CN107485472B

CN107485472B - Biodegradable stent leading-in device in nasal sinus

Info

Publication number: CN107485472B
Application number: CN201710668471.3A
Authority: CN
Inventors: 王清红; 王永立
Original assignee: Individual
Current assignee: Individual
Priority date: 2017-08-07
Filing date: 2017-08-07
Publication date: 2020-07-14
Anticipated expiration: 2037-08-07
Also published as: CN107485472A

Abstract

The invention relates to a biodegradable stent leading-in device in a nasal sinus, wherein a hollow straight pipe or a hollow bent pipe is sleeved at the front end of a hard nasal endoscope, the biodegradable stent leading-in device is carried to enter the nasal sinus channel, pus in a sinus cavity is pumped out through a hollow main catheter, and the sinus cavity is washed; the covered cotton coating can eliminate the congestion and edema of the side wall of the nasal sinus channel due to the infiltration of the liquid medicine; removing the covering film outside the stent, expanding the front end and the middle section of the stent through the air bag, adjusting the length of the middle section of the stent, and finally expanding the rear end of the stent to complete the implantation of the biological stent. The biodegradable bracket with the slow-release medicine carried on the outer side is placed into a nasal sinus channel of a maxillary sinus, a frontal sinus or a sphenoid sinus of a pathological change, so that the problem of drainage of nasal sinus cavity pus is solved, and acute and chronic nasosinusitis is treated. The biodegradable stent is put into the initial stage, the tissue around the nasal sinus passage is propped open, and the biological stent is gradually degraded without residue along with the gradual reconstruction and repair of the function of the sinus passage.

Description

Biodegradable stent leading-in device in nasal sinus

Technical Field

The invention relates to a device for treating nasosinusitis, which is characterized in that a biodegradable stent is placed into a nasal sinus channel through the device, so that the drainage of a nasal sinus cavity is unobstructed, and the acute and chronic nasosinusitis is treated: bilateral superior maxillary sinus, bilateral frontal sinus and bilateral sphenoid sinus.

Background

At present, the cause of paranasal sinusitis is mainly infection in paranasal sinuses caused by obstruction of sinus ostia due to various reasons, so that the following methods for treating acute and chronic sinusitis are mainly used: 1. local and systemic nasal cavity treatment with medicine 2. sinus sacculus dilatation to open sinus passage for unobstructed drainage 3. endoscope operation to cut pathological tissue and re-establish good ventilation drainage of nasal cavity and sinus. None of the above treatments are optimal for the following reasons: a, the nasal sinus channel is difficult to drain smoothly in drug treatment, so that the drug administration time is long and partial infection is difficult to control; b, the nasal sinus sacculus dilatation is small in wound, and the drainage problem of a nasal sinus channel cannot be completely solved; c, the nasal endoscope operation can rapidly and thoroughly remove and drain pathological tissues, but the operation relates to the face, the patient needs to be subjected to general anesthesia treatment on the tracheal cannula, pain and psychological shadow are brought to the patient, and the nasal cavity is stuffed after the operation and has a certain recurrence rate, so that the nasal endoscope operation is limited. With the mature research of degradable high molecular biological materials and the mature application of the medicine-carrying stent, the stent lead-in device is used to place the biodegradable stent into a nasal sinus channel to achieve the drainage problem of opening the nasal sinus cavity.

Disclosure of Invention

The purpose of the invention is to: the sinus stent guiding device is used under the guidance of a hard rhinoscope in a surface anesthesia mode, a biodegradable drainage stent with a medicament carried on the outer side surface is placed into a sinus channel, and a middle nasal passage or a sphenoid crypt is propped open, so that the aim of unobstructed drainage of the sinus is fulfilled, and the acute and chronic paranasal sinusitis is treated.

The purpose of the invention can be realized by the following technical scheme:

a biodegradable stent leading-in device in a nasal sinus, which comprises a pipeline and a balloon inflation tube, wherein the balloon inflation tube is arranged around the pipeline, the front end of the pipeline is made of flexible materials with side openings, the front end is connected with the following pipeline into a whole, the pipeline is separated to form two pipelines, a tail sinus cavity water injection port and a sinus cavity liquid suction port can be connected with a syringe and are respectively communicated with the two pipelines for sucking pus out of the nasal sinus cavity and injecting washing liquid for washing; the front end of the bracket leading-in device is provided with a cotton leading-in head, the cotton leading-in head carries anesthetic and medicine for contracting the blood vessel smooth muscle of nasal mucosa, the cotton leading-in head is bonded with the air bag inflation tube into a whole, the air bag inflation tube is divided into three tubes, the interiors of the three tubes are independent and are not communicated, the front end is provided with three openings, the front end air bag is communicated with the front end air bag inflation valve, the middle section air bag is communicated with the middle section air bag inflation valve, and the rear end air bag is communicated with the rear end air bag inflation valve;

a biodegradable stent is arranged on the outer sides of the front end air bag, the middle section air bag and the rear end air bag, a stent baffle is arranged at the rear end of the biodegradable stent, the cotton leading-in head, the biodegradable stent and the outer side of the stent baffle are wrapped by a coated film, a cotton coating is arranged outside the coated film, the cotton coating outside the coated film is used for carrying a medicine and a corticosteroid medicine which can cause the smooth muscle of the blood vessel of the nasal mucosa to contract, the coated film is connected with a coated film traction rope, and a blade for cutting the coated film is further arranged on the stent leading-in device;

the biodegradable stent is made of synthetic biodegradable high polymer materials and is slowly absorbed in a nasal sinus channel, and slow-release medicines are carried in the biodegradable stent; the biodegradable bracket consists of a front section, a middle section and a rear section, wherein partial U-shaped connection of the front end bracket is disconnected, so that the front end bracket has 3 or more petals to be unfolded when the front end airbag is inflated, two ends of the S-shaped connection of the middle section bracket are connected by a rotatable rotating shaft, the middle section bracket can be prolonged when a middle section bracket guide rod connected with the middle section bracket rotates outwards and rightwards, and partial U-shaped connection of the rear end bracket is disconnected, so that the rear end bracket is unfolded when the rear end airbag is inflated;

the biodegradable stent introduction device is carried by a hollow straight tube or a hollow bent tube which is hooped on the nasal endoscope for operation.

Furthermore, the shape of the cotton introduction head is a hemisphere or a bullet shape, more than two annular elastic sheets are arranged inside the cotton introduction head, and the annular elastic sheets are connected with the cotton introduction head and the air bag inflation tube.

Furthermore, pressure measuring air bags are arranged in the front end air bag inflation valve, the middle section air bag inflation valve and the rear end air bag inflation valve and used for measuring the pressure in the front end air bag, the middle section air bag and the rear end air bag.

Further, the stent guiding device enters a sinus cavity, after the sinus cavity is washed, the blade cover plate outside the blade is removed, the covering film is withdrawn backwards through a covering film traction rope, and the covering film is cut open by the blade during withdrawal until the whole covering film is withdrawn, so that the biodegradable stent and the middle-section stent guide rod are exposed.

Further, the hollow straight tube or the hollow bent tube is made of non-elastic material with two open ends, the stent guiding device can move in the hollow straight tube or the hollow bent tube, the nasal endoscope hoop is made of elastic material, and the other end of the nasal endoscope hoop is open, so that the nasal endoscope hoop 32 can be firmly clamped on the nasal endoscope 34.

Furthermore, the front section 3 rd row S-shaped connection and the rear section 3 rd row S-shaped connection of the biodegradable stent do not contain slow release drugs taking biodegradable high polymer materials as carriers, the S-shaped connection is prevented from being broken when deformed, and the rest S-shaped connections and the U-shaped stent have anti-inflammatory hyperplasia and connective tissue hyperplasia inhibiting drugs loaded in the biodegradable high polymer materials, so that the effect of slowly releasing the drugs is achieved.

The biodegradable stent introduction device in the nasal sinus comprises the following use steps:

step A: irrigation of pus in nasal sinus cavity

The specific method comprises the following steps: the nasal cavity internal surface is firstly anaesthetized by using a surface anaesthetic, a hollow straight pipe or a bent pipe is clamped at the front end of a hard nasal endoscope, the device with the graph 1 is carried, the nasal endoscope with 0-degree or 30-degree angle is decided by the habit of an operator and which specific paranasal sinus for treatment, the device is inserted into the straight pipe or the bent pipe, the straight pipe or the bent pipe enters a nasal cavity along with the nasal endoscope, a frontal sinus opening and a maxillary sinus opening are found in a middle nasal passage, a sphenoid sinus opening is found in a sphenoid pharyngeal crypt, the device with the graph 1 is inserted into a nasal sinus passage, the device slowly advances, the device with the graph 1 stops after resistance, the tail end of an inner core hollow pipe in the device is slightly forwards sent, a syringe is connected, pus in the nasal sinus cavity is pumped out by the syringe, another syringe is connected, normal saline is injected into the nasal sinus cavity for flushing. The cotton material and the coated outer cotton coating of the tip of the device of fig. 1 both carry anesthetic and corticosteroid drugs to anesthetize the mucosa surrounding the sinus passageway and to resolve mucosal hyperemia and edema.

And B: biodegradable stent is arranged in the channel

The cap of the protective blade clamped on the rod is removed, the blade on the rod is exposed, the film is drawn back outwards through a rope, the film is cut open by the blade during drawing back until the film is removed, the blade hooped on the rod is removed, the front end air bag is inflated by an injector, the front end of the bracket is opened like a petal, the device is slightly withdrawn outwards, the front end petal is attached to the inner wall of a nasal sinus, the middle section air bag is inflated by the injector, 2 guide rods are pulled outwards and rightwards under the observation of an intranasal endoscope, the guide rods are moved outwards and rightwards, the length of the middle section of the bracket is adjusted, the outer edge of the middle section stops after reaching an outer opening, finally, the rear end air bag is inflated, and after the bracket is fully expanded, the device shown in the figure 1 is taken out after air in 3.

The sphenoid sinus has short sinus tract, so that the middle section of the corresponding biological scaffold is short, the length can be fixed, and the length does not need to be adjusted. Most of the sphenoid sinus opening is visible under direct endoscopic visualization and a small portion is covered by the superior and middle turbinates.

According to the Beijing friendship Hospital radiological Lixiaoqiang etc. through the paranasal sinus high resolution CT image of the normal adult examinee, the upper air three-dimensional volume reconstruction is carried out on the original image, the average volume of the gasification cavity of the maxillary sinus, the frontal sinus and the sphenoid sinus is measured to be 17.43ml, 3.42ml and 5.98ml respectively, the diameter in the cavity of the paranasal sinus is 1.8cm-3.2cm, the irregularity of the sinus cavity is removed, and the diameter is about 1.3cm-2.5cm, thereby the length of the cotton-shaped lead-in head 2 and the size of the front section of the biological stent in the stent introduction device figure 1 can be estimated approximately. In actual operation, the anatomical variation of the nose and the paranasal sinuses needs to be warned, and the judgment can be carried out through CT examination of the paranasal sinuses.

Most of biodegradable stent materials are polylactic acid, polyglycolic acid, chitosan, polycaprolactone and some copolymers such as polylactic acid/polyglycolic acid copolymer at present, the stent with proper thermal and mechanical properties and degradation speed can be obtained by blending or copolymerizing the polylactic acid, the polyglycolic acid, the chitosan and the polycaprolactone, and the high polymer materials have good biocompatibility, can be completely biodegraded and are metabolized into carbon dioxide and water. The magnesium alloy biodegradable stent can also be selected.

In order to control the slow release of the drugs, the anti-inflammatory drugs, namely steroidal anti-inflammatory drugs, such as dexamethasone and antiproliferative drugs, such as paclitaxel and rapamycin, carried on the stent are mostly synthesized high molecular materials as carriers for slow release of the drugs at present.

The invention has the advantages that: the biological stent is arranged in the nasal sinus passage through the sinus stent leading-in device in the initial stage, the tissues around the nasal sinus passage are propped open, the stent is gradually degraded without residue in half a year to 3 years along with the gradual reconstruction and repair of the sinus function. The operation is simple and safe, the local surface anesthesia mode is adopted, the implanted bracket can be completely biodegraded, the diseased tissue is not damaged or excised, the sequelae are not left, the hospital is not required to be hospitalized, the patient can be out of the hospital after the outpatient treatment, and the head and neck CT and nuclear magnetic resonance examination are not influenced.

Drawings

FIG. 1 is a schematic structural diagram of an apparatus for practicing the present invention;

FIG. 2 is an enlarged view of a portion of the front end of FIG. 1;

FIG. 3 is an enlarged view of a portion of the middle section of FIG. 1;

FIG. 4 is an enlarged cross-sectional view of the device of FIG. 1 taken along line A-A;

FIG. 5 is a schematic structural diagram of a second embodiment of the present invention;

FIG. 6 is a side view of FIG. 5;

FIG. 7 is an expanded view of the carrying stand of FIG. 1;

in the drawings: 1. a pipeline; 2. a cotton insertion head; 3. an annular spring plate; 4. an air bag inflation tube; 5. a front end airbag; 6. a middle section air bag; 7. a rear end airbag; 8. a biodegradable scaffold; 9. coating a film; 10. a cotton coating; 11. the outer edge of the middle section bracket; 12. a middle section bracket guide rod; 15. a bracket baffle; 16. coating a film on a traction rope; 17. a blade; 18. a blade cover plate; 19. a handle at the outlet end of the guide rod; 21. a pressure measuring air bag; 24. a sinus cavity water injection port; 25. sinus cavity fluid aspiration port; 26. a front end airbag inflation valve; 27. a middle section air bag inflation valve; 28. a rear end airbag inflation valve; 30. a hollow bent pipe; 31. a hollow straight tube; 32. a nasal endoscope loop; 34. a hard nasal endoscope; 41. the third row of the front section is connected in an S shape; 42. the third row of the rear section is in S-shaped connection; 43. medicated S-shaped connection; 44. u-shaped connection; 45. disconnection of U-shaped support

Detailed Description

The present invention will be described in detail below with reference to the accompanying drawings and specific embodiments.

The nasal cavity inner surface is narcotized by surface anesthetic, a non-elastic material hollow straight tube 31 with two open ends or a bent tube 30 with one end bent at 30-45 degrees is clamped at the front end of a hard nasal endoscope 34, a sinus stent leading-in device is carried, the nasal endoscope with 0-degree or 30-degree angle is determined and selected according to the specific paranasal sinus of an operator's habit and treatment, the stent leading-in device is inserted into the straight tube or the bent tube, the frontal sinus and maxillary sinus openings are found in the middle nasal passage along with the nasal endoscope entering the nasal cavity, the sphenoid sinus opening is found at the sphenoidal crypt, the front end of the stent leading-in device is inserted into the nasal sinus passage and slowly moves forwards and stops after resistance, the tail end of a pipeline 1 in the stent leading-in device is slightly moved forwards, a sinus cavity liquid suction port 25 is connected with an injector, pus in the nasal cavity is extracted by the injector, a sinus cavity water injection port 24 is connected with, then the liquid is pumped out from the sinus cavity liquid suction port, and the flushing is repeated for a plurality of times until the liquid in the pumped cavity is clear, and the pipeline 1 is slightly pumped back outwards after the flushing is finished.

The soft leading-in head 2 at the front end of the sinus tract stent leading-in device is formed by soft materials with slight elasticity and is adhered with the air sac inflating tube 4 into a whole, the shape is hemispherical or bullet head, more than two annular elastic sheets 3 are arranged in the soft leading-in head 2 and are connected with the air sac inflating tube 4, the soft leading-in head 2 is prevented from shifting with the air sac inflating tube 4 or falling into sinus cavities when entering and exiting the sinus cavities, the soft leading-in head 2 carries anesthetic and medicine for contracting the blood vessel smooth muscle of nasal mucosa, such as ephedrine, the soft coating 10 outside the covering film 9 of the stent carries the medicine for contracting the blood vessel smooth muscle of nasal mucosa and corticosteroid medicine, and the congestion of the mucosa is relieved.

Removing a blade cover plate 18 clamped on a sinus stent lead-in device rod from a blade 17 to expose the blade, drawing back a stent outer coating 9 outwards through a stent outer coating traction rope 16, splitting the coating during drawing back until the whole stent outer coating is removed to expose a biological stent 8, simultaneously exposing two middle section stent guide rods 12, removing the blade hooped on the rod, inflating a front end air bag 5 through a front end air bag inflation valve 26 by using an injector, expanding the front end of the stent in a petal shape under the action of the air bag, slightly drawing back a stent lead-in device to enable the front end stent to be attached to the inner wall of a nasal sinus, inflating a middle section air bag 6 through a middle section air bag inflation valve 27 by using the injector, holding an outlet end handle 19 of the middle section stent guide rod 12 to draw the two middle section stent guide rods outwards and rightwards so that the guide rods outwards move rightwards under the observation of a nasal endoscope to adjust the length of the middle section of the stent, and (3) stopping seeing the outer edge 11 of the middle section bracket, finally inflating the rear end airbag 7 through a rear end airbag inflation valve 28, unfolding the rear end of the bracket to expand the rear end of the bracket in a way of separating the middle turbinate from the lower turbinate or expanding the butterfly pharynx recess at the exit of the sphenoid sinus, evacuating the gas in the front end airbag 5, the middle section airbag 6 and the rear end airbag 7 through a front end airbag valve 26, a middle section airbag valve 27 and a rear end airbag valve 28, slightly sending 2 middle section bracket guide rods forward, removing a loop rope at the front end, drawing out a bracket guiding device, and completing the placement of the bracket.

The air bag inflation tube 4 of the stent leading-in device forms three tubes which are independent and not communicated with each other inside, so that the front end air bag 5 is communicated with the front end air bag inflation valve 26, the middle section air bag 6 is communicated with the middle section air bag inflation valve 27, the rear end air bag 7 is communicated with the rear end air bag inflation valve 28, and the pressure measuring air bags 21 are arranged in the front end, middle section and rear end air bag inflation valves, so that the pressure in the front end, middle section and rear end air bags can be measured.

The biological stent is made of synthetic biodegradable high polymer materials, is slowly absorbed in a nasal sinus channel, has the absorption period of half to three years, does not contain slow release drugs taking the biodegradable high polymer materials as carriers except for the front-section third-row S-shaped connection 41 and the rear-section third-row S-shaped connection 42 in the stent, avoids the fracture when the S-shaped connection deforms, and the rest S-shaped connections 43 and the U-shaped stent 44 have anti-inflammatory hyperplasia and connective tissue hyperplasia inhibiting drugs loaded in the biodegradable high polymer materials, thereby playing the effect of slowly releasing the drugs.

The partial U-shaped connection and disconnection 45 of the front end stent of the biological stent is to make the front end stent expand like 3 or more petals when the front end airbag 5 is inflated, and the partial U-shaped connection and disconnection 45 of the rear end stent of the biological stent is to make the rear end stent separate up and down when the rear end airbag 7 is inflated.

The two ends of the S connection of the middle section bracket are connected by a rotatable rotating shaft, and the middle section bracket can be extended when being rotated outwards and rightwards by the middle section bracket guide rod 12 so as to adapt to patients with different sinus lengths.

Claims

1. The utility model provides a biodegradable support gatherer in nasal sinus, its characterized in that: the stent leading-in device comprises a pipeline (1) and an air bag inflation tube (4), the air bag inflation tube (4) is arranged around the pipeline (1), the front end of the pipeline (1) is made of flexible materials with an opening on the side surface, the front end is connected with the pipeline behind into a whole, two pipelines are formed in the pipeline (1) at intervals, a tail end sinus cavity water injection port (24) and a sinus cavity liquid suction port (25) can be connected with injectors and are respectively communicated with the two pipelines for sucking pus out of a sinus cavity and injecting washing liquid for washing;

the front end of the bracket leading-in device is provided with a cotton leading-in head (2), the cotton leading-in head (2) carries anesthetic and medicine for enabling the smooth muscle of the blood vessel of the nasal mucosa to contract, the cotton leading-in head (2) is bonded with the air bag inflation tube (4) into a whole, the air bag inflation tube (4) is divided into three tubes which are independent and not communicated with each other, the front end is provided with three openings, so that the front end air bag (5) is communicated with the front end air bag inflation valve (26), the middle section air bag (6) is communicated with the middle section air bag inflation valve (27), and the rear end air bag (7) is communicated with the rear end air bag inflation valve (28);

a biodegradable support (8) is arranged on the outer sides of the front end air bag (5), the middle section air bag (6) and the rear end air bag (7), a support baffle (15) is arranged at the rear end of the biodegradable support (8), the cotton introduction head (2), the biodegradable support (8) and the support baffle (15) are wrapped by a covering film (9), a cotton coating (10) is arranged outside the covering film (9), the cotton coating (10) outside the covering film (9) is used for carrying a medicine for enabling the smooth muscle of the blood vessel of the nasal mucosa to contract and a corticosteroid medicine, the covering film (9) is connected with a covering film traction rope (16), and a blade (17) for cutting the covering film (9) is further arranged on the support introduction device;

the biodegradable stent (8) is made of synthetic biodegradable high polymer materials and is slowly absorbed in a nasal sinus channel, and slow-release medicines are carried in the biodegradable stent; the biodegradable bracket consists of a front section, a middle section and a rear section, wherein the partial U-shaped connection and disconnection (45) of the front end bracket leads the front end bracket to open three or more petals when the front end airbag (5) is inflated, the two ends of the S-shaped connection of the middle section bracket are connected by a rotatable rotating shaft, the middle section bracket can be prolonged when a middle section bracket guide rod (12) connected with the middle section bracket rotates outwards and rightwards, and the partial U-shaped connection and disconnection (45) of the rear end bracket leads the rear end bracket to open when the rear end airbag (7) is inflated;

the biodegradable stent guiding device is carried by a hollow straight pipe (31) or a hollow bent pipe (30) hooped on a nasal endoscope (34) for operation.

2. The sinus intra-meatus biodegradable stent introduction device according to claim 1, wherein: the shape of the cotton introduction head (2) is hemispherical or bullet-shaped, more than two annular elastic sheets (3) are arranged inside the cotton introduction head (2), and the annular elastic sheets (3) are connected with the cotton introduction head (2) and the air bag inflation tube (4).

3. The sinus intra-meatus biodegradable stent introduction device according to claim 1, wherein: all be equipped with pressure measurement gasbag (21) in front end gasbag inflation valve (26), middle section gasbag inflation valve (27) and rear end gasbag inflation valve (28), pressure measurement gasbag (21) are used for measuring pressure in front end gasbag (5), middle section gasbag (6) and rear end gasbag (7).

4. The sinus intra-meatus biodegradable stent introduction device according to claim 1, wherein: the stent guiding device enters a sinus cavity, after the sinus cavity is washed, a blade cover plate (18) outside the blade (17) is removed, the tectorial membrane (9) is withdrawn backwards through a tectorial membrane traction rope (16), and the tectorial membrane (9) is cut open by the blade (17) in the withdrawal process until the whole tectorial membrane (9) is removed, so that the biodegradable stent (8) and the middle section stent guide rod (12) are exposed.

5. The sinus intra-meatus biodegradable stent introduction device according to claim 1, wherein: the hollow straight tube (31) or the hollow bent tube (30) is made of non-elastic material with two open ends, the stent guiding device can move in the hollow straight tube (31) or the hollow bent tube (30), the nasal endoscope hoop (32) is made of elastic material, and the other end of the nasal endoscope hoop (32) is open, so that the nasal endoscope hoop (32) can be firmly clamped on the nasal endoscope (34).

6. The sinus intra-meatus biodegradable stent introduction device according to claim 1, wherein: the front-section third-row S-shaped connection (41) and the rear-section third-row S-shaped connection (42) of the biodegradable stent (8) do not contain slow-release drugs taking biodegradable high polymer materials as carriers, the slow-release drugs are prevented from being broken when the S-shaped connections deform, and the rest S-shaped connections (43) and the U-shaped stent (44) are loaded with anti-inflammatory hyperplasia and connective tissue hyperplasia inhibiting drugs into the biodegradable high polymer materials, so that the effect of slowly releasing the drugs is achieved.