Suture retention devices and associated products and methods

A suture retention device includes a stack of suture engaging members which can be provided by coils or other segments of a spring. A suture engages with the stack so as to permit travel of the retention device along the suture in one direction more facilely than travel along the suture in the other direction. The retention device can include a housing that encloses the spring or other stack structure, and the suture can pass from a first hole in the housing, through the suture engaging members, and to a second hole in the housing. A suture anchor can be attached to the suture, and the resulting assembly can be combined with a needle designed to introduce the anchor and suture into patient tissue, e.g. in the conduct of a gastropexy procedure.

FIELD OF THE INVENTION

The present invention relates generally to medical devices, and in certain particular aspects to devices through which a suture is passed and which can selectively translate along or resist translation along the suture.

BACKGROUND

In the field of medicine there are often occasions in which a suture needs to be secured in a position or a condition selected by a doctor or other attending health care provider. Examples occur in surgeries in which a suture is used to approximate two different segments of tissue to one another, for example during a gastropexy procedure. In traditional gastropexy, the stomach wall of a patient is secured against the inner surface of the abdominal wall by one or more sutures passing from external of the patient, through the abdominal wall, through the stomach wall, and into the stomach. Oftentimes, an anchor, such as a T-bar anchor, is connected to that portion of the suture that resides in the stomach. With the anchor positioned against the inner stomach wall, the suture is tensioned from outside the patient to pull the stomach wall against the abdominal wall. At that point, the suture needs to be secured at a position external of the patient to maintain the applied tension. For these purposes, it is known to either stitch the suture to the skin of the patient, or to use a suture retention device connected to the suture that abuts against the skin of the patient and holds the tension. After securing an extended segment of the stomach against the abdominal wall with several such suture-anchor arrangements, a number of useful procedures can be conducted, usually involving intubating the stomach of the patient by passing a tube through the region where the abdominal wall and stomach that are held against one another.

It is desirable to conduct gastropexy surgeries and other similar tethering or tissue anchoring surgeries rapidly, efficiently, and safely. To accomplish these ends, there are needs for improved and alternative suture retention devices, and associated assemblies and methods.

SUMMARY

In certain aspects, the present invention provides devices and methods for retaining surgical tethers such as sutures. The devices and methods can involve a tether engaging stack structure including at least first and second adjacent stack members, such as coils of a spring, positionable external of a patient and operably coupled to a surgical tether that can be passed into a patient. The operable coupling can include a frictional securement of the position of the surgical tether by a clamping force between adjacent stack members of the stack structure. It should be appreciated that while not limited to such, embodiments of the present invention can be useful for performing a gastropexy procedure or other procedure in which an organ wall or other tissue wall is to be engaged by a tissue anchor and retained in a displaced condition (e.g. against another organ wall or tissue wall).

In one embodiment, provided is a surgical tether retention device that includes a housing having a first end and a second end, the first end defining a first end wall surface configured for receipt against an external patient surface and a first end wall opening. A tether engaging stack structure is retained by the housing, the stack structure including at least first and second adjacent stack members. A surgical tether is provided and has a housed tether portion extending through the housing in a path from the first end wall opening to a second opening spaced from the first end wall opening. The surgical tether has a first external tether portion extending out of the first end wall opening in a first direction external of the housing. The surgical tether has a second external tether portion extending out of the second opening in a second direction different from the first direction and external of the housing. The housed tether portion includes at least one tether segment received between the first stack member and the second stack member. The housed tether portion is cooperatively associated with the tether engaging stack so as to urge the first and second stack members away from one another when the housing is urged along the surgical tether in the first direction and to urge the first and second stack members toward one another when the housing is urged along the surgical tether in the second direction. The stack structure can include an integral structure, such as a spring, providing the first and second stack members.

In another embodiment, provided is a medical device that includes an elongate surgical tether and a tether engaging structure. The tether engaging structure includes at least first and second adjacent members and is cooperatively associated with the elongate surgical tether so as to compressively engage and retain the position of the tether relative to the stack when the tether is forced in a first direction relative to the stack but to allow travel of the suture through the stack when the tether is forced in a second direction relative to the stack. The tether engaging structure can include a spring providing the at least first and second adjacent members, and preferably one or more additional members. The device can also include a first wall member having a first wall member opening, and the surgical tether can be positioned passing through the first wall member opening. A tether anchoring element, such as a T-tag, can be attached to the surgical tether. The medical device can also include a needle configured to advance the surgical tether through patient tissue and, where the device includes a tether anchoring element, the anchoring element can be at least partially received within a lumen of the needle. In several embodiments, the stack structure can include at least a third stack member, wherein the surgical tether is received between the first and second stack members, and wherein the surgical tether is looped around at least the third stack member. Additionally, the surgical tether can have portions extending away from at least the third stack member, around which the surgical tether is looped, from opposing sides of at least the third stack member.

Another embodiment provides a device for securing a surgical tether that includes a surgical tether, a tether anchoring element attached to the surgical tether, and a tether retention device received on the surgical tether. The tether retention device includes a spring having a plurality of spring segments adjacent to one another, the plurality of spring segments including at least first and second spring segments adjacent to one another and at least a third spring segment. The tether retention device further includes a housing retaining the spring, the housing having a first wall portion defining a first opening and a second wall portion defining a second opening. The surgical tether passes through the housing of the tether retention device from the first opening to the second opening thereby providing a housed tether segment within the housing. The housed tether segment is received between the first and second spring segments and looped at least one time around the third spring segment. In certain embodiments, tension can be applied to the tether in a first direction so as to tension and expand the spring to reduce or eliminate a clamping force applied to the suture by a coil or coils of the spring, and allow the suture to travel through the spring. Release of the tension applied to the tether in the first direction allows the spring to contract to or toward its relaxed condition, such that the suture is again clamped between the first coil and one or more adjacent coils of the coil spring. Additionally, in certain embodiments, tension can be applied to the tether in a second direction that differs from the first direction, so as to apply compressive force to the spring and cause or increase a clamping force of the spring on the tether, to cause resistance to travel of the tether through the spring. The housing preferably encloses or surrounds the spring, e.g. so as to prevent direct contact of the spring by a user or by patient tissue in use. In several instances, the device can also comprise at least a fourth spring segment located between the second and third spring segments, and wherein the housed tether segment extends over an external surface of the fourth spring segment without looping around the fourth spring segment. Additionally, the device may comprise at least a fifth spring segment located adjacent the third spring segment, and wherein a portion of the surgical tether passes over an internal surface of the fifth spring segment without looping around the fifth spring segment.

Any suture or sutures disclosed herein may be any suitable bioabsorbable or non-bioabsorbable, multi-filament or monofilament suture. Similarly, any disclosed suture anchor(s) may, for example, be a “T-bar” or “T-tag” device or other device including an elongate rod structure, as is known for anchoring the end portion of a suture against a tissue wall, for example when tensioning the suture to approximate first and second tissues to one another, e.g. in a gastropexy procedure. Suitable suture anchors are known including for example those described in U.S. Pat. Nos. 5,123,914, 6,110,183 and 6,699,263, and those commercially available from Cook Medical, Bloomington, Ind. in products sold under the trade name Cope Gastrointestinal Suture Anchor Set.

It is also contemplated, and will be appreciated by those of skill in the art, that the herein disclosed surgical tether retention devices, not limited to those partially and/or entirely illustrated in the provided figures, may be used with the needle assembly and suture anchoring system illustrated and explained with regards toFIG. 6. Similarly, any of the disclosed tether retention devices may have a release mechanism, such as the manual release mechanism illustrated inFIG. 7.

The association of a surgical tether with tether engaging stack structure is arranged so that the application of a pull force on the surgical tether and/or pushing on the tether engaging stack structure in a direction retrograde (away from an anchor or the patient) along the surgical tether, or both, puts portions of tether engaging stack structure in compression. On the other hand, the application of a pulling force on surgical tether in a direction antegrade (toward an anchor or the patient) along surgical tether, or both, can longitudinally extend or expand portions of the tether engaging stack structure by putting the same in tension, thereby permitting travel of the surgical tether relative to the tether engaging stack structure. In several embodiments, modes of associating surgical tether with a tether engaging stack structure provide an arrangement wherein antegrade movement of the tether engaging stack structure is permitted due to tensile force imparted to expand portions of the tether engaging stack structure but retrograde movement of the tether engaging stack structure is prevented due to an inherent compressive force and/or bias between portions of the tether engaging stack structure,

Portions of surgical tethers described herein may, in several instances, comprise looped segments that can loop around a portion of a tether engaging stack structure, such as a spring coil. In these instances, the loop(s) may comprise a left-handed helix or a right-handed helix and may extend along a portion of the tether engaging stack structure in a direction towards or away from a secured end of the tether engaging stack structure or perpendicular to a longitudinal axis of the tether engaging stack structure. As will be appreciated, the direction in which the surgical tether is looped and/or extends along a portion of the tether engaging stack member may be arranged so that upon application of a pulling motion to slide portions of tether engaging stack member along a length of the surgical tether, portions of the surgical tether migrate from a first position to a second position along a length of one or more of the stack members of the tether engaging stack structure. In some instances, portions of surgical tether can migrate towards or away from a secured end of the tether engaging stack structure. As disclosed herein, associations of surgical tether(s) and tether engaging stack structure(s) may be arranged such that a risk of the surgical tether becoming disassociated with tether engaging stack structure during use of the device is decreased and/or eliminated. For example, the distance a looped portion must migrate along a stack member before becoming disassociated with the stack member may be increased and/or the ends of the of the stack members may be closed, such as by the stacking members comprising closed loops and/or the ends of a helically wound tether engaging stack structure being coupled to adjacent one or more adjacent stack members so that a looped portion of a surgical tether is not free to slide off the end of the helical structure. Alternatively or additionally, the surgical tether may be looped in a specific helical fashion and/or along a particular direction of a stack member.

As well, in embodiments employing a spring for a tether engaging structure, the spring may be a helically wound spring as illustrated herein, a flat spring, or any other spring configuration providing a plurality of segments for achieving the structural and functional requirements described herein. Any spring identified herein may, for example, be comprised of or constituted from a synthetic polymeric material or a suitable metal such as stainless steel, or combinations thereof, and may be positioned in any suitable orientation in the housing or relative to a patient surface. Likewise, other components of the suture retention device, of the needle or its components, can be comprised of or constituted from any suitable material including metal, polymeric material, or combinations thereof. The use of these and other variations will be within the purview of those of ordinary skill in the art.

Any reference to a housing or housing herein includes those arranged to enclose or surround one or more tether engaging stack structures, such as springs, to prevent user or patient contact therewith. The housing(s) could be omitted or other housing or wall arrangements could be used which partially shield the tether engaging stack structure(s) or partially enclose a portion or portions of the tether engaging stack structure(s). Disclosed housing(s) can also provide at least one surface disposed to face the patient in use, and at least one surface opposite thereto

It is also contemplated that housing portions disclosed herein may be arranged for coupling to one another and/or a tether engaging stack structure, such as by use of mechanical attachments including but not limited to bonding, screws, and/or interference/friction fitting portions. For example, one or more housing portions may comprise an elongate portion arranged to cooperate with a recess of the opposing housing when the housing portions are brought into cooperation. In several embodiments, the elongate portion may be secured within the recess with a mechanical fastener, as mentioned, such as an adhesive.

Components of disclosed embodiments, such as surgical tethers (e.g., sutures), anchors, tether engaging stack structures (e.g., springs), housings, and needle assemblies may be combined in various combinations or singly and enclosed within a sterile medical package(s). For example, at least two or more or all of these components can be arranged to operate with each other and may be combined and sealed within a package to be sold as a single medical product. Illustratively, such a medical product can have packaging including a backing layer and a front film layer that are joined by a boundary of pressure-adhesive as is conventional in medical packaging, wherein the contents of the packaging are sealed between the backing layer and front film layer. Sterilization of such a medical product may be achieved, for example, by irradiation, ethylene oxide gas, or any other suitable sterilization technique, and the materials and other properties of the medical packaging will be selected accordingly.

Additional embodiments include methods of use of devices as disclosed herein to secure a position of a surgical tether, and methods of manufacture of devices as disclosed herein. Still further embodiments of the invention as well as features and advantages associated therewith will be apparent to those skilled in the pertinent art from the descriptions herein.

DETAILED DESCRIPTION

With reference toFIG. 1, shown is one embodiment of a suture retention device of the present invention and elements that may be associated therewith. In particular, shown is suture retention device16having associated therewith a suture12and a suture anchor14. Suture12may be any suitable bioabsorbable or non-bioabsorbable, multi-filament or monofilament suture, and suture anchor14may, for example, be a “T-bar” or “T-tag” device or other device including an elongate rod structure, as is known for anchoring the end portion of a suture against a tissue wall, for example when tensioning the suture to approximate first and second tissues to one another, e.g. in a gastropexy procedure. Suitable suture anchors are known including for example those described in U.S. Pat. Nos. 5,123,914, 6,110,183 and 6,699,263, and those commercially available from Cook Medical, Bloomington, Ind. in products sold under the trade name Cope Gastrointestinal Suture Anchor Set.

With reference now toFIG. 2in conjunction withFIG. 1, shown inFIG. 2is a cross-sectional view taken longitudinally along the central axis of suture anchor device16. Anchor device16includes a coil spring18providing a suture retention stack including a plurality of closely spaced or adjacent stack members, retained with a housing20. Housing20includes a first generally cylindrical housing member22and a second housing member24capping housing member22. While the illustrated housing20encloses or surrounds spring18to prevent user or patient contact therewith, the housing could be omitted or other housing or wall arrangements could be used which partially shield the spring18or partially enclose a portion or portions of the spring18. The illustrated housing20defines an internal chamber26in which spring18is received. Spring18can be received in internal chamber26in a slip-fit or other close-fitting relationship that allows movement, preferably along a longitude of the spring, of at least some spring segments associated with suture12for suture release and compression functions as described herein. A close-fitting relationship of the spring18with the sidewalls of chamber26is desired so as to prevent any exaggerated laterally-directed bending of spring18during use of device16. Internal chamber26provides an amount of longitudinal head space beyond an end of the spring18in a direction in which the spring18is to be expandable as described herein (occurring to the left end of chamber26inFIG. 2), to leave room for such expansion. Housing20provides a first end surface28disposed to face the patient in use, and a second end surface30opposite thereto. Housing20includes sidewalls32extending between end portion28and end portion30. Device16also includes set screws34aand34bpenetrating sidewalls32and contacting spring18under compression along a portion thereof to fix the location of spring18within chamber26. It will be understood that other modes of fixing the relative location of spring18could also be used, including for example bonding or other mechanical attachments.

Suture12as associated with device16includes a first suture portion36located on a first (patient-facing) side of device16, a second suture portion38located on the opposite side of device16relative to portion36, and a third segment40occurring within housing20. As associated with housing20, suture12passes through opening42in the end wall defining surface28, through chamber26, and through opening44in the end wall defining surface30. As shown, the internalized suture segment40is associated with spring18through interaction with coils thereof, one embodiment of which is more particularly described below in association with the figures.

In that regard, referring now toFIGS. 3 and 4,FIG. 3shows the spring18in a somewhat extended or expanded configuration to better illustrate the pattern of association of suture12, and in particular its segment40, with spring18, whileFIG. 4shows the spring18in its relaxed configuration having individual coils thereof abutting one another and compressing the suture12at positions between spring coils. In the illustrated embodiment, the suture segment40includes a first segment portion46extending through a lumen defined by coil spring18. Segment40then passes between adjacent spring coils18aand18bto thereby extend to a second segment portion48that travels external of the spring18lumen and along the external surface of spring coils18b,18c, and18d. Segment40has a third segment portion50that is looped around spring coil18eat least one time, although use of either single loop or multiple loops, e.g. 2, 3, or 4 loops. This looping of segment40around a coil or coils of spring18occurs in certain embodiments in a region proximate to the proximal end of spring18, and can include a looping around the final end coil segment of the spring alone or in combination with one or more other adjacent coils. Thereafter, the internalized suture segment40extends as a fourth segment portion52from the loop(s) segment portion50and ultimately through opening44. In the preferred embodiment, the spring18in its relaxed state has closely abutting coils so as to provide compression on suture segment40at locations where segment40passes between adjacent ones of its coils.

The association of suture12, and in particular its internalized segment40, with spring18is arranged so that the application of a pull force on suture portion36, for example by pulling on suture portion36, pushing device16in a direction retrograde (away from anchor14or the patient) along suture12, or both, puts spring18in compression. When this occurs, additional compression is imparted to suture segment40at the location or locations at which it passes through adjacent coils of spring18, thus resisting travel of the suture12relative to spring18and thus relative to device16. In certain embodiments, the suture retention device16can thereby resist any significant travel (e.g. travel of more than about 0.5 cm, or travel of more than about 0.1 cm) of the suture relative to the spring and/or housing even upon the application of 20 Newtons of force by tensioning suture12so as to compress spring18.

On the other hand, the application of a pulling force on segment38of suture12, for example by pulling on suture portion38, pushing device16in a direction antegrade (toward anchor14or the patient) along suture12, or both, longitudinally extends or expands the coil spring18by putting the same in tension, thereby permitting travel of the suture12relative to the spring18and device16. In one operative mode, the expansion of the spring18upon the application of this tension separates at least some of the coils of spring18. In this regard, while travel of the suture12is permitted during application of this pull force, the sliding frictional engagement of coil spring18eby loop(s) is sufficient to transmit enough of the pull force to coil spring18to achieve separation of the necessary coils to ease suture travel. Continued pulling force applied to suture12at segment38continues translation of suture12through device16, thus allowing an operation in which device16is translated antegrade along suture12toward suture anchor14. This can be used in a securing procedure for anchor14as discussed further below. In certain embodiments, the suture retention device16allows travel of the suture12relative to the housing20and/or spring18upon the application of no greater than about 10 Newtons of force by tensioning suture12so as to expand spring18, e.g. by a pull force applied to segment38. When the pull force applied to segment38is discontinued, spring18returns to its relaxed configuration (seeFIG. 4). Any subsequent attempt to force the device16retrograde along suture12will again put spring18in compression and cause a resistance to retrograde travel along suture12as discussed above.

It will be understood thatFIGS. 1 to 4depict one mode of associating suture12with spring18to provide an arrangement wherein antegrade movement of device16is permitted due to tensile force imparted to expand the spring18but retrograde movement of the device16is prevented due to compressive force applied to spring18. In certain embodiments, as exemplified in the illustrated embodiment, the suture12will be looped around a coil or a group of coils (typically adjacent coils) to provide a sliding frictional engagement of the coil(s) during application of a force to translate the device16antegrade along suture12, and to provide a retaining frictional engagement (with essentially no sliding of the suture12) of the coil(s) during application of a force that would tend to translate the device16retrograde along suture12. This retaining frictional engagement can apply a compressive force to spring18and thereby apply compression or further compression upon segments of suture that pass between coils that occur antegrade on the spring18relative to the point of frictional engagement by the loop(s) (e.g. on the suture segment that extends between coils18aand18bofFIGS. 3 and 14). Variations of these and other suture travel patterns through and/or around coils of spring18, or other springs, will be within the purview of those of ordinary skill in the field given the teachings herein.

FIG. 5provides an illustration of an implanted suture anchoring system incorporating the suture retention device ofFIGS. 1 to 4, as can occur in a gastropexy procedure in which a stomach wall200is held close to or against an abdominal wall202. Particularly, this is accomplished by suture12passing through both walls200and202, with anchor14positioned against an inner wall surface204of stomach wall200, and suture retention device16received against the external surface206(e.g. skin) of the patient and secured to suture12. The suture12is held in tension, with the suture retention device16secured thereon and preventing retrograde travel of device16along suture12through the interaction of the suture12with spring18(seeFIGS. 2-4) of device16. Antegrade travel of device16along suture12is permitted as discussed above, which has allowed the physician or other health care provider to move device16along suture12down toward and against the external surface206.

With reference now toFIG. 6, shown is a needle assembly60incorporating a suture retention combination, such as that as shown inFIG. 1. Needle assembly60includes a needle cannula62defining a lumen64therethrough and having a tissue penetrating distal tip66and a proximal hub68. Hub68can optionally incorporate a mechanism for connection to a syringe or other fluid delivery device, for example an internal thread pattern as associated with conventional Luer-lock connectors. Needle cannula62has a distal region having a slot70defined therein communicating with lumen64and extending distally to the distal edge72of cannula62. Suture anchor14is received within lumen64with a portion of anchor14exposed through slot70. Suture12is received against an upper edge70aof slot70, where upper edge70ais so configured as to avoid cutting or tearing suture12during use of assembly60. Suture12passes adjacent to and external of needle cannula62to the region of hub70. Desirably, suture12is removably secured in the region of the hub to ease use of needle assembly60during advancement of needle cannula62into patient tissue. This securement can be accomplished in any suitable fashion, for example with removable tape, bonding agents, or reversible mechanical fasteners. In the illustrated embodiment, a mechanical fastener is provided by an annular member74mounted around hub70and having a slit76communicating with an outer periphery thereof, for receiving and frictionally securing the position of suture12in the slit76. Suture12can be pulled to disengage suture12from slit76when desired. For these purposes annular member74can be made of a polymeric material, desirably an elastomeric material, such as silicone rubber. Device16is received on suture12, e.g. as discussed hereinabove. Needle assembly60can also be provided (e.g. in a kit) in conjunction with an elongated pusher80such as a straight wire guide structure, which can be passed through hub70and distally down the lumen64to deploy anchor14after the needle cannula62has been advanced to the desired position.

In use, needle assembly60can be used to advance and deploy anchor14in a desired location in a patient. In a gastropexy procedure, the stomach of the patient is typically insufflated, and the distal tip of the needle cannula62is passed through the patient skin and abdominal wall and into the stomach. The suture anchor14is then deployed, for example using pusher80passed through the lumen64of cannula62. The needle can then be withdrawn, leaving anchor14implanted within the stomach of the patient and suture12threading through the needle tract and out of the patient. Suture retention device16is attached to the suture external of the patient and spaced from the patient's skin. Retention device16can then be slid down suture12toward the skin of the patient, and lodged against the skin of the patient to leave suture12in tension, with stomach wall200pulled toward and against abdominal wall202. Most often, several (e.g. 2, 3, or 4) such anchors are set in place in the stomach of the patient, to approximate a region of the stomach wall against the abdominal wall. Surgical procedures accessing the stomach can then be conducted through the approximated stomach wall region, for instance to implant feeding tubes or tubes for other therapeutic or diagnostic medical purposes.

Referring now toFIG. 7, shown in another embodiment of a suture retention device16′ of the invention. Suture retention device16′ includes features similar to those of device16ofFIGS. 1-5, which are similarly numbered. Suture retention device16′ also includes a manual release mechanism which, when actuated, allows a user to slide device16′ along suture12in the direction that would otherwise be resisted as discussed hereinabove. Manual release mechanism90includes a pull tether92, for example a segment of suture material, that is attached to spring coil18z, for example including a looped tether segment94around coil18z(e.g. formed in tying tether92to coil18z). Release mechanism90also desirably includes a knob96or other grip element attached to pull tether92. Pulling on knob96tensions spring18, thereby urging a separation of coils18zand18a-18ethat can counteract the tendency for travel of device16′ along suture12in the direction of suture segment38to compress spring18and clamp the suture12, thus allowing travel of device16′ in such direction during actuation of release mechanism90. In this manner, if a physician or other user, in setting the final position of device16′, wishes to move device16′ away from anchor14(e.g. away from the patient), knob96can be pulled during such movement to allow repositioning of device16′. Release of knob96will put device16′ again into its condition in which travel in the direction away from anchor14is prevented. If desired, after device16′ has been placed in its final, desired position, tether92can be cut to remove knob96to help avoid any accidental movement of device16′ away from anchor14or release of suture12during subsequent procedural steps or convalescence periods.

The arrangement illustrated inFIGS. 8 and 9operates in a similar manner as the arrangement illustrated inFIGS. 3 and 4. A surgical tether (e.g., suture12) extends between two or more stack members (e.g., spring coils18cand18d) of a tether engaging stack structure and is arranged with the stack members to separate at least two of the stack members between which the surgical tether extends when pulled in a first direction (e.g., towards second suture portion38) but not to separate the at least two stack members when pulled in a second direction (e.g., towards first suture portion36). In some instances, the stack members may be biased towards one another (e.g., a coil spring) with the stack members permitted to expand in a first direction (e.g., towards a head space defined by a housing) but not in a second direction. As illustrated, in embodiments that use one or more tension coil springs, a portion of the coil spring may simply be secured to the housing, preferably an end of the coil spring, so that expansion of the coil spring is only permitted in a direction extending away from the secured end.

With reference now toFIG. 8in conjunction withFIG. 9, shown inFIG. 8is a coil spring18in a somewhat extended or expanded configuration (as it might look if the spring18was subjected to tension to spread the coils apart) to illustrate another arrangement for the of association of suture12, and in particular its segment40, with spring18. In the illustrated embodiment, the first segment portion46of suture segment40extends through a lumen defined by coil spring18. Segment40then passes between adjacent spring coils18aand18bto thereby extend to a second segment portion48that travels external of the spring18lumen and along the external surface of multiple spring coils, spring coils18band18c. Similar to the pattern illustrated inFIG. 3, a third segment portion50of segment40is looped around a spring coil, spring coil18d, at least one time. Thereafter, unlike in the arrangement illustrated inFIGS. 3 and 4, the fourth segment portion52of internalized suture segment40extends from the loop(s) segment portion50on an opposing side of the spring coils than second segment portion48and through the lumen defined by coil spring18and ultimately through an opening in the housing.

As will be appreciated, loop segment portion50of suture segment40may loop around a spring coil in a number of directions. In some instances, for example, suture segment40may be wound in a left-handed helix and/or a right-handed helix along a length of one or more spring coils that extend along a helical path towards or away from a first spring end19of the coil spring18. For example, as illustrated inFIGS. 8 and 9, the loop segment portion50can extend over the external surface of spring coils18a,18b, and18cbefore reaching spring coil18d. After reaching spring coil18d, the suture segment portion50extends along the external surface of spring coil18dbefore extending between spring coils18dand18eand into the lumen defined by spring18. When segment portion50extends from within the lumen defined by the coil spring18(i.e., emerging between spring coils18cand18dto form one or more loops), suture segment40is positioned to the left side of the second segment portion48, forming a right-handed helix and extending along a helical path away from the first spring end19and segment portion48.

As illustrated in theFIGS. 8 and 9, the spring coils of the spring18are angled (i.e., the helix angle) away from the first spring end19. As will be appreciated, upon application of a pulling motion on suture portion38, portions of segment portion40extending between spring coils of spring19can, in some instances, migrate along a length of one or more spring coils in a helical fashion towards suture portion38and/or away from first spring end19. Should looping segment portion50migrate past the top end of the spring18and off the end of a spring coil, the suture retention device may no longer operate as intended and may need to be discarded. Advantageously, it has been found that looping segment portion50around a spring coil in a direction away from the first spring end19and/or an adjacent suture segment closer to the anchor14, such as a helical path as illustrated inFIGS. 8 and 9, can decrease the migration of the looping segment portion50along spring18towards the second suture portion38and/or away from the first spring end19when a pulling force is applied on segment38of suture12, when device16is pushed in a direction antegrade along suture12, or both. As described in more detail above, when such force is applied to the suture12and/or the pushing device16, the coil spring18expands and permits travel of the suture12relative to the spring18. By looping the suture segment40around a spring coil in a direction away from the segment portion48, adjacent loop portions or loops of suture segment40on a spring coil will tend to spread apart from one another and/or towards the free end of spring18.

Alternatively, suture segment40ofFIGS. 8 and 9may be wound along a length of a spring coil in a direction towards the segment portion48(e.g., with the suture segment40emerging to the right side of second segment portion48from within the lumen). In these instances, the adjacent portions of the suture segment40on a coil spring may tend to migrate along a helical length of the spring18with the loop portion closer to the first spring end19along the helical path of the spring coil pushing the loop portion further from the first spring end19towards suture portion38upon movement of the coil spring18in an antegrade direction along suture12. However, arrangements prone to migration of looping segment portion50are still suitable for the retention of surgical tethers, and the risk of a portion of suture segment40disassociating with the spring18, such as looping segment portion50migrating off an end of spring18, may be decreased by positioning one or more spring coils, such as spring coil18e, between looping segment portion50and suture portion38, as illustrated inFIGS. 8 and 9, so that looping segment portion50must travel a greater helical distance before sliding off an end of the spring18. Therefore, although it may be preferred in some instances that portions of suture segment40that form one or more loops, such as segment portion50, are helically wound around an axis extending away from segment portion48and/or towards segment portion52, other arrangements are suitable.

Turning now to another portion of an exemplary surgical tether retention device,FIGS. 10 and 11illustrate a suture retention deice100comprising a first housing member102, a second housing member104, and a coil spring106. First and second housing members102,104are arranged so that the two define an internal chamber108arranged to receive the coil spring106and allow the expansion thereof. Similar to the device illustrated inFIGS. 1 and 2, first and second housing members102,104, when brought into cooperation, can enclose or surround the spring18to prevent user or patient contact therewith and can comprise one or more surfaces disposed to face the patient in use. Similarly, spring18can be received in internal chamber108in a slip-fit or other close-fitting relationship that allows movement along a longitude of the spring18.

FIGS. 12A,12B, and12C illustrate the first housing member102in more detail.FIG. 12Aillustrates a plan view of the inside of the first housing member102, andFIGS. 12B and 12Cillustrate partial cross-sectional views taken along lines12B-12B and12C-12C ofFIG. 12A. As illustrated, first housing member102comprises a first elongate portion110and a second elongate portion112that extend in a parallel fashion away from a central portion of the first housing member102. A first base114of the first elongate portion110is supported by supporting members118a,118b,118c, and118d, and, similarly, a second base116of the second elongate portion112is supported by supporting member120a,120b,120c, and120d.

A perimeter wall134extends around the perimeter of the first housing member102and comprises and end surface136arranged for contacting a portion of the second housing member104. Perimeter wall134also comprises a side surface138that defines recesses140and142arranged to receive portions of the second housing member104. Additionally, first and second elongate portions110,112may have side surfaces122,124arranged to contact portions of the second housing member104.

FIGS. 13A,13B, and13C illustrate the second housing member104in more detail. Similar toFIGS. 12A-C,FIG. 13Aillustrates a plan view of the inside of the second housing member104, andFIGS. 13B and 13Cillustrate partial cross-sectional views taken along lines13B-13B and13C-13C ofFIG. 13A. As illustrated, second housing member104has walls150,152with inner surfaces154,156that define recesses158,160arranged to receive the first and second elongate portions110,112of the first housing member102. In some instances, when the first and second housing members102,104are brought into mating cooperation, inner surfaces154and156of the second housing member104contact side surfaces122,124of the first and second elongate portions110,112. Additionally or alternatively, the interaction between surfaces154,156and122,124may be arranged to lock the first and second housing members102,104to one another. For example, one or more of these surfaces of the housing members may be bonded to one another, such as by use of an adhesive, just to name one non-limiting example.

Second housing member104also has a perimeter portion defining surface162arranged to contact the end surface136of perimeter wall134of the first housing member102and provide a smooth exterior transition between the first and second housing member102,104when the first and second housing members102,104are brought into mating cooperation. Additionally, outer portions164,166of walls150,152can be arranged to coincide with recesses140,142of the first housing member102when the housing members102,104are brought into cooperation.

Second housing member104comprises a spring retention portion170. Spring retention portion170comprises outside surface172and inside surface174that define an annular spring receiving recess176arranged to receive a first spring end19of a coil spring18and couple the spring18to the second housing member104. In some embodiments, outside surface172of the spring retention portion170presses inward on the exterior surface of the spring18and/or inside surface174extends into the lumen of a spring18and presses outward on the interior surface of the spring18to couple the spring18to the second housing member104. Additionally or alternatively, as discussed with regards to other embodiments, other mechanical attachments such as set screws and/or adhesives, may be used to fix the relative location of spring18.

FIGS. 14A and 14Billustrate the first housing member102and the second housing member104in mating cooperation with one another. As can be seen, the first and second housing members102,104define an internal chamber108arranged to receive and allow expansion of a spring18. Additionally, similar to the other illustrated and disclosed embodiments, openings180and182allow a surgical tether to extend into the internal chamber108, such as through opening180, to associate with a stack members, such as spring coils, and then exit the internal chamber108through opening182.

Descriptions hereinabove have been made with reference to suture12as an illustrative and preferred surgical tether. It will be understood, however, that other surgical tether materials are also contemplated in accordance with the invention, including for example any elongate strand or flexible element, the position of which is desired to be secured. These may include, for example, setons, yarns, and elongate natural or synthetic segments, used in surgical procedures. As well, while reference has been made herein to the preferred use of a spring for providing a plurality of closely spaced material segments that cooperate to secure the suture, in other embodiments contemplated, any integral structure or any plurality of separate (non-integral) structures that can move away from or toward one other to cooperate with and releasably engage the suture or other surgical tether as described herein may be used. For example, stack members may be arranged so that when pulled in a first direction (e.g., towards anchor14) the surgical tether compresses one or more adjacent stack members (e.g., spring coils18cand18d) between which a portion of the surgical tether extends and when pulled in a second direction (e.g., towards second suture portion38) may not compress the one or more adjacent stack members between which it extends and/or separates the one or more adjacent stack members between which it extends, thereby allowing the surgical tether to travel against less frictional resistance.

In further aspects, product embodiments disclosed herein can be enclosed in suitable medical packaging such as trays, pouches, or other enclosing arrangements, and terminally sterilized using any suitable technique. The various products disclosed herein (e.g. suture retention devices, sutures or other tethers with or without attached anchor members, needles, pushers) may be packaged alone or together with one another in such medical packaging. Terminal sterilization techniques may include, as examples, sterilization with ethylene oxide gas (EtO) or by irradiation.

While the invention has been illustrated and described in detail in the drawings and foregoing description, the same is to be considered as illustrative and not restrictive in character, it being understood that only the preferred embodiment has been shown and described and that all changes and modifications that come within the spirit of the invention are desired to be protected. In addition, all references cited herein are indicative of the level of skill in the art and are hereby incorporated by reference in their entirety.