a plurality of nano-scale micropores and the nano-scale micropores are connected to the hollow cavity inside the microsphere 304.

[0026] In this embodiment, Figure 1 , Figure 5 and Figure 7As shown, the inside of the balloon 1 is fixedly sleeved with a guide tube 5, which is a hollow tube. The side surface of the guide tube 5 is provided with an inflation port 6 for inflating the balloon 1, and the inflation port 6 is communicated with the inside of the guide tube 5. When in use, the device is delivered to the patient's part of the esophagus through the guide tube 5, and gas is introduced into the inside of the guide tube 5 so that the gas inflates the balloon 1 from the inflation port 6 on the guide tube 5. When the balloon 1 is inflated, the contracted annular stent 201 is expanded, so that the annular stent 201 and the lifting stent 202 are unfolded. The ring 302, the protruding handle 303 and the microsphere 304 are connected in series through the connecting wire 301, so that when the annular stent 201 is expanded, the microsphere 304 first contacts the inner wall of the esophagus, and then the medical coating 401 contacts the inner wall of the esophagus and is unfolded. The annular stent 201 expands the narrow part of the esophagus, and then extracts the gas in the balloon 1 through the guide tube 5, so that the guide tube 5 and the balloon 1 are extracted from the annular stent 201 and the lifting stent 202. The microspheres 304 have been injected with therapeutic drugs in their inner cavity before the operation, and after being implanted in the esophagus, the microspheres 304 are in direct contact with the inner wall of the esophagus, so that the microspheres 304 slowly release the drugs to the lesion site through the nano-scale micropores coated on the surface and the gradual decomposition for continuous treatment. The annular stent 201, the lifting stent 202, the connecting wire 301, the ring 302, the protruding handle 303 and the microspheres 304 are made of magnesium alloy metal with a magnesium content of more than 95%, which is easy to be decomposed and metabolized, and does not need a second operation to remove them after the patient recovers.

[0027] In this embodiment, Figure 1 , Figure 2 and Figure 7 As shown, a film component 4 is arranged on the outside of the bracket component 2, and the film component 4 includes a medical coating 401. The medical coating 401 is coated on the side surfaces of the annular bracket 201 and the lifting bracket 202, and the medical coating 401 is fixedly connected to the annular bracket 201 at both ends of the connecting wire 301. A plurality of through holes 402 are opened inside the medical coating 401, and the protruding handle 303 passes through the through holes 402.

[0028] The use method and advantages of the present invention: The magnesium alloy balloon expandable esophageal stent based on microsphere drug-loaded technology, when in use, has the following working process:

[0029] like Figure 1 , Figure 2 , Figure 3 , Figure 4 , Figure 5 , Figure 6 and Figure 7As shown, when in use, the device is delivered to the affected part of the esophagus through the guide tube 5, and gas is introduced into the guide tube 5 so that the gas inflates the balloon 1 from the inflation port 6 on the guide tube 5. When the balloon 1 is inflated, the contracted annular stent 201 is expanded, so that the annular stent 201 and the lifting stent 202 are unfolded. The ring 302, the protruding handle 303 and the microsphere 304 are connected in series through the connecting wire 301, so that when the annular stent 201 is expanded, the microsphere 304 first contacts the inner wall of the esophagus, and then the medical coating 401 contacts the inner wall of the esophagus and expands the narrow part of the esophagus through the expanded annular stent 201, and then the gas in the balloon 1 is passed through the guide tube 5. The guide tube 5 is pulled out, so that the guide tube 5 and the balloon 1 are pulled out from the inside of the annular stent 201 and the lifting stent 202, and the microspheres 304 have been injected with therapeutic drugs in their inner cavities before the operation, and after being implanted in the esophagus, the microspheres 304 are in direct contact with the inner wall of the esophagus, so that the microspheres 304 slowly release the drugs to the lesion site through the nano-scale micropores coated on the surface and the gradual decomposition for continuous treatment. The annular stent 201, the lifting stent 202, the connecting wire 301, the ring 302, the protruding handle 303 and the microspheres 304 are made of magnesium alloy metal with a magnesium content of more than 95%, which is easy to be decomposed and metabolized, and no secondary operation is required to remove them after the patient recovers.

[0030] The above shows and describes the basic principles, main features and advantages of the present invention. Technical personnel in this industry should understand that the present invention is not limited to the above embodiments. The above embodiments and descriptions are only preferred examples of the present invention and are not used to limit the present invention. Without departing from the spirit and scope of the present invention, the present invention may have various changes and improvements, which fall within the scope of the present invention to be protected. The scope of protection of the present invention is defined by the attached claims and their equivalents.

Claims

1. A magnesium alloy balloon-expandable esophageal stent based on microsphere drug-loaded technology, characterized in that: comprising a balloon (1); A support assembly (2), the support assembly (2) comprising a plurality of annular supports (201), the annular supports (201) being provided with a plurality of threading holes (203) inside, the threading holes (203) completely passing through the annular supports (201), each of the threading holes (203) being distributed in an annular array with the center of the annular circle surrounded by the annular supports (201); The drug injection component (3) comprises a connecting wire (301) and a protruding handle (303), wherein a micro-ball (304) is fixedly connected to a side of the protruding handle (303) away from the connecting wire (301).

2. The magnesium alloy balloon-expandable esophageal stent based on microsphere drug-loaded technology according to claim 1, characterized in that: A lifting bracket (202) is fixedly connected between each adjacent annular bracket (201), and the connecting wire (301) completely penetrates each annular bracket (201) through the wire threading hole (203) on the annular bracket (201). The head and tail ends of the connecting wire (301) are respectively fixedly connected to the two annular brackets (201), and the connecting wire (301) is movably connected to the remaining annular brackets (201).

3. The magnesium alloy balloon-expandable esophageal stent based on microsphere drug-loaded technology according to claim 1, characterized in that: The side surface of the connecting wire (301) is fixedly sleeved with a plurality of rings (302), and the side surface of the rings (302) is fixedly connected to the protruding handle (303). The inside of the microsphere (304) is provided with a hollow cavity for storing drugs. The surface of the microsphere (304) is provided with a plurality of nano-scale micropores, and the nano-scale micropores are connected to the hollow cavity inside the microsphere (304).

4. The magnesium alloy balloon-expandable esophageal stent based on microsphere drug-loaded technology according to claim 1, characterized in that: A guide tube (5) is fixedly sleeved inside the balloon (1); the guide tube (5) is a hollow tube; a blowing port (6) for inflating the balloon (1) is provided on the side surface of the guide tube (5); and the blowing port (6) is communicated with the inside of the guide tube (5).

5. The magnesium alloy balloon-expandable esophageal stent based on microsphere drug-loaded technology according to claim 1, characterized in that: A film component (4) is arranged on the outside of the support component (2), and the film component (4) includes a medical coating (401). The medical coating (401) covers the side surfaces of the annular support (201) and the lifting support (202), and the medical coating (401) is fixedly connected to the annular support (201) at both ends of the connecting wire (301). A plurality of through holes (402) are opened inside the medical coating (401), and the protruding handle (303) passes through the through holes (402).

Images