Search Images Maps Play YouTube News Gmail Drive More »
Sign in
Screen reader users: click this link for accessible mode. Accessible mode has the same essential features but works better with your reader.

Patents

  1. Advanced Patent Search
Publication numberUS20040010263 A1
Publication typeApplication
Application numberUS 10/617,895
Publication dateJan 15, 2004
Filing dateJul 11, 2003
Priority dateJun 1, 1998
Also published asCA2333761A1, CA2333761C, DE69942858D1, EP1083836A1, EP1083836A4, EP1083836B1, US6607544, US6979341, US20020156482, US20040267271, US20060095064, US20080065139, WO1999062416A1
Publication number10617895, 617895, US 2004/0010263 A1, US 2004/010263 A1, US 20040010263 A1, US 20040010263A1, US 2004010263 A1, US 2004010263A1, US-A1-20040010263, US-A1-2004010263, US2004/0010263A1, US2004/010263A1, US20040010263 A1, US20040010263A1, US2004010263 A1, US2004010263A1
InventorsRyan Boucher, Mark Reiley, Robert Scribner, Karen Talmadge
Original AssigneeKyphon Inc.
Export CitationBiBTeX, EndNote, RefMan
External Links: USPTO, USPTO Assignment, Espacenet
Expandable preformed structures for deployment in interior body regions
US 20040010263 A1
Abstract
A tool for deploying an expandable structure into interior body regions provides a catheter body having an interior lumen. The catheter body carries an expandable structure. A stylet is sized configured for passage through the lumen and adapted to straighten the expandable structure during deployment into an interior body region.
Images(6)
Previous page
Next page
Claims(5)
We claim:
1. A tool for deploying an expandable structure into interior body regions, the tool comprising
a catheter body defining an interior lumen,
an expandable structure having a distal end and carried by the catheter body, and
a stylet having a proximal end and being sized and configured for passage through the lumen and adapted to straighten the expandable structure during deployment into an interior body region.
2. A tool as in claim 1
wherein the stylet is substantially rigid.
3. A tool as in claim 1
wherein the stylet is made of stainless steel.
4. A tool as in claim 1
wherein, after passage of the stylet through the lumen, the proximal end of the stylet is coupleable to the catheter body.
5. A tool as in claim 1
wherein, after passage of the stylet through the lumen, the stylet abuts against the distal end of the expandable structure.
Description
    RELATED APPLICATIONS
  • [0001]
    This application is a divisional of copending U.S. patent application Ser. No. 09/420,529, filed Oct. 19, 1999, which is a continuation-in-part of U.S. patent application Ser. No. 09/088,459, filed Jun. 1, 1998, and entitled “Expandable Preformed Structures for Deployment in Interior Body Regions,” now abandoned.
  • FIELD OF THE INVENTION
  • [0002]
    The invention relates to expandable structures, which, in use, are deployed in interior body regions of humans and other animals.
  • BACKGROUND OF THE INVENTION
  • [0003]
    The deployment of expandable structures, generically called “balloons,” into cancellous bone is known. For example, U.S. Pat. Nos. 4,969,888 and 5,108,404 disclose apparatus and methods using expandable structures in cancellous bone for the fixation of fractures or other osteoporotic and non-osteoporotic conditions of human and animal bones.
  • SUMMARY OF THE INVENTION
  • [0004]
    According to one aspect of the invention, a tool for deploying an expandable structure into bone comprises a catheter body defining an interior lumen and having a proximal end and a distal end. An expandable structure having a distal end is carried by the catheter body. A stylet having a proximal end is sized and configured for passage through the lumen and adapted to straighten the expandable structure during deployment into an interior body region.
  • [0005]
    In one embodiment, the stylet is substantially rigid. In one embodiment, the stylet is made of stainless steel.
  • [0006]
    According to another aspect of the invention, the proximal end of the stylet is coupleable to the catheter body after passage of the stylet through the lumen.
  • [0007]
    According to yet another aspect of the invention, the stylet abuts against the distal end of the expandable structure after passage of the stylet through the lumen.
  • [0008]
    Features and advantages of the inventions are set forth in the following Description and Drawings, as well as in the appended claims.
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • [0009]
    [0009]FIG. 1 is a coronal view of a vertebral body;
  • [0010]
    [0010]FIG. 2 is a lateral view of the vertebral body shown in FIG. 1;
  • [0011]
    [0011]FIG. 3 is a plan view of a tool which carries at its distal end an expandable structure that embodies features of the invention;
  • [0012]
    [0012]FIG. 4 is an enlarged view of the proximal end of the tool shown in FIG. 3, showing the handle and connected luer fittings;
  • [0013]
    [0013]FIG. 5 is an enlarged view of the distal end of the tool shown in FIG. 3, showing the expandable structure;
  • [0014]
    [0014]FIG. 6 is a plan view of the tool shown in FIG. 3, also showing a stylet that can be inserted into the tool to straighten the expandable structure during deployment in bone;
  • [0015]
    [0015]FIG. 7 is an enlarged view of the distal end of the tool shown in FIG. 3, also showing an insertion sleeve that can be used to compact the expandable structure prior to insertion into a cannula;
  • [0016]
    [0016]FIG. 8 is a top view of a mold forming the expandable structure shown in FIG. 5;
  • [0017]
    [0017]FIG. 9 is a coronal view of the vertebral body shown in FIG. 1, with the tool shown in FIG. 3 deployed to compress cancellous bone as a result of inflating the expandable structure;
  • [0018]
    [0018]FIG. 10 is a coronal view of the vertebral body shown in FIG. 9, upon removal of the tool, showing the cavity formed by the compression of cancellous bone by the expandable structure;
  • [0019]
    [0019]FIG. 11 is an enlarged view of the expandable structure shown in FIG. 5, diagrammatically showing the expansion characteristics of the structure; and
  • [0020]
    [0020]FIG. 12 is a graph which plots the effects of increasing pressure applied to the interior of the structure to the expanded volume of the structure.
  • [0021]
    The invention may be embodied in several forms without departing from its spirit or essential characteristics. The scope of the invention is defined in the appended claims, rather than in the specific description preceding them. All embodiments that fall within the meaning and range of equivalency of the claims are therefore intended to be embraced by the claims.
  • DESCRIPTION OF THE PREFERRED EMBODIMENT
  • [0022]
    The preferred embodiment describes improved systems and methods that embody features of the invention in the context of treating bones. This is because the new systems and methods are advantageous when used for this purpose. However, aspects of the invention can be advantageously applied for diagnostic or therapeutic purposes in other areas of the body.
  • [0023]
    The new systems and methods will be more specifically described in the context of the treatment of human vertebra. Of course, other human or animal bone types can be treated in the same or equivalent fashion.
  • [0024]
    I. Anatomy of a Vertebral Body
  • [0025]
    [0025]FIG. 1 shows a coronal (top) view of a human lumbar vertebra 12. FIG. 2 shows a lateral (side) view of the vertebra 12. The vertebra 12 includes a vertebral body 26, which extends on the anterior (i.e., front or chest) side of the vertebra 12. The vertebral body 26 is shaped generally like a marshmallow.
  • [0026]
    As FIGS. 1 and 2 show, the vertebral body 26 includes an exterior formed from compact cortical bone 28. The cortical bone 28 encloses an interior volume of reticulated cancellous, or spongy, bone 32 (also called medullary bone or trabecular bone).
  • [0027]
    The spinal canal 36 (see FIG. 1), is located on the posterior (i.e., back) side of each vertebra 12. The spinal cord (not shown) passes through the spinal canal 36. The vertebral arch 40 surrounds the spinal canal 36. Left and right pedicles 42 of the vertebral arch 40 adjoin the vertebral body 26. The spinous process 44 extends from the posterior of the vertebral arch 40, as do the left and right transverse processes 46.
  • [0028]
    It may be indicated, due to disease or trauma, to compress cancellous bone within the vertebral body. The compression, for example, can be used to form an interior cavity, which receives a filling material, e.g., a flowable material that sets to a hardened condition, like bone cement, allograft tissue, autograft tissue, hydroxyapatite, or synthetic bone substitute, as well as a medication, or combinations thereof, to provide improved interior support for cortical bone or other therapeutic functions, or both. The compaction of cancellous bone also exerts interior force upon cortical bone, making it possible to elevate or push broken and compressed bone back to or near its original prefracture, or other desired, condition.
  • [0029]
    II. Tool for Treating Vertebral Bodies
  • [0030]
    FIGS. 3 to 5 show a tool 48 for accessing bone for the purpose of compacting cancellous bone. The tool 48 includes a catheter tube assembly 10. The distal end of the catheter tube assembly 10 carries an expandable structure 56. In use, the structure is deployed and expanded inside bone, e.g., in the vertebral body 26 shown in FIGS. 1 and 2, to compact cancellous bone 32, as will be described later.
  • [0031]
    As best shown in FIGS. 4 and 5, the catheter tube assembly 10 includes an outer catheter body 16 and an inner catheter body 18, which extends through the outer catheter body 16. The proximal ends of the outer and inner catheter bodies 16 and 18 are coupled to a y-shaped adaptor/handle 14 (as FIG. 4 shows).
  • [0032]
    As FIG. 5 shows, the expandable structure 56 is coupled at its proximal end to the distal end of the outer catheter body 16. Likewise, the expandable structure is coupled at its distal end to the distal end of the inner catheter body 18.
  • [0033]
    The outer catheter body 16 defines an interior lumen 20 (see FIGS. 4 and 5), through which the inner catheter body 18 extends. In use, the interior lumen 20 conveys a pressurized liquid, e.g., sterile water, radiopaque fluid (such as CONRAY™ solution, from Mallinkrodt, Inc., or another fluid into the structure 56, to expand it.
  • [0034]
    A first female-to-male luer fitting 22 is secured to the handle 14 and serves, in use, to couple the interior lumen 20 to a source of pressured liquid.
  • [0035]
    As FIGS. 4 and 5 also show, the inner catheter body 18 defines an interior lumen 24, which passes concentrically through the interior lumen 20 of the outer catheter body 16. In use, the interior lumen 24 can serve to convey a flushing liquid, e.g., sterile saline, for discharge through an opening 30 at the distal end of the inner catheter body 18.
  • [0036]
    A second female-to-male luer fitting 34, which is joined to the inner catheter body 18, is also secured to the handle 14. If desired, the second female-to-male luer fitting 34 can serve to couple the interior lumen 24 to a source of flushing liquid. In addition, the interior lumen 24 of the inner catheter body 18 can accommodate passage of a stylet 38 (see FIG. 6). The distal end of the stylet 38 is preferably radiused, to prevent puncture of the inner catheter body 18.
  • [0037]
    As FIG. 6 shows, the stylet 38 desirably carries a screw cap 50, which when attached to the second luer fitting 34, holds the stylet 38 in place within the inner catheter body 18. In the illustrated embodiment, the proximal end of the inner catheter body 18 includes a flared region 52 (see FIG. 4) where it joins the second luer fitting 34. The flared region 52 allows smooth insertion of the stylet 38, free of interference or contact with the peripheral edge of the inner catheter body 18.
  • [0038]
    When the cap 50 is screwed into the second luer fitting 34, the stylet 38 desirably extends through the entire interior lumen 24 of the inner catheter body 18. In the illustrated embodiment, the opening 30 at the distal end of the inner catheter body 18 is sized to block passage of the stylet 38 beyond the distal end of the inner catheter body 18. Thus, when inserted through the interior lumen 24 and locked to the handle 14 with the screw cap 50, the stylet 38 desirably abuts against the distal end of the structure 56. The presence of the stylet 38 desirably prevents the structure 56 from bunching or deflecting when the structure 56 is inserted into the cannula 78 and/or bone.
  • [0039]
    The tool 48 also includes an insertion sleeve 54 (see FIG. 7). The insertion sleeve 54 is carried for sliding movement along the outer catheter body 16. The insertion sleeve 54 slides forward over the structure 56 (shown in phantom lines in FIG. 7), to protect and compress the structure 56 during its insertion into the cannula 78. Once the structure 56 is deployed into the cannula 78, the insertion sleeve 54 slides aft away from the structure 56 (shown in solid lines in FIG. 7), and can, if desired, engage the handle 14.
  • [0040]
    Various materials can be selected for the component parts of the tool 48. Furthermore, the dimensions of the component parts of the tool 48 can also vary, according to its intended use. The following table lists preferred component materials and dimensions, which are well suited for a tool 48 that can be deployed for use in a vertebral body:
    Component Material Dimension (Inches)
    Outer 99% TEXIN ® 5270 Outside Diameter:
    catheter Polyurethane 0.102
    body 16 1% Titanium Inside Diameter:
    Dioxide 0.078
    (Colorant)
    Inner A Blend Outside Diameter:
    catheter Comprising: 0.063
    body 18 25% TEXIN ® 5286
    Polyurethane Inside Diameter:
    75% TEXIN ® 5270 0.043
    Polyurethane
    Expandable TEXIN ® 5286 As Formed:
    Structure Polyurethane
    Axial Length (From
    Distal End of Outer
    Catheter Tube to
    Distal end of Inner
    Catheter Tube): 0.949
    Compressed Diameter:
    0.160″
    Non - Expanded
    Diameter: 0.270″
    Tool Total End to End
    Length: 15.75
    Stylet Stainless Steel Outside Diameter:
    0.038
    Insertion PEBAX ® Tubing Outside Diameter:
    sleeve 54 0.195
    Inside Diameter:
    0.160
    Length: 1.5
  • [0041]
    The blend of polyurethane materials for the inner catheter body 18 desirably enhances the strength of the distal bond between the inner catheter body 18 and the structure 56, due to the presence in both components of the common TEXIN® 5286 Polyurethane material. This improved bond allows the length of the distal bond to be reduced without sacrificing bond integrity. In addition, because both the inner catheter body 18 and the structure 56 are clear plastic, visual inspection of the distal bond area is simplified.
  • [0042]
    The component parts of the tool 48 can be formed and assembled in various ways. A preferred assembly will now be described.
  • [0043]
    A. The Expandable Structure
  • [0044]
    The material from which the structure 56 is made should possess various physical and mechanical properties to optimize its functional capabilities to compact cancellous bone. The three most important properties are the ability to expand its volume; the ability to deform in a desired way when expanding and assume a desired shape inside bone; and the ability to withstand abrasion, tearing, and puncture when in contact with cancellous bone.
  • [0045]
    1. Expansion Property
  • [0046]
    A first desired property for the structure material is the ability to expand or otherwise increase its volume without failure. This property enables the structure 56 to be deployed in a collapsed, low profile condition subcutaneously, e.g., through a cannula, into the targeted bone region. This property also enables the expansion of the structure 56 inside the targeted bone region to press against and compress surrounding cancellous bone, or move cortical bone to a prefracture or other desired condition, or both.
  • [0047]
    The desired expansion property for the structure material can be characterized by ultimate elongation properties, which indicate the degree of expansion that the material can accommodate prior to failure. Sufficient ultimate elongation permits the structure 56 to compact cortical bone, as well as lift contiguous cortical bone, if necessary, prior to wall failure. Desirably, the structure 56 will comprise material able to undergo an ultimate elongation of at least 50%, prior to wall failure when expanded outside of bone. More desirably, the structure will comprise material able to undergo an ultimate elongation of at least 150%, prior to wall failure, when expanded outside of bone. Most desirably, the structure will comprise material able to undergo an ultimate elongation of at least 300%, prior to wall failure, when expanded outside of bone.
  • [0048]
    2. Shape Property
  • [0049]
    A second desired property for the material of the structure 56 is the ability to predictably deform during expansion, so that the structure 56 consistently achieves a desired shape inside bone.
  • [0050]
    The shape of the structure 56, when expanded in bone, is desirably selected by the physician, taking into account the morphology and geometry of the site to be treated. The shape of the cancellous bone to be compressed, and the local structures that could be harmed if bone were moved inappropriately, are generally understood by medical professionals using textbooks of human skeletal anatomy along with their knowledge of the site and its disease or injury, and also taking into account the teachings of U.S. patent application Ser. No. 08/788,786, filed Jan. 23, 1997, and entitled “Improved Inflatable Device for Use in Surgical Protocol Relating to Fixation of Bone,” which is incorporated herein by reference. The physician is also desirably able to select the desired expanded shape inside bone based upon prior analysis of the morphology of the targeted bone using, for example, plain film x-ray, fluoroscopic x-ray, or MRI or CT scanning. The expanded shape inside bone is selected to optimize the formation of a cavity that, when filled with a selected material, provides support across the region of the bone being treated. The selected expanded shape is made by evaluation of the predicted deformation that will occur with increased volume due to the shape and physiology of the targeted bone region.
  • [0051]
    In some instances, it is desirable, when creating a cavity, to also move or displace the cortical bone to achieve the desired therapeutic result. Such movement is not per se harmful, as that term is used in this Specification, because it is indicated to achieve the desired therapeutic result. By definition, harm results when expansion of the structure 56 results in a worsening of the overall condition of the bone and surrounding anatomic structures, for example, by injury to surrounding tissue or causing a permanent adverse change in bone biomechanics.
  • [0052]
    As one general consideration, in cases where the bone disease causing fracture (or the risk of fracture) is the loss of cancellous bone mass (as in osteoporosis), the selection of the expanded shape of the structure 56 inside bone should take into account the cancellous bone volume which should be compacted to achieve the desired therapeutic result. An exemplary range is about 30% to 90% of the cancellous bone volume, but the range can vary depending upon the targeted bone region. Generally speaking, compacting less of the cancellous bone volume leaves more uncompacted, diseased cancellous bone at the treatment site.
  • [0053]
    Another general guideline for the selection of the expanded shape of the structure 56 inside bone is the amount that the targeted fractured bone region has been displaced or depressed. The controlled deformation diameter expansion of the structure 56 within the cancellous bone region inside a bone can elevate or push the fractured cortical wall back to or near its anatomic position occupied before fracture occurred. Generally speaking, inadequate compaction of cancellous bone results in less lifting of contiguous cortical bone.
  • [0054]
    For practical reasons, it is desired that the expanded shape of the structure 56 inside bone, when in contact with cancellous bone, substantially conforms to the shape of the structure 56 outside bone, when in an open air environment. This allows the physician to select in an open air environment a structure having an expanded shape desired to meet the targeted therapeutic result, with the confidence that the expanded shape inside bone will be similar in important respects.
  • [0055]
    An optimal degree of shaping can be achieved by material selection and by special manufacturing techniques, e.g., thermoforming or blow molding, as will be described in greater detail later.
  • [0056]
    3. Toughness Property
  • [0057]
    A third desired property for the structure 56 is the ability to resist surface abrasion, tearing, and puncture when in contact with cancellous bone. This property can be characterized in various ways.
  • [0058]
    One way of measuring a material's resistance to abrasion, tearing and/or puncture is by a Taber Abrasion test. A Taber Abrasion test evaluates the resistance of a material to abrasive wear. For example, in a Taber Abrasion test configured with an H-18 abrasive wheel and a 1 kg load for 1000 cycles (ASTM Test Method D 3489), Texin® 5270 material exhibits a Taber Abrasion value of approximately 75 mg loss. As another example, under the same conditions Texin® 5286 material exhibits a Taber Abrasion value of approximately 30 mg loss. Typically, a lower Taber Abrasion value indicates a greater resistance to abrasion. Desirably, the structure will comprise material having a Taber Abrasion value under these conditions of less than approximately 200 mg loss. More desirably, the structure will comprise material having a Taber Abrasion value under these conditions of less than approximately 145 mg loss. Most desirably, the structure will comprise material having a Taber Abrasion value under these conditions of less than approximately 90 mg loss.
  • [0059]
    Another way of measuring a material's resistance to abrasion, tearing and/or puncture is by Elmendorf Tear Strength. For example, under ASTM Test Method D 624, Texin® 5270 material exhibits a Tear Strength of 1,100 lb-ft/in. As another example, under the same conditions, Texin 5286 exhibits a Tear Strength of 500 lb-ft/in. Typically, a higher Tear Strength indicates a greater resistance to tearing. Desirably, the structure will comprise material having a Tear Strength under these conditions of at least approximately 150 lb-ft/in. More desirably, the structure will comprise material having a Tear Strength under these conditions of at least approximately 220 lb-ft/in. Most desirably, the structure will comprise material having a Tear Strength under these conditions of at least approximately 280 lb-ft/in.
  • [0060]
    Another way of measuring a material's resistance to abrasion, tearing and/or puncture is by Shore Hardness. For example, under ASTM Test Method D 2240, Texin® 5270 material exhibits a Shore Hardness of 70D. As another example, under the same conditions, Texin® 5286 material exhibits a Shore Hardness of 86A. Typically, a lower Shore Hardness number on a given scale indicates a greater degree of elasticity, flexibility and ductility. Desirably, the structure will comprise material having a Shore Hardness under these conditions of less than approximately 75D. More desirably, the structure will comprise material having a Shore Hardness under these conditions of less than approximately 65D. Most desirably, the structure will comprise material having a Shore Hardness under these conditions of less than approximately 10A.
  • [0061]
    It should be noted that a structure incorporating a plurality of materials, such as layered materials and/or composites, may possess significant resistance to surface abrasion, tearing and puncture. For example, a layered expandable structure incorporating an inner body formed of material having a Taber Abrasion value of greater than 200 mg loss and an outer body having a shore hardness of greater than 75D might possess significant resistance to surface abrasion, tearing and puncture. Similarly, other combinations of materials could possess the desired toughness to accomplish the desired goal of compressing cancellous bone and/or moving cortical bone prior to material failure.
  • [0062]
    4. Creating a Pre-Formed Structure
  • [0063]
    The expansion and shape properties just described can be enhanced and further optimized for compacting cancellous bone by selecting an elastomer material, which also possess the capability of being preformed, i.e., to acquire a desired shape by exposure, e.g., to heat and pressure, e.g., through the use of conventional thermoforming or blow molding techniques. Candidate materials that meet this criteria include polyurethane, silicone, thermoplastic rubber, nylon, and thermoplastic elastomer materials.
  • [0064]
    As described earlier, in the illustrated embodiment, TEXIN® 5286 polyurethane material is used. This material is commercially available from Bayer in pellet form.
  • [0065]
    The pellets can be processed and extruded in a tubular shape using, e.g., a screw type (888 4:1) extrusion machine, with a GENCA™ head, with a single finger spider and a 80-100-200 screen. The following table summarizes representative process settings for the extrusion.
    Extrusion Element Nominal Setting
    Die 0.338″
    Mandrel 0.180″
    Zone 1 Set/Actual 270 degrees F.
    Zone 2 Set/Actual 370 degrees F.
    Zone 3 Set/Actual 380 degrees F.
    Melt Temperature 405 degrees F.
    Clamp Set/Actual 370 degrees F.
    Adaptor Set/Actual 380 degrees F.
    Die 1 Set/Actual 380 degrees F.
    Die 2 Set/Actual 380 degrees F.
    Extruder 1600 RPM
    Barrel 1600 PSI
    Motor 5 Amps
    Mandrel Air 2″ of water
    Entry Hole Diameter 0.3″
    Bath Dist. from Tooling 1″
    Water Flow/Temperature 6 GPH/70 degrees F.
    Air Wipe 20 PSI
    Speed 21.5 FPM
    Min Dryer Time/Temperature Overnight/160 degrees F.
  • [0066]
    The ultimate dimensions of the tubular extrusion can vary, according to the desired size and shape of the structure 56. In a representative embodiment, the tubular extrusion has an outside diameter of 0.164″, and inner diameter of 0.092″, and a wall diameter of 0.36″. Reasonable processing tolerances can of course be established
  • [0067]
    The tubular extrusion is cut into individual lengths for further processing. The tube length can vary, according to the desired configuration of the structure 56. In a representative embodiment, each tube is cut to a length of about 48″ for further processing.
  • [0068]
    The structure 56 is formed by exposing a cut tube length 60 to heat and then enclosing the heated tube 60 within a mold 58 while positive interior pressure is applied to the tube length 60. The mold 10 can be part of a conventional balloon forming machine, such as the Model No. 9608C made by Interface Associates.
  • [0069]
    As FIG. 8 shows, the mold 58 includes a tube holding channel 62, through which the tube length 60 extends for processing. The holding channel 62 includes a formed intermediate cavity 64, which possesses a desired geometry. The cavity 64 defines the geometry intended for the structure 56.
  • [0070]
    In the illustrated embodiment, the cavity 64 possesses two enlarged cavity spaces 92 and 94 with an intermediate channel 96. The dimensions of the spaces 92, 94 and channel 96 can, of course, vary according to the desired dimensions of the structure 56.
  • [0071]
    In a representative embodiment, each enlarged cavity space 92 and 94 extends 0.395″ on each side of the center line 66. The maximum diameter of each cavity space 92 and 94 is 0.314″, and the maximum diameter for the spacing channel 96 is 0.174″. Desirably, all surfaces within the mold 58 are radiused to provide a smooth transition.
  • [0072]
    Prior to heating, one end of the tube length 60 is attached to a source of pressurized air, e.g., nitrogen. The other end of the tube length 60 is gripped and closed. The tube is desirably subjected to a tensioning force (e.g., 16 oz).
  • [0073]
    The tube length 60 is then subjected to a heating cycle. During the heating cycle, the tube length 60 is heated to a predetermined heated temperature for a set dwell time. The heated temperature and dwell time are selected to soften the tube length 60 for subsequent stretching and pressure shaping.
  • [0074]
    The range of heated temperatures in which softening occurs will depend upon the particular composition of the polymeric material used. For example, for the polyurethane tube of the dimensions described above, a heated temperature of 290 degrees F. and a dwell time of 220 seconds can be used. An operating range of softening temperatures for a given plastic material can be empirically determined. Suitable processing tolerances can also be empirically established.
  • [0075]
    When the heating cycle ends, the heat-softened tube length 60 is stretched by pulling it a set amount. The stretching desirably reduces the thickness of the tube walls. In a representative embodiment, the tube is stretched approximately 0.198″ to each side. The amount of stretching is selected to facilitate shaping without significantly reducing the resistance of the material, once shaped, to puncture.
  • [0076]
    The mold 58 then closes over the heated and stretched tube length 60. Pressurized air (typically, nitrogen) is introduced through the interior of the tube length 60 for a set amount of dwell time at a set flow rate. The magnitude of pressure, dwell time, and flow rate will vary, depending upon the wall thickness and other physical characteristics of the material used. For the polyurethane tube of the dimensions described, a pressure of 100 PSI at a flow rate of 0.4 l/min for a dwell time of 45 seconds can be used.
  • [0077]
    The introduction of pressurized air into tube length 60 causes the tube region located within the cavity 64 to expand or billow outward, forming the structure 56. The cavity 64 limits the extent to which the structure 56 expands. The structure 56, upon expansion in the cavity 64, will desirably conform to the geometry of the cavity 64. During the pressurization phase, the flow of pressurized air can be used to help cool the tube length 60.
  • [0078]
    After the pressurization phase, the tube length 60 is removed from the mold. The source of pressurized air is detached. Excess material on both sides of the formed structure region is discarded. Preferably, at least one inch of tube material is left on each side of the formed structure region to aid handling and identification during further processing.
  • [0079]
    B. Assembly of the Tool
  • [0080]
    1. Assembling the Outer Catheter Body
  • [0081]
    In a representative embodiment, the outer catheter body 16 comprises an extruded tube, made from 99% TEXIN® 5270 Material and 1% Titanium Dioxide. The TEXIN® material can be purchased in pellet form from Bayer. The outer catheter body can be extruded in a tubular shape using, e.g., a screw type (888 4:1) extrusion machine, with a GENCA™ head, with a single finger spider and a C5WB23 screen. The following table summarizes representative process settings for the extrusion.
    Extrusion Element Nominal Setting
    Die 0.203″
    Mandrel 0.150″
    Zone 1 Set/Actual 300 degrees F.
    Zone 2 Set/Actual 340 degrees F.
    Zone 3 Set/Actual 400 degrees F.
    Clamp Set/Actual 24.6 degrees F.
    Adaptor Set/Actual 400 degrees F.
    Die 1 Set/Actual 400 degrees F.
    Die 2 Set/Actual 400 degrees F.
    Extruder 400 RPM
    Motor In. 2300 Auto/Dis. 2929
    Mandrel Air 5.2 PSI
    Entry Hole Diameter- 300-½″
    Distribution
    Water Flow/Temperature 20 ccm
    Air Wipe 20 PSI
    Speed 39 FPM
    Min Dryer Time/Temperature Overnight/l60 degrees F.
  • [0082]
    The extrusion is initially cut to lengths of 16″ for assembly.
  • [0083]
    Each tubing length comprising an outer catheter body 16 preferably undergoes annealing, e.g., by oven curing at 60 to 70 degrees C. for 2 to 6 hours. Annealing reduces the incidence of shrinkage of the outer catheter body 16 during sterilization and/or storage prior to use.
  • [0084]
    The proximal end of the structure 56 is heat bonded to the distal end of the outer catheter body 16 in the presence of an overlying ring of silicone tubing 68 (see FIG. 5), which compresses the outer catheter body 16 and the proximal end of the structure 56 together during the heat bonding process. In one representative assembly technique, a support mandrel (e.g., having an outside diameter of 0.075″) is inserted within the outer catheter body 16, and the proximal end of the structure 56 is slid over the distal end of the outer catheter body 16. A length of the silicone tubing 68 (having, e.g., an initial inside diameter of 0.104″) is subsequently slid over the proximal end of the structure 56 and the catheter body 16. Heat from the heat box is applied to the silicone tubing, and the structure and outer catheter body 16 fuse together. The silicone tubing is then discarded.
  • [0085]
    For the materials and dimensions described, representative settings for the heat box are a temperature of 545 degrees F., an air flow of 40 SCFH, and an air pressure of 20 to 30 PSI. At this setting, the silicone tubing 68 and junction of the structure 56 and the outer catheter body 16 are exposed to heat for 60 seconds, and are rotated 180 degrees after the first 30 seconds. The resulting heat bond is allowed to cool.
  • [0086]
    The outer catheter body 16 can then be cut to a desired final length, e.g., which in a representative embodiment is 350 mm measured from the center of the structure 56. In the illustrated embodiment (see FIG. 4), heat shrink tubing 70, which bears appropriate identification information for the tool 48, is bonded about the outer catheter body 16, about 0.5″ from the proximal end of the outer catheter body 16.
  • [0087]
    A suitable UV adhesive (e.g., Dymax 204 CTH, available commercially from Dymax Corp) is applied to the proximal end of the outer catheter body 16, and the outer catheter body 16 is inserted into the handle 14. The adhesive joint is cured under UV light for an appropriate time period, e.g., 15 seconds. This secures the outer catheter body 16 and attached structure 56 to the handle 14.
  • [0088]
    2. Assembling The Inner Catheter Body
  • [0089]
    In a representative embodiment, the inner catheter body 18 comprises an extruded tube, made from 25% TEXIN® 5286 Material and 75% TEXIN® 5270 Material. The TEXIN® materials can be purchased in pellet form from Bayer.
  • [0090]
    The inner catheter body 18 can be extruded in a tubular shape using, e.g., a screw type (888 4:1) extrusion machine, with a GENCA™ head, with a 80-100-200 screen. The following table summarizes representative process settings for the extrusion.
    Extrusion Element Nominal Setting
    Die 0.195″
    Mandrel 0.135″
    Zone 1 Set/Actual 360 degrees F.
    Zone 2 Set/Actual 380 degrees F.
    Zone 3 Set/Actual 490 degrees F.
    Clamp Set/Actual 400 degrees F.
    Adaptor Set/Actual 400 degrees F.
    Die 1 Set/Actual 400 degrees F.
    Die 2 Set/Actual 400 degrees F.
    Extruder 30.7 RPM
    Motor In. 3300 Auto/Dis. 1772
    Mandrel Air 1 PSI
    Entry Hole Diameter - 300-1″
    Distribution
    Water Flow/Temperature 20 ccm
    Air Wipe 20 PSI
    Speed 87 FPM
    Min Dryer Time/Temperature Overnight/160 degrees F.
  • [0091]
    The extrusion is initially cut to lengths of 16″ for assembly. Like the outer catheter body 16, the inner catheter body 18 is preferably subject to heat annealing.
  • [0092]
    After annealing, the flared region 52 is formed using a 0.099″ stylet heated by a heat gun. One possible setting of the heat gun is 200 degrees C. After cooling, UV adhesive is applied to secure the flared region 52 to the second luer fitting 34, which, at this stage of assembly, is not yet connected to the handle 14. The adhesive is cured under UV light for an appropriate time period.
  • [0093]
    In the illustrated embodiment (see FIG. 5), fluoroscopic marker bands 72 are secured on the inner catheter body 18. The marker bands 72 facilitate fluoroscopic visualization of the proximal and distal ends of the structure 56 on the distal end of the tool 48. In the illustrated embodiment, the marker bands 72 are made from platinum/iridium material (commercially available from Johnson Matthey).
  • [0094]
    In a representative embodiment, the marker bands 72 are located on the inner catheter body 18 about 1 mm beyond the distal end of the outer catheter body 16 and also distally about 10.6 mm from the center of the structure 56. Prior to attaching the marker bands 72, the inner catheter body 18 (stiffened by an appropriate interior support mandrel) is inserted into the outer catheter body 16, so that the desired relative positions of the marker bands 72 can be determined using a reference tool, such as a ruler. The inner catheter body 18 is then removed from outer catheter body 16, and the marker bands 72 are affixed at the indicated positions. The distal tip of inner catheter body 18 can be cut at a 45 degree angle to facilitate slipping the marker bands 72 about the body 18. The marker bands 72 are secured to the inner catheter body 18 using, e.g., a suitable adhesive primer (e.g., Loctite 7701 Primer, which is commercially available from Loctite), followed by use of a suitable adhesive (e.g. Cyanoacrylate 4061, which is commercially available from Loctite). After the adhesive cures, the inner catheter body 18 is inserted into the outer catheter body 16 and the second luer fitting 34 is secured to the handle 14 using an UV adhesive (e.g., 204-CTH Adhesive, commercially available from Dymax). The adhesive is cured by exposure to UV light for an appropriate time period. This secures the inner catheter body 18 to the handle 14.
  • [0095]
    The distal end of the inner catheter body 18 can now be secured to the distal end of the structure 56. During this operation, the dimension of the opening 30 of the inner catheter body 18 is also reduced, to block passage of the stylet 38, as previously described.
  • [0096]
    A first support mandrel (e.g., having an outer diameter of 0.041″) is placed within the inner catheter body 18. A temporary ring of silicone tubing (e.g., having an inner diameter of 0.132″) is slid over the junction of the distal end of the structure 56 and the distal end of the inner catheter body 18. Using a heat box, heat is applied to the silicone tubing, which causes the distal end of the stricture 56 to shrink slightly about the inner catheter body 18. This allows a smaller diameter silicone tubing to be used to form the final bond, as will be described later. Using the materials described, the heat box is set at a temperature of 525 degrees F., an air flow of 30 SCFH, and an air pressure of 20 to 30 psi. Exposure to heat desirably occurs for 16 seconds, with the assembly rotated 180 degrees after the first eight seconds.
  • [0097]
    The first support mandrel is then removed, and a reduced diameter stylet (e.g., having an outside diameter of 0.008″) is inserted into the inner catheter body 18. A smaller diameter silicone tubing 74 (made, e.g., from silicone tubing having a initial inner diameter of 0.078″) (see FIG. 5) is slid over the junction for final bonding of the structure 56 to the inner catheter body 18. Heat from the above-described heat box is then applied for 30 seconds to each side of the assembly. The structure-tubing interface is allowed to cool. The distal end of the structure 56 is trimmed, e.g., to a 3 mm length.
  • [0098]
    As a result of these processing steps, the inside diameter of the opening 30 is desirably reduced to a diameter that approximates the outside diameter of the reduced diameter stylet (e.g., 0.008″). This diameter is significantly smaller than the outside diameter of the stylet 38, which in the representative embodiment is 0.038″. The reduced diameter of the opening 30 blocks passage of the stylet 38. Still, the reduced diameter of the opening 30 allows flushing liquid to be discharged.
  • [0099]
    The stylet 38 can now be inserted into the inner catheter body 18, with the distal end flush against the distal bond. The proximal end of the stylet 38 is secured by UV-cured adhesive (e.g., 198-M Adhesive, commercially available from Dymax) to the screw cap 50. The cap 50 can now be screwed upon the second luer fitting 34 of the handle 14.
  • [0100]
    A cut length of tubing made of Pebax™ material (e.g., 0.160 inch interior diameter) is flared at each end, using, e.g., a heat gun with a flare nozzle. This forms the insertion sleeve 54. The insertion sleeve 54 is slid over the structure 56 and onto the outer catheter body 16.
  • [0101]
    This completes the assembly of the tool 48. The tool 48 can then be packaged for sterilization in a suitable kit. If desired, the stylet 38 can be packaged next to the tool 48 to facilitate ETO sterilization, and be inserted into the inner catheter body 18 in the manner described at the time of use.
  • [0102]
    III. Use of the Tool
  • [0103]
    A. Deployment in a Vertebral Body
  • [0104]
    The structure 56 is well suited for insertion into bone in accordance with the teachings of U.S. Pat. Nos. 4,969,888 and 5,108,404, which are incorporated herein by reference.
  • [0105]
    For example, as FIG. 9 shows, access can be accomplished, for example, by drilling an access portal 76 through a side of the vertebral body 26. This is called a lateral approach. Alternatively, the access portal can pass through either pedicle 42, which called a transpedicular approach. A hand held tool can be used to facilitate formation of the access portal 76, such as disclosed in copending U.S. patent application Ser. No. 09/421,635, filed Oct. 19, 1999, and entitled “Hand Held Instruments that Access Interior Body Regions.” Another hand held tool that can be used to form the access portal 76 and gain access is disclosed in copending U.S. patent application Ser. No. 09/014,229 filed Jan. 27, 1998 and entitled “A Slip-Fit Handle for Hand-Held Instruments that Access Interior Body Regions.”
  • [0106]
    A guide sheath or cannula 78 is placed into communication with the access portal 76, which can comprise a component part of the hand held tool just described. The catheter tube assembly 10 is advanced through the cannula 78 to deploy the structure 56 into contact with cancellous bone 32. Access in this fashion can be accomplished using a closed, minimally invasive procedure or with an open procedure.
  • [0107]
    The structure 56 is passed into the bone in a normally collapsed and not inflated condition. The presence of the stylet 38 in the inner catheter body 18 serves to keep the structure 56 in the desired distally straightened condition during its passage through the cannula 78. The insertion sleeve 54 is desirably advanced over the structure 56 prior to insertion into the cannula 78, to protect and compress the structure 56. Once deployed in cancellous bone 32, the stylet 38 can be withdrawn.
  • [0108]
    As FIG. 9 shows, expansion of the structure 56 (indicated by arrows in FIG. 9) compresses cancellous bone 32 in the vertebral body 26. The compression forms an interior cavity 80 in the cancellous bone 32.
  • [0109]
    As FIG. 10 shows, subsequent collapse and removal of the structure 56 leaves the cavity 80 in a condition to receive a filling material 88, e.g., bone cement, allograft tissue, autograft tissue, hydroxyapatite, or synthetic bone substitute. The material 88 provides improved interior structural support for cortical bone 32.
  • [0110]
    The compaction of cancellous bone 32, as shown in FIG. 9, can also exert an interior force upon the surrounding cortical bone 28. The interior force can elevate or push broken and compressed bone back to or near its original prefracture, or other desired, condition. In the case of a vertebral body 26, deterioration of cancellous bone 32 can cause the top and bottom plates (designated TP and BP in FIG. 2), as well as the side walls (designated AW and PW in FIG. 2), to compress, crack, or move closer together, reducing the normal physiological distance between some or all of the plates. In this circumstance, the interior force exerted by the structure 56 as it compacts cancellous bone 32 moves some or all of the plates and/or walls farther apart, to thereby restore some or all of the spacing between them, which is at or close to the normal physiological distance.
  • [0111]
    There are times when a lesser amount of cancellous bone compaction is indicated. For example, when the bone disease being treated is localized, such as in avascular necrosis, or where local loss of blood supply is killing bone in a limited area, an expandable structure 56 can compact a smaller volume of total bone. This is because the diseased area requiring treatment is smaller.
  • [0112]
    Another exception lies in the use of an expandable structure 56 to improve insertion of solid materials in defined shapes, like hydroxyapatite and components in total joint replacement. In these cases, the structure shape and size is defined by the shape and size of the material being inserted.
  • [0113]
    Yet another exception lies in the use of expandable structures in bones to create cavities to aid in the delivery of therapeutic substances, as disclosed in copending U.S. patent application Ser. No. 08/485,394, previously mentioned. In this case, the cancellous bone may or may not be diseased or adversely affected. Healthy cancellous bone can be sacrificed by significant compaction to improve the delivery of a drug or growth factor which has an important therapeutic purpose. In this application, the size of the expandable structure 56 is chosen by the desired amount of therapeutic substance sought to be delivered.
  • [0114]
    It should be understood that the filling material 88 itself could be used to expand the structure 56 within the vertebral body 26, thereby causing compaction of the cancellous bone 32 and/or movement of the cortical bone 28 as previously described. If desired, the filling material 88 within the structure 56 could be allowed to harden, and the structure 56 and hardened filling material 88 could remain within the vertebral body 26. This would significantly reduce the possibility of non-hardened filling material 88 leaking outside of the vertebral body 26. Alternatively, the pressurized fluid could be withdrawn from the structure 56 after formation of some or all of the cavity 80, and filler material 88 could be injected into the structure to fill the cavity 80 and/or complete expansion of the structure 56. As another alternative, filler material 88 could be used to expand the structure 56, and the structure 56 could subsequently be removed from the vertebral body 26 before the filling material 88 within the vertebral body 26 sets to a hardened condition.
  • [0115]
    B. Expansion Characteristics of the Structure
  • [0116]
    In the illustrated embodiment, the structure 56 is created by extruding or molding a tube 60 of a selected polyurethane material. The tube 60 is heated, stretched, and subjected to internal pressure. After stretching and pressure forming, the tube 60 has a normal wall thickness (T5) and a normal outside diameter (D5) (as shown in FIG. 11).
  • [0117]
    The segmented shaped regions 82 and 84 of the structure 56 are created by exposing the tube 86 to heat and positive interior pressure inside the cavity 64. Once formed, the structure 56 possesses, in an open air environment, a normal expanded shape, having diameter D7 (shown in phantom lines in FIG. 11). The normal shape and diameter D7 for the regions 82 and 84 generally correspond with the shape and dimension of the cavity spaces 92 and 94, respectively. When an interior vacuum is drawn, removing air from the structure 56, the structure 56 desirably assumes a substantially collapsed, and not inflated geometry, shown in phantom lines D6 in FIG. 11.
  • [0118]
    The regions 82 and 84 are separated by a tubular waist 86, which segments the structure 56 into two expandable regions 82 and 84. When substantially collapsed under vacuum or not inflated, the structure 56 desirably exhibits a low profile, ideal for insertion into the cannula and targeted cancellous bone region.
  • [0119]
    The introduction of fluid volume back into the structure 56 will cause each region 82 and 84 to return from the collapsed diameter D6 back to the normal, enlarged, but not distended geometry, having the shape and diameter shown in phantom lines D7 in FIG. 11.
  • [0120]
    In the illustrated embodiment, the first and second shaped regions 82 and 84 have generally the same radius of expansion and thus the same non-distended shape and diameter D7. Alternatively, each region 82 and 84 can have a different radius of expansion, and thus a different non-distended shape and diameter. Moreover, the regions 82 and 84 can be shaped by heat and interior pressure within different cavities to assume different geometries, e.g., cylindrical or elliptical geometry, or a non-spherical, non-cylindrical, or non-elliptical geometry, with either uniform or complex curvature, and in either symmetric or asymmetric forms. Of course, more than two segmented regions 82 and 84 can be formed.
  • [0121]
    Each shaped region 82 and 84 possesses a wall thickness (designed T7 in FIG. 11) when in the normally enlarged but not distended geometry D7. Due to expansion of the wall during structure formation, the wall thickness is typically not uniform along the longitudinal axis of the structure 56, i.e., T7 is typically less than the normal wall thicknesses T5 and/or T9 of the tube 60. The wall thickness T7 for the regions 82 and 84 can be the same or different.
  • [0122]
    When in the enlarged, but not distended geometry, the waist region 86 has an outside diameter (designated D9 in FIG. 11), which is desirably equal to or greater than the diameter D5 of the tube 60. The size of the channel 96 in the fixture 90 desirably determines the magnitude of the diameter D9. Due to expansion of the material during structure formation, the waist region 86 has a wall thickness (designated T9 in FIG. 11) which is less than or equal to the wall thickness T5 of the tube 60. Desirably, the wall thickness T9 of the waist region 86 is greater than the wall thickness T7 of either fully shaped region 82 or 84.
  • [0123]
    The formed complex structure 56 thus desirably possesses regions of non-uniform minimum wall thickness along its longitudinal length; that is, T5, T9>T7. The formed complex structure 56 also provides multiple expandable regions 82 and 84 of the same or different enlarged outside diameters (D7), segmented by a waist region 86.
  • [0124]
    By injecting additional fluid into the expandable structure 56, the shaped regions 82 and 84 of the structure 56 will desirably continue to enlarge beyond diameter D7 to a distended shape and geometry, designated D8 in FIG. 11. Typically, the wall thickness T7 further decreases and approaches T8. As the regions 82 and 84 expand, the waist region 86 will likewise expand towards diameter D10, as FIG. 11 shows. However, because the wall thickness T9 of the waist region 86 is typically greater than the wall thickness T7 of the regions 82 and 84, the waist region 86 will typically expand more slowly than the regions 82 and 84, thereby expanding the structure 56 in a more cylindrical manner, providing more uniform, elongated surface contact with cancellous bone than would a spherical expandable structure 56 of similar volume.
  • [0125]
    Enlargement of the structure 56 beyond diameter D7 desirably stretches the material in the regions 82, 84, and 86 beyond their pre-formed geometries. Desirably, these regions 82 and 84 will essentially maintain the preformed shape dictated by the cavities 92 and 94. Continued volume flow of pressurized fluid into the structure 56 continues to increase the interior volume of the structure 56 (see FIG. 12). As their volume increase, the shaped regions 82 and 84 of the structure 56 continue to enlarge beyond the normal diameter D7 toward a distended shape and geometry D8.
  • [0126]
    Of course, it should be understood that the waist region 86 could be formed of a material having different expansion characteristics than the material of the shaped regions 82 and 84, wherein a more expansion-resistant material could constrain the expansion of the waist region in a manner similar to the thickness differentials described above.
  • [0127]
    The degree of stretching and increases in volume can be tailored to achieve a desired, fully distended diameter D8. The final, fully distended diameter D8 can be selected by the treating physician, using real-time monitoring techniques, such as fluoroscopy or real-time MRI, to match the dimensions of the targeted cancellous bone region. The controlled stretching of the segmented regions 82 and 84 desirably provides compression of cancellous bone with a maximum diameter that is less than a single non-segmented region (i.e., one without the waist region 86). Stated another way, segmented regions 82 and 84, when expanded to a given inflation volume, desirably have an outer diameter less than a sphere expanded to an equal inflation volume.
  • [0128]
    While expanding in the region between D7 and D8, the structure 56, when inside bone, desirably assumes an increasingly larger surface and volume, thereby compacting surrounding cancellous bone. Inflation in cancellous bone may occur at the same pressures as outside bone. However, an increase in the inflation pressures inside bone may be required, due to the density of the cancellous bone and resistance of the cancellous bone to compaction.
  • [0129]
    For example, the configuration of the Pressure vs. Volume curve for a given material and structure 56 remains essentially the same as shown in FIG. 12, except that the generally horizontal portion of the curve between D7 and D8 is shifted upward on the Y-axis, as shown in phantom lines in FIG. 12. As a general statement, the threshold pressure inside bone is determined by the material property of the structure 56 and any added resistance due to the presence of cancellous bone.
  • [0130]
    The distance between D7 and D8, along the x-axis of FIG. 12, defines the degree to which the wall can elongate at a substantially constant pressure condition and with increasing material stress to compact cancellous bone, without failure. As volume increases at the substantially constant threshold pressure P(t), wall failure becomes more likely as the diameter of the structure enlarges significantly further beyond the distended diameter D8. There comes a point when the structure 56 can no longer increase its volume as the material elasticity approaches ultimate elongation, or as material stress approaches ultimate tensile strength. When either of these ultimate values are reached, wall failure is likely. Accordingly, the distance between D7 and D8 in FIG. 12 during expansion inside bone is a simultaneous expression of the three physical and mechanical properties—expansion, shape, and toughness—as previously described.
  • [0131]
    The features of the invention are set forth in the following claims.
Patent Citations
Cited PatentFiling datePublication dateApplicantTitle
US702789 *Mar 20, 1902Jun 17, 1902Charles Gordon GibsonDilator.
US2849002 *Mar 12, 1956Aug 26, 1958Vincent J OddoHaemostatic catheter
US3154077 *Jun 4, 1962Oct 27, 1964Joseph P CannonHemostatic device for anal surgery
US3640282 *Aug 6, 1970Feb 8, 1972Carolyn J WilkinsonTracheal tube with normally expanded balloon cuff
US3648294 *Feb 4, 1970Mar 14, 1972Shahrestani EsfandiarEndoprostheses, especially for hip joints
US3850176 *Oct 9, 1973Nov 26, 1974G GottschalkNasal tampon
US3875595 *Apr 15, 1974Apr 8, 1975Froning Edward CIntervertebral disc prosthesis and instruments for locating same
US3889685 *Nov 2, 1973Jun 17, 1975Cutter LabTubular unit with vessel engaging cuff structure
US4083369 *Jul 2, 1976Apr 11, 1978Manfred SinnreichSurgical instruments
US4261339 *Mar 6, 1978Apr 14, 1981Datascope Corp.Balloon catheter with rotatable support
US4292974 *Jan 30, 1980Oct 6, 1981Thomas J. FogartyDilatation catheter apparatus and method
US4299226 *Aug 8, 1979Nov 10, 1981Banka Vidya SCoronary dilation method
US4302855 *Apr 27, 1979Dec 1, 1981Swanson Alfred BPlug for the intramedallary canal of a bone and method
US4313434 *Oct 17, 1980Feb 2, 1982David SegalFracture fixation
US4327736 *Nov 20, 1979May 4, 1982Kanji InoueBalloon catheter
US4338942 *Oct 20, 1980Jul 13, 1982Fogarty Thomas JDilatation catherter apparatus
US4402307 *Oct 31, 1980Sep 6, 1983Datascope Corp.Balloon catheter with rotatable energy storing support member
US4467790 *Jun 6, 1983Aug 28, 1984Peter SchiffPercutaneous balloon
US4483340 *Oct 20, 1980Nov 20, 1984Thomas J. FogartyDilatation catheter
US4531512 *Jan 4, 1984Jul 30, 1985Datascope CorporationWrapping system for intra-aortic balloon utilizing a wrapping envelope
US4705510 *Oct 17, 1986Nov 10, 1987The Kendall CompanyNephrostomy catheter with formed tip
US4772287 *Aug 20, 1987Sep 20, 1988Cedar Surgical, Inc.Prosthetic disc and method of implanting
US4848344 *Nov 13, 1987Jul 18, 1989Cook, Inc.Balloon guide
US4917088 *Jan 30, 1989Apr 17, 1990C. R. Bard, Inc.Balloon dilation probe
US4969888 *Feb 9, 1989Nov 13, 1990Arie ScholtenSurgical protocol for fixation of osteoporotic bone using inflatable device
US4983167 *Nov 23, 1988Jan 8, 1991Harvinder SahotaBalloon catheters
US5019042 *Apr 18, 1990May 28, 1991Harvinder SahotaBalloon catheters
US5090957 *Oct 9, 1990Feb 25, 1992Abiomed, Inc.Intraaortic balloon insertion
US5102390 *May 2, 1985Apr 7, 1992C. R. Bard, Inc.Microdilatation probe and system for performing angioplasty in highly stenosed blood vessels
US5104376 *Dec 29, 1989Apr 14, 1992C. R. Bard, Inc.Torsionally rigid balloon dilatation probe
US5108404 *Aug 15, 1990Apr 28, 1992Arie ScholtenSurgical protocol for fixation of bone using inflatable device
US5116305 *Oct 23, 1991May 26, 1992Abiomed, Inc.Curved intra aortic balloon with non-folding inflated balloon membrane
US5254091 *Jan 8, 1991Oct 19, 1993Applied Medical Resources CorporationLow profile balloon catheter and method for making same
US5295994 *Nov 15, 1991Mar 22, 1994Bonutti Peter MActive cannulas
US5352199 *May 28, 1993Oct 4, 1994Numed, Inc.Balloon catheter
US5415635 *Jul 21, 1992May 16, 1995Advanced Cardiovascular Systems, Inc.Balloon assembly with separately inflatable sections
US5439447 *Nov 3, 1994Aug 8, 1995Baxter International Inc.Balloon dilation catheter with hypotube
US5468245 *Feb 3, 1994Nov 21, 1995Vargas, Iii; Joseph H.Biomedical cement bonding enhancer
US5480400 *Oct 1, 1993Jan 2, 1996Berger; J. LeeMethod and device for internal fixation of bone fractures
US5549679 *Mar 1, 1995Aug 27, 1996Kuslich; Stephen D.Expandable fabric implant for stabilizing the spinal motion segment
US5587125 *Aug 15, 1994Dec 24, 1996Schneider (Usa) Inc.Non-coextrusion method of making multi-layer angioplasty balloons
US5620457 *Nov 23, 1994Apr 15, 1997Medinol Ltd.Catheter balloon
US5728063 *Nov 24, 1995Mar 17, 1998Micro International Systems, Inc.High torque balloon catheter
US5749888 *Jun 7, 1995May 12, 1998Yock; Paul G.Method of using angioplasty apparatus facilitating rapid exchanges
US5766151 *Jun 7, 1995Jun 16, 1998Heartport, Inc.Endovascular system for arresting the heart
US5782740 *Aug 29, 1996Jul 21, 1998Advanced Cardiovascular Systems, Inc.Radiation dose delivery catheter with reinforcing mandrel
US5827298 *Nov 17, 1995Oct 27, 1998Innovasive Devices, Inc.Surgical fastening system and method for using the same
US5938582 *Sep 26, 1997Aug 17, 1999Medtronic, Inc.Radiation delivery centering catheter
US5951514 *Jun 23, 1998Sep 14, 1999Sahota; HarvinderMulti-lobe perfusion balloon
US5954728 *Mar 30, 1998Sep 21, 1999Sulzer Orthopaedie AgFilling apparatus for bone cement
US5972015 *Aug 15, 1997Oct 26, 1999Kyphon Inc.Expandable, asymetric structures for deployment in interior body regions
US6048346 *Aug 13, 1997Apr 11, 2000Kyphon Inc.Systems and methods for injecting flowable materials into bones
US6066154 *Jan 22, 1997May 23, 2000Kyphon Inc.Inflatable device for use in surgical protocol relating to fixation of bone
US6235043 *Jan 23, 1997May 22, 2001Kyphon, Inc.Inflatable device for use in surgical protocol relating to fixation of bone
US6241734 *Aug 14, 1998Jun 5, 2001Kyphon, Inc.Systems and methods for placing materials into bone
US6248110 *Jun 9, 1997Jun 19, 2001Kyphon, Inc.Systems and methods for treating fractured or diseased bone using expandable bodies
US6379373 *Sep 3, 1999Apr 30, 2002Confluent Surgical, Inc.Methods and apparatus for intraluminal deposition of hydrogels
US6383212 *Dec 11, 2000May 7, 2002Advanced Cardiovascular Systems, Inc.Balloon catheter and stent deploying catheter system
US6423083 *Apr 13, 1998Jul 23, 2002Kyphon Inc.Inflatable device for use in surgical protocol relating to fixation of bone
US6623505 *Jul 31, 2001Sep 23, 2003Kyphon Inc.Expandable structures for deployment in interior body regions
US6852095 *Jul 9, 1998Feb 8, 2005Charles D. RayInterbody device and method for treatment of osteoporotic vertebral collapse
US20050119662 *Oct 5, 2004Jun 2, 2005Kyphon Inc.Systems and methods for treating fractured or diseased bone using expandable bodies
US20080065137 *Oct 30, 2007Mar 13, 2008Kyphon, Inc.Expandable structures for deployment in interior body regions
USD439980 *Oct 19, 1999Apr 3, 2001Kyphon, Inc.Hand-held surgical instrument
Referenced by
Citing PatentFiling datePublication dateApplicantTitle
US7666226Aug 15, 2006Feb 23, 2010Benvenue Medical, Inc.Spinal tissue distraction devices
US7666227Feb 23, 2010Benvenue Medical, Inc.Devices for limiting the movement of material introduced between layers of spinal tissue
US7670374Mar 2, 2010Benvenue Medical, Inc.Methods of distracting tissue layers of the human spine
US7670375Aug 15, 2006Mar 2, 2010Benvenue Medical, Inc.Methods for limiting the movement of material introduced between layers of spinal tissue
US7753941Jul 13, 2010Anulex Technologies, Inc.Devices and methods for annular repair of intervertebral discs
US7785368Aug 31, 2010Benvenue Medical, Inc.Spinal tissue distraction devices
US7846171Dec 7, 2010C.R. Bard, Inc.Method and apparatus for delivering a prosthetic fabric into a patient
US7875035Jan 25, 2011Kyphon SarlExpandable structures for deployment in interior body regions
US7905923Mar 15, 2011Anulex Technologies, Inc.Devices and methods for annular repair of intervertebral discs
US7955391Feb 15, 2010Jun 7, 2011Benvenue Medical, Inc.Methods for limiting the movement of material introduced between layers of spinal tissue
US7963993Feb 15, 2010Jun 21, 2011Benvenue Medical, Inc.Methods of distracting tissue layers of the human spine
US7967864Feb 15, 2010Jun 28, 2011Benvenue Medical, Inc.Spinal tissue distraction devices
US7967865Feb 15, 2010Jun 28, 2011Benvenue Medical, Inc.Devices for limiting the movement of material introduced between layers of spinal tissue
US8057544Aug 15, 2006Nov 15, 2011Benvenue Medical, Inc.Methods of distracting tissue layers of the human spine
US8066713Nov 29, 2011Depuy Spine, Inc.Remotely-activated vertebroplasty injection device
US8142462May 27, 2005Mar 27, 2012Cavitech, LlcInstruments and methods for reducing and stabilizing bone fractures
US8221420Jul 17, 2012Aoi Medical, Inc.Trauma nail accumulator
US8221440Nov 8, 2010Jul 17, 2012C.R. Bard, Inc.Method and apparatus for delivering a prosthetic fabric into a patient
US8333773Aug 30, 2007Dec 18, 2012Depuy Spine, Inc.Remotely-activated vertebroplasty injection device
US8353911Jan 15, 2013Aoi Medical, Inc.Extendable cutting member
US8360629Jan 29, 2013Depuy Spine, Inc.Mixing apparatus having central and planetary mixing elements
US8361078Jan 29, 2013Depuy Spine, Inc.Methods, materials and apparatus for treating bone and other tissue
US8365758Oct 30, 2009Feb 5, 2013Angels' Share Innovations, LLC.Beverage barrel bladder system and apparatus
US8366773Feb 5, 2013Benvenue Medical, Inc.Apparatus and method for treating bone
US8415407Feb 22, 2006Apr 9, 2013Depuy Spine, Inc.Methods, materials, and apparatus for treating bone and other tissue
US8454617Jun 4, 2013Benvenue Medical, Inc.Devices for treating the spine
US8535327Mar 16, 2010Sep 17, 2013Benvenue Medical, Inc.Delivery apparatus for use with implantable medical devices
US8540722Jun 16, 2009Sep 24, 2013DePuy Synthes Products, LLCMethods, materials and apparatus for treating bone and other tissue
US8556978Nov 15, 2011Oct 15, 2013Benvenue Medical, Inc.Devices and methods for treating the vertebral body
US8562634Feb 24, 2012Oct 22, 2013Cavitech, LlcInstruments and methods for reducing and stabilizing bone fractures
US8579908Sep 22, 2004Nov 12, 2013DePuy Synthes Products, LLC.Device for delivering viscous material
US8591583Feb 21, 2008Nov 26, 2013Benvenue Medical, Inc.Devices for treating the spine
US8708955Jun 2, 2009Apr 29, 2014Loma Vista Medical, Inc.Inflatable medical devices
US8734387Jan 13, 2012May 27, 2014Warsaw Orthopedic, Inc.Expansion device for treatment of black triangle disease and method
US8801787Jun 16, 2011Aug 12, 2014Benvenue Medical, Inc.Methods of distracting tissue layers of the human spine
US8808376Mar 25, 2009Aug 19, 2014Benvenue Medical, Inc.Intravertebral implants
US8809418Mar 11, 2013Aug 19, 2014DePuy Synthes Products, LLCMethods, materials and apparatus for treating bone and other tissue
US8814873Jun 22, 2012Aug 26, 2014Benvenue Medical, Inc.Devices and methods for treating bone tissue
US8882836Dec 18, 2012Nov 11, 2014Benvenue Medical, Inc.Apparatus and method for treating bone
US8950929Oct 18, 2007Feb 10, 2015DePuy Synthes Products, LLCFluid delivery system
US8956368Aug 27, 2013Feb 17, 2015DePuy Synthes Products, LLCMethods, materials and apparatus for treating bone and other tissue
US8961516Sep 13, 2012Feb 24, 2015Sonoma Orthopedic Products, Inc.Straight intramedullary fracture fixation devices and methods
US8961609Sep 26, 2013Feb 24, 2015Benvenue Medical, Inc.Devices for distracting tissue layers of the human spine
US8968408Apr 24, 2013Mar 3, 2015Benvenue Medical, Inc.Devices for treating the spine
US8974487 *Apr 24, 2009Mar 10, 2015Aneuclose LlcAneurysm occlusion device
US8979929Jun 16, 2011Mar 17, 2015Benvenue Medical, Inc.Spinal tissue distraction devices
US8992541Nov 27, 2013Mar 31, 2015DePuy Synthes Products, LLCHydraulic device for the injection of bone cement in percutaneous vertebroplasty
US9044338Mar 12, 2013Jun 2, 2015Benvenue Medical, Inc.Spinal tissue distraction devices
US9060820Sep 13, 2012Jun 23, 2015Sonoma Orthopedic Products, Inc.Segmented intramedullary fracture fixation devices and methods
US9066808Feb 20, 2009Jun 30, 2015Benvenue Medical, Inc.Method of interdigitating flowable material with bone tissue
US9155574Sep 28, 2009Oct 13, 2015Sonoma Orthopedic Products, Inc.Bone fixation device, tools and methods
US9186194Feb 5, 2015Nov 17, 2015DePuy Synthes Products, Inc.Hydraulic device for the injection of bone cement in percutaneous vertebroplasty
US9186488Jun 2, 2009Nov 17, 2015Loma Vista Medical, Inc.Method of making inflatable medical devices
US9220554Feb 18, 2010Dec 29, 2015Globus Medical, Inc.Methods and apparatus for treating vertebral fractures
US9259250Apr 11, 2013Feb 16, 2016Sonoma Orthopedic Products, Inc.Fracture fixation device, tools and methods
US9259326Nov 21, 2014Feb 16, 2016Benvenue Medical, Inc.Spinal tissue distraction devices
US9259696Aug 10, 2012Feb 16, 2016DePuy Synthes Products, Inc.Mixing apparatus having central and planetary mixing elements
US9289943 *Aug 2, 2011Mar 22, 2016HALDOR Advanced Technologies L.T.DApparatus and method for attaching an RF tag to a sponge item
US9314252Aug 15, 2014Apr 19, 2016Benvenue Medical, Inc.Devices and methods for treating bone tissue
US9326799 *Jul 15, 2011May 3, 2016Globus Medical, Inc.Methods and apparatus for treating vertebral fractures
US9326866Nov 8, 2013May 3, 2016Benvenue Medical, Inc.Devices for treating the spine
US9351779 *Jan 25, 2013May 31, 2016Kyphon SÀRLExpandable device and methods of use
US9381024Sep 28, 2006Jul 5, 2016DePuy Synthes Products, Inc.Marked tools
US20020058947 *Feb 27, 2001May 16, 2002Stephen HochschulerMethod and apparatus for treating a vertebral body
US20040193171 *Mar 31, 2003Sep 30, 2004Depuy Acromed, Inc.Remotely-activated vertebroplasty injection device
US20040267269 *Apr 5, 2004Dec 30, 2004Middleton Lance M.Tissue cavitation device and method
US20050070915 *Sep 22, 2004Mar 31, 2005Depuy Spine, Inc.Device for delivering viscous material
US20060079905 *Aug 1, 2005Apr 13, 2006Disc-O-Tech Medical Technologies Ltd.Methods, materials and apparatus for treating bone and other tissue
US20060084994 *Nov 22, 2005Apr 20, 2006Anulex Technologies, Inc.Devices and methods for the treatment of spinal disorders
US20060155296 *Jan 9, 2006Jul 13, 2006Celonova Biosciences, Inc.Three-dimensional implantable bone support
US20070032567 *Jul 31, 2006Feb 8, 2007Disc-O-Tech MedicalBone Cement And Methods Of Use Thereof
US20070055265 *Aug 15, 2006Mar 8, 2007Laurent SchallerDevices For Limiting the Movement Of Material Introduced Between Layers Of Spinal Tissue
US20070055271 *Aug 15, 2006Mar 8, 2007Laurent SchallerSpinal Tissue Distraction Devices
US20070055273 *Aug 15, 2006Mar 8, 2007Laurent SchallerMethods of Distracting Tissue Layers of the Human Spine
US20070055275 *Aug 15, 2006Mar 8, 2007Laurent SchallerMethods for Limiting the Movement of Material Introduced Between Layers of Spinal Tissue
US20070123877 *Nov 15, 2006May 31, 2007Aoi Medical, Inc.Inflatable Device for Restoring Anatomy of Fractured Bone
US20070213641 *Feb 8, 2006Sep 13, 2007Sdgi Holdings, Inc.Constrained balloon disc sizer
US20070232905 *Apr 4, 2006Oct 4, 2007Francis Tom JUnconstrained Balloon Sizer
US20070233257 *May 25, 2007Oct 4, 2007Anulex Technologies, Inc.Devices and Methods for Annular Repair of Intervertebral Discs
US20080039856 *Aug 30, 2007Feb 14, 2008Depuy Spine, Inc.Remotely-activated vertebroplasty injection device
US20080065137 *Oct 30, 2007Mar 13, 2008Kyphon, Inc.Expandable structures for deployment in interior body regions
US20080097540 *Dec 14, 2007Apr 24, 2008Cvrx, Inc.Ecg input to implantable pulse generator using carotid sinus leads
US20080114364 *Nov 15, 2006May 15, 2008Aoi Medical, Inc.Tissue cavitation device and method
US20080195223 *Nov 1, 2007Aug 14, 2008Avram Allan EddinMaterials and Methods and Systems for Delivering Localized Medical Treatments
US20080200915 *Sep 28, 2006Aug 21, 2008Disc-O-Tech Medical Technologies, Ltd.Marked tools
US20080212405 *Jul 6, 2006Sep 4, 2008Disc-O-Tech Medical Technologies, Ltd.Mixing Apparatus
US20080234827 *Feb 21, 2008Sep 25, 2008Laurent SchallerDevices for treating the spine
US20080255560 *May 20, 2005Oct 16, 2008Myers Surgical Solutions, LlcFracture Fixation and Site Stabilization System
US20080255569 *Mar 2, 2007Oct 16, 2008Andrew KohmBone support device, system, and method
US20080294166 *May 21, 2008Nov 27, 2008Mark GoldinExtendable cutting member
US20080294167 *May 21, 2008Nov 27, 2008Brian SchumacherArticulating cavitation device
US20090131952 *May 21, 2008May 21, 2009Brian SchumacherDelivery system and method for inflatable devices
US20090177207 *Feb 20, 2009Jul 9, 2009Laurent SchallerMethod of interdigitating flowable material with bone tissue
US20090182386 *Jul 16, 2009Laurent SchallerSpinal tissue distraction devices
US20090264892 *Jun 16, 2009Oct 22, 2009Depuy Spine, Inc.Methods, Materials and Apparatus for Treating Bone or Other Tissue
US20090264942 *Jun 16, 2009Oct 22, 2009Depuy Spine, Inc.Methods, Materials and Apparatus for Treating Bone and Other Tissue
US20090270872 *Oct 29, 2009Depuy Spine, Inc.Remotely-activated vertebroplasty injection device
US20090299327 *Jun 2, 2009Dec 3, 2009Lorna Vista Medical, Inc.Inflatable medical devices
US20090301643 *Jun 2, 2009Dec 10, 2009Loma Vista Medical, Inc.Inflatable medical devices
US20090326581 *Mar 23, 2007Dec 31, 2009Geoffrey Harrison GalleyExpandable spacing means for insertion between spinous processes of adjacent vertebrae
US20100099949 *Jul 30, 2009Apr 22, 2010Alexander Quillin TilsonBiological navigation device
US20100168271 *Sep 11, 2007Jul 1, 2010Depuy Spine, IncBone cement and methods of use thereof
US20100174321 *Jul 8, 2010Laurent SchallerMethods of Distracting Tissue Layers of the Human Spine
US20100174375 *Jul 8, 2010Laurent SchallerSpinal Tissue Distraction Devices
US20100241178 *Jun 2, 2009Sep 23, 2010Loma Vista Medical, Inc.Inflatable medical devices
US20110046658 *Apr 24, 2009Feb 24, 2011Aneuclose LlcAneurysm occlusion device
US20110101010 *May 5, 2011Maiocco Mark ATilting rack system
US20110190776 *Dec 20, 2010Aug 4, 2011Palmaz Scientific, Inc.Interosteal and intramedullary implants and method of implanting same
US20110213402 *Sep 1, 2011Kyphon SarlLow-compliance expandable medical device
US20120010713 *Jan 12, 2012O'halloran DamienMethods and Apparatus For Treating Vertebral Fractures
US20130199720 *Aug 2, 2011Aug 8, 2013Reuven HALBERTHALApparatus and method for attaching an rf tag to a sponge item
WO2006074410A2 *Jan 9, 2006Jul 13, 2006Celonova Biosciences, Inc.Three-dimensional implantable bone support
WO2006074410A3 *Jan 9, 2006Oct 18, 2007Celonova Biosciences IncThree-dimensional implantable bone support
WO2009134337A1 *Apr 24, 2009Nov 5, 2009Aneuclose LlcAneurysm occlusion device
Classifications
U.S. Classification606/99, 606/192, 623/908
International ClassificationA61F2/958, A61B17/02, A61B17/00, A61L27/00, A61B17/88, A61B19/00, A61B17/34, A61B17/56, A61F2/44, A61F2/28
Cooperative ClassificationA61B90/39, Y10S606/91, A61M2210/02, A61M2210/1003, A61M25/1011, A61B2017/00557, A61B17/3472, A61M29/02, A61M25/10, A61B17/7097, A61B17/8855, A61B2017/00539, A61B2017/0256, A61B2017/00544, A61M25/002, A61B2017/00526
European ClassificationA61B17/88C2B, A61M29/02, A61M25/00P, A61M25/10, A61B17/70V
Legal Events
DateCodeEventDescription
Feb 5, 2007ASAssignment
Owner name: BANK OF AMERICA, N.A., AS ADMINISTRATIVE AGENT, WA
Free format text: SECURITY AGREEMENT;ASSIGNOR:KYPHON INC.;REEL/FRAME:018875/0574
Effective date: 20070118
Owner name: BANK OF AMERICA, N.A., AS ADMINISTRATIVE AGENT,WAS
Free format text: SECURITY AGREEMENT;ASSIGNOR:KYPHON INC.;REEL/FRAME:018875/0574
Effective date: 20070118
Mar 14, 2008ASAssignment
Owner name: KYPHON, INC., CALIFORNIA
Free format text: TERMINATION/RELEASE OF SECURITY INTEREST;ASSIGNOR:BANK OF AMERICA, N.A.;REEL/FRAME:020666/0869
Effective date: 20071101
Owner name: KYPHON, INC.,CALIFORNIA
Free format text: TERMINATION/RELEASE OF SECURITY INTEREST;ASSIGNOR:BANK OF AMERICA, N.A.;REEL/FRAME:020666/0869
Effective date: 20071101
May 9, 2008ASAssignment
Owner name: MEDTRONIC SPINE LLC, CALIFORNIA
Free format text: CHANGE OF NAME;ASSIGNOR:KYPHON INC;REEL/FRAME:020993/0042
Effective date: 20080118
Owner name: MEDTRONIC SPINE LLC,CALIFORNIA
Free format text: CHANGE OF NAME;ASSIGNOR:KYPHON INC;REEL/FRAME:020993/0042
Effective date: 20080118
Jun 9, 2008ASAssignment
Owner name: KYPHON SARL, SWITZERLAND
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:MEDTRONIC SPINE LLC;REEL/FRAME:021070/0278
Effective date: 20080325
Owner name: KYPHON SARL,SWITZERLAND
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:MEDTRONIC SPINE LLC;REEL/FRAME:021070/0278
Effective date: 20080325
Mar 26, 2015ASAssignment
Owner name: ORTHOPHOENIX, LLC, TEXAS
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:KYPHON SARL;REEL/FRAME:035307/0018
Effective date: 20130425