Laser perforator

• US 5,643,252 A
• Filed: 09/24/1993
• Issued: 07/01/1997
• Est. Priority Date: 10/28/1992
• Status: Expired due to Fees

• Current Assignee: Transmedica International Incorporated
• Original Assignee: Venisect, Inc.
• Inventors: Flock, Stephen T., Waner, Milton, Vestal, Charles H.
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US08/126,241
• Time in Patent Office: 1,376 Days
• Field of Search: 606/2-7, 606/9-19, 606/27-29, 607/88, 607/89, 604/21, 604/22, 128/770
• US Class Current: 606/9
• CPC Class Codes: A61B 17/3476 Powered trocars, e.g. electrosurgical cutting, lasers, powered knives
• CPC Class Codes: A61B 18/20 using laser
• CPC Class Codes: A61B 2017/00765 Decreasing the barrier function of skin tissue by radiated energy, e.g. using ultrasound, using laser for skin perforation
• CPC Class Codes: A61B 2218/008 for smoke evacuation
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150076 by heating
• CPC Class Codes: A61B 5/150343 Collection vessels for collecting blood samples from the skin surface, e.g. test tubes, cuvettes sampling from within body cavities A61B5/150015, A61B5/150045
• CPC Class Codes: A61B 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/15138 provided with means to ensure the protection of the user, e.g. to avoid laser light entering the eyes of a user
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: A61B 5/7217 of noise originating from a therapeutic or surgical apparatus, e.g. from a pacemaker
• CPC Class Codes: A61M 37/00 Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04

Abstract

This invention provides a device and method for perforation of skin for the purpose of drawing blood or administering pharmaceuticals. The device incorporates a laser which produces a laser beam at an appropriate wavelength which is specifically focused to perforate the skin of a patient. Optionally a container can be incorporated in the device for collecion of blood from the perforated tissue.

Claims

1. A laser perforator device for perforating skin comprising

a) a lasing element which emits a pulsed beam;

b) a power source;

c) a high voltage pulse-forming network linked to the power source;

d) a means for exciting the lasing element, linked to the pulse-forming network;

e) a laser cavity; and

f) a focusing means which focuses the beam from said lasing element to at least one beam shaped as an ellipse at the focal point of the beam.

2. The device of claim 1 wherein the lasing element emits a wavelength that is strongly absorbed by tissue.

3. The device of claim 1 wherein the lasing element is selected from the group consisting of Er:

YAG, pulsed CO₂, Ho;

YAG, Er;

YAP, Er/Cr;

YSGG, Ho;

YSGG, Er;

GGSG, Er;

YLF, Tm;

YAG, Ho/Nd;

YAlO₃, cobalt;

MgF₂, HF chemical, DF chemical, carbon monoxide, deep UV lasers, diode lasers, and frequency tripled Nd;

YAG.

4. The device of claim 1 wherein the laser wavelength is between 2 and 7 microns.

5. The device of claim 4 wherein the lasing element is an Er:

YAG laser rod.

6. The device of claim 1 wherein the focusing means focuses the beam from said lasing element at a distance at least 10 mm from the lasing element.

7. The device of claim 1 further comprising an applicator positioned along the path of the beam between the laser cavity and the tissue to be perforated so that the focal point of the beam is within or at one end of the applicator.

8. The device of claim 7 wherein the applicator includes a beam dump.

9. The device of claim 7 wherein the applicator includes a fingertip access port.

10. The device of claim 7 further comprising an interlock between the high voltage pulse-forming network and the power source wherein the laser is not dischargeable unless the interlock is defeated.

11. The device of claim 10 wherein the interlock is a spring-loaded interlock which is activated by depressing the applicator.

12. The device of claim 11 wherein the applicator and spring are placed so that the applicator is positioned to defeat the interlock upon compression of the spring, and the focal point of the beam is located within about 5 mm of the distal end of the applicator when the interlock is defeated.

13. The device of claim 7 wherein the applicator is positioned so that the beam is completely enclosed at the time of perforation by the housing, the applicator and the tissue to be perforated.

14. The device of claim 7 further comprising a means for heating the applicator wherein the means for heating the applicator is adjacent to the applicator.

15. The device of claim 14 wherein the means for heating the applicator comprises a thermoelectric heater.

16. The device of claim 1 wherein the power source is a battery pack.

17. The device of claim 16 wherein the battery pack is a rechargeable battery pack.

18. The device of claim 1 wherein the means for exciting the lasing material is selected from a flashlamp and a diode laser.

19. The device of claim 18 wherein the diode laser is anterior to the lasing material, and the laser beam from the diode laser is focused on the lasing material through a collimating lens.

20. The device of claim 1 further comprising a container unit, positioned between the lasing element and the tissue, for the collection of biological or other matter released by perforation of the tissue, through which the laser beam passes and wherein the container is closed except at the end proximal to the tissue.

21. The device of claim 20 wherein the container collects bodily fluids.

22. The device of claim 20 wherein the container collects ablated tissue.

23. The device of claim 20 wherein the container comprises a vacuum.

24. The device of claim 20 wherein the container further comprises a plug that conforms to the contours of the perforation site and is proximal to the perforation site.

25. The device of claim 24 wherein the plug maintains a vacuum in the container.

26. The device of claim 24 wherein the plug is constructed of a material that is impermeable to gas transfer.

27. The device of claim 24 wherein the plug is constructed of rubber.

28. The device of claim 24 wherein the plug includes a plug perforation center.

29. The device of claim 28 wherein the plug perforation center is constructed of rubber with a thickness in the range of approximately 100 to 500 microns.

30. The device of claim 20 wherein the container includes an entry for the laser beam.

31. The device of claim 30 wherein the entry for the laser beam is a window positioned in the pathway of the laser beam, wherein the window is transparent to the laser beam.

32. The device of claim 31 wherein the window comprises an infrared transmitting material.

33. The device of claim 30 wherein the window is constructed of a material selected from the group consisting of quartz, rock salt, germanium, and polyethylene.

34. The device of claim 30 wherein the entry for the laser beam is a hole positioned in the pathway of the laser beam.

35. The device of claim 20 wherein the container is coated with an anticoagulating chemical.

36. The device of claim 35 wherein the anticoagulating chemical is selected from sodium heparin and sodium citrate.

37. The device of claim 20 wherein the container is coated with a preservative.

38. The device of claim 37 wherein the preservative is selected from Ethylenediaminetetraacetic Acid and sodium benzoate.

39. The device of claim 20 wherein the container unit comprises a main receptacle, comprising

a) a rim against which the tissue is pressed;

b) a lens, at least partially transparent, through which the beam passes; and

c) a wall extending from the perimeter of the lens to the rim, enclosing the region between the tissue and the lens.

40. The device of claim 39 wherein the container unit further comprises a base.

41. The device of claim 40 wherein the base further comprises a means for activating the laser perforator device.

42. The device of claim 41 wherein the base further comprises a means for disengaging a safety mechanism on the laser perforator device.

43. The device of claim 39 wherein the container unit further comprises a vessel for the collection of liquid and/or particulate matter released by the perforation of the tissue.

44. The device of claim 43 wherein the vessel has an open end and the vessel further comprises a stop to be placed into the open end to keep contaminants out of the vessel.

45. The device of claim 1 wherein the focusing means focuses the beam from said lasing element in an elliptical shape capable of creating a slit in a patient'"'"'s tissue with a width between about 0.05 and about 0.5 mm and a length of equal to or less than about 2.5 mm.

46. The device of claim 45 wherein the width of the slit is about 0.2 mm and the length of the slit is about 1.0 mm.

47. The device of claim 1 wherein at the focal point one axis of the beam measures between about 0.05 and about 0.5 mm and the other axis of the beam measures less than or equal to about 2.5 mm.

48. A laser perforator device for perforating skin comprising

a) a lasing element which emits a pulsed beam;

b) a power source;

c) a high voltage pulse-forming network linked to the power source;

d) a means for exciting the lasing element, linked to the pulse-forming network;

e) a laser cavity;

f) a beam splitter positioned to create multiple beams emanating from the device; and

g) a focusing means which focuses each beam to an ellipse.

49. The device of claim 48 wherein the beam splitter is selected from a series of partially silvered mirrors, a series of dichroic mirrors, and a series of beam splitting prisms.

50. A laser perforator device for perforating skin comprising

a) a lasing element which emits a pulsed beam;

b) a power source;

c) a high voltage pulse-forming network linked to the power source;

d) a means for exciting the lasing element, linked to the pulse-forming network;

e) a laser cavity;

f) a focusing means which focuses the beam from said lasing element to an ellipse; and

an acousto-optic modulator outside the laser cavity wherein the modulator consecutively deflects the beam at different angles to create different sites of perforation on the skin.