Brachytherapy device and method

• US 20030233136A1
• Filed: 04/24/2003
• Published: 12/18/2003
• Est. Priority Date: 06/13/2001
• Status: Active Grant

• Current Assignee: John I. Williams, Marc G. Apple
• Original Assignee: John I. Williams, Marc G. Apple
• Inventors: Apple, Marc G., Williams, John I.
• Granted Patent: US 7,182,726 B2
• Time in Patent Office: Days
• US Class Current: 607/50
• CPC Class Codes: A61N 2005/1021 Radioactive fluid
• CPC Class Codes: A61N 5/1001 using radiation sources introduced into or applied onto the body; brachytherapy
• CPC Class Codes: A61N 5/1027 Interstitial radiation therapy
• CPC Class Codes: A61N 5/1029 Radioactive dressings
• CPC Class Codes: A61N 7/00 Ultrasound therapy lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 ; using ultrasound for introducing media into the body A61M37/0092

Abstract

The present invention provides a system and method of applying low dose, localized radiotherapy which is effective to reduce or eliminate the formation of post-operative scar tissue at surgical sites, such as an epidural site after spinal surgery. In an exemplary embodiment, a device is implantable before closing a surgical site as a barrier, the device being designed to deliver a desired therapeutic amount of energy to particular tissue. The device can be a barrier layer, seed containment unit, radiospike, or catheter. The energy may be provided by the material of the device itself, or may be provided by an external source, such as by circulating radioactive fluid through the device itself. Various embodiments include additional components of the device which deliver drug or chemical agents to targeted tissue and/or shield components to prevent dosage to non-targeted tissue.

Claims

1. An implant device for delivering a predetermined dosage of therapeutic energy treatment to reduce scarring, or inflammation proximate to a surgical site, the implant device comprising:

a. an energy emitting material to provide the therapeutic energy treatment to targeted tissue after a surgical procedure;

b. an energy-producing layer, the energy-producing layer being capable of pre-implantation shaping, the energy-producing layer being adaptable for surgical placement at a surgical site, the energy-producing layer providing desired treatment effects to the targeted tissue; and

c. an externally visible indicator, the externally visible indicator being part of the energy-producing layer, the externally visible indicator indicating proper placement of the implant device relative to the targeted tissue, the external visible indicators facilitating reproducible and predictable directional control and positional orientation of therapeutic energy treatment and dosage to the targeted tissue;

wherein the implant device is placed proximate to the targeted tissue during the surgical procedure, the implant device being integrated into a position relative to the targeted tissue to provide a beneficial three dimensional delivery of the therapeutic energy treatment to the targeted tissue.

2. The implant device of claim 1, whereby the implant device is provided in a pre-fixed shape.

3. The implant device of claim 1, whereby the implant device is provided as a single or multi-layer sheet to be custom cut prior to being implanted.

4. The implant device of claim 1, whereby the implant device provides a dural adhesion barrier when applied for spinal related procedures to enhance dural adhesion control.

5. The implant device of claim 1, further comprising energy-opaque markers positioned and fashioned that provide a visible confirmation implant device placement subsequent to the surgical procedure.

6. The implant device of claim 1, further comprising an attenuating barrier components to facilitate a precise directional focusing of therapeutic energy to the targeted tissue while shielding adjacent non-targeted tissue from exposure to the therapeutic energy.

7. The implant device of claim 1, further comprising at least one energy-attenuating barrier, the energy-attenuating barrier including at least one contoured energy-attenuating layer, the energy-attenuating barrier being activated at a time subsequent to the surgical placement of the implant device.

8. The implant device of claim 1, whereby the energy is selected from the group consisting of ionizing radiation, high-frequency ultrasound, hyperthermic emissions, magnetic fields, and their combination.

10. The implant device of claim 1, whereby the energy is selected from the group consisting of ionizing radiation, high-frequency ultrasound, hyperthermic emissions, magnetic fields, and their combination.

9. An implant device for delivering a predetermined dosage of therapeutic energy treatment to reduce scarring proximate to a surgical site, the implant device comprising:

a. an energy emitting material disposed relative to the implant device to provide the therapeutic energy treatment to targeted tissue after a surgical procedure;

b. an energy-producing layer, the energy-producing layer being capable of pre-implantation shaping, the energy-producing layer being adaptable for surgical placement at a surgical site, the energy-producing layer providing desired treatment effects to the targeted tissue; and

c. attenuating barrier components to focus in a precise manner the therapeutic energy to the targeted tissue while shielding adjacent non-targeted tissue from exposure;

wherein the implant device is placed adjacent to the targeted tissue during the surgical procedure, the implant device being integrated into a position relative to the targeted tissue to provide a beneficial three dimensional delivery of the therapeutic energy treatment to the targeted tissue.

11. An implant device for delivering a predetermined dosage of therapeutic energy treatment to reduce scarring epidural scarring resulting from spinal surgery, the implant device comprising:

a. an energy emitting material disposed relative to the implant device to provide the therapeutic energy treatment to tissue proximate to the spinal cord after surgery;

b. an energy-producing layer, the energy-producing layer being capable of pre-implantation shaping, the energy-producing layer being adaptable for placement at a surgical site, the energy-producing layer providing desired treatment effects to the tissue proximate to the spinal cord; and

c. an externally visible indicator, the externally visible indicator being part of the energy-producing layer, the externally visible indicator indicating proper placement of the implant device relative to the targeted tissue, the external visible indicators facilitating reproducible and predictable directional control of therapeutic energy treatment and dosage to the targeted tissue;

wherein the implant device is placed proximate to the spinal cord during the surgical procedure, the implant device being integrated into a position relative to the spinal cord to provide a beneficial three dimensional delivery of the therapeutic energy treatment to the tissue proximate to the spinal cord.

12. The implant device of claim 11, whereby the energy is selected from the group consisting of ionizing radiation, high-frequency ultrasound, hyperthermic emissions, magnetic fields, and their combination.

13. An implant device for delivering a predetermined dosage of therapeutic energy treatment to reduce scarring epidural scarring resulting from spinal surgery, the implant device comprising:

a. an energy emitting material disposed relative to the implant device to provide the therapeutic energy treatment to tissue proximate to the spinal cord after surgery;

b. an energy-producing layer, the energy-producing layer being capable of pre-implantation shaping, the energy-producing layer being adaptable for placement at a surgical site, the energy-producing layer providing desired treatment effects to the tissue proximate to the spinal cord; and

c. attenuating barrier components to focus in a precise manner the therapeutic energy to the targeted tissue while shielding adjacent non-targeted tissue from exposure;

wherein the implant device is placed proximate to the spinal cord during the surgical procedure, the implant device being integrated into a position relative to the spinal cord to provide a beneficial three dimensional delivery of the therapeutic energy treatment to the tissue proximate to the spinal cord.

14. The implant device of claim 13, whereby the energy is selected from the group consisting of ionizing radiation, high-frequency ultrasound, hyperthermic emissions, magnetic fields, and their combination.

15. An implant device for delivering a predetermined dosage of energy treatment to reduce chronic back pain or scarring or inflammation, the implant device comprising:

a. an energy emitting material disposed relative to the implant device to provide the therapeutic energy treatment to tissue proximate to the spinal cord after a surgical procedure;

b. an energy-producing layer, the energy-producing layer being capable of pre-implantation shaping, the energy-producing layer being adaptable for surgical placement at a surgical site, the energy-producing layer providing desired treatment effects to the tissue proximate to the spinal cord;

c. a layer having magnetic field properties, the magnetic field layer directionally shifting particle radiation toward the targeted tissue proximate to the spinal cord or repelling similar charged particle energy away from the targeted tissue proximate to the spinal cord; and

d. attenuating barrier components to facilitate a precise directional focusing of therapeutic energy to the targeted tissue while shielding adjacent non-targeted tissue from unnecessary exposure;

wherein the implant device is placed proximate to the spinal cord during the surgical procedure, the implant device being integrated into a position relative to the spinal cord to provide a beneficial three dimensional delivery of the therapeutic energy treatment to the tissue proximate to the spinal cord.

16. An implant device for delivering a predetermined dosage of therapeutic energy treatment to reduce scarring proximate to a surgical site, the implant device comprising:

a. an energy emitting material disposed relative to the implant device to provide the therapeutic energy treatment to targeted tissue;

b. a plurality of energy-producing layers for providing desired treatment to surrounding tissue, the energy-producing layer being capable of pre-implantation shaping, the energy-producing layer being adaptable for surgical placement at the surgical site, the energy-producing layer providing desired treatment effects to the targeted tissue, at least one of the plurality of layers being time released and dissolvable layer, the time-released dissolvable energy-producing layer being in alignment with the energy emitting material; and

c. externally visible indicators, the externally visible indicators being disposed as part of the energy-producing layer, the externally visible indicators indicating proper placement of the implant device relative to the targeted tissue, the external visible indicators facilitating reproducible and predictable directional control of therapeutic energy treatment and dosage to the targeted tissue;

wherein the implant device is placed adjacent to the targeted tissue during a surgical procedure, the implant device being integrated into a position relative to the targeted tissue to provide a beneficial three dimensional delivery of the therapeutic energy treatment to the targeted tissue.

18. The implant device of claim 16, whereby at least one of the plurality of layers has energy attenuating properties for localizing energy opaque elements to demarcate orientation for confirmation of radiation dose delivery.

19. The implant device of claim 16, whereby the implant device enables supplemental postoperative treatment of the surgical site.

20. The implant device of claim 16, whereby at least one of the plurality of layers includes surface impregnation, the surface impregnation being a chemical agent selected for a desired treatment effect.

21. The implant device of claim 16, whereby the energy is selected from the group consisting of ionizing radiation, high-frequency ultrasound, hyperthermic emissions, magnetic fields, and their combination.

22. A system for delivering a predetermined dosage of radiotherapy treatment to targeted tissue, the system comprising a fluid delivery system including a fluid delivery pump, an inlet portion and an outlet portion, a connector, and a lumen array, the inlet portion being connectable to the fluid delivery pump, the connector enabling detachable connection of the inlet portion to the lumen array, the lumen array being disposed between the inlet portion and the outlet portion, the fluid-delivery system being connectable to an external source of radioactive fluid, the fluid being a gas, liquid or gel, the radioactive fluid providing the radiotherapy treatment to targeted tissue after a surgical procedure, the radioactive fluid being delivered from an external source into the inlet portion through the lumen array and exiting through the outlet portion, the lumen array being implanted proximate to the targeted tissue during a surgical procedure, the lumen array being integrated into a position proximate to the targeted tissue during an implant procedure to deliver a predetermined radiotherapy dose of the radiotherapy treatment to the targeted tissue.

23. The system of claim 22, whereby the lumen array is made of a material that is biodegradable once the radiotherapy dose is delivered.

24. The system of claim 22, whereby the lumen array is extracted after the radiotherapy dose is administered.

25. The system of claim 22, whereby the lumen array is embedded in a chemical agent.

26. The system of claim 22, whereby the lumen array is embedded in an attenuation barrier.

27. The system of claim 22, whereby the lumen array is embedded in a radionuclide component.

28. The system of claim 22, whereby the lumen array includes an externally visible indicator, the externally visible indicator being disposed as part of a radiotherapy layer, the externally visible indicator indicating proper placement of the implant device relative to the targeted tissue, the external visible indicator facilitating reproducible and predictable directional control of radiotherapy treatment and dosage to the targeted tissue.

29. The system of claim 22, whereby the lumen array includes a radiotherapy layer, the radiotherapy layer containing a radionuclide material, the radiotherapy layer being adaptable for surgical placement at a surgical site, the radiotherapy layer providing desired treatment effects to the targeted tissue.

30. The system of claim 22, whereby at least one of the plurality of layers being a surface impregnation, the surface impregnation being a chemical agent selected for a desired treatment effect.

31. A system for applying localized treatment of ultrasonic wave energy to reduce the formation of post-operative scar tissue at a surgical site, the system comprising an ultrasonic generating source and an ultrasonic transducer, ultrasonic wave energy being transmitted from the ultrasonic generating source to the ultrasonic transducer, the ultrasonic transducer being implanted under surface tissue proximate to targeted tissue, the ultrasonic transducer being actuatable to deliver ultrasonic wave energy after a surgical procedure, the ultrasonic transducer being integrated into a position proximate to the targeted tissue during the surgical procedure to deliver a predetermined dose of the ultrasonic wave energy to the targeted tissue.

32. The system of claim 31, whereby the transducer includes an externally visible indicator, the externally visible indicator being disposed as part of the radiotherapy layer, the externally visible indicator indicating proper placement of the implant device relative to the targeted tissue, the external visible indicator facilitating reproducible and predictable directional control of radiotherapy treatment and dosage to the targeted tissue.

33. The system of claim 31, whereby the transducer includes a radiotherapy layer, the radiotherapy layer containing a radionuclide material, the radiotherapy layer being adaptable for surgical placement at a surgical site, the radiotherapy layer providing desired treatment effects to the targeted tissue.

34. The system of claim 31, whereby at least one of the plurality of layers being a surface impregnation, the surface impregnation being a chemical agent selected for a desired treatment effect.

35. A radio spike device for delivering a predetermined dosage of radiotherapy treatment to targeted tissue, the targeted tissue being proximate to a surgical site to reduce scarring proximate to the surgical site, the radio spike device comprising a module and an attachment portion, the module having radio nuclide material disposed therein, the attachment portion retaining the radio spike device securely to tissue, any dispensation of the radionuclide to the target tissue being minimal, the radionuclide enabling radio-treatment to the targeted tissue, the radio-treatment being applied from the radio-spike device to the targeted tissue after the radio spike device has been implanted during surgery, a predetermined dosage of radio-therapy for the targeted tissue being determined by using known physics characteristics of the radio-source material and by controlling the placement of the radio-source material relative to the targeted tissue.

36. The radio spike device of claim 35, whereby the radio spike device includes an externally visible indicator, the externally visible indicator enabling proper placement of the radio spike device relative to the targeted tissue, the external visible indicator facilitating reproducible and predictable directional control of radiotherapy treatment and dosage to the targeted tissue.

37. A radio anchor device for delivering a predetermined dosage of radiotherapy treatment to targeted tissue, the targeted tissue being proximate to a surgical site to reduce scarring proximate to the surgical site, the radio anchor device including at least one energy containment channel, the energy containment channel containing a radionuclide material, radio anchor device being attachable to nontargeted tissue, the nontargeted tissue being proximate to targeted tissue to be treated, the radio anchor including a radio nuclide material, any dispensation of the radio-source material to the target tissue being minimal, the radio-source material enabling radio-treatment to the targeted tissue, the radio-treatment being applied from the radio-anchor device to the targeted tissue after the radio anchor device has been implanted during surgery, a predetermined dosage of radio-therapy for the targeted tissue being determined by using known physics characteristics of the radio-source material and by controlling the placement of the radio-source material relative to the targeted tissue.

38. The radio anchor device of claim 37, whereby the radio anchor device includes an externally visible indicator, the externally visible indicator enabling proper placement of the radio anchor device relative to the targeted tissue, the external visible indicator facilitating reproducible and predictable directional control of radiotherapy treatment and dosage to the targeted tissue.

39. A procedure for delivering a predetermined dosage of therapeutic energy treatment to reduce scarring proximate to a surgical site, the procedure comprising:

a. determining a prescribed dosage of energy emitting material for delivery from an implant device to targeted tissue, the targeted tissue having a known profile, the implant device being positioned proximate to the targeted tissue during a surgical procedure, the radio-source material defining an actual radio-delivery distribution field, the radio-delivery distribution field having a similar configuration to the known profile of the targeted tissue;

b. introducing the radio-source material into the implant device;

c. positioning the implant device into organic tissue during the surgical procedure, the radio-source material being selected for delivering a predetermined dosage of the energy from the radio-source material to targeted tissue, the targeted tissue having a known profile;

d. activating the energy emitting material; and

e. delivering the prescribed dosage of energy from the energy emitting material to the known profile of the targeted tissue.

40. The procedure of claim 39, whereby the energy is selected from the group consisting of ionizing radiation, high-frequency ultrasound, hyperthermic emissions, magnetic fields, and their combination.