KR20070022042A - Screw assembly - Google Patents

Abstract

Medical devices for supporting a structure (such as bone) and methods of use thereof are provided. Screw assemblies 1, 101, 1101 are provided which may include bases 3, 102, 1102, one or more arms, and interconnecting means 4, 105 that couple the base to one or more arms. The interconnecting means allow the arm to be positioned in a first position parallel to the long axis of the base and in a second position perpendicular to the long axis of the base. The base may be formed to attach to the structure, and one or more arms may be formed to attach to one or more support structures. A support structure 10 with an opening 11 and fixing means 9, 1107 may be provided, which support structure is formed as an open end saddle that is attached to a medical device (eg a screw assembly) after being installed in a patient. Can be.

Arm, vertebrae, additional, screw assembly, arm

Description

Screw Assembly {SCREW ASSEMBLY}

The present invention relates to a medical device.

It is well established to use spinal stabilization / fixation devices to align or locate specific vertebral or spinal regions. In general, such devices use spinal fixation members that consist of relatively rigid members, such as plates, boards or rods, and are used as couplers between adjacent vertebrae. Such spinal fixation devices can accurately position adjacent vertebrae when attached (eg, when attached to the vertebrae of the vertebrae) using bone fixation screws (eg, pedicle screws). When the vertebrae that are joined to each other are fixed in place, several surgical procedures may be performed, treatment may proceed, or spinal coupling may be performed.

Spinal fixation members may be inserted into the posterior region to stabilize the various vertebrae of the spine, for example with percutaneous kyphoplasty, which forms voids or cavities in the vertebrae that are then filled with bone substitutes to form "internal castings." Can be. Some conventional devices are designed to attach directly to the back of the spine for this purpose, but the invasive nature of the conventional posterior approach utilized to implant these devices introduces several drawbacks. One solution that has minimally invasive characteristics as a solution to the problem of this posterior approach is that instead of removing the lateral lateral muscles from the posterior spine, they utilize the natural segmentation between the multifidus and the longest muscles. The longitudinal divisions of the sacral vertebrae are formed between the muscles. The problem with these conventional solutions is that the high degree of invasiveness results in muscle rupture and blood loss. This loss of spinal lateral muscle attachment points, the formation of scar tissue, and loss of muscle function can worsen the patient's final condition. Further, according to the prior art solution, it is not only time-consuming but also difficult to remove.

In general, in one aspect, the present invention provides a medical device for supporting a structure comprising a screw assembly. The screw assembly includes a base, an arm, and interconnecting means for coupling the base to the arm. The interconnecting means allow the arm to be positioned in a first position parallel to the long axis of the base and in a second position perpendicular to the long axis of the base. The base is formed to attach to the structure of the patient and the arm is formed to attach to the support structure. In one embodiment, the structure to be attached is a bone.

The medical device of the present invention may comprise a support structure, and the screw assembly may be attached to the support structure by an arm. Alternatively, two screw assemblies can be attached to the support structure.

The screw assembly is formed of a material selected from the group consisting of titanium, stainless steel, carbon fiber, shape memory metals, biocompatible materials and reabsorbable materials, and composites or combinations of these materials. Can be. Alternatively, the screw assembly may be formed from a continuous member of shape memory metal. In one embodiment, the interconnecting means is formed of a shape memory metal. In yet another embodiment, the screw assembly and the interconnecting means are formed of a metal member suitable for bending.

The length of the screw assembly can vary and the total length is from 0.1 cm to 100 cm. In one embodiment, this overall length is from 50 mm to 600 mm. In yet another embodiment, the entire length of the screw assembly is formed to support the spine subcutaneously. In yet another embodiment, the entire length of the screw assembly is formed to subcutaneously support the back of the spine.

The arm of the screw assembly may consist of a body, a base yoke and a connector end. The body of the arm can be any shape, including a rod shape.

The base of the screw assembly may consist of a base head and an anchor. The anchor may be selected from the group consisting of screws, staples, hooks or nails. In one embodiment, the anchor is a screw formed to be secured to the bone. In another embodiment, the anchor is a screw that is configured to be inserted into the pubic vertebrae.

The interconnecting means of the screw assembly can have any configuration. In one embodiment, the interconnecting means comprises a press-fit cross pin. In another embodiment, the interconnecting means consists of an open saddle head and a mating cross piece. The interconnecting means may also comprise a set screw, which sets the arm and the base together as a single unit. The set screw can also be fastened in the interconnecting means to fix the arm in a position perpendicular to the long axis of the base. In yet another embodiment, the securing means may comprise a cam which performs a function similar to a set screw.

In one embodiment, the medical device of the present invention may consist of one screw assembly and a support structure, wherein the support structure comprises a top surface, a bottom surface, an opening and two receiving portions. According to this embodiment, the opening extends from the top surface of the support structure to the bottom surface and an anchor is disposed in the central opening perpendicular to the top surface of the support structure.

The support structure may consist of a top surface, a bottom surface and two receiving portions. Each receptacle may include an open end saddle shaped receptacle configured to attach to one or more medical devices. In addition, each receptacle may comprise fastening means. Such fastening means may be a set screw or a cam. The fastening means may be arranged in the top surface to allow access to the fastening means from the top surface. The support structure may be formed to receive a medical device and secure it to the support structure after installation of the support structure.

The support structure may be formed of a material selected from the group consisting of titanium, stainless steel, carbon fiber, biocompatible materials and resorbable materials, and composites or combinations of these materials. Additionally, the support structure may include a central opening extending through and extending from the top surface thereof to the bottom surface. An anchor may be disposed in the central opening perpendicular to the top surface of the support structure. Alternatively, the support structure may comprise a central hinged claw having a threaded hinge connecting member and a nut disposed on the top surface. In use, when the nut is screwed onto the threaded hinge connecting member, the claw is closed by a pivoting movement about the hinge.

The medical device of the present invention may consist of two screw assemblies and a support structure, wherein each screw assembly comprises a base, an arm and interconnecting means for coupling the base to the arm. The interconnecting means allow the arm to be positioned in a first position parallel to the long axis of the base and in a second position perpendicular to the long axis of the base. In such embodiments, the base may be formed to attach to the patient's structure and the arm may be formed to attach to the support structure. In one embodiment, the structure to be attached is a bone. The support structure may also include a top surface, a bottom surface and two receptacles, each receptacle comprising an open end saddle shaped receptacle configured to be attached to a medical device (such as a screw assembly). The support structure may also include securing means for securing the medical device to the support structure after installing the support structure to the patient. The securing means may be a set screw or a cam. In addition, the securing means of this embodiment may comprise an anchor configured to attach to the structure of the patient. In one embodiment, the patient's structure is bone. The anchor may also be selected from the group consisting of screws, staples, hooks or nails.

A method of use of one aspect of the present invention for spinal support comprises the steps of: 1) moving two screw assemblies with arms, base and interconnecting means to a bone, and 2) securing means for arms of the screw assembly. Moving the support structure with the two receptacles close to the bone, 3) deploying the arms of the screw assembly, and 4) connecting the fastening means of the receptacles to secure the arms of the screw assembly to the support structure. It may include.

Another method of use of one aspect of the present invention for spinal support comprises the steps of: 1) moving two screw assemblies with arms, bases and interconnecting means into a bone, 2) a central opening with securing means, an anchor and Moving the support structure having two receptacles with fastening means for the arms of the screw assembly to the bone, 3) deploying the arms of the screw assembly, and 4) connecting the fastening means of the receptacles to the Securing the arm to the support structure.

Another method of use of one aspect of the present invention for spinal support comprises the steps of: 1) moving a screw assembly with an arm, a base and interconnecting means to a bone, 2) a central opening with fixing means, an anchor, Supporting the arm of the screw assembly by moving the support structure having a receptacle with a fastening means for the arm of the screw assembly to the bone, 3) deploying the arm of the screw assembly, and 4) connecting the fastening means of the receptacle Securing to the structure.

In a further embodiment, the support structure of the medical device of the present invention may comprise an anchor, a receptacle and a fixing means, wherein the anchor is formed to attach to the structure of the patient. The receptacle may comprise an open end attached to the medical device (eg screw assembly). The securing means may be configured to secure the medical device to the support structure after the support structure is deployed in the patient. In one embodiment, the patient's structure is bone. The securing means may be a set screw or a cam. The anchor may be selected from the group consisting of screws, staples, hooks or nails. In yet another embodiment, the receptacle may comprise a plurality of receptacles that receive the medical device.

In another aspect, a medical device for supporting a structure generally includes a screw assembly that includes a base and an arm. The arm may be a support formed to receive one or more anchor assemblies, wherein the anchor assembly includes means for securing it to the support. The support includes a top, a bottom and interconnection means for coupling the base to the support. The interconnecting means allow the support to be located in a first position parallel to the long axis of the base and in a second position perpendicular to the long axis of the base. The base and one or more anchor assemblies are formed to attach to the structure of the patient.

Embodiments of one aspect of the invention may include one or more of the following features. The structure supported by the medical device of the present invention can be selected from the group comprising the vertebrae, the femur, the tibia, the fibula, the humerus, the radius, the ulna, the calcaneus and the pelvis.

The screw assembly of the medical device of the present invention has an overall length formed to support the posterior part of the spine.

The base of the screw assembly may consist of a shaped base head, fastening means and an anchor. The shape of the base head may be open saddle shaped. The fixing means of the base may be composed of a set screw is formed to engage the support and the base, when fastening the set screw, it is possible to fix the support in a predetermined position relative to the long axis of the base. The anchor of the base can be selected from the group comprising screws, staples, nails, hooks and pins. In one embodiment, the anchor is a screw formed to secure the bone. In yet another embodiment, the anchor is a screw that is formed to be inserted into the bore of the vertebrae.

The support of the medical device of the present invention may have a shape selected from the group including board type, plate shape, elongated cross section, oval shape, square shape, I-beam shape and rod shape. The support may comprise a connector end, one or more openings and a receptacle. The connector end may be formed to interconnect the base and the support of the screw assembly. In one embodiment, the connector end is formed to hingeally interconnect the base and the support of the screw assembly.

One or more openings of the support may include a first connector end proximal aperture having a size that supports a range of motion of the base relative to the support. In addition, the one or more openings of the support may include means for securing the anchor assembly to the support and one or more second connector end distal apertures that allow access to the base when assembled with the support.

The support may comprise a support member having a top portion and a bottom portion, a head assembly, and interconnecting means. In one embodiment, the support member may comprise a receptacle and one or more openings. The one or more openings include a first opening through which the anchor assembly is penetrated and fixedly connected to the support member, and a second opening allowing access from an upper end of the support member for access to the head assembly.

The head assembly of the support may include a connector end, an opening having a size that supports the range of motion of the base relative to the support, and a connector end proximal opening having a size that supports the range of motion of the base relative to the support. The head assembly may also comprise fixing means for securing it to the support member, wherein the head assembly is formed to interconnect with the support member.

In another aspect, the present invention generally relates to 1) moving a screw assembly comprising a support having a receptacle, a base, interconnecting means, and securing means to the bone, and 2) a support perpendicular to the long axis of the base. Deploying, 3) penetrating one or more anchor assemblies with base and securing means through the support to implant into the bone, 4) securing the base into the one or more anchor assemblies, 5) one or more anchors Securing the assembly in the support receptacle; and 6) connecting the securing means of the screw assembly to fix the position of the support relative to the base.

In a further aspect, the present invention generally relates to a support member comprising: 1) a support member with a receptacle, a head assembly with a connector end, interconnecting means and fastening means for securing the head assembly to the support member; Moving the screw assembly to the bone, the screw assembly comprising an interconnecting means and a fixing means for securing the support in position with respect to the base, 2) deploying the support perpendicular to the long axis of the base, and 3) base and fixing Penetrating one or more anchor assemblies with means through the support to implant in the bone, 4) securing the base in the one or more anchor assemblies, 5) securing the one or more anchor assemblies in the support receptacles; 6) securing the head assembly to the support member, and 7) connecting the securing means of the screw assembly to the base. Characterized by a supporting bone structure comprises the step of fixing the position of the support.

In a further aspect, the present invention generally features a spinal support medical device comprising a screw assembly having a base, one or more arms, and interconnecting means for coupling the base to one or more arms. The interconnecting means allow one or more arms to be positioned in a first position parallel to the long axis of the base and in a second position perpendicular to the long axis of the base. The base is formed to attach to the patient's structure, and the one or more arms are formed to attach to the one or more support structures.

Embodiments of one aspect of the invention may include one or more of the following features. The patient's structure is bone. The entire length of the screw assembly may be formed to subcutaneously support the back of the patient. The base of the screw assembly may comprise a base head and an anchor.

The interconnecting means of the screw assembly may comprise a base head of the screw assembly, which may comprise a receptacle and a set screw. In one embodiment, the setscrew secures the base of the screw assembly to one or more arms. In another embodiment, the fastening of the setscrews allows for securing one or more arms of the screw assembly in position relative to the base. In one embodiment, the interconnecting means comprises a base head of the screw assembly, and the base head comprises hinge means.

One or more arms of the medical device of the present invention may comprise a body having an elongated shape, which body comprises a connector end attached to the support structure and a receiver end connected to the base head receptacle of the interconnecting means. do. In one embodiment, the elongate arm body may include an offset section that is formed to linearly align the base and the arm body when the arm is positioned parallel to the long axis of the base. In yet another embodiment, the elongate arm body has a shape that is formed to fit correlate between two or more arms positioned at a first position parallel to the long axis of the base. In yet another embodiment, the receptacle end of the one or more arms and the receptacle of the base head comprise hinge means. In another embodiment, means are provided for securing the arm in a position perpendicular to the long axis of the base. In one embodiment, the securing means of the arm may comprise a unidirectional ratchet, a set screw or a cam.

Embodiments of one aspect of the invention may include one or more of the following features. The screw assembly of the medical device of the present invention may comprise two arms, and the receiving end of these two arms may be formed to be interconnected. In one embodiment, one of the receptacle ends of the two arms comprises a first collet shaped receptacle end having a cylindrical groove, and the other receptacle end of the two arms is of the first collet type. And a cylindrical shape interconnected with the receiver. In yet another embodiment, one of the receptacle ends of the two arms may comprise a first collet receptacle end having a spherical groove, and the other receptacle end of the two arms is of the first collet type. It may comprise a spherical shape interconnected with the receiving portion.

In one embodiment, the invention may include the following features. One or more support structures of the medical device of the present invention may include an anchor, an opening formed to attach the arm of the screw assembly, and fastening means formed to secure the arm of the screw assembly to the support structure.

In another embodiment, the present invention may include the following features. The interconnecting means of the screw assembly may comprise a hinge, a pin or a collet.

In another aspect, the present invention generally relates to 1) moving a screw assembly with one or more arms, bases and interconnecting means to a bone, and 2) one or more means with openings and fixing means for the arms of the screw assembly. Moving the support structure to a flanking bone, 3) deploying one or more arms of the screw assembly to the positioning support structure, 4) securing one or more arms of the screw assembly to a predetermined position, 5 ) Connecting the fixation means of the opening of the support structure.

Aspects of the invention may include one or more of the following beneficial features. According to various embodiments of the invention, the support and the screw assembly may be preassembled together. This eliminates the need to connect the support and the screw assembly during the procedure. According to this, the user's operation is almost unnecessary. For example, the screw assembly may first be inserted into the lumbar vertebrae. Subsequently, the support connected to the screw assembly by the interconnecting means can be deployed to a predetermined position. Subsequently, one or more anchor assemblies may be further provided to allow attachment with another vertebra.

In various embodiments of the present invention, the deviation region of the arm body may be formed such that the profile of the screw assembly becomes small when one or more arms are positioned parallel to the long axis of the base. This small profile is desirable because the arms of the screw assembly and the medical device can be easily positioned as a single unit in a minimally invasive manner, for example through narrow access channels, ports or cannulaes.

Hereinafter, one or more embodiments of the present invention will be described in detail with reference to the accompanying drawings. Other features, objects, and advantages of the invention can be apparent from the specification, drawings, and claims of the invention.

1A is a view of a screw assembly showing the screw assembly, arms and base in a first position.

1B shows the screw assembly in a second position.

Figure 1c shows a screw assembly with press-fit cross pin type interconnect means.

1D shows an open saddle-shaped base head.

1E shows an integral cross piece.

Figure 1f is a view showing the indentation cross pin.

2A illustrates the support structure.

2b shows a support structure with a central opening and an anchor.

2C shows a support structure with a hinged claw.

Figure 3a shows two screw assemblies connected by a support structure.

FIG. 3B shows a state where two screw assemblies are connected by a support structure and implanted into the lumbar vertebrae. FIG.

4 shows one screw assembly connected to a support structure having a central opening and an anchor.

FIG. 5 shows one screw assembly connected to the base with an open saddle head. FIG.

FIG. 6 illustrates cannula and support structure tools used to implant screw assemblies and support structures. FIG.

FIG. 7 illustrates a screw assembly tool used to manipulate a screw assembly during implantation of the screw assembly into the spine.

8A shows the support assembly.

8b to 8c are diagrams illustrating a screw assembly having a base and a support, wherein the support and the base are interconnected but the support is positioned and connected in parallel (FIG. 8b) or vertically (FIG. 8c) with the major axis of the base. Figures shown.

8D is a view of the support.

9A is a view of another support assembly.

9B-9E illustrate the screw assembly.

FIG. 10A is a cut away view of the anchor assembly before it is secured in the support. FIG.

FIG. 10B is a cut away view of the anchor assembly after being secured in the support. FIG.

11A-11C illustrate a screw assembly.

11D is a cross sectional view of the screw assembly.

11E illustrates the screw assembly.

12A and 12B are cross-sectional views of the screw assembly.

Figure 12C is a view of a screw assembly showing a spherical collet connection between two arms and showing the base in cross section.

12D is a cross sectional view of the screw assembly showing a spherical collet connection between two arms.

Figure 13A is a view of a support assembly showing a screw assembly with one arm and a base attached to the support structure.

FIG. 13B is a view of a support assembly showing a screw assembly with two arms and a base attached to two support structures. FIG.

14 shows a support assembly implanted within the lumbar vertebrae.

In the drawings, the same members are denoted by the same reference numerals.

As shown in Figs. 1A and 1B, a screw assembly 1 consisting of an arm 2 and a base 3 is provided as a single unit. The screw assembly 1 is long and the arm 2 and the base 3 of the screw assembly 1 are joined by interconnection means 4. 1A and 1B, the interconnecting means 4 facilitate the movement between the arm 2 and the base 3 so that the arm 2 is parallel to the long axis of the base 3. It can be located in one first position (FIG. 1A) and in a second position (FIG. 1B) perpendicular to the long axis of the base 3. The base 3 of the screw assembly 1 is formed to be attached to a structure (for example bone), and the arm 2 is formed to be attached to the support structure 10 (described below). In application, one or more screw assemblies 1 are attached to the support structure 10. Preferably, two screw assemblies 1 are attached to a single support structure 10.

In an embodiment of an alternative screw assembly 1, the arm 2 and base 3 of the screw assembly 1 are formed as one continuous member formed of a shape memory metal. In this embodiment, the interconnecting means 4 are shaped so that the arm 2 can easily move relative to the base 3 in accordance with predetermined conditions affecting the shape of the shape memory metal (not shown). It is formed of memory metal. In another embodiment of the screw assembly 1, the arm 2 and the base 3 of the screw assembly 1 are formed as one continuous member, with the mutual between the arm 2 and the base 3. The connecting means 4 are formed of a material (not shown) suitable for bending.

As shown in FIG. 1A, in some embodiments the arm 2 of the screw assembly 1 consists of a body 17, a base yoke 18 and a connector end 12. The body 17 of the arm 2 can change its shape and length in application. In one embodiment, the body 17 of the arm 2 is rod-shaped (see FIGS. 1A and 1B). Alternatively, the body 17 of the arm 2 is shaped to fit within a screw assembly tool for manipulating the screw assembly 1. An example of such a screw assembly tool 19 is shown in FIG.

The screw assembly 1 may be made of various materials that can be implanted in the human body and have durability, and examples of such materials include titanium, stainless steel, carbon fiber, biocompatible materials, and the like. In one embodiment, the screw assembly 1 is made of titanium. In addition, the screw assembly 1 may be made of a reabsorbable material or a shape memory metal. Alternatively, the screw assembly 1 may be a composite or a combination of the aforementioned materials. The size of the screw assembly 1 may vary from application to application. Generally, the length of the screw assembly 1 is 0.1 cm to 100 cm. In one embodiment, this length is between 50 mm and 600 mm. In yet another embodiment, the screw assembly 1 is adapted to support the back of the spine 28 (see FIG. 3B).

As shown in FIG. 1A, the base 2 of the screw assembly 1 consists of a base head 20 and an anchor 14. The anchor 14 may be a screw, staple, hook or nail and may be of the type typically used for securing bones. In one embodiment, the anchor 14 is a screw inserted into the bore 26 of the vertebrae 27 (see FIGS. 1A and 3B).

As shown in FIG. 1C, the interconnecting means 4 of the screw assembly 1 of FIG. 1A may be of the press-fit cross pin type. In this embodiment, the base head 20 is a press-fit cross pinned head 5, the yoke 18 of the arm 2 comprises a pin hole 25, and the arm 2 and the base 3 are Preassembled using press-fit cross pins (not shown) and set screws 9 (not shown). In another embodiment, as shown in FIGS. 1D-1F, the interconnecting means 4 of FIG. 1A is formed as an open saddle head with a mating cross piece. In this embodiment, the base head 20 is formed as an open saddle head 6 (see FIG. 1D) that is preassembled with the complementary arm 2. As shown in FIG. 1E, the arm 2 formed complementary to the open saddle head 6 may be an integral cross piece 7. Alternatively, as shown in FIG. 1F, the complementary arm 2 may be a press-fit cross pin 8.

As shown in Figures 1A and 1B, the arm 2 and the base 3 can be held together as a single unit by a set screw 9, wherein the interconnecting means 4 are press-fit cross pins or It is in the form of an open saddle head with a mating cross piece. In some embodiments, a screw is formed in the open saddle head to accommodate the set screw 9.

Also, as shown in Figs. 1A and 1B, the set screw 9 can fix the arm 2 to a fixed position. Before moving the arm 2 to the deployed position, the set screw 9 is installed in place. In deployment, by fastening the set screw 9 into the threaded open saddle head 6 of the base 3 (see FIG. 1D), the arm 2 can be fixed in a position perpendicular to the long axis of the base 3. have.

In one embodiment, a cam (not shown) may be used in place of the set screw 9 to secure the arm 2 and hold the arm 2 and the base 3 together as a single unit. In the case where the cam replaces the set screw 9, the fixation of the arm 2 and the engagement of the arm 2 and the base 3 are achieved by similar means to each other.

2A-2C, 3A, 3B and 4, the support to which the connector end 12 (see FIGS. 3A, 3B and 4) of the arm 2 of the screw assembly 1 can be attached The structure 10 is shown. As shown in FIG. 2A, the support structure 10 includes a top surface 15, a bottom surface 16, one or more open end saddle receptacles 11 and a set screws 9 for fastening or alternatively. It consists of a cam. The receptacle 11 is formed to receive the connector end 12 of the arm 2 of the screw assembly 1. As shown in FIGS. 2A and 2B, the set screw 9 is perpendicular to the top surface 15 of the support structure 10 to facilitate access to the set screw 9 from above the support structure 10. Is fastened into the support structure 10. In one embodiment, the support structure 10 consists of two receiving portions 11 (see FIGS. 2A-2C, 3A, 3B and 4) so that the two screw assemblies 1 support the structure. Through (10) it can be connected together (see Figure 3a). In another embodiment, as shown in FIG. 3B, the two screw assemblies 1 connected together through the support structure 10 may support the vertebrae 27 of the spine 28 so as to support the spine 28. It can be implanted in the cardinal 26.

As shown in FIGS. 2B and 4, the support structure 10 may be formed to include a central opening 13 penetrating from its top surface 15 to its bottom surface 16. As shown in Figures 2B and 4, the central opening 13 may be threaded to receive the anchor 14, optionally with a cam or set screw for securing the anchor 14 in place. And (9). In this embodiment, the threaded portion of the central opening 13 and the set screw 9 of the receptacle 11 are aligned perpendicular to the top surface 15 of the support structure 10. Anchor 14 may be a screw, staple, hook or nail and may be of the type typically used for securing bone. In one embodiment, the anchor 14 is a screw that is inserted into the lumbar vertebrae.

In another embodiment, as shown in FIG. 2C, the support structure 10 may optionally include a hinged claw 21 that secures it on a surface (eg, the surface of a bone). The claw 21 has a hinge 22 located between two receiving portions 11 of the support structure 10. The claw 21 includes a threaded connection member 23 extending above the top surface 15 of the support structure 10, which, when fastening a nut (not shown) to the connection member 23, hinge 22. The claw 21 is closed while the pivoting movement about the center is achieved.

The support structure 10 may be made of various materials that can be implanted into the human body and have durability, and examples of such materials include titanium, stainless steel, carbon fiber, biocompatible materials, and the like. Preferably, the screw assembly 1 is made of titanium. In addition, the support structure 10 may be made of a resorbable material. Alternatively, the support structure 10 may be a composite or combination of the aforementioned materials.

As shown in FIG. 5, in another embodiment of the present invention, a single screw assembly 1 is connected to a support structure 10 having a receiving portion 11, an anchor 14 and a fixing means. In one embodiment, the receiving portion 11 is formed as an open saddle head 6. In yet another embodiment, the support structure 10 comprises a plurality of receptacles 11. The fastening means may comprise a set screw 9 or alternatively a cam. In one embodiment, the connector end 12 of the screw assembly arm 2 is fixed in the open saddle-shaped receiver head 6 of the support structure 10 after the anchor is installed in the patient.

As shown in Figure 6, the method of using the present invention to support the vertebrae 28 includes: 1) forming a series of small incisions to connect the cannula 29 to the portion of the lumbar 26 of the series of vertebrae 27; 2) moving the two undeveloped screw assemblies 1 along the cannula 29 access path to a series of cardinals 26 and fastening them within each cardinal 26; The term deployment refers to the construction of a screw assembly where each arm is positioned in a position parallel to the long axis of the base), 3) the support structure tool 30 along the access path of the cannula 29 to lock in place. Fixing the support structure 10 having a central opening, a set screw and two receptacles with a set screw and an additional screw-type anchor, and 4) arm of each screw assembly 1 perpendicular to the long axis of the base. 5) connector stage of each arm A screw assembly using the linking in the support structure 10 and a fixing in place.

This method involves the use of a specific screw assembly tool 19 for the manipulation of the screw assembly 1 (see FIG. 7). The screw assembly tool 19 includes an inner cavity 24 formed to receive an undeveloped screw assembly. In use, the screw assembly tool 19 allows the undeveloped screw assembly base to be easily inserted into a structure (eg bone) in the cannula 29 area (see FIG. 6).

A further method of use of the present invention for spinal support comprises the steps of: 1) moving two screw assemblies with arms, base and interconnecting means to the bone, and 2) two fixing means for screw assembly arms. Moving the support structure with the receptacle close to the bone, 3) deploying the arm of the screw assembly, and 4) connecting the securing means of the receptacle to secure the arm of the screw assembly to the support structure. can do.

Another method of use of the present invention for spinal support comprises the steps of: 1) moving two screw assemblies with arms, bases and interconnecting means to the bone, 2) a central opening with fastening means, an anchor, and a screw assembly Moving the support structure having two receptacles with securing means for the arms to the bone, 3) deploying the arms of the screw assembly, and 4) connecting the securing means of the receptacles to support the arms of the screw assembly. It may comprise the step of fixing to.

Another method of use of the invention for spinal support comprises the steps of 1) moving a screw assembly with arms, bases and interconnecting means to a bone, 2) a central opening with securing means, an anchor, and a screw assembly arm Moving the support structure having a receptacle with fixing means for securing to the bone, 3) deploying the arm of the screw assembly, and 4) connecting the securing means of the receptacle to secure the arm of the screw assembly to the support structure. It may include a step.

As shown in FIGS. 8A and 9A, the base 102, the support 103 formed to receive one or more anchor assemblies 301, and the interconnecting means between the base 102 and the support 103 ( There is provided a screw assembly 101 comprising a 105. As shown in Figures 8A, 8C, 8D and 9A-9E, the support 103 includes a top 107 and a bottom 108 (Figs. 8B, 8C, 9D and 9E). Reference). The interconnecting means 105 is characterized in that the support 103 is located in a first position parallel to the long axis of the base 102 (see FIGS. 8B and 9B-9D) and subsequently perpendicular to the long axis of the base 102. To be deployed or positioned (see FIGS. 8A, 8C and 9A-9E). The base 102 and one or more anchor assemblies 301 of the screw assembly 101 are formed to attach to the patient's structure (eg, bone). In application, the screw assembly 101 receives one or more anchor assemblies 301 to form the support assembly 106 (see FIGS. 8A and 9A). In one embodiment, the anchor assembly 301 is coupled with the screw assembly 101 after deployment of the support 103 (which forms the support assembly 106), and in another embodiment the anchor assembly 301 is a screw It is preassembled with the assembly 101. One advantage of the present invention over the prior art is that it can save time when using the support assembly 106 to support the structure. Another advantage is that removal is relatively easy. Support assembly 106 may be used for temporary or permanent implantation.

After assembly, support assembly 106 may be used to support the bone structure. Such supporting bone structures include other bones of the femur or leg (e.g. tibia and fibula), bones of the arm and wrist (e.g. humerus, radial and ulna) and other such as calcaneus, pelvis, spine (vertebrae) Another bone. It may support a single bone (ie, long bones such as the femur, tibia, humerus) or one or more bones (ie, the vertebrae).

The screw assembly 101 may be made of materials that can be implanted into the human body and have durability, and examples of such materials include titanium, stainless steel, carbon fiber, and the like. In one embodiment, the screw assembly 1 is made of titanium. In yet another embodiment, the screw assembly 101 is made of a biocompatible material, a resorbable material or a composite or combination of the aforementioned materials. The size of the screw assembly 101 may vary from application to application. In general, the length of the screw assembly 101 is 20 mm to 1,000 mm. In one embodiment, this length is from 50 mm to 400 mm. In yet another embodiment, the screw assembly 101 is adapted to support the back of the spine (not shown).

As shown in FIGS. 8A-8C, 9A-9E and 10A-10B, the base 102 of the screw assembly 101 has a shaped base head 114, fastening means and anchors 109a. It consists of. Base head 114 may be formed in any shape, as long as it is suitable for receiving or interconnecting support 103. In one embodiment, the base head 114 is an open saddle head. As shown in Figures 8A, 8C and 9A, in one embodiment the securing means of the base head 114 may be a set screw 104. The set screw 104 may be formed to connect the base 102 and the support 103 while ensuring free movement between the base 102 and the support 103 (see FIGS. 8A, 9A and 9E). . The fixing means may fix the support 103 in a fixed position relative to the base 102. In one embodiment, the set screw 104 may be fastened to secure the support 103 at a location relative to the base 102 (eg, the major axis of the base). In another embodiment, the securing means of the base head 114 may be a cam (not shown).

As shown in Figures 8A-8C, 9A-9E and 10A-10B, the anchor 109a of the screw assembly 101 may be selected from the group consisting of screws, staples, nails, hooks and pins. have. In one embodiment, the anchor 109a is formed to secure the bone. In yet another embodiment, the anchor 109a is a screw formed to be inserted into the bore of the vertebrae.

As shown in Figures 8A, 9A and 10A-10B, the anchor assembly 301 is formed to be interconnected with the receiving portion 306 (described in detail below). The anchor assembly 301 may be formed in any shape. In some embodiments, the support 103 and anchor assembly 301 correspond only in two sizes (eg, when the curved receiving portion 306 is used by 90 degrees). As shown in FIGS. 10A and 10B, the anchor assembly 301 may be comprised of a head 302, a base 109b and a base head 114. The anchor assembly 301 may be made of a variety of materials that can be implanted into the human body and have durability, such as titanium, stainless steel, carbon fiber, and the like. In addition, the anchor assembly 301 may be made of a resorbable material, a biocompatible material, or a composite or combination of the aforementioned materials.

As shown in FIGS. 10A and 10B, the anchor assembly 301 includes means for securing it to the support 103. In one embodiment, as shown in Fig. 10A, when the complementary head 302 of the receiving portion 306 and the anchor assembly 301 is formed in a T-shaped slot shape, the anchor assembly 301 fixing means. May be a set screw fastened into the head 302 of the anchor assembly 301, where the head 302 includes a threaded base opening 305 and a deformable portion. Such means for securing the anchor assembly 301 to the support 103 is disclosed in US patent application Ser. No. 11 / 019,918. As shown in Fig. 10B, when the set screw 104 is pivoted into the threaded base opening 305, the deformable head 303 unfolds outwards, so that the T-shaped slot shape of the head 302 receives the receiving portion ( It is fixed against the planar intermediate surface 308 of 306. As shown in FIGS. 10A and 10B, the set screw 104 may be disposed to be constrained within the threaded base opening 305. The set screw 104 constrained in this way causes the deformable head 303 to spread outward while being excessively pressed during final tightening. In another embodiment, the head 302 may also be secured against the planar top surface 309 or planar bottom surface 307 of the receptacle 306 or both. In another embodiment, a cam can replace the set screw 104 to secure the anchor assembly 301 within the support 103 (not shown).

The deformable portion of the deformable threaded base opening 305 may be formed as a void in the anchor assembly 301 head 302, which cavity may include a cavity, slot notch, groove, incision, gap, and groove. Can be selected. In one embodiment, this cavity is tapered. In another embodiment shown in FIG. 9A, the cavity in the head 302 of the anchor assembly 301 may be a slot 313 cut and formed in the head 302.

As another means for securing the anchor assembly 301 to the support 103, including the means disclosed in US Patent Application No. 10 / 826,684, filed April 16, 2004, entitled “Subcutaneous Support” as the name of the invention. Means are possible.

As shown in FIGS. 10A and 10B, the anchor assembly 301 includes a base 102 movably disposed within the threaded base opening 305. Base 102 may be a screw, staple, hook or nail, and may be of the type typically used for fastening with a structure (eg bone). In one embodiment, base 102 is a screw that is inserted into the lumbar vertebrae. In yet other embodiments, base 102 may be attached to other bone structures.

Base 102 may be attached to anchor assembly 301 in a number of ways. In one embodiment, this attachment is accomplished by a hinged connection between the base 102 and the anchor assembly 301 (see eg FIGS. 1A and 1B). In another embodiment, as shown in FIGS. 10A and 10B, a multiaxial base head 114 of base 102 is attached to complementary receptacle 304 in anchor assembly 301 head 302. .

The anchor assembly 301 also includes means for securing the base 102 in the anchor assembly 301 head 302. As shown in FIGS. 10A and 10B, for the multiaxial base head 114, the securing means may comprise a set screw 104 disposed in the threaded base opening 305. According to this configuration, when the set screw 104 is pivoting, the set screw 104 directly presses the multiaxial base head 114 of the base 102 so that the base head is connected to the receptacle 304 of the anchor assembly 301. It is fixed by pressing against. Alternatively, in the case where the base 102 is hinged, the securing means may consist of set screws 104 disposed in the threaded base opening 305. According to this configuration, when the set screw 104 is rotated, the set screw 104 directly presses the base head 114 of the hinged base 102 to generate frictional force against the hinge pin (not shown), thereby fixing it. Let's go. In another embodiment, the set screw 104 may be substituted and secured with a cam.

As shown in FIGS. 10A and 10B, in another embodiment of the anchor assembly 301, the anchor assembly 301 may be a longitudinal opening 312, base head 114, tool interface of the base 102. 311 and the set screw opening 310. The longitudinal opening 312 and the set screw opening 310 are formed such that the instrument, wire (eg, K-wire) or other guide device can penetrate the entire anchor assembly 301. The set screw opening 310 is also formed such that a tool or instrument can be connected to the tool interface 311 of the base 102 through the set screw opening 310. Alternatively, the set screw 104 may be a cam (not shown).

The set screw opening 310 may have any shape and may be sized to enable the use of objects and tools and to accommodate through paths without affecting the position of the set screw 104.

The longitudinal opening 312 may have any desired cross-sectional shape, including circular, square, hexagonal, elliptical, or any regular or irregular shape.

The tool interface 311 may be formed in any shape suitable for receiving a tool for manipulating the base 102. For example, where base 102 is a screw, tool interface 311 can be hexagonal or any shape commonly used for screw head tool interfaces.

Once the anchor assembly 301 is formed as shown in FIGS. 10A and 10B, the set screws 104 may be preliminarily positioned in the base opening 305 without being securely fastened. The set screw opening 310 and the longitudinal opening 312 (through the base 102 and the base head 114) allow access through the preassembled anchor assembly 301. In addition, when the anchor assembly 301 is pre-assembled, it becomes accessible to the tool interface 311 of the base head 114 through the set screw opening 310.

As shown in Figs. 8A, 8D, 9A, 9D and 9E, the support 103 has a predetermined shape. The shape of the support 103 may be selected from the group consisting of board, plate, long cross section, oval, square, I-beam and rod. In one embodiment, as shown in Figures 8A, 8D, 9A, 9D and 9E, the support is formed in a plate shape. In one embodiment, the length of the support 103 is formed to the length necessary to include at least two vertebrae. In one embodiment, the support 103 is formed to the length necessary to include three vertebrae. In yet another embodiment, the length of the support 103 is between 25 mm and 140 mm.

As shown in FIGS. 8A-8D, in one embodiment, the support 103 consists of a connector end 110, one or more openings 111, and a receptacle 306. The connector end 110 is formed to interconnect the support 103 and the base 102 of the screw assembly 101. In one embodiment, the connector end 110 is formed to hingeally interconnect the support 103 and the base 102 of the screw assembly 101.

As shown in FIGS. 8A, 8B and 8D, in one embodiment, one or more openings 111 of support 103 are positioned close to connector end 110 with respect to support 103. A first opening 111c and a second opening 111a positioned spaced apart from the connector end 110 with respect to the support 103. As shown in FIGS. 8A, 8B and 8D, the first opening 111c may support a range of motion of the base 102 relative to the support 103. In one embodiment, the movement of the base 102 relative to the support 103 includes a hinged movement (see FIGS. 8A-8C). As shown in FIG. 8A, the second opening 111a secures the access path to the base 103 and the anchor assembly 301 to the support 103 when the anchor assembly 301 is assembled with the support 103. Means can be formed. In one embodiment, the second opening 111a may form an access path from the top to the support 103 after the support 103 is deployed to a position perpendicular to the base 102.

As shown in FIGS. 8A and 8D, in one embodiment, the receiving portion 306 is disposed within the long axis of the support 103. In another embodiment, the receptacle 306 is connected to the upper end 107 or the bottom 108 of the support 103. In yet another embodiment, the receptacle 306 is formed over the length of the support 103. Receiving portion 306 may be formed in any of a variety of designs and shapes. In one embodiment, the receptacle 306 may have a configuration selected from the group consisting of slots, grooves, tracks, dovetails and snap-ins. In yet another embodiment, the receptacle 306 has a curved configuration at 90 degrees. In yet another embodiment, the receptacle 306 and anchor assembly 301 are formed in an interconnection that includes a T-shaped slot (see FIGS. 10A and 10B). As shown in FIGS. 10A and 10B, in one embodiment, the T-shaped slot portion of the receiving portion 306 may be composed of a planar top surface 309, a planar bottom surface 307, and a planar intermediate surface 308. Can be. Receiving portion 306 may comprise two ends, one or both of which are open or closed (not shown).

As shown in FIGS. 9A-9E, in one embodiment, the support 103 consists of a support member 202, a head assembly 201 and interconnecting means 105 (eg, slot-flange combination). . The support member 202 may include a top portion 107 and a bottom portion 108 and one or more openings 111 (see FIGS. 9A-9E). As shown in FIGS. 9A-9C, in one embodiment, the support member 202 includes a receptacle 306 and one or more openings 111.

As shown in FIG. 9A, in one embodiment, the receiving portion 306 is disposed within the long axis of the support member 202. In another embodiment, the receptacle 306 is connected to the top 107 or bottom 108 of the support member 202 (eg, as an attachment). In yet another embodiment, the receptacle 306 is formed over the length of the support member 202. Receiving portion 306 may be formed in any of a variety of designs and shapes. In one embodiment, the receptacle 306 has a configuration selected from the group consisting of slots, grooves, tracks, dovetails and snap-ins. In yet another embodiment, the receptacle 306 has a curved configuration at 90 degrees. In yet another embodiment, the receptacle 306 and the head assembly 201 are formed in an interconnection that includes a T-shaped slot (see FIGS. 10A and 10B). As shown in FIGS. 10A and 10B, in one embodiment, the T-shaped slot of the receiving portion 306 consists of a planar top surface 309, a planar bottom surface 307, and a planar intermediate surface 308. Can be.

Receiving portion 306 may comprise two ends, the first of the two ends being open and the second end being closed (not shown). Alternatively, both ends can be open or closed (not shown).

9A-9C, in one embodiment, the one or more openings 111 of the support member 202 allow the anchor assembly 301 to pass through to be secured with the support member 202. It has a first opening 111a to be connected. A second opening 111b may be included to allow access from the upper end 107 of the support member 202 to the bottom 108 of the support member 202 (see FIGS. 9A-9C). As shown in FIGS. 9B and 9C, the second openings 111b allow access to the head assembly 201 of the support 103 when the head assembly 201 is interconnected with the support member 202.

As shown in FIGS. 9A-9C, in one embodiment, the head assembly 201 is formed to interconnect with the support member 202 and the base 102. The head assembly 201 includes a connector end 110, an opening 111c and fixing means (eg a flange) for fixing the head assembly 201 to the support member 202. In one embodiment, the receptacle 306 and the head assembly 201 of the support member 202 are formed of interconnects that include T-shaped slots. The interconnection between the head assembly 201 and the support member 202 allows the support member 202 to be adjustablely positioned (and / or fixed) along the long axis of the head assembly 201 (FIGS. 9B and 9c). As shown in FIG. 9B, the head assembly 201 may be retracted within the support member 202 to reduce the overall length of the screw assembly 101. On the other hand, as shown in FIG. 9C, the head assembly 201 may extend relative to the support member 202 to increase the overall length of the screw assembly 101.

The connector end 110 of the head assembly 201 may be formed to interconnect the support 103 and the base 102 of the screw assembly 101. In one embodiment, the connector end 110 is formed to hingeally interconnect the support 103 and the base 102 of the screw assembly 101 (see FIGS. 9A-9E).

As shown in FIGS. 9A-9C, the opening 111c of the head assembly may be sized to support the range of motion of the base 102 relative to the support 103. Also, as shown in FIGS. 9A-9C, the securing means for securing the head assembly 201 to the support member 202 may be comprised of a set screw 104 disposed within the head assembly 201. In use, pivoting the set screw 104 causes the set screw 104 and the support member 202 to contact and fix the head assembly 201 to the support member 202. Alternatively, in another embodiment, the securing means for securing the head assembly 201 to the support member 202 may be composed of a cam.

The method of use of the invention for supporting a bone structure comprises the steps of 1) moving a screw assembly comprising a support, a base, interconnecting means and a securing means with a receptacle to the bone, and 2) deploying the support perpendicular to the long axis of the base. 3) penetrating at least one anchor assembly with a base and securing means through the support to implant into the bone, 4) securing the base within the at least one anchor assembly, 5) at least one anchor assembly; Securing the anchor assembly in the support receptacle; and 6) connecting the fixing means of the screw assembly to fix the position of the support relative to the base.

In a further embodiment, the method may include placing the support adjacent to the bone or spine. In one embodiment, the method may include placing the support in a subcutaneous fat layer, such as the back. In another embodiment, the method may include disposing the support outside the body.

Another method of use of the invention for supporting a bone structure comprises: 1) a support comprising a receptacle, a head assembly having a connector end and a support comprising an interconnecting means, a base, an interconnecting means and a securing means. Moving the comprising screw assembly to the bone, 2) deploying the support perpendicular to the long axis of the base, and 3) implanting one or more anchor assemblies with base and securing means through the support and implanted into the bone. 4) securing the base in one or more anchor assemblies, 5) securing one or more anchor assemblies in the support receptacle, 6) securing the head assembly in the support member, and 7) screw assembly of the screw assembly. Connecting the fixing means to fix the position of the support relative to the base.

In one embodiment, the method may include placing the support adjacent to the bone or spine. In one embodiment, the method may include placing the support in a subcutaneous fat layer, such as the back. In yet another embodiment, the above method may include disposing a support outside the body.

The method of use of the invention for forming a predetermined intervertebral disc spacing comprises the steps of: 1) implanting a screw assembly comprising a support, a base, an interconnecting means and a securing means with a receptacle into the bone, and 2) a long axis of the base. Deploying perpendicularly to, 3) penetrating one or more anchor assemblies with base and securing means through the support to implant into the vertebrae, and 4) interconnecting the anchor assembly with the receptacle of the support. Not securing the assembly in the receptacle, 5) compressing or spaced apart the base of the screw assembly and the base of the anchor assembly relative to each other (e.g., to displace the vertebrae in which the device is installed in parallel), and 6) the anchor assembly. Fastening in the support (e.g. using a set screw or cam), and 7) using a screw assembly fastening means. (Using e.g. a set screw or a cam) may include the step of fixing the position of the support on the base.

As used herein, the term “device installed” refers to the physical connection of a structure (eg, a vertebral bone) with a medical device or instrument.

The method of use of the present invention for forming a desired spine curvature comprises the steps of: 1) implanting a screw assembly comprising a support, a base, an interconnecting means and a fixing means with a receptacle into the spinal column, and 2) a long axis of the base. Deploying perpendicularly to, 3) penetrating one or more anchor assemblies with base and securing means through the support to implant into the vertebrae, and 4) interconnecting the anchor assembly with the receptacle of the support. Not securing the assembly in the receptacle, 5) compressing or spaced the bases relative to each other (eg to form a pre / post curvature of the spine), and 6) anchoring the assembly (e.g. a set screw or cam). Using a screw assembly fixing means (e.g., using a set screw or a cam). For it may include the step of fixing the position of the support.

As shown in FIGS. 11A-11C and 11E, a screw assembly 1101 is provided that includes a base 1102 and one or more arms 1103 as a single unit. The base 1102 and the arm 1103 of the screw assembly 1101 are joined by interconnection means. Base 1102 of screw assembly 1101 is formed to attach to a structure (eg, a bone) and arm 1103 is formed to attach to a support structure (described in detail below). In application, a screw assembly 1101 with one or more arms 1103 is attached to one or more support structures to form a support assembly 1301 (see FIGS. 13A and 13B). Support assembly 1301 may be used for temporary or permanent implantation.

As shown in FIGS. 11A and 11B, the screw assembly 1101 interconnecting means may cause the arm 1103 to freely rotate (or multiaxial) with respect to the base 1102. Such interconnecting means may be selected from, but not limited to, a variety of means including hinge means, collet means and pins. As shown in FIGS. 11A and 11B, the interconnecting means includes a receptacle end 1112 disposed in the receptacle 1202 of the base 1102. According to this configuration, the arm 1103 may have a spherical receiver end 1112 connected to the complementary receiver 1202 of the base head 104. In addition, base head 1104 may be sealed or open (eg, the open saddle shown in FIG. 1A). The free rotational movement of the arm 1103 by the interconnecting means is a conical range of motion with an axis, and the free rotational movement is carried out about this axis (hereinafter referred to as "conical axis").

In use, the embodiment shown in FIGS. 11A and 11B can be used to support a patient's bone structure (eg, a spine with a series of vertebrae). If the structure so supported is the spine and the spine includes a long axis (hereinafter referred to as the "vertebral axis"), the screw assembly 1101 may support the spine in line with the spinal axis. More specifically, the conical axis for the movement of the arm 1103 of the screw assembly 1101 may optionally be arranged such that the conical axis is collinear with the spinal axis. According to this configuration, it is possible to adjust the position when placing the base 1102 and the arm 1103 of the screw assembly 1101 with respect to the structure (such as a series of vertebrae) to be supported. For example, if three consecutive vertebrae are to be supported by a support assembly 1301 comprising a screw assembly 1101 with two arms 1103 and two support structures (described in detail below). At three attachment points to the three vertebrae can be linear. Alternatively, the three attachment points do not necessarily need to be linear.

In another embodiment, as shown in FIGS. 11C and 11E, the interconnecting means may include one or more receptacle ends 1112 of one or more arms 103 disposed within the base head 1104 of the base 1102. Include. In this embodiment, the interconnecting means is provided in which the arm 1103 is perpendicular to the first position (FIGS. 11D, 12B and 12D) parallel to the long axis of the base 1102 and the long axis of the base 1102. Movement between the arm 1103 and the base 1102 can be facilitated to be located in two positions (FIGS. 11C and 11E). In addition, the screw assembly 1101 interconnecting means allows the arm 1103 to easily freely rotate (or multiaxial) with respect to the base 1102. As described above, the free rotational movement of arm 1103 may be a conical range of motion with a conical axis. In use, the embodiment shown in FIGS. 11C and 11E can be used to support a patient's bone structure (eg, a spine with a series of vertebrae). As described in the above embodiment shown in Figs. 11A and 11B, this embodiment can be used to support the spine collinearly with the spinal axis. Alternatively, as shown in Figs. 12C and 12D, in an embodiment that is collinear with the vertebral axis, the cone axis for the movement of the arm 1103 of the screw assembly 1101 is such that the conical axis is It may be arranged to be positioned vertically. According to this configuration, control and advantages similar to those of the arm 1103 described with respect to the embodiment shown in Figs. 11C and 11E are obtained.

The screw assembly 1101 may be made of materials that can be implanted into the human body and have durability, and such materials include titanium, stainless steel, carbon fiber, and the like. In one embodiment, screw assembly 1101 is made of titanium. In yet another embodiment, screw assembly 1101 is made of a biocompatible material, a resorbable material, or a combination of the aforementioned materials. The size of the screw assembly 1101 may vary from application to application. In general, in the embodiment shown in FIGS. 11C and 11E, the arm 1103 may be positioned in a first position parallel to the long axis of the base 1102, and the length of the screw assembly 1101 may be between 20 mm and 1,000. mm. In one embodiment, this length is from 50 mm to 400 mm. In yet another embodiment, screw assembly 1101 is adapted to support multiple points in the posterior vertebrae (see FIG. 14). In another embodiment, as shown in FIGS. 11A and 11B, the length of the base 1102 is 20 mm to 100 mm, and the length of one or more arms 1103 is 20 mm to 600 mm. In yet another embodiment, the length of base 1102 and the length of arm 1103 are 20 mm to 600 mm, respectively. In yet another embodiment, the combined length base 1102 and the arm 1103 are applied to support multiple points in the back of the spine (see FIG. 14).

In one embodiment, as shown in FIGS. 11D, 12B, and 12D, the screw assembly 1101 includes a longitudinal opening 1106. The longitudinal opening 1106 is formed over the length of the screw assembly 1101, and the arm 1103 is to be positioned in a first position parallel to the long axis of the base 1102 (see FIGS. 1D, 2B and 2D). An opening through which the instrument, tool, and guiding device (eg, K-wire) passes.

As shown in FIGS. 11A-11C and 11E, the base 1102 of the screw assembly 1101 is composed of a base head 1104 and an anchor 1105. Anchor 1105 may be a screw, staple, hook or nail and may be of the type typically used for securing bone. In one embodiment, anchor 1105 is a screw inserted into the vertebrae of the vertebrae (see FIGS. 11A-11C, 11E 13A-13B and 14).

In one embodiment, as shown in FIGS. 12A-12D, the interconnecting means for coupling the base to the arm consists of a base head 1104. Base head 1104 may include a receptacle 1202 for receiving a receptacle end 112 of screw assembly arm 1103. In another embodiment, the base head 1104 is formed to hingeally attach one or more screw assembly arms 1103 using hinge means (see, eg, FIGS. 1A and 1B).

Base head 1104 may comprise fastening means. As shown in FIGS. 11A-11D and 12B-12D, the securing means may be a set screw 1107. The base head 1104 may be formed to include an open saddle (see FIGS. 11A and 11B) or a sealing feature (see FIGS. 11C-11E) to receive a locking means (eg, set screw 1107). In one embodiment, the securing means is a set screw 1107 that secures the base 1102 of the screw assembly 1101 together with the one or more arms 1103.

In use, screw assembly 1101 including base 1102, one or more arms 1103 and fastening means may be preassembled for transfer to the structure. Alternatively, screw assembly 1101 may be transported as separate parts that are assembled at some point in the structure.

As shown in FIGS. 11A, 11B, 11D, and 12B-12D, fastening the set screws 1107 allows one or more arms 1103 to be fixed in position relative to the base 1102. . In one embodiment, as shown in FIGS. 11D and 12B-12D, one or more arms 1103 of the screw assembly 1101 are moved from the first position parallel to the long axis of the base to the long axis of the base 1102. After being deployed to the second vertical position, the set screw 1107 is engaged to secure one or more arms 1103 to the second position. In yet another embodiment, a cam (not shown) may replace the set screw 1107.

In another embodiment, as shown in FIG. 11A, a single arm 1103 is connected to the base 1102 and the set screws 1107 can be fastened to secure the arm 1103 in position. In this embodiment, the arm 1103 may have a spherical receptacle end 1112 connected to the complementary receptacle 1202 of the base head 1104. Base head 1104 may be sealed or open (eg, the open saddle shown in FIG. 11A). When the set screw 1107 is fastened, a load for compressing the receiving end 1112 of the arm 1103 to the receiving part 1202 is generated to fix the arm 1103 to a predetermined position. As shown in FIG. 12C, the receptacle 1202 may be a spherical collet receptacle. In this embodiment, engagement of the set screw 1107 creates a load that compresses the receptacle end 1201 of the arm 1103 to the receptacle 1202 to receive one or more deformable fingers 1204. By deflecting around the minor end 1112, the arm 1103 is fixed in position (see FIG. 12C).

In another embodiment, as shown in Fig. 11B, two arms 1103 are connected to the base 1102, and the set screw 1107 is fastened to secure the two arms 1103 in position. Can be. In this embodiment, the first arm 1103 may include a spherical collet receptacle end 1201, and the second arm is configured to interconnect with the receptacle end 1201. It may include (see Fig. 12c and 12d). As shown in FIG. 12C, when the set screw 1107 is engaged, a load is generated that compresses the receiving end 1201 of the first arm 1103 to the receiving end 1112 of the second arm 1103. Thus, by deflecting one or more deformable fingers 1204 of the receptacle end 1201 around the receptacle end 1112 of the second arm 1103, the two arms 1103 are simultaneously fixed in position. .

The receptacle end 1201 of the first arm 1103 and the receptacle end 1112 of the second arm 1103 also allow each arm 1103 to be fixed step by step in a position relative to the base head 1104. It can be formed to be. For example, the accommodating end 1201 of the first arm generates a load that compresses the accommodating end 1112 to the base head accommodating part 1202 by initial tightening to freely rotate the second arm 1103. The first arm 1103 may be formed to be fixed at a predetermined position without affecting the movement. Upon final tightening, the receptacle end 1201 of the first arm 1103 is pressed against the receptacle end 1112 of the second arm 1103 by an increased load, thereby causing one or more deformations of the receptacle end 1201. Possible fingers 1204 are deflected around the receptacle end 1112 of the second arm 1103, allowing the second arm 1103 to be fixed in position.

In another embodiment, as shown in FIG. 11D, the set screw 1107 is received by generating a load that compresses the cylindrical receptacle end 1112 of the single arm 1103 to the complementary receptacle 1202. It can be fastened to fix the arm 1103 having the sub-end 1112.

In another embodiment, as shown in FIG. 12B, the set screws 1107 can be fastened to secure two arms 1103, where the first arm 1103 is end of the cylindrical collet receptacle. 1201, and the second arm 1103 (not shown) includes a receptacle end 1112 configured to interconnect within the collet receptacle end 1201. In this embodiment, upon fastening the set screw 1107, a load is generated which compresses the cylindrical collet receiving portion end 1201 of the first arm 1103 to the receiving portion 1202 (see FIG. 12B), By deflecting one or more deformable fingers 1204 (not shown) around the receptacle end 1112 of the second arm 1103, the two arms 1103 are fixed in position.

In a further embodiment, as shown in FIGS. 12C and 12D, the set screws 1107 may be fastened to secure two arms 1103, where the first arm 1103 is spherical collet shaped. A receptacle end 1201, and the second arm 1103 includes a receptacle end 1112 configured to interconnect within the collet receptacle end 1201. In this embodiment, upon engagement of the set screw 1107, a load is created that compresses the spherical collet receptacle end 1201 of the first arm 1103 to the receptacle 1202, thereby generating one or more deformable fingers. By deflecting 1204 around the receptacle end 1112 of the second arm 1103, the two arms 1103 are fixed in position (see FIG. 12C).

In another embodiment, as shown in FIGS. 11D, 12B, and 12D, the set screw 1107 includes a set screw opening 1115. The set screw opening 1115 can be formed to align with the longitudinal opening 1106 of the base 1102 such that a through path can be formed between the base 1102 and the longitudinal opening 1106 of the arm 1103. (Described above).

As shown in FIGS. 11A-11D and 13A-13B, one or more arms 1103 of the screw assembly 1101 may have an elongated body 1111 and a connector attached to the support structure 1109. An end 1108 and a receptacle end 1112. In one embodiment, the elongated body 1111 of arm 1103 is a rod. In yet another embodiment, the elongated body 1111 of arm 1103 is a rod that is split in the longitudinal direction. In another embodiment, the elongated body 1111 of arm 1103 is between two or more arms 1103 positioned at a first position (not shown) parallel to the long axis of base 1102. It is formed into a shape that can be interconnected. Such a shape may be, for example, the shape of a rod that is divided in the longitudinal direction.

In another embodiment, as shown in FIGS. 11C-11E and 13A-13B, the elongated body 1111 of the arm 1103 includes an offset section 1113. This excursion region 1113 may be formed to make the profile of the screw assembly 1101 small when one or more arms 1103 are positioned parallel to the long axis of the base 1102 (FIG. 11D and FIG. 11D). 12b). In addition, the deviation region 1113 may allow the body 1111 and the base 1102 of the arm 1103 to be linearly aligned when the arm 1103 is positioned parallel to the long axis of the base 1102 (FIG. 11D). And Figure 12b).

In another embodiment, as shown in FIGS. 11D, 12B, and 12D, the body 1111 of the arm 1103 includes a longitudinal opening 1106. In one embodiment, the longitudinal opening 1106 is a channel or groove (not shown) that extends along the length of the body 1111 of the arm 1103. In another embodiment, two interrelating arms 1103 may have a longitudinal opening 1106, which is a single longitudinal opening when the arms 1103 are operated in correlation. Aligned to form 1106. The longitudinal opening 1106 of the body 1111 of the arm 1103 may be coaxially aligned with the longitudinal opening 1106 of the base 1102 of the screw assembly 1101. The longitudinal opening 1106 extends over the length of the screw assembly 1101 and forms an opening through which the instrument, tool, and guide device (eg, K-wire) passes.

For example, as shown in FIGS. 11A-11B, the receptacle end 1112 of one or more arms 1103 may include hinge means for hinged connection with the base head 1104. In such embodiments, securing means may be provided to secure one or more arms 1103 to a position perpendicular to the long axis of base 1102 after deployment. Such fastening means may for example be a one-way ratchet (not shown).

In another embodiment, the receptacle end 1112 of the single arm 1103 may be formed into a cylindrical shape such that they are interconnected within the receptacle 1202 of the base head 1104. In this embodiment, the receptacle 1202 may be an opening to receive the receptacle end 1112 of the arm 1103.

In another embodiment, the receptacle ends 1112 of the two arms 1103 may be interconnected and disposed within the base head 1104. For example, the receptacle ends 1112 may be interconnected by collet shaped features. In the first embodiment, the two interconnecting receiver ends 1112 may be formed into a cylindrical collet shape, with a cylindrical groove, one or more relief cuts 1203 and one or more deformable fingers (1). A first collet receptacle end 1201 having a 1204 and a second rigid cylindrical receptacle end 1112 configured to be installed in a cylindrical groove (not shown) of the collet receptacle end 1201. do.

In a second example, as shown in Figs. 11A, 11B, 12C, and 12D, the two interconnecting receiver ends 1112 may be formed into a spherical collet shape, spherical grooves, one or more reliefs. First collet receptacle end 1201 having an incision 1203 and one or more deformable fingers 1204 and a second rigid spherical receptacle configured to be installed within the first collet receptacle end 1201. End 1112.

Also, as shown in FIGS. 12A and 12B showing a cylindrical collet shape, and FIGS. 12C and 12D showing a spherical collet shape, each receptacle end 1112 is connected to an interconnecting receptacle end 1112. May include a longitudinal opening 1106. This longitudinal opening 1106 may be formed to be coaxially aligned with the longitudinal opening 1106 of the base 1102 when the arm 1103 is positioned parallel to the long axis of the base 1102 (FIG. 12B and FIG. 12). 12d).

As shown in FIGS. 11A-11D, 13A, and 13B, the connector ends 1108 of one or more arms 1103 are formed to attach to the support structure 1109. As shown in FIGS. 13A and 13B, one or more support structures 1109 may be attached to the screw assembly 1101 to form the support assembly 1301. In one embodiment, each support structure 1109 consists of an anchor 1105, an opening 1110 and fastening means (see FIGS. 13A and 13B). One or more support structures 1109 can be made of materials that can be implanted into the human body and are durable, such as titanium, stainless steel, carbon fiber, and the like. In one embodiment, one or more support structures 1109 are made of titanium. In yet another embodiment, the one or more support structures 1109 are made of a biocompatible material, a resorbable material, or a combination of the aforementioned materials.

In one embodiment, each support structure 1109 is formed to attach to a patient's structure (eg, bone). As shown in FIGS. 13A and 13B, the fastening means for one or more support structures 1109 may be a set screw 1107. Alternatively, the securing means may be a cam (not shown).

As shown in FIG. 14, two support structures 1109 may be attached to the screw assembly 1101 and implanted into the lumen 1403 of the vertebrae 1401 and the vertebrae 1402 for support of the vertebrae 1401. It is possible to form a support assembly 1301. In yet another embodiment, a single support structure 1109 is attached to the screw assembly 1101 so that the support can be implanted into the lumen 1403 of the vertebrae 1401 and the vertebrae 1402 for support of the vertebrae 1401. It is possible to form the assembly 1301.

13A, 13B, and 14, a method of using the present invention to support the spine 1401 of the present invention comprises: 1) one or more arms 1103, base 1102 and interconnecting means (eg, one or more); Moving the screw assembly 1101 with the base head receptacle 1202 interconnected with the receptacle end 1112 of the arm 1103 to a bone, and 2) of the arm 1103 of the screw assembly 1101. Moving one or more support structures 1109 with fastening means and openings 1110 to the connector ends 1108 to a flanking bone, and 3) one or more arms 1103 of the screw assembly 1101. 4) securing one or more arms 1103 of the screw assembly 1101 to a predetermined position; and 5) securing the opening 1110 of the support structure 1109. Connecting the means. In one embodiment, the one or more positioning support structures 1109 may be transferred to bone, including, for example, one or more vertebrae where the screw assembly 1101 is transported to one or both sides. In another embodiment, the one or more positioning support structures 1109 are conveyed adjacent to the vertebrae to which the screw assembly 1101 is conveyed. In yet another embodiment, the one or more positioning support structures 1109 are transported to the distal end of the nearest vertebral body.

This spine support method can be used in conjunction with the percutaneous kyphoplasty method. Percutaneous vertebral balloon repair is a percutaneous procedure in which an inflatable structure, such as a balloon catheter, is used to form a cavity or cavity in the vertebra and then fill the cavity with bone substitutes to form an "internal casting". Bone substitutes include orthopedic procedures, including allograft or autograft tissue, hydroxyapatite, epoxy, PMMA bone cement or synthetic bone substitutes, medical plaster of Paris, or calcium phosphate or calcium sulfate cement Any suitable filler used at the time is mentioned. Methods and instruments suitable for such procedures are disclosed in more detail in US Pat. Nos. 4,969,888 and 5,108,404. Percutaneous percutaneous vertebrae balloon reconstruction can be used to reduce the vertebral compression fracture and to precisely move the bone to restore the preliminary fracture anatomy of the vertebrae as close to normal as possible. Spinal compression fractures caused by trauma (such as a car accident or drop) have typically been treated with open reduction internal fixation stabilization hardware and bonding techniques using a posterior approach. This stabilization hardware is used to remove the load on the fractured vertebrae and stop the movement across the intervertebral disc, allowing bone fusion to join one vertebrae to adjacent vertebrae and to maintain the stabilization hardware as a permanent implant. It becomes possible. In trauma, the stabilization hardware can be formed so that it can be easily removed after the bonding is made. Stabilization hardware can take many forms, including the forms described herein.

As described in pages 696-706 of Volume 13 (6) of the Spine, published by Wilsese and Spencer, published in 1988, the use of naturally occurring internal muscle surfaces The combination of implantation and percutaneous vertebral spinal balloon restoration can achieve the goal of improving the quality of patient care through minimally invasive surgical therapy.

The various preferred embodiments of the present invention have been described above. Nevertheless, it will be clearly understood that various modifications may be made to the present invention without departing from the spirit and scope of the invention. For example, although some embodiments describe the use of screws in securing to bone structures, the present invention is not so limited. Any fastening means can be used, for example cams, screws, staples, nails, pins or hooks. Accordingly, other other embodiments are included within the scope of the following claims.

Claims (43)

A screw assembly configured to support the structure, The screw assembly, A base formed to attach to the structure within the patient, Arm, Interconnecting means for coupling the base to the arm and allowing the arm to be positioned in a first position parallel to the long axis of the base and in a second position perpendicular to the long axis of the base Device comprising a. The apparatus of claim 1, wherein the arm is a support formed to receive one or more anchor assemblies and comprising a top and a bottom, wherein the anchor assembly includes means for securing the anchor assembly to the support. The apparatus of claim 1 wherein the base comprises a base head having a predetermined shape and securing means, and an anchor. The device of claim 3, wherein the anchor is selected from the group consisting of screws, staples, nails, hooks and pins. The apparatus of claim 2, wherein the support consists of a connector end, one or more openings, and a receptacle. 6. The apparatus of claim 5, wherein the connector end is formed to interconnect the base and the support of the screw assembly. 6. The apparatus of claim 5, wherein the connector end is formed to hingeally interconnect the base and the support of the screw assembly. 6. The apparatus of claim 5, wherein the at least one opening of the support comprises: a first connector end proximal opening sized to support a range of motion of the base relative to the support when assembled with the support, and means for securing the anchor assembly to the support; And at least one second connector end distal opening to allow access to the base. The apparatus of claim 1 wherein the support comprises a support member having a top and a bottom, a head assembly, and interconnecting means. 10. The apparatus of claim 9, wherein the support member consists of a receiving portion and one or more openings. The apparatus of claim 10, wherein the one or more openings comprise: a first opening through which the anchor assembly is penetrated and fixedly connected to the support member, and a second opening allowing access from an upper end of the support member for access to the head assembly; Device comprising a. 10. The connector assembly of claim 9, wherein the head assembly comprises: a connector end, an opening having a size supporting a range of motion of the base relative to the support, a connector end proximal opening having a size supporting a range of motion of the base relative to the support; And securing means for securing the head assembly to the support member, wherein the head assembly is configured to interconnect with the support member. The apparatus of claim 1, wherein the arm is formed to attach to the support structure. The device of claim 13, wherein the patient's structure is bone. The apparatus of claim 13, further comprising a support structure, wherein a screw assembly is attached by the arm to the support structure. The apparatus of claim 15 further comprising two screw assemblies, wherein the two screw assemblies are attached to the support structure. The apparatus of claim 13, wherein the screw assembly is sized such that its entire length is subcutaneously supporting the back of the spine. The apparatus of claim 13, wherein the arm comprises a body, a base yoke, and a connector end. 19. The apparatus of claim 18, wherein the body of the arm is rod shaped. The device of claim 13, wherein the base consists of a base head and an anchor. 21. The device of claim 20, wherein the anchor is selected from the group consisting of screws, staples, hooks and nails. The apparatus of claim 13, wherein the interconnecting means comprises a press-fit cross pin. The device of claim 13, wherein the interconnecting means consists of an open saddle head and a mating cross piece. 14. The apparatus of claim 13, further comprising a support structure comprising an anchor, a receptacle and a securing means, the anchor being configured to attach to the patient's structure, the receptacle having an opening attached to the arm of the screw assembly. And a receptacle, wherein the securing means is configured to secure the arm to the support structure after the support structure is deployed in the patient. The apparatus of claim 1, wherein the screw assembly comprises two or more arms. The device of claim 25, wherein the interconnecting means is selected from a list consisting of hinges, pins and collets. 27. The apparatus of claim 25, wherein the base consists of a base head and an anchor. The apparatus of claim 27 wherein said interconnecting means consists of a base head, said base head comprising a receptacle and a set screw. 29. The apparatus of claim 28, wherein the set screws secure the base to two or more arms of the screw assembly. 29. The device of claim 28, wherein by fastening the set screws, two or more arms are fixed in position relative to the base. The apparatus of claim 27 wherein said interconnecting means consists of a base head, said base head comprising a hinge means. 29. The end of claim 28 wherein the two or more arms comprise a body, the body having an elongated shape, the body having a connector end attached to the support structure and a receiving end connected to the base head receptacle of the interconnecting means. Device comprising a. 33. The apparatus of claim 32, wherein the elongate arm body comprises a deviation region, wherein the deviation region is configured to linearly align the base and the arm body when the arm is positioned substantially parallel to the long axis of the base. 33. The apparatus of claim 32, wherein the elongate arm body is shaped to fit fit between two or more arms positioned at a first position substantially parallel to the long axis of the base. 33. The apparatus of claim 32, wherein the receptacle end of the two or more arms and the receptacle of the base head comprise hinge means. 36. The apparatus of claim 35, wherein means are provided for securing the arm in a position substantially perpendicular to the long axis of the base. 37. The apparatus of claim 36, wherein the means provided to secure the arm is selected from the group consisting of one-way ratchets, setscrews and cams. 33. The apparatus of claim 32, wherein the screw assembly comprises two arms, the receiving ends of the two arms being formed to be interconnected. 39. The receiver of claim 38 wherein one of the receptacle ends of the two arms comprises a first collet shaped receptacle end having a substantially cylindrical groove, wherein the other receptacle end of the two arms is the first collet. And a substantially cylindrical shape interconnected with the mold receptacle. 37. The method of claim 36, wherein one of the receptacle ends of the two arms comprises a first collet receptacle end having a substantially spherical groove, wherein the other receptacle end of the two arms is the first collet. And a substantially spherical shape interconnected with the mold receiving portion. How to support bone structure, 1) moving a screw assembly comprising a support having a receptacle, a base, an interconnecting means and a securing means to the bone, 2) deploying the support substantially perpendicular to the long axis of the base, 3) implanting one or more anchor assemblies with base and securing means through the support into the bone; 4) securing the base within the one or more anchor assemblies; 5) securing one or more anchor assemblies within the support receptacle; 6) connecting the fixing means of the screw assembly to fix the position of the support relative to the base Bone structure support method comprising a. Spine support method, 1) moving the two screw assemblies with arms, base and interconnecting means to the bone, 2) moving the support structure in proximity to the bone, the support structure having two receptacles with securing means for the arms of the screw assembly; 3) deploying the arm of the screw assembly, 4) connecting the securing means of the receptacle to secure the arms of the screw assembly to the support structure Spinal support method comprising a. Spine support method, 1) moving the screw assembly with at least two arms, base and interconnecting means to the bone, 2) moving one or more support structures with anchoring means and openings for the arms of the screw assembly to the positioning bone, 3) deploying at least two arms of the screw assembly into the positioning support structure; 4) securing at least two arms of the screw assembly in a predetermined position, 5) connecting the fixing means of the support structure opening Spinal support method comprising a.

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