JP4624466B2 - Apparatus and method for vascular graft or stent graft delivery and fixation at both ends - Google Patents

Description

  This application includes Patent Cooperation Treaty (“PCT”) patent application PCT / IL / 000115 filed on February 1, 2005, and PCT / IL2005 / 001217 filed on November 17, 2005, And the Israel continuation patent application IL166648 filed on February 1, 2005, IL168893 filed on June 16, 2005, and IL170003 filed on August 1, 2005. .

  All our previous patent applications relate to medicine, specifically vascular surgery. IL166648 filed on February 1, 2005, IL168993 filed on June 2, 2005, IL169210 filed on June 16, 2005, and IL170003 filed on August 1, 2005 All our previous patent applications other than No. 1 include surgical procedures for the supply of blood vessels, essentially vascular grafts or stent grafts inside the aorta, as well as disease treatments such as aortic aneurysms. Devices and methods for their suturing by one end that make it possible to achieve are described. These methods and devices make it possible to prevent aortic aneurysm rupture by positioning and suturing a synthetic prosthesis-graft or stent-graft within the aorta. Patent application IL166648, filed February 1, 2005, IL168993, filed June 2, 2005, and IL170003, filed August 1, 2005, include implants or stents within the aorta. An apparatus and method for implant delivery and their alternate method with both ends is described. All these devices and methods were developed based on the prior art and background described in detail in our above mentioned PCT and Israel patent applications.

  At the same time, when performing surgery to prevent rupture of the aorta, particularly the abdominal aorta, and to clean calcium patches and other thrombus deposits from blood vessels using a “Rotabaster” type device When performing a surgical procedure, to prevent the formation of new thrombus and deposits, specifically, about 0.1 mm or less—thin wall that can be deployed over the inner surface of the washed vessel Or it is appropriate to apply an ultra-thin wall graft. This is to supply a thin-walled graft inside the blood vessel, suture the graft by one end, stretch or deploy it along the vessel lumen, and suture the graft by its second end. To raise the problem of continuously performing the necessary steps.

  It is an object of the present invention to develop a new method and apparatus that provides for the delivery and bilateral fixation of a grafted endovascular prosthesis-graft or stent graft into the corresponding vessel.

  Another object of the present invention is intended to perform a surgical procedure adapted to the anthropometric conditions of a specific patient and supplying a specific type and size of a graft or stent-graft and the latter end fixation to the vessel wall. It is to develop a system of devices that can be assembled from a kit of standardized parts (similar to a children's assembly kit) that allows the device to be assembled quickly.

  The third object of the present invention is to develop a new method of endovascular thin wall graft deployment and fixation of both ends to the vessel wall.

  The subject of the present invention is an apparatus and method for the delivery and fixation of endovascular grafts or stent grafts to the vessel wall. The proposed device comprises a tubular body and a cartridge intended for placement of fastener means and comprises means for securing the end of the endovascular graft or stent graft onto these heads 2 And a control mechanism including two control modules coupled together via connecting means.

  The device tubular body is configured for positioning within the tube. The tubular body is rigid in the longitudinal direction and flexible in the lateral direction, with two working heads at one end and a control mechanism at the second end.

  The device has two expandable actuation heads, each comprising a cartridge intended for the arrangement of fastener means. These actuating heads are located at the free ends of the tubular body and are expandable to maintain both ends of the delivered graft or stent-graft in contact with the endovascular surface at the moment of their mutual fixation. Is done.

  Each of the two working heads includes a group of cartridges comprising substantially eight cartridges incorporated into the corresponding working head structure. All cartridges are integrated and replaceable, each of these cartridges being intended for the arrangement of at least two fastener means. All of the cartridges therein have a progressive motion therein, to form fastener means during their extension from these cartridges, as well as to store and deliver standby fastener means. Means for holding the fastener means. Both actuating heads also comprise means for securing the end of the endovascular graft thereon.

  The proposed control mechanism of the device comprises a first control module and a second control module which are coupled together via connecting means. The control mechanism is disposed on the tubular bodies opposite the working heads and is associated with these working heads via the tubular bodies. A first control module is disposed at the free end of the tubular body and a second control module is disposed on the tubular body near the first module between the first module and the second expandable actuation head. The first control module serves for operation of the first working head, and the second control module serves for operation of the second working head. The control modules are coupled together on the tubular body via connecting means arranged between them.

  The proposed device has two embodiments. In a first embodiment, the device can be used for endovascular graft or stent graft delivery and bilateral fixation. The control mechanism of the device has a rigid fixation of the modules to each other.

  In a second embodiment, the device can be used for delivery, deployment, and bilateral fixation of thin wall endovascular grafts. For this purpose, the second working head is spaced a distance from the first working head, aligned with the first working head, fixed near the free end of the tubular body, and reciprocable therewith. A connecting means arranged on the tubular body between the first and second control modules can provide reciprocation of the second control module relative to the first control module and a second working head rigidly attached thereto; It is. As a result, surgery can be performed for thin wall graft delivery, deployment within the blood vessel, and fixation of its ends from inside the aorta to the blood vessel, substantially the wall of the aortic wall.

  The first expandable actuating head comprises a first pressure bushing, first and second bearing bushings arranged sequentially from the free end of the actuating head one after another and in alignment with the tubular body, and A first axial tube is rigidly connected to the first bearing bush and passes through a through axial hole in the second bearing bush.

  The first expandable actuating head is pivotally connected to a bearing lever pivotally fixed on the first bearing bush by one end thereof and pivotally mounted on the second bearing bush by their other end. Eight cartridges are provided.

  The second expandable working head, which is arranged at a distance from the first working head, is successively arranged starting from the free end of this working head facing the first expandable working head. Includes third and fourth bearing bushings and a second pressure bushing. The second head also has a second axial tube rigidly connected to the third bearing bush and passing through a through axial hole in the fourth bearing bush and in the second pressure bush. The third and fourth bearing bushes and the second pressure bushing are aligned with the tubular body. The second working head is pivotally connected with a bearing lever pivotally connected by its one end to the fourth bearing bush and pivotally mounted on the third bearing bush by their other end. A cartridge is also provided.

  The first and second actuating heads are disposed on the bearing levers and are substantially shaped as a radial tongue disposed on one of the ends of these bearing levers, the supplied implant or stent Means are provided for securing the implants near their pivot connection with the corresponding cartridge.

  Each of the cartridges includes at least one basic fastener means—means for holding a substantially U-shaped staple therein. The means for holding is disposed along the cartridge and substantially includes a sliding lid.

  Each of the device cartridges includes fastener means-at least one means for imparting a progressive motion to the substantially U-shaped staple, the means being longitudinally rigid and laterally flexible. A flexible pusher. All flexible pushers reciprocate in the gap between the bottom of the cartridge and the sliding lid associated at their one end with the first or second pressure bushing of the first or second expandable actuation head, respectively. To be placed under the sliding lid.

  Each of the device cartridges substantially includes a means for forming fastener means disposed within the cartridge near one end thereof, and a free pointed end facing the means for forming. Including at least one basic fastener means-substantially U-shaped staple disposed within the cartridge along its longitudinal axis. U-shaped staples are disposed within the cartridge to extend progressively therefrom and to be formed during this extension.

  Each cartridge has a bottom and a sliding lid and includes at least one standby fastener means—means for storing substantially U-shaped staples. The means for storing includes a slot in the bottom of the cartridge, and at least one spring loaded standby U-shaped staple is disposed in the slot. The waiting staple is disposed in the slot substantially along the longitudinal cartridge axis with the free pointed end facing the means for forming. The standby U-shaped staple substantially extends from the slot so as to extend from the slot by the action of a spring and by partial removal of the flexible pusher from the gap between the cartridge bottom and the sliding lid. Below, it is placed in a slot in the bottom of this cartridge. In the most preferred embodiment, the slot in each cartridge bottom is a through slot and the standby U-shaped staple is spring loaded on the opposite side substantially below the flexible pusher and placed in this slot. Is done.

  Each of the device cartridges has at least one basic fastener means--a recess for placing a substantially U-shaped staple; at least one standby fastener means--to place a substantially standby spring-loaded staple. A through-slot slot, a slot for mounting a sliding lid, and a body with a bottom with a longitudinal duct for positioning at least one flexible pusher. At the same time, the basic U-shaped staple is placed in the bottom recess of the cartridge body in frictional contact with the sliding lid, which prevents the basic U-shaped staple from falling out of this recess, and the standby U-shape. The shaped staple is disposed in the bottom slot of the cartridge body in frictional contact with the flexible pusher, which allows the standby U-shaped staple to extend from the through slot prior to partial removal of the flexible pusher. To prevent.

  The bottom body of each cartridge has a recess for at least one basic fastener means-substantially U-shaped staple. The recess is symmetric about the longitudinal axis of the cartridge and is parallel to its outer surface. The cartridge comprises means for forming a U-shaped staple during its extension from the recess, the means comprising a curved guide connecting the bottom of the recess for the U-shaped staple with the cartridge outer surface. Including the surface. The curved guide surfaces have formed grooves that diverge at an acute angle from each other and from the cartridge longitudinal axis. Basic fastener means--the substantially U-shaped staple has a free pointed end in the body recess of the cartridge such that the pointed end faces a corresponding forming groove on the curved guiding surface Placed in.

  Forming grooves that diverge at an acute angle from each other and from the longitudinal axis of the cartridge during the movement of the body recess and the forming groove of the curved guiding surface of the cartridge during the movement of the corresponding U-shaped staple Providing a curvature that is directed in the opposite direction.

  Each device cartridge is shaped as a substantially polyhedral prism with two inclined sides inclined at an acute angle to each other. This acute apex is located on the longitudinal axis of the expandable working head. All cartridges comprise means for respective connection with the first or fourth bearing bush of the first or second working head or with a corresponding bearing lever. These means include an arm that projects from both bases of the polyhedral prism and is provided with a hole integral with the polyhedral prism.

  All U-shaped staples are made from one of the group of materials including stainless steel, titanium, and shape memory alloys.

  The apparatus comprises means for axial precision positioning including a measurement scale on the tubular body, as well as X applied uniformly on the upper surface of the sign-cartridge and directing the apparatus working head by their operating angle. Means are additionally provided for radial precision positioning including line marks.

  The control mechanism has first and second control modules coupled together through connection means. The first control module is disposed at the free end of the tubular body opposite the first expandable actuation head, and the second control module is rigidly connected to the second expandable actuation head, Located on the tubular body near the first control module between the second expandable head. The connecting means arranged on the tubular body between the first and second control modules can be rigidly secured to each other, or a second control module relative to the first control module and a second rigidly attached thereto. Either reciprocation of the working head can result. The connecting means substantially comprises a holder comprising a gear pivotally mounted therein, a lock and rotary drive, and two toothed racks operatively engaged with the gear, The first is rigidly connected to the first control module and the second is rigidly connected to the second control module. The connecting means additionally comprises a support and a handle for supporting the device and for its placement on the operating table. It also comprises a substantially mechanical or electrical gear rotation drive.

  The first control module of the control mechanism includes a hollow body having first and second ends, and a slider enclosed within the body to be reciprocated relative to the body. The slider includes a holding handle that is rigidly attached thereto and operatively associated with a pivoting head disposed at the second end of the hollow body. This slider together with the swivel head forms the first control means of the first control module of the removal mechanism.

  The first control module of the control mechanism further includes a first pressure handle that serves as second control means. The first pressure handle is pivotally attached to the holding handle and has a short free end that is enclosed within the slider. The slider is rigidly connected to a first axial tube that serves as a first connection means, and the short free end of the pressure handle is functionally associated with a tie that serves as a second connection means for the first control module of the control mechanism. It is done. The first pressure handle includes a swing lock pivotally mounted on the slider, and a flat return spring secured to the pressure handle by one end and to the holding handle by the second end.

  In the proposed device, the first bearing bush of the first expandable operating head is operatively connected to the first control means of the first control module via the first connection means. The first pressure bush is functionally connected to the second control means of the first control module of the control mechanism via the second control means. The second bearing bush is rigidly connected to a distance tube disposed between the first and second working heads. The first connecting means and the second connecting means are enclosed within the distance tube and the tubular body concentrically with each other and the distance tube and the tubular body.

  The second control module of the control mechanism includes a hollow body rigidly attached to or integral with the handle. The main body has a first end and a second end, and is rigidly connected to the fourth bearing bush of the second working head via the holding tube by the first end, and reciprocates with respect to the main body. Also included is a slider that is enclosed within the body for movement. The slider is operatively associated with a swivel head disposed at the second end of the hollow body and together with the swivel head forms a first control means of a second control module of the control mechanism.

  The second control module also has a second pressure handle that serves as its second control means and is pivotally secured to the handle or hollow body. This second pressure handle has a short free end surrounded within the slider, the slider being rigidly connected with a tubular tie serving as a third connecting means, the short free end of the pressure handle being It is functionally associated with a pressure tube that serves as a fourth connecting means and is rigidly connected to the second pressure bushing. The second pressure handle includes a swing lock pivotally mounted within the hollow body, and a flat return spring secured to the second pressure handle by one end thereof and to the hollow body handle by the other end. .

  The third bearing bush is connected to the first control means of the second control module of the control mechanism via the third connection means. The second pressure bush is operatively connected to the second control means of the second control module of the control mechanism via the fourth connection means, and the fourth bearing bush is connected to the second control module of the second control module via the holding pipe. Connected to the main unit. The third connecting means of the second module is surrounded in the holding tube, and the fourth connecting means of the second module is arranged outside the holding tube, they are all arranged concentrically with each other and with the holding tube. Is done.

  First and second connection means connect the first expandable working head with the first control module of the control mechanism. They are arranged concentrically with each other in the third connecting means, the holding tube, and the fourth connecting means, and the third connecting means, the holding tube, and the fourth connecting means are also arranged concentrically with each other, The two working heads are connected to the second control module of the control mechanism. The distance tube is disposed between the first and second working heads outside the first and second connecting means and in alignment with the third and fourth connecting means. The holding tube, the third connecting means, and the fourth connecting means arranged concentrically outside the first and second connecting means form a tubular body configured for positioning within the tube. This tubular body is rigid in the longitudinal direction and flexible in the lateral direction, with the connecting means enclosed therein.

  Another subject matter of the present invention is a method for delivery and fixation of a graft or stent-graft from within a vessel to the vessel wall, comprising several successive steps.

  In the first step, a graft or stent-graft is prepared and attached for delivery and its ends are secured onto the device working head. The graft or stent graft is placed between the working heads and crimped to a given outer diameter.

  In the second stage, the device for delivery and fixation is guided to the operating position and inserted into the corresponding blood vessel, and the first expandable actuation head is guided to the fixation area and the device at a given vessel point. Precision axial and radial positioning is performed via a measurement scale on the surface of the tubular body and via a sign-X-ray mark. The first actuating head is then positioned so that the first end of the delivered graft or stent-graft is in contact with the inner surface of the vessel at the moment of their mutual fixation. A head cartridge is placed near the corresponding stitching point.

  Immediately thereafter, the U-shaped staple in the cartridge of the first expandable actuation head is moved via the first pressure bushing, the second connecting means, and the second control means of the first module of the control mechanism. Achieved by the action of flexible pushers, activated in their order, which are associated with these pushers. As a result, each pointed end of the U-shaped staple enters a groove in the curved guide surface of the corresponding removable cartridge, is curved therein and diverges in opposite directions, prosthetic wall And pierce the surrounding vessel wall and return back to the curved guiding surface on the helix, repeating this rotation if allowed by the given staple length. As a result, the wall at the first end of the prosthesis is stitched to the corresponding region of the vessel wall by a wire helix formed from the U-shaped staple, and the U-shaped staple itself is recessed in the corresponding cartridge. Emerges completely from the cartridge and is released from these cartridges to form an overlock suture at the first end of the corresponding prosthesis.

  Next, the cartridge of the first expandable working head is loaded with standby U-shaped staples. This is achieved by partial removal of the flexible pusher which is activated in that order via the first pressure bushing, the second connecting means and the second control means of the first module of the control mechanism. , They are associated with these pushers. As a result, each of the spring-loaded standby U-shaped staples emerges from the corresponding cartridge through-slot, and then the action of the corresponding flexible pusher is reversed so that the basic U-shaped staple is previously placed. Move into the pit. The first head of the device for delivery and fixation is now ready for another suture.

  Next, if another stitch is needed, the U-shaped staple in the cartridge of the first expandable actuation head is moved. This is achieved by the action of a flexible pusher which is activated in that order via the first pressure bushing, the second connecting means and the second control means of the first module of the control mechanism. Associated with these pushers. As a result, each pointed end of the stand-by U-shaped staple enters the groove formed in the curved guide surface of the corresponding removable cartridge, is curved therein and diverges in opposite directions, prosthesis The wall at the first end and the surrounding vessel wall are pierced and returned back to the curved guiding surface on the helix, repeating this rotation if allowed by the given staple length. As a result, the wall of the prosthesis first end is re-stitched to the corresponding area of the vessel wall by a wire helix formed from the standby U-shaped staple, and the standby U-shaped staple itself is the corresponding cartridge. Emerges completely from the recesses of the cartridge and is released from these cartridges to form a second overlock suture at the end of the first prosthesis.

  Next, if necessary, a prosthesis-thin wall graft that is sutured at one end is deployed. This is achieved by rotation of the connecting means gear, which means that the second control module and the second working head rigidly connected thereto move along the device tubular body a certain distance towards the first control means. Make it possible to do. The prosthesis fixed on the blood vessel by one end and fixed on the second working head by the other end is deployed over its entire length.

  Next, the U-shaped staple in the cartridge of the second working head is moved. This is achieved by the action of a flexible pusher which is activated in that order via the second pressure bushing, the fourth connecting means and the second control means of the second module of the control mechanism. As a result, each pointed end of the U-shaped staple enters a groove in the curved guide surface of the corresponding removable surface, is curved therein and diverges in opposite directions, prosthetic wall And pierce the surrounding vessel wall and return back to the curved guiding surface on the helix, repeating this rotation if allowed by the given staple length. As a result, the prosthesis second end wall is sewn to the corresponding region of the vessel wall by a wire helix formed from the U-shaped staple, and the U-shaped staple itself is recessed in the corresponding cartridge. Appear completely from the cartridge and released from these cartridges to form an overlock suture at the second end of the prosthesis.

  Next, if necessary, the second working head cartridge is loaded with standby U-shaped staples. This is achieved by partial removal of the flexible pusher, which is activated in that order via the second pressure bushing, the fourth connection means and the second control means of the second module of the control mechanism. The As a result, each of the spring-loaded standby U-shaped staples emerges from the corresponding cartridge through-slot, and then the action of the corresponding flexible pusher is reversed so that the basic U-shaped staple is previously placed. Move into the pit. The second head of the device for delivery and fixation is now ready for another suture.

  If another stitch is needed, the standby U-shaped staple in the cartridge of the second working head is moved. This is achieved by the action of a flexible pusher, which is activated in that order via the second pressure bushing, the fourth connection means and the second control means of the second module of the control mechanism. Associated with these pushers. As a result, each pointed end of the U-shaped staple enters the groove formed in the curved guide surface of the corresponding removable cartridge, is curved therein and diverges in opposite directions, the prosthesis The second end wall and the surrounding vessel wall are pierced and returned back to the curved guiding surface on the helix, repeating this rotation if allowed by the given staple length. As a result, the wall of the prosthesis second end is re-stitched to the corresponding region of the vessel wall by a wire helix formed from the standby U-shaped staple, and the U-shaped staple itself is collapsed into the corresponding cartridge. It emerges completely from the recess and is released from these cartridges to form a second overlock suture at the prosthesis second end.

  The second end of the graft to be delivered and sutured is then separated from the device for delivery and fixation, both expandable heads being returned to their original position, the device being in the non-operating position. And removed from the graft as well as from the blood vessel.

  The present invention will now be described in conjunction with the following drawings, in which like reference numbers refer to like elements.

  Preferred embodiments of the invention are described below. The inventor of the present subject matter anticipates that the embodiments described herein may be used in other vascular repairs as well as in other procedures. Thus, it is intended that the present invention cover modifications and variations of this invention provided they are within the scope of the appended claims and their equivalents.

  The most preferred embodiment of the device according to the invention is shown in FIGS.

  The proposed device 1 (FIG. 1) comprises a tubular body 3, two expandable actuation heads 5 and 7 comprising a cartridge 9 intended for the placement of fastener means, substantially U-shaped staples, and a blood vessel. And means for securing the ends of the implant 13 to these heads (FIG. 2). The apparatus 1 includes a control mechanism 15 including a first control module 17, a second control module 19, and connection means 21 for joining them together using a support handle 23 and a support body 25.

  The tubular body 3 of the device 1 (FIG. 1) is configured to be positioned within a blood vessel. The tubular body 3 is rigid in the longitudinal direction and flexible in the lateral direction, and the expandable actuating heads 5 and 7 are arranged at one end (FIGS. 1 and 2) and are controlled at the second end. A mechanism 15 is arranged.

  Actuating heads 5 and 7 are arranged at the free ends of the tubular body 3 (FIGS. 1 and 2) and connect the ends of the supply graft or stent graft 13 in contact with the inner surface of the blood vessel at the moment of their mutual fixation. It is expandable to maintain. Each of the working heads 5 and 7 comprises a group of cartridges each containing substantially eight cartridges, which are incorporated during the construction of the corresponding working head 5 or 7. All the cartridges 9 are integrated and replaceable, each of which is intended for placement of at least two fastener means-U-shaped staples 11. All cartridges 9 store and deliver standby fastener means, as well as to form fastener means-U-shaped staples 11 during their expansion from the cartridge, as well as to convey progressive motion to them. For this purpose, means are provided for retaining the fastener means therein.

  The first expandable actuating head 5 (FIG. 3) comprises a first pressure bush 27 and a first bearing bush 29 and a second bearing bush which are arranged one after the other starting from the free end of this working head 5. 31 and a first axial pipe 33 that is rigidly connected to the first bearing bush 29 and communicates through a through-shaft hole in the second bearing bush 31. The second bearing bush 31 is shown in more detail in FIG.

  The first expandable actuation head 5 (FIG. 3) comprises eight cartridges, which are pivotally mounted by their one end on the first bearing bush 29 and on the second bearing bush 31. They are pivotally connected by their other ends with bearing levers 35 that are pivotally mounted.

  A second expandable working head 7 (FIG. 3), which is arranged at a distance from the first working head 5, continues from the free end of this working head 7 facing the first expandable working head 5. Each of the third bearing bush 37 and the fourth bearing bush 39, and the second pressure bush 41, are arranged. The second head 7 also has a second axial tube 43 which is rigidly connected to the third bearing bush 37 and communicates through a through shaft hole in the fourth bearing bush 39 and in the second pressure bush 41. The third and fourth bearing bushings 37, 39 and the second pressure bushing 41 are aligned with the tubular body 3. The second actuating head 7 (FIG. 3) also comprises eight cartridges 9, which are mounted by their one end on the fourth bearing bush 39 and pivoted on the third bearing bush 37. Are pivotally connected by their other ends using bearing levers 35 attached to the.

  Both actuating heads 5 and 7 also comprise means for securing the endovascular graft or stent graft 13 thereon, the endovascular graft or stent graft being disposed on the bearing lever 35, and In the vicinity of their pivot connection with the corresponding cartridge 9, they are substantially shaped as radial tongues 45 arranged at one of the ends of these bearing levers 35 (FIG. 3).

  The control mechanism 15 of the apparatus 1 includes a first control module 17 and a second control module 19 that are coupled together via a connection means 21. A control mechanism 15 (FIGS. 1 and 2) is located at the end of the tubular body 3 on the opposite side of the actuating heads 5 and 7 and is thus associated with these actuating heads 5 and 7. The first control module 17 is arranged at the free end of the tubular body 3, and the second control module 19 is on the tubular body 3 in the vicinity of the first module 17 between the first module and the second expandable operating head 7. Is arranged. The first control module 17 serves to operate the first working head 5, and the second control module 19 serves to operate the second working head 7. The control modules 17 and 19 are joined together on the tubular body 3 via connecting means 21 arranged between them. It provides both a rigid fixation of the modules 17 and 19 with respect to each other and a reciprocating movement of the second working head 7 which is rigidly attached to the second module 19 and the second module with respect to the first control module 17 ( 1 and 2).

  Each cartridge 9 (FIG. 5) includes at least one basic fastener means—means for holding a U-shaped staple 11 therein. This holding means comprises a sliding lid 47 arranged along the cartridge 9 and provided with a hole 49 for its opening.

  Each cartridge 9 (FIGS. 3, 5) of the device 1 includes at least one means for imparting a progressive movement to the fastener means-U-shaped staple 11, which means is longitudinally rigid and A flexible pusher 51 that is flexible in the lateral direction is included. All the flexible pushers 51 are associated with the first or second pressure bushing 27 or 41 of the first or second expandable actuation head 5 or 7 respectively by one end and the sliding lid 47 of the cartridge 9. And reciprocates in the gap between the bottom of the cartridge 9 and the sliding lid 47.

  Each cartridge 9 of the device 1 (FIG. 5) has means for forming fastener means disposed within the cartridge 9 near one end thereof, as well as within the cartridge 9 substantially along its longitudinal axis. Including at least one basic fastener means-U-shaped staple 11 with the free pointed end facing this forming means. The U-shaped staple 11 is disposed within the cartridge 9 so as to extend progressively therefrom and to be formed during this extension.

  All cartridges 9 (FIGS. 5 and 6) include a means for storing at least one standby fastener means having a bottom 53 and a sliding lid 47 and including a standby U-shaped staple 11. This storage means includes a slot 55 in the bottom 53 of the cartridge 9 (FIG. 6), in which at least one spring-loaded standby U-shaped staple 11 is arranged. The standby staple 11 is disposed in the slot 55 substantially along the longitudinal axis of the cartridge, with the free pointed end 57 facing the forming means. The standby U-shaped staple 11 is substantially extended from this slot 55 by the action of the spring 59 and by partial removal of the flexible pusher 51 from the gap between the bottom 53 of the cartridge 9 and its sliding lid 47. Under the flexible pusher 51, it is disposed in a slot 55 in the bottom 53 of the cartridge (FIG. 9). In the most preferred embodiment (FIGS. 6-10), the slot 55 in the bottom 53 of each cartridge 9 is a through slot and the standby U-shaped staple 11 is directly below the flexible pusher 51 and on the opposite side. It is loaded by a spring 59 and disposed in this slot 55.

  Each cartridge 9 (FIGS. 5-10) of the device 1 has a standby fastener means such as a recess 61 for placement of at least one U-shaped staple 11 and at least another spring-loaded U-shaped staple 11. It has a body with a bottom 53 with a through slot 55 for placement, a slot 63 for mounting a sliding lid 47 and a longitudinal duct 65 for placement of at least one flexible pusher 51. The basic U-shaped staple 11 is disposed in a recess in the bottom 53 of the cartridge 9 in frictional contact with the sliding lid 47, which prevents the basic U-shaped staple from falling out of this recess 61. The standby spring-loaded U-shaped staple 11 is disposed in the through slot 55 of the bottom 53 of the cartridge 9 in frictional contact with the flexible pusher 51, and is disposed before the partial removal of the flexible pusher 51. The standby spring-loaded U-shaped staple is prevented from extending from the through slot 55.

  The bottom 53 of each cartridge 9 (FIGS. 5-10) has a recess 61 for basic fastener means-U-shaped staple 11. This recess 61 is symmetrical about the longitudinal axis of the cartridge 9 and is parallel to its outer surface 67 (FIGS. 5 to 7). The cartridge 9 comprises means for forming a U-shaped staple 11 during its extension from the recess 61, which means the bottom of the recess 61 for the U-shaped staple 11 on the cartridge 9. It includes a curved guiding surface 69 that connects to the outer surface 67. The curved guiding surfaces 69 have forming grooves 71 that diverge at an acute angle from each other and from the longitudinal axis of the cartridge 9 (FIGS. 5 to 7 and 10). The basic fastener means-U-shaped staple 11 has a pointed free end 57 that is recessed in this cartridge 9 so that the pointed end 57 faces the corresponding forming groove 71 of the curved guiding surface 69. 61.

  Forming grooves 71 that diverge at an acute angle from each other and from the longitudinal axis of the cartridge 9 (FIGS. 5 to 10) correspond to the corresponding U during the operation of the recess 61 and the forming groove 71 of the curved guiding surface 69 of the cartridge 9. The pointed end 57 of the U-shaped staple 11 is provided with a spirally directed curvature.

  All cartridges 9 of the device 1 are substantially shaped as polyhedral prisms with two inclined side surfaces 73, 75 inclined at an acute angle with respect to each other (FIGS. 5 to 10). This acute apex is located on the longitudinal axis of the expandable working head 5 or 7. All the cartridges 9 are provided with means for connecting to the first bearing bush 29 or the second bearing bush 39 of the first working head 5 or the second working head 7 or the corresponding bearing lever 35 respectively. These means include an arm 77 with a hole 79 (FIG. 8), which projects from both bases of the polyhedral prism and is integral with the polyhedral prism.

  All U-shaped staples 11 are made from one of the group of materials including stainless steel, titanium, and shape memory alloys.

  The apparatus 1 is applied evenly on the outer surface of the axial precision positioning means including the measurement scale on the surface of the tubular body 3 and the markers-cartridge 9 and the working heads 5 and 7 of the apparatus 1 are applied to them. Are additionally provided with radial precision positioning means including X-ray contrast marks which serve to direct only the operating angle (not shown in the drawing).

  The control mechanism 15 includes a first control module 17 and a second control module 19 that are integrally joined via the connection means 21. The connecting means 21 (FIG. 11) is arranged on the tubular body 3 between the first control module 17 and the second control module 19 and is rigidly fastened to them or a second relative to the first control module 17. Both the control module 19 and the reciprocating movement of the second working head 7 rigidly attached thereto are provided. The connecting means 21 (FIG. 11) includes a holder 81 having a gear 83 pivotally mounted therein and having a lock 85, a mechanical or electrical rotary drive device connected to a shaft 87, and a gear 83. It includes two toothed racks 89 and 91 that are functionally engaged, the first one being rigidly connected to the first control module 17 and the second one being a second control module 19. And rigidly connected. The connecting means comprises a support 25 and a handle 23 for supporting the device 1 and for its placement on the operating table.

  The first control module 17 of the control mechanism 15 includes a hollow body (FIG. 11) having a first end 95 and a second end 97 and a slider 99 surrounded within the body 93 to reciprocate relative to the body. The slider 99 comprises a holding handle 101 rigidly attached thereto and operatively associated with a swivel head 103 disposed at the second end 97 of this hollow body 93. This slider 99 forms the first control means of the first control module 17 of the control mechanism 15 together with the turning head 103.

  The first control module 17 of the control mechanism 15 further includes a first pressure handle 105 that serves as second control means. The first pressure handle 105 is pivotally attached to the holding handle 101 and has a short free end 107 that is enclosed within a slider 99. The slider 99 is rigidly connected to a first axial tube 33 (FIG. 3) that serves as a first connecting means, and the short free end 107 of the pressure handle 105 is the second of the first control module 17 of the control mechanism 15. It is functionally associated with a tie 109 (FIGS. 3 and 11) that acts as a connecting means. The first pressure handle 105 is a swing lock 111 pivotally mounted on the slider 99, and a flat return spring fixed to the pressure handle 105 by one end thereof and fixed to the holding handle 101 by the second end thereof. 113.

  In the proposed device 1, the first bearing bush 29 of the first expandable working head 5 is functionally connected to the first control means of the first control module 17 via the first connection means-first axial tube 33. (FIGS. 3 and 11). The first pressure bush 27 is functionally connected to the second control means of the first control module 17 of the control mechanism 15 via the second connection means-body 109. The second bearing bush 31 is rigidly connected to a distance pipe 115 disposed between the first working head 5 and the second working head 7. The first connecting means and the second connecting means are concentrically surrounded by the distance tube 115 and the tubular body 3, the distance tube 115 and the tubular body 3.

  The second control module 19 (FIGS. 3 and 11) of the control mechanism 15 includes a hollow body 117 having a handle 119 attached thereto rigidly or integrally therewith. The main body 117 has a first end 121 and a second end 123, and is rigidly connected to the second working head 7 by the first end via a holding tube 125 (FIG. 3). A slider 127 surrounded by the main body 117 so as to reciprocate with respect to the main body 117. The slider 127 is operatively associated with a swivel head 129 mounted on the second end 123 of the hollow body 117, and together with the swivel head 129 forms the first control means of the second control module 19 of the control mechanism 15. To do.

  The second control module further comprises a second pressure handle 131 that serves as its second control means and is pivotally attached to the handle 119 or the hollow body 117. The second pressure handle 131 has a short free end 133 that is surrounded within the slider 127. The slider 127 is rigidly connected to a tubular tie 135 (FIG. 3) that serves as third connection means, and the short free end 133 of the pressure handle 131 serves as the fourth connection means of the control mechanism 15 and the second pressure bushing. 41 is functionally associated with a pressure tube 137 that is rigidly connected to 41. The second pressure handle 131 is pivotally mounted in the hollow body 117 and is pivotally attached to the second pressure handle 131 by one end thereof, and the handle 119 of the main body 117 by its second end. A flat return spring 141 is provided.

  The third bearing bush 37 is connected to the first control means of the second control module 19 of the control mechanism 15 via the third connection means-tubular tie 135. The second pressure bush 41 is functionally connected to the second control means of the second control module 19 of the control mechanism 15 via the fourth connection means-pressure pipe 137. The fourth bearing bush 39 is connected to the main body of the second control module 19 via the holding tube 143. The third connecting means-tubular tie 135 of the second module 19 is enclosed in a holding tube 143, and the fourth connecting means-pressure tube 137 is arranged outside this holding tube 143, they are all connected to each other as well as to each other. It is arranged concentrically with the holding tube 143.

  The first connecting means and the second connecting means—the first axial tube 33 and the tie 109 connect the first expandable working head 5 with the first control module 17 of the control mechanism 15. They are arranged concentrically with each other and are enclosed within a third connecting means—tubular tie 135, a holding tube 143, and a fourth connecting means—pressure tube 137, which are arranged concentrically with each other to provide a second working head. 7 is connected to the second control module 19 of the control mechanism 15. The distance tube 115 is arranged between the first working head 5 and the second working head 7 outside the first connecting means and the second connecting means, in alignment with the third connecting means and the fourth connecting means. Yes. The fourth connecting means-pressure pipe 137 is concentric with the holding pipe 143, the third connecting means-tubular tie 135, and the first connecting means and the second connecting means-the first axial pipe 33 and the tie 109, Forming a tubular body 3 arranged on the outside and configured for positioning in the tube. This tubular body 3 is rigid in the longitudinal direction and flexible in the lateral direction, with the connecting means enclosed therein.

  The proposed device 1 delivers a prosthesis-graft or stent graft 13 into a blood vessel, substantially inside the aorta 200, and from within the aorta, the prosthesis-graft or stent graft. It operates based on the proposed method for securing 13 to the wall of the aorta 200 (FIG. 12). The proposed method involves several successive steps. In a first step, the graft or stent graft 13 is prepared and attached for delivery, and its ends are fixed on the working heads 5 and 7 of the device 1 so that the graft or stent graft 13 is Located between the working heads 5 and 7 and crimped to a given outer diameter.

  In the second step, the device 1 for delivery and fixation is set in the operating position and inserted into the corresponding blood vessel, specifically the aorta 200, and the first expandable actuation head 5 is guided to the fixation area. The precise axial and radial positioning of the device 1 is carried out at a given point of the blood vessel, the aorta 200, via the measurement scale on the surface of the tubular body 3 and via the marker-X-ray contrast mark (see FIG. 12). The first actuation head 5 then causes the first end of the prosthesis-graft or stent-graft 13 to be in contact with the inner surface of the blood vessel-aorta 200 at the moment of their mutual fixation. Arranged, the cartridge 9 of this expandable working head 5 is arranged near the corresponding stitching point.

  Next, the U-shaped staple 11 in the cartridge 9 of the first expandable actuation head 5 is moved, which is the first pressure bush 27, the second connection means-tie 109, and the second control means-control module 15. This is achieved by the action of the flexible pushers 51, which are activated in their order via the pressure handles 105 of the first module 17, and are associated with these pushers. As a result, the pointed end 57 of each U-shaped staple 11 enters the forming groove 71 of the curved guide surface 69 of the corresponding removable cartridge 9 and is curved therein to diverge in opposite directions. Perforate the wall of the prosthesis-graft or stent-graft 13 and the peripheral wall of the aorta 200 and return back to the curved guide surface 69 on the helix, if allowed by the given length of staple 11 Repeat this rotation. As a result, the wall at the first end of the prosthesis-graft or stent-graft 13 is sutured to the corresponding wall region of the aorta 200 by the wire helix formed by the U-shaped staple 11 to form a U-shape. The staples 11 themselves emerge completely from the recesses 61 of the corresponding cartridges 9 and are released from these cartridges 9 to form an overlock suture at the first end of the prosthesis-graft or stent-graft 13 (FIG. 12).

  Next, the cartridge 9 of the first expandable working head 5 is re-loaded with the standby U-shaped staple 11. This is activated in that order via the pressure handle 105 of the first module 17 of the first pressure bush 27, second connection means-tie 109 and second control means-control mechanism 15. Achieved by partial removal of the flexure pushers 51, which are associated with these pushers. As a result, each spring-loaded standby U-shaped staple 11 emerges from the through slot 55 of the corresponding cartridge 9, and then, by the reverse operation of the corresponding flexible pusher 51, the action causes the basic U-shaped staple 11. Moves into the recess 61 previously placed. The first head 5 of the device 1 for feeding and fixing is now ready for another stitching.

  Next, if another stitch is needed, the standby U-shaped staple 11 in the cartridge 9 of the first expandable actuation head 5 is moved. This is activated in that order via the pressure handle 105 of the first module 17 of the first pressure bush 27, second connection means-tie 109 and second control means-control mechanism 15. This is achieved by the action of the flexible pusher 51. As a result, the pointed end 57 of each standby U-shaped staple 11 enters the forming groove 71 of the curved guide surface 69 of the corresponding removable cartridge 9 and is curved therein and diverges in opposite directions. Then, the wall of the first end of the prosthesis-graft or stent-graft 13 and the peripheral wall of the aorta 200 are pierced back to the curved guiding surface 69 on the helix, depending on the required length of the staple 11 Repeat this rotation if allowed. As a result, the wall at the first end of the prosthesis-graft or stent-graft 13 is re-stitched to the peripheral wall of the aorta 200 by the wire helix formed from the standby U-shaped staple 11 and is U-shaped. The staples 11 themselves emerge completely from the recesses 61 of the corresponding cartridges 9 and are released from these cartridges 9 to form a second overlock suture at the first end of the prosthesis-graft or stent-graft 13. (FIG. 12).

  Next, the prosthesis that is sutured at one end-if it is a thin-walled implant 13, deploys when it is needed. This is achieved by the rotation of the gear 83 of the connecting means 21, which causes the second control module 19 and the second working head 7 rigidly connected thereto to be at a certain distance towards the first control module 17, of the device 1. It is possible to move along the tubular body 3. The graft 13 fixed on the blood vessel-aorta 200 by one end and fixed on the second working head 7 by the other end is deployed over its entire length (FIGS. 11 and 12).

  Next, the U-shaped staple 11 in the cartridge 9 of the second working head 7 is moved. This is activated in that order via the second pressure bush 41, the fourth connecting means-pressure tube 137, and the pressure handle 131 of the second module 19 of the second control means-control mechanism 15. This is achieved by the action of the flexible pusher 51. Thereby, the pointed end 57 of each U-shaped staple 11 enters the forming groove 71 of the curved guide surface 69 of the corresponding removable cartridge 9 and is curved therein and diverges in opposite directions, If the prosthesis-graft or stent-graft 13 wall and the peripheral wall of the aorta 200 are perforated, return to the curved guide surface 69 over the helix and this rotation if allowed by the required length of the staple 11 Repeat. As a result, the wall at the second end of the prosthesis-graft or stent-graft 13 is sutured to the peripheral wall of the aorta 200 by a wire helix formed from the U-shaped staple 11, and the U-shaped staple 11. As such, they emerge completely from the corresponding cartridge recesses 61 and are released from these cartridges 9 to form an overlock suture at the second end of the prosthesis-graft or stent-graft 13 (FIG. 12).

  Next, if necessary, the cartridge 9 of the second working head 7 is re-loaded with the standby U-shaped staple 11. This is activated in that order via the second pressure bush 41, the fourth connecting means-pressure tube 137, and the pressure handle 131 of the second module 19 of the second control means-control mechanism 15. This is accomplished by partial removal of the flexible pushers 51 and they are associated with these pushers. As a result, each spring-loaded U-shaped staple 11 emerges from the through slot 55 of the corresponding cartridge 9, and then, by the reverse operation of the corresponding flexible pusher 51, the action causes the basic U-shaped staple 11 to move. It moves into the recess 61 that was previously arranged. The second head of the device 1 for feeding and securing is now ready for another stitching.

  If another stitch is required, the standby U-shaped staple 11 in the cartridge 9 of the second working head 7 is moved. This is activated in that order via the second pressure bush 41, the fourth connecting means-pressure tube 137, and the pressure handle 131 of the second module 19 of the second control means-control mechanism 15. Achieved by the action of the flexible pushers 51, they are associated with these pushers. As a result, the pointed end 57 of each standby U-shaped staple 11 enters the forming groove 71 of the curved guide surface 69 of the corresponding removable cartridge 9 and is curved therein and diverges in opposite directions. Then, the second end wall of the prosthesis-graft or stent-graft 13 and the peripheral wall of the aorta 200 are pierced (FIG. 12) and returned to the curved guide surface 69 over the helix and the staple 11 This rotation is repeated if allowed by the given length. Thereby, the wall of the second end of the prosthesis-graft or stent-graft 13 is re-stitched to the corresponding wall region of the aorta 200 by the wire helix formed from the standby U-shaped staple 11, and the standby U The shaped staples 11 themselves emerge completely from the recesses in the corresponding cartridges 9 and are released from these cartridges 9 to form a second overlock stitch at the second end of the prosthesis-graft or stent graft 13. (FIG. 12).

  The delivered and sutured prosthesis-graft or stent graft 13 second end is then separated from the device 1 for delivery and fixation, both expandable actuation heads 5 and 7 being Returning to the initial position, the device 1 is set to a non-operating position and removed from the prosthesis-graft or stent-graft 13 as well as from the blood vessel-aorta 200.

  Use of the proposed device 1 and this device in a new and improved method for the delivery and fixation of a prosthesis-graft or stent-graft 13 from within the vessel-aorta 200 to the vessel-aortic wall The implementation based on can, in the author's view, solve the problem of endoscopic delivery and endoscopic suturing of the graft or stent graft 13 to the aorta 200 without performing cavity surgery To. At the same time, it may occur due to peristaltic reciprocation of the wall of the aorta 200 and vibrations of the patient's body during its movement, so that the sutured or stent-graft 13 moves from the desired position within the vessel-aorta 200 Solve the problem of preventing.

  While this invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, the preferred embodiments of the invention as set forth herein are intended to be illustrative rather than limiting. Various changes may be made without departing from the spirit and scope of the invention as defined in the following claims.

It is a general view which shows the apparatus proposed. FIG. 6 is a side view of the proposed device during graft suturing. FIG. 3 is an overall view showing a first working head and a second working head of an apparatus comprising a graft that is fixed at the moment of suturing a first graft end (where a first working head is disposed); It is a general view which shows a 2nd bearing bush. It is a general view which shows the cartridge combined with the sliding lid. It is a general view which shows the cartridge provided with the arm for the fixation, and the through-hole in a bottom part. FIG. 5 is a partial view of the cartridge as seen from the means for forming staples. FIG. 5 is an overall view showing the cartridge as seen from its bottom and through slot. FIG. 2 is an overall view showing a cartridge with an illustration of the location of basic U-shaped staples and standby U-shaped staples. FIG. 2 is an overall view showing a cartridge with an illustration of the location of basic U-shaped staples and standby U-shaped staples. It is a side view which shows an apparatus control mechanism. It is an operation | movement figure which shows the apparatus proposed.

Claims (20)

A device for the supply and fixation of endovascular grafts or stent grafts,
a) including a tubular body configured for inward positioning of the blood vessel, the tubular body being longitudinally rigid and laterally flexible, with two working heads at one end thereof Arranged, and at the other end, a control mechanism is arranged,
b) a first actuating head intended for the arrangement of the fastener means, which is rigidly fixed to the free end of the tubular body and at the moment of their mutual fixation Expandable to maintain the free end in contact with the inner surface of the blood vessel,
c) includes a second working head intended for the arrangement of the fastener means, which is aligned with the first working head at a distance from the first working head and is free of the tubular body Fixed near the limb, this working head is also expandable, and at the moment of their mutual fixation, serves to keep the second end of the supplied graft in contact with the inner surface of the blood vessel,
d) including two cartridge groups, each group containing eight cartridges, each cartridge being incorporated within the structure of the first and second working heads, all cartridges being integrated and replaceable Each of the cartridges is intended for the arrangement of at least two fastener means, and all the cartridges are fastened during their extension from these cartridges to impart a progressive action thereto. Means for holding the fastener means therein, as well as for storing and feeding the standby fastener means,
e) a first control module for operation of the first working head, disposed at a free end of the tubular body opposite the first working head, and rigidly connected to the second working head; Control means comprising a second control module disposed on the tubular body between the first control module and a second actuating head, serving for its operation, the first and second controls The modules are joined together via connecting means,
Thereby, surgery can be performed for graft or stent-graft delivery as well as for fixing both ends of the vessel from inside the aorta to the vessel wall, substantially to the wall of the aorta,
apparatus.   The first expandable working head comprises a first pressure bush and first and second bearings arranged in succession one after the other starting from the free end of the working head and in alignment with the tubular body. The apparatus of claim 1, comprising a bush and a first axial tube rigidly connected to the first bearing bush and passing through a through axial hole in the second bearing bush. The first expandable actuating head is pivotally mounted with a bearing lever pivotally mounted on the first bearing bush by one end thereof and pivotally mounted on the second bearing bush by their other end. The apparatus of claim 2 comprising at least eight cartridges attached to the cartridge. 4. The apparatus of claim 3 , wherein the first and second actuation heads comprise means for securing a supplied implant disposed on a bearing lever. The means for securing the supplied implant is substantially shaped as a radial tongue located at one of the ends of the corresponding bearing lever, in the vicinity of their pivot connection with the corresponding cartridge. 5. The apparatus of claim 4 , wherein:   Each of the cartridges includes at least one basic fastener means therein, means for holding a substantially U-shaped staple, and the means for holding is disposed along the cartridge. The apparatus of claim 1, substantially comprising a sliding lid. Each of the cartridges also includes at least one means for imparting a progressive motion to the fastener means, a substantially U-shaped staple, the means being longitudinally rigid and laterally possible. The apparatus of claim 6 , comprising a flexible flexible pusher. Each of the cartridges is disposed within the cartridge near one of its ends, the means for forming fastener means, and the free pointed end facing the means for forming And including at least one basic fastener means, substantially U-shaped staple, disposed in the cartridge substantially along its longitudinal axis, the U-shaped staple being progressively advanced therefrom. 7. The apparatus of claim 6 , wherein the apparatus is disposed within the cartridge to be extendable and formable during the extension.   Each of the cartridges includes at least one basic fastener means and at least one standby fastener means, substantially U-shaped staples, the staples including stainless steel, titanium, and a shape memory alloy. The apparatus of claim 1, comprising one of a group of materials.   The apparatus of claim 1, further comprising means for axial precision positioning including a measurement scale on the surface of the tubular body.   Indicia-additionally comprising means for radial precision positioning including X-ray marks regularly applied on the outer surface of the cartridge and serving to direct the device working head by their operating angle; The apparatus of claim 1.   The control mechanism comprises at least one first control module and at least one second control module coupled together by connecting means, the first control module being opposite the first expandable actuation head. Disposed at the free end of the tubular body at a side, wherein the second control module is rigidly connected to the second expandable actuation head, between the first control module and the second expandable actuation head. The apparatus of claim 1, disposed on the tubular body near the first control module. The connecting means disposed on the tubular body between the first and second control modules is reciprocable along the axis of the tubular body, for supporting the device and on an operating table The apparatus of claim 12 , further comprising a support and a handle for its placement. 13. Apparatus according to claim 12 , wherein the connecting means disposed on the tubular body between the first and second control modules comprises a substantially mechanical or electrical gear rotation drive. The second control module of the control mechanism includes a hollow body with a handle rigidly attached thereto, the body having first and second ends, by which the holding tube is held by the first end. Including a slider rigidly connected to the fourth bearing bush of the second working head via the second body and reciprocally enclosed within the body, the slider being disposed at the second end of the hollow body 13. The apparatus of claim 12 , wherein the apparatus is functionally associated with the swivel head to form the first control means of the second control module of the control mechanism with the swivel head. The second control module also has a second pressure handle that serves as its second control means and is pivotally attached to the handle or to the hollow body, the second pressure handle being short enclosed within the slider. A pressure tube having a free end, wherein the slider is rigidly connected to a tubular tie serving as third connection means, and the short free end of the pressure handle serves as the fourth connection means of the control mechanism The apparatus of claim 15 , wherein the apparatus is functionally associated with and rigidly connected to the second pressure bushing. The second pressure handle is pivotally mounted within the hollow body, and is fixed to the second pressure handle by one end and fixed to the hollow body handle by the second end. The apparatus of claim 16 , comprising a flat return spring. The third bearing bush is connected to the first control means of the second control module of the control mechanism via third connection means, and the second pressure bush is connected to the control mechanism via fourth connection means. The fourth control bush is functionally connected to the second control means of the second control module, and the fourth bearing bush is connected to the main body of the second control module via a holding tube, and the third connection means of the second module is surrounded by the holding pipe, said fourth connection means of the second module is positioned on the outside of the holding tube, which are disposed all together and the holding tube and the concentric claim 16 Equipment. The first and second connecting means for connecting the first operating head with the first control module of the control mechanism are arranged concentrically with each other in the third connecting means, the holding tube, and the fourth connecting means. They are also arranged concentrically with each other, connect the second working head with the second control module of the control mechanism, and the distance tube is connected to the first and second outside the first and second connecting means. 19. Apparatus according to claim 18 , arranged between said actuating heads and aligned with said third and fourth connecting means. The holding tube, the third connecting means, and the fourth connecting means arranged concentrically outside the first and second connecting means form a tubular body configured for positioning in the pipe; 20. A device according to claim 19 , wherein the tubular body is rigid in the longitudinal direction and flexible in the lateral direction with connecting means enclosed therein.

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