Directional-ionizing energy emitting implant

• US 20060106273A1
• Filed: 11/04/2005
• Published: 05/18/2006
• Est. Priority Date: 11/14/2000
• Status: Abandoned Application

• Current Assignee: Marc G. Apple
• Original Assignee: Marc G. Apple
• Inventors: Apple, Marc G.
• Application Number:
  US11/267,344
• Publication Number:
  US 20060106273A1
• Time in Patent Office: Days
• US Class Current: 600/3
• CPC Class Codes: A61B 17/68 Internal fixation devices , including fasteners and spinal fixators, even if a part thereof projects from the skin bone staples A61B17/0642
• CPC Class Codes: A61B 17/8066 for pelvic reconstruction
• CPC Class Codes: A61F 2/32 for the hip
• CPC Class Codes: A61F 2/38 for elbows or knees
• CPC Class Codes: A61F 2002/30082 radioactive
• CPC Class Codes: A61F 2002/30299 umbrella-shaped or mushroom-shaped
• CPC Class Codes: A61F 2002/30878 with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
• CPC Class Codes: A61F 2002/30932 for retarding or preventing ingrowth of bone tissue
• CPC Class Codes: A61F 2210/0095 radioactive
• CPC Class Codes: A61F 2230/0093 Umbrella-shaped, e.g. mushroom-shaped
• CPC Class Codes: A61K 51/1282 Devices used in vivo and carrying the radioactive therapeutic or diagnostic agent, therapeutic or in vivo diagnostic kits, stents
• CPC Class Codes: A61N 2005/1019 Sources therefor
• CPC Class Codes: A61N 5/1001 using radiation sources introduced into or applied onto the body; brachytherapy

Abstract

The directional-ionizing energy emitting implant is for attachment either to natural tissue or a prosthetic device, and delivers a prescribed dosage of energy to targeted tissue. The insert device includes an energy-source material within the insert device that delivers the prescribed dosage of energy to the targeted tissue, while minimizing exposure of nontargeted tissue. The targeted tissue has a known energy-response profile and is adjacent to the targeted tissue. The energy-source material in combination with the prosthetic device defines an actual energy-delivery distribution field. The energy-delivery distribution field has a configuration similar to the known energy-responsive profile of the targeted tissue. The prescribed dosage of energy is applied from energy-source material within the insert device and directed to the targeted tissue. The prescribed energy dosage is determined by using known characteristics of the energy-source material, and by the placement of the energy-source material relative to the targeted tissue. The implant system reduces any occurrence of heterotopic ossification caused by the implant, inhibits growth or migration of benign or malignant living cells, and minimizes or even eliminates infectious processes or delayed keloid or scar formation induced from surgical placement of a functional prosthesis or fixation device, in tissue within or about the device due to its targeted therapeutic energy emission effects.

Claims

1. An insert device for implantation and retention to organic tissue for delivering a prescribed dosage of ionizing energy to targeted tissue, the targeted tissue being adjacent to the organic tissue, the targeted tissue having a known ionizing energy-responsive profile, the insert device cooperating with a functioning or stabilizing prosthetic or fixation-type device, an ionizing energy-source material in combination with the prosthetic or fixation device defining an actual ionizing energy-delivery distribution field, the ionizing energy-source material being non-radioactive at time of implantation, the insert device including the ionizing energy-source material for delivery of the prescribed dosage of ionizing energy to the targeted tissue, the ionizing energy-delivery distribution field having a configuration similar to the known ionizing energy-responsive profile of the targeted tissue, the prescribed dosage of ionizing energy being applied from the insert device to the targeted tissue once the prosthetic or fixation device has been implanted, the ionizing energy-source material being a non-chemical agent, the prescribed ionizing energy dosage being determined by using known characteristics of the ionizing energy-source material and by controlling the placement of the ionizing energy-source material relative to the targeted tissue.

10. The insert device of claim 1, wherein the ionizing energy-source material is selected from the group consisting of yttrium, strontium, iridium, iodine, palladium, cesium, and technetium.

2. An insert device for implantation and retention to organic tissue for delivering a prescribed dosage of ionizing energy to targeted tissue, the targeted tissue having a known ionizing energy-responsive profile, the insert device being implanted into the organic tissue, the organic tissue being adjacent to the targeted tissue, the insert device including an ionizing energy-source material, the ionizing energy-source material within the insert device defining an actual ionizing energy-delivery distribution field, the ionizing energy-source material being non-radioactive at time of implantation, the ionizing energy-delivery distribution field having a configuration similar to the known ionizing energy-responsive profile of the targeted tissue, the ionizing energy-source material enabling the delivery of the prescribed dosage of ionizing energy to the targeted tissue, the prescribed dosage of ionizing energy being directed from the insert device to the targeted tissue once the insert device has been implanted into the organic tissue, the ionizing energy-source material being a non-chemical agent, the prescribed ionizing energy dosage being determined by using known characteristics of the ionizing energy-source material and by controlling the placement of the ionizing energy-source material relative to the targeted tissue.

11. The insert device of claim 2, wherein the ionizing energy-source material is selected from the group consisting of yttrium, strontium, iridium, iodine, palladium, cesium, and technetium.

3. A surgical procedure comprising:

determining a prescribed dosage of ionizing energy that is to be delivered from an insert device to targeted tissue, the targeted tissue having a known ionizing energy-responsive profile, the insert device being positioned within the prosthetic or fixation device, the insert device including an ionizing energy-source material, the ionizing energy-source material in combination with the prosthetic or fixation device defining an actual ionizing energy-delivery distribution field, the ionizing energy-delivery distribution field having a similar configuration to the known ionizing energy-responsive profile of the targeted tissue;

introducing the ionizing energy source material into the prosthetic or fixation device;

implanting the prosthetic or fixation device into organic tissue during a surgical procedure, the ionizing energy-source material being selected for delivering a predetermined dosage of the ionizing energy from the ionizing energy-source material to targeted tissue, the targeted tissue having a known ionizing energy-responsive profile;

activating the ionizing energy-source material once the insert device has been implanted into the organic tissue; and

delivering the prescribed dosage of ionizing energy from the ionizing energy-source material to the known ionizing energy-responsive profile of the targeted tissue.

12. The surgical procedure of claim 3, wherein the ionizing energy is selected from a group consisting of luminescent energy, hyperthermic energy, and photo-light energy.

4. A surgical procedure comprising:

determining a prescribed dosage of ionizing energy that is to be delivered from an insert device to targeted tissue, the targeted tissue having a known ionizing energy-responsive profile, the insert device being affixed to the prosthetic or fixation device, the insert device including an ionizing energy-source material, the ionizing energy-source material defining an actual ionizing energy-delivery distribution field, the ionizing energy-delivery distribution field having a similar configuration to the known ionizing energy-responsive profile of the targeted tissue;

introducing the ionizing energy-source material into the insert device;

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

activating the ionizing energy-source material once the insert device has been positioned into the organic tissue; and

delivering the prescribed dosage of ionizing energy from the ionizing energy-source material to the known ionizing energy-responsive profile of the targeted tissue.

13. The surgical procedure of claim 4, wherein the ionizing energy is selected from a group consisting of luminescent energy, hyperthermic energy, and photo-light energy.

5. An implant system for implantation and retention to organic tissue for delivering a dosage of ionizing energy to targeted tissue, the system including an insert member secured to a prosthetic or fixation device for implantation and retention to natural bone tissue and adjacent to the targeted tissue, the insert member having an ionizing energy-source material that is part of the prosthetic or fixation device that is implanted, the insert device including an ionizing energy-source material, the ionizing energy-source material being non-radioactive at time of implantation, the ionizing energy-source material being a non-chemical agent, the ionizing energy-source material enabling ionizing energy treatment to the targeted tissue, the ionizing energy treatment being applied from the insert member to the targeted tissue after implantation, whereby a predetermined dosage of prescribed ionizing energy to the targeted tissue is determined by using known characteristics of the ionizing energy-source material and by controlling the placement of the ionizing energy-source material relative to the targeted tissue.

14. The implant system of claim 5, wherein the ionizing energy-source material is selected from the group consisting of yttrium, strontium, iridium, iodine, palladium, cesium, and technetium.

6. A surgical method comprising:

introducing an insert member into a prosthetic or fixation device, the insert member including an ionizing energy-source material, the ionizing energy-source material being non-radioactive at time of implantation, the prosthetic or fixation device and ionizing energy-source material comprising a closed system for implantation within a patient, the prosthetic or fixation device having a function independent of ionizing energy delivery, the ionizing energy-source material being selected for delivering a predetermined dosage of the ionizing energy from the ionizing energy-source material to targeted tissue within a known ionizing energy-responsive profile, the known ionizing energy-responsive profile of the targeted tissue being proximate to the implant site;

securing the insert member to the prosthetic or fixation device, the ionizing energy-source material in the insert member in combination with the prosthetic or fixation device defining an actual ionizing energy delivery distribution field, the actual ionizing energy delivery distribution field having a similar configuration to the known ionizing energy-responsive profile of the targeted tissue; and

activating the ionizing energy-source material, thereby delivering the predetermined dosage of the ionizing energy from the ionizing energy-source material to targeted tissue within the known ionizing energy-responsive profile.

15. The surgical method of claim 6, wherein the ionizing energy-source material is selected from the group consisting of yttrium, strontium, iridium, iodine, palladium, cesium, and technetium.

7. A system for reducing infectious processes and excess scar formation within targeted tissue, the system comprising:

a prosthetic or fixation device for implantation and retention to natural bone tissue in proximity to the targeted tissue; and

an ionizing energy-source material disposed in proximity to the prosthetic or fixation device, the ionizing energy-source material being part of the prosthetic or fixation device that is implanted, the ionizing energy-source material being a non-chemical agent, the ionizing energy-source material being non-radioactive at time of implantation, any dispensation of the ionizing energy-source material to the target tissue being minimal, the ionizing energy-source material enabling ionizing energy treatment to reduce infection processes in the targeted tissue, the infectious processes being induced by surgical implantation of the prosthetic or fixation device, the ionizing energy treatment being applied from the prosthetic or fixation device after implantation;

whereby a predetermined dosage of prescribed ionizing energy to reduce the infection processes in the targeted tissue is determined by using known characteristics of the ionizing energy-source material and by controlling the placement of the ionizing energy-source material relative to the targeted tissue.

16. The system of claim 7, wherein the ionizing energy-source material is selected from the group consisting of yttrium, strontium, iridium, iodine, palladium, cesium, and technetium.

8. A prosthetic or fixation device for reducing infectious processes and excess scar formation within targeted tissue for implantation into organic tissue or a prosthetic or fixation device, the prosthetic or fixation device delivering a dosage of ionizing energy to targeted tissue, the prosthetic or fixation device having a function independent of ionizing energy delivery, the prosthetic or fixation device including an ionizing energy-source material, the implanted ionizing energy-source material enabling a predetermined dosage of ionizing energy treatment to be directed at the targeted tissue after implantation, the ionizing energy-source material being non-radioactive at time of implantation, the ionizing energy-source material reducing infectious processes within the targeted tissue caused by the implantation of the prosthetic or fixation device, the dosage of prescribed ionizing energy to the targeted tissue being pre-determined by applying known characteristics of the ionizing energy-source material and by controlling the placement of the ionizing energy-source material relative to the targeted tissue.

17. The prosthetic or fixation device of claim 8, wherein the ionizing energy-source material is selected from the group consisting of yttrium, strontium, iridium, iodine, palladium, cesium, and technetium.

9. A surgical method for reducing infectious processes and excess scar formation within targeted tissue, the method delivering prescribed ionizing energy to the targeted tissue, the method comprising:

introducing a prosthetic or fixation device including an ionizing energy-source material, the prosthetic or fixation device and ionizing energy-source material comprising a closed system for implantation within a patient, the prosthetic or fixation device having a function independent of ionizing energy delivery, the ionizing energy-source material being selected for delivering a predetermined dosage of the ionizing energy from the ionizing energy-source material to targeted tissue to reduce infectious processes within the targeted tissue, the targeted tissue having a known ionizing energy-responsive profile, the profile of the targeted tissue being proximate to the implant site; and

implanting the prosthetic or fixation device into organic tissue during a surgical procedure, the ionizing energy-source material being non-radioactive at time of implantation, the ionizing energy-source material in combination with the prosthetic or fixation device defining an actual ionizing energy delivery distribution field, the actual ionizing energy delivery distribution field having a similar configuration to the profile of the targeted tissue; and

activating the ionizing energy-source material, thereby reducing infectious processes within the targeted tissue by application of the pre-calibrated dose rate, depth dose, and total delivered dose of prescribed ionizing energy, the infectious processes being induced by surgical implantation of the prosthetic or fixation device.

18. A surgical method for reducing infectious processes and excess scar formation within targeted tissue, the method delivering prescribed ionizing energy to the targeted tissue, the method comprising;

introducing a prosthetic or fixation device including an ionizing energy-source material, the ionizing energy being selected from a group consisting of luminescent energy, hyperthermic energy, and photo-light energy, the prosthetic or fixation device and ionizing energy-source material comprising a closed system for implantation within a patient, the prosthetic or fixation device having a function independent of ionizing energy delivery, the ionizing energy-source material being selected for delivering a predetermined dosage of the ionizing energy from the ionizing energy-source material to targeted tissue to reduce infectious processes within the targeted tissue, the targeted tissue having a known ionizing energy-responsive profile, the profile of the targeted tissue being proximate to the implant site; and

implanting the prosthetic or fixation device into organic tissue during a surgical procedure, the ionizing energy-source material being non-radioactive at time of implantation, the ionizing energy-source material in combination with the prosthetic or fixation device defining an actual ionizing energy distribution field, the actual ionizing energy delivery distribution field having a similar configuration to the profile of the targeted tissue; and

activating the ionizing energy-source material, thereby reducing infectious processes within the targeted tissue by application of the pre-calibrated dose rate, depth dose, and total delivered dose of prescribed ionizing energy, the infectious processes being induced by surgical implantation of the prosthetic or fixation device.