Any and all applications for which a foreign or domestic priority claim is identified in the Application Data Sheet as filed with the present application are hereby incorporated by reference under 37 CFR 1.57.
The field of the invention generally relates to medical devices for treating conditions involving the skeletal system and in particular bone fracture applications.
Distraction osteogenesis, also known as distraction callotasis and osteodistraction has been used successfully to lengthen long bones of the body. Typically, the bone, if not already fractured, is purposely fractured by means of a corticotomy, and the two segments of bone are gradually distracted apart, which allows new bone to form in the gap. If the distraction rate is too high, there is a risk of nonunion, if the rate is too low, there is a risk that the two segments will completely fuse to each other before the distraction period is complete. When the desired length of the bone is achieved using this process, the bone is allowed to consolidate. Distraction osteogenesis applications are mainly focused on the growth of the femur or tibia, but may also include the humerus, the jaw bone (micrognathia), or other bones. The reasons for lengthening or growing bones are multifold, the applications including, but not limited to: post osteosarcoma bone cancer, cosmetic lengthening (both legs—femur and/or tibia) in short stature or dwarfism/achondroplasia, lengthening of one limb to match the other (congenital, post-trauma, post-skeletal disorder, prosthetic knee joint), non-unions.
Distraction osteogenesis using external fixators has been done for many years, but the external fixator can be unwieldy for the patient. It can also be painful, and the patient is subject to the risk of pin track infections, joint stiffness, loss of appetite, depression, cartilage damage and other side effects. Having the external fixator in place also delays the beginning of rehabilitation.
In response to the shortcomings of external fixator distraction, intramedullary distraction nails have been surgically implanted which are contained entirely within the bone. Some are automatically lengthened via repeated rotation of the patient's limb. This can sometimes be painful to the patient, and can often proceed in an uncontrolled fashion. This therefore makes it difficult to follow the strict daily or weekly lengthening regime that avoids nonunion (if too fast) or early consolidation (if too slow). Lower limb distraction rates are on the order of one millimeter per day. Other intramedullary nails have been developed which have an implanted motor and are remotely controlled. The motorized intramedullary nails have an antenna which needs to be implanted subcutaneously, thus complicating the surgical procedure, and making it more invasive. These devices are therefore designed to be lengthened in a controlled manner, but due to their complexity, may not be manufacturable as an affordable product. Others have proposed intramedullary distractors containing and implanted magnet, which allows the distraction to be driven electromagnetically by an external stator (i.e., a large electromagnet). Because of the complexity and size of the external stator, this technology has not been reduced to a simple and cost-effective device that can be taken home, to allow patients to do daily lengthenings.
Fracture of long bones is often treated with trauma nails. These implants are placed intramedullary to hold the bones together. Often in cases of complex fracture having an irregular break geometry or having multiple bone fragments, it is difficult to secure the nail so that the bone is held at the correct length. Other times it is desired to hold the bone in a manner that apply compression. Every year in the United States, more than 90,000 tibia and femur shaft fractures are defined as complex. Many of these fractures are treated with trauma nails with varying results. Some of the possible complications from the treatment of these complex fractures include: infection, vascular injuries, non-union, neural injury, associated injuries to other bone or joint locations and heterotopic ossification. Also included in the possible complications is the possibility of unmatched bilateral bone lengths.
In one embodiment, a method for treating a complex fracture with a variable length nail comprising a housing and a distraction shaft, the housing containing a rotatable permanent magnet mechanically coupled to a lead screw, the lead screw interfacing with a nut such that rotation of the lead screw in a first direction causes the distraction shaft to axially retract within the housing and rotation of the lead screw in a second direction causes the distraction shaft to axially extend from the housing, wherein the nail is configured for at least 5 mm of axial length change in each direction. The method includes making a first hole or incision in the skin of the patient in proximity to a fractured long bone and at least partially clearing a canal through the center of the long bone and inserting the variable length nail into the canal and securing the housing and distraction shaft to separate portions of the fractured long bone. The hole or incision is caused or allowed to close and an external adjustment device is placed in proximity to the patient's skin. The external adjustment device includes at least one rotatable magnet. The external adjustment device is operated so that a magnetic field of the at least one rotatable magnet causes the rotatable permanent magnet of the variable length nail to rotate, causing the distraction shaft to either retract into or extend from the housing.
In another embodiment, a variable length nail system includes a nail that includes distraction shaft and a housing, the housing containing a rotatable permanent magnet mechanically coupled to a lead screw, the lead screw interfacing with a nut such that rotation of the lead screw in a first direction causes the distraction shaft to axially retract within the housing and rotation of the lead screw in a second direction causes the distraction shaft to axially extend from the housing, wherein the nail is configured for at least 5 mm of axial length change in each direction. The system further includes an external adjustment device that has at least one rotatable magnet, wherein the rotatable permanent magnet of the nail is configured to be rotated by a moving magnetic field of the at least one rotatable magnet of the external adjustment device, and wherein rotation of the at least one rotatable magnet of the external adjustment device in a first rotational direction retracts the distraction shaft into the housing and rotation of the at least one rotatable magnet of the external adjustment device in a second rotational direction, opposite of the first rotational direction, extends the distraction shaft from the housing.
Over the treatment period, the bone 100 is regularly distracted, creating a new separation 106, into which osteogenesis can occur. Regularly distracted is meant to indicate that distraction occurs on a regular or periodic basis which may be on the order of every day or every few days. An exemplary distraction rate is one millimeter per day although other distraction rates may be employed. That is to say, a typical distraction regimen may include a daily increase in the length of the intramedullary lengthening device 110 by about one millimeter. This may be done, for example, by four lengthening periods per day, each having 0.25 mm of lengthening. The intramedullary lengthening device 110, as disclosed in more detail below, has a magnetic drive system, which allows the distraction shaft 114 to be telescopically extended from the housing 112, thus forcing the first section 102 and the second section 104 of the bone 100 apart from one another. As the distraction process is performed, a portion of the housing 112 is able to slide within the hole or bore 108 of the first section 102 if the housing 112 is located within a displacement section 120 as illustrated in
Turning to
Cylindrical magnet 134 is fixedly contained within a magnet casing 158 using, for example, an adhesive such as an epoxy. The magnet casing 158 and cylindrical magnet 134 contained therein rotate relative to the stationary magnet housing 128. The cylindrical magnet 134 may be a rare earth magnet such as Nd—Fe—B and may be coated with Parylene or other protective coatings in addition to being protected within the magnet casing 158, for example hermetically potted with epoxy. The magnet casing 158 contains an axle 160 on one end thereof which attaches to the interior of a radial bearing 132. The outer diameter of the radial bearing 132 is secured to the interior of the end cap 130. This arrangement allows the cylindrical magnet 134 to rotate with minimal torsional resistance. At its other, opposing end, the magnet housing 158 includes an axle 161, which is mechanically coupled to a first planetary gear set 154. The axle 161 includes the sun gear of the first planetary gear set 154, the sun gear turning the planetary gears of the first planetary gear set 154. The first planetary gear set 154 serves to reduce the rotational speed and increase the resultant torque delivery from the cylindrical magnet 134 to the lead screw 136. A second planetary gear set 156 is also illustrated mechanically interposed between the first planetary gear set 154 and the lead screw 136, for further speed reduction and torque augmentation. The number of planetary gear sets and/or the number of teeth in the gears may be adjusted, in order to achieve the desired speed and torque delivery. For example, a lead screw 136 with eighty (80) threads per inch attached to two planetary gear sets of 4:1 gear ratio each inside a 9 mm device with magnet location in the distal femur can achieve at least 100 lb. of distraction force at a greater than average distance or gap from the external device (
The thrust bearing 138 serves to protect the magnet/gear assembly of the drive from any significant compressive or tensile stresses. The thrust bearing 138 consists of two separate races with ball bearings between the two races. When there is a compressive force on the device, for example, when distracting a bone 100, and thus resisting the tensile strength of the soft tissues, the thrust bearing 138 abuts against a magnet housing abutment or lip 150 located in the magnet housing 128. Additionally, though the device is not typically intended for pulling bones together, there may be some applications where this is desired. For example, in certain compressive nail applications it is the goal to hold two fractured sections of a bone together. Because the bone 100 may have fractured in a non-uniform or shattered pattern, it may be difficult to determine the desired length of the nail until after it is implanted and fully attached. In these situations, it can be easy to misjudge the length, and so a gap may exist between the separate sections or fragments of bone 100. By placing a slightly extended intramedullary device 110 and securing it, the device 110 may be retracted magnetically, after it has been secured within the bone fragments, so that it applies the desired compression between the two fragments. In these compressive nail applications, there would be tensile force on the device 110 and the thrust bearing 138 would abut against a splined housing abutment or lip 152. In both situations, the thrust bearing 138 and a rigid portion of one of the housing sections (e.g., lips 150, 152) take the large stresses, not the magnet/gear assembly of the drive system. In particular, the thrust bearing 138 is sandwiched between the abutment or lip 150 and the abutment or lip 152.
Turning specifically to
Preferably, such instructions or limits may be pre-programmed by the physician or even the manufacturer in a secure fashion such that user cannot alter the pre-programmed setting(s). For example, a security code may be used to pre-program and change the daily distraction limit (or other parameters). In this example, the person operating the external adjustment device 180 will not be able to distract more than one (1) mm in a day (or more than two mm in a day), and will not have the security code to be able to change this function of the external adjustment device 180. This serves as a useful lockout feature to prevent accidental over-extension of the intramedullary lengthening device 110. The safety feature may monitor, for example, rotational movement of magnets 186 (
The components of the magnetic handpiece 178 are held together between a magnet plate 190 and a front plate 192. Most of the components are protected by a cover 216. The magnets 186 rotate within a static magnet cover 188, so that the magnetic handpiece 178 may be rested directly on the patient, while not imparting any motion to the external surfaces of the patient. Prior to distracting the intramedullary lengthening device 110, the operator places the magnetic handpiece 178 over the patient near the location of the cylindrical magnet 134 as seen in
While the external adjustment device 180 is illustrated herein as including a motor 202 that is used to rotate or drive the magnets 186 in an alternative embodiment, the magnets 186 may be rotated manually. For example, the external adjustment device 180 may include a hand crank or the like that can be manipulated to rotate the magnets 186. In still another embodiment, the external adjustment device 180 may include a single magnet (e.g., permanent magnet) that is manually rotated about an axis by hand. For example, the single magnet may include a hand-held cylindrical magnet that is manually rotated by the user.
A cross section of a patient's lower thigh 218 with the intramedullary lengthening device 110 implanted within the femur 220 is shown in
The configuration of the magnetic handpiece 178 of the external adjustment device 180 as shown in
Turning to
Proximal locking screws 418 insert through locking screw apertures 430 in the extension rod 406. The extension rod 406 may be straight, or may have a specific curve 432, for example, for matching the proximal end of the femur or tibia. It can be appreciated that the modular arrangement allows the actuator 412 to be attached to one of numerous different models of extension rods 406, having different lengths, curves (including straight), diameters, hole diameters, and angulations. The first sterilization tray 402 may include many of these different extension rods 406, which may be selected as appropriate, and attached to the actuator 412. Because the actuator 412 is supplied sterile, this arrangement is also desirable, as only a single model need be supplied. However, if desired, several models of actuator may exist, for example, different diameters (10.5 mm, 12.0 mm, 9 mm, 7.5 mm) or with different distal screw aperture diameters, configurations or angulations. The preferred configuration for a multitude of patients and different bone types and sizes can be available, with a minimum number of sterile actuator models.
Turning to
Turning to
The torque limiting driver 488 of
It should be noted that although the embodiments of the intramedullary lengthening devices presented are shown to be used in a preferred orientation (distal vs. proximal), any of these embodiments may be used with the distraction shaft pointing distally or proximally. In addition, the invention may also be applied to distractable bone plates that are not located within the intramedullary canal, but are external to the bone.
An alternative lengthening scheme than those presented above may be also used. For example, one alternative includes the purposeful over-lengthening (to further stimulate growth) followed by some retraction (to minimize pain). For instance, each of four daily 0.25 mm lengthening periods may consist of 0.35 mm of lengthening, followed by 0.10 mm of retraction.
The materials of the accessories 408 are medical grade stainless steel, though other materials of varying densities may be used depending on the desired weight and the required size. The majority of the components of the intramedullary lengthening devices are preferably Titanium or Titanium alloys although some of the internal components may be made from stainless steel.
Intramedullary placed nails are commonly used in trauma of the long bones. Most nails are secured in place with transverse locking screws, much in a similar way to that described in the intramedullary lengthening device described here. In simple fractures it is relatively easy for the orthopedic trauma surgeon to place standard trauma nails correctly, so that the resulting fixture bone is close to the same length and configuration of the bone prior to fracture. However, in complex fractures, it is much more difficult to visually and physically “put the puzzle pieces back together” due to the nature of the fracture and the surrounding soft tissue trauma. Complex fractures many identified using a commonly used classification system such as the Muller AO Classification of Fractures. In addition, to promote healing, it is often desired to place compression between the separate segments of bone initially, for callus formation prior to callus ossification. Also, because it may be difficult to judge the ideal fixture length of the bone during the initial operation, it often would be desirable to adjust the length of the nail, and thus the bone during recovery from the operation, when a true comparison x-ray may be taken (length of bone on treated side vs. length of bone on contralateral side). It may be desired to take this x-ray with patient standing for an idealized comparison. The effect of the complex fracture may be such that a certain amount of distraction osteogenesis will be desired, to bring the fractured leg to a length that matches the other. During a lengthening period, it may be identified that the quality of the fracture callus is inadequate, and that a compression should be applied for a period of time. After this period of time, the lengthening process may be restarted, until the limb length is judged satisfactory. At this point, the nail length would be held constant until ossification is completed.
It should be appreciated that the variable length nail 616 is supplied to the user neither in its most retracted (shortest) configuration nor in its most distracted (longest) configuration. For example, in
The variable length nail 616 is inserted by making a first hole or incision in the skin of the patient in proximity to the fractured long bone and a canal is at least partially cleared through the center of the long bone. The variable length nail 616 is inserted into the canal and the first and second ends 618, 620 thereof are secured to the different portions of the fractured long bone. The different portions of the fractured long bone may be physically separate from one another prior to insertion. Alternatively, the variable length nail 616 may be inserted into the bone while the different portions are connected to one another. The bone may be subsequent cut using, for instance, a Gigli type wire saw. For insertion of the variable length nail 616, the proximal drill guide 434 may be used. The locking tab 454 of the proximal drill guide 434 is inserted into a locking groove 656 of the variable length nail 616. Additionally, the male thread 452 of the locking rod 448 is tightened into the female thread 658 of the variable length nail 616. The variable length nail 616 can be removed as described in other embodiments using the removal tool 468.
In a complex fracture patient, the surgeon may be unsure whether a standard trauma nail will be successful at fixing the fractured bone without complications and will thus choose to implant the variable length nail 616.
An alternative method for using the variable length nail 616 and external adjustment device 180 is depicted in
Alternatively, the femur depicted in
In cases of complex trauma, it often occurs that the bone may heal the correct length, or at least close to the desired length, but that one main bone portion may be misaligned angularly (in relation to the longitudinal axis) in relation to another bone portion. It may be desirable to correct this rotation of the bone using an alternative embodiment, as depicted in
The mechanism is similar in some ways to the axial distraction mechanisms of other embodiments disclosed herein, but additional features allow the rotation of a lead screw 746 to create controlled angular displacement of the second section 708 (and shaft 718) instead of axial displacement. As seen in
Depicted in
As the rotary nut 744 axially extends and rotates, the axial sliding hex portion 768 slides inside a female hex receptacle 770 of the shaft 718. The axial sliding hex portion 768 and the female hex receptacle 770 are rotationally keyed, each having a hexagonal shape, so that when the axial sliding hex portion 768 turns, the female hex receptacle 770 is turned with it thus turning the shaft 718. This construction allows relative axial sliding, namely, the shaft 718 rotates without any axial extension. The cross sectional shape may be any non-circular shape that is conducive to keying. For example, alternatives include a square shape or an elliptical shape. The shaft 718 is held axially on one end by a retaining collar 754 and on the other end by a lip 780, which in this embodiment is shown integral to the shaft 718, though alternatively, it can be made from a separate piece. An o-ring flange cap 756 is secured to the housing 728 (for example by welding or other direct boding technique) and contains one or more o-ring seals 758 within one or more o-ring flanges 760, thus sealing the internal contents of the housing 728.
The intramedullary rotational correction device 700 is preferably supplied to the customer in a sterile condition (for example by Gamma irradiation), and it may be supplied to the customer in numerous configurations. Three specific configurations will now be described. The supplier may supply the device in each of these configurations, or the supplier may supply the device in a single configuration, and the user may adjust the device into their desired configuration. The intramedullary rotational correction device 700 may be supplied with the internal thread 772 positioned towards a first end 782 of the lead screw 746 (near the pin 764). In this condition, the maximum amount of clockwise rotation may be applied to the second section 708 and shaft 718. Alternatively, the intramedullary rotational correction device 700 may be supplied with the internal thread 772 positioned towards a second end 784 of the lead screw 746. In this condition, the maximum amount of counter-clockwise rotation may be applied to the second section 708 and shaft 718. If it is not known at time of implantation, which direction a rotational discrepancy is possible (or probable), it may be desired to supply (or adjust) the intramedullary rotational correction device 700 so that the internal thread 772 is positioned at an intermediate section 786 of the lead screw 746. In this configuration, either clockwise rotation or counter-clockwise rotation will be available to the user.
In use, a patient is implanted with the intramedullary rotational correction device 700 and locking screws are used to secure the first section 702 and second section 708 to the bone to be treated. If a pre-existing rotational deformity is to be corrected, the implant is chosen with the correct amount of either clockwise or counter-clockwise rotation available, for example, as in the first two conditions described. If instead, the intramedullary rotational correction device 700 is being used as a trauma nail, knowing that the specific type of trauma may cause imprecise fixation, and thus a rotational discrepancy, it may be desired to have both clockwise and counter-clockwise rotation available. In this case, the third condition (allowing both clockwise and counter-clockwise rotation) would be the one desired. In this third condition, after the device is implanted, if the rotational discrepancy is discovered early, before consolidation of the bone fragments, the device may be operated as described to change the rotational orientation of the fragments gradually. If, however, the rotational discrepancy is discovered after the bone fragments have consolidated, an osteotomy may be made to allow the rotation between the fragments to be imparted.
While embodiments of the present invention have been shown and described, various modifications may be made without departing from the scope of the present invention. As one example, the devices described herein may be used to lengthen or reform a number of other bones such as the mandible or the cranium. Thus, while several embodiments have been described herein it should be appreciated that various aspects or elements are interchangeable with other separate embodiments. The invention, therefore, should not be limited, except to the following claims, and their equivalents.
Number | Name | Date | Kind |
---|---|---|---|
3810259 | Summers | May 1974 | A |
3976060 | Hildebrandt et al. | Aug 1976 | A |
4522501 | Shannon | Jun 1985 | A |
4940467 | Tronzo | Jul 1990 | A |
5074882 | Grammont et al. | Dec 1991 | A |
5263955 | Baumgart et al. | Nov 1993 | A |
5364396 | Robinson et al. | Nov 1994 | A |
5403322 | Herzenberg et al. | Apr 1995 | A |
5429638 | Muschler et al. | Jul 1995 | A |
5466261 | Richelsoph | Nov 1995 | A |
5516335 | Kummer et al. | May 1996 | A |
5527309 | Shelton | Jun 1996 | A |
5536269 | Spievack | Jul 1996 | A |
5549610 | Russell et al. | Aug 1996 | A |
5575790 | Chen et al. | Nov 1996 | A |
5620445 | Brosnahan et al. | Apr 1997 | A |
5620449 | Faccioli et al. | Apr 1997 | A |
5626579 | Muschler et al. | May 1997 | A |
5672177 | Seldin | Sep 1997 | A |
5704938 | Staehlin et al. | Jan 1998 | A |
5704939 | Justin | Jan 1998 | A |
5720746 | Soubeiran | Feb 1998 | A |
5762599 | Sohn | Jun 1998 | A |
5827286 | Incavo et al. | Oct 1998 | A |
5935127 | Border | Aug 1999 | A |
5961553 | Coty et al. | Oct 1999 | A |
5976138 | Baumgart et al. | Nov 1999 | A |
6022349 | McLeod et al. | Feb 2000 | A |
6033412 | Losken et al. | Mar 2000 | A |
6106525 | Sachse | Aug 2000 | A |
6126661 | Faccioli et al. | Oct 2000 | A |
6200317 | Aalsma et al. | Mar 2001 | B1 |
6234956 | He et al. | May 2001 | B1 |
6245075 | Betz et al. | Jun 2001 | B1 |
6336929 | Justin | Jan 2002 | B1 |
6358283 | Hogfors et al. | Mar 2002 | B1 |
6375682 | Fleischmann et al. | Apr 2002 | B1 |
6402753 | Cole et al. | Jun 2002 | B1 |
6416516 | Stauch et al. | Jul 2002 | B1 |
6417750 | Sohn | Jul 2002 | B1 |
6510345 | Van Bentem | Jan 2003 | B1 |
6565573 | Ferrante et al. | May 2003 | B1 |
6565576 | Stauch et al. | May 2003 | B1 |
6706042 | Taylor | Mar 2004 | B2 |
6796984 | Soubeiran | Sep 2004 | B2 |
6835207 | Zacouto et al. | Dec 2004 | B2 |
6918910 | Smith et al. | Jul 2005 | B2 |
7063706 | Wittenstein | Jun 2006 | B2 |
7357635 | Belfor et al. | Apr 2008 | B2 |
7458981 | Fielding | Dec 2008 | B2 |
7531002 | Sutton et al. | May 2009 | B2 |
7601156 | Robinson | Oct 2009 | B2 |
7611526 | Carl et al. | Nov 2009 | B2 |
7666184 | Stauch | Feb 2010 | B2 |
7753915 | Eksler et al. | Jul 2010 | B1 |
7776091 | Mastrorio et al. | Aug 2010 | B2 |
7794476 | Wisnewski | Sep 2010 | B2 |
7811328 | Molz, IV et al. | Oct 2010 | B2 |
7887566 | Hynes | Feb 2011 | B2 |
8043299 | Conway | Oct 2011 | B2 |
8105363 | Fielding et al. | Jan 2012 | B2 |
8147517 | Trieu et al. | Apr 2012 | B2 |
8147549 | Metcalf et al. | Apr 2012 | B2 |
8177789 | Magill et al. | May 2012 | B2 |
8211179 | Molz, IV et al. | Jul 2012 | B2 |
8216275 | Fielding et al. | Jul 2012 | B2 |
8221420 | Keller | Jul 2012 | B2 |
8241331 | Arnin | Aug 2012 | B2 |
8252063 | Stauch | Aug 2012 | B2 |
8282671 | Connor | Oct 2012 | B2 |
8298240 | Giger et al. | Oct 2012 | B2 |
8419801 | Disilvestro et al. | Apr 2013 | B2 |
8439915 | Harrison et al. | May 2013 | B2 |
8469908 | Asfora | Jun 2013 | B2 |
8486110 | Fielding et al. | Jul 2013 | B2 |
8529606 | Alamin et al. | Sep 2013 | B2 |
8562653 | Alamin et al. | Oct 2013 | B2 |
8568457 | Hunziker | Oct 2013 | B2 |
8632544 | Haaja et al. | Jan 2014 | B2 |
8641723 | Connor | Feb 2014 | B2 |
8663285 | Dall et al. | Mar 2014 | B2 |
8715282 | Pool | May 2014 | B2 |
8777947 | Zahrly et al. | Jul 2014 | B2 |
8852187 | Pool et al. | Oct 2014 | B2 |
8870959 | Arnin | Oct 2014 | B2 |
8894663 | Giger et al. | Nov 2014 | B2 |
8961567 | Hunziker | Feb 2015 | B2 |
8968406 | Arnin | Mar 2015 | B2 |
8992527 | Guichet | Mar 2015 | B2 |
20010034524 | Bales | Oct 2001 | A1 |
20020050112 | Koch et al. | May 2002 | A1 |
20020111629 | Phillips | Aug 2002 | A1 |
20020143344 | Taylor | Oct 2002 | A1 |
20020151898 | Sohngen et al. | Oct 2002 | A1 |
20020151978 | Zacouto et al. | Oct 2002 | A1 |
20020183750 | Buhler | Dec 2002 | A1 |
20030053855 | Baur | Mar 2003 | A1 |
20030144669 | Robinson | Jul 2003 | A1 |
20030195515 | Sohngen | Oct 2003 | A1 |
20040023623 | Stauch et al. | Feb 2004 | A1 |
20040030395 | Blunn et al. | Feb 2004 | A1 |
20040138663 | Kosashvili | Jul 2004 | A1 |
20040193266 | Meyer | Sep 2004 | A1 |
20050012617 | DiSilvestro et al. | Jan 2005 | A1 |
20050055025 | Zacouto et al. | Mar 2005 | A1 |
20050065529 | Liu et al. | Mar 2005 | A1 |
20050090823 | Bartimus | Apr 2005 | A1 |
20050107787 | Kutsenko | May 2005 | A1 |
20050159754 | Odrich | Jul 2005 | A1 |
20050234448 | McCarthy | Oct 2005 | A1 |
20050246034 | Soubeiran | Nov 2005 | A1 |
20050251109 | Soubeiran | Nov 2005 | A1 |
20050261779 | Meyer | Nov 2005 | A1 |
20060004459 | Hazebrouck et al. | Jan 2006 | A1 |
20060009767 | Kiester | Jan 2006 | A1 |
20060036259 | Carl et al. | Feb 2006 | A1 |
20060036323 | Carl et al. | Feb 2006 | A1 |
20060036324 | Sachs et al. | Feb 2006 | A1 |
20060047282 | Gordon | Mar 2006 | A1 |
20060052782 | Morgan et al. | Mar 2006 | A1 |
20060058792 | Hynes | Mar 2006 | A1 |
20060069447 | DiSilvestro et al. | Mar 2006 | A1 |
20060074448 | Harrison et al. | Apr 2006 | A1 |
20060079897 | Harrison et al. | Apr 2006 | A1 |
20060085043 | Stevenson | Apr 2006 | A1 |
20060235424 | Vitale et al. | Oct 2006 | A1 |
20060271107 | Harrison et al. | Nov 2006 | A1 |
20060293683 | Stauch | Dec 2006 | A1 |
20070010814 | Stauch | Jan 2007 | A1 |
20070015622 | Stauch | Jan 2007 | A1 |
20070016202 | Kraft et al. | Jan 2007 | A1 |
20070043376 | Leatherbury et al. | Feb 2007 | A1 |
20070173837 | Chan et al. | Jul 2007 | A1 |
20070233098 | Mastrorio et al. | Oct 2007 | A1 |
20070239159 | Altarac et al. | Oct 2007 | A1 |
20070239161 | Giger et al. | Oct 2007 | A1 |
20070244488 | Metzger et al. | Oct 2007 | A1 |
20070264605 | Belfor et al. | Nov 2007 | A1 |
20070270803 | Giger et al. | Nov 2007 | A1 |
20070276378 | Harrison et al. | Nov 2007 | A1 |
20080048855 | Berger | Feb 2008 | A1 |
20080065181 | Stevenson | Mar 2008 | A1 |
20080108995 | Conway et al. | May 2008 | A1 |
20080161933 | Grotz et al. | Jul 2008 | A1 |
20080167685 | Allard et al. | Jul 2008 | A1 |
20080228186 | Gall et al. | Sep 2008 | A1 |
20080255615 | Vittur et al. | Oct 2008 | A1 |
20090030462 | Buttermann | Jan 2009 | A1 |
20090062798 | Conway | Mar 2009 | A1 |
20090076597 | Dahlgren et al. | Mar 2009 | A1 |
20090093890 | Gelbart | Apr 2009 | A1 |
20090112262 | Pool et al. | Apr 2009 | A1 |
20090112263 | Pool et al. | Apr 2009 | A1 |
20090171356 | Klett | Jul 2009 | A1 |
20090192514 | Feinberg et al. | Jul 2009 | A1 |
20090254088 | Soubeiran | Oct 2009 | A1 |
20090275984 | Kim et al. | Nov 2009 | A1 |
20100049204 | Soubeiran | Feb 2010 | A1 |
20100100185 | Trieu et al. | Apr 2010 | A1 |
20100121323 | Pool et al. | May 2010 | A1 |
20100228167 | Ilovich et al. | Sep 2010 | A1 |
20100228357 | Stauch | Sep 2010 | A1 |
20100249847 | Jung et al. | Sep 2010 | A1 |
20110060336 | Pool et al. | Mar 2011 | A1 |
20110137347 | Hunziker | Jun 2011 | A1 |
20110196371 | Forsell | Aug 2011 | A1 |
20110196435 | Forsell | Aug 2011 | A1 |
20110230883 | Zahrly et al. | Sep 2011 | A1 |
20110238126 | Soubeiran | Sep 2011 | A1 |
20110257655 | Copf, Jr. | Oct 2011 | A1 |
20120035661 | Pool et al. | Feb 2012 | A1 |
20120053633 | Stauch | Mar 2012 | A1 |
20120088953 | King | Apr 2012 | A1 |
20120109207 | Trieu | May 2012 | A1 |
20120136356 | Doherty et al. | May 2012 | A1 |
20120203282 | Sachs et al. | Aug 2012 | A1 |
20120283781 | Arnin | Nov 2012 | A1 |
20130072932 | Stauch | Mar 2013 | A1 |
20130138017 | Jundt et al. | May 2013 | A1 |
20140005788 | Haaja et al. | Jan 2014 | A1 |
20140142631 | Hunziker | May 2014 | A1 |
20140195003 | Pool | Jul 2014 | A1 |
20140324047 | Zahrly et al. | Oct 2014 | A1 |
20150105824 | Moskowitz et al. | Apr 2015 | A1 |
Number | Date | Country |
---|---|---|
2655093 | Dec 2007 | CA |
68515687.6 | Dec 1985 | DE |
10 2005045070 | Apr 2007 | DE |
1905388 | Apr 2008 | EP |
2901991 | Dec 2007 | FR |
WO 9951160 | Oct 1999 | WO |
WO 2006090380 | Aug 2006 | WO |
WO 2007025191 | Mar 2007 | WO |
WO 2007015239 | Oct 2007 | WO |
WO 2007118179 | Oct 2007 | WO |
WO 2007144489 | Dec 2007 | WO |
WO 2008003952 | Jan 2008 | WO |
WO 2008040880 | Apr 2008 | WO |
WO 2011018778 | Feb 2011 | WO |
Entry |
---|
Cole, J., Paley, D., Dahl, M., “Operative Technique, ISKD. Intramedullary Skeletal Kinetic Distractor Tibial Surgical Technique” IS-0508(A)-OPT-US © Orthofix Inc. Nov. 2005 (28 pages). |
Dailey H., Daly Co., Galbraith J., Cronin M., Harty J., “A Novel Intramedullary Nail for Micromotion Stiumlation of Tibial Fractures”, Clinical Biomechanics, 2012. vol. 27, pp. 182-188. |
Gebhardt, M., Neel, M., Soubeiran, A., Dubousset, J., “Early clinical experience with a custom made growing endoprosthesis in children with malignant bone tumors of the lower extremity actioned by an external permanent magnet; The Phenix M. system”, International Society of Limb Salvage 14th International Symposium on Limb Salvage, Sep. 3, 2007, Hamburg, Germany, (2 pages). |
Goodship A., Cunningham J., Kentwright J., Strain Rate and Timing of Stimulation in Mechanical Modulation of Fracture Healing, Clinical Orthopaedics and Related Research, 1998. No. 355 Supplement, pp. S105-S115. |
Grimer, R., Chotel, F., Abudu, S., Tillman, R., Carter, S., “Non-invasive extendable endoprosthesis for children—expensive but worth it!”, International Society of Limb Salvage 14th International Symposium on Limb Salvage, Sep. 13, 2007, Hamburg, Germany (1 page). |
Guichet, J., Deromedis, B., Donnan, L., Peretti, G., Lascombes, P., Bado, F., “Gradual Femoral Lengthening with the Albizzia Intramedullary Nail”, Journal of Bone and Joint Surgery American Edition 2003, vol. 85, pp. 838-848 (12 pages). |
Gupta, A., Meswania, J., Pollock, R., Cannon, S., Briggs, T., Taylor, S. Blunn, G., “Non-Invasive distal Femoral Expanable Endoprosthesis for Limb-Salvage Surgery in Paediatric Tumours”, The Journal of Bone and Joint Surgery British Edition, 2006, vol. 88-B, No. 5, pp. 649-654, Churchill Livingstone London, England (6 pages). |
Hankemeier, S., Gosling, T., Pape, H., Wiebking, U., Krettek, C., “Limb Lengthening with the Intramedullary Skeletal Kinetic Distractor (ISKD)”, Operative Orthopädie und Tramatologie, 2005, vol. 17, No. 1, pp. 79-11, Urban & Vogel, Munich, Germany (23 pages). |
ISR of the International Search Authority for PCT/US2010/047842, dated Nov. 4, 2010 (4 pages). |
ISR of the International Search Authority for PCT/US2012/024691, dated Aug. 20, 2012 (6 pages). |
Kent, Matthew E. et al., Assessment and correction of femoral malrotation following intermedullay nailing of the femur, Acta Orthop. Belg., 2010, 76, 580-584. |
PCT Written Opinon of the International Searching Authority for PCT/US2012/024691, dated Aug. 30, 2012 (6 pages). |
Sharke, P., “The Machinery of Life”, Mechanical Engineering Magazine, Feb. 2004, Printed from Internet Site Oct. 24, 2007 http://www.memagazine.org/contents/current/features/moflife/moflife.html (10 pages). |
Souberiran, A., Gebhart, M. Miladi, L., Griffet, J., Neel, M., Dubousset, J., “The Phenix M System, a fully implanted non-invasive lengthening device externally controllable through the skin with the palm size permanent magnet. Applications in Limb salvage.” International Society of Limb Salvage 14th International Symposium on Limb Salvage. Sep. 13, 2007, Hamburg, Germany, (2 pages). |
Soubeiran, A., Gebhart, M., Miladi, L., Griffet, J., Neel, M., Dubousset, J., “The Phenix M System. A Fully Implanted Lengthening Device Externally Controllable Through the Skin with a Palm Size Permanent Magnet; Applications to Pediatric Orthopaedics”, 6th European Research Conference in Pediatric Orthopaedics, Oct. 6, 2006. Toulouse, France (7 pages). |
Verkerke, G., Koops, H., Veth, R., Grootenboer, H., De Boer, L., Oldhoff, J., Postma, A. “Development and Test of an Extendable Endoprothesis for Bone Reconstruction in the Leg”, The International Journal of Artificial Organs, 1994, vol. 17, No. 3, pp. 155-162. Wichtig Editore, Milan, Italy, (8 pages). |
Verkerke, G., Koops, H., Veth, R., Oldhoff, J., Nielsen, H., vanden Kroonenberg, H., Grootenboer, H., van Krieken, F., “Design of a Lengthening Element for a Modular Femur Endoprosthetic System”, Proceedings of the Institutuion of Mechancial Engineers Part H: Journal of Engineering in Medicine, 1989, vol. 203, No. 2, pp. 97-102, Mechanical Engineering Publications, London, England. (6 pages). |
Verkerke, G., Koops, H., Veth, R., van den Kroonenberg, H., Grootenboer, H., Nielsen, H., Oldhoff, J., Postma, A., “An Extendable Modular Endoprosthetic System for Bone Tumour Management in the Leg”, Journal of Biomedical Engineering, 1990, vol. 12, No. 2, pp. 91-96, Butterfield Scientific Limited, Guilford, England. (6 pages). |
Written Opinion of the International Search Authority for PCT/US2010/047842, dated Nov. 4, 2010 (6 pages). |
Number | Date | Country | |
---|---|---|---|
20150196332 A1 | Jul 2015 | US |
Number | Date | Country | |
---|---|---|---|
61442658 | Feb 2011 | US | |
61472055 | Apr 2011 | US |
Number | Date | Country | |
---|---|---|---|
Parent | 14146336 | Jan 2014 | US |
Child | 14667620 | US | |
Parent | 13370966 | Feb 2012 | US |
Child | 14146336 | US |