Anastomotic reinforcement patch and stapler

Abstract

The present disclosure provides an anastomotic reinforcement patch and an anastomotic device, the anastomotic reinforcement patch comprising: a backing, the backing having a first end and a second end in opposite directions in the length direction, the backing having a first surface and a second surface facing away from each other in the thickness direction; a patch, arranged on the first surface, the patch being detachably connected to the backing; a suture, at least a portion of which is sutured to the patch and the backing, so that the patch is detachably connected to the backing, wherein the backing is an elastic material, the elastic material enables the backing to have different constant elongation in the width direction and the length direction of the backing; the constant elongation of the backing in the width direction is greater than or equal to 110% and less than or equal to 145%; preferably 120%, 130% or 140%. The backing of the anastomotic reinforcement patch provided by the present disclosure is elastic in the width direction, so that it can be adapted to anastomotic device components of different circumference sizes.

Description

Technical Field

[0001] The present disclosure relates to the technical field of medical devices, and in particular to an anastomotic reinforcement patch and an anastomotic device. Background Art

[0002] The application of staplers has greatly promoted the development of modern surgery and minimally invasive surgery, and has milestone significance. Staplers can staple tissues through staples while cutting, and are widely used for cutting, suturing or anastomosis of organ tissues such as the intestines, stomach, lungs, and pancreas. However, the rigid stapling of staples alone cannot completely avoid leakage and bleeding of anastomotic tissues. This is because staples are rigid structures that cannot fully match the flexibility of soft tissues, resulting in leakage and bleeding in the staple holes. In addition, due to differences in soft tissue properties in different regions, some soft tissues, such as lungs, have lower strength and may be at risk of anastomotic tearing. To solve the above problems, the anastomotic reinforcement patch can be used in conjunction with the stapler, so that while the stapler cuts and closes the wound, the reinforcement patch is fixed to the wound, blocking the staple holes and improving the strength of the wound, thereby avoiding leakage and bleeding in the wound.

[0003] However, due to the different models of staplers, when staplers of different models and sizes are used in the same operation, different types of reinforcement patches that are compatible with the stapler models need to be replaced, which is not conducive to the progress of the operation. Summary of the invention

[0004] The purpose of the present disclosure is to provide a stoma reinforcement patch and a stapler to solve the technical problems in the related art. The specific solution is as follows:

[0005] A first aspect of an embodiment of the present disclosure provides an anastomotic reinforcement patch, comprising: a backing, the backing having a first end and a second end in opposite directions in a length direction, the backing having a first surface and a second surface facing away from each other in a thickness direction; a patch, arranged on the first surface, the patch being detachably connected to the backing; a suture, at least a portion of the suture being sutured to the patch and the backing, so that the patch is detachably connected to the backing, wherein the backing is an elastic material, the elastic material makes the backing have different constant elongation in the width direction and the length direction of the backing; the constant elongation of the backing in the width direction is greater than or equal to 110%.

[0006] In some embodiments, the elongation at break of the backing in the length direction is less than the elongation at break of the backing in the width direction.

[0007] In some embodiments, the backing has a constant elongation in the length direction of less than or equal to 50%.

[0008] In some embodiments, the maximum force strength of the backing in the width direction and / or the length direction is not less than 220N.

[0009] In some embodiments, the backing has a fixed force recovery rate greater than or equal to 80%.

[0010] In some embodiments, the anastomotic reinforcement patch further includes an end cap, which is disposed at the first end of the backing and is used to accommodate an end of a stapler.

[0011] In some embodiments, the end cap is fixedly connected to the backing, wherein the elongation at fixed force of the end cap is less than or equal to 50%.

[0012] In some embodiments, the minimum distance between the suture lines of the anastomotic reinforcement patch is 6 to 21 mm.

[0013] The second aspect of the present disclosure provides a stapler, comprising: the anastomotic reinforcement patch provided by the first aspect of the present disclosure; a stapler seat assembly, configured to be detachably connected to the anastomotic reinforcement patch; and / or a staple magazine assembly, detachably connected to the anastomotic reinforcement patch and configured to cooperate with the stapler seat assembly to staple the anastomotic reinforcement patch to tissue.

[0014] Compared with the related art, the above solution of the embodiment of the present disclosure has at least the following beneficial effects:

[0015] The backing of the anastomotic reinforcement patch provided in the present invention is elastic in the width direction. When the stapler is extended between the patch and the backing, the backing expands in the width direction under the action of the propulsion force of the stapler due to the elasticity of the backing, thereby being able to adapt to stapler assemblies of different circumference sizes.

[0016] It is to be understood that the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the present disclosure. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] The drawings herein are incorporated into the specification and constitute a part of the specification, showing embodiments consistent with the present disclosure, and together with the specification, are used to explain the principles of the present disclosure. Obviously, the drawings described below are only some embodiments of the present disclosure, and for ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work. In the drawings:

[0018] Figure 1 It is a structural schematic diagram of an anastomotic reinforcement patch according to the related technology.

[0019] Figure 2It is a schematic structural diagram of an anastomotic reinforcement patch with an open-hole structure according to an exemplary embodiment.

[0020] Figure 3 It is a schematic structural diagram of the first surface of an anastomotic reinforcement patch having an open-hole structure and two traction segments with free ends connected according to an exemplary embodiment.

[0021] Figure 4 It is a schematic structural diagram of the second surface of an anastomotic reinforcement patch having an open-hole structure and two traction segments with free ends connected according to an exemplary embodiment.

[0022] Figure 5 It is a schematic structural diagram of the first surface of an anastomotic reinforcement patch with a side slot structure according to an exemplary embodiment.

[0023] Figure 6 It is a schematic structural diagram of the second surface of an anastomotic reinforcement patch with a side slot structure according to an exemplary embodiment.

[0024] Figure 7 It is a schematic structural diagram of the first surface of an anastomotic reinforcement patch with an open-hole groove structure according to an exemplary embodiment.

[0025] Figure 8 It is a schematic structural diagram of a stapler according to an exemplary embodiment.

[0026] Fig. 9 It is a partially enlarged view of a stapler according to an exemplary embodiment.

[0027] Reference numerals:

[0028] Backing 100', patch 200', suture 300';

[0029] Backing 100, opening 101, side slot 102, opening slot 103, first end 110, end cap 111, second end 120;

[0030] A patch 200, a knife guide groove 201, a suture thread 300, a suture section 310, a traction section 320, and a free end 321; an anastomotic reinforcement patch 1000;

[0031] Stapler 2000 , anvil assembly 2100 , and staple cartridge assembly 2200 . DETAILED DESCRIPTION

[0032] In order to make the purpose, technical solutions and advantages of the present disclosure clearer, the present disclosure will be further described in detail below in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present disclosure, rather than all of the embodiments. Based on the embodiments in the present disclosure, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present disclosure.

[0033] The terms used in the embodiments of the present disclosure are only for the purpose of describing specific embodiments, and are not intended to limit the present disclosure. The singular forms "a", "said" and "the" used in the embodiments of the present disclosure and the appended claims are also intended to include plural forms, unless the context clearly indicates other meanings, and "multiple" generally includes at least two, and other quantifiers are similar.

[0034] It should be understood that although the terms first, second, third, etc. may be used to describe ... in the embodiments of the present disclosure, these ... should not be limited to these terms. These terms are only used to distinguish .... For example, without departing from the scope of the embodiments of the present disclosure, the first ... may also be referred to as the second ..., and similarly, the second ... may also be referred to as the first .... In addition, the terms "first", "second", "third", etc. are only used for descriptive purposes and cannot be understood as indicating or implying relative importance.

[0035] It should be understood that the term "and / or" used in this article is only a description of the association relationship of associated objects, indicating that three relationships may exist. For example, A and / or B can represent: A exists alone, A and B exist at the same time, and B exists alone. In addition, the character " / " in this article generally indicates that the associated objects before and after are in an "or" relationship. The singular forms "a", "the" and "the" are also intended to include the plural forms, unless the context clearly indicates other meanings.

[0036] It should be further understood that the terms "center", "longitudinal", "lateral", "front", "back", "up", "down", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", etc., indicating the orientation or position relationship are based on the orientation or position relationship shown in the accompanying drawings, and are only for the convenience of describing the present embodiment and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be understood as a limitation on the present invention.

[0037] In the description of the present disclosure, it should be noted that, unless otherwise clearly specified and limited, the terms "connected" and "connection" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral 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. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0038] As used herein, the words "if" and "if" may be interpreted as "at the time of" or "when" or "in response to determining" or "in response to detecting", depending on the context. Similarly, the phrases "if it is determined" or "if (stated condition or event) is detected" may be interpreted as "when it is determined" or "in response to determining" or "when detecting (stated condition or event)" or "in response to detecting (stated condition or event)", depending on the context.

[0039] It should also be noted that the term "includes", "comprising" or any other variation thereof is intended to cover non-exclusive inclusion, so that a commodity or device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such commodity or device. In the absence of more restrictions, the elements defined by the sentence "comprising a ..." do not exclude the existence of other identical elements in the commodity or device including the elements.

[0040] In related technologies, such as Figure 1 As shown, the anastomotic reinforcement patch includes: a backing 100', a patch 200' and two sutures 300'. The two sutures 300' connect the backing 100' and the patch 200' together, so that the backing 100' and the patch 200' become a whole, and the two sutures 300' have a longer traction section. When in use, the patch 200' is installed on the stapler, and then the stapler is inserted into the body through the puncture device to reach the lesion. The stapler jaws are closed so that the jaws clamp the tissue to be anastomosed. Then the traction section is pulled to completely separate the patch 200' from the backing 100'. Since the suture 300' and the backing 100' have a fixed connection point at the front end, the backing 100' is pulled back by the suture 300'. Next, the stapler is fired to cut tissue and form an anastomosis; the stapler fixes the patch 200' to the anastomosis while forming the anastomosis and cuts it into two parts. Then, the stapler jaws are loosened, and the stapler is withdrawn from the patient's body, and the traction section is continuously pulled out to remove the backing 100'. Thus, the operation is completed, and the purpose of the patch 200' reinforcing the anastomosis is achieved.

[0041] However, since the backing 100' is made of inelastic or low-elastic material, it can be tightly attached to a specific type of stapler. However, with the increase in the number of stapler manufacturers on the market, the sizes of staplers are diverse, especially the circumference values ​​of the stapler magazine and the anvil of the stapler magazine assembly vary, which puts forward new requirements for the anastomotic reinforcement patch. When the circumference of the stapler magazine and the anvil increases, for the inelastic or low-elastic backing material, when the anastomotic reinforcement patch is mounted on the stapler, the increase in the circumference of the stapler magazine and the anvil will cause the increase in the tension of the existing suture 300'; especially when entering the puncture, in addition to the tension on the suture caused by the lateral stretching of the backing, the rolling tendency caused by the friction between the puncture and the backing will also generate additional tension on the suture, which may cause the risk of premature separation of the patch 200' and the backing 100', affecting the surgical process. That is, the anastomotic reinforcement patch provided by the prior art can only support the use of staplers of a specific size, and there is a risk of mismatch for staplers of different models. When using staplers of different models and sizes in the same operation, it is necessary to replace different types of anastomotic reinforcement patches that are compatible with the stapler model, which is not conducive to the progress of the operation. Although this problem can be solved by increasing the elasticity of the backing, there are still risks in increasing the elasticity excessively. This is because the stapler magazine end of the stapler must pass through the puncture device to enter the body cavity. The highly elastic backing causes it to be overstretched when entering the puncture device, and the elastic recovery force of the backing is small, which may cause the patch to shift. This displacement will make the patch unable to completely cover the nail hole, thereby losing the function of reinforcing the anastomosis. In addition, this excessive stretching will also cause the product to twist in the puncture device, which will also make it impossible to effectively perform the operation. Therefore, the backing material must be selected in combination with the changes in the circumference of the stapler sample and the stapler magazine. The test results of the circumference data of different stapler samples are shown in Tables 1 and 2:

[0042] Table 1: List of parameters for assembly of the cutting knife in the component-type laparoscopic stapler cartridge assembly

[0043] ;

[0044] Table 2: Parameters of the cutting knife assembly on the body of the laparoscopic stapler

[0045]

[0046] It can be seen that the circumference of the stapler holder varies from 22.9 to 24.4 mm in the component type laparoscopic stapler stapler assembly, and the variation rate is 106.6% based on the minimum value; while the circumference of the stapler holder varies from 32.3 to 38.4 mm, and the variation rate is 118.9% based on the minimum value. For the stapler holder assembly of the body type laparoscopic stapler, the circumference of the stapler holder is 21.6 mm, and the circumference of the stapler holder is 36.2 to 37.2 mm, and the variation rate is 102.8% based on the minimum value.

[0047] In view of this, optional embodiments of the present disclosure are described in detail below with reference to the accompanying drawings.

[0048] The present disclosure provides an anastomotic reinforcement patch 1000, comprising: a backing 100, a patch 200 and a suture 300, wherein at least a portion of the suture 300 is sutured to the patch 200 and the backing 100, so that the patch 200 and the backing 100 are detachably connected.

[0049] According to the analysis of relevant technical data, the minimum distance between the suture lines of the anastomotic reinforcement patch 1000 is 6-21 mm, preferably 7 mm, 8 mm 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, 16 mm, 17 mm, 18 mm, 19 mm or 20 mm.

[0050] like Figure 2 As shown, the backing 100 has a first end 110 and a second end 120 in opposite directions in the length direction, and an end cap 111 is provided on the first end 110, and the end cap 111 has at least a single-sided opening toward the second end 120, and the end cap 111 is used to accommodate the end of the stapler 2000 so that the end of the stapler 2000 abuts against the end cap 111 and is wrapped in the end cap 111, thereby preventing the end of the stapler 2000 from directly contacting human tissue and preventing the patch 200 from rolling up when the stapler 2000 enters the puncture device.

[0051] Preferably, the end cap 111 is detachably connected to the backing 100, and a portion of the suture 300 is used as a means of fixing the end cap 111 to the backing 100. When the free end of the suture 300 is pulled, after the patch 200 is separated from the backing 100, the suture connection structure between the end cap 111 and the backing 100 is disassembled, releasing the end of the stapler 2000. The suture 300 is detachably sutured at the end cap 111, and the suture method can be the same as the suture method at the patch 200.

[0052] In some embodiments, the end cap 111 is fixedly connected to the backing 100. When the free end of the suture 300 is pulled, the suture 300 is separated from the patch 200. The backing 100 and the end cap 111 are fixed sutures. In response to the free end of the suture 300 being continuously pulled after the patch 200 is separated from the backing 100, the end cap 111 and the backing 100 remain in a fixed connection state. In this state, the end cap 111 has the function of protecting the end of the stapler 2000 to prevent the end of the stapler 2000 from contacting human tissue.

[0053] In some embodiments, a limiting structure for the suture 300 may be provided on the second end 120 of the backing 100, and the limiting structure includes an opening 101 and / or a slot. For example, the slot may be a side slot 102, and at least a portion of the suture 300 passes through the opening 101 and / or the side slot 102 to prevent the suture 300 from being entangled with the stapler 2000 or the anastomotic reinforcement patch 1000, causing the patch 200 to be separated from the backing 100 in advance or difficult to be separated, and failing to complete normal repair.

[0054] In some embodiments, the backing 100 has a first surface and a second surface that are opposite to each other in the thickness direction. The patch 200 is disposed on the first surface, wherein the patch 200 is located between the end cap 111 and the suture line limiting structure, and the patch 200 is detachably connected to the backing 100.

[0055] It should be noted that, for the laparoscopic stapler 2000, the use of the anastomotic reinforcement patch 1000 with the end cap 111 helps the stapler 2000 with the patch 200 to smoothly pass through the puncture instrument into the body cavity. For the linear stapler 2000 for open surgery, the anastomotic reinforcement patch 1000 without the end cap 111 can also be used. This is because for open surgery, the operating space is large and does not pass through the puncture instrument, the risk of rolling up of the anastomotic reinforcement patch 1000 is low, and the anastomotic reinforcement patch 1000 without the end cap 111 can be used.

[0056] When the anastomotic reinforcement patch 1000 is sleeved on the stapler 2000, the stapler 2000 with the patch 200 is inserted into the human body cavity, and the patch 200 is used to repair the anastomosis to protect fragile tissue from being torn, thereby reinforcing the anastomosis and reducing the risks of anastomotic bleeding, air leakage, exudation, etc.

[0057] In some embodiments, the backing 100 is made of an elastic material. Specifically, the elastic performance of the backing 100 in the width direction is tested by a sample with reference to the test method in the test standard 8.3.1 of FZ / T 01034-2008. The sample is 200 mm long and 50 mm wide; the stretching speed is 100 mm / min, the constant force value is 25 N, and the gauge is 100 mm. The test data obtained by the test are as follows: the constant force elongation of the elastic material of the backing 100 in the width direction is greater than or equal to 110% and less than or equal to 145%, preferably 120%, 130% or 140%; the constant force elongation of the backing 100 in the length direction is less than or equal to 50 %, less than or equal to 45% or less than or equal to 40%, that is, under the action of a constant force of 25N, in the width direction of the backing 100, the constant force elongation of the elastic material is at least 110%; in the length direction of the backing 100, the constant force elongation of the elastic material is at most 50%. It can be seen that the elasticity of the elastic material in the length direction of the backing 100 is much smaller than the elasticity of the backing 100 in the width direction, that is, the elastic properties of the elastic material are anisotropic, and there are obvious differences in the orthogonal directions. By selecting a material with relatively high elasticity in the width direction, it can be ensured that the anastomotic reinforcement patch 1000 can be tightly fixed to the nail magazine and the nail seat, and when the circumference of the nail magazine and the nail seat changes, it can still be ensured to be tightly fixed. Selecting a material with relatively low elasticity in the length direction ensures that the patch will not be significantly deformed even if it is rubbed by the puncture. Thereby ensuring that the product will not be over-extended and twisted when passing through the puncture.

[0058] The sample test was carried out with reference to the GB / T 3923.1-2013 test standard. The sample was 200 mm long, 50 mm wide, and had a gauge of 100 mm. The stretching speed was 100 mm / min. The test data were as follows: the breaking strength of the backing 100 in the width direction and the breaking strength of the backing 100 in the length direction were both greater than 220 N, that is, the maximum force strength of the backing 100 in the width direction and / or the length direction was not less than 220 N; the elongation at break of the backing 100 in the width direction was ≥100%; and the elongation at break of the backing 100 in the length direction was ≥140%.

[0059] In summary, the elongation at constant force of the backing 100 in the width direction is greater than or equal to 110%, less than or equal to 145%, preferably 120%, 130% or 140%; the elongation at constant force of the backing 100 in the length direction is less than or equal to 50%, less than or equal to 45% or less than or equal to 40%. If the backing 100 is subjected to a tensile force exceeding 220N, the backing 100 may be at risk of breaking. When the backing 100 is pulled to the breaking limit, the elongation of the backing 100 in the width direction is approximately 140%; the elongation of the backing 100 in the length direction is approximately 100%.

[0060] It should be separately explained that the experimental data obtained in the present disclosure are obtained through multiple tests, and sampling inspection standards are checked in a large amount of experimental data. The data measured by sampling inspection are processed and analyzed by quality tools. The quality compliance is judged by analyzing the data to achieve the purpose of identification and backing 100 quality improvement.

[0061] In some embodiments, when the stapler 2000 extends between the patch 200 and the backing 100, due to the elasticity of the backing 100, the backing 100 expands toward the width direction under the action of the propulsion force of the stapler 2000, so that at least part of the stapler 2000 can be accommodated between the backing 100 and the patch 200. At the same time, due to the elasticity of the backing 100 in the width direction, the backing 100 can fix the patch 200 on the surface of the stapler 2000. In addition, after the suture is pulled, due to the elasticity of the backing 100 in the width direction, the backing 100 can be quickly separated from the patch 200 under the action of the restoring force, and the fixed force recovery rate of the backing 100 is greater than or equal to 80%, greater than or equal to 90%, or greater than or equal to 95%. Therefore, in practical applications, the anastomotic reinforcement patch 1000 provided by the present disclosure has the advantages of simple structure, efficient operation, and higher clinical safety factor.

[0062] On the other hand, since the backing 100 is elastic, when the stapler 2000 is assembled on the anastomotic reinforcement patch 1000, under the action of the stapler 2000, the backing 100 expands toward the width direction, thereby enabling the stapler 2000 assembly to be adapted to different circumference sizes.

[0063] In some embodiments, the backing 100 has slight elasticity in the length direction, and the positional relationship between the end cap 111 and the patch 200 can be adjusted by the slight elasticity of the backing 100 in the length direction. Specifically, when at least a portion of the end cap 111 is covered by the patch 200, the elasticity of the backing 100 in the length direction can be utilized to stretch the backing 100 in the length direction so as to reset the end cap 111 and cover the patch 200 with at least a portion of the end cap 111, thereby ensuring that the stapler 2000 can be accurately inserted into the end cap 111 after being inserted between the backing 100 and the patch 200, wherein the elasticity of the backing 100 in the length direction is much smaller than the elasticity of the backing 100 in the width direction. If the elasticity of the backing 100 in the length direction is greater than or equal to the elasticity of the backing 100 in the width direction, during the installation of the stapler 2000, the patch 200 as a whole may be stretched along the length direction of the backing 100, causing the patch 200 to be offset or misplaced, and may also cause the patch 200 to detach from the end cap 111, exposing the stapler 2000.

[0064] In some embodiments, the end cap and the backing can be made of the same material, and the end cap and the backing can be made integrally, or the end cap and the backing can be made independently and then connected.

[0065] In other embodiments, the end cap 111 is fixedly connected to the backing 100, wherein the material of the end cap 111 has a constant elongation of less than or equal to 50%, less than or equal to 45%, less than or equal to 40%, less than or equal to 35%, less than or equal to 30%, or less than or equal to 25%. The constant elongation of the end cap 111 is the same in the width direction and the length direction of the backing.

[0066] In other embodiments, the backing is inelastic in the length direction. Since the backing 100 has greater elasticity in the width direction, if the backing 100 also has elasticity in the length direction, it may affect the stability of the connection between the patch 200 and the backing 100.

[0067] In some embodiments, the backing 100 is made of 60%-90% nylon and 10%-40% spandex. Nylon is a nylon high elastic fabric with the advantages of high strength, good elasticity and good wear resistance. Spandex is a blended fabric. Nylon and spandex are added to increase the elasticity of the fabric. Since the advantage of spandex itself is its high resilience, blending it with nylon can achieve wrinkle-proof and excellent shaping effect. In the selection and production of the backing 100, the elasticity of the backing 100 in the width direction is ensured. Preferably, the backing 100 is made of 75% nylon and 25% spandex, wherein the tolerance of each component material is ±3%. The backing 100 supported by this ratio can achieve an elasticity in the width direction that is significantly greater than the elasticity of the backing in the length direction, and has good elastic properties and force strength.

[0068] In some embodiments, if the end cap 111 is elastic, the backing 100 as a whole may be stretched along with the end cap 111 due to the pulling of the edge of the end cap 111, which may cause the positioning deviation of the patch 200, especially when the stapler 2000 enters and exits the puncture device. Since the stapler 2000 needs to overcome greater resistance when entering and exiting the puncture device, the position deviation of the patch 200 caused by the pulling of the backing 100 is more prominent. Therefore, the end cap 111 is not elastic.

[0069] In some embodiments, the suture line 300 includes a suture section 310 and a traction section 320, at least a portion of the suture section 310 is used to sew the patch 200 and the backing 100, so that the patch 200 and the backing 100 are detachably connected. The traction section 320 extends from the suture section 310 toward the second end 120 and penetrates the opening 101 and / or the side slot 102. Pulling the free end 321 of the traction section 320 under the action of an external force can separate at least a portion of the suture section 310 from the patch 200 and the backing 100, and further, separate the backing 100 from the patch 200.

[0070] Specifically, a patch 200 is disposed on the first surface of the backing 100, and the suturing section 310 sews the patch 200 and the backing 100 in a detachable manner, so that the patch 200 and the backing 100 are detachably connected. An end cap 111 is disposed at the first end 110 of the backing 100 for receiving the end of the stapler 2000. Preferably, at least a portion of the patch 200 can be received.

[0071] Preferably, one end of the suture 300 is sutured to the backing in a non-detachable manner, so that after the suture segment 310 is removed, it is still connected to the backing 100, so as to pull the backing 100 from the body cavity to the outside of the body. Preferably, if the suture 300 is completely separated from the backing 100, the backing 100 can be taken out of the body by other medical instruments, such as medical forceps or clips.

[0072] Preferably, at least a portion of the suture segment 310 is connected to the end cap 111, and at least a portion of the patch 200 extends into the end cap 111 to guide the stapler 2000 into the end cap 111. The suture segment 310 of the suture line 300 enables the end cap 111 to be detachably disposed on the backing 100. When the suture line 300 is disassembled, the suture connection between the end cap 111 and the backing 100 can be loosened, thereby releasing the end of the stapler 2000 that is sleeved.

[0073] Furthermore, the traction section 320 extends from the suture section 310 toward the second end 120 and passes through the opening 101 and / or the side slot 102. When the traction section 320 is pulled under the action of an external force, the suture section 310 can be separated from the backing 100, thereby separating the patch 200 from the backing 100.

[0074] It can be understood that, since the suture line 300 connecting the backing 100, the patch 200 and the end cap 111 is the same suture line 300, according to the description of the above embodiment, by pulling the free end 321 of the traction segment 320 under the action of external force, the suture segment 310 can be separated from the backing 100, and further, the backing 100 can be separated from the patch 200 and the end cap 111.

[0075] In some embodiments, the patch 200 and the backing 100 have a first state and a second state.

[0076] Specifically, when the patch 200 and the backing 100 are in the first state, the patch 200 is connected to at least a portion of the backing 100 , and at this time, the anastomotic reinforcement patch 1000 is sleeved on the stapler 2000 or at least a portion wraps the stapler 2000 .

[0077] When the patch 200 and the backing 100 are in the second state, the patch 200 and the backing 100 are separated from each other, the anastomotic reinforcement patch 1000 is repaired to the patient's affected area, and the backing 100 and the stapler 2000 can be pulled out of the patient's body.

[0078] When the patch 200 and the backing 100 are in the first state, an external force pulls the free end 321 of the traction section 320 to convert the connection state between the patch 200 and the backing 100 from the first state to the second state.

[0079] In some embodiments, the grooves include: side grooves 102 and / or longitudinal grooves.

[0080] The side groove 102 is arranged at the second end 120 of the backing 100, and the length extension direction of the side groove 102 is parallel to or obliquely intersecting with the width direction of the backing 100; the longitudinal groove is arranged at the second end 120 of the backing 100, and the length extension direction of the longitudinal groove is the same as the length direction of the backing 100.

[0081] In some embodiments, the free end 321 of the traction segment 320 extends outward from the first surface of the backing 100 and passes through the opening 101 and / or the side slot 102 .

[0082] like Figure 2 As shown, an opening 101 is provided on the second end 120 of the backing 100, and the free end 321 of the traction section 320 extends toward the edge of the second end 120 after passing through the opening 101. The setting of the opening 101 limits the freedom of movement of the suture 300 to a certain extent, thereby preventing the suture 300 from being entangled with the stapler 2000 or the anastomotic reinforcement patch 1000, causing the patch 200 to be separated from the backing 100 in advance or difficult to be separated, and failing to complete normal repair.

[0083] In practical applications, a doctor may apply a pulling force to the free end 321 of the traction section 320 , thereby converting the connection state between the patch 200 and the backing 100 from the first state to the second state.

[0084] In some embodiments, Figure 3As shown, two groups of sutures 300 are arranged on the patch 200, and the free ends 321 of the two pulling segments 320 of the two groups of sutures 300 are exposed from the first surface of the backing 100, and the two free ends 321 extend to the two sides of the backing 100 to the second surface of the backing 100, and the second surface is penetrated by the opening 101. The setting of the opening 101 limits the freedom of movement of the sutures 300 to a certain extent, and in this embodiment, the free ends 321 of the pulling segments 320 can be left on the second surface of the backing 100, and when the sutures 300 are separated from the backing 100 and the patch 100, the sutures 300 can be prevented from being entangled with the stapler 2000 or the anastomotic reinforcement patch 1000, causing the patch 200 to be separated from the backing 100 in advance or difficult to be separated, and unable to complete normal repair.

[0085] In some embodiments, the suture 300 includes at least two sutures 300 , and the free ends 321 of the pulling segments 320 of the at least two sutures 300 are connected to each other.

[0086] like Figure 3 , Figure 4 As shown, the free ends 321 of the pulling sections 320 of the two sutures 300 are connected, and the connection method can be a knot fixation or any other connection method that can connect the two sutures 300. The two knots after connection have the same force tendency, and pulling any one of the knots can convert the backing 100 and the patch 200 from the first state to the second state.

[0087] It should be noted that when the two interconnected sutures 300 are pulled, the pulling forces on the two sutures 300 are substantially the same. This is because when the traction segments 320 are pulled, the traction segments 320 on both sides are pulled at the same time but are subjected to force separately. Since the lengths of the traction segments 320 located at the inner and outer arcs are different, the disassembly speeds are also different, which easily causes uneven force on both sides of the patch. However, through the two interconnected sutures 300, the traction segments 320 on both sides can be subjected to force at the same time, and although the traction segments 320 on both sides of the patch 200 have different disassembly speeds, the traction segment 320 on the side that is disassembled faster can compensate for the traction segment 320 on the side that is disassembled slower, so that the two traction segments 320 are pulled at the same time and are subjected to force evenly. Therefore, when the sutures 300 are pulled, the stability of the connection between the patch 200 and the anastomosis can be guaranteed, and the accurate positioning of the patch 200 on the stapler 2000 is prevented from being affected by uneven force on the suture removal.

[0088] In some embodiments, the backing 100 is provided with side slots 102, such as Figure 5As shown, the length extension direction of the side slot 102 is parallel to the width direction of the backing 100, and the length of the side slot 102 is greater than 0.25 times the width of the backing 100; less than 0.5 times the width of the backing 100. The width of the side slot 102 is greater than the width of the traction line; less than 1.5 times the width of the traction line. The free end 321 of the traction segment 320 can pass through the side slot 102 to limit the position of the traction segment 320, so that the free end 321 of the traction segment 320 is exposed from the second surface of the backing 100, so as to prevent the free end 321 of the traction segment 320 from being entangled with the anastomotic reinforcement patch 1000 when the suture 300 is separated from the backing 100, causing the suture 300 to be separated from the backing 100 in advance or unable to be separated.

[0089] Figure 5 , Figure 6 As shown, the free end of the traction segment 320 passes through the side slot 102 from the first surface of the backing 100 and extends to the second surface of the backing 100, and the free end 321 of the traction segment 320 extends toward the edge of the second end 120 on the second surface.

[0090] In practical applications, by pulling the free end 321 of the traction section 320 under the action of an external force, the suture section 310 can be separated from the backing 100 , so that the patch 200 is separated from the backing 100 .

[0091] It should be noted that the present disclosure does not limit the winding method of the free end 321 of the traction section 320. Figure 2 , Figure 5 As shown, the free end 321 of the traction section 320 can extend from the first side of the backing 100 through the opening 101 and / or the side slot 102 to the second side of the backing 100 and then extend toward the second end 120 away from the edge of the first end 110 .

[0092] like Figure 3 , Figure 4 As shown, the free end 321 of the traction section 320 can also be wound from the first surface of the backing 100 to the second surface of the backing 100, and the opening 101 is pierced from the second surface, and the free end 321 extends from the first surface to the second end 120 of the backing 100.

[0093] Any of the above winding methods can pull the free end 321 of the traction section 320 under the action of external force to separate the suture section 310 from the backing 100 .

[0094] In some embodiments, the second end 120 is provided with an opening slot 103, such as Figure 7As shown, an opening slot 103 may also be provided on the second end 120 , and the opening direction of the opening slot 103 extends from the opening 101 to the edge of the second end 120 away from the first end 110 .

[0095] Specifically, the free end 321 of the traction segment 320 is exposed from the first surface and extends toward the edge of the second end 120. Furthermore, the operator can drag the free end 321 of the traction segment 320 to snap the traction segment 320 into the perforated groove 103. The free end 321 of the traction segment 320 snapped into the perforated groove 103 is exposed from the second surface of the backing 100.

[0096] The setting of the opening slot 103 makes it unnecessary for the free end 321 of the traction segment 320 to precisely pass through the opening slot 101, but only needs to slide into the opening slot 103 along the slot gap of the opening slot 103 to complete the position limitation of the traction segment 320. In actual applications, the assembly process of the traction segment 320 and the opening slot 103 takes less time and is easy to operate, which can save surgical time.

[0097] In some embodiments, the patch 200 is provided with a knife guide groove 201. The knife guide groove 201 extends along the length direction of the patch 200, and is substantially strip-shaped, and its orthographic projection on a plane parallel to the horizontal plane is substantially rectangular, but not limited thereto. In other examples, the orthographic projection may also be a chamfered rectangle or other polygonal shapes. The above is only described as an optional example and cannot be understood as a limitation of the present invention.

[0098] The knife guide groove 201 is used in conjunction with the cutting assembly of the stapler 2000 , and the knife guide groove 201 limits the cutting position of the cutting assembly when cutting the tissue to be processed.

[0099] Specifically, after the patch 200 contacts the anastomosis, the cutting assembly inside the stapler 2000 can cut the patch 200 into two parts along the extension direction of the knife guide groove 201. The setting of the knife guide groove 201 can ensure that the cutting assembly completely cuts off the patch 200, and at the same time can ensure that the patch 200 is completely matched with the anastomosis without the use of additional cutting tools, thereby achieving operational convenience in actual applications.

[0100] The openings and / or slots provided on the backing 100 of the anastomotic reinforcement patch 1000 actually form a suture limiting structure, which is used to limit the position of the traction segment 320 of the suture 300 on the backing 100 and affect the direction of the traction segment 320, so as to avoid the problem of the suture 300 being accidentally wound as much as possible. The suture limiting structure may include an opening 101 and / or a slot; further, the slot includes a side slot 102 and / or a longitudinal slot along the length direction of the backing 100. The length extension direction of the side slot 102 is parallel to or obliquely intersecting with the width direction of the backing 100.

[0101] The traction segment 320 of the suture 300 may pass through the suture limiting structure so that a portion of the traction segment 320 is located on the first side of the backing 100 and another portion of the traction segment 320 is located on the second side of the backing 100 .

[0102] Specifically, the traction section 320 of the suture 300 can pass through the opening 101 and / or the slot from the first side of the backing 100 to the second side of the backing 100, thereby achieving the guiding effect of the suture limiting structure. The traction section 320 of the suture 300 can also pass through the opening 101 and / or the slot from the second side of the backing 100 to the first side of the backing 100, thereby achieving the guiding effect of the suture limiting structure.

[0103] The second aspect of the present disclosure provides a stapler 2000, comprising: the anastomotic reinforcement patch 1000 provided in the first aspect of the present disclosure, as well as an anvil assembly 2100 and a staple cartridge assembly 2200. The anastomotic reinforcement patch 1000 can be connected to the anvil assembly 2100 and the staple cartridge assembly 2200, and the anvil assembly 2100 is detachably connected to the anastomotic reinforcement patch 1000; the staple cartridge assembly 2200 is detachably connected to the anastomotic reinforcement patch 1000, and the staple cartridge assembly 2200 is configured to cooperate with the anvil assembly 2100 to staple the anastomotic reinforcement patch 1000 to tissue. Specifically, in response to the anastomotic reinforcement patch 1000 being assembled on the stapler assembly 2100 and the staple magazine assembly 2200, the stapler 2000 can be switched from an open state to a closed state, and further, the staples can be fired to make the staples penetrate through the two layers of the anastomotic reinforcement patch 1000 and the anastomotic stapling clamped by the stapler 2000.

[0104] In some embodiments, in response to the anastomotic reinforcement patch 1000 being assembled to the anvil assembly 2100 or the staple cartridge assembly 2200, as the anvil assembly 2100 or the staple cartridge assembly 2200 is assembled to the anastomotic reinforcement patch 1000 along the length direction of the backing 100, the backing 100 elastically expands and contracts in the width direction to wrap the anvil assembly 2100 or the staple cartridge assembly 2200. Since the backing 100 is elastic in the width direction, the anastomotic reinforcement patch 1000 provided by the present disclosure can be applied to various types of staplers 2000.

[0105] The biomaterial used in the patch 200 used in the anastomotic reinforcement patch 1000 product of the present application is selected from a degradable polymer material or a degradable animal-derived biomaterial. Preferably, the degradable animal-derived biomaterial includes dermal matrix, pericardium, peritoneum, bladder submucosa or small intestinal submucosa treated with immunogen removal, or a combination of these materials, such as a combination obtained by lamination, weaving, inlaying, etc. Preferably, it includes a decellularized small intestinal submucosa matrix material. The degradable polymer material can be selected from PGA, PLA or PLGA, or a combination of these materials, such as a combination obtained by lamination, weaving, inlaying, etc.

[0106] The specific structure, working principle, and beneficial effects of the anastomotic reinforcement patch and the stapler provided in the embodiments of the present disclosure may refer to the anastomotic reinforcement patch and the stapler described in any of the above embodiments, and will not be elaborated here.

[0107] Finally, it should be noted that the various embodiments in this specification are described in a progressive manner, and each embodiment focuses on the differences from other embodiments. The same or similar parts between the various embodiments can be referred to each other. For the system or device disclosed in the embodiment, since it corresponds to the method disclosed in the embodiment, the description is relatively simple, and the relevant parts can be referred to the method part description.

[0108] The above embodiments are only used to illustrate the technical solutions of the present disclosure, rather than to limit them. Although the present disclosure has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or make equivalent replacements for some of the technical features therein. However, these modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the embodiments of the present disclosure.

Claims

1. An anastomotic reinforcement patch, characterized in that: include: A backing, the backing having a first end and a second end in opposite directions in a length direction, and the backing having a first surface and a second surface facing away from each other in a thickness direction; A patch sheet, disposed on the first surface, the patch sheet being detachably connected to the backing; a suture, at least a portion of which is sutured to the patch and the backing so that the patch and the backing are detachably connected, An end cap is arranged at the first end and is used to accommodate the end of the stapler; the end cap and the backing are made of the same material, the end cap and the backing are made in one piece, or the end cap and the backing are made independently and then connected; The backing is an elastic material, which is made of 60%-90% nylon and 10%-40% spandex. The elastic properties of the elastic material are anisotropic and have obvious differences in orthogonal directions. The elasticity of the backing in the length direction is less than that in the width direction. The elastic material enables the backing to have different elongation at constant force in the width direction and the length direction. The elongation at constant force of the backing in the width direction is greater than or equal to 110% and less than or equal to 145%. The elongation at constant force of the backing in the length direction is less than or equal to 50%. The maximum force strength of the backing in the width direction and / or the length direction is not less than 220N.

2. The anastomotic reinforcement patch according to claim 1, characterized in that: The elongation at constant force of the backing in the length direction is smaller than the elongation at constant force of the backing in the width direction.

3. The anastomotic reinforcement patch according to claim 2, characterized in that: The backing has a constant elongation in the width direction of 120%, or 130%, or 140%.

4. The anastomotic reinforcement patch according to claim 2, characterized in that: The backing has a constant force elongation in the length direction of less than or equal to 45%.

5. The anastomotic reinforcement patch according to claim 2, characterized in that: The backing has a constant force elongation in the length direction of less than or equal to 40%.

6. The anastomotic reinforcement patch according to claim 1, characterized in that: The fixed force recovery rate of the backing is greater than or equal to 80%.

7. The anastomotic reinforcement patch according to claim 1, characterized in that: The fixed force recovery rate of the backing is greater than or equal to 90%.

8. The anastomotic reinforcement patch according to claim 1, characterized in that: The fixed force recovery rate of the backing is greater than or equal to 95%.

9. The anastomotic reinforcement patch according to claim 1, characterized in that: The minimum distance between the suture lines of the anastomotic reinforcement patch is 6 to 21 mm.

10. The anastomotic reinforcement patch according to claim 1, characterized in that: The minimum distance between the suture lines of the anastomotic reinforcement patch is 7mm, 8mm, 9mm, 10mm, 11mm, 12mm, 13mm, 14mm, 15mm, 16mm, 17mm, 18mm, 19mm or 20mm.

11. A stapler, characterized in that: include: The anastomotic reinforcement patch according to any one of claims 1 to 10; An anvil assembly configured to be detachably connected to the anastomotic reinforcement patch; and / or The staple cartridge assembly is detachably connected to the anastomotic reinforcement patch and is configured to cooperate with the staple holder assembly to staple the anastomotic reinforcement patch to the tissue.

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