Intracavity laser phototherapy method

• US 4,998,930 A
• Filed: 08/04/1989
• Issued: 03/12/1991
• Est. Priority Date: 08/03/1988
• Status: Expired due to Term

• Current Assignee: Phototherapeutic Systems A CA Partnership
• Original Assignee: Phototherapeutic Systems
• Inventors: Lundahl, Scott L.
• Primary Examiner(s): Hindenburg, Max
• Application Number:
  US07/374,664
• Time in Patent Office: 585 Days
• Field of Search: 606/13-16, 128/395-398
• US Class Current: 606/15
• CPC Class Codes: A61B 2017/00066 intensity
• CPC Class Codes: A61B 2017/22059 transparent
• CPC Class Codes: A61B 2017/22087 photodynamic
• CPC Class Codes: A61B 2018/2261 with scattering, diffusion or dispersion of light
• CPC Class Codes: A61N 2005/061 Bladder and/or urethra
• 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 5/0603 for treatment of body cavities
• CPC Class Codes: A61N 5/062 Photodynamic therapy, i.e. excitation of an agent

Abstract

A method is disclosed for the uniform irradiation of the inner wall of a hollow organ, including the steps of inserting a catheter having a deflated translucent balloon into the interior of the organ; inflating the balloon until it forms a predetermined configuration and distends the inner wall of the organ to be irradiated into a contiguous and congruent configuration; inserting a light transmission fiber having an isotropic light diffuser tip into the catheter so that the tip is positioned at the center of the balloon and, hence, automatically positioned at the center of the wall to be irradiated; and transmitting light through the fiber out the tip whereby light of uniform intensity irradiates the wall.

Claims

1. A method for the uniform irradiation of the inner wall of a hollow cavity, including the steps of:

(a) providing a catheter having a deflated translucent balloon, the balloon having a wall;

(b) inserting the catheter into the interior of the cavity;

(c) inflating the balloon until the balloon wall forms a generally spherical balloon configuration and distends at least one portion of an inner wall of the cavity to be irradiated into a contiguous and congruent generally spherical cavity configuration;

(d) inserting a light transmission fiber having a light diffuser tip into the catheter so that the tip is positioned at a center of the inflated balloon and, hence, automatically positioned at a uniform distance from the at least one portion of the cavity wall to be irradiated; and

(e) transmitting light through the transmission fiber out the tip

(e-1) whereby light of uniform intensity irradiates the at least one portion of the cavity wall.

2. The method of claim 1 wherein

(a-1) the balloon is made, in step (a), of minimally distensible material and

(c-1) the cavity is a human viscus, at least one portion of which cavity is formed in step (c) into a nearly perfectly spherical cavity configuration.

3. A method for the uniform irradiation of the inner wall of a hollow cavity, including the steps of:

(a) providing a catheter having a deflated translucent balloon, the balloon having a wall;

(a-1) providing, in step (a), at least one optical sensing fiber at the wall of the balloon;

(b) inserting the catheter into the interior of the cavity;

(c) inflating the balloon until the balloon wall forms a generally spherical balloon configuration and distends at least one portion of an inner wall of the cavity to be irradiated into a contiguous and congruent generally spherical cavity configuration;

(d) inserting a light transmission fiber having a light diffuser tip into the catheter so that the tip is positioned at a center of the inflated balloon and, hence, automatically positioned at a uniform distance from the at least one portion of the cavity wall to be irradiated;

(e) transmitting light through the transmission fiber out the tip

(e-1) whereby light of uniform intensity irradiates the at least one portion of the cavity wall; and

(f) monitoring with the sensing fiber on the wall of the cavity the light to which the sensing fiber and, hence, the cavity wall are exposed.

4. The method of claim 3, further including:

(a-2) providing, in step (a), a transparent minimally distensible center tube extending the length of the balloon through the center of the balloon for positioning the tip at the center of the balloon when the balloon is inflated in step (c).

5. The method of claim 3, wherein

(b-1) the cavity is a human bladder;

and further including;

(a-2) concentrating, prior to step (b), a photoactivating drug in diseased cells in the bladder wall for treatment and destruction of the diseased cells;

and wherein

(e-2) substantially the entire inner bladder wall is irradiated in step (e).

6. The method of claim 5, further including:

(a-3) providing the catheter, in step (a), with a flexible stem having an upper distal end to which the balloon is attached and through an inner lumen of which stem the light transmission fiber and diffuser tip of step (d) pass.

7. The method of claim 6, further including the steps of:

(g) providing at least one drainage port in fluid communication with the inner lumen of the stem; and

(h) draining urine from the bladder through the drainage port.

8. The method of claim 7 wherein

(e-3) the light is laser radiation and

(d-1) the fiber is quartz.

9. The method of claim 3, further including:

(a-2) providing, in step (a), at least one segment of the balloon which is opaque so that sections of the cavity underlying the at least one opaque segment will not be irradiated in step (e).

10. The method of claim 3, further including the steps of:

(a-2) concentrating, prior to step (b), a photoactivating drug in diseased cells in the cavity wall for treatment and destruction of the diseased cells; and

(g) measuring the concentration of photoactivating drug present in the cavity wall by measuring, with the at least one optical sensing fiber at the wall of the balloon, a fluorescent spectrum emitted by the drug during excitation by light.

11. A method for the uniform irradiation of the inner wall of a hollow cavity, including the steps of:

(a) providing a catheter having a deflated translucent balloon, the balloon having a wall;

(a-1) making the balloon, in step (a), of minimally distensible material;

(a-2) providing, in step (a), at least one optical sensing fiber at the wall of the balloon;

(b) inserting the catheter into the interior of the cavity;

(c) inflating the balloon until the balloon wall forms a generally spherical balloon configuration and distends at least one portion of an inner wall of the cavity to be irradiated into a contiguous and congruent generally spherical cavity configuration;

(c-1) the cavity being a human viscus, at least one portion of which cavity is formed in step (c) into a nearly perfectly spherical cavity configuration;

(d) inserting a light transmission fiber having a light diffuser tip into the catheter so that the tip is positioned at a center of the inflated balloon and, hence, automatically positioned at a uniform distance from the at least one portion of the cavity wall to be irradiated;

(e) transmitting light through the transmission fiber out the tip

(e-1) whereby light of uniform intensity irradiates the at least one portion of the cavity wall; and

(f) monitoring with the sensing fiber the cumulative light does to which the sensing fiber and, hence, the cavity wall are exposed.

12. A method for the uniform irradiation of the inner wall of a hollow cavity, including the steps of:

(a) providing a catheter having

(a-1) a deflated translucent balloon, the balloon having a wall, and

(a-2) at least one optical sensing fiber at the wall of the balloon;

(b) inserting the catheter into the interior of the cavity;

(c) inflating the balloon until the balloon wall forms a semi-rigid predetermined balloon configuration and distends at least one portion of an inner wall of the cavity to be irradiated into a contiguous and congruent cavity configuration;

(d) inserting a light transmission fiber having a light diffuser tip into the catheter so that the tip is positioned at a center of the inflated balloon and, hence, automatically positioned at a uniform distance from the at least one portion of the cavity wall to be irradiated;

(e) transmitting light through the transmission fiber out the tip

(e-1) whereby light of uniform intensity irradiates the at least one portion of the cavity wall; and

(f) monitoring with the sensing fiber on the wall of the cavity the light to which the sensing fiber and, hence, the cavity wall are exposed.

13. The method of claim 12 wherein

(a-3) the balloon is made, in step (a), of minimally distensible material and

(c-1) the cavity is a human viscus, at least one portion of which cavity is formed in step (c) into a cavity configuration which is at least a section of a nearly perfect sphere.

14. The method of claim 13, further including:

(a-4) providing, in step (a), a transparent minimally distensible center tube extending the length of the balloon through the center of the balloon for positioning the tip at the center of the balloon when the balloon is inflated in step (c).

15. The method of claim 12, further including the steps of:

(a-3) concentrating, prior to step (b), a photoactivating drug in diseased cells in the cavity wall for treatment and destruction of the diseased cells; and

(g) measuring the concentration of photoactivating drug present in the cavity wall by measuring, with the at least one optical sensing fiber at the wall of the balloon, a fluorescent spectrum emitted by the drug during excitation by light.

16. The method of claim 12, further including:

(a-3) providing, in step (a), at least one segment of the balloon which is opaque so that sections of the cavity underlying the at least one opaque segment will not be irradiated in step (e).

17. A method of treating and causing necrosis of diseased cells on the inner wall of a urinary bladder without over-treating healthy bladder cells, in which diseased cells a photoactivating drug has previously been concentrated, including the steps of:

(a) providing a catheter having

(a-1) a deflated translucent balloon of minimally distensible material,

(a-2) at least one optical sensing fiber in the material of the balloon,

(a-3) a clear minimally distensible center tube extending the length of the balloon through the balloon center, and

(a-4) a flexible stem having an upper distal end to which the balloon is attached, the stem having an inner lumen;

inserting the catheter into the interior of the bladder;

(c) inflating the balloon until it forms a semi-rigid balloon sphere and distends the inner wall of the bladder into a contiguous and congruent bladder sphere;

(d) inserting a laser light transmission fiber having an isotropic light diffuser tip into the inner lumen of the stem of the catheter so that the tip is positioned at the spherical center of the balloon and, hence, automatically positioned at the spherical center of the distended bladder;

(e) transmitting laser light radiation through the transmission fiber out the tip; and

(f) monitoring with the sensing fiber the cumulative light dose to which the bladder wall is exposed

(f-1) whereby laser light of uniform intensity irradiates the bladder, causing a photochemical reaction of the drug and destroying the diseased cells without over-irradiating healthy bladder cells.

18. The method of claim 17, further including the steps of:

(f-2) exciting, as part of step (f), the photoactivating drug by light; and

(g) measuring the concentration of photoactivating drug present in diseased cells by measuring, with the at least one optical sensing fiber in the material of the balloon, a fluorescent spectrum emitted by the drug during the excitation by light.

19. A method for the uniform irradiation of the inner wall of a hollow cavity, including the steps of:

(a) providing a catheter having a deflated translucent balloon, the balloon having a wall;

(b) inserting the catheter into the interior of the cavity;

(c) inflating the balloon until the balloon wall forms a spherical balloon configuration and distends at least one portion of an inner wall of the cavity to be irradiated into a contiguous and congruent spherical cavity configuration;

(d) inserting a light transmission fiber having a light diffuser tip into the catheter so that the tip is positioned at a center of the inflated balloon and, hence, automatically positioned at a uniform distance from the at least one portion of the cavity wall to be irradiated; and

(e) transmitting light through the transmission fiber out the tip

(e-1) whereby light of uniform intensity irradiates the at least one portion of the cavity wall.