Suturing nail assembly, suturing nail device for endoscope and nail replacing method of suturing nail device

Abstract

The invention discloses a suturing nail assembly, a suturing nail device for an endoscope and a nail replacing method of the suturing nail assembly. The suturing nail assembly comprises a suturing nail and an elastic piece, the suturing nail is of a tubular structure and is hollow, and the front end of the suturing nail is provided with a nail-shaped structure suitable for being implanted into target tissue; the front end of the elastic piece is provided with a stop part, and the rear end of the elastic piece is provided with an elastic hook. Wherein at least part of the front side of the elastic piece is located in the suturing nail with the hollow interior, and the elastic piece is relatively and fixedly connected with the suturing nail; and the backstop part and the elastic hook are configured to be penetrated by the handle assembly and open the elastic hook, so that the suturing nail assembly is hung on the handle assembly. Through the design of the elastic piece, assembling and releasing between the suturing nail and the handle assembly can be achieved, the stability of assembling and releasing force values is guaranteed, the surgical risk is reduced, the surgical time is shortened, and medical staff can operate more easily.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a suture staple assembly, an endoscope suture staple device and a staple replacement method thereof. Background Art

[0002] A stapler device generally includes a detachably connected staple assembly and a handle assembly. The stapler device uses the handle assembly to implant the staple assembly into human tissue. During surgery, to close a large wound, multiple staple assemblies are typically implanted into the tissue and then pulled together to close the wound and stop bleeding. During operation, the staple assemblies are implanted one by one, screwed into the tissue, and then the handle assembly is withdrawn to install another set of staple assemblies. When replacing a staple assembly, current structural designs often include a locating member on the release head and a locating member on the inner wall of the staple assembly. Forced assembly and release are achieved through an interference gap between the two locating members. During forced assembly, the assembly force is controlled solely by controlling the size of the locating members. This method results in poor assembly force stability, which can make assembly difficult or even impossible during surgery. This can cause the surgery to stall, prolong the operation, and significantly increase the difficulty of the surgery. Summary of the Invention

[0003] In order to solve the technical problems in the prior art of poor assembly force stability when assembling a suture staple device and a release head, which makes assembly difficult or even impossible, the present invention provides a suture staple assembly, an endoscopic suture staple device and a staple replacement method thereof to solve the above problems.

[0004] The present invention provides a suture staple assembly comprising a suture staple and an elastic member. The suture staple is tubular, hollow, and has a front end provided with a nail-like structure suitable for implantation into target tissue. The front end of the elastic member has a stopper, and the rear end of the elastic member has an elastic hook. The front side of the elastic member is at least partially located within the hollow interior of the suture staple and is relatively fixedly connected to the suture staple. The stopper and elastic hook are configured to pass through a handle assembly, which then extends the elastic hook to mount the suture staple assembly on the handle assembly.

[0005] In an optional embodiment of the present invention, the elastic member includes a tubular body, and the stopper portion includes a plurality of claws formed by slotting one end of the tubular body along the axial direction.

[0006] In an optional embodiment of the present invention, a positioning piece is provided on the outer peripheral surface of the elastic piece, and the suture nail is provided with a fixing hole for the positioning piece to pass through.

[0007] In an optional embodiment of the present invention, the end of the tubular body away from the stop portion has a first long slot extending axially, the elastic hook is arranged at the first long slot, and the elastic hook protrudes axially from the end of the tubular body.

[0008] In an optional embodiment of the present invention, the suture nail further includes a winding groove connected to the nail-like structure and a connecting tube connected to the winding groove, the fixing hole is located on the connecting tube, and the connecting tube has a second long groove extending in the axial direction.

[0009] In an optional embodiment of the present invention, when the handle assembly passes through the elastic member, the elastic hook can be stretched outward along the second long slot.

[0010] The present invention also provides an endoscopic suture staple device, comprising a suture staple assembly and a handle assembly, wherein the handle assembly is detachably connected to the suture staple assembly, and the suture staple assembly is the suture staple assembly described above.

[0011] In an optional embodiment of the present invention, the handle assembly includes a release head, which is driven by a pulling device. The release head includes a circumferential limiting section, a connecting section and an axial limiting section connected axially, and the axial limiting section has a step surface at one end facing the connecting section.

[0012] The release head passes through the center of the elastic member at the end where the elastic hook is located, and the release head can make the elastic hook expand and hook the round table surface of the end cap in the pulling instrument; when the suture nail device is assembled, the circumferential limit section is fixed to the elastic member circumferentially, and the step surface abuts against the outer end surface of the stop portion.

[0013] In an optional embodiment of the present invention, the circumferential limiting section is provided with a plurality of rotating blocks arranged at intervals along the circumferential direction, and the end of the elastic member away from the stop portion has a rotating groove that cooperates with the rotating block.

[0014] In an optional embodiment of the present invention, one end of the release head connected to the pulling device has a limiting ring. When the suturing nail device is assembled, the front end surface of the limiting ring abuts against the inner end surface of the pulling device for limiting position.

[0015] The present invention further provides a staple replacement method, which uses the above-mentioned endoscopic staple device and includes the following steps: S1: Assembling the suture staple assembly: insert the elastic member into the suture staple and fix them to each other, with the rear end of the elastic member extending out of the suture staple.

[0016] S2: Install the extended end of the elastic member in step S1 into the end cap of the pulling device.

[0017] S3: Assembly of the release head and the stapling nail assembly: first, the release head is inserted into the stapling nail assembly by the pulling instrument, so that the elastic hook is expanded and abuts against the end of the end cap, the release head is continuously pushed forward, the circumferential limiting segment is exposed from the end cap, then the stapling nail assembly is rotated, the circumferential limiting segment of the release head is limited by the elastic piece, finally the stapling nail assembly is pressed down, the axial limiting segment passes through the stopper to complete the assembly.

[0018] S4: Release of the stapling nail assembly: the pulling instrument is pulled back, the release head is moved backward, and the release head is separated from the stapling nail assembly by passing through the stopper.

[0019] The beneficial effects of the present application are: (1) The present application can solve the assembly and release between the stapling nail and the handle assembly through the design of the elastic piece, ensure the stability of the assembly and release force value, reduce the operation risk, shorten the operation time, and make the operation of the medical staff simpler.

[0020] (2) The present application has simple structure, convenient assembly and small occupied area.

[0021] (3) The present application separates the stapling nail which plays a role in suturing and the part (i.e. the elastic piece) of the connecting handle assembly from each other through the split structure design, so that the processing and replacement cost of the parts can be reduced. BRIEF DESCRIPTION OF DRAWINGS

[0022] The present application will be further described below in combination with the drawings and examples.

[0023] Figure 1 is a perspective view of the elastic piece in the present application; Figure 2 is a perspective view of the stapling nail in the present application; Figure 3 is a perspective view of the release head in the present application; Figure 4 is a perspective view of the stapling nail assembly in the present application; Figure 5 is a state diagram when the rear end of the stapling nail assembly is placed into the end cap; Figure 6 is a state diagram when the release head props open the elastic hook; Figure 7 is a state diagram when the release head pushes out the lock and adjusts the position of the stapling nail assembly; Figure 8 is a state diagram when the stapling nail assembly and the release head are completely assembled.

[0024] In the figure, 1. suture staple, 101. staple-shaped structure, 102. winding groove, 103. connecting tube, 2. release head, 201. circumferential limiting section, 202. connecting section, 203. axial limiting section, 204. limiting ring, 3. elastic member, 301. stopper, 302. elastic hook, 303. tubular body, 4. step surface, 5. pulling instrument, 6. end cap, 601. frustum surface, 7. suture staple assembly, 8. pull rope, 9. claw, 901. outer end surface, 10. first long groove, 11. positioning member, 12. fixing hole, 13. rotary block, 14. rotating groove, 15. second long groove. DETAILED DESCRIPTION

[0025] The following describes embodiments of the present invention in detail. Examples of the embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals throughout represent the same or similar elements or elements having the same or similar functions. The embodiments described below with reference to the accompanying drawings are exemplary and are intended only to explain the present invention and are not to be construed as limiting the present invention.

[0026] In the present invention, the term "front" indicating the direction refers to the end close to the soft tissue in the use state, and "back" refers to the end close to the pulling instrument 5 in the use state.

[0027] Example 1 like Figures 1-4 As shown, a suture nail assembly includes a suture nail 1 and an elastic member 3. The suture nail 1 is a tubular structure with a hollow interior, and a front end is provided with a nail-like structure 101 suitable for implantation into the target tissue, which is used to anchor the wound of the soft tissue for suturing; the front end of the elastic member 3 has a stopper 301, and the rear end of the elastic member 3 has an elastic hook 302, wherein the front side of the elastic member 3 is at least partially located in the hollow interior of the suture nail 1 and is relatively fixedly connected to the suture nail 1; the stopper 301 and the elastic hook 302 are configured to be passed through by the handle assembly, and the elastic hook 302 is stretched open, so that the suture nail assembly is mounted on the handle assembly, thereby realizing the assembly connection between the handle assembly and the suture nail assembly.

[0028] The stopper 301 is at the front end of the elastic member 3, and can prevent the handle assembly from moving toward the rear end of the elastic member 3 and detaching after the handle assembly and the elastic member 3 are assembled. The elastic hook 302 can be mounted on the handle assembly (specifically, on the end cap 6 of the handle assembly) after being expanded, and can be detached from the end cap 6 after being contracted. The expandable and contractible properties of the elastic member 3 enable it to clamp the handle assembly, thereby connecting the suture staple 1 and the handle assembly, and can also release the handle assembly under the action of an external force.

[0029] The main body of the elastic member 3 is a tubular structure, namely the tubular body 303 . The tubular body 303 refers to a columnar structure with a hollow interior. The stopper 301 and the elastic hook 302 are formed on the basis of the tubular body 303 or are directly installed on the tubular body 303 .

[0030] In this embodiment, the stopper 301 is formed on the basis of the tubular body 303. Specifically, the stopper 301 includes a plurality of claws 9 formed by slotting one end of the tubular body 303 along the axial direction. Figure 1 As shown, the stopper 301 is composed of four claws 9, each claw 9 having a fixed rear end and a free front end, thereby forming a stopper 301 with elastic expansion capability. The stopper 301 can clamp the end of the handle assembly to prevent the handle assembly from shaking and prevent the handle assembly from separating from the elastic member 3.

[0031] In this embodiment, the elastic hook 302 is directly mounted on the tubular body 303. The elastic hook 302 is the same as the claw 9, with one end fixed and the other end free to move, thereby achieving elastic performance. The elastic hook 302 extends backward, in the opposite direction of the extension of the claw 9. Figure 1 As shown, two elastic hooks 302 are symmetrically provided on the tubular body 303. To provide elastic deformation space for the elastic hooks 302, preferably, the end of the tubular body 303 away from the stop portion 301 has a first axially extending long slot 10. The elastic hooks 302 are disposed in the first long slot 10 and protrude axially from the end of the tubular body 303. The axial protrusion of the elastic hooks 302 ensures that the engagement of the elastic hooks 302 with the end cap 6 and the position limiting of the handle assembly and the elastic member 3 are at different cross-sections to avoid structural interference.

[0032] The suture staple 1 generally includes a winding groove 102 connected to the nail-like structure 101 and a connecting tube 103 connected to the winding groove 102. The outer diameter of the winding groove 102 is smaller than the outer diameters of the nail-like structure 101 and the connecting tube 103. A threading component is mounted on the winding groove 102. The fixing hole 12 is located on the connecting tube 103. The connecting tube 103 has a second long groove 15 extending axially. The elastic hook 302 corresponds to the second long groove 15 and is used to make way for the elastic hook 302. When the handle assembly passes through the elastic member 3, the elastic hook 302 can be stretched outward along the second long groove 15.

[0033] The elastic member 3 and the suture staple 1 can be fixed by snap fastening, screw fastening, welding, etc.

[0034] Example 2 A suture staple device for endoscope, a suture staple assembly and a handle assembly, wherein the handle assembly is detachably connected to the suture staple assembly, and the suture staple assembly is the suture staple assembly described above.

[0035] The handle assembly may, but is not limited to, adopt the following structure: The handle assembly includes a pulling device 5 and a release head 2. In this embodiment, the release head 2 is improved. The release head 2 is driven by the pulling device 5. The release head 2 includes a circumferential limiting section 201, a connecting section 202 and an axial limiting section 203 connected axially. The axial limiting section 203 has a step surface 4 at one end facing the connecting section 202.

[0036] The release head 2 passes through the center of the elastic member 3 along the end where the elastic hook 302 is located. The release head 2 can make the elastic hook 302 expand and then hook the conical surface 601 of the end cap 6 of the pulling instrument 5; when the suture nail device is assembled, the circumferential limit section 201 is circumferentially fixed to the elastic member 3, so that the release head 2 can drive the elastic member 3 and the suture nail 1 to rotate synchronously, and the step surface 4 abuts against the outer end surface 901 of the stop portion 301 to prevent the release head 2 from moving axially along the stop portion 301 and separating from the stop portion 301 during the suturing process.

[0037] The pulling device 5 is connected to the release head 2 by a cable 8 by pushing and pulling the handle, thereby controlling the release head 2 to be pushed forward or retracted backward. When the release head 2 is pushed forward, the axial limiting section 203 of the release head 2 passes through the stop portion 301 of the elastic member 3 to complete the assembly, which can drive the suture staple assembly 7 composed of the elastic member 3 and the suture staple 1 to rotate. When the release head 2 is retracted backward, since the stop portion 301 has the elasticity of telescoping or expanding, the axial limiting section 203 of the release head 2 can open the stop portion 301 and disengage from the elastic member 3, thereby realizing the release of the suture staple assembly 7.

[0038] like Figure 3 As shown, the outer diameter of the axial limiting section 203 of the release head 2 is larger than that of the connecting section 202, thereby forming a stepped surface 4 on the end surface of the axial limiting section 203. In a further design, the front end of the stopper 301 is folded inward, and the end of each claw 9 is bent inward to form an outer end surface 901 that abuts against the stepped surface 4. After assembly, the inner circumference of the front end of the claw 9 is clamped on the connecting section 202. The front end of the stopper 301 is folded inward, on the one hand, to better clamp the end of the release head 2 to prevent the release head 2 from shaking, and on the other hand, to form the outer end surface 901 axially limited to the stepped surface 4 to prevent the release head 2 from separating from the elastic member 3.

[0039] To ensure a tight engagement, the inner circumference of the distal end of each claw portion 9 preferably forms a circular surface that mates with the connecting section 202. When the release head 2 is pushed forward, the axial limiting section 203 pushes against the stopper 301, causing its front end to open. After the axial limiting section 203 passes over the inwardly turned portion of the front end of the stopper 301, the front end of the stopper 301 returns to its original position and contracts, enclosing the connecting section 202.

[0040] In a preferred embodiment, the end of the axial limiting section 203 away from the connecting section 202 is a tapered surface, which makes it easier to push the stopper 301 forward.

[0041] A staple replacement method, using the endoscopic staple device described in this embodiment, comprises the following steps: S1: Assembling the suture nail assembly 7: Insert the elastic member 3 into the suture nail 1 and fix them together, and the rear end of the elastic member 3 extends out of the suture nail 1, as shown in FIG. Figure 4 shown.

[0042] S2: Install the extended end of the elastic member 3 in step S1 into the end cap 6 of the pulling device 5 (as shown in FIG. Figure 5 As shown), the elastic hook 302 can be manually squeezed to shrink it into the end cap 6. Since the elastic hook 302 is tough, when the suture nail assembly 7 is released, the elastic hook 302 can be deformed and separated from the end cap 6 by a slight pull.

[0043] S3: Assembly of the release head 2 and the staple assembly 7: First, the release head 2 is pushed by the pulling device 5 and inserted into the staple assembly 7, so that the elastic hook 302 expands and abuts against the end of the end cap 6 (as shown in FIG. Figure 6 As shown in FIG5 ), the release head 2 is pushed forward to expose the circumferential limit section 201 to the end cap 6, and then the staple assembly 7 is rotated to limit the circumferential limit section of the release head 2 and the elastic member 3 circumferentially. At this time, the axial limit section 203 does not penetrate the stopper 301 (as shown in FIG5 ). Figure 7 As shown), finally, press down the staple assembly 7 so that the axial limiting section 203 passes through the stopper 301 to complete the assembly (as shown Figure 8 shown).

[0044] S4: Release the suture staple assembly 7: The pulling device 5 is pulled back, driving the release head 2 to move backward, and the release head 2 passes over the stopper 301 and disengages from the suture staple assembly 7.

[0045] Example 3 Based on the second embodiment, Figure 1 and Figure 2As shown, the outer surface of the elastic member 3 is provided with a positioning member 11, and the suture staple 1 is provided with a fixing hole 12 for the positioning member 11 to pass through. When assembling the suture staple assembly 7, the elastic member 3 is first inserted into the suture staple 1, so that the positioning member 11 enters the fixing hole 12, thereby achieving relative fixation between the two. Then, welding is performed to strengthen the fixation. This speeds up installation and improves installation accuracy.

[0046] The circumferential fixation of the release head 2 and the elastic member 3 can be achieved by contacting and fitting non-circular surfaces. This embodiment adopts the following structure: like Figure 1 and Figure 3 As shown, the circumferential limit segment 201 is provided with a plurality of spaced-apart rotating blocks 13 along the circumference. The end of the elastic member 3, away from the stop portion 301, has a rotating groove 14 that mates with the rotating blocks 13. Specifically, the rotating groove 14 is located at the rear end of the elastic member 3. During installation, the rotating blocks 13 are inserted through the rear end opening of the rotating groove 14.

[0047] In order to limit the push-out limit of the release head 2 and prevent the release head 2 from being pushed out excessively, in this embodiment, the release head 2 has a limiting ring 204 at one end connected to the pulling device 5. When the suture nail device is assembled, the front end face of the limiting ring 204 abuts against the inner end face of the pulling device 5 for limiting position.

[0048] A staple replacement method, using the endoscopic staple device described in this embodiment, comprises the following steps: S1: Assembling the suture staple assembly 7: Insert the elastic member 3 from one end of the connecting tube 103 into the suture staple 1, so that the positioning member 11 and the fixing hole 12 are fixed in position corresponding to each other to form the suture staple assembly 7. The fixing method can be welding. After fixing, the rear end of the elastic member 3 (including the end of the elastic hook 302 and the rotating groove 14) extends out of the suture staple 1.

[0049] S2: The extended end of the elastic member 3 in step S1 is installed into the end cap 6 of the pulling device 5. In the free state, the elastic hook 302 can directly pass through the outlet of the end cap 6 to facilitate the release of the suture staple assembly 7.

[0050] S3: Assembly of the release head 2 and the suture staple assembly 7: First, the release head 2 is pushed forward by the pulling device 5 and inserted into the suture staple assembly 7. When the conical surface of the release head 2 touches the elastic hook 302, the elastic hook 302 is stretched and hooks the step surface 4 of the end cap 6 to fix the suture staple assembly 7 and the end cap 6. Figure 6 As shown, then, push the release head 2 forward until it can no longer be pushed. At this time, the circular table at the rear end of the release head 2 touches the end surface of the end cap 6, and the rotary block 13 on the release head 2 can extend out of the end cap 6 and is visible to the naked eye. Figure 7As shown, the suture staple assembly 7 is manually rotated so that the rotation groove 14 on the elastic member 3 is aligned with the rotation block 13, and then the front end of the suture staple assembly 7 is pressed with force. Since the release head 2 is stationary, the axial limit section 203 of the release head 2 can pass through the end of the stop portion 301 of the suture staple assembly 7, thereby successfully assembling the suture staple assembly 7 and the release head 2 (as shown in FIG. Figure 8 As shown), at this time, the rotation and fixation of the nail-like structure 101 component can be achieved.

[0051] S4: Release the suture staple assembly 7: The pulling device 5 is pulled back, driving the release head 2 to move backward, and the release head 2 passes over the stopper 301 and disengages from the suture staple assembly 7.

[0052] In this specification, the schematic representations of the terms do not necessarily refer to the same embodiment. Moreover, the specific features, structures, materials or characteristics described can be combined in any suitable manner in any one or more embodiments.

[0053] With the above-described preferred embodiments of the present invention as a guide, and with reference to the above description, relevant personnel are fully capable of making various changes and modifications without departing from the technical scope of this invention. The technical scope of this invention is not limited to the contents of the specification and must be determined according to the scope of the claims.

Claims

1. A suture staple assembly, characterized in that: include: The suture staple (1) is a tubular structure, hollow inside, and has a staple-shaped structure (101) at the front end suitable for implantation into the target tissue; An elastic member (3), wherein the front end of the elastic member (3) has a stopper (301), and the rear end of the elastic member (3) has an elastic hook (302); Wherein, the front side of the elastic member (3) is at least partially located inside the hollow interior of the suture nail (1) and is relatively fixedly connected to the suture nail (1); The stopper (301) and the elastic hook (302) are configured to be passed through by the handle assembly, and to open the elastic hook (302) so as to mount the suture nail assembly on the handle assembly.

2. The staple assembly according to claim 1, wherein: The elastic member (3) comprises a tubular body (303), and the stopper (301) comprises a plurality of claws (9) formed by slotting one end of the tubular body (303) along the axial direction.

3. The staple assembly according to claim 2, wherein: An end of the tubular body (303) away from the stopper (301) has a first long slot (10) extending axially, and the elastic hook (302) is arranged at the first long slot (10), and the elastic hook (302) protrudes axially from the end of the tubular body (303).

4. The staple assembly according to claim 1, wherein: A positioning piece (11) is provided on the outer peripheral surface of the elastic piece (3), and the suture nail (1) is provided with a fixing hole (12) for the positioning piece (11) to pass through.

5. The staple assembly according to claim 4, wherein: The suture nail (1) further comprises a winding groove (102) connected to the nail-shaped structure (101) and a connecting tube (103) connected to the winding groove (102); the fixing hole (12) is located on the connecting tube (103); and the connecting tube (103) has a second long groove (15) extending in the axial direction.

6. The staple assembly according to claim 5, wherein: During the process of the handle assembly passing through the elastic member (3), the elastic hook (302) can be stretched outward along the second long slot (15).

7. An endoscopic staple device, comprising a staple assembly and a handle assembly, characterized in that: The handle assembly is detachably connected to the suture staple assembly, and the suture staple assembly is the suture staple assembly according to any one of claims 1 to 6.

8. The endoscopic staple device according to claim 7, wherein: The handle assembly comprises a release head (2), the release head (2) being driven by a pulling device (5), the release head (2) comprising a circumferential limiting section (201), a connecting section (202) and an axial limiting section (203) connected in an axial direction, and the axial limiting section (203) has a step surface (4) at one end facing the connecting section (202); The release head (2) passes through the center of the elastic member (3) at the end where the elastic hook (302) is located, and the release head (2) can make the elastic hook (302) expand and hang on the round table surface (601) of the end cap (6) of the pulling device (5); when the suturing nail device is assembled, the circumferential limit section (201) is circumferentially fixed to the elastic member (3), and the step surface (4) abuts against the outer end surface (901) of the stop portion (301).

9. The endoscopic staple device according to claim 8, wherein: The circumferential limiting section (201) is provided with a plurality of rotating blocks (13) arranged at intervals along the circumferential direction, and one end of the elastic member (3) away from the stop portion (301) is provided with a rotating groove (14) that cooperates with the rotating block (13).

10. The endoscopic staple device according to claim 8, wherein: One end of the release head (2) connected to the pulling device (5) is provided with a limiting ring (204). When the suture nail assembly is assembled, the front end surface of the limiting ring (204) abuts against the inner end surface of the pulling device (5) to limit the position.

11. A nail replacement method, characterized in that: The method is applied to the endoscopic staple device according to any one of claims 8 to 10, comprising the following steps: S1: Assembling the suture staple assembly (7): inserting the elastic member (3) into the suture staple (1) and fixing them to each other, with the rear end of the elastic member (3) extending out of the suture staple (1); S2: inserting the extended end of the elastic member (3) in step S1 into the end cap (6) of the pulling device (5); S3: Assembly of the release head (2) and the suture nail assembly (7): First, the release head (2) is pushed by the pulling device (5) to be inserted into the suture nail assembly (7), so that the elastic hook (302) expands and abuts against the end of the end cap (6), and the release head (2) is pushed forward to make the circumferential limit section (201) exposed forward from the end cap (6), and then the suture nail assembly (7) is rotated to make the circumferential limit section (201) of the release head (2) and the elastic member (3) circumferentially limit each other, and finally the suture nail assembly (7) is pressed downward to make the axial limit section (203) pass through the stopper (301) to complete the assembly; S4: Release the suture staple assembly (7): The pulling device (5) is pulled back, driving the release head (2) to move backward, and the release head (2) passes over the stopper (301) and disengages from the suture staple assembly (7).

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