Implanting and fixing a flexible probe for administering a medical therapy at a treatment site within a patient'body

• US 5,766,234 A
• Filed: 04/16/1996
• Issued: 06/16/1998
• 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:
  US08/633,171
• Time in Patent Office: 791 Days
• Field of Search: 128/642, 128/898, 128/899, 606/1, 606/2, 606/13, 606/14, 607/88, 607/89.92, 607/115, 607/116, 607/129, 607/132, 604/19, 604/20, 604/21
• US Class Current: 607/92
• 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. Thus, for example, a curved surgical needle (650) can be used to implant a flexible probe at the treatment site by drawing the flexible probe through tissue along a curved path to a desired position; one or more disk-shaped buttons (660, 670) that are attached to the ends of the flexible probe can be used to secure the flexible probe so that it does not move from the desired position.

Claims

1. A method for implanting and fixing a flexible probe in a desired position at a treatment site within a patient'"'"'s body, comprising the steps of:

(a) providing a flexible probe that comprises an elongate strip having sufficient flexibility to sustain deformation and bending without damage;

(b) attaching the strip to a surgical needle;

(c) forcing the surgical needle through tissue to the treatment site within the patient'"'"'s body, so that the strip comprising the flexible probe is drawn into the tissue by the surgical needle, along a path followed by the surgical needle;

(d) once the strip is implanted with the surgical needle in the desired position at the treatment site, disconnecting the surgical needle from the strip;

(e) withdrawing the surgical needle from the tissue, leaving the strip disposed in the desired position within the patient'"'"'s body to administer the medical treatment to the treatment site;

(f) securing one end of the strip to a first object, said first object serving to anchor the strip in the desired position at the treatment site, preventing movement of the strip relative to the treatment site; and

(g) securing a second object to another end of said strip after the strip is disposed at the desired position, said second object including a sleeve that slips over the strip.

2. The method of claim 1, further comprising the step of securing the first object to a tissue surface in the patient'"'"'s body.

3. The method of claim 1, wherein said second object further serves to anchor the strip in the desired position at the treatment site, preventing movement of the strip relative to the treatment site.

4. The method of claim 1, wherein the second object includes a lead that is coupled to the strip.

5. The method of claim 1, wherein the steps of securing the second object comprises one of the steps of:

crimping the sleeve of the second object about the strip, adhesively connecting the second object to the strip, connecting the second object to the strip with a threaded fastener, connecting the second object to the strip with a pin that extends through the sleeve and into the strip, and suturing the second object to the strip.

6. The method of claim 1, wherein the step of forcing the surgical needle includes one of the steps of:

grasping the surgical needle with a needle holder, and pulling the surgical needle into the desired position with forceps.

7. A medical procedure for implanting and stabilizing a flexible probe at a desired position within a patient'"'"'s body, said flexible probe being used for effecting a light therapy at a treatment site proximate the desired position, comprising the steps of:

(a) providing a strip of a flexible substrate on which is disposed a light source for effecting the light therapy, said strip having a cross-sectional dimension, and a length, said length of the strip being substantially greater than its cross-sectional dimension;

(b) coupling a distal end of the strip to a pointed instrument;

(c) forcing the pointed instrument through tissue in the body of the patient, so that the pointed instrument draws the strip after it into the desired position at the treatment site;

(d) decoupling the strip from the pointed instrument; and

(e) withdrawing the pointed instrument from the patient'"'"'s body, leaving the strip and the light source disposed at the desired location to administer the light therapy to the treatment site.

8. The method of claim 7, further comprising the step of securing the strip so that it does not move from the desired position.

9. The method of claim 8, wherein the step of securing comprises the step of coupling an object having a relatively larger cross-sectional size than the strip to at least one end of the strip.

10. The method of claim 8, wherein the step of securing comprises the step of coupling an object having a relatively larger cross-sectional size than the strip to both ends of the strip.

11. The method of claim 8, wherein the step of securing comprises the step of coupling the strip using one of an adhesive, a crimped sleeve, a threaded fastener, a pin, and a suture.

12. The method of claim 7, wherein the pointed instrument comprises a surgical needle.

13. The method of claim 7, further comprising the steps of passing a lead from the strip through an opening in an object;

and fastening the object to the lead to secure the strip in the desired position, said lead extending proximally beyond the object to a different location.

14. The method of claim 7, wherein a distal end of the strip is secured to an object that is disposed against a tissue surface to prevent movement of the strip from the desired position at the treatment site.

15. Apparatus adapted for administering a light therapy to a treatment site disposed within a patient'"'"'s body, comprising:

(a) a flexible strip having a width and a length, said width being substantially less than said length of the flexible strip, a light source being disposed on the flexible strip for effecting the light therapy at the treatment site;

(b) a pointed instrument for defining a path through the tissue in the patient'"'"'s body, said path being used for delivering the flexible strip to the treatment site in the patient'"'"'s body; and

(c) means for drawing the flexible strip behind the pointed instrument along the path through tissue in the patient'"'"'s body so that the flexible strip is disposed in a desired position at the treatment site, and so that the light source is thereby enabled to administer the light therapy to the treatment site.

16. The apparatus of claim 15, further comprising an object attachable to the flexible strip, said object being attached to at least one end of the flexible strip after the flexible strip is introduced to the treatment site, to secure the flexible strip in the desired position, preventing the flexible strip from moving away from the desired position.

17. The apparatus of claim 15, wherein the object includes a sleeve that is sized to fit over an end of the flexible strip and to be secured thereto.

18. The apparatus of claim 17, wherein the sleeve is secured to the flexible strip by one of a crimp of the sleeve, an adhesive, a threaded fastener, a pin that extends through the sleeve, and a suture.

19. The apparatus of claim 17, wherein the object includes an opening, and wherein the flexible strip is attached to a lead that extends from the flexible strip to another location, said lead passing through the opening in the object and being secured to the object to prevent movement of the flexible strip away from the desired position.

20. The apparatus of claim 15, wherein the pointed instrument comprises a surgical needle.

21. A method for implanting and fixing a flexible probe in a desired position at a treatment site within a patient'"'"'s body to deliver a light therapy to the treatment site, comprising the steps of:

(a) providing a flexible probe that comprises an elongate strip having sufficient flexibility to sustain deformation and bending without damage, said flexible strip including a plurality of light sources for effecting the light therapy;

(b) forcing a pointed instrument through tissue to the treatment site within the patient'"'"'s body, creating a path through the tissue;

(c) drawing the strip comprising the flexible probe into the tissue, along the path followed by the pointed instrument; and

(d) once the strip is implanted at the treatment site, administering the light therapy to the treatment site with the plurality of light sources.

22. The method of claim 21, wherein a line is coupled to the pointed instrument so that the line is drawn through the tissue behind the pointed instrument and extends behind the pointed instrument along the path followed thereby, wherein the step of drawing the strip comprises the step of coupling the strip to the line and pulling the line along the path through the tissue to advance the strip into the treatment site.

23. The method of claim 21, wherein the strip is coupled to the pointed instrument and is drawn into the treatment site as the pointed instrument is advanced.

24. A method for implanting and fixing a flexible probe in a desired position at a treatment site within a patient'"'"'s body, comprising the steps of:

(a) providing a flexible probe that comprises an elongate strip having sufficient flexibility to sustain deformation and bending without damage;

(b) attaching the strip to a surgical needle;

(c) forcing the surgical needle through tissue to the treatment site within the patient'"'"'s body, so that the strip comprising the flexible probe is drawn into the tissue by the surgical needle, along a path followed by the surgical needle;

(d) once the strip is implanted with the surgical needle in the desired position at the treatment site, disconnecting the surgical needle from the strip;

(e) withdrawing the surgical needle from the tissue, leaving the strip disposed in the desired position within the patient'"'"'s body to administer the medical treatment to the treatment site;

(f) securing one end of the strip to a first object, said first object serving to anchor the strip in the desired position at the treatment site, preventing movement of the strip relative to the treatment site; and

(g) securing a second object to another end of said strip after the strip is disposed at the desired position, said second object including a sleeve that slips over the strip, said step of securing including one of the steps of;

crimping the sleeve of the second object about the strip, adhesively connecting the second object to the strip, connecting the second object to the strip with a threaded fastener, connecting the second object to the strip with a pin that extends through the sleeve and into the strip, and suturing the second object to the strip.