KR20070020385A - Artificial disc devices - Google Patents

Abstract

Disclosed is an artificial disc device for replacing damaged nuclei. In one form, the device can be inserted as a component so that it can be assembled and maintained in a natural ring. In another form, the device can be inserted into the natural ring in a folded or compressed state or arrangement, and then expanded and held within the ring. In another form, the device can be connected in an insert form with a releasable connection and can be released in an operative form. Also disclosed are insertion mechanisms and methods.

Artificial disc devices, rings, vertebrae, nuclei

Description

Artificial Disc Device {ARTIFICIAL DISC DEVICE}

Description of related application

This application is a CIP application of US Patent Application Serial No. 10 / 282,620, filed Oct. 29, 2002, under the heading "Artificial intervertebral disc device," and filed Oct. 22, 2003, under the heading "Artificial disc device." CIP application of US patent application Ser. No. 10 / 692,468, both of which are incorporated herein by reference in their entirety.

Field of invention

The present invention relates to an artificial intervertebral implant, in particular an articulated implant that allows for the relative articulation and / or translation of multi-piece parts.

The most common orthopedic condition requiring specialist medical attention is lower back pain. There are many factors that cause lower back pain, but the main factor is the damage or degeneration of the intervertebral discs, which impinge on the nervous system, especially the spinal cord, located within the spine. Such a collision can cause, for example, movement impairment, urinary and stool incontinence, and pain or sciatica in the extremities.

Damage or degeneration of the spinal disc can result from a variety of factors, such as abuse or age. The disc itself consists mainly of the annulus and the nucleus contained in the ring. The ring is the portion of the fiber ring that attaches to the adjacent vertebra and contains the nucleus, the nucleus being a viscous material such as a flowable gel that can absorb shocks and allow multiaxial rotation and elastic compression of the vertebrae and spine. The most common disc degeneration results from damage to the ring, which causes fluidic nuclear material to leak or leak out of the ring. Disc degeneration can also occur in other ways, such as by deprivation of nutrient flows leading to dry discs and by making the discs more prone to damage. Because nuclear material is fluid, leakage does not require major damage to the ring.

There are a variety of treatments for spinal problems that are currently being performed directly on the spinal column. For example, fixed and high dose corticosteroids can be used. Major treatments for treating these problems include spinal fusion and discectomy. Fusion involves the fixation of adjacent vertebrae, the growth of bones between and between the vertebrae, permanently anchoring the intervertebral discs, while discectomy involves the removal of some or all of the intervertebral discs.

However, each of these methods currently in practice generally has certain disadvantages. Fusion, which generally hardens a part of the spine, results in reduced movement, which dramatically changes the normal load distribution along the spinal column. Due to these factors, the nonunion of the spine experiences significantly increased compression and deformation during normal physiological operation. Increased compression and deformation of the nonunion site can accelerate disc degeneration of the nonunion site, particularly adjacent to the spine.

Intervertebral discectomy is effective in relieving sciatica by removing damaged or dislodged disc tissue that presses on the spinal nerves. However, current discectomy may not only reduce the disc space between adjacent vertebrae but also lead to instability of the treated spinal region. The long-term effects of current discectomy may require additional surgery several years after initial discectomy.

This type of spinal surgery, although not up-to-date, is a method known as disk arthroplasty that uses a prosthesis to replace part or all of a damaged disk to restore or rebuild the disk. The main purpose of disc arthroplasty is to treat and treat the cause of pain while restoring or maintaining normal disc anatomy and function. However, prosthetic disc implants have had little success because of the complexity of the natural disc structure and the biomechanical properties of the natural intervertebral discs. As used herein, the term "natural" refers to normal tissue, including the spine and portions of the disc.

Two types of prostheses used in disc arthroplasty are currently thought to be further developed through medical and medical research. One type is a complete disc prosthesis or TDP that replaces the entire intervertebral disc after radical discectomy. A typical TDP includes a structure that mimics the properties of a natural disc.

Another type is a disc nuclear prosthesis or DNP used to replace only the nuclei of the intervertebral discs after nucleotomy while keeping the disc's rings and possibly the end plates intact. As mentioned above, dysfunction of natural discs does not require significant damage to the rings, and the rings may often carry a non-flowing artificial nucleus. Implantation of the DNP includes removing the natural nucleus from the ring via a method known as nucleectomy and inserting the DNP into the ring. Thus, disk nuclear prosthesis (DNP) is generally smaller in size than TDP and requires less surgery.

When using disc implants, current publications of DNPs and TNPs that attempt to imitate the biomechanical properties of natural intervertebral discs have many problems. Some implants are designed to provide shock absorption similar to natural discs. However, these discs have been found to be unable to maintain structural integrity during the essential cyclic load life of the discs, which can generally be used for more than 20 years. In addition, early attempts to provide multiaxial movement and rotation of the spine involved replacing discs with metal balls. However, this attempt unfortunately concentrated the load between the ball and the end plate, causing bone collapse, causing the collapse of the vertebrae around the ball.

Another problem is implant extrusion, which is defined as the tendency for the implant to be pushed back from its intended position without maintaining its position. To prevent this, various designs of disc implants have been attempted to provide secure features to the implant to secure it to the end plates of the vertebrae. Such fixation features are generally prong or spike systems or other physical protrusions designed to be embedded in the vertebrae. This alone impairs the integrity of the end plate to the extent that orthodontic surgery is limited, which is probably limited to spinal fusion, which fixes the spinal segment and fuses the vertebrae with posterior pedicle technique. Invasion of the vertebrae by this fixation can lead to bleeding or calcification of the end plate, all of which can cause pain, loss of motion, necrosis or degeneration of all implanted devices. In the occlusion of the end plate and the implant, the compression concentration may be due to the appearance mismatch as caused by the implant balls described above. That is, placement of the implant, in particular placement of the implant utilizing the protrusions, should be done with care. In order to reduce this high pressure concentration or pressure point on the vertebra, the implant often has a top and bottom plate covering each vertebra, and a retaining feature on the plate to secure each plate to the vertebra. In this way, the pressure or force is generally distributed.

Most implants are monoliths that are transplanted entirely. Thus, the adjacent vertebrae should be wide enough for the actual size of the implant, including the upper and lower plates, which can be significantly increased when fastening protrusions are provided. This requires invasive enlargement, which complicates surgery, prolongs recovery time and leads to postoperative pain. Moreover, because the incision must be made large, any usefulness that remains even if the ring is retained is often destroyed. These rings are not well healed, and the sutures of the rings are difficult due to their tissue properties, so the properties of the rings that carry the implants are not lost but are reduced, and in some cases, the extrusion of the implants is often not blocked by the rings.

Some implants that are inserted entirely use structures such as bladder or balloon. Such implants can be inserted folded and then expanded in situ at the site. However, such implants should generally be fully elastic, deformable structures. Therefore, such implants are generally limited in absorbing shock and do not provide a range of motion due to high circulation load or sufficient bearing capacity.

Most intervertebral discs require an anterorio-lateral approach to the surgical site. More specifically, the intervertebral disc implants are generally similar in size to natural intervertebral discs. Space is needed to empty the disc space and implant artificial devices. Due to the geometry and structure of the vertebral, natural disc and artificial disc implants, posterior surgical procedures generally make the disc space empty and the access necessary for implanting an artificial device impossible. In addition, the anterior approach to the surgical site generally requires the use of general surgeon techniques with orthopedic or neurosurgery, or both. Therefore, implant devices that can be implanted with multiple surgical approaches are desirable.

Less extensive surgery is more suitable for DNP than for TDP. DNP replaces only part of the disc. Most DNP transplants with a preformed size require an incision of 5-6 mm or larger in the ring to be implanted. Some DNPs can be performed percutaneously, such as when using in situ curable polymers. In any case, transplantation of DNPs requires minimal excision of the disc tissue and does not need to invade the end plates of the vertebrae to fix. Moreover, recovery time and postoperative pain are least due to the minimal invasiveness of the procedure, and intervertebral fusion is feasible as corrective surgery.

In particular, it has been found that it is important to restore the spine to its normal range. In particular, it has been found that it is more important to provide bending / extension, lateral bending and axial rotation of the spine than to provide an elastic compression rate. More specifically, grafts that do not provide a normal range of motion are thought to exhibit the adverse effects of spinal fusion as described above. On the other hand, it is thought that the loss of compression elasticity may be caused by other natural intervertebral discs. However, since the implant is necessary to restore or maintain the disc height, it must withstand significant compressive loads in a suitable physiological manner, and therefore no end plate damage that can lead to pain and implant drop should be induced.

The attempts made on artificial discs are numerous, but all have drawbacks. Some procedures and devices are only capable of lateral or anterior surgical procedures, which increase invasiveness and trauma and at the same time carry a high surgical risk.

Thus, there is an urgent need for improved disc implants that mimic the biomechanics of natural discs.

Summary of the Invention

According to one aspect of the present invention, there is disclosed an articulated nuclear implant device useful for the replacement of nuclei removed by nucleectomy. Such implants may include at least a first shell or plate member, a second shell or plate member, and a bearing member, preferably a multiaxial articulated bearing member, which provides one or more movements between the two shells. Such articulated bearing members provide natural movement of the spine, including bending / extension, lateral bending and rotation. Each plate member and articulated bearing member are generally made to be rigid. Thus, the implant can support the compressive and cyclic loading required for the natural disc.

In some forms, the implant may also have relative sliding and / or translation between the sheath and the articulated bearing member. Specifically, the surface between the shell and the articulated bearing member can slide relative to each other. Since the dynamics of natural discs are viscous fluids, bending in one direction of the spine moves the fluid in the opposite direction. Because of this bending force of the implant, the shell of the implant rotates relatively in a particular manner. However, due to the size requirements of the implant, the skin does not need to rotate around a fixed axial point. In this way, the articulated bearing member allows the implant components to move relative to each other to mimic the behavior of natural nuclei and to do so as a rigid member. In addition, some forms of implants allow the central insertion or spacing member to move by slide and / or translation or separately from the bending direction to be closer to natural disc behavior as described below.

One aspect of the invention relates to a multi-axis articulated device using a dome member and a concave groove formed between the shells. The dome member and the groove form an articulated bearing member to allow the shell to move relative to one another in a multiaxial manner, and the dome surface and the groove can slide or translate relative to each other.

In some aspects, the articulated bearing member can adjust and vary the stiffness of the multi-axis rotation. Each radius of curvature of the groove and the dome surface, and thus the fit between the groove and the dome surface, can be varied to vary the stiffness. In general, when the radius of curvature of the groove is larger than the radius of curvature of the dome surface, the limiting state becomes smaller and thus the rigidity is lowered. In contrast, if the radius of curvature of the groove is smaller than the radius of curvature of the dome surface, the limiting state becomes larger and the rigidity is increased.

As another aspect of the invention, the outer surface of the implant in contact with the end plates of the adjacent vertebra may have a convexity selected according to the concavity of the entire natural end plate. When the convex surface of the implant outer surface matches the concave surface of the end plate, the force will generally be distributed evenly along the end plate, so that no high pressure points are formed. This implant structure also does not cause bone drop problems, so the integrity of the end plates is maintained. If corrective surgery is required, various preferred methods of surgery may be used.

Alternatively, the convex surface of the implant outer surface may be slightly reduced. The bones of the terminal plate can deform slightly elastically. A slight mismatch between the lateral side and the end plate results in residual compression between the outer circumference of the lateral outer shell and the end plate, which acts to keep the generally convex lateral side of the implant in place. Any such deformation should be limited to such that no bone drop occurs.

According to another aspect of the invention, the implant is generally oval or racetrack-shaped. Natural discs and nuclei are kidney-shaped in which the size of the front and rear directions is smaller than that of the lateral sides. Thus, the space resulting from nucleation has a similar shape. It has been found that the performance of implants, with or without kidneys, is favored by making the lateral size of the shell (hereinafter also referred to as transverse size) wider than the front and back size (e.g., common ovate, racetrack or trapezoidal). For further reduction of the incision size for the ring, which acts to improve the properties of the ring that blocks the extrusion of the implant, the sheath of the implant may first lead the lateral end first through the rear incision of the ring. In this way, the shell can be axially rotated in the nuclear space.

In order to facilitate the rotation of the sheath within the nuclear space, aspects of the present invention include posts for grasping, inserting and rotating one or more sheaths. The pillar may have a flat portion and a spherical portion to allow the tool to hold the pillar in a first position so that the pillar does not rotate relative to the instrument during insertion. Once inserted, the pillar can be partially released so that the instrument no longer contacts the flat portion, and the pillar can rotate relative to the instrument without being fully released. The instrument can then induce rotation of the shell within the nuclear space.

In addition, the distraction of the rings has been found to help relieve pain and increase the stability of the intervertebral joint. As mentioned above, the shell of the implant does not necessarily resemble the shape of the natural nucleus. If the shape of the implant does not match the shape of the natural nucleus, the outer circumference of the implant may spread a portion of the abutting ring, which creates tension in that ring portion. In addition, outer curtains or sheaths, for example in the form of corrugated bellows, can be connected between the sheaths, generally sealing the compartments between the sheaths. Such bellows can then be infused with a substance such as gas or liquid, whereby the bellows or curtain can expand and apply pressure to the interior of the ring. In addition, the injected material may slightly inflate the nuclear implant in situ. As a further advantage, the bellows block the ingress of impurities into the implantation device that can interfere with or degrade the performance of the implant, especially the articulated bearing member.

In another aspect of the invention, it is desirable to limit the back and forth bending of the implant. In general, the maximum deflection between the vertebrae is about 15 °. However, the implant according to the present invention may provide about 15 ° in the lateral direction and allow for greater movement in the lateral direction due to the multiaxial mobility. Thus, in some embodiments, it is desirable to block the kinematically so that the deflection does not exceed 15 °. In one form, the sheath comprises a short wall extending towards the opposing sheath that is in physical contact upon reaching a 15 ° bend. In another form, the spacer member may be an annular ring extending at its outer circumference and is present between the shells so that the shell contacts the ring when the shell reaches a 15 ° angle. In another form, the sheaths may be provided secured together by cables connecting the sheaths so that the sheaths do not bend at least 15 ° and the spacers do not escape between the sheaths.

In some embodiments, each sheath can be prepared for rotation, sliding or translational movement, and the inserter or spacer member can have two surfaces located between the two sheaths and moving against each sheath. Multiple wear surfaces at the interface are believed to increase the average life of the implant with respect to wear. In some forms, each sheath can have a concave groove, and the spacer has two dome surface portions opposite each sheath, forming articulated bearing members each having a concave groove. In another form, the spacer member can hold a dome surface in one face that conforms to the concave groove in the sheath, to perform multi-axis rotation, translation, and slide movement, while holding the flat portion in contact with the flat surface in the groove of the sheath on the other face. Linear translation and planar rotation.

According to some forms of articulated implants, articulated implants are disclosed in which parts can be sequentially inserted through incisions in a ring to be assembled in disc nuclear space. In this case, the incision does not need to have the space necessary for the entire implant to be inserted, and the invasiveness of the procedure is minimized, resulting in reduced postoperative recovery time and pain. In addition, any flaring of adjacent vertebrae that needs to occur is minimized by inserting the implant into the part. Since the incision is not enough to insert the entire implant, integration of these remaining rings can be facilitated. In particular, the rings can be used to keep the implant in position in the nuclear space within the ring. Thus, projections for securing the implant to the end plates of adjacent vertebra are unnecessary to keep the implant from deviating between the vertebrae.

According to a similar form of the articulated implant, each shell may comprise a concave groove and a double-domed spacer member. By providing a dome surface for each groove, wear on the interface is reduced as described above. The parts are inserted sequentially in any order through the incision of the ring, but it is preferred to insert the shell first to prevent damage to the end plate. The sheath may comprise a ramp or similar structure aligned with respect to the side of each concave groove that allows the spacer member to be inserted therebetween. In addition, the spacer member may be rotated or translated one or more times after being inserted, such that the spacer member does not escape through the incision of the ring and / or further inflate the implant. This aspect is for multiaxial movement, in which the sheath slides and / or translates relative to the spacer member, respectively, and allows the spacer member to slide or translate opposite to the bending direction. It should not be overlooked that the maximum removal rate provided by the cutout of the ring is sufficient for the largest of the three parts.

Another form of articulated implant includes a shell having a concave groove as described above, a shell having a step or slope that rises toward the center and a spaced member having a step or slope on one side and a dome on the other side. At this time, the envelope may be inserted through the incision of the ring so that the stepped portion of the envelope faces the incision. The spacer member is then press-fitted between the shells so that the stepped spacers cam-raise over the steps of the casing shells until the dome surface is received in the concave groove of the other shell. The stepped portion of the skin includes sidewalls that generally lead the path of the stepped spacer. This side wall may be arranged so that the spacer member can slide or translate slightly along the stairs and also prevent excess translation. Preferably, the stairway of the sheath extends from the side of the sheath. In one form, the casing is rotated after expansion, and in other forms, the casing is rotated and then the implant is expanded.

In another aspect of the present invention, an articular implantable device is disclosed in which the entire implant is inserted through the incision of the ring. Such implants are inserted as a monolith in a compressed or folded state and expanded after implantation. The size of the ring incision is sufficient for the size of the pre-expansion implant. As noted above, the implant can first be inserted leading the short side sized end, and then rotate immediately after the trailing portion of the implant is inserted into the incision. Alternatively, rotation may begin before the implant is fully inserted through the incision, where rotation occurs when the implant is pushed through the incision. Thus, the incision is sufficient to insert a compressed implant, and the invasiveness of the procedure is also minimized to minimize postoperative recovery time and pain, minimize bulging of adjacent vertebrae, and allow the loop to retain the implant in place. Will not require a protrusion to fix the implant.

According to one aspect of this aspect, an implant is provided having a spirally stepped spacer member that can be inserted folded and then expanded. This stepped spacer allows the implant to expand in stages to the desired vertical height. At least one sheath has a concave groove in which the dome surface of the spacer member is received. The spacer member has two opposing portions, one of which may be integral with the second sheath or may have a dome surface received in the concave groove of the second sheath. Opposite portions of the spacer member have helical steps, and the spacer member and / or implant can be inserted into or assembled in the nuclear space in a compressed or folded state or arrangement. Upon implantation, the opposing portions of the spacer members rotate relative to each other to climb the stairs, expanding the spacer members in an expanded arrangement. Each dome surface and groove is for multiaxial movement, translational movement and arcuate sliding movement of the implant as described above.

In another aspect, the spacer member may have a member that rotates about a longitudinal axis and may be connected to one or more non-rotating wedges. The rotating member rotates to pull or push any wedge from the first compression position to the second expansion arrangement. The wedge is pressed between two portions of the spacer member to inflate the spacer member and thus inflate the implant. At least a portion of the spacer member has a dome surface received in a concave groove of the shell.

In another aspect, the spacer member may comprise a cam surface that cams relative to the other portion of the spacer member or to the occlusal cam surface of one shell. The cam surfaces can rotate relative to each other, resulting in inflation of the implant by camming the portion to expand. Again, at least some of these spacers have a dome surface that is received in a concave groove of the shell.

According to another aspect of the invention, the spacer member may be in the form of an internal cavity or canister. In one aspect, the cavity may be formed by a spacer member and a portion integral with one shell, such that the spacer member and the shell may expand relative to each other to expand the implant. In another aspect, the cavities may be formed by two parts of the spacer member that expand relative to each other and thereby expand the implant. In another embodiment, the cavity may be formed by the two end parts and the cylindrical wall of the spacer member such that the end part expands along the cylindrical wall to expand the implant. In any of these aspects, the spacer member can include an internal balloon to receive the injection material to capture the injection material in the cavity. Alternatively, the injection material may be press-fitted into the cavity to seal a portion of the cavity. A curable material can be used so that the expanded spacer member is rigid. Alternatively, the filling of the spacer member may be an elastomer or flowable material that can absorb some impact.

Various forms of the invention can be implanted through an anterior, anterior, or posterior surgical procedure. The size of each implant component or folded implant may be such that each can only be inserted into a small incision in the ring. In addition, the spinal structure allows insertion of components or folded implants only through the back of the spine. Access to the surgical site through the back reduces the procedure's invasiveness, and often allows one orthopedic surgeon or neurosurgeon to perform the procedure without the need for a general surgeon, thus substantially reducing the cost and complexity of the surgical procedure. To decrease.

In order to induce implantation and rotation of the implant, aspects of the invention include structures located in various parts of the implant for being held and manipulated by an inserter instrument. Such implant structures may include grooves and / or pillars that may be gripped by the inserter instrument. The inserter device preferably holds the implant in the desired insertion orientation, thereby generally preventing rotation of the implant relative to the inserter device. The grip of the inserter instrument can be adjusted during the implantation procedure to cause the implant to be rotated by the inserter instrument to the implant position in the nuclear space. This procedure includes inserting an implant oriented such that its minor dimension passes through the incision of the ring, wherein the implanted position is oriented such that the major size is at least partially extended along the incision of the ring (eg, Oblique angle), which may include minimizing the likelihood of departure of the implant through a small incision. That is, it would be difficult for the implant to escape from the ring by itself because it requires a rotational force to align the small size with the incision to escape from this orientation. That is, the main size of the implant is considered to be too large to fit through the incision without rotational action. Immediately after implantation, the inserter device is released from the implant.

In another aspect, the implant may have a structure for securing the implant part in a particular orientation for implantation as a monolith. Such implants may be formed as wedges to have an insert that allows for easy insertion of the implant into the ring. For example, the first implant part is provided with a groove, and the second implant part is provided with a protrusion received in the groove so that the groove and the protrusion are releasably connected to each other. When so connected, the implant is in the insert form, which can include having an insertion or leading end smaller than the trailing end. In this regard, the first and second implant parts are arranged to form wedge shapes or angles that are easily inserted between the vertebrae and into the nuclear space through the ring.

The connection providing the insertion form can be released immediately upon implantation, the restraint of the ring and / or the cone with the insertion force acting on the first and second implanted parts in the same manner as the leverage point to axially rotate the implanted parts, This releases the connection. Thus, the orientation providing the wedge shape for insertion may be a heteromorphic connection that may include interference fit between the connection structures. The interference pit can be formed at the leading end and work together in the direction in which the axially rotated end of the implant member moves as it moves toward or away from each other between the insert and the actuated forms.

The releasable connection may be a snap fit connection that holds the member in a certain general relative orientation during insertion and receives the protrusion in the groove until the insertion force against the implant by the vertebra releases the protrusion and the groove. That is, the implant can be converted from the insert form into the actuated form, specifically by release of the snap fit connection.

In one form, the releasable connection may be something like a dove-tail joint, where the protrusion is a z-shaped protrusion received in a groove having a complementary geometry. The z-shaped joint can be provided by snapping the z-shaped protrusion into the groove to form a snap fit, and also sliding the z-shaped protrusion into the groove through the opening at one end so that the z-shaped protrusion forms the groove and the interference pit, It may be provided by allowing release through snapping out.

In another form, the first and second implants form catches such that a vertebral contacting the outer surface of the implant acts as a lever point to release the catch to convert the implant from the insert to the operable form. It may have a structure of a leading end to. This catch may be formed by a protrusion from the first implant member that is received in a hook or barb on the second implant member.

In another form, the protrusion may be a tongue received in an opening angled to the plane of the member, and generally such tongue and opening may form a butt-joint. At the beginning of the insertion force the tongue escapes from the opening and releases and converts the implant member from insert to actuated form.

Since implants of various sizes and shapes can be provided, it is advantageous to examine the site of implantation, ie, the nuclear cavity, to properly select the geometry and size of the implant. To this end, a plurality of test spacers are prepared for removable insertion so that one or more test spacers can be sequentially inserted and removed until a suitable fit is determined. Such test spacers may be molded to be parallel to the implant form of the actuated form and may be molded to facilitate insertion through the ring.

Test spacers may be prepared to insert and remove test spacers used to measure nuclear cavities. Such test spacers may secure test spacers to the instrument such that the test spacers have a generally fixed orientation during insertion, and that the test spacers may rotate within the nuclear cavity in a manner similar to the implant. Fixation can be adjusted. Such test spacer devices may be adjustable and may include a fixable member, such as a screwed member for adjusting the fixation of the test spacer to the instrument, and a knob for securing in position. Alternatively, the test spacer mechanism may include a plurality of predetermined locations to which the test spacer is secured.

In the drawings, FIG. 1 is a first perspective view of an implant envelope, which is an aspect of the present invention.

FIG. 2 is a second perspective view of the envelope shown in FIG. 1.

3 is a first perspective view of the sheath comprising a dome surface.

4 is a second perspective view of the envelope shown in FIG. 3.

5 is a side view of the shell shown in FIG. 3.

6 is a perspective view of an implant that is an aspect of the present invention.

7 is a plan view of an implant with virtually spaced members.

8 is a side view of the implant shown in FIG. 7.

9 is a cross-sectional view of the implant shown in FIG. 7.

10 is a plan view of the insert and the sheath in the locked position.

FIG. 11 is a plan view of the insert and the sheath of FIG. 10 in an intermediate position.

12 is a plan view of the insert and the sheath of FIG. 10 in an open position;

13 is a perspective view of the insertion tool of FIG. 10.

14 is a perspective view of an implant comprising a curtain.

15 is a side cross-sectional view of the implant shown in FIG. 14.

FIG. 16 is a cross-sectional view of an implant with a wall that restricts the movement of the sheath in the front-rear or lateral direction and does not allow the spacer to detach.

17 is a perspective view of the implant shown in FIG. 16.

18 is a cross-sectional view of a spacer and implant having a circumferential structure to limit the movement of the sheath in the front-rear direction.

19 is a perspective view of the implant shown in FIG. 18.

20 is a perspective view of an implant having a channel for cable to limit movement of the sheath.

21 is a plan view of the implant shown in FIG. 20.

22 is a side view of the implant shown in FIG. 20.

23 is a perspective view of the spacer and implant in a partially virtual view.

24 is a cross-sectional view of the implant shown in FIG. 23.

FIG. 25 is a plan view partially illustrating the implant of FIG. 23. FIG.

26 is a perspective view of an implant with a helical insert.

FIG. 27 is a perspective view of the helical insert shown in FIG. 26.

28 is a perspective view of an implant with a rotating member leading to a wedge.

FIG. 29 is a cross-sectional view of the implant shown in FIG. 28.

FIG. 30 is a plan view partially illustrating the implant of FIG. 28. FIG.

31 is a partial virtual perspective view of a cam movable spacer and implant.

FIG. 32 is a cross-sectional view of the implant shown in FIG. 31.

33 is a cross sectional view of the inflatable canister and the first implant.

34 is a cross sectional view of the inflatable canister and the second implant.

35 is a side view of an artificial disc apparatus according to the present invention showing the upper and lower members releasably connected in an insert form.

36 is a side view similar to FIG. 36 except for the connection between the actuated member and the released member.

FIG. 37 is a partial cross-sectional view corresponding to FIG. 35 showing a member connected in insert form with an inserter mechanism for implanting an artificial disc device; FIG.

FIG. 38 is a partial cross-sectional view corresponding to FIG. 37 showing the grip member of the inserter mechanism extended relative to the grip axis to hold the artificial disc device for implantation.

FIG. 39 is a partial cross-sectional view corresponding to FIG. 38 showing an inserter mechanism secured to an implantable prosthetic device by an advancing grip member for retaining the lower member.

FIG. 40 is a partial cross-sectional view cut through lines 40-40 of FIG. 39 showing the grip post of the top member secured in a yoke shape. FIG.

FIG. 41 is a top view of the lower member of the artificial disc device of FIGS. 35 and 36 showing the groove at the leading end of the lower member and generally the outer track shape of the racetrack type.

42 is a side view of the lower member showing the dome bearing portion.

43 is a fragmentary bottom view of a lower member showing a portion of the wall and a wall facing the inserter mechanism during insertion.

FIG. 44 is a bottom view illustrating the grip member of the inserter mechanism secured to the lower member in the insertion orientation. FIG.

FIG. 45 is a bottom view of the grip member and the lower member corresponding to FIG. 44 showing the lower member rotated relative to the grip member placing the lower member in the ring.

46 is a plan view of the top member of the artificial disc device of FIGS. 35 and 36 showing the projection at the leading end of the top member and generally the outer track shape of the racetrack type.

47 is a side view of the top member showing the grip column and arcuate grooves secured by the inserter device during implantation.

48 is a side view of the top member showing the z-shaped protrusion at the trailing end of the top member.

FIG. 49 shows a spinal zone comprising an artificial disc device secured to an implantable insert device and an annular intervertebral disc ring.

FIG. 50 is a partial cross-sectional view of the spinal region of FIG. 48 showing insertion of an artificial disc device in the form of an insertion;

FIG. 51 is a partial cross-sectional view corresponding to FIG. 50 showing a member in operative form in the nuclear zone.

FIG. 52 is a cross sectional view taken along lines 52-52 of FIG. 51 showing an artificial disc device transitioned from an insertion orientation to an implant orientation.

53 is a side view of the inserter mechanism according to the present invention.

FIG. 54 is an exploded perspective view of the inserter mechanism of FIG. 53 showing the grip member securing the inserter mechanism to the artificial disc device;

55 is a cross sectional view of an alternative artificial disc device showing a dome member different from the top and bottom members.

56 is a cross sectional view of an alternative artificial disc device with replacement connections between the upper and lower members.

57 to 60 are plan and side views showing the replacement structure of each end of the lower member (FIGS. 57 and 58) and the upper member (FIGS. 59 and 60) for forming the releasable connecting portion therebetween.

Figure 61 is a side cross-sectional view of a test spacer having a test spacer at its end in accordance with the present invention.

62 is an exploded perspective view of the test spacer of FIG. 61.

FIG. 63 is a perspective view of the test spacer of FIG. 61.

64 is a side view of the test spacer of FIG. 63.

65 is a side view of a replacement test spacer with a replacement adjustment mechanism.

FIG. 66 is an exploded perspective view of the test spacer of FIG. 64.

67 is a flowchart illustrating a method of preparing for implanting an artificial disc device into the spinal cord in accordance with the present invention.

68 is a flow chart illustrating a method of implanting an artificial disc device into the spinal cord in accordance with the present invention.

69 is a side view of the trailing distal end of an artificial disc device with an vertebral lordosis angle that can be operated.

FIG. 70 is a side view of the insertion end of the artificial disc device of FIG. 61 showing the vertebral metastatic angle that can be operated; FIG.

FIG. 71 is an exploded view of the artificial disc device of FIG. 69 showing the top and bottom members; FIG.

Detailed Description of the Preferred Embodiments

Referring now to the drawings, one aspect of the implant device 10 includes an upper sheath 12 and a lower sheath 14. As used herein, the terms upper envelope and lower envelope are merely reference expressions of the illustrated shell arrangement, which arrangement may be reversed. The implant 10 is an artificial nuclear implant for replacing the nucleus of a damaged natural spinal cord. The nucleus of the natural spinal disc is usually removed following a procedure known as nucleectomy, which involves making an incision in the ring around the nucleus, at which time the nucleus is substantially removed. Typically, a small amount of viscous nuclear material remains in the disc space, which can be used to provide an interface that reduces possible pressure points due to incompatibility between implant 10 and the end plates of adjacent vertebral bodies.

One aspect of the implant 10 is inserted through the incision of the ring to keep the implant 10 in an intervertebral position in the nuclear space while the ring remains attached to the adjacent vertebral body. In order to use the loop in this manner, the implant 10 can be inserted into a component or part, or in a compressed or unexpanded state or arrangement. On site or upon implantation, the implant 10 may be assembled or inflated or expanded with assembly as described below. Thus, the incision of the ring is smaller than that required by a typical nuclear implant, and this surgery is minimally invasive. Since the size or arrangement of the implant 10 changes after it is inserted through the ring, the expanded or assembled implant 10 cannot be released from the ring. The use of rings to prevent extruded or escaped implants eliminates the need for protrusions or other anchorages that penetrate, strip, or otherwise disturb the complete surface of the end plate. By retaining the rings, the stability of the vertebral zone can be increased and restored closer to normal movement, minimizing the wound site from removal of the rings or other excessive damage.

Each sheath 12, 14 has an outer surface 20 which engages and engages an adjacent vertebral body (not shown), in particular the end plate of the vertebral body. The outer surface 20 of each shell 12, 14 is preferably flexible to prevent disturbance of the end plate surface. The end plates of adjacent vertebrae have naturally occurring recesses that engage the outer surfaces 20 of the sheaths 12, 14. The vertebrae above the implant 10 differ slightly from the vertebrae below the implant 10. The outer surface 20 of each shell 12, 14 is preferably the contour of the convex surface 18 corresponding to the concave surface of each adjacent vertebral body (see eg, FIGS. 26, 33, 34). In one aspect, the radius of curvature of the convex surface 18 present on the outer surface 20 of each shell 12, 14 is consistent with the radius of curvature of the adjacent vertebral body. In another aspect, the radius of curvature of the convex surface 18 present on the outer surface 20 of each shell 12, 14 is slightly less than the radius of curvature of the adjacent vertebral body. Since the bones of the end plates are slightly elastically deformable, a slight mismatch between the outer surface 20 of the shell 12 and 14 and each vertebra prevents the movement of the shell 12 and 14 relative to the vertebra. To give some residual pressure. As another alternative, the radius of curvature of the convex surface 18 present on the outer surface 20 of each shell 12, 14 may be slightly larger than the radius of curvature of the adjacent vertebral body. In other words, because the bones can deform slightly elastically, the slight excess iron on the lateral side distributes the compressive force on the implant and adjacent vertebra more evenly. All such mismatches should not be such that bone drop occurs, as described above.

Each shell 12, 14 preferably has an outer circumferential form 26 of an oval or racetrack shape with a transverse size D1 greater than the longitudinal size or the front and back size D2. Alternatively, each shell 12, 14 may be trapezoidal, circular or kidney (see FIGS. 31 and 32). In addition, the circumferential shape 26 can be circular or radial. In order to most uniformly distribute the compressive forces formed along the end plates by the implant 10, it is desirable to cover the end plates in the nuclear space as alternately as possible in size and shape 26 of the shell 12, 14. Do. In addition, it is preferable that the outer circumference 26 of the shells 12 and 14 is placed in contact with at least a portion of the inner surface of the ring to be implanted as described below.

Each implant 10 has at least one multiaxial articulated bearing member 30 formed between a concave groove 40 formed in the upper shell 12 and a dome surface 50. The surface of the dome surface 50 and the groove 40 that mates with the dome surface 50, as well as another sliding surface described herein, is preferably flexible to lower the fastening friction. As shown in FIGS. 1 to 5, the groove 40 is formed on the side 42 (FIG. 2) opposite the lower sheath 14, and the dome surface 50 is the lower side opposite the upper sheath 12. It is formed on the surface 52 (FIG. 4) of the shell 14. Alternatively, as shown in FIG. 6, the implant 10 has a pair of multiaxial articulated bearing members 30, wherein the spacer member or insert 60 is faced with the shell 12, 14, respectively. And opposing surfaces 62 and 64, each comprising a dome surface 50 received in a concave groove 40 present therein. As another alternative, FIGS. 7-9 illustrate a spacer 70 having large surfaces 72, 74, the facing surface 72 comprising a dome surface 50, the facing surface ( 74 includes a flat portion 76. For the spacer member 70, the dome surface 50 is received in the groove 44, and the flat portion 76 is in the groove 78 of a similar shape (slightly larger) to the flat surface of the lower sheath 14. Received, the flat portion 76 can slide or translate in the groove 78. Two wear surfaces reduce the total wear rate that is formed compared to a single wear surface, so two wear surfaces are preferred. Note that the radius of curvature of the opposing faces of the spacer 60 with two wear faces need not be the same.

Each articulated bearing member 30 between the dome surface 50 and the groove 40 provides multiaxial movement of the concave groove 40 relative to the dome surface 50. In particular, the bearing member 30 enables bending / extension, lateral bending and rotational movement of the groove 40 relative to the dome surface 50. In addition, the occlusal surface between the debris member 60 and the sheaths 12 and 14 provides relative sliding or translation, respectively, as described below. The stiffness of the articulated bearing member 30 can vary or be adjusted. In particular, the concave groove 40 and the dome surface 50 each have a respective radius of curvature. If the radius of curvature of the groove 40 is greater than the radius of curvature of the dome surface 5, the stiffness decreases. If the radius of curvature of the groove 40 is less than the radius of curvature of the dome surface 50, the stiffness increases.

In order to more closely mimic the behavior of the natural disc nucleus, the sheaths 12, 14 and all of the spacer members, such as but not limited to the spacer members 60, 70, can slide or move relative to one another. The groove 40 and the dome surface 50 can rotate or axially rotate relative to each other as well as slide along the occlusal surface. For example, in the case of the flat portion 76 and the flat surface of the groove 78, the slide is translational. The natural disc contains the nucleus of a viscous fluid, which fluid moves in a direction opposite to the nuclear compression or bending direction. The sheaths 12 and 14 of the implant 10 move in accordance with the vertebral movement. However, the spacer 60 extends in the opposite direction of bending and cannot be pressed in the bending direction as in the case of natural discs. Thus, when the spacer 60 slides or translates relative to the sheaths 12 and 14, the spacer 60 can be displaced from the bending direction and thus more accurately resembles the compression of the natural nucleus. have. Also, if the height of the implant 12 is small, the axial point of the upper sheath 12 relative to the lower sheath 14 will be below the lower sheath 14. Thus, it is preferable that the groove 40 of the upper shell 12 moves along the dome surface 50 such that the axial point moves along the upper shell 12.

Similarly, the center of rotation in all the cone-disc-cone segments changes slightly during bending / extension movements. To this end, the radius of curvature of the groove 40 may be greater than the radius of curvature of the dome surface 50 in the front-rear direction. Thus, the dome surface 50 can slide relative to the groove 40 in a manner that can move the center of rotation.

As noted above, the implant 10 may be inserted into a part, specifically, subsequently or continuously. As shown in FIGS. 1 to 5, the implant 10 has two main parts, an upper sheath 12 and a lower sheath 14, where the upper sheath 12 is a dome of the lower sheath 14. It has a concave groove 40 to receive the surface 50. As shown in FIG. 6, the implant 10 has three main parts: upper and lower sheaths 12, 14 and spacer 60, where sheath 12, 14 is a spacer ( It has a concave groove 40 which receives a dome surface 50 present on opposing surfaces 62, 64 of 60. 1-6, at least one of each shell 12, 14 includes a slope 90 adjacent each groove 40. The slope 90 may have an arcuate profile with respect to the cam moveable dome surface 50. Regardless of the order in which the sheath 12, 14 or spacer 60 is inserted through the incision of the ring, the slope 90 cams any dome surface 50 with respect to the aligned slope 90 during insertion. Operatively push the components together so that the dome surface 50 can be cam-moved relative to the aligned slope 90. In this manner, the size of the incision performed in the annulus can be minimized as needed to insert the largest part, which annulus can serve to hold the implant 10 in the nuclear space.

In order to further minimize the size of the incision made in the annulus, the sheath 12, 14 whose anterior and posterior size D2 is smaller than the transverse dimension D1, with the shorter side end 16 first through the rear incision of the annulus. Can be inserted to enter The maximum removal rate that is necessarily provided by the incision of the ring is only enough for the largest of the three parts. That is, the incision forms a deformable life preserver or recoil loop, and each component or part of the implant 10 forms the minimum encirclement required for the incision to allow passage. Part of the use of the instrument may include a device for making a precise incision in the ring that is only large enough to insert the implant. This incision only needs to be large enough for the largest of the minimum envelope sizes of each component. Immediately after implantation, any spacer, such as sheath 12, 14 and / or spacer 60, may rotate in nuclear space such that the short size D2 is not aligned with the ring incision.

The sheath 12, 14 and the implant 10 may be rotated by the insertion instrument 110 generally during insertion or after assembly in the nuclear space (see FIGS. 1-6 and 10-13). The sheaths 12, 14 may generally have pillars comprising a circular outer surface 102 and at least one flat portion 104 formed in the outer surface 102. As shown in FIGS. 10-13, the instrument is in various positions and has an upper stop jaw and a lower jaw 14 capable of reciprocating along the longitudinal axis of the instrument 110. Referring to FIG. 10, the lower jaw 114 of the instrument 110 is adjacent or facing the flat portion 104 such that the pillar 100 is fixed in the jaws 112, 114, and the instrument 110 and the pillar 100. ) Is in a locked position with respect to the insertion of the sheath (12, 14). As can be seen in FIG. 11, the lower jaw 114 is in an intermediate position, slightly backing away from the column 100 such that the lower jaw 114 does not abut or face the flat 104. In this intermediate position, the column 100 is still held in the jaws 112, 114. However, the column 100 can rotate relatively within the jaws 112, 114, so that the shell 12, 14 can rotate during or after insertion into the ring. 12 also shows the displaced position, where the lower jaw 114 is pushed behind the column 100 so that the instrument 110 can be removed from the column 100 and removed from the implantation site. As shown, the pillar 100 expands away from the attached sheath 12, 14. Jaws 112, 114 have opposing walls 115, 116, respectively. These walls 115, 116 are formed to conform to the contours of the jaws 112, 114, providing grooves 117, 118 between the walls 115, 116. That is, the jaws 112 and 114 can simultaneously enclose and manipulate a pair of pillars 100 present on the pair of shells 12 and 14 in the manner described. The grooves 118 between the walls 116 of the jaw 114 open end so that the lower jaw 114 can move along the circumference of the column 100 in a row to reciprocate between the locked, intermediate or open positions. Retains end 119.

As described above, the sheaths 12 and 14 of the implant 10 may be shaped like natural nuclei, whereby the outer periphery 26 of the implant 10 extends adjacent to a portion of the ring to create tension in that portion of the ring. You do not have to be present. However, as found, tension on the ring relieves pain and improves stability of the intervertebral joint. As shown in FIGS. 14 and 15, an outer curtain of the same shape as the corrugated bellows 120 is secured to the sheath 12, 14. This bellows 120 may seal between the sheaths 12 and 14 and may be expanded to allow for injection of material into the implant 10. The injection material may be a gas or a liquid or other flowable material, and the bellows 120 expands accordingly to apply pressure inside the ring. In particular, the bellows is preferably filled with saline or other non-oily materials. In addition, the infusion material may slightly inflate the implant 10 to provide some shock absorption and, if necessary, additional elongation. Furthermore, the bellows 120 prevent impurities from entering the implant 10 that may impede or degrade the performance of the articulated bearing member 30. In some embodiments, the injection material may be a hydrogel pellet and the bellows 120 may comprise a permeable or semi-permeable portion that can absorb the fluid. When using pellets, the injection material can move within the implant 10 as any bearing member 30 articulates between the sheaths 12 and 14. Inflating the bellows 120 or similar structure, pressure is applied radially to the rings, causing the rings to be tensioned.

The bellows 120 may be attached to the shell 12, 14 in a number of ways. For example, thermal bonds, adhesive bonds, or compression seals can be used to firmly and permanently bond the bellows to the shell 12, 14. When the bellows 120 is pressed, some may deflect outward. Therefore, the compliance of the bellows 120 is lower in the rearward direction than in the front-side direction so that the deflection is minimized toward the spinal cord when the bellows 120 deflects outward. As used herein, the term compliance refers to the property of a material's extension. Bellows 120 may have an inlet 122 to which a catheter or needle may be attached, which is used to inject into bellows 120, which includes a sealing mechanism.

As discussed earlier, the maximum angle of deflection between the vertebrae in the natural disc is about 15 °. The expanded transverse size D1 of the sheaths 12, 14 limits the side bending to 15 °. However, it may be necessary to limit the back and forth bending of the implant 10. As can be seen in FIGS. 16 and 17, the sheaths 12, 14 include short walls 130 that extend toward each other so that the walls 130 abut when they reach a 15 ° bend. Alternatively, as can be seen in FIGS. 18 and 19, the spacer 140 has an outer shell such that the faces 42, 52 of the upper and lower shells 12, 14 contact the ring 142 when the 15 ° angle is reached. And a ring ring 142 extending from the outer circumference of the spacer member between 12 and 14. Ring 142 may be made of a softer material than sheaths 12 and 14 to minimize wear and may be elastically pressed. The size of the short wall 130 and the ring 142 can be adjusted to a specification to provide or limit the movement of the shell 12, 14 at an angle, such as 15 °, or another desired angle.

In another embodiment, shown in FIGS. 20-22, each shell 12, 14 includes two pairs of ports 150, each port 150 having a port 150 of opposite shells 12, 14. Generally aligned, each pair includes a grooved channel 152 on the outer side 20 of the shell 12, 14 to connect the pair. A cable or cable segment (not shown) is inserted through the port 150 and the channel to be embedded from the outer surface 20 of the shell, thereby allowing the cable to form a closed loop. In this way, the sheath 12, 14 surfaces opposite the bending direction can only be separated to the extent provided by the length of the cable. Such cables should be of a length such that the degree of separation between the sheaths 12 and 14 does not exceed 15 ° or any other angle in the fore and aft directions. In addition, the cable arrangement prevents the sheaths 12 and 14 from being separated from each other, and blocks the space between the sheaths 12 and 14 so that the spacer 60 therebetween becomes loose and can escape from the sheaths 12 and 14. Do not have.

Referring now to FIGS. 23-25, the implant 10 has upper and lower sheaths 12, 14 and stepped spacers 160. Lower envelope 14 preferably includes an inclined stepped slope 162 with staircase 164 aligned in the front-rear direction and sidewalls 166 to the side of staircase 164. The staircase 164 ascends toward the center of the shell 14, and the dome surface 50 contacts and is received in the groove 40 at the opposite surface of the spacer 160. Sheaths 12 and 14 may be inserted into the nuclear space in which stepped slopes 162 are aligned with the ring incision. In one form, the dome surface 50 of the spacer member 160 can cam cam relative to the upper shell 12 while being pressed into the nuclear space between the shells 12, 14. The stepped spacer 16 may be press-fitted between the shells 12 and 14 such that the member cams with respect to the stairs 164 and steps up. The sidewall 166 is arranged to prevent excess translation while the spacer 160 can slide or translate within a short distance in the front-rear direction along the stairs. Once the stepping spacer 16 is inserted, the casing 14 may be rotated such that the slope 162 is no longer aligned with the ring cutout. To prevent the spacer 160 from returning to the bottom of the implanted stepped slope 162, a stop (not shown) is mounted, or the step 164 is inclined downward toward the center end of each step 164. And the bottom surface of the staircase 164 and the stepping spacer 160 are engaged as shown. Alternatively, the lower sheath 14 including the stepped slope 162 may be inserted, and then the spacer 160 and the upper sheath 12 may be inserted together with the dome surface housed in the concave groove 40. Thus, the spacer 160 and the upper sheath 12 are pressed together into the nuclear cavity such that the spacer 160 steps up the stairs 164 of the lower sheath 14. Alternatively, the upper and lower sheaths 12 and 14 and the stepped spacer 160 may be inserted together such that the spacer 160 is located in the lower staircase 164, in which case the implant is a nuclear cavity. It shall be of reduced size or thickness during insertion.

Referring to Figures 26 and 27, the implant 10, which is inserted in a folded or pressed state or arrangement and then expanded, has upper and lower sheaths 12 and 14 and a spiral stepping spacer 170. . Two shells 12, 14, preferably one shell 12, 14 have concave grooves 40 for receiving a dome surface 50 formed in the spacer member 170. The spacer member 170 has two opposing stepped spiral wall zones 172. In some forms, one of the spiral wall zones 172 is integral with one of the sheaths 12, 14, and in some other forms a concave groove in the sheaths 12, 14, where the two helix wall zones 172 respectively occlude. Dome surface 50 received by 40. Spiral wall zone 172 holds staircases 174 in opposing spiral arrangements. The implant 10 is inserted into or assembled in the nucleus of the pressed arrangement in which the spiral wall regions 172 are completely engaged with each other. Once inserted, the spiral wall zones 172 can rotate relative to each other, such that the opposite steps 174 of the spiral wall zones 172 step up relative to each other to expand the implant 10 in an expanded arrangement. Let's do it. Implant 10 may be configured such that spiral wall zone 172 is prevented from undesirable relocation. As with the implant 10 described above having a stepped slope 162, the staircase 174 of the spiral wall zone 172 can be inclined toward the direction of rotation for expansion to prevent or hinder repositioning, or a stop ( Not shown) can be mounted. As another alternative, the implant 10 automatically opens and rotates in an expanded arrangement after the spiral wall zone 172 is implanted, and the spiral wall zone 172 then expands the sheath 12, 14. Compression and / or twist springs (not shown) may be mounted to hold them in place.

As another alternative, FIGS. 28-30 rotate around the longitudinal axis 182 connected to the upper and lower sheaths 12, 14 and a pair of opposing wedges 184 and a pair of hemispherical members 186. Shows an implant 10 having a spacer 180 comprising a). Each hemispherical member 186 includes a dome surface 50 that is received in a groove 40 of each shell 12, 14. Rotating member 182 is fitted within wedge 184. As the rotating member 182 rotates in a particular direction, the wedge 184 is forcibly guided from the pressing arrangement in which the wedge 184 is separated from the wedge 184 to an expanded arrangement in which the wedges 184 are closed together or adjacent to each other. The wedge 184 of the pressing arrangement is generally located laterally with respect to the space 186 between the hemispherical members 186. Rotating rotating member 182 to close wedge 184 pulls wedge 184 to a position within space 186. In this way, the wedge surface 188 is adjacent to the hemispherical member 186, the hemispherical members 186 are away from each other, and the implant is in an expanded arrangement. The implant 10 may be inserted in a compressed arrangement and then inflated as described above. Alternatively, a single wedge may be used with a rotating member that is rotatably secured to the sheath or hemispherical member, or inflate the implant by forcing the wedge away from one another as opposed to indenting the wedge into the interior as described above. You may. The distal end of the rotating member 182 used to rotate is preferably disposed to face the incision during rotation.

Referring now to FIGS. 31 and 32, an implant 10 having a spacer in the form of a cam member 200 and a cam surface 202 is shown. This implant 10 is inserted in a compression arrangement and then the cam surface 202 rotates to inflate the implant 10. Cam member 200 includes a cam moving dome 204 in which dome surface 50 is received in groove 40 of upper sheath 12. The cam movement dome 204 preferably has three or more cam surfaces 202 that mat with the opposing cam surfaces 202 of the lower sheath 14. In the pressed or unexpanded arrangement, the cam surface 202 and the lower sheath 14 of the cam moving dome 204 are fully engaged. The cam movement dome 204 can rotate relative to the lower sheath 14 such that the occlusal cam surface 202 can cam cam relative to each other, such that the cam movement dome 204 is raised and the implant 10 Expands from the press array to the expansion array. At the highest point 204 of the cam surface 202 of the lower sheath 14 there is a hump or other stop which can be installed on the cam surface 202 to prevent the cam dome 204 from returning to the lower position. do. Alternatively, a pair of cam movement domes 204 can be provided by positioning the cam surface 202 therebetween, where the cam movement domes 204 can rotate relative to each other to expand the implant 10. .

As an alternative embodiment of the expandable implant, FIGS. 33 and 34 illustrate the implant 10 having upper and lower sheaths 12, 14 and an expandable canister. In FIG. 33, the canister 220 has an upper cap 222, a lower cap 224, and sidewalls 226. The upper cap 222 and the lower cap 224 each hold a dome surface 50 that mates with a groove 40 in each shell 12, 14. The implant 10 is inserted into the nuclear space in a pressurized or unexpanded arrangement, and the sheaths 12 and 14 receive annular grooves 230 that receive the sidewalls 226 when the implant 10 is in a pressurized arrangement. Hold. Sidewall 226 includes an inlet 232 for injecting a flowable material into canister 220 to expand canister 220, thereby expanding implant 10 in an expanded arrangement. Sidewall 226 has inner expandable ribs 234 at the upper and lower edges, which are outer expandable ribs 234 over each cap 222, 224 when canister 220 is fully inflated. Conflict with Referring to FIG. 34, an alternative canister 240 is shown in which the lower cap 224 is integral with the sidewall 226. Canister 220 may preferably be filled with a curable material to prevent leakage from expanded canister 220. In this embodiment, the caps 222, 224 must form sufficient seals with the sidewalls 226 so that the fill material can be retained in the canisters 220, 240. As an alternative, one of the caps 222, 224 may be integral with one of the sheaths 12, 14.

Alternatively, canister 220 may be filled with an elastomeric material or filled with fluid to allow for some degree of shock absorption. As another alternative, the balloon 250 may be used instead of the canisters 220, 240. If only a balloon is used, the retracted balloon may be pre-placed in the shell 12, 14 when the implant 10 is inserted into the nuclear space, or the retracted balloon may be inserted after the envelope is implanted. In order to fill the balloon 250, a port or inlet that can receive an injection from a catheter or the like must be provided in a position aligned with the inlet 232 of the sidewall 226. If the catheter is removed after filling the implant, for example, the balloon or canister must be sealed. Thus, a self-sealing valve or valveless connection is preferably present between the injection device and the instrument or canister. Alternatively, the injection material may seal the balloon or canister, such as when the injection material is curable. When the balloon is used with the side wall 226, the function of the side wall 226 is to limit or reduce the side deformation of the balloon such that the height of the implant 10 is maintained.

If balloon 250 is enclosed in another structure and is generally used without being immobilized and filled with a non-curable material, non-compliance or minimal compliance balloons can be used to maintain stiffness during bioloading. The balloon can be filled with, for example, saline, silicone oil or PEG solution. If the balloon is filled with a curable material, the balloon can be made of either compliant or non-compliant material. Suitable curable materials include, but are not limited to, PMMA, calcium phosphate, polyurethane, and silicone.

In some forms of intumescent implants, properties are provided to control the degree of inflation. For example, the wall section 172 of the spirally stepped spacer 170 may rotate to a desired height, or the expansion of the canister 220 may be controlled by adjusting the amount of injection material. The height or inflation of the implant 10 and the stretching force on the vertebra can also be monitored and adjusted. However, from a clinical point of view, the implant 10 preferably expands to a predetermined stretch force such that expansion occurs with respect to the contact pressure of the vertebral end plates.

Each multi-axis bearing member 30 as described herein has an outline that mates with a similarly shaped groove. The appearance of the dome surface may be partially oblong, hemispherical, or similar, but it should not be overlooked that other shapes, such as elliptical or parabolic, may function more predominantly. This change in dome surface shape can be used to provide a different range of motion to the multi-axis bearing member 30. As shown, the spacer has one or two arcuate dome surfaces with a radius of curvature, which can be unreasonably large for use in intervertebral space if such dome surfaces must form a complete oblong shape. Alternatively, the spacer member may be provided as a rigid ball or a semi-rigid arcuate ball.

In particular, it is advantageous for the dome surface and groove bearing member 30 to form an interface between the spacer member and the shell, which allows a great degree of freedom so that the shell is relatively oriented when implanted. Specifically, the sheath may be oriented at an angle appropriate to the various intervertebral disc levels as described above. For example, at various levels, such as the L5 / S1 level, the vertebrae are oriented at an angle that allows the spine to maintain only vertebral shape. By freely rotating the shell relative to the bearing member, the shell can be angled in accordance with the natural curvature of the spine without creating an uneven pressure distribution on the end plate of the vertebral body.

Materials used in any spacer such as sheath 12, 14, and spacer 60 may be selected to provide characteristic properties. The components of the implant may be coated with polyurethane to reduce damage to surrounding tissues during implantation and to reduce polishing during micromovement between surrounding tissues and components in situ. The material may be chosen to provide the desired wear properties between the slide surfaces and may be selected to provide radiotransmittance. In any case, the material for the sheath 12, 14 and the material of any component of the articulated bearing member 30 are generally rigid, such that the implant 10 is implanted 10 as a natural disc experiences. It must be able to support the cyclic pressure load by Some examples of such materials are metals, ceramics, plastics, composites and elastomers. Metals may include surgical grade stainless steel, Co-Cr alloys, liquid metals, titanium and titanium alloys. Ceramics may include alumina and zirconia. Plastics may include polyethylene, polypropylene, pyrolytic carbon, PEEK ™ and BioPEKK ™. Composites may include carbon fiber PEKK and carbon fiber BioPEKK. Elastomers can include polyurethanes. Nonmetallic materials are radioactive and are advantageous because they do not generate artifacts during imaging such as radiographs, magnetic resonances or CAT scans. In the case of using a non-metallic material, it may be advantageous to provide a radiopaque marker to the device to aid in the identification of the image. For example, one or more markers may be provided for each envelope to allow for observation of each orientation and location, and the markers may be different in size so that the markers of each envelope can be distinguished and recognized. For example, each individual member of the implant may have a marker of non-uniform form or two transverse markers of different sizes or shapes such that the markers clearly show the position and orientation of each member when viewing the image. It should be borne in mind that the foregoing materials are merely examples and do not categorize the entire list of materials that can be used.

The spacer member and the shell may be made of a conformable material, or may be made of different materials. In general, the use of non-metallic materials as sheaths may be advantageous to use non-metallic materials of the spacer member in order not to generate artifacts during imaging. However, the use of metallic materials on wear surfaces can increase wear resistance on articulated and sliding surfaces.

Referring now to FIGS. 35-50, additional aspects of an implant or artificial disc device 300 are shown. The implant 300 may be made up of two parts comprising an upper member or shell 314 and a lower member or shell 312 having respective outer surfaces 320 and 322 in contact with the end plates of adjacent vertebral bodies. . As in the previous aspect, the convex or concave surfaces of the outer surfaces 320, 322 of the implant members 312, 314 may be coherent or slightly inconsistent with the contours of adjacent vertebral bodies. The outer surfaces 320 and 322 may also be flat, one flat, convex or concave, and the other vice versa. In addition, as in the previous aspect, the outer surfaces 320 and 322 preferably do not need to have protrusions or the like for securing the implant to the end plate, but may sometimes be retained.

In order to allow the graft members 312 and 314 to move relative to each other, a bearing interface between the graft members 312 and 314 through a portion or bearing member of the graft members 312 and 314 as described in the previous aspect. 315). More specifically, the lower member 312 has an arcuate or dome bearing portion 319 that may be shaped substantially conforming to the grooved bearing portion 317 of the upper member 314. For the sake of clarity, the groove 317 and the dome portion 319 may be oppositely formed in the lower member 312 and the upper member 314, respectively. In addition, the dome bearing portion 319 may be mismatched with the grooved bearing portion 317 to provide the desired degree of joint stiffness as described above. Also, the movement can be limited to one axis, two axes or multiple axes. For example, a motion limiter (not shown) may be provided over the implant members 312 and 314, or a uniaxial joint may be formed with a bearing member having an elongate concave or convex surface.

Thus, like the bearing member 30 described above, the dome bearing portion 319 conforms to the arcuate groove 317 such that each surface 319a and 317a rotates or axially slides in sliding contact, preferably substantially flat to each other. They must rotate and slide or translate relative to each other in an arcuate fashion. The relative movement between these skin members 312 and 314 is similar to that described for the other implants described above. Thus, the term bearing member as used herein may be the lower member 312, the upper member 314 or both bearing portions, or as separate components disposed between the lower and upper sheath members as described above. have.

The implant 300 is inserted between adjacent lower and upper vertebrae with the skin members 312 and 314 preferably connected to each other, as described below. The implant 300 and the sheaths 312 and 314 are of the racetrack type described above, wherein the front and back size D2 is smaller than the transverse size D1 and includes the sides 303a and 303b. The implant 300 is advantageously inserted using a smaller (D2) narrow lead or forward end 304. The implant 300 has a longitudinal axis that extends from the leading ends 304a, 304b to each subsequent end 306a, 306b, and a lateral axis that extends between the significantly longer sides 303a, 303b. The longitudinal and lateral axes of the implant members 312 and 314 generally mean their respective planes. In conclusion, the cutout 308 of the ring 309 should be of sufficient length to pass the lateral width D2. During or after insertion, the implant 300 is inserted such that the small transverse size D2 is no longer precisely aligned with the incision 308 so that the large transverse size D1 is associated with the post-transplant incision 308. It may be rotated to be at least partially aligned. In this manner, the size of the incision 308 that is performed in the ring 309 for insertion is minimized. In addition, by rotating the implant 300 in the nuclear space, the implant is captured in space by the ring 309 and is a smaller incision generally aligned with the adjacent longer sides 303a, 303b of the implant. There is no possibility of departure from 308.

In the case of the preferred oval or racetrack type, the leading end 304 of the implant 300, in particular the ends 304a, 304b of the disc sheath member 312, 314, is easily inserted through the incision 3087. The main plane of the member is bent. On the other hand, once the implant 300 is inserted, and the substantially long sides 303a, 303b of the implant 300, specifically its implant members 312 and 314, are rotated to align with the incision, the substantially long Due to the sides 303a and 303b and their length, the disc members 312 and 314 are very unlikely to escape through the incision 308 after implantation. Moreover, in a preferred embodiment of the present invention the substantially long sides 303a, 303b are generally straight, thereby increasing resistance to detachment of the implant members 312,314.

As described above, one member is already inserted into the nuclear space between adjacent vertebrae 321 and the other member is inserted through the slope 90 in a form that can operate relative to the already inserted member. If continuous insertion is desired, an optional slope 90 may be provided to facilitate alignment of the implant member. On the other hand, the preferred disc device 300 may be inserted as a single unit such that the members 312 and 314 are inserted together through the ring cutout 308. Thus, an alignment structure for implanting the skin members together in an operable form into the vertebral disc space, such as the slopes described above, is not necessary. In this regard, the upper member 314 may have a flat portion 390 on the general side of the upper member on either side of the arcuate groove 317.

The artificial disc members 312 and 314 are preferably connected to one another, so that the disc device 300 can be inserted as one unit or disc assembly as described above. To this end, the disc members 312 and 314 are connected to look like an insert that allows for effective implantation of the disc assembly 300 while minimizing its invasiveness in terms of the incision size required for the ring 309. 47 and 50, the insertion form of the disc unitary body 300 is preferably in the form of a wedge such that a small outline is formed at the leading end 304 of the unitary body 300. As shown in FIG. At the subsequent end 306 of the monolith 300, the disc members 312 and 314 are tapered together so that the subsequent end 306 has a larger contour than the leading end 304.

Thus, this form of insertion of the artificial disc assembly 300 first inserts the leading end 304 through the narrow narrow incision 308 formed in the fibrous annular material while maintaining minimal resistance to the initial stage of implant insertion. Makes it possible. Continuous insertion of the monolith 300 causes the incision 308 to open so that the entire implant 300, including the enlarged subsequent end 305, fits into the nuclear space 311. Implant members 312 and 314 The bearing portion or interface 315 therebetween acts as the lever point between the members 312 and 314. The force exerted on the upper and lower surfaces 322 and 320 during the initial insertion is the bearing of the bearing portion 315. When the implant 300 enters the annulus 309, the force increases not only in front but also acts on most of the surfaces 320, 322 as it enters the annulus 309. The force exerted at the rear of the lever point of the members 312 and 314 will at some point exceed the force exerted at the stern of the lever point sufficient to allow the implant member 312 and 314 to move into an operative form. As such, the wedge insertion form inserts the leading end 304 of the implant 300 and It helps to effectively move the disc device 300 in operative form in the nuclear space 311 between adjacent upper and lower vertebral bodies 321 and specifically its end plates.

More specifically, each axis 312a and 314a of the disc members 312 and 314, together with the length of the disc members 312 and 314, has an insertion wedge angle ω that governs the degree of separation of subsequent member ends 306a and 306b. Form. In order to maintain the insertion form of the disc apparatus 300, the disc member 312,314 is formed with the releasable connection part 340 between each lead end 304a and 304b. This releasable connecting portion 340 places the disc members 312 and 314 in insertion form under a predetermined insertion wedge angle ω formed therebetween. According to a preferred exemplary form, the releasable connecting portion 340 works with the dome bearing portion 319 and the groove portion 317 of each member 312 and 314 to form the insertion wedge angle ω of the particular disc monolith 300. .

41 and 42, the lower member 312 includes a groove 344 formed at its distal end, which groove 344 is the distal end of the disc member 312 from the leading end 304a with respect to the main plane. It extends obliquely upward in the direction extending toward 306a. The protrusion 342 corresponding to the groove 344 is provided in the upper member 314 and has a form extending into or parallel to the main plane of the member 314. In this manner, the disc members 312 and 314 are releasably attached by receiving the protrusion 342 in the groove 344, and the upper member 314 is tilted upward with respect to the plane of the lower member 312. Could be. In addition, the bearing portions 317 and 319 can work together such that the members 312 and 314 are releasably attached such that the upper member 314 is fastened to the lower member 312 and supported by the lower member. Specifically, the groove bearing portion 317 of the upper member 314 at the rear of the releasable connection 340 will be located in front of the upper member bearing portion 319 (see FIG. 35).

The releasable connection portion 340 maintains the disc members 312 and 314 attached together when the disc device 300 enters the vertebral disc space 311 at the initial insertion stage through the ring incision 308. Should be of sufficient strength to make As noted above, the shells 312 and 314 preferably have cooperative structures such as protrusions 342 and grooves 344 that releasably secure the shells 312 and 314 in the desired wedge angle orientation. In a preferred exemplary form, the releasable connection 340 is in the form of a hindrance or snap-fit connection, such as a z-shaped connection 340 located at the leading end portions 304a, 304b of the sheath 312, 314. In this regard, the upper sheath 314 includes protrusions of the z-shaped protrusion 342 shape, and the lower sheath 312 includes the occlusal grooves 344 that are formed to substantially conform to the shape of the z-shaped protrusion 342. do.

As described in the foregoing embodiments, the leading and subsequent ends 304a, 304b, 306a, 306b of the upper and lower members 312, 314 are preferably the largest physiologically desirable between the implant members 312, 314 when implanted. It is equipped to provide movement. Leading ends 304a and 304b may also include adjacent surfaces 352 and 354 such that the members 312 and 314 may contact and adjoin surfaces 352 and 354 when in the inserted form. The members 312, 314 may be oriented such that the surfaces 352, 354 are in flat contact when the protrusions 342 and the grooves 344 are secured or snap fit together. To this end, the upper sheath member 314 includes a flat surface 352 from which the z-shaped protrusion 342 extends so that the raised flat surface on either side of the groove 344 of the lower member 312. Adjacent to 354. The flat surface 354 is inclined upwardly from the leading or subsequent end of the lower member 312 to the tail. As illustrated, the upper member surface 352 is not inclined so that the wedge angle ω may correspond to the angle provided between the surfaces 354 and 352 by the inclination of the lower member 312 surface 354. However, the angles of the surfaces 354 and 352 are reversed so that the surface 352 is angled inward from each leading end 304, 304b, or the angles of the surfaces 354 and 352 are each angled inward, Each shape may cause surfaces 354 and 352 to be in a flat adjacent relationship at the wedge angle ω.

In order to secure the z-shaped protrusion 342 to the groove 344, the sheaths 312 and 314 may be disposed together such that the groove 344 is in a relationship facing the z-shaped protrusion 342. The z-shaped protrusion 342 includes a wing 343 angled outwardly from the base 345 of the protrusion 342 so that the leading surface 342a of the protrusion 342 is the size of the base 345. The size D3 is larger than that of D4). The groove 344 has a geometry that can accommodate the angled wing portion 343 of the protrusion 342 so that the upper side 344a of the groove 344 is smaller in size than the lower side 344b. . In this manner, hand pressure is applied to the upper and lower surfaces 320, 322 of the sheaths 312, 314 to press the wings 343 of the z-shaped protrusion 342 into the grooves 344 to snap fit. Or it can be fixed by interference fit type. Alternatively, simply align the z-shaped protrusion 342 with the opening 346 at the stern of the groove 344, and then slide the z-shaped protrusion 342 inward to move the z-shaped protrusion 342 into the groove 344. It can also stick to. At least a portion of the connection portion 340 is formed of an elastically deformable material, such that the protrusion 342, the surface to the groove 344, or both, elastically deforms to snap the protrusion 342. Or it can be accommodated in the groove | channel 344 by an interference fit type. In addition, the elastically deformable material allows the connection 340 to be released during insertion due to the suppression of implant forces and adjacent vertebrae (described in detail below). The surface of the protrusion 342 and the groove 344 may be coated with a material that facilitates the connection of the protrusion 342 and the groove forming the connection, and / or a material that resists separation of the connection 340 during implantation ( Will be described in detail below).

Thus, the interference pit provided between the connecting portions 342 and 344 is such that the axial rotation of the disc members 312 and 314 relative to each other and in particular the leading end 304a of the upper member 314 is the leading end 304a of the lower member. Provides some resistance to away from On the other hand, when sufficient force is applied to the members 312 and 314, the interference pit of the z-shaped connecting portion 340 is overcome so that the disk members 312 and 314 can move relative to each other as shown in FIG. It can represent a form. To this end, the disc device 300 selects relative to the size of the vertebral or nuclear space into which it is inserted. The distance between the subsequent or trailing end portions 306a and 306b of each member 312 and 314 in the attached insertion form is such that between the adjacent vertebrae 321, in particular the end plates 313, to which the disc device 300 should be inserted. It should be slightly larger than the distance.

Thus, if the disc device or monolith 300 slides into space as described below, the lower and upper subsequent ends 306a, 306b will be fastened to the corresponding end plates 313. Thus, in a preferred form, it is the top and bottom surfaces 322, 320 that act as fastening sites for the disc body 301 during the implantation procedure. Continued indentation of the disc monolith 300 into the vertebral disc space 311 causes the surfaces 322, 320 to be first fastened or cam moved relative to the loop, which is then gradually pressed against the vertebra and end plates 313. Gradually, you are pressed by greater force. If the disc monolith 300 is of an appropriate size for the vertebral disc space 311, the compressive force at these spaced opposing ends 306a, 306b is effectively such that the members 312, 314 have no bearing interface 315 therebetween. It will be a force large enough to grasp the releasable connection 340 to rotate relative to each other. A connection 340 is formed at the leading distal end 304 of the disc assembly 300 and the separation force is applied to the upper and lower surfaces, so that the advantage of the lever arm overcomes the interference fit of the preferred connection 340. And an intermediate dome bearing portion 319 serves as the leverage point for this purpose. This allows the bond strength between the members 312 and 314 as provided by the connection 340 to maintain the unitary insertion form of the monolith during insertion until the disc monolith 300 is inserted into the ring 309 to a sufficient degree. To make it possible. On the other hand, the wedge arrangement using the lever arms 312 and 314 as members allows the disc assembly 300 to be inserted into the vertebral disc space 311 with a relatively low force and to form an operational arrangement of the disc assembly 300. give. In addition, the small leading end shape allows the assembly 300 to be easily aligned with the incision upon initial insertion. Moreover, the separating force can be applied to the distal ends 306a and 306b when the disc monolith 300 is rotated as described above to a position fully mounted between the vertebrae in the nuclear space. In accordance with the movement between the insert and operable forms, the members 312 and 314 have an axial rotation direction as indicated by arrow P in FIGS. 35 and 36.

Inserter mechanism 400 for implanting an artificial disc device such as implant 300 is shown in FIGS. 53 and 54. The inserter 400 grips or releasably holds the sheaths 312 and 314 of the implant 300 to be inserted into the nuclear cavity 311 and rotated within the cavity.

The inserter 400 has a grip member 410 for retaining the shells 312 and 314 at the distal end 400a of the inserter 300 to hold the sheaths 312 and 314 for the first time. For example, the doctor grasps the handle 412 on the near end 400b. The first grip member in the form of a base grip 420, similar to an elongated rod, is generally secured to the handle 412 and includes a structure in the form of a protrusion 422 extending from the grip member, and the lower sheath 312 is It has a fastening structure in the form of a groove 424 formed in the surface 426. The groove 424 is formed near the trailing end 306a of the lower sheath 312. Surface 426 faces generally toward upper shell 314 when implant 300 is assembled. Thus, the protrusion 422 extends in a direction generally away from the upper sheath 314 when attached to the lower sheath 312.

The inserter 400 also includes a second grip member that can selectively reciprocate in a direction parallel to the base grip 420. Specifically, the second grip member is generally in the form of a cylindrical grip axis 432 surrounding the base grip 420, which grip axis 432 is towards the distal end 400a of the inserter 400, for example a spring 435. Tilt by). The grip shaft 432 includes a tip 434 that is contoured to contact the trailing end 306a of the lower sheath 312.

More specifically, the trailing end 306a of the lower sheath 312 includes a wall portion 436 extending from the lower sheath 312. The wall portion 436 forms a shoulder 440 at its base with the lower sheath 312 near the trailing end 306a. Shoulder 440 represents a continuous surface that includes a subsequent arcuate surface 444 in a fan shape. The intermediate arcuate surface 444b is aligned with the longitudinal size D1 of the sheath 312. The grip axis tip 434 is contoured to provide a surface 434a that conforms to the curved surface of the intermediate arcuate surface 444b. Thus, the axial tip 434 and the intermediate arcuate surface 444b occlude in a predetermined orientation.

On the side of the intermediate arcuate surface 444b is generally the form of second arcuate surfaces 444a and 444c which exhibit the same curvatures and are angled outward from the intermediate arcuate surface 444b, and also generally the same curvature, There is an arcuate side in the form of a third arcuate surface 444d, 444e angled outward from the two arcuate surfaces 444a, 444c. As an example, the total angle between the intermediate arcuate surface 444b and the left arcuate surfaces 444a and 444c or between the right arcuate surfaces 444d and 444e may be about 90 to 95 degrees. However, the arcuate sides 444a, 444c, 444d, 444e need not be oriented exactly with respect to the axial tip 434. In this manner, when the axial tip 434 opposes any arcuate side surfaces 444a, 444c, 444d, 444e, the lower sheath 312 can move in a direction opposite to the sides 444a, 444c, 444d, 444e. have. The grip shaft 432 also includes a sheath groove 446 located between the base grip 420 and the shaft tip 434 located within the grip axis 432, near the shaft tip 434.

Lower sheath 312 is secured to inserter 400 by grip axis 432 and base grip 420. To this end, the grip axis 432 is partially retracted with respect to the spring bias, causing the axis tip 434 to move away from the protrusion 422. The protrusion 422 is then inserted into the groove 424 of the lower sheath 312, and the wall portion 436 is inserted into the sheath groove 446. The group shaft 432 is then moved towards the lower sheath 312 so that the shaft tip 434 engages with the intermediate arcuate surface test spacer. In this manner, the lower sheath 312 is tightened by the biasing force of the grip axis 432, the longitudinal size of which is aligned with the elongated base grip 420 and the grip axis 432.

In a preferred embodiment, grip axis 432 may be mechanically tightened or secured such that accidental shrinkage with respect to bias does not occur. This aspect is achieved by including a biased dislocation fastening sleeve 470 with an inner cavity 472 such that the fastening sleeve 47 is positioned about the grip axis 432 and partially within the handle 412. The grip axis 432 has a wider portion 474 with an outer thread 475, forming a shoulder 477, and the fastening sleeve 470 is attached to the butt shoulder 478 and the inner hole 472 at the near end. Retains the existing shoulder 479 and thread 471 in the bore 472. There is a spring 480 between the butt shoulder 472 and the shoulder 476 formed on the handle 412, the shoulders 477, 479 are generally in contact with the force of the spring 480. Thus, the contraction of the grip axis 432 causes the shoulder 477 to press the shoulder 479 of the securing sleeve 470, thereby retracting the two shoulders together.

However, the anchoring sleeve 470 may not only contract with respect to the grip axis 432 by pressing the spring 480, but may also rotate independent of the grip axis 432. More specifically, securing sleeve thread 471 engages grip axis thread 475. When in the normal position, the spring 480 is biased from the grip shaft thread 475 toward the securing sleeve thread 471. When the securing sleeve 470 contracts with respect to the spring 480, the securing sleeve thread 471 moves to a position where it can be engaged with the grip shaft thread 475. The securing sleeve 470 can be rotated by the nodal knob 490, whereby the securing sleeve fits over the grip axis 432. As a result, the knob 490 comes into contact with the handle 412 to tighten the securing sleeve 470 with the grip shaft 432 sandwiched in the securing sleeve 470. In this manner, grip axis 432 is not retractable and lower sheath 312 is secured and locked between grip axis 432 and fixed base grip 420.

Inserter 400 may also secure upper sheath 314 for insertion. To this end, the inserter 400 includes a third grip in the form of a yoke grip 450, and the upper sheath 314 has a grip post 460 that is received in the yoke grip 450. Yoke grip 450 generally includes an elongate axis 454 located within grip axis 432 and a pair of yoke arms 452 at the distal end 450A. Each yoke arm 452 includes a cup-shaped or hemispherical groove 456 on its medial side, with the cup-shaped grooves 456 of each yoke arm 452 generally facing each other,

The grip pillar 460 of the upper sheath 314 includes an outer surface 462 for fastening into the cup groove 456. To insert the grip post 460 into the yoke arm 452, the yoke arm 452 can be bent slightly outward, as well as the grip post 460 can be slightly pressed. In this manner, grip post 460 snaps or is forced fit into yoke arm 452 and is releasably secured. Unlike the fixation of the lower sheath 312 in a fixed orientation with the inserter 400 in its initial position, the upper sheath 314 pivots around the grip post 460 within the yoke arm 452 like a ball joint. Can rotate

Note that the sheaths 312 and 314 can be secured to form a z-shaped joint 340 before being secured to the inserter 400. Alternatively, the sheaths 312 and 314 may be provided by an insertion orientation after being secured to the inserter 400. To this end, since the upper sheath 314 can be axially rotated, it is only necessary to apply pressure by hand to press the z-shaped protrusion 342 and the groove 344 together. As another alternative, the inserter 400 may be secured to the upper shell 314 such that the upper surface 322 is provided at a particular angle and the shells 312 and 314 are then provided in a wedge angle ω and an insertion form. have.

Once releasably secured to the inserter 400 in an insert form, the implant 300 is ready to be inserted into the ring 309 and nuclear cavity 311. As noted above, the insertion force by the implant 300 moves the implant 300 from an insert form into an operative form. Also, as noted above, inserter 400 may be used to rotate implant 300 such that large longitudinal size D1 is aligned towards incision 308 within ring 309. The implant 300 may contact the inner side 309a of the ring during insertion and rotation, which contact guides the implant 300 into the nuclear cavity 311 and causes rotation of the implant 300 therein. Induce. Such implant 300 and inserter 400 may be used in a variety of surgical attempts or techniques, such as surgery in a direction other than back surgery. For example, when in the lateral incision direction, the manipulation and collaboration of the inserter 400 and the implant 300 does not require the same adjustments that were needed in the rear end attempt.

Once the implant 300 is moved into operative form, the upper sheath 314 is generally not free to move. That is, despite being fixed to the inserter 400 by the ball joint corrosion of the grip pillar 460 and the yoke arm 452, the upper shell 314 is the ring 309 and the vertebral end plate 313 Of course, it is pressed by the significant movement of the articulated bearing member 30 formed between the outer shell (312, 314). Thus, upper sheath 314 generally follows lower sheath 312.

The lower sheath 312 is generally secured to the inserter 400 until the physician selects another means. When it is measured that the implant 300 has advanced sufficiently into the ring 309 and nuclear cavity 311 such that stiffness is no longer needed, or it is measured that the implant is in a position to be rotated, the grip axis ( 432 may cause lower sheath 312 to move or axially rotate around protrusion 422 with respect to one of arcuate sides 444a, 444c, 444d, and 444e. The bias of the grip axis 432 can then move the grip axis 4321 in an adjacent relationship with one of the sides 444a, 444c, 444d, 444e. Accordingly, the upper sheath 314 also axially rotates with the lower sheath 312 around the grip post 460. If the arcuate sides 444a, 444c, 444d, and 444e are angled with the intermediate arcuate surface 444b, the surgeon may implant when the axial tip 434 is secured to one of the arcuate sides 444a, 444c, 444d, and 444e. 300 can be guided into the nuclear cavity 311 in the lateral direction (orthogonal to the fore and aft direction).

It should also be noted that as soon as the implant 300 is fully inserted into the incision, the grip axis 432 can be fully retracted. The lower and upper sheaths 312 and 314 can rotate but generally disengage because the upper and lower end plates 313, along with the yoke arm 452 and the grip shaft protrusion 422, exert pressure and pressure. There is no. In this manner, the surgeon may axially implant the implant 300 within the nuclear cavity 311 until the desired position is reached while the grip axis 432 is biased by a spring facing the surface 444. Can be rotated and manipulated.

In order to remove the inserter 400, the implant 300 must first be released. According to a preferred embodiment, the yoke grip 450 may be selectively reciprocated by a slide 490. In order to secure the upper sheath 314 to it, the yoke grip 450 is advanced relative to the grip axis 432 by advancing the faceplate 490 relative to the handle 412. The letter board 490 includes a pillar 492 that is received in the groove 494 of the yoke grip axis 454 in the handle 412. To release the implant 300, the shroud 490 is contracted, thereby shrinking the yoke grip 450 to release the upper sheath 314. If the skin members 312 and 314 are occluded, this contraction will cause the yoke arm 452 to separate from the upper skin 314. Alternatively, this contraction can pull the yoke arm 452 into the cylindrical grip axis 432 such that the trailing end 306b of the upper sheath 314 contacts the edge 498 of the grip axis 432. do. Continuous contraction of the yoke grip 450 causes the upper sheath 314 to release from the yoke arm 452. As another alternative, the contraction of the yoke grip 450 causes the upper sheath 314 to be pushed away from the yoke arm 452 by pressing the upper sheath 314 against a portion of the base grip 420, such as the pillar 500. You can make it die. The grip axis 432 can then be retracted and the protrusion 422 can be peeled off from the groove 424.

The proximal end 400b of the handle 412 includes an opening 510 to which the release 512 is fixed and spring biased in an adjacent direction. When the bias is released and the release 512 is pushed into the handle 412, the pin 514 moves from the stuck position to the release position. In the secured position, pin 514 is received in groove 516 and secures base grip 420 to a generally fixed position. In the release position, the pin 514 can be removed from the groove 516 to remove the base grip 420 along with the yoke grip 450 and the typography 490. In this way, the inserter 400 can be dismantled for cleaning and sterilization post-treatment.

Referring now to FIG. 55, another aspect of implant 600 has an upper sheath 614 and a lower sheath 612 forming articulated bearing member 30. Upper envelope 614 has grooves 616 that receive and articulate domes 618 over spacers 620. The spacer 620 may be fixed to the stepped groove 630 to move slightly in the stepped groove 630. More specifically, spacer 620 has a suspended column 622 having a lower flange 624 that secures to the groove bottom 632 of the stepped groove 630. The spacer 620 has an intermediate pillar portion 626 that connects the lower flange 624 to the dome 618. The intermediate pillar portion 626 is located in the intermediate groove portion 634 of the stepped groove 630 and is slightly smaller than that. The dome 618 includes a lower surface 640 that forms the intermediate pillar portion 626 and the shoulder 642. The stepped groove 630 includes an upper groove portion 636 in which a low friction washer or bushing 638 is present to reduce friction. That is, the bushing 638 has an upper surface 638a adjacent to the lower surface 640 of the dome 618, and a lower surface adjacent to the upper surface 636a of the lower sheath 612 at the upper groove portion 636. Retain (638b). Bushing 638 may be a polymer, such as polyurethane.

Referring again to FIG. 35, another heterozygous connection is virtually represented as a band 333 connected to the upper member 314 and the lower member 312 at the insertion end of the implant 300. Band 333 holds insertion shaped members 312 and 314 that provide a wedge angle ω as described above during initial insertion. As the force acting on the members 312 and 314 by inserting against spinal material such as rings or vertebrae increases, the band 333 breaks or breaks off one of the members 312 and 314, causing the members 312 and 314 to break. The tension on the band 333 increases until it is switched to operable form. Furthermore, the band 333 may be a bioabsorbable material in which the band 333 is absorbed after a certain time.

Continuing with reference to FIGS. 35 and 41 and 46, another heterozygous linkage is indicated by chemical bond 339. The chemical bond 339 may be located at the flat surface 352 of the upper skin member 314, the flat surface 354 of either groove 344 of the lower member 312, or both. As noted above, the heterozygous connection of the chemical bond 339 holds the members 312 and 314 in position during initial insertion until the bond 339 is broken to convert the members 312 and 314 into operative form. Let's do it. In addition, the chemical bond 339 may be bioabsorbable or biocompatible.

FIG. 56 illustrates a further embodiment of the implant 650 in the insert form having an upper sheath 662 and a lower sheath 660 forming articulated bearing member 30. Like the implant 300, the implant 650 has an axial rotation direction P. As shown in FIG. The collaboration structure allows the implant to have an insert form. The cooperative structure includes a hook 670 over the leading end 672 of the upper sheath 662 and a prong 674 at the leading end 676 of the lower sheath 660. In this aspect, the force exerted on the sheaths 660 and 662 during insertion causes the hook 670 to disengage from the prong 674 and the sheaths 660 and 662 are pivoted in the axial rotation direction P and operable. Allows you to reorient to a location.

57-60, the implant 700 has an upper sheath 724 and a lower sheath 712 that form a butt joint in an interference fit manner. Lower sheath 712 has a leading end 712a and has a groove 720 located proximate this leading end 712a. The groove 720 is angled downward to deepen toward the leading end 712a and forms an angled surface 722 therein. A lip 728 is formed near the outer circumference 724 of the groove 720 and the upper surface 726 of the lower sheath 712. The upper sheath 714 includes a surface 740 that gradually increases upward toward the leading end 714a. Tongue 742 extends from this surface 740 and retains lip 744 around the perimeter 746 of tongue 742. Tongue 742 of upper sheath 714 is received in groove 720 such that lip 744 of upper sheath 714 faces lip 728 of lower sheath 712. Faced ribs 744, 728 form an interference pit to keep implant 700 in the shape of an insertion. When sufficient insertion force is applied to the implant 700, the ribs 744, 728 are released from each other and the skin is axially rotated in the axial rotation direction P, and can be reoriented in an operative form.

According to aspects of the present invention, there are a variety of implants that can be provided and selected for the surgical procedure. Such implants may vary in size depending on the size of the nuclear cavity. In addition, the vertebral end plates to which the implant should be placed may not be generally parallel to each other. Thus, the implant 300 may have a similar form of operative form in preparation for the natural curvature of the contiguous vertebra as soon as it is implanted and rotated. As such, the operative form provides implant top and bottom surfaces 322a and 320a that achieve an operative angle θ corresponding to the end plate angle of the adjacent vertebral body. As can be seen in FIGS. 69 to 71, the operability angle θ is the angle measured between the upper and lower surfaces 322a, 320a of the operable form measured in the front-rear direction.

The implant members 312, 314 of the implant monolith 300 shown in FIGS. 69 and 70 have respective major planes 300a, 300b as described above in the longitudinal and transverse axes of the implant members 312, 314. do. As indicated, planes 300a and 300b are generally parallel when in actuated form. The operability angle θ is defined by the upper and lower surfaces 322a and 320a when the planes 300a and 300b are generally parallel. Thus, the artificial disc monolith 300 may be provided in several different sizes depending on the size of the implant members 312 and 314 including the operability angle θ. For example, the implant 300 may have an operability angle θ of 0 °, 6 ° or 12 °.

In order to select the appropriate size and operability angle θ, the implant site is examined. For this purpose, a test spacer 800 as shown in FIGS. 61 and 62 may be used. The test spacer 800 is used as a series of test spacers, and representative test spacers 850 are shown in FIGS. 63 and 64. As shown, the test spacer 850 preferably has an operability angle θ of 0 °, 6 ° or 12 ° in order to be able to mate with a suitable implant 300, but with an operability angle of 0 °. Is fulfilling.

The test spacer 800 includes an elongate handle 810 with a brace 812 on one side. The brace 812 includes two arms 814, each arm including a longitudinally aligned hole 816 of the handle 810. Between the arms 814 is a nut 818 separated from the arm 814 by a low friction washer (not shown). This nut 818 includes a central internal threaded hole 820 that is aligned with the hole 816 of the arm 814. Screws 824 are located within the holes 816, 820, which include threads that engage the threads of the nut hole 820. The nut 818 is located between the two arms 814, and is generally fixed, between which rotation is free. As the nut 818 rotates relatively, the screw 824 present in the nut hole 820 axially rotates about the arm 814 and the handle 810.

To this end, the screw 824 has a far end that is non-rotatively connected to the letterhead arm 828. Accordingly, the nut 818 may rotate clockwise relative to the screw 824 to advance the screw 824 and to reverse the screw 824. The typeface arm 828 is also connected to the screw 824 and thus advances or retracts along the screw 824. The letter arm 828 is aligned with and adjacent to the rail arm 830 secured to the handle 810. In this manner, the screw 824 can be advanced or retracted to advance or retract the rail arm 830 relative to the rail arm 830 in the same direction.

The test spacer 850 is fixed to the far end 800a of the test spacer 800. More specifically, the test spacer 850 includes a test spacer body 852, an instrument port 854, and a securing pin 856. Instrument port 854 is a groove in which top and bottom walls 860 and back walls 862 are located laterally. Pin 856 moves through each upper and lower wall 860 and instrument port 854 groove. Instrument port 854 receives the far end 800a of test spacer instrument 800, to which test spacer 850 is generally secured.

The slide arm 828 and the rail arm 830 each hold respective far ends 828a and 830a. Rail arm distal end 830a includes a barb or hook 840. When the style arm 828 retracts by a sufficient distance, the hook 840 is exposed so that the pin 856 can be located therein. The letter arm 828 then advances toward its distal end 828a and passes over the hook 840. In this way, the pin 856 located therein is captured and generally prevents the hook 840 from running away. Moreover, the typology arm 828 may be advanced such that the terminal surface 828b of the distal end 828a is adjacent to the inner wall 861 in the instrument port 854. In this position, the occlusal surface 828b and the inner wall 861 generally do not move with each other, causing the test spacer 850 to be generally locked in a particular orientation with respect to the test spacer instrument 800. When this typeface arm 828 is retracted by a predetermined amount from the locked position, the test spacer 850 can be rotated whenever insertion into the nuclear space is required. As the style arm 828 retracts further, the pin 856 can be released from the hook 840 and the test spacer instrument 800 can be removed.

The test spacer 850 is generally shaped to be easily inserted through the incision to measure nuclear cavity size. Such test spacer 850 may have a leading end 870 tapered for flat or easy insertion. Test spacer 850 may also be formed such that the required operability angle θ can be measured. The edges of the test spacer 850 may be radial or smooth to facilitate insertion and manipulation. Multiple test spacers 850 of various dimensional sizes are continuously attached to the distal end 800a of the test spacer instrument 800 and inserted into the incision to provide an appropriate size operability angle θ of the implant to be used for surgery. It can be measured. Alternatively, the leading end 870 may not be tapered.

The handle 810 of the test spacer device 800 may include a structure that allows additional instruments to be used for insertion of the test spacer device 800. More specifically, as shown in FIGS. 65 and 66, alternative test spacer instrument 900 provides direct controlled collisions through the central longitudinal axis of instrument 900 that is connected to test spacer 850. Guide or tapping mechanism 910 for the purpose. In this aspect, the tapping mechanism is near-terminal 900a of the instrument 900, which is slid and received by a mass support in the form of a cylindrical slab 922 to which the handle 920 is connected to the first end 922a. It is in the form of a mass (910). Thus, the mass 910 may be in a position remote from the handle 920 and then guided toward the handle 920 along the letter board 922 to impinge on the handle 920. Momentum of the mass 910 is transferred to the handle 920 to guide the test spacer 850 into the nuclear space through the ring. The mass 910 may be accelerated towards the handle 920 by a surgeon or by mass weight. A stub 915 is present at the second end 922b of the tympanic 922, indicating how far the mass 910 can be positioned away from the handle 920 and retaining the mass 910 in the instrument 900. You can. That is, the operation of the tapping mechanism 910 allows a more regulated force to be transmitted to the test spacer 850 than the manual force and prevents the surgeon from pushing the test spacer 850 too hard or too far. It works.

The test spacer mechanism 900 also includes a replacement advance mechanism. The test spacer mechanism 900 has a typographic arm 928 and a rail arm 930 similar to those described above for the test spacer mechanism 800. The slide arm 928 and rail arm 930 are secured to each other by sliding projections 932 extending from the slide arm 928 and received in the slots 934 of the rail arm 930. The protrusion 932 is allowed to reciprocate within the slot 934 and also guide the letter arm 928 and rail arm 930 in a linear translational motion. The tag arm 928 also includes a bracket 940 that extends from the side 942 of the tag arm 928, which generally includes the rail guide 949 in which the bracket arm 944 is formed on the rail arm 930. It forms around the bottom 948 and side 946 to form a C shape. In addition, the capture bracket 950 is located at a further distant portion of the tag arm 928, which capture bracket 950 extends from the side 952 of the tag arm 928, with the capture arm 954 being a rail arm. Form C generally surrounding the sides 930a and bottom 930b of 930. In addition, the bracket 940 serves to attach the rail arm 930 and the plate arm 928 to slide as if sliding. The slide arm 928 and the rail arm 930 are the slide arm to a position where the test spacer 850 is received and extended by the hook 840 as described above to capture the test spacer 950 therein. 928 translates linearly with respect to each other to retreat.

In the illustrated embodiment, the test spacer 900 is provided at a selectable separate location. More specifically, the slide arm 928 may slide relative to the rail arm 930 to and between a predetermined discrete position. Rail arm 930 includes a port 960 that is generally open relative to plate arm 928. Port 960 includes a spring biased member, which is pillar 962 as in the illustrated embodiment, but may be a ball or other structure. The pillar 962 is pressed obliquely against the surface 964 on the rail arm 930, and the surface 964 includes a groove 966 like a detent. Thus, when the rail arm 930 and the leaf arm 928 are relatively positioned such that the pillar 962 is press-fitted into the groove 966, the bias for supporting the pillar 962 in the groove 966 is the slide arm 928. It must be overwhelmed to move relative to this rail arm 930.

More specifically, the groove 966 includes a first groove 966a, and the letter arm 928 may retract to the position of the column 962 in the first groove 966a, such a letter arm 928. Is removed from the hook 840. In addition, when the bracket arm 944 is aligned with the space 970 at the proximal end 949a of the rail guide 949 in the retracted position, the letter arm 928 is removed from the rail arm 930 for cleaning or the like. Can be.

The second groove 966b may be provided where the pillar 962 may be located when the plate arm 928 extends shortly with respect to the rail arm 930. In this position, the leaf arm 928 and rail arm 930 are generally secured to each other, and the leaf arm 928 is hooked so that the test spacer 950 can be attached or removed from the test spacer device 900. It is removed at 840.

The third groove 966c is provided when the stem arm 928 extends so that the pillar 962 moves from the second groove 966c to the third groove 966c. In this position, the test spacer 840 attached to the test spacer instrument 900 is allowed to rotate in the range of 0 to 45 degrees.

Finally, the fourth groove 966d may be provided. The letter arm 928 may be fully extended such that the test spacer 940 is secured therein and generally submerged in a particular orientation. In this case, pillar 962 is located in groove 966d.

Representative surgical techniques are described in FIGS. 67 and 68. In particular, this technique involves cutting the tissue around the damaged intervertebral disc to expose the rings. Pre-measure the size of the artificial disc device to be implanted or select the minimum incision size. Then the incision is made through the interior of the disc to a depth sufficient to reach the nucleus. Next, at least a portion of the nuclear material is removed to form a cavity in the ring for receiving the artificial disc device. The test spacer is then selected, secured to the test spacer, and then guided to the incision. Investigate the suitability of the test spacer (if the cavity permits the introduction of the test spacer) to assess whether the test spacer accurately measures the cavity size and shape, including the operability angle θ. If the test spacer is not suitable based on the available test spacers and corresponding implants, another test spacer is selected and inserted into the cavity until a suitable test spacer is determined. Once the appropriate test spacer is determined, the implant is selected based on the test spacer. That is, an artificial disc device is selected for size and operability angle θ based on the test spacer determined to be appropriate.

The artificial disc device is then formed into an insert form and attached to the inserter mechanism. The artificial disc device may be formed first and then attached to the inserter device and vice versa.

To form the implant in the insert form, the collaborative structure of the implant is joined so that the leading end of the implant is relatively small and the implant forms a wedge angle. For example, a first member with a winged z-shaped protrusion can be positioned close to a second member with a groove of a structure that engages the structure of this z-shaped protrusion. Manual pressure is applied to these members to press the z-shaped protrusion into the groove. Alternatively, the z-shaped protrusion is slid to the open end of the groove to join the groove and the z-shaped protrusion. As noted above, other connection or collaboration structures may be used to connect the implant member.

The inserter mechanism can be coupled to the first and second members of the implant. The inserter mechanism may include a protrusion over the first grip member, the protrusion being axially received in a groove formed in the first implant member. Retracting the aforementioned second grip member in the form of a grip axis to insert the protrusion into the groove inserts the protrusion into the groove. The grip axis is then released and, when holding the dislocation spring bias, the grip axis moves forward and comes into contact with the first implant member. The first implant member is then aligned with the grip axis such that the arcuate surface on the first implant member accepts the arcuate shaft tip in an occlusal relationship. The fixation sleeve is then moved backwards and rotated so that the grip axis is engaged with the arcuate surface of the first implant member. The yoke grip of the inserter mechanism is then extended. The yoke grip receives and secures the column present in the second implant member. These pillars and / or opposing yoke arms bend to allow the pillars to be trapped in the yoke grips.

Once the first and second implant members are secured to the inserter instrument, the implant is ready for implantation. Make sure that the incision size in the ring is large enough for the selected implant. If not, enlarge the incision. The small leading end of the implant is then aligned with the incision of the ring. The force is then applied to guide the implant into the incision and into the nuclear cavity.

When the implant is inserted, the outer surfaces of the first and second members come into contact with the ring and the vertebral end plates. As the force increases, this contact causes the cooperative structure to release, providing a connection between the first and second implant members. In this manner, the implant member is converted from an insert form into an operable form, and these implant members are free to rotate and rotate relative to one another in the nuclear cavity.

After or at the time of switching to the operable form, the implant rotates. More specifically, the anchoring sleeve may disengage and the grip axis may retract. The axial tip is then cam cambed as an arcuate surface and initially aligned with the side arcuate surface disposed adjacent to the arcuate surface. In this manner, the implant is movably secured to the inserter instrument such that the implant can be rotated and aligned in the proper orientation. In addition, the inserter mechanism can continuously insert and manipulate the implant. The implant is then adjusted to the desired position or orientation in the nuclear cavity. As noted above, a radiopaque marker is used on the implant member to facilitate implant location surveys of physicians using radiographic equipment.

If the implant is in the desired position and orientation, the inserter mechanism can be removed. More specifically, the yoke grips are retracted to allow the column to escape from the yoke arm. This is for example done in contact with a structure which is relatively stationary on the base grip. The grip axis is then retracted so that the tip of the axis retracts from the first implant member and there is no first implant member in the grip axis itself. The protrusion on the base grip is then removed from the groove of the first implant member. At this point, the inserter instrument may be removed from the ring and generally the surgical site.

The natural disc is the lumbar region that is currently reported to have a typical range of motion. The average range of motion at bending / extension is 12 to 17 °, the average range of lateral bend is 6 to 16 ° and the average range of axial rotation is 2 to 3 °. According to the present invention, the bending / extension range is in the range of 15 to 20 °, the side bend is in the range of 7.5 to 8 °, and there is no limit to the axis rotation.

While the invention has been described above with respect to specific examples, including presently preferred embodiments of the invention, those skilled in the art will recognize that various modifications of the foregoing systems and techniques belong to the spirit and scope of the invention as set forth in the claims that follow. You know that there may be a replacement.

Claims (49)

An implantable spinal nucleus device for implanting an intervertebral disc nucleus that is implanted between adjacent axially spaced upper and lower vertebral bodies, A rigid upper sheath contacting the upper vertebral body and sized appropriately within the annulus of the intervertebral disc; A rigid lower sheath contacting the lower vertebral body and sized appropriately within the annulus of the intervertebral disc; And At least one bearing member present between the upper and lower sheaths and allowing relative movement between the upper and lower sheaths Device that can be held in the ring, including. The device of claim 1, wherein the at least one bearing member is a multi-axis articulated bearing member that exists between the at least one upper and lower sheaths. The device of claim 1, wherein the shell and bearing member can be inserted sequentially through the cutout of the ring, and the device can be assembled in the ring. The apparatus of claim 1, further comprising a spacer member forming an articulated bearing member, wherein the device is in a compressed arrangement while being inserted into the ring and can be expanded in an expanded arrangement after being implanted in the ring. Device. The method of claim 1, wherein the upper sheath has a generally flexible upper surface for non-invasive contact with the upper vertebrae in the annulus of the intervertebral disc, and the lower sheath is generally flexible for non-invasive contact with the lower vertebrae in the annulus of the intervertebral disc. Apparatus characterized by having a bottom surface. The incision of claim 1, wherein each sheath has a transversely sized end and a longitudinally sized end that is greater than the transverse size and each sheath is through the incision of the ring so that the transverse sized end precedes the incision. Device characterized in that it can be inserted. 7. The ring of claim 6 wherein the ring has a transverse size and a longitudinal size, wherein the transverse size of the ring is greater than the longitudinal size of the ring, and each sheath is such that the transverse size of the shell is aligned with the transverse size of the ring. Device characterized in that it can be arranged. 8. The device of claim 7, wherein each shell is rotated as it is inserted through the incision such that the inserted shell is arranged such that the transverse size of the envelope is aligned with the transverse size of the ring. 8. The device of claim 7, wherein each sheath is inserted through the incision and then rotated such that the inserted sheath is arranged such that the transverse size of the sheath is aligned with the transverse size of the ring. An implantable spinal nucleus device for implanting an intervertebral disc nucleus that is implanted between adjacent axially spaced upper and lower vertebral bodies, An upper sheath contacting the upper vertebral body and sized appropriately within the annulus of the intervertebral disc; A lower sheath contacting the lower vertebral body and sized appropriately within the annulus of the intervertebral disc; And At least one bearing member present between the upper and lower sheaths and allowing sliding and multiaxial movement of the upper and lower sheaths between the upper and lower sheaths. The bearing member of claim 10, wherein the bearing member Steel surface with radius of curvature; And A concave surface receiving the convex surface and having a radius of curvature And wherein the relative radius of curvature can be selected to form a stiffness for multiaxial movement between the upper and lower sheaths. An implantable spinal nucleus device for implanting an intervertebral disc nucleus that is implanted between adjacent axially spaced upper and lower vertebral bodies, An upper sheath having a convex upper surface in contact with the upper vertebra and selected according to the concave surface of the upper vertebral surface and sized appropriately within the annulus of the intervertebral disc; A lower sheath having a convex lower surface in contact with the lower vertebrae and selected according to the concave surface of the lower vertebrae and sized appropriately within the annulus of the intervertebral disc; And At least one bearing member present between the upper and lower sheaths and allowing relative movement between the upper and lower sheaths. 13. The device of claim 12, wherein at least one of the convex surfaces has a radius of curvature that is greater than the radius of curvature of the vertebral body in contact with the surface. 13. The device of claim 12, wherein at least one of the convex surfaces has a radius of curvature that is less than the radius of curvature of the vertebral body in contact with the surface. 13. The device of claim 12, wherein at least one of the convex surfaces has a radius of curvature equal to the radius of curvature of the vertebral body in contact with the surface. Preparing an implantable device comprising a plurality of components; Measuring the minimum incision size through which each component passes; Providing an incision in the annulus of the intervertebral disc such that the incision forms a deformable opening sized according to the minimum incision size through which each component can pass; Orienting the insertion component through this incision; Sequentially inserting the components through the incision; And Assembling the components to form a device in the ring. The method of claim 16, further comprising rotating at least one of the components after the leading end of the components has been inserted into the ring. Preparing an implant device having a rigid upper member, a rigid lower member and a spacer member; Assembling the apparatus into a folded arrangement having a predetermined size in a predetermined direction; Providing an incision in the annulus of the intervertebral disc to form a deformable incision that is sized according to a predetermined size so that the device in this folded arrangement can pass through the incision; Inserting the folded arrangement of devices through this incision; And Expanding the device to the nucleus of the intervertebral disc, including expanding the device in an expanded array of devices having a size greater than the predetermined size in at least a predetermined direction. 19. The method of claim 18, wherein expanding the device comprises moving a portion of the spacer member relative to at least one of the upper member and the lower member. 19. The method of claim 18, wherein inflating the device comprises injecting a flowable material into the spacer member to expand the spacer member between the upper and lower members. The device of claim 1, wherein the upper and lower sheaths comprise a cooperative structure for simultaneously implanting the sheaths between the vertebrae. An artificial disc device for inserting between the upper and lower vertebrae, Disc body; A first body portion and a second body portion connected in an insertion form that allows insertion with less force between the vertebrae and an operative form that allows relative movement between the body portions when the vertebrae is moved; 2 Artificial disc device, characterized in that the body portion is switched from the insert form to the operable form when inserted between the vertebrae. 23. An artificial disc device according to claim 22, characterized in that it comprises a fastening portion in an insertion form that is sized to abut against the upper and lower vertebrae so that when the body portion is inserted between the vertebrae, the body portion is switched from the insert form to the operative form. . 23. An artificial disc device according to claim 22, comprising a main body portion and a second body portion between the body portion converted from the insert form into the operative form and a releasable connecting portion for release. 23. An artificial disc apparatus according to claim 22, comprising a snap pit connection therebetween such that the first body portion and the second body portion snap together when in the inserted form. 23. The artificial disc device according to claim 22, wherein the insertion form comprises a wedge shape. 23. An artificial disc apparatus according to claim 22, wherein the body portions are in a substantially fixed orientation with respect to each other when the body portions are in the inserted form. 23. The apparatus of claim 22, wherein each body portion comprises a first end and a second end; The corresponding first end of the body part is connected, wherein the corresponding second end of each body is connected farther apart from each other than the connected first end when the body part is in the inserted form. 29. The second end of claim 28 wherein one of the first body portion and the second body portion comprises a bearing portion and the other body portion is generally away from the first body portion and along the bearing portion from its connected first end. An artificial disc device, characterized by extending toward. A method of implanting an artificial disc device between an upper and lower cone, Connecting the disc device in an inserted form; Inserting the disc device between the vertebral bodies; Engaging the vertebral body with a portion of the disc device during insertion; Continually inserting the disc device to release the connecting portion; And Releasing the connection to convert the disc device to an operative form. 31. The method of claim 30, further comprising orienting the upper and lower members of the disk apparatus in an inserted form with an upper and lower outer surface at an angle, wherein connecting the disk apparatus comprises the upper member and the lower member. And linking the members into a collaborative structure. 32. The method of claim 31, wherein joining the upper member and the lower member comprises forming an interference fit between the upper member and the lower member. 33. The method of claim 32, wherein the interference pit is a snap-fit. 34. The method of claim 33, further comprising cam-moving the upper and lower sides opposite the upper and lower vertebrae to separate the cooperative structure. As a way to replace the nucleus of the intervertebral discs, Providing an implant device having a major and minor size; Forming an incision of a predetermined size in the intervertebral disc ring; Orienting the device such that the minor size is aligned with the incision to maintain a predetermined incision size; Inserting the device into the nuclear space through the incision; And Rotating the device such that at least a portion of the major size is aligned with the incision. 36. The method of claim 35, wherein forming the incision comprises cutting a portion of the ring at an angle inclined to the front-back direction of the intervertebral disc. 36. The method of claim 35, further comprising selectively attaching the inserter mechanism to the device. 38. The method of claim 37, further comprising fixedly securing the device in a predetermined orientation with respect to the inserter mechanism prior to inserting the device. 39. The method of claim 38, wherein the inserter mechanism comprises a grip member, and wherein securing the device securely comprises securing the device and the grip member. 40. The method of claim 39, further comprising adjusting the grip member after the inserting step to axially rotate the inserter mechanism and the discus device relative to each other. 36. The method of claim 35, wherein forming the incision comprises fitting the incision based on at least the minor size of the device. 36. The method of claim 35, further comprising selecting the device based on one of the size of the intervertebral disc, the angle formed between the upper and lower vertebral bodies, and the size of the nuclear cavity. 43. The method of claim 42, further comprising inserting a test spacer into the nuclear space to select an artificial disc device. 44. The method of claim 43, wherein inserting the test spacer comprises using the test spacer mechanism to guide the test spacer in the ring. 36. The method of claim 35, wherein rotating the device occurs during the step of inserting the device. 36. The method of claim 35, wherein rotating the device comprises contacting the inner wall of the ring to allow the device to slide and position therein. As a system for replacing the nucleus of the intervertebral discs, Nuclear devices for insertion; And And an insertion instrument, said nuclear device being rotatably attachable to said insertion instrument, said device being able to rotate to at least two different positions. As a system for replacing the nucleus of the intervertebral discs, Nuclear devices for insertion with a minor size end; And And an insertion instrument, wherein the device is attachable to the insertion instrument at the minor size end. An implantable spinal nuclear device that replaces the nucleus of the intervertebral disc, Upper sheath; And And a lower shell, implanted between adjacent upper and lower vertebrae, wherein at least one of the shells has an outer surface at an angle with at least one of the vertebral bodies.

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