Device and system for facilitating insertion of a bone treatment device - Patents.com

Abstract

The device includes an outer sleeve of flexible material forming a longitudinally extending outer conduit therethrough for inserting a bone treatment device (BTD) into a target site within a living body. The distal opening of the outer conduit is open, and when the outer sleeve is at a desired location within the body, the BTD is inserted through the outer conduit and exits the outer sleeve near the target portion of the bone. The device also includes an inner sleeve received within the outer sleeve and defining an inner conduit within the outer sleeve to form a protective covering. The inner sleeve is split longitudinally. Portions on either side of the split of the inner sleeve are connected to each other to adjust the diameter of the inner conduit in response to force applied by one of the BTD and tissue surrounding the outer sleeve.

Description

[Technical field]

[0001] The present disclosure relates generally to devices and systems for facilitating the insertion of bone repair devices into a living body, and more particularly to devices and systems for facilitating the insertion of an intramedullary nail into a bone (e.g., the tibia). [Background technology]

[0002] Procedures for inserting an intramedullary (IM) nail into the tibia can be performed using a suprapatellar approach, which often facilitates the treatment of proximal and distal tibia fractures while allowing high pressure to be applied to the knee joint during drilling and reaming of the entry path for the IM nail, as well as during insertion of the nail itself. Summary of the Invention [Means for solving the problem]

[0003] The present disclosure relates to a device for facilitating insertion of a bone treatment device into a living body, the device including an outer sleeve of flexible material forming an outer conduit extending longitudinally therethrough for inserting the bone treatment device to a target site within the body, the outer conduit having an open distal opening such that a bone treatment device inserted through the outer conduit exits the outer sleeve proximate a target portion of a bone when the outer sleeve is at a desired location within the body.

[0004] The device also includes an inner sleeve received within the outer sleeve and defining an inner conduit within the outer conduit. The inner sleeve forms a protective covering within the outer conduit. The inner sleeve is formed of metal. The inner sleeve is split longitudinally. Portions of the inner sleeve split are coupled to each other such that a diameter of the inner conduit can be adjusted within a predetermined range in response to a force applied by one of the bone treatment device and tissue surrounding the outer sleeve.

[0005] An embodiment of the present application further relates to a system for treating a bone, the system including an insertion device configured for insertion into a living body, the insertion device providing a conduit to a target site within the body. The insertion device includes an outer sleeve of a flexible material forming an outer lumen extending longitudinally therethrough. A distal opening of the outer lumen is open such that a bone treatment device inserted through the outer lumen exits the outer sleeve near a target portion of the bone when the outer sleeve is at a desired location within the body. An inner sleeve is received within the outer sleeve and defines an inner lumen within the outer lumen. The inner sleeve forms a protective covering within the outer lumen. The inner sleeve is formed of a metal. The inner sleeve is split longitudinally. Both sides of the split of the inner sleeve are connected to each other to adjust the diameter of the inner lumen within a predetermined range in response to a force applied by one of an item inserted through the conduit and tissue surrounding the outer sleeve.

[0006] The system also includes a wire guide sized and shaped for insertion through the conduit to the target site. The wire guide includes a first lumen extending along a central longitudinal axis of the wire guide. The first lumen is sized and shaped to slidably receive a guidewire therethrough. The wire guide includes a second lumen laterally offset from and parallel to the first lumen. The second lumen is sized and shaped to slidably receive a guidewire therethrough. [Brief description of the drawings]

[0007] [Figure 1] 1 is a perspective view of a device according to one embodiment in position adjacent to and within a leg. [Diagram 2] FIG. 2 is an exploded view of the device of FIG. 1. [Diagram 3] FIG. 2 shows a diagram of the knee joint anatomy and the device of FIG. 1 with a guide wire inserted into the tibia. [Figure 4]FIG. 2 is a view of the proximal end of a wire guide for use with the device of FIG. 1. [Diagram 5] 13 is a perspective view of a wire guide according to a further embodiment, including an increased diameter section and a reduced diameter section. [Figure 6] FIG. 2 is a perspective view of the assembly of FIG. 1 in use with a drill bit. [Figure 7] FIG. 2 is a perspective view of an IM nail being inserted into the tibia in conjunction with the device of FIG. 1; [Figure 8] FIG. 13 is a perspective view of a protection assembly according to a further embodiment. [Figure 9] FIG. 9 is a partial cross-sectional view of the assembly of FIG. 8. [Figure 10] FIG. 9 is a view of a core protector sleeve of the assembly of FIG. 8. [Figure 11] 11 is a perspective view of a sheet of material from which the core protector sleeve of FIG. 10 may be formed. [Figure 12] 12 is an end view of the sheet of FIG. 11 and the core protector sleeve of FIG. 10. [Figure 13] FIG. 13 is a perspective view of a protection assembly according to a further embodiment. [Figure 14] FIG. 14 is an end view of the protection assembly of FIG. 13. [Figure 15] FIG. 14 is a cross-sectional view of the protection assembly of FIG. 13. [Figure 16] 14 shows an inner protective sleeve for one embodiment of the assembly of FIG. 13. [Figure 17] FIG. 17 is a perspective view of a sheet of material from which the core protector sleeve of FIG. 16 may be formed. [Figure 18] 14 shows an inner protective sleeve of a further embodiment of the assembly of FIG. 13. [Figure 19] FIG. 19 is a perspective view of a sheet of material from which the core protector sleeve of FIG. 18 may be formed. [Figure 20] 20 shows two of the sheets of FIG. 19 positioned to be joined to form the core protector sleeve of FIG. 18. [Figure 21] FIG. 13 is a side view of an inner protective sleeve according to a further embodiment. [Figure 22]FIG. 22 is a cross-sectional view of the inner protective sleeve of FIG. 21. [Figure 23] 22 is a cross-sectional view of the inner protective sleeve of FIG. 21 received within an outer sleeve. [Figure 24] FIG. 13 is a perspective view of a protection assembly according to a further embodiment. [Diagram 25] FIG. 2 is a side view of a trocar according to one embodiment. [Figure 26] FIG. 13 is a perspective view of a wire guidance portion according to a further embodiment. [Figure 27] FIG. 33 is a side view of a sheet of material from which the core protector sleeve of FIGS. 30-32 may be formed. [Figure 28A] 33 is a front view of the sheet of FIG. 27 bent into a preshape to form the core protector sleeve of FIGS. 30-32. FIG. [Figure 28B] 33 is a side view of the sheet of FIG. 27 bent into a preshape to form the core protector sleeve of FIGS. 30-32. FIG. [Figure 29] 33 is a bottom view of the sheet of FIG. 27 bent into a pre-shape to form the core protector sleeve of FIGS. 30-32. FIG. [Diagram 30] FIG. 28 is a side view of a core protector sleeve formed from the sheet shown in FIG. 27. [Diagram 31] FIG. 28 is a front view of a core protector sleeve formed from the sheet shown in FIG. 27. [Diagram 32] FIG. 28 is a perspective view of a core protector sleeve formed from the sheet shown in FIG. 27. [Figure 33A] 1 is a perspective view of a handle of a protection assembly according to one embodiment, the handle halves being separated from each other; FIG. [Figure 33B] FIG. 33B is a top view of one half of the handle of FIG. 33A. [Diagram 34] FIG. 33B is a cross-sectional view of the guidewire opening of the handle of FIG. 33A. [Diagram 35] FIG. 33B is a side view of a locking ring for use with the handle of FIG. 33A. [Diagram 36] FIG. 36 is a perspective view of the locking ring of FIG. 35. [Figure 37]36 shows an outer sleeve for use with one embodiment of a protection assembly including the handle of FIG. 33A and the locking ring of FIG. 35. [Figure 38] FIG. 1 is a perspective view of a fixed guidewire according to one embodiment. [Figure 39] 39 is a top view of the protection assembly of FIG. 13 and the fixed guidewire of FIG. 38. [Diagram 40] 39 is a side view of the protection assembly of FIG. 13 and the fixed guidewire of FIG. 38. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0008] The present disclosure may be further understood with reference to the following description and the accompanying drawings, in which like elements are referred to with the same reference numerals. Exemplary embodiments describe devices and procedures for suprapatellar insertion of a tibial IM nail. As used herein, the terms distal and proximal refer to directions away from the groin to the body (distal) and toward the groin to the body (proximal). Although the embodiments described herein are specifically configured for procedures for suprapatellar insertion of a tibial IM nail, one skilled in the art will understand that the embodiments described herein may also be employed in procedures relating to spinal surgery.

[0009] As will be appreciated by those skilled in the art, fractures of the tibia may be treated by the insertion of an IM nail, and in certain cases, the IM nail is inserted in a suprapatellar approach. In these cases, instruments such as drills and reamers, as well as the IM nail itself, are inserted into the proximal end of the tibia through the space between the patella and the femur. This procedure requires displacement of the patella and may put pressure on the patella, its supporting anatomical structures, and the surrounding tissue. Generally, a protective sleeve is inserted through this space to protect the surrounding tissue from damage that may otherwise cause the instruments or the nail itself to contact the surrounding tissue. The tissue surrounding this space is displaced and is subject to significant stress throughout the time that the protective sleeve remains in this position. The embodiments of the present application provide protection of the surrounding tissue while reducing the stress applied to this tissue during the procedure. Generally, such procedures include reducing the fracture (using any known technique) and then determining the length and diameter of the IM nail, also using any known technique. An incision is then made and the entry site for the IM nail is determined. Additionally, techniques such as blunt dissection may be employed to loosen the patella so that it can be moved away from the femur.

[0010] As seen in Figures 1 and 2, a protective sleeve assembly 212 may be used, as described in more detail below with respect to Figure 13. The trocar 22 is then inserted through the protective sleeve assembly 212, and the combination is inserted at an entry site such that the IM nail enters the body through an incision and passes through the knee joint to the proximal end of the tibia 28, for example, between the articular surface of the patella 24 and the distal femur 26. The protective sleeve assembly 212 is then secured in place to either the tibia or femur through the placement of a guidewire, as described in more detail below.

[0011] As seen in Figures 38-40, tibial fixation may be performed using a fixation guidewire 100. The fixation guidewire 100 extends from a proximal end 103 to a distal end 105 and includes a shoulder or stop 102, e.g., welded to the fixation guidewire 100, and a threaded tip 104 at the distal end 105. The stop 102 is sized and shaped to prevent the fixation guidewire 100 from being threaded through the protective sleeve assembly 212 more than a desired depth. The stop 102 is positioned such that when the fixation guidewire 100 is inserted into the tibia as desired, contact between the stop 102 and the protective assembly sleeve 212 holds the protective sleeve assembly 212 in a desired position relative to the tibia.

[0012] As described below, the protective sleeve assembly 212 includes an inner sleeve formed of a metal, such as stainless steel, and an outer sleeve formed of a yielding material, such as, for example, a flexible plastic. Thus, the inner metal sleeve protects the outer plastic sleeve from damage that might otherwise occur to the softer plastic material during drilling, reaming, etc. The device is inserted until the trocar 22 reaches the surface of the tibia 28 at the entry site B, e.g., the anterior surface of the proximal tibia.

[0013] At this point, the trocar 22 is removed and the wire guide 30 is inserted through the protective sleeve assembly 212 to guide the placement of the first guide wire 32 through the entry site along the desired path drilled for insertion of the IM nail into the medullary canal of the tibia 28, as shown in Figures 3 and 4. Those skilled in the art will appreciate that any known technique may be used to insert the guide wire 32 as desired. In this case, the guide wire 32 is placed in the tibia 28 by the wire guide 30 which is inserted through the protective sleeve assembly 212 to the entry site. The guide wire 32 is threaded through a central lumen 34 which extends along the longitudinal axis of the wire guide 30 (which in this embodiment coincides with the central axis of the protective sleeve assembly 212) and enters the tibia 28 along a path parallel to and defined by the path of the central lumen 34 of the wire guide 30. The positioning of the guide wire 32 may then be checked and adjusted using the wire guide 30 as follows:

[0014] After checking the position of the guidewire 32, if it is determined that the position of the guidewire 32 should be adjusted, the physician removes the wire guide 30 by withdrawing it over the guidewire 32 until it exits the wire guide 30, and then reinserts the guidewire 32 into the offset lumen 36 that is radially offset from and parallel to the central lumen 34. The wire guide 30 is then threaded over the guidewire 32 through the protective sleeve assembly 212 to the proximal surface of the tibia, and rotated as desired until the central lumen 34 is aligned with the desired path along which the second guidewire 32 is desired to be inserted into the tibia 28. The second guidewire 32 is then positioned as desired, and the first guidewire 32 is removed. In addition, as shown in FIG. 5, the outer diameter of a wire guide 30' according to a further embodiment varies along its length such that the protective sleeve assembly 212 can be partially radially collapsed when the wire guide 30' is received therein. Specifically, the outer diameter of the wire guide 30' includes a distal portion 31 at its distal end that contacts the tibia when the wire guide 30' is fully inserted, the outer diameter of which substantially corresponds to the inner diameter of the protective sleeve assembly 212, and a proximal portion 31' that is received in the proximal end of the protective sleeve assembly 212 separated by a central reduced diameter portion 33 when the wire guide 30' is fully inserted.

[0015] This ensures that the wire guide 30' is properly centered in the protective sleeve assembly 212 while allowing a central portion of the protective sleeve assembly 212 to partially radially collapse, reducing pressure applied to surrounding tissue as described in more detail below. As shown in FIG. 6, a drill bit 38 is then advanced over the guidewire 32 (second guidewire) and through the protective sleeve assembly 212 to the entry site, at which point the physician drills an entry hole into the medullary canal, as will be understood by those skilled in the art. The physician can then remove the drill bit and, if desired, advance a reamer over the guidewire 32 (or reaming rod, i.e., a 2.5-3 mm long flexible steel rod) to ream the drilled opening and / or the medullary canal, as will be understood by those skilled in the art.

[0016] Once the approach pathway and medullary canal are prepared, as shown in FIG. 7, the reamer may be removed and the IM nail 40 is ready for insertion. As will be appreciated by those skilled in the art, the proximal end of the IM nail 40 may be coupled to an insertion handle 42 and the distal end of the IM nail 40 is inserted through the protective sleeve assembly 212 to the approach pathway. During the time between the completion of the approach pathway / medullary canal preparation and the time the IM nail 40 is ready for insertion, the protective sleeve assembly 212 partially collapses radially inward to relax the surrounding tissue and allow the bit to reduce the trauma associated with its displacement. This again reduces the time that the tissue in the suprapatellar space is subjected to high levels of stress. The IM nail 40 can then be inserted into the tibia 28 and locked into place using any known technique.

[0017] As shown in Figures 8-12, a further embodiment of a protective sleeve assembly 112 for use in inserting an IM nail 40 via a suprapatellar approach, for example, can be used with a separate handle. Specifically, the sleeve 112 includes a soft outer protective sleeve 114 extending from a proximal base 115 that connects to a handle in a known manner. The outer sleeve 114 surrounds a metallic inner core sleeve 116 that protects the outer sleeve 114 from damage from drill reamers or the like inserted through the assembly 112. The core sleeve 116 includes a radial flange 118 that mates with corresponding structure on the outer sleeve 114 to maintain the core sleeve 116 in a desired position within the outer sleeve 114.

[0018] Additionally, the radial flanges 118 make the proximal and distal ends of the core sleeve 116 substantially incompressible, making it easier to pull an item inserted distally beyond the assembly 112 back into the assembly 112 by ensuring that the diameter of the distal end of the core sleeve 116 remains sufficient to receive the item. The core sleeve 116 is structured to allow the core sleeve 116 to deflect radially inward upon being subjected to a compressive force (e.g., a force exerted by surrounding tissue) when its lumen 120 is not occupied by an incompressible item (e.g., an IM nail, drill, reamer, etc.).

[0019] As shown in Figures 11 and 12, the core sleeve 116 of this embodiment may be formed from a sheet of metal 121. The sheet may be formed from any suitable material, such as any hardened spring steel wrapped around a longitudinal axis L to form a cylinder and bent on a bending axis B to form a radial flange 118. The sheet 121 includes a series of longitudinal voids 124 that improve the flexibility of the core sleeve 116, thereby allowing the assembly 112 to collapse radially inwardly when an instrument is not passing through the sleeve assembly 112 (or when the outer diameter of an item received within the assembly 112 is smaller than the inner diameter of the core sleeve 116), reducing trauma to the tissue surrounding the assembly 112. Additionally, the outer sleeve 114 of this embodiment includes two guidewire lumens 126 that extend on either side of the lumen 120. In this embodiment, guidewire lumen 126 runs parallel to lumen 120, although guidewire lumen 126 may run in a different direction relative to lumen 120. As will be appreciated by those skilled in the art, guidewire lumen 126 may be used to secure assembly 112 in a desired location on the tibia by inserting a guidewire into the proximal end of the tibia. In another embodiment, core sleeve 116 may be formed from a tube of any suitable material, the tube having a longitudinal void similar to longitudinal void 124.

[0020] 13-15 show yet another embodiment of a protective sleeve assembly 212 extending from a handle 213 at its proximal end to a distal end 215 shaped to rest substantially flush against a target portion of a bone. An outer sleeve 214 surrounds a metal inner core sleeve 216 which protects the outer sleeve 214 from damage from drill reamers and the like inserted through the assembly 212. The distal end 215 is preferably more rigid than the rest of the device so that it remains fully open, and the distal end 215 includes a chamfer 217 which facilitates pulling back into the assembly 212 an item (e.g., a reamer) inserted distally beyond the assembly 212 by ensuring that the diameter of the distal end of the assembly 212 remains sufficient to receive the item. The core sleeve 216 is structured to allow the core sleeve 216 to deflect radially inward when subjected to a compressive force (e.g., a force exerted by surrounding tissue) when its lumen 220 is not occupied by a non-compressible item (e.g., an IM nail, drill, reamer, etc.).

[0021] 13, the handle 213 also includes two guidewire insertion openings 219 configured to allow for the insertion of guidewires into the femur to secure the assembly 212 to the femur if desired, as an alternative to, or in addition to, securing the assembly 212 to the tibia. The openings 219 are formed as substantially conical openings to allow for angling the guidewires relative to the handle 213 at any desired orientation within an angular tolerance. For example, the openings 219 may allow for the insertion of a guide at any angle within a cone having an apex angle of 55 degrees.

[0022] As shown in Figures 16-20, the core sleeve 216 of this embodiment may be formed from one or more sheets 222 of metal or other material similar to that described above with respect to the core sleeve 116. As seen in Figures 16 and 17, the core sleeve 216' is formed by wrapping a single sheet 222' about a longitudinal axis L= to form a generally oval structure having longitudinal openings 224 on either side thereof. The ends of the wrapped sheet 222' may then be welded to form an oval tubular structure.

[0023] As seen in FIG. 17, the sheet 222 includes a series of transverse slits 226 on its outer edge. The longitudinal openings 224 formed as slots on either side of the core sleeve 216′ are formed by bending radially outward fins 228 formed between adjacent ones of the slits 226. The resulting structure of the core sleeve 216′ fits into a correspondingly shaped interior space of the outer sleeve 214, as shown in FIG. 15. In another embodiment, the longitudinal openings 224 may be shaped along any curve, for example a helical curve. In another embodiment, the core sleeve 216 may be formed from a tube of material as described above with respect to the core sleeve 116, the tube having longitudinal openings similar to the longitudinal voids 224 and transverse slits similar to the transverse slits 226.

[0024] The sheet 222' also includes a longitudinal slit 228 with a series of transverse slits 230 intersecting the slits 228 at regularly spaced intervals. The core sleeve 216 is shaped and structured to enhance the compressibility of the assembly 212 in directions transverse to the axis L, and in particular in directions transverse to the width of the slot 224. The assembly 212 is constructed to have the greatest deflection in the direction of the greatest compressive force exerted by the surrounding tissue. That is, for this device, the assembly 212 is designed to compress more easily in the anterior-posterior direction because that is the direction of the greatest force exerted on the assembly 212 by the surrounding tissue.

[0025] As will be appreciated by those skilled in the art, the width of the longitudinal opening 224 (the extent of the opening 224 in a direction transverse to the longitudinal axis of the assembly 212) defines the maximum deflection of the core sleeve 216 and, therefore, the assembly 212. That is, when deflected to a maximum extent, the opposing sides of the longitudinal opening 224 contact each other. As discussed above, when an instrument is not passing through the sleeve assembly 212 (or when the outer diameter of an item received within the assembly 212 is smaller than the inner diameter of the core sleeve 216), the assembly 212 collapses radially inward to reduce trauma to the tissue surrounding the assembly 212. Additionally, the outer sleeve 214 in this embodiment includes two guidewire lumens 232 that extend parallel to and on either side of the lumen 220.

[0026] As seen in Figures 18-20, the inner core protection sleeve 216" may be formed from two sheets 222", each pressed into a substantially symmetrical shape and welded together at the edges of the sheets. In contrast to the sleeve 216', the sleeve 216" does not include lateral slots 224. Rather, the fins 226' of the sheets 222" are bent to extend laterally away from the central axis L@ of the sleeve 216" so as to group together to form wings 225 on either side of the sleeve 216". As with the openings 224, the width of the wings 225 defines the maximum deflection of the core sleeve 216" and, therefore, of the assembly mounted therein; that is, when deflected to a maximum amount, the opposing sides of the wings 225 contact each other.

[0027] A core protective sleeve 312 included in any of the protective sleeve assemblies described herein is shown in Figures 21-23. The sleeve 312 is configured to be inserted into any of the outer sleeves described herein to form a durable protective sleeve assembly that resists damage during drilling and reaming. In this embodiment, the core protective sleeve 312 includes a proximal portion 314 having a first diameter and a distal portion 316 having a second diameter larger than the first diameter. The increased diameter distal portion 316 is sized to center the sleeve 312 at the distal end of the protective sleeve assembly to properly orient the operating head 318 of a reamer or drill bit 320, while the reduced diameter proximal portion 314 is sized to receive the drive shaft 322 of the reamer or drill bit 320 with clearance to allow the protective sleeve assembly to partially collapse.

[0028] As will be appreciated by those skilled in the art, the inner diameters of the proximal and distal portions 314, 316 are sized to allow sufficient clearance for the portion of the reamer or drill bit 320 housed therein such that the reamer or drill bit 320 may rotate freely within the core protection sleeve 312. Thus, only the portion of the protection sleeve 312 that houses the distal portion 316 of the core protection sleeve 312 is prevented from radially collapsing to reduce tissue stress. Thus, when the core protection sleeve 312 is used, a large portion of the length of the protection sleeve 312 is not compressed and reduces stress to the surrounding tissue. As shown in FIG. 23, the clearance between the outer diameters of the proximal portion 316 extends from the proximal end of the distal portion 314 to the proximal end of the protection sleeve 312, allowing partial radial collapse of the protection sleeve 312 along this entire portion. As will be appreciated, the core protection sleeve 312 may only be used with devices having a reduced diameter shaft extending along a significant portion of its length.

[0029] As shown in FIG. 24, a further embodiment of the protective sleeve assembly 412 is substantially similar to the protective sleeve assembly 212 described above, except that the assembly 412 does not include any guidewire lumen, thereby providing a reduced profile and further reducing trauma to the surrounding tissue. That is, the protective sleeve assembly 412 may be selected by a user who does not wish to insert a guidewire into the tibia to secure the assembly 412 in a desired position. In this case, the assembly 412 is secured only by a guidewire inserted through a guidewire opening 419 in the handle 413. As seen in FIG. 24, the protective sleeve assembly 412 extends from the handle 413 at its proximal end to a distal end 415 shaped to rest substantially flush against the target portion of the bone.

[0030] The outer sleeve 414 surrounds a metallic inner core sleeve 416 that protects the outer sleeve 414 from damage from drills, reamers, and the like inserted through the assembly 412. The core sleeve 416 may be constructed according to any of the embodiments described herein. The stiffness of the distal end 415 is preferably greater than the rest of the device so that it remains fully open, and the distal end 415 includes a chamfer 417 that facilitates pulling an item (e.g., a reamer) inserted distally beyond the assembly 412 back into the assembly 412 by ensuring that the diameter of the distal end of the assembly 412 remains sufficient to receive the item.

[0031] As noted above, the core sleeve 416 is structured to allow the core sleeve 416 to deflect radially inward upon being subjected to a compressive force (e.g., a force exerted by surrounding tissue) when its lumen is not occupied by a non-compressible item (e.g., an IM nail, drill, reamer, etc.). The handle 413 also includes two guidewire insertion openings 419 configured to allow for the insertion of guidewires into the femur to secure the assembly 412 to the femur. The openings 419 are formed as substantially conical openings to allow for angling of the guidewires relative to the handle 413 at any desired orientation within the angular tolerance.

[0032] 25 illustrates a trocar 430 for use with any of the protective sleeve assemblies described herein. Trocar 430 includes a blunt, tapered distal tip 432. Trocar 430 is sized such that when a handle 434 at its proximal end is seated within a correspondingly sized and shaped recess in the handle of the protective sleeve assembly (e.g., within recess 420 in handle 413 of assembly 412), distal tip 432 projects distally from sleeve 414 to provide a blunt dissection tip to facilitate insertion of the combined trocar 430 and assembly 412 over a guidewire to a target side adjacent the proximal end of the tibia.

[0033] The trocar 430 includes a reduced diameter proximal shaft 436 having a diameter smaller than that of the distal tip 432. The diameter of the distal tip 432 and the diameter of the proximal portion 438 in this embodiment substantially correspond to the inner diameter of the core sleeve 416 such that the trocar 430 is centered within the assembly 412. The trocar 430 also includes an optional locking structure 440 configured to snap engage with a corresponding structure within the recess 420 to retain the trocar 430 in a desired position within the assembly 412. As will be appreciated by those skilled in the art, a wire guide such as wire guide 30 can be used to reinforce the protective assembly during insertion and provide a tapered tip to facilitate blunt dissection as the protective sleeve assembly is inserted into a desired location adjacent the proximal end of the tibia.

[0034] As shown in FIG. 26, an alternative embodiment of the wire guide 450 includes a central lumen 452 (which in this embodiment coincides with the central axis of the protective sleeve 412 being inserted) that extends along the longitudinal axis of the wire guide 450. As described above, if it is determined that the position of the guidewire needs to be adjusted, the physician removes the wire guide 450 by withdrawing it over the guidewire until it exits the wire guide 450, and then reinserts the guidewire into an offset lumen 454 that is radially offset from and parallel to the central lumen 452. The wire guide 450 is then threaded over the guidewire and through the protective sleeve 412 to the proximal surface of the tibia, and optionally rotated until the central lumen 452 is aligned with the desired path along which a second guidewire is desired to be inserted into the tibia. A second guidewire is then optionally placed into the tibia via the central lumen 452, and the first guidewire is removed. As shown in FIG. 26, the distal portion 456 of the wire guide 450 is formed as a section of a cylinder having machined flat sides 458 .

[0035] In an alternative embodiment, the wire guide 450 is inserted directly into the tibia through the incision. A guidewire is inserted into the tibia through the wire guide 450 in a similar manner as described above, and the protective sleeve 412 is inserted directly over the guidewire without the use of a trocar. The protective sleeve 412 is then secured to either the tibia, the femur, or both. After securing the protective sleeve 412, the wire guide 450 is removed. In such an embodiment, the wire guide 450 is made as slim as possible, i.e., the distal portion of the wire guide 450 has a reduced diameter with a blunt tip and flattened sides.

[0036] The distal portion 456 in this embodiment is sized to be as small as possible while still accommodating the central lumen 452 and offset lumen 454. This allows the distal portion to partially collapse the protective sleeve assembly through which it is passed, further reducing trauma to the surrounding tissue. As will be appreciated by those skilled in the art, the length of the wire guide 450 is selected such that when the wire guide 450 is fully inserted into the protective sleeve assembly, the distal end 460 of the wire guide 450 contacts the tibia while the proximal end 462 extends proximally from the handle of the protective sleeve assembly into which it is inserted. As seen in FIG. 26, the distal end 460 of the wire guide 450 is alternatively formed as a rounded, concave end to facilitate blunt dissection of tissue so that the wire guide 450 can be used instead of the trocar 430 to facilitate insertion of the protective sleeve assembly over a guidewire to a target site at the proximal end of the tibia.

[0037] As shown in Figures 27-32, a further embodiment of a core sleeve 500 that may be employed in any of the protective sleeve assemblies described herein may be formed from two sheets 502 of metal or other material similar to that described above with respect to the core sleeve 116. As seen in Figures 27-32, the core sleeve 500 according to this embodiment is formed by bending a pair of sheets 502 about a longitudinal axis L, with each sheet 502 forming one half of a generally tubular structure, the two halves being mirror images of each other. Each sheet 502 includes a plurality of receiving tabs 504 each defining a tab receiving opening 508 along a first side, and has a corresponding plurality of locking tabs 506 formed at corresponding locations along the axis L on the opposing side.

[0038] Each of the locking tabs 506 of a first one of the sheets 502 is sized and positioned to be received through a tab receiving opening 508 of a correspondingly located receiving tab 504 of the other sheet 502 after the sheet 502 is bent into its semi-tubular shape. As seen in Figures 28A, 28B, and 29, after the sheet 502 of this embodiment is bent into its generally semi-tubular shape, the receiving tabs 504 extend generally along a tangent to the tube formed by the sheets 502, while the locking tabs 506 project radially outwardly away from the axis L. Thus, when the sheets 502 are assembled to form the generally tubular structure of the core sleeve 500, each locking tab 506 projects radially outwardly through the tab receiving opening 508 of its corresponding receiving tab 504.

[0039] In a subsequent movement, as shown in FIGS. 30-32, each locking tab 506 is then bent toward a position where the outer end of the locking tab 506 extends back toward its connection point to the sheet 502 from which it extends substantially parallel to the receiving tab 504 through which it extends. This locks the two sheets 502 together while allowing the tubular structure of the core sleeve formed by the sheets 502 to contract under pressure from the surrounding tissue in the same manner as described above with respect to the other core sleeves. The extent of this contraction C is defined by the dimension of the tab receiving opening 508 in a direction tangential to the tubular structure minus the thickness of the tab 506 (i.e., by the range of movement allowed for each of the tabs 506 within its corresponding tab receiving opening 508).

[0040] Additionally, the two sleeves 502 are connected together, for example, by welding at their distal ends 510, while the proximal ends 512 of the sheets 502 are not welded together. Specifically, the distal ends 510 of this embodiment are laser welded along seam 514. One skilled in the art will appreciate that this allows the tubular structure of the core sleeve according to this embodiment to be more expandable at its proximal end 512 when pushed through the bent portion of the IM nail.

[0041] Additionally, the connection between the locking tabs 506 and the receiving tabs 504 improves the resistance of the core sleeve according to this embodiment to shear forces that the protective sleeve experiences from the patella-femoral joint as the bent IM nail is forced through the protective sleeve. That is, as the bent IM nail is forced through the protective sleeve, one half of the core sleeve (e.g., along the inner diameter of the bend of the IM nail) may be biased to move proximally within the protective sleeve, while the other half of the core sleeve experiences a biasing force in the opposite direction. This, in this embodiment, sets up a shear force acting between the two sheets 502 that is resisted by contact between the locking tabs 506 and the distal faces 508′, 508″ of the proximal ends of each of the tab receiving openings 508, preventing movement of the sheets 502 relative to one another as the IM nail is inserted therethrough.

[0042] Further, the connection between the locking tabs 506 and the distal faces 508', 508" of the proximal ends of each of the tab receiving openings 508 prevents radial outward expansion of the core sleeve as the nail bends through it, minimizing pressure on the knee joint. Additionally, each of the seats 502 includes a tab 516 that functions to lock the core sleeve to the handle to prevent the core sleeve from moving distally within the protective sleeve as the IM nail is pushed distally through the protective sleeve, as described below.

[0043] 33-37, for example, a protective sleeve assembly 550 for use with core sleeve 500 includes an outer sleeve 560, a handle 580, and a locking ring 600 interconnecting the outer sleeve 560, the core sleeve 500, and the handle 580. As seen in FIG. 33, the handle 580 is formed of two halves interconnected to receive a mating platform 562 that projects laterally outwardly at a proximal end 564 of the sleeve 560. The mating platform 562 is received within a correspondingly sized and shaped cavity 582 formed between the halves of the handle 580. Additionally, after the core sleeve 500 is inserted into the outer sleeve 560, the locking ring 600 is seated within the proximal opening 564 and the mounting posts 602 of the locking ring 600 are received within the wells 566 on either side of the opening 564 until the distal surfaces 604 of each of the posts 602 rest on the proximally-facing surfaces at the distal ends of the wells 566.

[0044] When the locking ring 600 is inserted distally into the opening 564, the laterally projecting spurs 606 of the locking ring slide into the core sleeve 500 until each of the spurs 606 enters an opening under a corresponding one of the tabs 516 of the core sleeve 500, locking the core sleeve 500 in the desired position within the outer sleeve 560. In this embodiment, the outer sleeve 560 does not include a lateral guidewire lumen for tibial fixation. Thus, in this embodiment, the post 602 projects proximally from the outer sleeve 560 to engage an opening 584 in the handle 580, and in embodiments that include such tibial fixation guidewire lumens, opens these guidewire lumens through the handle 580. As will be appreciated by those skilled in the art, the outer sleeve 560 in this embodiment can be substantially similar to any of the outer sleeves described above, except that the structure at the proximal end serves to secure the outer sleeve 560 to the handle 580.

[0045] The locking ring 600 in this embodiment not only locks the core sleeve 500 in a desired position within the outer sleeve 560, but also functions to block the tibial fixation guidewire opening in the handle 580. Those skilled in the art will appreciate that if the outer sleeve includes a lateral guidewire for tibial fixation, the locking ring is constructed similarly to the locking ring 600, except that the post 602 is not included so as to not block the guidewire opening 584. As will be appreciated, the guidewire lumen of such an outer sleeve is positioned such that a guidewire inserted through any of the openings 584 in the handle 580 will pass through the handle 580 into the proximal opening of one of the lateral guidewire lumens and therethrough to the proximal aspect of the tibia in the same manner as described above.

[0046] When the halves of the handle 580 are mated together, the outer sleeve 560 snaps onto the mating platform 562 to lock onto the handle 580. As shown in FIGS. 33A and 34, the handle 580 includes two guidewire openings 586 oriented to allow for the insertion of a guidewire into the femur to stabilize the protective sleeve assembly 500. As shown in FIG. 34, each of the guidewire openings 586 is formed as a portion of a cone having an apex angle of 55 degrees (i.e., a guidewire can be inserted in any direction into any of the openings 586 at an angle of up to 27.5 degrees from the central axis CA of the opening 586. However, it will be understood by those skilled in the art that this angle α can be any desired value that allows for the desired femoral fixation. As mentioned above, the recess 588 at the proximal end of the handle 580 is sized, shaped and structured to receive and lock into place a trocar, as described above, or any other device inserted through the central lumen of the assembly 550.

[0047] Although these embodiments have been described in the context of suprapatellar insertion of a tibial IM nail, those skilled in the art will appreciate that the system is useful in spinal surgery as well. In addition, while specific embodiments and methods have been described, it will be understood that various modifications other than those described above may be made without departing from the spirit or scope of the invention as defined in the appended claims. For example, equivalent elements may be substituted for those specifically illustrated and described, certain features may be used independently of other features, and in certain cases, certain applications of elements may be reversed or interleaved, all without departing from the spirit or scope of the invention.

[0048] [Embodiment] (1) A device for facilitating insertion of a bone treatment device into a living body, comprising: an outer sleeve of flexible material forming an outer conduit extending longitudinally therethrough for inserting the bone treatment device to a target site within the body, the outer sleeve having an open distal opening such that when the outer sleeve is at a desired location within the body, the bone treatment device is inserted through the outer conduit and exits the outer sleeve adjacent a target portion of a bone; an inner sleeve received within the outer sleeve and defining an inner conduit within the outer conduit, the inner sleeve forming a protective covering within the outer conduit, the inner sleeve being formed of metal, the inner sleeve being split, with opposite sides of the split portion of the inner sleeve being connected to each other such that a diameter of the inner conduit can be adjusted within a predetermined range in response to a force applied by one of the bone treatment device and tissue surrounding the outer sleeve; A device comprising: (2) The device of embodiment 1, wherein the inner sleeve includes a first adjustment opening extending longitudinally along a portion of the length of the inner sleeve, and a width of the first adjustment opening transverse to the longitudinal axis of the inner sleeve defines a maximum reduction in the diameter of the inner conduit as the diameter when opposing sides of the first adjustment opening contact each other. (3) The device of claim 2, wherein the inner sleeve is formed of a first member and a second member, the first member including the first adjustment opening and a first sliding tab, and the second member including a second adjustment opening and a second sliding tab, the first and second adjustment openings and the first and second sliding tabs being sized and positioned such that when the first and second members are in a desired position relative to one another, the first sliding tab is slidably received within the first adjustment opening and the second sliding tab is slidably received in the second adjustment opening to couple the first and second members to one another, and the first and second sliding tabs are slidable within corresponding ones of the first and second adjustment openings transverse to the longitudinal axis of the first sleeve. (4) The device of embodiment 1, wherein the outer sleeve includes a first guidewire lumen extending longitudinally therealong, the first guidewire lumen being oriented such that, when the device is in a desired position, a guidewire inserted therethrough will enter a portion of bone adjacent the distal opening of the outer conduit to anchor the device in the desired position. (5) The device of embodiment 4, further comprising a handle attached to a proximal end of the outer sleeve, the handle including a second guidewire lumen extending therethrough, the second guidewire lumen oriented such that when the device is then at the desired location, a guidewire inserted through the second guidewire lumen enters a non-target bone and secures the device to the non-target bone at the desired location relative to the target portion of bone.

[0049] (6) A system for treating a bone, comprising: an insertion device configured for insertion into a living body, the insertion device providing a conduit to a target site within the body, the insertion device including: an outer sleeve of a flexible material forming an outer lumen extending longitudinally therethrough, a distal opening of the outer lumen being open such that when the outer sleeve is at a desired location within the body, a bone treatment device inserted through the outer lumen exits the outer sleeve near a target portion of the bone; and an inner sleeve received within the outer sleeve and defining an inner lumen within the outer lumen, the inner sleeve forming a protective covering within the outer lumen, the inner sleeve being formed of a metal, the inner sleeve being split longitudinally, portions on either side of the split of the inner sleeve being coupled to each other such that a diameter of the inner lumen can be adjusted within a predetermined range in response to a force applied by one of an item inserted through the conduit and tissue surrounding the outer sleeve; a wire guide sized and shaped for insertion through the conduit to the target site, the wire guide including a first lumen extending along a central longitudinal axis of the wire guide, the first lumen sized and shaped to slidably receive a guidewire therethrough, and a second lumen laterally offset from and parallel to the first lumen, the second lumen sized and shaped to slidably receive a guidewire therethrough; A system comprising: (7) The system of embodiment 6, wherein the outer sleeve includes a first guidewire lumen extending longitudinally along the outer sleeve laterally outside the conduit, the first guidewire lumen oriented such that when the insertion device is in the desired position, a guidewire inserted therethrough will enter a portion of bone adjacent the distal end of the conduit to anchor the insertion device in the desired position. (8) The system of embodiment 7, wherein the insertion device further comprises a handle attached to a proximal end of the outer sleeve, the handle including a second guidewire lumen extending therethrough, the second guidewire lumen oriented such that when the device is then in the desired location, a guidewire inserted through the second guidewire lumen enters a non-target bone and secures the device to the non-target bone at the desired location relative to the target portion of bone. (9) The system of embodiment 6, wherein the wire guide includes a first generally flat surface and a second generally flat surface connected to each other by an arcuate surface that mirrors the curvature of the inner lumen such that the wire guide is rotatable within the inner lumen, a thickness of the wire guide defined as the distance separating the generally flat surfaces is less than a diameter of the inner lumen, and when the wire guide is received within the lumen, a force applied to the outer sleeve by surrounding tissue compresses the outer sleeve and the inner sleeve toward the wire guide. (10) The system of embodiment 8, wherein the wire guide portion includes a distal end that is curved to form a blunt, rounded end to facilitate blunt dissection of tissue.

[0050] (11) The system of embodiment 6, further comprising a trocar sized and shaped for insertion through the conduit, the trocar including a distal end curved to form a blunt, rounded end to facilitate blunt dissection of tissue when the trocar is inserted into the insertion device such that the blunt, rounded end protrudes distally from the outer sleeve. (12) The system of claim 10, wherein the insertion device further includes an insertion device handle attached to a proximal end of the outer sleeve, the insertion device handle including a recess configured to lockingly receive a proximal handle of the trocar, and a length of the trocar is selected such that the blunt, rounded end of the trocar is in a desired position extending distally from the outer sleeve when the proximal handle of the trocar is lockingly received within the insertion device handle. 13. The system of embodiment 6, wherein the insertion device further includes an insertion device handle attached to a proximal end of the outer sleeve, the inner sleeve including a locking tab adjacent its proximal end, and the system further includes a locking ring received within the proximal end of the outer sleeve and extending into the handle to couple the outer sleeve to the handle, the locking ring including a locking protrusion sized and positioned such that when the locking ring is positioned at a target location within the outer sleeve and the outer sleeve is attached to the insertion device handle, the locking protrusion enters an opening in the locking tab to retain the inner sleeve at a desired position within the outer sleeve. (14) The system of embodiment 6, wherein the inner sleeve includes a first adjustment opening extending along a portion of the length of the inner sleeve, and a width of the first adjustment opening transverse to a longitudinal axis of the inner sleeve defines a maximum reduction in diameter of the inner lumen as the diameter when opposing sides of the first adjustment opening contact each other. (15) The system of embodiment 13, wherein the inner sleeve is formed of a first member and a second member, the first member including the first adjustment opening and a first sliding tab, and the second member including a second adjustment opening and a second sliding tab, the first adjustment opening and the second adjustment opening and the first sliding tab and the second sliding tab being sized and positioned such that when the first member and the second member are in a desired position relative to one another, the first sliding tab is slidably received within the first adjustment opening and the second sliding tab is slidably received in the second adjustment opening to couple the first member and the second member to one another, and the first sliding tab and the second sliding tab are slidable within corresponding ones of the first adjustment opening and the second adjustment opening transverse to the longitudinal axis of the first sleeve.

[0051] (16) The system of embodiment 14, wherein distal portions of the first member and the second member are coupled to one another and proximal portions of the first member and the second member are not coupled to one another. (17) The system of embodiment 15, wherein the distal portions of the first member and the second member are joined to one another by welding. (18) The system of embodiment 16, wherein the proximal portions of the first member and the second member are freely movable relative to each other, restricted by a connection between the first sliding tab and the first adjustment opening and a connection between the second sliding tab and the second adjustment opening.

Claims

1. A device for facilitating insertion of a tibial treatment device into a living body, comprising: an outer sleeve of flexible material forming an outer conduit extending longitudinally therethrough for inserting the tibial treatment device to a target site within the living body, the outer sleeve having a distal opening open such that the tibial treatment device inserted through the outer conduit exits the outer sleeve when the outer sleeve is at a desired location within the living body; an inner sleeve received within the outer sleeve and defining an inner conduit within the outer conduit, the inner sleeve forming a protective covering within the outer conduit, the inner sleeve being formed of metal, the inner sleeve being split, with opposite sides of the split portion of the inner sleeve being connected to each other such that a diameter of the inner conduit can be adjusted within a predetermined range in response to a force applied by one of the tibial treatment device and tissue surrounding the outer sleeve; A device comprising:

2. 2. The device of claim 1, wherein the inner sleeve includes a first adjustment opening, the width of the first adjustment opening transverse to a longitudinal axis of the inner sleeve defining a maximum reduction in the diameter of the inner conduit as a diameter when opposing sides of the first adjustment opening contact each other.

3. 3. The device of claim 2, wherein the inner sleeve is formed of a first member and a second member, the first member including the first adjustment opening and a first sliding tab, and the second member including a second adjustment opening and a second sliding tab, the first and second adjustment openings and the first and second sliding tabs being sized and positioned such that when the first and second members are in a desired position relative to one another, the first sliding tab is slidably received within the first adjustment opening and the second sliding tab is slidably received in the second adjustment opening to couple the first and second members to one another, and the first and second sliding tabs are slidable within corresponding ones of the first and second adjustment openings across the longitudinal axis of the inner sleeve.

4. 2. The device of claim 1, wherein the outer sleeve includes a first guidewire lumen extending longitudinally therethrough, and when the device is in a desired position, a guidewire inserted through the first guidewire lumen enters a portion of the tibia adjacent the distal opening of the outer conduit to secure the device in the desired position.

5. 5. The device of claim 4, further comprising a handle attached to a proximal end of the outer sleeve, the handle including a second guidewire lumen extending therethrough, and wherein when the device is in the desired position, a guidewire inserted through the second guidewire lumen enters a non-target femur to secure the device to the non-target femur.

6. A system for treating a tibia, comprising: an insertion device configured for insertion into a living body, the insertion device providing a conduit to a target site in the living body, the insertion device including: an outer sleeve of a flexible material forming an outer lumen extending longitudinally therethrough, a distal opening of the outer lumen being open, such that a tibial treatment device inserted through the outer lumen exits the outer sleeve when the outer sleeve is at a desired position in the living body; and an inner sleeve received within the outer sleeve and defining an inner lumen within the outer lumen, the inner sleeve forming a protective covering within the outer lumen, the inner sleeve being formed of a metal, the inner sleeve being split longitudinally, portions on either side of the split of the inner sleeve being coupled to each other to adjust a diameter of the inner lumen within a predetermined range in response to a force applied by one of an item inserted through the conduit and tissue surrounding the outer sleeve; a wire guide sized and shaped for insertion through the conduit to the target site, the wire guide including a first lumen extending along a central longitudinal axis of the wire guide, the first lumen sized and shaped to slidably receive a guidewire therethrough, and a second lumen laterally offset from and parallel to the first lumen, the second lumen sized and shaped to slidably receive a guidewire therethrough; A system comprising:

7. 7. The system of claim 6, wherein the outer sleeve includes a first guidewire lumen extending longitudinally of the outer sleeve laterally outside of the conduit, and when the insertion device is in the desired position, a guidewire inserted through the first guidewire lumen enters into a portion of the tibia adjacent the distal end of the conduit to secure the insertion device in the desired position.

8. 8. The system of claim 7, wherein the insertion device further includes a handle attached to a proximal end of the outer sleeve, the handle including a second guidewire lumen extending therethrough, and wherein when the insertion device is in the desired position, a guidewire inserted through the second guidewire lumen enters a non-target femur to secure the insertion device to the non-target femur.

9. 7. The system of claim 6, wherein the wire guide includes a first planar surface and a second planar surface connected to each other by an arcuate surface that mirrors the curvature of the inner lumen such that the wire guide is rotatable within the inner lumen, and a thickness of the wire guide defined as the distance separating the first and second planar surfaces is less than the diameter of the inner lumen, such that when the wire guide is received within the lumen, a force exerted on the outer sleeve by surrounding tissue compresses the outer sleeve and the inner sleeve toward the wire guide.

10. The system of claim 8 , wherein the wire guide includes a distal end that is curved to form a blunt, rounded end.

11. 7. The system of claim 6, further comprising a trocar sized and shaped for insertion through the conduit, the trocar including a distal end curved to form a blunt, rounded end.

12. 12. The system of claim 11, wherein the insertion device further includes an insertion device handle attached to a proximal end of the outer sleeve, the insertion device handle including a recess configured to lockingly receive a proximal handle of the trocar, and a length of the trocar is selected such that when the proximal handle of the trocar is lockingly received within the insertion device handle, the blunt, rounded end of the trocar is in a desired position extending distally from the outer sleeve.

13. 7. The system of claim 6, wherein the insertion device further comprises an insertion device handle attached to a proximal end of the outer sleeve, the inner sleeve including a locking tab adjacent its proximal end, and the system further comprises a locking ring received within the proximal end of the outer sleeve and extending into the insertion device handle to couple the outer sleeve to the insertion device handle, the locking ring including a locking protrusion sized and positioned such that when the locking ring is positioned at a target location within the outer sleeve and the outer sleeve is attached to the insertion device handle, the locking protrusion enters an opening in the locking tab to retain the inner sleeve in a desired position within the outer sleeve.

14. 7. The system of claim 6, wherein the inner sleeve includes a first adjustment opening, the width of the first adjustment opening transverse to the longitudinal axis of the inner sleeve defining a maximum reduction in the diameter of the inner lumen as the diameter when opposing sides of the first adjustment opening contact each other.

15. 15. The system of claim 14, wherein the inner sleeve is formed of a first member and a second member, the first member including the first adjustment opening and a first sliding tab, and the second member including a second adjustment opening and a second sliding tab, the first and second adjustment openings and the first and second sliding tabs being sized and positioned such that when the first and second members are in a desired position relative to one another, the first sliding tab is slidably received within the first adjustment opening and the second sliding tab is slidably received in the second adjustment opening to couple the first and second members to one another, and the first and second sliding tabs are slidable within corresponding ones of the first and second adjustment openings across the longitudinal axis of the inner sleeve.

16. 16. The system of claim 15, wherein distal portions of the first member and the second member are coupled to one another and proximal portions of the first member and the second member are not coupled to one another.

17. The system of claim 16 , wherein the distal portions of the first and second members are coupled together by welding.

18. 17. The system of claim 16, wherein the proximal portions of the first and second members are free to move relative to one another, restricted by a connection between the first sliding tab and the first adjustment opening and a connection between the second sliding tab and the second adjustment opening.

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