Patent Application
20100305576
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1. Field of the Invention
The present invention relates generally to surgical devices for forming holes in bone, and for deploying and installing anchoring devices into said holes. More particularly, the invention relates to suture anchor installation tools. Still more particularly, the invention relates to devices including retention means for organizing and holding the free ends of at least one suture or the like extending from an anchoring device, and such needle-like elements as may be attached thereto.
2. Description of Related Art
Suture anchors for positioning an end or intermediate portion of a length of suture within a preformed hole in bone, as well as suture anchor installation tools for deploying such suture anchors, are known in the art. Some of these tools include a handle adapted to hold portions of free suture ends extending from the suture anchor, and any needles that may be attached to such free ends.
The principal purpose of each of the foregoing devices is to provide attachment means for positioning—and for substantially fixedly attaching—a portion of a length of suture to a piece of bone. For a variety of reasons, other attachment means—including nails, screws, and staples—are not satisfactory because: 1) they may cause undesirable damage during installation; 2) they may loosen or fail when subjected to normal post-operative stresses; and 3) they are not adapted to reliably and fixedly hold a length of suture. Thus, suture anchors designed to permanently and fixedly locate a portion of at least one length of suture within a preformed hole in bone have been developed.
Suture anchors generally possess receiving means (including, but not limited to an eyelet, slots, or recesses) for at least one length of suture, whereby the suture may be held by the suture anchor. The relatively confined space in which suture anchors are deployed, and the difficulties associated with threading a length of suture through a suture anchor after it has been inserted into a bone, make post-insertion threading of suture undesirable and impractical. Thus, suture anchors are generally threaded with at least one length of suture prior to their being inserted into a bone. Consequently, the free suture ends extending from the suture anchor must be managed so that they do not become tangled during insertion of the suture anchor.
Along with the development of suture anchors came the development of drivers for installing the suture anchors. Generally, suture anchor drivers provide means for attaching to and engaging with the anchor (e.g., a socket, pins, or other such features on the distal end of the driver, mated to corresponding features on the proximal end of the anchor), conveying the anchor to a desired location, and driving the anchor into the bone. To control or manage the free ends of suture threaded through and extending from the anchor, which otherwise would become tangled and/or obscure the operative field, various methods have been devised to releasably hold the free ends.
While the prior art discloses, generally, pre-threaded suture anchors and suture anchor drivers, those devices necessitate either: 1) a self-tapping suture anchor, wherein the suture anchor itself is designed to cut the insertion hole into the bone as the anchor is inserted; or 2) a separate, dedicated device for producing a hole in a bone, suitable for receiving the suture anchor (e.g., a threaded bone tap—a tool for forming an internal screw thread in bone).
Self-tapping suture anchors may be undesirable because they are resisted by the bone chips formed as they are driven into the bone, and because they cannot be made with polymeric materials. As a self-tapping suture anchor is driven into a bone, the driving force required to advance the anchor increases as bone chips accumulate and resist advancement of the anchor. The user must either back the self-tapping suture anchor out from the hole and clean out the chips formed, or risk: 1) jamming the anchor in an undesirable location (e.g., at an inappropriate depth); 2) fracturing the anchor from applying excessive force; or 3) stripping the newly-cut threads on the inner surface of the hole. A self-threading anchor must also be sufficiently sturdy to withstand the forces required to produce a threaded hole, thus foreclosing the possibility of using certain materials (e.g., biodegradable materials, certain plastics, etc.) to make self-tapping anchors. Finally, the axial and torsional forces required to create a hole in a bone are substantial. Because the suture anchor and driver are removably engaged over a comparatively small surface area, force sufficient to create a hole in a bone using a self-tapping suture anchor may also cause inadvertent disengagement of the suture anchor from the driver. This creates a hazard to medical personnel and patients alike.
A separate, dedicated bone tap is similarly undesirable because it must be separately sterilized, it is comparatively large (comprising at least a handle, shaft, and tap), it occupies valuable space amongst all the other surgical instruments needed during surgical procedures, and it involves unnecessary duplication of components (e.g., a separate handle for the tap). A separate, dedicated bone tap is also undesirable because the user must ensure that the hole diameter and thread profile produced by the chosen tap will be compatible with the suture anchor (e.g., thread diameter, pitch diameter). Otherwise, a substantial risk exists that the diameter and/or threads of the hole produced by the tap may not be suitable for use with the anchor.
In view of the foregoing, the primary object of the present invention is to provide a unitary suture anchor installation device, comprising suture and needle retention means releasably attachable to the device, along with tap means releasably attachable to the device and separate from the suture anchor itself.
Another object of the present invention is to provide a suture anchor installation device wherein: a) a tap for creating a threaded bone hole—an internal screw thread in bone—is releasably engaged; b) the tap is operated to create a threaded hole in a bone—a bone hole—then reversed; c) upon disengagement of the tap from the device, an anchor, at least one length of suture, and a shaft are exposed, the anchor being threaded by the at least one length of suture and also engaged by the shaft for transport to the bone hole; d) the anchor is inserted into the bone hole via a handle operating in association with the at least one length of suture and the shaft; and e) the handle comprises doors releasably engaged with the handle and which further comprise means for attaching free ends of the at least one length of suture and any objects attached thereto.
In one embodiment, an apparatus for inserting surgical implants is provided, comprising: a handle; a shaft extending along a longitudinal axis between first and second ends, wherein the shaft second end engages the handle; an anchor extending along a longitudinal axis between proximal and distal ends, wherein the anchor proximal end engages the shaft first end; and a tap sleeve extending along a longitudinal axis between proximal and distal ends, the tap sleeve having a blind bore with an opening at said tap sleeve proximal end and extending longitudinally toward said tap sleeve distal end, and the tap sleeve distal end comprising a tap; wherein the tap sleeve removably accommodates said anchor and at least a portion of the shaft first end via the tap sleeve blind bore.
In one aspect of this embodiment, the shaft further comprises at least one post. Preferably, the at least one post is cylindrical and projects perpendicular to the shaft longitudinal axis. More preferably, the shaft comprises first and second posts—which may or may not be cylindrical—projecting perpendicular to the shaft longitudinal axis and positioned about 180° from one another about the shaft longitudinal axis. In this aspect, the tap sleeve further comprises at least one notch, wherein the at least one notch is keyed to engage the at least one post. Preferably, the tap sleeve comprises first and second notches keyed to engage the first and second posts.
In another aspect of this embodiment, the apparatus further comprises at least one suture having first and second ends, the anchor further comprises threads, an eyelet, and at least one channel, and the shaft first end comprises at least one installation prong. Preferably, the at least one suture is threaded through the eyelet, and the at least one channel and the at least one installation prong are keyed to engage one another. More preferably, the anchor comprises first and second channels, and the shaft first end comprises first and second installation prongs, wherein the first and second channels and the first and second installation prongs are keyed to engage one another.
In another aspect of this embodiment, the handle comprises at least one cavity and at least one door, wherein the at least one door comprises attachment means for the at least one suture. In a preferred aspect, the attachment means for the at least one suture comprise a plurality of cleats arranged to engage the at least one suture. Preferably, the plurality of cleats are located on the at least one door inner surface. Also preferably, the at least one door is releasably engaged with the handle. More preferably, the handle comprises first and second cavities and first and second doors, wherein the first suture end is engaged with the plurality of cleats of the first door, and the second suture end is engaged with the plurality of cleats of the second door.
In yet another aspect of this embodiment, the first suture end further comprises a first needle attached thereto, and the second suture end further comprises a second needle attached thereto. and the first and second needles are located in the first and second cavities of the handle, respectively.
In another aspect of this embodiment, the shaft further comprises at least one furrow extending substantially from said shaft first end and toward shaft second end, whereby said at least one suture is directed toward the handle, and the handle further comprises at least one suture slot, whereby said at least one suture communicates with said at least one cavity. Preferably, the shaft comprises first and second furrows extending substantially from said shaft first end and toward shaft second end, whereby the first and second suture ends are directed along and within said first and second furrows, respectively, toward the handle, and the handle comprises first and second suture slots, whereby the first suture end communicates with the first cavity and the second suture end communicates with the second cavity.
In yet another aspect of this embodiment, the shaft second end is removably engaged with said handle, the said shaft first end may removably engage with said handle and said shaft second end further comprises at least one removal prong keyed to engage said at least one channel.
In a preferred aspect, an apparatus for inserting surgical implants is provided, comprising: a handle, comprising first and second cavities and first and second doors releasably engaged with the handle, each door comprising a plurality of cleats on the door inner surface, said handle further comprising first and second suture slots; a shaft extending along a longitudinal axis between first and second ends, wherein the shaft second end removably engages the handle and wherein the shaft first end may removably engage with the handle, wherein the shaft comprises first and second posts extending substantially perpendicular to the shaft longitudinal axis, wherein the shaft first end comprises first and second installation prongs, the shaft second end comprises first and second removal prongs, the shaft further comprises first and second furrows extending substantially from said shaft first end and toward shaft second end; an anchor extending along a longitudinal axis between proximal and distal ends, comprising threads, an eyelet, and first and second channels, wherein the anchor proximal end engages the shaft first end, and the first and second channels and first and second installation prong are keyed to engage one another; at least one suture having first and second ends, wherein the at least one suture passes through the eyelet, the first suture end further comprises a first needle and is engaged with the plurality of cleats of the first door, the second suture end further comprises a second needle and is engaged with the plurality of cleats of the second door, whereby the first and second needles are located in the first and second cavities, respectively; and a tap sleeve extending along a longitudinal axis between proximal and distal ends, the tap sleeve having a blind bore with an opening at said tap sleeve proximal end and extending longitudinally toward said tap sleeve distal end, the tap sleeve distal end comprising a tap, the tap sleeve proximal end comprising first and second notches keyed to engage first and second posts; whereby the first and second suture ends are directed along and within said first and second furrows, respectively, toward the handle, whereby the first suture end communicates with the first cavity and the second suture end communicates with the second cavity, wherein the tap sleeve removably accommodates said anchor, said at least one suture, and at least a portion of the shaft first end via the tap sleeve blind bore.
In a second embodiment, a method for attaching soft tissue to bone is provided, comprising the steps of providing an apparatus comprising: a handle, comprising first and second cavities and first and second doors releasably engaged with the handle, each door comprising a plurality of cleats on the door inner surface, said handle further comprising first and second suture slots; a shaft extending along a longitudinal axis between first and second ends, the shaft second end removably engaged with the handle; an anchor extending along a longitudinal axis between proximal and distal ends and comprising an eyelet, wherein the anchor proximal end engages the shaft first end; at least one suture having first and second ends, the suture being threaded through the eyelet, the first suture end comprising a first needle and the second suture end comprising a second needle, wherein the first suture end is engaged with the plurality of cleats of the first door and the second suture end is engaged with the plurality of cleats of the second door; and a tap sleeve extending along a longitudinal axis between proximal and distal ends, wherein the distal end comprises a tap, the tap sleeve further comprising a blind bore extending along the longitudinal axis, the tap sleeve removably attached to the shaft first end and accommodating the anchor, at least a portion of the at least one suture, and at least a portion of the shaft first end; forming a threaded hole in a bony structure with the tap of the tap sleeve removably attached to the shaft first end; removing the tap sleeve from the shaft first end; inserting the anchor into the threaded hole; and attaching soft tissue to said suture.
These and other objects of the invention are achieved by the provision and use of a novel suture anchoring device. In the preferred embodiment, the device is adapted to create a threaded hole in a bone and to deploy a suture anchor into the hole.
For a further understanding of the nature, objects, and advantages of the present invention, reference should be had to the following detailed description, read in conjunction with the following drawings, wherein like reference numerals denote like elements.
Before the subject invention is further described, it is to be understood that the invention is not limited to the particular embodiments of the invention described below, as variations of the particular embodiments may be made and still fall within the scope of the appended claims. It is also to be understood that the terminology employed is for the purpose of describing particular embodiments, and is not intended to be limiting. Instead, the scope of the present invention will be established by the appended claims.
In this specification and the appended claims, the singular forms “a,” “an,” and “the” include plural reference unless the context clearly dictates otherwise. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood to one of ordinary skill in the art to which this invention belongs. Referring now to the drawings, where like elements are designated by like reference numerals,
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Also as shown in
The handle, handle doors, and all other components of the handle (for example, but not limited to, anti-rotation sleeve element (77), cleats (68), etc.) may be made of materials including, but not limited to, acrylonitrile butadiene styrene (“ABS”), polyphenylsulphone (“PPSF” or Radel®), or Ultem®.
The handle (70) is adapted for releasable engagement with both the first end (40A) and the second end (40B), as desired, of shaft (40), as shown in
The second end (40B) of the shaft (40) fits within the central void (86) of the handle (70), as shown in
Instrument (10) also comprises shaft (40), illustrated in greater detail in
As shown in
In a preferred embodiment, both the shaft first end (40A) and the shaft second end (40B) are adapted to fit within the central void (86) of the handle (70), as selected by the user. With this design, the shaft first end (40A) can include installation prongs (41B) and the shaft second end (40B) can include removal prongs (49B) opposite the installation prongs (41B). As desired by the user, either end (40A, 40B) of the shaft (40) can be engaged securely with the handle (70) via anti-rotation sleeve element (77) and triangular bore (87).
As shown in
The shaft (40) may be made of materials including, but not limited to, stainless steel, titanium, and titanium alloy.
As seen in
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The suture anchor (30) may be made of materials including, but not limited to, titanium alloy (e.g., Ti6Al4V), and plastics (e.g., PLLA, PLDLA, PLA/PGA, PEEK, and PLLA/TCP blends). As used herein, “PLLA” is poly-
The shaft first end (40A) and the shaft second end (40B), as well as the suture anchor, suture, and needles, are all provided in a variety of sizes to accommodate the various sizes required for various surgical procedures. The at least one suture (50) can be made of materials including, but not limited to, polyethylene, ultra high molecular weight polyethylene (“UHMWPE,” also known as “high-modulus polyethylene,” “high performance polyethylene,” and “ultra high molecular weight polyethylene”) and woven UHMWPE.
A suture anchor can be conveniently installed into a bone and threaded with a suture or a section of tendon or other soft tissue after installation according to the following method. First, a suture anchor of the appropriate size is selected. A corresponding shaft bearing an appropriate shaft first end (40A) and an appropriate shaft second end (40B) are then selected. An anti-rotation sleeve element is disposed around the shaft and secured with a pin. A handle which is suitable for engaging the shaft first end (40A) and the shaft second end (40B) is then selected. The handle is assembled to the driver shaft by sliding the handle over the shaft and aligning the anti-rotation sleeve on the shaft with the corresponding opening in the handle, with the shaft first end (40A) of the shaft (40) exposed and the shaft second end (40B), with removal prongs (49B), if provided, disposed within the interior of the handle.
The suture anchor (30) may then be loaded onto the shaft (40) of the instrument (10) as follows. The free ends of at least one working or repair suture (50A) is threaded through the eyelet (34) disposed at the drive head (37) of suture anchor proximal end (31). Preferably, the free ends of two separate working or repair sutures (50A, 50B) are threaded through the eyelet (34), and the remainder of this description will describe the use of two sutures. The channels (35) of the anchor (30) are then aligned with the installation prongs (41B) and the recesses (38) are aligned with the shaft furrows (45). The first free suture ends are then guided along a shaft furrow (45) and through a suture slot (79) of sleeve element (77), toward a cavity (81) of the handle (70). The second free suture ends are guided along the opposite shaft furrow (45) and through the opposite suture slot (79) of sleeve element (77), toward the opposite cavity (81) of the handle (70). The first free suture end of a first suture (50A) is threaded about all cleats (68) in a “figure eight” pattern, on one side of the rib (67) of one door (60), and the first free suture end of the second suture (50B) is threaded about all cleats (68) in a “figure eight” pattern, on the opposite side of the rib (67) of the same door (60) used for the first free end of the first suture (50A). Similarly, the second free suture end of the first suture (50A) is threaded about all cleats (68) in a “figure eight” pattern, on one side of the rib (67) of the opposite door (60), and the second free suture end of the second suture (50B) is threaded about all cleats (68) in a “figure eight” pattern, on the opposite side of the same rib (67), of the same door (60) used for the second free suture end of the first suture (50A). If the sutures (50A, 50B) comprise needles (53), they may be mounted within the appropriate niches (69). Then, upon inserting the tongue (64) of a door (60) into an appropriate groove (83) of a handle cavity (81), each door may be pivoted about its tongue (64) to bring the corresponding latch (66) against the corresponding strike (84) and thereby fasten each door closed so that it is substantially flush with the handle (70). Tension on the sutures (50A, 50B) is maintained via a silicone sleeve (not shown) positioned inside of the handle (70), behind the sleeve element (77), and is concentric about and attached to the shaft (40). The sutures (50A, 50B) proceed from the anchor (30), up the furrows (45) in the shaft (40), through the suture slots (79) of the sleeve element (77), and under the silicone sleeve (not shown). Sutures passed between the shaft (40) and the concentric silicone sleeve (not shown) then enter the handle cavity (81) and are attached to the doors (60) via cleats (68). Finally, the shaft (40) bearing anchor (30) secured to it via suture (50A, 50B) is removably inserted into the blind bore (23) of tap sleeve (20) so that the shaft posts (40) interlock with the tap sleeve notches (28).
In this configuration, the instrument may be sterilized via suitable techniques known in the art (for example, without limitation, via autoclaving, gamma irradiation, and ethylene oxide).
In use, the distal tip of the tap (24) may be placed against the bone into which it is to be installed (e.g., it may be placed substantially perpendicular to said bone). The instrument (10) is rotated clockwise via the handle, with application of constant axial pressure. Care should be taken to keep the tap and tap sleeve perpendicular to the bone to prevent inadvertent dissociation of the tap from the bone. The tap sleeve is rotated in a clockwise direction until an appropriate depth is reached, after which the tap sleeve is rotated in a counterclockwise direction until it disengages from the bone. The tap sleeve is then removed from the instrument, revealing the anchor attached to the shaft.
The distal end (32) or tip of the anchor (30) is then placed substantially in alignment with the bone hole formed by the tap. The shaft (40) is rotated clockwise by the handle (70) with application of constant axial pressure. Care should be taken to keep the anchor perpendicular to the bone to prevent premature dissociation of the anchor from the shaft first end (40A). The shaft is rotated in a clockwise direction until the anchor disengages from the shaft first end (40A) and is fully installed in the bone. After disengagement, the handle doors may be opened and removed from the handle, thereby freeing the handle and attached shaft to be removed from the surgical site. The sutures, threaded through the suture anchor and having their first and second ends retained and organized by the cleats on the inner surface of each door, remain. Once disengaged from the cleats, the sutures are free to be employed at the user's discretion (
Should the user determine that the anchor must be loosened, disengaged, or even fully removed from its location in the bone, the shaft second end (40B) may be removed from the handle (70) and the shaft first end (40A) inserted into said handle. Then, using the removal prongs (49B) of the shaft second end (40B) and taking advantage of the deeper reach afforded the removal prongs (49B) by the shoulder (49C), the removal prongs (49B) are aligned with and inserted into the channels (35) of the anchor (30). Then, by counterclockwise rotation of the shaft (40) with application of constant axial pressure, the anchor may be reversed, thereby loosening, disengaging, or even fully removing the anchor from the bone hole.
TABLE 1 is provided below for the reader's convenience, listing the enumerated elements described above:
All references cited in this specification are herein incorporated by reference as though each reference was specifically and individually indicated to be incorporated by reference. The citation of any reference is for its disclosure prior to the filing date and should not be construed as an admission that the present invention is not entitled to antedate such reference by virtue of prior invention.
It will be understood that each of the elements described above, or two or more together may also find a useful application in other types of methods differing from the type described above. Without further analysis, the foregoing will so fully reveal the gist of the present invention that others can, by applying current knowledge, readily adapt it for various applications without omitting features that, from the standpoint of prior art, fairly constitute essential characteristics of the generic or specific aspects of this invention set forth in the appended claims. The foregoing embodiments are presented by way of example only; the scope of the present invention is to be limited only by the following claims.
