KR20080059219A - Apparatus and methods for vertebral augmentation - Google Patents

Abstract

The apparatus comprises elongated members (2200) which are inserted into vertebrae and secured to an arcuate fixation rod (2300) by clamps (2400) which when moved along the rod cause the elongated members and attached vertebrae to pivot. The method may further include passing through a cannula (2100) and into the a damaged vertebra a disruption tool for fracturing the damaged vertebral body. Once the cortical bone is broken or otherwise disrupted, the height of the damaged vertebral body may be restored, for example by removing the disruption tool and inserting through the cannula another tool, implant, device and/or material to restore the height of the vertebral body and to restore normal spinal curvature in the affected area. Grafting material or filler may be added with or without an implanted device to augment the damaged vertebral body.

Description

Apparatus and Methods for vertebral augmentation

TECHNICAL FIELD The present invention relates to surgical implants, and more particularly, to minimally invasive devices and methods for augmenting vertebrae and restoring vertebrae lordosis.

Spine compression fractures, as shown in FIG. 1, generally exhibit normal spinal injury and may result in chronic disability. These fractures involve the collapse of one or more vertebral bodies 12 in the spine 10. Compression fractures of the spine usually occur in the lower vertebra of the thoracic vertebra or in the upper vertebra of the lumbar spine. They usually involve fractures of the anterior region 18 (as opposed to posterior 16) of the injured vertebrae 12. Spinal compression fractures can result in normal alignment or curvature of the vertebrae of the damaged regions of the spine, such as spinal lordosis. Spinal compression fractures and / or related spinal deformations may result from trauma, such as metastatic diseases of the spine, or may be associated with osteoporosis. To date, doctors have been limited to methods of treating deformations associated with such compression fractures. The only options available were pain medications, long-term recreation, bracing or invasive surgery.

More recently, minimally invasive surgical procedures have been developed for the treatment of spinal compression fractures. These procedures are generally associated with the insertion of a hard cannula, needle or trocar inserted into the front of the collapsed or damaged vertebral body. The cannula may comprise a lumen or other central passage through which other tools, implants, or filler material may pass through to reposition and / or augment the vertebral body. A conventional approach forward to the vertebral body is from the posterior side, for example, via either or both of the pedicles as shown in FIG. 2.

The greatest principle of these procedures, literally means fixing the vertebral body, and can be done without first repositioning the bone. In brief, the cannula or special bone needles slowly pass through the back flexible tissues. Imaging guided x-rays along the small amount of x-ray dye allows the position of the needle to be visible at any time. Small amounts of polymethylmethacrylate (PMMA) or other surgical cement are pushed through the needle into the vertebral body. PMMA is a medical grade material that has been used for a long time in various surgical procedures. As a rule, cement is mixed with antibiotics to reduce the risk of infection and with powders containing barium or tantalum that allow it to be seen on x-rays.

Vertebroplasty is effective in reducing or alleviating fracture pain, preventing further collapse, and restoring mobility of the patient. However, this procedure may not conquer fractured bones and therefore may not cause problems with spinal deformation resulting from fractures. As a rule, it is not performed except in cases where the kyphosis between adjacent vertebral bodies of the damaged area is less than 10%. In addition, this procedure requires high-pressure cement injection with low-viscosity cement, and recent studies have shown that it can cause 30-80% cement leakage. In most cases, cement leakage is harmless. In rare cases, however, polymethmethacrylate or other cement leaks into the vertebral conduit or venous system around the vertebrae, leading to pulmonary embolism and death of the patient.

Some of the more advanced therapies for vertebral compression fractures generally include two steps: (1) conquest or recovery of the initial height of the vertebral body and correction of lordosis of concomitant spinal curvature; And (2) augmentation or addition of materials to support or strengthen fractured bones. Like spinal surgery, such procedures are generally associated with the use of cannula, catheter, needle, trocar or other guide conduit that provides access to the front of the damaged vertebral body.

For example, one such treatment, balloon kyphoplasty (Kyphon, Inc), is described in FIGS. 3A-3D. A catheter with an inflatable balloon tip is a central region of the fractured vertebral body with relatively flexible spongy bones surrounded by fractured cortical bones through cannulas, sheaths or other guide conduits. Inserted into the stomach (FIG. 3A). Balloon angioplasty then inflates the balloon that is inflated to restore it to its original height inside the vertebral body to perform reconstruction, i.e., normal curvature, of vertebral lordosis (Figure 3b). The balloon is then removed to leave a void inside the vertebral body, and the PMMA or other filler material, such as, for example, bone cement, is injected into the void through the cannula, as described above with respect to spinal surgery. (FIG. 3C). The cannula is removed and the cement is treated to augment, fill or fix the bone (FIG. 3D).

Disadvantages of this procedure are high cost, which can impair the reduction of the endplate of the vertebral body after removal of the balloon catheter, and the possibility of perforation of the vertebral endplates during the procedure. As with the debridement, though sparse but perhaps the most frightening thing is balloon complications associated with the leakage of bone cement. For example, neurologic deficit can result from the leakage of bone cement into the spinal canal. Such cement leakage can occur through low-resistance veins of the vertebral body or through cracks in bone that have not been previously evaluated. Other complications include additional proximal levels of vertebral fractures, infections, and cement embolization. Cement embolization is caused by a mechanism similar to cement leakage. Cement can penetrate into low-low venous systems and travel through the lungs or brain, causing pulmonary embolism or stroke. Additional details regarding balloon angioplasty can be found, for example, in US Pat. Nos. 6,423,083, 6,248,110 and 6,235,043 (Riley et al), each of which is hereby incorporated by reference in its entirety. have.

Another approach for the treatment of vertebral composite fractures provides for minimally invasive delivery of cement or allografts or autologous grafts using an inflatable mesh bag, or containment device, within the associated vertebral body. Optimesh system (Spineology, Inc., Stillwater, MN). The pouch or graft remains inside the vertebral body after inflation to prevent any loss during such reduction operations that may occur during balloon spinal surgery when the balloon is withdrawn. However, a disadvantage of this system is that the mesh implant does not integrate well into the vertebral body. This can lead to relative motion between the implant and the vertebral body, resulting in loss after conquest surgery. In addition, the system is complex and relatively expensive. Additional details relating to this procedure are disclosed, for example, in US Patent Publication No. 20040073308, which is incorporated herein by reference in its entirety.

Another procedure used to treat vertebral compression fractures is an expandable polymer augmentation mass known as the SKy Bone Expander. Such a device can be extended to a cube or trapezoidal configuration of a pre-designed size in a controlled manner. Like a Kyphon balloon, once the proper vertebral height and voids are obtained, the SKy Bone Expander is removed and PMMA cement or other filler is injected into the void. Thus, this procedure involves many of the same disadvantages and deficiencies described above with respect to balloon spinal surgery.

Thus, a common disadvantage of most known systems and procedures for the reduction and augmentation of injured vertebrae is that they use relatively complex devices that are introduced through rigid guideways. Rigid guideways may damage the pedicle and / or adjacent tissues during insertion and / or manipulation of the augmentation device. Accordingly, there is a need to provide a safe and effective minimally invasive reduction and augmentation apparatus and method for vertebral lordosis of the spine.

However, regardless of the type of implant or method of augmentation used, such treatment of a collapsed or fractured vertebral body must be performed within approximately 6 weeks of injury. Otherwise, fractured bones tend to heal them in their collapsed state, making it difficult or impossible to repair vertebral lordosis or conquer damaged vertebral bodies without initially tearing the inappropriately healed fracture. Also, due to the generally close proximity of other sensitive and flexible tissues to nerves, blood vessels, and spine, any methods for tearing damaged areas of collapsed vertebral bodies should be minimally invasive and controlled to avoid damaging such surrounding tissues. .

The present invention provides an apparatus and method for minimally invasive vertebral augmentation and restoration of vertebrae lordosis. In one embodiment, the cannula includes a rigid member having a rigid tubular member sized to pass through the tool, and a flexible member having a flexible tubular member. The flexible member is connected to the rigid member such that the tube of the rigid member and the tube of the flexible member form a passage through which the tool can pass.

In another embodiment, the tool used for chiropractic has at least two body segments, each body segment connecting the distal end and the proximal end and the distal end of the first body segment to the proximal end of the adjacent body segment. Having at least one joint, the joints allow the body segments to be articulated with respect to each other. The tool further has an elongate flexible element attached to the distal end of one body segment, the elongate element extending along the length of at least two body segments. When the elongate element is pulled toward the proximal end of the body segment, the proximal body segment is articulated with respect to the adjacent body segment.

In yet another embodiment, the vertebral reduction device has at least one elongate member having a first end and a second end, respectively, and the first end of each elongate member is inserted into the vertebral body. It is composed. The apparatus further comprises an anchoring rod having an arc shape, and at least one clamp configured to adjustably fix the second end of any one elongate member to the anchoring rod. The clamp is configured to move along a stationary rod that pivots the elongated member to conquer the vertebral body.

The present invention also provides bent instruments and implants that can penetrate the cannulaes of the present invention and into the bone or other body parts, such as the damaged vertebrae. Such implants can be used, for example, to conquer endplates of an injured vertebral body and / or to augment the vertebral body.

The cannula and / or flexion tools of the present invention can be used with other devices and methods. For example, after conquering the vertebral body using a flexure tool applied through a partially flexible cannula, one or more implants may be inserted into the vertebral body to further augment the vertebral body. One or more other tools and devices may also be used in external fixation devices to assist in the conquest of the vertebrae adjacent to the collapsed vertebrae, for example, to reduce the compressive force applied to the vertebrae.

The cannula and conquest rods of the present invention may be provided with a biocompatible material having the necessary properties such as, for example, a biocompatible polymer, metal, ceramic, nitinol, PEEK, composites or any combination thereof. In some embodiments, the cannula and / or reduction rod or other implant or tool may be resorbable.

In some embodiments, a method of treating an injured vertebral body includes restoring vertebral lordosis in an area of the injured vertebral body, crushing the injured vertebral body, restoring the height of the injured vertebral body, and augmenting the vertebral body. do.

In another embodiment, the kit has various combinations of assemblies and parts. The kit may include, for example, one or more tools and / or implants for restoring the height of the cannula and vertebral body and / or for augmenting the vertebral body according to the present invention. For example, the kit may include a rigid member, a flexible member associated with the rigid member, and a bending tool for restoring the height of the vertebral body. Other kits may include other implants instead of or in addition to the flexure tool. In other embodiments, the kit may have a cannula, an external fixation or tension member, and / or a longitudinal fixation member. Such embodiments may also have a syringe or other device for injecting cement or other filler into the vertebral body.

The invention and other improvements and features of the invention are described in more detail in the accompanying illustrative drawings. BRIEF DESCRIPTION OF THE DRAWINGS The present invention may be better understood with reference to the accompanying drawings, wherein like reference numerals denote like elements. The drawings are merely illustrative to illustrate specific features that may be used independently or in conjunction with other features and the invention is not limited to the illustrated embodiments.

1 is a diagram illustrating a spine having a vertical compression fracture of one vertebral body.

2 is a view for explaining the spine showing the posterior surgery through the pedicle.

3A to 3D are views illustrating the prior art of a method for treating vertebral compression fractures.

Figure 4 is a flow chart of a method of repairing and vertebral body augmentation of vertebrae lordosis according to an embodiment of the present invention.

Figure 5 is a perspective view of an external fixation device for use in the spine according to an embodiment of the present invention.

6 is a side view of the external fixing device of FIG. 5.

7 is a schematic side view illustrating a cannula inserted into a vertebral body according to the method of the present invention.

8 is a schematic side view for illustration of the cannula of FIG. 7 used for vertebral conquest.

9 is a perspective view of an external anchor for use with a model spine.

10 is an enlarged perspective view of the fixing rod according to the embodiment of the present invention.

11 is a side view of the clamp fixed to the fixing rod according to the embodiment of the present invention.

12 is a side cross-sectional view of the clamp of FIG. 11.

13A and 13B are schematic side views illustrating the operation of the clamp and retaining rod of FIG. 11.

FIG. 14 is a perspective view of a fixing device including the clamp and the fixing rod of FIG. 11.

15 is a perspective view of a fixing device having elongated members crossing each other.

FIG. 16 is a perspective view of a fastening device having elongated members crossing each other from an angle different from that of FIG. 15.

17 depicts an adjustable gliding mechanism.

18 depicts another embodiment of an adjustable gliding mechanism.

19 depicts an alternative device for vertebral restoration.

20 is a side view of a disruption device inserted into a vertebrae in accordance with an embodiment of the present invention.

21 is a plan view of two grinding apparatuses inserted into the vertebrae in accordance with an embodiment of the present invention.

22A is an enlarged plan view of the grinding devices and the vertebra of FIG. 16.

22B is an enlarged side view of the grinding devices and the vertebra of FIG. 21.

23 is a perspective view of the spine illustrating the insertion of the cannula from the posterior side of the spine into the vertebrae.

24 is a schematic cross-sectional side view of a grinding device and cannula according to an embodiment of the present invention.

25 is a side view of the grinding device inserted into the vertebrae in accordance with an embodiment of the present invention.

26 is a plan view of the grinding apparatus inserted into the vertebrae in accordance with an embodiment of the present invention.

27 is a side view of the grinding device inserted into the vertebrae in accordance with an embodiment of the present invention.

28 is a schematic side view of a striking tool and two grinding devices inserted into a vertebrae in accordance with an embodiment of the present invention.

29 is a side view of a grinding device inserted into the vertebrae, showing an axis of motion in accordance with an embodiment of the present invention.

30 is a schematic top view of grinding device tips in accordance with various embodiments of the present invention.

31A and 31B are plan views of other device tips in accordance with an embodiment of the present invention.

32A and 32B are end perspective views of two device tips in accordance with an embodiment of the present invention.

33 is a schematic side view illustrating an apparatus and method for grinding a fractured vertebral body.

34 is a schematic side view illustrating a fractured vertebral body.

35A-35D are schematic side views illustrating a method of restoring the height of a fractured vertebral body.

36 is a plan view of a cannula inserted into a vertebrae in accordance with an embodiment of the present invention.

FIG. 37 is an enlarged plan view of the cannula of FIG. 36.

38 is a schematic cross-sectional plan view of a cannula in accordance with an embodiment of the present invention.

39 is a schematic cross-sectional side view of a cannula in accordance with another embodiment of the present invention.

39 is a cross-sectional side view of a cannula in accordance with another embodiment of the present invention.

40 is a plan view illustrating a rigid member of a cannula according to an embodiment of the present invention.

41A and 41B are cross-sectional side views schematically showing the rigid member and rod of a cannula according to an embodiment of the present invention.

42A and 42B are cross-sectional side views schematically illustrating the cannula and rods used in the vertebrae in accordance with an embodiment of the present invention.

43 is a perspective view illustrating various shapes of tools or implants that may be used in accordance with an embodiment of the present invention.

FIG. 44 is a side view illustrating various curvatures of tools or implants that may be used in accordance with an embodiment of the present invention. FIG.

45 is a cross-sectional side view showing a cannula and an enhancement rod in accordance with another embodiment of the present invention.

46 is a cross-sectional side view of a needle and catheter positioned through a cannula in accordance with the present invention.

47A-47C are perspective views of devices that can be adapted to deliver vertebral filler material in accordance with embodiments of the present invention.

48 is a side view schematically illustrating an apparatus for augmenting the vertebral body with a filler material.

49 is a perspective view of an embodiment of the tool of the present invention.

50 is a perspective view of a cannula inserted through the pedicle of a fractured vertebral body.

FIG. 51 is a perspective view of the tool described in FIG. 49 inserted into the cannula of FIG. 50.

52 is a perspective view of the tool described in FIG. 49 with its front end raised;

53 is a perspective view of the vertebral body restored to its initial height.

54 is a perspective view of a mechanism for pulling the wire of the tool depicted in FIG. 49.

55 is a perspective view of another exemplary embodiment of a mechanism for pulling the wire of the tool depicted in FIG. 49.

56 is a perspective view of another exemplary embodiment of a mechanism for pulling the wire of the tool shown in FIG. 49.

57A-57C are perspective views of other exemplary embodiments of the tool of the present invention.

58A and 58B are perspective views of an exemplary embodiment of ball joints of the tool described in FIG. 49.

59 is a perspective view of another exemplary embodiment of the tool of the present invention.

60 is another perspective view of an exemplary embodiment of the tool of the present invention.

For example, to treat vertebral compression fractures, a method 1000 for repairing vertebral lordosis and augmenting the vertebral body will be described (see FIG. 4). In general, method 1000 may include inserting one or more cannula into an injured vertebral body and / or into a vertebral body adjacent to an injured vertebral body, as follows. Step 1100 may be performed from the rear approach. Step 1200 includes conquering the vertebrae using a cannula. Step 1200 may be performed with an external fixation device. Step 1300 mills the fractured bone in the injured vertebra. Step 1400 restores the vertebral body height, and step 1500 augments the restored vertebral body using, for example, an implant or filler material. Some or all of the steps 1100, 1200, 1300, 1400 and / or 1500 of the method 1000 may be performed in the order shown in FIG. 4, or in any other order, or may be used with other methods. Details and examples related to the respective steps 1100, 1200, 1300, 1400 and 1500 of the method 1000 are described in more detail below.

Cannula  Insert (step 1100)

7 illustrates inserting cannula 2100 into injured vertebrae 12b. Other elongated members 2200, identical or similar to cannula 100 described later, can be used, for example, in step 1100 of FIG. 4. For example, cannula 2100 may be inserted into a fractured or damaged vertebral body 12b and one or more members 2200 may be inserted or attached into vertebrae 12a and 12c, which may be above and / or below the damaged vertebral body 12b. Can be. One or more elongate members 2200 may be cannula.

The dimensions of the one or more elongate members 2200 and / or cannula 2100 may be the same or different, for example having a diameter between about 2 mm and about 10 mm. The elongated member 2200 and / or cannula 2100 may be dimensioned to extend out of the vertebrae and surrounding flexible tissue and may have any required length between about 10 cm and about 30 cm, for example. The elongate member 2200 may comprise stainless steel, metal, metal alloy, polymer, composite, ceramic, or a combination thereof.

The elongated members 2200 and cannula 2100 may be configured to insert into the central region 50 of the vertebrae, such as vertebral body 12, from posterior access through the pedicle 24. When inserted, the elongated members 2200 and cannula 2100 extend out of the vertebrae through the flexible tissue surrounding the spine 10 and out of the patient. In some embodiments, each elongate member 2200 and / or cannula 2100 may be formed through the lateral cortical bone of vertebrae 12, eg, via pedicle 24, eg, by a drill, trocar, or other tool. It can be inserted into the vertebral body through the opening. In some embodiments, the elongated members 2200 may include an external thread (not shown) on the outer surface that engages the vertebral bodies 12a and 12c to secure the elongated members 2200 therein. The outer threads may be formed along the distal portion 2210 of the elongated member 2200, along the entire length of the elongated member 2200, or along any necessary portion of the elongated member 2200. A handle (not shown) may be attached to the proximal end 2220 of the elongate member 2200 and may be used to manipulate and / or insert members 2200 through pedicle 24.

The elongated members 2200 and cannula 2100 can have dimensions that extend out of the vertebrae and surrounding flexible tissue. Member 2200 may be, for example, a cannula such as cannula 2100, or may be attached or combined with other types of cannula, trocar rod, guide conduit, wire, pin or vertebrae 12 to impart force to conquer the vertebrae. Other devices as appropriate. The cannula 2100 and / or the elongate member 2200 may be cylindrical or any other shape, through which provides access to tools, implants, fillers or other materials or devices that can be inserted into the vertebral body 12. Lumens 2110 and 2230 may be included, respectively. The elongate member 2200 may be rigid or hollow and may be semi-rigid or substantially rigid, for example, to impart torque or other force to the vertebrae to which the elongate member 2220 is attached.

See discussion of cannula 100 for additional details of cannula 2100 and / or elongate member 2200.

Vertebrae  Conquest (Step 1200)

In step 1200, the fixation device can be used to help conquer the vertebrae. 5 and 6 illustrate an anchoring device 3000 for positioning, anchoring and / or stabilizing bones, such as vertebrae 12 of vertebrae 10. The device 3000 can be used, for example, in the region of the fractured vertebral body 12 to force the vertebral body 12 to conquer the vertebral bodies 12 and to correct the lordosis of the vertebrae 10. The fixation device 3000 can be applied to other areas of the skeletal structure that conquers damaged or diseased bones.

The apparatus 3000 has one or more elongated members 2200, one or more longitudinal (fixed) members 2300 and one or more clamps 2400 for securing the elongated members 2200 to the fixing members 2300. can do. In some embodiments, the aperture 60 may be formed through the outer cortical bone of vertebrae 12, for example through pedicle 24, such as by a drill, trocar or other tool. Handle 2500 may be attached to the proximal end of elongate member 2200 and may be used to manipulate member 2200 and / or insert members 2200 through pedicle 24.

Optionally, one or more cannula 2100 can be incorporated into, attached to, or used with the device 3000. For example, cannula 2100 may be inserted into a fractured or otherwise damaged vertebral body 12, and one or more members 2200 may be inserted into or otherwise attached to vertebral 12 above and / or below the damaged vertebral body 12. have. Members 2200 can strengthen the vertebral structure as it can be used as a Cimet injection cannula for prophylactically performing chiroplasty above and / or below the vertebrae. In addition, cement injection into the vertebrae above and / or below the damaged vertebrae and cement inside the cannula can enhance the mechanical properties of the segment in subsequent conquests using external forces.

The longitudinal member 2300 may be arched and may have a radius of curvature that substantially corresponds to the distance between the entry point of the member 2200 in the vertebral body and the handle 2500 of the members 2200. The longitudinal member 2300 may also have any desired length and curvature.

One or more clamps 2400 may secure each elongate member 2200 to the longitudinal member 2300. Each clamp 2400 may be adjustable relative to the elongate member 2200 and / or the longitudinal member 2300, for example, to secure the member 2200 to any desired orientation in the longitudinal member 2300. With one end of each elongate member 2200 inserted or attached into the vertebral body 12 and the other end of each member 2200 fixed to the longitudinal member 2300 by clamp 2400, the positions of the members 2200 are stabilized or fixed relative to each other. Can be.

7 shows members 2200 inserted into vertebral bodies 12a and 12c and which may or may not be cannula. Distal end 2210 of each member 2200 may be inserted into the central region 50 of vertebral bodies 12a and 12c, for example. The members 2200 may have a tube 2230 through which cement, bone chips, or other filler can be inserted, for example, into the vertebral bodies 12a and 12c. Such cement, bone needles or other fillers can be used, for example, to help secure members 2200 inside vertebral bodies 12a and 12c.

As shown in FIG. 7, cannula 2100 has a distal end 2120 inserted into collapsed vertebral body 12b. The cannula may comprise a tube 2110 through which a tool, implant, cement, bone chips or other filler can be passed and inserted into the vertebral body 12b, for example, to augment and / or stabilize the damaged vertebral body. The elongated members 2200 may be inserted into one or more vertebrae 12a and 12c, which may be adjacent to the injured vertebral body 12b, as shown in FIG.

FIG. 8 illustrates a method of conquering vertebral bodies 12a-c to recover normal flexion, or lordosis, for example, in the region of the injured vertebrae 12b before augmenting or stabilizing the fractured vertebral body 12b. The distal end 2220 of the members 2200 can adjustably engage the securing member 2300 using, for example, a clamp 2400, thus allowing the members 2200 to be fixed or conquered with respect to each other. The end 2130 of the cannula 2100 may also be attached to the fixation member 2300 by, for example, a clamp 2400 to stabilize and fix the position of the vertebrae while conquering the vertebrae 12a. The end 2220 of the elongate member 2200 fixed to the vertebrae 12a may be moved along the longitudinal member 2300 in the direction shown by arrow 2700, for example. Such movement may cause the elongated member 2200 to rotate about the center of rotation 2600 and impart moment or torque to the vertebral body, which may be easy to conquer vertebral body 12a, for example, to restore normal meditation of the vertebrae 10.

For example, conquest of vertebral body 12a or 12c adjacent to fractured vertebral body 12b may reduce compressive force on vertebral body 12b and increase or restore vertebral height using, for example, tools, implants, fillers, and the like. Can help. In other embodiments, other rotational or moving forces may be applied to the vertebral bodies using one or more members 2200. For example, to orient or position one or more vertebral bodies 12 into the required alignment, member 2200 can be pushed or pulled transversely about vertebrae 10, for example in lieu of or in addition to rotation about pivot 2600. In some embodiments, cannula 2100 is not secured to securing member 2300. FIG. 14 shows the clamp of FIG. 11 with the elongated members of the vertebrae 12a, 12c in different directions along a stationary rod that temporarily restores vertebral alignment to facilitate restoration of the vertebrae 12b. A perspective view of a fixing device including a fixing rod is shown.

FIG. 9 depicts an embodiment of an apparatus 3000 showing members 2200 that can be inserted into the vertebrae of vertebrae 10, secured to one or more fastening members 2300, and can have an arc shape. Members 2200 may be secured to fixing members 2300 using clamp 2400, which may be, for example, standard fixing clamps known in the art. Handle 2500 in each member 2200 can be used to insert and / or manipulate members 2200.

FIG. 10 is a side view of a rod 900 that may be used as the longitudinal member 2400, for example, to secure the members 2200 and / or cannula 2100 in the required position. Rod 900 is a sawtooth or scallops, for example, to allow for one-way 920 movement of the clamp or other device (eg, clamp 4000 in FIG. 11) but not for movement in the opposite direction 930. It may include a ridge or notch 910, which may be a pattern.

11 and 12 show side views of selectively engageable clamps 4000 that may be used, for example, with rod 900 instead of clamp 2400. The clamp 4000 may have a first region 4100 configured to selectively engage the rod 900 and a second region 4200 configured to adjustably engage with a cannula or other elongate member that can engage the first region and be secured to the vertebral body. have. The selectively engageable first region 4100 may include, for example, a housing 4110 having an open end 4111 and an inner body 4112 partially positioned within the housing 4110 and extending from the open end 4111. The biasing member 4120 may be disposed between the space 4150 inside the housing 4110, for example, the inner body 4112 and the member 4211 of the bolt 4210 of the second region 4200. The biasing member 4120 may provide a biasing force that is easy to force the inner body 4112 out through the opening 4111.

One or more holes 4113 in the housing 4110 may be dimensioned, for example, through a pin 4130 that may penetrate the elongated opening 4114 of the inner member 4112, so that the inner body may move relative to the housing 4110. It can be held by the pin 4130 inside the housing 4110. Another feature of the housing 4110 located opposite the hole 4113 may be a configuration for engaging and securing the pin 4113, as shown in FIG. 12.

The housing 4110 may have side holes (not shown) and the inner body 4112 may have side holes 4117 (see FIG. 12). The holes 4116 and 4117 can be round, oval, or other desired shape. For example, as shown in FIG. 12, the opening 4117 of the inner body 4112 is substantially elliptical. The inner body 4112 can function as a button for the housing 4110. For example, against the force of the biasing member, pushing the inner body 4112 into the housing 4110 can align the holes 4116 and 4117 so that the rod 900 can move freely along its length. When the button is released, the biasing member can force the inner body 4112 outward, which can change the alignment of the holes 4116 and 4117, so that the notch 910 of the rod 900, for example, the housing around the hole 4116 In combination with the edge of the clamp to prevent movement of the clamp 4000 against the rod 900 in at least one direction. Using this mechanism, because of the saw blade notches 910, the clamp 4000 can slide over the rod 900 in one direction, but does not weaken the inner body 4112 (eg, button) into the housing 4110 to align the holes 4116 and 4117. Without slipping in the opposite direction.

The second region 4200 of the clamp 4000 engages and secures with a member, such as an elongate member 2200 or a cannula, rod, trocar, guide conduit, wire, pin, or other elongate member suitable for insertion into the vertebral body 12, or other attachment. It may be configured to. The second area 4200 is easy to oppose the bolt 4210 or screw coupled to the housing 4110, one or more vice plates 4220 and 4230 coupled to the bolt 4210, and the biasing member 4240 and around the member 2200 (not shown). The nut 4250, which is easy to bind the vise plates 4220 and 4230, may be provided. The bolt 4210 may have a member 4211 located inside the housing 4110 and attached to the shaft 4212. End 4213 of shaft 4212 may be threaded 4214.

Vise plates 4220 and 4230 may have openings 4221 and 4231 respectively through which bolt 4210 can pass. In this way, the vise plates 4220, 4230 can be fixed above the bolt 4210, for example between the nut 4250 and the housing 4110. Each vise plate 4220,4230 may have a receiving area 4222,4232, respectively, for engaging and retaining the member 2200 or other elongated member.

A biasing member 4240 (eg, coil spring, wave washer, radial spring) may be located between the first vise plate 4230 and the housing 4110. In this way, when the nut 4250 is connected to the base 4210 but not fully tightened there, the bone connecting element is clipped or snapped between the vise plates 4220,4230, for example by inserting the bone connecting element into the receiving areas. Can be. Such a configuration may allow the bone component to be temporarily held between vise plates 4220, 4230, for example, before nut 4250.

Vise plates 4220 and 4230 also have features that facilitate proper alignment of vise plates. For example, the second vise plate 4230 may have at least one protrusion (not shown) that extends therefrom and may be received in at least one recess (not shown) of the first vise plate 4220. In this manner, the vise plates 4220, 4230 can all rotate together to face towards the receiving areas 4222, 4232. It will be appreciated that various other pins, protrusions, indentations, couplers or other alignment features may be used.

To tighten the nut 4250, the nut 4250 may have a grip 4251 (eg, serrated, rugged) that may facilitate manual-tightening of the nut 4250. Alternatively or in addition, other features may be provided on the nut 4250 to facilitate engagement of the wrench or other tool. Those skilled in the art will appreciate that other clamps may also be used with other external fastening systems shown and described.

13A and 13B are schematic diagrams illustrating a rod 900 having a notch 910 or other features that may engage one or more clamps 4000. The clamps 4000 may engage the notch features 910 and move along the rod 900 in a particular direction, for example according to the direction of the notch features 910.

The two rods 900 can be attached together by connector 950 so that the notches 910-1 and 910-2 are in opposite directions. Thus, conquest, ie movement of the clamps, can occur in the opposite direction as indicated by arrows 2710 and 2720 of FIG. 14.

In order to further rotate / move the spine using the fixation device 3000 as shown in FIGS. 5, 6 and 14, for example, using an adjustable gliding mechanism 3500 (FIGS. 17 and 18) It may be necessary to cross the members 2200 with each other (FIGS. 15 and 16). 15 and 16 illustrate an adjustable gliding mechanism 3500 connected to elongated members 2200.

17 and 18 show two embodiments of an adjustable gliding mechanism 3500 that similarly functions. The adjustable gliding mechanism 3500 shown in FIG. 17 has a slidable member 3510 that can have an "I-bar" configuration, where the vertical member 3511 moves along the entire length of the slidable member 3510 where the position members 3520, 3530 are moved. To have notches 3512 on both sides to allow it. Position members 3520 and 3530 are fixed between the horizontal members 3513 and 3514 of the slidable member 3510 to mate with the vertical member 3511. Each position member 3520, 3530 may have protrusions, or other means 3524 at side 3523,3533 corresponding to the notch 3512 in the slidable member 3510. Position members 3520, 3530 may also include release buttons 3522, 3532. For example, when actuated by lowering the button, position members 3520, 3530 may move along the slidable member 3510. That is, for example, when the protrusions 3524 are released from the notches 3512, the position members 3520, 3530 can slide between the horizontal members 3513, 3514 along the entire length of the slidable member 3510. Position members 3520, 3530 may be held between horizontal members 3513, 3514, for example, by a lip (not shown) extending from each horizontal member. Each position member 3520,3530 may have attachment units 3521,3531 that allow the elongate members 2200 to be attached to the position members 3520,3530. The attachment units 3521,3531 can be rotated to adjust the angle of the elongate members 2200 so that they can intersect with each other.

18 shows an alternative embodiment of the slidable member 3550 of the adjustable gliding mechanism 3500. In this embodiment, the slidable member 3550 has two tracks 3551,3552 parallel to each other. Each track 3551,3552 may have gear 3553 or other means to allow incremental movement of the position members 3520,3530. Position members 3520, 3530 with attachment units 3521, 3531 and release buttons 3522, 3532 function similarly to the above-described embodiment.

19 shows an alternative device for vertebral conquest. Instead of the fixation device 3000 described above, the elongated member 2200 extending from the vertebrae may have a Velcro fastener 3600 attached to their proximal end 2220. For example, by manually manipulating and controlling the elongated members 2200, after manipulating the elongated members 2200 to repair spinal lordosis, the positions of the elongated members 2200 relative to each other are determined by the Velcro Fastener 3600. It can be fixed by sticking to the elongated members mounted. The Velcro fastener 3600 may be attached directly onto the handle 2500 of the elongated members 2200 or another cap (not shown) may slide over the handle. Other methods for attaching the Velcro fastener 3600 to the handle 2500 can be envisioned.

Once the spinal segment is relaxed and conquered, the fractured vertebral body can be surgically treated.

Crushing the Healed Fracture Disrupt Healed Fracture ) (Step 1300)

Before or after the reduction of vertebrae 12a and / or 12c in the region of the fractured vertebral body 12b, the anterior region 22 of the collapsed vertebral body 12b, and in particular the cortical shell 14, is re-fractured, separated or otherwise crushed. You may need to. Such procedures are particularly useful for preparing vertebral bodies for the reduction and / or augmentation of vertebral end plates 20 and 30, for example, in cases where the fractured bone has healed or partially healed, for example, beyond six weeks or longer. Can be useful. Various types of grinding devices can be used to fracture damaged cortical bone 14, such as, for example, chisel 800, laser 900, other tools as shown in FIG.

20 illustrates a grinding device or chisel-like device 5000 that may have an elongated member 5410 with a proximal tip 5420 that may be configured to disassemble bone or other rigid structures. The elongate member 5410 may be roughly cylindrical, although other shapes are conceivable. Tip 5420 may have a variety of shapes as described herein, for example, tip 5420 may be tapered to provide a knife-shaped tip for grinding bone, as shown in FIG. 20. Tip 5420 can also be at least partially blunt to minimize damage to surrounding tissue. The handle 5430 can be attached to the distal end 5432 of the elongate member 5410, for example, the opposing tip 5420.

As shown in FIG. 20, the grinding device 5000 can be inserted into the vertebrae using a posterior approach, for example, via the cannula 5440, so that the tip 5420 penetrates the central region 50 of the vertebral body 12 of the vertebrae 12. Contact cortical bone 14 on anterior side 22. Cannula 5440 may or may not be similar to the cannulas described above.

In some embodiments, cannula 5440 may be a rigid member 5442 that may be screwed into a hole in pedicle 24, and may be cylindrical and of soft tissue around the vertebrae and surroundings to allow device 5000 to access the vertebral body in a minimally invasive manner. Elongate member 5444, which may be dimensioned to extend outwardly. The elongate member 5444 may be flexible and connected, such as for example permanently connected or detachably connected to the rigid member 5442 at the coupling 5446. Rigid member 5442 may be configured for insertion into the central region of vertebral body 12, such as through the pedicle 24 from the posterior approach. In some embodiments, the hole may be formed through the lateral cortical bone of vertebrae 12, eg, via pedicle 24, such as by means of a drill, trocar, or other tool. The coupling 5446 where the rigid member 5442 engages the member 5444 may be a location inside or outside the pedicle 24 of the vertebrae 12. In other embodiments, other types of cannula, trocar, or other guide conduit may be used to provide access for the grinding device 5000 to the vertebrae 12 or other bone.

The diameter of the member 5410 of the device 5000 can be, for example, between about 2 mm and 10 mm. Member 5410 of the device may have any desired length, for example, between about 20 cm and 70 cm. Handle 5430 may have any desired length, for example, between about 4 cm and 20 cm. The device 5000 may comprise stainless steel, metal, metal alloy, polymer, composite, ceramic or a combination thereof.

The elongate member 5410 may comprise a sleeve 5422 or other device or member disposed around and / or attached to the sleeve 5422, the sleeve 5422 may be coupled with the coupler 5446, for example, as described in more detail below. Can be dimensioned to limit the amount of axial movement of member 5410 into the vertebral body 12 by contact of.

As shown in FIG. 21, one, two or more grinding devices, for example, 5000-1 and 5000-2, for example, may have one or more cannulas 5440 as described in connection with FIG. 20. Through the vertebral body 12. Cannula 5440 may have rigid member 5442 and rigid member 5442 may include threads 5443 for securing to vertebrae, eg, through pedicles 24, as shown. In some embodiments, the rigid member 5442 has a nut characteristic with a substantially flat surface or other surfaces that can be configured to engage the wrench or other tool for screwing and / or securing the rigid member 5442 into the bone 12. May include 5447. Coupling 5446 may, for example, provide a removable connection between member 5444 and rigid member 5442.

Device 5000 may have other configurations, for example, as shown by devices 5000-1 and 5000-2 in FIG. 21. Device 5000-1 is shown with an elongated member 5410-1 with a relatively uniform diameter. In such embodiments, the member 5410-1 can move freely axially through the cannula, for example from the anterior end 22 of the vertebral body to the cortical bone 14. In other embodiments, for example, device 5000-2, member 5410-2 may include other features that limit the axial movement of member 5410-2 within stop device 5512 or cannula 5440. For example, member 5410-2 proximally moves toward the anterior side 22 of the vertebrae 12, and the stopper 5512 may contact the edge 5510 of the coupler 5446, thus preventing further movement of the member 5410-2 into the vertebral body. Or prevent it. The stop device 5512 may be provided, for example, by a sleeve 5422 surrounding a portion of the member 5410-2 and is dimensioned to provide the necessary range of axial movement of the member 5410-2 into the vertebral body 12 / Or can be adjustable.

22A and 22B show enlarged views of tips 5420, eg, tips 5420-1 and 5420-2. Tip 5420 may, for example, cut, crush or otherwise crush the bony bone 14 of the vertebrae 12 after injury, as a result of a vertebral compression fracture, for example, after the bone 14 has healed. It can have any necessary configuration. Tip 5420 may be tapered to one or more dimensions and may be tapered to provide a knife or chisel-shaped tip, for example, as shown by tip 5420-1. In other embodiments, tip 5420 may have another configuration, such as, for example, a paddle-shaped configuration, as shown by tip 5420-2, wherein the tip is member 5410-2. It may have a width larger than the diameter of. Additional details relating to tip 5420 and / or member 5410 configurations are described elsewhere herein, such as described with respect to FIGS. 28-30, for example.

FIG. 23 illustrates the spine with cannula 5440 or other guide conduits inserted into the posterior side of vertebrae 12 using, for example, tool 5700 with handle 5710 to insert cannula 5440 through pedicle 24. A perspective view is shown. Various types of cannula may be suitable for providing a passage of devices 5400 into the vertebrae 12.

FIG. 24 shows a cross-sectional view of the grinding device 5000 which may or may not be used with the cannula 5440 as described above. The grinding device 5000 may comprise an elongated member 5410 configured to penetrate through the cannula 5440, eg, through the rigid member 5442 and the member 5444. The sleeve 5422 or other member may be disposed around the member 5410 and the end 5512 of the sleeve 5422 may engage the coupler 5446 and proximal 5510 of the rigid member 5442 when the device 5000 axially advances into the vertebral body or other bone. So that it is dimensioned and / or positioned. Sleeve 5422 may be attached to and / or slidable or adjustable on member 5410, for example, to provide the required range of motion of device 5000 into the vertebrae.

The proximal end 5432 of the member 5410 may be configured as coupling to the handle 5430 is required, for example, as described in more detail with respect to FIG. 26.

25 is another side view of the grinding device 5000 when used with vertebrae 12. The elongated members 5410, tips 5420 and cannula 5440 may be as described above. In this example, the sleeve 5422 can be configured to be secured inside the cannula 5410. The sleeve 5422 may include protrusions 5433 that extend outwardly and may extend longitudinally along the long axis of the member 5410. Such protrusions 5443 are useful for providing a limit stop for the device 5000 when the device 5410 is pushed toward the bone 12 through the space 50 of the cannula 5440 and the vertebrae 12, for example by contacting the distal end of the rigid area 5442 of the implant 5440. can do.

FIG. 26 is a top view of the grinding device 5000 with the tip 5420 inserted into the vertebral 12 through the cannula 5440 to contact and break it down bone 14. The device 5000 may include a sleeve 5422 or other mechanism for limiting or controlling the penetration depth T of the tip 5420 into the cortical bone 14 in the anterior region of the vertebrae 12. The distal end 5432 of the elongate member 5410 may be secured or coupled to the handle 5430 inside the socket 5434, for example. In some embodiments, sleeve 5422 may contact end 5432 at socket 5434. Socket 5434 and end 5432 can be configured to be detachably, adjustable, fixedly connected to each other. For example, socket 5434 can be threaded and end 5432 can have a corresponding thread, so, for example, the penetration depth T of the device is determined by the amount that end 5432 is placed inside socket 5434 of handle 5430. By adjusting.

FIG. 27 is a side view of a grinding device 5000 for use in vertebrae to disassemble bones where treatment can be completed in a collapsed or fractured position. The device 5000 has a sleeve 5422 as described above, and the sleeve can function to limit movement of the tip 5410 through the bone 14. Such a restriction may be desirable, for example, if the tissues surrounding the area to be dismantled are fragile or sensitive. Arrow 1 shows the area of bone 14 that can be damaged and comminuted and that can be potentially healed later using the methods described herein.

As shown in FIG. 28, the end of the device 5000 may be, for example, using a tip 5420 configured with a sharp, semi-sharpened, or blunt tip for contact with the bone, for example, using the device 5000 with the spine 12. A hammer 2 for advancing into the anterior region can be inserted into the vertebrae 12. That is, device 5000 can be impacted against bone using, for example, Hammer 2. In other embodiments, the vibrator or other device may be attached to, for example, the handle 5430 and / or the elongated member 5410, such that the elongated members 5410 may be, for example, in the longitudinal, transverse and / or other directions. It can be used to move towards the damaged bone into the vertebrae 12.

FIG. 29 shows an enlarged side view of the device 5000 with the vertebrae 12 and the elongated member 5410 and the tip 5420 and shows the movements, lateral motion 3 and longitudinal motion 4 made possible by the device 5000.

30A-30C schematically illustrate examples of various teams 1512, 1522, 1532 that may be used to grind bone. 31 shows enlarged plan views of member 5420-1 and tip 5420-2. 31A and 31B show plan views of device 5410-2 for use with the vertebral body. 32A and 32B are enlarged views of different types of tips 1720 and 1722.

As shown in FIG. 33, a laser 9000 or other tool for cutting or fracture bone can be used in place of or in addition to a chisel or other grinding device 5000 that destroys or grinds vertebral bodies 12bdml damaged cortical bone 14 (FIG. 34). have. The laser 9000 may be configured to penetrate the cannula 2100 into the interior region 50 of the vertebrae 12b.

35 is a schematic diagram of vertebral body 12b having cortical bone 14 re-fractured using, for example, a grinding device 5000 or laser 9000. The grinding device 5000 or the laser 9000 was removed from the cannula 2100, for example in preparation for conquest of the end plates 20 and 30 to restore the height of the vertebral body 12b.

Vertebral Height Restoration (Step 1400)

After re-fracture or otherwise comminute the cortical bone 14 of the vertebral body 12b in step 1300 of FIG. 1, the height of the vertebral body 12b or the distance between the end plates 20 and 30 will be increased to a normal height (eg, the height of the vertebral body 12b before injury). Can be.

An example of a method of restoring vertebral height is shown in more detail in FIGS. 35A-35D. For example, FIG. 35A shows a partially flexible cannula 6000 inserted into vertebral body 12b. The cannula 6000, which is identical or similar to the cannula 100 described later, can have a proximal member 6100 and a distal member 6200, for example. A rigid cannula, needle, trocar or other guide conduit 6500 can be used to facilitate the placement of the cannula 6000. For example, the guiding conduit 6500, which may be dimensioned to fit within the tube 6300 of the cannula 6000, may first be inserted into the vertebral body through the pedicle, as known by those skilled in the art. The cannula 6000 then slides over the guiding conduit 6500 such that the distal member 6200 can penetrate the pedicle 24 and reach the central region 50 of the vertebral body 12b.

The proximal member 6100 can be attached or coupled to the proximal member 6200 to extend posteriorly from the spine through the soft tissues of the patient, for example, skin and muscles. The proximal 6100 can be bent or half-wheeled to allow insertion of flexion tools and to help minimize wounds in pedicle 24 and surrounding flexible tissue.

After insertion of the cannula 6000, the guiding conduit 6500 is provided with a cannula 6000 to provide a passage for insertion of the flexure rod 6700 or other tool, implant or filler into the central region of the vertebral body, as shown in step 35b. Can be removed to open the tube 6300.

As shown in FIG. 35C, a tool for conquest of the collapsed end plates of the injured vertebral body may then be inserted through the cannula 6000. For example, rod 6700, which may be bent and have head 6750, may be inserted through tube 6300 and used to push against upper end plate 20. Rod 1130 may be advanced into the central region of vertebral body 12b as shown in FIG. 35C, and the bent rod 6700 pushes apart end plates 20 and 30 to separate the height of vertebral body 12b, for example, the height h1 of FIG. 35C. To height h2 in FIG. 35D. Rod 6700 may be configured differently than described in FIGS. 35C and 35D and may have more than one piece or element and may have articulating pieces.

In more detail, one embodiment of a vertebral augmentation device provides a cannula. 36 illustrates a partially flexible cannula 100 that may have a rigid member 110 and a flexible member 120. The flexible member 120 may, for example, be permanently connected or detachably connected to the rigid member 110 at the coupling / joint 130. Rigid member 110 may be configured for insertion into the vertebrae, such as through the pedicle 24 through the pedicle 24 into the central region 50 of the vertebral body 12. In some embodiments, the aperture 60 may be formed through the outer cortical bone of the vertebra 12, eg, through the pedicle 24, such as by means of a drill, trocar, or other tool. The joint 130 where the rigid member 110 engages with the flexible member 120 may be an internal or external location of the pedicle of the vertebral body 12.

Cannula 100 may have a tube 140 (see, eg, tube 140 of FIGS. 38 and 42) that may form a passage through rigid member 110 and flexible member 120. Tube 140 may be used to insert an implant, guide conduit, tool, bone filler or other material into the central region of the vertebrae. For example, as described by flexural flexible members 120-b, the relative flexibility of flexible member 120 may minimize damage to the pedicle and / or surrounding tissue during insertion or manipulation of various implants, tools, bone fillers or other materials. Can help to prevent. The flexible member is generally positioned to provide a passage through the flexible tissue of the patient, for example skin and muscle.

As shown in FIG. 36, one, two or more cannula 100 may be inserted or implanted into vertebral body 12. If two cannulas are used, all cannula 100 can be used to introduce the tool, implant and / or bone filler into the inner 50 of vertebrae 12. The outer diameter of the cannula 100 may be, for example, between about 3 mm and 12 mm, and the inner diameter may be between about 2 mm and 10 mm. Cannula 100 may comprise any of stainless steel, metal, metal alloys, polymers, composites, ceramics, or a combination thereof.

FIG. 37 provides an enlarged view of any one of the cannula 100 of FIG. 36 inserted through pedicle 24 of vertebrae 12. Specifically, the rigid member 110 is shown inserted through the pedicle of the vertebrae 12. The rigid member 110 may be connected with the flexible member 120 at the coupling 130 just outside of the posterior side of the vertebra 12. Rigid member 110 may include threads 112 or other features that may facilitate insertion of rigid member 110 through, for example, vertebrae 12. Rigid member 110 may further include a sharpened, corrugated and / or serrated end 111 that may or may not work with thread 112 to facilitate boring through the bone.

38 and 39 show additional details of the cannula 100. In some embodiments, the rigid member 110 may have a shaft portion 113 having a length approximately equal to the width of the pedicle 24, such that the rigid member 110 may be formed with only a small portion of the rigid member extending back from the pedicle, for example. It can be fully implanted inside the tube. As shown in the cross-sectional view of FIG. 38, each of the rigid member 110 and the flexible member 120 may have substantially cylindrical walls 114 and 124 having inner and outer diameters defining the tubes 115 and 125, respectively. Tubes 115 and 125 may be joined at coupling 130, for example, to form tube 130 through the entire cannula 100.

Rigid member 110 may have a shaft or tube 113 that may or may not include threads 112. The proximal end 111 may be comprised of a tooth 116 or other cutting features extending from the end of the tube 113. The coupling 130 of the cannula 100 may detachably or permanently connect the rigid member 110 and the flexible member 120. For example, as shown in FIG. 38, the coupling 130 may include a slip fitting 131 that fits snugly within the tube 125 of the flexible member 120 and secures the flexible member 120 to the rigid member 110. The stop device 132 over the coupling 130 may provide a boundary and / or seal for coupling the flexible member 120 and the rigid member 110. The stop device 132 may include other features that may be configured to engage a substantially flat surfaces 133 or a tool such as, for example, another device for screwing and / or securing the wrench or rigid member 110 to the bone 12. Coupling 130 may provide a detachable coupling between the flexible member and / or the rigid member.

Referring to FIG. 39, another embodiment of the cannula 100 may include a rigid member 110 and a flexible member 120. However, the member 120 may be formed as a single-piece cannula 200, not connected by a coupling 130 that allows the member 120 to be separated from the rigid member 110 and the rigid member 110 to be separated from the flexible member 120. In such embodiments, the coupling or joint 210 may include floor 215 or other features that provide flexibility or controlled bending of the cannula. More specifically, member 120 may be similarly rigid as rigid member 110 but has a flexible joint 210 between rigid members 110 and 120. Member 120 may be relatively flexible compared to rigid member 110 as provided in other embodiments.

40 shows the rigid member 110 region of the cannula 100 inserted through an access hole, such as, for example, hole 60 in pedicle 24. The length of the rigid member 110 may generally correspond with the length of the pedicle 24 into which the rigid member 110 is inserted. One or more tools 810, 820 may be inserted through cannula 100 into the interior region 50 of vertebral body 12. The tools may be substantially straight, such as tool 810, or may be curved, such as tool 820. The flexible area 120 of the cannula 100 (not shown in FIG. 40 for the convenience of illustration of the tools 810 and 820) allows the curved or bent implant or tools into the internal area 50 of the vertebral 12 through the cannula 100 and the pedicle 24. Allow insertion The operating range 830 of the curved implant or tools 820 inserted through the cannula 100 may be greater than the straight implant or tool 810.

41A and 41B illustrate examples of the use of curved tools 300 and 302, respectively, with rigid members 310 and 312. Rigid members 310 and 312 may be similar to rigid member 110 as described above, and are separately defined herein to describe the relationship between the length of the rigid member and the curvature of the rod or tool that can be inserted through the rigid member. The rigid members 310 and 312 may be connected with the flexible member 120 as described above, but such flexible members 120 are not shown for clarity of explanation. The rigid member 312 of FIG. 41B is substantially shorter than the rigid member 310 of FIG. 41A. As described, the rigid member 312 can receive a tool 302 with a greater curvature than can be accommodated by the longer rigid member 310. Thus, the amount of curvature of the tool or implant that may be used with the cannula 100 may depend, at least in part, on the length of the rigid members 310,312 (and 110), the diameter of the rigid member and the diameter of the tool or implant shaft.

42A and 42B, the flexure rod 500 is configured to have the diameter and curvature necessary to fit through the partially flexible cannula 100 and can be used to restore spine height in the collapsed vertebrae 12. The rod 500 is inserted into the cannula 100, the flexible member 120 can be bent together with the rod 500 and the rigid portion 110 functions to regulate and limit the movement of the rod 500 within the vertebra 12. In some embodiments, the proximal end of the rod may include a bulb or ball 510 that can enter the central region 50 of vertebral body 12 and engage with the upper end plate 20 of vertebral body 12. The bulb 510 may blunt the tip of the rod 500 to distribute the pressure to a larger area. As the rod 500 advances, as shown in FIG. 42B, the end 510 of the rod 500 can be pushed against the end plate 20 and increase the height of the vertebral body between the upper end plate 20 and the lower end plate 30. With or without bulb 510, the tip of rod 500 can compress the reticulated bone of the vertebral body to form a hollow space, ie a cavity.

In some embodiments, rod 500, or portion of rod 500, remains in place after restoring vertebral height, consequently restoring vertebral lordosis to augment the vertebral body. For example, one or more portions of rod 500, eg 510, may be selectively separated from the rest of rod 500 to function as an implant remaining inside central region 50 to augment vertebral body 12. In other embodiments, additional tools, implants, bone chips, bone cement and / or other filler materials may be used with rod 500 and / or cannula 100 to increase and / or fit vertebral height.

After using tools such as cannula 100 and rod 500 to conquer the vertebral body, some or all cannula 100 may remain in place. For example, the flexible member 120 can be separated from the groove member 110 and the rigid member 110 can remain in place within the vertebral body.

As shown in FIGS. 43A-44D, various configurations of tools and implants may be used. For example, rods or other tools may have any desired shape, such as shapes 610, 620, 630, 640 or 650. Similarly, rods or other tools that may be used with the partially-flexible cannula may have any necessary bends, such as rods 710, 720, 730 and 740.

Augmentation of the vertebral body (step 1500)

After conquering vertebral 12 to restore vertebral lordosis, and after restoring the height of vertebral body 12b, vertebral body 12b can be, for example, bone cement, bone chips, demineralized bone, other filler material, or a central region of the vertebral body 50 It can be augmented using fillers such as implants inserted into the implants.

FIG. 45 illustrates a flexure rod 6800 that may be used to conquer vertebrae 12b as described above, where rod 6800 is an end cap or ball 6820, such as one or more holes 6810 near the distal end. Can have The holes 6810 can be used to remove bone material from the vertebrae or to introduce bone cement or other bone filler into space 50, for example, to fix or augment the restored vertebral bodies. For example, the holes 6820 may be in communication with the hollow tube 6830 of the rod 6800 through which bone filler, cement, bone chips, or the like may be injected. Bone fillers, cement, bone chips, etc. can be inserted simultaneously with rod 6800 to conquer the end plates of the vertebrae, and bone fillers, bone cements, implants, and bone chips can be applied to the rods to conquer the end plates. It can be inserted into a damaged vertebra without adding force.

As shown in FIG. 46, in other embodiments, a curved tool, such as a curved rod, may be removed from the vertebrae 12b. Needle 6900 and / or other catheter or cannula may then be inserted through cannula 2100 to inject bone filler, bone chips, bone cement, and the like into the vertebrae. Bone fillers, bone chips, bone cements, implants or other reinforcement devices can be inserted into the vertebrae with or without initially conquering the end plates of the damaged vertebrae, and sufficient to conquer the vertebral end plates without the aid of additional tools or devices. Can be inserted by force.

In some embodiments, the required filler material may include particles that are too thick or too large to be delivered through the syringe 6800 as shown in FIG. 45 or the syringe needle 6900 as shown in FIG. 46. In such cases, particulate or other non-fluid filler material may be inserted into the vertebral body 12b by other means, for example using a spiral conveyor or other device for delivering the filler material.

47A-47C show commercially available spiral conveyors 10200 (MEVA shaftless screw conveyors, VoR Environmental, Botany, NSW, Austrailia) and 10300 (Spirolow Flexible Secrew Conveyor, Spiroflow Inc., Monroe, An example of devices 10000 and 10100 with NC) is shown. The screw features of such spiral conveyor devices can be adapted or adapted to deliver filler material to augment the vertebral body 12. Such spiral conveyor mechanisms can, for example, deliver filler material under low pressure rather than injecting with a syringe. Low pressure while augmenting the fractured vertebra may help to avoid leakage of filler material.

48 shows an example of a spiral conveyor apparatus 11000 used to augment a vertebral body 12. Hopper 11100 may be employed to retain filler material to be inserted into the vertebral body through cannula 2100 inserted into the vertebral body as described above. Hopper 11100 may be in communication with tube 2110 of cannula 2100, for example, via valve 11299. Screw 11500 may pass from valve 11200 through cannula 2200 into central region 50 of vertebral body 12. The crank 11300 or other mechanism can be rotated, for example, manually or using a motor (not shown) to turn the screw 11500. During rotation, filler material 11400 exiting hopper 11100 can enter the space between threads 11510 of screw 11599 and be transferred into space 50 along the length of screw 11500.

Those skilled in the art will appreciate that each of the steps, apparatus and methods described herein, may be used in conjunction with and / or in conjunction with various other methods and apparatus. For example, a kit for performing one or more steps or portions of the methods described herein may include one or more packages, various combinations of components and assemblies described herein. The kit may include, for example, one or more cannulaes, grinding devices, external anchors, and filler or bone filler material. Such embodiments may include one or more syringes, conveyors or other devices for injecting a semi-viscous fluid or non-fluid filler material into the vertebral body.

In another embodiment for augmenting the vertebral body, the tool 13000 as shown in FIG. 49 can be used for correcting minimally invasive lordosis of the spine. Tool 13000 may include at least two body segments 13100 connected with joint 13200. The joints between the body segments are preferably ball joints, universal joints, or other types of joints. Preferably, the joints allow the body segments to rotate multiaxially with respect to each other and provide at least rotation or rotation about the axis. Body segment 13100 may be cylindrical in shape. Alternatively, the body segment can be deformed and have a different cross sectional shape. The body segments are preferably rigid so that the adhesion applied to the proximal end 13001 of the tool 13000 will be transmitted to the distal end 13002. The elongate member 13300 can be made from metal, polymeric ceramics, composite materials, or combinations thereof.

In addition, those skilled in the art will understand that body segments may vary. Wires, strings, other elongate members, preferably flexible elongate members 13300 may be connected to the foremost or distal body segment 13100a. The term 'head' or 'distal' portion of the instrument 13000 refers to the end 13002 of the instrument positioned away from the portion handled by the surgeon. On the other hand, the back end, back end, or distal end 13001 of the tool 13000 represents the end of the tool that is not located in the body of the vertebrae handled by the surgeon.

In its normal or resting position, when no force is applied to the elongated member 13300, the body segment 13100 and the joint 13200 are preferably configured such that the body segments 13100 can be aligned along the straight or longitudinal axis 13003 of the tool 13000. . When the elongated member 13300 is pulled, the body segments 13100 no longer coincide with the longitudinal axis 13003 at the distal end 13002 where the elongated member 13300 is attached, resulting in a bend 13004 of the tool.

To use the tool 13000, the cannula 2100 is inserted through the pedicle of the broken vertebra 12 (FIG. 50). The tool 13000 is inserted through the cannula 2100 so that the distal end 13002 of the tool 13000 is located inside the body of the collapsed vertebrae 12 (FIG. 51). The tool 13000 is inserted below the cannula 2100 by applying a pushing force to the proximal end 13001. The tool 13000 is rigid enough so that the force is transmitted along the tool 13000 and moves it inside the cannula 2100 into the vertebral body. The distal end 13002 of the tool 13000 may then be bent / elevated by pulling on the elongated member 13300 (FIG. 52) toward the proximal end 13001 of the tool 13000. If sufficient force is applied, the end plates 20,30 of the collapsed vertebral body 12 may be pushed apart as a result of the body segment 13100 exerting the end plates 20,30, and the vertebral body at its original height (FIG. 48). Can be restored. In addition, the bone of the vertebral body 12 around the distal end 13002 of the tool 13000, or the leading distal body segment 13100a, can be densely packed, thereby reducing the risk of cement leakage. Movement of the end plates 20,30 and / or bone density can create a cavity 51 in the vertebrae.

54-56 show other mechanisms for pulling the elongate member 13300 of the tool 13000. These other mechanisms may form part of the tool 13000 and may be separate assemblies used with the tool 13000.

54 shows a kind of bobbin 14000 that can be used to pull the elongated member 13300. The bobbin 14000 may include two supports 14300 attached to the platform 14200 with shafts 14400 attached to the two supports 14300. Knob 14100 can be attached to the shaft and used to rotate the shaft to pull the elongated member 13300, thereby raising the distal end 13002 of the tool 13000.

55 shows screw nut assembly 15000. The screw nut assembly 15000 may form the rear portion of the tool 13000 or may be attached to the proximal end 13001 of the tool 13000. The screw nut assembly 15000 can include a threaded shaft 15100, a nut 15200, and a casing 15300. The elongated member 13300 may be attached to the threaded shaft 15100. Rotating the screw nut assembly causes the elongated member 13300 to be pulled back as a result of the threaded shaft 15100 moving against the nut 15200 and the casing 15300, thereby raising the distal end 13002 of the tool 13000. When the distal segment 13100a is bent and raised, the body segments 13000 are articulated relative to one another as a result of the movement allowed by the joint 13200. For example, by means of a spring member a biasing force can be applied by the joint 13200 to keep the body segments in the resting position, a position where the body segment 13100 can align along a straight or vertical axis 13003. have. While longitudinal axis 13003 is shown as a straight line, it is understood that longitudinal axis 13003 may be bent.

Similarly, FIG. 56 shows screw assembly 16000. The screw assembly 16000 can include a screw 16100 and a casing 16200. Either elongate member 13300 is connected to screw 16100. As the screw 16100 is rotated, the elongated member 13300 is correspondingly pulled back, raising the distal end 13002 of the tool 13000.

57A-57C show another configuration of the tool 13000. Depending on the application, the number of body segments 13100 and joints 13200 may vary. 57A shows the tool 13000 with three body segments 13100 and two joints 13200. 57B shows the tool 13000 with two body segments 13100 and one joint 13200, and FIG. 57C shows the tool 13000 with five body segments 13100 and four joints 13200.

58A and 58B show two different types of joints 13200 that may be used. 58A may be constructed from a polymer without a joint or from a shape memory alloy (eg, nitinol) (FIG. 59). When the elongate member 17000 is pulled, the distal end of segment 17100 of the tool 17000 is bent upwards so that the distal end can be laterally offset from its original position along the longitudinal axis of the tool, thereby pulling apart the end plates of the collapsed vertebral body. The vertebral body can be restored to its initial height.

In another embodiment of the invention, the tool 18000 shown in FIG. 60 has a main body segment 18100, at least one adjustable segment (FIG. 60 shows two adjustable segments), and an elongate member 18300. can do. The tool 18000 may include a mechanism 18400 for raising the adjustable segment 18200 by holding the elongated member 18300.

Although the invention and its advantages have been described in detail, it will be understood that various changes, substitutions and alterations are possible without departing from the spirit and scope of the invention as defined by the appended claims. Moreover, the scope of applicability of the present invention is not intended to be limited to the particular embodiments of the process, machine, manufacture, composition, means, methods and steps described herein. Those skilled in the art, from the disclosure of the present invention, employ processes, machines, manufactures, compositions, means, methods or steps that perform substantially the same function or produce substantially the same results as the corresponding embodiments described herein in accordance with the present invention. It will be appreciated that it can be used. Accordingly, the appended claims are intended to be included within such processes, machines, manufacture, compositions, means, methods or steps.

The devices and methods described herein have been described in the sense of conquering, crushing, and augmenting vertebrae in terms of deformation of vertebral compression fractures and vertebral flexion, but for example, long bones, ribs, and other bone anatomy Various other uses and methods are foreseen, such as conquering and increasing. In addition, in some embodiments, a partially flexible catheter may be used to insert an implant, such as, for example, a chain of one or more flexible connected bodies. Bone cement, bone chips or other fillers may be used to aid in the buildup. In other embodiments, another implant 3430 may be inserted.

In some embodiments, the implants and methods described herein may be used in conjunction with other devices and methods for repairing vertebral lordosis and augmenting the vertebral body. For example, one or more partially flexible cannula 100 may be used in conjunction with other known procedures, such as spinal or balloon angioplasty that may be used to initiate conquest of the vertebral body and / or form a space inside the vertebral body for implants. Can be.

In other embodiments, various minimally invasive implant methods for alleviating discomfort associated with the spinal column may employ anchors and other implants described herein. For example, an implant having one or more connected bodies inside an inflatable container (not shown) relaxes the spinous processes and is caused by, for example, spinal stenosis, facet arthropathy, or the like. It may be implanted between spinous processes of adjacent vertebrae to alleviate pain and other problems. For example, the augmentation system described herein can be used in place of or in addition to the expandable intervertebral spinous process devices and methods disclosed in US Patent Publication No. 2004/018128 and US Patent Application 6,419,676 to Zucherman et al. have.

While the foregoing description and drawings illustrate preferred embodiments of the invention, it will be understood that various additions, modifications and substitutions may be made without departing from the spirit and scope of the invention as defined in the appended claims. . In particular, it will be apparent to those skilled in the art that the present invention may be embodied in other specific forms, structures, arrangements, proportions, and may be implemented with other components, materials, and components without departing from the spirit or essential characteristics thereof. will be. The presently disclosed embodiments are to be considered in all respects as illustrative and not restrictive, and the scope of the present invention is defined by the appended claims and should not be limited to the foregoing detailed description.

Claims (20)

At least one elongated member, each of the elongated members having a first end and a second end, wherein the first end of each elongated member is inserted into a vertebral body Is configured to; A fixed rod having an arch shape; And At least one clamp configured to adjustably secure one second end of the elongate member to the securing rod, And the clamp is configured to move along the stationary rod to pivot the elongated member to conquer a vertebral body. The method of claim 1, And a handle coupled to the second end of the elongate member. The method of claim 1, Two or more elongated members are vertebral conquest devices, characterized in that they are tubular bodies with lumens along their length. The method of claim 1, The stationary rod has a plurality of surface features arranged along the longitudinal axis of the stationary rod; The clamp has a first configuration, wherein the clamp is movable in a first direction along the longitudinal axis of the stationary rod, and second surface features to prevent movement in a second direction along the longitudinal axis of the stationary rod Spine conquest device, characterized in that combined with. The method of claim 4, wherein The clamp has a button and has a second configuration, wherein the button releases the clamp from the surface features of the stationary rod to allow movement of the clamp in the second direction. . The method of claim 1, Further comprising a cannula having a first end, a second end, and a lumen that provides a passageway from the first end to the second end, the first end configured to be inserted into the fractured vertebral body. A vertebral conquest device characterized in that. The method of claim 1, Said elongated member comprises any one selected from the group consisting of stainless steel, metal, metal alloys, polymers, composites, ceramics or combinations thereof. (a) forcing a region to repair vertebral lordosis in the region of the injured vertebral body; (b) fracture the damaged vertebral body; (c) restoring the height of the damaged vertebral body; And (d) augmenting the vertebral body; the method of treating a damaged vertebral body comprising a. The method of claim 8, Repairing the spinal lordosis is: Inserting a first elongate member into the vertebral body, said vertebral body being near a first end of said damaged vertebral body; Inserting a second elongate member into a second vertebral body, said second vertebral body adjoining a second end of said damaged vertebral body opposite said first end; Moving the first elongated member to change the position of the first vertebral body with respect to the damaged vertebral body; And Positioning the first elongate member over the anchoring rod. The method of claim 9, And wherein said elongated members are positioned in said stationary rod prior to moving said first elongated member relative to said injured vertebral body. The method of claim 9, And wherein said moving step places said first elongated member relative to said damaged vertebral body. The method of claim 9, And the positioning step comprises securing the first elongated member to articulate the securing member with the first clamp. The method of claim 12, The moving step is: Stage P which disassembles the first clamp from the fixed rod; Rotating the elongated member; And Re-engaging the first clamp with respect to the fixation rod to fix the position of the first vertebral body. The method of claim 12, And the moving step includes moving the position of the clamp connected to the elongated member along the longitudinal axis of the fixation rod. The method of claim 12, Repairing the spinal lordosis further comprises inserting a cannula into the damaged vertebral body and fixing the cannula to the fixation rod. The method of claim 8, Fracture the fractured vertebral body: Through a posterior approach, inserting a cannula into the damaged vertebral body, the cannula having a tube dimensioned to provide a passage into the vertebral body; Inserting a grinding device through the cannula; Fracture the damaged vertebral body using the grinding device. The method of claim 8, Restoring the height of the damaged vertebral body includes: Inserting a cannula into the damaged vertebral body, the cannula having a tube configured to retract a passage into the vertebral body; Inserting a tool through the cannula up to the vertebral body; And Moving the end plate of the damaged vertebral body using the tool to recover the height of the damaged vertebral body. The method of claim 17, The access tool comprises a flexure rod having a longitudinal axis and a distal end configured to contact the longitudinal axis and the bone; Moving the end plate includes advancing the flexure rod through the cannula, contacting the end plate with the distal end of the flexure rod, and applying force along the longitudinal axis of the flexure rod to conquer the vertebral endplate. A method of treating an injured vertebral body, characterized by moving the endplate away from the opposite endplate of the bone. The method of claim 8, A method of treating a damaged vertebral body further comprising the step of inserting a cannula into the damaged vertebral body prior to the recovering step, wherein the cannula has a tube dimensioned to provide a passage into the vertebral body. The method of claim 8, And said fracture step is performed prior to said repair of vertebral lordosis.

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