EP-4734866-A2 - IMPLANT FOR SUPPORTING ANATOMIC STRUCTURES

Abstract

An implant material for use in stabilizing anatomic structures comprises a plurality of fenestrated shells. The anatomic structures may be bone defects, vertebral bodies, or spinal disks. The implant material may further comprise a particulate filler material that may comprise particulate bone.

Inventors

• ALLEYNE, NEVILLE

Assignees

• Osteoagra LLC

Dates

Publication Date

20260506

Application Date

20240627

Claims (20)

1. 1 . An implant material for use in stabilizing a vertebral body, wherein the implant material comprises a plurality of fenestrated shells.
2. 2. The implant material of claim 1 , wherein each of the plurality of fenestrated shells defines an interior region, and wherein the interior region of at least some of the plurality of shells comprises bone.
3. 3. The implant material of claim 1 , wherein each of the plurality of fenestrated shells defines an interior region, and wherein the interior region of at least some of the plurality of shells comprises a particulate material.
4. 4. The implant material of claim 3, wherein the particulate material comprises bone particles.
5. 5. The implant material of claim 3, wherein the particulate material comprises polymer particles.
6. 6. The implant material of any one of claims 1 to 5, wherein at least some of the plurality of fenestrated shells comprise metal.
7. 7. The implant material of any one of claims 1 to 5, wherein at least some of the plurality of fenestrated shells comprise polymer.
8. 8. The implant material of any preceding claim, wherein the implant material comprises bone morphogenic protein.
9. 9. The implant material of any preceding claim, wherein at least some of the plurality of fenestrated shells comprises an interior volume devoid of solid shell material.
10. 10. The implant material of claim 10, wherein within the outer surface of the at least some of the plurality of fenestrated shells is less than 90% solid shell material by volume.
11. 11 .The implant material of claim 10, wherein within the outer surface of the at least some of the plurality of fenestrated shells is less than 75% solid shell material by volume.
12. 12. The implant material of claim 10, wherein within the outer surface of the at least some of the plurality of fenestrated shells is less than 50% solid shell material by volume.
13. 13. The implant material of claim 10, wherein within the outer surface of the at least some of the plurality of fenestrated shells is less than 25% solid shell material by volume.
14. 14. The implant material of any one of claims 9 to 13, wherein the at least some of the plurality of fenestrated shells each have a largest diameter of 5 mm or less.
15. 15. The implant material of claim 14, wherein the at least some of the plurality of fenestrated shells each have a smallest diameter of 0.2 mm or less.
16. 16. The implant material of any one of claims 1 to 8, wherein at least some of the plurality of fenestrated shells each have a largest diameter of 5 mm or less.
17. 17. The implant material of claim 16, wherein at least some of the plurality of fenestrated shells each have a smallest diameter of 0.2 mm or less.
18. 18. The implant material of any preceding claim, wherein the implant material comprises titanium particles.
19. 19. The implant material of any preceding claim, wherein the implant material comprises collagen particles.
20. 20. The implant material of any preceding claim, wherein the implant material comprises hydrogel beads.

Description

IMPLANT FOR SUPPORTING ANATOMIC STRUCTURES BACKGROUND [0001] Osteoporosis has continued to be a ubiquitous problem, especially in the elderly population. It is said that osteoporosis sufferers outnumber patients in the United States who have had Ml's, stroke, and breast cancer combined. Osteoporosis can result in compression fractures of the vertebral bodies of the spinal column. As shown in FIG. 1 , these fractures 10 generally occur in the anterior portion of the vertebra, with this portion compressing to a smaller height than a normal vertebral body. With increasing numbers of osteoporotic compression fractures of the thoracic and lumbar spine, it is felt that 1 in 3 women and 1 in 5 men will have an osteoporotic fracture in their lifetime. By 2020, osteoporosis is expected to affect approximately 14 million people in the United States. These fractures become more common obviously in older population and current treatment recommendations include vertebroplasty which can be done as an outpatient and kyphoplasty, which requires an in hospital stay of approximately one day. [0002] PMMA, poly methacrylate, is the substance used in both vertebroplasty and kyphoplasty. This material has been used throughout orthopedics for over 35 years. The first total hip replacements done by Dr. Charnley in Boston utilized a methacrylate. This material is also known as bone cement and its modulus of elasticity is much higher than that of cancellous or cortical bone. When this material is placed into a vertebral body and is allowed to cure, it creates an exothermic reaction, which can sometimes deaden or destroy nociceptin fibers and once it is hardened, it provides rigid support of the vertebra. Unfortunately, the remaining part of the vertebra and the part in which the cement has been placed cannot grow new bone. The exothermic reaction, if it is close to the endplate, can cause avascular necrosis and result in endplate fracture and adjacent segment collapse. Some of the issues that are associated with the use of PMMA include, but are not limited to, cord compression from ectopic cement extending from the vertebral body into the spinal canal, extrusion of cement through the cartilaginous endplate into the disc, allergic reaction to PMMA, coagulopathy, PMMA getting into the basivertebral sinus resulting in pulmonary emboli and infection because of the foreign body. These are some of the related complications that can occur with vertebroplasty or kyphoplasty. Furthermore, what we have seen over the years is that the cement, which does decrease pain, also appears to cause adjacent segment fractures at a later date. Some as early as a few months and others within a few years. The reason for these compression fractures is: 1 ) underlying osteoporosis throughout the vertebral bodies. 2) cement having a higher density than the cortical or cancellous bone and adjacent microfracturing, which may not have been detected at the time of the initial procedure involving the adjacent vertebra. In addition, compression fractures at TS or above are technically difficult due to the small pedicle and the parallel orientation of these pedicles. The thoracic spine is also very vulnerable in the event the cement is extruded, which could result in myelopathy or paresis or plegia. [0003] It should be noted that this Background is not intended to be an aid in determining the scope of the claimed subject matter nor be viewed as limiting the claimed subject matter to implementations that solve any or all of the disadvantages or problems presented above. The discussion of any technology, documents, or references in this Background section should not be interpreted as an admission that the material described is prior art to any of the subject matter claimed herein. SUMMARY [0004] In one implementation, an implant material for stabilizing a vertebral body comprises a plurality of fenestrated shells. In another implementation, an implant material for stabilizing a spinal disk comprises a plurality of fenestrated shells. The implant material in either case may further comprise a particulate filler material that may comprise particulate bone. Methods of implanting these materials into vertebral bodies and/or spinal disks are also provided. [0005] It is understood that various configurations of the subject technology will become apparent to those skilled in the art from the disclosure, wherein various configurations of the subject technology are shown and described by way of illustration. As will be realized, the subject technology is capable of other and different configurations and its several details are capable of modification in various other respects, all without departing from the scope of the subject technology. Accordingly, the summary, drawings and detailed description are to be regarded as illustrative in nature and not as restrictive. BRIEF DESCRIPTION OF THE DRAWINGS [0006] Various embodiments are discussed in detail in conjunction with the F