CN115645111A

CN115645111A - Absorbable shapeable trachea external fixing support

Info

Publication number: CN115645111A
Application number: CN202211365716.2A
Authority: CN
Inventors: 孙善权; 许伟滨; 黄景思; 饶姣; 刘琴
Original assignee: Guangdong Maternal and Child Health Hospital
Current assignee: Guangdong Maternal and Child Health Hospital
Priority date: 2022-10-31
Filing date: 2022-10-31
Publication date: 2023-01-31

Abstract

The outer fixing support comprises a support body, a plurality of grooves and a plurality of grooves, wherein the support body comprises a cross shape, a straight shape and a herringbone shape; the inner layer and the outer layer of the bracket body are respectively coated with an inner membrane protective layer and an outer membrane protective layer. The invention has various shapes and wide application range, is suitable for implantation for tracheal stenosis treatment of patients of different ages, can be sutured by an external fixing device with corresponding size according to the formed trachea in the operation and carry out external fixation, brings convenience to surgeons, can prevent inner cavity blockage after being implanted into the trachea of a human body due to the medicine carrier, can well form the trachea of the patient after implantation aiming at the carina and the patients with left and right bronchi, has smooth sputum discharge, and can successfully pass through the perioperative period and the recovery period, thereby providing favorable technical support for the rehabilitation treatment of the patient.

Description

Absorbable shapeable trachea external fixing support

Technical Field

The invention relates to the field of medical equipment, in particular to an absorbable shapeable trachea external fixing support.

Background

In clinical medicine, patients suffering from various congenital tracheal stenosis are mostly abnormal tracheal development, which is a respiratory tract malformation capable of threatening life, usually, the narrow section can be short or long, some patients can reach a trachea bulge part, the patients with extremely narrow trachea and even locked patients can not survive after birth, the disease can be manifested as wheezing and dyspnea, and most of the disease appears in early infant.

At present, congenital tracheal stenosis treatment is divided into surgical treatment and stent implantation, under the actual condition, postoperative complications exist in the surgical treatment, particularly after long-section tracheal stenosis or bridge bronchial stenosis and other reconstruction bulge forming operations occur, the probability of occurrence of 8-shaped change or lip-shaped change of a trachea exists, in this way, softening of the trachea easily occurs, repeated respiratory tract infection and granulation tissue hyperplasia of a patient occur, and great influence is brought to the recovery of the patient. The mode of implanting the support to patient's trachea can play the narrow trachea of expansion through implanting the support in the affected part, makes the lumen unobstructed, and patient's respiratory function resumes normally, because the postoperative complication of support treatment trachea stenosis is few, and is little to patient's wound, therefore this technique has obtained effective development. Although the existing tracheal stent has more advantages, the existing tracheal stent is limited by the structure and has some specific defects, the main table is that the existing tracheal stent has too many supporting surfaces, the supporting surfaces and the friction surfaces in the trachea are increased, so that inflammation infection is easily caused, the trachea of a newborn or an infant is short, and after the implanted stent is formed, the trachea is further shortened, and the supporting rings (the supporting surfaces) are too many but not enough trachea to place the stent and suture. Therefore, the existing support is more suitable for older children and even adults, and can not achieve satisfactory effect for infants. Finally, the existing stent can only perform external fixation on the airway after implantation, lacks the formation of left and right bronchi, and has more limited application range. In conclusion, it is necessary to provide a tracheal stent which is convenient to implant, suitable for people including infants, and capable of achieving a good treatment effect after implantation.

Disclosure of Invention

In order to overcome the defects of the prior tracheal stent caused by the structure limitation as background, the invention provides the absorbable plastic tracheal external fixation stent which can be prepared into various shapes, has wide application range, is suitable for the treatment and implantation of patients with tracheal stenosis without similar or old age, can be sutured and externally fixed by an external fixing device with corresponding size formed according to the formed tracheal shaping in the operation, brings convenience to surgeons, can well form the trachea of the patient after implantation and discharge phlegm smoothly aiming at the patients with the carina and the left and right bronchi, and can successfully pass through the perioperative period and the recovery period, thereby providing technical support for the rehabilitation treatment of the patient.

The technical scheme adopted by the invention for solving the technical problem is as follows:

the absorbable shapeable trachea external fixing support is characterized in that a support body comprises a cross shape, a straight shape and a herringbone shape, and the support body is of a hollow structure; the outer surface of the bracket body is provided with a plurality of holes to form a supporting surface, and the outer cambered surfaces of the cross-shaped, straight-line-shaped and herringbone bracket bodies are provided with an inward concave groove at certain intervals; the inner layer and the outer layer of the stent body are respectively plated with an inner membrane protective layer and an outer membrane protective layer, the inner membrane protective layer is made of polytetrafluoroethylene, and the outer membrane protective layer is respectively made of polytetrafluoroethylene, a magnetic layer and a paclitaxel drug solution layer from inside to outside; the integral thickness of the inner film protective layer and the outer film protective layer is between 35um and 260 um; the pore diameter of the micropores on the outer surface of the bracket body is between 0.5mm and 1 mm; the thickness of the medicine layer is between 20 and 100 um; the inner layer of the inner film protective layer is also plated with an X-ray developer.

Further, the stent body shape is not limited to cross, in-line, and herringbone, but can be any shape.

Furthermore, the wall thickness of the linear bracket body is 0.1-0.3mm, the upper end and the lower end of the herringbone bracket body are of arc surface structures, the height of the arc surface is 0.6-1mm, the interval between every two grooves is 1-2mm, and the outer diameter of the herringbone bracket body is 2.5-3 cm and the height is 4-5 cm.

Furthermore, the wall thickness of the cross-shaped support body is 0.1-0.3mm, the left and right parts of the upper end and the lower end of the cross-shaped support body are of arc surface structures, the height of the arc surface is 0.6-1mm, the interval between every two grooves is 1-2mm, and the outer diameter of the cross-shaped support body is 2.5-3 cm and the height is 4-5 cm.

Furthermore, the wall thickness of the herringbone body is 0.1-0.3mm, the left and right parts of the upper end and the lower end of the herringbone support body are of arc surface structures, the height of the arc surfaces is 0.6-1mm, the interval between every two grooves is 1-2mm, and the outer diameter of the herringbone support body is 2.5-3 cm and the height is 4-5 cm.

Further, the magnetic material of the outer film protective layer is one or a mixture of multiple of nanoscale iron, cobalt, nickel and gadolinium powder.

Furthermore, the stent body is made of one of nickel-titanium alloy, cobalt alloy, stainless steel and high polymer materials, and can also be made of human body absorbable materials.

Further, the support body can be also woven by adopting metal wires.

The invention has the beneficial effects that: the invention has various shapes, wide application range, is suitable for implantation of tracheal stenosis treatment of patients of different ages, can be sutured by an external fixing device with corresponding size according to the formed trachea shape in operation for external fixation, brings convenience to surgeons, can prevent inner cavity blockage after being implanted into the trachea of a human body due to the medicine carrier, can well form the trachea of the patient after implantation aiming at the carina and the patients with left and right bronchi, has smooth sputum discharge, can smoothly pass through perioperative period and recovery period, and has favorable technical support for rehabilitation treatment of the patient. Based on the above, the invention has good application prospect.

Drawings

The invention is further illustrated below with reference to the figures and examples.

FIG. 1 is a schematic diagram of a cruciform structure of the present invention.

FIG. 2 is a schematic view of the whole structure and a partial enlargement of the present invention.

FIG. 3 is an enlarged partial schematic view of the chevron-shaped overall structure of the present invention.

Detailed Description

As shown in fig. 1, 2 and 3, the absorbable shapeable trachea external fixation stent comprises a stent body with various shapes such as a cross shape 1, a straight shape 2 and a herringbone shape 3, wherein the stent body 1 is a cylindrical hollow structure; the outer surface of the bracket body 1 is provided with a plurality of holes (not shown in the figure) to form a supporting surface, and the outer arc surfaces of the cross-shaped 1, the straight-line-shaped 2 and the herringbone 3 bracket bodies are provided with an inward concave groove 4 at certain intervals; an inner membrane protective layer 5 and an outer membrane protective layer 6 are respectively plated on the surface of the inner layer and the surface of the outer layer of the bracket body, the inner membrane protective layer 5 is made of polytetrafluoroethylene, and the outer membrane protective layer 6 is respectively made of polytetrafluoroethylene, a magnetic layer and a paclitaxel drug solution layer from inside to outside; the overall thickness of the inner film protection layer 5 and the outer film protection layer 6 is between 35um and 260um (120 um in the embodiment); the pore diameter of the micropores on the outer surface of the stent body is between 0.5mm and 1mm (0.6 mm in the embodiment); the thickness of the drug layer is between 20-100um (80 mm in this embodiment); the inner layer of the inner membrane protective layer 5 is also plated with an X-ray developer (which is convenient for subsequent X-ray fluoroscopy detection after implantation).

As shown in fig. 1, 2, and 3, the stent body profile is not limited to a cross, a line, and a chevron, but can be any profile. The wall thickness of the linear bracket body 2 is 0.1-0.3mm (0.2 mm in the embodiment), the upper end and the lower end of the linear bracket body 3 are of an arc surface structure, the height of the arc surface is 0.6-1mm (08 mm in the embodiment), the interval between every two grooves is 1-2mm (1 mm in the embodiment), the outer diameter of the linear bracket body 4 is 2.5cm-3cm (2.8 mm in the embodiment), and the height is 4cm-5cm (4.5 cm in the embodiment). The outer diameter of the herringbone bracket body 3 is between 2.5cm and 3cm (2.8 mm in the embodiment) and the height is between 4cm and 5cm (4.5 cm in the embodiment), the upper end and the lower end of the herringbone bracket body 3 are of arc surface structures, the height of the arc surface is between 0.6mm and 1mm (08 mm in the embodiment), and the interval between every two grooves is between 1mm and 2mm (1 mm in the embodiment). The wall thickness of the cross-shaped support body 1 is 0.1-0.3mm (0.2 mm in the embodiment), the left and right parts of the upper end and the lower end of the cross-shaped support body 2 are of arc surface structures, the height of the arc surface is 0.6-1mm (0.8 mm in the embodiment), the interval between every two grooves is 1-2mm (1 mm in the embodiment), the outer diameter of the cross-shaped support body 2 is 2.5cm-3cm (2.7 cm in the embodiment), and the height is 4cm-5cm (4.5 mm in the embodiment). The magnetic material of the outer film protective layer 6 is one or a mixture of nano-scale iron, cobalt, nickel and gadolinium powder. The stent body is made of one of nickel-titanium alloy, cobalt alloy, stainless steel and high polymer material, and can also be made of human body absorbable material (absorbable material is adopted in the embodiment). The cross-shaped, straight-line-shaped and herringbone support bodies can also be woven by metal wires.

As shown in fig. 1, 2 and 3, the inner protective film layer 5 adopts a dip coating method for film coating, which is divided into three film coating operations, so that a better film coating effect can be realized; the outer protective film layer 6 adopts a process of coating films by a dip coating method, which is divided into three film coating operations; the medicine layer is coated on the outer layer of the outer layer protective film and the like for multiple times by adopting a coating process, and the paclitaxel medicine solution coated each time is dried and then coated next time, so that the medicine layer is finally formed. In the production of the invention, an inner layer coating 5 is firstly formed on the outer surface of the stainless steel nickel-titanium alloy stent body 1, and the outer surface is coated with Polyurethane (PU), and the adopted process mainly comprises a dip-coating method. And (4) putting the support body coated with the inner and outer protective layers into a drying oven for drying to obtain a finished support. The method for implanting the tracheal stent in the human body is the same as that of the existing tracheal stent. The film-coated material is corrosion-resistant, non-adhesive and non-toxic (artificial blood vessels and visceral organs can both use the material and have no adverse reaction after being placed in a human body for a long time), improves the biocompatibility with the human body after being placed in the human body, has smooth surface, is convenient to implant and ensures that no residue is formed on the surface after being implanted; the stent can be better protected by the inner protective film layer 5 and the outer protective film layer 6, and the stent can be slowly released to the trachea by the paclitaxel drug, so that the probability of stent blockage caused by liquid in the trachea is prevented. The invention has various shapes and wide application range, is suitable for implantation of tracheal stenosis treatment of patients of different ages without the use of the patient, has good skin-friendly property, can be absorbed, has little influence on tracheal tissues, can be sutured and externally fixed by an external fixing device with a corresponding size according to the formed trachea shape in the operation, brings convenience to surgeons, can reduce the probability of inner wall blockage after being implanted into the trachea of the human body due to the medicine carrier, can soften the collapsed trachea by externally fixing and supporting the trachea aiming at the patient with the protuberant process and the formation of left and right bronchi after the implantation, recovers the normal trachea lumen shape and cilium movement function, reduces the airflow resistance, avoids the formation of granulation due to long-term stimulation of tracheal mucosa foreign matters, is easy for sputum to discharge the trachea of the patient to form good shape, discharges the sputum smoothly, and can smoothly pass through the perioperative period and the recovery period, thereby providing favorable technical support for the rehabilitation treatment of the patient.

While there have been shown and described what are at present considered the fundamental principles and essential features of the invention and its advantages, it will be apparent to those skilled in the art that the invention is not limited to the details of the foregoing illustrative embodiments, but is capable of other specific forms without departing from the spirit or essential characteristics thereof. The present embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.

Furthermore, it should be understood that although the present specification describes embodiments, these embodiments are not intended to encompass only a single embodiment, and such description is merely for clarity, and those skilled in the art will be able to refer to the specification as a whole, and the embodiments may be suitably combined to form other embodiments as will be appreciated by those skilled in the art.

Claims

1. The absorbable shapeable trachea external fixation support is characterized in that a support body comprises a cross shape, a straight shape and a herringbone shape, and the support body is of a hollow structure; the outer surface of the bracket body is provided with a plurality of holes to form a supporting surface, and the outer cambered surfaces of the cross-shaped, straight-line-shaped and herringbone bracket bodies are provided with an inward concave groove at certain intervals; the inner layer and the outer layer of the bracket body are respectively plated with an inner membrane protective layer and an outer membrane protective layer, the inner membrane protective layer is made of polytetrafluoroethylene, and the outer membrane protective layer is respectively made of polytetrafluoroethylene, a magnetic layer and a paclitaxel drug solution layer from inside to outside; the integral thickness of the inner film protective layer and the outer film protective layer is between 35um and 260 um; the pore diameter of the micropores on the outer surface of the bracket body is between 0.5mm and 1 mm; the thickness of the medicine layer is between 20 and 100 um; the inner layer of the inner film protective layer is also plated with an X-ray developer.

2. The absorbable shapeable tracheal external fixation stent of claim 1, wherein the stent body has a shape not limited to cross, in-line, or herringbone shape, but any shape.

3. The absorbable shapeable trachea external fixation stent according to claim 1, wherein the wall thickness of the linear stent body is between 0.1 mm and 0.3mm, the upper end and the lower end of the herringbone stent body are of arc surface structures, the height of the arc surface is between 0.6mm and 1mm, the interval between every two grooves is between 1mm and 2mm, and the outer diameter of the herringbone stent body is between 2.5cm and 3cm and the height is between 4cm and 5 cm.

4. The absorbable shapeable trachea external fixation stent according to claim 1, wherein the wall thickness of the cross stent body is between 0.1 mm and 0.3mm, the left and right parts of the upper end and the lower end of the cross stent body are in a circular arc surface structure, the height of the circular arc surface is between 0.6mm and 1mm, the interval between every two grooves is between 1mm and 2mm, and the outer diameter of the cross stent body is between 2.5cm and 3cm and the height is between 4cm and 5 cm.

5. The absorbable shapeable tracheal external fixation stent of claim 1, wherein the wall thickness of the herringbone body is between 0.1 mm and 0.3mm, the left and right parts of the upper end and the lower end of the herringbone body are of arc surface structures, the height of the arc surface is between 0.6mm and 1mm, the interval between every two grooves is between 1mm and 2mm, and the outer diameter of the herringbone body is between 2.5cm and 3cm and the height is between 4cm and 5 cm.

6. The absorbable shapeable tracheal external fixation stent of claim 1, wherein the magnetic material of the outer membrane protective layer is a mixture of one or more of nanoscale iron, cobalt, nickel, and gadolinium powders.

7. The absorbable shapeable endotracheal tube fixing stent according to claim 1, wherein the stent body is made of one of nickel-titanium alloy, cobalt alloy, stainless steel, polymer material, and human absorbable material.

8. The absorbable shapeable endotracheal tube fixing stent according to claim 1, wherein the stent body is further braided with a metal wire.