staple cartridge assembly and stapler

By incorporating grippers within the staple cartridge assembly to fix tissue and reduce purse-string sutures, the problem of excessive removal of healthy tissue by existing circular staplers is solved, achieving the effect of preserving more healthy tissue in low rectal cancer surgery.

CN119279672BActive Publication Date: 2025-10-31SUZHOU YINGTUKANG MEDICAL TECH CO LTD
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Patent Information

Application Number
CN202411448472.3
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2024-10-17
Publication Date
2025-10-31
Estimated Expiration
2044-10-17

AI Technical Summary

Technical Problem

Existing circular staplers require the removal of too much healthy tissue during surgery, especially in low rectal cancer surgery, making it difficult to preserve as much healthy tissue as possible.

Method used

Design a staple cartridge assembly comprising a cartridge shell, an annular cartridge, a staple pusher, an annular cutter, and a gripper. The gripper secures tissue, reducing the need for purse-string sutures and requiring only the inner edge of the suture surface and the secured portion to be cut.

Benefits of technology

By using grippers to fix the tissue, the length of tissue cut is reduced, making it particularly suitable for intestinal surgery, especially low rectal cancer surgery, thus achieving the effect of preserving more healthy tissue.

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Abstract

This invention relates to a staple cartridge assembly and a stapler, belonging to the field of medical surgical instruments. The staple cartridge assembly includes: a cylindrical shell; staples for suturing tissue; an annular cartridge disposed within the cylindrical shell, having a suture surface, with a plurality of suture cavities formed within the annular cartridge for accommodating the staples, the suture cavities penetrating the suture surface; a staple pusher disposed within the suture cavities and located below the staples, the staple pusher pushing the staples to fire; an annular cutter disposed inside the annular cartridge, the annular cutter being movable relative to the annular cartridge in the axial direction of the cylindrical shell; and at least two gripping members, each gripping member including a gripping structure for fixing tissue, the gripping structure being disposed inside the annular cutter. This staple cartridge assembly helps to preserve more healthy tissue, and is particularly suitable for intestinal surgery, especially low rectal cancer surgery. By using this stapler, an anal-preserving effect can be achieved in low rectal cancer anastomosis.
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Description

Technical Field

[0001] This invention relates to a staple cartridge assembly and a stapler, belonging to the field of medical surgical instruments. Background Technology

[0002] Circular staplers are primarily used in anorectal suturing surgery. A circular stapler consists of a stapler body and an anvil assembly mounted on the stapler body. During the procedure, the target tissue (disease tissue) is first severed on both sides and sutured with a purse-string suture. The target tissue is then cut. The anvil assembly and stapler body are then placed on either side of the tissue to be sutured. Once the anvil assembly and stapler body are aligned, the circular stapler initiates a closing suture to reconnect the severed sections.

[0003] In the aforementioned surgical procedure, the purse-string sutured tissue is tensioned on the stapler body. After the circular stapler is closed, the purse-string sutured tissue is cut. In this type of surgery, because the tissue needs to be purse-string sutured, the outer edge of the purse-string suture is expected to be preserved by 5mm. The length of the portion to be cut while tensioned on the stapler body is approximately 12-14mm. Therefore, it is expected that 17-19mm of healthy tissue will be removed during the entire surgical procedure. However, in some existing surgeries (such as low rectal cancer surgery), it is necessary to preserve as much healthy tissue as possible or in surgeries with limited healthy tissue. Therefore, there is an urgent need to modify the structure of the existing circular stapler to preserve as much healthy tissue as possible. Summary of the Invention

[0004] The purpose of this invention is to provide a staple cartridge assembly that helps retain more healthy tissue.

[0005] To achieve the above objectives, the present invention provides the following technical solution: a staple cartridge assembly, comprising:

[0006] barrel shell;

[0007] Suture staples are used to suture tissue.

[0008] An annular chamber is disposed inside the cylindrical shell and has a suture surface. A plurality of suture cavities for accommodating the suture staples are formed inside the annular chamber, and the suture cavities penetrate the suture surface.

[0009] A pusher plate is disposed within the suture cavity and located below the suture staple; the pusher plate pushes the suture staple to fire.

[0010] An annular cutting blade is arranged inside the annular chamber, and the annular cutting blade is movable relative to the annular chamber in the axial direction of the cylindrical shell; and

[0011] At least two gripping elements, each of which includes a gripping structure for securing tissue to the side of the staple cartridge assembly, the gripping structure being arranged inside the annular cutter.

[0012] Furthermore, the gripping structure includes a hook portion for inserting into the tissue.

[0013] Furthermore, the hook portion has a straight hook for inserting into the tissue.

[0014] Furthermore, the axis of the straight hook forms an angle of no more than 90° with the inner side of the annular cutting blade, and the opening direction of the angle is away from the suture surface.

[0015] Furthermore, the hook portion has a curved hook for inserting into the tissue.

[0016] Furthermore, the hook is bent from one end in a direction away from the suture surface.

[0017] Furthermore, the hook extends in the circumferential direction.

[0018] Furthermore, each of the gripping members is characterized in that it includes at least two hook portions arranged in parallel along the circumferential direction.

[0019] Furthermore, the hook portion is provided with several barbs.

[0020] Furthermore, the gripping structure includes a supporting portion located inside the annular cutting blade and a folding portion pivotally connected to the supporting portion, wherein the folding portion folds towards the supporting portion to clamp the tissue.

[0021] Furthermore, the supporting portion has a first comb tooth for inserting into the tissue, and the folding portion has a second comb tooth that is intersected with the first comb tooth and is used for inserting into the tissue.

[0022] Furthermore, barbs are formed on the first and second comb teeth.

[0023] Furthermore, the gripping member also includes a connecting portion for fixing the gripping structure to the annular chamber body;

[0024] The annular cutting blade has a cutting edge portion, and an avoidance groove extending along the cutting direction of the annular cutting blade is formed on the annular cutting blade. A gap is formed between the avoidance groove and the cutting edge portion, and the connecting portion passes through the avoidance groove.

[0025] Furthermore, the annular cutting blade is defined with a first position before firing and a second position after firing. The part of the gripping structure that fixes the tissue is located at a position higher than the position of the blade portion of the annular cutting blade when it is in the first position, and lower than or equal to the suture surface.

[0026] This application also provides a stapler, including a stapler body and a stapler assembly disposed on the stapler body. The stapler body includes a rod assembly, a gripping assembly disposed on one end of the rod assembly, and the aforementioned staple cartridge assembly disposed on the other end of the rod assembly.

[0027] The beneficial effects of this invention are as follows: By incorporating a tissue-fixing gripper within the staple cartridge assembly, during use, once the staple cartridge assembly reaches the side of the tissue requiring suturing, the tissue on that side simply needs to be fixed to the gripper. After suturing and cutting are completed, the tissue fixed to the gripper is cut off, and the suturing work is completed simultaneously. Thus, purse-string sutures are not required on one side of the staple cartridge assembly. Because the tissue is fixed using the gripper, only the portion from the inner edge of the suture surface to the portion fixed by the gripper is cut off. Therefore, compared to existing purse-string suture methods, less tissue is cut off, thus helping to preserve more healthy tissue. This method is particularly suitable for intestinal surgery, especially low rectal cancer surgery, where the anastomosis and sphincter preservation effect can be achieved in low rectal cancer.

[0028] The above description is merely an overview of the technical solution of the present invention. In order to better understand the technical means of the present invention and to implement it in accordance with the contents of the specification, the preferred embodiments of the present invention are described in detail below with reference to the accompanying drawings. Attached Figure Description

[0029] Figure 1 This is a schematic diagram of the structure of the staple cartridge assembly and the anvil assembly according to an embodiment of the present invention;

[0030] Figure 2 for Figure 1 A partially exploded view of the staple cartridge assembly shown;

[0031] Figure 3 for Figure 1 Enlarged portion of the image;

[0032] Figure 4 for Figure 1 The diagram shows the structure of the anvil assembly.

[0033] Figure 5 This is a schematic diagram of the staple cartridge assembly according to another embodiment of the present invention;

[0034] Figure 6This is a schematic diagram of the structure of the staple cartridge assembly according to another embodiment of the present invention;

[0035] Figure 7 This is a schematic diagram of the staple cartridge assembly according to another embodiment of the present invention;

[0036] Figure 8 for Figure 7 A cross-sectional view of the gripper in the image. Detailed Implementation

[0037] The technical solution of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention. In the description of the present invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of the present invention. In addition, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance. In the description of the present invention, it should be noted that unless otherwise expressly specified and limited, the terms "installed," "connected," and "linked" should be interpreted broadly. 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; it can be a connection within two components. Those skilled in the art will understand the specific meaning of the above terms in this invention according to the specific circumstances. Furthermore, the technical features involved in the different embodiments of this invention described below can be combined with each other as long as they do not conflict with each other.

[0038] Example 1

[0039] Please see Figures 1 to 3 The stapler shown in a preferred embodiment of this application includes a stapler body and a stapler assembly 20 mounted on the stapler body. The stapler body includes a rod assembly, a gripping assembly disposed at one end of the rod assembly, and a staple cartridge assembly 10 disposed at the other end of the rod assembly. In this embodiment, the rod assembly and the gripping assembly can adopt existing structures, which will not be described in detail here.

[0040] The staple cartridge assembly 10 includes a cylindrical shell 11, an annular cartridge 12 disposed within the cylindrical shell 11, a plurality of staples (not shown) and a plurality of staple pushers (not labeled) disposed within the annular cartridge 12, an annular cutting blade 13 and a gripping member 14 arranged on the inner side of the annular cartridge 12. The structure of the cylindrical shell 11 can adopt an existing structure.

[0041] The annular chamber 12 has an inner wall 121 to enclose a receiving space 122. An annular cutter 13 and a gripper 14 are located within this receiving space 122. The annular cutter 13 is movable relative to the annular chamber 12 along the axial direction of the cylindrical shell 11. The annular chamber 12 also has a suture surface 123 facing the anvil assembly 20, so that it clamps the tissue (not labeled) to be sutured with the anvil assembly 20 in the closed state. A plurality of suture cavities 124 are formed within the annular chamber 124, penetrating the suture surface 123. Suture staples are used to suture the tissue, with each staple corresponding to one suture cavity 124 and housed within that cavity. A staple pusher is arranged at least within the suture cavity 124 and corresponding to the staple, located below it. The staple pusher is used to push the staple to fire, thereby suturing the tissue to be sutured.

[0042] The number of grippers 14 is at least two. In this embodiment, the grippers 14 are arranged at equal intervals along the circumference. Each gripper 14 includes a gripping structure 141 for securing tissue on the side of the staple cartridge assembly 10. The gripping structure 141 is arranged inside the annular cutter 13.

[0043] By incorporating a gripper 14 within the staple cartridge assembly 10 to secure the tissue on one side, when the stapler is used, once the staple cartridge assembly 10 reaches the side of the tissue requiring suturing, the tissue on that side simply needs to be secured to the gripper 14. After suturing and cutting are completed, the tissue secured to the gripper 14 is cut off, and the suturing is completed simultaneously. Thus, purse-string sutures are not required on one side of the staple cartridge assembly 10. Because the tissue is secured by the gripper 14, only the portion of the tissue from the inner edge of the suture surface to the portion secured by the gripper 14 is cut off. Therefore, compared to existing purse-string suture methods, less tissue is cut off, thus helping to preserve more healthy tissue. This method is particularly suitable for intestinal surgery, especially low rectal cancer surgery, where this stapler can achieve anastomosis and sphincter preservation in low rectal cancer.

[0044] It should be noted that, through testing, when using this stapler, the length of the cut tissue comprises two segments. The first segment is the distance between the location of the tissue-fixing portion of the gripper 14 and the tissue's cut surface, which is typically (not exceeding) 5 mm. The second segment is the distance between the location of the tissue-fixing portion of the gripper 14 and the inner edge of the suture surface 123, which is determined based on the position of the gripper 14 and typically does not exceed 3 mm. Thus, the length of the cut tissue is approximately (not exceeding) 8 mm.

[0045] In one embodiment, please refer to Figures 2 to 4 The gripping structure 141 is a hook portion 141 for inserting into the tissue. By inserting the hook portion 141 into the tissue, the tissue is fixed. This structure is simple, and during surgery, the tissue is simply pulled onto the hook portion 141, making operation convenient. In an alternative embodiment, the hook portion 141 is a curved hook 141 for inserting into the tissue. In this embodiment, the curved hook 141 is bent from one end in a direction away from the suture surface 123. In other embodiments, the curved hook 141 may also extend in the circumferential direction. This curved hook 141 makes the tissue fixed thereon more secure, helping to prevent tissue detachment.

[0046] In another alternative embodiment, the hook portion has a straight hook for inserting into the tissue, thereby securing the tissue and simplifying the operation. To prevent tissue detachment, the axis of the straight hook forms an angle of no more than 90° with the inner surface of the annular cutting blade, with the opening direction of the angle facing away from the suture surface.

[0047] In the above embodiment, the number of hook portions 141 formed on each gripper 14 is one. However, in other embodiments, please refer to [link to other embodiments]. Figure 5 Each gripper 14 includes two hook portions 141 arranged in parallel along the circumference. Of course, the number of hook portions 141 can also be greater than two. The hook portions 141 arranged in parallel on each gripper 14 are connected by a connecting rod portion 143. This arrangement can distribute the force on the tissue on each gripper 14 and prevent tissue tearing.

[0048] To increase the gripping force of the gripper 14 on the tissue, several barbs may also be formed on the hook portion 141.

[0049] To facilitate securing the gripper 14, the gripper 14 further includes a connecting portion 142 for fixing the gripping structure 141 to the annular chamber 12. The connecting portion 142 extends radially from the inner sidewall 121 along the annular chamber 12, and the hook portion 141 is formed by bending from the end of the connecting portion 142 away from the inner sidewall 121. By providing the connecting portion 142 on the inner sidewall 121, the size of the gripper 14 can be reduced.

[0050] Since the annular cutting blade 13 needs to move relative to the annular housing 12 along the axial direction, and to prevent interference between the connecting part 142 and the annular cutting blade 13, a clearance groove 131 extending along the cutting direction of the annular cutting blade 13 is formed on the annular cutting blade 13. The annular cutting blade 13 has a cutting edge 132, and a gap is formed between the clearance groove 131 and the cutting edge 132. The connecting part 142 passes through the clearance groove 131. Because there is a gap between the clearance groove 131 and the cutting edge 132, the clearance groove 131 will not penetrate the cutting edge 132, thus preventing the cutting connection from breaking.

[0051] The annular cutting blade 13 is defined by a first position before firing and a second position after firing. In the first position ( Figure 1 In the position shown, the blade portion 132 of the annular cutting blade 13 does not extend beyond the suture surface 123, and in the axial direction, the blade portion 132 is lower than the suture surface 123; in the second position, the blade portion 132 extends beyond the suture surface 123 and enters the receiving cavity 25 of the anvil assembly 20.

[0052] To minimize tissue cutting, the hook portion 141 is positioned such that the tissue-fixing portion of the hook portion 141 is higher than the position of the blade portion 132 of the annular cutter 13 in its first position, but lower than or equal to the suture surface 123. Specifically, in this embodiment, the hook portion 141 as a whole does not exceed the position of the blade portion 132 of the annular cutter 13 in its first position. Typically, the distance between the tissue-fixing portion of the hook portion 141 and the position of the blade portion 132 is 0.5 mm. With this arrangement, and considering that the axial projection distance between the blade portion 132 and the suture surface 123 is approximately 1 mm, the distance between the tissue-fixing portion of the hook portion 141 and the inner edge of the suture surface 123 is approximately 3 mm.

[0053] Of course, in order to further reduce the length of the cut tissue, in the axial direction, the position of the part of the hook portion 141 that fixes the tissue can be set as close as possible to the suture surface 123, see Figure 5 and Figure 6 The portion of the hook 141 that holds the tissue is positioned higher than the blade 132 of the annular cutting blade 13 and is approximately flush with the suture surface 123.

[0054] Please combine Figure 1 and Figure 5In this embodiment, the anvil assembly 20 is detachably connected to the stapler body. The anvil assembly 20 has an anvil head 21 and an anvil rod 22. A closing surface 23 is formed on the anvil head 21. After the anvil assembly 20 and the stapler are docked, the closing surface 23 faces the suture surface 123, and a plurality of staple pits 24 are formed on the closing surface 23. The anvil rod 22 has a plurality of clamping parts 221. The insertion rod (not shown) inside the stapler body is inserted into the clamping parts 221, thereby realizing the docking of the anvil assembly 20 and the stapler body.

[0055] Example 2

[0056] Please see Figure 7 and Figure 8 The circular stapler provided in this embodiment has a structure largely the same as that of the stapler in Embodiment 1, the difference being in the gripping structure. Specifically, the gripping structure 141 in this embodiment includes a supporting portion 1411 located inside the annular cutting blade 13 and a folding portion 1412 pivotally connected to the supporting portion 1411. The folding portion 1412 folds towards the supporting portion 1411 to clamp the tissue. The supporting portion 1411 and the folding portion 1412 are arranged axially, and the axis of their pivot connection is perpendicular to the axial direction. The supporting portion 1411 is fixed to the inner wall of the annular chamber 12 by a connecting portion 142.

[0057] The retaining structure 141 in this embodiment also includes a bent spring piece 1413 that is secured between the supporting portion 1411 and the folding portion 1412. A latching portion 1414 for latching onto the supporting portion 1411 is formed at the end of the folding portion 1412.

[0058] It should be noted that the holding structure can also be as follows: the holding part has a plurality of first comb teeth for inserting into the tissue, and the folding part has a plurality of second comb teeth that are intersected with the plurality of first comb teeth and are for inserting into the tissue, thereby improving the holding force of the holding structure relative to the tissue. Furthermore, in order to further improve the fixation of the tissue, barbs can be formed on the plurality of first comb teeth and second comb teeth.

[0059] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0060] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the protection scope of the present invention. Therefore, the protection scope of this invention patent should be determined by the appended claims.

Claims

1. A staple cartridge assembly, characterized in that, include: barrel shell; Suture staples are used to suture tissue. An annular chamber is disposed inside the cylindrical shell and has a suture surface. A plurality of suture cavities for accommodating the suture staples are formed inside the annular chamber, and the suture cavities penetrate the suture surface. A pusher plate is disposed within the suture cavity and located below the suture staple; the pusher plate pushes the suture staple to fire. An annular cutting blade is arranged inside the annular chamber, and the annular cutting blade can move relative to the annular chamber in the axial direction of the cylindrical shell; and At least two gripping elements, each of the gripping elements including a gripping structure for securing tissue on the side of the staple cartridge assembly, the gripping structure being arranged inside the annular cutter; When in use, after the staple cartridge assembly reaches the side of the tissue that needs to be sutured, the tissue on that side can be fixed to the gripper so that the staple cartridge assembly side does not need to be purse-string sutured. The gripping member further includes a connecting portion for fixing the gripping structure to the annular chamber; the connecting portion extends from the inner sidewall of the annular chamber along the radial direction of the annular chamber.

2. The staple cartridge assembly as described in claim 1, characterized in that, The gripping structure includes a hook portion for inserting into the tissue.

3. The staple cartridge assembly as described in claim 2, characterized in that, The hook portion has a straight hook for inserting into the tissue.

4. The staple cartridge assembly as described in claim 3, characterized in that, The axis of the straight hook forms an angle of no more than 90° with the inner side of the annular cutting blade, and the opening direction of the angle is away from the suture surface.

5. The staple cartridge assembly as described in claim 2, characterized in that, The hook portion has a curved hook for inserting into the tissue.

6. The staple cartridge assembly as described in claim 5, characterized in that, The hook is bent from one end in a direction away from the suture surface.

7. The staple cartridge assembly as described in claim 5, characterized in that, The hook extends in the circumferential direction.

8. The staple cartridge assembly as described in any one of claims 2-6, characterized in that, Each of the gripping elements includes at least two hook portions arranged in parallel along the circumferential direction.

9. The staple cartridge assembly as described in any one of claims 2-7, characterized in that, The hook portion has several barbs.

10. The staple cartridge assembly as claimed in claim 1, characterized in that, The gripping structure includes a supporting portion located inside the annular cutting blade and a folding portion pivotally connected to the supporting portion. The folding portion folds towards the supporting portion to clamp the tissue.

11. The staple cartridge assembly as described in claim 10, characterized in that, The supporting portion has a first comb tooth for inserting into the tissue, and the folding portion has a second comb tooth that is intersected with the first comb tooth and is used for inserting into the tissue.

12. The staple cartridge assembly as described in claim 11, characterized in that, The first and second comb teeth have barbs formed on them.

13. The staple cartridge assembly as described in claim 1, characterized in that, The annular cutting blade has a cutting edge portion, and an avoidance groove extending along the cutting direction of the annular cutting blade is formed on the annular cutting blade. A gap is formed between the avoidance groove and the cutting edge portion, and the connecting portion passes through the avoidance groove.

14. The staple cartridge assembly as described in claim 13, characterized in that, The annular cutting blade is defined with a first position before firing and a second position after firing. The part of the gripping structure that fixes the tissue is located at a position higher than the position of the blade portion of the annular cutting blade when it is in the first position, and lower than or equal to the suture surface.

15. A stapler, characterized in that, The device includes a stapler body and a stapler assembly disposed on the stapler body. The stapler body includes a rod assembly, a gripping assembly disposed at one end of the rod assembly, and a staple cartridge assembly as described in any one of claims 1-14 disposed at the other end of the rod assembly.

Citation Information

Patent Citations

  • Tissue retention spool for intraluminal anastomotic surgical stapling instrument and methods

    EP0137685A2

  • Intraluminal stapling device with tissue gripper

    EP0190022A2