US-20260123941-A1 - SPINAL DECORTICATION AND GRAFTING

Abstract

A decortication and grafting device for lumbar fusion procedures includes a distal decortication tip and a tubular portion extending to a proximal handle. The tubular portion is configured to receive and allow passage of a bone graft material therethrough. A graft injection device coupled to the proximal handle of the decortication and grafting device injects graft material into the tubular portion which is then deposited on a bony surface decorticated by the decortication tip. A system for decortication and grafting further includes an access portal device defining a first lumen configured to slidably couple to an anchor device, such as a k-wire, and a second lumen configured to accommodate passage of various surgical instruments, such as a dilation device and the decortication and grafting device, and guide the instruments to a targeted surgical site.

Inventors

• Christopher U. Phan
• Joseph O'Brien
• Eric Feuchtbaum

Assignees

• PROVIDENCE MEDICAL TECHNOLOGY, INC.

Dates

Publication Date

20260507

Application Date

20231011

Claims (20)

1. 1 . A spinal decortication and grafting system, comprising: an access portal device defining a first lumen and a second lumen, each lumen extending longitudinally through a length of the access portal device, wherein the first lumen is configured to receive an anchoring device and the second lumen is configured to receive one or more surgical instruments; a decortication device comprising a tubular portion and a distal decortication member; and a graft injection device configured to couple with and push grafting material through the tubular portion of the decortication device, wherein the tubular portion of the decortication device is configured to extend into and through the second lumen of the access portal device until the decortication member is positioned at a targeted bony surface.
2. 2 . The system of claim 1 , wherein the anchoring device comprises a k-wire.
3. 3 . The system of claim 1 , wherein the anchoring device comprises an access chisel.
4. 4 . The system of claim 1 , wherein cross-sectional dimensions of the second lumen are greater than cross-sectional dimensions of the first lumen.
5. 5 . The system of claim 1 , wherein the graft injection device comprises a plunge member and a tubular portion defining an inner lumen, the plunge member configured to urge the graft material through the inner lumen in response to manual actuation.
6. 6 . The system of claim 1 , wherein the decortication device further comprises a handle attached to a proximal end of the tubular portion.
7. 7 . The system of claim 6 , wherein the handle defines a coupling component configured to couple to a distal end portion of the graft injection device.
8. 8 . The system of claim 7 , wherein the coupling component comprises a luer-thread fitting.
9. 9 . The system of claim 1 , wherein the distal decortication member comprises a plurality of serrated teeth or ridges configured to decorticate the targeted bony surface via rotation or scraping.
10. 10 . The system of claim 1 , wherein the distal decortication member comprises a substantially spherical burr covered in wavy ridges, serrated teeth or protrusions.
11. 11 . The system of claim 1 , further comprising a dilation device configured to extend through the second lumen, the dilation device comprising a tapered distal portion configured to spread apart tissue at or near the targeted bony surface.
12. 12 . The system of claim 1 , wherein the access portal device is configured to accommodate differently sized decortication devices having differently configured distal decortication members.
13. 13 . The system of claim 1 , wherein the targeted bony surface is a feature of a lumbar vertebrae.
14. 14 . A decortication device for spinal fusion procedures, the decortication device comprising: an elongate tubular portion configured to receive and facilitate passage of a graft material therethrough; a decortication member attached to a distal end of the elongate tubular portion and configured to decorticate a bony surface; and a handle member attached to a proximal end of the elongate tubular portion and configured to rotate the decortication member in response to manual actuation.
15. 15 . The decortication device of claim 14 , wherein the handle member defines a coupling component configured to couple to a graft injection device and receive the graft material ejected therefrom and the coupling component comprises a luer-thread fitting.
16. 16 . (canceled)
17. 17 . The decortication device of claim 14 , wherein the decortication member comprises a plurality of serrated teeth or ridges configured to decorticate the bony surface via rotation or scraping.
18. 18 . The decortication device of claim 14 , further comprising an adjustable depth stop on the tubular portion configured to prevent over-extension of the decortication member beyond the bony surface.
19. 19 . The decortication device of claim 14 , wherein the handle member comprises an angled body such that a coupling component defined by the handle member is angled with respect to a longitudinal axis of the elongate tubular portion.
20. 20 . The decortication device of claim 14 , wherein a distal portion of the elongate tubular portion is configured to curve or contort away from a longitudinal axis of the elongate tubular portion.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Application No. 63/415,093, filed Oct. 11, 2022, the disclosure of which is hereby incorporated by reference in its entirety. This application also claims the benefit of U.S. Provisional Application No. 63/449,126, filed Mar. 1, 2023, the disclosure of which is hereby incorporated by reference in its entirety. TECHNICAL FIELD This disclosure is directed to medical devices, systems and methods. More specifically, this disclosure is directed to devices, systems and methods related to spinal fusion procedures involving bone decortication and grafting. BACKGROUND Chronic back problems are one of the most common causes of pain and disability in the United States and other developed countries. Adverse spinal conditions may be characteristic of age. Conditions such as Degenerative Disc Disease (DDD) and spinal stenosis can result in a reduction of foraminal area (i.e., the available space for the passage of nerves and blood vessels), which may compress nerve roots and cause radicular pain. Spinal fusion, in which two adjacent vertebrae are fused together using plates, screws and other implants, is often performed to increase space (“spinal distraction”) and reduce motion between adjacent vertebrae, thereby preventing impingement of the spinal cord and nerve roots passing through openings in the vertebral column. One of the reasons that spinal fusion surgery is typically very invasive is that, due to the position of the spinal cord in back of (posterior to) the central vertebral bodies of the spine, many of the procedures require entering the patient through the front of the body (an anterior approach) and dissecting through various tissues to gain access to the spine. Fusion procedures performed on the lumbar spine, for instance, often require dissecting through the abdomen. Unfortunately, most techniques and devices used for performing spinal fusion are relatively invasive, high-risk, and necessitate difficult recovery and rehabilitation. Accordingly, a need exists for new, less invasive devices and methods for vertebral fusion. SUMMARY The present disclosure describes devices, systems and associated methods for spinal decortication and grafting. In accordance with embodiments of the present disclosure, a spinal decortication and grafting system may include an access portal device defining a first lumen and a second lumen, each lumen extending longitudinally through a length of the access portal device. The first lumen may be configured to receive an anchoring device and the second lumen may be configured to receive one or more surgical instruments. The system may also include a decortication device having a tubular portion and a distal decortication member. A graft injection device configured to couple with and push grafting material through the tubular portion of the decortication device may also be included. The tubular portion of the decortication device may be configured to extend into and through the second lumen of the access portal device until the decortication member is positioned at a targeted bony surface. In some examples, the anchoring device includes a k-wire. In some examples, the anchoring device includes an access chisel. In some examples, the cross-sectional dimensions of the second lumen are greater than the cross-sectional dimensions of the first lumen. In some examples, the graft injection device may include a plunge member and a tubular portion defining an inner lumen, the plunge member configured to urge the graft material through the inner lumen in response to manual actuation. In some examples, the decortication device further comprises a handle attached to a proximal end of the tubular portion. In some examples, the handle defines a coupling component configured to couple to a distal end portion of the graft injection device. In some examples, the coupling component includes a luer-thread fitting. In some examples, the distal decortication member includes a plurality of serrated teeth or ridges configured to decorticate the targeted bony surface via rotation or scraping. In some examples, the distal decortication member includes a substantially spherical burr covered in wavy ridges, serrated teeth or protrusions. In some examples, the system may also include a dilation device configured to extend through the second lumen, the dilation device including a tapered distal portion configured to spread apart tissue at or near the targeted bony surface. In some examples, the access portal device is configured to accommodate differently sized decortication devices having differently configured distal decortication members. In some examples, the targeted bony surface is a feature of a lumbar vertebrae. In accordance with embodiments of the present disclosure, a decortication device for spinal fusion procedures includes an elongate tubular portion configured to receive and facilitate passage of a graft