HK1141969A - Articulating cavitation device - Google Patents

Description

Articulated void former

Priority

Priority is claimed in this application for U.S. provisional patent application serial No. 60/939355 entitled "insulating stabilizing Devices" filed on month 5, 21, 2007, U.S. provisional patent application serial No. 60/939365 entitled "extensible Cutting members" filed on month 5, 21, 2007, and U.S. provisional patent application serial No. 60/939362 entitled "Delivery System and method for Inflatable Devices" filed on month 5, 21, 2007, the entire disclosures of which are hereby incorporated by reference.

Technical Field

Aspects of the present invention relate to restoring an anatomical site of a fractured bone (anatomi), and more particularly, to restoring an anatomical site of a fractured bone with an inflatable device.

Background

Surgeons are increasingly utilizing minimally invasive surgical techniques to treat a variety of medical conditions. Such techniques typically involve the insertion of a surgical device through an inherent orifice of the body using a tube or cannula or through a relatively small incision. In contrast, conventional surgical techniques typically involve significantly larger incisions and are therefore sometimes referred to as open surgery. Therefore, the minimally invasive surgical operation method has the following advantages compared to the conventional art: trauma to healthy tissue is minimized, blood loss is minimized, risk of complications such as infection is reduced, and recovery time is reduced. Moreover, some minimally invasive surgical procedures can be performed under local anesthesia, or even sometimes without anesthesia, thus enabling the surgeon to treat patients who cannot tolerate the general anesthesia required by conventional surgical techniques.

Surgery often requires the formation of cavities within soft tissue or hard tissue, including bone. Tissue cavities are formed for various reasons, for example, to remove diseased tissue, to harvest tissue associated with biopsy or autograft, and for implant fixation. To obtain the benefits associated with minimally invasive techniques, tissue cavities are typically formed only by forming relatively small access openings in the target tissue. An instrument or device may then be inserted through the opening and used to form a void that is significantly larger than the access opening.

One surgical application that takes advantage of the formation of cavities within tissues is surgical treatment and prevention of fractures of bones associated with osteoporosis, a metabolic disease characterized by bone mass and a decrease in bone strength. This disease often results in fractures of the bone with mild to moderate trauma and, in its advanced state, can result in fractures under normal physiological loading conditions. Osteoporosis is estimated to affect approximately fifteen to twenty million people in the united states, and approximately one-hundred and thirty million new fractures are associated with osteoporosis each year, with the most common fracture sites being the hip, wrist, and vertebrae.

Emergency (emerging) prophylactic treatment of osteoporosis, trauma, etc. involves replacement of weakened bone with a more solid artificial bone substitute using minimally invasive surgery. Weakened bone is first surgically removed from the damaged area, thereby forming a cavity. The cavity is then filled with an injectable artificial bone substitute and can harden. The artificial bone substitute provides structural reinforcement, thereby reducing the risk of fracture of the damaged bone. Prophylactic fixation of osteoporotically weakened bone performed in this manner is not feasible due to the increased morbidity, blood loss, and risk of complications associated with conventional surgery if minimally invasive surgery is not available. Moreover, minimally invasive procedures tend to preserve more of the integrity of the remaining structure of the bone, as this is minimally traumatic to healthy tissue.

Other less common diseases suitable for the reinforcement of bone structures include bone cancer and ischemic necrosis. Surgical treatment for each disease may include removing diseased tissue by forming a tissue cavity and filling the cavity with a stronger artificial bone substitute to provide structural reinforcement to the damaged bone.

Medical balloons (balloon) are generally known for dilating and opening arteries that enter the heart (percutaneous transluminal coronary angioplasty) and for arteries other than the coronary arteries (non-coronary percutaneous transluminal angioplasty). In angioplasty, a balloon is tightly wrapped around a catheter shaft to minimize its profile and inserted through the skin and into the narrowed portion of the artery. Typically, the balloon is inflated with saline solution or a radiopaque solution, which is forced into the balloon by a syringe. Instead, to contract, a vacuum is introduced into the bladder to collapse it.

Medical balloons for treating bone fractures are also known. One such device is disclosed in U.S. patent No. 5423850 to Berger, which discloses a method and device for emplacing fractured tubular bone using a balloon catheter. The balloon is inserted into the bone through an incision distal to the fracture site, and a guide wire is used to deliver the unexpanded balloon through the medullary cavity and through the fracture site for deployment. The inflated balloon is held firmly in place by applying positive pressure to the intramedullary wall of the bone. Once the balloon is deployed, the attached catheter tube is tensioned with a calibrated force measuring device. Tightening of the catheter with the balloon fixed in place straightens the fracture and compresses the proximal and distal portions of the fractured bone together. The tensioned catheter is then secured to the bone at the insertion site with screws or similar fixation devices.

Drawings

It is believed that the various aspects of the invention will be better understood from the following description when taken in conjunction with the accompanying drawings. The drawings and detailed description that follow are intended to be illustrative of the invention only and are not intended to limit the scope of the invention.

FIG. 1 shows a perspective side view of one version of a trocar and cannula assembly of a vertebral cavity formation and fracture reduction system.

Figure 2 shows a perspective side view of the trocar of figure 1 shown after removal from the cannula of the assembly.

Figure 3 shows a perspective side view of the cannula of figure 1 after removal of the trocar from the assembly.

FIG. 4 illustrates a perspective side view of one version of a drilling tool configured for insertion through the cannula of FIG. 3.

FIG. 5 illustrates a perspective side view of one version of a cavitation instrument of the vertebral cavitation and fracture reduction system shown in an articulated position.

FIG. 6 shows a longitudinal cross-sectional view of the cavity-forming instrument of FIG. 5 shown in a non-articulated position.

FIG. 7 shows a more detailed view of the longitudinal cross-sectional view of FIG. 6, showing the handle portion of the cavity-forming instrument.

FIG. 8 shows a more detailed view of the longitudinal cross-sectional view of FIG. 6, showing the end effector portion of the cavitation instrument in a non-articulated position.

FIG. 9 shows a more detailed view of the longitudinal cross-sectional view of FIG. 6, showing the end effector portion of the cavitation instrument in an articulated position.

FIG. 10 illustrates a perspective side view of one version of a vertebral fracture reduction device of the vertebral cavity formation and fracture reduction system.

Fig. 11 shows a longitudinal cross-sectional view of the vertebral fracture reduction device of fig. 10.

Fig. 12 shows a more detailed perspective side view of the access port and port housing of the vertebral fracture reduction device of fig. 10.

Fig. 13 shows a more detailed perspective side view of the capsule and feeding tentacle of the vertebral fracture reduction device of fig. 10.

Fig. 14 shows a transverse cross-sectional view of the balloon, the feeding lumen, and the insertion sheath of the vertebral fracture reduction device of fig. 10.

FIG. 15 illustrates a flow chart of one version of a method of vertebral cavity formation and fracture reduction.

Fig. 16 shows a longitudinal cross-sectional view of a medical device having an expandable cutting member coupled to a transition member shown in an expanded position.

FIG. 17 illustrates a longitudinal cross-sectional view of the expandable cutting member of FIG. 16 shown in a contracted position.

FIG. 18 illustrates a transverse cross-sectional view of the medical device of FIG. 16 taken along reference line 3-3 showing the transition member.

FIG. 19 shows an alternative longitudinal cross-sectional view of a medical device having an expandable cutting member coupled to a shaft member shown in an expanded position.

FIG. 20 illustrates a longitudinal cross-sectional view of the expandable cutting member of FIG. 19 shown in a contracted position.

FIG. 21 illustrates a transverse cross-sectional view of the medical device taken along reference line 3-3 of FIG. 16, showing one alternative of the transition member.

FIG. 22 illustrates a transverse cross-sectional view of the medical device taken along reference line 3-3 of FIG. 16, showing one alternative of the transition member.

FIG. 23 shows an alternative longitudinal cross-sectional view of a medical device having an expandable cutting member coupled to a shaft member shown in an expanded position.

FIG. 24 illustrates a longitudinal cross-sectional view of the expandable cutting member of FIG. 23 shown in a contracted position.

Figure 25 shows a perspective side view of a delivery system for an inflatable device.

Figure 26 shows a perspective side view of an alternative delivery system for an inflatable device.

Detailed Description

Referring to fig. 1, fig. 1 illustrates one version of a trocar and cannula assembly 10 for use in a vertebral cavity formation and fracture reduction system and method for accessing a vertebral body. The assembly 10 includes a trocar 12 and cannula 14 coupled to a combination or two-piece handle 16. The two-piece handle 16 is configured for rotation and includes a first separable handle portion 18 attached to the trocar 12 and a second handle portion 20 attached to the cannula 14. Rotation of the handle 16 and/or trocar and cannula assembly 10 may be accomplished in any suitable manner, such as manual rotation or motor rotation. The handle 16 is shown as symmetrical, but any suitable offset or asymmetry is contemplated. The two-part handle 16 has a distal surface 17 for gripping by the fingers of a user and a proximal surface 19 for gripping by the palm of the user's hand. The distal end surface 17 of the two-piece handle 16 may have any suitable surface effect, such as, for example, forming a finger grip, a curved surface, a substantially flat surface, a concave surface, and/or a convex surface. The proximal surface 19 on the first separable handle portion 18 may include a surface 21 configured to accept a hammer stroke.

The distal tip 25 of the trocar 12 is configured to enter and pass through the cortical bone of the vertebra into which the engaged trocar and cannula assembly 10 enters. After the vertebrae have been accessed by the distal tip 25 of the trocar 12, the cannula 14 may be advanced into the channel formed by the trocar 12. The trocar 12, which may be made of stainless steel, may be removed from the cannula 14 after entering the vertebrae. Removal of the trocar 12 from the assembly 10 leaves the cannula 14 in place, for example, within the cortical wall of a vertebra, as a conduit for instruments for insertion of any suitable instrument or device. In the illustrated version, the trocar 12 is withdrawn from the cannula 14 by removing the first separable handle portion 18 from the assembly 10 until the trocar 12 is pulled to the proximal end of the cannula 14. The trocar 12 and cannula 14 are shown in more detail in figures 2 and 3.

Referring to FIG. 2, FIG. 2 shows one version of the trocar 12 after removal from the cannula 14 of the assembly 10. The trocar 12 includes an elongated cylindrical body 22 having proximal and distal ends, wherein the proximal end of the body 22 is connected to the first separable handle portion 18 and the distal end includes a distal tip 25, a first penetration member 24 and a second penetration member 26 as shown in figure 1. In the illustrated version, the first separable handle portion 18 includes a grip 28 to facilitate rotation of the penetrating members 24 and 26 to access a vertebra and form a channel into the vertebra. The grip 28 also facilitates separation of the handle portion 18 from the two-part handle 16. Handle portion 18 also includes a connector 30 configured to detachably engage second handle portion 20 coupled to cannula 14. Separating the handle portion 18 from the handle portion 20 allows the trocar 12 to be removed from the cannula 14.

The first penetration member 24 of the trocar 12 is a cylinder having a plurality of intersecting planes, bevels or end surfaces that form a point at the distal tip 25, the distal tip 25 being configured to penetrate tissue and vertebrae by manual rotation and longitudinal articulation. First penetrating member 24 is configured to provide initial access through the patient's skin and into the cortical bone of the vertebra after an incision is made. The relatively small diameter of the first penetration member 24 facilitates insertion and positioning, or repositioning, of the trocar 12. The second penetration member 26 is the transition between the smaller diameter first penetration member 24 and the larger diameter body 22 of the trocar 12 and includes a plurality of flats configured to enlarge the diameter of the passage. In one version, the thicker second penetration component 26 has a sharp edge that facilitates cutting of bone. Providing a double diameter or stepped tip allows for easy insertion and improves stability of the trocar 12. Stepped penetrating members 24 and 26 increase the size of the entry point sufficiently to receive cannula 14 for insertion and retention within the vertebrae.

It should be appreciated that the trocar 12 may be configured with any suitable features to facilitate access to vertebrae, cutting, penetration of cortical bone, or any other suitable use. The trocar 12 may include one or more stepped tips including first and second penetration members 24 and 26 having any suitable cutting effect, diameter, shape and/or configuration. The one or more penetrating members may be sharp, blunt, slotted, or have any other suitable configuration. The distal end of the trocar 12 may be tapered, have a movable cutting member, or may be coated or in any other form attached with a material that facilitates cutting, such as diamond.

Referring to FIG. 3, FIG. 3 shows the cannula 14 after the trocar 12 has been removed from the assembly 10 shown in FIG. 1. In general, the cannula 14 is configured to function as an instrument catheter that is guided into the intervertebral space, or any other suitable tissue space, after the initial access point has been formed and the trocar 12 has been removed. The cannula 14 may remain within the cortical bone of the vertebra during surgery while the second handle portion 20 remains outside the patient as an access port. Cannula 14 includes an elongated cylindrical body 32 formed as a lumen having a proximal end and a distal end, wherein the proximal end of body 32 is connected to second handle portion 20, and the distal end portion includes a bore 34 through which trocar 12 and other instruments are configured to pass. The second handle portion 20 includes a connector 36 configured to engage the connector 30 of the first separable handle portion 18 shown in fig. 2 in a rotating snap-fit manner. The second handle portion 20 includes a bore of the same size and coaxial with the cavity of the cylindrical body 32 to receive an instrument. The cannula 14 also includes a grip 37, which grip 37 facilitates positioning and removal of the cannula 14 after the trocar 12 is removed. The grip 37 and the distal surface 17 of the two-piece handle may be separate and distinct, or alternatively, the grip 37 and the distal surface 17 may form a continuous or substantially continuous surface when the two-piece handle 16 is attached in the assembly 10. In this manner, both grip 37 and distal surface 17 may be used to rotate handle 16 to facilitate access to the vertebrae. Providing a two-part handle with a continuous grip 37 and distal surface 17 can facilitate use of the assembly 10, as shown in FIG. 10, while providing an effective gripping surface for use of the cannula 14 and trocar 12, respectively.

Referring to fig. 4, fig. 4 illustrates one version of a drilling tool 40 for use in accordance with the vertebral cavity formation and fracture reduction systems and methods. The drilling tool 40 includes an elongated stainless steel cylindrical body 42 having a proximal end and a distal end, wherein the proximal end is connected to a handle 44 and the distal end is configured as a drill bit 46. The body 42 of the drilling tool 40 is sized to pass through the central lumen of the cannula 14, and after entering the cannula 14, the drill bit 46 is used to form an access channel, for example, in the cancellous bone of the vertebra. The handle 44 has a grip 48 to facilitate manual rotation of the drill 40 in the cancellous bone of the vertebra to form a passage to the anterior cortex. The body 42 has markings 50 to indicate the minimum depth required for insertion of subsequent instruments. After the access passage is formed, the drilling tool 40 is configured for withdrawal through the cannula 14. Any suitable indicia 50 may be provided using any suitable metric to determine the appropriate insertion.

Referring to FIG. 5, FIG. 5 illustrates one version of an articulating cavitation instrument 100 that may be used, for example, to form a tissue cavity in cancellous bone within a vertebral body. In one version, the cavity-forming instrument 100 is approximately 40cm long and generally includes a handle 102, an insertion member such as an insertion tube 104, and an end effector (end effector)106 configured for articulation. The handle 102 has a generally cylindrical body aligned along a first linear axis a-a, the body having a proximal end and a distal end. The handle 102 includes a body 108 and a series of rotary actuation members 110, 112, and 114 that are rotatable about a first linear axis a-a to articulate aspects of the end effector 106. In the illustrated version, the rotational components 110 and 112 are knobs secured to the central shaft 128 (shown in FIG. 6) and retained within the body 108 of the handle 102. The swivel component 114 is secured within the body 108 of the handle 102 by mating flanges. It should be understood that the illustrated rotational actuation components 110, 112, and 114 are described by way of example only, and that any suitable mechanism, including combinations thereof, such as slides, levers, gear components, etc., may be used to actuate the cavity-forming instrument 100.

An insertion tube 104 of the vertebral cavity formation and fracture reduction system extends axially along a first linear axis a-a from a distal end of the handle 102 to a proximal end of an end effector 106. The insertion tube 104 may be stainless steel and form a lumen with openings at both ends. In the illustrated version, and with particular reference to FIG. 8, the pivot pin 116 is welded to the insert tube 104, wherein the pivot pin 116 is transverse to and offset from the first linear axis A-A. As described herein, the pivot pin 116 facilitates articulation of the end effector 106 such that it is offset from the first linear axis a-a. Pivot pin 116 is an example of an articulation region of the instrument 100.

An end effector 106 having a proximal portion 122 and a distal portion 124 is disposed at the distal end of the insertion tube 104 and is configured to rotate and articulate relative to the insertion tube 104. The proximal end portion 122 of the end effector 106 is connected to the insertion tube 104 with the pivot pin 116 such that the end effector 106 is constrained from axial movement relative to the insertion tube 104, but is able to rotate about the pivot pin 116. In this manner, the end effector 106 can be articulated such that it is offset from the first linear axis a-a, e.g., aligned with the second linear axis B-B. The second linear axis B-B is described by way of example only, and any suitable articulation angle and distance are contemplated.

The distal portion 124 of the end effector 106, which may be, for example, 1.8cm to 2.8cm in length, is configured to rotate about a central axis a-a of the end effector 106 relative to the proximal portion 122 of the end effector 106. The distal end portion 124 of the end effector may also rotate about the second linear axis B-B, or any other suitable offset axis, when the end effector 106 is in the articulated position. Rotation of the end effector 106 in both the articulated and non-articulated positions facilitates formation of cavities by cutting cancellous bone about multiple axes. Providing a large axial extent around which portions of the cavity can be formed facilitates the formation of a larger extent of the cavity structure, which may provide better therapeutic results.

The end effector 106 also includes a side aperture 120 and an aperture 134 through which the flexible cutter 118 expands and contracts. In the illustrated version, the deformable cutter 118 is an elongated flexible strip of stainless steel having a length of between 1.5cm and 3 cm; any suitable cutting element may be utilized, such as, for example, a wire, an energized cutting element, a filament, a cutting element with a free end, a cutting element with memory retention properties, and/or a rotating outwardly expanding cutting element. Any suitable shape is contemplated, such as oval, triangular, or elliptical. In the illustrated version, the distal end of the cutter 118 is fixedly connected to the end effector 106, while the distal end of the cutter is connected via a coupling member 132 to a movable shaft 128, the shaft 128 configured to rotate and translate within the insertion tube 104. The cutter 118 passes through a hole 134 in the distal end of the end effector 106 and is fixedly attached to the more proximal portion of the end effector, as shown in fig. 8, to form an expandable and retractable cutter.

Fig. 6-8 illustrate longitudinal cross-sectional views of a cavity-forming instrument 100 of the vertebral cavity formation and fracture reduction system and method. Fig. 7 shows a more detailed view of the handle 102. Fig. 8 shows a more detailed view of the end effector 106. Referring to fig. 6 and 7, fig. 6 and 7 illustrate a central passage 126 extending along a centerline a-a within the body 108 of the handle 102. The proximal end of the insertion tube 104 is secured within this passage 126 such that the insertion tube 104 and the passage 126 are coaxial. The shaft 128 is configured to extend from the connector of the rotating component 114, through the lumen of the insertion tube 104 to the connector at the coupling member 132, wherein the coupling member 132 is coupled to the distal portion 124 of the end effector 106.

Referring to fig. 7, the shaft 128 is coupled with the rotating component 114 such that rotation of the rotating component 114 correspondingly rotates the shaft 128 and the distal portion 124 of the connected end effector 106. Thus, the rotating component 114 is used to rotate the end effector 106 and the cutter 118 relative to the insertion tube 104. In the illustrated version, the rotational component 114 and the shaft 128 are not coupled for axial translation, but only rotational movement, wherein axial translation of the shaft 128 is independent of the operation of the rotational component 114. The rotating component 114 is used to rotate the end effector 106 when the cutter 118 is expanded to rotationally cut tissue to form a tissue cavity, e.g., entirely within a vertebra.

Referring to FIG. 7, intermediate rotary member 112 is coupled to shaft 128 to facilitate expansion and contraction of cutter 118 through aperture 134. Rotary component 112 is threadably engaged with shaft 128 in a jack screw configuration such that rotational movement of rotary component 112 is translated into axial movement of shaft 128. Shaft 128 is free to rotate relative to rotational component 112 such that only axial motion, and no rotational articulation, is transferred to shaft 128 through rotational component 112. As previously discussed, the rotation of the shaft 128 may be controlled solely by the proximal rotational component 114. In the illustrated version, rotation and axial translation of the shaft 128 are distinct and separate manipulations by independent mechanisms to make the cavity-forming instrument 100 flexible to operate.

Referring to FIG. 8, axial translation of shaft 128 causes coupling member 132 to advance the proximal end of cutter 118 in a corresponding proximal or distal direction. Such as by rotating the rotary member 112 in a first direction to translate the shaft 128 in a distal direction, thereby urging the cutter 118 against the seat 138 and outwardly through the aperture 134, thus expanding the cutter outwardly to increase the cutting radius. Such as by rotating the rotary member 112 in a second direction to translate the shaft 128 in a proximal direction, thereby pushing the cutter 118 to retract through the aperture 134 and against the transverse member, thus reducing the cutting radius. The rotating component 112 shown in FIG. 7 can be used to adjust the cutting radius of the cavity forming instrument 100 to a desired radius prior to rotating the cutter 118 to form a cavity. In the alternative, the cutter 118 can be expanded or contracted while rotating the end effector 106 to form the cavity.

Referring to FIG. 7, the distal rotation member 110 is coupled to the articulation drive member 130 to facilitate articulation of the end effector from the first axis A-A to the second axis B-B, as shown in FIG. 9. The rotary member 110 is threadedly engaged with the driving member 130 in a jack-up screw structure such that the rotary motion of the rotary member 110 is converted into axial movement of the driving member 130. The distal end of the drive member 130 is attached to the proximal portion 122 of the end effector 106 with a pin 136, as shown in fig. 8. Pulling the drive member 130 and pin 136 proximally causes the end effector 106 to rotate about the pivot pin 116. Articulating the end effector 106 in this manner enables the end effector to be positioned along a second linear axis B-B offset from the first linear axis a-a as shown in fig. 9. When in the offset position, cutter 118 may be expanded by rotating component 112 and rotated by rotating component 114 to increase the void volume. By pushing the drive member 130 and pin 136 distally, the end effector 106 is realigned with the first linear axis a-a.

Fig. 9 shows a longitudinal cross-sectional view of the end effector 106 shown in the articulated position with the cutter 118 expanded. The end effector 106 is articulated into alignment with the second linear axis B-B by axially translating the drive member 130 and rotating the end effector 106 about the pivot pin 116. The articulation of the end effector 106 may occur at any suitable articulation region or articulation point, such as, for example, a pivot pin 116, a gear articulation region, a hinge, a metal hinge, a plastic, a flexible member, a living hinge of a flexible material, a shape memory alloy articulation region, or a combination thereof. One or more hinge regions or points, such as pivot pins 116, may be provided for hinging about multiple planes and/or axes. The articulation may be mechanical, for example, achieved with a pivot pin or gear arrangement in a manner that excludes flexible or living hinge components at the hinge point or region. As in the illustrated version, member 130 is driven in proximal or distal translation by rotating rotational member 110. After the shaft 128 is pushed distally by the rotating rotary member 112, the cutter 118 is shown in the expanded position. In the position shown in fig. 9, the distal portion 124 of the end effector 106 is rotated about the second linear axis B-B to form a hollow portion.

The articulation of the end effector 106 serves to form a biased hollow portion while the insertion tube 104 remains aligned with the first linear axis a-a. The offset hollow portion of the intervertebral cavity facilitates the centering of the balloon 212, which may be advantageous in some circumstances. For example, depending on the geometry of the bone, an offset cavity may be useful in forming an anchor to provide greater torque in an asymmetric cavity, forming an undercut, or in order to access a region of the bone that is offset from the entry point. Forming offset voids can be used to form larger voids. In general, the extent and entrance of the cavity may be increased by allowing instruments to be inserted through a relatively small entry point.

Referring to fig. 10, fig. 10 illustrates one version of a vertebral fracture reduction device 200 for a vertebral cavity formation and fracture reduction system. The vertebral fracture reduction device 200 is approximately 32cm long and generally comprises: a series of flexible access ports 202, 204, and 206, an access port housing 208, an insertion sheath 210, a central compound lumen 218, side lumens 220, an expandable member or balloon 212, and a feeding tentacle 214. The device 200 is configured for insertion into a cut vertebral cavity in a reduced configuration and expansion within the cavity to reduce a compression fracture of the vertebra. Once the fracture is reduced, the device 200 is configured to deliver bone cement into the vertebral cavity to restore the integrity of the vertebrae. Any suitable size may be provided, wherein, for example, device 200 may be long enough to reach the target site without interfering with fluoroscopy.

Fig. 11 illustrates a longitudinal cross-sectional view of a vertebral fracture reduction device 200 of the vertebral cavity formation and fracture reduction system. Fig. 12 shows a more detailed view of the handle access ports 202, 204, 206 and the access port housing 208. Fig. 13 shows a more detailed view of the bladder 212 and the feeding tentacle 214. FIG. 14 is a cross-sectional view of the feeding lumen and the insertion sheath. Referring to fig. 11 and 12, the aligned access ports 202, 204, 206 have a coplanar orientation and each include a luer connection configured to engage a single-plunger delivery syringe (single-plunger delivery syringe). Inlet ports 202 and 204 are coupled to central compound chamber 218 and inlet ports 206 are coupled to side chambers 220. Any suitable type or number of inlets may be provided, for example, the inlets may be configured to prevent inadvertent improper use of syringes or applicators having color markings, different sizes, different connectors, etc. Any suitable delivery device may be used, including syringes, or screw-type plungers, push-type plungers, pistol-type plungers, pressurizing devices, motorized pumps, and the like.

Referring to figures 10 and 11, in the illustrated version, the central compound lumen 218 is an elongated, semi-rigid cylinder extruded with bismuth (a radiopaque additive) to facilitate visualization during surgery. The compound chamber 218 is coupled to the access ports 202 and 204 and extends from the housing 208 through the bladder 212 and distally out of the end of the bladder. The compound lumen 218 through the bladder 212 may also be considered a form of tentacle for delivering flowable material. In the illustrated version, compound lumen 218 is non-linear and has a substantially S-shaped or curved distal end about which bladder 212 is mounted. A substantially linear pattern or other orientation of compound cavity 218 is also contemplated. Referring specifically to the cross-sectional view of FIG. 14, the compound chamber 218 includes a saline supply chamber 222 and a parallel configuration cement supply chamber 224. The saline supply lumen 222 is fused at or near the distal end and includes one or more apertures 216 in fluid communication with the lumen of the balloon 212. The saline supply lumen 222 provides fluid communication between the access port 202 and the balloon 212 such that saline supplied enters through the access port 202, fills, and expands the balloon 212. Likewise, saline drawn through access port 202 correspondingly deflates balloon 212. In the illustrated version, saline fed into the balloon 212 through the access port 202 is used only for balloon inflation and is not released to the vertebrae or any other part of the body. Saline may be released or provided into the vertebral body, for example, to aid in the washing of cancellous bone from the cortical wall.

Although inflation of the bladder 212 is described in terms of saline, it should be understood that any suitable flowable material or fluid, including air or gas, may be used to inflate and/or deflate the bladder 212. For example, bone cement, biological materials, bone growth materials, bone chips, bone pastes, bone gels, saline mixed with radiopaque additives, pressurized air, or combinations thereof may be used. The balloon 212 may be non-porous, semi-porous, or porous, wherein, for example, a porous balloon filled with bone cement may exude bone cement into the vertebral cavity during expansion.

It should be appreciated that multiple chambers 218 may have any suitable configuration and any suitable number of fully or partially through chambers. Multiple cavity 218 may extend through bladder 212 as shown, or alternatively, multiple cavity 218 may be adjacent to or separate from bladder 212. The saline supply chamber 222 and the cement supply chamber 224 may be configured as separate chambers that are not retained within a single compound chamber 218. In general, all lumens may be single lumen or multi-lumen tubes, wherein a multi-lumen tube may have the advantage of a reduced inner diameter due to the common walls. Additional lumens may be provided, for example, for aspiration, irrigation, guide wire, additional expandable members or expansion of the cement container, or for tamponade.

Still referring to fig. 10, 11 and 14, the cement delivery lumen 224 extends along the length of the duplex lumen 218 and terminates in a distal bore 226 at the distal end of the reduction device 200. The cement supply lumen 224 is in fluid communication with the inlet port 204 such that cement supplied through the inlet port 204 exits the device 200 at the distal aperture 226. The access port 204 and the cement delivery lumen 224 are configured to deliver bone cement, or any other suitable material, through the reduction device 200 into the vertebral body cavity, for example, to restore the strength of the vertebrae after fracture reduction. In the illustrated version, the access port 204 and cement delivery lumen 224 are configured in such a way that instruments such as a tamping instrument cannot be inserted into the lumen 224; it should be understood that the access port may be configured to receive a tamping instrument or the like to facilitate expulsion of material from the cavity, to fill the vertebral body with material, and/or to cover (capping) the entry point of the vertebra after insertion of the filler material. It is also contemplated to provide separate access ports configured to receive a tamping instrument, a covering instrument, or a filling instrument.

Referring to fig. 10 and 11, in one aspect, side lumen 220 is an elongated PET tube in fluid communication with inlet port 206, which terminates in supply tentacle 214. In the illustrated version, a single supply tentacle 214 made of PET is integral with and in fluid communication with the side cavity 220. With particular reference to the cross-sectional view of FIG. 14, the side chamber 220 may be bonded to the manifold 218 and bladder 212 with a UV-cured adhesive, wherein both the manifold 218 and the side chamber 220 may be surrounded by an elongated sheath 210, the sheath 210 extending from the housing 208 to proximate the bladder 212. Multiple lumen 218 may be bonded to sheath 210 with cyanoacrylate. The supply tentacles 214 may be part of a side lumen 220 extending from the sheath 210, and the supply tentacles 214 may be bonded to the anterior side of the outer surface of the balloon 212 with a UV-curable adhesive. The delivery tentacle 214 includes a plurality of holes spaced along the length of the tentacle through which cement may be delivered into the vertebral cavity.

It should be appreciated that the illustrated lumens 218, 220 may be bonded or held with any suitable means, such as the illustrated sheath 210, or any suitable adhesive. The feeding tentacle 214 and the lateral cavity 220 may be a continuous structure as shown, or alternatively, the feeding tentacle may be separate components that are secured, connected, or attached to the lateral cavity 220. The lateral cavity 220 may be rigid and the tentacle 214 may be flexible, both flexible, or both rigid or semi-rigid. The delivery tentacles 214 also include one or more tentacles having any suitable configuration for delivering bone cement, dyes, gases, fillers, therapeutic agents, drugs, and/or any suitable material. The delivery tentacle 214 may have one or more holes and/or may be constructed of a porous material for delivering fluid to the vertebrae.

Referring to fig. 10, 11 and 13, in the illustrated version, the balloon 212 is a non-porous PET structure having a substantially uniform wall thickness disposed near the distal end of the vertebral fracture reduction device 200. The bladder 212 is coated with urethane and tungsten powder. Each end of the bladder 212 is bonded to the manifold 218 to form a fluid-tight seal during inflation. The bladder 212 is taped to the manifold at a length at each end to help maintain the integrity of the bond during inflation. The illustrated bladder 212 has a non-axisymmetric configuration and is not aligned about any straight axis. The bladder 212 forms a single lumen and is not divided into compartments. In the illustrated version, the balloon 212 does not have any internal or external constraints that limit balloon inflation. The proximal and distal regions of the balloon 212 have a greater width than the central portion of the balloon 212, and each end region tapers toward a connection with the compound lumen 212. The balloon 212 is configured to be in fluid communication with the access port 202 and the saline supply lumen 222 such that the balloon 212 may be inflated to reduce vertebral fracture when inflated against the cortical bone endplate.

The bladder 212 may have any suitable features or elements to retain, shape, or form the bladder 212 including, for example, internal constraints, external constraints, varying wall thicknesses, bands, and/or varying materials. Although the bladder 212 is shown in a non-axially symmetric form, the bladder may have an axially symmetric structure, or other shape, and may be aligned along a linear axis. The ends of the bladder 212 may taper as shown, or may be inverted, or have any other suitable configuration. It is also contemplated to provide the balloon with a uniform diameter along its length. Any suitable partial or complete coating in one or more layers may be utilized, including smooth, rough coatings for wound application, radio opaque, anti-bone growth, non-adhesive, barium, bismuth, PET-embedded materials, tungsten powder, tantalum, or combinations thereof. In addition, radiopaque coatings may be masked in certain portions to aid in viewing, measuring wounds, replacement, guidance, and the like. Any suitable area, band, structure, marking, indicia, or writing may be masked or otherwise indicated for viewing.

Referring to fig. 15, fig. 15 shows one version of a method 300 for a vertebral cavity formation and fracture reduction system. The method includes a step S301 of providing a trocar and cannula assembly, including, for example, providing the trocar and cannula assembly 10 described with reference to FIGS. 1-3. The method 300 includes a step S302 of accessing a vertebral body with a trocar and cannula assembly. Step S302 includes making a small incision in the patient' S skin and inserting the trocar and cannula assembly 10 through the skin and adjacent the fractured vertebrae using, for example, a transpedicular approach, a posterolateral approach, or a transsacral axial foramina approach. The first penetration member 24 of the trocar 12 is initially introduced into the vertebra, for example, through the root (pedicle) or cortical bone. The first penetration member 24 is configured with a small point at the distal end to facilitate entry of the trocar 12 into the root or other site, for repositioning if desired, and to control the positioning of the trocar. The small point of the first penetration member 24 is used to penetrate the root until the second penetration member 26 abuts the root. A second, larger diameter penetrating member 26 is then drilled into the root to create a sufficiently large entry point for insertion of cannula 14. After the entry point is created with the trocar 12, the cannula 14 remains within the entry point to function as an instrument guide during surgery. Step 301-303 is described with reference to the combined trocar and cannula assembly 10; it should be understood, however, that any suitable trocar and/or cannula may be used in accordance with the teachings herein.

With the cannula 14 in place, the method 300 includes the step 303 of removing the trocar 12 from the cannula, which includes withdrawing the trocar 12 proximally from the cannula by separating the two-piece handle 16 and withdrawing the removable first handle portion 18. The handle portion 18 is removed and the attached trocar 12 is removed from the lumen of the cannula 14, leaving a cavity through which the drilling tool 40 shown in FIG. 4, the cavity-forming instrument 100 shown in FIG. 5, the vertebral fracture reduction device 200 shown in FIG. 10, and/or any other suitable instrument may be inserted. When the trocar 12 is removed, the cannula 14 remains in place within the vertebrae and the cannula 14 will remain in this position during the procedure. Other instruments that may be inserted include spare cement supply tubes, suction devices, biopsy devices, cameras, visualization devices, bone extractors, or cement plugs.

The step 304 of providing a drilling tool includes providing a passage forming instrument such as the drilling tool 40 described with reference to fig. 4. The step 305 of drilling an access passage in the cancellous bone of the vertebra includes inserting a passage forming instrument or drill 40 into the cannula 14 until the drill 40 abuts the vertebra. Then, in one version, the drill bit 46 of the drill 40 is manually rotated to form a substantially straight cylindrical passage into the cancellous bone of the vertebra, up to the anterior cortex. The depth of the channel is measured with markings 50 on the body 42 of the drill 40 to guide the surgeon in controlling the formation of the channel. In one version, the grip 44 of the drill 40 extending proximally from the second grip portion 20 of the cannula 14 is manually rotated by the physician's hand via the grip 48 to form the desired passageway. Step 305 also includes removing the drilling tool 40 from the cannula 14 after forming the channel. It should be understood that manual operation of the various instruments described herein may be performed using motors or other suitable electrical or mechanical devices.

The step 306 of providing a cutting instrument includes providing a cavity-forming instrument or device, such as the cavity-shaped instrument 100 described with reference to fig. 5-9. Positioning 307 the cutting instrument within the access channel includes inserting the cavity-forming instrument 100 through the lumen of the cannula 14 and into the channel formed by the drilling tool 40. During insertion, the cavity-forming instrument 100 is maintained in a straight position with the end effector 106 aligned with the first straight line axis A-A. The flexible cutting element 118 is in a fully retracted position during insertion to minimize the width of the end effector 106. The depth and displacement of the cavitation instrument 100 may be monitored via fluoroscopy, along with depth markers, to properly position the end effector 106 within the access channel of the vertebra. In one version, the end effector is positioned such that it is entirely within the cancellous bone volume of a single vertebra. It should be understood that the methods described herein may also be used for the formation of tissue cavities, orthopedic cavity formation, spinal cavity formation, vertebral cavity formation, discectomy, or other orthopedic or medical procedures.

The step 308 of laterally expanding the flexible cutting element of the cutting instrument includes laterally expanding the cutter 118 from the end effector 106. In one aspect, the cutter 118 is expanded by manually rotating the rotary member 112 in a first direction. Rotating member 112 is manually rotated like a jack screw is operated to distally urge shaft 128. Distal translation of shaft 128, which is connected to cutter 118 via coupling member 132, pushes cutter 118 outwardly through aperture 134. In the illustrated version, because one end of the cutter 118 is fixed to the proximal portion of the end effector 106, the cutter 118 expands outward to form an arcuate shape as the shaft 128 is pushed distally. Step 308 includes laterally expanding the arcuate shape of the cutter 118 a desired distance, either fluoroscopic or resistance from the access channel.

The step 309 of cutting the cavity portion of the first vertebra includes forming a cavity in cancellous bone of the vertebra using the cutting instrument 100. After the partial lateral expansion step 308 of the cutter 118, the end effector 106 may be rotated about the first linear axis AA to cut cancellous bone tissue. In one version, the cavity is formed by manually rotating the rotating member 114, rotating the rotating member 114 correspondingly rotates the shaft 128 and end effector 106 to cut into cancellous bone. The void formation step 309 may be generally axially symmetric about the linear axis a-a. The void may have a width greater than the drilled access channel. In one version, steps 308, 309 are performed simultaneously to expand the cutting element 118 while rotating the end effector 106 to form the cavity. Although described with reference to forming vertebral cavities, it should be understood that the cavity-forming devices described according to the methods herein may be used in any suitable orthopedic or medical application, such as, for example, forming cavities in long bones, or for plaque (plaque) removal in cardiovascular applications. Other uses include spinal disc applications, neurosurgery, interventional radiology, and pain control.

Step 309 also includes incrementally expanding the cutter 118 laterally to form an expanding cavity. Cutter 118 may be expanded as described with reference to step 308, cutter 118 being used to cut a portion of the cavity as described above. In one version, the cutters 118 are then progressively radially outwardly expanded by rotating the rotary member 112. The rotating member 114 is then rotated to form the expanding cavities. Increasing the expansion of cutter 118 then creates a void through rotating component 114, which is repeated a sufficient number of times to create the desired void. The appropriate cavity size is determined by fluoroscopy. During cavity formation, as cancellous bone is cut, the cut cancellous bone can be collected together, or can collect within the vertebrae, it can compact against cortical walls, and/or it can be removed from the vertebrae. A suction device may be provided to remove bone debris and/or a compaction device may be provided to compact bone against the cortical wall to remove cancellous bone from the cavity.

The step 310 of articulating the distal end of the cutting instrument includes articulating the end effector 106 of the cutting instrument 100 within the hollow formed according to step 309 such that it is offset from the first linear axis a-a. The end effector may be offset such that it is aligned with a second linear axis, such as axis B-B. The articulation may occur at one or more articulation points or areas, and the end effector 106 may be articulated such that it is offset a first distance from the axis a-a, for example. The first distance may be achieved by pivoting the end effector 106, bending the end effector 106, or articulating the end effector 106 such that it is offset, pivoted, or spaced from the axis a-a. Step 310 includes partially retracting the cutter 118 so that it is adjacent to the end effector 106 prior to articulation. The end effector 106 may then be articulated by rotating the distal rotation component 110 in a first direction as described herein.

In one version, articulation according to step 310 is accomplished by increasing articulation of the end effector 106 toward the opposite side of the intervertebral space of the vertebral bodies. The rotary member 110 is rotated in a first direction to push the end effector 106 such that its offset from the first linear axis a-a increases. The rotating member 114 is then rotated to increase the size of the hollow to provide more room for articulation of the end effector 106. The rotation component 110 is again rotated in the first direction to further increase the articulation of the end effector 106 before the end effector is again rotated via the rotation component 114. Increasing the articulation of the end effector 106 then creates a void through the rotating component 114, which is repeated as many times as necessary until the end effector 106 is sufficiently articulated. Alternatively, the rotation and articulation may be accomplished simultaneously. The end effector 106 is suitably guided to a central position by the surgeon via fluoroscopy. Articulating the end effector 106 toward the opposite side of the vertebral body may create a void exposing the cortical endplate to directly contact the balloon 212 during expansion of the balloon 212 to reduce a compression fracture of the vertebra. After positioning, the end effector 106 may be aligned along a second linear axis B-B that is at an angle to the first linear axis A-A of the insertion tube 104.

Step 311 of cutting the second vertebral cavity portion includes expanding the cavity portion formed according to step 309, for example, to expose an area of cortical bone within the intervertebral space. In one version, a second hollow portion is formed by laterally expanding cutter 118 and rotating cutter 118 in a stepwise manner as described in accordance with steps 308 and 309 to expose the endplates of the vertebrae. Alternatively, these may be performed simultaneously. As with steps 308 and 309, the cutter 118 may be guided by fluoroscopy. In particular, the formation of the second void portion may form a central void of the endplate exposing cortical bone of the vertebra, which serves as a basis for the expansion of the fracture reduction balloon 212.

In one version, the cutter 118 may form a pocket in the cancellous bone adjacent the anterior wall of the vertebral body when the endplates are exposed. When a fracture reduction procedure is performed with the patient lying face down, there is a natural tendency for the cut cancellous bone to be drawn from the intervertebral space into the anterior cavity of the cavity. In this manner, the anterior cavity of the cavity may serve as a receptacle for cancellous bone, such that the endplates may be accessed without bone compaction or removal. Step 311 includes cutting cancellous bone from the endplates of the vertebrae, and collecting the cut cancellous bone in the anterior cavity of the void. Cutting away cancellous bone, rather than compacting it, provides an exposed cortical surface that is more sensitive to more predictable compressive forces. Removing as much cancellous bone as possible from the vertebral bodies adjacent to the endplates may increase the predictability and control of the procedure.

Although a method of cutting and collecting cancellous bone is described, it should be understood that cancellous bone may be removed, pooled, compressed, and/or compacted to form a void or cavity portion according to the protocols herein. For example, cutting away a portion of cancellous bone and then compacting a thin region of cancellous bone may be used as a seal within a vertebral body to prevent leakage of bone cement or other fluids. By cutting away a first portion of cancellous bone prior to compacting a second region of cancellous bone, a sufficient amount of cancellous bone can be removed so that the fracture reduction device is sufficiently close to the cortical bone of the vertebra to effectively reduce the fracture. Thus, a variety of methods may be incorporated in forming the desired voids. Multiple access ports, cuts, plugs, compactions, restrictions, cures, removals, aspirations, and/or dilators may be inserted or used in any suitable manner or order.

The step 312 of articulating the distal end of the cutting instrument includes articulating the end effector 106 of the cutting instrument 100 in a return direction until it is linearly aligned with the first linear axis a-a. By rotating the distal rotation component 110 in the second direction, the end effector 106 is hingedly aligned. In this manner, cutting instrument 100 may return to its pre-insertion, straight configuration such that it can be easily removed through cannula 14. The step 313 of retracting the flexible cutting element includes retracting the cutter 118 through the aperture 134 by rotating the rotary member 112 in the second direction. In this manner, cutter 118 returns to its pre-insertion collapsed configuration so that it can be easily removed through cannula 14. The step 314 of removing the cutting instrument through the cannula includes removing the cutting instrument 100 through the cannula after the cutter 118 has been retracted and the end effector 106 has been linearly aligned with the insertion tube 104. In one version, the cannula 104 is left in place during all steps in which the cutting instrument 100 is used. It should be appreciated that any suitable number of cutting instruments having any suitable configuration may be inserted through cannula 14. For example, void-forming devices having multiple hinges or joints and/or varying angles of hinges may be used. Although the end effector 106 is described as maintaining a substantially linear configuration, it should be appreciated that the end effector 106 may have any suitable shape, such as a curvilinear shape, or may be deformable, such as, for example, from a substantially linear shape to a curvilinear shape if made from a shape memory alloy, such as nitinol.

Step 315 of providing a fracture reduction device includes providing a fracture reduction device such as fracture reduction device 200 described with reference to fig. 10-14. It should be appreciated that step 315 is described with reference to vertebral fracture reduction by way of example only, and may be used for any suitable tissue application. Positioning the fracture reduction device within the void step 316 includes inserting the fracture reduction instrument 200 through the lumen of the cannula 14 into the void formed, for example, with the cutting instrument 100. Prior to insertion, the bladder 212 may be pleated and folded in a folder, or in other words have a reduced size. The folder includes two separate sets of jaws, each set including a plurality of fingers, wherein a first set of jaws heats and pleats the bladder 212, and a second set of jaws folds the bladder 212 by wrapping it around a central lumen 218. During insertion, the fracture reduction device 200 is maintained in a reduced position such that the width of the bladder 212 is minimized during insertion. In one aspect, the flexibility of the tentacles 214 during insertion can reduce the diameter of the tentacles 214 to be inserted through a relatively narrow access channel. After insertion, the flexibility of the tentacles 214 enables the tentacles 214 to expand significantly. The displacement and depth of the fracture reduction device 200 is monitored via fluoroscopy, along with depth markers, to properly position the balloon 212 within the vertebral cavity.

After insertion of the fracture reduction instrument, the substantially S-shaped or curvilinear distal end of compound lumen 218 shown in the illustrated version extends into the vertebral cavity such that balloon 212 is centrally disposed within the cavity. In one version, the balloon 212 is positioned such that, when expanded, the balloon walls press against the endplates of the exposed vertebrae after the cancellous bone has been removed. Other protocols may compact a large or minimal amount of cancellous bone. The bladder 212 may be constructed of flexible, but substantially inelastic PET such that the bladder 212 only expands to a predetermined shape regardless of the magnitude of the expansion pressure. The balloon 212 may be configured to expand against the cortical endplates to reduce vertebral fractures, but not through the anterior cavity of a void in which cancellous bone may collect. Thus, in one version, the vertebral endplates are expanded to reduce the vertebral fracture without compacting or removing cancellous bone. Alternative protocols may include removing and/or compacting cancellous bone.

Step 317 of expanding the fracture reduction device to reduce the fracture includes expanding the fracture reduction member 200, such as to the exposed endplates of the vertebrae, to reduce the fracture. In one version, the balloon 212 is uniformly inflated by introducing a flowable material, such as saline, through the access port 202. In one version, the flexible but inelastic PET balloon 212 is configured to expand to the endplates of the vertebrae without expanding to fill the entire void. In this manner, the fracture is reduced without compacting bone remaining in the anterior cavity of the cavity. After being positioned adjacent the endplates of the vertebrae according to step 316, the balloon 212 is inflated using a syringe to introduce saline solution through the access port 202 and the saline supply lumen 222. The inflation of the bladder 212 corresponds to the volume of saline supplied by the syringe. The surgeon determines adequate expansion by observing the fracture reduction device 200 under fluoroscopy and by monitoring the pressure gauge. In the illustrated version, because the bladder 212 is constructed of flexible but substantially inelastic PET, the bladder only expands to its predetermined shape, regardless of the magnitude of the inflation pressure. The balloon 212 is configured to expand against the cortical bone endplates to reduce the fracture, but not through the anterior cavity of the void in which cancellous bone is collected. Thus, in one version, the vertebral endplates are expanded to reduce the fracture without compacting or removing cancellous bone.

It should be appreciated that bladder 212 may alternatively have an elastic structure configured to substantially fill the void, an internal or external constraint forming the shape of the bladder, any suitable shape, any suitable radiopaque marker, any suitable surface effect or coating, any suitable number of chambers, compartments, or layers, and/or any suitable material combination or wall thickness. Although the balloon 212 has been described with reference to a vertebral fracture reduction procedure, it should be understood that the methods described herein may be used in other medical procedures such as orthopedic or cardiovascular applications. The balloon 212 may be used to compact cancellous bone to form a cavity and/or to form a seal around cortical bone to prevent bone cement or fluid leakage. The balloon 212 may be filled or inflated with any suitable material, such as saline, bone cement, gas, dye, and/or any other fluid, and may have a porous or non-porous surface. In one version, the balloon 212 is permanently implantable, e.g., the balloon is inflated with bone cement and left in the vertebra.

Step 318 of delivering bone cement into the cavity includes delivering any suitable flowable material, such as bone cement, fluid, air, gas, medicament, bone paste, bone chips, bone growth agent, etc., through cement delivery lumen 224 and delivery tentacles 214 via access ports 204 and 206, respectively. Flowable material is supplied through inlet ports 204 and 206 using a manually pushed syringe. After the step 317 of inflating the bladder 212, flowable material is supplied through the tentacles 214 to fill a portion of the void. When the cavity is filled with bone cement or any other suitable flowable material, the balloon 212 may be gradually deflated according to step 319 to enable the bone cement delivered through the cement delivery lumen 224 to fill the void in the intervertebral space. The bone cement delivered through the tentacles 214 may be fully cured or only partially cured prior to delivery of the cement through the delivery lumen 224. In one version, the flowable material may be delivered via the cement delivery lumen 224 and/or the delivery tentacles 214 prior to inflation of the balloon 212, wherein, for example, bone cement may be delivered via the delivery tentacles 214 prior to inflation of the balloon 212, and upon inflation, the bone cement is advanced into any cracks that may occur in cortical bone.

Step 318 also includes delivering a plurality of successive layers of material, such as bone cement, to the inner surface of the vertebral cavity. For example, a layer of bone cement may be supplied through tentacles 214 and allowed to cure for a predetermined period of time. Multiple successive layers of bone cement, therapeutic material, fluid, etc. may then be delivered within the vertebral cavity. One or more layers or coatings may be delivered with the fracture reduction element 200 and/or other delivery instruments.

The step 319 of reducing the fracture reduction device includes partially reducing the fracture reduction device 200 so that bone cement can be delivered into the cavity. The balloon 212 of the fracture reduction device 200 is deflated by withdrawing a syringe coupled to the access port 202 to draw fluid out of the balloon 212. Draining the fluid with the syringe reduces the volume of saline in the bladder and creates a vacuum within the bladder, which aids in deflation. Step 319 also includes sufficiently shrinking the balloon after a sufficient amount of bone cement has been delivered according to step 319. Step 319 also includes mechanically winding the bladder 212.

The cannulation removal of the fracture reduction device step 320 includes removing the fracture reduction device 200 after the balloon 212 has been sufficiently deflated and the cavity has been filled with bone cement. After the balloon 212 is substantially removed from the vertebra, bone cement is delivered through the cement delivery lumen 224 to fill the cavity. In this manner, bone cement can fill the void while the vertebrae are compressed outwardly to effect fracture reduction of the vertebrae with the cement. The fracture reduction device 200 is then removed through the cannula 14. The cannula removing step 321 includes removing the cannula 14 from the vertebral body after the vertebral fracture has been reduced and bone cement is injected. Step 321 includes removing cannula 14 from the patient. Step 321 may also include inserting a plug device through the cannula 14 prior to removing the cannula, which prevents bone cement or filler material from escaping from the vertebral cavity before curing begins. After the material is partially cured, the obturator instrument and cannula 14 may be removed.

Fig. 16-24 illustrate an alternative to the end effector 106 of the cutting instrument 100 illustrated in fig. 5-7 and 9, which utilizes a generally band-shaped cutting element. An alternative approach described herein utilizes a shape-changing cutting element configured to form or modify a cavity in hard or soft tissue, including, for example, cancellous bone within a vertebra. The shape-changing behavior enables the cutting instrument 100 to be inserted into tissue through a relatively small access opening to form a tissue cavity having a diameter larger than the diameter of the access point. Thus, the approaches described herein may be particularly useful in minimally invasive surgery and may be used for at least the following specialized purposes, including: (1) treating or preventing bone fractures, (2) arthrodesis, (3) graft fixation, (4) tissue harvesting (particularly bone), (5) removal of diseased tissue (hard or soft tissue), (6) removal of general tissue (hard or soft tissue), (7) vertebroplasty, and (8) kyphoplasty. The tissue cavities formed according to the various aspects described herein may be of any suitable size, shape, or configuration, including spherical voids, hemispherical voids, linear voids, troughs, channels, voids with varying geometries, such as upper hemispherical chambers and lower linear voids, or any other suitable cavity configuration. Alternative articulation of the end effector 106 is used for various void configurations formed along multiple axes and/or planes.

Fig. 16 illustrates one version of an end effector 406 that may be used with the cutting device 100 shown in fig. 5, for example. It should be understood that the term "end effector" generally refers to the working end of the cutting instrument, or an identifiable component of the cutting instrument. For example, the end effector 406 may be coupled to the insertion tube 104 shown in FIG. 5, or may be a component of a continuous insertion tube. The end effector 406 includes: a shaft 428, a flexible cutting element 418, a cross member 416 such as a guide, pin or catch, and a transition member 432. In the illustrated version, the shaft 428 has a longitudinal axis A-A and a generally circular cross-section. It should be understood that any suitable cross-section, such as a substantially square cross-section, a substantially oval row cross-section, or a polygonal cross-section, is contemplated. In the illustrated version, the end effector 406 includes a hole 434 where the flexible cutting element 418 is configured to be at least partially seated or retained within the end effector 406.

In the illustrated version, the flexible cutting element 418 is formed of a flexible material, such as stainless steel, and the first end 422 is attached to the end effector 406 near the proximal end of the aperture 434. The second end 422 of the flexible cutting element 418 is coupled to a distal face of a transition member 432. The connection may be a laser weld or other suitable connection. The flexible cutting element 418 may be attached at or near the proximal end of the end effector 406, wherein a portion of the flexible cutting element 418 may be crimped under a proximal lip of the end effector 406, as shown with reference to the end effector 106 in fig. 9, to form a living hinge that relieves stresses on the flexible cutting element 418 when deformed. The flexible cutting element 418 may be a flexible band, cylinder, ribbon, serrated element, or have any other suitable configuration. The flexible cutting element 418 may have a uniform cross-section or a varying cross-section.

The transition member 432 is configured to translate along the a-a axis such that axial movement relative to the end effector 406 may be transmitted to the flexible cutting element 418 to laterally extend the flexible cutting element 418 through the aperture 434. The transition member 432 may slide along the guide track 426 of the end effector 406 such that rotational movement of the transition member 432 relative to the end effector 406 is limited. For example, referring to fig. 18, which is a transverse cross-sectional view of the end effector 406 taken along line 3-3, the transition member 432 may have a wide bottom 436 to prevent such rotation. The transition member 432 may have any suitable shape configured to limit rotational movement relative to the end effector 406 while allowing axial movement such that the flexible cutting element 418 may deform or laterally expand.

Still referring to fig. 16, the shaft 428 is distally connected to a proximal face of the transition member 432 and proximally connected to an actuator, such as the actuator described with reference to the cutting device 100 shown in fig. 5-9. The shaft 428 is configured to actuate the transition member 432 proximally and distally to deform the flexible cutting element 418. Rigid or flexible shaft 428 may extend along axis a-a and may be fixedly connected with transition member 432. At the proximal end, the shaft 428 may be coupled to any suitable actuator configured to provide axial movement, such as the actuator or actuating mechanism disclosed in co-pending U.S. patent application 11/600313, the entire contents of which are incorporated herein by reference. Such actuators may include knobs, sliders, T-rails, spool valves, gear assemblies, triggers, manual actuation, electrical actuation, and the like.

In FIG. 16, the flexible cutting element 418 is shown in an expanded position, configured to form a cavity within, for example, cancellous bone of a vertebra. The expanded position may be created by actuating the shaft 428 distally with an actuator such that the transition member 432 pushes the flexible cutting element 418 against a ramped or inclined portion 430 integral with the end effector 406. The angled portion 430 may be integrally formed with the end effector 406, may be an insert, or may be suitably configured to direct the flexible cutter 418 laterally through the aperture 434 when a compressive force is applied along axis a-a. When the shaft 428 is actuated axially, generally in the distal direction, the flexible cutting element 418 will correspondingly deform laterally through the aperture 434. Transition member 432 may be actuated distally until abutting stop 435 along rail 426.

In one version, the flexible cutting element 418 is configured to expand from the proximal end to or beyond the distal end of the end effector 406, wherein the working length of the cutting element 418 may comprise substantially the entire length of the end effector 406. A long working length may increase the cutting effectiveness and efficiency of the cutting element 418. As shown in fig. 16, rolling or crimping one end of the flexible cutting element 418 around the proximal end of the end effector 406 may maximize the working length of the cutting element 418 while also providing a living hinge that biases the cutting element 418 outward. The flexible cutting element may also be crimped around a portion of the distal end of the end effector, as shown in fig. 23.

When partially or fully laterally expanded, the flexible cutting element 418 may be used to form a void by rotating the end effector 406. The end effector 406 may be rotated by a second actuation member, such as, for example, the rotating member 114 of the cutting device 100 shown in fig. 5. For example, the transition member 432 may be configured such that rotation is transferred to the end effector 406, wherein rotation of the transition member 432 correspondingly rotates the end effector 406 via the shaft 428. In this manner, shaft 428 may be used to deform flexible cutting element 418 and rotate flexible cutting element 418 to form a void. Rotational and axial movement of the elements of the cutting device 100 may be provided by one or more actuators as described herein.

Referring to fig. 17, the flexible cutting element 418 of the end effector 406 may be deformed to a contracted position for insertion into a guide hole in, for example, a vertebra, or for removal through a minimally invasive insertion site or cannula when a procedure such as that described with reference to fig. 15 is completed. In the retracted position, the shaft 428 and the transition member 432 are pushed in a generally proximal direction such that the flexible cutting element 418 is retracted through the aperture 434. In the illustrated version, the flexible cutting element 418 is pulled about the latch or cross member 416 to achieve substantially controlled and uniform retraction. When held against the cross-member 416, the flexible cutting element 418 may be stretched in the retracted position until the shaft 428 is actuated distally. In the illustrated version, the cross member 416 is a cylindrical rod that is fixed to both sides of the end effector 406 perpendicular to the axis A-A. The cross member 416 is configured such that a flexible cutting element 418 may slide thereabout. Cross-member 416 is one aspect of a latch that may have any suitable shape, wherein the cross-member need not be directly perpendicular to axis a-a. In particular, when configured as shown in fig. 8, the cross-member 416 may help prevent the cutting element 418 from buckling during actuation. In particular, the bottom curve of the transverse member may be resistant to bending.

19-20, FIGS. 19-20 illustrate an alternative to the end effector 506, in which the flexible cutting element 518 may be directly coupled to a shaft 528. The flexible cutting element 518 may be deformed as described above; however, the shaft 528 may rotate relative to the end effector 506. Rotation of the end effector 506 may be accomplished via the shaft 528 rotating the shaft 528 until the flexible cutting element abuts the aperture 534 and further rotation of the flexible cutting element correspondingly rotates the end effector 506. It should be appreciated that the flexible cutting element 518 may be continuous with the shaft 528.

Referring to fig. 21-22, fig. 21-22 illustrate in cross-section an alternative to the transition member taken along a line similar to line 3-3 of fig. 16. It should be appreciated that the version of the transition member described herein may have any suitable configuration, such as, for example, a toothed cylindrical transition member 550 guided within a corresponding keyway 552 of the end effector. As shown, the transition element 550 may be movable along a track within a chamber or cavity 554 that is separate from an adjacent chamber or cavity 556, which may serve, for example, as a suction or irrigation channel. Referring to fig. 22, the transition member may be a toothed, extended transition member 560 configured to slide within a corresponding channel 552. Any suitable slider or configuration for movement along the guide track is contemplated. It should be understood that the blade or cutting member may also be keyed or configured to move along a rail within the end effector.

23-24 illustrate an alternative with the end effector 606, wherein the shaft 628 actuates the transition member 632 proximally to expand the flexible cutting element 618 through an aperture 634 in the end effector 606. One end of the flexible cutting element 618 may be secured to the distal end of the end effector 606, while the other end may be connected to the transition member 632. Referring to FIG. 24, distal actuation of the transition member 632 pulls the flexible cutting element 618 into contact with the guide pin 616 or other limiting member, causing the flexible cutting element 618 to retract into the end effector 606. It should be understood that any suitable configuration utilizing guide pins or other guide members is contemplated. Such as changing the position of a guide pin or guide member toward the proximal or distal end of the bore, can change the arcuate shape of the flexible cutting element and provide various desired cutting shapes for medical procedures. As described herein, the end effector 606 may be articulated, actuated, and/or rotated by any suitable means, such as, for example, the cutting device 100 shown in fig. 5, a T-handle, or a power drill.

Versions of the flexible cutting element may have a bias toward a "memorized" shape, be made of a thermally responsive material, have a curvilinear shape when expanded, have a wave-like configuration when expanded, or may be otherwise suitably configured. The memory retention properties of many materials, such as nitinol or stainless steel, allow a wide range of configurations that can be expected. The shape may be determined or changed depending on the stiffness, material, temperature response, flexibility, and/or other properties of the provided cutting element.

For example, the first void portion may be formed with a flexible cutting element having a first configuration. After the first void portion is completed, the flexible cutting element may be altered, deformed, or transformed into a second configuration to alter or increase the size of the first void to form a second void. It is contemplated that the user may alternate between shapes, configurations, and orientations while forming the cavity without removing the cavity-forming device from the vertebral body. The configuration made of nitinol, for example, may be predetermined so that the user can select the shape to be expected from the options so that the user knows exactly which shape to use for cutting tissue. It will be appreciated that the shape may be a discretely selectable configuration, or in the alternative may be a plurality of points along the continuum that may be selected during or prior to the procedure. Providing multiple selectable configurations and/or enabling a user to adjust the configuration of the cutting element may allow for more precise formation or modification of the void.

The various versions of the flexible cutting element may be configured, articulated, or manipulated into any suitable shape, such as, for example, a circular arc shape, a plateau (plateau) shape, a curvilinear shape, a coiled shape, a helical shape, a laterally extending shape, a convex shape, a concave shape, a straight shape, and/or a sinusoidal or wavy shape. The shaft portion may be integral or continuous with the flexible cutting element, or may be a more clearly demarcated or discrete actuation feature associated with the flexible cutting element. The distal end of the flexible cutting element may be permanently secured to the insertion tube, such as with a laser weld, such that the distal end of the cutting element remains stationary while the shaft is stretched, rotated, compressed, articulated, and/or otherwise moved to change the flexible cutting element from the first shape to the second shape. The shaft and/or insertion tube may be rotated in a clockwise and/or counterclockwise direction to form or modify the desired cavity.

In addition to being rotatable or movable in one or more directions, the flexible cutting element may have one or more surface effects to create different cutting results. Multiple cutting edges or surface effects may be combined on a single flexible cutting element to affect tissue differently depending on the direction of cutting. The term "surface effect" refers to any geometry, feature, protrusion, texture, treatment, sharpening, tapering, material type, hardness, memory retention, heat treatment, thermal response, roughness, smoothness, sharpness, shape, and/or configuration of one or more surfaces, faces, edges, and points, etc., of the flexible cutting element or of any other component of the cavity-forming device. Any suitable surface effect member is contemplated, including but not limited to serrations, waves, convexity, concavity, edges, points, sharp edges, smooth edges, rough edges, flat edges, hardened edges, or combinations thereof. It is also contemplated that a first surface effect member may be provided on the first cutting surface of the flexible cutting element and a second surface effect member may be provided on the second cutting surface such that a change in direction of rotation changes the type of cutting or tissue effect.

Any suitable cross-section of the flexible cutting element may be provided, wherein varying the shape, size, and/or configuration of the shape flexible element may advantageously vary the cutting effect, stiffness, sharpness, and/or other properties of the flexible cutting element. It is to be understood that the illustrated aspects have been disclosed by way of example only, and not limitation. Varying the cross-section of the flexible cutting element along its length may provide beneficial tissue effects and/or may be structurally beneficial.

Referring to fig. 25-26, an alternative to an inflatable device is disclosed, such as may be used with the fracture reduction apparatus 200 shown in fig. 10, for example, in an orthopedic procedure for restoring diseased or fractured bone. Any suitable bone, such as a vertebra, may be prepared by providing a void therein according to the devices and methods described herein. Pre-existing cavities or pre-formed cavities, such as intrinsic cavities formed in bone, may also be utilized. As already discussed, an inflatable device such as a balloon may be inserted therein. Following introduction, the expandable device may be deployed and/or expanded by applying air, gas, fluid, liquid matrix, bone paste, bone cement, bone matrix, or the like, through a lumen fluidly connected thereto. The term "inflate" refers to expanding, increasing volume, swelling, expanding, and/or inflating with a fluid and/or gas. The expandable device may then be expanded within the bone marrow cavity, wherein one or more of the cavities applies outward pressure to the inner surface of the fractured bone.

The solution of an inflatable balloon is therefore particularly useful in minimally invasive surgery and can be used at least for the following specific purposes, in particular: (1) treating or preventing bone fractures, (2) arthrodesis, (3) graft fixation, (4) tissue harvesting (particularly bone), (5) removal of diseased tissue (hard or soft tissue), (6) removal of general tissue (hard or soft tissue), (7) vertebroplasty, and (8) kyphoplasty.

Referring to fig. 25, fig. 25 illustrates an expandable device 700 having a delivery lumen 712 connected thereto and a plurality of delivery lumens, tubes, tentacles, or protrusions 714, wherein the protrusions 714 are individually filled or expanded via the delivery lumen 716 independent of the expandable device 700 and are configured to deliver flowable material, bone cement, or other material through holes 718, holes, slits, apertures, or the like therein. In one version, the aperture 718 is configured to supply material to a predetermined location where a plurality of apertures and locations of the tentacle assist in supplying adhesive at a plurality of locations simultaneously along the front surface of the body. In this way, the flowable material can be supplied to a desired area, for example the front surface of the body, and can be guided away from a less desired area, such as for example the rear side of the body.

The tentacles or protrusions 714 may be made from any suitable material, such as a bladder material, a semi-rigid material, a short segment of rigid material, an adhesive material, a memory retention material, an adhesive material, a rigid material, an elastomeric material, and/or any other suitable material. Tentacles or protrusions 714 may be used to provide any suitable material, including the addition of adhesives, bone matrix, bone cement, synthetic pastes, therapeutic agents, restoratives, structuring agents, or other suitable materials, may aid or accelerate the restoration process, aid in properly mounting the capsule, provide stains or visible markings, etc., to visually identify the location of the capsule in the bone by scanning or X-ray, provide structural support, or for any other suitable purpose. Any number of compartments for any suitable purpose is contemplated. Then, to supply a particular material, the protrusion 714, tentacle, etc. may be pressed or sized via the associated cavity 716 to a desired pressure, size, configuration, shape, etc. Any suitable number of protrusions 714 may be used to supply material at any suitable location.

Tentacles or protrusions 714, including tubes, rigid tubes, semi-rigid tubes, lumens, flexible lumens, rods, spines, ridges, extensions, support members, combinations thereof, and the like, may be inserted, connected, secured, coupled to, or integrally formed with the expandable device 700 of the fracture reduction apparatus 200, such as shown in fig. 10, in a linear configuration, in a non-linear configuration, in a circular configuration, in a transverse configuration, in a longitudinal configuration, in a wave configuration, in a random configuration, in a non-linear configuration, in a helical configuration, and/or in any other suitable configuration. Tentacles or protrusions 714 may be attached to, for example, the inner or outer surface of the inflatable device. The supply of material may be independent of the inflatable device 700 or in combination with the inflatable device. Protrusions 714, etc. may extend in any suitable direction or in any suitable manner, such as outwardly from the inflatable device, or inwardly toward the center of mass (centroid) of bladder 700.

Further, tentacles or protrusions 714 may have multiple chambers, voids, cavities, tubes, etc. configured to perform various functions. The protrusion may comprise a porous outer surface connected to the supply chamber, wherein an adhesive or the like may be applied. The single protrusion may be expandable and may, for example, further comprise concentric or serial chambers.

Referring to fig. 26, as shown, a plurality of tentacles or protrusions 814 may be used to deliver material, such as bone cement, via one or more corresponding delivery lumens 816 connected with the balloon 800. In this way, different materials may be directed to different protrusions. A single tentacle or protrusion 814 may be associated with a single feeding cavity 816, multiple protrusions 814 may be associated with a single feeding cavity 816, and/or multiple protrusions 814 may be associated with multiple feeding cavities 816. The multiple supply chambers 816 can be connected to a single supply or multiple supplies and can be used simultaneously or non-simultaneously. In the alternative, the tentacle may be a sheath, lumen, or tube that completely or substantially covers the surface of the balloon 800, wherein, for example, the sheath may have holes that can be withdrawn and/or squeezed out when the sheath is pressed against the cortical bone.

The various schemes proposed in the present invention are various examples. Those skilled in the art will be able to make modifications and variations without departing from the spirit and scope of the disclosed void formation apparatus and method. The scope of the invention is, therefore, indicated by the appended claims and their legal equivalents, rather than by the examples given.

Claims (86)

1. An apparatus for orthopedic cavity formation, comprising:

(a) an insert member, wherein the insert member comprises an elongated body extending along a first axis;

(b) an end effector, wherein the end effector is coupled to the insertion member and disposed at a distal end of the insertion member;

(c) a first hinge region, wherein the end effector is configured to hinge relative to the insertion member at the first hinge region such that the end effector is offset from the first axis; and

(d) a cutting member, wherein the cutting member is configured to selectively expand from the end effector between a retracted position and an expanded position.

2. The apparatus of claim 1, wherein the first articulation region is a pivot pin about which the end effector articulates relative to the insertion member.

3. The apparatus of claim 1, wherein the end effector is configured to articulate relative to the insertion member into alignment with the second axis.

4. The apparatus of claim 3, wherein the cutting member is configured to expand outwardly when the end effector is articulated.

5. The apparatus of claim 1, wherein the end effector is configured to articulate relative to the insertion member by a mechanical articulation.

6. The apparatus of claim 1, wherein the end effector is configured to rotate relative to the insertion member such that when the cutting member is in the expanded position, rotating the end effector causes the cutting member to cut cancellous vertebral bone.

7. The apparatus of claim 1, wherein the hinged end effector is configured to rotate to form the void while the cutting member is expanded.

8. The apparatus of claim 1, wherein the end effector is configured to rotate and articulate simultaneously.

9. The apparatus of claim 1, further comprising a second articulation region, wherein the distal portion of the end effector is configured to articulate relative to the proximal end of the end effector.

10. A method of tissue cavity formation comprising the steps of:

providing a tissue cavity formation device, the tissue cavity formation device comprising:

(a) an insert member, wherein the insert member comprises an elongated body extending along a first axis;

(b) an end effector, wherein the end effector is coupled to the insertion member and disposed at a distal end of the insertion member;

(c) a first hinge region, wherein the end effector is configured to hinge relative to the insertion member at the first hinge region, wherein the hinge at the first hinge region causes the end effector to deflect from the first axis of the insertion member; and

(d) a cutting member coupled with the end effector, wherein the cutting member is configured to selectively expand from the end effector;

inserting the tissue cavity forming device into tissue, wherein the end effector and the insertion member are aligned with the first axis;

articulating the end effector relative to the insertion member at a first articulation zone such that the end effector is aligned with the second axis;

expanding the cutting member from the end effector; and

the end effector is rotated to form a tissue cavity.

11. The method of claim 10, wherein the step of articulating the end effector relative to the insertion member comprises mechanically articulating the end effector.

12. The method of claim 10, further comprising the step of forming an initial access channel in the tissue, wherein the cavity-forming device is inserted into the initial access channel.

13. The method of claim 10, wherein the step of inserting the cavity formation device into the tissue further comprises forming a first portion of the tissue cavity, wherein forming the first portion of the tissue cavity comprises expanding the cutting member from the end effector and rotating the end effector, wherein the end effector and the insertion member remain aligned with the first axis.

14. The method of claim 10, wherein the step of articulating the end effector relative to the insertion member further comprises articulating the end effector while rotating the end effector to form a portion of the tissue cavity.

15. The method of claim 10, wherein the tissue cavity is an orthopedic cavity.

16. The method of claim 15, wherein the orthopedic cavity is a spinal cavity.

17. The method of claim 16, wherein the spinal cavity is a vertebral cavity.

18. The method of claim 10, wherein the tissue cavity formation device is rotated about the first axis after articulating the end effector.

19. The method of claim 19, wherein the tissue cavity formation device is rotated about the first axis after articulating the end effector while rotating the end effector about the second axis.

20. The method of claim 10, wherein the step of articulating the end effector relative to the insertion member further comprises the steps of:

an articulated end effector first distance;

rotating the end effector to form a portion of the tissue cavity; and

the hinged end effector a second distance.

21. The method of claim 10, further comprising the steps of:

providing a fracture reduction device;

inserting a fracture reduction device into the tissue cavity;

expanding the fracture reduction device to reduce the fracture; and

bone cement is delivered into the tissue cavity.

22. The method of claim 10, wherein the step of articulating the end effector relative to the insertion member comprises articulating the end effector in a stepwise manner including partially expanding the cutting member a first distance from the end effector, rotating the end effector to form a first tissue cavity portion, articulating the end effector in the first tissue cavity portion, rotating the end effector to form a second tissue cavity portion, and articulating the end effector in the second tissue cavity portion, wherein the articulating of the end effector is performed in a stepwise manner until the end effector is aligned with the second axis.

23. The method of claim 10, wherein the cutting member is an elongated strip.

24. A method of tissue cavity formation comprising the steps of:

forming an access channel in tissue;

providing a tissue cavity forming device, wherein the tissue cavity forming device comprises:

(a) an insert member, wherein the insert member includes an elongated body extending along a first axis;

(b) an end effector, wherein the end effector is coupled to the insertion member and disposed at a distal end of the insertion member;

(c) a first articulation region, wherein the end effector is configured to articulate relative to the insertion member at the first articulation region; and

(d) a cutting member coupled with the end effector, wherein the cutting member is configured to selectively expand outward from the end effector;

inserting a tissue cavitation instrument into the tissue channel with the end effector and the insertion member aligned along a first axis and the cutting member in a retracted position;

laterally expanding the cutting member such that it extends outwardly from the end effector of the tissue cavity formation instrument;

rotating the end effector about a first axis to form a first tissue cavity portion of the tissue cavity;

further outwardly expanding the cutting member;

rotating the end effector about a first axis to enlarge the first tissue cavity portion;

articulating an end effector of a tissue cavity formation instrument such that the end effector is offset from a first axis and aligned with a second axis;

rotating the end effector about a second axis to form a second tissue cavity portion of the vertebral cavity;

articulating an end effector of the tissue cavity formation instrument such that the end effector is offset from the second axis and aligned with the third axis;

rotating the end effector about a third axis to form a third tissue cavity portion of the vertebral cavity.

25. The method of claim 24, further comprising the steps of:

providing a fracture reduction device;

inserting a fracture reduction device into the vertebral cavity;

expanding the fracture reduction device to reduce the fracture; and

bone cement is delivered into the vertebral cavity.

26. The method of claim 24, wherein the tissue cavity is an orthopedic cavity

27. The method of claim 26, wherein the orthopedic cavity is a spinal cavity.

28. The method of claim 27, wherein the spinal cavity is a vertebral cavity.

29. A cutting apparatus comprising:

(a) a handle;

(b) an insertion tube, wherein the insertion tube is coupled with the handle;

(c) an end effector, wherein the end effector is coupled to the insertion tube, wherein the end effector further comprises:

(i) a body having a proximal portion and a distal portion;

(ii) a bore formed in the body;

(iii) a cross member disposed within the bore of the body adjacent the distal end of the body;

(iv) a cutting member comprising an elongated portion having a first end and a second end, wherein the first end of the cutting member is coupled with the proximal portion of the end effector body and the elongated portion is wrapped around the transverse member; and

(d) an elongated shaft coupled to the second end of the cutting member, wherein the shaft is coupled to the cutting member such that distal translation of the shaft urges the cutting member outward through the aperture of the end effector and proximal translation of the shaft retracts the cutting member into the aperture and against the transverse member.

30. The apparatus of claim 29, wherein the cross member is selected from the group consisting of a pin, a latch, and a guide.

31. The apparatus of claim 29, wherein the shaft is directly coupled to the second end of the cutting member.

32. The apparatus of claim 29, wherein the cutting member is an elongated member selected from the group consisting of: flexible components, semi-rigid components, belts, polymer components, metal components, shape memory alloy components, nickel-titanium alloy components, aluminum components, carbon steel components, titanium components, stainless steel components, and combinations thereof.

33. The apparatus of claim 29, wherein the end effector further comprises a transition member, wherein the transition member connects the shaft with the second end of the cutting member.

34. The apparatus of claim 33, wherein the transition member is guided by a guide rail.

35. The apparatus of claim 33, wherein the transition member is guided by a keyway.

36. The apparatus of claim 33, wherein the transition member prevents rotation of the shaft relative to the end effector.

37. The apparatus of claim 29, wherein the cutting member is fully retracted within the aperture of the end effector when the cutting member is tightened against the cross member.

38. The apparatus of claim 29, wherein the end effector is configured to articulate and rotate.

39. The apparatus of claim 29, wherein the first end of the cutting member is crimped around the proximal end of the end effector.

40. The apparatus of claim 29, wherein the working length of the cutting member is substantially the length of the end effector.

41. A cutting apparatus comprising:

(a) a handle;

(b) an insertion tube, wherein the insertion tube is coupled with the handle;

(c) an end effector, wherein the end effector is coupled to the insertion tube, wherein the end effector comprises:

(i) a body having a proximal portion and a distal portion;

(ii) a bore formed in the body, the bore having a proximal end and a distal end;

(iii) a cross member disposed within the bore of the body adjacent the proximal end of the bore;

(iv) a cutting member comprising an elongated portion having a first end and a second end, wherein the first end of the cutting member is coupled with the distal end portion of the body of the end effector and the elongated portion is wrapped around the transverse member; and

(d) an elongated shaft coupled to the second end of the cutting member, wherein the shaft is coupled to the cutting member such that proximal translation of the shaft urges the cutting member outward through the aperture of the end effector, and distal translation of the shaft retracts the cutting member into the aperture and against the transverse member.

42. The apparatus of claim 41 wherein the cross member is selected from the group consisting of a pin, a latch, and a guide.

43. The apparatus of claim 41, wherein the shaft is directly coupled to the second end of the cutting member.

44. The apparatus of claim 41, wherein the cutting member is an elongated member selected from the group consisting of: flexible components, semi-rigid components, belts, polymer components, metal components, shape memory alloy components, nickel-titanium alloy components, aluminum components, carbon steel components, titanium components, stainless steel components, and combinations thereof.

45. The apparatus of claim 41, wherein the end effector further comprises a transition member, wherein the transition member connects the shaft with the second end of the cutting member.

46. The apparatus of claim 45, wherein the transition member is guided by a guide rail.

47. The apparatus of claim 45, wherein the transition member is guided by a keyway.

48. The apparatus of claim 45, wherein the transition member prevents rotation of the shaft relative to the end effector.

49. The apparatus of claim 41, wherein the cutting member is fully retracted within the aperture of the end effector when the cutting member is pulled taut against the cross member.

50. The apparatus of claim 41, wherein the end effector is configured to articulate and rotate.

51. An orthopedic fracture reduction apparatus comprising:

(a) an expandable member having an inner surface and an outer surface;

(b) an inflation lumen in fluid communication with the inflatable member, wherein the inflation lumen is configured for supplying a flowable material to inflate and deflate the inflatable member;

(c) a tentacle coupled to the inflatable member, wherein the tentacle includes at least one aperture; and

(d) a supply lumen in fluid communication with the tentacle, wherein the supply lumen is configured for supplying a flowable material into the tentacle and through the at least one aperture.

52. The apparatus of claim 51, wherein the at least one aperture comprises a plurality of apertures.

53. The apparatus of claim 51, wherein the tentacle is coupled to an outer surface of the inflatable member.

54. The apparatus of claim 51, wherein the tentacle is configured to deliver bone cement through the at least one hole into the vertebral cavity.

55. The apparatus of claim 51, wherein the tentacle and the feeding lumen comprise a continuous lumen.

56. The apparatus of claim 51, further comprising a plurality of tentacles, wherein each tentacle of the plurality of tentacles comprises at least one aperture.

57. The apparatus of claim 56, wherein the at least one aperture comprises a plurality of apertures.

58. The apparatus of claim 56, wherein a plurality of tentacles are associated with the inflation lumen, wherein the inflation lumen is configured to supply the flowable material to each of the plurality of tentacles.

59. The apparatus of claim 56, wherein each of the plurality of tentacles is associated with an outer surface of the inflatable member.

60. The apparatus of claim 56, wherein a plurality of tentacles are associated with a plurality of feeding lumens.

61. The apparatus of claim 60, wherein each of the plurality of tentacles is associated with one of the plurality of feeding lumens.

62. The apparatus of claim 51, wherein the tentacle passes through the inflatable member.

63. The apparatus of claim 51, wherein the feeding lumen is a rigid tube and the tentacle is a flexible member.

64. The apparatus of claim 51, wherein the feeding lumen and tentacle are continuous flexible lumens.

65. The apparatus of claim 51, wherein the tentacle is integral with an outer surface of the inflatable member.

66. The apparatus of claim 51, wherein at least one orifice is used to supply flowable material to a predetermined area.

67. The device of claim 66, wherein the predetermined region is a posterior side of a vertebral body.

68. The apparatus of claim 51, wherein the tentacle substantially covers the inflatable member.

69. An orthopedic fracture reduction apparatus comprising:

(a) an expandable member having an inner surface and an outer surface;

(b) an inflation lumen in fluid communication with the inflatable member, wherein the inflation lumen is configured for supplying a flowable material to inflate and deflate the inflatable member;

(c) a supply lumen, wherein the supply lumen of the flowable material passes through the expandable member, wherein the supply lumen of the flowable material is configured to supply the flowable material through the expandable member;

(d) a tentacle coupled to the inflatable member, wherein the tentacle includes at least one aperture; and

(e) a tentacle supply lumen in fluid communication with the tentacle, wherein the tentacle supply lumen is configured to supply a flowable material into the tentacle and through the at least one aperture.

70. The apparatus of claim 69, wherein the at least one aperture comprises a plurality of apertures.

71. The apparatus of claim 69, wherein the tentacle is coupled to an outer surface of the inflatable member.

72. The apparatus of claim 69, further comprising a plurality of tentacles, wherein each of the plurality of tentacles comprises at least one aperture.

73. A method of providing a therapeutic effect comprising the steps of:

there is provided a tissue manipulation device comprising:

(a) an expandable member having an inner surface and an outer surface;

(b) an inflation lumen in fluid communication with the inflatable member, wherein the inflation lumen is configured to supply a flowable material to inflate and deflate the inflatable member;

(c) a tentacle coupled to the inflatable member, wherein the tentacle includes at least one aperture; and

(d) a tentacle supply lumen in fluid communication with the tentacle, wherein the tentacle supply lumen is configured for supplying a flowable material into the tentacle and through the at least one aperture;

inserting the tissue manipulation device into tissue;

inflating the inflatable member through the inflation lumen; and

flowable material is supplied through the tentacles via the tentacle supply lumen.

74. The method of claim 73, further comprising the step of gradually deflating the inflatable member while the flowable material is being delivered by the tentacle.

75. The method of claim 73, wherein the fracture reduction device further comprises a first tentacle passing through the expandable member and a second tentacle coupled to an outer surface of the expandable member.

76. The method of claim 75, further comprising the step of simultaneously delivering flowable material through the first tentacle and the second tentacle.

77. The method of claim 75, further comprising the steps of:

gradually reducing the expandable member; and

the flowable material is supplied through the first tentacle when the expandable member is 27.

78. The method of claim 75, further comprising the steps of:

gradually reducing the expandable member; and

the flowable material is delivered through the second tentacle as the inflatable member is progressively deflated.

79. The method of claim 75, further comprising the step of delivering flowable material through the first tentacle and the second tentacle while the expandable member is expanding.

80. The method of claim 73, wherein the tentacle is associated with an outer surface of the inflatable member.

81. The method of claim 73, wherein the tentacle passes through the center of the inflatable member.

82. The method of claim 73, wherein the tissue is orthopedic tissue.

83. The method of claim 82, wherein the orthopedic tissue is spinal tissue.

84. The method of claim 83, wherein the spinal tissue is vertebral tissue.

85. The method of claim 84, wherein the expandable member is used to reduce a fracture in the vertebral tissue.

86. The method of claim 73, further comprising the step of delivering flowable material through the tentacle via the tentacle delivery lumen prior to inflating the inflatable member.