Distraction osteogenesis device and methods

Patent metadata

Field	Value
Publication number	US-12048459-B2
Application number	US-202217735295-A
Country	US
Kind code	B2
Filing date	May 3, 2022
Priority date	May 3, 2021
Publication date	Jul 30, 2024
Grant date	Jul 30, 2024

Abstract

The present disclosure is directed to implantable distraction osteogenesis devices and methods of their use. In a non-limiting embodiment, the device has a guide, a first bone attachment device slidably engaged with the guide, a force delivery mechanism coupled to the first bone attachment device and operably engaged with the guide, a regulator operably engaged with the force delivery mechanism, and a second bone attachment device rigidly fixed to the guide, wherein the force delivery mechanism is configured to exert a force to move the first bone attachment device along the guide at a predetermined rate, and the regulator is configured to control the movement of the first bone attachment device along the guide without percutaneous intervention.

First claim

What is claimed:

1. An implantable distraction osteogenesis device comprising:
a guide;
a first bone attachment device slidably engaged with the guide;
a force delivery mechanism coupled to the first bone attachment device and operably engaged with the guide;
a regulator operably engaged with the force delivery mechanism, wherein the regulator comprises a centrifugal regulator; and
a second bone attachment device rigidly fixed to the guide, wherein:
the force delivery mechanism is configured to exert a force to move the first bone attachment device along the guide at a predetermined rate; and
the regulator is configured to control the force delivered to the first bone attachment device by the force delivery mechanism thereby controlling movement of the first bone attachment device along the guide without percutaneous intervention, and wherein the distraction osteogenesis device is totally subcutaneously implantable and is absent a percutaneous attachment for externally manipulating an internal portion of the device.

2. The implantable distraction osteogenesis device of claim 1 , wherein the predetermined rate is in a range of 0.1 millimeters (mm) to 2.0 mm per 24 hours.

3. The implantable distraction osteogenesis device of claim 1 , wherein the guide is configured to move the first bone attachment device in a linear path.

4. The implantable distraction osteogenesis device of claim 1 , wherein the guide is configured to move the first bone attachment device in a pre-defined three-dimensional path.

5. The implantable distraction osteogenesis device of claim 1 , wherein:
the guide has a maximum dimension in a range of about 1 to 5 centimeters (cm); and
the regulator has a maximum dimension in a range of about 1 to 4 cm.

6. The implantable distraction osteogenesis device of claim 1 , wherein the force delivery mechanism is configured to generate a force in a range of about 40 N to about 70 N.

7. The implantable distraction osteogenesis device of claim 1 , wherein the guide engages the regulator via at least one of a rack-and-pinion gear, an angled gear, an infinite screw, and a spool.

8. An implantable distraction osteogenesis device comprising:
a guide;
a first bone attachment device slidably engaged with the guide;
a force delivery mechanism coupled to the first bone attachment device and operably engaged with the guide;
a regulator operably engaged with the force delivery mechanism; and
a second bone attachment device rigidly fixed to the guide, wherein:
the force delivery mechanism is configured to exert a force to move the first bone attachment device along the guide at a predetermined rate;
the regulator is configured to control the force delivered to the first bone attachment device by the force delivery mechanism thereby controlling movement of the first bone attachment device along the guide without percutaneous intervention, and wherein the distraction osteogenesis device is totally subcutaneously implantable and is absent a percutaneous attachment for externally manipulating an internal portion of the device; and
the force delivery mechanism comprises a spring.

9. The implantable distraction osteogenesis device of claim 8 , wherein the spring is selected from the group consisting of a spiral spring, a leaf spring, a coiled spring, a clock spring, a mainspring, an Omega-shaped spring, a U-shaped spring, a torsion spring, and an extension spring.

10. An implantable distraction osteogenesis device comprising:
a guide;
a first bone attachment device slidably engaged with the guide;
a force delivery mechanism coupled to the first bone attachment device and operably engaged with the guide;
a regulator operably engaged with the force delivery mechanism; and
a second bone attachment device rigidly fixed to the guide, wherein:
the force delivery mechanism is configured to exert a force to move the first bone attachment device along the guide at a predetermined rate; and
the regulator is configured to control the force delivered to the first bone attachment device by the force delivery mechanism thereby controlling movement of the first bone attachment device along the guide without percutaneous intervention, and wherein the distraction osteogenesis device is totally subcutaneously implantable and is absent a percutaneous attachment for externally manipulating an internal portion of the device; and

wherein the regulator further comprises:
a balance wheel and balance spring;
an escapement wheel and lever;
one or more reduction gears;
a spiral spring;
a primary gear; and
a pinion gear.

11. The implantable distraction osteogenesis device of claim 10 , wherein:
the guide comprises a plurality of teeth; and
the pinion gear of the regulator engages the plurality of teeth.

12. An implantable distraction osteogenesis device comprising:
a guide;
a first bone attachment device slidably engaged with the guide;
a force delivery mechanism coupled to the first bone attachment device and operably engaged with the guide;
a regulator operably engaged with the force delivery mechanism; and
a second bone attachment device rigidly fixed to the guide, wherein:
the force delivery mechanism is configured to exert a force to move the first bone attachment device along the guide at a predetermined rate;
the regulator is configured to control the force delivered to the first bone attachment device by the force delivery mechanism thereby controlling movement of the first bone attachment device along the guide without percutaneous intervention, and wherein the distraction osteogenesis device is totally subcutaneously implantable and is absent a percutaneous attachment for externally manipulating an internal portion of the device; and
the regulator is configured to control movement of the first bone attachment device along the guide without percutaneous intervention for a period in a range of 1 to 90 days.

13. A method of causing distraction osteogenesis in a bone of a subject in need of such therapy, the method comprising:
(a) providing an implantable distraction osteogenesis device comprising:
a guide;
a first bone attachment device slidably engaged with the guide;
a force delivery mechanism coupled to the first bone attachment device and operably engaged with the guide;
a regulator operably engaged with the force delivery mechanism wherein the regulator comprises a centrifugal regulator; and
a second bone attachment device rigidly fixed to the guide, wherein:
the force delivery mechanism is configured to exert a force to move the first bone attachment device along the guide at a predetermined rate; and
the regulator is configured to control the force delivered to the first bone attachment device by the force delivery mechanism thereby controlling movement of the first bone attachment device along the guide without percutaneous intervention;

(b) securing the first bone attachment device and the second bone attachment device to the bone of the subject, wherein the distraction osteogenesis device is completely subcutaneously implanted and is absent a percutaneous attachment for externally manipulating an internal portion of the device; and
(c) actuating the distraction osteogenesis device thereby causing a distraction force to be applied between the first bone attachment device and the second bone attachment device, wherein the distraction osteogenesis device operates without percutaneous intervention after actuation.

14. The method of claim 13 , wherein the distraction osteogenesis device is operated for a period of time sufficient to enable a predetermined amount of distraction osteogene

Assignees

• Univ Oklahoma

Inventors

• El Amm Christian A

Classifications

• A61B17/8009

  the plate having a ratchet · CPC title

• A61B2017/681

  Alignment, compression, or distraction mechanisms · CPC title

• A61B17/663

  for jaw bones, e.g. subcutaneous distractors with external access (periodontal bone regeneration A61C8/0006) · CPC title

• A61B2017/00039

  Electric or electromagnetic phenomena other than conductivity, e.g. capacity, inductivity, Hall effect · CPC title

• A61F2002/768

  for measuring battery status · CPC title