CERVICAL SPINOUS PROCESS STAPLE

Abstract

Thoracic/lumbar and cervical spinous process staples which staple/fuse adjacent spinous processes are disclosed. Thoracic/lumbar transverse process staples which staple/fuse adjacent transverse processes are also disclosed. Each embodiment has upper and lower claws connected by a ratchet spring mechanism, along with a multiplicity of bone fastener prongs attached to the upper and lower claws. Two sets of prongs on each staple claw are spaced by a distance approximately equal to the distance separating adjacent spinous or transverse processes so as to facilitate stapling/fusion of two adjacent processes. Also disclosed are staple prongs with multiple perforations which enable incorporation of bone fusion material thereby facilitating stapling/fusion of spinal elements.

Claims

1. (canceled)

2. A spinous process fixation device comprising: a first elongate clamping structure extending from a first end to a second end and having a first spinous process engagement surface between the first end and the second end with a first set of bone fastener prongs extending from the first spinous process engagement surface proximate the first end and a second set of bone fastener prongs extending from the first spinous process engagement surface proximate the second end, wherein the first set of bone fastener prongs is separated from the second set of bone fastener prongs by a first portion of the first spinous process engagement surface that does not include bone fastener prongs; a second elongate clamping structure extending from a third end to a fourth end and having a second spinous process engagement surface between the third end and the fourth end with a third set of bone fastener prongs extending from the second spinous process engagement surface proximate the third end and a fourth set of bone fastener prongs extending from the second spinous process engagement surface proximate the fourth end, wherein the third set of bone fastener prongs is separated from the fourth set of bone fastener prongs by a second portion of the second spinous process engagement surface that does not include bone fastener prongs; and a ratcheting mechanism connecting the first elongate clamping structure to the second elongate clamping structure, wherein the ratcheting mechanism comprises a rod extending at least partially through a first hole defined in the first elongate clamping structure and a second hole defined in the second elongate clamping structure, wherein the spinous process fixation device is configured to ratchet and fix a first spinous process with respect to a second spinous process with the first spinous process positioned between the first and second spinous process engagement surfaces so as to be engaged by the first and third sets of bone fastener prongs and with the second spinous process positioned between the first and second spinous process engagement surfaces so as to be engaged by the second and fourth sets of bone fastener prongs.

3. The spinous process fixation device of claim 2, and further comprising at least one spacer configured to occupy and maintain inter-spinous space in between the first and second spinous processes.

4. The spinous process fixation device of claim 3, wherein the spacer is configured to attach to at least one of the first and second elongate clamping structures at a location without prongs.

5. The spinous process fixation device of claim 3, and further comprising means for connecting the spacer to the first elongate clamping structure.

6. The spinous process fixation device of claim 3, wherein the spacer has a proximal portion and two protrusions extending distally away from the proximal portion and wherein the spacer defines a hole in the proximal portion for connecting the spacer to at least one of the first and second elongate clamping structures.

7. The spinous process fixation device of claim 6, wherein the two protrusions of the spacer have a tapered shape.

8. The spinous process fixation device of claim 2, and further comprising means for occupying and maintaining inter-spinous space in between the first and second spinous processes, thereby alleviating spinal canal compression and any ensuing lumbar stenosis.

9. The spinous process fixation device of claim 2, wherein the ratcheting mechanism automatically locks the first and second elongate clamping structures in position on the first and second spinous processes when the first and second elongate clamping structures are compressed against the first and spinous processes.

10. The spinous process fixation device of claim 2, wherein the ratcheting mechanism further comprises a ratchet pawl.

11. The spinous process fixation device of claim 2, wherein the ratcheting mechanism further comprises ratchet teeth.

12. The spinous process fixation device of claim 2, wherein the ratcheting mechanism is connected to the first and second elongate clamping structures proximate the first end and the third end.

13. The spinous process fixation device of claim 2, wherein the prongs includes perforations.

14. The spinous process fixation device of claim 2, wherein the first hole is positioned proximate the first end and the second hole is positioned proximate the third end.

15. The spinous process fixation device of claim 2, wherein the first hole is spaced from both the first and second ends of the first elongate clamping structure near a first midline of the first elongate clamping structure and the second hole is spaced from both the third and fourth ends of the second elongate clamping structure near a second midline of the second elongate clamping structure.

16. The spinous process fixation device of claim 2, wherein the ratcheting mechanism connects the first elongate clamping structure to the second elongate clamping structure at middle portions of the first and second elongate clamping structure.

17. The spinous process fixation device of claim 2, wherein the ratcheting mechanism hingedly connects the first elongate clamping structure to the second elongate clamping structure at middle portions of the first and second elongate clamping structure.

18. The spinous process fixation device of claim 2, and further comprising means to allow packing of bone and/or bone growth material within the bone fastener prongs thereby facilitating the integration/fusion of the spinous process fixation device to the spine, minimizing and/or preventing extrusion, and promoting bone fusion.

19. The spinous process fixation device of claim 2, wherein the first elongate clamping structure can at least partially rotate with respect to the second elongate clamping structure about the rod.

20. The spinous process fixation device of claim 2, wherein the ratchet mechanism prevents an opening movement of the first elongate clamping structure with respect to the second elongate clamping structure in the opening direction at a plurality of positions.

21. The spinous process fixation device of claim 2, wherein the first set of bone fastener prongs is separated from the second set of bone fastener prongs by a first distance that is equal to a spinous process distance such that the first and second elongate clamping structures will engage and perforate adjacent spinous processes.

22. The spinous process fixation device of claim 2, wherein the ratcheting mechanism comprises several ratcheted positions between a fully open position and a fully closed position.

23. The spinous process fixation device of claim 2, wherein the first spinous process engagement surface curves between the first and second ends and the second spinous process engagement surface curves between the third and fourth ends, wherein the first elongate clamping structure further comprises a first exterior surface that is positioned opposite of the first spinous process engagement surface and that curves between the first and second ends and the second elongate clamping structure comprises a second exterior surface that is positioned opposite of the second spinous process engagement surface and that curves between the first and second ends.

24. A method of using the spinous process fixation device of claim 2, the method comprising: positioning the spinous process fixation device on a pair of adjacent spinous processes; and securing the spinous process fixation device to the pair of adjacent spinous processes by clamping the first spinous process engagement surface and the second spinous process engagement surface to the pair of adjacent spinous processes.

25. A method of using the spinous process fixation device of claim 3, the method comprising: connecting the at least one spacer to at least one of the first and second elongate clamping structures; positioning the first elongate clamping structure on a first side of the spinous processes and the second elongate clamping structure on a second side of the spinous processes; positioning the spacer between the spinous processes; and ratcheting the first elongate clamping structure and the second elongate clamping structure together to penetrate the spinous processes with the first, second, third, and fourth sets of bone fastener prongs and secure the spinous processes between the first and second elongate clamping structures.

26. A spinous process fixation device comprising: a first elongate clamping structure extending from a first end to a second end and having a first spinous process engagement surface between the first end and the second end with a first set of bone fastener prongs extending from the first spinous process engagement surface proximate the first end and a second set of bone fastener prongs extending from the first spinous process engagement surface proximate the second end, wherein the first set of bone fastener prongs is separated from the second set of bone fastener prongs by a first portion of the first spinous process engagement surface that does not include bone fastener prongs; a second elongate clamping structure extending from a third end to a fourth end and having a second spinous process engagement surface between the third end and the fourth end with a third set of bone fastener prongs extending from the second spinous process engagement surface proximate the third end and a fourth set of bone fastener prongs extending from the second spinous process engagement surface proximate the fourth end, wherein the third set of bone fastener prongs is separated from the fourth set of bone fastener prongs by a second portion of the second spinous process engagement surface that does not include bone fastener prongs; at least one spacer configured to occupy and maintain inter-spinous space in between first and second spinous processes, wherein the spacer is configured to attach to at least one of the first and second elongate clamping structures at a location without prongs, wherein the spacer has a proximal portion and two protrusions extending distally away from the proximal portion and wherein the spacer defines a hole in the proximal portion of the spacer for connecting the spacer to at least one of the first and second elongate clamping structures; and a ratcheting mechanism connecting the first elongate clamping structure to the second elongate clamping structure, wherein the ratcheting mechanism comprises a rod extending at least partially through a first hole defined in the first elongate clamping structure and a second hole defined in the second elongate clamping structure such that the first elongate clamping structure can at least partially rotate with respect to the second elongate clamping structure, wherein the spinous process fixation device is configured to ratchet and fix the first spinous process with respect to the second spinous process with the first spinous process positioned between the first and second spinous process engagement surfaces so as to be engaged by the first and third sets of bone fastener prongs and with the second spinous process positioned between the first and second spinous process engagement surfaces so as to be engaged by the second and fourth sets of bone fastener prongs.

27. A spinous process fixation device comprising: a first elongate clamping structure extending from a first end to a second end and having a first spinous process engagement surface between the first end and the second end with a first set of bone fastener prongs extending from the first spinous process engagement surface proximate the first end and a second set of bone fastener prongs extending from the first spinous process engagement surface proximate the second end, wherein the first set of bone fastener prongs is separated from the second set of bone fastener prongs by a first portion of the first spinous process engagement surface that does not include bone fastener prongs; a second elongate clamping structure extending from a third end to a fourth end and having a second spinous process engagement surface between the third end and the fourth end with a third set of bone fastener prongs extending from the second spinous process engagement surface proximate the third end and a fourth set of bone fastener prongs extending from the second spinous process engagement surface proximate the fourth end, wherein the third set of bone fastener prongs is separated from the fourth set of bone fastener prongs by a second portion of the second spinous process engagement surface that does not include bone fastener prongs; and a ratcheting mechanism connecting the first elongate clamping structure to the second elongate clamping structure, wherein the ratcheting mechanism comprises a rod extending at least partially through a first hole defined in the first elongate clamping structure and a second hole defined in the second elongate clamping structure, wherein the ratcheting mechanism further comprises a pawl pivotably mounted via a pivot pin and engageable with a plurality of teeth of the ratchet mechanism to allow for rotation to ratchet in a first direction and to inhibit rotation in an opposite direction, wherein tightening of the ratchet mechanism is configured to move the first elongate clamping surface toward the second elongate clamping surface to fix a first spinous process with respect to a second spinous process with the first spinous process positioned between the first and second spinous process engagement surfaces so as to be engaged by the first and third sets of bone fastener prongs and with the second spinous process positioned between the first and second spinous process engagement surfaces so as to be engaged by the second and fourth sets of bone fastener prongs.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0065] The accompanying drawings are presented to aid in the description of embodiments of the invention and are provided solely for illustration of the embodiments and not limitation thereof.

[0066] FIG. 1A illustrates a perspective (lateral) view of the thoracic/lumbosacral Spinous Process (SP) staple in a closed position, according to an exemplary embodiment of the invention.

[0067] FIG. 1B illustrates a side perspective (top oblique) view of the thoracic/lumbosacral SP staple in an open position, according to an exemplary embodiment of the invention.

[0068] FIG. 1C illustrates a perspective (lateral) view of the thoracic/lumbosacral SP staple in an open position, according to an exemplary embodiment of the invention.

[0069] FIG. 1D illustrates an exploded view of the thoracic/lumbosacral SP staple, according to an exemplary embodiment of the invention.

[0070] FIG. 2A illustrates a perspective (top oblique) assembly view of the lumbosacral Spinous Process (SP) staple articulating with two SPs in a partially open (partially clamped) position, according to an exemplary embodiment of the invention.

[0071] FIG. 2B illustrates a perspective (top oblique) assembly view of the lumbosacral SP staple articulating with two SPs in a partially open (partially clamped) position, according to an exemplary embodiment of the invention.

[0072] FIG. 2C illustrates a perspective (top oblique) assembly view of the lumbosacral SP staple articulating with two SPs in a closed (damped) position, according to an exemplary embodiment of the invention.

[0073] FIG. 2D illustrates a top assembly view of the lumbosacral SP staple articulating with two SPs in a closed (clamped) position, according to an exemplary embodiment of the invention.

[0074] FIG. 2E illustrates a top (posterior-oblique) assembly perspective view of the lumbosacral SP staple articulating with two SPs in a closed (clamped) position, according to an exemplary embodiment of the invention.

[0075] FIG. 3A illustrates a perspective (lateral) view of the thoracic/lumbosacral Transverse Process (TP) staple in a partially closed (partially clamped) position, according to an exemplary embodiment of the invention.

[0076] FIG. 3B illustrates a perspective (top oblique) view of the thoracic/lumbosacral TP staple in an open (undamped) position, according to an exemplary embodiment of the invention.

[0077] FIG. 3C illustrates a perspective (lateral oblique) view of the thoracic/lumbosacral TP staple in an open (unclamped) position, according to an exemplary embodiment of the invention.

[0078] FIG. 3D illustrates an exploded view of the thoracic/lumbosacral TP staple, according to an exemplary embodiment of the invention.

[0079] FIG. 4A illustrates a perspective (side oblique) assembly view of the lumbosacral Transverse Process (TP) staple articulating with two TPs in a partially open (partially clamped) position, according to an exemplary embodiment of the invention.

[0080] FIG. 4B illustrates a perspective (side oblique) assembly view of the lumbosacral TP staple articulating with two TPs in a partially open (partially clamped) position, according to an exemplary embodiment of the invention.

[0081] FIG. 4C illustrates a perspective (side oblique) assembly view of the lumbosacral TP staple articulating with two TPs in a closed (clamped) position, according to an exemplary embodiment of the invention.

[0082] FIG. 4D illustrates a side perspective (posterior oblique) assembly view of the lumbosacral TP staple articulating with two TPs in a closed (clamped) position, according to an exemplary embodiment of the invention.

[0083] FIG. 5 illustrates a side perspective (posterior-oblique) assembly view of the thoracic/lumbosacral Spinous Process (SP) and Transverse Process (TP) staples engaging (clamped position) SPs and TPs of two adjacent spinal units, according to an exemplary embodiment of the invention.

[0084] FIG. 6A illustrates a side perspective (top oblique) view of the cervical Spinous Process (SP) staple in a partially open (partially clamped) position, according to an exemplary embodiment of the invention.

[0085] FIG. 6B illustrates a side perspective view of the cervical SP staple in a partially open (partially clamped) position, according to an exemplary embodiment of the invention.

[0086] FIG. 6C illustrates an exploded view of the cervical SP staple, according to an exemplary embodiment of the invention.

[0087] FIG. 7A illustrates a top perspective (side-oblique) assembly view of the cervical SP staple articulating with two SPs in a wide open position, according to an exemplary embodiment of the invention.

[0088] FIG. 7B illustrates a top perspective (top oblique) assembly view of the cervical SP staple articulating with two SPs in a closed (clamped) position, according to an exemplary embodiment of the invention.

[0089] FIG. 7C illustrates a side assembly view of the cervical SP staple articulating with two SPs in a closed (clamped) position, according to an exemplary embodiment of the invention.

[0090] FIG. 7D illustrates a bottom assembly view of the cervical SP staple articulating with two SPs in a closed (clamped) position, according to an exemplary embodiment of the invention.

[0091] FIG. 8A illustrates a perspective view of the straight-solid staple prong, according to an exemplary embodiment of the invention.

[0092] FIG. 8B illustrates a perspective view of the straight-perforated staple prong, according to an exemplary embodiment of the invention.

[0093] FIG. 8C illustrates a perspective view of the curved-solid staple prong, according to an exemplary embodiment of the invention.

[0094] FIG. 8D illustrates a perspective view of the curved-perforated staple prong, according to an exemplary embodiment of the invention.

[0095] FIG. 9A illustrates a bottom perspective view of the straight-perforated staple prong, according to an exemplary embodiment of the invention.

[0096] FIG. 9B illustrates a bottom perspective view of the curved-perforated staple prong, according to an exemplary embodiment of the invention.

[0097] FIG. 10A illustrates a perspective (top oblique) view of the SP staple in an open position, according to an exemplary embodiment of the invention.

[0098] FIG. 10B illustrates a perspective (lateral) view of the SP staple in an open position, according to an exemplary embodiment of the invention.

[0099] FIG. 11A illustrates a perspective assembly (top oblique) view of the SP staple articulating with two SPs in an open position (wide open), according to an exemplary embodiment of the invention.

[0100] FIG. 11B illustrates a perspective assembly (top oblique) view of the SP staple articulating with two SPs in a partially open position (partially clamped), according to an exemplary embodiment of the invention.

[0101] FIG. 11C illustrates a perspective assembly (top oblique) view of the SP staple articulating with two SPs in a closed position, according to an exemplary embodiment of the invention.

[0102] FIG. 12A illustrates a perspective view of two opposing hemi-spacers, according to an exemplary embodiment of the invention.

[0103] FIG. 12B illustrates a perspective view of sequential interdigitation of opposing hemi-spacers forming a united single interspinous spacer wedge, according to an exemplary embodiment of the invention.

[0104] FIGS. 13A-B illustrate a Lumbar facet joint staple with a calibrated ratcheting mechanism in opened (FIG. 13A) and closed (FIG. 13B) positions.

[0105] FIGS. 14A-B illustrate an embodiment of a posterior lumbar facet staple, flexure spring embodiment in side isometric (FIG. 14A) and exploded (FIG. 14B) views.

[0106] FIGS. 15A-C illustrate an embodiment of a posterior lumbar facet staple, torsional spring embodiment in side isometric (FIG. 15A), bottom isometric (FIG. 15B), and exploded (FIG. 15C) views.

[0107] FIGS. 16A-C illustrate an embodiment of a Lumbar facet joint staple gun in side (FIG. 16A), exploded (FIG. 16B) and cross-sectional (FIG. 16C) views.

[0108] FIGS. 17A-D illustrate an embodiment of a Lumbar facet joint, staple gun in side view (FIG. 17A), exploded (FIG. 17B) and cross-sectional (FIG. 17C) and front-on (FIG. 17D) view.

[0109] FIGS. 18A-B illustrate an embodiment of a posterior lumbar facet staple, flexure spring embodiment in side isometric (FIG. 18A) and exploded (FIG. 18B) views.

[0110] FIGS. 19A-C illustrate an embodiment of a posterior lumbar facet staple, torsional spring embodiment in side isometric (FIG. 19A), bottom isometric (FIG. 19B), and exploded (FIG. 19C) views.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

[0111] The present invention now is described more fully hereinafter with reference to the accompanying drawings, in which embodiments of the invention are shown. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. Alternate embodiments may be devised without departing from the scope of the invention. Additionally, well known elements of the invention will not be described in detail or will be omitted so as not to obscure the relevant details of the invention. The word “exemplary” is used herein to mean “serving as an example, instance, or illustration.” Any embodiment described herein as “exemplary” is not necessarily to be construed as preferred or advantageous over other embodiments. Likewise the term “embodiments of the invention” does not require that all embodiments of the invention include the discussed feature, advantage or mode of operation.

[0112] With reference to FIGS. 1A-19C, exemplary embodiments of the invention will now be described.

[0113] 1. Exemplary Medical Device

[0114] Referring to FIGS. 1-9, the above described problems of the conventional art can be solved in the thoracic, lumbar and cervical spines by insertions.

[0115] For example, FIGS. 1A-1D illustrate three dimensional views of an embodiment of the thoracic/lumbosacral Spinous Process (SP) staple apparatus 100a.

[0116] FIGS. 1A-1D illustrate an exemplary embodiment of a thoracic/lumbosacral SP staple 100a, for example, including a flexure spring (e.g., ratchet pawl 128). As shown in FIGS. 1A-1D, the features of the staple 100a can include top claws 110 and bottom claws 112 with claw ridges 114 to help incorporate and fuse with bone. A staple pin-pivot 118 can connect the top claws 110 and bottom claws 112. The staple 100a may include fastener pins/prongs 122 to help incorporate and fuse with bone; however, the staple 100a is not limited to any number of fastener pins/prongs 122. For example in the illustrated embodiments, the staple 100a includes sixteen fastener pins/prongs 122; eight per the top claw 110 and eight per the bottom claw 112. Further, a total of eight prongs 122 for engagement of two segmental SPs may be utilized such that each SP may be penetrated and perforated by a total of eight prongs 122; four prongs per single SP unit of penetration/engagement on the top claw 110 and four prongs per single SP unit of penetration/engagement on the bottom claw. However, in other embodiments, the staple 100a can include other amounts of fastener pins/prongs 122, such as four, six, eight, ten, etc. for engagement of the segmental SPs.

[0117] Claw teeth 116 may be molded onto the top claw 110 and bottom claw 112, and the claw teeth 116 may be interdigitating. Further, ratchet teeth 124 may be molded onto the bottom claw 112 (shown in FIGS. 1A-1B), and a ratchet pawl 128 (e.g., spring loaded ratchet pawl) may interact with the ratchet teeth 124 locking the staple 100a in position. The ratchet pawl 128 can be connected to the top claw 110 via ratchet bolt 120 and can rotate about the ratchet bolt 120 (shown in FIGS. 1A-1B).

[0118] In another embodiment, ratchet teeth 124 may also be molded on the top claw 110 (shown in FIGS. 1C-1D), and the ratchet pawl 128 may interact with the ratchet teeth 124 locking the staple 100a in position. The ratchet pawl 128 can be connected to the bottom claw 112 via ratchet bolt 120 and can rotate about the ratchet bolt 120 (shown in FIGS. 1C-1D).

[0119] As the staple 100a closes, the ratchet pawl 128 works in standard fashion. When a force is applied to open the staple 100a, the ratchet pawl 128 (e.g., a flexure spring) interacts with the ratchet teeth 124 exhibiting spring-like qualities due to its curvature resulting in the ratchet mechanism “locking up.” Thus, the material used fix the ratchet pawl 128 can contribute to the deformability and springiness of the ratchet mechanism, resulting in varying degrees of deformability and spring-like resistance. The ratchet mechanism can limit the opening force of the staple 100a by a force proportional to the stiffness of the ratchet pawl 128 (e.g., flexure spring). Further, the force can be tailored by making the ratchet pawl 128 from different materials or varying the dimension(s) of the ratchet pawl 128, or flexure spring portion of the ratchet pawl 128. This embodiment can achieve significant rigidity (stiffness).

[0120] FIGS. 2A-2E illustrate a step-by-step mechanical engagement of an exemplary embodiment of a thoracic/lumbosacral Spinous Process (SP) staple 100a with two segmental SPs; beginning with the staple's fully opened position (FIG. 2A), then subsequently progressing to a semi-closed (partially clamped) position (FIG. 2B), and then subsequently and finally achieving a fully clamped position (FIGS. 2C-2E) entirely engaging and unifying the two segmental SPs.

[0121] FIGS. 3A-3D illustrate an exemplary embodiment of a thoracic/lumbosacral Transverse Process (TP) staple 100b.

[0122] As shown in FIGS. 3A-3D, the features of the staple 100b can include a top claw 110 and a bottom claw 112, each having claw ridges 114 to help incorporate and fuse with bone. A staple pin-pivot 118 can connect the top claw 110 and the bottom claw 112. The staple 100b may include fastener pins/prongs 122 to help incorporate and fuse with bone; however, the staple 100b is not limited to any number of fastener pins/prongs 122. For example in the illustrated embodiments, the staple 100b includes eight fastener pins/prongs 122; four per the top claw 110 and four per the bottom claw 112. Further, a total of four prongs 122 for engagement of two segmental TPs may be utilized such that each TP may be penetrated and perforated by a total of four prongs; two prongs per single TP unit of penetration/engagement on the top claw 110 and two prongs per single TP unit of penetration/engagement on the bottom claw 112. However, in other embodiments, the staple 100b can include other amounts of fastener pins/prongs 122, such as two, four, six, eight, ten, etc. for engagement, of the segmental TPs.

[0123] Claw teeth 116 may be molded onto the top claw 110 and bottom claw 112, and the claw teeth 116 may be interdigitating. Further, ratchet teeth 124 may be molded on the top claw 110 (shown in FIGS. 3A-D), and the ratchet pawl 128 may interact with the ratchet teeth 124 locking the staple 100b in position. The ratchet pawl 128 can be connected to the bottom claw 112 via ratchet bolt 120 and can rotate about the ratchet bolt 120 (shown in FIGS. 3A-3D).

[0124] In another embodiment, ratchet teeth 124 may also be molded onto the bottom claw 112 (not shown), and a ratchet pawl 128 may interact with the ratchet teeth 124 locking the staple 100b in position. In this embodiment, the ratchet pawl 128 can be connected to the top claw 110 via ratchet bolt 120 and can rotate about the ratchet bolt 120 (not shown).

[0125] As the staple 100b closes, the ratchet pawl 128 works in standard fashion. When a force is applied to open the staple 100b, the ratchet pawl 128 (e.g., a flexure spring) interacts with the ratchet teeth 124 exhibiting spring-like qualities due to its curvature resulting in the ratchet mechanism “locking up.” Thus, the material used for the ratchet pawl 128 can contribute to the deformability and springiness of the ratchet mechanism, resulting in varying degrees of deformability and spring-like resistance. The ratchet mechanism can limit the opening force of the staple 100b by a force proportional to the stiffness of the ratchet pawl 128 (e.g., flexure spring). Further, the force can be tailored by making the ratchet pawl 128 from different materials or varying the dimension(s) of the ratchet pawl 128, or a flexure spring portion of the ratchet pawl 128. This embodiment can achieve significant rigidity (stiffness).

[0126] FIGS. 4A-4D illustrate a step-by-step mechanical engagement of an exemplary embodiment of a thoracic/lumbosacral Transverse Process (TP) staple 100b with two segmental TPs; beginning with the staple's fully opened position (FIG. 4A), then subsequently progressing to a semi-closed position (partially clamped) (FIG. 4B), and then subsequently and finally achieving a fully clamped position (FIGS. 4C-4D) entirely engaging and unifying the two segmental TPs.

[0127] FIG. 5 illustrates an exemplary embodiment of both a fully clamped thoracic/lumbosacral SP staple 100a and a fully clamped thoracic/lumbosacral TP staple 100b used to concomitantly staple/fuse two segmental spinal units.

[0128] FIGS. 6A-6C illustrate an exemplary embodiment of a cervical Spinous Process (SP) staple 100c.

[0129] As shown in FIGS. 6A-6C, the features of the staple 100c can include a top claw 110 and a bottom claw 112, each having claw ridges 114 to help incorporate and fuse with bone. A staple pin-pivot 118 can connect the top claw 110 and the bottom claw 112. The staple 100c may include fastener pins/prongs 122 to help incorporate and fuse with bone; however, the staple 100c is not limited to any number of fastener pins/prongs 122. For example in the illustrated embodiments, the staple 100c includes four fastener pins/prongs 122; two per the top claw 110 and two per the bottom claw 112. Further, a total of two prongs 122 for engagement of each SP may be utilized such that each SP may be penetrated and perforated by a total of two prongs 122; one prong per single SP unit of penetration/engagement on the top claw 110 and one prong per single SP unit of penetration/engagement on the bottom claw 112. However, in other embodiments, the staple 100c can include other amounts of fastener pins/prongs 122, such as six, eight, ten, etc. for engagement of the cervical SPs.

[0130] Claw teeth 116 may be molded onto the top claw 110 and the bottom claw 112, and the claw teeth 116 may be interdigitating. Further, ratchet teeth 124 may be molded onto the bottom claw 112 (shown in FIGS. 6A-6C), and a ratchet pawl 128 may interact with the ratchet teeth 124 locking the staple 100c in position. The ratchet pawl 128 can be connected to the top claw 110 via ratchet bolt 120 and can rotate about the ratchet bolt 120 (shown in FIGS. 6A-6C).

[0131] In another embodiment, ratchet teeth 124 may also be molded on the top claw 110 (not shown), and the ratchet pawl 128 may interact with the ratchet teeth 124 locking the staple 100c in position. The ratchet pawl 128 can be connected to the bottom claw 112 via ratchet bolt 120 and can rotate about the ratchet bolt 120 (not shown).

[0132] As the staple 100c closes, the ratchet pawl 128 works in standard fashion. When a force is applied to open the staple 100c, the ratchet pawl 128 (e.g., a flexure spring) interacts with the ratchet teeth 124 exhibiting spring-like qualities due to its curvature resulting in the ratchet mechanism “locking up.” Thus, the material used for the ratchet pawl 128 can contribute to the deformability and springiness of the ratchet mechanism, resulting in varying degrees of deformability and spring-like resistance. The ratchet mechanism can limit the opening force of the staple 100c by a force proportional to the stiffness of the ratchet pawl 128 (e.g., flexure spring). Further, the force can be tailored by making the ratchet pawl 128 from different materials or varying the dimension(s) of the ratchet pawl 128, or a flexure spring portion of the ratchet pawl 128. This embodiment can achieve significant rigidity (stiffness).

[0133] FIGS. 7A-7E illustrate a step-by-step mechanical engagement of an exemplary embodiment of the cervical Spinous Process (SP) staple 100c with two segmental cervical SPs; beginning with the staple's fully opened position (FIG. 7A), and then subsequently progressing to a fully clamped position (FIGS. 7B-7D) entirely engaging and unifying the two cervical TPs.

[0134] FIGS. 8A-8D illustrate exemplary embodiments of a straight fastener solid prong 122a, a straight perforated fastener prong 122b, a curved fastener solid prong 122c, and a curved perforated fastener prong 122d.

[0135] FIGS. 9A-9B illustrate a bottom perspective view of a straight-perforated staple prong 122b and a bottom perspective view of a curved-perforated staple prong 122d. The perforations 800 of these prongs allow insertion of bone and/or fusion material facilitating the fusion of the device to the spinous process thereby facilitating fusion. The perforations 800 can also be applied to other pins, staple screws involved in securing bone to facilitate fusion.

[0136] An exemplary embodiment of a thoracic/lumbar Spinous Process (SP) staple, can include first claw means (e.g., 110 or 112), second claw means (e.g., 110 or 112), a staple pin (e.g., 118) pivotally connecting the first claw means and the second claw means (e.g., 110, 112), and ratchet means (e.g., 124, 128) for limiting an opening force of the first claw means (e.g., 110 or 112) with respect to the second claw means (e.g., 110 or 112).

[0137] 2. Exemplary Surgical Method

[0138] Exemplary surgical steps for practicing one or more of the foregoing exemplary embodiments will now be described.

[0139] Surgical implantation of the thoracic/lumbosacral Spinous Process (SP) staple (e.g., 100a) conjoining two adjacent SPs can be performed under standard open, closed, percutaneous, endoscopic, tubular, microscopic, fluoroscopic or any other standardized techniques. The staple (e.g., 100a) is applied to and engages with a staple gun (for example, as described in related application Ser. No. 12/471,345, filed on May 22, 2009, application Ser. No. 12/471,340, filed on May 22, 2009, Ser. No. 12/054,335 filed on Mar. 24, 2008, Ser. No. 11/842,855, filed on Aug. 21, 2007, Ser. No. 11/536,815 filed on Sep. 29, 2006, and Ser. No. 11/208,644 filed on Aug. 23, 2005, which describe a facet joint (FJ) staple and staple gun). The staple gun can have a straight distal applier or angled applier to facilitate placement depending on the particular spinal anatomy. Upon exposure of two adjacent SP processes, the staple (e.g., 100a) is opened via the staple gun applier, the two adjacent SPs are engaged by the opened staple claws (e.g., 110, 112), and the staple gun then closes the upper and lower claws (e.g., 110, 112) which lead to the stapling/fusion of the two adjacent spinous processes (FIGS. 2A-2E). Depending on patient anatomy or surgical preference, the staple prongs (e.g., 122) can be either straight or curved. The staple prongs (e.g., 122) with perforations can be packed with any kind of bony/fusion material prior to placement on SPs. A variety of staples (e.g., 100a) with varying inter-prong distances to account, for inter and intra-patient inter-spinous distance variations can be manufactured. The staple (e.g., 100a) with the correct approximate inter-spinous prong distance is selected.

[0140] Surgical implantation of the thoracic/lumbosacral Transverse Process (TP) staple (e.g., 100b) conjoining two adjacent TPs can be performed under standard open, closed, percutaneous, endoscopic, tubular, microscopic, fluoroscopic or any other standardized techniques. The Transverse Process (TP) staple (e.g., 100b) is applied to, and engages a staple gun (for example, as described in related application Ser. No. 12/471,345, filed on May 22, 2009, application Ser. No. 12/471,340, filed on May 22, 2009, Ser. No. 12/054,335 filed on Mar. 24, 2008, Ser. No. 11/842,855, filed on Aug. 21, 2007, Ser. No. 11/536,815 filed on Sep. 29, 2006, and Ser. No. 11/208,644 filed on Aug. 23, 2005, which describe a facet joint (FJ) staple and staple gun). The staple gun can have a straight distal applier or angled applier to facilitate placement depending on the particular spinal anatomy. Upon exposure of the TP processes, the staple (e.g., 100b) is opened via the staple gun applier, the TPs are engaged by the opened staple claws (e.g., 110, 112), and the staple gun then closes the upper and lower claws (e.g., 110, 112) which lead to the stapling/fusion of two adjacent transverse processes (FIGS. 4A-4D). Depending on patient anatomy or surgical preference, the staple prongs (e.g., 122) can be either straight or curved. The staple prongs (e.g., 122) with perforations can be packed with any kind of bony/fusion material prior to placement on TPs. A variety of staples (e.g., 100b) with varying inter-prong distances to account for inter and intra patient inter TP distance variations can be manufactured. The staple (e.g., 100b) with the correct approximate inter TP prong distance is selected.

[0141] Surgical implantation of the cervical Spinous Process (SP) staple (e.g., 100c) can be performed under standard open, closed, percutaneous, endoscopic, tubular, microscopic, fluoroscopic or any other standardized techniques. The cervical Spinous Process (SP) staple (e.g., 100c) is applied to and engages a staple gun (for example, as described in related application Ser. No. 12/471,345, filed on May 22, 2009, application Ser. No. 12/471,340, filed on May 22, 2009, Ser. No. 12/054,335 filed on Mar. 24,2008, Ser. No. 11/842,855, filed on Aug. 21, 2007, Ser. No. 11/536,815 filed on Sep. 29, 2006, and Ser. No. 11/208,644 filed on Aug. 23, 2005, which describe a facet joint (FJ) staple and staple gun). The staple gun can have a straight distal applier or angled applier to facilitate placement depending on the particular spinal anatomy. Upon exposure of the cervical SP processes, the staple (e.g., 100c) is opened via the staple gun applier, the two adjacent cervical SPs are engaged from above by the opened staple claws (e.g., 110, 112), and the staple gun then closes the upper and lower claws (e.g., 110, 112) which lead to the stapling/fusion of cervical spinous processes (FIGS. 7A-7D). Depending on patient anatomy or surgical preference, the staple prongs (e.g., 122) can be either straight or curved. The staple prongs (e.g., 122) with perforations can be packed with any kind of bony/fusion material prior to placement on SPs. A variety of staples (e.g., 100c) with varying inter-prong distances to account for inter and intra patient inter-spinous distance variations can be manufactured. The staple (e.g., 100c) with the correct approximate inter-spinous prong distance is selected.

[0142] With reference to FIGS. 10A-12B another exemplary embodiment of the invention will now be described.

[0143] 3. Exemplary Medical Device

[0144] Referring to FIGS. 10A-12B, the above described problems of the conventional art can be solved in the thoracic, lumbar and cervical spine.

[0145] For example, FIGS. 10A-B illustrate three dimensional views of an embodiment of the Spinous Process (SP) staple apparatus 100a.

[0146] FIGS. 10A-B illustrate an embodiment of a Spinous Process (SP) staple with interdigitating-interlocking hemi-spacers, for example, including a flexure spring (e.g., ratchet pawl 128). As shown in FIGS. 10A-B, the features of the staple 100 can include top claws 110 and bottom claws 112 with claw ridges 114 to help incorporate and fuse with bone. A staple pin-pivot 118 can connect the top claws 110 and bottom claws 112. The staple 100 may include fastener pins/prongs 122 to help incorporate and fuse with bone; however, the staple 100 is not limited to any number of fastener pins/prongs 122. For example, in the illustrated embodiments, the staple 100 includes sixteen fastener pins/prongs 122; eight per the top claw 110 and eight per the bottom claw 112. Further, a total of eight prongs for engagement of two segmental SPs may be utilized such that each SP may be penetrated and perforated by a total of eight prongs; four prongs per single SP unit of penetration/engagement, on the top claw 110 and four prongs per single SP unit of penetration/engagement on the bottom claw. However, in other embodiments, the staple 100 can include other amounts of fastener pins/prongs 122, such as four, six, eight, ten, etc. for engagement of the segmental SPs.

[0147] Claw teeth 116 may be molded onto the top claw 110 and bottom claw 112, and the claw teeth 116 may be interdigitating. Further, ratchet teeth 124 may be molded onto the bottom claw 112 (shown in FIG. 10A), and a ratchet pawl 128 (e.g., spring loaded ratchet pawl) may interact with the ratchet teeth 124 locking the staple 100 in position. The ratchet pawl 128 can be connected to the top claw 110 via ratchet bolt 120 and can rotate about the ratchet bolt 120 (shown in FIG. 10A).

[0148] In another embodiment, ratchet teeth 124 may also be molded on the top claw 110 (shown in FIG. 10B), and the ratchet pawl 128 may interact with the ratchet teeth 124 locking the staple 100 in position. The ratchet pawl 128 can be connected to the bottom claw 112 via ratchet bolt 120 and can rotate about the ratchet bolt 120 (shown in FIG. 1B).

[0149] As the staple 100 closes, the ratchet pawl 128 works in standard fashion. When a force is applied to open the staple 100, the ratchet pawl 128 (e.g., a flexure spring) interacts with the ratchet teeth 124 exhibiting spring-like qualities due to its curvature resulting in the ratchet mechanism “locking up.” Thus, the material used for the ratchet pawl 128 can contribute to the deformability and springiness of the ratchet mechanism, resulting in varying degrees of deformability and spring-like resistance. The ratchet mechanism can limit the opening force of the staple 100 by a force proportional to the stiffness of the ratchet pawl 128 (e.g., flexure spring). Further, the force can be tailored by making the ratchet pawl 128 from different materials or varying the dimension(s) of the ratchet pawl 128. This embodiment can achieve significant rigidity (stiffness).

[0150] The interior surfaces and/or exterior surfaces of the top claw 110 and bottom claw 112 can include hemi-spacer(s) 130. As shown in FIGS. 10A-B, the hemi-spacer(s) 130 can be positioned on the interior surfaces of the top claw 110 and bottom claw 112 such that when the staple 100 is closed, the hemi-spacer(s) 130 are positioned on opposing surfaces of each other. Each hemi-spacer 130 can be attached to the top claw 110 and bottom claw 12, for example, with a screw 134 or other suitable fixing device. Further, the shape of the hemi-spacer(s) 130 can vary. For example, in the illustrated embodiments, the staple 100 includes hemi-spacer(s) 130 that are rectangular in shape. However, in other embodiments, the hemi-pacers 130 can include other shapes, such as circular, oval, square, etc. In other embodiments, a thickness of the hemi-spacer 130 on one claw can be greater than a thickness of the hemi-spacer 130 on the other claw. In still other embodiments, the hemi-spacer 130 can be formed on only one of the claws 110, 112.

[0151] Further, each hemi-spacer 130 can include interdigitating prongs 132 which can be used to interdigitate, interlock, and unite with corresponding features on another hemi-spacer 130, thereby forming a single interspinous process spacer wedge. The wedge (hemi-spacer pair 130) can occupy and maintain the inter-spinous space in between adjacent Spinous Processes (SPs), thereby alleviating spinal canal compression and any ensuing lumbar stenosis.

[0152] In another exemplary embodiment, each hemi-spacer 130 positioned on opposing staple claws (110, 112) can include interdigitating prongs 132. The interdigitating prongs 132 may include mirror image interlocking protrusions 312 (FIGS. 13A-B) and protrusion receptacles 310 (FIGS. 13A-B). The interlocking protrusions 312 and protrusion receptacles 310 can interact allowing for co-mating and unification of each hemi-spacer 130. Thus, when the top claw 110 and bottom claw 112 of the SP staple 100 are closed (i.e. unit), the fastener prongs 122 will perforate adjacent SPs and the hemi-spacer(s) 130 (and interlocking protrusions 312 and protrusion receptacles 310) will interdigitate, interlock, and unite forming a single interspinous process spacer wedge which maintains separation distraction between SPs, thereby alleviating spinal canal compression thus alleviating lumbar stenosis.

[0153] The hemi-spacers 130 can be attached to each claw 110, 112 of the staple 100, for example, via a screw 134 or other suitable fixing device. Further, different sized hemi-spacers 130 can be selectively and preferentially attached to each claw 110, 112 to account for inter- and intra-patient anatomical variability depending on the interspinous distance. The staples 100 also can be manufactured with various tolerances, e.g. different claw lengths and inter-spinous inter-prong distances, etc. The exemplary embodiments disclosed herein can be used to perform multiple levels of distraction engaging a series of adjacent pair of SPs with one staple 100 per every incremental unit of two adjacent SP elements.

[0154] FIGS. 11A-C illustrate an exemplary embodiment of a step-by-step mechanical engagement of the SP staple 100 with two segmental SPs; beginning with the staple's opened position (FIG. 11A), then subsequently progressing to a semi-closed position (FIG. 11B), and then subsequently and finally achieving a fully clamped position (FIG. 11C) entirely engaging and unifying the two segmental SPs. The hemi-spacer(s) 130 may include mirror image interlocking protrusions 312 (FIGS. 13A-B) and protrusion receptacles 310 (FIGS. 13A-B). The interlocking protrusions 312 and protrusion receptacles 310 can interact allowing for co-mating and unification of each hemi-spacer 130. Thus, when the top claw 110 and bottom claw 112 of the SP staple 100 are closed (i.e., clamped), the fastener prongs 122 will perforate adjacent SPs and the hemi-spacer(s) 130 (and interlocking protrusions 312 and protrusion receptacles 310) will interdigitate, interlock, and unite forming a single interspinous process spacer wedge which maintains separation distraction between SPs, thereby alleviating spinal canal compression thus alleviating lumbar stenosis.

[0155] FIG. 12A illustrates an exemplary embodiment of the hemi-spacer(s) 130 located on opposing staple claws 110, 112. Each hemi-spacer(s) 130 can include one or more hemi-spacer screw inserts 314. Each hemi-spacer(s) 130 can be attached to the top claw 110 and bottom claw 112, for example via one or more screws 134, which can be secured in the one or more hemi-spacer screw inserts 314 and can penetrate one or more perforations (not illustrated) on each claw 110, 112. In the illustrated exemplary embodiment, each hemi-spacer 130 includes a single hemi-spacer screw insert 314, and each hemi-spacer 130 is attached to the top claw 110 and bottom claw 112, respectively, using a single screw 134, which is secured in the hemi-spacer screw insert 314 and penetrates a single perforation (e.g., screw hole or threaded screw hole) (not illustrated) on each claw 110, 112. In other embodiments, the hemi-spacers 130 can be integrally formed. with the claws 110, 112. In other embodiments, the hemi-spacers 130 can be permanently or removably/replaceably fixed to the claws 110, 112 by other suitable fixing means.

[0156] As shown in FIG. 12A, in an exemplary embodiment, a surface of each hemi-spacer 130 can include two mirror image interdigitating protrusions 312 and two mirror image protrusion receptacles 310 which mate with corresponding features on an opposing hemi-spacer 130 when the hemi-spacers 130 are aligned. However, in other embodiments, the hemi-spacer(s) 130 can include any number of mirror image interdigitating protrusions 312 and corresponding mirror image protrusion receptacles 310 which mate with each other when aligned.

[0157] FIG. 12B illustrates an exemplary embodiment of the hemi-spacer(s) 130 whereby two opposing hemi-spacer(s) 130 can unify into a single inter-spinous wedge spacer. For example, in the illustrated embodiments, the mirror image interdigitating protrusions 312 of each opposing hemi-spacer 130 interdigitates and mates with an opposing mirror imago protrusion receptacle 310 of the corresponding hemi-spacer 130. The interdigitating protrusions 312 and their corresponding protrusion receptacles 310 of each hemi-spacer 130 can mate with each other forming a unified interspinous spacer-wedge.

[0158] The exemplary staples 100 can be provided with a variety of inter-prong distances to account for inter and intra-patient inter-spinous distance variations. The hemi-spacers 130 can be formed with different dimensions, such as a variety of heights, lengths, and widths, to account for variations in dimensions between patients.

[0159] The protrusions 312 and protrusion receptacles 310 of the hemi-spacer 130 can have a variety of corresponding shapes. For example, as illustrated in the exemplary embodiments, the sidewalk of the protrusions 312 and protrusion receptacles 310 can have a tapered shape to facilitate easy alignment and engagement/mating therebetween. In other embodiments, the sidewalls of the protrusions 312 and protrusion receptacles 310 can have other shapes, such as conical shapes, pyramid shapes, triangular shapes, square shapes, rectangular shapes, etc.

[0160] 4. Exemplary Surgical Method

[0161] Exemplary surgical steps for practicing one or more of the foregoing embodiments will now be described.

[0162] Surgical implantation of the Spinous Process (SP) staple with interdigitating—interlocking hemi-spacers conjoining and separating/distracting two adjacent SPs can be performed under standard open, closed, percutaneous, endoscopic, tubular, microscopic, fluoroscopic or any other standardized techniques. The SP staple can be applied to and engaged with a staple gun whose design has been described in, for example, Applicants' related pending application Ser. No. 12/471,345, filed on May 22, 2009, application Ser. No. 12/471,340, filed on May 22, 2009, Ser. No. 12/054,335 filed on Mar. 24, 2008, Ser. No. 11/842,855, filed on Aug. 21, 2007, Ser. No. 11/536,815 filed on Sep. 29,2006, and Ser. No. 11/208,644 filed on Aug. 23, 2005, relating to the FJ staple, herein incorporated by reference. The staple gun can have a straight distal applier or angled applier to facilitate placement depending on the particular spinal anatomy. The patient may be positioned prone and flexed or lateral and flexed. After the administration of local anesthesia with or without Intravenous (IV) sedation or any acceptable form of analgesia/anesthesia, an incision is made over the desired adjacent SPs. The interspinous ligament may be partially or completely opened or separated. Upon exposure of two adjacent SP processes, the staple 100 is opened via the staple gun applier, the two adjacent SPs are engaged by the opened staple claws 110, 112, and the staple gun then closes the upper and lower claws 110, 112 which lead to the stapling of the two adjacent SPs (FIGS. 11A-C). The closure of the staple 100 leads to the unification of the two hemi-spacers 130 into one spacer wedge which separates and distracts the adjacent SPs (FIGS. 11A-C and FIGS. 13A-B). A variety of staples 100 can be manufactured with varying inter-prong distances to account for inter and intra-patient inter-spinous distance variations. The staple 100 with the correct approximate inter-spinous prong distance is selected. The hemi-spacers 130 with the desired height, length, and width are selected and may be attached to the staple claws 110, 112 prior to SP stapling. Staples 100 can also be manufactured with different sized hemi-spacers 130 already secured to the claws 110, 112, thereby not necessitating that the surgeon need to fiddle with placement of the hemi-spacers 130 on the staple 100, for example, by attaching with screws 134 (i.e., the hemi-spacers 130 can be pre-installed on the claws 110, 112 of the staple 100). Alternatively, in other embodiments staples 100 with built-in (not screwed in) hemi-spacers 130 of differing dimensions can be selected for different patients.

[0163] In between the two sets of prongs 122 on the upper and lower claws 110, 112 is an attached rectangular hemi-spacer 130. It is positioned to act as a wedge occupying the inter-spinous space in between adjacent SPs. The hemi-spacers 130 on opposing staple claws 110, 112 are designed with mirror image interlocking protrusions 312, and protrusion receptacles 310 allowing their co-mating and thus unification (FIGS. 13A-B). Thus when the upper and lower claws 110, 112 of the SP staple 100 unite, and their prongs 122 perforate adjacent SPs, the hemi-spacers 130 interdigitate, interlock, and unite forming a single interspinous process spacer wedge which maintains distraction between SPs, thereby alleviating spinal canal compression thus alleviating lumbar stenosis (FIGS. 11A-C).

[0164] The hemi-spacers are attached to each claw of the staple via a screw. Depending on the interspinous distance, different sized hemi-spacers (differing in length, height and/or width) can be preferentially attached to each claw to account for inter- and intra-patient anatomical variability.

[0165] Furthermore the staples themselves can be manufactured with different claw lengths and inter-spinous inter-prong distances. Hemi-spacers can be designed in any variety of geometric shape, and mate with any form of interlocking mechanisms entailing extrusions slots, prongs, pins etc.

[0166] The exemplary embodiment of this device can be used to perform multiple levels of distraction engaging a series of adjacent pair of SPs with one staple per every incremental unit of two adjacent SP elements.

[0167] A surgeon can select the degree of adjacent SP separation and distraction by choosing hemi-spacers of increasing lengths.

[0168] In another embodiment, an interarticulating staple 100 can be provided for clamping one of a thoracic/lumbar Spinous Process (SP), a thoracic/lumbar Transverse Process (TP), and cervical Spinous Process (SP). The interarticulating staple 100 can include a top claw 110, a bottom claw 112, a staple pin 118 pivotally connecting the top claw 110 and the bottom claw 112, and ratchet means (e.g., 124, 128) fix limiting an opening force of the top claw 110 with respect to the bottom claw 112. The staple 100 can include spacer means (e.g., 130) on the top claw 110 and/or on the bottom claw 112 for providing adjacent spinous process separation and/or distraction. Upon the stapling of two adjacent spinous processes, the staple claws approximate, and the spacer means can be wedged between two adjacent spinous processes, thereby providing adjacent spinous process separation and/or distraction leading to spinal canal decompression and alleviation of the symptoms of spinal stenosis.

[0169] In another embodiment, an interarticulating staple 100 can be provided for clamping one of a thoracic/lumbar Spinous Process (SP), a thoracic/lumbar Transverse Process (TP), and cervical Spinous Process (SP). The interarticulating staple 100 can include first claw means (e.g., 110) pivotally connected to second claw means (e.g., 112); and ratchet means (e.g., 124, 128) for limiting an opening force of the first claw means (e.g., 110) with respect to the second claw means (e.g., 112) and fixing a position of the first claw means (e.g., 110) with respect the second claw means (e.g., 112); and spacer means (e.g., 130) on at least one of the first claw means (e.g., 110) and the second claw means (e.g., 112), the spacer means for providing one of adjacent spinous process separation and distraction. Upon the stapling of two adjacent spinous processes, the staple claws approximate, and the spacer means can be wedged between two adjacent spinous processes, thereby providing adjacent spinous process separation and/or distraction leading to spinal canal decompression and alleviation of the symptoms of spinal stenosis.

[0170] FIGS. 13A-B illustrate a lumbar facet joint staple 1200 in open and closed positions and having staple prongs 1203. This lumbar facet staple has been thoroughly described in Applicants' previous co-pending patent applications, Ser. No. 11/536,815, filed on Sep. 29, 2006, and Ser. No. 11/208,644, filed on Aug. 23, 2005, the relevant portion of each of which is hereby incorporated by reference hereinafter. The new improvement of this device includes a ratchet 1201. The staple 1200 can be incrementally closed with increased ratcheting over increasing number of spurs 1202. This achieves increasing calibrated levels of lumbar facet joint fusion, and conversely diminishing joint flexibility. This new designs further enhances the capacity to achieve flexible fusions in the lumbar spine.

[0171] 5. Exemplary Medical Device

[0172] FIGS. 14A-B illustrate an embodiment of a posterior lumbar facet staple having a flexure spring. FIGS. 15A-C illustrate an embodiment of a lumbar facet staple having a torsional spring. Features of a lumbar facet staple have been thoroughly described in the aforementioned related applications, the relevant portions of which are hereby incorporated by reference herein in their entirety. The embodiments illustrated in the related applications included a ratchet. The staple could be incrementally closed with increased ratcheting over increasing number of spurs. The present invention provides two evolved embodiments, which are superior to conventional designs in that the closing mechanisms can withstand much greater force (Newtons) than a small external ratchet. Other improvements will be described below.

[0173] FIGS. 14A-B illustrate an embodiment of a posterior lumbar facet staple 500 having a flexure spring 530. As shown in FIGS. 14A-B, the features of the staple 500 include top claws 510 and bottom claws 520 with ridges 570 to help incorporate and fuse with bone. A staple pin (pivot) 560 connects the top claws 510 and bottom claws 520. The staple 500 includes four fastener pins (prongs) 580, 582, 584, 586, two per top claw 510 or bottom claw 520, Ratchet teeth 540 are molded onto the lower claw 520, and a spring loaded ratchet pawl 530 pivots on the claw, and locks the staple 500 in position. As the staple 500 closes, the ratchet 540 works in standard fashion. When a force is applied to open the staple 500, the ratchet 540 locks up, but the ratchet pawl (e.g., the flexure spring) 530 acts as a spring due to its curvature. So depending on the material used for the ratchet spring, the ratchet spring 530 can deform more or less, thereby providing different degrees of resistance. The ratchet mechanism 540 limits the opening force of the staple 500 by a force proportional to the stiffness of the flexure spring 530 (e.g., ratchet pawl). The force can be tailored by making the pawl from different materials or varying the dimension of the flexure spring on the pawl. This embodiment can achieve significant rigidity (stiffness).

[0174] FIGS. 15A-C illustrate an embodiment of a posterior lumbar facet staple 600 having a torsional spring 630. FIGS. 15A-C illustrate features of the staple 600, which include top claws 610 and bottom claws 620 with ridges 670 to help incorporate and fuse with bone. A staple pin (pivot) 660 joins the upper claw 610 and lower claw 620 of the staple 600. The staple 600 includes four fastener pins (prongs) 682, 684, 686, 688, two per top claw 610 or bottom claw 620 of the staple 600. The features of the staple 600 include a torsional spring 630, a brake 680, and a pivot spring pin 640. As the staple 600 closes, the ratchet works in standard fashion. When the staple 600 is open, the spring does not interfere with the motion. Once the staple 600 is closed there is a ratchet mechanism (brake) 680 that engages with the spring 630. At that point, the force required to open the staple 600 will depend on the stiffness of the spring 630. Having staple models with different types of springs (e.g., soft, hard, etc.) allows the tailoring of different staples to the needs of a given patient. The embodiments of the present invention have less compliance than the conventional devices.

[0175] FIGS. 16A-6C illustrate an embodiment of a lumbar facet joint staple gun 700.

[0176] Features of lumbar facet joint staple guns have been thoroughly described. in the aforementioned related applications, the relevant portions of which are hereby incorporated by reference in their entirety. The exemplary staple gun 700 is an evolutionary advanced version compared to the conventional designs. An improved feature of the staple gun 700 includes a spring return 274 to bring the handles (e.g., upper and lower grips 712, 714) back to their original position after stapling, and a pull knob that opens the staple fingers (e.g., claws) to release the staple 760 at will. The staple 760 in this embodiment is released automatically when it is closed in addition, a return spring 774 is added to the handles (e.g., upper and lower grips 712, 714) so that the user does not have to reset the stapler manually each time it is used.

[0177] The FIGS. illustrate the staple gun 700, which includes two upper and lower grips 712, 714, upper and lower bars 722, 724, a cylinder 750, an opening connector 740, an opening rod 772, an opening lever or pull knob 730, a puller 726, a connector 740, a return spring 774, and pins 790, 792, 794.

[0178] 6. Surgical Method

[0179] Exemplary surgical steps for practicing one or more of the forgoing embodiments will now be described.

[0180] The surgical placement of the lumbar facet staples via a posterior facet lumbar staple gun is described in the aforementioned related applications. The surgical procedure for these staple embodiments with this staple gun embodiment is identical to that which has been previously described. The evolutionary advantages of these embodiments are explained above.

[0181] The present inventions may provide effective and safe techniques that overcome the problems associated with current transpedicular based cervical, thoracic and lumbar fusion technology, as well as anterior cervical, thoracic and lumbar plating technology, and for many degenerative stable and unstable spinal diseases. These inventions could replace much pedicle screw, and anterior plating based instrumentation in many but not all degenerative spine conditions.

[0182] The speed and simplicity of placement of posterior cervical and lumbar facet staples, placement of anterior and posterior lumbar intervertebral cage/BDFT screw constructs, and placement of anterior cervical cage/BDFT screw constructs far exceeds that of current pedicle screw and anterior spinal plating technology. Furthermore, these devices have markedly significantly decreased risk of misguided screw placement and hence decreased risk of neurovascular injury, and blood loss. In the cervical and lumbar spines, intervertebral cage/BDFT screw constructs and facet staples could be applied modularly in different combinations to achieve different degrees of rigidity (flexibility). Furthermore, the posterior cervical and lumbar staple technology is amenable to short same-day procedures performed under local/IV anesthesia with a rapid recovery time. The lumbar and cervical intervertebral cage/BDFT screw constructs all would have decreased recovery time, and more rapid return to work time compared to pedicle screw, and plating technology. These devices with great probability lead to similar if not equal fusion rates, with substantially less morbidity, and hence, overall, make them a major advance in the evolution of spinal instrumented technology leading to advances in the compassionate care of the spinal patient.

[0183] 7. Exemplary Medical Device

[0184] FIGS. 17A-17D illustrate an embodiment of a lumbar facet joint staple gun.

[0185] Features of lumbar facet joint staple guns have been thoroughly described in the aforementioned related applications, the relevant portions of which are hereby incorporated by reference in their entirety. The exemplary staple gun 400 is an evolutionary advanced version compared to the conventional designs. The changes incorporated herein facilitate easier insertion and removal of the staple 700 compared to our prior design. An improved feature of the staple gun is the design of an independent puller tip which can be swung open when the stapler is at its maximum open position.

[0186] The FIGS. illustrate the staple gun 400 which includes two upper and lower grips 404, 406, upper and lower bars 408, 410, a cylinder 418, a puller 414, a puller tip 402, a connector 418, a return spring 420, and pins 422.

[0187] In our previous design the user might have to force the staple hinge to fit into the loops (puller), and once the staple 700 was closed the user had to ply the staple hinge from the loops. To address this problem, one of the loops was made as an independent part which can be swung open when the stapler is at its maximum open position.

[0188] The following is the mechanism of its action: The user opens the stapler handles to their maximum. This forces the puller part 414 to stick out from the cylinder part 412. In that configuration, the puller tip 402 can be opened, and the user can insert the staple 700, and close the puller tip 402 (no force required). As the user closes the staple handles, the puller part 414 retracts into the cylinder part 412 which prevents the puller tip part 402 from opening. Thus there is no risk of the staple 700 becoming loose or falling off during surgery. Once the staple 700 has been closed, and is locked, the user can open once more the staple handles to their max to force the puller part out, and in that configuration, the puller tip 402 can be opened, and the staple 700 can be released. The release mechanism doesn't have a spring. The puller tip 402 can simply be opened only when the center shaft (puller) is extended completely. When the puller 414 is retracted (during stapling) the release (puller tip) is constrained by the surrounding geometry i.e. it cannot move. The main advantage of this mechanism is its simplicity. The spring 420 is for the return. The spring 420 pushes the puller out, so after the user staples, by pressing the handles together and pulling the center shaft in (puller), the spring 420 will force the puller 414 out and swing the handles open to reset the stapler.

[0189] For example, an aspect of the invention can include a staple gun fix a lumbar facet joint staple includes a handle having an upper bar 408 and a lower bar 410, each of the upper bar 408 and the lower bar 410 having a first and a free end, a hollow cylinder 412 body having a first end for receiving the lumbar facet joint staple and a second end adjacent to the handle, a connector 418 having a first end coupled to the hollow cylinder 412 body and a second end coupled to the handle such that the first end of each of the upper bar 408 and the lower bar 410 can be pivotably coupled to the connector 418, a puller 414 disposed in and extending through the hollow cylinder 412 body, wherein the puller 414 has a first end for receiving the lumbar facet joint staple and a second end adjacent to the handle, the second end of the puller 414 being coupled to the handle, and a puller tip 402 coupled to the first end of the puller 414, wherein the handle can be moveable from a closed position to an open position, a distance between the free end of the upper bar 408 and the free end of the lower bar 410 in the closed position being less than a distance between the free end of the upper bar 408 and the free end of the lower bar 410 in the open position, wherein the first end of the puller 414 and at least a part of the puller tip 402 are disposed inside the first end of the hollow cylinder 412 body when the handle is in the closed position, and wherein the first end of the puller 414 and at least a part of the puller tip 402 extend outside the first end of the hollow cylinder 412 body when the handle is in the open.

[0190] The puller tip 402 can be moveable between an open position and a closed position when the handle in the open position, and wherein the puller tip 402 is locked in the closed position by the first end of the hollow cylinder 412 body when the handle in the closed position. The puller tip 402 can include a first loop part and a second loop part, the first loop part and the second loop part for grasping sides of the lumbar facet joint staple, wherein the first loop part is movable with respect to the second loop part in a direction transverse to a longitudinal axis of the puller 414. The staple gun can include a spring return mechanism that biases the handle in the open position. The handle can include a linkage coupling the puller 414 to each of the upper bar 408 and the lower bar 410.

[0191] Features of cervical facet joint staples have been thoroughly described in the aforementioned related applications, the relevant portions of which are hereby incorporated by reference in their entirety.

[0192] More particularly, the lumbar staple has top and bottom claws which come together. The top part of the staple, beneath from where the staple prongs come out, has on either side, a circular protuberance with a hole in the center. A pin goes through this hole and through a hole in the lower staple claw thus connecting these two components which pivot around the pin to open and close the jaw of the staple. The protuberances on both sides of the staple can be fit snugly into the puller tip 402 of the staple gun.

[0193] Exemplary aspects of a staple are illustrated in FIGS. 18A-B and 19A-C.

[0194] FIGS. 18A-B illustrate an embodiment of a posterior lumbar facet staple having a flexure spring. FIGS. 19A-C illustrate an embodiment of a lumbar facet staple having a torsional spring. Features of a lumbar facet staple have been thoroughly described in the aforementioned related applications, the relevant portions of which are hereby incorporated by reference herein in their entirety. The embodiments illustrated in the related applications included a ratchet. The staple could be incrementally closed with increased ratcheting over increasing number of spurs. The present invention provides two evolved embodiments, which are superior to conventional designs in that the closing mechanisms can withstand much greater force (Newtons) than a small external ratchet. Other improvements will be described below.

[0195] FIGS. 18A-B illustrate an embodiment of a posterior lumbar facet staple 500 having a flexure spring 530. As shown in FIGS. 18A-B, the features of the staple 500 include top claws 510 and bottom claws 520 with ridges 570 to help incorporate and fuse with bone. A staple pin (pivot) 560 connects the top claws 510 and bottom claws 520. The staple 500 includes four fastener pins (prongs) 580, 582, 584, 586, two per top claw 510 or bottom claw 520. Ratchet teeth 540 are molded onto the lower claw 520, and a spring loaded ratchet pawl 530 pivots on the claw, and locks the staple 500 in position. As the staple 500 closes, the ratchet 540 works in standard fashion. When a force is applied to open the staple 500, the ratchet 540 locks up, but the ratchet pawl (e.g., the flexure spring) 530 acts as a spring due to its curvature. So depending on the material used for the ratchet spring, the ratchet spring 530 can deform more or less, thereby providing different degrees of resistance. The ratchet mechanism 540 limits the opening force of the staple 500 by a force proportional to the stiffness of the flexure spring 530 (e.g., ratchet pawl). The force can be tailored by making the pawl from different materials or varying the dimension of the flexure spring on the pawl. This embodiment can achieve significant rigidity (stiffness).

[0196] FIGS. 19A-C illustrate an embodiment of a posterior lumbar facet staple 600 having a torsional spring 630. FIGS. 19A-C illustrate features of the staple 600, which include top claws 610 and bottom claws 620 with ridges 670 to help incorporate and fuse with bone. A staple pin (pivot) 660 joins the upper claw 610 and lower claw 620 of the staple 600. The staple 600 includes four fastener pins (prongs) 682 684, 686, 688 two per top claw 61 or bottom claw 620 of the staple 600. The features of the staple 600 include a torsional spring 630, a brake 680, and a pivot spring pin 640. As the staple 600 closes, the ratchet works in standard fashion. When the staple 600 is open, the spring does not interfere with the motion. Once the staple 600 is closed there is a ratchet mechanism (brake) 680 that engages with the spring 630. At that point, the force required to open the staple 600 will depend on the stiffness of the spring 630. Having staple models with different types of springs (e.g., soft, hard, etc.) allows the tailoring of different staples to the needs of a given patient. The embodiments of the present invention have less compliance than the conventional devices.

[0197] 8. Surgical Method

[0198] Exemplary surgical steps for practicing one or more of the forgoing embodiments will now be described.

[0199] The surgical placement of the lumbar facet staples via a posterior facet lumbar staple gun (FIG. 17) is described in the aforementioned related applications. The surgical procedure for these staple embodiments with this staple gun embodiment is identical to that which has been previously described. The evolutionary advantages of these embodiments are explained above.

[0200] The present inventions may provide effective and safe techniques that overcome the problems associated with current transpedicular based cervical, thoracic and lumbar fusion technology, as well as anterior cervical, thoracic and lumbar plating technology, and for many degenerative stable and unstable spinal diseases. These inventions could. replace much pedicle screw, and anterior plating based instrumentation in many but not all degenerative spine conditions.

[0201] The speed and simplicity of placement of posterior cervical and lumbar facet staples, placement of anterior and posterior lumbar intervertebral cage/BDFT screw constructs, and placement of anterior cervical cage/BDFT screw constructs far exceeds that of current pedicle screw and anterior spinal plating technology. Furthermore, these devices have markedly significantly decreased risk of misguided screw placement and hence decreased risk of neurovascular injury, and blood loss. In the cervical and lumbar spines, intervertebral cage/BDFT screw constructs and facet staples could be applied modularly in different combinations to achieve different degrees of rigidity (flexibility). Furthermore, the posterior cervical and lumbar staple technology is amenable to short same-day procedures performed under local/IV anesthesia with a rapid recovery time. The lumbar and cervical intervertebral cage/BDFT screw constructs all would have decreased recovery time, and more rapid return to work time compared to pedicle screw, and plating technology. These devices with great probability lead to similar if not equal fusion rates, with substantially less morbidity, and hence, overall, make them a major advance in the evolution of spinal instrumented technology leading to advances in the compassionate care of the spinal patient.

[0202] The present invention has been described herein in terms of several preferred embodiments. However, modifications and additions to these embodiments will become apparent to those of ordinary skill in the art upon a reading of the foregoing description. It is intended that all such modifications and additions comprise a part of the present invention to the extent that they fall within the scope of the several claims appended hereto.