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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.

FIG. 3 is a cross-sectional diagram of an implantable conditioning device implanted between the scalp and skull of a patient, and illustrating a technique for adding fluid to the implantable conditioning device.

FIG. 4 is a cross-sectional diagram of the implantable conditioning device shown in FIG. 4, following the addition of fluid.

FIG. 5 is a plan diagram of the top of a head of a patient, illustrating an exemplary implantation of a low-profile IMD in a trough.

FIG. 6 is a flow diagram illustrating a technique for identifying potential locations and implantation strategies for an implanted low-profile IMD.

FIG. 7 is a conceptual diagram illustrating use of image data to develop physical or virtual models.

FIG. 8 is a flow diagram further showing the use of image data to develop physical or virtual models, and constructing an IMD based on the models.

FIG. 9 is a flow diagram illustrating the use of image data to select an IMD for implantation in a patient.

FIG. 10 is a flow diagram illustrating selection of an implantation site for an IMD based upon image data showing the patient\'s scalp.

FIG. 11 is a flow diagram showing selection of an implantation site for an IMD as a function of skull contour data.

FIG. 12 is a flow diagram illustrating techniques for selection of an implantation site and an implantation strategy based on soft-tissue image data.

FIG. 13 is a flow diagram illustrating applying the techniques of the invention with an imaging system that uses hard- and soft-tissue image data.

DETAILED DESCRIPTION

FIG. 1 shows a patient 10 with a low-profile IMD 12 deployed beneath his scalp 14. In FIG. 1, IMD 12 is a neurostimulator that provides deep brain stimulation via leads 16A, 16B deployed in the brain of patient 10. In the example of FIG. 1, IMD 12 is deployed in proximity to site of stimulation therapy. IMD 12 may be used to treat any nervous system disorder including, but not limited to, epilepsy, pain, psychological disorders including mood and anxiety disorders, movement disorders (MVD) such as, but not limited to, essential tremor and Parkinson\'s disease and neurodegenerative disorders.

Although IMD 12 is depicted as a neurostimulator, the invention is not limited to applications in which the IMD is a neurostimulator. The invention may be employed with IMDs that perform any monitoring or therapeutic functions. The invention is not limited to IMDs that include leads deployed in the brain, but may also be employed with leads deployed anywhere in the head or neck including, for example, leads deployed on or near the surface of the skull, leads deployed beneath the skull such as near or on the dura mater, leads placed adjacent cranial or other nerves in the neck or head, or leads placed directly on the surface of the brain. Nor is the invention limited to IMDs that are coupled to electrodes. The invention may be employed with low-profile IMDs coupled to any sensing or therapeutic elements, such as temperature sensors or motion sensors. The invention may also be employed with different types of IMDs including, but not limited to, IMDs operating in an open loop mode (also referred to as non-responsive operation), IMDs operating in a closed loop mode (also referred to as responsive), and IMDs for providing monitoring and/or warning.

In the example of FIG. 1, IMD 12 is deployed beneath scalp 14 of patient 10, but on top of the cranium of patient 10. The invention may be applied to other types of implantation as well, such as implantation of IMD 12 in a trough cut into the cranium of patient 10.

FIG. 2 illustrates a typical implantation of IMD 12 shown in FIG. 1. In a typical implantation, the surgeon makes an incision 18 through the scalp 14 of patient 10, and pulls back the resulting flap of skin 20 to expose the desired area of the cranium 22. The incision may be a “C-flap” incision, for example. Patient 10 may be under local anesthetic. The surgeon drills holes, called “burr holes,” in the cranium and deploys leads 16 through the burr holes into the brain.

The surgeon typically places caps 24A and 24B, called “burr hole caps,” over the burr holes. A portion of the bodies of leads 16A and 16B, identified with reference numerals 26A and 26B, is deployed outside of the brain on the surface of skull 22. Before connecting leads 26A and 26B to IMD 12, the surgeon typically “manages” the leads. Lead management includes arranging the excess length of leads 16 using techniques such as coiling and anchoring with anchoring plates. In a typical implantation, the surgeon arranges the leads to provide some slack to reduce the risk of lead migration. In FIG. 2, leads 26A and 26B are depicted as coiled, and are anchored by anchoring plates 28A and 28B.

The surgeon implants IMD 12 between scalp 14 and skull 22. In one surgical procedure, the surgeon uses a tool to form a pocket beneath scalp 14 proximate to the burr holes, and positions IMD 12 in the pocket. The surgeon may fix IMD 12 to the cranium using an attachment mechanism such as bone screws. The surgeon closes skin flap 20 over IMD 12, and then staples or sutures the incision.

In FIG. 2, IMD 12 is a low-profile device, allowing it to be implanted between scalp 14 and skull 22, with little discomfort or adverse cosmetic consequences to patient 10. A low-profile IMD also typically lacks high protrusions with sharp corners that could cause skin erosion. IMD 12 comprises one or more modules that carry out the various functions of IMD 12. As shown in FIG. 2, IMD 12 includes at least three modules: a control module 30, a power supply module 32 and a recharge module 34. One or more of modules 30, 32, 34 includes a housing that can carry out a variety of functions, including encasing the components of the modules, sealing the modules against contamination, electrically isolating electrical components, and the like. The modules are coupled to a member 36, which may be made of a soft, biocompatible material. Member 36 at least partially encapsulates one or more housings of modules 30, 32, 34, and generally serves as a smooth interface between the modules and the body tissue. Leads 26A and 26B are coupled to IMD 12 at lead connectors 38A and 38B. IMD 12 may be anchored with an anchoring mechanism such as a metallic tab 40 that includes an opening for receiving a bone screw.

In general, member 36 integrates modules 30, 32 and 34 into a desired form factor, but, where flexible, allows relative intermodule motion. In some embodiments, member 36 incorporates mechanical features to restrict intermodule motion to certain directions or within certain ranges. Member 36 may be made from silicone, and is some embodiments may be made from two or more materials of differing flexibility, such as silicone and a polyurethane. An exemplary polyurethane for this purpose is Tecothane®, which is commercially available from Hermedics Polymer Products, Wilmington, Mass. Member 36 may also be referred to as an “overmold,” but use of the term “overmold” herein is not intended to limit the invention to embodiments in which member 36 is a molded structure. Member 36 may be a molded structure, or may be a structure formed by any process.

The invention is not limited to the particular IMD depicted in FIG. 2, but includes a number of embodiments, some of which are described in more detail below.

FIG. 3 is a cross-sectional view of the top of the head of a patient, and illustrates an embodiment of the invention. In some cases, scalp 14 may not be sufficiently elastic to close over IMD 12. Patient 10 may benefit from having the scalp stretched or conditioned prior to implantation of IMD 12. Stretching of the scalp can contribute to patient comfort, for example, as well as easier closure of the incision following implantation, along with attendant benefits such as a reduced risk of infection. Implantation of a dummy IMD 50 prior to implantation of working IMD 12 can help condition scalp 14.

A surgeon may implant dummy IMD 50 in a manner similar to implantation of a working IMD. For example, the surgeon may make a C-flap incision as shown in FIG. 2, and pull back the scalp flap to expose the skull. The surgeon may further separate a part of the scalp from the skull to create a pocket, and place at least a portion of dummy IMD 50 in the pocket. The surgeon covers at least a portion of dummy IMD 50 with the scalp flap and sutures the scalp flap to close the incision.

As illustrated in FIG. 3, dummy IMD 50 need not provide sensing or therapy. Rather, dummy IMD 50 is a device that is comparable in dimension to working IMD 12 (not shown in FIG. 3). In FIG. 3, dummy IMD 50 is implanted between scalp 14 and cranium 22, and covers about as much surface area of cranium 22 as would be covered by working IMD 12. In one embodiment, dummy IMD 50 is at the time of implantation thinner than working IMD 12. The thinness of dummy IMD 50 enables the surgeon to close the incision in scalp 14 more easily.

Dummy IMD 50 may be formed from any number of biocompatible materials. In a typical embodiment, dummy IMD 50 is formed from a soft, pliable and fluid-tight polymer such as silicone.

In the embodiment of the invention shown in FIG. 3, dummy IMD 50 does not have a fixed volume. Rather, dummy IMD 50 comprises an inflatable interior, such as a sac or pouch that can be expanded. The sac may comprise, for example, a self-sealing silicone envelope that can be increasingly filled with a fluid such as saline by injection through the scalp. FIG. 3 depicts an expansion technique, in which a hypodermic needle 52 injects fluid into the interior of dummy IMD 50.

FIG. 4 shows dummy IMD 50 with an expanded volume. In FIG. 4, the volume or profile of dummy IMD 50 may be comparable to the volume or profile of working IMD 12. Increased quantities of fluid may have been injected into dummy IMD 50 over time, causing scalp 14 to stretch gradually. The time for scalp conditioning may vary from patient to patient, but stretching may take place over about two weeks, in a typical patient. Gradual stretching of scalp 14 with expandable dummy IMD 50 may effectively pre-condition scalp 14 for the implantation of working IMD 12.



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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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