System and method for delivering a therapeutic agent for bone disease

• US 20050131269A1
• Filed: 11/15/2004
• Published: 06/16/2005
• Est. Priority Date: 06/07/1995
• Status: Abandoned Application

• Current Assignee: Kyphon SARL (Medtronic Plc)
• Original Assignee: Kyphon SARL (Medtronic Plc)
• Inventors: Talmadge, Karen D.
• Application Number:
  US10/990,291
• Publication Number:
  US 20050131269A1
• Time in Patent Office: Days
• US Class Current: 600/3
• CPC Class Codes: A61B 10/025 for taking bone, bone marrow or cartilage samples
• 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 17/025 Joint distractors
• CPC Class Codes: A61B 17/7061 for stabilising vertebrae or discs by improving the condition of their tissues, e.g. using implanted medication or fluid exchange intraosseous injection devices A61B17/3472
• CPC Class Codes: A61B 17/7097 Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants disc prostheses made of inflatable chambers or pockets filled with fluid A61F2/441; replacing the nucleus pulposus A61F2002/444
• CPC Class Codes: A61B 17/74 Devices for the head or neck or trochanter of the femur trochanteric devices connected to the proximal part of an endoprosthetic femoral shaft A61F2/30739; endoprosthetic internal fixation devices for the head or neck of the femur A61F2/3601
• CPC Class Codes: A61B 17/8805 for introducing fluid filler into bone or extracting it A61B17/7097, A61B17/8833 take precedence
• CPC Class Codes: A61B 17/8855 inflatable, e.g. kyphoplasty balloons
• CPC Class Codes: A61B 17/8858 laterally or radially expansible inflatable A61B17/8855
• CPC Class Codes: A61B 2010/0258 Marrow samples
• CPC Class Codes: A61B 2017/00539 hydraulically
• CPC Class Codes: A61B 2017/00544 pneumatically
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/0256 for the spine
• CPC Class Codes: A61B 2050/0065 Peelable cover
• CPC Class Codes: A61B 2050/3015 transparent
• CPC Class Codes: A61B 50/33 Trays
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61B 90/94 coded with symbols, e.g. text
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/2846 : Support means for bone substitute or for bone graft implants, e.g. membranes or plates for covering bone defects nets or sleeves applied to surface of endoprostheses A61F2/30907; bone plates A61B17/80; bone regeneration in dental surgery A61C8/0006
• CPC Class Codes: A61F 2/3601 : for replacing only the epiphyseal or metaphyseal parts of the femur, e.g. endoprosthetic femoral heads or necks directly fixed to the natural femur by internal fixation devices non-prosthetic internal fixation devices for the femoral head or neck A61B17/74
• CPC Class Codes: A61F 2/389 : Tibial components A61F2/3868 takes precedence
• CPC Class Codes: A61F 2/4601 : for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
• CPC Class Codes: A61F 2002/2817 : Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
• CPC Class Codes: A61F 2002/2825 : Femur
• CPC Class Codes: A61F 2002/2828 : Femoral head
• CPC Class Codes: A61F 2002/2832 : Femoral neck
• CPC Class Codes: A61F 2002/2835 : Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
• CPC Class Codes: A61F 2002/2853 : Humerus
• CPC Class Codes: A61F 2002/2871 : Radius
• CPC Class Codes: A61F 2002/2892 : Tibia
• CPC Class Codes: A61F 2002/30113 : circular
• CPC Class Codes: A61F 2002/30115 : circular-O-shaped
• CPC Class Codes: A61F 2002/30125 : elliptical or oval
• CPC Class Codes: A61F 2002/30131 : horseshoe- or crescent- or C-shaped or U-shaped
• CPC Class Codes: A61F 2002/30133 : kidney-shaped or bean-shaped
• CPC Class Codes: A61F 2002/302 : toroidal, e.g. rings
• CPC Class Codes: A61F 2002/30225 : Flat cylinders, i.e. discs
• CPC Class Codes: A61F 2002/30228 : Cylinders of elliptical or oval basis
• CPC Class Codes: A61F 2002/30242 : spherical
• CPC Class Codes: A61F 2002/30245 : Partial spheres
• CPC Class Codes: A61F 2002/30253 : ellipsoidal or ovoid
• CPC Class Codes: A61F 2002/30285 : rugby-ball-shaped
• CPC Class Codes: A61F 2002/30288 : bottle-shaped
• CPC Class Codes: A61F 2002/30308 : banana-shaped
• CPC Class Codes: A61F 2002/30313 : pear-shaped
• CPC Class Codes: A61F 2002/30448 : using adhesives
• CPC Class Codes: A61F 2002/30462 : retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2002/30581 : having a pocket filled with fluid, e.g. liquid
• CPC Class Codes: A61F 2002/30586 : having two or more inflatable pockets or chambers
• CPC Class Codes: A61F 2002/30599 : stackable
• CPC Class Codes: A61F 2002/30677 : Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30686 : Devices for removing particulate debris from prosthetic joints
• CPC Class Codes: A61F 2002/30909 : Nets
• CPC Class Codes: A61F 2002/3611 : Heads or epiphyseal parts of femur
• CPC Class Codes: A61F 2002/3625 : Necks
• CPC Class Codes: A61F 2002/4062 : Proximal or metaphyseal parts of shafts
• CPC Class Codes: A61F 2002/4217 : Calcaneum or calcaneus or heel bone
• CPC Class Codes: A61F 2002/4627 : with linear motion along or rotating motion about the instrument axis or the implantation direction, e.g. telescopic, along a guiding rod, screwing inside the instrument
• CPC Class Codes: A61F 2002/4635 : using minimally invasive surgery
• CPC Class Codes: A61F 2002/4685 : by means of vacuum
• CPC Class Codes: A61F 2220/005 : using adhesives
• CPC Class Codes: A61F 2220/0075 : sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0006 : circular
• CPC Class Codes: A61F 2230/0008 : elliptical or oval
• CPC Class Codes: A61F 2230/0013 : Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0015 : Kidney-shaped, e.g. bean-shaped
• CPC Class Codes: A61F 2230/0063 : Three-dimensional shapes
• CPC Class Codes: A61F 2230/0065 : toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2230/0071 : spherical
• CPC Class Codes: A61F 2230/0076 : ellipsoidal or ovoid
• CPC Class Codes: A61F 2250/0063 : Nested prosthetic parts
• CPC Class Codes: A61F 2310/00293 : containing a phosphorus-containing compound, e.g. apatite
• CPC Class Codes: A61F 2310/00353 : Bone cement, e.g. polymethylmethacrylate or PMMA
• CPC Class Codes: A61F 2310/0097 : Coating or prosthesis-covering structure made of pharmaceutical products, e.g. antibiotics
• CPC Class Codes: A61M 2025/105 : having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1072 : having balloons with two or more compartments
• CPC Class Codes: A61M 2210/02 : Bones
• CPC Class Codes: A61M 2210/1003 : Spinal column
• CPC Class Codes: A61M 25/10 : Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1002 : characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1011 : Multiple balloon catheters

Abstract

Various systems, and methods are provided for transporting a therapeutic agent to the interior of a skeletal support structure. In one implementation, a first elongated member, a second elongated member and an expandable structure provide for non-axial access to the interior of a skeletal support structure. The second elongated member is configured to transport a radiation source through a lumen in the first elongated member to the interior of the skeletal support structure.

Claims

1. An apparatus comprising:

a first elongated member having a lumen configured to provide non-axial access to an interior of a skeletal support structure; and

a second elongated member configured to transport a therapeutic agent through the lumen to the interior of the skeletal support structure.

2. The apparatus of claim 1, wherein the therapeutic agent is a radiation source.

3. The apparatus of claim 1, wherein the therapeutic agent is a chemotherapeutic agent.

4. The apparatus of claim 1, wherein the skeletal support structure is bone.

5. The apparatus of claim 1, wherein the skeletal support structure is selected from the list consisting of cartilage and ossified derivatives thereof, membrane bone and cartilage bone.

6. The apparatus of claim 1, wherein the skeletal support structure is a vertebral body.

7. The apparatus of claim 1, wherein the second elongated member has a distal end that includes an expandable structure configured to expand a void within the skeletal support structure.

8. The apparatus of claim 7, wherein the expandable structure includes a radiation source.

9. The apparatus of claim 7, further comprising an expandable structure coupled to the second elongated member and configured to deliver a radiation dose to the interior of the skeletal support structure.

10. The apparatus of claim 9, wherein the expandable structure comprises at least one lumen configured to receive a radiation source.

11. The apparatus of claim 9, wherein the expandable structure comprises a first layer and a second layer configured to receive a radiation source therebetween.

12. The apparatus of claim 11, wherein the first layer and second layer are configured to receive a radiopaque substance therebetween.

13. The apparatus of claim 11, wherein the first layer and/or the second layer are comprised of a radiopacifier.

14. The apparatus of claim 1, wherein the second elongated member includes a distal end configured to be remotely visualized while inside the interior of the skeletal support structure.

15. The apparatus of claim 1, wherein the first elongated member includes a means for penetrating a skeletal support structure.

16. The apparatus of claim 1, wherein one of the first elongated member and the second elongated member is further configured to position the radioactive source at a predetermined location.

17. The apparatus of claim 14, wherein at least one of the first elongated member and the second elongated member include markings configured to provide positional information.

18. The apparatus of claim 1, further comprising a radiation source configured to provide a dose of radiation substantially localized within the interior of the skeletal support structure.

19. The apparatus of claim 18, wherein the radiation source is comprised of a radionuclide.

20. The apparatus of claim 19, wherein the radionuclide is in a form selected from the group consisting of liquid, seed, needle, pellet, particle and microsphere.

21. The apparatus of claim 19, wherein the radionuclide is selected from the group consisting of Au-198, Co-60, Cs-137, I-125, I-135, Ir-192, P-32, Pd-103, Ra-226, Rh-106, Ru-106, Sr-90 and Y-90.

22. The apparatus of claim 1, further comprising a radiation shield configured to shield the radiation source.

23. A method comprising:

inserting non-axially, into an interior of a skeletal support structure, a first elongated member having a lumen that defines an access path into the interior of the skeletal support structure;

inserting, into the lumen, a second elongated member configured to transport a radiation source to the interior of the skeletal support structure; and

transporting the radiation source through the lumen into the interior of the skeletal support structure.

24. The method of claim 23, further comprising expanding at least a portion of the second elongated member to expand a void in the interior of the skeletal support structure.

25. The method of claim 24, further comprising:

depositing a supportive material in the void.

26. The method of claim 25, wherein the supportive material is selected from the group consisting of bone cement, human bone autograft, human bone allograft, calcium sulfate, calcium phosphate and hydroxyapatite.

27. The method of claim 25, wherein the supportive material includes a chemotherapeutic agent.

28. The method of claim 25, wherein the supportive material includes a radioactive agent.

29. The method of claim 23, wherein transporting the radiation source comprises placing the radiation source at one or more dwell positions.

30. The method of claim 29, further comprising determining the one or more dwell positions that provide a dose of radiation substantially localized within the interior of the skeletal support structure.

31. The method of claim 23, wherein inserting the first elongated device comprises inserting the device into an interior volume of a vertebral body through a pedicle of the vertebral body.