Anastomosis nail and processing method of anastomosis nail

Abstract

The invention relates to the technical field of anastomosis nails, and discloses an anastomosis nail and a machining method of the anastomosis nail. The anastomosis nail comprises a nail crown and two nail legs, the two nail legs are arranged at the two ends of the nail crown respectively, the two nail legs and the nail crown are located on the same datum plane, first planes are arranged on the faces, close to each other, of the nail legs, the first planes are perpendicular to the datum plane, second faces are arranged on the two sides of each first plane, and anti-twisting protruding edges are formed between the first planes and the second faces. And the anti-twisting ribs are parallel to the reference surface. The anti-twisting ribs can play a role in restraining bending of the nail legs during nail forming, so that the nail legs are bent into the nail in the datum plane, namely, no nail forming twisting exists, blood leakage and blood oozing are effectively avoided, damage and complications such as local inflammation and edema caused by twisting of surrounding tissues are reduced, and then the risk of infection is reduced; the problem of fracture caused by poor nail forming is also reduced, and the success rate of an operation is improved.

Description

Technical Field

[0001] The present invention relates to the technical field of anastomotic staples, and in particular to an anastomotic staple and a method for processing the anastomotic staple. Background Art

[0002] Since its introduction in 1978, staplers, as a special tool to replace manual suturing by doctors, have now entered various departments in the field of surgery and can handle various complex working conditions and procedures. In gastrointestinal surgery, staplers are widely used for the resection and reconstruction of intestinal, stomach, esophagus and other tissues. By completing the cutting and anastomosis of tissues in one go, staplers greatly shorten the operation time and reduce the risk of bleeding and infection; in thoracic surgery such as lung resection and mediastinal tumor resection, staplers can accurately anastomose lung tissue, bronchi and blood vessels to ensure the surgical effect and postoperative recovery of patients; in gynecological surgery, such as hysterectomy and cervical conization, staplers can be used for suturing the vaginal stump to reduce the risk of postoperative bleeding and infection. In vascular surgery, staplers can be used for vascular reconstruction, bypass and other operations to ensure the patency of blood vessels and blood supply to tissues. Stapler is a medical device mainly used in gastrointestinal surgery to replace traditional manual suturing.

[0003] According to the functional classification, staplers can be divided into tubular staplers and linear staplers. Tubular staplers, also known as circular staplers, are mainly used to create circular or annular anastomoses. This type of stapler is particularly suitable for surgeries that require reconstruction of the continuity of the digestive tract, such as intestinal resection, reconstruction or anastomosis. Tubular staplers can complete the cutting and anastomosis of tissues in one go, ensuring the tightness and stability of the anastomosis. Due to its unique design, tubular staplers can adapt to pipeline structures of different diameters, such as esophagus, stomach, small intestine, large intestine, etc.; linear staplers are mainly used for the creation of straight or oblique anastomoses. This type of stapler is suitable for surgeries that require cutting and anastomosis of longer tissues, such as repair of abdominal wall defects, rectal surgery, gynecological surgery, etc. The linear stapler also has the function of completing cutting and anastomosis in one go, which can significantly reduce the operation time and improve the efficiency of the operation. In addition, the linear stapler can also adjust the size and position of the anastomosis as needed to meet different surgical needs.

[0004] From the perspective of practical application, it can be divided into open staplers and laparoscopic staplers. Open staplers are mainly used in open surgery, which is the traditional surgical method, and the surgical operation is completed by directly exposing the surgical area; laparoscopic staplers are mainly used in minimally invasive surgery, and the surgical operation is completed under the laparoscope by entering the body through a laparoscope or other endoscopic equipment.

[0005] According to the operation mode, it can be divided into manual staplers, electric staplers and the latest surgical robot-assisted stapler system. Manual staplers are traditional surgical instruments that are manually operated by doctors to complete tissue cutting and staplement; electric staplers are surgical instruments driven by electricity, which complete tissue cutting and staplement through mechanical transmission. They are easy to operate and reduce the difficulty of operation for doctors. The high control accuracy reduces surgical errors. In recent years, surgical robot-assisted systems equipped with stapler modules have gradually entered clinical applications. It integrates minimally invasive, intelligent and efficient operations, and has become the direction of future development.

[0006] The stapler, as the most critical component of the stapler, is usually made of titanium alloy or pure titanium. Depending on the type and size of the stapler, each stapler usually contains 20-70 staples. During the operation, the staplers are pushed into the tissue through the release system of the stapler, evenly distributed around the area to be closed, and provide a certain amount of stress to achieve rapid and accurate tissue anastomosis.

[0007] However, if Figure 1 As shown in FIG. 1 , the cross-section of conventional staplers 1 is circular, which is easy to process and has good passability. Figure 2 As shown, it is type "B". However, in actual use, the working conditions are complicated and poor nailing often occurs. Its common forming form is as follows Figure 3 and Figure 4 Clinically, it is often found that the molded morphology is different from Figure 3 and Figure 4 More twisted staples. When staples are twisted, the wound healing process may be disturbed. Twisted staples cannot provide stable support and connection, so the wound cannot heal smoothly. When the anastomotic pressure is insufficient, it will also cause adverse events such as bleeding and bleeding; poor staple molding may lead to local stress concentration, increasing the risk of staple breakage; similarly, the shape of twisted staples is unpredictable, which may cause damage to surrounding tissues including local inflammation and edema. The twisting of staples will also significantly increase the risk of infection. Twisted staples cannot completely close the wound, allowing bacteria and other pathogens to enter the wound and cause infection; for patients, twisted staples may cause discomfort or pain. This seriously affects the patient's daily life and recovery process.

[0008] Therefore, there is an urgent need for a stapler and a method for processing the stapler to solve the above problems. Summary of the invention

[0009] Based on the above, the object of the present invention is to provide a stapler and a method for processing the stapler, which have better planar stability and effectively avoid distortion during the staple forming process.

[0010] To achieve the above object, the present invention adopts the following technical solutions:

[0011] Staples, including:

[0012] nail crown;

[0013] Two nail legs are provided, and the two nail legs are respectively arranged at two ends of the nail crown and are located on the same reference plane as the nail crown. A first plane is provided on a side of the nail legs close to each other, and the first plane is perpendicular to the reference plane. Second surfaces are provided on both sides of the first plane, and an anti-twist ridge is formed between the first plane and the second surface, and the anti-twist ridge is parallel to the reference plane.

[0014] As a preferred solution of the anastomosis staple, the two second surfaces at one side away from the first plane are connected to the third surface, and the anti-twist ridge is also formed between the second surface and the third surface.

[0015] As a preferred solution of the anastomotic staple, the second surface is arranged perpendicular to both the first plane and the third surface.

[0016] As a preferred solution of the stapler, the ratio of the width of the first plane to the width of the second plane is set to 1.15-1.6.

[0017] As a preferred embodiment of the staple, the ratio of the width of the first plane to the width of the second plane of the staple made of titanium or titanium alloy is greater than the ratio of the width of the first plane to the width of the second plane of the staple made of magnesium alloy.

[0018] As a preferred solution for the anastomosis staple, the third surface is arranged parallel to the first plane, and the second surfaces are symmetrically arranged on both sides of the first plane and gradually approach each other from away from the third surface.

[0019] As a preferred embodiment of the anastomotic staple, the staple leg is divided into a first section and a second section which are at an angle β to each other, and the range of β is 150°-180°; the second section is connected to the staple crown, and the transition radius of curvature between the second section and the staple crown is r, and the range of r is 0.1mm-0.5mm; a staple tip is provided at one end of the first section away from the second section, and the staple tip is provided with an angle α, and the range of α is 30°-70°; the height of the staple leg is H, and the range of H is 1.5mm-5.0mm; the height of the first section is h1, and the ratio of h1 to H is 0-0.5; the distance between the staple tips is l1; the length of the staple crown is l2; the ratio of l1 to H is 1-1.5; the ratio of l2 to H is 1.1-1.6.

[0020] As a preferred solution of the anastomotic staple, a rounded corner is provided between the first plane and the second surface.

[0021] A method for processing anastomotic staples, used for processing the anastomotic staples as described in some of the above schemes, the processing method comprising:

[0022] Rolling an ingot of a target material into a plate having a preset thickness;

[0023] cutting the sheet into wires having a preset width;

[0024] cutting the filament into substrates having a predetermined length;

[0025] The substrate is bent to form the staples.

[0026] A method for processing anastomotic staples, used for processing the anastomotic staples as described in some of the above schemes, the processing method comprising:

[0027] Extruding an ingot of the target material into a rod;

[0028] Cold drawing the rod material multiple times to form a circular cross-section wire material;

[0029] Cold drawing the circular cross-section wire material to form a substrate with a preset cross-section;

[0030] Cutting the substrate with a preset cross-section into substrates with a preset length;

[0031] The substrate is bent to form the staples.

[0032] The beneficial effects of the present invention are:

[0033] The present invention provides a nail crown and two nail legs located on the same reference plane, and the first plane of the nail legs is arranged perpendicular to the reference plane, and an anti-twist ridge is formed between the first plane and the second plane. The anti-twist ridge can constrain the bending of the nail legs during nailing, so that the nail legs are bent in the reference plane to form a nail, that is, there is no nailing twisting, which effectively avoids bleeding and bleeding, reduces the damage and complications including local inflammation and edema caused by twisting the surrounding tissue, and thus reduces the risk of infection; it also reduces the problem of fracture caused by poor nailing, and improves the success rate of the operation. At the same time, after nailing, the first plane and the tissue contact part are in surface contact, the anastomosis is more stable and will not generate a large stress on the local tissue, effectively avoiding damage to the local tissue. In addition, compared with the circular cross-section anastomosis staple, the anastomosis staple with the first plane, the second surface and the anti-twist ridge has a larger surface polar inertia moment under the same projection width, so it has a larger bending section coefficient, so it has a greater holding force after nailing, which makes the suture more firm and can adapt to more kinds of low-strength degradable materials. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the following briefly introduces the drawings required for use in the description of the embodiments of the present invention. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on the contents of the embodiments of the present invention and these drawings without paying any creative work.

[0035] Figure 1 is a schematic diagram of anastomotic staples provided in the background art;

[0036] Figure 2 It is a schematic diagram of an ideal staple formation provided by the background art;

[0037] Figure 3 It is a schematic diagram of twisting into nails provided by the background technology;

[0038] Figure 4 It is a top view of a nail twisted as provided in the background art;

[0039] Figure 5 is a schematic diagram of an anastomotic staple provided in a specific embodiment of the present invention;

[0040] Figure 6 is a schematic diagram of the formation of anastomotic staples provided by a specific embodiment of the present invention;

[0041] Figure 7 is a schematic diagram of an anastomotic staple with rectangular staple legs provided in a specific embodiment of the present invention;

[0042] Figure 8 It is a schematic diagram of the processing flow of anastomotic staples with rectangular staple legs provided by a specific embodiment of the present invention;

[0043] Fig. 9 is a front view of an anastomotic staple provided in a specific embodiment of the present invention;

[0044] Fig.10 is a schematic cross-sectional view of a staple leg of an anastomotic staple provided in a specific embodiment of the present invention;

[0045] Fig.11 is a schematic cross-sectional view of a staple leg of an anastomotic staple provided in a specific embodiment of the present invention;

[0046] Fig.12 is a schematic diagram of an anastomotic staple with rectangular staple legs provided in a specific embodiment of the present invention;

[0047] Fig.13 It is a schematic diagram of the processing flow of anastomotic staples provided in a specific embodiment of the present invention.

[0048] In the figure:

[0049] 1. conventional anastomotic staple; 100. anastomotic staple; 110. staple crown; 120. staple leg; 121. first plane; 122. second plane; 123. third plane; 130. anti-twist ridge; 140. first section; 141. staple tip; 150. second section; 160. rounded corner. DETAILED DESCRIPTION

[0050] Embodiments of the present invention are described in detail below, examples of which are shown in the accompanying drawings, wherein the same or similar reference numerals throughout represent the same or similar elements or elements having the same or similar functions. The embodiments described below with reference to the accompanying drawings are exemplary and are intended to be used to explain the present invention, and should not be construed as limiting the present invention.

[0051] In the description of the present invention, it should be noted that the terms "center", "up", "down", "left", "right", "vertical", "horizontal", "inside", "outside" and the like indicate positions or positional relationships based on the positions or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention. In addition, the terms "first" and "second" are used for descriptive purposes only and cannot be understood as indicating or implying relative importance. Among them, the terms "first position" and "second position" are two different positions.

[0052] Unless otherwise clearly specified and limited, the terms "installed", "connected", "connected", and "fixed" should be understood in a broad sense, for example, it can be a fixed connection or a detachable connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0053] In the present invention, unless otherwise clearly specified and limited, a first feature being "above" or "below" a second feature may include that the first and second features are in direct contact, or may include that the first and second features are not in direct contact but are in contact through another feature between them. Moreover, a first feature being "above", "above" and "above" a second feature includes that the first feature is directly above and obliquely above the second feature, or simply indicates that the first feature is higher in level than the second feature. A first feature being "below", "below" and "below" a second feature includes that the first feature is directly below and obliquely below the second feature, or simply indicates that the first feature is lower in level than the second feature.

[0054] The technical solution of the present invention is further described below with reference to the accompanying drawings and through specific implementation methods.

[0055] like Figure 5 and Figure 6 As shown, this embodiment provides a staple, which includes a staple crown 110 and two staple legs 120. The two staple legs 120 are respectively arranged at two ends of the staple crown 110 and are located on the same reference plane as the staple crown 110. A first plane 121 is arranged on a side of the staple legs 120 that are close to each other. The first plane 121 is arranged perpendicular to the reference plane, and second surfaces 122 are arranged on both sides of the first plane 121. An anti-twist rib 130 is formed between the first plane 121 and the second surface 122, and the anti-twist rib 130 is arranged parallel to the reference plane.

[0056] By setting the nail crown 110 and two nail legs 120 located on the same reference plane, and the first plane 121 of the nail leg 120 is perpendicular to the reference plane, and an anti-twist rib 130 is formed between the first plane 121 and the second plane 122, the anti-twist rib 130 can constrain the bending of the nail leg 120 during nailing, so that the nail leg 120 is bent within the reference plane to form a nail, that is, there is no nailing twist, which effectively avoids bleeding and oozing, reduces damage and complications such as local inflammation and edema caused by twisting surrounding tissues, and thus reduces the risk of infection; it also reduces the problem of fracture caused by poor nailing, and improves the success rate of the operation. At the same time, after nailing, the first plane 121 is in surface contact with the tissue contact part, the anastomosis is more stable and will not generate large stress on the local tissue, effectively avoiding damage to the local tissue. In addition, compared with the circular cross-section staple 100, the staple 100 having the first plane 121, the second surface 122 and the anti-twist ridge 130 has a larger polar moment of inertia at the same projected width, and therefore has a larger bending section coefficient, thereby having a greater holding force after being stapled, which not only makes the suture more secure, but also can adapt to a wider range of lower-strength degradable materials.

[0057] Specifically, the two second surfaces 122 are connected to each other at one end away from the first surface, that is, the cross section of the nail leg 120 is triangular. Figure 7 As shown, the two second surfaces 122 are connected to the third surface 123 on one side away from the first plane 121, and anti-twist ridges 130 are formed between the second surface 122 and the third surface 123. That is, the nail leg 120 is in a quadrangular prism shape, and the number of anti-twist ridges 130 is increased, and the anti-twist effect is better.

[0058] Specifically, the second surface 122 is arranged perpendicularly to the first plane 121 and the third surface 123, that is, the cross section of the nail leg 120 is rectangular. It is worth noting that the width of the second surface 122 is a, and the width of the first surface is b. Under the same cross-sectional area S=ab, the larger a is, the larger the moment of inertia of its cross-sectional area. Therefore, the larger the bending section coefficient is, the greater the clamping force after nailing. The larger b is, the smaller the clamping force is, but the nailing is more stable. Therefore, according to the finite element simulation, the nailing process is simulated using display dynamics, and an alternating load perpendicular to the nail leg 120 is added to it, and the ratio of the width of the first plane 121 to the width of the second surface 122 is set to 1.15-1.6, that is, b:a is between 1.15 and 1.6, so that it has both stability and a large clamping force. It is worth noting that the ratio of the width of the first plane 121 to the width of the second surface 122 is related to the material of the nail leg 120. Optionally, the ratio of the width of the first plane 121 to the width of the second plane 122 of the staple 100 made of titanium or titanium alloy is greater than the ratio of the width of the first plane 121 to the width of the second plane 122 of the staple 100 made of magnesium alloy. Exemplarily, when the staple 100 is made of titanium or titanium alloy, b:a is between 1.45 and 1.6. When the staple 100 is made of magnesium alloy, b:a is between 1.15 and 1.2.

[0059] like Figure 8 As shown, this embodiment also discloses a method for processing a staple 100, which is used to process the staple 100 with a rectangular cross section of the staple leg 120 as described in the above scheme, and the processing method includes: rolling an ingot of a target material into a plate with a preset thickness a; cutting the plate into a wire with a preset width b; cutting the wire into a base material with a preset length; and bending the base material to form the staple 100. That is, the wire material with a rectangular cross section is formed by cutting, and then the staple 100 is formed by cutting and bending.

[0060] Optionally, the target material may be titanium and titanium alloys; may be magnesium and magnesium alloys; may be iron and iron alloys; may be zinc and zinc alloys.

[0061] Specifically, Fig. 9As shown, the nail leg 120 is divided into a first section 140 and a second section 150 which are at an angle β to each other, and the range of β is 150°-180°; the second section 150 is connected to the nail crown 110, and the transition curvature radius between the second section 150 and the nail crown 110 is r, and the range of r is 0.1mm-0.5mm; the end of the first section 140 away from the second section 150 is provided with a nail tip 141, and the nail tip 141 is provided with an angle α, and the range of α is 30°-70°; the height of the nail leg 120 is H, and the range of H is 1.5mm-5.0mm; the height of the first section 140 is h1, and the ratio of h1 to H is 0-0.5; the distance between the nail tips 141 is l1; the length of the nail crown 110 is l2; the ratio of l1 to H is 1-1.5; the ratio of l2 to H is 1.1-1.6.

[0062] Preferably, if Fig.10 As shown, a rounded corner 160 is provided between the first plane 121 and the second plane 122. Fig.11 As shown, a rounded corner 160 is also provided between the second surface 122 and the third surface 123 .

[0063] In other embodiments, Fig.12 As shown, the third surface 123 is arranged parallel to the first plane 121, and the second surfaces 122 are symmetrically arranged on both sides of the first plane 121 and gradually approach from away to close to the third surface 123. That is, the cross section of the nail leg 120 is arranged as an isosceles trapezoid.

[0064] like Fig.13 As shown, this embodiment also discloses a processing method of anastomosis staple 100, which is used to process the anastomosis staple 100 as described in any of the above schemes, and the processing method includes: extruding an ingot of a target material into a rod; cold drawing the rod multiple times to form a circular cross-section wire; cold drawing the circular cross-section wire to form a substrate with a preset cross-section; cutting the substrate with a preset cross-section into a substrate with a preset length; bending the substrate to form the anastomosis staple 100. That is, the substrate with a preset cross-section is formed by cold drawing, and the preset cross-section here can be a rectangle or a trapezoid.

[0065] The above contents are only preferred embodiments of the present invention. For ordinary technicians in this field, according to the concept of the present invention, there will be changes in the specific implementation methods and application scopes. The content of this specification should not be understood as limiting the present invention.

Claims

1. Staples, It is characterized in that include: Crown (110); Two nail legs (120) are provided. The two nail legs (120) are respectively provided at two ends of the nail crown (110) and are located on the same reference plane as the nail crown (110). A first plane (121) is provided on a side of the nail legs (120) close to each other. The first plane (121) is perpendicular to the reference plane, and second surfaces (122) are provided on both sides of the first plane (121). An anti-twist rib (130) is formed between the first plane (121) and the second surface (122), and the anti-twist rib (130) is parallel to the reference plane.

2. The stapler according to claim 1, It is characterized in that The two second surfaces (122) are connected to the third surface (123) at one side away from the first plane (121), and the anti-twist ridge (130) is also formed between the second surface (122) and the third surface (123).

3. The stapler according to claim 2, It is characterized in that The second surface (122) is arranged perpendicular to both the first plane (121) and the third surface (123).

4. The stapler according to claim 3, It is characterized in that The ratio of the width of the first plane (121) to the width of the second plane (122) is set to 1.15-1.

6.

5. The stapler according to claim 4, It is characterized in that The ratio of the width of the first plane (121) to the width of the second plane (122) of the titanium and titanium alloy staples is greater than the ratio of the width of the first plane (121) to the width of the second plane (122) of the magnesium alloy staples.

6. The stapler according to claim 2, It is characterized in that The third surface (123) is arranged in parallel with the first plane (121), and the second surfaces (122) are symmetrically arranged on both sides of the first plane (121) and gradually approach each other from a direction away from the third surface (123).

7. The stapler according to any one of claims 1 to 6, It is characterized in that The nail leg (120) is divided into a first section (140) and a second section (150) which are at an angle β to each other, and the range of β is 150°-180°; the second section (150) is connected to the nail crown (110), and the transition curvature radius between the second section (150) and the nail crown (110) is r, and the range of r is 0.1mm-0.5mm; the first section (140) is provided with a nail tip (141) at one end away from the second section (150) ), the nail tip (141) is provided with an angle α, the range of α is 30°-70°; the height of the nail leg (120) is H, the range of H is 1.5mm-5.0mm; the height of the first section (140) is h1, the ratio of h1 to H is 0-0.5; the distance between the nail tips (141) is l1; the length of the nail crown (110) is l2; the ratio of l1 to H is 1-1.5; the ratio of l2 to H is 1.1-1.

6.

8. The stapler according to any one of claims 1 to 6, It is characterized in that A rounded corner (160) is provided between the first plane (121) and the second surface (122).

9. Processing method of staples, It is characterized in that Used for processing the anastomotic staple according to any one of claims 3 to 5, the processing method comprising: Rolling an ingot of a target material into a plate having a preset thickness; cutting the sheet into wires having a preset width; cutting the filament into substrates having a predetermined length; The substrate is bent to form the staples.

10. Processing method of staples, It is characterized in that The stapler according to any one of claims 1 to 9, wherein the processing method comprises: Extruding an ingot of the target material into a rod; Cold drawing the rod material multiple times to form a circular cross-section wire material; Cold drawing the circular cross-section wire material to form a substrate with a preset cross-section; Cutting the substrate with a preset cross-section into substrates with a preset length; The substrate is bent to form the staples.

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