An implant, delivery system and bladder management system

Abstract

The application discloses an implant, a delivery system and a bladder management system, the implant comprises a first end, a tube body and a second end which are sequentially communicated from a distal end to a proximal end, the first end is provided with an anchoring device and a first locking seat for detachable connection with the delivery system, the anchoring device is expanded when the first locking seat is pulled by the delivery system; the second end is provided with a magnetic control valve for controlling opening and closing of the second end, the magnetic control valve comprises a first magnetic element, a blocking piece and a second magnetic element which are sequentially arranged along an axial direction, the blocking piece is provided with a first through hole which is axially penetrated, the first magnetic element and the second magnetic element block the first through hole when they are attracted to each other, and the first magnetic element and the second magnetic element open the first through hole when they are separated from each other under the action of an external magnetic field. The self-sealing success rate is improved, and the liquid leakage probability in the use process is reduced. The implant and the delivery system can be artificially fixed and loosened, and the operation process is safe and reliable.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to an implant, a delivery system and a bladder management system. BACKGROUND

[0002] A urinary catheter is a device inserted into the urethra to drain urine into the bladder, which is widely used in patients with urinary retention or bladder outlet obstruction, patients with urinary incontinence, etc. At present, most urinary catheters in the prior art are Foley urinary catheters (catheter with balloon) implanted partially in the body and partially exposed to the outside of the body, and are used in combination with a urine bag. However, such urinary catheters have the following problems: ① The catheter exposed to the outside of the body can easily cause urinary tract infection; ② Carrying a urine bag limits the normal work and social life of the patient, and many activities cannot be carried out.

[0003] To solve the above problems, the urinary catheter can be completely implanted into the urethra, the device can be delivered to the desired position by a delivery system, and the implanted part and the delivery system can be separated. However, the prior art has the following problems: the sealing effect of the urinary catheter is poor, there is a high probability of liquid leakage; the reliability of the fixing method of the distal end of the delivery system and the distal end of the urinary catheter is low, and it is easy to loosen; the valve of the urinary catheter is easily corroded, and the service life is short. SUMMARY

[0004] The purpose of the present application is to provide an implant, a delivery system and a bladder management system, which improve the sealing effect of the implant and reduce the probability of liquid leakage during use.

[0005] To achieve the above purpose, the technical solution adopted by the present application is to provide an implant, which comprises a first end portion, a tube body and a second end portion sequentially communicated from the distal end to the proximal end, the first end portion has an anchoring device and a first locking seat for detachable connection with a delivery system, the anchoring device is expanded when the first locking seat is pulled by the delivery system; the second end portion is provided with a magnetic control valve for controlling the opening and closing of the second end portion, the magnetic control valve sequentially comprises a first magnetic element, a blocking piece and a second magnetic element along the axial direction, the blocking piece has an axial first through hole, the first magnetic element and the second magnetic element block the first through hole when they attract each other, and the first magnetic element and the second magnetic element open the first through hole when they move away from each other under the action of an external magnetic field.

[0006] Preferably, the first locking seat is tubular and fixed in the first end portion, and a cross beam for connecting with the delivery system is arranged in the lumen of the first locking seat.

[0007] Preferably, the tube wall of the first locking seat is provided with a step.

[0008] Preferably, a limiting structure is arranged on the tube body or the magnetic control valve to limit the entry of the first magnetic element into the tube body.

[0009] Preferably, the inner diameter of the tube body is smaller than the outer diameter of the first magnetic element.

[0010] Preferably, both ends of the first through hole are funnel-shaped, and the first magnetic element and the second magnetic element are both magnetic beads.

[0011] Preferably, the second end portion is provided with a second locking seat in the form of a sleeve fixed to the inner wall of the second end portion, and the sealing member is fixed to the second locking seat.

[0012] Preferably, a limiting member is arranged on one side of the proximal end of the second locking seat, the limiting member has a second through hole axially penetrating, the second through hole and the first through hole form a channel for the delivery system to pass through in the axial direction, and the distance between the limiting member and the other side of the proximal end of the second locking seat is smaller than the outer diameter of the second magnetic element.

[0013] Preferably, the outer surface of the first magnetic element and the second magnetic element is wrapped with a soft film.

[0014] To achieve the above-mentioned purpose, another technical solution adopted by the present application is to provide a delivery system of an implant, comprising a delivery tube, a fixing member and a flexible and elongated locking component, the distal end of the delivery tube is detachably connected with the second end portion, the proximal end of the delivery tube is connected with the fixing member, the locking component is arranged in the tube body and the delivery tube, and the first locking seat and the fixing member are detachably connected through the locking component.

[0015] Preferably, one end of the locking component is fixedly connected with the fixing member, and the other end of the locking component passes through the first locking seat and is detachably connected with the fixing member.

[0016] Preferably, the fixing member is a compression device or a rotating device.

[0017] Preferably, the delivery system further comprises a locking sleeve, the locking sleeve is arranged in the tube body and the delivery tube, the distal end of the locking sleeve is connected with the first locking seat, the proximal end of the locking sleeve is connected with the proximal end of the delivery tube, and the locking component is arranged in the locking sleeve.

[0018] Preferably, the distal end of the delivery tube and the second end portion are connected through a connecting member, the connecting member comprises a connecting hook detachably connected with the limiting member on the second end portion, and a third through hole axially penetrating for the locking sleeve to pass through.

[0019] Preferably, the conveying system further includes a male plug, a locking cap, and a male head, the proximal end of the locking sleeve is connected to the male plug, the male plug is detachably connected to the proximal end of the conveying pipe through the locking cap, the distal end of the male head is connected to the proximal end of the male plug, and the proximal end of the male head is detachably connected to the fixing member.

[0020] To achieve the above objectives, the present invention also provides a bladder management system, including the above-described implant and the above-described delivery system.

[0021] Compared with existing technologies, the present invention offers the following advantages: The implant, delivery system, and bladder management system provided by the present invention, through the dual magnetic elements of a magnetically controlled valve at the second end, endow both sides of the sealing component with sealing capability, improving the self-sealing success rate and reducing the probability of leakage during use. In particular, the soft film coating around the magnetic elements further improves the self-sealing success rate and reduces the probability of leakage during use, while preventing defects caused by urine corrosion of the magnet inside the tube, thus extending the service life of the magnetically controlled valve. By setting a first locking seat, locking component, locking sleeve, and connector, the implant and delivery system can be manually fixed and released, with a safety locking protection design to improve the safety of the surgical procedure; enabling the implant to be inserted into the body and the delivery system to be retrieved. Attached Figure Description

[0022] Figure 1 This is a schematic diagram of the overall structure of the bladder management system in an embodiment of the present invention;

[0023] Figure 2 a is a schematic diagram of the overall structure of the implant in an embodiment of the present invention. Figure 2 b is Figure 2 A cross-sectional view of a;

[0024] Figure 3 This is a schematic diagram of the structure of the second end in an embodiment of the present invention;

[0025] Figure 4 a is a schematic diagram of the overall structure of the conveying system in an embodiment of the present invention. Figure 4 b is Figure 4 A cross-sectional schematic diagram of a Figure 4 c is Figure 4 A magnified view of a portion of point A in section a; Figure 4 d is Figure 4 A magnified view of a portion of point B in b;

[0026] Figure 5 a is a schematic diagram of locking the first end of the implant in an embodiment of the present invention. Figure 5 b is Figure 5 A magnified view of point C in section a. Figure 5 c is Figure 5a. A perspective view of the first locking seat at C in the implant;

[0027] Figure 6 A locking view of the second end of the implant in the embodiment of the present application.

[0028] In the figure:

[0029] 1-implant, 2-delivery system, 3-first end, 4-first locking seat, 5-shaft, 6-second end,

[0030] 7-magnetic valve, 8-first magnetic element, 9-plug, 10-second magnetic element, 11-second locking seat, 12-locking part, 13-locking sleeve, 14-connector, 15-delivery tube, 16-male plug, 17-male, 18-locking cap, 19-fastener, 20-back cover, 21-limiting part, 31-anchoring device, 41-cross beam, 42-first sleeve, 43-second sleeve, 91-first through hole, 141-third through hole, 142-connection hook, 211-second through hole. DETAILED DESCRIPTION

[0031] The present application will be further described below in conjunction with the drawings and examples.

[0032] It should be noted that the terms "inner", "outer", "upper", "lower" and similar expressions used in the present application are only for the purpose of illustration and do not represent the only embodiment. The present application uses "distal", "proximal" and "axial", "distal" is the side away from the operator of the delivery system; "proximal" is the side close to the operator of the delivery system; "axial" refers to the direction along the axis of the implant shaft.

[0033] Please refer to Figure 1 The bladder management system provided by the embodiment comprises an implant 1 and a delivery system 2. The implant 1 is an internal device, which is a magnetic control catheter implanted in the body. After the delivery system 2 delivers the implant 1 to the desired position, the implant 1 and the delivery system 2 are separated.

[0034] Please refer to Figure 2 and Figure 3The implant 1 provided by the embodiment comprises, from the distal end to the proximal end, a first end portion 3, a tube body 5 and a second end portion 6 which are sequentially communicated, the first end portion 3 is provided with an anchoring device 31 and a first locking seat 4 for detachable connection with a delivery system 2, the anchoring device 31 is expanded when the first locking seat 4 is pulled by the delivery system 2; the second end portion 6 is provided with a magnetic control valve 7 for controlling the opening and closing of the second end portion 6, the magnetic control valve 7 comprises, along the axial direction, a first magnetic element 8, a blocking piece 9 and a second magnetic element 10 in sequence, the blocking piece 9 is provided with a first through hole 91 which is axially penetrated, when there is an external magnetic field, the first magnetic element 8 and the second magnetic element 10 of the magnetic control valve 7 will simultaneously move away from the first through hole 91, the first through hole 91 is opened, and the valve is opened; when the external magnetic field is removed, the first magnetic element 8 and the second magnetic element 10 are attracted to each other, so that the first magnetic element 8 and the second magnetic element 10 are pressed against the blocking piece 9, the first through hole 91 is blocked, and the valve is closed. Since the two sides of the blocking piece 9 are pressed by the magnetic elements in the axial direction, the two sides of the blocking piece 9 have sealing effect, so that the overall sealing performance is improved, and the probability of liquid leakage during use is reduced. The anchoring device 31 is in a contracted state when the implant 1 is implanted into the human body and taken out, after the implant 1 is implanted into the human body, the anchoring device 31 is expanded under the control of the delivery system 2, so as to fix the implant 1 in the human body, liquid flows from the first end portion 3, passes through the tube body 5, and flows out from the second end portion 6, the magnetic control valve 7 of the second end portion 6 controls the discharge of the liquid.

[0035] Please refer to Figure 5a-5c, in a specific embodiment, the first locking seat 4 is tubular, further, the tubular wall of the first locking seat 4 is provided with a step, specifically, the step is composed of a first sleeve 42 with a larger diameter and a second sleeve 43 with a smaller diameter, the step of the first locking seat 4 is clamped in the first end part 3, further, the contact part between the first locking seat 4 and the first end part 3 is coated with an adhesive to enhance the connection strength, so that the first locking seat 4 and the first end part 3 have sufficient connection strength and will not separate under the application of external force during operation; a cross beam 41 for connecting with the delivery system 2 is arranged in the first sleeve 42 at the distal end, for the locking member 12 to pass through and be fixed for use, the second sleeve 43 at the proximal end is in clearance fit with the locking sleeve 13, so that the distal end of the locking sleeve 13 is fixed in the second sleeve 43. Preferably, the anchoring device 31 is integrated with the tube body 5 and is made of soft material such as silica gel, etc., and the anchoring device 31 is in a hollow half-open state in the original state. When implanted in the human body, the tube body 5 is moved to the distal end in the urethra by the delivery system 2, the pressure of the urethra on the anchoring device 31 makes it contract, after the implant 1 enters the bladder, the anchoring device 31 releases to the original half-open state, and the anchoring device 31 is adjusted by pulling the locking member 12 to fully open, so as to fix the implant 1 in the human body. The anchoring device 31 can be any expandable and contractible structure, and in other embodiments, it can be umbrella-shaped, capsule-shaped, etc., which are not particularly limited in the present application.

[0036] Please continue to see Figure 3 , further, the inner diameter of the tube body 5 is smaller than the outer diameter of the first magnetic element 8, to prevent the first magnetic element 8 from leaving the second end part 6 and entering the tube body 5, or, a limiting structure is arranged on the tube body 5 or the magnetic control valve 7 to limit the entry of the first magnetic element 8 into the tube body 5, to prevent the first magnetic element 8 from leaving the second end part 6 and entering the tube body 5, which can be a limiting protrusion, baffle, etc. arranged on the tube body 5 or the magnetic control valve 7; the proximal end of the second end part 6 is provided with a second locking seat 11, preferably, the second locking seat 11 is sleeve-shaped and is made of hard material, the proximal end and the distal end of the second locking seat 11 are fixed to the inner wall of the second end part 6 through matching protrusions and grooves, further, the contact part between the second locking seat 11 and the inner wall of the second end part 6 is coated with an adhesive to enhance the connection strength, so that the second locking seat 11 and the second end part 6 have sufficient connection strength and will not separate under the application of external force during operation. The obturator 9 is fixed on the second locking seat 11, the first magnetic element 8 and the second magnetic element 10 are preferably magnetic beads, preferably, the two ports of the first through hole 91 are funnel-shaped, the funnel-shaped structure plays a guiding role, when it is necessary to close the valve, the magnetic beads can be guided to roll to the first through hole 91, so as to ensure that the magnetic control valve 7 can be successfully closed each time.

[0037] The side wall of the proximal end of the second locking seat 11 is provided with a limiting piece 21, the distance between the limiting piece 21 and the other side wall of the proximal end of the second locking seat 11 is less than the outer diameter of the second magnetic element 10, so as to prevent the second magnetic element 10 from falling out of the proximal end of the second end 6, and the limiting piece 21 is provided with a second through hole 211 which is axially through, and the second through hole 211 and the first through hole 91 form a channel in the axial direction, and the locking sleeve 13 can pass through. Furthermore, the outer surfaces of the first magnetic element 8 and the second magnetic element 10 are wrapped with soft corrosion-resistant films. Since the urine environment has a certain corrosion effect on the first magnetic element 8 and the second magnetic element 10, after corrosion, there will be defects such as recesses or protrusions on the surface of the magnetic elements, which will reduce the sealing effect; therefore, the films can protect the magnetic elements from urine corrosion and prolong the service life of the magnetic valve 7; in addition, the soft films improve the sealing effect between the first magnetic element 8 and the second magnetic element 10 and the blocking piece 9, and further reduce the probability of liquid leakage.

[0038] Please refer to Figure 4 a- Figure 4 d, the delivery system 2 provided by the embodiment includes a connecting piece 14, a delivery tube 15, a fixing piece 19 and a flexible and elongated locking component 12, the distal end of the delivery tube 15 is detachably connected with the second end 6, the proximal end of the delivery tube 15 is connected with the fixing piece 19, the locking component 12 is arranged in the tube body 5 and the delivery tube 15, and the first locking seat 4 and the fixing piece 19 are detachably connected through the locking component 12. The locking component 12 can be an elongated strip-shaped material such as a wire or a rope; one end of the locking component 12 is fixedly connected with the fixing piece 19, and the other end of the locking component 12 passes through the first locking seat 4 and is detachably connected with the fixing piece 19.

[0039] Further, the delivery system 2 further includes a locking sleeve 13, the locking sleeve 13 is arranged in the tube body 5 and the delivery tube 15, the distal end of the locking sleeve 13 is connected with the first locking seat 4, the proximal end of the locking sleeve 13 is connected with the proximal end of the delivery tube 15, and the locking component 12 is arranged in the locking sleeve 13. The locking sleeve 12 not only provides a channel for the locking component 12, but also has a certain rigidity, and plays a supporting role on the tube body 5 when the implant 1 is delivered. The distal end of the delivery tube 15 is connected with the second end 6 through the connecting piece 14; the connecting piece 14 includes a connecting hook 142 which is detachably connected with the limiting piece 21 on the second end 6, and a third through hole 141 which is axially through and through which the locking sleeve 13 passes.

[0040] In one embodiment, the delivery system 2 further comprises a male plug 16, a male head 17, a locking cap 18 and a back cover 20, the proximal end of the locking sleeve 13 is connected with the male plug 16, the male plug 16 is detachably connected with the proximal end of the delivery tube 15 through the locking cap 18, the distal end of the male head 17 is connected with the proximal end of the male plug 16, the proximal end of the male head 17 and the distal end of the fixing member 19 are detachably connected, the proximal end of the fixing member 19 is connected with the back cover 20, the back cover 20 plays a role of fixing and protecting the fixing member 19 and facilitates operation. When the locking cap 18 is screwed, the male plug 16 is locked and connected with the delivery tube 15, when the locking cap 18 is unscrewed, the male plug 16 and the delivery tube 15 are separated, so that the locking sleeve 13 can be pulled out; the proximal end of the male head 17 and the distal end of the fixing member 19 are threadedly connected, when screwed, the two are fixed, when unscrewed, the male head 17 and the fixing member 19 are separated, and the fixing member 19 can pull out the locking member 12.

[0041] Please refer to Figure 4 a-4d, Figure 5 a-5c, in the bladder management system comprising the implant 1 and the delivery system 2, after the locking member 12 passes the crossbeam 41 of the first locking seat 4, both ends of the locking member 12 are inserted from the distal end of the locking sleeve 13, the distal end of the locking sleeve 13 is gap-fitted with the first locking seat 4, after the locking member 12 is inserted from the proximal end of the locking sleeve 13, one end of the locking member 12 is fixed on the fixing member 19, and the other end is detachably connected with the fixing member 19. The fixing member 19 can be a pressing device or a screwing device. The first locking seat 4 is fixed in the second end portion 3 of the implant 1 and will not be separated under the action of external force during operation, so as to fix the distal end of the implant 1 with the delivery system 2 and ensure that the implant 1 and the delivery system 2 will not be accidentally separated during the operation. When it is needed to be separated, the fixing member 19 is loosened to release the end of the locking member 12 which is detachably connected with the fixing member 19, the other end of the locking member 12 is still fixed on the fixing member 19, then the fixing member 19 is pulled towards the proximal end, so that the locking member 12 is pulled out, and the distal end of the implant 1 and the delivery system 2 are unlocked.

[0042] Please refer to Figure 6When the connecting piece 14 is inserted into the second locking seat 11 and matched with the limiting piece 21, the inner cavity of the delivery tube 15, the third through hole 141, the second through hole 211, the first through hole 91 and the inner cavity of the tube body 5 form a channel for the locking sleeve 13 to pass through; the locking sleeve 13 passes through the second locking seat 11 and continues to pass through the connecting piece 14, so that the second locking seat 11 and the connecting piece 14 are kept connected. The connecting piece 14 is connected with the distal end of the delivery tube 15 and also has sufficient connection strength, so that the connecting piece 14 will not be separated under the action of an external force during operation, thereby fixing the proximal end of the implant 1 to the delivery system 2 and ensuring that the implant 1 will not be separated accidentally during the operation. When it is needed to separate, the locking cap 18 is unscrewed, the locking sleeve 13 is pulled out, the limiting of the second locking seat 11 and the connecting piece 14 is released, and finally the delivery tube 15 is pulled out, so that the locking of the proximal end of the implant 1 to the delivery system 2 is released.

[0043] After the delivery system 2 implants the implant 1 in the body, the delivery system 2 releases the implant 1 in the following steps: the locking cap 18 is loosened, the male plug 16 is separated from the delivery tube 15, the locking part 12 is pulled to the proximal end, the anchoring device 31 at the distal end of the implant 1 is expanded, and the implant 1 is fixed in the body; after the position of the implant 1 is adjusted, the fixing part 19 is loosened, the male plug 17 is unscrewed, the male plug 17 is separated from the fixing part 19, the fixing part 19 is pulled to the proximal end, the locking part 12 is pulled out of the locking sleeve 13; then the male plug 17 is pulled to the proximal end and the locking sleeve 13 is pulled out; finally, the connecting piece 14 is detached, the implant 1 is separated from the delivery tube 15, and the delivery tube 15 is taken out, so that the release of the implant 1 is completed and the delivery system 2 is recycled.

[0044] In summary, the implant, the delivery system and the bladder management system provided by the application give both sides of the blocking piece sealing ability through the double magnetic elements of the magnetic valve arranged at the second end, improve the self-sealing success rate and reduce the liquid leakage probability during use. Especially, the magnetic elements are wrapped with soft film, which further improves the self-sealing success rate, reduces the liquid leakage probability during use, prevents defects caused by corrosion of the magnet in the tube by urine and improves the service life of the magnetic valve. Through the first locking seat and the locking part, the second locking seat and the connecting piece and the locking sleeve, the implant and the delivery system can be artificially fixed and loosened, a safety lock is designed, the safety of the operation process is improved, and the catheter implant is implanted in the body and the delivery system is taken back.

[0045] Although the application has been disclosed with the preferred embodiments as above, the application is not intended to be limited thereto, and any person skilled in the art can make some modifications and improvements without departing from the spirit and scope of the application, so the protection scope of the application should be defined by the claims.

Claims

1. An implant, characterized in that, The application relates to a delivery system, which comprises a first end part, a tube body and a second end part which are sequentially communicated from a distal end to a proximal end, the first end part is provided with an anchoring device and a first locking seat for detachable connection with a delivery system, the anchoring device is expanded when the first locking seat is pulled by the delivery system, the first locking seat is in a tubular shape and is fixed in the first end part, a crossbeam for connection with the delivery system is arranged in the lumen of the first locking seat, a locking part is arranged around the crossbeam and is fixed for use, the locking part is in an elongated strip shape; one end of the locking part is fixedly connected with a fixing part, the other end of the locking part passes through the first locking seat and is detachably connected with the fixing part; the second end part is provided with a magnetic control valve for controlling the opening and closing of the second end part, the magnetic control valve sequentially comprises a first magnetic element, a blocking part and a second magnetic element along an axial direction, the blocking part is provided with a first through hole which is axially penetrated, the first magnetic element and the second magnetic element block the first through hole when they are attracted to each other, and the first magnetic element and the second magnetic element open the first through hole when they are separated from each other under the action of an external magnetic field.

2. The implant of claim 1, wherein, The tube wall of the first locking seat is provided with a step.

3. The implant of claim 1, wherein, The tube body or the magnetic control valve is provided with a limiting structure for limiting the first magnetic element from entering the tube body.

4. The implant of claim 1, wherein, The inner diameter of the tube body is smaller than the outer diameter of the first magnetic element.

5. The implant of claim 1, wherein, The openings of the first through hole at both ends are in a funnel shape, and the first magnetic element and the second magnetic element are both magnetic beads.

6. The implant of claim 1, wherein, The second end part is provided with a second locking seat, the second locking seat is in a sleeve shape and is fixed to the inner wall of the second end part, and the blocking part is fixed to the second locking seat.

7. The implant of claim 6, wherein, The side tube wall of the proximal end of the second locking seat is provided with a limiting part, the limiting part is provided with a second through hole which is axially penetrated, the second through hole and the first through hole form a channel for the delivery system to pass through in an axial direction, and the distance between the limiting part and the other side tube wall of the proximal end of the second locking seat is smaller than the outer diameter of the second magnetic element.

8. The implant of claim 1, wherein, The outer surfaces of the first magnetic element and the second magnetic element are both wrapped with soft films.

9. A delivery system for the implant of any one of claims 1-8, wherein, The delivery system comprises a delivery tube, a fixing part and a flexible and elongated locking part, the distal end of the delivery tube is detachably connected with the second end part, the proximal end of the delivery tube is connected with the fixing part, the locking part is arranged in the tube body and the delivery tube, and the first locking seat and the fixing part are detachably connected through the locking part.

10. The delivery system of claim 9, wherein, The fixing part is a pressing device or a rotating device.

11. The delivery system of claim 9, wherein, The delivery system further comprises a locking sleeve, the locking sleeve is arranged in the tube body and the delivery tube, the distal end of the locking sleeve is connected with the first locking seat, the proximal end of the locking sleeve is connected with the proximal end of the delivery tube, and the locking part is arranged in the locking sleeve.

12. The delivery system of claim 11, wherein, The distal end of the delivery tube and the second end part are connected through a connecting part, the connecting part comprises a connecting hook which is detachably connected with the limiting part on the second end part and a third through hole which is axially penetrated and through which the locking sleeve passes.

13. The delivery system of claim 11, wherein, The delivery system further comprises a male plug, a locking cap and a male head, the proximal end of the locking sleeve is connected with the male plug, the male plug is detachably connected with the proximal end of the delivery tube through the locking cap, the distal end of the male head is connected with the proximal end of the male plug, and the proximal end of the male head is detachably connected with the fixing member.

14. A bladder management system characterized by, An implant according to any one of claims 1-8 and a delivery system according to any one of claims 9-13.

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