JP7779497B2 - Suture needles and sutures with needles - Google Patents

Description

The present invention relates to suture needles and sutures with attached suture needles for use in surgical procedures such as plastic surgery.

In recent years, minimally invasive surgery has advanced in surgery and plastic surgery, creating a need to reduce post-operative and post-healing scars. To achieve this, it is important to reduce tension around the scar. Increased tension in the scar after suturing reduces blood flow around the scar, slowing wound healing and causing problems. Therefore, subcutaneous or intracutaneous suturing is effective in reducing tension on the skin surface in areas such as joints that move frequently and the abdomen, where abdominal pressure is applied.

In addition, since cosmetic appearance is required when suturing skin, it is important to use suturing techniques that do not expose the suture thread on the surface.

Dermal suture is a technique for suturing the dermis, which is the subcutaneous tissue. It maintains blood flow to the tissue around the scar and reduces tension at the scar, thereby reducing post-operative and post-healing scars (see, for example, Non-Patent Document 1).

Dermal suturing using a conventional, highly curved suture needle (hereinafter referred to as a "conventional needle") 30 will be described below with reference to Figure 9. In Figure 9, the skin structure to which dermal suturing is to be performed comprises epidermis 1, dermis 2, and fat (subcutaneous structure) 3, covering muscle 4.

As shown in Figure 9, when using a conventional needle 30, first, the conventional needle 30 to which the suture 36 is attached is grasped with a needle holder and inserted into the fat 3 (or below the dermis 2) at one wound edge (incision surface) 5, and the needle holder is rotated (Figure 9(a)).

After insertion, the needle is advanced by rotating the needle holder so that the trajectory follows the curvature of the circle, forming an arc, and then withdrawn from above the dermis 2 on one of the incision surfaces 5 (Figure 9(b)).

Next, insert the conventional needle 30 into the upper part of the dermis 2 or into the epidermis 1 on the other incision surface 5, and advance the needle by rotating the needle holder so that the trajectory follows the curvature of the circle, creating an arc, and then withdraw it from below the dermis 2 on the other incision surface 5 (Figures 9(c)-(e)).

Finally, the suture 36 is tied in the fat 3 (or below the dermis 2) (Figure 9(f)). The ligation point 36_2 is shown in the figure.

In this way, with dermal sutures, the dermis 2 is sutured with a stiff needle at a specified depth from the surface of the wound edge. As a result, tension can be reduced in the area from the suture position in the dermis 2 to the surface of the wound edge, and tensile strength can be maintained for a certain period of time, allowing for smooth wound healing.

"How to Care for Surgical Wounds: Aiming for Inconspicuous, Clean Scars" (Supervised by Norihiko Oura, published by 3M Japan Co., Ltd.) https://aaa-amputation.net/wp-content/uploads/2020/11/2020-6-22_3M_Document2.pdf

However, if the distance between the suture position, i.e., the position that causes tension reduction (hereinafter referred to as the "point of tension reduction"), and the surface of the wound edge is increased, the wound edge will not heal well, and even if tension is reduced sufficiently, the cosmetic appearance of the scar will not be improved. As such, it is technically difficult to suture in a specific area of the fat 3 or the lower region of the dermis 2 (subdermal layer) using a conventional high-curvature suture needle (conventional needle) 30.

To perform strong dermal sutures, the suture needle 30 must be advanced from the wound edge (incision surface) 5 deep into the tissue. Furthermore, the epidermis 1 must be everted to prevent it from turning inward (inversion) into the wound.

However, when suturing the dermis using a conventional suture needle 30, the suture needle is advanced along the curvature of a circle, making it difficult to advance the suture needle 30 from the wound edge (incision surface) 5 deep into the tissue and perform suturing.

In addition, to evert the wound, the skin must be pulled upward. If excessive force is applied at this time, it can damage the skin tissue and reduce blood flow around the scar, delaying wound healing. It can also cause necrosis of the wound edge, which is problematic.

In order to solve the above-mentioned problems, the suture needle of the present invention is a suture needle having a pointed tip and a suture thread attached to a base end, and is characterized in that it has a first curved portion on the tip side and a second curved portion on the base end side, the first curved portion and the second curved portion are circular, the second curved portion is more strongly curved than the first curved portion, and the angle formed by a tangent at the base end of the second curved portion and a tangent at the other end opposite the base end is greater than 67.5° and not more than 100°.

Furthermore, the suture needle according to the present invention may be configured so that, after the first curved portion is inserted from the incision surface, it can be advanced deeper into the tissue in accordance with the degree of curvature of the first curved portion.

Furthermore, the suture needle according to the present invention may be configured so that the second curved portion changes its direction of advance toward the incision surface deep in the tissue in accordance with the degree of curvature of the second curved portion.

Furthermore, the suture needle according to the present invention may be configured so that the first curved portion is pulled out in a direction approximately perpendicular to the incision plane, following the degree of curvature of the first curved portion.

Furthermore, in the suture needle according to the present invention, the angle formed by the tangent at the tip and the tangent at the other end opposite the tip in the weakly curved portion may be greater than 0° and not greater than 67.5°.

Furthermore, in the suture needle according to the present invention, the angle formed by the tangent at the base end and the tangent at the other end opposite the base end in the stiff curved portion may be greater than 67.5° and less than 100°.

The suture thread with suture needle according to the present invention comprises the suture needle and suture thread.

The present invention provides a suture needle and a suture thread with a suture needle that can improve the cosmetic appearance of suturing.

FIG. 1 is a schematic diagram of a suture needle according to a first embodiment of the present invention. FIG. 2 is a diagram for explaining the operation of the suture needle according to the first embodiment of the present invention. FIG. 3 is a diagram for explaining an example of the operation of the suture needle according to the first embodiment of the present invention. FIG. 4 is a diagram for explaining an example of the operation of the suture needle according to the first embodiment of the present invention. FIG. 5 is a diagram for explaining the function and effect of the suture needle according to the first embodiment of the present invention. FIG. 6 is a diagram for explaining an example of a suture needle according to the first embodiment of the present invention. FIG. 7 is a diagram for explaining an example of a suture needle according to the first embodiment of the present invention. FIG. 8 is a schematic view of a suture thread with a suture needle according to a second embodiment of the present invention. FIG. 9 is a diagram for explaining the operation of a conventional suture needle.

First Embodiment
A suture needle according to a first embodiment of the present invention will be described with reference to FIGS. 1 to 7. FIG.

<Configuration of suture needle>
1(a) and 1(b) are a perspective view and a side view, respectively, of a suture needle 10 according to the present embodiment.

The suture needle 10 in this embodiment has a curved body 11, a sharp tip (needle tip) 12, and a base end 13 to which a suture thread (not shown) is attached.

There are no limitations on the cross-sectional shape of the main body 11, and it can be circular or polygonal, such as triangular. The cross-sectional shape may also vary in the longitudinal direction of the suture needle 10.

The suture needle 10 is made of stainless steel. Other materials may be used, such as polymers, alloys, or materials with suitable rigidity.

The main body 11 has a circular cross section with a diameter of 0.5 mm at the base end 13, and a tapered shape with a diameter that decreases toward the tip 12, with the tapered shape extending approximately 1 mm from the tip 12.

The base end 13 is provided with a spring hole, which is where a suture (not shown) is attached. The spring hole is a long, narrow hole with a forked tip, and the suture is attached to the suture needle 10 by pressing the side of the suture against the fork and passing it through the hole. The base end 13 is not limited to a spring hole (spring hole), but may also be provided with a regular hole (normal hole). Alternatively, a blind hole of a predetermined depth may be formed in the end surface of the base end 13, and the suture may be attached to the suture needle 10 by inserting the suture into this blind hole and crimping the periphery of the base end 13.

Figure 1(b) shows a schematic side view of the suture needle 10. The section of the body 11 extending a predetermined length from the tip 12 (P1-P2 in the figure) is a weakly curved section (hereinafter referred to as the "weakly curved section" or "first curved section") 14, and the section extending a predetermined length from the base end 13 (P2-P3 in the figure) is a strongly curved section (hereinafter referred to as the "strongly curved section" or "second curved section") 15.

In this way, the second curved portion 15 is more strongly curved than the first curved portion 14. In other words, the second curved portion 15 has a greater degree of curvature than the first curved portion 14, and if the curved portion has a circular shape, the curvature is greater.

As shown in Figure 1(b), the length of the weak curve portion 14 is L1, the length of the strong curve portion 15 is L2, the angle between the tangent line at the boundary between the weak curve portion 14 and the strong curve portion 15 and the tangent line at the tip 12 is θ1, and the angle between the tangent line at the boundary between the weak curve portion 14 and the strong curve portion 15 and the tangent line at the base end 13 is θ2. For the suture needle 10, L1 = 8.7 mm, L2 = 6.7 mm, θ1 = 58°, and θ2 = 90°.

<Suture needle action>

The suturing operation using the suture needle 10 according to this embodiment will be described with reference to Figure 2.

When using the suture needle 10 according to this embodiment, the suture needle 10 to which the suture thread 16 is attached is inserted below the fat 3 or dermis 2 at one wound edge (incision surface) 5, and the suture needle 10 is gently advanced, following the curvature of the weak curve 14 (Figures 2(a)-(b)). As a result, the suture needle 10 can be easily advanced from the insertion point at the wound edge (incision surface) 5 toward the deeper part.

Next, the suture needle 10 is advanced from the insertion point of the wound edge (incision surface) 5, and then the needle holder is rotated to advance the suture needle 10 so that its trajectory forms an arc, following the curvature of the stiff curved portion 15 (Figure 2(b)). In this way, by following the curvature of the stiff curved portion 15, the direction of advancement of the suture needle 10 can be changed in a narrow region deep in the tissue from a direction toward the deep tissue to a direction toward the incision surface 5.

Next, the suture needle 10 is withdrawn from above the dermis 2 or from the epidermis 1 at one of the wound edges (incision surfaces) 5 (Figure 2(c)).

Next, insert the suture needle 10 into the epidermis 1 or above the dermis 2 at the other wound edge (incision surface) 5, and gently advance the suture needle 10 deeper, following the curvature of the weak curve 14 (Figure 2(d)-(e)).

Next, rotate the needle holder so that the suturing needle 10 advances in an arc following the curvature of the stiff curve 15, and pulls it out from beneath the fat 3 or dermis 2 at the other wound edge (incision surface) 5 (Figure 2(f)).

Finally, the suture 16 is tied below the fat 3 or dermis 2 (Figure 2(g)). The ligation point 16_2 is shown in the figure.

Figure 3 shows an example of a suturing operation using the suture needle 10 according to this embodiment. To simplify the explanation, the epidermis 1 is not shown in Figure 3.

During this suturing, as shown in Figure 3(a), fat 3 is peeled away, forming a peeled portion from the incision surface 5. This allows suturing to be performed at a greater distance from the wound edge (incision surface) 5.

First, the suture needle 10 is inserted through the detached portion of the fat 3 at one of the wound edges (incision surfaces) 5 (Figure 3(a)). At this time, the proximal end of the suture needle 10 is strongly curved, making it easy to maneuver and control (insert) the needle in a narrow surgical field.

Next, the suture needle 10 is advanced inside the tissue (Figures 3(b)-(c)). At this time, the tip of the suture needle 10 is slightly curved, allowing it to be easily inserted and advanced a certain distance or more into the subdermal layer.

Next, the suture needle 10 is inserted through the dermis 2 at the other wound edge (incision surface) 5 (Figure 3(d)). At this time, the tip side is slightly curved, so the suture needle 10 can be easily inserted at the appropriate angle. Here, if the tip side is strongly curved, as with conventional needles, a greater wrist movement is required, but if the tip side is weakly curved, as with suture needle 10, the wrist movement can be suppressed and the needle can be easily inserted.

Furthermore, if the needle is strongly curved like a conventional needle, there is a possibility that the base end of the suture needle 10 may crush the epidermis, but if the tip end is weakly curved like the suture needle 10, crushing of the epidermis can be avoided.

Next, the suture needle 10 is advanced inside the tissue (Figure 3(e)). At this time, the tip of the suture needle 10 is slightly curved, allowing it to be easily inserted and advanced a certain distance or more into the subdermal layer.

Next, the suture needle 10 is pulled out from the detached portion of the fat 3 at the other wound edge (incision surface) 5 (Figures 3(f)-(g)). At this time, the proximal end of the suture needle 10 is strongly curved, allowing the suture needle 10 to be easily pulled out in the narrow surgical field.

Finally, the suture 16 is tied to the fat 3 (Figure 3(h)).

Furthermore, as shown in Figure 4, by similarly suturing the superficial layer of the dermis 2, approximately 1 mm below the epidermis, using the suture needle of the present invention (16_3 in the figure), the suture can be made strong and reliable, and the wound edge can be stabilized over the long term. In this case, a suture needle smaller than the suture needle described above can be used.

<Effects of suture needles>
The effects of the suture needle 10 according to this embodiment will be described with reference to Fig. 5. For comparison, Figs. 5(a) and (b) show the case where a conventional needle 30 is used. Fig. 5(c) shows the case where the suture needle 10 according to this embodiment is used.

Dermal sutures involve elevating the skin at the suture site to prevent tension from being placed on the area around the scar while maintaining blood flow to the area. When suturing, it is important to advance the suture needle deep into the tissue to strengthen the suture, and to evert the epidermis 1 so that it does not turn inward (to prevent inversion) into the wound.

When performing dermal sutures using a conventional needle 30, as shown in Figure 5(a), after inserting the suture needle 10 into the tissue from the wound edge (incision surface) 5, the conventional needle 30 is advanced following the curvature of the strong curve. If the conventional needle 30 is advanced deep into the tissue, the needle is likely to be pulled downward from the tissue (arrow 37 in the figure). As a result, the epidermis 1 is pulled downward, which may cause the epidermis 1 to turn inward (invert) into the wound.

Therefore, to avoid inversion of the epidermis 1, when performing dermal sutures using a conventional needle 30, the skin is pulled upward or diagonally upward (arrow 38 in the figure), as shown in Figure 5(b). As a result, the epidermis 1 is everted rather than inverted, and the skin surface is raised for suturing.

In this case, the suture path, i.e., the suture shape created by the suture thread on the cross section of the skin, tends to have a concave portion at the top (skin surface side). Also, the protruding shape tends to have a flat portion on the upper surface.

However, if excessive force is applied when pulling the skin upward, it can damage the skin tissue and reduce blood flow around the scar, delaying wound healing. It may also cause necrosis of the wound edge.

On the other hand, when using the suture needle 10 according to this embodiment, as shown in Figure 5(c), the suture needle 10 is first inserted into the tissue from the incision surface 5, and then advanced following the curvature of the weak curve 14, allowing the needle to be easily advanced deep into the tissue.

Next, the suture needle 10 is advanced so that its trajectory is an arc, following the curvature of the stronger curved portion 15, and then advanced so that it follows the curvature of the weaker curved portion 14 and is withdrawn from the tissue. As a result, the suture needle 10 can be withdrawn in a substantially horizontal direction, i.e., a direction substantially perpendicular to the incision plane 5 (arrow 17 in the figure).

Therefore, by suppressing pulling of the skin upward or diagonally upward (arrow 18 in the figure), the epidermis 1 is everted rather than inverted, allowing the skin surface to be raised and sutured.

At this time, the suture path, i.e., the shape of the suture created by the suture thread on the cross section of the skin, differs from the shape when using conventional needles 30 and has a Mount Fuji-like shape with a convex upper side (skin surface side). In addition, the raised shape of the wound edge also has a convex upper side (skin surface side).

This reduces damage to skin tissue, maintains blood flow around the scar, and allows for faster wound healing.

Furthermore, if the weakly curved portion 14 of the suture needle 10 according to this embodiment is replaced with a straight shape, the suture needle is advanced along the straight shape and then advanced using the strongly curved portion 15, which makes stable suturing operations (needle operation) difficult and may result in breakage of the suture needle or damage to the living body due to centrifugal force.

Furthermore, if the suture needle 10 according to this embodiment is shaped to consist only of a weakly curved portion 14, when the suture needle is advanced deep into the tissue and then advanced toward the tissue surface, the trajectory of the suture needle will be a large arc, making it difficult to advance (maneuver) the needle in a narrow area within the dermis 2.

On the other hand, the suture needle 10 according to this embodiment has not only a weakly curved portion 14 but also a strongly curved portion 15 at the base end, allowing the suture needle to be smoothly withdrawn even in narrow areas, facilitating overall needle movement, ensuring ease of handling, and reducing the strain on the wrist joint.

The suture needle of this embodiment allows the tension reduction point to be secured within the lower dermis at a greater distance from the surface of the wound edge. As a result, the suture needle can be withdrawn in the upper dermis (a shallower region of the dermis), improving the accuracy of wound edge healing.

With the suture needle of this embodiment, the weak curve at the tip makes it easy to predict the needle's trajectory, allowing the needle to be accurately guided and sutured through the subdermis or fat at a greater distance from the wound edge (incision surface) 5.

In addition, when initially inserting the suture needle into the dermis during suturing, the strain on the wrist can be reduced by holding the needle near its base end 13 with a needle holder.

Furthermore, after driving the needle into one wound edge (incision surface) 5 during suturing, when inserting the needle into the other wound edge (incision surface) 5, the weak curve 14 at the tip allows the surgeon to drive the needle without dorsiflexing the wrist. As a result, the needle driving action is smoother overall, reducing the risk of damaging the other wound edge (incision surface) 5 with the base end 13 of the suture needle.

In treatments using the suture needle of this embodiment, improved tensile strength and improved wound edge healing precision can reduce the width of the scar after healing and prevent the re-formation of hypertrophic scars.

In this embodiment, the suture needle has the above-mentioned shape as an example, but is not limited to this. Figure 6 shows the center line of the suture needle 10. Let L1 be the length of the weak curve portion 14, L2 be the length of the strong curve portion 15, θ1 be the angle between the tangent at the tip 12 (P1) of the weak curve portion 14 and the tangent at the other end (P2) opposite the tip 12, and θ2 be the angle between the tangent at the base end 13 (P3) of the strong curve portion 15 and the tangent at the other end (P2) opposite the base end 13. The following relationships can be satisfied: L1 + L2 = 3 to 300 mm, 0° < θ1 ≦ 67.5°, and 67.5° < θ2 ≦ 100°.

It is also desirable that 53°≦θ1≦63°, 85°≦θ2≦95°, and L1+L2 = 8 mm or more and 15 mm or less. It is also desirable that L1/(L1+L2) = 0.3 or more and 0.7 or less.

A linear portion may be included at the boundary between the weakly curved portion 14 and the strongly curved portion 15. Also, a linear portion may be included at the distal end 12 or the proximal end 13. The length of the linear portion may be within a range that allows the suture needle 10 to achieve the above-described effects.

In this embodiment, a circular shape is used as the curved shape, but other curved shapes such as an ellipse or a quadratic function curve may also be used, as long as the curved shape falls within the shaded area shown in Figure 7 (for example, the solid line in the figure).

When operating the suture needle, the needle is advanced by following the degree of curvature of the curved portion (or the curvature if the curved shape is circular).

Second Embodiment
A suture with a suture needle according to a second embodiment of the present invention will be described with reference to FIG.

<Configuration of suture with suture needle>
8 shows a perspective view of the suture thread 20 with a suture needle according to this embodiment. The suture thread 20 with a suture needle according to this embodiment comprises the suture needle 10 according to the first embodiment and a suture thread 21.

The suture needle 10 has a body 11, a tip 12, and a base 13. The suture thread 21 is inserted into a blind hole provided in the base 13 and attached to the suture needle 10 by crimping the periphery of the base 13. The suture thread 21 may also be attached to the suture needle 10 by heat treatment, adhesive, or the like.

The suture 21 is made of nylon monofilament (single thread) and has a diameter of 0.05 mm. The suture 21 may also be made of polyester, silk, or braid (knitted thread). The diameter may be between 0.001 mm and 0.8 mm. The suture 21 may also be synthetic absorbable thread, and may be made of monofilament or braid.

The suture thread with suture needle according to this embodiment achieves the same effects in suturing as the first embodiment.

Suture needles in embodiments of the present invention may be round needles with conical tips, square needles with triangular pyramidal tips (sharp on the inside of the curve), inverted triangular needles with triangular pyramidal tips (sharp on the outside of the curve), tapered-cut needles where the entire needle is cylindrical but only the tip is triangular pyramidal, or blunt needles, which are round needles with a slightly rounded, blunt tip. The tip may also be an inverted square needle with an inverted triangular cross section, or a spatula-shaped inverted square needle with the tip (apex) removed.

In the embodiments of the present invention, the length of the suture needle is 4.5 mm or 5 mm, and the needle diameter is 100 μm, but this is not limited to these. The length of the suture needle can range from 1 mm to 100 mm, and the needle diameter can range from 50 μm to 1.5 mm. In particular, for microsurgery such as brain surgery, a length of 3 mm to 7 mm and a needle diameter of 50 μm to 250 μm are desirable. The length of the suture needle is desirable to be 9 mm to 24 mm for vascular suturing, 10 mm to 70 mm for surgical procedures, and 9 mm to 25 mm for plastic surgery.

The suture needle according to the embodiment of the present invention is manufactured using the usual manufacturing method. For example, after cutting the stainless steel material to the specified length, a hole for the suture thread is formed. Next, the tip and main body (body) are processed, including the formation of the curved portion, and then polished and sterilized.

In the embodiment of the present invention, an example of application to dermal suturing is shown, but it can also be applied to subcutaneous suturing in surgical procedures such as plastic surgery, brain surgery, and gastrointestinal surgery.

In the embodiments of the present invention, examples of the structure, dimensions, materials, etc. of each component in the configuration and operation of the suture needle and suture thread with suture needle are shown, but this is not limiting. Anything that can fulfill the function and effect of the suture needle will suffice.

The present invention has industrial applicability as a medical device for use in surgical procedures such as plastic surgery, neurosurgery, and gastrointestinal surgery, in the form of a suture needle and a suture thread with a suture needle attached.

10 suture needle 11 body 12 tip 13 base end 14 weak curve portion 15 strong curve portion 16, 21 suture thread 20 suture thread with suture needle

Claims (3)

A suture needle having a sharp tip and a suture thread attached to a base end,
A first curved portion is provided on the distal end side, and a second curved portion is provided on the proximal end side,
the first curved portion and the second curved portion are circular,
the second curved portion is stronger than the first curved portion;
a tangent line at the base end of the second curved portion to a tangent line at the other end opposite the base end, the angle being greater than 67.5° and not greater than 100°; The suture needle according to claim 1, wherein an angle formed between a tangent at the tip end of the first curved portion and a tangent at the other end opposite the tip end is greater than 0° and not greater than 67.5°. The suture needle according to claim 1 or 2 ;
A suture with a suture needle comprising: a suture;