WO2006053312A1 - System and method for delivering a therapeutic agent for bone disease - Google Patents
System and method for delivering a therapeutic agent for bone disease Download PDFInfo
- Publication number
- WO2006053312A1 WO2006053312A1 PCT/US2005/041257 US2005041257W WO2006053312A1 WO 2006053312 A1 WO2006053312 A1 WO 2006053312A1 US 2005041257 W US2005041257 W US 2005041257W WO 2006053312 A1 WO2006053312 A1 WO 2006053312A1
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- WIPO (PCT)
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- expandable
- radiation source
- lumen
- support structure
- skeletal support
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/1072—Balloon catheters with special features or adapted for special applications having balloons with two or more compartments
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2210/00—Anatomical parts of the body
- A61M2210/02—Bones
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2210/00—Anatomical parts of the body
- A61M2210/10—Trunk
- A61M2210/1003—Spinal column
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1011—Multiple balloon catheters
Definitions
- This invention relates to therapy for bone disease.
- this invention relates to systems and methods for accessing bone to deposit a therapeutic agent.
- Radiation therapy and chemotherapy are commonly used to treat cancerous conditions, such as spinal metastases. Radiation therapy can be administered in any of a number of ways, including external-beam radiation, stereotactic radiosurgery, and permanent or temporary interstitial brachytherapy.
- a first elongated member has a lumen configured to provide non-axial access to an interior of a skeletal support structure.
- a second elongated member is configured to transport a therapeutic agent through the lumen to the interior of the skeletal support structure.
- FIG. 1 shows an apparatus including a first elongated member and a second elongated member having an expandable structure.
- FIG 2 A shows an expandable structure connected to a second elongated member in an unexpanded configuration.
- FIG 2B shows an expandable structure connected to a second elongated member in an expanded configuration.
- FIG 2C is cross-sectional end view of the expandable structure of FIG.
- FIG 2D is a cross-sectional end view of the second elongated member of
- FIG 2A is a diagrammatic representation of FIG.
- FIG. 3 shows an apparatus including a first elongated member and a second elongated member having an expandable structure, disposed within a vertebral body.
- FIG 4A shows an expandable structure including a primary lumen and a number of secondary lumens, in an unexpanded configuration.
- FIG 4B shows an expandable structure of FIG 4 A in an expanded configuration.
- FIG. 4C is cross-sectional end view of the expandable structure of FIG 4B in an expanded configuration.
- FIG. 4D is a cross-sectional end view of the second elongated member of
- FIG 4A is a diagrammatic representation of FIG.
- FIG. 1 shows an apparatus 100 for providing a radiation source to the interior of a skeletal support structure.
- the apparatus 100 includes a first elongated member 101 having a lumen 104, wherein the first elongated member 101 is configured to provide non-axial access to the interior of the skeletal support structure.
- the first elongated member 101 can be configured, for example, as a cannula, catheter, needle, trocar or other suitable access device.
- the apparatus 100 includes a second elongated member 102 configured to transport a therapeutic agent through the lumen 104 of the first elongated member 101 to the interior of the skeletal support structure.
- the apparatus 100 includes an expandable structure 103 configured for insertion into a skeletal support structure, wherein the expandable structure 103 is configured to create/expand a void within the skeletal support structure.
- the therapeutic agent transported to the interior of the skeletal support structure can include but is not limited to, for example a chemotherapeutic agent, a radiation source or combinations thereof.
- the skeletal support structure accessed using the apparatus 100 can include, but is not limited to, for example, bone, cartilage and ossified derivatives thereof, membrane bone and cartilage bone.
- the first elongated member 101 facilitates access to a skeletal support structure consisting of a vertebral body 301.
- the interior volume 304 typically containing cancellous bone 305, is accessed via the first elongated member 101 through the pedicle 303 of the vertebral body 301.
- Access to the interior of the vertebral body 301 can be accomplished via the side walls of the vertebral body 301, for example, using an extrapedicular, posterolateral, lateral, or anterior approach; or also via the vertebral body 301 endplates.
- the second elongated member 102 has a distal end that includes an expandable structure 103 configured to create a void 302 within the skeletal support structure (e.g., see void 302 in FIG. 3).
- expandable refers to a property of the structure that includes elastic, non-elastic, and partially elastic/non-elastic expansion.
- the expandable structure can be made from a deformable plastic or metal material.
- create a void is meant to include both expanding an existing void in a skeletal support structure in addition to expanding the interior of a skeletal support structure to produce a void.
- a skeletal support structure accessed with the apparatus 100 can comprise a void prior to being accessed or upon being accessed. It is further contemplated that such a prior existing or contemporaneously formed void can be further expanded using the above-described expandable structure 103.
- the expandable structure 103 is coupled to the second elongated member 102 and can be configured to deliver a radiation dose to the interior of the skeletal support structure.
- the expandable structure 103 is comprised of a first expandable structure 200 and a second expandable structure 201.
- the first and second expandable structures 200 and 201 are configured to define a primary lumen 202 and a secondary lumen 203 (see FIGS. 2A-C).
- suitable primary and secondary lumens 202 and 203 include but are not limited to, inner open spaces or cavities within a tube, sleeve, pocket, pouch, sac, bag, or vessel.
- the primary and secondary lumens 202 and 203 extend into and span substantially the length of the second elongated member 102.
- a radiation source can be received between the first and second expandable structures 200 and 201 in the secondary lumen 203. Expansion of the expandable structure 103 can be controlled by the addition of a substance (e.g., a fluid) to, for example, the primary lumen 202.
- a substance e.g., a fluid
- the first expandable structure 200 and second expandable structure 201 are configured to achieve a correlated expanded state.
- correlated expanded state is meant to describe an expansion of the first and second expandable structures 200 and 201, synchronously or asynchronously, at a same or different rates or any suitable manner to achieve a fixed relationship or a variable one depending on the elasticity or other properties of the expandable structures 200 and 201.
- the first expandable structure 200 can be expanded to a first size while coincidentally the second expandable structure 201 can be expanded to substantially the same first size.
- the first expandable structure 200 can be expanded to a first size while coincidentally the second expandable structure 201 can be expanded to a second size.
- the first and second expandable structures 200 and 201 are configured to unexpand.
- the unexpanded configuration can facilitate, for example, removal of part or all of the apparatus 100 from a skeletal support structure.
- the second elongated member 102 is configured at the distal end to be remotely visualized (e.g., using fluoroscopy, X-ray, MRI, CT scan, or computer-aided imaging) while the distal end is inside the interior of the skeletal support structure.
- Such a configuration can include suitable marking means for remote visualization disposed substantially near the distal end of the second elongated member 102 (not shown).
- such a configuration can be accomplished using one or more radiopaque marker bands.
- the expandable structure 103 can be comprised of one or more radiopacifer.
- radiopacifiers include but are not limited to, iodine (such as CONRA Y® available from Mallinckrodt), gadoliminum, tungsten, tantalum, barium, strontium. It is contemplated that a radiopacifier or a radiopaque substance can be disposed within the primary lumen 202, and/or the secondary lumen 203 of the expandable structure 103. Alternatively, the first expandable structure 200 and/or the second expandable structure 201 can be co-manufactured with a radiopacifier, or could be coated on the inside or outside of the expandable structure 103.
- the first elongated member 101 is further comprised of a means for penetrating a skeletal support structure (not shown).
- a means for penetrating a skeletal support structure include, but are not limited to, a stylet, drill, trocar, needle assembly, catheter and any other practicable device for penetrating a skeletal support structure.
- the means for penetrating a skeletal support structure can be coupled to the distal end of the first elongated member 101, or configured for use in conjunction with the elongated member 101.
- the means for penetrating a skeletal support structure can also be coupled to the second elongated member 102.
- the radiation source can be positioned at a predetermined location (e.g., in relation to the skeletal support structure). Where step ⁇ wise positioning is indicated, the predetermined location can be a series of dwell positions (discussed below) substantially near or within a skeletal support structure.
- the positioning of the radiation source can be controlled by the configuration of the first and second elongated members 101 and 102.
- the relevant configuration of the first and second elongated members 101 and 102 can include but is not limited to, for example, indexes or markings that communicate the positional relationship between the first and second elongated members 101 and 102 (not shown).
- Positioning of the radiation source can be aided by the use of CT scan to determine the measurement of the skeletal support structure and to calculate the distance to place in the desired position. Positioning the radiation source within the skeletal support structure can also be controlled based on the expansion of the expandable structure 103. For example, the relative amount of expansion of the expandable structure can provide positioning of the radiation source deployed within the expandable structure 103 at a number of predetermined locations within or near the skeletal support structure (e.g., within the interior volume 304 of a vertebral body 301).
- the radiation source is configured to provide a dose of radiation substantially localized within the interior of the skeletal support structure.
- the form and substance of the radiation source in conjunction with the configuration and deployment of the second elongated member 102, can be adjusted to provide a desired localized dose.
- a dose is calculable.
- a dosimetry plan can be used to calculate how long the radiation source should spend (dwell time) in specified localized positions (dwell position) within the skeletal support structure.
- the radiation source is received within the void 302 using an afterloader (not shown).
- the afterloader can be coupled to a lumen of the second elongated member 102 of the apparatus 100 for introduction of a radiation source within the lumen.
- the radiation source is a radionuclide.
- the radionuclide can be in the form of a liquid, seed, needle, pellet, particle, microsphere, or any other suitable form of radionuclide for radiation treatment.
- the radionuclide can be comprised of Au-198, Co-60, Cs-137, 1-125, 1-135, Ir-192, P-32, Pd- 103, Ra-226, Rh- 106, Ru- 106, Sr-90, Y-90 or any other isotope suitable for radiation treatment, and can be liquid, solid or generated in situ by electronic brachytherapy (available from Xofit, Inc.)
- the apparatus 100 is further comprised of a radiation shield configured to shield the radiation source (not shown).
- the shield can be configured to contain emissions from the radiation source until release of the emissions is desired, for example, to provide dose to local bone.
- the shield can be configured to enclose the second elongated member 102 and/or the expandable structure 103 coupled thereto (not shown).
- the shield can be comprised of a metal mesh, which is inserted into the interior of the skeletal support structure after expansion of the expandable structure 103.
- the shield can be incorporated into the first expandable structure 200 and/or second expandable structure 201.
- a method of using the apparatus 100 described above comprises: inserting non-axially, into an interior of a skeletal support structure, a first elongated member 101 having a lumen 104 that defines an access path into the interior of the skeletal support structure; inserting, into the lumen 104, a second elongated member 102 configured to transport a radiation source to the interior of the skeletal support structure; and transporting the radiation source through the lumen 104 into the interior of the skeletal support structure.
- the method of using the apparatus 100 further comprises expanding at least a portion of the second elongated member 102 to create a void 302 in the interior of the skeletal support structure. Expanding the second elongated member 102 to create a void 302 can optionally be executed before or after transporting the radiation source through the lumen.
- the method of using the apparatus 100 further comprises depositing a supportive material in the void 302.
- the supportive material can be bone cement (e.g., polymethyl methacrylate (PMMA), ceramics), human bone graft (autograft and allograft), synthetic derived bone substitutes such as calcium sulfate, calcium phosphate and hydroxyapatite.
- the supportive material can include a chemotherapeutic agent.
- the method step of transporting the radiation source further comprises placing the radiation source at one or more dwell positions. Furthermore, the method can include determining multiple dwell positions to provide a dose of radiation substantially localized within the interior of the skeletal support structure. Determining dwell positions includes but is not limited to computer software determination of dwell positions.
- the method step of inserting the first elongated device 101 comprises inserting the first elongated device 101 into an interior volume 304 of a vertebral body 301 through a pedicle 303 of a vertebral body 301 (see FIG. 3). In another implementation, two or more first elongated devices 101 are inserted through one or more pedicles 303 of a vertebral body 301.
- the step of inserting the first elongated device 101 can comprise inserting one or more of the first elongated device 101 into an interior volume 304 of a vertebral body 301 through the side walls of the vertebral body 301.
- the first elongated device 101 can be inserted by way of an extrapedicular, posterolateral, lateral, or anterior approach; or alternatively via the vertebral body 301 endplates.
- the method step of inserting the first elongated device 101 comprises inserting the first elongated device 101 into a skeletal support structure including bone, cartilage and ossified derivatives thereof, membrane bone and cartilage bone.
- an apparatus 100 is provided for use within the interior of a skeletal support structure that includes an expandable structure that can be comprised of at least one lumen configured to contain a radiation source.
- the apparatus 100 can comprise an expandable structure 103 configured for insertion into a skeletal support structure and optionally configured to be coupled to an elongated member such as the second elongated member 102 described above (see FIGS. l, 2A, 2B and 2D).
- the expandable structure 103 can include a first layer and a second layer.
- the first and second layers can be configured to receive a radiation source between the first layer and the second layer.
- the expandable structure 103 includes a primary lumen 202, and at least one secondary lumen 203.
- the primary and secondary lumens 202 and 203 are configured to be in fluid communication with a lumen in the second elongated member 102.
- the primary and secondary lumens 202 and 203 extend into and substantially span the length of the second elongated member 102.
- the first and second expandable structures 200 and 201 are comprised of a material having properties or characteristics including compliant or non-compliant and combinations thereof.
- compliant includes the properties of flexibility in an elastic, expandable or bendable way. Additionally, as used herein, “non-compliant” includes a rigid quality although, depending on the context, may not imply complete rigidity. By varying the incorporation of such material when manufacturing the first and second expandable structures 200 and 201, different sizes, shapes and consistencies of the un-expanded and expanded first and second expandable structures 200 and 201 can be achieved.
- the expandable structure 103 can be configured for insertion into a skeletal structure in an unexpanded configuration. Insertion of the unexpanded expandable structure 103 into the skeletal support structure can create a void 302 within the skeletal support structure.
- the expandable structure 103 can further be configured to create or expand a void within a skeletal support structure upon expansion of the expandable structure 103.
- the expandable structure 103 is configured for insertion into a void (e.g., void 302) in an unexpanded configuration (see FIG. 4A), expanded into the void to an expanded configuration (see FIG. 4B), and unexpanded after expansion.
- a void 302 in the interior volume 304 of a vertebral body 301 can be increased by the expansion of the first and second expandable structures 200 and 201 within the interior volume 304.
- the void 302 is provided when one or more of the first and second expandable structures 200 and 201 are expanded, which result from the compaction of cancellous bone 305.
- the expandable structure 103 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.
- the expandable structure 103 of the apparatus 100 can comprise a first expandable structure 200, and a second expandable structure 201 disposed within the first expandable structure 200.
- the first and second expandable structures 200 and 201 include interior and exterior walls.
- a substance e.g., a fluid
- the fluid can be caused to force against the interior wall of the second expandable structure 201 to provide expansion of the expandable structure 103 including the first and second expandable structures 200 and 201 (not shown).
- a secondary lumen 203 disposed between the first and second expandable structures 200 and 201.
- the secondary lumen 203 is configured to receive a substance (e.g., a fluid).
- the substance received in the secondary lumen 203 can be a radiation source.
- the first expandable structure 200 can be configured for removal from the apparatus 100, wherein upon removal, the second expandable structure 201 remains attached to the second elongated member 102 of the apparatus 100.
- the second expandable structure 201 can be configured for removal from the apparatus 100, wherein upon removal of the second expandable structure 201, the first expandable structure 200 is left attached to the second elongated member 102 of the apparatus 100.
- the configuration of the expandable structure 103 forms a tube, sleeve, pocket, pouch, sac, bag, vessel or other suitable enclosed space.
- the expandable structure 103 includes an expandable geometry configured to reversibly expand to a desired shape (not shown). Examples of such expandable geometries include, but are not limited to, coiled wires, various types of springs, and self-expanding stents or scaffolds.
- the apparatus 100 further comprises an insertion sleeve configured to substantially surround the expandable structure 103 (not shown).
- the insertion sleeve can be used to protect the expandable structure during placement and removal from the interior of the skeletal support structure.
- the insertion sleeve can also protect the surrounding tissues during removal of diseased tissue or instruments, which have come into contact with diseased tissue.
- the insertion sleeve can help prevent "seeding" of the diseased tissue to other tissues in the access pathway.
- the expandable structure 103 is comprised of a primary lumen 202 and a secondary lumen 203.
- the primary lumen 202 can be configured for expanding the expandable structure 103 and the secondary lumen 203 can be configured for containing the radiation source (see FIGS. 4A and 4B).
- the primary lumen 202 can be configured for containing the radiation source while the secondary lumen 203 is configured for expanding the expandable structure 103.
- At least one secondary lumen 203 is disposed substantially parallel to the long-axis of the second elongated member 102. Additionally, the at least one secondary lumen 203 is disposed circumferentially about the expandable structure 103 (see FIGS. 4A and 4B). Any of a number of configurations for disposing the at least one secondary lumen 203 in relation to the second elongated member 102 and the expandable structure 103 can be used. For example the number and orientation of the secondary lumens (i.e., the at least one secondary lumen 203) can be varied to optimize containing and transporting the radiation source.
- the expandable structure 103 is comprised of one or more lumens having been co-manufactured with the radiation source.
- the at least one secondary lumen 203 can be co-manufactured with the radiation source.
- the primary lumen 202 can be co-manufactured with the radiation source.
- the at least one lumen As shown in FIGS 4A-D, in one implementation, the at least one lumen
- the 203 of the expandable structure 103 comprises a catheter 400 disposed within and having an opening 402 substantially near the distal end of the expandable structure 103.
- the opening 402 may accommodate the passage of a guidewire or stiffening stylet.
- the catheter 400 comprises a catheter lumen 401 and can extend into and substantially span the length of the second elongated member 102 (see FIGS. 4A-D).
- the at least one lumen 203 of the expandable structure 103 does not include an opening or exit near the distal end of the expandable structure 103.
- a method of using the above described expandable structure 103 comprises inserting the expandable structure 103 into a skeletal support structure, wherein the expandable structure 103 comprises at least one lumen configured to receive a radiation source; expanding the expandable structure 103; and transporting the radiation source through the at least one lumen into the skeletal support structure.
- the method further comprises depositing a supportive material in the skeletal support structure.
- the supportive material can be bone cement (e.g., polymethyl methacrylate (PMMA), ceramics), human bone graft (autograft and allograft), synthetic derived bone substitutes such as calcium sulfate, calcium phosphate and hydroxyapatite.
- the supportive material can include a chemotherapeutic agent or a radioactive agent.
- the apparatus 100 is configured to provide minimally invasive insertion into a skeletal support structure.
- the apparatus 100 comprising first and second elongated members 101 and 102 includes a minimally invasive configuration for deployment within the interior volume 304 of a vertebral body 301.
- the configuration is minimally invasive since only a small access through the skin and muscle layers to a desired part of the vertebral body 301 (e.g., through a pedicle 303 as shown in FIG. 3) is required to introduce the apparatus 100 within the interior volume 304.
- the minimally invasive approach can be applied to the side walls of the vertebral body 301.
- a desired part of the vertebral body 301 can be accessed through an extrapedicular, posterolateral, lateral, or anterior approach; or alternatively via the vertebral body 301 endplates.
- Other skeletal support structures the minimally invasive insertion approach can be applied to include but are not limited to, bone, cartilage and ossified derivatives thereof, membrane bone and cartilage bone.
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Abstract
Description
Claims
Priority Applications (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2007541420A JP5006204B2 (en) | 2004-11-15 | 2005-11-14 | Apparatus comprising an inflatable structure configured for insertion into a skeletal support structure |
EP05851628A EP1814625A1 (en) | 2004-11-15 | 2005-11-14 | System and method for delivering a therapeutic agent for bone disease |
Applications Claiming Priority (14)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US48539495A | 1995-06-07 | 1995-06-07 | |
US08/659,678 US5827289A (en) | 1994-01-26 | 1996-06-05 | Inflatable device for use in surgical protocols relating to treatment of fractured or diseased bones |
US08/871,114 US6248110B1 (en) | 1994-01-26 | 1997-06-09 | Systems and methods for treating fractured or diseased bone using expandable bodies |
US91180597A | 1997-08-15 | 1997-08-15 | |
US98687697A | 1997-12-08 | 1997-12-08 | |
US5473601A | 2001-10-24 | 2001-10-24 | |
US10/044,843 US20030032963A1 (en) | 2001-10-24 | 2002-01-11 | Devices and methods using an expandable body with internal restraint for compressing cancellous bone |
US10/265,922 US7261720B2 (en) | 2002-01-11 | 2002-10-07 | Inflatable device for use in surgical protocol relating to fixation of bone |
US10/990,285 US20050131268A1 (en) | 1995-06-07 | 2004-11-15 | System and method for delivering a therapeutic agent for bone disease |
US10/990,285 | 2004-11-15 | ||
US10/990,291 | 2004-11-15 | ||
US10/989,733 US20050131267A1 (en) | 1995-06-07 | 2004-11-15 | System and method for delivering a therapeutic agent for bone disease |
US10/989,733 | 2004-11-15 | ||
US10/990,291 US20050131269A1 (en) | 1995-06-07 | 2004-11-15 | System and method for delivering a therapeutic agent for bone disease |
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WO2006053312A1 true WO2006053312A1 (en) | 2006-05-18 |
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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PCT/US2005/041257 WO2006053312A1 (en) | 1995-06-07 | 2005-11-14 | System and method for delivering a therapeutic agent for bone disease |
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WO (1) | WO2006053312A1 (en) |
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