JPH05504498A - Suture using shape memory alloy - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

[Detailed description of the invention] Suture using shape memory alloy The present invention relates to surgical sutures using shape memory alloys.

Alloys with shape memory are known. Articles made of such materials must be It can be deformed from an undeformed shape to a second deformed shape. Such items are , returns to its undeformed shape under certain conditions.

These are said to have shape memory. The deformed shape of an article with shape memory The only set of conditions that allow recovery to an undeformed shape or configuration is the application of heat. That's true. In this case, the substance has an initial thermally stable form and a second thermally unstable form. It is said to have. The alloy is thermally unstable at temperatures where it is primarily in the martensitic phase It is formed into a shape. By applying heat, articles formed of such materials can be to return or attempt to recover from a thermally unstable shape to an initial thermally stable shape. Can be done. That is, it "remembers" its initial shape.

In metal alloys, the ability to have shape memory is primarily due to the ability of the alloy to decrease in temperature. reversible transition from an austenitic state to a mainly martensitic state. This is the result. This transition is sometimes referred to as a thermoelastic martensitic transition.

Articles made of such alloys are characterized in that the alloy is in a primarily austenitic state. The initial form when cooled below the temperature at which it transitions to the martensitic state as easily transformed from one shape to a new shape. The temperature at which this transition begins is usually called MS. , the temperature at which the transition ends is usually referred to as Mf. The article deformed in this way is (Af is the temperature at which the reverse transition is completed), when the alloy is in the austenitic state. When heated to a temperature at which it begins to return to , the deformed article returns to its initial shape. start. Many shape memory alloys (SMAs) have stress-induced martensite (SI) M). Sample SMA showing such a SIM In addition, Md (stability) is greater than or equal to Ms (therefore, the austenite state is initially stable) Stress is applied below the maximum temperature at which martensite formation can occur even under stress. When applied, it first begins to deform elastically and then undergoes critical stress to form a SIM. The metastasis begins. Deformed steel depends on whether the temperature is above or below As. Behavior is different when the dress is relaxed. If the temperature is below As, the SIM is safe. However, when the temperature is higher than As, martensite is unstable and Reversing to austenite while the pull returns (or attempts to return) to its initial shape move. This effect indicates a thermoelastic martensitic transition accompanied by a thermoshape memory effect. Found in almost all alloys. However, the temperature range in which SIM can be seen The degree of stress and the range of deformation to exhibit this effect vary widely depending on the alloy. change.

Various proposals have been made for using shape memory alloys in the medical field. for example, U.S. Pat. No. 3,620.212 to Fannon et al. U.S. Patent No. 3.7 to Johnson et al. No. 86.806 proposed the use of SMA bone plates, and Wilson, US. National Patent No. 3.890.977 describes an SMA element for bending a catheter or cannula. No. 4,485,816 to Krumme proposed the use of is a shape memory surgical stay used to hold the edges of a wound closed until it has healed. The Baumgart U.S. patent discloses the use of No. 4,170.990 is a wire and disc clamp for straightening post laterals. Indicates the use of SMA for medical purposes such as rods and intermediate rods.

Also, U.S. Patent No. 4.665.906 to Jervis A medical device that utilizes the pseudo-elasticity (SIM) property of memory alloys is disclosed.

These medical SMA devices rely on shape memory properties and are sensitive to temperature and stress. The desired effect is achieved when the stress is relaxed. That is, they depend on the SMA If the element is cooled to the martensitic state and then subjected to deformation or stress is applied, which causes part of the SMA to become martensitic. It retains its original shape, but is heated to an austenitic state by the case or is heated to an austenite state. When the response is removed, the element returns to its initial shape. .

Currently, the techniques used to keep wound edges closed until healing include three There are two different methods. The oldest and most widely used method is the flexible It uses thread, which is passed through the combined tissue edges and tied. this Such threads can be made of rope or synthetic polymeric materials. In such threads , and others are gradually absorbed into the human body, but the doctor must remove them after treatment. There are things that must be done. The second method is by using a metal stable. , which is attached across the combined tissue edges and bent further inward to protect the wound edges. Holding and preventing the stable from falling off.

The last method is by band or strip; Place across the wound and secure the skin with an adhesive backing, stabilizer, or suture. held on the surface.

Metal stables and bands or strips generally close only the surface of the wound and Does not keep the deep medial edge of the mouth properly closed.

Sutures alone provide the critical ability to hold the deep medial edges of the wound together . If the deep inside of the wound is not kept closed, fluid will accumulate and the body's defense mechanism This ability is critical, as infections can occur in areas that the system cannot handle. be. And this is the same force that tries to close the edges of a wound by tying it in place. Currently, flexible sutures are used to apply shearing force that acts from the deep part of the wound to the surface. is used. This shear force causes the wound edges to wrinkle or bend apart. This may prevent proper alignment of the wound edges, which is not desirable. It's not. As a result, sutures can be used in two or more layers, with one layer underneath the other. It is necessary to properly close the deep wound. Also, the skills of individual surgeons , to determine how well current flexible sutures can keep wounds closed.

A series of consecutive suture knots are then tied to provide the best wound closure. Properly applying the bundle to the wound is difficult and time consuming.

The present invention aims to solve the problems mentioned above and more.

In one aspect of the invention, in a tissue of a patient (human or animal), the tissue is demarcated by the edges of the tissue. We will discuss the sutures used to close the wound shown. The suture has a first end; an alloy member having a second end and a first undeformed shape. This is the second It can be transformed into a modified shape. The member having the second shape is It has the property of recovering to the first shape when placed under conditions. first form The shape is a suture adapted to pull the tissue edges at the wound border and keep them together. It has a doubling loop shape. The second configuration allows the member to recover to the first configuration and bring the tissue edges together. the first end of the member into the tissue in such a way as to draw it into the It is adapted to the sea urchin.

In another aspect of the invention, the patient's tissue is delimited by tissue edges. We will explain how to suture the wound. This method involves moving the member, which is in the second shape, The member is first inserted into the tissue adjacent to the tissue edges demarcating the wound as described above. It consists of inserting it into the position of the reservoir to restore it to its shape. The first part of this causes recovery of the suture loop shape, thereby pulling the tissue edges of the wound together and bringing them together. It is placed under conditions that keep it in a stable condition.

The shape memory alloy suture according to the present invention solves all the problems of the prior art mentioned above. be able to. These are useful for keeping the edges of deep wounds together and is different from staples and bands or strips. This requires unity and does not generate any shearing force between the deep part of the wound and the surface. different from sutures. Additionally, such sutures are generally removed after the wound has fully healed. can be easily removed. Such sutures, when placed across the wound, If the wound is damaged, try to pull the tissue edges together and maintain the pulling motion until the wound heals. Maintain your condition. Conventional sutures were required in multiple layers to close thick layers of tissue whereas this can close thick layers of tissue using a single set . And there is no need for tying to ensure wound closure.

When using traditional sutures, they typically start deep in the wound and close to the surface of the tissue. Multi-layered sutures are required, working upwards towards the This means that the surgery time It requires quite a bit more. Furthermore, the sutures of the present invention do not require tying; saves considerable time in closing wounds. Save time by shortening surgery time This reduces the risk of anesthesia and reduces the time the wound remains open, reducing the risk of infection. This reduces the risk of surgery for the patient.

Short wound closure times also reduce the total time patients spend in the operating room. , can save patients money.

In example embodiments, the present invention utilizes shape memory properties to achieve desired effects. to be accomplished. The SMA device of the present invention induces a change from its deformed shape to its undeformed shape. The condition that causes this is the effect of temperature, that is, the transition from martensite to austenite. Heating the SMA to a temperature that causes This reduces the stress of maintaining the austenitic state, which further reverts to the austenitic state. It is either to let. These effects can be used in combination . All of the example embodiments of the sutures of the invention described below utilize these two types of shape memory alloys. There is potential to exploit any of two different shape memory properties.

If SMA is used, this is typically a nickel-titanium based alloy; The yield strength obtained from gold, or in particular the desired pseudoelastic properties and temperature shape transition properties. Additional elements can be included that affect the temperature obtained. For example, in this case Gold is a binary alloy consisting essentially of nickel and titanium, e.g. nickel-50 ．． 8 at.% titanium, 49.2 at.% titanium, vanadium, chromium or iron. It can also contain a third element such as. Disclosed in U.S. Patent No. 4.505.767 An alloy consisting essentially of nickel, titanium and vanadium, as shown in Nonlinear pseudoelastic properties at or near body temperature It works very well for many applications. Also, copper Based alloys, e.g. alloys consisting essentially of copper, aluminum and nickel, copper Alloys consisting of aluminum, aluminum and zinc, and alloys consisting of copper and zinc may also be used. I can do it.

The invention can be better understood by referring to the drawings. same number Numbers indicate the same parts.

FIG. 1 shows a suture of the invention in a loop configuration with a needle attached.

FIG. 2 shows the suture of the present invention in a looped configuration in its final position across the wound.

FIG. 3 shows a suture of the present invention with an insertion guide.

FIG. 4a shows an example embodiment of a suture of the present invention.

FIG. 4b shows another example embodiment of a suture of the present invention.

FIG. 5 shows the suture of the present invention in a deformed state and two different undeformed forms. Indicates the condition.

FIG. 6 shows an example of an embodiment of a suture of the invention in a deformed state and two possible different versions. The figure shows the undeformed shape.

FIG. 7 shows an example of an embodiment of a suture of the invention in a deformed state and three different possible The figure shows the undeformed shape.

FIG. 8 shows yet another embodiment of the suture of the present invention.

FIG. 1 shows an example embodiment of a suture 10 according to the present invention. The suture 10 shown in FIG. It is made of the shape memory alloy mentioned above. This is mainly in the austenitic state, and the main In the figure, the loop 12 is included.

The suture 10 shown in FIG. 1 includes a member 1 in the form of an alloy strip or wire. 8 includes a needle 14 attached to or formed on a first end 16 of the needle. Alloy strip or The wire may be of any convenient cross-sectional shape and size; It may have different cross-sectional shapes and dimensions at different positions in the length direction. What is needle 14? The diameter of member 1 is generally the same, although it may be of any convenient shape or radius of curvature. 8 follows needle 14 within the tissue, equal to or close to the maximum cross-sectional diameter of member 18. greater than .

Needle 14 may be drawn, crimped, welded, or soldered onto first end 16 of member 18. or can be attached by other methods. The needle 14 is attached to the first end 1 of the member 18. 6, it can be attached so that it will come off when pulled suddenly. Instead, the member 18 sharpens itself (and hardens as much as possible) so needle 14 is not needed You can also do it like this. If desired, insert member 1 into the eye (not shown) that needle 14 has. attaching the needle 14 to the member 18 by threading the first end 16 of the needle 14 through the member 18; Can be done.

As already mentioned, the member 16 has the pseudoelastic properties of shape memory alloys or the temperature of SMA. It has the benefit of either induced shape memory changes or a combination of these two properties. pseudoelasticity The shape shown in FIG. 1 for the suture is the undeformed loop shape. has this shape As long as the stress continues to be applied to the member 18, the member 18 changes to the martensitic phase. The austenite phase portion can be easily stretched by hand. Deformation force (stress ), the martensitic phase of the suture 10 immediately becomes austenitized. While inversely transitioning to the top phase, it pseudoelastically returns to its original form shown in Figure 1, that is, the loop shape. Ru.

In use, sufficient stress is applied to the suture 10 of FIG. 1 so that it pierces the tissue 24. Sew the tissue 24 around the wound in the usual manner until it is sufficiently straight and deformed to pass it through. This brings the edges 20 and 22 of the wound together as shown in FIG.

When the stress is removed, the suture 10 changes from the martensitic phase to the austenitic phase. The same shape as shown in Figure 1 is formed due to the springback due to the pseudoelastic elastic A loop 12 is formed. Upon insertion of suture 10, metastasis may actually occur.

The tissue 24 itself helps to straighten the suture 10 as it is threaded. can be done. Loop 12 appears to be circular and is generally designed as such. However, it can also take other shapes, such as an oval or a square. You should be careful. Loop 12 is added to bring wound edges 20 and 22 together. will be fixed in its final shape unless the desired abutting force exerts harmful shear forces. . Suture 10 is pseudoelastic and thus easily deforms, and member 18 is Temporarily add enough martensite to resist the weaving from forming loops 12. It will stay in place and you will be able to thread the thread in place. Therefore, suture 1 8 slides easily through the tissue 24.

The needle 14 is then cut or otherwise removed, typically at the first end of the member 18. along section 16 and, in certain embodiments, along second end 26 of member 18. 2, thereby leaving the end segment 28.30 shown in FIG. loop 12 is formed and the wound edges 20 and 22 are drawn together. End segment 28.3 o has its curved original (undeformed) shape. End segment 28.30 is , the wound can be engaged manually or with an instrument to close the wound, if desired. . However, such engagement is not essential (although other aspects of the invention does not require such engagement.

Cut and remove one or both of the sutures 10 and slide the remaining suture 10 out of the tissue. can be done.

FIG. 3 illustrates one example embodiment of the present invention in which a rigid sleeve 32 is attached to a suture 10. is maintained in a shape that extends relatively in the length direction. In the embodiment shown in FIG. Sleeve 32 can be used to pass 4 directly into tissue. Three The tube 32 can also have a pointed end and is used to push the member 18 into tissue. I can be there. As a pseudoelastic suture 10, the needle 14 is inserted into the sleeve 32. It should be supported by the sleeve 32 so that it does not rotate against it. Furthermore, i The long axis portion of the needle 14 connected to the doubling thread 10 can be freely moved relative to the long axis of the sleeve 32. It shouldn't be. Once the needle 14 is properly inserted into the tissue 24, the suture 10 can be further advanced by a device such as a conventional needle holder (not shown). , the sleeve 32 is easily removable from the second end 26 of the member 18.

The example embodiment of FIG. 2 shows a suture 10 that has transitioned from an austenitic state to a predominantly austenitic state; You can also do it. Figure 1 shows loop 1 in the position it would be used when inserted into tissue. 2 indicates the suture 10 in a primarily austenitic state, that is, in an undeformed state. It can be interpreted as Such a suture 10 can be used, for example, in cold water, cold salt water, etc. Immersion in cooling media such as saline, liquid nitrogen, ice, and liquefied carbon dioxide It is possible to cool down to the desired temperature, which was conventionally used, by It can be done. Once the suture 10 has cooled, it will physically straighten; is inserted into tissue 24, for example as shown in Figure 4a. Due to the relatively low temperature Suture 10, in its relatively flexible state, can be easily passed through tissue 24. Sewing Once the suture 10 is in position across the wound, the needle 14 and perhaps a portion of the end 16 is cut. Cut and remove. The remaining portion of suture 10 is warmed to body temperature. Instead, By purchasing a warm object for the suture 10, place it and the eccentric part in a warm medium. By immersing it in water or by passing an electric current through it and generating heat due to electrical resistance, Suture 10 can be further warmed. At least the increased temperature of suture 10 However, SM and A mainly return to the austenitic state, which causes the suture thread 10 to The shape shown in FIG. 2 is reassumed, so that the loop 12 is reconfigured. suture 10 When passing through the tissue 24, some kind of recovery to the austenitic state is mainly performed. can occur.

Furthermore, with respect to FIGS. 4a and 2, forming the loop 12 allows the wound edges to 20. Indicates pulling 22 into contact.

Cut the needle 14 and any unnecessary portions of the ends 16 and 26 of the member 18. After cutting, engaging the remaining end segments 28.30 by hand or using an instrument; This allows the wound to be reliably closed. Alternatively, before removing the needle The end segment 28.30 can be engaged with the end segment 28.30.

The suture 10, which recovers to its undeformed shape as the temperature increases, is formed into a rigid sleeve as shown in FIG. 32 is advantageously used to effect the restraint. The hard sleeve 32 is used during storage or heat sterilization. A premature rise in temperature somewhere in the body causes a change in shape memory. prevent. When using suture 10, it should be properly cooled along with sleeve 32. It can be immersed in a medium or refrigerated. In this way the sleeve has sutures 10 can be removed just prior to positioning it within tissue 24.

Alternatively, sleeve 32 can be used as a direct driver for threading needle 14 into tissue 24. can be used. Sleeve 32 stores the suture relatively cool and keeps it in shape. It can act as a heat reservoir to delay memory changes from occurring. this allows the deformed suture to take more time to enter the tissue.

Sleeve 32 may have a pointed end to push member 18 into tissue 24. It can also be used for insertion. In such cases, the needle 14 is generally The first of the members 18 should be retained by a sleeve 32, thereby preventing relative rotation. The long axis of needle 14 connecting to end 16 is less flexible than the long axis of sleeve 32. . Once the needle 14 is properly positioned within the tissue 24, the suture 10 is placed in a conventional needle holder ( (not shown) etc.! The sleeve 32 can be advanced further by the member 18. It can be simply slid off at the second end 26 of.

Once suture 10 is in the configuration shown in FIG. 4a, needle 14 and generally the first end 16 and the remaining portion of suture 1o (with body heat and/or ). The remaining suture ends 28.30 are engaged as shown in FIG. can be combined.

Instead, after engaging the end segment 28.3o, the needle]4 and the first The ends can be removed.

The example embodiment of FIG. The second end 26 of member 18 having 33 is shown. The protrusion 33 connects the suture 10 to the tissue. as a stop at the surface 34 of the tissue 24 when the needle 14 is pulled through the tissue 24. work. The protrusion 33 abuts the tissue surface 34 and does not easily cross this surface. . Alternatively, as shown in Figure 4b, suture 10 is machined similar to protrusion 33 in Figure 4a. The second end 26 can have a sharp bend 36 that allows the second end 26 to be bent. Figures 4a and 4b In the example embodiment of FIG. end segments 28 and 30 that can be engaged with each other; Ru.

Figures 5 to 8 show the changes from the deformed shape to the undeformed shape by stress relaxation or heating. 3 illustrates another example embodiment of an SMA-dependent suture 10 that pseudo-elastically transfers to a tissue. Figure 5 -8, the needle 14 has already been removed and the first end 16 and second end of the member 18 The excess portion of section 26 is also removed in the same manner. In each figure, the part marked rAJ The figure shows that the pseudoelastic effect and heating are still occurring when the suture 1o is passed through the tissue 24. The shape of the suture thread 1o before recovery to the deformed shape is shown.

The partial view marked rBJ shows the pseudo-elastic or heating-induced transformation of the suture 1o to the undeformed state. 3 shows another shape of the suture 1o after the transition has occurred.

FIG. 5 shows that in the partial view B1, SM, A is the curvature half of at least a portion of the suture thread 1o. act to reduce the diameter and bring tissue edges 2o and 22 together and/or Indicates the situation in which it is maintained. In the embodiment of partial view B1 of FIG. 5, the end segment The grooves 28 and 3o are sharply curved and wound generally facing inward to the wound. Figure 5 In the embodiment of partial view B2, the end segment 28.3o bends sharply; Generally facing outward, away from the wound. End segments 28 and 30 are The tissue surface 34 may or may not be contacted or actually penetrated. end Segments 28 and 30 need not bend in the cardinal plane of the main portion of suture 10. The ends 28 and 3o are bent opposite the cardinal plane of the main portion of the suture 10. It's okay. Importantly, end segments 28 and 3o are connected to the main portion of suture 1o. Sometimes it is desirable to bend in a plane perpendicular to the fundamental plane of the part. That's what I mean.

Partial views B1 and B2 of FIG. 6 show two further embodiments of the suture 1o using SMA. shows. In the embodiment of FIG. 6, the SMA has a curvature half of at least a portion of the suture to reduce the diameter and keep the tissue edges 2o and 22 drawn together and/or together. There is a tendency to The end segments 28 and 30 are different from each other compared to the example embodiment of FIG. , as shown in partial view B1 of FIG. or even more curved as shown in partial view 82 of FIG. It is wound further outward so as to move away from it. Examples of embodiments of these suture threads 10 The end segments 28 and 30 have their respective tips 38 and 40 connected to the tissue. It is intentionally bent sufficiently so that it does not touch or penetrate surface 34. this is, Penetration of tissue surface 34 by respective tips 38 and 40 of end segments 28 and 30 Minimize intensity. As in the embodiment of FIG. It is not necessary to bend the sections 30 in the cardinal plane of the main portion of the suture 10.

FIG. 7 shows three additional embodiments of suture 10 using SMA.

The SMA, as in other embodiments of the invention, has a curvature radius of at least a portion of the suture 10. The diameter is reduced and the tissue edges 20 and 22 are pulled together and/or brought together. functions to maintain However, ends 16 and 26 intersect each other, and both ends Each tip 38.40 of 16.26 is on the opposite side of the wound (: 12.Fig. In the embodiment shown in FIG. 7, partial view B], the ends 16 and 26 are 8.40 is bent to contact or penetrate tissue surface 34. Partial view of Figure 7 In the embodiment shown in B2, end segments 28 and 3 of ends 16 and 26 0 is more sharply curved than the rest of the suture 10, and the end segment 28 and 30 so that their respective tips 38 and 40 do not contact or penetrate the tissue surface 34. It is generally wrapped towards the internal wound. This treatment also minimizes tissue irritation. become

In partial view B3 of FIG. 7, end segments 28 and 30 have tips 38 and 4 0 away from the tissue surface 34 so as not to touch or penetrate the tissue surface 34. It's wrapped. As with other embodiments previously discussed, end segments 28 and 30 are It can be bent in any desired plane.

FIG. 8 shows the suture 1o being traversed across the wound in more than one stroke.

In particular, FIG. 8 shows the suture 10 being placed across the wound in two passes. deer However, the number of strokes of suture 10 can be set to any number, so that What is known as a "running suture" There is also. Once suture 10 is in place, its end segments 28 and 30 are It may take any of the shapes shown in other embodiments of the invention. Instead, as in Figure 4a It may also be a sharp protrusion 33 or a sharp bend as shown in FIG. 4b. Other aspects already mentioned Similarly to the example, in this example, the transition from a low austenitic state to a high austenitic state The transition of the SMA is such that the radius of curvature of at least a portion of the suture 10 is reduced. function and thus keep tissue edges 20 and 22 together and/or together Become something. Partial view A of FIG. 8 shows the suture 10 in place, but at the wound edge 2. 0 and 22 are not yet attracted to each other. On the other hand, in partial view B, the suture thread 10 is An example of an embodiment in an undeformed shape that is mainly austenitic is shown. everything explained In example embodiments, the suture 10 is threaded through a portion of sufficient thickness of each tissue edge 20.22. It can be designed to be located deeply. This method allows single-layer sutures Tissue edges 20 and 22 are pulled together and/or brought together using a thread. can be kept in good condition.

According to the method of the present invention, when member 18 is in a deformed, longitudinally elongated configuration, , the member 18 of the tissue 24 adjacent to the tissue edge 20.22 delimiting the wound is undeformed. wound by inserting the member through the member into position in the form of a suture loop 12. The tissue edges 20.22 of the mouth can be sutured.

Member 18 is subjected to conditions that cause it to return to the undeformed suture loop shape 12. The tissue edges 20.22 of the wound are thereby drawn together and held together.

The conditions to which member 18 is subjected include raising the temperature of the alloy to the patient's body temperature or even higher. This causes the suture 10 to leave its deformed shape and return to its undeformed shape. to take action. To transfer the suture thread 10 from a deformed shape to an undeformed shape When using temperature, the suture 10 can be deformed and its shape By cooling the suture 10 to a temperature that will maintain its deformed shape, Then, apply sufficient stress to make it assume the desired deformed shape. be able to.

Another step in which the suture 10 undergoes a transition from the deformed shape to the undeformed suture loop shape 12 The conditions allow a phase change from martensite to austenite with a change in shape. 18 to remove sufficient stress from the member 18 to accommodate the A place like this The suture 10 is generally in a stressed and deformed shape at ambient temperature. It is in. This deformed shape allows the suture 10 to be inserted into the tissue 24 due to the resistance of the tissue 24. and can be maintained until the suture 10 crosses the wound. Wear. Upon removal of the stress, suture 10 then assumes a looped configuration.

The present invention draws and/or keeps the tissue edges 20.22 of the wound together. A suture 10 is provided.

Although the invention has been described with respect to particular embodiments, further modifications and variations are possible. This application has been made generally in accordance with the principles of the invention and in the technical field to which the invention pertains. books that have become publicly known or customarily practiced, and the aforementioned books. as applied to qualitative features, as well as limitations on the scope of the invention and the appended claims. Any modification of the invention, including modifications departing from the disclosure of the invention, as may be included within the scope. It will be understood that any further modification, use, or application is intended.

abstract sutures and The suturing method will be described. The suture has a first end, a second end and a first undeformed shape. It is made of an alloy member with This can be deformed into a second deformed shape. Element changes from the shape of Atsushi 2 by subjecting it to certain conditions while in the second shape. It has the property of recovering to the first shape. In the first shape, the member marks the boundary of the wound. suture loops that can pull tissue edges together and hold them together. It is loop-shaped. The second configuration inserts the member into the tissue at a location forming a loop. It can be adapted to suit your needs. The method comprises: while such member is in the second configuration; , let's make this into the first suture loop shape! and this will lead to the first shape. It consists of adding conditions that cause recovery.

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Claims (14)

[Claims] 1. an alloy member having a first end, a second end, and a first undeformed member. having a shape and capable of deforming into a second deformed shape, the member is subject to certain conditions. It has the property of recovering to the first shape by receiving it, and the first shape is Adapted to draw together and keep tissue edges demarcating wounds together a suture loop configuration, and the second configuration is such that the member recovers to the first configuration and closes the tissue edge. suitable for passing the first end of the member into tissue in a position that maintains the first end of the member together. a suture for suturing a wound in a patient's tissue bounded by a corresponding tissue edge; 2. The suture of claim 1, wherein the second shape is longitudinally elongated. 3. the alloy is primarily in the martinsite phase when the component is in the second configuration; is primarily in the austenitic phase when the member is in the first shape, and under certain conditions is to raise at least a portion of the member to at least the body temperature of the patient. The suture described in item 1. 4. The alloy contains a martinsite phase when the part is in the second configuration, and the part The austenite phase content of the alloy when is in the first shape is the austenite phase content of the alloy when the member is in the second shape When the austenite phase content of the alloy is more than The phase change from the martinsite phase to the austenite phase is carried out to remove stress. 3. The suture of claim 2, wherein the suture is made to a sufficient extent to cause 5. The second end of the member engages the first end of the member when the member is in the first configuration. The stitch according to any one of claims 1 to 4, which is formed into a hook shape suitable for fitting. Doubling thread. 6. The second end of the member is inserted into the second end while the member holds the wound edges together. a hook adapted to engage the first end of the member after recovery to the looped shape of the member; The suture according to any one of claims 1 to 5, which is formed in a shape. 7. The suture according to any one of claims 1 to 6, wherein the loop shape is approximately circular. 8. Claims in which the first end of the member is shaped like a needle capable of penetrating tissue. Item 8. The suture according to any one of Items 1 to 7. 9. Claims including a tissue penetrating needle attached to extend from the first end of the member. 9. The suture according to any one of Items 1 to 8. 10. The second end of the member includes means for preventing passage of the second end into tissue. and the blocking means preferably has (a) a dimension in a cross section of the second end of the member; the larger part of the law, or (b) bend at the second end of the member; The suture according to any one of claims 1 to 9, consisting of: 11. a slide around at least a portion of the member when the member is in the second configuration; Claims 1-1, wherein the member is adapted to maintain the second shape. 0. The suture according to any one of 0. 12. Place the member in a position where the sleeve holds the tissue edges of the wound together. Claim 11 having a pointed penetrating end suitable for penetrating tissue for positioning. Suture as described. 13. The first end of the member is shaped like a needle and extends from the sleeve. The suture according to item 11. 14. a tissue penetrating needle attached to extend longitudinally from the first end of the member; 12. The suture of claim 11, including: the needle extending from the sleeve.