Custom in situ formable brace

• US 5,632,723 A
• Filed: 06/02/1995
• Issued: 05/27/1997
• Est. Priority Date: 02/16/1993
• Status: Expired due to Term

• Current Assignee: Ossur hf
• Original Assignee: Royce Medical Company (Ossur hf)
• Inventors: Grim, Tracy E.
• Primary Examiner(s): FLANAGAN, BEVERLY MEINDL
• Application Number:
  US08/459,463
• Time in Patent Office: 725 Days
• Field of Search: 602/6, 602/8, 602/19, 602/14, 2/44, 128/95.1, 128/99.1
• US Class Current: 602/19
• CPC Class Codes: A61F 5/022 consisting of one or more shells

Abstract

A soft-goods type, custom "in situ" formable back brace for supporting a weakened or injured back and/or neck is disclosed having hardenable components which conform to the unique configuration of a patient'"'"'s torso. An initially flexible rear torso component, generally extending circumferentially around the patient'"'"'s back, is releasably coupled to the torso using a plurality of Velcro-type securing straps. Alternatively, an initially flexible front torso component in combination with a rear component may be releasably coupled to a patient'"'"'s torso. Once properly secured, liquid, preferably water, may be introduced into each component to activate the activatable, hardenable material encapsulated therein. Each component may be further comprised of a plurality of panels or pads with elasticized, resilient material interposing adjacent panels. The panels or pads may be permanently or removably integrated into each torso component. Additional supporting strut members may be provided to isolate and minimize upper neck and head movement for patient'"'"'s having severe neck and/or back injuries. The hardenable components may be activated by introduction of water or other suitable liquid through inlet port conduits provided on the exterior surface of each said component. Alternatively, activation of the included pre-polymer impregnated matrix may be accomplished by immersing the hardenable component in liquid. An inflatable pneumatic pad may also be included on one or more component interior surfaces to provide minor fitting adjustment. Additional padding may be included on each component for the patient'"'"'s comfort.

Claims

1. A custom "in situ" formable back brace, comprising:

a back assembly;

said back assembly including (a) a water impervious sealed first enclosure containing a matrix impregnated with an activatable hardenable material and (b) a water impervious sealed second enclosure containing a matrix impregnated with an activatable hardenable material; and

a belt assembly for securing said first and second enclosures against the patient'"'"'s back.

2. The brace of claim 1 wherein said back assembly includes a first fluid inlet port communicable with said first enclosure and a second fluid inlet port communicable with said second enclosure.

3. The brace of claim 1 wherein said first and second enclosures are vertically aligned relative to one another.

4. The brace of claim 1 wherein said back assembly includes resilient material interposed between said first and second enclosures to provide flexibility to said back assembly and custom fit around the patient'"'"'s torso.

5. The brace of claim 1 wherein said first and second enclosures both comprise vertical panels.

6. The brace of claim 1 wherein said first and second enclosures are permanently integrated components of said back assembly.

7. The brace of claim 1 wherein said back assembly includes port means for injecting activating fluid into said first and second enclosures to cause, with said belt means holding said first and second enclosures against the patient'"'"'s back, the activatable materials therein to harden and conform to the unique configurations of the patient'"'"'s back.

8. The brace of claim 1 wherein said belt assembly includes first and second length-adjustable belts both attached to said back assembly and extendible across the front of the patient'"'"'s torso, generally one above the other.

9. The brace of claim 1 wherein said back assembly includes a water impervious sealed third enclosure containing a matrix impregnated with an activatable hardenable material, said belt assembly holding said first, second and third enclosures in a side-by-side arrangement against the patient'"'"'s back.

10. The brace of claim 1 wherein said back assembly is extendible around the front of the patient to encircle the patient'"'"'s torso and held in position by said belt assembly.

11. The brace of claim 10 wherein said back assembly includes a water impervious sealed third enclosure containing a matrix impregnated hardenable material, said belt assembly holding said third enclosure against the front of the patient'"'"'s torso.

12. The brace of claim 11 wherein said back assembly includes resilient material between said third and second enclosures.

13. The brace of claim 1 wherein said belt assembly includes a chest belt positionable across the patient'"'"'s chest and a waist belt positionable across the patient'"'"'s waist.

14. The brace of claim 1 wherein at least a portion of said first enclosure is adjacent to a thoracic part of the patient'"'"'s back.

15. A custom "in situ" formable back brace, comprising:

a back assembly including a water impervious sealed enclosure containing a matrix impregnated with an activatable hardenable material;

said back assembly being positionable in an operative position against a patient'"'"'s back;

at least one belt securing said back assembly in the operative position; and

said enclosure, with said back assembly in the operative position, extends up from the patient'"'"'s waist to the thoracic region of the patient just below the shoulders.

16. The back brace of claim 15 wherein said at least one belt includes patient waist and chest belts.

17. The back brace of claim 15 wherein said back assembly includes a fluid inlet port at the top of said enclosure at an exterior surface thereof.

18. A custom "in situ" formable back brace, comprising:

a brace frame securable in an operative position against a patient'"'"'s back, said back frame having an inward surface;

a panel assembly securable to said inward surface in a secured position and unsecurable therefrom;

said panel assembly including a water impervious sealed enclosure containing a matrix impregnated with an activatable hardenable material; and

with said brace frame in the operative position, said material can be fluid activated to cause said material to harden and conform to the unique shape of the patient'"'"'s adjacent back.

19. The back brace of claim 18 wherein said panel assembly includes a fluid injection port for injecting an activating fluid to activate the material.

20. The back brace of claim 19 wherein said brace frame includes an opening in alignment with said fluid injection port with said panel assembly in the secured position.

21. The back brace of claim 18 further comprising hook-and-loop securing means for releasably securing said panel to said inward surface.

22. The back brace of claim 18 wherein said brace frame includes on said inward surface a recess dimensioned to receive therein said panel assembly in the secured position.

23. The back brace of claim 18 further comprising a patient chest belt and a waist belt attached to said brace frame.

24. The back brace of claim 18 wherein said panel assembly defines a first panel assembly, and further comprising second and third panel assemblies securable to said inward surface on opposite sides of said first panel assembly.

25. A custom "in situ" formable back brace, comprising:

a back assembly adapted to wrap around a patient'"'"'s torso, and having a front torso portion and a back torso portion;

said back assembly including a water impervious sealed first enclosure containing a matrix impregnated with an activatable hardenable material and a water impervious sealed second enclosure containing a matrix impregnated with an activatable hardenable material;

said first enclosure is at said front torso portion and said second enclosure is at said back torso portion; and

a belt assembly for securing said back assembly around the patient'"'"'s torso.

26. The back brace of claim 25 wherein said back assembly includes a first fluid injection port communicable with said first enclosure and a second fluid injection port communicable with said second enclosure.

27. The back brace of claim 25 wherein said belt assembly includes a length-adjustable chest belt and a length-adjustable waist belt.

28. The back brace of claim 25 wherein said back assembly includes resilient material between said first and second enclosures.

29. The back brace of claim 25 wherein said first and second enclosures extend up to the thoracic areas of the patient with said belt assembly securing said back assembly around the patient'"'"'s torso.

30. The back brace of claim 25 wherein said back assembly includes lateral ends of said rear torso portion overlapping lateral ends of said front torso portion.

31. A custom "in situ" formable back brace, comprising:

a brushed nylon layer positionable against a patient'"'"'s body portion;

a first cushioning foam layer adjacent said nylon layer;

fluid-activatable, hardenable material which is encapsulated within a water impervious enclosure and which remains initially pliable until activating fluid is introduced to cause said material to harden and conform to the unique shape of the patient'"'"'s adjacent body portion;

a second cushioning foam layer on a side of said enclosure opposite to that of said first cushioning foam layer; and

an exterior shell covering said second cushioning foam layer.

32. The back brace of claim 31 wherein said enclosure is disposed between said first and second cushioning foam layers.

33. A support brace assembly, comprising:

a supporting belt brace adapted to encircle and to be secured relative to a patient'"'"'s lower torso, said belt brace having an inward surface and through-opening through said inward surface;

a pouch on said inward surface;

a component pad containing a matrix impregnated with an activatable hardenable material, said pad being insertable into said pouch in an operative position with said fluid port operatively accessible, with said supporting belt secured around the lower torso, via said through-opening such that the activating fluid can be injected into said pad to cause the material therein to harden and conform to the unique shape of the patient'"'"'s adjacent lower back region; and

securing tabs attached to said inward surface and releasably securing said pad in the operative position.

34. A custom "in situ" formable back brace assembly, comprising:

a back brace positionable against the patient'"'"'s back;

a shoulder strap, a chest strap, and a waist strap, each attached to said back brace; and

a water impervious sealed enclosure containing a matrix impregnated with an activatable hardenable material supported by said back brace.

35. The back brace assembly of claim 34 wherein said back brace includes spaced upper and lower components and a pair of support struts mounted to said upper and lower components.

36. The back brace assembly of claim 35 wherein said support struts are mounted to said upper and lower components with rivets.

37. The back brace assembly of claim 34 wherein said enclosure defines a lower right enclosure, and further comprising lower left, upper right and lower right enclosures, each supported by said back brace and thereby positionable against respective portions of the patient'"'"'s back, and each containing a matrix impregnated with an activatable hardenable material.

38. The back brace assembly of claim 34 wherein said back brace includes a central vertical cut-out area corresponding to the patient'"'"'s spinal area.

39. The back brace assembly of claim 34 wherein said back brace includes shoulder protrusions to which said shoulder strap is secured, upper protrusions to which said chest strap is secured and lower protrusions to which said waist strap is secured.

40. The back brace assembly of claim 39 further comprising mid-torso securing straps attached to said back brace between said upper and lower protrusions.

41. A custom "in situ" formable brace assembly, comprising:

a front apron dimensioned to generally cover the middle chest and abdominal region of the front torso of a patient;

at least one torso strap attached to said front apron and extendible about the patient'"'"'s torso; and

a water impervious sealed enclosure containing a matrix impregnated with an activatable hardenable material and supported by said front apron to thereby be positioned adjacent to the patient'"'"'s front torso.

42. The brace assembly of claim 41 wherein said material in said enclosure is fluid activated through an injection port and with said enclosure supported by said front apron.

43. The brace assembly of claim 41 wherein said material in said enclosure is fluid activated and subsequently said enclosure is attached to said front apron.

44. A custom "in situ" formable bracing assembly, comprising:

a rear back brace component;

a front apron;

at least one securing strap interconnecting said rear back brace and said front apron around a patient'"'"'s torso; and

fluid-activatable hardenable material contained in an enclosure held in said front apron.

45. The bracing assembly of claim 44 wherein said from apron when positioned with said securing strap on the patient, is generally dimensioned to cover the middle chest and abdominal region of the patient'"'"'s front torso.

46. The bracing assembly of claim 44 wherein said front apron includes an activating-fluid inlet port communicating with said hardenable material.

47. The bracing assembly of claim 44 further comprising fluid-activatable hardenable material contained in said rear back brace component.

48. A head and neck brace assembly, comprising:

a chin support;

a jaw support member connected to said chin support;

a rear skull component connected to said jaw support member;

interconnected front and rear lower torso components;

a front strut connecting said chin support to said front torso component; and

a rear strut connecting said rear skull component to said rear torso component;

wherein said rear skull component includes fluid-activatable hardenable material, hardenable to conform to a patient'"'"'s adjacent rear skull area.

49. A head and neck brace assembly, comprising:

a chin support;

a jaw support member connected to said chin support;

a rear skull component connected to said jaw support member;

interconnected front and rear lower torso components;

a front strut connecting said chin support to said front torso component; and

a rear strut connecting said rear skull component to said rear torso component;

wherein said front torso component includes fluid-activatable hardenable material, hardenable to conform to a patient'"'"'s adjacent front torso area.

50. A head and neck brace assembly, comprising:

a chin support;

a jaw support member connected to said chin support;

a rear skull component connected to said jaw support member;

interconnected front and rear lower torso components;

a front strut connecting said chin support to said front torso component; and

a rear strut connecting said rear skull component to said rear torso component;

wherein said rear torso component includes fluid-activatable hardenable material, hardenable to conform to a patient'"'"'s adjacent rear torso area.

51. A head and neck brace assembly, comprising:

a chin support;

a jaw support member connected to said chin support;

a rear skull component connected to said jaw support member;

interconnected front and rear lower torso components;

a front strut connecting said chin support to said front torso component; and

a rear strut connecting said rear skull component to said rear torso component;

wherein said chin support includes fluid-activatable hardenable material, hardenable to conform to a patient'"'"'s adjacent chin area.