Method of cutting material for use in implantable medical device

• US 7,594,974 B2
• Filed: 12/08/2004
• Issued: 09/29/2009
• Est. Priority Date: 07/26/2001
• Status: Expired

• Current Assignee: 3F Therapeutics Incorporated (Medtronic Plc)
• Original Assignee: 3F Therapeutics Incorporated (Medtronic Plc)
• Inventors: Myers, Keith E., Cali, Douglas S.
• Primary Examiner(s): SELLS, JAMES D
• Application Number:
  US11/007,732
• Publication Number:
  US 20050098547A1
• Time in Patent Office: 1,756 Days
• Field of Search: 156/64, 156/250, 156/251, 623/2.1, 623 212- 219, 623/901, 623/909, 623/910, 372/25, 372/29.02, 372/30, 372/55
• US Class Current: 156/64
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: B23K 2103/16 Composite materials , e.g. fibre reinforced
• CPC Class Codes: B23K 2103/30 Organic material
• CPC Class Codes: B23K 2103/38 Fabrics, fibrous materials
• CPC Class Codes: B23K 2103/42 Plastics B23K2103/16 takes precedence
• CPC Class Codes: B23K 2103/50 Inorganic material, e.g. metals, not provided for in B23K2103/02 – B23K2103/26
• CPC Class Codes: B23K 26/32 taking account of the properties of the material involved
• CPC Class Codes: B23K 26/324 involving non-metallic parts
• CPC Class Codes: B23K 26/40 taking account of the properties of the material involved
• CPC Class Codes: Y10T 156/1054 and simultaneously bonding [e.g., cut-seaming]

Abstract

A method of cutting material for use in an implantable medical device employs a plotted laser cutting system. The laser cutting system is computer controlled and includes a laser combined with a motion system. The laser precisely cuts segments out of source material according to a predetermined pattern as designated by the computer. The segments are used in constructing implantable medical devices. The cutting energy of the laser is selected so that the cut edges of the segments are melted to discourage delamination or fraying, but communication of thermal energy into the segment beyond the edge is minimized to avoid damaging the segment adjacent the edge.

Claims

1. A method of creating an implantable medical prosthesis, comprising:

a. providing a sheet of pericardium, wherein the pericardium has at least two tissue layers;

b. supporting the sheet of pericardium with a support platform;

c. providing a laser cutting apparatus having a laser tube assembly configured to create a laser beam which is directed through a series of optical elements to direct a laser beam on the support platform; and

d. cutting a segment of tissue out of the sheet of pericardium with a laser beam;

said cutting comprising operating the laser apparatus at a power and pulse rate such that said laser beam welds the layers of the pericardium together along a laser cut edge

wherein sufficient energy is imparted to vaporize portions of the pericardium along the cut edge and to at least partially melt the cut edges without substantial burning of the pericardium adjacent the cut edge and further wherein the cut edge of the tissue segment is not susceptible to premature wear.

2. The method of claim 1, wherein the pericardium tissue comprises equine pericardium.

3. The method of claim 1, wherein the laser beam power and pulse rate are selected so that there is substantially no discoloration of the pericardium along the cut edge.

4. The method of claim 1, wherein the prosthesis comprises a heart valve, said cutting comprising cutting a plurality of segments of tissue out of the sheet of pericardium with the laser beam and attaching the cut segments to one another to form the valve.

6. The method of creating an implantable medical prosthesis of claim 1 further comprising providing a motion system to selectively locate and move the position of the laser beam relative to the pericardium tissue.

7. The method of claim 6 further comprising providing an electronic mechanism that changes the relative position of the support platform and the beam.

8. The method of claim 7 wherein the motion system actuates the electronic mechanism to adjust the relative position of the laser beam.

9. The method of claim 7 wherein the electronic mechanism is connected to the laser beam to move the laser beam relative to the support platform.

10. The method of claim 6 wherein the motion system comprises a digital processor connected to the electronic mechanism for selecting cutting patterns.

11. The method of claim 10 wherein the digital processor further comprises a computer assisted design software program.

12. The method of claim 11 wherein the computer assisted design software program further comprises a template.

13. The method of claim 1 wherein the optical components further comprises lenses.

14. The method of claim 1 wherein the optical components further comprises mirrors.

15. The method of claim 1 further comprising operating the laser in a pulsed manner and supplying from about 0.005 of laser energy per pulse to about 0.5 joules of laser energy per pulse.

16. The method of claim 15 further comprising operating the laser to produce a laser spot size of from about 0.002 inches in diameter to about 0.005 inches in diameter.

17. The method of claim 1 further comprising operating the laser at a cutting speed of about 1 inch per second.

18. The method of claim 15 wherein operating the laser in a pulsed manner comprises supplying a pulse rate of about 1000 pulses per inch.

19. The method of claim 1 further comprising operating the laser at a wavelength of about 10.6 microns.

20. The method of claim 1 further comprising operating the laser at a wavelength of from about 2.7 microns to about 3.0 microns.

21. The method of claim 3 wherein the laser energy selected is about 0.0075 joules per pulse and a laser spot diameter of about 0.003 inches.

5. A method of creating an implantable medical prosthesis, comprising:

providing a sheet of pericardium, wherein the pericardium has at least two tissue layers; and

cutting a segment of tissue out of the sheet of pericardium with a laser beam;

said cutting comprising operating a laser at a power and pulse rate having the following parameters;

1.5 lens, 20 percent power setting, 3.4 percent speed, 1,000 pulses per inch and 1,000 dots per inch, such that said beam welds the layers of the pericardium together along a laser cut edge without significantly burning the pericardium adjacent the cut edge.