Method and apparatus for light-activated drug therapy

• US 10,307,610 B2
• Filed: 01/13/2017
• Issued: 06/04/2019
• Est. Priority Date: 01/18/2006
• Status: Active Grant

• Current Assignee: Light Sciences Oncology, Inc.
• Original Assignee: Light Sciences Oncology, Inc.
• Inventors: Keltner, Llew, Winship, Jay, Hagstrom, Erik, Zheng, Frank, Chen, James C., Hobbs, Joseph M.
• Primary Examiner(s): Roane, Aaron F
• Application Number:
  US15/406,057
• Publication Number:
  US 20170128741A1
• Time in Patent Office: 872 Days
• Field of Search: 607 88
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00274 Prostate operation, e.g. prostatectomy, turp, bhp treatment
• CPC Class Codes: A61B 2017/22068 Centering
• CPC Class Codes: A61B 2018/00285 Balloons
• CPC Class Codes: A61B 2018/00547 Prostate
• CPC Class Codes: A61B 2018/00821 measured by a thermocouple
• CPC Class Codes: A61B 2018/2261 with scattering, diffusion or dispersion of light
• CPC Class Codes: A61K 41/0071 PDT with porphyrins having exactly 20 ring atoms, i.e. based on the non-expanded tetrapyrrolic ring system, e.g. bacteriochlorin, chlorin-e6, or phthalocyanines
• CPC Class Codes: A61N 2005/0602 for treatment of blood vessels
• CPC Class Codes: A61N 2005/061 Bladder and/or urethra
• CPC Class Codes: A61N 2005/063 comprising light transmitting means, e.g. optical fibres
• CPC Class Codes: A61N 2005/0652 Arrays of diodes
• CPC Class Codes: A61N 5/0601 Apparatus for use inside the body
• CPC Class Codes: A61N 5/0603 for treatment of body cavities
• CPC Class Codes: A61N 5/062 Photodynamic therapy, i.e. excitation of an agent
• CPC Class Codes: A61N 5/067 using laser light

Abstract

A prostate treatment system having a light delivery device positionable in a transurethral device for treatment of benign prostatic hyperplasia (BPH). The light delivery device includes light generator, such as light emitting diodes (LED), laser diodes (LDs) or a diffusion quartz fiber tip connected to a light generator or a light emitting polymer which produces light at a selected wavelength or waveband or alternative sources of suitable light energy. The treatment device may further include a temperature monitoring system for monitoring the temperature at the treatment site. A light-activated drug is administered to the treatment site prior to light activation. The light-activated drug therapy induces cell death of the target tissue. The device provides a minimally invasive transurethral method for treatment of BPH or prostate cancer.

Claims

1. A transurethral light activated drug therapy device for the treatment of prostate conditions comprising:

an elongated support member configured to pass through the urethra, the elongated support member having a proximal end and a distal end;

a light delivery device having a light generator along the elongated support member and a light emitting region configured to be positioned within the urethra at least proximate to a treatment site, wherein the light generator is configured to generate light at a preselected wavelength or waveband in the range of an activation waveband of a photoactive composition; and

a positioning element carried by the elongated support member, wherein the positioning element is configured to locate the elongated support member within the urethra; and

wherein the elongated support member is a catheter having;

a first lumen for delivering fluid to the positioning element;

a second lumen for accommodating the light delivery device; and

a selective coating to control where light transmits to the prostatic tissue.

2. The transurethral light-activated drug therapy device of claim 1, wherein the light generator comprises at least one or more of a light emitting diode (LED), solid-state laser diode (LD), a light-emitting polymer, a laser, a light-emitting transistor, or another light source transmitting fiber through which light can be conducted.

3. The transurethral light-activated drug therapy device of claim 1 wherein the light generator comprises an array of LEDs having a size from 0.25 mm to 1 mm.

4. The transurethral light-activated drug therapy device of claim 3 wherein the array of LEDs is configured to provide 50 J/cm² to 1000 J/cm² of light fluence.

5. The transurethral light-activated drug therapy device of claim 4 wherein the array of LEDs is configured to provide 200 J/cm² of light fluence.

6. The transurethral light-activated drug therapy device of claim 3, further comprising a power controller configured to pulse the array according to a frequency or according to a timed pattern.

7. The transurethral light-activated drug therapy device of claim 3 wherein the array of LEDs has an operational frequency in the range from 50 Hz to 5 kHz.

8. The transurethral light-activated drug therapy system of claim 2, wherein the light generator comprises an array of LEDs and the array can move axially within the catheter.

9. The transurethral light-activated drug therapy system of claim 2, wherein the light generator comprises an array of LEDs and the array is fixed at a selected location within the catheter during treatment.

10. The transurethral light-activated drug therapy device of claim 1 wherein the light delivery device is fixed to the support member.

11. The transurethral light-activated drug therapy device of claim 1 wherein the positioning element includes a balloon at the distal end of the catheter.

12. The transurethral light-activated drug therapy system of claim 1 wherein the positioning element is a balloon, umbrella, tines, and/or disk.

13. The transurethral light-activated drug therapy system of claim 1 wherein the positioning element is retractable.

14. The transurethral light-activated drug therapy system of claim 1, further comprising echogenic markings on the distal end of the catheter or on the light source or both.

15. The transurethral light-activated drug therapy system of claim 1, further comprising positioning indicia on the proximal end of the catheter.

17. The transurethral light-activated drug therapy device of claim 1, wherein the elongated support member includes a third lumen, the third lumen being a urine lumen in connection to a urine collection bag.

18. The transurethral light-activated drug therapy device of claim 1, wherein the elongated support member includes a fourth lumen for accommodating a wire that connects a temperature sensor that measure a temperature at the treatment site to a temperature monitor.

16. A transurethral light-activate drug therapy system for the treatment of prostate conditions in a male animal having an enlarged prostate, comprising:

a photoreactive agent comprising mono-L-aspartyl chlorine e6; and

a transurethral light activate drug therapy device comprising;

a flexible elongated support member configured to pass through a urethra of the male animal, the flexible elongated support member having a proximal end and a distal end;

a light delivery device having a light generator carried by a distal region of the flexible elongated support member, the light generator and a light emitting region are configured to be positioned within the urethra to deliver light to the prostate, wherein the light generator is configured to generate a light band with a peak at a preselected wavelength of 664 nm radially at 360 degrees;

a power source external to the flexible elongated support member, in flexible electrical communication with the light generator; and

a positioning element carried by the flexible elongated support member,

wherein;

the positioning element is configured to locate the flexible elongated support member within the urethra;

a majority of the portion of the flexible elongated support member inserted into the urethra of the male animal does not permit light from the light generator to pass through;

a transparent or translucent, integral window along a portion of the length of the flexible elongated support member that is proximate to the prostate when the distal end of the support member is positioned in the bladder of the male animal and allows light from the light generator to pass through the window, and the window extends 360 degrees radially from the flexible elongated support member;

the length of the light generator is at least as long as a majority of the length of the window;

a majority of the length of the light generator is fixed in place within the window;

when the flexible elongated support member is completely removed from the urethra, the light generator is completely removed from the urethra; and

the flexible elongated support member is a catheter and comprises a selective coating to form the window to control where light transmits to the prostatic tissue;

a first longitudinal internal lumen through a majority length of the flexible elongated support member for delivering fluid to the positioning element; and

a second longitudinal internal lumen through the majority length of the flexible elongated support member for accommodating the light delivery device.

19. The transurethral light-activate drug therapy system of claim 16, wherein the transurethral light activate drug therapy device includes a third lumen, the third lumen being a urine lumen in connection to a urine collection bag.

20. The transurethral light-activate drug therapy system of claim 16, wherein the transurethral light activate drug therapy device includes a fourth lumen for accommodating a wire that connects a temperature sensor that measure a temperature at prostate to a temperature monitor.