• 专利附录
  • 专利说明
  • 权利要求
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    • 专利摘要:
    HANDLING UNIT WITH FORCED IMPLANT SEQUENCE AND INDEPENDENT ACTIVATION MECHANISM. It is a handling unit for use in the implantation of a medical device through several implant lines that pass through a catheter. The handling unit includes several removable members for the implantation or activation of the medical device. The manipulation unit also includes a drive mechanism to move a wire through the catheter to drive the medical device independently of the various removable members.
    公开号:BR112013002640B1
    申请号:R112013002640-5
    申请日:2011-08-16
    公开日:2021-02-17
    发明作者:Justin W. Sokel
    申请人:Gore Enterprise Holdings, Inc.；
    IPC主号:
    专利说明:

    [0001] [001] The present application claims the benefit of the United States provisional patent application serial number 61 / 374,560, filed on August 17, 2010, the contents of which are incorporated into this document by reference in full for all purposes. . BACKGROUND OF THE INVENTION FIELD OF THE INVENTION
    [0002] [002] The present invention relates to a tool with a sequence of fixed activation steps. More specifically, it refers to manipulators for implanting medical devices that aim to eliminate errors on the part of the physician following the implantation of the said medical devices. DISCUSSION OF THE STATE OF THE TECHNIQUE
    [0003] [003] In the art, there is knowledge of endovascular medical devices that require a specific order of steps to complete an implant. For example, the vascular prosthesis disclosed in United States patent 5,554,183, in the name of Nazari, has several control lines that need to be activated in a specific sequence in order to correctly expand the device. Nazari, however, does not reveal a tool or operational manipulator that protects the expansion sequence from failure. Similar medical devices, which also require a specific manipulation sequence of the control lines in order to ensure correct expansion, are disclosed in WO 97/48350, in the name of Lauterjung, and in the United States patent 5,776,186, in the name of Uflacker. None of the documents mentioned reveals a tool or operational manipulator that requires the correct sequence of manipulation of the traction lines.
    [0004] [004] There is knowledge of various instruments, tools, manipulators, etc. medical devices to implant endovascular devices. Examples of these implant tools are used in orientable catheter systems, in which one or more lines of traction act as tendons. When pulled, the traction line deflects part of the catheter (usually the most distal end). Bypassing the catheter allows you to move it accurately through complex vasculatures. Other manipulators for the implantation of medical devices provide mechanical advantage to the traction of a rope line or containment sheath, used in self-expanding intravascular devices such as stent grafts. See, for example, United States patent application 2005/0080476, in the name of Gunderson et al., To find out about a manipulator that provides a mechanical traction advantage. Other embodiments of tools used to implant medical devices include simple luer-lock connectors with traction lines connected to luer members. When removing a member from the luer connector, the traction line is activated. See, for example, United States patent application 2002/0151953, in the name of Chobotov et al. As usual in the technique, in the unit composed of the luer-lock connector and the luer member, revealed by Chobotov et al., They are not interconnected; that is, the various activation strings / rods can be activated in any order. In these non-interconnected systems, it is common to use training, visual aids and markings to induce the correct administration sequence. Despite major initiatives to ensure the correct sequence of steps, physicians still involuntarily make mistakes. SUMMARY OF THE INVENTION
    [0005] [005] The present invention proposes an interconnected control manipulator that requires a predetermined sequence of activations. Control manipulators according to the present invention are suitable for use in the implantation of medical devices.
    [0006] [006] In accordance with one aspect of the invention, a handling unit for use in implanting a medical device is provided by means of several implant lines passing through a catheter. The handling unit includes several removable members, each connected to at least one of the several lines, in which each of the several lines is operationally coupled to the medical device for implantation or selective activation thereof. The various removable members interconnect in series in a removable way so that only one of them presents itself for manipulation by the user and so that the removal of each one introduces another one of them for manipulation by the user. The manipulation unit further includes a drive mechanism for displacing a wire that passes through the catheter in order to drive the medical device independently of the various removable members.
    [0007] [007] In accordance with another aspect of the invention, a handling unit is provided for use in the implantation of a medical device by means of several implant lines that pass through a catheter. The manipulation unit includes a drive mechanism for displacing a thread that passes through the catheter in order to manipulate the medical device independently of the various implant lines. More specifically, the drive mechanism includes a threaded rod that extends along a longitudinal axis. A nut is threaded onto the rod and attached to one end of the wire in such a way that the nut and the wire travel together widely along the longitudinal axis in response to the selective rotation of the rod around the longitudinal axis. The handling unit also includes a tube that extends through the rod and is rotatably coupled to it in order to rotate it around the longitudinal axis. The tube also includes a widely continuous orifice in relation to at least one channel in the catheter to allow guiding a guidewire through the catheter and through the handling unit.
    [0008] [008] In accordance with yet another aspect of the invention, a handling unit is provided for use in the implantation of a medical device by means of several implant lines that pass through a catheter, wherein the handling unit includes a drive mechanism to displace a wire passing through the catheter to manipulate the medical device independently of the various implant lines. The drive mechanism includes a threaded rod, a thread and a tube. The threaded rod extends along a longitudinal axis. The nut is screwed onto the rod and attached to one end of the wire in such a way that the nut and the wire travel together widely along the longitudinal axis in response to the selective rotation of the rod around the longitudinal axis. The tube has an external support surface, which rotatively supports the threaded rod so that it rotates around the longitudinal axis, and an internal surface, which defines a widely continuous orifice in relation to a channel in the catheter to allow a guidewire passes through the catheter and the handling unit leaving the handling unit.
    [0009] [009] Other characteristics and advantages of the present invention will be established in the description below, which can also be learned by the practice of the present invention. These other characteristics and advantages of the present invention are obtained and realized by the structure particularly revealed in the description and in the claims of this document, as well as illustrated in the attached drawings.
    [0010] [010] It should be kept in mind that both the general description above and the detailed description below are exemplary and explanatory, therefore serving to better explain the invention as claimed.
    [0011] [011] The accompanying drawings, which are attached and are part of the present specification, were illustrated to facilitate the understanding of the present invention, represent embodiments of the present invention and serve to explain its principles together with this specification.
    [0012] [012] In the drawings:
    [0013] [013] Figures 1A and 1B are seen in perspective of a handling unit and a medical device according to an embodiment of the present invention.
    [0014] [014] Figures 2A and 2B are seen in perspective of the handling unit and the medical device during the first implantation phase.
    [0015] [015] Figures 3A and 3B are a perspective view of the handling unit and a partial side view of the distal part of the medical device, which illustrates the manipulation of the position of the medical device and the retraction and release of the device's anchors.
    [0016] [016] Figure 4 is a partial perspective view of the distal part of the self-expanding medical device, which illustrates details of the second control line.
    [0017] [017] Figures 5A and 5B are seen in section and in perspective of a handling unit, which illustrate the fixed traction sequence of the second and third control lines.
    [0018] [018] Figures 6A and 6B are a perspective view of the handling unit and a side view of the medical device, which illustrate the removal of the second and third control lines.
    [0019] [019] Figures 7A and 7B are seen in perspective of the handling unit and the medical device, which illustrate the activation of the fourth control line.
    [0020] [020] Figure 8 is a perspective view of the handling unit that illustrates a security access door.
    [0021] [021] Figures 9A to 9F are partial top and side views in cross section of a device and method used to connect a control line to a substrate or connection mechanism.
    [0022] [022] Figures 10A to 10D illustrate top, perspective and cross-sectional views of a test apparatus used to evaluate the retention mechanism of the present invention.
    [0023] [023] Figure 11 is a cross-sectional view of a handling unit according to an alternative embodiment of the present invention.
    [0024] [024] Figure 12 is an enlarged cross-sectional view of the drive mechanism of the handling unit of figure 11.
    [0025] [025] Figure 13 is a perspective view of the handling unit in Figure 11 with cuts showing its interior.
    [0026] [026] The present invention relates to a manipulator used to implant a medical device, in which the manipulator helps the physician to perform a fixed sequence of activation steps. In its simplest form, the manipulator comprises a first removable member, connected to a first line that extends distally to communicate with a remote expandable device, and a second member, which has an adjustment mechanism to regulate the expandable device. The second member is covered, at least in part, by the first removable member and connects to a second line that extends distally to communicate with the remote expandable device.
    [0027] [027] Another aspect of the present invention relates to a manipulator comprising a first removable member, connected to a first line that extends distally to communicate with a remote expandable device; a second removable member, having a rotating part, the second member being covered, at least in part, by said first removable member and connected to a second line extending distally to communicate with the remote expandable device; and a third member covered, at least in part, by said second removable member and connected to a third line extending distally to communicate with the remote expandable device.
    [0028] [028] Members can take the form of removable and / or mobile members. Examples include, but are not limited to, a wire, a liner, a button, a button unit (that is, a button with components inside it), a pin, a cover, a cover, a strip (for example, a ribbon), a hook, a key or other structures that induce the sequence of removal and / or activation of the distally extending lines. Said first, second, third or other additional members may be a combination of any of the types of members listed above or any other structures. Said members connect to lines that extend distally. The members can be removed and / or moved, among others, by rotation, traction, propulsion, pressure, deflection, untying, breaking or any other method to remove and / or move a member and still be able to activate a line that extends distally. In one aspect, said members can cover each other (that is, lodge other members within themselves). In another aspect, said members prevent a member from being removed and / or moved before another member is removed and / or moved. The manipulator with fixed activation sequence can also comprise a door that allows access to at least one of the first, second, third or other additional lines that extend distally.
    [0029] [029] In another aspect, the manipulator with fixed activation sequence has at least one first, second and third removable members, each connected to a line that extends distally to communicate with a remote expandable device with first and second parts ; wherein removing the first member from the manipulator results in partial expansion of the first part of the remote expandable device and gives access to the second member. The second member can include a rotating part, where the rotation of said rotating part regulates the first part of the expandable device and where the removal of said second member results in the full expansion of the first part of the device and gives access to the third member. The manipulation of the third member expands the second part of the device. In another aspect, the presence of the first limb prevents the removal and / or movement of the second. In another aspect, the presence of the second member prevents the removal or movement of the third. In yet another aspect, the third member is disposed within the second and the second within the first. In another aspect, said removable members can be tied together to facilitate the counting of the removed components by the medical / implant team. In yet another aspect, there is also a system for positioning each removed component on a support so that it can be easily counted.
    [0030] [030] Also proposed is a method for implanting an expandable device, which comprises the steps of: providing a manipulator with at least one first, second and third removable members, each connected to at least one line extending distally to communicate with a remote expandable device with first and second parts; implant the expandable device in the desired location; removing the first member of the manipulator in order to partially expand the first part of the device and give access to the second member; rotating a rotating part of the second member to adjust the first part of the expandable device; remove the second member in order to complete the expansion of the first part of the device and give access to the third member; and manipulating the third member in order to expand the second part of the device, resulting in the implantation of the expanded device.
    [0031] [031] For explanatory purposes, Figures 1 to 7 illustrate detailed examples of a medical device and an implant sequence. Sequential steps are imposed and forced by the design of the implant manipulator. For the sake of clarity, figures 1 to 7 illustrate the various phases of activation of the manipulator together with the corresponding view of a typical medical device as it expands.
    [0032] [032] Figures 1A and 1B are seen in perspective of a handling unit according to an embodiment of the present invention. Figure 1B illustrates a side view of the medical device to be expanded. Figure 1A illustrates a handling unit 100 with catheter 102. Catheter 102 extends to a medical device 104. In the illustration, part of the catheter has been omitted in order to display the internal control lines. The medical device illustrated is a self-expanding stent-graft, which is kept in a compressed configuration by two separate containment sheaths 106 and 108. Each of the containment sheaths has an opening point 110 and 112. The stent-grafts and containment sheaths can be manufactured according to the widely discussed methods and materials, for example, in United States patents 6,042,605, 6,361,637 and 6,520,986, all deposited in the name of Martin et al. At the most distal end of the medical device, there is an olive 114. A channel for the guide wire 116 starts at the distal end of the olive and extends through catheter 102 and handling unit 100. Normally, a wire is used -guide during the implantation of the medical device, but, for the sake of clarity, it was preferred to omit it from the drawings. Inside the catheter 102, there are four distinct control lines 120, 122, 124 and 126. They will be used later on to cause the expansion of the medical device. Also illustrated is a first member 128, removably connected to the handling unit 100.
    [0033] [033] Figures 2A and 2B illustrate perspective views of the handling unit 100 and the medical device 104 during the first expansion step. In order to do this, the first member 128 is rotated in the direction of arrow 202 and then the same is pulled in the direction of arrow 204. The first control line 120 is connected to the first member 128. When pulling it, the first control line 120 is pulled together in the direction of arrow 206. The first control line 120 undoes the points of the distal containment 106 as it is pulled, allowing the distal part of the stent graft to auto-expand in the directions indicated by arrows 208. The first member 128 is pulled until the distal containment sheath is completely unraveled. When pulling the first limb further, the first control line 120 is completely removed from the catheter / manipulator and then discarded. While in the configuration shown in figure 2, the medical device 104 remains connected to catheter 102 by the proximal containment sheath 108. Furthermore, while in the configuration shown in figure 2, the anchors or tips 210 of the medical device 104 remain in a retracted or retracted configuration .
    [0034] [034] Figure 3A illustrates a perspective view of the handling unit 100 together with a partial side view of the distal part of the medical device 104 (figure 3B). After removing the first member 128 (figure 2), a second member 302 becomes accessible. A rotating part 304, in the form of a button, is connected to the second member 302. While in the configuration illustrated in figures 2 and 3, the position of the medical device can be precisely adjusted within the vasculature. For example, it is possible to move the handling unit 100 in the direction of arrow 306 in order to move or adjust the medical device in the longitudinal direction 306. Likewise, it is possible to rotate the manipulator in the direction of arrow 308 in order to rotate the device doctor. Longitudinal adjustment makes it possible to accurately align the medical device with a specific target within the vasculature, for example, in a very close position, but which does not obstruct a lateral vessel branch. The rotary adjustment also allows you to precisely align a bifurcated or branched device.
    [0035] [035] The longitudinal and rotational manipulations of the medical device are possible thanks to the connection of this to the catheter and thanks to the fact that the anchors are in the retracted configuration. When the medical device is correctly placed in the desired location, the device's anchors are released and are attached to the vascular wall. The release (or retraction) of the anchors is controlled by rotating the rotating part 304 in the directions indicated by the arrow 310. When rotating the rotating part 304, tension 312 is applied to the second control line 122 (or the same is removed) . The second control line 122 passes through the catheter and is then sewn around the distal part of the medical device's anchors. When tensioned, the second control line 122 causes the anchors to retract. By rotating the rotating part 304 in the opposite direction, the tension on the second control line 122 is reduced, allowing the part of the device with the anchors to self-expand in the direction of the arrow 314, thus engaging the anchors to the vascular wall.
    [0036] [036] After correctly aligning the medical device and engaging its anchors, the second control line 122 is removed. Figure 4 is a partial perspective view of the distal part of the self-expanding medical device 104 illustrating details of the second control line. In the illustration, the second control line 122 is inside a small tube 402 connected to catheter 102. In the illustration, the second control line 122 is sewn through the stent-graft. The second control line 122 culminates in a loop 404 attached to a third control line 124. When pulling the third control line 124 in the direction of arrow 406, loop 404 breaks apart, allowing the second control line 122 to be pulled in the direction 410. Then pull the second control line 122 until it is removed from the medical device.
    [0037] [037] To remove the second control line 122 from the medical device, first of all, it is necessary to pull the third control line 124 (in order to undo the loop of the second control line). This sequence of traction of the two control lines is controlled by the manipulator mechanism illustrated in figures 5A and 5B. The third control line 124 connects directly to the rotating part 304 so that, when rotating the second member 302 initially in the direction of the arrow 502, the control line is pulled in order to undo the loop 404 (figure 4). To rotate the second rotary member 302, it is necessary to activate a locking button 503 manually. The second control line 122 is confined to a rigid tube 504. Therefore, when rotating the second member 302, the rigid tube 504 rotates as shown in figure 5B. Therefore, the second control line 122 is not additionally tensioned, since the rigid tube maintains a constant length. Therefore, the rotation of the second member 302 will result in a differential movement between the third 124 and second 122 control lines. After rotating the second member 302 all the way, both control lines 122 and 124 can be moved at the same time. This mechanism can be used to activate more than two control lines.
    [0038] [038] As the perspective view of figure 6A and the partial side view of figure 6B illustrate, the second member 302, with the rotating part 304 connected to it, can then be removed by pulling it in the direction of arrow 602. As the second member 302 is pulled along with the rotating part 304, the two control lines 122 and 124 are pulled and completely removed from the device, catheter and manipulator. The second member 302 and the rotating part 304 are locked in such a way that it is not possible to remove them from the manipulator unless the knob is turned all the way, thus allowing the complete expansion of the medical device anchors. The rotation of the knob causes a follower nut to move to a rest position, thus releasing a lock to allow the subsequent removal of the second member 302. In addition, there may be a secondary lock, such as a button that needs to be activated manually to allow the removal of the second member 302. After the complete removal of the second member 302 and any control line connected to it, the distal part of the medical device 104, shown in part in figure 6, expands completely with the anchors 210 fully engaging vascular wall 604.
    [0039] [039] As the perspective views in Figures 7A and 7B illustrate, the second containment sheath 108 is released with the removal of a third member 702. The fourth control line 126 is connected to the third member 702 so that, when it is pulled in the direction of arrow 704, it is pulled in the direction of arrow 706. When pulled, the fourth control line 126 undoes the stitches on the second containment sheath 108, allowing the medical device to self-expand in the direction of 708 arrow. Then, the third member 702 and the fourth control line 126 connected to it are completely removed from the medical device, the catheter and the manipulator. Medical device 104 is now fully expanded and no longer connected to catheter 102. Therefore, the manipulator is pulled in the direction of arrow 710, thus removing the catheter from the vasculature and completing the expansion phase of the procedure. As an option, the second containment sheath 108 can be connected to the catheter or remain in the vasculature.
    [0040] [040] As shown in the perspective view of figure 8, the handling unit 100 can comprise an access port 802 that allows manual access to the various control lines if necessary. The access door 802 can be exposed, if desired, by removing a cover 804. The various control lines can be identified by colors, by alphanumeric signs, by order, by different sizes or formats or by any other means of identification. Control lines can incorporate features that allow you to grab and manipulate them using common tools.
    [0041] [041] The present invention is not limited to the use of limbs as specified above. Various other means of providing a mandatory interconnected activation sequence are possible. For example, interconnected activation mechanisms can include levers, sliding mechanisms, connections, tubes pulled in sequence and latches opened in sequence. With reference to figures 1 to 7, in general terms, the present invention proposes an interconnected activation system that comprises first, second and third mechanisms, each with a pre-activation and post-activation configuration. A first mechanism (first member 128) is found, in figure 1, in a pre-activation configuration and, in figure 2, in a post-activation configuration. A second mechanism (second member 302) is found, in figure 3, in a pre-activation configuration and, in figure 6, in a post-activation configuration. A third mechanism (third member 702) is, in figure 6, in a pre-activation configuration and, in figure 7, in a post-activation configuration.
    [0042] [042] In principle, the interconnected activation system of the present invention allows only the first mechanism to move from the pre-activation configuration to the post-activation configuration; in principle, the first mechanism (first member 128) is the only one accessible and the only one that can be activated.
    [0043] [043] The transition from the first mechanism of the pre-activation configuration to the post-activation configuration allows only the second mechanism to pass from the pre-activation configuration to the post-activation configuration; after removing the first mechanism, only the second mechanism (second member 302) becomes accessible and can be activated.
    [0044] [044] The passage from the second mechanism from the pre-activation configuration to the post-activation configuration allows only the third mechanism to pass from the pre-activation configuration to the post-activation configuration; after removing the second mechanism, only the third mechanism (third member 702) becomes accessible and can be activated.
    [0045] [045] The present invention is not limited to interconnected sequences using control lines. For example, the concepts of the present invention can include interconnected devices that activate electrical contacts. These contacts can use the conductance of the various components of the manipulator so that an electrical contact opens with the removal of a specific component from the manipulator. The manipulation of a specific component of the manipulator can also activate a simple electrical switch. The manipulation of a specific component of the manipulator can also activate proximity sensors, pressure sensors, fluid flow sensors or other types of sensors. Combinations of various drivers can also be incorporated into the designs of the present invention. For example, it is possible to combine control lines with electrical switches. In addition to portable manipulators or handles, the various concepts of the present invention can also be incorporated into activation devices with a control panel.
    [0046] [046] Typical manipulators, tools or catheters used to implant medical devices may comprise materials widely known as amorphous general purpose thermoplastics, which include polymethylmethacrylate (PMMA or acrylic), polystyrene (PS), acrylonitrileabutadiene-styrene (ABS), polyvinyl chloride (PVC), glycol modified ethylene terephthalate (PETG) and cellulose acetate butyrate (CAB); semi-crystalline general purpose plastics, which include polyethylene (PE), high density polyethylene (HDPE), low density polyethylene (LDPE or LLDPE), polypropylene (PP) and polymethylpentene (PMP); amorphous engineering thermoplastics, which include polycarbonate (PC), polyphenylene oxide (PPO), modified polyphenylene oxide (Mod PPO), polyphenylene ether (PPE), modified polyphenylene ether (Mod PPE) and thermoplastic polyurethane (TPU); semicrystalline engineering thermoplastics, which include polyamide (PA or nylon), polyoxymethylene (POM or acetal), polyethylene terephthalate (PET, thermoplastic polyether), butylene polyterephthalate (PBT, thermoplastic polyester) and ultra-high molecular weight polyethylene (UHMW -FOOT); high performance thermoplastics, which include polyimide (PI, imidized plastic), polyamide-imide (PAI, imidized plastic) and polybenzimidazole (PBI, imidized plastic); high-performance amorphous thermoplastics, which include polysulfone (PSU), polyetherimide (PEI), polyether sulfone (PES) and polyaryl sulfone (PAS); high-performance semicrystalline thermoplastics, which include polyphenylene sulfide (PPS) and polyether ether ketone (PEEK); and high-performance semicrystalline thermoplastics, fluoropolymers, which include fluorinated ethylene-propylene (FEP), ethylene-chlorotrifluorethylene (ECTFE), polychloro-trifluorethylene (PCTFE), polytetrafluoroethylene (PTFE), polyvinylidene fluoride (PVDF) and perfluoro. Other known medical-grade materials include organosilicon elastomeric polymers, polyether-block-amide or thermoplastic copolyether (PEBAX) and metals, such as stainless steel and nickel / titanium alloys.
    [0047] [047] Common methods used in the construction of manipulators include general knowledge techniques for connecting two or more components. Examples of permanent connections include the use of glues, adhesives, welds, insertion molding, heavy pressure fittings, unidirectional locking or locking mechanisms, pressure pins, heat sealing and rivets. Examples of semi-permanent connections or that require a tool to separate components include screws, threaded parts, pressure rings and pressure fittings. Examples of connections that are removable or that can be separated by hand, without the use of additional tools, include pressure fittings, twist lock connectors, pressure removable mechanisms, removable tightening mechanisms, sliding levers, latches and light pressure fittings.
    [0048] [048] Control lines may comprise materials resistant to high tensile strength, such as carbon fibers, liquid crystal polymers and metallic wires. The control lines can adopt several transversal profiles, such as circular, oval, rectangular or in the form of other polygons. Control lines can also incorporate outer layers of lubrication, protective coatings or protective coatings to minimize friction.
    [0049] [049] Control lines can connect to the manipulator or activation mechanisms through various methods known as wrapping a control line around a pin or securing a line with screws. Other methods include passing a control line through a small hole and then forming knots or attaching a lump to the end of the line so that when pulling it, the knot or lump does not pass through the small hole. Adhesives, clamps, folds, fixing mechanisms, hot sealing, insertion molding and other commonly known connection methods can also be used to connect the control lines. As an alternative, it is possible to use a cable retention system or control lines to keep the wires inside the manipulator. Such a system comprises: at least one retaining element; a substrate with a cavity sized to allow the introduction of at least one retaining element; a first slot extending from a first edge of the substrate to said cavity; and a second slot extending from a second edge of the substrate to said cavity; wherein the first and second slits are dimensioned to allow the positioning of an elongated member, such as a thread, within them so that the retaining element keeps it within the cavity. The retaining element can be a ball bearing, a spherical element, a cylindrical rod or other similar means used to deform the elongated member. The cavity extends to a depth beyond the depth of the first and second slits, creating a space for bending or deforming the wire using the retaining element. The substrate cavity can be of any size or shape suitable for a retaining element to hold the wire within it. It is desirable for the cavity to be smaller in diameter than the retaining member to allow pressure engagement. If desired, it is possible to place an adhesive in the cavity before and / or after deforming the wire inside it, thus providing an additional fixing means. In order to keep an elongated member, such as a wire, inside a device, the following steps are taken. A manipulator is provided with a substrate comprising a cavity, a first slot and a second slot, as shown in figures 9A to 9F. At least one elongated member is inserted in the first and second slits in order to cross the cavity. At least one retaining element is inserted into the cavity in order to fix the elongated member between it and the substrate. The retaining element deforms the elongated member in order to hold it in place between it and the substrate.
    [0050] [050] This simple, easy to carry out, easily automated, visually verifiable and resistant connection concept is illustrated in figures 9A to 9F. Figure 9A shows a partial top view of a control line connection mechanism 900, while Figure 9B shows a side, partial and cross-sectional view along the plane A-A. A circular cavity 902 is illustrated, which culminates in a spherical shape 904. Slots first 906 and second 907 pass through the connection mechanism and penetrate the circular hole. The illustrated slits 906 and 907 are centered in relation to the center line of the cavity 902. Optionally, the slits can be arranged in non-centralized positions in the cavity. As shown in figure 9B, as an option, slot 906 “dips” into the edges 908 of the circular bottom of cavity 902, forming a curved channel when viewed along the transverse plane A-A.
    [0051] [051] As shown in figures 9C and 9D, a control line 910 is inserted in the first slot 906. With reference to figures 9E and 9F, in order to maintain and fix the control line in the connection mechanism, it is inserted with pressure a retaining element 912 in the cavity 902 along the direction indicated by the arrow 914. When fully engaged, the retaining element 912, in this case a rigid sphere, deforms the control line, giving it the shape of the curved channel. The pressure and tight fit between the cavity 902 and the retaining element 912 effectively secures the control line to the connection mechanism. Then, the control line can be tensioned in any of the 916 directions without sliding or leaving the connection mechanism. If desired, it is possible to stick an adhesive on the accessible part of the rigid sphere in order to further increase the retention of the control line. As an option, the accessible part of the cavity can also be “hot sealed” or deformed to further force the rigid sphere and the control line. As an option, cavity 902 can incorporate alignment guides for the retaining element, such as projecting vertical shoulders, chamfers, tapers or other means for aligning the retaining element with the hole.
    [0052] [052] The connection mechanism 900 can be made of plastics or metals of general knowledge, such as those listed above. The retaining element 912 can be a metallic ball bearing, a plastic sphere or a ceramic / glass sphere. A rigid roller or cylindrical element can be used instead of the rigid sphere to secure control lines in the form of tape. Other shapes of rigid elements and corresponding holes can be used to connect various elements, as desired. In addition, the rigid element can be transparent to allow visual inspections.
    [0053] [053] The connection mechanisms of the present invention can also be used to fix electrically conductive materials, such as wires or cables. The connection mechanisms of the present invention can also be used to fix materials that do not conduct electricity, such as optical fibers, fabrics, polymers or natural biomaterials, such as blood vessels or nerves.
    [0054] [054] The connection mechanism can also be used to release a rope or cable at a predetermined load. For example, the connection mechanism, the substrate, the cable and the retaining element can have various tolerances, a specific stiffness or specific surface features that together result in a predetermined holding load. EXAMPLES EXAMPLE 1
    [0055] [055] We manufacture an apparatus according to an embodiment of the present invention in order to test the retention force of test cables. As shown in the top view in figure 10A and the perspective view in figure 10B, we built a connection mechanism 1000 with a substrate 1002. The substrate 1002 contained a cavity 1006, sized to accept a cable 1008 and a retaining sphere 1004. The figures 10C and 10D are seen in cross-section along the center line of cavity 1006. As shown, we insert a cable 1008 into cavity 1006. Then, we insert a retaining ball 1004 into cavity 1006 by pressure, thus deforming the cable, as illustrates figure 10D. Then, we placed a medical-grade UV curable adhesive over the cavity, partially covering the cavity itself, the sphere and the deformed cable. EXAMPLE 2
    [0056] [056] We placed cable sections in devices like the one in example 1, insert balls by pressure in the cavities and apply an adhesive as a coating. The compression loads required to press and seat the spheres were recorded using an Ametek® (Paoli, PA) Chatillion® DFX-050 compression gauge. After curing the adhesive, we tension the cables to determine the holding load. We tension the cables using an Instron® voltage tester and load cell (Norwood, MA). We analyzed twenty units.
    [0057] [057] In figures 11 to 13, a manipulation unit 100 'is illustrated according to an alternative embodiment of the invention for use in the implantation of a medical device by means of several implant lines passing through a catheter 102'.
    [0058] [058] The handling unit 100 'includes several removable members 128', 302 'and 702'; each one connected to at least one of the several lines. Each of the various lines is operationally coupled to the medical device for implantation or selective activation thereof. The various removable members 128 ’, 302’ and 702 ’interconnect in series in a removable manner in such a way that, at any given time, only one of them presents itself for manipulation by the user. The use and removal of each of the removable members 128 ', 302' and 702 'introduces another of the removable members 128', 302 ', 702' for manipulation by the user.
    [0059] [059] The handling unit 100 'also includes a driving means 150 for displacing a wire 152 (indicated by a dotted line in figures 11 and 12) that passes through the catheter 102' in order to drive the medical device independently of the various members removable 128 ', 302' and 702 '. In one embodiment, wire 152 can be used as a conduction wire to conduct the distal end of catheter 102 'and / or the device. The drive mechanism 150 includes a threaded rod 154, which extends along a longitudinal axis 156, and a nut 158, which threads onto the rod 154. Nut 158 moves along longitudinal axis 156 in response to the selective rotation of the stem 154 about the longitudinal axis 156. The wire 152 mates with the nut 158 and moves along with it along a direction largely parallel to the longitudinal axis 156 during the selective rotation of the stem 154 around the longitudinal axis 156. More specifically, an end 160 of wire 152 curves and extends into a slot or passageway 162 formed in nut 158. Wire 152 is retained in a largely radial direction between nut 158 and stem 154, although it remains mobile with nut 158 in a direction largely parallel to the longitudinal axis 156 of nut 158.
    [0060] [060] The handling unit 100 'also includes a housing 170 with a distal part 172 adapted to receive and support the proximal end of the catheter 102'. The housing 170 also includes a proximal part 174 largely opposed to the distal part 172.
    [0061] [061] A substantially rigid tube 176 is fixedly connected to housing 170 and extends along the longitudinal axis 156 of stem 154. Tube 176 extends longitudinally between the opposite ends of the first 177 and the second 178. The tube 176 is fixedly connected to housing 177 at or near the first end 177. In one embodiment, the first end 177 of tube 176 is fixedly connected to the inner wall 179 of housing 170. Tube 176 passes through a central hole 155 in stem 154 and includes a largely cylindrical outer surface 175 around which the stem 154 rotates about the longitudinal axis 156. Tube 176 also includes an inner surface 173, which defines an orifice 171 that passes through it. The orifice 171 is largely continuous with respect to at least one channel or guide wire channel 116 'in the catheter 102' to allow a guide wire 149 to be inserted through the catheter 102 'and through the handling unit 100'. Thus, tube 176 provides an external support surface 175 to support the rotation of rod 154 about longitudinal axis 156 and also includes an orifice 171 to allow a guide wire 149 to pass through the handling unit 100 'leaving the part distal 172 of housing 170 of handling unit 100 '. This allows the design of a compact housing unit that is easier for the user to manipulate and minimizes disturbances to the user's overall working environment.
    [0062] [062] An adapter 180 attaches securely to the second end 178 of tube 176. Adapter 180 includes an opening 182 that is largely continuous with orifice 171 of tube 176. With this arrangement, wire 149 can pass through catheter 102 ', orifice 171 in tube 176 and opening 182 in adapter 180. Adapter 180 includes a threaded portion 186 to which it is possible to attach a cap or other accessories. In one embodiment, the adapter is a Tuohy Borst adapter.
    [0063] [063] Alternatively, a cannulated member (not shown) can be disposed in the orifice of the tube. The cannulated member can be a largely continuous channel with respect to at least one channel or guidewire channel in the catheter to allow the guidewire to be inserted through the catheter and through the manipulation unit. In addition, one end of the cannulated member can be attached to the adapter to provide a seal that prevents fluid leakage into or out of the manipulator housing.
    [0064] [064] It is contemplated that other elongated members or several elongated members pass through the broadly continuous passage defined by the catheter, tube or cannulated member and / or adapter.
    [0065] [065] A button 194 can be rotatably coupled to the housing and mechanically to the stem 154 to facilitate its rotation around the longitudinal axis 156. The mechanical connection between the button 194 and the stem 154 can be direct or, alternatively, realized with a set of gears. It is possible to use other mechanisms to facilitate the rotation of the rod 154 around the nut 158 or any other type of displacement of the nut along the longitudinal axis 156, such as by levers, rotating wheels, slides and the like.
    [0066] [066] Although specific embodiments of the present invention have been described and illustrated in the present document, it is not limited to such descriptions and illustrations. It should be borne in mind that it is possible to carry out and incorporate changes and modifications as part of the present invention without, therefore, departing from the scope of the following claims.
    权利要求:
    Claims (11)
    [0001]
    Manipulation unit (100) for use in the implantation of a medical device (104) by means of several implant lines passing through a catheter (12), characterized by comprising: several removable members (128 ', 302', 702 ') displaced from a longitudinal axis (156) of the handling unit (100) and each connected to at least one of the several lines, where each of the several lines it is operationally coupled to the medical device (104) for the implant or selective activation thereof, the various removable members connecting in a removable way in such a way that only one of them presents itself for manipulation by the user and in such a way that the removal of each of them introduces another one of them for manipulation by the user; and a drive mechanism (150) along the longitudinal axis (156) of the handling unit (100) to move a wire (152) through the catheter (12) in order to drive the medical device (104) independently of the various members removable.
    [0002]
    Handling unit (100) according to claim 1, characterized in that the drive mechanism includes a threaded rod (154), which extends along a longitudinal axis (156), and a nut (158 ), which attaches to the wire (152) and screw onto the rod (154), in such a way that the wire (152) moves along with the nut (158) along the longitudinal axis (156) in response to selective rotation of the rod (154) about the longitudinal axis (156).
    [0003]
    Handling unit (100) according to claim 2, characterized in that it includes a tube (176) aligned to the longitudinal axis (156) in a largely coaxial manner.
    [0004]
    Handling unit (100) according to claim 3, characterized in that the rod (154) includes a central hole (155), which receives the tube (176) through itself, and is rotatable about the axis longitudinal (156).
    [0005]
    Handling unit (100) according to claim 3, characterized in that the tube (176) includes an orifice (171) that extends longitudinally and is largely continuous with respect to at least one channel that passes through the catheter (12) so that a guidewire (116) can be inserted through the catheter (12) and the tube (176).
    [0006]
    Handling unit (100) according to claim 5, characterized in that it includes a housing (170) that extends between a distal part (172) and an opposite proximal part (174), the distal part (172) receiving and supporting the proximal end of the catheter (12).
    [0007]
    Handling unit (100) according to claim 6, characterized in that the orifice (171) of the tube (176) extends between the catheter (12) and the proximal part (174) of the housing (170) , such that the guide wire (116) can be fed from the catheter (12) and through the tube (176) leaving the housing (170) close to the proximal part (174).
    [0008]
    Manipulation unit (100) according to claim 1, characterized by the fact that the wire (152) is a conduction wire to conduct the distal end of the catheter (12).
    [0009]
    Handling unit (100), according to claim 1, characterized by the fact that the drive mechanism comprises: a threaded rod (154) extending along a longitudinal axis (156); a nut (158) screwed onto the rod (154) and attached to one end of the wire (152) so that the nut and the wire travel together widely along the longitudinal axis (156) in response to the selective rotation of the rod (154 ) around the longitudinal axis (156); and a tube (176) extending through the rod (154) and rotatingly coupled to it in order to rotate it around the longitudinal axis (156), wherein the tube (176) further includes an orifice (171) largely continuous with respect to at least one channel in the catheter (12) to allow guiding a guidewire (116) through the catheter (12) and through the unit handling (100).
    [0010]
    Handling unit (100), according to claim 1, characterized by the fact that the drive mechanism comprises: a threaded rod (154) extending along a longitudinal axis (156); a nut (158) screwed onto the rod (154) and attached to one end of the wire (152) so that the nut and the wire travel together widely along the longitudinal axis (156) in response to the selective rotation of the rod (154 ) around the longitudinal axis (156); and a tube (176) with an external support surface (175), which rotatably supports the threaded rod (154) so that it rotates around the longitudinal axis (156), and an internal surface (173), which defines an orifice (171) largely continuous with respect to a channel in the catheter (12) to allow a guidewire (116) to pass through the catheter (12) and the handling unit leaving the handling unit.
    [0011]
    Manipulation unit (100) according to claim 10, characterized in that the wire (152) is a conduction wire to conduct the distal end of the catheter (12).
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    法律状态:
    2018-03-27| B15K| Others concerning applications: alteration of classification|Ipc: A61M 25/01 (2006.01), A61F 2/95 (2013.01), A61F 2/ |
    2018-12-26| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2019-11-26| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2020-07-28| B07A| Technical examination (opinion): publication of technical examination (opinion) [chapter 7.1 patent gazette]|
    2020-12-01| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2021-02-17| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 16/08/2011, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    US37456010P| true| 2010-08-17|2010-08-17|
    US61/374,560|2010-08-17|
    US13/210,205|US9326872B2|2010-08-17|2011-08-15|Forced deployment sequence handle assembly with independent actuating mechanism|
    US13/210,205|2011-08-15|
    PCT/US2011/047938|WO2012024308A1|2010-08-17|2011-08-16|Forced deployment sequence handle assembly with independent actuating mechanism|
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