Coupler and surgical device with a collar for covering a sterile flexible sheath
Patent Information
- Application Number
- FR2020001807
- Authority / Receiving Office
- FR · FR
- Patent Type
- Patents
- Current Assignee / Owner
- Filing Date
- 2020-02-24
- Publication Date
- 2025-03-14
- Estimated Expiration
- 2040-02-24
Smart Images
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Abstract
Description
Title of the invention: Coupler and surgical device with a collar covering a sterile flexible envelope
[0001] The invention relates to the general field of percutaneous surgical instrumentation. It relates more particularly to percutaneous surgical instruments intended to pass through the epidermis and soft parts of the body in order to carry out, for example, samples of marrow and bone tissue for biopsy purposes.
[0002] In the field of percutaneous surgery and more particularly that of marrow biopsy and percutaneous bone biopsy, it is known to use different instruments allowing both penetration of the skin then the soft tissues then the cortex of the bone concerned and the removal of organic substances (bone marrow, bone samples) contained in the bone or in its cavity.
[0003] These instruments are generally known as bone marrow biopsy or bone biopsy needles or trocars and generally comprise a trocar or access needle, which may be combined with a biopsy cannula. Of a more or less perforating nature, the trocars or access needles allow the practitioner to pass through the soft tissues and then drill into the bone in question in order to reach a so-called sampling area.
[0004] These trocars generally comprise a hollow external tube, the end of which is more or less sharp, and inside which slides a rod called a mandrel or stylet, the end of which is sharpened so as to perforate the cortex of the bone. The bone tissue or marrow can be sampled by this rod itself or by the hollow external tube. In this case, the rod is temporarily removed from the tube and the latter is pushed or screwed forward in order to capture the sample. In another configuration, a biopsy cannula of various shapes is introduced into the tube in place of the rod and in order to carry out the marrow or bone sample.
[0005] 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 perforating rod, which the practitioner rotates so as to drill the bone. In practice, the practitioner brings the end of the external tube of the trocar into contact with the bone and then rotates the handle to make the end of the rod penetrate into the bone.
[0006] Thus, the International application published under the reference WO2006 / 061514 describes a trocar intended for bone biopsy comprising an external tube, the distal end of which is divided into two segments with a helical cutting edge, in which a rod slides sharpened. This type of instrument is intended to be used manually using a handle.
[0007] The manual implementation of such a trocar, by means of a handle directly actuated by the practitioner, corresponds to a conventional operating mode which allows the latter to finely control the gesture of perforating the bone. However, in certain circumstances, in particular when the hardness of the bone requires greater force to penetrate the needle through the wall of the bone, it is then sometimes more comfortable, both for the patient and for the practitioner, to have a training tool, of the motorized type, to penetrate the rod inside the bone without applying excessive force.
[0008] Consequently, there is a great advantage for the practitioner in having a trocar whose perforating rod can be operated either by means of a simple handle or by means of a training tool.
[0009] Such a possibility advantageously allows the practitioner to begin an operating procedure manually and then, if the hardness of the bone requires it, to complete the perforation by means of an automatic rotation drive, without it being necessary to change the perforating rod and therefore without risk of losing the entry point into the bone.
[0010] For this, an interface device capable by one of its ends of replacing the handle used by the practitioner can be used for manual implementation of the trocar; for example by mounting it 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 training tool can be fixed in a removable manner.
[0011] The device of the present invention relates to a coupling element which makes it possible to drive the trocar in rotation by means of a tool.
[0012] The objective of such a device is, among other functionalities, to be able to ensure relatively precise axial positioning of the drive tool with respect to the trocar, failing which the precision of penetration of the trocar could be affected.
[0013] Furthermore, the interface device is intended to ensure the connection of the end of a trocar, a sterile and generally single-use object, to a drill-type tool, a naturally reusable and generally non-sterile object. Therefore, it is preferable that the interface device can be associated in a simple manner with means allowing the mounting of the drive tool at the end of the trocar and the rotational driving of said trocar while avoiding any contact between the trocar and the drive tool, which could cause contamination of one by the other.
[0014] US patent 6,716,215 B1 describes a means providing a solution for connecting a sterile drill bit to a non-sterile drill through a sterile bag. The sterile bag, on which a ring is fixed, is intended to receive a drill which it allows to package it so that it can be used in a sterile environment.
[0015] In the area where the drill is connected to the bit, the seal is made by means of an O-ring, housed in the ring, which seals against the body of the bit. The seal is made by compressing the seal.
[0016] This solution, however, has the disadvantage that the bag can be driven into rotation due to the friction of the seal on the drill bit and that it can therefore, by rotating, block the drill from rotating.
[0017] US patent 7,850,620 B2 describes a system for connecting a non-sterile motorized device housed in a sterile bag to a sterile biopsy instrument by means of a coupler secured to the bag. The assembled coupler comprises a ring locked in translation but free to rotate on which the bag is welded. This solution does not allow for complete sealing because the ring can allow impurities to pass through due to its operating clearance.
[0018] Furthermore, a device such as described by US patent 7,850,620 B2 does not exclude the risk that, given the structure of the assembled coupler, the bag may be driven in rotation under the effect of friction and thus block the rotating drill by tightening around a rotating element.
[0019] The device described in US patent 7,850,620 B2 does not ensure good concentricity of the assembly during use by the practitioner due to the accumulation of functional clearances between the different assemblies. The functional clearance of the instrument mounted in the assembled coupler added to the functional clearances of the different components of the assembled coupler added to the functional clearance of the assembled coupler mounted on the motor shaft of the drive tool means that in the end the end of the instrument is unstable relative to the drive tool, which is inconvenient for the practitioner and for the precision of the surgical procedure.
[0020] Finally, the number of parts making up this device as well as their relative arrangement result in high manufacturing costs.
[0021] Patent application EP 1 771 034 A1 describes a system for connecting a non-sterile motorized drill-type device, housed in a sterile bag, to a sterile biopsy instrument by means of a coupler. The bag includes a ring whose shape allows it to match the shape of the drill's nose. A lug on the drill's nose in the form of a key and a boss on the ring allow the ring to be secured to the drill and to block any rotation of the bag around the drill. Thus, when the drill equipped with its coupler is placed in the bag, the ring and the bag are blocked in rotation by the key-shaped lug, despite the friction of the bag's seal on the body of the coupler. This solution makes it possible to both seal the bag and block its rotation.
[0022] However, the motorized device being reusable requires meticulous cleaning thereof which is difficult to achieve in the presence of key-shaped lugs or any other protuberance with more or less sharp edges. In addition, the coupling tip of the drill has machining leaving areas that are difficult to clean and the body of the drill does not cover the coupling tip, nothing excludes the possibility that impurities may be ejected under the effect of the centrifugal force generated by the rotary movement of the drill combined with the aging of the seal of the bag under the effect of friction and the heat thus released. The orientation of the fold of the seal towards the sterile surgical instrument can facilitate the ejection of impurities towards the patient during the intervention under the combined effect of the centrifugal force, the aging of the seal and the air trapped in the bag which would escape through the seal.This embodiment requires good concentricity of the opening made in the bag in relation to the ring to avoid ovalization of the fold around the body of the coupler. This precision is difficult to obtain because the bag is made with flexible materials and therefore very deformable.
[0023] There is therefore a need for a device for coupling a drive tool to a percutaneous surgical instrument which does not have the aforementioned drawbacks.
[0024] The present invention aims to provide a coupling device of simple and inexpensive design which also makes it possible to guarantee a good seal between the sterile and non-sterile elements coupled together.
[0025] The present invention also aims to ensure good concentricity and good alignment between the percutaneous surgical instrument and the drive tool so as to obtain precise positioning of the instrument.
[0026] The present invention further aims to limit the operating clearances induced by the coupling device to guarantee precise positioning of the surgical instrument and thus facilitate its use.
[0027] For this purpose, the invention relates to a coupler for the sterile coupling of a percutaneous surgical instrument to a rotational drive tool, extending along a coupling axis, said coupler comprising: - a distal portion configured to be removably connected to a percutaneous surgical instrument, - a proximal portion configured to be removably connected to a training tool, - a central portion arranged between the distal and proximal portions, the central portion comprising: °a support collar extending transversely to the coupling axis and configured to axially deform a distal end of a flexible envelope surrounding the drive tool when the proximal portion is connected to this tool training, ° a holding collar extending along the coupling axis at least partially overlapping the proximal portion so as to be able to hold the distal end of the sterile flexible envelope between the holding collar and the housing of a driving tool when the proximal portion is connected to the driving tool.
[0028] The arrangement of the support and holding collars makes it possible to form a significant obstacle to the propagation of impurities between the distal portion of the coupler to be protected from impurities and the proximal portion at which impurities can be generated, in particular from a connection tip of the drive tool.
[0029] This obstacle to the propagation of impurities is both transverse to the axis of rotation of the coupler, by means of the support collar, and longitudinal to this axis of rotation, by means of the holding collar.
[0030] In addition, the deformation of the end of the flexible envelope by the support collar makes it possible to use the end of the flexible envelope as an additional obstacle to the propagation of impurities at the proximal portion of the coupler. This further increases the difficulty of the impurities in extracting themselves from the end of the drive tool towards the distal portion of the coupler intended to be arranged at a sterile environment.
[0031] According to one embodiment of the coupler, the retaining collar extends around the coupling axis so as to form a protective bell configured to cover a connection end of a drive tool.
[0032] According to one embodiment of the coupler, the support collar extends from the central portion, the holding collar extending from one end of the support collar to form an annular space around the central portion. The support and holding collars thus form a wall curved towards the proximal portion and therefore towards the drive tool when the latter is connected to the coupler. This curved wall thus makes it possible to prevent potential impurities coming from the drive tool from being projected towards the distal portion where the sterile environment is located.
[0033] The support and holding collars thus form a protective skirt at least partially covering the proximal portion and therefore the end of the drive tool.
[0034] According to one embodiment of the coupler, the central portion further comprises a protective collar extending along the coupling axis between the holding collar and the proximal portion. An additional barrier is thus formed across the passage of potential impurities coming from the drive tool. This increases the chances of stopping the propagation of these impurities in a manner to further limit the risks of contamination of the sterile environment. The protective collar can also extend so as to at least partially cover the proximal portion. Thus, the obstacle formed by the protective collar is even more significant and forms an additional turn in the path taken by potential impurities.
[0035] According to one embodiment of the coupler, the proximal portion is a male connection configured to connect to a female connection tip of a drive tool.
[0036] The invention also relates to a sterile surgical device for driving a percutaneous surgical instrument in rotation, comprising: - a coupler according to any one of the preceding claims, - a training tool including: ° a housing and a rotating drive member arranged inside the housing, the housing defining an annular surface for receiving a flexible envelope at a connection end of the drive tool, ° a connection tip arranged at the connection end and configured to be removably connected to the proximal portion of the coupler, the connection tip being integral with the drive member so as to transmit to the coupler a rotational movement of the drive member when the proximal portion is connected to the connection tip, - a flexible envelope forming: ° a cavity for receiving a drive tool, °a first opening configured to allow the insertion of the drive tool inside the receiving cavity, ° an end portion configured to receive a connection end of the drive tool, the end portion forming a second opening opening into the receiving cavity and configured to allow partial insertion of the coupler into the receiving cavity through the second opening, ° an annular sealing portion configured to be received in contact with the annular surface of the drive tool housing when the connecting end of the drive tool is inserted into the end portion of the casing, the retaining collar of the coupler being configured to at least partially cover the annular portion of the casing when the connecting end of the drive tool is inserted into the end portion of the casing with the proximal portion of the coupler connected to the connecting tip.
[0037] According to one embodiment of the surgical device, the casing is devoid of a rigid part for connection to the drive tool or to the coupler, in the disconnected state. of the drive tool, coupler and casing.
[0038] The manufacturing cost of the casing is thus greatly reduced compared to a casing at which a ring is fixed, as described for example in US patent 7,850,620 B2. In addition, the securing of the casing with the driving tool is facilitated because the driving tool is positioned in the end portion of the casing by gravity without the need to match shapes or fixing mechanisms.
[0039] According to one embodiment of the surgical device, the annular portion of the casing and the annular surface of the housing of the drive tool are complementary in shape. Thus, the annular portion of the casing fits onto the annular surface of the housing of the drive tool to limit the propagation of impurities from the inside to the outside of the casing.
[0040] According to one embodiment of the surgical device, the annular portion of the casing has a cross-section at least partially smaller than the cross-section of the annular surface of the housing of the driving tool so as to deform the casing when the driving tool is inserted into the end portion with the annular portion and the annular surface in contact with each other.
[0041] According to one embodiment of the surgical device, the annular portion and the annular surface have a conical cross-section descending respectively towards the second opening and the connection tip. This conical conformation allows the annular surface of the drive tool to fit as closely as possible to the annular portion of the envelope.
[0042] According to one embodiment of the surgical device, the annular portion of the envelope is contiguous to the end portion.
[0043] According to one embodiment of the surgical device, the envelope is formed by at least two sheets fixed together at their end edges to form the receiving cavity, a return substantially transverse to the sheets being formed along the end edges.
[0044] According to one embodiment of the surgical device, said at least two sheets are fixed together by welding.
[0045] According to one embodiment of the surgical device, the holding collar extends so as to cover at least one third of the length of the annular portion along the coupling axis when the drive tool is connected to the coupler. This allows a good compromise between the surface covered by the holding collar and the ease of mounting the coupler. Indeed, the longer the holding collar, the more the visibility facilitating the orientation and insertion of the proximal part of the coupler into the drive tool is reduced.
[0046] According to one embodiment of the surgical device, the holding collar comprises a distal end arranged at the central portion of the coupler and a free proximal end, the holding collar and the annular surface of the drive tool being dimensioned so as to form a clearance less than or equal to 3 mm, preferably less than or equal to 2 mm, between the proximal end of the holding collar and the annular surface of the drive tool when the drive tool is connected to the coupler. The space separating the connection end of the drive tool from the holding collar is thus very small. This further prevents the spread of impurities because this space is also occupied on the one hand by the proximal end of the envelope deformed by the support collar and on the other hand by the support of the end edges of the envelope against the internal face of the holding collar. Brief description of the drawings
[0047] The attached drawings illustrate the invention:
[0048] [fig. 1] shows a sectional view of a coupler connected to a connection end of a drive tool, a flexible envelope being positioned around the drive tool between a retaining collar of the coupler and the connection end of the drive tool.
[0049] [fig.2] represents a sectional view of the coupler connected to the drive tool such that visible in [fig.l] in an angular position different from the cutting plane, thus revealing a transverse return of the envelope.
[0050] [fig.3] represents a side view of the coupler according to [fig.l] connected to the tool drive, the retaining collar and the coupler support collar being shown in section.
[0051] [fig.4] represents a perspective view of the driving tool.
[0052] [fig.5] shows a detailed view of a connection end of the tool training according to [fig.4].
[0053] [fig.6] represents a perspective view of the drive tool according to [fig.4] from a different perspective.
[0054] [fig.7] shows a detailed view of the connection end of the tool training according to [fig.6].
[0055] [fig.8] represents a side view of a sterile flexible envelope according to figures 1 to 3 into which a drive tool is to be inserted.
[0056] [fig.9] represents a perspective view of a coupler according to figures 1 to 3.
[0057] [fig. 10] represents a perspective view of the coupler according to figures 1 to 3 from a different viewing angle.
[0058] [fig.l 1] represents a perspective side view of the coupler according to figures 9 and 10, the support and holding collars as well as a coupler protection collar being shown in section. Description of embodiment(s)
[0059] The inventive concept is described more fully below with reference to the accompanying drawings, in which embodiments of the inventive concept are shown. In the drawings, the size and relative sizes of elements may be exaggerated for clarity. Like numerals refer to like elements throughout the drawings. However, this inventive concept may be embodied in many different forms and should not be construed as being limited to the embodiments set forth herein. Instead, these embodiments are provided so that this description is complete, and communicates the scope of the inventive concept to those skilled in the art.
[0060] A reference throughout the specification to "an embodiment" means that a particular feature, structure, or characteristic described in connection with an embodiment is included in at least one embodiment of the present invention. Thus, the occurrence of the phrase "in an embodiment" at various locations throughout the specification does not necessarily refer to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments. Furthermore, the term "comprising" does not exclude other elements or steps.
[0061] With reference to Figures 1 to 3, a surgical device 10 is proposed for driving a percutaneous surgical instrument (not visible) in rotation. This surgical device 10 comprises in particular a driving tool 3 and a coupler 2 for coupling the driving tool 3 to a percutaneous surgical instrument. The coupler 2 makes it possible to transmit the rotational movement generated by the driving tool to the percutaneous surgical instrument.
[0062] With reference to Figures 4 to 7, the drive tool 3 comprises a housing 36 and a rotation drive member (not visible) arranged inside this housing 36. The housing 36 comprises a connection end 31 at which the coupler 2 can be connected to the drive tool 3.
[0063] The drive tool 3 also comprises a connection end piece 32 arranged at the connection end 31. The connection end piece 32 is configured to be removably connected to the coupler 2. The connection end piece 32 is furthermore integral with the drive member so as to be able to transmit to the coupler 2 a rotational movement of the drive member.
[0064] Preferably, the connection tip 32 does not extend outside the housing 36 so as to limit the spaces in which impurities could lodge. in other words, the connection tip 32 preferably does not come out of the connection end 31 of the housing 36. Preferably, the connection tip 32 is set back from the distal end of the housing 36. This results in the fact that the connection tip 32 is completely covered by the housing 36 when it is observed in side view as visible in FIGS. 1 and 2. This makes it possible to cover all the rotating parts of the drive tool 3 and to avoid any projection of particles located on the connection tip 32 during the rotation thereof.
[0065] The drive member 3 comprises in particular a motor coupled to a transmission member itself coupled to the connection end piece 32. The transmission member is preferably a reduction member making it possible to reduce the rotational speed transmitted by the motor while increasing the torque transmitted to the connection end piece 32. Alternatively, the drive tool 3 may be devoid of a reduction member so that the transmission member only makes it possible to transmit the rotational movement of the motor to the connection end piece 32 without modifying the rotational speed or the torque. The motor is for example an electric motor. The drive member may therefore integrate inside the housing 36 a battery and / or a connection port to a power supply. The battery may be rechargeable.
[0066] According to the exemplary embodiment shown in Figures 4-7, the connection end piece 32 is in the form of a cavity 321 comprising an internal wall which has a rear zone 323 of hexagonal shape and a front end 322 of truncated cone shape. A chamfered groove 324 is made in the internal wall of the cavity 321 at the level of the hexagonal rear zone 323.
[0067] In this example, the connection end piece 32 also comprises a blind cylindrical bore 325 forming the bottom of the end piece, the axis of symmetry of which coincides with the general axis of symmetry of the coupling end piece 32.
[0068] The surgical device 10 further comprises a sterile flexible envelope 1 intended to at least partially cover the drive tool 3 to isolate it from the sterile environment. The flexible envelope 1 forms a cavity for receiving the drive tool 3. “Flexible” means that the envelope 1 is capable of elastically deforming under the action of a user to form an interior volume allowing the insertion of the drive tool 3 inside the envelope 1. The flexibility of the envelope 1 is notably defined by the thickness of the walls which form it as well as by its material.
[0069] The envelope 1 is preferably formed by at least two sheets fixed together at their end edges to form the receiving cavity. These sheets are for example fixed together by welding. A return or border 16 is formed along the end edges, with a width less than or equal to 5 mm. This return 16 corresponds to a free strip formed between the end edge of the sheets and the area where the sheets have been fixed together, for example by welding. This return 16 is notably visible in figures 2, 3 and 8. This return 16 extends substantially transversely to the walls of the envelope 1 forming the receiving cavity when an object is inserted inside this receiving cavity, notably the driving tool 3. The envelope 1 is preferably made of plastic material compatible with the surgical environment.
[0070] The sheets forming the envelope 1 are for example of a thickness less than 1 mm, preferably less than 0.5 mm, more preferably equal to 0.15 mm.
[0071] The flexible envelope 1 is devoid of a rigid connection part to the drive tool 3 or to the coupler 2. Therefore, when the envelope 1 is not mounted on the drive tool 3 or is not in proximity to the coupler 2, for example when the surgical device 10 is arranged on a packaging tray, no rigid connection part is fixed to the envelope 1. In other words, in the disconnected or disassembled state of the surgical device 10, the envelope 1 does not comprise any rigid connection part. This disconnected or disassembled state of the surgical device 10 corresponds to a state in which the envelope 1, the coupler 2 and the drive tool 3 are dissociated from each other, i.e. without being fixed to each other.
[0072] A first opening 13 is formed by the flexible casing 1. This first opening 13 is configured to allow the insertion of the drive tool 3 inside the receiving cavity. The first opening 13 is sized so as to allow easy insertion of the drive tool 3 inside the casing 1. The first opening 13 is provided with two folds 17 to facilitate handling and closing means 18 (adhesive for example) allowing the first opening 13 to be closed tightly.
[0073] The flexible casing 1 also forms an end portion 15 configured to receive the connection end 31 of the driving tool 3. In other words, the flexible casing 1 comprises a narrowing into which the nose of the driving tool 3 can be inserted. A driving tool, for example of the drill type, is usually formed of a first portion forming a handle and a second portion to which a part is coupled to be driven in rotation. Preferably, the nose of the driving tool 3 corresponds to this second portion so that the connection end 31 is arranged at the nose of the driving tool 3.
[0074] A second opening 12 is formed at the end portion and opens into the interior of the receiving cavity of the flexible envelope 1. This second opening 12 is in particular formed at a distal end of the casing 1. This second opening 12 is configured to allow the partial insertion of the coupler 2 inside the receiving cavity through the second opening 12. Preferably, the partial insertion of the coupler 2 corresponds to the insertion of a proximal connection portion of the coupler to the driving tool. Thus, the coupler 2 is connected to the driving tool through the second opening 12 of the flexible casing 1.
[0075] This second opening 12 is preferably formed opposite the first opening 13 relative to the receiving cavity so as to facilitate the positioning of the driving tool 3 in the connection end 15. Indeed, the driving tool 3 is preferably inserted inside the receiving cavity with its connection end forward and then released inside the flexible envelope 1 to position itself under the effect of gravity without contact of the user with the driving tool 3 to avoid any contamination. It is thus made easier to carry out this maneuver of positioning the driving tool 3 if the first 13 and second 12 openings are arranged opposite one another.
[0076] The flexible envelope 1 further forms an annular sealing portion 14 arranged in the vicinity of the end portion 15, between the first 13 and second 12 openings. Preferably, the annular portion 14 is contiguous to the end portion 15.
[0077] With reference to figures 1 and 2, the annular portion 14 is configured to be received in contact with the housing 36 of the drive tool 3 when the latter is engaged in the end portion 15. In particular, the annular portion 14 is configured to be placed in contact with an annular surface 33 of the housing 36 when the latter is engaged in the end portion 15.
[0078] This contact surface between the housing 36 and the flexible envelope 1 makes it possible to prevent the propagation of impurities coming from the interior of the envelope towards the second opening 12. The annular portion 14 is preferably fitted on the annular surface so as to increase the contact surface and thus reduce the possibility of propagation of the impurities.
[0079] The annular portion 14 of the casing 1 and the annular surface 33 of the housing 36 are preferably complementary in shape so as to further improve the contact surface. More preferably, the annular portion 14 of the casing 1 has a cross-section at least partially smaller than the cross-section of the annular surface 33 of the housing 36. Thus, the annular portion 14 deforms in contact with the annular surface 33 when the driving tool is inserted into the end portion 15. This deformation allows a tight fit between the annular portion 14 and the annular surface 33, thus improving the capacity of the casing 1 to block impurities.
[0080] In addition, the annular portion 14 and the annular surface 33 preferably have a conical cross-section, as seen in FIGS. 1, 2 and 8. These conical cross-sections are oriented such that they descend respectively towards the second opening 12 and the connection end piece 32. By "descend" is meant the fact that the dimension of the cross-section decreases towards the second opening 12 and the connection end piece 32, respectively.
[0081] This conical conformation allows axial and longitudinal positioning of the drive tool 3 inside the casing 1.
[0082] With reference to Figures 1 to 3 and 9 to 11, the coupler 2 has the function of allowing the coupling of a percutaneous surgical instrument to the drive tool 3 so as to rotate this instrument. The distal portion 27 thus forms a mechanical interface between the coupler 2 and the end of a surgical instrument.
[0083] The coupler 2 is preferably an elongated element having a symmetry of revolution around its longitudinal axis A.
[0084] The coupler 2 comprises a distal portion 27 configured to be removably connected to a percutaneous surgical instrument.
[0085] The distal portion 27 comprises a cylindrical body 221, of circular external section, defining an internal cavity forming a receiving cavity 223 intended to receive the end of the percutaneous surgical instrument to which the drive tool 3 is to be coupled.
[0086] According to the illustrated embodiment, the distal portion 27 is intended to be placed outside the casing 1 when the coupler 2 is connected to the driving tool 3 with the casing 1 positioned on the driving tool 3. The length of the distal portion 27 is mainly defined in such a way that, when the coupler 2 is put in place, a free end 225 of the distal portion 27 is located outside the casing 1.
[0087] In the embodiment taken as an example, the receiving cavity 223 is a cavity of hexagonal section on the walls of which are provided, at the end 225, openings 224 allowing the fitting of fixing lugs placed at the end of the percutaneous surgical instrument. The end tip of the percutaneous surgical instrument can then, for example, take the form of a cylinder with a hexagonal base, intended to be housed in a cylindrical cavity with hexagonal walls, provided in a given rotation means.
[0088] The length of the end tip of the instrument, the depth of the cavity, as well as the general dimensions of the distal portion 27 and of the receiving cavity 223 are mainly defined in such a way that the assembly is assembled with a minimum of play, so that the implementation by the practitioner of said tool with a rotating tip causes a rotation of the instrument on itself around its axis of symmetry and a penetration of the instrument in a substantially rectilinear direction.
[0089] The coupler 2 also comprises a proximal portion 28 configured to be removably connected to the drive tool 3. In particular, the proximal portion 28 is configured to be removably connected to the connection tip 32. The proximal portion 28 thus forms a mechanical interface between the coupler 2 and the drive tool 3. The proximal portion 28 is intended to be housed at least partially inside the casing 1 when it is connected to the drive tool 3.
[0090] The proximal portion 28 is preferably a male connection configured to connect to the female connection tip 32 of the drive tool 3.
[0091] In the embodiment considered, an external wall of the proximal portion 28 forms a male element of hexagonal section. In this case, the connection end piece 32 is also of hexagonal section so as to be able to insert the proximal portion 28 inside the connection end piece 32.
[0092] The proximal portion 28 may also comprise a frustoconical zone 215 configured to cooperate with a frustoconical shape 322 of the connection end piece 32. The interlocking of the frustoconical zone 215 with the frustoconical shape 322 of the connection end piece 32 makes it possible to ensure that the concentricity of the coupler 2 and the connection end piece 32 is maintained without play during use. The frustoconical zone 215 and shape 322 also have the function of providing a translational stop for the coupler 2 in the connection end piece 32.
[0093] The proximal portion 28 may also comprise a member for fixing the coupler 2 to the connection end piece 32. With reference to FIGS. 5, 7, 10 and 11, the fixing member may comprise a cylindrical end element 23, split along its length and intended to be inserted into a blind cylindrical bore 325 forming the bottom of the connection end piece 32 of the drive tool 3.
[0094] The end element 23 preferably comprises a plurality of bosses 232 forming excess thicknesses such that the diameter of the section of the end element 23 is locally greater than the diameter of the bore 325. The presence of a slot 231 makes it possible to make the end element 23 deformable in such a way that when the coupler 2 is coupled to the connection end piece 32 of the drive tool 3, the bosses 232 rub against the wall of the bore 325, which advantageously makes it possible to prevent the coupler 2 from moving freely in the connection end piece 32.
[0095] The fixing member may also comprise at the level of the external wall of the proximal portion 28 a plurality of chamfered bosses 212 shaped to be able to be housed in a chamfered groove 324 made in an internal wall of the cavity 321 of the connection end piece 32. It is thus possible to ensure the locking of the coupler 2 by snap-fastening the proximal portion 28 into the connection end piece 32.
[0096] Furthermore, the proximal portion 28 can define an internal cavity extending the cavity 223 of the distal portion 27 in such a way that the tip of the percutaneous surgical instrument can be housed completely in the coupler 2. This cavity 223 is closed on the side of the end of the proximal portion 28.
[0097] The coupler 2 further comprises a central portion 29 arranged between the distal 27 and proximal 28 portions. The central portion 29 forms a section of the coupler 2 arranged between the distal 27 and proximal 28 portions. This section may be circular cylindrical and, for example, annular.
[0098] The central portion 29 comprises a support collar 240 extending from the section formed by the central portion 29. The support collar 240 extends transversely to the coupling axis A. In other words, the support collar 240 extends substantially radially to the coupling axis A. The support collar 240 forms a preferably circular wall extending around the section of the central portion 29.
[0099] The support collar 240 is configured to axially deform the distal end of the flexible envelope 1 surrounding the drive tool 3 when the proximal portion is connected to this drive tool 3. In other words, the support collar 240 is configured to come to bear against the distal end of the end portion 15 of the envelope 1 to deform it and form an annular fold providing a seal when the coupler is mounted in the drive tool 3.
[0100] For this, the support collar 240 is shaped so that its maximum external dimension, i.e. its external diameter when its section is circular, is greater than the section of the proximal portion 28. In other words, the support collar 240 thus forms a disc or a flange extending radially beyond the proximal portion 28. In particular, this maximum external dimension, or external diameter, is equal to or greater than the maximum external dimension, or external diameter, of the connection end 31 of the drive tool 3.
[0101] Furthermore, the flexible envelope 1 is shaped in such a way that a portion of the envelope 1 forming the second opening 12 extends beyond the connection end piece 32 when the annular portion 14 of the envelope 1 is in contact with the annular surface 33 of the drive tool 3. This portion of the envelope 1 is made in such a way that its length is greater than the distance taken along the coupling axis A separating the distal end of the connection end piece 32 from the coupler 2. Thus, this portion of the envelope 1 comes into contact with the support collar 240 and then deforms when the coupler 2 is coupled to the drive tool when the latter is inserted into the envelope 1. This deformed portion of the envelope thus provides a barrier for potential impurities coming from inside the drive tool 3. Indeed, the impurities have that a very narrow and tortuous passage to exit the envelope through the second opening 12.
[0102] The effect of this deformation of the end of the ballast casing is particularly visible in section in figures 1 and 2 and in side view in [fig.3].
[0103] Furthermore, when the drive tool 3 is housed in the casing 1 and the coupler 2 is mounted in the connection end piece 32, the returns 16 located at the annular 14 and end 15 portions deform and come into contact with the internal surface of the retaining collar 243 (see [fig.2]). This makes it possible, during rotation of the coupler 2, to retain all the particles which could have escaped from the seal formed by the deformation of the end of the end portion 15 against the support collar 240.
[0104] The central portion 29 also comprises a holding collar 243 extending along the coupling axis A. The holding collar 243 forms an annular wall extending along the coupling axis A. The holding collar 243 preferably extends from one end of the support collar 240 so that the support collar 240 and holding collar 243 are contiguous. The holding collar 243 extends around the coupling axis A so as to form a protective bell 24 configured to cover the connection end 33 of the driving tool 3. Thus, the dimension of the holding collar 243 along the coupling axis A is defined so that the holding collar 243 covers this connection end 33.For this, the holding collar 243 at least partially covers the proximal portion 28 so as to be able to hold the distal end of the sterile flexible envelope between the holding collar 243 and the housing 36 of the driving tool 3 when the proximal portion 28 is connected to the driving tool 3.
[0105] The holding collar 243 preferably extends so as to cover at least one third of the length of the annular portion 14 of the casing 1, along the coupling axis A, when the drive tool 3 is connected to the coupler 2. More preferably, the holding collar 243 preferably extends so as to cover substantially half of the length of this annular portion 14 in the connected state of the drive tool 3 and the coupler 2.
[0106] The holding collar 243 is made such that its internal transverse dimension, or internal diameter when it is of circular section, is greater than the external diameter of the connection end portion 31 which it covers. Thus, the internal dimension of the holding collar 243 allows it to be inserted around the connection end 31 of the drive tool 3.
[0107] In addition, the end portion 15 of the casing 1 preferably has a maximum external dimension less than the internal dimension of the retaining collar 243 to facilitate the insertion of the casing 1 into the retaining collar 243.
[0108] The retaining collar 243 comprises a distal end disposed at the level of the support collar 240 and a free proximal end. The holding collar is preferably shaped so that the free proximal end is arranged close to the housing 36 when the coupler 2 is connected to the drive tool 3. Thus, the possibilities of impurities propagating outside the annular space 244 formed by the holding collar 243 are reduced. According to an exemplary embodiment, the holding collar 243 and the annular surface 33 of the drive tool 3 are dimensioned so as to form a clearance less than or equal to 3 mm, preferably less than or equal to 2 mm, between the free proximal end of the holding collar 243 and the annular surface 33 of the drive tool 3 when the drive tool 3 is connected to the coupler 2.
[0109] As visible in figures 1 and 2, an annular space 244 is thus formed by the holding collar 243 around the proximal portion 28. The distal end of the driving tool 3 is thus confined inside this annular space 244 when it is connected to the coupler 2. This makes it possible to channel potential impurities coming from the inside of the casing 1 or the driving tool 3 into this annular space 244. The annular space is closed at a first end by the support collar 240 and open at a second opposite end.
[0110] The central portion 29 further comprises a protective collar 242 extending along the coupling axis A between the holding collar 243 and the proximal portion 28. In other words, the protective collar 242 extends inside the annular space 244 formed by the holding collar 243. The protective collar 242 preferably extends from the support collar 240.
[0111] This protective collar 242 is configured to at least partially cover the connection end 31 of the drive tool 3 when the coupler 2 is coupled to the drive tool 3. In other words, the protective collar 242 is configured to cover a portion of the housing 36 arranged at its connection end.
[0112] This conformation of the protective collar 242 makes it possible to add an obstacle for impurities coming from inside the drive tool 3. Indeed, the passage for these impurities is thus made more tortuous and makes it possible to reduce the risks of these impurities escaping through the directory space.
[0113] In addition, the longitudinal extension of the protective collar 242 forms a retention space 245 for the impurities between the protective collar 242 and the proximal portion 28. In fact, the potential impurities leaving the driving tool 3 are projected inside this retention space 245 under the effect of the centrifugal force generated by the rotation of the connection end piece 32.
[0114] The protective collar 242 is preferably of conical section descending towards the proximal portion 28. In other words, the transverse dimension of the collar protective collar 242 decreases from its proximal end fixed to the support collar 240 towards its free distal end. Thus, the retention of impurities is further improved.
[0115] According to one embodiment, the internal diameter of the protective collar 242 is greater than the external diameter of the connection end 34 of the housing 36 so as not to generate friction when the coupler 2 is rotated.
[0116] The assembly formed by the support 240 and holding 243 collars may be a part added to the central portion 29 of the coupler 2 or else in one piece with this central portion 29. The protective collar 242 is preferably formed in one piece with the support collar 240. Thus, the protective collar 240 is part of this assembly formed by the support 240 and holding 243 collars.
[0117] Preferably, the second opening 12 and the end portion 15 have a diameter less than the minimum internal diameter of the holding collar 243 but greater than the maximum external diameter of the protective collar 242. This is to avoid any risk of blocking the rotation of the coupler 2 by tightening the end portion 15 around the protective collar 242 due to friction of the distal end of the end portion 15 on the support collar 240.
[0118] As the preceding description tends to show, the structure of the coupler 2 and of the surgical device 10 according to the invention thus advantageously makes it possible, in particular in the preferred embodiment taken as an example, to guarantee a seal between the receiving cavity of the envelope 1 capable of containing non-sterile material (the drive tool 3 in particular) and the rest of the space in which the device is implemented, a space which is sterile in principle.
[0119] Taking into account the technical characteristics of the coupler 2 and the surgical device 10 according to the invention, it is thus advantageously possible to carry out in a simple manner the removable coupling of a drive tool 3, a non-sterile tool, to a sterile biopsy instrument, without risking involuntarily contaminating the sterile environment during the coupling operation or the reverse separation operation.
[0120] It should be considered here that, given the close relationship existing between the structures of the respective ends of the coupler 2 and the connection tip 32 of the drive tool 3, intended to cooperate to ensure the connection of these two elements, the invention aims to allow the removable coupling of a drive tool 3, a non-sterile tool, to a necessarily sterile biopsy instrument by guaranteeing the confinement of the drive tool 3, but also to ensure in an optimal manner the rotation of the biopsy instrument by the drive tool 3. By optimal manner is meant here a manner making it possible in particular to limit the clearances which may exist at the level of the different interfaces forming the mechanical chain connecting the drive tool 3 and the biopsy instrument.
[0121] From an operational point of view, the operation of sterile coupling of a biopsy instrument and a drive tool of said instrument by means of the surgical device 10 according to the invention can be described by the following implementation steps: - a first step during which the practitioner, equipped with sterile gloves, grasps the envelope 1 by the folds 17, opens it and presents it to the assistant who inserts the connection end 31 of the driving tool 3 into the end portion 15 of the envelope 1 and releases the driving tool 3, the latter then being held and retained by the practitioner by means of the envelope 1; - a second step during which the practitioner hermetically closes the first opening 13 of the envelope 1 using closing means 18 arranged at the level of said first opening 13 without touching the driving tool 3, so that it encloses the driving tool 3; - a third step during which the practitioner assembles the connection tip 32 of the drive tool 3 on the proximal portion 28 of the coupler 2 until the two elements fit together; the end portion 15 is thus deformed by the support collar 240 inside the annular space 244 formed by the holding collar 243; - a fourth step during which the practitioner places the percutaneous surgical instrument by inserting it into the distal portion 27 of the coupler 2.
Claims
Claims
1. Coupler (2) for the sterile coupling of a percutaneous surgical instrument to a rotating drive tool (3), extending along a coupling axis (A), said coupler (2) comprising: - a distal portion (27) configured to be removably connected to a percutaneous surgical instrument, - a proximal portion (28) configured to be removably connected to a drive tool (3), - a central portion (29) arranged between the distal (27) and proximal (28) portions, the central portion (29) forming a section of the coupler (2) arranged between the distal (27) and proximal (28) portions, the central portion (29) comprising: °a support collar (240) extending transversely to the coupling axis (A) and configured to axially deform a distal end of a flexible envelope (1) surrounding the tool drive (3) when the proximal portion (28) is connected to this drive tool (3),° a holding collar (243) extending along the coupling axis (A) at least partially overlapping the proximal portion (28) so as to be able to hold the distal end of the sterile flexible envelope (1) between the holding collar (243) and the housing (36) of a driving tool (3) when the proximal portion (28) is connected to the driving tool (3).,
2. Coupler (2) according to claim 1, wherein the retaining collar (243) extends around the coupling axis (A) so as to form a protective bell (24) configured to cover a connection end (31) of a drive tool (3).
3. A coupler (2) according to claim 1 or 2, wherein the support collar (240) extends from the central portion (29), the retaining collar (243) extending from one end of the support collar (240) to form an annular space (244) around the proximal portion (28).
4. Coupler (2) according to any one of claims 1 to 3, wherein the central portion (29) further comprises a protective collar (242) extending along the coupling axis (A) between the retaining collar (243) and the proximal portion (29).
5. Coupler (2) according to any one of claims 1 to 4, in wherein the proximal portion (28) is a male connection configured to connect to a female connection tip (32) of a driving tool (3).
6. Sterile surgical device (10) for driving a percutaneous surgical instrument in rotation, comprising: - a coupler (2) according to any one of the preceding claims, - a drive tool (3) comprising: ° a housing (36) and a rotation drive member arranged inside the housing (36), the housing (36) defining an annular surface (33) for receiving a flexible envelope (1) at a connection end (31) of the drive tool (3), ° a connection tip (32) arranged at the connection end (31) and configured to be removably connected to the proximal portion (28) of the coupler (2), the connection tip (32) being integral with the drive member so as to transmit to the coupler (2) a rotational movement of the drive member when the proximal portion (28) is connected to the connection tip (32),- a flexible casing (1) forming: ° a cavity for receiving a drive tool (3), ° a first opening (13) configured to allow the insertion of the drive tool (3) inside the receiving cavity, ° an end portion (15) configured to receive a connection end (31) of the drive tool (3), the end portion (15) forming a second opening (12) opening inside the receiving cavity and configured to allow the partial insertion of the coupler (2) inside the receiving cavity through the second opening (12), ° an annular sealing portion (14) configured to be received in contact with the annular surface (33) of the housing of the drive tool (3) when the connection end (31) of the drive tool (3) is inserted into the end portion (15) of the casing (1),the retaining collar (243) of the coupler being configured to at least partially cover the annular portion (14) of the casing (1) when the connecting end of the driving tool is inserted into the end portion (15) of the casing (1) with the proximal portion of the coupler connected to, the connection tip (32).
7. Surgical device (10) according to claim 6, wherein the casing (1) is devoid of a rigid part for connection to the driving tool (3) or to the coupler (2), in the disconnected state of the driving tool (3), the coupler (2) and the casing (1).
8. Surgical device (10) according to claim 6 or 7, wherein the annular portion (14) of the casing (1) and the annular surface (33) of the housing (36) of the driving tool (3) are complementary in shape.
9. A surgical device (10) according to claim 6 to 8, wherein the annular portion (14) of the casing (1) has a cross-section at least partially smaller than the cross-section of the annular surface (33) of the housing (36) of the driving tool (3) so as to deform the casing (1) when the driving tool (3) is inserted into the end portion (15) with the annular portion (14) and the annular surface (33) in contact with each other.
10. A surgical device (10) according to claim 8 or 9, wherein the annular portion (14) and the annular surface (33) have a conical cross-section descending respectively towards the second opening (12) and the connecting tip (32).
11. A surgical device (10) according to any one of claims 6 to 10, wherein the annular portion (14) of the casing (1) is contiguous with the end portion (15).
12. Surgical device (10) according to any one of claims 6 to 11, wherein the envelope (1) is formed by at least two sheets fixed together at their end edges to form the receiving cavity, a return (16) substantially transverse to the sheets being formed along the end edges when the drive tool (3) is housed in said envelope (1).
13. The surgical device (10) of claim 12, wherein said at least two sheets are secured together by welding.
14. A surgical device (10) according to any one of claims 6 to 13, wherein the retaining collar (243) extends so as to cover at least one third of the length of the annular portion (14) along the coupling axis (A) when the drive tool (3) is connected to the coupler (2).
15. A surgical device (10) according to any one of claims 6 to 14, wherein the retaining collar (243) comprises an end distal end disposed at the central portion (29) of the coupler (2) and a free proximal end, the holding collar (243) and the annular surface (33) of the driving tool (3) being sized so as to form a clearance less than or equal to 3mm, preferably less than or equal to 2mm, between the proximal end of the holding collar (243) and the annular surface (33) of the driving tool (3) when the driving tool (3) is connected to the coupler (2).