WO2023125567A1 - 脊椎稳定系统 - Google Patents

脊椎稳定系统 Download PDF

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Publication number
WO2023125567A1
WO2023125567A1 PCT/CN2022/142489 CN2022142489W WO2023125567A1 WO 2023125567 A1 WO2023125567 A1 WO 2023125567A1 CN 2022142489 W CN2022142489 W CN 2022142489W WO 2023125567 A1 WO2023125567 A1 WO 2023125567A1
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WO
WIPO (PCT)
Prior art keywords
fixing
stabilization system
wire
needle tube
wire body
Prior art date
Application number
PCT/CN2022/142489
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English (en)
French (fr)
Inventor
吴孟晃
Original Assignee
台北医学大学
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Filing date
Publication date
Application filed by 台北医学大学 filed Critical 台北医学大学
Publication of WO2023125567A1 publication Critical patent/WO2023125567A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/01—Orthopaedic devices, e.g. splints, casts or braces

Definitions

  • the present invention relates to a spinal stabilization system, in particular to a spinal stabilization system which can fix an auxiliary line body on the spinal ligament to increase the stability of the spine.
  • the traditional spinal fixation system only fixes a plurality of bone screws to the vertebrae, and then fixes the bone screws to each other through connecting rods, so as to achieve the effect of fixing the spine to the correct position and angle.
  • this traditional spinal fixation system only the vertebrae with bone screws can be fixed to each other, and for the connection between vertebrae (such as between the vertebrae with bone screws and the vertebrae without bone screws), Mobility or relative motion does not provide any assistance, resulting in the disadvantage of insufficient spinal stability.
  • a spinal stabilization system that can fix the auxiliary wire body on the spinal ligament to increase the stability of the spine.
  • one idea of the present invention is to provide a spinal stabilization system that can fix the auxiliary wire body on the spinal ligament to increase the stability of the spine.
  • the present invention provides a spine stabilization system, comprising: a wire body having a first end of the wire body and a second end of the wire body; a first fixing member connected to the first end of the wire body; a wire body control member , the second end of the thread body is connected to the thread body control part, and a part of the thread body is movably arranged on the thread body control part; and the first auxiliary fixing device has a needle tube part and a first accommodating part ; wherein when the spinal stabilization system is in the first state of use, the thread body together with the thread body control member is detachably connected to the first auxiliary fixation device; wherein when the spine stabilization system is in the first state of use, the The thread system is partially accommodated in the needle tube portion, and the thread body control member is connected to the first accommodating portion of the first auxiliary fixing device.
  • the thread body is elastic.
  • the needle tube part has a slot
  • the slot hole is extended on the needle tube part
  • the thread body extends from the slot hole to the outside of the needle tube part and connects with the thread body control member .
  • the wire control part has a gear part, and the gear part contacts the first accommodating part, and the wire control part prevents the wire control part from being in a move relative to the first accommodating portion in a specific direction.
  • the wire control member has a rod portion, and the first accommodating portion of the first auxiliary fixing device has a first open groove portion; wherein when the spinal stabilization system is in the first In a use state, the wire control part is detachably connected to the first open groove part of the first auxiliary fixing device through the rod part.
  • the first auxiliary fixing device has a push-out mechanism, and the first auxiliary fixing device uses the push-out mechanism to push the first fixing part outward from the needle tube part, so that the The first fixing element is fixed on the target spinal ligament.
  • the push-out mechanism is that the first auxiliary fixing device has a push rod and a push rod channel, and the push rod channel communicates with the needle tube; wherein the push rod enters the needle tube through the push rod channel part, and push the first fixing part outward from the needle tube part.
  • the spinal stabilization system further includes: a plurality of second fixing parts, the plurality of second fixing parts are respectively connected to the wire body; wherein when the spinal stabilization system is in the first use state When, at least one of the first fixing element and the plurality of second fixing elements is accommodated in the needle tube part.
  • the first fixing part has a first piercing part and a first connecting part, and the first fixing part is connected to the wire body through the first connecting part;
  • the plurality of second The fixing parts respectively have a second piercing part and a second connecting part, and the plurality of second fixing parts are respectively connected to the wire body through the corresponding second connecting parts.
  • the first auxiliary fixing device has a push-out mechanism, and the first auxiliary fixing device pushes one of the first fixing piece and the plurality of second fixing pieces through the pushing-out mechanism. Push out from the inside of the needle tube to fix it on the target spinal ligament.
  • the spine stabilization system further includes: a second auxiliary fixation device having a second accommodating portion; wherein when the spine stabilization system is in the second use state, the first fixation member is fixed on the target spinal ligament, and the thread body and the thread body control part are detachably connected to the second auxiliary fixation device; wherein when the spinal stabilization system is in the second use state, the thread body control part is connected to the first The second accommodating portion of the two auxiliary fixing devices.
  • the second auxiliary fixing device has a wire body fixing member and a fixing mechanism; the second auxiliary fixing device uses the fixing mechanism to fix the wire body on the wire body fixing member and the fixing mechanism. Between the target connecting rods.
  • the wire control member has a rod portion, and the second accommodating portion of the second auxiliary fixing device has a second open groove portion; wherein when the spinal stabilization system is in the first 2.
  • the wire control part is detachably connected to the second open groove part of the second auxiliary fixing device through the rod part.
  • a spinal stabilization system comprising: a thread body; a first fixing member, connected to the thread body; and an auxiliary fixing device, including: a main body; a needle tube portion, connected to the main body, the thread body a part is arranged in the needle tube part, and the thread body and the first fixing part can move relative to the needle tube part; a push rod part is arranged in the needle tube part, and the push rod part can move relative to the needle tube part;
  • the control part is connected with the push rod part; wherein the control part moves the push rod part relative to the needle tube part, so as to make the thread body and the first fixing part move relative to the needle tube part through the push rod part.
  • control part has a first thread
  • push rod part has a second thread
  • control part is screwed with the second thread of the push rod through the first thread Connection; wherein the control part and the push rod part are screwed together to move, so as to make the push rod part move relative to the needle tube part.
  • control part is connected to the main body, and the control part can move relative to the main body.
  • the main body part has a groove part, and the groove part has a groove extending direction; wherein the push rod part has a groove connection part, and the groove connection part is partially arranged on the In the groove part; wherein the push rod part moves relative to the main body part along the extending direction of the groove through the groove connection part.
  • the auxiliary fixing device includes: a thread control member connected to the main body, and the thread control member can move relative to the main body; wherein the first fixing member is connected to the The first end of the thread body; wherein the second end of the thread body is connected to the thread body control part, and a part of the thread body is movably arranged on the thread body control part.
  • the needle tube part has a slot
  • the slot hole is extended on the needle tube part
  • the thread body extends from the slot hole to the outside of the needle tube part and connects with the thread body control member .
  • the wire body control member has a first fixing part
  • the auxiliary fixing device includes: a second fixing part, which is arranged on the main body part, and the second fixing part can be opposite to the The main body moves; wherein when the second fixing part is in the first state, the second fixing part contacts the first fixing part, so that the wire control part cannot move relative to the main body in the first direction; Wherein when the second fixing part is in the second state, the second fixing part and the first fixing part are separated from each other.
  • the first fixing portion is a gear portion disposed on the wire control member.
  • the thread body is elastic.
  • the spine stabilization system further includes: a plurality of second fixing parts, the plurality of second fixing parts are respectively connected to the wire body; wherein the first fixing part and the plurality of second fixing parts At least one of the fixing parts is accommodated in the needle tube part.
  • the first fixing part has a piercing part and a connecting part, and the first fixing part is connected to the wire body through the connecting part.
  • Fig. 1 is a schematic diagram of a specific embodiment of the spine stabilization system of the present invention in a first use state.
  • FIG. 2A is a schematic diagram of a specific embodiment of the wire body and the fixing member of the spinal stabilization system of the present invention.
  • Fig. 2B is a schematic diagram of a specific embodiment of the fixing member of the spinal stabilization system of the present invention.
  • Fig. 3 is a schematic diagram of a specific embodiment of fixing the fixing member of the spinal stabilization system to the spinal ligament of the present invention.
  • Fig. 4 is a schematic diagram of a specific embodiment of the wire body control part and the first auxiliary fixation device of the spinal stabilization system of the present invention.
  • Fig. 5 is a schematic diagram of a specific embodiment of the first auxiliary fixation device of the spinal stabilization system of the present invention.
  • Fig. 6 is a schematic diagram of a specific embodiment of the spine stabilization system of the present invention in a second use state.
  • Fig. 7 is a schematic diagram of a specific embodiment of the thread body fixing member of the present invention.
  • Fig. 8 is a schematic diagram of a specific embodiment of the wire body control part of the spinal stabilization system of the present invention.
  • Fig. 9 is a schematic diagram of a specific embodiment of the application of the thread body, the fixing element and the thread body fixing element to the target spinal ligament of the spinal stabilization system of the present invention.
  • Fig. 10A is a schematic diagram of a specific embodiment of the spinal stabilization system of the present invention.
  • Fig. 10B is a schematic diagram of a specific embodiment of the spinal stabilization system of the present invention.
  • FIG. 10C is a schematic diagram of a specific embodiment of the control unit of the spinal stabilization system of the present invention.
  • FIG. 10D is a schematic diagram of a specific embodiment of the wire body control member and the second fixing part of the spinal stabilization system of the present invention.
  • Fig. 11 is a schematic diagram of a specific embodiment of the fixing member of the spinal stabilization system of the present invention.
  • the spinal stabilization system 100 includes a thread body 110 , a fixing element (not shown in the figure), a thread body control element 120 and a first auxiliary fixing device 130 .
  • the thread body control member 120 includes a rod portion 122
  • the first auxiliary fixing device 130 includes a needle tube portion 132, a first body portion 134, a first accommodating portion 136, and a first trigger portion 138
  • the first accommodating portion 136 includes a first opening type groove portion 136A.
  • the needle tube part 132 is connected to the first body part 134 , and the first accommodating part 136 and the first trigger part 138 are disposed on the first body part 134 .
  • the wire body 110 has a first end and a second end, the first end of which is connected to the fixing member (for example, the first end of the wire body 110 can be connected to the first fixing member), the second end is connected to the wire body control member 120, and the wire A part of the body 110 is movably disposed on the wire body control member 120 . It should be understood that the second end of the wire body 110 does not need to be fixed on the wire body control member 120 , but can be movably connected or disposed on the wire body control member 120 as required.
  • the wire body 110 is elastic.
  • the wire body 110 and the wire body control member 120 are detachably (or called removable) connected to the first auxiliary fixing device 130 (that is, the wire body 110 can be together with the wire body control member 120 are directly disassembled and removed from the first auxiliary fixing device 130).
  • the first end of the thread body 110 and a part of the thread body 110 are accommodated in the needle tube portion 132, and the thread body control member 120 is connected to the (or installed in) the first accommodating portion 136 of the first auxiliary fixing device 130 .
  • the rod portion 122 of the wire control member 120 is detachably (or referred to as removable) connected to (or accommodated in) the first open groove portion 136A of the first auxiliary fixing device 130 .
  • the needle tube part 132 may have a slot extending on the needle tube part 132 .
  • the thread body 110 can extend from one end of the slot hole to the outside of the needle tube portion 132 and connect to the thread body control member 120 . In this way, a part of the wire body 110 is located outside the first auxiliary fixing device 130 .
  • the fixing member can be placed in the needle tube part 132 of the first auxiliary fixing device 130, and the first auxiliary fixing device 130 has a push-out mechanism, and the first auxiliary fixing device 130 can fix the needle through the pushing-out mechanism.
  • a member (such as a first fixing member or a second fixing member) is pushed outward from the needle tube portion 132, so that the fixing member is fixed on the target spinal ligament.
  • the first auxiliary fixing device 130 pushes the fixing part outward from the needle tube part 132 through the pushing mechanism.
  • the push-out mechanism and/or the first trigger part and/or related mechanisms of the first auxiliary fixing device can be referred to, for example, U.S. Patent No. 10363024B2 (the application number is No. 14/608623, and the invention name is System for meniscal repair using suture implant cinch construct), U.S. Invention Patent Publication No. 10478175B2 (application No. 15/208341, and the name of the invention is Method and apparatus for meniscal repair), U.S. Invention Patent Publication No.
  • 20190343509A1 application No. 16/523382 No., the invention name is System for meniscal repair using suture implant cinch construct
  • U.S. Invention Patent Publication No. 20200069307A1 the application number is No. 16/675927, the invention name is Method and apparatus for meniscal repair
  • Chinese Invention Patent Publication No. No. 112839594A the application number is No. 201980066558.0, and the title of the invention is a system for repairing soft tissue tears
  • the full text of these patents is hereby incorporated by reference.
  • FIG. 2A illustrates a schematic view of a specific embodiment of the wire body and the fixing member of the spinal stabilization system of the present invention.
  • the first fixing member 240 has a first piercing portion 242 and a first connecting portion 244
  • the first connecting portion 244 is provided with a first connecting hole 248 .
  • the second fixing member 250 has a second piercing portion 252 and a second connecting portion 254 , and a second connecting hole 258 is formed on the second connecting portion 254 .
  • the wire body 210 is connected to the first connecting portion 244 of the first fixing member 240
  • the wire body 210 is connected to the second connecting portion 254 of the second fixing member 250 .
  • the first fixing part 240 is connected to the first end 212 of the wire body, and the second fixing part 250 is connected to other positions of the wire body 210 .
  • the first fixing member 240 can puncture and pass through the target spinal ligament through the first puncture part 242 , thereby fixing the first fixing member 240 to the target spinal ligament.
  • the second fixing part 250 can puncture and pass through the target spinal ligament through the second puncture part 252 , thereby fixing the second fixing part 250 to the target spinal ligament.
  • the first auxiliary fixing device can first push out the fixing element (such as the first fixing element) Or the puncture part of the second fixing member) is pushed out to the front end of the needle tube part 232, and the puncture part is exposed to the outside of the needle tube part 232. After the puncture part punctures the target spinal ligament, the fixing part is fully pushed out by the push-out mechanism, so that the fixing part passes through and is fixed on the target spinal ligament.
  • the first fixing part 240 can have a first auxiliary connecting part 246, and the first auxiliary connecting part 246 can pass through the first connecting hole 248 and the wire body 210, so that the first fixing part 240 can be connected to the wire.
  • the second fixing part 250 can have a second auxiliary connecting part 256 , and the second auxiliary connecting part 256 can pass through the second connecting hole 258 and the wire body 210 , so as to connect the second fixing part 250 to the wire body 210 .
  • the way the first fixing part 240 and the second fixing part 250 are connected to the wire body 210 is not limited to that shown in FIG. 2 , and the first fixing part and the second fixing part can also be connected to the wire body in other ways.
  • the wire body can directly pass through the connecting part (such as the first connecting part or the second connecting part) of the fixing part (such as the first fixing part or the second fixing part), and bind the fixing part in a way of winding and/or knotting. connect.
  • the connection method between the wire body and the fixing member can be referred to, for example, the aforementioned US patent and the aforementioned Chinese patent, but is not limited thereto. It should be understood that not only two fixing pieces can be connected to the wire body 210 , but one or more fixing pieces can be connected according to requirements.
  • the wire body 210 can only be connected to the first fixing part 240 at the first end 212 , and the rest of the wire body 210 does not have any fixing parts.
  • the first end of the wire body may be connected with a first fixing member, and a second fixing member may be connected with a plurality of other positions of the wire body respectively.
  • a first fixing member may be connected with a plurality of other positions of the wire body respectively.
  • at least one of the first fixing element and the plurality of second fixing elements is accommodated in the needle tube portion.
  • the fixing part of the target spinal ligament to be punctured is accommodated in the needle tube part.
  • the first fixing part connected to the wire body and each second fixing part may have the same structure.
  • FIG. 2B illustrates a schematic view of a specific embodiment of the fixing member of the spinal stabilization system of the present invention.
  • the fixing member 270 has a piercing portion 272 and a connecting portion 274 , and the connecting portion 274 is provided with a wire connecting hole 271 and connecting holes 278 and 279 .
  • the wire can pass through the wire connection 271 and/or the connection holes 278 , 279 .
  • FIG. 3 which illustrates a schematic diagram of a specific embodiment of fixing the fixing element to the spinal ligament of the spinal stabilization system of the present invention. In the embodiment shown in FIG.
  • the wire body 310 is connected to the first fixing part 340 and the second fixing part 350 .
  • the first fixing member 340 is connected to the first end 312 of the wire body 310 .
  • the first fixing part 340 passes through and is fixed on the target spinal ligament 1500 , and the second puncture part of the second fixing part 350 is exposed outside the needle tube part 332 and punctures the target spinal ligament 1500 .
  • FIG. 4 illustrates a schematic view of a specific embodiment of the wire control member and the first auxiliary fixation device of the spinal stabilization system of the present invention.
  • the thread control member 420 includes rods 422, 424, a thread accommodating portion 426, and a gear portion 428.
  • the thread accommodating portion 426 connects the rods 422, 424, and the thread accommodating portion 426 is connected to the gear part 428 .
  • the first auxiliary fixing device 430 includes a needle tube part 432 , a first body part 434 and a first accommodating part 436 , the needle tube part 432 is connected to the first body part 434 , and the first accommodating part 436 is disposed on the first body part 434 .
  • the needle tube part 432 has a slot hole 437 , and the slot hole 437 is extended on the needle tube part 432 .
  • the thread body can be partially accommodated in the needle tube part 432, and the thread body can extend from the slot hole end 439 of the slot hole 437 toward the outside of the needle tube part 432, and then connect and accommodate Placed (for example, wrapped around) the wire accommodating portion 426 of the wire control member 420 .
  • the first accommodating portion 436 has first open grooves 436A, 436B, and the rods 422, 424 of the wire body control member 420 can be respectively accommodated in the first open grooves 436A, 436B, so that the wire body control member 420 It is connected and accommodated in the first accommodating portion 436 of the first auxiliary fixing device 430 .
  • the gear portion 428 of the wire control member 420 can contact a stop portion on the first accommodating portion 436 (the stop portion can be, for example, a protrusion or an elastic piece, but not limited thereto). In this way, the wire control member 420 can prevent the wire control member 420 from moving relative to the first accommodating portion 436 in a specific direction through the gear portion 428 .
  • the gear part 428 of the wire body control part 420 can prevent the wire body control part 420 from rotating relative to the first accommodating part 436 in a specific direction, thereby preventing the wire body from being wound on the wire body accommodating part 426 Unexpected winding-up of the thread body during the operation (in another specific embodiment, it is to prevent the thread body wound on the thread body accommodating portion 426 from unintended setting-out during the operation).
  • the first auxiliary fixing device 530 includes a needle tube part 532, a first body part 534 and a push rod 536, the needle tube part 532 is connected to the first body part 534, and the first body part 534 has a push rod channel therein 539 , the push rod channel 539 communicates with the inside of the needle tube part 532 .
  • the user can grasp the grip portion 537 of the push rod 536 to control the push rod 536, so that the push rod 536 enters the needle tube portion 532 through the push rod channel 539, and is connected to the fixing member (not shown) of the thread body 510. Push out from the inside of the needle tube part 532 .
  • the spinal stabilization system 600 includes a thread body 610 , a thread body control member 620 and a second auxiliary fixation device 680 .
  • the wire body control part 620 includes a rod portion 622
  • the second auxiliary fixing device 680 includes a second body portion 684, a second accommodating portion 686, a wire body fixing member (not shown) and a second trigger portion 688, and the second accommodating Portion 686 includes a second open groove portion 686A.
  • the second accommodating portion 686 and the second triggering portion 688 are disposed on the second body portion 684 .
  • the second end of the wire body 610 is connected to the wire body control member 620 , and a part of the wire body 610 is movably disposed on the wire body control member 620 .
  • the wire body 610 and the wire body control member 620 are detachably (or called removable) connected to the second auxiliary fixing device 680 (that is, the wire body 610 can be together with the wire body control member 620 are directly disassembled and removed from the second auxiliary fixing device 680).
  • the wire control member 620 is connected (or installed) to the second receiving portion 686 of the second auxiliary fixing device 680 .
  • the rod portion 622 of the wire body control member 620 is detachably (or referred to as removable) connected to (or accommodated in) the second open groove portion 686A of the second auxiliary fixing device 680 . It should be understood that the manner in which the wire control member 620 is connected to the second auxiliary fixing device 680 may be similar or identical to the manner in which the wire control member 620 is connected to the first auxiliary fixing device.
  • the thread body fixing member is arranged inside the second body part 684, and the user can place a part of the thread body in front of the second body part 684, and trigger the second trigger part 688 (the second trigger The part 688 can be regarded as the fixing mechanism of the second auxiliary fixing device 680). And when the user triggers the second trigger part 688, the second auxiliary fixing device 680 will push out (or shoot out) the wire body fixing part from the inside of the second body part 684, and fix the wire body on the wire body fixing part. parts and the target connecting rod.
  • the target connecting rod can be, for example, a connecting rod (Rod) or its peripheral elements for connecting two spinal screws (or called pedicle screws).
  • the connecting rod used to connect two spinal nails and its surrounding elements can refer to the US Invention Patent No. 6368320B1 (the application number is No. 09/581104, and the invention name is Connector for backbone osteosynthesis device), the U.S. Invention Patent No. No. 9949768B2 (application number is No. 15/344952, the name of the invention is Transconnector) and U.S. Invention Patent Publication No. 20170086889A1 (application number is No. 14/864507, the name of the invention is Spinal implant system and method), hereby incorporated by reference These patents are incorporated herein by reference in their entirety.
  • the second auxiliary fixing device may not have a second trigger part, but instead uses a second push rod (the second push rod can be regarded as a fixing mechanism of the second auxiliary fixing device) to move the wire body fixing member toward The second body portion is protruded externally.
  • the structure and ejection mechanism of the second push rod can be similar or identical to the structure and ejection mechanism of the push rod 536 in FIG. 5 .
  • Fig. 7, illustrates the schematic diagram of a specific embodiment of the wire body fixing part of the present invention.
  • the wire body 710 can be fixed between the wire body fixing member 789 and the target connecting rod 1600 by the fixing mechanism of the second auxiliary fixing device.
  • the thread control member 820 includes rods 822 , 824 , a thread accommodating portion 826 and a gear portion 828 .
  • the thread accommodating portion 826 has a middle portion 827 and a thread fixing portion 829 .
  • the wire body accommodating part 826 is connected to the rod parts 822, 824 (it can be considered that the rod part 824 passes through the gear part 828 and connects the wire body accommodating part 826, and can also be regarded as the rod part 824 connected to the gear part 828), and the wire body accommodates
  • the setting part 826 is connected to the gear part 828.
  • the wire body can be sandwiched in the wire body fixing portion 829 of the wire body accommodating portion 826 to prevent the wire body from falling off from the wire body accommodating portion 826 , and the wire body can be wound around the middle portion 827 of the wire body accommodating portion 826 .
  • the rod parts 822, 824 can be accommodated in the first open groove of the first auxiliary fixation device, and the gear part 828 can contact the first accommodating part of the first auxiliary fixation device a first stop.
  • the rod parts 822, 824 can be accommodated in the second open groove of the second auxiliary fixation device, and the gear part 828 can contact the second accommodating part of the second auxiliary fixation device A second stopper.
  • the function of the second stopper may be similar or identical to the function of the first stopper.
  • FIG. 9 illustrates a schematic view of a specific embodiment of the application of the wire body, the fixing element and the wire body fixing element of the spinal stabilization system of the present invention to the target spinal ligament.
  • the first auxiliary fixing device can sequentially fix each fixing member on the line body 910 to positions 991 and 993 on the target spinal ligament 1500 respectively. , 995, 997, 999.
  • the spine stabilization system can fix the thread body 910 between the thread body fixing member 989 and the target connecting rod 1600 by the second auxiliary fixing device in the second use state. Then cut off the excess part of the thread body.
  • the thread body 910 fixed on the target spinal ligament 1500 can help improve the stability of the target vertebra 1700 .
  • the wire body 910 is elastic.
  • the spinal stabilization system 1000 includes a wire body (not shown in the figure), a first fixing member (not shown in the figure) and an auxiliary fixing device.
  • the auxiliary fixing device includes a main body part 1010, a needle tube part 1020, a push rod part 1050 and a control part 1060.
  • the first fixing part is connected to the thread body, and a part of the thread body is set in the needle tube part 1020 (before the first fixing part is not fixed to the target spinal ligament, it can also be set in the needle tube part 1020 along with part of the thread body, so as to waiting to be pushed out of the needle tube part 1020 by the push rod part 1050), and the thread body and the first fixing part can move relative to the needle tube part.
  • the thread body can be elastic.
  • the fixing part can have a piercing part and a connecting part, and the fixing part can connect the wire body through the connecting part.
  • the connection manner between the wire body and the first fixing member can be shown in, for example, referring to FIG. 2A and FIG.
  • the spine stabilization system 1000 can not only include one fixing element, but can include a plurality of fixing elements as required.
  • the spine stabilization system 1000 may include a first fixing element and a plurality of second fixing elements, and the plurality of second fixing elements are respectively connected to wire bodies.
  • the spine stabilization system 1000 at least one of the first fixing member and the plurality of second fixing members is accommodated in the needle tube portion 1020 (for example, it can be arranged at the accommodation space 1810 in front of the push rod portion 1050) . In this way, the user can use the push rod part 1050 to push one of the first fixing part and the plurality of second fixing parts out of the needle tube part 1020, so as to fix the pushed out fixing part on the target spinal ligament.
  • the needle tube part 1020 is connected to the main body part 1010 , and the push rod part 1050 is partially disposed in the needle tube part 1020 , and the push rod part 1050 can move relative to the needle tube part 1020 .
  • the control part 1060 is connected to the push rod part 1050, and the control part 1060 can make the push rod part 1050 move relative to the needle tube part 1020, so as to make the thread body and the fixing part (such as the first fixing part) move relative to the needle tube through the push rod part 1050.
  • Section 1020 moves. In this way, the user can move the push rod part 1050 relative to the needle tube part 1020 through the control part 1060 , and then push the fixing part and/or the thread body out of the needle tube part 1020 through the push rod part 1050 .
  • the control part 1060 has a first thread (as shown in FIG. 10C , the control part 1060 has a first thread 1062 ), and the push rod part 1050 has a second thread 1054 .
  • the control part 1060 can be threadedly connected with the second thread 1054 of the push rod part 1050 through the first thread 1062, and the control part 1060 and the push rod part 1050 can be screwed together so that the push rod part 1050 can move relative to the needle tube part. 1020 moves.
  • the needle tube part 1020 is connected to the main body part 1010
  • the control part 1060 is connected to the main body part 1010
  • the control part 1060 can move relative to the main body part 1010 .
  • FIG. 10A shows that the spine stabilization system 1000 moves the push rod part 1050 toward the control part 1060 through the screwing movement between the control part 1060 and the push rod part 1050 .
  • FIG. 10B depicts that the spinal stabilization system 1000 moves the push rod part 1050 toward the needle tip of the needle tube part 1020 through the screwing movement between the control part 1060 and the push rod part 1050 .
  • the main body part 1010 has a groove part 1012, and the groove part 1012 is extended on the main body part 1010 along the groove extending direction 1820 (or it can be called that the groove part 1012 has a groove extending direction 1820 ).
  • the push rod part 1050 has a groove connection part 1052 , and the groove connection part 1052 is partially disposed in the groove part 1012 . In this way, the push rod part 1050 can move relative to the main body part 1010 along the groove extending direction 1820 through the groove connection part 1052 .
  • the groove connecting portion 1052 may be, for example, a protruding portion protruding outward from the surface of the push rod portion 1050 , but not limited thereto.
  • the auxiliary fixing device includes a thread control member 1040 , the thread control member 1040 is connected to the main body 1010 , and the thread control member 1040 can move relative to the main body 1010 .
  • the fixing part (such as the first fixing part) can be connected to the first end of the wire body, and the second end of the wire body can be connected to the wire body control part 1040, and a part of the wire body can be movably arranged on the On the wire control member 1040 (for example, it can be wound on).
  • a part of the wire body can be wound on the wire body control member 1040 .
  • the wire body control member 1040 can be similar to a wire reel.
  • the line body control part 1040 can be detachably connected to the main body part 1010 of the auxiliary fixing device according to requirements, or the line body control part 1040 can be detachably connected to the main body part 1010 of the auxiliary fixing device according to needs .
  • the needle tube part 1020 may have a slot extending on the needle tube part 1020 .
  • the thread body can extend from the slot hole to the outside of the needle tube part 1020 and connect to the thread body control member 1040 .
  • the thread body may not extend to the outside of the needle tube part 1020 as required.
  • a part of the thread body can also be extended and arranged in the needle tube part 1020 and the main body part 1010 according to requirements, and then extend from the inside of the main body part 1010 to the thread body control part 1040, and be arranged (for example, wound) on the thread body control part 1040 .
  • the needle tube part 1020 may also not have a slot.
  • FIG. 10D illustrates a schematic view of a specific embodiment of the line control member and the second fixing part of the spinal stabilization system of the present invention.
  • the wire body control member 1040 has a first fixing portion 1042 .
  • the auxiliary fixing device includes a second fixing part 1030 , the second fixing part 1030 is disposed on the main body part 1010 , and the second fixing part 1030 can move relative to the main body part.
  • the second fixing portion 1030 when the second fixing portion 1030 is in the first state, the second fixing portion 1030 contacts the first fixing portion 1042, so that the wire control member 1040 cannot move in the first direction 1840 and/or in the second direction opposite to the first direction 1840. It moves relative to the main body 1010 in two directions 1850 . And when the second fixing part 1030 is in the second state, the second fixing part 1030 and the first fixing part 1042 are separated from each other. At this time, the wire body control member 1040 can move relative to the main body 1010 in the first direction 1840 or in the second direction 1850 opposite to the first direction 1840 as required.
  • the first fixing part 1042 is a gear part provided on the wire body control part 1040 .
  • the second fixing part 1030 has a protruding block 1032 . Wherein, when the second fixing part 1030 is in the first state, the protruding block 1032 of the second fixing part 1030 is against the first fixing part 1042, so that the wire body control part 1040 cannot move in the first direction 1840 and/or opposite to the first fixing part 1042. Movement in a second direction 1850 in one direction 1840 relative to the main body portion 1010 .
  • the second fixing part 1030 can be partially disposed outside the main body part 1010, so that the user can conveniently set the second fixing part 1030 in the first state or the second state. It should be understood that the structure and arrangement of the aforementioned stopper, first stopper, and second stopper may be similar to the second fixing part 1030 , but not limited thereto.
  • FIG. 11 illustrates a schematic view of a specific embodiment of the fixing member of the spinal stabilization system of the present invention.
  • the direction of the fixing member 1170 can be adjusted to fix the fixing member 1170 on the target spinal ligament.
  • fixation member 1170 may be rotated in direction 1860 to secure fixation member 1170 to the target spinal ligament.

Abstract

一种脊椎稳定系统(100,600,1000)，包含：线体(110,210,310,510,610,710,910)；第一固定件(240,340)，连接线体(110,210,310,510,610,710,910)；以及辅助固定装置，包含：主体部(1010)；针管部(132,232,332,432,532,1020)，连接主体部(1010)，线体(110,210, 310,510,610,710,910)之一部分设置于针管部(132,232,332,432,532,1020)内，且线体(110,210,310,510,610,710,910)与第一固定件(240,340)可相对于针管部(132,232,332, 432,532,1020)移动；推杆部(1050)，部分设置于针管部(132,232,332,432,532,1020)内，推杆部(1050)可相对于针管部(132,232,332,432,532,1020)移动；以及控制部(1060)，连接推杆部(1050)；其中控制部(1060)使推杆部(1050)相对于针管部(132,232,332,432, 532,1020)移动，借以透过推杆部(1050)而使线体(110,210,310,510,610,710,910)与第一固定件(240,340)相对于针管部(132,232,332,432,532,1020)移动。

Description

脊椎稳定系统 技术领域
本发明系关于一种脊椎稳定系统，特别系关于一种可将辅助线体固定于脊椎韧带上，以增加脊椎稳定性的脊椎稳定系统。
背景技术
传统的脊椎固定系统仅系将复数个骨钉(screw)固定于椎骨，再透过连结杆(rod)将骨钉彼此固定，借以达到将脊椎固定至正确的位置及角度的效果。然而，透过此传统的脊椎固定系统，仅能将设有骨钉的椎骨彼此固定，而对于椎骨与椎骨之间(例如设有骨钉的椎骨与未设置骨钉的椎骨之间)的连动性或相对运动则无法提供任何辅助效果，从而导致脊椎稳定性不足的缺点。有鉴于此，将需要一种可将辅助线体固定于脊椎韧带上，以增加脊椎稳定性的脊椎稳定系统。
发明内容
为了解决上述问题，本发明之一构想在于提供一种可将辅助线体固定于脊椎韧带上，以增加脊椎稳定性的脊椎稳定系统。
基于前揭构想，本发明提供一种脊椎稳定系统，包含：线体，具有线体第一端以及线体第二端；第一固定件，连接于该线体第一端；线体控制件，该线体第二端连接该线体控制件，且该线体之一部分以可移动的方式设置于该线体控制件上；以及第一辅助固定装置，具有针管部以及第一容置部；其中当该脊椎稳定系统处于第一使用状态时，该线体连同该线体控制件可拆卸地连接于该第一辅助固定装置；其中当该脊椎稳定系统处于该第一使用状态时，该线体系部分地容置于该针管部内，且该线体控制件连接该第一辅助固定装置的该第一容置部。
于本发明之一较佳实施例中，该线体具有弹性。
于本发明之一较佳实施例中，该针管部具有槽孔，该槽孔延伸设置 于该针管部上，该线体自该槽孔向该针管部的外部延伸并连接该线体控制件。
于本发明之一较佳实施例中，该线体控制件具有齿轮部，该齿轮部接触该第一容置部，该线体控制件藉由该齿轮部以避免该线体控制件在一特定方向上相对于该第一容置部移动。
于本发明之一较佳实施例中，该线体控制件具有杆部，该第一辅助固定装置的第一容置部具有第一开放式凹槽部；其中当该脊椎稳定系统处于该第一使用状态时，该线体控制件系藉由该杆部而可拆卸地连接该第一辅助固定装置的该第一开放式凹槽部。
于本发明之一较佳实施例中，该第一辅助固定装置具有推出机构，该第一辅助固定装置藉由该推出机构而将该第一固定件自该针管部内向外推出，以使该第一固定件固定于目标脊椎韧带上。
于本发明之一较佳实施例中，该推出机构为该第一辅助固定装置具有推杆以及推杆通道，该推杆通道连通该针管部；其中该推杆经由该推杆通道进入该针管部内，并将该第一固定件自该针管部内向外推出。
于本发明之一较佳实施例中，该脊椎稳定系统进一步包含：复数个第二固定件，该复数个第二固定件分别连接该线体；其中当该脊椎稳定系统处于该第一使用状态时，该第一固定件以及该复数个第二固定件其中至少一者系容置于该针管部内。
于本发明之一较佳实施例中，该第一固定件具有第一穿刺部以及第一连接部，该第一固定件系经由该第一连接部以连接该线体；该复数个第二固定件分别具有第二穿刺部以及第二连接部，该复数个第二固定件分别系经由对应的该第二连接部以连接该线体。
于本发明之一较佳实施例中，该第一辅助固定装置具有推出机构，该第一辅助固定装置藉由该推出机构而将该第一固定件以及该复数个第二固定件其中一者自该针管部内向外推出，以使其固定于目标脊椎韧带上。
于本发明之一较佳实施例中，该脊椎稳定系统进一步包含：第二辅助固定装置，具有第二容置部；其中当该脊椎稳定系统处于第二使用状 态时，该第一固定件固定于目标脊椎韧带上，且该线体连同该线体控制件可拆卸地连接于该第二辅助固定装置；其中当该脊椎稳定系统处于该第二使用状态时，该线体控制件连接该第二辅助固定装置的该第二容置部。
于本发明之一较佳实施例中，该第二辅助固定装置具有线体固定件以及固定机构；该第二辅助固定装置藉由该固定机构以将该线体固定于该线体固定件以及目标连接杆之间。
于本发明之一较佳实施例中，该线体控制件具有杆部，该第二辅助固定装置的第二容置部具有第二开放式凹槽部；其中当该脊椎稳定系统处于该第二使用状态时，该线体控制件系藉由该杆部而可拆卸地连接该第二辅助固定装置的该第二开放式凹槽部。
根据本发明之目的，再提供一种脊椎稳定系统，包含：线体；第一固定件，连接该线体；以及辅助固定装置，包含：主体部；针管部，连接该主体部，该线体之一部分设置于该针管部内，且该线体与该第一固定件可相对于该针管部移动；推杆部，部分设置于该针管部内，该推杆部可相对于该针管部移动；以及控制部，连接该推杆部；其中该控制部使该推杆部相对于该针管部移动，借以透过该推杆部而使该线体与该第一固定件相对于该针管部移动。
于本发明之一较佳实施例中，该控制部具有第一螺纹，该推杆部具有第二螺纹，该控制部藉由该第一螺纹而与该推杆部的该第二螺纹螺合连接；其中该控制部与该推杆部彼此螺合运动，借以使该推杆部相对于该针管部移动。
于本发明之一较佳实施例中，该控制部连接该主体部，且该控制部可相对于该主体部运动。
于本发明之一较佳实施例中，该主体部具有沟槽部，该沟槽部具有沟槽延伸方向；其中该推杆部具有沟槽连接部，该沟槽连接部系部分设置于该沟槽部中；其中该推杆部藉由该沟槽连接部，以沿着该沟槽延伸方向而相对于该主体部移动。
于本发明之一较佳实施例中，该辅助固定装置包含：线体控制件， 连接该主体部，且该线体控制件可相对于该主体部而运动；其中该第一固定件连接该线体的线体第一端；其中该线体的线体第二端连接该线体控制件，且该线体之一部分以可移动的方式设置于该线体控制件上。
于本发明之一较佳实施例中，该针管部具有槽孔，该槽孔延伸设置于该针管部上，该线体自该槽孔向该针管部的外部延伸并连接该线体控制件。
于本发明之一较佳实施例中，该线体控制件具有第一固定部，该辅助固定装置包含：第二固定部，设置于该主体部上，且该第二固定部可相对于该主体部移动；其中当该第二固定部处于第一状态时，该第二固定部接触该第一固定部，借以使该线体控制件无法在第一方向上相对于该主体部而运动；其中当该第二固定部处于第二状态时，该第二固定部与该第一固定部彼此分离。
于本发明之一较佳实施例中，该第一固定部为设置于该线体控制件上的齿轮部。
于本发明之一较佳实施例中，该线体具有弹性。
于本发明之一较佳实施例中，该脊椎稳定系统进一步包含：复数个第二固定件，该复数个第二固定件分别连接该线体；其中该第一固定件以及该复数个第二固定件其中至少一者系容置于该针管部内。
于本发明之一较佳实施例中，该第一固定件具有穿刺部以及连接部，该第一固定件系经由该连接部以连接该线体。
本发明前述各方面及其它方面依据下述的非限制性具体实施例详细说明以及参照附随的图式将更趋于明了。
附图说明
图1为本发明脊椎稳定系统在第一使用状态下的一具体实施例的示意图。
图2A为本发明脊椎稳定系统的线体以及固定件一具体实施例的示意图。
图2B为本发明脊椎稳定系统的固定件一具体实施例的示意图。
图3为本发明脊椎稳定系统的固定件固定于脊椎韧带一具体实施例的示意图。
图4为本发明脊椎稳定系统的线体控制件以及第一辅助固定装置一具体实施例的示意图。
图5为本发明脊椎稳定系统的第一辅助固定装置一具体实施例的示意图。
图6为本发明脊椎稳定系统在第二使用状态下的一具体实施例的示意图。
图7为本发明线体固定件一具体实施例的示意图。
图8为本发明脊椎稳定系统的线体控制件一具体实施例的示意图。
图9为本发明脊椎稳定系统的线体、固定件以及线体固定件施用于目标脊椎韧带一具体实施例的示意图。
图10A为本发明脊椎稳定系统一具体实施例的示意图。
图10B为本发明脊椎稳定系统一具体实施例的示意图。
图10C为本发明脊椎稳定系统的控制部一具体实施例的示意图。
图10D为本发明脊椎稳定系统的线体控制件与第二固定部一具体实施例的示意图。
图11为本发明脊椎稳定系统的固定件一具体实施例的示意图。
附图标记：
100脊椎稳定系统
110线体
120线体控制件
122杆部
130第一辅助固定装置
132针管部
134第一本体部
136第一容置部
136A第一开放式凹槽部 138第一触发部
210线体
212第一端
232针管部
240第一固定件
242第一穿刺部
244第一连接部
246第一辅助连接部248第一连接孔
250第二固定件
252第二穿刺部
254第二连接部
256第二辅助连接部258第二连接孔
270固定件
271线体连接孔
272穿刺部
274连接部
278、279连接孔
310线体
312第一端
332针管部
340第一固定件
350第二固定件
420线体控制件
422、424杆部
426线体容置部
428齿轮部
430第一辅助固定装置
432针管部
434第一本体部
436第一容置部
436A、436B第一开放式凹槽
437槽孔
439槽孔端部
510线体
530第一辅助固定装置
532针管部
534第一本体部
536推杆
537握持部
539推杆通道
600脊椎稳定系统
610线体
620线体控制件
622杆部
680第二辅助固定装置
684第二本体部
686第二容置部
686A第二开放式凹槽部
688第二触发部
710线体
789线体固定件
820线体控制件
822、824杆部
826线体容置部
827中间部
828齿轮部
829线体固定部
910线体
989线体固定件
991～999位置
1000脊椎稳定系统
1010主体部
1012沟槽部
1020针管部
1030第二固定部
1032突出块
1040线体控制件
1042第一固定部
1050推杆部
1052沟槽连接部
1054第二螺纹
1060控制部
1062第一螺纹
1170固定件
1500目标脊椎韧带
1600目标连接杆
1700目标脊椎
1810容置空间
1820沟槽延伸方向
1840第一方向
1850第二方向
1860方向
具体实施方式
请参阅图1，其例示说明了本发明脊椎稳定系统在第一使用状态下的 一具体实施例的示意图。如图1所示实施例，脊椎稳定系统100包含了线体110、固定件(图未示)、线体控制件120以及第一辅助固定装置130。线体控制件120包含杆部122，第一辅助固定装置130包含针管部132、第一本体部134、第一容置部136以及第一触发部138，第一容置部136包含第一开放式凹槽部136A。针管部132连接第一本体部134，第一容置部136以及第一触发部138设置于第一本体部134上。线体110具有第一端以及第二端，其第一端连接固定件(例如线体110的第一端可连接第一固定件)，其第二端连接于线体控制件120，且线体110之一部分以可移动的方式设置于线体控制件120上。应了解，线体110的第二端无须固定于线体控制件120，而系可视需求以可移动的方式连接或设置于线体控制件120上。较佳地，线体110具有弹性。当脊椎稳定系统100处于第一使用状态下时，线体110连同线体控制件120以可拆卸(或称可移除)的方式连接于第一辅助固定装置130(亦即，线体110可连同线体控制件120直接自第一辅助固定装置130拆卸并移除)。在一具体实施例中，当脊椎稳定系统100处于第一使用状态下时，线体110的第一端以及线体110的一部分系容置于针管部132内，且线体控制件120连接于(或装设于)第一辅助固定装置130的第一容置部136。其中，线体控制件120的杆部122可拆卸(或称可移除)地连接于(或容置于)于第一辅助固定装置130的第一开放式凹槽部136A。
在一具体实施例中，针管部132可具有延伸设置于针管部132上的槽孔。线体110可自槽孔的一端部处而向针管部132的外部延伸，并连接线体控制件120。如此，线体110的一部分即位于第一辅助固定装置130的外部。在一具体实施例中，固定件可置放于第一辅助固定装置130的针管部132内，第一辅助固定装置130具有推出机构，第一辅助固定装置130可藉由该推出机构而将固定件(例如第一固定件或第二固定件)自针管部132内向外推出，以使固定件固定于目标脊椎韧带上。在一具体实施例中，当第一辅助固定装置130的第一触发部138被触发时，第一辅助固定装置130及藉由推出机构而将固定件自针管部132内向外推出。第一辅助固定装置的推出机构及/或第一触发部及/或相关机构可例如 参阅美国发明专利公告号第10363024B2号(申请号为第14/608623号，发明名称为System for meniscal repair using suture implant cinch construct)、美国发明专利公告号第10478175B2号(申请号为第15/208341号，发明名称为Method and apparatus for meniscal repair)、美国发明专利公开号第20190343509A1号(申请号为第16/523382号，发明名称为System for meniscal repair using suture implant cinch construct)、美国发明专利公开号第20200069307A1号(申请号为第16/675927号，发明名称为Method and apparatus for meniscal repair)以及中国发明专利公开号第112839594A号(申请号为第201980066558.0号，发明名称为用于修复软组织撕裂的系统)，在此并以引用形式将此些专利之全文列入本文中。
请参阅图2A，其例示说明了本发明脊椎稳定系统的线体以及固定件一具体实施例的示意图。如图2A所示实施例，第一固定件240具有第一穿刺部242以及第一连接部244，第一连接部244上设有第一连接孔248。第二固定件250具有第二穿刺部252以及第二连接部254，第二连接部254上设有第二连接孔258。线体210连接第一固定件240的第一连接部244，且线体210连接第二固定件250的第二连接部254。其中，第一固定件240连接于线体的第一端212，第二固定件250则连接于线体210的其它位置。在一具体实施例中，第一固定件240可藉由第一穿刺部242以穿刺并穿过目标脊椎韧带，并借此将第一固定件240固定于目标脊椎韧带。第二固定件250可藉由第二穿刺部252以穿刺并穿过目标脊椎韧带，并借此将第二固定件250固定于目标脊椎韧带。较佳地，在将固定件(例如第一固定件或第二固定件)固定于目标脊椎韧带的过程中，第一辅助固定装置可先藉由推出机构以将固定件(例如第一固定件或第二固定件)的穿刺部推出至针管部232的前端，并使穿刺部露出于针管部232的外侧。待穿刺部穿刺于目标脊椎韧带后，再藉由推出机构以将固定件全部推出，借此使固定件穿过并固定于目标脊椎韧带。
在一具体实施例中，第一固定件240可具有第一辅助连接部246，第一辅助连接部246可穿过第一连接孔248以及线体210，借以使第一固定件240连接于线体210。第二固定件250可具有第二辅助连接部256， 第二辅助连接部256可穿过第二连接孔258以及线体210，借以使第二固定件250连接于线体210。应了解，第一固定件240以及第二固定件250连接于线体210的方式并非仅限于图2中所示，第一固定件以及第二固定件亦可透过其他方式连接线体。例如线体可直接穿过固定件(例如第一固定件或第二固定件)的连接部(例如第一连接部或第二连接部)，并以缠绕及/或打结的方式与固定件连接。线体与固定件的连接方式可例如参见前述之美国专利以及前述之中国专利，但不以此为限。应了解，线体210上并非仅可连接两个固定件，而系可依需求连接一至多个固定件。例如线体210可仅于第一端212处连接第一固定件240，其余部分则不具有任何固定件。或者线体可于第一端处连接第一固定件，并于线体的其它多个位置处分别连接一个第二固定件。较佳地，当脊椎稳定系统处于第一使用状态时，第一固定件以及复数个第二固定件其中至少一者系容置于针管部内。例如当脊椎稳定系统处于第一使用状态时，待穿刺目标脊椎韧带的固定件系容置于针管部内。较佳地，连接于线体的第一固定件以及各个第二固定件可具有相同的结构。
请参阅图2B，其例示说明了本发明脊椎稳定系统的固定件一具体实施例的示意图。如第图2B所示实施例，固定件270具有穿刺部272以及连接部274，连接部274上设有线体连接孔271以及连接孔278、279。线体可穿过线体连接271及/或连接孔278、279。请参阅图3，其例示说明了本发明脊椎稳定系统的固定件固定于脊椎韧带一具体实施例的示意图。如图3所示实施例，线体310连接第一固定件340以及第二固定件350。其中，第一固定件340连接于线体310的第一端312。第一固定件340穿过并固定于目标脊椎韧带1500，第二固定件350的第二穿刺部露出于针管部332的外侧，并穿刺目标脊椎韧带1500。
请参阅图4，其例示说明了本发明脊椎稳定系统的线体控制件以及第一辅助固定装置一具体实施例的示意图。如图4所示实施例，线体控制件420包含杆部422、424、线体容置部426以及齿轮部428，线体容置部426连接杆部422、424，且线体容置部426连接齿轮部428。第一辅助固定装置430包含针管部432、第一本体部434以及第一容置部436， 针管部432连接第一本体部434，第一容置部436设置于第一本体部434上。针管部432上具有槽孔437，且槽孔437延伸设置于针管部432上。当脊椎稳定系统处于第一使用状态时，线体可部分地容置于针管部432内，线体并可自槽孔437的槽孔端部439朝向针管部432的外部延伸，而后连接并容置于(例如卷绕于)线体控制件420的线体容置部426。第一容置部436具有第一开放式凹槽436A、436B，线体控制件420的杆部422、424可分别容置于第一开放式凹槽436A、436B，以使线体控制件420连接并容置于第一辅助固定装置430的第一容置部436。
线体控制件420的齿轮部428可接触第一容置部436上的一止挡部(止挡部可例如为一凸块或弹片，但不以此为限)。如此，线体控制件420即可藉由齿轮部428以避免线体控制件420在一特定方向上相对于第一容置部436移动。举例而言，线体控制件420的齿轮部428可避免线体控制件420在一特定方向上相对于第一容置部436转动，借此可防止卷绕于线体容置部426上的线体在手术中发生非预期的收线(在另一具体实施例中则系为了防止卷绕于线体容置部426上的线体在手术中发生非预期的放线)。
请参阅图5，其例示说明了本发明脊椎稳定系统的第一辅助固定装置一具体实施例的示意图。如图5所示实施例，第一辅助固定装置530包含针管部532、第一本体部534以及推杆536，针管部532连接第一本体部534，第一本体部534其内具有推杆通道539，推杆通道539连通针管部532的内部。使用者可抓握推杆536的握持部537以控制推杆536，借以令推杆536经由推杆通道539进入针管部532内，并将连接于线体510的固定件(图未示)自针管部532的内部向外推出。
请参阅图6，其例示说明了本发明脊椎稳定系统在第二使用状态下的一具体实施例的示意图。如图6所示实施例，脊椎稳定系统600包含了线体610、线体控制件620以及第二辅助固定装置680。线体控制件620包含杆部622，第二辅助固定装置680包含第二本体部684、第二容置部686、线体固定件(图未示)以及第二触发部688，第二容置部686包含第二开放式凹槽部686A。第二容置部686以及第二触发部688设置于第 二本体部684上。线体610的第二端连接于线体控制件620，且线体610的其中一部分以可移动的方式设置于线体控制件620上。当脊椎稳定系统600处于第二使用状态下时，线体610连同线体控制件620以可拆卸(或称可移除)的方式连接于第二辅助固定装置680(亦即，线体610可连同线体控制件620直接自第二辅助固定装置680拆卸并移除)。在一具体实施例中，当脊椎稳定系统600处于第二使用状态下时，线体控制件620连接于(或装设于)第二辅助固定装置680的第二容置部686。其中，线体控制件620的杆部622可拆卸(或称可移除)地连接于(或容置于)于第二辅助固定装置680的第二开放式凹槽部686A。应了解，线体控制件620连接于第二辅助固定装置680的方式可类似或相同于线体控制件620连接于第一辅助固定装置的方式。
在一具体实施例中，线体固定件设置于第二本体部684的内部，使用者可将线体的一部分置于第二本体部684的前方，并触发第二触发部688(第二触发部688可视为第二辅助固定装置680的固定机构)。而当使用者触发第二触发部688时，第二辅助固定装置680即会将线体固定件自第二本体部684的内部向外推出(或射出)，并将线体固定于线体固定件以及目标连接杆之间。目标连接杆可例如为用于连接两个脊椎骨钉(screw，或称pedicle screw)的连接杆(Rod)或其周边之元件。用于连接两个脊椎骨钉的连接杆及其周边元件可参考美国发明专利公告号第6368320B1号(申请号为第09/581104号，发明名称为Connector for backbone osteosynthesis device)、美国发明专利公告号第9949768B2号(申请号为第15/344952号，发明名称为Transconnector)以及美国发明专利公开号第20170086889A1号(申请号为第14/864507号，发明名称为Spinal implant system and method)，在此并以引用形式将此些专利之全文列入本文中。
在一具体实施例中，第二辅助固定装置可不具有第二触发部，而系改以第二推杆(第二推杆可视为第二辅助固定装置的固定机构)将线体固定件向第二本体部的外部推出。第二推杆的结构及推出机制可类似或相同于前述图5中之推杆536的结构及推出机制。请参阅图7，其例示 说明了本发明线体固定件一具体实施例的示意图。如图7所示实施例，藉由第二辅助固定装置的固定机构，即可将线体710固定于线体固定件789以及目标连接杆1600之间。
请参阅图8，其例示说明了本发明脊椎稳定系统的线体控制件一具体实施例的示意图。如图8所示实施例，线体控制件820包含杆部822、824、线体容置部826以及齿轮部828，线体容置部826具有中间部827以及线体固定部829。线体容置部826连接杆部822、824(可视为杆部824穿过齿轮部828后连接线体容置部826，亦可视为杆部824连接齿轮部828)，且线体容置部826连接齿轮部828。线体可夹置于线体容置部826的线体固定部829，以防止线体自线体容置部826脱落，线体并可缠绕于线体容置部826的中间部827。当脊椎稳定系统处于第一使用状态时，杆部822、824可容置于第一辅助固定装置的第一开放式凹槽，齿轮部828可接触第一辅助固定装置的第一容置部上的一第一止挡部。当脊椎稳定系统处于第二使用状态时，杆部822、824可容置于第二辅助固定装置的第二开放式凹槽，齿轮部828可接触第二辅助固定装置的第二容置部上的一第二止挡部。其中，第二止挡部的功用可类似或相同于第一止挡部的功用。
请参阅图9，其例示说明了本发明脊椎稳定系统的线体、固定件以及线体固定件施用于目标脊椎韧带一具体实施例的示意图。如图9所示实施例，脊椎稳定系统可在第一使用状态时，藉由第一辅助固定装置依序将线体910上的各个固定件分别固定在目标脊椎韧带1500上的位置991、993、995、997、999。接着，脊椎稳定系统可在第二使用状态时，藉由第二辅助固定装置将线体910固定在线体固定件989与目标连接杆1600之间。接着再将线体多余的部分剪掉即可。如此，固定于目标脊椎韧带1500上的线体910即可协助提高目标脊椎1700的稳定性。较佳地，线体910具有弹性。
请参阅图10A以及图10B，其例示说明了本发明脊椎稳定系统一具体实施例的示意图。如图10A以及图10B所示实施例，脊椎稳定系统1000包含线体(图未视)、第一固定件(图未视)以及辅助固定装置。辅助 固定装置包含主体部1010、针管部1020、推杆部1050以及控制部1060。第一固定件连接线体，线体的一部分设置于针管部1020内(在第一固定件未被固定至目标脊椎韧带之前，亦可随着部分线体而被设置于针管部1020内，以等待被推杆部1050推出至针管部1020外)，且线体与第一固定件可相对于该针管部移动。较佳地，线体可具有弹性。较佳地，固定件可具有穿刺部以及连接部，且固定件可经由连接部以连接线体。线体与第一固定件之间的连接方式，可例如参考图2A以及图2B所示，但不以此为限。固定件的实施态样，可例如参考图2A以及图2B所示，但不以此为限。应了解，脊椎稳定系统1000并非仅可包含一个固定件，而系可视需求而包含复数个固定件。例如脊椎稳定系统1000可包含第一固定件以及复数个第二固定件，该复数个第二固定件分别连接线体。在使用脊椎稳定系统1000的过程中，第一固定件以及复数个第二固定件其中至少一者系容置于针管部1020内(例如可设置于推杆部1050前方的容置空间1810处)。如此，使用者即可藉由推杆部1050，以将第一固定件以及复数个第二固定件其中一者推出至针管部1020外，借以将被推出的固定件固定于目标脊椎韧带上。
在图10A以及图10B所示实施例中，针管部1020连接该主体部1010，推杆部1050部分设置于针管部1020内，且推杆部1050可相对于针管部1020移动。控制部1060连接推杆部1050，且控制部1060可使推杆部1050相对于针管部1020移动，借以透过推杆部1050而使线体与固定件(例如第一固定件)相对于针管部1020移动。如此，使用者即可藉由控制部1060以使推杆部1050相对于针管部1020移动，进而透过推杆部1050以将固定件及/或线体推出至针管部1020外。
在一具体实施例中，控制部1060具有第一螺纹(如图10C所示，控制部1060具有第一螺纹1062)，推杆部1050具有第二螺纹1054。控制部1060可藉由第一螺纹1062而与推杆部1050的第二螺纹1054螺合连接，且控制部1060与推杆部1050可彼此螺合运动，以使推杆部1050相对于针管部1020移动。较佳地，针管部1020连接主体部1010，控制部1060连接主体部1010，且控制部1060可相对于主体部1010运动。如此， 即可确保在控制部1060与推杆部1050彼此螺合运动的过程中，推杆部1050会相对于针管部1020移动。图10A即绘视了脊椎稳定系统1000藉由控制部1060与推杆部1050彼此间的螺合运动，而使推杆部1050朝向控制部1060的方向移动。图10B则绘视了脊椎稳定系统1000藉由控制部1060与推杆部1050彼此间的螺合运动，而使推杆部1050朝向针管部1020的针尖处移动。
在一具体实施例中，主体部1010具有沟槽部1012，沟槽部1012沿着沟槽延伸方向1820而延伸设置于主体部1010上(或可称为沟槽部1012具有沟槽延伸方向1820)。推杆部1050具有沟槽连接部1052，沟槽连接部1052部分设置于沟槽部1012中。如此，推杆部1050即可藉由沟槽连接部1052，沿着沟槽延伸方向1820而相对于主体部1010移动。沟槽连接部1052可例如为自推杆部1050的表面向外突出的突出部，但不以此为限。
在一具体实施例中，辅助固定装置包含线体控制件1040，线体控制件1040连接主体部1010，且线体控制件1040可相对于主体部1010而运动。固定件(例如第一固定件)可连接于线体的线体第一端，而线体的线体第二端可连接线体控制件1040，且线体之一部分以可移动的方式设置于线体控制件1040上(例如可卷绕于)。较佳地，线体之一部分可卷绕于线体控制件1040上。如此，线体控制件1040即可类似于线体的卷线器。应了解，线体控制件1040可视需求而以可拆卸的方式连接辅助固定装置的主体部1010，或者线体控制件1040可视需求而以部可拆卸的方式连接辅助固定装置的主体部1010。
在一具体实施例中，针管部1020可具有槽孔，该槽孔延伸设置于针管部1020上。线体可自槽孔向针管部1020的外部延伸并连接线体控制件1040。然应了解，线体亦可视需求不向针管部1020的外部延伸。例如线体之一部分亦可视需求而延伸设置于针管部1020以及主体部1010内，接着自主体部1010内延伸至线体控制件1040，并设置(例如卷绕)于线体控制件1040上。应了解，在线体不朝向针管部1020的外部延伸的此种做法中，针管部1020亦可不具有槽孔。
请同时参阅图10A、图10B与图10D，其中图10D例示说明了本发明脊椎稳定系统的线体控制件与第二固定部一具体实施例的示意图。如图10D所示实施例，线体控制件1040具有第一固定部1042。辅助固定装置包含第二固定部1030，第二固定部1030设置于主体部1010上，且第二固定部1030可相对于该主体部移动。其中，当第二固定部1030处于第一状态时，第二固定部1030接触第一固定部1042，借以使线体控制件1040无法在第一方向1840及/或相反于第一方向1840的第二方向1850上相对于主体部1010运动。而当第二固定部1030处于第二状态时，第二固定部1030与第一固定部1042彼此分离。此时线体控制件1040可视需求而在第一方向1840或相反于第一方向1840的第二方向1850上相对于主体部1010运动。
较佳地，第一固定部1042为设置于线体控制件1040上的齿轮部。第二固定部1030具有突出块1032。其中，当第二固定部1030处于第一状态时，第二固定部1030的突出块1032抵住第一固定部1042，以使线体控制件1040无法在第一方向1840及/或相反于第一方向1840的第二方向1850上相对于主体部1010运动。较佳地，第二固定部1030可部分设置于主体部1010的外部，以令使用者可方便将第二固定部1030设置于第一状态或第二状态。应了解，前述之止挡部、第一止档部、第二止挡部的结构及设置方式可类似于第二固定部1030，但不以此为限。
请参阅图11，其例示说明了本发明脊椎稳定系统的固定件一具体实施例的示意图。如图11所示实施例，当固定件1170穿刺通过目标脊椎韧带后，可调整固定件1170的方向，以将固定件1170固定于目标脊椎韧带上。例如可沿着方向1860旋转固定件1170，以将固定件1170固定于目标脊椎韧带上。
至此，本发明之脊椎稳定系统已经由上述说明及图式加以说明。然应了解，本发明的各个具体实施例仅是做为说明之用，在不脱离本发明申请专利范围与精神下可进行各种改变，且均应包含于本发明之专利范围中。因此，本说明书所描述的各具体实施例并非用以限制本发明，本发明之真实范围与精神揭示于以下申请专利范围。

Claims (24)

  1. 一种脊椎稳定系统，包含：
    线体，具有线体第一端以及线体第二端；
    第一固定件，连接于该线体第一端；
    线体控制件，该线体第二端连接该线体控制件，且该线体之一部分以可移动的方式设置于该线体控制件上；以及
    第一辅助固定装置，具有针管部以及第一容置部；
    其中当该脊椎稳定系统处于第一使用状态时，该线体连同该线体控制件可拆卸地连接于该第一辅助固定装置；
    其中当该脊椎稳定系统处于该第一使用状态时，该线体系部分地容置于该针管部内，且该线体控制件连接该第一辅助固定装置的该第一容置部。
  2. 如权利要求1所述的脊椎稳定系统，其中该线体具有弹性。
  3. 如权利要求1所述的脊椎稳定系统，其中该针管部具有槽孔，该槽孔延伸设置于该针管部上，该线体自该槽孔向该针管部的外部延伸并连接该线体控制件。
  4. 如权利要求1所述的脊椎稳定系统，其中该线体控制件具有齿轮部，该齿轮部接触该第一容置部，该线体控制件藉由该齿轮部以避免该线体控制件在一特定方向上相对于该第一容置部移动。
  5. 如权利要求1所述的脊椎稳定系统，其中该线体控制件具有杆部，该第一辅助固定装置的第一容置部具有第一开放式凹槽部；其中当该脊椎稳定系统处于该第一使用状态时，该线体控制件系藉由该杆部而可拆卸地连接该第一辅助固定装置的该第一开放式凹槽部。
  6. 如权利要求1所述的脊椎稳定系统，其中该第一辅助固定装置具有推出机构，该第一辅助固定装置藉由该推出机构而将该第一固定件自该针管部内向外推出，以使该第一固定件固定于目标脊椎韧带上。
  7. 如权利要求6所述的脊椎稳定系统，其中该推出机构为该第一辅助固定装置具有推杆以及推杆通道，该推杆通道连通该针管部；
    其中该推杆经由该推杆通道进入该针管部内，并将该第一固定件自该针管部内向外推出。
  8. 如权利要求1所述的脊椎稳定系统，进一步包含：
    复数个第二固定件，该复数个第二固定件分别连接该线体；
    其中当该脊椎稳定系统处于该第一使用状态时，该第一固定件以及该复数个第二固定件其中至少一者系容置于该针管部内。
  9. 如权利要求8所述的脊椎稳定系统，其中该第一固定件具有第一穿刺部以及第一连接部，该第一固定件系经由该第一连接部以连接该线体；该复数个第二固定件分别具有第二穿刺部以及第二连接部，该复数个第二固定件分别系经由对应的该第二连接部以连接该线体。
  10. 如权利要求8所述的脊椎稳定系统，其中该第一辅助固定装置具有推出机构，该第一辅助固定装置藉由该推出机构而将该第一固定件以及该复数个第二固定件其中一者自该针管部内向外推出，以使其固定于目标脊椎韧带上。
  11. 如权利要求1所述的脊椎稳定系统，进一步包含：
    第二辅助固定装置，具有第二容置部；
    其中当该脊椎稳定系统处于第二使用状态时，该第一固定件固定于目标脊椎韧带上，且该线体连同该线体控制件可拆卸地连接于该第二辅助固定装置；
    其中当该脊椎稳定系统处于该第二使用状态时，该线体控制件连接该第二辅助固定装置的该第二容置部。
  12. 如权利要求11所述的脊椎稳定系统，其中该第二辅助固定装置具有线体固定件以及固定机构；该第二辅助固定装置藉由该固定机构以将该线体固定于该线体固定件以及目标连接杆之间。
  13. 如权利要求11所述的脊椎稳定系统，其中该线体控制件具有杆部，该第二辅助固定装置的第二容置部具有第二开放式凹槽部；其中当该脊椎稳定系统处于该第二使用状态时，该线体控制件系藉由该杆部而可拆卸地连接该第二辅助固定装置的该第二开放式凹槽部。
  14. 一种脊椎稳定系统，包含：
    线体；
    第一固定件，连接该线体；以及
    辅助固定装置，包含：
    主体部；
    针管部，连接该主体部，该线体之一部分设置于该针管部内，且该线体与该第一固定件可相对于该针管部移动；
    推杆部，部分设置于该针管部内，该推杆部可相对于该针管部移动；以及
    控制部，连接该推杆部；
    其中该控制部使该推杆部相对于该针管部移动，借以透过该推杆部而使该线体与该第一固定件相对于该针管部移动。
  15. 如权利要求14所述的脊椎稳定系统，其中该控制部具有第一螺纹，该推杆部具有第二螺纹，该控制部藉由该第一螺纹而与该推杆部的该第二螺纹螺合连接；
    其中该控制部与该推杆部彼此螺合运动，借以使该推杆部相对于该针管部移动。
  16. 如权利要求14所述的脊椎稳定系统，其中该控制部连接该主体部，且该控制部可相对于该主体部运动。
  17. 如权利要求14所述的脊椎稳定系统，其中该主体部具有沟槽部，该沟槽部具有沟槽延伸方向；
    其中该推杆部具有沟槽连接部，该沟槽连接部系部分设置于该沟槽部中；
    其中该推杆部藉由该沟槽连接部，以沿着该沟槽延伸方向而相对于该主体部移动。
  18. 如权利要求14所述的脊椎稳定系统，其中该辅助固定装置包含：
    线体控制件，连接该主体部，且该线体控制件可相对于该主体部而运动；
    其中该第一固定件连接该线体的线体第一端；
    其中该线体的线体第二端连接该线体控制件，且该线体之一部分以 可移动的方式设置于该线体控制件上。
  19. 如权利要求18所述的脊椎稳定系统，其中该针管部具有槽孔，该槽孔延伸设置于该针管部上，该线体自该槽孔向该针管部的外部延伸并连接该线体控制件。
  20. 如权利要求18所述的脊椎稳定系统，其中该线体控制件具有第一固定部，该辅助固定装置包含：
    第二固定部，设置于该主体部上，且该第二固定部可相对于该主体部移动；
    其中当该第二固定部处于第一状态时，该第二固定部接触该第一固定部，借以使该线体控制件无法在第一方向上相对于该主体部而运动；
    其中当该第二固定部处于第二状态时，该第二固定部与该第一固定部彼此分离。
  21. 如权利要求19所述的脊椎稳定系统，其中该第一固定部为设置于该线体控制件上的齿轮部。
  22. 如权利要求14所述的脊椎稳定系统，其中该线体具有弹性。
  23. 如权利要求14所述的脊椎稳定系统，进一步包含：
    复数个第二固定件，该复数个第二固定件分别连接该线体；
    其中该第一固定件以及该复数个第二固定件其中至少一者系容置于该针管部内。
  24. 如权利要求14所述的脊椎稳定系统，其中该第一固定件具有穿刺部以及连接部，该第一固定件系经由该连接部以连接该线体。
PCT/CN2022/142489 2022-01-03 2022-12-27 脊椎稳定系统 WO2023125567A1 (zh)

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