• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    suprapatellar insertion system, kit and method the present invention relates to a system (1) for inserting and securing, through the suprapatellar region (sr) of a leg, a pin (300) in a medullary channel (c) of a bone. the system may include a flexible sleeve (40) configured to be partially inserted into the leg. the flexible sleeve can define an anterior end (44) and an end end (42) spaced from the anterior end along a first axis (p1). the flexible sleeve can define a first cannulation (45) that extends along the first axis between the anterior and posterior ends. the first cannulation can be dimensioned to receive through it at least the intramedullary pin. the system may additionally include a retaining element (50) configured to support a portion of the flexible sleeve. the retaining element can be configured to position the flexible glove through the suprapatellar region of the leg so that the front end of the flexible glove is aligned with the back end of the bone. the intramedullary pin can be inserted through the flexible sleeve and into the medullary canal.
    公开号:BR112014016184B1
    申请号:R112014016184-4
    申请日:2012-12-28
    公开日:2021-04-27
    发明作者:Robert Limouze；Sean Powell
    申请人:Synthes Gmbh；
    IPC主号:
    专利说明:

    CROSS REFERENCE TO RELATED REQUESTS
    [001] This application claims priority over US patent application serial number 61 / 581,529, filed on December 29, 2011, entitled "Suprapatellar Kit and Method," which is incorporated herein by reference for all purposes, in its entirety. TECHNICAL FIELD
    [002] The present description is related to a system, kit and method for the insertion and fixation of a pin in a medullary canal of a bone. BACKGROUND
    [003] A pin can be inserted into a medullary canal of the bone to join the bone fragments of a tibia separated by a fracture. The intramedullary pin is inserted into the channel, so that the pin covers the fracture. Anchors can be inserted through the bone and into the intramedullary pin on opposite sides of the fracture, thereby fixing the intramedullary pin to the bone. The intramedullary pin can remain in the medullary canal at least until the fracture fuses. In an exemplary method, an intramedullary pin is inserted into the medullary canal of the tibia while the patient's knee is bent at a 90-degree angle. When the knee is bent 90 degrees during pin insertion, the quadriceps muscle pulls the proximal bone fragment obliquely in relation to the distal bone fragment and poor alignment of the bone fragment can occur. Inserting the intramedullary pin while the patient's knee is bent at a 10 to 20 degree angle can reduce the risk of poor alignment of the bone fragment because the quadriceps muscle does not pull the proximal bone fragment from the bone to that extent compared to when the knee is bent at an angle of 90 degrees or more.
    [004] There is a need for an improved system, kit and method for inserting a pin into a bone, and the subsequent fixation of the intramedullary pin to the bone. SUMMARY
    [005] According to a modality of the present disclosure, a system is provided to insert and fix, through a suprapatellar region of a leg, a pin in a medullary canal of a bone. The system may include a flexible sleeve configured to be partially inserted into the leg. The flexible sleeve can define an anterior end and a posterior end spaced from the anterior end along a first axis. The flexible sleeve can define a first cannulation that extends along the first axis between the anterior and posterior ends. The first cannulation can be sized to receive at least the intramedullary pin through it. The system may additionally include a retaining element configured to support at least a portion of the flexible sleeve. The retaining element can be configured to position the flexible glove through the suprapatellar region of the leg so that the anterior end of the flexible glove is aligned with the posterior end of the bone. The intramedullary pin can be inserted through the flexible sleeve and into the medullary canal. BRIEF DESCRIPTION OF THE DRAWINGS
    [006] The aforementioned summary, as well as the following detailed description of a preferred modality, will be better understood when read in conjunction with the attached diagrammatic drawings. For the purpose of illustrating the present description, reference is made to the drawings. The scope of the description, however, is not limited to the specific instrumentalities presented in the drawings. In the drawings:
    [007] Figure 1 is a perspective view of a system used to insert an intramedullary pin into a medullary canal of a bone through a suprapatellar region of a leg, according to one embodiment of the present disclosure;
    [008] Figure 2A is a perspective view of a retention device used with the system shown in figure 1;
    [009] Figure 2B is a plan view of the holding device shown in figure 2A;
    [010] Figure 2C is a side view of the holding device shown in figure 2A;
    [011] Figures 3A and 3B are seen in perspective and in section, respectively, of a flexible glove used with the system shown in figure 1;
    [012] Figures 4A and 4B are seen in perspective and in section, respectively, of a rigid glove used with the system shown in figure 1;
    [013] Figure 5 is a perspective view of a trocar used with the system shown in Figure 1;
    [014] Figure 6A is a perspective view of a wire guide used with the system shown in figure 1;
    [015] Figure 6B is an end view of the wire guide shown in Figure 6A;
    [016] Figures 7A and 7B illustrate a retention device with a flexible sleeve with the rigid sleeve inserted in the flexible sleeve, according to an embodiment of the present disclosure;
    [017] Figure 8A is a perspective view of a system insertion device shown in figure 1;
    [018] Figure 8B is a sectional view of a system insertion device shown in figure 8A taken along lines 8B-8B.
    [019] Figure 9A is a perspective view of the insertion device shown in Figure 2A illustrating a connection device, a drive mechanism and a portion of an intramedullary pin;
    [020] Figure 9B is an enlarged partial perspective view of the insertion device and a proximal end of the intramedullary pin shown in figure 10A;
    [021] Figure 9C is a perspective view of an intramedullary pin shown in figure 9B;
    [022] Figure 10 is a perspective view of a device for directing the system shown in Figure 1;
    [023] Figures 11A and 11B are side and sectional views, respectively, of a guide sleeve used in the system shown in figure 1;
    [024] Figures 12A and 12B illustrate the right leg of a patient prepared to receive an intramedullary pin in the medullary canal of the bone according to an embodiment of the present disclosure;
    [025] Figure 13 illustrates an exemplary deflection element used to reduce a fracture in a tibia according to one embodiment of the present disclosure;
    [026] Figure 14 illustrates the retention device that supports the flexible sleeve, a rigid sleeve partially inside the flexible sleeve and a trocar partially inside the rigid sleeve, and positioned on the leg so that the tip of the trocar engages at the proximal end of the tibia, according to one modality of the present disclosure;
    [027] Figure 15 illustrates the retention device that supports the flexible glove, the rigid glove and a wire guide inserted in the rigid and flexible gloves, with a wire positioned on the wire guide, according to one embodiment of the present disclosure;
    [028] Figure 16 illustrates the retention device that supports the flexible glove and the rigid glove, with an additional wire coupling the retention device to the leg femur, with the rigid glove positioned to receive more instruments in it, according to a form of the present disclosure; and
    [029] Figure 17 is a perspective view that illustrates how the insertion device is used to insert an intramedullary pin through the flexible sleeve and into a medullary canal of a tibia according to one embodiment of the present disclosure. DETAILED DESCRIPTION
    [030] Referring generally to figures 1 and 7A, system 1 is configured to prepare a medullary channel C of a T bone in a leg, insert an intramedullary pin 300 (sometimes referred to in the present invention as a "pin ") in the medullary canal C when the knee is flexed up to between 10 and 20 degrees of flexion, as shown in figures 1 and 12, and subsequently fix the intramedullary pin 300 to the T bone. The T bone can define a proximal and an extreme end -distal distance away from the proximal end along a TB1 axis. An upper-lower direction S1 of the first direction extends along the axis TB1. The femur F can have an axis of the femur F1 and the degree of flexion is defined by the angle formed by the axis of the femur F1 and the axis of the bone TB1. System 1 may include a retention device 50 (figures 2A-2C) and at least one flexible protective sleeve 40 (figures 7A and 7B) supported by the retention device 50 so that at least one flexible protective sleeve can be inserted through a suprapatellar SR region (figure 12B) of the leg. The suprapatellar region SR, as used here, means the region on the leg that is generally cranial to the patella P. Additionally, a rigid glove 30 can be at least partially placed on the flexible protective glove 40. The rigid glove 30 is configured to receive in it the instrumentation of preparation of the channel, for example, a portion of a trocar 80, a drilling set and a hole punch. A wire guide 90 (figure 6A) can also be placed at least partially inside the rigid sleeve 30 and is used to guide one or more wires 106 towards the T bone (figure 15). The wire 106 can guide the channel preparation instrumentation towards the T bone, as further detailed below. The flexible sleeve 40 can flex as needed to accommodate curved portions of the pin 300. In addition, the flexible sleeve 40 is configured to protect the fabric during the preparation stages of channel C and the insertion of the pin 300, while the rigid sleeve 30 can protect the flexible glove 40 from the instrumentation placed on the rigid glove 30.
    [031] Referring to figure 1, system 1 may also include an insertion device 10 connectable to the intramedullary pin 300 and additionally configured to advance the intramedullary pin 300 along the upper-lower direction S1 through at least one sleeve flexible guard 40 and into the medullary canal C, for example, when the rigid sleeve 30 has been removed from flexible sleeve 40. System 1 also includes a guiding device 200 configured to guide one or more anchors 8 into the bone T and the pin 300 along a transverse direction S2 or second direction that is generally transverse to the upper-lower direction S1. It should be understood that the transverse direction S2 can be any radially aligned direction that is transverse to the upper-lower direction S1. The steering device 200 is configured to support a guide sleeve 60 so that the guide sleeve 60 is positioned along the transverse direction S2 towards the bone T. Anchor 8 can be inserted through the guide sleeve 60 and fixed to the bone T, as shown in figure 1, and further detailed below. As will be understood, the guide sleeve 60 protects the tissue during the fixation phases of the intramedullary pin 300, as further described below.
    [032] System 1, as described here, can be used to insert the pin through the suprapatellar SR when the patient's knee is positioned in a flexion between about 10 to 20 degrees. The knee flexed to between 10 and 20 degrees during the insertion of pin 300 can minimize a possible poor alignment of the bone fragment compared to the procedure where the knee is positioned at a 90 degree flexion and the quadriceps muscles pull the bone fragment proximal obliquely. System 1, the kit and the method as described here can be used to stabilize fractures in the proximal tibia, distal tibia and tibial shaft, open and closed tibial shaft fractures, bad joints and non-tibial joints and certain pre-fractures and isthmic powders, for example.
    [033] System 1 may also include the preparation of the instrumentation used to facilitate the preparation of the medullary canal C for the suprapatellar insertion of a pin 300 therein. For example, the preparation instrumentation may include a drill assembly (not shown) with a cannulated drill positioned distally over the drill assembly, the cannulated drill being slidable along a guide wire 106 to prepare the C channel. A hole punch (not shown) can be used as needed to additionally prepare the spinal canal C to receive the intramedullary pin 300 therein, the hole being cannulated so as to be slid along the wire 160 through the rigid sleeve 30 towards the bone canal C.
    [034] System 1 may also include the fixation and insertion instrumentation used to facilitate the insertion of the intramedullary pin 300 in channel C. For example, a cap and hammer assembly (not shown) can be used to advance the intramedullary pin 300 into channel C. When the intramedullary pin 300 is in position, a bone drilling assembly (not shown) can be arranged on the guide sleeve 60 to prepare the T bone to receive the anchor 8. When the bone drilling assembly bone is removed, the drive mechanism 70 and the anchor 8 can be inserted into the guide sleeve 60.
    [035] With reference to figures 2A-2C, 7A and 7B, the retention device 50 is configured to retain one or more gloves 30, 40 in it. In addition, the retention device 50 is configured to position the respective gloves at least partially on the leg, so that the instrumentation, for example, the trocar 80, the insertion device 10 and the pin 300 can be arranged through the gloves 30 and 40 as needed. As shown in figure 2A, the retention device 50 can include a retention member 540 supported, for example, by a cable 520. Retention member 540 is spaced from the cable 520 along an axis of the retention device R3 or the first axis of the retaining member R3. The 520 cable is configured to receive a user's hand ergonomically. For example, cable 520 is shown elongated along axis R3, but it should be understood that cable 520 can have any configuration, shape, geometry or include any additional device or structure that can be wielded by a user.
    [036] Continuing with figures 2A-2C, 7A and 7B, retaining member 540 is configured to retain at least flexible sleeve 40. As discussed above, rigid sleeve 30 can be inserted into the cannulation of flexible sleeve 45 (figures 7A and 7B). Retention member 540 is also configured to secure the retention device 50 in position on the patient's leg. The retaining member 540 defines a retaining body 542 connected to or, for example, integral with an intermediate body 510. The intermediate body 510 can define one or more holes 512 and 514 extending transversely along the axis R3 through of the intermediate body 510. The one or more holes 512, 514 are configured to receive a fixation wire 107 (figure 17) through which it can fix the retention device 50 in position in relation to the leg. As shown in figure 17, the fixation wire 107 can define a distal end 107d. The distal end 107d can be inserted through holes 512 or 514 to engage the femur F, so that the retention device 50 is fixed in the desired position with respect to the leg.
    [037] The retaining body 542 can also define an opening 560 sized to receive at least a portion of the flexible sleeve 40, and / or at least a portion of the rigid sleeve 30. The retaining body 542 defines a first surface 544 and a second surface 546 spaced from the first surface 544 along a transverse axis of the holding device R1. The body 542 further defines a wall 548 at least partially connecting and extending between the first and second surfaces 544 and 546 along the transverse axis of the retaining device R1. The retaining body 542 can also define a circumferential channel 580 placed in the opening 560 which is configured to receive a portion of flexible sleeve 40.
    [038] Retaining member 540 can include at least one locking member 570a, 570b (two are shown) configured to selectively lock and unlock flexible sleeve 40 and rigid sleeve 30 on the retainer 50. Wall 548 can define at least one internal cavity (not shown) to support locking member 571. Locking member 570 is shown positioned on wall 548 of retaining body 542. Locking member 570 defines a body of locking member 571 and a projection 574a, b functionally connected to body 571a, b and extending through the cavity of the wall along an axis of the lateral retention device R2, which is perpendicular to the axes R1 and R2. In one embodiment, body 571a is configured to tilt projection 574a at least partially into opening 560. When locking member 570a is pressed along axis R2, projection 574a retracts into wall 548 and the flexible sleeve 40 can be inserted into or pulled out of the channel 580. When the locking member 570 is released, the protrusion 574 is angled into the opening 580, so that the protrusion 574 can help prevent axial displacement of the flexible sleeve 40 along the R1 axis.
    [039] Retaining member 540 may include a movable locking device 590 configured to selectively block opening 560, which may prevent possible axial displacement along the axis R1 of the rigid sleeve 30, the flexible sleeve 40 and / or the trocar 80. The locking device 590 can define a base 594 supported, for example, by the retaining body 542. The locking device 590 can further include a locking member 592 rotationally coupled to the base 594, so that the locking member 592 it can move between a first position X shown in figures 2A and 2B, where opening 560 is unobstructed by locking member 592, and a second position Y (shown in dashed lines in figure 2C), where the locking member 592 at least partially obstructs the opening 560. The locking member 592 can additionally define a surface 592b that faces the retaining body 542. The locking member 592 is positioned on the base 594 so that the surface surface 592b is spaced away from the retaining body 542 along axis R1 by a distance BD. The distance BD is defined as the distance between the surface 592b of the locking member 592 and the surface 544 of the retaining body 542. The locking member 592 is spaced from the surface 544 of the retaining body 542 so that when the lock 592 rotates in the Q direction (figure 2A), at least a portion of lock member 592 is at least partially aligned along axis R1 with opening 560.
    [040] Although a rotary locking device 590 is shown in the figures and described above, the locking device is not limited to such a configuration. In alternative embodiments, for example, the locking device 590 can be configured as a sliding member disposed on the base 594 and spaced from the surface of the retaining body 544. In such an embodiment, the sliding member (not shown) is movable from a first position , in which access to opening 560 is unobstructed, to a second position where opening 560 is at least partially blocked by the sliding member. It should be understood that other locking devices, mechanisms and structures can also be used.
    [041] With reference to figures 3A and 3B, flexible sleeve 40 is configured to flex as needed to accommodate the insertion of pin 300 through it. Additionally, the flexible glove 40 is configured to protect the soft tissue, while the tibial pin 300 is inserted into the medullary canal C of the T bone. In addition, the flexible glove 40 is also configured to protect the soft tissue, while the medullary canal C is being prepared for the insertion of the intramodular pin 300 therein, for example, when a drill is placed on the flexible sleeve 40. The flexible sleeve 40 defines a rear end 42 and an anterior end 44 spaced from the rear end 42 along a longitudinal axis P1, and the body part 41 extending between the anterior and posterior ends 44, 42. The flexible sleeve 40 defines a longitudinal cannulation 45 that extends along the longitudinal axis P1 between the posterior and anterior ends 42, 44. The flexible sleeve defines an inner surface 49, which defines cannulation 45. The rear end 42 includes an outer edge 46 that has a first and second radial latches 47 and 48 arranged around the outer edge 46 in a diametrically opposite relationship. The channel of the retaining member 580 also defines diametrically opposed protrusions 586 and 588 (figure 2C). The first and second radial locks 47 and 48 can receive the opposite protrusions 586 and 588 (figure 2C). In the illustrated embodiment, the cross-sectional dimension of the outer edge 46 is greater than the cross-sectional dimension of any other portion of the body part 41. The flexible sleeve 40 has a length so that when it is positioned inside the knee K, the anterior end 42 may extend, but without entering or penetrating the proximal end of the bone.
    [042] The cannulation of the flexible sleeve 45 is dimensioned to receive at least the intramedullary pin 300 and the insertion element 11 in it. Specifically, cannulation 45 defines a dimension in cross section 410 extending transversely to axis P1 between opposite portions of the inner surface 49. When the intramedullary pin 300 is inserted through longitudinal cannulation 45, flexible sleeve 40 can bend or flex to accommodate any curved portion 12 of the intramedullary pin 300. Flexible sleeve 40 is configured to flex in order to change a shape of the first axis P1 from a first configuration to a second configuration, the second configuration being different from the first configuration. The first configuration can be the configuration of the first axis P1 and the flexible sleeve, as shown in figures 3A and 3B. The second configuration can be defined as when the axis P1 is curved, crimped, bent or twisted, for example, when the curved pin 300 is inserted in the cannulation of sleeve 45 of flexible sleeve 40.
    [043] The flexible glove 40 is formed of a soft, malleable and flexible material, so that the glove 40 can flex, bend and / or twist when changing from the first configuration to the second configuration. Defined in another way, the flexible sleeve 40 is designed to support, by flexion as needed, the inflexibilities of the preparation of the medullary canal C and also the insertion of the pin 300 in it. In one embodiment, the flexible sleeve 40 is produced from a thermoplastic elastomer. An exemplifying elastomer is an elastomer sold under the trademark Santoprene ™, by Exxon Mobil Corporation. Although an elastomer is preferred, other materials can also be used. For example, flexible sleeve 40 can be formed of any polymeric material, including one or more polymers, and / or copolymer, polymer blend, or a composition of polymers, copolymers, additives and / or fillers that produce a smooth material , flexible and malleable, still preserving the structural integrity in use.
    [044] Referring to figures 4A and 4B, a rigid sleeve 30 is shown which is configured to be at least partially inserted into the flexible sleeve 40. The rigid sleeve 30 defines a front end 31, a rear end 33 spaced from the end anterior 31 along an axis P2 and a stem 34 extending between the anterior and posterior ends 31, 33. The rigid sleeve 30 defines a longitudinal cannulation 35 that extends along the axis P2 through the stem 34 and between the anterior and posterior ends 31, 33. The longitudinal cannulation 35 is sized to receive at least a portion of a trocar 80 and / or the wire guide 90, as described above. Additionally, cannulation 35 is sized to receive at least a portion of the drill (not shown) and the hole punch (not shown). Rigid sleeve 30 is elongated with a selected suprapatellar insertion length. The stem 34 defines an outer surface 131 and the opposite inner surface 133. Additionally, the stem 34 defines a cross-sectional dimension of the rigid sleeve 130 extending transversely to the axis P1 between the opposite portions of the outer surface of the stem 131. The dimension in cross-section of the rigid sleeve 130 is less than or approximately equal to the cross-sectional dimension of the cannula of the flexible sleeve 410, so that the stem 34 can be inserted in the cannulation of the flexible sleeve 45. Additionally, the cannulation 35 defines the cross-sectional dimension of the cannulation of the rigid glove 132 that extends transversely to the axis P1 between the opposite portions of the inner surface 133. The rigid glove 30 has a length so as to extend from at least one incision site 104 (figure 12B) to the proximal TP surface of the proximal tibia. The rigid sleeve 30 can be formed of steel, stainless steel, stainless steel and / or metal alloy or any other durable, rigid and biocompatible material. Rigid sleeve 30 protects flexible sleeve 40 during the drilling and boring operations discussed below.
    [045] The rigid sleeve 30 further defines an engagement element 36 located at the rear end 33 of the sleeve 30 and configured to engage the retention device 50. The engagement element 36 can define an engagement body 38 with a ridge 39 projecting radially outwardly from the stem 34 in a direction that is transverse to the axis P2, and at least one finger 32 (a pair of fingers is shown 32) extending radially outwardly from the engagement body 38. As illustrated, a cross-sectional dimension of the engaging element 36 that extends along a cross-sectional direction to the axis of the rigid sleeve P2 is greater than the cross-sectional dimension of the rod 34 and the distal end 31 of the rigid protective sleeve 30 , so that when the rigid glove 30 is inserted into the flexible glove 40, the crest 39 is contiguous with a portion of the flexible glove 40, preventing further advancement of the rigid glove 30 through cannulation of the flexible glove 45. The at least one finger 32 allows a user remove the rigid sleeve 30 from the sleeve 40 by grasping the finger 32 and pulling the rigid sleeve 30 out of the flexible sleeve 40. Additionally, the engagement body 38 can define at least one recess 37a, 37b which is configured to engage a portion of the retention device 50. Specifically, the recesses 37a and 37b are configured to receive the corresponding projections 574a, 574b of the locking members 570a and 570b (figures 2A-2C). When the locking members 570a and 570b are pressed by the user along the axis R2, the projections 574a, 574b are retracted into the wall 548, and the rigid sleeve 30 can be inserted into the cannulation of the flexible sleeve 45 up to the engagement 36 be partially placed within the opening of the retaining member 560, as shown in Figure 8A. When the locking members 570a and 570b are released, the respective projections 574a and 574b are forced by the wall 548 into the opening 580 along the axis R2 and into the engagement with the recesses of the engagement element 37a and 37b, respectively, additionally locking the rigid sleeve 30 in position.
    [046] Turning to figure 5, trocar 80 is configured to be at least partially placed in rigid sleeve 30. When trochate 80 is inserted into rigid sleeve 30, trocar 80 and gloves 30 and 40 can supported by the retention device 50 for positioning on the leg. The trocar 80 can be used to displace the soft tissue within the SR suprapatellar region. The trocar 80 defines a posterior end 81, an anterior end 83 spaced from the posterior end 81 along an axis of the trocar T1 and a stem 86 disposed between the posterior and anterior ends 81 and 83, respectively. The trocar 80 further defines a coupling element for the trocar 84 at the rear end of the trocar 81 and a tapered tip 82 at the anterior end of the trocar 83. The tip 82 and the stem 86 are dimensioned for the sliding engagement within the cannulation 35 of the rigid sleeve 30, so that the tip 82 protrudes from the main ends 44 and 31 of the respective sleeves 40 and 30. The stem 86 defines an external surface 181. Additionally, the stem 86 defines a cross-sectional dimension of the rigid sleeve 186 extending transversely to the T1 axis and between the opposite portions of the external surface 181. The cross-sectional dimension of the trocar stem 186 is less than or approximately equal to the cross-sectional dimension of the cannulation of the rigid sleeve 332, so that the stem 86 can be inserted in the cannulation of the rigid sleeve 35. Consequently, trocar 80 is configured for insertion in the cannulation 35 of the rigid sleeve 30, so that the tip 82 protrudes from the front end 31 of the sleeve rigid va 30 and the front end 44 of the flexible sleeve 40. Although the illustrated system 1 shows the trocar 80 inserted directly into the rigid sleeve 30, in other embodiments, the trocar 80 can be at least partially inserted directly into the cannulation 45 of the sleeve flexible 40.
    [047] The engaging element 84 of the trocar 80 is configured to engage at least a portion of the rigid sleeve 30 and / or the retaining device 50. The engaging element 84 may include a body 85 that forms a ridge 88 projecting radially out of stem 86 in a direction that is transverse to axis T1. When the trocar 80 is inserted into the rigid sleeve 30, the crest 88 is in contiguity with the coupling element 36 of the rigid sleeve 30, thus avoiding the further advance of the trocar 80 along the cannulation of the sleeve 35. Consequently, the dimension in section cross section of the enlarged member 84 is greater than the cross-sectional dimension of the stem 86 and the tip 82. The body 85 additionally defines a channel 87 circumferentially placed around the body 85, and is configured to facilitate manual manipulation by the surgeon. It should be understood that the body 85 can also define multiple grooves, grooves, holes, markers or protrusions, as needed.
    [048] The tip of the trocar 82 is configured to displace the soft tissue in the area around and between the proximal bone TP and the patella P. It should be understood that the tip 82 can have any shape, geometry or include an additional structure or device that could displace the soft tissue inside the knee. For example, tip 82 may define a curved end, such as a hemispherical cap similar to that shown in figure 7. In other embodiments, the tip of trocar 82 may be wedge-shaped. In addition, the degree of tapering along tip 82 may vary as needed.
    [049] The trocar 80 can be formed from any bio-compatible material, such as a polymeric material, metal and / or alloy materials, as needed. In a preferred embodiment, trocar 80 can be formed from polyether ether ketone (PEEK). However, system 1 is not limited to the PEEK trocar.
    [050] Referring to figures 6A and 6B, the wire guide 90 is configured to be at least partially placed in the rigid sleeve 30. The wire guide 90 is also additionally configured to guide one or more wires 106a, 106b ( figure 15) towards a desired anatomical location when the wire guide 90 is arranged with gloves 30, 40 and gloves 30, 40 are supported by the retention device 50 partially inside the leg. The wire guide 90 is configured to guide a first wire 106a towards a first anatomical site, for example, the site at the proximal end of the T bone, where the C channel must form. If necessary, a second wire 106b can be guided towards a more desirable second anatomical site, while the wire guide 90 is arranged on the rigid sleeve 30 and the first wire 106a remains on the wire guide 90.
    [051] Continuing with figures 6A and 6B, the wire guide 90 defines a proximal end 95 and a distal end 93 spaced from the proximal end 95 along an axis of the wire guide W1. The wire guide 90 can also define an elongated stem 94 extending between the opposite proximal and distal ends 93 and 95 along the axis of the wire guide W1. The proximal end 95 of the wire guide 90 defines an enlarged member 96 configured to engage a portion of the rigid sleeve 30 when the wire guide 90 is partially arranged within the rigid sleeve 30. The distal end 93 of the wire guide 90 can define a tip 91. The stem 94 and the tip 91 are dimensioned to be received in a sliding way in the rigid sleeve cannulation 35, while the extended member body 98 engages in the rear end 33 of the rigid sleeve 30, avoiding the further advance of the guide of wire 90 through rigid sleeve cannulation 35. The wire guide rod 94 defines an outer surface 191. The rod 94 further defines a dimension in cross section 194 that extends between the opposite portions of the outer surface of the rod 191 and along a transverse direction of the wire WT that is transverse to the axis W1. The cross-sectional dimension of the wire guide 194 is less than or approximately equal to the cross-sectional dimension of the rigid sleeve cannulation 132. The wire guide is thus configured to be slidably received in the rigid sleeve cannulation 45 .
    [052] The widened member 96 defines a body 98 including a ridge 98a that protrudes radially outwardly from the rod 94 inward along the transverse direction of the wire WT. When the wire guide 90 is inserted into the rigid sleeve 30, the ridge 98a may be in a boundary position with the engaging element 36 of the rigid sleeve 30. The extended member body 98 can define the handle portions 94 that facilitate manipulation by the surgeon, for example, to rotate the wire guide 90 into the rigid sleeve 30 so as to reposition the wires 106 as needed.
    [053] The enlarged member body 98 can also define the first and second holes 91 and 92, each of which is configured to receive the wires 106a or 106b (figure 15) therein. Each hole 91 and 92 can define a dimension in cross section that extends along a transverse direction of the wire WT. Yarns 106a and 106b can define a cross-sectional dimension of the yarn. The cross-sectional dimensions of holes 91 and 92 are larger than the cross-sectional dimensions of wires 106a and 106b. The first hole 91 is disposed along the radial center C of the wire guide 90 and extends along the axis of the wire guide W1 towards the distal end 93. The tip 91 can define a first outlet portion of the hole 92e . The second hole 92 is laterally displaced at a distance LD from the first hole 91. The wire guide rod 94 can define a groove 92g (figure 6A) that extends along the rod 94 towards tip 91, and a bridge portion 97 covering groove 92g along the transverse direction WT. The second orifice 92 extends through the widened limb body 98 and is in open communication with the groove 92g on the crest of the body 98a. Tip 91 can define an end of groove 92e.
    [054] Referring to figures 9B and 9C, a pin 300 may include a proximal end 302 and a distal end 304 away from proximal end 302 along a longitudinal direction L. The longitudinal direction L of the intramedullary pin 300 refers to to the length direction of the intramedullary pin 300. The intramedullary pin 300 defines an orifice of the pin 306 that extends at least partially between the ends of the proximal and distal pin along the longitudinal direction L. The intramedullary pin 300 also defines a plurality of openings 305 arranged at the distal and proximal ends of the intramedullary pin 300, respectively, and are configured to receive one or more anchors 8. The openings of the intramedullary pin 305a, 305b, 305c and 305d are positioned in different locations and orientations at the end proximal 302 of the intramedullary pin 300, so as to receive the anchors 8. The distal end 304 may have similar openings 305. The intramedullary pin 300 po to be elongated along the longitudinal direction L and can also define at least one curved portion 312 disposed between the proximal end 302 and the distal end 304. The curved portion 312 aligns the intramedullary pin 300 with the proximal tibia in relation to the tibial shaft and / or the distal tibia and tibial shaft. Pin 300 also defines a dimension in cross section 350 that extends transversely to the longitudinal direction L of pin 300. Pin 300 can define an external surface of pin 351. Pin 300 can also define at least one dimension in cross section 350 extending between the opposite portions of the outer surface of pin 351. The cross-sectional dimension of pin 350 is less than or approximately equal to the cross-sectional dimension of the cannulation of flexible sleeve 410. Pin 300 is thus configured to be received in the cannulation of flexible glove 45. It should be understood that the pin can have different dimensions of cross section, as illustrated in figure 9C. In alternative embodiments, the intramedullary pin 300 can be generically linear, as needed for the particular fracture in or position within the T bone. It should be understood that any pin 300 can be used as described here. Pins of different sizes 300 can be used according to the fracture site (s) and / or anatomical restrictions. For example, the intramedullary pin 300 can have one or more diameters, lengths and / or profiles selected, as needed.
    [055] Referring to figures 8A to 9B, the inserter 10 can include an inserter body 110, an inserter element 11 extending from the inserter body 110 along an axis of the insertion element A1, and a connecting arm 12 extending from insertion element 11 and configured to connect with guiding device 200. As shown in figure 2A, insertion element 11 defines a rear end 5, a anterior end 7 spaced from the posterior end 5 along the axis A1 and a cannulation 111 extending between the posterior and anterior ends 5 and 7 along the axis A1. The rear end 5 can define a cannulation portion of the front end 115. The front end 7 of the insertion element 11 can engage the intramedullary pin 300, as further detailed below and illustrated in figures 9A to 9C. The insert 11 defines an outer surface 112 and an inner surface 113 that defines the cannulation 111. The insert 11 also defines a cross-sectional dimension 150 that extends between the opposite portions of the outer surface of the insert 112 and is transversal to the A1 axis. The cross-sectional dimension of the insertion element 150 is less than or approximately equal to the cross-sectional dimension of the cannulation of the flexible sleeve 410. The insertion element 11 also defines a cross-sectional dimension of the cannulation 152 that extends between the opposing portions from the internal surface of the insertion element 113 and is transversal to the axis A1. The insertion element 11 is thus configured to enter the cannulation 45 of the flexible sleeve 40. The body of the insertion device 110 also defines a secondary orifice 107 which is offset from the axis A1. Secondary orifice 107 is configured to receive at least part of the cap and hammer assembly (not shown) that can be used to advance the intramedullary pin 300 along the upper-lower direction S1. The insert 11 can include the markings 117. The markings 117 on the insert 11 can be used to guide the insertion depth of the intramedullary pin 300 in channel C. The markings 117 are spaced a certain distance from each other and also from the anterior end 5 of element 11, so that the depth of insertion of the intramedullary pin can be measured with reference to the position of the markings 17. The markings 117 can be radiographic and visible by means of image analysis.
    [056] Turning to figure 9A, a connection device 15 can be used to connect the insertion device 10 to the pin 300. The connection device 15, for example, an elongated rod 21, defines an end proximal 19 and a distal end 18 spaced from a proximal end 19 along an axis of connection device A2. The distal end 18 can define a latching tip 16 configured to engage the intramedullary pin 300. The stem 21 and the distal end 18 are sized to be received in a sliding manner by the cannulation of the insertion element 111. The stem 21 can also define a longitudinal orifice 21b extending along the axis A2 between the proximal 19 and distal ends 19 and 18 respectively. When the connecting device 15 is arranged in the cannulation of the insertion element 111, the distal end 18 of the connecting device 15 protrudes from the front end 7 of the insertion element 11 to engage the hole in the intramedullary pin 306. The hole in the intramedullary pin 306 also defines the internal threads 310 (figure 9B). The coupling tip 16, which, for example, is threaded, is configured to match the internal threads 310 of the orifice of the intramedullary pin 306, in order to connect the intramedullary pin 300 and the insertion device 10. The proximal end 19 of the connecting device defines a socket 17, for example, a hexagonal socket. A drive mechanism 20 can be used to secure the connection device 15 to the intramedullary pin 300. The drive mechanism can define a distal tip 21a configured to engage socket 17 of the connection device 15. To rotate the connection device 15, the surgeon can insert the tip 21a of a drive 20 into socket 17 and then turn drive 20 to threadably secure device 20 to intramedullary pin 300. It should be understood that socket 17 can have any configuration which can operationally receive a distal end of a drive mechanism 20.
    [057] As shown in figures 9A and 9B, the distal end 7 of the insertion element 11 is configured to engage the insert pin 300. The distal end 7 of the insertion element 11 defines a projecting flap 9. A proximal end 302 of the prong 300 defines at least one notch 308 (figure 9B). When the insertion element 11 is arranged on the intramedullary pin 300, the projecting tab 9 is received inside the notch 8 in order to rotate the insertion device 10 in relation to the intramedullary pin 300. During use, the surgeon you can insert the tab 9 of the insertion device 10 into the slot 308. Then, the surgeon can insert the connection device 15 into the cannulation 111 of the insertion element 11. Then, the connection device 15 is rotated (via the drive 20) in relation to the insertion element 11, so that the threaded tip 16 corresponds to the internal threads 310 of the orifice of the intramedullary pin 306, thus coupling the intramedullary pin 300 to the insertion device 10.
    [058] Now with reference to figures 8A to 9A, the connecting arm 12 is configured to connect to the guiding device 200. The connecting arm 12 defines a body part 12b and a connecting member 12a spaced from the body part 12b along the A1 axis. The connecting arm 12 is displaced with respect to the insertion element 11, so that the connecting element 12a is spaced from the distal end 7 of the insertion element 11 along a direction S3 that is transversal to the axis A1. The direction S3 can be the same as the transverse direction S2 when the insertion device 10 is attached to the directing device 200. The connecting member 12a defines one or more (at least two 13a, 13b) alignment holes 13, and a hole internally threaded 14. The alignment holes 13a, 13b and the threaded hole 14 are configured to receive portions of the steering device 200. When the insertion device 10 is 1) positioned so that the intramedullary pin 300 is disposed in the medullary channel C, and 2) the insertion device 10 is connected to the directing device 200 by the connecting arm 12a, the directing device 200 is aligned with respect to the intramedullary pin 300 so that an anchor 8 is insertable in one of the pin openings intramedullary 305.
    [059] With reference to figure 10, the steering device 200 can include a steering element 210 configured to guide at least one anchor towards the T bone and pin 300, and a connecting element 220 configured to connect to the inserter 10. The guiding element 210 defines a guiding body 230 which is configured to support at least one guide sleeve 60, whereby the guide sleeve 60 is configured to guide anchors 8 towards the intramedullary pin 300. The guiding element 210 can support, for example, fixedly supporting, a plurality of extension members 242, 244 and 246 extending perpendicularly to the guiding body 230. The extensions are configured to guide the anchors into the bone T and the pin 300.
    [060] In the illustrated embodiment, the steering body 230 defines a position between a first end 231a and a second end 231b spaced from the first end 231a along a first transverse axis B1, and an apex portion 238 positioned between the first and the second ends. The steering body 230 can define a region R in which a portion of the patient's leg is received. The region R can be defined along the first transverse axis B1, which is perpendicular to a second transverse axis B2, which generally extends from the apex portion 238 to the inside of the patient's leg, when the system is positioned on the patient, and a third transverse axis B3 that extends along the upper-lower direction SR and is perpendicular to the first and second transverse axes B1 and B2. The steering body 230 defines an upper side 232 and a lower side 234 spaced from the upper side 232 along the third axis B3. The guiding body further defines an outer wall 235 extending between the upper and lower sides 232, 234, and an inner wall 236 configured to face the leg and extending between the upper and lower sides 232, 234. The extension members 242, 244 and 246 extend from the guiding body 230 along axis B3. In the modality shown in figure 10, extensions 242, 244 and 246 protrude from the lower surface 234 of body 230. In alternative modalities, extensions 242, 244 and 246 can protrude from or be attached to any side or portion of the guiding body 230.
    [061] The guiding body 230 defines a plurality of channels 251a-h configured to at least partially receive and support a guide sleeve 60 (figure 1), at least one anchor 8, a drilling set or a drive mechanism 70 As shown in figure 10, channels 251c and 251f are placed on the steering body 230, channels 251a and 251b are placed on extension member 242, channels 251d and 251e are placed on extension member 246 and channels 251g and 251h are placed on the extension member 244. Each of a plurality of channels 251 extends through the guiding body 230 along a transverse direction S2 and forms a passage through which the guide sleeve 60 can be inserted through it. According to the illustrated modality, the internal surface (not numbered) of each channel 251 is configured to receive, in a sliding way, the guide sleeve 60 (figure 10). Specifically, each channel 251 is configured so that when 1) the guiding device 200 is attached to the insertion device 10, and 2) the pin 300 is positioned in channel C, at least one channel 251 is aligned with a direction which is transversal to the intramedullary pin 300 and aligned with an opening 305 in the intramedullary pin 300. In addition, each channel 251 can be configured so that the guide sleeve 60 is manipulated inside the channel 251, in order to align the distal end 61 of the guide sleeve 60 with the appropriate pin opening 305. One or more of the channels 251 can define the elongated inlet 257 and the output portions 256 when the channels are very close together, to allow for the forced positioning of the instrumentation, such as the guide sleeve 60 and / or anchor 8. For example, channel 251b can define an elongated outlet portion 256 facing the R region, which allows the forced positioning of a guide sleeve 60 and anchor 8. Channel 251b is a pole tapered or tapered from outlet portion 257 toward the opposite inlet portion (not shown) along axis B1. The configurations of the channel 251b and the outlet portion 257 allow the controlled displacement of bone fragments, provide the juxtaposition and the juxtaposition under the patient's weight bearing. Additionally, channel 251h may include an elongated inlet portion 257 configured to allow for forced positioning of the instrumentation thereon. Channel 251h is polarized or tapered from inlet portion 257 towards the opposite outlet portion (not shown) along axis B1.
    [062] Although the steering body 230 and the extensions 242, 244 and 246 are separately described above, in alternative modalities, the steering body 230 and one or more of the extensions 242, 244 and 246 can be integrally formed. In addition, the steering body 240, for example, can be a curved frame configured to support a guide sleeve. In still other embodiments, the curved frame is configured to support one or more extension members 242, 244 and 246, and the connecting element 220, the extension members being configured to support the guide sleeve 60.
    [063] Continuing with figure 10, the connecting element 220 is configured to connect the directing device 200 to the insertion device 10. The connecting element 220 includes a fixing body 260, at least one (a pair 25 is shown) alignment pin 25 and a fixture 270, the alignment pin 25 and the fixture portion extending from the fixing body 260 along axis B2. The clamping body 260 defines a hole (not numbered) that is sized to receive a portion of the clamping device 270. The alignment pins 25a and 25b are configured to be inserted into the corresponding alignment holes 13a and 13b of the connecting member 12a (figure 1). The clamping device 270 defines a button coupled to an externally threaded stem 28 with a free end 29 that extends through the clamping body 260. The free end 29 of the threaded stem 28 can extend into and through a hole of the fixing body (not numbered) to match the corresponding threaded hole 14 in the connecting member 12a. The steering device 200 can be connected to the insertion device 10 by inserting the threaded rod 28 into the threaded hole 14, during the positioning of the alignment pins 25 in the alignment holes 13 of the connecting member 12a. The button 270 can be rotated so that the threads of the stem 28 coincide with and engage with the internal threads of the hole 14, thus securing the fastening body 260 to the connecting member 12a. It is to be understood that the position of the pin 300, the insertion device 10 and the directing device 200 can be manipulated as necessary to facilitate alignment. For example, the surgeon can, by means of radiographic image analysis, confirm the position of the intramedullary pin 300 in the tibial C channel.
    [064] Although the button assembly 270 and threaded rod 28 is shown, other safety devices can be used to attach the steering device 200 to the insertion device 10. In an alternative embodiment, the fixation device can be a jaw assembly configured to grip the fastening body 260 to the connecting member 12a. In other alternative embodiments, the clamping device 25 can also be an interlocking device that connects by means of pressure clamping the clamping body 260 and the connecting member 12a. Additionally, in other exemplary embodiments, the fastening body 260 can be a cylindrical body with an internally threaded hole, while the connecting member 12a has externally arranged threads configured to engage the threaded hole. Such a configuration can couple the connecting member 12a to the fixing body 260, thus connecting the insertion device 10 to the directing device 200. In any of the alternative modalities described above, provision can be made to ensure proper alignment of the insertion device. 10 in relation to the guiding device 200, such as alignment pins, pins or alignment holders, alignment screens and visual indicators (for example, color coding) to indicate proper alignment.
    [065] Now with reference to figures 11A and 11B, the guide sleeve 60 is configured to guide at least one anchor towards the intra-medullary pin 300 when the guide sleeve 60 is supported by the guiding device 200. The guide sleeve 60 includes a distal end 62, a proximal end 64 distanced from the distal end 62 along an axis G1 and a rod 66 extending between the opposite ends proximal 64 and distal 62 and along the axis G1. The rod 66 defines a cannulation of the guide sleeve 69 which extends along the axis G1. The distal end 62 can be tapered. The proximal end 64 includes an engagement element 65 that forms a ridge 68 extending from the stem 66 along a direction that is perpendicular to the axis G1. The ridge 68 is configured to be in a borderline position with an external surface of the guiding element 210 when the guide sleeve 60 is supported by the channel 251. It should be understood that when 1) the intramedullary pin 300 is disposed in the medullary channel C, 2) the guiding device 200 is connected to the insertion device 10, and 3) the guide sleeve 60 is supported by the guiding device 200, the anchor 8 is insertable through the guide sleeve 60 into the engagement with the bone T and into the corresponding opening 305 in the intramedullary pin 300.
    [066] When the anchor is inserted through the guide sleeve 60, a drive mechanism can be used to secure the anchor 8 to the intramedullary pin 300 and the T bone. The drive mechanism 70 may include the distal end distant from the cable along of a portion of the stem. The portions of the distal end and the stem can be inserted through the cannulation of the guide sleeve 69, so that the distal end of the drive mechanism engages the anchor 8. The drive mechanism 70 can rotate in order to fix the anchor 8 in the opening 305 of the intramedullary pin 300 and the T bone. It should be understood that other instrumentation can be inserted into the guide sleeve 60 as needed. For example, a trocar can be inserted through the guide sleeve 60 to displace the soft tissue adjacent to the cortex of the T bone. A portion of a bone drilling set can be inserted through the cannulation of the guide sleeve 69 to pierce an opening in the bone to provide access to the 300 intramedullary pin. One or more protective gloves can be inserted into the cannulation of the guide glove 69.
    [067] The system may also include an extraction member (not shown) configured to be less partially inserted in cannulation 111 of the insertion element 11 for operable connection with the intramedullary pin 300 placed in the medullary canal C. The extraction member can be connected to the intramedullary pin 300, locked in position and then pulled in an upper direction A in order to remove the intramedullary pin 300 from the T bone.
    [068] Referring in general to figures 1 and 12 to 17, system 1 can be used to implant a pin 300 in a medullary channel C of the T bone. The suprapatellar insertion, as discussed above, is the insertion of the intramedullary pin 300 through a suprapatellar SR region of the leg, as shown in Figure 12A. To prepare the suprapatellar insertion and the subsequent fixation of the intramedullary pin 300 to the T bone, the patient is placed supine on a radiolucent table. When placing the patient on the radiation-transparent table, the knee K of the injured leg can be positioned on top of a knee roller 101 to ensure that the knee K of the injured leg can be bent between an angle θ1 equal to about zero ( 0) degrees (total extension), and a bending angle θ2 that is between about 10 to 20 degrees. The angles θ1 and θ2 are defined between an axis of the femur F1 and an axis of the tibia TB1, as shown in figure 12A. During certain stages of the method, as disclosed in the present invention, the injured leg is positioned in full extension to define an angle θ1 of about 0 (zero) degrees, while in other stages the knee K is flexed. The leg can define an upper direction A and a lower direction I. Directions A and I align with the direction S1 discussed above.
    [069] Turning to figure 13, fracture 950 can initially be reduced to restore the fractured bone to its correct alignment. A deflection element 900 shown in Figure 13 can be used to reduce the fracture, although any suitable deflection element can be used. The deflection element 900 can include two rods with spaced parts 925 and 935 positioned on the T bone on opposite sides of the fracture 950. The rods can be attached to the respective clamps 920 and 930, and the spacing between the clamps 920 and 930, shape the rods 925 and 935 are lowered or raised as needed.
    [070] The surgeon can determine and identify the appropriate pin length 300 after fracture reduction 950. In one embodiment, the surgeon can use a scanning rule (not shown) that can be placed along the injured leg parallel to the T bone The scanning rule is adjusted until its distal tip is at the level of the physical scar or the desired pin insertion depth. The surgeon then takes a radiographic image of the tibia and the ruler. The length of the intramedullary pin can be read directly from the image of the ruler, selecting the measurement at or just below the level of the anterior edge of the tibial plateau.
    [071] Next, the knee K can be positioned at or almost in full extension (θ1 ~ zero degrees) while incisions 104 are made in the suprapatellar region SR, as shown in figure 12B. Incision 104 can be made closer or further from the patella P, as needed, depending on anatomical or other indications. A deep longitudinal incision (not shown) is made to divide the quadriceps tendon in half, just above its insertion in the P patella.
    [072] After the reduction and incision steps, the method generally proceeds by preparing, then, the medullary canal C for insertion of the intramedullary pin 300 there, followed by the insertion and fixation of the intramedullary pin 300 to the T bone. after incision 104 is made, preparation set 105 is assembled and inserted through the incision towards the proximal tibia. Specifically, the flexible sleeve 40 is inserted and retained by the retention device 50, as described above. The locking members 570 on the retaining member 540, for example, can be pressed so as to allow the flexible sleeve 40 to fit into the opening 560 and to be received by the opening channel 580, as discussed above. Locking members 570 remained pressed to retract projections 574 into wall 548, and then rigid sleeve 30 is inserted into flexible sleeve 40. When locking members 570a and 570b are released, projections 574a and 574b engage the recesses 37a and 37b of the engagement member of the rigid sleeve 36 (figure 7A). Then, the trolley 80 is then positioned inside the rigid sleeve 30 so that the tip 83 and at least a portion of the shaft 86 (not shown) protrude from the main ends 44 and 31 of the flexible sleeve 40 and the rigid sleeve 30, respectively. As discussed above, the holding device 50 in this way holds rigid sleeve 30, flexible sleeve 40 and trolley 80 together. then, the locking member 590 can be placed in the locking position Y (figure 2C) to block the axial displacement along the axis R1 of the rigid sleeve 30 and the trocar 80.
    [073] Using the retention device 50, the flexible glove, the rigid glove 30 and the trocar 80 are inserted through the incision 104 and advances along a lower direction I between the articular surface of the patella P and the trochlea of the distal femur . However, neither the rigid glove 30 nor the flexible glove 40 penetrates the proximal portion of the T bone. During the insertion step of the set 105, the patella P is placed in an anterior position. With knee K extended, the set 105 advances towards the tibia until trocar 80 reaches the proximal surface of the tibia. As needed, the surgeon can reposition the 590 locking member as needed, unlocking the position. Then, trocar 80 is removed in an upper direction A from set 105 and the patient.
    [074] With reference to figure 14, then the wire guide 90 is inserted into the rigid sleeve 30. The wire guide 90 then advances towards the anterior surface of the tibia T along the lower direction I. At this point in the procedure, the K knee is flexed between 10 and 20 degrees to provide a radiographic location for a starting point and insertion of wires 106a and 106b. The wires can thus be aligned with the desired anatomical location. It is to be understood that the wires 106a, 106b can include a distal end 106d, and a proximal end 106p spaced from the distal end 160d. The first wire 106a is then inserted through the first hole 91 of the wire guide 90. The wire 106a then advances to access the T bone marrow channel C. A radiographic image is taken to check the position of the first wire 106a. If the wire 106a is positioned incorrectly, a second wire 106b can be inserted through the second hole 92, along the groove 92g towards the tip of the wire guide 91, while the first wire 106a remains in place at the first hole 92. The yarn guide 90 can then be rotated within the rigid sleeve 30 to the position of the second yarn 106b at the desired location. The first wire 106a can then be removed from the wire guide 90 if the second wire 106b is positioned properly. When wire 106a or 106b is in the desired position, the proximal end of wire 106p can be inserted through the cannulated drill to guide the cannulated drill towards the T bone to form channel C. The cannulated hole punch can be arranged along the wire 106, as needed. System 1 may include several guidewires configured for the appropriate surgical method, for example, the guidewires may have multiple cross-section dimensions and lengths, as needed, for the anatomy of the particular leg.
    [075] With reference to figure 15, the retention device 50 is subsequently anchored to maintain the position of the retention device 50 during the procedure. The fixation wire 107 is inserted through the transverse hole 512 in the intermediate body 510 of the retention device 50. The wire 107 advances until its distal tip 107d penetrates the femur of patient F. With the retention device 50 fixed in the relative position to the leg, a drill set is used to prepare channel C. The drill set can include the cannulated drill that can slide along wire 106. The drill can be placed over wire 106 and then advances through the rigid sleeve 30 until the drill reaches the T bone. The drill assembly is then used to open the spinal canal C. If necessary, a cannulated punch can slide along the wire 106 and be used to widen the spinal canal C. After opening the medullary canal C, the drill and the wire 106, the wire guide 90 and the rigid sleeve 30 are removed from the patient. With the medullary canal C prepared, the steps used to insert and secure the intramedullary pin 300 to the T bone will now be described.
    [076] The insertion device 10 can be coupled to the pin 300 as described above, with respect to figures 9A to 9C. The rigid glove 30 is removed from the retention device 50 and the flexible glove 40. Referring to figure 17, using the insertion device 10, the intramedullary pin 300 is inserted into the medullary channel C of the bone T through the flexible glove 40. If If necessary, a hammer and cap assembly can be placed in orifice 107 of body 110 and used to forcibly advance the intramedullary pin 300 into the medullary canal C. The proper position of the intramedullary pin 300 can be determined by using radiographic visualization to determining the location of the markings 117 at the front end 7 of the insert 11, as discussed above. In addition, the position of the distal end 304 in the medullary canal C can be determined using radiographic visualization, or other means.
    [077] With reference to figure 1, when the intramedullary pin 300 is properly positioned in the medullary canal C, the directing device 200 is connected to the insertion device 10. The alignment pins 25 are positioned inside the holes 13 of the limb. connection 12a, while the clamping device 27 fixes the clamping body 260 to the connecting member 12a, thereby aligning at least one channel 251 with at least one opening 305 of the pin 300. Preferably, one or more grooves 251 are aligned with one or more corresponding openings 305. A guide sleeve 60 can then be inserted through groove 251 of direction device 200, as shown in figure 1. Next, a portion of the bone drilling assembly is positioned inside cannulation 69 of guide sleeve 60. The drill set forms an opening in the T bone at a location close to the opening 305 aligned with the selected groove 251. The drill assembly is then removed that of the guide sleeve 60. Then, an anchor 8 is positioned at the distal end of the drive mechanism 70, and anchor 8 and the drive mechanism 70 are inserted in the cannulation 69 of the guide sleeve 60. The drive mechanism 70 is used to rotate anchor 8 so that anchor 8 engages opening 305 of intramedullary pin 300, thereby securing intramedullary pin 300 to bone T. Additional anchors 8 can be positioned and attached to intramedullary pin 300, as needed .
    [078] It should be noted that the illustrations and discussions of the modalities shown in the figures are for illustrative purposes only, and should not be considered as limiting the description. The person skilled in the art will realize that the present description contemplates several fashions. It should be further understood that the features and structures described and illustrated according to one modality can apply to all modalities as described here, except where otherwise indicated. Additionally, it should be understood that the concepts described above with the modalities described above can be used alone or in combination with any of the other modalities described above.
    权利要求:
    Claims (15)
    [0001]
    1. System (1) for inserting and securing, through a suprapatellar region (SR) of a leg, a pin (300) in a medullary channel (C) of a bone (T), the system (1) comprising: a flexible sleeve (40) configured to be partially inserted in the leg, the flexible sleeve (40) defining an anterior end (44) and a posterior end (42) spaced from the anterior end (44) along a first axis (P1), the flexible sleeve (40) defining a first cannulation (45) that extends along a first axis (P1) between the anterior and posterior ends (42, 44), the first cannulation (45) dimensioned to receive through it by the minus the intramedullary pin (300), where the flexible sleeve (40) is configured to flex in order to change a shape of the first axis (P1) from a first configuration to a second configuration, where the second configuration is different the first configuration; wherein the intramedullary pin (300) is insertable through the flexible sleeve (40) and into the medullary canal (C), characterized by the fact that the system (1) still comprises a retaining element (540) configured to support at least a portion of the flexible sleeve (40) on the leg, where the retaining element (540) is configured to position the flexible sleeve (40) through the suprapatellar region (SR) of the leg so that the front end (44) of the sleeve flexible (40) is aligned with a proximal end of the bone (T).
    [0002]
    2. System (1) according to claim 1, characterized by the fact that it still comprises the intramedullary pin (300), in which the intramedullary pin (300) defines a proximal end (302) and a distal end (304) , and at least one curved portion (312) that is arranged at least between the proximal and distal ends (302, 304) of the intramedullary pin (300), and the flexible sleeve (40) is configured to flex when the pin (300) it is inserted from the rear end (42) to the front end (44).
    [0003]
    System (1) according to claim 1 or 2, characterized in that the bone (T) defines a distal end (304) spaced from the proximal end (302) along a first direction (S1) , wherein the system (1) further comprises an insertion device (10) configured for removable connection to the intramedullary pin (300), in which the intramedullary pin (300) and at least a portion of the inserter (10) are configured to be received in the first cannulation (45) of the flexible sleeve (40), where when 1) the insertion device (10) is connected to the intramedullary pin (300), and 2) the flexible sleeve (40) is inserted at least partially in the leg, the insertion device (10) can advance the intramedullary pin (300) through the flexible sleeve (40) along the first direction (S1) to position the intramedullary pin (300) in the medullary canal (C).
    [0004]
    4. System (1), according to claim 3, characterized by the fact that it still comprises a guiding device (200) connectable to the insertion device (10), the guiding device (200) configured to guide at least one anchor (8) towards the bone (T), where when 1) the guiding device (200) is connected to the insertion device (10), and 2) the intramedullary pin (300) is positioned in the medullary canal (C) , the steering device (200) guides at least one anchor (8) towards the bone (T) along a second direction (S2) which is transversal to the first direction (S1).
    [0005]
    System (1) according to claim 4, characterized in that the insertion device (10) still comprises an insertion element (11) defining an anterior end (7) and a spaced rear end (5) from an anterior end (7) along a second axis (A1), the insertion element (11) defines an insertion element orifice (111) that extends between the anterior and posterior ends (7, 5) along of the second axis (A1), in which the insertion element (11) is configured to be at least partially arranged in the first cannulation (45) of the flexible sleeve (40).
    [0006]
    6. System (1), according to claim 5, characterized by the fact that the intramedullary pin (300) defines a pin orifice (306) extending at least partially between the proximal and distal ends (302, 304) to the along an intramedullary pin direction, and one or more openings (305), each configured to receive a portion of at least one anchor (8), and a connecting rod (21) configured to couple the insertion device (10) on the intramedullary pin (300), where the connecting rod (21) is configured to be at least partially arranged in the hole (111) of the insertion element (11), where when the connecting rod (21) is at least partially arranged in the hole (111) of the insertion element (11), a portion (16) of the connecting rod (21) engages at least a portion (310) of the intramedullary pin hole (306) to connect the pin (300) intramedullary to the insertion device (10).
    [0007]
    System (1) according to any one of claims 5 to 6, characterized in that the proximal end (302) of the intramedullary pin (300) defines a notch (308), and the anterior end (7 ) of the insertion element (11) defines a flap (9), in which the flap (9) is configured to be received by the notch (308) so as to pivot in the insertion element (11) relative to the pin (300) intramedullary.
    [0008]
    System (1) according to any one of claims 4 to 6, characterized in that the guiding device (200) comprises a guiding element (210), and in which the system (1) further comprises a guide sleeve (60) configured to be supported by the guiding element (210), wherein the guide sleeve (60) defines a proximal end (64), a distal end (62) spaced from a proximal end (64) along an axis of guide sleeve (G1), and a guide sleeve cannulation (69) extending between the proximal and distal ends (64, 62) along the guide sleeve axis (G1), where at least one anchor (8) is insertable through the cannulation of the guide sleeve (69), in which the guiding element (210) preferably defines a first surface (235), a second surface (236) spaced from the first surface (235) along the second direction and a plurality of channels (251) extending between the first and second surfaces (235, 236) along the second the direction, each channel (251) configured to at least partially receive the guide sleeve (60) in it.
    [0009]
    9. System (1), according to claim 8, characterized by the fact that the guiding element (210) is a structure that supports at least one extension element (242, 244, 246), the at least one element of extension extension (242, 244, 246) includes at least one of the plurality of channels (251), in which when the guiding element (210) is attached to the insertion device (10) 1) the structure partially surrounds a portion of the leg and 2) the at least one extension element (242, 244, 246) extends along the first direction.
    [0010]
    System (1) according to any one of claims 1 to 9, characterized in that the retaining element (540) comprises a retaining body (542) having a first surface (544) spaced from one another second surface (546) along a retaining element axis (R1), and an opening (560) extending between the first and second surfaces (544, 546) along the retaining element axis (R1), wherein the opening (560) is dimensioned to receive at least a portion of the flexible sleeve (40), where preferably the proximal end (42) of the flexible sleeve (40) defines an edge (46) having first and second holders (47 , 48), and where preferably the opening (560) defines the first and second protruding sections (574a, 574b) spaced apart, in which the first and second holders (47, 48) are configured to be received between the first and the second protrusion (574a, 574b) when the flexible sleeve (40) is positioned in the opening.
    [0011]
    System (1) according to any one of claims 1 to 10, characterized in that it still comprises a rigid glove (30) configured to be at least partially arranged in the first cannulation (45) of the flexible glove (40) , wherein the rigid sleeve (30) preferably defines an anterior end (31), a posterior end (33) spaced from the rear end (31) along a rigid sleeve axis (P2) and a rigid sleeve cannulation (35 ) extending between the anterior and posterior ends (31, 33) along the rigid sleeve axis (P2).
    [0012]
    12. System (1) according to claim 11, characterized by the fact that the rigid sleeve (30) includes an engaging element (36) disposed at the rear end (33) of the rigid sleeve (30), in which a portion of the engaging element (36) is configured to engage the retaining element (540) when the rigid sleeve (30) is arranged in the first cannulation (45) of the flexible sleeve (40).
    [0013]
    13. System (1) according to claim 12, characterized by the fact that the latching element (36) still defines at least one recess (37a, 37b), and by a finger (32) extending from the latching element engagement (36), and wherein the retaining element (540) comprises at least one movable locking element (570a, 570b), the at least one movable locking element (570a, 570b) includes a projection (574a, 574b) extending along a lateral direction that is perpendicular to the axis of the retaining element (R1), where the at least one movable locking element (570a, 570b) is configured to selectively move the movable projection (574a , 574b) along the lateral direction in and out of at least one recess (37a, 37b).
    [0014]
    14. System (1) according to any one of claims 11 to 13, characterized by the fact that it still comprises at least one wire guide (90) configured to be at least partially arranged in the cannulation of the rigid sleeve (35 ).
    [0015]
    15. System (1) according to claim 18, characterized in that the at least one wire guide (90) defines a proximal end (95), a distal end (93) spaced from the proximal end (95) along a wire guide axis (W1), and first and second holes (91, 92) extending at least partially along the wire guide axis (W1), where the first hole (91) is aligned with the wire guide axis (W1), and the second hole (92) is offset from the first hole (91), where the first hole (91) preferably extends along the wire guide axis (W1) in towards the proximal end (92) of the wire guide, and where the wire guide (90) preferably still defines a groove (92g) extends between the proximal and distal ends (95, 93) of the wire guide (90) , the groove (92g) aligned with the second hole (92).
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    法律状态:
    2018-12-04| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2020-02-04| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2021-03-23| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2021-04-27| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 28/12/2012, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    US201161581529P| true| 2011-12-29|2011-12-29|
    US61/581,529|2011-12-29|
    PCT/US2012/071987|WO2013102025A1|2011-12-29|2012-12-28|Suprapatellar insertion system, kit and method|
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