CN116491997A - Tissue closing device and preparation method thereof - Google Patents
Tissue closing device and preparation method thereof Download PDFInfo
- Publication number
- CN116491997A CN116491997A CN202310279342.0A CN202310279342A CN116491997A CN 116491997 A CN116491997 A CN 116491997A CN 202310279342 A CN202310279342 A CN 202310279342A CN 116491997 A CN116491997 A CN 116491997A
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- anchoring
- device body
- bodies
- tissue closure
- tissue
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- 238000002360 preparation method Methods 0.000 title claims abstract description 7
- 238000004873 anchoring Methods 0.000 claims abstract description 87
- 238000000034 method Methods 0.000 claims abstract description 10
- 238000005520 cutting process Methods 0.000 claims description 8
- 238000004519 manufacturing process Methods 0.000 claims description 6
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 5
- 238000007493 shaping process Methods 0.000 claims description 4
- 238000003698 laser cutting Methods 0.000 claims description 3
- 239000000853 adhesive Substances 0.000 claims description 2
- 230000001070 adhesive effect Effects 0.000 claims description 2
- 230000008569 process Effects 0.000 abstract description 8
- 238000009826 distribution Methods 0.000 abstract description 6
- 238000002513 implantation Methods 0.000 abstract description 6
- 230000000694 effects Effects 0.000 abstract description 5
- 238000009828 non-uniform distribution Methods 0.000 abstract 1
- 239000000463 material Substances 0.000 description 16
- 230000000052 comparative effect Effects 0.000 description 8
- 238000012986 modification Methods 0.000 description 4
- 230000004048 modification Effects 0.000 description 4
- 238000012360 testing method Methods 0.000 description 4
- 230000009286 beneficial effect Effects 0.000 description 3
- 238000000605 extraction Methods 0.000 description 3
- 238000000465 moulding Methods 0.000 description 3
- 229920002463 poly(p-dioxanone) polymer Polymers 0.000 description 3
- 239000000622 polydioxanone Substances 0.000 description 3
- 230000004075 alteration Effects 0.000 description 2
- 230000015572 biosynthetic process Effects 0.000 description 2
- 230000015556 catabolic process Effects 0.000 description 2
- 238000006731 degradation reaction Methods 0.000 description 2
- 238000002474 experimental method Methods 0.000 description 2
- 230000003301 hydrolyzing effect Effects 0.000 description 2
- 229920001610 polycaprolactone Polymers 0.000 description 2
- 239000004632 polycaprolactone Substances 0.000 description 2
- AEMRFAOFKBGASW-UHFFFAOYSA-N Glycolic acid Polymers OCC(O)=O AEMRFAOFKBGASW-UHFFFAOYSA-N 0.000 description 1
- 235000003417 Plumeria rubra f acutifolia Nutrition 0.000 description 1
- 244000040691 Plumeria rubra f. acutifolia Species 0.000 description 1
- 229920000954 Polyglycolide Polymers 0.000 description 1
- 239000004743 Polypropylene Substances 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 230000002411 adverse Effects 0.000 description 1
- 230000000740 bleeding effect Effects 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 229920001577 copolymer Polymers 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 229920000747 poly(lactic acid) Polymers 0.000 description 1
- -1 polypropylene Polymers 0.000 description 1
- 229920001155 polypropylene Polymers 0.000 description 1
- 238000011084 recovery Methods 0.000 description 1
- 230000008439 repair process Effects 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 238000009864 tensile test Methods 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
- A61B17/06166—Sutures
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00526—Methods of manufacturing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
- A61B17/06166—Sutures
- A61B2017/06176—Sutures with protrusions, e.g. barbs
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Surgery (AREA)
- Heart & Thoracic Surgery (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Surgical Instruments (AREA)
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
Technical Field
The invention relates to the technical field of surgical suturing, in particular to a tissue closing device and a preparation method thereof.
Background
Surgical sutures are medical devices that are necessary for surgery, and are used in a range covering many departments of hospitals and nearly all surgical patients. In the surgical suturing process, a doctor performs knotting in different forms according to the characteristics of a suturing position and a suture line. In order to save the suture time in the operation process, knotting-free sutures, such as strong fishbone lines, cauchy V-LOC lines and the like, appear on the market later. The knotting-free suture performs self-closing on tissues through the sawtooth structure of the suture body, the knotting operation in the traditional suture process is not needed, the time for closing the tissues after the operation is greatly shortened, and meanwhile, the probability of bleeding and related complications is reduced. However, the formation of the saw teeth tends to reduce the strength of the wire itself, which is a relationship between the saw teeth and the wire, and thus the structure of the saw teeth and the strength of the wire have a great influence on the closing effect. The fixing force provided by the uniformly distributed anchoring bodies in the existing knotting-free suture is uniformly distributed in the length direction of the wire, and the fixing force is small, so that closing failure is easy to cause. Partially hydrolyzed broken absorbable materials may exhibit simultaneous degradation of the serrations causing the closure of each serration and simultaneous failure.
Disclosure of Invention
The present invention addresses the above-described shortcomings and drawbacks of the prior art by providing a tissue closure device.
The technical scheme for solving the defects existing in the prior art is as follows: the utility model provides a tissue closure device, includes the device body and locates the anchor body on device body surface to and the part of walking, its characterized in that: the anchoring bodies are distributed in clusters on the surface of the device body, the passing components are connected with the device body, the inclination direction of the anchoring bodies and the passing components are forward, namely, the root direction of the anchoring bodies points to the advancing direction of the passing components.
Preferably, the said through part is connected with the device body, the device body can be connected with the through part at one end, can also be connected with the through part at both ends, the oblique direction of the anchoring body is forward with the through part.
Preferably, the connection mode of the passing component and the device body can be mechanical connection or adhesive connection.
Preferably, the anchoring bodies are distributed in spiral cluster shape on the surface of the device body, each cluster comprises 3-8 anchoring bodies, and the distance between the clusters is 0.2-12mm.
Preferably, the included angle between the anchoring body and the length direction of the device body is 25-65 degrees, and the ratio of the depth of the anchoring body to the diameter of the device body is 0.08-0.48:1, the length of the anchoring body is 0.2-10mm.
The invention also provides a preparation method of the tissue closing device, which comprises the following steps:
selecting a wire rod which is used as a device body;
cutting the anchoring body in a cutting mode;
immersing the device body and the anchoring body in water at 35-55 ℃ for shaping.
The cutting preparation mode can be cutter cutting or laser cutting.
The anchoring body and the device body can also be integrally formed by adopting a die.
The invention has the beneficial effects that:
compared with the prior art, the tissue closing device has the following beneficial effects:
1. the anchoring bodies on the surface of the tissue closing device are distributed unevenly in a cluster manner, so that the anchoring force of the closing device is enhanced, the possibility of closing failure caused by even and small fixing force provided by the evenly distributed anchoring bodies in the traditional knotting-free suture is further reduced, the cluster anchoring bodies on the whole device surface of the tissue closing device can provide larger fixing force, namely, the traditional evenly distributed anchoring points are changed into a plurality of large anchoring points on the device surface, and the stability and effectiveness of the device after anchoring are obviously improved;
2. the clustered anchoring bodies are distributed on the surface of the tissue closing device, so that the possibility that the saw teeth are closed and fail simultaneously due to simultaneous degradation of saw teeth possibly occurring in the absorbable material with partial hydrolytic fracture along with water absorption of the material in the tissue recovery process is reduced, if the clustered anchoring bodies are distributed, the clustered anchoring bodies are distributed so that the clustered anchoring bodies stay between clusters even if the device fails, the situation that the anchoring bodies fail simultaneously is avoided, the resistance between the device and skin can be increased, and the closing safety is improved;
3. the surface anchoring body and the traversing component of the tissue closing device are distributed in the same direction and in the same direction, so that the smoothness in the implantation process of the device is ensured, and the anchoring and fixing effects of the clustered anchoring body are better after the anchoring body is reversely dragged and pulled when a doctor determines the implantation anchoring position.
4. The clustered distribution anchors of the tissue closure device of the present invention may be suitable for absorbable materials, as well as non-absorbable materials; the cluster structure in the technical scheme can ensure that in devices with the same material and the same specification, the anchoring effect of the anchoring body is superior to that of the structure which is evenly distributed, and because of the cluster distribution form, when the material is decomposed and broken, the clusters are broken, a flower-shaped head end is formed, the specific surface area is large, the friction force is large, the skin tissue is basically recovered at the moment, the tissue can still be properly closed by utilizing the residual closing force of the device, and the better repair of the tissue is facilitated.
Drawings
FIG. 1 is a schematic view of the tissue closure device of the present invention in use in connection with a traversing element;
FIG. 2 is a schematic view of the structure of the tissue closure device of the present invention in use with two traversing elements;
FIG. 3 is an enlarged schematic view of a partial structure of a tissue closure device of the present invention comprising a plurality of anchor clusters;
FIG. 4 is a schematic cross-sectional view of a tissue closure device of the present invention.
FIG. 5 is an enlarged schematic view of a partial structure of a tissue closure device of the present invention including an anchor cluster;
FIG. 6 is a schematic view of the angle between the body and the anchor of the tissue closure device of the present invention.
Fig. 7 is a schematic view of the depth and length of the anchoring body of the tissue closure device of the present invention.
Detailed Description
The invention will now be described in further detail with reference to the drawings and examples, which are simplified schematic illustrations of the basic structure of the invention, which are only illustrative.
Fig. 1-7 show a specific scheme of the tissue closing device of the invention, which comprises a device body 1 and an anchoring body 2 arranged on the surface of the device body 1, wherein the anchoring bodies 2 are distributed in clusters on the surface of the device body 1, and the inclined directions of the anchoring bodies 2 are distributed in the same section of body in the same direction. The clustered anchoring bodies on the whole device surface of the tissue closing device can provide larger fixing force, namely, the traditional mode of uniformly distributing anchoring points to a plurality of clustered anchoring points on the device surface is changed, so that the stability and effectiveness of the device after anchoring are remarkably improved. The equidirectional distribution of the anchoring bodies ensures that the forward implantation in the body implantation process is not hindered by the reverse anchoring bodies, and the anchoring and fixing effects of the clustered anchoring bodies are better after the reverse dragging and lifting are carried out when a doctor determines the implantation anchoring position.
The device body 1 in the present invention may be made of an absorbable material or a non-absorbable material. Wherein the absorbable material comprises, but is not limited to, one or more of polylactide, polycaprolactone, polyglycolide, polydioxanone, or a blend or copolymer of two or more materials. The absorbable material can be cohesive type degradable absorbable material or hydrolytic type degradable absorbable material.
Fig. 1 shows a schematic overall view of a tissue closure device with a single piercing member 7, and fig. 2 shows a schematic overall view of a tissue closure device with a piercing member 7 attached at both ends, wherein 1 represents the device body, 2 represents the anchoring body, 7 represents the piercing member, which may be a suture needle.
As shown in fig. 3 and 5, the anchoring bodies 2 in the present invention may be distributed in spiral clusters on the surface of the device body 1, like pagodatree flower, each cluster contains 3-8 anchoring bodies 2, and the interval between the anchoring bodies is 0.2-10mm. Fig. 3 schematically shows the distance between two anchor clusters, the distance between anchor cluster 3 and anchor cluster 4 being L, wherein L has a value of 0.2-12mm.
Fig. 6 shows the relationship between the anchor body 2 and the longitudinal direction of the device body 1, in which fig. 5 shows the center line of the device body 1, 6 shows the center line of the anchor body 2, Φ shows the angle between the center line 5 of the device body 1 and the center line 6 of the anchor body 2, that is, the angle between the longitudinal direction of the device body 1 and the anchor body 2, and experiments show that the angle is better in the range of 25 ° -65 °.
Fig. 7 also shows the relationship between the depth of the anchor body 2 (i.e., the distance the root of the anchor body protrudes into the surface of the device body, calculated perpendicular to the length of the body) and the diameter of the device body 1, where H represents the depth of the anchor body 2 and D represents the diameter of the device body 1. Experiments have shown that the ratio of the depth H of the anchor body 2 to the diameter D of the device body 1 is preferably in the range of 0.08-0.48.
Fig. 6 and 7 also show the length L1 of the anchor, i.e. the root-to-crest distance outside the anchor 2. Tests have shown that the length L1 of the anchoring body 2 is preferably 0.2-10mm.
The invention is further illustrated by the following 3 examples and comparative examples:
example 1: the method is characterized in that polydioxanone absorbable wire with the diameter of USP No. 1 is selected as a device body, the technical scheme of the invention is adopted to manufacture the tissue closing device, each cluster comprises 6 anchoring bodies, the interval between the anchoring bodies in the cluster is 2mm, the interval between the clusters is 5mm, the included angle between the anchoring bodies and the device body is 40 degrees, the diameter of the body is 0.55mm, and the ratio of the depth of the anchoring bodies to the diameter of the body is 0.3:1, i.e. 0.165mm, the anchor length is 2mm. The anchoring body and the device body are cut and molded by props, and are immersed in water at 35 ℃ for shaping for 15 minutes after molding. Comparative example 1: the polydioxanone absorbable wire with the diameter of USP No. 1 is selected as the main body of the device for uniform anchor molding, the density of the anchors is 2.6 per mm, the anchors are evenly distributed along the length direction of the device body, and the depth of the anchors and the diameter of the device body are consistent with those of the embodiment 1.
Example 2: the technical scheme of the invention is adopted to manufacture the tissue closing device, wherein each cluster comprises 8 anchoring bodies, the interval between the anchoring bodies in the cluster is 10mm, the interval between the clusters is 12mm, the included angle between the anchoring bodies and the device body is 65 degrees, the diameter of the device body is 0.55mm, and the ratio of the depth of the anchoring bodies to the diameter of the device body is 0.48:1, i.e. the depth of the anchoring body is 0.264mm and the length of the anchoring body is 10mm. The anchoring body and the device body are formed by laser cutting, and are immersed into water at 55 ℃ for shaping for 10 minutes after being formed.
Comparative example 2: the polycaprolactone absorbable wire with the diameter of USP No. 1 is selected for uniform anchor molding, the density of the anchors is 0.1 per mm, the anchors are evenly distributed in the length direction of the main body of the device, and the depth of the anchors and the diameter of the device body are consistent with those of the embodiment 2.
Example 3: the technical scheme of the invention is adopted to manufacture the tissue closing device, wherein each cluster comprises 3 anchoring bodies, the interval between the anchoring bodies in the cluster is 0.2mm, the interval between the clusters is 0.4mm, the included angle between the anchoring bodies and the tissue closing device body is 25 degrees, the diameter of the body is 0.55mm, and the ratio of the depth of the anchoring bodies to the diameter of the body is 0.08:1, i.e. the depth of the anchor is 0.044mm and the length of the anchor is 0.2mm. The anchoring body and the device body are integrally formed by adopting a die.
Comparative example 3: the uniform anchor formation was performed by selecting polypropylene non-absorbable wire with a diameter of USP No. 1, the anchor density was 5 pieces/mm, the anchors were equally distributed in the longitudinal direction of the apparatus body, and the anchor depth and the apparatus body diameter were the same as those of example 3.
After the anchoring body is formed, a tensile testing machine is adopted to test breaking strength and extraction force of the formed tissue closing device, the gauge length is 50mm, and the stretching rate is 100mm/min.
The test data are respectively:
| example 1 | Comparative example 1 | Example 2 | Comparative example 2 | Example 3 | Comparative example 3 | |
| Extraction 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 |
The test shows that the breaking strength of example 1, example 2 and example 3 is different, and the material is different. The comparison data of the embodiment 1 and the comparison 1, the embodiment 2 and the comparison 2 and the embodiment 3 and the comparison 3 show that the mechanical properties of wires of the same material and the same specification are basically consistent in different technical schemes, the shape of the anchoring body of the invention improves the extraction force of the wires in the using process, the breaking strength of the wires is not adversely affected, the possibility of closing failure of the wires is obviously reduced due to structural change, and the beneficial effects of the technical scheme are reflected.
According to the technical scheme, the probability of closure failure can be reduced, because the anchoring body of the cluster structure enables the contact area of skin tissues and the cluster structure to be far larger than that of the skin tissues and a single anchoring body, the larger the contact area is, the larger the resistance of the same device is, and the resistance of the embodiment 1 is about 3 times that of the comparative embodiment 1, so that the risk of closure failure can be effectively reduced.
In the application of the tissue closure device of the present invention to the suturing of wound tissue, the tissue is self-closing due to the anchor without the need for tying knots during the suturing process. The tissue closure device of the present invention may have a needle attached to one end or may have needles attached to both ends. In the case of connecting the suture needle, the direction of the anchor body is to be in line with the suture needle, i.e. the root of the anchor body points in the direction of travel of the suture needle. If both ends of the tissue closure device are connected to the needle, two segments of the closure device are required, one segment being opposite the anchor of the other.
While preferred embodiments of the present invention have been described, additional variations and modifications in those embodiments may occur to those skilled in the art once they learn of the basic inventive concepts. It is therefore intended that the following claims be interpreted as including the preferred embodiments and all such alterations and modifications as fall within the scope of the invention.
It will be apparent to those skilled in the art that various modifications and variations can be made to the present invention without departing from the spirit or scope of the invention. Thus, it is intended that the present invention also include such modifications and alterations insofar as they come within the scope of the appended claims or the equivalents thereof.
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.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202310279342.0A CN116491997A (en) | 2023-03-21 | 2023-03-21 | Tissue closing device and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202310279342.0A CN116491997A (en) | 2023-03-21 | 2023-03-21 | Tissue closing device and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN116491997A true CN116491997A (en) | 2023-07-28 |
Family
ID=87317376
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202310279342.0A Pending CN116491997A (en) | 2023-03-21 | 2023-03-21 | Tissue closing device and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN116491997A (en) |
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2023
- 2023-03-21 CN CN202310279342.0A patent/CN116491997A/en active Pending
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