HK1178771B - Apparatus and methods for bone access and cavity preparation - Google Patents

Description

Devices and methods for bone access and cavity preparation

Cross Reference to Related Applications

This application is a non-provisional application of U.S. provisional application No.61/296,722 filed on 20/1/2010 and U.S. provisional application No.61/389,507 filed on 4/10/2010, both of which are incorporated herein by reference in their entirety.

Technical Field

Aspects of the present disclosure relate to providing devices and methods for repairing bone fractures. In particular, the present disclosure relates to devices and methods for repairing bone fractures using instruments inserted into the bone.

Background

Fracture fixation may involve the use of structures to counteract or partially counteract forces acting on the fractured bone or associated bone fractures. In general, fracture fixation may provide longitudinal (along the long axis of the bone), transverse (across the long axis of the bone), and rotational (about the long axis of the bone) stability. Fracture fixation can also maintain normal biological and healing functions.

Fracture fixation often involves addressing loading conditions, fracture patterns, alignment, compression forces, and other factors, which may vary for different types of fractures. For example, a mid-section fracture may have sufficient bone material on either side of the bone fragment into which the anchor may be driven. End fractures, particularly fractures on the articular surface, may have thin cortical bone, soft cancellous bone, and relatively few possible anchoring locations. Typical fracture fixation methods may involve one or both of the following: (1) devices within the skin (internal fixation); and (2) devices that extend out of the skin (external fixation).

Internal fixation methods typically involve one or both of the following: (a) a plate screwed onto the outside of the bone; and (b) an implant inserted into the inside of the bone.

Plates are often characterized by less invasive surgery, supporting the fractured bone segment from one side of the outside of the bone, and screws anchored into the plate and bone.

The implant may comprise an intramedullary rod or nail, such as those used in mid-stream treatments. A typical intramedullary rod or nail is fixed in diameter and introduced into the intramedullary canal through an incision. Flexible intramedullary rod-like solutions utilize structures that can be inserted through an access site into the intramedullary canal and subsequently become rigid. The flexible structure may be reinforced with a polymer or cement. A multi-segment fracture of a middle or end bone may require alignment and stability in a manner that generates sufficient fixation in multiple directions. The implants may be used to treat mid-section fractures and end fractures.

Implant-based treatments may involve removing bone tissue from within the bone to prepare the interior for an implant. Preparation for an implant may involve providing a space in the interior of the bone for receiving the implant.

Proper location, size, shape, orientation, and proximity to bone fractures and anatomical structures, among other things, can increase the therapeutic effectiveness of the implant.

Thus, it is desirable to provide devices and methods for preparing the interior of a bone.

Drawings

The objects and advantages of the present invention will be apparent upon consideration of the following detailed description, taken in conjunction with the accompanying drawings, in which like reference numerals refer to like parts throughout, and in which:

fig. 1 illustrates an exemplary apparatus according to the principles of the present invention.

Fig. 2 shows an exemplary anatomical structure in which the present invention may be practiced.

FIG. 3 shows a view of a portion of the apparatus shown in FIG. 1 taken along line 3-3 (shown in FIG. 1).

FIG. 4 shows a view of a portion of the apparatus shown in FIG. 1 taken along line 4-4 (shown in FIG. 1).

FIG. 5 shows a view of a portion of the apparatus shown in FIG. 1 taken along line 5-5 (shown in FIG. 1).

Fig. 6 shows a portion of the device shown in fig. 1 along with another device in accordance with the principles of the present invention.

Fig. 7 shows a part of the device shown in fig. 1 in a state different from the state shown in fig. 1.

Fig. 8 shows a part of the device shown in fig. 1.

Fig. 9 shows a portion of the device shown in fig. 1 along with another device in accordance with the principles of the present invention.

Fig. 10 shows a part of the device shown in fig. 1.

Fig. 11 illustrates another exemplary apparatus according to the principles of the present invention.

FIG. 12 illustrates a partial cross-sectional view of the device shown in FIG. 11, taken along line 12-12 (shown in FIG. 11).

FIG. 13 illustrates a partial cross-sectional view of the device shown in FIG. 11, taken along line 13-13 (shown in FIG. 11).

Fig. 14 illustrates another exemplary apparatus according to the principles of the present invention.

Fig. 15 shows a portion of the device shown in fig. 14.

Fig. 16 shows a portion of the apparatus shown in fig. 11 (labeled "16").

FIG. 17 shows a view of a portion of the apparatus shown in FIG. 16 taken along line 17-17 (shown in FIG. 16).

FIG. 18 shows a view of the device shown in FIG. 17 taken along line 18-18 (shown in FIG. 17).

Fig. 19 illustrates another exemplary apparatus according to the principles of the present invention.

FIG. 20 illustrates a partial cross-sectional view of the device shown in FIG. 7, taken along line 20-20 (shown in FIG. 7).

FIG. 21 shows a partial cross-sectional view of the device shown in FIG. 8, taken along line 21-21 (shown in FIG. 8).

FIG. 22 illustrates a partial cross-sectional view of the device shown in FIG. 21, taken along line 22-22 (shown in FIG. 21).

Fig. 22A shows the device shown in fig. 22 along with an exemplary anatomical structure in which the invention may be practiced.

FIG. 23 shows a view of the device shown in FIG. 20 taken along line 23-23 (shown in FIG. 20).

FIG. 24 illustrates a partial cross-sectional view of the device shown in FIG. 8, taken along line 24-24 (shown in FIG. 8).

Fig. 25 shows a portion of the device shown in fig. 9 along with another device.

FIG. 26 illustrates a partial cross-sectional view of the device shown in FIG. 25, taken along line 26-26 (shown in FIG. 25).

Fig. 27 shows information that may be used to fabricate a device according to the principles of the present invention.

FIG. 28 illustrates a partial cross-sectional view of the device shown in FIG. 25, taken along line 28-28 (shown in FIG. 21).

FIG. 29 shows a partial cross-sectional view of the device shown in FIG. 25, taken along line 29-29 (shown in FIG. 25).

Fig. 30 shows the device shown in fig. 25 in a state different from that shown in fig. 25.

Fig. 31 shows yet another apparatus in accordance with the principles of the present invention.

Fig. 32 illustrates yet another apparatus in accordance with the principles of the present invention.

Fig. 33 shows yet another apparatus in accordance with the principles of the present invention.

Fig. 34 illustrates yet another apparatus in accordance with the principles of the present invention.

Fig. 35 shows yet another apparatus in accordance with the principles of the present invention.

Fig. 36 shows yet another apparatus according to the principles of the present invention.

Fig. 37 shows a portion of the device shown in fig. 36.

FIG. 38 shows a partial cross-sectional view of the device shown in FIG. 37, taken along line 38-38 (shown in FIG. 37).

FIG. 39 illustrates a partial cross-sectional view of the device shown in FIG. 37, taken along line 39-39 (shown in FIG. 37).

FIG. 40 shows a partial cross-sectional view of the device shown in FIG. 37, taken along line 40-40 (shown in FIG. 37).

Fig. 41 illustrates yet another apparatus according to the principles of the present invention.

Fig. 42 illustrates yet another apparatus in accordance with the principles of the present invention.

Detailed Description

Devices and methods for preparing an interior of a bone for treatment are provided. The treatment may comprise treatment for bone fractures. The devices and methods may involve orienting a surgical instrument for proper deployment within the bone. The surgical instrument may provide access to the bone interior from outside the bone. The surgical instrument may prime the interior to receive a therapeutic instrument. The surgical instrument may comprise a therapeutic instrument.

Devices and methods for positioning a surgical instrument relative to an external structure of a bone are provided. The device may be a surgical instrument guide.

The surgical instrument may be an instrument for repairing the bone. The surgical instrument may be a prosthetic device. For example, the surgical instrument may include one or more features of the instrument shown and described in U.S. patent application publication No.2009/0182336a1, the entire contents of which are incorporated herein by reference. The surgical instrument may be used to access an interior region of the bone. For example, the surgical instrument may be a bone saw. The surgical instrument may be a drill. The surgical instrument may be used to prepare the interior region of the bone to receive a therapeutic device. For example, the surgical instrument may be a broach (broach).

The surgical instrument may have a portion configured to be positioned in a target region within a bone.

The bone may have a surface. The surface may have a normal axis. The normal axis may be substantially perpendicular to the surface. The surface may have an anterior-posterior axis. The anterior-posterior axis may extend in a direction substantially perpendicular to the anterior and posterior sides of the bone. The surface may have a proximal-distal axis. The proximal-distal axis may extend substantially along the direction of the bone. The bone surface may have a curved portion. The curved portion may define a curved portion axis. The curved portion may be circumferential around the bone. The curved portion axis may be parallel or nearly parallel to the proximal-distal axis.

The surgical instrument guide may include bottom markings. The bottom mark may be provided for aligning the instrument at a position along the surface normal axis. The location may be flush with the surface. The bottom mark may be a bottom surface of the instrument. The bottom mark may be one or more structures extending from the bottom surface of the instrument.

The surgical instrument guide may include a first lateral extension and a second lateral extension. The first lateral extension may be configured to correspond to an anterior profile of the bone. The anterior profile may be a profile on an anterior side of the bone. The second lateral extension may be configured to correspond to a posterior contour of the bone. The posterior contour may be a contour on a posterior side of the bone. The first and second lateral extensions may be configured to align the instrument along the anterior-posterior axis.

The surgical instrument guide may include a distal marker. The distal marker may be configured to provide visual alignment along the proximal-distal axis.

In some embodiments, the surgical instrument guide may include a first bone contact. The first bone contact may be configured to engage the surface. The device may include a second bone contact. The second bone contact may be configured to engage the surface. The first and second bone contacts resist rotation about the surface normal axis when the first and second bone contacts engage the surface.

In some embodiments, the first and second bone contacts may be configured to penetrate the surface.

In some embodiments, the surgical instrument guide may include first and second lateral splints. The first transverse splint may be configured to engage an anterior portion of the bone. The second transverse splint may be configured to engage a posterior portion of the bone. The first and second lateral splints may resist rotation about the proximal-distal axis of the bone when the first and second lateral splints are engaged in the bone.

The surgical instrument guide may include an instrument guide member. The surgical instrument guide may include an alignment member. The alignment member may be configured to align the guide member with the bone. The surgical instrument guide may include a base member. The base member may support the alignment member.

In some embodiments, the surgical instrument guide may comprise a lateral splint. The lateral splint may be configured to resist movement of the base member in a direction along a circumference of the elongated bone. The lateral clamp plate may include a stem secured directly to the base.

In some embodiments, the surgical instrument guide may include a bone contact. The bone contact may be configured to resist rotation of the base about an axis substantially perpendicular to the surface.

In some embodiments, the bone contact may be a first bone contact and the surgical instrument guide may include a second bone contact. The first and second bone contacts may extend from a surface of the base. The first and second bone contacts may be configured to contact the bone surface along the curved portion axis of the bone surface.

In some embodiments, the surgical instrument may include a handle support and a grip. The handle may rotate relative to the handle support when a torque greater than a threshold torque is applied to the handle.

In some embodiments, the surgical instrument guide may comprise an alignment guide. The alignment guide may be configured to align the instrument guide member with a target area located on an inner side of the bone.

In some embodiments, the implement guide may be of a size that: the size corresponds to a size of a surgical instrument configured to be deployed through the surgical instrument guide member into the bone interior.

In some embodiments, the guide plate may comprise a fluorescently detectable material.

In some embodiments, the guide plate may be fixed to the base. The guide plate may be mapped to a transverse viewing plane located in the bone cavity.

In some embodiments, the guide plate may be mapped onto an anterior-posterior viewing plane located in the bone cavity.

In some embodiments, the surgical instrument guide may include a first guide plate mapped onto the transverse viewing plane and a second guide plate mapped onto the anterior-posterior viewing plane.

In some embodiments, the surgical instrument guide may comprise a channel. The channel may be configured to guide an elongate fixation member into the bone. The elongate securing member may be a wire. The wire may be a k-wire. The elongate securing member may be a rod. The rod may be a threaded rod.

In some embodiments, the surgical instrument guide may include a first channel and a second channel. The first and second channels may be configured to guide the first and second elongate fixation members into the bone.

In some embodiments, the first and second channels may be inclined to each other.

The method may include a method for performing a procedure in a bone interior. The method may include positioning an instrument guide located outside of the interior of the bone at a location corresponding to a target area located inside of the bone. The method may include generating an electronic image showing the instrument guide and the target area. The method may include delivering the instrument to the target area.

In some embodiments, the delivering may include arranging a guide member to guide the implement to the target area. The guide member may have a fixed orientation relative to the implement guide.

In some embodiments, the positioning may include positioning a coring saw profile.

In some embodiments, the positioning may include positioning a broach profile.

In some embodiments, the positioning may include positioning a prosthetic contour.

In some embodiments, the positioning may include positioning a bone implant profile.

In some embodiments, the generating may include receiving the image using fluoroscopy.

In some embodiments, the instrument guide may be a first instrument guide and the method may include positioning a second instrument guide located outside of the interior of the bone at a location corresponding to the target region; and generating an electronic image showing the second appliance guide plate and the target area.

In some embodiments, the positioning of the second fixture guide may comprise arranging the second fixture guide in a plane inclined with respect to a plane comprising the first fixture guide.

In some embodiments, the positioning of the second implement guide comprises arranging the second implement guide in a plane substantially perpendicular to a plane comprising the first implement guide.

In some embodiments, the conveying may include conveying a coring saw.

In some embodiments, the delivering may include delivering an intraosseous broach.

In some embodiments, the delivering may comprise delivering a prosthesis.

The method may include a method for guiding an instrument into an interior of a bone. The method may include positioning a tool guide adjacent to the bone. The instrument guide may include a first fixation element and a second fixation element.

The method may include passing a first fixation member through the bone such that the first fixation member is in contact with the first fixation element. The method may include passing a second fixation member through the bone such that the second fixation member is in contact with the second fixation element.

In some embodiments, the passing of the second fixation member may include orienting the second fixation member substantially obliquely with respect to the first fixation member.

In some embodiments, the passing of the second fixation member may include surrounding human tissue in an area defined by the first fixation member, the second fixation member, and the instrument guide such that the instrument guide is held adjacent to the bone by the human tissue.

Devices and methods for guiding an instrument relative to an elongated bone are provided. The device may be a surgical instrument guide.

The bone may have a longitudinal axis.

The surgical instrument guide may include an instrument guide member and a base member. The base member may support the guide member. The implement guide member may be configured to pivot relative to the base member from a first position to a second position. The first position may define a first angle relative to the longitudinal axis of the bone. The second position may define a second angle relative to the longitudinal axis of the bone.

In some embodiments, the surgical instrument guide may comprise an alignment guide. The alignment guide may align the instrument guide member with a first target area located on an inner side of the bone when the guide member is in the first position. The alignment guide may align the instrument guide member with a second target area located on an inner side of the bone when the guide member is in the second position.

In some embodiments, the guide plate may have a size corresponding to a size of a surgical instrument configured to be deployed through the instrument guide member into the bone interior.

In some embodiments, the guide plate may comprise a fluorescently detectable material.

In some embodiments, the guide plate may be fixed to the guide member. The guide plate may be mapped onto a transverse plane located in the interior of the bone. The guide plate may be mapped onto an anterior plane located in the bone cavity. The guide plate may be mapped onto a posterior plane located in the bone cavity.

In some embodiments, the guide may be a first guide and the surgical instrument guide may include a second guide. The second guide plate may be fixed to the guide member. The second guide plate may be mapped onto a transverse plane located in the bone cavity.

In some embodiments, the surgical instrument guide may include a guide member stop. The guide member stop may be configured to fix a position of the guide member relative to the base member.

In some embodiments, the stop may induce a frictional force between a first surface on the guide member and a second surface on the base member.

In some embodiments, the stop may comprise a protrusion that interferes with relative movement between the guide member and the base.

The method may include a method for introducing an instrument into an interior of a bone. The method may comprise introducing the appliance into a guide member pivotally mounted on a base. The base may be positioned adjacent to a bone. The method may include pivoting the guide member relative to the base to change an angle between the guide member and the base. The method may include advancing the instrument through the guide member.

In some embodiments, the pivoting may include adjusting the angle to align an instrument guide with a target area located inside the bone interior.

In some embodiments, the adjusting may include observing an electronic image showing the instrument guide and the target area.

In some embodiments, the method may include fixing an angle between the guide member and the base.

Devices and methods for broaching an interior region of a (broach) bone are provided. The bone may comprise a first bone material. The first bone material may comprise cancellous bone. The bone may comprise a second bone material. The second bone material may include cortical bone. The second bone material may have a density higher than a density of the first bone material.

The apparatus may comprise a rotator. The apparatus may include a broaching member.

The broaching member may be moved within the bone interior to displace, distract, disrupt, dislocate, gouge, grind, cut or broach bone material. The broaching member may be rotated within the bone interior. The rotation may be continuous. The rotation may be pulsed. The rotation may be unidirectional. The rotation may alternate between a first rotational direction and a second rotational direction.

The broaching member may be secured to the spinner. The broaching member may be configured to move relative to the rotator to displace bone material radially away from the rotator.

In some embodiments, the broaching member may be configured to substantially deflect about the second bone material.

In some embodiments, the broaching member may be configured to form a space in the bone having a first profile corresponding to the shape of the broaching member. The broaching member may be configured to form a space in the bone having a second contour corresponding to an anatomical structure including the second bone material. The broaching member may be a first broaching member and the device may include a second broaching member. The second broaching member may be positioned opposite the first broaching member.

In some embodiments, the broaching member may include a cutting edge.

In some embodiments, the broaching member may include a flexible wire segment. The wire section may comprise braided wires.

In some embodiments, the apparatus may include a reinforcement portion supporting the broaching member. The reinforcement may support a cutting edge.

In some embodiments, the broaching member may have a proximal portion secured to the spinner and a distal portion secured to the spinner.

In some embodiments, the broaching member may have a proximal end fixed to the rotator and a free distal end.

In some embodiments, the broaching member may include edges of open cells in a web.

The broaching member may include a segment having any suitable form. For example, the segments may be linear, circular, diamond-shaped, square, triangular, oval, elliptical, helical, doughnut, hoop, teardrop, whisk, football, or any other suitable shape. The sections may be closed loops. The loop may be asymmetric.

The segments may have one or more of a variety of transverse cross-sections, for example: square, rectangular, octagonal, a profile with sharp edges, a strand cable, or other suitable configuration to promote bone displacement.

The section may have a leading edge. The leading edge may be inclined at a suitable angle, including an angle of from about 5 ° to about 75 °. The angle may result in the leading edge 2202 being entirely sharp or knife-like.

The sections may be rigid. The segments may be resilient.

The broaching member may have one or more ends that attach to a device (e.g., a drive shaft) or a suitable support (e.g., a hub). The broaching member may have a free end. The broaching member with free distal end may have any suitable shape at the distal end of the tines, such as pointed, bifurcated, rounded, blunt or truncated.

The broaching member may have an end that is attached to the device by crimping, welding, set screws, snap-fitting, or any other suitable fastener. The broaching member may have one or more ends that are integrally constructed with the device.

The broaching member may include tines. The tines may be resilient or stiff. The tines may have ends that attach to a drive shaft. The tines may have free ends.

The broaching member may include a blade.

The broaching member may include a plurality of interconnected cells. The units may be arranged as a network. The cells may be connected such that when the structure is stressed (e.g., compressed) at one point, the stress is distributed to nearby cells. The unit may be constructed of laser cut tubing expanded to the appropriate shape.

The broaching member may be one of a plurality of broaching members located in a broaching head. For example, the broaching head may have one broaching member, 2-6 broaching members, 7-20 broaching members, more than 20 broaching members, 100 broaching members, or any suitable number of broaching members.

When there are multiple broaching members during rotation of the broaching head (i.e., when the circumferential density of the broaching members is high), a lower torque may be required to drive the broaching head.

The broaching member may be rotated in a bone cavity having an irregular shape (e.g., non-circular, oblong, or angled). The bone cavity may be smaller than a diameter of the broaching member.

The broaching member may include any suitable configuration such as, for example, a wire, a ribbon, a cable, a strand, a braid, or any other suitable configuration.

The broaching member may comprise any suitable material, such as a polymer, metal, composite material, stainless steel, nitinol (shaped, superelastic, or other nitinol), other alloys, or any other suitable material.

The broaching member may be supported by one or more enhancements.

The reinforcement portion may be sized and positioned to support a section of the broaching member having a desired profile. The reinforcement may provide bone broach abrasiveness, momentum, or both.

The reinforcement may be a tube.

The reinforcement may be a stent. The holder may be fixed to the broaching member, for example, by crimping, welding or press-fitting. The bracket may include a broaching edge for displacing bone material. The broaching edge may have any suitable form, such as serrated, knife-edge, straight edge, or any other suitable form.

The reinforcement may be formed from a polymer, metal, alloy, or any other suitable material.

The reinforcement may be formed of a pattern cut into the metal tube.

In some embodiments, the apparatus may include a remote interface. The broaching member may have a distal portion secured to the distal hub. The distal interface may be configured to move between a first position and a second position. The first and second positions may be set along a longitudinal axis of the rotator.

The distal interface may be constructed of metal, stainless steel, laser cut tubing, polymer, ceramic, or any other suitable material.

The distal interface may include a recess. The distal interface may include a broaching edge.

The method may include a method for broaching an interior region of a bone. The inner region may include a bottom surface. The bottom surface may be a surface of a portion of the bone opposite an access hole in the bone.

The method may include expanding a bone broaching member in the interior region. The method may include using the member to separate relatively less dense material inside the bone. The method may include deflecting the broaching member away from the relatively higher density material inside the bone.

In some embodiments, the method may include rotating the bone broaching member using a flexible drive shaft.

In some embodiments, the method may include varying a height of the bone broaching member relative to the bottom surface.

In some embodiments, the separating may include cutting the relatively lower density material.

In some embodiments, the separating may include displacing the relatively lower density material.

In some embodiments, the method may include aligning an external instrument guide with the bone broach member; visually mapping the external instrument onto the internal region; and deploying the bone broach member onto the inner region based on the external instrument guide. The external instrument guide may be external to the bone.

Devices and methods for treating an interior of a bone are provided.

The apparatus may comprise a flexible sheath. The flexible sheath may include a stress-relaxing structure that allows bending under tension and compression. The stress relaxation structures may comprise slots or a pattern of slots. The stress relaxation structures may be positioned using laser cutting.

The stress relaxation structure may comprise sintered particles. The particles may comprise metal, polymer, composite material or any other suitable material.

The flexible sheath may have a first configuration and a second configuration. The second configuration may have a smaller radius of curvature than the first configuration. The device may comprise a rotatable shaft. The rotatable shaft may extend through the sheath. The device may include an elongated steering member. The elongate steering member may be configured to deflect the flexible sheath from the first configuration to the second configuration.

In some embodiments, the elongate steering member may be configured to elastically deform when the elongate steering member deflects the flexible sheath from the first configuration to the second configuration.

In some embodiments, the elongate steering member may include a first portion. The first portion may be translatable along a longitudinal direction of the sheath. The elongated steering member may include a second portion. The second portion may be configured to extend radially outward through a channel in the sheath when the elongated steering member deflects the flexible sheath from the first configuration to the second configuration.

In some embodiments, the rotatable shaft may have a distal end and the device may include an expandable head extending from the distal end. The expandable head may include a compressed configuration for translation within the sheath. The expandable head may comprise an expanded configuration when the expandable head is deployed outside of the sheath.

In some embodiments, the expandable head may be configured to displace cancellous bone rather than cortical bone.

Devices and methods for preparation of the interior of a bone are provided.

The device may comprise an elongate member. The elongate member may have a longitudinal axis. The elongate member may be curved about the longitudinal axis. The elongate member may be configured to rotate about the longitudinal axis inside the bone.

In some embodiments, the elongate member may comprise a generally helical section. The helical section may include a proximal end and a distal end. The proximal end portion may be positioned at a first radius of the longitudinal axis. The distal portion may be positioned at a second radius of the longitudinal axis. The second radius may be at least as large as the first radius. The second radius may be greater than the first radius.

In some embodiments, the elongate member may be a first elongate member and the device may comprise a second elongate member. The second elongated member may be curved about the longitudinal axis. The second elongate member may be configured to rotate about the longitudinal axis.

In some embodiments, the second elongate member may include a generally helical second section.

In some embodiments, the proximal portion may be a first proximal portion and the distal portion may be a first distal portion. The helical second section may include a second proximal end and a second distal end. The second proximal end portion may be positioned at a third radius of the longitudinal axis. The second distal end may be positioned at a fourth radius of the longitudinal axis. The fourth radius may be at least as large as the third radius. The fourth radius may be greater than the third radius.

In some embodiments, the third radius may be substantially the same as the first radius; and the fourth radius may be substantially the same as the second radius.

In some embodiments, the device may include a circumferential offset. The circumferential offset may be in a circumferential direction about the longitudinal axis. The circumferential offset may be between the second proximal end portion and the first proximal end portion. The circumferential offset may be between the second distal end and the first distal end.

In some embodiments, the device may comprise a support. The support member may include a proximal support end. The proximal bearing end may be fixed to the shaft. The device may comprise a support section. The support segment may be secured to at least one of the first and second helical segments. The support segment may conform to the contour of the helical segment.

The method may include a method for preparing an interior of a bone. The method may include positioning an access port into the intramedullary space of the bone. The method can include introducing an elongate member into the intramedullary space. The elongate member may have a generally helical section. The helical section may have a longitudinal axis. The method may include rotating the generally helical section about the longitudinal axis to displace cancellous bone material.

In some embodiments, the elongate member may be a first elongate member, the generally helical section may be a first generally helical section, and the method may include introducing a second elongate member into the intramedullary space. The second elongate member may have a generally helical second section. The generally helical second section may share the longitudinal axis with the first generally helical section. The method may include rotating the generally helical second section about the longitudinal axis.

In some embodiments, the first helical section may have a first periodic period of rotation. The second helical section may have a second periodic period of rotation. The second periodic rotation period may lag the first periodic rotation period by a phase lag. The phase lag may be about Pi radians.

Devices and methods for sawing holes in bone are provided. The bone may have a longitudinal bone axis.

The device may comprise a bone coring saw. The bone coring saw may include teeth. The teeth may include a first cutting member and a second cutting member. The first cutting member may be configured to cut bone when the coring saw is rotated in a first direction. The second cutting member may be configured to cut bone when the coring saw is rotated in a second direction. The second direction may be opposite to the first direction.

The bone coring saw may comprise a cylindrical tube. The cylindrical tube may define a tube longitudinal direction and a tube radial direction. The bone coring saw may include serrations. The serrations may extend longitudinally from an end of the cylindrical tube. The serrations may include a cutting surface inclined with respect to a radial direction of the tube.

The method may include a method for sawing a hole in the bone. The method may include forming a generally cylindrical passage into the intramedullary space of the bone. The generally cylindrical passage may extend in a direction at an acute angle to the longitudinal bone axis. The method may include removing a generally cylindrical plug from the bone substantially coaxial with the passage.

In some embodiments, the forming may include forming a tunnel through the bone using a k-wire.

In some embodiments, the removing may include sawing the hole using a rotary coring saw.

In some embodiments, the method may include rotating the rotary coring saw about a portion of the k-wire.

In some embodiments, the method may include maintaining a coaxial relationship between the k-wire and the rotary coring saw. The maintaining may include rotating the rotary coring saw about a sleeve. The k-wire, the sleeve, and the rotary coring saw may be substantially coaxial.

In some embodiments, the method may include translating the k-wire relative to the rotary coring saw to remove the cylindrical plug from the coring saw.

The method may include a method for locating an access port within an intramedullary space with respect to a bone. The method may include supporting a cylindrical body of a rotary saw at an acute angle to a surface of the bone; and engaging teeth of the rotary saw with the surface.

Devices and methods for accessing the medial side of a bone are provided.

The apparatus may include a rotatable saw including a sleeve. The device may include a sleeve positioned in the cannula. The device may comprise a wire positioned in the sleeve substantially coaxially with the rotatable saw.

In some embodiments, the wire may include a distal portion configured to penetrate the bone. The wire may include a proximal end configured to receive torque.

In some embodiments, the wire may be configured to drill a pilot hole in the bone. The guide hole may have an axis forming an acute angle with the surface of the bone at an opening of the guide hole. The saw may include teeth. The teeth may be disposed adjacent the distal end of the cannula. The sleeve may be configured to coaxially align the rotatable saw with the axis when the teeth are in contact with the bone.

In some embodiments, the device may include a biasing member proximate the sleeve. The biasing member may be biased to urge the distal end of the sleeve toward the bone when the teeth have penetrated into the bone.

In some embodiments, the sleeve may fit within the sleeve with a tolerance that provides friction between the sleeve and the rotatable saw. The friction may resist a proximally directed force from a bone core in the cannula as the teeth are cut into the bone.

In some embodiments, the rotatable saw may include a cylindrical body having a wall thickness traversed by a vent. The discharge port may be configured to discharge bone material.

In some embodiments, the wire may include a distal diameter and a proximal diameter. The proximal diameter may be greater than the distal diameter. The wire may include a shoulder where the distal diameter abuts the proximal diameter. The shoulder may be configured to translate proximally relative to the rotatable saw to eject a bone core from the cannula.

The device may include an assembly for accessing the medial side of the bone.

The assembly may include arranged teeth. The teeth may be supported at the ends of the rotatable frame. The frame may define one or more passageways. The passageway may extend from a sleeve located inside the frame to a region located outside the frame.

In some embodiments, the assembly may comprise a sleeve. The sleeve may be positioned in the cannula. The assembly may comprise a wire. The wire may be positioned in the sleeve substantially coaxially with the rotatable saw.

In some embodiments, the wire may be configured to drill a pilot hole in the bone. The guide hole may have an axis forming an acute angle with the surface of the bone at an opening of the guide hole. The sleeve may be configured to coaxially align the rotatable saw with the axis when the teeth are in contact with the bone.

Devices and methods for preparing an interior of a bone are provided. The device may have a longitudinal device axis.

The apparatus may include one or more broaching members. The broaching member may be a blade. The first blade may be connected to the second blade by a linkage. The linkage may be configured to rotate about the longitudinal axis. The linkage may be configured to be radially displaced from the longitudinal device axis.

In some embodiments, at least one of the first and second blades may be rigid.

In some embodiments, at least one of the first and second blades may comprise stainless steel.

In some embodiments, at least one of the first and second blades may comprise nitinol.

In some embodiments, the linkage may include a pin.

In some embodiments, the linkage may be a first linkage. The device may comprise an actuator. The actuator is connected to the first blade by a second linkage. The actuator may be connected to the second blade by a third linkage. The actuator may include a body. The body may include members configured to be displaced relative to each other. One of the members may be fixed relative to the body.

In some embodiments, at least one of the second and third linkages may comprise a pin.

In some embodiments, the third linkage is distal from the second linkage.

In some embodiments, the actuator may be configured to radially displace the first linkage by varying a distance between the second linkage and the third linkage.

In some embodiments, the actuator may comprise a first elongate actuator member. The first elongated actuator member may be connected to the second linkage member. The actuator may comprise a second elongate actuator member. The second elongated actuator member may be connected to the third linkage. The second elongate actuator member may be configured to longitudinally displace the first linkage by changing a longitudinal offset between the first and second elongate members.

In some embodiments, the device may be configured to traverse a pathway located in the interior of the bone. The device may include a fourth linkage that limits the longitudinal offset based on a position of the device along the path.

In some embodiments, the fourth linkage may be a manual linkage.

In some embodiments, the longitudinal offset may comprise a range of values. The range of values may include a first value. The first value may correspond to a first radial displacement of the first linkage member. The range of values may include a second value. The second value may correspond to a second radial displacement of the first linkage member. The second radial displacement may be greater than the first radial displacement.

In some embodiments, the range may include a third value. The third value may correspond to a third radial displacement of the first linkage member. The third radial displacement of the first linkage piece may be less than the second radial displacement.

In some embodiments, the device may include a cutting surface. The cutting surface may be positioned on one of the first and second inserts. At the first and third radial displacements, the cutting surface may be disengaged from the bone.

In some embodiments, at the second radial displacement, the cutting surface may engage the bone.

In some embodiments, the first blade may have a first engagement portion. The first coupling portion may be interposed between the first and second linkage members. The first blade may have a first free portion. The first free portion may extend beyond the first linkage member in a direction away from the second linkage member.

In some embodiments, the second blade may have a second coupling portion. The second coupling portion may be interposed between the first and third linkages. The second blade may have a second free portion. The second free portion may extend beyond the first linkage in a direction away from the third linkage.

In some embodiments, the first binding portion may be longer than the second binding portion.

In some embodiments, the second bonding portion may be longer than the first bonding portion.

In some embodiments, the first free portion may be longer than the second free portion.

In some embodiments, the second free portion may be longer than the first free portion.

In some embodiments, the device may include a cutting surface. The cutting surface may be positioned on at least one of the first and second inserts. The fourth linkage may be designed to position the cutting surface at different radial displacements along the path. Each of the radial displacements may correspond to a longitudinal position on the path.

In some embodiments, the fourth linkage may control the longitudinal offset based on an electronic signal. The electronic signal may be based on a set of digital instructions. The digital instructions may be based on a digitized image of the interior of the bone.

In some embodiments, the device may include a third blade. The device may include a fourth blade. The third blade may be connected to the fourth blade by a fourth linkage. The fourth linkage may be configured to rotate about the longitudinal axis. The fourth linkage may be configured to be radially displaced from the longitudinal axis. The actuator may be configured to radially displace the fourth linkage by varying a longitudinal offset between the first and second elongate members.

The method may include a method for preparing the interior of the bone. The method may include rotating the cutting surface about an axis of rotation inside the bone. The method may include moving the control member from the first control position to the second control position.

The cutting surface may be configured to occupy a first radial position corresponding to the first control position. The cutting surface may be configured to occupy a second radial position corresponding to the second control position. The cutting surface may be configured to occupy a third radial position corresponding to the intermediate control position. The intermediate control position may be intermediate the first and second control positions. The third radial position may be located at a greater radial distance from the longitudinal axis than the first and second radial positions.

In some embodiments, the first and second radial positions may be located at substantially the same distance from the longitudinal axis.

In some embodiments, the cutting surface may be disengaged from the bone when the cutting surface is at one or both of the first and second radial positions. The cutting surface may engage the bone when the cutting surface is at the third radial position.

Devices and methods for locating bone fractures are provided.

The apparatus may include a probe support. The probe support may have a proximal end and a distal end. The device may include a handle. The handle may be attached to the proximal end portion. The apparatus may comprise a probe. The probe may be attached to the distal end portion. The probe bearing may be configured to pass through a sloped access hole in a metaphyseal bone surface. The probe support may be configured to provide mechanical communication between the handle and the probe when the handle is located outside of a bone interior and the probe is located inside of the bone interior.

In some embodiments, the probe may have a tapered tip.

In some embodiments, the probe may have a rounded tip.

In some embodiments, the probe support may include a proximal section and a distal section. The proximal section may extend from the handle. The distal section may support the probe.

In some embodiments, the proximal section and the distal section may define an obtuse angle.

In some embodiments, the proximal section may have a first flexibility. The distal section may have a second flexibility. The second flexibility may be greater than the first flexibility.

In some embodiments, the device may include an intermediate section. The intermediate section may be interposed between the proximal section and the distal section. The intermediate section may comprise a curved portion.

In some embodiments, the proximal section may have a first flexibility. The intermediate section may have a second flexibility. The distal section may have a third flexibility. The second flexibility may be greater than the third flexibility.

The method may include a method for treating bone. The bone may have a longitudinal bone axis.

The method may include positioning a hole in the bone. The hole may be angled with respect to the longitudinal bone axis. The hole may provide access to an interior region of the bone. The method may include advancing a probe through the bore and into the interior region. The method may include displacing cancellous bone using the probe.

In some embodiments, the displacing may include identifying a spatial distribution of the low-density species in the interior region.

In some embodiments, the method may include displaying an image of the inner region and the probe when the probe is inside the inner region.

The method may include another method for treating bone. The method may include providing a hole in the bone. The hole may be angled with respect to the longitudinal bone axis. The hole may provide access to an interior region of the bone. The method may include advancing a probe through the bore and into the interior region. The method may include displacing bone material using the probe.

In some embodiments, the displacing may include identifying a spatial distribution of cancellous bone in the interior region.

In some embodiments, the method may include displaying an image of the inner region and the probe when the probe is inside the inner region.

In some embodiments, the displacing may include positioning the first cortical bone crack relative to the second cortical bone crack.

In some embodiments, the method may include displaying an image of the inner region and the probe when the probe is inside the inner region.

The apparatus and method according to the present invention will be described with reference to the accompanying drawings. The figures illustrate features and methods of an apparatus according to principles of the present invention. The features will be described in the context of selected embodiments. It should be understood that features shown in connection with one of the embodiments may be implemented in accordance with the principles of the invention in combination with features shown in connection with another of the embodiments.

The devices and methods described herein are exemplary. The apparatus and methods of the present disclosure may involve some or all of the structure of an exemplary apparatus and/or some or all of the steps of an exemplary method. The steps of the methods may be performed in an order other than that shown or described herein. Some embodiments may omit steps shown or described in connection with the exemplary method. Some embodiments may include steps not shown or described in connection with the exemplary methods.

Exemplary embodiments will now be described with reference to the accompanying drawings, which form a part hereof.

The devices and methods of the present invention will be described in connection with exemplary bone repair devices and associated hardware and instruments. The apparatus and associated hardware and appliances will now be described with reference to the accompanying drawings. It is to be understood that other embodiments may be utilized and structural, functional, and procedural changes may be made without departing from the scope and spirit of the present invention.

Fig. 1 shows an exemplary instrument guide 100 positioned at site H' on bone B. Broach head 124 may be delivered to target region R of intramedullary space IS through guide 100_t. Target region R_tShown in cancellous bone B_CAWithin, but may be located in cancellous bone B_CAAnd cortical bone B_COEither or both. The side guides 130 and the top guide 132 are aligned with the guide tube 120. The arm 131 may support the guide plate 130. The practitioner may position guide plates 130 and 132 such that guide plates 130 and 132 "extend" to target region R_tSo that the guide 100 guides the bit 124 to the target region R_t。

Guide plate 130 may include lobed profile 134 and shaft profile 136 for achieving the "swept" area of broach head 124 and the positioning of shaft-like structure 125, respectively. Guide plate 132 may include lobed profile 138 and shaft profile 140 for achieving a targeted "swept" area of broach head 124 and positioning of shaft-like structure 125, respectively. Guides 130 and 132 may be configured to achieve the shape of any suitable implement that may be deployed, such as a drill, coring saw, prosthetic device, or any other suitable implement.

Fluorescence imaging may be used to align the guide plates 130 and 132 relative to the target region R_tAnd (6) positioning.

Broach head 124 may be rotated within intramedullary space IS to clear intramedullary bone material so that the prosthetic device may be implanted. Broach head 124 may be driven and supported by broach control portion 126 and broach sheath 127.

The guide 100 may include a base 102. Alignment members 104 and 106 (shown in FIG. 10) may extend from base 102 such that guide centerline CL of guide 100_GBone center line CL from the top surface of bone B_BSAnd (6) aligning. One or both of alignment members 104 and 106 may be resilient. One or both of alignment members 104 and 106 may be rigid.

Alignment members 104 and 106 may be relatively free to slide along the surface of bone B. The guide 100 can include a center line CL along which_BSAnd contact portions 108 and 110 (shown in fig. 10) that engage bone B. The contacts 108 and 110 may extend from a bottom surface (shown in fig. 10) of the guide 100. The contacts 108 and 110 may preventGuide center line CL_GFrom the center line CL of the bone_BSUnscrewing.

The contact portions 108 and 110 may ensure alignment of the guide 100 with the surface of the bone B, since the two contact points may be stable on uneven surfaces, even if 3, 4, or more contact points are unstable.

The guide 100 may include lateral clamping plates 112 and 114 (shown in fig. 10). Lateral cleats 112 and 114 may engage the surface of bone B to prevent guide 100 from rotating in direction θ about guide centerline CL_GAnd (4) rotating. The lateral cleats 112 and 114 may be resilient to allow some sliding over the bone B.

Alignment members 104 and 106 may be the first component of guide 100 to engage bone B when the practitioner positions guide 100 on bone B. Alignment members 104 and 106 may align guide centerline CL before contacts 108 and 110 and cleats 112 and 114 contact bone B_GBrought to the center line CL of the bone_BSAnd (6) aligning. Subsequently, in some embodiments, cleats 112 and 114 may engage bone B to inhibit rotation in direction θ. Subsequently, in some embodiments, the contacts 108 and 110 may be along the bone centerline CL_BSEngaging bone B. The contact portions 108 and 110 may have sharp points to provide a neutral line CL to the guide_GAnd the bone center line CL_BSFurther resistance to misalignment. In some embodiments, there may be no more than two contacts (e.g., 108 and 110) to ensure that the contacts are in contact with the bone centerline CL_BSIn line.

Guide 100 may include a handle 116 and a grip 118. The practitioner may manually grasp handle 118. In some embodiments, a torque limiter (not shown) may be positioned to limit the torque that a practitioner can apply to contacts 108 and 110 via handle 118.

The guide tube 120 may receive and guide any suitable instrument the guide tube 120 may be oriented at an angle α with respect to the handle 116 in some embodiments, the angle α mayIn some embodiments, guide tubes 120 may be oriented such that axis L of guide tube 120 is adjustable, including some embodiments in which α is adjustable and some embodiments in which α is non-adjustable_GTAt an axis L with the shank 116_HSubstantially the same location intersects bone B. The handle 118 will thus be positioned directly on the center of the hole site H'.

Guide 100 may include channels 142 and 144 (shown in fig. 5). Rods 146 and 148 may be inserted through cortical bone B via passages 142 and 144, respectively_CO. Rods 146 and 148 may stabilize guide 100 on bone B. The rods 146 and 148 may be k-wires. The rods 146 and 148 may be inserted using a wire drill.

Figure 2 illustrates anatomical features of a fractured bone. Frame of reference 200 shows a view of bone B lying substantially in an anterior/posterior plane 200. The transverse plane 204 includes a vola half and a DOR half.

Bone B is shown at crack F_hAnd F_aThe cracked radius. Bone B comprises a bone portion P_b、P_hAnd P in the distal end D_a. Bone segment P_bIs the largest part of bone B. Bone segment P_hIs the head portion of bone B. Bone segment P_hAnd P_aIncluding the articular surface AS. Bone part P_b、P_hAnd P_aAlong the crack F_aAnd F_hSeparated or partially separated. Crack F_aTransverse to the joint surface AS. Crack F_hTransecting the head of bone B.

To include a substantially longitudinal axis L_BThe cross section of which shows that the bone B comprises cortical bone B_COAnd cancellous bone B_CA. Deployment of the implant within the distal portion D of bone B may require an access hole at site H'. Deployment of the implant may require cancellous bone B_CAAnd (4) shifting. Located in cancellous bone B_CAExemplary profile C of₁、C₂And C₃Is cancellous bone B_CADifferent profiles that can be shifted within. Contour C₄(which is the contour C₃Projection on the articular surface AS) shows the contour C₄For example, may be asymmetric. For example, the contour C₄May have a long axis A₁And a minor axis A₂(shown as half). Other profiles may also be asymmetric.

The devices and methods provided herein can provide an access hole H at site H'. A device inserted through access hole H at site H' may be translated across intramedullary space IS by a distance x_HTo reach the head portion of bone B. A device inserted through access hole I at site I' may be translated across intramedullary space IS by a distance x_ITo reach the head portion of bone B. A device inserted at H' may need to "bend" to translate through the intramedullary space IS to reach the head portion of the bone B. The device inserted at I' may not need to "bend" to reach the head portion of bone B. The devices and methods provided herein can provide cancellous bone B_CAIn the profile (e.g. C)₁、C₂Or C₃) And (4) inner displacement.

Fig. 3 shows the guide 100 from the side, positioned at the location H' where the access hole is provided. Guide plate 130 is positioned to position the broach (having profile 134) and drill (having profile 136) with target region R_tAnd (4) aligning. The guide plate 132 extends perpendicular to the plane of fig. 3. Fluoroscopy may be used to base cancellous bone B in bone B_CAAnd cortical bone B_COThe contour of (shown in fig. 2) picks up the target area. A rod, such as a k-wire, may be inserted through hole 302 and bone B to fix the position of guide 100 relative to bone B.

Fig. 4 shows the guide 100 positioned at the location H' (not shown) from the top. The guide plate 132 is positioned to position the broach (having profile 138) and drill (having profile 140) with the target area R_tAnd (4) aligning.

A guide plate 132 extends from the base of the handle 118.

The arm 404 supports the fence 130, the fence 130 extending perpendicular to the plane of FIG. 3. Fluoroscopy may be used to base cancellous bone B in bone B_CA(shown in FIG. 2) and cortical bone B_COThe contour of (shown in fig. 2) picks up the target area. A rod, such as a k-wire, may be inserted through hole 402 and bone B to fix the position of guide 100 relative to bone B.

A cannula 406 IS positioned in the guide tube 120 for delivery of instruments to the intramedullary space IS (shown in fig. 2) of the bone B.

Fig. 5 shows the guide 100 positioned at the site H' from above and from behind. H' is generally along the axis L of the guide tube 120_GTAnd (4) centering. The distal portions of rods 146 and 148 penetrate bone B to maintain the position of guide 100. The rods 146 and 148 may be inclined to each other. The levers 146 and 148 may be deflectable relative to each other.

Fig. 6 shows the drilling tool 600 inserted into the guide tube 120 and penetrating the bone B. The drilling tool 600 can penetrate the cortical bone B_CO(shown in FIG. 2) and cancellous bone B_CA(shown in FIG. 2). The drill 600 may include teeth 602, grooves 604, a shaft 606, a torque adapter 608, and any other suitable structure. The torque adapter 608 may be an A-O type torque adapter or any other suitable torque adapter. A stop 610 may be provided to limit the penetration depth d of the drilling tool 600_P. The stop 610 may be any suitable structure that limits the forward axial movement of the member 600. The stop 610 may include an annular distal surface 612, and the annular distal surface 612 may reach d_PAnd abuts the flange 614 of the guide tube 120. A fastener 616, which may be a set screw, may be used to fix the position of the stop 610 along the shaft 606 to fix d_PThe size of (2).

Fig. 7 shows an exemplary intramedullary broach 700. Broach 700 may include broach head 702. Broach head 702 may include exemplary broaching members 704.

The broaching member 704 may be sufficiently rigid to create cancellous bone B_CAAnd (4) shifting. Broaching member 704 may be flexible enough to be cut by cortical bone B_COAnd (5) deforming. In some embodiments, broaching member 704 may be expandableAnd (4) unfolding. The pull bit 702 may be supported and rotated by the shaft assembly 714. Broach control portion 706 may include a drive handle 708 for rotating and translating broach head 702. Broach control portion 706 may include an expansion control interface 710. Expansion control interface 710 may be displaced along the control axis to expand or contract broaching member 704. The pulling head 702 may include a distal portion 780. The expansion control interface 710 is shown in a "collapsed" position.

Fig. 8 shows broach 700 deployed through hole H in bone B. Broach 700 may be deployed when broaching member 704 is retracted.

Broach head 702 may be advanced through intramedullary space IS into diaphyseal region M of bone B. Broach head 702 may be positioned in any portion of intramedullary space IS, such as the bone ends.

The proximity hole H may be small enough to reduce the induced stress gradient (riser) at site H'. Expansion control interface 710 is shown in an "expanded" position and broaching member 704 is shown expanded in bone B. Broaching member 704 may be expanded during or after deployment.

A standard bone drill (not shown) may be used to open cortical bone B at site H' of bone B_COAn access hole H in (shown in FIG. 2.) the drilling tool may be guided by a means, such as guide 100 (shown in FIG. 1.) an axial hole H may be drilled along broach axis LC. broach axis LC may form an angle β with bone axis LB the broach 700 may be positioned such that broach axis L_CSubstantially coincident with the guide tube axis LGT (shown in fig. 1) angle β may be an acute angle β may be complementary to angle α (shown in fig. 1).

Fig. 9 shows an exemplary instrument guide 900 at site H' on bone B. Implement guide 900 may have one or more features in common with implement guide 100 (shown in fig. 1). Implement guide 900 may include implement guides 930 and 932 for positioning implement guide 900 to enable positioning of an implement at target area St 1.

The exemplary steerable broach 950 may be deployed in a target region S located in the intramedullary space IS by insertion through the guide 900 at location H_t1To (3). Broach 950 may include broach head 925. Broach head 925 may have one or more of the same features or attributes as broach head 125 (shown in fig. 1). Broach head 925 may be supported by broach sheath 927. Broach head 925 may be rotated by drive shaft 940, drive shaft 940 may extend inside broach sheath 927 and receive torque from torque adapter 908. The torque adapter 908 may provide rotation of the drive shaft 940 from any suitable source of rotation.

Broach sheath 927 may be flexible. The broach sheath 927 may be flexible in region 928 such that off-axis tension applied by elevator tape 952 may pull the tool head 925 relative to the bone axis L_BPositioned at a distance y or-y. The example elevator control body 960 may apply an axial compressive force to the elevator belt 952 to cause the broach sheath 927 to bend.

The broach sheath 927 may be configured to curve in more than one plane. The broach sheath 927 may be configured to curve substantially in only one plane.

Target area S_t1Can be positioned in cancellous bone B_CAAnd cortical bone B_COEither or both (shown in fig. 2). Side guides 930 and top guide 932 are aligned with guide tube 920. The practitioner may position the guides 930 and 932 such that the guides 930 and 932 "project" onto the target area S_t1So that guide 900 will guide broach head 925 to target area s_t1。

The side guide 930 may be rotated at the arm 942 to change the axis L of the side guide 930_TWith the centre line CL of the guide 900_GTThe angle gamma therebetween. γ may be selected to correspond to the degree of lift in the direction y or-y of the broach head 925. γ may be chosen to correspond to the degree of actuation of the control portion 962 of the control body 960. For example, γ may be chosen such that the side guide 930 "projects" onto the target area St 2.

Fluoroscopy may be used to position the guides 930 and 932 relative to the target area St 1.

The practitioner can select the position of H' (distance x shown in FIG. 2)_H) The angle of hole H relative to bone axis LB (shown in fig. 2), the degree and distribution of curvature in region 928, the penetration of broach sheath 927, the size of broach head 925, the swept profile of broach member 924, and any other suitable parameters to determine the size, shape, orientation, and location of the bone cavity that will be swept by broach member 924. For example, one or more of the foregoing parameters may be selected to position broach head 925 in target area St 2.

Fig. 10 shows the guide base 102 on the distal end side from below. A stem 116 extends from the top of the base 102. A guide tube 120 extends from the distal portion of the base 102. The arms 131 extend from the sides of the base 102. The location H' of the hole H (shown in FIG. 2) is shown projected onto the opening 1002 of the guide tube 120 and centered about the axis LH and LGT.

Exemplary contacts 108 and 110 extend downward from base 102 to engage bone B (shown in fig. 2) and resist rotation about vertical axis L_HAnd L_TRAnd along the guide centerline CL_GTo (3) is performed. The contact portions 108 and 110 may be sharp enough to penetrate or partially penetrate the bone B. The cleats 112 and 114 may engage the surface of the bone B and resist rotation about the guide centerline CL_GThe rotation of (2). The base 102 may support any suitable number of contacts in any suitable pattern or location. The base 102 may support the guide member along a centerline CL that is substantially oblique or transverse to the guide member centerline CL_GIs arranged in contact extending in the direction of (a).

In some embodiments, the base 102 may include a flange (not shown) that bears against the bone B. The flange may include any suitable number of contacts in any suitable pattern, including along a line that is substantially oblique or transverse to the guide centerline CL_GIs arranged in contact extending in the direction of (a).

Alignment members 104 and 106 may be removed from the base102 extend to align guide centerline CLG of guide 100 with bone centerline CL of the top surface of bone B (shown in fig. 2)_BSAnd (4) aligning. Each of alignment members 104 and 106 includes a continuous alignment edge 1004 and 1006. The rim 1004 is supported by generally vertical struts 1007 and 1008. The rim 1006 is supported by generally vertical struts 1010 and 1012. Edges 1004 and 1006 are substantially parallel to centerline CLG.

In some embodiments, the alignment member may be or may include tines that correspond to the posts 1007, 1008, 1010, and 1012. One or more of the tines may extend vertically downward from the base 102. One or more of the tines may extend downward and in a proximal direction relative to the base 102. One or more of the tines may extend downward and in a distal direction relative to the base 102.

In embodiments that include one or more tines (not shown), edges 1004 and 1006 may be absent. In these embodiments, the tines can flex independently of one another. One or more of the tines may be biased away from the guide centerline CLG. One or more of the tines may be biased toward the guide centerline CLG. One or more of the tines may be curved or arcuate.

Some embodiments may include a sleeve (not shown) located within the guide tube 120. The sleeve may provide stability to the k-wire during surgery where the k-wire is used as a drill to provide initial access to the inside of the bone.

Fig. 11 illustrates an exemplary saw 1100. Saw 1100 may be used to cut an access hole or any other suitable hole at either site H 'or site I' (shown in fig. 2). Saw 1100 may be guided by guide 100 (shown in fig. 1), guide 900 (shown in fig. 9), guide 1900 (shown in fig. 19), or any other suitable guide.

The saw 1100 may include a wire 1102. The wire 1102 may be k-wire or any other suitable wire. Saw 1100 may include centering sleeve 1104. Centering sleeve 1104 may be made of a polymer, an alloy, or any other suitable material. Saw 1100 may include a cutting member 1106. Cutting member 1106 may include teeth 1108, vents 1110, and cylindrical member 1112. Vents 1110 may provide debris removal, side cutting, reduced heating or other features, and the like. Saw 1100 may include a torque adapter 1114. The torque adapter 1114 may transfer rotation from the rotation source 1102 to one or both of the k-wire 1102 and the cutting member 1106.

The wire 1102 may form an angled guide hole in bone B. The holes may be in the saw axis L_STo the bone axis L_BFormed at an angle therebetween. After the wire 1102 penetrates the bone B, the saw 110 may be advanced distally until the teeth 1108 engage the bone B and a cut will be made. The tooth 1108 will first engage bone B at point p at the bifurcation between the wire 1102 and bone B. Teeth 1108 may thus experience contact forces from bone B that are oblique to the plane defined by teeth 1108. Centering sleeve 1104 may support teeth 1108 against the tilting forces and maintain teeth 1108 from axis L during formation of the access hole_SAt a substantially constant radius.

A spring 1116 (shown in fig. 13) may urge the centering sleeve 1104 distally to hold the centering sleeve 1104 at or near the bone B as the teeth 1108 are passed into the bone B.

Fig. 12 shows that the centering sleeve 1104 may be coaxially disposed within the cutting member 1106. The wire 1102 may be coaxially disposed within the centering sleeve 1104. The collar 1202 of the centering sleeve 1104 may be positioned at the distal end of the centering sleeve 1104 to provide a close tolerance between the wire 1102 and the centering sleeve 1104.

Fig. 13 shows the spring 1116 compressed between the proximal face 1302 of the centering sleeve 1104 and the distal face 1304 of the torque adapter 1114.

In some embodiments, the wire 1102 may be used to drill a pilot hole in bone B without the centering sleeve 1104 and cutting member 1106, for example. In such an embodiment, a sleeve (not shown) may be positioned in a guide tube, such as guide tube 120 (shown in fig. 1). The wire 1102 may be disposed through the sleeve and driven by a torque adapter (e.g., 1114). The sleeve may have a bore sized to stabilize a k-wire rotationally driven by a surgical drill.

It may then be desirable to cut a hole in the bone that is substantially coaxial with the k-wire. In such an embodiment, after the k-wire is drilled into the bone, the sleeve (not shown) may be removed from the guide tube to allow the coring saw to be advanced through the guide tube.

Fig. 14 shows an exemplary device 1400 for cutting a hole in bone B substantially coaxial with wire 1402. Fig. 14 shows relevant portions of coring saw guide 1450. Coring saw guide 1450 may include a contact 1452 for engaging a surface of bone B (shown in fig. 2). Coring saw guide 1450 may include a handle mounting recess such as 1454. A centering sleeve (not shown) may be coaxially disposed between wire 1402 and cutting member 1406. In some embodiments, the cutting member (e.g., 1406) may be engaged by a collar (not shown) configured to transmit torque.

The proximal end of wire 1402 may be engaged in the manual drilling joint and rotatably driven into the bone as it is advanced distally through saw guide 1450.

Fig. 15 shows a wire 1402. Distal end 1502 of wire 1402 may have a first diameter. The proximal end 1504 of the wire 1402 may have a second diameter that is larger than the first diameter. Step 1506 between the first diameter and the second diameter may act as a stop to limit the extent to which wire 1402 may be driven into bone B.

The proximal end 1504 of the wire (e.g., 1402) may extend along and through a cannula in an a-O adapter when the adapter drives the cutting member (e.g., 1408) distally into the bone.

In some embodiments, step 1506 may be used to distally expel a bone plug from the interior of distal portion 1405 of cutting member 1406 after a hole is cut and cutting member 1406 is withdrawn from the tube.

In some embodiments, soft tissue guards (not shown) may be provided to hold soft tissue proximate the access holes out of engagement with the rotating device. The guard may comprise a sleeve for guiding the rotation means into the bore. The guard may include a flange that "funnels" the device into the cannula and prevents soft tissue from accessing the device.

Fig. 16 shows a portion of an exemplary cutting member 1106 from region 16 of fig. 11. Circumferential teeth 1602 may extend into one or more of the ejection ports 1110 to engage bone on the inside of the cutter.

The teeth 1602 may provide friction between the cutting member 1106 and the bone peg and may facilitate removal of the bone peg when the cutting member 1106 is withdrawn from the access hole. The distal portion of the plug may not be severed from the native tissue of bone B by the cutting member 1106. The teeth 1602 may provide one or both of a torsional force and an axial force to sever the bone peg from the bone B. Vent 1110 may include a vent edge 1604. The discharge port edge 1604 may cut the wall proximate the hole.

The teeth 1602 may provide friction between the cutting member 1106 and the centering sleeve 1104. The friction may resist proximal movement of the centering sleeve 1104.

Fig. 17 illustrates exemplary teeth 1108 of cutting member 1106 (shown in fig. 11). Exemplary tooth 1702 may include a cutting edge 1704, a cutting face 1706, and a cutting back 1708. Cutting face 1706 and cutting back 1708 may partially define adjacent gullets 1710 and 1712, adjacent gullets 1710 and 1712 being interposed between tooth 1702 and adjacent teeth 1714 and 1716, respectively. Teeth 1702 may have a thickness t. Tooth 1702 may be circumferentially set apart from adjacent tooth 1716 by a pitch P_t. The cutting edge 1704 may be oriented in a radial direction R relative to the saw_sAt an inclination angle phi (shown on different teeth). Cutting edge 1704 is shown as having φ =0 °, but any suitable φ may be used. The cutting face 1706 may have a rake angle ρ.

A larger rake angle (e.g., positive) may produce a lower force, but a smaller tooth angle and thus lower heat capacity. A smaller rake angle (e.g., negative) may increase heat capacity and increase the amount of heat generated in shear but increase cutting force.

The cutting face 1706 is shown as having ρ =0 °, but any suitable ρ may be used. Gullet 1710 may have a gullet depth D_g。

In some embodiments, teeth 1702 may include facets 1718 (shown in phantom). When facet 1718 is present, tooth face 1706 may be shortened by distance h. Facet 1718 may have a normal (not shown) with respect to axis L_SAnd a radius R_SOriented at any suitable angle.

FIG. 18 shows tooth 1108 (shown in FIG. 11) as viewed along line 18-18 (shown in FIG. 17). The cutting edge 1704 forms an angle θ with the saw outer wall 1802. Cutting edge 1704 is shown as having θ ≈ 90 °, but any suitable θ may be used. For example, by following the chord line Ch₁May be formed with a tooth having a tooth angle theta>A 90 deg. cutting edge. By following the chord line Ch₂May be formed with a tooth having a tooth angle theta<A 90 deg. cutting edge.

In some embodiments, the cutting member may have bi-directional cutting teeth. Each of such teeth may have a right cutting edge and a left cutting edge. When the coring saw rotates clockwise, the right edge cuts. When the coring saw is rotated counterclockwise, the left edge performs cutting.

Fig. 19 illustrates an exemplary instrument guide 1900. Exemplary instrument guide 1900 may have one or more of the same structures as guide 100 (shown in fig. 1) and guide 900 (shown in fig. 9). Guide 1900 may be used to guide an instrument into bone B at a site such as H 'or I' (shown in fig. 2).

Guide 1900 may include a base 1902. Base 1902 may be arranged to abut bone B at site H' (in fig. 2)Shown). Base 1902 may include contacts (not shown), alignment members (not shown), cleats (not shown), or any other suitable structure. Handle 1918 may extend from base 1902. Base 1902 may include a pivot 1904. Pivot 1904 may pivotally support guide tube 1920. Center line CL of guide tube 1920_GT′Can be positioned relative to the axis L_H′At any suitable angle α 'such that saw 1950 may be advanced through bone B (not shown) at angle α'_H′And CL_GT′May be substantially the same as site H ' or site I ' the practitioner may change the angle α ' before or during penetration of the saw 1950 through the bone B, for example, the practitioner may start with a pilot hole α ' ≈ 0 ° and then change α ' to obtain the desired angle for access to the hole.

The saw 1950 may include teeth 1952, grooves 1954, sleeves 1956, or any other suitable structure, including those described and illustrated herein in connection with other saws.

Fig. 20 shows a view of the distal portion of broach 700 taken along line 20-20 (shown in fig. 7). The pin 703 may be positioned near the distal end of the bracket 720. Pin 703 may fix the position of the distal end of broaching member 704. Pin 703 may support cylindrical formation 705. Cylindrical formation 705 may be mounted coaxially on pin 703. Cylindrical form 705 may support a helical section of broaching member 704. One or more distal portions of broaching member 704 may be welded or otherwise suitably secured to cylindrical form 705.

Cylindrical form 705 may limit or partially limit the orientation of the distal portion of broaching member 704. Cylindrical form 705 may be fixed relative to bracket 720. Cylindrical form 705 is rotatable relative to bracket 720.

The broach head 702 may include an end cap 701. Broaching member 704 may remove tissue substantially adjacent to end cap 701. In some embodiments, member 704 may expand to extend distally from end cap 701. In such an embodiment, the broaching member may remove tissue distal to endcap 701.

Reducing or decreasing the distance between the distal end of broaching member 704 and end cap 701 enables broaching member 704 to remove tissue closer to end cap 701. End cap 701 may be positioned at the distal end of stent 720. End cap 701 may be configured to have a smooth and atraumatic surface. The bracket 720 may be attached to a drive shaft 730.

The shaft assembly 714 may include a drive shaft 730. The drive shaft 730 may support the bracket 720 at a joint 732. Drive shaft 730 may be secured to bracket 720 by pin 734. The drive shaft 730 may provide rotation to the broach head 702.

Proximal ends 736 and 738 of broaching member 704 may be fixed to slide 740, which slide 740 may be a tube. The proximal end 738 may be threaded through or keyed into windows 742 and 744 in the slider 740. The proximal end 736 can be threaded or keyed into slots 746 and 748 in the slide 740. Slide 740 may slide relative to drive shaft 730 to expand and contract broaching member 704. Slide 740 is shown in a "retracted" state, wherein broaching member 704 is pulled close to stand 720. The slide cover 750 may slide together with the slide 740. One or both of slide 740 and slide cover 750 may be controlled along axis L by control interface 710 (shown in FIG. 7) or any other suitable positioning control_CAnd (4) translating.

The sliding cover 750 may remain stationary relative to the drive shaft 730 as the slider 740 slides relative to the drive shaft 730. In embodiments where slide cover 750 remains stationary as slide 740 moves, distal end 752 of slide cover 750 may define the radial position of broaching member 704 at a fixed distance along drive shaft 730 and thereby affect the deformation of broaching member 704 in the expanded state.

Broaching member 704 may undergo one or both of elastic and plastic deformation.

Fig. 21 illustrates a view of the distal portion of broach 700 taken along line 20-20 (shown in fig. 7) when broaching member 704 is in the expanded state. Broaching member 704 is shown as being primarily circular. However, any desired shape can be imparted in the expanded state, such as, but not limited to: square, triangular, oval, elliptical, teardrop, football, or any other suitable shape.

Several methods can be used to obtain different shapes, for example: utilizing a predetermined shape of the shape memory alloy; changing the geometry of the member cross-section (along the member length) so that it is preferably curved in a desired manner; constraining broaching member 704 in a manner that forces expansion (e.g., by force, shear stress, or moment) so as to achieve a desired shape; bringing the final shape to the shape of an expanded geometry and the reduced or contracted geometry to the shape of a higher stress configuration; and/or any other suitable method of forming a desired shape.

For example, largely or substantially preventing radial movement of proximal ends 736 and 738 of broaching member and permitting movement of the distal end of broaching member 704 substantially about pin 703 while elastically deforming proximal ends 736 and 738 of broaching member (due to the reduced distance between the distal and proximal ends 736 and 738 of broaching member 704) may change the geometry of broaching member 704 from a substantially linear configuration to a substantially whisk shape.

The deformation may relatively increase the distance between (a) segments 760 and 762 and (b) bracket 720. As this distance increases, the swept volume of broaching member 704 (as broaching member 704 is generally centered about an axis, such as L)_C(shown in fig. 8) is rotated).

In some embodiments, the broaching tool may include broaching members that include one or more pointed tines (not shown) engaged to the drive shaft. The drive shaft may have a longitudinal axis. The tines may be joined to the drive shaft radially proximate the axis at the proximal end of the tines. The tines may have a distal end radially spaced from the axis. The distal end of the tines may be distal to the distal end of the drive shaft. A plurality of tines may be provided on the drive shaft. Such an embodiment may be suitable for rotation in the intramedullary space IS of the bone B (shown in fig. 2) using low rotational speeds and high torque.

Fig. 22 illustrates broaching member 704 in partial cross-section as viewed from line 22-22 (shown in fig. 21). Broaching member 704 may have leading edges 2202 and 2204, and leading edges 2202 and 2204 may be directed in direction ω by drive shaft 730 (shown in FIG. 21)_CAnd (4) rotating. Broaching member 704 may sweep out of bone B (shown in FIG. 2) based on radius R_CSpace of (2), radius R_CCorresponding to sections 760 and 762 (shown in fig. 21).

The leading edge 2202 may be at an angle α_c1Angle α of inclination_c1Can be any suitable angle, including an angle from about 5 to about 75 angle α_c1The leading edge 2202 may be caused to be generally sharp or knife-like. This may assist the broaching member's ability to remove tissue.

Leading edge 2204 may be at angle α_c2Angle α of inclination_c2Can be any suitable angle, including an angle from about 5 to about 75 angle α_c2Leading edge 2204 may be caused to be generally sharp or knife-like. This may assist the broaching member's ability to remove tissue.

When broaching member 704 is substantially about axis L_CIn clockwise rotation, leading edges 2202 and 2204 may approximate a first portion of segments 760 and 762 to engage tissue (e.g., lesser density cancellous bone B)_CA(shown in fig. 2)) are in contact. Segments 760 and 762 can be configured to be sufficiently flexible such that, if either of segments 760 and 762 contacts a more dense material (e.g., diaphyses, metaphysis, and epiphyses), segments 760 and 762 can be at any location along the length of segments 760 and 762 or any other portion of broaching member 704 along axis L_CDirection-omega of_CDeflecting substantially radially and/or in a linear direction towards axis L_CAnd (4) deflecting. The deflection or deformation of sections 760 and 762 may have the effect of not interfering with the greater density of tissue.

The leading edges 2202 and 2204 may be aligned from the axisL_CDeviation of each by₁、Δ₂The amount of offset of (c). The offset Δ may be chosen₁And Δ₂Of a suitable size. In some embodiments, the offset Δ₁And Δ₂May be formed from a contracted configured diameter (when broaching member 704 is contracted (e.g., for deployment), broach head 702 is transverse to axis L_CTotal diameter in the plane of) and the desired expanding engagement (radius R) of broaching member 704 with tissue_C) And (4) limiting. Offset delta₁And Δ₂The efficiency of the broaching member in displacing tissue may be facilitated.

Fig. 22A shows broach head 704 located in intramedullary space IS of bone B and illustrates how the flexible broaching member IS capable of broaching relatively lower density bone and IS deflected by higher density bone. Sections 760 and 762 have passed in direction ω_CAbout an axis L_CTo make cancellous bone B_CASome of which are displaced or removed from bone B. Sections 760 and 762 may be sufficiently rigid to hold cancellous bone from axis L_CRemoved to a radius R located in the "top" portion of bone B_CTo (3). Due to the axis L_CDisplacement relative to the floor of bone B, therefore sections 760 and 762 contact cortical bone BCO at the floor of bone B. The sections 760 and 762 may be sufficiently flexible to be deflected by cortical bone BCO. Section 760 is shown as being bounded by bone BCO in direction- ω_cAnd (4) deflecting. Sections 760 and 762 thus remove bone only to radius R located in the "bottom" portion of bone B_cAt' point.

The bone cavity created by the broach 700 may thus be bounded in part by cancellous bone BCA and in part by cortical bone BCO. The shape of the portion of the bone cavity bounded by the cancellous bone BCA may be substantially controlled by the geometry and mechanical properties of the broach 700. The shape of the portion of the bone cavity bounded by the cortical bone BCO may be substantially controlled by the native anatomy of bone B.

Fig. 23 shows a view of broach 700 along line 23-23 (shown in fig. 20). The broach 700 is in the retracted state. The slider 750 has been removed. The slots 746, 748, and 2302 in the slider 740 may be configured to communicate with the broaching member 704Is consistent with the structure on the proximal end portion 736 (shown in fig. 21). The slots 746, 748, and 2302 can constrain the proximal end portion 736 substantially along the axis L when the proximal end portion 736 is engaged with the slots 746, 748, and 2302_CIn either direction. The slots 746, 748, and 2302 can have any suitable geometry that permits engagement and axial translation of the proximal end 736.

The slots 746, 748, and 2302 can be of sufficient depth such that when the proximal end 736 is engaged into the slots 746, 748, and 2302, the slide cover 750 (shown in fig. 20) has sufficient radial clearance relative to the proximal end 736 and the slide 740 to slide over the slide 740 and the slots 746, 748, and 2302. The inner surface of the sliding cover 750 may prevent the proximal portion 736 from moving generally away from the axis L_CIs moved in the direction of (1).

The slider 740 can include a slot (not shown) that corresponds to the proximal end portion 738 (shown in fig. 20) and has one or more features in common with the slots 746, 748, and 2302.

Broach head 720 may include broach member wrapping section 2304. Pin 703 may be integral with wrapping section 2304. The wrapping section 2304 may be separate from the pin 703. Winding section 2304 may be configured to allow broaching member 704 to be wound substantially around winding section 2304. Broaching member 704 may form loops in wrapping section 2304. Broaching member 704 may be wound (as shown in fig. 23) in winding section 2304 for at least one complete turn. Wrapping around wrapped section 2304 may bias sections 760 and 762 (shown in fig. 21) away from axis LC.

Fig. 24 shows a cross-section of a portion of broach control portion 706 (shown in fig. 7) viewed along line 24-24 (shown in fig. 8). The extended control interface 710 is shown with a position at position p_eA base 2402. This may correspond to the expanded state of broaching member 704 as shown in fig. 8. Base 2402 may be moved distally to position p_c. This may correspond to the contracted state of broaching member 704 as shown in fig. 7. The expansion control interface 710 may operate in conjunction with the ontology 2408. Body 2408 may include a control shaft 712 and a distal tipAn end stop 2410. The control shaft 712 may include a threaded portion 2418.

Expansion control interface 710 may include an outer member 2412 and an inner member 2414. The outer member 2412 and the inner member 2414 may be secured to one another. The slide pin 2404 may be captured between the outer member 2412 and the inner member 2414. The inner member 2414 may include a threaded portion 2416 for engaging a threaded portion 2418 on the control shaft 712. Slide pin 2404 may translate in slots 2405 and 2407 in body 2408.

The extended control interface 710 may be along the axis L by applying a force to the extended control interface 710_CAnd (4) moving. In some embodiments, the extended control interface 710 may be controlled by applying a force to the extended control interface 710 generally about the axis L_CSubstantially along the axis L_CAxially advancing causes threaded portion 2416 to advance or retract through threaded portion 2418.

Axial movement of the expansion control interface 710 relative to the body 2408 may be transferred to the slider 740 and the slide cover 750 while the drive shaft 730 remains axially fixed to the body 2408 by the pin 2406. The slide 740 may include cut-outs 2430 and 2432. Slide cover 750 may include cut-outs 2434 and 2436. Cut-outs 2430, 2432, 2434, and 2436 may provide clearance for pin 2406 when slide 740 and slide cover 750 are moved axially.

As the expansion control interface 710 moves axially, the proximal ends 736 and 738 of the broaching member 704 (shown in fig. 20) move axially thereby. The distal end 780 (shown in fig. 7) of the broaching member 704 may be axially secured to the drive shaft 730, and the drive shaft 730 may be secured to the body 2408. Thus, as the expansion control interface 710 moves distally, the distance between (a) the proximal end portions 736 and 738 and (b) the distal end portion 780 decreases and the broaching member 704 expands. As the expanded control interface 710 moves proximally, the distance between (a) the proximal end portions 736 and 738 and (b) the distal end portion 780 increases and the broaching member 704 contracts.

The distal stop 2410 and the proximal stop 2420 may limit axial movement of the expansion control interface 710. Although proximal stop 2420 is shown as being part of handle 708, proximal stop 2420 may be separate from handle 708.

Handle 708 may be generally about axis L_CIs transmitted to the control shaft 712. The control shaft 712 may transmit rotation to the slide pin 2404 and the drive shaft 2406. Slide pin 2404 may transmit the rotation to slide 740 and slide cover 750. Drive pin 2406 may transmit the rotation to drive shaft 730, and drive shaft 730 may drive broaching member 704 (shown in fig. 21).

The distal stop 2410 is shown as being integral with the body 2408, but the distal stop may be a separate element attached to the control shaft 712 or a different portion of the body 2408.

Pin 2406 may extend into recess structure 2422. Recess structure 2422 may be a through hole. Pin 2406 may extend through the through hole to a location external to body 2408.

Pin 2404 may extend into recess structure 2424. Recess structure 2424 may be a through hole. Pin 2404 may extend through the through hole to a location external to body outer member 2412. The recess structure may be about an axis L_CExtending circumferentially. If recess structure 2424 is about axis L_CExtending circumferentially, the extended control interface 710 may be substantially unconstrained or constrained about the axis L by the pin 2404_CAnd (4) rotating.

Body 2408 may include a circumferential recess 2426. Recess 2426 may be sized to engage O-ring 2428. Recess 2426 may prevent interference between body 2408 and O-ring 2428 substantially along axis L_CTo the axial direction of the shaft. O-ring 2428 may be sized to provide an interference fit with outer member 2412. The interference fit may create friction between the O-ring 2428 and the expansion control interface 710. Friction may allow the expansion control interface 710 to be lightly locked relative to the body 2408 generally about the axis L_CAny rotational position of (a).

Fig. 25 shows a bone cavity preparation device 2500. Device 2500 can include broach 2550. Broach 2550 may have one or more features in common with broach 950 (shown in fig. 9). Broach 2550 may include one or more of broach head 2525, elevator ribbon 2552, and control body 2560. Device 2500 may include guide 2502. Guide 2502 may guide broach 2550 or any other suitable device through an access hole such as H or I (shown in fig. 2). Guide 2502 may retain soft tissue at a distance from the access aperture to prevent soft tissue from engaging instruments positioned in guide 2502.

Fig. 26-29 show the structure of different parts of the device 2500.

Fig. 26 shows an exemplary broach head 2525 and an exemplary elevator ribbon 2552 in partial cross-section.

The broach head 2525 may be rotated about the axis L by a rotary drive shaft 2540_EAnd (5) driving. Broach head 2525 may include broaching member 2524, and broaching member 2524 may have one or more features in common with broaching member 704 (shown in fig. 7). Broach head 2525 may include a distal hub 2526 and a proximal hub 2528. One or both of distal hub 2526 and proximal hub 2528 may transmit the rotation to broaching member 2524. One or both of distal hub 2526 and proximal hub 2528 may support broaching member 2524.

Drive shaft 2540 can extend within broach sheath 2527. Drive shaft 2540 may be rotatably supported by sleeve 2530 at the end of broach sheath 2527.

The example elevator ribbon 2552 may be anchored to a broach sheath 2527 at a fixture 2532. When being roughly along the axis L_EWhen an axial compressive force is applied to the elevator ribbon 2552, the elevator ribbon 2552 can buckle along its length. For example, elevator ribbon 2552 may be buckled at or near section 2534. Section 2536 may be used to support broach sheath 2537 in cancellous bone B relative to bone B (shown in fig. 2)_CAOr cortical bone B_COIn the raised position.

Portions of elevator ribbon 2552 can extend inside broach sheath 2527 and through slots 2542 and 2544 to section 2534. In some embodiments, there may be contact between the drive shaft 2540 and the elevator belt 2552. In some embodiments, there may be no contact between the drive shaft 2540 and the elevator ribbon 2552.

Elevator ribbon 2552, when compressed, can apply tension to adjacent portion 2538 of broach sheath 2527 and compressive force to opposing portion 2540 of broach sheath 2527. One or both of the tension of adjacent portion 2538 and the compression force of opposing portion 2540 can cause broach sheath 2527 to rotate substantially about an axis, e.g., L_FAnd (4) bending.

One or both of adjacent portion 2538 and opposing portion 2540 may include a stress relaxation structure that allows bending under tension and compression forces. The stress relaxation structure may comprise a slot or a pattern of slots. The stress relaxation structures may be positioned using laser ablation. Stress relaxation can provide a balanced curvature such that broach sheath 2527 bends when parked.

The stress relaxation structure may comprise sintered particles. The particles may comprise metal, polymer, composite material, or any other suitable material.

Fig. 27 shows an exemplary laser ablation pattern 2700 for a broach sheath, such as 927 (shown in fig. 9) or 2527 (shown in fig. 26). Mode 2700 (which is shown flat for illustration) can be cut in a cylindrical tube to relieve compression forces on one side of the tube and to relieve tension forces on the other side of the tube. For example, the compression relaxation mode 2740 can be positioned along an opposing portion 2540 of the broach sheath 2527. Tension relaxation mode 2738 can be positioned along adjacent portion 2538 of broach sheath 2527. The tension and compression relaxation can be achieved by respectively lengthening the length L_p1And L_p2But is increased. The bending stiffness can be increased by increasing the mode width w₁And w₂And decreases. Increasing the kerf and decreasing the cutting pitch may also decrease the bending stiffness. In some embodiments, the tube may have an outer diameter of 0.108 inches. In some embodiments, the tube may have a diameter of 0.125 inches. Any suitable outer diameter may be used.

Fig. 28 shows an example riser control body 2860. Elevator control body 2860 may support the proximal end of broach sheath 2527. The drive shaft 2540 may extend through the control body 2860 to the torque adapter 2808. Torque adapter 2808 may be hollow. Torque adapter 2808 may be a hollow a-O type adapter. The torque adapter 2808 may have a "D" shaped extension for engaging a D-clamp.

The torque adapter 2808 may be torqued by any suitable source of rotational energy.

The control body 2860 may include a housing 2862 and an actuator 2866. The handle 2864 may be used to cause the actuator 2866 to rotate relative to the housing 2862 about the axis L_TERotation angle_E. When the actuator moves by an angle_EAt this time, shaft 2868 may drive shuttle 2870 in slot 2872. The distal end of elevator ribbon 2552 may be secured to the shuttle, for example, by screws 2874. When the shuttle is in the distal position, elevator ribbon 2552 expands (as shown in fig. 26). When the shuttle is in the proximal position, elevator ribbon 2552 is retracted toward axis LE.

The actuator 2866 may include a face member 2890. The face member 2890 may be fixed relative to the housing 2862. The face member 2890 may include a recess 2892. The recess 2892 may "catch" a protrusion (e.g., 2894) to act as a detent (detent). Tab 2894 may be one of several tabs that provide a location for a lock key. For example, three detent positions may be located: forward, neutral, and backward. In the forward position, elevator ribbon 2552 is extended. In the rearward position, elevator ribbon 2552 is compressed. In the neutral position, elevator ribbon 2552 is in a partially compressed state.

The housing 2862 may be configured to house a torque limiter (not shown). A torque limiter may couple torque adapter 2808 to drive shaft 2540 and may be used to limit the torque applied to broach head 2525 (shown in fig. 25). If broach head 2525 becomes lodged in bone B (shown in fig. 2), the torque limiter may limit or reduce the torque exerted on broach head 2525 to prevent damage to broach head 2525, other elements of device 2500, other involved devices, or bone B.

Fig. 29 shows a guide 2502. Guide 2502 may include cannula 2904 and funnel 2906. Funnel 2906 may facilitate insertion of a broach head, such as 2525 (shown in fig. 25) into an aperture, such as H (shown in fig. 2).

Guide 2502 may be "preloaded" onto broach sheath 2527. The practitioner can insert the broach head into hole H (shown in fig. 2) and then position guide 2502 in hole H. Funnel 2906 may protect soft tissue located outside of bone B. Cannula 2904 may guide the broach head through hole H as it is withdrawn from hole H (e.g., upon completion of a bone cavity preparation procedure).

Outer wall 2908 of sleeve 2904 may be of a suitable diameter to substantially fill hole H. Funnel 2906 may include ledge 2910. Ledge 2910 may limit the extent to which cannula 2904 may extend into intramedullary space IS.

Sleeve 2904 may support detent 2910. Detent 2912 may be positioned to capture in cortical bone B_COOn the inside of wall W to hold sleeve 2904 in place in hole H. Detent 2912 may have a tapered profile so that it can engage walls W of different thicknesses. In some embodiments, detent 2912 may be passive. In passive embodiments, detent 2912 may be resilient, biased, or rigid. In some embodiments, detent 2912 may be active. In an active embodiment, detent 2912 may be actuated. For example, detent 2912 may be actuated by a manual control that causes detent 2912 to extend a desired or predetermined distance away from tube sleeve 2904. Cannula 2904 may include more than one detent.

The mouth 2914 of the funnel 2906 may have a transverse axis L_EAny suitable shape of (a). The shape may be rectangular, triangular, elliptical, teardrop, flared, circular, and any other suitable shape.

Funnel 2906 may include a skived curved section (not shown). The skived bend section may be located at the distal end of funnel 2906.

A guide for a rotatable broach may include a body having a sleeve. The body may support the broach sheath in alignment with the cannula. The drive shaft may pass through the cannula and extend distally through the broach sheath. The rotation source may be connected to the drive shaft adjacent the body. The body may be hand-held. The body may not be adapted to mate with a hole such as H (shown in fig. 2).

FIG. 30 shows device 2500 (shown in FIG. 25), with a larger angle_EAnd an elevator ribbon 2552 in a retracted state adjacent to broach sheath 2527. Stress relaxation structures such as those shown in straight model 2700 (shown in fig. 27) are shown in portions 2538 and 2540 of broach sheath 2527.

Fig. 31 illustrates an exemplary broaching member 3102. Broaching member 3102 may be mounted to hub 3106 by fastener 3104 at the distal end of broach shaft 3108. Broach shaft 3108 may have one or more structures in common with broach shaft 2527 (shown in fig. 26) or any other broach shaft discussed or illustrated herein. For example, broach shaft 3108 may include stress relaxation structures 3110 and 3112.

Interface 3106 may have one or more structures in common with structure 2528 (shown in fig. 26).

Broaching member 3102 may be a self-expanding structure. Broaching member 3102 may be constructed from a laser-cut tube that is expanded into a suitable shape (e.g., the shape shown). Broaching member 3102 may include broaching members such as 3114. Broaching member 3102 may include a plurality of interconnected units such as unit 3116. The cells may be defined by one or more broaching members. Some of the cells may be defined by structures other than broaching members. The cells may be arranged as a mesh. The cells may be connected such that when the structure is stressed (e.g., compressed) at one point, the stress is distributed to nearby cells. BroachingMember 3102 can thus be rotated in bone cavities having irregular shapes, such as non-circular, oblong, or angular. The bone cavity may be smaller than the diameter of broaching member 3102, such as expanded diameter D_E。

Broaching member 3102 may include a broaching member that includes braided wires (not shown). Broaching member 3102 may include a broaching member that includes braided bands (not shown).

In some embodiments, each cell arm may be a broaching member. When a large number of broaching members are provided during rotation of the broach head (i.e. when the circumferential density of the broaching members is high), less torque is required to drive the broach head.

Fig. 32 shows an exemplary broach 3200 inserted into bone B. Broach 3200 may include broach head 3202. The flexible rotary drive shaft 3204 may rotationally drive the broaching head 3202 in directions ρ 'and- ρ'. Drive shaft 3204 may be driven by a rotational source, such as handle 3206. In some embodiments, the rotary source may comprise a surgical hand-held drill, a DREMEL motor, or any other suitable source of rotary power.

Drive shaft 3204 may be enclosed in a flexible sleeve (spaced apart from broach sheath 3210, which will be described below).

Control body 3208 may be used to insert pulling head 3202 through a hole at location H'. During insertion, broach head 3202 may be retracted within flexible broach sheath 3210. A proximal end 3212 of flexible broach sheath 3210 may be secured to a distal end 3214 of control body 3208. Actuator 3216 may engage drive shaft 3204 and may slide relative to control body 3208. Actuator 3216 may thereby cause drive shaft 3204 to follow axis L_MTranslating within guide sheath 3210.

In some embodiments, broaching head 3202 may be compressible and expandable. The broaching head 3202 may be compressed within the guide sheath 3210. The broaching head 3202 may be expanded outside of the guide sheath 3210. In some embodiments, the broach head 3202 may self-expand in the bone B after being advanced out of the guide sheath 3210 by the drive shaft 3204. In some embodiments, when delivering the broaching head 3202 into the bone B, the broaching head 3202 may be positioned outside of the guide sheath 3210.

Broaching head 3202 may include one or more broaching members 3218, the one or more broaching members 3218 being sufficiently rigid to displace cancellous bone but sufficiently resilient to deform upon contact with cortical bone and thereby retain the cortical bone substantially in place.

Broaching member 3218 may be formed from a loop. The loop may be secured to the distal interface 3220. The loop may be secured to the proximal interface 3222. One or both of the distal 3220 and proximal 3222 interfaces may be axially fixed to the drive shaft 3204. One or both of the distal interface 3220 and the proximal interface 3222 may be rotatably secured to the drive shaft 3204. Broaching head 3202 may include any suitable number of loops. Broaching member 3218 may have one or more features in common with broaching member 704 (shown in fig. 7) or any other broaching member described or illustrated herein.

Fig. 33 illustrates an exemplary broach head 3300. Broaching head 3300 may include broaching members 3302. Each of broaching members 3302 may have one or more features in common with broaching member 704 (shown in fig. 7) or any other broaching member described or illustrated herein. Broaching head 3300 may have any suitable number of broaching members 3302. For example, the broaching head 3300 may have one broaching member, 2-6 broaching members, 7-20 broaching members, more than 20 broaching members, or any suitable number of broaching members.

The pulling head 3300 may be retracted toward the drive shaft 3310 and may be retracted into an outer sheath (not shown). The outer sheath may be inserted into a hole such as H (shown in fig. 2). The pulling head 3300 may then be deployed by retracting the sheath. The broaching member 3302 may be sufficiently resilient to contract and may expand away from the drive shaft 3310 as the sheath is retracted.

Broaching member 3302 may be supported by distal interface 3304. The distal interface 3304 may be absent and the broaching member 3302 may have a free distal portion. The broaching members with free distal portions may be supported at their proximal portions near the central axis of the broaching head 3300. The broaching members may be angled radially away from the central axis of the broaching head 3300.

The broaching member having a free distal end portion may have a suitable shape at the distal end portion, such as pointed, bifurcated, rounded, blunt, or truncated.

Broaching member 3302 may be supported by proximal hub 3306. The proximal hub 3306 may be supported by a broach sheath 3308. The broach sheath 3308 may have one or more structures in common with the broach sheath 127 (shown in fig. 1).

The drive shaft 3310 may rotatably drive the broaching head 3300. The drive shaft 3310 may extend distally to the distal interface 3304. The drive shaft 3310 may extend through the broach sheath 3308 to a proximal rotation source (not shown).

One or both of the distal and proximal hubs 3304, 3306 may be axially fixed to the drive shaft 3310. One or both of the distal and proximal interfaces 3304, 3306 may be rotatably secured to the drive shaft 3310.

One or more of broaching members 3302 may include hoop segments such as 3312. The section 3312 may support one or more reinforcements, such as 3314.

The section 3312 may be rigid. The segment 3312 may be resilient. The segment 3312 may have any suitable predetermined curvature or be substantially linear. Section 3312 may be a closed loop. The loops may be asymmetrical.

The section 3312 may comprise a length of wire, ribbon, cable, strand, or any other suitable form or structure. The section 3312 may comprise a polymer, metal, alloy, or any other suitable material. The section 3312 may be constructed of a mesh cut from a metal tube.

The reinforcement 3314 may be a tube. The reinforcement 3314 may be made of a polymer, metal, alloy, or any other suitable material. One or more enhancements, such as 3314, may be sized and positioned to support the desired contoured section 3312. One or more enhancements, such as 3314, may provide bone broach abrasiveness, dynamic forces, or both.

Fig. 34 shows an exemplary broach head 3400. Broaching head 3400 may include broaching members 3402. Each of broaching members 3402 may have one or more features in common with broaching member 704 (shown in fig. 7) or any other broaching member shown or described herein. For example, broaching head 3400 may have one broaching member, 2-6 broaching members, 7-20 broaching members, more than 20 broaching members, or any suitable number of broaching members.

Broaching member 3402 may be supported by distal interface 3404. Broaching member 3402 may be supported by proximal interface 3406. The proximal interface 3406 may be supported by the drive shaft 3410. The drive shaft 3410 can have one or more structures in common with drive shaft 730 (shown in fig. 20) or any other drive shaft shown or described herein.

Drive shaft 3410 may rotatably drive broaching head 3400. The drive shaft 3410 may extend distally to the distal interface 3404. The drive shaft 3410 may extend to a proximal rotation source (not shown).

One or both of the distal interface 3404 and the proximal interface 3406 may be axially fixed to the drive shaft 3410. One or both of the distal interface 3404 and the proximal interface 3406 may be rotatably secured to the drive shaft 3410.

One or more of broaching members 3402 may include hoop sections such as 3412. The reinforcement 3414 may support one or more segments, such as 3412.

Section 3412 may be rigid. The segment 3412 may be resilient. Section 3412 may include a length of wire, ribbon, cable, strand, or any other suitable form or structure. Section 3412 may include a polymer, a metal, an alloy, or any other suitable material.

The reinforcement 3414 may be a stent. The reinforcement 3414 may be made of a polymer, a metal, an alloy, or any other suitable material. One or more reinforcements, such as 3414, may be sized and positioned to support the desired contoured section 3412. One or more enhancements such as 3414 may provide bone broach abrasiveness, dynamic forces, or both.

The stent may reduce material fatigue in section 3412. The holder can help the segment 3412 retain its shape under rotational forces and drag forces. The holder may include loops 3418 and 3416. The loops may travel around the circumference of section 3412. In some embodiments, loops 3418 and 3416 may surround only a portion of the peripheral edge. In some embodiments, the posts can be secured to the segments 3412, such as by crimping, welding, or press-fitting.

The bracket may support a broach edge for displacing bone material in bone B (shown in fig. 2). The broaching edge may have any suitable form, such as a tooth, a serration, a blade, a linear edge, or any other suitable form.

The stent may be formed from a pattern cut into a metal tube.

Fig. 35 illustrates an exemplary broaching head 3500. Broaching head 3500 may include broaching member 3502. Broaching member 3502 may have one or more of the same structures as broaching member 704 (shown in fig. 7) or any other broaching member shown or described herein.

Broaching head 3500 may have any suitable number of broaching members such as broaching member 3502. For example, broaching head 3400 may have one broaching member, 2-6 broaching members, 7-20 broaching members, more than 20 broaching members, or any suitable number of broaching members. When more than one broaching member is included, the broaching members may have different sizes or other configurations.

Broaching member 3502 is illustrated as a single solid ferrule. Broaching member 3502 may include one or more members that are stranded or braided. Broaching member 3502 may include a wire, a strip, a plate, a strand, a ribbon, a polymer, a composite material, a ceramic, a sintered material, or any other suitable material. Broaching member 3502 can have one or more of various cross-sections, such as square, rectangular, octagonal, a profile with sharp edges, a strand, or other suitable configuration to facilitate bone displacement.

Broaching member 3502 can include stainless steel, nitinol (shaped, superelastic, or other nitinol) or any other suitable substance.

Broaching member 3502 may be a substantially continuous structure. Broaching member 3502 may pass through a channel 3512 located in distal interface 3504. Broaching member 3502 may be secured to distal interface 3504 in channel 3512.

Broaching member 3502 may be supported by distal interface 3504. Broaching member 3502 may be supported by proximal interface 3506. The proximal interface 3506 may be supported by a broach sheath 3508. Broach sheath 3508 may have one or more structures in common with broach sheath 127 (shown in fig. 1) or any other broach sheath shown or described herein.

Drive shaft 3510 may rotatably drive broaching head 3500. The drive shaft 3510 may extend distally to the distal interface 3504. The drive shaft 3510 may extend to a proximal rotational source (not shown).

One or both of the distal interface 3504 and the proximal interface 3506 may be axially fixed to the drive shaft 3510. One or both of the distal interface 3504 and the proximal interface 3506 may be rotatably fixed to the drive shaft 3510.

The distal interface 3504 may be constructed of metal, stainless steel, laser cut tube, polymer, ceramic, or any other suitable material.

The distal end of the drive shaft 3510 may extend into a channel (not shown) located in the distal interface 3504. The distal interface 3504 may be free to move axially with respect to the drive shaft 3510. The channel in the distal interface 3504 may be keyed for receiving a complementary keyed distal end of the drive shaft 3510. Drive shaft 3510 may thereby drive distal portions 3518 and 3520 of broaching member 3502.

During rotation, broaching member 3502 may be along axis L_GAxially elongate and push the distal interface 3504 distally relative to the drive shaft 3510. This movement may cause broaching member 3502 to retract. During rotation, broaching member 3502 may be along axis L_GExpands axially and pulls the distal interface 3504 proximally relative to the drive shaft 3510. For example, when the distal interface 3504 encounters a resistant material, contraction may occur.

The distal interface 3504 may be secured to the drive shaft 3510. Broaching member 3502 may be rotatably driven by applying torque to proximal ends 3514 and 3516 of broaching member 3502. Broaching member 3502 may be rotatably driven by applying a torque to distal portions 3518 and 3520 of broaching member 3502.

Proximal ends 3514 and 3516 of broaching member 3502 may be attached to drive shaft 3510 by proximal interface 3506. The proximal interface 3506 can be engaged with the proximal end portions 3514 and 3516 by crimping, welding, set screws, snap fit, or any other suitable fastener.

The proximal interface 3506 may include or rotate about a bearing (not shown). The bearing may be disposed in the distal end of broach sheath 3508. Thus, as broaching member 3502 is rotated by drive shaft 3510, broach sheath 3508 and the bearings do not rotate. The orientation in which proximal ends 3514 and 3516 of broaching member 3502 are secured to proximal hub 3506 may provide or maintain the shape of broaching member 3502.

Distal interface 3504 may extend a distance E in a distal direction away from distal portions 3518 and 3520 of broaching member 3502. The distal interface 3504 may thus contact bone material in bone B (shown in fig. 2) before the distal end portions 3518 and 3520 come into contact with the material. If the material is high density, such as cortical bone, the material may resist distal advancement of the distal interface 3504. Broaching member 3502 is thereby prevented from broaching or interacting with the material.

The distal interface 3504 may include grooves 3522 and 3524. Broach edges 3526, 3528, 3530, 3532, 3534, and 3536 may displace material of the medial side of bone B. The grooves 3522 and 3524 may interact with each other at the distal end of the distal interface 3504.

The distal interface 3504 may have a blunt distal end without grooves. This may prevent broaching member 3502 from interacting with material resisting distal advancement of distal interface 3504. The distal end of the distal interface 3504 may be any suitable shape.

Distal interface 3504 may be devoid of broaching head 3500.

Fig. 36 shows an exemplary broach 3600. Broach 3600 may include a broach head 3602, a control shaft assembly 3604, and an actuator 3606.

The broaching head 3602 may include gang blades 3608, 3610, 3612, and 3613. Interlocking blades 3608 and 3610 may have broaching edges 3630 and 3632, respectively. When the broach head 3602 rotates around the axis L_IUpon rotation, the broaching edge may broach bone inside bone B (shown in fig. 2).

The blade may be radially positioned by a locking mechanism. The blade may be radially positioned by a resilient mechanism such that the blade may interact with bone tissue with sufficient pressure to displace bone tissue of a particular density, but with insufficient pressure to substantially not displace bone of a higher density.

Linkage blades 3608, 3610, 3612, and 3613 may be connected by one or more linkage members, such as linkage members 3614, 3616, 3618, and 3620. Linkages 3618 (and corresponding linkages 3619 (not shown)) may be supported by elongated members such as stationary posts 3622 and 3624. Stationary posts 3622 and 3624 may be about axis L_IAnd (4) fixing. Stationary posts 3622 and 3624 may be engaged by distal tip 3634.

The linkage 3614 may be supported by one or more elongated members such as strut posts (not shown) that extend axially within the control shaft assembly 3604. The lanyard post may cause radial extension and retraction of the blades by changing the axial distance between (a) linkage 3614 and (b) linkages 3618 and 3619 (not shown).

Control shaft assembly 3604 may include stationary struts 3622 and 3624, the one or more strut struts (not shown), housing members 3626 and 3628, one or more filler members (not shown), and other suitable members (not shown).

The actuator 3606 may include an element for creating deflection between an elongate member, such as a fixed strut and a lanyard strut. Actuator 3606 may include a mechanism for rotating broaching head 3602 about axis L_IA rotating element.

Fig. 37 shows the broach head 3602 and a portion of the control shaft assembly 3604 with the housing members 3626 and 3628 removed. Pullers 3702 and 3704 can be positioned in control shaft assembly 3604 to move linkage 3614 axially relative to linkages 3618 and 3619.

Fig. 38 illustrates an exemplary portion 3800 of linkage 3614. Portion 3800 may be a pin channel that spans the strut 3702 and 3704 and blades 3608 and 3610. A pin (not shown) may traverse the pin channel to reach the axially aligned holes 3802, 3804, 3808, and 3810 of the strut pull 3702, strut 3704, blade 3608, and blade 3610, respectively.

Fig. 39 shows pin channel 3902 of linkage 3618 and pin channel 3904 of linkage 3619. Pin channel 3902 traverses blade 3612, housing member 3622, and pin fastener 3906. Pin channel 3904 traverses blade 3613, housing member 3624, and pin fastener 3908.

A pin (not shown) may be disposed in channel 3902 to axially secure linkage 3618 to housing member 3622. A pin (not shown) may be disposed in channel 3904 to axially secure linkage 3619 to housing member 3624. Linkage systemPieces 3619 and 3618 may be offset from axial LI by an amount Δ₃And Δ₄And (4) deflecting.

When broach head 3602 is in bone B along omega_IOr-omega_IWhen the direction is rotated and blades 3608 and 3610 are positioned as shown, broach edges 3630 and 3632 (shown in FIG. 36) will sweep out radius R_IMAXIs the maximum radius for the broach head 3602. If linkage 3614 (shown in FIG. 36) is moved from the axial position shown, broaching edges 3630 and 3632 will sweep R_IThe space of (a).

Fig. 40 illustrates the radial extent of the tip 4002 of the blade 3610 for different axial positions of the link 3614. When linkage 3614 is in the proximal-most position, tip 4002 may be located at R_I=R_I0To (3). At R_I0The broaching edge 3622 may be disengaged from the bone B (shown in fig. 2). When linkage 3614 is in a centered axial position, tip 4002 may be located at R_I=R_I1To (3). At R_I1Broaching edge 3622 may engage bone B. At R_I=R_IMAXBroaching edge 3622 may be spaced from axis L_IIs engaged with bone B at the maximum radius.

A filler member, such as filler 4004, may be placed in the space between the brace struts. The filler member may be disposed proximate to the blade actuated by the lanyard post. The filler member may provide lateral stability to the strut.

Fig. 41 illustrates an exemplary broaching head 4100. Broaching head 4100 may include broaching member 4102. Each of broaching members 4102 may have one or more features in common with broaching member 704 (shown in fig. 7) or any other broaching member shown or described herein. For example, the broaching head 4100 may have one broaching member, 2-6 broaching members, 7-20 broaching members, more than 20 broaching members, or any suitable number of broaching members.

Pulling head 4100 can be retracted toward drive shaft 4110 and into a broach sheath (not shown). The broach sheath may be inserted into an aperture such as H (shown in fig. 2). Broaching head 4100 may then be deployed by retracting the broach sheath. Broaching member 4102 may be sufficiently resilient to contract and may expand away from drive shaft 4110 as the broach sheath is retracted.

Broaching member 4102 may include a free distal end portion, such as distal end portion 4104. Broaching members having free distal ends may be supported at their proximal ends in the vicinity of the central axis of the broaching head 4100.

The distal end 4104 can have any suitable shape, such as pointed, bifurcated, rounded, blunt, or truncated.

Broaching member 4102 may be supported proximally by one or more of drive shaft 4110, a proximal hub (not shown), and a broach sheath. The broach sheath may have one or more structures in common with broach sheath 127 (shown in fig. 1).

Drive shaft 4110 may rotationally drive broaching head 4100. The rotation may be in the direction omega_S. The rotation may be in the direction-omega_S. Drive shaft 4110 may extend through a broach sheath (not shown) to reach a proximal rotation source (not shown).

Broaching member 4102 may be rotated at high angular velocity to fragment cancellous bone, such as bone B_CA(shown in FIG. 2). One or both of the stiffness and angular velocity of broaching member 4102 may be selected to select a bone density threshold above which broaching member 4102 will have reduced or substantially no effect, and below which broaching member 4102 will fragment cancellous bone.

One or more of broaching members 4102 may include a helical section, such as 4106. The segment 4106 may be supported by one or more reinforcements, such as 4108.

The section 4106 may be rigid. The section 4106 may be elastic. The section 4106 may have any suitable pre-set curvature. The section 4106 may include a substantially linear portion (not shown).

The section 4106 may include a length of wire, ribbon, cable, strand, or any other suitable form or structure. Sections 4106 may include polymers, metals, alloys, or any other suitable materials. Section 4106 may be constructed from a mesh cut from a metal tube.

The reinforcement 4108 may be a tube. Reinforcement 4108 may be made of a polymer, metal, alloy, or any other suitable material. One or more reinforcements, such as 4108, may be sized and positioned to support section 4106 with a desired profile. One or more enhancements, such as 4108, may provide bone broach abrasiveness, dynamic forces, or both.

The reinforcement 4108 may be a stent.

The helical section 4112 may "spiral" in the same direction as the helical section 4106. The helical section 4112 may be "helical" in a direction opposite to the helical section 4106, such that the distal tips 4104 and 4114 "face" the opposite circumferential direction.

Broaching member 4102 may be devoid of broaching head 4100. A reinforcement portion, such as 4108, may be positioned in broaching head 4100 as a broaching member.

Fig. 42 shows an exemplary intramedullary tool 4200. Tool 4200 may include a handle 4202, an elongated support 4204, and a probe 4206.

The practitioner can use the handle 4202 to insert the probe 4206 into the intramedullary space IS of the bone B (shown in fig. 2). Probe 4206 can be used to determine cancellous bone B_CA(shown in fig. 2). Probe 4206 can be used to treat bone fragments such as fragment p_hAnd p_a(shown in FIG. 2) applying force to locate the bone fracture for temporary reduction of the fracture, e.g., F_hAnd F_a(shown in FIG. 2). The probe 4206 may be viewed in situ during operation of the tool 4200 via fluoroscopic imaging or any other suitable type of imaging modality.

Probe 4206 may include a distal face 4208. Distal surface 4208 may be circular, tapered, faceted, or any other suitable shape. Probe 4206 may include a wire loop.

Probe 4206 may include a polymer, alloy, or any other suitable material.

Elongated support 4204 may include one or more linear portions, such as portion 4208. Elongate support 4204 may include one or more curved portions such as portions 4210. Elongated support 4204 may be shaped such that probe 4206 may be inserted into an angled recess, such as H or I (shown in fig. 2) and advanced substantially along bone axis LB toward distal end D of bone B (shown in fig. 2).

Elongated support 4204 may include one or more rigid sections. Elongated support 4204 may include one or more flexible segments. The flexible section may help probe 4206 successfully complete rotation from the angular aperture into the intramedullary space. The flexible section may help to keep probe 4206 substantially along bone axis L_BThe advancement (shown in fig. 2) deflects away from high density bone, such as high density cancellous or cortical bone.

Elongated support 4204 may have one or more solid portions. Elongated support 4204 may have one or more hollow portions.

Elongated support 4204 may comprise a polymer, alloy, or any other suitable material.

Thus, devices and methods for fracture repair have been provided. One skilled in the art will appreciate that the present invention can be practiced by other than the described embodiments, which are presented for purposes of illustration rather than of limitation. The invention is limited only by the following claims.

Claims (4)

1. An apparatus for positioning a device relative to an external structure of a bone, the device having a portion configured to be positioned in a target region inboard of the bone, the bone having a surface, a surface normal axis, an anterior-posterior axis, and a proximal-distal axis, the device comprising:

a bottom mark providing alignment relative to the surface normal axis and including a structure protruding from a bottom surface of the bottom mark;

a first lateral extension configured to correspond to an anterior profile of the bone and a second lateral extension configured to correspond to a posterior profile of the bone, the first and second lateral extensions providing alignment relative to the anterior-posterior axis; and

a frontal marking having a distal end configured to provide visual alignment along the proximal-distal axis.

2. A surgical instrument guide for guiding a surgical instrument relative to a bone, the surgical instrument guide comprising a set of members that operate outside of the bone to position the surgical instrument at a location that is inside of the bone, wherein the set of members comprises:

a positioning member that positions the guide on the bone for displacement along a surface normal axis of the bone, an anterior-posterior axis of the bone, and a proximal-distal axis of the bone, and for rotation about the surface normal axis of the bone, the anterior-posterior axis of the bone, and the proximal-distal axis of the bone; and

a control member that retains the guide for displacement along and rotation about the surface normal axis of the bone, the anterior-posterior axis of the bone, and the proximal-distal axis of the bone.

3. An apparatus for guiding an instrument relative to an elongated bone having a longitudinal axis, the apparatus comprising:

an implement guide member; and

a base member supporting the guide member; wherein the instrument guide member is configured to pivot relative to the base from a first position defining a first angle relative to the longitudinal axis of the elongated bone to a second position defining a second angle relative to the longitudinal axis of the elongated bone.

4. The device of claim 3, further comprising an alignment guide that aligns the instrument guide member with a first target area located inside the elongated bone when the guide member is in the first position and with a second target area located inside the elongated bone when the guide member is in the second position.