Dynamic colorectal PDT application

• US 9,034,023 B2
• Filed: 01/24/2012
• Issued: 05/19/2015
• Est. Priority Date: 01/24/2011
• Status: Expired due to Fees

• Current Assignee: Biolitec Unternehmensbeteiligungs II AG
• Original Assignee: Biolitec Pharma Marketing Ltd.
• Inventors: Kruijt, Bastiaan, Amelink, Arjen, Robinson, Dominic J., Neuberger, Wolfgang, van der Snoek, Eric M, Sterenborg, Henricus J. C. M.
• Primary Examiner(s): Jackson, Gary
• Assistant Examiner(s): Nganga, Boniface N.
• Application Number:
  US13/357,319
• Publication Number:
  US 20120259187A1
• Time in Patent Office: 1,211 Days
• Field of Search: 600/317, 600476-479, 607 74- 95, 604/264
• US Class Current: 607/88
• CPC Class Codes: A61B 5/0071 by measuring fluorescence emission
• CPC Class Codes: A61B 5/0084 for introduction into the body, e.g. by catheters A61B5/1459 takes precedence
• CPC Class Codes: A61B 5/4255 Intestines, colon or appendix
• CPC Class Codes: A61K 31/409 having four such rings, e.g. porphine derivatives, bilirubin, biliverdine hemin, hematin A61K31/555
• CPC Class Codes: A61N 2005/0608 Rectum
• CPC Class Codes: A61N 2005/0628 including a radiation sensor
• CPC Class Codes: A61N 2005/063 comprising light transmitting means, e.g. optical fibres
• CPC Class Codes: A61N 2005/0662 Visible light
• CPC Class Codes: A61N 5/062 Photodynamic therapy, i.e. excitation of an agent
• CPC Class Codes: A61P 35/00 Antineoplastic agents

Abstract

Dynamic colorectal PDT methods, devices and photosensitizer compositions to treat abnormal cell growth in anal tissue such as perianal and intra-anal intraepithelial neoplasia grade III are presented. Dynamic colorectal PDT method comprises the steps of administering topically, intravenously or orally a photosensitizer composition; irradiating; monitoring treatment parameters before, during and/or after irradiation. Photosensitizer composition comprises Temoporfin and excipients/carriers, appropriate for the application method. An applicator is provided for colorectal PDT treatments enhancing irradiation delivery and monitoring treatment parameters. Preferably, applicator is made of a material, used to monitor the fluence rate simultaneously while doing optical spectroscopy. Measurement probe devices are provided for monitoring PDT treatment parameters in-vivo. A device for colorectal PDT treatment is also provided, comprising laser radiation source operating at about 400 and 800 nm; excitation laser radiation source operating at about 650 nm for fluorescence measurements; multichannel dosimetry device; long pass filter; waveguides and measurement probes.

Claims

1. A medical device for colorectal PDT treatment comprising;

a) at least one radiation source;

b) a multichannel dosimetry device;

c) a long pass filter;

d) an applicator having a distal end and a proximal end, being sized and adapted for the distal end to be inserted intra-anally and comprising;

     1) a center conduit extending along a longitudinal axis of the applicator,

     2) at least one measurement conduit sloped with respect to the center conduit such that the distal end of a probe inserted into the proximal end of the measurement conduit would point away from the distal end of the center conduit, and

     3) at least one measurement conduit at the surface of the applicator parallel to the center conduit;

e) at least one waveguide for insertion into the proximal end of the center conduit of the applicator;

f) at least one sloped measurement probe for insertion into the proximal end of the at least one sloped measurement conduit; and

g) at least one surface measurement probe for insertion into the proximal end of the at least one measurement conduit at the surface of the applicator.

2. The device for colorectal PDT treatments according to claim 1, wherein said radiation source is a coherent or incoherent radiation source selected from the group consisting of lasers, white light sources, light emitting diodes, lamps, and a combination of these whose output can be regulated within a preselected spectral window.

3. The device for colorectal PDT treatments according to claim 1, wherein said at least one waveguide is an optical fiber selected from the group consisting of radial optical fibers, linear diffusers, balloon optical fibers, bifurcated optical fibers and combination of these.

4. The device for colorectal PDT treatments according to claim 1, wherein said at least one radiation source is a laser radiation source operating at 400 to 800 nm optically connected to said at least one waveguide for insertion into the center conduit of the applicator.

5. The device for colorectal PDT treatments according to claim 1, wherein said at least one radiation source is an excitation laser radiation source operating at 650 nm for fluorescence measurements optically connected to said at least one surface measurement probe.

6. The device for colorectal PDT treatments according to claim 5, wherein said excitation laser radiation source is used with one or more laser beam splitters.

7. The device for colorectal PDT treatments according to claim 5, wherein a shutter is placed in the laser radiation path to control the excitation laser radiation for the at least one surface measurement probe.

8. The device for colorectal PDT treatments according to claim 1, wherein a data processing unit is used to manage fluorescence spectroscopy data, fluorescence differential path-length spectroscopy data, and signals measured with measurement probes.

9. The medical device for colorectal treatment according to claim 1 which comprises two measurement conduits sloped with respect to the center conduit and two measurement conduits opposite each other at the surface of the applicator.

10. The medical device for colorectal PDT treatment according to claim 9, wherein adjustable spacers are placed in the sloped conduits to prevent damage to the anal mucosa by inserting measurement probes.

11. The medical device for colorectal PDT treatment according to claim 9, wherein the slope of each of said sloped conduits from the longitudinal axis of the applicator is 35 degrees.

12. The medical device for colorectal PDT treatment according to claim 9, wherein said applicator further comprises a material which is used to monitor the fluence rate at the same time as doing optical spectroscopy.

13. The medical device for colorectal PDT treatment according to claim 12, wherein said material is a polymeric material which has a Raman peak from a C—

H stretch/an amide group.

14. The device for colorectal PDT treatment according to claim 1, wherein said sloped measurement probe comprises:

i) a hollow element of medical-grade metal;

ii) at least two waveguides, placed at a determined core-to-core distance of said hollow element of medical-grade metal; and

iii) a fluorescence differential path length spectroscopy control unit;

wherein said measurement probe'"'"'s outputs are processed with the aid of a fluorescence differential path length spectroscopy control unit.

15. The medical device for colorectal PDT treatment according to claim 14 wherein said waveguides have a slope at distal tips.

16. The medical device for colorectal PDT treatment according to claim 15, wherein said slope at the tip is about 35 degrees.

17. The medical device for colorectal PDT treatment according to claim 14, wherein at least one of said waveguides is a radiation delivery and radiation collector optical fiber.

18. The medical device for colorectal PDT treatment according to claim 14, wherein said hollow element of medical-grade metal is a stainless steel needle.

19. The medical device for colorectal PDT treatment according to claim 14, wherein at least one of said waveguides is a radiation collector optical fiber.