Source: http://www.google.com/patents/US20050149022?dq=6985872
Timestamp: 2017-12-11 16:34:21
Document Index: 552730122

Matched Legal Cases: ['art 1', 'art 2', 'art 1', 'art 2', 'art 1', 'art 2', 'art 1', 'art 2', 'art 1', 'art 2']

Patent US20050149022 - Curable media for implantable medical device - Google Patents
A subcutaneously formed in place orthopedic fixation device is provided, such as for fixation of the spine or other bone or bones. The device comprises an inflatable member, such as a tubular balloon. The balloon is positioned at a treatment site in the body while in a flexible, low crossing profile...http://www.google.com/patents/US20050149022?utm_source=gb-gplus-sharePatent US20050149022 - Curable media for implantable medical device
Publication number US20050149022 A1
Application number US 11/056,971
Also published as CA2510731A1, CN1787785A, CN100588374C, EP1589886A2, US6875212, US8337556, US20040006341, WO2004058045A2, WO2004058045A3
Publication number 056971, 11056971, US 2005/0149022 A1, US 2005/149022 A1, US 20050149022 A1, US 20050149022A1, US 2005149022 A1, US 2005149022A1, US-A1-20050149022, US-A1-2005149022, US2005/0149022A1, US2005/149022A1, US20050149022 A1, US20050149022A1, US2005149022 A1, US2005149022A1
Inventors Samuel Shaolian, George Teitelbaum, Thanh Nguyen, To Pham, Richard Estes
Original Assignee Shaolian Samuel M., Teitelbaum George P., Nguyen Thanh V., Pham To V., Estes Richard H.
Patent Citations (99), Referenced by (165), Classifications (43), Legal Events (2)
US 20050149022 A1
an outer wall, defining a cavity therein; and
a hardenable media within the cavity to form the orthopedic device, said hardenable media comprising a resin and hardener mixture that is substantially cured at a temperature below about 45° C. in about 90 minutes or less;
2. The formed in place orthopedic device of claim 1, wherein said hardenable media comprises an epoxy resin.
3. The formed in place orthopedic device of claim 2, wherein said epoxy resin comprises a total of about 65-75% by weight of one or more diepoxide resins and a total of about 25-35% by weight of one or more amine curing agents.
4. The formed in place orthopedic device of claim 2, wherein said epoxy resin comprises about 45-52% by weight aromatic diepoxide resin, about 19-23% by weight aliphatic diepoxide resin, about 20-29% by weight dialkylamines and about 4-9% cycloalkylamines.
5. The formed in place orthopedic device of claim 4, wherein the aromatic diepoxide resin comprises diglycidyl ether of Bisphenol A or diglycidyl ether of Bisphenol F.
6. The formed in place orthopedic device of claim 4, wherein the aliphatic diepoxide resin comprises one or more alkane diols of glycidyl ether.
7. The formed in place orthopedic device of claim 4, wherein the dialkylamines are according to the formula H2N—R—NH2, wherein R is a branched or unbranched C2-C10 alkyl group.
8. The formed in place orthopedic device of claim 4, wherein the cycloalkylamines are N-aminoalkylpiperazines.
9. The formed in place orthopedic device of claim 4, wherein the aromatic diepoxide resin comprises diglycidyl ether of Bisphenol A, the aliphatic diepoxide resin comprises butane diol of glycidyl ether, the dialkylamine comprises 1,3-diaminopropane, and the cycloalkylamine comprises N-aminoethylpiperazine.
10. The formed in place orthopedic device of claim 1, wherein said hardenable media cures to a hardened form having a static compression bending value (ASTM F1717) of at least 100 lbs.
a hardenable media for inflating said inflatable member, said hardenable media comprising about 45-52% by weight aromatic diepoxide resin, about 19-23% by weight aliphatic diepoxide resin, about 20-29% by weight dialkylamines and about 4-9% cycloalkylamines; and
21. The orthopedic fixation device of claim 20, wherein the aromatic diepoxide resin comprises diglycidyl ether of Bisphenol A or diglycidyl ether of Bisphenol F; the aliphatic diepoxide resin comprises one or more alkane diols of glycidyl ether; the cycloalkylamines are N-aminoalkylpiperazines; and the dialkylamines are according to the formula H2N—R—NH2, wherein R is a branched or unbranched C2-C10 alkyl group.
22. The orthopedic fixation device of claim 21, wherein the aromatic diepoxide resin comprises diglycidyl ether of Bisphenol A, the aliphatic diepoxide resin comprises butane diol of glycidyl ether, the dialkylamine comprises 1,3-diaminopropane, and the cycloalkylamine comprises N-aminoethylpiperazine.
23. The orthopedic fixation device of claim 20, wherein said hardenable media, when cured, has a static compression bending value of at least 100 lbs (ASTM F1717).
24. The orthopedic fixation device of claim 20, wherein the media is substantially cured in about 90 minutes or less.
25. The orthopedic fixation device of claim 20, wherein the media cures at a temperature of about 45° C. or less.
26. A method of forming an orthopedic device at a treatment site within the body of a patient, comprising the steps of:
positioning an outer wall at the treatment site within the patient, the outer wall defining a chamber therein; and
introducing a hardenable media into the chamber, wherein the hardenable media cures from a liquid form to a hardened form having a static compression bending value of at least 90 lbs (ASTM F1717) in about 90 minutes or less.
27. A method of forming an orthopedic device as in claim 26, wherein the positioning step comprises positioning the outer wall between two bone anchors.
28. The method of claim 26, wherein said hardenable media comprises about 45-52% by weight aromatic diepoxide resin, about 19-23% by weight aliphatic diepoxide resin, about 20-29% by weight dialkylamines and about 4-9% cycloalkylamines.
29. The method of claim 28, wherein the aromatic diepoxide resin comprises diglycidyl ether of Bisphenol A or diglycidyl ether of Bisphenol F; the aliphatic diepoxide resin comprises one or more alkane diols of glycidyl ether; the cycloalkylamines are N-aminoalkylpiperazines; and the dialkylamines are according to the formula H2N—R—NH2, wherein R is a branched or unbranched C2-C10 alkyl group.
30. The method of claim 28, wherein the aromatic diepoxide resin comprises diglycidyl ether of Bisphenol A, the aliphatic diepoxide resin comprises butane diol of glycidyl ether, the dialkylamine comprises 1,3-diaminopropane, and the cycloalkylamine comprises N-aminoethylpiperazine.
31. The method of claim 26, wherein the hardenable media cures at temperature below about 45° C.
32. The method of claim 26, wherein the hardenable media has a static compression bending value (ASTM F1717) of at least 150 lbs within 12 hours.
33. A method of stabilizing an orthopedic fracture, comprising:
delivering an orthopedic device comprising an inflatable balloon to the bone; and
inflating said balloon with a hardenable media comprising about 45-52% by weight aromatic diepoxide resin, about 19-23% by weight aliphatic diepoxide resin, about 20-29% by weight dialkylamines and about 4-9% cycloalkylamines;
34. The method of claim 33, wherein the aromatic diepoxide resin comprises diglycidyl ether of Bisphenol A or diglycidyl ether of Bisphenol F; the aliphatic diepoxide resin comprises one or more alkane diols of glycidyl ether; the cycloalkylamines are N-aminoalkylpiperazines; and the dialkylamines are according to the formula H2N—R—NH2, wherein R is a branched or unbranched C2-C10 alkyl group.
35. The method of claim 33, wherein the aromatic diepoxide resin comprises diglycidyl ether of Bisphenol A, the aliphatic diepoxide resin comprises butane diol of glycidyl ether, the dialkylamine comprises 1,3-diaminopropane, and the cycloalkylamine comprises N-aminoethylpiperazine.
36. The method of claim 33, wherein said hardenable media, when cured, has a static compression bending value of at least 100 lbs. (ASTM F1717).
37. The method of claim 33, wherein the media is substantially cured in about 90 minutes or less.
38. The method of claim 33, wherein the media cures at a temperature of about 45° C. or less.
39. A method of stabilizing an orthopedic fracture, comprising:
delivering an orthopedic device comprising an inflatable balloon through the portals; and
inflating said balloon with a liquid curable material;
wherein the inflating step fixes said anchors in relation to one another and the curable material is substantially cured at a temperature below about 45° C. in about 90 minutes or less.
40. The method of claim 39, wherein said curable material comprises about 45-52% by weight aromatic diepoxide resin, about 19-23% by weight aliphatic diepoxide resin, about 20-29% by weight dialkylamines and about 4-9% cycloalkylamines.
41. The method of claim 40, wherein the aromatic diepoxide resin comprises diglycidyl ether of Bisphenol A or diglycidyl ether of Bisphenol F; the aliphatic diepoxide resin comprises one or more alkane diols of glycidyl ether; the cycloalkylamines are N-aminoalkylpiperazines; and the dialkylamines are according to the formula H2N—R—NH2, wherein R is a branched or unbranched C2-C10 alkyl group.
42. The method of claim 40, wherein the aromatic diepoxide resin comprises diglycidyl ether of Bisphenol A, the aliphatic diepoxide resin comprises butane diol of glycidyl ether, the dialkylamine comprises 1,3-diaminopropane, and the cycloalkylamine comprises N-aminoethylpiperazine.
43. The method of claim 39, wherein said hardenable media, when cured, has a static compression bending value of at least 100 lbs. (ASTM F1717).
44. A formed in place medical device, comprising:
a hardenable media within the cavity to form the medical device, said hardenable media comprising a resin and hardener mixture that cures at a temperature below about 45° C. wherein said cured media has a static compression bending value (ASTM F1717) of at least 150 lbs;
wherein the hardenable media is hardened while the device is positioned within the body of a patient to create the formed in place medical device.
This is a continuation-in-part of U.S. patent application Ser. No. 10/161,554, filed on May 31, 2002, which is a continuation-in-part of U.S. patent application Ser. No. 09/976,459, filed on Oct. 10, 2001, which is a continuation-in-part of U.S. patent application Ser. No. 09/943,636, filed on Aug. 29, 2001, which is a continuation-in-part of U.S. patent application Ser. No. 09/747,066, filed on Dec. 21, 2000, which claims priority to U.S. Provisional Patent Application 60/213,385, filed Jun. 23, 2000, entitled “Percutaneous-Interbody Fusion Device,” the contents of each of which are incorporated in their entirety into this disclosure by reference
In accordance with one embodiment, there is provided a formed in place orthopedic device. The device comprises an outer wall, defining a cavity therein and a hardenable media within the cavity to form the orthopedic device, said hardenable media comprising a resin and hardener mixture that is substantially cured at a temperature below about 45° C. in about 90 minutes or less, wherein the hardenable media is hardened while the device is positioned within the body of a patient to create the formed in place orthopedic device.
In accordance with another embodiment, there is provided a method of stabilizing an orthopedic fracture, comprising inserting at least two anchors having portals into a bone, delivering an orthopedic device comprising an inflatable balloon through the portals, and inflating said balloon with a liquid curable material, wherein the inflating step fixes said anchors in relation to one another and the curable material is substantially cured at a temperature below about 45° C. in about 90 minutes or less. In another embodiment, there is provided a formed in place medical device, comprising an outer wall, defining a cavity therein and a hardenable media within the cavity to form the medical device, said hardenable media comprising a resin and hardener mixture that cures at a temperature below about 45° C. wherein said cured media has a static compression bending value (ASTM F1717) of at least 150 lbs wherein the hardenable media is hardened while the device is positioned within the body of a patient to create the formed in place medical device.
In preferred embodiments, the hardenable or curable material comprises about 45-52% by weight aromatic diepoxide resin, about 19-23% by weight aliphatic diepoxide resin, about 20-29% by weight dialkylamines and about 4-9% cycloalkylamines. In an especially preferred embodiment, the aromatic diepoxide resin comprises diglycidyl ether of Bisphenol A or diglycidyl ether of Bisphenol F; the aliphatic diepoxide resin comprises one or more alkane diols of glycidyl ether; the cycloalkylamines are N-aminoalkylpiperazines; and the dialkylamines are according to the formula H2N—R—NH2, wherein R is a branched or unbranched C2-C10 alkyl group. The hardenable media, when substantially cured, preferably has a static compression bending value (ASTM F1717) of at least about 60 lbs, and at least about 100 lbs when fully cured. The media is preferably substantially cured in about 90 minutes or less, and the curing takes place at a temperature of about 45° C. or less, more preferably about 43° C. or less.
FIG. 6 is a cross-sectional view through the inflatable fixation device of FIG. 5, in the expanded position .
The deployment system 100 further comprises an implantable inflatable. orthopedic device 102, which may function, in a spinal fusion application, as an inflatable or formed in place fixation plate or rod. Implantable device 102 is removably carried by the distal end of the tubular body 104, such that inflation lumen 130 is in communication with the interior cavity 146 of the inflatable device 102. The inflation media may thus be infused through inflation port 126 (or opening 127) located at manifold 124 to fill the cavity 146.
Although a cylindrical configuration for balloon 114 is illustrated herein, any of a variety. of alternative cross sectional configurations may be utilized. The overall length, diameter and wall thickness of the implantable inflatable orthopedic device 102 may be varied, depending on the particular treatment and access site. In one embodiment, device 102 has an inflated length between about 2 and 12 cm, and often between about 5 cm and about 8 cm for adjacent vertebrae fixation. The device 102 has an inflated diameter of generally between about 0.5 and 2 cm.
A one or a two part epoxy having a viscosity in the range of from about 100 to about 1000 cps is then injected into the balloon under pressure such as by using a pump and pressure within the range of from about 4 ATM to about 10 ATM or more depending upon viscosity, balloon strength and other design considerations. The pump is run for a sufficient duration and under a sufficient pressure to ensure that the epoxy wets all of the fibers. This may range from about 10 minutes or more to about an hour, and, in one application where the pump was run at about 5 ATM pressure, requires at least about ½ hour. Specific method parameters may be optimized depending upon the viscosity of the epoxy, infusion pressure, infusion flow rate, density of the packed carbon fibers, and other variables as will be apparent to those of skill in the art in view of the disclosure herein.
In an alternate embodiment, carbon fibers having within the range of from about 15 to about 45 degrees of braids are utilized. The braid may be in the form of a plain weave, and may be obtained, for example, from Composite Structures Technology (Tehachapi, Calif.). A 0.5 inch diameter of 45 degrees braided carbon fiber sleeve is positioned within the center of the balloon. This braided sleeve conforms dimensionally to the inside diameter of the balloon. A 0.3 inch diameter braided carbon sleeve (again 45°×45° plain weave) may also be positioned concentrically within the balloon, within the outer braided carbon fiber sleeve. Unidirectional fibers are thereafter introduced inside of the ID of the inner braided carbon sleeve. Unidirectional fibers are also introduced into the annular gap between the two braided sleeves. The volume of the fiber per volume of balloon is generally within the range of from about 40% to about 55%. After placement of the foregoing structure within the portals of the screws, the epoxy mix having a viscosity within the range of from about 100 to about 1000 cps is injected under 10 atmospheres pressure into the balloon.
The epoxy or the polyurethane material preferably has a relatively fast cure rate at 37° C. A low viscosity (no greater than from about 100 to about 1000 cps) facilitates rapid transluminal introduction through the delivery catheter and wetting of the relatively small interstitial spaces between adjacent carbon fibers. In addition, the polymer is preferably radiopaque. The polymerization is preferably minimally exothermic, to minimize or prevent thermal damage to the surrounding tissue. One epoxy which may be useful in the present invention is Epotek 301 available from Epoxy Technology, Inc. (Billerica, Mass.). This epoxy reaches 50 to 60% of its strength within about three to four hours following deployment, at 37° C. Using a bonding agent having these approximate characteristics, the patient can be restrained from rolling for an initial cure period of approximately three or four hours to achieve a partial cure (e.g., at least about 50% and preferably 60% or more), and be maintained in bed for a secondary cure period such as approximately the next eight to twelve hours or more to accommodate a full cure. Other formulations of two part epoxies or polyurethanes with faster cure times (preferably no more than about one hour full cure) can be formulated by changing the ratios of components and formulations for the catalysts. Cure time can also be accelerated through the use of accelerators, such as catalysts or the application of heat as is discussed in detail below.
In accordance with certain embodiments, preferred hardenable media have one or more of the following characteristics: (1) they cure completely at a temperature that approximates that of an animal body (about 35-42° C.); (2) they exhibit mildly exothermic curing behavior, meaning that the media only self-heats due to the curing reaction to a temperature below about 45° C., preferably below about 42° C. so as to reduce the risk of heat damage to nearby living tissues during curing; (3) they exhibit little or no shrinkage of during curing so as to maintain a tight fit following curing; (4) they have a pre-cure viscosity of preferably about 100-1000 cps, more preferably about 100-400 cps; (5) they have a useful life (“potlife”) (i.e. have a viscosity low enough to allow for injection) of no more than about 30 minutes after mixing/initiation/activation, preferably no more than about 15 minutes; (6) they are substantially cured (i.e. they are capable of forming a rigid rod of material) preferably within about 20-100 minutes or less, including within about 30, 40, 50, 60, 70, 80, and 90 minutes or less after initiation, such as by mixing; (7) they will form a substantially cured rod having a static compression bending value (per ASTM F1717) of at least about 60 lbs. (force), including about 70, 80, 90 and 100 lbs.; (8) they will form a fully cured rod (unreinforced) having static compression bending values (per ASTM F1717) within the range of from about 100 to about 200 lbs (force), preferably greater than about 150 lbs, including about 110, 120, 130, 140, 160, 170, 180, and 190 lbs., preferably within about 10-12 hours of initiation; (9) they will form a fully cured rod (unreinforced) having a static torsion (per ASTM F1717) within the range of from about 300 to about 500 inch pounds, preferably in excess of about 400 inch pounds; and (10) they will form a biocompatible solid. Especially preferred embodiments of hardenable media exhibit most or all of the foregoing characteristics.
One preferred family of hardenable media are two part epoxies having a very short cure time. The first part preferably comprises one or more compounds bearing epoxide groups, preferably two or more epoxide groups, and has a low viscosity. Preferred compounds include diepoxide resins having molecular weights between about 100 and 400, including, but not limited to, aromatic diepoxide compounds such as diglycidyl ether of Bisphenol A, and diglycidyl ether of Bisphenol F. Other preferred compounds include aliphatic epoxide resins, including cycloaliphatic resins. One preferred class of aliphatic epoxide resins are the diepoxide resins that are alkane diols of glycidyl ether, wherein the alkane portion is pentane, butane, propane, and the like. Such compounds generally have low viscosity (less than about 100 cp) and are sometimes called “reactive diluents” in that, when they blended with other epoxide materials, they serve to reduce the viscosity of the mixture as well as react to form cross-links within the matrix of the cured epoxy. The first part may also comprise monofunctional epoxide modifiers. In a preferred embodiment, the first part comprises a mixture of aromatic diepoxide compounds and aliphatic diepoxide compounds.
The second part preferably comprises one or more curing agents or hardeners, including, but not limited to, aliphatic and cycloaliphatic hardeners, mercaptan curing agents, and amine curing agents such as diamines, triamines, tetramines, methylamines, ethylamines, propylamines, aminopiperazines, and other specialty amines. Preferred curing agents or hardeners allow for cure of the media at ambient or near ambient temperatures, preferably below about 45° C. Preferred compounds include 1,3 diaminopropane, diethylenetriamine, triethylenetetramine, N-aminoethylpiperazine (including N-aminoethylpiperazine nonyl/phenol from Air Products and Chemicals, Allentown, Pa.) and compounds according to the general formula:
H2NR—NHXR—NH2
wherein each R is independently selected from branched or unbranched chains of about 2-10, preferably 2-5, carbon atoms, and x is 0, 1, or 2. In preferred embodiments, R is alkyl, preferably straight chained, and all R groups are the same. In some embodiments, the second part comprises a mixture of a cycloalkylamines, such as piperazine-based amines, and alkylamines.
Formulation Component (weight %)
Part 1 Diglycidyl Ether of Bisphenol A 46.75%
Butane Diol of Glycidyl Ether 20.00%
Part 2 n-aminoethylpiperazine nonyl/phenol 28.34%
1,3 diaminopropane 4.91%
Part 1 Diglycidyl Ether of Bisphenol A 49.12%
Butane Diol of Glycidyl Ether 21.05%
Part 2 n-aminoethylpiperazine nonyl/phenol 21.05%
1,3 diaminopropane 8.78%
Part 1 Diglycidyl Ether of Bisphenol A 51.47%
Butane Diol of Glycidyl Ether 22.06%
Part 2 n-aminoethylpiperazine nonyl/phenol 22.06%
diethylene triamine 4.41%
Part 1 Diglycidyl Ether of Bisphenol A 51.09%
Butane Diol of Glycidyl Ether 21.90%
Part 2 n-aminoethylpiperazine nonyl/phenol 21.90%
triethylene tetraamine 5.11%
Part 1 Diglycidyl Ether of Bisphenol A 49.82%
Butane Diol of Glycidyl Ether 21.35%
Part 2 n-aminoethylpiperazine nonyl/phenol 24.20%
triethylene tetraamine 4.63%
For embodiments using other resins and/or hardeners, the amounts used will need to be adjusted to maintain the stoichionietric ratios (epoxy groups to amino groups), as will be appreciated by those skilled in the art.
Terms such as “hardenable” or “curable” media are used interchangeably herein, and are intended to include any material which can be transluminally introduced through the catheter body into the cavity 146 while in a first, flowable form, and transitionable into a second, hardened or polymerized form. These terms are intended to cover materials regardless of the mechanism of hardening. As will be understood by those of skill in the art, a variety of hardening or polymerizing mechanisms may exist, depending upon media selection, including hardening or polymerization due to exposure to UV or other wavelength of electromagnetic energy, catalyst initiated polymerization, thermally initiated polymerization, and the like. Mechanisms such as solvent volatilization may also be used, but are disfavored due to the greater likelihood of the formation of voids in the cured rod by evaporating solvent. While the media selection may affect catheter design in manners well understood by those of skill in the art, such as to accommodate outgassing of byproducts, application of heat, catalysts, or other initiating or accelerating influences, these variations do not depart from the concept of the invention of introducing a flowable media into a shape and subsequently curing the media to the shape. Two part media, such as a two part epoxy or polyurethane, or a monomer and an initiator may be introduced into the cavity 146 through separate lumen extending throughout the tubular body. Expandable media may also be provided, such as a material which is implantable in a first, reduced volume, and which is subsequently enlargeable to a second, enlarged volume such as by the application of water or heat, or the removal of a restraint.
A study was undertaken demonstrating the low exotherm during polymerization or hardening of a rod according to a preferred embodiment. The study involved the use of two pigs. In the first pig, 8 rods were implanted for mechanical strength studies. In the second pig, 5 rods were implanted for conducting thermal studies. All the rods were implanted in the back muscle near the vertebral structure. Epoxy formulation VL-14 mixed with tungsten powder (1-5 micron size) was injected at a pressure of about 8 atm (about 118 Psi) into the balloon to form the rod 2-3 minutes after it was mixed using an Angioplasty pump. Thermocouples were connected to the outside surface of the rods implanted in the second pig and a multichannel recorder connected to a PC monitored the temperature measured at the surface of the rod from the injection (time 0) to 60 minutes following injection at intervals of one minute. The data for one of the recorded channels is presented in FIG. 53. The data obtained for the other channels was substantially similar to that presented in the figure. As can be seen in FIG. 53, the maximum temperature reached was 40.5° C. The mechanical data obtained after curing period of 90 minutes resulted in an average of 93.5 lbf for maximum bending compression strength for the construct as defined by ASTM F-1717.
In order to accomplish the objective of accelerating polymerization of the epoxy or other hardenable media, the heating element preferably elevates the temperature of the epoxy to a point above normal body temperature. Temperatures at the heating element of at least about 43°, preferably at least about 50°, and, under certain circumstances as high as 60° C. or more are desirable to produce an optimal cure rate. However, the outside of the implant is preferably not heated to the extent that it causes localized tissue necrosis. Tissue necrosis occurs at approximately 45° C. Thus, the heat source preferably sets up a temperature differential between the surface of the implant and the interior of the implant. This may be accomplished in several ways; such as, for example, selecting materials and thickness of the outer flexible wall 148 to provide thermal insulation of the adjacent tissue from heat generated by the heating element. As an alternative or in addition, heat sink structures may be provided at or near the outer surface of the orthopedic device 102. A flow path such as an annular space formed within a double walled balloon may be utilized to circulate a coolant such as saline or other circulating cooling fluid. Such measures preferably permit the heating element to be heated as high as 50° C. or higher, while maintaining the outside surface of the device 102 at a temperature of no more than about 45° C., and, preferably no more than about 43° C.
Alternatively a thermistor 314 may be used to monitor the temperature of the inflatable orthopedic device 102. Thermistors are well known in the art. Using one or more separate thermistors 314 would entail more electrical contacts (not shown) as another electrical loop in addition to the one running the heating element may be necessary. Other methods of measuring the temperature include the use of an optical fiber in conjunction with a thermally reactive material, a coaxial plunger in conjunction with a thermal bulb, or a semiconductor temperature sensor or junction (such as a diode) carried by the orthopedic implant. A bimetallic heating element may fuinction similarly to a circuit breaker and self-regulate.
First, the present method comprises identifying a patient who is a suitable candidate for undergoing the method. In connection with a spinal application, a suitable candidate has one or more unstable vertebrae, one or more portions of one or more vertebrae at least partly separated from the remainder of the vertebrae, one or more portions of one or more vertebrae at least partly separated from the remainder of the vertebrae with potential or complete separation, or has one or more vertebrae or a portion of one or more vertebrae displaced from its normal position relative to the vertebral column, or has one or more portions of one or more vertebrae at least partly separated from the remainder of the vertebrae and displaced from its normal position relative to the vertebral column. Further, the suitable candidate will normally have either pain, loss of function or real or potential instability which is likely due to the separation or displacement, or separation and displacement. If only a portion of the vertebra. is unstable, separated or displaced, the portion of the vertebra that is unstable, separated or displaced will generally include at least part of the vertebral body and adjoining pedicle. However, other unstable, separated or displaced portions of a vertebra can be repositioned or fixed using the present method, as will be understood by those with skill in the art with reference to this disclosure. For example, a suitable patient can have a disease or condition such as spondylosis, spondylolisthesis, vertebral instability, spinal stenosis and degenerated, herniated, or degenerated and herniated intervertebral discs, though actual indications require the expertise of one of skill in the art as will be understood by those with skill in the art with reference to this disclosure.
Then, as shown in FIG. 27, the balloon of the inflatable connection rod 222 is inflated with a rapid setting, curable media such as liquid polymer, or its equivalent, and the polymer is allowed to set fixing each bone screw 208 in relation to each other and repositioning and fixing the vertebra 200 or portion of the vertebra that was unstable, separated or displaced. In one embodiment, the liquid polymer is or includes a two part epoxy or other hardenable media such as those discussed elsewhere herein, and curing is optionally accelerated by the application of heat. The inflated balloon of the inflatable connection rod 222 expands radially beyond the diameter of the portals of each bone screw 208 which helps fix the bone screws 208. in relation to each other.
IG. 41 schematically illustrates the distal end of a deployment system 258 for deploying the crossbar 222 c of FIG. 40. The tubular body 254 is carried by a dilator 260 which extends axially therethrough. In one application, the dilator 260 is approximately 21 French, for accommodating a tubular body 254 having an inside diameter of about 7 mm and an outside diameter of about 8 mm.
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U.S. Classification 606/60, 606/331, 604/920, 602/13, 606/192, 606/907, 606/262
International Classification A61B17/58, A61F2/44, A61B, A61L27/34, A61B17/56, A61L27/00, A61B17/60, A61B17/17, A61B17/16, A61B17/00, A61B17/86, A61B17/70, A61F2/46, A61B17/88
Cooperative Classification A61F2/4611, A61B2017/00557, A61B17/1671, A61B17/7083, A61B17/7001, A61B17/1796, A61B17/60, A61B17/7049, A61B17/7013, A61B17/8863, A61B17/7008, A61B17/7002, A61B17/1757, A61B17/864, A61B17/1697
European Classification A61B17/16S4, A61B17/88F, A61B17/70B1, A61F2/46B7, A61B17/16W, A61B17/60, A61B17/70T4