Tracheal stent which can be absorbed and has a drug coating
By designing an absorbable polylactic acid (PLA) tracheal stent and utilizing an externally expanding drug-coated groove and a drug-coated strip, the problems of stent slippage and granulation tissue growth were solved, achieving stable stent expansion in vivo and continuous drug action, thus enhancing the stability and safety of the stent.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- THE AFFILIATED HOSPITAL OF QINGDAO UNIV
- Filing Date
- 2025-04-29
- Publication Date
- 2026-07-21
AI Technical Summary
Existing tracheal stents are prone to slippage after degradation in the body, which may cause discomfort to patients. Furthermore, the hollow structure can easily induce granulation tissue growth, leading to tracheal restenosis.
An absorbable tracheal stent with a drug coating was designed. It uses a polylactic acid shell and a membrane structure. Through the design of an external drug groove and a drug coating strip, the stent can expand on its own in the body and slowly release the expansion force, avoiding granulation tissue growth and enhancing the stability of the stent.
The stent expands on its own within the body, and the drug coating continues to work, preventing restenosis caused by stent slippage and granulation tissue growth, thus improving the stability and safety of the stent.
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Figure CN224523350U_ABST
Abstract
Description
TECHNICAL FIELD
[0001] The utility model relates to medical instrument technical field, concretely is tracheal stent that can be absorbed and contains drug coating. BACKGROUND
[0002] Tracheal stent is a solution tracheal cavity obstruction or stenosis prosthesis, is a kind of tracheal lumen forming operation equipment, it provides internal support by resisting the pressure of tracheal wall, to keep the diameter and patency of lumen structure.Usually be used for treating inflammatory granuloma, scar, tuberculosis, trauma, tracheomalacia, amyloidosis and tumor etc. Lesion caused trachea and bronchus stenosis;Airway stenosis can cause obstructive pneumonia, atelectasis and dyspnea, patients appear dyspnea, wheezing, choking cough and other symptoms serious can occur respiratory failure and endanger life. Tracheal stent placement is one of important means of treating airway stenosis, can quickly relieve dyspnea, improve clinical symptoms.
[0003] The utility model discloses a kind of tracheal stents for infants, the tracheal stent is in the form of circular cylinder with notch, the cross section of cylinder is in the form of "C", the central angle of "C" type notch is 75 °-115 °.The inner diameter of the tracheal stent is 6mm-7mm, wall thickness is 0.4mm-0.6mm, length is 20mm-100mm.Each 5mm apart in the longitudinal direction of the inner side of tracheal stent, a 1mm wide, 0.1mm deep groove is arranged in the tracheal stent.Each two grooves in the cylinder wall of the tracheal stent are transversely evenly distributed at least 4 square holes with 2mm length and 1mm width.3D printing is obtained by the tracheal stent with polypropylene acid ester / polymethyl propylene acid ester photosensitive resin PIC100.
[0004] Its C type structure can indeed more adapt to the tracheal lesion site of sick child, with stress in cross section direction, so as not to slip off easily, and the gap can also play a certain self-adapting role. But because resin material still needs to be taken out of body after complete recovery. Then, its stress changes with the compression force of tracheal wall when in body, and patients can feel uncomfortable;And the stent with hollow is placed in trachea, and new granulation can grow along the edge of hollow or hard object, so that new granulation can easily cause restenosis of trachea. Utility model content
[0005] In order to overcome the defects in the prior art, the purpose of the utility model is to provide tracheal stent that can be absorbed and contains drug coating, to solve the problems raised in the above background art.
[0006] In order to achieve the above object, the utility model provides can be absorbed and contain medicine coating's tracheal stent, including the casing of cylindrical shape, the casing includes four longitudinal skeletons, the circle skeleton of a plurality of intervals is arranged between longitudinal skeleton, the casing outer wall is set a plurality of for depositing medicine's outer medicine groove, the assembly groove of circle skeleton inside and between two adjacent outer medicine grooves setting is located and the skirt groove of casing inside and between two adjacent circle skeleton setting is located, The outer part of the shell is pasted with a film by glue, the film includes a shrink film pasted and wrapped around the outer part of the shell, the shrink film includes a contact film for pasting on the corresponding outer part of the shell of the assembly groove and a closing film for closing the side notch of the outer medicine groove, and the outer medicine groove is filled with a medicine coating strip; when the closing film degrades, the outer medicine groove expands and drives the medicine coating strip to expand outward synchronously.
[0007] As a further improvement of the technical solution, the outer medicine groove and the assembly groove are both centrally symmetrically arranged, the materials of the shell and the film are both biodegradable and elastic polylactic acid materials, the glue on the inner wall of the film for pasting with the outer wall of the shell is polylactic acid glue, and the thickness of the glue is less than the thickness of the shrink film.
[0008] As a further improvement of the technical solution, all the longitudinal skeletons, all the outer medicine grooves and all the assembly grooves are parallel to each other, the assembly groove is in a circular arc shape, the outer medicine groove is also in a circular arc shape and a plurality of ball convex villi are fixedly arranged on the groove wall of the outer medicine groove, and all the ball convex villi are arranged in a matrix shape at equal intervals.
[0009] As a further improvement of the technical solution, at least four circle skeletons are arranged, and the inner height of the circle skeleton far from the middle part of the shell is less than the inner height of the circle skeleton close to the middle part of the shell.
[0010] As a further improvement of the technical solution, the groove depth of the outer medicine groove is at least one tenth of the outer diameter of the shell; the thicknesses of the longitudinal skeleton and the circle skeleton are equal, and the thicknesses of the two are at most one third of the groove depth of the outer medicine groove; and the thickness of the shrink film is at most one third of the thickness of the circle skeleton.
[0011] As a further improvement of the technical solution, the groove depth of the assembly groove is equal to the groove depth of the outer medicine groove, and the length of the contact film is less than or equal to the arc length of the corresponding outer part of the shell of the assembly groove.
[0012] As a further improvement of the technical solution, the length of the closing film is greater than or equal to the notch width of the outer medicine groove.
[0013] As a further improvement to this technical solution, a degradation groove is vertically formed on the inner sidewall of each of the sealed membranes, and the degradation groove is located in the center of the sealed membrane.
[0014] As a further improvement to this technical solution, the width of the shrink film is equal to the length of the shell, the length of the shrink film is greater than or equal to the outer perimeter of the shell, and a circular cover film is integrally formed at the upper and lower edges of the sealing film, the thickness of the cover film is less than the thickness of the sealing film.
[0015] As a further improvement to this technical solution, a plurality of cover film flaps for fixing the cover film are integrally formed at the arc edge of the cover film. The shape of the cover film is similar to the cross-sectional shape of the outward-expanding medicine trough, and the size of the cover film is greater than or equal to the cross-sectional size of the outward-expanding medicine trough.
[0016] Compared with the prior art, the beneficial effects of this utility model are as follows: 1. This absorbable, drug-coated tracheal stent, through its ring-shaped framework, outward-expanding drug reservoir, contact membrane, sealing membrane, and drug coating, allows the sealing membrane to degrade first after the stent is placed in the trachea. This releases the stress in the ring-shaped framework corresponding to each outward-expanding drug reservoir, thereby expanding the outer diameter of the entire tracheal stent. Simultaneously, the drug coating strip expands outward to press against the lesion, enabling the stent to self-degrade within the patient's body. During the degradation process, the stent's expansion force is slowly released, thus offsetting the reduction in stent expansion force caused by thinning of the stent wall after degradation or natural tracheal growth. This dynamically maintains the stent's expansion force and increases its stability.
[0017] 2. This absorbable, drug-coated tracheal stent utilizes spherical protuberances within the external drug-coating groove to ensure better adhesion of the drug-coated strip after filling. As the drug-coated strip expands outwards and presses against the affected area, it ensures the drug remains effective at the site for a longer period. The stent's exterior is not perforated, thus preventing tracheal restenosis caused by granulation tissue and scarring. Because the stent is made entirely of biodegradable materials, the longitudinal and circular skeletons are thicker than the corresponding shell portions of the skirt grooves, maintaining the overall strength of the stent while saving material. Furthermore, the inner height of the circular skeletons further from the center of the shell is smaller than that of the circular skeletons closer to the center, causing the skeleton to degrade from both ends towards the middle, reducing the probability of the stent breaking before the middle, thereby increasing the stent's stability and safety. Attached Figure Description
[0018] The accompanying drawings described herein are for illustrative purposes only and are not intended to limit the scope of this invention in any way. Furthermore, the shapes and proportions of the components in the drawings are merely illustrative to aid in understanding the invention and do not specifically limit the shapes and proportions of the components. Those skilled in the art, under the guidance of this invention, can select various possible shapes and proportions to implement this invention according to specific circumstances.
[0019] Figure 1 This is a schematic diagram of the overall structure of this utility model; Figure 2 This is a schematic diagram of the shell in its expanded state in this utility model; Figure 3 This utility model Figure 1 One of the magnified views of a section at point A in the middle; Figure 4 This utility model Figure 1 Part 2 of the enlarged view of point A in the middle; Figure 5 This utility model Figure 2 A magnified view of a section at point B in the middle; Figure 6 This is a schematic diagram of the structure of the spherical convex hairs in this utility model; Figure 7 This is a schematic diagram of the top surface structure of this utility model; Figure 8 This is a schematic diagram of the cross-sectional structure of this utility model; Figure 9 This is a schematic diagram of the cross-sectional structure of the shell in this utility model; Figure 10 This utility model Figure 8 A magnified view of a section at point C; Figure 11 This is a partial structural diagram of the coating in this utility model; Figure 12 This utility model Figure 11 A magnified view of a section at point D; The meanings of the labels in the diagram are as follows: 1. Shell; 10. Longitudinal skeleton; 11. Circular skeleton; 110. Outer medicine reservoir; 111. Assembly groove; 12. Skirt groove; 13. Ball-shaped pile; 2. Lamination; 20. Shrink film; 201. Contact film; 202. Sealing film; 2021. Degradation tank; 21. Cover film; 22. Cover flap; 3. Drug-coated strips. Detailed Implementation
[0020] The details of this utility model can be more clearly understood by referring to the accompanying drawings and the description of specific embodiments. However, the specific embodiments of this utility model described herein are for illustrative purposes only and should not be construed as limiting the utility model in any way. Under the teachings of this utility model, those skilled in the art can conceive of any possible modifications based on this utility model, and these should all be considered to fall within the scope of this utility model. The terms "installation" and "connection" should be interpreted broadly, referring to direct connection or indirect connection through an intermediate medium.
[0021] The terms "central axis," "vertical," "horizontal," "front," "rear," "upper," "lower," "left," "right," "top," "bottom," "inner," and "outer" used herein to indicate orientation or positional relationships are based on the orientation or positional relationships shown in the accompanying drawings. They are used solely for the convenience of describing this utility model and for simplifying the description, and do not indicate or imply that the device or component referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this utility model. Furthermore, in the description of this utility model, "a number" means two or more, unless otherwise explicitly specified.
[0022] Please see Figures 1-12 As shown, this utility model provides an absorbable tracheal stent with a drug coating, including a cylindrical shell 1. The shell 1 includes four longitudinal skeletons 10, a plurality of ring skeletons 11 equally spaced between the longitudinal skeletons 10, a plurality of outward drug slots 110 for storing drugs opened on the outer wall of the shell 1, an assembly slot 111 disposed on the inner side of the ring skeletons 11 and between two adjacent outward drug slots 110, and a skirt groove 12 disposed on the inner side of the shell 1 and between two adjacent ring skeletons 11. The skirt groove 12 can reduce the material used in the tracheal stent, thereby reducing the manufacturing cost. The outer surface of the housing 1 is covered with a film 2 by adhesive. The film 2 includes a shrink film 20 that is pasted and wrapped around the outer surface of the housing 1. The shrink film 20 includes a contact film 201 for pasting onto the outer surface of the housing 1 corresponding to the assembly groove 111 and a sealing film 202 for sealing the side opening of the outward-expanding drug groove 110. The outward-expanding drug groove 110 is filled with a drug coating strip 3. When the sealing film 202 degrades, the outward-expanding drug groove 110 expands outward and drives the drug coating strip 3 to expand outward synchronously. Thus, the drug coating strip 3 can also resist the tracheal wall so that the drug can continuously and fully act on the inner wall of the trachea.
[0023] The external medicine slot 110 and the assembly slot 111 are both centrally symmetrically arranged. The shell 1 and the membrane 2 are both made of biodegradable and elastic polylactic acid, which ensures that the outer diameter of the stent can be reduced to be easily moved from the throat to the tracheal stenosis before it is placed to the target position. The adhesive used to attach the membrane 2 to the outer wall of the shell 1 is polylactic acid adhesive, and the thickness of the adhesive is less than the thickness of the shrink membrane 20, which ensures that the adhesive can be degraded before the shell 1.
[0024] Preferably, all longitudinal skeletons 10, all outward-expanding drug troughs 110, and all assembly troughs 111 are parallel to each other. The inside of the assembly trough 111 is arc-shaped, and the inside of the outward-expanding drug trough 110 is arc-shaped with a number of spherical protrusions 13 fixed on its trough wall. All the spherical protrusions 13 are arranged in a matrix with equal spacing, so that the drug coating strip can better adhere to the outward-expanding drug trough after filling. When the drug coating strip expands outward and presses against the lesion, it can ensure that the drug acts on the lesion for a longer time.
[0025] Specifically, at least four circular skeletons 11 are provided, and the inner height of the circular skeletons 11 far from the middle of the shell 1 is smaller than the inner height of the circular skeletons 11 near the middle of the shell 1. This makes the longitudinal skeleton 10 and the circular skeletons 11 degrade from both ends to the middle when they degrade, reducing the probability that the degraded stent breaks before the middle, thereby increasing the stability and safety of the stent.
[0026] Specifically, the depth of the outward-expanding drug reservoir 110 is at least one-tenth of the outer diameter of the shell 1; the longitudinal skeleton 10 and the circular skeleton 11 are of equal thickness, and their thickness is at most one-third of the depth of the outward-expanding drug reservoir 110 to ensure that the support has sufficient ventilation inner diameter; the thickness of the shrinkage membrane 20 is at most one-third of the thickness of the circular skeleton 11 to ensure that the shrinkage membrane 20 is degraded before the shell 1.
[0027] Specifically, the depth of the assembly groove 111 is equal to the depth of the outer expansion groove 110, and the length of the contact film 201 is less than or equal to the outer arc length of the housing 1 corresponding to the assembly groove 111, thereby ensuring that the contact film 201 can be completely adhered to the outside of the housing 1 part corresponding to the assembly groove 111.
[0028] Specifically, the length of the sealing membrane 202 is greater than or equal to the width of the slot of the outward expansion medicine tank 110, thereby ensuring that the tightening membrane 20 applies tension to the two side shells 1 corresponding to the slot of the outward expansion medicine tank 110 to lock the expansion force at the slot of the outward expansion medicine tank 110.
[0029] Preferably, each sealed membrane 202 has a vertically formed degradation groove 2021 on its inner sidewall, and the degradation groove 2021 is located in the center of the sealed membrane 202, so that the sealed membrane 202 can degrade faster at the rapid degradation groove 2021, thereby releasing the expansion force at the opening of the outward expansion medicine groove 110.
[0030] Preferably, the width of the shrinking film 20 is equal to the length of the shell 1, and the length of the shrinking film 20 is greater than or equal to the outer perimeter of the shell 1, so as to better seal and tighten the outside of the shell 1. The upper and lower edges of the sealing film 202 are integrally formed with a circular cover film 21. The thickness of the cover film 21 is less than the thickness of the sealing film 202, so that it can be degraded first so as not to affect the degradation of the sealing film 202, release the expansion force at the opening of the outward expansion drug tank 110 and the drug coating strip 3.
[0031] Preferably, a plurality of cover film flaps 22 for fixing the cover film 21 are integrally formed at the arc edge of the cover film 21. The shape of the cover film 21 is similar to the cross-sectional shape of the outward-expanding drug reservoir 110, and the size of the cover film 21 is greater than or equal to the cross-sectional size of the outward-expanding drug reservoir 110. The inner side of the cover film flaps 22 is also coated with biodegradable adhesive. The cover film flaps 22 can be folded inward and pasted on the edge of the corresponding end ring frame 11, thereby better fixing the cover film 21 and sealing the upper and lower ends of the drug coating strip 3.
[0032] The working principle of this utility model: After the tracheal stent is placed in the patient's tracheal lesion for a period of time, the shrinkage membrane 20 degrades and cracks from several degradation grooves 2021. The outward stress of the outward expansion drug groove 110 at the corresponding position of the ring skeleton 11 is released, which increases the expansion force of the stent and offsets the insufficient expansion force of the stent caused by the thinning of the stent wall after degradation or the natural growth of the trachea. At the same time, the drug coating strip 3 in the outward expansion drug groove 110 also presses outward against the narrow part of the inner wall of the trachea, so that the drug can fully act on that part.
[0033] Finally, it should be noted that the above embodiments are only for illustrating the technical concept and features of this utility model, and are intended to enable those skilled in the art to understand the content of this utility model and implement it accordingly. They should not be used to limit the protection scope of this utility model. All equivalent changes or modifications made in accordance with the spirit and essence of this utility model should be included within the protection scope of this utility model.
Claims
1. An absorbable tracheal stent with a drug-coated structure, characterized in that: The shell (1) is cylindrical in shape. The shell (1) includes four longitudinal skeletons (10), a number of ring skeletons (11) evenly spaced between the longitudinal skeletons (10), a number of outward medicine slots (110) for storing medicines opened on the outer wall of the shell (1), an assembly slot (111) provided on the inner side of the ring skeletons (11) and located between two adjacent outward medicine slots (110), and a skirt slot (12) provided on the inner side of the shell (1) and located between two adjacent ring skeletons (11). The outer side of the housing (1) is covered with a film (2) by adhesive. The film (2) includes a shrink film (20) that is pasted and wrapped around the outer side of the housing (1). The shrink film (20) includes a contact film (201) for pasting onto the outer side of the housing (1) corresponding to the assembly groove (111) and a sealing film (202) for sealing the side opening of the outward expansion drug groove (110). The outward expansion drug groove (110) is filled with a drug coating strip (3). When the sealing film (202) degrades, the outward expansion drug groove (110) expands outward and drives the drug coating strip (3) to expand outward synchronously.
2. The absorbable tracheal stent with a drug coating according to claim 1, characterized in that: The outer expansion tank (110) and the assembly tank (111) are both centrally symmetrically arranged. The shell (1) and the membrane (2) are both made of biodegradable and elastic polylactic acid. The adhesive used to attach the inner wall of the membrane (2) to the outer wall of the shell (1) is polylactic acid adhesive, and the thickness of the adhesive is less than the thickness of the shrink film (20).
3. The absorbable tracheal stent with a drug-coated structure according to claim 1, characterized in that: All longitudinal skeletons (10), all the outer medicine troughs (110) and all the assembly troughs (111) are parallel to each other. The inside of the assembly trough (111) is arc-shaped. The inside of the outer medicine trough (110) is arc-shaped and a number of spherical protrusions (13) are fixed on its trough wall. All the spherical protrusions (13) are arranged in a matrix with equal spacing.
4. The absorbable tracheal stent with a drug coating according to claim 1, characterized in that: At least four of the aforementioned circular skeletons (11) are provided, and the inner height of the circular skeletons (11) farther away from the middle of the housing (1) is smaller than the inner height of the circular skeletons (11) closer to the middle of the housing (1).
5. The absorbable tracheal stent with a drug-coated structure according to claim 1, characterized in that: The depth of the outer medicine groove (110) is at least one-tenth of the outer diameter of the shell (1); the longitudinal skeleton (10) and the circular skeleton (11) are of equal thickness, and their thickness is at most one-third of the depth of the outer medicine groove (110); the thickness of the shrinking film (20) is at most one-third of the thickness of the circular skeleton (11).
6. The absorbable tracheal stent with a drug-coated structure according to claim 1, characterized in that: The depth of the assembly groove (111) is equal to the depth of the outer expansion medicine groove (110), and the length of the contact film (201) is less than or equal to the outer arc length of the housing (1) corresponding to the assembly groove (111).
7. The absorbable tracheal stent with a drug-coated structure according to claim 1, characterized in that: The length of the sealing membrane (202) is greater than or equal to the width of the opening of the outer medicine trough (110).
8. The absorbable tracheal stent with a drug-coated structure according to claim 1, characterized in that: Each of the sealed membranes (202) has a vertically formed degradation groove (2021) on its inner sidewall, and the degradation groove (2021) is located in the center of the sealed membrane (202).
9. The absorbable tracheal stent with a drug coating according to claim 1, characterized in that: The width of the shrink film (20) is equal to the length of the shell (1), the length of the shrink film (20) is greater than or equal to the outer perimeter length of the shell (1), and the upper and lower edges of the sealing film (202) are integrally formed with a circular cover film (21), the thickness of the cover film (21) is less than the thickness of the sealing film (202).
10. The absorbable tracheal stent with a drug coating according to claim 9, characterized in that: The cover film (21) has a plurality of cover film flaps (22) integrally formed at the arc edge for fixing the cover film (21). The shape of the cover film (21) is similar to the cross-sectional shape of the outward medicine trough (110), and the size of the cover film (21) is greater than or equal to the cross-sectional size of the outward medicine trough (110).