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Implantation of implantable medical device

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Title: Implantation of implantable medical device.
Abstract: In general, the invention is directed to strategies pertaining to implantation of an implantable medical device between a scalp and a skull of the patient. The invention pertains to collection of data such as data pertaining to the skull of the patient, the scalp of the patient, the vascular structure or neurological structures in the head of the patient, and the like. The data may be in the form of images, such as images generated by X-ray, magnetic resonance imaging, CT-scan and fluoroscopy. A surgeon can use the collected data to determine, for example, whether the patient is a candidate for a cranial implantation, whether the patient's skull and scalp can support the implantation, what configuration of device should be implanted, where the device should be implanted, and how the surgical incisions should be made. ...


USPTO Applicaton #: #20090299164 - Class: 600377 (USPTO) - 12/03/09 - Class 600 
Surgery > Diagnostic Testing >Structure Of Body-contacting Electrode Or Electrode Inserted In Body >Electrode Placed In Body >Electrode Implanted In Body

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The Patent Description & Claims data below is from USPTO Patent Application 20090299164, Implantation of implantable medical device.

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This application is a divisional of and claims priority to U.S. patent application Ser. No. 10/835,527, filed Apr. 29, 2004, the entire content of which is incorporated herein by reference.

TECHNICAL FIELD

The invention relates to implantation and removal of medical devices, and more particularly, to implantable medical devices that deliver therapy to and/or monitor a patient.

BACKGROUND

Implantable medical devices (IMDs) include devices implantable in a mammalian body that sense medical parameters, monitor medical conditions, administer therapy, or any combination thereof. Typical IMDs include a variety of electrical and/or mechanical components, often including a housing that houses the components. Because the components may be fragile, the housing is usually sufficiently robust to protect the components from forces to which they would otherwise be exposed when implanted within the body. Housings may be constructed from titanium, for example. In order to avoid potentially harmful interactions between the components and bodily fluids, such as corrosion, IMD housings are typically hermetically sealed.

Large components common to most IMDs typically include a battery, a coil, and a hybrid circuit that includes digital circuits, e.g., integrated circuit chips and/or a microprocessor, and analog circuit components. IMDs may include other components as well. The components and the housing each add bulk to the IMD.

Some medical devices may be implanted in the head of a patient. For example, an IMD may be implanted under the scalp and on top of the cranium, with one or more leads deployed on the head or implanted in the brain. In many cases, the implantation is not permanent, and it may be advantageous to remove the device for reasons such as repair, maintenance, replacement, or because the patient no longer benefits from the device.

SUMMARY

In general, the invention is directed to techniques for planning and carrying out implantation of an IMD under the scalp of a patient and on top of the patient\'s skull. Implantation of a cranially implanted IMD includes making an incision in the scalp of a head of a patient to obtain access to the implantation site and implanting the IMD.

The invention addresses strategies that make implantation more efficient and improve the chances of success. Generally speaking, data are collected prior to surgery that assist the surgeon in planning and executing the surgery. The collected data can pertain to the contours of the skull of the patient, the condition of the scalp of the patient, the vascular structure or neurological structures in the head of the patient, and the like. The data may be in the form of images, such as images generated by X-ray, magnetic resonance imaging, CT-scan and fluoroscopy. The data can also be in the form of physical or virtual models of the patient\'s skull and the IMD.

A surgeon can use the collected data to determine, for example, whether the patient is a candidate for a cranial implantation, and whether the patient\'s skull and scalp can support the implantation. The surgeon can also determine where the device should be implanted, and how the surgical incisions should be made.

In addition, the surgeon can use the data to determine what configuration of device should be implanted. The IMDs can incorporate a modular design, and the modules may be arranged in a plurality of standard configurations. In other words, IMDs need not be built from scratch for every patient. Rather, the surgeon can select a suitable standard configuration and adapt that configuration to the patient by bending, trimming or otherwise adjusting the IMD to fit the patient. Use of one or more standard configurations is generally more efficient, convenient and economical than building custom IMDs from scratch for each patient.

In one embodiment, the invention is directed to a method comprising receiving an image of a head of a patient and determining, as a function of the image, whether the patient is a candidate for implantation of an implantable medical device between a scalp and a skull. The IMD includes at least one module that includes control electronics within a housing, and is configured to be implanted between the scalp and the skull of the patient. The IMD may also have member that at least partially encapsulates the housing. The method may further include determining whether the patient is a candidate for implantation of the IMD deployed in a recess created in the skull.

In another embodiment, the invention is directed to a method that includes receiving an image of a head of a patient, generating a model of the patient\'s skull as a function of the image, and providing an implantable medical device configured to be implanted between a scalp and the skull of the patient as a function of the model of the skull. The model of the skull may be a physical model or a virtual model simulated in a computer.

In a further embodiment, the invention presents a method comprising receiving an image of a head of a patient and selecting, from a plurality of configurations of an implantable medical device configured to be implanted between a scalp and a skull, a configuration of the implantable medical device as a function of the image.

In an additional embodiment, the invention is directed to a method that includes receiving an image of a scalp of a patient. The method also includes determining, as a function of the image, whether the patient is a candidate for implantation of an implantable medical device between the scalp and a skull. The method can include conditioning the scalp for implantation of the IMD.

In another embodiment, the invention is directed to a method comprising receiving skull contour data associated with the skull of a patient, and selecting, as a function of the skull contour data, an implantation site for an implantable medical device.

In an added embodiment, the invention is directed to a method that includes receiving a soft-tissue image of a head of a patient, identifying physiological structures in the image, and selecting an incision site as a function of the physiological structures.

In additional embodiments, the invention is directed to methods that include receiving an image of a head of a patient, the image comprising a soft-tissue image and a hard-tissue image, of a head of a patient. In one embodiment, the invention includes receiving an implantation criterion and proposing at least one implantation site for an implantable medical device as a function of the image and the implantation criterion. In another embodiment, the invention includes receiving an implantation site for an implantable medical device, and disclosing to a user information about at least one feature of the head at the implantation site.

The details of one or more embodiments of the invention are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the invention will be apparent from the description and drawings, and from the claims.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 is a conceptual diagram illustrating deployment of a low-profile IMD under the scalp of a patient.

FIG. 2 is a plan diagram of the top of a head of a patient, illustrating an exemplary implantation of a low-profile IMD.



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stats Patent Info
Application #
US 20090299164 A1
Publish Date
12/03/2009
Document #
12538617
File Date
08/10/2009
USPTO Class
600377
Other USPTO Classes
600407
International Class
/
Drawings
11


Cranial
Fluoroscopy
Implantable Medical Device
Incision
Magnetic Resonance
Magnetic Resonance Imaging
Neurological
Skull
Surgeon


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