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    • 专利摘要:
    Device for the sterile coupling of a percutaneous surgical instrument (62) to a tool (61) for rotating said instrument, comprising a tubular connecting body (11) with a first end (111) capable of accommodating the proximal end of the instrument (62) and a second end (112) capable of receiving the end of the drive tool (61), and two retaining rings (12, 13) juxtaposed. The device comprises a casing (14) forming a flexible package secured to the holding rings and having an opening (142) for introducing the drive tool (61) into said casing (14) and inserting the endpiece end (611) thereof in the second end (112) of the device. The two retaining rings (12, 13) and the casing (14) are configured and arranged on the connecting body (11) of the device such that the connecting body (11) passes freely through the casing wall (14). ) and rotates freely with respect to the latter.
    公开号:FR3041239A1
    申请号:FR1558746
    申请日:2015-09-17
    公开日:2017-03-24
    发明作者:Laurent Fumex；Thierry Masseglia
    申请人:Laurent Fumex；Thierry Masseglia；
    IPC主号:
    专利说明:

    Device for the sterile coupling of a percutaneous surgical instrument and a training tool and method for performing such coupling.
    INVENTION The invention relates to the general field of percutaneous surgical instrumentation. In particular, it relates to percutaneous surgical instruments for traversing the epidermis and soft tissues of the body to perform, for example, bone marrow and bone tissue harvesting for biopsy purposes.
    1 ..... Έ OE l ..... INVENTION - AH> 'ANTERIOR
    In the field of percutaneous surgery and more particularly that of the percutaneous bone biopsy, it is known to use different instruments that allow both to penetrate the soft tissues and then the cortex of the bone in question and to carry out the removal of organic substances. (bone marrow, bone samples) contained in the bone or in its cavity.
    These instruments are generally known as bone biopsy needles or bone marrow needles and are generally composed of a trocar or access needle combined with a biopsy cannula. More or less perforating, trocars or access needles allow the practitioner to cross the soft tissue and drill the bone to reach an area where a bone biopsy must be performed.
    These trocars generally comprise a hollow outer tube whose end is more or less cutting, and within which slides a rod whose end is sharpened so as to perforate the bone, this rod being optionally configured to take a sample of the tissue that is in the cavity.
    Such instruments are generally implemented manually by means of a handle secured permanently or not to the proximal end (end not coming into contact with the bone) of the piercing rod, that the practitioner operates in rotation to drill the bone. In practice, the practitioner brings the end of the outer tube of the trocar into contact with the bone and then actuates the handle in rotation to penetrate the end of the rod into the bone.
    Thus, International Application published under the reference W02006 / 061514 discloses a trocar for bone biopsy comprising an outer tube, the distal end of which is divided into two segments with a helical cutting edge, in which slides a sharpened rod. This type of instrument is intended to be implemented manually by means of a handle.
    The manual implementation of such a trocar, by means of a handle directly actuated by the practitioner corresponds to a conventional procedure that allows the latter to control the fine gesture of perforation of the bone. However, in some circumstances, especially when the hardness of the bone requires greater force to penetrate the needle through the wall of the bone, it is sometimes more comfortable for both the patient and the practitioner , to have a training tool, drill type, to penetrate the rod inside the bone without applying excessive force.
    As a result there is a great advantage for the practitioner to have a trocar whose piercing rod can be operated either by means of a simple handle or via a training tool.
    Such a device advantageously allows the practitioner to start an operating procedure manually and, if the hardness of the bone requires it, to complete the perforation by means of an automatic rotational drive and without the need to change the piercing rod and therefore without risk of losing the point of entry into the bone.
    Such a possibility involves, however, having an interface device capable at one of its ends to replace the handle used by the practitioner for manual implementation of the trocar; by mounting at the end of the latter in a manner identical to the handle, and carrying at its other end an interface element on which the tip of a drive tool can be fixed removably. The device thus plays the role of a coupling element which makes it possible to drive the trocar in rotation by means of a tool.
    Such a device must, in addition, be able to ensure a relatively accurate axial positioning of the drive tool vis-à-vis the trocar, otherwise the penetration accuracy of the trocar could be affected.
    Such a possibility also implies, insofar as the interface device is intended to ensure the connection of the end of a trocar, a sterile and generally disposable object, to a drill-type tool, naturally reusable object and generally non-sterile, that the interface device can be associated in a simple manner to means for mounting the training tool at the end of the trocar and the rotational drive of said trocar avoiding any contact between the trocar and the training tool likely to cause contamination of one by the other.
    The French patent application published under the reference FR 3007636 thus describes a simple structure interface system consisting of a hexagonal male element mounted at the proximal end of the trocar and a female hexagonal element in which the male element to lodge, the assembly being secured in a detachable manner by snapping.
    This document also describes that, depending on the rotation drive means considered, the female hexagonal element is either directly integrated in the handle, or integrated in the end of an interface device directly mounted on the output shaft. of the rotating training tool (drill). In both cases the hexagonal female element advantageously retains similar morphological characteristics (polygonal section of the male and female elements) so that the end of the trocar can fit into either the handle or the end of the tool.
    This patent application thus describes a simple and inexpensive interface system, making it possible to connect a trocar to a means making it possible to actuate the trocar, handle or tool for rotating drive, the link being a detachable connection allowing precise axial alignment of the axis of rotation imposed by the actuator and the axis of the trocar. However, the coupling device described in this application does not allow as it is to perform a sterile coupling between the actuator and the trocar.
    PRESENTATION
    An object of the invention is to propose a coupling means for coupling a sterile percutaneous surgical instrument, a biopsy instrument, for example, to a tool for rotating the said instrument, the training tool being a non-functional tool. sterile, such that after coupling, the percutaneous surgical instrument assembly - training tool forms a sterile assembly. For this purpose the invention relates to a device for the sterile coupling of a percutaneous surgical instrument to a rotational drive tool, said device comprising a tubular connecting body with a first end configured to receive the proximal end of the percutaneous surgical instrument and a second end configured to receive the end of the training tool. The device according to the invention further comprises a set of juxtaposed retaining rings, arranged on the connecting body so as to be able to freely rotate about an axis coincident with the longitudinal axis of the cylindrical body, while being held axially in position. fixed position along the connecting body, and a casing forming a flexible package having a first circular opening through which the casing is threaded onto the connecting body and a second opening for introducing the drive tool into said envelope and inserting the end piece of the drive tool into the second end of the device. The two retaining rings and the casing are arranged on the connecting body of the device so that the wall of the casing having the first opening is wedged between the two retaining rings and integral with the latter, so that the connecting body of the device can pass freely through the wall of the casing and rotate freely vis-à-vis the casing.
    According to the invention, the pocket is sized and configured to be able to confine the drive means.
    According to various provisions which may be considered each separately or in combination with one or more others, the device according to the invention may have the following characteristics.
    In a particular embodiment, the two retaining rings each comprise a tubular central element mounted on the connecting body of the device and a disc-shaped flange, positioned around the surface of the central tubular element and arranged perpendicular to the longitudinal axis of the central tubular element, said flange having a substantially planar bearing face configured to bear on a corresponding flat bearing face of the flange of the other retaining ring, the wall of the casing having the first opening being pinched between these two planar faces.
    According to a particular characteristic, the bearing face of the flange of one of the holding rings comprises a set of pins and the bearing face of the flange of the other holding ring comprises a set of holes, the pins and the pins. holes being dimensioned and arranged on the respective bearing faces so that when the two faces bear against one another, the pins are inserted into the holes deforming the envelope without perforating.
    According to another particular characteristic, the connecting body of the device has at each of its ends an opening of polygonal section adapted to receive the connecting end placed at the proximal end of the percutaneous surgical instrument or the coupling end of the training means respectively.
    According to another particular characteristic, the percutaneous surgical instrument considered having a cylindrical end hexagonal section, the first end of the connecting body of the device comprises an opening of hexagonal section whose dimensions substantially correspond to those of the end of the percutaneous surgical instrument, the walls of said opening having indentations in which can snap projecting elements disposed at the connecting end of the percutaneous surgical instrument.
    According to another particular characteristic, the drive tool having a pyramid-shaped coupling end, the second end of the device connecting body comprises a truncated-pyramidal opening of hexagonal section whose dimensions are defined in such a way when the coupling end of the drive tool is inserted into the second end of the connecting body of the device, the engagement of the connecting end in the end of the connecting body is a tight fit ( without play). The invention also relates to a coupling system for the sterile coupling of a percutaneous surgical instrument, a bone biopsy instrument, for example, to a tool for rotating said instrument, comprising: a coupling device according to the invention; 'invention; - A connecting piece mounted on the proximal end of the instrument adapted to be inserted into the first end of the connecting body of the coupling device; - A coupling end mounted on the drive end of the drive tool adapted to be inserted into the second end of the connecting body of the coupling device. The connecting end and the coupling end are configured and dimensioned to engage tightly in the first end and the second end of the connecting body of the coupling device respectively, so that the axis of the coupling percutaneous surgical instrument and the axis of the output shaft of the drive tool are substantially merged.
    According to various arrangements which may be considered each separately or in combination with one or more others, the coupling system according to the invention may have the following characteristics.
    According to a particular embodiment, the coupling end of the drive tool comprises a body of truncated-pyramidal shape of hexagonal section coupled by its vertex to a cylindrical end element forming a positioning flange and the second end of the coupling device comprises an opening having a truncated-pyramidal cavity shaped hexagonal section, adapted to accommodate the truncated-pyramidal body of the coupling end and opening on a cylindrical cavity shaped area adapted to accommodate the end element, a diameter substantially equal to the diameter of said end member.
    According to a particular technical characteristic, the coupling system according to the invention comprises a locking mechanism constituted by a set of peripheral notches formed in the wall of the cavity of the coupling device and by a retractable locking element, integral with the endpiece. coupling of the drive tool configured to wedge into at least one of the notches when the coupling tip is inserted into the coupling device and to hold the coupling end in place in the end of the coupling device.
    According to another particular technical characteristic, the retractable locking element is formed of a semi-opening radial cylindrical duct formed in the truncated-pyramidal body of the coupling end of the drive tool, in which a ball and a spiral spring, arranged in the cylindrical conduit such that the spring tends to push the ball outwardly of the conduit.
    According to another particular technical characteristic, the axis of the radial cylindrical duct forms with the axis of symmetry of the body of the coupling end of the drive tool an acute angle, the open end of said duct being directed towards the top the body of the mouthpiece.
    According to another particular technical characteristic, the second end of the coupling device comprising a truncated-pyramidal shape cavity with a hexagonal cross-section, the coupling end of the drive tool comprises a truncated-pyramidal shape body of hexagonal cross-section of which the angle of opening is greater than the opening angle of the cavity, the dimensions of the body section of the coupling tip being defined such that when it is fully inserted into the end of the device it is wedged against the walls of the truncated-pyramidal cavity at the inlet orifice of the cavity. The invention also relates to a method for performing the sterile coupling of a percutaneous surgical instrument, a biopsy instrument for example, and a drive tool of said instrument by means of a coupling device such as defined above, the method comprising the following phases: - A preliminary phase of reversal of the device envelope on itself this step being performed by pushing the first end of the coupling device inside the envelope until the second end emerges from the envelope through the second opening; a first phase during which the coupling end of the drive tool is introduced into the second end of the coupling device, and during which the casing is shaped so that it encloses the tool training then hermetically closes the second opening of the envelope; a second phase during which the percutaneous surgical instrument is put in place by inserting the connecting end of said instrument into the first end of the coupling device.
    According to a particular mode of implementation of the method according to the invention, the first phase comprises the following steps: a first assembly step during which the practitioner, equipped with sterile gloves, grasps the first end of the coupling device, while that the coupling end of the drive tool is inserted into the second end of the coupling device; the coupling device - driving tool being maintained by the practitioner such that the coupling device is placed in a vertical position, the training tool overhanging the hand of the practitioner; a second assembly step during which the practitioner slides the wall of the envelope along the body of the drive tool until the envelope encloses the tool in its entirety; - A third assembly step during which the practitioner closes the second opening of the envelope with the closing means disposed at said opening;
    i;,! - 'SCWW; DAÎ β λ λ .y} 3URES
    The features and advantages of the invention will be better appreciated thanks to the description which follows, a description which is based on the appended figures which show: - the figurel, a schematic side view of the coupling device according to the invention, in a form particular embodiment taken as an example; - Figures 2 to 6, schematic views illustrating the various elements constituting the coupling device according to the invention in a preferred embodiment and the principle of assembly of these elements together; FIGS. 7 and 8 are diagrammatic views illustrating the principle of assembling the coupler according to the invention with a drive tool having a suitable end piece; FIG. 9, a schematic view showing a coupling interface between the driving tool and the coupling device, in a preferred embodiment; - Figure 10, a partial schematic side view showing the coupling device according to the invention and the tip of the drive tool inserted into the coupling device; - Figure 11, a partial sectional view showing the end of the body of the coupling device according to the invention and the tip of the drive tool inserted into this end.
    It should be noted that in the different figures, two structurally or functionally identical elements are assigned a same reference.
    DETAILED DESCRIPTION
    For the sake of clarity of the description, the following description presents the various characteristics of the coupling device according to the invention through a particular embodiment taken as an example and its use to achieve the sterile coupling of a biopsy instrument to a training tool. However, it is understood that the scope or scope of the invention is not limited to this single embodiment and use.
    Figure 1 shows a schematic side view of the coupling device according to the invention.
    It mainly comprises a cylindrical body 11, or connecting body, having two ends, a first end 111 having a cavity for receiving the connecting end 621 of a biopsy instrument 62 and a second end 112 having a cavity intended to receive the coupling end 611, or nose, of a drive tool 61.
    The device according to the invention also comprises two retaining rings 12 and 13 arranged around the cylindrical body.
    As illustrated in FIGS. 2 to 5, each of the rings 12 and 13 has a tubular portion 121 or 131 disposed around the cylindrical body 11 and a disc-shaped flange 122 or 132, extending radially around the tubular portion 121. or 131 at one end of the latter and disposed perpendicularly to the axis of symmetry of the tubular portion.
    Each flange, 122 or 132, having a flat end face, 123 or 133, the two rings 12 and 13 are designed to be arranged relative to each other so that their planar faces clamp the 14 envelope when the two rings are assembled to one another and mounted on the connecting body.
    The device according to the invention further comprises a bag-shaped envelope 14 intended to serve as a housing for the drive tool when it is coupled to the device according to the invention by the second end 112. This envelope 14 has a first circular opening 141, visible in Figure 4, through which passes the connecting body 11 and a second opening 142, visible in Figure 7, of larger size, by which we can introduce the tool of training 61 in the envelope 14.
    According to a preferred embodiment, the diameter of the circular opening 141 of the casing 14 is smaller than the diameter of the circular portion 131 of the ring 13 to seal between the sterile and non-sterile areas.
    According to the invention, the envelope 14 is arranged vis-à-vis the two retaining rings 12 and 13, so that when the two rings are assembled to one another, the wall of the envelope 14 is sandwiched and clamped between the two faces 123 and 133 of the rings 12 and 13, as illustrated by Figure 1 and Figures 3 and 6. The casing 14 is thus integral with the two retaining rings 12 and 13.
    The two rings 12 and 13 are configured so that; when they are assembled and mounted on the connecting body 11, it can rotate freely on itself, that is to say without causing the rotation of the rings and the envelope attached thereto.
    Furthermore, the two retaining rings 12 and 13 as well as the connecting body are also configured so that the two retaining rings 12 and 13 can be assembled together to form a single piece that can be rotated. around the connecting body 11 but locked in translation at a given position along the connecting body, as shown in FIG. 1.
    Figures 2 to 5 show the various constituent elements of the coupling device 10 according to the invention, in a preferred embodiment. For the sake of clarity, FIGS. 4 and 5 show the various elements of the device with the exception of the pocket 14.
    In this embodiment, the connecting body 11 is constituted by a cylindrical element having a first and a second end 111 and 112 each having an opening 113 and 114 for respectively receiving the end of the biopsy instrument and the coupling end of the training tool.
    The connecting body 11 also has an annular shoulder 115 protruding on its outer surface and dividing the connecting body into two sections, and a groove 116 formed in the wall between the shoulder 115 and the second end 112 of the body of the body. link 11.
    The first retaining ring 12 is constituted, as illustrated in FIGS. 4 and 5, of a tubular central element 121 around which is positioned a disk-shaped flange 122 in a plane perpendicular to the axis of the element. tubular 121.
    The first retaining ring 12 also preferably comprises reinforcing elements 123 intended to stiffen the assembly of the flange 122 on the central element 121. These reinforcing elements 123 are arranged radially on the surface of the central element 131 and bear on the face of the flange opposite to the contact face 126.
    In this embodiment, the second retaining ring 13 is also formed, as also illustrated in FIGS. 4 and 5, of a tubular central element 131 around which is positioned a disk-shaped flange 132, arranged in a perpendicular plane. to the axis of the tubular element 131, so that the tubular element 131 passes completely through the flange 132.
    It also preferably comprises reinforcing elements 133 intended to stiffen the assembly of the flange 132 on the central element 131. These reinforcing elements are arranged radially on the surface of the central element 131 and rest on the one side of the flange. The other side of the flange forming the bearing face 136 of the second ring.
    It further comprises an internal annular shoulder 134, disposed on the inner wall of the central tubular element 131 and projecting into the internal space delimited by the wall of the central element 131, as illustrated in FIG. 4.
    It also comprises an annular groove 137 formed in the thickness of the wall of the central tubular element 131, on the external face thereof, in the portion of this element situated on the side of the bearing face 136 of the 132. From a dimensional point of view, the inside diameter of the central tubular element 131 of the second retaining ring 13 is substantially equal, with a functional clearance, to the outside diameter of the connecting body 11 in the zone delimited by the shoulder 115 and the second end 112 of the connecting body 11.
    In addition, the length of the central tubular element 121 of the first retaining ring 12, as well as the length of the central tubular element 131 of the second retaining ring 13 and the position of the flange 132 along this element, are defined such that when the ring 13 is threaded onto the connecting body 11 by the second end 112, until it comes into contact with the shoulder 115, the bearing face 136 being oriented towards the first end 111 of the connecting body, the end 138 of the ring opposite the bearing face 136 approaches the second end 112 of the connecting body 11.
    Furthermore, the thickness of the shoulder 134 disposed on the inner surface of the central tubular element 131 and the position of said shoulder relative to the ends of the central tubular element are defined so that the latter is housed in the groove 116 formed in the thickness of the wall of the connecting body 11 when the second retaining ring is threaded onto the holding body until it comes into contact with the shoulder 115. From a dimensional point of view also , the inner diameter of the central tubular element 121 of the first retaining ring 12 is substantially equal, with a functional clearance close, to the outside diameter of the central tubular element 131, the second retaining ring 13, in the zone facing the bearing face 136.
    In this way the first retaining ring 12 can be inserted on the tubular element 131 of the second ring 13 to bring the bearing faces 126 and 136 in contact with the wall of the casing 14 in order to tighten it.
    The holding in place is then provided by the annular shoulder 124 projecting from the inner wall of the central tubular element 121 of the first retaining ring 12, shoulder dimensioned and positioned along the wall so that when the first retaining ring 12 is completely inserted on the central element 131 of the second ring 13, the two bearing faces 126 and 136 being in contact with the wall of the casing 14, the annular shoulder 124 is housed in the groove 139 of the second retaining ring 13.
    In a preferred embodiment of the coupling device according to the invention, illustrated by the schematic longitudinal sectional view of FIG. 6, the profile of the groove 116 and the shape of the cross section of the shoulder 134 are defined as such. so that when the second ring is completely inserted on the connecting body, as shown in Figure 5, the shoulder 134 opposes some resistance to the withdrawal of the second retaining ring 13 of the connecting body 11. In this way, advantageously , the second retaining ring 13 remains naturally in place on the connecting body 11.
    Likewise, the profile of the groove 137 and the shape of the cross-section of the shoulder 124 are defined in such a way that when the first ring 12 is completely inserted on the central tubular element of the second ring 13, as illustrated in FIG. 3, the shoulder 124 opposes a certain resistance to the withdrawal of the first retaining ring 12 of the central tubular element of the second ring 13. In this way, advantageously, the first retaining ring 12 remains naturally in place on the second retaining ring 13.
    It should be noted that insofar as one of the technical features of the invention consists in the fact that the connecting body 11 freely rotates about its axis inside the duct formed by the central element 131 of the second retaining ring 13, the inner diameter of the element 131 and the outer diameter of the connecting body 11 are defined over the entire contact zone between these two elements, so as to provide a functional clearance allowing the connecting body 11 to to move freely in rotation while being held in place longitudinally vis-à-vis the second retaining ring 13 through the shoulders 115 and 134.
    On the other hand, the shoulder 124 of the central element of the first retaining ring 12 and the groove 137 of the second retaining ring are dimensioned so that, once in place, they maintain the faces of the retaining ring in contact with each other. contact 126 and 136 of the two rings against the wall of the casing 14.
    It should also be noted that due to the dimensional and functional constraints described in the previous paragraph, the assembly of the second retaining ring 12 on the connecting body 11 and that of the first retaining ring 12 on the second retaining ring 13 requires, due to the presence of the shoulders 124 and 134, a force insertion which causes a slight deformation stress on the tubular elements 121 and 131 of the rings.
    This constraint however ceases when the shoulders 124 and 134 are positioned in the grooves 137 and 115 respectively. Therefore, according to the invention the retaining rings 12 and 13 are preferably made of a deformable material and capable of returning to its original shape after deformation.
    Thus, in this preferred embodiment, illustrated in FIGS. 4 to 6, the assembly of the coupling device 10 according to the invention can advantageously be achieved by simple fitting, as illustrated by FIGS. 2 and 3.
    To do this, the first retaining ring 13 is firstly inserted on the connecting body 11 until the end of the central tubular element 131 comes into contact with the shoulder 115.
    Then, in a second step, inserting the first end of the connecting body 11 through the first circular opening of the envelope 14 to bring the wall of the envelope into contact with the bearing face 136 of the second retaining ring 13.
    Then finally, in a third step, inserting the first retaining ring 12 on the central tubular element 131 of the second ring 13 to bring the bearing face 126 of the first ring into contact with the wall of the envelope 14.
    In this way, the wall of the envelope 14 is trapped and pressed between the two bearing faces 126 and 136.
    The successive placements of the shoulders 134 and 124 in the respective grooves 116 and 137 then ensure the locking position of the assembly.
    It should be noted that, in addition to keeping in place the various elements that constitute it, the structure of the device according to the invention advantageously makes it possible, in this preferred embodiment, to guarantee a seal between the zone of the space limited by the 14 envelope and likely to contain non-sterile material (the training tool in particular) and the rest of the space in which the device is implemented, space by sterile principle.
    Indeed the presence of the shoulders and grooves described in the preceding paragraphs is advantageously translated, during the assembly of the various elements of the coupling device 10 according to the invention, by the constitution of annular baffles at the ducts formed by the elements. tubular 121 and 131, baffles that hinder, or even make unlikely, a possible flow of non-sterile materials to the sterile areas.
    It should also be noted, as illustrated in particular in FIGS. 4 to 6, that in order to reinforce the tear resistance of the casing 14 between the contact faces 126 and 136 of the two retaining rings 12 and 13 , the faces 126 and 136 may be provided, in a particular embodiment, a set of pins 125 and cavities 135, or holes, arranged on these two faces; the pins 125 being, for example, all arranged on the contact face 126 of the first retaining ring 12 and the cavities 135 on the contact face 136 of the second retaining ring 13.
    The shape and arrangement of the cavities and the pins are then defined so that, during the assembly of the two retaining rings 12 and 13, the lugs 125 arranged on one of the contact faces, come to fit together in the cavities 135 formed in the other contact face deforming the wall of the casing 14 without perforating thereby increasing the resistance to radial tearing. This embodiment avoids the heat-sealing or gluing of the casing 14 on a contact face 126 or 136 of the rings 12 or 13, making the operation less expensive.
    As has been said previously, the function of the connecting body 11 of the device 10 according to the invention is to provide a mechanical interface between the proximal end of a biopsy instrument and the coupling end of a tool enabling in motorized rotation of the biopsy instrument. The proximal end of the biopsy instrument here corresponds to the end by which the practitioner grasps and implements the instrument. For this purpose it comprises at each of its ends 111 and 112 interface means adapted to the biopsy instrument and the rotating tool considered. The invention therefore naturally relates to a sterile coupling system between a biopsy instrument and a tool for rotating said instrument, the system comprising the coupling device 10 previously exposed as well as the connecting end of the biopsy instrument at device and that the coupling end of the rotating tool to the device.
    Such a system is of course adapted to a biopsy instrument having an end on which is disposed a tip for mounting on the instrument, removably, various means allowing the practitioner to turn the instrument. The end piece may for example take the form of a hexagonal base cylinder intended to be housed in a cylindrical cavity with hexagonal walls formed in the rotation means considered. The length of the tip, the depth of the cavity, as well as the dimensions of the sections of the tip and the cavity are defined so that the biopsy instrument and the rotating means are assembled together. to the other without play, so that the implementation of said means, handle or rotary bit tool, by the practitioner causes a rotation of the instrument on itself around its axis of symmetry and a penetration of the instrument in a substantially rectilinear direction.
    In the context of a sterile coupling system, the connecting body 11 of the coupling device according to the invention 10 has at its first end 111, as illustrated in FIG. 5, a cavity 113 having a geometry and dimensions adapted to the end tip of the biopsy instrument considered, a cylindrical cavity with hexagonal wall, of appropriate section and length, for example.
    In a preferred embodiment, the wall of the cavity 113 also comprises means to ensure, out of any action of the practitioner, the holding in place of the connecting end 621 of the biopsy instrument 62 in the cavity of the connecting body 11. These means may for example consist, as illustrated in FIG. 5, in peripheral notches 117 intended to receive elastic lugs 622 arranged laterally on the connecting end 621 of the instrument 62.
    Furthermore, the connecting body 11 of the coupling device according to the invention has, at its second end 112, a cavity 114 whose shape and dimensions are adapted to receive the coupling end of the rotating tool considered. .
    According to the invention, the coupling end of the rotating tool and the cavity of the connecting body 11 are configured and dimensioned in such a way that when the coupling end of the tool is put in place in the cavity 114 of the connecting body 11 of the coupling device intended for this purpose, the axis of rotation of the coupling end and the axis of rotation of the connecting body 11 are combined and that in the absence of action of the practitioner, the rotating tool remains attached to the coupling device by its tip.
    FIGS. 7 to 11 illustrate, as a preferred embodiment, a particular mode of coupling of a rotating tool 61 and a coupling device 10 according to the invention allowing the sterile coupling of said tool 61 to a Biopsy instrument 62 (shown partially in Figures 7 and 8). The tool 61 here comprises a handle 612 secured to a main body 613 enclosing an electric motor adapted to rotate a transmission shaft. At the end of this shaft is fixed a coupling end 611, intended to be housed in the cavity formed at the second end 112 of the connecting body 11 of the coupling device according to the invention. The set has the known form of a hand drill.
    In this preferred embodiment, the coupling end 611 of the tool 61, shown in the view 9-B of FIG. 9, comprises a body 91 of generally truncated-pyramidal shape with a hexagonal base, capped at its apex by an end element 92 in the form of a cylinder of revolution of small width.
    The diameter of the end element 92 is slightly smaller than the diameter of the cylindrical cavity 97 of the connecting body 11. The end 112 of the connecting body 11 of the coupling device according to the invention has, for its part, as illustrates the view 9-A of Figure 9, a cavity 114 having a first zone 95 of generally truncated pyramidal shape, with flat walls whose hexagonal base constitutes the opening of the cavity. This truncated-pyramidal portion, intended to receive the truncated-pyramidal body 91 of the tip 611, opens onto a second cylindrical zone 97 intended to receive the end element 92 of the same endpiece. The wall 96 makes it possible to separate the sterile and non-sterile zones of the connecting body 11.
    The dimensions and the geometry (angle at the top) of the truncated-pyramidal zone 95, as well as the diameter and the height of the cylindrical zone 97 are defined so that the coupling endpiece 611 can be inserted into the cavity 114, the end member 92 being housed in the cylindrical zone 97, as shown in FIG. 10.
    The particular structure of the coupling tip 611, constituted by a truncated-pyramidal body 91 terminated by a cylindrical end element 92, associated with the corresponding structure of the cavity 114, namely a hollow structure comprising a truncated-pyramidal cavity 95 extended by a cylindrical cavity 97, advantageously allows to perform two functions simultaneously.
    The first function is to ensure a satisfactory interlocking of the coupling end 611 of the drive tool 61 at the end of the coupling device 10, interlocking provided by the associated truncated pyramidal portions 91 and 95.
    The second function consists in ensuring an automatic alignment of the axis of rotation of the coupling tip 611 on the axis of rotation of the connecting body 11 of the device, itself coincident with the axis of rotation of the biopsy tool 62, alignment provided by the associated cylindrical portions 92 and 97.
    In this preferred embodiment, the interface formed by the coupling bit 611 and the cavity 114 includes means allowing, when the rotating tool 61 is inserted into the end 112 of the coupling device 10 according to the invention. invention, to ensure, in the absence of voluntary action of the practitioner, a holding in position of the drive tool 61.
    These means are constituted, as illustrated by the schematic view in partial section of FIG. 11, on the one hand by a slight difference, a, of inclination with respect to the common axis of symmetry, of the walls forming the truncated zone. pyramidal 95 of the cavity 114 and the walls forming the truncated-pyramidal body 91 of the tip 611.
    They are, on the other hand, constituted by a snap locking mechanism itself constituted for example, as illustrated in FIG. 11, by a set of peripheral notches 98 formed in the wall of the cavity 114 and by an element retractable locking device 1101, secured to the endpiece 611.
    This tip is configured to become jammed in at least one of the notches 98 when the coupling end (611) of the drive tool (61) is inserted into the coupling device (10) and ensure the maintenance in place the tip (611) in the end (112) of the coupling device (10).
    In the particular embodiment illustrated in FIG. 11, the locking element is constituted by a ball pusher 1101 comprising a semi-opening radial cylindrical duct 1103 formed in the truncated-pyramidal body 91 of the coupling endpiece 611. , in which are placed a ball 1102 and a spiral spring 1104, arranged in the cylindrical conduit 1103 so that the spring 1104 tends to push the ball (1102) outwardly of the conduit 1103.
    Preferably, the locking element is also arranged so as to naturally favor the retention of the retractable end in the slot 98 in which it is placed by a contact of the ball (1102) against the outer wall of the notch 98 In the example of FIG. 11, for this purpose, the axis of the radial cylindrical duct (1101) forms an acute angle with the axis of symmetry of the body 91 of the coupling endpiece 611 of the tool. training 61; the open end of said duct being directed towards the top of the body 91 of the nozzle.
    Advantageously, the introduction of such means prevents, or at least strongly limit, the possibility of a spontaneous uncoupling of the rotating tool 61 and the coupling device 10 according to the invention.
    The coupling device 10 according to the invention, as described in detail in the preceding paragraphs, has the function of enabling a sterile coupling to be made between a biopsy instrument on a sterile basis, discarded after use, and a tool rotation of said instrument reusable tool several times and that its structure makes it difficult to make completely sterile. It is for this purpose that the coupling device according to the invention comprises a flexible casing 14, preferably translucent, intended to confine the rotating tool while allowing its handling and its use, as shown in FIG. 8 .
    This flexible bag 14 comprises, in addition to the first circular opening 141 described above and intended to allow the connecting body 11 to pass through its wall, a second opening 142 for introducing the rotating tool 61.
    This second opening 142 is further dimensioned so as to allow a reversal of the wall of the casing 14 on itself, the inner wall of the casing 14 then being turned towards the outside, and thus being able to push out of the casing the second end 112 of the connecting body 11, normally housed inside this casing.
    In this way, it is advantageously possible to access this end 112 without coming into contact with the outer wall of the envelope 14.
    The edge of the opening 142 is furthermore configured and provided with means making it possible to seal the envelope which prevents any direct contact of the rotating tool 61 with sterile elements when the latter is placed in the envelope and coupled to a biopsy instrument.
    Given the technical characteristics of the coupling device according to the invention, it is advantageously possible to perform in a simple manner a removable coupling of a motorized rotational tool 61, a non-sterile tool, to a biopsy instrument that is necessarily sterile, without risking inadvertently contaminating the sterile medium during the coupling operation or the reverse separation operation.
    As a result, the sterile coupling operation of a biopsy instrument and a drive tool of said instrument by means of a coupling device according to the invention can be described by the following implementation phases: preliminary turnaround of the casing 14 of the device 10 on itself, this step being performed by pushing the first end of the device 111 of the coupling device inside the casing 14 until the second end 112 emerges from the envelope through the second opening 142; a first phase during which the tip 611 of the drive tool 61 is introduced into the cavity 114 of the second end 112 of the coupling device 10, and during which the envelope is shaped so that it encloses the tool 61 for rotating 61, then hermetically closing the second opening 142 of the envelope; a second phase during which the biopsy instrument 62 is put in place by inserting the end of said instrument into the cavity 113 of the first end 111 of the coupling device 10.
    According to the invention, the preliminary phase can be either independently implemented at the time of manufacture of the coupling device according to the invention, the device is then delivered to the practitioner in sterile packaging with its envelope 14 prérétournée; is implemented by the practitioner just before use, the device then being delivered in sterile packaging with its envelope not returned on itself.
    According to the invention also, the first phase of the coupling operation comprises several steps which according to the equipment and the support staff available to the practitioner can be implemented in different ways.
    Thus, during a first assembly step, the coupling device according to the invention with its casing previously returned being held in a vertical position (the second end 112 of the device 10 being directed upwards), the coupling end is introduced. 611 of the drive tool 61 in the second end 112 of the coupling device, so that the tool 61 is held in vertical position by the coupling device 10.
    This step may for example be carried out by the practitioner equipped with sterile gloves, which grips the first end 111 of the coupling device, while the tip 611 of the drive tool 61 is inserted into the second end 112 of the coupling device, for example by a support staff. The coupling device - driving tool assembly is then maintained by the practitioner such that the coupling device is placed in a vertical position, the training tool overhanging the hand of the practitioner.
    Then, during a second assembly step, the wall of the envelope 14 is slid on itself around the body of the drive tool 61 until, returning to its original shape, the envelope 14 encloses the tool 61 in totality.
    This second step may for example be performed by the practitioner himself who grasps one end of the envelope 14 and then raises it by sliding the folded outer wall of the envelope so as to gradually wrap the body of the tool. 61, taking care, however, that his fingers do not come into contact with the body of the drive tool until the envelope 14 returns to its original shape.
    Then, during a third assembly step, the second opening 142 of the envelope 14 is closed by means of the closing means arranged at the level of said opening. This step can also be performed by the practitioner himself, insofar as the rotation tool 61 is then housed in the envelope 14.
    Finally, according to the invention, the second phase of the coupling process consists, for the practitioner, of grasping the coupling device assembly 10 - drive tool 61 by the training tool, then covered with the envelope, and insert the connecting tip of the biopsy instrument 62 into the second end of the coupling device. At the end of the first phase, the practitioner has a sterile rotational tool that he can at will to couple to a biopsy instrument by proceeding to the second phase, then decouple said instrument to substitute a simple handle with which he can rotate the biopsy instrument without mechanical assistance.
    权利要求:
    Claims (15)
    [1" id="c-fr-0001]
    Apparatus for sterile coupling of a percutaneous surgical instrument (62) to a rotational driving tool (61) of said instrument (62), said device comprising a tubular connecting body (11) with a first end (111) ) configured to receive the proximal end of the instrument (62) and a second end (112) configured to receive the end of the drive tool (62), characterized in that it further comprises an assembly of retaining rings (12, 13) juxtaposed, arranged on the connecting body (11) so as to rotate freely about an axis coincident with the longitudinal axis of the cylindrical body (11), while being held axially in fixed position along the connecting body (11), and a casing (14) forming a flexible package having a first circular opening (141) through which the casing is threaded onto the connecting body (11) and a second opening (14 2) for introducing the drive tool (61) into said housing (14) and inserting the end fitting (611) of the drive tool (61) into the second end (112). ) of the device; the two retaining rings (12, 13) and the casing (14) being arranged on the connecting body (11) of the device such that the wall of the casing (14) having the first opening (141) is wedged between the two holding rings (12, 13) and integral with the latter, so that the connecting body (11) of the device can pass freely through the wall of the casing (14) and rotate freely vis-à-vis -vis the envelope.
    [2" id="c-fr-0002]
    2. Device according to claim 1, characterized in that the pocket (14) is dimensioned and configured to be able to confine the drive means (61).
    [3" id="c-fr-0003]
    3. Device according to one of claims 1 or 2, characterized in that the two retaining rings (12, 13) each comprise a tubular central element (121, 131) mounted on the connecting body (11) of the device and a disk-shaped flange (122, 132) positioned around the surface of the central tubular element (121, 131) and arranged perpendicularly to the longitudinal axis of the central tubular element (121, 131), said flange (122, 132) having a substantially flat bearing face (126, 136) configured to rest on a corresponding flat bearing face of the flange of the other retaining ring, the wall of the casing (14) having the first opening (141) being pinched between these two planar faces (126, 136).
    [4" id="c-fr-0004]
    4. Device according to claim 3, characterized in that the bearing face (126) of the flange (122) of one of the retaining rings (12) comprises a set of pins (125) and that the face of support (136) of the flange (132) of the other retaining ring (13) comprises a set of holes (135), the pins and the holes being dimensioned and arranged on the respective bearing faces so that when the two faces are supported on one another, the pins (125) are inserted into the holes (135) deforming the casing (14) without perforating.
    [5" id="c-fr-0005]
    5. Device according to one of the preceding claims, characterized in that the connecting body (11) of the device has at each of its ends an opening (113, 114) of polygonal section adapted to accommodate the connecting end (621 ) placed at the proximal end of the percutaneous surgical instrument (62) or the coupling end (611) of the drive means (61) respectively.
    [6" id="c-fr-0006]
    6. Device according to one of the preceding claims, characterized in that the percutaneous surgical instrument (62) considered having a cylindrical end of hexagonal section, the first end (111) of the connecting body (11) of the device comprises an opening (113) of hexagonal section whose dimensions correspond substantially to those of the end of the percutaneous surgical instrument (62), the walls of said opening (113) having notches (115) in which can snap protruding members (622) disposed at the connecting end (621) of the percutaneous surgical instrument (62).
    [7" id="c-fr-0007]
    7. Device according to one of the preceding claims, characterized in that the drive tool (61) comprising a coupling piece (611) in the form of a truncated pyramid, the second end (112) of the connecting body ( 11) of the device comprises a truncated-pyramidal opening (114) of hexagonal cross-section, the dimensions of which are defined in such a way that when the coupling end (611) of the driving tool (61) is inserted into the second end (112) of the connecting body (11) of the device, the engagement of the connecting piece (611) in the end of the connecting body (11) is a tight interlock (without play).
    [8" id="c-fr-0008]
    A coupling system for sterile coupling of a percutaneous surgical instrument (62) to a rotational driving tool (61) of said instrument (62), comprising: - a coupling device (10) according to any one of claims 1 to 7; - a connecting piece (621) mounted on the proximal end of the percutaneous surgical instrument (62) adapted to be inserted into the first end (111) of the connecting body (11) of the coupling device (10); - A coupling end (611) mounted on the driving end of the drive tool (61) adapted to be inserted into the second end (112) of the connecting body (11) of the coupling device (10); the connecting end (621) and the coupling end (611) being configured and dimensioned to fit snugly into the first end (111) and the second end (112) of the connecting body (11). coupling device respectively, such that the axis of the percutaneous surgical instrument (62) and the axis of the output shaft of the drive tool (61) are substantially merged.
    [9" id="c-fr-0009]
    9. Coupling system according to claim 8, characterized in that the coupling end (611) of the drive tool (61) comprises a body (91) of truncated-pyramidal shape of hexagonal section coupled by its top a cylindrical end member (92) forming a locating flange and the second end (112) of the coupling means having an opening (114) having a truncated-pyramidal cavity sectional area (95) hexagonal, adapted to receive the truncated-pyramidal body (91) of the coupling end (611) and opening on a zone (97) in the form of a cylindrical cavity adapted to receive the end element (92), a diameter substantially equal to the diameter of said end member.
    [10" id="c-fr-0010]
    10. Coupling system according to claim 8 or 9, characterized in that it comprises a locking mechanism consisting of a set of peripheral notches (98) formed in the wall of the cavity (114) of the coupling device (10). ) and by a retractable locking element (1101), integral with the coupling end (611) of the drive tool (61), configured to become wedged in at least one of the notches (98) when the coupling tip (611) is inserted into the coupling device (10) and ensuring that the coupling end (611) is held in place in the end (112) of the coupling device (10).
    [11" id="c-fr-0011]
    11. Coupling system according to claim 10, characterized in that the retractable locking element (1101) is formed of a semi-opening radial cylindrical duct (1103) formed in the truncated-pyramidal body (91) of the coupling end (611) of the driving tool (61), in which are placed a ball (1102) and a spiral spring (1104), arranged in the cylindrical conduit (1103) so that the spring (1104) tends to push the ball (1102) towards the outside of the conduit.
    [12" id="c-fr-0012]
    12. Coupling system according to claim 11, characterized in that the axis of the radial cylindrical duct (1101) forms with the axis of symmetry of the body (91) of the coupling end (611) of the tool d driving (61) an acute angle, the open end of said conduit being directed towards the top of the body (91) of the nozzle.
    [13" id="c-fr-0013]
    13. Coupling system according to any one of claims 8 to 11, characterized in that the second end (112) of the coupling device (10) having a cavity (95) of truncated-pyramidal shape hexagonal section, coupling end (611) of the driving tool (61) comprises a body (91) of truncated-pyramidal shape of hexagonal section whose opening angle is greater than the opening angle of the cavity (95), the dimensions of the body section of the coupling hub (611) being defined so that when it is fully inserted into the end (112) of the coupling device (10) it is stuck against the walls of the truncated-pyramidal cavity (95) at the inlet port of the cavity.
    [14" id="c-fr-0014]
    Method for sterile coupling of a percutaneous surgical instrument (62) and a training tool (61) of said instrument by means of a coupling device (10) according to one of the preceding claims, characterized in that it comprises the following phases: - A preliminary phase of reversal of the envelope (14) of the device on itself this step being carried out by pushing the first end (111) of the coupling device inside of the envelope (14) until the second end (112) emerges from the envelope (14) through the second opening (142); a first phase during which the coupling end (611) of the drive tool (61) is introduced into the second end (112) of the coupling device, and during which the casing (14) is reshaped; ) so that it encloses the drive tool (61) and then hermetically closes the second opening (142) of the casing (14); a second phase during which the percutaneous surgical instrument (62) is put in place by inserting the connecting end (621) of said instrument into the first end (111) of the coupling device (10).
    [15" id="c-fr-0015]
    15. A method of assembly according to claim 14, characterized in that the first phase comprises the following steps: a first assembly step during which the practitioner, equipped with sterile gloves, grasps the first end (111) of the device; coupling (10), while the coupling end (611) of the driving tool (61) is inserted into the second end (112) of the coupling device (10), the coupling device-tool assembly the training device being held by the practitioner such that the coupling device (10) is placed in a vertical position, the training tool (61) overhanging the practitioner's hand; a second assembly step during which the practitioner slides the wall (14) of the envelope along the body of the training tool (61) until the envelope encloses the tool in its entirety ; - A third assembly step during which the practitioner closes the second opening (142) of the casing (14) with the closure means disposed at said opening.
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    同族专利:
    公开号 | 公开日
    WO2017046531A1|2017-03-23|
    FR3041239B1|2021-12-10|
    引用文献:
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    US20150173841A1|1996-12-12|2015-06-25|Intuitive Surgical Operations, Inc.|Disposable Sterile Surgical Adaptor|
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    WO2018229773A1|2017-06-16|2018-12-20|Xact Robotics Ltd.|Drape adaptor|US5792045A|1994-10-03|1998-08-11|Adair; Edwin L.|Sterile surgical coupler and drape|
    FR3007636B1|2013-07-01|2016-09-02|Laurent Fumex|TROCART PERFORANT.|JP6946467B2|2017-05-12|2021-10-06|デビコー・メディカル・プロダクツ・インコーポレイテッドＤｅｖｉｃｏｒ Ｍｅｄｉｃａｌ Ｐｒｏｄｕｃｔｓ， Ｉｎｃ．|Biopsy device with sterile sleeve|
    EP3843641A1|2018-08-31|2021-07-07|Pro-Dex, Inc.|Surgical tool attachment devices, systems, and methods|
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    法律状态:
    2016-09-21| PLFP| Fee payment|Year of fee payment: 2 |
    2017-03-24| PLSC| Publication of the preliminary search report|Effective date: 20170324 |
    2018-03-12| PLFP| Fee payment|Year of fee payment: 3 |
    2018-09-24| PLFP| Fee payment|Year of fee payment: 4 |
    2019-09-26| PLFP| Fee payment|Year of fee payment: 5 |
    2020-09-14| PLFP| Fee payment|Year of fee payment: 6 |
    2021-09-21| PLFP| Fee payment|Year of fee payment: 7 |
    优先权:
    申请号 | 申请日 | 专利标题
    FR1558746A|FR3041239B1|2015-09-17|2015-09-17|DEVICE FOR THE STERILE COUPLING OF A PERCUTANE SURGICAL INSTRUMENT AND A TRAINING TOOL AND METHOD FOR PERFORMING SUCH COUPLING|FR1558746A| FR3041239B1|2015-09-17|2015-09-17|DEVICE FOR THE STERILE COUPLING OF A PERCUTANE SURGICAL INSTRUMENT AND A TRAINING TOOL AND METHOD FOR PERFORMING SUCH COUPLING|
    PCT/FR2016/052335| WO2017046531A1|2015-09-17|2016-09-15|Device for the sterile coupling of a percutaneous surgical instrument and of a driving tool, and method for producing such a coupling|
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