阅读说明：本技术 有效的骨和关节稳定装置特征 (Effective bone and joint stabilization device features ) 是由 K.A.斯特科 F.P.贝金 C.卡斯特罗 W.N.奥尔德里奇 于 2018-07-11 设计创作，主要内容包括：描述用于骨和关节稳定装置或系统的构件以及制造或组装和/或使用的相关联方法。该构件包括用于装置导引、将远侧锚固脚或带螺纹的螺钉附接到伸长弹簧型部件的特征、用于在接合于头内时稳定伸长部件的位置的锚固头特征,和/或用于张紧本装置的数字或电子方法。(Components for bone and joint stabilization devices or systems and associated methods of manufacture or assembly and/or use are described. The means includes features for device guidance, attachment of a distal anchoring foot or threaded screw to the elongated spring-type member, anchoring head features for stabilizing the position of the elongated member when engaged within the head, and/or digital or electronic methods for tensioning the present device.)

1. A medical device, the medical device comprising:

an elongate spring member comprising a plurality of transverse beams and a longitudinal extension from a distal region of the beams, a distal end of the transverse extension comprising an aperture;

an anchor foot comprising a first end, a second end, and a pivot bore therebetween; and

a pin received by the aperture in the longitudinal extension and an anchor foot pivot hole.

2. The medical device of claim 1, wherein the longitudinal extension is twisted 90 degrees.

3. The medical device of claim 1, wherein a proximal surface of the foot is aligned with a face of the elongate spring member when the anchoring foot is pivoted for deployment.

4. The medical device of claim 3, wherein the longitudinal extension is inserted from an outer region of the beam and has a length to engage at least a portion of an end of the anchoring foot inside the outer region when the anchoring foot is pivoted to align with the longitudinal extension.

5. The medical device of claim 4, wherein the transverse beam is orthogonal to an axis of the elongate spring member.

6. The medical device of claim 1, further comprising an anchor head engaged with the beam.

7. The medical device of claim 1, wherein the anchoring head and feet comprise a PEEK polymer material.

8. The medical device of claim 6, wherein the anchoring head comprises two teeth directly opposite each other and a side slot configured to constrain movement of an elongate spring member therebetween.

9. The medical device of claim 8, wherein the teeth are carried by a support post that includes a substantially vertical inner surface and that works with the side slots to constrain movement of the elongate spring member.

10. The medical device of claim 1, wherein the anchoring foot is secured by a pair of bosses extending from a proximal surface of the foot.

11. The medical device of claim 10, wherein each boss is covered with a full radius.

12. The medical device of claim 10, wherein each boss is covered by an inwardly angled or curved fin.

13. A medical device, the medical device comprising:

an anchoring head comprising first and second teeth configured for unidirectional advancement and locking with a spring member when received by the anchoring head, the teeth being directly opposed to each other, each tooth being supported by a deflectable support post connected to a body of the anchoring head adjacent a bottom surface of the anchoring head;

the body of the anchoring head includes a slot configured to hold the spring in a stable fore-aft position between the teeth with the post; and

the support posts each have an inner surface that is within about 5 degrees of the vertical axis of the body to work with the slot to constrain the movement of the spring member.

14. The medical device of claim 13, wherein an anterior-posterior gap of about 0.005 inches or less is provided by the slot for the spring member.

15. The medical device of claim 13, wherein the anchor head includes only the first and second teeth.

16. The medical device of claim 13, wherein the inner surface of each support post has a length that is at least about 40% of the overall height of the anchor head.

17. The medical device of claim 13, wherein the anchor head comprises a PEEK polymer material and the stable anterior-posterior position is along a centerline between the teeth.

18. The medical device of claim 13, wherein each tooth is configured to contact the elongate member at an initial contact angle between about 20 and about 30 degrees, wherein the initial contact angle transitions to a mid-tooth angle between about 40 and about 60 degrees.

19. The medical device of claim 18, wherein each tooth terminates in an entire rounded corner at the upper end.

20. The medical device of claim 18, wherein the transition is between the initial contact angle and the middle tooth angle on a rounded corner.

21. A medical device, the medical device comprising:

an anchoring head comprising first and second teeth, the teeth configured for unidirectional advancement and locking with a spring member when received by the anchoring head, the teeth directly opposed to each other;

each tooth is supported by a deflectable support post connected to the body of the anchor head adjacent the bottom surface of the anchor head, the support posts each having an inner surface configured to constrain the fore-aft position of the spring member;

each tooth is configured to contact the elongated member at an initial contact angle between about 20 and about 30 degrees, wherein the initial contact angle transitions to a mid-tooth angle between about 40 and about 60 degrees.

22. The medical device of claim 21, wherein each tooth terminates in an entire rounded corner at the upper end.

23. The medical device of claim 21, wherein the transition is between the initial contact angle and the middle tooth angle on a rounded corner.

24. The medical device of claim 21, wherein the body of the anchor head includes a slot configured to constrain the back and forth movement of the spring member.

25. The medical device of claim 24, wherein an anterior-posterior gap of about 0.005 inches or less is provided by the slot for the spring member.

26. The medical device of claim 21, wherein the inner surface of the support post is disposed at about 5 degrees to being parallel to a vertical axis of the body.

27. The medical device of claim 21, wherein the medical device includes only the first and second teeth.

28. The medical device of claim 21, wherein the inner surface of each support post has a length that is at least about 40% of the overall height of the anchor head.

29. The medical device of claim 28, wherein the anchor head comprises a PEEK polymer material and the anterior-posterior location is along a centerline between the teeth.

30. The medical device of any one of claims 13-21, further comprising the spring member, the spring member including an end that is non-tapered or rounded.

31. A medical device, the medical device comprising:

an elongate spring member, the elongate spring member comprising: a first section comprising a plurality of cells including deflectable transverse beams connected at an outer region; and a second section with no said unit.

32. The medical device of claim 31, wherein the second section is configured as an introducer needle.

33. The medical device of claim 31, wherein the second section is a tab comprising an eyelet.

34. The medical device of claim 33, further comprising a needle attached to the elongate spring member, wherein at least one suture passes through the eyelet.

35. The medical device of claim 33, wherein the tab is received within a transverse slot of a screw head and secured in place by the eyelet.

36. The medical device of claim 33, wherein the tab extends at least about 1mm above a face of the screw to provide a driver interface.

37. The medical device of claim 31, wherein the second section is a tab securely received within a slot in a screw head, and wherein the tab extends at least about 1mm above a face of the screw to provide a driver interface.

38. A medical device, the medical device comprising:

an elongate spring member;

proximal and distal anchors engaged with the elongate spring member; and

at least one suture passing through each anchor.

39. The medical device of claim 38, wherein the elongate spring member comprises a plurality of transverse beams connected at an outer region to form a unit,

wherein at least one of the anchors comprises at least one tooth that engages the unit under tension of the spring member; and is

Wherein the at least one wire is bound into a ring.

40. A method of tensioning a medical device including an elongate spring member under tension between a proximal anchor and a distal anchor, the method comprising:

measuring an effective length of the elongate spring member between the anchors;

perturbing an end of the elongate member extending through one of the anchors;

measuring a vibration frequency at one of the anchors;

calculating, with a processor, an estimated tension value based on the measured vibration frequency and with reference to the calibration data; and

outputting, from the processor, an indication of the estimated tension value.

41. The method of claim 40, wherein the output indicates at least one of a proper tension and an over-tension.

42. The method of claim 40, wherein the output is a device tension or compression value estimate.

43. The method of claim 40, wherein the calibration data is stored in a non-transitory memory that also stores instructions for causing the processor to calculate the estimated tension value based on the measured vibration frequency and with reference to calibration data.

Technical Field

The embodiments described herein relate to the field of surgery and are more particularly useful in bone fusion, joint stabilization and/or fracture fixation procedures.

Background

Various devices are used in orthopedic surgery for bone fusion and/or joint stabilization. Bone screws, staples and plates are used as a rigid option for the set. Number 4,959,064; 6,656,184, respectively; 7,833,256, respectively; 7,985,222, respectively; 8,048,134, respectively; 8,449,574 and 8,491,583 and U.S. publication No. 2006/0264954 describe examples of screw-type devices with incorporated tensioning springs or components. Button and suture type devices provide more flexible grouping options, examples of which are numbered 7,235,091; 7,875,057 and 8,348,960. However, the foregoing examples have many deficiencies, and there is a need to address these deficiencies and others.

Disclosure of Invention

Provided herein are exemplary embodiments of bone and/or joint stabilization devices that may be tensioned during a medical procedure to remain effective in maintaining compression of a subject's anatomy (anatomi) during use. In many embodiments, an orthopedic surgical device or system includes an elongated member or body, optionally including a spring pattern (pattern) having a plurality of beams that each include a cross-member that is free to deflect upon axially stretching the elongated body. The anchor head may receive the elongated body and may secure it with a one-way (e.g., ratchet) interface. Two such anchors may be used, or one such anchor may be used with a deployable foot or screw anchor used to anchor opposite ends of the elongate body. The details of the elongated spring member and the anchor head and foot features are further set forth in U.S. publication No. 2016/0213368 ("Active Tension Bone and Joint Stabilization Devices") and international publication No. WO 2016/122944 ("Active Tension Bone and Joint Stabilization Devices"), both of which are incorporated herein by reference in their entirety for all purposes. Suitable methods that are also suitable for medical use in the present embodiments are described with respect to fig. 8-15 of the incorporated U.S. publication No. 2016/0213368 and international publication No. WO 2016/122944.

Many of the embodiments described herein include optional elongated spring member features and optional aspects (e.g., attachment features) associated with the anchoring head, anchoring foot, and screw-type anchor. Digital or electronic tensioning method and system embodiments are also described.

The various assembly portions may be provided in a kit in a packaged combination for access by a medical professional. The elongate spring member may be loaded in a sheath with a portion of the anchor foot to position the anchor foot in alignment with the elongate body for implantation. In creating the final assembly (e.g., performed in situ by a physician), the elongate spring member or body may be received at the proximal end by the anchor head. One or more teeth in the anchoring head may be engaged with the elongated spring member and advanced relative to the spring member or body until it is stretched to a desired tension. May engage the teeth of a through hole in the elongate spring member or body. Finally, in methods of using and/or manufacturing the final implant configuration, the elongated spring member may be trimmed to length with a flush cutter or custom unit.

In summary, the present devices or systems, kits (with or without components) in which they are included, methods of use (e.g., in the case of implantation, in repair during patient treatment and/or for system removal), and manufacture (including assembly of the various components by a technician prior to sale or during a medical procedure by a surgeon (as applicable)) are all included within the scope of the present disclosure.

Drawings

The details of the subject matter set forth herein, both as to its structure and operation, may be apparent by study of the accompanying drawings, in which like reference numerals refer to like parts. The components in the figures are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the subject matter. The illustrations are intended to convey concepts, where relative sizes, shapes and other detailed attributes may be schematically (more precisely) or precisely shown. Scaled features (e.g., such as from engineering drawings and/or photographs) may be relied upon as a prerequisite for claim support.

Fig. 1A-1C are side perspective views of various exemplary embodiments of the present medical device or system.

Fig. 2A and 2B are perspective detail and cross-sectional views, respectively, of an exemplary embodiment of an elongated spring member and anchoring head configuration.

FIG. 3 is a face or top view of a segment of an exemplary embodiment of an elongate spring member pattern.

Fig. 4A-4C are top, bottom and side cross-sectional (with details) views of the exemplary embodiment of the anchoring head shown in fig. 2A and 2B, respectively.

Fig. 5A and 5B are perspective views of different anchoring foot embodiments.

Fig. 6 is an end view of the same pieces shown in fig. 5A and 5B overlaid on one another.

FIG. 7 is a flow chart of an exemplary embodiment of a method for a digital tensioning system.

Fig. 8 is a top view of an exemplary embodiment of an elongate spring member including an integral introducer.

Fig. 9 is a top view of an exemplary embodiment of an elongate spring member including a sacrificial tab with an eyelet for attachment of a needle or stylet introducer, also shown.

FIG. 10A is a side assembly view of the distal end of an exemplary embodiment of a system with an elongated spring member including a distal tab fitted into and secured with a screw head; fig. 10B is a face or top view of the distal end of the fig. 10A structure.

Fig. 11 is a side or top view of an exemplary embodiment of a hybrid spring component/stitched button device.

Detailed Description

Various exemplary embodiments are shown in the drawings and described further below. Reference is made to these examples in a non-limiting sense, as it is noted that they are provided to illustrate more broadly applicable aspects of the devices, systems, and/or methods. Various changes may be made to the embodiments without departing from the true spirit and scope of the embodiments, and equivalents may be substituted. In addition, many modifications may be made to adapt a particular situation, material, composition of matter, process action or steps, to the objective, spirit or scope of the present invention. All such modifications are intended to be within the scope of the claims that may be presented herein.

The method (including the method of use and/or manufacture) may be performed in any order of events that is logically possible, and in any stated order of events. Medical methods may include any of the activities of hospital personnel associated with device preparation (provision), implant guidance, positioning and/or repositioning, and surgical access, closure and/or removal (e.g., as during an implantation procedure).

Exemplary embodiments

The exemplary embodiment 100 in fig. 1A includes an elongated spring member or body 10 in the form of a stretchable or spring-type architecture that includes a plurality of beams or beam members 12. The beams 12 may each comprise a cross member that is free to deflect for axially stretching the spring member. In the spring version, the transverse bars 14 are provided at an outer area (extension) connector 16 of each beam in opposing pairs joined to each other. Each such connector 16 may be a curved continuation or otherwise configured of each rod 14 or beam 12 (e.g., as described in connection with fig. 3). Each pair of beams 12 is connected to an axially adjacent pair by an inboard connector or bridge 18. The beam 12 or beam pair acts as a series connected leaf spring element arranged in the unit 20.

The embodiments 110 and 120 of fig. 1B and 1C include similar spring member sections 112 and 122, respectively. These embodiments also each include longitudinally extending sections 114 and 124. For each of embodiments 110 and 120, the spring and the axially or longitudinally extending section together define the entire elongate body 116 and 126, respectively.