CN1640505A - Sine-wave tubular medical interventional stent - Google Patents

Abstract

The sinusoidal waveform tubular medical interventional stent is used to expand and support narrow blood vessels, esophagus, bile duct, intestinal tract or urethra and other human body lumens. It is etched from metal tubes and has a tubular network structure. It is composed of a plurality of sinusoidal circular basic structures (1) distributed in the same direction, and the distance (12) between two adjacent sinusoidal circular basic structures is 2 to 4 times of its sinusoidal amplitude (7). Long, the crest of the sine wave corresponds to the trough, and is connected by a sine wave connector (2), and the connection point (4) is selected between the crest and the trough of the circular basic structure of the sine wave. The overall width (11) of the sinusoidal wave connector (2) should be less than or equal to half the wavelength (8) of the sinusoidal wave of the sinusoidal circular ring-shaped basic structure, and its rib width (5) should be less than or equal to the sinusoidal circular ring-shaped Rib width of the base structure (3). The bracket has the advantages of adjustable radial support force, good axial flexibility and the like.

Description

Sine wave tubular medical interventional stent

Technical field

The invention relates to a medical sinusoidal waveform tubular medical interventional stent, which is used for expanding and supporting narrowed blood vessels, esophagus, bile duct, intestinal tract or urethra, etc., and belongs to the technical field of medical equipment manufacturing.

Background technique

Vascular embolism, esophageal cancer, benign prostatic hyperplasia and biliary stones are common luminal obstructive diseases in daily life. Open surgery can be used for clinical treatment. Not only is the operation difficult, but there are also some difficult problems to solve, such as many complications, The high risk and high recurrence rate require a more convenient, safe and effective method to solve the above difficulties, and the intervention of internal stents is an effective method. Intraluminal stents are a commonly used device and come in various shapes, with tubular being the most common. Most of the existing internal stents for human cavity are grid-like or spiral filament-like structures, which are used to expand and support narrow blood vessels, esophagus, biliary tract, intestinal tract, urinary catheter and other human body lumens after being implanted in the human body. It relieves cavity obstruction, keeps the cavity unobstructed, is easy to operate, reliable in curative effect, and has few complications. However, there are still some defects in the existing stents. For example, the commonly used non-vascular intraluminal stents are mostly braided with silk, which is in the shape of a tubular grid. Such stents have overlapping points of metal materials, which makes the fluidity of body fluids worse. Moreover, the radial support force of the bracket is insufficient, and the adjustable range is small. Commonly used vascular stents also have disadvantages such as small radial support force of the stent and poor axial bendability. Therefore, there are further requirements for the design and manufacture of medical body intracavity stents that meet the surgical requirements.

Contents of the invention

Technical problem: The purpose of this invention is to change the deficiencies of the currently used medical stents in the human body cavity, and provide a kind of structure with exquisite design, adjustable radial support force, good axial flexibility, low metal coverage, and no metal. The overlapping points of materials, good blood flow performance and other advantages, medical sine wave tubular medical interventional stent with tubular mesh structure.

Technical solution: The medical sinusoidal tubular medical interventional stent of the present invention is etched from a metal tube and has a tubular mesh structure, and is characterized in that the stent in the cavity is composed of a plurality of sinusoidal circular rings distributed along its axial direction. The basic structure is formed, and every adjacent two ring-shaped basic structures with sinusoidal waveforms are connected by sinusoidal waveform connectors.

In the above sinusoidal tubular medical interventional stent, the sinusoidal peak of each sinusoidal annular basic structure corresponds to the sinusoidal trough of its adjacent sinusoidal annular basic structure. The axis direction of the sinusoidal waveform ring-shaped basic structure and the sinusoidal waveform connector is perpendicular to each other, and the connection point between the sinusoidal waveform ring-shaped basic structure and the sinusoidal waveform connector is selected between the crest and the trough of the sinusoidal waveform ring-shaped basic structure .

In the above sinusoidal tubular medical interventional stent, between every two adjacent sinusoidal circular basic structures, the sinusoidal connectors are distributed at equal intervals, and the distance is an integer multiple of the sine wave wavelength of the sinusoidal circular basic structure , the integer is 1 or 2 or 3 etc. The distance between two adjacent ring-shaped basic structures with sinusoidal waves is 2 to 4 times longer than the amplitude of the sinusoidal waves.

In the above sinusoidal tubular medical interventional stent, the overall width of the sinusoidal connector should be less than or equal to half the wavelength of the sinusoidal wave of the sinusoidal ring-shaped basic structure, and the half wavelength of the sinusoidal wave should be less than or equal to two adjacent sinusoidal waves Half of the pitch of the ring-shaped basic structure, the rib width should be less than or equal to the rib width of the sinusoidal ring-shaped basic structure.

When the present invention is used for expansion and support of vascular stenosis, the outer diameter is 1-20mm, the total length is 5-150mm, the wall thickness is 0.02-0.4mm, and the number of sine wave cycles of the sinusoidal ring-shaped basic structure There are 6-36 pieces, the overall width is 0.5-10mm, and the rib width is 0.06-0.6mm. When the present invention is used for the expansion and support of non-vascular stenosis parts in the human body, its outer diameter is 6-25 mm, its total length is 50-140 mm, its wall thickness is 0.1-0.5 mm, and it has a sinusoidal circular ring-shaped basic structure. The number of sine wave periods is 6-30, the overall width is 1.0-10mm, and the rib width is 0.15-0.7mm. The end of the present invention can be made into a trumpet shape, and its inner and outer surfaces can be covered with metal film, oxide film, polymer film or slow-release drug film.

The metal tube of the present invention can be etched with materials such as nickel-titanium alloy, stainless steel, titanium alloy and pure metal tantalum or gold, etc., wherein, the present invention that adopts nickel-titanium alloy tube etching is a self-expanding stent, and adopts stainless steel tube, titanium alloy The present invention etched by tube, tantalum metal tube or gold metal tube is a balloon-expandable stent.

Beneficial effect: Compared with the existing stent in the human cavity, the present invention has many advantages:

(1) The ring-shaped basic structure of the stent and the connecting parts are both sinusoidal waveforms, which are easy to coordinate with each other during deformation, improve the expansion and contraction ratio of the stent before and after deformation, reduce the size of the stent auxiliary installation device, and facilitate the installation of the stent during surgery.

(2) The propagating direction of the sinusoidal fluctuations of the sinusoidal wave connector of the bracket and the sinusoidal ring-shaped basic structure are perpendicular to each other. When the bracket is subjected to an axial load, the elastic recovery of the sinusoidal wave connector itself can effectively prevent the ring-shaped basic structure of the bracket Structures squeeze into each other.

(3) By changing the sine wave amplitude of the sine wave ring-shaped basic structure of the bracket, the distance between two adjacent sine wave ring-shaped basic structures, and changing the sine wave ring-shaped basic structure distributed along the axial direction of the stent number, so that the radial support force of the stent can be adjusted to obtain a stent with an ideal radial support force;

(4) The connectors of the stent are designed to be sinusoidal, so the stent has good axial flexibility, which not only facilitates placement in curved and complex lumens, but also reduces the stimulation of the lumen intima;

(5) The metal coverage of the stent is low, the surface is smooth, the structure is continuous, easy to polish, and can overcome thrombus and calculus.

(6) No overlapping points of metal materials, small frictional resistance, good blood flow performance, especially suitable for biliary tract and blood vessels.

Description of drawings

Fig. 1 is a schematic diagram of the deployment of the stent according to Example 1 of the present invention.

Fig. 2 is a schematic diagram of the deployment of the stent of Example 2 of the present invention.

Fig. 3 is a schematic diagram of a radial cross-sectional structure of the present invention.

The reference signs are: 1—sinusoidal circular basic structure, 2—sinusoidal connector, 3—rib width of sinusoidal circular basic structure 1, 4—connection point, 5—E sinusoidal connector 2 rib width, 6—the amplitude of the sine wave of the sine wave connector 2, 7—the amplitude of the sine wave of the E sinusoidal circular ring-shaped basic structure 1, 8—the amplitude of the sine wave of the E sine wave circular ring-shaped basic structure 1 Wavelength, 9—the overall width of the sine wave ring-shaped basic structure 1, 10—the half wavelength of the sine wave of the sine wave connector 2, 11—the overall width of the sine wave connector 2, 12—two adjacent sine wave circles The distance between the annular basic structures [1], 13—the distance, 14—the outer diameter of the bracket, 15—the wall thickness of the bracket, and 16—the total length of the bracket.

Specific implementation plan

Below, the present invention will be further described in conjunction with the accompanying drawings and embodiments.

Example 1

Referring to Fig. 1, the sinusoidal waveform tubular medical interventional stent is etched from a superelastic nickel-titanium alloy tube and has a tubular network structure, consisting of a plurality of sinusoidal waveform circular ring-shaped basic structures 1 distributed along its axial direction, each Two adjacent sinusoidal circular ring-shaped basic structures 1 are connected by a sinusoidal connector 2 . The sine wave crest of each sine wave circular basic structure corresponds to the sine wave trough of its adjacent sine wave circular basic structure. The propagating directions of the sinusoidal fluctuations of the sinusoidal ring-shaped basic structure 1 and the sinusoidal connector 2 are perpendicular to each other. The connection point 4 between the sinusoidal ring-shaped basic structure 1 and the sinusoidal-wave connector 2 is selected at the middle position between the crest and the trough of the sinusoidal ring-shaped basic structure 1 . Between every two adjacent sinusoidal circular ring-shaped basic structures 1 , the sinusoidal wave connectors 2 are distributed at equal intervals, and the distance 13 is twice the sine wave wavelength 8 of the sinusoidal circular ring-shaped basic structures 1 . The distance 12 between two adjacent sinusoidal ring-shaped basic structures 1 is 2.5 times as long as the amplitude 7 of the sinusoidal wave. The overall width 11 of the sinusoidal wave connector 2 is less than half of the sine wave wavelength 8 of the sinusoidal wave ring-shaped basic structure 1, and the half-wavelength 10 of the sine wave is equal to the distance 12 between two adjacent sinusoidal wave ring-shaped basic structures 1 Half, its rib width 5 is less than the rib width 3 of the sinusoidal circular ring-shaped basic structure 1 .

The outer diameter 14 of the stent in this embodiment is 2.45mm, the total length 16 is 19.771mm, the wall thickness 15 is 0.1mm, and the expanded width is 7.694mm. The overall width 9 is 1.771mm, the rib width 3 is 0.12mm, the amplitude 7 of the sinusoidal wave of the sinusoidal circular ring-shaped basic structure 1 is 0.885mm, and its wavelength 8 is 1.282mm. The spacing 12 between the structures 1 is 2 mm, the overall width 11 of the sinusoidal wave connector 2 is 0.588 mm, the rib width 5 is 0.1 mm, the amplitude 6 of the sine wave is 0.294 mm, and the half wavelength 10 is 1 mm, adjacent The distance 13 between two sinusoidal-wave connectors 2 is 2.565 mm.

This embodiment is a self-expanding vascular stent. During the operation, the present invention is constrained in the catheter. After being implanted into the stenotic part of the blood vessel, the constraining catheter is removed. The present invention expands by itself due to its good superelasticity, and plays a role in the treatment of stenotic blood vessels. Expansion and support function to achieve the purpose of treatment.

The end of the bracket in the cavity can also be made into a trumpet shape. The inner and outer surfaces of the stent in the cavity can also be covered with metal film, oxide film, polymer film or slow-release drug film. The material of the metal tube for etching the stent in the lumen can also be stainless steel, or titanium alloy, or pure metal tantalum or gold.

Example 2

See Figure 2. The sinusoidal waveform tubular medical interventional stent is etched from a superelastic nickel-titanium alloy tube. It has a tubular network structure and consists of multiple sinusoidal circular ring-shaped basic structures [1] distributed along its axial direction. , between every two adjacent sinusoidal circular ring-shaped basic structures [1], connected by sinusoidal connectors [2]. Between every two adjacent sinusoidal circular ring-shaped basic structures [1], the sinusoidal waveform connectors [2] are distributed at equal intervals, and the distance [13] is 1.282 mm, which is a sinusoidal circular ring-shaped basic structure [1] 1 times longer than the wavelength of the sine wave [8]. Other structures and dimensions of the stent in Embodiment 2 are the same as those in Embodiment 1.

Claims (10)

1, a kind of sine-wave tubular medical interventional stent, form by the metal tube etching, network structure in a tubular form, it is characterized in that this intracanal scaffold is made of circular basic structure of a plurality of sinusoidal wave forms (1) and sinusoidal wave form connector (2) along its axial distribution, between every adjacent two circular basic structures of sinusoidal wave form (1), connect by sinusoidal wave form connector (2), the sinusoidal wave trough of the circular basic structure of sinusoidal wave form (1) that the sinusoidal wave crest of the circular basic structure of each sinusoidal wave form (1) is adjacent is corresponding, the axis of the circular basic structure of described sinusoidal wave form (1) is vertical mutually with the axis direction of sinusoidal wave form connector (2), and the point of contact (4) of circular basic structure of sinusoidal wave form (1) and sinusoidal wave form connector (2) is selected between the crest and trough of the circular basic structure of described sinusoidal wave form (1).

2, sine-wave tubular medical interventional stent according to claim 1 is characterized in that the circular basic structure of described sinusoidal wave form (1) and the point of contact (4) of sinusoidal wave form connector (2) are selected in the crest and the trough centre position of the circular basic structure of described sinusoidal wave form (1).

3, sine-wave tubular medical interventional stent according to claim 1, it is characterized in that between every adjacent two circular basic structures of sinusoidal wave form (1), sinusoidal wave form connector (2) is equidistant distribution, and this spacing (13) is the integral multiple of the sinusoidal wave wavelength (8) of the circular basic structure of sinusoidal wave form (1).

4, sine-wave tubular medical interventional stent according to claim 1 is characterized in that the spacing (12) between adjacent two circular basic structures of sinusoidal wave form (1) is 2～4 double-lengths of its sinusoidal wave amplitude (7).

5, sine-wave tubular medical interventional stent according to claim 1, the integral width (11) that it is characterized in that sinusoidal wave form connector (2) is less than or equal to half of wavelength (8) of the sine wave of the circular basic structure of sinusoidal wave form (1), its sinusoidal wave half-wavelength (10) is less than or equal to half of spacing (12) of adjacent two circular basic structures of sinusoidal wave form (1), and its muscle width (5) is less than or equal to the muscle width (3) of the circular basic structure of sinusoidal wave form (1).

6, sine-wave tubular medical interventional stent according to claim 1, when it is characterized in that this intracanal scaffold is used for the expansion at angiostenosis position and supporting role, its external diameter (14) is 1～20mm, length overall (16) is 5～150mm, wall thickness (15) is 0.02～0.4mm, the number of the sine wave period of the circular basic structure of sinusoidal wave form (1) is 6～36, and its integral width (9) is 0.5～10mm, and its muscle width (3) is 0.06～0.6mm.

7, sine-wave tubular medical interventional stent according to claim 1, when it is characterized in that this intracanal scaffold is used for the expansion of non-blood vessel tract narrow positions in the human body and supporting role, its external diameter (14) is 6～25mm, length overall (16) is 50～140mm, wall thickness (15) is 0.1～0.5mm, the number of the sine wave period of the circular basic structure of sinusoidal wave form (1) is 6～30, and its integral width (9) is 1.0～10mm, and its muscle width (3) is 0.15～0.7mm.

8, sine-wave tubular medical interventional stent according to claim 1 is characterized in that this intracanal scaffold end makes broadening formation.

9, sine-wave tubular medical interventional stent according to claim 1 is characterized in that this intracanal scaffold surfaces externally and internally covers metal film, oxidation film, polymeric membrane or slow releasing pharmaceutical film.

10, sine-wave tubular medical interventional stent according to claim 1, the material that it is characterized in that the metal tube of this intracanal scaffold of etching are Nitinol or rustless steel or titanium alloy or simple metal tantalum or gold.

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