Granted Patent B2

US 9,737,347 · App. 11/299,337 · Granted Aug 22, 2017

Abstract

Claims (30)

1. An intramedullary nail comprising:

an elongate body having a longitudinal central axis and formed of a material M having a tensile strength F z , compressive strength F d , density ρ 2 and modulus of elasticity E;

at least one transverse bore extending transversely to the central axis from a first end to a second end, the transverse bore having a cross-section F and a transverse axis, the transverse bore including a first tapered region tapering from a first diameter at the first end to a second reduced diameter toward a center region of the transverse bore; and

an insert formed of a bioabsorbable material configured and dimensioned for removable insertion into the transverse bore, wherein the transverse bore is manufactured with a size and shape selected to permit insertion of the insert thereinto such that a central bore of the insert is coaxial with the transverse axis, the insert extending from a first end to a second end along a longitudinal axis and including a tapered portion at the first end conforming to dimensions of the tapered region of the transverse bore to hold the insert in position within the transverse bore, the insert including a central bore coaxial with the transverse axis.

2. The device of claim 1 , wherein the insert is formed of a material m having a modulus of elasticity e<E.

3. The device of claim 2 , wherein the modulus of elasticity of the insert, e<0.8 E.

4. The device of claim 2 , wherein the material m has a tensile strength f z <F z .

5. The device of claim 2 , wherein the material m has a compressive strength f d <F d .

6. The device of claim 2 , wherein the density ρ 1 of material m is less than the density ρ 2 of material M.

7. The device of claim 1 , wherein the transverse cross-section F of the transverse bore has a maximum length a in the direction of the central axis and a maximum width b perpendicular to the length a, the intramedullary nail has a diameter D at the transverse bore, and the insert has a length L in the direction of its longitudinal axis that satisfies the condition L>0.2 D.

8. The device of claim 7 , wherein the insert has a length L>0.5 D.

9. The device of claim 7 , wherein the transverse bore in the nail has a substantially circular cross-section F, with maximum lengths a=b.

10. The device of claim 7 , wherein the transverse bore in the nail has a substantially slotted cross-section F, where the maximum length a>b.

11. The device of claim 1 , wherein the insert has substantially the same shape as the transverse bore.

12. The device of claim 1 , wherein the bioabsorbable material includes one of a polyethylene, a high-molecular polyethylene (HMWPE), and another biocompatible synthetic material.

13. The device of claim 1 , wherein the bioabsorbable material is one of a polymer and a copolymer.

14. The device of claim 1 , further comprising a locking screw adapted for insertion through the insert in the transverse bore, the locking screw having a shaft with an outer diameter d satisfying the conditions a>d<b.

15. The device of claim 1 , wherein the nail has an outer surface adjacent the transverse bore, and the transverse bore expands towards the first end adjacent to the outer surface of the nail to form a depression in the outer surface of the nail.

16. The device of claim 1 , wherein the insert is a pin.

17. The device of claim 1 , wherein the transverse bore further comprises a second tapered region tapering from the first diameter at the second end of the transverse bore to the second reduced diameter toward the center region of the transverse bore.

18. An intramedullary nail comprising:

an elongate body having a longitudinal central axis and an outer surface;

at least one transverse bore extending transversely to the central axis from a first end to a second end, the transverse bore having a cross-section F and having a tapered region expanding from a first diameter at a center region thereof towards a second diameter toward the first end adjacent to the outer surface of the nail to form at least one depression in the outer surface of the nail; and

an insert formed of a bioabsorbable material configured and dimensioned for removable insertion into the transverse bore, the insert having a longitudinal axis, a central bore formed along the longitudinal axis and coaxial with the transverse bore, the insert extending from a first end to a second end and including a tapered portion at the first end conforming to dimensions of the tapered region of the transverse bore to hold the insert in position within the transverse bore, wherein the transverse bore is manufactured with a size and shape selected to permit insertion of the insert thereinto;

wherein the insert is formed of a material m having a modulus of elasticity e less than the modulus of elasticity E of the nail.

19. A method for repairing bone fractures comprising:

introducing an intramedullary nail within the medullary canal of a bone, the intramedullary nail having an elongate body with a longitudinal central axis and at least one transverse bore extending transversely to the central axis, the transverse bore having a cross-section F and a transverse axis;

inserting an insert formed of a bioabsorbable material into the transverse bore of the nail, the insert having a longitudinal axis, a central bore formed along the longitudinal axis and coaxial with the transverse axis, and a projection provided on an outer surface of the insert for engaging the nail body adjacent to the transverse bore and holding the insert in position within the transverse bore, wherein the transverse bore is manufactured with a size and shape selected to permit insertion of the insert thereinto; and

introducing a fixation element through the central bore of the insert and the transverse bore of the nail to lock the nail in position,

wherein the insert is formed of a material m having a modulus of elasticity e less than the modulus of elasticity E of the nail.

Assignments (6)