US20040147957A1 - Helical orthopedic fixation and reduction device, insertion system, and associated methods - Google Patents
Helical orthopedic fixation and reduction device, insertion system, and associated methods Download PDFInfo
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- US20040147957A1 US20040147957A1 US10/737,161 US73716103A US2004147957A1 US 20040147957 A1 US20040147957 A1 US 20040147957A1 US 73716103 A US73716103 A US 73716103A US 2004147957 A1 US2004147957 A1 US 2004147957A1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0469—Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
- A61B17/06066—Needles, e.g. needle tip configurations
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/064—Surgical staples, i.e. penetrating the tissue
- A61B17/0642—Surgical staples, i.e. penetrating the tissue for bones, e.g. for osteosynthesis or connecting tendon to bone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/72—Intramedullary pins, nails or other devices
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
- A61B17/8872—Instruments for putting said fixation devices against or away from the bone
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0482—Needle or suture guides
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/84—Fasteners therefor or fasteners being internal fixation devices
- A61B17/86—Pins or screws or threaded wires; nuts therefor
- A61B17/869—Pins or screws or threaded wires; nuts therefor characterised by an open form, e.g. wire helix
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
- A61B2017/06052—Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
- A61B17/06066—Needles, e.g. needle tip configurations
- A61B2017/06076—Needles, e.g. needle tip configurations helically or spirally coiled
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
- A61B17/06166—Sutures
- A61B2017/06171—Sutures helically or spirally coiled
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/064—Surgical staples, i.e. penetrating the tissue
- A61B2017/0647—Surgical staples, i.e. penetrating the tissue having one single leg, e.g. tacks
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/064—Surgical staples, i.e. penetrating the tissue
- A61B2017/0649—Coils or spirals
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Abstract
An orthopedic system for fixation of a soft tissue tear includes a generally helical fixation element. A hollow, generally helical insertion element is dimensioned to admit at least a distal portion of the fixation element into a lumen thereof. The insertion element is insertable in a screwing motion along the soft tissue tear, and is removable in a reverse screwing motion, leaving the fixation element positioned helically in bridging relation along the tear. A pair of guide needles is provided, wherein one needle is insertable along each of opposed sides of the tear. The proximal ends of each needle are movable into a closely opposed relation, so that when the pair of needles are closely opposed, the insertion element is insertable along the tear in encompassing relation to the pair of needles.
Description
- This application is a divisional of and incorporates by reference co-pending application Ser. No. 09/697,451, filed Oct. 26, 2000, now U.S. Pat. No. 6,663,633, which is commonly owned with the present invention and which is incorporated herein by reference.
- 1. Field of the Invention
- The present invention relates to surgical devices and methods, and, more particularly, to orthopedic devices and methods for fixating soft tissue and reducing fractures.
- 2. Description of Related Art
- Orthopedic procedures are typically undertaken to repair structural injuries or address structural problems. Among these are fracture reduction and the fixation of soft tissue tears.
- Soft tissue tears are often desired to be treated by placing the two sides of the tear into intimate (or tight) apposition to permit healing. This can be achieved, for example, by suturing the tear or by placing an implement into the tissue to breach the tear and bring the sides together.
- A common soft tissue tear, especially in athletes, occurs in the menisci of the knee. Posterior peripheral tears of the menisci may be treated by an open technique, wherein sutures are placed along the tear. An arthroscopic technique may also comprise placing sutures along the tear or inserting a meniscal dart or screw of one of the types known in the art. Screws having heads, however, are known to cause problems within a joint, even if they are resorbable, since a typical resorption time is in the range of 6-9 months. Further, screws and darts are typically substantially rigid elements that can cause discomfort in the patient. There are a number of fastener-type devices known in the art. A surgical fastener is disclosed by Screiber (U.S. Pat. No. 4,873,976) that comprises a shaft having at least one barb for locking the shaft in place when inserted into soft tissue. Bays et al. (U.S. Pat. Nos. 4,884,572 and 4,895,148) describe a surgical-repair tack and applicator and method of using them. The tack has a barb member and is made of biodegradable material having a degradation time selected to coincide with the healing time of the tissue. In an alternate embodiment, the tack's barb comprises a continuous helical barb.
- A method and apparatus for repairing a meniscal tear is disclosed by Winters (U.S. Pat. No. 5,059,206), comprising a fastener having protrusions or barbs that is applied to a meniscal tear with a delivery device. Variable-pitch bioresorbable meniscal screws that are insertable across a tear are also taught by Justin and Winters (U.S. Pat. Nos. 5,569,252 and 5,730,744).
- Another example of an orthopedic injury the treatment of which could be improved is a torn carpal ligament, which will permit the carpal bones to spread apart without securing them together during the healing process. At present this is addressed by connecting the affected bones with smooth pins, necessitating the immobilization of the wrist. These pins must then be removed after healing.
- Yet another example of a fracture is the crushing of the distal aspect of the radial bone, which can leave a posterior defect after the reduction adjacent the bone's head. Such a fracture cannot be treated simply by applying a cast, since, left unattended, the wedgelike defect will permit the radius to deform upward to close the gap.
- Current methods of treating such fractures include affixing plates to the bone, a procedure that is painful and may injure adjacent tendons; injecting paste into the defect zone, which does not consistently effect a correction and which cannot be modified once the paste sets; and inserting pins or external fixation, which can cause stress risers in the adjacent bone that can lead to stress fractures or loss of reduction from not directly supporting the bone defect.
- It is therefore an object of the present invention to provide a device and method for reducing fractures.
- It is a further object to provide such a device that biases the two sides of a wedge-shaped bone defect into a natural position to promote proper healing.
- It is another object to provide such a device that does not impinge upon surrounding soft tissue.
- It is an additional object to provide such a device that is insertable arthroscopically or percutaneously.
- It is yet a further object to provide a device and method for fixating a soft tissue tear.
- It is yet another object to provide such a device that brings two sides of a soft tissue tear into apposition to promote healing.
- An additional object is to provide a device and method for compressing adjacent bones during the healing of a connecting ligament without excessive constraint and maintaining a desired physiological relationship.
- A further object is to provide a device and method for promoting healing of a fixated soft tissue tear.
- Another object is to provide a device and method for creating a vascular access channel.
- These and other objects are achieved by the present invention, an orthopedic reduction and fixation device, insertion system, and associated methods. The system for fixation of a soft tissue tear comprises the device, which in one embodiment comprises a flexible, generally helical fixation element biased to a predetermined pitch. In an alternate embodiment the device comprises a helical portion and a nonhelical portion, the helical portion biased to a predetermined pitch. In yet another embodiment the helix is biased to a first pitch along a distal portion, a second pitch along a central portion, and a third pitch along a proximal portion. The second pitch is smaller than the first and the third pitches, so that, upon insertion across a tear, the central portion will contract, bringing the sides of the tear closer together to promote healing.
- The system also includes a hollow, generally helical insertion element dimensioned to admit at least a distal portion of the fixation element into a lumen thereof. The insertion element in one embodiment has a first pitch along a distal portion, a second pitch along a central portion, and a third pitch along a proximal portion. The second pitch is larger than the first and the third pitches and is also larger than the fixation element predetermined pitch. The insertion element is further insertable in a screwing motion across the soft tissue tear and is positionable with the central portion bridging the tear.
- The fixation element is insertable into the insertion element, and the insertion element is removable in a reverse screwing motion, leaving the fixation element positioned across the tear. The positioning of the central portion permits the fixation element to contract following removal of the insertion element to bring the two bridged sides of the tear together, permitting them to heal.
- Among the many advantages of the helical fixation element is its dynamic nature; unlike a rigid or semirigid screw, a flexible helix can move with the tissue, accommodating stresses laterally and under compression and stretching, while returning to its natural predetermined pitch. Alternatively, in some embodiments the element may have a higher level of stiffness, particularly along the portion of the element bridging the tear, to resist stretching/elongation under physiological conditions. Additionally, since the device is headless, there can be no additional trauma caused by such a protrusion. Further, since a helical structure can be inserted into a hole only as large as the diameter of the coil element, the wound needed for insertion is far smaller than would be required for another type of anchoring element, such as a screw; the resistance to pullout is also much better, an axial force alone not being able to achieve removal. It is also believed that the helical device can effect greater compression than a screw. In addition, even if the coil breaks in the tissue, the complex fixation with the tissue enables a maintenance of structural integrity.
- A further embodiment of the invention comprises suture material as a component of the fixation element. In a first subembodiment suture material resides within an insertion element lumen for insertion. Upon withdrawal of the insertion element the suture material remains, along a substantially helical pathway, essentially “stitching” the tear together. In a second subembodiment the fixation element comprises a nonresorbable suture material core surrounded by a resorbable, shape-retaining material formed into a substantially helical shape along at least a portion thereof adapted for placement across the tear. In use, then, when the fixation element is placed across the tear, the resorbable material preferably remains in place for a time commensurate with a healing time; following resorption, the suture material remains, providing permanently added stability.
- Another embodiment of the invention comprises an orthopedic system for stabilizing two sections of a bone in spaced-apart relation, such as is desired in crushing-type injury to a wrist. The system includes an insertion guide that comprises an elongated guide element having a length sufficient to span a bone requiring fixation. The guide element also has a diameter that is dimensioned for insertion through a bore in the bone or through a fracture defect. The insertion guide also comprises means for preventing a distal end of the guide element from entering the bone bore. The preventing means may comprise a deployable element that is movable between an insertion orientation and an anchoring orientation wherein the guide element from entering the bone bore.
- The system further includes a coil element that is dimensioned for insertion into a fracture or defect and has a bore dimensioned for threading over the guide element. The coil element is biased in an outward direction for fixating two sections of bone in a desired spaced-apart orientation.
- The features that characterize the invention, both as to organization and method of operation, together with further objects and advantages thereof, will be better understood from the following description used in conjunction with the accompanying drawing. It is to be expressly understood that the drawing is for the purpose of illustration and description and is not intended as a definition of the limits of the invention. These and other objects attained, and advantages offered, by the present invention will become more fully apparent as the description that now follows is read in conjunction with the accompanying drawing.
- FIGS.1A-1C is an exploded view of a first embodiment of the orthopedic fixation system with the device entering soft tissue having a tear (FIG. 1A); being positioned across a soft tissue tear inside the insertion device (FIG. 1B); and in place with the insertion device removed (FIG. 1C).
- FIG. 1D is a perspective view of the embodiment of FIG. 1A being used to fixate a double tear in soft tissue.
- FIG. 1E is a perspective view of a plurality of devices of FIG. 1A being used to fixate a soft tissue tear.
- FIG. 1F is a perspective view of a helical device as in FIG. 1A having been positioned along a curved soft tissue tear with a curved insertion device.
- FIG. 1G is a side view of a wedge-shaped helical device in position in a meniscus.
- FIG. 1H is a perspective view of the device being introduced into soft tissue over a needle without an insertion element.
- FIG. 1I is a side view of a combined device and introducer.
- FIG. 1J is a cutaway view of another spiral device and introducer embodiment.
- FIG. 1K illustrates the use of a hybrid coil/suture device used in meniscal repair.
- FIG. 1L is an exploded view of a helical device and insertion element, with the insertion element having a variable pitch.
- FIG. 1M is a perspective view of a fixation element having a bioresorbable overlayer and a flexible core.
- FIG. 1N illustrates a flexible core having surface barbs left in place across a tear.
- FIG. 1O illustrates a flexible core having surface beads.
- FIGS.1P-1R illustrate a system and method for fixating a tear using wires for closing the tear (FIGS. 1P, side cross section, and 1Q, top plan view) and a helical fixation element for fixating the tear (FIG. 1R).
- FIG. 2A is a perspective view of the system of FIG. 1A with a limiting element in place.
- FIG. 2B is a side perspective view of an alternate embodiment of the fixation system of FIG. 1A for use in repairing soft tissue tears.
- FIG. 2C is a top plan view of the embodiment of FIG. 2B in place in soft tissue in repairing a tear therein.
- FIG. 2D is a side view of a hybrid coil and suture fixation device.
- FIG. 2E is a side view of a helical fixation device with a limiting length of suture and suture loop.
- FIG. 3 is an exploded view of a second embodiment of the orthopedic fixation system with a tissue dilator in an insertion position.
- FIG. 4 illustrates the embodiment of FIG. 3 with the dilator in an expanded position.
- FIG. 5 is a side perspective view of a third embodiment of the orthopedic fixation device being deployed to reduce a distal radial fracture.
- FIGS. 6A and 6B are side perspective views of a fourth embodiment in an insertion position (FIG. 6A) and being deployed for fixating a tibial fracture (FIG. 6B).
- FIG. 6C is a side perspective view of a tibial fracture being stabilized with a pair of arms and a helical element.
- FIG. 7 is a side perspective view of a fourth embodiment of the orthopedic fixation device for use in opposing articular bone surfaces.
- FIGS. 8A and 8B are side cross-sectional views of a fifth embodiment of the fixation device adapted for creating a vascular access channel in the insertion position (FIG. 8A) and in the expanded position (FIG. 8B).
- FIG. 9 is a side cross-sectional view of a sixth embodiment of the fixation device adapted to differentially create a vascular access channel as well as fixate a soft tissue tear.
- FIG. 10 illustrates the use of a spiral device as a suture anchor.
- A description of the preferred embodiments of the present invention will now be presented with reference to FIGS.1A-10.
- Several embodiments of the present invention will be presented. As indicated above, it is desirable to provide a reducing and fixation system for addressing a plurality of orthopedic problems.
- Systems for Fixation of a Soft Tissue Tear
- A first embodiment of the present system is an
orthopedic system 10 for fixation of asoft tissue 90 tear 91 (FIG. 1A), here shown as a meniscal tear, although this is not intended as a limitation. Thesystem 10 comprises a flexible, generallyhelical fixation element 12 that is biased to a predetermined pitch, preferably a plurality of pitches along a length thereof. Thehelical element 12 has acentral lumen 14 extending between adistal end 15 and aproximal end 16. In a preferred embodiment acentral portion 17 of thehelix 12 has a higher spring constant than theend portions helix 12 has afirst pitch 131 along theproximal end portion 18, asecond pitch 132 along thecentral portion 17, and athird pitch 133 along thedistal end portion 19, wherein thesecond pitch 132 is smaller than the first 131 and the third 133 pitches. Thehelix 12 may also be bioresorbable and comprise a material known in the art having a resorption constant commensurate with a healing time of thesoft tissue tear 91 to be repaired. - The
system 10 further comprises a hollow, generallyhelical insertion element 20 that has a centralaxial lumen 29 and ahelical lumen 21 dimensioned to admit at least a distal portion of thehelix 12 thereinto. Theinsertion element 20 has a substantiallyconstant pitch 22 along a length thereof. - In an alternate embodiment (FIG. 1L) the
fixation element 12′″ has a substantiallyconstant pitch 13 therealong, but theinsertion element 20′ has a variable pitch. Here theinsertion element 20′ has afirst pitch 221 along aproximal portion 27, asecond pitch 222 along acentral portion 26, and athird pitch 223 along adistal portion 24, with thesecond pitch 222 greater than the first 221 and the third 223. This configuration similarly causes thehelix 12′″ to contract the tear sides together when in place thereacross. - In another embodiment (FIG. 1M) the
fixation element 126 comprises asuture material 30 core surrounded by a resorbable, substantially shape-retaininghelical overlayer 127. In use this embodiment is positioned as those described above, but following insertion theresorbable overlayer 127 bioresorbs over time, preferably over a time commensurate with the healing time of the tear, leaving thesuture core 30 in place essentially permanently, to continue to provide support in the region of the tear but without the presence of a rigid member. This embodiment is envisioned as useful, for example, with partially healed meniscal tears under the surface, with thesuture 30 having less chance of forming a cyst as with previously known devices. - In two related embodiments the
fixation element 126′,126″ comprisingsuture material 30′,30″has directional barbs 128 (FIG. 1N) or beads 129 (FIG. 1O), respectively. Thebarbs 128 are preferably pointed toward a central region so that they are pointing toward the tear when in place thereacross. These surfaceprotrusions overlayer 127 bioresorbs, and achieve improved purchase into the tissue. - The embodiment of FIG. 1N additionally has a plurality of
fenestrations 120 therein. Thesefenestrations 120 provide a porous surface into which fibrous tissue may invaginate, again achieving an improved purchase to and retention within the tissue. - The
insertion element 20 is insertable in a screwing motion across thesoft tissue tear 91 and is positionable with the central portion 25 bridging the tear 91 (FIG. 1B). Thefixation element 12 is insertable into the insertion element'slumen 21, and theinsertion element 20 is removable in a reverse screwing motion, permitting thefixation element 12 to be left in position across the tear 91 (FIG. 1C). Once theinsertion element 20 is removed, at least thecentral portion 17 of thehelix 12 contracts to its natural,predetermined pitch 13 to bring two sides of thetear 91 together with compression. This apposition of the tear's sides will permit healing to occur. - In a preferred embodiment the
system 10 further comprises means for limiting thehelix 12 to a predetermined maximum length but does not limit compression to a smaller length. Such a limiting means may comprise, for example, a flexible limiting element, such as a piece ofsuture 30, having afirst end 31 positioned in restraining relation to thedistal end 15 of thehelix 12. This may be accomplished, in a particular embodiment, by the suture'sfirst end 31 comprising a “T”-shaped element having acrosspiece 32 flexibly attached to thesuture 30. Thecrosspiece 32 is then insertable through the helix'slumen 14 and braceable against the helix'sdistal end 15, not unlike the attachment pieces used to affix clothing tags. - Means are also positioned at a
second end 33 for preventing the helix'sproximal end 16 from passing therebeyond. Again this means may comprise a “T”-shaped element at thesecond end 33, acrosspiece 34 thereof positionable across the helix's proximal end 16 (FIG. 2A). - This embodiment of a limiting element is not intended to represent a limitation on the invention, as one of skill in the art will recognize numerous possible variations thereto. For example, a “bead” at one end can also be used to retain that end in a desired position. Alternatively (FIG. 2E), a
loop 301 of flexible material such assuture 30 may be affixed to one end of thehelix 12 that can be affixed following or during fixation of thetear 91 to the other end to provide additional stability and length limiting of thehelix 12. - In another embodiment of this system for repairing
soft tissue 90tears 91, ahelical insertion element 20 as described above is loaded with a piece of highly flexible material, for example, but not limited to, suture 30 (FIG. 2B). This flexible material for this embodiment is preferably not biased to a particular orientation. Thesuture 30 is passed through thelumen 21, with afirst end 301 emerging from the insertion element'sproximal end 202. Asecond end 302 of thesuture 30 emerges from the insertion element'sdistal end 204, and then is passed through theaxial lumen 29, so that thesecond end 302 and thefirst end 301 are both accessible proximal of theinsertion device 20. Preferably thedistal end 204 of theinsertion element 20 is pointed for penetrating thesoft tissue 90. - In use, the loaded
insertion element 20 is inserted in spiral fashion to “stitch” two opposing sides of thetear 91 together (FIG. 2C). Then theinsertion element 20 is removed from thesoft tissue 90, leaving thesuture 30 in place. Finally, thesuture 30 is tightened by pulling theends tear 91 with closely opposed sides that can more readily heal than those repaired with other methods known in the art. Thesuture 30 may be of the resorbable or nonresorbable type depending upon the type and site of the tear. - Another hybrid type of
system 50 comprises afixation element 51 that includes a helicalcentral portion 511. Thishelical portion 511 should have sufficient stiffness to fixate asoft tissue tear 91″. Theelement 51 further includes two elongatedflexible elements helical portion 511. A preferred embodiment of thesystem 50 further includes a narrowelongated element 52. - In use, the
elongated element 52, typically having a pointedtip 521, is inserted across atear 91″, shown in FIG. 2D as aruptured tendon 90′. In this case the tendon ends are aligned axially first. Thehelical portion 511 is then screwingly inserted over theelongated element 52 in bridging relation to thetear 91″, and theelongated element 52 is removed. Next theflexible elements tissue 90′ and secured, such as by knotting. A particular advantage of this system is that frayed ends of thetendon 90′ may be captured and held by thehelical portion 511, while leaving a substantial amount of the tissue exposed and available for fluid contact. - The system of the present invention in a preferred embodiment also comprises a
guide needle 40. Theneedle 40 has a diameter that is smaller than theaxial bore 29 of theinsertion element 20 and is insertable across thetear 91. Theneedle 40 is also sufficiently long to enter thetissue 90 and bridge the tear 91 (FIG. 1A). - The
insertion element 20 is insertable across thetear 91 in encompassing relation to theneedle 40. In certain embodiments theguide needle 40 may be shaped to optimize access to thetear 91. For example, in repairing a knee meniscus, theneedle 40 would preferably be curved in order to permit access around adjacent bone structure. - The
system 10 further comprises acannula 42 adapted to pierce askin 92 of a patient and into thesoft tissue 90 proximal of the tear 91 (FIG. 1A). Thecannula 42 is adapted to admit theinsertion element 20 therethrough for positioning across thetear 91. - In a particular embodiment the system50 (FIGS. 3 and 4) may also comprise means for dilating a
hole 93 in thesoft tissue 90. Thedilator 51, a generally cylindrical element, is movable between an insertion position having afirst diameter 52 that is adapted to slide within thecannula 42 and over theguide needle 40 and a dilating position having asecond diameter 53 that is larger than thefirst diameter 52. The dilating position is for maintaining ahole 93 that facilitates the healing of thetear 91, by permitting the invasion of reparative tissue. Thesecond diameter 53 should be sufficiently small to admit theinsertion element 20 thereover. Alternatively, means may be provided for inserting afibrin clot 94 into thehole 93 for further facilitating healing of thetear 91. - The method of fixating a
soft tissue tear 91 with thesystem 10 as described above comprises the steps of inserting acannula 42 through theskin 93 into the soft tissue 90 (FIG. 1A). Then aguide needle 40 is inserted across thetear 91 and theinsertion element 20, over theneedle 40 across thetear 91 in a screwing motion. Next at least a distal portion of thehelix 12 is inserted into the insertion element'slumen 21, which may be accomplished from either direction. Finally, theinsertion element 20 is withdrawn in an unscrewing motion (FIG. 1B), leaving thehelix 12 in position across the tear 91 (FIG. 1C). Thecentral portion 17 of thehelix 12, upon withdrawal of theinsertion element 20, contracts to itspredetermined pitch 13, which draws two sides of thetear 91 together and permits thetear 91 to knit. - It may also be seen that the
device 12 may be used to repairdouble tears soft tissue 90 by advancing onedevice 12 across bothtears - Further, a plurality of
helical devices 12 may be used to repair a unitary tear 91 (FIG. 1E). For example, afirst device 12 could be positioned along thetear 91 in one location and asecond device 12′, across thetear 91 in another location. - In yet another embodiment of the
system 10′, ahelical fixation element 12 is positioned along the axis of atear 91 with aninsertion element 20′ shaped to conform with the shape of thetear 91. In the so-called “bucket handle”tear 91 of ameniscus 90 shown in FIG. 1F, which typically will not heal easily, theinsertion element 20′ has an arcuate curvature adapted to proceed along thetear 91, Upon its removal, thehelix 12 remains in place, bridging the tear with multiple points of fixation. Preferably theinsertion element 20′ has apitch 200 greater than apitch 120 to which thehelix 12 is biased, so that thehelical lumen 121 decreases upon removal of theinsertion element 20′. The repair of thistear 91 permits the adjacent condyle to become a compressive rather than disruptive load. - In yet another embodiment of the
system 10″ (FIG. 1G) thehelical fixation element 12″ is generally wedge-shaped for fixation of atear 91 in a wedge-shaped portion of tissue, such as, but not limited to, ameniscus 90. That is, thehelix 12″ has afirst diameter 122 at aproximal end 123 that is larger than that 124 at adistal end 125. Likewise, the insertion element (not shown) would have a first diameter at a proximal end that is larger than that at a distal end. - In use, the
helix 12″ is inserted into the insertion element, which is screwed either across or along atear 91. Next the insertion element is removed, leaving thehelix 12″ in place. A particular advantage of the helical shape in this embodiment lies in the fact that a larger-diameter device can be introduced into the tissue without causing the damage that would ensue if a screw of the same diameter were to be inserted. - In addition, it can be appreciated by one of skill in the art that the embodiments of the present invention, such as those illustrated in FIGS. 1F and 1G, are easily accommodated to particular situations, and a variety of shapes of helical and insertion elements could easily be provided to optimize the desired repair.
- Another
system 10′″ for fixating asoft tissue tear 91 comprises aneedle 40 that has a pointed distal tip 41 (FIG. 1H). In use, theneedle 40 is inserted into thetissue 90 in bridging relation to thetear 91, and thehelix 12 is inserted into thesoft tissue 90 in a screwing motion with thelumen 14 of thehelix 12 in surrounding relation to theneedle 40. Once thehelix 12 is positioned as desired, the needle is withdrawn, leaving thehelix 12 in bridging relation to thetear 91. Thissystem 10′″ is contemplated for use without an insertion element, such as directly through the patient's skin into the tear site. For this embodiment thehelix 12 has sufficient structural integrity on its own to permit such an insertion, and may comprise a stiffer material such as a metal. - The
helix 12 in this embodiment can be presized to a desired situation; alternatively, thehelix 12 could be frangible or cuttable to a desired length either before or after insertion. - In yet another embodiment a pair of
wires tear 91 that extends through to a surface of atissue 90, wherein thetear 91 will typically spread apart into a “V”-shaped cross section (FIG. 1P). Thewires wires surfaces - Next the
helix 12 is advanced down the coupledwires wires helix 12 in place stabilizing the tear 91 (FIG. 1R). - In a related system the
helix 12 is frangibly attached at aproximal end 123 to thedistal end 431 of aninsertion device 43, a generally linear elongated wire having ahandle 44 at the proximal end 432 (FIG. 1I). In use, thehandle 44 facilitates the screwing motion to insert thehelix 12. Once a tear is bridged, theinsertion device 43 is broken away, leaving thehelix 12 in place at the desired site. - In FIG. 1J is illustrated another embodiment of a
fixation system 10 a, wherein thehelical fixation element 12 a is movable between a first orientation having afirst pitch 121 a and a second orientation having asecond pitch 122. Thehelical element 12 a is biased to thefirst pitch 121 a, and has a plurality of laterally extendingprotrusions 123 a affixed thereto. Theprotrusions 123 a are axially alignable in the second orientation. - A generally
cylindrical insertion element 20 a is dimensioned to admit at least a distal portion of thefixation element 12 a into alumen 21 a thereof. Theinsertion element 20 a has agroove 22 a that extends longitudinally within thelumen 21 a that is adapted to admit theprotrusions 123 a thereinto in longitudinal alignment. This serves to retain thehelical element 12 a in the second orientation. - Another system and method for fixating a soft tissue tear includes a
fixation element 12 b that comprises a first 121 b and a second 122 b helical fixation section (FIG. 1K). A section of substantially constant-length material, such assuture material 123 b, is affixed to an end of each of thehelical fixation sections helical fixation section 121 b is inserted into a piece ofsoft tissue 90 on a first side of atear 91 therein. Next the secondhelical fixation section 122 b is inserted into the piece ofsoft tissue 90 on a second side of thetear 91 sufficiently far that the material 123 b is substantially taut across thetear 91. The material 123 b may or may not be flexible depending upon the situation. - Systems for Reduction of a Bond Fracture
- This embodiment of the invention is an
orthopedic system 60 for stabilizing twosections bone 96 in spaced-apart relation. Thesystem 60 comprises an insertion guide that comprises anelongated guide element 61, which has a length that is sufficient to span thebone 96 requiring fixation and a diameter that is dimensioned for insertion through abore 97 in thebone 96. - The
system 60 further comprises acoil element 70 that is dimensioned for insertion into afracture 98 and having anaxial lumen 71 dimensioned for threading over theguide element 61. Thecoil element 70 is biased in an outward direction for fixating twosections bone 96 in a desired spaced-apart orientation. Preferably thecoil element 70 has a pointeddistal end 72 adapted for insertion through the patient'sskin 99. Thecoil element 70, as above, may if desired comprise a bioresorbable material. - It is also preferred that the
guide 61 further comprise means for retaining thecoil element 70 to a desired maximum length. Such a retaining means may comprise, for example, the guide'sproximal portion 62 being bendable from a substantially linear insertion position to a retainingposition 62′ generally perpendicular to the coil element'slumen 71. - The
insertion guide 61 also comprises means for preventing adistal end 65 of theguide element 62 from entering the bone bore 97. In a particular embodiment the preventing means comprises apin 65 that is rotatably affixed to theguide 61 and is movable between an insertion position substantially parallel to theguide 61 and a deployed position substantially normal to theguide 61 for bracing against thebone 96 surface. - A particular embodiment is contemplated for a situation in which the
fracture region 98 is smaller in a distal portion than in a proximal portion. For this instance, thecoil element 70 comprises a generally wedge-shaped helical spring. In this embodiment the user selects a wedge size appropriate for achieving sufficient engagement with the cortex. Depending upon the shape of the fracture region, thecoil element 70 could be cylindrical or ovoid in order to optimally fit the internal contour of the distal radius for cortical contact. - In a particular embodiment it is also advisable to inject a bone-forming (osteoinductive) material into the
coil element 70 in place in thefracture region 98 to stimulate healing. - In another embodiment, a
device 66 for stabilizing two sections of fracturedbone 96, such as a tibia, eliminates the need for an external fixator as is currently known in the art, which is believed to reduce complications during healing such as infections and irritation. Thisdevice 66 comprises a pair ofarms stop 68 that is dimensioned to prevent its movement into abore 97 at the smaller end of thefracture 98. Astop 68 is hingedly connected at afirst end 681 along a central portion of afirst arm 661 for movement between an insertion position (FIG. 6A) with thesecond end 682 adjacent thefirst arm 661 wherein thearms arms second end 682 of thestop 68 bracing thesecond arm 662 and substantially perpendicular to botharms - Means are provided for moving the
stop 68 to the deployed position. A first moving means comprises a flexible member such assuture 683 affixed adjacent the stop'ssecond end 682 that can be pulled by the user to move thestop 68 to the deployed position (FIG. 6A). A second moving means comprises aspring 684 affixed to thefirst arm 661 in biasing relation to thestop 68 for biasing thestop 68 to the deployed position (FIG. 6B). - In order to improve the fixation, a
plate 981 may be affixed to the bone surface adjacent the wider end of thefracture 98. - For additional support, a pair of
devices 66 may be positioned within thefracture 98 in generally perpendicular relation to each other. - In an alternate,
related embodiment 66′ ahelical element 70 is insertable into the fracture between thearms 661,662 (FIG. 6C) to stabilize the fixation. In a preferred embodiment “skids,” or groove means, 701 are provided along the inner surfaces of thearms helix 70 into the gap. - System for Stabilizing Opposing Articular Bone Surfaces
- This embodiment of a system60 (FIG. 7) is for use in situations in which it is desired to retain a pair of
bones carpal bones - The
system 60 of the present invention for addressing this situation comprises adevice 61 having a first 611 and a second 612 end portion and a central helical portion 613 having a spring constant adapted to retain thebones bone tunnels - In a particular embodiment of this
system 60, a generallycoaxial bore bone 62 and intobone 63. Thefirst end portion 611 of thedevice 61, here shown as helical, is positioned within thebore 622, and thesecond end portion 612, also helical, within thebore 632. Means are provided for retaining theend portions respective bores screws bores end portions bones - It may also be contemplated by one of skill in the art that additional embodiments could be envisaged, such as, but not limited to, end portions comprising press-fittable plugs.
- System for Creating a Vascular Access Channel
- The present invention also includes a
system 80 for creating avascular access channel 89 insoft tissue 90 adjacent atear 91 to promote healing. Thesystem 80 comprises aguide needle 40 that is adapted for insertion intosoft tissue 90 adjacent atear 91 therein. Acannula 42 is adapted for insertion into thesoft tissue 90 in surrounding relation to theguide needle 40. - A generally
helical element 81 has a diameter that is adjustable between aninsertion diameter 82, which is dimensioned for insertion within thelumen 421 of thecannula 42 and in surrounding relation to the guide needle 40 (FIG. 8A) and an expandeddiameter 82′ greater than the insertion diameter 82 (FIG. 8B). Thehelical element 81 is biased to the expandeddiameter 82′. - In a preferred embodiment the
helical element 81 also has a plurality of generally outwardly-extendingbarbs 811 that are adapted to engagesoft tissue 90 and enhance the channel-creating aspect of the device. - The benefit of such a
system 80 is in improved healing, since thechannel 89 created in thesoft tissue 90 permits reparative tissue to invade, such as blood vessels and blood components. In addition, thechannel 89 permits the insertion of a fibrin clot, also to enhance healing. In the meniscus of the knee, for example, only the outer 2-3 mm is vascularized, whereas the inner portion is less vascularized, making healing difficult. Present devices not only do not help in this process; they actively prevent reparative tissue entry, since they are typically solid devices. Thehelical element 81 of the present invention, however, creates achannel 89 while enabling access into the lumen thereof not only from the proximal end, but also from the sides. - The flexibility and adaptability of the device may also be seen in a dual use, wherein another embodiment of the
helix 84 has differential spring constants along different portions thereof for different purposes. As shown in FIG. 9, afirst portion 841 is biased to an expanded diameter for creating achannel 89 in thesoft tissue 90, and asecond portion 842 is biased to contract across thesoft tissue tear 91 to contract the sides of the tear into apposition for healing. - System for Affixing a Flexible Element to a Bone
- A system and method for fixating an element to a
bone 96 are also provided within the scope of the present invention. A device 55 is provided that comprises ahelical fixation element 12c that is insertable within abone 96, either through asmall hole 961 therein, or having a pointeddistal end 551 and sufficient stiffness to pierce the bone surface itself to form the hole 961 (FIG. 10). Thedistal end 551 is continued to be inserted until thecortex 962 is passed through and thecancellous area 963 is reached. The device 55 further comprises means for affixing aflexible element 56 thereto at aproximal end 552. - Among the possible embodiments of this system and method are included a fixation of suture or a piece of soft tissue to the
bone 96. As with the soft tissue embodiments above, the spiral nature of the fixation element creates a resistance to pullout while also providing excellent fixation characteristics. A much smaller hole is required to insert the helix than would be required for a screw of the same diameter, which means that less damage is being done to the bone structure. - It may be appreciated by one skilled in the art that additional embodiments may be contemplated, including alternately shaped coil elements and insertion elements for different applications.
- In the foregoing description, certain terms have been used for brevity, clarity, and understanding, but no unnecessary limitations are to be implied therefrom beyond the requirements of the prior art, because such words are used fordescription purposes herein and are intended to be broadly construed. Moreover, the embodiments of the apparatus illustrated and described herein are by way of example, and the scope of the invention is not limited to the exact details of construction.
- Having now described the invention, the construction, the operation and use of preferred embodiment thereof, and the advantageous new and useful results obtained thereby, the new and useful constructions, and reasonable mechanical equivalents thereof obvious to those skilled in the art, are set forth in the appended claims.
Claims (27)
1. An orthopedic system for fixation of a soft tissue tear comprising:
a generally helical fixation element; and
a hollow, generally helical insertion element dimensioned to admit at least a distal portion of the fixation element into a lumen thereof, the insertion element insertable in a screwing motion along the soft tissue tear, the insertion element removable in a reverse screwing motion, leaving the fixation element positioned helically in bridging relation along the tear.
2. The system recited in claim 1 , further comprising means for limiting the fixation element to a predetermined maximum length without limiting compression to a smaller length.
3. The system recited in claim 2 , wherein the limiting means comprises a flexible limiting element having a first end positioned in restraining relation to a distal end of the fixation element and having means at a second end for preventing a proximal end of the fixation element from passing therebeyond.
4. The system recited in claim 1 , further comprising a pair of guide needles, one needle insertable along each of opposed sides of the tear, proximal ends of each needle movable into a closely opposed relation, wherein, when the pair of needles are closely opposed, the insertion element is insertable along the tear in encompassing relation to the pair of needles.
5. The system recited in claim 1 , wherein the fixation element has a first pitch and the insertion element has a second pitch greater than a pitch of the first pitch.
6. The system recited in claim 1 , wherein the fixation element comprises a bioresorbable material.
7. The system recited in claim 1 , further comprising a flexible restraining element having a first end affixed to a first end of the fixation element and a second end affixable to a second end of the fixation element, the first ends of the restraining element and the fixation element opposed to the second ends of the restraining element and the fixation element, respectively, for retaining the flexible element to a desired maximum length.
8. The system recited in claim 1 , wherein the insertion element has an arcuate curvature for repairing an arcuate tear in a generally wedge-shaped portion of soft tissue.
9. The system recited in claim 8 , wherein the fixation element has a first pitch and the insertion element has a second pitch greater than a pitch of the first pitch.
10. An orthopedic system for fixation of a soft tissue tear comprising:
a flexible fixation element; and
a hollow, generally helical insertion element dimensioned to admit at least a distal portion of the fixation element into a lumen thereof, the insertion element insertable in a screwing motion along the soft tissue tear, the insertion element removable in a reverse screwing motion, leaving the fixation element positioned helically in bridging relation along the tear.
11. The system recited in claim 10 , wherein the fixation element comprises suture material.
12. The system recited in claim 10 , wherein the fixation element comprises a bioresorbable material.
13. A method of fixating a soft tissue tear comprising the steps of:
inserting a generally helical insertion element along a soft tissue tear in a screwing motion;
inserting at least a distal portion of a generally helical, flexible fixation element into a lumen of the insertion element; and
withdrawing the insertion element in an unscrewing motion, leaving the fixation element in position along the tear, drawing two sides of the tear together.
14. The method recited in claim 13 , further comprising the step of limiting a length of the fixation element to a predetermined maximum length.
15. The method recited in claim 14 , wherein the limiting step comprises affixing a first end of a flexible limiting element in restraining relation to a distal end of the fixation element, a second end of the flexible limiting element affixed to a proximal end of the fixation element.
16. The method recited in claim 13 , further comprising the steps, prior to the insertion element inserting step, of inserting a pair of guide needles along each of opposed sides of the tear
moving proximal ends of each needle into a closely opposed relation; and
wherein the insertion element inserting step comprises inserting the insertion element along the tear in encompassing relation to the pair of needles.
17. The method recited in claim 13 , wherein the fixation element has a first pitch and the insertion element has a second pitch greater than a pitch of the first pitch.
18. An orthopedic system for fixation of a soft tissue tear comprising:
a length of flexible material having a first end and a second end; and
a hollow, generally helical insertion element comprising a plurality of loops and dimensioned to admit the flexible material into a helical lumen thereof, a portion of the flexible material extending from a distal end thereof and passable through the lumen toward a proximal end of the insertion element, the insertion element insertable in a screwing motion along the soft tissue tear, at least some of the loops of the insertion element bridging the tear, and the insertion element removable from the soft tissue in a reverse screwing motion, leaving the flexible material positioned in stitching relation to the tear, the first and the second ends of the flexible material tightenable to bring two sides of the tear together.
19. The system recited in claim 18 , further comprising means for limiting the fixation element to a predetermined maximum length without limiting compression to a smaller length.
20. The system recited in claim 19 , wherein the limiting means comprises a flexible limiting element having a first end positioned in restraining relation to a distal end of the fixation element and having means at a second end for preventing a proximal end of the fixation element from passing therebeyond.
21. The system recited in claim 18 , further comprising a pair of guide needles, one needle insertable along each of opposed sides of the tear, proximal ends of each needle movable into a closely opposed relation, wherein, when the pair of needles are closely opposed, the insertion element is insertable along the tear in encompassing relation to the pair of needles.
22. The system recited in claim 18 , wherein the fixation element has a first pitch and the insertion element has a second pitch greater than a pitch of the first pitch.
23. The system recited in claim 18 , wherein the fixation element comprises a bioresorbable material.
24. The system recited in claim 18 , further comprising a flexible restraining element having a first end affixed to a first end of the fixation element and a second end affixable to a second end of the fixation element, the first ends of the restraining element and the fixation element opposed to the second ends of the restraining element and the fixation element, respectively, for retaining the flexible element to a desired maximum length.
25. The system recited in claim 18 , wherein the insertion element has an arcuate curvature for repairing an arcuate tear in a generally wedge-shaped portion of soft tissue.
26. The system recited in claim 25 , wherein the fixation element has a first pitch and the insertion element has a second pitch greater than a pitch of the first pitch.
27. A method for repairing a tear in soft tissue comprising the steps of:
inserting a generally helical insertion element along a soft tissue tear in a screwing motion, the insertion element having a helical lumen and a first portion of flexible material inserted therethrough, a second portion of flexible material extending out of a distal end of the insertion element and passing through an axial lumen thereof;
removing the insertion element while leaving the flexible material in place in stitching relation to the soft tissue tear;
pulling ends of the flexible material sufficiently taut to bring two sides of the tear together; and
securing the flexible material ends to retain a desired level of tautness in the soft tissue.
Priority Applications (1)
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US20220117598A1 (en) * | 2015-05-26 | 2022-04-21 | Lmt, Llc | Systems and methods for fixing soft tissue |
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US10028733B2 (en) | 2015-05-28 | 2018-07-24 | National University Of Ireland, Galway | Fistula treatment device |
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WO2018022903A1 (en) * | 2016-07-27 | 2018-02-01 | Kenneth Binmoeller | Helical tissue anchor device and delivery system |
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US11452512B2 (en) | 2017-06-09 | 2022-09-27 | Signum Surgical Limited | Implant for closing an opening in tissue |
EP3996611A4 (en) * | 2019-07-10 | 2023-11-01 | Aesclepius Corporation | Systems, devices, and methods for bone suture attachment and support |
WO2022047653A1 (en) * | 2020-09-02 | 2022-03-10 | 南微医学科技股份有限公司 | Handle mechanism, delivery system, and operating method |
Also Published As
Publication number | Publication date |
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WO2002034139A2 (en) | 2002-05-02 |
US6663633B1 (en) | 2003-12-16 |
AU2002227185A1 (en) | 2002-05-06 |
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