anastomat
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- BEIJING BIOSIS HEALING BIOLOGICAL TECH CO LTD
- Filing Date
- 2026-02-12
- Publication Date
- 2026-05-26
Smart Images
Figure CN121694826B_ABST
Abstract
Description
Technical Field
[0001] This disclosure relates to the field of medical devices, and more specifically, to a stapler. Background Technology
[0002] The application of staplers has greatly promoted the development of modern surgery and minimally invasive surgery, marking a milestone. Staplers can simultaneously cut and fix tissues with staples, and are widely used for cutting, suturing, or anastomosing organs such as the intestines, stomach, lungs, and pancreas. However, the rigidity of staples alone cannot completely prevent leakage and bleeding at the anastomosis site. This is because the staples are rigid structures that cannot perfectly match the flexibility of soft tissues, leading to leakage and bleeding at the staple holes. Furthermore, due to differences in the characteristics of soft tissues in different areas, some soft tissues, such as the lungs, have lower strength, potentially posing a risk of anastomotic tearing. To address these issues, anastomotic reinforcement patches can be used in conjunction with staplers. This allows the stapler to cut and close the wound while simultaneously fixing the reinforcement patch to the wound, sealing the staple holes, increasing wound strength, and thus preventing leakage and bleeding. Summary of the Invention
[0003] The purpose of this disclosure is to provide a stapler that addresses the technical problems in related technologies. The specific solution is as follows:
[0004] This application provides a stapler configured to reduce fluid resistance at the anastomosis site, comprising: an anvil assembly including an anvil with an anvil end face; a staple cartridge assembly including a staple cartridge and an annular blade, the annular blade being movably disposed within the staple cartridge, the staple cartridge having a staple cartridge end face; and a fixing patch, the fixing patch being an annular structure including a first patch and a second patch, the first patch including a first aperture and a first cutting position, the first cutting position penetrating the first aperture; and the second patch including a second aperture and a second cutting position, the second cutting position penetrating the second aperture. The stapler has an installed state and a firing state. In response to the stapler being in the installed state, the anvil assembly is assembled to the staple cartridge assembly. In response to the stapler being in the firing state, the annular blade cuts the fixing patch along the first cutting position and the second cutting position. The annular structure inside the first cutting position and the second cutting position detaches from the fixing patch. The remaining portion of the first hole and the second hole forms an opening on one side facing the first cutting position or the second cutting position, configured to disperse the circumferential stress of the inner diameter of the first patch and the second patch.
[0005] In some embodiments, the first pore portion and the second pore portion have the same shape and size, and are configured to allow the fluid to have the same hydrostatic pressure through the first patch and the second patch.
[0006] In some embodiments, in the radial direction of the first patch, the first aperture has a first end adjacent to the inner ring and a second end adjacent to the outer ring, and the distance from the first cut position to the second end is greater than 1 / 2 of the distance from the first cut position to the edge of the outer ring.
[0007] In some embodiments, the width of the first aperture portion in the circumferential direction of the first patch is 0.01-2.4 mm.
[0008] In some embodiments, the width of the first end is smaller than the width of the second end in the circumferential direction of the first patch.
[0009] In some embodiments, the anvil end face is provided with a first positioning post, and the staple cartridge end face is provided with a second positioning post, configured to ensure that the fixing patch is accurately assembled onto the anvil and / or the staple cartridge.
[0010] In some embodiments, the projections of the first positioning post and the second positioning post do not coincide in the axial direction of the stapler, configured to reduce the gap between the anvil and the staple cartridge.
[0011] In some embodiments, the staple cartridge assembly includes: a connecting wire passing through a connecting hole in the second patch, configured to connect the second patch to the staple cartridge.
[0012] In some embodiments, the stapler further includes: a tubular connecting assembly connected to the staple cartridge; and an elastic connector sleeved on the tubular connecting assembly, configured to connect to a second patch via a connecting line so that the second patch covers the end face of the staple cartridge.
[0013] In some embodiments, the staple cartridge further includes a lead groove disposed on the outer side wall of the staple cartridge, configured to prevent the connecting wire from tangling around the end face of the staple cartridge.
[0014] Compared with related technologies, the above-described solutions of this disclosure have at least the following beneficial effects:
[0015] In the anastomosis device provided in this disclosure, the first patch and the second patch respectively have a first pore portion and a second pore portion. In response to an external annular blade cutting the fixed patch along a first cutting position and a second cutting position, the inner ring edge of the fixed patch is toothed. The toothed structure allows the anastomosis site to exhibit a relatively relaxed state around its diameter after cutting, weakening the circumferential stress at the anastomosis site and reducing fluid resistance at the anastomosis site.
[0016] It should be understood that the above general description and the following detailed description are exemplary and explanatory only, and are not intended to limit this disclosure. Attached Figure Description
[0017] The accompanying drawings, which are incorporated in and form part of this specification, illustrate embodiments consistent with this disclosure and, together with the description, serve to explain the principles of this disclosure. It is obvious that the drawings described below are merely some embodiments of this disclosure, and those skilled in the art can obtain other drawings based on these drawings without any inventive effort. In the drawings:
[0018] Figure 1 This is a schematic diagram of the structure of a stapler according to an exemplary embodiment.
[0019] Figure 2 This is a schematic diagram of a nail anvil assembly equipped with a first patch, according to an exemplary embodiment.
[0020] Figure 3 This is a partial exploded view of an anvil assembly according to an exemplary embodiment.
[0021] Figure 4 This is a schematic diagram of the structure of an anvil according to an exemplary embodiment.
[0022] Figure 5 This is a schematic diagram of the structure of a staple cartridge assembly according to an exemplary embodiment.
[0023] Figure 6 This is a schematic diagram illustrating the assembly of a staple cartridge assembly and a tubular connecting assembly according to an exemplary embodiment.
[0024] Figure 7 This is a schematic diagram illustrating the structure of a first patch according to an exemplary embodiment.
[0025] Figure 8 This is a perspective view of an anvil fitted with a first patch, according to an exemplary embodiment.
[0026] Figure 9 This is a schematic diagram of the structure of a second patch according to an exemplary embodiment.
[0027] Figure 10 This is a schematic diagram illustrating the structure of a cut second patch according to an exemplary embodiment.
[0028] Figure 11 This is a cross-sectional view of a staple cartridge according to an exemplary embodiment.
[0029] Figure label:
[0030] Nail anvil assembly 1000, nail head 1100, nail head connector 1110, nail anvil 1200, nail anvil end face 1210, first positioning post 1211, nail groove 1212, knife pad ring 1220, central shaft assembly 1230;
[0031] 2000 staple cartridge assembly, 2001 lead wire groove, 2100 staple cartridge, 2210 staple cartridge end face, 2211 second positioning post, 2201 staple placement groove, 2220 ring blade, 2300 shaft core, 2310 third connecting part, 2400 connecting wire;
[0032] Fixed patch 3000, first patch 3100, first body part 3110, first hole part 3101, first end 3111, second end 3112, first cutting position 3102, first positioning hole 3103, first side slot 3104, first connecting part 3120, first fastening part 3131, second fastening part 3132;
[0033] Second patch 3200, second body part 3210, second hole part 3201, second cutting position 3202, second positioning hole 3203, second side slot 3204, second connecting part 3220, second connecting hole 3221;
[0034] Tubular connection assembly 4000, elastic connector 4100, first connection hole 4101;
[0035] Grip 5000, firing handle 5100, safety pin 5200. Detailed Implementation
[0036] To make the objectives, technical solutions, and advantages of this disclosure clearer, the disclosure will be further described in detail below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of this disclosure, and not all of them. Based on the embodiments of this disclosure, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this disclosure.
[0037] The terminology used in the embodiments of this disclosure is for the purpose of describing particular embodiments only and is not intended to limit the disclosure. The singular forms “a,” “the,” and “the” as used in the embodiments of this disclosure and the appended claims are also intended to include the plural forms, unless the context clearly indicates otherwise; “multiple” generally includes at least two, and other quantifiers are similarly intended.
[0038] It should be understood that although the terms first, second, third, etc., may be used to describe embodiments of this disclosure, these descriptions should not be limited to these terms. These terms are only used to distinguish the described objects. For example, first may also be referred to as second without departing from the scope of embodiments of this disclosure, and similarly, second may also be referred to as first. Furthermore, the terms "first," "second," "third," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance.
[0039] It should be understood that the term "and / or" as used herein is merely a description of the relationship between related objects, indicating that three relationships can exist. For example, A and / or B can represent: A alone, A and B simultaneously, and B alone. Additionally, the character " / " in this document generally indicates that the preceding and following related objects have an "or" relationship. The singular forms "a," "the," and "the" are also intended to include the plural forms unless the context clearly indicates otherwise.
[0040] It is further understood that the terms “center,” “longitudinal,” “lateral,” “front,” “rear,” “up,” “down,” “left,” “right,” “vertical,” “horizontal,” “top,” “bottom,” “inner,” and “outer,” etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this embodiment 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. Therefore, they should not be construed as limitations on the present invention.
[0041] In the description of this disclosure, it should be noted that, unless otherwise expressly specified and limited, the terms "connected" and "linked" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.
[0042] Depending on the context, the words “if” or “suppose” as used here can be interpreted as “when” or “in response to determination” or “in response to detection.” Similarly, depending on the context, the phrases “if determination” or “if detection (of the stated condition or event)” can be interpreted as “when determination” or “in response to determination” or “when detection (of the stated condition or event)” or “in response to detection (of the stated condition or event).”
[0043] It should also be noted that the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that an article or device that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such an article or device. Without further limitation, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the article or device that includes said element.
[0044] In related technologies in this field, the anastomotic reinforcement patch used in staplers is mostly rectangular, arc-shaped, or ring-shaped. Among them, the ring-shaped anastomotic reinforcement patch is used in conjunction with a tubular stapler in practical applications. When the cutting blade of the tubular stapler cuts off the anastomotic reinforcement patch, the inner ring of the anastomotic reinforcement patch and the inner ring of the cut portion of the anastomosis together form a circular incision. At this time, the anastomosis is clamped by two anastomotic reinforcement patches with circular inner rings. Because the inner ring structure of the anastomotic reinforcement patch is intact and the edge of the anastomotic reinforcement patch is a continuous structure, when fluid passes through the anastomosis, the support force provided by the anastomotic reinforcement patch to the edge of the anastomosis is relatively large, which may lead to poor fluid flow and local embolism.
[0045] To address the aforementioned technical problems, this disclosure provides an anastomosis device configured to reduce fluid resistance at the anastomosis site, comprising: an anvil assembly including an anvil with an anvil end face; a staple cartridge assembly including a staple cartridge and a ring-shaped blade movably disposed within the staple cartridge, the staple cartridge having a staple cartridge end face; and a fixing patch, the fixing patch being an annular structure including a first patch and a second patch, the first patch including a first aperture and a first cutting position, the first cutting position penetrating the first aperture; and the second patch including a second aperture and a second cutting position, the second cutting position penetrating the second aperture.
[0046] The stapler has an installed state and a firing state, and in response to the stapler being in the installed state, the anvil assembly is assembled to the staple cartridge assembly;
[0047] In response to the stapler being in the firing state, the annular blade cuts the fixing patch along the first and second cutting positions. The annular structure inside the first and second cutting positions disengages from the fixing patch. The remaining portions of the first and second apertures form an opening facing the first or second cutting position, configured to distribute the stress between the first and second patches.
[0048] In the anastomosis device provided in this disclosure, the first patch and the second patch respectively have a first pore portion and a second pore portion. In response to an external annular blade cutting the fixed patch along a first cutting position and a second cutting position, the inner ring edge of the fixed patch is toothed. The toothed structure allows the anastomosis site to exhibit a relatively relaxed state around its diameter after cutting, weakening the circumferential stress at the anastomosis site and reducing fluid resistance at the anastomosis site.
[0049] The optional embodiments of this disclosure are described in detail below with reference to the accompanying drawings.
[0050] This disclosure provides an anastomosis device with a special structure for fixing a patch 3000, such as... Figure 1As shown, it includes: anvil assembly 1000, staple cartridge assembly 2000, and fixing patch 3000.
[0051] In some embodiments, such as Figure 2 , Figure 3 , Figure 4 As shown, the anvil assembly 1000 includes an anvil 1200. The sidewall of the anvil 1200 is generally conical, configured to provide a support platform for the staples to deform. The staple head 1100 is connected to the anvil 1200 via a staple head connector 1110, so that a portion of the fixing patch 3000 is fixed to the anvil 1200. The anvil 1200 has an anvil end face 1210 on the side away from the staple head 1100. The anvil end face 1210 is provided with an anvil groove 1212, which provides a support platform for the staples, allowing the staples to deform under compression.
[0052] Specifically, the anastomosis groove 1212 is used to compress and deform the staple. Further, the fixation patch 3000 is sutured. The fixation patch 3000, sutured by the staple, is connected to the human tissue, and the cut portion of the fixation patch 3000, along with the human tissue, is cut off by the annular blade 2220 of the staple cartridge assembly 2000.
[0053] In some embodiments, the anvil assembly 1000 further includes a blade pad ring 1220, such as Figure 3 As shown, the cutting pad ring 1220 is disposed inside the anvil 1200 to assist external force in cutting the fixed patch 3000, so that the fixed patch 3000 is neatly cut on the cutting pad ring 1220. The cutting pad ring 1220 is constructed as a ring structure, and the outer diameter of the cutting pad ring 1220 is larger than the inner diameter of the first patch 3100 to prevent the cutting pad ring 1220 from coming out of the inner diameter of the first patch 3100.
[0054] In some embodiments, the staple cartridge assembly 2000 includes a staple cartridge 2100, such as Figure 5 As shown, the staple cartridge 2100 has a staple cartridge end face 2210, which is provided with a staple placement groove 2201 configured to accommodate anastomotic staples. A portion of the fixation patch 3000 covers the staple cartridge end face 2210 and is used in conjunction with the staple cartridge assembly 2000 to repair the anastomosis. The staple cartridge 2100 also contains a ring cutter 2220, which is axially movable to cut the fixation patch 3000. Simultaneously, the anastomosis is repaired by suturing the fixation patch 3000 and the anastomosis using anastomotic staples.
[0055] In some embodiments, the fixing patch 3000 is a ring structure, including: a first patch 3100 and a second patch 3200, such as... Figure 2 , Figure 4 , Figure 6 and Figure 7 As shown, the first patch 3100 is assembled on the anvil end face 1210 and configured to cover the anvil groove 1212; the second patch 3200 is assembled on the staple cartridge end face 2210 and configured to cover the staple placement groove 2201. In response to the firing of the anastomotic staple in the staple cartridge 2100, the anastomotic staple penetrates the first patch 3100 and the second patch 3200, so that the fixing patch 3000 is stapled to the anastomosis, thereby realizing the repair of the anastomosis by the fixing patch 3000.
[0056] In some embodiments, such as Figure 7 As shown, the first patch 3100 includes a first body portion 3110 and a first connecting portion 3120. The first body portion 3110 covers the anvil end face 1210, and the first connecting portion 3120 has a toothed structure, with at least a portion of the first connecting portion 3120 clamped between the nail head 1100 and the anvil 1200. The first connecting portion 3120 and the first body portion 3110 are integrally formed and configured to stably assemble the first body portion 3110 onto the anvil 1200.
[0057] Specifically, such as Figure 2 , Figure 3 As shown, since the sidewall of the anvil 1200 is conical, and the patch connecting part used in related technologies is cylindrical, the patch cannot completely wrap around the anvil 1200. Therefore, in this disclosure, the first connecting part 3120 has a toothed structure, and the angle between the first connecting part 3120 and the plane containing the first body part 3110 is less than 90 degrees. The outer periphery of the toothed structure is relatively soft and has advantages such as high tension, good relaxation, and strong expandability, which can wrap around the anvil 1200 and avoid displacement of the first patch 3100 on the anvil 1200 due to poor matching between the first patch 3100 and the anvil 1200 or large pressing gap, thus affecting the suturing effect. Correspondingly, the edge of the nail head 1100 also has a serrated structure, and the serrated structure of the edge of the nail head 1100 corresponds one-to-one with that of the first connecting portion 3120, so that the nail head 1100 can work together with the anvil 1200 to clamp the first connecting portion 3120, and so that the first patch 3100 is stably assembled on the anvil 1200. The anvil assembly 1000 further includes a central shaft assembly 1230, which passes through the anvil 1200 and engages with the nail head 1100, so that the nail head 1100 has a pressing tendency towards the anvil 1200, thereby clamping the first connecting portion 3120.
[0058] The serrated structure of the 3000 biomaterial fixation patch is expandable. At the anastomotic flow site, the added serrated structure forms a protective layer, enhancing protection. Compared to a ring-shaped reinforcement patch after cutting, the serrated structure, combined with the elasticity of the tissue and material itself, allows for greater expansion at the anastomosis site during fluid flow, facilitating fluid passage and preventing localized blockage.
[0059] In some embodiments, the first connecting portion 3120 includes a first side slot 3104, the first side slot 3104 being disposed on the side of the first connecting portion 3120, the end of the first side slot 3104 extending to the edge of the main body portion, configured to make it easier for the first patch 3100 to be connected to the anvil 1200.
[0060] In some embodiments, such as Figure 7 As shown, the first body portion 3110 has an annular structure. The surface of the annular structure has a first cutting position 3102 and a first aperture portion 3101, with the first cutting position 3102 penetrating through the first aperture portion 3101. In response to the annular blade 2220 cutting the first cutting position 3102, the annular structure inside the first cutting position 3102 detaches from the first body portion 3110, and the remaining portion of the first aperture portion 3101 forms an open opening on the side facing the first cutting position 3102. The inner circumference of the first aperture portion 3101 and the first cutting position 3102 together form a toothed structure. The toothed structure can reduce the flow resistance at the anastomosis, allowing the fluid at the anastomosis to pass smoothly.
[0061] In some embodiments, the width of the first aperture 3101 in the tangential direction of the fixed patch 3000 is not less than 0.1 mm. The width of the first aperture 3101 is set such that it does not cover the staple placement groove 2201 of the staple cartridge end face 2210. If the first aperture 3101 covers the staple placement groove 2201, after the stapler is fired, the tissue at the staple joint and the overall thickness of the patch will be uneven, posing a risk of poor staple formation.
[0062] In some embodiments, the surface of the first body portion 3110 is provided with at least two first holes 3101, and there is a preset distance between the two first holes 3101, the preset distance being able to accommodate external staples.
[0063] In some embodiments, in order to ensure that the inner ring of the cut first body portion 3110 has a complete toothed structure, the first hole portion 3101 needs to avoid the anvil groove 1212. Therefore, in the circumferential direction of the first body portion 3110, the spacing between the plurality of first hole portions 3101 is 0.2-7mm, and the distance between two adjacent first hole portions 3101 can at least accommodate one matching nail.
[0064] In some embodiments, the first body portion 3110 includes a plurality of first aperture portions 3101, the first aperture portions 3101 penetrating through the surface of the first body portion 3110 and covering at least a portion of the first cutting position 3102, that is, the first cutting position 3102 penetrating through the first aperture portion 3101.
[0065] Specifically, the first patch 3100 is used in conjunction with the anvil 1200 to repair the anastomosis. When the first patch 3100 is assembled onto the anvil 1200, the first body portion 3110 fits against the anvil end face 1210 of the anvil 1200, and the first connecting portion 3120 is sleeved on the side of the anvil 1200, so that the first patch 3100 and the anvil 1200 are stably connected. In response to the annular blade 2220 cutting the first patch 3100 along the first cutting position 3102, the inner ring edge of the first body portion 3110 has a toothed structure. The toothed structure can disrupt the complete inner ring structure formed by the fluid on the surface of the annular inner ring. The radial stress of the complete inner ring is large, which will increase the fluid resistance when the fluid passes through the annular structure. The toothed structure makes the boundary layer unstable, thereby reducing the flow resistance and facilitating smoother fluid flow. On the other hand, when fluid passes through the anastomosis, the toothed first patch 3100 can increase the flow area of the fluid, allowing more fluid to pass through to a certain extent. Especially when the fluid flow rate is large, it helps to alleviate congestion and avoid poor flow.
[0066] In some embodiments, if the first pore portion 3101 is set independently, it may cause uneven flow of fluid in the inner ring of the annulus, with some areas having a larger flow rate and some areas having a smaller flow rate. This uneven flow may cause local wear of the first patch 3100 or insufficient support force on the edge of the mating joint, which may affect the performance of the entire system. In order to avoid this uneven flow, a plurality of first pore portions 3101 are provided in the circumferential direction of the first body portion 3110, and the plurality of first pore portions 3101 are evenly arranged.
[0067] In some embodiments, such as Figure 7 As shown, in the radial direction of the annular structure of the first body portion 3110, the first pore portion 3101 has a first end 3111 adjacent to the inner ring and a second end 3112 adjacent to the outer ring.
[0068] In some embodiments, the width of the first end 3111 in the circumferential direction of the first body portion 3110 may be the same as or different from the width of the second end 3112; preferably, the width of the first end 3111 in the circumferential direction of the first body portion 3110 is greater than the width of the second end 3112; or the width of the first end 3111 in the circumferential direction of the first body portion 3110 is less than the width of the second end 3112.
[0069] In some embodiments, the width of the first end 3111 is smaller than the width of the second end 3112 in the circumferential direction of the annular structure of the first body portion 3110. Under this shape and structure limitation, when the outer annular blade 2220 cuts the first body portion 3110 along the first cutting position 3102, the toothed structure formed by the inner ring of the first body portion 3110 has a shape and structure that gradually narrows from the base to the tooth tip. This toothed structure makes it easier to reduce the radial force at the anastomosis edge, making the fluid more stable and smooth when passing through the anastomosis, and less prone to clogging.
[0070] In some embodiments, the distance from the first cut position 3102 to the second end 3112 is greater than half the distance from the first cut position 3102 to the outer ring edge. The distance from the first cut position 3102 to the outer ring edge of the first body portion 3110 is the depth to which the first pore portion 3101 can expand for the anastomosis. The greater the distance from the first cut position 3102 to the outer ring edge of the first body portion 3110, the greater the flow resistance can be reduced for the fluid passing through the anastomosis. If the distance from the first cut position 3102 to the outer ring edge of the first body portion 3110 is too small, the inner ring portion of the first body portion 3110 will still cause significant resistance to the fluid when it passes through the anastomosis, affecting the continuous flow of fluid.
[0071] In some embodiments, such as Figure 7 , Figure 8As shown, the first body portion 3110 further includes a first engagement portion 3131 and a second engagement portion 3132. The first engagement portion 3131 is located between two adjacent first aperture portions 3101 and is configured to accommodate an external anastomotic staple. The second engagement portion 3132 is located between the second end 3112 and the outer ring edge and is configured to accommodate an external anastomotic staple. When the anastomosis reinforcement patch is assembled onto the anvil 1200, in response to the firing of the anastomotic staple, the anastomotic staple penetrates the first engagement portion 3131 and the second engagement portion 3132 respectively, realizing the engagement of the first body portion 3110 with the area around the anastomosis. In the axial direction of the first body portion 3110, the positions of the first engagement portion 3131 and the second engagement portion 3132 avoid the first aperture portion 3101. After the staple is fired, neither the tip of the staple nor the staple body will penetrate the first aperture portion 3101. That is, the firing of the staple does not affect the opening of the first aperture portion 3101.
[0072] In some embodiments, when the first patch 3100 is used in conjunction with the anvil 1200, the first patch 3100 covers the end face of the anvil 1200. In response to the first patch 3100 being fitted onto the anvil 1200, the first engagement portion 3131 and the second engagement portion 3132 of the first patch 3100 cover the anvil groove 1212. After the stapler is fired, the staples will press together at the location of the anvil groove 1212 to form a "B-shaped" structure, further suturing the first patch 3100 to the anastomosis. The first patch 3100 sutured by the staples is connected to the human tissue, and the cut portion of the first patch 3100 is cut off along with the human tissue by the circular blade 2220.
[0073] In some embodiments, the width of the first pore portion 3101 in the circumferential direction of the first body portion 3110 is 0.01-2.4 mm. If the width of the first pore portion 3101 is greater than 2.4 mm, when the first patch 3100 is assembled on the anvil 1200, the first pore portion 3101 may cover the anvil groove 1212 of the anvil end face 1210. When the stapler is fired, the staple may damage the structure of the first pore portion 3101. If the width of the first pore portion 3101 is less than 0.01 mm, after the stapler is fired, because the first pore portion 3101 is too small, the fluid resistance at the location of the first pore portion 3101 may be large when the fluid passes through the anastomosis, which may easily lead to uneven flow or local embolism.
[0074] In some embodiments, the first body portion 3110 further includes one or more first positioning holes 3103, which are disposed through the first body portion 3110 and configured to accurately install the first patch 3100 onto the anvil 1200. Correspondingly, the anvil end face 1210 is provided with a first positioning post 1211, configured to connect with the first positioning hole 3103, so that the first patch 3100 is accurately assembled onto the anvil 1200, thereby achieving accurate positioning of the first patch 3100 and the anvil end face 1210.
[0075] In some embodiments, the anvil end face 1210 is provided with a first positioning post 1211, and one or more first positioning posts 1211 may be provided, configured to be stably connected to the fixed patch 3000.
[0076] In some embodiments, when there is one first positioning hole 3103, there is also one first positioning post 1211 at the anvil end face 1210. The cooperation between the first positioning hole 3103 and the first positioning post 1211 ensures a single engagement between the fixing patch 3000 and the anvil assembly 1000. This is because the anvil assembly 1000 is provided with multiple staples, and the single engagement ensures that the first hole 3101 will not cover the staples.
[0077] In some embodiments, when there are multiple first positioning holes 3103, there are also multiple first positioning posts 1211 at the anvil end face 1210. Through a specific configuration of the multiple first positioning holes 3103 and multiple first positioning posts 1211, a single engagement method is achieved between the fixing patch 3000 and the anvil assembly 1000. For example, in some embodiments, when the multiple first positioning holes 3103 are on the same circumference, the multiple first positioning holes 3103 are arranged with uneven spacing on the circumference, and the first positioning posts 1211 are also arranged in the same manner, so that a single engagement method is achieved between the fixing patch 3000 and the anvil assembly 1000, and the circumference is concentric with the first cutting position 3102. In other embodiments, when the plurality of first positioning holes 3103 are located on a plurality of circumferences, the first positioning post 1211 is also configured in the same manner, such that there is a single engagement between the fixing patch 3000 and the anvil assembly 1000, the circumferences being concentric with the first cutting position 3102, and the plurality of circumferences being concentric with the first cutting position 3102.
[0078] In other embodiments, when the plurality of first positioning holes 3103 are configured in a random manner, the first positioning post 1211 is also configured in the same manner, so that there is a single engagement method between the fixing patch 3000 and the anvil assembly 1000.
[0079] In other embodiments, the plurality of first positioning holes 3103 are not all the same in shape or size, and the first positioning post 1211 is also configured in the same way, so that there is a single engagement method between the fixing patch 3000 and the anvil assembly 1000.
[0080] In some embodiments, the height of the first positioning post 1211 is 0.1-1mm, preferably 0.2-0.5mm. If the height of the first positioning post 1211 is too large, the local clamping of the anastomosis may be too tight when the stapler clamps the anastomosis, and the pressure on the tissue around the anastomosis may be too great. In addition, it may also cause the stapler to loosen during the clamping process. If the height of the first positioning post 1211 is too small, the assembly of the first patch 3100 with the anvil 1200 may be difficult. In addition, it may also cause the fixed patch 3000 to shift during the clamping process.
[0081] In some embodiments, the first positioning hole 3103 is disposed between the second stapling portion 3132 and the outer ring edge, configured to increase the extension space of the first aperture portion 3101 in the axial direction of the first body portion 3110. The diameter of the first positioning hole 3103 is 0.2-2.4 mm. If the diameter of the first positioning hole 3103 is less than 0.2 mm, it is easy to encounter alignment problems during the assembly of the first patch 3100; if the diameter of the first positioning hole 3103 is greater than 2.4 mm, the excessively large diameter of the first positioning hole 3103 may affect the setting of the first aperture portion 3101 or affect the firing of the staples, thus failing to guarantee the normal operation of the stapler.
[0082] In this application, the biomaterial used in the first patch 3100 is selected from biodegradable polymer materials or biodegradable animal-derived biomaterials. Preferably, the biodegradable animal-derived biomaterials include dermal matrix, pericardium, peritoneum, bladder submucosa, or small intestinal submucosa treated with immunogen removal, or combinations of these materials, such as compositions obtained by lamination, weaving, or embedding. Preferably, it includes decellularized small intestinal submucosa matrix material. The biodegradable polymer material may be selected from PGA, PLA, or PLGA, or combinations of these materials, such as compositions obtained by lamination, weaving, or embedding.
[0083] In some embodiments, such as Figure 9As shown, the second patch 3200 includes a second body portion 3210 and a second connecting portion 3220. The second body portion 3210 covers the staple cartridge end face 2210, and the second connecting portion 3220 is perpendicular to the second body portion 3210 and is used to wrap around the outer edge of the staple cartridge 2100 to prevent the edge of the staple cartridge 2100 from directly contacting human tissue in actual application. The second body portion 3210 and the second connecting portion 3220 are integrally formed. The second patch 3200 has a second body portion 3210 and a second aperture portion 3201. A second positioning hole 3203 is provided through the surface of the second body portion 3210. A second positioning post 2211 is provided on the staple cartridge end face 2210 and configured to connect with the second positioning hole 3203 so that the second patch 3200 is accurately assembled into the staple cartridge 2100, achieving accurate positioning of the second patch 3200 and the staple cartridge end face 2210. The second body portion 3210 has the same shape and structure as the first body portion 3110; therefore, the shape, structure, and functional effects of the second body portion 3210 will not be described in detail here. Because the second body portion 3210 and the first body portion 3110 have the same shape and structure, when fluid passes through the interior of the fixed patch 3000, the first patch 3100 and the second patch 3200 exert the same hydrostatic pressure on the fluid.
[0084] The second patch 3200 is used in conjunction with the staple cartridge 2100 for assembly into a stapler to repair the anastomosis by firing the stapler. When the second patch 3200 is assembled into the staple cartridge 2100, the body of the second patch 3200 fits against the staple cartridge end face 2210 of the staple cartridge 2100, and the second connecting portion 3220 is sleeved on the side of the staple cartridge 2100, ensuring a stable connection between the second patch 3200 and the staple cartridge 2100. The second connecting portion 3220 also includes a second side slot 3204 for easy connection between the second patch 3200 and the staple cartridge 2100. Responding to the annular blade 2220 of the staple cartridge 2100, the second patch 3200 is cut along the second cutting position 3202. The inner ring edge of the second patch 3200 body is serrated. The cut second patch 3200 is as follows... Figure 10 As shown.
[0085] In some embodiments, such as Figure 5 As shown, the staple cartridge end face 2210 is provided with a second positioning post 2211. There may be one or more second positioning posts 2211, configured to be stably connected to the second patch 3200.
[0086] In some embodiments, when there is one second positioning hole 3203, there is also one second positioning post 2211 at the end face 2210 of the staple cartridge. The cooperation between the second positioning hole 3203 and the second positioning post 2211 ensures a single engagement between the second patch 3200 and the staple cartridge assembly 2000. This is because the staple cartridge assembly 2000 contains multiple staples, and this single engagement ensures that the second hole 3201 will not cover the staples.
[0087] In some embodiments, when there are multiple second positioning holes 3203, there are also multiple second positioning posts 2211 at the end face 2210 of the staple cartridge. Through the special configuration of the multiple second positioning holes 3203 and the multiple second positioning posts 2211, a single mating method is achieved between the second patch 3200 and the staple cartridge assembly 2000.
[0088] For example, in some embodiments, when the plurality of second positioning holes 3203 are on the same circumference, the plurality of second positioning holes 3203 are arranged in a non-uniformly spaced manner on the circumference, and the second positioning post 2211 is also arranged in the same manner, so that the second patch 3200 and the staple cartridge assembly 2000 have a single engagement method, and the circumference is concentric with the second cutting position 3202.
[0089] In other embodiments, when the plurality of second positioning holes 3203 are located on a plurality of circumferences, the second positioning post 2211 is also configured in the same manner, so that there is a single engagement between the second patch 3200 and the staple cartridge assembly 2000, wherein the circumferences are concentric with the second cutting position 3202, and the plurality of circumferences are concentric with the second cutting position 3202.
[0090] In some embodiments, when the plurality of second positioning holes 3203 are configured randomly, the second positioning post 2211 is also configured in the same manner, so that there is a single engagement method between the second patch 3200 and the staple cartridge assembly 2000. In other embodiments, the plurality of second positioning holes 3203 are not completely identical in shape or size, and the second positioning post 2211 is also configured in the same manner, so that there is a single engagement method between the second patch 3200 and the staple cartridge assembly 2000.
[0091] In some embodiments, the height of the second positioning post 2211 is 0.1-1mm, preferably 0.2-0.5mm. If the height of the second positioning post 2211 is too large, it may cause the local clamping of the anastomosis to be too tight when the stapler clamps the anastomosis, resulting in excessive compression of the tissue around the anastomosis. It may also cause the stapler to loosen during the clamping process. If the height of the second positioning post 2211 is too small, it may cause assembly difficulties when the anastomosis reinforcement patch is fitted to the staple cartridge 2100. In addition, it may also cause the fixed patch 3000 to shift during the clamping process.
[0092] In some embodiments, the stapler further includes a tubular connecting assembly 4000, which is connected to the staple cartridge assembly 2000. The tubular connecting assembly 4000 is externally provided with an elastic connector 4100, which can be a tubular structure with elasticity. Under its own elasticity, the elastic connector 4100 is tightly fitted to the tubular connecting assembly 4000 and configured to connect to the second patch 3200 under the action of external force, so that the second patch 3200 is fixed to the end of the staple cartridge 2100.
[0093] Specifically, the elastic connector 4100 is provided with a first connecting hole 4101; the second connecting portion 3220 of the second patch 3200 is provided with a second connecting hole 3221 through it. When the second patch 3200 is assembled into the staple cartridge 2100, the second body portion 3210 covers the staple cartridge end face 2210, and the second connecting portion 3220 covers at least part of the side wall of the staple cartridge 2100. At this time, a connecting wire 2400 can pass through the first connecting hole 4101 and the second connecting hole 3221 to connect the second patch 3200 with the elastic connector 4100, thereby realizing the assembly of the second patch 3200 with the staple cartridge 2100.
[0094] In some embodiments, the staple cartridge 2100 further includes a lead groove 2001, which is disposed on the outer wall of the staple cartridge 2100 and extends along the height direction of the staple cartridge 2100, configured to guide the connecting wire 2400. When the connecting wire 2400 connects the second patch 3200 to the elastic connector 4100, at least a portion of the middle part of the connecting wire 2400 passes through the interior of the lead groove 2001, preventing the connecting wire 2400 from wrapping around the staple cartridge 2100 or covering the end face 2210 of the staple cartridge. If the connecting wire 2400 covers the end face 2210 of the staple cartridge, after the stapler is fired, there will be excess connecting wire 2400 stapled on the anastomosis surface, which may obstruct the anastomosis and cause fluid flow obstruction at the anastomosis, which may lead to embolism and local tissue necrosis in severe cases.
[0095] In some embodiments, the connecting wire 2400 can be a single wire or a double wire. The type of connecting wire 2400 used and the connection method of the connecting wire 2400 do not affect the application of the staple cartridge assembly 2000 provided in this disclosure in the stapler, as long as the connecting wire 2400 does not wrap around the staple cartridge 2100 or cover the staple cartridge end face 2210.
[0096] In some embodiments, the anvil assembly 1000 and the staple cartridge assembly 2000 are detachably connected, having a detached state and an installed state. Specifically, in the installed state, the anvil assembly 1000 and the staple cartridge assembly 2000 have a first state and a second state. When the anvil assembly 1000 and the staple cartridge assembly 2000 are in the first state, the anvil 1200 is separated from the staple cartridge 2100, and the first patch 3100 and the second patch 3200 are separated, respectively assembled to the anvil 1200 and the staple cartridge 2100; when the anvil assembly 1000 and the staple cartridge assembly 2000 are in the second state, the anvil 1200 is attached to the staple cartridge 2100, and the first patch 3100 and the second patch 3200 are attached, and the staples in the staple cartridge 2100 will connect the first patch 3100 and the second patch 3200.
[0097] In some embodiments, such as Figure 11 As shown, the staple cartridge assembly 2000 also includes a shaft core 2300. The inner wall of the shaft core 2300 is provided with a third connecting part 2310 suitable for connection with the central shaft body. When the anvil assembly 1000 and the staple cartridge assembly 2000 switch from the first state to the second state, the central shaft body is connected to the third connecting part 2310.
[0098] Specifically, when the anvil assembly 1000 and the staple cartridge assembly 2000 are in the second state, the end of the central shaft body portion away from the staple cap 1100 extends into the staple cartridge 2100 and connects with the third connecting portion 2310 in the shaft core 2300, thereby making the anvil 1200 fit against the staple cartridge 2100.
[0099] In some embodiments, the annular blade 2220 of the staple cartridge 2100 is disposed outside the shaft core 2300 and moves along the length of the shaft core 2300. The annular blade 2220 has a storage position and a working position relative to the staple cartridge assembly 2000. When the anvil assembly 1000 and the staple cartridge assembly 2000 are in the installed state, the annular blade 2220 is stored inside the staple cartridge 2100, as shown below. Figure 11 As shown, the annular blade 2220 is in the retracted position at this time; when the anvil assembly 1000 and the staple cartridge assembly 2000 are in the second state, the stapler can be fired, causing the annular blade 2220 to switch from the retracted position to the working position. In the working position, the end of the annular blade 2220 extends out of the staple cartridge end face 2210 and cuts the first patch 3100 and the second patch 3200, so that part of the fixing patch 3000 is separated from the stapler.
[0100] In some embodiments, when the anastomosis device returns from the firing state to the installation state, the annular blade 2220 switches from the working position to the storage position. At this time, the first patch 3100 and the second patch 3200 are cut off by the annular blade 2220, and the cut-off portion is a circular structure or annular structure with serrated edges.
[0101] Specifically, since the first body part 3110 and the second patch 3200 are respectively provided with a first pore part 3101 and a second pore part 3201 on their body surfaces, and the first pore part 3101 and the second pore part 3201 overlap, when the annular blade 2220 cuts the first patch 3100 and the second patch 3200, the edges of the first pore part 3101 and the second pore part 3201 together with the first cutting position and the second cutting position form a tooth-like structure. When there is fluid flowing at the anastomosis, it can increase the fluid flow area, promote the fluid to be more evenly distributed in the annular space, avoid local flow velocity being too high or too low, make the fluid flow more stable and uniform across the entire cross section, help alleviate congestion, and avoid poor fluid flow at the anastomosis.
[0102] In some embodiments, the stapler further includes a grip 5000, which includes a firing handle 5100 and a safety pin 5200. When the anvil assembly 1000 and the staple cartridge assembly 2000 are in the second state, the stapler can be switched to the firing state. Before firing the stapler, the safety pin 5200 needs to be pulled away from the firing handle 5100. Furthermore, the firing handle 5100 is pressed down with full force, causing the staple cartridge 2100 to move towards the front end of the stapler as a whole, while simultaneously pushing out the staples and the circular blade 2220. The staple protrudes from the staple cartridge 2100 and penetrates the fixing patch 3000. The tip of the staple contacts and deforms with the anvil groove 1212 at the end of the anvil 1200, so that the first staple engagement portion 3131 and the second staple engagement portion 3132 of the first patch 3100 are connected and fixed to the second patch 3200. The ring cutter 2220 protrudes from the end face 2210 of the staple cartridge and cuts the first body portion 3110 and the body of the second patch 3200 along the first cutting position 3102 and the second cutting position 3202.
[0103] The specific structure, working principle, and beneficial effects of the stapler provided in this embodiment can be referred to the stapler described in any of the above embodiments, and will not be repeated here.
[0104] Finally, it should be noted that the various embodiments in this specification are described in a progressive manner, with each embodiment focusing on its differences from other embodiments. Similar or identical parts between embodiments can be referred to interchangeably. For the systems or apparatus disclosed in the embodiments, since they correspond to the methods disclosed in the embodiments, the descriptions are relatively simple, and relevant parts can be referred to the method section.
[0105] The above embodiments are only used to illustrate the technical solutions of this disclosure, and are not intended to limit it. Although this disclosure has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of this disclosure.
Claims
1. A stapler, characterized in that, Configurations to reduce fluid resistance at the anastomosis site include: An anvil assembly includes an anvil having an anvil end face; An staple cartridge assembly includes a staple cartridge and a ring blade, wherein the ring blade is movably disposed inside the staple cartridge, and the staple cartridge has a staple cartridge end face; A fixing patch, wherein the fixing patch has a ring structure, includes a first patch and a second patch. The first patch includes a first aperture and a first cut-out position, the first cut-out position penetrating the first aperture. The second patch includes a second aperture and a second cut-out position, the second cut-out position penetrating the second aperture. The stapler has an installed state and a firing state, and in response to the stapler being in the installed state, the anvil assembly is assembled to the staple cartridge assembly; In response to the stapler being in the firing state, the annular blade cuts the fixing patch along the first cutting position and the second cutting position. The annular structure inside the first cutting position and the second cutting position detaches from the fixing patch. The remaining portion of the first hole and the second hole forms an opening on one side facing the first cutting position or the second cutting position, configured to disperse the circumferential stress of the inner diameter of the first patch and the second patch.
2. The stapler according to claim 1, characterized in that, The first pore portion and the second pore portion have the same shape and size, and are configured to allow the fluid passing through the first patch and the second patch to have the same hydrostatic pressure.
3. The stapler according to claim 2, characterized in that, In the radial direction of the first patch, the first aperture has a first end adjacent to the inner ring and a second end adjacent to the outer ring, and the distance from the first cut position to the second end is greater than 1 / 2 of the distance from the first cut position to the edge of the outer ring.
4. The stapler according to claim 3, characterized in that, In the circumferential direction of the first patch, the width of the first pore is 0.01-2.4 mm.
5. The stapler according to claim 3, characterized in that, In the circumferential direction of the first patch, the width of the first end is smaller than the width of the second end.
6. The stapler according to claim 1, characterized in that, The anvil end face is provided with a first positioning post, and the staple cartridge end face is provided with a second positioning post, configured to ensure that the fixing patch is accurately assembled onto the anvil and / or the staple cartridge.
7. The stapler according to claim 6, characterized in that, In the axial direction of the stapler, the projections of the first positioning post and the second positioning post do not coincide, which is configured to reduce the gap between the anvil and the staple cartridge.
8. The stapler according to claim 1, characterized in that, The staple cartridge component includes: A connecting wire passes through the connecting hole of the second patch and is configured to connect the second patch to the staple cartridge.
9. The stapler according to claim 8, characterized in that, Also includes: A tubular connecting assembly is connected to the staple cartridge; An elastic connector, sleeved on the tubular connection assembly, is configured to connect to a second patch via a connecting line so that the second patch covers the end face of the staple cartridge.
10. The stapler according to claim 8, characterized in that, The staple cartridge also includes: A lead wire groove is provided on the outer wall of the staple cartridge, configured to prevent the connecting wire from getting tangled around the end face of the staple cartridge.