US-12616505-B2 - Accordion maneuver with a bone fixation device

Abstract

A control system for use with an adjustable bone fixation device including a first fixation element and a second fixation element connectable to bone tissue portions on either side of a treatment site, the control system including: one or more actuators configured to controllably adjust lengths of a plurality of adjustable length struts of the bone fixation device, the plurality of adjustable length struts connecting the first and the second fixation elements of the bone fixation device, length adjustment thereof changing a spatial relationship between the first and the second fixation elements; and circuitry configured to control the one or more actuators to cause the first and second fixation elements to perform an accordion maneuver by performing a plurality of actuations to adjust lengths of the plurality of adjustable length struts to create a reciprocal movement of the first and second fixation elements relative to each other.

Inventors

• Shahar Harari
• Oren Cohen
• Michael Wahl
• Scott P. Lavoritano
• Albert A. Montello

Assignees

• SYNTHES GMBH

Dates

Publication Date

20260505

Application Date

20240726

Claims (20)

1. 1 . A control system for use with an adjustable bone fixation device including a first fixation element and a second fixation element connectable to bone tissue portions either side of a treatment site, the control system comprising: one or more actuators configured to controllably adjust lengths of a plurality of adjustable length struts of the bone fixation device, the plurality of adjustable lengths struts connecting said first and said second fixation elements of the bone fixation device, wherein length adjustment thereof changes a spatial relationship between said first and said second fixation elements; and circuitry configured to control said one or more actuators to cause said first and second fixation elements to perform an accordion maneuver by performing a plurality of actuations to adjust lengths of said plurality of adjustable length struts to create a reciprocal movement of said first and second fixation elements relative to each other.
2. 2 . The control system according to claim 1 , wherein said one or more actuators comprise a plurality of actuators, each actuator of said plurality of actuators configured to controllably adjust a length of a strut of said plurality of adjustable length struts.
3. 3 . The control system according to claim 2 , wherein said circuitry is configured to create said reciprocal movement by controlling at least two actuators of said plurality of actuators to simultaneously adjust the length of at least two associated struts to move said first and said second fixation elements relative to each other.
4. 4 . The control system according to claim 3 , wherein said reciprocal movement of said first and second fixation elements comprises an expansion of a distance between the first and second fixation elements and a contraction of the distance between the first and second fixation elements, and wherein said reciprocal movement of said first and second fixation elements is configured to provide a reciprocal movement to said bone tissue portions.
5. 5 . The control system according to claim 1 , wherein said circuitry is configured to: receive a model including spatial relationships between at least said bone tissue portions, said plurality of adjustable length struts, and said first and said second fixation elements; and control said plurality of actuations to provide said reciprocal movement to said bone tissue portions, based on said spatial relationships.
6. 6 . The control system according to claim 5 , wherein said first fixation element is configured to be anchored to bone tissue by at least two first rigid connectors that are configured to extend from the fixation element into bone tissue, where said first fixation element and said at least two first rigid connectors are sized and shaped such that and connection between said first fixation element and said at least two first rigid connectors is such that said rigid first connectors are configured to extend into said bone tissue from different approach angles; wherein said spatial relationships include spatial relationships between said at least two first rigid connectors, said plurality of adjustable length struts, and said first and said second fixation elements.
7. 7 . The control system according to claim 6 , wherein said reciprocal movement comprises oscillating movement of said first and second fixation elements relative to each other.
8. 8 . The control system according to claim 6 , wherein said plurality of actuations includes a repeating pattern of strut actuations, where repetition is at a frequency of 1-3 Hz to mimic physiological forces experienced by bone tissue during walking.
9. 9 . The control system according to claim 6 , wherein said plurality of actuations are such that said spatial relationship between said first and second fixation elements is the same prior to said plurality of actuations and after said plurality of actuations, which plurality of actuations are configured to maintain said bone tissue in an initial position.
10. 10 . The control system according to claim 1 , wherein at least one of said plurality of actuations adjusts said spatial relationship to be configured to apply tensile force to bone tissue at a treatment site, wherein at least one of said plurality of actuations adjusts said spatial relationship to be configured to apply compressive force to said bone tissue at said treatment site.
11. 11 . The control system according to claim 1 , wherein said control system comprises one or more sensors configured to generate one or more sensor signals comprising one or more of: a first sensor signal indicative of an axial force applied by one or more adjustable length struts of said plurality of adjustable length struts during one more of said plurality of actuations or bone positioning actuations; and a second sensor signal of said one or more sensor signals is indicative of a change in dimension of one or more adjustable length struts of said plurality of adjustable length struts during one or more of said plurality of actuations or said bone positioning actuations.
12. 12 . The control system according to claim 11 , wherein said circuitry is configured to one or more of: control one or more of said plurality of actuations or said bone positioning actuations based on said one or more sensor signals; or determine one or more tissue features, based on said one or more sensor signals.
13. 13 . The control system according to claim 12 , wherein said tissue features comprise whether bone movement has occurred during an actuation.
14. 14 . The control system according to claim 12 , wherein said circuitry is configured to perform one or more of said plurality of actuations until said one or more sensor signals produced by said one or more sensors reaches a threshold value.
15. 15 . The control system according to claim 12 , wherein said circuitry is configured to determine, from said one or more sensor signals: an amplitude of the change in dimension of the one or more adjustable length struts; and a speed of the change in dimension of the one or more adjustable length struts.
16. 16 . An adjustable bone fixation device comprising: a first fixation element; a second fixation element; a plurality of adjustable length struts; and a control system comprising: one or more actuators configured to controllably adjust lengths of a plurality of adjustable length struts of the bone fixation device, the plurality of adjustable length struts connecting said first and said second fixation elements of the bone fixation device, wherein length adjustment thereof changes a spatial relationship between said first and said second fixation elements; and circuitry configured to control said one or more actuators to cause said first and second fixation elements to perform an accordion maneuver by performing a plurality of actuations to adjust the lengths of said adjustable length struts to create a reciprocal movement of said first and second fixation elements relative to each other; wherein planes of said first and said second fixation elements are configured to be orientated generally orthogonally to a central longitudinal axis of bone tissue; and wherein said first and said second fixation elements are sized and shaped to be configured to externally surround at least a third of a cross sectional circumference of said bone tissue, said cross section taken perpendicular to said central longitudinal axis.
17. 17 . A method of treatment comprising: connecting a first fixation element and a second fixation element of an adjustable bone fixation device to different portions of bone tissue, on either side of a treatment site, the first and second fixation elements connected by a plurality of adjustable length rigid struts, adjustable by actuation of one or more actuators; and automatically actuating said one or more actuators a plurality of times to reciprocally adjust lengths of said plurality of adjustable length rigid struts to perform an accordion maneuver where said first and said second fixation elements move reciprocally relative to each other.
18. 18 . The method according to claim 17 , comprising: receiving one or more measurement signals indicative of axial forces applied by said plurality of adjustable length rigid struts, during said automatically actuating; and determining one or more tissue parameters, based on said one or more measurement signals.
19. 19 . The method according to claim 18 , wherein said determining comprises: receiving a three-dimensional (3D) model depicting spatial relationships between said different portions of bone tissue and one or more portions of the adjustable bone fixation device; identifying, from the plurality of adjustable length rigid struts, an adjustable length rigid strut most axially aligned with a treatment site on the bone tissue based on the 3D model; and determining said one or more tissue parameters based on a measurement signal of said one or more measurement signals, which measurement signal is associated with said adjustable length rigid strut most axially aligned with said treatment site.
20. 20 . The method according to claim 18 , wherein said one or more tissue parameters comprise a measure of ossification of tissue at said treatment site; wherein the method comprises: evaluating said measure of ossification; and generating an indication as to whether bone tissue is sufficiently healthy to: initiate or resume bone repositioning; or remove the adjustable bone fixation device.

Description

RELATED APPLICATIONS This application is a US Utility Patent Application, which claims the benefit of priority of under 35 USC § 119(e) of IL Patent Application No. 305408 filed 22 Aug. 2023, the contents of which are incorporated by reference as if fully set forth herein in its entirety. TECHNOLOGICAL FIELD The present disclosure, in some embodiments, thereof, relates to performing of accordion maneuver/s in bone treatment and, more particularly, but not exclusively, to performing of accordion maneuver/s in distraction osteogenesis treatment using a bone fixation device. BACKGROUND ART Background art includes; Makhdom A M, Cartaleanu A S, Rendon J S, Villemure I, Hamdy R C. The Accordion Maneuver: A Noninvasive Strategy for Absent or Delayed Callus Formation in Cases of Limb Lengthening. Adv Orthop. 2015; 2015:912790. doi: 10.1155/2015/912790. Epub 2015 Oct. 19. Which discloses “The distraction osteogenesis (DO) technique has been used worldwide to treat many orthopedic conditions. Although successful, absent or delayed callus formation in the distraction gap can lead to significant morbidities. An alternate cycle of distraction-compression (accordion maneuver) is one approach to accelerate bone regeneration. The primary aim of our study is to report our experience with the accordion maneuver during DO and to provide a detailed description of this technique, as performed in our center. The secondary aim is to present a review of the literature regarding the use of accordion maneuver. We reviewed the database of all patients undergoing limb lengthening from the year of 1997 to 2012. Four patients (6.15%) out of 65 showed poor bone regenerate in their tibiae and therefore accordion maneuver was applied for a mean of 6.75 weeks. Of these, three patients have had successful outcome with this technique. The literature showed that this technique is successful approach to trigger bone healing. However, details of how and when to apply this combination of distraction-compression forces were lacking. In conclusion, the accordion technique is safe noninvasive approach to promote bone formation, thus avoiding more invasive surgical procedures in cases of poor callus formation in limb lengthening.” Additional background art includes International Patent Application Publication No. WO2022024133A8, US Patent No. U.S. Ser. No. 11/076,801, US Patent Application Publication No. US20220346846, “Automated continuous distraction osteogenesis system for limb lengthening and reconstruction” to Yiyuan Fu et al, IPEM-Translation, Volume 5, 2023, 100016, ISSN 2667-2588, and “Novel approach to estimate distraction forces in distraction osteogenesis and application in the human lower leg” to Bachmeier et al, Journal of the Mechanical Behavior of Biomedical Materials, Volume 128, 2022, 105133, ISSN 1751-6161. Acknowledgement of the above references, each of which is hereby incorporated by reference in its entirety, is not to be inferred as meaning that these are in any way relevant to the patentability of the presently disclosed subject matter. GENERAL DESCRIPTION Following is a non-exclusive list of some exemplary embodiments of the disclosure. The present disclosure also includes embodiments which include fewer than all the features in an example and embodiments using features from multiple examples, even if not listed below. Example 1. A control system for use with an adjustable bone fixation device including a first fixation element and a second fixation element connectable to bone tissue portions either side of a treatment site; the control system comprising:one or more actuator configured to controllably adjust lengths of a plurality of adjustable length struts of the bone fixation device, the struts connecting said first and said second fixation elements of the bone fixation device, length adjustment thereof changing a spatial relationship between said first and said second fixation elements; andcircuitry configured to control said one or more actuator to cause said first and second fixation element to perform an accordion maneuver by performing a plurality of actuations to adjust lengths of said adjustable length struts to create a reciprocal movement of said first and second fixation elements relative to each other. Example 2. The control system according to Example 1, wherein said one or more actuator comprises a plurality of actuators, each actuator of said plurality of actuators configured to controllably adjust a length of a strut of said plurality of adjustable length struts. Example 3. The control system according to Example 2, wherein said circuitry is configured to create said reciprocal movement by controlling at least two actuators of said plurality of actuators to simultaneously adjust length of at least two associated struts to move said first and said second fixation elements relative to each other. Example 4. The control system according to any one of Examples 1-3, wherein said reciprocal movement of said first