Needle-suture assembly, needle holder and surgical suturing device

Abstract

The present invention relates to a needle-suture assembly, a needle holder and a surgical suturing device, wherein the needle-suture assembly comprises: a needle having a first needle end and a second needle end opposite to the first needle end; and a suture connected to the needle and located between the first needle end and the second needle end, wherein each of the first needle end and the second needle end comprises a needle tip and a locking groove for receiving a locking element of the needle holder, and is characterized in that the first needle end and the second needle end both comprise a needle end stop surface between the groove and the needle tip, wherein the needle end stop surface is arranged to cooperate with a needle channel stop surface of the needle channel of the needle holder.

Description

[0001] The present invention relates to a needle-suture assembly, a needle holder cooperating with such a needle-suture assembly, and a surgical suturing device incorporating the needle holder.

[0002] Surgical stapling devices for passing a double-ended surgical needle of a needle-suture assembly forward and backward are known from the prior art.

[0003] An example of such a surgical device is known from WO 2017 / 155406, the entire contents of which are incorporated herein by reference.

[0004] The known surgical device comprises a first jaw element and a second jaw element. The first jaw element comprises a first needle holder to hold a first needle end of a surgical needle-suture assembly, and the second jaw element comprises a second needle holder to hold a second needle end of the surgical needle-suture assembly.

[0005] An operating device is provided to operate the first needle holder and the second needle holder to alternately hold the first needle end by the first needle holder and hold the second needle end by the second needle holder.

[0006] The first jaw element and the second jaw element are movable relative to each other between a take-over position, in which a surgical needle can be passed between the first needle holder and the second needle holder, and an open position, in which the first needle holder and the second needle holder are spaced farther apart from each other.

[0007] In the surgical device of WO 2017 / 155406, the first jaw element and the second jaw element are moved toward each other from the take-over position to activate the operating device. This activation movement of the first jaw element and the second jaw element from the take-over position toward each other occurs in particular at the following parts of the first jaw element and the second jaw element: at the parts, operating surfaces or operating elements are provided to apply a pinching force on the first jaw element and the second jaw element. These operating surfaces or operating elements are, for example, arranged in the middle part of the first jaw element and the second jaw element, that is, respectively, arranged between the distal end and the proximal end of the first jaw element and the second jaw element.

[0008] In order to allow this enabling movement, the first jaw element and / or the second jaw element may be bendable. As an alternative, the first jaw element and / or the second jaw element may be provided with a rotation point within the respective jaw element for rotating the first jaw part relative to the second jaw part. By this bending or internal rotation of the first jaw element and / or the second jaw element, the first jaw element and the second jaw element can be moved towards each other in their middle parts, while the proximal ends and the distal ends of the first jaw element and the second jaw element remain substantially in the same position.

[0009] At the beginning of the activation movement, the first jaw element and the second jaw element are in a take-over position in which the needle end of the needle-suture assembly has been placed in the first needle holder and the second needle holder. Therefore, the first jaw element and the second jaw element are configured to rotate around the respective needle tip of the needle end arranged in the first needle holder and the second needle holder during the activation movement of the first jaw element and the second jaw element.

[0010] A disadvantage of this configuration of the surgical stapling device, and in particular the activation movement of the first and second jaw elements, is that rotation of the first and second jaw elements about the respective needle tips of the needle end may have a negative impact on the shape and / or condition of the needle end.

[0011] The object of the present invention is to provide a needle-suture assembly and / or a needle holder that facilitates the use of a needle-suture assembly in a surgical suturing device of the type described above. In general, the object of the present invention is to provide an improved needle-suture assembly and / or a needle holder for a surgical suturing device, in particular for a surgical suturing device as disclosed in WO 2017 / 155406.

[0012] The present invention provides a needle-suture assembly.

[0013] The needle-suture assembly comprises a needle and a suture connected to the needle. The suture is connected to the needle between a first needle end and a second needle end. The needle has a first needle end and a second needle end opposite to the first needle end. Each of the first needle end and the second needle end comprises a needle tip and a locking groove for receiving a locking element of a needle holder.

[0014] According to the present invention, the first needle end and the second needle end each include a needle end stop surface between the locking groove and the needle tip, wherein the needle end stop surface is arranged to cooperate with a needle channel stop surface of the needle channel of the needle holder. By providing a specific needle end stop surface on the needle that is separate from the needle tip and is used to cooperate with the needle channel stop surface of the needle holder, the contact between the needle end stop surface and the needle channel stop surface can be optimized for the rotation of the first and second clamp elements around the respective needle ends. In addition, the needle tip itself does not have to come into contact with the needle channel, thereby avoiding damage to the needle tip.

[0015] The needle end stop surface may be optimized for rotation of the needle end stop surface relative to the needle channel stop surface. For example, the shape of the needle end stop surface may be modified for this reason, for example the needle end stop surface may be hardened.

[0016] The needle end stop surface may be coated with, for example, a lubricious coating that facilitates movement of the needle end stop surface over the needle channel stop surface or a wear resistant coating that reduces wear of the needle end stop surface.

[0017] Since the needle end stop surface is arranged to provide contact between the needle and the needle channel to facilitate rotation of the first and second jaw elements about the respective needle ends, the needle tip is no longer required to provide engagement between the needle and the needle channel. As a result, the needle tip of each of the first and second needle ends can be optimized for piercing tissue.

[0018] In one embodiment, each needle tip includes a tip surface extending at a first acute angle relative to the longitudinal axis of the needle, wherein each needle end stop surface extends at a second acute angle relative to the longitudinal axis of the needle, and wherein the first acute angle is greater than the second acute angle.

[0019] The tip surface is the one or more surfaces that define the tip of the needle.

[0020] It has been found that for the rotation of the first and second jaw elements about the needle end, it is advantageous if the needle end stop surface is more parallel to the longitudinal axis of the needle than the tip surface of the needle tip. Since the needle end stop surface is separate from the needle tip, the angle of the needle end stop surface can be made more parallel to the longitudinal axis of the needle, while the angle of the tip surface of the needle can be set at a greater angle relative to the longitudinal axis of the needle.

[0021] In an embodiment, the needle tip surface may be arranged at a first acute angle in the range of 15 to 40 degrees relative to the longitudinal axis of the needle, such as in the range of 20 to 30 degrees relative to the longitudinal axis of the needle.

[0022] In an embodiment, the needle end stop surface may be arranged at a second acute angle in the range of 5 to 20 degrees relative to the longitudinal axis of the needle, such as in the range of 8 to 15 degrees relative to the longitudinal axis of the needle.

[0023] In one embodiment, the tip surface of the needle tip is at least partially conical. The tip surface of the needle tip of each needle end may have a substantially conical shape ending in a sharp point. The tip surface may also have any other suitable shape, such as three facets ending in a sharp point.

[0024] In one embodiment, the needle end stop surface is at least partially conical. The needle end stop surface of each needle end can be substantially conical. It has been found that the conical surface is suitable as a rotational surface for the first clamp element and the second clamp element. In addition, the conical shape of the needle end stop surface allows the needle to be placed in any rotational position in the needle channel while maintaining proper engagement between the needle end stop surface and the needle channel stop surface. The needle end stop surface can also have any other suitable shape, such as a spherical shape. Generally, the needle end stop surface will have a surface that is at a non-zero angle relative to the longitudinal axis of the needle. The needle end stop surface can be symmetrical relative to the longitudinal axis of the needle.

[0025] In one embodiment, the substantially conical needle end stop surface is slightly convex. Slightly convex means that the main shape of the needle end stop surface is substantially conical, but within this main conical shape, the surface is convex. Such a convex shape can improve the rotation of the first jaw element and the second jaw element around the needle end of the needle.

[0026] In one embodiment, the needle is a straight needle. An advantage of a straight needle, especially when the needle has a small diameter, is that the needle is better suited to withstand the longitudinal compression forces generated by pushing the first and second jaw elements toward each other on the needle end. In addition, a straight needle can be arranged in the needle channel regardless of its rotational position.

[0027] In one embodiment, the locking groove extends around the entire periphery of the needle. By providing a straight needle and a circumferential locking groove, the needle can be properly arranged in the needle channel of the surgical suturing device regardless of the rotational position of the needle. This is advantageous because it is no longer necessary to align the rotational position of the needle relative to the needle channel before loading the needle into the needle holder. When the needle is to be reloaded, for example, after being temporarily released from the needle holder, the difficulty of reloading the needle into the needle holder is less because the user does not need to modify the rotational position of the needle in order to reload the needle into the needle holder.

[0028] Another advantage of the rotational position independence of the needle is that the needle will be arranged in different rotational positions in the needle holder, which reduces wear at specific positions.

[0029] The present invention also provides a needle holder for holding a needle-suture assembly, wherein the needle holder comprises:

[0030] a needle channel arranged to receive the first needle end or the second needle end, the needle channel comprising an inlet to introduce the respective needle end into the needle channel, and

[0031] a needle locking element for locking the respective needle end in the needle channel,

[0032] Therein, the needle channel includes a needle channel stop surface to cooperate with the needle end stop surface of the needle-suture assembly.

[0033] The needle-suture assembly of the present invention can be advantageously used in a needle holder, in particular in a needle holder having a needle channel provided with a needle channel stop surface designed to cooperate with a corresponding stop surface of a needle end. The needle end stop surface and the needle channel stop surface can be substantially matching surfaces.

[0034] The needle end stop surface and the needle channel stop surface cooperate with each other to form a support structure that allows the needle channel stop surface to move relative to the needle end stop surface to facilitate rotational movement of the first and second jaw elements of the surgical suturing device around the corresponding needle ends of the needle-suture assembly.

[0035] The needle channel stop surface can be optimized for this rotational movement. For example, the shape of the needle channel stop surface can be modified, for example the needle channel stop surface can be hardened.

[0036] The needle passage stop surface may be coated with, for example, a lubricious coating that facilitates movement of the needle end stop surface over the needle passage stop surface or a wear resistant coating that reduces wear of the needle passage stop surface.

[0037] The locking element is movable between a locking position and an unlocking position. In the locking position, the locking element will extend into the locking groove of the needle end of the needle introduced into the needle channel, and in the unlocking position, the locking element will be moved out of the needle channel so that the needle is free to move into and out of the needle channel.

[0038] In case the needle comprises a circumferential locking groove, the locking element may be moved in a direction which is radial with respect to the longitudinal axis of the needle channel and thus with respect to the longitudinal axis of the needle arranged in the needle channel.

[0039] In one embodiment, the needle channel stop surface is substantially conical. The angle of the needle channel stop surface may substantially correspond to the angle of the needle end stop surface, so that there is a contact plane rather than a contact line between the needle end stop surface and the needle channel stop surface of the needle channel. In another embodiment, the needle channel contact surface may have any other suitable shape, such as a spherical shape to facilitate rotation of the forceps element around the needle end.

[0040] In one embodiment, the substantially conical needle channel stop surface is slightly concave. Slightly concave means that the main shape of the needle channel stop surface is substantially conical, but within this main conical shape, the surface is concave. Such a concave shape can improve the rotation of the first jaw element and the second jaw element around the needle end of the needle.

[0041] In one embodiment, the needle channel is configured to not contact the needle tip when the needle channel stop surface engages the needle end stop surface. Since the needle end stop surface and the needle channel stop surface are arranged to provide a contact plane between the needle and the needle holder, the needle tip no longer has to be in direct contact with the needle channel surface when the needle is arranged in the needle channel. This means that the needle tip will not be damaged by contact between the needle channel and the needle when the needle is arranged in the needle channel.

[0042] In one embodiment, the needle channel comprises an alignment funnel-shaped socket at the entrance to align the needle end with the needle channel. In order to allow the forceps element to rotate relative to the needle end, some play of the longitudinal axis of the needle relative to the longitudinal axis of the needle channel must be provided. As a result, the needle may not always be completely aligned with the needle channel when the first forceps element and the second forceps element are moved from the open position to the take-over position, in which only one needle end is arranged in the needle channel of the corresponding needle holder, and in the take-over position, both needle ends are arranged in the needle holder. In order to ensure that the needle end is properly introduced into the needle channel, an alignment funnel-shaped socket may be provided at the entrance of the needle channel. The alignment funnel-shaped socket is arranged to receive the needle end and guide the needle end toward the needle channel while aligning the longitudinal axis of the needle with the longitudinal axis of the needle channel. The alignment funnel-shaped socket will generally have a funnel-shaped surface that narrows toward the needle channel, such as a substantially conical surface. The wide end of the alignment funnel-shaped socket may have a cross-section having a diameter that is at least twice the diameter of the needle, such as at least three times the diameter of the needle.

[0043] It should be noted that the alignment funnel-shaped socket can be used for the alignment of the needle of any surgical needle-suture assembly. Therefore, a needle holder is also provided to hold the surgical needle-suture assembly, wherein the needle holder includes a needle channel, which is arranged to receive the needle end of the needle of the needle-suture assembly, and the needle channel includes an entrance to introduce the corresponding needle end into the needle channel, wherein the needle channel includes an alignment funnel-shaped socket at the entrance to align the needle end with the needle channel. Such a needle holder can be provided in a surgical suturing device for passing a double-ended surgical needle-suture assembly forward and backward, wherein the surgical device includes:

[0044] a first jaw element and a second jaw element, each of which comprises such a needle holder,

[0045] An operating device is used to operate the needle holders to alternately perform the following: a first needle end is held by one of the needle holders and a second needle end is held by another of the needle holders, wherein the first clamp element and the second clamp element are movable relative to each other between a take-over position and an open position, in which the needle-suture assembly can be passed between the needle holders, and in the open position, the first needle holder and the second needle holder are spaced farther apart from each other.

[0046] In one embodiment, the alignment funnel socket includes a funnel surface at an acute funnel surface angle relative to the longitudinal axis of the needle channel, wherein the acute funnel surface angle is substantially equal to or less than a first acute angle of the tip surface of the needle tip. By providing a funnel surface at an angle equal to or less than the angle of the tip surface of the needle tip, the needle tip is prevented from piercing into the funnel surface when the needle end is pushed onto the funnel surface.

[0047] In one embodiment, the needle channel includes: a needle holding portion having a first diameter, in which a needle channel stop surface is arranged; and a tissue receiving channel portion between the needle holding portion and the entrance of the needle channel, the tissue receiving channel portion having a second diameter, wherein the second diameter is larger than the first diameter.

[0048] It has been found that tissue may be pulled into the needle channel as the needle end pierces tissue and is subsequently brought into the needle channel. When the tissue is pulled in the needle holding portion of the needle channel, which typically has a diameter slightly larger than the needle, the needle channel may clamp or get stuck in the needle and / or tissue in the needle channel, resulting in tissue insertion. In order to avoid such a situation, or at least reduce the risk of the needle getting stuck or clamped in the needle channel due to tissue being pulled into the needle channel together with the needle end, a tissue receiving channel portion may be provided for the needle between the entrance and the needle holding portion, the tissue receiving channel portion having a diameter larger than the needle holding portion. The second diameter of the tissue receiving channel portion is selected so that there is a circumferential space around the needle in the tissue receiving channel portion, and tissue can be accommodated in the circumferential space when it is pulled into the needle channel.

[0049] The tissue receiving channel portion should have sufficient length to prevent the tissue pulled into the needle channel from being pulled through the entire tissue receiving channel portion and into the needle holding portion, which is not only to prevent needle jamming or clamping, but also to further reduce damage to the tissue.

[0050] In one embodiment, the length of the tissue receiving channel portion is, for example, at least 1 times, for example, at least 1.3 times, for example, at least 1.5 times, the second diameter, ie, the diameter of the tissue receiving channel portion.

[0051] In one embodiment, the second diameter is in the range of 1.2 to 2.5 times the first diameter, such as in the range of 1.3 to 1.8 times the first diameter, such as about 1.5 times the first diameter. It has been found that the increased diameter of the tissue receiving channel portion is beneficial for accommodating tissue being pulled into the needle channel. The diameter should not be too small to avoid pinching or jamming the needle tissue in the needle channel, but should not be too large to avoid large amounts of tissue being pulled into the needle channel.

[0052] The second diameter may decrease over the length of the tissue receiving channel portion from the entrance toward the needle holding portion. In one embodiment, the second diameter of the tissue receiving channel portion decreases stepwise because the step in the second diameter may effectively prevent tissue from being pulled further into the needle channel.

[0053] It is noted that the tissue receiving channel portion can be used in the needle channel of any needle holder. Therefore, a needle holder is also provided to hold a surgical needle-suture assembly, wherein the needle holder includes a needle channel, which is arranged to receive the needle end of the needle of the needle-suture assembly, and the needle channel includes: an entrance to introduce the corresponding needle end into the needle channel; a needle holding portion having a first diameter; and a tissue receiving channel portion between the needle holding portion and the entrance of the needle channel, the tissue receiving channel portion having a second diameter, wherein the second diameter is greater than the first diameter. Such a needle holder can be provided in a surgical suturing device for passing a double-ended surgical needle-suture assembly forward and backward, wherein the surgical device includes:

[0054] a first jaw element and a second jaw element, each of which comprises such a needle holder,

[0055] An operating device is used to operate the needle holders to alternately hold a first needle end by one of the needle holders and a second needle end by another of the needle holders, wherein the first clamp element and the second clamp element are movable relative to each other between a take-over position and an open position, in which the needle-suture assembly can be passed between the needle holders, and in the open position, the first needle holder and the second needle holder are spaced farther apart from each other.

[0056] The present invention also provides a surgical suturing device for passing a double-ended surgical needle-suture assembly forward and backward, wherein the surgical device comprises:

[0057] a first jaw element, the first jaw element comprising a first needle holder, the first needle holder being configured as the needle holder provided in the present application to hold a first needle end of a needle,

[0058] a second jaw element, the second jaw element comprising a second needle holder, the second needle holder being configured as the needle holder provided in the present application to hold a second needle end of the needle, and

[0059] An operating device is used to operate the first needle holder and the second needle holder to alternately hold the first needle end by the first needle holder and hold the second needle end by the second needle holder.

[0060] As explained above, the needle-suture assembly and the needle are advantageously to be used in a surgical suturing device. In particular, in a surgical suturing device, a combination of a needle end stop surface provided on the needle and a needle channel stop surface in the needle channel is advantageous, wherein the jaw elements are bent or have an internal rotation to partially move the jaw elements from the takeover position toward each other for activating the operating device, such as disclosed in WO 2017 / 155406.

[0061] Further features and characteristics of embodiments of the present invention will be described hereinafter, wherein reference will be made to the accompanying drawings, in which:

[0062] Figure 1 A perspective view showing an embodiment of a surgical stapling device according to the present invention;

[0063] Figure 2 Shown in more detail Figure 1 The distal end of an embodiment of the present invention;

[0064] Figure 3 An embodiment of a needle-suture assembly according to an embodiment of the present invention is shown;

[0065] Figure 4 Show Figure 3 Details of embodiments of the needle-suture assembly;

[0066] Figure 5 shows a cross section of a needle holder according to an embodiment of the present invention;

[0067] Figure 6 Shown is arranged in Figure 1 Needle holder for surgical suturing device Figure 3 and Figure 4 of needles;

[0068] Figure 7 , Figure 8 and Fig. 9 shows a second embodiment of a needle to be used in a needle-suture assembly according to an embodiment of the present invention; and

[0069] Fig.10 Shown in more detail Figure 7 , Figure 8 and Fig. 9 The first needle end of the needle.

[0070] Figure 1 An embodiment of a surgical device of the invention is schematically shown.The surgical device is generally indicated by reference numeral 1 . Figure 2 The distal end of the surgical device is shown in more detail.

[0071] The surgical device 1 comprises a first jaw element 2 and a second jaw element 3. The first jaw element 2 comprises a first needle holder 4 configured to hold a needle end of a needle 100, and the second jaw element 3 comprises a second needle holder 5 configured to hold the opposite needle end of the needle 100.

[0072] The surgical device 1 is configured to pass a double-ended surgical needle 100 forward and backward so that the surgical device can be used to apply sutures to human or animal body tissue. The surgical device 1 can be made of any suitable material, such as (non-toxic and / or biocompatible) plastic or metal, or a combination thereof.

[0073] The proximal ends of the first jaw element 2 and the second jaw element 3 are connected to one another at a proximal end 6 of the device 1 .

[0074] The first jaw element 2 and the second jaw element 3 are movable relative to each other between a take-over position, in which the surgical needle 100 can be taken over between the first needle holder 4 and the second needle holder 5, and an open position, in which the first needle holder 4 and the second needle holder 5 are spaced farther apart from each other. Figure 1 , the surgical device 1 is shown in an open position. In this open position, body tissue can be placed between the needle 100 and one of the first and second jaw elements 2, 3 that does not hold the needle 100.

[0075] A body 7 of the surgical device is provided between the first jaw element 2 and the second jaw element 3. In the body 7, an operating device 8 is arranged, which is configured to operate the first needle holder 4 and the second needle holder 5 to alternately hold the first needle end of the needle 100 by the first needle holder 4 and the second needle end by the second needle holder 5.

[0076] Unless otherwise described and / or shown in the present patent application, the surgical stapling device 1 can be constructed as described and shown in WO 2017 / 155406, the entire contents of which are incorporated herein by reference.

[0077] Figure 1The suturing device 1 is shown in a normal, non-actuated state of the device. The first jaw element 2 and the second jaw element 3 are arranged in an open position. The first needle end of the needle 100 is held by the first needle holder 4, and the second needle holder 5 is spaced apart from the opposite second needle end. In this non-actuated position of the device, the needle 100 can be pierced through body tissue to place a suture, thereby using the suture attached to the needle 100.

[0078] When the needle 100 is correctly placed through the tissue, the first jaw element 2 and the second jaw element 3 can be moved from the open position to the take-over position by applying a pinching force, for example, using the thumb and fingers to apply a pinching force on the first operating surface 29 of the first jaw element 2 and the second operating surface 30 of the second jaw element 3. In the take-over position, the first needle end is still held by the first needle holder 4, and the second needle end is arranged in the second needle holder 5.

[0079] In the take-over position, it is still possible to check whether the needle 100 is correctly placed in the tissue. When it is desired to correct the placement of the needle, the pinching force on the first operating surface 29 and the second operating surface 30 can be released, and the first jaw element 2 and the second jaw element 3 will move back to the open position. When it is not desired to correct the placement of the needle 100, the operating device 8 can be activated to release the first needle end in the first needle holder 4 and simultaneously lock the second needle end in the second needle holder 5.

[0080] In order to activate the operating device 8, the first jaw element 2 and the second jaw element 3 can be moved towards each other from the take-over position in an activation movement. It should be noted that during the activation movement, only the middle part of the first jaw element 2 and the second jaw element 3, i.e. only at the position of the first operating surface 29 and the second operating surface 30, will move towards each other, since the proximal ends of the first jaw element 2 and the second jaw element 3 are connected to each other and the needle 100 prevents further movement of the distal ends of the first jaw element 2 and the second jaw element 3 towards each other.

[0081] This means that during the activation movement, the needle 100 is used as an articulation for the rotation of the first jaw element 2 and the second jaw element 3. Furthermore, the activation movement requires bending of the first jaw element 2 and the second jaw element 3 in order to move the first operating surface 29 and the second operating surface 30 towards each other. In order to facilitate the bending of the first jaw element 2 and the second jaw element 3, the first jaw element 2 and the second jaw element 3 can be provided with a flexible portion 31 near the proximal end 6 of the device 1 (see Figure 1 ), but the first jaw element 2 and the second jaw element 3 are also configured to bend on other parts of the extension of the first jaw element and the second jaw element to allow the first operating surface 29 and the second operating surface 30 to move toward each other from the take-over position.

[0082] When the first jaw element 2 and the second jaw element 3 are released, the first jaw element 2 and the second jaw element 3 will move back to the position as shown in FIG. Figure 1 , but the needle is now held by the second needle holder 5 .

[0083] When the first jaw element 2 and the second jaw element 3 are now moved again from the open position into the takeover position and subsequently moved at least partially further toward each other in an activation movement, the operating device 8 will be activated again to release the second needle end in the second needle holder 5 and simultaneously lock the first needle end in the first needle holder 4.

[0084] Obviously, by subsequently further actuating the device 1 , the needle may be passed forwards and backwards between the first needle holder 4 and the second needle holder 5 to apply a suture through the tissue.

[0085] Figure 3 A needle-suture assembly 101 is shown according to an embodiment of the present invention, which is configured to be Figure 1 and Figure 2 The invention is used in an embodiment of a surgical device.

[0086] Needle-suture assembly 101 includes needle 100 and suture 150. Suture 150 includes connecting ring 151, suture 152, which is only partially shown, and connector 153 that connects suture 152 to connecting ring 151. Connecting ring 151 is made of a wire or thread having a smaller diameter than suture 152.

[0087] Needle 100 comprises a straight needle body 102 having a first needle end 103 and a second needle end 104. A through hole 109 is provided in the middle between the first needle end 103 and the second needle end 104, through which a connecting ring 151 of a suture 150 is arranged to connect the suture 150 to the needle 100.

[0088] Each of the first needle end 103 and the second needle end 104 includes a needle tip 105 , a needle end stop surface 106 , and a circumferential locking groove 107 .

[0089] Needle tip 105 is the pointed end of needle 100 which may be used to pierce tissue or other material through which suture 150 is to be placed.

[0090] The needle end stop surface 106 is arranged to cooperate with the needle channel stop surface of the needle channel of the needle holder 4, 5 (see Figure 5 and Figure 6). By providing a specific needle end stop surface 106 on the needle 100, separate from the needle tip 105, for cooperating with a needle channel stop surface of the needle holder, the contact between the needle end stop surface 106 and the needle channel stop surface can be optimized for the rotation of the first and second jaw elements 2, 3 about the respective needle ends 103, 104. This rotation is necessary for the activation movement of the operating device 8.

[0091] Since the needle end stop surface 106 is arranged to provide contact between the needle 100 and the needle channel to facilitate the rotation of the first and second jaw elements 2, 3 about the respective needle ends 103, 104, it is no longer necessary for the needle tip 105 to provide engagement between the needle 100 and the associated needle channel. As a result, the needle tip 105 of each of the first and second needle ends 103, 104 can be optimized for piercing tissue.

[0092] The circumferential locking groove 107 is a groove extending over the entire circumference of the needle body 102. The locking groove 107 is arranged to receive a needle locking element of a needle holder so as to lock the needle 100 in the needle channel of the needle holder 4,5.

[0093] The needle body 102 has a diameter of about 0.4 mm. The needle body can also have any other suitable diameter. The total length of the needle 100 is, for example, about 10 mm. The length of the needle can be in the range of 7 mm to 12 mm. The needle 100 can be made of any suitable material such as stainless steel.

[0094] Figure 4 The first needle end 103 is shown in more detail. The second needle end 104 has the same construction and dimensions.

[0095] The needle tip 105 comprises a substantially conical tip surface extending at a first acute angle α relative to the longitudinal axis 110 of the needle. The needle end stop surface 106 is also a substantially conical surface at a second acute angle β relative to the longitudinal axis 110 of the needle. The first acute angle α is greater than the second acute angle β. When the needle end stop surface is more parallel to the longitudinal axis 110 of the needle than the tip surface 108 of the needle tip 105, it is advantageous for the first forceps element 4 and the second forceps 5 to rotate about the first needle end 103 and the second needle end 104.

[0096] exist Figure 3 and Figure 4 In the embodiment shown in , the first acute angle α of the needle tip surface is approximately 26 degrees relative to the longitudinal axis 110 of the needle 100 , and the second acute angle β of the tapered surface of the needle end stop surface 106 is approximately 11 degrees relative to the longitudinal axis 110 of the needle 100 .

[0097] More generally, the first acute angle α can be in the range of 15 to 40 degrees relative to the longitudinal axis 110 of the needle 100, for example, in the range of 20 to 30 degrees relative to the longitudinal axis 110 of the needle 100, and the second acute angle β of the needle end stop surface 106 can be in the range of 5 to 20 degrees relative to the longitudinal axis 110 of the needle 100, for example, in the range of 8 to 15 degrees relative to the longitudinal axis 110 of the needle 100.

[0098] Figure 1 and Figure 2 The first needle holder 4 and the second needle holder 5 of the surgical suturing device 1 are designed to be Figure 3 and Figure 4 The needle 100 shown in FIG.

[0099] Figure 5 A cross section of a needle holder 4 is shown. The needle holder 4 comprises a needle channel 10 arranged to receive a first needle end 103 or a second needle end 104 of a needle 100. The needle channel 10 comprises an inlet 11 to introduce the first needle end 103 or the second needle end 104 into the needle channel 10.

[0100] An alignment funnel-shaped socket 13 is arranged at the entrance 11 of the needle channel 10. The alignment funnel-shaped socket 13 is provided to align the needle 100 with the needle channel 10 when the needle 100 is introduced into the needle channel 10. The alignment funnel-shaped socket 13 comprises a funnel-shaped surface 14 with an acute funnel-shaped surface angle γ relative to the longitudinal axis 15 of the needle channel 10. The acute funnel-shaped surface angle γ may be substantially equal to or less than the first acute angle α of the needle tip surface of the needle tip 10.

[0101] In the event that the needle 100 is not fully aligned with the needle channel 10 when introduced into the needle channel 10, i.e., when the longitudinal axis 110 of the needle is not aligned with the longitudinal axis 15 of the needle channel 10, the funnel-shaped surface 14 will guide the first needle end 103 or the second needle end 104 to be pushed against the funnel-shaped surface 14 toward the needle channel 10. This guidance will ensure that the needle 100 is properly aligned with the needle channel 10 to enter the needle channel 10. By making the acute funnel-shaped surface angle γ approximately equal to or smaller than the first acute angle α of the needle, it is prevented that the needle tip 105 of the needle 100 will pierce into the funnel-shaped surface 14 and prevent further movement of the first and second jaw elements 2, 3 to the takeover position and / or further movement that will damage the funnel-shaped surface 14.

[0102] The wide end of the alignment funnel-shaped socket 13 has, for example, a cross-section with a diameter that is at least twice the diameter of the needle, for example at least three times the diameter of the needle.

[0103] It should be noted that Figure 2 A perspective view of the inlet 11 and the alignment funnel-shaped socket 13 of the second needle holder 5 is shown.

[0104] The needle channel 10 includes a needle holding portion 16 having a first diameter and a tissue receiving channel portion 17 between the needle holding portion 16 and the inlet 11 of the needle channel 10 .

[0105] The tissue receiving channel portion 17 has a second diameter that is larger than the first diameter of the needle holding portion 16. In the illustrated embodiment, the first diameter of the needle holding portion 16 is approximately 0.4 mm, i.e., approximately equal to the diameter of the needle 100, and the second diameter is approximately 0.6 mm. As a result, the second diameter is approximately 1.5 times the first diameter. The length of the tissue receiving channel portion 17 is approximately 1 mm. Therefore, the length of the tissue receiving channel portion 17 is approximately 1.7 times the second diameter of the tissue receiving channel portion 17. Since the second diameter is larger than the diameter of the needle 100, when the needle 100 is placed in the needle channel 10, a circumferential space will be formed around the needle in the tissue receiving channel portion 17 (see also Figure 6 ). This circumferential space can be used to receive tissue that is pulled into the needle channel 10 along with the needle 100. By providing a circumferential space, the needle 100 and / or tissue is prevented from being clamped or stuck in the needle channel. Clamping or jamming of the needle 100 may result in incorrect takeover of the needle 100. When the surgeon pulls the surgical stapling device 1 away while the tissue is still held by the surgical stapling device 1, clamping or jamming of the tissue may result in tissue damage.

[0106] It has been found that the above dimensions of the tissue receiving channel portion 17 are suitable for receiving tissue within the tissue receiving channel portion 17 without being pinched or stuck in the needle channel 10, and also preventing the tissue from further entering the needle channel 10, in particular, entering the needle holding portion 16. This ensures the proper operation of the suturing device 1 and avoids damage to the tissue due to inadvertent pulling of the tissue held by the respective needle holders 3, 4.

[0107] The needle holding portion 16 of the needle channel 10 is configured to actually hold the needle 100. The needle holding portion 16 includes a needle channel stop surface 18, which is configured to cooperate with the needle end stop surface 106 of the needle 100. The needle channel stop surface 18 is a conical surface arranged to be at an acute angle θ relative to the longitudinal axis of the needle channel 15, which acute angle substantially corresponds to the second acute angle β of the needle end stop surface 106. Therefore, when the needle 100 is brought into the needle channel 10, the needle end stop surface 106 and the needle channel stop surface 18 will be placed against each other and cooperate with each other to form a support structure that allows some movement of the needle channel stop surface 18 relative to the needle end stop surface 106 to facilitate the rotational movement of the first jaw element 2 and the second jaw element 3 of the surgical suturing device 1 around the corresponding needle ends 103, 104.

[0108] The needle channel 10 further comprises a channel end portion 19 arranged at the smaller side of the tapered needle channel stop surface 18. The channel end portion 19 is arranged to receive the needle tip 105 when the needle 100 is introduced into the needle channel 10 so that the needle tip, once arranged in the needle channel 10, will not contact the wall of the needle channel 10. This avoids that the shape or surface of the needle tip 105 will be damaged due to the pressure exerted by the wall of the needle channel 10 on the needle 100. The channel end portion 19 is an open-ended channel so that any tissue or debris pushed into the channel end portion 19 by the needle 100 can be discharged through the open end of the channel end portion 19.

[0109] The needle holder 4 further comprises a needle locking element 20 arranged in the needle locking element channel 21. The needle locking element 20 can be arranged in a Figure 5 1 and 10. The needle locking element 20 is shown as being moved between an unlocked position and a locked position in which the needle locking element 20 is moved into the needle channel 10 so that the needle locking element 20 is placed in the locking groove 107 of the needle 100 when the needle 100 is arranged in the needle channel 10. As is known in the art, the movement of the needle locking element 20 between the locked position and the unlocked position is operated by the operating device 8. It is noted that the needle locking element channel 21 is also an open-ended channel so that tissue and debris present in the needle channel 10 can also be discharged through the open end of the needle locking element channel 21.

[0110] Figure 6 The first jaw element 2 and the second jaw element 3 are shown in the take-over position, wherein the needle 100 is arranged with a first needle end 103 in the needle channel 10 of the first needle holder 4 and with a second needle end 104 in the needle channel 10 of the second needle holder 5 .

[0111] The needle end stop surface 106 of each respective needle end 103, 104 is arranged to abut against the needle channel stop surface 18 of each needle channel 10. As a result, the first needle holder 4 cannot be moved further towards the second needle holder 5. The needle locking element 20 of the first needle holder 4 is in a locked position, in which the needle locking element 20 extends into the needle locking groove 107 of the first needle end 103. The needle locking element 20 of the second needle holder 5 is in an unlocked position, in which the needle locking element 20 does not extend into the needle locking groove 107 of the second needle end 104.

[0112] In order to transfer the needle 100 from the first needle holder 4 to the second needle holder 5, the operating device 8 should be activated so that the needle locking element 20 of the first needle holder 4 is moved to the unlocked position and the needle locking element 20 of the second needle holder 5 is moved to the locked position.

[0113] As explained above, in order to activate the operating device 8, the first operating surface 29 on the first jaw element 3 and the second operating surface 30 on the second jaw element 4 should be moved toward each other. Because the first needle holder 4 and the second needle holder 5 cannot move toward each other due to the presence of the needle 100, the movement of the first operating surface 29 and the second operating surface 30 toward each other causes the first jaw element 2 to rotate R1 around the first needle end 103 and the second jaw element 3 to rotate R2 around the second needle end 104.

[0114] During the rotation R1, the needle end stop surface 106 of the first needle end 103 and the needle channel stop surface 18 of the first needle holder 4 cooperate with each other to form a bearing structure, thereby facilitating the rotational movement of the first jaw element 3 around the first needle end 103. Correspondingly, during the rotation R2, the needle end stop surface 106 of the second needle end 104 and the needle channel stop surface 18 of the second needle holder 5 cooperate with each other to form a bearing structure, thereby facilitating the rotational movement of the second jaw element 4 around the second needle end 104. The needle tip 105 remains unaffected by these rotations R1, R2.

[0115] Furthermore, it is noted that by providing a straight needle 100 and a circumferential locking groove 107, the needle 100 can be properly arranged in the needle channel 10 regardless of the rotational position of the needle 100 about its longitudinal axis 110. This is advantageous because it is no longer necessary to align the rotational position of the needle 100 relative to the needle channel 10 before loading the needle 100 into the respective needle holder 4, 5.

[0116] Figure 7 , Figure 8 and Fig. 9 A second embodiment of a needle 100 to be used in a needle-suture assembly according to an embodiment of the present invention is shown. Figure 7 and Figure 8 The needle 100 is shown as in Fig. 9 Side view in a first viewing direction x perpendicular to the longitudinal axis 110 of the needle 110 and in a second viewing direction y perpendicular to the longitudinal axis 110 of the needle 110 , as indicated in FIG. Figure 8 The second viewing direction y is relative to Figure 7 The first viewing direction x is rotated 90 degrees. Fig. 9 is parallel to the longitudinal axis 110 of the needle 10, Figure 8 Side view in the indicated viewing direction z.

[0117] The needle 100 is configured to be used in an embodiment of a surgical device, such as Figure 1 and Figure 2 The first needle holder 4 and the second needle holder 5 can be adapted to Figure 7 , Figure 8 and Fig. 9 The shape and size of the needle 100 are shown in FIG.

[0118] The needle 100 comprises a straight needle body 102 having a first needle end 103 and a second needle end 104. A through hole 109 is provided in the middle between the first needle end 103 and the second needle end 104, through which a connecting ring of a suture can be arranged to pass to connect the suture to the needle 100. The suture can be configured, for example, as Figure 3 The suture shown in the figure comprises a connecting ring, a suture and a connector for connecting the suture to the connecting ring.

[0119] Corresponds to Figure 4 In the embodiment, each of the first needle end portion 103 and the second needle end portion 104 includes a needle tip 105 , a needle end stop surface 106 and a circumferential locking groove 107 .

[0120] Needle tip 105 is the pointed end of needle 100 which may be used to pierce tissue or other material through which a suture is to be placed.

[0121] Similar to Figure 4 In the embodiment, the needle end stop surface 106 is arranged to cooperate with the needle channel stop surface of the needle channel of the needle holder 4, 5 (see Figure 5 and Figure 6 ). The shape and size of the needle channel stop surface can be adapted to the shape and size of the needle end stop surface 106.

[0122] Since the needle end stop surface 106 is arranged to provide contact between the needle 100 and the needle channel to facilitate the rotation of the first and second jaw elements 2, 3 about the respective needle ends 103, 104, it is no longer necessary for the needle tip 105 to provide engagement between the needle 100 and the associated needle channel. As a result, the needle tip 105 of each of the first and second needle ends 103, 104 can be optimized for piercing tissue.

[0123] The circumferential locking groove 107 is a groove extending over the entire circumference of the needle body 102. The locking groove 107 is arranged to receive a needle locking element of a needle holder so as to lock the needle 100 in the needle channel of the needle holder 4,5. Figure 7 , Figure 8 and Fig. 9The locking groove 107 of the needle 100 of the embodiment has a tapered base surface. The base surface of the locking groove 107 tapers radially outwardly relative to the longitudinal axis 110 in the direction of the through hole 109. The shape of the needle locking element 20 of the first needle holder 4 and the second needle holder 5 can be adapted to this shape of the locking groove 107. The angle of the base surface of the locking groove 107 relative to the longitudinal axis 110 of the needle 100 can be, for example, 2 to 15 degrees, such as 4 to 10 degrees. Such a tapered base surface of the locking groove can also be applied to any other embodiment of the needle, such as Figure 3 and Figure 4 The embodiment shown in FIG.

[0124] The needle body 102 has a diameter of about 0.4 mm. The needle body can also have any other suitable diameter. The total length of the needle 100 is, for example, about 9 mm. The length of the needle is, for example, in the range of 7 mm to 12 mm. The needle 100 can be made of any suitable material such as stainless steel.

[0125] Fig.10 Shown in more detail Figure 7 , Figure 8 and Fig. 9 The first needle end 103 of the needle 100. The second needle end 104 has the same configuration and size.

[0126] exist Figure 7 , Figure 8 and Fig. 9 In the embodiment of the present invention, the needle tip 105 includes a three-facet needle tip surface formed by three facets 111 evenly distributed on the periphery of the respective needle ends 103, 104. The needle tip surface is the surface defining the needle tip. Figure 3 and Figure 4 The needle of the embodiment shown in FIG. 1 has three facets 111 machined therein.

[0127] The three facets 111 are each arranged at a facet angle φ relative to the needle's longitudinal axis 110. The facets 111 define three needle tip edges 112 arranged at a first acute angle α relative to the needle's longitudinal axis 110.

[0128] The needle end stop surface 106 is a substantially tapered surface at a second acute angle β relative to the needle longitudinal axis 110. The first acute angle α and the facet angle φ are both greater than the second acute angle β.

[0129] exist Figure 7 , Figure 8 and Fig. 9In the embodiment shown in FIG. 1 , the facet angle φ is about 17.5 degrees and the first acute angle α is about 30 degrees relative to the longitudinal axis 110 of the needle 100 . The second acute angle β of the tapered surface of the needle end stop surface 106 is about 9.4 degrees relative to the longitudinal axis 110 of the needle 100 .

[0130] More generally, the facet angle φ and the first acute angle α can be, for example, in the range of 15 to 40 degrees relative to the longitudinal axis 110 of the needle 100, and the second acute angle β of the needle end stop surface 106 can be in the range of 5 to 20 degrees relative to the longitudinal axis 110 of the needle 100, for example, in the range of 8 to 13 degrees relative to the longitudinal axis 110 of the needle 100.

Claims

1. A needle-suture assembly comprising: a straight needle having a first needle end and a second needle end opposite the first needle end, and a suture connected to the needle between the first needle end and the second needle end, wherein each of the first needle end portion and the second needle end portion comprises a needle tip and a locking groove for receiving a locking element of a needle holder, wherein the locking groove extends around the entire circumference of the needle, wherein the first needle end and the second needle end each include a tapered needle end stop surface between the locking groove and the needle tip, wherein the needle end stop surface is arranged to cooperate with a needle channel stop surface of a needle channel of a needle holder, wherein each needle tip comprises a needle tip surface extending at a first acute angle relative to a longitudinal axis of the needle, wherein each needle end stop surface extends at a second acute angle relative to the longitudinal axis of the needle, and Wherein, the first acute angle is greater than the second acute angle.

2. The needle-suture assembly according to claim 1, wherein: The needle tip surface is arranged at a first acute angle in the range of 15 degrees to 40 degrees relative to the longitudinal axis of the needle, and wherein the needle end stop surface is arranged at a second acute angle in the range of 5 degrees to 20 degrees relative to the longitudinal axis of the needle.

3. The needle-suture assembly according to claim 1, wherein: The needle tip surface is arranged at a first acute angle in the range of 20 to 30 degrees relative to the longitudinal axis of the needle, and wherein the needle end stop surface is arranged at a second acute angle in the range of 8 to 15 degrees relative to the longitudinal axis of the needle.

4. The needle-suture assembly according to any one of claims 1 to 3, wherein: The tip surface is at least partially conical.

5. A needle holder for holding a needle-suture assembly according to any one of claims 1 to 4, wherein: The needle holder comprises: a needle channel arranged to receive the first needle end or the second needle end, the needle channel comprising an inlet to introduce a respective one of the first needle end or the second needle end into the needle channel, and a needle locking element for locking the respective needle end in the needle channel, wherein the needle channel includes a needle channel stop surface that cooperates with a needle end stop surface of the needle-suture assembly, Wherein, the needle channel includes: a needle holding part having a first diameter, the needle channel stop surface is arranged in the needle holding part; and a tissue receiving channel part between the needle holding part and the entrance of the needle channel, the tissue receiving channel part having a second diameter, wherein the second diameter is in the range of 1.2 times to 2.5 times the first diameter.

6. The needle holder according to claim 5, wherein: The needle passage stop surface is tapered.

7. The needle holder according to claim 5 or 6, wherein: The needle channel is configured to not contact the needle tip when the needle channel stop surface engages the needle end stop surface.

8. The needle holder according to claim 5 or 6, wherein: The needle channel includes an alignment funnel-shaped socket at the entrance to align the corresponding needle end with the needle channel.

9. The needle holder according to claim 8, wherein: The alignment funnel socket includes a funnel surface at an acute funnel surface angle relative to a longitudinal axis of the needle channel, wherein the acute funnel surface angle is equal to or less than a first acute angle of the tip surface of the needle tip.

10. The needle holder according to claim 5 or 6, wherein: The length of the tissue receiving channel portion is at least 1 times the second diameter.

11. The needle holder according to claim 5 or 6, wherein: The second diameter is in a range of 1.3 to 1.8 times the first diameter.

12. A surgical suturing apparatus for passing a double-ended surgical needle-suture assembly forward and backward, wherein: The surgical suturing device comprises: a first jaw element, the first jaw element comprising a first needle holder, the first needle holder being configured as a needle holder according to any one of claims 5 to 11 for holding a first needle end of the needle, a second jaw element, the second jaw element comprising a second needle holder, the second needle holder being configured as a needle holder according to any one of claims 5 to 11 for holding a second needle end of the needle, and An operating device for operating the first needle holder and the second needle holder to alternately hold the first needle end by the first needle holder and hold the second needle end by the second needle holder.

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