Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
  • A61B17/0483—Hand-held instruments for holding sutures
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
  • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
  • A61B17/062—Needle manipulators
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
  • A61B2017/00238—Type of minimally invasive operation
  • A61B2017/00243—Type of minimally invasive operation cardiac
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
  • A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
  • A61B2017/00336—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means with a protective sleeve, e.g. retractable or slidable
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
  • A61B17/0469—Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
  • A61B2017/047—Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery having at least one proximally pointing needle located at the distal end of the instrument, e.g. for suturing trocar puncture wounds starting from inside the body
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
  • A61B17/0469—Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
  • A61B2017/0472—Multiple-needled, e.g. double-needled, instruments
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
  • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
  • A61B2017/06057—Double-armed sutures, i.e. sutures having a needle attached to each end

Definitions

• the invention relates to the technical field of cardiac surgery, and more particularly relates to a device for suturing a cardiac valve prosthesis, for example for the repair or replacement of an aortic valve or a mitral valve. a heart.
• valvular implant In the field of cardiac surgery, it is known to perform interventions to replace an aortic or mitral valve, open heart, that is to say in extracorporeal circulation.
• the valvular implant is attached via a plurality of sutures placed after ablating the calcified valve. To do this, it is necessary to make, using needles and suture son, a bundle of son, up to 40 son, allowing the establishment and fixation of the prosthetic valve on the native ring of the valve. In practice, these wires are placed one by one, and are spaced evenly around the circumference of the native ring.
• the aim of the invention is to remedy the drawbacks of the state of the art, by proposing a device for suturing a cardiac valve prosthesis, which enables a surgeon to be able to manipulate the wires of the patient. suture, without risk of mixing, losing, or tangling.
• Another object of the invention and therefore to provide such a device that can significantly shorten the time associated with the surgical operation.
• a device for suturing a cardiac valve prosthesis remarkable in that it comprises an assembly adapted to cooperate with a handle subject to control means for actuating the assembly for suturing the prosthesis on a heart valve.
• the assembly is arranged at the free end of a handling rod and comprises:
• the needle assembly is held in a cylindrical configuration between, on the one hand, a plurality of guides through which the pairs of needles slide freely and, on the other hand, a plurality of push elements supporting the pairs of needles; on the side of the free end of the rod, the guides and the pushing elements are movable along the rod and are pivotally connected to the rod so as to pass, under the action of the control means, a folded position along the rod at an extended position spaced from the rod to increase the diameter of the cylindrical configuration of the needle assembly;
• the device according to the invention allows a surgeon to position the free end of the manipulation rod through the cardiac valve to be repaired, and to position the set of needles in the cylindrical configuration. support under the native ring.
• one of the clamping rings When the needles are in support under the native ring, one of the clamping rings is positioned against the support of the other side of the native ring to allow the pushing elements to push the needles until those through the native ring and fit into the clamping ring.
• the locking means of the ring make it possible to maintain the set of needles in a cylindrical configuration so as to allow the pushing elements, the guides, and more generally the manipulation rod to be removed from the core. In this configuration, the surgeon can withdraw from the heart and simultaneously all the needles held by the clamping ring to form a bundle of sutures attached, on the one hand, to the native ring of the valve and, other hand connected to different needles.
• This wire bundle is under control, the risks of losing, mixing or entangling the sutures are removed.
• the surgeon can then position the prosthetic valve, for example textile ring, directly on the clamping ring, being pierced by all the needles, and blocked against support by the second clamping ring which is inserted around the needles against support.
• the surgeon can remove the lower clamping ring, that is, the one positioned on the side of the heart valve, allowing it to slide the prosthetic valve to the native ring of the heart valve and in support against the latter.
• the surgeon only has to remove the needles two by two and tie the sutures to permanently fix the prosthetic valve. The operation is simple and fast.
• each guide is in the form of a sleeve comprising an eight-shaped cross-section, and in particular for optimally guiding a pair of needles, while allowing the passage of the son. suture when the guide is removed.
• each pusher element is, for example, in the form of a sheath comprising a cross section in the form of eight, including a bottom wall to be able to push the pair of needles towards the valve, said bottom wall also having an opening for passage of the suture when the pusher member is removed.
• each clamping ring comprises:
• the rotation of the inner ring allows the portion walls of said inner ring to at least partially close off the orifices; , and to be housed in complementary notches in the needles for locking the ring and maintaining the cylindrical configuration of the set of needles.
• the inner ring comprises a crenelated inner periphery for cooperating with means for driving it in rotation.
• the guides and the pusher elements are each connected to the handling rod by at least one articulated arm relative to the rod.
• the arms of the guides and push elements are pivotally connected to the rod so as to pass, under the action of the control means, simultaneously or selectively, and independently of each other from the folded position to the deployed position. .
• the device advantageously comprises a protective cover slidably mounted around the handling rod to cap the pointed end of the set of needles.
• FIG. 1 illustrates in perspective, the device according to the invention, with the protective cover removed and a clamping ring;
• FIG. 2 illustrates the clamping ring in perspective, the inner ring is not in the locking position;
• FIG. 3 is similar to Figure 2, with the inner ring in the locking position;
• FIG. 4 illustrates the device according to the invention in longitudinal section, after insertion through the heart valve
• FIG. 5 is similar to FIG. 4, the protective cover being removed, and the guides and pushing elements being moved in the direction of the cardiac valve;
• FIG. 6 is similar to FIG. 5, the arms of the guides and of the pushing elements being pivoted to move away from the rod in order to be able to position the needles in support under the native ring of the cardiac valve;
• Figure 7 is similar to Figure 6, one of the clamping rings having been positioned against the other side of the native ring of the heart valve;
• Figure 8 is similar to Figure 7, the pusher elements having been moved towards the guides so that the needles pass through the native ring of the mitral valve and the clamping ring;
• Figure 9 is similar to Figure 8, the inner ring of the clamping ring having been rotated to lock the needle assembly in its cylindrical configuration;
• FIG. 10 is similar to Figure 9, the pusher elements are moved to move away from the guides for their removal;
• FIG. 11 is similar to Figure 10, the guides being moved towards the pusher elements for their removal;
• FIG. 12 is similar to FIG. 11, the handling rod having been removed to leave only the set of needles held in a cylindrical configuration by the clamping ring;
• FIG. 13 is similar to Figure 12, the needle assembly being removed to form a bundle of sutures attached to the native ring of the heart valve;
• FIG. 14 is similar to FIG. 13, before the anchoring of a cardiac valve prosthesis;
• - Figure 15 is similar to Figure 14, the prosthetic valve being anchored on the set of needles to abut against the clamping ring;
• FIG. 16 is similar to FIG. 15, a second clamping ring coming in abutment with the first for clamping the cardiac valve prosthesis, said second clamping ring being in the locking position to hold the set of needles in a cylindrical configuration;
• FIG. 17 is similar to Figure 16, the first clamping ring having been removed;
• FIG. 18 is similar to FIG. 17, the cardiac valve prosthesis being slid in the direction of the native ring of the heart valve;
• FIG. 19 is similar to Figure 18, the heart valve prosthesis being positioned in abutment against the native ring of the heart valve, waiting to be fixed by the knotting of the plurality of suture son.
• the present invention relates to a device (1) for securing by sutures a prosthetic heart valve (2), for example on aortic valve or a mitral valve.
• the device (1) according to the invention is intended to enter, open chest and heart, through the heart valve (5) to repair.
• the device (1) comprises a manipulating rod (3), at the end of which is arranged an assembly (4) for suturing the prosthesis (2) on the native ring of the valve (5).
• the valvular prosthesis (2) can be of any type such as a reinforcement ring, for example made of textile.
• the other end of the rod (3) is intended to cooperate with a handle, not shown, secured to control means, not shown, for example in the form of a trigger, for actuating the assembly ( 4).
• the device (1) allows for a plurality of simultaneous sutures, around the circumference of the native ring of the valve (5) in order to fix the prosthesis (2).
• the device (1) comprises a set of needles (6) held in a cylindrical configuration and connected in pairs by suture threads (7).
• the needles (6) are arranged parallel to each other, at the end of the rod (3) of manipulation, pointing to a direction opposite to the free end of the rod (3).
• the suture son (7) connecting two by two the needles (6) back along and inside the rod (3).
• the needle assembly (6) is maintained in the cylindrical configuration, on the one hand by a plurality of guides (8) and on the other hand by a plurality of pushing elements (9).
• the guides (8) are arranged to surround and enclose the pointed end of each pair of needles (6).
• two needles (6) are arranged inside a same guide (8).
• the guides (8) and needles (6) slide freely relative to each other.
• Each guide (8) is for example in the form of a sleeve comprising a cross section in the shape of eight so as to optimally maintain the needles (6) while allowing to slide along them.
• Each guide (8) is open at both ends so that the suture (7) can be released when the guide (8) is removed.
• the needles (6) are held in pairs by a plurality of push elements (9), for example in the form of sleeves comprising, in the same manner, a cross-section in the form of eight, in particular with a bottom wall for pushing each pair of needles (6).
• the bottom wall has an opening for passage of the suture (7) when the pusher member (9) is removed.
• Each pusher element (9) serves as a base adapted to maintain the non-pointed end of the needles (6), and to ensure an axial thrust force of said needles (6).
• the guides (8) and the pushing elements (9) are attached to the manipulating rod (3) by means of articulated arms (10) pivotally mounted relative to the rod (3), under the action of the means control.
• the guides (8) and pushing elements (9) are movable along the rod (3), still under the action of the control means, and can adopt a folded position along the rod (3) or an extended position spaced apart from the rod (3), in particular to increase the diameter of the cylindrical configuration of all the needles (6).
• the guides (8) and pushing elements (9) are pivotally connected to the rod (3) so as to pass, under the action of the control means, simultaneously or selectively, and independently of each other from the folded position to the extended position.
• the device (1) also comprises a protective cover (11) slidably mounted around the stem (3) to cover the pointed end of the set of needles (6) and the plurality of guides (8).
• the free end of the manipulating rod (3) is engaged through the heart valve (5), then the protective cover (11) is slid to be removed.
• the plurality of guides (8) and pushing elements (9) are displaced along the rod (3), under the action of the control means, and in particular in a direction opposite to the free end of the rod (3) so that the pointed ends of the needles (6) come close to and under the native ring of the valve (5) to be repaired.
• control means are actuated to move the guides (8) and the pushing elements (9) in the deployed position by means of the arms (10) pivoting. This makes it possible to adjust the diameter of the cylindrical configuration of the set of needles (6) to the diameter of the native ring of the valve (5) to be repaired.
• the surgeon is able to actuate the control means to move the pushing elements (9) in the direction of the guides (8).
• the set of needles (6) is pushed towards the native ring until piercing the valve (5) and fit through the first clamping ring (12).
• the clamping ring (12) comprises an outer ring (12a) pierced with a plurality of orifices (13) regularly distributed in pairs around its circumference. These orifices (13) in particular allow to receive in insertion each pair of needles (6). Each opening (13) is open and opens on the edge of the outer ring (12a), to subsequently allow the withdrawal of the clamping ring (12) and the suture son (7).
• the first ring (12) also comprises locking means in the form of an inner ring (12b), mounted coaxially in the outer ring (12a), with rotational capacity relative to the outer ring (12a).
• the rotation of the inner ring (12b) allows in particular wall portions of said inner ring (12b), to obturate, at least in part, the orifices (13) of the outer ring (12a).
• the wall portions close off the orifices (13) and fit into complementary first notches (14) that each needle ( 6).
• This makes it possible to lock the ring (12) and to keep all the needles (6) in a cylindrical configuration.
• the surgeon can actuate the control means to move the guides (8) and the pusher elements (9) along the rod (3) and towards its free end.
• the arms (10) which connect the guides (8) and the pushing elements (9) to the rod (3) can be pivoted in a folded position along the rod (3), for the removal of the rod (3) handling.
• the surgeon can now remove the set of needles (6) forming a rigid assembly extended by a bundle of sutures (7) attached to the heart valve (5).
• the suture threads (7) in the form of the bundle, can not be lost, mixed or entangled.
• the suture is fast and is performed simultaneously by all the needles (6), not one by one as in the state of the art.
• a second clamping ring (12) is positioned in abutment with the valve implant, and in particular against the support of the first clamping ring (12).
• This second clamping ring (12) is identical to the first ring and also comprises locking means in the form of an inner ring (12b) adapted to be pivoted to come to lock in complementary second notches (15) that comprise needles (6).
• the inner periphery of the inner ring (12b) of the clamping rings is crenellated in order to allow insertion of a complementary specific tool for rotating said inner ring (12b).
• the specific tool is of any appropriate type.
• valve prosthesis (2) is then slid along the needles (6) and the suture threads (7) until it bears against the native ring of the heart valve. (5) to repair.
• sutures (7) can be retrieved and tied in pairs to permanently secure the prosthesis (2) to the heart valve (5).
• the invention provides a device (1) advantageous in that it allows for simultaneous sutures through the heart valve (5), then to simultaneously remove all the suture son ( 7) in the form of a beam, which avoids mixing, losing or entangling said son (7), for their knotting two by two.
• the resulting surgical operation is greatly improved in terms of efficiency and speed.

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Surgery (AREA)
• Heart & Thoracic Surgery (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Medical Informatics (AREA)
• Molecular Biology (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Prostheses (AREA)
• Surgical Instruments (AREA)

Applications Claiming Priority (2)

Publications (1)

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• 2017
  • 2017-10-09 FR FR1759440A patent/FR3072013B1/fr not_active Expired - Fee Related
• 2018
  • 2018-08-10 US US16/648,790 patent/US20200268374A1/en not_active Abandoned
  • 2018-08-10 EP EP18766316.6A patent/EP3691547A1/de not_active Withdrawn
  • 2018-08-10 WO PCT/FR2018/052054 patent/WO2019073131A1/fr unknown

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