ES2350530T3 - BONE TREATMENT DEVICE. - Google Patents

Abstract

Bone treatment system comprising: A) an elongated body (300) configured for implantation within a bone and having a first and second ends defining a longitudinal axis of said elongated body (300), and a diameter ( 302) transverse with respect to said longitudinal axis; and B) a band (310) having a length substantially greater than its width or height, the band (310) being configured to establish contact and wind multiple times around said elongated body (300) between said first and second ends to increase the diameter (302) of said elongated body (300) when implanted within the bone; and wherein the winding of the band (310) around said elongated body (300) can be carried out manually or with the help of a mechanized tool, characterized in that said system further comprises a guide mechanism configured to control the position of the band (310) between the first and second ends of said elongated body (300) when said band (310) is wound around said elongated body (300).

Description

Field of the Invention The invention relates to a treatment system of bones defined in the preamble of claim 1. Background of the invention

Vertebral compression fractures, as shown in figure 1, represent a habitual wound of the spine and can result in a prolonged disability F. Margerl and others: A comprehensive classification of thoracic and lumbar injuries ("Summary classification of thoracic and lumbar wounds"), Eur Spine J 184-201, 1994. These fractures involve the collapse of one or several vertebral bodies or vertebrae

(12)

in the column vertebral (10) The fractures by

compression

from the column vertebral they have place

habitually

in the vertebrae lower from the column

thoracic spine or in the upper vertebrae of the lumbar spine. They generally behave fracture of the anterior part (18) of the affected vertebra

(12) (as opposed to the back side (16)). Fractures by vertebral compression can result in deformation of normal alignment or curvature by example, lordosis of the vertebral bodies in the area Affected spine. Fractures by

vertebral compression and / or vertebral deformities

related can result, for example, from diseases metastatic spine, trauma or can Associate with osteoporosis. Until recently, doctors they were limited in the way they could treat these compression fractures and related deformations. The pain medications, bed rest, supports or

surgery

vertebral invasive they were the unique options

available.

Plus

Recently, be have developed processes

minimally invasive surgical for the treatment of vertebral compression fractures. These procedures generally involve the use of a cannula or other access tool inserted in the part posterior of the affected vertebral body through the pedicles The most basic of these procedures is the vertebroplasty, which literally means the fixation of the vertebral body and that can be performed without repositioning First the bone.

Briefly, a special cannula or needle for bones is passed slowly through the tissues soft back. The x-ray image guide together with a small amount of an x-ray dye, It allows to appreciate the position of the needle at all times. A small amount of polymethylmethacrylate (PMMA) or other orthopedic cement is pushed by the needle inwards of the vertebral body. PMMA is a quality substance medical that has been used for many years in a series of orthopedic procedures. In general, cement is

mixed with an antibiotic to reduce the risk of

infection and a powdered material that contains barium or Tantalize it, which allows it to be appreciated in X-rays.

Vertebroplasty can be effective in reducing

or elimination of fracture pain, prevention of additional collapse and return to mobility in patients. Do not However, this procedure may not reposition the bone. fractured and therefore may not treat the problem of vertebral deformation due to fracture. In general, it is not carried out except in situations in which the

kyphosis

between bodies vertebral adjacent in he area

affected

is Minor of the 10 by hundred. Further, East

process

requires a injection from cement to high

pressure using a low viscosity cement and can lead to cement leaks in 30-80% of procedures, according to recent studies. Truumees, Comparing Kyphoplasty and Vertebroplasty, Advances in Osteoporotic Fracture Management (“Comparison of kyphoplasty and vertebroplasty, advances in osteoporosis fracture treatment ”), Vol. 1, No. 4, 2002. In most cases, cement leaks do not They cause damage. However, in some rare cases, the polymethylmethacrylate or other cement leaks into the vertebral canal or venous system perivertebral and causes pulmonary embolism, resulting in The death of the patient. J.S. Jang: Pulmonary Embolism of PMMA after Percutaneous Vertebroplasty, Spine Vol. 27, No. 19, 2002.

Other more advanced fracture treatments

Compression vertebrae generally involve two phases:

(1) replacement, increase or restoration of height original vertebral body and lordotic correction consequent of the curvature of the spine; and (2) filling or adding material to support or reinforce the fractured bone

Such a treatment, balloon kyphoplasty (Kyphon, Inc.) is shown in Figures 2A-D. Catheter which has an expandable balloon tip is inserted to through a cannula, sleeve or other type of introducer in a central part of a fractured vertebral body, comprising relatively soft porous bone surrounded by fractured cortical bone (figure 2A). Kyphoplasty get then the reconstruction of the lordosis or normal curvature due to balloon swelling, which expands inside the vertebral body restoring it to its height original (figure 2B). The ball is removed leaving a hole inside the vertebral body and then PMMA is injected u other loading material through the cannula inwards of the hole (figure 2C), as described in anterior with respect to vertebroplasty. The cannula is Withdrawal and cement cure to fill or fix the bone (figure 2D).

Among the disadvantages of this procedure are include the high cost, repositioning of the plates extremes of the vertebral body are lost after the removal of the balloon catheter and possible perforation of Extreme vertebral plates during the procedure. As in vertebroplasty, perhaps the complications

most feared, although they are remote, of kyphoplasty is

refer to leaking bone cement. For example, a neurological deficit may occur due to the leakage of bone cement into the vertebral canal. This cement leakage can take place by low veins resistance of the vertebral body or by a crack in the bone that has not been previously appreciated. Other Complications include: additional fractures adjacent to vertebral level, infection and cement embolization. The cement embolization takes place by a mechanism similar to cement leaks. Cement can be seen forced into a low venous system resistance moving to the lungs or brain, resulting in embolism or pulmonary infarction. Others details regarding balloon kyphoplasty can be find, for example, in US 6,423,083,

6,248,110 and 6,235,043 to Riley et al .; Gantis and others, Balloon kyphoplasty for the treatment of pathological vertebral compression fractures, Eur Spine J 14: 250-260, 2005; and Lieberman and others, Initial outcome and efficacy of Kyphoplasty in the treatment of painful osteoporotic vertebral compression fractures, Spine 26 (14): 1631-1638, 2001

Another system for the treatment of fractures by vertebral compression is the Optimesh system (Spineology, Inc., Stillwater, MN), which provides a very supply little invasive of a cement or allograft or autograft of bone using an expandable grid graft balloon

or retention device, inside the vertebral body

involved. The balloon graft belongs within the

vertebral body after swelling, which prevents intraoperative loss of replacement, as may occur during a kyphoplasty procedure when Remove the ball. A drawback of this system, no However, the grid implant does not fit integrated into the vertebral body. This can lead to a relative movement between the implant and the vertebral body and, as a consequence, a loss of replacement postoperative Other additional details regarding this procedure can be found, for example, in the US published patent application document nº20040073308.

Another additional procedure, used in the vertebral compression fracture treatment is a increasing mass of an inflatable polymer known as SKy Bone Expander. This device can be expanded up to pre-designed dimensions and configuration cubic or trapezoid in a controlled manner. Same as the ball Kyphon, once the height and the gap have been achieved optimal vertebrae, the SKy Bone Expander is removed and PMMA cement or other load is injected into the hole. This procedure therefore involves many of the same inconveniences and deficiencies that have been described previously with regard to kyphoplasty.

An improved procedure that has been proposed to reposition and increase compression fractures of a vertebral body is the so-called “stent” of vertebral body, for example, as described in Fürderer and others,

"Vertebral body stenting", Orthopäde 31: 356-361, 2002;

Published European Patent Application No. EP 1,308,134 A3 and Published US Patent Application No. 2003/0088249. The use of stents in bodies vertebral, as shown, for example, in the figure 3 generally involves insertion into a body spine of a catheter with a ball point (for example, same as a kyphoplasty balloon) surrounded by a stent (for example, such as those used in angioplasty). After the insertion of the balloon and the stent, the balloon is swollen using, for example, a pressure of a fluid thus expanding the stent inside the vertebral body After the expansion of the stent, the balloon can be deflated and removed, remaining the "Stent" inside the vertebral body in an expanded state to fill the vertebral body. It is known by the document WO2004 / 086934 A2 a very little invasive device, of according to the preamble of claim 1.

There is still a need for implants to reposition and increase fractured vertebral bodies and other bones

Characteristics of the invention.

The present invention solves these problems with a bone treatment system that presents the characteristics of claim 1. In one embodiment, The present invention discloses an implant for correction of vertebral fractures and other alterations of spinal column. For example, a cylindrical body or coil can be inserted into the damaged vertebral body

for a vertebral compression fracture. After the

coil insert, preferably rolled multiple times around the coil a wire, cable, thread or band, referred to in general in this description as "band." That band can have any profile or shape and can be formed by Any biocompatible material. During the winding, the diameter of the coil / band complex to which it is made reference in some cases as coil assembly rolled up, it can increase. This increase in diameter can create a push against the inside of the plates extremes of the vertebral body and reestablish the body vertebral at its original height. Additionally, fragments

or bone segments around the coil / band complex They can be compacted during the winding of the band.

In some embodiments, the features for control the rotation of the coil head and / or Band wrap may include a rod, rod or cannula to rotate the coil and a guide, guide conduit, cannula, tube to control and / or provide the band. The coil can have different configurations, multiple joints and / or can be curved.

In other embodiments, the little invasive implants for the treatment of spinal segments comprises an elongated body that has an end sized for implantation between a space between two or more vertebral expansions and a band associated with the body and configured to wrap around it to increase the diameter of the end and, thus,

increase the space between the two or more plates

extreme vertebrae, bone segments or bumps vertebral

In another embodiment, a device comprises several combinations of assemblies and components, according to the present invention For example, a set or team can comprise, for example, an insertion device, a coil and a band, in accordance with the present invention.

In another embodiment, a system for treating bones (filling, augmentation and / or bone replacement) preferably for very little osteopathic treatment invasive, you can understand a coil that has a certain diameter and a first and second ends, the coil configured for implantation within a bone and a band that is substantially longer in length than its width or height, the band being configured to make contact and roll around multiple times of the coil between the first and second ends to increase the diameter of the coil when it is implanted inside the bone. The system can understand also an elongated body that has a near end and a distal end, the near end being configured to user manipulation located outside the patient to place the distal end in a desired position within the bone and a joint arranged between the second end of the coil and the distal end of the elongated body. Coil It is cylindrical and comprises a hole through which a part of that band.

The elongated body may comprise at least one

part of a drive cable assembly to rotate the

coil when it is implanted inside the bone. He elongated body is set to rotate and the joint is set to transfer rotation from the body

elongate

for do turn the coil. The Union is

removable,

from way that he body elongate may be

removed from the coil.

The system may further comprise a set of drive cable configured for fixing removable and perform the rotation of the coil having a near end and a distal end, the near end in its use to extend from the patient and be manipulated by the user to place the distal end in the desired position in the bone, the distal end being connected so detachable to the coil. The cable set of drive is rotatable to force the coil to rotate when it is located in the bone. The guiding mechanism may comprise a displaced guide with respect to the coil to control the position of the band between the first and second ends when the band is rolled Around the coil.

The drive cable assembly may comprise a rotary axis and the guide mechanism may comprise a elongated tube coaxial with the rotating shaft. Elongated tube it is movable in axial direction with respect to the coil and establishing contact with the band to position the same between the first and second ends of the coil.

The system can also comprise a connected button to the elongated tube and containing a guide hole for the band.

The coil may have thread steaks to help the Guided band.

In an alternative, the drive assembly can comprise a rotating shaft that has a near end and a distal end, so that the distal end of the shaft can be detachably and rotatably connected to First end of the coil. The axis is capable of transmitting a torque to the coil. The guiding mechanism of the alternative may comprise a guide tube that has a proximal end and a distal end through which it travels the band, the guide tube being axially movable with with respect to the shaft or rod.

The rotating shaft and the guide tube may be located on a needle, so that the rotating shaft is axially fixed with respect to the needle and guide tube it moves axially with respect to the needle. A part of the needle can be arranged along the bobbin and adjacent to it.

The system can also comprise a set impeller to convert the rotational movement of the drive device in axial motion, the drive assembly connectable to the drive device and to the guide tube to move the guide tube axially. The drive assembly may comprise a gear train connectable with the rotary drive assembly, a disc of

rotary cam and axially movable cam follower

But not rotating. The cam disc that has a groove to along its outer surface and the follower comprises a projection, so that this projection extends towards Inside the slot

The follower can be a reel holder and the an outgoing pin insertable through a hole in The reel holder.

The band may be coated with a matrix with other materials or may be part of it, including osteoinductive materials, osteoconductors, antibiotics, tricalcium phosphate, morphogenetic proteins of the bone

In another embodiment, a system for treating bones with minimal invasion, filling, augmentation and / or replacement of bones can comprise an elongated body that has a first end and a second end, the body possessing a section along its longitudinal axis configured to implantation within a bone and a device insertion to insert the elongated body into a bone, the insertion device comprising a band and being configured to make the band roll multiple times around the elongated body between the first and second ends to increase the diameter of the body and band assembly, being the device of insert can be detachably connected to the body. He insertion device may comprise a device of drive to apply a rotational force to the body elongated to make the elongated body rotate around

of its longitudinal axis to wrap the band around the

body

elongate, for increase he diameter of the

body

elongated and set

from the band implanted inside from the

bone area

The system may further comprise a mechanism of axial guide axially movable with respect to the body elongated, the axial guide mechanism in connection with the position of the band and controlling it, along the stretch of the elongated body during its turn.

The drive device may comprise a rod connected to the elongated body, said rod being rotary, which in turn causes the body to turn elongate. The guide mechanism may comprise a cannula external that causes the band to be positioned along of the stretch of the elongated body. The continued rotation of the elongated body causes the diameter of said body elongated and band set increase due to winding of the band around the elongated body.

In an alternative, the drive device can comprise a drive mechanism, a drive shaft and a flexible shaft connected in series to the elongated body and the guide mechanism may comprise a guide conduit of the band, a reel stand and a cam disc rotary. The cam disc and the reel holder converts the rotational force of the cam disc into a oscillating force applied to the band guide conduit, causing the band guide conduit to move forward and backward with respect to the body elongate. The band guide duct can

it comprises an inner passage that has a proximal opening and

a distal opening and in which the band is arranged moving through the inner passage of the guide duct of the band out of the distal end where it is rolled around said body.

The insertion device may further comprise a drive assembly to couple the drive shaft of the drive device to the cam disc of the mechanism guide in order to make the cam disc rotate at a speed other than the drive shaft, so that the drive assembly comprises a gear train of drive, a pinion and another wheel.

In another embodiment, a system for treating bones with minimal invasion for filling, augmentation and / or bone repositioning can comprise a body elongated having a first end and a second end. The body that has a certain length, according to its axis longitudinal, is configured for implantation within a bone. The system can also comprise a device of insertion destined to insert the elongated body inside of a bone The insertion device may comprise a band and be configured to cause the band to wind multiple times around the elongated body between the first and second ends to increase the diameter of the body and band assembly, the device being

insertion

connectable from shape removable to the body. He

device

from insertion may understand also a

device

from impulsion for Apply a force from

rotation

to the body elongate for do that he body

elongate rotate around its longitudinal axis to

wrap the band around the elongated body for the purpose to increase the diameter of the elongated body assembly and the band implanted within the bone area. He drive device may comprise a mechanism of drive, a drive shaft and a connected flexible shaft in series to the first end of the elongated body. He insertion device may further include a mechanism axial guide movable axially with respect to the body elongate. The axial guide mechanism is in connection with the band and controls its position along the length of the elongated body during its rotation. He guide mechanism may comprise a guide conduit of the band, a reel stand and a cam disc rotary, so that the cam disc has a groove to along its outer surface and the reel holder includes a projection, so that the projection extends into the cam disc slot. The device of insertion can also comprise a drive assembly which couples the drive shaft of the drive device to the cam disc of the guide mechanism for the purpose of making that the cam disc rotates at a different speed than the axis of drive. The drive assembly may comprise a train of gears, a pinion and another wheel. The cam disc and the Reel stand convert the rotational force of the cam disc in an oscillating force applied to the duct of guide of the band causing that the conduit of guide of the band moves forward and backward with with respect to the elongated body and comprising the conduit of

band guide an underpass that has an opening

proximal and a distal opening and in which the band is arranged in the underpass of the guide duct of the band and moves through it, out of the end distal, where it is wrapped around the body. The axis flexible and the band guide duct are located on a needle, so that the flexible shaft is fixed axially with respect to the needle and the guide duct of the band moves axially with respect to the needle. A part of the needle is arranged along the coil and adjacent to it and the continuous rotation of the elongated body causes the diameter of the whole of the elongated body and band increase due to winding of the band around the elongated body.

Brief description of the drawings

The invention will be explained in greater detail and you will understand better through the following drawings that they have an example character, so that the numerals of Equal references represent equal elements. The drawings are merely exemplary to illustrate some features that can be used in a way exclusive or in combination with other features and the The present invention should not be limited to Realizations shown.

Figure 1 is a representation of a fragment of spine that has a compression fracture vertical in a vertebral body;

Figures 2A-D are representations of a method of prior art for the treatment of a fracture by

vertical compression;

Figures 3A and B are side views of an apparatus of coil and band, according to an embodiment of the present invention;

Figures 4A and B are side views in section of an apparatus for osteopathic treatment with minimal invasion of a vertebral body, according to an embodiment of the present invention;

Figures 5A and B are side views in section of another embodiment of an apparatus, in accordance with the present invention;

Figures 6A and B are side views in section of another embodiment of an apparatus, according to the present invention;

Figures 7A and B are sectional views of an apparatus which uses a band guide, according to a embodiment of the present invention;

Figure 8 is a detailed sectional side view of the apparatus of Figure 7A and B;

Figure 9 is a sectional top view of another embodiment of an apparatus, according to the present invention;

Figure 10 is a representation of an embodiment of a device and insertion coil, according to the present invention;

Figure 11 is a representation of another embodiment of an insertion and coil device, according to the present invention;

Figure 12 is a sectional view of the device insert and coil shown in figure 11;

Figure 13 shows a sectional view of the insert and coil device of figure 11 showing the use of small band reels;

Figures 14A and B are sectional views of the body. housing of the insertion device shown in the figure 11;

Figures 15A and B are a view from one end and side view of the end cap of the device insertion shown in figure 11;

Figure 16 is a sectional view of the pinion of the insertion device shown in figure 11;

Figures 17A and B are sectional views of the axis of drive of the insertion device shown in the figure 11;

Figure 18 is a sectional view of the cam disc of the insertion device shown in Figure 11;

Figure 19A is a side view of the support of reel of the insertion device shown in the figure eleven;

Figure 19B is a section of the reel holder of the insertion device shown in Figure 11;

Figure 20A is a sectional top view of a large band reel, according to the present invention;

Figure 20B is a perspective view of a large band reel, according to the present invention;

Figure 21A is a sectional view of a reel of small band, according to the present invention;

Figure 21B is a perspective view of a

small band reel, according to the present invention;

Figures 22A and B are side views in section of an embodiment of a needle, according to the present invention;

Figures 23A and B are a sectional view and a extreme view, respectively, of an embodiment of a needle, according to the present invention;

Figures 24A-C are, respectively, a view. lateral section and a view from one end of a embodiment of a needle of the present invention;

Figure 25 is a sectional view of a conduit of band guide of the present invention;

Figure 26 is a sectional view of an axis flexible of the present invention;

Figures 27A-C are side views in section and in detail, as well as a view from one end, respectively, of a coil of the present invention;

Figure 28 is a sectional top view of another realization of an insertion tool and a coil of the present invention, showing three bands;

Figure 29 is a sectional view of the device

from

the Present invention showing he axis flexible with

four unions;

The

figure 30 is a view in section of the Present

device showing the flexible shaft with two joints;

Figures 31A and B are, respectively, a view in section and an end view of another embodiment of an expandable osteopathic augmentation apparatus, according with an embodiment of the present invention;

Figure 32 is a sectional top view of a flexible coil, according to an embodiment of the

present invention;

The

figures 33A-C They are representations that show

different

configurations from coils, from agreement with

embodiments of the present invention;

Figures 34A and B are sectional views of a expandable osteopathic augmentation apparatus that is used in next position in a femur, according to an embodiment of the present invention

Detailed description

A vertebral body can be filled, augmented or repositioned by insertion of one or more implants in an internal part of the vertebral body, between the plates extremes of two adjacent vertebral bodies, or in others bones, for example, a femur. In one embodiment, a implant for vertebral body can comprise a coil with wire, cable or wire, to which reference will be made together as a band (310), wrapped around the coil to create a mass or body of greater diameter, at which will be referred to in some cases as a whole winding, winding band assembly, winding body, final implant or simply implant. The coil with the coupled band can be inserted into the vertebral body to through, for example, transpedicular access channels which have an approximate diameter of 5 mm.

Referring to Figure 3A, an element elongated (300) that can be cylindrical and to which it will be made

reference below as coil (300), has a

certain diameter (d1) (302). After insertion of the coil (300) in a collapsed vertebral body, the band

(310) is wrapped around the coil (300) to create a larger coil / band mass (312) at which it is made reference also as final implant (312) as it has been shown in figure 3B. This roll can be carried carried out by rotation of the coil (300), by movement of the band (310) around the coil (300) or by any combination of them. The band (310) may have different shapes and different dimensions and can be made of Any biocompatible and perfectly flexible material. The length of the band may be substantially greater than its width or height You can use one or several specific band shapes to create any desired configuration of the band set of coil depending on the desired application. The band (310) It can be formed by different materials, such as nylon, polymers, metals and the like. The band (310) can be radiopaque, such as suture material, metal, metal with bone cement coating, metal with a bone cement surface, metal with a surface of a polymer to allow coil welding and the surrounding tissues together to reduce the bone micromovements after augmentation and fibers natural, including a metal wire. The band can be woven, twisted, solid, tubular or any other known type. The band should preferably be able to resist tensile stress, preferably higher

at 100 N and preferably resist transverse stresses

No significant deformation. The band must be able, also, preferably, of sliding along the tissues within the vertebral body, but not along the coil The band (310) can be wound with a matrix or be part of it with other materials, such as osteoinductive materials, materials osteoconductive, antibiotics, bone cement, bone chips, hypoxiapitate, tricalcium phosphate, bone morphogenic proteins (BMG), etc. For strictures of the spine, the band may be coated preferably with a material that inhibits the fusion of bones, while in the application between end plates vertebral, the band, as a fusion device between vertebral bodies, can preferably promote the growth and bone integration.

The heating mechanisms for the fusion of band coating may consist of ultrasound or an electric current, although they are expected other methods for the fusion of the coating of the band.

During

he winding he diameter (302) of the

set

(312) from the band rolled up increases until a

dimension

desired (d2). Further, he diameter (302) of the

implant may vary along the length of the coil to adapt the dimensions and shape of the implant. Referring to figures 4A and 4B, the coil

(300) is inserted into the central part (400) of the body vertebral (12), for example, through a cannula or Another introducer The appropriate procedures and materials

used to insert a cannula through which it

you can enter the coil (300) are known in this technique and may be similar to those described formerly for kyphoplasty and other procedures. By example, the coil (300) can be introduced through the back (20) of the vertebral body (12). After that the coil (300) has been inserted, a band (310) can be wrapped around the coil (300) to form the rolled band assembly (312). By increasing the diameter (302) of the coil (300), the end plates (402, 404) of the vertebral body (12) can be separated each other and the vertebral body can be restored to its original height (figures 4A and 4B). Additionally, the coil (300) around the bone can be compacted during the winding of the thread or band (310).

In some embodiments, the coil may comprise one or more joints to provide the surgeon with possibility of inserting and / or arranging the coil according to

any angle α or with another orientation. Figure 5A shows a coil with a joint (514) before body augmentation (12) and Figure 5B shows a coil with a joint (514) after augmentation. The band (310) can pass through the passage (522) of the axis (520) of the coil (500) before its winding in the wound band assembly (512).

Figures 6A and B show the use of a coil (600) that has two unions (614, 616) for the positioning and orientation of the coil (600) inside the vertebral body (12). Figure 6A shows the coil articulated (600) before magnification and figure 6B shows enlarged coil implants (312) after

winding of the band (310) around the coil

(600) inside the vertebral body (12). In some embodiments, as shown in Figures 5 and 6, the band (310) can be inserted through a step center or lumen on the shaft (520, 620) of the coil (500, 600), respectively.

Referring to Figures 7A and 7B, the band winding (310) can be facilitated using a guide (700), to which reference is made also as a slide (700). For example, as it has been shown in figure 7A, the coil (500) having the Slider (700) can be inserted inside the body vertebral (12) through a cannula (710). Coil

(500) may have a joint (514) that allows the articulation of the end (512) of the coil (500) with with respect to the axis (520). The slide (700) can move uniformly or predefined or manually User controlled, with respect to the coil (500) to guide the winding of the band (310) on the coil to expand implant dimensions (512) and Define your shape.

As shown in Figure 7B, the guide (700) is you can incorporate with a coil set that has two or more unions, for example, the coil (600) with two unions. The coil (600) can be inserted into a vertebral body

(12) through the cannula (710) and the band (310) can pass through the shaft (620) of the coil (600). The band

(310) is coupled with the slide (700) that cooperates with the

coil (600) to guide the band (310) around the

coil (600) and increase the dimensions of the coil (612). The unions (614) and (616) allow the articulation of the coil (600) to a desired position and orientation for the vertebral body augmentation (12).

In certain embodiments, the head (602) of the coil

(600) and / or the coil (612) remain in the vertebral body

(12) after the cannula (710) and the shaft (620) of the coil have been disassembled from the patient to increase the vertebra and maintain an appropriate lordosis. In others embodiments PMMA or other cement or load is inserted inside of the vertebral body (12) along the coil of bearing (612) to further increase the fixation or Repair of the damaged area. In other embodiments, the coil (600) and / or the winding coil (612) are removable after bone repositioning and injects PMMA or other filler material into the hole created by the coil (612).

Figure 8 is a sectional and detailed view of a coil, for example, the coil (500), which has a guide or slide (700) to facilitate winding of the band (310). As described above, the coil (500) can be inserted through the cannula

(710) and may include one or more joints (514) for facilitate the positioning of the coil (512). The slide

(700) may include a head (703) that manipulates the band

(310) and cooperates with the coil (500) to control the band winding (310) to enlarge the coil (512). The slide (700) can use a screw or another

mechanism to provide a uniform winding or a

certain model of winding and / or the slide can be configured to be manipulated by the user to Provide any desired model and shape of coil winding (512), for example, to optimize the coil coupling (512) with internal walls of the vertebral body (12). The slide (700) can swing, bend or slide or make a combination of these movements to facilitate the placement of the band (310) around the coil (500). The slide

(700) can pass through the cannula (710) out of the coil, as shown in figure 8. In others embodiments, the slide (700) can be coupled and / or go through the shaft (520) of the coil (500), it can be fixed to the cannula (710) or can be introduced into the vertebrae to through another cannula or introducer.

The band (310) can pass through the cannula (710), such as shown in figure 8. In other embodiments, the band (310) can pass through the axis of the coil (520). In other embodiments, the band (310) can be inserted by a different cannula than the cannula through which it was inserted the coil For example, as shown in the Figure 9, the coil (600) having two unions (614) and

(616) and the slide (700) can be inserted into the body vertebral (12) going through a first cannula (710), while the thread (310) can be inserted into the body vertebral (12) going through a second cannula (900).

Figure 10 shows, in more detail, several components of an embodiment of a coil (800) fixed to

an insertion device (810). In this embodiment, the

band (310) can be wrapped around a coil (800) due to the rotation forces created by a device of drive (840) of the insertion device (810). He drive device (840) of the device (810) is composed of a drive mechanism (814) and a rod (825). In addition, a manual axial force applied to a axial control assembly (830), in this embodiment that it comprises an external cannula (811) and a button (813) of the insertion device, position the band (310) at length of the axial axis of the coil (800). Controlling the drive device (840) and control assembly axial (830), the user can create different shapes, such as a conical shape or "egg" shape, of coil band assembly (812).

The axial control assembly (830), for example, the external cannula (811) and button (813), can guide the drive device (rod (812) and mechanism drive (814)) and the coil (800) into the body vertebral and also move the band (310) axially on the coil (800). Button (813) can be set to an intermediate section of the outer cannula (811) so fixed, such that the ends (817, 818) of the outer cannula

(811) protrude beyond the button (813). The button (813) it can have an opening (815) through which the band (310) through mode. The button (813) can be cylindrical shape, as shown, or may have other forms. The button (813) can be made based on Different materials, such as metal, plastic and rubber.

The outer cannula (811) has an internal diameter that is

greater than the outer diameter of the rod (825), which is can be inserted through the external cannula (811). He distal end of the outer cannula (811) has the coupling (816) that helps guide the band (310) over the coil (800). The coupling (816) is located preferably fixed to the outer cannula (811), but it can also be moved, for example, moved or rotated with respect to the outer cannula (811). The coupling (816), together with the manual axial force applied to the external cannula (811), controls the position of the band

(310) on the coil (800). Shifting the coupling

(816) axially backward and forward is achieved the band (310) moves forward or backward on the coil (800). The band (310) is rolled around the coil (800) below the coupling (816). The coupling (816) limits the diameter of the mass

from

the band around  from the coil (800). Yes good he

coupling

(816) be he has shown with a curvature,

preferably

with a radio, other shapes They are too

possible for coupling (816). The shape of coupling (816) can influence and limit the final shape of the rolled band assembly (812). While it has been described an axial control assembly comprising multiple pieces, you can also comprise a single piece and is not limited to the form shown.

The drive device assembly (840) of the insertion device (810) may be formed by the rod (825) and the drive mechanism (814). The rod

(825) has a proximal end (819) and a distal end

(820). At the near end (819), the rod (825) has preferably a coupling interface (822) that is compatible with the docking interface (821) of the drive mechanism (814). An example of an interface of coupling could be a ball stop mechanism, such like those that exist in the drive devices of ratchet, a bayonet nut connector, thread, conical connections or a hexagonal connector. I also know can use corresponding male and female connectors Hexagonal, star or otherwise. They are anticipated Other forms of coupling for the interface. The extreme distal (820) of the rod (825) has another interface of coupling (823) that is compatible with the interface of coupling (824) of the coil (800) for coupling preferably detachably the coil (800) to the rod (825). The drive mechanism (814) rotates the rod (825) around its longitudinal axis. He drive mechanism (814) can be driven by hand, such as, for example, a T-shaped handle, as it has been shown in figure 10 or mechanical, such as a drill a engine (not shown). The operation of the mechanism of drive (814) causes the rod (825) to rotate and the rod (825) causes the coil to rotate (800). From alternatively, the drive mechanism (814) can be integrated with the rod (825) or the mechanism of drive can preferably be connected so Detachable directly with the coil (800), so that the rotation of the drive mechanism rotates the

coil.

The coil (800) may comprise a cylindrical shaft that It has its threaded exterior and whose external diameter is smaller than the inner diameter of the outer cannula (811). He Threaded outer can assist in guiding the band of winding (310) around the coil (800). Coil

(800) is fixed to one end, the distal end of the rod (825) and is inserted through the other cannula

(811) so that the coil (800) protrudes from the distal end of the outer cannula (811). The coil (800) it can also comprise a hole (801) that crosses the cylindrical shaft, so that one end of the band (310) can be fed through the hole (801) to coupling and retention, preferably, of band (310) in place on the coil (800). Other fixing means from the band (810) to the coil (800) can also be used

The operation of the insertion device (810) and the coil (800) to create a final implant is not will explain. The coil (800) that has a band (310) inserted in the hole (801) of the cylindrical shaft is coupled to the rod (825). The insertion device

(810) comprising the whole device of drive (840) and axial control assembly (830) with the coupled coil (800) can be introduced into a body collapsed vertebral (not shown). The device of insert (810) is preferably inserted by a cannula, but can also be inserted using a open or percutaneous incision when drilling the skin

and soft tissues with the coil (800) arranged in the

vertebrae The drive mechanism (814), connected to the rod (825), rotate the rod (825) so that the band

(310) is wrapped around the coil (800) to create a larger mass of coil / band, what is done reference also as final implant. The user can move the outer cannula (811) forward and towards back with respect to the collapsed vertebral body, to allow the band (310) to wrap around the entire axial length of the coil (800). Also, displacing the external cannula (811) forward and backward It allows the user to create different forms of larger coil band set. During the winding, the diameter of the rolled band assembly Increase to desired dimensions. The coupling

(816) in the outer cannula (811) helps create different shapes of the band set rolled over large and also to limit the diameter of the whole of the rolled band. The implant diameter can be varied to along the length of the coil (800) to adapt the Implant dimensions and shape. Once the desired dimensions and shape of the band set rolled have been achieved, the user cuts the band (310). This can take place outside the vertebral body. After the band (310) has been cut, the user rotates the rod (825) and the coil (800) using the drive mechanism (814) to wind the end of the band around the coil (800), so that the band

(310) is completely wrapped around the coil

(800) inside the vertebral body. Once it has

achieved, the user pulls the rod (825) and the drive mechanism (814) causing the rod (825) undock the coil (800), leaving the coil (800) in the vertebral body The rod (825) can then be complete withdrawal of the patient. In addition, the cannula external (811) is also disassembled after the rod (825) and coil (800) have been disassembled. Be You can insert PMMA or other cement or load into the body vertebral that contains the mass of coil / band for further increase the fixation or repair of the area damaged.

Another embodiment of a coil implant is the shown in figures 11-30. Figure 11 shows a coil (1160) with an insertion device (1000). From similar to the previous embodiment, the coil (1160) it is forced to rotate around its longitudinal axis and a

or several bands (310) are wound around the axis of the coil (1160) to create a set of rolled band larger. The insertion device (1000) transfers the rotation movement of a drive mechanism (not shown) to force the coil to rotate (1160). When effect the winding of a single band (310), the insertion device (1000) also displaces preferably the band (310) axially along the axis of the coil (1160). Meanwhile, when the multi-band winding (310) around the coil (1160), no movement may be necessary axial. When multiple multiple bands (310) are rolled

around the coil (1160), the bands (310) are wound

preferably around the coil (1160) in different places along the axis of said coil (1160). In a single band configuration, the insertion device (1000) preferably works by spinning the coil (1160) around its longitudinal axis and also providing axial movement of the band (310) with respect to the coil (1160). Coil rotation (1160) is achieved by a device set of drive (1300) comprising a drive shaft (1110), a flexible shaft (1070) and preferably a mechanism of rotary drive (not shown). While the whole of drive device (1300) has been shown and has been described comprising multiple pieces may consist of a single component or may comprise other components other than those shown and described. Axial movement

from

the band (310) with respect to the coil (1160) is

got

through he mechanism from guide (1600) that

understands

a conduit (1120) from guide from the band, a

Reel holder (1030) and a cam disc (1010). Yes well the guide mechanism (1600) has been shown and described comprising multiple pieces, you can also comprise a single component or additional components other than shown and described. In addition, although the device insertion (1000) axially fixes the location of the coil (1160) and axially displaces the band (310) at length of the axial length of the coil (1160), the position of the band (310) could be fixed and the coil (1160) could shift axially.

Referring to the device set of drive (1300), the drive shaft (1110) is generally cylindrical in shape and can have a length of about 115 mm, although other lengths are expected. A section (1116) of the drive shaft (1110), near the near end (1111) can have a jagged around the circumference of the drive shaft (1110). The extreme proximate (1111) of the drive shaft (1110) extends from the near end (1023) of a wrapping body (1020) of the insertion device (1000). As it has been shown in Figures 17A and B, the near end (1111)

of the

axis from drive (1110) have a characteristic from

coupling

Quick (1114) that is compatible with a

mechanism

from drive preferably a  mechanism from

rotary drive that provides torque to drive the shaft (1110), such as, for example, a T-shaped handle

or drill (not shown). A lock washer (1230) and a stopper disk (1170) are coupled near the end projection (1111) of the drive shaft (1110) (figure 12) preventing the drive shaft (1110) from moving in distal direction Lock washer (1230) and disk stop (1170) can set stop with a cap end (1100) (figures 15A and B) coupled to the end near (1023) of the enveloping body (1020). The hood end (1100) is fixed to the enclosure (1020) by medium of shear-resistant pins (1260), preferably three shear resistant pins (1260). Other means can be used to fix the

extreme cap (1100) to the enclosure body (1020). The axis

discharge (1110) protrudes through the central hole (1102) on the end surface (1104) of the hood extreme (1100). The distal end (1112) of the axis of drive (1110) extends into the body envelope (1020) and has a docking interface (1113) that can be compatible with an interface of coupling (1075) at a proximal end (1074) of the shaft flexible (1070). An example of a docking interface it could be a ball stop mechanism, such as those are found in the drive devices of ratchet, a bayonet turkish connector, thread or conical connections. Another example of an interface of coupling could be a hexagonal projection or another form housed in a recess correspondingly hexagonal or other. The drive shaft (1110) is connect to the flexible shaft (1070) inside the body envelope (1020).

The flexible shaft (1070) (figure 26), connected to the shaft drive (1110) with coupling intermediate (1075) at its near end (1074) it extends into a needle (1040). The flexible shaft (1070) can comprise preferably two components, a rigid rod optionally straight (1071) and a flexible component (1072) distal with respect to the rigid rod (1071). The extreme distal (1073) of the flexible shaft (1070) is connected to the coil (1160) preferably by means of a coupling of quick disconnect (1076). Disconnection coupling fast (1076) can take any of several forms,

such as a ball stop mechanism, such as those

They are in type drive devices ratchet, a bayonet nut collector, thread, conical connections, hexagonal connections, etc. He coupling (1076) also allows the flexible shaft (1070) is disconnected from the coil (1160) when the user performs a pulling action on the axis of drive (1110) together with the flexible shaft (1070) in a next direction along the longitudinal axis of the enclosure (1020) and drive shaft (1110). A drive mechanism spins the drive shaft (1110) which in turn rotates the flexible shaft (1070) that spins the coil (1160). Flexible shaft (1070) rotates inside the main hole (1042) formed in the needle (1040).

The needle (1040) helps in the insertion of the coil inside the vertebral body similar to the cannula external (811) of the previous embodiment. The needle (1040) (Figures 22-24) is preferably attached to the end distal (1026) of the envelope body (1020) and extends from it. The needle (1040), in particular the configuration of the distal end (1041) of the needle (1040), can take different structures and forms, some of which have been shown in figures 22-24. The needle (1040) has a general cylindrical shape with a shape semi-cylindrical at its distal end (1041). The needle (1040) it can have an approximate length of 126 mm with a external diameter of about 5 mm, although this length and this diameter are for example only and are intended

other lengths and diameters. The distal end (1041)

it can have an open, flat surface (1047) on the resting the coil (1160). Alternatively, the flat surface (1047) can be tilted so that the distal end (1041) has a larger dimension, causing the flexible shaft (1070) to be bent or flexed (figure 23A). A threaded pin (1270) through of the hole (1022) at the distal end (1026) of the body envelope (1020) retains the needle (1040) in the body envelope Other means of fixing the needle (1040) to an enveloping body.

The coil (1160) (figures 27A-C) can be cylindrical with an approximate length of 16 mm and a diameter approximately 2.5 mm, although this length and diameter It is merely an example and can be foreseen other lengths and diameters that will depend in part on the desired final shape of the implant. The coil (1160) can have a rough surface that provides friction to the surrounding band to facilitate transfer of force between the rotating coil (1160) and the band rolled (310). The proximal end (1061) comprises a quick disconnect coupling (1062) that complements the coupling (1076) on the flexible shaft (1070). He Distal end (1163) of the coil (1160) can be hollow. At the end located in the most distal zone of the coil (1160), a hole (1164) may extend according to the coil diameter (1160). Two can be included additional holes (1165, 1166). These holes are extend only on one side of the circumference

external coil (1160). The holes (1164, 1165 and

1166) can assist in the coupling of the band (310) to the coil (1160). With the band (310) fixed to the coil (1160), the rotation of the coil (1160) will cause the band (310) is wound around said coil (1160). He rotational movement of the coil (310) performs traction on the band (310) from the reels of the band (1140, 1150) located inside the enclosure (1020). The cone shape around the coil (1160) in the figures 11 and 12 shows a form, by way of example, that can form the coil wound when implanted in a vertebra.

The axial movement of the band (310) with respect to the coil (1160) is achieved by a mechanism of guide (1600) comprising the band guide conduit (1120) (figure 25), the reel holder (1030), the disc cam (1010) and the gear train (1700). At insertion device (1000), the rotational movement of the drive mechanism becomes axial movement that it is transmitted to the conductor (1120) of the band guide to control the axial location in which the band

(310) is wound on the coil (1160). The train of gears (1700) can comprise the gear of drive (1080) and the pinion (1130) on which it is wheel mounted (1090). The gear train (1700) works by transferring the rotational force of the axis of drive (1110) to cam disc (1010), so that the cam disc (1010) can rotate at a speed other than that of the drive shaft (1110), for example, the disk of

cam (1010) can preferably rotate once every five

rotations of the drive shaft (1110). Cam disk (1010) converts the rotational force of the drive shaft (1110) in an axial force, preferably oscillating, intended to cause the reel holder (1030) to move axially, preferably swinging towards forward and backward. The support (1030) of the reel moves the conduit (1120) of the band guide so similar in axial direction, preferably in a oscillating movement back and forth. He objective of an axial movement is to make the band (310) moves axially, relative to the coil (1160).

More specifically, the train teeth of gears (1080) gear with the teeth (1116) of the shaft of drive (1110) and with the teeth of the wheel (1090), which revolves around the pinion (1130). The teeth of the wheel (1090) also engage with teeth (1016) located at the near end (1017) of the cam disc (1010). That is, the gear train (1080) interacts both with the drive shaft (1110) (figures 17A and B) and with the wheel (1090), causing the cam disc (1010) turn at a different speed, preferably at a slower speed, than the drive shaft (1110). The wheel (1090) is arranged on the pinion (1130) (figure 16) which is held in position by the washer lock (1240). The gear train (1700) can be set to cause the cam to work at desired speed to control axial movement and

depending on the gear train, the cam disc (1010)

can rotate faster or slower than the axis of drive (1110).

The cam disc (1010) (figure 18) is cylindrical in its shape and has an approximate length of 41 mm and a Approximate external diameter of 31.5 mm, which is smaller than the inner diameter of the casing body (1020). Other dimensions, lengths and diameters can be used for the cam disc (1010). The cam disc (1010) is structured with a transverse element (1011) and a core central (1012) that has an internal passage (1013) that allows the passage of the drive shaft (1110) through the disk shaft of cam (1010). The internal passage (1013) helps to maintain the drive shaft alignment (1110). Drive shaft (1110) is free to turn inside the internal passage (1013) with with respect to the cam disc (1010). The outer diameter of the cam disc (1010) has a slot (1014) around its circumference

The reel holder (1030) (figure 19A and B) is also cylindrical in shape, having the distal end (1037) and the near end (1034). The outer diameter of the Reel holder (1030) is smaller than internal diameter of the enveloping body (1020) but is larger than the end distal cam disc (1110). Similar to disk cam (1010), the reel holder (1030) has a transverse element (1031) and a central core (1032) equipped with an internal passage (1033). The drive shaft (110) and the flexible shaft (1070) are free to rotate in the passage internal (1033) with respect to the support (1030) of the reel.

The proximal end (1034) of the reel holder (1030)

it has a cavity (1037) that receives the distal end (1015) of the cam disc (1010), so that the end next (1034) of the reel holder (1030) overlaps with the cam disc (1010) and is between the body envelope (1020) and cam disc (1010). The overlap is large enough, so that when moving the support (1030) of the spool towards the distal end (1026) of the enveloping body (1020) (explained below), the proximal end (1034) of the reel holder (1030) continues to overlap with the distal end (1015) of the disc cam (1010).

The reel holder (1030) cannot rotate around of its longitudinal axis within the enclosure body (1020) by the fact that the pin (1250) extends through the hole (1035) at the proximal end (1034) of the bracket (1030) of the reel. The pin (1250) extends within the slot (1014) of the cam disc (1010) and through the slot (1024) at the proximal end (1023) of the body envelope (1020). The gear train (1700) spins the cam disc (1010) and turning said cam disc (1010), the pin (1250) moves along the slot (1024) due to the inclination of the slot (1014) on the cam disc (1010). When moving the pin (1250) axially along length (1024), displaces also the support (1030) of the spool axially. Of this mode, the reel holder (1030) is subjected to it movement that the pin (1250) and provides an indicator visual of the location of the reel holder and the

band position (310). If the pin (1250) is

move back and forth in the slot (1024), then the support (1030) of the reel will move equally back and forth.

They can be placed on the central core (1032) of the Reel holder (1030) a large band reel (1140) (Figures 20A and B) or a small band reel (1150) (figures 21A and B) or multiple band reels. He Band reel (1140, 1150) can be retained in your place by a displacement disk (1180) and the washer lock (1220). Between the reel (1140, 1150) of the band and transverse element (1031) of the support (1030) of the reel, a spring (1190), such as a flat spring, holds the web coil (1140, 1150) against the disk of displacement (1180). By turning the coil (1160), unwind the band (310) of the band reel (1140, 1150). A pressure spring (1200), such as a helical spring, It is located between the cam disc (1010) and the support (1030) of the reel, coaxially with the axle of drive (1110). The pressure spring (1200) maintains the effort in the band when moving the support (1030) of the reel axially backwards, no band remaining (310) blocked up. The pressure spring (1200) also helps Keep the components in place.

The band (310) from the band reel (1140, 1150) passes through the hole (1038) of the support (1030) of the reel and is inserted into the inner duct (1123) at the proximal end (1121) of the band guide conduit (1120). The band guide conduit (1120) is located in

the groove (1043) of the needle (1040). The near end

(1121) of the band guide conduit (1120) is coupled to the support (1030) of the reel with a hole (1036) at the distal end (1037) of the support (1030) of the reel. In this way, the support (1030) of the reel is axially displaces within the housing (1020), the band guide duct (1120) travels so similar, preferably axially back and forth front on the needle (1040). The distal end (1122) of the Guide duct (1120) of the band ends in the groove (1043) of the distal end (1041) of the needle (1040). He Band guide duct (1120) moves axially with with respect to the coil (1160), thus controlling the position along the axial length of the coil (1160) where the band (310) is located.

Coupled to the drive shaft (1110) between the support (1030) of the spool and cam disc (1010), is located a second stop disk (1170) and a lock washer (1230). A pressure spring (1210) is connected to the second stop disk (1170) and cam disc (1010). He pressure spring (1210), similar to the pressure spring (1200), helps keep the components in one position defined.

The enveloping body (1020) (figures 14A and B) is cylindrical in shape and has a near end (1023) and a distal end (1026) and receives the components previously described. The diameter of the enveloping body (1020) at the distal end (1026) decreases according to a Approximate angle of 45 degrees to one more diameter

reduced forming the nozzle (1021). Other forms are foreseen

and sizes for the enveloping body. Other slot (1025), perpendicular to the longitudinal axis of the enveloping body is located near the distal end (1026) of the body envelope (1020). This slot (1025) provides access to the band or bands (310) next to the band reel (1140, 1150) to allow the user to cut the band or bands

(310) once the mass of the coil / band has achieved Your desired dimensions.

In a multi-band configuration of the insertion device (1000) (figure 28), preferably the band guide conduit is not used (1120) or a cam disc (1010). I may not know require axial movement in the band winding multiple (310) around the coil (1160), however, if desired, axial movement can be arranged. A reason that axial movement may be unnecessary is that each of the bands (310) when passing through the holes (1038, 1039 and 1191) in the support (1030) of the coil and through the holes (1044, 1045 and 1046) of the needle (1040) is attached to the coil (1160) in one place different along the axis of said coil (1160), passing through holes (1164-1166). In the realization of bands multiple, different bands can be used dimensions, thicknesses and sizes to configure the shape of final implantation Preferably, the thickest band is wrap around the distal end (1163) of the coil (1160) with other thinner successive bands rolled to continuation of the previous band (310). In this way, at

turn the coil (1160), the multiple bands (310) are

They wrap around the coil. And when turning additionally the coil (1160), the bands extend naturally along the axis of the coil, creating a set of rolled band. Therefore, in a configuration of multiple band, the insertion device (1000) can operate by rotating the coil (1160) around the shaft longitudinal of the same with little or no axial movement around the longitudinal axis of the insertion device of the band (310) with respect to the coil (1160). From accordingly, the internal components of the body envelope (1020) may not require displacement axial in a multiple thread configuration. By way of similarly, the cam disc (1010) does not need to rotate.

To decouple the axial guide mechanism (1600), the drive shaft (1110) is moved in the near direction until a narrower section (1115) of the axis of drive corresponds to the location of the wheel of drive (1080). Since this section (1115) of the axis of drive is narrow and has no teeth, the teeth of the wheel (1080) do not interact with the drive shaft (1110). Accordingly, by rotating the drive shaft (1110) there is no corresponding interface between the axis of drive (1110) and gear train (1700). For this reason, the gear train (1700) does not turn and so therefore, no rotational force is applied to the cam disc (1010). Since the cam disc (1010) does not rotate, the Reel holder (1030) does not move axially.

The needle (1040) (figures 24A-C) may comprise three

additional holes (1044, 1045, 1046) instead of the

slot (1043). Each of the additional holes allows the introduction of a band (310) by it. Additional holes may have different diameters to adapt to different dimensions of the band. At if axial movement of the mechanism is not required guide (1600), the guide duct (1120) of the band it may be unnecessary and the bands can be inserted directly through the holes (1044, 1045 and 1046), as shown in figure 28.

The operation of the coil (1160) and the device Insertion (1000) will be described below. A band reel (1140, 1150), which contains a band (310) is fixed to the reel holder (1030) inside the body envelope (1020). The band (310) is passed from the band reel (1140, 1150) through the hole (1038) in the reel holder (1030) and through the guide duct of band (1120) along the needle (1040), so that the band (310) leaves the needle (1040) at its end distal (1041) and is coupled to the coil (1160) through one of the holes (1064, 1065 and 1066) of the coil (1160). Other means can be used to couple the band (310) to the coil (1160). The coil (1160) with the band (310) together with the needle (1040) is inserted into the

body

vertebral crushed by example, through a

cannula or a process

or surgical open rto.

He

Username make turn a mechanism from impulsion

causing the shaft to rotate (1110). This rotation causes that the cam disc (1010) and the flexible shaft (1070) can

turn. The plug (1250) arranged in the groove (1014) of the

cam disc (1010) causes the support (1030) of the reel moves axially back and forth, depending on the shape of the groove (1014). The movement axial of the reel holder (1030) is transferred to the guide line (1120) of the band, causing said band guide conduit (1120) moves axially on the needle (1040). This axial movement determines the location in which the band (310) is wound around the coil (1160). Meanwhile, the rotation of the flexible shaft (1070) causes the coil (1160) to rotate, which causes the rod (310) to unwind from the reel (1140, 1150) and be fed by the duct (1120) of guide the band and wrap around the coil (1160). When the coil (1160) has obtained the mass and shape desired, the user interrupts the rotation of the axis of drive (1110) and cut the band (310) through the perpendicular groove (1025) of the enclosure body (1020). Then, the user rotates the drive shaft (1110), so that the band (310) that remains in the conduit band guide (1120) is wrapped around the coil (1160). Once finished, the user pulls the shaft drive (1110), disconnecting the coil (1160) from the shaft flexible (1070), leaving the coil (1160) in the body vertebral Then, the user removes the needle (1040) from the vertebral body Alternatively, the user can pull the enclosure (1020) disconnecting simultaneously the coil (1160) of the flexible shaft (1070) and removing the insertion device (1000) from the body of the

patient. PMMA or other cement or cargo can be

inserted into the vertebral body along with the coil to further favor the fixation or repair of the damaged area Alternatively, the band (310) can be provided with a coating or may contain cement to bones or other material that can be activated during or After coil insertion, body winding.

As indicated above, multiple threads of varying diameters can be rolled over the coil to create the final implant (figure 28). This requires the insertion of multiple band reels inside of the enclosure body (1020) of the insertion device (1000) The bands coming from these reels are passed through the holes (1044, 1045 and 1046) of the needle (1040) shown in Figures 24A-C. I preferably don't know uses band guide conduit (1120) in a multi-band configuration (although they can be used one or more band guide ducts) and flexible shaft (1070) and coil (1160) preferably do not move from axial shape Preferably, the largest band is inserted in the hole (1045), so that it comes out in the far end of the needle (1040). The next band larger is preferably inserted into the hole

(1044),

from way that comes out from the needle (1040) by he

orifice

next (1045), such how be he has shown in the

figure 24B.

Before carrying out a procedure, the user can receive a series of insertion devices for the implantation of a coil (1160). Each of the

insertion devices can have a cam disc

different that has a different slot configuration. As explained above, the configuration of The groove partly determines the shape of the coil. Further, Each insertion device can include different band configurations or sizes. In this way, the user can choose the best insertion device to provide the desired set configuration of rolled band.

As an alternative, the user can remove the hood extreme (1100) to access internal components of the enveloping body (1020). In this way, the user you can swap cam discs (1010) and add band reels after the reel has run out of existing band. Once the proper configuration of cam disc (1010) and size

or band sizes in the envelope body, the user reattach the end cap (1100), fixing it with shear resistant pins (1260). Others means of access to the internal component of the device insertion, such as a rapid disassembly mechanism, It can also be used. The insertion device can be configured for simple uses or multiple. For example, you can make a device single use based on plastic and can be made of way that can not be reused. For example the body plastic wrap could be molded so that the reel of band material cannot be replaced without break the enveloping body or in such a way that the material

band cannot be rolled again in the

duct / guide wire of the band once it has been cut and rolled on the coil. Alternatively or additionally, the connection between the coil and the shaft flexible could break down when the coil is uncoupled of the flexible shaft, so that a new coil is not will fit or adapt to the flexible shaft. If the device insertion is configured to be reusable should consider sterilizing the device for Next use, which may require different materials instead of single use applications.

Figure 29 shows the use of a flexible shaft which has four unions (1500). The joints (1500) can take the form of universal unions. This configuration Flexible shaft (1070) allows the coil to remain parallel to the needle (1040). Figure 30 shows the use of a flexible shaft that has two joints Universal (1500). The configuration allows the axis Flexible support the coil at a predetermined angle.

In some embodiments, the band (310) may be rolled inside a sheet (2000) with the capacity to curved, such as a sheet of metal, plastic, Teflon or other material, being wrapped around a coil. For example, Figure 31A shows a cross section by the end of a coil, for example, a coil (600), which has a rolled element (2000) rolled around a coil (600) before winding the band (310). Referring to Figure 31B, when rolling the band (310) around the coil (600), the element

Laminar (2000) expands as the diameter increases

coil (612). This expansion can force the item laminate (2000) out, for example, against structures located inside the vertebral body (12). In other embodiment, a bag, elastic or expandable balloon or other structure that may or may not have a default form can be used instead of the laminar element (2000) or additional form thereto, around the coil (612) that It can expand into the vertebral body (12) by increase the coil size.

Referring to Figure 32, the coil (2100) it can be curved instead of having joints, as it has been described above or additionally thereto. A curved coil (2100) of this type can help optimize repositioning and augmentation of bones damaged by conformation inside the vertebral body (12) and applying a stabilizing force against the inner walls of the vertebral body (12). These coils with capacity of curved can be formed with different materials, such as polymers, metals, biomaterials or any Other compatible materials.

As mentioned in the above, you can use a series of coil types that have different geometries and other features and properties. For example, the coil can be a coil straight (300) or a curved coil, such as the coil (2100) and can comprise a series of material. In others embodiments, a coil (600) may have unions, such such as unions (614) and (616) to allow movement

of each of the parts (601, 603 and 620) to

provide the desired orientation and configuration of the coil (600) inside the vertebral body or other structure to repair, decompress or otherwise manipulate.

Although the device described so far has been in the context of repositioning and body augmentation vertebral after vertebral fractures by compression, other different uses can be provided. By example, in some embodiments, a coil, such as the coil (300) and band (310), can be used to reposition and / or increase other areas of damaged bones, such as weakened proximal areas (1400) weakened or fractured, as shown in figures 34A and

B. In these embodiments, the coil (300) can be inserted by a cannula and may include an extension (1800) to which it is detachably connected, the coil (300) can have different characteristics, such as described elsewhere in this text. After that the band (310) has been wrapped around the coil, the body of the rolled band (312) can be uncoupled from the extension and left in position in the femur. The cavity that remains for the extension and volume surrounding the body of rolled band can be filled with bone cement, bone chips or others materials for integrating the body of the wound belt into bone.

Bone augmentation devices / systems that have been described can be used for other purposes other than the femur and vertebrae.

While the description and drawings above represent the preferred embodiments of the present invention, it will be understood that they can be performed in the same different additions, modifications and substitutions without leaving the scope of the present invention, as defined in the appended claims.

Claims (23)

1. Bone treatment system comprising: A) an elongated body (300) configured for implantation within a bone and that has a first and a second ends that define a longitudinal axis of said elongated body (300), and a diameter (302) transverse with with respect to said longitudinal axis; Y B) a band (310) having a length substantially greater than its width or height, being configured the band (310) to establish contact and wrap multiple times around said body elongated (300) between said first and second ends for increase the diameter (302) of said elongated body (300) when implanted inside the bone; and in which the wrapping of the band (310) around said body elongated (300) can be carried out manually or with help of a mechanized tool, characterized in that said system further comprises a guide mechanism configured to control the position of the band (310) between the first and second ends of said elongated body (300) when said band (310) is wound around said elongated body (300).

2.

System according to claim 1, wherein said elongated body (300) takes the form of a coil.

3.

System according to claim 1 or 2, which it also comprises a longitudinal element (520) that has a near end and a distal end, being configured the near end for user manipulation

outside the patient to place said distal end in a desired position within a bone; and in which a union (514) is disposed between said second end of said elongated body (300) and said distal end of said longitudinal element (520).

Four.

System according to one of claims 1 to 3, in which the elongated body (300) is cylindrical and it comprises a hole through which a part of said passage passes band (310).

5.

System according to one of claims 3 or 4, wherein said longitudinal element (520) comprises, as minimum, a part of a drive device (840) for

do

turn saying body elongate (300) when is

implanted

inside of the bone, being configured saying

element

longitudinal (520) for its turn, Y being

configured said joint (514) to transfer rotation from said longitudinal element (520) for the rotation of said elongated body (300), and wherein said joint (514) it is removable, so that said longitudinal element (520) can be decompressed with respect to said body elongated (300). 6. System according to one of claims 1 to 5, which also includes -a drive device (840) configured to detachably coupled with said elongated body (300) and rotate it, said device having drive (840) a proximal end and a distal end, the near end being configured in its use to extend from the patient's body and be manipulated by a user to place the distal end in the desired position in the bone, the distal end being detachably connected to said elongated body (300), so that the drive device (840) can rotate to cause the rotation of said elongated body (300) when said elongated body (300) is located in a bone; Y -a guide mechanism comprising a mobile guide with respect to said elongated body (300) to control the position of the band (310) between said first and second ends when the band (310) is wrapped around said elongated body (300).

7.

System according to claim 6, wherein said drive device (840) comprises a rotating shaft and The guide mechanism comprises an elongated coaxial tube with the rotary axis, the elongated tube being movable in axial direction with respect to said elongated body (300) and establishing contact the band (310) to position said band (310) between the first and second ends of said elongated body (300).

8.

System according to claim 7, comprising also a button, connected to the elongated tube and containing a guide hole for the band (310).

9.

System according to claim 7 or 8, wherein said elongated body (300) has thread fillets for help guide the band (310).

10.

System according to claims 6 to 9, in the that the drive device comprises a rotating shaft which has a near end and a distal end, being the

distal end of the shaft can be connected detachably and with rotational capacity at the first end of said body elongated (300), the axis being able to transfer torque of forces to said elongated body (300), and in which the guide mechanism comprises a guide tube provided with a proximal end and a distal end through which it travels the band (310), the guide tube being movable axially with respect to the axis.

eleven.

System according to claim 10, wherein the Rotary shaft and guide tube are located on a needle, the rotary axis being axially fixed with respect to the needle and moving the guide tube axially with with respect to the needle, so that a part of the needle it is arranged along said elongated body (300) and adjacent to it.

12.

System according to claim 9 or 10, which further comprises a drive assembly to convert the rotary movement of the drive device in a axial movement, the drive assembly being connectable to the drive device and guide tube to move axially to said guide tube.

13.

System according to claim 12, wherein the drive assembly comprises a connectable sprocket with the rotary drive assembly, a cam disc rotary and axially movable follower but not rotating, the cam disc having a groove along of its outer surface and the follower comprising a projection, which extends into the groove.

14.

System according to claim 13, wherein the follower is a reel holder and the projection is a pin inserted through a hole in the reel holder.

fifteen.

System according to one of claims 1 to 14, in which the band (310) is coated or It is part of a matrix with other materials to include osteoinductive materials, osteoconductive materials, antibiotics, tricalcium phosphate and morphogenetic proteins of bone

16.

System according to one of claims 1 to 15, in which the band (310), which has characteristics of radiopacity, is at least tensile resistant 100 N, and in which the band (310) slides along the bone tissue but not along the outer diameter of said elongated body (300).

17.

System according to one of claims 1 to 16, in which the band (310) may be composed of a suture material, metal, metal with coating of bone material, metal with a surface of one polymer that allows the welding of said elongated body

(300) and surrounding tissues. 18. System according to one of claims 1 to 17, comprising an insertion device for insertion said elongated body (300) within a bone, said insertion device comprising a device of drive to apply the rotational force to said elongated body (300) to make said elongated body (300) rotate around its longitudinal axis to roll said band (310) around said elongated body (300), to increase said elongated body diameter (300) and band set implanted within an area of a bone.

19.

System according to claim 18, comprising furthermore an axially movable axial guide mechanism with respect to said elongated body (300), being said axial guide mechanism in connection with the position of the band (310) and controlling it, along the length of said elongated body (300) while rotating.

twenty.

System according to claim 18 or 19, in the that the drive device comprises a rod connected to said elongated body (300), being rotatable the rod that in turn rotates said elongated body (300), so that the guide mechanism comprises a cannula external, causing the band (310) to reposition as length of said elongated body (300), and

wherein the continued rotation of said body elongated (300) causes the diameter of said body elongated (300) and the band set increase due to winding of the band (310) around the body long (300).

twenty-one.

System according to claim 19 or 20, in the that

the drive device comprises a mechanism of drive, drive shaft and flexible shaft connected in series to said elongated body (300); understanding the guide mechanism a band guide conduit, a reel holder and a rotating cam disc; in which the cam disc and the reel holder convert the rotational force of the cam disc into a oscillating force applied to the band guide conduit, causing the band guide conduit to move forward and backward with respect to said body elongated (300); Y wherein the band guide conduit comprises a interior passage that has a proximal opening and an opening distal and in which the band is disposed within the passage inside the band guide duct, and moves by the same, leaving the distal opening where it is rolled around said elongated body (300).

22

System according to claim 21, wherein the insertion device further comprises a set impeller to couple the drive shaft of the device of drive to the cam disc of the guide mechanism, to effects of the cam disc rotating at a speed different than the drive shaft, so that the whole impeller comprises a gear train, a pinion and another wheel.

2. 3.

System according to one of claims 18 to 22, for minimally treating bones invasive, in which said insertion device is detachably connectable to said elongated body

(300) and which also includes: a drive device to apply the force of rotation to said elongated body (300) to make said elongated body (300) rotate around its longitudinal axis to wrap said band (310) around said body elongated (300), to increase the diameter of said elongated body (300) and band set implanted inside of the area of a bone, said device comprising drive a drive mechanism, a drive shaft and a flexible shaft connected in series to the first end of said elongated body (300); an axially movable axial guide mechanism with with respect to said elongated body (300), the axial guide mechanism in connection and controlling the position of said band (310) along the length of said elongated body (300), while rotating, the guide mechanism comprising a guide duct of the band, a reel stand and a cam disc rotary, in which the cam disc has a groove at along its outer surface and reel holder it comprises a projection, whose projection extends towards inside the cam disc slot, and a drive assembly that couples the drive shaft from the drive device to the cam disc of the mechanism guide for the purpose of making the cam disc rotate at a speed other than the drive shaft, comprising the drive assembly a drive wheel, a pinion and another wheel, in which the cam disc and the reel holder convert the rotational force of the cam disc into a oscillating force applied to the band guide conduit, causing the band guide conduit to move forward and backward with respect to said body elongated (300), and wherein the band guide conduit comprises a interior passage that has a proximal opening and an opening distal and in which the band is arranged inside the passage inside the band guide duct, moving 5 therethrough, out of the distal opening, where it is wound around said elongated body (300), so that the flexible shaft and the band guide conduit are located in a needle, the flexible shaft is axially fixed with respect to the needle and the guide duct of 10 the band moves axially with respect to the needle, in which a part of the needle is arranged along and adjacent to said elongated body (300), and in which the continuous rotation of said elongated body (300 ) causes the diameter (302) of said The elongated body (300) and the band assembly increase due to the winding of the band around said elongated body (300).