Source: https://patents.google.com/patent/US20030229372?oq=552685
Timestamp: 2018-03-18 12:03:29
Document Index: 247991554

Matched Legal Cases: ['arts 12', 'arts 12', 'arts 12', 'arts 12', 'arts 12', 'arts 12', 'arts 12', 'art 84', 'art 85', 'arts 84']

US20030229372A1 - Inflatable device for use in surgical protocols relating to treatment of fractured or diseased bone - Google Patents
US20030229372A1
US20030229372A1 US10458235 US45823503A US2003229372A1 US 20030229372 A1 US20030229372 A1 US 20030229372A1 US 10458235 US10458235 US 10458235 US 45823503 A US45823503 A US 45823503A US 2003229372 A1 US2003229372 A1 US 2003229372A1
US10458235
This application is a divisional of copending application Ser. No. 08/799,832, filed Feb. 13, 1997, which is a continuation of application Ser. No. 08/485,394, filed Jun. 7, 1995, now abandoned, which is a continuation-in-part of Ser. No. 08/188,244, filed Jan. 26, 1994, now abandoned.
Therapeutic substances like antibiotics and bone growth factors have not been applied to bone during open surgeries or minimally-invasive procedures in a way open surgeries or minimally-invasive procedures in a way that optimizes and maintains their contact with the desired area of bone. Antibiotics, bone growth factors and other drugs can prevent complications and hasten repair. They are currently placed as dry powders or liquids around the treated bone, or else are formulated into a gel or a degradable plastic polymer and inserted into areas with defects (holes in the bone). Delivered in this manner, they can be washed away by blood or other fluids, either immediately or as their carrier degrades. Also, the amount of therapeutic substance delivered in a gel or polymer can be limited by the space provided by the defect.
The method disclosed in these two patents includes a series of steps which a surgeon or health care provider can perform to form a cavity in fractured or pathological bone (including but not limited to osteoporotic bone, osteoporotic fractured metaphyseal and epiphyseal bone, osteoporotic vertebral bodies, fractured osteoporotic vertebral bodies, fractures of vertebral bodies due to tumors especially round cell tumors, avascular necrosis of the epiphyses of long bones, especially avascular necrosis of the proximal femur, distal femur and proximal humerus and defects arising from endocrine conditions).
While the apparatus and method of the above patents provide an adequate protocol for the fixation of bone, it has been found that the compacting of the bone marrow and/or the trabecular bone and/or cancellous bone against the inner surface of the cortical wall of the bone to be treated can be significantly improved with the use of inflatable devices that incorporate additional engineering features not heretofore described and not properly controlled with prior inflatable devices in such patents. It has also been found that therapeutic substances can be delivered with the apparatus and methods of the above patents in an unexpected way. It has been additionally found that the apparatus and methods of the above patents can be adapted in ways not heretofore described to improve open surgeries to fix, fuse or remove bone, as well as to deliver therapeutic substances during these surgeries. A need has therefore arisen for improvements in the shape, construction and size of inflatable devices for use with the foregoing apparatus and method, as well as for new methods, and the present invention satisfies such need.
U.S. Pat. No. 5,163,989 discloses a mold and technique for molding dilatation catheters in which the balloon of th the balloon of the present invention is especially suitable for forming prism-like balloons, it can also be used for forming balloons of a wide variety of sizes and shapes.e catheter is free of parting lines. The technique involves inflating a plastic member of tubular shape so as to press it against the inner molding surface which is heated. Inflatable devices are molded into the desired size and shape, then cooled and deflated to remove it from the mold. The patent states that, while
The present invention is directed to a balloon-like inflatable device or balloon for use in carrying out the apparatus and method of the above-mentioned U.S. Pat. Nos. 4,969,888 and 5,108,404, and to new methods for using these devices, and to new uses of the methods and devices. Such inflatable devices, hereinafter sometimes referred to as balloons, have shapes for compressing cancellous bone and marrow (also known as medullary bone or trabecular bone) against the inner cortex of bones whether the bones are fractured or not.
Another object of the invention is to provide new uses for these balloons, and new methods for their use. Balloons can be used to deliver therapeutic substances by coating the balloons with the therapeutic substance before inserting the balloon into bone. When coated balloons are inflated in bone, the therapeutic substances are pressed into the cancellous bone while that bone is being compressed by the balloon. This allows desired amounts of the therapeutic substance to be delivered directly to the site of therapy in a manner that is maintained over time. The balloons can also be used during open surgeries to fix, fuse or remove bone to provide an improved space for orthopedic implants, bone graft, bone substitutes, acrylic cements, bone fillers or therapeutic substances.
The methods of the above-mentioned patents and the improvements herein can be applied anywhere in the in the skeleton where there is cancellous and/or trabecular and/or medullary bone.
A primary goal of percutaneous vertebral body augmentation of the present invention is to provide a balloon which can create a cavity inside the vertebral body whose configuration is optimal for supporting the bone. Another important goal is to move the top of the vertebral body back into place to retain height where possible, however, both of these objectives must be achieved without changing the outer diameter of the sides of the vertebral body, either by fracturing the cortical wall of the vertebral body or by moving already fractured bone. This feature could push vertebral bone toward the spinal cord, a condition which is not to be desired.
A primary goal of percutaneous femoral head (or humeral head) augmentation is to create a cavity inside the femoral head (or humeral head) whose configuration is optimal for supporting the femoral head. Another important goal is to help compress avascular (or aseptic necrotic bone or support avascular necrotic bone in the femoral head. This goal may include the realignment of avascular bone back into the position it previously occupied in the femoral head in order to improve the spherical shape of the femoral head. These goals must be achieved by exerting pressure primarily on the cancellous bone inside the femoral head.
[0062]FIG. 1 is a perspective view of a first embodiment of the balloon of the present invention, the embodiment being in the shape of a stacked doughnut assembly;
[0063]FIG. 2 is a vertical section through the balloon of FIG. 1 showing the way in which the doughnut portions of the balloon of FIG. 1, fit into a cavity of a vertebral body;
[0064]FIG. 3 is a schematic view of another embodiment of the balloon of the present invention showing three stacked balloons and string-like restraints for limiting the expansion of the balloon in)directions of inflation;
[0065]FIG. 4 is a top plan view of a spherical balloon having a cylindrical ring surrounding the balloon;
[0066]FIG. 5 is a vertical section through the spherical balloon and ring of FIG. 4;
[0067]FIG. 6 shows an oblong-shaped balloon with a catheter extending into the central portion of the balloon;
[0068]FIG. 6A is a perspective view of the way in which a catheter is arranged relative to the inner tubes for inflating the balloon of FIG. 6;
[0069]FIG. 7 is a suction tube and a contrast injection tube for carrying out the inflation of the balloon and removal of debris caused by expansion from the balloon itself;
[0070]FIG. 8 is a vertical section through a balloon after it has been deflated and as it is being inserted into the vertebral body of a human;
[0071]FIGS. 9 and 9A are side elevational views of a cannula showing how the protective sleeve or guard member expands when leaving the cannula;
[0072]FIG. 9B is a vertical section through a vertebral bone into which an access hole has been drilled;
[0073]FIG. 10 is a perspective view of another embodiment of the balloon of the present invention formed in the shape of a kidney bean;
[0074]FIG. 11 is a perspective view of the vertebral bone showing the kidney shaped balloon of FIG. 10 inserted in the bone and expanded;
[0075]FIG. 12 is a top view of a kidney shaped balloon formed of several compartments by a heating element or branding tool;
[0076]FIG. 13 is a cross-sectional view taken along line 13-13 of FIG. 12 but with two kidney shaped balloons that have been stacked.
[0077]FIG. 14 is a view similar to FIG. 11 but showing the stacked kidney shaped balloon of FIG. 13 in the vertebral bone;
[0078]FIG. 15 is a top view of a kidney balloon showing outer tufts holding inner strings in place interconnecting the top and bottom walls of the balloon;
[0079]FIG. 16 is a cross sectional view taken along lines 16-16 of FIG. 15;
[0080]FIG. 17A is a dorsal view of a humpback banana balloon in a right distal radius;
[0081]FIGS. 17B is a cross sectional view of FIG. 17A taken along line 178-178 of FIG. 17A;
[0082]FIG. 18 is a spherical balloon with a base in a proximal humerus viewed from the front (anterior) of the left proximal humerus;
[0083]FIG. 19A is the front (anterior) view of the proximal tibia with the elliptical cylinder balloon introduced beneath the medial tibial plateau;
[0084]FIG. 19B is a three quarter view of the balloon of FIG. 19A;
[0085]FIG. 19C is a side elevational view of the balloon of FIG. 19A;
[0086]FIG. 19D is a top plan view of the balloon of FIG. 19A;
[0087]FIG. 20 is a spherically shaped balloon for treating avascular necrosis of the head of the femur (or humerus) as seen from the front (anterior) of the left hip; and
[0088]FIG. 20A is a side view of a hemispherically shaped balloon for treating avascular necrosis of the head of the femur (or humerus).
A first embodiment of the balloon (FIG. 1) of the present invention is broadly denoted by the numeral 10 and includes a balloon body 11 having a pair of hollow, inflatable, non-expandable parts 12 and 14 of flexible material, such as PET or Kevlar. Parts 12 and 14 have a suction tube 16 therebetween for drawing fats and other debris by suction into tube 16 for transfer to a remote disposal location. Catheter 16 has one or more suction holes so that suction may be applied to the open end of tube 16 from a suction source (not shown) The parts 12 and 14 are connected together by an adhesive which can be of any suitable type. Parts 12 and 14 are doughnut-shaped as shown in FIG. 1 and have tubes 18 and 20 which communicate with and extend away from the parts 12 and 14, respectively, to a source of inflating liquid under pressure (not shown). The liquid can be any sterile biocompatible solution. The liquid inflates the balloon 10, particularly parts 12 and 14 thereof after the balloon has been inserted in a collapsed condition (FIG. 8) into a bone to be treated, such as a vertebral bone 22 in FIG. 2. The above-mentioned U.S. Pat. Nos. 4,969,888 and 5,108,404 disclose the use of a guide pin and cannula for inserting the balloon into bone to be treated when the balloon is deflated and has been inserted into a tube and driven by the catheter into the cortical bone where the balloon is inflated.
[0091]FIG. 8 shows a deflated balloon 10 being inserted through a cannula 26 into bone. The balloon in cannula 26 is deflated and is forced through the cannula by exerting manual force on the catheter 21 which extends into a passage 28 extending into the interior of the bone. The catheter is slightly flexible but is sufficiently rigid to allow the balloon to be forced into the interior of the bone where the balloon is then inflated by directing fluid into tube 88 whose outlet ends are coupled to respective parts 12 and 14.
In use, balloon 10 is initially deflated and, after the bone to be filled with the balloon has been prepared to receive the balloon with drilling, the deflated balloon is forced into the bone in a collapsed condition through cannula 26. The bone is shown in FIG. 2. The balloon is oriented preferably in the bone such that it allows minimum pressure to be exerted on the bane marrow and/or cancellous bone if there is no fracture or collapse of the bone. Such pressure will compress the bone marrow and/or cancellous bone against the inner wall of the cortical bone, thereby compacting the bone marrow of the bone to be treated and to further enlarge the cavity in which the bone marrow is to be replaced by a biocompatible, flowable bone material.
[0096]FIGS. 6 and 6A show several views of a modified doughnut shape balloon 80 of the type shown in FIGS. 1 and 2, except the doughnut shapes of balloon 80 are not stitched onto one another. In FIG. 6, balloon 80 has a pear-shaped outer convex surface 82 which is made up of a first hollow part 84 and a second hollow part 85. A tube 88 is provided for directing liquid into the two parts along branches 90 and 92 to inflate the parts after the parts have been inserted into the medullary cavity of a bone. A catheter tube 16 is inserted into the space 96 between two parts of the balloon 80. An adhesive bonds the two parts 84 and 85 together at the interface thereof.
[0097]FIG. 6A shows the way in which the catheter tube 16 is inserted into the space or opening 96 between the two parts of the balloon 80.
[0098]FIG. 7 shows tube 88 of which, after directing inflating liquid into the balloon 80, can inject contrast material into the balloon 80 so that x-rays can be taken of the balloon with the inflating material therewithin to determine the proper placement of the balloon. Tube 16 is also shown in FIG. 6, it being attached in some suitable manner to the outer side wall surface of tube 88.
[0102]FIG. 12 shows a balloon 140 which is also kidney shaped and has a tube 142 for directing an inflatable liquid into the tube for inflating the balloon. The balloon is initially a single chamber bladder but the bladder can be branded along curved lines or strips 141 to form attachment lines 144 which take the shape of side-by-side compartments 146 which are kidney shaped as shown in FIG. 13. A similar pattern of strips as in 140 but in straight lines would be applied to a balloon that is square or rectangular. The branding causes a welding of the two sides of the bladder to occur since the material is standard medical balloon material, which is similar to plastic and can be formed by heat.
[0103]FIG. 14 is a perspective view of a vertebral body 147 containing the balloon of FIG. 12, showing a double stacked balloon 140 when it is inserted in vertebral bone 147.
[0104]FIG. 15 is a view similar to FIG. 10 except that tufts 155, which are string-like restraints, extend between and are connected to the side walls 152 of inflatable device 150 and limit the expansion of the side walls with respect to each other, thus rendering the side walls generally parallel with each other. Tube 88 is used to fill the kidney shaped balloon with an inflating liquid in the manner described above.
The tibial fracture is shown in FIG. 19A in which a balloon 180 is placed in one side 182 of a tibia 183.
The balloon, when inflated, compacts the cancellous bone in the layer 184 surrounding the balloon 180. A cross section of the balloon is shown in FIG. 19C wherein the balloon has a pair of opposed sides 185 and 187 which are interconnected by restraints 188 which can be in the form of strings or flexible members of any suitable construction. The main purpose of the restraints is to make the sides 185 and 187 substantially parallel with each other and non-spherical. A tube 190 is coupled to the balloon 180 to direct liquid into and out of the balloon. The ends of the restraints are shown in FIGS. 19B and 19D and denoted by the numeral 191. The balloon is inserted into and taken out of the tibia in the same manner as that described above with respect to the vertebral bone. FIG. 19B shows a substantially circular configuration for the balloon; whereas, FIG. 19D shows a substantially elliptical version of the balloon.
To deliver therapeutic substances, balloons can be dipped in a medical formulation (often a dry powder, liquid or gel) containing a medically effective amount of any desired antibiotic, bone growth factor or other therapeutic agent to coat the balloon with the above-mentioned substance before it is inserted into a bone being treated. Optionally, the balloon can be wholly or partially inflated with air or liquid before the coating is performed. Optionally, the coated balloon can be dried with air or by other means when the applied formulation is wet, such as a liquid or a gel. The balloon is refolded as required and either used immediately or stored, if appropriate and desired. Coated on the balloon, therapeutic substances can be delivered while cancellous bone is being compressed, or with an additional balloon once the cavity is made.
Medically effective amounts of therapeutic substances are defined by their manufacturers or sponsors and are generally in the range of 10 nanograms to 50 milligrams per site, although more or less may be required in a specific case. Typical antibiotics include gentamicin and tobramycin. Typical bone growth factors are members of the Bone Morphogenetic Factor, Osteogenic Protein, Fibroblast Growth Factor, Insulin-Like Growth Factor and Transforming Growth Factor alpha and beta families.
Different sizes and/or shapes of balloons may be used at sites not specified above, such as the jaw bones or the midshaft of the arm and leg bones. However, useful balloons can be designed by the principles of the inventions herein. 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. Ranges of shapes and dimensions are defined by the site to be treated. Precise dimensions for a given patient are determined by X-ray of the site to be treated, the therapeutic goal and safety constraints at the site. For diseased bone, replacement of the most of the cancellous bone is usually desired, so a balloon whose shape and size will compress around 70-90% of the volume of the cancellous bone in the treated region will be chosen. However, balloons that are smaller or larger may be appropriate, particularly where delivery of a therapeutic substance is the main goal. There, the balloon size could be chosen by the desired amount of therapeutic substance, keeping in mind local structures and safety when the balloon is fully inflated.
1. An assembly for delivering a therapeutic substance to a treatment site within bone, the assembly comprising
a balloon carried by the catheter and insertable into bone by means of passing the catheter through the cannula, said balloon comprising a wall having an outer surface and being capable of inflation from a collapsed configuration and being sized in the collapsed configuration for passage along with the catheter through the cannula for insertion into bone, to an expanded configuration which has a predetermined shape and size sufficient for compressing at least a portion of inner cancellous bone and which is restrained while being expanded in the presence of the cancellous bone, and
a therapeutic substance carried on the outer surface of the balloon wall to be incorporated into the cancellous bone by inflation of the balloon.
an applicator for applying the therapeutic substance to the outer surface of the balloon wall.
3. The assembly of claim 2 wherein the applicator comprises a container having a reservoir of the therapeutic substance and a nozzle for dispensing the therapeutic substance onto the outer surface of the balloon wall.
4. The assembly of claim 3 wherein the therapeutic substance is a gel formulation.
5. The assembly of claim 2 wherein the applicator comprises a dry powder dispenser.
6. The assembly of claim 2, wherein the applicator comprises a dispersion device for spraying the therapeutic substance onto the outer surface of the balloon wall.
7. The assembly of claim 6 wherein the therapeutic substance is a powdered medicament.
8. The assembly of claim 1 wherein the therapeutic substance comprises a bone filling material.
9. The assembly of claim 1 wherein the therapeutic substance comprises a bone growth factor.
10. The assembly of claim 1 wherein the therapeutic substance comprises an antibiotic.
11. The assembly of claim 1 wherein the therapeutic substance comprises a gelatin powder.
12. The assembly of claim 11 wherein the therapeutic substance comprises an agent that absorbs body fluid.
13. The assembly of claim 11 wherein the therapeutic substance comprises an agent that inhibits flow of body fluid.
14. The assembly of claim 11 wherein the therapeutic substance comprises a hemostatic agent.
15. The assembly of claim 11 wherein the therapeutic substance is Gelfoam.
16. An assembly as in claim 1 wherein expansion of the balloon in cancellous bone is restrained by selected thickened wall portions of the balloon wall.
17. An assembly as in claim 1 wherein expansion of the balloon in cancellous bone is restrained by an internal restraint formed in the balloon wall.
18. An assembly as in claim 17 wherein the internal restraint comprises a seam in the balloon.
19. An assembly as in claim 17 wherein the internal restraint comprises a meshwork.
20. An assembly as in claim 17 wherein the internal restraint comprises a woven material.
21. An assembly as in claim 17 wherein the internal restraint comprises string.
22. An assembly as in claim 1 wherein expansion of the balloon in cancellous bone is restrained by an external restraint formed in the balloon wall.
23. An assembly as in claim 22 wherein the external restraint comprises a seam in the balloon.
24. An assembly as in claim 22 wherein the external restraint comprises a meshwork.
25. An assembly as in claim 22 wherein the external restraint comprises a woven material.
26. An assembly as in claim 22 wherein the external restraint comprises string.
27. An assembly as in claim 1 wherein the predetermined shape and size of the balloon when in the expanded configuration comprises opposed sides which are restrained to remain essentially flat.
28. An assembly as in claim 1 wherein the cannula is a percutaneous cannula.
US10458235 1994-01-26 2003-06-10 Inflatable device for use in surgical protocols relating to treatment of fractured or diseased bone Abandoned US20030229372A1 (en)
US79983297 true 1997-02-13 1997-02-13
US10458235 US20030229372A1 (en) 1994-01-26 2003-06-10 Inflatable device for use in surgical protocols relating to treatment of fractured or diseased bone
US11450337 US20060235460A1 (en) 1994-01-26 2006-06-12 Cavity formation device
US79983297 Division 1997-02-13 1997-02-13
US20030229372A1 true true US20030229372A1 (en) 2003-12-11
ID=46282419
US10458235 Abandoned US20030229372A1 (en) 1994-01-26 2003-06-10 Inflatable device for use in surgical protocols relating to treatment of fractured or diseased bone
US11450337 Abandoned US20060235460A1 (en) 1994-01-26 2006-06-12 Cavity formation device
US (2) US20030229372A1 (en)
WO2007008984A1 (en) 2005-07-11 2007-01-18 Kyphon, Inc. Systems and methods for inserting biocompatible filler materials in interior body regions
EP2206467A1 (en) * 2007-05-21 2010-07-14 AOI Medical Inc. Device with inflatable member for reducing a vertebral compression fracture and tentacle for delivering bone cement
WO2014121333A1 (en) 2013-02-06 2014-08-14 Sillender Mark Embryo transfer catheter and method
US20060235460A1 (en) 2006-10-19 application