Methods for creating, inserting, and removing an intramedullary sleeve system for bone treatment and stabilization
Inventors
Kolan, Krishna • Kollarigowda, Ravichandran • Saadatmanesh, Neda • Saadatmanesh, Hamid • Srinivasan, Abiraman
Assignees
Publication Number
US-11925394-B1
Publication Date
2024-03-12
Expiration Date
2043-05-04
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Abstract
An orthopedic intramedullary sleeve apparatus for internal bone fixation for bone fracture treatment of a patient. The apparatus may comprise a multilayer sleeve component comprising one or more access valves disposed on a surface of the sleeve. Each access valve may comprise one or more resealable ports for injecting polymers or monomers or resins or any curable types of cement. The sleeve component may be positioned inside the intramedullary cavity in a minimally invasive way and removed from the intramedullary cavity.
Core Innovation
The invention provides an orthopedic intramedullary sleeve apparatus designed for internal bone fixation to treat bone fractures. The apparatus comprises a multilayer sleeve component with one or more access valves disposed on its surface, each having resealable ports for injecting curable materials such as polymers, monomers, resins, or bone cement. The sleeve component is inserted inside the intramedullary cavity of a bone in a minimally invasive manner and may be removed subsequently.
The core innovation lies in the design of the intramedullary sleeve system that holds and cures injectable polymeric materials in situ to create a seamless structural unit that supports and bonds with the surrounding bone tissue during treatment. The multilayer sleeve may include an inner non-porous layer and an outer porous or non-porous layer made from biocompatible, resorbable or non-resorbable materials and can be customized to match the anatomical, mechanical, and physiological properties of the patient's bone. The system is designed to enable controlled polymer injection without air pockets and to allow insertion of light guides for polymer curing and ultrasonic tools for polymer removal.
The problem addressed is the need for improved, minimally invasive bone fracture fixation methods that avoid the side effects associated with traditional metal implants, such as chronic inflammation, metal debris, osteolysis, implant loosening, and the need for revision surgeries. Current implants often require large incisions and extensive rehabilitation, lack customization, and fail to provide removability or controlled polymer injection and curing. The present invention overcomes these limitations by providing a configurable, removable, and patient-specific intramedullary sleeve system that can be implanted via small surgical holes, conform to bone cavities, bond with bone, and allow for minimally invasive removal if desired.
The invention also features a unique multiport access valve comprising ports for both material injection and insertion of a light guide sealed by a flexible plug to prevent light escape, which enhances the efficiency of polymer injection and curing. The system can incorporate sensors for continuous monitoring and surface modifications for osseointegration and antimicrobial properties. The apparatus is adaptable for different bone types, fracture locations, and patient populations, including pediatric and geriatric cases, with manufacturing methods such as electrospinning, 3D printing, braiding, and weaving.
Claims Coverage
The patent includes multiple independent claims directed to the structure and methods involving the intramedullary sleeve apparatus and its application in bone fracture treatment. The following inventive features are extracted from these independent claims.
Intramedullary sleeve apparatus with multilayer structure and reinforcing interior
An intramedullary sleeve apparatus comprising an inner non-resorbable sleeve having a reinforcing material inside and access valves disposed at the proximal and distal ends, each valve having a first port for curable material injection and a second port for insertion of a light guide sealed by a flexible plug, enabling the curing of injectable bone cement or resin within the sleeve and configured for removal by external accessories.
Methods for minimally invasive insertion and removal of the intramedullary sleeve apparatus
Methods comprising creating laparoscopy holes in the bone, applying positioning guides to insert and position the multilayer intramedullary sleeve with access valves into the bone cavity, injecting curable material through the first valve port, inserting a light guide through the second valve port to cure the material, and techniques for removing the apparatus using mechanical tools or vacuum devices through the access valves after removal of cured material.
Layered sleeve system with surface modifications and embedded sensors
The apparatus having an outer intramedullary sleeve disposed around the inner sleeve, which can be porous or non-porous and surface modified for osseointegration, antimicrobial properties, and drug delivery, with one or more sensors on the outer or inner sleeve capable of measuring pressure, stress, strain, and temperature, fabricated concurrently by electrospinning, and designed to conform and stretch to match bone growth.
The claims collectively cover the intramedullary sleeve apparatus's multilayer construction with reinforcing materials, access valves featuring injection and light guide ports sealed by flexible plugs, surface modifications, embedded sensors, and methods for minimally invasive insertion, curing, and removal of the sleeve and cured materials, emphasizing customization to patient bone properties.
Stated Advantages
Minimally invasive bone fracture treatment reducing trauma and recovery time by insertion through small holes.
Elimination of metal implants prevents chronic inflammation, metal debris, osteolysis, implant loosening, and the need for revision surgeries.
Configurable, modular, and patient-specific solutions matching anatomical, mechanical, and physiological properties of bones.
Capability to bond with bone tissue and provide consistent structural support without compromising mechanical properties.
Allows controlled injection and curing of biocompatible polymers or resins inside the sleeve with no air pockets, enhancing implant integrity.
Enables insertion of light guides for efficient photopolymerization and ultrasonic probes for minimally invasive removal of cured polymer.
Sleeve systems with surface modifications for osseointegration, antimicrobial properties, and localized drug delivery to support healing.
The sleeve system can expand and stretch to accommodate bone growth, especially useful in pediatric applications.
Incorporation of sensors on the sleeve to monitor pressure, strain, temperature, and structural integrity of the implant in real-time.
Documented Applications
Internal bone fixation for treatment of bone fractures via intramedullary insertion of multilayer sleeve system.
Treatment and stabilization of fractures in long bones such as femur, tibia, humerus, radius, ulna, and small bones including phalanges.
Fracture fixation in pediatric patients with expandable auxetic sleeve design accommodating bone growth.
Fracture repair and strengthening in young adults, middle-aged, geriatric populations, and pathological fractures using customized sleeve properties matched to bone quality.
Use with injectable biocompatible polymer resins or bone cement systems cured in situ using light guides.
Minimally invasive removal or revision of bone fixation devices through access valves using mechanical tools or vacuum-assisted methods.
Drug delivery for osteostimulative factors and antimicrobials via surface-modified sleeves to support healing and prevent infection.
Continuous monitoring of implant parameters using embedded sensors to assess pressure, strain, and healing progression.
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