JP2672713B2 - Surgical equipment - Google Patents

Description

FIELD OF THE INVENTION The present invention relates to staples, and in particular to improved staples used in surgery and other fields.

BACKGROUND OF THE INVENTION Staples have many uses. For example, a surgeon may connect the cut ends of a hollow organ or tubular structure (anastomosis)
And use thin wire staples to stop the bleeding.
Thin wire staples are formed by deforming a length of thin wire having a uniform cross section and material properties into a U shape. FIG. 1 shows a prior art thin wire staple 100 including a crown 101 and two legs 102. FIG.
Although the staple shown in Figure 1 has a uniform cross section and material properties, the material properties change during the deformation of the wire into a U-shape at the staple leg to crown bond region. Surgical staples are formed of materials that are inert to attacks by body fluids such as stainless steel.

When installing staples, press the legs against the material that holds them in place. Upon installation, some staples deform, that is, bend beyond their elastic limit to permanently change shape.

FIG. 2 shows the staple of FIG. 1 deformed into a B shape when installed by biasing the leg into an anvil having channels for guiding the leg as it flexes and deforms. The anvil is located on the side of the staple that is opposite the side on which the staple is inserted. Deformation of the staple of FIG. 1 occurs where bending stress is maximized.

FIG. 2 shows a state in which the leg portions 102 are separated from the crown 101 at different positions and changed into B-shaped staples. in this way,
When B-shaped staples are used in surgery, the tissue located between the legs and the crown is subject to varying degrees of compression depending on the area.

Tissues that have been minimally compressed by staples for hemostasis using staples have been identified as hemostasis cells that are maximally compressed may be lost or damaged by overcompression or strain. Therefore, it will be further compressed. It is important not to form more scar tissue than necessary, as prolonged shrinkage of scar tissue can lead to poor results.

Despite the need to prevent the development of excessive scar tissue, some surgeons may find that a controlled, small amount of tissue damage means that the amount of scar tissue formed as a result of tissue damage is excessive, i.e., formation. The damaged scar structure is B of the prior art.
It is claimed to be sometimes beneficial if the use of shaped staples does not cause problems leading to excessive scar tissue.

An object of the present invention is to provide a staple that uniformly compresses a stapled object.

A further object of the present invention is to provide a surgical staple that minimizes scar tissue formation.

A further object of the present invention is to provide a staple that minimizes distortion of the stapled product.

A further object of the present invention is to provide a surgical staple that minimizes adhesion time.

A further object of the present invention is to provide a staple that minimizes damage to the stapled material.

Further, it is an object of the present invention to provide a surgical staple capable of controlling scar tissue formation to a small amount.

SUMMARY OF THE INVENTION The above problems and other problems are solved by the present invention, and the problem of the present invention is that deformation resistance occurs selectively in a predetermined area at the time of installation, and deformation occurs preferentially in a weak area in the predetermined area. Deformation is achieved by the present invention for improved staples where deformation does not occur selectively in non-weak areas. The predetermined region having a small resistance to deformation is hereinafter referred to as a “deformation region”. The deformation area reduces the minimum moment of inertia I of the staple cross section in the deformation area,
It can also be formed by reducing the elastic modulus E of the staple material.

In a preferred embodiment of the staple of the present invention, the staple has two legs, each leg having a deformation area in a predetermined area, and the deformation area is under stress caused when the staple abuts the anvil during setting. , And is separated from the crown of the staple via a leg region having a resistance greater than that of the deformation region, whereby the staple is selectively deformed in the deformation region.

Upon installation, the staple of the present invention preferably deforms into a rectangle with rounded corners. This allows for uniform compression of the stapled object and helps minimize its deformation.

 FIG. 1 shows a prior art staple prior to installation.

FIG. 2 shows the prior art staple of FIG. 1 after being deformed into a B shape.

 FIG. 3 illustrates an exemplary embodiment of the staple of the present invention.

 FIG. 4 shows the staple of FIG. 3 after being transformed into a rectangle.

FIG. 5 shows an exemplary cross-sectional view (different from the scale of the staple 3) of the possible deformation area and the adjacent leg area of the staple of FIG.

FIG. 6 shows a doubled staple line which is alternately arranged.

FIG. 7 is a sectional view of a front portion of the first type exemplary anvil.

FIG. 8 is a sectional view of a front portion of a second type exemplary anvil.

FIG. 9 illustrates one embodiment of a stepper jaw device according to the present invention.

FIG. 10 shows a staple loading strip (cartridge) for use in the present invention.

FIG. 11 shows another embodiment of the invention in which the deformation zone is formed simultaneously with the stapling device.

 FIG. 12 shows the embodiment of FIG. 11 in use.

FIG. 13 shows a cross-sectional view of another embodiment of a staple of the present invention fully deformed and placed on tissue.

FIG. 14 shows another embodiment of the staple of the present invention before deformation and installation.

FIG. 15 shows a cross-sectional view of a prior art staple that has been fully deformed into a B shape and placed in tissue.

 FIG. 16 shows a method of forming a deformation zone.

FIG. 17 shows a view of the notch formed on the leg of the staple.

Detailed Description of the Preferred Embodiments The deformation zone is formed by weakening the staples in that area so that deformation occurs preferentially in a given area during staple placement. As is known in the art, the resistance of a staple to deformation under stress in one region depends on the modulus of elasticity E in that region and the degree of inertia moment I in that region. Reducing one or both of the properties of one area reduces the stress required to deform the staples in that area. It is usually easier to make I smaller than E.

Deformation areas should not be formed by weakening the staples in certain areas in such a way that upon staple deformation the staples fail, i.e. break.

The staple legs of the present invention must be compatible with the requirements of the stapled item. That is, the location of the deformation zone must be compatible with the thickness of the stapled object and the desired compression, and the length of the staple legs is to provide uniform compression of the stapled object. It must be possible to approach both legs and to prevent the projection of an object from between the tips of the legs.
Such adaptation may require the use of multiple staples, but is justified when compression is performed and its uniformity is important.

FIG. 3 illustrates an exemplary stapler 300 according to the present invention. The staple 300 has a crown 301 and two legs 302. Each leg 302 is 3 compared to the resistance of the leg regions 306 and 307.
It has a deformation area 305 with a small resistance to bending in the 04 direction. The leg regions 306 and 307 are outside the deformation zone 305.
When the staples 300 are stressed by the force acting in the direction of 304, the legs bend in that direction, and bending and deformation preferentially occur in the deformation region 305.

In FIG. 4, the staple of FIG. 3 is shown in a deformed rectangular shape. The staples of FIG. 3 are placed under more uniform compression than the B staples of FIG. FIG. 4 illustrates the location and length of the deformation zone 305, and the length of the staple legs 302 to obtain the desired compression for a stapled object having a particular thickness, and also the ends or tips of the staple legs. It is shown that this is an important parameter for the legs to approach them. Ideally, the tips of the staple legs are in contact with each other.
The length of the leg region 306 between the crown 301 and the deformation zone 305 is suitable for the requirements set depending on the thickness of the material to be stapled and the desired compression force of the material. The length of the leg region 307 between the deformation area 305 and the leg end 308 is a minimum, without the separation of the leg ends 308 of the deformed staple interfering between the leg ends 308 due to deformation during staple placement. Should be selected.

A comparison of FIGS. 2 and 4 shows that the staple 300 clamped in FIG. 3 has less distortion and more uniform compression than the B-shaped staple.

5, an exemplary cross-section (not shown to scale of FIG. 3) of leg 302 of FIG. 3 is shown. In FIG. 5A, a cross-sectional view of a region outside the deformation region 305 of the leg portion 302 of the staple is shown. 5 (b) and (c),
Two different possible cross-sections are shown as cross-sections of the staple leg deformation area 305. The value of the deformation area I of the leg portion of the staple having the cross section shown in FIG. 5 (b) or (c) bent in the direction of 304 is smaller than that in the case having the cross section of FIG.

In FIG. 6, double alternating side-by-side staple lines 600 formed from the inventive staples of FIG. 4 are shown, with each row offset from the other. Surgeons use double alternating staple lines to compress or anastomose tissue for hemostasis, for example at the cut end of an organ. The staples of the present invention thus have applications in, for example, hemostasis and anastomosis.

7, a cross section of an anvil 700 used in the staple of FIG. 3 to form the modified staple of FIG. 4 is shown. Channel 701 formed on anvil 700
Allows the staple leg 302 to bend and deform when the staple 300 biases the anvil 700 and the leg 302 abuts the anvil 700. Anvil 700 is fixed when biasing staples 300.

In FIG. 8, FIG. 7 used for the staple 300 of FIG.
Anvil 800 is shown in a different embodiment. The legs 302 of the staples 300 are inserted into the staples (not shown in FIG. 8) and then channel 801 of the anvil 800.
Abut. Anvil 800, staple 300 anvil
When biased to 800, it moves towards staple 300. Movement of the anvil can be accomplished using means well known in the art. The movement of the anvil minimizes strain on the objects that are clamped by the staple legs 302 as they flex and deform.

As shown in FIG. 4, the legs 302 after the staple 300 is deformed do not follow the shape of the channel 701. rather,
The ends 308 of the legs 302 follow the shape of the channel 701 so that the leg regions 306 and 307 bend at an angle to each other (preferably right angles). The stepper has stoppers (702,80) to prevent the staples from bending more than a predetermined value.
Although it has 2), such a stopper is not necessary for installing staples. Although exemplary stoppers (702, 802) are shown, other methods using means well known in the art can be used to prevent the stapler jaws from approaching enough to deform the staples beyond the desired point. it can.

The stepper jaws are usually parallel to each other when the thickness of the stapled object is uniform, but the object thickness may vary over the length of the stepper line to be inserted . In FIG. 9, another staple jaw device 900 is shown which includes two stepper jaws 901 and 902 (jaw 902 functions as an anvil). This embodiment can be used when the thickness of the staples varies over the length of the staple line the surgeon desires to insert.

To maximize the benefits of the present invention and obtain good results, the upper jaw 901 is inclined with respect to the lower jaw 902 as shown. As a result, the separation of the stepper jaws 901 and 902 is stapled (not shown in FIG. 9).
Changes in response to changes in the thickness of.

The individual staples used in the apparatus of FIG. 9 have leg deformed areas at different positions relative to each other to accommodate changes in the thickness of the stapled object. In particular, as can be seen in FIG. 9, the staple contacting the channel 903 has a shorter leg between the staple deforming region and the staple crown than the staple contacting the channel 904. Further, the staple leg length used in channel 903 may be shorter than the staple leg length used in channel 904.

The staples of the present invention are compatible with the requirements of the stapled article because the staples of the present invention are manufactured with uniform cross-sections and material properties, and the surgeon can deform the staples just prior to use to create a deformation zone. For example, the surgeon may notch or bind the legs of the staple to create the zone of deformation and / or cut the legs of the staple to the desired length. Means well known in the art can be used as a device that can be used for such a purpose.
Such attempts reduce the size of staples as an inventory requirement.

FIG. 10 shows a loading strip 1001 carrying prior art staples 100. This loading strip 1001 can be placed on a device (not shown in FIG. 10) that creates the desired deformation zone and cuts the staple legs 102 to the desired length. Means well known in the art can be used as a device that can be used for such purpose. Loading strip 1001 is staple 10
Prior to inserting 0, insert into stepper (not shown in Figure 10) as appropriate.

FIG. 11 shows another embodiment of the present invention. In this aspect,
The deformation zone is formed when the staple is inserted rather than before the staple is used. The device of FIG. 11 shows stepper jaws 1102, 1103 with staples 1110 therebetween (stepper jaw 1103 functions as an anvil.) Two bars 1101 are used to form the zone of deformation. The bar may be attached to the lower jaw 1103 or the upper jaw 1102. The particular method of mounting the bar is not shown in FIG. 1 for convenience of description and is not critical to the operation of the invention,
Means well known in the art can be used for such purpose.

As the jaws 1102 and 1103 move toward each other, the staples 1110 abut each bar 1101 and bend and deform thereabout. As can be seen from FIG. 12, the leg portions 1111 of the staple are as opposed to each other such that the deformation zones are formed prior to staple insertion, such that the leg portions 1106 and 1107 bend (preferably at right angles). Similarly, it is transformed.

The anvil is preferably moved after the legs of the staple have partially or completely passed through the staple. After the staples are deformed, the bar may move to its side for easy removal of the stepper, or the stepper may be installed to slide out of the staple in one direction from the plane of FIG. Means for enabling such disengagement are not shown, but means known in the art can be used for such purpose.

FIG. 13 shows a side cross-sectional view of another embodiment including staple 10 that can be placed on tissue 12. The legs 26 of the staple 10 are each first
It includes an upper deformation zone 18 surrounded by the section 16 and the second section 20, and a lower deformation zone 24 surrounded by the third section 22 and the second section 20. The staple 10 includes a crown 14.

When the stapler 10 is inserted by the stepper (not shown), the tip end portion 23 of the leg portion 26 penetrates the tissue 12 to be stapled and abuts on the stepper anvil (not shown),
The third section 22 is rotated upward as 26 bends and deforms in the lower deformation zone 24. This allows the second section 20
And the third section 22 forms an angle with each other,
For example, they are substantially perpendicular to each other. When the stepper continuously presses the staple 10 against the anvil,
The legs 26 bend inward and deform in the upper deformation zone 18, whereby the second section 20 rotates with respect to the first section and forms an angle with respect to the first section. For example, it becomes a substantially right angle. It is preferable that the leg portion 26 first bends in the lower deformation region 24, and that the lower deformation region has a stronger tendency to bend than the upper deformation region.

When the staple placement process is complete and the legs 26 are deformed, the third section 22 is penetrated into the tissue 12 as shown in FIG. Of course, the amount of penetration into the tissue 12 depends on the position of the lower deformation region 24 with respect to the tip 23 of the leg 26. Ideally, the upper deformation zone is positioned so that the lower deformation zone 24 is almost in contact after complete deformation. This prevents the tissue from protruding from between the staple legs 26.

Note that the area occupied by each staple is uniformly compressed. In this way, it can be observed that each of the entire stapling areas is uniformly compressed and divided into a plurality of areas.

FIG. 14 shows the staple 10 of the present invention prior to placement on the tissue 12. The staple 10 is U-shaped before deformation and has an upper deformation area 18 and a lower deformation area 24 on each leg 26. Deformation area 18
And 24 can be formed by reducing the above sections of legs 26 of staple 10 or by other methods described herein.

By forming three different sections 16, 20 and 22 on each leg 26, the third section 22 allows a slight penetration of the tissue 12, ie controlling and minimizing the amount of tissue damage. , Thereby reducing the amount of scar tissue formation,
And the second section 20 and the first section 16 are organized 12
Can be used for uniform compression.

FIG. 15 shows a prior art B-shaped staple 28 installed in a tissue 38.
Is shown. Below the end 34 of the leg 32 is a void region 36 of tissue, and scar tissue is formed in this void region to be filled. The separation of the leg 32 from the crown 30 of the staple 28 is not uniform over the length of the leg, so the compression of the tissue 38 by the leg is not uniform. For this reason, hemostasis is often difficult to achieve, and proper use of B-staples requires proper nutrition of the stapled tissue. A disadvantage of B-shaped staples is that the ends 34 of the legs 32 penetrate deeply into the stapled tissue and twist as the legs deform, resulting in substantial damage during staple placement, resulting in stenosis. Excessive scar tissue, which may develop into, is created and bleeding from perforated blood vessels. Furthermore, the healing period will be prolonged.

For purposes of illustration, as shown in FIG. 16, the “inside” 401 of the staple leg 26 and the “outside” 402 of the staple leg 26 are shown.
It is necessary to distinguish between and. Regarding the notch on the inside of the leg of the staple, Figure 16 shows two such notches,
One notch on each leg 26 is used to form the upper deformation zone 18. The lower deformation zone may or may not be used, and when used, the above description of the upper deformation zone is applicable to the variable area although not shown for the purpose of explanation. The notches should not be overly "sharp", otherwise the staples will fail, i.e., break or break, when the leg sections 16 and 20 rotate relative to each other or continuously.

To make an acceptable notch on the inside of the leg,
The radii of the articulating contacts on either side of the notch are small enough that the material forming the staple, for example metal such as stainless steel or titanium, will break, crack or crush during leg deformation in the deformation region of interest. must not. Notches lead to so-called stress concentration. That is, it produces a local stress that is significantly greater than the average stress in that section. Local flexibility of ductile staple material minimizes stress concentration effects, while staples used in surgical procedures require critical use where staple failure is unacceptable as it is dangerous to the health and well-being of the patient. And Failure in stapling due to stress concentration generated at the sharp notch connecting contact formed on the inside of the leg when bending is unacceptable,
The minimum radius must be at the notch contact point.
Minimum radius (fillet) is at least 2/1000 inches (about 5/1000
cm). Not a sharp cutout,
At least 3/1000 inches on the inside of the legs
It is preferred to produce staples with notches having fillets.

FIG. 17 shows an enlarged view of the upper deformation area 18 in the leg 26 in the form of a notch with fillets 40 at the contact points on both sides 42 of the notch. R is the radius of the fillet, and in order to eliminate the possibility of breakage or crushing of the staple leg due to bending when stapling is set to an acceptable reliability, that is, in order to eliminate the subsequent crushing of the leg after installation. More than 3/1000 inches (about 8/1000 cm).

While the above description relates to the preferred embodiment of the present invention, various modifications or alterations will be apparent to those of ordinary skill in the art. For example, staples can be used in other applications besides surgery. Staples with more than one leg can be used, for example staples with one leg between two outer legs, the additional legs not requiring any deformation zones.

Although the above disclosure describes the use of surgical staples, such staples have other uses, such as where uniform compression of an object underlying the staple is beneficial and where perforation of the staple is detrimental. Can be used for

Although particular anvils have been illustrated in this disclosure, the anvils used in the staples of the present invention do not necessarily require any of the illustrated anvils and deform the legs relative to each other to form the desired deformed shape. Means for stopping the deformation of the staples after the desired amount of deformation has occurred. Further, while staples having two legs have been described, the principles of the present invention are applicable to staples having two or more legs, such as intending to compress a larger area with each staple. It is obvious that it can be used for various purposes. Such modifications and / or additions that fall within the scope and spirit of the invention should be protected by the following claims.

Claims (15)

(57) [Claims] 1. A staple having a crown and two legs, each leg being substantially perpendicular to the crown, having a tip, having a predetermined length and including an elongated deformation zone, The elongated deformation region has a start portion and an end portion, extends along a part of the length of the leg portion, and the start portion and the end portion when the leg portion deforms at a substantially right angle in the deformation region. The portions have a length that does not contact each other, and is a region that is more easily bent than the leg region adjacent to the deformation region when the distal ends of the legs are biased against each other, the crown Staple pusher means for pressing to bias the legs of the staple toward biological tissue;
And an anvil means for exerting a force parallel to the crown on the tip of the leg and a force in the reciprocal direction of the leg, such that the tip of the leg penetrates biological tissue and Surgical device characterized in that the force increases when the staple pusher means biases the staples against the anvil means to form a substantially right angle in each of the elongated deformation zones. . 2. A crown and two legs, each leg being substantially perpendicular to said crown,
The elongate deformation region includes a tip portion, has a predetermined length, and extends along a part of the length of the leg portion, and the elongate deformation region has a start portion and an end portion. When the tips are urged against each other, they are more likely to bend than the leg regions adjacent to the deformation zone, the leg portions deform at a substantially right angle in the deformation region, and the start portion of the deformation region A surgical device characterized in that the ends are of a length such that they do not touch each other. 3. A stapling apparatus having the following structure: at least one staple, said staple including a crown having a predetermined crown length and at least two legs, each of said legs being at least 1; Two deformation zones, the at least one deformation zone being formed as a first part of the leg and more easily bent than the adjacent leg zones, each leg being adjacent to the at least one deformation zone and A second part located between the at least one deformation zone and the tip of the leg, and a second part adjacent to the at least one deformation zone and between the at least one deformation zone and the crown 3 parts, said 2nd part and 3rd part have predetermined length, the length of the 2nd part of the 1st leg of said at least 2 legs, and the 2nd of said at least 2 legs leg The length of the second portion, when summed, is substantially equal to the crown length of the crown, a staple pusher for biasing the staple against the tissue to be stapled, the staple pusher on the crown of the staple. An anvil arranged to exert a force, said anvil being in contact with the tip of each of said legs such that the second part of said first leg is relative to the third part of said first leg. First leg of the first leg until a substantially right angle is formed.
A portion of the second leg is bent and the first portion of the second leg is bent until the second portion of the second leg forms a substantially right angle with the third portion of the second leg. At least 1
It is characterized by including, including two channels. 4. The stapling apparatus according to claim 3, wherein at least one of the deformation areas includes a portion having a smaller moment of inertia than a peripheral area of the leg portion. 5. The stapling apparatus of claim 3, wherein each of the legs includes a unique zone of deformation. 6. A crown and a staple having two legs, each leg being substantially perpendicular to the crown,
An elongated deformation zone having a tip and having a predetermined length and along a portion of the length of the leg, the elongated deformation zone being a force parallel to the crown and a force in the mutual direction of the legs. And an elongate region having a deformation resistance smaller than that of a leg region adjacent to the deformation region when applied to each tip of the leg, the crown is pressed to biologically move the tip of the leg. Staple pusher means for pushing into the tissue, and for applying the force on the tip of the leg to deform the leg of the staple when pushing the tip of the leg into the biological tissue Surgical device comprising an anvil means of. 7. A crown and a staple having two legs, each leg being substantially perpendicular to said crown,
An elongated deformation zone having a tip and having a predetermined length and along a portion of the length of the leg, the elongated deformation zone being a force parallel to the crown and a force in the mutual direction of the legs. Includes an elongated region that is more deformable than a leg region adjacent to the deformation zone when applied from the crown onto a portion of the leg located opposite the deformation zone, the elongated region being substantially stationary. Staple pusher means for pressing the crown to push the tip of the leg into the biological tissue, including the elongated portion of the cross section of the cross section, and pushing the tip of the leg into the biological tissue and pushing the tip of the staple into the biological tissue. A surgical device comprising an anvil means for exerting the force on the tip of the leg when biased to deform the leg. 8. The apparatus of claim 6, wherein each said elongated region has a substantially constant cross section. 9. A crown and two legs, each said leg being substantially perpendicular to said crown,
An elongated deformation zone having a tip, having a predetermined length and extending along a portion of the length of the leg, wherein the elongated deformation zone has a force parallel to the crown and is Surgical staple comprising an elongated region having a smaller resistance to deformation than a leg region adjacent to the region of deformation when applied to the tip of the leg in a direction relative to. 10. A crown and two legs, each said leg being substantially perpendicular to said crown,
A tip portion, having a predetermined length and including a deformation zone, the deformation zone including an elongated region, wherein the elongated region has a force parallel to the crown and a force of the legs in a mutual direction. Is a region more easily deformed than a leg region adjacent to the deformation region when applied to a part of the leg portion located on the opposite side of the deformation region from. 11. The staple of claim 9 wherein the deformation resistance is substantially uniform along the elongated region when the force is applied to the tip of the leg. 12. The staple of claim 9, wherein the elongate region has a substantially constant cross section. 13. The staple of claim 10, wherein the elongate region has a substantially constant cross section. 14. Each of the elongated deformation zones includes a start portion and an end portion, the start portion and the end portion being located on opposite sides of the elongated deformation zone, each elongated deformation zone being defined by the anvil means. 7. The device according to claim 6, wherein after the leg is deformed, its start portion and end portion are formed so as not to contact each other. 15. Each of the deformation zones includes a start portion and an end portion,
The start portion and the end portion are located on opposite sides of the elongated deformation area, and each deformation area is formed so that the start portion and the end portion do not contact each other after the leg portion is deformed by the anvil means. 9. The device of claim 8 which is provided.