Simulation method for designing customized medical devices

• US 20020137014A1
• Filed: 03/05/2002
• Published: 09/26/2002
• Est. Priority Date: 03/06/2001
• Status: Active Grant

• Current Assignee: Agency For Science Technology and Research, Johns Hopkins University
• Original Assignee: Agency For Science Technology and Research
• Inventors: Wang, Yaoping, Nowinski, Wieslaw L., Brody, William R., Chui, Chee-Kong, Cai, Yiyu, Anderson, James H.
• Granted Patent: US 7,371,067 B2
• Time in Patent Office: Days
• US Class Current: 434/262
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2002/067 modular
• CPC Class Codes: G09B 23/285 for injections, endoscopy, bronchoscopy, sigmoidscopy, insertion of contraceptive devices or enemas
• CPC Class Codes: G16H 50/50 for simulation or modelling of medical disorders
• CPC Class Codes: Y10S 623/901 Method of manufacturing prosthetic device

Abstract

The invention provides a system for virtually designing a medical device conformed for use with a specific patient. Using the system, a three-dimensional geometric model of a patient-specific body cavity or lumen is reconstructed from scanned volume images such as obtained x-rays, magnetic resonance imaging (MRI), computer tomography (CT), ultrasound (US), angiography or other imaging modalities. Knowledge of the physical properties of the cavity/lumen is obtained by determining the relationship between image density and the stiffness or elasticity of tissues in the body cavity or lumen and is used to model interactions between a simulated device and a simulated body cavity or lumen.

Claims

1. A method for designing a medical device for accessing a body cavity or lumen of a patient comprising:

(a) providing data relating to a three-dimensional geometric model of the cavity or lumen to a system comprising a knowledge base;

(b) obtaining a recommendation from the system relating to the geometry of a device for placement into the cavity or lumen.

2. The method according to claim 1, wherein the knowledge base is a device shape knowledge base comprising a plurality of geometries for at least one segment of a device and rules for determining correspondence between a geometry of at least one segment and at least a portion of the model of the body cavity or lumen.

3. The method according to claim 1, wherein the three-dimensional geometric model of the cavity or lumen is obtained from a volume image of the cavity or lumen.

4. The method according to claim 3, wherein the volume image is obtained from one or more of:

an X-ray, Magnetic Resonance Imaging, Computer Tomography, rotational angiography, gadolinium enhanced MRA, and ultrasound.

5. The method according to claim 1, wherein the knowledge base comprises data relating to a physical property of the cavity or lumen.

6. The method according to claim 5, wherein the physical property is the elasticity of the cavity or lumen.

7. The method according to claim 1, wherein the recommendation is displayed on an interface of a user device connectable to the network.

8. The method according to claim 7, wherein the recommendation is in the form of a three-dimensional representation of the device.

9. The method according to claim 7, wherein selectable options corresponding to design parameters of the device are transmitted to, and displayed on, the interface of the user device.

10. The method according to claim 9, wherein the selectable options are selected from the group consisting of:

shape, material, flexibility, shape memory, stiffness, softness, pliability, stability, strength, contrast medium flow rate, length, size, and combinations thereof.

11. The method according to claim 9, wherein one or more of the selectable options are selected and the system simulates the design of the device based on the one or more selected options.

12. The method according to claim 1, wherein the device is selected from the group consisting of a catheter, a guidewire, a balloon, a balloon-inflating device, a coil, a stent, stent-graft, an endoscope, a laparoscope, a bronchoscope, a surgical device, a vascular occlusion device, an optical probe, and a drug delivery device.

13. The method according to claim 1 or 12, wherein the design of more than one device is simulated.

14. The method according to claim 13, wherein parameters selected for one of the devices is based on parameters of at least one of the other devices.

15. The method according to claim 1, wherein the medical device is designed to access a lumen which is a blood vessel.

16. The method according to claim 1, wherein the recommendation relates to the geometry of the device.

17. The method according to claim 16, wherein the device comprises multiple segments and parameters of one or more of the multiple segments are selected independently.

18. The method according to claim 17, wherein the device is selected from the group consisting of a catheter, a guidewire, a balloon, a balloon-inflating device, a coil, a stent, stent-graft, an endoscope, a laparoscope, a bronchoscope, a surgical device, a vascular occlusion device, an optical probe, and a drug delivery device

19. The method according to claim 18, wherein at least one segment is selected from the group consisting of a tip, a rod element, a hook element and a hub.

20. The method according to claim 17, wherein at least two segments have varying material properties.

21. The method according to claim 1, wherein the system simulates a path representing at least a portion of the body cavity or lumen and determines best fit between the geometry of the device and the geometry of the path.

22. The method according to claim 1, wherein the method further comprises performing one or more feature operations to modify the recommended geometry.

23. The method according to claim 22, wherein the one or more feature operations are selected from the group consisting of shape sweeping, extruding, holing, braiding, edge rounding, and hub construction.

24. The method according to claim 1, further comprising performing a goal-driven search of the knowledge base to identify a device geometry which optimally corresponds to the model of the cavity or lumen.

25. The method according to claim 1, wherein the knowledge base includes clinical information relating to the patient.

26. The method according to claim 1, wherein the device geometry is determined using Finite Element Analysis.

27. The method according to claim 7, wherein in response to a query, the system displays a rule used for making the recommendation.

28. The method according to claim 1, wherein the patient has a pathology affecting the structure of the body cavity or lumen.

30. The system according to claim 29, further comprising a processor for receiving data relating to a three-dimensional geometric model of the cavity or lumen.

31. The system according to claim 29, wherein the data is obtained from a plurality of scanned images of the cavity or lumen.

32. The system according to claim 31, wherein the system is in communication with a scanning device for obtaining the scanned images.

33. The system according to claim 29, wherein the system further comprises a user device comprising an interface for interfacing with a user which is connectable to the knowledge base and the network.

34. The system according to claim 33, wherein the interface displays options for selecting one or more device parameters

35. The system according to claim 33, wherein the interface comprises fields for inputting clinical data relating to the patient.

36. The system according to claim 33, wherein the knowledge base transmits data relating to the one or more device segment geometries to the user interface upon receiving data relating to the geometry of the cavity or lumen.

37. The system according to claim 36, wherein the data relating to the one or more device segment geometries is in the form of a graphical representation of the one or more device segments.

38. The system according to claim 29, further comprising a device materials knowledge base comprising a plurality of data files relating to device materials and rules for determining suitability of a device material for at least one segment of the device.

39. The system according to claim 38, wherein the device materials knowledge base further comprises information relating to the elasticity of the portion of the body cavity or lumen.

40. The system according to claim 33, wherein selectable options corresponding to design parameters of the device are transmitted to, and displayed on, the interface of the user device based on the data relating to the geometry of at least a portion of the cavity or lumen.

41. The system according to claim 40, wherein the selectable options are selected from one or more of the group consisting of:

shape, material, flexibility, shape memory, stiffness, softness, pliability, stability, strength, contrast medium maximum flow rate, length, size.

42. The system according to claim 40, wherein when one or more of the selectable options are selected, the system simulates the design of the device based on the selected options.

43. The system according to claim 38, wherein the system simulates a path representing at least a portion of the body cavity or lumen and determines best fit between the geometry of the device and the geometry of the path.

44. The system according to claim 33, wherein one or more feature operations are displayed on the interface and wherein selecting a feature operation modifies the shape of at least a segment of the device.

45. The system according to claim 44, wherein the one or more feature operations are selected from the group consisting of shape sweeping, extruding, holing, braiding, edge rounding, and hub construction.

46. The system according to claim 29, further comprising an expert system for identifying relationships between data in the knowledge base and data relating to the images.

47. The system according to claim 29, further comprising a data file comprising clinical information relating to the patient.

48. The system according to claim 29, further comprising a Finite Element Analysis engine.

50. The software suite of claim 49, further comprising a second component for interfacing with a user device;

wherein the second component provides a retrieval function for retrieving data relating to a geometric model of at least a portion of the body cavity or lumen and a transmitting function for transmitting the data to the knowledge base.

29. A system for designing a medical device for accessing a body cavity or lumen of a patient, comprising:

a device shape knowledge base comprising;

a plurality of geometries for at least one segment of a device; and

rules for determining correspondence between a geometry of at least one segment and at least a portion of a model of the body cavity or lumen.

49. A software suite for design of a medical device for accessing a body cavity or lumen comprising:

a first component for storing a device shape knowledge base, the knowledge base comprising a plurality of geometries for at least one segment of the device and rules for determining correspondence between the geometry of the at least one segment and at least a portion of a geometric model of the body cavity or lumen; and

a second component comprising an executing function for executing one or more programs for determining whether one or more of the geometries of the at least one segment corresponds to the geometric model of at least a portion of the body cavity or lumen based on the rules for determining correspondence.