Implantation of implantable medical device

• US 20050245806A1
• Filed: 04/29/2004
• Published: 11/03/2005
• Est. Priority Date: 04/29/2004
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Singhal, Ruchika, Skime, Robert M., Wahlstrand, Carl D., Urquhart, Steven J.
• Granted Patent: US 7,596,399 B2
• Time in Patent Office: Days
• US Class Current: 600/407
• 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; 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 of the patient, the implantable medical device comprising at least one module that includes control electronics within a housing, the implantable medical device configured to be implanted between a scalp and a skull of the patient.

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 whether the patient is a candidate for implantation of the implantable medical device 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, further comprising implanting 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.

6. 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, locations of one or more vascular structures, or locations of one or more neurological structures.

7. 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.

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

9. A method comprising:

receiving an image of a head of a patient;

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

providing an implantable medical device configured to be implanted between a scalp and the skull of a patient as a function of the model of the skull.

10. The method of claim 9, wherein generating the model of the skull comprises generating a physical model of the skull.

11. The method of claim 10, wherein providing the implantable medical device comprises adjusting a standard configuration of the implantable medical device to fit the physical model of the skull.

12. The method of claim 11, wherein adjusting the standard configuration of the implantable medical device comprises flexing, bending or trimming the standard configuration of the implantable medical device.

13. The method of claim 9, wherein generating the model of the skull comprises generating a virtual model of the skull.

14. The method of claim 9, 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.

15. The method of claim 9, wherein the implantable medical device includes an implantable neurostimulator.

16. The method of claim 9, 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.

17. 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.

18. The method of claim 17, further comprising adjusting the selected implantable medical device to fit the skull of the patient.

19. The method of claim 18, wherein adjusting the selected implantable medical device comprises flexing, bending or trimming the implantable medical device.

20. The method of claim 17, wherein each configuration of the implantable medical device comprises:

at least one module that includes control electronics within a housing; and

a member that at least partially encapsulates the housing.

21. The method of claim 20, 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.

22. The method of claim 17, wherein selecting an implantable medical device includes selecting the implantable medical device 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.

23. The method of claim 17, wherein the implantable medical device includes an implantable neurostimulator.

24. A method comprising:

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

25. The method of claim 24, further comprising conditioning the scalp of the patient to receive the implantable medical device between the scalp and the skull.

26. The method of claim 25, 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.

27. The method of claim 24, wherein receiving the image comprises receiving an image generated by at least one of magnetic resonance imaging or ultrasound.

28. The method of claim 24, 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.

29. The method of claim 24, 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, locations of one or more vascular structures, or locations of one or more neurological structures.

30. The method of claim 24, 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.

31. The method of claim 24, further comprising implanting 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.

32. The method of claim 24, wherein the implantable medical device includes an implantable neurostimulator.

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

34. The method of claim 33, further comprising providing an implantable medical device as a function of the skull contour data.

35. The method of claim 33, 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.

36. The method of claim 33, further comprising implanting the implantable medical device at the selected implantation site.

37. The method of claim 33, wherein the implantable medical device includes an implantable neurostimulator.

38. A method comprising:

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.

39. The method of claim 38, wherein identifying the physiological structures comprises identifying at least one of a vascular structure or a neurological structure.

40. The method of claim 38, further comprising selecting a site 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, the implantable medical device configured to be implanted between a scalp and a skull of the patient.

41. The method of claim 38, further comprising making an incision at the selected incision site.

42. A method comprising:

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;

receiving an implantation criterion; and

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

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

43. The method of claim 42, 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.

44. The method of claim 42, 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.

45. The method of claim 42, wherein the implantable medical device includes an implantable neurostimulator.

46. A method comprising:

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;

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

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

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

47. The method of claim 46, further comprising disclosing to a user whether the implantation site satisfies an implantation criterion.

48. The method of claim 46, further comprising disclosing to a user information about adjusting a standard configuration of the implantable medical device as a function of the image and the implantation site.

49. The method of claim 48, 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.

50. The method of claim 46, 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.

51. The method of claim 46, wherein the implantable medical device includes an implantable neurostimulator.

52. A computer-readable medium comprising instructions for causing a programmable processor to:

receive 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;

receive an implantation criterion; and

propose at least one implantation site for an implantable medical device as a function of the image and the implantation criterion,

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

53. The medium of claim 52, the instructions further causing the processor to:

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

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

54. The medium of claim 52, 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.

55. The medium of claim 52, wherein the implantable medical device includes an implantable neurostimulator.

56. A computer-readable medium comprising instructions for causing a programmable processor to:

receive 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;

receive an implantation site for an implantable medical device; and

disclose to a user information about at least one feature of the head at the implantation site,

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

57. The medium of claim 56, instructions further causing the processor to disclose to a user whether the implantation site satisfies an implantation criterion.

58. The medium of claim 56, instructions further causing the processor to disclose to a user information about adjusting a standard configuration of the implantable medical device as a function of the image and the implantation site.

59. The medium of claim 58, 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.

60. The medium of claim 56, 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.

61. The medium of claim 56, wherein the implantable medical device includes an implantable neurostimulator.

62. 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 comprising at least one module that includes control electronics within a housing and a member that at least partially encapsulates the housing.

63. The method of claim 62, further comprising determining whether the patient is a candidate for implantation of the implantable medical device deployed in a recess created in a skull of the patient.

64. The method of claim 62, further comprising implanting 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.

65. The method of claim 62, 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, locations of one or more vascular structures, or locations of one or more neurological structures.

66. The method of claim 62, 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.

67. The method of claim 62, wherein the implantable medical device includes an implantable neurostimulator.