CN116491997A - A tissue closure device and its preparation method - Google Patents

Abstract

The invention relates to the technical field of suturing, and provides a tissue closing device and a preparation method thereof. The clustered distribution is in a non-uniform distribution form, and the distribution mode can increase the closing force of the closing device on the basis of guaranteeing breaking strength, so that the safety is improved. The equidirectional distribution of the anchoring bodies ensures that the closing device is not blocked by the reverse anchoring bodies in the implantation process, and the anchoring closing effect of the clustered anchoring bodies is better.

Description

A tissue closure device and its preparation method

technical field

The invention relates to the technical field of surgical suturing, in particular to a tissue closure device and a preparation method thereof.

Background technique

Surgical suture is a necessary medical equipment for surgery, and its use covers many departments of the hospital and almost all surgical patients. During the surgical suturing process, doctors perform different forms of knotting according to the suture site and the characteristics of the suture thread. Later, in order to save suturing time during the operation, knot-free sutures appeared on the market, such as Johnson & Johnson's herringbone suture and Kehui's V-LOC suture. Knot-free suture self-closes the tissue through the sawtooth structure of the thread body itself, without the need for knotting operations in the traditional suture process, which greatly shortens the time for tissue closure after surgery, and at the same time reduces the risk of bleeding and related complications probability. However, the formation of sawtooth will inevitably reduce the strength of the wire itself, and the two are in a trade-off relationship, so the structure of the sawtooth and the strength of the wire will have a great impact on the closing effect. In the existing knot-free suture, the fixing force provided by the evenly distributed anchors is evenly distributed along the length of the wire, and the fixing force is small, which may easily cause closure failure. Absorbable materials that are partially hydrolyzed and fractured may degrade the serrations at the same time, causing each serration to close and fail simultaneously.

Contents of the invention

The present invention provides a tissue closure device to solve the above-mentioned defects and deficiencies of the prior art.

The technical solution of the present invention to solve the defects in the prior art is to provide a tissue closure device, which includes a device body, an anchor body arranged on the surface of the device body, and a passing component, and is characterized in that: the anchor body is placed on the surface of the device body The surface of the device body is distributed in clusters, the traveling part is connected with the device body, and the inclination direction of the anchor body is in the same direction as the traveling part, that is, the direction of the root of the anchoring body points to the traveling direction of the traveling part.

Preferably, the passing part is connected to the device body, the device body can be connected to the passing part at one end, or both ends can be connected to the passing part, and the inclination direction of the anchor body is in the same direction as the passing part.

Preferably, the connection between the traveling part and the device body may be a mechanical connection or an adhesive connection.

Preferably, the anchors are distributed in spiral clusters on the surface of the device body, each cluster contains 3-8 anchors, and the distance between clusters is 0.2-12mm.

Preferably, the angle between the anchor body and the length direction of the device body is 25°-65°, the ratio of the depth of the anchor body to the diameter of the device body is 0.08-0.48:1, and the length of the anchor body is 0.2-10mm.

The present invention also provides a method for preparing a tissue closure device, comprising the following steps:

Select the wire used as the device body;

Cut out the anchor body by cutting;

Immerse the device body together with the anchor body in water at 35-55°C to set the shape.

The cutting preparation method may be knife cutting or laser cutting.

The anchor body and the device body can also be integrally formed by using a mold.

Beneficial effects of the present invention:

Compared with the prior art, the tissue closure device of the present invention has the following beneficial effects:

1. The anchors on the surface of the tissue closure device of the present invention are clustered and non-uniformly distributed, which enhances the anchoring force of the closure device, and the fixation force provided by the uniformly distributed anchors in the traditional knot-free suture is both average and relatively low. The possibility of closure failure caused by small size is further reduced, and the cluster anchors on the entire device surface of the tissue closure device of the present invention can provide greater fixing force, that is, the traditional evenly distributed anchor points are changed to the anchor points on the device surface. The method of several large anchor points significantly improves the stability and effectiveness of the device after anchoring;

2. The cluster-like distribution of anchors on the surface of the tissue closure device of the present invention reduces the possibility of simultaneous degradation of the serrations that may occur in the partially hydrolyzed absorbable material as the material absorbs water during the tissue recovery process, resulting in the simultaneous failure of each serration closure. Possibility, if the device with clustered anchor distribution breaks, it will inevitably break between clusters. The distribution of cluster anchors makes the device stay between clusters even if it fails, and will not When the anchors fail at the same time, this can increase the resistance between the device and the skin and improve the safety of closure;

3. The anchoring body on the surface of the tissue closure device of the present invention and the passing parts are distributed in the same direction and forward direction, which ensures the smoothness of the device implantation process, and after the doctor confirms the anchoring position for implantation, after dragging and pulling in the opposite direction, The anchoring effect of clustered anchors is better.

4. The cluster-distributed anchors of the tissue closure device of the present invention can be applied to absorbable materials, and can also be applied to non-absorbable materials; The anchoring effect of the fixed body is better than that of the evenly distributed structure, and because of its cluster distribution form, when the material is decomposed and fractured, a flower-shaped head will be formed when the material is decomposed and fractured, and the specific surface area is large. For the line segment with high friction force, the skin tissue is basically restored at this time, and the residual closing force of the device can still be used to properly close the tissue and help the tissue to repair better.

Description of drawings

Fig. 1 is a schematic structural view of the tissue closure device of the present invention when connected to a passing component;

Fig. 2 is a schematic structural view of the tissue closure device of the present invention when connected to two passing components;

Fig. 3 is an enlarged schematic diagram of the partial structure of the tissue closure device of the present invention comprising multiple anchor clusters;

Fig. 4 is a schematic cross-sectional view of the tissue closure device of the present invention.

Fig. 5 is an enlarged schematic diagram of the partial structure of the tissue closure device of the present invention comprising an anchor cluster;

Fig. 6 is a schematic diagram of the angle between the device body and the anchor body of the tissue closure device of the present invention.

Fig. 7 is a schematic diagram of the depth and length of the anchor body of the tissue closure device of the present invention.

Detailed ways

The present invention will be further described in detail below in conjunction with the accompanying drawings and embodiments. These drawings are all simplified schematic diagrams, and only illustrate the basic structure of the present invention in a schematic manner.

Fig. 1-7 shows the specific scheme of the tissue closure device of the present invention, comprising a device body 1 and an anchor body 2 arranged on the surface of the device body 1, the anchor body 2 is distributed in clusters on the surface of the device body 1, and the anchor The inclination directions of the fixed body 2 are distributed in the same direction on the same section of the main body. The cluster distribution is a form of non-uniform distribution, which enhances the anchoring force of the closure device, and brings less fixation force and evenly distributed anchoring body in the traditional knot-free suture. The possibility of closure failure is further reduced, and the clustered anchors on the entire device surface of the tissue closure device of the present invention can provide greater fixing force, that is, the traditional evenly distributed anchor points are changed to several clusters of anchor points on the device surface In this way, the stability and effectiveness of the device after anchoring are significantly improved. The distribution of the anchors in the same direction ensures that the antegrade implantation during body implantation is not hindered by the reverse anchors, and when the doctor determines the anchoring position for implantation, the clustered anchors will The anchoring effect of fixed body is better.

The device body 1 in the present invention can be made of absorbable material or non-absorbable material. The absorbable material includes but not limited to polylactide, polycaprolactone, polyglycolide, polydioxanone, or a blend or copolymer of two or more materials. The absorbable material can be a cohesively degradable absorbable material, or a hydrolytically degradable absorbable material.

Figure 1 shows the overall schematic diagram of a tissue closure device with a single passing component 7, and Figure 2 shows the overall schematic diagram of a tissue closure device with both ends of the passing component 7 connected, where 1 represents the device body, 2 represents the anchor body, and 7 represents the The threading part may be a suture needle.

As shown in Figure 3 and Figure 5, the anchoring bodies 2 in the present invention can be distributed in spiral clusters on the surface of the device body 1, like Sophora japonica, each cluster contains 3-8 anchoring bodies 2, anchoring The distance between the body and the anchor body is 0.2-10mm. Fig. 3 schematically shows the distance between two anchor clusters, the distance between the anchor cluster 3 and the anchor cluster 4 is L, wherein the value of L is 0.2-12 mm.

Figure 6 shows the angle relationship between the anchoring body 2 and the longitudinal direction of the device body 1, in which 5 represents the centerline of the device body 1, 6 represents the centerline of the anchoring body 2, and Φ represents the centerline of the device body 1 5 and the centerline 6 of the anchoring body 2, that is, the angle between the length direction of the device body 1 and the anchoring body 2, tests have shown that the effect is better when the angle is 25°-65° good.

Figure 7 also shows the relationship between the depth of the anchor body 2 (i.e. the distance that the root of the anchor body extends into the surface of the device body, calculated perpendicular to the length direction of the body) and the diameter of the device body 1, where H represents the anchor The depth of the fixed body 2, D represents the diameter of the device body 1, and the test shows that the ratio of the depth H of the anchor body 2 to the diameter D of the device body 1 is 0.08-0.48, and the effect is better.

6 and 7 also show the length L1 of the anchor body, that is, the distance from the outer root of the anchor body 2 to the top. Tests have shown that the length L1 of the anchoring body 2 is more suitable to be 0.2-10mm.

Below by 3 embodiments and comparative example the present invention is further illustrated:

Example 1: The polydioxanone absorbable wire with a diameter of USP No. 1 is selected as the device body, and the technical solution of the present invention is used to make a tissue closure device. Each cluster contains 6 anchors, and the clusters are anchored The distance between the body and the anchor body is 2mm, the distance between clusters is 5mm, the angle between the anchor body and the device body is 40°, the diameter of the body is 0.55mm, and the ratio of the depth of the anchor body to the diameter of the body is 0.3:1 , namely 0.165mm, the length of the anchor body is 2mm. The anchor body and the device body are cut and shaped by props, and then immersed in water at 35°C for 15 minutes to set the shape. Comparative example 1: A polydioxanone absorbable wire with a diameter of USP No. 1 was selected as the main body of the device to form a uniform anchor body. Distribution, the depth of the anchor body and the diameter of the device body are consistent with Example 1.

Example 2: The polycaprolactone absorbable wire with a diameter of USP No. 1 is selected as the device body, and the technical solution of the present invention is used to make a tissue closure device. Each cluster contains 8 anchors, and the anchors and anchors in the cluster form The distance between the anchors is 10mm, the distance between clusters is 12mm, the angle between the anchor and the device body is 65°, the diameter of the body is 0.55mm, and the ratio of the depth of the anchor to the diameter of the device is 0.48:1, that is The depth of the anchor body is 0.264mm, and the length of the anchor body is 10mm. The anchor body and the device body are shaped by laser cutting, and then immersed in water at 55°C for 10 minutes to set the shape.

Comparative example 2: The polycaprolactone absorbable wire with a diameter of USP 1 was used to form a uniform anchor body. The density of the anchor body was 0.1 pieces/mm. Body depth and device body diameter are consistent with Example 2.

Example 3: A polypropylene non-absorbable wire with a diameter of USP No. 1 is selected as the device body, and the technical solution of the present invention is used to make a tissue closure device. Each cluster contains 3 anchors, and the anchors and anchors in the cluster The distance between clusters is 0.2mm, the distance between clusters is 0.4mm, the angle between the anchor body and the body of the tissue closure device is 25°, the diameter of the body is 0.55mm, and the ratio of the depth of the anchor body to the diameter of the body is 0.08: 1. That is, the depth of the anchor body is 0.044mm, and the length of the anchor body is 0.2mm. The anchor body and the device body are integrally formed by a mold.

Comparative example 3: The polypropylene non-absorbable wire with a diameter of USP 1 was selected to form a uniform anchor body. The anchor body density was 5 pieces/mm, and the anchor bodies were evenly distributed in the length direction of the device body. The anchor body depth and The diameter of the device body is consistent with that of Example 3.

After the anchor body was formed, the tensile testing machine was used to test the breaking strength and pull-out force of the formed tissue closure device. The gauge length was 50 mm, and the tensile rate was 100 mm/min.

The test data are:

Example 1 Comparative example 1 Example 2 Comparative example 2 Example 3 Comparative example 3 Pull out force/N 16.8 5.6 8.7 7.3 7.6 5.9 Breaking strength/N 59.4 59.3 83.8 83.8 98.5 98.5

After testing, it is found that the different breaking strengths of Example 1, Example 2 and Example 3 are the result of different materials. The comparative data of embodiment 1 and comparative example 1, embodiment 2 and comparative example 2, embodiment 3 and comparative example 3 show that the same material and the wire rod of the same specification are basically consistent in terms of mechanical properties in different technical solutions. The shape of the anchoring body improves the pull-out force of the wire during use, and has no adverse effect on the breaking strength of the wire, and the structural change makes the possibility of its closure failure significantly reduced, reflecting the beneficial effect of this technical solution .

This technical solution can reduce the probability of closure failure, because the anchor body of the cluster structure makes the contact area between the skin tissue and the cluster structure much larger than the contact area between the skin tissue and a single anchor body, the larger the contact area, the same device The greater the pull-out resistance, the resistance of Example 1 is about three times that of Comparative Example 1, so this technical solution can effectively reduce the risk of closure failure.

When the tissue closure device of the present invention is applied to the suture of wound tissue, the tissue can be self-closed due to the anchor body, and there is no need to tie a knot during the suture process. A suture needle can be connected to one end of the tissue closure device of the present invention, or both ends can be connected to the suture needle. In the case of connecting a suture needle, the direction of the anchor body should be in the same direction as the suture needle, that is, the root of the anchor body points to the advancing direction of the suture needle. If both ends of the tissue closure device are connected with suture needles, it needs to be a two-section closure device, and the direction of the anchor body of one section is opposite to that of the other section.

While preferred embodiments of the invention have been described, additional changes and modifications to these embodiments can be made by those skilled in the art once the basic inventive concept is appreciated. Therefore, it is intended that the appended claims be construed to cover the preferred embodiment as well as all changes and modifications which fall within the scope of the invention.

Obviously, those skilled in the art can make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalent technologies, the present invention also intends to include these modifications and variations.

Claims (8)

1. A tissue closure device comprising a device body (1), an anchoring body (2) arranged on the surface of the device body (1) and a traversing part (7), and is characterized in that: the anchoring bodies (2) are distributed in clusters on the surface of the device body (1), the passing components (7) are connected with the device body (1), the inclination direction of the anchoring bodies (2) and the passing components (7) are forward, namely, the root direction of the anchoring bodies (2) points to the advancing direction of the passing components (7).

2. The tissue closure device of claim 1, wherein: the device body (1) can be connected with the passing component (7) at one end or can be connected with the passing component (7) at both ends of the device body (1).

3. The tissue closure device of any one of claims 1-2, wherein: the connection mode of the passing component (7) and the device body (1) can be mechanical connection or adhesive connection.

4. The tissue closure device of any one of claims 1-2, wherein: the anchoring bodies (2) are distributed in spiral clusters on the surface of the device body (1), each cluster comprises 3-8 anchoring bodies (2), and the distance between the clusters is 0.2-12mm.

5. The tissue closure device of claim 4, wherein: the included angle between the anchoring body (2) and the length direction of the device body (1) is 25-65 degrees, and the ratio of the depth of the anchoring body (2) to the diameter of the device body (1) is 0.08-0.48:1, the length of the anchoring body (2) is 0.2-10mm.

6. A method of making the tissue closure device of any one of claims 1-5, wherein: the method comprises the following steps:

selecting a wire rod which is used as the device body (1);

cutting the anchoring body (2) in a cutting mode;

immersing the device body (1) and the anchoring body (2) into water at the temperature of 35-55 ℃ for shaping.

7. The method of manufacturing according to claim 6, wherein: the cutting preparation mode can be cutter cutting or laser cutting.

8. A method of making the tissue closure device of any one of claims 1-5, wherein: the anchoring body (2) and the device body (1) are integrally formed by adopting a die.