Apparatus and method for fixation of osteoporotic bone

Claim 2

An injection device comprising: a delivery cannulae having a proximal end and a distal end, which are connected by a cannulae body, and a lumen capable of acting as a material conduit, said lumen passing from said proximal end through said distal end; an elongated plunger, said plunger being sized and configured to slidably pass through said lumen so as to force said injectable material through said lumen while permitting air from said lumen to escape proximally past said plunger; a removable handle configured for secure attachment to said proximal end of said delivery cannulae, said delivery cannulae being equipped with a handle retention member integrally formed in said proximal end of said delivery cannulae.

Claim 3

An injection device according to claim 1 , further comprising: an elongated guide wire, said guide wire having a first end and a second end connected by an elongated guide wire body, said first end being configured with a taper, said taper being capable of breaching cortical bone sufficient to form a channel through said cortical bone; and an aligning cannulae having a gripping end and a tapered end, said aligning cannulae being sized and configured to slidably pass circumferentially over said guide wire and said delivery cannulae being sized and configured to slidably pass circumferentially over said aligning cannulae.

Claim 4

An injection device according to claim 2 , wherein said guide wire comprises graduated indicia on said guide wire body.

Claim 5

An injection device according to claim 2 , wherein said delivery cannulae comprises graduated indicia on said cannulae body.

Claim 6

An injection device according to claim 2 , wherein said plunger comprises a first end having a gripping member, said first end being connected by a plunger body to a second end having a blunt smooth tip, said gripping member comprising a swivel joint axially aligned with said plunger.

Claim 7

An injection device according to claim 2 , wherein said second end of said guide wire comprises a gripping member.

Claim 8

An injection device according to claim 2 , wherein said aligning cannulae comprises a textured surface on said gripping end.

Claim 9

An injection device according to claim 2 , wherein said delivery cannulae comprises a securing edge on said distal end.

Claim 10

An injection device according to claim 2 , wherein said plunger comprises a plunger gripping member connected by a plunger body to a blunt smooth tip end.

Claim 11

An injection device according to claim 2 , wherein said guide wire comprises an attached longitudinally aligned Luer lock connector.

Claim 12

An injection device according to claim 10 , wherein said handle comprises a Luer lock configured to releasably engage said Luer lock connector of said guide wire, said handle further comprising a longitudinally aligned lumen opening at each end of said handle.

Claim 13

An injection device according to claim 2 , wherein said device is formed of materials selected from the group consisting of stainless steel, anodized aluminum, thermoplastics and glass.

Claim 14

An injection device according to claim 2 , wherein said delivery cannulae lumen comprises multiple lumens.

Claim 15

An injection device according to claim 1 , further comprising: an elongated guide wire, said guide wire having a first end and a second end connected by an elongated guide wire body, and said first end being configured with a taper, said taper being capable of breaching cortical bone sufficient to form a channel through said cortical bone, wherein said delivery cannulae is sized and configured to slidably pass circumferentially over said guide wire.

Claim 16

A kit for introducing an injectable material into a subject, the kit comprising: an injection device according to claim 1 ; and an injectable material selected from the group consisting of bone cement, antibiotics, whole cellular implants, natural products of cells, recombinant nucleic products and protein products of recombinant cells.

Claim 17

A kit according to claim 15 , wherein said injectable material is polymethylmethacrylate.

Claim 18

An injection device in combination with an injectable material comprising: an elongated guide wire, said guide wire having a first end and a second end connected by an elongated guide wire body, and said first end being configured with a taper, said taper being capable of breaching cortical bond sufficient to form a channel through said cortical bone; an aligning cannulae having a gripping end and a tapered end, said aligning cannulae being sized and configured to slidably pass circumferentially over said guide wire; a delivery cannulae having a proximal end and a distal end, which are connected by a cannulae body; and a lumen capable of acting as a material conduit, said lumen passing from said proximal end through said distal end, said delivery cannulae being sized and configured to slidably pass circumferentially over said aligning cannulae; an elongated plunger, said plunger being sized and configured to slidably pass through said lumen so as to force said injectable material through said lumen while permitting air from said lumen to escape proximally past said plunger; a removable handle configured for secure attachment to said proximal end of said delivery cannulae, said delivery cannulae being equipped with a handle retention member integrally formed in said proximal end of said delivery cannulae; and an injectable material provided to said lumen of said delivery cannulae, said injectable material being of a consistency such that upon controlled movement of said plunger, said injectable material will flow through said lumen.

Claim 19

An injection device in combination with an injectable material comprising: an elongated guide wire, said guide wire having a first end and a second end connected by an elongated guide wire body, and said first end being configured with a taper, said taper being capable of breaching cortical bond sufficient to form a channel through said cortical bone; an aligning cannulae having a gripping end and a tapered end, said aligning cannulae being sized and configured to slidably pass circumferentially over said guide wire; a delivery cannulae having a proximal end and a distal end, which are connected by a cannulae body; and a lumen capable of acting as a material conduit, said lumen passing from said proximal end through said distal end, said delivery cannulae being sized and configured to slidably pass circumferentially over said aligning cannulae; an elongated plunger, said plunger being sized and configured to slidably pass through said lumen so as to force said injectable material through said lumen while permitting air from said lumen to escape proximally past said plunger; a removable handle configured for secure attachment to said proximal end of said delivery cannulae, said delivery cannulae being equipped with a handle retention member integrally formed in said proximal end of said delivery cannulae; and an injectable material provided to said lumen of said delivery cannulae, said injectable material being of a consistency such that upon controlled movement of said plunger, said injectable material will flow through said lumen.

Claim 20

An injection device according to claim 17 , wherein said injectable material is selected from the group consisting of bone cement, antibiotics, cellular implants, natural products of cells recombinant nucleic acid products, and protein products of recombinant cells.

Claim 21

An intraosseous device comprising: an elongated guide wire, said guide wire having a first end and a second end connected by an elongated guide wire body, and said first end being configured with a taper, said taper being capable of breaching cortical bone sufficient to form a channel through said cortical bone; an aligning cannulae having a gripping end and a tapered end, said aligning cannulae being sized and configured to slidably pass circumferentially over said guide wire; a delivery cannulae having a proximal end and a distal end, which are connected by a cannulae body, and a lumen capable of acting as a material conduit, said lumen passing from said proximal end through said distal end, said delivery cannulae being sized and configured to slidably pass circumferentially over said aligning cannulae; an elongated plunger, said plunger being sized and configured to slidably pass through said lumen so as to force said injectable material through said lumen while permitting air from said lumen to escape proximally past said plunger; a removable handle configured for secure attachment to said proximal end of said delivery cannulae, said delivery cannulae being equipped with a handle retention member integrally formed in said proximal end of said delivery cannulae.

Claim 22

An intraosseous device comprising: an elongated guide wire, said guide wire having a first end and a second end connected by an elongated guide wire body, and said first end being configured with a taper, said taper being capable of breaching cortical bone sufficient to form a channel through said cortical bone; an aligning cannulae having a gripping end and a tapered end, said aligning cannulae being sized and configured to slidably pass circumferentially over said guide wire; a delivery cannulae having a proximal end and a distal end, which are connected by a cannulae body, and a lumen capable of acting as a material conduit, said lumen passing from said proximal end through said distal end, said delivery cannulae being sized and configured to slidably pass circumferentially over said aligning cannulae; an elongated plunger, said plunger being sized and configured to slidably pass through said lumen so as to force said injectable material through said lumen while permitting air from said lumen to escape proximally past said plunger; a removable handle configured for secure attachment to said proximal end of said delivery cannulae, said delivery cannulae being equipped with a handle retention member integrally formed in said proximal end of said delivery cannulae.

Claim 25

A method according to claim 20 , wherein said guide wire introducing step is into the body of a vertebra of the subject via an approach selected from the group consisting of postero-lateral approach, unilateral approach, bilateral approach and lateral intracortical bone penetration approach.

Claim 26

A method according to claim 20 , wherein said guide wire introducing step is into the body of a vertebra of the subject via a transpedicular approach.

Claim 27

An injection device for the injection of an injectable material comprising: a delivery cannulae having a proximal end and a distal end, which are connected by a cannulae body, and a lumen capable of acting as a material conduit, said lumen passing from said proximal end through said distal end; a syringe system releasably connected to said delivery cannulae and in fluid communication with said delivery cannulae lumen, said syringe system comprising a lumen and a syringe plunger tip, said syringe plunger tip having at least one air passage and being sized to slidably move within said lumen of said syringe system so as to allow the proximal flow of air past said plunger tip while said plunger tip moves distally with said syringe system to force said injectable material into said delivery cannulae; a removable handle configured for secure attachment to said proximal end of said delivery cannulae, said delivery cannulae being equipped with a handle retention member integrally formed in said proximal end of said delivery cannulae.

Claim 28

An injection device for the injection of an injectable material comprising: a delivery cannulae having a proximal end and a distal end, which are connected by a cannulae body, and a lumen capable of acting as a material conduit, said lumen passing from said proximal end through said distal end; a syringe system releasably connected to said delivery cannulae and in fluid communication with said delivery cannulae lumen, said syringe system comprising a lumen and a syringe plunger tip, said syringe plunger tip having at least one air passage and being sized to slidably move within said lumen of said syringe system so as to allow the proximal flow of air past said plunger tip while said plunger tip moves distally with said syringe system to force said injectable material into said delivery cannulae; a removable handle configured for secure attachment to said proximal end of said delivery cannulae, said delivery cannulae being equipped with a handle retention member integrally formed in said proximal end of said delivery cannulae.

Claim 29

An injection device according to claim 23 , wherein said syringe system is removably connected to said delivery cannulae by a connector selected from the group consisting of a Luer lock, a bayonet fitting, and a hydraulic quick disconnect fitting.

Claim 30

An injection device according to claim 24 , wherein said connector is integral with said proximal end of said delivery cannulae and is aligned with the longitudinal axis of said delivery cannulae body.

Claim 31

An injection device according to claim 24 , wherein said connector of said delivery cannulae is a Luer lock and said handle comprises a Luer lock configured to releasably engage said Luer lock connector of said delivery cannulae, said handle further comprising a longitudinally aligned handle lumen opening at each end of said handle, said handle lumen being in fluid communication with said lumen of said delivery cannulae.

Claim 32

An injection device according to claim 26 , wherein said handle further comprises a view slot sized and configured to permit viewing of the handle lumen.

Claim 33

An injection device according to claim 26 , wherein said handle further comprises a first clearance hole passing through said handle perpendicular to said handle lumen, said first clearance hole being sized and configured to slidably receive said guide wire.

Claim 34

An injection device according to claim 28 , wherein said handle further comprises a second clearance hole passing through said handle perpendicular to said handle lumen, said second clearance hole being sized and configured to slidably receive said aligning cannulae.

Claim 35

An injection device according to claim 26 , wherein said handle further comprises a removable proximal Luer lock end.

Claim 36

An injection device according to claim 23 , wherein said syringe system is connected to said delivery cannulae by a flexible conduit.

Claim 37

An injection device according to claim 23 , wherein said syringe system comprises an automated impelling unit.

Claim 38

An injection device according to claim 32 , wherein said automated impelling unit being capable of controlling the rate and amount of movement of said syringe plunger tip.

Claim 39

An injection device according to claim 33 , wherein said automated impelling unit further comprises a pressure sensing unit.

Claim 40

A kit for introducing an injectable material into a subject, the kit comprising: an injection device according to claim 24 and an injectable material selected from the group consisting of bone cement, antibiotics, whole cellular implants, natural products of cells, recombinant nucleic products and protein products of recombinant cells.

Claim 41

A kit according to claim 35 , wherein said injectable material is polymethylmethacrylate.