US2015374998A1PendingUtilityA1

Approval per use implanted neurostimulator

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Individually held — no corporate assignee on recordPriority: Jan 15, 2009Filed: Sep 9, 2015Published: Dec 31, 2015
Est. expiryJan 15, 2029(~2.5 yrs left)· nominal 20-yr term from priority
Inventors:Kellie FletcherBenjamin D. PlessAnthony V. CaparsoKenneth Horne
A61N 1/36142A61N 1/36128G06F 19/3406A61N 1/37247A61N 1/37282G16H 40/63A61N 1/36075A61N 1/37241
42
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Claims

Abstract

Methods and apparatus for delivering therapy from an implanted neurostimulator to a patient are provided. One feature is an external controller that acts as a gateway for therapy. The external controller can be a handheld controller that communicates wirelessly with the implanted neurostimulator. In some embodiments, the controller communicates with a database to determine a therapy approval status of the neurostimulator. Therapy can be approved by a physician prescription, or by prepayment, for example. In some embodiments, the neurostimulator is deactivated when no approved therapies remain.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A method of delivering therapy to a patient, comprising:
 implanting a neurostimulator on a sphenopalatine ganglion of the patient, wherein the neurostimulator is configured to:   check with an external controller a therapy approval status of the implanted neurostimulator on a database; and   deliver therapy to the patient if the therapy approval status of the implanted neurostimulator is approved.   
     
     
         2 . The method of  claim 1  wherein therapy is not delivered to the patient if the therapy approval status of the implanted neurostimulator is not approved. 
     
     
         3 . The method of  claim 2  wherein the therapy approval status is not approved if the database indicates that the implanted neurostimulator is deactivated. 
     
     
         4 . The method of  claim 2  wherein the therapy approval status is not approved if the database indicates payment is past due. 
     
     
         5 . The method of  claim 1  wherein the database is stored at a location separate from the external controller. 
     
     
         6 . The method of  claim 1  wherein the external controller is an external handheld controller. 
     
     
         7 . The method of  claim 1  wherein the external controller contains a list of deactivated and not approved neurostimulators, the method further comprising updating the list of deactivated and not approved neurostimulators. 
     
     
         8 . A method of approving therapy in a patient, comprising:
 implanting a medical device in the patient;
 approving a set number of approved therapies to be delivered from the medical device to the patient; and 
 deactivating the medical device when no approved therapies remain. 
   
     
     
         9 . The method of  claim 8  wherein the approving step further comprises approving a set number of therapies to be delivered from the medical device to the patient with a physician prescription. 
     
     
         10 . The method of  claim 8  wherein the approving step further comprises approving a set number of therapies to be delivered from the medical device to the patient with payment by the patient. 
     
     
         11 . The method of  claim 8  further comprising providing the patient with a handheld controller that is configured to check a therapy approval status of the medical device. 
     
     
         12 . The method of  claim 11  wherein the handheld controller is configured to direct the medical device to deliver therapy to the patient. 
     
     
         13 . The method of  claim 8  further comprising re-activating the medical device by approving an additional number of therapies to be delivered from the medical device to the patient. 
     
     
         14 . The method of  claim 8  further comprising storing a therapy approval status of the medical device on a database. 
     
     
         15 . The method of  claim 14  wherein the controller is configured to access the database to determine the therapy approval status of the medical device. 
     
     
         16 . The method of  claim 8  wherein the medical device is a neurostimulator. 
     
     
         17 . A system for delivering therapy to a patient, comprising:
 an implantable neurostimulator configured to deliver therapy to the patient;   a database containing a count of approval therapies of the implantable neurostimulator; and   an external controller in communication with the database and the implantable neurostimulator, the external controller configured to direct the implantable neurostimulator to deliver therapy to the patient if the therapy approval status of the implantable neurostimulator is approved.   
     
     
         18 . The system of  claim 17  wherein the implantable neurostimulator is sized and configured to be implanted on or near a sphenopalatine ganglion. 
     
     
         19 . The system of  claim 17  wherein the external controller is a handheld controller. 
     
     
         20 . The system of  claim 17  wherein the external controller is configured to update and store a list of the count of remaining approval therapies of the implantable neurostimulator. 
     
     
         21 . The system of  claim 17  wherein the external controller is in wireless communication with the implantable neurostimulator and the database. 
     
     
         22 . The system of  claim 17  wherein the therapy is electrical stimulation. 
     
     
         23 . The system of  claim 17  wherein the external controller is configured to deactivate the implantable stimulator if no approved therapies remain. 
     
     
         24 . The system of  claim 17  wherein the database is stored remotely from the implantable neurostimulator and the external controller. 
     
     
         25 . The system of  claim 8  wherein the set number of approved therapies comprises a pre-determined number of approved therapies. 
     
     
         26 . The system of  claim 17 , wherein the controller is configured to direct the database to deduct an approved therapy from the count of approved therapies when therapy is delivered to the patient. 
     
     
         27 . A method of delivering therapy to a patient, comprising:
 implanting a neurostimulator in the patient; and   providing the patient with a controller, wherein the controller is configured to:   check on a database a count of approved therapies of the neurostimulator;   
       if the count of approved therapies is greater than zero, deliver therapy from the implanted neurostimulator to the patient; and
 deduct an approved therapy from the count of approved therapies on the database.

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