CN212996584U

CN212996584U - Guide piece and circular tube type anastomat

Info

Publication number: CN212996584U
Application number: CN202020796203.7U
Authority: CN
Inventors: 叶艳平; 王文建; 张素梅; 付丞磊; 黄斌
Original assignee: Suzhou Tianchen International Medical Technology Co Ltd
Current assignee: Touchstone International Medical Science Co Ltd; Suzhou Tianchen International Medical Technology Co Ltd
Priority date: 2020-05-14
Filing date: 2020-05-14
Publication date: 2021-04-20
Anticipated expiration: 2030-05-14

Abstract

The utility model provides a guide piece and circular tube type anastomat, the guide piece is used for guiding the nail storehouse subassembly of circular tube type anastomat to get into the operation position, include: a guide body located on the distal side of the cartridge, the guide being helically wound from a flexible band and having an outer diameter less than the outer diameter of the distal side of the cartridge; at least one connecting part, the distal end side of the connecting part is connected with the guide body, and the proximal end side of the connecting part is connected with the inner side of the nail barrel; when the guide is subjected to a pulling force toward the proximal side, the guide body may be spirally disassembled into a band-like structure. Through this guide, on the basis that does not basically increase nail storehouse subassembly external diameter, can guide nail storehouse subassembly to get into inside the tissue well to after nail storehouse subassembly reaches the operation position, the guide can easily break away from cartridge distal end side.

Description

Guide piece and circular tube type anastomat

Technical Field

The utility model relates to the technical field of medical equipment, concretely relates to guide piece and circular tube type anastomat.

Background

In the prior art, a circular tube-type anastomat comprises an anastomat body, an operating handle movably connected with the anastomat body and a nail anvil assembly matched with the anastomat body. The anastomat body comprises a firing assembly and a nail bin assembly arranged on the far end side. In the operation process, two sections of tissues to be anastomosed are placed between the nail anvil of the nail anvil assembly and the nail bin of the nail bin assembly, the distance between the nail anvil and the nail bin is adjusted to gradually clamp the tissues, and then the trigger assembly is driven by the operation handle to enable the anastomotic nails to be formed on the nail anvil, so that anastomotic connection of the two sections of tissues is completed.

During the actual operation, the body portion of the circular tube-type stapler, i.e., the cartridge portion, needs to enter the tissue tract from one end of the tissue. For example, in low rectal surgery, access is required through the anus, which is a muscular opening and is in a contracted state, making it difficult to insert instruments having a large outer diameter into the anus. As another example, in a gastric bypass or gastric cufflated procedure, the body of the stapler is required to enter the small intestine through a tissue stump and traverse a distance in the small intestine. The small intestine is in a separation state after the pathological tissue is cut off in the operation, and the intestinal walls are in a state of being attached together, so that the nail barrel part of the circular tube type anastomat is not easy to enter the tubular tissue, meanwhile, the inner wall of the digestive tract is a tissue mucosa, and the circular tube type anastomat is easy to damage the mucosa when passing in the small intestine.

Although some guide devices have appeared in the prior art, the existing guide devices are quite complex in structure and can greatly increase the outer diameter of the staple cartridge assembly, and in practical use, the difficulty of the staple cartridge assembly entering the tissue can be increased due to the increase of the outer diameter of the staple cartridge assembly.

The utility model discloses in, distal end side and near-end side are for the operator, and the one end that is nearer apart from the operator is near-end side, and the one end far away apart from the operator, the one end that is more close to the operation position promptly is the distal end side. In the stapler, the inner side and the outer side are relative to the axis of the stapler, wherein the side close to the axis is the inner side, and the side far away from the axis is the outer side.

SUMMERY OF THE UTILITY MODEL

To the problem among the prior art, the utility model aims to provide a guide piece and tubular anastomat on the basis that does not basically increase nail storehouse subassembly external diameter, can guide nail storehouse subassembly to get into organize inside well to after nail storehouse subassembly reachs the operation position, the guide piece can easily break away from a nail section of thick bamboo distal end side.

The embodiment of the utility model provides a guide for the nail storehouse subassembly of circular tube type anastomat, nail storehouse subassembly includes the nail section of thick bamboo, the guide includes:

a guide body on a distal side of the cartridge, the guide body being helically wound from a flexible band and having an outer diameter less than an outer diameter of the distal side of the cartridge;

at least one connecting portion, a distal end side of the connecting portion being connected to the guide body, a proximal end side of the connecting portion being connected to an inside of the cartridge;

the lead body is spirally disintegrable into a ribbon-like structure when the lead body is subjected to a pulling force toward the proximal side.

Optionally, the guide body is asymmetric with respect to an axial direction of the cartridge, the proximal face of the guide body being at least partially moveable against the distal face of the cartridge.

Optionally, the proximal end face of the guide body has a smallest radius at which the connecting portion is located in a cross section parallel to the axial direction of the cartridge, and the connecting portion has a largest radius in the opposite direction, the smallest radius being larger than the radius of the inner wall of the cartridge, and the largest radius being equal to the radius of the outer wall of the cartridge.

Optionally, the connecting portion extends in an axial direction of the cartridge.

Optionally, the proximal side of the connecting portion forms a detachable connection with the inside of the cartridge.

Optionally, the nail cartridge assembly further comprises a nail pushing sheet located inside the nail cartridge, a buckle is formed at the proximal end side of the connecting portion, and the buckle is clamped between the inner side wall of the nail cartridge and the nail pushing sheet.

Optionally, a distal side of the connecting portion is connected to a proximal side of the guide body.

Optionally, a pull cord is included, the pull cord being connected to the distal side of the lead body.

Optionally, a surface of the guide body is at least partially coated with a lubricant.

Optionally, the guide further comprises a flexible outer sleeve, the outer sleeve covers the outer side surface of the guide body, and the outer sleeve is fixedly connected with the guide body.

Optionally, the proximal end side of the outer sleeve is detachably sleeved outside the nail barrel.

Optionally, the thickness of the portion of the outer sleeve sleeved on the distal end side of the nail barrel in the initial state is less than 0.1 mm.

Optionally, the portion of the outer sleeve that is sleeved on the distal side of the cartridge in the initial state is elastic.

Optionally, the outer surface of the outer jacket is at least partially coated with a lubricant.

The embodiment of the utility model provides a still provide a circular tube type anastomat, include the guiding piece.

The utility model provides a guide and circular tube type anastomat has following advantage:

the utility model provides a guide piece for circular tube type anastomat on the basis that does not basically increase nail storehouse subassembly external diameter, can guide nail storehouse subassembly well and get into inside organizing, protects the mucosa layer of stub tissue and tissue to after nail storehouse subassembly reachs the operation position, the guide piece can easily break away from nail section of thick bamboo distal end side, does not influence the operation and normally goes on, operation easy operation has improved operator's use and has experienced.

Drawings

Other features, objects and advantages of the invention will become more apparent from a reading of the following detailed description of non-limiting embodiments thereof, with reference to the accompanying drawings.

FIG. 1 is a schematic view of the first embodiment of the present invention showing the structure of the guide and cartridge assembly;

FIG. 2 is a sectional view taken along line A-A of FIG. 1;

FIG. 3 is a schematic view of the guide and cartridge assembly of a second embodiment of the present invention in combination;

fig. 4 is a sectional view taken along line B-B in fig. 2.

Reference numerals:

1 guide body 4 jacket

11 distal end side of the distal end side 41 sheath of the guide body

111 proximal side of the sleeve with openings 42

12 proximal side 7 cartridge of guide body

2 distal side of connecting part 71 cartridge

21 distal side of the connecting portion 72 proximal side of the cartridge

22 proximal side 73 window of the connection

Internal cavity of 3-way pull 74 nail barrel

31 pulling the distal end side 8 of the cord

32 proximal side of the pull cord

Detailed Description

Example embodiments will now be described more fully with reference to the accompanying drawings. Example embodiments may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the concept of example embodiments to those skilled in the art. The same reference numerals in the drawings denote the same or similar structures, and thus their repetitive description will be omitted.

The utility model provides a guide piece for circular tube type anastomat and circular tube type anastomat comprising the guide piece. The circular tube anastomat comprises an anastomat body, an operating handle movably connected with the anastomat body and a nail anvil assembly matched with the anastomat body. The anastomat body comprises a nail bin assembly arranged on the far end side. During operation, the nail bin assembly is required to enter the tissue and move forwards to reach the operation position. The guide is used to better guide the cartridge assembly into a surgical site.

Specifically, the guide includes: a guide body and at least one connecting portion. The guide body is used as a main body for guiding the nail box assembly and is positioned at the distal end side of the nail barrel. The guide body is helically formed around by a flexible band and has an outer diameter smaller than the outer diameter of the distal side of the cartridge, thereby not increasing the outer diameter of the cartridge assembly. The connecting portion is used for connecting the guide body to the cartridge, and has a distal end side connected to the guide body and a proximal end side connected to the inside of the cartridge. The guide body may be connected to a pull cord, and in an initial state, when the pull cord receives an external force toward the proximal end side, the pull cord may pull the guide body so that the guide body is spirally disassembled into a band-shaped structure, and may be separated from the distal end side of the cartridge to at least partially enter the inside of the cartridge, which is a disengaged state, thereby not affecting the firing of the stapler.

The structure of the guide according to various embodiments of the present invention will be described in detail with reference to the accompanying drawings, and it should be understood that the embodiments are not intended to limit the scope of the present invention.

As shown in fig. 1 and 2, the guide according to the first embodiment of the present invention is schematically shown. In this embodiment, the guide comprises a guide body 1, at least one connection 2 and a pull cord 3. The state of the guide is divided into an initial state and a disengaged state. In the initial state, the guide body 1 is located at the distal end side 71 of the cartridge 7, the guide body 1 is helically wound by a flexible band, and the outer diameter of the guide body 1 is smaller than the outer diameter of the distal end side 71 of the cartridge 7. Therefore, in the initial state, the guide body 1 can well guide the cartridge assembly entering the tissue, and because the outer diameter of the guide body 1 is smaller than the outer diameter of the distal end side 71 of the cartridge 7, the guide body 1 does not increase the outer diameter of the cartridge assembly, and does not increase extra obstruction to the movement of the cartridge assembly in the tissue.

The connecting part 2 is used for connecting the guide body 1 and the nail barrel 7. The distal side 21 of the connecting part 2 is connected to the guide body 1 and the proximal side 22 of the connecting part 2 is connected to the inside of the cartridge 7. The distal end side 31 of the pull cord 3 is connected to the distal end side of the lead body 1.

In the initial state, when the pull cord 3 receives an external force toward the proximal end side, the pull cord 3 may pull the guide body 1, so that the guide body 1 is spirally disassembled into a belt-shaped structure, and after the guide body 1 is spirally disassembled, the guide body may be separated from the distal end side 71 of the cartridge 7 by the pull cord 3 and at least partially enter the internal cavity 74 of the cartridge 7, and then the guide body is in a separated state. At this time, since the guide body 1 does not obstruct the distal end side of the cartridge 7, the normal cutting and stapling actions of the cartridge module are not affected, and the stapler can be fired normally.

In this embodiment, the distal side and the proximal side are relative to the operator, the end closer to the operator is the proximal side, the end farther from the operator, i.e. the end closer to the surgical site, is the distal side, and the direction along the axial center of the stapler is the axial direction, i.e. the direction from the distal side to the proximal side of the stapler, or the direction from the proximal side to the distal side of the stapler. For example, in the perspective of FIGS. 1 and 2, the distal side 71 is the upper side and the proximal side 72 is the lower side of the cartridge 7. The distal end side 11 of the guide body 1 is the upper side, and the proximal end side 12 is the lower side. In the present invention, for the nail barrel 7, the inside and the outside are relative to the axis of the nail barrel 7, the side close to the axis is the inside, and the side far away from the axis is the outside. In the guide body 1, the outer side and the inner side of the guide body 1 are relative to the axis of the staple cylinder 7, the side of the guide body facing the axis of the staple cylinder 7 is an inner side surface, and the side of the guide body facing away from the axis of the staple cylinder 7 is an outer side surface, namely, after the staple cartridge assembly enters the tissue, the side of the guide body 1 directly contacting the tissue is the outer side surface.

As shown in fig. 2, the connecting portion 2 extends along the axial direction of the cartridge 7, and can further serve as an axial support for the guide body 1, so as to prevent the guide body 1 from collapsing into the cartridge 7 in the initial state. In this embodiment, the distal side 21 of the connecting portion 2 may be connected to the proximal side 12 of the lead body 1. In other embodiments, the distal end 21 of the connecting portion 2 may also be connected to the distal end 11 of the lead body 1, or connected to the inner side surface of the lead body 1 at other positions, all falling within the scope of the present invention.

As shown in fig. 2, the guide body 1 is asymmetric with respect to the axial direction of the cartridge 7, and the end surface of the proximal end side 12 of the guide body 1 is at least partially movable in the circumferential direction against the end surface of the distal end side 71 of the cartridge 7. In particular, the end surface of the proximal side 12 of the guide body 1 has, in a cross section parallel to the axial direction of the cartridge 7 (i.e. corresponding to the cross section in fig. 2), the smallest radius r1 where the web 2 is located, the largest radius r2 in the direction opposite to the web 2, the smallest radius r1 being larger than the radius of the inner wall of the cartridge 7, and the largest radius r2 being equal to the radius of the outer wall of the cartridge 7, so that the guide body 1 is stably fixed to the distal side 71 of the cartridge 7, and circumferential coverage of the distal surface of the cartridge 7 is also achieved. Meanwhile, since the radius r1 where the joint part 2 is located is minimized, it is possible to reduce the resistance of the distal end side 71 end surface of the cartridge 7 against the guide body 1 and the joint part 2 when the guide body 1 is pulled into the cartridge 7, and to make the guide more smoothly pulled out of the cartridge 7 when the pull cord 32 is continuously pulled in the disengaged state.

In this embodiment, the proximal side 22 of the attachment portion 2 may form a detachable connection with the inside of the cartridge 7. Thus, even if the cord 3 is further pulled in the disengaged state, the guide body 1, the connecting portion 2, and the cord 3 can be completely pulled out of the cartridge 7 through the window 73 of the cartridge 7, which is the removed state. And the connecting portion 2 is preferably made of a flexible material which can be more easily removed from the cartridge 7. The removed state is not essential and the proximal side 22 of the coupling part 2 and the inside of the cartridge 7 may also form a fixed connection. The connecting portion 2 and the guide body 1 may be integrally formed, or may be two separate structures, and may be made of a silicone material, a plastic material, a rubber material, or the like, for example, TPE (Thermoplastic Elastomer, which is also called Elastomer or synthetic rubber).

In this embodiment, as shown in fig. 2, the cartridge module further comprises a nail pushing plate 8 located inside the nail barrel 7, and the proximal side 22 of the connecting part 2 forms a buckle which is clamped between the inner side wall of the nail barrel 7 and the nail pushing plate 8. In other alternative embodiments, the proximal side 22 of the coupling part 2 may be connected to the inside of the cartridge 7 in other ways than those shown here, for example, it is also possible to provide the inside wall of the cartridge 7 with a recess into which the proximal side 22 of the coupling part 2 is inserted, or to provide the inside wall of the cartridge 7 with a projection to which the proximal side 22 of the coupling part 2 is opened and connected, etc.

In this embodiment, the distal side 31 of the pull cord 3 is attached to the distal side 11 of the guide body 1 and the proximal side 32 of the pull cord 3 extends outwardly from the viewing window 73 of the cartridge 7. In particular, the distal end side 11 of the guide body 1 may be provided with an opening 111, at which opening 111 the distal end side 31 of the pull cord 3 is fixed. In an initial state, when the pull cord 3 receives an external force toward the proximal end side, the pull cord 3 may pull the guide body 1 so that the guide body 1 is gradually spirally disassembled into a band-like structure from the distal end side 11 to the proximal end side 12 thereof. In other alternative embodiments, the distal side 31 of the pull cord 3 may also be connected to the proximal side 12 of the lead body 1 such that when the pull cord 3 pulls the proximal side 12 of the lead body 1 towards the proximal side, the lead body 1 gradually spirals from its proximal side 12 towards the distal side 11 into a band-like structure. In addition, stay cord 3 can also connect in the medial surface of other positions of guide part body 1, the homoenergetic realizes the utility model discloses an aim. The windows of the stapler of the prior art are symmetrically arranged in plurality, and preferably, the pull rope 3 is arranged to protrude outwards from the window far from the connecting part 2, so as to realize better disintegration.

In this embodiment, the surface of the guide body 1 may be at least partially coated with a lubricant, thereby providing better guidance of the cartridge assembly into the tissue, reducing friction when the guide body 1 contacts the tissue surface, and reducing damage to the tissue. The lubricant may be an oil-based lubricant, a water-based lubricant, or the like, which is known in the art. For example, hydrophilic coating of the outer side surface of the guide body 1, and dipping of the surface of the guide body 1 with water before use, becomes very lubricious, and this technique has been widely used in the surgical field.

As shown in fig. 1 and 2, the distal side 11 of the guide body 1 has an outer diameter that is smaller than the outer diameter of the proximal side 12, thereby forming a tapered configuration that better guides the cartridge assembly into the tissue and further reduces the frictional forces that contact the guide body 1 with the tissue surface. In other alternative embodiments, it is also possible that the outer diameter of the distal side 11 of the guide body 1 is equal to the outer diameter of the proximal side 12, forming a cylindrical structure, and also falling within the scope of the present invention.

As shown in fig. 3 and 4, the structure of the guide according to the second embodiment of the present invention is schematically illustrated. This embodiment differs from the first embodiment in that: the guide further comprises a flexible outer sleeve 4, the outer sleeve 4 covers the outer side face of the guide body 1, and the outer sleeve 4 is fixedly connected with the guide body 1. In the initial state, the outer sleeve 4 and the guide body 1 together are located at the distal side 71 of the cartridge 7 and provide a guiding function for the cartridge assembly into the tissue. The outer sheath 4 may further reduce friction when the outer surface of the lead body 1 contacts the tissue surface, reducing tissue damage. After the cartridge assembly reaches the surgical site, the surgeon can pull the pull cord 3, first pull the guide body 1 to unscrew, and after the guide body 1 is disengaged from the distal end side 71 of the cartridge 7, the guide body 1 pulls the outer sleeve 4 together to move toward the proximal end side, so that the outer sleeve 4 at least partially enters the inner cavity 74 of the cartridge 7, and the disengaged state is achieved, and the normal operation is not affected. In the disengaged state, the pull cord 3 is further pulled, so that the guide body 1 and the outer sleeve 4 can be pulled out of the cartridge 7 together from the window 73, and at this time, the cartridge is in a removal state, but the removal state is not necessary, and after the guide body 1 and the outer sleeve 4 enter the internal cavity 74 of the cartridge 7, if the protrusion of the anvil pull rod and the movement of the staple pushing sheet are not blocked, the guide body 1 and the outer sleeve 4 do not need to be removed, and after the stapler is fired, the guide can be moved out of the tissue together with the cartridge assembly.

In this embodiment, the proximal side 42 of the outer sleeve 4 may be removably sleeved over the outside of the cartridge 7. Thus, the outer sleeve 4 not only protects the tissue, but also further strengthens the connection strength between the guide body 1 and the cartridge 7 in the initial state, in which the proximal side 42 of the outer sleeve 4 is fixed to the distal side 71 of the cartridge 7, thereby avoiding the separation of the guide body 1 from the distal side 71 of the cartridge 7 when the cartridge assembly moves in the tissue. The outer sleeve 4 may be connected to the proximal side 12 of the guide body 1, and the outer sleeve 4 may be pulled to the proximal side after the guide body 1 is spirally disassembled from the distal side 11 to the proximal side 12, and in other alternative embodiments, the outer sleeve 4 may also be connected to the distal side 11 of the guide body 1, or connected to other positions, all belonging to the protection scope of the present invention. In other alternative embodiments, the proximal side 42 of the outer sleeve 4 may extend further toward the proximal side 71 of the cartridge 7, e.g., the outer sleeve 4 may at least partially cover the viewing window 73 of the cartridge 7 to protect the side of the viewing window 73 from tissue contact.

As shown in fig. 3 and 4, since the proximal end side 42 of the outer sleeve 4 is sleeved on the outer side surface of the nail barrel 7, in order to reduce the influence on the outer diameter of the nail barrel 7, the outer sleeve 4 is preferably made of a thin film structure, such as a silicone film, a rubber film, a plastic film, and the like. The thickness of the part of the outer sleeve 4 that in the initial state is arranged on the distal side 71 of the cartridge 7 is preferably less than 0.1 mm, for example selected in the range of 0.01 mm to 0.1 mm. Thus, the outer sleeve 4 does not substantially increase the outer diameter of the cartridge assembly, and the load of the cartridge assembly entering the tissue due to the guide is not increased. In other alternative embodiments, the thickness of the sheath 4 may be selected within other ranges, and is not limited to the numerical ranges set forth herein. In other alternative embodiments, the sheath 4 may be made of a flexible fabric, such as a woven fabric, a knitted fabric, etc., the material used for the fabric may be a rayon material or a spun yarn obtained by a polymer extrusion method, etc., and the sheath 4 is preferably made of an elastic fabric.

The portion of the outer sleeve 4 that is sleeved on the distal side 71 of the cartridge 7 in the initial state, in which the proximal side 42 of the outer sleeve 4 is in the expanded state to tighten the cartridge 7, may be elastic, avoiding an accidental detachment of the guide when the cartridge assembly has not reached the surgical site.

In order to further improve the guiding effect of the guide on the cartridge assembly and to reduce the friction between the guide surface and the tissue surface, the outer surface of the outer sleeve 4 may be at least partially coated with a lubricant, thereby reducing the damage to the tissue when the cartridge assembly is moved in the tissue. The lubricant may be an oil-based lubricant or an aqueous-based lubricant, etc. of the prior art. For example, hydrophilic coating of the outer surface of the jacket 4, which becomes very lubricious when the jacket 4 is dipped in water before use, has been widely used in the surgical field.

The guide piece provided by the utility model can be independently placed and not mounted on the nail barrel part of the anastomat before being used, and can be selectively mounted by a user according to the needs, the operation is simpler, only the guide piece needs to be mounted on the far-end side 71 of the nail barrel 7, and in some embodiments, the outer sleeve 4 needs to be sleeved on the far-end side 71 of the nail barrel 7; can also be directly arranged on the nail barrel part of the anastomat without being arranged by the user.

The foregoing is a more detailed description of the present invention, taken in conjunction with the specific preferred embodiments thereof, and it is not intended that the invention be limited to the specific embodiments shown and described. To the utility model belongs to the technical field of ordinary technical personnel, do not deviate from the utility model discloses under the prerequisite of design, can also make a plurality of simple deductions or replacement, all should regard as belonging to the utility model discloses a protection scope.

Claims

1. A guide, characterized by a cartridge assembly for a circular tube-type stapler, the cartridge assembly including a cartridge, the guide comprising:

2. The guide of claim 1, wherein the guide body is asymmetrical with respect to an axial direction of the cartridge, a proximal face of the guide body being at least partially movable against a distal face of the cartridge.

3. The guide of claim 2, wherein the proximal end surface of the guide body has a smallest radius at which the connecting portion is located in a cross-section taken parallel to an axial direction of the cartridge, and wherein the connecting portion has a largest radius in a direction opposite thereto, the smallest radius being larger than a radius of an inner wall of the cartridge, and the largest radius being equal to a radius of an outer wall of the cartridge.

4. The guide of claim 1, wherein the connecting portion extends in an axial direction of the cartridge.

5. The guide of claim 1, wherein a proximal side of the connecting portion forms a detachable connection with an inside of the cartridge.

6. The guide of claim 1, wherein the cartridge assembly further comprises a staple pusher within the cartridge, the proximal side of the connecting portion forming a catch that is captured between an inner sidewall of the cartridge and the staple pusher.

7. The guide of claim 1, wherein a distal side of the connecting portion is connected to a proximal side of the guide body.

8. The guide of claim 1, further comprising a pull cord connected to the distal side of the guide body.

9. The guide of claim 1, wherein a surface of the guide body is at least partially coated with a lubricant.

10. The guide of claim 1, further comprising a flexible outer sleeve covering an outer side of the guide body, wherein a proximal side of the outer sleeve is removably sleeved over an outer side of the cartridge and the outer sleeve is fixedly coupled to the guide body.

11. The guide of claim 10, wherein the portion of the sheath that is sleeved on the distal side of the cartridge in the initial state has a thickness of less than 0.1 mm.

12. The guide of claim 10, wherein the portion of the sheath that is disposed on the distal side of the cartridge in the initial state is resiliently expandable.

13. The guide of claim 10, wherein an outer surface of the outer jacket is at least partially coated with a lubricant.

14. Circular tube-type anastomat, characterized in that it comprises a guide according to any one of claims 1 to 13.