Orthopedic implant kit

Abstract

An orthopedic implant kit comprising a screw expander comprising a hollow cylindrical body comprising two opposing longitudinal slits having open ends toward a distal portion of the hollow cylindrical body configured to receive a screw by insertion along a main axis of the hollow cylindrical body, the hollow cylindrical body comprising an internal thread; a screw manipulation tool having an external thread configured to threadedly engage the internal thread of the hollow cylindrical body of the screw expander, the screw manipulation tool comprising a longitudinal housing, a rotatable shaft inside the longitudinal housing, the rotatable shaft having a distal portion configured to engage the screw, and a blocking mechanism configured to block rotation of the rotatable shaft relative to the longitudinal housing in a blocking position and configured to allow rotation of the rotatable shaft relative to the longitudinal housing in a non-blocking position.

Description

[0001] This application is a divisional application of the invention patent application with application number 201910770339.2 (the original application's application number is 201480027310.0), application date of April 24, 2014, and invention title "Orthopedic Implant Kit". Technical Field

[0002] This invention relates to orthopedics, and more particularly to orthopedic devices, such as pedicle screws, rods, and spinal cages. The invention also relates to tools for operating these devices. Background Technology

[0003] US 2013 / 0012999 discloses an orthopedic implant kit comprising several instruments, particularly pedicle screws fixed to an installation tube made of two easily removable half-shells.

[0004] Existing pedicle screw technology can be divided into two main categories:

[0005] - Single-axis screw: The direction of the screw spindle is fixed relative to the screw head;

[0006] - Multi-axis screws: The orientation of the screw spindle can be freely changed relative to the screw head.

[0007] Inserting pedicle screws into the bone involves several steps. Almost every step requires the use of specialized tools. Summary of the Invention

[0008] One object of the present invention is to reduce the number of instruments required for manipulating and fixing orthopedic implants (pedicle screws, nuts, rods, etc.).

[0009] Another objective is to reduce the number of tools used to operate these instruments.

[0010] Another purpose is to assist in operating these tools.

[0011] These objectives are achieved by using the implantation kits as defined in the claims, as well as related appliances and tools.

[0012] In a first embodiment of the present invention, an orthopedic implant kit includes a lockable multi-axis screw, a tissue expansion sleeve, a screw driver, a screw extender, a rod, a rod reset device, a positioning screw driver, a torque limiting mechanism, and a screw release tool.

[0013] The lockable multi-axis orthopedic screw according to the invention comprises a head and a threaded portion, which form two separate elements secured to each other, but each element can be oriented independently along a specific direction. For example, the threaded portion can rotate about the screw head and can adopt several possible orientations. More precisely, the threaded portion can be oriented in any direction within a conical volume, the apex of the cone corresponding to the contact point between the head and the threaded portion.

[0014] The screw also includes a locking element that, when activated, inhibits relative movement between the threaded portion and the head. This configuration is referred to as "single-axis" because the threaded portion can be oriented relative to the head along a single (fixed) axis. According to one embodiment, the locking element is a clamp with a U-shape. In this case, the head and threaded portion contain chambers adapted to receive branches of the U-shaped clamp.

[0015] Preferably, in the single-axis mode, the head can still rotate freely about its own axis relative to the threaded portion. This mechanism can be achieved using a U-shaped clamp and an annular groove located around the upper part of the threaded portion. In this case, the branches of the clamp slide into the annular groove.

[0016] In another embodiment, the screw head includes at least one longitudinal release mechanism, such as a groove or ridge, sized to receive a corresponding release mechanism, such as a ridge or groove located within the distal end of the screw extender.

[0017] In another embodiment, the screw includes a recess in the proximal end of the threaded portion and a corresponding convex shape in the distal portion of the screw head. This configuration reduces the screw length and increases the strength and rigidity of the system.

[0018] The screw extender according to the invention comprises a hollow cylindrical body made of two half-tubes separated by two opposing longitudinal slits having open ends toward a distal portion of the cylindrical body, the distal portion being sized to receive and retain a screw head. The cylindrical body also includes an internally threaded portion.

[0019] According to one embodiment, the cylindrical body is made from a single piece, wherein the distal portion is radially expandable by means of its own elasticity, thereby allowing easy clamping and subsequent release of the screw head.

[0020] To aid in its radial expansion, the screw extender may include an expansion device, such as an internal rotatable tube that, when rotated, pushes the two halves of the tube away from each other.

[0021] In a preferred embodiment, the interior of the distal end of the cylindrical body includes at least one release mechanism, such as a ridge or groove, sized to be received within a longitudinal release mechanism of the screw head (which includes a corresponding release mechanism, as described above). This configuration prevents the distal portions of the half-tube from separating from each other through their own elasticity, thus creating a very strong attachment between the screw extender and the screw head. An additional benefit is the avoidance of relative rotation between the screw head and the cylindrical body.

[0022] In a preferred embodiment, the rod reset tool is located inside the cylindrical body.

[0023] Advantageously, the rod reset tool is essentially made of a shaft with a threaded distal portion that corresponds to the threaded portion inside the cylindrical body. Therefore, as it rotates within the cylindrical body, the shaft can move along the main axis of the cylindrical body.

[0024] In another embodiment, the locating screw driver (similarly, or optionally) is located within the cylindrical body. In this case, the locating screw driver may also be essentially made of a shaft with a threaded distal portion.

[0025] Advantageously, the locating screw driver includes a torque limiting mechanism.

[0026] In one embodiment, the mechanism includes a breakable pin and a threadless rotatable shaft. The pin passes laterally through the rotatable shaft and its end is secured within the threaded rotatable shaft. The threaded and threadless shafts are rotatably connected to each other, but when a specific torque is reached, the pin breaks, and each shaft can rotate freely relative to the other.

[0027] In another embodiment, the screw release tool (similarly, or optionally) is located within the cylindrical body.

[0028] Advantageously, screw release tools are essentially made of a shaft with a threaded distal end.

[0029] In one particularly interesting embodiment, the same shaft with a threaded distal portion is used for the rod reset tool (and potential spinal slippage), the positioning screw driver, and the screw release mechanism.

[0030] The tissue expansion sleeve according to the invention includes a flexible conical portion adapted to be temporarily attached to the distal portion of a tool such as a screw extender as defined in the preceding claims.

[0031] In one embodiment, the conical portion is made of several longitudinal flexible blades, each blade having a generally triangular shape. Attached Figure Description

[0032] The invention will be better understood in the following description, in conjunction with the non-limiting examples shown in the accompanying drawings, in which:

[0033] Figure 1 An implantation kit according to the present invention is shown.

[0034] Figure 2 An example of a lockable multiaxial pedicle screw according to the present invention is shown.

[0035] Figures 3A to 3C yes Figure 2 The cross-section and partial cut-out view of the screw.

[0036] Figure 4 express Figure 2 Different views of the screw (full and partial).

[0037] Figure 5 The distal portion of the screw extender according to the invention is shown, and Figure 2 The screw.

[0038] Figure 6 It is the cross-section of the distal portion of the screw extender.

[0039] Figure 7 This is a global view of a screw extender with screws.

[0040] Figures 8A to 8C This indicates the positioning of the rod in the screw head, the rod's reset, and the tightening of the positioning screw.

[0041] Figures 9A to 9C The screw is shown being released relative to the screw extender.

[0042] Figure 10 A screw extender is shown, which includes a mechanism for laterally extending the distal portion of the screw extender.

[0043] Figure 11 yes Figure 10 Another representation of a screw extender.

[0044] Figure 12 Another embodiment of the pedicle screw according to the present invention is shown.

[0045] Figures 13A to 13C Different views of a rotatable shaft are shown, which is used in rod reset tools, positioning screw drivers, and screw release tools.

[0046] Figure 14 and 15 The torque limiting mechanism is shown.

[0047] Figure 16 and 17The use of tissue expansion sleeves is shown.

[0048] Figures 18 to 38 A surgical procedure using the implant kit according to the invention is shown.

[0049] Explanation of reference numerals in the attached figures:

[0050] 1. Pedicle screw

[0051] 2. Head

[0052] 3. Positioning screws

[0053] 4. Threaded section

[0054] 5. Locking element

[0055] 6. Screw extender

[0056] 7. Pole

[0057] 8. The upper part of the multi-function tool

[0058] 9. Tissue expansion sleeve

[0059] 10. Torque driver

[0060] 11. Head passage

[0061] 12. Threaded section channel

[0062] 13. Branches

[0063] 14. Cylindrical main body

[0064] 15. Slit

[0065] 16. The distal part of the cylindrical main body

[0066] 17. Spine

[0067] 18. Slot

[0068] 19. Internal threaded portion of the screw extender

[0069] 20. The lower part of the multi-function tool

[0070] 21. Conical section

[0071] 22. Leaf

[0072] 23. Half-pipe

[0073] 24. Screw driver

[0074] 25. Handle

[0075] 26. Multi-tool (rod reset / locating screw driver / screw release)

[0076] 27. Rod Insertion Tool

[0077] 28. Can be discontinued

[0078] 29. Horizontal pin

[0079] 30. Circular groove

[0080] 31. Puncture needle / guidewire

[0081] 32. Top of concave screw

[0082] 33. A convex upper hemisphere Detailed Implementation

[0083] The examples below more appropriately refer to thoracolumbar fusion systems consisting of pedicle screws and rods combined with single-use tools. A typical pedicle screw system consists of a screw implant and a tool for placing the screw.

[0084] Figure 1 An example of an implantation kit according to the present invention is shown.

[0085] The kit includes a tissue expansion sleeve 9, a handle 25, a rod 7, a rod insertion tool 27, a shaft 26 which can be used as a rod reset tool and / or a positioning screw driver and / or a screw release tool, a pedicle screw 1, a screw extender 6, and a screw driver 24.

[0086] Specifically Figures 2 to 4 The lockable multi-axis screw 1 shown includes a head 2 and a threaded portion 4. Figure 2 Also shown is a positioning screw 3, which can be secured to the head after the rod 7 is inserted. The screw 1 also includes a U-shaped locking element 5. When the locking element 5 is fully inserted into the screw head 2, the orientation of the threaded portion 4 relative to the head 2 is prevented. Conversely, when the locking element is pulled out, the threaded portion 4 can be freely oriented relative to the screw head 2.

[0087] Therefore, the lockable multi-axis screw according to the invention can be modified into a single-axis screw, thereby allowing single-axis and multi-axis functions in the same product. The previously defined blocking system allows the surgeon to choose whether he / she wants to use a single-axis or multi-axis mode screw. As described, the single-axis function is achieved by pushing in the locking element (clamp) 5, and the multi-axis function is achieved by removing the clamp 5. The clamp 5 is merely one example of the blocking system; other technical solutions, such as pins, are also conceivable.

[0088] Preferably, in the single-axis mode, the head can still rotate freely about its own axis relative to the threaded portion. This mechanism can be achieved using a U-shaped clamp and an annular groove located around the upper part of the threaded portion. In this case, the branches of the clamp slide into the annular groove.

[0089] When using a single shaft, any orientation of the shaft can be considered; that is, the screw shaft and the screw head can be oriented in different directions.

[0090] Figures 5 to 7 This indicates that the pedicle screw 1 is attached to the distal end 16 of the screw expander 6 by inserting the screw head 2 into the distal end 16. In this operation, the head 2 is guided by a plurality of ridges 17 located within the distal end 16 and a groove located on the head 2. Using this system, the screw head can be better retained in the screw expander 6.

[0091] Any suitable material can be used for screw extenders 6 (plastic, polymer, metal, etc.).

[0092] Figures 8A to 8C This indicates the positioning of the rod 7 in the screw head 2, the rod's reset, and the tightening of the positioning screw 3 in the screw head 2.

[0093] Multi-tool 26 (See also) Figures 13A to 13B It is defined by the upper part 8 and the lower (threaded) part 20.

[0094] The lever 7 can be pushed downwards by rotating the multi-tool 26 within the cylindrical body 14.

[0095] After the rod is inserted into the head 2, the positioning screw 3 is secured to the head 2 by further rotating the multi-tool 26.

[0096] Multitool 26 is also equipped with a torque limiting mechanism (see Figure 14 and 15 As the locating screw 3 is secured in the head 2 and the multi-tool 26 rotates further, the torque increases until it reaches a level that causes the pin 28 to break. Therefore, further rotation of the multi-tool 26 has no effect on the locating screw 3. From that point onward, further rotation of the multi-tool 26 only generates downward pressure on the screw head 2. Thus, the screw 1 gradually separates from the screw extender (see...). Figures 9A to 9C ).

[0097] This screw release mechanism from the tool provides the possibility of releasing the screw 1 from the screw extender without laterally expanding the screw extender 6.

[0098] At this stage, it's worth noting that this mechanism is not limited to releasing pedicle screws. Any other device can be used.

[0099] In summary, the same tool 26 can be used for rod reset, for securing the positioning screw to the screw head, and for releasing the screw from the screw extender.

[0100] It should be emphasized that the present invention is not limited to the three uses of the same tool described above. It may also include dual uses, such as rod reset and screw assembly to screw head fixation.

[0101] Figure 10 and 11 An alternative for attaching a pedicle screw to a screw extender is shown, in which the half-tube 23 expands elastically by rotating the inner tube (not shown). This allows the screw to be inserted and secured therein, for example, by clamping the outer surface around the screw. The same principle can be used as an alternative for separating the screw extender from the screw.

[0102] The clamping system also achieves partial rigidity by abutting against the support surface of the screw head.

[0103] Figure 12 The concave screw top 32 is shown, with a convex upper hemisphere 33 inside, which allows the rod 7 and the locating screw 3 to be positioned below the screw head 2, thereby reducing the overall height of the structure and increasing the strength and rigidity of the system.

[0104] Figure 16 and 17 The tissue expansion sleeve 9 comprises four triangular flexible blades 22 that intersect each other to form a cone 21. The cone 21 is attached to the tip of the screw expander 6 using a tear-off spiral. This allows tissue to be pushed aside when the screw expander 6 is inserted into the body. Once in place, the surgeon can remove the sleeve 9 while the screw expander remains in the body. Any appropriate number of blades can be used to form the cone.

[0105] Figures 18 to 38 The surgical procedure using the previously presented instruments is shown.

[0106] In the first step ( Figure 18 and 19 Two puncture guidewires 31 were positioned in the spine.

[0107] A first screw extender 6, attached with a screw 1 and surrounded by an expansion sleeve, then passes through the tissue. Figure 20 and 21 And it is inserted along guide wire 31. Screw expander 6 is rotated and / or pushed.

[0108] Perform a similar operation on the second screw expander 6 and screw 1. Figure 22 and 23 ).

[0109] Screw driver 24 is inserted into screw expander 6. Its distal end is introduced into the upper part of the screw thread 4. Screw 1 is then rotated and inserted into the vertebra ( Figure 24 and 25 ).

[0110] Remove tissue expansion sleeve 9 ( Figures 26 to 28 ).

[0111] The rod 7, with its end located at the rod insertion tool 27, traverses the tissue laterally. Figure 29 and 30 ).

[0112] Rod 7 is located above screw head 2 ( Figure 32 Furthermore, the multi-tool 26 is introduced into the screw expander 6, such that the positioning screw 3 is positioned above the rod 7, aligned with the screw head 2. Figure 31 and 32 ).

[0113] Figures 33 to 36 The rod is shown to be arranged in the screw head 2, and the positioning screw 3 is fixed to the screw head 2.

[0114] Figure 37 and 38 The screw is shown being released from the screw extender 6, and the screw 1, the rod 7, and the screw assembly 3 are in their final positions.

[0115] Of course, the present invention is not limited to these exemplary examples.

[0116] The screw extender according to the invention can be used with single-axis, multi-axis, or lockable multi-axis screws.

Claims

1. An orthopedic implant kit, comprising: Orthopedic screw extender (6) holds the head (2) of the orthopedic pedicle screw (1) in the distal portion (16) of the orthopedic screw extender (6) for rotation into the vertebra; and A tissue expansion sleeve (9) is removably attached to the orthopedic screw extender (6), the tissue expansion sleeve (9) comprising: The cylindrical portion surrounds the orthopedic screw extender (6). A flexible conical portion (21) is attached to one end of the cylindrical portion. The flexible conical portion tapers gradually in a direction away from the cylindrical portion. The flexible conical portion (21) includes a plurality of longitudinal flexible blades (22), each flexible blade having a generally triangular shape. The flexible blades interact with each other and form a cone. handle, The flexible conical portion (21) is mounted on the tip of the orthopedic screw extender (6) and surrounds the orthopedic pedicle screw (1), and the flexible conical portion (21) is configured such that when the orthopedic screw extender (6) holding the orthopedic pedicle screw (1) is inserted into the body to rotate the orthopedic pedicle screw (1) into the vertebra, the tissue is pushed aside.

2. The orthopedic implant kit according to claim 1, wherein, The handle includes a ring.

3. The orthopedic implant kit according to claim 1, wherein, When the tissue expansion sleeve is removed, the flexible blades of the flexible conical portion are configured to bend radially away from the orthopedic screw extender.

4. The orthopedic implant kit according to claim 1, wherein, The orthopedic screw extender (6) includes a hollow cylindrical body (14) made of two half-tubes (23) separated by two opposing longitudinal slits (15) having open ends toward a distal portion (16) of the cylindrical body, the distal portion (16) being sized to receive and retain a screw head (2), wherein the cylindrical body (14) includes an internally threaded portion (19).

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