Devices and systems for facilitating insertion of a bone treatment device

Abstract

An apparatus includes an outer sleeve of flexible material forming an outer conduit extending longitudinally through the outer sleeve for insertion of a bone treatment device ("BTD") to a target site within a living body. A distal opening of the outer conduit is open so that a BTD inserted through the outer conduit exits the outer sleeve adjacent a target portion of a bone when the outer sleeve is in a desired position within the body. The apparatus also includes an inner sleeve received within the outer sleeve and defining an inner conduit within the outer conduit to form a sheath. The inner sleeve is split along a longitudinal direction. Portions of the inner sleeve on opposite sides of the split are coupled to one another so that a diameter of the inner conduit is adjustable in response to a force exerted on the inner conduit by one of the BTD and tissue surrounding the outer sleeve.

Description

Technical Field

[0001] This disclosure relates in its entirety to a means and system for facilitating the insertion of a bone treatment device into a living body, and more particularly to a means and system for facilitating the insertion of an intramedullary nail into bone (e.g., the tibia). Background Technology

[0002] The procedure for inserting an intramedullary (IM) nail into the tibia can be performed using the suprapatellar approach. While this technique generally facilitates the treatment of proximal and distal tibial fractures, it can apply increased stress to the knee joint during drilling and reaming to create the entry path for the IM nail, as well as during the insertion of the nail itself. Summary of the Invention

[0003] This disclosure relates to a device for facilitating the insertion of a bone treatment device into a living body, the device comprising a flexible material outer sleeve forming an external conduit extending longitudinally through the outer sleeve for inserting the bone treatment device into a target site within the body. The distal opening of the external conduit is open such that, when the outer sleeve is in the desired position within the body, the target portion of the bone adjacent to the bone through the external conduit exits the outer sleeve.

[0004] The device also includes an inner sleeve received within an outer sleeve and defining an inner catheter within an outer catheter. The inner sleeve forms a cap within the outer catheter. The inner sleeve is made of metal. The inner sleeve is longitudinally split. Portions of the inner sleeve on opposite sides of the split are joined together, such that the diameter of the inner catheter can be adjusted within a predetermined range in response to a force applied to the inner catheter by either the bone treatment device or the tissue surrounding the outer sleeve.

[0005] Embodiments of the invention also relate to a system for treating bone, comprising an insertion device configured for insertion into the living body, the insertion device providing a conduit to a target site within the body. The insertion device includes an outer sleeve of flexible material forming an outer lumen extending longitudinally through the outer sleeve. A distal opening of the outer lumen is open such that, when the outer sleeve is in a desired position within the body, a bone treatment device inserted through the outer lumen, adjacent to a target portion of the bone, exits the outer sleeve, and an inner sleeve is received within the outer sleeve and defines an inner lumen within the outer lumen. The inner sleeve forms a cap within the outer lumen. The inner sleeve is formed of metal. The inner sleeve is split longitudinally. Portions of the inner sleeve on opposite sides of the split are joined to each other such that the diameter of the inner lumen is adjustable within a predetermined range in response to forces exerted on the inner lumen by either an article inserted through the conduit or tissue surrounding the outer sleeve.

[0006] The system also includes a guidewire, sized and shaped for insertion through a catheter into a target site. The guidewire includes a first lumen extending along its central longitudinal axis. The first lumen is sized and shaped to slidably receive a guidewire passing through it. The guidewire 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 passing through it. Attached Figure Description

[0007] Figure 1 A perspective view of a device according to one embodiment is shown, the device being positioned adjacent to and within a leg;

[0008] Figure 2 It shows Figure 1 Exploded view of the equipment;

[0009] Figure 3 The anatomy of the knee joint is shown. Figure 1 A view of the device along with the guidewire already inserted into the tibia;

[0010] Figure 4 It shows the relationship with Figure 1 A view of the proximal end of a wire used with the equipment;

[0011] Figure 5 A perspective view of a wire guide according to another embodiment is shown, the wire guide including a portion with an increased diameter and a portion with a decreased diameter;

[0012] Figure 6 It shows the use with a drill bit. Figure 1 A perspective view of the components;

[0013] Figure 7 The combination is shown Figure 1 A perspective view of the device inserted into the IM nail in the tibia;

[0014] Figure 8 A perspective view of a protective component according to another embodiment is shown;

[0015] Figure 9 It shows Figure 8 A partial cross-sectional view of the component;

[0016] Figure 10 It shows Figure 8 A view of the core protective sleeve of the component;

[0017] Figure 11 It shows that it can form Figure 10 A perspective view of the material sheet of the core protective sleeve;

[0018] Figure 12 It shows Figure 11 sheet and Figure 10 End view of the core protective sleeve;

[0019] Figure 13 A perspective view of the protection component according to yet another embodiment is shown;

[0020] Figure 14 It shows Figure 13 End view of the protection component;

[0021] Figure 15 It shows Figure 13 A cross-sectional view of the protective components;

[0022] Figure 16 It shows Figure 13 The internal protective sleeve of the component implementation scheme;

[0023] Figure 17 It shows that it can form Figure 16 A perspective view of the material sheet of the core protective sleeve;

[0024] Figure 18 It shows Figure 13 An internal protective sleeve for another embodiment of the component;

[0025] Figure 19 It shows that it can form Figure 18 A perspective view of the material sheet of the core protective sleeve;

[0026] Figure 20 It shows Figure 19 Two sheets, positioned to be joined to form Figure 18 Core protective sleeve;

[0027] Figure 21 A side view of the inner protective sleeve according to another embodiment is shown;

[0028] Figure 22 It shows Figure 21 A cross-sectional view of the internal protective sleeve;

[0029] Figure 23 It shows what is contained within the outer sleeve. Figure 21 A cross-sectional view of the internal protective sleeve;

[0030] Figure 24 A perspective view of a protective component according to another embodiment is shown;

[0031] Figure 25 A side view of a cannula according to one embodiment is shown;

[0032] Figure 26A perspective view of a wire guide according to another embodiment is shown;

[0033] Figure 27 It shows that it can be formed Figures 30 to 32 Side view of the material sheet of the core protective sleeve;

[0034] Figure 28A It shows bending for forming Figures 30 to 32 The initial shape of the core protective sleeve Figure 27 Front view of the sheet material;

[0035] Figure 28B It shows bending for forming Figures 30 to 32 The initial shape of the core protective sleeve Figure 27 A side view of the sheet material;

[0036] Figure 29 It shows bending for forming Figures 30 to 32 The initial shape of the core protective sleeve Figure 27 The bottom view of the sheet material;

[0037] Figure 30 It shows the result of, as Figure 27 The side view of the core protective sleeve formed from the sheet shown;

[0038] Figure 31 It shows the result of, as Figure 27 The front view of the core protective sleeve formed from the sheet material shown;

[0039] Figure 32 It shows the result of, as Figure 27 A perspective view of the core protective sleeve formed from the sheet material shown;

[0040] Figure 33A A perspective view of the handle of a protective component according to one embodiment is shown, wherein the two halves of the handle are separated from each other;

[0041] Figure 33B It shows Figure 33A A top view of half of the handle;

[0042] Figure 34 It shows Figure 33A A cross-sectional view of the guidewire opening at the shank;

[0043] Figure 35 It shows the relationship with Figure 33A Side view of the locking ring used together with the handle;

[0044] Figure 36 It shows Figure 35 A perspective view of the locking ring;

[0045] Figure 37 It shows the inclusion of Figure 33A The handle and Figure 35 The outer sleeve is used in the implementation of the locking ring protection component;

[0046] Figure 38 A perspective view of a fixed guidewire according to one embodiment is shown;

[0047] Figure 39 Showing with Figure 38 Fixed guide wire Figure 13 A top view of the protective components; and

[0048] Figure 40 Showing with Figure 38 Fixed guide wire Figure 13 Side view of the protective components. Detailed Implementation

[0049] The invention can be further understood with reference to the following description and accompanying drawings, wherein like reference numerals refer to similar elements. Exemplary embodiments describe a device and procedure for suprapatellar insertion of a tibial IM nail. As used herein, the terms distal and proximal refer to the direction away from the attachment point of the outrigger to the body (distal) and towards the attachment point of the outrigger to the body (proximal). Although the embodiments described herein are specifically configured for a procedure for suprapatellar insertion of a tibial IM nail, those skilled in the art will understand that the embodiments described herein can also be used for procedures involving spinal surgery.

[0050] As those skilled in the art will understand, tibial fractures can be treated by inserting an IM nail, and in some cases, the IM nail is inserted using a suprapatellar method. In these cases, instruments such as drills and reamers, along with the IM nail itself, are inserted into the proximal end of the tibia via the space between the patella and femur. This method requires patellar replacement and may exert stress on the patella, its supporting anatomy, and surrounding tissues. Generally, a protective sleeve is inserted through this space to protect surrounding tissues from injury, which would otherwise result from contact between the instrument or the nail itself and the surrounding tissues. The tissues around this space are displaced and subjected to significant stress throughout the time the protective sleeve remains in position. Embodiments of the present invention provide protection for the surrounding tissues while reducing the stress exerted on them during the procedure. Generally, such procedures involve reducing the fracture (using any known technique), followed by determining the length and diameter of the IM nail using any known technique. Subsequently, an incision is made and the insertion site of the IM nail is determined. Furthermore, techniques such as blunt dissection may be employed to loosen the patella and allow it to be removed from the femur.

[0051] like Figure 1 and Figure 2 As shown, the following text can be used. Figure 13The protective sleeve assembly 212 is described in detail below. A cannula 22 is then inserted through the protective sleeve assembly 212, and the assembly is inserted into the entry site so that the IM pin enters the body via an incision and passes through the knee joint, for example, between the articular surface of the patella 24 and the distal femur 26 to reach the proximal end of the tibia 28. The protective sleeve assembly 212 is then secured in place by placing a guidewire into either the tibia or the femur, as will be described in more detail below.

[0052] like Figures 38 to 40 As shown, tibial fixation can be performed using a fixation guidewire 100. The fixation guidewire 100 extends from a proximal end 103 to a distal end 105 and includes, for example, a shoulder or stop 102 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 entering the protective sleeve assembly 212 beyond a desired depth. The stop 102 is positioned such that when the fixation guidewire 100 is inserted into the tibia as needed, the contact between the stop 102 and the protective sleeve assembly 212 holds the protective sleeve assembly 212 against the tibia in the desired position.

[0053] As described below, the protective sleeve assembly 212 includes an inner sleeve made of a metal such as stainless steel and an outer sleeve made of a deformable material such as flexible plastic. Therefore, the inner metal sleeve protects the outer plastic sleeve from damage to the softer plastic material that may occur during drilling, reaming, etc. The device is inserted until the cannula 22 reaches the surface of the tibia 28 at the entry point B, for example, the anterior surface of the proximal tibia.

[0054] At this point, the cannula 22 is removed, and as... Figure 3 and Figure 4 As shown, the guide wire 30 is inserted through the protective sleeve assembly 212 to guide the first guide wire 32 through the entry site along the desired path to be drilled out for inserting the IM nail into the medullary canal of the tibia 28. Those skilled in the art will understand that the guide wire 32 can be inserted using any known technique as needed. In this case, the guide wire 32 is placed into the tibia 28 via the guide wire 30, which is inserted into the entry site through the protective sleeve assembly 212. The guide wire 32 passes through a central lumen 34 extending along the longitudinal axis of the guide wire 30 (in this embodiment, coinciding with the central axis of the protective sleeve assembly 212) to enter the tibia 28 along a path parallel to and defined by the path of the central lumen 34 of the guide wire 30. The positioning of the guide wire 32 can then be checked and adjusted using the guide wire 30 as described below.

[0055] After checking the position of guidewire 32, if it is determined that the position of guidewire 32 should be adjusted, the surgeon removes guidewire 30 by withdrawing guidewire 30 over guidewire 32 until guidewire 32 is removed from the guidewire, and then reinserting guidewire 32 into biased lumen 36, which is radially biased to and parallel to the central lumen 34. Guidewire 30 is then passed over guidewire 32 through protective sleeve assembly 212 to the proximal surface of the tibia and rotated as needed until the central lumen 34 is aligned with the desired path, along which the second guidewire 32 is intended to be inserted into the tibia 28. The second guidewire 32 is then placed as needed and the first guidewire 32 is removed. Furthermore, as... Figure 5 As shown, according to another embodiment, the outer diameter of the guide 30' varies along its length to allow the protective sleeve assembly to partially collapse radially as the guide 30' is received through the protective sleeve assembly 212. Specifically, the outer diameter of the guide 30' includes a distal portion 31 and a proximal portion 31', the outer diameter of which substantially corresponds to the inner diameter of the protective sleeve assembly 212 at its distal end, which contacts the tibia when the guide 30' is fully inserted, and the proximal portion, when the guide 30' is fully inserted, is received in the proximal end of the protective sleeve assembly 212 separated by a central diameter-reducing portion 33.

[0056] This ensures that the guide wire 30' is properly centered within the protective sleeve assembly 212, while allowing the central portion of the protective sleeve assembly 212 to partially collapse radially, thereby reducing the pressure applied to the surrounding tissue, as will be described in more detail below. Figure 6 As shown, drill bit 38 is then advanced over guide wire 32 (second guide wire) and pushed through protective sleeve assembly 212 to the access site, where the surgeon drills an access hole to the medullary canal, as those skilled in the art will understand. The surgeon then removes the drill bit and, if necessary, may advance a reamer (or reamer rod, i.e., a flexible steel rod 2.5 mm to 3 mm long) over guide wire 32 to enlarge the drilled opening and / or medullary canal, as those skilled in the art will understand.

[0057] like Figure 7As shown, once the access path and medullary canal are prepared, the reamer can be removed and the IM nail 40 can be prepared for insertion. As those skilled in the art will understand, the proximal end of the IM nail 40 can be coupled to the insertion shank 42, and the distal end of the IM nail 40 is inserted into the access path through the protective sleeve assembly 212. During the time between the completion of the access path / medullary canal preparation and the preparation of the IM nail 40 for insertion, the protective sleeve assembly 212 partially collapses radially inward, allowing the surrounding tissues to relax somewhat, thereby reducing the trauma associated with their displacement. This also reduces the time the tissues in the suprapatellar space are subjected to a high level of stress. The IM nail 40 can then be inserted into the tibia 28 and locked in place using any known technique.

[0058] like Figures 8 to 12 As shown, another embodiment of the protective sleeve assembly 112 for inserting the IM pin 40 via, for example, a suprapatellar method can be used with a separate shank. Specifically, the sleeve 112 includes an outer soft protective sleeve 114 extending from a proximal end base 115, which is coupled to the shank in a known manner. The outer sleeve 114 surrounds a metal inner core sleeve 116, which protects the outer sleeve 114 from damage by drill reamers or similar devices inserted through the assembly 112. The core sleeve 116 includes radial flanges 118 that mate with corresponding structures of the outer sleeve 114 to hold the core sleeve 116 in a desired position within the outer sleeve 114.

[0059] Furthermore, the radial flange 118 makes the proximal and distal ends of the core sleeve 116 substantially incompressible, thereby ensuring that the diameter of the distal end of the core sleeve 116 remains sufficiently large to receive the article, making it easier to pull an article that has been inserted distally beyond the assembly 112 back into the assembly 112. The core sleeve 116 is configured to allow the core sleeve 116 to deflect radially inward when subjected to compressive forces (e.g., forces exerted by surrounding tissue) when its lumen 120 is not occupied by incompressible articles (e.g., IM nails, drills, reamers, etc.).

[0060] like Figure 11 and Figure 12As shown, the core sleeve 116 of this embodiment can be formed from a metal sheet 121. The sheet can be formed from any suitable material, such as any hardened spring steel wound around a longitudinal axis L to form a cylinder and bent above a bending axis B to form a radial flange 118. The sheet 121 includes a series of longitudinal gaps 124 that enhance the flexibility of the core sleeve 116, such that when no instrument passes through the sleeve assembly 112 (or when the outer diameter of the article received within the assembly 112 is smaller than the inner diameter of the core sleeve 116), the assembly 112 collapses radially inward to reduce damage to the tissue surrounding the assembly 112. Furthermore, the outer sleeve 114 of this embodiment includes two guidewire lumens 126 extending on opposite sides of the lumen 120. Although the guidewire lumens 126 extend parallel to the lumen 120 in this embodiment, the guidewire lumens 126 can extend in different directions relative to the lumen 120. As those skilled in the art will understand, the guidewire lumen 126 can be used to secure assembly 112 to a desired location on the tibia by inserting a guidewire through the lumen into the proximal end of the tibia. In another embodiment, the core sleeve 116 may be formed of a tube of any suitable material having a longitudinal gap similar to the longitudinal gap 124.

[0061] Figures 13 to 15 A protective sleeve assembly 212 according to another embodiment is shown, extending from a shank 213 at its proximal end to a distal end 215, the distal end being shaped to be substantially flat against the target portion of the bone. An outer sleeve 214 surrounds a metal inner sleeve 216, which protects the outer sleeve 214 from damage by drill bits, reamers, or the like inserted through the assembly 212. The distal end 215 is preferably made more rigid than the rest of the device so that it remains fully open, and the distal end 215 includes a bevel 217 to facilitate the retraction of items (e.g., reamers) that have been inserted distally beyond the assembly 212 by ensuring that the diameter of the distal end of the assembly 212 remains sufficiently accommodating. The core sleeve 216 is configured to allow the core sleeve 216 to deflect radially inward when subjected to compressive forces (e.g., forces exerted by surrounding tissue) when its lumen 220 is not occupied by incompressible articles (e.g., IM nails, drills, reamers, etc.).

[0062] like Figure 13 As shown, the handle 213 also includes two guidewire insertion openings 219 configured to allow a guidewire to be inserted into the femur to secure the component 212 to the femur, or, if desired, as an alternative to or supplement to securing the component 212 to the tibia. The openings 219 are formed as substantially tapered openings to allow the guidewire to be angled relative to the handle 213 at any desired orientation within a permissible angular range. For example, the openings 219 may allow the guide to be inserted at any angle into a cone with a apex angle of 55 degrees.

[0063] like Figures 16 to 20 As shown, the core sleeve 216 of this embodiment may be formed of one or more sheets 222 of metal or other materials similar to those described above regarding core sleeve 116. Figure 16 and Figure 17 As shown, the core sleeve 216' is formed by winding a single sheet 222' around a longitudinal axis L to form a generally oval structure having longitudinal openings 224 on its opposite sides. The ends of the wound sheet 222' can then be welded to form an oval tubular structure.

[0064] like Figure 17 As shown, sheet 222 includes a series of transverse slits 226 on its outer edge. Longitudinal openings 224, forming slots on the opposite side of the core sleeve 216', are formed by bending fins 228 formed between adjacent slits in the slits 226 radially outward. Figure 15 As shown, the resulting structure of the core sleeve 216' is fitted into the correspondingly shaped interior space of the outer sleeve 214. In another embodiment, the longitudinal opening 224 may be formed along any curve, such as a helical curve. In another embodiment, the core sleeve 216 may be formed from a tube made of the same material as described above with respect to the core sleeve 116, having a longitudinal opening similar to the longitudinal gap 224 and a transverse slit similar to the transverse slit 226.

[0065] Sheet 222' also includes a longitudinal slit 228, with a series of transverse slits 230 intersecting the slit 228 at regular intervals. The core sleeve 216 is shaped and configured to enhance the compressibility of assembly 212 in a direction transverse to axis L, particularly in the direction across the width of slot 224. Assembly 212 is configured to have maximum deflectability in the direction in which the surrounding tissue applies the maximum compressive force. That is, for this device, assembly 212 is designed to compress more easily in the longitudinal direction, as this is the direction of the maximum force applied to assembly 212 by the surrounding tissue.

[0066] As those skilled in the art will understand, the width of the longitudinal opening 224 (the range of the opening 224 in the direction transverse to the longitudinal axis of assembly 212) defines the maximum deflection of the core sleeve 216, and thus the maximum deflection of assembly 212. That is, when deflected to its maximum extent, the opposite sides of the longitudinal opening 224 will contact each other. As described above, when no instrument passes through the sleeve assembly 212 (or when the outer diameter of the article received within the assembly 212 is smaller than the inner diameter of the core sleeve 216), assembly 212 collapses radially inward to reduce damage to the tissue surrounding assembly 212. Furthermore, the outer sleeve 214 of this embodiment includes two guidewire lumens 232 parallel to the lumen 220 and extending on opposite sides of the lumen.

[0067] like Figures 18 to 20 As shown, the inner core protective sleeve 216" can be formed from two sheets 222", each sheet being pressed into a substantially symmetrical shape and welded together at the edges of the sheets. Unlike sleeve 216', sleeve 216" does not include the lateral slot 224. Instead, the fins 226' of the sheets 222" are bent to extend laterally away from the central axis L@ of sleeve 216" such that they form wings 225 as a set on either side of sleeve 216". Similar to the opening 224, the width of the wings 225 defines the maximum deflection of the core sleeve 216" and thus the maximum deflection of the assembly in which the core sleeve is mounted. That is, when deflected to the maximum extent, the opposite sides of the wings 225 contact each other.

[0068] Figures 21 to 23 A core protector sleeve 312 is shown for inclusion in any protective sleeve assembly described herein. The sleeve 312 is configured to insert into any outer sleeve described herein to form a durable protective sleeve assembly that resists damage during drilling and reaming processes. In this embodiment, the core protector sleeve 312 includes a proximal portion 314 having a first diameter and a distal portion 316 having a second diameter greater 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 for proper aiming at the operating head 318 of the reamer or drill bit 320, while the decreased diameter proximal portion 314 is sized to receive the drive shaft 322 of the reamer or drill bit 320 with a clearance that allows partial collapse of the protective sleeve assembly.

[0069] As those skilled in the art will understand, the inner diameters of the proximal portion 314 and the distal portion 316 are respectively configured to allow a sufficiently large clearance with the portion of the reamer or drill bit 320 housed therein, enabling the reamer or drill bit 320 to rotate freely within the core sleeve 312. Therefore, only a portion of the distal portion 316 of the core sleeve 312 is prevented from radially collapsing, thus reducing tissue stress. Consequently, when the core sleeve 312 is used, a large portion of its length is freely compressible, reducing stress on the surrounding tissue. Figure 23 As shown, the gap 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 protective sleeve 312, thereby allowing the protective sleeve 312 to partially collapse radially along the entire portion. It should be understood that the core protective sleeve 312 can only be used with devices having a reduced-diameter shaft that extends along most of the device length.

[0070] like Figure 24As shown, the protective sleeve assembly 412 according to another embodiment is substantially similar to the protective sleeve assembly 212 described above, except that assembly 412 does not include any guidewire lumen, thereby providing a reduced profile and further reducing damage to surrounding tissues. That is, the protective sleeve assembly 412 can be selected by a user who does not wish to have a guidewire inserted into the tibia to fix the assembly 412 in the desired position. In this case, the assembly 412 will be secured only via a guidewire inserted through the guidewire opening 419 in the handle 413. Figure 24 As shown, the protective sleeve assembly 412 extends from its proximal end 413 to its distal end 415, the shape of which is set to substantially flat against the target portion of the bone.

[0071] An outer sleeve 414 surrounds a metal inner core sleeve 416, which protects the outer sleeve 414 from damage by drill bits, reamers, or the like inserted through the assembly 412. The core sleeve 416 may be constructed according to any of the embodiments described herein. The distal end 415 is preferably made more rigid than the rest of the device so that it remains fully open, and the distal end 415 includes a bevel 417 to facilitate the retraction of items (e.g., reamers) that have been inserted distally beyond the assembly 412 by ensuring that the diameter of the distal end of the assembly 412 remains sufficiently large to receive the item.

[0072] As described above, the core sleeve 416 is configured to allow it to deflect radially inward under compressive forces (e.g., forces exerted by surrounding tissue) when its lumen is not occupied by incompressible articles (e.g., IM nails, drills, reamers, etc.). The shank 413 also includes two guidewire insertion openings 419 configured to allow guidewire insertion into the femur to secure the assembly 412 to the femur. The openings 419 are formed as substantially tapered openings to allow the guidewire to be angled relative to the shank 413 at any desired orientation within a permissible angular range.

[0073] Figure 25 A cannula 430 for use with any of the protective sleeve assemblies described herein is shown. The cannula 430 includes a blunt, tapered distal tip 432. The cannula 430 is sized such that when the shank 434 at its proximal end is placed in a correspondingly sized and shaped recess in the shank of the protective sleeve assembly (e.g., within a recess 420 in the shank 413 of assembly 412), the distal end 432 protrudes distally from the sleeve 414 to provide a blunt disengagement tip, thereby facilitating insertion of the combined cannula 430 and assembly 412 over the guidewire into the target side adjacent to the proximal end of the tibia.

[0074] The cannula 430 includes a reduced-diameter proximal shaft 436, the diameter of which is smaller than the diameter of the distal tip 432. In this embodiment, the diameters of the distal tip 432 and the proximal portion 438 substantially correspond to the inner diameter of the core sleeve 416, allowing the cannula 430 to be centered within the assembly 412. The cannula 430 also includes an optional locking structure 440 configured to snap into a corresponding structure in a recess 420 to retain the cannula 430 in a desired position within the assembly 412. As those skilled in the art will understand, a guide such as the guide 30 can be used to reinforce the protective assembly during insertion and to provide a tapered tip to facilitate blunt dissection when the protective sleeve assembly is inserted into a desired position adjacent to the proximal end of the tibia.

[0075] like Figure 26 As shown, the guide wire 450 according to an alternative embodiment includes a central lumen 452 extending along the longitudinal axis of the guide wire 450 (in this embodiment, coinciding with the central axis of the protective sleeve 412 in which the guide wire is inserted). As described above, if it is determined that the position of the guide wire needs to be adjusted, the surgeon removes the guide wire 450 by withdrawing the guide wire 450 over the guide wire until the guide wire leaves the guide wire, and then reinserting the guide wire into an offset lumen 454 that is radially biased to and parallel to the central lumen 452. The guide wire 450 then passes over the guide wire through the protective sleeve 412 to the proximal surface of the tibia and is rotated as needed until the central lumen 452 is aligned with the desired path along which the second guide wire is intended to be inserted into the tibia. The second guide wire is then placed into the tibia via the central lumen 452 as needed, and the first guide wire is removed. Figure 26 As shown, the distal portion 456 of the wire guide 450 is formed as part of a cylinder with a scraped flat surface 458.

[0076] In an alternative embodiment, the guide wire 450 is inserted directly into the tibia through an incision. The guide wire 450 is inserted into the tibia in a manner similar to that described above, and a protective sleeve 412 is inserted directly above the guide wire without the use of a cannula. The protective sleeve 412 is then secured to the tibia, femur, or both. After securing the protective sleeve 412, the guide wire 450 is removed. In such an embodiment, the guide wire 450 is manufactured to be as thin as possible; that is, the distal portion of the guide wire 450 has a reduced diameter, a blunt tip, and flattened sides.

[0077] The distal portion 456 of this embodiment is sized to be as small as possible while accommodating both the central lumen 452 and the offset lumen 454. This allows the protective sleeve assembly inserted therein to partially collapse, thereby further reducing damage to surrounding tissues. As those skilled in the art will understand, the length of the guide 450 is selected such that when the guide 450 is fully inserted into the protective sleeve assembly, the distal end 460 of the guide 450 contacts the tibia, while the proximal end 462 extends proximally beyond the handle of the protective sleeve assembly through which it has been inserted. Figure 26 As shown, the distal end 460 of the guide wire 450 is formed as a rounded recessed end to facilitate blunt dissection of the tissue, so that the guide wire 450 can be optionally used to replace the cannula 430 to facilitate the insertion of the protective sleeve assembly above the guide wire into the target site at the proximal end of the tibia.

[0078] like Figures 27 to 32 As shown, a core sleeve 500, which can be used within any protective sleeve assembly described herein, may be formed from two sheets 502 of metal or other materials similar to those described above with respect to core sleeve 116. Figures 27 to 32 As shown, the core sleeve 500 according to this embodiment is formed by bending a pair of sheets 502 about a longitudinal axis L, such that each sheet 502 forms 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 receiving tab defining a tab receiving opening 508 along a first side surface, and corresponding plurality of locking tabs 506 formed at corresponding positions along the axis L on opposite side surfaces.

[0079] The size and position of each locking tab 506 of the first sheet 502 are set such that, after the sheets 502 have been bent into their semi-tubular shapes, they are received through the tab receiving opening 508 of the correspondingly positioned receiving tab 504 of the other sheet 502. Figure 28A , Figure 28B and Figure 29 As shown, after the sheets 502 in this embodiment have been bent into their generally semi-tubular shapes, the receiving tabs 504 extend generally along the tangent of the tube formed by the sheets 502, while the locking tabs 506 project radially outward 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 outward through the tab receiving opening 508 of its corresponding receiving tab 504.

[0080] In subsequent operations, such as Figures 30 to 32As shown, each locking tab 506 is then bent toward a position where the outer end of the locking tab 506 extends rearward toward the point of connection between the locking tab and the sheet 502, the locking tab extending substantially parallel to the receiving tab 504 through which it extends from the sheet. 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 surrounding tissue in the same manner as described above with respect to the other core sleeves. The range of this contraction C is defined by the dimension of the tab receiving opening 508 tangential to the tubular structure minus the thickness of the tab 506 (i.e., by the range of movement allowed within each of the tabs 506 in its corresponding tab receiving opening 508).

[0081] Furthermore, the two sleeves 502 are joined together, for example, by welding at their distal ends 510, while the proximal ends 512 of the sheet 502 are not welded together. Specifically, in this embodiment, the distal ends 510 are laser-welded along the seam 514. Those skilled in the art will understand that this will allow the tubular structure of the core sleeve according to this embodiment to unfold more easily at the proximal end 512 of the core sleeve when the bent portion of the IM nail is forced through the core sleeve.

[0082] Furthermore, the connection between the locking tab 506 and the receiving tab 504 enhances the resistance of the core sleeve according to this embodiment to shear forces emanating from the patellar-femoral joint when the bent IM nail is pushed through it. Specifically, when the bent IM nail is pushed through the protective sleeve, one half of the core sleeve (e.g., along the inner diameter of the bend in the IM nail) can be pushed to migrate proximally within the protective sleeve, while the other half experiences a force pushing it in the opposite direction. This establishes shear forces acting between the two sheets 502, which, in this embodiment, are resisted by the contact between the locking tab 506 and the distal surfaces 508', 508" of the proximal end of the tab receiving opening 508, respectively, preventing migration of the sheets 502 relative to each other as the IM nail is inserted through the sheets.

[0083] Furthermore, the connection between the locking tab 506 and the distal surfaces 508', 508" of the proximal end of the tab receiving opening 508 prevents the core sleeve from spreading radially outward as the nail bends through, thereby minimizing pressure on the knee joint. Additionally, each sheet in the sheet 502 includes a tab 516, as described below, for locking the core sleeve to the shank to prevent distal migration of the core sleeve within the protective sleeve as the IM nail is pushed distally through it.

[0084] Figure 33 to Figure 37As shown, a protective sleeve assembly 550 used, for example, with a core sleeve 500 includes an outer sleeve 560, a handle 580, and a locking ring 600 connecting the outer sleeve 560, the core sleeve 500, and the handle 580 to each other. As shown in FIG33, the handle 580 is formed of two interlocking halves to receive a laterally outwardly projecting bonding platform 562 at the proximal end 564 of the sleeve 560. The bonding platform 562 is received within a cavity 582 of correspondingly defined size and shape formed between the two halves of the handle 580. Furthermore, after the core sleeve 500 has been inserted into the outer sleeve 560, the locking ring 600 is positioned within the proximal opening 564, wherein the mounting posts 602 of the locking ring 600 are received within a recess 566 on either side of the opening 564 until the distal side 604 of each of the posts 602 rests on the proximal-facing surface at the distal end of the recess 566.

[0085] When the locking ring 600 is inserted distally into the opening 564, the laterally projecting protrusions 606 of the locking ring slide into the core sleeve 500 until each of the protrusions 606 enters an opening beneath a corresponding tab in the tabs 516 of the core sleeve 500, thereby locking the core sleeve 500 in the desired position within the outer sleeve 560. In this embodiment, the outer sleeve 560 does not include lateral guidewire lumens for tibial fixation. Therefore, in this embodiment, the post 602 extends proximally from the outer sleeve 560 to engage the openings 584 in the handle 580, which, in embodiments including such tibial fixation guidewire lumens, would extend through the handle 580 to access these guidewire lumens. As those skilled in the art will understand, the outer sleeve 560 of this embodiment may be substantially similar to any of the outer sleeves described above, differing only in the structure at the proximal end for securing the outer sleeve 560 to the handle 580.

[0086] The locking ring 600 of this embodiment not only locks the core sleeve 500 in the desired position within the outer sleeve 560, but also serves to plug the tibial fixation guidewire opening in the handle 580. Those skilled in the art will understand that for an outer sleeve including a lateral guidewire for tibial fixation, the locking ring will be constructed similarly to locking ring 600, except that the post 602 will not be included, leaving the guidewire opening 584 unobstructed. It should be understood that the guidewire lumen of such an outer sleeve will be 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 pass through the guidewire lumen in the same manner as described above to reach the proximal surface of the tibia.

[0087] When the two halves of the handle 580 are joined together, a snap-fit ​​mechanism above the bonding platform 562 locks the outer sleeve 560 to the handle 580. For example... Figure 33A and Figure 34As shown, the handle 580 includes two guidewire openings 586, the purpose of which is to allow the guidewire to be inserted into the femur to stabilize the protective sleeve assembly 500. Figure 34 As shown, each guidewire opening in the guidewire opening 586 is formed as part of a cone with a apex angle of 55 degrees (i.e., the guidewire can be inserted through any opening in the opening 586 at an angle of up to 27.5 degrees in any direction from the central axis CA of the opening 586). However, those skilled in the art will understand that this angle α can be any desired value that allows for the required femoral fixation. As described above, the size, shape, and structure of the groove 588 at the proximal end of the handle 580 are configured to receive and lock in place a cannula needle as described above or any other device that will be inserted through the central lumen of the assembly 550.

[0088] Although these embodiments have been described in conjunction with suprapatellar insertion of a tibial IM nail, those skilled in the art will understand that the system can also be used in spinal surgery. Furthermore, while specific embodiments and methods have been described, it should be understood that various modifications different from those discussed 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 replace those specifically shown and described, certain features may be used independently of other features, and in some cases, the specific application of elements may be reversed or inserted, all without departing from the spirit or scope of the invention.

Claims

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 through the outer sleeve for insertion of the bone treatment device into a target site within the body, a distal opening of the outer conduit being open so that the bone treatment device inserted through the outer conduit exits the outer sleeve adjacent a target portion of a bone when the outer sleeve is in a desired position within the body; and an inner sleeve received within the outer sleeve and defining an inner conduit within the outer conduit, the inner sleeve forming a sheath within the outer conduit, the inner sleeve being formed of metal, the inner sleeve being split, portions of the inner sleeve on opposite sides of a split being coupled to one another so that a diameter of the inner conduit is adjustable within a predetermined range in response to a force exerted on the inner conduit by one of the bone treatment device and tissue surrounding the outer sleeve. the inner sleeve includes a first adjustment opening extending longitudinally along a portion of a length of the inner sleeve, a 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 opposite sides of the first adjustment opening are in contact with one another.

2. The apparatus of claim 1, 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 so 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, thereby coupling the first and second members to one another, the first and second sliding tabs being slidable within the respective adjustment openings transverse to the longitudinal axis of the inner sleeve.

3. The apparatus of claim 2, wherein, the outer sleeve includes a first guide wire lumen extending longitudinally along the outer sleeve, the first guide wire lumen being for a guide wire inserted therethrough to enter a portion of a bone adjacent the distal opening of the outer conduit when the device is in a desired position to anchor the device in the desired position.

4. The apparatus of claim 1, wherein, 5. The device of claim 4, further comprising: a handle mounted to a proximal end of the outer sleeve, the handle including a second guide wire lumen extending through the handle, the second guide wire lumen being for a guide wire inserted therethrough to enter a non-target bone when the device is in the desired position to secure the device to the non-target bone relative to a target portion of a bone.

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 comprising: an outer sleeve of flexible material forming an outer lumen extending longitudinally through the outer sleeve, a distal opening of the outer lumen being open such that a bone treatment device inserted through the outer lumen exits the outer sleeve adjacent a target portion of a bone when the outer sleeve is in a desired position within the body; and an inner sleeve received within the outer sleeve and defining an inner lumen within the outer lumen, the inner sleeve forming a cap within the outer lumen, the inner sleeve being formed of metal, the inner sleeve being split along a longitudinal direction, portions of the inner sleeve on opposite sides of the split being coupled to one another such that a diameter of the inner lumen is adjustable within a predetermined range in response to a force exerted on the inner lumen by one of an article inserted through the conduit and tissue surrounding the outer sleeve; and 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 being sized and shaped to slidably receive a guide wire therethrough, the wire guide including a second lumen laterally offset from and parallel to the first lumen, the second lumen being sized and shaped to slidably receive a guide wire therethrough.

7. The system of claim 6, wherein, The outer sleeve includes a first guide wire lumen extending longitudinally along the outer sleeve laterally outward of the conduit, the first guide wire lumen being for the purpose that a guide wire inserted through the first guide wire lumen enters a portion of a bone adjacent a distal end of the conduit when the insertion device is in the desired position to anchor the insertion device in the desired position.

8. The system of claim 7, wherein, The insertion device further includes a handle mounted to a proximal end of the outer sleeve, the handle including a second guide wire lumen extending through the handle, the second guide wire lumen being for the purpose that a guide wire inserted through the second guide wire lumen will enter a non-target bone when the device is in the desired position to secure the device to the non-target bone relative to a target portion of a bone.

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

10. The system of claim 8, wherein, The wire guide includes a distal end curved to form a blunt end to facilitate blunt dissection of tissue.

11. The system of claim 6, further comprising: A trocar sized and shaped for insertion through the catheter, the trocar including a distal end curved to form a blunt tip to facilitate blunt dissection of tissue when the trocar is inserted into the insertion device so that the blunt tip extends distally out of the outer sleeve.

12. The system of claim 10, wherein, The insertion device further includes an insertion device handle mounted to the proximal end of the outer sleeve, the insertion device handle including a recess configured to lockingly receive a proximal handle of the trocar, the length of the trocar selected so that when the proximal handle of the trocar is lockingly received within the insertion device handle, the blunt tip of the trocar is in a desired position extending distally out of the outer sleeve.

13. The system of claim 6, wherein, The insertion device further includes an insertion device handle mounted to the proximal end of the outer sleeve, wherein the inner sleeve includes a locking tab adjacent the proximal end of the inner sleeve, the system further including a locking ring received in 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 projection sized and positioned so that when the locking ring is positioned at a target position within the outer sleeve and the outer sleeve is mounted to the insertion device handle, the locking projection enters an opening at the locking tab to retain the inner sleeve at a desired position within the outer sleeve.

14. The system of claim 6, wherein, The inner sleeve includes a first adjustment opening extending along a portion of the length of the inner sleeve, 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 a diameter when opposite sides of the first adjustment opening are in contact with each other.

15. The system of claim 14, wherein, The inner sleeve is formed from 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 sized and positioned so that when the first and second members are in a desired position relative to each other, 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, thereby coupling the first and second members to each other, the first and second sliding tabs slidable within the respective adjustment openings transverse to the longitudinal axis of the inner sleeve.

16. The system of claim 15, wherein, Distal portions of the first and second members are bonded to each other, and proximal portions of the first and second members are not bonded to each other.

17. The system of claim 16, wherein, The distal portions of the first and second members are bonded to each other by welding.

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

Images