PRIORITY CLAIM TO EARLIER APPLICATIONS

[0001] The present invention is based on, and claims priority to, provisional U.S. Application Serial No. 61/160,639, entitled Lung Nodule Management, filed March 16, 2009, the entirety of which is incorporated by reference herein.

BACKGROUND

[0002] In the US alone, it is estimated that presently over 3 million people have a lung nodule that should be tested for malignancy. These patients are often at risk because they are smokers but there are other patients with lung lesions due to Histoplasmosis or other diseases that need diagnoses.

[0003] There is no accepted method of screening "at risk" patients for lung nodules, so often the lung nodules are found by chance on a CT Scan. Once a person is found to have a lung nodule, there is no protocol in place as to where the person should go for the management of their diagnosis (and potentially their treatment). The management of the nodule is often dictated by the physician that ordered the CT in the first place. Thus, a person may end up going to a surgeon for a surgical biopsy, a Radiologist for serial CT scans or a needle biopsy or to a Pulmonologist for a Bronchoscopy, depending on the choice of the physician that first detected the nodule. As a result, the effectiveness of the post-discovery efforts are very dependent on the choice made by the particular physician.

[0004] Thus in the US alone with the lack of lung nodule screening and fragmented care, the survival rate for a person that with a lung nodule that is malignant is only 15% over 5 years and this rate has not changed since the 70's.

[0005] This extremely low survival rate gives rise to an urgent need for a patient-care protocol that tracks lung nodules in such a manner to maximize efficiency and effectiveness. DESCRIPTION OF THE PRESENT INVENTION

[0006] Given the low survival rate, it is imperative that, once diagnosed with a lung nodule, a patient be given the most effective care possible in a most efficient manner. Optimally, a protocol will be established for lung nodules that ensures effective and efficient care.

[0007] One aspect of the present invention provides a data management system that results in improved management of a patient from the first time the nodule is detected on CT. By getting patients to a medical center with the latest, minimally invasive techniques to diagnose and treat a lesion, the lesion may be detected at its earliest, most treatable stage.

[0008] This aspect of the present invention results in the progression of a patient to a more stable "continuum of care" that gets and/or keeps a patient moving appropriately in the continuum. The continuum of care preferably includes at least the following three phases: (1 ) the "Nodule Management Phase", (2) the "Nodule Diagnosis Phase", and (3) the "Nodule Treatment Phase"

[0009] The Nodule Management Phase is a phase in which the physician and the patient must decide if the nodule that has been detected is appropriate for biopsy immediately, at a later date or never. Thus the physician will decide with the patient whether or not to enter the next phase. This is the phase where a patient and physician can face a great deal of confusion in deciding whether to wait or proceed to the diagnostic phase.

[0010] The Nodule Diagnostic Phase is the phase in which the nodule is biopsied. Presently, the Applicant's planning software offers a solution in this phase. By using Applicant's present planning software, the physician can plan the minimally invasive bronchoscopy procedure for any central lesions and use an electromagnetic navigation system, such as the Applicant's inReach® Navigation System, for peripheral nodules.

[0011] The Treatment Phase is entered in the event a patient receives a malignant diagnosis during the diagnostic phase. In the Treatment Phase, the physician can use the present invention in conjunction with a navigation system to place radiosurgical markers or take therapeutic steps to treat the lesion, such as ablation, for example.

[0012] As stated above, presently the Applicant's system only plays a role in phases (2) and (3). One aspect of the present invention expands the use of planning software, such as the Applicant's inReach® planning software, to include phase (1 ) as well. As such, the planning software, according to the present invention, becomes a full "lung nodule management and planning software" solution. This will allow the hospital center to capture the patient at the point of time when the lesion has been detected on CT and to direct the patient appropriately to Biopsy and treatment in a timely and effective manner

[0013] Another aspect of the present invention provides management and planning software designed such that the patient's lung nodule care is integrated from the time of first detection through final treatment phase (if needed). The software is designed to integrate into other electronic medical records systems.

[0014] The management and planning system of the present invention provides any or all of at least the following features:

[0015] (a) a 3D View of CT images for automatic lesion detection to assist a center as the patient first presents with a lesion on CT. This feature ensures there are no other lesions on the CT that were missed. Additionally, if the patient is given repeat CTs in order to watch a suspicious lesion, the software preferably compares the new CT to prior CTs and alert the physician of new findings.

[0016] (b) a 3D View of CT for volumetric nodule measurements used for the initial assessment of the lesion for the probability of malignancy. The subsequent CT scans volumes can be measured and compared.

[0017] (c) a patient management database (Electronic Medical Record) used for managing the patient over time, minimally through each phase of care. Some of the data collected preferably includes: • Patient demographics & risk factors

• Patient co-morbidities

• Storage of all CT & 3D images

• Automatic calculator of time to next CT, if needed

[0018] (d) an integrated "Pretest probability of malignancy calculator" or Nodule guidelines, which is a risk calculator for the patient record to determine if the risk is high enough to proceed to biopsy.

[0019] The system of the present invention includes software features application to the diagnostic phase that includes at least any or all of the following:

[0020] (a) 3D views, lung "tree" and virtual bronchoscopies for all bronchoscopies and peripheral nodules planned on the software.

[0021] (b) Navigation history for the procedure.

[0022] (c) Electronic record of any complications.

[0023] (d) A patient outcomes database from the navigation procedure, preferably including information such as diagnostic outcome (benign or malignant), time to accomplish the procedure, and lymph node staging.

[0024] The system of the present invention includes software features application to the treatment phase that includes at least any or all of the following:

[0025] (a) Automatic volumetric measurement of a nodule on CT to evaluate treatment efficacy.

[0026] (b) Integration of dose planning from the radiation oncology treatments.

[0027] In addition to these features specific to the phases, one aspect of the present invention provides capabilities such as data sharing between physicians. Preferably, and more specifically, some of the data sharing features of the present invention include: • Databases for publication and research purposes

• Automatic preservation of anonymity of any patient data for purposes of privacy

• Data reporting tools which may include number of patients in the center, their stage and outcomes, etc.

• Data field flagging making each patient file searchable by any of the fields contained therein. Hence, a physician could search all of the patient files contained in the database the present invention.

• Ability to link to other sites (publications, video files, photo files, applications, etc.) for physician interaction on specific patient cases.

• A messaging capability that allows physicians "visiting" other patient files to contact the other physician assigned in order to collaborate thoughts, findings, inquiries, etc.

[0028] Implementation:

[0029] The implementation of the present invention is flexible and varied. For example, one method of implementation includes a hospital-based system in which the software and licensing of the present invention is sold to the hospital for their system. This implementation allows all the DICOM images to be transferred to the software and downloaded to the Navigation system as necessary via the hospital PACs system.

[0030] Another example of an implementation of the present invention is an internet- based solution in which all patient data is stored in secure servers managed by a provider of the software. The hospital would download and access the data via the internet.

[0031] Although the invention has been described in terms of particular embodiments and applications, one of ordinary skill in the art, in light of this teaching, can generate additional embodiments and modifications without departing from the spirit of or exceeding the scope of the claimed invention. Accordingly, it is to be understood that the descriptions herein are proffered by way of example to facilitate comprehension of the invention and should not be construed to limit the scope thereof.