Patent Description:
It is known to retain surgical suture material having needles affixed at one or both ends in packages, also referred to as suture packages. Those packages typically are provided with a winding channel extending along an oval-shaped, in particular a stadium-shaped (rectangular with semi-circular ends) path in which the suture material is inserted. Further, these packages comprise at least one needle holder or needle park for holding the needle(s).

<CIT> discloses a package for surgical suture material having at least one needle affixed thereto, the package comprising a base member with at least one needle holder. The needle holder comprises a resilient tension element in the formed of an arm and a bearing serving as a counterbearing, which is connected fixedly to the base member. The arm has two ends, wherein a first end is connected fixedly to the base member and a second end is free, so that the arm is pivotable in a pivoting plane parallel to the base member. At the second end, a stop is provided. The second end of the arm in a neutral, undeformed state of the arm is arranged next to the bearing with a back side of the stop facing the bearing. For clamping a needle, the arm is resiliently deformed and the second end is moved across the bearing such that a front side of the stop faces the bearing, wherein the needle can be clamped between the bearing and the stop.

<CIT> shows a package for surgical suture material with a base and a needle park comprising two cantilevered arms, which extend horizontally above the base.

<CIT> shows a package for surgical suture material with a needle support structure including a relatively inflexible leg having a notch thereon for supporting a first portion of the surgical needle and one or two relatively flexible legs for engaging and biasing the surgical needle within the notch at second and third portions of the surgical needle.

<CIT> shows a package for surgical suture material with a cover having needle parks on the outer surface thereof, which needle park includes three cantilevered members that provide a three-point contact with the needle.

It is the object of the present invention to provide a needle holder for a package for surgical suture material ensuring a secure holding of a needle. It is further the object of the present invention to provide a package for surgical suture material having a needle holder.

According to a first aspect, a needle holder for securing a needle in a package for surgical suture material is provided, the needle holder having a nose protruding from a base plane, and two arms, which are resiliently deformable and/or displaceable in a plane parallel to the base plane, wherein the arms are each provided with a stop for contacting the needle, wherein the stops are arranged at opposite sides of the nose, wherein a front end of the nose is serving as a counterbearing for the needle between the two stops, wherein the arms are adapted for forcing the needle contacted by the stops against the front end of the nose, wherein the arms are L-shaped comprising a pivotally mounted lever with a first end serving as a pivot mount, and a second end, wherein in a plane parallel to the base plane the stop protrudes from the second end towards the nose, and wherein in a neutral initial position the levers of the arms extend perpendicular to the nose and the stops extend parallel to the nose. The two stops and the nose contact the needle in three contact regions, ideally in three contact points, thus allowing for a secure clamping of the needle in the needle holder.

The arms and the nose in one embodiment are formed integrally with a base member of a package, wherein a top surface of the base member forms the base plane. In other embodiments, the needle holder is formed separately and mounted to the base member. The arms are pivotally mounted, wherein the arms are pivotable in a pivoting plane parallel to the base plane.

The arms are L-shaped comprising a pivotally mounted lever with a first end serving as a pivot mount, and a second end, wherein in a plane parallel to the base plane the stop protrudes from the second end towards the nose. In the context of the application, the expressions "first", and "second" is not to be interpreted as defining a serial or numerical limitation but instead is only used to distinguish or identify various members of a group. A pivot mount in one embodiment is achieved by a flexure bearing between the base plane and the arm formed integrally with the base plane.

An optimal arrangement of the arms with respect to the nose can be chosen by the skilled person among others in consideration of a form of a needle to be clamped. For example, a position may be chosen different for a straight needle than for bent needles.

The arms are arranged such that in neutral initial position the levers of the arms extend perpendicular to the nose and the stops extend in parallel to the nose. This arrangement allows for a secure clamping of a curved needle by pivoting the levers against restoration forces out of the neutral initial position.

In embodiments, the arms are mirror-symmetrically arranged in relation to the nose, wherein in particular the arms are identical in design. The mirror-symmetric arrangement ensures equal forces to be applied by both arms without the need for complex calculations or tests when designing the arms of the needle holder.

In one embodiment, the nose is provided on a rib having a slot for receiving the needle. This design facilitates an insertion of the needle into the needle holder in manufacturing.

According to a second aspect, a package for surgical suture material is provided, the package comprising a base member with at least one needle holder as described above. The needle holder can be advantageously combined with different types of packages, for example with a package described in <CIT>. In embodiments of the invention, the base member is formed integrally with the needle holder for example by injection molding, wherein in particular the nose and the arms are formed integrally with the base member. In this case, for example flexure bearings are provided for pivotally connecting the arms at the second ends to a top surface of the base member.

In one embodiment, the package further comprises a base member and a cover member, wherein the base member has a plurality of pins protruding from a top surface and the cover member has pin receiving holes, which pin receiving holes are adapted for receiving the pins of the base member for mounting the cover member to the base member. A connection of the base member and the cover member is chosen by the skilled person considering among others a material of the base member and the cover member. In one embodiment, the base member and the cover member are both made of plastic material, wherein the cover member is welded to the base member for example applying ultrasonic welding technologies. In other embodiments, the cover member is secured to the base member using a snap-in fixture. For this purpose, the pins in one embodiment are provided with a head, which is larger in diameter than the pin receiving holes. In still another embodiment, a rivet fixture is provided, wherein pins, which not necessarily have a larger diameter head, are provided, which pins are deformed after placing the cover member on the base member for securing the cover member to the base member. A snap-in fixture or a rivet fixture are advantageous as such a fixture imposes less restriction on the choice of raw materials used for manufacturing the base member or the cover member. The height of the pins is chosen such that after a connection of the cover member and the base member the pins do not or only marginally protrude from a top surface of the package. In particular when fixing the cover member to the base member using a rivet fixture, distal ends of the pins are deformed such that a head having a larger diameter is formed and the pins are shorter in height than before the deformation. In this case, after a connection of the cover member and the base member only the larger diameter heads of the pins protrude from a top surface of the package.

In one embodiment, the cover member is provided with a plurality of guiding holes, which guiding holes are arranged between the pin receiving holes and an outer circumference of the cover member and are adapted for receiving winding pins of a winding apparatus, wherein at least one of the pin receiving holes forms as a common opening together with a neighboring guiding hole. The guiding holes are adapted for receiving winding pins of a winding head of a winding apparatus as described for example in <CIT>. Providing a common opening for the guiding holes and the pin receiving holes allows optimizing an area of the cover member, which is occupied by guiding holes and/or pin receiving holes. In one embodiment, the winding pins are received in the common opening during manufacturing, in particular during winding of the suture material, wherein after the winding is completed the winding pins are withdrawn from the guiding holes and only after the withdrawal of the winding pins, the pins of the base member are inserted. In other embodiments, a guiding hole and a pin receiving hole are merged for forming one common opening, which is larger in size than either one of the guiding hole and pin receiving hole taken separately. The cover member having at least one common opening for receiving a winding pin and/or a pin of a base member is also advantageous for other packages for surgical suture material than the one described above, for examples packages not having a needle holder or packages provided with different needle holders, including for example, but not limited to, needle holders described in <CIT>. When providing larger size common openings, the cover member can be mounted to the base member before a winding of the suture material, wherein the cover member is slightly lifted and deflected for an introduction of the suture material into the channel.

In one embodiment, the pin receiving holes and the guiding holes in each case are arranged along an oval path having semi-circular ends, wherein the pin receiving holes arranged in the region of the semi-circular ends at least partly form common openings together with the respectively associated neighboring guiding holes. The shape of the oval path is in particular in embodiments of the invention geometrically similar to the basic shape of the package.

In one embodiment, the pin receiving holes arranged in the region of the semi-circular ends are at least partly arranged radially inward of the respectively associated neighboring guiding holes of a common opening. Thereby, a distance between a pin receiving hole and a guiding hole of a common opening is minimized, which allows to maximize the unperforated or punctured surface of the cover member and to improve a stability of the cover member.

In one embodiment, a radius of a first semi-circular end of the oval path of the pin receiving holes is larger than a radius of a second semi-circular end of the oval path of the pin receiving holes, wherein in particular the pin receiving holes arranged at the first semi-circular end partly overlap with the associated neighboring guiding holes for forming the common openings and the pin receiving holes arranged at the second semi-circular end are connected to the associated neighboring guiding holes via bridges for forming the common openings. In one embodiment, the pin receiving holes and the guiding holes in each case have a circular basic shape. In other embodiments, at least one of the pin receiving holes and the guiding holes has a non-circular basic shape.

In one embodiment, upon winding a suture material to the package, winding pins are inserted from above through the guiding holes of the cover member, wherein distal ends of the winding pins contact a top surface of the base member, thereby forcing the base member away from the cover member for forming or increasing a gap between the cover member and the base member. In another embodiment, the base member is provided with a plurality of guiding holes arranged in alignment with the guiding holes of the cover member. Hence, winding pins of a winding apparatus can be inserted through the guiding holes of the cover member and/or the base member from above or below the package.

In one embodiment, the pins protruding from a top surface of the base member are arranged along a separation wall protruding from the top surface of the base member, which separation wall separates a winding channel of the package from a center area. In one embodiment, a height of the separation wall defines a distance between the cover member and the base member, wherein the separation wall delimits a winding channel of the package from a center area.

In one embodiment, the needle holder is provided at the center area, wherein the separation wall has an opening permitting a passage of the suture material. In particular, in one embodiment, a needle holder is accessible by a user from a cut-out in the cover member for accessing the needle holder and removing the needle clamped in the needle holder, wherein upon removing the needle a suture material attached thereto is pulled out the winding channel though the opening in the separation wall.

In one embodiment, the base member and the cover member contact each other at their outer circumferences. In one embodiment, the base member and the cover member at their outer circumferences are provided with interlocking teeth and notches. The teeth and notches provide a barrier to hinder a suture material retained in a winding channel between the base member and the cover member from getting out of the winding channel.

A material of the cover member and the base member can be chosen by a skilled person considering health regulations, environmental compatibilities and/or other restrictions. In one embodiment, the cover member is made from paper material. Paper material is environmental compatible and has advantageous absorbent properties.

In the following, an embodiment of the invention will be described in detail with reference to the drawings. The drawings schematically show.

<FIG> shows in a top view a package <NUM> for surgical suture material (not shown) comprising a cover member <NUM> and a base member <NUM>. The cover member <NUM> is shown in isolation in <FIG>. The base member is shown in isolation in <FIG>.

In the embodiment shown, the cover member <NUM> and the base member <NUM> both have an oval shape. More particular, in the embodiment shown, the cover member <NUM> and the base member <NUM> both are stadium-shaped, i.e. in the shape of a rectangular with two opposing semi-circular ends.

The cover member <NUM> is attached to the base member <NUM>, wherein a winding channel <NUM> (see <FIG>) is formed between the cover member <NUM> and the base member <NUM>. The cover member <NUM> and the base member <NUM> are at least essentially congruent. More particular, in the embodiment shown, the base member <NUM> is provided at its outer circumference with a rim <NUM> and the cover member <NUM> is inserted into a space defined by the rim <NUM>. The rim <NUM> has inwardly protruding teeth <NUM>, which engage or interlock with notches <NUM> provided at an outer circumference <NUM> of the cover member <NUM>. Hence, the rim <NUM> confines the winding channel <NUM> for retaining a suture material inside the winding channel <NUM>.

The base member <NUM> is provided with a needle holder <NUM>, which is shown in more detail in <FIG>.

The needle holder <NUM> shown in the figures comprises a nose <NUM> and two L-shaped arms <NUM>, which are arranged at opposite sides of the nose <NUM>. In the embodiment shown, the arms <NUM> are mirror-symmetrically arranged in relation to the nose <NUM>. The arms <NUM> are resiliently deformable out of a neutral initial position shown in <FIG> in a plane parallel to the drawing plane, i.e. in a plane parallel to a top surface of the base member <NUM>.

Each arm <NUM> comprises a lever <NUM> and a stop <NUM>. In the neutral initial position shown in <FIG>, the levers <NUM> are arranged so as to extend perpendicular to the nose <NUM>. A first end <NUM> of each of the levers <NUM>, which is facing away from the nose <NUM>, is connected to the top surface of the base member <NUM>. The connection in one embodiment is achieved by forming the arms <NUM> integrally with the base member <NUM> wherein a flexure bearing is provided between each arm <NUM> and the base member <NUM>. The first ends <NUM> serve as a pivot mount for the levers <NUM>, which are pivotable about an axis perpendicular to the top surface of the base member <NUM> about the pivot mount.

A stop <NUM> is provided at a second end <NUM> of each lever <NUM>, which stop <NUM> in the embodiment shown protrudes from the lever <NUM> in a direction parallel to the top surface of the base member <NUM> and extends in parallel to the nose <NUM> towards the nose <NUM>. The stops <NUM> of the two arms <NUM> are arranged at opposite sides of the nose <NUM>. Upon deformation of the arms <NUM> out of the neutral initial position shown in <FIG>, a restoration force will force a needle contacted by the stops against a front end of the nose <NUM>, which front end is serving as a counterbearing for the needle. This allows to securely clamp a needle between the stops <NUM> and the nose <NUM>.

In the embodiment shown, the nose <NUM> is provided on a rib <NUM> having a slot <NUM> for receiving a needle. In other words, a needle can be inserted in the slot <NUM> and forced against the nose40 by means of the arms <NUM>.

In <FIG>, a needle <NUM> retained in the needle holder <NUM> is schematically shown by a dotted line. For removing the needle <NUM> from the needle holder <NUM>, the needle <NUM> is accessible via a cut-out <NUM> in the cover member <NUM>. Adjacent to the needle holder <NUM>, the base member <NUM> is provided with a slit <NUM> for easing a deformation of a region of the base member <NUM> when grasping the needle <NUM>.

The needle holder <NUM> can be combined with different types of suture packages. In the embodiment shown, the cover member <NUM> is fixed to the base member <NUM> using a pin connection, which pin connection is described in more detail in the following. The pin connection described below is also advantageous for other types of packages for surgical suture material with or without a needle holder <NUM>.

The base member <NUM> (shown in detail in <FIG>) is provided with a plurality of pins <NUM> which are protruding from a top surface of the base member <NUM>. As best seen in <FIG>, in the embodiment shown, the pins <NUM> extend beyond an upper end of the rim <NUM>. The pins <NUM> are arranged along a separation wall <NUM>, which separation wall <NUM> also protrudes from the top surface of the base member <NUM>. The separation wall <NUM> separates the winding channel <NUM> from a center area <NUM> of the base member <NUM>. In the embodiment shown, two additional pins <NUM> are provided, which are arranged inside of the separation wall <NUM>. In addition, in the embodiment shown a transverse wall <NUM> is provided, which extends between two long sides of the separation wall <NUM> across the center area <NUM>. The needle holder <NUM> is arranged in the center area <NUM>, wherein the separation wall <NUM> has an opening permitting a passage of the suture material between the winding channel <NUM> on the outside of the separation wall <NUM> and the needle holder <NUM>.

As best seen in <FIG>, the base member <NUM> is further provided with a plurality of guiding holes <NUM>, which are adapted for receiving winding pins (not shown) of a winding head of a winding apparatus as described for example in <CIT>. The guiding holes <NUM> are arranged outwardly of the separation wall <NUM>. In addition, two central guiding holes <NUM> are arranged inwardly of the separation wall <NUM> along a center line of the base member <NUM>. In the embodiment shown, the central guiding hole <NUM> provided at a right side in <FIG>, which is arranged closer to the needle holder <NUM> is a formed as an oblong hole. All other guiding holes <NUM>, <NUM> have a circular basic shape.

The cover member <NUM> is provided with a plurality of pin receiving holes 22a, 22b, <NUM>, <NUM>, which pin receiving holes 22a, 22b, <NUM>, <NUM> are adapted for receiving the pins <NUM>, <NUM> protruding from the top surface of the base member <NUM> when inserting the cover member <NUM> inside the rim <NUM> of the base member <NUM>. In the embodiment shown, a rivet fixture is provided, wherein the pins <NUM>, <NUM> are inserted in the pin receiving holes 22a, 22b, <NUM>, <NUM> and distal ends of the pins <NUM>, <NUM> are deformed after the insertion for a form-locking, in particular using heat created by ultrasonic energy. Thereby a reliable connection is achieved. In alternative embodiments, the pins <NUM>, <NUM> are glued or welded to the cover member <NUM>.

The cover member <NUM> is further provided with a plurality of guiding holes <NUM>, which guiding holes are arranged between the pin receiving holes 22a, 22b and the outer circumference <NUM> of the cover member <NUM>. The guiding holes <NUM> are adapted for receiving the winding pins (not shown) of the winding head of the winding apparatus as described for example in <CIT>.

A first set of pin receiving holes 22a, 22b, <NUM> is arranged along an oval path having semi-circular ends. The oval path is congruent to a curvature of the separation wall <NUM> of the base member <NUM>. Two additional pin receiving holes <NUM> are arranged inwardly of the oval path, which upon mounting the cover member <NUM> to the base member <NUM> receive the additional pins <NUM> arranged inwardly of the separation wall <NUM>.

The guiding holes <NUM> of the cover member <NUM> are also arranged along an oval path having semi-circular ends. In the embodiment shown, the pin receiving holes 22a, 22b arranged in the region of the semi-circular ends are at least essentially arranged radially inward of the respectively associated neighboring guiding holes <NUM>. Further, in the embodiment shown, all pin receiving holes 22a, 22b arranged in the region of the semi-circular ends of the oval path in which the first set of pin receiving holes 22a, 22b, <NUM> is arranged form common openings together with the respectively associated neighboring guiding holes <NUM>. Providing common openings, which function as pin receiving holes 22a, 22b and guiding holes <NUM> is advantageous for optimizing a perforated area of the cover member <NUM>. This allows for example to increase a stability of a cover member <NUM>, in particular when made of a paper material, and/or to maximize an area used for printing.

In the embodiment shown, the semi-circular ends of the oval path along which the guiding holes <NUM> are arranged have the same radius.

However, a radius of a first semi-circular end of the oval path of the pin receiving holes 22a, 22b, <NUM>, which is shown on the right in <FIG>, and along which pin receiving holes 22b are arranged, is larger than a radius of a second semi-circular end of the oval path of the pin receiving holes 22a, 22b, <NUM> shown, which is shown on the left in <FIG>, and along which pin receiving holes 22a are arranged. Hence, the pin receiving holes 22b arranged at the first semi-circular end are located closer to the respectively associated neighboring guiding holes <NUM> than pin receiving holes 22a arranged at the second semi-circular end. More particular, in the embodiment shown, the pin receiving holes 22b arranged at the first semi-circular end partly overlap with the associated neighboring guiding holes <NUM> for forming the common openings and the pin receiving holes 22a arranged at the second semi-circular end are connected to the associated neighboring guiding holes <NUM> via bridges <NUM> for forming the common openings.

In the embodiment shown, the pin receiving holes 22a, 22b and the guiding holes <NUM> in each case have a circular basic shape. Hence, the common openings formed by the receiving holes 22a arranged along the second semi-circular end and the associated neighboring guiding holes <NUM> are dumbbell-shaped. The common openings formed by the receiving holes 22b arranged along the first semi-circular end and the associated neighboring guiding holes <NUM> are figure-of-eight- shaped. Alternative shapes are conceivable to the skilled person.

Claim 1:
A needle holder (<NUM>) for securing a needle in a package for surgical suture material, the needle holder (<NUM>) having a nose (<NUM>) protruding from a base plane, and two arms (<NUM>), which are resiliently deformable and/or displaceable in a plane parallel to the base plane, wherein the arms (<NUM>) are each provided with a stop (<NUM>) for contacting the needle, wherein the stops (<NUM>) are arranged at opposite sides of the nose (<NUM>), wherein a front end of the nose (<NUM>) is serving as a counterbearing for the needle between the two stops (<NUM>), and wherein the arms (<NUM>) are adapted for forcing the needle contacted by the stops (<NUM>) against the front end of the nose (<NUM>), wherein the arms (<NUM>) are L-shaped comprising a pivotally mounted lever (<NUM>) with a first end (<NUM>) serving as a pivot mount, and a second end (<NUM>), wherein in a plane parallel to the base plane the stop (<NUM>) protrudes from the second end (<NUM>) towards the nose (<NUM>), characterized in that
in a neutral initial position the levers (<NUM>) of the arms extend perpendicular to the nose (<NUM>) and the stops (<NUM>) extend parallel to the nose (<NUM>).