Flexible microcircuits for internal light therapy

• US 5,800,478 A
• Filed: 03/07/1996
• Issued: 09/01/1998
• Est. Priority Date: 03/07/1996
• Status: Expired due to Term

• Current Assignee: Purdue Pharmaceutical Products LP (Purdue Pharma L.P.)
• Original Assignee: Light Sciences Limited Partnership
• Inventors: Chen, James C., Wiscombe, Brent
• Primary Examiner(s): Bahr, Jennifer
• Assistant Examiner(s): YARNELL, BRYAN KEITH
• Application Number:
  US08/613,390
• Time in Patent Office: 908 Days
• Field of Search: 607/88, 607/89, 607/90, 607/92, 607/116, 607/152, 607/129, 606/14, 606/15, 606/16, 606/17, 606/10, 604/19, 604/20, 604/21, 600/373-375, 600/377
• US Class Current: 607/88
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00274 Prostate operation, e.g. prostatectomy, turp, bhp treatment
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61B 2017/0458 Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2018/00547 Prostate
• CPC Class Codes: A61N 2005/061 Bladder and/or urethra
• CPC Class Codes: A61N 2005/0645 Applicators worn by the patient
• 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 5/062 Photodynamic therapy, i.e. excitation of an agent

Abstract

A plurality of embodiments for a flexible probe used to provide photodynamic therapy (PDT) and to effect other medical procedures at an internal treatment site inside a patient'"'"'s body. Each of the embodiments of the flexible probe (100, 108, 130, 158, 182, 190, 220, 280, 370, 390, 440, 460, 520) includes a flexible substrate (102, 184, 196, 222, 250, 282, 412, 462, 482, 502, 522) on which are disposed conductive traces (414, 466, 468, 488, 490, 504, 506, 524, 526) electrically connected to leads through which electrical current and signals are conveyed. A plurality of light sources (104, 192, 256, 286, 418, 436, 470, 492, 508, 542) or other micro-electronic circuits are connected to the conductive traces and mounted on the flexible substrate. Each of the embodiments of the flexible probes is enclosed within a transparent, biocompatible polymer envelope (106, 110, 464, 522). Due to the characteristic elastic properties of the flexible substrate, the flexible probe can readily be bent, folded, or rolled while being disposed at the internal treatment site, thereby enabling the probe to pass through a guide tube (120), an incision, a catheter (150), or a lumen(154) of relatively small cross-sectional diameter. Once disposed at the treatment site, a folded or rolled flexible probe can be unfolded or unrolled to supply light for PDT, or energized to provide other types of medical treatment.

Claims

1. Apparatus for effecting a medical treatment at an internal site within a patient'"'"'s body, comprising:

(a) a flexible substrate;

(b) a plurality of conductive traces affixed to the flexible substrate, said conductive traces being sufficiently flexible to bend with the flexible substrate without breaking or separating from the flexible substrate as the flexible substrate is flexed during its insertion into a patient'"'"'s body and advanced to the internal site;

(c) an electrical device disposed on the flexible substrate and coupled to the plurality of conductive traces, said electrical device being carried by the flexible substrate for disposition at the internal site;

(d) a biocompatible, flexible envelope hermetically enclosing the flexible substrate, the plurality of conductive traces, and the electrical device; and

(e) a plurality of electrical leads connected to the conductive traces, said electrical leads being adapted to couple to a source of electrical power in order to energize the electrical device, and being operative to carry signals between the electrical device and a different location.

2. The apparatus of claim 1, wherein the flexible substrate comprises a strip having a thickness, a width, and a length, said thickness of the strip being substantially less than its width, and said width of the strip being substantially less than its length.

3. The apparatus of claim 1, wherein said electrical device comprises at least one micro-electronic circuit.

4. The apparatus of claim 1, wherein the flexible substrate comprises a sheet having a thickness and a width, said thickness of the sheet being substantially less than its width.

5. The apparatus of claim 4, wherein the flexible substrate is sufficiently flexible to be rolled into a tubular shape for insertion into the patient'"'"'s body, said tubular shape having a substantially smaller transverse cross-sectional dimension than the width of said flexible substrate, prior to being rolled.

6. The apparatus of claim 1, wherein the flexible substrate is sufficiently flexible to be folded into a more compact shape without damage.

7. The apparatus of claim 6, wherein the flexible substrate is folded at about a midpoint, being thereby adapted to form a loop that is collapsed for insertion into the patient'"'"'s body, said loop opening to form an open loop at the internal site.

8. Apparatus for administering light to a treatment site within a patient'"'"'s body, comprising:

(a) a flexible substrate serving as a support;

(b) conductive traces affixed to the flexible substrate, said conductive traces being sufficiently flexible to bend with the flexible substrate without breaking or separating from the flexible substrate, thereby enabling the apparatus to be flexed when being inserted into the patient'"'"'s body and when being disposed at the treatment site within the patient'"'"'s body;

(c) at least one light source electrically coupled to the conductive traces and mounted to the flexible substrate;

(d) a plurality of electrical leads connected to the conductive traces, said electrical leads being adapted to couple to a source of electrical power in order to energize said at least one light source to emit light that is incident on the treatment site within the patient'"'"'s body; and

(e) a flexible envelope of a transparent material that hermetically encloses said at least one light source, the conductive traces, and the flexible substrate, said flexible envelope transmitting light emitted from said at least one light source to the treatment site.

9. The apparatus of claim 8, wherein the flexible substrate comprises a sheet that is generally quadrilateral in shape.

10. The apparatus of claim 8, further comprising a plurality of light sources that are spaced apart on the flexible substrate, forming an array.

11. The apparatus of claim 10, wherein the flexible substrate is folded to form a flattened loop for insertion into the patient'"'"'s body, said flattened loop expanding into an open loop when the flexible substrate is disposed at the treatment site.

12. The apparatus of claim 8, wherein the flexible substrate is curved, so that when inserted into the patient'"'"'s body for use at a treatment site comprising a lumen, the flexible substrate conforms to a shape of the lumen, with said at least one light source illuminating a surface of the lumen.

13. The apparatus of claim 8, wherein the flexible substrate is rolled to minimize its cross-sectional size for insertion within the patient'"'"'s body and disposition at the treatment site, said flexible substrate being unrolled to administer light to the treatment site.

14. The apparatus of claim 8, wherein the flexible substrate is folded to reduce its cross-sectional area relative to a width of the flexible substrate, adapting the flexible substrate for insertion within the patient'"'"'s body and disposition at the treatment site, where the flexible substrate is then unfolded to administer light to the treatment site.

15. The apparatus of claim 8, further comprising an electromagnetic receiver that is connected to the electrical leads, said electromagnetic receiver being adapted to electromagnetically couple to a source of electrical power that is disposed outside the patient'"'"'s body, and thereby to provide an electrical current for energizing said at least one light source.

16. The apparatus of claim 15, wherein the electromagnetic receiver comprises an electromagnetic coil.

17. The apparatus of claim 15, wherein the electromagnetic receiver comprises a radio frequency receiver that receives radio frequency energy from an external source.

18. The apparatus of claim 8, wherein the flexible substrate has a predetermined configuration when not constrained and is thus adapted to be inserted into a treatment site in a restrained configuration and brought into contact with tissue at the treatment site so that said tissue contacts the flexible substrate and maintains the flexible substrate in its restrained configuration, a characteristic elasticity of said flexible substrate adapting it to change shape and flex radially outwardly toward its unconstrained configuration as any abnormal tissue at the treatment site shrinks in response to light emitted by said at least one light source.

19. The apparatus of claim 8, further comprising a catheter through which the flexible substrate is guided to the treatment site inside the patient'"'"'s body.

20. The apparatus of claim 8, wherein the source of electrical power comprises a battery.

21. The apparatus of claim 8, further comprising a plurality of light sources, including two different sets of light sources, each set of light sources when energized, emitting light having a characteristic peak wavelength substantially different than the characteristic peak wavelength of the light emitted by the light sources comprising the other set.

22. The apparatus of claim 21, wherein each set of light sources is selectively energized to determine the wavelength of the light emitted by the apparatus.

23. The apparatus of claim 21, wherein some of the light sources are coupled to the conductive traces with a polarity opposite that of others of the light sources, so that a polarity of the voltage supplied to the conductive traces determines which light sources are energized.

24. The apparatus of claim 8, further comprising a source of infrared light and an infrared light photovoltaic receiver, said source of infrared light being adapted to couple to a power supply and when energized thereby, to emit infrared light that passes transcutaneously into a patient'"'"'s body to energize the infrared light photovoltaic receiver, said infrared photovoltaic receiver producing an electric current in response thereto and being coupled to the electrical leads to energize said at least one light source.

25. A method for effecting a medical treatment at an internal site within a patient'"'"'s body, comprising the steps of:

(a) providing an electrical device that is mounted on a flexible substrate in contact with a plurality of conductive traces disposed on the flexible substrate, said electrical device, said plurality of conductive traces, and said flexible substrate being hermetically sealed within a biocompatible, flexible envelope that encloses the electrical device, the plurality of conductive traces, and the flexible substrate;

(b) supplying electrical power to the electrical device through the conductive traces;

(c) inserting the flexible substrate and electrical device into the patient'"'"'s body by flexing the flexible substrate to reduce its size in at least one dimension or to enable it to pass through a curved lumen; and

(d) positioning and deploying the flexible substrate and electrical device at the internal site to facilitate use of the electrical device.

26. The method of claim 25, wherein the flexible substrate comprises a strip having a thickness, a width, and a length, said thickness of the strip being substantially less than its width, and said width of the strip being substantially less than its length.

27. The method of claim 25, wherein said step of providing the electrical device comprising the step of mounting at least one micro-electronic circuit on the flexible substrate.

28. The method of claim 25, wherein the flexible substrate comprises a sheet having a thickness and a width, said thickness of the sheet being substantially less than its width;

said step of providing the electrical device comprising the step of mounting at least one micro-electronic circuit on the sheet.

29. The method of claim 25, wherein the flexible substrate is sufficiently flexible to be rolled into a tubular shape for insertion into the patient'"'"'s body, said step of inserting including the step of rolling the flexible substrate into a tubular shape having a substantially smaller transverse cross-sectional dimension than the width of said flexible substrate prior to being rolled.

30. The method of claim 25, wherein the flexible substrate is sufficiently flexible to be folded, said step of inserting including the step of folding the flexible substrate into a shape having a substantially smaller transverse cross section than said flexible substrate prior to being folded.

31. The method of claim 30, further comprising the step of folding the flexible substrate at about a midpoint, thereby forming the flexible substrate in a collapsed loop for insertion into the patient'"'"'s body, wherein said step of positioning and deploying comprises the step of opening said collapsed loop to form an open loop at the internal site.

32. A method for administering light therapy to an internal treatment site within a patient'"'"'s body, comprising the steps of:

(a) providing at least one light source mounted on a flexible substrate in electrical contact with conductive traces disposed on the flexible substrate, said at least one light source, said flexible substrate, and said conductive traces being hermetically sealed within a biocompatible flexible envelope that is generally transparent to light emitted by said at least one light source;

(b) supplying electrical power to said at least one light source through the conductive traces;

(c) inserting the flexible substrate and said at least one light source into the patient'"'"'s body by flexing the flexible substrate to reduce a size of the flexible substrate in at least one dimension sufficiently to fit within an opening into the patient'"'"'s body;

(d) positioning the flexible substrate at the treatment site; and

(e) irradiating the treatment site with light emitted by said at least one light source to effect the light therapy.

33. The method of claim 32, wherein the step of inserting comprises the step of folding the flexible substrate, thereby enabling the flexible substrate and said at least one light source to be inserted into the patient'"'"'s body through a lumen having a cross section that is smaller than a width of the flexible substrate prior to being folded.

34. The method of claim 32, wherein the step of inserting comprises the step of rolling the flexible substrate into a tubular shape to reduce its transverse size, thereby enabling the flexible substrate and said at least one light source to be inserted into the patient'"'"'s body through a lumen having a cross-sectional dimension that is less than a width of the flexible substrate prior to the flexible substrate being rolled.

35. The method of claim 32, wherein the step of inserting comprises the step of bending the flexible substrate to enable the flexible substrate to pass through a curved lumen to reach the internal treatment site.

36. The method of claim 32, wherein the step of positioning the flexible substrate comprises the step of forming the flexible substrate around a surface contour of the internal treatment site within the patient'"'"'s body.

37. The method of claim 32, wherein the step of positioning the flexible substrate comprises the step of bending the flexible substrate to enable it to fit within a body cavity, said cavity enclosing the internal treatment site within the patient'"'"'s body.

38. The method of claim 32, further comprising the steps of securing the flexible substrate in a restrained configuration prior to inserting the flexible substrate into the patient'"'"'s body, and after the flexible substrate is disposed at the treatment site, releasing the flexible substrate to deploy the flexible substrate in an unrestrained configuration at the internal treatment site.

39. The method of claim 32, further comprising the step of energizing said at least one light source using a power source that is external to the patient'"'"'s body.

40. The method of claim 32, further comprising the step of energizing said at least one light source with an electrical current that is conveyed to the conductive traces through leads that extend outside the patient'"'"'s body.

41. The method of claim 32, wherein said at least one light source mounted on the flexible substrate is enclosed within a flexible, transparent material.

42. The method of claim 32, wherein the step of inserting comprises the step of guiding the flexible substrate to the treatment site through a catheter.

43. The method of claim 32, wherein the step of positioning comprises the step of pulling the flexible substrate through a body lumen to the treatment site by applying force to a line that is coupled to the flexible substrate to move the flexible substrate.

44. The method of claim 32, further comprising the step of creating a transcutaneous opening into the patient'"'"'s body for insertion of the flexible substrate.

45. The method of claim 32, further comprising the step of providing a balloon in fluid communication with a lumen that extends outside the patient'"'"'s body, said balloon being inflated at an opening into an organ in which the internal treatment site is disposed, to restrain the flexible substrate within the organ at the internal treatment site.

46. The method of claim 32, wherein the step of positioning comprises the step of securing the flexible substrate in a fixed position at the internal treatment site within the patient'"'"'s body.

47. The method of claim 32, further comprising the step of providing a plurality of light sources that are mounted on the flexible substrate, arranged in a spaced apart array.

48. The method of claim 47, wherein the plurality of light sources include two sets of light sources, each set of light sources emitting light having a characteristic peak wavelength that is substantially different than the characteristic peak wavelength of light emitted by the other set of light sources.

49. The method of claim 48, further comprising the step of selectively energizing only one of the sets of the light sources at one time.

50. The method of claim 48, further comprising the steps of coupling some of the light sources to the conductive traces with a different polarity than used to couple other of the light sources to the conductive traces;

and, applying a voltage of a selected polarity to the conductive traces to selectively energize only the light sources coupled to the conductive traces so as to be energized by said voltage.

51. The method of claim 32, wherein the steps of supplying electrical power comprises the step of transmitting infrared light transcutaneously into a patient'"'"'s body;

receiving the infrared light inside the patient'"'"'s body; and

, converting the infrared light into an electrical current that is used to energize said at least one light source.