CN110584850A

CN110584850A - Sinus stent

Info

Publication number: CN110584850A
Application number: CN201910762906.XA
Authority: CN
Inventors: 孙鹏; 黄秀珍; 孟秀
Original assignee: Shanghai Qimu Medical Instruments Co Ltd
Current assignee: Shanghai Qimu Medical Instruments Co Ltd
Priority date: 2019-08-16
Filing date: 2019-08-16
Publication date: 2019-12-20
Anticipated expiration: 2039-08-16
Also published as: CN110584850B

Abstract

The invention relates to the technical field of polymer stents, in particular to a sinus stent and a forming and using method thereof, aiming at overcoming the defect that the press-holding is easy to collapse and bounce in the prior art and being realized by the following technical scheme: s1, selecting a biodegradable polymer material, and dissolving to prepare a mixture; s2, extruding and redrawing the mixture through an extruder to form woven filaments; s3, starting to weave the initial configuration stent by using weaving wires to form a V-shaped weaving path; s4, fixing the V-shaped vertex of the initial configuration support to form a basic grid structure; s5, repeating the V-shaped weaving path at the vertex crossing the fixed distance until a symmetrical reticular stent is formed, wherein the tail end and the top end of the weaving wire are connected and fixed, and the cross point of the reticular stent is fixed; s6, inserting and surrounding a suture line on the surface of the mesh-shaped support, pressing the suture line, and extracting the suture line after pressing.

Description

Sinus stent

Technical Field

The invention relates to the technical field of polymer stents, in particular to a sinus stent and a forming and using method thereof.

Background

Stents may be used to hold, open or enlarge body structures such as veins, arteries, ureters, urethra, hollow body organs, nasal passages, sinus cavities, and the like. The nasal cavity is internally provided with a plurality of folds, the shape is changeable, the individual difference is very large, and the complexity of the internal space of the nasal cavity is further aggravated after pathological changes caused by diseases.

The chronic lesion of nasal sinuses, such as chronic rhinosinusitis and nasal polyp, has a very high incidence, and the operation is one of the main treatment means. With the development of medical technology, the nasal endoscope nasal sinus surgery has become the mainstream. The operation is a better treatment method, but the recovery of the function of the nasal sinuses after the operation needs a certain time, and the effect is different. This is due to the influence of the specific pathophysiological mechanisms of rhinology, which requires a long time (usually 2-3 months) of medication and follow-up after surgery. On the other hand, in the narrow space of the nasal cavity, any handling is difficult and the nasal cavity is easy to adhere, thereby the related complications are followed. The two are usually causal, which raises the difficulty for the endoscopic nasal surgery.

The existing bracket pressing and holding mainly depends on a one-step formed pressing and holding loading tool, the one-step formed pressing and holding loading tool can uniformly press and hold the whole bracket at one time, but a domestic pressing and holding device has poor pressing and holding effect when in use, and the bracket is easy to collapse and bounce, so the invention provides the sinus bracket and the forming and using method thereof.

Disclosure of Invention

Therefore, the technical problem to be solved by the invention is to overcome the defect of easy bursting of the press-holding in the prior art, thereby providing the sinus stent.

The technical purpose of the invention is realized by the following technical scheme:

a sinus stent comprising:

step S1, selecting a biodegradable polymer material, and dissolving the biodegradable polymer material by using an organic solvent to prepare a mixture;

step S2, extruding the mixture through an extruder, and then stretching to form woven filaments;

step S3, selecting a knitting machine with a longitudinal central shaft, and using the knitting yarns to start knitting the initial configuration stent to form a V-shaped knitting path;

step S4, fixing the V-shaped peak of the initial configuration bracket to form a basic grid structure, wherein the basic grid structure is formed by winding and weaving a single weaving wire or at least two single weaving wires;

step S5, repeating the V-shaped weaving path across the top points of the fixed distance until symmetrically arranged reticular brackets are formed, wherein the tail ends and the top ends of the weaving wires are fixedly connected, and the cross points of the reticular brackets are fixed;

and step S6, inserting a surrounding suture thread on the surface of the mesh-shaped support, pressing the mesh-shaped support by the suture thread, and extracting the suture thread after the pressing is finished.

Further, the biodegradable polymer material in step S1 includes, but is not limited to, polylactic acid PLA, L-PLA, polyglycolic acid/polylactic acid copolymer PGLA, polycaprolactone PCL, polyhydroxybutyrate PHBV, polyacetylglutamic acid PAGA, polyorthoester POE, polyethylene oxide/polybutylene copolymer PEO/PBTP, polylactide-co-caprolactone copolymer PLC, or polycyclohexanone PDO.

Further, the braided filament in step S2 is a polymer monofilament fiber carrying an active drug.

Further, the knitting machine in the step S3 includes a plurality of first fixing points and a plurality of second fixing points which are circumferentially and axially spaced.

Further, in the step S4, the knitting yarn is knitted sequentially around the first fixing point and the second fixing point in the circumferential direction.

Further, in the step S5, the tail end and the top end of the knitting yarn are connected and fixed by spot welding, the intersection of the mesh-shaped support is fixed by dispensing with polymer glue, both sides of the intersection are in contact with the glue, and the knitting yarn is naturally dried or baked after dispensing is completed.

Further, in the step S6, the suture thread is made of absorbable or non-absorbable material, and is used for aseptic treatment.

The technical scheme of the invention has the following advantages:

the sinus stent obtained by the forming method has good expansion compressibility, can be well adapted to the shape of a sinus cavity, has good shape practicability, is also suitable for a self-expansion stent of the sinus cavity, adopts a suture line to shrink and press the stent, reduces the occurrence of collapse and bounce when the stent is directly held by a hand or a press-holder is used, or can not be uniformly compressed, thereby avoiding the problems of influencing the structural performance of the stent, being incapable of well self-expanding after being implanted into a nasal cavity and the like.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and other drawings can be obtained by those skilled in the art without creative efforts.

FIG. 1 is a schematic view of the overall structure of a sinus support provided in one embodiment of the present invention;

fig. 2 is an expanded view of an infrastructure provided in one embodiment of the invention;

fig. 3 is an expanded view of an infrastructure provided in another embodiment of the invention;

FIG. 4 is a schematic view of the overall structure of a sinus support provided in one embodiment of the present invention;

FIG. 5 is a schematic view of the overall structure of a sinus stent provided in one embodiment of the present invention.

Description of reference numerals:

1. weaving silk; 2. a base grid structure; 3. a mesh support; 4. suture thread

Detailed Description

The technical solutions of the present invention will be described clearly and completely with reference to the accompanying drawings, and it should be understood that the described embodiments are some, but not all embodiments of the present invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

Example 1

The main raw materials mainly related to the sinus stent are biodegradable polymer materials, and the biodegradable polymer materials comprise polylactic acid (PLA), L-PLA, polyglycolic acid/polylactic acid copolymer (PGLA), Polycaprolactone (PCL), polyhydroxybutyrate valerate (PHBV), poly (acetylglutamate) (PAGA), poly (n-ester) (POE), polyethylene oxide/polybutylene copolymer (PEO/PBTP), polylactide-co-caprolactone copolymer (PLC) or Polycyclohexanone (PDO).

The forming and using method of the sinus stent comprises the following steps:

step S1, selecting biodegradable polymer material with viscosity of 0.5-5.0 dl/L and molecular weight of 50000-1000000, and dissolving the biodegradable polymer material with organic solvent to prepare mixture;

step S2, extruding the mixture by an extruder, and stretching to form a woven silk 1, wherein the woven silk 1 is a polymer monofilament fiber carrying active drugs, and the monofilament fiber consists of one or more biodegradable polymers;

step S3, selecting a knitting machine with a longitudinal central shaft, wherein the knitting machine comprises a plurality of first fixing points and a plurality of second fixing points which are arranged at intervals in the circumferential direction and the axial direction, and starting to knit the initial configuration bracket by using the knitting yarns 1 to form a V-shaped knitting path;

step S4, referring to fig. 2, weaving wires 1 sequentially surround a first fixed point and a second fixed point from top to bottom along the circumferential direction, fixing the V-shaped vertex of the initial configuration support to form a basic grid structure 2, wherein the basic grid structure 2 is formed by weaving single weaving wires 1;

step S5, repeating the V-shaped weaving path across the vertexes of the fixed interval until symmetrically arranged reticular supports 3 are formed, connecting and fixing the tail ends and the top ends of the weaving wires 1 by spot welding, fixing the cross points of the reticular supports 3, dispensing and fixing the cross points of the reticular supports 3 by polymer glue, enabling two sides of the cross points to be contacted with the glue, and naturally airing or drying after dispensing is finished, referring to figure 1, the supports can be woven into straight cylindrical supports which are completely symmetrical up and down, referring to figure 4, the supports can also be woven into hourglass-shaped supports or trapezoidal supports with trapezoidal side surfaces in bilateral symmetry, and the circumference of the top ends of the trapezoidal supports is smaller than that of the bottom ends;

step S6, the surface of the mesh-shaped support 3 is inserted and surrounded with the suture 4, the suture 4 is pressed and held by the suture 4, the suture 4 is extracted after the pressing and holding is completed, the suture 4 is made of absorbable or non-absorbable material, aseptic processing is carried out during use, the suture 4 is adopted to shrink and press the support, so that the collapse and elasticity of the support during direct holding or use of the press holder are reduced, or the uniform compression condition can not be carried out, the structural performance of the support is prevented from being influenced, the support cannot be well self-unfolded after being implanted into the nasal cavity, and the like.

The diameter of the basic grid structure 2 is limited according to requirements, a braiding machine with different first fixed points and second fixed points is selected, the braided wire 1 can also be cut and segmented, the braided wire 1 is cut in a high-pressure water jet, laser, femtosecond laser, hot melting or cutting knife mode, and meanwhile, in order to improve the drug-carrying performance of the sinus stent and realize the slow-release treatment effect of the sinus stent, polymer monofilament fibers with active drugs are adopted; the suture 4 can be directly tightened up to easily compress the sinus stent without a special compression tool after being penetrated and wound, and the structure of the mesh stent 3 can also provide elasticity for later recovery to increase the supporting force of the stent.

Example 2

The forming and using method of the sinus stent comprises the following steps:

step S4, referring to fig. 3, the braided wire 1 is braided up and down sequentially around a first fixed point and a second fixed point along the circumferential direction, and simultaneously the V-shaped vertex of the initial configuration stent is fixed to form a basic grid structure 2, the basic grid structure 2 is braided by at least two mutually folded braided wires 1, the two folded monofilaments have the same fineness in the length direction and cannot be easily detached, the sinus stent obtained by the forming method has good stretching compressibility, can be well adapted to the shape of the sinus cavity, has good shape practicability, and is also suitable for a self-expanding stent of the sinus cavity;

step S5, repeating the V-shaped weaving path across the top points of the fixed distance until symmetrically arranged mesh-shaped supports 3 are formed, connecting and fixing the tail ends and the top ends of the weaving wires 1 by spot welding, fixing the cross points of the mesh-shaped supports 3, dispensing and fixing the cross points of the mesh-shaped supports 3 by polymer glue, enabling two sides of the cross points to be in contact with the glue, and naturally airing or drying after dispensing is finished;

step S6, referring to fig. 1, the surface of the mesh-like stent 3 is inserted around the suture 4, the suture 4 is crimped by the suture 4, the suture 4 is extracted after the crimping is completed, the suture 4 is made of absorbable or non-absorbable material, and is subjected to aseptic processing during use, the suture 4 is used for shrinking and crimping the stent to reduce the occurrence of collapse and bounce when the stent is directly held by a hand or the crimp device is used, or the occurrence of uniform compression can not be performed, thereby avoiding the generation of problems such as affecting the structural performance of the stent itself, and not being able to be well self-expanded after being implanted into the nasal cavity.

It should be understood that the above examples are only for clarity of illustration and are not intended to limit the embodiments. Other variations and modifications will be apparent to persons skilled in the art in light of the above description. And are neither required nor exhaustive of all embodiments. And obvious variations or modifications therefrom are within the scope of the invention.

Claims

1. A sinus support, comprising:

step S2, extruding the mixture by an extruder, and then stretching to form the knitting yarn (1);

step S3, selecting a knitting machine with a longitudinal central shaft, and using the knitting silk (1) to start knitting the initial configuration stent to form a V-shaped knitting path;

step S4, fixing the V-shaped vertex of the initial configuration support to form a basic grid structure (2), wherein the basic grid structure (2) is formed by mutually winding and weaving a single weaving wire (1) or at least two single weaving wires (1);

step S5, repeating the V-shaped weaving path across the vertexes with fixed intervals until symmetrically arranged reticular supports (3) are formed, wherein the tail ends and the top ends of the weaving wires (1) are fixedly connected, and the cross points of the reticular supports (3) are fixed;

and step S6, inserting a surrounding suture (4) on the surface of the mesh-shaped support (3), pressing and holding the mesh-shaped support by the suture (4), and extracting the suture (4) after the pressing and holding are finished.

2. The sinus stent of claim 1, wherein the biodegradable polymer material in step S1 includes but is not limited to polylactic acid (PLA), L-PLA, polyglycolic acid/polylactic acid copolymer (PGLA), Polycaprolactone (PCL), Polyhydroxybutyrate (PHBV), Polyacetylglutamate (PAGA), Polyorthoester (POE), polyethylene oxide/polybutylene copolymer (PEO/PBTP), polylactide-co-caprolactone copolymer (PLC), or Polycyclohexanone (PDO).

3. A sinus stent according to claim 2, characterized in that the woven filaments (1) in step S2 are polymeric monofilament fibers carrying an active drug.

4. The sinus support of claim 3, wherein the braiding machine of step S3 comprises a plurality of first fixation points and a plurality of second fixation points that are circumferentially and axially spaced apart.

5. A sinus support according to claim 4, characterized in that the woven wire (1) in step S4 is woven sequentially circumferentially up and down around the first and second fixation points.

6. The sinus stent according to claim 5, wherein the ends and the top ends of the woven wires (1) are fixed by spot welding in step S5, the crossing points of the mesh stent (3) are fixed by polymer glue, both sides of the crossing points are contacted with the glue, and the mesh stent is naturally dried or baked after the glue is applied.

7. A sinus support according to claim 6, characterized in that the suture (4) in step S6 is made of absorbable or non-absorbable material and is used in aseptic processing.