Expandable rod system to treat scoliosis and method of using the same

Information

  • Patent Grant
  • 9011499
  • Patent Number
    9,011,499
  • Date Filed
    Wednesday, January 21, 2015
    9 years ago
  • Date Issued
    Tuesday, April 21, 2015
    9 years ago
Abstract
Correction of a scoliotic curve in a spine comprises the steps of implanting an expanding rod isolated completely under the skin and attached to selected portions of the scoliotic curve of the spine at opposing ends of the rod; and producing a controlled force by means of expansion of the rod over at an extended time period under external control until a desire spinal curve is obtained. An incremental force is generated to stretch the scoliotic curve of the spine between the selected portions where attachment of the rod is defined. The controlled force is provided steadily for at least one month or alternatively 1-3 months. Multiple rods may be employed each associated with a different scoliotic curve of the spine or a different portion of the scoliotic curve.
Description
RELATED APPLICATIONS

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.


BACKGROUND OF THE INVENTION

1. Field of the Invention


The invention relates to the field of medical devices for treating scoliosis and methods of treatment using such medical devices, or methods of using such devices.


2. Description of the Prior Art


Adolescent (also called idiopathic) scoliosis is believed to be the direct result of a tight ligamentum flavum during rapid growth. The ligamentum flavum is a strong discontinuous (or segmental) ligament full of elastic fibers (which gives it its yellow color) that runs along the posterior aspect of the spinal canal. The posterior aspect of the dura, at any given spinal level, touches lamina for one third of its length, and ligamentum for the other two thirds. In the lumbar spine it acts as the center of rotation (and maybe the center of rotation for the thoracic as ell, which would help explain the limited rotation available in the thoracic spine).


If indeed scoliosis is the result of a tight ligamentum flavum, then correction of scoliosis should be achievable by mechanical stretching. Rapid correction of a scoliotic curve is now possible because great force through multiple points of solid fixation are now available. These methods still, however, are described as steps toward inserting instrumentation for a fusion of vertebrae. A slower and steady stretch over time, would be much less violent, and would allow the use of much less force and fewer points of fixation.


What is needed is some kind of device and mechanics to perform the needed mechanical stretching.


BRIEF SUMMARY OF THE INVENTION

The illustrated embodiment of the invention includes a method for correction of a scoliotic curve in a spine comprising the steps of implanting an expanding rod isolated completely under the skin and attached to selected portions of the scoliotic curve of the spine at opposing ends of the rod; and producing a controlled force by means of expansion of the rod over at an extended time period under external control until a desire spinal curve is obtained.


The step of producing a controlled force comprises the step of generating an incremental force to stretch the scoliotic curve of the spine between the selected portions where attachment of the rod is defined. The step of generating an incremental force to stretch the scoliotic curve of the spine comprises the step of generating a force using a curved rod in a direction tending to align with the spine at the selected portions where attachment of the rod is defined.


The step of implanting the expanding rod comprises implanting the expanding rod posteriorly to the spine.


The step of producing a controlled force by means of expansion of the rod over at an extended time period comprises the step of producing the controlled force at a predetermined level over time without any combination with fusion of vertebrae.


The step of producing the controlled force by means of expansion of the rod over at an extended time period comprises producing the controlled force steadily for at least one month or alternatively 1-3 months.


The step of producing the controlled force by means of expansion of the rod over at an extended time period comprises the step of producing the controlled force steadily for such period of time as is sufficient to stretch the ligamentum flavum of the spine enough to allow the spine to straighten.


The invention further contemplates repeating the steps of implanting an expanding rod with multiple rods, where each rod is associated with a different scoliotic curve of the spine or a different portion of the scoliotic curve of the spine and separately producing a controlled force by means of expansion of each corresponding rod over at a corresponding extended time period.


The step of producing the controlled force by means of expansion of the rod comprises the step of producing the controlled force by means of a ratcheted longitudinal extension of the rod powered by an energy sources biologically isolated from the rod by a skin barrier.


The invention also comprises an apparatus used for performing each of the above embodiments of the illustrated method. The invention thus includes among other embodiments a kit of a plurality of expanding rods with multiple rods, each rod being associated with a different scoliotic curve of the spine or a different portion of the scoliotic curve of the spine and separately producing a controlled force by means of expansion of each corresponding rod over at a corresponding extended time period.


The means for producing the controlled force by means of expansion of the rod comprises means for producing the controlled force by a ratcheted longitudinal extension of the rod powered by an energy sources biologically isolated from the rod by a skin barrier.


Stated in an alternative form, the invention includes embodiments where the invention is an apparatus for correction of a scoliotic curve in a spine comprising an expanding rod isolated completely under the skin; attachment screws to couple the rod to the spine at opposing ends of the rod; and a source of controlled force coupled to the rod to longitudinal extend the rod over an extended defined period of time under external control until a desire spinal curve is obtained.


The rod comprises a pair of telescopically coupled sleeves; and means to prevent relative rotation of the sleeves. The apparatus is combined with an external source of power, and in one embodiment the source of the controlled force comprises a torsion spring coupled to a second one of the pair of sleeves, a torsion motor coupled to the spring for torsioning the torsion spring, a power pick up electrically coupled to the torsion motor for powering the motor from the external source of power, a ratchet and a screw drive coupled to the ratchet at one end and to a first one of the pair of sleeves at an opposing end, so that a force applied to the screw drive from the torsion motor to the first one of the pair of sleeves over time longitudinally expands the collective length of the pair of sleeves. In the illustrated embodiment the torsion motor comprises a muscle wire.


More generally, where the invention is characterized as a combination of an expanding rod, attachment screws, a source of controlled force, and a ratchet, where the source of controlled force produces a force over a defined period of time, which force is continually maintained to some degree by the ratchet after initial generation by the source until the spine to which the force is steadily applied straightens at least to a partial degree.


While the apparatus and method has or will be described for the sake of grammatical fluidity with, functional explanations, it is to be expressly understood that the claims, unless expressly formulated under 35 USC 112, are not to be construed as necessarily limited in any way by the construction of “means” or “steps” limitations, but are to be accorded the full scope of the meaning and equivalents of the definition provided by the claims under the judicial doctrine of equivalents, and in the case where the claims are expressly formulated under 35 USC 112 are to be accorded full statutory equivalents under 35 USC 112. The invention can be better visualized by turning now to the following drawings wherein like elements are referenced by like numerals.





BRIEF DESCRIPTION OF THE DRAWINGS


FIG. 1 is a side perspective view of a telescoping rod of the invention showing the telescopic sleeves.



FIG. 2 is a side perspective view of a drive unit of the illustrated embodiment of the invention included in the rod of FIG. 1.



FIG. 2
a is a side perspective transparent view of the invention as depicted in FIGS. 1 and 2 shown in assembled form.



FIG. 2
b is a side perspective transparent view of an embodiment of a drive unit having a linear motor.



FIG. 3 is a posterior view, moving from the left to the right of the drawing, of a straight, lateral bending and scoliotic spine respectively.



FIG. 4 is a posterior view of the rod of the invention as implanted next to a bent scoliotic spine in the left most depiction and next to a straightened spine in the right most depiction of the drawing.



FIG. 5 is a side perspective view of a pair of pedicle screws showing a rotational coupling to the end of the rod of the invention.





The invention and its various embodiments can now be better understood by turning to the following detailed description of the preferred embodiments which are presented as illustrated examples of the invention defined in the claims. It is expressly understood that the invention as defined by the claims may be broader than the illustrated embodiments described below.


DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The invention comprises a rod, generally denoted by reference numeral 10, for the treatment of scoliosis by stow stretching of selected biological tissues, for example, a selected portion of the spine, which is implantable into the body and is under external control. The invention allows for surgical treatment of the spine without fusion of any of the vertebrae, and can be used not only for scoliosis, but also in pediatric orthopedics such as for leg or limb lengthening.


For the purposes of the illustrated disclosure, it is assumed that adolescent (also called idiopathic) scoliosis is the direct result of a tight ligamentum flavum during rapid growth. The evidence for this assumption is impressive and overwhelming. The second assumption made in the illustrated disclosure for the sake of simplicity is that we are treating a simple, single curve, although the indications and complexities of extending the use of the invention to more complex curves is explicitly within the scope of the invention. Where multiple rods 10 are implanted each rod 10 may be fixed across a different scoliotic curve where multiple scoliotic curves exist, or may be fixed across different portions of a single scoliotic curve. In such a case, each one of the multiple rods can be separately controlled to produce the needed straightening force or expansion.


The proposed device comprises an expanding or telescopic rod 10 as shown in side perspective view in FIG. 1. As described below, the opposing ends of rod 10 will be fixed to selected positions on the spine using conventional surgical screws. The rod 10 must produce a controlled force, slowly over time, under precise external control, and be isolated or implanted completely under the skin and protected by the natural barrier, which the skin provides. Rod 10 also needs to be small, powerful, simple enough to be readily manufactured, immune to accidental activation, and biologically inert. Rod 10 of the illustrated embodiment meets each and all of these criteria.


The rod 10 can be as small as ½″ (1.27 cm) in diameter and typically can be made much smaller, subject only to material limitations arising from the strength of the rod 10 itself. Rod 10 can be made from any bioengineered or biological inert material desired, and in the illustrated embodiment is fabricated from metal, such as surgical quality stainless steel. Rod 10 is comprised of an inner hollow cylindrical sleeve 14 telescopically disposed in outer, hollow cylindrical sleeve 16. The outer diameter of cylindrical sleeve 14 is chosen to telescopically slide without binding in the inner diameter of cylindrical sleeve 16 along their common longitudinal axes. A pin 12 is fixed to cylindrical sleeve 14 and extends radially therefrom through a longitudinal slot 18 defined through the wall of cylindrical sleeve 16 to stop rotation of cylindrical sleeve 14 relative to cylindrical sleeve 16 while allowing free relative longitudinal movement of cylindrical sleeve 14 relative to cylindrical sleeve 16 at least to the extent of the length of slot 18. Sleeves 14 and 16 are shown as circular cylinders in the illustrated embodiment, but pin 12 may be removed and elliptically or other prismatic shapes may be used in place of a cylindrical shape, which would equivalently stop or limit their relative rotation to each other. Therefore, when in the specification the term, “sleeve” is used without modification, it should be understood to have a general prismatic shape.


The larger cylindrical sleeve 16 is internally threaded. The small longitudinally extending post 20 on the right end 22 of the smaller cylindrical sleeve 14 as seen in FIG. 1 is where the drive unit, generally denoted by reference numeral 24, attaches as described below. Drive unit 24 as shown in the side perspective view of FIG. 2 is housed or disposed inside the cylindrical sleeve 16 with the left end 40 of a torsion spring 26 disposed within and affixed to sleeve 14 as shown in FIG. 2a. The opposing end 42 of torsion spring 26 is coupled to or bears against a segment end 44 of shell 36. Shell 36 is disposed in sleeve 16 as shown in FIG. 2a and rotates within the end of sleeve 14, but is held by a stop(s) 37 from telescopically sliding into sleeve 14. Shell 36 is thus longitudinally fixed relative to sleeve 14, but is free to rotate relative to sleeve 14 at least through a defined angular range. Thus, as shell 36 is rotated as described below, torsion spring 26 which has on end connected to sleeve 14 and the other end to shell 36 will wind up or down depending on the sense of rotation of shell 36.



FIG. 2 shows the drive unit in exploded view which is comprised of spring 26, motor 28, pickup coil 30, ratchet 32 and screw drive 34. These elements represent the simplest configuration for the drive unit 24, although it must be understood that any drive unit now known or later devised capable of providing the same or similar force as the illustrated drive unit 24 can be equivalently substituted without departing from the illustrated embodiment of the invention. Because of energy transfer considerations relating to coil 30 and wire 38, additional electronic or electrical components may be required as discussed below.


The motor 28 comprises a muscle wire 38 wound onto a cylindrical shell 36. Muscle wire 38 is well known to the art and is also called nitinol wire. When current is passed through the wire 38, it heats and contracts. Wire 38 is electrically connected to or in circuit with coil 30 in which a current is inductively generated. One end 48 of wire 38 is coupled or connected to shell 36. The opposing end 46 of wire 38 is coupled or connected to sleeve 14 at post 20 as shown in FIG. 2a. The contraction of wire 38 causes the entire remaining portion of drive unit 24 to rotate against the spring 26. In other words, as wire 38 ohmicly heats due to the current supplied to it from coil 30 and its length contracts, wire 38 will cause shell 36 to rotate. Shell 36 is rotationally coupled or connected to ratchet 32, which rotates with shell 36 in both senses of rotation. Ratchet 32 is coupled to screw drive 34 through a conventional ratcheting mechanism (not shown) thereby causing screw drive 34 to rotate in one sense of rotation, but slipping with respect to screw drive 34 in the opposite sense of direction. Thus, the screw drive 34 is rotated within sleeve 16 and driven forward or to the left in FIG. 1 causing sleeve 14 to telescope out of sleeve 16. The combined length of sleeves 14 and 16 thus increases. When the wire 38 cools there is no further torque applied to shell 36 by wire 38, and torsion spring 26 will rotate shell 36 back to its original angular position within drive unit 24. Grooves are cut into the screw threads to resist rotation of screw drive 34 in the opposite direction thereby insuring that ratchet 32 slips against the screw drive 34 when shell 3 is returned to its original angular orientation. Screw drive 34 remains in a new advanced longitudinal position within sleeve 16. In this manner rod 10 can be repeatedly incrementally lengthened by repeated heat cycling of motor 28. Rod 10 can only lengthen and the ratcheting action of ratchet 32 prevents it from shortening. The ratchet 32 is designed to release or disengage from screw drive 34 when a screw-driver or Allen wrench is placed into through-hex socket 50 of screw drive 34 during surgical placement and adjustment. Torsion spring 26 also provides some longitudinal compressive force which tends to urge ratchet 32 against screw drive 34, but placement of a tool through socket 50 allows ratchet 32 to be backed off and to disengage from screw 32. Withdrawal of the tool then allows spring 26 to urge ratchet 32 back into engagement with screw drive 34. The initial length of rod 10 can thus be manually adjusted up or down at the time of its initial surgical implantation.


The pick-up coil 30 receives energy from an external hand-held source of energy (not shown), such as a low frequency generator of electromagnetic radiation, which is brought into proximity with coil 30. Rod 10 is implanted beneath the skin barrier, while the source of energy is exterior to the body. The external inductive power source may be driven at conventional line frequency. In the event that the coil 30 is be able to efficiently drive the muscle wire 38, then either a storage capacitor with a control diode can be added in circuit with coil 30, or with more complexity, a battery with a diode voltage multiplier, and control diode could be used. Any means of impedance matching between coil 30 and wire 38 on one hand and between coil 30 and the inductive power source on the other may be employed. The use of external power sources and inductively powered implanted coils is well known to the art and are routinely used, for example, in charging implanted pacemaker devices.


For a first alternative, energy would be fed into the pick-up coil until enough was stored in the capacitor to drive the motor 28. Upon the firing of the motor 28 the hand-held device would sense the discharge, and shut-off for the prescribed lock-out period.


The second alternative is the same, except that an on-board battery assists in charging the capacitor, and thus requires significantly more control electronics.


Consider now the surgical implantation of rod 10 and its operation within the body. Two pedicle screws 52 as shown in FIG. 5 are placed at the top and two pedicle screws 52 at the bottom of the curve in a spine which being treated. Fixed head screws (not shown) are used. The expandable rod 10 is run above the fascia and beneath the skin between the two constructs. The rod 10 is then expanded daily typically for 2-3 months. The duration of treatment is variable and is determined according to medical considerations, which are not directly relevant here. After the desired curve in the spine is attained, the screws 52 and rod 10 are removed.



FIG. 3 shows moving from left to right in the drawing a posterior view of a normal straight, normal in lateral bending, and a scoliotic spine. Note that with normal lateral bending as shown in the center there is no significant rotation. Indeed, in scoliosis as shown in the right most depiction as in lateral bending there is no significant increase in rotation. This is because scoliosis is caused by a tight ligamentum flavum. Because of this scoliosis patients have loss of kyphosis or are even lordotic, even in the thoracic spine. These facts can make a slight curve in the expanding rod 10 very useful as shown in the left most depiction in FIG. 4. As the spine straightens, rod 10 is also flexible enough to slowly straighten with the spine as shown in the right most depiction in FIG. 4.



FIG. 4 shows the initial rod placement in the left most drawing. As the rod 10 expands, the spine has nowhere to go except to have the pedicle screws 52 cut out or for the spine to straighten. Because the expansion is slow, the pedicle screws 52 don't cut out. As the spine straightens, and also because the rod 10 is posterior to the ligamentum flavum and is in a poor position to stretch the anterior longitudinal ligament, the spine will be pushed from a horizontal into a vertical position, thus restoring normal kyphosis.


In order to allow both rotation, and some play for the re-establishment of kyphosis, the rod-to-pedicle screw articulation is provided as shown in FIG. 5. Rod 10 is coupled to pedicle screws 52 by means of a pin 54 fixed to screws 52. The extend end 58 of pin 54 is tapered and is disposed into a conical socket 56 defined into the adjacent end 60 of rod 10. This allows rod 10 to swivel around the pivot provided between the socket-to-pin connection to rod 10 by fixed pin 54 and pedicle screws 52.


Scoliosis can be treated without difficult, conspicuous, (and ineffective) bracing; and without fusion. The key is to stretch out the ligamentum flavum. The proposed device discussed should be effective in stretching the spine out of scoliosis. This device would also have several applications other than the spine.


Many alterations and modifications may be made by those having ordinary skill in the art without departing from the spirit and scope of the invention. Therefore, it must be understood that the illustrated embodiment has been set forth only for the purposes of example and that it should not be taken as limiting the invention as defined by the following invention and its various embodiments.


For example, while a cycling rotational motor 28 with a rotary ratchet has been described, it is entirely within the scope of the invention that a cycled linear motor 29 in combination with a linear ratcheting mechanism 31, both shown in FIG. 2b, could be substituted to replace the rotational motor embodiment illustrated in FIG. 2a.


Further, while an ohmicly heated motor is the preferred embodiment, it is also possible to conceive of use of a thermally or otherwise powered piston motor where the driving fluid may be heated by RF diathermy or ultrasound energy.


Still further the motor may be a rotary motor or linear motor with the propelling element of the motor is magnetically coupled to a moving magnetic field source and is combined through appropriate gearing to a ratcheting mechanism which telescopes rod 10.


Any means by which energy from an external source can be coupled into a motor which will mechanically telescope rod 10 is included within the spirit and scope of the invention.


Therefore, it must be understood that the illustrated embodiment has been set forth only for the purposes of example and that it should not be taken as limiting the invention as defined by the following claims. For example, notwithstanding the fact that the elements of a claim are set forth below in a certain combination, it must be expressly understood that the invention includes other combinations of fewer, more or different elements, which are disclosed in above even when not initially claimed in such combinations. A teaching that two elements are combined in a claimed combination is further to be understood as also allowing for a claimed combination in which the two elements are not combined with each other, but may be used alone or combined in other combinations. The excision of any disclosed element of the invention is explicitly contemplated as within the scope of the invention.


The words used in this specification to describe the invention and its various embodiments are to be understood not only in the sense of their commonly defined meanings, but to include by special definition in this specification structure, material or acts beyond the scope of the commonly defined meanings. Thus if an element can be understood in the context of this specification as including more than one meaning, then its use in a claim must be understood as being generic to all possible meanings supported by the specification and by the word itself.


The definitions of the words or elements of the following claims are, therefore, defined in this specification to include not only the combination of elements which are literally set forth, but all equivalent structure, material or acts for performing substantially the same function in substantially the same way to obtain substantially the same result. In this sense it is therefore contemplated that an equivalent substitution of two or more elements may be made for any one of the elements in the claims below or that a single element may be substituted for two or more elements in a claim. Although elements may be described above as acting in certain combinations and even initially claimed as such, it is to be expressly understood that one or more elements from a claimed combination can in some cases be excised from the combination and that the claimed combination may be directed to a subcombination or variation of a subcombination.


Insubstantial changes from the claimed subject matter as viewed by a person with ordinary skill in the art, now known or later devised, are expressly contemplated as being equivalently within the scope of the claims. Therefore, obvious substitutions now or later known to one with ordinary skill in the art are defined to be within the scope of the defined elements.


The claims are thus to be understood to include what is specifically illustrated and described above, what is conceptually equivalent, what can be obviously substituted and also what essentially incorporates the essential idea of the invention.

Claims
  • 1. A method for treating scoliosis comprising: implanting an expandable telescoping rod subcutaneously within a subject, the expandable telescoping rod disposed on a posterior of the spine of the subject, wherein the expandable telescoping rod is in a curved state when it is secured to the spine, and configured to be implanted by securing a first end of the expandable telescoping rod at a first location on the subject's spine and securing a second, opposing end of the expandable telescoping rod at a second location on the subject's spine, the expandable telescoping rod comprising a hollow outer sleeve and an inner sleeve coaxially disposed in the outer sleeve along a common longitudinal axis and wherein the hollow outer sleeve and inner sleeve are configured to limit rotational movement between the hollow outer sleeve and inner sleeve, the expandable telescoping rod further comprising an energy receiving element disposed on or in one of the hollow outer sleeve and inner sleeve, wherein the energy receiving element is configured to convert energy received by the energy receiving element from an external hand-held device located near the subject to telescopic movement of the expandable telescoping rod, and wherein the external hand-held device is configured to convey energy to the energy receiving element.
  • 2. The method of claim 1, wherein the hand-held device conveys energy to the energy receiving element using a periodic signal.
  • 3. The method of claim 1, wherein the expandable telescoping rod runs above the subject's fascia and beneath the subject's skin.
  • 4. The method of claim 1, wherein the energy receiving element is disposed in the hollow outer sleeve.
  • 5. The method of claim 1, wherein the expandable telescoping rod is implanted on a subject with adolescent scoliosis.
  • 6. The method of claim 1, wherein the energy receiving element comprises a rotatable propelling element.
  • 7. The method of claim 1, further comprising removing the expandable telescoping rod from the subject after the spinal condition is obtained.
  • 8. A method for treating scoliosis comprising: positioning an external hand-held device near a subject within which an expandable telescoping rod has been implanted subcutaneously, the expandable telescoping rod disposed on a posterior of the spine of the subject, wherein the expandable telescoping rod is in a curved state when it is secured to the spine, and configured to be implanted by securing a first end of the expandable telescoping rod at a first location on the subject's spine and securing a second, opposing end of the expandable telescoping rod at a second location on the subject's spine, the expandable telescoping rod comprising a hollow outer sleeve and an inner sleeve coaxially disposed in the outer sleeve along a common longitudinal axis and wherein the hollow outer sleeve and inner sleeve are configured to limit rotational movement between the hollow outer sleeve and inner sleeve; andconveying energy from the external hand-held device to an energy receiving element disposed on or in one of the hollow outer sleeve and inner sleeve such that the conveyed energy received by the energy receiving element causes telescopic movement of the expandable telescoping rod.
  • 9. The method of claim 8, wherein the hand-held device is locked out for a period of time after actuation.
  • 10. The method of claim 8, wherein the hand-held device conveys energy to the energy receiving element using a periodic signal.
  • 11. The method of claim 8, wherein the expandable telescoping rod is implanted on a subject with adolescent scoliosis.
  • 12. The method of claim 8, wherein at least a posterior portion of the spine is stretched.
  • 13. The method of claim 8, wherein the energy receiving element comprises a rotatable propelling element.
  • 14. The method of claim 8, wherein the telescoping rod is expanded over a period of less than 3 months.
  • 15. A method for treating scoliosis comprising: supplying an expandable telescoping rod configured to be implanted subcutaneously within a subject, the expandable telescoping rod disposed on a posterior of the spine of the subject, wherein the expandable telescoping rod is in a curved state when it is secured to the spine, and configured to be implanted by securing a first end of the expandable telescoping rod at a first location on the subject's spine and securing a second, opposing end of the expandable telescoping rod at a second location on the subject's spine, the expandable telescoping rod comprising a hollow outer sleeve and an inner sleeve coaxially disposed in the outer sleeve along a common longitudinal axis and wherein the hollow outer sleeve and inner sleeve are configured to limit rotational movement between the hollow outer sleeve and inner sleeve, the expandable telescoping rod further comprising an energy receiving element disposed on or in one of the hollow outer sleeve and inner sleeve, wherein the energy receiving element is configured to convert energy received by the energy receiving element from an external hand-held device located near the subject to telescopic movement of the expandable telescoping rod, and wherein the external hand-held device is configured to convey energy to the energy receiving element.
  • 16. The method of claim 15, wherein at least one of the first and second ends of the expandable telescoping rod is secured to the spine via a rotational coupling.
  • 17. The method of claim 16, wherein the rotational coupling comprises at least one pedicle screw.
  • 18. The method of claim 15, wherein telescopic movement of the expandable telescoping rod also results in rotation of the expandable telescoping rod about a pivot disposed at one or both of the first end and the second end.
  • 19. The method of claim 15, wherein the expandable telescoping rod has a diameter of ½ inch or less.
  • 20. The method of claim 15, wherein the energy receiving element is disposed in the hollow outer sleeve.
  • 21. The method of claim 15, wherein the expandable telescoping rod is implanted on a subject with adolescent scoliosis.
  • 22. The method of claim 15, wherein the expandable telescoping rod is expanded with a ratcheting movement.
  • 23. The method of claim 15, wherein the energy receiving element comprises a rotatable propelling element.
  • 24. A method for treating scoliosis comprising: supplying an expandable telescoping rod configured to be implanted subcutaneously within a subject, the expandable telescoping rod disposed on a posterior of the spine of the subject, wherein the expandable telescoping rod is in a curved state when it is secured to the spine, and configured to be implanted by securing a first end of the expandable telescoping rod at a first location on the subject's spine and securing a second, opposing end of the expandable telescoping rod at a second location on the subject's spine, the expandable telescoping rod comprising a hollow outer sleeve and an inner sleeve coaxially disposed in the outer sleeve along a common longitudinal axis and wherein the hollow outer sleeve and inner sleeve are configured to limit rotational movement between the hollow outer sleeve and inner sleeve, the expandable telescoping rod further comprising an energy receiving element disposed on or in one of the hollow outer sleeve and inner sleeve, wherein the energy receiving element is configured to convert energy received by the energy receiving element from an external hand-held device to telescopic movement of the expandable telescoping rod; andsupplying the external hand-held device configured to be located near the subject and convey energy from the external hand-held device to the energy receiving element.
  • 25. The method of claim 24, wherein the hand-held device is locked out for a period of time after actuation.
  • 26. The method of claim 24, wherein the hand-held device conveys energy to the energy receiving element using a periodic signal.
  • 27. The method of claim 24, wherein the expandable telescoping rod has a diameter of ½ inch or less.
  • 28. The method of claim 24, wherein the energy receiving element is disposed in the hollow outer sleeve.
  • 29. The method of claim 24, wherein the energy receiving element comprises a rotatable propelling element.
  • 30. The method of claim 24, wherein the expandable telescoping rod is expanded with a ratcheting movement.
US Referenced Citations (147)
Number Name Date Kind
2702031 Wenger Feb 1955 A
3810259 Summers May 1974 A
3976060 Hildebrandt et al. Aug 1976 A
4078559 Nissinen Mar 1978 A
4448191 Rodnyansky et al. May 1984 A
4522501 Shannon Jun 1985 A
4537520 Ochiai et al. Aug 1985 A
4573454 Hoffman Mar 1986 A
4658809 Ulrich Apr 1987 A
4854304 Zielke Aug 1989 A
4931055 Bumpus et al. Jun 1990 A
4957495 Kluger Sep 1990 A
4973331 Pursley et al. Nov 1990 A
5010879 Moriya et al. Apr 1991 A
5030235 Campbell, Jr. Jul 1991 A
5074882 Grammont et al. Dec 1991 A
5092889 Campbell, Jr. Mar 1992 A
5133716 Plaza Jul 1992 A
5261908 Campbell, Jr. Nov 1993 A
5263955 Baumgart et al. Nov 1993 A
5290289 Sanders et al. Mar 1994 A
5336223 Rogers Aug 1994 A
5466261 Richelsoph Nov 1995 A
5527309 Shelton Jun 1996 A
5575790 Chen et al. Nov 1996 A
5626579 Muschler et al. May 1997 A
5632744 Campbell, Jr. May 1997 A
5672175 Martin Sep 1997 A
5672177 Seldin Sep 1997 A
5704939 Justin Jan 1998 A
5720746 Soubeiran Feb 1998 A
5800434 Campbell, Jr. Sep 1998 A
5810815 Morales Sep 1998 A
5902304 Walker et al. May 1999 A
5961553 Coty et al. Oct 1999 A
6033412 Losken et al. Mar 2000 A
6074882 Eckardt Jun 2000 A
6106525 Sachse Aug 2000 A
6126660 Dietz Oct 2000 A
6200317 Aalsma et al. Mar 2001 B1
6241730 Alby Jun 2001 B1
6336929 Justin Jan 2002 B1
6343568 McClasky Feb 2002 B1
6358283 Hogfors et al. Mar 2002 B1
6417750 Sohn Jul 2002 B1
6510345 Van Bentem Jan 2003 B1
6537196 Creighton, IV et al. Mar 2003 B1
6554831 Rivard et al. Apr 2003 B1
6565576 Stauch et al. May 2003 B1
6616669 Ogilvie et al. Sep 2003 B2
6657351 Chen et al. Dec 2003 B2
6765330 Baur Jul 2004 B2
6796984 Soubeiran Sep 2004 B2
6835207 Zacouto et al. Dec 2004 B2
6849076 Blunn et al. Feb 2005 B2
6852113 Nathanson et al. Feb 2005 B2
6918910 Smith et al. Jul 2005 B2
6971143 Domroese Dec 2005 B2
7011658 Young Mar 2006 B2
7029472 Fortin Apr 2006 B1
7135022 Kosashvili et al. Nov 2006 B2
7481841 Hazebrouck et al. Jan 2009 B2
7942908 Sacher et al. May 2011 B2
8343192 Kiester Jan 2013 B2
8623036 Harrison et al. Jan 2014 B2
20020050112 Koch et al. May 2002 A1
20020138077 Ferree Sep 2002 A1
20030144669 Robinson Jul 2003 A1
20030220643 Ferree Nov 2003 A1
20040030395 Blunn et al. Feb 2004 A1
20040116945 Sharkawy et al. Jun 2004 A1
20040138663 Kosashvili et al. Jul 2004 A1
20040193266 Meyer Sep 2004 A1
20040236329 Panjabi Nov 2004 A1
20050055025 Zacouto et al. Mar 2005 A1
20050080427 Govari et al. Apr 2005 A1
20050107787 Kutsenko May 2005 A1
20050113831 Franck et al. May 2005 A1
20050113927 Malek May 2005 A1
20050159637 Nelson et al. Jul 2005 A9
20050234448 McCarthy Oct 2005 A1
20050246034 Soubeiran Nov 2005 A1
20050251109 Soubeiran Nov 2005 A1
20050261779 Meyer Nov 2005 A1
20060004447 Mastrorio et al. Jan 2006 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
20060136062 DiNello et al. Jun 2006 A1
20060155279 Ogilvie Jul 2006 A1
20060195087 Sacher et al. Aug 2006 A1
20060195088 Sacher et al. Aug 2006 A1
20060204156 Takehara et al. Sep 2006 A1
20060271107 Harrison et al. Nov 2006 A1
20060282106 Cole et al. Dec 2006 A1
20070010834 Sharkawy et al. Jan 2007 A1
20070010887 Williams et al. Jan 2007 A1
20070016202 Kraft et al. Jan 2007 A1
20070043376 Leatherbury et al. Feb 2007 A1
20070050030 Kim Mar 2007 A1
20070055125 Anderson et al. Mar 2007 A1
20070173837 Chan et al. Jul 2007 A1
20070179493 Kim Aug 2007 A1
20070191846 Bruneau et al. Aug 2007 A1
20070213751 Scirica et al. Sep 2007 A1
20070213812 Webler et al. Sep 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
20070255088 Jacobson et al. Nov 2007 A1
20070255273 Fernandez et al. Nov 2007 A1
20070270803 Giger et al. Nov 2007 A1
20070276368 Trieu et al. Nov 2007 A1
20070276369 Allard et al. Nov 2007 A1
20070276378 Harrison et al. Nov 2007 A1
20070288024 Gollogly Dec 2007 A1
20080027436 Cournoyer et al. Jan 2008 A1
20080033436 Song et al. Feb 2008 A1
20080048855 Berger Feb 2008 A1
20080065181 Stevenson Mar 2008 A1
20080177319 Schwab Jul 2008 A1
20080177326 Thompson Jul 2008 A1
20080272928 Shuster et al. Nov 2008 A1
20090030462 Butterman Jan 2009 A1
20090082690 Phillips et al. Mar 2009 A1
20090093820 Trieu et al. Apr 2009 A1
20090105766 Thompson et al. Apr 2009 A1
20090204156 McClintock et al. Aug 2009 A1
20100049204 Soubeiran Feb 2010 A1
20100106192 Barry Apr 2010 A1
20100217271 Pool et al. Aug 2010 A1
20100228167 Llovich et al. Sep 2010 A1
20110004076 Janna et al. Jan 2011 A1
20110137347 Hunziker Jun 2011 A1
20120022597 Gephart et al. Jan 2012 A1
20120089191 Altarac et al. Apr 2012 A1
20140128868 Harrison et al. May 2014 A1
Foreign Referenced Citations (13)
Number Date Country
8515687 Oct 1985 DE
102005045070 Apr 2007 DE
2900563 Nov 2007 FR
2901991 Dec 2007 FR
WO 9951160 Oct 1999 WO
WO 2004019796 Mar 2004 WO
WO 2006090380 Aug 2006 WO
WO 2007015239 Feb 2007 WO
WO 2007025191 Mar 2007 WO
WO 2007118179 Oct 2007 WO
WO 2007144489 Dec 2007 WO
WO 2008003952 Jan 2008 WO
WO 2008040880 Apr 2008 WO
Non-Patent Literature Citations (44)
Entry
Abe, J., Nagata, K., Ariyoshi, M., Inoue, A., “Experimental External Fixation Combined with Pecutaneous Discectomy in the Management of Scoliosis”, Spine, 1999, vol. 24, No. 7, pp. 646-653, Lippincott Co., Philadelphia, U.S.A.
Buchowski, J., Bhatnagar, R., Skaggs, D., Sponseller, P., “Temporary Internal Distraction as an Aid to Correction of Severe Scoliosis”, Journal of Bone and Joint Surgery American Edition, 2006, vol. 88A, No. 9, pp. 2035-2041, Journal of Bone and Joint Surgery, Boston, U.S.A.
Buchowski, J., Skaggs, D., Sponseller, P., “Temporary Internal Distraction as an Aid to Correction of Severe Scoliosis, Surgical Technique”, Journal of Bone and Joint Surgery American Edition, 2007, vol. 89A No. Supp 2 (Pt. 2), pp. 297-309, Journal of Bone and Joint Surgery, Boston, U.S.A.
Burke, J. “Design of a Minimally Invasive Non Fusion Device for the Surgical Management of Scoliosis in the Skeletally Immature”, Studies in Health Technology and Informatics, 2006, vol. 123, pp. 378-384, IOS Press, Amsterdam, The Netherlands.
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.
Daniels, A., Gemperline, P., Grahn, A., Dunn, H., “A New Method for Continuous Intraoperative Measurement of Harrington Rod Loading Patterns”, Annals of Biomedical Engineering, 1984, vol. 12, No. 3, pp. 233-246, Dordrecht Kluwer Academic/Plenum Publishers, New York, U.S.A.
Edelan, H., Eriksson, G., Dahlberg, E., “Instrument for distraction by limited surgery in scoliosis treatment”, Journal of Biomedical Engineering, 1981, vol. 3, No. 2, pp. 143-146, Butterfield Scientific Limited, Guilford, England.
Ember, T., Noordeen, H., “Distraction forces required during growth rod lengthening”, Journal of Bone and Joint Surgery British Edition, 2006, vol. 88B, No. Supp II, p. 229, Churchill Livingstone, London, England.
Gao et aI., CHD7 Gene Polymorphisms are Associated with Susceptibility to Idiopathic Scoliosis, American Journal of Human Genetics, vol. 80, pp. 957-965 (May 2007).
Gebhart, 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. 13, 2007, Hamburg, Germany.
Gillespie, R., O'Brien, J., “Harrington Instrumentation without Fusion”, The Journal of Bone and Joint Surgery British Edition, 1981, vol. 63B, No. 3, p. 461, Churchill Livingstone, London, England.
Grass, P., Soto, A., Araya, H., “Intermittent Distracting Rod for Correction for High Neurologic Risk Congenital Scoliosis”, Spine, 1997, vol. 22, No. 16, pp. 1922-1927, Lippincott Co., Philadelphia, U.S.A.
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.
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 Expandable 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.
Hankemeier, S., Gosling, T., Pape, H., Wiebking, U., Krettek, C., “Limb Lengthening with the Intramedullary Skeletal Kinetic Distractor (ISKD)”, Operative Orthopadie und Traumatologie, 2005, vol. 17, No. 1, pp. 79-101, Urban & Vogel, Munich, Germany.
Harrington, P., “Treatment of Scoliosis: Correction and Internal Fixation by Spine Instrumentation”, The Journal of Bone and Joint Surgery American Edition, 1962, vol. 44A, No. 4, pp. 591-610, Journal of Bone and Joint Surgery, Boston, U.S.A.
Hazem Elsebaie M.D., Single Growing Rods (Review of 12 cases). Changing the Foundations: Does it affect the Results?, J Child Orthop. (2007) 1:258.
Klemme, W., Denis, F., Winter, R., Lonstein, J., Koop, S., “Spinal Instrumentation without Fusion for Progressive Scoliosis in Young Children”, Journal of Pediatric Orthopedics. 1997, vol. 17, No. 6, pp. 734-742, Raven Press, New York, U.S.A.
Lonner, B., “Emerging minimally invasive technologies for the management of scoliosis”, Orthopedic Clinics of North America, 2007; vol. 38, No. 3, pp. 431-440, Saunders, Philadelphia, U.S.A.
Marco Teli, M.D. et al. Measurement of Forces Generaed During Distraction of Growing Rods. Marco Teli, J. Child Orthop (2007) 1:257-258.
Mineiro, J., Weinstein, S., “Subcutaneous Rodding for Progressive Spinal Curvatures: Early Results”, Journal of Pediatric Orthopedics, 2002, vol. 22, No. 3, pp. 290-295, Raven Press, New York, U.S.A.
Moe, J., Kharrat, K., Winter, R., Cummine, J., “Harrington Instrumentation without Fusion Plus External Orthotic Support for the Treatment of Difficult Curvature Problems in Young Children”, Clinical Orthopaedics and Related Research, 1984, No. 185, pp. 35-45, Lippincott Co., Philadelphia, U.S.A.
Nachemson, A., Elfstrom, G., “Intravital Wireless Telemetry of Axial Forces in Harrington Distraction Rods in Patients with Idiopathic Scoliosis”, The Journal of Bone and Joint Surgery American Edition, 1971, vol. 53A, No. 3, pp. 445-465, Journal of Bone and Joint Surgery, Boston, U.S.A.
Nachlas, I., Borden, J., “The cure of experimental scoliosis by directed growth control”. The Journal of Bone and Joint Surgery American Edition, 1951, vol. 33, No. A:1, pp. 24-34, Journal of Bone and Joint Surgery, Boston, U.S.A.
Newton, P., “Fusionless Scoliosis Correction by Anterolateral Tethering . . . Can it Work?”, 39th Annual Scoliosis Research Society Meeting, Sep. 6, 2004, Buenos Aires, Argentina (transcript and slides supplied).
Rathjen, K., Wood, M., McClung, A., Vest, Z., “Clinical and Radiographic Results after Implant Removal in Idiopathic Scoliosis”, Spine, 2007, vol. 32, No. 20, pp. 2184-2188, Lippincott Co., Philadelphia, U.S.A.
Reyes-Sanchez, A., Rosales, L., Miramontes, V., “External Fixation for Dynamic Correction of Severe Scoliosis”, The Spine Journal, 2005, vol. 5, No. 4, pp. 418-426, Elsevier Science Inc., New York, U.S.A.
Rinsky, L., Gamble, J., Bleck, E., “Segmental Instrumentation without fusion in Children with Progressive Scoliosis”, Journal of Pediatric Orthopedics, 1985, vol. 5, No. 6, pp. 687-690, Raven Press, New York, U.S.A.
Schmerling, M., Wilkov, M., Sanders, A., “Using the Shape Recovery of Nitinol in the Harrington Rod Treatment of Scoliosis”, Joumal of Biomedical Materials Research, 1976, vol. 10, No. 6, pp. 879-892, Wiley, Hoboken, U.S.A.
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.
Smith J., “The Use of Growth-Sparing Instrumentation in Pediatric Spinal Deformity”, Orthopedic Clinics of North America, 2007, vol. 38, No. 4, pp. 547-552, Saunders, Philadelphia, U.S.A.
Soubeiran, 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 a palm size permanent magnet. Applications in limb salvage” International Society of Limb Salvage 14th International Symposium on Limb Salvage, Sep. 13, 2007, Hamburg, Germany.
Soubeiran, A., Gebhart, M., Miladi, L., Griffet, J., Neel, M., Dubousset, J., The Phenix M System. A Mechanical 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.
Takaso, M., Moriya, H., Kitahara, H., Minami, S., Takahashi, K., Isobe, K., Yamagata, M., Otsuka, Y., Nakata, Y., Inoue, M., “New remote-controlled growing-rod spinal instrumentation possibly applicable for scoliosis in young children”, Journal of Orthopaedic Science, 1998, vol. 3, No. 6, pp. 336-340, Springer-Verlag, Tokyo, Japan.
Tello C., “Harrington Instrumentation without Arthrodesis and Consecutive Distraction Program for Young Children with Server Spinal Deformities: Experience and Technical Details”, Orthopedic Clinics of North America, vol. 25, No. 2 1994. pp. 333-351. (19 pages).
Thompson, G., Akbarnia, B., Campbell, R., “Growing Rod Techniques in Early-Onset Scoliosis”, Journal of Pediatric Orthopedics, 2007, vol. 27, No. 3, pp. 354-361, Raven Press, New York, U.S.A.
Thompson, G., Lenke, L., Akbarnia, B., McCarthy, R, Campbell, Jr., R, “Early Onset Scoliosis: Future Directions”, 2007, Journal of Bone and Joint Surgery American Edition, vol. 89A, No. Supp 1, pp. 163-166, Journal of Bone and Joint Surgery, Boston, U.S.A.
Trias, A., Bourassa, P., Massoud, M., “Dynamic Loads Experienced in Correction of Idiopathic Scoliosis Using Two Types of Harrington Rods”, Spine, 1979, vol. 4, No. 3, pp. 228-235, Lippincott Co., Philadelphia, U.S.A.
Verkerke, G., Koops, H., Veth, R, Grootenboer, H., De Boer, L., Oldhoff, J., Postma, A. “Development and Test of an Extendable Endoprosthesis for Bone Reconstruction in the Leg”, The International Journal of Artificial Organs, 1994, vol. 17, No. 3, pp. 155-162, Wichtig Editore, Milan, Italy.
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 Institution of Mechanical Engineers Part H: Journal of Engineering in Medicine, 1989, vol. 203, No. 2, pp. 97-102, Mechanical Engineering Publications, London, England.
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.
Wenger, H., “Spine Jack Operation in the Correction of Scoliotic Deformity”, Archives of Surgery, 1961, vol. 83, pp. 123-132 (901-910), American Medical Association, Chicago, U.S.A.
White, A., Panjabi, M., “The Clinical Biomechanics of Scoliosis”, Clinical Orthpaedics and Related Research, 1976, No. 118, pp. 100-112, Lippincott Co., Philadelphia, U.S.A.
Provisional Applications (1)
Number Date Country
60584961 Jul 2004 US
Divisions (1)
Number Date Country
Parent 11172678 Jun 2005 US
Child 12421569 US
Continuations (3)
Number Date Country
Parent 14321386 Jul 2014 US
Child 14601999 US
Parent 13691530 Nov 2012 US
Child 14321386 US
Parent 12421569 Apr 2009 US
Child 13691530 US