CN112972083B - Pulmonary artery stent for children - Google Patents

Abstract

The application relates to a pulmonary artery stent for infants, which is of a balloon dilatation type and comprises a plurality of net-shaped unit sections and connecting rods, wherein the unit sections comprise a plurality of section rods which are connected end to end, and the unit sections are encircled into a ring shape; the connecting rod is connected in adjacent unit festival, each festival pole quantity is 12 to 30 in the unit festival, and two festival pole junctions are the circular arc transition, the connecting rod encircles to evenly distributed along the unit festival, at least one interval the circular arc transition sets up the junction of a connecting rod, and is adjacent junction on the unit festival is in the connecting rod corresponding connection. The pulmonary artery stent for the infants has good flexibility and can meet the requirements of interventional therapy of infant patients.

Description

Pulmonary artery stent for children

Technical Field

The application relates to the technical field of blood vessel intervention, in particular to a pulmonary artery stent for infants.

Background

Pulmonary stenosis includes congenital and acquired stenosis as its cause of disease. The congenital stenosis is usually caused by congenital heart disease with pulmonary circulation dysplasia, such as Faluo tetrad syndrome, pulmonary artery occlusion and the like, and the acquired stenosis is usually caused by surgical operations, such as anastomotic stenosis and the like after the surgical operations.

The physiological characteristics of the pulmonary artery are as follows: low pressure, thin vessel wall, large size, large contraction diameter, and venous blood inside. The tissue structure of the stenotic site is usually caused by postoperative scar or hyperplasia, and is more difficult to expand than normal vascular tissue. Meanwhile, the diameter of the pulmonary artery is relatively large, and the diameter difference between the proximal end and the distal end is possibly large. The stent needs to be cylindrical or conical after expansion to ensure that the stent adheres to the wall to conform to the anatomy of the pulmonary artery without causing excessive irritation to the vessel wall. However, at present, no special pulmonary artery stent is seen in clinical at home and abroad, and all the stents are replaced, such as a CP stent with an indication of aortic stenosis or a biliary tract stent with biliary tract stenosis, and the like, and the CP stent cannot meet the requirement of pulmonary artery stenosis due to the factors of poor stent flexibility, overhigh foreshortening rate, high fracture rate, incomplete coverage and the like; in the latter, because the stent has a small diameter range, small supporting force and large shortening, and cannot adapt to narrow pulmonary artery with variable anatomical structures, a pulmonary artery stent which can be expanded according to the anatomical structures of the pulmonary artery is urgently needed.

Particularly, when the stent is applied to infants, the blood vessels at the tail end of the pulmonary artery of the infants are tiny and tortuous, and the stent is relatively difficult to push to a target position; in addition, the body growth and development of the infant are changed greatly, the blood vessel can continue to grow after treatment, and passive stenosis at the position of the stent is caused in the later period, so that higher requirements are put forward on the design of the pulmonary artery stent.

Disclosure of Invention

In order to solve the above technical problems, an object of the present invention is to provide a pulmonary artery stent for infants, which has good flexibility and can meet the interventional therapy requirements of infant patients.

Another object of the present invention is to provide a pulmonary artery stent for infants, which has good flexibility and small outer diameter after being crimped.

The application provides a pulmonary artery stent for infants, which is of a balloon expansion type and comprises a plurality of net-shaped unit sections and connecting rods, wherein the unit sections comprise a plurality of section rods which are connected end to end, and the unit sections are encircled into a ring shape; the connecting rod is connected in adjacent unit festival, each festival pole quantity is 12 to 30 in the unit festival, and two festival pole junctions are the circular arc transition, the connecting rod is along unit festival ring to evenly distributed, at least one interval the circular arc transition sets up the junction of a connecting rod, and is adjacent junction on the unit festival with connecting rod corresponding connection.

According to an embodiment of the present application, the bracket includes two kinds of the connecting rods having different circumferential inclination directions.

According to an embodiment of the application, the support comprises two connecting rods with different circumferential inclination directions, and the connecting rods in the two directions are arranged in a staggered mode along the axial direction of the support.

According to an embodiment of the present application, the connecting rod is an S-shaped, Z-shaped or Ω -shaped connecting rod.

According to an embodiment of the present application, the number of the segment rods in each unit segment is 18 to 24.

According to an embodiment of the application, the two ends of the support are end unit sections, and a middle unit section is arranged between the two end unit sections. The radius of the circular arc transition of the end unit sections at the two ends of the support is larger than or equal to that of the circular arc transition of the middle unit section.

According to an embodiment of the present application, the circumferential inclination directions of the connecting rods between the two end unit sections and the middle unit section are different.

According to an embodiment of the application, the length of the single section in the middle unit section is 2-5 mm, and the length of the single section in the end unit section is equal to or less than that of the single section in the middle unit section.

According to an embodiment of the application, the rod width of each of the section rods in the middle unit section is greater than or equal to the rod width of each of the section rods in the end unit sections.

According to an embodiment of the present application, each of the joints is disposed at a starting point of the arc transition, or each of the joints is disposed at a middle portion of the arc transition.

Compared with the prior art, the technical scheme provided by the embodiment of the application has the following advantages:

the embodiment of the application provides in each unit festival section in the support festival quantity control 12 to 30 between, reduces the quantity of connecting rod simultaneously, configures to 2 festival poles at least at the interval and sets up, and the support design is open ring structure, and open ring structure sets up 1 connecting rod for at least 1 circular arc transition at the interval between two adjacent unit festival promptly, so, the support of embracing the state of holding will have better compliance.

Meanwhile, the post expansion can be realized by adopting an open-loop structure, the S connecting structure between every two layers can be in forward and reverse S connection, and the S connecting structure can be in reverse S connection, so that the bracket can not be axially spirally twisted or deviated between two axial spacing units due to the consistent stress direction, and the space occupation ratio of certain positions is overlarge.

Meanwhile, the stent is made of thin-walled tubes, has smaller outer diameter after being pressed and held, and is more convenient to pass through tiny and tortuous blood vessels.

Drawings

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments consistent with the invention and together with the description, serve to explain the principles of the invention.

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

Fig. 1 is a schematic structural view of a pulmonary artery stent for a young child after first expansion according to an embodiment of the present disclosure.

Fig. 2 is an enlarged schematic view of a portion a in fig. 1.

Fig. 3 is a schematic structural view of a pulmonary artery stent for infants after being expanded for the second time according to an embodiment of the present application.

Fig. 4 is an enlarged schematic view of a portion B in fig. 3.

Fig. 5 is a partial structure diagram of a pulmonary artery stent for infants in a deployed state according to an embodiment of the present application.

Fig. 6 is a partial structural schematic view of a pulmonary artery stent in an expanded state according to an embodiment of the present application.

Fig. 7 is a partial schematic structural diagram of a pulmonary artery stent for infants in a deployed state according to an embodiment of the present application.

Description of reference numerals:

10. a support; 11. an end unit section; 12. a middle unit section; 13. a rod is saved; 14. circular arc transition; 16. a connecting rod; 2. a balloon.

Detailed Description

In order to make the objects, technical solutions and advantages of the embodiments of the present application clearer, the technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application, and it is obvious that the described embodiments are some embodiments of the present application, but not all embodiments. 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 application.

In order to solve the aforementioned problems of the balloon dilatation type pulmonary artery stent in the prior art, on the premise that the diameter of a raw material pipe does not need to be changed, the number of the links in each unit section in the stent is controlled between 12 and 30, the connecting rods are configured to be at least arranged in an interval arc transition mode, the stent is designed to be in an open-loop structure, meanwhile, the post-dilatation can be realized due to the open-loop structure, the S connecting structure between every two layers can be in forward and reverse S connection, and the S connecting structure is in reverse S connection, so that the axial spiral torsion or deviation cannot be caused by the fact that the stress directions of the two axial interval units are consistent due to the forward and reverse S connection, and the space occupation ratio of certain positions is too large.

Meanwhile, the stent is made of thin-walled tubes, in a specific embodiment of the application, the thin-walled tubes are selected to have the wall thickness of 0.2-0.4 mm, and the stent prepared by the method has smaller outer diameter after being pressed and held, so that the stent is more convenient to pass through tiny and tortuous blood vessels.

It should be understood that, based on the above technical ideas of the present application, a plurality of technical solutions based on the above technical ideas can be provided by those skilled in the art, and should be considered as falling within the scope of the basic technical ideas of the present application, and thus the protection scope of the present application can be claimed.

Exemplary embodiments of the present application will now be described with reference to the accompanying drawings, in which:

fig. 1 is a schematic structural view of a baby pulmonary artery stent expanded for the first time according to an embodiment of the present disclosure, fig. 2 is an enlarged structural view of a point a in fig. 1, fig. 3 is a schematic structural view of the baby pulmonary artery stent expanded for the second time according to the embodiment of the present disclosure, and fig. 4 is an enlarged structural view of a point B in fig. 3.

As shown in the drawings, the present embodiment of the application provides a pulmonary artery stent for infants, the stent 10 mainly comprises a plurality of net-like unit sections and connecting rods 16, the stent 10 can be provided with end unit sections 11 at two ends, and a plurality of middle unit sections 12 between the two end unit sections 11. Each unit segment comprises a plurality of end-to-end segment rods 13, the plurality of unit segments 13 being collectively looped about the axis of the stent 10. Connecting rod 16 is connected between adjacent unit festival, and the selection of the festival pole 16 quantity in each unit festival is controlled to 12 to 30, and the junction of two festival poles 13 is circular arc transition 14, and connecting rod 16 follows unit festival ring to evenly distributed, sets up to set up the junction that a connecting rod 16 was set up to at least one circular arc transition 14 of interval in this embodiment, and the junction on the adjacent unit festival corresponds with connecting rod 16 corresponding connection.

In the specific example shown in fig. 1, there are 16 joint rods 13 in each unit joint, and a connecting rod 16 is provided at two circular arc transitions 14. As shown in fig. 3 and 4, as the patient grows, the stent of the present embodiment can be expanded twice, for example, from the expansion angle (α angle in fig. 2) between the two segmental rods 13 in fig. 1 and 2 of about 30 degrees to the expansion angle (α angle in fig. 4) of about 90 degrees shown in fig. 3 and 4. Can realize the repeated expansion of the diameter of the bracket, and meets the growth requirement of the infant patient after the bracket is implanted.

In an embodiment, the stent 10 may be made of one of stainless steel, cobalt-based alloy, platinum-iridium alloy, nickel-titanium alloy, or magnesium-based alloy.

It should be understood that the connecting rod 16 may be selected to be an S-shaped, Z-shaped, or Ω -shaped connecting rod, as applicable, according to the embodiments of the present application. On the basis of proper flexibility of the holding bracket, the width of the rod can be increased selectively to ensure that the bracket obtains higher supporting strength and is suitable for the patients with older infants.

In further embodiments of the present application, the number of the wave lengths of the rod segments 13 in the end unit segments 11 and the middle unit segments 12 can be selected from 12 to 30, preferably 18 or 24, and increasing the number of the wave lengths of the rod segments 13 can increase the expanded diameter of the stent 10. The connecting rods 16 are uniformly distributed along the circumference of the unit section, the number of the connecting rods can be 2-15, and the smaller the number of the connecting rods 16 is, the better the flexibility of the support 10 is.

When the number of wave bands of the unit section rods 13 is preferably 24, the number of the connecting rods 16 can be selected to be 6, one connecting rod 16 is arranged at intervals along the circle of the unit section, and the design ensures that the support obtains higher supporting strength on the basis of keeping the support to have proper flexibility, and is suitable for older infant patients.

When the number of wave bands of the unit section rods 13 is preferably 18, the connecting rods 16 are preferably 3, and one connecting rod 16 is arranged along the unit section circle at intervals of two pairs of wave bands of the section rods 13, so that the stent 10 has better flexibility, and meanwhile, the proper radial supporting strength can be maintained, and the stent is suitable for young infant patients.

In the embodiment of the application, the excircle radius of the section rod 13 in the end unit section 11 is selected to be 0.2-0.5 mm, and the width of the section rod 13 in the end unit section is selected to be 0.1-0.3 mm. The outer circle radius of the middle section rod 13 of the middle unit section 12 is selected to be 0.2-0.4 mm, and the rod width range of the middle section rod 13 of the middle unit section 12 can be selected to be 0.1-0.4 mm.

In the embodiment of the present application, the angle, the outer circle radius and the rod width of the section rod 13 of the end unit section 11 may be the same as or different from the section rod 13 of the middle unit section 12. When the same, the stent 10 can obtain a uniform expansion angle at every two nodal rod vertexes when being expanded, so that the stent 10 can obtain a uniform supporting force, and is better suitable for pulmonary arteries with the same diameter at the far end and the near end of a stenosis part. When they are not the same, it is preferable that the angle of the pitch rods 13 of the end unit sections 11 is smaller than the pitch rods 13 of the middle unit sections 12, the outer radius of the outer circle of the pitch rods 13 of the end unit sections 11 is larger than or equal to the pitch rods 13 of the middle unit sections 12, the rod width of the pitch rods 13 of the end unit sections 11 is smaller than the pitch rods 13 of the middle unit sections 12, and the supporting force of the end portions is smaller than that of the middle portions when expanded. The stent is suitable for pulmonary arteries with different diameters at the distal end and the proximal end.

In a specific embodiment, the width of each rod 13 in the support 10 is selected to be 0.2-0.3 mm, preferably 0.25mm. The larger the rod width of the pitch rods 13 of the stent 10, the greater the radial support force of the stent 10. The wall thickness of the stent can be selected to be 0.2-0.4 mm, preferably 0.3mm, the stent 10 can have a smaller outer diameter after being pressed and held, the outer diameter range after being pressed and held is 2.4 mm-4.1 mm, and the minimum outer diameter after being pressed and held is 2.4mm, so that the delivery of the stent in a human body is facilitated, and meanwhile, the surface of the stent 10 is easy to endothelialize more quickly, and the implantation of the stent is facilitated. This provides an unexpected result, especially during stent delivery, which can be significantly increased over the delivery rate of prior stents.

In a specific embodiment, the length of the segment rod 13 of the middle unit segment 12 may be selected to be 2-5 mm. The length of the nodal rods 13 of the end unit nodes 11 may be the same as the nodal rods 13 of the middle unit node 12 or may be smaller than the nodal rods 13 of the middle unit node 12.

When the length of the section bars 13 of the end unit sections 11 is the same as that of the section bars 13 of the middle unit sections 12, the stent can obtain uniform radial support strength after being expanded.

When the length of the section bars 13 of the end unit sections 11 is smaller than that of the section bars 13 of the middle unit sections 12, the radial supporting force provided by the ends of the stent is larger than that of the section bars 13 of the middle unit sections 12 after the stent is expanded, and meanwhile, when the length of the section bars 13 of the end unit sections 11 is smaller than that of the section bars 13 of the middle unit sections 12, the stent can have a smaller contour effect (bell mouth effect), so that the stent can be suitable for being transported in the body of an infant patient.

Fig. 5 is a partial structural diagram of a pulmonary artery stent for children in a deployed state according to an embodiment of the present application, which shows that the left connection point of the connection rod 16 is in the middle of the arc transition 14, and the right connection point of the connection rod 16 is in the middle of the arc transition 14. Fig. 6 is a partial structural diagram of a baby pulmonary artery stent in a deployed state according to an embodiment of the present application, showing a left side connection point of the connection rod 16 starting at an upper side of the arc transition 14, and a right side connection point of the connection rod 16 starting at a lower side of the arc transition 14. Fig. 7 is a partial schematic structural diagram of a pulmonary artery stent for children in a deployed state according to the third embodiment of the present application, showing a left connection point of the connection rod 16 at a lower starting point of the arc transition 14, and a right connection point of the connection rod 16 at an upper starting point of the arc transition 14.

Wherein the starting point of the connecting rod 16 can be located on the arc transition 14 of the pitch rod 13 which forms an arc angle of-80 to 80 degrees with the X axis (parallel to the central axis of the stent 10), and preferably the starting point of the connecting rod 16 can be located on the pitch rod which forms an arc angle of 54 degrees with the X axis. The distance between the center of the S-shaped connecting rod 16 and the center of the section rod along the X axis is 0.3-0.6 mm, preferably 0.5mm, and the distance along the Y axis can be 0.3-0.6 mm, preferably 0.5mm. The connecting rod 16 may start on a circular arc transition 14 of the pitch rod 13 at an arc angle of 0 ° to the X-axis, as illustrated in fig. 5; the connecting rods can also be positioned on the rod-segment arcs which form arc angles of 54 degrees to-54 degrees with the X axis, as shown in figures 6 and 7, the connecting rods 16 in the above various configuration modes can be staggered along the axial direction of the stent 10, so that the stent can be uniformly deformed in the expansion or crimping process.

It is noted that, herein, relational terms such as "first" and "second," and the like, may be used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Also, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Without further limitation, an element defined by the phrase "comprising a … …" does not exclude the presence of additional identical elements in a process, method, article, or apparatus that comprises the element.

The foregoing is merely exemplary of the invention, which can be understood and carried into effect by those skilled in the art. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments without departing from the spirit or scope of the invention. Thus, the present invention is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims (9)

1. A pulmonary artery stent for infants is of a balloon expansion type and comprises a plurality of net-tube-shaped unit sections and connecting rods, wherein the unit sections comprise a plurality of section rods which are connected end to end, and the unit sections are encircled into a ring shape; the connecting rod is connected with the adjacent unit sections and is characterized in that,

the number of the section rods in each unit section is 18-24, and the length of each section rod is 2-5 mm; the connecting positions of the two section rods are in arc transition, the connecting rods are uniformly distributed along the circumferential direction of the unit sections, the connecting position of one connecting rod is arranged at intervals of at least one arc transition, and the connecting positions on the adjacent unit sections are correspondingly connected with the connecting rods; the support is made of a thin-walled tube, and the wall thickness of the thin-walled tube is 0.2-0.4 mm.

2. The pulmonary artery stent of claim 1, wherein said stent comprises two of said connecting rods having different circumferential inclinations.

3. The pulmonary artery stent for young children as claimed in claim 1, wherein said stent comprises two kinds of said connecting rods having different circumferential inclination directions, and said connecting rods having two directions are arranged in a staggered manner in an axial direction of the stent.

4. The pulmonary artery stent of claim 1, wherein the connecting rods are S-shaped, Z-shaped, or omega-shaped connecting rods.

5. The pulmonary artery stent for young children as claimed in claim 1, wherein the radius of the circular arc transition of the end unit section at both ends of the stent is greater than or equal to the radius of the circular arc transition of the middle unit section.

6. The pulmonary artery stent of an infant of claim 5, wherein the connecting rods between the two end unit segments and the middle unit segment have different circumferential inclination directions.

7. The pulmonary artery stent for young children as claimed in claim 5, wherein the length of the single segment in the middle unit section is 2 to 5mm, and the length of the single segment in the end unit section is equal to or less than that of the single segment in the middle unit section.

8. The pulmonary artery stent of claim 5, wherein the stem width of each of the stem segments in the middle unit segment is greater than or equal to the stem width of each of the stem segments in the end unit segments.

9. The pulmonary artery stent of any one of claims 1 to 8, wherein each of said junctions is disposed at the beginning of said circular arc transition, or,

each of the joints is disposed in the middle of the arc transition.

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