Patent Description:
Surgical needles for applying sutures are well known in the art. Known needles comprise an arc-shaped needle connected to a suture thread and having a needle tip at a proximal end of the shaft. While these surgical needles are well suited for closing wounds or fixing adjacent tissues with each other, it is sometimes difficult to connect very small pieces of tissue such as segments of very small vessels or nerves, or tissues of eyes. For example, in adjoining very small diameter vessels with each other there is an inherent risk that by use of a known surgical needle opposite walls of one vessel are sutured with each other which will result in a blocking of the vessel and/or clotting of the blood.

Against this background, it is desirable to simplify the provision of stitches for connecting very small pieces of tissue.

Relevant prior art is disclosed in documents <CIT>, <CIT>, <CIT> and <CIT>.

The invention is defined in appended claim <NUM>.

The frame may be configured to receive the plurality of tissue connector devices in a cantilevered manner. The frame may additionally or alternatively be configured to receive the arc-shaped needles in a way such that the tip of the needles points obliquely or radially towards the principal axis.

The curved frame may comprise a plurality of coupler elements configured to allow for the removable coupling of the tissue connector devices.

The arc-shaped tissue connector devices may actually be mounted on the frame in a detachable manner. For example, a plurality of arc-shaped tissue connector devices may be slidably mounted on the frame in a manner such as to be slidably detachable when sliding the needles in direction of their proximal end. The tissue connector devices or needles may be engaged to the frame at the proximal end of their shaft or at another position between the proximal and the distal end. The connecting point of or bore for connecting the suture may be located between the tip of the needle and the point of engagement to the frame, or may be located beyond the point of engagement to the frame. In the case of a slidable engagement, the needle may be moved in the direction of the tip in a first step and removed from the frame in a second step. The frame may comprise guide for the sliding of the needles which is configured such that during the first step only movement in the direction of the tip is allowed and no tilting or rotation of the needle is permitted. In case the needles are engaged to the frame are described in the foregoing paragraph, this restriction may serve to facilitate a star shaped arrangement of the stitches.

The arc-shaped tissue connector devices may be arranged in a cantilevered manner around the principle axis of the curved frame. They may be substantially equidistantly arranged on the curved frame. The tissue connector devices may be engaged to the frame such that the plane defined by the curvature of each tissue connector device stands in a radial direction. All tissue connector device pairs may be identical.

The curved frame may comprise an annular-shaped body. As such, it may adopt the shape of an optionally closed loop surrounding an opening. The loop does not have to be closed but it is sufficient for the frame to at least partially encompass the opening. The loop may be perfectly circular, but may also be elliptical or more complexly shaped. The longest diameter of the opening may be in the range of between <NUM>,<NUM> and <NUM>, for example, in the range of between <NUM>,<NUM> and <NUM>. The frame may be substantially planar in shape. It may also have a canted inclination with respect to the principle axis. It may be configured such that the distal end of the tissue connector devices extends into an opening or an area in axial alignment therewith and the needle tips are located in the opening or an area in axial alignment therewith.

The frame may comprise a plurality of complementary shaped curved frame members. These frame members may be detachably coupled with each other. The frame members may be substantially semicircularly shaped. They may be of solid makeshift or comprise a wired structure body. In case they comprise a wired structure body, the body may comprise a closed wired loop which delineates an arc-shaped contour. The frame may have a concavely shaped base surface with respect to a principal axial of the curved frame. The concavely shaped base surface may have a curvature which substantially matches a convex curvature of a cornea. The curved frame may be configured to allow for the stowing at least a portion of a suture thread. In the case of a solid body, the frame may comprise curved holes penetrating the body, which serve to slidably engage the arc-shaped tissue connector devices and at the same time serve as a guide. Accordingly, the holes may be arranged such that their curvature is as described for the curvature of the shaft of the arc-shaped tissue connector devices. Frictional engagement may aid to keep the needle in place. The frame may be made from metal such as stainless steel or polymer material for example.

As such, the frame may be divided in two or more frame members, which may be movable relative to each other to allow an opening and closing of the loop. During application of the device, this ability to open and close the loop facilitates placing the frame around the strand-shaped tissue and removing it after stitching.

The device may already be preloaded with the suture thread. The suture thread may in this case comprise a pre-prepared knot. For example, in the case of a solid frame comprising holes, the holes may also comprise a recess, for example a portion of greater diameter, which may accommodate the suture connected to the needle. The recess can be formed, for example, at the proximal end of the hole.

The tissue connector devices may be spot-welded to the curved frame so that they can be broken off from the curved frame. They may be made from a first material different from a second material of the curved frame to which the connector devices are coupled so that connector devices broken off from the curved frame are substantially free from the second material.

The device may further comprise a user-handle. The curved frame may comprise a handle coupler element for allowing the removable coupling of a user-handle. When present, the user-handle may comprise a first and second leg coupled with each other by a scissor mechanism for removably receiving the first and second curved frame member, respectively. The user-handle may serve for manual operation or as a connecting point for machine operation of the device. The support may comprise a pair of levers joined at a fulcrum. In the case of more than one frame members, the close end of each lever may be connected to one of the frame members and the far ends of the levers may serve as a handle or connecting point. The frame may be detachably connected to the support, to allow for a used frame to be replaced by a new one after a stitching procedure has been completed. The connection may be configured such that the frame can be separated from the support by movement in a direction substantially in the direction of the principal axis.

There is further provided for a device comprising two tissue connector devices connected by a common suture thread. The two tissue connector devices may be identical. They may extend in opposite directions.

In one embodiment, the device may comprise a first and a second curved frame arranged in a row with respect to the principle axis. If present, a suture thread may be coiled up in such way as to hold the first and second frame together. The first and second frame may comprise indentations in alignment and extending in the direction of the principle axis, the suture thread being coiled up around the frames in the indentations. The first and second curved frame may be coupled together by the distal ends of the plurality of tissue connector devices.

The device comprises two or more pairs of tissue connector devices. The two tissue connector devices of each pair may extend in essentially opposite directions and be connected by a common suture thread. The two or more pairs of tissue connector devices may be arranged radially around the principal axis. The device may comprise a plurality of pairs of tissue connector devices. All tissue connector device pairs may be identical. All tissue connector devices may extend in a direction in essential alignment with the principal axis. The orientation of the arc-shaped shaft may be such that the principal axis is on the convex side thereof such that the needle tips extend obliquely or radially away from the principal axis. The longitudinal positions of all tissue connector device pairs of the device may be identical. The two tissue connector devices of each pair may be connected by a common suture, for example, at the proximal ends of their shafts. The two tissue connector devices of each pair are coplanar, the plane being defined by the curvature of the shaft. The arrangement of the tissue connector device pairs around the principal axis may be star-shaped, meaning that the planes as defined extend radially from the principal axis. The radial distribution of the tissue connector device pairs around the principal axis may be even.

The first and second curved frames may each have a central opening. One frame may embrace the first tissue connector devices of each pair and the other frame may embrace the second tissue connector devices of each pair. For example, the first and second tissue connector devices of each pair may be embraced at a central section of the shaft thereof. The frames may be perfectly ring-shaped and, for example, form a closed loop. The frames may be configured such that the loop may be opened to remove the frame from the tissue connector devices. For example, the frames may comprise two, for example, half-circle shaped jaws which are connected by a hinge at one end and detachably connected at the other end. The frames may comprise indentations, mounting points or holes to define and freeze an even radial distribution of the tissue connector devices inside the opening. The frames and the tissue connector devices may be slidable with respect to each other in a direction parallel to the principal axis.

A method for communicably coupling a first and a second organ body using a device as described above is also provided. The method comprises embracing, at least partially, the first organ body with the curved frame; and puncturing the first and second organ body and detaching the tissue connector devices from the frame to form the connection between the organ bodies.

A tissue-collar manipulating device may also be provided. It may comprise a longitudinal body with an end for allowing the outward pulling to facilitate creating a flange-type connection between a first and second first organ body. The tissue-collar manipulating device may comprise a support and a disc shaped head having indentations at regular intervals along its circumference. The tissue-collar manipulating device may serve to define and freeze an even radial distribution of tissue connector devices around the principal axis.

A set for suturing human or animal tissue may comprise a tissue-collar manipulating device as described and a device as described. It may serve for connecting two loose ends of a blood vessel.

A tissue connector device may in one embodiment also be provided. It may be used in conjunction with any of the above described embodiments. The tissue connector device may comprise an arc-shaped body having a hook-shaped end which is curved inwardly with respect to the radius of curvature of the arc-shaped body. The hook-shaped end may be tapered. The tissue connector device may comprise at least a portion of a suture thread. The tissue connector device may comprise a first arc-shaped body portion having a first hook-shaped end and a second arc-shaped body portion having a second hook-shaped end.

The tissue connector device comprised in devices according to the claimed invention comprises a shaft having a tip portion which is to a main portion and comprises a tip. The tip is angled in relation to the main portion at an angle of, e.g., smaller <NUM>°. There may be no steady continuation of the shaft as regards the curvature of a main portion of the shaft, but the shaft may be bent backwards, so that the tip extends at an angle in relation to a main portion of the shaft. The longitudinal axis of the tip is angled in relation to a main portion of the shaft. The shaft of the tissue connector device is composed of at least two portions, namely of a main portion which may be held by a surgeon and a tip portion which comprises the tip. The tip, according to embodiments of the invention, is angled in relation to the curvature of the main portion in an angle ranging <NUM>° to <NUM>°. The curvature of the main portion may be substantially constant. The tip portion may be curved or straight. The transition between the main portion and the tip portion of the shaft may be continuous or sudden. The tip may have any shape which is suitable for the purpose of providing a suture. For example the tip may be cone-shaped or may have a number of cutting edges.

The main portion and the tip portion of the shaft may constitute one integral part. Alternatively, the main and the tip portions of the shaft may be manufactured as separate parts which are detachably connected to each other.

The shaft may comprise a bore for attaching a suture thread. The bore may be located at the proximal portion of the shaft. The main portion of the shaft may extend beyond the bore for attaching the suture thread and may serve as a handle or attachment portion for a handle.

The use of a tissue connector device as described above for communicably coupling a first and a second organ body is also provided.

A holder for tissue connector devices may also be provided herein. The holder may be configured such that a plurality of tissue connector device can be arranged on the holder. The holder may have a curved portion. The holder may also comprise another curved portion such that the holder is bifurcated. The holder may also comprise at least a portion of a suture thread.

Further details are hereinafter described with reference to a number of working examples and figures. The figures show:.

According to embodiments, the device schematically shown in <FIG> comprises a curved frame <NUM> operative to receive a plurality of tissue connector devices in the form of surgical needles <NUM>. The frame is connectable to a user-handle <NUM> for manual operation. The frame comprises an annular-shaped body and defines an opening <NUM> which encompasses a blood vessel <NUM> to be sutured.

The frame <NUM> may be constituted by an annular ring. It may be constituted by two complementary shaped curved frame members <NUM> and <NUM>, which are identical and adopt the shape of a half ring, together forming a closed loop. The both frame members <NUM> and <NUM> are solid bodies and comprise curved holes <NUM> which serve to engage the needles <NUM>, as described hereinafter.

In some embodiments, each frame member may be individually mounted to user-handle <NUM> and movable relative to each other to allow an opening and closing of the ring. The user-handle <NUM> comprises a pair of levers <NUM> joined at a fulcrum <NUM>, the proximal end <NUM> of each lever being connected to one of the frame members and the distal ends <NUM> of the levers with respect to the frame members serving as the handle. As apparent particularly from <FIG>, the frame members <NUM> and <NUM> may be detachably connected to the user-handle <NUM> via a plug-in connection, comprising for example a plurality of pins <NUM> and corresponding recesses <NUM>. This allows for used frame members, which are devoid of needles, to be replaced by new frame members to continue stitching using the same user-handle after one procedure has been completed. The pins and recesses extend in the direction of the principal axis z such that the frame members can be separated from the support by movement in the direction of the principal axis. Both the frame and the user-handle may be made from stainless steel for example or of any other suitable material.

In some embodiments, the needles <NUM> are for example evenly distributed over the circumference of the opening. They extend, when coupled to the frame(s), into the opening <NUM> and an area <NUM> in axial alignment with the opening <NUM>, the needle tips <NUM> being located within the area <NUM>. The plane Z defined by the curvature of each needle is spanned by the vector in direction of the principal axis z and a radial vector in the XY plane defined by the frame. In some embodiments, the proximal end <NUM> of the arc-shaped shaft <NUM> of a needle is detachably engaged a frame member at. One or more needles (e.g., three needles) may be detachably engaged with at least one of the frame members.

In some embodiments, the distal end of the needle's shaft is provided with the needle tip. A suture thread <NUM> is connected to the proximal end of the shaft. In some embodiments, the shaft may comprise a non-uniform curvature. The curvature of the distal end section may for example be significantly higher than the curvature of the central section.

The detachable engagement of the needles <NUM> to the frame <NUM> is best apparent from <FIG>. In some embodiments, the solid body of the frame <NUM> comprises curved holes <NUM> in which the proximal section of the curved shaft <NUM> of the needles <NUM> is slidably engaged, e.g., in a frictional manner. Additional or alternative coupling mechanism may be employed. In some embodiments, the holes <NUM> fully traverse the body of the frame. In some other embodiments, the holes <NUM> only partially traverse the body the frame. At the back end the holes <NUM> comprise in some embodiments a portion <NUM> of greater diameter to accommodate the suture thread <NUM> of the needle.

Upon application of the device, the surgeon holds in some embodiments on to the user-handle <NUM> and moves the frame <NUM> to one segment <NUM> of the desired vessel <NUM> to be stitched. The user-handle is operated to separate the two frame members <NUM> and <NUM> and open the ring, such that the vessel can be placed inside the opening <NUM>. The user-handle is then operated to close the ring. Depending on the dimensions and on how close the needle tips are to the center C of the opening, the needles <NUM> already puncture the vessel segment <NUM>. In case the vessel segment is not already punctured, the needles <NUM> are slid out of the holes <NUM> (e.g., pulled or pushed using suitable tools) until all needles puncture the vessel segment <NUM>. Care should be taken that the vessel is punctured close to the loose end to be connected. As the proximal section of the needle shaft is still inside the hole <NUM>, no tilting or rotation of the needle is permitted, which allows for an even puncturing of the vessel. The vessel segment <NUM> is then firmly held in place without the need for additional tools. Vessel segment <NUM> is then brought in alignment with vessel segment <NUM>, which is held in place by, for example, a clamp or the like. The needles <NUM> are then, one by one, slid out of the holes <NUM> completely to complete the stitches. The curvature and mounting position of the needles is such that the orientation of the distal portion of the needle shaft becomes more axial with increasing proximity to the tip, such that the tips already point in the correct direction before this working step is initiated. In the first part of that movement, when the at least some of the proximal section of the needle shaft is still inside the hole <NUM>, no tilting or rotation of the needle is permitted, which supports correct movement and aids not to puncture the opposite end of the vessel. It is apparent that the needles are configured and engaged to the frame such that the needle tips may approximate the center C of the opening very closely, e.g., by less than a millimeter, but not reach or cross it. During the second part of that movement, the needle is then freely moved and tilted to complete the stitch. Tissue-collar manipulating device <NUM> may be used as a further support. Lastly, the user-handle is again operated to separate the two frame members <NUM> and <NUM> and open the ring, such that the device can be removed from the stitched vessel <NUM>.

The fact that all needles and the vessel are firmly held in place for each of the stitches, and the fact that the movement of the needles is, at least partially guided, allows for a more precise outcome of the procedure.

In the further embodiments according to <FIG>, only differences to the embodiment of <FIG> will be discussed. Reference numerals are designated as in <FIG>.

<FIG> and <FIG> show an embodiment, wherein the holes <NUM> in the frame <NUM> run substantially in the direction of the principal axis and wherein the needles <NUM> are longer and have a curvature covering more than <NUM>° for example. The curvature is substantially uniform over the whole length of the needle shaft <NUM>. A suture thread <NUM> is connected to the shaft between its engagement point with the frame and its distal end. This allows for an even more precise operation as the movement of the needles is also guided when they exit the second vessel <NUM>. However, it may not be possible to puncture the first vessel already upon closing the frame <NUM>, but it may be necessary to slide the needles before the first vessel <NUM> is fixed.

<FIG> shows an embodiment where the frame in this embodiment does not comprise solid bodies but is a wired structure body <NUM> to which the needles <NUM> are engaged. The needles are detachably engaged to a needle stub <NUM> which resembles a continuance of the needle shaft. The connection <NUM> between the needle stub <NUM> and the needle <NUM> is a mechanical connection. The suture thread <NUM> is connected to the needle at the proximal end. Once the device is applied to the vessel, and the needles have punctured the vessel upon closing of the frame, the needles <NUM> are disengaged from the stub and the stitches completed one by one.

The embodiments shown in <FIG> are, for example, suited for connecting two loose ends of a strand-shaped piece of tissue such as a blood vessel. During such application, the device is arranged such that the segments <NUM> pass the opening <NUM> in direction Z of the principal axis and are encompassed by the frame <NUM>. Suturing blood vessels has been selected as a representative embodiment and the same procedure as described above may be conducted using nerves and the like.

In this embodiment of <FIG> the needles <NUM> are shorter than the needles of the previous embodiments and, optionally, hook-shaped. The frame is equipped with hollow needle stubs <NUM> which are tubes curved in a manner as described for the needle shafts in the embodiment of <FIG>. The short needles are slidably engaged inside the needle stubs , with the suture thread <NUM> being connected to the proximal end of the needles. Due to the configuration of the needle stubs and the needles, the embodiment shown in <FIG> is, for example, suited for connecting for connecting a loose end of a strand-shaped piece to a hole in a continuous strand-shaped piece of tissue <NUM> such as a blood vessel (e.g., <NUM>-way connection). During such application, the device is arranged such that the loose segment <NUM> passes the opening <NUM> in a direction Z of the principal axis and is encompassed by the frame <NUM>. Suturing blood vessels has been selected as a representative embodiment and the same procedure as described above may be conducted using nerves and the like.

<FIG> and <FIG> show a further embodiment suitable for forming three-way connections for example, optionally for obliquely connecting a loose end of a strand-shaped piece to a hole in a continuous strand-shaped piece of tissue. One significant difference over the embodiment discussed before is the non-circular and not fully planar shape of the frame <NUM>, which serves to avoid spatial obstruction when obliquely connecting a loose end of a strand-shaped piece to a hole in a continuous strand-shaped piece of tissue. The engagement of the needles to the frame is as discussed in connection with <FIG>.

<FIG> show an embodiment suitable for connecting patch-shaped tissue, for example, the cornea to the sclera.

In one embodiment, the needles are engaged to the frame such that they axially or obliquely extend from the frame and the needle tips are located beyond the plane defined by the frame. This embodiment of the device is, for example, suited for connecting patch-shaped tissue, for example, the cornea to the sclera. The frame may adopt any shape corresponding to the shape of the tissue patches which are intended to be sutured. A loop surrounding an opening may be employed also in this embodiment as it allows to access the needles and to have an unobstructed view from two sides. In this embodiment, the frame may be formed as one integral part, as after stitching no removal of the device from a strand-shaped tissue sitting in the opening is required.

The frame <NUM> is formed as one single piece and the user-handle <NUM> is a simple rod. The frame is substantially circular with each of its walls slightly tilted in order to resemble shape of the eyeball. The needles, contrary to the foregoing embodiments, not extend into the opening, but obliquely extend from the frame such that the needle tips are located beyond the plane defined by the frame. The needles have a constant curvature and the curvature extends over, e.g., more than <NUM>°.

Upon application of the device according to <FIG>, the surgeon holds on to the user-handle <NUM> and moves the frame <NUM> to axially approach and contact the eyeball <NUM> such that the central opening <NUM> is in alignment with the cornea <NUM> to be attached. During the approach, the needles <NUM> already puncture the cornea. The cornea is then firmly held in place without the need for additional tools. The needles <NUM> are then, one by one, slid out of the holes <NUM> completely to complete the stitches. In the first part of that movement, when the at least some of the proximal section of the needle shaft is still inside the hole <NUM>, no tilting or rotation of the needle is permitted, which supports correct movement.

The device shown in <FIG> is generally designated with numeral <NUM> and comprises a plurality of pairs <NUM> of identical needles <NUM>. In some embodiments, the two needles of each pair are connected by a common suture thread <NUM> at the proximal ends <NUM> of their shafts. The needles <NUM> comprise a curved shaft where the distal end is provided with a needle tip. The suture thread <NUM> is permanently connected to the shaft at the proximal end <NUM> thereof. The shaft comprises a non-uniform curvature for example, wherein the angle between the orientation of the tip <NUM> and the orientation of a central section <NUM> of the shaft ranges, for example, from <NUM>° to <NUM>°. The curvature of the central section is substantially constant and the curvature of the distal section <NUM> adjacent to the tip is higher than the curvature of the central section. The needle may be integrally formed as a one-piece needle body from stainless steel for example or any other suitable material. The two or more pairs of needles are arranged radially around a common longitudinal axis A.

In some embodiments, the two needles belonging to each pair extend in opposite directions meaning that the directions N of the needles confine an angle of, e.g., <NUM>° or more (the 'direction of a needle' being understood as the imaginary line from the proximal to the distal end of the needle). All needles extend essentially in the direction of the principal axis such that the offset between the direction N of the needles and the direction of the principal axis A is less than, e.g., <NUM>°. The longitudinal positions d of all needle pairs of the device are identical. For example, the longitudinal positions of the first needles 103a of each pair and the longitudinal positions d of the second needles 103b of each pair are identical.

The orientation of the needles <NUM> is such that the longitudinal axis A is on the convex side of the needles. The two needles <NUM> of each pair <NUM> are coplanar. The arrangement of the needle pairs <NUM> around the longitudinal axis A is star-shaped, the radial distribution of the needle pairs <NUM> around the longitudinal axis being substantially even.

The device <NUM> further comprises two frames <NUM> having a central opening <NUM>, one frame embracing the first needles 103a of each pair and the other frame embracing the second needles 103b of each pair. The first and second needles of each pair are embraced at the central sections <NUM> of their shafts. The frames <NUM> are ring-shaped and form a closed loop. They comprise two half-circle shaped frame members <NUM> and <NUM> which are connected by a hinge at one end <NUM> and detachably connected at the other end <NUM>. The frames <NUM> and the needles <NUM> may be slidable with respect to each other in the longitudinal direction.

There is further provided for a tissue-collar manipulating device <NUM>, the tissue-collar manipulating device comprising a support <NUM> and a disc shaped head <NUM> having indentations <NUM> at regular intervals along its circumference. The tissue-collar manipulating device serves to define and freeze an even radial distribution of the needles inside the opening.

The device allows for a plurality of sutures to be regularly, precisely and quickly distributed over the circumference of two separate pieces of hollow, strand-shaped tissue having small diameter, such as a blood vessels, to connect the pieces. It is suitable for use in microsurgery and automated surgery.

Upon application of the device, in a first step as shown in <FIG>, the surgeon axially aligns the device with two separate loose ends <NUM> and <NUM> of a blood vessel to be connected. The device is in its ground state having one frame <NUM> attached to the first needles 103a of each pair of needles and the other frame <NUM> embracing the second needles 103b of each pair needles. The needle pairs are evenly distributed. One tip end of the device is then inserted into the hollow interior of the loose end of at least one blood vessel.

Once the tip end of the device is inside the hollow interior of the loose end of the vessel, the head <NUM> of the tissue-collar manipulating device <NUM> is inserted into the space between the respective needles <NUM> of each pair and operated to maintain an even distribution of the needles. This is shown in <FIG>. The respective needles <NUM> are then slid relative to the frame ring <NUM> in a direction towards the vessel, the needle tips thereby progressing further away from the longitudinal axis and puncturing the wall of the blood vessel <NUM> from the inside. The needles may be slid relative to the frame ring all at once or one by one. The tissue-collar manipulating device <NUM> may also be operated to evenly distribute the needles before the tip end of the device is inserted into the blood vessel. Also, both tip ends of the device may be inserted to both loose ends of the vessel before the needles are evenly distributed and/or before the needles may be slid relative to the frame ring.

As shown in <FIG> and <FIG>, the frame <NUM> is then removed from the device before the stitches are formed in a well-known way upon completing movement of both the needles through the wall of the vessel and knotting together the ends of the suture connecting the two needles of a pair. As shown in <FIG>, the tissue-collar manipulating device <NUM> may be held in place for some time to guide the movement of the needles.

The fact that all needles and the vessel are held in place relative to each other during the formation of each of the stitches allows for a more precise outcome of the procedure.

The device shown in <FIG> is also generally designated with numeral <NUM> and comprises a plurality of pairs of identical needles <NUM>. Identical entities to the device of <FIG> are labelled with the same reference signs and only differences to the device shown in <FIG> will be discussed in the following.

The frame members <NUM> of the bracket are configured as two separate rings <NUM> and <NUM> which are spaced apart from one another in longitudinal direction. All rings are arranged about the common longitudinal axis Z and are essentially identical. The two rings <NUM> and <NUM> of the frame member may be connected to one another but may alternatively only be associated by way of the needles.

The frame members <NUM>, specifically the proximal rings <NUM> thereof, are connected to one another by means of the connecting stick <NUM>, which extends in the direction of the longitudinal axis Z. The connecting stick may be formed two separate pieces <NUM> and <NUM>, which are releasably connected at an interface <NUM>, for example, by mechanical fastening. Both pieces <NUM> and <NUM> may be identical and the connecting stick <NUM> is circular in diameter. The connecting stick <NUM> sets a configuration of the device <NUM> where the frame members <NUM> and all rings <NUM> and <NUM> thereof are arranged symmetrically about the common longitudinal axis Z. The connecting stick is not connected to either of the needles or the sutures.

The device further comprises two positioning sticks <NUM> and <NUM> which are arranged in the common longitudinal axis Z. The distal end <NUM> of the first positioning stick <NUM> longitudinally projects beyond the tips <NUM> of the first needles 103a and the distal end <NUM> of a second positioning stick <NUM> longitudinally projects beyond the tips <NUM> of the second needles 103b.

The positioning sticks <NUM> and <NUM> have a circular cross-section corresponding to the circular shape of the interior of the vessel to be sutured. The distal ends <NUM> and <NUM> of the positioning sticks <NUM> and <NUM> are tapered for easier insertion to the interior of the loose ends <NUM> and <NUM> of the vessel.

The positioning sticks <NUM> and <NUM> are mounted to the frame members <NUM>, specifically to the distal rings <NUM> thereof, at their proximal ends <NUM> and <NUM>. At the proximal ends <NUM> and <NUM> of the positioning sticks, the positioning sticks or the distal rings <NUM> of the frame members <NUM> or the proximal ends <NUM> or <NUM> of the positioning sticks <NUM> or <NUM> may comprise an annular chamfer 152a and 162a, which, upon inserting the distal ends <NUM> and <NUM> of the positioning sticks <NUM> and <NUM> into the vessels <NUM> and <NUM>, facilitates the formation of a flange 131a and 132a at the vessel wall in immediate proximity to its loose end. The needles <NUM> are, for example, contained in the device <NUM> such that the needle tips <NUM>, upon moving the needles <NUM> in a distal position, exit the distal rings where the annular chamfer 152a or 162a, respectively, is located and are guided to pass the annular chamfer 152a or 162a, respectively. This way, the needles can pierce the vessel wall at the flange 131a or 132a, respectively, close to its loose end, which supports the formation of a clean stitch.

When using the device <NUM> of this embodiment, the distal end <NUM> of the first positioning stick <NUM> is inserted to the interior of one loose end <NUM> of the vessel to be sutured, and the distal end <NUM> of the first positioning stick <NUM> is inserted to the interior of the other loose end <NUM> of the vessel to be sutured. By inserting the distal ends <NUM> and <NUM> of the positioning sticks <NUM> and <NUM> into the vessels, a correct positioning of the device <NUM> and thus of the needles <NUM> relative to the loose ends <NUM> and <NUM> of the vessel can be facilitated before the suturing is started.

The process is the continued in a manner as described in connection with <FIG>. Different stages are shown in <FIG>. Like the frame rings also the positioning sticks <NUM> and <NUM> are removed from the device at the end of the procedure and before the stitches are finalized. In this regard, the frame rings may be opened and the two separate pieces <NUM> and <NUM> of the connecting stick <NUM> may be separated at the interface <NUM>. Each half of the device including one piece of the connecting stick, one pair of frame rings and one positioning stick is then moved backwards in an axial direction (illustrated by arrow A in <FIG>) to pull the positioning stick out of the vessel and subsequently removed from the vessel ends and the incomplete sutures. Finally, the stitches are formed.

<FIG> shows another embodiment of a device according to the invention. Identical entities to the device of <FIG> are labelled with the same reference signs and only differences to the device shown in <FIG> are now discussed. Specifically, the device shown in <FIG> differs over the device shown in <FIG> in that the two pieces <NUM> and <NUM> are not engaged to one another to form a connecting stick, but are separate from one another during application. This way, a proper fitting of each half of the device can be made to each of the loose ends of the vessel, regardless of the relative position of the two loose ends. Upon application, once the distal ends <NUM> and <NUM> of the positioning sticks <NUM> and <NUM> of this embodiment have been inserted to the vessel ends, the two pieces <NUM> and <NUM> may be connected to form a connecting stick and result in the embodiment of <FIG>.

Referring to <FIG>, the tissue connector device <NUM> is in the form of a surgical needle comprising an arc-shaped main portion <NUM> of the shaft. One end portion of the main portion <NUM> is provided with a bore <NUM> for attaching a suture thread <NUM>, which is made of a material which is physiologically compatible. The material of the suture thread <NUM> may be absorbable by the body of the patient.

The bore <NUM> are provided with a hole <NUM> in the main portion <NUM> of the shaft. In order to fix the suture thread to the main portion <NUM> of the shaft, the bore <NUM> may be closed about the suture end by swaging, squeezing or any other process which is suitable to fix the suture thread <NUM> with the main portion <NUM> of the shaft.

The other end of the main portion <NUM> of the shaft is connected with the tip portion <NUM> of the shaft, which is arc-shaped as well. The radius of the curvature of the tip portion <NUM> of the shaft is smaller than that of the curvature of the main portion <NUM> of the shaft. The tip portion <NUM> of the shaft and the main portion <NUM> of the shaft are portions of a one-piece metal part. For example, shaft may be made of stainless steel or any other suitable material.

The tip portion <NUM> of the shaft comprises the tip <NUM> of the needle <NUM>. The distal end of the tip portion <NUM> of the shaft (which is not adjacent the main portion <NUM> of the shaft) is formed by the tip <NUM> of the needle <NUM>.

As shown in <FIG>, the angle between the tip <NUM>, i.e. between the direction into which the tip is directed (or the longitudinal axis of the tip <NUM>) and the longitudinal axis of part <NUM>' of the main portion <NUM> of the shaft which is adjacent to the tip portion <NUM> of the shaft is denominated with α. The angle α may be in the range of, e.g., approximately <NUM>° to <NUM>°. Accordingly, the tip <NUM> of the needle is not directed along the longitudinal axis L of the portion <NUM>' of main portion <NUM> of the shaft which is adjacent the tip portion <NUM> of the shaft but bent backwards as shown in <FIG>. Thus the tip <NUM> of the needle <NUM> is directed backwards with respect to the main portion <NUM> of the shaft of the needle <NUM>. The leading edge <NUM> of the needle <NUM> is not necessarily an acute tip, but a rounded portion.

In order to puncture the needle <NUM> into the tissue the needle is inserted into the vessel, nerve etc. and then moved backwards so that the tip penetrates the wall of the vessel or nerve. Thereafter the surgeon pulls or pushes the needle through the penetration together with the suture thread <NUM> in order to suture the open ends of the vessels etc. with each other.

<FIG> shows an embodiment which is identical to the embodiment of <FIG> except the grip portion <NUM>. This portion extends beyond the bore for fixing the suture and serves as a grip or for mounting a grip for a better handling of the needle.

The embodiment of <FIG> is directed to a system of two needles <NUM> which are linked to each other by a common suture thread <NUM>. The needles <NUM> are identical and each correspond to the needle which is shown in <FIG>. The embodiment of <FIG> shows a system of two needles <NUM> which are linked to each other by a common suture thread <NUM> as well as by a linking portion <NUM>. The portion <NUM> may be removed from the needles <NUM> by braking. In <FIG> the two needles <NUM> are located opposite of the linking portion <NUM> and are arranged symmetrically in relation to the linking portion <NUM>. The system of <FIG> or <FIG> may be used by the surgeon by inserting each of the two needles <NUM> into an open end portion of a vessel or the like. Thereafter the tips <NUM> of the needles <NUM> penetrate the respective walls of the vessels or the sheaths of nerves etc., the needles are pulled or pushed through the penetrations, the suture is cut off the needles and the ends of the suture are connected with each other.

To summarize, the device as presented herein may allow for a plurality of sutures to be regularly, precisely and quickly applied to a very small piece of tissue such as small nerves, vessels or a cornea. It may also aid to hold the tissue in place and may be used without separate clamps to hold the tissue in place.

In one embodiment, the device may allow for a plurality of sutures to be regularly, precisely and quickly distributed over the circumference of two separate pieces of hollow, strand-shaped tissue having small diameter, such as a blood vessels, to connect the pieces.

The device may be suitable for use in microsurgery and automated surgery.

Aided by an angled orientation of the tip in relation to the curvature of the main shaft, in one embodiment, the tip of the tissue connector device may be inserted into the vessel or under the sheath of a nerve and can be punctured through the wall of the vessel or through said sheath of a nerve by a backward movement with relation to the direction of the insertion of the needle so that the tip penetrates the wall or the sheath. The angled orientation of the tip may allow to reliably suturing vessels or nerves having very small inner diameters with each other while minimizing the risk that opposite walls are sutured to each other. The tissue connector device may allow a manual as well as an automated preparation of a suture.

In the discussion, unless otherwise stated, adjectives such as "substantially" and "about" that modify a condition or relationship characteristic of a feature or features of an embodiment of the invention, are to be understood to mean that the condition or characteristic is defined to within tolerances that are acceptable for operation of the embodiment for an application for which it is intended.

Claim 1:
A surgical device (<NUM>) for suturing human or animal tissue, in particular for connecting two loose ends of a blood vessel or two loose ends of a nerve strand, which comprises two or more pairs of surgical needles (<NUM>) comprising a curved main shaft (<NUM>) provided with a needle tip (<NUM>) at its distal end, the two needles of each pair extending in essentially opposite directions and being connected by a common suture, and the two or more pairs of needles being arranged radially around a common longitudinal axis, each of the needles comprises a needle body that includes a curved main shaft connected with the suture, wherein the needle body further comprises a tip shaft which is connected with the main shaft and which comprises the needle tip, the needle tip being angled in relation to the portion of the main shaft which is adjacent to the tip shaft, wherein the angle between the needle tip and said portion of the main shaft is between <NUM>° and <NUM>°.