Implantation of implantable medical device

• US 7,596,399 B2
• Filed: 04/29/2004
• Issued: 09/29/2009
• Est. Priority Date: 04/29/2004
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Urquhart, Steven J., Singhal, Ruchika, Skime, Robert M., Wahlstrand, Carl D.
• Primary Examiner(s): Manuel; George
• Assistant Examiner(s): Flory; Christopher A
• Application Number:
  US10/835,527
• Publication Number:
  US 20050245806A1
• Time in Patent Office: 1,979 Days
• Field of Search: 128/898, 600/378, 600/451, 600/383, 607/9
• US Class Current: 600/383
• CPC Class Codes: A61B 5/107 Measuring physical dimensions, e.g. size of the entire body or parts thereof
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 5/6864 Burr holes
• CPC Class Codes: A61B 5/6868 Brain

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.

Claims

1. A method comprising:

receiving an image of a head of a patient;

determining, as a function of the image, whether the patient is a candidate for implantation of an implantable medical device, the implantable medical device including at least one module that includes control electronics within a housing, between a scalp and a skull of the patient, wherein the implantable medical device is configured to be implanted between the scalp and the skull of the patient; and

implanting at least the housing of the implantable medical device between the scalp and the skull of the patient in the event the patient is determined to be a candidate for the implantation,

wherein determining, as a function of the image, whether the patient is a candidate for implantation includes identifying, based on the image, one or more of skull curvature, skull thickness, scalp thickness, locations of one or more vascular structures within the scalp, or locations of one or more nerves within the scalp, and determining whether the patient is a candidate for implantation based on the one or more of the skull curvature, skull thickness, scalp thickness, locations of one or more vascular structures within the scalp, or locations of one or more nerves within the scalp.

2. The method of claim 1, wherein receiving the image comprises receiving an image generated by at least one of X-ray, magnetic resonance imaging, CT-scan or fluoroscopy.

3. The method of claim 1, further comprising determining, as a function of the image, whether the patient is a candidate for implantation of the implantable medical device, including the at least one module that includes control electronics within the housing, deployed in a recess created in the skull.

4. The method of claim 1, further comprising determining, as a function of the image, whether the patient is a candidate for implantation of the implantable medical device, the implantable medical device comprising a member that at least partially encapsulates the housing.

5. The method of claim 1, wherein determining, as a function of the image, whether the patient is a candidate for implantation includes evaluating, based on the image, whether there are any irregularities in the skull or the scalp of the patient that would impede implantation of the implantable medical device.

6. The method of claim 1, wherein the implantable medical device includes an implantable neurostimulator.

7. The method of claim 1, further comprising:

generating a model of the skull of the patient as a function of the image of the head of the patient; and

providing the implantable medical device as a function of the model of the skull.

8. The method of claim 7, wherein generating the model of the skull comprises generating a physical model of the skull.

9. The method of claim 8, wherein providing the implantable medical device comprises adjusting a standard configuration of the implantable medical device to fit the physical model of the skull.

10. The method of claim 9, wherein adjusting the standard configuration of the implantable medical device comprises flexing, bending or trimming the standard configuration of the implantable medical device.

11. The method of claim 7, wherein generating the model of the skull comprises generating a virtual model of the skull.

12. The method of claim 7, further comprising generating a virtual model of the implantable medical device, wherein providing the implantable medical device comprises providing the implantable medical device as a function of the virtual model of the implantable medical device.

13. The method of claim 7, wherein providing the implantable medical device comprises selecting, from a plurality of configurations of the implantable medical device, one of the configurations of the implantable medical device.

14. The method of claim 1, further comprising:

selecting, from a plurality of configurations of the implantable medical device, one of the configurations of the implantable medical device as a function of the image.

15. The method of claim 14, further comprising adjusting the selected implantable medical device to fit the skull of the patient.

16. The method of claim 15, wherein adjusting the selected implantable medical device comprises flexing, bending or trimming the implantable medical device.

17. The method of claim 14, wherein the plurality of configurations includes a configuration of at least three modules in a triangular configuration and a configuration of at least two modules in a linear configuration.

18. The method of claim 14, wherein selecting one of the configurations includes selecting the configuration as a function of one or more of skull curvature, skull thickness, scalp thickness, locations of one or more vascular structures, or locations of one or more neurological structures indicated by the image.

19. The method of claim 1,

wherein receiving an image of the head comprises receiving an image of a scalp of the patient;

and

wherein determining whether the patient is a candidate for implantation of the implantable medical device comprises determining, as a function of the image of the scalp, whether the patient is a candidate for implantation of the implantable medical device.

20. The method of claim 19, further comprising conditioning the scalp of the patient to receive the implantable medical device between the scalp and the skull.

21. The method of claim 20, wherein conditioning the scalp comprises:

making an incision in the scalp of a head of a patient to create a scalp flap;

exposing a skull beneath the scalp flap;

creating a pocket between the scalp and the skull; and

placing at least a portion of a dummy implantable medical device in the pocket the dummy implantable medical device having a first volume;

covering at least a portion of the dummy implantable medical device with the scalp flap;

suturing the scalp flap to close the incision; and

expanding the dummy implantable medical device to a second volume following suturing.

22. The method of claim 19, wherein receiving the image comprises receiving an image generated by at least one of magnetic resonance imaging or ultrasound.

23. The method of claim 19, wherein determining, as a function of the image, whether the patient is a candidate for implantation includes evaluating, based on the image, whether there are any irregularities in the scalp of the patient that would impede implantation of the implantable medical device.

24. The method of claim 1,

further comprising determining skull contour data based on the image of the head;

and

selecting, as a function of the skull contour data, an implantation site for the implantable medical device.

25. The method of claim 24, wherein selecting, as a function of the skull contour data, an implantation site includes evaluating, based on the data, one or more of skull curvature or skull thickness.

26. The method of claim 24, further comprising implanting the implantable medical device at the selected implantation site.

27. The method of claim 1, further comprising determining skull contour data based on the image of the head, wherein providing the implantable medical device comprises providing the implantable medical device as a function of the skull contour data.

28. The method of claim 1, wherein receiving the image of the head comprises receiving a soft-tissue image of the head of the patient, the method further comprising:

identifying physiological structures in the image; and

selecting an incision site as a function of the physiological structures.

29. The method of claim 28, wherein identifying the physiological structures comprises identifying at least one of a vascular structure or a neurological structure.

30. The method of claim 28, further comprising selecting a site for implantation of the implantable medical device based on the soft-tissue image.

31. The method of claim 28, further comprising making an incision at the selected incision site.

32. The method of claim 1, wherein receiving the image of the head of the patient comprises receiving a soft-tissue image and a hard-tissue image of the head of the patient, the method further comprising:

receiving an implantation criterion; and

proposing at least one implantation site for the implantable medical device between the scalp and the skull of the patient as a function of the image and the implantation criterion.

33. The method of claim 32, further comprising:

receiving a second proposed implantation site for the implantable medical device; and

disclosing to a user whether the second proposed implantation site satisfies the implantation criterion.

34. The method of claim 32, wherein the implantation criterion comprises one or more of skull curvature, skull thickness, scalp thickness, locations of one or more vascular structures, locations of one or more neurological structures, or potential incision locations.

35. The method of claim 1, wherein receiving the image of the head of the patient comprises receiving a soft-tissue image and a hard-tissue image of the head of the patient, the method further comprising:

receiving an implantation site for implantation of implantable medical device between the scalp and the skull of the patient; and

disclosing to a user information about at least one feature of the head at the implantation site.

36. The method of claim 35, further comprising disclosing to the user whether the implantation site satisfies an implantation criterion.

37. The method of claim 35, further comprising disclosing to the user information about adjusting a standard configuration of the implantable medical device as a function of the image and the implantation site.

38. The method of claim 37, wherein disclosing to the user information about adjusting the standard configuration of the implantable medical device comprises disclosing information about flexing, bending or trimming the standard configuration of the implantable medical device.

39. The method of claim 35, wherein the feature of the head comprises at least one of skull curvature, skull thickness, scalp thickness, a nearby vascular structure, a nearby neurological structure or a skull anomaly.

40. The method of claim 1, wherein determining, as a function of the image, whether the patient is a candidate for implantation includes evaluating, based on the image, one or more of skull curvature, skull thickness, scalp thickness, or locations of one or more vascular structures within the scalp and determining whether the patient is a candidate for implantation based on the one or more of the skull curvature, skull thickness, scalp thickness or locations of one or more vascular structures within the scalp.

41. A method comprising:

receiving an image of a head of a patient;

determining, as a function of the image, whether the patient is a candidate for implantation of an implantable medical device comprising at least one module that includes control electronics within a housing and a member that at least partially encapsulates the housing; and

implanting at least the housing of the implantable medical device between a scalp and a skull of the patient in the event the patient is determined to be a candidate for the implantation,

wherein determining, as a function of the image, whether the patient is a candidate for implantation includes identifying, based on the image, one or more of skull curvature, skull thickness, scalp thickness, locations of one or more vascular structures within the scalp, or locations of one or more nerves within the scalp, and determining whether the patient is a candidate for implantation based on the one or more of the skull curvature, skull thickness, scalp thickness, locations of one or more vascular structures within the scalp, or locations of one or more nerves within the scalp.

42. The method of claim 41, further comprising determining whether the patient is a candidate for implantation of the implantable medical device, including the at least one module that includes control electronics within the housing, deployed in a recess created in a skull of the patient.

43. The method of claim 41, wherein determining, as a function of the image, whether the patient is a candidate for implantation includes evaluating, based on the image, whether there are any irregularities in a skull or a scalp of the patient that would impede implantation of the implantable medical device.

44. The method of claim 41, wherein the implantable medical device includes an implantable neurostimulator.

45. The method of claim 41, wherein determining, as a function of the image, whether the patient is a candidate for implantation includes evaluating, based on the image, one or more of skull curvature, skull thickness, scalp thickness, or locations of one or more vascular structures within the scalp and determining whether the patient is a candidate for implantation based on the one or more of the skull curvature, skull thickness, scalp thickness or locations of one or more vascular structures within the scalp.

46. 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 configured to be implanted between a scalp and a skull of the patient, the implantable medical device comprising at least one module that includes control electronics within a housing,

wherein determining, as a function of the image, whether the patient is a candidate for implantation includes identifying, based on the image, one or more of skull curvature, skull thickness or scalp thickness, and determining whether the patient is a candidate for implantation based on the one or more of the skull curvature, skull thickness or scalp thickness;

wherein, if the patient is determined to be a candidate for implantation of the implantable medical device between the scalp and the skull of the patient, the method further includes implanting at least the housing of the implantable medical device between the scalp and the skull of the patient; and

wherein, if the patient is determined not to be a candidate for implantation of the implantable medical device between the scalp and the skull of the patient, the method further includes planning an implantation at another site within the patient.

47. 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 configured to be implanted between a scalp and a skull of the patient, the implantable medical device comprising at least one module that includes control electronics within a housing,

wherein determining, as a function of the image, whether the patient is a candidate for implantation includes identifying, based on the image, one or more of skull curvature, skull thickness, or scalp thickness, and determining whether the patient is a candidate for implantation based on the one or more of the skull curvature, skull thickness, or scalp thickness;

determining, as a function of the image, that the patient is not a candidate for implantation of the implantable medical device between the scalp and the skull of the patient; and

planning an implantation at another site within the patient.