Mass production of individualized medical devices

Patent metadata

Field	Value
Publication number	US-9802281-B2
Application number	US-201414339663-A
Country	US
Kind code	B2
Filing date	Jul 24, 2014
Priority date	Dec 2, 2008
Publication date	Oct 31, 2017
Grant date	Oct 31, 2017

Abstract

A plurality of individual medical devices is created that define a medical device family. Within the family of medical devices, each of the plurality of medical devices has at least one dimension that, within an acceptable tolerance, is substantially equal to the same dimension of another of the plurality of medical devices. Thus, for each medical device in the family, another, corresponding medical device has at least one substantially similar dimension. For example, a first medical device may have a first value for a dimension and a second medical device may have a second value for the same dimension that is equal to one of the sum of the second dimension and the acceptable tolerance or the difference between the second dimension and the acceptable tolerance. Thus, each of the plurality of medical devices varies from another of the plurality of medical devices by the acceptable tolerance.

First claim

What is claimed is:

1. A method of manufacturing a plurality of medical devices configured to replicate a portion of the anatomy of patients within an identified patient population in at least a first dimension, wherein the method includes manufacturing a plurality of medical devices that includes at least a first medical device, a second medical device, and a third medical device, the first medical device having a first value for the first dimension that is substantially equal to an established minimum value for the first dimension, the second medical device having a second value for the first dimension that is both greater than the first value and substantially equal to or less than the sum of the first value and an acceptable tolerance within the identified patient population for the first dimension, and the third medical device having a third value for the first dimension that is substantially equal to an established maximum value for the first dimension, wherein the established minimum value for the first dimension corresponds to a patient within the identified patient population having a low value for the first dimension, and wherein the established maximum value for the first dimension corresponds to a patient within the identified patient population having a high value for the first dimension.

2. The method of claim 1 , wherein the plurality of medical devices includes a fourth medical device having a fourth value for the first dimension, and wherein the fourth value is both less than the third value and substantially equal to or greater than the third value minus the acceptable tolerance.

3. The method of claim 2 , wherein the difference between the first value and the second value is substantially equal to the difference between the third value and the fourth value.

4. The method of claim 2 , wherein the second value is less than the sum of the first value and the acceptable tolerance, and wherein the fourth value is greater than the third value minus the acceptable tolerance.

5. The method of claim 1 , wherein the plurality of medical devices includes a fifth medical device having a fifth value for the first dimension, and wherein the fifth value is both greater than the second value and substantially equal to or less than the sum of the second value and the acceptable tolerance.

6. The method of claim 1 , wherein the plurality of medical devices is a plurality of distal femoral implants.

7. The method of claim 6 , wherein the first dimension is one of a medical/lateral femoral width and an anterior/posterior femoral length.

8. The method of claim 1 , wherein the second value is less than the sum of the first value and the acceptable tolerance.

9. The method of claim 1 , wherein a majority of the patients within the identified patient population have a value for the first dimension that is between the high value and the low value.

10. The method of claim 1 , wherein the maximum value corresponds to the patient within the identified patient population having the highest value for the first dimension and the minimum value corresponds to the patient within the identified patient population having the lowest value for the first dimension.

11. A method of manufacturing a plurality of medical devices configured to replicate a portion of the anatomy of patients within an identified patient population in at least a first dimension, the method comprising:
manufacturing a first medical device having a first value for the first dimension that is equal to an established minimum value for the first dimension;
manufacturing a second medical device having a second value for the first dimension that is equal to an established maximum value for the first dimension; and
manufacturing a plurality of intermediate medical devices, each of the plurality of intermediate medical devices having a value for the first dimension that is greater than one of the first value of the first medical device and the value of another of the plurality of intermediate medical devices by no more than an acceptable tolerance within the identified patient population for the first dimension and that is less than one of the second value of the second medical device and the value of another of the plurality of intermediate medical devices by no more than the acceptable tolerance.

12. The method of claim 11 , wherein the acceptable tolerance incorporates an acceptable patient fit tolerance.

13. The method of claim 11 , wherein each of the plurality of intermediate medical devices has a value for the first dimension that is greater than one of the first value of the first medical device and the value of another of the plurality of intermediate medical devices by less than the acceptable tolerance and that is less than one of the second value of the second medical device and the value of another of the plurality of intermediate medical devices by less than the acceptable tolerance.

14. The method of claim 11 , wherein the plurality of intermediate medical devices comprises a third medical device having a third value for the first dimension and a fourth medical device having a fourth value for the first dimension that is greater than the third value, the difference between the first value and the third value and the difference between the second value and the fourth value being less than or equal to the acceptable tolerance.

15. The method of claim 14 , wherein the difference between the first value and the third value and the difference between the second value and the fourth value is less than the acceptable tolerance.

16. The method of claim 14 , wherein the difference between the first value and the third value is substantially equal to the difference between the second value and the fourth value.

17. The method of claim 16 , wherein the plurality of intermediate medical devices comprises a fifth medical device having a fifth value for the first dimension, and wherein the difference between the fifth value and one of the third value and the fourth value is substantially equal to the differences between the first value and the third value and the second value and the fourth value.

18. The method of claim 11 , wherein the plurality of medical devices is a plurality of distal femoral implants.

19. The method of claim 18 , wherein the first dimension is one of a medial/lateral femoral width and an anterior/posterior femoral length.

20. The method of claim 11 , wherein a majority of the patients within the identified patient population have a value for the first dimension that is between the high value and the low value.

21. The method of claim 11 , wherein the maximum value corresponds to the patient within the identified patient population having the highest value for the first dimension and the minimum value corresponds to the patient within the identified patient population having the lowest value for the first dimension.

Assignees

• Zimmer Inc

Inventors

• Sanford Adam H
• Acker Dean M
• Brown Jeffrey D
• Earl Brian D
• Pendleton John E

Classifications

• A61F2/4657

  Measuring instruments used for implanting artificial joints (for surgical instruments A61B90/06) · CPC title

• A61F2002/30616

  Sets comprising a plurality of prosthetic parts of different sizes or orientations · CPC title

• A61F2/30

  Joints · CPC title

• Y10T29/49

  Method of mechanical manufacture · CPC title

• A61F2/3094

  Designing or manufacturing processes · CPC title