WO1999049792A1 - Bioabsorbable surgical fastener for tissue treatment - Google Patents
Bioabsorbable surgical fastener for tissue treatment Download PDFInfo
- Publication number
- WO1999049792A1 WO1999049792A1 PCT/EP1999/002231 EP9902231W WO9949792A1 WO 1999049792 A1 WO1999049792 A1 WO 1999049792A1 EP 9902231 W EP9902231 W EP 9902231W WO 9949792 A1 WO9949792 A1 WO 9949792A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- fastener
- meniscus
- proximal
- tissue
- distal
- Prior art date
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Classifications
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00004—(bio)absorbable, (bio)resorbable, resorptive
-
- 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
Definitions
- the present invention relates to a surgical fastener or device (implant) formed in the shape of an arrow comprising a shaft with a proximal (first) portion having a blunt end and tapered form, such that the proximal portion is broad at its blunt end and tapers in the direction of a distal (second) portion of the shaft, the distal portion having protrusions and a pointed end, wherein the tapered form of the proximal portion and the protrusions of the distal portion are configured to lock the implant in a position inside a soft and/or tough tissue according to the use of the implant.
- the implant may be manufactured of a polymer or a polymeric compound which is substantially (bio)absorbable (resorbable) after implantation in tissue and contains an oriented reinforcing structure or the like of a polymer or polymeric compound or ceramic bioactive glass compound.
- the surgical implant of the invention is particularly, but not solely, suitable for use in surgically repairing traumas of soft and/or tough tissues containing fibrous structures, such as knee meniscal tissues.
- the channel used to install the implant must have the cross-sectional shape of the stem; thus, it is difficult to guide the implant in the installation channel, because the guiding effect is substantially brought upon the stem only, but not the body of the arrow due to its shape.
- the structure of the stem causes tissue irritation and abrasion, particularly when placed in connection with the meniscus because the stem is usually left protruding to a high degree from the outer surface of the meniscus.
- Bays et al. (U.S. Pat. Nos. 4,884,572 and 4,895,141, the entire disclosures of which are incorporated herein by way of this reference) describe a surgical-repair tack and applicator and method of using them.
- the tack has a barb member, a shaft portion and a grip portion.
- the tack is made of biodegradable material having a degradation time selected to coincide with the healing time of the tissue.
- the tack's barb comprises a continuous helical barb.
- a disadvantage of this tack is that the grip portion is bulky and may remain on the meniscal surface, causing irritation inside a joint cavity.
- the method and apparatus for repairing a meniscal tear disclosed by Winters comprises a fastener having protrusions or barbs that is applied to a meniscal tear with a delivery device.
- the delivery device has a flexible tip that is manipulable through a curved radius to enable the surgeon to insert the device into the central part of the knee and then extend the fastener radially outward into and across a meniscal tear.
- the proximal end of the fastener is bulky comprising a cylindrical end (head member) which protrudes partially above and/or below the outer surface of the meniscus.
- Tamminmaki et al. disclose an arrow-like bioabsorbable implant particularly intended for the surgical repair of meniscal ruptures.
- This implant does not have the guiding or abrasion problems that the implants of U.S. Pat. No 4,873,976 or U.S. Pat. No. 5,059,206 may have.
- a disadvantage of the device of U.S. Pat. No. 5,562,704 is that the proximal part of the implant (the wings) preferably remains on the surface of the meniscus, so that when the wings break as a consequence of bioabsorption, the broken wings may irritate knee joint tissues.
- the proximal part with the wings is desired to be located inside of meniscal tissue, the surface capsule of the meniscus must be cut horizontally with a special cutting blade. This lengthens the operation time and causes substantial damage to the meniscus surface.
- U.S. Pat. No. 5,569,252 the entire disclosure of which is incorporated herein by way of this reference, describes a fastener, an installation device, and method for repairing tears in the soft tissue of a patient, including meniscal tears.
- the fastener has a variable-pitch helical protrusion along a central portion that decreases from the distal end to the proximal end, which can serve to bring two sides of the tear into opposition as the fastener is advanced across the two sides of the tear in a screwing motion.
- This implant which needs a screwing motion for installation, is slow and tedious to use arthroscopically and the turning of the implant through fibrous tissue, such as meniscus tissue, has the risk that the fibrous tissue may twist around the turning implant, hindering or preventing the installation of the implant.
- a fastener for body tissue repair comprising: a shaft comprised of a proximal portion, having an upper surface and a lower surface with first protrusions, and a distal portion, said distal portion having a sharpened tip and one or more first protrusions, wherein said first protrusions have proximal surfaces configured to arrest the movement of the shaft in the proximal direction and distal surfaces configured to permit the movement of the shaft in the distal direction, said proximal portion having second protrusions on the upper surface and lower surface of the proximal portion, wherein said second protrusions have distal surfaces configured to arrest the movement of the shaft in the distal direction.
- the second protrusions can be damaged, e.g., bent or broken, during the insertion of the implant into tissue, or the second protrusions can damage the tissue, e.g., by cutting the horizontal collagen fibers of the tissue during the insertion.
- bioabsorbable fastener that allows a minimally invasive method for repairing a tear in soft or tough tissue. It is a further object of the invention to provide such a fastener that is rapid and easy to install and gives a strong and safe fixation of the tissue tear and that may be made from a nontoxic, biocompatible bioabsorbable polymer, polymer alloy or fiber reinforced polymer composite, specially designed to maintain its structural integrity during the healing of the tear and to prevent tissue abrasion. It is an additional object to provide such a fastener having a
- the fastener of the present invention is designed for repairing a tear in soft and/or tough tissue of a patient, such as a tear of the meniscus within the knee.
- the surgical fastener or device (implant) of the present invention has been formed in the shape of an arrow comprising a shaft with a proximal (first) portion having a blunt end and tapered form so that the blunt end of the proximal portion is broad and it tapers in the direction of a distal (second) portion of the shaft, the distal portion having protrusions and a pointed end, the tapered form of the proximal portion and the protrusions of the distal portion configured to lock the implant in a position inside a soft and/or tough tissue according to use of the implant.
- protrusions emerge from the distal portion of the device.
- the protrusions are typically barbs, scales, threads, serrations, ridges or the like. These protrusions at the distal portion of the shaft of the device prevent the installed device from slipping out of the meniscal tissue in the direction opposite to the direction of installation. At least one or more of the protrusions must penetrate the rupture plane inside of the tissue, to lock the distal portion of the device into the tissue at a position distal of the tear.
- the tapered form of the proximal portion of the shaft allows the penetration of the shaft into the meniscal tissue when the fastener is pushed, shot or hammered into the tissue.
- the penetration of the proximal portion of the shaft into the meniscal tissue causes minimal damage, because the penetrating, tapered proximal portion does not cut the horizontal collagen fibers of meniscal tissue, but separates them from each other when the proximal portion forms a cavity for itself in the meniscal tissue.
- the opening of such a cavity inside of meniscal tissue for the tapered proximal portion requires a substantial amount of external pushing force from the installation device, which pushes the fastener into the meniscal tissue.
- the fastener stops inside of the meniscal tissue and the tapered proximal portion prevents the further penetration of the fastener into the meniscal tissue. In this way, the combined effect of the distal protrusions and the proximal tapered portion lock the fastener effectively inside of the meniscus, to close and fix the meniscal rupture to enhance its healing.
- the protrusions of the distal portion of the shaft of the device are formed so that they facilitate the slipping of the device into the meniscus during insertion, while resisting the slipping of the device in the direction opposite to the installation direction.
- the tapered proximal portion of the shaft of the device is formed so that it stops the device inside of the meniscal tissue when the device has been pushed or shot into the meniscus with the delivery (installation) tool.
- the surface of the shaft may include longitudinal ridges.
- the ridges promote healing of the rupture by providing channels along the interiors of the ridges through which beneficial blood flow can occur along the
- These channels which are typically about 0.05-0.5 mm wide, act as capillaries, transporting blood from the highly vascularized distal portion (outer periphery) of the meniscus to the poorly vascularized proximal portion (inner periphery) of the meniscus. Further, the ridges help to guide the fastener through the cannula of the installation instrument and into the meniscal or other soft tissue during installation.
- FIGS. 1 A- IE illustrate, seen from above, fasteners (devices) in accordance with the invention.
- FIG. 2 illustrates a ridged fastener in accordance with the invention.
- FIGS. 3A-3G illustrate, seen from the proximal end of the fastener, different proximal end profiles of fasteners in accordance with the invention.
- FIGS. 4-7 describe different ridge profiles of fasteners in accordance with the invention.
- FIGS. 8A-D illustrate a cross-section of the installation of the fastener of the invention into a torn meniscus.
- FIGS. 9-10 illustrate the fibrous structure of the meniscus for repair.
- FIG . 11 illustrate the orientation of the fibrous structure of the meniscus in relation to an installed fastener of the invention.
- the preferred exemplary embodiment of the present invention comprises a fastener
- FIGS. 1A-1E illustrate, as viewed from above, some preferred embodiments of the fastener. It is designed to have an arrow shape, and it comprises a shaft 1 , whose proximal portion 2 is formed with a blunt end 2a for the purpose of providing the impact surface required for the instrument used in its installation (delivery tool), and whose distal portion 3 is formed with a head with a sharp tip 3a.
- the distal portion comprises distal protrusions 4 with respect to the shaft 1.
- the distal protrusions depicted in FIGS. 1 A- IE are small, sharp-profile barbs.
- proximal portion 2 The purpose of the proximal portion 2 is to stop the implant inside of the meniscus, typically just below the surface of the meniscus during the final stage of the installation. To achieve this task, the proximal portion 2 is formed tapered with maximum width near the blunt end 2a, so that the tapered end stops the device and prevents its further sinking into the meniscus, when the pushing effect of the delivery tool stops.
- the tapering effect of the device can be varied and can extend to different distances from the proximal end of the fastener along the shaft 1.
- the tapering reaches to the tip 5a of the wedge-like fastener.
- the tapered proximal portion 2 may have different cross-sectional geometries. Some preferred embodiments are described in FIG.2, where, seen from the proximal end of the fastener, different proximal end profiles are described.
- the proximal portion is flat. Such a flat proximal portion penetrates into meniscal tissue causing only a minimal disturbance to the internal structure of the meniscus.
- the flat and broad proximal portion stops the fastener effectively inside of the meniscal tissue.
- the flat proximal portion can have a thicker midsection, advantageously even thicker than the diameter d of shaft 1.
- the thickening of th tapered proximal portion increases its locking effect inside of meniscal tissue.
- FIGS. 2C and 2D show proximal portions with a triangular and a quadrangular cross-section, respectively.
- FIG. 2E shows a proximal portion with a cross-like cross-section. This kind of proximal portion is also seen in FIG.
- FIG. 2F shows the circular cross-section of a (conical) proximal portion.
- FIG. 2G describes the cross- sectional geometry of a proximal portion comprising three tapering ridges.
- the proximal tapered portion 2 and distal protrusions 4 effectively lock the device inside of the meniscus preventing, after insertion, its movement both in the direction of installation and in the direction opposite to it. Additionally, the installation of the device serves to advantageously compress the rupture surface (see FIGS. 8A-D) because the proximal tapered portion 2 pushes the proximal side of the rupture against the distal side of the rupture during the final phase of installation.
- the surface of the fastener can also include longitudinal ridges, into which the arresting means (proximal tapered portion and distal protrusions) can be machined or molded.
- FIG. 3 A shows a side-view perspective of such a fastener having on its surface four longitudinal ridges 13, which are arranged onto the surface of the fastener according to FIG. 3B, which shows the cross-section of the fastener in the plane A-A of FIG. 3 A.
- distal protrusions e.g., barbs
- the distal protrusions can be machined effectively into the longitudinal ridges. It is evident that other types of distal protrusions, than those described in FIG. 1 and 3, can be used in the fasteners of the invention. Such protrusions are described, e.g., in United States Patent Application Serial No. 08/887,130, the entire disclosure of which is incorporated herein by way of this reference.
- FIGS. 4-7 illustrate some preferred embodiments of the cross-sectional structures of ridged fasteners.
- FIGS. 8A-D illustrate a preferred method for installing fasteners of the invention into ruptured meniscal tissue.
- Figure 8A illustrates, as viewed from the side, a meniscus with a rupture, 6, separating the meniscus into a proximal side, 7a, and a distal side, 7b.
- FIG. 8B illustrates, during the operation, the tip 8b of a cannula 8 is pushed into the knee joint through a small incision and the tip is located on the surface of the proximal part of the meniscus 7a (in relation to the rupture 6).
- the piston 9 moves to the left (distally) and pushes the fastener 10 through the hole 8a inside of the cannula 8.
- the piston 9 can be accelerated to a high speed so that the piston 9 pushes (shoots) the fastener 10 with a high speed into the meniscus as is illustrated in FIG. 8D.
- the piston 9 stops at the final stage of its movement (by way of, e.g., a stopper (not shown) at the proximal end of the piston 9), typically so that the tip of the piston 9 protrudes out of the tip 8b of the cannula 8 about 0.5-1 mm, thus pushing the fastener totally inside of the meniscal tissue.
- a stopper not shown
- the piston 9 pushes and forces the fastener 10 totally inside of the meniscal tissue.
- the tapered proximal portion 11 of the fastener is forced inside of the meniscal tissue (see FIG. 8D) , it imparts the pushing force into the proximal part of the meniscus 7a, thereby closing the rupture 6.
- the piston 9 stops typically 0.5-1 mm below the surface of the meniscus
- the proximal tapered portion 1 1 stops the fastener and prevents its further movement into the meniscal tissue.
- the distal portion of the device 12 is pushed across the rupture 6 and into the distal side of the meniscus 7b, where the distal protrusions 12a prevent the slipping of the fastener back in the direction opposite to the installation direction. Accordingly, the rupture 6 is closed effectively, the fastener is locked into its position to keep the rupture 6 closed, and the whole fastener has been buried with minimal damage inside of the meniscal tissue, thus eliminating the risks related to prior art implants that have parts located on the surface of the meniscus. It is typical that the microstructure of a meniscus contains reinforcing collagen fibers.
- the horizontal collagen fibers are seen as parallel, horizontal fiber bundles, as is shown schematically in FIG. 10. Because of the special arrangement of the main portion of reinforcing horizontal collagen fibers inside of the meniscus, shown schematically in FIGS. 9 and 10, it is important that the distal protrusions are located at least on the upper and lower surfaces of the distal portion of the fastener, so that as the fastener penetrates into the meniscal tissue, the distal protrusions slide forward through the collagen fiber bundles and ultimately grip between the horizontal collagen fiber bundles, locking the fastener in place.
- proximal portion is tapered and broadened in the direction of its proximal end so that it locks the proximal portion into place inside of the meniscus, when the pushing effect of the installation device is ended.
- This arrangement of an installed fastener of the invention is shown schematically in FIG. 11 as a meniscal cross- section.
- a typical meniscus also includes oriented fibers that are not horizontal.
- the meniscus can also contain fibers having radial or oblique orientations.
- the collagen fibers form an essentially three-dimensional network in the meniscus, with such fibers being of particular importance with regard to using the present invention for treating the typical vertical (bucket handle) tears that occur.
- some of the fibers will have other orientations (e.g., vertical), such that when the device of the invention enters the resultant three-dimensional network of collage fibers it will not slip out or through that network.
- bioabsorbable implants of this invention can be manufactured of bioabsorbable polymers, copolymers or polymer mixtures or alloys with melt molding methods known in the prior art. It is also possible to use the techniques of U.S. Pat. No. 4,743,257, the entire disclosure of which is incorporated herein by reference, to mold (in a compression or
- the implants of this invention can be molded in a single compression molding cycle, or the protrusions can be machined on the surface of a fastener after the molding cycle.
- the oriented and/or self-reinforced structure of the material used to make the invention can also be created during extrusion or injection molding of an absorbable polymeric melt, through a suitable die or into a suitable mold at high speed and pressure. When cooling occurs at suitable conditions, the flow orientation of the melt remains at least partially intact in the solid material as an oriented or self-reinforcing structure.
- Such suitable conditions include rapid cooling to a temperature well below the melting point of the polymeric material, to lock the desired orientation into the material used to make the invention.
- the mold can have the form of the implant, but it is also possible to manufacture the implants of the invention by machining (optionally, using heat) injection-molding or extruding semi-finished products. It is advantageous to make the implants of melt-molded, solid state drawn or compressed, bioabsorbable polymeric materials, which are described e.g. in United States Patent Nos. 4,968,317 or 4,898,186, the entire disclosures of both of which are incorporated herein by way of this reference.
- the reinforcing fibers of the implant can also be ceramic fibers, like bioabsorbable hydroxyapatite or bioactive glass fibers.
- ceramic fibers like bioabsorbable hydroxyapatite or bioactive glass fibers.
- bioabsorbable, ceramic fiber reinforced materials are described e.g. in European Patent Application No. 0146398 and in WO 96/21628, the entire disclosures of which are incorporated herein by way of this reference.
- the oriented and/or self-reinforced or otherwise fiber reinforced implants of this invention can be manufactured by molding the reinforcement fiber-polymer matrix to the
- the orientation and/or reinforcing elements of the self-reinforced structure are mainly oriented in the direction of the long axis of the shaft of the implant.
- the reinforcement elements may extend into any protrusions or ridges of the implant.
- the reinforcements elements can also turn spirally around the long axis of the implant.
- orientation and/or fiber- reinforcement or self-reinforcement of the implants of this invention is that many of the reinforcing elements are oriented in such a way that they can carry the different external loads (such as tensile, bending and shear loads) that are directed to the healing rupture (for example loads to a meniscus caused by the movements of the patient's knee).
- the meniscal repair implant may contain one or more bioactive substances, such as antibiotics, chemotherapeutic substances, angiogenic growth factors, substances accelerating the healing of the wound, growth hormones and the like.
- bioactive meniscal repair implants are especially advantageous in surgical use, because they chemically contribute to the healing of the lesion in addition to providing mechanical support.
- the oriented and/or reinforced materials of the implants typically have tensile strengths of around 100-2000 MPa, bending strengths of around 100-600 MPa and shear strengths of around 80-400 MPa. Additionally, they are usually stiff and tough.
- the implants of the present invention may be sterilized by any of the well known sterilization techniques, depending on the type of material used in manufacture of the implant. Suitable sterilization techniques include heat or steam sterilization, radiation sterilization, such as cobalt 60 irradiation or electron beams), ethylene oxide sterilization, and the like.
Abstract
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Priority Applications (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AU38120/99A AU3812099A (en) | 1998-04-01 | 1999-03-31 | Bioabsorbable surgical fastener for tissue treatment |
CA002326125A CA2326125A1 (en) | 1998-04-01 | 1999-03-31 | Bioabsorbable surgical fastener for tissue treatment |
EP99920583A EP1067873A1 (en) | 1998-04-01 | 1999-03-31 | Bioabsorbable surgical fastener for tissue treatment |
JP2000540764A JP2002509753A (en) | 1998-04-01 | 1999-03-31 | Biologically absorbable surgical fasteners for treating tissue |
AU2003231636A AU2003231636B2 (en) | 1998-04-01 | 2003-08-06 | Bioabsorbable Surgical Fastener for Tissue Treatment |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US5367098A | 1998-04-01 | 1998-04-01 | |
US09/053,670 | 1998-04-01 |
Publications (1)
Publication Number | Publication Date |
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WO1999049792A1 true WO1999049792A1 (en) | 1999-10-07 |
Family
ID=21985787
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/EP1999/002231 WO1999049792A1 (en) | 1998-04-01 | 1999-03-31 | Bioabsorbable surgical fastener for tissue treatment |
Country Status (6)
Country | Link |
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US (1) | US6551343B1 (en) |
EP (1) | EP1067873A1 (en) |
JP (1) | JP2002509753A (en) |
AU (1) | AU3812099A (en) |
CA (1) | CA2326125A1 (en) |
WO (1) | WO1999049792A1 (en) |
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Also Published As
Publication number | Publication date |
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EP1067873A1 (en) | 2001-01-17 |
JP2002509753A (en) | 2002-04-02 |
CA2326125A1 (en) | 1999-10-07 |
US6551343B1 (en) | 2003-04-22 |
AU3812099A (en) | 1999-10-18 |
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