IP Library › Granted Patent US 12,611,316
Granted Patent B2
US 12,611,316 · App. 19/278,532 · Granted Apr 28, 2026

Intervertebral members and methods of using a bone reinforcing composition for retaining the intervertebral members

Inventor: Mark Frenkel (Naples, FL)
Assignee: FutureSpine Inc.
A61F2/4601A61B17/8841A61F2/2846A61F2/442A61F2002/285A61F2002/30062A61F2002/30317A61F2002/3092A61F2002/4631
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Quick Facts
Patent No.
US 12,611,316
App. No.
19/278,532
Granted
Apr 28, 2026
Kind
B2
Abstract

A method for dispensing a bone reinforcement composition into an intervertebral spacer and at least one adjacent vertebra can help retain the implant in situ. A cannula guide is inserted into a first vertebra guided by a live imaging system. A curved directional composition delivery cannula is inserted through a tubular body of the guide; then positioning the delivery cannula along a desired path, positioning an end using a curved end as a steering mechanism. The delivery cannula passes through a first vertebra, into the intervertebral spacer, and optionally into a second vertebra. A volume of reinforcement composition is dispensed using cyclical steps of incrementally withdrawing the delivery cannula and dispensing of the reinforcement composition until the path is filled with reinforcement composition stabilizing the respective vertebrae and/or interbody devices relative to each other. In an alternate arrangement, the cannula is inserted through a guide integrated into the spacer.

Claims (76)

1 . A method of employing a bone reinforcing material to retain an intervertebral spacer in position between two adjacent vertebrae, the method comprising:

placing the intervertebral spacer in position between two adjacent vertebrae;

after placing the intervertebral spacer between the two adjacent vertebrae,

moving a hollow anchor though the intervertebral spacer and into one vertebra of the two adjacent vertebrae;

inserting a cannula through a portion of the hollow anchor positioned within the one vertebra of the two adjacent vertebrae; and

dispensing a volume of a bone reinforcement composition through the cannula;

withdrawing the cannula, which is located in the hollow anchor, and dispensing at least a portion of the volume of the bone reinforcement composition from the cannula into the one vertebra of the two adjacent vertebrae during the withdrawing process; and

removing the cannula from the hollow anchor.

2 . The method of claim 1 , further comprising a step of the bone reinforcement composition setting, wherein the set bone reinforcement composition anchors the intervertebral spacer in situ between the two adjacent vertebrae.

3 . The method of claim 1 , wherein the step of withdrawing the cannula and dispensing the volume of the bone reinforcement composition is accomplished in repeating steps of withdrawing the cannula a short distance, stopping the withdrawal, and dispensing the volume of the bone reinforcement composition.

4 . The method of claim 1 , further comprising

inserting a cannula guide instrument into position for dispensing the bone reinforcement composition, and

passing the cannula through the cannula guide instrument for dispensing the bone reinforcement composition therethrough.

5 . The method of claim 4 , wherein the cannula guide instrument includes a linear tubular element of sufficient strength to penetrate bone.

6 . The method of claim 1 , wherein the intervertebral spacer includes at least one cannula guide directed towards a respective adjacent vertebra of the two adjacent vertebrae, and wherein inserting the cannula comprises inserting the cannula through the at least one cannula guide.

7 . The method of claim 1 , wherein the intervertebral spacer includes a porous structure with a porosity gradient, the porosity gradient having a higher porosity in a central region of the intervertebral spacer and a lower porosity near outer surfaces of the intervertebral spacer.

8 . The method of claim 7 , wherein the porosity gradient of the intervertebral spacer may facilitate controlled distribution of the bone reinforcement composition, with the higher porosity central region allowing for greater material flow and the lower porosity outer surfaces providing increased structural support.

9 . A method of employing a bone reinforcing material to retain an intervertebral spacer in position between two adjacent vertebrae of a patient, the method comprising:

delivering bone graft material into a first chamber of the intervertebral spacer;

placing the intervertebral spacer in position between the two adjacent vertebrae, wherein the intervertebral spacer includes a porous structure with a porosity gradient, the porosity gradient having a higher porosity in a central region of the intervertebral spacer and a lower porosity near outer surfaces of the intervertebral spacer;

inserting a cannula in accordance with one of the following:

(a) through one vertebra of the two adjacent vertebrae and at least penetrating into the intervertebral spacer; or

(b) through the intervertebral spacer and at least penetrating one vertebra of the two adjacent vertebrae:

dispensing a volume of a bone reinforcement composition through the cannula, wherein at least a portion of the volume of the bone reinforcement composition is delivered from the cannula being withdrawn such that the bone reinforcing material is delivered into a second chamber of the intervertebral spacer and into each of the respective one vertebra of the two adjacent vertebrae; and

removing the cannula from the patient.

10 . The method of claim 9 , wherein the bone reinforcing material is delivered into the second chamber after the bone graft material has been delivered into the first chamber.

11 . The method of claim 9 , wherein the bone graft material occupies most of the first chamber of the intervertebral spacer, and the bone reinforcing material occupies most of the second chamber.

12 . The method of claim 9 , further comprising

positioning a cannula guide instrument in the one vertebra of the two adjacent vertebrae; and

moving the cannula through the cannula guide instrument to insert the cannula through the one vertebra and/or the intervertebral spacer and at least penetrating one vertebra.

13 . The method of claim 9 , further comprising

inserting a cannula guide instrument into the patient, and

passing the cannula through the cannula guide instrument for dispensing the bone reinforcement composition.

14 . A method comprising:

positioning an intervertebral spacer in position between a first vertebra and a second vertebra of a patient;

delivering a first anchor through the intervertebral spacer and into the first vertebra;

delivering a second anchor through the intervertebral spacer and into the second vertebra, wherein a bifurcate passageway includes

a first passageway extending through the first anchor, and

a second passageway extending through the second anchor; and

selectively delivering, via at least one cannula, a bone reinforcement material along the first passageway and the second passageway such that the bone reinforcement material is delivered into the first vertebra and the second vertebra and extends through a portion of the intervertebral spacer between the first passageway and the second passageway.

15 . The method of claim 14 , further comprising moving proximally the at least one cannula and dispensing a volume of the bone reinforcement material while proximally moving the at least one cannula.

16 . The method of claim 14 , further comprising allowing the bone reinforcement material to set to anchor the intervertebral spacer in situ between the first vertebra and the second vertebra.

17 . The method of claim 14 , wherein the intervertebral spacer has one or more interconnected passageways defining a continuous bone cement flow path along which the bone reinforcement material flows through a porous regions of the intervertebral spacer.

18 . The method of claim 14 , wherein the bone reinforcement material is a bone cement.

19 . The method of claim 14 , wherein the bone reinforcement material is a re-absorbable structural compound.

20 . The method of claim 14 , wherein the bone reinforcement material is a bone graft material.

21 . The method of claim 14 , further comprising dispensing a volume of the bone reinforcement material is accomplished in repeating steps of withdrawing the at least one cannula a short distance, stopping the withdrawal, and dispensing the volume of a bone reinforcement composition.

22 . The method of claim 14 , further comprising

inserting a cannula guide instrument into position for dispensing the bone reinforcement material, and

passing the at least one cannula through the cannula guide instrument for dispensing the bone reinforcement material therethrough.

23 . The method of claim 14 , further comprising viewing a location of the at least one cannula using real time imaging equipment.

24 . The method of claim 14 , wherein the intervertebral spacer includes at least one cannula guide directed towards a respective adjacent vertebra of the first vertebra and the second vertebra, and wherein inserting the at least one cannula comprises inserting the at least one cannula through the at least one cannula guide.

25 . The method of claim 14 , wherein the intervertebral spacer includes a porous structure with a porosity gradient, the porosity gradient having a higher porosity in a central region of the intervertebral spacer and a lower porosity near outer surfaces of the intervertebral spacer.

26 . The method of claim 25 , wherein the porosity gradient of the intervertebral spacer may facilitate controlled distribution of the bone reinforcement material, with the higher porosity central region allowing for greater material flow and the lower porosity outer surfaces providing increased structural support.

27 . A method comprising:

delivering bone graft material into a first chamber of an intervertebral spacer, wherein the intervertebral spacer includes a porous structure with a porosity gradient, the porosity gradient having a higher porosity in a central region of the intervertebral spacer and a lower porosity near outer surfaces of the intervertebral spacer;

positioning an intervertebral spacer in position between two adjacent vertebrae of a patient;

delivering a cannula through the intervertebral spacer and into at least one of the two adjacent vertebrae;

delivering, via the cannula, a bone reinforcement material into the at least one of the two adjacent vertebrae; and

delivering the bone reinforcement material into a second chamber of the intervertebral spacer.

28 . The method of claim 27 , wherein the bone reinforcement material is delivered into the second chamber of the intervertebral spacer after the bone graft material has been delivered into the first chamber of the intervertebral spacer.

29 . The method of claim 27 , wherein the bone graft material occupies most of the first chamber of the intervertebral spacer, and the bone reinforcement material occupies most of the second chamber.

30 . A method comprising:

positioning an intervertebral spacer in position between a first vertebra and a second vertebra of a patient;

after positioning the intervertebral spacer between the first vertebra and the second vertebra,

moving a first hollow anchor through an intervertebral cage of the intervertebral spacer and into the first vertebra,

moving a second hollow anchor through the intervertebral cage and into the second vertebra; and

delivering a bone reinforcement material to form a continuous cement column extending between inside the first vertebra, inside the second vertebra, inside the first hollow anchor and the second hollow anchor, and inside the intervertebral spacer.

31 . The method of claim 30 , wherein the continuous cement column extends through the first hollow anchor, the second hollow anchor, and a portion of the intervertebral cage between the first hollow anchor and the second hollow anchor, thereby rigidly locking together the intervertebral spacer, the first vertebra, and the second vertebra.

32 . The method of claim 30 , further comprising delivering the bone reinforcement material through one or more openings in a sidewall of the first hollow anchor.

33 . The method of claim 30 , wherein the bone reinforcement material flows through a V-shaped portion of the intervertebral spacer.

34 . The method of claim 30 , wherein the intervertebral spacer includes porous region through which the bone reinforcement material flows to form the continuous cement column.

35 . The method of claim 30 , wherein the bone reinforcement material flows through one or more porous regions of the intervertebral spacer to form the continuous cement column.

36 . The method of claim 30 , further comprising

inserting a cannula guide instrument into position for dispensing the bone reinforcement composition, and

passing the cannula through the cannula guide instrument for dispensing the bone reinforcement composition.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 16, 2025
From: FRENKEL, MARK
To: FUTURESPINE INC.
Reel/Frame 072266/0817 →
Continuity (4)
Provisional Application 63827769 · Jun 20, 2025
Provisional Application 63727639 · Dec 3, 2024
Provisional Application 63674778 · Jul 23, 2024
Related Publication 20260026944A1 · Jan 29, 2026
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