CZ444299A3 - Systems for treating broken or sick bones by making use of expansible bodies - Google Patents

Abstract

The systems introduce at least one extensible body (56) into bone. Expansion of the extensible body (56) or body it creates one or more cavities in the lattice bone in the inner bone volume (30).

Description

Technical field

The present invention relates to the treatment of bone conditions in humans 5 and animals.

BACKGROUND OF THE INVENTION

When a lattice bone becomes ill, for example due to osteoporosis, avascular necrosis or cancer, the surrounding cortical bone becomes more susceptible to compression fracture or collapse. This is because the lattice bone no longer provides internal support for the surrounding cortical bone.

In the US, for example, 2 million fractures occur each year, of which approximately 1.3 million are due to osteoporosis alone. There are other bone diseases that include, for example, infected bone, poorly healing bone, or broken bone in a severe trauma. These conditions, if not treated successfully, can result in deformation,

2q chronic complications and overall may adversely affect quality of life.

U.S. Patent Nos. 4,969,888 and 4,969,888. No. 5,108,404 disclose devices and methods for fixing fractures or other conditions of human or animal bone systems, both osteoporous and non-osteoporous. The devices and methods of these patents utilize an expandable body to compress the lattice bone and form an internal cavity. This cavity receives a restorative material that solidifies and creates by restoring the internal structural support for the cortical bone.

• · · · · · · · · · · · · ·

Many internal areas of the body, such as vascular tissue and internal bones, have complex, asymmetric geometries. Even if the inner region of the body is somewhat more symmetrical, it may still be difficult to reach along the natural axis of symmetry.

For example, the use of the expandable structure in the region of the branched arteries or veins may position the axis of the expandable structure out of alignment with the axis of the blood vessel that the structure is intended to occupy. For example, the insertion of an extensible structure into the bone θ may require the creation of an entrance gate that is not in alignment with the natural bone symmetry. In such cases, the stretching of the structure is not symmetrical with respect to the natural axis of the area to be treated. As a result, the stretching of the body is not symmetrical with respect to the natural axis of the target area.

It may also be important to maximize the size and surface area of the extensible structure when used in the inner region of the body. Current medical balloons produced by molding techniques are designed to be introduced into a narrow channel, such as a blood vessel or fallopian tube, where they are then inflated. -In this environment, the balloon diameter is a critical value for its success, but the length is less important. Such balloons need only be long enough to cross the area of intended use, with a small margin of 5 behind the effective portion of the inflated balloon. This allows conventional balloons to be constructed in three molded portions, including a cylindrical middle section and two conical ends connected to the catheter tube. For practical reasons, neither the length of the conical end nor the length of the balloon-catheter tube joint affect the function of conventional balloons, and these areas on conventional balloons often have a length of 1 cm or more. In fact, the larger the diameter of the balloon, the longer the conical end, creating a match between the maximum effective length and the maximum effective diameter. This consistency presents a problem in optimizing conventional structures in internal structures with defined lengths, such as bone.

Better and more effective bone healing promised by the aforementioned patents can be fully realized with improved systems for creating and using extensible bodies in

SUMMARY OF THE INVENTION

The present invention provides improved bone treatment systems, including vertebral bones and other bone types, using one or more expandable bodies.

One aspect of the present invention provides systems for treating or treating bone using an expandable wall in conjunction with a material ejection nozzle. According to this aspect of the present invention, the systems insert both the body and the nozzle into a bone having a cortical bone surrounding an internal volume occupied, at least partially, by a lattice bone. These systems cause the body to assume expanded geometry when it occupies the inner volume in the presence of a nozzle to compress the lattice bone and form a cavity in the inner volume. These systems convey the material to be discharged through the nozzle into the cavity at least partially while the body occupies an internal volume.

In a preferred embodiment of the present invention, the systems convey bone mastic (cement) for discharging through the nozzle while the body is in expanded geometry or partially in expanded geometry. The systems can also cause the expanded geometry of the body to reduce volume relative to the volume of material discharged through the nozzle into the cavity.

In one embodiment of the present invention, the extensible body and nozzle are introduced separately into the target bone. In a preferred embodiment of the present invention, the expandable body and the nozzle form an integrated tool and are introduced simultaneously into the target bone.

Another aspect of the present invention provides bone treatment systems using the first and second extensible bodies. The first extensible body is inserted into the inner bone volume through the first access path in the cortical bone. The second extensible body is inserted into the same inner bone volume through a second access path in the cortical bone that differs from the first access path. These systems and procedures cause each of the bodies to assume an expanded geometry to co-compress the lattice bone to form a cavity in the internal volume.

Another aspect of the present invention provides a bone insertion body that includes two extensible zones. The first zone occupies an elongated extended geometry. This elongated stretched geometry presents a first dimension that extends substantially across the inner volume to form a barrier within the inner volume. This elongated geometry also presents a second dimension, less than the first dimension, leaving an area of substantially uncompressed lattice bone that extends from the barrier within the inner volume. The second extensible zone occupies a different expanded geometry that compresses the lattice bone to form a cavity in this ·

areas. The barrier formed by the first zone directs the expansion of the second zone in the area away from the first zone.

In one embodiment of the present invention, the first and second extensible zones comprise separate extensible assemblies. In another embodiment of the present invention, the first and second extensible zones comprise portions of one extensible assembly.

Another aspect of the present invention provides a device for introduction into an inner region of the body that includes a catheter tube that supports an expandable structure. The structure is adapted to receive the composite geometry for introduction into the inner body region and the expanded geometry for use within the inner body region. The catheter tube extends along the first axis. The expanded geometry of the structure is oriented about 15 of the second axis, which is not aligned with the first axis. This asymmetry between the two axes allows the extensible structure to be introduced symmetrically with respect to the natural axis of the target body region, even when the catheter tube is not aligned with this natural axis.

In a preferred embodiment of the present invention, said device is intended to be inserted into a bone having a cortical bone surrounding an inner volume occupied by at least partially a lattice bone. In this embodiment, the expanded geometry of the structure compresses the lattice bone to form a cavity in the internal volume. The asymmetry between the axis of the catheter tube and the axis of the expanded geometry of the structure allows the formation of a cavity centrally relative to the middle region of the inner volume, even if the access path

3Q follows the catheter tube, not in alignment with any natural axis of inner volume.

• · • 0

Another aspect of the present invention provides a device for introduction into an inner region of the body that includes a catheter tube that supports an expandable structure. The catheter tube has a first diameter and the structure, when substantially expanded, has a second diameter greater than the first diameter.

The design includes spaced end regions. At least one of the end regions forms a transition with a non-conical diameter between the first and second diameters. The transition with a non-conical diameter makes it possible to achieve the desired maximum expanded diameter without unduly limiting the effective length of the structure.

This aspect of the present invention is advantageously used in the manufacture of devices intended to be introduced into the lattice bone to compress the lattice bone by expanding the structure and thereby forming a cavity. The presence of _{γ γ} non-conical end regions allows the volume of maximum compression of the lattice bone to be increased.

In a preferred embodiment of the present invention, the end regions are turned around the catheter tube. These inverted end regions allow compression of the lattice bone along the entire length of the extensible structure.

Another aspect of the present invention provides an apparatus for introduction into an inner region of the body that includes an inner catheter tube and an outer catheter tube. The distal end of the inner catheter tube extends beyond the distal end of the outer catheter tube. The proximal end of the extensible body is connected to the distal end of the outer catheter tube, while the distal end of the extensible body is connected to the distal end of the inner catheter tube. The expanding medium fills

5Q the interior of the expandable body through the space between the two catheter tubes. Inner catheter tube and extensible • ·

The body is made of materials that are more compliant than the catheter outer tube, so that the length of the expandable body increases in proportion to the diameter.

In a preferred embodiment of the present invention, the materials for the extensible body and inner catheter tube include more compliant polyurethanes, while the materials for the outer catheter tube include less compliant polyurethanes or polyethylenes.

Another aspect of the present invention provides an apparatus for introduction into an inner region of the body that includes a catheter tube that supports an expandable structure and includes a probe wire within the structure to reinforce it.

In a preferred embodiment of the present invention, the probe wire 5 includes a memory that typically bends the probe wire to deflect the structure relative to the catheter tube. The structure is slidably enclosed in the housing during insertion. The housing overcomes the probe wire memory for pushing the probe wire into a generally upright configuration. The memory bends the probe wire and deflects the structure when the structure slides freely from the housing.

Another aspect of the present invention provides a sterile kit comprising a bone delivery device that includes a structure adapted to receive expanded geometry having the desired configuration in use. This structure is subjected to stress when it is stretched during its first use in the bone. As a result, this structure cannot be relied upon to achieve its desired configuration during subsequent bone use. The kit includes an overwrap defining a sealed sterile container to keep the device sterile until use. The kit confirms to the physician or user that the device packaged therein is sterile and has not been subjected to prior use. The physician or user is thereby assured that the extensible structure meets the set performance and sterility specifications and will have the desired configuration when extended for use.

The features and advantages of the present invention will be somewhat more apparent from the following detailed description of exemplary embodiments with reference to the accompanying drawings, as well as from the θ appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

Fig. 1 shows a side view of the human spine;

Giant. 2 is a cross-sectional view of the lumbar vertebra 15, partially cut away and in section taken generally along the plane 2-2 of FIG. 1;

Giant. 3 shows a vertical section of the lumbar vertebra;

Giant. 4 shows a plan view of a probe comprising a catheter tube 20 supporting an expandable bone treatment body;

Figures 5A-5P show a series of cortex views, partially cut away and in section, illustrating the steps of insertion, through transpedicular access, of an expandable body to compress the lattice bone and create a cavity within the vertebral body, and then the steps of delivering padding material to the cavity for restoring the intrinsic integrity of the cortical bone;

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Fig. 5Q

Fig. 5Q

Giant. 6 5

Giant. 6 5

Fig.7

Fig.7

Fig. 8A

Fig. 8A

Fig. 8B 25

Fig. 8C

Fig. 8B 25

Fig. 8C is a side view with parts removed of the vertebra shown in the cross-sectional view of Fig. 5P;

shows a corpus view of the vertebral body in which the expandable body, limited by the outer sealing member, compresses the lattice bone to form a cavity;

shows an end view, partly with cut off parts and in section, of a vertebral body in which the extensible body is folded after the cavity has been formed, while the injection tip, also inside the vertebral body, simultaneously injects the cushioning material into the cavity;

illustrates a cross-sectional view of the vertebral body, partially cut away and in section, illustrating a tool that integrates an injection tube and an integral extensible body to form a cavity in a lattice bone, as well as illustrating injection of filler material while folding the extensible body;

shows a side view of the tool illustrated in Fig. 8A located outside the bone;

Fig. 8B is a cross-sectional view of the tool illustrated in Fig. 8B taken generally along the line 8C-8C in Fig. 8B;

Giant. 9 30

Giant. 9 30 is a cross-sectional view of a vertebral body illustrating multiple extensible bodies flflfl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl fl

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Fig.12

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Fig.13

Fig.13

Fig.14 25

Figure 14 of 25 self-transpedicular approaches;

shows a view of the distal end of the probe, in which two catheter tubes, each carrying an expandable body, are joined to create a symmetrical field when the bodies are substantially extended outside the bone;

shows a view of the distal end of the probe in which two catheter tubes, each carrying an expandable body, are joined to create an asymmetric field when the bodies are substantially extended outside the bone;

shows a coronal view, partly with cut off sections and in section, of a vertebral body in which multiple extensible bodies have already been introduced via a double transpedicular approach;

shows a coronal view of the vertebral body, partially with cut off parts and in section, in which multiple extensible bodies have already been introduced through a two-sided posterolateral approach;

shows a coronal view of the vertebral body, partially with cut off portions and in section, in which a plurality of extensible bodies have formed multiple cavities that merge to form a single cavity to receive the filler material;

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Fig. 15 is a cross-sectional view of a vertebral body, partially cut away, in which multiple expandable bodies have formed multiple discrete cavities for receiving padding material;

Figure 16 is a front-rear view of the spine region illustrating multiple extensible bodies present within the target vertebra body using a one-sided posterolateral approach;

Fig. 17 shows a front-rear view of the vertebral body, partially cut away, and in cross-section, in which multiple extensible bodies introduced using the one-sided posterolateral approach have formed multiple cavities that merge to form a single cavity for receiving padding material;

Fig. 18 shows a front-rear view of the vertebral body, partially with the portions cut away, and in cross-section, in which multiple extensible bodies introduced using the one-sided posterolateral approach have formed multiple discrete cavities for receiving padding material;

Fig. 19 is a cross-sectional view of the vertebral body, partially cut away and in section, in which multiple extensible bodies have been introduced by both the transpedicular and posterolateral approaches;

· «« «·« «« «« «« «« ««

20 is a perspective view of one representative embodiment of an expandable body having a composite toroidal shape geometry;

Fig. 21 shows a view of another representative embodiment of an expandable body having an elongated shape geometry;

Fig. 22 is a side elevational view of another representative embodiment of the expandable body illustrating three composite bodies and spring clips to limit the expansion of the bodies during inflation;

Fig. 23 is a perspective view of another representative embodiment of an expandable body having bean-shaped geometry;

Fig. 24 shows a top view of another representative embodiment of an expandable body having bean-shaped geometry with several compartments by means of a heating element or a marking tool;

Fig. 25 is a cross-sectional view taken along lines 25-25 of Fig. 24;

Fig. 26 is a side perspective view of the vertebral body, partially cut away, to illustrate the presence of the extensible body as well as to illustrate the major reference dimensions of the extensible body;

Fig. 27 shows a dorsal view of a representative extensible body having the geometry * φφφφ φ φ • φφφ φ φ

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Fig. 28 is a cross-sectional view of the extensible body illustrated in Fig. 27, taken generally along the plane 28-28 of Fig. 27;

Fig. 29A shows a representative extensible body having a spherical shape with a base positioned in the proximal humerus and seen from the front (front) of the left proximal humerus;

Fig. 29B shows a representative extensible body having a cylindrical shape disposed in the proximal humerus and seen from the front (front) of the left proximal humerus;

Fig. 30A shows a representative embodiment of a placed extensible body as illustrated in a frontal (front) view of the proximal tibia inserted under the middle tibia plateau;

Fig. 30B shows a side view of the expandable body illustrated in Fig. 30A;

Fig. 30C is a top perspective view of the extensible body illustrated in Fig. 30A, showing the generally cylindrical geometry of the extensible body;

Fig. 31 shows a plan view of another representative embodiment of an extensible body for use.

In the treatment of fractures of the tibia, which has generally elliptic geometry;

Fig. 32 shows a side view of a plurality of expandable bodies stacked one on top of another for use, for example, in the treatment of fractures of the tibia plate;

Fig. 33 shows another representative embodiment of a placed extensible body having an ovoid geometry as illustrated in a frontal (front) view of the proximal tibia inserted under the middle tibia plate;

Fig. 34 shows a representative embodiment of an expandable body having a spherical geometry for treating avascular necrosis of the femoral head (or the humerus), which is shown from the front (front) of the left hip;

Fig. 35 is a side view of another representative embodiment of an expandable body having a hemispherical geometry for treating avascular necrosis of the femoral head (or humerus);

Fig. 36A shows a view of a representative extensible body having a bent geometry to prevent a hip fracture as illustrated from the front (front) of the left hip;

Fig. 36B shows a view of a plurality of extensible bodies individually introduced through a plurality of ft · ····

left hip access points to prevent hip fracture;

Fig. 37A shows a view of a representative extensible body having an asymmetrical bow tie shape for use in treating the heel bone fracture illustrated in a side view within the heel bone;

Fig. 37B shows a top perspective view of the extensible body illustrated in Fig. 37A when substantially expanded outside the calcaneus;

Fig. 38 shows a representative embodiment of an expandable body having a spherical or egg-shaped geometry illustrated in a side view introduced within the calcaneus;

39A-39D illustrate a multiphase process for introducing filler material into a cavity formed by an expandable body in a lattice bone to prevent or impede flow or leakage of the filler material from within the bone;

Fig. 40 shows a side view of the injection tip for

Fig. 41 is a cross-sectional, cross-sectional view of the vertebra illustrating a filler material over which a mesh is stretched which, upon insertion in a cavity formed by the expandable body, makes it difficult or impeded leakage of material from the cavity;

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0 0 0 0 0 0

Giant

Giant

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Figure 40 shows the insertion of the mesh shown in Figure 40 inside the vertebral body;

42A to 42C are schematic illustrations of a representative procedure and system for administering a therapeutic substance to a bone using an extensible body;

shows an illustration of a human skeleton illustrating regions of long bones that can be treated using extensible bodies;

illustrates a representative embodiment of a plurality of placed expandable bodies, as shown in the front view, within the proximal tibia, both of which are inserted below the middle tibia plate, one of the bodies being substantially expanded to form an inner barrier and serving as a platform for a second body which is shown substantially folded;

shows a front (front) view of a plurality of extensible bodies illustrated in Fig. 44, both bodies being in substantially expanded states to form a cavity within the proximal tibia below the middle tibia plateau;

shows an enlarged front (front) perspective view of a plurality of extensible bodies illustrated in Figure 45, wherein

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0 • 0 • 00,000 · * · 0000 0 0 • 0 0 0 • 0 • 0

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0 0 0 0 0 0

0 0 the lower expandable body serves as a platform for the upper expandable body;

Fig. 47 shows a schematic view of a system for obtaining a marrow in a bone forming a marrow using an expandable body;

Fig. 48 is a cross-sectional view of the catheter tube associated with the system illustrated in Fig. 47, taken generally along the plane 48-48 of Fig. 47;

Fig. 49 is an enlarged view of the extensible body associated with the system illustrated in Fig. 47, inside the bone for bone marrow harvesting purposes;

Fig. 50 shows a top view of a probe comprising a catheter tube carrying a tubular extensible structure illustrated in a substantially collapsed state;

Fig. 51 is an enlarged side view of the tubular extensible structure supported by the probe illustrated in Fig. 50, which is shown in a substantially expanded state;

Fig. 52 is a side view of the lumbar vertebra, partially with the portions cut away and in cross-section, with the extensible structure illustrated in Figs. 50 and 51 introduced, which is in a substantially collapsed state;

* · «··· • * · · · · · · · · · · ·. * · · · · · · · · · · · ·

·· ··

Fig. 53 is a cross-sectional view of the approach shown in Fig. 52, partially cut away;

Fig. 54 is a side elevational view of the approach illustrated in Fig. 52 with the extensible structure illustrated in Figs. 50 and 51 in substantially extending a state forming a cavity that is not centered with respect to the central region of the vertebral body;

Fig. 55 is a cross-sectional view of the approach shown in Fig. 54, partially cut away;

56A and 56B show side elevations of improved extensible structures, each having a canine stretching that is shifted at an acute angle and not aligned with the axis of the catheter support tube;

Fig. 57 is a side elevational view of the lumbar vertebra, partially with the portions cut away and in cross-section, with the deployed, expandable structure illustrated in Fig. 56A displaced in a substantially expanded state to form a cavity substantially centered relative to the middle region vertebral bodies;

58A and 58B are side views of other embodiments of improved extensible structures, each having an extension axis that is offset a distance from the axis of the catheter support tube;

. * ·. ί · · · * * * · · · · · · · „„

Fig. 59 is a side elevational view of the conventional extensible structure illustrated in Fig. 51, enlarged to illustrate further details of its geometry when substantially expanded;

Fig. 60 is a side elevational view of an improved extensible structure when in a substantially expanded state that includes end regions having compound curves that limit the length of the end region and thereby provide the capability of maximally compressing the bone substantially along the entire length of the structure;

Fig. 61 shows a side view of an improved extensible structure when in a substantially expanded state that includes end regions having compound curves that revert end regions around the ends where the structure is connected to the catheter support tube to substantially maximize bone compression along the entire length of the structure;

Fig. 62 shows a side view of an improved extensible structure when in a substantially expanded state that includes end regions that have been formed or folded around terminations in which the structure is connected to the catheter support tube to provide the capability of maximally compressing the bone substantially along the entire length construction lengths;

·······················································

Fig. 63 shows a side view of a tubular expandable structure having a distal end connected to an inner catheter tube and a proximal end connected to an outer catheter tube, wherein the inner catheter tube is slidably disposed within the outer catheter tube;

Fig. 64 is a cross-sectional side view of the tubular extensible structure illustrated in Fig. 63 after sliding the inner catheter tube within the outer catheter tube to invert the end regions of the structure around distal and proximal joints, thereby ensuring maximum bone compression capability substantially along the entire length of the structure;

Fig. 65 is a cross-sectional side view of a tubular expandable structure having a distal end coupled to an inner catheter tube and a proximal end coupled to an outer catheter tube, wherein the inner catheter tube and structure are made of more compliant material than the outer catheter tube to provide length and diameter proportions stretching;

Fig. 66 shows an enlarged plan view of a branched area of blood vessels in which an occlusion exists;

Fig. 67 is another enlarged view of the branched area of the blood vessels illustrated in Figs.

66, in which asymmetric is introduced.

an extensible structure of the type shown in Fig. 56A for opening the occlusion;

Fig. 68 is a side view, with parts cut away and in cross-section, of an extensible structure having a closed reinforcing element for strengthening the structure during passage through the guide jacket to the inner region of the body;

Fig. 69 is a side elevational view of the extensible structure illustrated in Fig. 68, after insertion under the guide skirt and into the inner body region, wherein the reinforcement element comprises a distal region having a pre-formed bend that deflects the structure relative to the axis of the guide skirt;

Fig. 70 is a plan view of a sterile disposable probe mounting kit that supports extensible structures as shown previously; and

Fig. 71 is an exploded perspective view of the sterile set shown in Fig. 70.

DETAILED DESCRIPTION OF THE INVENTION

The present invention may be practiced in several 25 forms without departing from the scope or spirit of the invention. The scope of the present invention is defined in the appended claims and the description of specific embodiments that precede these claims. All embodiments falling within the general meaning and scope of equivalence of the claims are therefore covered by these claims.

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9 9 9 9 • ··· · · ·

This application describes novel systems and methods for treating bone using extensible bodies. The use of extensible bodies is described in US Patent Nos. 4,969,888 and 5,108,404, which are hereby incorporated by reference. Improvements in this field are described in U.S. Patent Application Serial No. 08 / 188,228, filed January 26, 1994; U.S. Patent Application Serial No. 08 / 485,394, filed June 7, 1995; and in U.S. Patent Application Serial Number

No. 08 / 659,678, filed June 5, 1996, all of which are also incorporated herein by reference.

The new systems and methods will first be described in connection with the treatment of vertebrae. It should be understood, however, that these systems and methods described in this manner are not limited to use by the vertebrae only. As will be described in more detail later, the systems and methods of the present invention are useful for treating a wide variety of bone types.

I. Treatment of vertebral bodies

As shown in Figure 1, the spine 10 includes a number of uniquely shaped bones, called vertebrae 12, sacrum 14 (or also cross), and skeletal bone 16 (also called coccyx). The number of vertebrae 12 forming the spine 10 depends on the animal species. In a human (whose spine 10 is shown in FIG. 1) there are twenty-four vertebrae 12 that include seven cervical vertebrae 18, twelve thoracic vertebrae 20, and five lumbar vertebrae 22.

Viewed from the side, as illustrated in FIG. 1, the spine 10 forms an S-shaped curve. This curve serves to support a head that is heavy. In four-legged animals, the spine curve is somewhat simpler.

As shown in Figures 1 to 3, each vertebra 12 includes a vertebral body 26 that extends on the front (i.e., ventral or thoracic) side of the vertebra 12. As shown in Figures 1 to 3, the vertebral body 26 has the shape of an oval plate.

As shown in Figures 2 and 3, the vertebral body 26 comprises an exterior formed of compact cortical bone 28. The cortical bone 28 encloses the inner volume 30 of the veined lattice-like or spongy-like bones 32 (also called medullary or medullary bone or trabecular bone). A pillow, called the intervertebral disc 34, is positioned between the vertebral bodies 26.

The aperture, called the vertebral foramen 36, is located on the back (i.e., the back) side of each vertebra 12. The spinal ganglion 39 passes through the foramen 36. The spinal cord passes through the spinal canal 37.

The vertebral arch 40 surrounds the spinal canal 37. The vertebral shank 40 abuts the vertebral body 26. The mandrel projection 44 extends from the back of the vertebral arch 40, with transverse projections 46 extending left and right.

A. Introduction of the extensible body

Giant. 4 illustrates a tool 48 for preventing or treating a compression fracture or collapse of a vertebral body using an expandable body.

The instrument 48 includes a catheter tube 50 having a proximal end 52 and a distal end 54, respectively. The distal end 54 carries an expandable body 56.

»· · · · · · · · · · ·

The extensible body 56 comprises an outer wall 58, which is shown in composite geometry in FIG. The composite geometry allows the expandable body 56 to be inserted into the internal volume 30 of the target vertebra body 26.

The insertion of the expandable body 56 into the internal volume 30 of the target vertebral body 26 can be accomplished in a variety of ways. Giant. Figures 5A-5Q illustrate the insertion of the extensible body 56 using a transpedicular approach that can be performed by either a closed or ¹⁹ minimally invasive procedure or an open procedure.

In the procedure described, the patient lies on an operating table while the physician introduces a conventional spinal needle assembly into the soft tissue of the patient's back. The patient may lie face down on the operating table, or on any side, or at an oblique angle, depending on the choice of the physician. In addition, this procedure may be performed through an open procedure from the front or an endoscopic procedure from the front, in which case the instrument 48 may be inserted from the front of the vertebral body.

The backbone needle assembly 60 includes a probe wire 62 slidably disposed within the needle 64. The assembly 60 typically has, for example, a calibrated diameter No. 18. Other calibrated diameters can and will be used to accommodate suitable guide pins, as will be described in more detail later.

In X-ray, CT, or MRI tracking, the physician moves the assembly 60 through the soft tissue (designated as soft tissue S in Fig. 5A) down to and into the target vertebra 12, as shown in Fig. 5A. Your doctor will usually give you a local anesthetic such as 444 444 444 444 444 444 44

444 44 and lidocaine, through the LQ kit · In some cases, your doctor may prefer to choose another form of anesthesia.

The physician guides the spinal needle assembly 60 to penetrate the lattice bone 32 of the target vertebra 12. Preferably, the penetration depth is from about 60% to about 95% of the vertebral body 26.

Giant. 5A illustrates gaining access to the lattice bone 32 through the stem 42, which is called the transpedicular approach. However, the posterolateral approach, through the side of the vertebral body 26 (referred to as the posterolateral approach PL and shown by the dashed line in Fig. 5A) may be indicated if a compression fracture collapsed the vertebral body 26 below the plane of the stem 42, or otherwise doctor.

After placing the spinal needle assembly 60 into the lattice bone 32, the physician holds the needle 64 and pulls out the probe wire 62 (see FIG. 5B). Still holding the needle 64, the physician pushes the guide pin 66 through the needle 64 up to the lattice bone 32 (see FIG. 5C). The physician will now remove the needle 64 and leave the guide pin 66 inserted inside the lattice bone 32, as shown in Figure 5D.

As shown in Fig. 5E, the physician makes a small incision (designated as χ in Fig. 5E) in the patient's back to locate the trocar 68. The physician introduces the trocar 68 through the soft tissue S along the guide pin 66 down into the shank 42. The physician will insert the distal end 70 of the trocar 68 into the shank 42 to secure its position.

As shown in Fig. 5F, the physician further advances the outer guide shell 72 over the trocar 68. The distal end 74 of the outer guide shell 72 is similarly punctured into stopwatch 42. The physician will remove the trocar 68, leaving the guide pin 66 and the outer guide jacket 72 in place as shown in Figure 5G. Alternatively, the trocar 68 and outer guide shell 72 may be introduced together in one step.

As shown in Fig. 5H, the physician moves the drill bit 76 (e.g., 5 mm in diameter) over the guide pin 66 through the outer guide shell 72. Under X-ray control (or using another external visualization system) the physician guides the drill bit 76 to open the passage 78 through the stem 42 and into the lattice bone 32. The drilled passage 78 preferably extends no more than 95% through the vertebral body 26.

As shown in FIG. 51, the physician will remove the drill bit 76 and the guide pin 66, leaving the outer guide jacket 72 in place. The passage 78 formed by the drill bit 76 remains as it passes through the shank 42 and into the lattice bone 32.

As shown in Figure 5J (1), the physician further advances the catheter tube 50 and the extensible body 56 through the outer guide sheath 72 and into the bore passage 78 in the lattice bone 32. As best shown in Figure 5J (2), it is extensible. the body 56 is maintained in an upright, collapsed state distally beyond the end of the catheter tube 50 during transport through the outer guide shell 72 and into the bore 78 through a rigid outer protective sleeve 73 that surrounds the expandable body 56. Alternatively, it may pass within the expandable body 56 an inner reinforcement element (not shown) for maintaining the expandable body 56 in the desired distally upright state during passage through the outer guide shell 72. Once the expandable body 56 is flflf flflfl flfl flflfl flfl flfl flfl placed on demand At the location within the passage 78, the physician pushes the sleeve 73 back to expose the expandable body 56 The expandable body 56 may be immersed in the thrombin prior to introduction into the vertebral body 26 to promote clotting in place.

The materials for the catheter tube 50 are selected to facilitate the displacement of the expandable body 56 into the lattice bone through the outer sheath 72. The catheter tube 50 may be constructed, for example, using standard, flexible, medical grade plastics such as vinyl, nylon, polyethylene, ionomer, polyurethane and polyethylene terephthalate (PET). The catheter tube 50 may also include more rigid materials to impart greater rigidity, thereby facilitating handling. The stiffer materials that can be used for this purpose include Kevral ™ material

PEBAX ™, stainless steel, nickel-titanium alloys (Nitinol ™) and other metal alloys.

Once the outer protective sleeve 73 is extended, the outer wall 58 of the expandable body 56 is able to assume the expanded geometry within the inner volume 30 (as generally shown in Fig. 5K (1)). To receive expansion of the expandable body 56, the catheter tube 50 includes a first internal cavity 80 (see FIG. 4). This cavity 80 is connected at the proximal end of the catheter tube 50 to a source of pressurized fluid 82. The fluid 82 is preferably radiation impermeable to facilitate visualization. For example, Renograffin ™ may be used for this purpose.

The cavity 80 transports the fluid 82 into an expandable

30 of the body 56 under pressure. As a result, the outer wall 58 expands as shown in FIG. 5K (1). Because fluid ·

* 00 0 0 0 0 0 000 0 0 0 • 0

0 0 0 0 0 is radiopaque, the expansion of the expandable body can be monitored by fluoroscopy or by CT visualization. Using real-time MRI, the expandable body 56 can be filled with sterile water, saline or sugar solution.

Stretching the outer wall 58 enlarges the expandable body 56 and compresses the lattice bone 32 within the inner volume 30. As shown in Fig. 5K (2), the presence of the protective sleeve 73 serves to keep the proximal end of the expandable body 56 away from edge contact with the distal end with the tube 50. catheter.

Compression of the lattice bone 32 creates a cavity 84 in the internal volume 30 of the vertebral body 26. Compression of the lattice bone also exerts an internal force on the cortical bone, allowing to increase or push the broken and compressed bone back to or near its original position before the fracture. Using one transpedicular approach (as shown in Fig. 5K (1)), the cavity 84 occupies approximately one-half of the internal volume 30. As described in more detail later, using multiple approaches, for example one through each stem, a cavity 84 engaging substantially the entire inner volume 30.

As shown in Fig. 4, the proximal end of the catheter tube 50 is preferably connected by conduction to an air vacuum source 86. The vacuum is supplied through the second internal cavity 81 to one or more suction ports 88 at the distal end of the catheter tube 50. Prior to and during stretching of the expandable body 56, suction is applied to remove fat and other tissue through the suction openings 88 for disposal. If »φ« · · ♦ φ * φφφ ·· ·· ► · * 4> · · 4

If desired, a separate suction-irrigation tool may be introduced through the outer guide housing 72 for this purpose.

The expandable body 56 is preferably left inflated for a suitable waiting period, for example three to five minutes, to allow clotting within the vertebral body 26. After this suitable waiting period, the physician folds the expandable body 56 and removes it through the outer guide shell 72 (see FIG. 5L). To facilitate removal, the outer surface of the expandable body 56 may be treated, for example, with an ion beam coating, to reduce friction during passage through the outer guide shell 72. As shown in Fig. 5L, after removal of the expandable body 56, the cavity 84 formed remains in the internal volume 30.

A suction-irrigation tool (not shown) may be introduced through the outer guide housing 72 to further flush and remove dead tissue from the formed cavity 84 after removal of the expandable body 56.

As shown in FIG. 5M, an injection nozzle or spike 90 coupled via the injection tube 92 to the injection gun 94 is inserted into the formed cavity 84 through the outer guide jacket 72. The injection gun 94 carries the filler material 96. The filler material 96 includes, for example, a methyl acrylate sealant or a synthetic bone substitute.

The injection gun 94 may include a putty gun, for example, from Stryker Corporation (Kalamazoo, Michigan). This particular injection gun 94 has a manually operated trigger with a mechanical gain (transmission) of approximately 9 to 1. Other injection guns having larger

Menší * ΒΒΒΒ · · · · · · or less mechanical gain. Non-manually operated injection guns may also be used.

For example, the injection tip 90 may have a diameter of about 4.9 mm to receive a flow of relatively viscous filler material 96 into the cavity 84.

As shown in Fig. 5M, the injection gun 94 pushes the filler material 96 into the cavity 84. While injecting the filler material 96, the physician preferably begins with the injection tip 90 located in the front region of the cavity 84 (as shown in FIG. 5M). The physician gradually advances the tip 90 towards the rear region of the cavity 84 (as shown in Figure 5N) away from the flow of filler material 96 as the material enters and fills the cavity 84. The doctor monitors the injection process through fluoroscopic imaging.

The physician may also control, for example using X-rays, material leakage through the cortical bone 28. Systems and procedures for reducing or preventing such leakage will be described in more detail later.

The physician injects the filler material 96 into the cavity 84 until the filler material reaches the distal end 74 of the outer guide shell 72 (as shown in FIG. 50).

When removing the injection tube 92 from the outer guide shell 72, the physician may stuff, if necessary,

residual padding material 96 from the distal end 74 of the outer guide shell 72 into the cavity 84. If fluoroscopic imaging reveals void areas in the cavity 84, the physician may re-insert the injection tube 92 to add more filler material 96 to the cavity 84.

ftft ftftft * ft · ft ft

Figure 7 shows an alternative technique for filling a cavity. In this technique, the injection tip 90 is disposed within the cavity 84, while the expandable body 56 is folded within the cavity 84. As the expandable body 56 is folded, the injection tip 90 injects the filler material 96 into a portion of the cavity 84 no longer occupied by the expandable body 56. The increasing volume of the cavity 84, which is not occupied by the collapsible expandable body 56, is thus gradually filled with increasing volume. filler material 96. The presence of the expandable body 56, partially expanded when the injection tip 90 injects the filler material 96, serves to compress and distribute the injected filler material 96 within the cavity 84.

As the filling of the cavity 84 proceeds, preferably when viewed by fluoroscopic imaging, the physician gradually pulls the injection tip 90 from the front region of the cavity 84 toward the outer guide shell 72, allowing the filler material 96 to gradually enter and fill the cavity 84 as the expandable body is folded. 56.

Giant. 8A-8C show a preferred embodiment of a tool 650 that integrates an injection tube and an expandable body into a single structure. As shown in FIG. 8B, the instrument 650 includes a catheter tube 652 having a proximal end 654 and a distal end 656. The distal end 656 25 carries an expandable body 662.

As shown in Fig. 8C, catheter tube 652 has a coaxial inner cavity 658 and outer cavity 660, respectively. The inner cavity 658 is connected via a proximal guide 664 to an injection gun 94 of the type previously described. The inner cavity 658 is also connected

4444

444

4 ·

444 with an injection tip or nozzle 666 at the distal end 656 of the catheter tube. The operation of the injection gun 94 serves to eject the filler material 96 through the injection nozzle 666 (as shown in FIG. 8A).

The outer cavity 660 is connected to a pressurized fluid source 80 via a proximal conduit 668. The outer cavity 660 is also connected to the inlets 670 formed at the distal end 656 of the catheter tube below the expandable body 662. The operation of the source 82 serves to inject the pressurized fluid into the expandable body 662 to expand it in the manner described previously ^0. .

As shown in FIG. 8A, the physician introduces the instrument

650 into the lattice bone 32. The physician expands the expandable body 662 to form the cavity 84. Once the cavity 84 is formed, the physician will begin folding the expandable body 662 while injecting the filler material 96 through the injection nozzle 666. The volume of the cavity 84 that is occupied by the folding expandable body 662 is gradually filled with an increasing volume of filler material 96 injected through the injection nozzle. 666.

As described in the foregoing description, the foldable extensible body 662 serves to compress and distribute the filler material 96 more uniformly within the cavity.

84. In fluoroscopic observation, the physician gradually pulls the distal end 656 of the instrument 650 from the front region of the cavity 84 toward the outer guide shell 72, allowing the filler material 96 to enter and fill the cavity 84.

Φ φ «« «« • φ φ φ φ • • •

Upon filling the cavity 84 with filler material 96, the physician will remove the outer guide sheath 72 as shown in Figs. 5P and 50. The cut point is stitched or otherwise closed (as indicated by ST stitching in FIG. 5P).

Gradually, the filler material 96 solidifies to a cured state within the cavity 84 (see FIGS. 5P and 5Q). The solidified filling material 96 provides a renewed internal structural support for cortical bone 28.

The above-described procedure, performed in a minimally invasive manner, can also be performed using an open surgical procedure. Using an open surgical procedure, the physician can reach the treated bone as if the procedure were subcutaneous except that there is no skin and other tissues between the surgeon and the treated bone.

This keeps the cortical bone intact as much as possible and can provide more freedom in accessing the internal volume of the vertebral body.

B. Material Selection for Extensible Body

The material of the outer body wall 58 may be selected according to therapeutic goals limiting its use. For example, materials including vinyl, nylon, polyethylene, ionomer, polyurethane, and polyethylene terephthalate (PET) may be used. The thickness of the outer body wall 58 can typically be in the range of 2/1000 to 25/1000 inches (1 inch is approximately 2.54 cm), or other thicknesses that can withstand pressures up to, for example, 250 to 500 psi (1,725 to 3 inches). 45 MPa).

If desired, the outer wall material 58 may be selected to exhibit generally resilient properties such as latex. Alternatively this material can be chosen *

to exhibit less elastic properties, such as silicone. Using extensible bodies 56 with generally elastic or generally semi-elastic properties, the physician monitors stretching to ensure that there is no excessive stretching and wall failure. In addition, the extensible bodies 56 with generally elastic or generally semi-elastic properties will require some form of external or internal constraint to ensure proper bone insertion.

For example, the extensible bodies 56 with generally ^10% elastic properties will tend to reverse or push into the outer guide shell 72 as they expand. Therefore, it is necessary to internally or externally limit the extensible body 56 that is subjected to this back-up to keep clogged within the inner region

Z E _z . From the bone. In Fig. 6 an outer sealing element 100 is provided for this purpose. In Fig. 6, this sealing element 100 takes the form of a sliding O-ring.

The physician moves this O-ring 100 along the catheter tube 50 within the outer guide sheath 72 using a generally rigid probe wire 102 attached to the O-ring 100.

The physician places the O-ring 100 in or near the distal end 54 of the catheter tube 50 prior to conveying the pressurized fluid 82 to expand the expandable body 56. The O-ring

100 is held in place by a generally rigid 25 probe wire 102 that provides a counter force to prevent the O-ring 100 from shifting back in the outer guide shell 72 as the expandable body 56 expands. The O-ring 100 thereby retains all or a substantial portion a generally elastic extensible body 56 enclosed within the inner volume φ · φ

φ φ

φφφ ΦΦΦΦ

Φ ί ·· φφφ

φφ φ *

30. The expandable body 56 thereby serves to compress as much of the lattice bone 32 as possible.

The use of an outer sealing element 100 to limit the expandable body 56 may not be necessary when relatively non-elastic materials are selected for the expandable body 56. For example, the material for the outer wall 58 of the body 58 may be selected to exhibit more non-elastic properties to limit the expansion of the outer wall 58 over the failure of the wall. The outer body wall 58 may also include one or more restrictive materials, particularly when the outer body wall 58 is itself made of a more elastic material. Constraints made of flexible, non-elastic materials with high tensile strength limit the stretching of the outer wall 58 of the body before the wall fails.

5

Representative examples of generally non-elastic wall structures will be described in more detail below.

C. Selecting the shape and size of the extensible body

As will also be demonstrated later, when relatively non-elastic materials are used for the outer body wall 58, or when the outer body wall 58 is otherwise limited from the outside to limit its expansion before failure, a predetermined shape and size can be provided to the expandable body 56. when it is essentially stretched. The shape and size may be predetermined according to the shape and size of the surrounding cortical bone 28 and adjacent internal structures, or by the size and shape of the cavity 84 required to form in the lattice bone 32.

In one embodiment, which is generally useful for treating bones showing or susceptible to fracture,

• 4 * 4 • 44

the shape and size of the expandable body 56, when substantially expanded, may be designed to occupy at least about 30% of the volume of the lattice bone 32 in the inner volume 30. The expandable body 56 having a substantially expanded size and shape in the range of about 40% to about 99 % of the lattice bone volume is preferred.

In another embodiment, which is useful for treating bones having multiple localized areas caused by fracture or collapse, for example due to avascular Ί necrosis, the shape and size of the expandable bodies 56 may be designed to prevent a smaller volume of lattice bone, for example approximately 10% of this volume. In this embodiment, the bore 78 extends directly into the localized disruption site to allow targeted introduction of the expandable body 56.

The shape of the lattice bone 32 to be compressed and the presence of surrounding local anatomical structures that would be damaged if the cortical bone were displaced inappropriately are generally known to those skilled in the art.

0 medicine using human skeleton anatomy textbooks and their knowledge of the site and its illness or damage. The physician is also able to select the materials and geometries required for the extensible body 56 based on prior analysis of the target bone morphology using, for example, conventional films, tapping of the mandrel, or MRI or CRT imaging. The materials and geometry of the expandable body 56 are selected to form a cavity 84 of desired size and shape in a lattice bone without applying harmful pressure to the outer cortical bone 28 or surrounding anatomical structure 30.

IN

9999 φ «• · · · · O * 9 ·«

9 9 9 · 99

In some cases, when forming the cavity 84, it is desirable to displace or displace the cortical bone 28 to achieve the desired therapeutic result. Such displacement is not in itself detrimental in the sense in which this term is used in this specification, since such displacement is indicated to achieve the desired therapeutic result. By definition, damage occurs when the expansion of the expandable body 56 results in a deterioration of the overall condition of the bone and surrounding anatomical structures, for example by penetrating into the surrounding tissue or causing a permanent adverse change in bone biomechanics.

D. Introducing more extensible bodies

Creating the desired cavity geometry in the lattice bone 32 using the expandable body 56 can be accomplished in a variety of ways to achieve the desired therapeutic effect. The foregoing description envisaged the introduction of one expandable body 56 to compress the lattice bone and to form a cavity 84 having the desired shape and size to receive the filler material 96.

Alternatively, the cavity 84 having the desired shape and size in the lattice bone 32 may be formed by introducing more than one expandable body 56 into the target region of the lattice bone 32, either sequentially or simultaneously.

FIG. 9 shows a representative introduction of a plurality of extensible bodies 56A and 56B through one outer guide shell 72, which is configured to provide a transpedicular approach. It should be quite clear that the introduction of more

Similarly, the extensible bodies 20 may be obtained through an outer guide shell 72 configured to form a posterolateral

Access through the side or side of the vertebral body 26 (as shown as posterolateral access P-L by dashed lines in Figure 9). In Fig. 9, the expandable bodies 56A and 56B are supported by separate catheter tubes 50A and 50B that are not joined together.

In an alternative embodiment shown in Fig. 10, a tool 109 comprising an array 108 of catheter tubes 50A and 50B is used. Each tube 50A and 50B carries the expandable body 56A and 56B, respectively, which are shown in the folded state in Fig. 10. In Fig. 10, the distal ends of the catheter tubes 50A and 50B are connected via a connector 106 for simultaneous insertion through the outer guide sheath 72 into the vertebral body 26 as shown in Fig. 9. As previously described, the sliding slide sleeve 73 extends bodies 56A and 56B during passage through the outer guide skirt 72. Upon withdrawal of this protective sleeve 73, the expansion of the expandable bodies 56A and 56B, either simultaneously or successively, creates a cavity 84. If desired, the connector 106 may allow the catheter tubes 50A and 50B to be aligned relative to each other such that, during insertion, one extensible body is positioned more distally than the other extensible body.

For purposes of illustration, two catheter tubes 50A and 50B are shown in FIGS. 9 and 10B, but of course more than only two catheter tubes may be introduced into the vertebral body 26, either as separate instruments (as shown in FIG. 9). or coupled to form a composite array 108 (as shown in FIG. 10).

In FIG. 10, the extensible bodies 56A and 56B of the array 108 generally have the same geometry when substantially expanded, as shown in FIG.

Fl • fl •

flflfl thereby providing a symmetrical arrangement for compressing the lattice bone 32. This results in a generally symmetrical cavity 84.

Alternatively, as shown in FIG. 11, the expandable bodies 56A and 56B have different geometries when substantially expanded, thereby presenting an asymmetric arrangement for compressing the lattice bone 32. The result is generally an asymmetric cavity 84. By aligning the catheter tubes via the connector 106 (as described above), the distal extent of the expandable bodies may be different from each other, which also results in an asymmetric cavity formation.

The choice of the size and shape of the field 108, whether symmetrical or asymmetric, depends on the size and shape of the target cortical bone 28 and adjacent internal structures, or the size and shape of the cavity 84 required to form the lattice bone 32. The introduction of more extensible bodies 56 makes it possible to create cavities 84 having different and complex geometries within bones of all types. Multiple extensible bodies having generally the same geometry can be introduced in different ways to form cavities with different geometries.

It will be appreciated that the various variants of the more extensible bodies 56, as shown in Figures 9 to 11, are introduced in a distally upright state (as shown in Figures 10 and 11) by use, for example The relatively rigid surrounding protective sleeves 73 (shown in dashed lines in FIG. 10) are handled in the same manner as described with reference to FIGS. 5J (1) and 5J (2). Of course, there are other methods for straightening the expandable bodies 56 for insertion into bone, such as by using internal stiffening elements.

Access to the extensible bodies 56 can be achieved through multiple access points and in many different 5 ways. For example, multiple extensible bodies may enter the vertebral body from different regions of the target vertebra.

Giant. 12 depicts a representative double transpedicular approach in which two outer guide skins 72A and 72B are used to provide a separate approach ¹⁰ for two or more extensible bodies 56A and 56B through different sides of the shank 42A and 42B of the vertebral body 26.

Giant. 13 depicts a representative double-sided posterolateral approach in which two outer guide jackets 72A and 72B are used to provide a separate approach for multiple extensible bodies 56A and 56B from different lateral sides of the vertebral body 26.

When introduced from dual access points, as shown in Figures 12 and 13, from multiple extensible bodies

56A and 56B each form a cavity 84A and 84B (as shown in FIG. 14). These cavities 84A and 84B are transversely separated within the lattice bone 32. Such transversely spaced cavities 84A and 84B may abut to form a single combined cavity (referred to as combined cavity C in Fig. 14) into which the filler material 96 is injected. 15, these transversely spaced cavities 84A and 84B may remain separated by the reticulated bone region (designated the reticulated bone region 110 in Figure 15). In this arrangement, the filler material 96 is then injected into a plurality of individual cavities 84A and 84B within the inner volume.

► 0 0 0 0

0 • 000

As another example, the multiple extensible bodies 56A and 56B may enter the vertebral body 26 from the same general vertebral region. FIG. 16 illustrates a representative dual one-sided posterolateral approach in which two outer guide jackets 72A and 72B are used to form a separate approach from one and the same side of the vertebral body 26.

Upon introduction from these access points (as shown in FIG. 17), the plurality of expandable bodies 56A-Π and 56B form vertically spaced or stacked cavities 84A and 84B. These vertically spaced cavities 84A and 84B may be adjacent to form a single combined cavity (referred to as combined cavity C in Fig. 17) into which the filler material 96 is injected. Alternatively, as shown in Fig. 18, the vertically spaced cavities may be vertically spaced. cavities 84A and 84B separated by a lattice bone region (referred to as lattice bone region 110 in Fig. 18) to form a plurality of individual cavities 84A and 84B within the inner volume each filled with filler material 96A and 96B.

By way of another example, Fig. 19 illustrates a first outer guide shell 72A configured to form a transpedicular approach and a second outer guide shell 72B configured to form a posterolateral approach.

Bone treatment systems using multiple extensible bodies may include instructions 79 (see Figure 12) for introducing the first and second extensible bodies. For example, these guidelines 79 may instruct the physician to introduce them

3q the first extensible body into the internal volume through the first access path through the cortical bone while introducing a second extensible body into the interior volume through the second access path through the cortical bone, wherein the second access path is different from the first access path.

In any of the examples described above, each outer guide shell 72A or 72B may itself receive one or more extensible bodies. The size and shape of the extensible bodies may be the same or may vary according to the physician's desire for the target vertebral body.

¹⁰

E. Representative embodiments of extensible vertebral bodies

i. Compound geometry of toroidal shape

Referring to Figure 20, a representative embodiment 15 of an expandable body, generally referred to as an expandable body 210, is shown. This expandable body 210 comprises a pair of hollow, inflatable, non-extensible portions 212 and 214 of flexible material such as PET or Kevral. The portions 212 and 214 have a suction tube therebetween for draining fat and other tissue by suction into a tube 216 for transfer to a remote disposal site. This catheter tube 216 has one or more suction ports so that suction can be applied to the open end of the tube 216 from a suction source (not shown).

The parts 212 and 214 are joined together by an adhesive, which may be of any suitable type. The portions 212 and 214 have a toroidal shape, as shown in Fig. 20, and have tubes 218 and 220 that are connected to and extend away from the portions 212 and 214, respectively, to the inflation fluid source 30 (not shown). This ·· ···· »9 9

999 • 9 9 • 9 I

99999 99 ·· 99 »> 9 9 • 9 9 · ► 9 9 9 ► 9 9 9 * 9> 9 the fluid extends the extensible body 210 as previously described.

Fig. 21 shows a modified extensible body 280 of the type illustrated in Fig. 20 except that the toroidal shapes of the extensible body 280 are not stitched to each other. In FIG. 21, the extensible body 280 has a pear-shaped convex outer surface 282 that is formed from a first hollow portion 284 and a second hollow portion 285. To guide fluid into the two portions along the branches 290 and 290,

L0 provided a tube 288 for inflating the portions after the portions have been introduced into the inner bone volume. The catheter suction tube 216 may or may not be introduced into the space 296 between two portions of the balloon extensible body 280 to provide flushing or suction. The glue connects two parts

284 and 285 together.

Figure 22 illustrates another representative embodiment of an expandable body, referred to herein as an expandable body 309. This expandable body 309 has a generally circular geometry and three expandable units 310,

312 and 314 of the body. The extensible body units 310, 312 and 314 include spring-loaded outer restraints 317 that limit the expansion of these extensible body units 310, 312 and 314 in a direction transverse to the longitudinal axes of the extensible body units 310, 312 and 314. The constraints 317 25 are made of the same or similar material to that of the expandable body units 310, 312 and 314, so that they have some flexibility but essentially no stretching ability.

Tubes 315 direct fluid under pressure to the expansible body units 310, 312 and 314 for expanding body 9 9999

9 9 • 999 • 9 9 • 9 9

999 ·· 99 • 9 9 9

9 9 9

9 of these expandable body units 310, 312 and 314 and cause compression of the lattice bone. The constraints 317 limit the expansion of the extensible body units 310, 312 and 314 before failure, while keeping opposite sides 377 and 379 substantially flat and parallel to each other.

ii. Compound geometry of bean shape

FIG. 23 shows another representative embodiment of the extensible body 230 having bean-shaped geometry. The extensible body 230 has a pair of opposing bean-shaped side walls 232 and a continuous end wall 234. A tube 238 conducts fluid to the extensible body 230 to expand it within the vertebral body.

FIG. 24 shows another representative embodiment of the expandable body 242, which also has bean-shaped geometry. This extensible body 242 is initially a single-chamber bladder, but the bladder is fired along curved lines or lines 241 to form attachment lines 244 having the shape of side-by-side bean-shaped compartments 246 as shown in Figure 25. Lines such as an extensible body 242, but with straight lines, would be applied to a body that is square or rectangular. Firing causes two sides of the bladder to be welded.

Details of these and other extensible bodies useful for treating vertebral bodies are described in U.S. Patent Application Serial No. 08 / 188,244, filed Jan. 26, 1994 and incorporated herein by reference.

·· ···· · · • flflfl flfl flflfl fl • flflfl • fl • fl • flfl fl · fl fll flfl flfl flfl

F. Select the desired geometry

The eventual choice of size and shape of a particular extensible body or extensible bodies to treat the vertebral target body 26 is based on several factors, c.

When multiple extensible bodies are used, the overall combined dimensions of all introduced extensible bodies should be taken into account when substantially expanded.

The front-rear (AP) dimension (see FIG. 26) for the extensible body or extensible bodies is selected from CT ¹⁰ images or plain film or from X-ray imaging of the vertebrate target body 26. The AP dimension is measured from the inner cortical wall of the anterior surface layer to the inner cortical wall of the posterior surface layer of the vertebral body. It is generally suitable

A-P dimension for an extensible body or extensible bodies smaller than this anatomical dimension.

A suitable lateral dimension L (see FIG. 26) for the extensible body or extensible bodies is also selected from CT images or plain film or X-ray scanning of the vertebral target body 26. This distance between the sides is measured between the inner cortical walls through the target vertebra body. Generally, a suitable lateral dimension L for the extensible body or extensible bodies is also smaller than this anatomical dimension.

The lumbar vertebral body tends to be much wider in the L side dimension than in the A-P dimension. For thoracic vertebral bodies, the lateral dimension L is almost identical to the A-P dimension.

The height dimension H of the expandable body (s) (see Fig. 26) is selected by

CT or X-ray imaging of vertebral bodies above and above 9 99 • e ···

9 9

9 9

9 9

9 · ·· below the vertebral body to be treated. The height of the vertebral bodies above and below the vertebral body to be treated is measured and then averaged. This diameter is then used to determine a suitable height dimension for the selected extensible body.

The dimensions of the extensible or vertebrate body are patient-specific and will vary over a very wide range, as summarized in the following table:

10 Type Height (H) Front-rear Lateral (L) vertebrae dimension (A-P) dimension dimension typical typical typical extensible extensible extensible 15 Dec or or or extensible extensible extensible bodies bodies bodies Lumbar 0,5 cm to 0,5 cm to 0,5 cm to 4,0 cm 4,0 cm 5,0 cm 20 May Thoracic 0,5 cm and w 0,5 cm to 0,5 cm to 3,5 cm 3,5 cm 4,0 cm

A preferred extensible body 56 for use in a vertebral body is stacked with two or more extensible elements of unequal height (see Figure 26), wherein each element can be inflated separately through independent tubular systems.

The total stack height when fully inflated should be within the height ranges specified above. Such a design allows the fractured vertebral body to return to its original height in steps, which may be easier for 30 surrounding tissue, and also allows the same balloon (expandable body) to be used over a wider range of vertebral body sizes.

II. Treatment of long bones

Similar to the vertebrae, the inner regions of the 5 long bones that are substantially occupied by the lattice bone can be treated using one or more extensible bodies. Figure 43 shows representative regions of the human skeleton 600 in which the regions of the lattice bones can be treated using extensible bodies. These regions include the distal radius (region 602); the proximal tibia plateau (region 604); proximal humerus (region 6Q6); the proximal femoral head (region 608); and calcaneus (region 610).

As for vertebral bodies, extensible bodies have the important property of being able to lift or push the broken or compressed cortical bone back to or near its normal anatomic position during cavity formation by compressing the lattice bone. This is especially so

An important feature for the successful treatment of compression or lattice fractures in an appendicular skeleton such as the distal radius, the proximal humerus, the tibia, the femoral head, the hip, and the heel.

Representative examples of extensible bodies for treating the lattice regions of long bones will be described in the following description.

A. Extensible body for distal radius

Selection of a suitable extensible body for the treatment of the distal spindle bone fracture (area 602 in Fig. 43) · · · oblast oblast oblast oblast oblast oblast oblast oblast oblast oblast oblast oblast oblast oblast oblast oblast oblast ·········· Depending on the radiologically measured size of the distal radius of the radius and the fracture position.

27 and 28 show a representative extensible body 260 for use in the distal spindle bone. This extensible body 260, shown to be inserted into the distal spindle bone 252, has a shape that resembles a pyramid, but most closely resembles a banana with a bump. The geometry of the expandable body 260 substantially fills the interior of the distal spindle bone space to compress the lattice bone 254 against the inner surface 256 of the cortical bone 258.

The extensible body 260 has a lower, conical portion 259 that extends downwardly into the hollow space of the distal spindle bone 252. This conical portion 259 increases in cross section ¹⁵ as it approaches the central distal portion 261. The cross-section of the extensible body 260 is shown at a central location (see FIGS. 27 and 28) adjacent the widest point of the extensible body 260. The upper end of the extensible body 260, designated upper end 262, converges into the catheter tube 288 to guide fluid to the extensible body 60 for its extension. stretching and also for pushing the lattice bone against the inner surface of the cortical bone.

The shape of the extensible body 260 is determined and limited by tufts formed by spring constraints 265. These constraints 265 are optional and provide additional strength to the extensible body 260, but are not required to achieve the desired configuration.

The extensible body 260 is inserted into and removed from the distal spindle bone in the same manner as described in connection with the vertebral bone.

Typical distal spindle bone dimensions vary ⁵ as follows:

The proximal end of the extensible body 260 (i.e., the part closest to the elbow) has a cylindrical shape and will have different dimensions ranging from 0.4 x 0.4 cm to 1.8 x 1.8 cm.

2_q The length of the body of the distal radius will vary from 1.0 cm to 12.0 cm.

The widest dimension from the center to the body side of the distal radius, located at or near the joint of the distal radius and elbow, will be in the range of 0.5 cm to 2.5 cm.

The distal anterior-posterior dimension of the body of the distal radius will vary from 0.4 to 3.0 cm.

B. Extensible body for fracture of humerus

The choice of a suitable extensible body 266 for treating a given fracture of the proximal humerus (region 606 in Fig. 43) depends on the radiologically measured size of the proximal humerus and the location of the fracture.

Figure 29A shows a representative embodiment of the expandable body 266 for use in the proximal humerus 269. The expandable body 266 is spherical to compress the lattice bone 268 in the proximal humerus 269. If the surrounding cortical bone has been damaged by a compression fracture, stretching the expandable body 266 also serves for

lifting or shifting the broken cortical bone back to or near its anatomical position prior to fracture.

The mesh 270, recessed or layered and / or coiled, may be used to form a constriction 272 on the expandable body 266. The second mesh 272a may be used to match the bottom of the body bottom 272a to the shape of the inner cortical wall at the beginning of the bone shaft. These mesh constraints provide additional strength to the expandable body 266, but the arrangement can be achieved by molding the body.

The expandable body 266 has a catheter tube 277 into which fluid is pressurized into the body to expand and compress the lattice bone in the proximal humerus. The extensible body 266 is inserted into and removed from the proximal humerus in the same manner as described above in connection with the vertebral bone.

Typical dimensions of the expandable body 266 shown in Figure 29A for a proximal arm fracture. bones are changed as follows:

The spherical end of the expandable body will vary from 0.6 x 0.6 cm to 3.0 x 3.0 cm.

The taper of the expandable body for the proximal humerus fracture will vary from 0.5 x 0.5 cm to 3.0 x 3.0 cm.

The width of the lower or distal portion of the expandable body for proximal humerus fracture will vary from 0.5 x 0.5 cm to 2.5 x 2.5 cm.

The length of the extensible body will vary from 3.0 cm to 14.0 cm.

Giant. 29B depicts another representative embodiment of the extensible body 266 'for use in the proximal humerus. Instead of being conical, the expandable body 266 ^of Figure 29B has a generally cylindrical geometry to compress the lattice bone 268 in the proximal humerus 269.

Alternatively, the cylindrical expandable body 266 'may be elongated to create elliptical geometry or geometry in the

Tvaru 'shaped ball for American football. Typical dimensions of a cylindrical or elliptical expandable body vary in the range of from 0.6 cm to 3.0 cm in diameter and in the range of from 3.0 cm to 14.0 cm in length.

C. Extensible body for fracture of the proximal tibia plate

The choice of the extensible tibia fracture treatment body (region 604 in Fig. 43) will depend on the radiologically measured size of the proximal tibia and

2Q on fracture placement.

Fig. 30A shows a representative extensible body 280 for treating a fracture of the tibia. The extensible body 280 may be inserted into the tibia from any direction as desired by a physician, for example, from above, or from a central, lateral, anterior, posterior, or inclined approach. In Fig. 30A, the extensible body 280 has been inserted into the lattice bone 284 from the front of the tibia 283 and is shown positioned on one side 282 of the tibia 283.

• 0 · 00 0000 00 00

000 0 0 00 0 · 0 ·

0 00000 000 ·

000 000 000 000 0

00 0000

000 0000 00 000 0 · 00

The extensible body 280, when substantially expanded or inflated (as shown in Figure 30A), compresses the lattice bone 284 in the layer surrounding the extensible body 280. If the tibia plate has been subjected to a compression fracture, stretching the extensible body 280 also serves to displace the plate the tibia back or near its original anatomical position prior to fracture as shown in FIG. 30A. In this way, fractures on both the middle and lateral sides of the tibia can be treated.

As shown in FIG. 30B, the extensible body 280 has a pair of opposing sides 285 and 287. Sides 285 and 287 are connected to each other by constraints 288 that extend through the extensible body 280. In FIG. 30C, cut ends 291 of constraints 288 are shown. .

The limitations 288 may be in the form of springs or flexible elements of any suitable design. Restrictions 288 limit the expansion of the extensible body 280 before failure. The constraints 288 cause the sides 285 and 287, when the expandable body 280 is substantially expanded, to be substantially parallel to each other and thereby the body is not spherical.

Connected to the expandable body 280 is a tube 290 for conducting fluid into and out of the body for expanding it.

The extensible body is inserted and removed from the tibia in the same manner as described above in connection with the vertebral bone. FIG. 30C shows a substantially circular configuration of the expandable body 280, although the expandable member 280 may also be substantially elliptical, as ^te shown in FIG. 31.

• 99

9 9 9 9 9

9 9 9 999 9 9 9 9 • · · · ···········

999 99 99 99 99 99

Other geometries and other configurations may also be used. For example, as shown in Fig. 32, two or more extensible bodies 280 (1), 280 (2) and 280 (3) may be stacked on top of each other to create a different cavity geometry and to improve the plateau fracture displacement. The plurality of expandable bodies 280 (1), 280 (2) and 280 (3) may comprise separate units or may be joined together for co-introduction. When used as a single unit, these expandable bodies 280 (1), 280 (2) and 280 (3) can enter through the same access point or from different access points.

As another example, Figure 33 illustrates that the extensible body 280 'may assume an egg shape when substantially expanded or inflated to form a cavity and

Ί C, reshaping of broken bones. Other geometries, such as cylindrical or spherical, can also be used for the same purpose.

Typical dimensions of the expandable body 280 for treating the fracture of the proximal tibia plateau vary as follows:

The thickness or height of the expandable body will vary from 0.3 cm to 5.0 cm.

The front-rear (front to back) dimension will vary in

range from From 1.0 cm to 6.0 cm. Wednesday ke hand the (lateral) dimension will be change range from 1,0 cm to 6,0 cm. On Fig. 44 and Fig. 45 more is shown of extensible zones 614 and 616 introduced into the lattice bones

620. One extensible zone 614 serves as a platform for limiting and directing the expansion of the second extensible zone 616.

• ··· 444444 ·· ·· · · · 4 4 4

4,4444,444 * 4,444,444

4 * 4 4444 44 4 * 4 4

For purposes of illustration, Figures 44 and 45 illustrate the use of these multiple extensible zones 614 and 616 for this purpose for treating fracture 622 of the tibia.

In the embodiment shown in Figures 44 and 45, the extensible zones 614 and 616 include a separate extensible body. However, it should be understood that these extensible zones 614 and 616 may include portions of one extensible body.

In this illustrated embodiment (as shown in Figure 44), the first extensible zone 614 is introduced through the first outer guide shell 618 (1) into the lattice bone 620 below the fracture 622. As shown in Figure 44, when substantially expanded, the first extensible zone extends

614 more along its horizontal axis 624 (i.e., in the side direction) than along its vertical axis 626 (i.e., in the top-down direction 15). The larger extended lateral geometry of the first extensible zone 614 compresses the lattice bone in a relatively thin region that extends substantially over the internal volume 628 occupied by the first extensible zone 614. The geometric boundaries of the extensible zone 614 will usually fall just inside the inner cortical walls of the proximal tibia. any other bone into which the first extensible zone 614 is introduced.

The expanded first extensible zone 614 forms a barrier 25 630 within the inner volume 628. Due to the less expanded geometry in the top-down direction of the first extensible zone 614, a substantially uncompressed lattice region 632 that extends from the formed barrier 630 is left on the extensible zone 614. in the upward direction to fracture 622.

With a representative introduction, this uncompressed region 632 · 32 · · · ♦ ·

It extends approximately 2 cm below the fracture 622 of the tibia plate.

As shown in Fig. 44, the second extensible zone 616 is introduced through the second outer guide jacket 618 (2) into the uncompressed area 632 left between the first extensible zone 614 when substantially expanded and the fracture 622 of the target tibia plate.

As shown in Fig. 45, the second extensible zone 616 has a geometry substantially the same as that of the bodies shown in Figs. 30A-30C. When substantially expanded or inflated, this second expandable zone 616 compresses a large percentage of the lattice bone in the uncompressed region 632 above the first expandable zone 614. The presence of the barrier 630 formed by the expanded first expandable zone 614 (see also FIG. 46) prevents extending the second extensible zone 616 away from the fracture 622 of the tibia plate. Instead, the barrier 630 directs the expansion of the second extensible zone 616 towards the fracture 622. Supported by the barrier 630, the expansion of the second extensible zone 616 is directed against the fracture 622 and restores the normal anatomical position in this portion of the bone as shown in FIGS. 46.

It should be understood that one or more expandable bodies or zones may be used as platforms or barriers to direct the stretching of one or more additional expandable bodies or zones in other localized inner bone regions. The barrier allows localized cavity formation in the inner bone regions. The use of a barrier protects healthy areas of the lattice bone while directing the main compressive expandable body toward

9 9 99 9 • 99

9 9 9 9 9 9 9 9

9 9

9 9

999

9 9 ·

9 9 9

9 9φ 9

9 9 9

99 localized fractures or localized areas of diseased lattice bone.

D. Extensible body for femoral head

The size of the extensible body for use in the femoral head (region 608 in Fig. 43) is selected based on the radiologically measured size or size determined by CT scanning the femoral head and the location and size of the avascular necrosis in the bone.

FIG. 34 shows a representative embodiment of the extensible body 300 inserted into the interior of the femoral head cortical bone 302. As shown in FIG. 34, the femoral head is thin at the outer end 304 of the femur and increases in thickness towards the lower end 306 of the femur. Tube 309 conducts fluid to expand the expandable body 300. Tube 309 extends along the narrowing of the femur and into the femoral head. The extensible body 300 compresses the lattice bone 307 in this

2q of the bone region, also shifting the broken cortical bone back to or near its normal anatomical position.

The femoral head has a generally spherical configuration and the expandable body 300 may have either a hemispherical (see FIG.

35) or also spherical (as shown in FIG. 34) geometry. The hemispherical shape is maintained in Fig. 34 by joining the overlapping portions of the expandable body 300, creating folds 300b.

·· ··· «·· ♦ ·

The extensible body 300 is inserted into and removed from the femur head in the same manner as described in connection with the vertebral bone.

The usual dimensions of the expandable body for use in treating the femoral head are varied as follows:

The diameter of the expandable body will vary from 0.5 cm to 4.5 cm. The dimensions of the hemispherical body (see Fig. 35) are the same as those of the spherical body (see Fig. 34) except that approximately one half of the entire body is formed.

E Extensible body to prevent hip fracture

Patients with hip bone density (area 612 in Fig. 43) below the threshold are at increased risk of hip fracture, with lower densities posing a greater risk. Patient selection is done by scanning bone density.

Fig. 36A illustrates a representative embodiment of an expandable body 410 having boomerang-like geometry for use in preventing a hip fracture. When substantially expanded (as shown in Fig. 36A), the expandable body 410 forms a cylinder that gradually bends in the middle, similar to a boomerang, and extends from approximately 0.5 cm from the end of the femur head 411 through the femoral narrowing 412 bone and down into the proximal diaphysis 413 of the femur approximately 5 to 7 cm behind the smaller trochanter 414.

The expansion of the expandable body 410 is limited to achieve the described geometry by rings 430 of non-elastic material. Rings 430 are held in ·· * «« ·

4 · ··

4 4 ·

4 9 ·

4 4 4

9 4 4

44 • 44 • 4

944 4444 • 4

4 44 4

9 9 4

9 9

449 a spaced apart relationship along one side of the extensible body 410 through attachment to a non-elastic waistband 416 that extends below the length of that side of the extensible body 410. The rings 430 are held in a spaced more spaced relationship along the opposite side of the extensible body 410 through attachment to another, longer a non-elastic strip 417 that extends along the length of the opposite side of the expandable body 410. The tube 419 transports fluid to expand or not to blow the expandable body 410.

Prior to introduction into the bone body, the extensible body is folded and rolled and held relative to the inflatable tube 419 using, for example, easily breakable couplings that break when the body is subjected to ic _in stretching. To introduce the extensible body 410 into the hip, the surgeon uses a machine drill under radiographic (x-ray) guidance to form a cavity 420 that is, for example, approximately 4 to 6 mm wide and begins at the lateral surface layer 421 of the femur and proceeds to the head

O Q

Femur 411. The extensible body 410 is introduced through the guiding sheath 423, following the cavity 420. The extensible body 410 is introduced, prior to stretching, towards the smaller trochanter 414 so that the stretching extends towards the femoral diaphysis 413 and not towards the larger trochanter region 422. 25

The expansion of the expandable body 410 is conducted by rings 430 and belts 416 and 417 which cause the expandable body 410 to bend downwardly into the region of the smaller trochanter 414. Alternatively, a second cavity may be drilled into the shaft 413 starting from the same inlet 30 or from the other .

φ φ φ φ φ φ · · · »» »• • • • • • • φ φ φ φ • φ φ φ · φ φ φ φ φ φ φ φ φ

The length of the extensible body is selected by the physician to extend approximately 0.5 cm from the end of the femur head, through the narrowing of the femur and into the proximal femoral shaft, usually approximately 4 to 8 cm below the smaller trochanter. The diameter of the extensible body 410 is selected by measuring the inner diameter of the cortical bone in the narrowing of the femur (which is the narrowest region) and subtracting 0.5 cm. Preferred dimensions of the expandable body 410 are: overall length in the range of from 10 to 20 cm and diameter in the range of from about 1.0 to 2.5 cm.

Patients having the lowest bone densities in the femoral head may require more densification in this femur head, which may, for example, be accomplished by using two extensible bodies, one by ^{15 each} : where the bent extensible body 410 is followed by the femoral head body ( placed in the same place and stretched before loading any carrier material).

Alternatively, the bent extensible body 410 may be adapted to have a distal portion that approximates the body shape of the n femoral head.

The geometry of one limited extensible body 410 can be achieved by a plurality of extensible bodies introduced separately, or joined together, or stacked together. Fig. 36B shows a representative embodiment utilizing a plurality of extensible bodies in the hip region.

As shown in Fig. 36B, the first extensible body 410 (1) is introduced through the first outer guiding sheath 423 (1) in the proximal lateral surface layer of the femur shaft.

Φ φ φ φ φ * «« φ ΦΦΦΦ ΦΦΦΦ ΦΦΦΦ ΦΦΦΦ ΦΦΦΦ ΦΦΦΦ ΦΦΦΦ φ · φ φ φ φ φ φ φ φ φ φ φ φ φ φ φ φ φ

This first extensible body 410 (1) is inserted through the tapered femur 480 into the femur head 482.

A second extensible body 410 (2) is introduced through the second outer guiding sheath 423 (2) in the region 422 of the greater trochanter of the femur. This second extensible body 410 (2) is introduced in the direction of the femoral shaft 413.

Other approaches may be used. For example, one extensible body may be introduced through the femoral neck 480 and the other extensible body may be inserted along the femur shaft.

One or both of the extensible bodies 410 (1) and 410 (2) may include an external constraint to limit stretching in the same manner as described in connection with the extensible body 410. Stretching of the extensible bodies 410 (1) and 410 (2) compresses the lattice bone to form cavities having geometry approaching geometry formed by one extensible body 410.

F. Extensible body for fracture of calcaneus, ..

The size of the extensible body for use in treating the heel fracture (heel) (region 610 in Fig. 43) is selected based on radiological size measurement or CT measurement of the heel and fracture position and size.

37A and 37B show a representative expandable body 450 for treating the heel bone fracture 452. Tube 464 transports fluid to the expandable body 450 to expand it.

ΒΒΒ Β · · • • • • • • • • • • · · · · · · · · · · · · ·

Β ΒΒ Β · Β Β Β

ΒΒ ΒΒΒΒ ΒΒ ΒΒΒ ΒΒ ΒΒ

In Fig. 37Α, the extensible body 450 is inserted into the heel bone 452 through the posterior access, through the heel bump. A different approach may be used as required by the physician. The machine drill opens the passage 466 through the heel bump into the heel bone. The outer sheath 470 is positioned within this passageway 466 and is supported on the back of the calcaneus in the manner already described in accessing the vertebral body. The extensible body 450 is introduced through the outer guide shell 470 and the formed passage 466 into the heel bone.

Stretching of the expandable body 450 is limited within the heel bone boundaries by non-elastic peripheral strips 454 (see FIG. 37B). These belts 454 limit the stretching of the expandable body 450 to the asymmetric pear-shaped geometry, best shown in FIG.

37B. This pear-shaped geometry has a major dimension H1 occupying the rear surface area 454. The major dimension H1 is located here because the portion of the calcaneus that most likely will require lifting and re-alignment

Γ) during stretching of the expandable body 450, the right compressed portion of the posterior surface 454 is the heel bone, where the posterior surface 454 is adjacent to the ankle bone 456.

The pear-shaped geometry has a smaller, minor dimension occupying an area of the anterior surface 458 of the heel near the heel joint 460 and the cubic bone between the heel bone and cubic bone 462.

Stretching of the expandable body 410 compresses the lattice bone 470 within the heel bone 452. This stretching

30 also lifts the compression fracture of the posterior surface 454 back to or near its original anatomical location at the posterior surface

4444 44 94

9 4 4 9 4

9 9,999 9 4 4 4

9 4 4 9 * 99

9 9 9 9 9 9

9999 99 999 99 99 in close proximity to the ankle bone 456. When folded and removed, the expandable body 410 leaves a cavity in a lattice bone into which the cushioning material can be fed in the manner described previously.

c _z

Figure 38 illustrates another representative embodiment of the expandable body 450 'for use in treating fractures in the calcaneus. This expandable body 450 ^of Fig. 38 has a geometry more spherical or ovoid than the expandable pear-shaped body 450 shown in Fig. 37B. Like the pear-shaped expandable body 450, the expandable body 450 ^z , when expanded within the calcaneus, creates a cavity within the calcaneus and re-aligns the fractured cortical bone to or near its normal anatomical position.

III. Choice of other extensible bodies (further overview)

Various sizes and / or shapes of extensible bodies may be used in locations not specified above, such as jaws, middle stem parts of the arms and legs, cervical vertebrae, foot and ankle bones, pelvis, ribs and the like.

The choice of shape and size of the extensible body takes into account the morphology and geometry of the site to be treated.

as mentioned above, the shape of the lattice bone to be compressed and the local structures that could be damaged if the bone were displaced inappropriately are part of the general knowledge of medical practitioners and the use of human body anatomy textbooks together with knowledge of the site and illness or damage to this place. Exact dimensions for ftft ftft ftftft * ·· · ftft • ftft ftftft ··· ft ftftft ftftft · ftft ft «ftft ·· ······ • ft ftft ftft ··· ftftft ftft ·· ftft ftftft ftft ftft a given patient can be further determined by X-ray imaging of the site to be treated.

As one general guideline, the choice of the expandable body geometry should take into account that at least 40% of the lattice bone volume must be compressed in cases where the bone disease causing the fracture (or the risk of such a fracture) is loss of lattice mass ( as in osteoporosis). A preferred range is from about 30% to 90% of the lattice bone volume. Compressing a smaller volume of lattice-Ω bone may leave too much of the diseased lattice bone at the treatment site. Diseased lattice bone remains weak and may collapse later, causing a fracture, regardless of treatment.

Another general guide for selecting the expandable body geometry 15 is the extent to which the target fractured bone region has been displaced or compressed. Stretching the body within the lattice bone can lift or push the broken cortical wall back to or near its original anatomical position occupied before the fracture has occurred.

There are, however, moments at which less compression of the lattice bone is indicated. For example, when the disease is localized to the treated bone, such as avascular necrosis, or where local loss of blood supply damages the bone in a limited area, the expandable body may compress a smaller volume. This is because the disease area requiring treatment is smaller.

Another exception is the use of an expandable body to improve the introduction of rigid materials of defined shapes such as hydroxyapatite and components in full replacement

···· • flflfl • fl flfl • flfl · flfl · flfl * fl · fl • fl flfl joints. In these cases, the shape and size of the body are defined by the shape and size of the material being introduced.

Yet another exception is the administration of therapeutic substances, which will be described in more detail below. In this case, the malignity of the male bone may not be ill or adversely affected. A healthy lattice bone can be sacrificed under considerable compression to improve the administration of a drug or growth factor that has an important therapeutic purpose.

In this application, the size of the expandable body is selected according to the desired amount of therapeutic substance to be administered. In this case, the bone with the medicament is carried inside while the medicament acts, and the bone is healed through an external plaster bandage or internal or external fixation devices.

Generally speaking, providing the relatively non-elastic properties of the extensible body, although not always required, is nevertheless advantageous to maintain the desired shape and size within the bone, for example when placing bone transplants or in the vertebral body where the spinal cord is near. Using relatively non-elastic extensible bodies, the shape and size can be better predefined taking into account the usual dimensions of the outer edge of the lattice bone. The use of relatively non-elastic also more reliably allows applying pressures equally in all directions to compress the lattice bone. Moreover, still substantially equivalent results can be achieved by using more extensible bodies having highly elastic properties when the stretching is controlled by either internal or external constraints, as described in the foregoing description.

9 · · 9 9999 9 · ·· · 9 999 9999

9 9 9 9 9 9 9 9

999 9 999 99

98 9 9 9 9 9

999 9999 99 999 99 · »

IV. Optimal orientation in asymmetric constructions

A. Common symmetrical constructions

Fig. 50 shows a tool 848 that includes 5 catheter tube 850 having a proximal end 852 and a distal end 854. The catheter tube 850 includes a handle 851 to facilitate grip and maneuver with the catheter tube 850. The handle 851 is preferably made of foam material secured around the catheter tube 850.

The distal end 854 carries an expandable structure 856, which is shown in Fig. 51 as a conventional structure used, for example, for insertion into veins and arteries, for example, in angioplastic applications. The extensible structure 856 is shown in Figure 50 in substantially composite geometry. This extensible structure 856 typically includes an elongate tube formed, for example, by standard polymer extrusion and forming processes. The tubular expandable structure 856 is connected at its opposite ends 858 to the catheter tube 850 using, for example, an adhesive. When substantially folded, this extensible structure 856 may be introduced into the inner region of the body.

FIG. 51 is an enlarged view of the expandable structure 856 when the geometry is substantially expanded. As shown in FIG. 51, the intermediate region

864, the tubular extensible structure 856, when substantially expanded, assumes a generally cylindrical shape that is symmetrical about the major axis 860 of the catheter tube 850. Stretching stretches the polymeric material of the expandable structure 856 in proximity • 56 * * * Φ Φ Φ

9 9 9 9 9

9,999 9 9 9 9

9 9 9 9 9 9

9 9 9 9 9

999 99 99 of its connected opposite ends 858 to form generally conical end portions 862.

When the extensible structure 856 is inserted into the bone as described in the above-mentioned U.S. Patent Nos. 4,969,888 and 5,108,404, the access gate 843 (see Figures 52 and 53) extends downwardly toward the bottom of the vertebral body 826 to enter 52 and 53, this access gate 843 aligns the major axis 860 of the catheter tube 850 at an angle relative to all natural axes 866, 867, or 69 of the vertebral body 826.

As the conventional extensible structure 856 expands within the internal volume 830 (as shown in Figs. 54 and 55 in a side view and in a side view, respectively), the extensible structure 856 extends symmetrically about the catheter tube main axis 860 while compressing the lattice bone 832. However, since this major axis 860 of the catheter tube is oriented obliquely with respect to all natural axes 866, 867 or 869, the formed cavity 868 is not centered relative to the middle region of the MR. Instead, the cavity 868 is displaced to one side of this intermediate region MR (as shown in FIG. 55) and also extends from top to bottom at an oblique angle over this intermediate region MR (as shown in FIG. 54).

Due to these asymmetries, the cavity 868 will not provide optimal support for the middle region of the MR when filled with bone mastic. Because the volume of bone sealant is not centered around the middle region, the ability of the body 826 to withstand the load is limited. The asymmetric compression of the lattice bone 832 in the internal volume 830 may also exert unequal or inconsistent internal forces on the cortical bone 832, 9 9 9.99 * 9 · 9 · 9 9 ·

I · · t · 9 9 9 ø · 9 9 9 9 9

999 99 99 which then makes it difficult to pick up or push the broken or extruded bone.

B. Optimal orientation for compression of lattice bone

Fig. 56A illustrates an improved bone treatment tool 814 that includes a catheter tube 816 carrying an expandable structure 820 at its distal end 818. The catheter tube 816 may, at its proximal end, be arranged similarly to the catheter tube 850 shown in FIG. 50, with a handle 851 made, for example, of a foam material.

Fig. 56A illustrates the extensible structure 820 in a substantially expanded state, wherein the structure comprises a cylinder 821 with generally conical portions 834, each having a top 825 and a bottom 827. The tops 825 of the conical portions 834 are secured around the catheter tube 816; in this sense, they are generally aligned with the catheter tube axis 824. In contrast to the expandable structure 856 shown in FIG. 51, however, the major axis 822 of the cylinder 821 is not aligned with the axis 824 of the catheter tube 816. Instead, the major cylinder axis 822 is offset at an angle θ from the catheter tube axis 824. As a result, the extensible structure 820, when substantially expanded (as shown in Fig. 56A), is not symmetrical with respect to the catheter tube axis 824.

In Fig. 56A, the bottoms 827 of the conical portions 834 extend generally perpendicular to the major axis 822 of the cylinder. In this orientation, the tops 825 and the bases 827 are not parallel to each other. Of course, other orientations are possible. For example, in FIG. 56B, the bottoms 827 of the conical portions 834 extend at the bottom

0 0 0

V 0 0

0000 substantially perpendicular to the catheter tube axis 824. In this orientation, the tops 825 and the bases 827 are generally parallel to each other.

Fig. 57 is a side elevational view of the displaced extensible structure 820 illustrated in Fig. 56A introduced into the internal volume 830 of the vertebral body 826. As previously shown in Figures 54 and 55, the approach illustrated in Figure 57 does not align the catheter tube axis 824 with any of the natural axes 866, 867 and 869 of the vertebral body 826. However, as shown in Fig. 57, stretching of the displaced cylinder 821 of the extensible structure 820 about the major axis 822 is not symmetrical with respect to the catheter tube axis 824. Instead, the stretching of this displaced extensible structure 820 is generally aligned with the natural axes 866 and 869 of the vertebral body 826. As shown in Fig. 57, one displaced extensible structure 820 may form a cavity 838 that, although still laterally displaced to one side of the middle region MR (as shown in Fig. 55), is nevertheless symmetrical from top to bottom relative to to the middle MR area. The mating, adjacent cavity may be formed by introducing a second displaced extensible structure 820 on the opposite side of the vertebral body 826. This composite cavity, formed by two displaced extensible structures 820 or bodies, introduced simultaneously or sequentially by a dual approach, is substantially centered in all directions around the middle region of the MR.

The cavity, centered relative to the middle region of the MR, provides support uniformly across this middle region of the MR when filled with bone mastic. The ability of the vertebral body 826 to withstand loads is thereby improved. Symmetrical compression

0000

0 0

0 000

0 9

0 0 ·· 900

00

0 0

000 0000

00

0 0 0

0 0 9

0 9 9 0

The lattice bone 832 in the internal volume 830, which the centered cavity also provides, also exerts much more equal and uniform internal forces on the cortical bone 842 to lift or push the broken or extruded bone.

Figures 58A and 58B illustrate the extensible structure 1200 having displaced, asymmetric geometry other than the geometry of the displaced extensible structure 820 shown in Figs. 56A and 56B. In Figs. 56A and 56B, the displacement angle mezi between the major axis 822 of the cylinder and the axis 824 of the catheter tube is an acute angle. As a result, the major axis 822 of the expandable structure 822 is displaced in a non-parallel dimension or plane relative to the catheter tube axis 824. In Figs. 58A and 58B, the displacement angle A between the cylinder axis 1220 is zero for the catheter tube axis 1240 because the cylinder axis 1220 is zero.

1210 is offset from and in a generally parallel dimension or plane relative to the catheter tube axis 1240. The catheter tube 1160 may be arranged at its proximal end similar to the tube 850 shown in FIG. 50, with a handle 851 made, for example, of a foam material.

As shown in Figures 58A and 58B, there are tops

The 1250 conical portions 1340 are secured around the catheter tube 1160 and in this sense are generally aligned with the catheter tube axis 1240. In Fig. 58A, the bottoms 1270 of the conical portions

1340, they are generally perpendicular to the axis 1240 of the catheter tube 25 and hence are generally parallel to the tops 1250 (comparable to the orientation shown in FIG. 56B). In Fig. 58B, the bottoms 1270 of the conical portions 1340 extend at an angle B relative to the catheter tube axis 1240. In this orientation, the tops 1250 and the bases 1270 are not parallel to each other.

ΊΟ

Giant. Figs. 56A, 56Β, 58A, and 58B illustrate that by adjusting the displacement angle a as well as by adjusting the orientation of the bottoms of the conical end portions, substantially any desired displaced geometry can be achieved and thereby conform the orientation of the extensible structure to a particular geometry of use.

C. Maximizing Grid Bone Compression

Referring again to FIG. 51, when a conventional tubular expandable structure 856 is shown in FIG.

substantially stretched, the material of this structure is extended to the conical end portions 862 near the ends 858 that are connected to the catheter tube 850. FIG. 59 shows the geometry of the expanded tubular expandable structure 856 in greater detail. Conical end portions 862 ¹⁵ extend at an angle α of the conical opposite ends 858. Consequently, the expanded expandable structure 856 presents a generally cylindrical intermediate region 864 in which the maximum diameter of the expandable structure 856 (BODY _dia ) is located, and the conical end portions 862 a diameter region that decreases with distance from the central region 864 until it reaches the catheter tube diameter (TUBE _DIA ).

Due to the geometry shown in Fig. 59, there is no maximum compression of the lattice along the entire length (L2) of this conventional extensible structure 856, measured between the connected opposite ends 858. Instead, the maximum compression of the lattice is only along the effective length (L1). a cylindrical intermediate region 864 of the expandable structure 856, wherein the expandable structure has its maximum

3q diameter BODY _dia . Compression of the lattice bone decreases along the length of the conical end portions 862, where the diameter of this conical end portion 862 also decreases.

Μ · · · ·

I · ·

The construction gradually decreases. There is no compression of bone at the point of attachment of the attached opposite ends 858 in the portions of the catheter tube 850 that extend beyond these attached opposite ends 858. The catheter tube 850 may be arranged at its proximal end similar to the catheter tube 850 shown in FIG. 50, with a handle 851 made, for example, of a foam material.

The lengths (Lc) of the conical end portions 862 and the connected opposite ends 858 relative to the entire length ^{10 of the} expandable structure 856 (L2) are important features of the overall effectiveness of the expandable structure 856 for compressing the lattice bone. The effective bone compression length (L1) of any extensible structure having conical end regions, such as the extensible structure 856 shown in Fig. 59, can

-1-5 be expressed as follows:

L1 = L2 - 2.Lc where the length of a given conical region (Lc) can be expressed as follows:

Lc = h / tan (oc / 2) where:

²⁵ h = (BODY _dia - TUBE _DIA ) / 2 where (see Fig. 59):

BODY _dia is the maximum diameter of the middle region 864 when substantially expanded, ·· · · · · ·

TUBE _dia is the catheter tube diameter 850, and α is the conical section angle.

As the preceding expressions demonstrate, for a given angle α of the conical portions, the length Lc of the conical end portions 862 will increase with increasing maximum diameter of the BODY _{dia of the} middle region 864. Thus, when the diameter of BODY _{dia is} increased to maximize the diameter of the cavity formed. length Lc of the conical end portions 862, thereby reducing the effective length L1 of the maximum compression of the lattice bone.

The bone compression efficiency of an extensible structure of a given maximum diameter increases as L1 and L2 approach each other. The geometry of the conventional tubular expandable structure 856 shown in FIG. 59 is an inverse relationship between the maximum compression diameter and the effective compression length. These inherent indirect dependencies then make it difficult to optimize the expandable structure 856 for bone compression application.

Fig. 60 shows an improved extensible structure 870 having geometry when substantially expanded that reduces the indirect dependence between the maximum compression diameter and the effective compression length. The 25 extensible structure 870 includes an intermediate region 872 where the diameter of the BODY _dia . The extensible structure 870 also includes end regions 874 that extend from an intermediate region 872 to regions 876 in which the expandable structure material is coupled to the catheter tube 878 where the TUBE _DIA diameter is located. Tube 878 catheter

Can be arranged at its proximal end similar to the catheter tube 850 shown in Fig. 50, with a handle 851 made, for example, of a foam material.

In the embodiment shown in Fig. 60, the end c regions 874 are formed or molded to form a transition with a non-conical diameter between the diameter BODY _dia and the diameter TUBE _DIA . The diameter varies over two predefined radial sections r _x and r ₂ forming a composite curve in the end regions 874 instead of a conical shape. This non-tapered diameter transition formed by the radial sections r _x and r ₂ between the BODY _DIA diameter and the TUBE _DIA diameter reduces the difference between the effective compression length L1 of the expandable structure 870 and the total length L2 of the expandable structure 870 measured between the attachment regions 876.

^{15 Dec}

Fig. 61 shows another improved extensible structure 880 having geometry reducing the indirect relationship between the maximum compression diameter and the effective compression length. Similar to the extensible structure 870 shown in Fig. 60, the extensible structure 880 in Fig. 61 includes a central region 882 with a diameter BODY _dia and end regions 884 extending from the intermediate region 882 to the attachment regions 886 having a diameter TUBE _DIA . As in the extensible structure 870 of Fig. 60, the end regions 884 of the extensible structure 880 form a transition with a non-conical diameter 25 between the diameter BODY _d1a and the diameter TUBE _DIA . In Fig. 61, the predefined radial sections r _r and ar _{2 are} reduced compared to the radial sections r _x and ar ₂ in Fig. 60. As a result, the end regions 884 have an inverted profile. As a result, the entire length L2 between the attachment regions 886 becomes actually less than the effective length L1 of the maximum diameter BODY,

The catheter tube may be arranged at its proximal end similar to the catheter tube 850 shown in Fig. 50, with a handle 851 made, for example, of a foam material.

The extensible structures 870 and 880 shown in Figs. 60 and 61, when substantially expanded or inflated, present, for a given total length L2, regions of gradually increasing effective length L1 where maximum lattice compression occurs.

In addition, as shown in Fig. 61, the end regions 884 are reversed around the attachment regions 886. As a result of this inversion, the bones in the lattice bone around the attachment areas 886 are compressed. Thus, reversing the end regions 884 around the attachment regions 886 allows to compress the lattice bone along the entire length of the extensible structure 880.

Referring to Fig. 62, another embodiment of an improved extensible structure 890 is shown. Like the extensible structure 880 shown in Fig. 61, the extensible structure 890 includes an intermediate region 892 and a fully inverted end region 894 extending over the attachment regions 896. This extensible structure 880 comprises or is represented, when substantially folded, by a single tube. At least the distal end of this tubular expandable structure 880 is mechanically attached or folded in and placed in contact with the catheter tube 898. As shown in Fig. 62, both the proximal and distal ends of this tubular expandable structure are folded and placed in contact with the catheter tube 898. The catheter tube 898 may be arranged at its proximal end similar to the catheter tube 850 shown in FIG. 50, with a handle 851 made, for example, of foam material.

· ... .. ... · ♦ .. .. «« «« «« .. .. .. .. .. .. .. .. .. .. .. .. ..

The catheter tube 898 is previously immersed in or sprayed onto a material 1102 that absorbs selected welding energy, such as laser energy.

The folded end regions 894 are provided from the abutting contact against this material 1102. The welding energy transferred from an external source through the intermediate region 992 is absorbed by the material 1102. A weld is formed that connects the material 1102, the folded end regions 94 and the catheter tube 898. This weld forms the connection areas 896.

The inverted end regions 894 of this extensible structure 890 achieve abrupt termination of the extensible structure 890 in close proximity to the distal end 1104 of the catheter tube 898 so that the end regions 894 and the distal end 1104 of the catheter tube have a common end boundary.

This extensible structure 890 occupies a region of maximum diameter of the structure to maximize compression of the lattice bone substantially along its entire length. The extensible structure 890 does not represent any portion along its length in which the compression of the bone is substantially reduced or there is no compression of the lattice bone.

63 and 64, another embodiment of the expandable structure 1110 is shown. As shown in Fig. 64, the expandable structure 1110 includes a central region 1112 with a maximum diameter BODY _dia and inverted end regions 1114 that extend over the attachment regions 1116.

Fig. 63 shows the extensible structure 1110 before the end regions 1114 have been inverted in the manufacturing process. As shown in Fig. 63, the extensible structure 1110, when substantially folded, comprises or is represented by a single tube. To facilitate the formation of the inverted end regions 1114 and the attachment regions 1116, a two-piece catheter tube is formed to facilitate the formation of the inverted end regions 1114 and the attachment regions 1116. comprising an outer catheter tube 1118 and an inner catheter tube 1120.

The catheter inner tube 1120 slides within the outer tube

1118 catheter. The outer catheter tube 1118 at its proximal end may be arranged similar to the catheter tube 850 shown in Fig. 50 with a handle 851 made, for example, of foam material.

As shown in Fig. 63, during the manufacturing process, the inner catheter tube 1120 is offset by a first distance d1 beyond the outer catheter tube 1118. In this state, the proximal end 1122 and distal end 1124 tubular expandable structure 1110 joined without folding or pressing inwardly about the inner catheter tube 1118, respectively the outer tube ¹⁵ of the catheter 1120. Untranslated ends

1122 and 1124, the tubular expandable structures 1110 may then be directly subjected to conventional bonding or fusion bonding processes to form attachment areas 1116.

Once these attachment areas 1116 are formed, the inner catheter tube 1120 (see arrow 1130 in Fig. 64) is moved to a distance d2 (shorter than the first distance d1) from the end of the outer catheter tube 1118. A shortening of the catheter inner tube 1120 relative to the catheter outer tube 1118 reverses the ends 1122 and 1124. This inversion creates the double inverted connection end regions 1116 shown in FIG.

64 that extend over the connection areas 1116. The relative position of the outer and inner catheter tubes 1118 and 1120 shown in FIG. 64 is secured against further displacement, for example, by glue, which completes the formation of the expandable structure 1110.

ft ftft ftft ft ··· ftft ftft ft ··· ftftft 19 11

I 11111 ftftft · ftftft · 9 19 111

II 11 ftftft ·· • ftft ftft ·· ftft ftftft ·· ··

The double inverted extensible connection end regions 1116 shown in Fig. 64, like the simple inverted extensible connection end regions 894 shown in Fig. 62, ensure that no part of the catheter tube protrudes beyond the extensible structure. Thus, there is no region along any of the extensible structures 890 or 1110 in which the lattice bone will not be compressed. Similar to the expandable structure 890 shown in Fig. 62, the expandable structure 1110 shown in Fig. 64 also presents the maximum diameter for maximum compression of the lattice bone substantially along its entire length.

Fig. 65 shows another embodiment of an improved extensible structure 1300 that is particularly suitable for

Ί F introduction into the inner area of the body bone. Similar to the expandable structure 1110 shown in FIG. 63 and FIG.

64, also includes the extensible structure 1300 shown in FIG. 65, an inner catheter tube 1304 secured within the outer catheter tube 1302. Similar to extensible

63 and 64 also extend the distal end 1310 of the inner catheter tube 1304, as shown in Fig. 65, beyond the distal end 1308 of the outer catheter tube 1302.

The outer diameter of the catheter inner tube 1304 is similarly smaller than the inner diameter of the catheter outer tube 1302. A flow passage 1312 is defined between the two catheter tubes 1302 and 1304.

The proximal end 1314 of the extensible body 1306 is connected to the distal end 1308 of the outer catheter tube 1302.

The distal end 1316 of the extensible body 1306 is connected to the flute flute flute flute flute flute flute flute flute flute flute flute flute flute flute flute flute flute flute flute flute flute flute flute flute flute flute flute flute flute flute flute flute flute catheter. The inflation medium 1318 is conveyed to the expandable body 1306 through the flow passage 1312, causing the expandable body 1306 to expand.

In Fig. 65, the physical properties of the extensible structure 1300 at the proximal end 1314 of the body differ from the physical properties of the extensible structure 1300 at the distal end 1316 of the body. These different physical properties are created through the choice of materials. More specifically, ³⁹ thus are materials selected for the inner catheter tube 1304 and the expandable body 1306 more flexible (i.e., more elastic) than the materials selected for the outer catheter tube 1302. In a preferred embodiment, the materials selected for the expandable body 1306 and the inner tube 1304

° C ° catheter hardness values less than approximately 90 A measured according to Shore and elongation at break greater than approximately

450%, such as more flexible polyurethanes. In a preferred embodiment, the materials have been selected for the outer tube

1302 catheter hardness values greater than about 45 D as measured by Shore < 7 > and an elongation at break less than about 450%, such as having less compliant polyurethanes or polyethylenes.

Due to the different choice of materials, the lack of compliance of the catheter outer tube 1302 at the proximal body end 1314 is balanced during expansion of the expandable body 1306 against the compliance of the catheter inner tube 1304 at the distal body end 1316. The various compliance properties cause the extensible body 1306 to increase in length as it extends, as its diameter increases as it extends. Through a more yielding * · φ φ · 9 ·· ·· ·· ·· · · · 9 · 9 · 9 · 9 9 9 9 9 9 9 9 9 9 9

9 9 9 9 9

999 9999 99 999 99 99 of the extensible body 1306 and the catheter inner tube 1304 is the extensible structure 1300 shown in FIG. However, the expandable structure 1300 is limited from being excessively expanded by securing the proximal end 1314 of the expandable body 1306 to the less elastic catheter outer tube 1302.

The connection between a given expandable structure and its * _e "associated catheter tube can be strengthened through the use of CO ₂ or NdYAG laser to weld the structure and the expandable material of the catheter tube together. Factors that affect bond strength include wavelength energy, energy pulses width, energy pulses period ¹⁵ , maximum stress, point size, rotation speed, working distance, angle of incidence, and material selection.

The outer catheter tube 1302 may be arranged at its proximal end similar to the catheter tube 850 shown in Fig. 50, with a handle 851 made, for example, of foam material.

D. Introduction to vascular tissue

Fig. 66 shows blood vessel tissue region 1400. This region 1400 includes a first blood vessel 1402 that extends along a first axis 1404. The region 1400 also includes a second blood vessel 1406 that deviates from the first blood vessel 1402 along a second axis 1408 displaced relative to the first axis 1404.

Fig. 66 also shows the presence of occlusion 1410 in close proximity to second blood vessel 1406. This occlusion is " 9,999,999,99,99 " 9,999,999

9 9 9 9 9 9 9 9

9 · 9 9 9

9 99 * 9999

999 9900 99 9 · 9 9 · 9 ·

1410 may include, for example, forming plaque along the inner wall of the second blood vessel 1406.

Fig. 67 illustrates the distal end of the instrument 1412 that has been introduced into the blood vessel tissue region 1400 to open the occlusion 1410. The instrument 1412 includes a catheter tube 1416 that carries at its distal end an expandable structure 1420 of the type shown in Figs. 56A. The catheter tube 1416 may be arranged at its proximal end similar to the catheter tube 850 shown in FIG. 50, with a handle 851 made, for example, of foam material.

The catheter tube 1416 is inserted through a conventional vascular inserter and, with fluoroscopic tracking, is guided to the target area 1400 along the guide wire 15

1430 is inserted inside the first and second blood vessels 1402 and 1406. The expandable structure 1420 is expanded using a sterile fluid such as saline or radiological contrast medium. Fig. 67 shows an extensible structure 1420 in a substantially expanded state.

Similar to the extensible structure 820 shown in Fig. 56A, the major axis 1422 of the extensible structure 1420 shown in Fig. 67 and the axis 1424 of the catheter tube 1416 are not aligned. Instead, the main axis 1422 of the structure is offset at a selected acute angle θ from the catheter tube axis 1424. As a result of this displacement angle roz, the extensible structure 1420, when substantially expanded (as shown in Fig. 67), is not symmetrical with respect to the catheter tube axis 1424.

♦ · «*

9 9 99 9 • ··

9 9 9 9 9

9,99999 «• 9 9 9 9 9 9 9 9 9 9

9 9 9 9 9

999 9999 99 999 ·· ··

As shown in FIG. 67, asymmetric expansion of the extensible structure 1420 allows the physician to keep the catheter tube 1416 in axial alignment with the first blood vessel 1402, while maintaining the extensible structure 1420 in axial alignment with the second blood vessel 1406. In this orientation, stretching the extensible structure 1420 inside. The asymmetry of the expandable structure 1420 relative to the catheter tube 1416 thus allows access to the branched blood vessels without complicated handling and control.

E. Deflection of structure

In all of the preceding embodiments, the length of the associated catheter tube extends within the extensible structure. In the embodiments shown in Fig. 51, Fig. 56A, Fig. 56B, Fig. 15

58A, 58B and 59-62, the closed or wrapped catheter tube comprises an extension of the catheter main tube. In the embodiments shown in Figs. 63-65, the closed catheter tube comprises a separate catheter tube supported by the catheter main tube.

Regardless of the particular construction (see Fig. 68), the closed length of catheter tube 1600 forms an internal cavity 1602 extending within the expandable structure 1604. This internal cavity 1602 allows passage of a reinforcement element or probe wire 1606 made, for example, of stainless steel or molded plastic material.

The presence of the probe wire 1606 serves to maintain the extensible structure 1604 in the desired distally straightened condition during passage through the associated guide sheath.

1608 toward the target body region 1610 as shown in FIG

99 • 9-9

9 9 9

9

9 9 9 9 99

9 ····

9 • 999

9999 of FIG. 68. Access to the body target area 1610 through the guiding sheath 1608 may be accomplished using a closed, minimally invasive procedure or an open procedure.

As shown in FIG. 69, the probe wire 1606 may have a preformed memory, typically to bend the distal region 1612 of the probe wire 1606. This memory is surpassed to straighten the probe wire 1606 confined within the guide sheath 1608 as shown in FIG. 68. However, when the extensible structure 1604 and the probe wire 1606 are moved and released from the guide sheath 1608 and passed to the target area 1610, the preformed memory bends the distal area 1612 of the probe wire. The bending of the distal region 1612 of the probe wire bends the catheter tube 1600, thereby shifting the axis 1614 of the attached expandable structure 1604 relative to the access path axis 1616 (i.e., the guide sheath 1608). The pre-bent probe wire 1606 positioned within the interior of the expandable structure 1604 further assists in changing the geometry of the expandable structure 1604 in accordance with the desired orientation when the expandable structure 1604 is introduced for use in the target area 1610.

V. Single use

Stretching any one of the extensible structures described herein during first use in the target region of the body to create stresses on the material or materials from which such a structure is formed. The material stresses created by the work loads during the first use in the target area of the body can significantly change the molded morphology of the expandable structure, making the future operation of such a structure unpredictable.

flfl fl flfl flflfl · flfl flfl • flflfl flflfl flflfl fl flfl · • · ·· · flflfl • flflfl «flflfl flflfl • flfl fl flfl flfl fl flfl • ···· flfl flflfl flfl flfl

For example, stretching within the bone during one use creates contact with the surrounding cortical and lattice bone. This contact can damage the expandable structure, creating localized areas of attenuation that can escape detection. The existence of such localized areas of attenuation can unpredictably cause an overall failure of the extensible structure during possible subsequent use.

In addition, exposure to blood and tissues during one use may capture biological components on or within the extensible structure or associated catheter tube. Regardless of purification and subsequent sterilization, the presence of trapped biological components may lead to unacceptable pyrogenic reactions.

As a result, after the first use, the expandable structure cannot be relied upon to achieve its desired configuration during subsequent use, and the structure may no longer meet the set parameters and sterilization specifications. The effects of material stress and damage caused during a single use in conjunction with the possibility of pyrogenic reactions, even after re-sterilization, logically justify the introduction of a single use restriction for a device that carries these expandable bone delivery structures.

To protect patients from possible adverse consequences caused by multiple uses that include disease transmission, or material tensions and instability, or reduced or unpredictable performance, the present invention

70 also provides a kit 1500 (see Figs. 70 and 71) for accommodating a disposable probe 1502 that carries an extensible extensible probe 1502. 9 ' ' 9 " ", " " ", " " structure 1504, described in this description, prior to introduction into bone.

In the illustrated embodiment (see Figs. 70 and 71), the kit 1500 includes an inner tray 1508. This inner tray 1508 holds the probe 1502 in a flat, upright state during sterilization and storage prior to its first use. The inner tray 1508 may be formed from molded cardboard or thermoformed plastic material. The tray 1508 includes one or more spaced tabs 1510 that hold the catheter tube 1503 and the extensible structure 1504 in the desired flat, upright state. As shown, the leading ends of the tabs 1510 present a contiguous, serpentine geometry, occupying substantially the entire width of the catheter tube 1503 to secure the catheter tube 1503 securely to the inner bowl 1508.

Kit 1500 includes an inner wrapper 1512 that is circumferentially sealed with heat or the like to close the inner cup 1508 from contact with the external environment. One end of the inner wrapper 1512 includes a conventional tear-off seal 1514 (see Fig. 71) to provide quick access to the inner tray 1508 in the case of use that typically takes place in a sterile environment such as the operating room environment.

The kit 1500 also includes an outer wrapper 1516, which is also circumferentially sealed with heat or the like to close the inner wrapper 1512. One end of the outer wrapper 1516 includes a conventional tear seal 1518 (see Fig. 71) to provide access to the inner wrapper 1512 that can to be removed from the outer cover 1516 at

ΦΦ ΦΦ

Φ Φ · Φ

Φ Φ Φ *

Φ Φ 4 Φ ·

Φ · Φ ·

ΦΦ ΦΦ • Φ φφφφ φ

• 4944 • * Φ

Φ 4 φ φ φ

ΦΦΦ Φ

Φ · Φ

Aném the intended immediate use of probe 1502 without disturbing the sterility of probe 1502 itself.

Both the inner and outer covers 1512 and 1516 (see Fig. 71) each include a circumferentially sealed topsheet 1520 and a bottomsheet 1522. In the illustrated embodiment, the topsheet 1520 is made of a transparent plastic film such as polyethylene or MYLAR ™, The bottom sheet 1522 is made of a material that is permeable to EtO sterilizing gas, such as a TYVEC ™ plastic material (available from DuPont).

The sterile kit 1500 also carries a label or insert 1506 that includes a notification, for example, for single use only, to actively warn against reuse of the contents of kit 1500. This label 1506 also preferably actively instructs probe 1502 not to be re-sterilized. Label 1506 also preferably instructs the physician or user to dispose of probe 1502 and the entire contents of kit 1500 after use in accordance with applicable bio-waste disposal procedures. The presence of probe 1502 packaged in kit 1500 confirms to the physician or user that probe 1502 is sterile and has not been subjected to prior use. The physician or user is thereby assured that the extensible structure 1504 meets the set requirements and specifications for its performance and sterility and will have the desired extensible configuration for use.

AND.

Insertion of filling material

Two-phase filling

VI.

♦ · « 99 1111 11 11 ♦ · · · 1 1 1 1 1 • • • · 1 1 111 1 1 1 • • ♦ 1 1 1 1 1 1 • • 11 1111 11 111 11 44

Giant. Figs. 39A-39D illustrate a multi-phase process for delivering filler material to a cavity formed by an expandable body within a lattice bone. This process is illustrated in conjunction with the treatment of the vertebral body, which is selected for illustration purposes only. It should be understood that the described process can be used in the treatment of all bone types.

The use of a multi-stage process is indicated when preliminary examination of the target bone reveals that part of the cortical

F) the bone 28 has been broken or collapsed (as shown in Figure 39A in the anterior region of the vertebral body 26). The collapsed cortical bone 28 thus forms crevices and cracks (indicated by the reference numerals in Fig. 39A as crevices and cracks G).

Typically, residual fragments 500 of the collapsed cortical bone can be collapsed

28 lie in the lattice bone 32 in the area in which the cortical bone has failed. The filler material can flow or leak through these slits and cracks G out of the inner bone volume.

The process begins when the outer guide shell 72 has already been inserted and the guide pin has been removed as described above. The physician introduces the first extensible body 502 into the lattice bone 32 near the collapsed region of the cortical bone as shown in FIG.

39A. The first extensible body 502 is formed with dimensions when substantially expanded to occupy a relatively small volume (i.e. less than about 20%) of the volume of the lattice bone 32 in the inner volume 30.

The doctor expands the first extensible body 502,

30 wherein it compresses a relatively small region of the lattice bone. After folding and removal of the first expandable body 502.

Φ Φ Φ φ φ φ φ φ φ φ • • ΦΦ ΦΦ φ «« · · · · · · zůstává zůstává zůstává φ φ φ φ φ φ φ φ φ zůstává a small cavity 504 caused by compression (as shown in FIG. 39B).

The physician introduces the injection tip 90 and injects a sample of filler material 96 (1) (e.g., from about 1 cc to about 9 cc) into the formed small cavity 504 (as shown in FIG. 39B).

Within a short period of time (before the padding material 96 (1) is allowed to substantially solidify and cure), the physician removes the injection tip 90 and introduces the second expandable body 506 into the lattice bone 32 (see Figure 39C). This second extensible body 506 is larger than the first extensible body 502. The second extensible body 506 is formed with dimensions to create the desired geometry of the therapeutic main cavity 508 in the lattice bone 32.

As shown in Fig. 39C, stretching of the second extensible body 506 moves the previously injected filler sample 96 (1) ^{in the} small cavity 504 toward the collapsed cortical bone region. A sample of padding material 96 (1) envelops residual cortical bone fragments 500 that lie in its path. The padding material 96 (1) and the wrapped fragments 500 are pressed against the collapsed region of the cortical bone as the expansion of the second expandable body 506 proceeds. The second expandable body 506 is folded and removed leaving the main cavity 508.

As shown in Fig. 39D, the first filler sample 96 (1) forms a viscous or (over time) solidified edge region along the leading edge of the main cavity 508. As the subsequent injection of further filler material 96 (2) continues into the main cavity 508 as is shown on

00

0 0 9

0 0 0 0 000 • 0 0

0 0 0 0 • 0 0

0 * «

0 9 0

Referring to Fig. 39D, the viscous or solidified edge area with filler material 9.6 (1) prevents further filler material 96 (2) from passing when the material fills the main cavity 508. The viscous or solidified edge area of filler material 96 (1) serves as a dam that prevents further filler material 96 (2) entering the main cavity 508 from leaking from the vertebral body 26.

B. Internal strainers

Figures 40 and 41 illustrate the use of an inner mesh 510 in conjunction with the introduction of filler material into a cavity formed by an expandable body in a lattice bone.

This inner mesh 510 is shown in conjunction with the treatment of the vertebral body, but it should be understood that the described process can be used to treat all types of bone.

The use of inner mesh 510 is indicated when a pre-examination of the target bone reveals a collapsed area of the cortical bone (as shown in Figure 41 in the anterior region of the vertebral body 26) associated with a lack of sufficient

20, the amount of bone mass, due to advanced disease or complex fracture, to adequately fill the collapsed cortical bone region by compression using an expandable body. The flowable mastic material can flow or leak through unfilled slits or cracks (designated in FIG. 41 as slits and cracks G) present in the collapsed cortical bone region.

The inner mesh 510 comprises a woven structure made of a biocompatible material such as Goretex ™, Nitinol ™, or Dacron ™. The mesh presents a surface area that is approximately 1/3 to 1/2 · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · The inner surfaces of the main therapeutic cavity 84 formed by the selected extensible body.

Prior to insertion of the injection tip 90 into the formed cavity 84 (which is introduced in Figure 41 via a posterolateral approach), the physician hangs the inner mesh 510 over the injection tip 90 as shown in Figure 40.

As shown in FIG. 41, the viscous flow of filler material 96 injected from the injection tip 90 introduces the inner mesh 510 into the cavity 84 in front of the filler material 96.

The inner mesh 510 is pushed by the filler material 96 into contact with the anterior bone region, including the collapsed cortical bone region. The inner mesh 510, impregnated with the viscous material 96 and resting over the collapsed cortical bone region, prevents the filler material 96 from passing until even 5 has solidified.

VII. Administration of therapeutic materials

The cavity formed in the lattice bone by any of the expandable bodies as described above may be filled with a suitable medical device, such as a medicament or growth factor.

The extensible body may compress the infected lattice bone to create a space that may be filled with antibiotic gel in an open or minimally invasive procedure. The cavity places and holds the desired amount of drug exactly at the point of treatment and protects it from being rinsed away with blood or other liquids.

Not only can the dose be optimized, but other doses can be administered later without an open surgical procedure, which improves the overall therapeutic outcome. If the desired cavity for an optimum dose of medication weakens the bone, the bone may be protected from future fracture by a plaster cast or by simultaneous internal or external metal or plastic fixation devices.

The therapeutic substance inserted into the bone may also act outside the bone. A composition comprising a chemotherapeutic agent could be used to treat local solid tumors, localized multiple myelomas, or even close osteosarcomas, or other tumors near the bone.

The cavity formed by the expandable body may be filled with a suitable carrier material, such as an acrylic bone mastic or a biocompatible bone substitute that carries the therapeutic substance. Alternatively, the therapeutic substance may be separately administered prior to injection of the filler material. Thus, using an expandable body, the physician is able to treat the fracture while also delivering the desired therapeutic substance (such as an antibiotic, bone growth factor, or osteoporosis drug) to the site.

As an alternative, the extensible bodies for administration of therapeutic substances may be immersed in a medicament (often a powder, liquid or gel) containing a medically effective amount of any desired antibiotic, bone growth factor or any therapeutic agent to coat the extensible body with the aforementioned substance. introduced into the bone being treated. Optionally, the coated expandable body may be dried with air or other means when the applied composition is wet, such as a liquid or gel.

• ·· * · ·· »* • 4 » »· • · · · • • • • • • • • · • • »· * • • • • • • · • • • * • • ··· • Φ

The extensible body is refolded as required and either used immediately or stored as appropriate and desirable. Coated on the expandable body, the therapeutic substances may be administered while the lattice bone is compressed, or with another expandable body once the cavity has been formed.

The methods described above can also be used to coat Gelfoam or other agents on an expandable body prior to use. The expansion of the extensible θ body coated with Gelfoam inside the bone further fills any cracks in the broken bone that have not yet been filled with compressed lattice bone.

42A-42C schematically depicts one system and method for administering a therapeutic substance to a bone using an expandable body 529. This expandable body 529 is supported at the end of a catheter tube 530 that transports fluid to expand the expandable body 529 as was described in the foregoing description.

As shown in Fig. 42A, the extensible body

529, in a substantially stretched state, is stabilized by a clip 531 that connects the catheter tube 530 to the wire 532. As shown in FIG. 42B, a measured amount of gel composition containing the desired amount of substance 533 is uniformly dispensed from container 534, preferably in thin lines

535, on the outer surface of the expandable body 536. The coated substance may be any desired compound in its natural state (solid, liquid or gaseous) or in a suitable composition, including a powder, aerosol or solution. As shown in FIG. 42C, the expandable body is coated

537 folded and allowed to dry until the gel solidified.

· · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · ··· «··· ·· ··· coated

Alternatively, the expandable body 536 may also be without prior expansion. The possible drying time will of course depend on the nature of the compound and the composition.

The coated expandable body 537 is suitable for packaging for use by a surgeon.

The administration of the therapeutic substance to the exterior of the expandable body used for bone compression, or with the expandable body introduced after bone compression, is qualitatively different than delivering the prepared drug to the bone.

Iny) cavities. When administered while the bone is compressed, the therapeutic substance is incorporated into the compressed bone. This can serve as a method for instantly creating a slow release version of the substance.

The cavity formed by an expandable body ¹⁵ can be filled with an appropriate supporting material, like acrylic bone cement or biocompatible bone substitute, as described above.

Medically effective amounts of therapeutic substances 20 are defined by their manufacturers or guarantors and generally range from 10 nanograms to 50 milligrams per site, although more or less may be required in specific cases.

For example, the cavity may receive a conventional dose of the antibiotic, gentamicin, to treat local osteomyelitis. The usual dose is about 1 gram, although the therapeutic range for gentamicin is substantially greater, from 1 nanogram to 100 grams, depending on the condition to be treated and the size of the area to be treated. Medically suitable gel formed with suitable gel materials, such as polyethylene glycol, may contain 1 gram of gentamicin in a set gel volume such as 10 cc.

Other antibiotics that can be used to treat bone marrow inflammation include, for example, ancef, nafcillin, erythromycin C _E, tobramycin and gentamicin. Typically, bone growth factors are members of the alpha and beta groups of morphogenetic bone factor, osteogenic protein, fibroblast growth factor, insulin growth factor and transforming growth factor. Chemotherapeutic and related agents include compounds ¹⁰ such as cisolatin, doyubicin, daunorubicin, methotrexate, taxol and tamoxifen. Osteoporosis medications include estrogen, calcitonin, diphosphonates, and parathyroid hormone antibodies.

VIII. Administration of biological materials

The cavity formed in the lattice bone by any of the extensible bodies described above may also be filled with biological materials.

Biological materials that do not flow into the formed cavity, such as hydroxyapatite granules or bone mineral mass, can be extruded through a tube through a long pin whose diameter is slightly narrower than the inner diameter of the outer guide sheath using a minimally invasive procedure. During open surgery, the doctor can access the bone in the same way.

If the biological material to be introduced does not flow and should not be forced into the cavity through the outer guiding sheath (as is the case with the hydroxyapatite block, as this may cause damage), the physician may create a 30 cavity using a minimally invasive approach, Punch a hole using standard tools (such as a punch, groove or rasp) into the side of the cortical bone to allow insertion of the block.

IX Collecting bone marrow

Any of the extensible bodies described above can also be used in obtaining bone marrow for diagnostic or therapeutic purposes, for example, in the diagnosis of multiple myeloes or in the treatment of advanced stages of cancer with bone marrow transplants.

Fig. 47 illustrates a bone marrow harvesting system 700 in bone marrow 702. The bone 702, which is shown schematically in Fig. 47, may include, for example, a pelvis, or a vertebral body, or a distal spindle bone.

System 700 uses a bone marrow collecting tool 704. The instrument 704 includes a catheter tube 706 that supports the expandable body 708 at its distal end. The tool 704 may be introduced into bone 702 using a minimally invasive approach as described above.

The catheter tube 706 has three coaxial and independent cavities

710, 712 and 714 (see Fig. 48). The outer cavity 710 is connected to the interior of the expandable body 708 and is connected to the source

718 inflatable (or expansive) fluids. The middle 25 cavity 712 is connected to a flushing fluid source 720 and a distal opening 716 on the catheter tube 706. The central cavity 714 is connected to the collecting container 722 and the second spacing opening 724 on the catheter tube 706.

The extensible body 708 is introduced in a substantially collapsed state as described above.

• 4 4 4 444 444 444 444 444 44 44 44 44 44 44 44 44 44 44 44 44 44

The inflatable fluid, which is preferably radiation impermeable, is conveyed from the source 718 to the expandable body 708 for expanding it.

As shown in Fig. 48, the extensible body is limited by the selection of relatively non-elastic materials or by external constraints (as described above) to adopt an elongate shape. The stretching of the expandable body 708 creates a relatively shallow area 726 of compression of the lattice bone 728 along a relatively long length. The size and shape of the expandable body 708 will depend on the geometry of the collection site and the amount of bone marrow required. In long bones such as the distal radius, and in bones and narrow width but with a large area, such as ribs or pelvis, the expandable body 728 is shaped to compress a large area but not with a large depth of the lattice bone 728.

Also, as shown in Fig. 48, as the extensible body 708 expands, the flushing fluid, by which saline solution or other suitable biocompatible liquid, can be conveyed from the flushing fluid source 720 to the compression zone 726 (as shown by arrows 730 on the Fig. 49). The flushing fluid releases biological components (such as red blood cells, bone cells, and body cells) within a defined compression region 726, forming a suspension 732 rich in said components.

The expandable body 708 is then folded and suction is applied through the cavity 714. This suction draws the component-rich suspension 732 from the compression zone 726 into the collection container 722.

The above stretching, flushing, folding, and suction sequence may be repeated to collect another suspension 732 rich in said biological components in the collection container 722. The position of the expandable body 708 in bone 702 may be varied, if desired, to maintain suspension 732 rich in biological components for collection.

The use of the extensible body 708 to form a long but shallow compression region 726 allows the collection of a substantial concentration of therapeutic biological components with less bone damage than conventional collection procedures. If desired, standard gypsum dressings or other fixation devices may be applied to bone 702 after bone marrow collection until bone 702 is healed.

Features of the present invention are set forth in the following claims.

Claims (49)

PATENT CLAIMS A bone delivery tool having a cortical bone surrounding an internal volume occupied, at least in part, by a lattice bone, comprising: a guide tube, an expandable body supported by the guide tube in a generally composite geometry for introduction into the internal volume, a nozzle carried by the guide tube near the expandable body for introduction into the internal volume with the expandable body, a first cavity in the guide tube connected to the expandable body expanding the expandable body in the inner volume to compress the lattice bone and forming a cavity in the inner volume 15, and a second cavity in the guide tube connected to the nozzle to convey material for discharging from said nozzle into the cavity. 20 May The tool of claim 1, wherein the nozzle is a bone sealant injection nozzle. 3. A bone delivery system having a cortical bone surrounding an internal volume occupied, at least in part, by a lattice bone, comprising: an expandable body adapted to selectively incorporate the composite geometry for introduction into the internal volume, the nozzle for introduction into the internal volume to occupy the internal volume with the expandable body, a first element coupled to the expandable body for transporting the medium causing the expandable media to expand and a second element coupled to the nozzle for conveying material for discharging from said nozzle into the cavity, at least partially, while the expandable body occupies the internal volume. The system of claim 3, wherein the nozzle is a bone sealant injection nozzle. A bone treatment system having a cortical bone surrounding an internal volume occupied, at least in part, by a lattice bone, comprising: a first extensible body having a composite geometry for introduction into the internal volume through the first access path in the cortical bone, a second extensible body having a composite geometry for introduction into the internal volume through the second access path in the cortical bone that is different from the first access path; the second extensible body is each adapted to individually receive the expanded geometry to compress the lattice bone to form a cavity in the internal volume. 6. A system for treating a vertebral body having a cortical bone surrounding an internal volume occupied, at least in part, by a lattice bone, comprising: a first extensible body having composite geometry for introduction into the internal volume through a first cortical bone access path that includes either a transpedicular approach or a posterolateral approach, a second extensible body having composite geometry for introduction into the internal volume through a second cortical bone access path that is different from the first access path, and wherein the first and second expandable bodies are each adapted to individually receive the expanded geometry to compress the lattice bone to form a cavity in the internal volume. The system of claim 6, wherein the first and second access paths comprise different posterolateral approaches. The system of claim 6, wherein the first and second access routes include different transpedicular approaches. The system of claim 6, wherein the first and second access routes include a transpedicular approach and a posterolateral approach. A bone treatment system having a cortical bone surrounding an internal volume occupied, at least in part, by a lattice bone, comprising an expandable body comprising: a first extensible zone having a composite geometry for introduction into the inner volume, the first extensible zone being adapted to receive an elongated expanded geometry having a first dimension extending substantially over the inner volume to form a barrier within the inner volume, and a second dimension smaller than the first a dimension, leaving a region of substantially uncompressed lattice bone extending from the barrier within the inner volume, a second extensible zone having a composite geometry for introduction into said region, the second extensible zone being adapted to receive the expanded geometry for 4 4 100 ALIGN! 4,444 compressing the lattice bone to form a cavity in said region while the barrier serves to guide the expansion of the second extensible zone in this region away from the first extensible zone. The system of claim 10, wherein the first and second extensible zones comprise separate extensible assemblies. The system of claim 10, wherein the first and second extensible zones comprise portions of one extensible assembly. 13. A device for introducing into the inner region of a body comprising a catheter tube extending along a first axis and a structure supported by the catheter tube comprising a body adapted to receive composite geometry for introduction into the inner region of the body and an expanded geometry for Use within said inner region of the body, wherein said expanded geometry is oriented about a second axis that is not aligned with the first axis. 14. A bone delivery device having a cortical bone surrounding an internal volume occupied, at least in part, by a lattice bone, comprising: a catheter tube extending along the first axis and a structure supported by the catheter tube comprising a body adapted to receive composite geometry for introduction into the inner region of the body and an expanded geometry to compress the lattice bone to form a cavity in the internal volume, said expanded geometry being 101 • · · · « • · · · • » 9 · • · · • • « • * · • »» • * • • * ·· • • • ♦ • · • • • • • • • • · · ·· • 9 · • · »· oriented about a second axis that is not aligned with the first axis. Device according to claim 13 or 14, characterized in that the second axis is offset from the first axis by a certain angle. 16. The apparatus of claim 15, wherein said angle is an acute angle. Device according to claim 13 or 14, characterized in that the second axis is offset from the first axis by a certain distance. The apparatus of claim 17, wherein the second axis is generally parallel to the first axis. Device according to claim 13 or 14, characterized in that the body comprises conical end portions. The apparatus of claim 19, wherein each conical end portion comprises a conical top secured around the catheter tube. 21. The apparatus of claim 20, wherein at least one of the conical end portions comprises a conical bottom that is oriented generally parallel to the corresponding conical top. 22. The apparatus of claim 20, wherein at least one of the conical end portions comprises a conical bottom that is oriented generally non-parallel to the corresponding conical top. 23. The apparatus of claim 13 or 14, wherein the body comprises a relatively elastic material. * 9 9 9 9 99 9 9 9 9 999 ·· fl • flflfl · · 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 • fl ·· · flflflfl fl flfl 999 99 99 102 24. The apparatus of claim 13 or 14, wherein the body comprises a relatively non-elastic material. 25. A device for introduction into the inner region of the body comprising: a catheter tube having a first diameter, a structure supported by said catheter tube, comprising a body adapted to receive composite geometry for introduction into an inner body region and an expanded geometry for use within the inner body region, 10 „ _z ...... wherein the expanded geometry has a second diameter greater than the first diameter, the body includes spaced end regions, and at least one of these end regions forms a transition with a non-tapered diameter between the first and second diameters. 25 26. The apparatus of claim 25, wherein at least one of the end regions is inverted. 27. The apparatus of claim 25, wherein at least one of the end regions defines a composite curve. 28. The apparatus of claim 25, wherein the end regions are connected to the catheter tube. 29. The apparatus of claim 25, wherein the end regions each comprise a fastening region 25 wherein the end region is secured to the catheter tube, and at least one of the end regions is turned around the corresponding attachment region. ftft · ft · ft · w w w w w w ft. ftft ftftft ftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftftft 103 30. The apparatus of claim 25, wherein the catheter tube comprises a distal end, and one of the end regions faces the distal end of the catheter tube. 31. A device for introduction into the inner region of the body comprising: a first catheter tube having a distal end, a second catheter tube extending beyond said distal end, the second catheter tube being slidably displaceable within the first catheter tube, and a structure supported by the first and second catheter tubes comprising a body adapted to receive composite geometry for introducing into the inner body region and expanded geometry for use within the inner body region, the body comprising a first end region secured to the first catheter tube and a second end region secured to the second catheter tube, sliding the second catheter tube to move the second end region toward the first end regions reverse the first and second end regions around the corresponding first and second catheter tubes. 32. The apparatus of claim 31, further comprising a region securing the first and second catheter tubes to maintain the first and second end regions in an inverted state. 33. A device for introduction into the inner region of the body comprising: a first catheter tube having a distal end, wherein the first catheter tube is made of a first material, a second catheter tube extending beyond said first catheter tube; 104 a distal end, wherein the second catheter tube is made of a second material more pliable than the first material and a structure supported by the first and second 5 catheter tubes comprising a body adapted to receive the composite geometry for introduction into the inner region of the body and the expanded geometry for use within the inner body region, the body comprising a first end region secured to the first catheter tube and a second end region 10 secured to the second catheter tube, and wherein the body is formed of a material that is more flexible than the first material. 34. The apparatus of claim 33, wherein the first catheter tube has an inner diameter, the second catheter tube comprises a portion that extends within the first catheter tube, and said portion of the second catheter tube has an outer diameter smaller than the inner diameter of the first catheter tube. thereby forming a passageway in the first catheter tube for guiding the expanding medium into the body. 35. The apparatus of claim 34, wherein the first material comprises polyurethane or polyethylene. 36. The apparatus of claim 34, wherein: 25 the first material comprises polyurethane. 37. A sterile kit comprising: a bone insertion device comprising a structure adapted to receive expanded geometry having a desired configuration in use, said structure being subjected to stresses when expanded during first use; Φ »·» * * * * »» »» »e e e e e e 105 Φ • φφφφ in bone, and this construction cannot be relied upon to achieve the desired configuration during subsequent bone use, an overwrap defining a sealed sterile container to keep the 5 devices sterile until use. 38. The sterile set of claim 37, wherein the device comprises a catheter tube extending along a first axis, and the structure is supported by the tube. 10 comprises a body adapted to receive compound geometry for insertion into bone and an expanded geometry for use within the bone, said expanded geometry oriented about a second axis that is not aligned with the first axis. 39. The sterile set of claim 37, wherein the device comprises a catheter tube having a first diameter, and the structure is supported by said tube 20 of a catheter and comprising a body adapted to receive composite bone insertion geometry and an expanded geometry for use within the bone, wherein the expanded geometry has a second diameter greater than the first diameter, the body including spaced end regions and at least one of these end regions The 25 regions form a transition with a non-conical diameter between the first and second diameters. 40. The sterile set of claim 37, wherein the device comprises a first catheter tube having a distal end and a second catheter tube extending beyond the catheter. 30, said distal end, wherein the second catheter tube 09 99 0 · · 0 0 ♦ · 0 • • 9 0 9 0 9 9 9 0 1 0 9 0 * ** 0 106 * 9 9 «9» 0 • 009 909 9909 is slidable within the first catheter tube, and the structure is supported by the first and second catheter tubes and includes a body adapted to receive the composite geometry for insertion into the bone and the expanded geometry 5 for use within the bone, the body comprising a first end region secured to the first catheter tube and a second end region secured to the second catheter tube, wherein sliding the second catheter tube to move the second end region toward the first end region reverses the first and 10 shows a second end region around the corresponding first and second catheter tubes. 41. The sterile set of claim 37, wherein the set comprises a first catheter tube having a distal end, wherein the first catheter tube is made of a first material, and a second catheter tube extending beyond said distal end, the second the catheter tube is made of a second material that is more pliable than the first material, and the structure is supported by the first and second 20 May , .... a catheter tube and comprising a body adapted to receive composite bone insertion geometry and an expanded geometry for use within the bone, the body comprising a first end region secured to the first catheter tube and a second end region secured to the second catheter tube, and 25,. the body being formed of a material that is more pliable than the first material. 42. The sterile kit of claim 37, wherein the wrapper comprises a sterile-permeable material 3Q EtO gas. * 00 00 t 0 00 0000 0 0 0 0 0 0 0 · 00 0 « 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 00 • 0 000 0000 0 · 0 000 000 43. The sterile kit of claim 37, wherein the structure comprises a substantially non-elastic material. 44. The sterile set of claim 37, wherein the structure comprises a substantially semi-elastic material 45. The sterile set of claim 37, wherein the structure comprises a substantially elastic material. 46. The sterile set of claim 37, wherein the structure includes constraints to limit the expansion of the structure. 47. A device for introducing into the inner body region, comprising a catheter tube, a structure supported by said catheter tube 15, comprising a body adapted to receive composite geometry for introduction into the inner body region, and expanded geometry for use within the inner region. body, a tube within the structure that defines the inner 20 cavity, and a probe wire in the inner cavity to reinforce the structure. 48. The apparatus of claim 47, wherein the probe wire includes a memory generally bending therethrough 25 is a probe wire within the inner cavity for deflecting the structure relative to the catheter tube. 49. The apparatus of claim 48, further comprising a sheath slidingly enveloping the insertion guiding structure, the sheath extending beyond the probe wire memory 30 to push the probe wire into the general. 9 9 9 9 9 9 · · ♦ ·. · 9 9 9 9 9 9 9 9 * 9 9 9 9 9 9 9 9 9 9 9 999 99 99 99 99 99 108 of the upright configuration when wrapped in the housing, the memory bending the probe wire and deflecting the structure when the structure slips freely out of the housing.