IMPLANTATION OF IMPLANTABLE MEDICAL DEVICE

• US 20090299165A1
• Filed: 08/10/2009
• Published: 12/03/2009
• Est. Priority Date: 04/29/2004
• Status: Abandoned Application

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Singhal, Ruchika, Skime, Robert M., Wahlstrand, Carl D., Urquhart, Steven J.
• Application Number:
  US12/538,623
• Publication Number:
  US 20090299165A1
• Time in Patent Office: Days
• US Class Current: 600/377
• 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;

evaluating, as a function of the image, whether the patient is a candidate for implantation of an implantable medical device, the implantable medical device including a housing encasing control electronics, under a scalp of the patient; and

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

wherein evaluating, 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 evaluating whether the patient is a candidate for implantation based on the one or more of the skull contour, 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 evaluating, as a function of the image, 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, wherein the implantable medical device comprises a member that at least partially encapsulates the housing.

5. The method of claim 1, wherein evaluating, 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, and

wherein providing the implantable medical device comprises adjusting a standard configuration of the implantable medical device to fit the physical model of the skull.

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

10. 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.

11. The method of claim 10, 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.

12. The method of claim 10, wherein selecting one of the configurations includes selecting the configuration as a function of one or more of skull contour, skull thickness, scalp thickness, locations of one or more vascular structures, or locations of one or more neurological structures indicated by the image.

13. The method of claim 1,

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

and

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

14. The method of claim 1, further comprising conditioning the scalp of the patient to receive the implantable medical device beneath the scalp.

15. The method of claim 14, 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.

16. The method of claim 1,

further comprising evaluating 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.

17. The method of claim 16, 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 and skull thickness.

18. The method of claim 16, wherein implanting at least the housing of the implantable medical device under the scalp of the patient comprises implanting at least the housing of the implantable medical device at the selected implantation site.

19. 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 soft-tissue image; and

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

20. The method of claim 19, wherein identifying the physiological structures comprises identifying at least one of a vascular structure and a neurological structure.

21. The method of claim 1, the method further comprising:

receiving an implantation criterion; and

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

22. The method of claim 21, 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.

23. The method of claim 21, wherein the implantation criterion comprises one or more attributes of skull curvature, skull thickness, scalp thickness, locations of one or more vascular structures in the scalp of the patient, locations of one or more neurological structures in the scalp of the patient, or potential incision locations.

24. 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 indication of an implantation site for implantation of implantable medical device under the scalp of the patient; and

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

25. The method of claim 24, further comprising disclosing to the user whether the implantation site satisfies an implantation criterion.

26. The method of claim 1, wherein evaluating, as a function of the image, whether the patient is a candidate for implantation includes identifying, based on the image, the skull curvature and evaluating whether the patient is a candidate for implantation based on the skull curvature.

27. The method of claim 1, wherein evaluating, as a function of the image, whether the patient is a candidate for implantation includes identifying, based on the image, the skull thickness and evaluating whether the patient is a candidate for implantation based on the skull thickness.

28. The method of claim 1, wherein evaluating, as a function of the image, whether the patient is a candidate for implantation includes identifying, based on the image, the scalp thickness and evaluating whether the patient is a candidate for implantation based on the scalp thickness.

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

30. The method of claim 1, wherein evaluating, as a function of the image, whether the patient is a candidate for implantation includes identifying, based on the image, the locations of one or more nerves within the scalp and evaluating whether the patient is a candidate for implantation based on the locations of one or more nerves within the scalp.

31. A method comprising:

receiving an image of a head of a patient; and

evaluating, as a function of the image, whether the patient is a candidate for implantation of an implantable medical device, the implantable medical device including a housing encasing control electronics, under the scalp of the patient,

wherein evaluating, 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, and scalp thickness, and evaluating whether the patient is a candidate for implantation based on the one or more of the skull curvature, skull thickness, and scalp thickness;

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

planning an implantation at another site within the patient.

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

receive an image of a head of a patient;

evaluate, as a function of the image, whether the patient is a candidate for implantation of an implantable medical device, the implantable medical device including a housing encasing control electronics, under a scalp of the patient; and

disclose to a user whether the patient is a candidate for implantation of an implantable medical device based on the evaluation,

wherein the instructions to evaluate, as a function of the image, whether the patient is a candidate for implantation include instructions to identify, based on the image, one or more of skull curvature, skull thickness, scalp thickness, locations of one or more vascular structures within the scalp, and locations of one or more nerves within the scalp, and instructions to evaluate whether the patient is a candidate for implantation based on the one or more of the skull contour, skull thickness, scalp thickness, locations of one or more vascular structures within the scalp, or locations of one or more nerves within the scalp.

33. The medium of claim 32, wherein receiving the image comprises receiving an image generated by at least one of X-ray, magnetic resonance imaging, CT-scan or fluoroscopy.

34. The medium of claim 32, the instructions further causing the processor to evaluate, as a function of the image, whether the patient is a candidate for implantation of the implantable medical device deployed in a recess created in the skull.

35. The medium of claim 32, the instructions further causing the processor to evaluate, 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.

36. The medium of claim 32, the instructions further causing the processor to select, 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.

37. The medium of claim 36, 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.

38. The medium of claim 36, wherein selecting one of the configurations includes selecting the configuration as a function of one or more of skull contour, skull thickness, scalp thickness, locations of one or more vascular structures, and locations of one or more neurological structures indicated by the image.

39. The medium of claim 32, wherein the image of the head of the patient includes an image of a scalp of the patient.

40. The medium of claim 32, the instructions further causing the processor to:

evaluate skull contour data based on the image of the head; and

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

41. The medium of claim 32, the instructions further causing the processor to:

receive implantation criterion; and

propose at least one implantation site for the implantable medical device based on the implantation criterion and the one or more of skull contour, skull thickness, scalp thickness, locations of one or more vascular structures within the scalp, and locations of one or more nerves within the scalp.

42. The medium of claim 41, the instructions further causing the processor to propose a second implantation site for the implantable medical device based on the implantation criterion and the one or more of skull contour, skull thickness, scalp thickness, locations of one or more vascular structures within the scalp, and locations of one or more nerves within the scalp.

43. The medium of claim 41, wherein the implantation criterion comprises one or more attributes 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.

44. The medium of claim 32, the instructions further causing the processor to receive an indication of the implantation site from the user.

45. The medium of claim 32, wherein the image of the head of the patient includes a soft-tissue image and a hard-tissue image of the head of the patient.

46. The medium of claim 32, wherein the instructions to evaluate, as a function of the image, whether the implantation site satisfies the implantation criterion include instructions to identify, based on the image, the skull curvature and evaluate whether the implantation site satisfies the implantation criterion based on the skull curvature.

47. The medium of claim 32, wherein the instructions to evaluate, as a function of the image, whether the implantation site satisfies the implantation criterion include instructions to identify, based on the image, the skull thickness and evaluate whether the implantation site satisfies the implantation criterion based on the skull thickness.

48. The medium of claim 32, wherein the instructions to evaluate, as a function of the image, whether the implantation site satisfies the implantation criterion include instructions to identify, based on the image, the scalp thickness and evaluate whether the implantation site satisfies the implantation criterion based on the scalp thickness.

49. The medium of claim 32, wherein the instructions to evaluate, as a function of the image, whether the implantation site satisfies the implantation criterion include instructions to identify, based on the image, the locations of one or more vascular structures within the scalp and evaluate whether the implantation site satisfies the implantation criterion based on the locations of one or more vascular structures within the scalp.

50. The medium of claim 32, wherein the instructions to evaluate, as a function of the image, whether the implantation site satisfies the implantation criterion include instructions to identify, based on the image, the locations of one or more nerves within the scalp and evaluate whether the implantation site satisfies the implantation criterion based on the locations of one or more nerves within the scalp.