Search

EP-3823561-B1 - SYSTEM TO FUSE BONE

EP3823561B1EP 3823561 B1EP3823561 B1EP 3823561B1EP-3823561-B1

Inventors

  • THABET II, Frederick J.
  • KANAGALA, Ravi
  • SEARLE, James

Dates

Publication Date
20260506
Application Date
20190719

Claims (12)

  1. An implant operable to be disposed between and fuse two sections of a bone, the implant comprising: an inner layer; and an outer layer surrounding the inner layer and operable to abut against the two sections of the bone, the outer layer being porous and/or fibrous and operable to receive at least one cellular growth factor, the outer layer being formed of a softer material relative to the inner layer.
  2. The implant of claim 1, wherein the outer layer includes a first portion and a second portion, the inner layer is sandwiched between the first and second portions of the outer layer.
  3. The implant of claims 1 or 2, wherein the outer layer is a soft tissue component wrapped around a circumference of the inner layer.
  4. The implant of any of preceding claims 1-3, wherein the inner layer and/or the outer layer includes at least a portion of at least one of the following: cortical bone fibers, cancellous bone fibers, collagen sponge, cortical bone graft, synthetic bone, and/or tissue graft.
  5. The implant of any of preceding claims 1-4, wherein the at least one cellular growth factor includes bone morphogenetic proteins, mesenchymal stem cells, blood, osteoclasts, osteoblasts, antibiotics, analgesics, and/or medications.
  6. The implant of any of preceding claims 1-5, wherein the inner layer is fenestrated to promote bony ingrowth.
  7. The implant of any of preceding claims 1-6, wherein the implant has a thickness between 2 millimeters and 100 millimeters.
  8. The implant of any of preceding claims 1-7, wherein the implant has a length between 25 millimeters and 250 millimeters.
  9. The implant of any of preceding claims 1-8, wherein the implant has a depth between 1 millimeter and 30 millimeters.
  10. The implant of any of preceding claims 1-9, further comprising one or more tacks extending from at least one of the inner layer or the outer layer and operable to couple with the bone.
  11. The implant of claim 10, wherein the one or more tacks includes bone tissue, vicryl, polypropylene, stainless steel, titanium, polyether ether ketone (PEEK), polyetherketone (PEK), polymers, metals, and/or poly(methyl methacrylate) (PMMA).
  12. The implant of any of preceding claims 1-11, wherein the inner layer includes two tabs which extend from each end of the outer layer, the tabs being operable to provide compression and stability to assist in anchoring the implant between the two sections of the bone.

Description

CROSS-REFERENCE TO RELATED APPLICATION This application claims the benefit of U.S. Provisional Patent Application No. 62/700,378, filed in the U.S. Patent and Trademark Office on July 19, 2018. BACKGROUND 1. Field of the Invention. The present inventive concept relates to systems and methods to heal and/or replace bone. In at least one example, the present inventive concept relates to an implant system and method to stabilize and fuse two halves of a sternum in a patient post-sternotomy. The method is not encompassed by the wording of the claims but considered as useful for understanding the invention. 2. Description of Related Art. Physical intervention in tissue of a human or an animal, for example surgery, dates to prehistoric times. During a surgical procedure, an incision is made to access the interior of the body and when the procedure is complete, the incision is closed to the external environment. Some parts of the body are not directly accessible via a simple incision and present additional challenges. For example, organs such as the heart and lungs are protected within the ribcage/thoracic cage. Thus, to access a patient's heart, a surgeon often needs to separate the sternum. The sternum or breastbone is a long, flat bone forming the middle portion of the front of the chest. Individual rib bones are connected along the sides of the sternum via cartilage to form the ribcage/thoracic cage which protects the heart, lungs, and major blood vessels from injury. The sternum is cut open in a sternotomy to gain access to the thoracic contents when performing cardiothoracic surgery. A sternotomy is a surgical procedure in which a midline longitudinal incision is made through at least a portion of the sternum to allow opposing halves/portions to be laterally separated to provide access to organs within the ribcage/thoracic cage. When the surgical procedure is complete, the separated halves/portions are aligned with and secured to one another and the incision closed. A variety of devices, compositions, and methods for assisting with closing and healing of sternotomy wounds can be utilized. The ideal goal for assisting with closing and healing of sternotomy wounds is complete rejoining of sternal portions with new bone growth in the absence of complications. Unfortunately, patient recovery from a conventional sternotomy is often slow and problematic. As the two sections (of the sternum) are brought back together by the surgeon, proper compression and a tight realignment of the end plates of the sternal surfaces is rarely achieved resulting in non-union, i.e. dehiscence, of separated sternal halves. This non-union allows for motion such as sliding of the surface of one sternal half against the surface of the other sternal half leading to significant pain for the patient and increased chance for development of infection. Additionally, the lack of proper compression leads to the formation of fibrous scar tissue instead of the desired new bone. If further surgical procedures are required, the scar tissue will have to be removed further complicating the procedure. Accordingly, there is a need for an improved system and method to reduce or eliminate the above-described shortcomings which will move one closer to the goal of a sternum completely healed by new bone growth. US 6 863 694 B1 discloses an osteogenic osteoimplant in the form of a flexible sheet comprising a coherent mass of bone-derived particles, the osteoimplant having a void volume not greater than about 32% and a method of making an osteogenic osteoimplant having not greater than about 32% void volume, the method comprising: providing a coherent mass of bone-derived particles; and, mechanically shaping the coherent mass of bone-derived particles to form an osteogenic osteoimplant in the form of a flexible sheet. SUMMARY The present inventive concept provides a system and method to fuse bone which has been separated or fractured into two sections. The method is not encompassed by the wording of the claims but considered as useful for understanding the invention. An implant is provided to be disposed between the two sections of the bone. The implant includes an inner layer including a cortical bone graft and an outer layer at least partially surrounding the inner layer. The implant is sized and shaped such that substantially all of the split surfaces of the two sections are compressed against the implant. Accordingly, the implant can accelerate and promote fusion of the bone. The aforementioned may be achieved in an aspect of the present inventive concept by providing an implant operable to be disposed between and fuse two sections of a bone. The implant may include an inner layer and an outer layer. The outer layer may at least partially surround the inner layer and may be operable to abut against the two sections of the bone. The outer layer may be porous and /or fibrous and may be operable to receive at least one cellular growth factor. The outer layer