JPWO2017122319A1 - Surgical staples - Google Patents

Abstract

The surgical staple (1) protrudes in a direction intersecting the longitudinal direction of the base portion (2) from the base portion (2) having one end portion (2a) and the other end portion (2b), An insertion portion (3) on which a pressing force (F) in a predetermined direction acts by contact with the anvil of the stapler, and the insertion portion (3) has an inner side surface (5) positioned on the other end side, and others The outer side surface (6) located on the opposite side to the end portion, and the needle tip portion (4) formed by the inner side surface (5) and the outer side surface (6) at the tip, and the outer side surface (6 ) And the inner side surface (5) have such shapes that the angles (θ1, θ2) formed by the respective tangents (T1, T2) and the predetermined direction in the needle tip (4) satisfy the conditional expression (1). Have. (1) 60 °> θ1> θ2> 0 °

Description

  The present invention relates to surgical staples.

  Conventionally, a stapler has been used to suture a living tissue (for example, see Patent Document 1). A staple used as a needle for a stapler has a long base portion and a needle-like insertion portion that protrudes from one end of the base portion in a direction intersecting the longitudinal direction of the base portion. The staple insertion portion disclosed in Patent Document 1 is greatly curved so that the distal end of the insertion portion is located at substantially the same position as the other end of the base portion in the longitudinal direction of the base portion.

US Pat. No. 8,662,369

However, although the insertion part of Patent Document 1 is easily deformed by an anvil, there is a problem that it is difficult to puncture a living tissue because the distal end of the insertion part faces a direction substantially parallel to the longitudinal direction of the base part. .
The present invention has been made in view of the above-described circumstances, and an object of the present invention is to provide a surgical staple that can easily deform an insertion portion and reliably puncture a living tissue.

One aspect of the present invention is a surgical staple which is used in a surgical stapler having an anvil and a cartridge, and is pushed toward the anvil from the inside of the cartridge and is subjected to a pressing force in a predetermined direction by contact with the anvil. An elongated base portion having one end portion and the other end portion, and an insertion portion projecting from the one end portion of the base portion in a direction intersecting the longitudinal direction of the base portion and deformable by the pressing force And the insertion portion is formed by an inner side surface located on the other end side, an outer side surface located on the opposite side of the other end portion, and the inner side surface and the outer side surface at the tip. A surgical staple having a shape that satisfies the following conditional expression (1).
(1) 60 °>θ1>θ2> 0 °
However, (theta) 1 is the angle which the tangent of the direction along the plane demarcated by the base part and the insertion part in the needle point part of the outside side and the predetermined direction makes, and theta 2 It is an angle formed by a tangent in a direction along the plane at the needle tip portion of the inner side surface and the predetermined direction.

  According to the present invention, there is an effect that the insertion portion can be easily deformed and the living tissue can be reliably punctured.

(A), (b), (c) It is a figure which shows the process in which the surgical staple which concerns on one Embodiment of this invention is deform | transformed by the surgical stapler. It is a front view showing the whole surgical staple composition concerning one embodiment of the present invention. It is a front view which shows the whole structure of the 1st modification of the surgical staple of FIG. It is a front view which shows the whole structure of the 2nd modification of the surgical staple of FIG.

Below, the surgical staple 1 which concerns on one Embodiment of this invention is demonstrated with reference to drawings.
First, a surgical stapler in which the surgical staple 1 according to this embodiment is used will be described.
As shown in FIGS. 1A to 1C, the surgical stapler is an instrument for suturing a living tissue S with a surgical staple 1, and includes a cartridge 11 and an anvil 12 interconnected so as to be openable and closable. It has. The cartridge 11 and the anvil 12 have inner surfaces 11a and 12a facing each other in parallel in the closed state, and the living tissue S is held between the inner surface 11a and the inner surface 12a.

  A slot 11 b is opened in the inner surface 11 a of the cartridge 11. The surgical staple 1 is accommodated in the slot 11b and is pushed out of the slot 11b by the operation of an unillustrated push-out mechanism. The surgical staple 1 pushed out from the inside of the slot 11b penetrates the living tissue S and then contacts the inner surface 12a of the anvil 12 as shown in FIG. At this time, a pressing force F in a predetermined direction corresponding to the force applied to the surgical staple 1 from the pushing mechanism is applied to the surgical staple 1 that contacts the inner surface 12a of the anvil 12. As shown in FIGS. 1B and 1C, the surgical staple 1 is deformed by the pressing force F, and the living tissue S is sutured.

Next, the surgical staple 1 according to this embodiment will be described.
As shown in FIG. 2, the surgical staple 1 is substantially L-shaped and includes a long base portion 2 and a single insertion portion 3 extending from one end of the base portion 2. . The substantially L-shape means a shape in which the insertion portion 3 extends from one end of the base portion 2 in a direction intersecting the longitudinal direction of the base portion 2.
The base portion 2 and the insertion portion 3 are made of a metal having high biocompatibility such as titanium alloy and stainless steel.

The base 2 has a first end (one end) 2a and a second end (other end) 2b at both ends in the longitudinal direction.
The insertion portion 3 is a portion that penetrates the living tissue S and is curved and deformed by the anvil 12. The insertion portion 3 is connected to the first end portion 2a of the base portion 2 at one end, and protrudes from the first end portion 2a in a direction intersecting the longitudinal direction of the base portion 2. The insertion portion 3 has an arc shape that is convex on the opposite side to the base portion 2. The shape of the insertion portion 3 is not limited to an arc shape having a constant curvature, and may be an arc shape in which the curvature changes between one end and the other end.

  Hereinafter, the longitudinal direction of the base portion 2 is the X direction, the direction perpendicular to the longitudinal direction of the base portion 2 along the plane defined by the base portion 2 and the insertion portion 3 (the same plane as the paper surface in FIG. 2) is the Z direction, Description will be made using an XYZ orthogonal coordinate system in which the direction perpendicular to the plane (XZ plane) is the Y direction.

  The insertion portion 3 includes an inner side surface 5 located on the radially inner side (second end 2b side) of the arc shape, and an outer side surface 6 located on the radially outer side (opposite side to the second end portion 2b). ,have. The other end (tip) of the insertion portion 3 is provided with a needle tip portion 4 formed of a corner portion formed by connecting the edge of the inner side surface 5 and the edge of the outer side surface 6. The needle tip portion 4 is located closer to the second end portion 2b than the first end portion 2a in the longitudinal direction of the base portion 2, and preferably between the first end portion 2a and the second end portion 2b. Located between.

As shown in FIG. 2, when the surgical staple 1 is viewed in the Y direction, the inner side surface 5 and the outer side surface 6 satisfy the following conditional expression (1) when the first angle θ1 and the second angle θ2 are satisfied. It has such a shape.
(1) 60 °>θ1>θ2> 0 °

In the formula (1), the first angle θ1 is an angle formed by the tangent line T1 in the direction along the XZ plane in the needle tip portion 4 of the outer side surface 6 and the direction of the pressing force F. The second angle θ2 is an angle formed by the tangent line T2 along the XZ plane in the needle tip portion 4 of the inner side surface 5 and the direction of the pressing force F.
More preferably, the first angle θ1 is 38 ° ± 2 °. By doing in this way, the puncture performance of the needle tip part 4 with respect to the biological tissue S can be improved, and the deformation of the insertion part 3 by the anvil 12 can be facilitated.

  In the present embodiment, it is assumed that the surgical staple 1 is pushed out from the slot 11b in the Z direction perpendicular to the longitudinal direction of the base portion 2, and the direction of the pressing force F is the Z direction. Accordingly, the first angle θ1 is equal to the angle formed by the tangent line T1 and the Z direction, and the second angle θ2 is equal to the angle formed by the tangent line T2 and the Z direction.

  The length dimension L3 in the direction of the pressing force F of the insertion part 3 is larger than the length dimension L2 of the base part 2 in the X direction. Thereby, the insertion portion 3 is more easily deformed by the pressing force F.

The surface roughness R1 of the outer side surface 6 and the surface roughness R2 of the inner side surface 5 satisfy the following conditional expression (2).
(2) R1 <R2
By making the surface roughness R1 smaller than the surface roughness R2 as described above, the deformation of the insertion portion 3 by the anvil 12 and the stability of the insertion portion 3 with respect to the biological tissue S after puncturing the biological tissue S are performed. And both can be achieved.

  In the process of deformation of the insertion portion 3 by the anvil 12, the contact position between the outer side surface 6 and the anvil 12 is the root portion 7 that is the end portion of the insertion portion 3 opposite to the needle tip portion 4 from the needle tip portion 4. Move towards. Therefore, in order to make deformation of the insertion portion 3 by the anvil 12 easier, the friction between the outer side surface 6 and the anvil 12 is preferably small, and the surface roughness R1 of the outer side surface 6 is preferably smaller. . In order to reduce the surface roughness R1, the outer side surface 6 may be subjected to mechanical processing such as mirror polishing or surface processing such as coating.

  On the other hand, in order to prevent the insertion part 3 from coming out of the biological tissue S after puncturing the biological tissue S and to improve the stability of the insertion part 3 with respect to the biological tissue S, between the insertion part 3 and the biological tissue S. It is preferable that the friction is large. Therefore, it is preferable that the surface roughness R2 of the inner side surface 5 is larger.

  The insertion portion 3 is formed so as to gradually become thicker from the needle tip portion 4 toward the root portion 7. Thereby, the cross-sectional secondary moment around the axis in the Y direction at each position between the base portion 2 and the insertion portion 3 of the insertion portion 3 continuously increases from the needle tip portion 4 toward the root portion 7. Yes. Therefore, in the process of deformation by the anvil 12, the insertion portion 3 is deformed in order from the needle tip portion 4 toward the root portion 7.

Next, the operation of the surgical staple 1 thus configured will be described.
The surgical staple 1 is accommodated in the slot 11b with the needle tip 4 facing the anvil 12, and the base portion 2 is supported in the slot 11b so as to be parallel to the inner surface 11a. As a result, the surgical staple 1 is pushed out of the slot 11b in a direction perpendicular to the inner surfaces 11a and 12a by the operation of an unillustrated push-out mechanism.

  The insertion portion 3 pushed out from the inside of the slot 11b punctures the living tissue S by the needle tip portion 4 and penetrates the living tissue S from the cartridge 11 side, and then, as shown in FIG. The tip 4 contacts the inner surface 12 a of the anvil 12. And the insertion part 3 begins to bend by the pressing force F of the Z direction which goes to the base part 2 acting on the needle tip part 4 which contacts the inner surface 12a of the anvil 12.

  As the amount of protrusion of the insertion portion 3 from the slot 11b increases, the contact position of the insertion portion 3 with the inner surface 12a of the anvil 12, that is, the position where the pressing force F acts is the needle along the outer side surface 6 of the insertion portion 3. It moves from the front part 4 toward the root part 7. At this time, since the insertion portion 3 has a cross-sectional secondary moment that gradually increases from the needle tip portion 4 toward the root portion 7, the insertion portion 3 has a main deformation portion from a portion having a small cross-sectional secondary moment. The plastic deformation occurs while changing to a portion where the moment of inertia of the section is large.

  An anvil pocket for bending the insertion portion 3 into a C shape is formed at a position facing the slot 11b of the inner surface 12a of the anvil 12. Accordingly, as shown in FIGS. 1B and 1C, the insertion portion 3 is deformed into a C shape and penetrates the living tissue S again from the anvil 12 side. Thereby, the biological tissue S can be stably sutured at two locations.

  In this case, according to the present embodiment, since the second angle θ2 is further smaller than the first angle θ1 that is less than 60 °, the inner side surface 5 is punctured with the living tissue S. The living tissue S is contacted at an angle close to perpendicular to the surface of the living tissue S on the inner surface 11a. Thereby, there exists an advantage that the needle tip part 4 can puncture the biological tissue S reliably, and the insertion part 3 can be penetrated to the biological tissue S reliably.

  Further, since the first angle θ1 is less than 60 ° and the second angle θ2 is larger than 0 °, the angle formed by the inner side surface 5 and the outer side surface 6 in the needle tip portion 4 is an acute angle, and the sharpness A sharp needle tip 4 is formed. The angle at the tip of a tool such as a drill for penetration is about 120 °. By making the first angle θ1 less than half of the angle at the tip of such an instrument, the puncture performance of the needle tip portion 4 can be improved, and the needle tip portion 4 can be punctured into the living tissue S more reliably. .

  Further, since the first angle θ1 is less than 60 °, the outer side surface 6 is in contact with the inner surface 12a at an angle when the needle tip portion 4 is in contact with the inner surface 12a of the anvil 12. Therefore, a bending moment that causes the insertion portion 3 to bend and deform is generated in the insertion portion 3 by the pressing force F. Thereby, there exists an advantage that the insertion part 3 can be bend-deformed easily. Further, the bending moment that acts on the needle tip portion 4 when the needle tip portion 4 serving as the point of application of the pressing force F is located at a position shifted to the second end portion 2b side from the root portion 7 serving as the fulcrum. Becomes larger. Thereby, there exists an advantage that the bending deformation of the insertion part 3 can be made still easier. In particular, when the first angle θ1 is 38 ° ± 2 °, both the ease of puncture of the needle tip portion 4 into the living tissue S and the ease of deformation of the insertion portion 3 by the anvil 12, High effect can be obtained.

In the present embodiment, as shown in FIG. 3, a barb 8 may be provided on the inner side surface 5 of the insertion portion 3.
The barb 8 is formed to stop the movement of the living tissue S relative to the insertion part 3 in the direction from the needle tip part 4 toward the root part 7. Thereby, it can prevent more reliably that the insertion part 3 slips out from the biological tissue S.

In the present embodiment, the surgical staple 1 is provided with the single insertion portion 3, but instead, it is provided with a space in the longitudinal direction of the base portion 2 as shown in FIG. A plurality of inserted portions 3 may be provided.
By doing so, the living tissue S can be sutured more efficiently. In this modification, the length dimension L3 of the insertion part 3 is designed so that the sum of the length dimensions L3 of the plurality of insertion parts 3 is larger than the length dimension L2 of the base part 2.

  In the present embodiment, the direction of the pressing force F acting on the insertion portion 3 is a direction perpendicular to the longitudinal direction of the base portion 2, but the direction of the pressing force F is not limited to this. The cartridge 11 and the anvil 12 can be changed as appropriate according to the design. Therefore, the shapes of the inner side surface 5 and the outer side surface 6 are appropriately designed according to the direction of the pressing force F.

DESCRIPTION OF SYMBOLS 1 Surgical staple 2 Base part 2a 1st edge part (one end part)
2b Second end (other end)
DESCRIPTION OF SYMBOLS 3 Insertion part 4 Needle-tip part 5 Inner side surface 6 Outer side surface 7 Root part 8 Return 11 Cartridge 12 Anvil 11a, 12a Inner surface

Claims (5)

A surgical staple that is used in a surgical stapler having an anvil and a cartridge, is pushed toward the anvil from within the cartridge, and is applied with a pressing force in a predetermined direction by contact with the anvil,
An elongated base having one end and the other end;
An insertion part protruding from the one end of the base part in a direction intersecting the longitudinal direction of the base part, and deformable by the pressing force;
With
The insertion portion includes an inner side surface located on the other end side, an outer side surface located on the opposite side of the other end portion, and a corner formed by the inner side surface and the outer side surface at the tip. A needle tip portion,
The surgical staple having a shape in which the outer side surface and the inner side surface satisfy the following conditional expression (1).
(1) 60 °>θ1>θ2> 0 °
However,
θ1 is an angle formed by a tangent line in a direction along a plane defined by the base portion and the insertion portion in the needle tip portion of the outer side surface and the predetermined direction;
θ2 is an angle formed by a tangent line in the direction along the plane of the needle tip portion of the inner side surface and the predetermined direction. The surgical staple according to claim 1, wherein the needle tip portion is located closer to the other end portion than the one end portion of the base portion in a direction perpendicular to the predetermined direction. The surgical staple according to claim 1 or 2, wherein a surface roughness of the outer side surface is smaller than a surface roughness of the inner side surface. The cross-section secondary moment about an axis in a direction perpendicular to the plane in the insertion portion continuously increases from the needle tip portion toward a root portion connected to the one end portion. The surgical staple according to any one of 3 above. The surgical staple according to any one of claims 1 to 4, wherein a dimension of the insertion portion in the predetermined direction is larger than a dimension of the base portion in a longitudinal direction.

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