System and method for delivering a therapeutic agent for bone disease

• US 20050131268A1
• 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:
  US10/990,285
• Publication Number:
  US 20050131268A1
• 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 17/7258 with laterally expanding parts, e.g. for gripping the bone
• 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 17/744 the longitudinal elements coupled to an intramedullary nail
• CPC Class Codes: A61B 17/8855 inflatable, e.g. kyphoplasty balloons
• 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 2/44 : for the spine, e.g. vertebrae, spinal discs
• CPC Class Codes: A61F 2/441 : made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
• 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 2/4611 : of spinal prostheses
• 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 2025/1072 : 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, an expandable structure has at least one lumen configured to receive a radiation source, and is configured for insertion into a skeletal support structure. The expandable structure is further configured to create a void within the skeletal support structure. Furthermore, the expandable structure comprises at least one lumen configured to contain a radiation source.

Claims

1. An apparatus comprising an expandable structure having at least one lumen configured to receive a radiation source, the expandable structure configured for insertion into a skeletal support structure, and further configured to create a void within the skeletal support structure and comprising at least one lumen configured to contain a radiation source.

2. The apparatus of claim 1, wherein the expandable structure is configured to be coupled to an elongated member for inserting the expandable structure into the skeletal support structure.

3. The apparatus of claim 2, wherein the at least one lumen is disposed substantially parallel to the elongated member.

4. The apparatus of claim 2, wherein the elongated member comprises a first elongated member and a second elongated member, wherein the second elongated member is coupled to the expandable structure, and the first elongated member is configured to receive the expandable structure and the second elongated member.

5. The apparatus of claim 4, further comprising a means for penetrating a skeletal support structure configured to receive the first elongated member.

6. The apparatus of claim 1, wherein the expandable structure includes a primary lumen, and wherein the at least one lumen includes a secondary lumen.

7. The apparatus of claim 1, wherein the at least one lumen is configured to be in fluid communication with a lumen in the elongated member.

8. The apparatus of claim 1, wherein the expandable structure comprises:

a first layer, and

a second layer configured to receive a radiation source between the first layer and the second layer.

9. The apparatus of claim 1, wherein the expandable structure is configured to be inserted into a void in an unexpanded configuration, expanded in the void to an expanded configuration, and unexpanded after expansion.

10. The apparatus of claim 1, wherein the expandable structure is comprised of an expandable material having an interior lumen, the expandable material being configured to expand to a first shape, and to reversibly expand to a second shape.

11. The apparatus of claim 1, wherein the expandable structure is comprised of a folding geometry structure configured to reversibly expand to a desired shape.

12. The apparatus of claim 1, wherein the expandable structure is configured to expand a void within an interior volume of a vertebral body.

13. The apparatus of claim 1, further comprising an insertion sleeve configured to substantially surround the expandable structure.

14. The apparatus of claim 1, wherein two or more lumens are disposed circumferentially about the expandable structure.

15. The apparatus of claim 1, wherein the expandable structure comprises:

a first lumen; and

a second lumen, wherein the first lumen is configured for expansion of the expandable structure, and the second lumen is configured for containing a radiation source.

16. The apparatus of claim 15, wherein the first lumen and second lumen are configured to receive a radiopaque substance therebetween.

17. The apparatus of claim 1, wherein the expandable structure is comprised of one or more lumens having walls, the walls having been co-manufactured with the radiation source.

18. The apparatus of claim 1, wherein the expandable structure is comprised of one or more lumens having walls, the walls having been co-manufactured with a radiopacifier.

19. The apparatus of claim 1, further including the radiation source, and wherein the at least one lumen is configured to contain the radiation source.

20. The apparatus of claim 1, wherein the expandable structure comprises a distal end, and the at least one lumen comprises a catheter having an opening substantially near the distal end.

21. The apparatus of claim 1, wherein the radiation source is comprised of a radionuclide.

22. The apparatus of claim 21, wherein the radionuclide is in a form selected from the group consisting of liquid, wire, seed, needle, pellet, particle and microsphere.

23. The apparatus of claim 21, 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.

24. A method comprising:

inserting into a skeletal support structure an expandable structure configured to be coupled to an elongated member, the expandable structure comprising at least one lumen configured to receive a radiation source;

expanding the expandable structure; and

transporting the radiation source through the at least one lumen into the skeletal support structure.

25. The method of claim 24, further comprising:

depositing a supportive material in the skeletal support structure.

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.