Skull base brain dura anastomosis device

Abstract

The present application relates to a surgical anastomosis apparatus, and specifically discloses a skull base brain dura mater anastomosis device, which comprises a tube group component, an anastomosis execution component, a handle operation component and a dura mater patch for anastomosis to an opening of skull base dura mater; the dura mater patch comprises a patch bottom wall and a patch side wall surrounding the patch bottom wall, and a front wall and a rear wall opposite to each other and an annular gap between the front wall and the rear wall are formed on the patch side wall by bending the patch side wall; the edges of the opening of the skull base dura mater are embedded into the annular gap by making the patch side wall pass through the opening of the skull base dura mater; the anastomosis execution component comprises a substrate component and a staple ejection mechanism, so that the substrate component is located at the rear side of the rear wall, the staple ejection mechanism is located at the front side of the front wall and is driven by the handle operation component to eject a staple to the front wall and make the staple pass through the front wall, the skull base dura mater of the opening edge, the rear wall in turn and nail the three of the front wall, the skull base dura mater and the rear wall through the stop of the substrate component.

Description

Technical Field

[0001] This invention relates to a surgical anastomosis device, and more particularly to a skull base dural anastomosis device. Background Technology

[0002] Transsphenoidal approach for skull base tumor resection is a typical minimally invasive surgical procedure for removing pituitary tumors in the sellar region of the skull base. The surgical approach involves passing through the nasal cavity, the anterior wall of the sphenoid sinus, and the posterior wall of the sphenoid sinus to directly reach the pituitary tumor in the sellar region. Because the approach passes almost no intracranial brain tissue, compared with traditional craniotomy, transsphenoidal approach for skull base tumor resection has the advantages of less damage to brain tissue, a lower probability of cerebral edema and cranial nerve injury, and a shorter postoperative recovery period.

[0003] The surgical procedure for transsphenoidal skull base tumor resection mainly includes the following steps: 1. Creating a surgical pathway: Specifically, bone-opening instruments such as drills and bone forceps are delivered through the nasal cavity to the anterior wall of the sphenoid sinus to remove the bone body of the anterior wall, thereby expanding the opening of the anterior wall of the sphenoid sinus. Then, the bone-opening instruments reach the posterior wall of the sphenoid sinus (or sella floor) through the opening of the anterior wall to create a bone window in the bone body of the posterior wall, thereby creating a linear surgical pathway for surgical instruments to reach the sellar region and exposing the dura mater of the skull base; 2. Making an incision in the dura mater of the skull base: Specifically, dura mater opening instruments such as scalpels or scissors are delivered through the nasal cavity and along the opened pathway to the posterior wall of the sphenoid sinus. 1. At the bone window of the sphenoid sinus wall, make an incision (e.g., a cross incision or a circular incision) on the dura mater of the skull base corresponding to the bone window to expose the brain tissue at the skull base; 2. Remove the pituitary tumor. Specifically, the surgical scalpel is delivered along the pathway through the bone window of the posterior wall of the sphenoid sinus and the incision of the dura mater at the skull base to the brain tissue at the skull base, and then the pituitary tumor is removed; 3. Close the dura mater incision at the skull base. Specifically, the dura mater patch (as an implant, which can be made of human absorbable material or of biocompatible non-absorbable material) is delivered to the incision site of the dura mater at the skull base, and then the dura mater at the skull base is attached to the incision site, and the dura mater patch is anastomosed with the dura mater at the skull base.

[0004] In the prior art, there are three typical methods for anastomosing a dural patch to the incision site of the dura mater at the base of the skull: 1. Adhere the dural patch to the dura mater at the base of the skull using adhesive to achieve anastomosis; 2. Suture the dural patch to the dura mater at the base of the skull using a stapler to achieve anastomosis; 3. Staple the dural patch to the dura mater at the base of the skull to achieve anastomosis.

[0005] The three anastomosis methods mentioned above all face challenges in terms of both anastomosis operation and anastomosis effect. Specifically, for anastomosis using adhesive bonding, the adhesive bonding is unreliable, and in the early postoperative period, adhesion failure may lead to displacement of the dural patch, resulting in a large amount of cerebrospinal fluid leakage through the dural incision. For anastomosis using sutures, on the one hand, the movement space of each actuator on the suture device is severely restricted by the small opening of the bone window on the posterior wall of the sphenoid sinus, significantly increasing the difficulty of suturing the non-sellar dura mater compared to traditional craniotomy. On the other hand, the area between each adjacent suture is poorly sealed, mainly because the edge of the dural patch is only overlapped or butted with the boundary of the skull base dura mater. For anastomosis using staples, one... On the one hand, because the two clamping parts of the stapler (one clamping part is the backing part and the other clamping part is the pressure part) are blocked by the dural patch, they cannot staple the overlapping area of ​​the edge of the dural patch and the edge of the dural base in a manner located on both sides of the dural base. Therefore, the staples can only be stapled by squeezing out folds or forming flanges on the outer side of the dural patch and the outer side of the dural base, and then stapled through the folds or flanges. However, because there is a large tension in the dural base, it is difficult to form folds or flanges on the dural base, which increases the difficulty of the stapled operation. On the other hand, the area between the two staples also has the defect of poor sealing due to the same reasons as the suturing method. Summary of the Invention

[0006] To address the aforementioned technical problems in the prior art, the present invention provides a skull base dura mater anastomosis device.

[0007] To solve the above-mentioned technical problems, the technical solution adopted by the present invention is as follows:

[0008] A skull base dural anastomosis device includes: a tubular assembly having a distal end and a proximal end; an anastomosis execution component attached to the distal end of the tubular assembly; a handle operating component attached to the proximal end of the tubular assembly for driving the anastomosis execution component to perform anastomosis actions via the tubular assembly; and a dural patch detachably attached to the anastomosis execution component for anastomosing to an opening in the skull base dura mater; wherein:

[0009] The dural patch includes a patch base wall and patch sidewalls surrounding the patch base wall. By bending the patch sidewalls, an anterior wall and a posterior wall opposite to each other and an annular gap between them are formed on them. By making the patch sidewalls pass through the opening of the dura mater at the base of the skull, the edge of the opening is radially embedded into the annular gap and between the anterior wall and the posterior wall.

[0010] The anastomosis execution component includes at least a substrate component and a staple ejection mechanism, such that the substrate component is located on the rear side of the posterior wall, and the staple ejection mechanism is located on the front side of the anterior wall and is driven by a handle operation component to eject staples from the anterior wall, such that the staples sequentially pass through the anterior wall, the dura mater at the opening edge of the skull base, and the posterior wall, and are stapled together by the stop of the substrate component.

[0011] Preferably, the matching execution component further includes a guide sleeve and a driven inner tube; the staple ejection mechanism is located radially outside the guide sleeve and can simultaneously eject multiple circumferentially arranged staples; the driven inner tube is located radially inside the guide sleeve and can move axially relative to the guide sleeve; wherein:

[0012] The substrate component includes a plurality of circumferentially arranged plate-shaped substrate units integrally formed on the tube wall of the port of the driven inner tube. The plurality of substrate units correspond to the circumferential positions of the staples being ejected. The substrate units are radially contracted by elastic deformation and are elastically restored to a state perpendicular to the axis of the driven inner tube. Thus, when the driven inner tube is driven by the handle operating component to move towards the proximal end and apply a pulling force to the radially inward side of the substrate unit, the port of the guide sleeve forces the substrate unit to contract radially. When the driven inner tube is released, the substrate unit automatically elastically restores to the unfolded state to stop the staples.

[0013] Preferably, the nail-dispensing mechanism includes:

[0014] The staple ejector sleeve is fitted outside the guide sleeve. The staple ejector sleeve has a staple ejector end face facing the front wall of the dura mater and a stepped surface facing the opposite direction to the staple ejector end face. Multiple staple ejector cavities are provided on the sleeve wall between the staple ejector end face and the stepped surface, and the staples are placed in the staple ejector cavities.

[0015] The nail-pushing component includes a force-applying ring axially opposite to the stepped surface of the nail-dispensing sleeve and movable relative to the nail-dispensing sleeve, and push rods circumferentially arranged on the force-applying ring and extending from one side of the stepped surface into the bottom of the nail-dispensing cavity; wherein:

[0016] The force ring is driven by the handle operating component, causing multiple push rods to push the staples in the staple cavity synchronously out of the staple ejection end face and through the anterior wall, the dura mater of the skull base at the opening edge, and the posterior wall.

[0017] Preferably, the stud ejector sleeve is configured to be axially movable relative to the guide sleeve such that: before ejecting the stud, the stud ejector sleeve is driven by the handle operating component to move axially relative to the guide sleeve to apply pressure to the front wall of the dura mater patch.

[0018] Preferably, the front wall of the hard membrane patch is separably attached to the nail ejector end face of the nail ejector sleeve through a plurality of circumferentially arranged adhesive areas.

[0019] Preferably, the staple includes a columnar segment with a radially protruding extension piece at its tail. The staple cavity includes a main cavity for accommodating the columnar segment and a wing cavity surrounding the main cavity for accommodating the extension piece. The head of the columnar segment has an expandable portion, which includes a staple head, a plurality of elastic lines circumferentially arranged between the staple head and the columnar segment, a backstop hole in the columnar segment, and a backstop extending from the staple head toward the backstop hole with barbs on its outer peripheral surface. After the staple head passes through the rear wall of the hard film patch and contacts the substrate unit, the substrate unit pushes the staple head in the opposite direction to cause the expandable portion to expand radially and insert the backstop into the backstop hole so that the expandable portion remains in an expanded state.

[0020] Preferably, each substrate unit of the substrate component has a recessed groove at the circumferential position corresponding to the staple, and the recessed groove extends radially and penetrates to the outer edge of the substrate unit.

[0021] Preferably, the rotation of the driven inner tube relative to the guide sleeve is restricted, and the rotation of the nail-spitting sleeve relative to the guide sleeve is also restricted.

[0022] Preferably, the handle operating component includes:

[0023] The main tube is connected to the guide sleeve via tube assembly components;

[0024] The force-applying inner tube is disposed in the main tube and connected to the driven inner tube through the tube assembly to drive the driven inner tube, and the tail of the force-applying inner tube extends out of the tail of the main tube.

[0025] The first threaded sleeve is screwed onto the tail of the main tube. The tail of the first threaded sleeve is connected to the tail of the force-applying inner tube. By screwing the first threaded sleeve, the force-applying inner tube is driven to move axially relative to the main tube.

[0026] The first force-applying outer tube is sleeved outside the main tube and connected to the nail-spitting sleeve through the tube assembly to drive the nail-spitting sleeve. The main tube extends out of the tail of the first force-applying outer tube.

[0027] The second threaded sleeve is screwed onto the tail of the first force-applying outer tube. The tail of the second threaded sleeve is connected to the main tube. By screwing the second threaded sleeve, the first force-applying outer tube is driven to move axially relative to the main tube.

[0028] The second force-applying outer tube is sleeved outside the first force-applying outer tube and connected to the force-applying ring through the tube assembly to drive the force-applying ring.

[0029] The force-applying holding component includes two components, which are respectively mounted on the first force-applying outer tube and the second force-applying outer tube. By simultaneously applying an axial force to the two force-applying holding components, the second force-applying outer tube moves axially toward the distal end relative to the first force-applying outer tube to drive the pusher component to perform a pusher action.

[0030] Preferably, the second force-applying outer tube has a clearance window on its tube wall, one force-applying holding component is attached to the tube wall of the second force-applying outer tube, and the other force-applying holding component is attached to the first force-applying outer tube through the clearance window. The force-applying holding component attached to the second force-applying outer tube is closer to the tail of the first force-applying outer tube than the force-applying holding component attached to the first force-applying outer tube.

[0031] Preferably, a handle for human hand gripping is provided on the main body tube between the first threaded sleeve and the second threaded sleeve.

[0032] Compared with the prior art, the beneficial effects of the skull base dura mater anastomosis device disclosed in this invention are:

[0033] 1. The advantages of the anastomosis device provided by the present invention are as follows: On the one hand, by configuring a patch sidewall on the dural patch and forming an annular gap between a front wall, a rear wall, and an opening edge before stapling, a favorable shape is constructed in which the dural patch can be stapled to the dura mater of the skull base simply by placing the substrate component behind the rear wall of the patch sidewall without having the substrate component go around to the rear side of the dural patch (specifically, the rear side of the rear wall of the patch); on the other hand, the edge of the opening is between the front wall and the rear wall constructed on the patch sidewall, thereby significantly improving the connection and sealing effect between the dural patch and the dura mater of the skull base, thereby significantly reducing the risk of cerebrospinal fluid leakage between the dural patch and the dura mater of the skull base.

[0034] 2. Other advantages of the present invention are described directly or implicitly in the specific embodiments of the specification.

[0035] The overview of various implementations or examples of the technology described in this invention is not a complete disclosure of the full scope or all features of the disclosed technology. Attached Figure Description

[0036] In drawings that are not necessarily drawn to scale, the same reference numerals may describe similar parts in different views. The same reference numerals with or without letter suffixes may indicate different instances of similar parts. The drawings generally illustrate various embodiments by way of example rather than limitation and, together with the description and claims, serve to explain embodiments of the invention. Where appropriate, the same reference numerals are used in all drawings to refer to the same or similar parts. Such embodiments are illustrative and not intended to be exhaustive or exclusive embodiments of the apparatus or method.

[0037] Figure 1 A state view of the anastomosis device provided in an embodiment of the present invention delivering a dural patch via the nose to the opening of the dural at the base of the skull in the sellar region.

[0038] Figure 2 A three-dimensional structural schematic diagram of the anastomosis device provided for an embodiment of the present invention (the substrate component is in a contracted state).

[0039] Figure 3 A three-dimensional structural diagram of the matching actuator (the substrate component is in an expanded state).

[0040] Figure 4 A dura mater patch with a structure present in a free state, provided as an embodiment of the present invention.

[0041] Figure 5 This is an embodiment of the present invention, showing an alternative structure of the dura mater patch in its free state.

[0042] Figure 6 A main cross-sectional view of the anastomosis device provided for an embodiment of the present invention (the substrate component is in a contracted state).

[0043] Figure 7 To match the main cross-sectional view of the actuator (the substrate component is in an expanded state).

[0044] Figure 8 This is a three-dimensional structural diagram of a staple (the staple is in a retracted state).

[0045] Figure 9 This is a front sectional view of the staples (the staples are in an expanded state).

[0046] Figure 10 A first operational state view of the anastomosis device when performing anastomosis operations.

[0047] Figure 11 A second operational state view of the anastomosis device when performing anastomosis operations.

[0048] Figure 12This is a third operational state view of the anastomosis device when performing anastomosis operations.

[0049] Figure 13 This is the fourth operating state view of the anastomosis device when performing anastomosis operations.

[0050] Figure 14 A view of the dural patch after the anastomosis procedure has been completed.

[0051] Figure label:

[0052] 100-Matching device; 10-Matching execution component; 11-Substrate component; 111-Substrate unit; 112-Counterpart; 113-Notch; 12-Driven inner tube; 121-First keyway; 122-First guide key; 13-Guide sleeve; 131-Second keyway; 132-Second guide key; 14-Protective sleeve; 20-Nail ejection mechanism; 21-Nail ejection sleeve; 211-Nail ejection end face; 212-Stepped surface; 213-Nail ejection cavity; 2131-Main body cavity; 2132-Wing cavity; 214-Glue container; 22-Nail pusher component; 221-Force ring; 222-Push rod; 223-Spring; 23-Staple; 231-Columnar segment; 232-Extension sheet; 233-Expandable part; 2331 - Elastic line; 234- Nail head; 235- Anti-reverse bolt; 236- Anti-reverse hole; 30- Handle operating component; 31- Force-applying inner tube; 32- Main tube; 321- Handle; 33- First force-applying outer tube; 34- Second force-applying outer tube; 35- First threaded sleeve; 351- First retaining ring; 36- Second threaded sleeve; 361- Second retaining ring; 371- First force-applying holding component; 372- Second force-applying holding component; 40- Tube assembly component; 41- Intermediate inner tube; 42- Intermediate main tube; 43- First intermediate outer tube; 44- Second intermediate outer tube; 50- Hard membrane patch; 51- Patch rear wall; 52- Patch side wall; 521- Front wall; 522- Rear wall; 523- Annular gap; 524- Circular protrusion.

[0053] 200 - Dura mater at the base of the skull; 201 - Opening; 202 - Margin; 300 - Posterior wall of the sphenoid sinus; 301 - Bone window; 400 - Anterior wall of the sphenoid sinus. Detailed Implementation

[0054] Unless otherwise defined, the technical or scientific terms used in this invention shall have the ordinary meaning understood by one of ordinary skill in the art to which this invention pertains. The terms "first," "second," and similar terms used in this invention do not indicate any order, quantity, or importance, but are merely used to distinguish different components. Terms such as "comprising" or "including" mean that the element or object preceding the word encompasses the elements or objects listed following the word and their equivalents, without excluding other elements or objects. Terms such as "connected" or "linked" are not limited to physical or mechanical connections, but can include electrical connections, whether direct or indirect. Terms such as "upper," "lower," "left," and "right" are used only to indicate relative positional relationships; when the absolute position of the described object changes, the relative positional relationship may also change accordingly.

[0055] To keep the following description of the embodiments of the present invention clear and concise, detailed descriptions of known functions and known components are omitted.

[0056] This invention addresses two aspects: firstly, by providing a dural patch 50 for closing the opening 201 of the dura mater 200 at the sellar region during transsphenoidal skull base tumor resection; and secondly, by providing an anastomosis device for delivering the dural patch 50 to the opening 201 of the dura mater 200 and anastomosing the dural patch 50 to the opening 201 to achieve closure of the dura mater 200 during transsphenoidal skull base tumor resection. The dural patch 50 and the anastomosis device may be collectively referred to as an anastomosis device 100. The anastomosis device 100 provided by this invention anastomoses the dural patch 50 to the opening 201 of the dura mater 200 at the skull base using a stapled method.

[0057] like Figures 1 to 7As shown, the anastomosis device 100 provided by the present invention includes: a dural patch 50, a tube assembly 40, an anastomosis execution component 10, and a handle operating component 30. The dural patch 50 is an implantable component for anastomosing to the opening 201 of the dura mater 200 at the base of the skull to close the opening 201; the anastomosis execution component 10 is an execution component for anastomosing the dural patch 50 to the opening 201 of the dura mater 200 at the base of the skull by stapling; the handle operating component 30 is a driving component for a physician to hold and operate to drive the anastomosis execution component 10 to perform the anastomosis action; the tube assembly 40 has a linear and slender shape, the anastomosis execution component 10 is attached to the distal end of the tube assembly 40, the handle operating component 30 is attached to the proximal end of the tube assembly 40, and the dural patch 50 is detachably attached to the end of the anastomosis execution component 10. During the closure of the opening 201 of the dura mater 200 at the skull base during transsphenoidal skull base tumor resection, the surgeon, holding the handle operating component 30, delivers the anastomosis execution component 10 and the attached dura mater patch 50 through the tube assembly component 40 via the nasal cavity, the window of the anterior wall 400 of the sphenoid sinus, and the bone window 301 of the posterior wall 300 of the sphenoid sinus to the opening 201 of the dura mater 200. Simultaneously, after delivering the anastomosis execution component 10 and the attached dura mater patch 50 to the opening 201, the surgeon operates the handle operating component 30 and transmits power to the anastomosis execution component 10 via the tube assembly component 40. Therefore, the tube assembly component 40 serves both as a delivery device and a transmission device. Preferably, the tube assembly component 40 transmits multiple powers from the handle operating component 30 to the anastomosis execution component 10 independently through multiple nested tubular components.

[0058] like Figure 14 As shown, the dural patch 50 is an implant used for anastomosis to the opening 201 of the dura mater 200 at the base of the skull. The dural patch 50 can be made of absorbable material or non-absorbable material with good biocompatibility, such as absorbable material with collagen as a matrix, absorbable material such as polylactic-co-glycolic acid copolymer (PLGA), or non-absorbable material such as silicone. In this invention, as... Figure 4 and Figure 5 As shown, the dura mater patch 50 is configured to have a patch bottom wall and patch sidewalls 52 that surround and are integrally formed with the patch bottom wall. During the anastomosis operation, as... Figure 14 As shown, the sidewall 52 of the patch is responsible for stapling to the edge 202 of the opening 201 of the dura mater 200 at the skull base, while the bottom wall of the patch does not participate in the stapling of the dura mater 200 at the skull base. Furthermore, before stapling, as... Figure 7 and Figure 12As shown, by bending the patch sidewall 52 of the dural patch 50, an anterior wall 521 and a posterior wall 522 that are axially opposite each other and an annular gap 523 that is radially open and radially closed between the anterior wall 521 and the posterior wall 522 is obtained on the patch sidewall 52. Thus, if the patch sidewall 52 is made to penetrate the opening 201 of the skull base dural 200 and remain in the penetrated state, the edge 202 of the opening 201 can be embedded from the radially outer side into the annular gap 523 constructed on the patch sidewall 52 and between the anterior wall 521 and the posterior wall 522 constructed on the patch sidewall 52. This structure in which the edge 202 of the opening 201 is embedded between the anterior wall 521 and the posterior wall 522 provides favorable conditions for stapling.

[0059] like Figure 4 As shown, the curved shape formed on the patch sidewall 52, with an anterior wall 521, a rear wall 522, and an annular gap 523, can be constructed during the fabrication of the dura mater patch 50, or it can be formed by the support provided by the relevant components of the anastomosis execution member 10 to the patch sidewall 52 when the dura mater patch 50 is attached to the end face of the anastomosis execution member 10, forcing the patch sidewall 52 to bend. Alternatively, it can be formed by the movement of the relevant components of the anastomosis execution member 10 during the anastomosis step in surgery, forcing the patch sidewall 52 to bend and deform. For example, as... Figure 5 As shown, when fabricating the hard membrane patch 50, only an outward flange needs to be formed at the end of the patch sidewall 52. This outward flange is used to be separably attached to the end face of the head of the anastomosis execution member 10 using an adhesive. This outward flange serves as the front wall 521, while the rear wall 522 is formed by the radial static support generated by the related components of the anastomosis execution member 10 (e.g., the substrate component 11) on the inner side of the patch sidewall 52 near the bottom wall of the patch, which forces the patch sidewall 52 to bend, or by the radial expansion action of the related components during anastomosis, which dynamically forces the patch sidewall 52 to bend.

[0060] The anastomosis execution component 10, on the one hand, allows for the detachable attachment of the patch sidewall 52, and on the other hand, through the tube assembly component 40 driven by the handle operating component 30, performs the action of anastomosing the dural patch 50 to the opening 201 of the dura mater 200 at the base of the skull in a stapling manner. Figure 6 and Figure 7As shown, the mating execution component 10 includes at least a substrate component 11 and a staple ejection mechanism 20; a staple ejection end face 211 is disposed at the head of the staple ejection mechanism 20, such that a plurality of staples 23 arranged circumferentially in the staple ejection mechanism 20 are simultaneously ejected from the staple ejection end face 211; the outward flange of the patch sidewall 52 of the hard film patch 50, which serves as the front wall 521, is separably bonded to the staple ejection end face 211 by adhesives arranged circumferentially on multiple areas of the staple ejection end face 211; during mating, the substrate component 11 is located behind the staple ejection end face 211 and is axially opposite to the staple ejection end face 211 and is located within the space enclosed by the sidewall of the hard film patch 50, as shown. Figure 13 As shown, the substrate component 11 is used to stop the ejected staples 23, thereby deforming the staples 23 by means of the reaction force generated by the stop to achieve fastening. During fastening, the substrate component 11 is located behind the rear wall 522, and the staple ejection end face 211 is located in front of the front wall 521. Therefore, the staples 23 ejected from the staple ejection end face 211 sequentially pass through the front wall 521, the annular space between the front wall 521 and the rear wall 522, and the rear wall 522. For hard film patches 50 whose front wall 521 and rear wall 522 are already formed during manufacturing, the substrate component 11 is only used to hold them behind the rear wall 522. For hard film patches 50 whose rear wall 522 is not formed during manufacturing, the substrate component 11 is also used to force the sidewalls to bend and deform to obtain the rear wall 522. The substrate component 11 can be a disc-shaped component with non-expandable radial dimensions, or a disc-like component with expandable radial dimensions.

[0061] When performing a matching operation, such as Figure 12 As shown, the dural patch 50 is delivered to the position where its bottom wall passes through the opening 201 and is located posterior to the dural base 200, with its sidewall 52 precisely passing through the opening 201. Thus, the edge 202 of the opening 201 is radially outwardly embedded into the annular gap 523, situated between the anterior wall 521 and the posterior wall 522 of the sidewall 52. Thus, as... Figure 13 As shown, the staples 23 that are synchronously ejected from the staple ejection end face 211 of the staple ejection mechanism 20 can sequentially pass through the anterior wall 521, the edge 202 of the opening 201, and the posterior wall 522 to staple the three together, thereby fitting the dural patch 50 to the opening 201 of the dural 200 at the base of the skull.

[0062] The advantages of the anastomosis device 100 provided by the present invention are as follows: On the one hand, by configuring a patch sidewall 52 on the dural patch 50 and forming a front wall 521, a rear wall 522, and an annular gap 523 between the two for the edge 202 of the opening 201 to be inserted on the patch sidewall 52 before stapling, a favorable shape is constructed in which the dural patch 50 can be stapled to the dural base 200 simply by placing the substrate member 11 behind the rear wall 522 of the patch sidewall 52 without having the substrate member 11 go around to the rear side of the dural patch 50 (specifically, behind the rear wall 522 51 of the patch); on the other hand, the edge 202 of the opening 201 is between the front wall 521 and the rear wall 522 constructed on the patch sidewall 52, thereby significantly improving the connection and sealing effect between the dural patch 50 and the dural base 200, thereby significantly reducing the risk of cerebrospinal fluid leakage between the dural patch 50 and the dural base 200.

[0063] In some preferred configurations, the substrate component 11 is configured to be capable of radial expansion and radial contraction, for which, as shown below... Figure 6 and Figure 7 and combined Figure 2 and Figure 3 As shown, the matching execution component 10 also includes a guide sleeve 13 and a driven inner tube 12. The driven inner tube 12 is located radially inside the guide sleeve 13 and is axially movable relative to the guide sleeve 13. The distal end of the driven inner tube 12 is adjacent to the distal end of the guide sleeve 13. The rotation of the driven inner tube 12 relative to the guide sleeve 13 is restricted by the engagement of an axially extending first keyway 121 disposed on the inner wall of the guide sleeve 13 and an axially extending first guide key 122 disposed on the outer wall of the driven inner tube 12. Furthermore, the driven inner tube 12 is driven axially by the handle operation component 30 by the corresponding tube body of the tube assembly component 40. The substrate component 11 includes a plurality of plate-shaped substrate units 111 integrally formed on the wall of the distal end of the driven inner tube 12 and arranged circumferentially. A notch 113 is machined on the outer side of the junction area between each substrate unit 111 and the driven inner tube 12, making this junction area a deformable region. This allows the substrate unit 111 as a whole to deform radially inward. Furthermore, as... Figure 7 As shown, in a free state without being subjected to any related forces, the substrate unit 111 is in a state perpendicular to the axis of the driven inner tube 12. Thus, the substrate component 11 is in a radially expanded unfolded state as a whole, and all substrate units 111 are in the same plane. The substrate component 11 is equivalent to a disk-shaped component.

[0064] Before the dural patch 50 attached to the anastomosis execution component 10 is delivered through the created channel to the opening 201 of the dura mater 200 at the base of the skull, as Figure 6As shown, the driven inner tube 12 is driven axially relative to the guide sleeve 13 in the proximal direction by the handle operating component 30 via the tube assembly component 40. This causes the driven inner tube 12 to apply a pulling force to the radially inner side of all the substrate units 111 in the unfolded state. As a result, all the substrate units 111 are switched to the contracted state by the closing action of the port of the guide sleeve 13. This reduces the radial dimension occupied by the substrate components 11, allowing the anastomosis execution component 10 and the dural patch 50 to be delivered more smoothly to the opening 201 of the dura mater 200 at the base of the skull in the sellar region, avoiding interference with bone tissue such as the posterior wall 300 of the sphenoid sinus. Figure 11 As shown, and particularly advantageously, the substrate component 11 in its retracted state allows the hard film patch 50 to smoothly pass through the opening 201 by deformation or in its retracted state. Figure 7 and combined Figure 12 As shown, after the opening 201 is made through the side wall of the hard film patch 50, the driven inner tube 12 is driven to move toward the distal end relative to the guide sleeve 13 by the handle operating component 30, so that the distal port of the guide sleeve 13 releases the substrate unit 111. The substrate unit 111 is switched to a state perpendicular to the axis of the driven inner tube 12 by elastic reset. Thus, the substrate component 11 moves to the rear side of the rear wall 522 of the patch side wall 52, and the circumferential position of each substrate unit 111 corresponds to the stapling area of ​​the stapling end face 211 to respectively stop the stapling 23 that needs to be ejected in the subsequent steps.

[0065] In some preferred structures, such as Figure 5 As shown, the hard film patch 50 is configured in a radially contracted state in its free state to adapt to the aforementioned substrate component 11 capable of contraction and expansion. Specifically, the bottom wall of the hard film patch 50 forms a conical or arc-shaped structure, and the main body of the patch sidewall 52, excluding the flange, forms a conical wall structure adapted to the inclined state of the substrate unit 111 of the substrate component 11 in its contracted state. Thus, as... Figure 6 and combined Figure 10 , Figure 11 As shown, after the dural patch 50 is attached to the screw delivery end face 211 of the anastomosis execution component 10, both the dural patch 50 and the substrate component 11 are in a uniformly contracted state to facilitate smooth delivery to and through the opening 201 of the dural 200 at the base of the skull. After the patch sidewall 52 of the dural patch 50 passes through the opening 201 and the substrate component 11 expands radially, as... Figure 12As shown, each substrate unit 111 of the substrate component 11 forces the patch sidewall 52 to bend and form the rear wall 522, while also causing the patch rear wall 52251 to unfold due to the stretching caused by the deformation of the patch sidewall 52. Because the dural patch 50 is in a contracted state when passing through the opening 201, it does not need to be forced to switch to a contracted state by deformation due to the opening 201, thereby allowing the dural patch 50 to pass through the opening 201 of the skull base dural 200 more smoothly.

[0066] like Figure 6 and Figure 7As shown, the nail ejection mechanism 20 includes a nail ejection sleeve 21 and a nail pusher 22. The nail ejection sleeve 21 is sleeved outside the guide sleeve 13 and can move axially relative to the guide sleeve 13. The rotation of the nail ejection sleeve 21 relative to the guide sleeve 13 is restricted by a second keyway 131 disposed on the outer wall of the guide sleeve 13 and a second guide key 132 disposed on the inner wall of the nail ejection sleeve 21. The head end face of the nail ejection sleeve 21 is formed as a nail ejection end face 211. A stepped surface 212 facing opposite to the nail ejection end face 211 is also formed on the nail ejection sleeve 21. A plurality of axially penetrating and circumferentially arranged nail ejection parts are formed on the sleeve wall between the nail ejection end face 211 and the stepped surface 212. Each of the several staple ejection chambers 213 is equipped with a staple 23. The staple 23 can move along the staple ejection chamber 213 toward the staple ejection end face 211 and finally be ejected from the staple ejection end face 211. The multiple staple ejection chambers 213 are respectively opposite to the multiple substrate units 111 of the substrate component 11 in the expanded state so that the ejected staple 23 can be stopped by the corresponding substrate unit 111. The keyway and guide key mentioned above are used to limit the staple ejection sleeve 21 from being circumferentially misaligned with the staple ejection chamber 213 and the substrate unit 111 due to rotation. The pusher unit 22 includes a force-applying ring 221 sleeved on the outside of the nail-dispensing sleeve 21 and axially movable relative to the nail-dispensing sleeve 21, facing the stepped surface 212 of the nail-dispensing sleeve 21 and moving closer to or further away from the stepped surface 212 of the nail-dispensing sleeve 21 by axial movement, and a plurality of push rods 222 circumferentially arranged on the force-applying ring 221. The heads of the plurality of push rods 222 are pre-aligned with the stepped surface 212 and extend into the bottom of the nail-dispensing cavity 213. The force-applying ring 221 is driven by the handle operating component 30 via the tube assembly 40. This causes the force ring 221 to drive each push rod 222 to push each staple 23 towards the staple end face 211 in a synchronized manner, and causes each staple 23 to be ejected from the staple end face 211 to sequentially pass through the front wall 521 of the dura mater patch 50, the edge 202 of the opening 201 of the skull base dura mater 200 embedded in the annular gap 523, and the rear wall 522. The front wall 521, the edge 202 of the opening 201, and the rear wall 522 are deformed by the stop of the substrate unit 111 to achieve the fastening of the front wall 521, the edge 202 of the opening 201, and the rear wall 522. In addition, the staple ejector sleeve 21 is also driven by the handle operating component 30 through the tube assembly component 40. Thus, after the edge 202 of the opening 201 is embedded between the front wall 521 and the rear wall 522 of the patch sidewall 52 of the hard film patch 50 and before the staple is ejected, the handle operating component 30 drives the guide sleeve 13 to move towards the proximal end, so that the staple ejector end face 211 of the guide sleeve 13 applies pressure to the front wall 521, the edge 202 of the opening 201, and the rear wall 522 to clamp the three, thereby facilitating the smooth insertion of the staple 23 into the three and making the sealing effect after stapled better.

[0067] In some preferred configurations, a spring 223 is provided between the stepped surface 212 of the guide sleeve 13 and the force-applying ring 221 of the pusher part 22, so that the pusher part 22 automatically returns to its original position after performing the pusher action. In some more preferred configurations, such as... Figure 3 As shown, a flexible protective sleeve 14 (e.g., a corrugated sleeve 14) is provided over the area between the force ring 221 and the stepped surface 212 to shield components and structures such as push rod 222 and spring 223 in this area, so as to avoid these components and structures damaging the relevant tissues around the channel during the delivery of the matching execution component 10.

[0068] Various existing staple structures 23 can be used as staples 23 in the mating device 100, such as Figure 8 , Figure 9 and combined Figure 7 As shown, the present invention provides a staple 23 with the following structure: the staple 23 includes a columnar segment 231, a plurality of extension pieces 232 formed at the tail of the columnar segment 231 and arranged radially and circumferentially, a staple head 234 formed at the head of the columnar segment 231, an expandable portion 233 between the staple head 234 and the columnar segment 231 surrounded by a plurality of elastic lines 2331 that can be elastically deformed, a backstop hole 236 with barbs on the hole wall opened from the end face of the columnar segment 231, and a backstop post 235 extending from the staple head 234 toward the backstop hole 236 and having barbs on its outer peripheral surface. Correspondingly, the staple cavity includes a main cavity 2131 for accommodating the columnar segment 231 and a wing cavity 2132 surrounding the main cavity 2131 for accommodating the extension pieces 232. Before the staple 23 is located in the staple cavity and is pushed by the push rod 222, the expandable part 233 is in a contracted state, such as Figure 13As shown, after the staple 23 is pushed by the push rod 222 and ejected from the staple end face 211, it sequentially passes through the front wall 521 of the hard film patch 50, the edge 202 of the opening 201, and the rear wall 522 of the hard film patch 50, and is stopped by the corresponding substrate unit 111, the reaction force of the substrate unit 111 on the staple head 234 forces each elastic line 2331 of the expandable part 233 to expand radially and contract axially, while the anti-stop post 235... The staple 23 is inserted to the bottom of the anti-retraction hole 236 and is restricted from exiting in the opposite direction from the anti-retraction hole 236, thereby keeping the expandable part 233 in an expanded state. The expanded expandable part 233 abuts against the rear surface of the rear wall 522 to restrict the head of the staple 23 from exiting, while the tail of the staple 23 is restricted from exiting due to the extension piece 232, thereby anchoring the front wall 521, the edge 202 of the opening 201, and the rear wall 522 together as if anchored. The advantages of the staple 23 with the above structure are as follows: the staple 23 is an axially extending component with a large length-to-diameter ratio. The staple 23 can penetrate the front wall 521 and other tissues with a more precise axial movement, thereby reducing the probability of staple failure. In addition, the extension piece 232 can not only prevent the tail of the staple 23 from coming out after penetrating the front wall 521, but also slide in the wing cavity 2132 during staple ejection, which can further ensure that the staple 23 penetrates the front wall 521 and other tissues with a more precise axial movement.

[0069] In some preferred structures, such as Figure 7 As shown, each substrate unit 111 of the substrate component 11 has a countersunk groove 112 at its circumferential position corresponding to the staple 23. The countersunk groove 112 extends radially and penetrates to the outer edge of the substrate unit 111. During stapling, the head of the staple 23 passes through the rear wall 522 and is stopped by the bottom of the countersunk groove 112 of the substrate unit 111, causing the expandable portion 233 to expand. A reserved space is formed between the bottom of the countersunk groove 112 and the rear wall 522 to allow the expandable portion 233 to expand, thereby preventing stapling failure due to the expandable portion 233 expanding without passing through the rear wall 522. In addition, since the countersunk groove 112 extends radially to the outer edge of the substrate unit 111, interference between the staple head 234 and the substrate unit 111 can be avoided when the substrate unit 111 contracts radially.

[0070] In some preferred structures, such as Figure 5 and combined Figure 3As shown, shallow adhesive grooves 214 are machined circumferentially arranged on the end face 211 of the dummy sleeve 21. Multiple circular protrusions 524 are arranged circumferentially on the bottom of the outwardly turned edge of the patch sidewall 52 of the dural patch 50. Before attaching the dural patch 50, a bio-colloidal agent is coated in the adhesive grooves 214, allowing the circular protrusions 524 to embed into the adhesive grooves 214 for bonding. Thus, the dural patch 50 is attached to the end face 211 of the dummy. After the patch sidewall 52 of the dural patch 50 is fastened to the edge 202 of the opening 201 of the dural base 200, the bonding force between the dural patch 50 and the dural base 200 is greater than the adhesive force, allowing the end face 211 of the dummy to separate from the dural patch 50. The advantage of embedding the circular protrusion 524 into the adhesive groove 214 is that if the expansion action of the substrate unit 111 causes the hard film patch 50 to generate shear force relative to the stud end face 211, the circular protrusion 524 embedded in the adhesive groove 214 prevents the shear force from causing bonding failure, thereby avoiding the hard film patch 50 from separating from the stud end face 211 before studding.

[0071] like Figure 1 , Figure 2 , Figure 6 As shown, the handle operating component 30 includes a force-applying inner tube 31, a main tube, a first force-applying outer tube 33, a second force-applying outer tube 34, a first threaded sleeve 35 and a second threaded sleeve 36, a first force-applying holding component 371 and a second force-applying holding component 372, which are sequentially stacked. The tube assembly component 40 includes an intermediate inner tube 41, an intermediate main tube 42, a first intermediate outer tube 43, and a second intermediate outer tube 44, which are correspondingly connected to the surgical operating component and the anastomosis execution component 10.

[0072] The head of the main tube is connected to the guide sleeve 13 of the anastomosis execution component 10 via the intermediate main tube 42; the force-applying inner tube 31 is disposed in the main tube and can move axially relative to the main tube, the head of the force-applying inner tube 31 is connected to the driven inner tube 12 of the anastomosis execution component 10 via the intermediate inner tube 41, so that the driven inner tube 12 can be driven through the force-applying inner tube 31, and the tail of the force-applying inner tube 31 extends out of the tail of the main tube; the first force-applying outer tube 33 is sleeved on the main tube and can move axially relative to the main tube, the head of the first force-applying outer tube 33 is connected to the guide sleeve 13 of the anastomosis execution component 10 via the intermediate inner tube 42; the force-applying inner tube 33 is disposed in the main tube and can move axially relative to the main tube, the head of the first force-applying outer tube 33 is connected to the guide sleeve 13 of the anastomosis execution component 10 via the intermediate inner tube 42; the force-applying inner tube 31 is disposed in the main tube and can move axially relative to the main tube, the force-applying inner tube 33 is connected to the guide sleeve 13 of the anastomosis execution component 10 via the intermediate inner tube 42; the force-applying inner tube 31 is disposed in the main tube and can move axially relative to the main tube, the force-applying inner tube 31 ... The intermediate outer tube 43 is connected to the nail-dispensing sleeve 21 of the matching execution component 10, so that the nail-dispensing sleeve 21 can be driven by the first force-applying outer tube 33. The tail of the main body extends out of the tail of the first force-applying outer tube 33. The second force-applying outer tube 34 is sleeved outside the first force-applying outer tube 33 and can move axially relative to the first force-applying outer tube 33. The head of the second force-applying outer tube 34 is connected to the force-applying ring 221 of the nail-dispensing component of the matching execution component 10 through the second intermediate outer tube 44, so that the nail-pushing part 22 can be driven to move by the second force-applying outer tube 34 to perform the nail-dispensing action.

[0073] The first threaded sleeve 35 is screwed onto the tail of the main tube 32. The tail of the first threaded sleeve 35 is connected to the tail of the force-applying inner tube 31 via a first step and a first retaining ring 351 disposed on the force-applying inner tube 31, so that the force-applying inner tube 31 moves synchronously with the first threaded sleeve 35. By screwing the first threaded sleeve 35, the force-applying inner tube 31 is driven to move axially relative to the main tube 32, thereby driving the driven inner tube 12 to move axially relative to the guide sleeve 13. The second threaded sleeve 36 is screwed onto the tail of the first force-applying outer tube 33. The tail of the second threaded sleeve 36 is connected to the main tube 32 via a second step and a second retaining ring 361 disposed on the main tube 32, so that the force-applying inner tube 31 moves synchronously with the second threaded sleeve 36. By screwing the second threaded sleeve 36, the first force-applying outer tube 33 is driven to move axially relative to the main tube 32, thereby driving the nail-spitting sleeve 21 to move axially relative to the guide sleeve 13. Preferably, the main tube 32 between the first threaded sleeve 35 and the second threaded sleeve 36 has sufficient length to form a handle 321 that can be held by a doctor with one hand. To prevent the doctor from slipping when holding the handle 321, such as Figure 2 As shown, the outer peripheral surface of the handle 321 is machined into a rough surface.

[0074] The second force-applying outer tube 34 has a clearance window on its wall to expose the wall of the first force-applying outer tube 33. The first force-applying holding member 371 is attached to the wall of the first force-applying outer tube 33 through the clearance window, and the second force-applying holding member 372 is attached to the wall of the second force-applying outer tube 34. Furthermore, the second force-applying holding member 372 is closer to the tail of the first force-applying outer tube 33. Thus, pressure can be applied by two fingers of one hand to bring the two force-applying holding members closer together, driving the second force-applying outer tube 34 to move distally relative to the first force-applying outer tube 33, thereby driving the pusher part 22 to move distally relative to the rivet sleeve 21 to perform the rivet-pushing action. To prevent slippage between the fingers and the contact surfaces of the force-applying holding members when applying force, such as... Figure 2 As shown, the contact surface is machined to have a rough surface.

[0075] The following describes the procedure of anastomosing the dural patch 50 to the opening 201 of the dural 200 at the base of the skull in the sellar region using the aforementioned anastomosis device 100.

[0076] First, before performing the anastomosis, the edge 202 of the opening 201 of the dura mater 200 at the base of the skull is trimmed to obtain a circular opening 201.

[0077] Then, the dura mater patch 50 is detachably attached to the stapling end face 211 of the anastomosis execution member 10. Then, by turning the first threaded sleeve 35 of the handle operating member 30, the driven inner tube 12 of the anastomosis execution member 10 drives the substrate member 11 to switch to a contracted state consistent with the dura mater patch 50. Then, as... Figure 10As shown, by holding the handle 321 of the operating component 30, the anastomosis execution component 10 and the dural patch 50 thereon are delivered through the nasal cavity, the window of the anterior wall 400 of the sphenoid sinus, and the bone window 301 of the posterior wall 300 of the sphenoid sinus to the front of the opening 201 of the dura mater 200 at the base of the skull.

[0078] Then, as Figure 11 As shown, the posterior wall 52251 of the dural patch 50 in the contracted state reaches the posterior side of the skull base dural 200 through the opening 201, while the lateral wall 52 of the patch remains in the state of passing through the opening 201.

[0079] Then, as Figure 12 As shown, by rotating the first screw sleeve 35 of the operating component 30 in the opposite direction, the driven inner tube 12 is moved to the far end, thereby causing the circumferentially arranged substrate units 111 of the substrate component 11 to automatically reset to a state perpendicular to the axis of the driven inner tube 12. During the reset process, the patch sidewall 52 is forced to bend to form a shape with a front wall 521, a rear wall 522 and an annular gap 523, so that the edge 202 of the opening 201 is embedded in the annular gap 523 between the front wall 521 and the rear wall 522, and the substrate component 11 is located on the rear side of the rear wall 522.

[0080] Then, by turning the second screw sleeve 36 of the handle operating component 30, the nail ejector sleeve 21 is driven to move toward the distal end so that the substrate component 11 and the nail ejector end face 211 together clamp the front wall 521, the edge 202 of the opening 201 and the rear wall 522.

[0081] Then, as Figure 13 As shown, by simultaneously applying pressure to the first force-applying gripping member 371 and the second force-applying gripping member 372 on the handle operating member 30, the pusher member 22 is driven to perform a pusher action, thereby causing the staples 23 arranged circumferentially in the staple ejection cavity 213 of the staple ejection sleeve 21 to be ejected synchronously from the staple ejection end face 211 and sequentially pass through the front wall 521 of the patch sidewall 52, the edge 202 of the opening 201, and the rear wall 522 of the patch sidewall 52, and are stopped by the substrate unit 111 to achieve the staple engagement of the front wall 521, the edge 202 of the opening 201, and the rear wall 522.

[0082] Then, as Figure 14 As shown, by twisting the first screw sleeve 35 in the reverse direction again, the driven inner tube 12 is driven to move towards the proximal end, which causes each substrate unit 111 of the substrate component 11 to contract. Then, the anastomosis execution component 10 is pulled backward. Because the bonding force between the front wall 521 of the patch sidewall 52 and the staple 23 is greater than the bonding force between the front wall 521 of the patch and the end face 211 of the staple, the anastomosis execution component 10 is separated from the dura mater patch 50, thus completing the anastomosis of the dura mater patch 50 and the dura mater 200 at the base of the skull.

[0083] Furthermore, although exemplary embodiments have been described in this invention, their scope includes any and all embodiments based on the invention that have equivalent elements, modifications, omissions, combinations (e.g., schemes involving intersections of various embodiments), adaptations, or alterations. Elements in the claims will be interpreted broadly based on the language used in the claims and are not limited to the examples described in this specification or during the implementation of this application, and such examples will be interpreted as non-exclusive. Therefore, this specification and examples are intended to be considered illustrative only, and the true scope and spirit are indicated by the full scope of the following claims and their equivalents.

[0084] The above description is intended to be illustrative and not restrictive. For example, the above examples (or one or more of them) can be used in combination with each other. Other embodiments may be used by those skilled in the art upon reading the above description. Furthermore, in the above detailed description, various features may be grouped together to simplify the invention. This should not be construed as an intention that a disclosed feature, which is not claimed, is necessary for any claim. Rather, the subject matter of the invention may be less than all the features of the particular disclosed embodiment. Thus, the following claims are incorporated herein by reference as examples or embodiments, wherein each claim is independently considered as a separate embodiment, and these embodiments are contemplated as being possible in various combinations or arrangements. The scope of the invention should be determined by reference to the appended claims and the full scope of their equivalents.

[0085] The above embodiments are merely exemplary embodiments of the present invention and are not intended to limit the present invention. The scope of protection of the present invention is defined by the claims. Those skilled in the art can make various modifications or equivalent substitutions to the present invention within its spirit and scope of protection, and such modifications or equivalent substitutions should also be considered to fall within the scope of protection of the present invention.

Claims

1. A skull base dural anastomosis device, characterized in that, include: The device comprises a tubular assembly having distal and proximal ends, an anastomosis execution component attached to the distal end of the tubular assembly, a handle operating component attached to the proximal end of the tubular assembly for performing anastomosis actions by driving the anastomosis execution component through the tubular assembly, and a dural patch detachably attached to the anastomosis execution component for anastomosing to an opening in the dura mater at the base of the skull; wherein: The dural patch includes a patch base wall and patch sidewalls surrounding the patch base wall. By bending the patch sidewalls, an anterior wall and a posterior wall opposite to each other and an annular gap between them are formed on them. By making the patch sidewalls pass through the opening of the dura mater at the base of the skull, the edge of the opening is radially embedded into the annular gap and between the anterior wall and the posterior wall. The anastomosis execution component includes at least a substrate component and a staple ejection mechanism, such that the substrate component is located on the rear side of the rear wall, and the staple ejection mechanism is located on the front side of the front wall and is driven by the handle operation component to eject staples from the front wall and cause the staples to pass through the front wall, the dura mater at the opening edge of the skull base, and the rear wall in sequence, and be stapled together by the stop of the substrate component. The matching execution component further includes a guide sleeve and a driven inner tube. The staple ejection mechanism is located radially outside the guide sleeve and can simultaneously eject multiple circumferentially arranged staples. The driven inner tube is located radially inside the guide sleeve and can move axially relative to the guide sleeve. Wherein: The substrate component includes a plurality of circumferentially arranged plate-shaped substrate units integrally formed on the tube wall of the port of the driven inner tube. The plurality of substrate units correspond to the circumferential positions of the staples being ejected. The substrate units are radially contracted by elastic deformation and are elastically restored to a state perpendicular to the axis of the driven inner tube. Thus, when the driven inner tube is driven by the handle operating component to move towards the proximal end and apply a pulling force to the radially inward side of the substrate unit, the port of the guide sleeve forces the substrate unit to contract radially. When the driven inner tube is released, the substrate unit automatically elastically restores to the unfolded state to stop the staples.

2. The skull base dura mater anastomosis device according to claim 1, characterized in that, The nail-dispensing mechanism includes: The staple ejector sleeve is fitted outside the guide sleeve. The staple ejector sleeve has a staple ejector end face facing the front wall of the dura mater and a stepped surface facing the opposite direction to the staple ejector end face. Multiple staple ejector cavities are provided on the sleeve wall between the staple ejector end face and the stepped surface, and the staples are placed in the staple ejector cavities. The nail-pushing component includes a force-applying ring axially opposite to the stepped surface of the nail-dispensing sleeve and movable relative to the nail-dispensing sleeve, and push rods circumferentially arranged on the force-applying ring and extending from one side of the stepped surface into the bottom of the nail-dispensing cavity; wherein: The force ring is driven by the handle operating component, causing multiple push rods to push the staples in the staple cavity synchronously out of the staple ejection end face and through the anterior wall, the dura mater of the skull base at the opening edge, and the posterior wall.

3. The skull base dura mater anastomosis device according to claim 2, characterized in that, The ejector sleeve is configured to be axially movable relative to the guide sleeve such that, before ejecting the nail, the ejector sleeve is driven by the handle operating component to move axially relative to the guide sleeve to apply pressure to the front wall of the dura mater patch.

4. The skull base dura mater anastomosis device according to claim 2, characterized in that, The front wall of the hard film patch can be separably attached to the nail-spitting end face of the nail-spitting sleeve through multiple circumferentially arranged adhesive areas.

5. The skull base dura mater anastomosis device according to claim 2, characterized in that, The staple includes a columnar segment with a radially protruding extension at the tail end, and the staple cavity includes a main cavity for accommodating the columnar segment and a wing cavity surrounding the main cavity for accommodating the extension. The head of the columnar segment is provided with an expandable portion, which includes a staple head, a plurality of elastic lines arranged circumferentially between the staple head and the columnar segment, a backstop hole opened in the columnar segment, and a backstop extending from the staple head toward the backstop hole and having barbs on its outer peripheral surface. After the staple head passes through the rear wall of the hard film patch and contacts the substrate unit, the substrate unit pushes the staple head in the opposite direction to cause the expandable portion to expand radially and insert the backstop into the backstop hole so that the expandable portion remains in an expanded state.

6. The skull base dura mater anastomosis device according to claim 5, characterized in that, Each substrate unit of the substrate component has a recessed groove at the circumferential position corresponding to the staple, and the recessed groove extends radially and penetrates to the outer edge of the substrate unit.

7. The skull base dura mater anastomosis device according to claim 2, characterized in that, The driven inner tube is restricted from rotating relative to the guide sleeve, and the nail-spitting sleeve is restricted from rotating relative to the guide sleeve.

8. The skull base dura mater anastomosis device according to claim 2, characterized in that, The handle operating component includes: The main tube is connected to the guide sleeve via tube assembly components; The force-applying inner tube is disposed in the main tube and connected to the driven inner tube through the tube assembly to drive the driven inner tube, and the tail of the force-applying inner tube extends out of the tail of the main tube. The first threaded sleeve is screwed onto the tail of the main tube. The tail of the first threaded sleeve is connected to the tail of the force-applying inner tube. By screwing the first threaded sleeve, the force-applying inner tube is driven to move axially relative to the main tube. The first force-applying outer tube is sleeved outside the main tube and connected to the nail-spitting sleeve through the tube assembly to drive the nail-spitting sleeve. The main tube extends out of the tail of the first force-applying outer tube. The second threaded sleeve is screwed onto the tail of the first force-applying outer tube. The tail of the second threaded sleeve is connected to the main tube. By screwing the second threaded sleeve, the first force-applying outer tube is driven to move axially relative to the main tube. The second force-applying outer tube is sleeved outside the first force-applying outer tube and connected to the force-applying ring through the tube assembly to drive the force-applying ring. The force-applying holding component includes two components, which are respectively mounted on the first force-applying outer tube and the second force-applying outer tube. By simultaneously applying an axial force to the two force-applying holding components, the second force-applying outer tube moves axially toward the distal end relative to the first force-applying outer tube to drive the pusher component to perform a pusher action.

9. The skull base dura mater anastomosis device according to claim 8, characterized in that, The second force-applying outer tube has a clearance window on its tube wall. One force-applying holding component is attached to the tube wall of the second force-applying outer tube, and the other force-applying holding component is attached to the first force-applying outer tube through the clearance window. The force-applying holding component attached to the second force-applying outer tube is closer to the tail of the first force-applying outer tube than the force-applying holding component attached to the first force-applying outer tube.

10. The skull base dura mater anastomosis device according to claim 8, characterized in that, A handle for human hand gripping is provided on the main tube between the first threaded sleeve and the second threaded sleeve.

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