METHOD AND APPARATUS FOR REMOVABLE CATHETER VISUAL LIGHT THERAPEUTIC SYSTEM

• US 20170224952A1
• Filed: 02/03/2017
• Published: 08/10/2017
• Est. Priority Date: 02/05/2016
• Status: Active Grant

• Current Assignee: Light Line Medical, Inc.
• Original Assignee: Light Line Medical, Inc.
• Inventors: Barneck, Mitchell D., Rhodes, Nathaniel L., Allen, James P., Long, Curtis D., de la Presa, Martin
• Granted Patent: US 10,543,338 B2
• Time in Patent Office: Days
• CPC Class Codes: A61M 2025/0019 Cleaning catheters or the like, e.g. for reuse of the device, for avoiding replacement
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61N 2005/0629 Sequential activation of light sources
• CPC Class Codes: A61N 2005/063 comprising light transmitting means, e.g. optical fibres
• CPC Class Codes: A61N 2005/0651 Diodes
• CPC Class Codes: A61N 2005/0654 Lamps
• CPC Class Codes: A61N 2005/0656 Chemical light sources
• CPC Class Codes: A61N 2005/0659 infrared
• CPC Class Codes: A61N 2005/0663 Coloured light
• CPC Class Codes: A61N 5/0601 Apparatus for use inside the body
• CPC Class Codes: A61N 5/062 Photodynamic therapy, i.e. excitation of an agent
• CPC Class Codes: A61N 5/0624 for eliminating microbes, germs, bacteria on or in the body
• CPC Class Codes: A61N 5/067 using laser light

Abstract

A medical device assembly is provided for removable insertion into a catheter with a lumen. The medical device assembly comprises an electromagnetic radiation (EMR) source for providing non-ultraviolet, therapeutic EMR having an intensity sufficient to inactivate one or more infectious agents and/or to stimulate healthy cell growth causing a healing effect, and a removable EMR conduction system at least partially insertable into and removable from the lumen of the catheter. The EMR conduction system has at least one optical element providing axial propagation of the therapeutic EMR through an insertable elongate body. The elongate body may have an exterior surface between a coupling end and a distal end tip that has at least one modified portion permitting the radial emission of therapeutic EMR from the elongate body proximate the modified portion. Such modified portion may be gradient along the exterior surface.

Claims

1. A medical device assembly for removable insertion into a catheter with a lumen, comprising:

an electromagnetic radiation (EMR) source for providing non-ultraviolet, therapeutic EMR having an intensity comprising a radiant exposure of at least 0.1 J/cm² and power of at least 0.005 mW, such intensity being sufficient to cause a therapeutic effect of at least one of inactivating one or more infectious agents and promoting healing;

a removable EMR conduction system at least partially insertable into and removable from the lumen of the catheter, the EMR conduction system comprising at least one optical element having an elongate body conducive to the axial propagation of the therapeutic EMR through the elongate body, the elongate body having an exterior surface between a proximal coupling end and an distal end tip, the exterior surface having at least one modified portion allowing the emission of therapeutic EMR radially from the elongate body; and

a coupling to connect the EMR source to the EMR conduction system.

2. The medical device assembly as in claim 1 wherein the EMR conduction system comprises a plurality of optical elements, wherein the elongate body of each optical element has a length and at least two of the elongate bodies have differing lengths such that elongate bodies of differing lengths terminate at varying distances from the coupling end of the elongate body.

3. The medical device assembly as in claim 1 wherein the optical element further comprises at least one optical feature selected from a group of optical features consisting of a reflective surface, an optically transmissible material, a lens, a fiber optic filament, and any combination thereof.

4. The medical device assembly as in claim 1 wherein the optical element is capable of transmitting more than one wavelength or intensity EMR.

5. The medical device assembly as in claim 1 further comprising at least one optical diversion element to redirect EMR from at least one of the electromagnetic source and the optical element into at least one of the fluid lines, the convergence chamber, and the catheter connection hub.

6. The medical device assembly as in claim 1 wherein the therapeutic EMR has a wavelength that ranges from above 380 nm to 900 nm.

7. The medical device assembly as in claim 1 wherein the EMR source has an adjustable duty cycle length.

8. The medical device assembly as in claim 1 wherein the EMR source is selected from a group consisting of a solid state laser, a semiconductor laser, a diode laser, a light emitting diode, a fluorescent, or an incandescent light source.

9. The medical device assembly as in claim 1, wherein at least one modified portion is progressively modified such that the intensity of the therapeutic EMR emitted through the modified portion is substantially equivalent along the length of the modified portion.

10. The medical device assembly as in claim 9 wherein the modified portion having intensity substantial equivalency is achieved through gradient modification, such gradient modification comprising at least one of physical and chemical modification of the exterior surface of the elongate body of the at least one optical element.

11. The medical device assembly as in claim 1 wherein at least a portion of the emission of EMR is non-axial and the non-axial emission is achieved through at least one of deflecting structures dispersed interior to the exterior surface of the elongate body and a core-cladding boundary.

12. A medical device assembly for insertion into a catheter with at least one lumen, comprising:

an electromagnetic radiation (EMR) source selected from a group consisting of a solid state laser, a semiconductor laser, a diode laser, and a light emitting diode, the EMR source for providing non-ultraviolet, therapeutic EMR having a wavelength in a range of above 380 nm to 904 nm and having an intensity comprising a radiant exposure of at least 0.1 J/cm² and power of at least 0.005 mW, such intensity being sufficient to cause a therapeutic effect of at least one of inactivating infectious agents and promoting healing;

an removable EMR conduction system at least partially insertable into and removable from the at least one lumen of the catheter, the EMR conductive system comprising at least one optical element having an elongate body conducive to the substantially axial propagation of the therapeutic EMR along the elongate body; and

at least one coupling to connect the radiation source to the EMR conduction system.

13. The medical device assembly as in claim 12 wherein the wavelength of the therapeutic EMR is selected from a group of wavelengths including wavelengths centered about 400 nm, 405 nm, 415 nm, 430 nm, 440 nm, 445 nm, 455 nm, 470 nm, 475 nm, 632 nm, 632.8 nm, 640 nm, 650 nm, 660 nm, 670 nm, 680 nm, 780 nm, 808 nm, 830 nm, and 904 nm.

14. The medical device assembly as in claim 12 wherein the therapeutic EMR comprises one or more of the selected wavelengths being emitted in at least one of alternating and parallel treatment patterns.

15. The medical device assembly as in claim 12 wherein power density of the therapeutic EMR is within a range from 0.1 mW/cm² to 1 W/cm².

16. The medical device assembly as in claim 12 wherein the radiant exposure of the therapeutic EMR is within a range from 1.0 mJ/cm² to 1.0 kJ/cm².

17. The medical device assembly as in claim 12 wherein the EMR conduction system does not preclude injecting a liquid simultaneously into or around the EMR conduction system residing within a catheter.

18. The method for effectively sterilizing a catheter having a lumen with an interior surface dimension while the catheter is disposed within a patient'"'"'s body, comprising the steps of:

inserting an EMR conduction system into the lumen, the EMR conduction system having an exterior surface dimension which is less than the interior surface dimension of the lumen;

transmitting a non-ultraviolet, sterilizing EMR into the EMR conduction system for an amount of time and at an intensity comprising a radiant exposure of at least 0.1 J/cm² and power of at least 0.005 mW, such intensity being sufficient to effectively sterilize at least a portion of the catheter; and

emitting non-ultraviolet, sterilizing EMR through at least a portion of the catheter;

19. The medical device assembly as in claim 18 wherein the catheter is translucent, permitting EMR to transmit into tissue surrounding the catheter within the patient'"'"'s body.

20. The medical device assembly as in claim 18 wherein at least a portion of the EMR conduction system comprises radiopacifiers to facilitate visualization within the patient'"'"'s body.