IMPLANTATION OF IMPLANTABLE MEDICAL DEVICE

• US 20090299164A1
• 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:
  US12/538,617
• Publication Number:
  US 20090299164A1
• 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;

identifying physiological structure in the image, wherein the physiological structure includes one or more of skull curvature, skull thickness, scalp thickness, locations of one or more vascular structures within a scalp of the patient, or locations of one or more nerves within the scalp;

evaluating a configuration of an implantable medical device based on the physiological structure to determine whether the configuration of the implantable medical device is suitable for implantation under a scalp of the patient, the implantable medical device including a housing encasing control electronics; and

indicating the configuration of the medical device is suitable for implantation of the medical device in the event the evaluation determines the configuration to be suitable for implantation of the medical device.

2. The method of claim 1, further comprising selecting the configuration from a plurality of configurations based on the identified physiological structure.

3. The method of claim 1, further comprising receiving an indication of the configuration.

4. The method of claim 1, further comprising selecting the configuration from a plurality of configurations based on the identified physiological structure and a selected implantation site for the medical device under the scalp of the patient.

5. The method of claim 4, 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.

6. The method of claim 1, wherein evaluating whether the configuration is suitable for implantation of the medical device 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.

7. The method of claim 1, further comprising implanting at least the housing of the medical device under the scalp of the patient in the event the evaluation determines the configuration to be suitable for implantation of the medical device.

8. The method of claim 1, wherein the image comprises skull contour data.

9. 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 configuration of the implantable medical device 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, and

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

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

12. 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 configuration is suitable for implantation of the medical device includes evaluating, as a function of the image of the scalp, whether the configuration is suitable for implantation of the medical device.

13. The method of claim 1, further comprising:

receiving an implantation criterion; and

disclosing to a user whether the configuration satisfies the implantation criterion.

14. The method of claim 13, wherein the implantation criterion is based on one or more 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.

15. The method of claim 1, further comprising:

selecting an incision site as a function of the physiological structures; and

indicating the selected incision site to the user.

16. The method of claim 15, wherein the image of the head includes an image of the scalp of the patient, wherein a least a portion of the physiological structure used to select the incision site is included in the image of the scalp of the patient.

17. The method of claim 1, further comprising tailoring the medical device to conform to the indicated configuration.

18. The method of claim 17, wherein the tailoring comprises one of flexing, bending, selecting a plurality of modules, and trimming the medical device.

19. The method of claim 1, wherein the physiological structure includes skull curvature.

20. The method of claim 1, wherein the physiological structure includes skull thickness.

21. The method of claim 1, wherein the physiological structure includes scalp thickness.

22. The method of claim 1, wherein the physiological structure includes locations of one or more vascular structures within the scalp.

23. The method of claim 1, wherein the physiological structure includes locations of one or more nerves within the scalp.

24. 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, fluoroscopy, or ultrasound imaging.

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

26. A method comprising:

receiving an image of a head of a patient;

identifying physiological structure in the image, wherein the physiological structure includes one or more of skull curvature, skull thickness, scalp thickness, locations of one or more vascular structures within a scalp of the patient, or locations of one or more nerves within the scalp;

evaluating a configuration of an implantable medical device based on the physiological structure to determine whether the configuration of the implantable medical device is suitable for implantation under a scalp of the patient, the implantable medical device including a housing encasing control electronics; and

indicating the configuration is not suitable for implantation of the medical device in the event the evaluation determines the configuration is unsuitable for implantation of the medical device.

27. 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 a configuration of an implantable medical device satisfies an implantation criterion for implantation of the implantable medical device under a scalp of the patient, the implantable medical device including a housing encasing control electronics; and

disclose to a user whether the configuration of the implantable medical device satisfies the implantation criterion;

wherein the instructions to evaluate, as a function of the image, whether the configuration satisfies the implantation criterion 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, or locations of one or more nerves within the scalp, and evaluate whether the configuration satisfies the implantation criterion 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.

28. The medium of claim 27, wherein receiving the image comprises receiving an image generated by at least one of X-ray, magnetic resonance imaging, CT-scan, or fluoroscopy.

29. The medium of claim 27, 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.

30. The medium of claim 27, 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.

31. The medium of claim 27, wherein the image of the head of the patient includes an image of a scalp of the patient.

32. The medium of claim 27, the instructions further causing the processor to:

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

propose, as a function of the skull contour data, the configuration for the implantable medical device; and

disclose the proposed configuration to the user.

33. The medium of claim 27, the instructions further causing the processor to:

receive the implantation criterion; and

propose at least the configuration for the implantable medical device based on the implantation criterion and 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.

34. The medium of claim 33, the instructions further causing the processor to propose a second configuration for the implantable medical device based on the implantation criterion and 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.

35. The medium of claim 33, wherein the implantation criterion is based on 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.

36. The medium of claim 27, the instructions further causing the processor to receive an indication of the configuration from the user.

37. The medium of claim 27, 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.

38. The medium of claim 27, wherein the instructions to evaluate, as a function of the image, whether the configuration satisfies the implantation criterion include instructions to identify, based on the image, the skull curvature and evaluate whether the configuration satisfies the implantation criterion based on the skull curvature.

39. The medium of claim 27, wherein the instructions to evaluate, as a function of the image, whether the configuration satisfies the implantation criterion include instructions to identify, based on the image, the skull thickness and evaluate whether the configuration satisfies the implantation criterion based on the skull thickness.

40. The medium of claim 27, wherein the instructions to evaluate, as a function of the image, whether the configuration satisfies the implantation criterion include instructions to identify, based on the image, the scalp thickness and evaluate whether the configuration satisfies the implantation criterion based on the scalp thickness.

41. The medium of claim 27, wherein the instructions to evaluate, as a function of the image, whether the configuration 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 configuration satisfies the implantation criterion based on the locations of one or more vascular structures within the scalp.

42. The medium of claim 27, wherein the instructions to evaluate, as a function of the image, whether the configuration 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 configuration satisfies the implantation criterion based on the locations of one or more nerves within the scalp.